ID,State,Age,Sex,Symptom Description,Died,Date of Death,Life-Threatening Illness,Hospitalized,Days in Hospital,Disabled,Recovered,Vaccination Date,Symptom Onset Date,Days Between Vax - Symptoms,Facility Type,Other Medication,Current Illnesses,Medical History Notes,Prior Vaccinations,Allergies,Symptoms,Dose Number,Manufacturer,Route 916600,TX,33.0,F,Right side of epiglottis swelled up and hinder swallowing pictures taken Benadryl Tylenol taken,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,PVT,None,None,None,,Pcn and bee venom,"['Dysphagia', 'Epiglottitis']",1,MODERNA,IM 916601,CA,73.0,F,"Approximately 30 min post vaccination administration patient demonstrated SOB and anxiousness. Assessed at time of event: Heart sounds normal, Lung sounds clear. Vitals within normal limits for patient. O2 91% on 3 liters NC Continuous flow. 2 consecutive nebulized albuterol treatments were administered. At approximately 1.5 hours post reaction, patients' SOB and anxiousness had subsided and the patient stated that they were feel ""much better"".",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,SEN,Patient residing at nursing facility. See patients chart.,Patient residing at nursing facility. See patients chart.,Patient residing at nursing facility. See patients chart.,,"""Dairy""","['Anxiety', 'Dyspnoea']",1,MODERNA,IM 916602,WA,23.0,F,"About 15 minutes after receiving the vaccine, the patient complained about her left arm hurting. She also complained of chest tightness and difficulty swallowing. Patient also had vision changes. We gave the patient 1 tablet of Benadryl 25 mg and called EMS services. EMS checked her out and we advised the patient to go to the ER to be observed and given more Benadryl. Patient was able to walk out of facility herself.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,SEN,None,None,None,,Shellfish,"['Chest discomfort', 'Dysphagia', 'Pain in extremity', 'Visual impairment']",1,PFIZER\BIONTECH,IM 916603,WA,58.0,F,"extreme fatigue, dizziness,. could not lift my left arm for 72 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,none,kidney infection,"diverticulitis, mitral valve prolapse, osteoarthritis","got measles from measel shot, mums from mumps shot, headaches and nausea from flu shot","Diclofenac, novacaine, lidocaine, pickles, tomatoes, milk","['Dizziness', 'Fatigue', 'Mobility decreased']",UNK,MODERNA, 916604,TX,47.0,F,"Injection site swelling, redness, warm to the touch and itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/29/2020,7.0,PUB,Na,Na,,,Na,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 916606,NV,44.0,F,patient called back the next day and stated her throat was swelling and had to take Benadryl.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,iodine (shellfish) has epipen,['Pharyngeal swelling'],1,MODERNA,IM 916607,KS,50.0,M,"SEVERE chills approximately 13-14 hours after receiving vaccine. Even after turning heat up in the house and wrapping myself in two comforters, I was still experiencing severe chills. These chills lasted for approximately 5-6 hours. I was unable to sleep due to them. I did not have a fever, as I checked my temperature several times during this episode. At approximately 6:00 am on the same day as experiencing the chills, I experienced abdominal pains, which lasted approximately 1 hour and resolved on their own.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PUB,"Amlodipine, Ambien, Benicar/HCTZ, Invokana, Metformin, Levothyroxine, Bydureon, Metoprolol",None,"High blood pressure, high cholesterol, sleep apnea, insomnia, diabetes type II, obesity.",,Penicillin,"['Abdominal pain', 'Chills', 'Sleep disorder']",UNK,MODERNA,IM 916608,OH,33.0,M,Nasal congestion and diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/31/2020,2.0,OTH,None,None,None,,None,"['Diarrhoea', 'Nasal congestion']",1,MODERNA,IM 916609,TN,71.0,F,On day 9 following the vaccination I noticed a red raised itchy patch at the vaccination site approximately 2 in X 2 in. No other symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PUB,"Medication Summary 1/1/21 Name of Medication RX or OTC Doseage Frequency Reason Comment Meloxicam RX 15 mg 1 qd inflammation Synthroid RX 75 mcg. 1 qd, middle of night Thyroid hormone, T4 Liothyronine SOD RX 10 mcg 1 qd,",none,"Hashimoto's thyroiditis, Hypertension, depression",,"Sulfa antibiotics, azithromycin, adhesive in band-aids or tape","['Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site swelling']",1,MODERNA,IM 916610,VA,18.0,F,hives and rash all over body that has not gone away in 2 days since it began,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,,,,,jackfruit,"['Rash', 'Urticaria']",1,MODERNA,SYR 916611,NC,33.0,F,"12pm Received shot 1 pm Sore arm at injection site 8pm loss of appetite, whole arm hurting 11pm fever 101, severe chills, body ache, tiredness 11:30pm-3am fever 103.6, chills, body ache, tiredness, headache, confusion, sore on right side of body, high blood pressure161/96, high heart rate 120?s while resting, slighty sob (O2 low 90?s) slight chest pain on right side under Rib front and back, nausea, tingling lips for about 5 mins maybe. 12-30-20 3am still had fever 101 after taking Tylenol, blood pressure and heart rate decreased a little, chills stopped, was able to sleep 7am fever was 102 nausea headache sore right arm Headache and Fever 102 continued all day, fever was a little lower taking Tylenol 12-31-20 Had headache/pressure in head all day temp 98.6-100 all day, felt a lot better, right arm still a little sore",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,Flonase Zyrtec,"Covid-19 (symptom onset 12-16-20 negative test same day, last day of symptoms were 12-22-20, symptoms resolving, smell started coming back 12-25-20)",Obesity Anxiety,,Dust mites Zoloft Wellbutrin Buspar,"['Blood pressure decreased', 'Chest pain', 'Chills', 'Confusional state', 'Decreased appetite', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Head discomfort', 'Headache', 'Heart rate decreased', 'Heart rate increased', 'Hypertension', 'Injection site pain', 'Musculoskeletal chest pain', 'Nausea', 'Pain', 'Pain in extremity', 'Paraesthesia oral', 'Pyrexia', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 916613,CA,40.0,F,On 12/30/2020 I got a pain in the stomach as if someone kicked me and then a taste of medicine like when you chew a aspirin after taste. But it went away 12/31/2020 I felt dizzy around 3:00pm,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,OTH,None,None,None,,None,"['Abdominal pain upper', 'Dizziness', 'Dysgeusia']",1,MODERNA,SYR 916614,NY,29.0,F,"Elevated HR and Blood pressure. Chest tightness. Blood pressure 154/111, HR 154",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,None,none,None,,None,"['Blood pressure increased', 'Chest discomfort', 'Heart rate increased']",1,MODERNA,IM 916615,NY,38.0,F,"Large red, raised itchy area surrounding injection site. Lymph node in left armpit swollen and painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PVT,"Celexa, tylenol",None,"Migraines, PMDD","20 years old, had similar reactions to flu vaccine. Unknown brand or date.","Sulfa, steri strips, adhesive bandages","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 916617,CA,35.0,F,"Dizziness, chills, fever, muscle aches, pain at the injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,"Fluoxetine 40mg qd, cetirizine 10mg qd Apple cider vinegar pills",,Depression,,None,"['Chills', 'Dizziness', 'Injection site pain', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 916618,GA,24.0,F,"Soreness at injection site, especially when raise arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Injection site pain', 'Pain']",1,MODERNA,IM 916619,NY,28.0,M,"Within two days of receiving COVID vaccine, I began to have a very heavy period. I have been on birth control on and off for many years due to irregular and heavy periods. As such, I have not had a period in years. There was significant clotting and heavy flow associated with the period which lasted about 4 days before subsiding. No other adverse effects aside from muscle pain at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/25/2020,3.0,OTH,Effexor 125mg 1 qd; Adderall XR 10mg 1 qd; Lo Loestrin Fe 1 qd; Requip 0.5mg 1 q PM; Trazodone 50 mg 1 q PM,,,,Sulfa; Wellbutrin,"['Injection site pain', 'Menorrhagia']",1,PFIZER\BIONTECH,IM 916620,NJ,65.0,M,1. Sore arm started several hours later approximately 9 PM 12/29/2020 2. Chills started approximately 12:30 AM on the following day 12/30/2020 3. Severe myalgias and arthralgias with difficulty moving approximately 6 AM 12/30/2020 4. Fever starting approximately 6 AM starting 101.5-1 03 then later in the day 105. 5. Severe headache starting approximately 9 AM 12/30/2020 and persists but much less 6. Nausea starting approximately 9 AM 12/30/2020,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,Aspirin Multiple Vitamins Zithromax,None,Covid 19 infection with lingering symptoms to include chronic dyspnea/O2 dependent at this point.,,None,"['Arthralgia', 'Chills', 'Headache', 'Mobility decreased', 'Myalgia', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 916621,CA,25.0,F,Fatigue - 2 hours prior. Muscle aches/pain - 32 hours prior. Chills - 32 hours prior. Extreme fatigue- 32 hours prior. Headache - 35 hours prior.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,"B-12, Mirena, and collagen.",None,None.,,Ceftiaxone (Rocephin),"['Chills', 'Fatigue', 'Headache', 'Myalgia']",1,MODERNA,SYR 916622,NY,22.0,F,"Felt a little nauseous and a little headache started on December 31st 2020 @ 9:00pm and lasted until January 1st 2021 @ 12:00am. Pain, tenderness, swelling(I have a big bump) and redness of the injection site started December 31st 2020 @ 8:00am until present it?s still going on January 1st 2021. At one point felt like my heart was beating fast started on December 31st 2020 @ 10:00pm until December 31st 2020 @ 10:30pm. Not sure where this falls into might not even have to do with the vaccine sorry if I guy is reading this but I bled all day on December 31st 2020 and I am currently on Birth Control and have been on for 3 years now and haven?t had a female menstrual cycle in about 3 years.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PVT,"Flovent Inhaler, Children?s Multivitamin, Amphetamine Salts(Adderall), Mometasone Nasal Spray",None,"Asthma, ADHD",,Seasonal/Environmental Allergies,"['Headache', 'Heart rate increased', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Nausea']",1,MODERNA,SYR 916623,LA,31.0,F,Soreness at site of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,UNK,"Wellbutrin, Vitamin D3, Zinc Sulfate, Multivitamin, Collagen","Bacterial Upper Respiratory infection(2 weeks ago), husband tested COVID + <1week ago",Anxiety,,Morphine,['Injection site pain'],1,PFIZER\BIONTECH,IM 916624,,27.0,F,"Swelling, warmth, induration, itchy. All about 2"" lower than where the injection was given.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/31/2020,8.0,WRK,None,None,None,,None,"['Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA,IM 916625,IL,41.0,F,"Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followed, observed by hospital staff for approximately 45mins then taken to ER, discharged with 90mins. Body aches and chills for 1-2days. dizziness, nausea, lightheaded for 4-5 days to follow.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,"Omeprazole, Loratidine, Azelastine nasal spray",,"GERD, seasonal allergies",,"pomegrante, Avalox","['Chills', 'Dizziness', 'Nausea', 'Pain', 'Tachycardia', 'Tremor']",1,PFIZER\BIONTECH,IM 916626,NJ,63.0,F,Redness and itching to hands and forearms. also itching to head and behind ears. Took Benadryl 50mg. and applied hydrocortisone cream to affected areas. Continued treatment s needed.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,WRK,Augmentin 875mg ; for dog bite Medrol dose pack day2 ; back; nerve pain multi vitamins,none,,,none,"['Erythema', 'Pruritus']",1,MODERNA,IM 916627,NC,49.0,F,"Redness/induration at injection site, silver color coin size; hardness/swelling/tenderness at injection site- baseball size; itching at injection site and left calf, muscle soreness left leg, left arm; parasthesia left arm and leg",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,"Wellbutrin, Cymbalta, Levothyroxine","Constipation, indigestion, not on day of vaccine",Depression,,"Blue Star Ointment (topical ointment), latex","['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Myalgia']",UNK,MODERNA,IM 916628,MD,33.0,F,"Arm soreness, bodyaches, slight temp, cough.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PUB,Buspirone 5mg 1 tab BID Omeprazole 25mg 1 tab QD,None,None,,None,"['Cough', 'Limb discomfort', 'Pain', 'SARS-CoV-2 test positive']",1,MODERNA,IM 916629,NC,61.0,M,"Headache, chills, muscle aches and weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,"Clonazepam, norvasc,lisinopril, allopurinol,finestaride, paxil",None,"Obesity, htn, gout,anxiety",,Pcn,"['Asthenia', 'Chills', 'Headache', 'Myalgia']",1,MODERNA,IM 916630,ME,56.0,F,"(Typical soreness at injection site for several days after injection.) Surprisingly, 10 days later, red and swollen at injection site - this is what I'm reporting.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,11/25/2020,12/31/2020,36.0,WRK,50 mg daily antibiotic,none,none,,none,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 916631,NY,25.0,F,Arm pain throughout the day that worsened (couldn?t lift up arm past 45 degrees) and at night I had muscle aches all over my body. I felt cold and feverish though did not have a fever. Took 1 g of Tylenol which helped chills and muscle aches. This morning (next day) I am still having muscle soreness so I will probably take another 1 g of Tylenol.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,,,,,Azithromycin,"['Chills', 'Feeling cold', 'Feeling hot', 'Myalgia', 'Pain', 'Pain in extremity']",1,MODERNA,IM 916632,,0.08,M,"Baby had regular 6 week wellness check-up and received all reccomended vaccinations for 6 week old baby. Straight after vaccination baby went to sleep, he then woke up 1 hour after with a screaming cry as if something was terribly wrong, he then started vomiting uncontrollably (like a water fountain) and was in and out of consciousness, very lethargic, breathing started to reduce drastically, baby was floppy. Baby was handed to paramedics and rushed to emergency. After event of vaccine reaction, doctors encouraged to continue with vaccinations, baby was continuously in and out of hospital, suffered from stomach problems/pain as a todler and would notice todler seeking anything cold, usually resulting to lying down on stomach on the cold floor because stomach was always burning hot. He would vomit regularly, suffer from regular nose bleeds for no apparent reason, behavioural/anger issues were displayed, headaches, asthma, and dry skin.",Not Reported,,Yes,Yes,,Not Reported,Y,07/01/1994,07/01/1994,0.0,PVT,N/a,N/a,,,N/a,"['Abdominal pain upper', 'Abnormal behaviour', 'Adverse reaction', 'Anger', 'Asthma', 'Consciousness fluctuating', 'Crying', 'Dry skin', 'Epistaxis', 'Headache', 'Hypotonia', 'Lethargy', 'Respiratory rate decreased', 'Screaming', 'Skin warm', 'Vomiting']",UNK,UNKNOWN MANUFACTURER,SYR 916633,ME,57.0,F,"Sore arm, headache, stuffy nose",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,,,,,"Shellfish, amoxicillin, Percocet","['Headache', 'Limb discomfort', 'Nasal congestion']",1,MODERNA,IM 916634,NC,27.0,M,"Approximately 12 hours of nausea, vomiting, lower back pain, headache, and cold sweats. Rest, fluids, and advil took care of symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None.,None,None,,Penicillin,"['Back pain', 'Cold sweat', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 916635,MA,22.0,F,My arm was sore for about a day. It was also slightly swollen where I got the shot.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,WRK,none,none,no,I've gotten similar arm pain/soreness from other vaccines I've gotten in the past.,none,"['Injection site swelling', 'Limb discomfort']",1,MODERNA,SYR 916636,MI,49.0,F,"12/26-Had the vaccine, 27th evening felt nauseated, woke up in the middle of the night with head tightness(headache), rigors, hot flashes.28th feeling off and fatigued, continued to feel better as the days went on and on the 31st had diarrhea, rigors, temp of 99.3F, hot flashes, muscle aches now.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/27/2020,1.0,PVT,none,,,,,"['Chills', 'Diarrhoea', 'Fatigue', 'Feeling abnormal', 'Headache', 'Hot flush', 'Myalgia', 'Nausea', 'Tension headache']",1,PFIZER\BIONTECH,IM 916637,CT,32.0,F,"At 1:30am I woke up with rigors, temp of 101. Took some Tylenol and was able to fall back asleep. At 7:30am I woke up with rigors again, temp 100.1. Took Tylenol. Also have a terrible headache, pain 7/10, and fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,Adderall Tri nessa birth control,None,None,,NKDA or food allergies,"['Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Pain']",1,MODERNA,IM 916638,FL,41.0,M,"I have metal in my right shoulder, whole right arm went numb for half a day and was week. Metal in my left foot, whole left let=g is swollen and hurts, saw 3 doctors and they didn't know what to do, one doctor gave me Ibuprofen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,"duloxetine, cetirizine, clonazepam",,depression,,,"['Hypoaesthesia', 'Pain in extremity', 'Peripheral swelling', 'Ultrasound scan']",2,PFIZER\BIONTECH, 916639,FL,46.0,F,"Felt flushed and arm swelled up at injection site to size of a gold ball. Hospital staff supervising required ingestion of 25 mg Benadryl immediately upon reaction. Was monitored for 40 min and sent home from work. Within a few hours began to feel body aches and headache. Over the next few hours developed low grade fever 99.6. Pain at the injection site , which I was expecting. I called employee health and reported my symptoms. Was instructed to take ibuprofen or Tylenol for symptom management, to hydrate and rest. Took 600mg ibuprofen. That evening, the same symptoms became worse and I became very weak and nauseous. Also my heart rate became elevated . I usually sit in the 50-60s as I?m an avid exerciser. My HR remained in the 90s- low 100s over the next 48 hrs . The following day (day 2) I had all the same symptoms despite taking 600 mg ibuprofen around the clock. Continued to notify employee health as instructed. Day 3, I had to return to work, temp (with 600 mg ibuprofen on board) was 99.2. I was still achy and headache and weak but less than the previous days. Notified employee health again & was instructed to get a covid test the following day if symptoms didn?t subside. Day 4 , the symptoms mostly passed. No fever . No body aches. No more heart racing only very slight nausea . Very slight headache. Energy mostly returned. Pain at injection site replaced by itching and bruise at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Probiotic,None,None,Tetanus,Latex (angioedema) Cipro (angioedema) Erythromycin (hives),"['Flushing', 'Peripheral swelling']",1,MODERNA,IM 916640,MA,46.0,F,"Severe muscle reaction, entire deltoid involved. Inability to use left arm, any muscle movement causes severe extreme pain. Left limb must be assisted by unaffected arm to avoid any left deltoid activation. Complete loss to range of motion. Soar at rest, as expected with any vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PVT,,none,none,,none,"['Arthralgia', 'Injected limb mobility decreased', 'Joint range of motion decreased', 'Pain']",1,MODERNA,IM 916642,MI,42.0,F,"Approx 8 hours after vaccine, arm pain increased followed by chills, body aches, fever (over 101), nausea, and headaches. Symptoms lasted approx 20 hours, with use of tylenol and ibprof.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,None,Covid Positive Mid November,None,,Penicillin Vancomyocin,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 916643,MA,28.0,F,"Sudden onsite 6pm the next day of fever, chills, sweats, headache, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Norethidrone, Celexa",none,"endometriosis, anxiety, epilepsy",,"seasonal, pets","['Chills', 'Headache', 'Hyperhidrosis', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 916644,OK,58.0,M,Ipsilateral lips numbness and tingling,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,"Amlodipine 5mg; Crestor 20mg, Amitiza 24mg; Baby Aspirin 81mg, Benadryl, Nyquil",None,"Ascending Aorta Aneurysm, hyperlipidemia, hypertension",,None,"['Hypoaesthesia oral', 'Paraesthesia oral']",1,MODERNA,IM 916645,AR,60.0,F,"Starting on day 3 after vaccination, developed a burning feeling near tip of tongue, as if I?d burned it with hot coffee. Area of tongue affected increased each day until today entire tongue is burning. Fissures are present, but no white coating. Today, two separate small blisters are present on lateral edge of tongue near tip.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/29/2020,3.0,PVT,Atorvastatin Aspirin,,,,,"['Plicated tongue', 'Tongue blistering', 'Tongue discomfort']",1,MODERNA,IM 916646,ID,37.0,F,"chills beginning @ 2030 on 12/30/2020 & lasting til the am @ 0500, 0500 on 12/31/2020, hypotension causing dizziness 0800: flank pain, right temporal headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,paraguard iud,,no,Flu 2016-age 33,nka,"['Chills', 'Dizziness', 'Flank pain', 'Headache', 'Hypotension']",1,MODERNA,IM 916647,PA,42.0,M,I had general sides effects. Chills nausea vomiting muscle joint pain. With in 6 hours after the vaccine lasting approx 6 hours or so.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,Metformin,,Diabetes II,,,"['Arthralgia', 'Chills', 'General symptom', 'Myalgia', 'Nausea', 'Vomiting']",UNK,MODERNA, 916648,IN,47.0,F,Severe rash with hive type welts on top of the rash. Extremely itchy. It appeared as a rash with welts covering the right side of rib cage and has progressed to covering scalp to ankles.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/21/2020,3.0,UNK,Levothyroxine Phentermine Lithium Abilify Lamictal,"Covid 19, date of symptom onset 11/28/2020",Asthma,,None,"['Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,SYR 916649,FL,46.0,F,"On 12/31: vaccine at 1:05 pm; arm soreness and fatigue starting around 3 pm. On 1/1/21: nausea and chills at 1 am, severe headache and light sensitivity at 7 am. (now 8:30 am)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,Vitamins and probiotics,None,Arthritis,,"Morphine Mild allergies to pine, ragweed, cats, some foods","['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain in extremity', 'Photophobia']",1,MODERNA,IM 916650,MA,28.0,F,"employee c/o shakiness, rapid heart rate, headache and itching after receiving Moderna Covid-19 vaccine. Evaluated by EMS on site. benadryl 25mg administered PO at 14:15pm. family member was contacted and arrived to drive employee home to monitor",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,12/27/2020,0.0,WRK,"omeprazole, loratadine, tegretol, citalopram, topamax",was on Amoxicillin for tooth abscess (last dose 1 week ago),"seasonal allergies, acid reflux, migraines, anxiety, depression","adverse reaction to flu vaccine (fever, rash, hives)","bananas, pineapple, metals","['Headache', 'Heart rate increased', 'Pruritus', 'Tremor']",1,MODERNA,IM 916651,PA,53.0,F,"Burning sensation in chest within 5 ministers of receiving immunization. Continued for 4 hours. 3 hours into symptoms, treated with Zyrtec and proposed. Symptoms resolved 1 hour after treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Acyclovir, Prilosec.maxide, potassium chloride, magnesium",None,"Obesity, high blood pressure",,"Azithromycin, Benadryl",['Burning sensation'],1,MODERNA,IM 916652,NC,29.0,F,"Immediate tingling to face, then on 12/23 migraines and smell adversions, 12/24 chills body aches and skin burned, 12/25 no taste or smell with chills body aches diarrhea skin burned and brain fog, 12/26 positive rapid covid test and symptoms continue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/25/2020,3.0,PVT,"Zyrtec, Wellbutrin",None,None,,None,"['Anosmia', 'Chills', 'Diarrhoea', 'Migraine', 'Pain', 'Paraesthesia', 'Parosmia', 'Skin burning sensation', 'Taste disorder']",1,PFIZER\BIONTECH,IM 916653,AZ,49.0,F,Anaphylaxis- needed 3 doses of epinephrine before admission to ER. In ER received IV steroid and famotidine. Was given prescriptions for epipen and oral steroids (60mg x 5 days).,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None,None,Multiple Sclerosis Asthma,,Copaxone CT contrast,['Anaphylactic reaction'],1,PFIZER\BIONTECH,IM 916654,MN,38.0,F,"25 minutes after the vaccine was given, I felt a rush of cold go down my left arm and had a cold sensation and then tingling/numbness to my left wrist and left hand for about 36 hours until it gradually subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Ibuprofen, prenatal vitamin",Sore throat one week prior to vaccination,Low back pain Varicose veins,,Compazine,"['Feeling cold', 'Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 916655,CT,47.0,F,"Ever since I got the vaccine I have headaches which increased to near migraine level on 12/29, then yesterday 12/31 at 330pm while painting my left face became paralyzed and numb. Went to ER Had CT/CTA of head EKG, chest Xray and multiple labs including Lyme test which will not be resulted for 5-7 days. ER started me on taper prednisone and doxycycline. Diagnose with significant Bell's Palsy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/31/2020,14.0,WRK,"Zoloft, ambien",none,none,,penicillin,"['Chest X-ray normal', 'Computerised tomogram normal', 'Electrocardiogram normal', 'Facial paralysis', 'Headache', 'Hypoaesthesia']",1,PFIZER\BIONTECH,IM 916656,TN,47.0,F,"Extreme and worsening right upper hip pain, spreading to center lower back. Making it extremely difficult to take full breath. Unable to bend, sit up. Extreme pain while laying in any position and needing help to stand. Pain lvl 9.5",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,Amlodipine,,Hypertension Asthma Arthritis,Flu like symptoms from flu shot. pain lvl 6 to 7,,"['Arthralgia', 'Back pain', 'Dyspnoea']",3,PFIZER\BIONTECH,IM 916657,CT,33.0,F,"Received Moderna vaccine in left deltoid on 12/24/2020. Originally had injection site soreness lasting ~2-3 days which then 100% resolved. On 12/29/2020, developed tender, sore, left axillary lymph node. On 1/1/2020, woke with tenderness, soreness, erythema, warmth and induration localized to injection site on left deltoid.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/29/2020,5.0,PVT,Labetalol 100mg BID Prenatal Vitamins Nasocort Xyzal,None,Hypertension,,Erythromycin - behavioral as a child,"['Axillary pain', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site warmth', 'Lymphadenopathy']",1,MODERNA,IM 916658,NH,66.0,F,"I have nerve pain in the back of my left ear that has grown to encompass a larger area below my ear and up my skull about 2 inches. Also moving down my neck under my ear, feels like it is getting numb. It feels more like numbness is occurring hourly and the pain seems to be creeping into my ear drum. Scale of maybe 5 from a 1 to 10 scale of pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,OTH,"Magnesium, Vitamin D3, sodium alginate, rhizinate, iodine supplement",none,"hemochromatosis, high cystolic blood pressure, herniated disc L5/S1",,"Lactose intolerant, allergic to codeine, skin sensitivity to talc","['Ear pain', 'Hypoaesthesia', 'Neck pain', 'Neuralgia']",UNK,MODERNA, 916659,VA,49.0,F,Cellulitis below the injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PVT,None,None,None,,None,['Injection site cellulitis'],1,MODERNA,IM 916660,ME,61.0,F,"Body ache, head ache, fever, nausea, liwer leg muscle spams/cramping",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,"Fiber, pro biotic, vitamin c, vitamin d, modere: trim, burn, biocell and antioxidant, Tylenol.",None,None,,Penicillin,"['Headache', 'Muscle spasms', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 916661,FL,59.0,F,"headache, chills, right pain .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,OTH,,,,,,"['Chills', 'Headache', 'Pain']",1,MODERNA,JET 916662,MO,57.0,F,"severemuscle pain, high fever (101.3 F), vomiting,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,SEN,"propanolol, lisinopril, cymbalta, trazadone, fenofibrin, levothyroxine",covid 19,"hypertension, mitral valve prolapse, hyperlipidemia, hypothyroidism, asthma",,"augmentin, statins","['Myalgia', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 916663,CO,39.0,F,Moderate arm soreness/stiffness for 24-36 hrs followed by axillary lymphadenopathy for a week+.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/25/2020,2.0,WRK,"Metoprolol, aspirin 81 mg",None,History of internal carotid and vertebral artery dissections,,None,"['Lymphadenopathy', 'Musculoskeletal stiffness', 'Pain in extremity']",1,MODERNA,IM 916664,NY,60.0,F,Headache-persistent Weakness x 48 hours Fatigue x48 hours Body aches x48 hours Arm pain swelling and redness persistent,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,None,None,None,,Nuts Reglan,"['Asthenia', 'Erythema', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 916665,KS,45.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,OTH,D3 5000iu Zyrtec d Rosuvatatin Metformin Monteukast,,,,Trees Dust Mites Mold Latex,['No adverse event'],UNK,MODERNA, 916666,NY,26.0,F,"injection site pain, tenderness, redness, swelling- hot to the touch. started within 3 hours. Applied ice. Headache- starting 4 hours after the vaccine. relief with tylenol but reappeared after 3-4 hours. muscle aches/fatigue- about 6 hours after the vaccine. night of the vaccine- muscle aches, fatigue, headache- took tylenol Wednesday-morning of day after vaccine- terrible headache, arm swelling redness and hot to touch, could not lift or touch arm. Extreme fatigue, could not keep my eyes open. Wednesday night-fever- started around 4pm tmax 101.0- fevers continued through the night with headache, chills and lower back pain. Extreme fatigue- went to bed around 8pm and woke up at 12pm thursday. Thursday morning- fatigue, increase in swelling and arm tenderness- injection site continued to be very hot to the touch and painful/red. Applied ice to site. Had a low grade fever 100.6 for a few hours. Tylenol taken ATC. Thursday night- no fever, headaches or fatigue but injection site cont'd to be red hot and swollen- cellutlits looking saw my PCP (wednesday prior to fever) who agreed it was a localized reaction with adverse events. Discussed with my physician at work on thursday night who stated it was a cellulitic localized reaction. fri morning- injection site improving- remains swollen, slightly itchy. less red and less warm to the touch. Beginning to form a bruise.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,birth control (generess Fe) xyzal singulair,none,none,,levaquin mold spores cat/dog pollen birch trees horses strawberries,"['Back pain', 'Fatigue', 'Headache', 'Injected limb mobility decreased', 'Injection site bruising', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Local reaction', 'Myalgia', 'Pyrexia', 'Somnolence']",1,MODERNA,IM 916667,FL,41.0,M,"I work at a Hospital sterilizing surgical equipment. After I received the vaccine, the hospital staff observed me for 15 minutes to see if a reaction occurred. I felt fine, and they told me I could go. I was working that day (2-10:30pm) and had gotten vaccinated at the beginning of my shift. The rest of my shift went fine. Near the end, though, my arm began to feel sore. Driving home, I began to feel tired. By the time I got home, it felt like a cold was setting in. I ate a large bowl of chicken soup to try to feel better. I stayed up a little bit, but was feeling woozy by this point and went to bed. Bad chills set in and I began to shake I felt so cold. I used a heating pad to help with this. I tried to sleep, but my head was throbbing. The next morning, I tried to sit up in bed but my first attempt proved too difficult. I took it slower. I was able to sit up eventually. Standing was also difficult. I spent the day mostly lounging on the couch. I slept a little better that night, but my head was still throbbing somewhat. No chills this time. Getting up the next morning went a little better. I was able to sit up in bed without issue and walking around did not prove as much of a chore.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None,None,None,,None,"['Chills', 'Dizziness', 'Dysstasia', 'Fatigue', 'Headache', 'Nasopharyngitis', 'Pain in extremity', 'Tremor']",1,MODERNA,IM 916668,PA,37.0,F,"TIA symptoms - difficulty speaking, reports leaning towards the left side and was dizzy for about 10min.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/27/2020,4.0,PVT,"cholecalciferol 400U daily, cyanocobalamin 500mcg daily, ethinyl estradiol-norgestimate, multivitamin",,"anemia, GERD, IBS",,NKA,"['Computerised tomogram normal', 'Dizziness', 'Magnetic resonance imaging brain normal', 'Posture abnormal', 'Speech disorder', 'Transient ischaemic attack']",1,PFIZER\BIONTECH,IM 916669,NE,58.0,F,"Chills, fever and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,PVT,Advil,none,none,,none,"['Chills', 'Headache', 'Pyrexia']",1,MODERNA, 916670,UT,20.0,F,"Repeated shaking with chills, headache, nausea and vomiting, muscle/joint aches, fatigue, fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,"Nexplanon, Mirena iud, pantoprazole, cymbalta, multi vitamin, spirnolactone, furosemide, phentermine, buspar, and hydroxyzine",Covid positive 12/6,"Endometriosis, interstitial cystitis, depression, anxiety, gastritis, and migraines",Tdap,Kiwi,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 916671,VA,56.0,F,"Body aches, chills fever lethargy",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,None,,Arthritis,,Sulfa penicillin,"['Chills', 'Lethargy', 'Pain', 'Pyrexia']",1,MODERNA,IM 916672,CT,39.0,F,"All at injection site area: pain, swelling, hardness, red and very warm to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,"Flintstone multivitamin, levothyroxine, pepcid, pantropazole, phetermine, b12, vitamin D2, biotin, calcium",Sinus infection 1 month prior.,Back pain,,Sulfa Augmentin,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 916674,NY,61.0,M,"Fever, Chills, Nausea, body pains. all started 12 hours after the shot. Got better and went away the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,none,none,none,,penicillin,"['Chills', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,SYR 916675,AZ,33.0,F,I had a small burning sensation after the initial injection near the injection site. Felt fine for the rest of the morning and afternoon. In the evening I started to feel feverish. It was at 99.5. When I woke up this morning my fever had progressed to 101.8. I do have soreness near the injection site as well.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,"Omega 3, vitamin D, vitamin B Complex, women?s multivitamin",None,None,,Amoxicillin,"['Injection site pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 916676,CT,51.0,F,Nausea for a small while. Terrible headache the day after. Advil relieved it slightly. A little fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,morphine cephalosporins,"['Fatigue', 'Headache', 'Nausea']",1,MODERNA,IM 916677,MA,35.0,F,"Pins and needles in face started 12/29 ER visit, physical exam. Intermittent pins and needles continue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/29/2020,5.0,OTH,,,?antiphospholipid syndrome 2018,,NKDA,['Paraesthesia'],1,MODERNA,IM 916678,DE,39.0,M,"Fever, sneezing, body aches, diarrhea, blister at the site of vaccine administration, runny nose, slight dizziness, sore throat with occasional cough.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/31/2020,2.0,SEN,none,none,none,,none,"['Cough', 'Diarrhoea', 'Dizziness', 'Injection site vesicles', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'Rhinorrhoea', 'Sneezing']",1,PFIZER\BIONTECH,IM 916679,MO,22.0,F,"Reported feeling shaky and a racing heartbeat. Per the ED physician's notes, by the time patient was evaluated in the ED, her symptoms had resolved and she was released from care with no additional follow-up necessary.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,None,None Known,None Known,,None known,"['Electrocardiogram abnormal', 'Palpitations', 'Sinus tachycardia', 'Tremor']",1,PFIZER\BIONTECH,IM 916680,NY,52.0,M,"Fever, Chills, Body aches, fatigue, shortness of breath, coughing",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,Atorvastatin Triamterene HCTZ Prilosec Antibiotic,,High Blood Pressure High Colesterol,,No,"['Chills', 'Cough', 'Dyspnoea', 'Fatigue', 'Pain', 'Pyrexia']",1,MODERNA,IM 916681,,33.0,F,"Post vaccination day 8 developed three small raised red, hot rashes near vaccination site. Patient circled the rashes on day 8, upon awakening on day 9 patient noticed rash has spread but was not as raised. Rash does not itch but is hot to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/31/2020,8.0,PVT,duloxetine 60 mg daily acyclovir 400 mg po bid cetirizine 10 mg daily maca root 2 capsules daily tri-sprintec one tablet daily,,,,Macrobid- difficulty breathing ceclor (as a baby-unknown reaction),"['Injection site erythema', 'Vaccination site rash', 'Vaccination site swelling', 'Vaccination site warmth']",1,MODERNA,IM 916682,NY,63.0,F,"fever to 102F, chills, sweats, severe bodyaches, cough and diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,,,,,,"['Chills', 'Cough', 'Diarrhoea', 'Hyperhidrosis', 'Pain', 'Pyrexia']",2,MODERNA,IM 916683,MN,40.0,F,"Soreness at injection site, headache, fatigue, body aches, diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,B12 monthly injection Probiotics,,Crohn's Disease,,NKA,"['Diarrhoea', 'Fatigue', 'Headache', 'Injection site pain', 'Pain']",1,MODERNA,IM 916685,NC,36.0,M,"Few minutes after receiving injection developed lightheadedness/dizziness, nausea, palpitations, generalized tingling sensation, clamminess. Upon checking vitals was tachycardic with heart rate in 120s; drop in blood pressure to 100/50 (my baseline is 120/75). No wheezing. No stridor. Oxygen saturations 99%. No hives or rash. No facial or peripheral swelling. Provided fluids (by mouth), cold compresses, and benadryl. Gradual improvement after this. Majority of symptoms lasted for approx 1 to 1.5 hours; with some waxing/waning palpitations for another~1 hour. I have no prior history of similar symptoms after receiving vaccines or medications in the past.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,none,none,none,,none that I am aware of,"['Blood pressure decreased', 'Cold sweat', 'Dizziness', 'Nausea', 'Palpitations', 'Paraesthesia', 'Tachycardia']",1,PFIZER\BIONTECH,IM 916686,IN,25.0,F,"Fevers as high as 100.8 starting at around 0200 (about 12hours after vaccine administration). Advil taken, fever broke",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,"Wellbutrin 150mg, cyclobenzaprine 5mg",,Depression,,Artichokes,['Pyrexia'],UNK,MODERNA,IM 916687,WA,56.0,M,"Swollen lymph nodes, chills, body aches, sore injection site No treatment, symptoms lasted over night",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PVT,"Baby aspirin, Crestor 20 mg",None,None,,None,"['Chills', 'Injection site pain', 'Lymphadenopathy', 'Pain']",1,MODERNA,IM 916688,NY,37.0,F,7 hours later felt faint 16 hours after injection had mild headache Day after injection had nausea for most of the day and sporadic twinges of dull aches in random joints.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,Syeda,,,,,"['Arthralgia', 'Dizziness', 'Headache', 'Nausea']",1,MODERNA,IM 916689,TN,69.0,M,"Soreness at injection site, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,None,Cardiac stent 10/2020 PVCs,Coronary artery disease,,Bee stings,"['Fatigue', 'Injection site pain']",1,MODERNA,IM 916690,CA,37.0,M,"Typical sore arm similar to flu shot. Following day, had minor low half body aches and chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PUB,,,,,Amoxicillin,"['Chills', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 916691,NY,58.0,F,"Dizzy, Nauseous, Pain at site of injection, Headache, chills. A phlegmy cough developed in about 9 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Keppra, Lamictal",Seizure disorder,Seizure disorder,,None,"['Chills', 'Dizziness', 'Headache', 'Injection site pain', 'Nausea', 'Productive cough']",1,MODERNA,SYR 916692,TN,28.0,F,"From 0-24 hours post injection, I had soreness at injection site. At 18 hours post injection, I had abnormal back pain (lasted about 30 minutes). At 29 hours post injection, I had rapid onset chills (lasted 3 hours) and fever (highest measurable was 100.3, lasted about 1 hour), feeling faint (15 minutes), nausea (15 minutes).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,Spironolactone 50mg,COVID-19 detected result on 12/18/2020,Polycystic ovarian syndrome,,None,"['Back pain', 'Chills', 'Dizziness', 'Injection site pain', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,IM 916693,WA,25.0,F,Whole body aches and lethargy that started approximately 3 am on 1/1/21. Severe injection site pain starting approximately 9 pm on 12/31/20.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PHM,Diphenhydramine,None,Narcolepsy,,Nkda,"['Injection site pain', 'Lethargy', 'Pain']",1,MODERNA,IM 916694,CA,42.0,F,"I had sudden onset itching and tenderness, swelling, redness about 8 days after receiving the Pfizer vaccine, about an inch below the injection site in a wide band across my outer upper arm. It was bad enough that cellulitis briefly crossed my mind bc the redness and tenderness continued spreading for about 24 hrs. It started resolving on post vaccine day 11, but I?m still having mild itching and redness on post vaccine day 12.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/28/2020,8.0,WRK,Vitamin D,None,None,,"Lactose, neosporin, nickel","['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Pruritus']",1,PFIZER\BIONTECH,IM 916695,,34.0,F,"Headache, chills, joint pain, fatigue and fever starting approximately 20 hours after vaccination and resolved 30 hours after vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,UNK,,COVID + on 12/11/2020,,,NKA,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Pyrexia']",1,MODERNA,IM 916696,MI,20.0,F,"Patient received first dose of moderna covid-19 vaccine EUA. She is an employee of the nursing home. While waiting for 15 minutes, patient fainted and fell. She became alert immediately after. Patient reports no allergies or chronic medical conditions. No epipen or Benadryl were administered. Her vitals were taken immediately after: bp 128/80, temp98.0, Osat 99%, HR 88. Patient also reports not remembering if she has anything to eat that day .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,Unknown,No long term health problems reported on consent form,None reported on consent form,,None according to consent form she filled out,"['Fall', 'Syncope']",1,MODERNA,IM 916697,NC,59.0,F,"nausea, vomiting, headache, fatigue, chills, low-grade fever, pain at the injection site and the whole arm, joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,None,None,allergies,,None,"['Arthralgia', 'Chills', 'Fatigue', 'Feeling cold', 'Headache', 'Injection site pain', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Vomiting']",UNK,MODERNA,SYR 916698,NV,41.0,F,"Extreme shoulder pain with any movement. Inability to lift are overhead. Treated with lidocaine patch, anti inflammatories, Tylenol with codeine. Minor symptom relief.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,"Wellbutrin XL, vitamin D, vitamin B-12",None,None,,None,"['Arthralgia', 'Mobility decreased', 'Pain']",1,MODERNA,IM 916699,FL,25.0,F,"Stabbing ear pain in one ear. I'm not sure if it's related to the vaccine or if I'm just developing an ear infection, but it started a few hours after I received the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/01/2021,1.0,PVT,,,,,,['Ear pain'],1,MODERNA,IM 916700,NY,42.0,F,"Fatigue, mild muscle aches, mild nausea, tiredness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Multi Vitamin, biotin, probiotic",,,,"Claritin, morphine, lexapro","['Fatigue', 'Myalgia', 'Nausea']",1,MODERNA,IM 916701,MA,64.0,F,"Patient reported of itching in the left arm approximately 30 minutes after receiving COVID vaccine. No shortness of breath, hives or redness was noted. Vitals were taken with normal results; client waited for 15 minutes reporting itching subsiding. Vitals reported at 1219: pulse 91 bpm, temp 98.1 degrees Fahrenheit, blood pressure 162/84 (reported normal for client), and oxygen 100% on room air.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"ALLEGRA-D 12 HOUR 60-120 mg per tablet fluticasone (FLONASE) 50 mcg/actuation nasal spray furosemide (LASIX) 20 MG tablet gabapentin (NEURONTIN) 100 MG capsule ibuprofen (ADVIL,MOTRIN) 800 MG tablet losartan-hydrochlorothiazide (HYZAAR) 50-",,,,Penicillin,['Pruritus'],1,MODERNA,IM 916703,TX,60.0,F,Posterior vitreous detachment,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/30/2020,8.0,OTH,,None,Mild depression,,None,"['Ophthalmological examination', 'Vitreous detachment']",1,MODERNA,IM 916704,TX,35.0,F,"Moderna COVID?19 Vaccine EUA Arm severe pain, redness, hard hives that keep worsening. Fever Chills Body aches Headache Nausea and vomiting Tachycardia with hypertension Dizzy Sweats I felt worst after vaxx than I ever did with COVID.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,Zoloft Hydrochlorothiazide IUD,None,"Postpartum depression - being treated Heart issues from pregnancy, hypertension - being treated",,Compazine Reglan Monocryl Stitches,"['Chills', 'Dizziness', 'Erythema', 'Headache', 'Hyperhidrosis', 'Hypertension', 'Induration', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'Tachycardia', 'Urticaria', 'Vomiting']",1,MODERNA,IM 916706,AL,41.0,M,"The next afternoon on 12/30/20 I experienced a slight pain like someone scratched me on my chest, stomach, and back. The next morning (12/31/20) the pain turned into burning sensation like a mild sunburn all over my chest, stomach, and back areas. I am still experiencing the burning sensation today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,12 hour Mucinex Ibuprofen cough medicine,Sinus Cold,None,,None,"['Burning sensation', 'Pain']",1,MODERNA,SYR 916707,CT,51.0,M,"101.3 fever on and off overnight, chills, severe body aches, headache, injection site pain and swelling along with lymph node swelling left armpit. At 24 hrs no treatment, clinic closed for New Year?s Day. Intake of extra water, bananas for dehydration and acetaminophen for fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,None,None,None,,Penicillin,"['Chills', 'Dehydration', 'Headache', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy', 'Pain', 'Pyrexia']",1,MODERNA,IM 916708,VA,37.0,F,"Right arm became very tender, then by the morning I had muscle/joint pain in my upper body. I felt very tired, but my blood pressure was 97/46 about three hours after the injection and this could have been related more to my iron anemia which gets treated with transfusions. The pain in my upper body lasted about 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Lamictal, remeron, saxenda",Iron deficiency,Bi polar,,Erythromycin,"['Arthralgia', 'Blood pressure decreased', 'Fatigue', 'Iron deficiency anaemia', 'Myalgia', 'Pain in extremity']",1,MODERNA,SYR 916709,MN,37.0,F,"Large bull eye bruise with ring of purple around injection site. Warmth and firmness at site, itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Birth control, effexor, trazadone",none,none,,Topical allergy to metals,"['Injection site bruising', 'Injection site discolouration', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 916710,MO,23.0,F,"Acute appendicitis, onset morning of 1/1/2021 (Reporting this because Pfizer covid vaccine had 3-4x higher risk of appendicitis, although data not reported for Moderna covid vaccine)",Not Reported,,Yes,Yes,,Not Reported,U,12/29/2020,01/01/2021,3.0,PVT,Synthroid,,Hypothyroidism,,NKDA,"['Appendicitis', 'Band neutrophil percentage increased', 'Surgery', 'White blood cell count increased']",1,MODERNA,IM 916711,NY,44.0,F,"After 12 hours of receiving the vaccination, my legs felt heavy. The bottom of my right foot felt numb after standing for a little time. The feeling of heaviness continued, but I was able to walk and completed my daily activities. My right arm felt painful similar to receiving a tetanus shot, I took some Tylenol and drank some coffee and felt better. However, the feeling of heaviness in my legs continued. On Sunday, my left leg continued to swell and I noticed that the area under my knee cap and above the upper part of the rim of my socks was visible swollen, red, and painful. I took some Motrin and the swelling improved. Later, I noticed I am having musculoskeletal pain and general body aches that improve with Mortin but returns. I am able to continue with my ADLs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,"Multivitamin, Vit D, and Iron supplements.",none,"Pelvic Congestion Syndrome, and Varicose veins",,Allergic to Cipro and dust.,"['Erythema', 'Hypoaesthesia', 'Limb discomfort', 'Musculoskeletal pain', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Ultrasound Doppler normal']",1,PFIZER\BIONTECH, 916712,OH,50.0,F,"2 days of intense migraines, several areas on left arm with redness, pain and swelling that seems to be spreading",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,None,Covid,None,,Gluten,"['Erythema', 'Migraine', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,SYR 916713,CO,57.0,F,"I am a support healthcare worked at a physician's off ice. Therefore, I qualified for the Covid vaccine. At 10:15 am on Thursday 12/31/2020 I received the Pfizer Covid 19 vaccine in my left arm at Hospital. After receiving the vaccine, I went to a 15 minute observation area. At approximately 10:20-10:25, I started to get hives on the left side of my neck below the jaw line. When the nurse circulated by to ask how I was feeling, I reported the start of hives and showed her the location. She asked if I frequently get hives and I said yes. She asked if I had any Benedryl with me. I said I did. She directed me to take 1 - 25 mg tablet and advised would call a physician, who arrived soon after. She observed the hives, asked several questions and then I was taken to ER by wheelchair. I was evaluated by PA, given an IV of steriod, prednisone, and montitored for until 12:20 PM, then was discharged.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Losartan 50 mg, Vitamin D, FIsh Oil, ibuprophen",None,Hypertension diagnosed July 2020 Sleep apnea diagnosed Feb 2010,Mild reaction to Tdap Feb 2017,"Meds: penicillin, amoxicillin, clindamycin Foods: none known Environmental: grasses, weeds, pine trees, pollen, mold, cats",['Urticaria'],1,PFIZER\BIONTECH,IM 916714,CA,40.0,F,"No adverse event, just side effects: Sore arm on day 1, within 24 hours low grade fever 100.2F, aches, neck lymph node soreness/slight swelling, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,None,None,None,,NKA,"['Fatigue', 'Lymph node pain', 'Lymphadenopathy', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 916716,TX,69.0,F,Very mild symptoms. Lethargic and pain at injection site. Completely back to ?old? self in 24 hours. Would I take it again? ABSOLUTELY!!!! My husband had no pain at injection but very mild lethargy. He just took a nap yesterday...,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Athenolol 50mg Atorvaststin 20 mg Metformin XR 500 mg Curcumin Florastor Vitamins D, B12 Cosamine DS",None,"None My adverse reaction was mild: Soreness at injection site and Tiredness, as if I could tell something slightly unusual was going on. Lasted for 24 hours and then gone. Would I take it again? ABSOLUTELY. THANK YOU SO MUCH FOR WHAT YOU ARE DOING FOR US ALL, CDC.",,"Contact dermatitis: Fragrance, Methythiozine","['Injection site pain', 'Lethargy']",UNK,MODERNA, 916717,MO,43.0,F,"12/24 - 12/27 = soreness and muscle pain mostly. No other symptoms 12/28-29 - Tender... becomes increasingly sore to touch, growing hot and itchy 12/30 - Red bumps/rash emerge around injection site; growing hotter and more itchy 12/31 - Redness and swelling grows, muscle tissue becomes hotter and more hard, about 2"" in diameter 01/01 - Redness and inflamed area is larger now.. 3"" across, 4"" high, with increased heat, pain/soreness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/30/2020,6.0,PVT,,,,,,"['Inflammation', 'Injection site reaction', 'Myalgia', 'Myosclerosis', 'Pain', 'Pruritus', 'Rash erythematous', 'Skin warm', 'Tenderness']",1,MODERNA,SYR 916719,MN,52.0,F,"Fatigue, fever, nausea, joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,SEN,"Magnesium, fish oil, calcium, iron, vitamin c, vitamin b12 complex",None,None,,Morphine,"['Arthralgia', 'Fatigue', 'Nausea', 'Pyrexia']",1,MODERNA,IM 916720,NY,23.0,M,Patient made statements that he was having a harder time swallowing. Blood pressure was taken. We assessed and then he began to report difficultly breathing and a very difficult time swallowing. Blood pressure was taken and lung sounds assessed. EMS was called. Epi pen was given. Within 5 minutes he reported feeling much better and no issues with swallowing or breathing. EMS arrived on site and he was transferred to the local hospital.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,unknown,,"['Dysphagia', 'Dyspnoea']",1,MODERNA,IM 916721,MT,47.0,F,Moderna COVID-19 Vaccine EUA Severe arm soreness at site of injection in the left shoulder with inability to lift the left arm above 90� for 2 days following the injection. Still mildly sore today and not full range of motion resolution. Mild headache and chills for about one hour approximately 6 hours after injection. Global muscle stiffness the evening of the date of injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,UNK,"Armour thyroid , vitamin C, vitamin D, zinc, vitamin B complex, baby aspirin, elderberry, calcium citrate",,"Dysautonomia, thyroid dysfunction, clotting disorders",Muscle soreness at site of vaccinatin,Amoxicillin,"['Chills', 'Headache', 'Injected limb mobility decreased', 'Injection site pain', 'Musculoskeletal stiffness']",UNK,MODERNA, 916722,AL,47.0,F,"16 hours after injection, started having chills, fever 102.2, achy all over, worst headache I ever had, symptoms continue now as of 1/1/21 10:00 am, fever not as high, 99.4-100, aches have improved, headache remains the same, only eases after taking Norco which I had left from a knee surgery years ago.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PUB,"Montekulast 10 mg, Benadryl 25 mg tab, miralax 17 gr, Flonase 50 mcg, Vitakin c 250 mg, vitamin d 2000, Tylenol 500 mg tab, pantaprazole sodium dr 40 mg tab, diclofenec sodium ER 100 mg tab, iron sulfate 325 mg tab, curcumin 500 mg cap, su",None,"GERD, arthritis, neuropathy, tarsal tunnel syndrome",,None,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 916723,TX,39.0,M,"Headache and myalgias started day 2 after vaccine, treated with ibuprofen and APAP turned into: Migraine headache started 8 days after vaccine, lasted 2 days and treated with sumatriptan led into: Shingles on left side of face started after migraine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/27/2020,9.0,UNK,,,,,none,"['Headache', 'Herpes zoster', 'Migraine', 'Myalgia']",1,PFIZER\BIONTECH,IM 916724,NE,56.0,F,"Injection site pain tenderness and swelling. Fatigue, headache, muscle pain, joint pain, chills, fever, night sweats, lethargy. Lasting two days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,Metoprolol ER 50mg once a day Hydrochlorothiazide 25 mg once a day,,Hypertension,,Penicillin,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Lethargy', 'Myalgia', 'Night sweats', 'Pyrexia']",1,MODERNA,SYR 916726,OH,41.0,F,"Very early in the morning on December 31st, I began to have serious itching at the injection site. There was no rash or anything you could see on the skin, it was a very deep itch. In the morning my arm was sore again just like it had been right after the injection the week before. The area began to get swollen and red. Today it is even more swollen and red and warm. It is sore and itchy as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/31/2020,7.0,PVT,"Sertraline, vitamin D, magnesium glycinate and vitamin B2",None,Depression and migraines,,None,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 916727,RI,33.0,F,"Approximately 7 days post vaccine, developed painful left axillary lymphadenopathy. Later that evening, developed nausea, dizziness and urticaria around injection site covering left deltoid area. This is now firm, enlarged, tender and erythematous.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PVT,,None,,,Sulfa,"['Dizziness', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site urticaria', 'Lymphadenopathy', 'Nausea']",1,MODERNA,IM 916728,MA,48.0,F,"Patient received vaccine in Administration clinic. During observation period, patient reported feeling nausea, lightheaded, and tightness in the back of head. Patient also reported vomiting in bathroom. RN remained with patient. Vital signs: 132/84; HR 99; 02 Sat 99%. Patient provided water, refused crackers. Remained with patient for emotional support. Vital signs retaken @ 3:52pm 111/75; HR 75; 02 Sat 100%. Remained with patient in observation room. 4pm patient reported feeling better and symptoms resolving. Vital signs at discharge: 137/77; HR 72; 02 Sat 100%.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None,None,Asthma,,NKA,"['Dizziness', 'Nausea', 'Tension headache', 'Vomiting']",1,MODERNA,IM 916729,CT,27.0,F,"Moderna COVID-19 Vaccine EUA Generalized external itching throughout entire body with no obvious rash involved. Symptom began approximately one day following vaccine administration and have continued until present day, so far now for 5 days. Have not taken any medications thus far but will try Benadryl today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/28/2020,1.0,PVT,Tri femynor,None,None,,Cephalosporins,['Pruritus'],1,MODERNA,IM 916730,MA,46.0,F,Patient received vaccination in Administration Clinic. Post vaccination patient complained of feeling very warm with throat fullness. No other symptoms reported. Patient positioned self by window and felt need to remove mask. Proceed out called. ED team responded and patient evaluated by MD Patient remained in clinic under observation until symptoms resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Metformin Simvastatin Vitamin D3,,,,NKA,"['Feeling hot', 'Throat tightness']",1,MODERNA,IM 916731,FL,39.0,F,"Redness, tenderness, induration, hardness, itchiness on the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,None,None,None,,None,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,IM 916732,OH,32.0,F,"redness, bumps, itchiness, and local swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/01/2021,8.0,PVT,Pre-natal vitamin,none,vitiligo,,none,"['Erythema', 'Pruritus', 'Rash', 'Swelling']",1,MODERNA,IM 916733,MD,30.0,M,- Injection site soreness: developed the day after injection and largely resolved after about 24-36 hours. - Headache: minor tension headache developed about 48 hours after injection and lasted a little over a day. - Sore throat: mild; developed about 48 hours after injection and continues to persist about 2 days later.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,MIL,Lexapro 15mg PO QD Trazodone 75mg PO QHS,none,high cholesterol,,no known allergies,"['Injection site pain', 'Oropharyngeal pain', 'Tension headache']",1,PFIZER\BIONTECH,IM 916734,ME,45.0,F,"Localized redness, swelling, pain, and itching at injection site that started a week after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/31/2020,7.0,PVT,"NP thyroid, multivitamin, fish oil, vitamin c, vitamin d, probiotic",None,Goiter,,Penicillin Wellbutrin,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 916735,NY,62.0,M,"CHILLS, FEVER, HEADACE, NASEA, NO APPITITES AND FATIGUE",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,UNK,LEVOTHYROXINE,HAD COVID 19 ON 11/18/2020,NONE,,PREDNISONE,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia']",UNK,MODERNA,SYR 916736,OH,35.0,F,Pain at injection site x 2.5 days. Body aches x 2.5 days. Headache x 1 day. Possible low grade fever x 2 days. Fatigue x 2.5 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Zyretc, spirolactine, micronor",None,None,,Na,"['Fatigue', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 916738,NY,33.0,F,"Vaccination was received on December 23, 2020. No immediate adverse effects. Starting on December 31, 2020 I developed a localized inflammation at the injection site. Associated puritis and tenderness. Over the last 24 hours erythema has increased. I have not treated with any compresses or over-the-counter medications.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,UNK,None,Mastitis 24 hours prior treated with dicloxacillin,None,,"Shellfish, codeine","['Injection site erythema', 'Injection site inflammation', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,IM 916740,UT,27.0,M,"Fever, muscle aches,chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PUB,None,None,None,,None,"['Chills', 'Myalgia', 'Pyrexia']",UNK,MODERNA, 916741,AR,68.0,F,"on dec 22 I felt some myalgias, chills, fatigue, HA --quite normal. That evening, noted small amount swelling R hand --I iced and took acetaminophen. By Dec 25, hand very swollen and painful with decreased ROM all fingers",Not Reported,,Not Reported,Not Reported,,Yes,N,12/21/2020,12/22/2020,1.0,PVT,phenobarbital 60mg HS hydroxychloroquin 400mg HS famotidine 20mg HS occas acetaminophen or ibu,had surgery R hand for advanced arthritis 11/16/20 - arthrodesis R thumb. was recuperating,Rheumatoid arthritis - mostly affecting R wrist well controlled seizure disorder DJD,,bee stings,"['Chills', 'Complex regional pain syndrome', 'Fatigue', 'Headache', 'Joint range of motion decreased', 'Myalgia', 'Pain in extremity', 'Peripheral swelling', 'X-ray abnormal']",1,PFIZER\BIONTECH,SYR 916743,CA,45.0,F,Bilateral tinnitus- non stop since the day of the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,PVT,Junel Fe 1/28 (birth control) Azuline nasal spray Singular 10mg,,,,,['Tinnitus'],1,PFIZER\BIONTECH,IM 916745,IN,58.0,F,"Diarrhea times one on December 30, loose stool times one on December 31, Loose stools January 1.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/20/2020,12/30/2020,10.0,UNK,,,,,,['Diarrhoea'],UNK,PFIZER\BIONTECH, 916747,MS,57.0,F,"Headache, significant body aches, fever up to 104",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,Low dose aspirin Omeprazole 40 mg Lisinopril HCTZ 20/12.5 x2 Rosuvastatin Calcium 20 mg Synthroid 137 mcg Meloxicam 15 mg,None,"Hypothyroidism, HTN",,None,"['Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 916748,MI,56.0,F,"Dizziness immediately after injection, anxiety, questionable tongue thickening. Then canker sores on tongue, lips swollen later in day and next day. No breathing issues.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,Welbutrin ibuprofin,,,,Sulfa,"['Anxiety', 'Aphthous ulcer', 'Dizziness', 'Immediate post-injection reaction', 'Lip swelling', 'Tongue disorder']",UNK,PFIZER\BIONTECH, 916749,,33.0,M,"Arm soreness at injection site, fatigue, body aches, slight headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,UNK,None,None,None,"Fever, 18, meningitis vaccination",None,"['Fatigue', 'Headache', 'Injection site pain', 'Pain']",UNK,MODERNA,SYR 916750,NJ,38.0,F,Fevers high as 104.4 Came down with Tylenol x3 Severe body aches Headache Dizziness Baseball size lump under armpit of injection site arm 2 days post injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,Metformin 1000mg BID Losartan 50mg daily Lopressor XR 50 mg daily Lexapro 20 mg daily Singulair 10mg daily Vitamin D3 2000units daily Aspirin 81mg daily Nortrel 35mcg daily Wellbutrin 100mg daily,None,Polycystic Ovary Syndrome Type II Diabetes Hypertension PTSD,,Percocet,"['Axillary mass', 'Dizziness', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 916751,PA,27.0,F,"One week after my first dose of the Moderna COVID 19 vaccine (administered 12/24) I developed a large, itchy rash/hives at the injection site. The hives began 12/30 and are still present.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/30/2020,6.0,PVT,"Junel Fe birth control, B12 supplement",,,,"hazelnuts, trees, grass, weeds, animals (cats, dogs, gerbils), cockroaches, dust mites","['Injection site reaction', 'Injection site urticaria', 'Rash pruritic']",1,MODERNA,SYR 916753,MS,41.0,F,"Fever, chills, aches, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/22/2020,1.0,UNK,,,,,,"['Chills', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 916754,TN,52.0,M,on Tuesday of the next day after the vaccine shot I couldn't use my raise or lift my left arm and it was swollen and I was very fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,UNK,,,,,,"['Administration site joint movement impairment', 'Fatigue', 'Injection site swelling']",1,MODERNA,SYR 916755,NJ,25.0,F,Severe arm pain hours after injection. Lasted for two days Nauseous and vomiting day 2 and 3 with headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,UNK,Sertraline Ajoovy,,,,None,"['Headache', 'Nausea', 'Pain in extremity', 'Vomiting']",1,MODERNA,SYR 916756,IL,45.0,F,"Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness and swelling. Went to ER, treated with IV Benadryl, Epinephrine, Famotidine, Solumedrol, Klorcon M.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,Telmisartan HCTZ,,Hypertension,,Tree nuts,"['Amino acid level', 'Anaphylactic reaction', 'Differential white blood cell count', 'Ear swelling', 'Erythema', 'Full blood count', 'Hypersensitivity', 'Hypoaesthesia', 'Metabolic function test', 'Pharyngeal swelling']",1,PFIZER\BIONTECH,IM 916757,IA,31.0,F,Bilateral adenopathy - Day 6 to present Severe arm pain - Day 6 to present Arm weakness - Day 6,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/30/2020,6.0,PVT,,,,,,"['Lymphadenopathy', 'Muscular weakness', 'Pain in extremity']",1,MODERNA,IM 916758,VA,56.0,M,"Developed fatigue, muscle aches, chills, low grade temperature of 99.4, and night sweat.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,"Hydrochlorothiazide, Losartan, aspirin, Mestinon, prednisone, multi-vitamin, Vit D3 and Vit C.",None,"Myastenia Gravis, hypertension",,None,"['Chills', 'Fatigue', 'Myalgia', 'Night sweats', 'Pyrexia']",1,MODERNA,IM 916759,VA,30.0,F,"12/28/2020-1230 began feeling numbness/tingling left foot, left hand, left cheek (face), intermittent 1500- chest tightness, palpitations lasting 20-30 minutes 1900- feet b/l ice cold, muscle aches, chills, lasting 8 hrs 12/29/2020- upon awakening-fatigue, SOB 6 hrs, intermittent paresthesia persist left foot, left cheek, new onset teeth pain (lasts less than 1 minute) left sided headache (1-5 min) left sided back pain at SI joint 12/30- tingling sensation persist, fatigue is gone. Chills- 1-3 min duartion, intermittent. left ear pain, left headache, ""pings "" of left cheek, tingling back pain persists (left) 12/31/2020 noted mild left facial weakness-, left eye brow rise, unilateral wrinkle forehead, smile reduced left sided tingling persists with intermittent headache, ear pain, teeth pain sought care of PCP tx of early onset bells palsy with steroid taper + PPI Began prednisone 40 mg PO 1/1/2021 left sided back pain persists",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,PVT,Pentasa (mesalamine) 3 to 4 gm/daily pepcid 20 mg Po daily vitafusion women's prental folic acid 1 mg b12 1000 mcg po daily tylenol 500 mg flonase prn loratadine prn albuterol prn exercise,no illnesses at time of vaccine,crohn's disease asthma,,"pyridium (flushing, sob) lactose intolerance (GI) bee stings (rash/swelling) no anaphylaxis","['Arthralgia', 'Back pain', 'Chest discomfort', 'Chills', 'Dyspnoea', 'Ear pain', 'Facial paralysis', 'Facial paresis', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Myalgia', 'Palpitations', 'Paraesthesia', 'Peripheral coldness', 'Toothache']",1,PFIZER\BIONTECH,IM 916760,CA,30.0,F,"Fever , headache body aches , nausea and vomiting . Hives",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,Levothyroxine,"COVID dec 2 ,2020",,,,"['Headache', 'Nausea', 'Pain', 'Pyrexia', 'Urticaria', 'Vomiting']",UNK,MODERNA,SYR 916761,MD,25.0,F,"Redness and swelling on left arm of injection site. Experienced nausea later that day of injection. The next day experienced headache, chills, nausea and vomiting. Never reached a fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,Birth control: Estarylla (0.25-0.35 mg) 1 pill a day Prescription: Duloxetine (30 mg) 1 pill a day Temporary Prescription: Sulfameth/Trimethoprim (800/160mg) Take two a day Over the counter up4 Probiotics (2 gummies a day),Staph Infection notified on 12/16/2020. Been taking Sulfameth/Trimethoprim (800/160mg) Take two a day since 12/17/2020.,,,zythromax and amoxicillin. fried seafood.,"['Chills', 'Headache', 'Injection site erythema', 'Injection site swelling', 'Nausea', 'Vomiting']",1,MODERNA,SYR 916762,CA,54.0,F,"Fevers, muscle, joint aches, fatigue, ""crawling skin""extreme thirst X6 days as of this form",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/27/2020,1.0,OTH,"Losartin, metoprolol, Pamelor, Hydroxycloroquine, Vit D, Vit C . Multi B, CoQ10",None,HTN Arthritis,,Kiwi,"['Arthralgia', 'Fatigue', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test negative', 'Skin discomfort', 'Thirst']",UNK,PFIZER\BIONTECH,IM 916764,,53.0,F,"Fever, chills and aches",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/22/2020,0.0,UNK,,,,,,"['Chills', 'Pain', 'Pyrexia']",1,MODERNA,IM 916765,NY,49.0,F,"Same day - pain at the injection site, slight swelling 1/1/2021 - headache, fatigue, nausea, diarrhea,",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/01/2021,2.0,WRK,"Vyvanse, Pristiq, Lamictal, Magnesium Glycinate, Protonix, folic acid, multi-vitamin",None,None,,Sulfa,"['Diarrhoea', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Nausea']",UNK,MODERNA,IM 916766,ME,35.0,F,"Moderna COVID-19 Vaccine EUA 12/23/20: -in the evening I began feeling pain in my whole left arm from shoulder to wrist Which lasted 4 days -had chills and felt extremely cold to the point where multiple blankets, layers of clothes and drinking hot tea did not make me feel warm; this lasted until 12/24/20 -general fatigue that lasted until 12/24/20 Beginning 12/31/20: - a rash developed on my left arm at the injection site. It is itchy and warm to the touch. It has persisted through Benadryl and not gotten better",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,WRK,Adderall,,Adhd,,No known allergies,"['Chills', 'Fatigue', 'Feeling cold', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 916767,AK,54.0,F,"Hypotension noticed 24 hours post injection. Effect lasted for 48-72 hours while improving. Lowest BP 85/60, with symptoms: lightheaded at rest.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,Irbesartan 150mg qd am,,HTN,,Sulfa Dicloxicillin,"['Dizziness', 'Hypotension']",UNK,PFIZER\BIONTECH, 916768,IN,56.0,F,"extreme chills, myalgias, nausea, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,Advair diskus,none,none,,none,"['Chills', 'Myalgia', 'Nausea']",1,MODERNA,IM 916769,TX,48.0,M,"Woke up w severe chills that night/next morning. Fever was 101.8. Took 50 mins in hot shower to get warm. Then had severe headache and body (back) aches. I began taking ibuprofen that night/morning. I remained in bed under 5 layers of covers for all of the 30th and until the afternoon of the 31st. My fever went down to 99.1 and then back to 100.8. I have not had any chills since. I have no fever and no headache as of now, 1/1/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PUB,"Methylphenidate, citalopram, rosuvastatin",None,None,,Nkda,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 916770,KS,23.0,F,Moderna COVID-19 Vaccine EUA. Muscle soreness at injection site starting about 1 hour after and continued the day after that. Little muscle soreness on the third day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None,None,None,Muscle soreness only with seasonal flu shot,,['Injection site pain'],1,MODERNA,IM 916771,AR,30.0,F,"Headache, sore arm to injection site, dizzy, numbness to right foot. No medications taken. Continues to have symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,SEN,None,No,Asthma,,Fish,"['Dizziness', 'Headache', 'Hypoaesthesia', 'Injection site pain']",1,MODERNA,IM 916772,GA,55.0,M,Vaccine on 12/22/2020 and started feeling bad on 12/27/2020 and tested positive on 12/30/2020 for COVID 19 Was advised to fill this out by my PCP,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/26/2020,4.0,PUB,"Propranolol,zoloft,asa,Lisinipril, Crestor, Protonix, CoQ10, Fish oil, Sonata, Melatonin, Zertec,B-12,",,"HTN, Insomnia,High Cholesterol,",,Codeine,"['Feeling abnormal', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,IM 916773,TX,63.0,F,"1:28p - Within one minute of vaccine administration left hand felt tingling and numb which was followed by by a warm feeling in the left arm . 1:40p - Felt warm (flushed) all over, dizziness, lightheadedness, heart racing (palpitations), numbness and tingling in left foot. Blood pressure taken 151/89, P 80 using wrist monitor 1:45p - Symptoms began to pass. Blood pressure 151/89, P 80 1:55p - Felt flushed again. Blood pressure 165/79, P 80 2:05p - Symptoms began to pass. Blood pressure 153/73, P73 2:20p - Riding home both knees to feet feeling numb and tingling 2:43p - took Ranitidine 150 mg 3:00 p - blood pressure 128/57, P61 5:00p - left foot numbness continues 10:00p - Took tylenol 500 mg",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Plendil, hydrochlorothiazide, allegra, multivitamin, biotin, allergan ophthalmic solution, latanoprost ophthalmic solution, women's rogaine",none,"hypertension, well-controlled on medication",,none,"['Dizziness', 'Feeling hot', 'Flushing', 'Hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 916774,,50.0,F,"Fever, chills, and aches",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/23/2020,1.0,UNK,,,,,,"['Chills', 'Pain', 'Pyrexia']",1,MODERNA,IM 916775,NY,54.0,F,"12/25/20-12/26/20: arm soreness, extreme fatigue ~2 hours after vaccine. I slept for significant portions of the remainder of 12/25 through 12/26 and had no problems with sleep overnight. 12/27/20: 30% improvement of exhaustive fatigue, arm soreness, mental fog, headache, decreased appetite, low grade fever, chills 12/28/20-12/30/20: fatigue, arm soreness, mental fog, headache, decreased appetite (+food aversion), nausea (not related to not eating), low grade fever, chills, body aches, joint pain, rhinnorhea, and laryngitis 12/30/20-1/1/21: fatigue, mental fog, headache, decreased appetite (general food aversion), nausea, low grade fever, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/25/2020,12/25/2020,0.0,WRK,Lisinopril 20mg daily (started ~4/2018) Lipitor 40mg daily and Baby Aspirin (started ~3/2020) Zoloft 100mg daily (started 8/2019 after my mother's death) Adderall XR 40mg daily (many years) Nature Care MVI w/iron and Nature Care Vitamin D,None,"Hypertension, high cholesterol (under control-180 on 12/32/20) only 220's Diagnosed with mild aortic stenosis 2/2020 ADHD Hx of abnl pap/mild cervical dysplasia, +HPV-16; last two paps were negative Lumbar spondylosis, disc extrusion L4-L5 (compression of left L4 nerve root)- onset of symptoms 1/2020",,"NKDA or to foods Environmental allergy to dust-mild-NO RX; rhinorrhea, few occasions of mild wheezing, no SOB, w/prolonged exposure when cleaning basement Seasonal allergy to cut grass in the Spring, but only if I am doing the mowing-mild-NO RX; rhinorrhea, watery eyes, mild wheeze, no SOB","['Arthralgia', 'Chills', 'Decreased appetite', 'Fatigue', 'Feeling abnormal', 'Headache', 'Hypersomnia', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Laryngitis', 'Nausea', 'Pain', 'Pain in extremity', 'Polymerase chain reaction', 'Pyrexia', 'Respiratory syncytial virus test negative', 'Rhinorrhoea', 'SARS-CoV-2 antibody test negative', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 916777,MI,30.0,F,"Chills, myalgias and pre-syncope",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,PVT,Omeprazole OCP Mirtazapine Escitalopram,None,"Anorexia, in remission Anxiety GERD",,Olanzapine (prolonged QTc),"['Chills', 'Myalgia', 'Presyncope']",1,PFIZER\BIONTECH,IM 916778,RI,31.0,F,"I am a surgical resident who had covid in November. Date of my symptom onset was 11/13/20. My positive test was on 11/14/20. I was moderately ill with covid, but did not require hospitalization. I was offered a vaccine and accepted on 12/28/20. I got the modern vaccine. On 12/29 AM I developed significant symptoms. I was so exhausted and sore I was barely able to complete my cases for the day. I only had a temp max of 99.7, but I felt worse the I did when I had covid (except for the respiratory symptoms). I came home by noon in 12/29 and took Motrin then went to sleep by 1400. As soon as I woke up on 12/30 I took aleve 400 mg and felt well enough to work the next day. Symptoms improved progressively in the subsequent days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,UNK,"adderall XR, sertraline, famotidine","None, but, as noted above, I had covid symptoms starting 11/13/20 and a positive test from 11/14/20",ADHD anxiety,,PABA,"['Body temperature increased', 'Fatigue', 'Pain']",1,MODERNA,IM 916779,,21.0,F,"Pain and swelling at site of injection, fatigue, chills, severe body aches, headache, and a low-grade fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,UNK,,,,,,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Pain', 'Pyrexia']",1,MODERNA,SYR 916780,AR,88.0,F,Chills. They have resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,SEN,"Levothyroxine, Lasix, Colace, potassium, Cetirizine, Amlodipine, Metoprolol Tartrate, Simvastatin, Folic Acid, AZO Cranberry",NONE,"CEREBROVASCULAR DISEASE, HEART FAILURE, ABDOMINAL AORTIC ANEURYSM, ARTHROPATHY, ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS, ANXIETY DISORDER, ESSENTIAL (PRIMARY) HYPERTENSION, NAUSEA WITH VOMITING, UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE, HYPOTHYROIDISM, ANEMIA",,PCN,['Chills'],1,MODERNA,IM 916781,GA,67.0,F,"1/1/2021 - Experiencing headache, feeling weird all over. Tightness in chest. comes and goes. Will call Doctor on Monday if still feeling the same.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/01/2021,4.0,PVT,Amlodipine 10 mg./day Vitamin D 4000iu/day Omeprozole 40 mg/day Advil prn Tagamet prn,none,none,,Reglan - anaphylaxis Narcotics - severe nausea & vomiting popcorn,"['Chest discomfort', 'Feeling abnormal', 'Headache']",1,MODERNA,IM 916782,HI,30.0,F,"The next day I had a sore throat, and now it has developed into a cold. Sore throat, running nose, had some chills and body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,,None,None,,None,"['Chills', 'Nasopharyngitis', 'Oropharyngeal pain', 'Pain', 'Rhinorrhoea']",1,PFIZER\BIONTECH,IM 916783,WV,42.0,M,"8.5 hours after vaccination, client altered sensation in skin at arm and chest. felt like a sunburn, with a dull itch, discomfort. Took OTC benadryl, but it did not offer relief. Went to ED that same evening and was given Solumedrol. No epinephrine received. Next day, taking 50 mg diphenhydramine PO. Next day, rash now at arms/legs /back . none at chest. Meds helping with discomfort.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,"Prescription NSAID for a sprained shoulder, taking BID for 5 days","sprained shoulder for 5 days, otherwise none",none,,none,"['Paraesthesia', 'Pruritus', 'Rash', 'Skin discomfort']",1,MODERNA,IM 916784,OH,47.0,F,"Shortly after receiving the shot was dizzy light headed with visual changes. It cleared up within 10-15 mins. Later that evening around 630 or 7 pm had headache, body aches, and Severe chills. No fever. Intermittent dizziness and visual changes. This lasted until Thursday evening. On Friday I felt fine but as I began to move around more the dizziness has returned",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,None,,"Crohn?s disease, benign fibrocystic disease, htn",,Flagyl,"['Dizziness', 'Headache', 'Pain', 'Varicella', 'Visual impairment']",UNK,MODERNA,SYR 916785,TX,35.0,F,After receiving the vaccine I began to feel lightheaded and short of breath. I felt tachycardiac and felt like passing out. I got transferred to the er where I received the epipen along with oxygen and antiseizure meds for my seizure. I was then transferred to Medical Center for further care where I was later discharged.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,"ASA, Keppra, Verapamil, Flecainide, Eliquis, Depo-Provera, Ambien",Congenital Heart Disease,"Congenital Heart Disease, History of Seizures",,"Demerol, Nubain, Vancomycin, Morphine, Triamterene-HCTZ","['Altered state of consciousness', 'Cardiac function test normal', 'Chest X-ray normal', 'Dyspnoea', 'Feeling of body temperature change', 'Full blood count normal', 'Influenza virus test negative', 'Metabolic function test normal', 'Polymerase chain reaction', 'Respiratory syncytial virus test negative', 'SARS-CoV-2 test negative', 'Seizure', 'Tachycardia']",UNK,PFIZER\BIONTECH,IM 916786,MN,39.0,F,"Tiredness, fever (101.2), chills, muscle pains, headach, feeling unwell",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,OTH,None,None,None,,Amoxcecillan,"['Chills', 'Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 916787,FL,54.0,F,"Raised red area, that did not itch but became a circle of scabs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,WRK,"zyrtec, loestrin( BC)",none,none,,"seasonal allergies, dust, pollen, grasses, oak","['Erythema', 'Scab', 'Swelling']",1,PFIZER\BIONTECH,IM 916788,IL,51.0,M,"Highest Fever 102.4, Body Aches, Headaches Still occuring after 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,SEN,"Clonazepam 0.5mg, Atorvastatin 10mg,",None,Had Coronavirus May 2020. Isolated for 2 weeks.,,None,"['Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 916789,VA,55.0,M,"Patient had mild symptoms immediately after injection- his skin felt dry, uncomfortable. Symptoms progressed. ny 5pm (4 hours post vaccination), his voice changed, throat was swelling, lips tingling, congestion in throat, nose. Sought treatment at ED: received Solumedrol, Benadryl and Pepcid. No Epinephrine. Told Anaphylactoid reaction. monitored 4 hours in ED, then discharged to home. FU with PO benadryl. Some congestion persisted 24 hours after event.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,OTH,"Type 2 diabetes medicine: insulin, trulicity, wellbutrin, welchol",,"Diabetes, stomach issues",,"SHELLFISH, PCN, LATEX","['Anaphylactoid reaction', 'Dry skin', 'Dysphonia', 'Immediate post-injection reaction', 'Increased upper airway secretion', 'Nasal congestion', 'Paraesthesia oral', 'Pharyngeal swelling', 'Skin discomfort']",1,MODERNA,IM 916790,TN,52.0,F,"Flushing, sweating, increased heart rate proceeded to feel difficulty swallowing and clearing my throat. I was taken to the ER. The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea and feeling very unwell.",Not Reported,,Yes,Not Reported,,Not Reported,U,12/26/2020,12/26/2020,0.0,PVT,"Estradiol, topiramate, Emgality, sumatriptan, multivitamin",,"Asthma, migraines",,"Sulfa, shellfish","['Blood pressure diastolic increased', 'Blood pressure systolic increased', 'Chest discomfort', 'Dizziness', 'Dysphagia', 'Electrocardiogram', 'Flushing', 'Heart rate increased', 'Hyperhidrosis', 'Malaise', 'Nausea', 'Speech disorder', 'Throat clearing']",1,PFIZER\BIONTECH,IM 916791,OH,38.0,F,"Fatigue, headache, injection site sore and red.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,PVT,,None,HTN,,Grass and tree pollen,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain']",1,MODERNA,IM 916792,TX,57.0,F,"Jan 1st, woke with an itchy lesion on lower left arm on the exact spot that I had a previous PPD test done years ago. (Can't have PPD done anymore due to allergic reaction). This new lesion appeared to look just like the PPD reaction with raised swelling, redness and itch. Applied Benadryl cream and swelling and itch went away within 4 hours leaving a red spot. I have photos documenting it from start to end.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/01/2021,3.0,PVT,"Duloxetine, ibuprofen, Slow-Fe OTC, Flonase Sensimist",Asthma,"Osteoarthritis, glaucoma, asthma",,"PPD serum, codeine, iodine, Spiriva, valium, adenosine, Ativan.","['Erythema', 'Pruritus', 'Skin lesion', 'Swelling']",1,MODERNA,IM 916793,MN,39.0,F,"Red, warm, hard knot at injection site. Site is extremely itchy and sore. Body aches, pains, malaise and headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,MIL,Methylphenidate 36mg QD Venlafaxine 75mg QD hydroxyzine 50mg QD Gabapentin 300mg BID Estradiol patch 0.1mg/24,"COVID 19, diagnosed 12/15/2020","Depression, Anxiety, Narcolepsy",,Modafinal Shellfish,"['Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Malaise', 'Pain']",1,MODERNA,IM 916794,TX,38.0,F,"arm soreness for the past 7 days. 12/31/2020 had red itching rash at injection site. today rash still there with continued muscle soreness, including neck soreness now.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/31/2020,7.0,OTH,levothyroxine amitriptyline progrestrone ibprofen,none,endometriosis - surgery 11/6/2020,,none,"['Injection site reaction', 'Myalgia', 'Neck pain', 'Pain in extremity', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,SYR 916795,MI,43.0,F,"Soreness at injection site 3 hours post injection. 30 hours post injection, pt experiences a huge blood clot from vagina, about the circumference of a clementine. was not old blood, looked like frank blood. over the next 30 hours, pt experiences more clots, much smaller, about the size of a pea. pt has a headache and chills throughout. 48+ hours, experiencing what feels like menstrual cramps. no blood clots 72 hours post injection",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,PVT,600 mg Ibuprofen,,,,,"['Chills', 'Dysmenorrhoea', 'Headache', 'Injection site pain', 'Thrombosis']",1,PFIZER\BIONTECH,IM 916797,MO,31.0,F,"Around 10:30pm had symptoms of fever and chills. In the morning had symptoms of chills, headache, increased heart rate, and slight nausea. On 1/1/2020 around 11:30am had slight swelling and tenderness on the left side of the neck right above the clavicle bone. Decrease of symptoms starting the morning of 1/1/2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,None,None,None,,None,"['Chills', 'Headache', 'Heart rate increased', 'Nausea', 'Pyrexia', 'Swelling', 'Tenderness']",1,MODERNA,IM 916798,NC,23.0,F,Moderna COVID-19 Vaccine EUA Severe headache Fatigue Nausea Body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,OTH,IUD,Covid 19 in late November 2020,No,,No,"['Fatigue', 'Headache', 'Nausea', 'Pain']",1,MODERNA,IM 916799,AR,42.0,M,tachycardia Heartrate went from 88 to 110 resolved in less than 1 hour,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,SEN,,,,,,"['Heart rate increased', 'Tachycardia']",1,MODERNA,IM 916800,MO,32.0,F,"Extreme fatigue, diarrhea, vomiting, fever, chills, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,SEN,Sertraline,None,None,,Sulfa,"['Chills', 'Diarrhoea', 'Fatigue', 'Pain', 'Pyrexia', 'Vomiting']",1,MODERNA,SYR 916801,IN,60.0,F,"Got vaccine at 11am, was ok all day. About 11pm I felt nauseated. Got up a 2am to go to bathroom and had teeth-chattering chills. 30 minutes later vomited several times. Fever was 99.6 last night, 99.8 this morning, and 100.2 this afternoon. Significant pain in joints, moderate in muscles. Feel by far worse than when I had covid. Though these side affects typically resolved in 24 hours? Mine are no better, other than I'm only nauseated, not throwing up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,OTH,"Synthroid, hydroclorathiazide, amlodipine, sertraline, Vitamin D3, occuvite, multiple vitamin methyl B complex","Covid 19, positive 12/13/20","recent high blood pressure, hypothyroidism, nothing major",,"no meds, I dont' know about food, and some environmental allergies","['Arthralgia', 'Chills', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 916802,FL,42.0,F,"Rapid heart rate, arrhythmia felt at 7pm 12/30, still present in morning 12/31/20, at 7:00 am was found to be in afib on monitor at work (I am a surgeon). Treated in emergency room after EKG confirmed a-fib. Received potassium and flecainide and converted to normal sinus rhythm after several hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/15/2020,12/30/2020,15.0,WRK,"Multivitamin, biotin, B12, iron",None,None,,Zoloft,"['Arrhythmia', 'Atrial fibrillation', 'Blood potassium decreased', 'Chest X-ray normal', 'Electrocardiogram abnormal', 'Heart rate increased', 'Laboratory test']",1,PFIZER\BIONTECH,IM 916803,LA,78.0,M,respitory colase,Yes,10/18/2020,Yes,Yes,8.0,Not Reported,N,10/06/2020,10/10/2020,4.0,PVT,"Lisinopril, Novolog,, Lantus Solostar, Gabapentin, Glusosamine-chondrotin, Lanaoprost, Alphagan, Metoprol Tartrate, Colocrys. . as needed, Chlorthlidone.",none,"large T-cell lymphoma, HTN, Gout, recieving treatment for fluide in lags",,N?A,"['Death', 'Pneumothorax']",4,SANOFI PASTEUR,IM 916804,CT,24.0,F,"After 15 minutes: tingling/itchiness in my fingertips, tongue and lips, felt weak/lightheaded and dizzy, weak pulse, rapid HR (98 bpm) normally resting HR is around 58-62 bpm. Symptoms kept increasing and after 30 minutes: felt lump in throat when swallowing/difficulty, eyelids super itchy, significant hives on chest and neck developed. A nurse at the site monitored me, told me to get benadryl on the way home, had to have boyfriend pick me up from the clinic to drive me home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,Lo Loestrin Fe birth control Flonase,Sinus infection 2 weeks ago,Asthma Allergies (pets and seasonal) Varicose Veins,,Amoxicillin/Penicillin,"['Asthenia', 'Dizziness', 'Dysphagia', 'Eyelids pruritus', 'Heart rate increased', 'Paraesthesia', 'Pruritus', 'Pulse abnormal', 'Sensation of foreign body', 'Urticaria']",UNK,MODERNA,SYR 916805,NY,52.0,M,"Started with acute onset fatigue and chills(at the same time,9pm). Spiked a 104.5 temp @ aprx 2 am. Went back and forth between chills/fever for 15 hours. Slept for 13 hours and felt fine when I woke up. Body Aches and headaches were also felt the whole time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Lisinopril, synthroid, testosterone shot(8 week)",6 weeks since recovering from covid exposure. I was very symptomatic during this period(aprx Nov18-26th w/symptoms),"Low Thyroid function, boarderline HBP",,citrate solution,"['Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Hypersomnia', 'Pain']",2,MODERNA,IM 916807,AR,24.0,F,metallic taste,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,SEN,,,,,,['Dysgeusia'],1,MODERNA,IM 916808,CA,58.0,F,painful right wrist and right hard that limits movement started appropriately at 2200 on 12/31/2020,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PVT,"benazepril hcl 10mg (1 daily),Women's formula one a day (1 daily), magnesium 250mg (2 daily), acetaminophen 250mg (2 daily), Aspirin 250mg (2 daily), ibuprofen 200mg (4 daily), turmeric 1000mg (2 daily)",none,"Arthritis, HTN",,"sulfa, vytorin, ginger (spice)","['Arthralgia', 'Mobility decreased', 'Pain in extremity']",1,MODERNA,IM 916809,WA,40.0,F,"CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITCH, FOLLOWED BY UNCONTROLLED SHAKING, WITH HIGH FEVER FOLLOWED BY SEVERE SHORTNESS OF BREATH AND GASPING, WITH TIGHTNESS AROUND THE CHEST. TRANSPORTED TO EMERGENCY DEPARTMENT. HAD MULTIPLE EPISODES OF ITEMS LISTED ABOVE WHILE IN ED, INCLUDING HEAVINESS IN HER LEGS AND TINGLING IN ARMS. SHE WAS DISCHARGED FROM ED AT 10:30PM BUT WAS READMITTED ON 12/24 TO ED FOLLOWING SIMILAR ISSUES. TO DATE SHE HAS HAD 5 RAPID RESPONSES IN HOSPITAL DUE TO REPEAT OF SIGNS/SYMPTOMS. CT AND PULMONOLOGY CONSULT SCHEDULED FOR 12/28/2020.",Not Reported,,Not Reported,Yes,9.0,Not Reported,U,12/23/2020,12/23/2020,0.0,PVT,,None,,,None,"['Blepharospasm', 'Chest discomfort', 'Computerised tomogram', 'Dizziness', 'Dyspnoea', 'Limb discomfort', 'Paraesthesia', 'Pyrexia', 'Tremor']",1,PFIZER\BIONTECH,IM 916810,,27.0,M,"Chills, headache, fatigue, muscle aches, hot flashes, profuse night sweats. Has lasted more than 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,PVT,none,"COVID symptoms started 14 days (12/15) prior to vaccination. Tested positive for COVID 12 days (12/17) prior to vaccination. Mild covid symptoms quickly went away, was cleared from isolation 4 days prior to vaccination (12/26)",none,,none,"['Chills', 'Fatigue', 'Headache', 'Hot flush', 'Myalgia', 'Night sweats']",1,MODERNA,IM 916811,TX,54.0,F,"No adverse reaction on the date the Moderna COVID-10 Vaccine EUA was given. The following day, Thursday, 12/24/20, I felt pain at the site of injection. When I checked my arm I had a large, painful, red, round, raised bump. It became more erythematous, painful, and larger the next day, Friday, 12/25/20. The pain, swelling, size, and erythema slowly started going away over the next few days. Wednesday 12/30/20 and Thursday, 12/31/20 the area was nearly back to normal. Today, Friday, 1/1/21, I felt itchy at the site of injection. When I checked it I had large round area of erythema at the site of injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,,None,None,,NKA,"['Erythema', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Pain in extremity', 'Peripheral swelling']",UNK,MODERNA,UN 916812,CO,57.0,F,"REDNESS AT INJECTION SITE (WHICH IS COMMON) BUT BECAME MORE RED AND ITCHY AFTER 9 DAYS. STILL VERY SWOLLEN, RED AT SITE, AND PT REPORTS VERY ITCHY",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,PHM,UNKNOWN,NO KNOWN,NO KNOWN,,BACTRIM,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,PFIZER\BIONTECH,SYR 916813,NY,62.0,F,"For several days, the usual arm soreness. Approx. 7 days following, a large red area with intense itching which continues today. Photos are available. No other symptoms (fatigue, fever, body aches, etc.) -- just the injection site area is now extremely itchy and still tender to the touch. To treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/29/2020,7.0,WRK,vitamin D 2000 IU multi vitamin 1500 mg calcium (Tums),,,,sulfa alcyclovir,"['Erythema', 'Injection site pain', 'Injection site pruritus', 'Pain in extremity', 'Pruritus']",UNK,MODERNA, 916814,TX,51.0,F,"Blisters in mouth first, then on arms, chest and legs. Itchy red blisters-This is usually a symptoms on my Lupus",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/27/2020,3.0,PVT,"Nexium, Effexor, Lisinopril, Metoprolol, Hydroxychloroquine",No,Lupus (SLE),,"Bananans, Cat's, IV Zofran","['Blister', 'Erythema', 'Oral mucosal blistering', 'Pruritus']",UNK,MODERNA,SYR 916815,,41.0,F,redness and swelling over three days. red chest and itchiness along chest and back two hours after vaccination. no hives.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,,,,,MRI Dye,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA,IM 916816,,41.0,F,redness and swelling over three days. red chest and itchiness along chest and back two hours after vaccination. no hives.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,,,,,MRI Dye,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA,IM 916817,FL,40.0,F,"Low grade fever 100 1800 12/30/20. Fever 103, chills, body aches 0100 12/31/20. Low grade fever 12/31/20 until 1400 Had to take Tylenol to break fever and relieve headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Levothyroxine, Xanax",,,,Cats,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 916818,NY,29.0,F,"nausea, myalgia, chills, temp 100.5",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,,,,,,"['Body temperature increased', 'Chills', 'Myalgia', 'Nausea']",1,PFIZER\BIONTECH,IM 916819,OH,33.0,F,"I developed a red firm itchy raised rash at the injection site over a week after my vaccine, see dates listed above.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PVT,None,None.,Obesity,,None.,"['Injection site induration', 'Injection site reaction', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",1,MODERNA,IM 916820,TN,55.0,M,"Approximately 12 hours post vaccination employee reported hives consisting of raised, itchy whelps from their waist to their ears. Hives reported as moderate to severe - kept employee up all night due to severe itching. Employee reports no increased heart rate, no difficulty breathing or shortness of breath, no fever, no direct pain or redness aside from the hives a the injection site, no nausea no vomiting. Employee took a dose of Benadryl when hives started, this seemed to resolve about 50% of them by 8am the following morning, a second dose of Benadryl was taken at 8am 12/31/2020, and by 12pm 12/31/2020 the hives were gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Unknown,None reported,None reported,,None reported,"['Injection site urticaria', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 916821,IL,23.0,F,"Soreness at injection site , high fever later that night of 101.6 and chills and body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Chills', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 916822,TX,46.0,M,"Itching, swelling and tenderness to injection site starting 7 days after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PVT,,,,,,"['Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 916823,NV,41.0,F,"Moderna COVID-19 Vaccine EUA; Painful swelling in lymph nodes in the axilla of the injection side; localized redness, swelling, and itching of injection site, and full body hives.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/29/2020,6.0,PVT,None,None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Lymph node pain', 'Lymphadenopathy', 'Urticaria']",1,MODERNA,IM 916824,CA,39.0,F,"First dose of Moderna COVID-19 EUA. about 3 days after first dose developed mild nausea, weakness, fatigue/mental fog, mild dizziness/feeling lightheaded, dry throat and mildly sore throat and ear (nasopharyngeal) Still feeling this way on day 4 (that is today the day I am reporting)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/31/2020,3.0,WRK,"multivitamin, omega-3, have been taking these a long time",Suspected autoimmune type reaction following Fluvax October 2020- developed Cold Urticaria (hives in response to cold stimulus) a few days after flu vaccine,Low BMI of 16- underweight for last 10 years,Fluzone 10/5/2020 developed Cold Urticaria and mild flu like sxs about 4 days after vaccine,None,"['Asthenia', 'Dizziness', 'Dry throat', 'Ear pain', 'Fatigue', 'Feeling abnormal', 'Nausea', 'Oropharyngeal pain']",2,MODERNA,IM 916825,AR,45.0,F,metallic funny taste and heart palpitations,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,SEN,,,heart condition,,,"['Dysgeusia', 'Palpitations']",1,MODERNA,IM 916826,AR,78.0,F,Increased fatigue.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,SEN,"Isosorbide Mononitrate ER, Allopurinol, Carvedilol, Protonix, Novolin 70/30, Gabapentin, Zoloft, hydralazine, Bumetanide",Covid-19,"OTHER SEQUELAE FOLLOWING UNSPECIFIED CEREBROVASCULAR DISEASE, TYPE 2 DIABETES MELLITUS WITH DIABETIC NEUROPATHY, UNSPECIFIED, COPD, ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS, GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS, OTHER IDIOPATHIC PERIPHERAL AUTONOMIC NEUROPATHY, HYPERLIPIDEMIA",,NKA,['Fatigue'],1,MODERNA,IM 916829,CA,37.0,F,"Tuesday 12/29 - Initially pruritis, erythema and unraised rash to L antecubital fossa. Wednesday 12/30 - Woke up with post nasal drip, congestion, scratchy throat, nausea. Pruritis, erythema and non raised rash to bilateral antecubital areas. Had intermittent chills without fever. Had muscle aching. Thursday 12/31 - Started to have pruritis to abdomen, no rash noted. Continue to have pruritis, erythema, non raised rash to bilateral antecubital areas. Continue to have post nasal drip, congestion, scratchy throat (none worse than the day before). No chills, only muscle aching. Friday 1/1 - Same as 12/31 so far.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/29/2020,5.0,PVT,"Isibloom, Claritin, Prenatal vitamin, Folic acid, Vitamin D, probiotic",None,None,,"DayQuil, Hypercare, glycerin (in skin products and food), coconut oil (applied to skin)","['Chills', 'Erythema', 'Myalgia', 'Nausea', 'Pruritus', 'Rash', 'Respiratory tract congestion', 'Throat irritation', 'Upper-airway cough syndrome']",1,PFIZER\BIONTECH,IM 916830,MT,29.0,F,Had chills all night. Severe headache and body aches started around 10pm (vaccination was around 11am). I felt great for a few hours immediately following vaccination but developed severe light-headedness that evening. Passed out the following morning (01/01/2021) and my daughter called 911/ paramedics. I declined going to the hospital but I still feel horribly dizzy and ache.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PUB,Baby Aspirin,,,,,"['Chills', 'Dizziness', 'Headache', 'Loss of consciousness', 'Pain']",1,MODERNA,SYR 916831,AR,50.0,F,"red palms for 1st 30min, fever overnight",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,SEN,,,,,,"['Erythema', 'Pyrexia']",1,MODERNA,IM 916832,,27.0,M,"Day two: Injection site redness/swelling, Headache and nausea, full body-ache, joint pain, dry mouth, dehydration, chills/night sweats. Day three: Most symptoms resolved. Only injection site tenderness, redness, elevated reaction site bump, hot to touch and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,MIL,None,None,None,,None,"['Arthralgia', 'Chills', 'Dehydration', 'Dry mouth', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Nausea', 'Night sweats', 'Pain']",1,MODERNA,IM 916833,MD,35.0,F,Mild headache starting about 4 hours after dose. Took Tylenol 500mg PO every 4 hours x three doses. Went away overnight. Came back in the afternoon again for 5-6 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"Vitamin D, Coq 10, magnesium oxide.",None,None,,NKDA,['Headache'],1,PFIZER\BIONTECH,IM 916834,OK,49.0,F,"Onset of moderate arthralgia, injection site pain, and mild myalgia within 9.5 hours of receiving vaccine injection. Onset of severe, activity-limiting arthralgia, myalgia, chills, nausea, and fatigue, as well as 102 F oral temperature, within 22 hours of receipt of vaccine. Symptoms progressively worsened to the point patient suspected influenza infection, so sought testing and evaluation at urgent care facility the evening of 12/31/2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,"Albuterol inhaler PRN, duloxetine 90mg QD, Adderall 90 mg QD, ibuprofen 600mg PRN, acetaminophen PRN (1,000mg PO dose taken 2 hours prior to urgent care visit)",None except history of mild asthma. Patient had positive COVID-19 PCR test on 11/15/2020.,"Mild asthma, uncomplicated; seasonal allergies not requiring medication; attention deficit disorder; depression.",,NKDA,"['Arthralgia', 'Body temperature increased', 'Chest X-ray normal', 'Chills', 'Fatigue', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Injection site pain', 'Myalgia', 'Nausea', 'SARS-CoV-2 test negative', 'Streptococcus test negative']",1,MODERNA,IM 916835,NJ,30.0,F,"Sudden onset cough, shortness of breath, and wheezing. A fever of 100.6 was noted but unsure as to when that occurred as I did not have chills. Feber has subsided. Cough, shortness of breath and intermittent wheezing remain as well as some chest pressure, sore throat, headache and chills. Coughing fits are bad enough to cause urinary incontinence but I did give birth 4 months ago so this may not be significant. No signs of allergic reactive such as redness, urticaria or swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,WRK,Paxil Vyvanse,None,"PTSD, chronic sinusitis, PCOS, idiopathic syncopal episodes",,None known,"['Chest discomfort', 'Chills', 'Cough', 'Dyspnoea', 'Headache', 'Oropharyngeal pain', 'Pyrexia', 'SARS-CoV-2 test', 'Urinary incontinence', 'Wheezing']",1,PFIZER\BIONTECH,IM 916836,MD,55.0,M,"Patient is a 55 year old male with no past medical history who presents with complaint of sudden onset of left-sided nonradiating chest discomfort of sudden onset approximately 1 hour prior to presentation while doing administrative work at rest. He describes the pain as a dull heaviness sensation and approximate 3/10 pain severity. Chest discomfort was associated with a feeling of flushing that was quite transient but chest discomfort was persistent. Patient immediately presented to the ED for further evaluation. He denies experiencing any chest pain upon waking up this morning. Does note that he did have a transient episode of epistaxis on his way to work for which he had to pull over and apply pressure to his nose but this subsequently subsided and he attributed this to dry air as he has experienced epistaxis in the past but with less severity previously. In the ER, vital signs noted for BP 133/76, pulse ranging 91-114, respiratory rate 16-20, 96% on room air. Initial laboratory parameters were completely normal including normal CBC, CMP, LFT, lipase, UA, and normal D-dimer. Initial troponin was negative x1. EKG with sinus tachycardia, heart rate of 115. Noted Q waves inferiorly. No acute ST or T wave changes appreciated. Chest x-ray with mild increased density in the left lower lobe. Given this, patient was tested for rapid Covid which was negative but PCR was positive for COVID. CT of the chest noted for focal subsegmental groundglass infiltrate at the superior segment of the LLL, likely infectious versus inflammatory. Also noted small nonspecific groundglass attenuation with focal septal thickening at the right upper lobe which could be infectious or inflammatory, bibasilar atelectasis. Patient was treated with aspirin 324 mg in the ED. Of note, patient actually just received the COVID-19 vaccination on 12/24/20. He denies any shortness of breath, no cough, denies any nausea or vomiting, denies any change in taste or smell nor change in appetite. Does note 1 single episode of loose stool but otherwise denies any diarrhea. Does report that he had approximate 48 to 72-hour period of fatigue and soreness at the site of the left deltoid injection following the vaccination but otherwise no further symptoms. It is also noted that he does have a positive family history of coronary artery disease as his dad had an MI at the age of 49. Patient has never undergone a cardiac catheterization in the past but does report having a negative stress test at the age of 42. He is being admitted under the hospitalist service for further management Patient was initially admitted under observation for chest pain obs. However patient's Covid test came back positive and patient also had dynamic EKG changes concerning for possible unstable angina. Patient was treated with aspirin Plavix full-strength Lovenox along with beta-blocker and a cardiology consult. Serial troponins were negative. Echocardiogram revealed normal EF of 55 to 60% with no hemodynamically significant valvular disease. Cardiology felt that patient likely has underlying coronary artery disease have recommended discharge home with aspirin and Plavix with outpatient stress testing given his positive Covid testing. At the time of discharge patient denied any chest pain or shortness of breath. Patient was borderline diabetic with a hemoglobin A1c of 6.1. Patient was discharged home with Metformin along with glucometer, glucose strip, lancets. Given patient's tachycardia patient's Metformin 25 mg twice daily was changed to Toprol 25 mg daily. (Please note clarification in comparison to discharge home med list. Toprol XL 25 mg daily was called to pharmacy in place of the metoprolol.)",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/24/2020,12/30/2020,6.0,PVT,No current medications,Pt reported frequent urination for several months,None,,No known allergies,"['Chest X-ray abnormal', 'Chest discomfort', 'Computerised tomogram thorax abnormal', 'Coronary artery disease', 'Diarrhoea', 'Discomfort', 'Echocardiogram normal', 'Ejection fraction normal', 'Electrocardiogram Q wave abnormal', 'Electrocardiogram abnormal', 'Electrocardiogram change', 'Epistaxis', 'Fatigue', 'Fibrin D dimer normal', 'Flushing', 'Full blood count normal', 'Glucose tolerance impaired', 'Glycosylated haemoglobin increased', 'Injection site pain', 'Lipase normal', 'Liver function test normal', 'Lung opacity', 'Metabolic function test normal', 'SARS-CoV-2 test negative', 'SARS-CoV-2 test positive', 'Sinus tachycardia', 'Troponin normal', 'Urine analysis normal']",1,MODERNA,IM 916837,,34.0,F,"I received the vaccine at 10:30 am. About two hours later I noticed a minor headache. By 4pm I had a moderate pounding headache. Around 4:30pm, I noticed minor unilateral scalp, facial and neck numbness on the left side. These symptoms lasted about a week, but slowly improved. Four days after the vaccine I had very tender lymph nodes on the left ear area. Today marks two weeks exactly since I received the vaccine and two days ago I noticed slight increase in numbness on the left cheek again which again, is slowly improving. However, I also wear Invisalign at sometimes notice that I bite my cheek while asleep. I also wear N95 masks four days of the week which are quite tight on the face. The injection site (Left deltoid) was moderately sore for the first few days and still two weeks later has minor soreness the comes and goes.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/18/2020,0.0,WRK,Nortiptyline 10 mg 3 capsules po daily Buspirone 5 mg po twice a day Magnesium Glycinate 400mg/day Plexus Nerve 2 capsules/day Plexus ProBio5 2 capsules /day Plexus Balance 2 capsules/day Plexus VitalBiome 1 capsule/day,,Anxiety Visceral Hypersensitivity Syndrome,,Latex - rash Amoxicillin - rash Bacitracin - rash Codeine - rash,"['Full blood count', 'Headache', 'Hypoaesthesia', 'Injection site pain', 'Lymph node pain', 'Metabolic function test']",1,PFIZER\BIONTECH,IM 916838,WI,57.0,F,"sore arm started same day as vaccine 12/28/2020, then about 12 hours later-history of chronic cough but persistent cough, chills, headache, nausea and dry heaves,. Went to ED on 12/30/2020 at 5 am. given IV fluids, zofran, reglan, fentanyl, morphine. Sent home with prescription for Zofran",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,"B12, Vit D, Calcium, Zinc. Atorvastatin, Valsartan, Prednisone, Metoprolol, Spironolactone, Folic Acid, Fosamax",none,"Dysphagia, CMT (nerve disease), hypertension, hyperlipidemia, osteopenia, melanoma-right leg taken out Aug 2020.",,"Naproxen, Tape","['Amylase', 'Chills', 'Cough', 'Full blood count', 'Headache', 'Metabolic function test', 'Nausea', 'Pain in extremity', 'Retching', 'SARS-CoV-2 test', 'Urine analysis']",1,MODERNA,IM 916839,NM,44.0,F,"Pleuritic chest pain, seen in ED, 12/31/2020, had elevated ddimer, CT negative for PE, EKG and troponin normal, Covid swab negative, diagnosed with pleurisy",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/29/2020,8.0,WRK,Topomax,None,Migraines,,None,"['Chest X-ray normal', 'Computerised tomogram thorax normal', 'Electrocardiogram normal', 'Fibrin D dimer increased', 'Full blood count normal', 'Laboratory test normal', 'Pleurisy', 'Pleuritic pain', 'SARS-CoV-2 test negative', 'Troponin normal']",1,PFIZER\BIONTECH,SYR 916840,TX,32.0,F,"Fatigue, headaches, muscle aches with 12 hours. Low grade fever began 20 hours after vaccination. All symptoms subsided after 48 hours. Bruise-like tenderness at the injection site lasted >72 hours and burning sensation around the posterior of my left arm persisted for >72 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,UNK,Melatonin,None,Crohn's disease,,Dilaudid,"['Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 916841,TX,42.0,M,"Palpitations increased drastically, I started increasing at 01:00 1/1/2021 and at it worse by 07:00 1/1/21 I was having about 1 very 3-5 seconds. I normally take metoprolol ER 50 to control them but I increased the dose to 75 mg and it helped where I was getting one per min or so. I did have a caffeinated drink at approximately 1800 12/31/20 but that?s not new for me.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,"Metoprolol, toperamate, ambien, omeprazole, Imitrex, melatonin, advair, albuterol","Palpitations nos well controlled for years, broncho-spasms recent, migraines",See above,,Amoxicillin,"['Condition aggravated', 'Palpitations']",1,MODERNA,IM 916842,NJ,29.0,F,"Fever, chills, body aches. Swelling at site for 2+ days. Lymph node swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,"estrogen, progesterone, propranalol, protonix, zinc",,Neuroblastoma in 1995 with autologous BMT and total body radiation in remission since 1996,,"ativan, ceftazidime","['Chills', 'Injection site swelling', 'Lymphadenopathy', 'Pain', 'Pyrexia']",1,MODERNA,IM 916844,FL,55.0,F,"Apart from a very sore arm about 24 hours after the vaccine I developed a rash, small red dots. I felt itching all over my body and my face and neck felt like there were sunburnt. I did not lose any work time",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,UNK,Sertraline and Qvar inhayler,none,asthma- mild,,"Penicillin, sulfa, vancomycin, erythromycin, nickel","['Burning sensation', 'Injection site erythema', 'Injection site rash', 'Limb discomfort', 'Pruritus']",1,MODERNA,IM 916845,AR,24.0,F,dizzy / headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,SEN,,,,,,"['Dizziness', 'Headache']",1,MODERNA,IM 916846,AR,36.0,F,"Red face and neck, itching, felt extreme heat sensation, nausea, high blood pressure, chills, muscle spasms to left leg, and headache. Took Benadyrl. Side effects have resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,SEN,None,None,"COPD, Autoimmune disease, fibromyalgia",,anesthesia,"['Chills', 'Erythema', 'Feeling hot', 'Headache', 'Hypertension', 'Muscle spasms', 'Nausea', 'Pruritus']",1,MODERNA,IM 916848,AR,34.0,F,"approx. 6 hours post shot felt like throat was tight, lips were numb and tingly and fingers numb. was given Benadryl orally and symptoms improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,SEN,,,,,,"['Hypoaesthesia oral', 'Paraesthesia', 'Paraesthesia oral', 'Throat tightness']",1,MODERNA,IM 916849,NC,33.0,F,"I received the vaccine in the left arm on 12/23 with no immediate symptoms. On 12/24 I had body aches mostly on my left side. On 12/25, I started having a strong headache, focused mostly on the left side. On 12/26 the headache continued and I also noticed swollen lymph nodes on both sides of my neck, and behind my ears. Also, it felt like someone had broken my nose and when I would try to bite down or chew I would have a sharp pain and pressure in my nose and sinuses. On 12/27, the headache continued, and I had severe left eye pain, as well as pain chewing and the swollen nodes, that became painful to touch. On 12/28, I went to my PCP and was tested for covid, which was negative. She diagnosed me with a sinus infection and prescribed amoxicillin. On 12/29, I noticed my scalp had lumps on it that were painful and I had a very itchy spot on my forehead, which became swollen as well to about a quarter size lump. I also had other painful spots on my scalp all over and a continued severe headache and left eye pain. I tried to follow up with my PCP on 12/31, but their office was closed, and the on call nurse referred me to urgent care. More painful, swollen lymph nodes have appeared on my face and neck. I wasn't able to be seen at urgent care until today (1/1), and was then diagnosed with Shingles. I was told to continue amoxicillin and to start taking Valtrex. I am very itchy, mostly on my face, scalp, and left side of my body.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,mirena,none,none,,none,"['Eye pain', 'Headache', 'Herpes zoster', 'Lymph node pain', 'Lymphadenopathy', 'Pain', 'Pain of skin', 'Paranasal sinus discomfort', 'Pruritus', 'SARS-CoV-2 test negative', 'Sinusitis']",1,PFIZER\BIONTECH,IM 916851,IL,41.0,F,Moderate to severe nausea for the past 6 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/26/2020,4.0,WRK,"Aplenzin 522mg, Flonase Sensimist, Clonazepam 0.5mg BID PRN, Melatonin SR 0.2mg, Ambien CR 12.5mg, Tretinoin cream, Elidel topical, Hydroquinone topical, Multivitamin and Krill oil supplements.","Allergic Rhinitis, Exercise-induced Asthma, Anxiety, Depression, Delayed Sleep Phase Disorder, Rosacea and Osteoporosis.","Allergic Rhinitis, Anxiety, Depression and Delayed Sleep Phase Disorder.",,No allergies to medications or food. Only perennial allergies related to Allergic Rhinitis.,['Nausea'],1,PFIZER\BIONTECH,IM 916852,OH,69.0,F,"severe chills, headache, low grade fever, joint pain, nausea and vomiting, and injection site soreness Onset was within <5 hours of injection and lasted 60 hours. Took Tylenol for fever which helped control that symptom. It was like hospitalized COVIC all over again. Reluctant to receive 2nd dose if I have this same adverse reaction. I had donated my COVID convalescent plasma that morning for the 4th occasion but I was told it would not interfere with the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Gemfibrosil, Excedrin extra strength, multivitamin",none,headaches,"Shingles shot: arm was hot, red, swollen and tender, age 65 brand UNKNOWN, approx 5 years ago in the summer","pencillin, garlic, aspertane products, root beer, red wine, shrimp","['Arthralgia', 'Chills', 'Headache', 'Injection site pain', 'Nausea', 'Pyrexia', 'Vomiting']",UNK,MODERNA,SYR 916853,,73.0,M,"Moderna COVID-19 Vaccine EUA Lightheadedness, similar to effect of one or two alcoholic drinks. Systolic BP 180. No typical symptoms nor signs of allergy. No treatment except to watch and wait. Systolic BP returned to normal (<150) in 15 minutes. Lightheadedness fully resolved in less than 2 hours..",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"rosuvastatin, gabapentin, duloxetine, tamsulosin, baby aspirin (1/day), multivitamin; insulin to control diabetes (see item 12)",none,"diabetes (type 1) since 1969,",,sulfa,"['Blood pressure systolic abnormal', 'Dizziness']",1,MODERNA,IM 916854,CA,61.0,F,12/28 developed shingles for the first time. Started antivirals 12/31when vesicles appeared and I realized it was shingles.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/28/2020,8.0,PVT,none,none,obesity high cholesterol,,none,"['Blister', 'Herpes zoster']",UNK,PFIZER\BIONTECH,IM 916856,NY,56.0,F,"Approximately one hour after receiving the vaccine, I noticed slight heart palpitations, very occasional and mild. I had not experienced these before. No very worrisome, but noticeable. They occurred approximately four times a day. They occurred while I was sitting. I did not have any issues with exercise. They increased one week later. On 12/30/20 I was seen at urgent care for an EKG, bloodwork, etc. Although the EKG was normal, the physician and nurse were able to detect preventricular contractions on the heart monitor. My blood pressure was very elevated.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,WRK,Vitamin D Omega 3 fish oil,none,none,,none known,"['Blood pressure increased', 'Blood test', 'Chest X-ray', 'Electrocardiogram normal', 'Palpitations', 'Ventricular extrasystoles']",1,MODERNA,IM 916857,CO,65.0,M,"Moderna COVID-19 Vaccine EUA- Received vaccine on 12-30-20, 10:30 AM. Woke up on 12-31-20, at approximately 2:30 AM, with cold chills, headache, and muscle/joint aches. The symptoms lasted until 01-01-21, at approximately 9:30 AM. The headache persisted longer than the other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,"Medications: Atorvastatin (40mg) Supplements/Vitamins: Centrum Silver Daily (Men 50+), Cranberry Tablets (4200mg x 4), CoQ10 (100mg x 1), Vitamin D3 (50mcg x 1), Bayer Low Dose Aspirin (81 mg x 1), AREDS 2 Eye Vitamins (x2), Elderberr",None,High Cholesterol,,None,"['Arthralgia', 'Chills', 'Headache', 'Myalgia']",1,MODERNA,IM 916858,NE,29.0,M,I have had headaches on and off for a couple of days since I got the vaccine. I took some tylenol which would help a little bit and then return,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PHM,,,,,,['Headache'],1,MODERNA,IM 916859,RI,37.0,F,"The vaccine was received at 1:12 PM, and I felt fairly fine, aside from injection site pain and some tingling in my left arm until I had sudden significant elevation of heart rate, with shortness of breath, and throat swelling/tightening at approximately 1:26PM. I cold compress was applied to my forehead and I was put in a reclining position & then received Epinephrine at 1:28PM. EMS (present onsite) arrived for transport at 1:31PM. 4L of oxygen was applied after O2 sat of 89% noted by EMS. Blood pressure was elevated to >200/100 initially by EMS. Symptoms improved quickly following epinephrine, with some residual feelings of very mild throat fullness, and I developed chills which improved over time. I was transported to emergency department where I was evaluated (symptoms mostly resolved at that time, but ED physician noted a little swelling remaining in my uvula), then IV Benadryl and Decadron were given. Later acetaminophen was also given for headache that developed during my ED stay. My vitals were monitored throughout and observation occurred until I was discharged at approximately 5:00PM, as symptoms had not recurred.",Not Reported,,Yes,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,"fexofenadine, famotidine, hydroxychloroquine,",None,"Undifferentiated connective tissue disorder, asthma, seasonal allergies, Raynaud's phenomenon, GERD, migraine",,"peanuts, soy, oysters, crab/lobster, penicillin","['Blood pressure increased', 'Chills', 'Dyspnoea', 'Enlarged uvula', 'Headache', 'Heart rate increased', 'Injection site pain', 'Paraesthesia', 'Pharyngeal swelling', 'Throat tightness']",1,MODERNA,IM 916861,OR,51.0,F,"continuing injection site redness, swelling, heat, mild tenderness, itching > 7days post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/26/2020,3.0,PVT,"prempro, fluoxetine, zyrtec",none,none,,none,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 916862,GA,44.0,F,"Rash from L arm, up to neck and down back, palpitations and dizziness within5 minutes of receiving vaccine, elevated Bp. Treated with benadryl25mg oral. Symptoms returned within 45 minutes. Received another 25mg benadryl orally plus 40mg pepcid. Symptoms mostly resolved after that. Rash flared up again 4hours later. 25mg benadryl orally administered at home. Rash was present the next morning but resolved with no treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Allopurinol Corey Vitamin D3 Magnesium.,None,"HTN, gout, MVP",,ARB- angioedema (mild),"['Blood pressure increased', 'Dizziness', 'Palpitations', 'Rash']",1,PFIZER\BIONTECH,IM 916863,MD,56.0,F,"patient had dizziness, headache and nausea. bp was 127/89 HR 87. Patient was evaluated by a doctor that was working vaccination clinic. instructed to take tylenol. No further intervention required.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Dizziness', 'Headache', 'Nausea']",1,PFIZER\BIONTECH,IM 916864,OH,28.0,F,"Local pain, temperature 100.2, child, nausea, headache, body aches, lightheaded for about 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,UNK,"Ovasitol, NAC, vitamin d",None,PCOS,,Penicillin Sulfa,"['Body temperature increased', 'Dizziness', 'Headache', 'Nausea', 'Pain']",1,MODERNA,IM 916865,TX,57.0,F,Shortness of breath and body aches at 0324 am at ER,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,None,Finished physical therapy Dec 8th for shoulder and back pain,None,,None,"['Chest X-ray', 'Dyspnoea', 'Pain']",1,MODERNA,SYR 916866,PR,28.0,F,Initial dose placed 12/23/20. On 12/31 (one day after placing Emgality shot for migraines) red circle on vaccine site injection and rash (inflamed mosquito-like bites) on left leg and right butt cheek. Took Benadryl. Rash on leg and butt cheek disappeared after a few hours. Reddish ring around injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,PUB,Birth control Emgality (monthly preventative migraine shot),None,Polycystic ovaries Migraines,,None,"['Injection site erythema', 'Rash']",1,MODERNA,IM 916867,NC,44.0,F,"itching & rash (both arms & chest) started 10 minutes after injection; treated by paramedics on site with benadryl 25 mg po; VS monitored for approx 15 minutes- remained normal, slightly elevated temp, lungs sounds clear, hot flashes throughout afternoon. About 45 minutes after injection took 1000 mg tylenol and 800 mg ibuprofen. additional 50 mg benadryl and 800 ibuprofen at bedtime for continued rash & itching. Next day symptoms still present, but minor. injection site became red, warm, tender to touch with small knot, 8-00mg ibuprofen taken in the morning and then 50 mg benadryl & 800 mg ibuprofen taken at bedtime. Day 3, slight itching, faint rash remains, injection site remains red, warm, tender to touch with small knot,",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,WRK,"metformin, pepcid",none,pre-diabetes. GERD,"MMR- severe facial pain, 3/2015",PPD serum (aplisol),"['Body temperature increased', 'Hot flush', 'Injection site erythema', 'Injection site nodule', 'Injection site pain', 'Injection site warmth', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 916868,WV,58.0,M,Priapism lasting 90 minutes,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/15/2020,12/16/2020,1.0,PVT,Not applicable,None,Not applicable,,None,['Priapism'],1,PFIZER\BIONTECH,IM 916869,WV,72.0,F,"3 hours after receiving injection, I had severe diarrhea. Into the night I began vomiting (which lasted all night) I became feverish, had chills with body shaking, extreme nausea. (temp 102) This persisted to the next day and I went to the ER. There I was given multiple liters of IV fluids, IV Zofran and IV Tylenol. I felt better after treatment but still had the intense headache and ringing in the ears. The next day, I'm now gradually beginning to feel better, just weak. I can eat today, two days after the injection and slowly beginning to feel better. This reaction was terrible for me.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,Atorvastanin 10 mg once a day Metoprolol 50 mg once a day,NONE,NONE,,sulfa,"['Asthenia', 'Blood test', 'Chills', 'Diarrhoea', 'Headache', 'Nausea', 'Pyrexia', 'Tinnitus', 'Tremor', 'Vomiting', 'White blood cell count increased']",UNK,MODERNA,IM 916870,KY,34.0,F,"On a walk, legs, torso, and buttocks became unbearably itchy. It was about a mile walk and occurred about halfway through, upon arriving home, my entire body was red, skin was bumpy and swollen, and itchy was increasing. It started around 2:50pm and I took an extra dose of Cetirizine 10mg at 3:15pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/01/2021,2.0,PUB,"Birth control, cetirizine, singulair, venlaxefine",None,Allergies,,"Sulfa drugs, shellfish, milk, soy, tree nuts, environmental, latex, metals","['Erythema', 'Pruritus', 'Rash', 'Swelling']",1,MODERNA,SYR 916871,MD,36.0,F,"patient had headache about 20 minutes after vaccination. No further interventions, patient does have a history of migraines.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,['Headache'],1,PFIZER\BIONTECH,IM 916872,AZ,27.0,M,"I got my 1st dose of the Covid-19 Vaccine on Dec. 17th, 2020. On Dec. 28th, 2020 (11 days later), I developed a terrible headache, body aches, stomach aches, and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/28/2020,11.0,OTH,None.,None.,None.,,Not that I know of.,"['Abdominal pain upper', 'Fatigue', 'Headache', 'Pain', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 916873,PR,56.0,F,"Hardening, redness of the vaccine administration area when touching the area is hot and hurts when moving the arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,None,None,Asthma,,Lobsters,"['Injection site erythema', 'Injection site induration', 'Injection site warmth', 'Pain']",1,MODERNA,IM 916874,GA,43.0,F,Day 1: Severe fatigue Day 2: Fatigue and difficulty regulating temperature (chills and sweats) Day 3: Fatigue and minor nasal drainage,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PUB,lisinopril,GI upset - bloating and constipation,hypertension. Previous gastric sleeve surgery,,none,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Paranasal sinus hypersecretion', 'Temperature regulation disorder']",1,PFIZER\BIONTECH,IM 916876,WI,62.0,F,Loss of taste more pronounced than when I had virus 4 months ago,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PVT,Levothyroxine,None,None,,No,['Ageusia'],1,PFIZER\BIONTECH,SYR 916877,,21.0,M,"Itchy eyes. Resolved with 25 mg benadryl. Sore arm for three days. Chilly off and on for three days. Still some tired on third day. Does not know if this is related, but an old boil site started bleeding off and on and has not stopped.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PUB,"Lexapro, 20 mg, turmeric, vit B, vit D, elderberry, calcium, magnesium, omega 3, zinc",None,None,,"Omnicef, zithromax, melatonin, soy, wheat, peanut, milk","['Eye pruritus', 'Fatigue', 'Furuncle', 'Haemorrhage', 'Pain in extremity']",1,MODERNA,IM 916878,WA,26.0,F,"roughly an hour + after receiving the shot my whole left side became very sore, to the point where I couldn't turn my neck or rotate my back. It was painful to sit or lay. This lasted roughly 48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Levothyroxine, Hydroxizine, Sertraline, Vitamin D",none,hypothyroidism,,"Amoxicillin, Demerol","['Flank pain', 'Mobility decreased']",1,MODERNA,IM 916879,PA,57.0,F,"After 6 days, my injection site. Hot, itchy, swollen to the size of of a softball. Went to the urgent care and they gave me antibiotics.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/29/2020,6.0,PVT,Prozac. Oxycodone. Saxenda. Rovastatin. Synthroid. Crestor. Lisinapril. Baby aspirin.,None,Back pain high cholesterol. High blood pressure,,None,"['Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",2,MODERNA,SYR 916880,IL,44.0,F,"fevers starting same day (12/29/2020), swelling and redness to injection site (12/30/2020) , woke up today (1/1/2021) with numbness, tingling down L arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,PVT,"quvar, OTC allergy meds",none,"asthma, seasonal allergies",,"cefaclor, levofloxacin, dust","['Hypoaesthesia', 'Injection site erythema', 'Injection site swelling', 'Paraesthesia', 'Pyrexia']",1,MODERNA,IM 916881,IL,34.0,M,"Moderna COVID-19 Vaccine EUA Left sided nerve pain, mid thoracic region posterior and mid-axilary, back of left leg and left lateral foot. Sensitive to light touch. Generalized Body chills and lethargy. Left sided body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,SCH,None,None,None,,None,"['Chills', 'Lethargy', 'Neuralgia', 'Pain', 'Tenderness']",1,MODERNA,IM 916882,NC,36.0,F,"injection site reaction ( large, about 4 inch long red oblong rash, minor itch)",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,PVT,"Propranolol 20mg Qhs, magnesium oxide 250mg bid, melatonin 10mg Qhs",none,migraines,,"cefdinir (hives), compazine (severe restlessness)","['Injection site pruritus', 'Injection site reaction', 'Rash erythematous']",1,MODERNA,IM 916883,MI,86.0,M,"12/29- resident stated to run temp of 100.7 and had nausea 12/30- nausea and vomiting, no temp, complaints of not feeling well 12/31- nausea, 1/1- no further symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,SEN,Amlodipine senna atorvastatin iron Synthroid Tylenol aspirin Lasix daily multiple vitamin gabapentin,"heart disease heart failure kidney disease perforated bowel sepsis type II diabetes PARALYTIC ILEUS ANKYLOSING SPONDYLITIS LUMBAR REGION PNEUMONIA, UNSPECIFIED ORGANISM VENOUS INSUFFICIENCY HYPOTHYROIDISM, DEMENTIA PRESSURE ULCER OF SACRAL REGION CHRONIC OBSTRUCTIVE PULMONARY DISEASE PERSONAL HISTORY OF OTHER VENOUS THROMBOSIS AND EMBOLISM HISTORY OF MALIGNANT NEOPLASM OF PROSTATE",heart disease heart failure kidney disease diabetes mellitus,,lisinopril Levaquin,"['Body temperature increased', 'Malaise', 'Nausea', 'Vomiting']",UNK,MODERNA,IM 916884,ND,52.0,F,"At 7:00 pm on Dec. 31, I began with severe diarrhea. At 9:00 pm I began to feel bloated. By 9:20, I had severe chills that I have never experienced before. By 10:00 I was short of breath, dry heaving, shaking, and severe body pain. Symptoms resolved by 12:00 am. On January 1, I awake with moderate headache and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,None,None,None,,None,"['Abdominal distension', 'Chills', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Headache', 'Pain', 'Retching', 'Tremor']",1,MODERNA,IM 916885,MD,60.0,F,"Patient was discharged at 1:25 came back at 1:36 with itchy rash on forearm, given Benadryl 50mg IM. Assessed by doctor working clinic at 2:15, rash was fading and itching resolved. No breathing or airway issues, was discharged.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Rash', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 916887,VA,69.0,F,Itching of both arms and hands for approximately one hour. No treatment. Fully recovered.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,PVT,None,None,None,,"Sulfa, Codeine, Empirine",['Pruritus'],1,PFIZER\BIONTECH,IM 916888,CO,50.0,F,"Rash with itching, pain left shoulder/arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/31/2020,7.0,PVT,"Buspirone, bupropion, vitamin b complex, calcium, glucosamine, vitamin D",None,None,,None,"['Injection site pain', 'Pain in extremity', 'Rash pruritic']",1,MODERNA,IM 916889,OH,56.0,F,I have a sore throat is this normal,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,WRK,none,I felt like I was starting to get a cold,none,,none,['Oropharyngeal pain'],UNK,MODERNA,SYR 916890,TX,39.0,F,"HIVES, SOB, THROAT CLOSING UP, WHEEZING",Not Reported,,Yes,Yes,4.0,Not Reported,Y,12/01/2020,12/22/2020,21.0,WRK,"Zoloft, vitamin d, vitamin b, zinc, Wellbutrin, singular",None,None until vaccine,,None,"['Chest X-ray', 'Dyspnoea', 'Laboratory test', 'SARS-CoV-2 test', 'Throat tightness', 'Urticaria', 'Wheezing']",1,PFIZER\BIONTECH,IM 916891,IL,26.0,F,"12/28/2020 around 5:30 PM she started getting itchy. Progressing as night went on. On 12/29/2020 around 5-6:00 AM you woke with hives, hoarse voice and eyes swollen. A little SOB with talking. Also had weakness and tingling. Tingling was ""everywhere"".. Went to ER. Treated in the ER and released. Also on this day she had additional reaction to prednisone and she found out she is allergic to this. On 12/31/2020 she had to return to ER. She was at work and not feeling the greatest. Feeling light headed on and off. Continued to work and while driving home felt confused and light headed and called co workers. Felt weak again.. Called co workers who work for ambulance service They came and checked her out and her B/P was high and having PVC's per the heart monitor Transported to ER per the ambulance. 1/1/2021 she is feeling better. Received fluids last night. ER felt it was due to receiving vaccine and then additional allergic reaction to prednisone.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PUB,None,None,None,,At time of immunization was known to be allergic PCN. AS of 1/1/2021 has been told allergic to prednisone.,"['Asthenia', 'Blood pressure increased', 'Confusional state', 'Dizziness', 'Drug hypersensitivity', 'Dysphonia', 'Dyspnoea', 'Eye swelling', 'Hypersensitivity', 'Paraesthesia', 'Pruritus', 'Urticaria', 'Ventricular extrasystoles']",1,MODERNA,IM 916892,,65.0,M,"Two days of feeling chilly and tired, some mild headaches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PUB,"Citalapram, dutasteride, linsinopril/ACTZ, COQ10, omega 3, Aspirin 162 mg, claritin, elderberry, vit D3, vit b12, zinc, rosuvastatin",None,"High blood pressure, high cholesterol,","December 23, 2003, age 48, Itchy skin - Jap Encep, IPV, Hep A #3 10 mg, Hep A#1 1440 E.L.u, Typhoid Vi. Treated with benadryl in",,"['Chills', 'Fatigue', 'Headache']",1,MODERNA,IM 916894,UT,56.0,F,very sore arm at injection site for 2 days; moderately sore on 3rd day,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,UNK,Omeprazole 20 mg,,,,Penicillin,['Injection site pain'],1,MODERNA,IM 916895,MI,27.0,F,shoulder redness/itching/warmth starting 7 days after injection. Advised to use warm compress/Tylenol/Benadryl. Advised f/u in UC or ED for any new/worsening symptoms of any kind,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/31/2020,8.0,PVT,"albuterol HFA (PROAIR HFA ; PROVENTIL HFA ; VENTOLIN HFA) 90 mcg/actuation inhaler Inhale 2 puffs every 4 (four) hours if needed for wheezing or shortness of breath. ? desogestreL-ethinyl estradioL (APRI,ENSKYCE,EMOQUETTE,ISIBLOOM,JULEBER,K","evaluated on 12/28 for uURI symptoms, had negative COVID PCR screening test",asthma/depression/anxiety/migraines,,Penicillin/amoxicillin Sulfa Grass pollen,"['Erythema', 'Pruritus', 'Respiratory symptom', 'SARS-CoV-2 test negative', 'Skin warm']",1,PFIZER\BIONTECH,IM 916896,MD,43.0,F,"Mild tingling of the right upper lip, no swelling no respiratory issues. Tingling resolved at 9:53am and the patient was discharged to home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,ibprophen. facial and hand swelling,['Paraesthesia oral'],1,PFIZER\BIONTECH,IM 916897,AZ,48.0,F,"After monitoring for 15 min post-vaccination, I drove away. On the 17th minute, my face got hot, then I headache started. A minute later fatigue hit and I was starting to fall asleep at the wheel. I live 1 mile away so I made it home. Now my head was getting fuzzy. Called a co-worker to tell her what was happening and she said my speech was slurring. I felt drunk and hungover at the same time. I went to bed and slept for an hour. I woke up and felt very fatigued. I finally went to bed for the night then was awoken with severe arm pain. My entire upper arm felt so tight but I it was soft upon palpation. I fell asleep and awoke to terrible arm pain again. I started crying in bed but fell asleep again. I woke up in the morning with severe upper arm pain and minor headache. I couldn't rotate my arm back to put my bra on so I took some ibuprofen. That had immediate relief for my arm and headache. I ran one errand and was wiped out. The fatigue hit again. The arm pain came back so I took another ibuprofen with relief. I had no energy so laid around for the rest of the day. I woke up on Sunday and finally felt normal with just pain at the injection site. The 2 other medical people that have had similar reactions like mine with dizziness and feeling light-headed have one thing in common with me...we are all vegetarians. I don't know if that makes a difference with protein metabolism or other enzymatic activity, but we are the only 3 that I know of out of all of our co-workers who have received the vaccine to react like this.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,OTH,"Iron, Vitamin C",Head cold the day after Thanksgiving for 2 days. Headache and sore throat. Gone after 2 days.,None,,NKA,"['Asthenia', 'Crying', 'Dysarthria', 'Fatigue', 'Feeling abnormal', 'Feeling drunk', 'Feeling hot', 'Hangover', 'Headache', 'Injection site pain', 'Mobility decreased', 'Muscle tightness', 'Pain in extremity', 'Sleep disorder', 'Somnolence']",1,PFIZER\BIONTECH,IM 916898,FL,71.0,M,"MODERNA COVID-19 VACCINE EUA GENERAL SIDE EFFECTS: FATIGUE, HEADACHE, MUSCLE PAIN, JOINT PAIN, CHILLS.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,UNK,Lipitor 20 mg Metatropil Nexlizet Alfuzosin,None,None,,No,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia']",UNK,MODERNA,SYR 916899,SC,46.0,F,"Body aches, chills, headache, nausea within 16-24 after receiving vaccine. All symptoms resolved within 48 hours after receiving the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,Levothyroxine,None,Hypothyroidism,,None,"['Chills', 'Headache', 'Nausea', 'Pain']",1,MODERNA,IM 916900,CT,36.0,F,"At approximately 15 minutes post vaccine patient reported left hand numbness/tingling. At about 30 minutes patient reported lip tingling, given 25 mg benadryl. Shortly progressed to ""heart pounding"" and progressing ""facial tingling and throat tightening"". Epipen 0.3mg administered and EMS called. Pt reported feeling much better within 2-3 minutes of epi pen. Transported to Hospital for further care.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Hypoaesthesia', 'Palpitations', 'Paraesthesia', 'Paraesthesia oral', 'Throat tightness']",UNK,MODERNA,IM 916901,OH,23.0,F,"10am, shot was administered. 9pm pain in my arm started. 10pm pain became worse and arm began to swell. 11pm body aches began and fever of 100.6, 12am chills began, 1am, headache (mild). Throughout the night I had fevers ranging between 101 and 102.4 I sat at 101.7 for a few hours (without the use of Tylenol). Got up for work by 9am. Did not sleep at all through the night. Body hurt a lot, fever of 100.7, arm is hard, hot, and red. Spot around injection site is growing. Took too Tylenol around 10am to make it possible for me to work. Chills became mild and temp dropped to 99.6 for most of the time I was taking Tylenol. 24 hours after the symptoms started they went from severe to moderate (without the use of Tylenol). Was able to sleep last night. No chills but still had a low fever 100.6 woke up today and my body hurts. Temp was 99.3 at 10am. By 4pm 2 days after getting the vaccine my are is still very hot to the touch, red, and hard. It does not look better. Back to normal temp 96.6 and body hurts in the mild range.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,Focalin Iron B12 Buspar,None,None,"Low fever usually around 100-100.4, some swelling in arm, and mild body aches",None,"['Chills', 'Erythema', 'Headache', 'Induration', 'Injection site reaction', 'Insomnia', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Skin warm']",1,MODERNA,SYR 916902,GA,44.0,F,"I Woke up about 36 hours post vaccine administration with swelling and tenderness mainly under my left eye. I have a previous history of fillers in my tear trough areas and cheeks, last filler injection was January 2020. I have some swelling under the right eye too. I have read about that being caused by an immune reaction to the filler after vaccine administration. I have not treated the swelling , as I want to see how long it persists.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,Hctz Metoprolol Lexapro,No,Hypertension,,None,"['Swelling face', 'Tenderness']",1,MODERNA, 916903,TN,54.0,M,Tightness of chest hard to breathe. Given two shots of morphine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PUB,,None,,,Stadol,"['Blood test', 'Chest discomfort', 'Dyspnoea', 'Electrocardiogram']",1,MODERNA,SYR 916904,CA,49.0,M,"Pt. symptoms included: swelling in the eyes, chest tightness, lump in throat, tachycardia, hypertension, and wheezes. Pt. was treated on scene with .5mg of epinephrine (IM) and albuterol inhaler in route to hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,WRK,,None,Recently (1-2 years ago) diagnosed with exercise induced asthma.,,"Allergies to bees, shellfish and shrimp.","['Chest discomfort', 'Eye swelling', 'Hypertension', 'Sensation of foreign body', 'Tachycardia', 'Wheezing']",1,MODERNA,IM 916905,FL,45.0,F,"Dizziness starting around 4am on 12/31/20. Progressed into body aches, chills, severe headache and fever of 101.9 degrees over the course of the morning. I sweat through 3 layers of clothing during the night. Now on 1/1/21 at 4pm I am still achey, especially in my legs. I feel weak and my temperature has come down to 100.4.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,UNK,,,,,,"['Asthenia', 'Chills', 'Dizziness', 'Headache', 'Hyperhidrosis', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 916906,MD,31.0,F,Associate has history of asthma was planned to be observed for 30 minutes. at 12:30 patient complained of light headache which fully resolved after 30 minutes. no further intervention.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,ashtma planned,,,['Headache'],1,PFIZER\BIONTECH,IM 916907,NE,40.0,M,"Breathing difficulty-treated with nebulized medication. Received some relief after breathing treatment. I am on day 2 of having to take breathing treatments. Had fever as high as 102 degrees. I have been sweating profusely for 3 days. I had one night of hallucinating dreams and hardly slept at all. I had all of the general side effects, fatigue, headache, muscle pain, joint pain, chills. I had a rapid heartbeat.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Symbicort, levo-certrizine, montelukast, sertraline,",,Asthma,,,"['Abnormal dreams', 'Arthralgia', 'Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Heart rate increased', 'Hyperhidrosis', 'Insomnia', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 916908,CA,37.0,M,12/30/20 at 7am as soon as I woke up I was in sever pain and had fever and chills. I was not able to leave the bed at all the day unless to use the bathroom to which I would be out of breath from that. I slept most of the day as I was so very weak. This lasted all that day. On 12/31/20 I was still weak and tired but able to get out of bed with bad headaches and pain in my bones all over. I would still loose my breath walking anywhere in my home. Sharp pains would come and go throughout the day at least once and hour if not more. Sleeping was next to impossible due to the pain. On 1/1/21 which is my current day my headaches are still here along with slight pain and weakness. I can breath better but the injection site on my left arm is still sore but not as bad as the last few days where it was on fire and very sensitive.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,WRK,Gabapentin,COVID 19 Positive on 12/11/2020,"Sleep Apnea, I have a CPAP Machine",,None,"['Asthenia', 'Bone pain', 'Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Hypersomnia', 'Injection site pain', 'Pain', 'Pyrexia', 'Sleep disorder']",UNK,MODERNA,IM 916909,AZ,58.0,F,I had the chills during the night and a severe headache. My left arm pit(axilla )is tender and sore .,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PUB,"zinc, b12, vitD",none,none,,codeine gives me a headache and morpine many years ago gave a mild rash,"['Chills', 'Headache', 'Pain in extremity', 'Tenderness']",1,MODERNA,IM 916910,MT,73.0,F,"Patient called and left voicemail she woke up during the night after her first COVID-19 Moderna vaccine with rapid heart rate 130bpm and high blood pressue, but did not elaborate what high blood pressure was. Said after that she has felt fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PUB,unknown at this time,None,unknown at this time,,None,"['Heart rate increased', 'Hypertension', 'Sleep disorder']",1,MODERNA,IM 916911,CA,43.0,F,severe upper back pain with increase in pain with movement of my neck radiating between shoulders pain in the upper thoracic with walkiing and raising arms tingling in the upper back bl,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,PVT,synthroid,none,hypo IgA MGUS grave's disease- s/p thyroidectomy,,none,"['Back pain', 'Chest pain', 'Neck pain', 'Pain', 'Paraesthesia']",1,MODERNA,IM 916912,NJ,29.0,F,"Fatigue, joint pain, muscle aches, stabbing headaches, redness and swelling at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,Multivitamin Vitamin E Vitamin C Melatonin,,,,Gluten Dairy,"['Arthralgia', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site swelling', 'Myalgia']",1,PFIZER\BIONTECH,IM 916913,NY,35.0,M,"Hives on arms, legs, torso.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/24/2020,3.0,UNK,Truvada,None,None,,None,['Urticaria'],1,PFIZER\BIONTECH,IM 916914,MA,27.0,F,"Moderna COVID-19 Vaccine EUA I had severe chills, bodyaches, headache and fever approximately 20 hours after receiving the vaccine. The chills, rigors and teeth chatter were the worst of my symptoms. All symptoms lasted about 18 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,UNK,,,,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 916915,,49.0,F,"mild dizziness (at time of injection); injection site soreness (12 hours after injection; duration 1 day); 3 says after injection: nausea, dizziness and weakness, headache, tiredness, feeling unwell.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/31/2020,3.0,UNK,Arnuity Elipta; Flonase; Pristique; Allegra; iron supplement; multi vitamin; vitamin D supplement,none,asthma; environmental allergies,,penicillin; betadyne; cow-dairy intolerance,"['Asthenia', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Nausea']",1,PFIZER\BIONTECH,IM 916917,PA,23.0,F,Headache a few hours after injection and now it is 01/01/2021 and I still have a headache. Some nausea and overall generally feeling run-down and unwell. Also bad pain in my arm from site of injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,Ritual Multivitamin,N/a,N/a,,N/a,"['Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Nausea']",UNK,PFIZER\BIONTECH,SYR 916918,WI,0.33,M,Slight fever the day of the injections. The next night he Stopped breathing in the middle of the night twice. Temperature was 96 degrees Fahrenheit when arriving at the emergency room.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/29/2020,12/31/2020,2.0,PVT,None,Cough,None,,None,"['Ammonia', 'Apnoea', 'Blood lactic acid', 'Blood test', 'Body temperature decreased', 'Bordetella test', 'C-reactive protein', 'Chest X-ray', 'Electrocardiogram', 'Influenza virus test', 'Pyrexia', 'Respiratory syncytial virus test', 'SARS-CoV-2 test']",2,UNKNOWN MANUFACTURER, 916919,,,U,"Severe headache, flu like symptoms and fatigue the day after the vacinne. Followed by muscle aches and low grade fever for several days. Slowly started feeling better without a fever. 7 days after vacinne I begin feeling flu like symptoms with a 102 and 103 fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Echocardiogram normal', 'Electrocardiogram normal', 'Fatigue', 'Headache', 'Influenza like illness', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 916920,VT,28.0,F,"Headsache,vertigo, and nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,07/10/1992,12/29/2020,10399.0,PVT,Levothyroxine,non e,hypothyroidism,,nka,"['Headache', 'Nausea', 'Vertigo']",1,MODERNA,IM 916921,FL,61.0,M,"Previous Covid + physician with documented antibodies Symptoms started 17 hours post vaccine Fever x 36 hours Chills Rigors Malaise Myalgia Mild diarrhea, anorexia,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,Rosuvastatin Metoprolol Modafinil,None,"HTN Hyperlipidemia OSA Covid infection requiring hospitalization July 30, 2020",,Food allergy to oyster and crab,"['Chills', 'Decreased appetite', 'Diarrhoea', 'Malaise', 'Myalgia']",1,MODERNA,IM 916924,OH,49.0,F,"Initial injection, Dec 23rd, I had burning sensation for 3-5 minutes at which time it subsided. Approx 3 hrs later my arm was achy, stiff ( especially went not moving) and sore for 3days or so. On Jan 1, I noticed a large red, warm area on my deltoid in the area of injection site. At this point arm is feeling a bit sore",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/01/2021,9.0,PVT,SMART daily women's vitamin Benadryl (taken precautionary prior to vax) Primrose supplement daily,Blepharitis of left eye,,,Multiple allergies to antibiotics,"['Burning sensation', 'Injection site erythema', 'Injection site warmth', 'Limb discomfort', 'Musculoskeletal stiffness']",1,MODERNA,SYR 916925,PA,48.0,F,Aches Chills Large area redness warmth biceps,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/27/2020,1.0,PVT,Pantoprazole Claritin Clobetasol,None,None,,Sulfa antibiotics,"['Chills', 'Injection site erythema', 'Injection site warmth', 'Pain']",1,MODERNA,SYR 916927,IA,39.0,F,"Fever up to 99.5, severe headache, severe nausea at times, dizziness, bilateral ear pain, fatigue, muscle aches in thighs, joint pain in hips, knees and hands, some congestion. Have had symptoms for past 36hrs and continue. I believe they are starting to lessen. Have been taking Tylenol, ibuprofen and Mucinex D around the clock since the day of getting vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PUB,Zoloft 50mg Prilosec 20mg Allegra 180mg Multivitamin,"COVID positive 12/4/20. Symptoms lasted approx 8-9 days before improving. Included low back pain, HA, nausea/dizziness, fatigue, body aches, fever, congestion, lost of taste and smell. Continues lingering intermittent headaches and fatigue from Covid 19.",Anxiety/Depression Suffers from intermittent headaches GERD Seasonal Allergies,"TDap, general mailase for a day both times I've had the vaccine. Never reported. Not sure on dates. Some times the flu vaccine",Seasonal Allergies Sensitivity to Azithromycin-vomit,"['Arthralgia', 'Dizziness', 'Ear pain', 'Fatigue', 'Headache', 'Myalgia', 'Nasal congestion', 'Nausea', 'Pyrexia']",1,MODERNA,SYR 916928,MD,66.0,F,"patient developed red papules on arm. no itching, swelling or respiratory symptoms. instructed to monitor and take benadryl 25mg prn. (Patient left vac clinic with no reaction and came back next day to report rash.)",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,PVT,patient is taking blood thinner,,,,,['Rash papular'],1,PFIZER\BIONTECH,IM 916929,FL,93.0,F,"Resident with physical decline prior to vaccination. Noted with fever, t. 100.6 after 24 hours, and t. 99.2 in 48 hours post vaccine with increasing physical decline with confusion. Sent to hospital for evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,SEN,"hydrALAZINE HCl Tablet 50 MG Give 1 tablet by mouth two times a day for HTN related to ESSENTIAL (PRIMARY) HYPERTENSION (I10) Pravastatin Sodium Tablet 10 MG Give 1 tablet by mouth at bedtime related to HYPERLIPIDEMIA, UNSPECIFIED (E78.5)",Recent physical decline,"S32.010D T WEDGE COMPRESSION FRACTURE OF FIRST LUMBAR VERTEBRA, SUBSEQUENT ENCOUNTER FOR FRACTURE WITH ROUTINE HEALING Non-Surgical Orthopedic/Musculoskeletal G89.2 OTHER CHRONIC PAIN ESSENTIAL (PRIMARY) HYPERTENSIONR26.2 T DIFFICULTY IN WALKING, NOT ELSEWHERE Z20.828 CONTACT WITH AND (SUSPECTED) EXPOSURE TO OTHER VIRAL COMMUNICABLE DISEASES M62.81 T MUSCLE WEAKNESS (GENERALIZED Z74.1 T NEED FOR ASSISTANCE WITH PERSONAL CARE E78.5 HYPERLIPIDEMIA, UNSPECIFIED H40.9 UNSPECIFIED GLAUCOMA E55.9 VITAMIN D DEFICIENCY, UNSPECIFIED E56.9 VITAMIN DEFICIENCY, UNSPECIFIED E87.6 HYPOKALEMIA D64.9 ANEMIA, UNSPECIFIED",,Pencillin,"['Confusional state', 'General physical health deterioration', 'Pyrexia']",1,PFIZER\BIONTECH,IM 916930,FL,50.0,F,"I did immediately feel some slight dizziness but I also ad worked all night and was exhausted. I was driving home and did become itchy and developed a couple of small hives that quickly went away. The main event that I am reporting is a severe outbreak of eczema. I used to get it on my hands as a child and it was caused by citrus. On the morning of 12/24, I noticed itching and a red rash starting on my right wrist and my left hand. I thought perhaps it was from over washing or not rinsing all of the soap off. The rash became worse and I noticed a small area above my lip on the left side, I then developed a large area on the right side of my lower face. There were also a few spots elsewhere but these were the worst.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/24/2020,3.0,WRK,"metoprolol, Adderall, Xanax, Multivitamin, Singular",Environmental allergies,HTN Allergies Asthma,,PCN Citrus,"['Dizziness', 'Eczema', 'Fatigue', 'Pruritus', 'Rash', 'Rash erythematous', 'Urticaria']",1,PFIZER\BIONTECH,IM 916932,VT,54.0,F,"lightheaded,dizzy, and nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Levothyroxine,atorvastatin",none,"hypothyroidism,hyperlipidemia",,none,"['Dizziness', 'Nausea']",1,MODERNA,IM 916933,CA,33.0,F,Moderna COVID-19 Vaccine EUA. Tingling in the right arm. Also sore ness on the right shoulder. Itchy ness in the throat and miner headaches.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,UNK,Vitamins,,,,,"['Headache', 'Musculoskeletal discomfort', 'Paraesthesia', 'Throat irritation']",1,MODERNA,IM 916934,AZ,28.0,M,Pfizer-BioNTech COVID-19 Vaccine EUA Fatigue 12/29 in the evening Fever 12/29 starting at 11 pm to late morning 12/30 Light nausea 12/29 from 11 pm to 3:00 am Headaches 12/29 through 12/31 Muscle aches 12/29 through 12/31 particularly lower back I rested and drank so much water and the symptoms went away on their own,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,UNK,None,None,None,,None,"['Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 916935,OH,54.0,F,"Headache, fever, chills, nausea, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,methylprednisolone,"Within two weeks of vaccine: General malaise, sore throat, low grade fever of 99, headache",none,,none,"['Chills', 'Dizziness', 'Headache', 'Nausea', 'Pyrexia']",UNK,MODERNA,IM 916936,TX,50.0,F,"At the 10th day redness, swelling, itchy arm at site on injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,OTH,"Ibuprofen, Multivitamins",None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 916937,UT,22.0,F,Large swollen bump at injection site that has grown for 48 hours since injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PUB,,,,,,['Injection site swelling'],UNK,MODERNA,SYR 916938,UT,46.0,M,"Vaccine was not administered Intramuscular by RN administering it. It was administered into the shoulder joint of the left arm. Approximately 6 hours later, severe pain, unable to lift arm and shoulder, tingling in left arm and hands. Progressed to very limited movement of left arm and unrelieved pain. Treatment sought at ER where diagnosis was traumatic hemmorhagic bursitis from vaccine needle.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"Adderall 20mg XR, Adderall 20mg IR, Lisinopril 10mg",None,None,,None,"['Blood chloride normal', 'Blood creatinine normal', 'Blood glucose normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea normal', 'Bursitis', 'C-reactive protein increased', 'Carbon dioxide normal', 'Haematocrit normal', 'Haemoglobin normal', 'Injected limb mobility decreased', 'Osteoarthritis', 'Pain', 'Paraesthesia', 'Platelet count', 'Product administered at inappropriate site', 'Red blood cell sedimentation rate normal', 'Traumatic haemorrhage', 'Ultrasound scan abnormal', 'White blood cell count normal', 'X-ray limb abnormal']",1,MODERNA,IM 916940,MD,37.0,F,"3 months postpartum and breastfeeding, had low grade fever to 99 within hours and fatigue/myalgias. This increased to chills, a temp of 101f (baseline 97.8), and myalgias/fatigue so severe Going to the restroom felt like running a marathon (which I have done). I had to fully lay down and couldn?t carry my 15lb son. I also had marked breast tenderness greater on the side of the injection. My son seemed to have trouble staying latched (?due to tiredness from my direct warmth), and had increased fussiness. I have never had more than a mild local injection reaction w tenderness with any other vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,Prenatal vitamin,Breastfeeding/ 12 weeks post partum,None,,None,"['Breast tenderness', 'Chills', 'Fatigue', 'Feeling abnormal', 'Malaise', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 916941,CA,45.0,F,Numbness of pad of right thumb (vaccine was in left arm) starting 1 he after vaccine and persisting 48 hrs after.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,Levothyroxine 50 mcg daily Lexapro 10 mg daily,None,Hashimotos thyroiditis Anxiety Depression,,NKDA,['Hypoaesthesia'],1,MODERNA,IM 916942,VT,52.0,F,"nausea,woozy, and hot",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,levothyroxine,non e,hypothyroidism,,"erythromicin,lactose","['Dizziness', 'Feeling hot', 'Nausea']",1,MODERNA,IM 916943,MA,35.0,M,"After administration, patient experienced difficulty breathing, headache, anxiety, and elevated blood pressure (160/102 - 180/110 for 30 minutes). Patient was transported to Hospital as precaution.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,,"['Anxiety', 'Blood pressure increased', 'Dyspnoea', 'Headache']",1,PFIZER\BIONTECH,SYR 916944,NJ,47.0,M,"Low grade fever 100.3, tired",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,"cardizem, xarelto",,,,,"['Fatigue', 'Pyrexia']",1,MODERNA,SYR 916945,NJ,27.0,F,Pfizer-BioNTech COVID-19 Vaccine EUA Extremely sore arm Ipsilateral neck stifness/soreness for greater than 72 hours Headache for 72 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,Glucosamine Chondroitin,none,none,,none,"['Headache', 'Musculoskeletal stiffness', 'Neck pain', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 916946,MA,41.0,M,"Patient had a fever (T100), severe body aches, and diarrhea one day post immunization. [note; COVID recovered April 2020]",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,SEN,,,,,,"['Diarrhoea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 916948,TX,64.0,M,Moderna COVID-19 Vaccine EUA Swelling and soreness from the injection site to the elbow.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,"81 MG aspirin, 50+ multiple vitamin, Glucosomin-eCondroitan, Zinc, Vitamin B, Fiber Capsule,",None,None,October 2019 Shingles - Felt poorly for 48 hours,Z-Pack,"['Injection site pain', 'Injection site swelling']",UNK,MODERNA, 916949,CA,43.0,F,COVID Vaccine received on 12/30/2020 at 2:00pm on her left deltoid. On 12/31/2020 she reports severe fatigue8/10) with LUE burning and numbness from injection site to her 4th and 5th digit on her Left hand. She took Tylenol at 0500 am with minimal relief noted. She also reports around 9:00 pm her right eye began to swell and she took 25 mg of Benadryl with some improvement noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,"trajenta, Vitamin C, Atrovastatin, metroprolol, Hyzaar, sambucus",none,,,"Bees, PCN, Pineapple","['Burning sensation', 'Eye swelling', 'Fatigue', 'Hypoaesthesia', 'Injection site hypoaesthesia', 'Injection site pain']",1,MODERNA,IM 916950,MA,62.0,M,"Patient experienced one day post immunization malaise, moderate headache, and chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,SEN,,,,,,"['Chills', 'Headache', 'Malaise']",1,PFIZER\BIONTECH,SYR 916951,MA,33.0,M,"About 24 hours after receiving the vaccine I woke up with a fever, headache, bodyaches and fatigue. Symptoms resolved with Tylenol. The next day symptoms continued along with lymph node pain in the right armpit. All symptoms resolved by day 3 post injection. Also note, I was symptomatic and tested positive in August with all of the previously stated symptoms except for lymph node pain. Symptoms post vaccine were much more mild than the actual infection with covid.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,WRK,"15 mg adderall, men?s multi vitamin",None,None,,None,"['Fatigue', 'Headache', 'Lymph node pain', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 916952,CA,25.0,F,Fainting possibly due to pain Patient given motrin and sleeping at home,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,None,None,None,,Clindamycin,"['Pain', 'Syncope']",1,MODERNA,IM 916953,MD,47.0,F,"Left side area of spleen, splenomagaly to palpation. Dull ache, increased pain on inspiration, sharp pain to palpation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,"Zyrtec, vitamin c, zinc, multivitamin, vitamin D,",Eczema flare,"Eczema,",,None,"['Pain', 'Painful respiration', 'Splenomegaly', 'Tenderness']",1,PFIZER\BIONTECH,IM 916954,WA,45.0,F,"PAIN AT INJECTION SITE, MUSCLE ACHES, FATIGUE, METALLIC TASTE, HEADACHE",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/01/2021,2.0,WRK,,,,,,"['Dysgeusia', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia']",1,MODERNA,IM 916955,NC,45.0,F,"12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 days ago. The site on her left deltoid where she got the shot is warm and read. It also itches. No pain into the rest of left arm. no numbness of tingling at site or distally. no trouble breathing or tingling around mouth/throat. 01/01 - EE notes that her arm was very sore and she had a bad headache. As the days went on, it got redder, hotter, and more swollen. On 12/20, she began to feel bad. On 12/28 while at work, she heard that her supervisor was COVID (+). Throughout the day she felt worse and worse. Was seen at urgent care and COVID was negative. Prescribed Cephalxin and predinose 01/01 -- arm is much better today. Today it is still bruised. She thinks it was bruised previously but that the bruise could not be seen under the redness and swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,,none,none,,augmentin- stomach cramps but no other allergies,"['Feeling abnormal', 'Headache', 'Injection site bruising', 'Injection site erythema', 'Injection site pruritus', 'Injection site warmth', 'Pain in extremity', 'Peripheral swelling', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 916956,NV,80.0,F,"fatigue, headache, muscle pain, joint pain, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,amlodipine; Synthroid; Liothyonine; Lipitor; Prolia,none,mild COPD,,none,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia']",UNK,MODERNA,IM 916957,NM,56.0,F,"upset stomach , diarrhea , muscle pain, soreness & stiffness at site of injection in left arm upset stomach started around 11:00am & went away after having bowel movement, it returned again around 2:00pm & again went away after bowel movement, it returned for a third time around 3:00pm & that is when the diarrhea occurred. That was the last time of any signs or symptoms. I drank 2 cups of ginger tea afterwards which seem to help settle my stomach. The muscle pain, soreness & stiffness in left arm at injection site started at bedtime around 9:00pm on the day of receiving vaccine & still continues today but is improving",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Levothyroxine, gabapentin, valacyclovir, cyclobenzaprine, multivitamin, vitamin D",none,"fibromyalgia, hypothyroidism, herpes II",,Plaquenil,"['Abdominal discomfort', 'Diarrhoea', 'Injection site pain', 'Injection site reaction', 'Musculoskeletal stiffness', 'Myalgia']",1,PFIZER\BIONTECH,IM 916958,WA,49.0,F,"Intermittent fever , sore throat fatigue for over 5 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/26/2020,3.0,PVT,None,None,None,,None,"['Fatigue', 'Oropharyngeal pain', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 916959,MI,29.0,F,Headache 10 mins after shot.... 2 hours after shot arm became swollen and extremely hot... Along with face becoming red and hot... Became super tired and eyes sunken in... Raised temperature... After 5 hours all of the above subsided besides fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,Had to take benedryl and Tylenol to help calm down adverse reaction,None,None,,"Bactrim, Raisins and raspberries","['Body temperature increased', 'Erythema', 'Fatigue', 'Feeling hot', 'Headache', 'Lid sulcus deepened', 'Peripheral swelling', 'Skin warm']",1,MODERNA,SYR 916960,TX,40.0,F,"Dizziness, nausea, vomiting, HA, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Spirolactone 100mg daily,none,none,,NKDA,"['Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 916961,MA,34.0,F,"Patient reported one day post immunization moderate body aches, headache, severe throbbing injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,SEN,,,,,,"['Headache', 'Injection site pain', 'Pain']",1,PFIZER\BIONTECH,SYR 916962,CA,60.0,M,"Sore arm, fatigue,chills ,nauseousness ,vomiting on 12/292020 . Chills ,nausea, vomiting started around 6 pm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/29/2020,,WRK,"Metformin, flecanide, pradaxa,atorvastatin,lisinopril,claritin,famotadine, multi vits",,"Disbetes, afib",,"Penicillins, ciprofloxacin, sulfas","['Chills', 'Fatigue', 'Nausea', 'Pain in extremity', 'Vomiting']",1,MODERNA,IM 916963,NJ,38.0,F,"Injection site had developed redness, elevation and warm to touch 8 days after vaccination was given. Topical benadryl applied to site to lessen redness..",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/30/2020,8.0,PVT,fexofenadine 180mg by mouth daily,none,none,,hydromorphone,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 916964,FL,36.0,M,"Pain at injection site, nausea, tired, headache, muscle pain, joint pain, and cough.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Anti-histamine.,Nothing special.,Nothing special.,,"Hay fever, mouse allergy.","['Arthralgia', 'Cough', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea']",1,MODERNA,IM 916965,MA,88.0,F,Patient reported one day post immunization to be experiencing extreme fatigue- unable to get out of bed for usual daily routine,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,SEN,,,,,,"['Fatigue', 'Loss of personal independence in daily activities']",UNK,PFIZER\BIONTECH, 916966,TX,51.0,F,"*12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, with pain, on Right side of body with increased sensitivity at Left Axillary/side of breast area. Onset on 12/30 Fever, Severe Body aches/joint pain, dry cough, chest pain with min SOB, Headache. *Exposure to 4 people on Sat 12/26 who have tested positive for Covid on 1/1/20 but their symptoms began 12/28 through 01/30.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/28/2020,7.0,OTH,"Vitamin D3, Zinc, B-Complex,Multivitamin",None,High Cholesterol,,Adverse reaction to prednisone and hydrocortisone,"['Arthralgia', 'Breast tenderness', 'Chest pain', 'Cough', 'Dyspnoea', 'Exposure to SARS-CoV-2', 'Headache', 'Influenza virus test negative', 'Injection site pain', 'Lymph node pain', 'Lymphadenopathy', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Streptococcus test negative', 'Tenderness']",1,PFIZER\BIONTECH,IM 916967,MI,38.0,F,"Chills, started 8:30 ish in the morning after I woke up today and lasted for half an hour. Second time I had severe chills around 1:45 pm in the afternoon. And My right arm has soreness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,WRK,No,No,No,,Mushroom,"['Chills', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 916969,CO,88.0,F,"Anaphylactic like reaction started with dizziness sweating increased heart rate wheezing in and out of consciousness. administered 0.3 of epinephrine, O2 via NC at 3L. called EMS. EMS arrived with in 10 minutes and administered additional 0.5 of Epinephrine and transported patient to the ER",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,PUB,UK,UK,UK,,PNC Sulfa,"['Anaphylactoid reaction', 'Consciousness fluctuating', 'Dizziness', 'Heart rate increased', 'Hyperhidrosis', 'Wheezing']",1,MODERNA,IM 916970,CA,41.0,F,"Migraine x 4 days, nausea off and on x 3 days, itching arms and stomach x 2 hours, fatigue x 2days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"Atenolol, Botox, excedrin",None,"HTN, migraines",,None,"['Fatigue', 'Migraine', 'Nausea', 'Pruritus']",1,PFIZER\BIONTECH,SYR 916971,MO,26.0,F,"Pt states got Covid vaccine today ay 730am, shortly after started feeling dizzy and scratchy throat. She was sent to the ED. ED treated as follows: Solu-Medrol, Benadryl and Pepcid given intravenously. Patient was monitored in the emergency department for improvement of symptoms. Her throat fullness and pruritus resolved. She feels well and wishes to be discharged home. Pepcid, Benadryl and prednisone prescribed for treatment of any recurrence of allergic reaction symptoms that might occur when she is discharged. She will return to the hospital should symptoms worsen. She returned to the ED the next day and these are notes from that visit: 26-year-old female, past medical history significant for asthma and irritable bowel syndrome presents to the emergency department with complaint of allergic reaction. Patient states she took the Covid vaccine yesterday and with 8 minutes developed tightening in her throat and rash. She presented to the emergency department yesterday and was treated with Solumedrol, Pepcid and Benadryl which relieved her symptoms. She was discharged home with Pepcid Benadryl and prednisone however she has not taken the prednisone because she does not like how it makes her feel. She states this morning she developed tightness in her throat, nausea and felt as if she were going to pass out. She states when her symptoms began she took Pepcid and Benadryl but did not take any prednisone. Upon arrival she is very anxious, talking in complete sentences, no drooling noted 1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes. Initial read by Dr. at 1243 � 1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms. Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety. I have encouraged her to take the prescriptions as directed at her ER visit yesterday. Procedures � MDM � Return the emergency department new symptoms or concerns worsening of current condition.1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes. Initial read by Dr. at 1243 � 1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms. Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety. I have encouraged her to take the prescriptions as directed at her ER visit yesterday. �",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Albuterol Inhaler (Proair) one puff every 6 hours as needed for bronchospasm Guaifenesin (Mucinex) 600mg 1 tab every 12 hours as needed for congestion,no acute illness,asthma,,azithromycin,"['Altered state of consciousness', 'Anxiety', 'Dizziness', 'Electrocardiogram abnormal', 'Hypersensitivity', 'Nausea', 'Rash', 'Sinus tachycardia', 'Throat irritation', 'Throat tightness']",1,PFIZER\BIONTECH,IM 916972,TN,29.0,F,Tachycardia starting an hour after injection and lasting 2 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,,['Tachycardia'],1,MODERNA,IM 916973,NJ,62.0,F,"At 2 am started with chills, headache, aches and pains. Progressed to 100 temp and severe headache, chills and aches. Spent 2 days in bed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,Valsartan/hctz.,None,Hypertension,I had a rash many years ago from hepatitis vaccine when it had thimerisol in it,Thimerisol,"['Body temperature increased', 'Chills', 'Headache', 'Pain']",1,MODERNA,IM 916974,CA,60.0,F,"101 fever, severe chills, nausea and vomiting, splitting headache and feeling of all nerve endings being inflamed. Hands initially purple than swollen. Severely ill for about 16 hours but took another 24 for full recovery.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,Dulera Inderal Protonix,None,Asthma,Shingrix 9/20,Shellfish and milk,"['Chills', 'Feeling abnormal', 'Headache', 'Malaise', 'Nausea', 'Peripheral swelling', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 916975,MI,28.0,F,Vomited suddenly without knowledge of being nauseous; only happened once but nausea remained after. After about an hour and a half muscle aches and headache kicked in.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,OTH,Cymbalta Metformin Vancomyacin Keflex Prenatal vitamin Progesterone,None,Fibromyalgia Asthma Pcos,,Amoxicillin,"['Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 916976,WA,42.0,F,Redness about 2 inches around with swelling and pain started about 24 hours after vaccine. Pain resolved by 3 days after vaccine and swelling decreased a lot. I Continue to have redness with mild swelling about 2 inches around injection site now with mild itching at 9 days after the shot.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,WRK,None,None,None,,"Delayed type hypersensitivity to latex, mango, and poison oak.","['Erythema', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Pain', 'Swelling']",1,MODERNA,SYR 916977,TX,39.0,F,"1255: Informed patient was experiencing nausea, no other symptoms to report; BP: 150/98; HR:100;RR:24; no LOC, not diaphoretic, having no other symptoms other than nausea. This nursed placed cool towels to patient's anterior and posterior neck - per patient, ""it felt good."" Patient transferred to a cot from her chair and placed in a supine position. 1300: BP:138/78; HR:80; RR:20; O2 sat:99%; patient stated nausea feeling was fading 1305: BP:132/76; HR:82; RR:16; O2 sat:97%; patient stated she was barely feeling any nausea 1310:BP:132/72; HR:76;RR:16; O2 sat 99%; patient sat up slowly and denied c/o dizziness; still with minimal nausea. Had three small sips of cool water and tolerated w/o emesis. 1330:Patient cleared by this nurse and patient was escorted out by her co-worker. Nausea had resolved. 01/01/20201: This nurse contacted patient @ 1634 and asked patient to return call.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,Allegra - PRN,None,None,,Seasonal allergies,['Nausea'],1,MODERNA,IM 916978,TX,66.0,M,"Patient reports ""disorientation"". He states that ""it might not be the vaccine though because my doctor is adjusting my Levothyroxine dosage right now"". It lasted a couple of days. Symptoms improved at the time of the completion of this report.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PHM,Cyclobenzaprine; Duloxetine; Atorvastatin; Levothyroxine (dosage recently adjusted up to 200mcg); Lisinopril; Tramadol; Zinc Sulfate; Vitamin C; and Vitamin D,None,Diagnosed with severe case of COVID (in June 2020?); HTN; High Cholesterol; Thyroid insufficiency; Pain,,Sulfasalazine,['Disorientation'],1,MODERNA,IM 916979,FL,37.0,F,"Exactly one week post vaccination, woke up to peri injection site erythema, slightly raised with irregular border. Site measured 4cm x 12 cm x 2mm. This was accompanied by a strong metallic taste in mouth that was similar to experience at time of original injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/30/2020,8.0,PVT,none,none,none,,"NKDA, no known food allergies","['Dysgeusia', 'Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 916980,,55.0,F,"Patient was given 0.5mL of the Moderna vaccine at 1503. She states that immediately after receiving the vaccine she started having tingling in her throat. She thought it was anxiety, so she waited awhile. She states it started getting worse and she notified the RN. Patient stated that in the past she has experienced a tingling sensation in her throat, but it went away. Patient denied shortness of breath or rash. BP 120/78, oxygen 97, pulse 46, respirations 20. �RN gave 50mg IM of Benadryl at 1530 per protocol. Patient stated after 5 minutes that her throat felt tight. Patient was taken over to convenient care to be evaluated.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,PVT,,,,,,"['Immediate post-injection reaction', 'Pharyngeal paraesthesia', 'Throat tightness']",1,MODERNA,IM 916981,,37.0,F,"A rash developed near site of injection a week after getting first dose of moderna covid 19 vaccine. It?s itchy, red, hot to touch, and raised. Size is about 2 inches wide and not uniformed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,UNK,Glycopyrrolate 1mg daily,,,,Sulfa,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,MODERNA,IM 916982,WA,40.0,F,"Sore arm at the site x 3 days. that evening fatigue, myalgias. at 4 am the next morning awoke with abdominal pain, nausea, then an episode of liquid stool. These continued throughout the next day until the evening of day 2. By morning of day 3 they were gone",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,buproprion XL 150 mg,none,none,,bee venom,"['Abdominal pain', 'Diarrhoea', 'Fatigue', 'Injection site pain', 'Myalgia', 'Nausea', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH,IM 916983,AZ,49.0,F,"Headache, diarrhea, and body aches, patient given Tylenol in ED with improvement and discharged home",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PVT,None,None,Obesity,,Nitrofurantoin,"['Diarrhoea', 'Headache', 'Pain']",UNK,MODERNA,IM 916985,DC,27.0,F,"I woke up with significant right-sided facial and eye swelling currently still present although improved in severity. Other symptoms included pain/heat at injection site, myalgias, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/01/2021,1.0,UNK,"Junel, Omeprazole",none,"GERD, asthma",,none,"['Eye swelling', 'Fatigue', 'Injection site pain', 'Injection site warmth', 'Myalgia', 'Swelling face']",1,PFIZER\BIONTECH,IM 916986,GA,66.0,F,Fatigue Headache Joint Pain Fever Chills Muscle Pain Injection site swelling Diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,Symbicort Meloxicam Chlorthalidone Pravastatin Losartin Norvasc Daily Vitamin Tumeric cercumen Calcium with Vitamin D,None,Osteoarthritis,,Scallops Erythromycin Morphine,"['Arthralgia', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Injection site swelling', 'Myalgia', 'Pyrexia']",1,MODERNA,SYR 916987,PA,59.0,M,"Arm pain at site, Tenderness, Headache, Fever over 101.8, Muscle pain, Joint pain, Nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,"Metformin, Pantoprazole, Nifedipine, Metoprolol, Escitalopram, Atorvastatin, Lisinopril, 81 mg aspirin, Humalog insulin, Toujeo Insulin",None,"Diabetic, Heart Disease, High Blood Pressure",,None,"['Arthralgia', 'Headache', 'Myalgia', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Tenderness']",1,MODERNA,SYR 916988,,36.0,F,Severe soreness. Difficult to raise arm above head because it feels ?tight?.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,SCH,Ibuprofen PM the night before,None,None,,Penicillin,"['Mobility decreased', 'Pain']",1,MODERNA,SYR 916989,AZ,29.0,F,Tuesday: headache and sore arm came around evening time then at night a fever of 102 kicked in. Wednesday: 102-101 fever took only ibuprofen Thursday: called doctor fever 99-101. Tyenelol and antibiotics and immune boosters Friday: doctor oncall told me to continue meds and she will call me back on Saturday. Fever still 99-101 range.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,SCH,Ibuprofen 800mg Probiotic Iron 325 mg Levothyroxine 25mg,None,Splenectomy,,None,"['Headache', 'Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 916990,MA,29.0,F,"Red, well circumscribed, slightly raised, lesion at site of injection. Approx 2 inches in diameter. Not itchy or painful. The lesion appeared this morning at 9am and is still present 8 hours later.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,01/01/2021,8.0,PUB,None,None,None,,None,"['Injection site erythema', 'Injection site reaction', 'Injection site swelling', 'Skin lesion']",UNK,MODERNA,SYR 916991,AZ,39.0,F,Woke up at 8am with soreness at the injection site. Started feeling feverish at 3pm.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,PVT,None,None,None,,"Penicillin, rocephine and crustaceans","['Injection site pain', 'Pyrexia']",1,MODERNA,SYR 916992,VA,45.0,M,"I woke up at 2am in morning after vaccination on prior day with extreme cold chills. After 2 hrs. of stacking blankets on me and putting a heating bad, my chills finally minimized. During this time, I also became nauseated and puked several times. after these events, I had a severe headache for most of the following day and a very sore arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PUB,,,,,,"['Chills', 'Feeling cold', 'Headache', 'Limb discomfort']",UNK,MODERNA,SYR 916993,CA,48.0,F,"Pt felt dizzy and nauseous after vaccine administration. When she tried to get up, she experienced syncope for about one minute. We administered Epi-pen and pt regain consciousness. Asked facility and patient if 911 call was needed, but patient refused. We monitored her blood pressure for over 1 hours and she stabilized at her baseline. We released her to go home and she will continue to monitor other potential adverse reactions.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,SEN,,,Multiple Sclerosis,,None,"['Dizziness', 'Loss of consciousness', 'Nausea', 'Syncope']",1,PFIZER\BIONTECH,IM 916994,,30.0,M,"Redness, soreness, swelling, and warmth at and around injection site. Onset of symptoms was within the first 24 hours. Area affected increased in size (approximate diameter of 3-4 inches) up to48 hours following vaccination. It is currently 72 hours following vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,UNK,,,,,Sulfa antibiotics,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 916995,WI,60.0,F,"I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Lightheaded , some dizziness that night. Forced the water intake. 12-30-2020, went to work, as the day went on the rash on my face and neck into upper chest increased and Hypertension. I went to the ER Dept at Hospital. IV Fluids and IV Benadryl and oral Prednisone and Prednisone to be taken at home. Face and neck rash goes away and comes back as of Jan 1 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Meloxicam 15 mg with breakfast, Vitamin D",NO,Osteoarthritis,,,"['Dizziness', 'Flushing', 'Full blood count', 'Hypertension', 'Laboratory test', 'Rash']",5,PFIZER\BIONTECH,IM 916996,IA,37.0,F,"Fevers developed 10 hours after injection. Fever of 102 lasted for more than 24 hours. Fevers treated with Tylenol. On day two after injection, I developed a rash and hives all over, also shortness of breath. Have taken 50 mg of Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,"Clobetasol, Benadryl","Covid positive on Dec 10th,",Psoriasis,,None,"['Dyspnoea', 'Pyrexia', 'Rash', 'Urticaria']",1,MODERNA,SYR 916997,IA,44.0,M,"Fever, up to 100.9F, injection site pain, headache, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,"Vyvance, adderall, artovostatin, cetirizine, omeprazole",None,"Hyperlipidemia, seasonal allergies, GERD",,None,"['Headache', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 916998,IL,36.0,F,"Skin rash and hyper-pigmentation in the area of the band-aide. Basically a band-aid imprinted rash that burns, very dry. The imprint has not resolved, only increased hyper-pigmentation and raised skin rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,WRK,None,COVID-19 prior to the vaccination,None,,None,"['Injection site dryness', 'Injection site pain', 'Injection site reaction', 'Rash', 'Rash papular', 'Skin hyperpigmentation']",1,PFIZER\BIONTECH,IM 916999,OK,47.0,F,Injection site very sore Nausea Fatigue Chills Body aches Back pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Lorsartan Aspirin Metaprolo Synthroid Atorvastatin,None,High blood pressure Previous thyroid cancer High cholesterol,,Pecans Darvocet Flagyl,"['Back pain', 'Chills', 'Fatigue', 'Injection site pain', 'Nausea', 'Pain']",1,MODERNA,SYR 917000,NC,61.0,U,"Fevers, chills, malaise everyday at 2:00pm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,09/13/1959,12/27/2020,22386.0,PUB,Piper Cillian for MRSA,MRS/A right knee,high BP Diabetes,,,"['Chills', 'Malaise', 'Pyrexia']",2,MODERNA,IM 917001,ID,48.0,F,Very sore injection site muscle. Hurt to lay on it.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,,None,Reactive hypoglycemia Osteoarthritis Fibromyalgia,,Gluten Dairy,"['Injection site pain', 'Myalgia']",1,PFIZER\BIONTECH,IM 917002,MD,40.0,M,fever of 100.4 started around 02:30PM until 06:00PM on 1/1/20. Chills and headache.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/01/2021,3.0,MIL,"Lisinipril/HCZT, Effexor, Pantroprazol, B vitamin supplement",none,arthritis,,no known,"['Chills', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917003,WI,48.0,F,"On 1/1/2021, in the early morning, I started having severe shoulder pain in my right shoulder (the arm opposite of the injection site arm). By the afternoon the pain was so bad that I was unable to lift my arm all the way. I sent a message to my PCP but have not heard back yet, probably because it is a holiday. I have been applying ice and heat to the area with little relief.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,WRK,Metformin ER Ozempic Glimepiride Celebrex Aspirin Estradiol Clobetasol Cream,none,Diabetes Osteoarthritis Dyshidrosis,,morphine,"['Arthralgia', 'Mobility decreased']",1,PFIZER\BIONTECH,IM 917004,AZ,23.0,F,"Approximately 9 hours after vaccination, began to have severe pain at injection site, fever of 101.9F, chills, sweats, abdominal pain, and vomiting. This lasted through the night but alleviated the following day. 2 days after vaccination, all symptoms were gone",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,UNK,Rifampin,Covid-19 diagnosis 11 days prior to vaccination,Mild asthma,,None,"['Abdominal pain', 'Chills', 'Hyperhidrosis', 'Injection site pain', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,SYR 917005,MI,25.0,M,"Patient, ""Starting just hours after the vaccine I felt exhausted. I slept for a long time and woke up the following day with the standard arm pain but I also had extreme fatigue and a headache as well as a productive cough. That lasted for over 48 hours. On the third day I had fatigue, cough, body aches and a headache. I received a rapid covid test on the 31st that was negative and the nurse practitioner said that she believed that I was either having a bad reaction to the vaccine or bronchitis or pneumonia. Last night I had all of the same symptoms as days prior as well as tightness in my chest and a obvious upper respiratory infection.""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,None known,None reported,None known,,Known known,"['Bronchitis', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Pneumonia', 'Productive cough', 'SARS-CoV-2 test negative', 'Upper respiratory tract infection', 'Vaccination complication']",1,PFIZER\BIONTECH,IM 917006,MA,35.0,M,"Slight numbness on the left side of my face, starting somewhere around a half an hour to an hour after injection. It is now 28 hours after receiving the vaccine and the numbness is still present but milder than this time yesterday. Additionally, there was a very slight sensation of tightness in my throat that has almost completely subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Bupropion XL 300mg 1/day, dextroamphetamine 10mg/twice/day",None,None,,Celiac disease (gluten),"['Hypoaesthesia', 'Throat tightness']",1,MODERNA,IM 917007,NY,38.0,F,Significant increase in pain and tenderness of right arm where I had fallen/broken my radial head at the olecranon. Also worsening of hip pain on the right where i have chronic hip pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,"Finacea topical, clindamycin topical",Broken radial head after fall (olecranon),Acne SVT,,None,"['Arthralgia', 'Fall', 'Fracture', 'Injection site pain']",UNK,PFIZER\BIONTECH,SYR 917008,MA,54.0,F,"Joint pain in left arm 1 hour after injection. Became slightly light headed. Ate and had large coffee and it resolved. After almost a day, a 2 inch circle around injection site became painful, red, swollen/hard & very warm. Took 400 mg Motrin every 6 hrs & 25 mg Benadryl every 12 hrs. Sx lasted 48 hours before improving slowly. After 4 days, lump & redness is mostly resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/29/2020,1.0,PVT,Fexofenadine,,Sinus allergies/congestion,,Seasonal allergies,"['Arthralgia', 'Dizziness', 'Injection site erythema', 'Injection site induration', 'Injection site mass', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 917009,OH,57.0,F,"Moderna COVID-19 Vaccine Day #7: Developed chills and fever (~100-101) in the evening at around 6.30 pm with night sweats. Fever subsided in the early morning hours (around 4 AM). Day #8: Similar to day #7. Day#9: Some redness at the site of injection in the morning, with developing large wheal in the arm with some itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/30/2020,6.0,PVT,"Zetia, Irbesartan, hydrochlorothiazide, Multivitamins, Magnesium",,,Arm swelling following DT vaccine 13 years ago (2007-2008),"Topical Iodine, ACE inhibitors","['Chills', 'Injection site erythema', 'Injection site pruritus', 'Injection site urticaria', 'Night sweats', 'Pyrexia']",1,MODERNA,IM 917010,VA,51.0,F,"on 12/25 all lymph nodes on the same side as the shot injection swollen, Joint Pain, not w=feeling weel. on 12/31 reported that the lymph nodes near clavicle have now swelled. The other lymph nodes have not ceased being swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/25/2020,3.0,WRK,,,,,,"['Arthralgia', 'Lymphadenopathy', 'Malaise']",1,PFIZER\BIONTECH,IM 917011,AZ,56.0,F,"Heart racing few mins after shot lasted 10 mins then nausea, dizziness continues for 45 mins. Then mild headache for 24 hrs. No symptoms after 24 hrs except sore arm for 2 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,UNK,None,None,Hypothyroidism and Fibromyalgia,,Oxycodone,"['Dizziness', 'Headache', 'Nausea', 'Pain in extremity', 'Palpitations']",UNK,PFIZER\BIONTECH,IM 917012,VA,39.0,F,"Severe Headache for 3 days, chills weakness and fevrerish",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/27/2020,1.0,WRK,,,,,,"['Asthenia', 'Chills', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917013,UT,34.0,F,"patient developed lymphadenopathy 6 days after moderna vaccine ,redness and great amount of swelling at injection site 7 days after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/30/2020,6.0,PVT,none,none,GERD Anemia,,none,"['Injection site erythema', 'Injection site swelling', 'Lymphadenopathy', 'Ultrasound scan abnormal']",UNK,MODERNA, 917014,FL,49.0,F,"Moderna COVID-19 Vaccine EUA Pain, swelling, redness at the injection site started anew 7 days after the vaccine was received. The area was indurated. Also low grade fever. Diagnosed as cellulitis, being treated with oral course of Doxycycline.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,PVT,None,None,None,,None,"['Cellulitis', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Pyrexia']",1,MODERNA,IM 917015,OH,43.0,F,"It has been eight days since the vaccination and noticed I was itchy at the spot, red, swollen? Several hives present.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/01/2021,1.0,UNK,"Remicade, Vitamin D, Zoloft 100 mg",None,Crohns Disease,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Urticaria']",1,MODERNA,IM 917016,TX,64.0,F,"Redness, swelling, hot and discomfort at the injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,OTH,calcium with Vitamin D3,none,none,,none,"['Injection site discomfort', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA,IM 917017,KY,58.0,M,"Tested positive Covid-19 infection, Cough, bronchospasm, weakness, muscle pain, chest congestion, nasal congestion, Loss of appetite since vaccine given,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/28/2020,6.0,PVT,Lisinopril,None,Hypertension,,Latex,"['Asthenia', 'Bronchospasm', 'COVID-19', 'Cough', 'Decreased appetite', 'Myalgia', 'Nasal congestion', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 917018,SD,65.0,F,Some diarrhea and abd pain-almost to nausea stage but have taken some Zofan,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,UNK,"Omeprazole, norvasc, zinc, vit d","Receiving radiation on my arm, close exposure to Covid",HTN,,"Sulfa, lisinopril","['Abdominal pain', 'Diarrhoea', 'Nausea']",1,MODERNA,IM 917019,TX,54.0,F,"itching and redness on arm 8x4 cm, axillary discomfort",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/31/2020,7.0,PVT,"lexapro, claritin, sudafed",none,none,,"pcn, cephalosporins, sulfa","['Discomfort', 'Erythema', 'Pruritus']",1,MODERNA,IM 917020,CO,26.0,F,"Nausea, vomiting, migraine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/31/2020,30.0,PVT,Kyleena IUD,,Mirgraines,,"Hydrocodone, cashews, peanuts","['Migraine', 'Nausea', 'Vomiting']",1,MODERNA,SYR 917021,IN,32.0,F,"Hives around neck, face (cheeks, and around eyes) about 2 hours after vaccine was administered. Reduced appearance of hives after 12 hrs. Cortisone (topical ointment) applied and hives seemed to subside.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,IUD Mirena,None,None,,Shellfish sensitivity,['Urticaria'],1,MODERNA,IM 917022,MO,52.0,F,"Tinnitus, worse in left ear. Heavy feeling all over. Headache, Tylenol 500mg q6h.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,"Lyrica, Tramadol ER, Topiramate, Levothyroxine, Famotidine, Klonopin, Tramadol HCL, Flexeril, Amitriptyline, Iron, Vitamin D3, Quercetin, Zinc, Super Vitamin B-Complex, Rexulti",None,"Fibromyalgia, Anxiety, Depression, Osteoarthritis, Sleep Disorder/Apnea, Hypothyroidism",,Kenalog,"['Discomfort', 'Headache', 'Tinnitus']",1,PFIZER\BIONTECH,IM 917023,NJ,58.0,M,Swollen lips with itchiness and tingling sensation,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,Candesartan Tabs 32mg Rosuvastatin Tabs 5mg,,,,I have had two allergic reactions to shrimp over the years and no longer will eat shrimp I also had an allergic reaction to penicillin based prescription drug years ago,"['Lip swelling', 'Paraesthesia', 'Pruritus']",1,MODERNA,IM 917024,PA,35.0,F,No immediate events. But about 24 hours after vaccination I felt extreme tiredness and some chills which I read is normal but I noticed tingling in my legs. And a cold sensation. No weakness and it resolved in about an hour. Then today 1/1/2021 numbness and tingling/pins and needles in my feet and legs . It lasted a few hours and mostly resolved. I was not sure if there was a possibility of guillian barre occurring post this .,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PVT,Synthroid and birth control pill,None,"Hashimoto?s thyroiditis , celiac disease",,Sulfa . Also celiac disease no cannot eat gluten,"['Chills', 'Fatigue', 'Feeling cold', 'Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 917025,MI,51.0,F,"Severe arm pain, loss of use, swelling, pain score 7-9 on the 0-10 pain scale. Loss of sleep for two nights d/t pain. Pain on day three scores 4-7. Can use arm, but very limited ROM.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,Glucosamine Multivitamin with iron Loratadine Biotin,,,,,"['Insomnia', 'Joint range of motion decreased', 'Pain in extremity']",1,MODERNA,IM 917026,LA,82.0,M,"12/28/2020, Pharmacy staff administered Moderna COVID Vaccine. 12/29/2020, he had not eaten breakfast or lunch but did consume fluids and take his medications. BP =150/70, Temp. = 101.6, Pulse= 102, Respirations= 18 and Oxygen saturation= 97%. Tylenol 650 mg given. It was difficult for him to swallow. Also had no use of right upper extremity and unable to move lower extremity, mouth was drooping and was drooling. Physician in attendance and ordered to send to ER. 1/1/2021, received information from nurse at hospital that patient received a Peg Tube this afternoon and Clinical indication of a stroke.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/28/2020,12/29/2020,1.0,SEN,,,,,Codeine Peanuts,"['Cerebrovascular accident', 'Drooling', 'Dysphagia', 'Facial paralysis', 'Gastrostomy', 'Mobility decreased', 'Musculoskeletal disorder']",1,MODERNA,IM 917027,AR,43.0,F,Erythema/induration at injection site - still monitoring at day 4 post vaccine but continues to grow larger,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,SEN,Levothyroxine,No,Hypothyroidism,"DTaP, cellulitis, 2013, 35",Sulfa Flouroquinolones Pertussis,"['Injection site erythema', 'Injection site induration']",1,MODERNA,IM 917028,NY,63.0,F,"Approximately 18 minutes after vaccine was administered I felt dizzy, lightheaded, heart racing, flushed, tongue felt thick. Blood pressure immediately elevated along with heart rate. I was taken to the emergency room. They performed a EKG and gave me IV decadron and Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Calcium 1,500 mg, 7,000 daily vitd, 50,000 iu monthly vitd,",None,None,,"Cefxil, augmentin , elidel cream","['Blood pressure increased', 'Blood test', 'Dizziness', 'Electrocardiogram', 'Flushing', 'Heart rate increased', 'Palpitations', 'Tongue discomfort']",1,MODERNA,SYR 917029,CA,51.0,F,"About 40 minutes after receiving the vaccine, on the drive home, my face started getting numb and feeling tingling and maybe swollen, also, all of my regular pains in my body, ie. various mouth pains and said pains, certain things that act up in my body, were intensified and more bothersome, and I had a headache that wouldn't go away. I felt ""off"" that night and the next day. Probably like I was mildly sick and fatigued with body feeling sore all over and headachey. About 36 hours after getting the initial dose, I was feeling regular again.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,Adderall,,asthma,,"Codeine, Thimerisol, sulfates, preservatives","['Condition aggravated', 'Fatigue', 'Feeling abnormal', 'Headache', 'Hypoaesthesia', 'Malaise', 'Pain', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 917030,IA,40.0,F,"6 hours after vaccine developed fatigue and mild soreness. Over night had severe muscle and joint pain. The next day muscle/joint pain continued with headache, fatigue, fever, chills, and my urine turned dark brown. The next day fever went away and all symptoms improved except the urine continued to be brown. The following day I was seen at the ER and was diagnosed with hematuria of unknown cause. I have to have a CT scan on Monday to evaluate further.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,Levothyroxine,COVID 19,hypothyroidism,,Bactrim - hives,"['Arthralgia', 'Blood creatine phosphokinase', 'Chills', 'Chromaturia', 'Fatigue', 'Haematuria', 'Headache', 'Myalgia', 'Pain', 'Pyrexia', 'Renal function test', 'Urine analysis']",1,MODERNA,IM 917031,NC,61.0,F,"Lethargic, Diaphoresis, general unwell feeling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,SEN,,,"CHRONIC RESPIRATORY FAILURE, UNSPECIFIED WHETHER WITH HYPOXIA OR HYPERCAPNIa",,"Aspirin, Chlorpromazine, Lithium, Sulfamethoxazole, Sulfamethoxazole/Trimethoprim, Penicillins, Antihistamines","['Hyperhidrosis', 'Lethargy', 'Malaise']",1,PFIZER\BIONTECH,IM 917032,NC,43.0,M,"Itching, swelling and elevated temperature at the injection site 7 days after the injection. Benedryll improved symptoms (50mg for two days) 9 days after injection most of the swelling is gone and itching is diminished.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/22/2020,0.0,PUB,Ostiobiflex and vitamin D3,None,None,,Dermabond (liquid stitches) and severe local reaction to bees,"['Injection site swelling', 'Injection site warmth', 'Pruritus']",UNK,MODERNA, 917033,KS,,F,Loss of fine motor control (typing is difficult) loss of balance leading to falling.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,WRK,,,,,,"['Balance disorder', 'Fall', 'Fine motor skill dysfunction']",1,MODERNA,IM 917034,MA,34.0,F,"Painful lymphadenopathy (cervical, supraclavicular), unilateral on same side of injection. Began on Day 5-6",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,01/01/2021,6.0,UNK,,,,,,['Lymphadenopathy'],1,MODERNA,IM 917035,GA,38.0,M,"Moderate vaccine site pain (~9 hrs after vaccine) + moderate/severe fatigue (started ~12 hrs after vaccine administered) + severe chills, low-grade fevers, moderate muscle aches, severe bone aches, moderate joint aches, and mild headaches (started ~18-24 hrs after vaccine administered). Ibuprofen (Motrin) 400 mg total and Acetaminophen 500 mg decreased/improved symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,None,None,High Blood Pressure,,None,"['Arthralgia', 'Bone pain', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia', 'Vaccination site pain']",1,MODERNA,IM 917036,CA,60.0,F,Right chest wall pain and shortness of breath,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2019,12/28/2020,371.0,UNK,Levothyroxine,None,Hypothyroidism,"Nausea, vomiting, Flu vaccine, age 40, 2019, unknown brand, no reactions to flu vaccines since then. That was my first flu va",None,"['Chest X-ray', 'Dyspnoea', 'Fibrin D dimer', 'Full blood count', 'International normalised ratio', 'Metabolic function test', 'Musculoskeletal chest pain', 'Prothrombin time', 'SARS-CoV-2 test', 'Troponin']",1,MODERNA,IM 917037,MN,42.0,F,"Dizziness, nausea, diaphoresis, syncope/fall. Totally blacked out and fell. Helped back to bed, covered in sweat. No fever. Layed in bed until next morning around 10am, still dizzy and nauseated.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,"Lamictal, gabapentin, cymbalta, prilosec, metoprolol, birth control, claritin",None,"Depression, anxiety, hypertension, acid reflux",,Neosporin,"['Dizziness', 'Fall', 'Hyperhidrosis', 'Loss of consciousness', 'Nausea', 'Syncope']",1,PFIZER\BIONTECH,IM 917039,AZ,34.0,F,"It was almost the end of my 15 minutes when my limbs became tingly and that feeling made its way towards my torso. I started to feel flush and my heart rate rapidly increased. I felt it was nothing so i tried to calm myself and watch my heart rate on my watch and it continued to increase. It started at 100 and within a minute was at 130. I finally honked my horn for assistance and my symptoms continued. I became very faint and nauseous and felt as though i was going to throw up. open my door and took my mask off to help with getting air and it didn't do much to help. I felt very light headed and uncomfortably closet o passing out than i ever have. This lasted for a good 10 minutes until it slowly passed. Faint, nauseous, hot and rapid heart rate of 130 were my main symptoms and were very uncomfortable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PUB,"Fluoxetine 20mg NuvaRing Qudexy 50mg Naratriptan/Zolmatriptan/Ubrelvy (as Needed) Pre-Natal Vitamins Vitamin C, C complex, & D",None,None,,Percocet,"['Dizziness', 'Feeling hot', 'Flushing', 'Heart rate increased', 'Nausea', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 917040,OK,19.0,F,Arm hurt badly about 10 hours after shot. Felt super weak and tired too the whole day and the next day. A rash started on my neck and traveled down to my collar bone area by day 4,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"Yasmine birth control, tretinoin",None,None,,None,"['Asthenia', 'Fatigue', 'Pain in extremity', 'Rash']",1,MODERNA,UN 917041,FL,68.0,F,Rash on inner thighs and inner arms (still there on 1/1/21,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,"Levothyroxin, Provastatin, Telmisartan",None,Asthma induced my cigar/cigarette smoke and fragrances HBP high cholesterol,,"hycodone, Lipitor, erythromycin, etodolac, baclofen",['Rash'],1,MODERNA,SYR 917042,MI,43.0,M,"I received the vaccine at 6:30pm on 12/27. I worked atb7pm and took lunch at 2:00am. After lunch, I immediately felt sick to my stomache and threw up. I went home after my shift and went to bed. After 5 hours, I woke up and went to the couch to lay down while kids watched TV. Next, I woke to several people in my house. I had a seizure and my son had called 911. I was taken to emergency department. I was admitted and stayed 2 nights in the hospital.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,12/27/2020,12/28/2020,1.0,PVT,None,None,None,,None,"['Computerised tomogram', 'Electrocardiogram', 'Electroencephalogram', 'Loss of consciousness', 'Magnetic resonance imaging', 'Nausea', 'SARS-CoV-2 test negative', 'Seizure', 'Vomiting']",1,MODERNA,IM 917043,HI,58.0,F,"Hands turned red with slight swelling. Face and chest with red blotches. Nausea and pounding heart rate. This is the same symptoms I experience if I drink alcohol. I drank water and it got better in an hour. At night, my scalp was itching all nite. My scalp was red on the right side only which was the site of the vaccine. It is now 2 days later; the itching is gone but scalp has red blotches although they have faded at lot.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Metoprolol 25 mg QD,None,Hypertension,Rash at site with vaccine injections with thimerosal.,Drinking alcohol. I experience the Asian Flush Syndrome.,"['Erythema', 'Nausea', 'Palpitations', 'Peripheral swelling', 'Pruritus', 'Rash macular']",1,PFIZER\BIONTECH,IM 917044,TX,65.0,M,"Strong headache, tired",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,PVT,"Turmeric, zinc, probiotics, krill oil",,,,,"['Fatigue', 'Headache']",1,MODERNA,SYR 917045,CA,50.0,F,"8 days later developed some fullness and itching at injection site, no redness or warmth",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,01/01/2021,8.0,PVT,Losartan Levothyroxine,None,Hypertension Hypothyroidism,,NKDA,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 917046,UT,19.0,F,"I got the vaccine sometime in the afternoon and felt fine for the 15 minutes after the time of injection. I returned to work afterwards, and later that evening I started to feel chills, but it wasn't severe to the point where I went home. When I returned home from work, the chills remained but I also felt extremely exhausted which was unusual for me. I also had a bit of a headache/felt lightheaded. I took Tylenol which somewhat helped the symptoms. I felt fine after going to bed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,Multivitamins,None,None,,None,"['Chills', 'Dizziness', 'Fatigue', 'Headache']",1,MODERNA,IM 917047,FL,59.0,F,"High injection site left deltoid resulted in moderately severe left shoulder joint pain, weakness and reduced range of motion causing reduced ADLs for 10+ days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/21/2020,3.0,PVT,"Synthroid, Activella, Baclofen, Exalgo, etodolac, Vagifem, Viibryd, vitamin D3, fish oil, B12, Senna, biotin, Colace, turmeric, resveratrol, Tylenol, Vivrin",None,"Occipital neuralgia, cervical arthritis, depression, menopause",,Shrimp,"['Asthenia', 'Injected limb mobility decreased', 'Injection site joint pain', 'Loss of personal independence in daily activities', 'Product administered at inappropriate site']",1,PFIZER\BIONTECH,SYR 917048,PR,55.0,F,"Local pain and swelling with tightness from left side of neck down to elbow beginning the day of injection. The next day, generalized fatigue, malaise, and arthralgias in all joints, mainly in those already affected with OA. These symptoms improved 2 days after injection, though there is still pain and some swelling of injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,OTH,"Armour Thyroid, Rythmol, Finasteride, Hormonal replacement, MVT",,"Hypothyroidism, Supraventricular tachycardia, menopause",,none,"['Arthralgia', 'Fatigue', 'Injection site pain', 'Injection site swelling', 'Malaise', 'Muscle tightness', 'Pain', 'Swelling']",UNK,MODERNA,IM 917049,KY,33.0,F,"Headache 3 hours post injection. Started feeling body aches within 6 hours. Got home and took off scrubs to find swollen hard injection site, very hot to touch. Had to take off work the next day due to severe muscle aches and lethargy. That night had fever of 102.4 and chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,Lithium 1200mg CBG &CBD Levothyroxine 175mcg,COVID-19 Bronchitis,Hypothyroidism Bipolar disorder Congenital heart,"Influenza vaccine- redness, swelling and heat at injection site for 2 weeks. Now take preservative-free with no complications",Wellbutrin Polysorbate 80,"['Chills', 'Headache', 'Impaired work ability', 'Injection site induration', 'Injection site swelling', 'Injection site warmth', 'Lethargy', 'Myalgia', 'Pain', 'Pyrexia']",1,MODERNA,IM 917050,NY,37.0,F,"Patient developed a 8cm round erythematous and raised mark at the site of the injection, which lasted two days and resolved completely. It is now 8 days later, and she woke up today with a 6-7cm round erythematous, indurated mark at the same site, AS WELL AS an extreme fatigue so that she could not wake up this morning, and continued to fall asleep throughout the morning. Since this afternoon she has been feeling herself. The recurred erythematous mark at the injection site remains.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/01/2021,8.0,PVT,None,None,None,,None,"['Fatigue', 'Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Somnolence']",UNK,MODERNA,IM 917051,IL,53.0,M,At 8pm on 123120 my left arm along with various other sites of my body were in pain. I also developed a bad headache at that same time. I still have the headache almost 24 hours later.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,Lisinopril 5mg 1xd; levothyroxine 100mcg 1xd; amitriptyline 25mg 1xd,120320 tested positive for covid19,Hydrocephalus- numerous shunt surgeries.,,Compazene,"['Headache', 'Pain', 'Pain in extremity']",1,MODERNA,SYR 917053,AZ,32.0,F,"Headache, Fever, Body Aches, Nausea, Chills, Asthenopia, fatigue for 36 hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,"Nature Throid, PRN De3, Magnesium Easy Stick",,Hypothyroid,,NKDA,"['Asthenopia', 'Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917054,UT,51.0,F,"Fever, nausea, swelling, body aches, headache, chills, fatigue, back ache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PUB,Lisinopril 20 mg levothyroxine 50 mg adderall xr 20 mg adderall 10 mg,None,High BP over weight,,Nut allergy bee allergy,"['Back pain', 'Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Swelling']",1,MODERNA,IM 917056,NY,28.0,F,"tachycardia, nausea, itchiness, tongue swelling (voice change)==> all lasted from 1920pm to 2050pm. Given Benadryl IV and NaCl. Pt in the ER about 2.5 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,PVT,None,,Arnold Chiari Malformation,,"Spinach, Mango, Erythromycin","['Dysphonia', 'Nausea', 'Pruritus', 'Swollen tongue', 'Tachycardia']",UNK,PFIZER\BIONTECH, 917057,CA,39.0,F,"About 45 mins to an hour of receiving the vaccination , i felt a terrible pounding headache, I took Tylenol ES 500mg after felt relief but decided to sleep early. When I woke up this morning my injection site arm felt so painful and heavy and i had fevers between 103-101.5 though I took some tylenol 500mg every 6 hours. Tachycardic between 140-120bpm, i still have terrible headache, muscle & joint pains, extreme fatigue. Some dry cough but no shortness of breath.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,OTH,,None,,,,"['Arthralgia', 'Cough', 'Discomfort', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site reaction', 'Myalgia', 'Pyrexia', 'Tachyarrhythmia']",1,PFIZER\BIONTECH,IM 917058,TN,32.0,F,Moderna COVID19 vaccine EUA: Significant right arm pain improved with Tylenol and ibuprofen. Almost resolved in 2 days. Hives and itching started the morning after the injection and worsened throughout the day. Hives started on right arm and spread to whole body. Improved with Benadryl and anti-itch cream. Not completely resolved but greatly improved over night.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Zyrtec, singular, cranberry",None,None,Tetanus and tdap: rash And swelling in 2002 and anaphylactic In 2010,"Demerol, tetanus","['Pain in extremity', 'Pruritus', 'Urticaria']",1,MODERNA,IM 917059,CA,42.0,F,Vaccination was given on December 25 on January 1 started noticing redness and itching us at the vaccination site like a hive I just took Zyrtec will continue to monitor,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/25/2020,01/02/2021,8.0,PVT,None,No e,None,,Lots of hay fever,"['Injection site erythema', 'Injection site pruritus']",UNK,MODERNA,IM 917060,IL,28.0,M,Moderate pain on right side of mandible onset ~48 hrs after injection. Pain only experienced during flexion and extension of mandible such as yawning or chewing. No pain experienced when mandible is still. Symptoms are ongoing and currently present,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PHM,"Fluoxetine, bupropion, mydayis",None,"Major depression dx 10 yrs, Attention deficit disorder dx 5 yrs",,Cefaclor,"['Pain', 'Pain in jaw']",1,PFIZER\BIONTECH,SYR 917061,UT,26.0,F,"Fatigue, headache, low grade fever",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/31/2020,2.0,PVT,"Lamictal, Zoloft, klonopin, restoril",None,None,,None,"['Fatigue', 'Headache', 'Pyrexia']",1,MODERNA,IM 917062,MN,40.0,F,"Injection site swelling, redness, warm to touch, mildly tender that did not start until today-11 days after injection. I had none of the above directly after or in the 48 hours after the injection. There was absolutely no tenderness to injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,01/01/2021,11.0,WRK,"Metformin,vitamin b,invokana,glyburide, vitamin c, vitamin d with k2, celexa, singulair, allegra",None,"Diabetes, mild intermittent asthma, seasonal allergies, depression",Injection site swelling of 8inx6in after influenza vaccination>10 years ago,"Latex, kiwi","['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 917063,IL,58.0,F,"Face flushing about 30 minutes after vaccine followed by torso rash -- noticed on day after, which totally cleared by third day post-vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None,None,None,,None,"['Flushing', 'Rash']",1,PFIZER\BIONTECH,SYR 917064,PA,40.0,F,"The soreness in my arm from the shot was about 1 hour in. Within 24-26 hours I started to have nausea and vomiting with chills. 30 hours in I was still vomiting, my joints are sore, and a throbbing headache. Had to call off from work. 36 hours extreme fatigue and headache remained. 48 hours in fatigue and light headache. Still feel nauseated and arm soreness. Now have soreness in armpit.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PVT,None,None,None,,None,"['Arthralgia', 'Axillary pain', 'Chills', 'Fatigue', 'Headache', 'Impaired work ability', 'Nausea', 'Pain in extremity', 'Vomiting']",1,MODERNA,SYR 917065,OH,37.0,F,"Exactly 1 week after the vaccine, my arm started to itch very suddenly and badly right at the injection site. It was very red and bumpy; my arm, in that same area, was swollen and hard to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/31/2020,7.0,PVT,Loestrin 24-Fe Vitamin D Zinc,,,,ceclore (hives? - I was a baby),"['Cellulitis', 'Hypersensitivity', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling']",1,MODERNA,SYR 917067,LA,48.0,F,Severe pain in left shoulder developing approximately 24 hours after injection. Treated with ibuprofen 600mg TID x 2 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PUB,"allopurinol, lisinopril, gabapentin, prazosin",None,"HTN, gout",,"NKDA, NKFA",['Injection site pain'],1,MODERNA,IM 917068,MT,60.0,M,"Awoke with nausea and myalgias. Nausea and myalgias progressed. Fever and chills within a few hours. Very weak and fatigued. Myalgias became severe. Severe rigors and fever >102 about 26 hours post vaccine. Fever, myalgias, anorexia, nausea lasted approximately 30 hours. I felt like I had COVID all over again (I had it in July).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,Aspirin Carvedilol Rosuvastatin Melatonin Clopidogrel Vitamin D,,CAD,,,"['Asthenia', 'Chills', 'Decreased appetite', 'Fatigue', 'Myalgia', 'Nausea', 'Pyrexia']",UNK,MODERNA,IM 917069,CA,41.0,F,"Metallic taste in mouth, right side of tongue tingling/slightly numb",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,None,No,No,,"Amoxicillin, levaquin","['Dysgeusia', 'Hypoaesthesia oral', 'Paraesthesia oral']",1,MODERNA,IM 917070,MT,42.0,M,"Chills, unbearable headache, fever, sweating and lower back kidney area pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,simvastatin,none,High Cholesterol,,"Sulfa Drugs, Amoxicillin and General Anesthesia","['Back pain', 'Chills', 'Headache', 'Hyperhidrosis', 'Pyrexia']",1,MODERNA,IM 917071,VT,37.0,F,Instant swelling of deltoid. Decreased within 20 minutes. Pain at injection site and bruising after.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Melatonin at HS,None,,,She?ll fish,"['Immediate post-injection reaction', 'Injection site bruising', 'Injection site pain', 'Muscle swelling']",1,MODERNA,IM 917072,MD,37.0,M,"Nausea and headache mild beginning 5 hours after vaccine. Then in middle of night, moderate nausea, chills, fever, moderate muscle and body aches and moderate headache. These moderate issues continued throughout day after vaccine. Motrin and Tylenol helped a lot.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,SCH,Vitamin D Vitamin C,"COVID first symptom 12/20/20 (11 days prior to vaccine) symptom free for about 4 days prior to vaccine. This is my issue- I should have been told to wait longer (I think). I asked and was told as long as no symptoms, you?re fine. Maybe people should be told to wait longer between infection and vaccine???",None,,NKA,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,SYR 917073,CT,27.0,M,32 hours after my vaccination I fainted. When I came to my body felt weak and heavy and I felt like I could not move my limbs. It took about 45 min before I felt strong enough to get up off the floor and into my bed,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,"Cryselle, amitriptyline, diclofenac, tylenol",,Asthma,,Cephalosporin,"['Asthenia', 'Limb discomfort', 'Syncope']",1,MODERNA,SYR 917074,PA,30.0,F,"Headache, sore throat, fatigue, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,"Lexapro 20mg, buspirone 20 mg",None,None,Flu,None,"['Fatigue', 'Headache', 'Myalgia', 'Oropharyngeal pain']",1,MODERNA,SYR 917075,MA,66.0,F,"I woke up in the middle of the night to an ache in upper left arm with itching. On examination I saw a slightly raised red welt about 3 inches in diameter. i went back to sleep and in the morning woke with slight body aches and lethargy, welt on arm still there. My temperature has been low grade (99.2) . Still feeling lousy and arm is still inflamed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/01/2021,8.0,OTH,"Lisinopril, Omega 3, calcium, multivitamin, vitaminD",None,None,,Reglan,"['Inflammation', 'Injection site pain', 'Lethargy', 'Malaise', 'Pain', 'Pruritus', 'Pyrexia', 'Skin reaction', 'Sleep disorder', 'Urticaria']",1,MODERNA,SYR 917076,UT,28.0,F,Severe dizziness and headache the day after the shot.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,Tylenol Prenatal Fenugreek Lectithin,,,,Penicillin,"['Dizziness', 'Headache']",1,MODERNA,SYR 917078,TX,52.0,F,"10MINS AFTER THE VACCINATION LEFT SIDED FACIAL NUMBNESS . HIGH B/P 172/112 O2 SAT 98% HR 72, RR18. ANXIETY. SMILE SYMETRICAL PROTRUDING TOUNG CENTERED. @10:45AM B/P 153/93 @10:58 AM B/P 146/89 @11:15AM EMERGENCY SERVICES WERE OFFERED SEVERAL TIMES BY RPH ( PATIENT REFUSED) . PCP WAS NOTIFIED BY FNP - B C . MEDICAL DIRECTOR DR SPOKE TO PATIENT OVER THE PHONE DIRECTLY. NO PARLYSIS WAS DETERMINED. PATIENT COULD FEEL A PINCH IN THE AFFECTED AREA. PATIENT STATED THE REACTION ABATED BEFORE THE END OF THE CLINIC @12:30PM",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,SEN,PLAQUENIL- PREDNISONE- HIGHBLOOD PRESSURE MEDICATIONS,,SYSTEMIC LUPUS ERYTHMATOSUS/ HYPERTENSION,,METHOTREXATE,"['Anxiety', 'Discomfort', 'Hypoaesthesia', 'Protrusion tongue']",1,PFIZER\BIONTECH,IM 917079,MI,51.0,F,"2? diameter red welted area, around injection site, that is hot and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,OTH,"Buspar 30 mg bid, cymbalta 60 mg qd",,,,PCN,"['Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Injection site warmth', 'Urticaria']",1,MODERNA,SYR 917080,,46.0,F,"March 3,2020 patient received Restylane filler in tear troughs under eyes. 48 hours following COVID vaccine filler under right eye became swollen, painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PVT,,,,,,"['Facial pain', 'Swelling face']",UNK,MODERNA, 917081,TX,39.0,F,"Within 12 hours, red/indurated tender nodule at vaccination site. Now on day 8 post-vaccine, I now have a 5x4 cm indurated, pruritic, erythemic, hot lesion that is growing. I?m an MD And do not feel this is cellulitis but am surprised this itchy lesion is continuing to grow/itch. I have photos of the progression if you?re interesting in seeing. I need to know if after this I should still get dose 2. Thank you.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,PVT,Allegra,None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Skin lesion', 'Vaccination site induration', 'Vaccination site nodule', 'Vaccination site pain']",UNK,MODERNA,IM 917082,WI,43.0,F,"Began to feel tired and sore around 1530, chilled and feverish around 1730. Took temp at that time at 99.2� F. Muscle aches, joint pain, chills, tired and unable to move from couch, and dizzy. At 1830 temp up to 101.7� F, took 1000mg Acetaminophen. At 1840 temp up to 102.6�F before coming back down. It is now 2050, with 99.0� F with muscle and joint pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,PVT,Adderall 20 mg XR,,None,,Pork PCN,"['Arthralgia', 'Chills', 'Dizziness', 'Fatigue', 'Mobility decreased', 'Myalgia', 'Pain', 'Pyrexia']",1,MODERNA,IM 917083,NJ,54.0,F,"Injection site was very sore and little swollen. Unable to rest that pm due to discomfort, felt tingling in hand. Temperature started about 4am with stomach discomfort. 6:30 am Temp was 99.9, began having headaches and body aches along with dizziness. Temperature went up to 100.1. Hands were cold and clammy. Took Tylenol throughout the day, missed work due to not feeling well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,Lipitor 10 mg,None,None,,"Allergies to seafood, shellfish, pecans, almonds","['Abdominal discomfort', 'Body temperature increased', 'Cold sweat', 'Discomfort', 'Dizziness', 'Headache', 'Impaired work ability', 'Injection site pain', 'Injection site swelling', 'Malaise', 'Pain', 'Paraesthesia', 'Peripheral coldness']",1,MODERNA,SYR 917084,NC,66.0,F,"Pain, soreness at injection site, flushed feeling.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/01/2021,2.0,SEN,,,"SCHIZOAFFECTIVE DISORDER, BIPOLAR TYPE",,NKA,"['Hot flush', 'Injection site pain']",1,PFIZER\BIONTECH,IM 917085,IN,35.0,F,"Within the first 15 minutes of receiving the vaccine I was was extremely tired. As time went on, this seemed to subside. Tiredness has appeared to come and go over the last few days. Every morning I have woken up with tingling in my left hand, as though there are pins and needles in my left hand. My left arm feels weaker and feels some numbness when more pressure is placed on it. I have a bruise that appeared above my left wrist. I have reached out, as this is my employer and I have not heard back. Assuming they were closed due to New Year?s Day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/01/2020,,WRK,"Topiramate, Fluoxetine, Viibryd, Metformin, Iron, Vitamin D, Spironolactone, L-Methyl Folate, Simstatin",,Polycystic Ovarian Syndrome,,Sulfa,"['Contusion', 'Fatigue', 'Hypoaesthesia', 'Muscular weakness', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 917086,WI,51.0,F,"Severe fatigue, Gi upset, nausea, near syncope",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/27/2020,1.0,PVT,Prempro Escitalopram,None,Hot flashes,,None,"['Abdominal discomfort', 'Fatigue', 'Nausea', 'Presyncope']",UNK,MODERNA,IM 917087,NC,47.0,F,"Significant fatigue 24 hours after injection. Brain fog, need to sleep. Next am felt better Left arm discomfort for week Day 4 after vaccine- nausea, mild congestion no fever Day 6 after vaccine mild congestion and significant headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/28/2020,1.0,PUB,Mvit Ocp Zyrtec Zoloft,None,Hyper mobility,,None,"['Fatigue', 'Feeling abnormal', 'Headache', 'Limb discomfort', 'Nausea', 'Respiratory tract congestion', 'Somnolence']",UNK,PFIZER\BIONTECH,IM 917088,NC,74.0,F,"Lethargic, not eating",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,SEN,,,DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE,,"Imitrex, Neurontin, Pulmicort Flexhaler, Penicillins, Tape","['Decreased appetite', 'Lethargy']",1,PFIZER\BIONTECH,IM 917089,MI,33.0,F,"Persistent nausea x48 hours, so far. Half dollar size red, warm, swollen area at injection site since 12 hours post injection. No fevers.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,WRK,Lexapro 10mg,None,Back pain. Depression.,,None,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Nausea']",1,PFIZER\BIONTECH,IM 917090,TX,59.0,F,"DIZZY, ANXIOUS, BILATERAL HAND TINGLING AND NUMBNESS. B/P149/68 @10:45 B/P 128/62 PATIENT STATED SHE FEELS FINE 20MINS AFTER THE EVENT.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,SEN,,,ASTHMA- HDL- hip impingement,,DOXYCYCLINE- NAPROSYN,"['Anxiety', 'Dizziness', 'Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 917091,,41.0,F,"Moderate redness, swelling And tenderness at injection site. Welt-like. Entirety of day 2 after vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,WRK,"Insulin, levothyroxine, pitavastatin, spironolactone",None,Diabetes (T1) Hashimoto?s thyroiditis,,Nkda,"['Injection site erythema', 'Injection site pain', 'Injection site reaction', 'Injection site swelling', 'Urticaria']",1,MODERNA,IM 917092,OK,38.0,M,"DRY TONGUE, RACING HEART, ITCHY MOUTH, PALE COLOR TO LIPS AND FACE. 150/89, 97.7, 100.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,UKN,UKN,UKN,,UKN,"['Oral pruritus', 'Pallor', 'Palpitations', 'Tongue dry']",1,PFIZER\BIONTECH,IM 917093,MA,58.0,F,"Nausea, vomiting, severe fatigue, body aches and pains, low grade fever ,chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,UNK,None,None,None,,None,"['Chills', 'Fatigue', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 917095,OK,45.0,M,"LEFT HAND NUMBNESS, FEELS DIFFERENT. 97.8, 118/77, 80",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,UKN,UKN,UKN,,UKN,"['Feeling abnormal', 'Hypoaesthesia']",1,PFIZER\BIONTECH,IM 917096,IL,27.0,F,"Started to have soreness in the left arm the day after with body aches the next day (12/30). Then developed low grade fever up to 99.9F, chills, and body aches on 1/1/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,WRK,"Tri-sprintec, albuterol inhaler, zinc, probiotic, and multivitamin",,Exercise-induced asthma,,,"['Chills', 'Exposure to SARS-CoV-2', 'Pain', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 917097,OK,51.0,F,"ITCHING OF EYES AND LIPS. 97.6, 130/76, 81. 25MG BENADRYL GIVEN PO. 0909 STATES NO MORE S/S PER PT.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,UKN,UKN,UKN,,UKN,"['Eye pruritus', 'Lip pruritus']",1,PFIZER\BIONTECH,IM 917098,OK,31.0,F,"C/O STUFFINESS IN EARS, 97.6, 122/88, 69.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,UKN,UKN,UKN,,UKN,['Ear congestion'],1,PFIZER\BIONTECH,IM 917099,MT,39.0,F,developed pruritic erythematous plaque at injection site on L upper arm on day 8 after receiving vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/01/2021,8.0,PVT,Zyrtec,,,,NKDA,"['Injection site erythema', 'Injection site plaque', 'Injection site pruritus']",1,MODERNA,IM 917101,GA,29.0,F,Intermittent runs of tachycardia accompanied with dyspnea and diaphoresis. Symptoms began approximately 6 hours after receiving vaccine and has persisted.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,Balcoltra Docusate Sodium Miralax,,PCOS Endometriosis,,NKDA,"['Dyspnoea', 'Electrocardiogram', 'Hyperhidrosis', 'Tachycardia']",2,PFIZER\BIONTECH,IM 917102,NJ,61.0,F,"Injection site soreness, fatigue, nausea, generalized aches, low grade fever experienced within a few hours after administration. Self-limiting; no treatment necessary except rest. Soreness persisted for 2 additional days. The other symptoms resolved within 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,none,none,none,,none,"['Fatigue', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 917103,LA,70.0,F,Site initially sore then bicep becomes hard On the first of January bicep area becomes extremely red and very warm to touch,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/01/2021,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 917104,NC,41.0,F,"Approx 1 week following injection #1 of series, noted a rash/cellulitic area at the injection site. This area has gotten progressively larger over the past 48-72h.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/30/2020,6.0,PVT,"levothyroxine, Singulair, Zyrtec, omega-3 fatty acid supplement, docusate, probiotic supplement, cholecalciferol, collagen supplement",none,"asthma, hypothyroid, hyperlipidemia",,Sulfa (hives),"['Injection site cellulitis', 'Injection site rash']",1,MODERNA,IM 917105,OK,62.0,F,"REACTION OCCURED 8 MINUTES AFTER VACCINE, CHEST TIGHTNESS, FLUSHED AND DIAPHORETIC, 97.9, 165/83, 77. 25MG BENADRYL GIVEN.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,UKN,UKN,UKN,,UKN,"['Chest discomfort', 'Flushing', 'Hyperhidrosis']",1,PFIZER\BIONTECH,IM 917106,IL,59.0,F,"13/31/2020 Left arm soreness, swelling, red and hot 5:24pm. 01/01/2021 2:23 am I woke up to with severe headache and chills, about 1:20 pm I started having Body aches, my joints were hurting, I was having chills again and my headache just kept getting worse, with fatigue. I fell asleep about 1:30 for almost three hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,WRK,hydrochlorothiazide dosage 25mg,None,None,Flu shot,None,"['Arthralgia', 'Chills', 'Erythema', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Somnolence']",1,MODERNA,SYR 917107,OK,48.0,F,"C/O ITCHINESS, NO REDNESS NOTED, 50 MG BENADRYL GIVEN. 154/92, 93, REDNESS TO NECK APPEARING AT 0924. 0938 NO NEW S/S, NECK REDNESS REDUCING.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,UKN,UKN,UKN,,UKN,"['Erythema', 'Pruritus']",1,PFIZER\BIONTECH,IM 917108,NY,45.0,F,"At hour 30, fever of 101.4, resolved with tylenol. Mild soreness at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,Synthroid oral Breo inhaler,None.,"Hypothyroidism. Asthma. Hx of Covid illness (tested positive, fever) in March-April 2020.",,None.,"['Injection site pain', 'Pyrexia']",1,MODERNA,IM 917109,GA,55.0,F,"Projectile vomiting accompanied by uncontrollable diarrhea that lasted for 24 consecutive, HELLISH hours...",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,None,None,None,,None,"['Diarrhoea', 'Vomiting projectile']",1,MODERNA,IM 917110,MO,40.0,F,"Swollen lymph nodes in neck, arm, and chest. Sore Throat, fatigue, headache. Lymph nodes swollen on right side after one week of injection. Bilateral swelling of lymph nodes by day nine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/30/2020,8.0,PVT,"Lexapro, Imitrex",none,Osteoarthritis,,Sulfa,"['Fatigue', 'Headache', 'Lymphadenopathy', 'Oropharyngeal pain']",1,PFIZER\BIONTECH,IM 917111,UT,46.0,F,"Following the vaccine I was slightly dizzy, after 25 minutes my chest started to get tight, had difficulty breathing, racing heart rate, some constriction in the throat. I was taken to the ER, used Proair inhaler on the way to ER to ease breathing, O2 sat slightly decreased but returned to normal in the ER. Due to difficulty breathing, I had some increased anxiety which lessened after breathing became easier. Nebulizer treatment given in the ER. Benadryl 25mg taken. Rash on L arm and upper chest, burning and pain in L arm. Benadryl taken for 2 days due to returning rash and burning in arm. Nebulizer treatments every 4 hrs on the day of the vaccine due to continued tightness and difficultly breathing. The following day I had fatigue, slight fever, pain of 7 out of 10 in L arm, headache, neck and muscle pain. Followed up w/ primary care physician on 12/29/2020, he advised not to take the 2nd dose of vaccine. L arm pain lessened to 4 out of 10 on 12/30/2020. L arm pain dissipated on 12/31/2020, but headache, neck pain and fatigue continued through 1/1/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"Pentasa, Omeprazole, Loratadine, Tizanidine, Budesonide, Symbicort, One a day multivitamin, Probiotic, Tylenol",,"Crohns, Asthma",,"Morphine, Codeine, Penicillin, Aspirin, Sulfa, Bees","['Anxiety', 'Blood test', 'Burning sensation', 'Chest discomfort', 'Dizziness', 'Drug screen', 'Dyspnoea', 'Fatigue', 'Headache', 'Myalgia', 'Neck pain', 'Oxygen saturation decreased', 'Pain in extremity', 'Palpitations', 'Pyrexia', 'Rash', 'Throat tightness', 'Urine analysis']",1,MODERNA,IM 917112,MD,38.0,M,"Modern a COVID-19 Vaccine EUA. Left arm where administered had about a Golf ball size bump starting about 8 hours after administration as well as a 7/10 pain by palpitation and 4/10 pain with movement. At about the 10 hour mark symptoms started with GI issues, fever and sweats, rapid heart rate and general malaise. Day 2 continued with the GI issues 5/10 arm pain with the golf ball size lump remaining but adding a second bump right at the injection site. GI issues subsided by day 3 but general malaise continued and finally subsiding and a 1/10 pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,UNK,None,None,None,,NKDA,"['Gastrointestinal disorder', 'Heart rate increased', 'Hyperhidrosis', 'Injection site mass', 'Injection site pain', 'Injection site swelling', 'Malaise', 'Pain', 'Pyrexia']",1,MODERNA,IM 917113,CO,55.0,F,"Developed hard, warm, red , slightly raised area over my Right deltoid. Obvious injection hole in center of raised area.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/30/2020,6.0,PVT,"Vitamin D, wellness vitamin,",None,Mild asthma,,"One incident with shrimp. Ragweed on allergy test in childhood,","['Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 917114,CA,48.0,M,Two days after injection I began having a severe headache lasting 7 days as I write this. I was evaluated at an ER and released but the headache has been constant with minimal response to treatment.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/26/2020,2.0,PVT,Zoloft,None,Depression,,None,"['Angiogram normal', 'Computerised tomogram head normal', 'Headache', 'Lumbar puncture normal', 'Scan with contrast normal']",1,MODERNA,IM 917115,WV,72.0,F,"Following administration of vaccination, the patient was reported to have experienced a drop in blood pressure within 15 minutes of the vaccination. BP was reported by the nurse to be 80/50. Patient was alert and reported feeling well despite the hypotension. The patient was placed under further observation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,12/27/2020,0.0,OTH,,,,,,"['Blood pressure decreased', 'Hypotension']",1,MODERNA,IM 917116,NY,24.0,M,"Start 12/31/2020 tired, muscle tightness in upper back between shoulder blades, more energy, feeling more focused, tiredness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PVT,Tylenol,None,Heart mermer,,Dairy,"['Fatigue', 'Muscle tightness']",UNK,MODERNA,SYR 917117,AR,82.0,M,"After vaccination, patient tested positive for COVID-19. Patient was very ill and had numerous chronic health issues prior to vaccination. Facility had a number of patients who had already tested positive for COVID-19. Vaccination continued in an effort to prevent this patient from contracting the virus or to mitigate his risk. This was unsuccessful and patient died.",Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/28/2020,6.0,SEN,"Quietapine, Mertazipine, Hydrocodone, Fentanyl",Yes,Yes,,None,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",1,MODERNA,IM 917118,KY,55.0,F,"Within 24 hours of receiving the vaccination at her place of employment, the patient reported low grade fever and vomiting.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,12/28/2020,1.0,OTH,,,,,,"['Pyrexia', 'Vomiting']",1,MODERNA,IM 917119,WA,48.0,F,"Extreme left arm pain, left arm burning pain, traveling pain up to the neck, headache, low grade temperature for 3 day..left arm still very sore on day 4",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,None,None,None,Influenza vaccine,"Eggs, sulfa medications, penicillins, pineapple, ancef","['Burning sensation', 'Headache', 'Neck pain', 'Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 917120,WV,49.0,F,"Within 24 hours of receiving the vaccination at her place of employment, the patient reported fever, chills, and body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,12/28/2020,1.0,OTH,,,,,,"['Chills', 'Pain', 'Pyrexia']",1,MODERNA,IM 917121,MS,28.0,F,Fever. Chills. Dizziness. Hip Pain. Flank Pain. Joint Pain. Headache. Shivering. Nausea. Diarrhea. Weakness. Fatigue. Times 3 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,Paxil Protonix D3 B12,NONE,NONE,,Penicillin Gluten,"['Arthralgia', 'Asthenia', 'Chills', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Flank pain', 'Headache', 'Nausea', 'Pyrexia']",1,MODERNA,IM 917122,NY,35.0,M,"A little over ab hour after receiving the vaccine I noticed a burning sensation in my sinuses. By 130am 1/1/2021 I awoke from my sleep terribly dizzy, shaking violently and experiencing a fever of 101.3 F. I took advil and tylenol and fell asleep about an hour later. I woke up with similar symptoms at approximately 830am on 1/1/2021 took an additional dose of advil and tylenol and slept till 12p. I woke up with a bad headache and coughing fits similar to when I had covid back in March. I went to an urgent care who assessed me and ordered me to the ER. medical center administered IV fluids, an inhaler, steroids, epinephrine and benadryl and a few hours later my symptoms had subsided for the most part and a dose of IV antibiotics was administered. I am currently admitted for observation with likely discharge on 1/2/2021.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,12/31/2020,12/31/2020,0.0,PVT,"Networking, Januvia, amlodopine, losartan",None,"Crohns disease, diabetes, high blood pressure, sleep apnea",,None,"['Blood gases', 'Blood test', 'Burning sensation', 'Chest X-ray', 'Computerised tomogram', 'Cough', 'Dizziness', 'Headache', 'Pyrexia', 'SARS-CoV-2 test', 'Tremor']",1,MODERNA,SYR 917123,HI,41.0,F,"Nausea, slight headache, tenderness around the area I received the shot",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,None,None,Hypothyroidism,,Penicillin,"['Headache', 'Injection site pain', 'Nausea']",UNK,MODERNA, 917124,NM,42.0,F,"about an hour and a half after my shot Wednesday 12/30/20, I became extremely dizzy, it hit me suddenly. Lasted for a few hours. 12/31/20 when I woke up, I was still light headed and slightly dizzy and I still feel the same 1/1/20 dizziness is not nearly as bad as the first day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,Synthroid Losartan,Nonr,Thyroid Cancer- last occurrence 3/2011,,None,['Dizziness'],1,PFIZER\BIONTECH,SYR 917125,AZ,46.0,F,"Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated blood pressure. She reports getting the COVID-19 vaccine this morning, and after having been given the vaccine developed elevated blood pressure, palpitations described as ""her heart feels hot"", shortness of breath, a diffuse rash, and some generalized numbness. Patient called EMS after her symptoms did not resolve on their own, who gave her 50mg of IV Benadryl and transported her to the ED. Received solumedrol and famotidine IV in ED. Erythema noted on neck �",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"candesartan 8 mg daily, metformin 500 mg twice daily, pravastatin 40 mg once daily",,"Diabetes mellitus, hypertension , hyperlipidemia",,No known allergies,"['Blood pressure increased', 'Dyspnoea', 'Erythema', 'Hypoaesthesia', 'Palpitations', 'Rash']",1,PFIZER\BIONTECH,IM 917127,MA,33.0,F,"Mild swelling with redness near injection site first noticed 9 days after vaccine was administered. Area is about 2in x 3in, warm to touch, no itchiness, pain, or soreness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/31/2020,9.0,PUB,OTC multivitamins,,,,"N/A, NKDA","['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 917130,,32.0,F,Left axillary swelling/lymphadenopathy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,Multivitamin,"Rhinovirus,enterovirus",None,,None,"['Lymphadenopathy', 'Oedema peripheral']",1,PFIZER\BIONTECH,IM 917131,SD,37.0,F,"Injection site rash and itchiness, started ~1 week after receiving vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/29/2020,6.0,WRK,"Atorvastatin, Sprintec, paroxetine, cholecalciferol, multivitamin",None,"Anxiety, hyperlipidemia",,None,"['Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 917132,NJ,34.0,F,"Chills, fatigue, muscle aches, fever with period of sweats, swollen neck lymph nodes, dizzy, diarrhea, pounding headache. Symptoms have started to occurr on 12/28, until now jan 1st, 2021. It consumes my whole body, to eve. Get up from bed or even walk 10ft to the bathroom. Its very difficult, I am a single mom with 3 kids.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/28/2020,7.0,PVT,None,None,None,,None,"['Chills', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Lymphadenopathy', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 917133,MD,50.0,F,"Extreme tiredness started 30 minutes after vaccination into the day after. Chills, pain at the injection site, headache, tiredness day after vaccination. Took Motrin 600 mg which relieve headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,MIL,None,None,Migraine,Flu vaccine 2 years ago standard dose,Latex penicillin sulfa benzoyl salicylic acid,"['Chills', 'Fatigue', 'Headache', 'Injection site pain']",1,PFIZER\BIONTECH,IM 917134,IA,51.0,F,"Rash with itching, fast heartbeat, shortness of breath, fever for 4 days. Benadryl 50mg given po at 1600.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,PVT,"Warfarin, Pravastatin, Atorvastin, Levothyroxin, Cymbalta, Vitamin D, Vitamin E, Topamax, Peri Colace",None,"Asthma, hypothyroidism, migraines, Antiphosolipidantibody syndrome.",,"PCN, Sulfa, Cleocin, Ancef, Cipro, Vancomycin, Latex","['Dyspnoea', 'Heart rate increased', 'Pyrexia', 'Rash pruritic']",1,MODERNA,IM 918563,OH,49.0,F,"dizziness, headache, body aches (heaviness)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,none,none,none,,none,"['Discomfort', 'Dizziness', 'Headache', 'Pain']",1,MODERNA,IM 918694,AK,23.0,F,"12/24/2020 chills body aches headache, fever off and on. onest pain, shortness of breath",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/24/2020,1.0,WRK,,,,,,"['Chills', 'Dyspnoea', 'Headache', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 917136,OH,20.0,F,"Tachycardia with a heart rate in the 120-140s, fever, fatigue, muscle weakness, joint weakness, and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,No,None,No,,No,"['Arthropathy', 'Fatigue', 'Headache', 'Muscular weakness', 'Pyrexia', 'Tachycardia']",1,MODERNA,IM 917137,,49.0,M,"Strong chills, with uncontrollable and vigorous shaking and teeth chattering",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,WRK,Duloxetin,,,,,"['Chills', 'Tremor']",1,MODERNA,IM 917139,VA,44.0,F,Fever chills severe myalgia headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/28/2020,7.0,PVT,None,None,None,Serum sickness w hep b vaccine at age 20,Bactrim macrobid Serum sickness after hepatitis b vaccine,"['C-reactive protein increased', 'Chills', 'Full blood count normal', 'Headache', 'Influenza virus test negative', 'Metabolic function test normal', 'Myalgia', 'Pyrexia', 'Red blood cell sedimentation rate normal', 'SARS-CoV-2 test negative', 'Serum ferritin increased']",UNK,PFIZER\BIONTECH, 917141,NJ,32.0,F,"Middle of the night woke up shivering, chills, fever, bones ached, could not even lift my arm it was so sore and under armpit. Symptoms lasted all day. Next night woke up out of sleep symptoms even worse. Next day same symptoms but now a hard ball that hurts formed near clavicle on side of vaccinated arm. Arm, armpit, clavicle area on right side now all hurt.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,Lexapro 5mg,None,None,,None,"['Axillary pain', 'Bone pain', 'Chills', 'Induration', 'Mobility decreased', 'Pain in extremity', 'Pyrexia', 'Sleep disorder']",1,PFIZER\BIONTECH,IM 917142,TX,65.0,F,Diarrhea for 3 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,Lisinopril 20mg qd,None,Hypertension,,None,['Diarrhoea'],UNK,PFIZER\BIONTECH,IM 917143,TX,56.0,M,"At around 7pm on 12/31/2020 I started having severe shakes and fever by around 11pm, the fever was 104. I took 6 Tylenols and 4 Advils. By around 4am on 01/01/2021, my fever had stopped. At around 5pm on 01/01/2021, I started having low grade fever again and I took 2 Advil and I'm okay now",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Vitamines, Anti Acid, Cholesterol Med, Aspirin, Naproxen",Knee Pain,High Cholesterol,,NKDA or No Food Allergies,"['Pyrexia', 'Tremor']",1,MODERNA,IM 917144,OH,37.0,F,"Day 1 the medicine burned going in , arm hurt really bad , day 2 swelling and redness, and itching, headache, fatigue, pain in my neck, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,"Effexor, birth control",None,None,,Singular,"['Erythema', 'Fatigue', 'Headache', 'Nausea', 'Neck pain', 'Pain in extremity', 'Pruritus', 'Swelling']",1,MODERNA,SYR 917145,TX,62.0,F,"within 5 minutes of injection patient complaining of severe Left lower back pain / muscle cramp/spasm. Possibly slight rash to upper ext. Patient seemed in shock. Patient given 1mg Ativan, and within 10 minutes of laying down she became much more calm. No histamine blockers/steroids/epi was required. Possible adverse reaction vs hyperventilation/muscle spasm. Within 2 hours patient able to be discharged safely.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,losartan,none,HTN,,None,"['Back pain', 'Electrocardiogram normal', 'Muscle spasms', 'Shock']",UNK,MODERNA,IM 917147,IA,27.0,F,"Swelling, hardness, warmth, and pain at injection site in left arm. Also major swelling and pain in lymph nodes on left side of body.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,None,None,None,,No known allergies,"['Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 917148,,36.0,M,Patient vaccinated with first series of moderna covid19 vaccinator on 12/27/20. He had had a close case contact with someone on 12/25 who later became symptomatic and covid19 posits He developed congestion starting 12/30. No other symptoms. These symptoms are ongoing,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/27/2020,12/30/2020,3.0,OTH,,,,,,"['Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,MODERNA,IM 917149,CA,40.0,F,Nausea/ vomiting 2.5 days after first dose,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,Lexapro,None,Depression,,Chlorhexidine,"['Nausea', 'Vomiting']",1,MODERNA,SYR 917150,,42.0,F,"The injection arm was sore within 1 hr of vaccination. The soreness was then spread to the shoulder, then in the middle of night, I was awaken with whole body muscle aches that similar to flu. The next day, the aches were subsided but I felt tired and sleepy with sore arm the entire day. I went to sleep early and lasted for 11 hrs (something that is unusual for me).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,UNK,hydroxychloroquine,,SLE,,Keflex,"['Fatigue', 'Hypersomnia', 'Influenza like illness', 'Injection site pain', 'Myalgia', 'Pain in extremity', 'Sleep disorder', 'Somnolence']",UNK,MODERNA, 917151,NM,60.0,F,Patient had an asthma attack about 10 minutes after the dose was given while waiting in the post-vaccination area.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,PHM,unknown,Asthma,,"Pneumovax 15 years ago, had a similar reaction","aspirin, penicillin,Versed, nickle,nylon,milk,cinnamon oil","['Asthma', 'Condition aggravated']",1,MODERNA,IM 917152,CA,59.0,F,"Got positive, testing for CoVid 19 on,12/30/2020. Symptoms started gradually on 12/19/20 w/ sore arms, fatigue then started getting brain fog , HA, body aches until current. my MD and I thought it was due to vaccine. Then add loss of taste and appetite on 12/30/20 along with rest of symptoms. I knew then I needed to get swab. Symptoms is still current.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/20/2020,2.0,PVT,none,none,asthma,influeza vaccine,"amoxicillin, clindamycin","['Ageusia', 'Decreased appetite', 'Fatigue', 'Feeling abnormal', 'Headache', 'Pain', 'Pain in extremity', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,SYR 917153,,22.0,F,"Began to have mild headache, mild tiredness, and mild chills on 12/28. Followed up with PCP who advised that the symptoms should resolve in a few days.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/28/2020,2.0,PVT,,,,,,"['Chills', 'Fatigue', 'Headache']",1,PFIZER\BIONTECH,IM 917154,OK,41.0,F,"Random heart palpitations, tachycardia, mild chest tightness and occasional fatigue. Started five days post COVID Pfizer vaccine. Symptoms strikes at random times. No prior health issues.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/28/2020,5.0,PVT,Women multivitamins,None,None,,"OxyContin , seasonal Allergies","['Chest discomfort', 'Fatigue', 'Palpitations', 'Tachycardia']",1,PFIZER\BIONTECH,SYR 917155,WA,40.0,F,"Terrible dizziness, lightheaded, overall feeling like something isn?t right in my body almost a nervousness ,chest pain, tingling to right hand and right side of my head, also have nausea, headache unrelieved by Tylenol or ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,PUB,"Ibuprofen, Tylenol, multivitamin, calcium, mag, iron, b complex, niacin, fiber",None,"Asthma, HTN,",,None,"['Chest pain', 'Dizziness', 'Nausea', 'Nervousness', 'Paraesthesia']",1,MODERNA,IM 917156,KS,45.0,F,"Injection site was warm to the touch on 12/31/2020. There is also a small knot felt under the skin but nothing shows on the skin. Intermittently, the entire muscle itches but there is nothing to scratch. After a few (3-4) ?scratches? the feeling subsides.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/31/2020,10.0,PUB,Cetirizine 10mg Fexofenadine 180mg Metformin 1000mg Toprol XL 100mg Lisinipril-Hctz 10-12.5mg Ferrous Sulfate 325mg Vitamin D 50mcg Vitamin C 500mg Zoloft 150mg Zocor 40mg Flonase 50mcg Bydureon 2mg,None,Diabetes,,Tide/Gain cleaners Preparation H,"['Injection site nodule', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 917157,NY,61.0,F,"Chills,low grade fever, fatigue,body ache,generalized body malaise,sore throat,severe headache,nausea,difficulty of breathing,shortness of breath,congestion,runny nose and severe headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,Stielto Respimat and Pulmicort Inhaler,None,COPD,,NKA,"['Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Malaise', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'Respiratory tract congestion', 'Rhinorrhoea']",1,MODERNA,IM 917158,TN,54.0,F,"Within 24 hours of receiving vaccine, I became very dizzy , had severe weakness, nausea, severe headache, muscle and joint pain, chills, fever (temperature-102.8),and exhaustion. Redness, pain, and swelling at injection site that has continued to worsen even after 48 hours. Could not perform regular activities of daily living. I could not drive home from work the day after the injection because the adverse reactions were getting more severe, especially after the 24 hour mark. Treatment: treated my symptoms at home with medications (I am a nurse), after researching possible adverse reactions. I figured there was not anything someone else would to treat me besides treat my symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,"Thyroid, lisinopril/hctz, vit, D, multivitamin, alpha lipoic acid, cymbalta, mobic, protonix, Gabapentin.",Recovered from covid. Tested positive on December 2nd.,"History of thyroid cancer with thyroidectomy (2007), HTN, degenerative disc disease, CRPS/RSD.",,"Insect stings/venom, environmental allergies","['Arthralgia', 'Asthenia', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Impaired driving ability', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Loss of personal independence in daily activities', 'Myalgia', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917159,HI,21.0,M,"Fever, fatigue, congested nose, dry eyes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,UNK,none,none,none,,penicillin,"['Dry eye', 'Fatigue', 'Nasal congestion', 'Pyrexia']",1,MODERNA,SYR 917160,AZ,31.0,F,Left lower lobe Pneumonia with small pleural effusion,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/27/2020,4.0,SCH,"Daily fiber, daily prebiotic, vitamin D, daily Protonix",None,None,,Macrobid and Morphine,"['Angiogram', 'Chest X-ray', 'Electrocardiogram', 'Pleural effusion', 'Pneumonia']",1,PFIZER\BIONTECH,IM 917161,CA,48.0,F,"Fever, chills, body aches for one day. Took only Tylenol 650mg 6 hrly.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,UNK,,,,,,"['Chills', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 917162,TX,41.0,F,"Left sore arm at site 48 hours, dizzy, headaches, fast heart rate average 104-115 x 2 days, 3-5 days headaches and neck ache, neck stiffness, neck pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,None,None,hypertension,,None,"['Dizziness', 'Headache', 'Heart rate increased', 'Musculoskeletal stiffness', 'Neck pain', 'Pain in extremity']",1,MODERNA,SYR 917163,AL,57.0,F,"Site getting continually redder, hotter, itchier and thicker over time now with darker red center,sore lump and too painful to scratch. 4 cm dia. induration.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,"Adderall, wellbutrin, seroquel, armour thyroid, atenolol, losartan, prilosec, metformin, buspirone, naproxen, fish oil, calcium, glimipramide, zyrtec, lamictal, viamin d, zaleplon",None,"Diabetes, low thyroid, hypertension, GERD, ADHD, Bipolar",,Adhesive tape,"['Injection site erythema', 'Injection site induration', 'Injection site mass', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 917164,WA,47.0,F,"At 4 minutes post vaccine injection, uncontrollable tremors, nausea, dizziness, shortness of breath/tightness to chest, hyperventilation, extremely cold hands, uncontrollable crying. Symptoms lasting approximately 1-2 minutes. At 9 minutes post injection - all symptoms repeated lasting for 1-2 minutes. Admitted to the ED 20 minutes post injection for observation. No treatment necessary, discharged 2 hrs post injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Zyrtec, Goodies Headache Powder",none,"Chronic Migraine, Chronic Rhinitis, Chronic Sinusitis, Raynaud's Phenomenon, Seasonal & Perennial Allergies",,"Uncooked Apples, Uncooked Cherries, Cashews","['Chest discomfort', 'Crying', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Hyperventilation', 'Nausea', 'Peripheral coldness', 'Tremor']",1,MODERNA,IM 917165,RI,64.0,F,Headache at 4 pm that night but went away after 2 advil. Started with chills and body aches during the night and then fever. Took Advil with little effect. Temp went up to 38.8 by next 24 hours with continued body aches. Continued with Advil. Fever never went below 38 for next 24 hours. but then started to go down along with body aches. Tired 3 days later temp down to normal.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,asa amlodipine atorvastatin metoprolol isosorbide lamotrigine cranberry supplement ginkgo biloba Vd3 fish oil zetia,,Hyperlipidemia Hypertension,,amoxicillin sulfa dynacin,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 917166,AR,38.0,F,"Redness, swelling, itching and significant pain at injection site that has gotten worse over the last 24 hrs. Full body aches, feeling feverish but no fever, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,MIL,Gabapentin Ibuprofen Aspirin Fioricet,None,Insomnia Migraine,,Muenster cheese- anaphylaxis as a child.,"['Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Pain', 'Pyrexia']",1,MODERNA,IM 917167,GA,53.0,F,"After injection left arm was sore x2 days and then was fine. On 1/1/21, site felt warm to the touch, swollen and sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/01/2021,8.0,PUB,"Amoxicillin, Jardience, probiotics, multivitamin, Metformin, Lisinopril, Rosuvastatin, Aspirin, Pregabalin, Vitamin D, Estradiol/Norethindrone",None,"Type 2 Diabetes, High blood pressure, high cholesterol, Common Variable Immune Deficiency",,Sulfa,"['Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 917168,NJ,64.0,F,"10:03Throat felt like going to closing like after other reaction to rocephin. 10:05Swallowing ability felt like going to be difficult. 10:06 Immediately to ER from vaccination area at hospital. 10:10 Then coughing from bronchospasm lasting over a minute repeating until ER meds kicked in . Meds- solumedrol 125 mg IV , Benadryl 50 mg IV , xophenex 1.25 nebulizer",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Tylenol,None,"GERD , hypertension, bronchospasm reactive airway",,Rocephin Morphine,"['Blood creatinine increased', 'Bronchospasm', 'Condition aggravated', 'Cough', 'Differential white blood cell count normal', 'Dysphagia', 'Full blood count normal', 'Glomerular filtration rate decreased', 'Metabolic function test', 'Throat tightness']",1,MODERNA, 917169,OH,30.0,F,"12/31 8:30am noticed maculopapular erythematous rash mostly on torso (few lesions on extremities), itchy scalp, and mild edema/erythema at RT corner of bottom lip. Also had mild pain on ball of RT foot, thought I had stepped on something. 1:30pm woke up with severe edema of bottom lip, rash also on scalp next to ears 3pm seen at urgent care, received and filled prednisone prescription 4pm lip edema started improving, so did not end up taking the prednisone 8pm lip edema gone, erythema and mild edema to DIP joint and tips of fingers, all fingers of LT hand and RT pinky. All hand joints and wrists sore. Soreness to toes and heels while walking but not at rest. Applied ice to fingers, then turned up heat. 1/1 3-4am finger edema/erythema totally resolved 8am foot pain starts resolving 5pm still with mild wrist pain, mild foot pain. Rash evolving -- most lesions improved but some have coalesced, new lesions on neck Never any fever, checked x2, Tmax 99.0F. Did not end up taking any medications since my symptoms seemed to be resolving. Only other possible recent exposures were a new lotion tried 12/27 (but only applied to face, was careful to keep it away from my lips, and I did not have any rash on my face except the swollen lip) and a new dress that I did not pre-wash (but I had few lesions on my arms which would have also been exposed).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PVT,Levothyroxine 75mcg 1 tab Mon-Sat 0.5 tab Sun Aliskiren 150mg 0.5 tab BID Spironolactone 25mg 0.5 tab daily Enalapril 2.5mg 1 tab BID LoSeasonique 1 tab daily (continuous) Zyrtec 10mg 1 tab daily Calcium carbonate 1200mg daily Vitamin D 200,"12/20 -- had about 8h vomiting/diarrhea, possibly food poisoning",Unrelated bone marrow transplant 12/1990 for aplastic anemia Primary amenorrhea likely 2/2 total body irradiation received as part of transplant induction Hypothyroidism 2/2 thyroidectomy for thyroid cancer (2004) Hypertension Seasonal/environmental allergies Vitamin D deficiency Magnesium deficiency,"Approximately 7 yo had full body hives with flu shot, did not receive it after that. Allergy tested in medical school in prepara","Ketoconazole -- hypernatremia Caines -- flushing/tachycardia Flu shot -- hives at age 7, thought to be 2/2 given subcutaneously inadvertently. Negative skin test, but did have rash at site 8-12h later. Have gotten multiple doses (IM, inactivated vaccine) since without reaction","['Arthralgia', 'Erythema', 'Lip erythema', 'Lip oedema', 'Oedema peripheral', 'Pain in extremity', 'Pruritus', 'Rash', 'Rash erythematous', 'Rash maculo-papular', 'Skin lesion']",1,MODERNA,IM 917170,MI,29.0,F,"States she started feeling a bit of a headache after leaving the observation area, and by the time she got to her office in the same center, she had light sensitivity. Has not taken any medications no known allergies. Headache described as pulsating located in the front of her head. States relief when eyes are closed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,,,,,,"['Headache', 'Photophobia']",1,PFIZER\BIONTECH,IM 917171,NY,26.0,F,"Hardness and pain at injection site until present (5 days+), fever for 2 days starting day after administration",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,Tamiflu,"['Injection site induration', 'Injection site pain', 'Pyrexia']",1,MODERNA,IM 917172,MI,55.0,F,"Employee developed some anxiety, heart racing and tingling in her lips. this resolved on its own after 10 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,,"denies, but states normally runs a little higher on heart rate.",,,PCN,"['Anxiety', 'Palpitations', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 917173,IN,58.0,F,"Patient with history of fear of needles and anxiety experienced dizziness, nausea, and an abnormal tongue sensation ~5 minutes after receiving the vaccination. Patient denied any treatment or further follow-up (paramedics and/or ER). Vitals 148/70, HR 74.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,OTH,"Gabapentin, acetaminophen PRN, anxiety and anti-depressants (names unknown)",,Anxiety,,"Wheat, PCN, opioids, NSAIDs","['Dizziness', 'Nausea', 'Paraesthesia']",1,MODERNA,IM 917174,MA,25.0,F,"Chills- was occasional, not associated with any fevers. Happened multiple times a day until 12/27/2020 in AM then subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,WRK,Daily oral combination birth control pill,,,,,['Chills'],1,MODERNA,IM 917175,NH,43.0,F,"The day following injection, my arm was sore, I felt tired. These symptoms went away by day 3. Then on 12/31 day 8, I noticed my arm was sore again. It became red, swollen, hot to touch, itchy, and sore. I marked the area. I called my PCP on 1/1/21, She recommended I keep an eye on it, as I have no fevers nor do I feel sick, that it is likely a delayed immune response. 1/2/21- the redness has spread beyond markings but is less swollen and sore. Seems to be improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/31/2020,8.0,WRK,"Synthroid, multivitamin, collagen, calcium, vit D, Pepcid complete",None,Exercise induced asthma mild GERD,,None,"['Erythema', 'Fatigue', 'Pain in extremity', 'Pruritus', 'Skin warm', 'Swelling', 'Tenderness']",1,MODERNA,IM 917176,NJ,61.0,F,None,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/01/2021,01/02/2021,1.0,PVT,None,,None,,None,['Unevaluable event'],1,MODERNA,SYR 917177,MI,55.0,F,Employee states pain in left shoulder down into chest and lightheadedness but the symptoms resolved within 15 minutes.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,,,,,,"['Arthralgia', 'Chest pain', 'Dizziness']",1,PFIZER\BIONTECH,IM 917178,ME,30.0,F,"A few Moments after receiving the vaccine, I was sitting down reading a book when I became hot head to toe and my heart began beating fast, hard without variance. My watch alerted me that my heart rate was 168. I walked over to the pharmacist at this time. I lid down and they check my Blood pressure which was 116/63. After the excitement in my heart subsided I had nausea extreme nausea with dry heaves.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Zinc, vitamin d, B12",None,None,,Penicillin,"['Feeling hot', 'Heart rate increased', 'Nausea', 'Retching']",1,MODERNA,IM 917179,NY,24.0,F,"First day about 4-5 hours after: severe chills and headache Day 2: woke up in morning with left eye completely swollen, both ears swollen, congestion, and productive cough",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Junel-Fe,None,None,,penicillin,"['Chills', 'Ear swelling', 'Eye swelling', 'Headache', 'Productive cough', 'Respiratory tract congestion']",1,MODERNA,IM 917180,MD,52.0,F,"Modern a COVID-19 vaccine EUA Soreness, swelling, painful to touch at injection site - started a couple of hours after injection, still present 48 hours post Dizziness about 5 hours later - rested for about 15 minutes until it subsided. Drank water.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,PVT,None,None,None,,,"['Dizziness', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 917181,VA,57.0,F,"chill, fever (102F), cough, body ach, pain in injection site, loss of taste",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PVT,none,none,hypercholesterol,,none,"['Ageusia', 'Chills', 'Cough', 'Injection site pain', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 917182,AL,66.0,F,Fever. Pain muscle aches body aches. Leg pain altered sense of taste fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PUB,Cozaar. Vascepa. Multi vitamin calcium. Delzicol,None,Hypertension. Arthritis. Migraine. Ulcerative colitis anterior uveitis,,Depakote,"['Fatigue', 'Myalgia', 'Pain', 'Pain in extremity', 'Pyrexia', 'Taste disorder']",1,MODERNA,IM 917183,TX,68.0,F,"Woke up during night after getting the vaccine with Chills, fever, achy- Took Tylenol about 6:30 am . Fever came down., but returned. 6 hrs later I took ibuprofen and within 2 hours I begin to feel better. By 7:30 PM on Jan 1st I felt normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PUB,"Antihistamine, vitamin C, vitamin D",,,,,"['Chills', 'Pain', 'Pyrexia', 'Sleep disorder']",UNK,MODERNA, 917184,MI,40.0,F,"Employee complained of palpitations and feeling warm for approximately 15 minutes, symptoms resolved on their own. employee is 14 weeks pregnant.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,,,,,Fish/fish derived products,"['Exposure during pregnancy', 'Feeling hot', 'Palpitations']",1,PFIZER\BIONTECH,IM 917185,FL,66.0,F,"Severe dizziness to the point I was unable to walk or even sit without fear of passing out or falling and had to lay on the floor. Rapid heart rate, nausea, felt like blood pressure was going up a lot. Afraid I was on the verge of having a stroke. Symptoms hit abruptly with no warning. Were severe for about an hour and then started subsiding. Gradually felt better over the course of a couple of hours. After about 6 hours, symptoms completely gone and I felt fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,UNK,"Rosuvastatin, ezetimibe, Valtrex, carvedilol, pregabalin, low dose aspirin, vit d",None,"Heart disease, shingles",,"Brilinta, lisinopril","['Dizziness', 'Gait disturbance', 'Heart rate increased', 'Nausea']",1,MODERNA,SYR 917186,CT,35.0,F,"Fever 102 for 2 days, chills, headache, nausea,golf ball sized lump at injection site and bruising",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,OTH,None,Had stitches 3 weeks prior in finger with tetanus shot in right arm,"Obesity, new pre-hypertension",,"No, none","['Chills', 'Headache', 'Injection site bruising', 'Injection site mass', 'Nausea', 'Pyrexia']",1,MODERNA,IM 917187,TN,58.0,M,"I received the *Pfizer-BioNTech Covid-19 Vaccine EUA*. I was already not feeling my best that morning symptoms of warmness at home no fever , I checked. No issues with vaccine given approximately 0715, until 1005 am after a very busy morning with nothing but coffee to drink. As I sat down to assist in order entry in our chemo clinic I suddenly became aware of a very rapid heart rate. I realized that I was having a vaso-vagal response and started perspiring lightly and realizing I was having drop in blood pressure. I composed myself removed my mask and breathed slowly and drank cold water while sitting. After a few minutes I was able to slow my heart rate and felt secure enough to leave the pharmacy. I slowly walked and controlled my breathing and continued to drink water. I was able to return to work and continued until the end of the day. I felt somewhat fatigued until bedtime that evening. Slept reasonably well that night and had no other symptoms to my memory the following day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,"losartan 50 mg q am, pantoprazole 40mg q am, cyanocobalamin 1000mcg po q am, folic acid 0.4mg a jam, simvastatin 20mg q hs, famotidine 40mg q hs, magnesium glycinate 400mg q hs","Symptoms of sinus infection, congestion, some drainage, mild cough and recent diagnosis of EHEC (enterohemorrhagic e.coli.).","rheumatic fever as a child, HTN, mild sleep apnea, elevated cholesterol, silent GERD",,"PCN, anaphylaxis","['Blood pressure decreased', 'Fatigue', 'Heart rate increased', 'Hyperhidrosis', 'Presyncope']",UNK,PFIZER\BIONTECH, 917188,AL,64.0,M,"About 8 hours after injection, began to have flu like symptoms and they continually worsened into severe symptoms; body aches, fever, cough, tiredness. Took Tylenol for these symtoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"Tresiba, Metoprolol, Furosemide, Metformin, Ranolazine, Famotidine, Atorvastatin, Hydrochlorothizide, Ozempic, Humalog",,"Type II Diabetic, HTN, Chronic Bronchitis",,None,"['Cough', 'Fatigue', 'Influenza like illness', 'Pain', 'Pyrexia']",1,MODERNA,IM 917189,MO,42.0,F,"Lethargy, slight cough, sinus drainage, slight fever (98.5, when I normally run 96.8)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/01/2021,9.0,PUB,"Omeprazole, Escitalopram, Zyrtec, Cal-Mag, Vit D3, Vit B 12, Women's One-A-Day, Biotin, Turmeric, Burn, Burn PM",Seasonal allergies,Obesity,,"PCN, Augmentin, Aleve, Levaquin, Poison Ivy","['Cough', 'Lethargy', 'Paranasal sinus hypersecretion', 'Pyrexia']",1,MODERNA,IM 917190,TX,50.0,M,extremely Dizzy with chills and still dizzy after almost a week,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,PVT,lipiprosil (for blood pressure),None,High Blood pressure,,None,"['Chills', 'Dizziness']",1,PFIZER\BIONTECH,IM 917191,FL,74.0,F,Very bad rash / hives over entire body,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,OTH,"Atorvastatin, bupropion, levocetirizine, topiramate, escitalopram",,,,"Penicillin, sulfa","['Rash', 'Urticaria']",UNK,MODERNA, 917193,MA,48.0,F,patient has numbess of right side of face and felt swelling of the tongue. airway did not close. site staff gave Benadryl 25mg,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,,,,,,"['Hypoaesthesia', 'Swollen tongue']",1,MODERNA,IM 917194,VA,57.0,F,Noted itchy rash and skin sensitivity to back side of abdominal region on day 10 post vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/02/2021,10.0,PVT,Synthroid Estradiol Zinc Vitamin D,None,None,,None known,"['Rash pruritic', 'Sensitive skin']",1,MODERNA,IM 917196,OH,51.0,F,"Rash left arm, ill defined borders, started opposite of deltoid . Rash is red, raised, warm, tender to palpation, slight irritation/burning, rarely itches. Slowly progressing towards site of injection . 1/1/20 - two Aleve and applied Hydrocortisone 2.5 % lotion x 1 1/2/20 - No significant change except it seems to be slightly clearing in center with red raised borders.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,OTH,Venlafaxine 75 mg daily Alive Women's 50+ Multi Vitamin one tablet daily SR Collagen powder - one scoop daily,None,None,,Erythromycin,"['Burning sensation', 'Ill-defined disorder', 'Pruritus', 'Rash', 'Rash erythematous', 'Rash papular', 'Skin irritation', 'Skin warm']",1,MODERNA,IM 917197,PA,23.0,F,"Fever, chills, headache, dizziness. All lasted for about 24 hours. Was treated at home with Tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,Birth control,None,None,,None,"['Chills', 'Dizziness', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917199,AR,61.0,M,"Moderna COVID-19 Vaccine EUA ,,,,,eruption, pustule, area of right Axillary (pectoral) lymph node. Area of redness surrounds.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,OTH,"Metformin 1500 Mgs. Lisinopril 2.5 mgs. Vitamin C, Vitamin D, Adult multi. Ginkgo Biloba, Saw palmetto, Ginseng,",None,Diabetes II,"Flu vaccine two months ago, flu vaccine last year, blister on lip, both times...",None known,"['Lymphadenitis', 'Pustule', 'Rash']",1,MODERNA,IM 917200,CT,61.0,F,Little sore oon arm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/02/2021,1.0,UNK,"Vitamin D3 125mcg Vitamin A 2,400mcg Tylenol 600mg",None,None,,None,['Pain in extremity'],1,MODERNA,SYR 917201,TX,65.0,M,On the day after the vaccine was given I began to feel fatigued with chills and body aches. These symptoms lasted 18 hours. The next day I felt better but washed out. I received the shot in my left arm and it has remained sore for 4 days. A hand sized red rash developed on day 5 and is still evident on day 6. The site is still tender to touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,"Hydrochlorot 12.5, Atorvastatin 20, Eliquis 5mg x 2, Adult multivitamin. Vitamins a, b, c, d3. Calcium, Zinc, Bio-ten, Magnesium, Vision vitamins.",,Hypertension,,Penicillin,"['Chills', 'Fatigue', 'Injection site pain', 'Pain', 'Pain in extremity', 'Rash erythematous']",1,MODERNA,IM 917202,CT,58.0,F,"prolonged achiness in muscle, erythema 1cm X 3cm at injection site, extreme itchiness and warmth at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/29/2020,5.0,PVT,"Sertraline, Estrogen gel, MV, Vit. D, Fish Oil",None,Collagenous colitis,,"Penecillin, sulfa drugs","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 917203,MA,56.0,F,"very sore vaccine site, body aches, chills/sweats x 2 days starting 24 hours after vaccine fever up to 101 x 1 day started 24 hours after vaccine no appetite x 3 days fatigue x 3 days FYI- I did have COVID in September 2020",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Metformin, glimipiride, levothyroxine, atorvastatin, irbesartan, trulicity, humalog, lantus, vit D",none,"diabetes, hypothyroidism, hypertension,hyperlipidemia",,none,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Pain', 'Pyrexia', 'Vaccination site pain']",1,MODERNA, 917205,NY,58.0,F,"Moderna Covid-19 Vaccine EUA Arm pain at injection site, body and joint aches , chills, fever to 102.5, severe headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,Letrozole 2.5 mg,,,,"Latex, Bactrim, PCN","['Arthralgia', 'Chills', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 917206,CA,46.0,F,"Experienced dizziness, lightheadedness 1 hour post vaccine. Started to feel throat swelling on 12/18/20. Went to ED on 12/20/20. Not reported as serious adverse effect, but medical record labeled with moderate reaction. Diagnosis: vasovagal episode. Discharged stable.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/18/2020,0.0,PVT,,,,,NKDA,"['Dizziness', 'Electrocardiogram normal', 'Pharyngeal swelling', 'Presyncope']",1,PFIZER\BIONTECH,IM 917207,PA,31.0,F,"Enlarged and painful axillary lymph node on the left side (injection site side) lasting for 5+ days. Still occurring but slowly resolving. Two days later (1 week after vaccination) injection site red and swollen for 2 days, but has since resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/29/2020,5.0,PVT,None,None,None,,None,"['Injection site erythema', 'Injection site swelling', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 917208,CT,51.0,F,"Arm soreness, back pain, feeling tired and weak, lower back pain, arm and leg fatigue, pains in head but don't last. Some stomach pain. I work mostly 7 days a week so I have not been seen and assume that these symptoms will fade but wanted to report. No fever at this time. Just extreme exhaustion that comes and goes.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,OTH,125 Unithroid,"Lupus, hx of Lyme",See above,,"Levaquin, wine, some alcohol Champagne, (inconsistent reactions)","['Abdominal pain upper', 'Asthenia', 'Back pain', 'Fatigue', 'Headache', 'Pain in extremity']",1,MODERNA,SYR 917210,UT,30.0,F,"30YO F ICU nurse obesity (BMI 35) COVID 19 on Dec 2 symptoms, Dec 3 tested positive for COVID-19. never hospitalized, outpatient only. 12/12 completed isolation 12/21 received vaccine 12/7 developed Fever chills diarrhea SOB cough Urgent care visit. RLL consolidation on CXR given doxycycline 100 mg po bid worse, fever 40 targetoid lesions to LE (started before doxy) WBC 22K tachycardic tachypneic admitted requiring 2-4L oxygen CT angio without clot, diffuse ground glass and RML dense infiltrate DDimer 7.8 LDH 599 CRP 41 procal 0.67 ferritin 500 Viral respiratory PCR negative Sputum cx with oral flora (pending) COVID ag testing neg COVID PCR 1/3 targets positive (called as indeterminate).",Not Reported,,Yes,Yes,6.0,Not Reported,N,12/21/2020,12/27/2020,6.0,PVT,cyclobenzaprine 10mg po tid mirena 52mg IUD,"COVID-19 Dec 2 Not hospitalized, mild symptoms",Acne Depression Anxiety Obesity BMI 35,,NKDA,"['Blood lactate dehydrogenase increased', 'C-reactive protein increased', 'Chest X-ray abnormal', 'Chills', 'Computerised tomogram thorax', 'Cough', 'Diarrhoea', 'Dyspnoea', 'Fibrin D dimer normal', 'Lung consolidation', 'Lung infiltration', 'Lung opacity', 'Procalcitonin increased', 'Pyrexia', 'Respiratory viral panel', 'SARS-CoV-2 test negative', 'SARS-CoV-2 test positive', 'Serum ferritin increased', 'Skin lesion', 'Sputum culture', 'Tachycardia', 'Tachypnoea', 'White blood cell count increased']",UNK,PFIZER\BIONTECH,IM 917211,GA,38.0,M,Sore arm starting about 3 hours after injection and continuing for over 48 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PUB,Omeprazole Vitamin C Nasacort,None,None,Same flu shot,None,['Pain in extremity'],1,MODERNA,SYR 917212,FL,49.0,F,L axillary pain and mild lymphadenopathy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,PVT,Levothyroxine,None,Hypothyroid,,Minocycline,"['Axillary pain', 'Lymphadenopathy']",1,MODERNA,IM 917213,IL,28.0,F,"Fever, chills, headache, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,none,"miscarriage with vacuum extraction 12/29, uncomplicated",none,,allergy to Keflex,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917214,MA,50.0,F,"Ten minutes after vaccine administration, I experienced a tingling sensation at the injection site (left deltoid), which rapidly spread into the surrounding tissues, up my arm, and into my chest. My heart started to pound forcefully. I became tachycardic 110?s-120?s (my usual pulse is 60?s) and hypertensive 170?s-180?s/80?s-90?s (my usual BP is 100?s-110?s/60?s-70?s). I never felt faint or anxious. Approximately 20 minutes after vaccine administration my pulse came down to 100?s. I remained hypertensive. At one hour post-vaccine, my BP was 178/98. I was then transferred to the ED. At 90 minutes post vaccine my BP was 180?s/80?s and pulse was high 90?s. The BP gradually came down. I was discharged home three hours post-vaccine with BP of 140?s/80?s and pulse in the 90?s. The next morning, my VS returned to normal: BP 106/62, pulse 67.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Vitamin D 5,000U, 3x/ week Magnesium 200mg QD B-12, 1500mcg, 3x/weekly",None,None,,Sulfa - rash Propylene glycol - perioral dermatitis,"['Blood thyroid stimulating hormone normal', 'Electrocardiogram normal', 'Full blood count normal', 'Hypertension', 'Injection site paraesthesia', 'Metabolic function test normal', 'Palpitations', 'Paraesthesia', 'Tachycardia']",1,MODERNA,IM 917215,SC,62.0,F,"Elevated bp hours after vaccine along with sore arm. Next morning, muscle/joint aches, inability to ambulated, severe headache, brain fog, chills, shaking/trembling,pain all over. Evening of 1-2-2021, itching all over and hives on trunk.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,SEN,"Valsartan, paroxetine, loperamide, prempro, ambien, hydroxyzine,vitamin D3, align, Tylenol PRN, McIntyre,",Acute high blood pressure from covid,"Hypertension, IBS",,"Tagamet, losartan, nifedipine","['Arthralgia', 'Blood pressure increased', 'Chills', 'Feeling abnormal', 'Gait inability', 'Headache', 'Myalgia', 'Pain', 'Pruritus', 'SARS-CoV-2 test negative', 'Tremor', 'Urticaria']",UNK,MODERNA,IM 917218,GA,78.0,F,"My arm started feeling sore the evening of the injection day. I di not sleep well that night as slight chills and general achiness began. When I got of bed the following morning I felt so weak, woozy and light headed that I was afraid I would fall. I slept all day but by that evening I began feeling better and by the following day (day 2 after the shot) I felt normal except that my arm was still sore. It is now day 3 and my arm is still slightly sore but not limiting my use and is steadily getting better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,SEN,"Omeprozole, Red Rice Yeast, Calcium, low dose asperin, senior multi-vitamin, Omega 3 fish oil","had COVID 1 month, 7 days prior to vaccination. No other illnesses.",none,,sulfa,"['Asthenia', 'Chills', 'Dizziness', 'Insomnia', 'Limb discomfort', 'Pain']",1,MODERNA,IM 917219,IL,30.0,F,Paralyzing back pain Extreme bruising Flu symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/29/2020,10.0,PVT,Prenatals,None,None,,Penicillin,"['Back pain', 'Contusion', 'Influenza', 'Spinal X-ray']",1,PFIZER\BIONTECH,SYR 917221,FL,33.0,F,"45 minutes post vaccination, at my place of work, I got hives all over my body and my blood pressure became extremely high. It took two days of benadryl every 4 hours to get the hives to stop. No anaphylaxis.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Metformin , spironolactone.",,PCOS. Celiac disease.,,"Penicillin, amoxicillin, pyridium, cranberries, wheat",['Urticaria'],1,MODERNA,IM 917222,NY,64.0,F,"Body aches, fever less than 101, headache, nausea, lymphadenopathy, fatigue ,loss of appetite",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,Unithroid 88mcg daily Vitamin C 500mg daily Zinc 50mg daily Vitamin B complex daily MVI daily Vit D 5000mcg daily,none,none,,none,"['Decreased appetite', 'Fatigue', 'Headache', 'Lymphadenopathy', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917223,OH,37.0,M,"Chills, Nausea Last 15 minutes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,UNK,,,,,,"['Chills', 'Nausea']",UNK,MODERNA, 917224,RI,57.0,F,"Fever 101.2, body aches, joint pain, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,"Estradiol patch, Rosuvastatin, Omeprazole, Vitamin D, Calcium","Cough, congestion",Celiac Disease,,Wheat and Gluten,"['Arthralgia', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917225,GA,82.0,M,The injection site began to hurt the evening of the day of the injection. I did not sleep well that night and was generally achy and fatigued the next day. Additionally I had a very dry mouth . By that evening I began to feel better although I was still a little tired but by the next day began to feel normal. The injection site is still tender (day 3) but getting better.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,SEN,"KCL, pravastatin, allopurinal,finasteride, furosemide, clonidine, lisinopril, terazosin, metfromin, omeprazole, eliquis, carvedilol, amlodipine, latanoprost, omega 3 fish oil, me.atoin, vision shield, vitamin D","tested positive for COVID 19 one month, 7 days prior to vaccination.","Disected aeorta, type 3, descending, high blood pressure (controlled), diabetes (controlled), macular degeneration, atrial fibrillation (mild and not requiring treatment other than yearly check-up)",,sulfa,"['Dry mouth', 'Fatigue', 'Injection site pain', 'Insomnia', 'Pain']",1,MODERNA,IM 917226,CO,34.0,F,Burning and soreness instantly in left arm Development of nausea and headache by later that evening and into the next day. Also weakness in arm that the injection was done continuing in day 2.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Spironolactone,None,None,,Shellfish,"['Headache', 'Injection site pain', 'Muscular weakness', 'Nausea']",2,MODERNA,SYR 917227,NY,34.0,F,Headache and myalgia - headache developed within 3 hrs and lasted 1-2 hrs; resolved with Motrin. Myalgia developed within 12 hrs and lasted 48 hrs. Motrin and Tylenol were effective,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Headache', 'Myalgia']",1,MODERNA,SYR 917228,PA,62.0,F,12/31/2020 6 pm diarrhea resolved after 3 episodes. 1/12020 loss of smell and taste.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/01/2021,2.0,PVT,"Metformin 1000mg bid, Atorvastatin 40 mg daily, Fluoxetine 10 mg daily.",none,diabetes,,,"['Ageusia', 'Anosmia', 'Diarrhoea']",1,MODERNA,IM 917229,IN,30.0,F,"100 degree fever, body aches, sore under arm/armpit of left arm (injection arm), fatigue, nausea, slight headache, swollen lymphnodes",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,"daily vitamin, probiotic",na,na,,na,"['Axillary pain', 'Fatigue', 'Headache', 'Limb discomfort', 'Lymphadenopathy', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 917230,IL,47.0,F,tachycardia hypotension dizziness/lightheaded weakness nausea pre-syncope,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,multi-vitamin zinc vitamin d-3 valacyclovir,none,hashimotos,,demerol morphine azithromycin bee stings apples cayenne pepper,"['Asthenia', 'Dizziness', 'Electrocardiogram', 'Full blood count', 'Hypotension', 'Nausea', 'Presyncope', 'Tachycardia']",1,MODERNA,IM 917231,NE,25.0,M,"Fatigue, body aches and fever of 100.7",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PUB,None,None,None,,Seasonal,"['Fatigue', 'Pain', 'Pyrexia']",1,MODERNA,IM 917232,CA,63.0,F,"Pt woke up day after vaccine with itchiness on her chest, throughtout the day the itching did not go away. Woke up Wednesday with rash all over chest area. No rash elsewhere on body. Reported to employee health and was told to take benadryl and if rash continued to contact my primary care provider.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,multi vitamin,none,none,,none,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 917233,NY,54.0,F,"hard, red, swollen, hot, painful Left arm - area about 1 1/2"" x 2 1/2"" at injection site pain in left lymph node area- under arm",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/31/2020,2.0,PVT,"Prescription: Topiramate 50mg (2x/day), Monteluka10mg (1x/day) OTC: Migrelief, Tumeric, PreserVision (1 pill- 2x/day) OTC: MultiVit, D3(1000), C(500), fish oil (1000), Instaflex, {Zyrtec(am), xyzal(pm)}- per Dr orders",none,none,,none,"['Axillary pain', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 917234,WI,31.0,F,"Injection site soreness immediately after injection at 7am. General body aches progressed throughout the day. By 6pm same day all of the following: injection site pain, joint pain, muscle aches, fever>100deg, upset stomach, fatigue and mild headache. All symptoms lasted from 12/30 to 1/1. Fever peaked at 102deg.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Nuvaring, multivitamin, zinc supplement, calcium supplement, b12 supplement.",None,None,,Allergic to artificial garlic: migraines.,"['Abdominal discomfort', 'Arthralgia', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Pain', 'Pyrexia']",1,MODERNA,IM 917235,CT,60.0,F,"I felt ok after injection all the first day. During nigh had chills. Woke with right arm soreness, great fatigue and headache pain (6-9/10) not constant, nausea, vomited once. In bed all day w/ HA pain and fatigue. Next day felt much better without symptoms, just a bit of tiredness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,None,None,None,"Flu and Shingle; arm soreness, headache",none that I know of,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain in extremity', 'Vomiting']",1,MODERNA,IM 917237,AL,26.0,F,fever and headache 5 hours after taking shot. Fever and headache lasted roughly 30 hours. Three days after taking shot started to itch real bad and have hive like bumps. Currently still have itching bumps 4 days after shot,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,SEN,"Singular when needed, haven't taken it in a few months.","Sinus congestion, prior",Sinusitis,,,"['Headache', 'Pruritus', 'Pyrexia', 'Urticaria']",UNK,PFIZER\BIONTECH,SYR 917239,IL,33.0,F,Recipient reports itching to arms and neck approximately 25 minutes after receiving first dose of Moderna Covid-19 Vaccine. 50mg Benedryl IM administered to Right arm. Recipient held for observation following benedryl administration.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,None,None,None,,"Cipro, Penicillin",['Pruritus'],1,MODERNA,IM 917240,WI,42.0,F,"pfizer-Biotech/Covid-19 vaccine flu like symptoms- nausea, light headed, trouble focusing, stuffy nose, body aches, fever and chills but no actual fever- body just felt really warm. problems breathing at times (like a panic attack), headache, stiff neck, fatigue-- I fell asleep in my car because I was so tired. sore arm, irritability, When trying to lie down, I could not get comfortable, I found myself lying on the floor since it was cold, this is not normal behavior. i felt super sick. I was crawling on the floor because of how dizzy and tired i felt. It felt like a really bad drunk or hangover. noises were too loud, it felt horrible. I don't know if it is done.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,WRK,turmeric probiotic collagen ashwagandha acyclovir sertraline,,light sensitivity asthma maybe the start of arthritis in some places,,,"['Chills', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Headache', 'Influenza like illness', 'Irritability', 'Limb discomfort', 'Malaise', 'Musculoskeletal stiffness', 'Nasal congestion', 'Nausea', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 917241,CA,49.0,F,"12 hrs after vaccination, had mild frontal headache and fatigue. 24 hours after, itching, burning , stinging sensation around eyes, itchy forehead with mild erythema including eyelids, mild circumoral numbness with occasional burning/stinging sensation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,None,None,Pre-diabetic. Environmental allergies.,,"Tested for allergy in the past and was found to have environmental allergies - trees, pollen, dust","['Erythema', 'Eye irritation', 'Eye pain', 'Eye pruritus', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Pruritus']",1,PFIZER\BIONTECH,IM 917242,ME,40.0,F,"itching, redness, swelling, & warmth approximately 2"" around vaccination site, pain in left shoulder/arm, general fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/31/2020,7.0,WRK,"Bupropion SR, vitamin D3, vitamin B6, vitamin K2, vitamin C, magnesium",none,none,,none known,"['Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Pain in extremity', 'Vaccination site swelling', 'Vaccination site warmth']",1,MODERNA,IM 917243,NH,29.0,F,"Swollen lymph nodes, swollen Injection site, itchy injection site, hardness of injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,Mirena IUD,Abscess of jaw,"Lupus, obesity.",,Opiates,"['Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Lymphadenopathy']",1,MODERNA,IM 917244,MN,54.0,F,Hives/rash around torso.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,PUB,None,None,None,,None,"['Rash', 'Urticaria']",1,MODERNA,IM 917245,FL,39.0,M,"Vomiting, fever, headache,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/28/2020,1.0,PVT,"Lisinopril, Lipitor",None,None,,None,"['Headache', 'Pyrexia', 'Vomiting']",1,MODERNA, 917246,MA,43.0,M,Severe muscle pain inability to move arm has continued for 4 days and still going Swelling at injection site Lethargy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,SEN,,,,,,"['Injection site swelling', 'Lethargy', 'Mobility decreased', 'Myalgia']",1,PFIZER\BIONTECH,IM 917247,NC,63.0,F,"Moderna COVID-19 Vaccine EUA: Pain, itching, bruising, large blisters on the entire right arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,Unknown,None stated/noted,None stated/noted,,None noted,"['Blister', 'Contusion', 'Injection site bruising', 'Injection site pain', 'Injection site pruritus', 'Injection site vesicles', 'Pain in extremity', 'Pruritus']",1,MODERNA,IM 917248,TX,70.0,F,"A week after injection I developed a fairly large area (6"" long by 3"" wide) with erythemia, mild swelling, and accompanying pruritis, and with scattered petechiae around the injection site on my upper left arm. Still present three days later but resolving. It was not sufficient to cause any difficulty with my daily activities and did not require any medical intervention. I did apply 1% hydrocortisone cream with no significant effect. I just wanted to report it because this is a new vaccine, and I wanted to make sure any side effect was noted for research purposes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site haemorrhage', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 917249,OR,48.0,F,"Woke up w/ primarily left sided cervical lymphadenopathy with gum pain/swelling on the left - onset 12/27. Visit to dentist for worsening pain and mild body aches and chills - dentist felt the pain and swelling, + mild ulceration due to new toothbrush head causing abrasions on gums and hard palate - no treatment prescribed - 12/28. Worsening painful lymphadenopathy (now bilateral cervical), body aches, chills, joint pain, fevers, odynophagia, gum pain/swelling, malaise - visit to respiratory clinic - rapid strep negative; COVID negative, bacterial throat culture negative (VS: HR 120, SBP 168, T 100.7 on Tylenol) - no treatment prescribed - 12/29. Development of shallow, painful ulcers LEFT hard palate, gums and a RIGHT lip ulcer - 12/31. Photos of ulcers reviewed with previous dentist - prescribed acyclovir 400 mg TID and magic mouthwash. 12/31. Taking Ibuprofen and Tylenol regularly. As of today, 1/2, improvement in cervical lymphadenopathy, resolution of constitutional symptoms, and odynophagia. Ongoing mouth pain and ulceration. + left facial numbness/burning pain (V1-3) similar to previous episode of trigeminal neuralgia in 1999.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/27/2020,3.0,PVT,OCP,None,None,,Sulfa,"['Arthralgia', 'Bacterial test negative', 'Chills', 'Gingival pain', 'Gingival swelling', 'Hypoaesthesia', 'Lip ulceration', 'Lymphadenopathy', 'Malaise', 'Mouth ulceration', 'Odynophagia', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Streptococcus test negative']",1,PFIZER\BIONTECH,SYR 917250,CA,44.0,F,I developed facial rashes that is spreading down The rashes are painful to touch. Feels inflamed,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,Vitamin C Vintamin E Vitamin D3 Adult multi vitamin,None,None,,Penicillin Crab allergy,"['Inflammation', 'Rash', 'Tenderness']",1,MODERNA,IM 917251,,28.0,F,"Arm pain/soreness began about 8 hours after receiving vaccine, lasted for three days- was at it's worst morning after. Slight swelling and knot at injection site also occurred day after vaccine. Headache began morning after receiving vaccine, was off an on for three days. Lightheaded/fuzziness began two days after vaccine, lasted for 12 hours. Symptoms treated with ibuprofen and cold pack for arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,OCP,None,None,,,"['Dizziness', 'Feeling abnormal', 'Headache', 'Injection site nodule', 'Injection site swelling', 'Pain in extremity']",1,MODERNA,IM 917252,CA,45.0,M,"Swollen, reddish, sore left deltoid after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,Lisinopril 5 mg po qday,None,Hypertension,,None,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 917253,NC,37.0,F,Patient (physician) reported she developed shingles post-COVID vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,01/02/2021,14.0,WRK,None,None,None,,NKDA,['Herpes zoster'],1,PFIZER\BIONTECH,IM 917254,,54.0,F,"Body aches, fatigue, arm pain(first couple of days), diarrhea and nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,UNK,"Ramipril, zocor, estrace, Zyrtec, zanaflex, areds, contrave, omezaprol, melatonin, ibuprofen",Sinusitis,"HTN, scoliosis , hyperlipidemia",,Erythromycin,"['Diarrhoea', 'Fatigue', 'Nausea', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 917256,OR,92.0,M,Chills post day 2 and diarrhea post day 3. Both lasted less than a day,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/28/2020,2.0,OTH,Tylenol B 12 Preservision REDS Senna Vit D3 Calcium D Ferrous Sulfate MVI Melatonin,Infected toe,anemia PROSTATIC HYPERPLASIA MALIGNANT NEOPLASM OF PROSTATE HTN GERD,,Cephalexin Tetracycline,"['Chills', 'Diarrhoea']",2,PFIZER\BIONTECH,IM 917257,NY,55.0,F,chronic severe arm pain for over 3 months treated with advil and ice after an hour pain comes back,Not Reported,,Not Reported,Not Reported,,Not Reported,N,10/01/2020,10/07/2020,6.0,WRK,"metoprolol, metformin, advil, aromasin statin",none,"high blood pressure, diabetes, cholesterol",,none,['Pain in extremity'],,"SEQIRUS, INC.",IM 917258,WI,25.0,M,Extreame left arm pain. Tender to touch and movement. Unable to sleep at night due to discomfort and pain. Unable to lift arm above head due to pain level. Pain has not decreased at all.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PUB,"Vibrid, buspirone, omeprazole, ibuprofen, B12",Na,"High blood pressure, cluster migraines, anxiety, depression",,Na,"['Injected limb mobility decreased', 'Limb discomfort', 'Pain', 'Pain in extremity', 'Sleep disorder', 'Tenderness']",1,MODERNA,SYR 917259,FL,51.0,F,"Moderna COVID-19 Vaccine EAU Starting 12/31/20, 8 days following vaccine, large oval rash below injection site on right upper arm, raised, red, and warm, approximately 3 1/2 inch diameter oval",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PVT,"Aviane, multivitamin, Vit. E 400IU, St. John?s Wort 600 mg daily, fish oil 1000mg, niacinamide 500 mg 3x daily, Vitamin C 500 mg, Calcium plus vit D 600mg/D3 20 mcg, potassium iodide 150 mcg, probiotic",None,Granuloma Annulare Transient hyperthyroidism,,Sulfa Latex sensitivity,"['Injection site reaction', 'Injection site warmth', 'Rash erythematous', 'Rash papular']",1,MODERNA,IM 917260,GA,40.0,F,"Rash throughout scalp, face, neck, ears,torso,thighs,legs, arms, back, itchy throat and ears. Benadryl 50 mg Pepcid 40 mg Prednisone 60 mg The rash started after 1 hour. Took 25 mg benadryl then by 9 pm it got worse, took another 25 mg benadryl without improvement. Continue taking benadryl next day and took pepcid by 12 noon the next day. Following day 22nd December the patient went to hospital ER at 1200 noon. There got prescribed 60 mg prednisone PO with benadryl 50 mg and pepcid 20 mg. Received instructions to continue taking same dose for another 4 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,WRK,Tylenol 650 mg pain once Multivitamin Iron medication Vitamin D,"Infection, took flagyl 500 mg BID for 7 days completed medication prior to vaccination time.",Antiphospholipid syndrome Hyperlipidemia Migraines Anemia,,None,"['Ear pruritus', 'Full blood count', 'Metabolic function test', 'Pregnancy test urine', 'Rash', 'Throat irritation']",1,PFIZER\BIONTECH,IM 917261,IL,53.0,M,"Pain at injection site, myalgia, chills, fever,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,PUB,"Novolog (insulin pump) levothyroxine, atorvastatin",,"Insulin dependent diabetes, Hashimoto's thyroiditis",,,"['Chills', 'Injection site pain', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 917262,VA,76.0,M,Blistering burning rash opposite arm of injection site spreading down arm. Time 1 day after injection 24 hours later,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,MIL,"allopurinol, diclofenac, fluoxetine hcl, Janumet XR, Lipitor, Losartan, Ofev, Vit D3, Tumeric",None,"Idiopathic Pulmonary Fibrosis, Diabetes, HBP, Gout",,None,"['Blister', 'Burning sensation', 'Rash']",1,MODERNA,IM 917263,MA,62.0,F,"I noticed my left arm is swollen, red, warm to the touch, sometimes itchy on Dec 31,2020. Contacted via phone and e-mail, Occupational Health Services on 1/1/2021. I also saw an ED physician at on 1/1/2021 who said a local inflammation reaction was unlikely, probably cellulitis, and prescribed doxycycline. The affected area of my arm was marked to follow progression of red, warm area. Began doxycycline 1/1/2021. Next morning red, warm area of arm is now outside of marked area and down to below my elbow. I have an appointment with Occupational Health on Monday, January 4,2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PVT,none,none,"migraine headaches Goblet Cell Carcinoid 2019, appendectomy and right hemicolectomy 2019, no evidence of metastatic spread",,Cipro- makes me extremely nauseous,"['Cellulitis', 'Peripheral swelling', 'Pruritus', 'Skin reaction', 'Skin warm']",1,MODERNA,IM 917264,WI,33.0,F,Left arm pit. Swollen painful lymph node,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,01/02/2021,32.0,SEN,Viibryd 60mg q morning Cyclobenzaprine 2.5 mg q HS Clonazepam 0.5 mg q HS Birth control q morning Ibuprofen PRN,None,Depression Anxiety,,Niacin-itching,"['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 917265,OH,61.0,F,"Had redness and welt at injection site. Unmediated and arm sore for week. Redness and soreness leftwithin 5-6 Days. On day 8 injection site became red, raised, slightly warm and itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PUB,"Lexapro, eye vitamin, d3, alieve, bio flex, Claritin, anastazole, HCTZ, zinc, magnesium, omeprazole",None,"History of breast cancer, htn",,Sulfa,"['Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity', 'Urticaria']",1,MODERNA,IM 917266,NH,68.0,F,VERY SORE LEFT SHOULDER EVEN WHEN I LIFT MY ARM AND MY GLANDS ON MY LEFT SIDE OF NECK SORE NONE,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"tylenol,metoprolol,synthroid, calcium, vit d claritin",,"vertigo occ,",PNEUMONIA AND SHINGREX VACCINE JUST SORE ARM FEW DAYS,"pcn,keflex,asa,effexor, ,,,lobster,shrimpvomiting also vomiting from sulfa,emycin","['Injection site pain', 'Lymph node pain', 'Pain']",2,MODERNA,IM 917267,MD,35.0,F,"Moderate headache at night 12/30/20 Dry cough nonpersistent (AM), chills (PM) 12/31/20 Lost of taste/smell 01/02/21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PVT,"Vitamin B-complex, Vitamin C",,,,,"['Ageusia', 'Anosmia', 'Chills', 'Cough', 'Headache']",1,PFIZER\BIONTECH,IM 917268,NY,66.0,F,"Moderna COVID-19 Vaccine EUA fatigue,headache,chills,fever, aches tenderness at injection sight, pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,UNK,"Daily Vitamin, Prozac,Tegretol,Dexilant,baclofen",none,"Multiple sclerosis, osteoarthritis, Gerd,",,"Pennicillin, Sulfa,Macrodantin,","['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pyrexia']",1,MODERNA,SYR 917269,FL,22.0,F,"Fever, chills, muscle pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,"Vyvanse 40mg, Balcoltra birth control tablets",None,None,,Penicillin,"['Chills', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 917270,OH,55.0,F,"Sore arm at site of vaccine, body aches, headache, nausea, fever, chills , muscle soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,Daily Multi-Vitamin,None,None,,None,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Vaccination site pain']",UNK,MODERNA, 917271,FL,80.0,M,Nothing yet,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,UNK,,,,,,['Unevaluable event'],1,MODERNA,IM 917272,TX,30.0,F,"Wrist swelling - Intense pain while wrist was at rest, starting 2 says after the surgery. Pain dramatically decrease to tender the following day. Arm soreness - started a few hrs after injection. More intense pain and firmness at injection site the next day. Difficult to raise arm. Resolved the following day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PHM,Syeda Birth control,None,None,,None,"['Arthralgia', 'Injected limb mobility decreased', 'Injection site induration', 'Injection site pain', 'Joint swelling', 'Pain in extremity', 'Surgery', 'Tenderness']",1,MODERNA,IM 917273,TX,30.0,F,"Within 5 minutes of patient receiving the vaccine during her monitoring period, she complained of nausea and dry mouth, then dizziness; initial blood pressure 172/98, HR 126, RR 24 and O2 Sat 99% RA; activated EMS at 2:13pm; patient assisted to lie down on a cot, at 2:18 pm BP 142/88, HR 109, O2 sat 97%; c/o difficulty swallowing and feeling tightness in throat, no rash or hives seen; EMS arrived on site at 2:23 pm and evaluated patient in vehicle and then transported; contacted patient by phone at 7 pm on 3/31/2020 - was transported to Seton ER on 38th Street and received an antihistamine and medication for nausea, discharged at 5:00 pm and given new prescription for Epi pen since the one she had was expired; pt stated she felt much better",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,"Nexplanon, diphenhydramine and acetaminophen on 12/30/2020 at night for headache",,Hashimoto's disease,,"Shellfish in 2011, anaphylactic reaction, bee sting allergic reaction as a child; carries Epi pen","['Dizziness', 'Dry mouth', 'Dysphagia', 'Nausea', 'Throat tightness']",1,MODERNA,IM 917275,FL,72.0,M,"Developed rather sudden onset of neck stiffness and pain and then subsequent occipital and then frontal headache. Over next 6 hours became exceedingly painful as to prevent sleep or finding a comfortable position to rest my head. Went to Hospital ER at 2am on 12/31/2020. Had normal CT brain scan and labs. Given IV reglan, then ativan(1 mg) then 25mg benadryl and a liter of fluids. BP was slightly elevated 150/90 (?). Had oral temp of 99.1. When ativan didnt help they gave me a dose of dilaudid and zophran and additional dose of ativan. Then sent me home with instructions to take valium 5mg tid, orphenadrine 100mg Bid, Tylenol 650mg to 1300 mg q8hr prn and lidocaine patch on neck 5%(also started in ER) q 24hrs. Discharge diagnosis was headache, intractable neck pain and torticollis.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,PVT,"Tresiba 19 units daily, Victoza 1.8 mg daily, Metformin 850mg Bid, Losartin 25mg Bid, atorvastatin 20mg daily,",None,"Diabetes Type II, Hypertension(mild), chronic kidney disease stage 3(unknown cause) S/P Whipple Procedure 04/1998 for IPMN of pancreas",,Localized rash with Trulicity,"['Blood creatinine increased', 'Blood pressure increased', 'Body temperature increased', 'Computerised tomogram head normal', 'Full blood count normal', 'Headache', 'Laboratory test normal', 'Musculoskeletal stiffness', 'Neck pain', 'Red blood cell sedimentation rate normal', 'Torticollis']",1,MODERNA,IM 917276,IL,39.0,F,"Fever of 101, headache, sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"calcium, buproprion, fluoxetine",none,none,,none,"['Headache', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 917277,NJ,38.0,F,"24 hours after injection, sore arm that lasted a day. day 4- lymph nodes around armpit of injection arm sore day 6 - bump on injection site still experiencing soreness on the left arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/27/2020,1.0,PHM,nuvaring,none,none,,none,"['Injection site swelling', 'Lymph node pain', 'Pain in extremity']",1,MODERNA,IM 917278,,73.0,M,"sore arm for 2 days, no big deal",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PUB,,,,,,['Pain in extremity'],UNK,MODERNA, 917279,,37.0,F,Overwhelming fatigue/weakness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/30/2020,8.0,PVT,"Dexilant, vitamin d, bentyl prn",None,"History of covid infection 08/2020, Barrett?s esophagus, Gerd",,None,"['Asthenia', 'Fatigue']",1,PFIZER\BIONTECH,IM 917280,IL,54.0,M,"Vaccine received at ~830 on 12/30/20. At 1220am on 12/31, woke up shivering and freezing. Temperature was 103.1. Took a couple of Tylenol and retook my temp 40 mins later and it went up to 104.3. Then took some Advil and was able to get it back down to 103.1. was like that until about 530am and it started coming down 102, 101 and by 630 was 98.7. Had COVID in August. Feel perfectly fine by 0930 on 12/31.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Body temperature increased', 'Chills', 'Feeling cold']",1,MODERNA,IM 917281,TX,36.0,F,Fatigue that night and the following 36hrs,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,"Metoprolol 100mg daily, nifedipine 30mg daily, medroxyprogesterone 10mg q8h, prenatal vitamin 1 daily, vitamin d 5000 IU daily, vitamin c 1000mg daily",Menorrhagia,Hypertension,,Nkda,['Fatigue'],1,PFIZER\BIONTECH,SYR 917282,NJ,27.0,M,"Patient demonstrated adverse symptoms after covid vaccination manifested by: chills, headache, neck pain/stiffness, eye pressure.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,None,None,,None,"['Chills', 'Headache', 'Musculoskeletal stiffness', 'Neck pain', 'Ocular discomfort']",1,PFIZER\BIONTECH,IM 917283,WV,97.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,None,"gout, wears oxygen at home","gout, wears oxygen at home",,Walnuts,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917284,PA,28.0,F,"Diffuse rash on legs, buttocks, arms",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,01/01/2021,6.0,PVT,None,None,None,,None,['Rash'],1,PFIZER\BIONTECH,SYR 917285,TX,50.0,F,Light-Headed,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,,['Dizziness'],1,MODERNA,IM 917286,TX,60.0,F,headache within minutes of receiving the vaccine. Lasted 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,Zyrtec allergy,None,None,,None,['Headache'],1,MODERNA,IM 917287,WV,84.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Donepezil, Oxybutynin, Metoprolol, Divalproex Sodium",None,None,,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917288,OR,35.0,F,"Fatigue, headache, chills, sweats and nausea beginning the day after vaccination 12/29. Symptoms constant, but intermittently waxing and waning in intensity. Did limit normal activities. Reported check ins. Currently day 5 of a symptoms and was sent home from work today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,Multivitamin,None,"Eczema, reactive airway disease, raynauds",,Mild kiwi fruit allergy,"['Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Impaired work ability', 'Loss of personal independence in daily activities', 'Nausea', 'SARS-CoV-2 test negative']",1,MODERNA,IM 917289,WV,81.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"high blood pressure, baby aspirin, allergy pill",None,"HTN, seasonal allergies, diabetes mellitus",,maybe PCN,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917290,FL,31.0,F,Developed pruritis and erythema surrounding the site of injection lasting approximately 48 hours before completely resolving.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/29/2020,7.0,PVT,None,None,Anemia,,None,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 917291,NY,29.0,F,PATIENT COMPLAINED OF FUNNY FEELING AROUND THE NOSE AND INCREASED HEARTRATE SEEN APPROXIMATELY 20 MINUTES AFTER BEING VACCINATED. PATIENT THEN TOOK TWO BENADRYL 25MG TABS AND WITHIN 2 MINUTES HEARTRATE RETURNED TO NORMAL AND NO LONGER FELT FUNNY FEELING AROUND NOSE AREA.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PHM,,,,,NONE LISTED,"['Feeling abnormal', 'Heart rate increased']",1,PFIZER\BIONTECH,IM 917292,SC,52.0,F,"After receiving the vaccine, my eyes got severely dry to the point I had to use drops. They felt like sand was blown in them.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,"cellcept, aspirin , plaquenil ,losartan, and norvasc",none,lupus,,sulfa drugs,"['Dry eye', 'Eye irritation']",1,PFIZER\BIONTECH,IM 917293,WV,81.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Humalog, potassium, furosemide, isosorbide, eliquis, metoprolol, oxybutynin, synthroid, spironolactone",None,"Kidney disease, HTN,",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917294,IL,23.0,F,"Palpitations, nausea around 0745, chills and headache around 1330, fever of 101, extreme fatigue, flushing, and nausea 1930 and on",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Flushing', 'Headache', 'Nausea', 'Palpitations', 'Pyrexia']",1,MODERNA,IM 917295,AR,63.0,M,"Deltoid muscle pain at injection site began D1; involvement extended to all upper arm musculature and elbow on around D3 and to distal arm around D5. Presently (D10) muscle involvement and severity is unchanged. Muscle pain is dull ache whereas injection site pain is sharp. No swelling or redness is noted. No fever, chills or other signs of infection, just myalgia and questionable arthralgia of joints.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,PVT,Finasteride Pravastatin Tizanidine Omeprazole Famotidine Loratidine,None,None,,Nka,['Injection site pain'],1,MODERNA,IM 917296,TX,54.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,,,,,,['Headache'],1,MODERNA,IM 917297,IL,37.0,F,"soreness in left arm (site of injection) vertigo on 1/1/2021 at 5:30pm (dizziness that prevented standing, nausea, extreme fatigue). Pt has never experienced vertigo before. On 1/2/21 some mild dizziness remains though the pt can resume normal activity in the home.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,,none,,,,"['Dizziness', 'Dysstasia', 'Fatigue', 'Injection site pain', 'Nausea', 'Vertigo']",1,PFIZER\BIONTECH,SYR 917298,WV,87.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Amlodipine, hydrocholorathiazide, lisinopril, aspirin, metformin, sotalol, apixaban",None,None,,PCN,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917299,IL,38.0,F,IPSILATERAL TRAPEZIUS MUSCLE SPASM TREATED WITH IBUPROFEN AND HEAT STARTING ON 1/1/21 AND WORSENED ON 1/2/21,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,ZYRTEC FLONASE,NONE,NONE,,SEASONAL,['Muscle spasms'],1,MODERNA,IM 917300,NJ,42.0,F,"Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue swelling, mild fatigue, sinus pressure , shortness of breath 1 day later: redness injection site, moderate swelling or arm, mild head cold 2 days later: mild fatigue, sinus pressure, pain arm and redness of injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,MIL,"Symbicort, Allegra, Montelukast",Abscess in tooth was on amoxicillin for infection,Asthma,Flu shot mild dizziness,"Gluten sensitivities, Levequin, Keflex, Athmanex","['Dry mouth', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Headache', 'Immediate post-injection reaction', 'Injection site erythema', 'Nasopharyngitis', 'Pain in extremity', 'Paranasal sinus discomfort', 'Peripheral swelling', 'Swollen tongue']",,PFIZER\BIONTECH,SYR 917301,WV,77.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"blood pressure, cholesterol",None,"HTN, HLD",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917302,WV,81.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Parkinsons, blood pressure, cholesterol",None,"Parkinsons, HTN, HLD",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",UNK,MODERNA,IM 917304,CO,44.0,F,"I had a series of symptoms that culminated with a 103.9 fever at around 3:00 a.m., the morning after my first vaccination. Most symptoms were in the list of common side effects. What seemed different was how extreme my symptoms were extreme shivering and very high fever. The fever lasted several hours and seemed to go don rather quickly after shedding the layers I put on to manage the extreme shivering/chills, took two Advil, and used a cold compress on my head.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,Depression/anxiety,,,"['Chills', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 917305,WV,81.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Oxybutynin 10mg, Synthroid 75mcg, Rosuvastatin 40mg, Ezetimibe 10mg, Mirtazapine 30mg, Doxazosin 1mg, Metoprolol ER 100mg, Losartan 100mg, Amlodipine 10mg",None,"HTN, hypothyroidism, bladder problems, enlarged prostate, depression, HLD",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917307,TN,46.0,M,"Running 102.1 fever, Very sick Feeling Throwing up Very achy in the legs Very fatique Pain in Arm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,"Amlodopine Beyeselate, Amlodopine, Celexa, Prednisone, Ropinirole, Vitamin D3 IU2000",Tested positive for Covid10 on November 7th 2020,Lung Disease (Idiopathic Pulmonary Hemositerosis),,,"['Fatigue', 'Malaise', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,MODERNA,SYR 917308,WV,81.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,OTC Vitamins,None,None,,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917309,,36.0,F,"Patient felt nauseated and dizzy; HR went from 48 (Normal for patient) up to 58 and remained at 58 until discharge; BP=80/42 and went up to 92/58 (normal for patient); patient given juice, water and crackers and stated she felt better; discharged with co-worker; alerted to contact ED with any excerbation of symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,,,,,,"['Blood pressure increased', 'Dizziness', 'Heart rate increased', 'Nausea']",1,PFIZER\BIONTECH, 917311,WV,82.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Plavix, Aspirin",None,CVD,,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",UNK,MODERNA,IM 917313,WV,93.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"blood pressure, synthroid, trazodone",None,"HTN, hypothyroidism",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917315,PA,52.0,F,"headache, chills, fatigue, nausea starting 1-2 hours after vaccine dose and lasting 7 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,WRK,"synthroid, claritin",none,post-surgical hypothyroidism,,flagyl,"['Chills', 'Fatigue', 'Headache', 'Nausea']",UNK,PFIZER\BIONTECH, 917316,WV,79.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Plavix, Metoprolol, Amlodipine, Cilostrazol",None,HTN,,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917317,PA,37.0,F,"About 24 hours later I started having chills, then body and head aches with a swollen lymp node, low grade fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PUB,None,"None at the tome of the vaccine. After the vaccine I had a low grade fever, chills, head and body aches.",None,,Allergic to penicillin,"['Chills', 'Headache', 'Lymphadenopathy', 'Pain', 'Pyrexia']",1,MODERNA,SYR 917318,WV,92.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Warfarin, anxiety",None,"Pacemaker, anxiety",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917319,WV,85.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by WV National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from WV National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,Norvasc,None,HTN,,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917320,WV,85.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by WV National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from WV National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Pantoprazole 40mg, Citalopram 10mg, Atorvastatin 80mg, Carvedilol 3.125mg, Magnesium 400mg, Vitamin D2 1.25mg, Levothroxine 75mcg, Prednisolone AC 1% eye drops, OTC Multivitamin, OTC Preservision, Zyrtec, Aspirin 81mg, Dimenhydrinate 50mg",None,"CVD, fluid on lungs, eye problems",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917321,MA,35.0,F,"slightly hardening of the skin with slight irritation, no treatment needed so far",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,01/02/2021,11.0,OTH,"prenatal multivitamin, 81mg ASA",none,none,,sulfa,"['Skin induration', 'Skin irritation']",1,MODERNA,IM 917322,OK,40.0,F,"Severe headache same day lasting for 36 hrs. Severe fatigue starting next day lasting 24 hrs. Severe headache starting again on day 4 lasting through day 5. Unable to focus, eat because of headache. Sore arm for 24 hrs post vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,Spirinolactone Bupropion,No,No,,Vancomycin Levaquin Penicillin,"['Decreased appetite', 'Disturbance in attention', 'Fatigue', 'Headache', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 917323,,56.0,M,"abdominal pain starting two days after injection, testicular pain",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/30/2020,2.0,UNK,"Allopurinol, flonase, levothyroxine, loratadine, losartan, sildenafil PRN, tamsulosin",,"HTN, obesity, gout, ED, hypothyroidism, prostate Ca",,"lisinopril, morphine","['Abdominal pain', 'Testicular pain']",1,PFIZER\BIONTECH,SYR 917324,WV,85.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by WV National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from WV National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Levothyroxine 75mcg daily, Warfarin Sodium 2mg daily, Simvastatin 10mg daily, Amlodipine 5mg daily",None,"hypothyroidism, HTN, HLD",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917325,CO,64.0,F,"Hours after the vaccine developed cough, tiredness, neck aches, chills, headache, orbital pain, nausea. By that evening had fever 100.6 in addition to other symptoms. Next morning same symptoms. That afternoon, extreme tiredness along with prior symptoms. That evening fever 102.8. Next morning, exteremely dizzy, head foggy, orbital pain, minor cough. By Thursday no better so got covid test.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,OTH,"atorvastatin, citalopram, Vitamin C, B and zinc",none,high cholesterol,,none,"['COVID-19', 'Chills', 'Cough', 'Dizziness', 'Eye pain', 'Fatigue', 'Feeling abnormal', 'Headache', 'Nausea', 'Neck pain', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,MODERNA,IM 917327,WV,83.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Allergy, aspirin, cholesterol",None,"Allergies, HLD",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917328,OH,21.0,F,"1 week after receiving the vaccination, a red welt appeared on my arm where the injection was given. It was hot, raised and itchy and about an inch and a half wide and long. I drew a line around it. The next day it was less itchy and hot but had gone about half an inch outside the initial lines. The third/ fourth day it was barely raised at all but had gotten even larger, now about 1.5-2inches outside the initial lines in some areas. It is now barely raised, barely red and has not gotten any larger since yesterday.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/30/2020,7.0,WRK,"Arnuity (asthma), Tilia FE (birth control),",,Asthma,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Injection site warmth', 'Urticaria']",1,MODERNA,IM 917329,TX,76.0,F,"Headache , Lightheaded",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Dizziness', 'Headache']",1,MODERNA,IM 917330,WV,81.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,,None,"HTN, DMII",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917331,NC,38.0,F,delayed intermittent ache in L upper arm/shoulder/neck area.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/30/2020,10.0,PVT,"b-complex, vitamin D, adderall, ginko, st. john's wart, colace, iron sulfate, flax seed oil, turmeric, CBD oil (THC-free)",,history of rheumatoid arthritis,,azithromycin,"['Injection site pain', 'Neck pain']",1,PFIZER\BIONTECH,IM 917332,CA,33.0,F,"Within 2 hours of receiving the vaccine, patient had itchy throat, swollen lip which was confirmed on exam by ED physician and she received benadryl which resolve the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,none,none,none,,"allergies to sulfa, walnut, allergic rhinitis","['Lip swelling', 'Throat irritation']",1,PFIZER\BIONTECH, 917333,WV,87.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Aspirin, Norvasc, Lisinopril, Hydrocholorthiazide, Iron, Protonix, Metoprolol,",None,HTN,,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917335,WV,83.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Atenolol, Simvastatin, Tamsulosin, Losartan, Aspirin, Finasteride",None,HTN,,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917336,IL,42.0,F,"Initial: Cold sensation and tingling in left arm and hand Next 3-5 days mild tingling in Left arm, Left hand/wrist, Left fingertips and some on left side of face",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,WRK,Probiotic,,,,,"['Feeling cold', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 917337,WV,80.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Blood pressure, Vitamin D, Zoloft",None,"HTN, depression",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917338,NJ,41.0,M,"5 minutes post vaccine administration I started to feel palpitations, numbness on both arms and went up the nape/head, flushing, tingling in both arms dizziness, then dysphagia but able to talk. Hives at torso after 10 minutes. I was assessed by to physicians working at the site. Epi pen was given to me by a physician and taken by ambulance to hospital by EMTs who were there at the site. At the hospital I was given 40mg steroids by mouth. After observation for 4 hours I was feeling better, and was discharged home. Ordered to take 40mg of steroids for 2 more days. After one day post vaccination, I have significant pain at the site and body ache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,"Benadryl 50mg PO, Claritin 10mg PO, Pepcid 20mg PO one hour prior vaccination",,,,IV contrast (Visipaque 320) Anaphylaxis,"['Dizziness', 'Dysphagia', 'Flushing', 'Hypoaesthesia', 'Injection site pain', 'Pain', 'Palpitations', 'Paraesthesia', 'Urticaria']",1,MODERNA,IM 917339,TN,37.0,F,Pt. states woke up on 12/31/20 at around 8:00 and had blurry vision. States can see some things far away but can't see close up... Denies having any blurry vision prior to vaccination. States blurriness has neither improved or worsened. Denies any other symptoms or problems. Referred to Emergency Department for care regarding blurry vision. Encouraged pt. to call and notify health department of emergency departments assessment.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PUB,"Aleve PO daily, Vit. D PO daily, Vit. E PO daily, Hormone patch",None,None,,None,"['Hypermetropia', 'Vision blurred']",1,MODERNA,IM 917340,CA,33.0,F,"within 2 hours of the vaccine, patient had angioedema of lip and itchiness in throat which was verified by physlcal exam by the ED physician. She was given benadryl and symptoms improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,none,none,none,,"sulfa drug allergy, walnut food allergy, also has allergic rhinitis to environmental allergens","['Angioedema', 'Throat irritation']",1,PFIZER\BIONTECH,IM 917341,TX,68.0,F,"Hot across the chest area, given benadrily 50mg orally and discharged @ 12:32pm with symptoms relieved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,,['Chest discomfort'],1,MODERNA,IM 917342,TX,75.0,M,after i sneezed friday morning i lost all sight in my right eye. the emergency room did not know what was wrong and i see a eye specialist on monday.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,MIL,"several blood pressure, chroestrol, prostate, stomach.",none,"hbp, neurophy, bad back.",,nacain,['Blindness unilateral'],1,MODERNA,SYR 917343,WV,82.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Allopurinol, Furosemide, Simvastatin, Amlodipine, Cacecitanine, Metformin, Lisinopril, Celebrex",None,"colon CA, HLD, HTN",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917344,IL,64.0,M,"Chills, fever, headache, started about 9hrs after injection Fever peaked @ 100.8? injection site very sore. And continues to be sore. Fever broke the following day. Weakness, fatigue, headache persisted until afternoon of 1/1 2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,1000mg vitamin C Losartan/ HTC 100-25 Nifedapine 60mg,None,None,,None,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pyrexia']",1,MODERNA,SYR 917345,WV,81.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,High Blood Pressure,None,HTN,,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917346,WI,26.0,F,7-10 days injeciton site tender painful and redness not resolving size about the size of iphone xr picture available,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/30/2020,6.0,PVT,none,none,none,,none,"['Injection site erythema', 'Injection site pain', 'Laboratory test']",4,MODERNA,IM 917347,CA,44.0,F,"Within 2 hours of the vaccine, patient had shortness of breath, urticaria, nasal congestion and EKG and CXR were normal in ED and she was given albuterol, decadron, famotodine, and epinephrine and resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,PVT,none,none,none,,"asthma, food allergies, and environmental allergies","['Chest X-ray normal', 'Dyspnoea', 'Electrocardiogram normal', 'Nasal congestion', 'Urticaria']",1,PFIZER\BIONTECH,IM 917348,WV,90.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by the agency. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and regulatory authority website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from the agency that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,"Metorpolol, Lasix, Insulin",None,"CHF, Diabetes, HTN, arthritis",,Lisinopril,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917349,WV,88.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by the agency. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and regulatory authority website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from the agency that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,Hydrocholorothiazide,None,HTN,,Eggs,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917350,WY,20.0,F,"27Dec2020 - patient developed some swelling (went about 1 inch out from injection site) and discomfort at the injection site - had taken Advil and was using a cool compress. 29Dec2020 - patient had to leave work early since she was not feeling well - very fatigued and a little dizzy (able to eat/drink) - denied any COVID illness s/s (no cough, fever, loss of taste/smell, etc). She ended up going to the local ED - since she was still very fatigued and was feeling like she was going to pass out - blood work and U/S done - this is where she found out she had been pregnant but had lost the pregnancy (no heart beat). Per her report - all other blood work was unremarkable. No other medications given to her during this visit and was just told that she would be 'passing the products of conception within this next week'.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/27/2020,1.0,PVT,None,None,None,,None,"['Abortion spontaneous', 'Blood test', 'Dizziness', 'Exposure during pregnancy', 'Fatigue', 'Foetal heart rate abnormal', 'Impaired work ability', 'Injection site discomfort', 'Injection site swelling', 'Malaise', 'Pregnancy test positive', 'Ultrasound scan']",1,MODERNA,IM 917351,,39.0,F,"shortness of breath, difficulty breathing, chest tightness. She administered epinephrine and recovered quickly",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Chest discomfort', 'Dyspnoea']",UNK,PFIZER\BIONTECH, 917352,WV,92.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by WV National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from WV National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,,None,HTN,,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917353,NE,52.0,F,"Swelling at the site, Day one was about size of a 50 cent piece Day two- size of a baseball and was very itchy Day Three- size of a Softball and is very itchy and more than fills the palm of your hand",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,"Lisinopril, synthroid, cymbalta, vitamin D, dycyclomine, gabapentine, amatryptoline,",I had Covid on ThanksgivingFibromyalgia,"Fibromyalgia, blood pressure, Thyroid, extremely low Vit D,",,"anything that grows on tree fruits and nuts, shellfish,","['Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 917354,WV,90.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"""Diabetic meds, thyroid meds, BP meds, Blood thinner""",None,"Pacemaker, diabetes, hypothryoidism, HTN",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917356,WV,95.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"""Blood thinner, heart pill""",None,,,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,SC 917358,OH,21.0,F,"Started with arm pain, then lymph nodes in armpit were swollen and arm pain increased, could barely move arm because of pain, nausea and vomiting, chills and fever of 100.9, injection site the size of a baseball almost 48 hours after injection, super fatigued",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,PVT,"Sertraline, lofarin-FE",None,None,,None,"['Chills', 'Fatigue', 'Injection site swelling', 'Lymphadenopathy', 'Mobility decreased', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 917359,WV,81.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"aspirin, namenda XR, sertaline, metoprolol, Crestor, lisinopril, Plavix",None,HTN,,"Paint, Shingles vaccine, PCN, morphine","['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917360,CA,39.0,F,"Within 45 min, patient had nausea, dizziness, and was given ondansetron and fluids with improvement",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,none,none,none,,"penicillin, ampicillin, pineapple food allergies","['Dizziness', 'Nausea']",1,PFIZER\BIONTECH,IM 917361,WV,84.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Xarelto 20mg daily, Myrbetriq 50mg daily, diltiazem 120mg BID, Citalopram 10mg daily, Simvastatin 20mg daily",None,HLD,,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917362,TX,65.0,F,"Low grade fever 24 hours after immunization, also direct exposure to person with covid 19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Exposure to SARS-CoV-2', 'Pyrexia']",1,MODERNA,IM 917363,MT,25.0,F,Tenderness Swelling Redness All lasting 3 days after injection,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,MIL,Mini birth control pill Motrin,Mastitis starting Saturday prior,,,,"['Erythema', 'Swelling', 'Tenderness']",1,MODERNA,SYR 917364,PA,37.0,F,"Redness, warmth, itching, swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/28/2020,5.0,PVT,Metformin Azithromycin Spironolactone,,,,NKDA,"['Erythema', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,IM 917365,WI,44.0,F,"At injection site, at 1202, redness, rash, itchiness, and warmth. Then at 1206 head itchiness. Cold Compress applied to injection site. Later patient reported whole body itchiness and rash that was not raised. Patient is an NP and took prednisone.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,WRK,unknown,unknown,unknown,,unknown,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 917366,CT,36.0,M,"I performed a mild workout 30 minutes prior to the start of symptoms. I started to feel moderate body aches in my back and sides, felt flush and very tired and heavy. Temperature rose to 99.3. Symptoms began to subside after about 4 hours and temperature came down to a normal 98.3.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,UNK,,,Acid Reflux,,,"['Back pain', 'Body temperature increased', 'Discomfort', 'Fatigue', 'Flushing', 'Pain']",1,MODERNA,SYR 917367,VT,47.0,F,Erythematous plaques/rash starting one day after vaccine that worsened at day 7 to eyelid swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,,,"mild intermittent asthma, eczema, seasonal allergies",,"shellfish- anaphylaxis, sudafed, pineapple-anaphylaxis","['Rash erythematous', 'Skin plaque', 'Swelling of eyelid']",1,MODERNA,IM 917368,WV,82.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,"Norvasc, Toprol, Lopid, Advil, Synthroid, cholesterol",None,"HTN, HLD, hypothyroidism",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917369,WV,98.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by the agency. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and regulatory authority website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from the agency that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Aspirin, ""blood pressure pill""",None,"CVD, HTN",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917371,NH,28.0,F,Appeared to have a vasovagal reaction with nausea and dizziness lasting approximately 5 minutes. Did not pass out. Symptoms self resolved and patient refused EMS services.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,OTH,none,,none,,none,"['Dizziness', 'Nausea', 'Presyncope']",1,MODERNA,IM 917373,WV,91.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"""blood pressure pill"", Metformin, Xanax, Hydrocodone",None,None,,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917374,WV,80.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Synthroid, Amiodarone, Eliquis, Losartan",None,"CVD, HTN",,PCN,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917375,CA,60.0,F,"Within 5 minutes of the vaccine, patient had wheezing, shortness of breath and chest pain. patient given epi x 4, decadron, fluids with some improvement and then hospitalized. IN the hospital, patient continued to have chest pain and satting well but with protracted course and is still in the hospital.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,none,none,none,,environmental allergies,"['Chest X-ray', 'Chest pain', 'Dyspnoea', 'Echocardiogram', 'Wheezing']",1,PFIZER\BIONTECH,IM 917376,WV,81.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Synthroid, Omeprazole",None,"Heart Surgery in past, hypothyroidism",,Codeine,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917377,CA,20.0,F,"redness, heat, and swelling at the injection site. three and a half inches by 5 inches and expanding. went to the urgent care and the provider prescribed antibiotics, taking the antibiotics if the symptoms worsen in the next 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/01/2021,8.0,UNK,,,,,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 917378,FL,19.0,F,The patient sat down for 15 minutes to be observed for any reactions and told us that she had numbness on the right side of her face and right arm as well. She then told us that the numbness was spreading to her neck and right leg as well. EMS was called and took her to the hospital.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,SEN,,,,,Bactrim,['Hypoaesthesia'],1,PFIZER\BIONTECH,IM 917379,GA,36.0,F,"I HAVE SEVER ASTHMA AND BRONCHITIS AND GET PNEUMONIA 2 OR 3 TIMES A YEAR. I HAVE TROUBLE TAKING A DEEP BREATH AND CONSTANTLY TAKING MY INHALERS DAILY TO BREATH, I ALSO TAKE STEROIDS. I TOOK THE VACCINE AFTER GETTING OFF WORK ON 12/31/2020. THE NEXT DAY ON 1/1/2021 AND WOKE UP BEING ABLE TO TAKE A DEEP BREATH WITH NO PROBLEMS AND NO CHEST PAINS OR COUGHING. IT IS 1/2/2021 AND I HAVEN'T TOOK NONE OF MY INHALERS OR STEROIDS SINCE I TOOK THE VACCINE. IT IS AN AMAZING FEELING TO BREATH WITHOUT PAIN OR TAKING ANYTHING.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PUB,1 - INHALER TWICE A DAY (MORNING AND NIGHT) 2 - INHALER AS NEEDED THROUGHOUT THE DAY,SEVEDR ASTHMA AND BRONCHITIS,SEVEDR ASTHMA AND BRONCHITIS,,NONE,['Therapeutic response unexpected'],1,MODERNA, 917380,NY,63.0,F,"Temperature of 101, severe body aches and severe headache. Lethargic and in bed all day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,none,no,no,,none,"['Body temperature increased', 'Headache', 'Lethargy', 'Pain']",1,MODERNA,IM 917381,WV,81.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"""blood pressure pill""",None,HTN,,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917382,IN,25.0,M,"Approximately 12 hours after injection, I experienced hot flashes, chills, and a severe headache. The next morning I experienced a less severe headache but experienced noticeable shortness of breath especially on exertion. Tylenol P.O. helped my headache that morning, no known fever. Approx 2 days after injection I also experienced a noticeable reduction in the ability to smell or taste. This Stayed for at least another day or so.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,None,None,None,,None,"['Ageusia', 'Anosmia', 'Chills', 'Dyspnoea exertional', 'Headache', 'Hot flush']",1,MODERNA,IM 917383,WV,87.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"""Blood pressure pill, cholesterol pill""",None,"COPD, HLD, HTN",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917384,CA,36.0,F,"Tingly face, lips, and tongue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,UNK,Na,Na,Na,,Na,"['Paraesthesia', 'Paraesthesia oral']",1,MODERNA,IM 917385,WV,80.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Finasteride 5mg daily, Isosorbide Mononitrate 30mg daily, Lisinopril 10mg daily, Metoprolol Succinate 25mg daily, Plavix 75mg daily, Rosuvastatin 20mg daily, Ramsulosin 0.4mg daily, Folic acid 1mg daily",None,"HTN,",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917387,IL,24.0,F,"Stiffness and pain in neck and right upper back for 3 days unresolved by OTC NSAIDs (Aleve & Ibuprofen). Pain around right scapular area. Pain radiating to right upper arm on third day. Unable to move neck and back, sleep, carry on with normal activities. Pain is a burning and pulsating sensation that keeps me up at night. Unable to take a deep breath.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,Iron 65mg,Iron deficiency anemia,None,,NKA,"['Arthralgia', 'Back pain', 'Insomnia', 'Joint range of motion decreased', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Musculoskeletal stiffness', 'Neck pain', 'Pain', 'Pain in extremity', 'Painful respiration']",1,MODERNA,IM 917388,OH,62.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,SEN,,N/a,N/a,,N/a,['Headache'],1,PFIZER\BIONTECH,IM 917389,WV,83.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by the agency. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and regulatory authority website for the Moderna vaccine. Instead, the medication in the vial was actually COVID-19 antibodies meant for hospital use. After administration for 44 individuals, we received call from the agency that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Amlodipine, Cymbalta, Metorpolol, Atorvastatin, Claritin",None,"past MI, blood pressure",,"PCN, Sulfur","['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917390,NJ,56.0,F,A rash on the right check,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,PHM,none,none,none,,none,['Rash'],1,MODERNA,IM 917391,WV,81.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Metformin, ""blood pressure pill"", ""sugar pill""",None,"HTN, Diabetes Mellitus",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917392,,38.0,F,"In addition to a scratchy throat and body aches, I experienced mild mental fogginess. It's the same mental fogginess I experience when I have a head cold.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/02/2021,3.0,MIL,Trazadone 50 mg Adderall 10 mg Effexor XR 150 mg Cyclafem 1/35 EQ 1 mg Crestor 40 mg Nitrofurantoin 50 mg Aleve 440 mg,Anxiety Depression Insomnia Hyperlipidemia Sickle Cell Trait Persistent UTIs Chronic Back Pain,Anxiety Depression Insomnia Hyperlipidemia Sickle Cell Trait Persistent UTIs Chronic Back Pain,,"No known Drug Allergies, but advised not to take Decadron (oral steroid) No other Allergies","['Feeling abnormal', 'Pain', 'Throat irritation']",1,MODERNA,SYR 917393,FL,66.0,F,"Elevated blood pressure and heart rate. 163/116 HR 125. I got up at 9:00 am with elevated BP and HR. I had missed a dose of Metoprolol the previous evening. I felt shaky/jittery and checked my BP and HR. Called the doctor on call at my PCP's office and he stated it is probably rebound hypertension and elevated HR due to missing the dose of Metoprolol last night. His direction was to check in two hours, and if still elevated, take 1/2 tablet Metoprolol. Current readings at 2:00 pm are 129/97 HR 99. Unsure if related to Covid vaccine. MD recommended reporting to CDC",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/02/2021,2.0,OTH,"Losartan/HCTZ, Metoprolol, Amlodipine, Anastrozole, Venlafaxine, pepcid, Vitamin D, B12",none,hypertension,,none,"['Blood pressure increased', 'Feeling jittery', 'Heart rate increased', 'Tremor', 'Withdrawal hypertension']",1,MODERNA,SYR 917394,TN,54.0,M,Chest tightness and squeezing sensation; SOB; chills; low grade fever; quivering of legs;,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"metoprolol, lisinopril, paxil, zocor",none,"anxiety, hypertension, high cholesterol",,stadol,"['Blood test normal', 'Chest discomfort', 'Chills', 'Dyspnoea', 'Electrocardiogram normal', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tremor']",1,MODERNA,IM 917395,WV,80.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Aspirin 325 daily, Cardizem 360mg daily, Lopressor 100mg BID, Midodrin 5mg BID, Vasipa 1000mg QID, Myrbetriq 50mg daily, Zetia 10mg daily, Torsemide 40mg daily, Digoxin 125mcg daily, Singulair 10mg daily, Trazodone 100mg daily, Fenobrita 16",None,CVD,,None,['Product monitoring error'],1,MODERNA,IM 917396,WV,87.0,F,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,PUB,"""blood pressure medication, acid reflux medication""",None,"HTN, acid reflux",,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917397,LA,38.0,F,woke up and all of a sudden felt like I had pulled several muscles the left side of my neck and shoulder. But I hadn't done anything. Pain progressed as did stiffness within an hour to the point that I can barely move my neck without significant pain to neck and down into shoulder. It has been like this for almost 5 hours now and has not improved. Prior to this - the day and night i got vaccinated I felt fine. the following day I had a pretty bad headache. And then this morning this new thing happened. I am not worried about the headache as that is normal. I am worried about this severe pain and stiffness that is localized in one part of my body and is not going away.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,WRK,no,none,"asthma, PCOS",,"cats, pineapples","['Headache', 'Mobility decreased', 'Musculoskeletal stiffness', 'Myalgia']",1,MODERNA,SYR 917398,WV,81.0,M,"No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by the agency. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and regulatory authority website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from the agency that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,None,None,None,,None,"['No adverse event', 'Product label confusion', 'Wrong product administered']",1,MODERNA,IM 917399,FL,65.0,M,"Dizziness, nausea, fever, headache, abdominal pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,"Prescription Flomax, finestride Supplement Alpha lipoic acid, noni",,Diabetes,,"Peanuts, shellfish","['Abdominal pain', 'Dizziness', 'Headache', 'Nausea', 'Pyrexia']",1,MODERNA,SYR 917400,KS,32.0,F,"Injection site red, swollen, warm to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/01/2021,1.0,PVT,,,,,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 917401,UT,36.0,F,"Tennis ball size hive that was itching and warm to the touch. This hive came and went 2-3 times over the course of 1 week, each time it got bigger and hotter and more itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/26/2020,8.0,PVT,,Congestion,Reactive airway,,"Nuva ring, cipro","['Pruritus', 'Skin warm', 'Urticaria']",1,PFIZER\BIONTECH,IM 917402,IA,60.0,F,"increase warmth, pain at injection site, aching of entire left arm, then aching of neck, shoulders, back, hips, legs, headache by 7pm same day of injection. By 10pm, shaking chills, severe aching all over body, bad headache. Had taken aleve and omeprazole by 7pm with supper as per usual routine. At 10pm I took tylenol 650mg and cyclobenzaprine 2.5mg and crawled into bed. Slept 2 hours, woke without shaking but head throbbing, nose congested more, body still very achey, and heart pounding. This went on rest of night and all next am. temp at 10am 1/2/21 100.8 orally. Had not taken it before that. Took 2 aleve, drank glass water & ate toast. Slept til around 2pm. temp then 100.4. less achey in back, legs but arm still very sore and headache, hips hurt and neck hurt. Slowly better overnight to 2/2/21 but still not over headache, arm pain, neck ache and hip pain. All are less, however.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"omeprazole, aleve, effexor, premarin, vit b complex, vit d3, atorvastatin, cyclobenzaprine, fluticasone, tylenol.","head cold with nasal congestion, postnasal drainage","mild depression, gerd, hyperlipidemia, menopausal symptoms, food and environmental allergies all for years.","shingrix--2nd dose, for shingles ?date 2019","sulfa meds, rash to ampicillin, eggs, potatoes, chocolate, milk products, molds, dust mites","['Arthralgia', 'Back pain', 'Body temperature increased', 'Chills', 'Feeling hot', 'Headache', 'Nasal congestion', 'Neck pain', 'Pain', 'Pain in extremity', 'Palpitations', 'Tremor']",1,MODERNA,IM 917403,WI,61.0,F,"Fever up to 104 x 2 days, chills, severe arm pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Chills', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA, 917404,IL,32.0,M,"Sx onset 1/1/2021 Chills, (no fever), aches, fatigue, Pain at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PUB,none,none,none,,none,"['Chills', 'Fatigue', 'Injection site pain', 'Pain', 'SARS-CoV-2 test']",2,MODERNA,IM 917405,PA,35.0,F,Facial itiching with hypersensitive skin started a 2-3 days after injection. Swelling of face and eyes and blotchy facial skin 13 days after injection. Seen by ED physician for steroids and benadryl. Slight decrease in swelling 24-36 hrs post start of steroid regimen.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/19/2020,12/31/2020,12.0,PVT,Iron 65mg BID,,,,Augmentin shellfish,"['Eye swelling', 'Pruritus', 'Rash macular', 'Sensitive skin', 'Swelling face']",UNK,PFIZER\BIONTECH,IM 917406,MT,46.0,F,Fatigue. Body aches. Nausea. Heart racing. Chills Nausea.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,Thyroid medicine Aspirin,None,Hypothyroidism Breast cancer cancer free 2 years ago,,Pyridium Seasonal allergies,"['Chills', 'Electrocardiogram normal', 'Fatigue', 'Full blood count normal', 'Nausea', 'Pain', 'Palpitations', 'Pregnancy test negative', 'Thyroxine normal', 'Troponin normal', 'Urine analysis normal']",1,MODERNA,IM 917407,FL,73.0,F,12/31/2020 very dizzy 1/1/2021 not as dizzy but still dizzy 1/2/2021 still dizzy,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,SCH,Tylenol PM 1/2 pill Vitamin E COQ10 Simvastatin 20mg Thyroxine 40mg Biotin Glucosamine Chondroitin Prilosec,,,,Penicillin,['Dizziness'],1,MODERNA, 917409,OH,38.0,F,"Pt reports having arm/shoulder pain after receiving Covid vaccine injection. States the injection ""felt high"" and was more painful than typical IM vaccines she has had. Pt concerned about SIRVA.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PUB,unknown,,,,unknown,"['Injection site pain', 'Pain in extremity']",1,MODERNA,IM 917410,PA,23.0,F,"I received the vaccine at 11:30am. About a half hour after receiving the vaccine, I felt dizziness and very slight chest tightness. I took benadryl, and was relieved of these symptoms. Then, around 9pm that night, I developed a fever. The highest temperature I recorded was 101.9. I took Ibuprofen around 11pm, and was afebrile by 3am. I have not had any fevers since, and I did have to call off work New Year's day. I have had an intermittent, mild headache since receiving the vaccine as well, but overall I feel fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,None,None,Asthma,,Allergies to tree nuts,"['Chest discomfort', 'Dizziness', 'Headache', 'Impaired work ability', 'Pyrexia']",1,MODERNA,IM 917411,TX,23.0,M,I spiked a fever and became symptomatic and then tested positive via a rapid viral test.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,01/02/2021,11.0,PVT,None,None,None,,None,"['COVID-19', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,IM 917412,CT,34.0,F,"Whole body muscle aches, starting about 12 hours after the first injection, worsening for about 3 hours, then improving after about 20-24 hours, ending by 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Bupropion, methylphenidate, oral contraceptives",None,None,,None,['Myalgia'],UNK,MODERNA,SYR 917413,,22.0,F,"Extreme fatigue, hard to get out of bed, high fever, chills, headache, and extreme arm soreness that radiated all the way underneath my armpit and towards the back of my scapula",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PHM,Lexapro,Slightly scratchy throat,None,,None,"['Arthralgia', 'Axillary pain', 'Chills', 'Fatigue', 'Headache', 'Mobility decreased', 'Pain', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA, 917414,FL,57.0,F,Experienced extreme dry mouth immediately after receiving the Moderna Covid vaccine. Symptom relieved by water provided by hospital team observing patients after vaccination. Further relief obtained by consuming cool grapes. Reaction completely resolved within 15-30 minutes. I did not feel that medical attention was needed.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Metoprolol 12.5mg daily (4 years) Diltiazem CD 120mg daily (4 years) Vitamin D 50 mcg daily Zinc 50 mg daily Vitamin B Complex (Super) Nature Made daily,,Hypertension: Controlled (2016) Paroxysmal supraventricular tachycardia: Controlled (2016) Atrial flutter: Controlled (2016) Sickle Cell Trait,,Sulfonamides (Rash to Septra DS),['Dry mouth'],1,MODERNA,IM 917415,MI,61.0,F,"Approximately 48 hours after receiving vaccine, I developed nausea and extreme diarrhea. This lasted 2.5 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/25/2020,12/27/2020,2.0,PVT,"Cymbalta, Bentyl, Lipitor, Gabapentin, Trazodone, Prilosec, VitC, Vit B1, Vit D3, citrucil",none,osteoarthritis,,"Amoxicillin, Benazepril, Hydroxychlorquine, Trymethopain, sulfamethoxazole","['Diarrhoea', 'Nausea', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,SYR 917416,AR,36.0,F,"Received the COVID19 vaccine 2 weeks ago, and the next day started to have dizziness/lightheadedness and palpitations. It was the worst the first 2-3 days after the vaccine. It has improved somewhat, but is still not fully resolved and my improvement seems to have pleatued in the past few days. It is not debilitating nor a deterrent for me getting my 2nd dose, but I felt compelled to report my symptoms as I don't see dizziness and palpitations listed as a possible side effect.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/20/2020,1.0,PVT,Daily prenatal vitamin,,,,NKA,"['Dizziness', 'Palpitations']",1,PFIZER\BIONTECH,IM 917417,WI,44.0,F,ocal allergic reaction warmness rash right at site of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,UNK,,,,,,"['Hypersensitivity', 'Injection site rash', 'Injection site warmth', 'Local reaction']",UNK,PFIZER\BIONTECH, 917418,IA,41.0,F,"perioral tingling, numbness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,UNK,doxycycline montelukast QUEtiapine hydroxyzine mupericin cetirizine prevident ventiafaxine azelastine butaibol-acetaminophen-caffeine; polyethylen glycol;pseudoephedrine; metrolnidzzole; troamphetamine; ropinirole; calcium carbonate; flutic,rhinitis; sinus infection,thoracic outlet syndrome; seratonin syndrome; adenomyosis; migraines; organic obstructive sleep apnea; major depressive disorder; OCD tendencies; anxiety; idioventricular conductive delay with epi;,,Sulfa PCN latex; sulfites; shellfissh; pollen; sensitivity to anesthesia; kiwi; avocado; epinephrine; banana; epi pen; lorazepan,"['Hypoaesthesia oral', 'Paraesthesia oral', 'Tryptase']",1,PFIZER\BIONTECH,IM 917419,WA,33.0,F,"At 15 minutes post vaccination, I became dizzy, short of breath and felt like I might lose consciousness. I was hypertensive, had cramping in my fingers and felt numbness in my toes. I laid flat on the floor for 30 minutes in observation and began to feel better by 11. The same thing happened 3 more times throughout the day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,PVT,"Flonase, Zyrtec, prenatal vitamins",None,None,,Mushrooms,"['Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Hypertension', 'Hypoaesthesia', 'Muscle spasms']",1,PFIZER\BIONTECH,IM 917420,IL,27.0,F,"Moderna Covid-19 Vaccine EUA Severe headache starting around 7:00 PM and ending around 2:00 AM the next morning, ibuprofen helped",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None,None,Asthma,,Allergic to cigarette smoke and scented things,['Headache'],1,MODERNA,IM 917421,,28.0,F,"31Dec 0300 Extreme body ache, unable to move left arm 31Dec Body aches, chills, swelling of injection site 31 Dec 1700 fever 102.1, injection site welt hard, painful, hot with 3 inch diameter, severe body aches and chills. Alternating Tylenol and Motrin begins fever lowers to 99 01Jan severe body aches and chills 01Jan 1130 fever of 101.1 while continuing alternating Tylenol and Motrin administration from previous day. 02Jan no fever, mild body aches, minor swelling and tenderness of injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,UNK,None,None,None,,None,"['Chills', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Mobility decreased', 'Pain', 'Pyrexia', 'Urticaria']",1,PFIZER\BIONTECH,SYR 917422,FL,60.0,F,5th day after receiving covid vaccine my lymph nodes in my right axilla were swollen and painful. It has been 2 days and remains swollen and painful.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/31/2020,5.0,PVT,"Atenolol. nexium, estrodial, levothyroxine, simvastatin, amitriptyline and magnesium/zinc/calcium",none,"IBS, palpitations",,"hydrocodone, cipro and levequin","['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 917423,FL,63.0,F,"Expiratory wheezeing, excessive phlegm in lungs, cleared up by morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,"Klor-Con M20, Medroxyprogesterone 5mg, Losartan !00mg, Chlorthalidone 25mg, Omeprazole 20mg, Estradiol 1mg, Bystolic 10mg, SuperB, D3 5000iu, Magnesium 400mg, Collagen w Biotin 6000mg",,High Blood Pressure,,,"['Productive cough', 'Wheezing']",1,MODERNA,IM 917424,MI,28.0,F,"Fever, muscle pain. Onset around 21 hours after vaccine, resolved around 6 hours later without intervention.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,None,None,None,,None,"['Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 917425,UT,31.0,F,"Nausea, stomach pain,",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,UNK,,,,,,"['Abdominal pain upper', 'Nausea']",1,MODERNA,IM 917426,OR,52.0,F,"Caregiver (cg) received Covid vaccine on 1/2/21 @ 0910. Cg was nervous but did ok with vaccine administration. Once in the observation area, cg became nauseous and raised her hand to report. Cg was sitting in one of the back rows so observation RN came to her. Observation RN was walking cg to lower level when she experienced syncope and fell forward down several steps and to the right hitting the front of her head and right shoulder on the wall. Cg was unconscious for approximately 30-45 seconds. Once alert, cg responded appropriately to questions, but slowly. Vitals were 120/82 P 107 at 0915 and 150/84 P 96 at 0920. Cg had 2 events of uncontrollable bilateral arm shaking lasting approximately 5-10 seconds. Rapid Response Code was called and cg taken to ED at 0940. C-collar and back board was used to transfer cg from floor to stretcher. Unknown at this time if caregiver was admitted.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,PVT,Unknown,Unknown,Diabetes,,Unknown,"['Fall', 'Head injury', 'Heart rate increased', 'Loss of consciousness', 'Nausea', 'Nervousness', 'Syncope', 'Tremor']",1,MODERNA,IM 917427,MA,36.0,F,Five minutes after receiving the vaccine the patient felt Dizziness and Hot,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,,,,,,"['Dizziness', 'Feeling hot']",1,MODERNA,IM 917428,NM,57.0,F,"On the evening of Sunday December 27th I became violently ill. I began vomiting and continued all night long. I had severe body aches and chills. I was unable to find my thermometer so am not sure of tempertature. I had lower back pain so severe I couldn't lie down. I tried to take Tylenol but was unable to keep it down. By morning I got access to Tylenol suppositories, Dramamine, and a thermometer. My temperature before Tylenol was 104.4. These symptoms continued over the next 3 days though vastly improved with Tylenol, Dramamine and IV fluids. I received a negative COVID test on Thursday. I have only been this ill once before in my life. By Thursday I was not longer febrile, only weak and exhausted. I have to now determine whether or not to get the second vaccination. I know this seems to be a somewhat delayed reaction. Any advice would be appreciated.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/27/2020,4.0,PVT,"Metoprolol, Vitamin D, Vitamin C",None,Hypertension,,NKA,"['Asthenia', 'Back pain', 'Chills', 'Fatigue', 'Illness', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting']",2,PFIZER\BIONTECH,IM 917429,ME,34.0,F,"shortly vaccine given patient felt anxious with sense of heart racing. exam revealed normal vital signs and examination of injection site normal. she had not eaten or had fluids in prior 5 hours, and she was placed in a reclining chair and given apple juice and crackers. she felt better within several minutes and exam remained normal. she was observed for and additional 30 minutes and remained symptom free.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,OTH,none,none,none,,none,"['Anxiety', 'Palpitations']",1,MODERNA,IM 917430,PA,24.0,F,"On 12/24/2020 started developing severe headaches with dizziness. On 12/27/2020 started getting chills, muscle aches, got covid tested (negative). On 12/29/2020 face and eyes started to swell, another covid test (negative). Continuous chills, sweats. Took tylenol, motrin, and benadryl around the clock. 01/02/2020 scratchy throat, more difficult to swallow, started on prednisone.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,Birth Control,None,None,,Amoxicillin,"['Chills', 'Dizziness', 'Dysphagia', 'Eye swelling', 'Headache', 'Hyperhidrosis', 'Myalgia', 'SARS-CoV-2 test negative', 'Swelling face', 'Throat irritation']",1,PFIZER\BIONTECH,SYR 917431,CA,35.0,F,Tingling at left side of face that moved down to lips at 15 minutes after injection. Tingling turned into numbing later on in day which included muscles on face moving slower when coming out of smile or frown. Lasted about 2 days. Also had severe muscle cramping in calves and arms.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Blisovi Fi (birth control),,,,,"['Facial paresis', 'Hypoaesthesia', 'Muscle spasms', 'Paraesthesia', 'Paraesthesia oral']",1,MODERNA,SYR 917432,MD,31.0,F,"Redness at injection site, painful to the touch, hot to the touch. Slight fever 99.4",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,WRK,Amlodipine 5mg,Hypertension,Hypertension,,,"['Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Pyrexia']",1,MODERNA,SYR 917433,OH,34.0,F,Fatigue started around 6pm and started to feel hot. As the night progressed I developed body aches and chills. Weakness. Just walking was difficult because I felt so wiped out. My arm was very painful with my hand tingling. Fever spiked at 102. Last until about 2 am and I fell asleep. Woke up with fatigue and feeling warm. No fever. Temp was 98.8. I had no appetite. Fatigue lasted the day. Woke up on Saturday and felt back to pre vaccine state,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,"Vitamin C 500 mg daily Magnesium 500 mg daily Vitamin d 50,000 units weekly",Covid-19 positive test was on 12/10. Symptoms started on 12/8 night. Still have an occasional non productive cough following covid. Smell and taste have not improved completely. Otherwise was feeling well when getting the shot.,None,,None,"['Asthenia', 'Chills', 'Decreased appetite', 'Fatigue', 'Feeling hot', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Pyrexia']",1,MODERNA,IM 917436,NC,27.0,M,"Severe headache, severe body-ache, nausea, weakness, fatigue, cold chills, hot waves, joint pain, fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,01/01/2021,31.0,PUB,,,,,,"['Arthralgia', 'Asthenia', 'Chills', 'Fatigue', 'Headache', 'Hot flush', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 917437,NY,68.0,F,"Slight itch at injection site ,developed increased redness and warmth,became 4x3 inch raised red welt with demarcation ,swelling of upper arm hard to the touch within 3-4 hours. Warm compress on day 2 Decreasing symptoms on day 3-diminished warmth and redness ,slowly resolving",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/30/2020,8.0,PVT,no new meds,none,none,,No known allergies,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Urticaria']",1,MODERNA,SYR 917438,UT,23.0,F,"Redness and pain of the arm., Shortness of breath, relieved with albuterol nebulizer at home. Sensation of swelling in the throat, but normal examination. Lungs were clear auscultation. Pulse oximetry was normal. Patient was prescribed an EpiPen, and instructed to go to the emergency room for any worsening of symptoms. Steroids were not prescribed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,PVT,,,Asthma,,,"['Auscultation', 'Dyspnoea', 'Erythema', 'Oxygen saturation', 'Pain in extremity', 'Swelling']",1,MODERNA,IM 917439,MN,19.0,F,"Small red rash appeared next to the injection site, my arm was sore. I felt achey, had a headache and a slightly upset stomach. I felt better within 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"Humalog, atorvastatin, sertraline",,Type one diabetes,"2020 Flu shot, same symptoms and resolve time, without the rash at injection site.",No known allergies.,"['Abdominal discomfort', 'Headache', 'Injection site rash', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 917440,TX,52.0,F,"RASH NOTED TO UPPER CHEST AREA AND UPPER BACK AREA-TOOK BENADRYL 25MG AT 1715 ON 12/31/20, RASH ALMOST ALL CLEARED UP BY 01/01/21, TOOK BENADRYL 25MG AGAIN AT 0900 ON 01/01/2, RASH ALL GONE BY 1700 01/01/21. NEVER HAD ITCHING OR PROBLEMS WITH SWALLOWING",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,PVT,PROBIOTIC VITAMIN C,NONE,NONE,,NONE,['Rash'],1,MODERNA,SC 917441,KS,43.0,M,"Nausea, vomiting, diarrhea, headaches, weakness, fatigue, chills, loss of appetite",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,PUB,,,,,,"['Asthenia', 'Chills', 'Decreased appetite', 'Diarrhoea', 'Fatigue', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA, 917442,MT,65.0,F,"Sore arm x 24 hours. Day 2 headache, nausea and body aches. Day 3 nausea and body aches. Day 4 extreme fatigue, nausea, diarrhea. Day 5 fatigue and nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,,none,none,,Codeine,"['Diarrhoea', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pain in extremity']",UNK,MODERNA,SYR 917443,IL,59.0,M,"Chills, Body Aches, and Headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,None,None,None,,Penicillin Codine,"['Chills', 'Headache', 'Pain']",1,MODERNA,SYR 917445,MA,34.0,F,Moderate sore arm by injection site about 12 hours after receiving shot and lasted only about 24 hours; fatigue and mild body aches around 24 hours after shot that lasted about 12 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,"Methimazole 5mg, labetalol 100mg, Zyrtec",Head cold,"Graves Disease, mild hypertension",,,"['Fatigue', 'Injection site pain', 'Pain']",1,MODERNA,SYR 917446,TX,28.0,F,"11 hours after injection I began to have chills and body ache, joint pain, muscle pain, slight headache, elevated temperature (max 100.0), dizziness, fatigue. All side effects subsided by 11/1 except fatigue. Fatigue subsided on 11/2.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,UNK,Heather 0.35mg,None,None,,None,"['Arthralgia', 'Body temperature increased', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Pain']",1,MODERNA,IM 917447,WI,54.0,F,Severe dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/31/2020,30.0,WRK,"Atenolol, Metformin, Trulicity, Vitamin C, Vitamin D, Zinc, HCTZ",None,"Diabetes Type 2, HTN",Tetanus,"Tetanus, Lisinopril",['Dizziness'],1,MODERNA,IM 917449,,27.0,F,several white hives at injection site 7 days after receiving first dose. the hives went away after several hours (I took 25 mg Benadryl right away). There was a big red spot on my arm around the injection site for about 24 hours after the hives went away.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,PVT,oral birth control,none,none,,sulfonamides-rash all over,"['Injection site erythema', 'Injection site urticaria']",1,MODERNA,IM 917450,,25.0,F,"Patient received Moderna COVID vaccine at 12:13. Patient noted that at 12:25 she felt lightheaded and nauseous. She denied any throat itching/swelling or difficulty breathing. At 12:40 vitals were: Blood Pressure: 118/84 Oxygen: 98 Pulse, 77. � After drinking water, patient noted she felt chills. After no improvement nor deterioration, patient was transferred to Convenient Care at 13:18.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,PVT,,,,,,"['Chills', 'Dizziness', 'Nausea']",1,MODERNA,IM 917451,WV,51.0,F,Headache 104� fever Severe vomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,PVT,Lexapro 10 mg,None,None,,Sulfa intolerance none,"['Headache', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 917452,CT,59.0,F,"Red and swollen deltoid , redness extending to arm after 2 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/31/2020,7.0,PVT,None,None,None,,Latex,"['Erythema', 'Injection site erythema', 'Injection site swelling']",UNK,MODERNA, 917453,NM,57.0,M,"FELT SLIGHTLY DISORIENTED RIGHT AFTER. IN AROUND FOUR HOURS POST-VACCINATION STARTED HAVING RIGHT SIDED HEADACHE, INCREASED SORENESS OF ARM, BODYACHE, JOINT PAINS. AFTER LEAVING THE WORK AROUND 11:45 PM, WENT HOME AND ATE AND WENT TO BED AROUND 1 AM, COULD NOT FALL ASLEEP TILL 2 AM, DID NOT WAKE UP TILL 13:30 NEXT DAY ON 12/31/2020, DID NOT HEAR ANY WAKE UP, ALARMS, FELT TIRED AND EXHAUSTED AND DRAINED. WENT THROUGH SEVERAL EPISODES OF DIZZINESS, DRAWSINESS WAKEFULNESS AND FEELING COMLETELY DRAINED AND EXHAUSTION FOR TWO DAYS. STILL HAVING MIND HEADACHE, BUT OTHER SYMPTOMS HAVE BEEN RESOLVED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"VALSARTAN/HCTZ COMBINATION, LEVOTHORAXINE, BIO-SHIELD",POST-TRAUMATIC MICROSCOPIC HYPHEMA OF RIGHT EYE & SEE #12,"HYPERTENSION, ALSO HAVE BLEEDING IN RIGHT VITREOUS HUMOR FROM THE SAME TRAUMA IN OCTOBER 2020",,DUST AND POLLEN,"['Arthralgia', 'Disorientation', 'Dizziness', 'Fatigue', 'Headache', 'Immediate post-injection reaction', 'Initial insomnia', 'Pain', 'Pain in extremity', 'Poor quality sleep', 'Somnolence']",1,MODERNA,IM 917454,TX,75.0,F,"Fever, chills, nausea beginning about 6 hours after the vaccination and continuing for about 36 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PHM,candesartan 32mg rousuvastatin 10mg D3 2000 units,None,None,,penecillin,"['Chills', 'Nausea', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 917455,WI,33.0,F,"Shortness of breath, elevated heart rate, elevated blood pressure, dizzy, diaphoresis. Still had episodes of tachycardia and diaphoresis at 8pm. Following day headache and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,WRK,None,None,None,,"Latex, kiwi","['Blood pressure increased', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Headache', 'Heart rate increased', 'Hyperhidrosis', 'Tachycardia']",1,PFIZER\BIONTECH,IM 917456,CO,32.0,F,Type 4 hypersensitivity,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PVT,None,None,None,,None,['Type IV hypersensitivity reaction'],1,MODERNA,SYR 917457,MA,42.0,F,"@ 1525 Pt stated to this nurse that her throat felt like it was ""burning a little"". Denies s/s of any breathing issues. Water was given to her by this nurse. @ 1528 she stated that it felt more like ""an itchy feeling in her throat/chest"". Expressed to this nurse around 1533 that the issues had slightly resolved, and that she felt anxious upon receiving the vaccine. This nurse gave Pt a Benadryl 25mg @ 1539. States that her s/s are better. Pt states she takes the following medications, Allegra po once daily, Flonase daily, and Flovent. Does voice that she has chronic allergies/asthma. Pt is still in observation @ present time 1552. Left observation @ 1554, states that her s/s had improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,WRK,"Allegra, Flonase, Flovent",,"Allergies, Asthma",,,"['Anxiety', 'Throat irritation']",1,PFIZER\BIONTECH,IM 917458,FL,39.0,F,Pt experience itching and redness of her skin. Pt was treated with Benadaryl 50mg and asked to wait to be observed an additional 30 minutes before leaving the facility. By the time pt left our facility her itching and redness had resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,WRK,Benadryl 50mg was given at the time of notification of the reaction,None report by patient,None reported by patient,,Shellfish per patient,"['Erythema', 'Pruritus']",1,MODERNA,IM 917459,TX,32.0,M,Less than 5 minutes after receiving vaccine the left side of my face went numb (same side as injection) as if I had a lidocaine injection. This lasted about 45 minutes to an hr and then self resolved. No slurred speech or facial drooping evident although I didn't look in a mirror. Later in evening I experienced pins/needles in left arm similar to reduced blood circulation.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,Omeprazole 20mg daily,None,None,,None,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 917460,CA,50.0,M,Med error. Full dose not administered. Syringe faulty. Administered full dose in addition to partial dose.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,PUB,,,,,,"['Intentional product use issue', 'Syringe issue', 'Underdose']",UNK,MODERNA,IM 917461,OH,33.0,F,"Large welt from injection site. Increasing pain in arm that received the vaccine. It began as just around the actual injection site. It has been 9 days and the pain has slowly increased and now aches from the injection site, my entire bicep muscle, and just below my elbow",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PHM,"Topamax, Effexor XR",,"Hydrocephalus, Chairi Malformation",,Vancomycin,"['Injection site pain', 'Injection site reaction', 'Pain in extremity', 'Urticaria']",1,PFIZER\BIONTECH, 917462,NJ,58.0,M,"12/31/20 7:30 pm mild fever 99.8. take Tylenol 01/01/2020 3;30pm fever 100.8, muscle aches , headache, fatigue. at 5;30 taken 2 Aleve, slept it off , walks up about 7:30am 1/2/21 still feeling a little fatigue, no fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,none,none,none,,none,"['Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 917463,PA,58.0,F,"I developed symptoms of the corona virus as I had in 3/2020 when I tested positive for COVID-19. I developed a headache, fever, aches, chills and extreme tiredness. The symptoms last about 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,"Citalopram, amlodopine, losartan-HCTZ",None,"HTN, Sleep apnea",,"Lisinopril,benadryl","['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 917464,TX,32.0,F,Woke up with a swollen lymph node in my left armpit on 12/22 (6 days after injection).,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/22/2020,6.0,WRK,"Seysara antibiotic (for ance), Junel birth control, One-A-Day Vitamin Gummies, D3 Vitamin Gummies, probiotic",no known,Chronic neck pain from herniated discs in C-spine,,no known allergies,['Lymphadenopathy'],1,PFIZER\BIONTECH,IM 917465,OH,41.0,M,Left arm where got shot from moderns vaccine caused my left arm and armpit lymph node to swell to the size just smaller than a tennis ball.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/01/2021,5.0,PVT,Atorvistatin,None,None,,None,"['Injection site swelling', 'Lymphadenopathy']",1,MODERNA,IM 917466,MT,30.0,F,"On day7 of administration, Patient reported itchy arm at injection site. On exam dime sized area of induration with warmth and redness surrounding it. No other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PUB,,no,,,nkda,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 917467,SC,50.0,M,"Had chills, body aches, and low grade fever starting approximately 14 hours after vaccination. Symptoms continued off/on for approx. 16 hours. Treated with Tylenol and Ibuprofen without any further issues. Arm was quite sore also for a day and a half.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,none,Had Covid 19 on 12/12/20,none,,none,"['Chills', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917468,NJ,57.0,F,"Very sore arm, weakness and dizziness after an hour. Next day, feverish, body aches, overall tired. Arm bruised and more sore than regular I'M injection. Feeling ""off"".",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,SEN,"Tagamet, zofran prn, trazadone, clonopin, multivitamin, protonix","Sore throat, nauseous - R/T gastric bypass surgery 10 yrs.ago",Chronic GERD,QuadrilENT flu vaccine,Dairy,"['Asthenia', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Injection site bruising', 'Injection site pain', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917469,CA,45.0,F,"Started with right arm tingling/slight numbness feeling down to my fingertips. Two days my left arm felt the same with slight improvement in my right arm. Later that day, I felt tingling in my left leg down to my toes. I have felt these symptoms every day since, but they have improved in severity, moving from one side to the other at times. This has not affected my activities of daily living, nor my work as a RN.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/24/2020,3.0,PVT,None,None,None,,None,['Paraesthesia'],1,PFIZER\BIONTECH,IM 917470,NY,50.0,F,"Went to see an urgent care MD that day, he confirmed it was a swollen lymph node. Followed up at my primary care office next week Dec 28th, MD confirmed it was swollen lymph node likely related to immune response to COVID vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,PVT,Ibuprofen prn,,,,Amoxicillin,"['Blood glucose', 'Blood pressure measurement', 'Chest discomfort', 'Chills', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Heart rate', 'Oxygen saturation']",1,PFIZER\BIONTECH,SYR 917471,NC,64.0,F,"Wednesday 12/30/20; ~ 4:30pm upon receiving vaccination, an immediate headache Thursday12/31/20 ~12 hrs later 4:30AM, woke to arm aching down to elbow, from elbow to fingertips, pretty good tingling. Hip to below knew, dull and numbish; from below knee thru toes, same tingling as fingers. Biggest concern was side of face and jaw; dull and numbish. All these reactions occurred on right side of body. Thursday late afternoon, the tingling and the dull and numbish diminishes but the arm aching along with inability to completely raise remains. Friday; arm remains the same Saturday; arm below injection site now feels only bruised NOTE: while I enjoy a strong immune system, by body is very sensitive to new medicines/tweaking medicines. Also applies to food. APPROX 25 years ago, I believe I contracted Gullian Barre, where the immune system attacks nervous system. There was./is no test to confirm although I continue to endure some side effects. QUESTION- with all said is it advisable to receive the 2nd vaccine shot? Please advise ASAP",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PUB,"Blood pressure-Accupril, Amlodopine and Hydrochlrithiazide Chlorestrol- Fenofibrate Diabetes - Metformin Just finished a prescription Valtrex (1000mg) cold sores",cold sore virus,"blood pressure, diabetes, chlorestrol,",,"Niacin, plastics Onions, mint","['Headache', 'Hypoaesthesia', 'Immediate post-injection reaction', 'Injection site bruising', 'Mobility decreased', 'Pain in extremity', 'Paraesthesia']",UNK,MODERNA,SYR 917472,MD,50.0,M,Dizziness started 6pm on 12/31/20.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,None,None,None,,None,['Dizziness'],1,MODERNA,IM 917473,UT,21.0,F,"Body aches, fever of 103.6",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,SEN,Junel Fe (birth control),Covid 19 on Dec 7th,,,,"['Pain', 'Pyrexia']",1,MODERNA,IM 917474,MI,58.0,F,"Peri-oral tingling, shortness of breath, nausea immediately after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,"Aspirin 81mg, Hydralazine, Zestoretic, propranolol",none,Hypertension,,Bee stings (anaphylaxis),"['Dyspnoea', 'Nausea', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 917475,WI,22.0,M,"Pt had grand mal seizure approximately 10 minutes post vaccination. Seizure lasted about 3 minutes, then another seizure resulted approximately 2 minutes later lasting about 3 minutes, then ambulance arrived. Pts blood sugar was checked and was slightly low as well according to EMS. Pt seemed to stabilize. as being brought away, but in post-ictal phase.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,SEN,Takes seizure meds and medications for diabetes,None,"Known epilepsy and diabetes, previous seizure history >1month prior.",,None,"['Blood glucose decreased', 'Condition aggravated', 'Generalised tonic-clonic seizure', 'Postictal state']",1,MODERNA,IM 917476,MA,22.0,F,"Back pain along spine and headache started during the night (about 12 hours after vaccination). It was bad enough to keep me from sleeping. I started running a fever during the night as well. I got up around 5am because I could sleep with the pain , I took my temp it was about 101. I was also nauseas. This lasted a few hours and was relieved with 600mg ibuprofen. My arm has been painful the entire time (4days now). Redness around the site has been getting larger. It started as just a small circle but after two days it started to grow to about 2?x4? and by today (day4) it covers my entire bicep and is starting to wrap around. It is also mildly itchy and swollen. On the 31st I work up with a painfully swollen axillary lymph node on the left side. It stayed swollen and painful for about a day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,WRK,"Zyrtec, multi vitamin, albuterol inhaler",None,Asthma,,No known allergies,"['Axillary pain', 'Back pain', 'Headache', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Lymphadenopathy', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 917477,TN,53.0,F,"Pink eye (conjunctivitis) in left eye. No treatment sought yet. Began the morning after the day of vaccination and has lasted for over 24 hours (at time of report, it has been approx. 30 hours since first sign of pink eye)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PUB,"Metformin, Metoprololol, Atorvastin, Losartan HCTZ, Calcium, D3, Benadryl",,"Diabetes, high blood pressure, chronic angioedema",,Zestril,['Conjunctivitis'],1,MODERNA,IM 917478,KS,32.0,F,"Throat swelling Joint pain Chills Headache Cellulitis at injection site-redness, swelling, warm, tingling in fingers",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,Adderall Junell 1/20 Trulance CBD products,None,Anxiety Migraines IBS-C,,None,"['Arthralgia', 'Chills', 'Headache', 'Injection site cellulitis', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Paraesthesia', 'Pharyngeal swelling']",1,MODERNA,IM 917479,,29.0,F,"Large bruise, pain radiating from axilla down to left flank",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/29/2020,3.0,MIL,None,None,None,,None,"['Contusion', 'Pain']",1,MODERNA,IM 917480,PA,,U,Left hand pain increased from normal arthritis pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,PVT,,,,,,"['Arthralgia', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 917481,TX,43.0,F,"Pt with urticaria, swelling to face and itching to mouth that occurred within 10 minutes of administration. She was treated with benadryl 50 mg IM upon onset of symptoms. She did not have any stridor, hypoxia, or tachycardia or hypotension. She did have a change in pulse from 70s to 100 then back to 70s 10 minutes after administration of benadryl and stated she has a paradoxical reaction to benadryl. She experienced pallor and livedo after administration of benadryl which resolved after 15 minutes. She experienced urticaria on 01/01/21 into 01/02/21 requiring continued antihistamines which did subsequently improve.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Vyvanse, multivitamin",none,none,,"shellfish, amoxicillin, iodine","['Livedo reticularis', 'Oral pruritus', 'Pallor', 'Swelling face', 'Urticaria']",1,MODERNA,IM 917482,PA,37.0,M,"fever 100.6 F (lasted ~36 hrs no anti-pyretics), myalgia, chills, headache (peaked at 24 hrs), injection site moderate soreness (decreased to mild by 72 hrs), loss of appetite, diarrhea (24-48 hrs)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,None,None,None,,Penicillin,"['Chills', 'Decreased appetite', 'Diarrhoea', 'Headache', 'Injection site pain', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917483,WI,26.0,F,"Pale and light headed. Given water, ice pack for neck. Rested and monitored for 30 minutes and left walking and without symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,none known,unknown,unknown,,unknown,"['Dizziness', 'Pallor']",1,PFIZER\BIONTECH,IM 917484,NJ,56.0,F,Rash developed on left cheek predominantly ( slightly on right side) shortly after vaccine was administered,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PHM,Vitamin D Zinc Vitamin C Flaxseed Oil Hydroxychlor 200 mg Omega-3 + FloraGLO Lutein & Zeaxanthin,None,Sjogrens Syndrome,,None,['Rash'],1,MODERNA,IM 917485,IL,26.0,F,"9:20am- mild itching on both arms and legs, No hives present 9:30am- flushed face and redness present 9:45am- pins and needle like feeling on right side of lips 10:10am-Adult Benadryl taken with Prednisone 12:54pm-3:34- Tired went to sleep 5:00pm- Shoulder pains/ aches 5:15pm- Severe headache 6:00pm-7:30pm- Chills here and there 12/31/2020 All day symptoms Lower back pain Upper back pain Ankle pains muscle Tired",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,junel fe birth control,,,,"Penicillin, Cefprozil","['Arthralgia', 'Back pain', 'Chills', 'Erythema', 'Fatigue', 'Flushing', 'Headache', 'Paraesthesia', 'Pruritus']",UNK,MODERNA,IM 917486,OR,48.0,F,"Cg received the Covid vaccine on 1/2/21 @ 1042. At 1055, cg reported palpitations, HR of 140 (Fit Bit) and was flushed. Vitals: 168/99 P 129, at 1102 155/94 P 109, at 1110 137/93 P 95. At 1110 cg reporting feeling better and left the observation area at approximately 1115. VAERS completed.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Blood pressure increased', 'Flushing', 'Heart rate increased', 'Palpitations']",1,MODERNA,IM 917487,CO,41.0,F,Pt. presented to the Urgent Care on 1/2/2021 c/o nausea since receiving the Covid 19 vaccination on 12/28/2020.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,PVT,no known,none documented,no known,,no known,"['COVID-19', 'Nausea', 'SARS-CoV-2 test positive']",UNK,MODERNA, 917488,CA,45.0,F,"Swollen lips, under left eye. Rushes on chest",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,No,,No,,"Avocado,Bananas No","['Eye swelling', 'Lip swelling', 'Rash']",1,MODERNA,IM 917489,SD,77.0,F,"My right eye became very painful, hurt and felt scratchy until 12/31/2020. My arm still aches and it is 1/2/2021. I also ache everywhere and still do. I am extrememy tired all the time and at times have to lie down. On going.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,"Losartan 100 mg, Metoprolol Succinate ER, 50 mg, Hydrozxyzine HCL, Gabapentin, Hyland's Restless Leggs, Hyland's Leg Cramps, Tylenol 500mg and Advil Dual Action, took these on the 28th",None,"Copd, vascular problems, Fibromyalgia, small fiber neuropathy, Macular Degeneration","Shingrix, age 76","Soy, Dust, pollen, trees, grasses, bushes, mostly hay fever. Vancomycin, Pennicillin, Sulfa, Floxin, Levaquin, EES400, Statins","['Eye irritation', 'Eye pain', 'Fatigue', 'Pain', 'Pain in extremity']",UNK,MODERNA,SYR 917490,CA,63.0,F,"Approximately 1 hours after injection, I felt an unusual feeling at base of throat. It progressively got worse and I felt throat swelling and my voice was effected. No itchy throat like my anaphylaxis reaction to shellfish only swelling. I mildly panicked and wanted to take Benadryl. About 1/2 hour later by the time I got home reaction was over. No repeat of symptoms ever again.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,OTC. Prilosec 1 tablet daily Synthroid 100mc 1 tablet daily Losartan Hctz 50-12.5 1/2 tab daily,None,Hypothyroidism High blood pressure,,Calamari anaphylaxis Shellfish ? Vicodin hives Asparagus hives,"['Dysphonia', 'Pharyngeal swelling', 'Throat irritation']",1,PFIZER\BIONTECH,IM 917491,NY,54.0,F,"7+ days posts injection, I developed red, hard, hot area at injection site. Redness is fading. Hard/swelling lasted about 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,PVT,"Synthroid, vitamin B12,D3, multivitamin",none,hypothyroid (2012 thyroidectomy),,"dilaudid, clindamycin","['Injection site erythema', 'Injection site induration', 'Injection site warmth']",1,MODERNA,IM 917492,,39.0,F,I am currently breastfeeding feeding and since receiving my daughter has a bad eczema flair. I have pictures if needed.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,MIL,OTC Prenatal,None,Cardiac,,None,"['Eczema', 'Exposure via breast milk']",1,MODERNA,IM 917493,NY,28.0,F,Hives on L wrist,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/02/2021,1.0,PVT,Levothyroxine,,Hypothyroidism,,Penicillin,['Urticaria'],1,PFIZER\BIONTECH,IM 917494,TX,49.0,F,"Sweating; ""Feels clammy""; Nausea; Elevated blood pressure (189/112 and Pulse 76); Dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PHM,Wellbutrin XL; Effexor XR; Labetalol; Simvastatin; Levothyroxine; Nifedipine ER; Biotin,None,High blood pressure; Depression; High cholesterol; Thyroid deficiency,,Compazine; Latex,"['Blood pressure increased', 'Cold sweat', 'Dizziness', 'Hyperhidrosis', 'Nausea']",1,MODERNA,IM 917496,CO,30.0,F,"Very severe body aches and feeling lightheaded, causing fall on the ice",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/01/2020,0.0,PVT,,,"Migraines, sinusitis","Age 7, fainted, hib vaccine",,"['Dizziness', 'Fall', 'Pain']",1,PFIZER\BIONTECH,IM 917497,GA,30.0,F,"Vaccine given at 7:05am 12:00noon, 5 hours later, I started experiencing severe chest pain, jaw pain and shortness of breath in which EMS was called and I was taken to the hospital. Since then, I lost feeling in my hands and feet, numbness and tingling. I've improved however, during my recovery suffered with spinal pain, shortness of breath, very winded, muscle pain and loss of appetite to especially meat.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,None,None,None,,No known,"['Chest pain', 'Decreased appetite', 'Dyspnoea', 'Hypoaesthesia', 'Myalgia', 'Pain in jaw', 'Paraesthesia', 'Spinal pain']",1,PFIZER\BIONTECH,IM 917499,KS,66.0,F,Patient had transient vasovagal response after the injection with light head feeling and tinnitus. Resolved within 30 minutes. Normal vital signs.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,"Clonazepam, singulair, omeprazole, spiriva, vit d, asa, atorvastatin, citirizine, flonase.",COPD exacerbation 1 week prior,"copd. insomnia, gerd, anxiety, ibs, hep c, htn",,NKA,"['Dizziness', 'Presyncope', 'Tinnitus']",1,MODERNA, 917500,TX,67.0,F,Sore arm ??,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,Aleve,None,Diabetes and hypertension,,Atarax,['Pain in extremity'],1,PFIZER\BIONTECH,IM 917501,FL,38.0,F,"On day 7 , Swollen lymph node under left armpit, day 7, swelling and rash at injection site, day 7 tiredness, headache on day 6 .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,WRK,"Junel Fe 1.5/30, Acyclovir 400 mg, vita fusion multivitamin",None,None,,Sulfa,"['Fatigue', 'Headache', 'Injection site rash', 'Injection site swelling', 'Lymphadenopathy']",1,MODERNA,SYR 917502,CA,56.0,F,"Fever of 102 F x 2 days, Chills, Left arm extremely sore to point of inability to lift x 4 days , Headache and general weakness/dizziness x 4 days, Treatment with Advil for fever, fluids, rest.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"MULTIVITAMINS, FISH OIL SUPPLEMENT, LUTEIN","HAD COVID SYMPTOMS BEGINNING OF DECEMBER, FEVER, CHILLS, LOSS OF TASTE AND SMELL. COVID TEST NEGATIVE.",NONE,,NONE,"['Asthenia', 'Chills', 'Dizziness', 'Headache', 'Injected limb mobility decreased', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 917503,IN,23.0,F,"Vomiting, nausea, neck muscle tightness, throat tightness and muscle soreness of back of tongue, severe disorientation, blurred vision, neck soreness, diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,WRK,"Lactulose, apri, turmeric with black pepper, omega 3, green tea extract, resveretrol, avocado oil, olive oil, b12, vitamin c, cinnamon, probiotic",None,Constipation and endometriosis,,None,"['Diarrhoea', 'Disorientation', 'Glossodynia', 'Muscle tightness', 'Myalgia', 'Nausea', 'Neck pain', 'Throat tightness', 'Vision blurred', 'Vomiting']",1,MODERNA,IM 917504,TX,,U,Feverish aches in ankles elbow and back. Injection site is red and swollen and hot.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,PUB,,,,,,"['Arthralgia', 'Back pain', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Pyrexia']",1,MODERNA,IM 917505,CA,39.0,M,"Patient became lightheaded, clammy and passed out (typical vagal reaction). Patient aroused easily, VS monitored.... patient was able to sit up after about 5 minutes. Monitored for 30 minutes post vaccination. Patient did not need any other intervention or care.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,,,,,Bupropion,"['Cold sweat', 'Dizziness', 'Loss of consciousness', 'Presyncope']",1,PFIZER\BIONTECH,SYR 917506,MI,29.0,M,"He received his vaccination 1/2/21 at 1100. He experienced a racing heartbeat up to 150 when sitting in the monitor room that did return to normal during 15 minutes and he was asked to wait 30 minutes to continue to be monitored. He was feeling better but, when he went to walk up the stairs he began to feel light headed again. He was taken to the ER at 1218 for lightheadedness and racing heartbeat. Vitals taken in the Emergency Department - Temp 97.7F, Heart Rate - 78, Resp Rate 16, Blood pressure 127/63. EKG - normal sinus rhythm. He felt fine and was discharged at 14:06 .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,WRK,None,None noted,None,,None,"['Dizziness', 'Electrocardiogram normal', 'Metabolic function test normal', 'Palpitations']",1,PFIZER\BIONTECH,IM 917507,CA,35.0,F,"On December 31, 2020 at around 530PM I felt a discomfort on my left jaw that lasted for couple hours, and at around 9PM I felt a stabbing pain on my whole left arm, I took Acetaminophen 500 mg 2 tabs without relief. The pain lasted 'til dawn, fell asleep and woke up and pain was gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,PVT,none,None,None,,NKA,"['Jaw disorder', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 917508,MT,47.0,F,"Received covid-19 vaccine on 12/17/2020. On 12/23/2020, noticed small rash bumps on back of both hands. On 12/26/2020, noticed rash on shoulders and middle back. Noted fatigue and malaise. No fever. On 12/28/2020, rash appeared on upper legs and back of both knees. Noted fatigue and malaise. No fever. On 12/29/2020, rash appeared on both lower legs and on arms. Noted fatigue and malaise. No fever. On 12/30/2020, attempted to make an appointment with primary care provider and was unable to be seen before Jan 6, 2021. On 1/1/2021, went to Urgent Care for evaluation and treatment of full body rash. The only part of my body not affected by the rash is my face. Was prescribed a methylprednisolone dose pack.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/23/2020,6.0,PVT,"Mesalamine, lithium, lamotragine, birth control pill",none,Ulcerative colitis,,Sulfa medications,"['Fatigue', 'Malaise', 'Rash']",1,PFIZER\BIONTECH,IM 917509,FL,27.0,F,"Severe Migraine, malaise, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,OTH,None,None,None,,"Latex, kiwi, bananas","['Malaise', 'Migraine', 'Nausea']",1,MODERNA,IM 917510,VT,25.0,F,"Almost immediately to maybe 3 minutes after I received the vaccine my tongue started tingling and the sides of my tongue began to burn. I also had a slight red rash on my chest that began to burn and itch. These are similar to the reaction I have after I eat cinnamon. It wasn?t severe like my shellfish allergy where I go into anaphylactic, but it was definitely a reaction. My tongue was then slightly swollen that day into the next day. Very slightly swollen. Just enough that I noticed it because I kept biting my tongue. The burning and tingling lasted for maybe an hour after. I was slightly dizzy as well, but nothing too bad. I was seen by the ER team to make sure I didn?t go into anaphylactic and then I was allowed to return home. Others I walked by stated my face was bright red and I got very hot. Following that I had extreme exhaustion. I couldn?t even make it home without having to pull my car over to try and wake myself up. I am feeling fine now, but just wanted to make this known for study purposes. I plan on getting the second shot on 1-19-21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,UNK,None on the day of vaccination,None,"Asthma, allergies , raynauds",,"Shellfish, tomatoes, string beans, and cinnamon","['Chest pain', 'Dizziness', 'Erythema', 'Fatigue', 'Feeling hot', 'Immediate post-injection reaction', 'Impaired driving ability', 'Paraesthesia oral', 'Rash', 'Rash erythematous', 'Rash pruritic', 'Somnolence', 'Swollen tongue', 'Tongue biting', 'Tongue discomfort']",1,PFIZER\BIONTECH,IM 917511,GA,43.0,F,"Chills, body aches, fevers, cough, sore throat, fatigue started the evening of my vaccination. Fever up to 100.5 today. At home treatment with Tylenol, rest & po fluids.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,Tylenol PM Xidra Eyedrops,,,,Phenergan,"['Chills', 'Cough', 'Fatigue', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 917512,CA,41.0,F,"Day after vaccine experienced weakness, chills fatigue. Day four felt better went snowboarding and balance was off and fell several times. Body aches and pain continued. 12/29/2020 at 8 pm had fever of 100. 12/30 fever 103f chills, slept almost all day loss of appetite. 12/31 no fever in the morning but acting different than normal. In after non could not tell my husband child?s name went to the ED where I was admitted for altered mental status. Discharge today with altered mental status, unspecified. Wife still has headache but normal level of consciousness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,Fluoxetine HCL 60mg,None,Depression,,None,"['Asthenia', 'Balance disorder', 'Chest X-ray', 'Chills', 'Computerised tomogram', 'Decreased appetite', 'Fall', 'Fatigue', 'Headache', 'Laboratory test', 'Lumbar puncture', 'Mental status changes', 'Pain', 'Pyrexia', 'Somnolence']",1,PFIZER\BIONTECH,IM 917513,NY,41.0,F,"Vaccine was given at 10:30 am on 12/29/20. The injection caused mild discomfort at the site (right deltoid) followed by swelling, redness, warmth, and soreness. The swelling, redness, warmth, and tenderness to touch worsened by 24 hours, peaked at 48 hours, and has since improved (but continued well over 120 hours post vaccination). Other than the arm discomfort, I felt well the rest of the first day however I woke at 1:30 am (15 hours post-vaccine) with severe muscle cramps in my lower legs and feet. I was freezing and had significant chills. PJs, a robe, and 3 blankets weren?t cutting it. I took Ibuprofen 600 mg and a robaxin 750 mg because the cramps were severe and unrelenting. Tmax was 100.5. Sleep was poor and intermittent. I got out of bed around 24 hours post vaccination and was extremely nauseous and weak. I took Zofran 4 mg and Tylenol 500mg and laid around the rest of the day. I forced some food down at hour 29 (had not eaten in 20-21 hours). My eyes and the injection site were itchy prompting me to take Benadryl 25 mg at hour 22. I got a second round of shaking chills, nausea, and worsened myalgias at hour 32. I also felt as though the injection site pain migrated towards my right axilla. Took a second dose of Ibuprofen 400 mg, Zofran 4 mg, and robaxin 750 mg and fell asleep by 7:30 pm (unheard of for me). When I woke to go to work at 6:30 am (44 hours post vaccine) I was still very achey and fatigued. My right axilla was very sore and tender to touch, moreso than the injection site. This same discomfort migrated to the right side of my neck and behind my right ear (which was worse by hour 55 and brought on a headache). Thank goodness it was a short shift due to the holiday! While caffeine and a third dose of ibuprofen and Zofran help me through the 6.5 hour shift I was still not myself. The fatigue and achiness did not let up until a little after 96 hours. I really didn?t feel like myself until day 5 (118 hours post vaccination) and the injection site and my right axilla are still sore and tender to touch. There is still redness and occasional itchiness at the injection site. I took my usual doses of Advair and Claritin despite the nausea all 5 days. I should also mention, that while on shift (hour 48-ish), I felt a very brief, unprovoked heaviness in my chest similar to the sensation I felt after I recovered from COVID in March. Sensation lasted seconds and came a few times throughout the day. No SOB, diaphoresis, or wheezing. That same discomfort started 2.5 weeks after I was diagnosis with COVID and about 5 days after feeling ""fully recovered"" from the fever, body ache, fatigue and nausea I had experienced with COVID. That chest sensation would come and go with decreased frequency over 6 weeks post COVID. I?ve had a total of 5 episodes of the chest heaviness but none today (day 5). I wonder if that?s what will happen with the vaccine. I also wonder if the side effects I?m feeling have anything to do with having had COVID 9 months ago. My husband and other ED colleagues who did not have COVID had no side effects with the first dose of the vaccine but the few colleagues that had COVID all had some degree of an adverse reaction to the vaccine. I never want to feel as bad as I did in March but I?m dreading my second dose of the vaccine. Is it recommended in my case? I should also mention, I had an adverse reaction to the pneumonia vaccine 1.5 years ago - arm blew up, no respiratory symptoms. Needed Benadryl and Prednisone. I?ve had a MMR booster and flu shot since with no adverse reaction. Not sure if it is relevant.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,"Camrese, Advair, Phentermine, Claritin, Multi-vitamin",None,Allergen induced asthma,"Pneumovax 23 - 25 cg/0.5ml - 10/2/19 (age 40) - entire upper arm became hot, red, swollen, within 24 hours of vaccination","Oral sulfa, optic aminooglycosides, pneumonia vaccine, cats","['Asthenia', 'Axillary pain', 'Chest discomfort', 'Chills', 'Ear discomfort', 'Eye pruritus', 'Fatigue', 'Feeling abnormal', 'Feeling cold', 'Headache', 'Injection site discomfort', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Muscle spasms', 'Musculoskeletal discomfort', 'Myalgia', 'Nausea', 'Pain', 'Poor quality sleep', 'Tenderness']",1,MODERNA,IM 917515,VA,45.0,M,started with pain at the injection site on my left deltoid I also felt a little lightheaded and dizzy for a little while than I started having pain in my arm and turned to numbness and tingling,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,none,"toe pain , ? gout ; took Indomethacin for a few days . Medication was stopped a few days before vaccination","RIS, recurrent idiopathic pericarditis",,Kiwi,"['Dizziness', 'Hypoaesthesia', 'Injection site pain', 'Pain in extremity', 'Paraesthesia']",1,MODERNA,IM 917516,MS,33.0,F,"at time of injection pt felt a cold tingling sensation down right arm, sensation went away shortly after vaccine. the next day pt had arm pain, HA, fatigue, and nausea. then slowly the tingling to the right arm returned along with redness and warmth of injection sight and pain to right axiallary region",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/29/2020,3.0,UNK,"Multivitamins, vitamin c, zyrtec, omeprazole",none,none,,minocycline,"['Axillary pain', 'Fatigue', 'Feeling cold', 'Headache', 'Injection site erythema', 'Injection site warmth', 'Nausea', 'Pain in extremity', 'Paraesthesia']",UNK,MODERNA,IM 917517,NC,61.0,M,"102 fever, chills, body ache and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,"Synthesis, allopurinol, folic acid, melixicam","Positive for covid on November 30, 2020",None,,Cipro,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA, 917518,OH,22.0,F,"nausea, dizziness, emesis. patient went home early to rest as she did not have any other major adverse effects",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PHM,,,,,,"['Dizziness', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 917519,IN,34.0,F,"Moderna COVID-19 Vaccine Around 13 minutes following injection, I developed a rapid heart rate and dizziness. After 25 minutes or so, the heart rate decreased. The dizziness lasted several hours longer. At this time, 7 hours following vaccination, there is still mild dizziness but heart rate is normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,none,,,,none known,"['Dizziness', 'Heart rate increased']",1,MODERNA,SYR 917521,MA,45.0,F,"Next morning had unilateral headache minimal, that fluctuated for entire day from minimal to moderate intensity. When headache was moderate in nature had unilateral neck muscle pain as well on same side as headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/02/2021,3.0,WRK,"multivitamin, omega, vitamin C, vitamin D, zinc, quercetin, gabba",None,Can get headaches prior to menstruation.,,Loryna,"['Headache', 'Myalgia', 'Neck pain']",1,MODERNA,IM 917523,NM,58.0,F,Dry throat Cough Back pain Muscle aches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PHM,Progesterone No thyroid Duloxetine Iodine Spironolactone,None,Psoriasis Psoriatic arthritis,,None,"['Back pain', 'Cough', 'Dry throat', 'Myalgia']",1,MODERNA,IM 917524,VA,53.0,F,Fever lethargy chills. Headache. Shortness of breath,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/31/2020,01/31/2020,0.0,MIL,Candesartan 8 mg. Cranberry capsule. Biotin. Vitamin d,None,History of kidney cancer,,None,"['Chills', 'Dyspnoea', 'Headache', 'Lethargy', 'Pyrexia']",1,MODERNA,IM 917525,TX,79.0,F,"This vaccine was administered on 12/23/2020. On 12/30/2020 I experienced intermittent headaches (waking me during the night), very heavy pressure between the breasts, fatigue and extreme redness, swelling, itching at injection site. I went to emergency clinic on 1/1/2021. The performed blood work, EKG, Chest X -Ray, took vital signs and all were normal. All symptoms have disappeared as of today, 1/2/2021, except the redness and extreme tenderness at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PVT,Estradiol 0.5 - 1 daily Metoprolol SUCC ER 50 - 1 daily Vytorin 10-20 - 1 daily Diovan HCTRA 160-25 - 1 daily,NONE,NONE,,NONE,"['Blood test normal', 'Chest X-ray normal', 'Chest discomfort', 'Electrocardiogram normal', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Sleep disorder']",2,MODERNA,IM 917526,ME,26.0,F,"1 week after vaccine; redness, swelling, hard to touch, itching all around injection site with associated pain with movement and pressure on arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/01/2021,8.0,UNK,Amethyst Birth Control Sertraline,,,,,"['Erythema', 'Induration', 'Injection site pruritus', 'Limb discomfort', 'Pain', 'Swelling']",UNK,MODERNA, 917527,NY,35.0,F,"Chest pain, chills, headache, sore throat, weakness, joint pain, muscle pain (at the site of injection). Treatment: Acetaminophen 1000 mg (1 g)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,Women multivitamin complex,None,Asthma,,,"['Arthralgia', 'Asthenia', 'Chest pain', 'Chills', 'Headache', 'Injection site pain', 'Oropharyngeal pain']",1,MODERNA,IM 917528,OR,55.0,M,"Fever, chills, body aches, headache. Lymph node in right armpit swollen to size of a baseball. Have not received treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,WRK,,,,,,"['Chills', 'Headache', 'Lymphadenopathy', 'Pain', 'Pyrexia']",1,MODERNA,IM 917529,IL,83.0,M,"Two days following the dose I felt light headed and was lying in bed most of the time for 2 days, since then I am ok.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,Levothyroxine 75 micrograms daily. Esomep0rasol 20 mg every other day.,Migraine,No,,Penicillin,['Dizziness'],1,MODERNA,IM 917530,OK,26.0,F,"Fever of 101, chills, severe body aches, mild headache, nausea, pain at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,Zoloft,,Anxiety,Mild Body aches after flu shot,None,"['Chills', 'Headache', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 917531,NJ,20.0,M,"Severe headache, severe nausea, temperature control issues, cough, aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PHM,None,None,Asthma,,No known allergies,"['Cough', 'Headache', 'Nausea', 'Pain', 'Temperature regulation disorder']",1,MODERNA,SYR 917532,OH,28.0,F,"Twelve hours post injection: fever, aches, chills, arm pain. 36 hours post injection: lymph node swelling, redness, left arm tingling, edema",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,Nuva ring.,Time of vaccination: NA Tested positive for covid on 11/16/20.,Asthma.,,"Animal dander, pollen. No food or medication allergies.","['Chills', 'Erythema', 'Lymphadenopathy', 'Oedema', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Pyrexia']",1,MODERNA,SYR 917534,TX,57.0,F,"Mild pain at injection site, 5 days after injection, I developed herpes sores on my lip.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,PUB,"Effexor, amlodipine,losartan, armodafanil, hydroxychoriquine, zinc,vitamins cAnd d",NONE,"SLE, Sjogrens syndrome,hypertension",,"Minocycline, sulfa drugs","['Cheilitis', 'Injection site pain', 'Oral herpes']",1,MODERNA,IM 917535,MI,25.0,F,"She became flushed with tachycardia, then nauseated. Skin pale. Face is itchy. No shortness of breath. Symptoms started 20 minutes following administration of vaccine and resolved about 30 minutes thereafter. EMS came - thought it could be related to anxiety.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/02/2021,1.0,PVT,Premedicated with liquid Benadryl 30 mg and famotidine OTC,Mast cell activation syndrome EDS,See above,influenza x 2 (then no reactions for several years),Shellfish Vancomycin Metoprolol,"['Electrocardiogram normal', 'Flushing', 'Nausea', 'Pallor', 'Pruritus', 'Tachycardia']",1,PFIZER\BIONTECH,IM 917536,AR,58.0,F,Patient experienced itchiness at the site of the injection under the bandaid and PPE. She was given benadryl orally and did not complain of the event any further in the 6 hours I saw her.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,SEN,,,,,,['Injection site pruritus'],1,MODERNA,IM 917537,NH,46.0,F,"This evening, I noted a large red ring around the injection site on my right arm. Red ring is slightly raised. Lesion is asymptomatic. Diameter 2-3 inches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/02/2021,10.0,PVT,"atorvastatin, metformin, fexofenidine",none,pcos,,"nkda, environmental",['Injection site urticaria'],1,MODERNA,IM 917538,IA,36.0,F,"12hr after shot I have experienced nausea, vomiting, headache, stiff neck, aches and pains, trouble sleeping, feeling like I have a fever but do not, sweating profusely",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,,,PVT,welbutrin fluoxetine lorazepam phentermine,psudogout flair up,anxiety depression,,none,"['Headache', 'Hyperhidrosis', 'Insomnia', 'Musculoskeletal stiffness', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 917539,IA,68.0,M,Seizure,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,SEN,,,,,,['Seizure'],1,PFIZER\BIONTECH,IM 917540,VA,40.0,F,"starting 10 minutes after the vaccine was given my mouth was very briefly tingling, warm wave came over me, my heart starts to race and del lightheaded. they told me to lean back and relax and it went away in less than a minute.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,,miscarriage,,,nka,"['Dizziness', 'Feeling hot', 'Palpitations', 'Paraesthesia oral']",1,MODERNA,IM 917541,,59.0,F,Patient experienced itchiness at the site of the injection under her band-aid and PPE. Patient was given oral benadryl and did not complain of the event further when I saw her the remaining 6 hours of work.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,SEN,,,,,,['Injection site pruritus'],1,MODERNA,IM 917542,LA,26.0,F,"Vaccine was administered at 12:15 pm on 12/29/2020. I continued to work the remainder of the day. I began to feel fatigue around 7 pm that afternoon and fell asleep. When I woke up at midnight on 12/30/20 I noticed numbness beginning in my left foot and spreading into my face over a course of 30 minutes. I never noted any muscle weakness, but felt a tingling sensation on the left side of my body. Then I began to experience chills and sweating. I was able to return to sleep around 2 AM. When I woke up at 5:30 the numbness had resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,Aurovela Fe 1.5/3,None,None,,Sulfa,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 917544,PA,45.0,F,"Less than one hour after receiving COVID-19 vaccine, patient arrived at the ER stating her face felt hot, lips tingling/swollen and chest red. Denies any issues with breathing.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Levocetirizine Buspar Levonorgestrel Multivitamin,None Known,None Known,,Nuts Bee Stings,"['Erythema', 'Feeling hot', 'Lip swelling', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 917545,TX,27.0,F,Patient began to feel light headed immediately after vaccine was given. She noted ringing ears and dizziness. She No epinephrine was given and she was able to walk out after ten minutes of sitting with head held forward.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,SEN,,,,,,"['Dizziness', 'Tinnitus']",1,PFIZER\BIONTECH,IM 917546,MA,66.0,F,left shoulder pain difficulty raising arm pain rated as 8 apply ice take tylenol and motrin which dose help for short time pain and difficulty raising arm has not lessened in 10 days,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,metformin 1000mg daily,,,,compazine,"['Arthralgia', 'Mobility decreased']",UNK,MODERNA,IM 917547,MA,68.0,M,Pt had 2 hours of atrial fibrillation for first time starting 7 hours after the shot and lasting 2 hours-had never at it before,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,UNK,,None,CHF,,None,['Atrial fibrillation'],1,PFIZER\BIONTECH,IM 917548,CT,59.0,F,"When I first got the injection I had a slight sensation through my left neck gland to my ear. Felt fine as the days have progressed my neck gland has become very swollen especially as of today 1/2/2020 and a fullness in that ear, tonight had a sharp pain from that area Otherwise feel fine. The neck gland has become very tender. Please advise",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Propranolol, mobile, clonazepam","Was positive for covid on November 4 2020, had antibody test done dec 28 2020 which showed antibodies.","Nystagmus causing ataxia, migraines",,Chlor prep surgical cleanse,"['Discomfort', 'Ear discomfort', 'Ear pain', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,SYR 917549,CA,41.0,M,Soreness and weakness of left arm for more than 5 days. Intermittent headaches and runny nose,Not Reported,,Not Reported,Not Reported,,Yes,N,12/28/2020,12/28/2020,0.0,WRK,,,,,,"['Headache', 'Muscular weakness', 'Pain in extremity', 'Rhinorrhoea', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH,IM 917552,CA,51.0,M,Injection site pain.. extremely tired fell asleep at 1130am awoke at 3:55 pm,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,UNK,,,,,,"['Fatigue', 'Injection site pain']",UNK,PFIZER\BIONTECH,IM 917554,CA,56.0,F,"headache, muscle pain, mostly in left calf area started few days after, hypertension (new onset), chest tightness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,PVT,Levoxyl 100mcg Daily,NKA,"Hypothyroidism, Sjogren's, IGA deficiency, anxiety",,,"['Chest discomfort', 'Headache', 'Hypertension', 'Myalgia', 'Ultrasound Doppler']",2,PFIZER\BIONTECH,IM 917555,CO,55.0,F,"About five hours after injection, my face turned red and felt like a very bad sunburn. I also had blotchy red hives on my arms, hands, abdomen and legs. I had taken Benadryl at 9;3 0 am and my injection was about 11 AM. I went to Health. At the clinic I was told to go to the ER. At the ER, a nurse checked my vitals and a doctor looked in my mouth. Other than the hives, everything was normal. I was advised that all they could do was give me more Benadryl. Since they were overwhelmed with trauma patients, I chose to go home. I took more Benadryl and within about 4 hours, the redness and hives went away.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,Lidocaine-Prilocaine Cream PRN Hydrocodone-Acetaminophen 5-325 mg 2 daily Levothyroxine 88 mcg 1x PM Tramadol 50 mg 2 twice daily Liothyronine 5 mcg 1x AM Montelukast 10 mg 1x AM Zolipidem 10 mg 1x PM Symbicort 80/4.5 2 puffs 2x daily Vento,C,Fibro-Care 2 capsules twice daily Melatonin 10 mg PM Tumeric Curcumin 2 twice daily Multi-Gold Vitamin B-50 Complex Quercitn Bromelain ES B-12 Methylcobalimin 1000 mcg twice daily Vitamin D3 2000 IU in am,,"Tomatoes, Wheat, Sulpha ATB","['Burning sensation', 'Erythema', 'Rash macular', 'Urticaria']",1,MODERNA,SYR 917556,CA,62.0,F,Severe left upper extremity pain and fatigue for two days after that I took two Tylenol?s and all the symptoms subsided,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,OTH,"Tirosint, arimidex, Omega three and seven ,vitamin E Vitamin A-Vitamin B 12, immucore , vitamin K2 , Curcumin Magnesium , calcium , vitamin D three , Metformin.",,"H/ o breast cancer , lobular cell ca stage 2 negative nodes H/o Graves disease status post radio ablation Glucose intolerance",,Streptomycin,"['Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 917557,MI,40.0,F,itching sensation. No rash. No shortness of breath. No anaphylaxis.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,,none,"eczema, asthma, fibromyalgia",,"codeine, nickel, sulfa.",['Pruritus'],UNK,PFIZER\BIONTECH, 917558,,29.0,F,"Developed multi-dermatomal shingles and moderate-severe abdominal . Preliminary read of the CT states - ""Minimally distended loops of small bowel with bowel wall thickening and mucosal hyperenhancement, likely enteritis. Normal large bowel.""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,Fluvoxamine,None,None,,None,"['Abdominal discomfort', 'C-reactive protein', 'Computerised tomogram', 'Enteritis', 'Full blood count', 'Herpes zoster cutaneous disseminated', 'Laboratory test normal', 'Lipase', 'Liver function test', 'Respiratory viral panel', 'Urine analysis']",1,MODERNA,IM 917559,NY,49.0,F,"Approximately 24 hours after administration, developed sudden onset of severe headache, nausea, severe abdominal cramps, followed by generalized body aches, pallor, 'brain fog', and approximately 4 hours later had stabbing chest pain on inspiration. Majority of symptoms passed within 8 hours. Brain fog, headache and fatigue lingered through 12/30/20.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/28/2020,1.0,PVT,,,,,Maxalt,"['Abdominal pain', 'Chest pain', 'Fatigue', 'Feeling abnormal', 'Headache', 'Nausea', 'Pain', 'Painful respiration', 'Pallor']",1,MODERNA,IM 917560,WA,51.0,M,"Fatigue on 12/28/2020, Fever (101.4F) on 12/30/2020, positive COVID test results on 01/2/2021, loss of smell on 1/2/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/28/2020,9.0,PVT,,,,,"Seasonal allergies, sensitivity to Lidocaine.","['Anosmia', 'COVID-19', 'Fatigue', 'Influenza virus test negative', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 917561,PA,63.0,F,"site of injection-red, hot, raised area, temp 101.4 x 1 day headache, nausea x3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,None,,,,None,"['Body temperature increased', 'Headache', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Nausea']",1,MODERNA,IM 917562,CA,37.0,F,"Patient developed site injection (left arm), then headache, body aches, joint pain, and dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,Advair Albuterol,none known,Asthma,,Penicillin Ibuprofen Codeine,"['Arthralgia', 'Dizziness', 'Headache', 'Pain']",UNK,PFIZER\BIONTECH, 917563,IA,69.0,F,"Metallic taste in mouth as it was being administered. I told them I could taste it. Eyes started hurting with burning sensation, pressure in both ears and slight numbness across face from ear to ear and under nose. Uncomfortable tightness in chest and a lot of pressure on face feeling like it was hot. I felt a little better after 15 minutes while waiting but never told anyone about symptoms. I walked out and drove home but monitored my symptoms. The symptoms gradually became less and were gone after 1 hour and 45 minutes. I took a dose of benadryl at that time. I slept well that night and woke up with no symptoms and none since.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,Metoprolol Succinate Clopidogrel Pantoprazole Hydrochlorothiazide Selenium Vitamin D,None,Mitral Valve regurgitation Symptomatic PVC's Osteoarthritis Bilateral breast cancer 20 years ago,,None,"['Chest discomfort', 'Dysgeusia', 'Ear discomfort', 'Eye irritation', 'Feeling hot', 'Hypoaesthesia']",UNK,PFIZER\BIONTECH,SC 917566,,59.0,M,"Patient felt ""flush"" sensation immediately after vaccination. Flush lasted ""30 seconds"" and went away. Five minutes later, patient reported ""fast heart rate for 30 seconds"" and went away. He stated the fast heart rate was likely from being more aware of his body. He was monitored for 15 minutes and reported feeling well. No other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,UNK,,,,,,"['Flushing', 'Heart rate increased']",1,MODERNA,IM 917567,CA,51.0,F,"Lots of dizziness and nausea. Even after a long nights rest, the dizziness does not go away. The dizziness began the day of vaccine around 8pm and has not subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,WRK,Nortriptyline,None,"Arthritis Rheumatoid, Fibromyalgia",,None,"['Dizziness', 'Nausea']",1,PFIZER\BIONTECH,SYR 917568,MA,33.0,M,Left side of face swelling in cheeks and gums. I wasn?t experiencing this pain or issue before shot.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,None,None,None,,Shellfish,"['Gingival swelling', 'Pain', 'Swelling face']",1,MODERNA,IM 917569,IA,58.0,M,Developed hives over my body about 14 hour after injection and still present at this time. Using benadryl every 4 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,SEN,"Paxil, multivitamin",none,,,none,['Urticaria'],1,PFIZER\BIONTECH,IM 917570,WI,46.0,F,"Acute onset of reactogenicity reaction as patient was leaving grocery store. Almost crashed car driving due to violent rigors. Single episode explosive diarrhea upon arrival home. Patient incapacitated on couch for 3.5 hours due to shaking chills, dizziness, headache, profound weakness, near syncope when attempting to get up. Patient unable to reach phone to summon help for over an hour. (phone was only 2 feet from patient).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,None,None,Hayfever,,"Patient receives allergy immunotherapy injections for allergies to dust, molds, ragweed, grass, trees, grass, cats. She had received her injections on 12-29-20 at 1:15pm","['Asthenia', 'Chills', 'Diarrhoea', 'Dizziness', 'Headache', 'Impaired driving ability', 'Mobility decreased', 'Presyncope', 'Reactogenicity event']",1,PFIZER\BIONTECH,IM 917571,CA,38.0,F,Pain and itching at injection site after about 2-4 hours lasted to the next day approximately 24 hrs Face flushing started about 2-4 hours after vaccine and lasted only about 4 hours. Nausea started about 6 hours after vaccine and lasted about 10 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,UNK,None,None,None,,Doxycycline monohydrate Plan b,"['Flushing', 'Injection site pain', 'Injection site pruritus', 'Nausea']",1,PFIZER\BIONTECH, 917572,OH,24.0,F,"3 days of muscle pain and fatigue. Day 6 had severe collarbone area pain and found a hard inflamed lymph node same side as vaccine. Now day 9 continuing lymph node pain plus a large hot, red, painful swelling 3 1/2 inches in diameter located 2-3 inches below the injection site. My entire arm is a dull ache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/25/2020,12/30/2020,5.0,PVT,"Amitriptyline, stelara, birth control, probiotic",,Crohns,Flu vaccine,"Nubain, sulfa, morphine, fluticazolone, azithromycin,latex, nutmeg","['Arthralgia', 'Fatigue', 'Induration', 'Inflammation', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Lymph node pain', 'Myalgia', 'Pain', 'Pain in extremity']",1,MODERNA,IM 917573,OR,36.0,F,"Patient become light headed within minutes of vaccination. BP 12/83, HR 88. Resolved on its own. CG left in stable condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,,,,,,['Dizziness'],1,MODERNA,IM 917574,CT,32.0,F,"Red, hard, hot area at injection site 7 days after injection. Area was normal until 7 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,PVT,None,None,None,,None,"['Injection site erythema', 'Injection site induration', 'Injection site warmth']",UNK,MODERNA,IM 917576,MD,51.0,F,"Upper lip numbness and tingling that started within first 30 minutes after injection, and difficulty initiating a swallow with sensation of mild swelling in posterior oropharynx with onset approximately 45 minutes after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,"metoprolol, Vyvanse",,"ADHD, HTN",,"Anaphylaxis with Compazine, angioedema with lisinopril","['Dysphagia', 'Hypoaesthesia oral', 'Pharyngeal swelling']",1,MODERNA,IM 917578,OH,31.0,F,"A few hours after receiving the vaccine I noticed typical arm soreness associated with vaccines. However, this time I also noticed there was a cold tingling feeling in my arm, leg, and toes on the left side of my body (injection side). It happened on and off and lasted for a few minutes at a time. It was not bothersome and resolved within 24 hours. Soreness the next day was worse than with any vaccine received prior (including tetanus shot) and limited range of motion but did not interfere with activities of daily living.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,"Elmiron 100mg 1 QAM, 2 QHS; fexofenadine 180mg QD; Camrese birth control QD; Multivitamin QD; pantoprazole 40mg QAM",,"Interstitial Cystitis, GERD",,,"['Pain in extremity', 'Paraesthesia']",UNK,PFIZER\BIONTECH,IM 917580,CA,41.0,F,"Heart palpitations and tachycardia. BPM 102. Lasted for at least 30 minutes. Drank 8 ounces of water, practiced deep breathing and went back to bed lying on left side. Eventually was able to fall asleep so unsure of total duration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/02/2021,1.0,PHM,"Multivitamin, Vit D, Zinc, Vit C, Melatonin",None,,,NKA,"['Palpitations', 'Sleep disorder', 'Tachycardia']",1,PFIZER\BIONTECH,IM 917581,NY,43.0,M,"Hives and urticaria at injection site eight days after dosage, followed by breakouts on other parts of the body.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PVT,Rosuvastatin Aspirin 81mg Melatonin 5mg CoQ10: BabyCoQ10 aspirin 81mg/day Omega-3 w/: Ortho Multi: K2-7 + D3:,,,,,['Injection site urticaria'],1,MODERNA,IM 917582,WA,43.0,F,Arm extremely sore and hard by injection site 3days long All joints stiff and sore-day after Tiredness-day after Nausea(no vomiting)-day after,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,"Multi vit,vit b,fish oil",None,Migraine,,None,"['Arthralgia', 'Fatigue', 'Injection site induration', 'Injection site pain', 'Joint stiffness', 'Nausea']",1,MODERNA,IM 917583,NH,51.0,F,"Woke up day 9 post vaccination with pain, redness and swelling at site of injection , worsened day 10 and 11, today day 12 it?s improving",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/30/2020,8.0,PVT,Bariatric fusion multivitamin,None,Obesity,"At age 50 received shingrix , with second dose had fatigue and body aches",No known allergies,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 917584,VA,29.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Site pain, nausea, fatigue, feeling unwell, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,WRK,"Multivitamin, Zyrtec, Vitamin C, Lexapro",,,,Percocet,"['Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Nausea']",1,PFIZER\BIONTECH,IM 917585,IN,25.0,F,"Moderate muscle aches, fatigue, headache. Swellings did redness at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,UNK,No prescriptions or medications,No illnesses,No known chronic or long standing health conditions,,NKA,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site swelling', 'Myalgia']",2,MODERNA,IM 917586,GA,35.0,F,"Bilateral Lymphadenopathy, Decreased Appetite",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/31/2020,5.0,WRK,"Pre-Natal Vitamin, Famotidine 20 mg, Cetirizine HCI 10mg","Asthma Exacerbation 12/02/2020. COVID Neg x2, Flu Neg. CXR Neg. Resolved with Albuterol Inhaler & Steroid Pack",Asthma and Allergies listed above.,,"NKDA, Allergic to Cats and Dust Mites","['Decreased appetite', 'Lymphadenopathy']",1,MODERNA,IM 917587,OR,52.0,M,"Patient received his vaccine at 1600 and began feeling lightheaded with transient palpitations @ 1615, B/P 154/103 HR 64. 1630 still with lightheadedness B/P 162/106 HR 87 rapid response called. 1700 still lightheaded 175/113 HR 73 O2 99%. Pt. said he still felt dizzy but just wanted to sit for a while longer and did not want to go to ED at that time. 1705 Pt. did end up electing to go to ED because he said he wasn't comfortable going home. Pt. escorted via wheelchair to ED- no further signs of lightheadedness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,PVT,,,,,,"['Blood pressure increased', 'Dizziness', 'Palpitations']",1,MODERNA,IM 917588,IL,26.0,M,"Starting 2-3 days after the day I got the Pfizer vaccine, I had itchiness on my upper chest as well as my neck and upper back. On December, 26th, I looked in a mirror and realized I had red dots on my upper chest, upper back, and neck. Over the next two days (the 27th and 28th) the red dots extended to my stomach, lower back, and shoulders. Up until today, the dots have extended to my upper arms, forearms, hands, and legs. I went to employee health to speak to two nurses who agreed I should report this as a potential allergy to Pfizer's vaccine. I am nervous about taking the second dose but am planning on doing so. I have taken Benadryl and applied hydrocortisone cream on the affected areas. I have a medrol dose pack prescription that I will fill if my symptoms get worse. I do not have trouble breathing, but I am constantly itchy each day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/24/2020,2.0,WRK,,,Hypertension,,,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 917589,PA,29.0,F,"Lightheaded for about 20 minutes post injection. Did not alert staff , waited it out. Onset of lightheadedness was quick .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,mibelas 24 fe,None,None,,NKDA,['Dizziness'],1,PFIZER\BIONTECH,IM 917590,,28.0,F,"Employee reported feeling slight/mild dizziness while sitting car. She stated it's probably from heat in car. she was brought in the clinic, sat down, drank water, and started to feel better. she was observed/monitored for 30 minutes and reported feeling well and no symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,UNK,,,,,,['Dizziness'],UNK,MODERNA,IM 917591,GA,49.0,M,"Shortness of breath, tachycardia, chills, minor muscle aches, nausea, head ache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,OTH,Lipitor 10mg PO QD,none,None,,Penicillin,"['Chills', 'Dyspnoea', 'Headache', 'Myalgia', 'Nausea', 'Oxygen saturation', 'Tachycardia']",1,MODERNA,IM 917592,VA,33.0,F,Headache in afternoon. Chills and severe headache at 2 am (1/1/2021). Severe headache continued and nausea around noon.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,10/31/2020,12/31/2020,61.0,WRK,None,None known,None,,None known,"['Chills', 'Headache', 'Nausea']",1,MODERNA,SYR 917593,MI,79.0,F,"Vomiting, not feeling good, malaise, muscle pain, +fever, vomiting 99-100-99; incr BP 184/79, 136/76, 157/82 feeling better after 24 hours. Given Tylenol. Had refused medications while feeling ill after vaccination, medications taken next day with no problem.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,SEN,"metoprolol tartrate 100mg BID, Lipitor 10 mg daily, sennosides-docusate sodium tablet 8.6/50mg BID, aspirin 81 mg daily, amlodipine besylate 5mg daily, Tylenol prn",none,"cerebrovascular vasospasm and vasoconstriction, arthropathy, TIA, COPD, OA, depression, hypertensive retinopathy, GERD, DM, CKD, HLD, HTN, malignant neoplasm of rectosigmoid junction",,codeine,"['Blood pressure increased', 'Feeling abnormal', 'Malaise', 'Myalgia', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 917594,TN,52.0,F,"12/29/2020 (date of injection) soreness at injection site, Headache & increased Heart Rate. 12/30/2020 Headache, Chills, Body Aches, Fatigue. 12/31/2020 Headache, increased Chills, increased Body Aches, increased Fatigue, feeling Feverish (not able to do ADL's). 1/1/2021 Headache, increased Chills, increased Body Aches, increased Fatigue, feeling Feverish (not able to do ADL's). 1/2/2021 All symptoms are getting better, still slightly there.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,UNK,"Zoloft, Modafinil, Zyzal, Wellbutrin, Vitamin D, Aspirin, Amlodipine, Klonazepam, Latuda, Omeprazole",None,"Interstitial Cystitis, Allergies, High Blood Pressure, Depression",,"Penicillin, Sulfa, Erythromycin, Dicyclomine, Levaquin, Statins, dust, mold, dog, insects, trees","['Chills', 'Fatigue', 'Headache', 'Heart rate increased', 'Injection site pain', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917595,RI,31.0,F,I was about 6 weeks pregnant when I received the vaccine on 12/26/20. I had a miscarriage on 1/1/21. I have a pregnancy history of one prior healthy full term pregnancy in 2019.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/01/2021,6.0,PVT,Pre-natal vitamin,None,None,,None,"['Abortion spontaneous', 'Blood test abnormal', 'Exposure during pregnancy', 'Ultrasound pelvis abnormal']",1,PFIZER\BIONTECH,IM 917596,TN,57.0,F,"Day 1- 1.5 x 1.5cm redness, swollen hard, warm to touch,painful to touch Day- 3x3cm red area, warm to touch, hard center, painful to touch",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PUB,None,None,Back issues. 3 bulging discs,,"PCN, Sulfa, narcotics, erythromycin, seasonal allergies","['Erythema', 'Induration', 'Pain', 'Skin warm', 'Swelling']",1,MODERNA,IM 917597,NH,39.0,F,"About 10 minutes after vaccine, throat became tight feeling, chest tightness, blood pressure 170s/100s, light headed and blurry vision. Ambulance called, brought to the ER administered IV solumedrol, IV Benadryl and monitored for 4 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,"Buspirone 10mg, citalopram 20mg","Light headed, dizzy, headaches","Depression, anxiety",,Tramadol,"['Blood pressure increased', 'Chest discomfort', 'Dizziness', 'Laboratory test', 'Throat tightness', 'Vision blurred']",1,MODERNA,IM 917598,NY,25.0,M,Sharp throbbing pain in the left arm pit. Dull nerve pain shooting down left arm from shoulder to wrist. Pain started the morning after vaccination. Swollen and tender shoulder noted with limited mobility and range of motion. Had no other health condition or disability prior to this.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,None,None,None,,None,"['Axillary pain', 'Joint range of motion decreased', 'Mobility decreased', 'Neuralgia', 'Pain', 'Pain in extremity', 'Pain of skin', 'Skin swelling']",1,PFIZER\BIONTECH,IM 917599,AL,44.0,F,"Injection site reaction. The reaction is an ~4-inch diameter, red, slightly swollen area that is warm to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/31/2020,9.0,PUB,Methimazole,none,Graves' Disease,Injection site reaction to flu vaccine in October 2020.,None,"['Injection site erythema', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 917600,MI,49.0,M,"noted increased BP for 36 hours after vaccine. 162/86, 161/84, 152/79.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,SEN,"acetaminophen prn, trazodone bedtime, methadone 5mg, aspirin 81 mg, hydromorphone 4 mg, ondansetron hcl prn",none,"malignant neoplasm of bladder, CVA, HLD, HTN, tobacco use,",,PCN,['Blood pressure increased'],1,MODERNA,IM 917601,TX,50.0,M,"Pain at injection site for 3 days, on second day had achy joints, poor energy, sweating for about 45 minutes, 3rd day just lack of motivation, poor energy",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/27/2020,1.0,PVT,Metformin atorvastatin lisinoptil nadolol ursodiol Benadryl (otc) melatonin (otc) multivitamin (otc) omeprazope (otc) vitamin d (otc) symbicort inhaler venlafaxine insulin,Diabetes type 2 insulin dependent,Diabetes type 2 insuline dependent,,Bactrim,"['Apathy', 'Arthralgia', 'Asthenia', 'Injection site pain']",1,MODERNA,SYR 917602,KS,26.0,F,"Injection site pain began about 5 hours after getting vaccine and progressively worsened. Unable to lift arm above shoulder without significant pain at about 12 hours post injection. About 13-14 hours post vaccine, began having myalgias, chills. Took ibuprofen with some improvement of symptoms, but unable to sleep due to the combination of arm pain, chills and aches. Body aches and chills were gone by the morning but the arm pain lingered, less than the night before and improving each day, still there today, but much more tolerable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Novolog insulin, Liletta IUD",None,Type 1 diabetes,"Influenza- body aches in past, usually occurs every time I get it.",PCN,"['Chills', 'Injection site pain', 'Mobility decreased', 'Myalgia', 'Pain', 'Pain in extremity', 'Sleep disorder']",1,MODERNA,IM 917603,CA,39.0,F,Vasovagal symptoms developed about 5 min after receiving vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,None,None,None,,Nkda,"['Electrocardiogram', 'Presyncope']",1,MODERNA,IM 917604,,66.0,F,"PVCs about 45 minutes after injection. Although I have had them before, it?s been at least a month since they have occurred. They don?t usually happen in the morning without any activity. Also felt a bit weak later in the day but not sure this was from vaccine. I was fine the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,"Eliquis. Levothyroxine , Prilosec, metoprolol, aspirin, Vit D",,Atrial Fibrillation,,Penicillin,"['Asthenia', 'Condition aggravated', 'Ventricular extrasystoles']",UNK,MODERNA, 917605,FL,52.0,F,"At 9:59AM (9 minutes after vaccination) I suddenly felt dizzy and like I was going to pass out. My body was tingling from head to toe. My chest felt heavy but I think that may have been slight anxiety because it was a scary feeling and I did not want to be the person who needed EMS assistance. I rolled down my window, took off my mask and took deep breaths of fresh air. I slowly started to feel better. At 30 minutes I felt much better and after an hour I was back to my normal self.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,UNK,"Synthroid, Folic Acid, Vitamin D",None,Hypothyroidism,,None,"['Anxiety', 'Chest discomfort', 'Dizziness', 'Hypothyroidism', 'Paraesthesia']",1,MODERNA,SYR 917606,CA,48.0,M,"Head ache first day with weakness and chills. Next day I went to work and since I can?t put weight on, trouble sleeping, minimal appetite, I have a hoarse voice and it starts to go out.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/28/2020,1.0,OTH,Ramipril 5mg Rosuvastatin 5mg Men?s multivitamin,COVID-19,High blood pressure High cholesterol,,None,"['Asthenia', 'Chills', 'Dysphonia', 'Headache']",UNK,MODERNA, 917607,WA,44.0,F,"Woke up next day very fatigued, left work after 1/2 day and slept 20hrs Two days after injection lymph nodes very sore and swollen in armpit (pain with applying deodorant) Four days after injection bruising with about 3x3 cm area of redness/swelling present at injection site Daily headaches managed with ibuprofen Not anything too concerning but not comfortable. I have never reacted to a vaccine prior",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,WRK,Birth control Albuterol prn Advil prn,,"Asthma, well contolled",,Alieve,"['Axillary pain', 'Discomfort', 'Fatigue', 'Headache', 'Impaired work ability', 'Injection site bruising', 'Injection site erythema', 'Injection site swelling', 'Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 917608,CO,43.0,F,Red around injection site. Has not gone away.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,PVT,Alive multivitamin Probiotics Thyroid supplement Cosamin Ds,None,None,,None,['Injection site erythema'],1,MODERNA,SYR 917609,HI,56.0,F,"advised to wait 30 min post shot for monitoring d/t latex allergy. completed without s/s. returned approx 20 min c/o itching to arm at injection site, stated, throat had been internally itchy for about 10 min after leaving vaccination area but that passed on its own. advised to use cold compress on arm and monitor self. let vaccination center without questions, concerns.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,PVT,NO,NO,,,"fragrance, latex, nickel, perfumes","['Injection site pruritus', 'Throat irritation']",1,PFIZER\BIONTECH,IM 917610,CO,32.0,F,"Reported at 6:29 sat on toilet with right arm pain of 7-8 out of 10. Reached for her cell phone on sink and had a syncopal episode 1 day post vaccine. reports history of vasovagal and hyperglycemia. A provider she works with was called and she was given juice, crackers, and two Advil. Pain resolved, no other symptoms reported. Is being followed up by her PCP for workup. No other syncopal episodes reported therafeter.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,unknown,None,unknown,,NKDA,"['Pain in extremity', 'Syncope']",1,PFIZER\BIONTECH,IM 917611,,31.0,F,"12 hours - swollen and sore arm 24-36 hours - fever up to 103.4, chills, sweats",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,Vitamin D Ibuprofen,Orthopedic surgery two weeks prior,,,Clindamycin Sulfa,"['Chills', 'Hyperhidrosis', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 917612,HI,47.0,F,"rec'd shot 1405, monitored for 30 min d/t flu vaccine allergy in past as recommended by physician on call. 35 min in c/o itching to face and neck. monitored for 15 more min, declined cold compress, advised to monitor symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,PVT,HCTZ nexplanon restasis,NO,"htn, dyspnea",,flu vaccine,['Pruritus'],1,PFIZER\BIONTECH,IM 917613,AK,31.0,F,"Fatigue, chills, pain at injection site radiating down left arm. Took Advil as needed and Benadryl after 24 hours of unresolved symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Breo, singulair, adderall, Zyrtec, vitamin d, hair skin and nails vitamin",None,"Asthma, adhd",Tetanus,No,"['Chills', 'Fatigue', 'Injection site pain', 'Pain']",1,MODERNA,SYR 917614,TX,26.0,F,"Moderna COVID-19 Vaccine EUA Lots of pain and soreness in vaccination site. Low fever(99.9F), chills, body ache, joint paint started 01/02/2021 at 4:30pm Treatment: slept and took 2 Tylenol?s. Outcome: fever down to 99.2 an hour later, body still aching",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/01/2021,01/02/2021,1.0,PVT,,,,,,"['Arthralgia', 'Chills', 'Pain', 'Pyrexia', 'Vaccination site pain']",1,MODERNA,SYR 917615,IN,42.0,F,"I had chills, headache, and was nauseous all day but around 630 I passed out and smacked my face when getting out of the shower.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,UNK,Lexapro,None,None,,None,"['Chills', 'Face injury', 'Headache', 'Loss of consciousness', 'Nausea']",1,MODERNA,SYR 917616,CA,58.0,M,"Injection site pain and tiredeness day after injection. Severe left sided low back pain centered in sacroiliac joint, next day radiating into left leg and left thorax on Sunday, five days after injection. Severe disruption in all ADLs necessitating narcotic pain medication and an emergent visit with chiropracter. This pain is somewhat better but still persists today 14 days after onset!! This is absolutely miserable. I think I'd rather have COVID",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/15/2020,12/20/2020,5.0,OTH,"Garden of life mens 50 plus multivitamin daily Zinc 100 mg daily Vital reds one scoop daily Vit D 10,000 units daily pregnenolone 30 mg daily DHEA 15 mg daily Iodine 15 mg daily",None- I'm in excellent health,None,,tomatoes,"['Arthralgia', 'Back pain', 'Chest pain', 'Fatigue', 'Feeling abnormal', 'Injection site pain', 'Loss of personal independence in daily activities', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 917617,MO,38.0,F,I broke out in a face rash. It started at my chin and went up my jaw lines. Was dry and itchy. No lotion or creams I tried work. It finally went away on its own in about a week.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/21/2020,4.0,PVT,,,,,Cats,"['Rash', 'Rash pruritic']",1,PFIZER\BIONTECH,SYR 917618,PA,60.0,F,"Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling hot/cold",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,Pantoprazole Multi vitamin,None,None,,"Amoxicillin, Augmentin, crab","['Dizziness', 'Dry mouth', 'Dysphagia', 'Feeling of body temperature change', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pharyngeal swelling', 'Tremor']",1,PFIZER\BIONTECH,IM 917619,OH,36.0,F,Fever of 99.5 overnight after vaccination. Fatigue starting about 11 hours after injection and lasting the entire day after that.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,Strattera,None,None,,None,"['Fatigue', 'Pyrexia']",UNK,MODERNA, 917620,TX,29.0,F,25 hours post vaccine I had a hive on my lip that started swelling up and what felt like an itchy throat. I took a benedryl and then after about an hour it subsided. I had not had anything but but usually coffee this morning prior to that reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/02/2021,1.0,PVT,Synthroid daily Multivitamin daily,None,Hypothyroidism d/t removed thyroid cancer in 2019,,Allergic to sulfa drugs Environmental allergies,"['Lip swelling', 'Throat irritation', 'Urticaria']",1,MODERNA,SYR 917621,IL,22.0,M,"Left side of body, extremities are feeling numb and tingly.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PUB,Possibly benadryl,N/a,Asthma,,"Nuts, avocados, dust","['Hypoaesthesia', 'Paraesthesia']",1,MODERNA,SYR 917622,KY,54.0,F,I developed large blister like lesion inside of my Mouth 2.5 hours after the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,PVT,"Metformin , lisinopril, fenofibrate, ozempic",None,"HTN, Type 2 DM, high triglycerides",,Penicillin,['Oral mucosal blistering'],1,MODERNA,IM 917623,NY,57.0,F,the patient discovered rash on the entire body almost 12 hours after Moderna COVID-19 rash. Not sure when the rash started but was discovered almost 12 hours later.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,['Rash'],1,MODERNA,IM 917915,NC,,F,"Patient had a flu shot on 10/6/20 then started weekly Kanjinti/Taxol for her HER2+ metastatic pancreatic cancer on 10/16/20. She had a slight cough after her flu shot. Following C1D1 Kanjinti/Taxol on 10/16/20, her cough, which developed in to shortness of breath, progressively worsened. Symptoms continued to worsen through the next two cycles to the point where she was barely able to walk from her bed to the bathroom. She had a chest x-ray on 10/30/20 which showed pulmonary infiltrates in a reticulonodular pattern consistent with a drug reaction or progression. She was started on 40 mg prednisone daily on 11/13/20 but symptoms did not improve significantly prompting hospitalization for supportive care on 11/20/20.",Not Reported,,Not Reported,Yes,,Not Reported,,,11/13/2020,,UNK,Kanjinti; Taxol,Patient with metastatic pancreatic cancer.,,,,"['Chemotherapy', 'Chest X-ray abnormal', 'Cough', 'Dyspnoea', 'Gait disturbance', 'Lung infiltration', 'Supportive care']",UNK,UNKNOWN MANUFACTURER, 917918,WA,32.0,F,"Hep B vaccine has caused my face to droop, facial parasthesia, migraine, nerve pain in my left leg, muscle spasms, twitching. It has had me have to have an MRI of my brain, numerous doctors visits, loss of grades in school due to not being able to concentrate. Neuro appointment has classified my nervous system issues from adverse reaction to the hep b vaccine.",Not Reported,,Not Reported,Not Reported,,Yes,,,11/18/2020,,UNK,,,,,,"['Adverse reaction', 'Blood test', 'Facial paralysis', 'Laboratory test normal', 'Magnetic resonance imaging brain normal', 'Migraine', 'Muscle spasms', 'Muscle twitching', 'Neuralgia', 'Paraesthesia']",UNK,UNKNOWN MANUFACTURER,IM 918693,AK,60.0,F,"Starting at 0100 am I noticed chills, body aches, vomited, then felt crappy all day. Thursday night 12/31 symptoms worsened with above & headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,WRK,,none,none,,"morphine, demerol","['Chills', 'Headache', 'Malaise', 'Pain', 'Vomiting']",1,PFIZER\BIONTECH,IM 918709,TX,20.0,M,"Intense arm discomfort/pain and injection site soreness, began around 2 to 3 hours after innoculation, lasted around 36 hours. Severe uncomfortable incessant shivering began at 21:00 12/30 and persisted for an hour. Intense cold sweats began at 20:30 12/30 and lasted around 18 hours, this symptom was also accompanied by a fever with a peak of 101.7� that lasted a similar duration. Unpleasant yet bearable body aches manifested the morning of 12/31 around 08:00 and did not subside until the next day. Throbbing, sharp headache began 12/30 at 13:00 and persisted until 12/31 around 19:00. 325mg of enteric coated aspirin was taken on three different occasions, 12/30 at 21:30, 12/31 at 08:30, and 1/1 at 00:30. 1,000mg of acetaminophen was also ingested on 1/1 at 00:30. All symptoms dispersed by noon of 1/1 and have not reoccurred.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"Venlafaxine ER 150mg, Guanfacine ER 4mg, Montelukast 10mg, Omega 3, Multivitamin, acetylcholine",None,Asthma,,Peanuts,"['Chills', 'Cold sweat', 'Injection site pain', 'Pain', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 antibody test positive']",1,MODERNA,IM 918771,NY,,M,Severe reaction to influenza vaccine (FLU *20-21 FLUZONE HD) Lot UJ512AB. Administered 10/26/2020. Five hours after receiving the vaccine sudden onset of very high fever (up to 103.6) and violent shivers. Fever still high after 24 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,,10/26/2020,10/26/2020,0.0,UNK,"Synthroid 175 mcg, Tamsulosin 0.4 mg, Fosamax",,None,,None,"['Chills', 'Pyrexia', 'Vaccination complication']",UNK,SANOFI PASTEUR,IM 918831,,,F,vaccine reaction,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/16/2020,12/16/2020,0.0,UNK,,,,,,['Vaccination complication'],UNK,PFIZER\BIONTECH, 918913,CA,,F,"I had the PNEUMOVAX 23 vaccine administered to me despite the fact that it is recommended for ages <2 or >50. I now suffer extreme pain and debilitating results, including severe trauma. The following are listed symptoms of the said vaccination: a decreased appetite a slightly raised temperature irritability redness and swelling at the site of the injection feeling sleepy or not sleeping well Serious side effects of the PCV vaccine are rare, and include: a high temperature, possibly leading to convulsions (febrile seizures) allergic reactions, such as an itchy skin rash. I have experienced all of these symptoms to a severe degree since having the vaccination administered to me against my own knowledge. I have never had pneumococcal disease so why this vaccine shows in my health records as administered to me is yet another example of how I have been the victim of EXTREME MALPRACTICE. I expect that this will be reviewed and corrected, along with ALL OTHER VACCINES BEING ADMINISTERED TO THE HUMAN BEINGS THAT MAKE UP OUR COUNTRY AND UNITED NATIONS. THIS IS AN EXTREME ABUSE OF POWER AND OBVIOUS DISCRIMINATION AS WELL AS AN ATTEMPT TO MASS GENOCIDE MINORITIES.",Not Reported,,Yes,Not Reported,,Yes,,,,,UNK,Acetaminophen; Magnesium Odor-free Garlic Vitamin C Multivitamin Health and beauty vitamin Vitamin D3 Vitamin E Vitamin B12 Kava kava,,1 glass of wine every now and then; Iron Deficiency Without Anemia Vitamin D Deficiency Congenital Pes Planus Atopic Dermatitis Dysmenorrhea Ankle Joint Pain Low Back Pain Idiopathic Peripheral Neuropathy Fibromyalgia Major Depressive Disorder Anxiety Disorder PTSD Learning Disabilities (dyslexia/ ADHD/ High-functioning Autism),,"Eurythromyacin, Prozac","['Decreased appetite', 'Febrile convulsion', 'Hypersensitivity', 'Injection site erythema', 'Injection site swelling', 'Injury', 'Irritability', 'Pain', 'Poor quality sleep', 'Pyrexia', 'Rash pruritic', 'Somnolence']",UNK,MERCK & CO. INC.,SYR 918944,PA,65.0,M,"I received a flu shot (High Dose for those over 65) on 10/29/2020 at my primary care physicians office. 24 hours following the injection my fasting blood sugar was unusually high at 153. I monitored more closely over the next 48 hrs. On Saturday, 10/31, my blood sugar rose to over 300 mg/dl. I took my blood sugar every two hours until Sunday morning 11/1 when it returned to 117 and stabilized. I'm concerned that I was not warned of this possible side effect and what to do if it happened.",Not Reported,,Not Reported,Not Reported,,Yes,,10/29/2020,10/31/2020,2.0,UNK,"Metformin, Onglyza, Rosovustatin, Fluoxitene, Blood Glucose Monitoring",Moderate Alcohol Use,"Type 2 Diabetes, High Cholesterol",,None,['Blood glucose increased'],UNK,SANOFI PASTEUR,SC 918947,VT,50.0,M,"Received a pneumovax23 shot mid to high RH deltoid at a pharmacy with both people seated. 16hrs later, severe pain limits the ability to lift RH arm above the shoulder. Accompanied by Fever (99.5-101.5) unresponsive to 500mg Tylenol.",Not Reported,,Not Reported,Not Reported,,Yes,,10/30/2020,10/30/2020,0.0,UNK,Aspirin Zubeta Lanzoprazole Famotadine Dulera Citirizine Vitamin D3 Vitamin B complex,,Asthma CVD,,Amoxicillin,"['Mobility decreased', 'Pain', 'Pyrexia', 'Vaccination site movement impairment']",UNK,MERCK & CO. INC., 918948,FL,,F,Patient was hospitalized for reaction on 10/25/2020-10/27/2020,Not Reported,,Not Reported,Not Reported,,Not Reported,,10/01/2020,10/08/2020,7.0,UNK,,,,,,['Nonspecific reaction'],UNK,GLAXOSMITHKLINE BIOLOGICALS,IM 918954,OH,74.0,M,"On 2/1/2020 I received my second shingrix shot. I was advised (as usual) that I would experience stiffness/soreness. However, within 24 hours I had sore throat and dry cough. On 2/2.2020 I began experiencing pain and stiffness in all muscles and joints which continued to get worse each day. On 2/21/2020 I went to my PCP since I could not raise my arms to shoulder height and had difficulty walking. I was put on a 12 day prednisone (40-30-20-10 mg) regimen. The pain was alleviated until the 10 mg does at which the pain and stiffness returned. On 3/12/2020 the PCP put me on a second course of prednisone (again 40-30-20-10 mg) and advised if it to worse I should see a rumatologist. I inquired if it could be Covid and should I be tested to which he said no. On 3/23/2020 I began experiencing a pronounced shortness of breath with rapid heart rate with minimal exertion (resting HR of 85 to exertion rate of 155-165). This concerned me since I am very active (having spend an average of 55 minutes a day exercise for 234 continuous days working out on various combination s of exercises on a treadmill, recumbent bike, rowing machine, soloflex, weights, and back exercises suggested for a bad back). When the shortness of breath made it difficult to exercise and having a third course of prednisone, I saw a rumitologist who advised I get heart tests and pulmonary function tests. He also kept me on a progressively reduced prednisone level to address polymyalgia rheumatica -- varying several times as symptoms would increase and decrease. In July, I did go for EKG, echocardiogram, chemical stress, and an imaging test -- which showed no problems with the heart. I again asked if this could be Covid, to which the heart Dr asked for an antibody test, which came up negative. Considering the length of time from initial symptoms and the potential for false testing along with the persistence of antibodies with extended time I accepted the results. i have also gone to a pulmonary physician and had x-rays, breathing tests, a 'sniff' test to fluoscopically scan lung function and in addition had sleep studies. Only thing determined was possible sleep apnea -- which I question since I get 8-9 hours sleep and am not napping the next day. Also, my wife says I do not stir at night. To date, I have maybe recovered about 10-20% of the breathing I lost and the heart rate is still high with minimal exertion. I can work out on the bike for limited time. My research on the internet led me determine that possibly the shingrix 'deactivated' virus caused a polymyalgia rheumatica response. As the prednisone was increased and extended over a long period of time literature shows that some people have a shortness of breath and increased heartrate response to the drug. Several of the doctors have doubted my analysis and said the symptoms were chance occurrences. As an R&D scientist/engineer in industry, I have learned there are essentially no coincidences in life or test results. I now still believe I had a reaction to the shingrix with a resultant response to the treatment with prednisone. Likewise, I have considered that I potentially had Covid and with early treatment with prednisone steroid I may have been put into a long haul status. To date, I have not been tested for Covid, and would wonder if residual virus could be detected in long haul persons. In any case, my life has been seriously affected with several thousands of dollars of testing saying I am healthy yet have these symptoms continuing. At my current prednisone reduction schedule, I should be off prednisone in July 2021. Even with reduced prednisone dosage changes, I've seen only marginal improvement in breathing/heart rate. When this began I was 73 years old and in my opinion I was physically in the mid 30 to mid 40's due to my exercise regimen. Rheumatologist diagnosed polymyalgia rheumatica based on CRP and sed rate.",Not Reported,,Not Reported,Not Reported,,Yes,,,02/01/2020,,UNK,"Sertraline for SAD 100mg (Zoloft) 1/day during winter; 50mg during summer @ breakfast Losartan (Cozaar) 100mg, 1/day for high BP @ bedtime Levothyroxin 112mcg (Synthroid) 1/day hypo thyroid after irradiated for Graves' @ at least. 1/2 hr b",,"prediabetic, graves disease, high blood pressure",,"penecillin, latex","['Arthralgia', 'C-reactive protein', 'Cardiac imaging procedure normal', 'Cardiac stress test normal', 'Cough', 'Dyspnoea', 'Echocardiogram normal', 'Electrocardiogram normal', 'Gait disturbance', 'Heart rate increased', 'Joint range of motion decreased', 'Joint stiffness', 'Musculoskeletal stiffness', 'Myalgia', 'Oropharyngeal pain', 'Polymyalgia rheumatica', 'Pulmonary function test', 'Red blood cell sedimentation rate', 'SARS-CoV-2 antibody test negative', 'Sleep study', 'X-ray']",2,GLAXOSMITHKLINE BIOLOGICALS,SYR 920333,CA,,F,"Received flu vaccine, egg and preservative free, Flucelvax. By the time I got home I had difficulty breathing/anaphylactic shock, wheezing, dizziness, red and hard injection site, fever. I had an injection pen due to severe food allergies and used it. My heart was racing. I continued to take benedryl for days when symptoms returned.",Not Reported,,Yes,Not Reported,,Not Reported,,11/08/2018,11/08/2018,0.0,UNK,None; None,,,,"Penicillin, Macrobid, sulfa, mold, dust mites, dairy, egg, ragweed.","['Anaphylactic shock', 'Dizziness', 'Dyspnoea', 'Injection site erythema', 'Injection site induration', 'Palpitations', 'Pyrexia', 'Wheezing']",UNK,NOVARTIS VACCINES AND DIAGNOSTICS, 920349,TN,,F,"Pfizer EUA vaccine 30mcg/0.3ml Patient received the vaccination on Tuesday 12/22/2020 waited the 15 minutes post vaccination to ensure no side effects and was asymptomatic post vaccination. Twenty-four hours later, patient called to report that she was experiencing noted tachycardia with rates of 125 bpm, redness on her chest, and chest tightness. She reports not issues with shortness of breath nor labored breathing.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/23/2020,1.0,UNK,,,NKDA,,,"['Chest discomfort', 'Erythema', 'Tachycardia']",UNK,PFIZER\BIONTECH,IM 920351,,76.0,F,"After receiving the flucelvax patient had very severe allergic reaction. Arm went numb and to her legs and neck, trouble breathing went to the hospital. After one month patient is still suffering.",Not Reported,,Not Reported,Yes,,Not Reported,,10/09/2020,10/09/2020,0.0,UNK,,,,,,"['Dyspnoea', 'Hypersensitivity', 'Hypoaesthesia']",UNK,"SEQIRUS, INC.",SYR 920376,,,F,Reaction to Pfizer covid 19 vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,,,12/19/2020,,UNK,,,,,,['Vaccination complication'],UNK,PFIZER\BIONTECH,IM 920403,VA,1.0,U,Pzifer COVID 19 vaccine vial had white speck floater after dilution with NS 1.8 ml. Saw upon inspection and zero doses were utilized from this vial.,Not Reported,,Not Reported,Not Reported,,Not Reported,,,12/18/2020,,UNK,,,,,,"['Intercepted product dispensing error', 'Liquid product physical issue']",UNK,PFIZER\BIONTECH, 920466,VA,,F,"Took 2nd Shingritz injection on 11/20/20. Two days later had MAJOR outbreak of HSV2, after several years symptom/outbreak free. (Had ceased having outbreaks after Zostervac vaccine.) This is worst outbreak since initial one more than 40 years ago. Anecdotally, it appears that many others have had this occur. Thought you would want to know.",Not Reported,,Not Reported,Not Reported,,Yes,,11/20/2020,11/22/2020,2.0,UNK,"levothyroxine 100 mcg, Oncovite, Tums, Biotin, melatonin",,"hypothyroidism, HSV2",,"sulfa, penicilin","['Condition aggravated', 'Herpes simplex']",UNK,GLAXOSMITHKLINE BIOLOGICALS,IM 920468,,61.0,F,"Received shingrix 12/4/2020. Developed exercise intolerance, palpitations, dyspnea afterwards. Exercised w/o problems until 12/4/20. Symptoms got progressively worse. EKG on 12/21 /20 showed SVT vs a fib at 172 bpm. Sent to the ER. Spent 2 nights in the hospital. Echo showed severe MR. New onset a fib. Echo in 09/2020 showed mild - mod MR. Symptom onset coincided with vaccine administrtaion",Not Reported,,Yes,Yes,,Not Reported,,12/04/2020,12/21/2020,17.0,UNK,,,mitral regurg,,,"['Atrial fibrillation', 'Dyspnoea', 'Dyspnoea exertional', 'Echocardiogram abnormal', 'Electrocardiogram abnormal', 'Exercise tolerance decreased', 'Mitral valve incompetence', 'Palpitations']",UNK,GLAXOSMITHKLINE BIOLOGICALS, 920469,TX,39.0,M,"COVID-19 vaccine under Emergency Use Authorization. Healthcare professional received Pfizer-Biontech COVID vaccine, Lot EK5730, on 12/16/20. Developed high grade fever for 1 day followed by significant muscle aches, headache, palpitations, nausea, and fatigue. Missed work for 4 days and went to ER on day 3. Still had some symptoms at time of report on 12/20/20.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/16/2020,12/16/2020,0.0,UNK,,,,,,"['Fatigue', 'Headache', 'Impaired work ability', 'Myalgia', 'Nausea', 'Palpitations', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 920471,CA,34.0,F,"Received the Pfizer COVID-2019 vaccine and within 5 minutes developed tingling and felt like pins and needles in the ring finger and hand of the arm injected (right arm). Started to improve about half an hour later, completely resolved within 2 hours. I was evaluated by our employee health services NP and my HR was slightly elevated but no other concerning symptoms noted.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/18/2020,0.0,UNK,,,PCOS; Allergies to ALEVE,,,"['Heart rate increased', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 920476,TX,39.0,M,"COVID-19 vaccine under Emergency Use Authorization. Healthcare professional received Pfizer-Biontech COVID vaccine, lot EK5730, on 12/16/20. Developed high grade fever for 1 day followed by significant muscle aches, headache, palpitations, nausea, and fatigue. Missed work for 4 days and went to ER on day 3. Still had some symptoms at time of report on 12/20/20.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/16/2020,12/16/2020,0.0,UNK,,,,,,"['Fatigue', 'Headache', 'Impaired work ability', 'Myalgia', 'Nausea', 'Palpitations', 'Pyrexia']",1,PFIZER\BIONTECH,IM 920485,MI,62.0,M,"Received the shingles vaccine Shingrix on 12/1/2020 Woke up morning of 12/15 with a whooshing sound in his ears and a significant decrease in hearing bilaterally . The ""whooshing"" has stopped, but the hearing loss has remained .",Not Reported,,Not Reported,Not Reported,,Yes,,12/01/2020,12/15/2020,14.0,UNK,Allopurinal 100 mg daily,,Gout,,Keflex,"['Hypoacusis', 'Tinnitus']",UNK,GLAXOSMITHKLINE BIOLOGICALS,SC 920500,MI,86.0,M,"Patient reports he had a reaction to the flu shot. Nausea, vomiting, and confusion.",Not Reported,,Not Reported,Yes,,Not Reported,,,10/19/2020,,UNK,abiraterone acetate; prednisone; casodex; metformin; lantus; Symbicort; zetia; ipratropium; isosorbide; omeprazole,,"malignant neoplasm of prostate. Allergy to triamterene, amlodipine, amoxicillin, atorvastatin, cephalexin, ciprofloxacin, clarithromycin, levofloxacin, losartan, sulfadiazine.",,,"['Confusional state', 'Nausea', 'Vomiting']",UNK,UNKNOWN MANUFACTURER,SYR 920620,MI,,M,"After being administered the Shingrix shot, coughing started 4 hours later. Coughing lasted 3 hours. This led to vomiting. Vomiting continued for 10 continuous hours. Admitted to ED for extreme dehydration due to vomiting. 2+ liters of fluid administered. along with medication to settle the stomach and medication for pain. 5 hour hospital ED visit.",Not Reported,,Not Reported,Yes,,Not Reported,,09/23/2020,09/24/2020,1.0,UNK,Cortisone cream as needed for dry skin,none,none,,NKA,"['Cough', 'Dehydration', 'Pain', 'Vomiting']",UNK,GLAXOSMITHKLINE BIOLOGICALS,IM 920622,AL,53.0,F,"MODERNA VACCINE-received vaccine and immediately felt hot, fanning with papers, vitals: BP normal , HR 105, complaining of feeling hot and throat feeling tight. Given 25 mg Benadryl liquid, took to ED, second dose of Benadryl given, discharged",Not Reported,,Not Reported,Not Reported,,Not Reported,,,12/29/2020,,UNK,,,,,,"['Feeling hot', 'Immediate post-injection reaction', 'Throat tightness']",UNK,MODERNA,IM 920665,LA,39.0,F,"Covid Pfizer vaccine dose one on 12/21/20 - at 18 minutes post vaccination, globus sensation, diaphoresis, neuropathic crawling all over scalp, loss of consciousness, heart rate 35 bradycardia event. Responders said I was out for a minute or so then regained consciousness. Pupil dilation during event per responders. ICU MD responder states no radial pulse but had carotid pulse which was weak at initial loss of consciousness. Given fluids. Blood pressure normal during fluids. Improved heart rate without tachycardia. Had recurrence of clammy hands, globus sensation with frequent swallowing/throat clearing about 30 minutes after initial event while still receiving fluids. No airway compromise or stridor. Received PO Benadryl 25 mg. Transferred to ER for monitoring for an additional 90 minutes with complete resolution of globus sensation about 30 minutes after Benadryl. Fatigue and weak post event.",Not Reported,,Not Reported,Not Reported,,Not Reported,,,12/21/2020,,UNK,"paraguard IUD, nasonex",none,none,,none,"['Asthenia', 'Bradycardia', 'Carotid pulse abnormal', 'Cold sweat', 'Dysphagia', 'Fatigue', 'Formication', 'Full blood count normal', 'Hyperhidrosis', 'Loss of consciousness', 'Metabolic function test normal', 'Mydriasis', 'Radial pulse abnormal', 'Sensation of foreign body', 'Throat clearing']",UNK,PFIZER\BIONTECH, 920751,AL,,F,Moderna Vaccine- employee had fever of 102 next day and could not come to work,Not Reported,,Not Reported,Not Reported,,Not Reported,,,12/29/2020,,UNK,,,,,,"['Impaired work ability', 'Pyrexia']",UNK,MODERNA,IM 920752,TX,53.0,F,"I got my flu shot on November 5, 2020. FLUZONE QUAD 2020-2021 VIAL SUSPENSION I have been sick since the day after, feels like a head cold. I am so tired my nose is stuffy then I get headaches. I can seem to have enough energy to get through the day. I got tested for Covid and tested negative. Will this feeling go away or do I have to see a doctor? Please advice do I need to go see a doctor?",Not Reported,,Not Reported,Not Reported,,Yes,,11/05/2020,11/05/2020,0.0,UNK,"Lisinopril 10mg, D3 5000units 1xday",,Hbp,,N/a,"['Asthenia', 'Fatigue', 'Headache', 'Malaise', 'Nasal congestion', 'Nasopharyngitis', 'SARS-CoV-2 test negative']",UNK,SANOFI PASTEUR,IM 920844,PA,64.0,F,"Healthy 64 year old received her initial dose of shingrix vaccine on 11/06/2020 in our primary care office. 1 week later, she began to feel symptoms of fatigue and brain fog. 1 week after onset of symptoms, she developed aphasia and hemiparesis of her right side. She was hospitalized and after a detailed work up, was diagnosed with a viral meningitis, determined to be likely a zoster meningitis, and developed a rash the following week. She is now on IV medication daily acyclovir and rocephin by PICC and following with infectious disease and only ongoing symptom is fatigue.",Not Reported,,Not Reported,Yes,,Not Reported,,11/06/2020,11/13/2020,7.0,UNK,,,"Pmhx included hypertension, hyperlipidemia, and benign thyroid nodules. NKDA. No history of previous vaccine reactions. No tobacco use history.",,,"['Aphasia', 'Fatigue', 'Feeling abnormal', 'Hemiparesis', 'Herpes zoster meningitis', 'Meningitis viral', 'Rash']",UNK,GLAXOSMITHKLINE BIOLOGICALS,IM 921188,WI,22.0,M,"22 year old patient with no known allergies or medical history admitted 12/21 with TTP and currently being worked up. Currently unclear if related or unrelated to COVID vaccination, but received Pfizer vaccine Thursday 12/17.",Not Reported,,Not Reported,Yes,,Not Reported,,12/17/2020,12/21/2020,4.0,UNK,,None known,,,,"['Platelet count decreased', 'Thrombotic thrombocytopenic purpura']",UNK,PFIZER\BIONTECH, 921190,GA,,U,"During a Covid-19 Vaccination Clinic for employees, a mixing error occurred with 3 Covid-19 vaccine vials. Nursing mixed and used 3 vials on 10 patients. Proper procedure requires 1.8 mL of Normal Saline 0.9% be added to 1 Pfizer-BioNTech COVID-19 vaccine vial. This quantity (3 vials) should have been enough for 15 patients. Facility pharmacist was called to investigate and found syringes that were used for dilution still had liquid in the syringe. It is believed that nurse mixing vials pressurized contents with backflow into syringe without realizing this had occurred. Volume injected into patient was accurate with double check of 0.3 mL. We are unable to verify proper mixing of vaccine vials was accomplished. All 10 patients are being notified of the potential error.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/16/2020,,,UNK,,,,,,['Product preparation issue'],UNK,PFIZER\BIONTECH, 921196,CO,67.0,F,Right 6th cranial nerve palsy was noted 9 days after the 2nd Shingrix vaccine injection. A clinical exam by an ophthalmologist diagnosed the issue.,Not Reported,,Not Reported,Not Reported,,Yes,,10/26/2020,11/04/2020,9.0,UNK,"Hydrocortisone 20mg QD, Thyroid Levothyroxine: 88mcg",,Adrenal insufficiency,,NKDA,"['Ophthalmological examination abnormal', 'VIth nerve paralysis']",UNK,GLAXOSMITHKLINE BIOLOGICALS,SC 921199,,59.0,F,I received the Pfizer COVID-19 vaccine at six 17:06. Starting at - 18:00 and for the subsequent 24 hours I felt soreness at a level of 2-3/10 at the injection site. Starting at - 19:00 the pain radiated down toward my elbow and up into my neck and base of skull. The soreness in my neck and base of skull was at a lever of 4/10. By 12/24/20 at approximately 18:00 the side effects had dissipated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/23/2020,0.0,UNK,"Rosuvastatin 10mg qhs Aspirin 81 mg qhs Multivitamin, fish oil 1000mg, calcium-magnesium-zinc 133 mg-33mg-5mcg folic acid",,Hypercholesterolemia,,Sulfa,"['Headache', 'Injection site pain', 'Neck pain', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH,SC 921201,NC,65.0,F,"Received Previnar13. Muscle weakness, pain, shoulder very painful joint with limited range of motion. Ongoing since initial injection. Now getting physical therapy.",Not Reported,,Not Reported,Not Reported,,Yes,,11/08/2019,11/08/2019,0.0,UNK,,,,,"Sulfa, iodine","['Arthralgia', 'Muscular weakness', 'Pain']",UNK,PFIZER\WYETH,IM 921204,NY,58.0,F,"Pt received the Moderna Covid vaccine, after the injection pts fingers hands and lips when numb. Pt is now okay reaction did not last long",Not Reported,,Not Reported,Not Reported,,Not Reported,,,12/28/2020,,UNK,,,,,,"['Hypoaesthesia', 'Hypoaesthesia oral']",UNK,MODERNA, 921206,AL,41.0,F,"Moderna Vaccine- patient had allergic reaction- 12 minutes later from receiving vaccine, began to feeling hot and started fanning, denied any SOB, no wheezing noted. B/P 142/83 HR 105. Benadryl liquid 25 mg given. Enroute to ED employee became nauseated and gaging. HR 113 at ED, coughing more, was treated in ED with Solumedrol and Pepcid prior to discharge",Not Reported,,Not Reported,Not Reported,,Not Reported,,,12/29/2020,,UNK,,,,,,"['Cough', 'Feeling hot', 'Hypersensitivity', 'Nausea', 'Retching']",UNK,MODERNA,IM 921207,OH,,U,RN experienced in COVID-19 vaccinations unable to remove final full 0.5mL dose from vial - about 0.1mL short,Not Reported,,Not Reported,Not Reported,,Not Reported,,,12/30/2020,,UNK,,,,,,['Product preparation issue'],UNK,MODERNA,IM 921210,TX,65.0,F,Had my first Shingrix vaccination on Oct 29 2019 GSK Lot number 3099 Also had Prevnar 13 Pfizer Lot AP2987 same day Developed shingles diagnosed by my doctor on Nov 5 2019 Treating with valacyclovir 1 gram TID for 7 days.,Not Reported,,Not Reported,Not Reported,,Yes,,10/29/2019,11/05/2019,7.0,UNK,none,,none,,demerol ..pine trees,['Herpes zoster'],1,GLAXOSMITHKLINE BIOLOGICALS,IM 921223,WA,,M,Patient received second dose Pfizer-BioNTech COVID-19 vaccine on day 8 instead of day 21,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,UNK,"Citalopram 20 mg, Lisinopril 20 mg, Metoprolol 75mg, Lamotrigine 100mg",,"Hypertension, Anxiety, Depression",,,['Inappropriate schedule of product administration'],UNK,PFIZER\BIONTECH,IM 921254,OR,,F,"Moderna Covid 19 Vaccine surmounted a response of a fever 102.00, body aches, chills, dizziness, Patient did test positive for the Coronavirus earlier in December and had recovered, testing negative before receiving vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,,,12/22/2020,,UNK,,,previous positive Covid test,,,"['Chills', 'Dizziness', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 921372,NJ,77.0,F,"- Got the recommended dose of Shingrix on Jan 2, 2019 and April 19, 2019 - For the week before Oct 9, I had a severe constant headache on the left side of my head. I NEVER get headaches. - Oct 9 the left side of my nose near my left eye broke out with oozing sores and my face-cheek swelled up and got red. -Oct 11 I went to MD and diagnosed with shingles - the sores were on my the tip of my nose, and in my head on the left side.started Valtrex 3X/day -Oct 15 my left eye continued to water, and was very red. Went to the ophthalmologist who sent me from his office to the hospital for MRI evaluation of 6th Nerve Palsy caused by the shingles. (MRI was clear) - I stayed in the hospital for 7 days getting Acyclovir infusion 3X a day and neupogen 2X/day. - My neutrophils were .99 & .3 - I continued with Valtrex for 7 more - shingles finally healed up, but left my eye with double-vision (so far) and a numb nose where the shingles had been. I shouldn't have gotten shingles - I guess you can count me in the 10%. I have progressive pictures. Dr thinks the high Ferritin was a result of shingles etc",Not Reported,,Not Reported,Yes,,Not Reported,,,10/09/2020,,UNK,"Azelastine .1% 2 sprays (as need) Procrit 60,000 per week; Vitamin D3 1000 I.U. 1/day Folic acid 800 /day Allegra 180mg 1X/day",,MDS 5Q del,,environmental,"['Diplopia', 'Erythema', 'Full blood count', 'Headache', 'Herpes zoster', 'Hypoaesthesia', 'Lacrimation increased', 'Magnetic resonance imaging normal', 'Neutrophil count decreased', 'Ocular hyperaemia', 'Serum ferritin increased', 'Skin weeping', 'Swelling face']",UNK,GLAXOSMITHKLINE BIOLOGICALS,IM 917624,GA,46.0,F,"Malaise and Unable to perform ADL, Hot flashes, Muscular pain, headache, Insomnia from 12/31-1/2/2021, peripheral tingling or numbness on 1/2/2021. Took 800 mg Ibuprofen BID to help with symptoms,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,Vitamins,COVID POSITIVE-12/8/2020,NONE,,none,"['Headache', 'Hot flush', 'Hypoaesthesia', 'Insomnia', 'Loss of personal independence in daily activities', 'Malaise', 'Myalgia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 917625,MI,24.0,M,"Headaches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,None,None,None,,"Amoxicillin, Sulfa antibiotics","['Fatigue', 'Headache']",1,PFIZER\BIONTECH,IM 917626,CO,37.0,F,"6 days after vaccine date. I have enlarged, swollen and painful lymph node in my right axilla.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/01/2021,6.0,WRK,None,None,None,,None,"['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 917627,CA,28.0,F,"Muscle spasm on the L side of the neck and upper back. This resolved with rest, warm compress and gentle stretching. Soreness of the left arm as well as the L neck and scapular area continued for a few days after the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,Implanon birth control,,,,Sulfa,"['Arthralgia', 'Muscle spasms', 'Neck pain', 'Pain in extremity']",1,MODERNA,IM 917628,,38.0,F,Employee reported mild nausea for a few minutes but resolved. Reported feeling well after 15 minutes of monitoring.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,UNK,,,,,,['Nausea'],UNK,MODERNA,IM 917629,,60.0,M,Slight/mild soreness at the site of injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,UNK,,,,,,['Injection site pain'],UNK,MODERNA,IM 917631,SD,52.0,F,"Moderna COVID-19 Vaccine EUA The afternoon of the day I received my first injection I started with a headache. Upon waking the following morning I had injection site sore/stiffness, severe body aches, headache, joint stiffness, slight nausea at times and occasional dizziness. I developed a fever during the night and woke up with my clothing wet. My symptoms except for the injection site soreness were resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,"Atenolol, amitriptyline, citalopram, Lactobacillus, multivitamin, calcium, iron, biotin, vitamin b12, Zyrtec, miralax",none,"tachycardia (on atenolol) mild depression (on citalopram) seasonal allergies (on Zyrtec) sleep disorder (on amitriptyline) constipation (probiotic, miralax)",,omnicef,"['Dizziness', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Injection site reaction', 'Joint stiffness', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 917632,CA,74.0,M,Abdominal cramping and bloating Followed 10 hours later by watery diarrhea now improving,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/02/2021,2.0,PVT,lisinopril amlodipine finasteride Dulera,,hypertension asthma cerebrovascular stenosis aortic stenosis,,sulfonamides,"['Abdominal distension', 'Abdominal pain', 'Diarrhoea']",UNK,MODERNA,IM 917634,WA,46.0,F,Rash spreading both arms. Itching all over.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None,No,Migraine Seasonal allergies,,NKDA,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 917635,WA,25.0,M,"Fever of 100.7F, body aches specifically upper and mid back pain, soreness at site of injection, chills, general discomfort, difficulty falling asleep",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,PVT,Multivitamin,None,None,,None,"['Chills', 'Initial insomnia', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA, 917636,IL,24.0,F,"Day one after vaccine, red, swollen and tender about quarter size. Day 2 the area was more red and discolored and around the injection site looks like the skin was burn around it. Day 3 still tender but looks like a burn around the site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,WRK,Sprintec,No,No,,Penicillin and amoxicillin,"['Erythema', 'Injection site pain', 'Pain of skin', 'Skin discolouration', 'Skin swelling']",1,MODERNA,IM 917637,CA,26.0,F,"I was given the shot around 1 pm and didn?t have any reaction throughout the day besides my arm becoming sore around the injection area. I later went to bed and woke up from my sleep at 12am, shaking uncontrollably (It?s like I had the chills but the shaking was much worse that I contemplated going to the emergency room ). I felt very cold, my heart was racing,& I couldn?t catch my breath. The shaking lasted for about two hours. I finally fell back asleep and woke up again at 1am and woke up sweating, my whole body was hot and fighting off one of the worse fevers I had. Another hour passed as I tried to fall asleep and not soon after I was awoken from my sleep. At 3 am I woke up very nausea and also had to use the restroom , it felt like everything wanted to come out both ways. During this time time on the toilet I felt exhausted, dizzy, & my whole body was just aching. 2 hours later I finally fell asleep. When I awoke in the morning I still felt nauseous, had horrible body aches, & had the chills. I genuinely hope this helps someone else who May experience the same symptoms!",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,,,,,Cheetos and sunchip (seasoning),"['Chills', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Feeling cold', 'Feeling hot', 'Hyperhidrosis', 'Injection site pain', 'Nausea', 'Pain', 'Palpitations', 'Pyrexia', 'Sleep disorder', 'Tremor']",1,MODERNA,SYR 917638,CA,57.0,M,"Fatigue, Headache, Malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,UNK,"Asmanex, Singulair, Advair, Fasenra",None,Asthma,,NKA,"['Fatigue', 'Headache', 'Malaise']",1,PFIZER\BIONTECH,IM 917639,MO,59.0,F,Large soft as well as hard swollen lymph glands and nodes in neck and clavicular region and severe muscle aches and pains in upper body and neck.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/27/2020,6.0,PVT,None,None,Asthma,,"Latex, Ketek, Bactrim","['Induration', 'Lymphadenopathy', 'Myalgia', 'Neck pain']",1,PFIZER\BIONTECH,IM 917640,SC,52.0,F,"Fever, chills, sore arm expected and resolved in 24 hours. Unexpected bright red gums, bleeding between teeth 48 hours after. Will notify if doesn't resolve on its own.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/02/2021,2.0,SEN,None,None,None,,None,"['Chills', 'Gingival bleeding', 'Gingival erythema', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA,IM 917641,HI,54.0,F,"About 30 minutes after immunization, pt's eyes were red and slight swelling under the eyes. No reports of swelling of tongue/lips/or trouble breathing. Pt states she was feeling ok. Administered Benadryl to patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,PHM,,,,,,"['Eye swelling', 'Ocular hyperaemia']",1,MODERNA,IM 917642,CA,40.0,F,"24-48 hrs of localized edema, soreness which completely resolved. Then, 6 days after injection I awoke with tremendous localized itching and edema and erythema. It lasted 24 hrs approx.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/25/2020,01/01/2021,7.0,UNK,"Birth control, Claritin",,,,,"['Erythema', 'Localised oedema', 'Pain', 'Pruritus']",UNK,MODERNA,IM 917643,TN,30.0,F,"Become tired after returning home from getting the vaccine. I fell asleep and woke up to large hives on my face. Not much longer and the hives/itching spread down my back and chest. Face became swollen. Benadryl cream was initially attempted, but only briefly subsided the itching and reaction continued spreading. I took oral quick release Benadryl and was able to prevent the reaction from continuing. I had to take a secondary Benadryl dose a few hours later and extreme joint pain accompanied the allergic reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2020,01/02/2021,366.0,OTH,"Tylenol, zyzol, Flonase",,Stage 3 Steatosis of liver,,"Codeine, Zithromax, penicillin, naproxen, Straterra","['Arthralgia', 'Fatigue', 'Hypersensitivity', 'Pruritus', 'Swelling face', 'Urticaria']",1,PFIZER\BIONTECH,SYR 917644,WA,43.0,F,"I felt weak, my heart rate went up to 120's, my SBP went up to 150's, I had SOB and felt I was thirsty and I need air and I had severe headache few minutes about 5 -20 minutes after I had shots. I took Ibuprofen for severe headache and sore on my Left upper arm at the injection site. Yesterday 1/2/21 I observed at the injection site has some redness in circular area, warmth to the touch and slightly sore. I met my PCP last 1/28/20 and had my physical exam.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,none,none,gestational diabetes,,none,"['Asthenia', 'Blood pressure systolic increased', 'Dyspnoea', 'Headache', 'Heart rate increased', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Thirst']",1,MODERNA,IM 917645,GA,51.0,M,Generalized Body Aches Fever 102.4 ( today AM) Nausea Rigors and Chills all Night. Severe Headache. Uneasy Gut. Pain at Site and Neck,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,WRK,Lisinopril Tamsulosin Janumet Omeprazole,,Type 2 DM BPH GERD Obesity,,Penicillin,"['Abdominal discomfort', 'Chills', 'Headache', 'Injection site pain', 'Nausea', 'Neck pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 917646,VA,26.0,M,"Temperature 100.7 temporal, fevers chills, mild injection site tenderness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,WRK,Truvada,None,None,,None,"['Body temperature decreased', 'Injection site pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917647,NC,40.0,F,"Bilateral hand swelling and joint pain lasting 4 days, extremely enlarged axillary lymph nodes 5days post vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,PVT,"probiotic, magnesium, thyroid vitamin, senna, famotidine",,,,,"['Arthralgia', 'Lymphadenopathy', 'Peripheral swelling']",1,MODERNA,IM 917648,CA,44.0,F,"Malaise, nausea, bosy aches mild joint pain - started 12 hours post vaccination and resolved 48 hours later. Upper axillary lymphadenopathy - started 5 days post-vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/26/2020,0.0,PVT,None,None,None,,None,"['Arthralgia', 'Lymphadenopathy', 'Malaise', 'Nausea', 'Pain']",1,MODERNA,SYR 917649,OH,29.0,F,"Fever, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/03/2021,3.0,UNK,,,,,,"['Headache', 'Pyrexia']",1,MODERNA,UN 917650,,30.0,F,"Symptoms started 01/01/2021 at 14:30 - Body aches, chills, and very sore arm at the site of injections. 01/02/2021 at 01:30- Woke up with an elevated temp of 100.0 F, body aches, chills, sore left arm, and general fatigue 01/02/2021 at 10:30- Normal temp again, but still experiencing body aches, chills, sore left arm, general fatigue, and general lack of appetite. 01/02/2021 at 18:30- starting to feel slightly better, regained appetite. Normal temp. Still experiencing body aches and fatigue. 01/03/2021 at 08:00- woke up feeling better. The only lasting side effect is a sore and swollen arm at the site of injections",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,MIL,"Biotin 1000mcg for hair, skin, and nails",none,COIVD POSITIVE In November,,NKA,"['Chills', 'Decreased appetite', 'Fatigue', 'Injection site pain', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 917651,IL,32.0,F,Fever of 100.5 and severe headache.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/03/2021,1.0,PVT,,,,,,"['Headache', 'Pyrexia']",1,MODERNA,IM 917652,PR,25.0,M,1 week and 2 days post vaccination I woke up with a tender reactive axillary lymph node in the left extremity. Around this same time erythema and a mild pruritus was noticed at vaccination site. Area was warm to the touch. No treatment was started.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/02/2021,9.0,UNK,None,None,None,,None,"['Lymph node pain', 'Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site warmth']",1,MODERNA,IM 917653,MA,33.0,M,"The evening on the day of my vaccination, I started having fever 101 F, chills and myalgia. This happened after the 1st dose of the vaccine. Fever lasted 3 days (up until 1/2/2021) at noon and was ranging between 100.9 and 101. Fever responded well to Advil.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,COVID-19 (3 weeks prior),,,,"['Chills', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 917654,NH,27.0,F,Severe arm pain at injection site Stomach pain Nausea Vomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,Tri-sprtntec (birth control) Biotin Femdophilus,None,None,,None,"['Abdominal pain upper', 'Injection site pain', 'Nausea', 'Vomiting']",UNK,MODERNA, 917655,UT,34.0,F,"On Tuesday 12/28 I started to have severe leg pain in my right leg. The next morning the pain was still in the right leg and had moved up through my right side in my joints to my knee, hip then went to the with shoulder down that arm. My forearm became very painful on 12/30 and started to swell then radiated into my wrist joint and finger joints. 12/31 the pain continued in all those areas and had moved to my left side of my body starting with the left arm following the same course as the right side. On 1/1 the pain has persisted and I am unable to perform any ADL's. I saw an urgent care physician who told me to take ibuprofen. I have been taking ibuprofen and Tylenol with no relief. Now all my joints are swelling in bilateral hands, wrist. On 1/2 my bilateral ankle joints and feet started to have similar pain. Know all my extremities are difficult to use and it is hard to walk due to the pain. Because of the pain in my hands things feel heavier than what they should. I am a medical provider and this almost seems like polyarthralgia rheumatica, I am going to go see a physician on Monday",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/29/2020,8.0,PVT,none,None,ASD Mast Cell Activation Syndrome,,none,"['Arthralgia', 'Gait disturbance', 'Joint swelling', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Pain', 'Pain in extremity', 'Peripheral swelling']",UNK,PFIZER\BIONTECH, 917656,MI,30.0,F,"Arm became very sore about 10 hours after the vaccine. Around 12 hours later became very sore throughout entire body, had very bad chills, and was unable to sleep. By 9 am I was finally able to sleep one hour and awoke sweating, but chills had subsided. Body aches did not subside until Wednesday morning (vaccine was administered Monday).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,UNK,"Lisinopril, norethindrone, multivitamin, vitamin D.",Covid 19 in November.,,,,"['Chills', 'Hyperhidrosis', 'Pain', 'Pain in extremity', 'Sleep disorder']",1,PFIZER\BIONTECH,SYR 917657,,33.0,F,"Around 9 pm after receiving the vaccine, I started having chills, body aches, and a fever. I still have these today.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,UNK,daily prenatal vitamin,none known,none,,none known at this time,"['Chills', 'Pain', 'Pyrexia']",1,MODERNA,SYR 917658,CO,58.0,F,"RED BUMPY RASH, ITCHING. AT INJECTION SITE @ 2 X2.5 INCHES",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/02/2021,10.0,WRK,"ENBREL, ULTRAM, IBUPROFEN(600MG), CLARITON, VITB12, VITC, VIT E",,"ANKYLOSING SPONDYLITIS, MGUS",,PENICILLIN,"['Injection site pruritus', 'Rash erythematous', 'Rash papular']",1,MODERNA,SYR 917659,NY,68.0,F,Exhaustion Sleepiness Dizziness Joint pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,UNK,Rosuvastatin 10mg Multivitamin,None,,,Kiwi Omnicef Kenalog,"['Arthralgia', 'Dizziness', 'Fatigue', 'Somnolence']",1,PFIZER\BIONTECH,SYR 917660,IL,34.0,F,"Developed injection site redness circular in shape approximately 3cm in diameter the following day after vaccine administered. Redness, itching and pain at site continued for 5 days. Then developed into a bruise, still have visible bruising at site. Used ice packs to area to alleviate itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/20/2020,1.0,PVT,Prenatal vitamin,None,None,,Amoxicillin,"['Injection site bruising', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus']",1,PFIZER\BIONTECH,IM 917661,MA,36.0,F,HSV1 reactivation,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/31/2020,5.0,PVT,"Levothyroxxine, MVI",No,Hypothyroidism,,"Ceclor, PCN, iodine",['Herpes simplex reactivation'],1,MODERNA,IM 917662,,51.0,F,"?Moderna COVID-19 Vaccine EUA? Itching at site within 10 minutes Nausea, vomiting, diarrhea within 1hour",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,MIL,Synthroid,None,"Asthma, hypothyroidism, GERD",Anaphylactic shock,Hepatitis B Vaccine,"['Diarrhoea', 'Injection site pruritus', 'Nausea', 'Vomiting']",1,MODERNA,IM 917663,IA,50.0,M,"Severe nausea, dizziness, light headed, chills, vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,PUB,Multi-vitamin,None,None,,None,"['Chills', 'Dizziness', 'Nausea', 'Vomiting']",UNK,MODERNA,IM 917664,WI,32.0,F,"Pfizer-BioNTech COVID-19 vaccine EUA Moderate injection site soreness and stiffness, mild body aches, chills, headache and runny nose Symptoms started within 12 hours of receiving.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/03/2021,1.0,PVT,None,none,none,,Nickel,"['Chills', 'Headache', 'Injection site pain', 'Musculoskeletal stiffness', 'Pain', 'Rhinorrhoea']",1,PFIZER\BIONTECH,IM 917665,GA,22.0,F,"Rash on lower right leg above the ankle appeared the evening of the shot. One spot was visible on the upper left arm the day after the shot. On the third morning after the shot, at 3 a.m., was awakened to a racing heart. The racing heart was on and off until I got out of bed at 7 a.m.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PUB,,,,,None known,"['Palpitations', 'Rash', 'Rash macular']",1,PFIZER\BIONTECH,IM 917666,ME,60.0,F,"face and neck turned bright red with a rash, body started shaking felt wobbly or off center. Treated with Benadryl.. Next day worse shakes feel lame with knee pain and joint pain. Severe arm pain. on third day still shaking brain for and joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,none,none,none,,"cipro, mold, steroids","['Arthralgia', 'Balance disorder', 'Erythema', 'Head titubation', 'Pain in extremity', 'Rash', 'Tremor']",UNK,MODERNA,SYR 917667,AL,47.0,F,"Most horrible fever, chills, body aches, near syncope.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,Tylenol,None,"Rheumatoid Arthritis, SAR",,Betadine,"['Chills', 'Pain', 'Presyncope', 'Pyrexia']",1,MODERNA,IM 917668,TX,45.0,F,Tachycardia and palpitations started when I laid down the bed to sleep for the night.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,"Vitamins B, C, D and Omega 3",None,None,,None,"['Palpitations', 'Tachycardia']",UNK,MODERNA, 917669,WA,30.0,F,"Night sweats beginning at unknown time, noticed upon waking at 6:00 AM. Heart rate about 20 points higher than normal throughout course of sleep as evidenced by Apple Watch data.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/03/2021,1.0,PVT,Multivitamin Vitamin C + Zinc Vitamin D Vitamin B12,None,None,Lymphadenopathy from flu vaccine at age 29 years.,"Allergic to Sulfa medications Allergic to cats, horses, bunnies",['Night sweats'],1,MODERNA,IM 917670,VT,68.0,F,"After receiving vaccine, c/o burning throat, coughing, face itching, hot flashes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,,,,,,"['Cough', 'Hot flush', 'Pruritus', 'Throat irritation']",1,PFIZER\BIONTECH,IM 917671,NJ,63.0,F,"Woke up with chills, Myalgias, arthralgias , HA , . Next day also developed Rhinorrhea and fatigue. Same symptoms continued for about 48 hrs then felt better but still with some arthralgias and fatigue. I had covid-19 virus in MArch 2020. Felt pretty much the same way post vaccine as I felt then. Wondering if this reaction could be due to fact that I had virus previously and also wondering about second dose? Have there been reports of worse S/E in people who have had virus previously?",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Rhinorrhoea']",1,MODERNA,IM 917672,IL,62.0,M,"whole body muscle aches, chills, fever over 101, light headed/dizzy (fainted), fatique, some nausea. all disapated within 48 hours of getting shot",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,"HRT, Synthroid, Zolaft",Covid positive on 11/19/2020,,,,"['Chills', 'Dizziness', 'Fatigue', 'Myalgia', 'Nausea', 'Pyrexia', 'Syncope']",UNK,MODERNA, 917673,NH,45.0,F,"fever, chills, body aches, headache, fatigue lasting 24hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,"Biotin, Vitamin D",none,"GERD, h/o breast cancer",,PCN,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 917675,NH,31.0,F,"Injection at 2 PM left arm Around 5:30 PM that same evening I developed a migraine, then shortly after that I felt shaky nausea vomit Feverish with no fever chills entire body achyLeft arm severely painful unable to lift loss of strength with opening anything these Symptoms went on for about five days then I developed left arm weakness two days after the symptoms went away and neck pain only to the left side",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,OTH,Adderall Synthroid Trintellix Albuterol,Nothing,Asthma Hypothyroidism,,Penicillin Latex,"['Asthenia', 'Chills', 'Migraine', 'Nausea', 'Neck pain', 'Nervousness', 'Pain', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 917676,TX,50.0,F,"7:20 AM - 10 minutes after taking thyroid medication, developed low blood pressure, low heart rate, cramping abdominal pain, chills and hypothermia.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PVT,Time of Vaccination medications Taken: -Euthyrox -Cytomel,NONE,Thyroidectomy Post-Surgical Hypothyroidism Ovary sparing Hysterectomy,,NKDA,"['Abdominal pain', 'Chills', 'Heart rate decreased', 'Hypotension', 'Hypothermia']",1,MODERNA,IM 917677,ID,53.0,F,"Right arm pain, nausea, muscle aches, rash/hives",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,UNK,,none,none,"fever, rash, body aches, 52, Shingrix, June 13, 2020",penicillin,"['Myalgia', 'Nausea', 'Pain in extremity', 'Rash', 'Urticaria']",1,MODERNA,IM 917678,NJ,40.0,F,red raised pin point skin rash with puritis. upper torso front and back. treated with benadryl and zyrtec and cortisone cream,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,wellbutrin zoloft vitamin c zyrtec benadryl albuterol inhaler,no,"mitral valve prolapse, depression, seasonal allergies",,"sea fish, morphine","['Rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,SC 917679,IN,37.0,F,chills and face felt flushed,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,none,none,none,,none,"['Chills', 'Flushing']",2,PFIZER\BIONTECH, 917680,CT,66.0,M,"About 7 days after injection, left deltoid muscle became swollen, hot and tense to touch. Initially after injection has local tenderness and small swelling but seems to resolve after 2-3 days. Was feeding tired the first two days. Then on Saturday a week after injection, felt a slight itchiness on left deltoid area and then as the day progressed, the swelling became more prominent. Still confine to the deltoid area.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,PVT,"Nifedipine, metoprolol, valsartan, multivitamin (one a day), glucosamine, Vit. B6",None,None besides blood pressure treated with above meds,,None,"['Fatigue', 'Feeling hot', 'Muscle swelling', 'Pruritus', 'Tenderness']",1,MODERNA,IM 917681,GA,60.0,F,"No symptoms or pain with initial injection. I came home about 2 hours after the injection and took one 200mg ibuprofen and one 500mg acetaminophen and put an ice pack on the site briefly. Later that afternoon I developed pain at the injection site that progressively got worse over the course of the evening so bad that I could not raise my left arm of touch the site. I put an ice pack on again and that night I slept with a heating pad on. I would rate the pain 8/10. When I woke the next day the pain was still there, but not as severe. I got in the shower and let the hot water beat on the injection site and that seems to help a lot. The pain gradually lessened over the course of the day to a 2/10. By the following day (3rd day post injection) the pain had completely subsided. There was no redness or swelling at the site and I did not have any other symptoms other than the intense injection site pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None,None,Low back pain,,"Minocin, Dilaudid, almonds","['Injected limb mobility decreased', 'Injection site pain']",1,PFIZER\BIONTECH,IM 917682,PA,29.0,F,"Headache, fatigue, hot flashes, diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,WRK,"Kelnore birth control, adult gummy multivitamin, zinc",None,None,,None,"['Diarrhoea', 'Fatigue', 'Headache', 'Hot flush']",1,MODERNA, 917683,TN,39.0,M,Loss of taste and smell after 3-4 days after injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/01/2021,4.0,OTH,,,,,,"['Ageusia', 'Anosmia']",UNK,MODERNA, 917684,,30.0,F,"The night of getting the vaccine I was the sickest; fatigue, malaise, body aches, hot and cold sweats, weakness, loss of appetite, dizziness. The day after I had to call into work due to these symptoms. Since then I?ve continued to feel fatigue, throat swelling / scratchiness, dry cough, malaise. Also arm soreness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,UNK,"Collagen, multivitamin",None,None,,None,"['Asthenia', 'Cold sweat', 'Cough', 'Decreased appetite', 'Dizziness', 'Fatigue', 'Hyperhidrosis', 'Illness', 'Impaired work ability', 'Malaise', 'Pain', 'Pain in extremity', 'Pharyngeal swelling', 'Throat irritation']",UNK,MODERNA,IM 917685,CO,58.0,F,Arm was quite sore for about 24 hours at injection site. Had a Body aches and slight chills for about 7 hours the next day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,UNK,"Pantoprazol, Famotidine, Calcium, Magnesium,Zinc, D3, B12, C",Tested positive for Covid 1 month prior,"Gastritis, Hiatal hernia, Duodenitis, Acid reflux",,,"['Chills', 'Injection site pain', 'Pain']",1,MODERNA,SYR 917686,PA,28.0,F,"Vaccine was taken on 1/2/2021 at 3:30 PM. At 1:20 AM- developed chills, teeth chattering, could not get warm (no fever) 3:20 AM- woke up feeling hot- 101 F developed and headache 4AM- took aleve 6AM-temp 98.7. still a headache. woke up drenched in sweat 8:20AM: still pounding headache. temp 98.8",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/03/2021,1.0,PVT,None,mild sore throat on 12/20/2020. Covid negative,none,,None,"['Chills', 'Feeling cold', 'Feeling hot', 'Headache', 'Hyperhidrosis']",1,MODERNA,IM 917687,,70.0,M,"Fever, Chills, Soreness at injection sight, in early AM 12 hr after injection. Fatigue, Fever 100 F to 101 F with chills off and on until 01/02/20 afternoon. treated with Tylenol. rest helped and fever would break with sweats. Body aches for first 24 hours after symptoms started. gaseous loose BM's. no nausea, no appetite.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,"Lovaza, losartan, chlorthalidone, Effient, ASA 81mg, Bystolic, Fibercon, Coenzyme Q-10, Crestor, Flomax, vitamins and minerals. Tylenol, hydrocodone, lorazepam prn",percutaneous coronary intervention,"HBP, high cholesterol, heart vascular blockage, back pain, arthritis",polio injections 1950's and early 1960's (less severe),,"['Chills', 'Decreased appetite', 'Diarrhoea', 'Fatigue', 'Flatulence', 'Hyperhidrosis', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 917688,NY,42.0,F,"After receiving vaccine, c/o heart racing, palpitations, pulse- 100-120, hot flash, scratchy throat, c/o ""tonsil swelling""....",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,WRK,,,,"15 yrs ago, in ER, ? IV Erithromycin/Reglan/Zantac... unknown which drug caused reaction",,"['Hot flush', 'Palpitations', 'Throat irritation', 'Tonsillar hypertrophy']",1,PFIZER\BIONTECH,IM 917689,IN,58.0,M,"Non-Pruritic Rash on Trunk and Back, Fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/18/2020,2.0,PVT,Adderal,,,,CT dye,"['Fatigue', 'Rash']",1,PFIZER\BIONTECH,IM 917690,FL,35.0,F,"After getting the shot, my left arm was in pain for 3 days. On the 3rd day I got a swollen an painful left axillary lymph node. On the 7th day of getting the shot I started with fever, chills, body ache, flu like symptoms. Is January the 3rd and I still have flu like symptoms, no more fever dough.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/27/2020,3.0,PVT,,,,Flu vaccine and I had fever the same day.,,"['Chills', 'Influenza like illness', 'Lymph node pain', 'Lymphadenopathy', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 917691,VT,25.0,F,"After vaccine administration, c/o tingling mouth, jaw tightness, tongue burning sensation on sides of mouth, nausea, dizziness, shaky",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,WRK,,,,,Has EpiPen for shellfish Hx of rash with IV meds (not specified),"['Dizziness', 'Muscle tightness', 'Nausea', 'Paraesthesia oral', 'Tongue discomfort', 'Tremor']",1,PFIZER\BIONTECH,IM 917692,TX,44.0,F,"Body aches, fever, soreness at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,"Levothyroxine, birth control",,,,NSAIDS,"['Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA, 917693,NY,58.0,F,Headache severe cannot relieve with 800 mg IBUprofen,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,WRK,"Farxiga, Lisinopril-HCTZ, Adderall, Cetirizine,Esomeprazole Magnesium",None,"HTN, Narcolepsy, DM-2, Depression, Migraines, Obesity",,Jack Fruit and Benadryl,['Headache'],1,MODERNA,IM 917694,MD,39.0,F,"Face became numb 25 minutes after vaccine administered. Relief came the next morning 12/22/2020, 0700.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,Junel Celexa Multi Vitamin,None,None,,Penicillin,['Hypoaesthesia'],2,PFIZER\BIONTECH,IM 917695,CO,30.0,F,"Subscapular lymphadenopathy on left side of the back just behind the left shoulder. 2 swollen, sore lymph nodes noted 5 days after vaccine. So far, still present 7 days later.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/28/2020,5.0,PVT,None,None,None,,None,"['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 917696,PR,53.0,M,"2 days after injection , the injection site become painfull and resilve un 48 hours, but on 1/2/2021 started to get swollen redness and very hard and firm , also the ventral aspect of the arm felt swollen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,01/02/2021,32.0,OTH,Syrtroid,None,None,,No,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Peripheral swelling']",1,MODERNA,IM 917697,CO,38.0,F,"I woke up on 12/30/20, one week to the day after my vaccine with an itchy red rash on my left arm about 2 inches below the vaccine site. It worsened throughout the day becoming larger, more red, hot and tender to touch. By the end of the day on 12/31/20 the rash was 5-6x bigger than when it started. I saw my PCP via telehealth appt that day and it was determined I likely have cellulitis based on presentation and symptoms. I started taking doxycycline that day and symptoms started to improve.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PVT,Zoloft (50mg),None.,"History of Gutate Psoriasis, hayfever, anxiety, & depression.",Rashes to vaccines as a child per my mother.,"Allergic to Penicillin and all related drugs, Sulfa Drugs, Codeine, Cefzil, Clindamycin, Humibid Known allergy/food sensitivity to dairy, wheat, & eggs.","['Rash erythematous', 'Rash pruritic', 'Vaccination site cellulitis', 'Vaccination site pain', 'Vaccination site reaction', 'Vaccination site warmth']",1,MODERNA,IM 917698,PA,36.0,F,"PT RECEIVED INJECTION AND WAS ASKED TO STAY FOR OBSERVATION AND WAS INSTRUCTED TO NOTIFY NURSE OF ANY CHANGES IN CONDITION. AFTER APROX 5 MINS PT REPORTED SOME NAUSEA AND ASKED TO BE SHOWN TO NEAREST REST ROOM. WALKED WITH PT TO LADIES ROOM, WAITED CLOSE BY AND CHECKED ON HER TWICE. WAS IN REST ROOM FOR APROX 15 MINS. WHEN SHE EXITED ASSISTED HER BACK TO OBSERVATION AREA. REPORTED DIARRHEA AND CONTINUED NAUSEA. ASSESSED BLOOD PRESSURE. 85/51. CALLED FOR RRT. TEAM ARRIVED AND ASSESSED PT. PT REPORTED CONTINUED NAUSEA, WEAKNESS, CHILLS, AND APPEARED LETHARGIC. PT REPORTED TO ED BY RRT.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,PVT,NONE REPORTED,NONE REPORTED,NONE REPORTED,,NO KNOWN ALLERGIES,"['Asthenia', 'Chills', 'Diarrhoea', 'Lethargy', 'Nausea']",1,MODERNA,IM 917699,NJ,36.0,F,Fever. For 2 days Severe Body aches Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,,,,,,"['Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917700,OK,29.0,F,"Itchy rash at injection site starting one week post injection, swollen lymph node in a right arm pit",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/27/2020,4.0,PVT,"Corlanor, Prozac, Prilosec, vitamin d, Claritin, singulair, synthroid, Liletta IUD",,"Bipolar disorder, inappropriate sinus tachycardia, Ehlers Danlos syndrome, asthma",,"Penicillin, ceclor, sulfa, metals","['Injection site rash', 'Lymphadenopathy', 'Rash pruritic']",1,MODERNA,IM 917701,MA,44.0,F,"My head felt like It was under water, had sinus issues, headache and vaccine sight issues days after getting the vaccine, warm, red and pain at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/01/2021,6.0,WRK,None,None,None,,None,"['Headache', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Sensory disturbance', 'Sinus disorder']",1,MODERNA,IM 917702,PA,36.0,F,"On 12/29: lightheadedness, flushed, felt like I was going to pass out, numbness/tingling down arms and hands, chest tightness, clammy hands and feet.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/24/2020,12/29/2020,5.0,PVT,Vitamin D 2000 iu daily Melatonin 7.5mg daily Mirena (IUD inserted 4/2016),None,None,,Percocet: itching,"['Blood potassium decreased', 'Chest discomfort', 'Cold sweat', 'Dizziness', 'Flushing', 'Hypoaesthesia', 'Laboratory test normal', 'Paraesthesia']",1,MODERNA,IM 917704,ME,62.0,F,"Approximately 12 hours after injection, sudden onset headache, went to bed and woke a couple hours later with severe back pain, neck pain, deep muscle ache in legs, low grade fever. 24 hours after injection, some decrease in pain with Tylenol, diarrhea, fatigue, general malaise. Loss of taste, loss of appetite . 48 hours post injection- subsiding muscle aches, other symptoms on going, 72 hours post to present, diarrhea, loss of appetite",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PHM,Venlafaxine 150mg x1 daily,"COVID positive 11/21/2020 Headaches, muscle aches, low grade fever, loss of smell/taste, fatigue, diarrhea",None,,None known,"['Ageusia', 'Back pain', 'Decreased appetite', 'Diarrhoea', 'Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Neck pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917705,TX,44.0,F,"I got covid-19 vaccine in campus 12/30/2020 around 11 Am . I felt sick around 11 pm (12 hours later , 12/30/2020). I felt dizziness , Chills , facial swelling and body aches for 24 hours . I took Benadryl and Tylenol every 8 hours . I felt better in 1//1/2010 around noon.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,UNK,NO,No,Asthma,,No,"['Chills', 'Dizziness', 'Malaise', 'Pain', 'Swelling face']",1,MODERNA,IM 917706,AL,70.0,F,"Swelling and Redness at injection sight from quarter coin size to half dollar with pain. Myalgia, Fatigue, fever 101.3 F. Nausea and diarrhea. dizziness. (main problems of fever and bodyaches) treated with tylenol, zofran, lomotil, rest. no appetite. facial swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Neurontin, Advil, Tylenol, Singulair, estrogen oral, Parafon, Vistaril, vitamins minerals, folic acid, certirizine, Zofran, ASA 81mg, Lomotil, lorazepam, hydrocodone, antacids, fibercon, anti-gas",,"osteo arthritis, chronic back and hip pain, IBS-type symtoms with constipation and diarrhea,",smallpox 1957,,"['Decreased appetite', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Swelling face']",1,MODERNA,IM 917707,MI,56.0,F,"nosebleeds X 3 12/31, 1/1 and 1/2 treated with pressure and ice",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,"nexium, abilify, lexapro, synthroid, qvar",Covid 19 15 days prior,"asthma, hypothyroid",,morphine,['Epistaxis'],1,MODERNA,IM 917708,MD,57.0,F,Dizziness and nausea for 24 hours: resolved with rest and hydration,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PUB,"Pristiq 10 mg, Metamucil, Melatonin 10 mg",none,none,,PCN,"['Dizziness', 'Nausea']",UNK,MODERNA,IM 917709,IL,57.0,F,Recipient reported seeing some red rash to arms approximately 10 minutes following vaccine. Benedryl given 50mg IM to Left Deltoid. Patient kept for additional observation.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,"Vitamins and supplements, Antivio",,Crohn's Disease,Localized site reaction - hives and swelling in area around vaccination,NKDA,"['Rash', 'Rash erythematous']",1,MODERNA,IM 917710,NY,37.0,F,"I received the vaccine on 12/29 at about 2:15pm. I had a sore left arm after shot which awoke me at 2am. I also work up due to fever (temp 100.1 ), chills, and myalgia. I had a lot of trouble sleeping that night and got very little rest as unable to get comfortable. The next day I still had fever, chills, myalgia, nausea, joint pain, low back pain, fatigue and headache (felt similar to prior bad flu symptoms). I was sent home from work early as symptoms continued throughout the day with a little relief from a 500mg of acetaminophen. The following day 12/31 symptoms were gone except for the left sore arm which was improving and now completely done on 1/3.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,prenatal vitamins vitamin D supplement,None,Depression,,Amoxicillin- urticaria,"['Arthralgia', 'Back pain', 'Chills', 'Fatigue', 'Headache', 'Impaired work ability', 'Myalgia', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Sleep disorder']",1,MODERNA,IM 917711,KY,32.0,F,"100.6 fever, headache, chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/02/2021,1.0,PVT,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917712,NY,24.0,F,"Anaphylaxis. The COVID shot was given, no reaction then. After 7 minutes, congestion, severe cough, vomiting phlegm, feeling like throat closing started happening. Code was called, Benadryl was immediately given intramuscular in the left arm, blood pressure, pulse ox was taken, and then was taken to the Emergency Department. In the ED, I was given prednisone, one EPI, anti-nausea medication all through I.V. and many more medications given to me via I.V. that I don't sincerely remember. I was under observation for 4 hours. I was discharged after all symptoms dissipated and was given Prednisone 20 MG (3 tabs a day) to take to help my lungs. Management followed up almost immediately, everyone from the moment I had the anaphylactic reaction was quick and prepared.",Not Reported,,Yes,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,ESCITALOPRAM 20 MG TAB VITAMIN D3 5000 IU (125 MCG),NONE,ANXIETY DEPRESSION,,SHELLFISH SEAFOOD ALL OF THE PENICILLIN GROUP ANTIBIOTICS,"['Anaphylactic reaction', 'Chest X-ray', 'Cough', 'Productive cough', 'Respiratory tract congestion', 'Throat tightness', 'Vomiting']",1,PFIZER\BIONTECH,IM 917713,NY,64.0,M,"Pain at injection site; much less than flu shot. No treatment. Resolved by Jan 2. Brief bouts of dizziness and nausea; stayed home from work and rested. resolved by Jan 1. Seasonal allergy symptoms- runny nose, including bloody nose from left nostril. Resolved by Jan 2. Allergic reaction to a scented hand cream used by wife- burning eyes, nasopharyngeal tightness, nasal discharge. Wife since removed so I can't tell you brand. Occurred/Resolved Jan 1 when product was removed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Metformin, Glimepiride, Victoza, Jardiance, Rosuvastatin, Tresiba",Diabetes T2; 5 yrs post T1B2 Kidney cancer,Diabetes T2; 5 yrs post T1B2 Kidney clear cell carcinoma,Influenza vaccine Sept. 2020-pain at injection site x 3 days. Tylenol,,"['Dizziness', 'Impaired work ability', 'Injection site pain', 'Nausea']",UNK,MODERNA,IM 917714,PA,43.0,F,"Racing heart, dizziness, lightheadedness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Biotin, Vit C, edelberry, b12, calcium with d3",None,L breast cancer on remission 7 yrs,,Sulfa,"['Dizziness', 'Palpitations']",1,PFIZER\BIONTECH,SYR 917715,CA,32.0,F,"Day 4 after receiving vaccine dose developed nerve pain in the groin and R glute/thigh, as well as fatigue. Sx worsened on day 5, so I had a virtual visit with a medical provider who prescribed me Valtrex x7d to treat suspected Herpes Zoster, which I previously had in my early 20s.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/25/2020,4.0,PVT,Sertraline,,,,Sulfa,"['Condition aggravated', 'Fatigue', 'Groin pain', 'Herpes zoster', 'Musculoskeletal pain', 'Neuralgia', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 917716,TX,43.0,F,"Nauseous, Jitteriness, Tachycardia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PUB,,,,,,"['Feeling jittery', 'Nausea', 'Tachycardia']",1,MODERNA,IM 917717,PA,,U,"1 -1/2 hours after vaccine I statred with a mild headache that is still lingering, Jan.1st I was fine, Jan 2nd I had fatigue, by night time I had mild body aches, mouth pain, sinus pressure, swollen gums, and extreme fatigue. Jan 3rd mild sinus pressure, only left arm pain into arm pit area, neck pain and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PVT,,,,,,"['Axillary pain', 'Fatigue', 'Gingival swelling', 'Headache', 'Neck pain', 'Oral pain', 'Pain', 'Pain in extremity', 'Paranasal sinus discomfort']",1,MODERNA,IM 917718,OR,19.0,F,"Patient experienced a headache, arm pain (not at site), dizziness when standing. Patient was offered water and snacks. Sat in observation area for 30 minutes. Headache and dizziness with standing continued, after 30 minutes patient reported chest tightness. Caregiver was immediately taken to the Emergency Room for assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,PVT,,,,,,"['Chest discomfort', 'Dizziness postural', 'Headache', 'Pain in extremity']",1,MODERNA,IM 917719,WI,35.0,F,"Woke up Friday, 1/01, with sinus pain. Specifically burning pain in my sinuses and pain when I moved my eyes from right to left. Also had a generalized headache and body aches. On Saturday, 1/02, did have a fever of 100.2 but this has resolved. This morning, 1/03, the sinus pain has improved, still a slight headache and now major conplaint is lower back pain. Also have general malaise. No fever today either.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/01/2021,4.0,PVT,"Zyrtec, zinc, vitamin c, and vitamin d.",None,Asthma,,Penicillian,"['Back pain', 'Eye pain', 'Headache', 'Malaise', 'Pain', 'Pyrexia', 'Sinus pain']",1,PFIZER\BIONTECH,IM 917720,FL,73.0,M,"*THE BELOW IS A LIST OF SYMPTOMS THAT ARE ONGOING SINCE INJECTION DATE: 12/30/2020 0830 HOURS- *FEVER HOLDS AT 100.5 -101.9 * OVER THE COUNTER TYLENOL REDUCES FEVER BY 1-1.5* *CHILLS , FATIGUE, JOINT & MUSCLE PAIN AND LO GRADE HEADACHE( ALL SEEM TO MARGINALLY LESS TODAY *DRY INTERMITTANT COUGH OVER LAST 12 HOURS *CHRONIC CONSTIPATION, NO BOWEL MOVEMENT OVER THE PAST THREE DAYS",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,LOSARTAN 25MG,NONE,NONE,,NONE,"['Arthralgia', 'Chills', 'Constipation', 'Cough', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 917721,WI,29.0,M,"Signs and symptoms started around 1700hrs which included: body aches, chills, fever, and pain in the arm. Signs and symptoms resolved the following morning (1/1/21) 0800hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,WRK,None,None,None,,None,"['Chills', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 917722,FL,36.0,F,Received shot at 11:45 am. At 1700 that day developed sensation of racing heart and resting heart rate was 120. Baseline heart rate 80 at rest. This resolved overnight and returned to normal the next day. On 12/31/2020 develop sore throat and noted red vesicle like rash on my throat with petechia on my cheeks (buccal mucosa) and tongue. Swollen uvula. I had a medrol dose pack and Benadryl which I started immediately and rash/sore throat petechia resovlved 36 hours after starting the Medro dose pack. Unsure if this was related the vaccine but wanted to report just in case.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"Nexium, Pepcid, Tumeric/ginger tea, Tylenol, ibuprofen",None,GERD,,Bactrim,"['Enlarged uvula', 'Heart rate increased', 'Mouth haemorrhage', 'Oropharyngeal pain', 'Palpitations', 'Petechiae', 'Rash', 'Rash erythematous', 'Rash vesicular']",1,MODERNA,IM 917723,IN,57.0,F,"With in 12 hours of the vaccine I woke up with 101 fever, chills, all over pain and nausea with vomiting a few times. Large amount of arm swelling and erythema about 5inches wide and 6 inches long. L had was tingly and painful. Nauseated most of the next day and feverish on and off all day as well ranging from 99.0 to 101.2 . L arm remains red, tender and itchy and it is 1/3/2021. Was unable to work 12/31/2020. treatment included. ibuprofen, Tylenol, Aleve, ice, and rest",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,SEN,"Meloxicam 15 mg 1 x per day, Fluoxetine hcl 20 mg 1 x per day",none,none,,none,"['Chills', 'Erythema', 'Nausea', 'Oedema peripheral', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Pruritus', 'Pyrexia', 'Vomiting']",1,MODERNA, 917724,CA,33.0,F,Hives red dot rash swollen eyes and face,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PHM,Mannose D ibuprofen,,,,Penicillin Bactrim,"['Erythema', 'Eye swelling', 'Rash', 'Swelling face', 'Urticaria']",1,PFIZER\BIONTECH,IM 917725,PR,59.0,F,"I got Moderna vaccine on 12/24/2020 and had sore arm for 2 days, then 9 days later (1/1-2021) I woke up with a quarter size welt close to the injection site, which increased in size by end of day, associated with redness, heat , itching and tenderness, looks like cellulitis.On 1/2/2021 was bigger in size. It's day #11 (1/3/2021) the area is still inflamed, but it's less acute",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/01/2021,8.0,UNK,Centrum -vitamins,no,no,RhoGAM,no,"['Cellulitis', 'Erythema', 'Pain in extremity', 'Pruritus', 'Tenderness', 'Urticaria']",UNK,MODERNA,IM 917726,FL,44.0,F,"Facial swelling, orbital edema, blurred vision in right eye, red rash in neck, malaise, fatigue, and headache I took Benadryl 25mg Q6hrs on 1/1 and 1/2/21. When my vision became blurry I went to an urgent care clinic on 1/3/21",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/01/2021,3.0,PVT,"Amlodipine, Flonase, cranberry Fruit pill, multivitamin, alprazolam, trazadone, xyzal",None,Hypertension,,NKDA,"['Fatigue', 'Headache', 'Malaise', 'Orbital oedema', 'Rash', 'Rash erythematous', 'Swelling face', 'Vision blurred']",1,MODERNA,IM 917727,NY,38.0,M,"Patient with a history of thalassemia and Gilbert's disease, developed severe jaundice three days after vaccination. Had mild headache and sore arm but otherwise felt well. Had labs drawn - found to have highly elevated bilirubin (23) and LFTs in the 700s. Was admitted to the hospital and had CT showing Cholelithiasis, choledocholithiasis and minimal intrahepatic biliary ductal dilatation. Left hospital and was admitted to another facility where plan was for ERCP and cholecystectomy. Ultimately unclear if at all related to the vaccination - may be coincidental.",Not Reported,,Not Reported,Yes,,Not Reported,,12/29/2020,12/30/2020,1.0,PVT,"Folic acid, multivitamin",,"Thalassemia minor, Gilbert's disease, history of pigment gallstones, hx of splenomegaly",,None,"['Bile duct stone', 'Biliary dilatation', 'Blood bilirubin increased', 'Cholelithiasis', 'Computerised tomogram abnormal', 'Full blood count', 'Headache', 'Jaundice', 'Liver function test increased', 'Metabolic function test', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 917728,OH,55.0,F,No taste for food; lymph nodes swollen; painful teeth; fever,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/02/2021,3.0,SEN,,,DM2,,,"['Ageusia', 'Lymphadenopathy', 'Pyrexia', 'SARS-CoV-2 test negative', 'Toothache']",1,MODERNA,IM 917729,OR,65.0,F,"Ptosis left eye developed about 48 hours after vaccine, mild progressed to very noticeable currently improving",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/30/2020,2.0,PVT,"Advair, pantoprazole, montelukast, loratadine, multivitamin, fluticasone nasal spray, azelastine nasal spray",none,"asthma, GERD",,sulfa bacitracin ointment,"['Eyelid ptosis', 'Neurological examination abnormal']",1,MODERNA,IM 917731,OH,44.0,M,"Moderna COVID-19 Vaccine EUA Took vaccine at 2:45 pm Shoulder was getting sore that night before going to bed Next day woke up and shoulder was sore but felt fine. As the morning progressed, started feeling worse. By 11:00 am, reached peak severity of side effects. Side effects lasted from 11:00 am till I woke up the next morning. Woke up feeling fine except shoulder was still a little sore. Side effects were (listed by order of severity): fatigue, body aches, feeling spaced-out. Tylenol and Advil did seem to lessen those effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"pantoprazole, multivitamins and supplements",none,none,,none,"['Arthralgia', 'Fatigue', 'Feeling abnormal', 'Pain']",1,MODERNA,SYR 917732,VT,44.0,F,"Diaphoretic palms, palpitations, jitteriness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Synthroid,None,Thyroid disease,,Sulfa Methimazole Cephalosporins,"['Feeling jittery', 'Hyperhidrosis', 'Palpitations']",1,PFIZER\BIONTECH,IM 917733,OK,57.0,F,"16:40 - Moderna vaccine administered RN. 16:54 - Client reported being thirsty and having tingling face. 16:56 - Blood pressure 200/110, pulse 104 bpm, O2 sat 98% on room air. Client reports tingling face, but denies difficulty breathing, dizziness, and/or swelling of tongue. No observed hives and/or pale skin. 17:03- Blood pressure 208/108, pulse 103 bpm, O2 sat 99% on room air. Client reports tingling face, but denies difficulty breathing, dizziness, and/or swelling of tongue. No observed hives and/or pale skin. Client declined medical staff to call for medical intervention by emergency medical response. 17:10 - Blood pressure 204/108, pulse 110 bpm, O2 sat 98% on room air. Client reports tingling face, but denies difficulty breathing, dizziness, and/or swelling of tongue. No observed hives and/or pale skin. Observed flushed skin to chest. Asked client if she would be willing for husband to drive her to emergency room to be medically evaluated, client declined. 17:15 - Blood pressure 206/126. Client declined calling emergency medical response and being driven to hospital by husband for medical evaluation. Client reports being stressed out with life circumstances. Client reports she had not taken her blood pressure medication that day. Client reports having anxiety due to life circumstances and takes anxiety medication. Client reports wanting to go home, take her medication, and lay down. Recommended client take blood pressure twice daily, log readings, schedule f/u appointment with PCP in one week, and take logged readings to PCP to make sure no adjustment is needed with prescribed medication. 19:50 - F/U call to client's husband. Husband reports taking client's blood pressure at 175/101. Client reported in background that she had take her blood pressure and anxiety medications. 20:30 - Husband text reporting client's blood pressure reading at 163/94. 1/1/2021 at 10:10 - Husband text stating client took her blood pressure medication at 9:30 am and blood pressure is now reading 130/79. Husband reports client stated she no longer has facial numbness, but her arm was sore at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,Client reported during f/u call that she takes Lexapro and Memantine for Anxiety/Stress and Quinapril for HTN.,HTN Anxiety,HTN,,Codeine - Anaphylaxis,"['Flushing', 'Hypoaesthesia', 'Injection site pain', 'Paraesthesia', 'Thirst']",1,MODERNA,IM 917734,OK,64.0,M,"2 hours after injection:- Sore arm. 12 hours-99 degree temp, elevated pulse, shivers. 14 hours-100 degree temp, elevated pulse (120 bpm), chills, persistent moderate headache, achy muscles, sore back. 24 hours-98 degree temp, head ache gone, just a worn out feeling, 36 hours-back to normal other than a very sore arm at injection site and a worn out feeling.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,"Prilosec, Ezetimibe, Chlorthalidone, Iron supplement, Fish Oil supplement,",None,None,Shingles vaccine: Very sore and inflamed arm at injection site lasting several days. Age 64 at time of injections.,Penicillin,"['Back pain', 'Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Heart rate increased', 'Injection site pain', 'Myalgia', 'Pain in extremity']",1,MODERNA,IM 917735,VA,62.0,M,LEFT OCCULAR CONJUNCTIVITIS WITH DRAINAGE REQUIRING TREATMENT WITH ANTIBIOTIC AND STEROID OCCULAR DROPS FOR TEN DAYS. RESOLVED AFTER TREATMENT,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/19/2020,2.0,PVT,diltiazem180 cd daily,none,mild controlled HTN,,ultram,['Conjunctivitis'],1,PFIZER\BIONTECH,IM 917736,MT,46.0,F,Nausea Fatigue Weakness Heart palpitations,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,Thyroid medicines,None,Thyroid Allergies,,Pyridium Environment,"['Asthenia', 'Fatigue', 'Laboratory test normal', 'Nausea', 'Palpitations']",1,MODERNA,IM 917737,IN,65.0,M,"Sore arm at the site , and fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,OTH,DayQuil,None,None,,None,"['Fatigue', 'Injection site pain']",1,PFIZER\BIONTECH, 917738,DE,64.0,F,Itchy 50 cent coin size welt returned,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,01/02/2021,7.0,PVT,prozac omeprozole Premarin aspirin,none,none,,KNDA,"['Pruritus', 'Urticaria']",1,MODERNA,IM 917740,MO,41.0,M,"That night approximately 2300, started with minor chills and tiredness, 0430 with increased chills and body aches, headache, and took ibuprofen and Tylenol. Every 4-5 hours the body aches and chills came back, still taking the ibuprofen and Tylenol, napped later in the afternoon and woke up approximately 1630 feeling good. Laid in a recliner approximately 2000 and dozed off for about 30 minutes, woke up feeling worse with uncontrollably shaking chills, body aches, joint pain, fever of 101. Woke up the next day with minor body aches and joint pain. Sunday approximately 0730 had headache, joint pain flushed feeling/hot flashes/sweating, the body aches again.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Guaifenesin, Tylenol",COVID- dx 12/15/2020 with symptoms starting the day before,None,,None,"['Arthralgia', 'Chills', 'Fatigue', 'Feeling abnormal', 'Flushing', 'Headache', 'Hot flush', 'Hyperhidrosis', 'Pain', 'Pyrexia', 'Tremor']",1,MODERNA,IM 917741,CT,53.0,M,"Fatigue, headache, chills, muscle aches, difficulty sleeping- moderate enough to disrupt daily routine- felt the same as I did when I actually had covid 19",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,,Covid 19 October 26; 2020,,,,"['Chills', 'Fatigue', 'Headache', 'Insomnia', 'Loss of personal independence in daily activities', 'Myalgia']",1,MODERNA,IM 917742,NJ,52.0,F,"Fevers,-38.2., chills on the same date at 825 pm. The next day, fevers,-38.6, chills, arthralgia, headache, hands and feet were very cold like I was thrown into the snowy place that I needed 3 sheets to cover me like comforter and fleece and heater at 74-75 degrees while in the small room of my son, alone. On the 3rd day, low grade fevers-37-38.2 , persistent severe headache and muscle ache. On the 4th day, no fevers but moderate headache and muscle ache and nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,"Multivitamins(centrum), vit. C, Vit. E, Vit. B complex, fish oil, zinc, Vit. D3 and Protonix",None,None,,NKDA/NKA,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Nausea', 'Peripheral coldness', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 917743,TX,31.0,F,"Severe headache, nausea and vomiting >20x the next morning , dizziness, injection site redness, swelling, and tenderness. Stomach cramps Took zofran for vomiting. Nausea, headache, and dizziness lasted x 72 hours after injection Tylenol and Motrin also used which provided no relief",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PUB,Multivitamin,"None. COVID 10/27/2020, had negative test since then",None,,None,"['Abdominal pain upper', 'Dizziness', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Nausea', 'Vomiting']",1,MODERNA,IM 917744,CO,42.0,F,Redness and swelling at the injection site. Arm hot to touch,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,PVT,Yaz Aleve,Covid 19,None,,KNA,"['Injection site erythema', 'Injection site swelling', 'Skin warm']",1,MODERNA,IM 917745,CA,50.0,F,"S: Patient, RN from TCC/CCU came to Covid vaccine clinic on 1/3/2020 for Covid vaccine. She received vaccine at 7:23 am. Received injection on left arm. At 8:12am, she reported heaviness on left arm, tingling sensation on left 3rd and 4th fingers, and metallic taste. She denies motor weakness, sob, n/v, chest discomfort, palpitation, difficulty breathing, dizziness, headaches, blurry vision. Hx of HTN, mitral valve prolapse, asthma, migraine. Currently taking labetalol 400 mg bid, hctz/losartan 100/50 mg bid. Have not taken her BP medications this morning. She took benadryl 25 mg and tylenol 1000 mg at 6:35 am prior to coming to clinic. She is allergic to multiple medications. O: At 8:12, VS: 177/104, 97%, HR 66. Reports paresthesia to L arm, metallic taste At 8:25, VS: 157/102, 98%, HR 62. Continues to experience paresthesia and heaviness, but it has gradually improved, metallic taste resolved At 8:37, VS: 149/92, 98%, HR 64. Paresthesia and heaviness improved. AAOx 4, follows command, speech clear, lung sounds clear, heart sounds normal, normal rate and rhythm. Motor strength +5/5 bilaterally. No facial weakness/facial drooping. Subjective paresthesia on left 3rd and 4th fingers that gradually resolved. Subjective heaviness on left upper arm. No angioedema. No respiratory distress. A: Reaction to Covid-19 vaccine. P: Employee was closely observed in clinic. Provided fluids. VSS. Symptoms gradually improved. Employee was advised to closely monitor her symptoms, if she experience any worsening symptoms, she need to call 911 or go to the nearest emergency room. She states that she has epi pen and benadryl in her purse, and understand signs and symptoms to monitor for and when to use it if needed. Employee left to return home at 8:45 am in stable condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,"benadryl 25 mg, tylenol 1000 mg","history of hypertension, mitral valve prolapse, asthma","history of hypertension, mitral valve prolapse, asthma",,"Ace Inhibitors [Angiotensin-converting Enzyme Inhibitors], Bactrim [Co-trimoxazole], Fluticasone Propionate, Hydrocodone, Imitrex [Sumatriptan Succinate], nortriptyline, shellfish, zocor","['Blood pressure increased', 'Dysgeusia', 'Limb discomfort', 'Paraesthesia']",1,MODERNA,IM 917746,TN,63.0,F,I have just been fitted for a CPAPand have been using it for 11 days with no ill effects. Last night at roughly 3:15 am I woke up because I was having difficulties breathing. I had trouble on the inhale but the worse part was not being able to exhale with the CPAP on. I could only exhale through the mouth. I had to take the CPAP off so as I could breath. I also got out of bed to get in a sitting position. At this point my breathing seemed somewhat ok. About 30 minutes later I took my blood pressure and pulse. BP was 123 over 70 and my pulse was 70.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,PVT,Omeprazole 20mg Rosuvastatin 20mg Amlodipine Besylate 2.5 mg Fluticasone Cetirizine hydrochloride Garden of life raw enzymes women 50 and wiser,Sleep apnea,Asthma,,Hydrocodone Fish,"['Continuous positive airway pressure', 'Dyspnoea']",1,PFIZER\BIONTECH, 917747,IN,43.0,F,"Started the following day December 29th about 9PM having diarrhea. Diarrhea continued on December 30th. Also on December 30th my left eye began to swell. I took benadryl that evening before going to bed, but woke up the next morning December 31st with both eyes swollen. The left eye being worse and now under the eye was red and extremely itchy. Contacted employee health at hospital on December 30th and 31st. where vaccine was given and left a message detailing my side effects. Contacted my own primary dr on December 31st and was seen by Dr who believes I have had an allergic reaction to Moderna vaccine. I was prescribed predinsone and zyrtec for 5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,multi vitamin,none,history of breast cancer,,none,"['Blood immunoglobulin E', 'Diarrhoea', 'Differential white blood cell count normal', 'Eye pruritus', 'Eye swelling', 'Full blood count normal', 'Histamine release test', 'Hypersensitivity', 'Ocular hyperaemia', 'Platelet count normal', 'SARS-CoV-2 test negative', 'Tryptase']",1,MODERNA,IM 917748,FL,51.0,M,Patient stated throat tightness and flushing on head,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,PVT,,,,,,"['Flushing', 'Throat tightness']",1,MODERNA,IM 917749,OK,53.0,F,"At approximately 10:30 am, received call from (clerical at County Health Dept) stating client is on phone and she is reporting tongue swelling after receiving Moderna COVID-19 vaccine approximately one hour earlier. Staff instructed to tell client to go to emergency room for evaluation. Staff reported client stated she did not need ambulance and was okay to drive herself to the emergency room. At approximately 12:30, RN attempted to contact client at listed number, no answer, left message to call personal cell. RN contacted Hospital emergency dept. after not being able to reach client by phone. Nurse in emergency dept. stated client had not been there. Called another RN and had her request that Director of Facility (where vaccines were being administered to staff and residents) call her staff member (client) and f/u to see if she went to be medically evaluated. Director reported that client went to Urgent Med and they evaluated her. Director reported client was given Benadryl and sent home. Attempted to f/u with client a couple more times that afternoon and evening, no answer, left message to return call to personal cell. Never received call back from client. Attempted to contact client again on 1/3/21 at 11:14, no answer, left message to call personal cell. Spoke with Director via text and requested she reach out to client to have her call public health nurse . Director text client and requested she call RN with the County Health Dept. stating that nurse needed to f/u on her symptoms. Will await call back from client.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PUB,Unknown,Unknown,Unknown,,"Per Moderna pre-vaccination screening form, client marked NO on having ever had an allergic reaction (anaphylaxis) to something and needing an EpiPen or epinephrine for which she had to be taken to hospital.",['Swollen tongue'],1,MODERNA,IM 917750,CA,33.0,F,Vibration in left thigh that last all day and first half of following day,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,UNK,,,,,,['Muscle twitching'],1,PFIZER\BIONTECH,SYR 917751,NY,31.0,F,I developed shingles after vaccine. First day after vaccine developed pain then rash 2 days later,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,UNK,,,,,,"['Herpes zoster', 'Pain', 'Rash']",UNK,MODERNA,IM 917752,VA,50.0,M,"Flu-like symptoms started 12 house after receiving the vaccine. Chills, fever, joint pain, felt like all my muscles were spasming. I took Tylenol and ibuprofen, These symptoms last about 4 hours. I continued with weakness and overall feeling of weakness for the next 12 hours. Back to normal after 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,Amlodipine Zyrtec Flonase,None,Hypertension Eosinophilic Esophagitis Sports induced asthma,,None,"['Arthralgia', 'Asthenia', 'Chills', 'Influenza like illness', 'Muscle spasms', 'Pyrexia']",1,MODERNA,IM 917753,PR,47.0,F,dizziness weakness headache neck pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/28/2020,7.0,OTH,Synthesis 100mg Vit C Vit D,No,Hipothiroidism,,No,"['Asthenia', 'Dizziness', 'Headache', 'Neck pain']",1,PFIZER\BIONTECH,IM 917754,ME,38.0,F,"Tingling around the mouth, tightness in the throat, and redness on the upper chest. Benadryl 25 mg po once and observed for more than 1 hr and improved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,,None,,,"Allergic to Tylenol, Anaphylaxis to shellfish,","['Erythema', 'Paraesthesia oral', 'Throat tightness']",1,MODERNA,IM 917755,OH,33.0,M,"On 12/24 patient experienced headache, fatigue, fever of 101.5, body aches, site pain, joint pain, and nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/24/2020,1.0,PUB,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 917756,PA,31.0,F,"Developed mild redness, hives, and itching at site of injection on days 2 and 3. Symptoms completely resolved independently on days 4 and 5. On day 6, developed significant welt-like hives, intense burning and itching, and numbness/tingling of entire extremity. Also developed a non-pruritic, flat, diffuse, pinpoint rash to the trunk. Rash and itching resolved with Benadryl. Right upper extremity burning, pain, and numbness persist.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,None,None,None,,Cephalosporins,"['Burning sensation', 'Hypoaesthesia', 'Injection site erythema', 'Injection site pruritus', 'Injection site urticaria', 'Pain in extremity', 'Paraesthesia', 'Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 917757,IA,44.0,F,"11:30 am developed bad stomach cramps/ nausea. Around 10:30 pm chills. 11:30 pm fever100.5, bad body aches, headache, nausea, slight periodic numbness in hands. Next day fever gone. On day 6 and still have bad stomach cramps. Some nausea and slight headache, scratchy throat.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PUB,Mirtazapine 15 mg as needed,None,None,,None,"['Abdominal pain upper', 'Chills', 'Headache', 'Hypoaesthesia', 'Nausea', 'Pain', 'Pyrexia', 'Throat irritation']",1,MODERNA,SYR 917759,ME,35.0,F,"Tingling sensation in the face, tightness in the throat, and redness on the arms and chest Benadryl 25 mg po once given",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,,COVID-19 Infection on 11/25/20,,,Allergic to Moxifloxacin,"['Erythema', 'Paraesthesia', 'Throat tightness']",1,MODERNA,IM 917760,MI,34.0,F,"I had an allergic reaction within ten minutes and was taken to the emergency room with throat pain, itching in the throat and mouth and a swollen uvula. I was given multiple doses of Benadryl and steroids. The next day I developed a temperature of 102 degrees and had a severe headache, nausea, and body aches. The headache and fatigue are still present now 4 days later.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,None,None,None,,"Penicillin, tree nuts, sulfa drugs","['Body temperature increased', 'Enlarged uvula', 'Fatigue', 'Headache', 'Hypersensitivity', 'Nausea', 'Oral pruritus', 'Oropharyngeal pain', 'Pain', 'Throat irritation']",1,PFIZER\BIONTECH,SYR 917761,NJ,31.0,M,"Experienced body aches, fatigue, scratchy throat. No treatment. After going back to bed that morning and sleeping for approximately 2 hours symptoms started to relieve themselves",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/01/2021,4.0,SEN,"Vyvanse, claritin prilosec",none,none,,none,"['Fatigue', 'Pain', 'Throat irritation']",1,PFIZER\BIONTECH,IM 917762,CA,33.0,M,Left supraclavicular and left anterior cervical lymphadenopathy mildly tender and mobile. Started 6 days after vaccine to the left deltoid and persisting,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/29/2020,6.0,PVT,Pantoprazole 20 mg Vitamin D 1000 IU,None,GERD,,Shellfish,"['Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 917763,CA,28.0,M,9:38 am -8-10 minutes after vaccine injection patient felt nausea and dry heaving 9:42 am - patient evaluated by by EMS BP 142/100 Pulse 120 9:48 am patient transported to ER.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PUB,Lisinopril,na,Hypertension,,Na,"['Nausea', 'Retching']",1,PFIZER\BIONTECH,IM 917764,TX,32.0,F,"Chest tightness, shivers, fever, headaches Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,WRK,Tylneol,No illnesses,,,No allergies,"['Chest discomfort', 'Chills', 'Fatigue', 'Headache', 'Pyrexia']",1,MODERNA,IM 917765,PR,63.0,F,"On 01/01/2021 I began to feel excessive itching, redness and swelling in the vaccination area. It appears to be cellulite. Also I present mild daily headache from that day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/01/2021,6.0,PUB,none,none,asthma,,allergic to sea food,"['Headache', 'Injection site erythema', 'Injection site pruritus', 'Vaccination site swelling']",1,MODERNA,IM 917767,PA,74.0,M,"Started feeling light headed 15 to 20 minutes after getting the vaccine.Had tachycardia for 2 to 3 minutes.Lightheadedness lasted about 10 minutes.Next morning woke up with true vertigo .Lasted few minutes.That night mild vertigo returned, mostly positional.Ever since mild light headedness.Have to sleep in a recliner.Vomited once, but continue to have mild nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,SEN,"Flomax ,Ecotin,Crestor",Tinnitis left ear,BPH,,None,"['Dizziness', 'Nausea', 'Tachycardia', 'Vertigo', 'Vomiting']",1,PFIZER\BIONTECH,SC 917768,FL,34.0,F,"About 12 hours after the vaccine, I started developing chills and joint pain. That night, I developed fevers that persisted for about 24h (spiked about 5 separate times - highest fever was 102). Then, on the third night after the vaccine (about 60 hours post vaccine), I had two separate episodes of night sweats (clothes were drenched, no fever). Later that night I had a bowel movement with bright red blood. I then went to an urgent care where they drew labs, send a Covid swab, ordered stool studies, and ordered a CT abdomen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Arthralgia', 'C-reactive protein', 'Chills', 'Computerised tomogram abdomen', 'Culture stool', 'Full blood count', 'Haematochezia', 'Hyperhidrosis', 'Metabolic function test', 'Night sweats', 'Pyrexia', 'Red blood cell sedimentation rate', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,IM 917769,MO,59.0,F,At 2 am woke to severe chills and hyperventilating. Took 45 minutes for everything to stop. (very scary) At 6:30 am began running a temp of 101.1. Starting taking tylenol. Fever never did go away. Still had fever at 8 pm when I went to bed. Woke up next morning and was fine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,Synthroid cozar claritan,none,none,,penicillin,"['Chills', 'Fear', 'Hyperventilation', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917770,CA,62.0,M,"I have constant tinnitus since about a day after receiving the first dose to the Covid-19 vaccine. It got worse over the New Year's weekend, and now seems to be stabilized as a constant ringing. I will be making an appointment this coming week to have it investigated, but wanted to get the preliminary information to you. I have experienced a much lesser degree of tinnitus in the past, always a momentary transient event, not nearly as loud as I am currently experiencing.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PUB,"Multivitamin, fish oil, garlic, turmeric, vitamin K, vitamin D, vitamin C, magnesium.",None,None,,None,['Tinnitus'],1,PFIZER\BIONTECH,IM 917771,IL,29.0,F,"Numbness to right side of upper body, arm, and face. Clammy, hot flashes, severe headache. Throat was swelling shut. Could feel it closing each time I swallowed. Emergency room gave steroids, Benadryl, and a coating for stomach.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/02/2021,2.0,PUB,Adderall,None,Vitamin D deficiency,,None,"['Cold sweat', 'Computerised tomogram', 'Dysphagia', 'Headache', 'Hot flush', 'Hypoaesthesia', 'Pharyngeal swelling', 'Throat tightness']",1,MODERNA,SYR 917772,AL,42.0,F,"Fatigue, muscle aches and fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,None,None,"Kidney stones, DVT",,"Cipro, keflex Shrimps","['Fatigue', 'Myalgia', 'Pyrexia']",UNK,MODERNA,IM 917773,TX,64.0,F,Moderna COVID-19 Vaccine EUA Soreness in arm around injection site for two days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,UNK,,,Type 1 Diabetes,,,['Injection site pain'],1,MODERNA,IM 917774,,40.0,F,SOB and tachycardia,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Dyspnoea', 'Tachycardia']",1,MODERNA,IM 917775,CA,35.0,F,"12/23/20: within 2 minutes of receiving the vaccine I felt pulsing in my left wrist and weakness in my left hand, within 30 minutes my left ear felt like it needed to pop, I had the normal/expected side effects for the first 1-2 days (very sore arm, headache, achy, fatigue, mild joint pain) 12/24/20: weakness/numbness/cold feeling in my left lower leg and foot, fullness in left ear continued 12/27/20: same sx as 12/24, plus weakness/numbness in left forearm, pinky and ring finger 12/28/20: same sx as above, plus fullness in R earned weakness/numbness in right forearm, pinky, and ring finger 12/30/20: same sx as above, plus weakness/numbness on the left side of my face, no drooping 12/31/20: same sx as above, now with weakness/numbness/cold sensations on both sides of face (although only one side at a time), in both legs, both arms down into pinky and ring fingers (weakness noticed when typing and writing). Both ears still with fullness feeling (only one side at a time). I can still walk/run, these symptoms are still present as of today 1/3/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,Levothyroxine 50 mcg daily,None,Subclinical hypothyroidism,,Local reaction to vaginal estrace cream (likely allergic to polyprene glycol ingredient),"['Arthralgia', 'Ear discomfort', 'Facial paresis', 'Fatigue', 'Feeling cold', 'Headache', 'Hypoaesthesia', 'Muscular weakness', 'Pain', 'Pain in extremity', 'Peripheral coldness', 'Pulse abnormal']",1,PFIZER\BIONTECH,IM 917777,TX,47.0,F,Moderna COVID-19 Vaccine EUA I am currently experience tenderness in my lymph nodes under my left arm (injection arm). I did experience other side effects as well but this one more intrusive. I experienced soreness at the injection site for a few days and a headache.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,01/02/2021,32.0,OTH,No,No,No,,No,"['Axillary pain', 'Headache', 'Injection site pain']",1,MODERNA,UN 917778,,29.0,F,"1121 Patient started feeling hot, face red, throat feeling dry and tight. Vital signs: Blood pressure 122/78 Heart rate 88 SATS 99% ON ROOM AIR. Patient was given Benadryl 25 mg by mouth. After about 15 minutes after administration, patient noted her ""hot flash"" had dissipated and her ""funny feeling in throat"" had minimized. She denied difficulty breathing or swallowing. Patient was discharged at 12:00. At 12:15, patient returned appearing slightly flushed and complaining of feeling warm again. While accompanying patient to Convenient Care, patient noted her throat ""felt funny"" and had to clear her throat to speak. Patient was transferred to convenient care nurse at 12:20",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,PVT,,,,,,"['Dry throat', 'Erythema', 'Feeling hot', 'Flushing', 'Hot flush', 'Oropharyngeal discomfort', 'Throat clearing', 'Throat tightness']",1,MODERNA,IM 917779,OH,38.0,M,"Moderna COVID-19 Vaccine EUA Lymphadenopathy, axillary node on injection side. Palpable and painful, approximately 3-5 cm in diameter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/31/2020,5.0,OTH,,,,,,"['Lymph node palpable', 'Lymphadenopathy']",1,MODERNA,IM 917780,AZ,25.0,F,Sore arm. Sore throat. Back ache. Headache. Chills in feet,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,SEN,,,,,,"['Back pain', 'Chills', 'Headache', 'Oropharyngeal pain', 'Pain in extremity']",UNK,MODERNA,SYR 917781,NJ,50.0,F,Severe headache and very tired.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,,None,None,,None,"['Fatigue', 'Headache']",1,MODERNA,SYR 917782,NJ,65.0,F,"Temp. 102, chills, body aches, headache, extreme fatigue; slept most of the day on the 1st; still w/body aches, less fatigue, decreased headache, temp 100 on 01/02; back to normal by 2:00 on 01/02",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,Paroxitine HCL,,,,,"['Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Hypersomnia', 'Pain']",1,PFIZER\BIONTECH,SYR 917783,KY,61.0,F,"To preface, I'm a physician (pediatrician). I developed a swollen, indurated, erythematous itchy area approx 3x5 cm at the site of the vaccine the evening I received the vaccine, persisted a couple days, finally resolved leaving very slight induration behind. EIGHT days after vaccine (on Dec 31), I received my regular allergy injections (one in each arm, below site of Moderna vaccine), that evening the site of the Moderna vaccine again became indurated, swollen, itchy/painful, red (redness was more widespread than the original reaction, I have pictures if needed), this lasted for about 72 hours, again leaving a very slightly indurated area behind. Plan to do both allergy shots in the OTHER arm this week.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PUB,"Famotidine, QVar, Advil, Nasacort, Melatonin, Calcium, Vitamin D3, Allergy injections for seasonal and cat allergies",,"Asthma, GERD, obesity","FluMIst, Approximately 2010, asthma attack, age 51","Sulfa, Fluoroscein","['Injection site pruritus', 'Vaccination site erythema', 'Vaccination site induration', 'Vaccination site pain', 'Vaccination site swelling']",1,MODERNA,IM 917784,TX,79.0,M,"Pt had vaccination at city site. Waitied 15 min after shot and was cleared to go. Reported to wife that he was very thristy, so they stopped at a convenience store on the way home. While there, he felt worse and asked to go to the Emergency room. They chose Methodist to enter. Pt went to triage and while at triage, had syncopal episode, then full arrest. After short course of CPR and defib, he had ROSC. Was taken to cath lab for intervention (stents) and is now in ICU.",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/02/2021,01/02/2021,0.0,OTH,None,None,None,,None,"['Brain natriuretic peptide normal', 'Cardiac arrest', 'Cardioversion', 'Coronary arterial stent insertion', 'Haematocrit decreased', 'Haemoglobin normal', 'Intensive care', 'Red blood cell count decreased', 'Resuscitation', 'Syncope', 'Thirst', 'Troponin', 'White blood cell count increased']",UNK,MODERNA, 917785,NY,43.0,M,"member was vaccinated on 12/29 - 1-2 hours later developed injection site soreness/swelling/chills/fatigue/intermittent headaches/""head cold like symptoms"" - yesterday evening developed R facial swelling including to upper lip and numbness in face - is able to smile and use muscles normally no facial dropping but face is still puffy today after 50 mg Benadryl. Member has R inner ear itching but denies throat tightness/difficulty breathing",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,multivitamin,none reported,none reported,,has had allergic reaction in past to medications and a vaccine,"['Chills', 'Ear pruritus', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Injection site pain', 'Injection site swelling', 'Lip swelling', 'Nasopharyngitis', 'Swelling face']",1,MODERNA,IM 917786,CA,53.0,F,"Left arm cellulitis, redness with induration at injection site started the day after injection. Chills and sleepy. Given Rocephin IM 12/30/2020. Prescribed clindamycin 300mg 2 tab q8 for 7 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,WRK,D3 vitamin supplement B12 Centrum MVI,Cold sore on lip one month ago,none,Redness at injection site after flu vaccine in September 2020,"PCN, Sulfa, Bactrim, oxycodone, iodine, latex, codeine","['Cellulitis', 'Chills', 'Injection site erythema', 'Injection site induration', 'Somnolence']",1,MODERNA,IM 917787,FL,77.0,F,"Starting same day sore arm, by Tuesday late/Wednesday sore shoulder and knife like pains under left shoulder blade. Pain bad enough Wednesday night/Thursday early morning to contact Dr. Thursday. He determined my pain was muscle pain. Suggested Aleve (as Tylenol and Advil weren't working) and heating pad (which I had used on Wednesday during day). Aleve helped a lot. Pain by today (Sunday) is minimal but still some minimal discomfort.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,12/27/2020,0.0,PVT,"HBP meds, HCh med, Omeprazole, Restasis, Premarin cream, low-dose aspirin, fish oil, calcium, D3",none,HBP,,"Phenothyazines, penicillin, epi, lidocaine patch","['Arthralgia', 'Myalgia', 'Pain in extremity']",UNK,MODERNA,IM 917788,FL,75.0,M,"Moderna COVID-19 Vaccine EUA I had the Qovid-19 virus back in March of 2020 and symptoms such as fever, chills, fatigue, muscle and body aches. approximately 5-6 hours after receiving the vaccine i felt most of those same symptoms but on a much lesser scale. all of those symptoms went away after 36 hours. I spoke to some of my friends that took the vaccine the same day i took it and in general most of the friends that previously had the virus had similiar symptions again while those that never had the virus did not have any reraction to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,UNK,,,,,,"['Chills', 'Fatigue', 'Myalgia', 'Pain', 'Pyrexia']",1,MODERNA,IM 917789,IN,45.0,F,"Severe vertigo began at 3:00 PM on 12/31/2020. Vomiting lasting approx. 9 hours (8 episodes). Unable to open eyes due to vertigo, vasovagal upon standing lasting until approx. 3:00 pm 1/2/2021. Diarrhea began approx. 8:00 pm 1/1/2021 with episodes each time after trying to eat 4 episodes. Headache lasted 3 days. Today on 1/3/2021 I have been able to keep down soup. Eyes feel tired, minimal vertigo upon moving head. No further diarrhea, vomiting.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,sertraline 100 mg qd; protonix 40 mg qd,None,HX of Migraines,,NKA,"['Diarrhoea', 'Fatigue', 'Headache', 'Presyncope', 'Vertigo', 'Vomiting']",UNK,PFIZER\BIONTECH,SYR 917790,AR,90.0,F,"At the time of vaccination, there was an outbreak of residents who had already tested positive for COVID 19 at the nursing home where patient was a resident. About a week later, patient tested positive for COVID 19. She had a number of chronic, underlying health conditions. The vaccine did not have enough time to prevent COVID 19. There is no evidence that the vaccination caused patient's death. It simply didn't have time to save her life.",Yes,01/03/2021,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/29/2020,7.0,SEN,"Torsemide, Trazadone, Amitizide, Morphine Sulfate, Fentanyl, Carbidoba-Levodopa, Prednisone, Potassium Chloride, Escalitapram, Incruse Ellipta, Mirtazipane, Clonazepam, Levothyroxine",Patient was a resident of a long term care facility and had numerous chronic conditions prior to vaccination.,"Thyroid disease, chronic elderly conditions.",,None,"['COVID-19', 'Death', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,MODERNA,IM 917791,NY,34.0,F,Arm redness and sore,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,None,None,None,,None,"['Erythema', 'Pain in extremity']",1,MODERNA,IM 917792,FL,56.0,M,"BAD HEAD ACHE, STUFFYNESS, CHEST CONGEST. TIREDNESS, GRUMPY AS HELL",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,PUB,VITS AND MOTRIN,,,,MSG,"['Fatigue', 'Headache', 'Irritability', 'Nasal congestion', 'Respiratory tract congestion']",1,MODERNA,IM 917793,AR,78.0,F,"Prior to the administration of the COVID 19 vaccine, the nursing home had an outbreak of COVID-19. Patient was vaccinated and about a week later she tested positive for COVID-19. She had underlying thyroid and diabetes disease. She died as a result of COVID-19 and her underlying health conditions and not as a result of the vaccine.",Yes,01/02/2021,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/29/2020,7.0,SEN,"Metoprolol-Tartrate, Latanoprost, Glipizide, Pravastatin, Metformin, Benaprezil, Potassium-Chloride, Levothyroxine","Diabetes, Thyroid disease","Diabetes, Thyroid Disease",,None,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",1,MODERNA,IM 917794,GA,40.0,F,"Patient received Moderna vaccine on 12/23/20 at approximately 1530. No adverse events observed immediately following injection. Approximately 12 hours later (12/24/2020 @ 0300) patient developed fever, chills, body aches, fatigue and headache that last for approximately 24 hours. On 12/24/2020 @ 1200 patient experienced near syncopal episode. On 12/24/20 @ 1500 patient developed hive on b/l legs and arms. Symptoms treated with motrin and benadryl. All symptoms resolved by 12/25/2020",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,"Imitrex 100mg PRN migraine, Loestrin 1.0/30, multivitamin",,migraines,,"Sudafed, Sulfa drug","['Chills', 'Fatigue', 'Headache', 'Pain', 'Presyncope', 'Pyrexia', 'Urticaria']",1,MODERNA,IM 917795,CT,24.0,F,"Rash, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/29/2020,1.0,WRK,Birth control,,,,"Pineapple, poison ivy","['Pyrexia', 'Rash']",1,MODERNA,IM 917796,HI,59.0,F,"Within the night I felt pain on the insde area of the FOREARM of the injected arm. The pain was something I have never felt before. A pain like I had been hit on the arm. The pain was not intense ALL night and it did not keep me awake all night. The following day I felt the pain again, same place, but only for a half hour or so. I have not felt that pain since, but there remains a swelling and hard lump in the place I felt the pain, with a slight pain if pressed. The lump and swelling remains constant. No worse, not sure if any better either. No redness, and not hot to the touch. No other swelling anywhere else. Other reactions are just a slight overall sluggish feeling, that is better after sleep.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,??Morning pills Allopurinol 300 mg tab Metoprolol er succinate 100 mg tabs Losartan Potassium 100 mg tab Cetirizine Hydrochlororide 10 mg. -1 daily [antihistamine] *Guaifenesin 400 mg/10 mg Phenylephrine HCI� [expectorant] -1 daily Tylenol,"Artritis, High blood pressure.","Artritis, High blood pressure, allergies to the things listed.",,"Bee stings, poison ivy, seasonal allergies. Took allergic test on arms, had a reacation to everything, including the saline solution control. I can have adverse reactions being congested when ocean swimming without a nose plug.","['Induration', 'Limb mass', 'Pain in extremity', 'Peripheral swelling', 'Sluggishness', 'Tenderness']",1,MODERNA,IM 917797,IN,43.0,F,Swelling and redness at site of vaccine. Entire muscle of left arm swollen around injection site for 4 days. Painful to touch and hot. Increased tiredness within first 24 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Synthroid Trintillix Vitamin C Zinc Vitamin D,none,none,,no,"['Fatigue', 'Injection site reaction', 'Skin warm', 'Tenderness', 'Vaccination site erythema', 'Vaccination site swelling']",1,PFIZER\BIONTECH,IM 917798,CT,49.0,F,"Flu like symptoms, body aches & pains, chills, headache, soreness at injection site., tiredness all symptoms started 24 hours after I received the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,no,no,no,,"PCN, Dust mites and tree pollen","['Chills', 'Fatigue', 'Headache', 'Influenza like illness', 'Injection site pain', 'Pain']",1,MODERNA,SYR 917799,FL,46.0,F,"Within an hour and a half after vaccination my skin was flush and red and I developed hives. I work at this facility and was sent to the ER where I was monitored for two hours and received IV Benadryl, solumedrol, and Pepcid. The redness was gone within an hour and the hives disappeared after having to take an additional 25mg Benadryl pill after 6 hours. The next day I experienced fatigue, severe muscle pain, chills and this continued for an additional 2 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,none,none,none,,none,"['Chills', 'Erythema', 'Fatigue', 'Flushing', 'Myalgia', 'Urticaria']",1,MODERNA,IM 917801,TX,33.0,F,"Severe migraine, nausea, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,UNK,"Xeljanz, methotrexate, plaquenil, magnesium, wellbutrin xl, sertraline, topiramate, buspirone, nexium, pirmella, folic acid, leucovorin, gabapentin, metaxolone",,"IBS, anxiety, rheumatoid arthritis, chiari malformation 1 with migraines",,"Cipro, chlorhexadine, cefdinir, adhesives","['Condition aggravated', 'Dizziness', 'Migraine', 'Nausea']",1,MODERNA,IM 917802,MD,32.0,F,"Moderna COVID?19 Vaccine EUA -at approximately 2:30pm arm soreness began and lasted until 1pm on 1/3 -at approximately 9:30pm a fever of 101.2 occurred, sweats, chills, extreme fatigue began and lasted until approximately 10am on 1/2",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,WRK,None,None,None,,Tramadol,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Pain in extremity', 'Pyrexia']",1,MODERNA, 917803,AL,31.0,F,"approx 6 minutes after receiving vaccine to Left deltoid IM site: marked tachycardia HR 180 with associated dizziness, nausea, hypotension and subsequent severe lethargy and feeling of syncope. placed on stretcher at hospital facility and ultimately fell asleep for unknown amount of time. After waking approx 2 hours later majority of severe symptoms subsided but residual tachycardia of 120s and orthostatic hypotension throughout the day for next 16 hours. associated dry flushed skin of face and dry itchy eyes throughout day as well",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,enskyce birth control methylphenidate 20mg ER,Leep Surgical procedure with general anesthesia one week prior to vaccination,Asthma Meniere's disease,,none,"['Dizziness', 'Dry eye', 'Dry skin', 'Eye pruritus', 'Flushing', 'Hypotension', 'Lethargy', 'Nausea', 'Orthostatic hypotension', 'Presyncope', 'Tachycardia']",1,MODERNA,IM 917804,IL,21.0,F,"Dizzy, fainting, numbness on right leg/ face, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/27/2020,1.0,PVT,No,No,No,,No,"['Dizziness', 'Hypoaesthesia', 'Nausea', 'Syncope']",1,PFIZER\BIONTECH,SYR 917805,NY,59.0,F,"Lightheaded,vertigo, severe shaking, cold extremeties, Increased respirations from 16 to 34 within minutes of having the vaccine. Nausea, Increased blood pressure and pulse rate. EKG was normal sinus rhythm. Tounge felt heavy and thick.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,,,Asthma,flu,"Allergy to Sulfa drugs, wasps, cats, grass,pollen and dust mites","['Blood pressure increased', 'Dizziness', 'Electrocardiogram normal', 'Heart rate increased', 'Nausea', 'Paraesthesia oral', 'Peripheral coldness', 'Respiratory rate increased', 'Tongue disorder', 'Tremor', 'Vertigo']",UNK,MODERNA,IM 917806,OH,44.0,F,"numb pockets on face, a little swelling of tongue and a little tired/flushed",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,SEN,patient has allergy to penicillin; patient started feeling numbness in the face and tongue started to swell; patient stated that she has chronically elevated epstein barbaric levels; 25mg of benadryl was given; patient also takes 25mg ateno,increased levels of epstein barbaric,high blood pressure...treated with 25mg atenolol,,penicillin,"['Fatigue', 'Flushing', 'Hypoaesthesia', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 917807,MI,32.0,F,"Bruise, swelling, pain at injection site immediately following administration. Fatigue starting 12 hours after Muscle aches and joint pain 24 hours after",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,Junel Fe Lexapro,None,None,,None,"['Arthralgia', 'Fatigue', 'Immediate post-injection reaction', 'Injection site bruising', 'Injection site pain', 'Injection site swelling', 'Myalgia']",1,PFIZER\BIONTECH,IM 917808,MI,56.0,F,SEVERE HIVES FROM HEAD TO TOE LASTING APPROXIMATELY 21 HOURS I TOOK BENADRYL MULTIPLE DOSES,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Lisinopril buproprion singulair reglan doxepin Zyrtec dulera atenolol ester C echinacea multivitamin,NONE,ASTHMA HYPERTENSION,XOLAIR 10/25/2019,ALMONDS PERCH CAT DANDER(HIGHLY ALLERGIC) DUST MITES BACTRIM KEFLEX ULTRAM TORADOL BIAXIN CLINDAMYCIN CARDIZEM DOSYCYCLINE CLARITHROMYCIN AUGMENTIN,['Urticaria'],1,PFIZER\BIONTECH,IM 917809,TN,55.0,M,HEAD ACHE AND LOW GRADE FEVER WITHIN 24 HOURS OF VACCINATION. ORAL TEMP 101.5 F. I ALSO DEVELOPED A PRODUCTIVE COUGH AND STUFFED SINUSES,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,OTH,,COVID-19 ON 11/19/2020,,,,"['Body temperature increased', 'Headache', 'Productive cough', 'Pyrexia', 'Sinus disorder']",1,MODERNA,IM 917810,CO,46.0,F,"On 1/1/21 mid morning developed left arm ache that progressed into a deep bone ache/pain along full arm shoulder to wrist. On 1/2/21 pain and large hard swollen area at injection site, area approximately size of a tennis ball, painful with increased pain on movement. Mild flush to area, pink and warm to touch, with occasional stinging sensation. On 1/3/21 still swollen, less firm, still painful with stinging/burning sensation at times, darker redness approximately size of my hand, hot to touch, area of white in middle where injection was given.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/01/2021,6.0,PVT,"Apri birth control, Neurontin, Tylenol","Sinus Infection in the month prior, resolved and off antibiotics and nasal sprays prior to vaccine","Migraines, PCOS, Raynaud's, Mild mitral valve regurgitation",,"Codeine, Sulfa, Latex, Plastic tape","['Arthralgia', 'Bone pain', 'Injection site discolouration', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Pain in extremity']",1,MODERNA,IM 917811,,25.0,F,Slight soreness at site of injection (left deltoid),Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,UNK,,,,,,['Injection site pain'],UNK,MODERNA,IM 917812,CA,29.0,F,Left hip pain for 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,"OTC biotin, zinc and vitamin C",None,None,,None,['Arthralgia'],1,PFIZER\BIONTECH,IM 917813,OH,43.0,F,"Irregular heartbeat and hives 10 minutes after receiving the injection. Treated with Benadryl. Resolved 8 hours later. Pain and swelling at injection site, chills, muscle and joint pain, headache and fatigue. Treated with Ibuprofen. Resolved 24 hours later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Ocella Pantoprazole,None,Had Covid infection 11/14/2020,,None,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Heart rate irregular', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Urticaria']",1,MODERNA,IM 917814,,37.0,F,mild tingling sensation of left arm (injection site=left deltoid).,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,UNK,,,,,,['Paraesthesia'],UNK,MODERNA,IM 917815,OH,50.0,F,"upset stomach, headache, neck ache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/02/2021,2.0,OTH,"Gapapentin 300mg once daily, Simvastatin 40mg daily, atenolol 25mg daily omeprazole 40mg daily allegra 24",,,,sulfa,"['Abdominal discomfort', 'Headache', 'Neck pain']",UNK,MODERNA,IM 917816,,52.0,M,Slight tenderness at site of injection (left deltoid),Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,UNK,,,,,,['Injection site pain'],UNK,MODERNA,IM 917817,CA,42.0,F,"11:42 am patient felt dizzy and palpitations 10-12 minutes after receiving vaccine. 11:47 am patient evaluated by EMS BP 168/110, Pulse 120, EKG done. patient reporting feeling better but wishes to to seen in ED. 11:54 am patient transported to hospital by EMS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PUB,none,none,none,,shrimp,"['Dizziness', 'Hypertension', 'Palpitations', 'Tachycardia']",1,PFIZER\BIONTECH,IM 917818,TN,58.0,F,"Itching on various areas of body with hives and welts, redness. Took 50 mg Benadryl, 12 mg methylprednisolone, and applied hydrocortisone. Had to reside after 4-5 hrs, and again the next morning. Went to urgent care clinic and received 60 mg depo-prednisolone and went home and took more Benadryl and applied more hydrocortisone cream. Rash all over the body.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,PUB,Amlodipine Fosinopril hydrochlorothiazide metoprolol desloratadine atorvastatin monteleukast Benadryl stool softener meloxicam Tylenol super B complex with c and zinc turmeric curcumin d3 potassium magnesium b6 chromium picolinatekeraviati,"Ear infection, day 9 of antibiotic",Hypertension osteoarthritis osteopenia,,Sulfa lisinopril,"['Erythema', 'Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 917819,,43.0,M,Slight/mild soreness at site of injection (left deltoid),Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,UNK,,,,,,['Injection site pain'],UNK,MODERNA,IM 917820,VT,39.0,F,"After vaccine administered, c/o being lightheaded, dizziness, neck heavy, jaw numbness. Pulse 90-130. Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,WRK,,,,,,"['Chills', 'Dizziness', 'Hypoaesthesia', 'Musculoskeletal discomfort']",1,MODERNA,IM 917821,OH,37.0,F,"Vaccine site had localized reaction that started about 12 hours post vaccine and intensified about Day 2 after vaccine after which subsided and redness/swelling went away. On Day 7 noticed small amount of bruising at vaccine site. Day 8 initial area that was involved in localized reaction reappeared redder, bigger and more demarcated than originally. Contacted FDA and Moderna to report reaction and see if this was a known reaction. Submitted images to FDA and Moderna for review. Showed physicians I work with in the ED as well and we watched it for progression to r/o cellulitis but the next day reaction very reduced and today is back to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/01/2021,8.0,PVT,"Levothyroxine, various OTC supplements",Hypothyroidism,Hashimoto's thyroiditis Rosacea,,Latex - dermatitis,"['Vaccination site bruising', 'Vaccination site reaction', 'Vaccination site swelling']",1,MODERNA,IM 917822,NE,72.0,M,"Severe upper truck muscular pain, both front and back. Can hardly turn or reach for things. Getting progressively worse. Also arthritic pain in both my 1st IP joints bilaterally, unable to grasp to open packages or uncap bottles. Have had neither before.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/28/2020,5.0,PVT,Centrum Vitamin daily,none,hypothyroidism,,"Sulfa, flouroquinolones","['Arthralgia', 'Mobility decreased', 'Motor dysfunction', 'Myalgia']",1,MODERNA,IM 917823,PA,52.0,F,"About 5 mins after vaccine was received patient started wheezing, felt like her throat was closing. Difficulty breathing",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,WRK,,Lung disease OSA Asthma Diabetes,Lung disease OSA Asthma Diabetes,,"Xolair, mulch, candles, seasonal Anaphylaxis","['Dyspnoea', 'Oropharyngeal discomfort', 'Wheezing']",1,PFIZER\BIONTECH,IM 917824,WA,38.0,F,"Patient had shortness of breath, slight throat swelling, arm swelling, and increased heart rate",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,SEN,Benadryl 25 mg: 1 tablet taken after reaction started,None,None,,Latex,"['Dyspnoea', 'Heart rate increased', 'Peripheral swelling', 'Pharyngeal swelling']",1,PFIZER\BIONTECH,IM 917825,CA,67.0,M,"I became very fatigued , no energy for daily tasks. I developed a non productive cough, moderate headache, and low grade fever. now my nose is congested. I feel alittle stronger 18 hrs. later. But I called in sick tonight to work nights as a night RN, on a COVID unit. I have been working with COVID Patients after getting the first of two Moderna vaccines.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,OTH,None,None,"HTN, Sleep Apnea",,None,"['Asthenia', 'Cough', 'Exposure to SARS-CoV-2', 'Fatigue', 'Headache', 'Impaired work ability', 'Nasal congestion', 'Pyrexia', 'SARS-CoV-2 test negative']",UNK,MODERNA,IM 917826,NC,22.0,F,"Patient was monitored 15 minutes after giving 1st COVID vaccine. Once she returned to the worksite approximately 30 minutes after her vaccine was given, she experienced some flushing and severe sweating. Patient was taken to the nearest ED on 12-31-20 @ 5:00pm and per patient stated that ED doctor said it could be a reaction to the COVID vaccine. On 1-1-21, patient started experiencing low grade fever, body aches and a major headache. Patient was told she can take Tylenol OTC to help with this. Patient stated on 1-2-21, she started experiencing sore throat and a metallic taste in her mouth. Patient was told she needed to go see her doctor as soon as she could to follow up with this. On 1-3-21, patient still complained of sore throat and lower back pain. Patient was advised to go to nearest Urgent care if possible. Patient stated that she was going to go to a local urgent care today and she was told to follow up with Public Health after she was seen at the urgent care.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PUB,UNKNOWN,NONE,NONE,Flu vaccine in the past,NKDA,"['Back pain', 'Dysgeusia', 'Flushing', 'Headache', 'Hyperhidrosis', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917827,IL,38.0,M,"I started getting a Migraine , but then in the middle of the night I woke up with severe Lower Back Pain , Joint pain in my shoulders , elbows , and hands bilaterally. Currently My fever is running 100.5-101 F and that?s with taking Tylenol . I still have constant severe low back pain and fatigue . I just feel sick .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,OTH,"Atenolol 50 mg , Ativan 2 mg",November 14th tested positive and was sick with covid-19 for 3 .5 weeks .,No,,No,"['Arthralgia', 'Back pain', 'Fatigue', 'Feeding disorder', 'Migraine', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 917829,CA,64.0,F,Bells Palsy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/28/2020,1.0,PVT,"Metformin, losartan","Diabetes, high blood pressure","Diabetes, high bp",,None,['Facial paralysis'],1,MODERNA,SYR 917830,CA,53.0,M,"Chills, slight fever, dizziness, and cough since 01/02/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,OTH,Hydrochorothiazide,None,Meineres,,Penicillin,"['Chills', 'Cough', 'Dizziness', 'Pyrexia']",1,MODERNA,SYR 917831,,65.0,M,Received vaccine on 12/28/2020 and c/o jitteriness on 12/29/2020 and dizziness with jitteriness on 12/30/2020. BP 152/83 HR 78. States he felt like he was floating when walking to his car this morning,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/29/2020,1.0,PVT,,,,,,"['Feeling abnormal', 'Feeling jittery']",1,PFIZER\BIONTECH,IM 917832,PA,31.0,F,"Two days after receiving first dose of Pfizer COVID vaccine started feeling generally unwell. On the third day, started feeling progressively worse: dizziness upon standing and while standing (to the point I thought I would fall over) nausea, dry heaving, headache bordering on migraine, abdominal pain and a short period of appetite loss. Today (fourth day post shot) I called out of work and feel as if I?m on a tilt table while laying down, and will feel dizzy and nauseated immediately upon standing up. This is is spite of staying hydrated and eating a bland diet in order to not upset my stomach.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,"Topamax, Zoloft, lithium, klonopin, diflucan, Zofran",,"Epilepsy, bipolar II disorder",,"Ragweed, pollen, cucumber, melon, banana, ethosuximide, briviteracetam","['Abdominal pain', 'Balance disorder', 'Decreased appetite', 'Dizziness postural', 'Headache', 'Impaired work ability', 'Malaise', 'Nausea', 'Retching']",1,PFIZER\BIONTECH,SYR 917833,,25.0,M,"sore throat, fatigue and abdominal pain",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/30/2020,8.0,PVT,"adderall, flexeril, flonase, metformin XR 500 mg 1 daily, trazodone",,"T2DM, ADHD",,Hives to penicillins and cephalosporins,"['Abdominal pain', 'Fatigue', 'Oropharyngeal pain']",1,PFIZER\BIONTECH,IM 917834,NJ,48.0,F,"1 week after receiving dose 1 area is hard, warm to touch and itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,01/02/2021,7.0,WRK,No,No,No,,No,"['Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,PFIZER\BIONTECH, 917835,MN,18.0,M,"Tactile fever ,arm pain, headache and malaise in 24 hrs following injection Next day generalized achiness ,retrosternal chest pain and bilateral forearm tingly pain similar to Nov 2019 and went to Hospital UC,CXR and EKG normal but with short PR interval on EKG ,elevated troponin 3.5 Transferred to hospital troponin 12.1 ng/ml IVIG given SARS IGG positive on admission PCR negative",Not Reported,,Yes,Yes,3.0,Not Reported,U,12/30/2020,12/31/2020,1.0,SEN,None,"COVID 19 Positive sept 82020 Few days of malaise headache ,no respiratory symptoms or chest pain Seen By cardiology at College no ECHO or Troponins as no symptoms of chest pain or SOB","H/o Peri Myocarditis hospitalized 11/2/19-11/5/2019 with ST elevation and elevated Troponins, normal biventricular function treated with IVIG F/u in 2020 doing well also seen in Cardiology Clinic 12/1/2020 Doing well ,no troponins but Holter placed x 24 hrs normal",,"none H/o Cow's milk hypersensitivity at 1 mos of age ,no problems with milk now","['Chest X-ray normal', 'Chest pain', 'Culture urine negative', 'Electrocardiogram PR shortened', 'Electrocardiogram normal', 'Headache', 'Immunoglobulin therapy', 'Malaise', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Pyrexia', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 test negative', 'Troponin increased']",UNK,MODERNA,IM 917836,FL,63.0,F,"Two days after vaccinated, injection site became red, swollen, and slightly itchy. Looked like a large welt. It is getting better today, 1/3/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,,None,Hayfever Reactive airways Mitral valve prolapse Bicuspid aortic valve,,Codeine produces agitation,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,PFIZER\BIONTECH,IM 917837,FL,78.0,F,12/31/20-pm upset stomach; 1/1 /21 woke up with diarrhea and mild headache thru the day. Around 7 pm felt like a dizzy spell loosing ability to move with like fog in my head and uncontrolled strong shaking and vomiting. 1/2/21 woke up with no symptoms and feeling fine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"atorvastatin, mirtazapine, sertraline, losartan",,arthritis,,no,"['Abdominal discomfort', 'Diarrhoea', 'Dizziness', 'Feeling abnormal', 'Headache', 'Mobility decreased', 'Tremor', 'Vomiting']",1,MODERNA,IM 917838,VA,41.0,F,"Headache, back pain 8 days after vaccine Shortness of breath, burning in chest, extreme fatigue, back pain, intermittent headache on days 9-13 after vaccine Temperature 100.0 on day 11 after vaccine COVID tests on days 9, 10, and 13 all negative",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/29/2020,8.0,PVT,"Vimpat 100mg, baclofen 10mg, naltrexone 4.5mg, modafinil 200mg, loratidine 10mg, buspirone 10mg, pindolol 5mg",None,"Trigeminal neuralgia, allergies, migraines, anxiety, polycystic ovary syndrome, sinus tachycardia",,"Sulfa, flexeril","['Back pain', 'Body temperature increased', 'Chest X-ray normal', 'Chest pain', 'Dyspnoea', 'Fatigue', 'Full blood count normal', 'Headache', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 917839,CO,56.0,F,"Moderna COVID- 19 Vaccine EUA: After vaccination patient reported dizziness and lightheadedness. Vital signs stable except pulse 106 beats per minute and blood pressure 145/94 mmHg. No loss of consciousness, rash, respiratory symptoms, or gastrointestinal symptoms reported. Repeat vital signs five minutes later all within normal ranges. Patient observed for a total of 45 minutes after vaccine administration. Symptoms resolved, no new symptoms developed, and patient left vaccine adminsitration clinic stable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,None reported,None reported,Earache,,Latex,['Dizziness'],1,MODERNA,IM 917840,CA,31.0,F,Patient c/o feeling tired and running out of breath on 12/31/20. Condition exacerbated on 1/2/20 and she thinks it may be due to anxiety. Patient will go to urgent care today for an evaluation (1/3/21),Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PHM,,,HX OF ANXIETY,,,"['Dyspnoea', 'Fatigue']",1,MODERNA,IM 917841,TX,32.0,F,"A week after vaccine (after initial soreness was gone) my arm began to hurt a lot. Vaccine site became stiff and developed rash/large bump. The day after this occurred the bumps went down but the area became inflamed, red, and warm to touch. The entire upper arm is still in a lot of pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,PHM,Adderall 20mg Clonazepam 1mg Nuvaring,None,None,,NKDA,"['Pain in extremity', 'Vaccination site erythema', 'Vaccination site inflammation', 'Vaccination site mass', 'Vaccination site rash', 'Vaccination site reaction', 'Vaccination site warmth']",1,MODERNA,SYR 917842,NJ,46.0,M,Onset of headache and nausea feeling a migraine coming on,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,PVT,,None,,,"Vicodine, Aleve -vomiting","['Headache', 'Nausea']",1,PFIZER\BIONTECH,IM 917843,OH,59.0,F,"I may have noticed small bumps on neck within 30 minutes of the first injection. Day 2 I experienced all day dull headache and muscle pain in the right arm. Approaching Day 6 roving hives(over the entire body), fever, tingling in the fingers, nausea, weakness, a feeling of about to pass out, and slight itching occurred.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,PUB,"Zinc, vitamin D, Biotin, and Triamterene-HCTZ 37.5-25MG TB",None,Hypertension,,"Codeine, Cats, some dogs, and environmental.","['Asthenia', 'Dizziness', 'Headache', 'Myalgia', 'Nausea', 'Pain in extremity', 'Paraesthesia', 'Pruritus', 'Pyrexia', 'Swelling', 'Urticaria']",1,MODERNA,SYR 917845,CA,25.0,F,"Severe fatigue, body aches, head aches since the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,UNK,None,None,None,,None,"['Fatigue', 'Headache', 'Pain']",1,PFIZER\BIONTECH,SYR 917846,KY,33.0,F,"Fatigue, metallic taste in mouth, increased thirst and urination, tinnitus, chills, achy, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"Low ogestrel, spironolactone, metformin, xyzal, protonix, bupropion, prenatal vitamin",None,"Chronic seasonal allergies, autoimmune dysfunction, anxiety/depression",,"Augmentin, doxycycline, benzonatate, indomethacin","['Chills', 'Dysgeusia', 'Fatigue', 'Headache', 'Pain', 'Pollakiuria', 'Thirst', 'Tinnitus']",1,MODERNA,IM 917847,TN,45.0,F,"Initially: pain at injection site x 3 days On Day 7... worsening pain at injection site, arm red, swollen and painful to touch. Fever 100.1, joint pain and terrible headache. On Day 8 - rapid Covid negative Treating for suspected cellulitis on left arm at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,UNK,None,None,None,,None,"['Arthralgia', 'Erythema', 'Headache', 'Injection site cellulitis', 'Injection site pain', 'Injection site swelling', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 917848,AR,40.0,F,Golf Ball size hard knot at injection sight with redness and warm to touch,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,SEN,"Bystolic, Prevacid, Potassium, Lasix, Lexapro, Topamax",None,High Blood Pressure controlled with medication,,None,"['Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site warmth']",1,MODERNA, 917849,TX,55.0,F,"Headache - took Tylenol, ongoing Burning all over body - took Benadryl, resolved Dizziness - rest Cough",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,OTH,"MYFORTIC, Prograf, DELTASONE, levothyroxine, amLODIPine, carvediloL, estradioL",,"Liver transplant, polycystic kidneys",,"Penicillin, morphine, meperidine, sulfamethoxazole, hydrocodone","['Burning sensation', 'Cough', 'Dizziness', 'Headache']",UNK,MODERNA, 917850,,,U,"Soreness/ Tenderness around injection site. Muscle soreness 3"" side to side of site. Muscle soreness 5"" above & below site. First occurrence Day of. Continued thru 24hrs AFTER injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Injection site pain'],1,MODERNA,IM 917851,CO,29.0,F,"Moderna COVID- 19 Vaccine: Patient reported nausea, dizziness, lightheadedness soon after receiving vaccination. Vital signs stable except for blood pressure 162/87 mmHg. Patient observed and offered water and juice. No rash, respiratory symptoms, loss of consciousness, or gastrointestinal symptoms reported. Repeat vital signs all within normal ranges. Symptoms resolved, no new symptoms developed, and patient left vaccine clinic in stable condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,norelgestromin and ethinyl estradiol,None reported,None reported,,Sunscreen,"['Dizziness', 'Nausea']",1,MODERNA,IM 917852,NY,32.0,M,"Swollen axillary lymph node, tender",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/30/2020,6.0,PVT,None,None,None,,None,"['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 917853,WV,36.0,F,"Moderns COVID-19 Vaccine Sat at about 8pm started to have arm pain in the arm vaccinated. Throughout the night muscle, aches, headaches, fever, chills and fatigue started. Treated with Tylenol. Sunday moring fever, headache and chills were gone. Noon on Sunday, chillw and fever came back. 4pm checked temp and it was 103 degrees. Took Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,,,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA, 917854,PA,57.0,F,"Patient received vaccine and was fine through her 15 minute observation period. She left the clinic and came back about 40 minutes later complaining of tingling in her tongue and weakness in her legs and felt like she needed to sit down. Her blood pressure was taken and it was elevated and a decision to take her to the ED was made. In the ED, she denied shortness of breath and did not have any other signs of anaphylaxis. She was given diphenhydramine 50 mg (at 11:36AM), famotidine 20 mg (@11:36AM) and prednisone 50 mg (at 11:43AM). At 12:23PM, documentation from the ED notes that tongue symptoms resolved, but patient still felt weak.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,Unknown,,Past Medical History : Breast Cancer Right Bundle Branch Block Hypthyroidism,,NKA,"['Asthenia', 'Blood pressure increased', 'Muscular weakness', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 917855,CA,47.0,F,"ON 1/1/21 THE DAY AFTER I RECEIVED THE VACCINE I WAS TAKING A NAP AND MY WATCH KEPT SENDING ME ALERTS. HOWEVER I DID NOT CHECK MY WATCH UNTIL 5:30 WHEN I WOKE UP AND I FELT LIKE I WAS HAVING HEART PALPITATIONS. I WENT TO THE EMERGENCY ROOM WHERE I WAS TREATED. I WAS TOLD THAT I WAS FEBRILE WITH A TEMPERATURE OF 102. I WAS GIVEN IV FLUIDS, CHEST X-RAY, EKG AND LAB WORK. I WAS RELEASED ON 1/2/21 AT APPROXIMATELY 0030 (MIDNIGHT).",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/31/2020,01/01/2021,1.0,WRK,NONE. HOWEVER I DID TAKE BENADRYL PROPHYLACTICALLY JUST IN CASE BECAUSE I HEARD OF PEOPLE HAVING ADVERSE REACTIONS TO BOTH MODERNA AND PFIZER COVID VACCINE.,NONE,NONE,,SULFA,"['Chest X-ray', 'Differential white blood cell count', 'Electrocardiogram', 'Full blood count', 'Human chorionic gonadotropin', 'Metabolic function test', 'Palpitations', 'Pyrexia']",1,MODERNA,IM 917856,MN,39.0,F,"23rd: hot flash/sweating within 15 minutes of receiving vaccine, Sore am, itchy throat, horse voice; 24th: sore arm, headache, fatigue, congestion; 25th: headache, nausea, fatigue, congestion. 26th through today - daily Headache w/nausea (OTC's not helping headaches).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,None,none,none,,"Tree nuts, ground nuts, mangos, sunflower seeds","['Dysphonia', 'Fatigue', 'Headache', 'Hot flush', 'Hyperhidrosis', 'Nausea', 'Pain in extremity', 'Respiratory tract congestion', 'Throat irritation']",1,PFIZER\BIONTECH,IM 917858,OH,45.0,F,"Day 1: within 30 min - severe sharp temporal headache (worst of my life); developed within a couple hours in this sequence: cold hands/feet, chills (no fever), much worsened vision, slight confusion/dizziness, weakness (had to lay down), both knee joint pain, swollen neck glands, moderate nausea and intestinal cramps, complete loss of smell/taste; all night - severe acidic stomach pain (barely relieved with anti-acids). Day 2: residual headache (50%), tiredness, weakness, sweating if doing things, residual knee joint pain, sense of smell/taste returned and heightened. Day 3: residual headache (25%), still not 100%, residual knee joint pain. Day 4 (today): residual knee joint pain (comes and goes). I realize that these are not symptoms of an allergic reaction, but severe side effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,"just vitamins, supplements, herbs no any OTC or prescription drugs",none,none,,"PCN (anaphylactic), metals, mint","['Abdominal pain upper', 'Ageusia', 'Anosmia', 'Arthralgia', 'Asthenia', 'Chills', 'Confusional state', 'Dizziness', 'Fatigue', 'Gastrointestinal pain', 'Gastrooesophageal reflux disease', 'Headache', 'Hyperhidrosis', 'Lymphadenopathy', 'Nausea', 'Peripheral coldness', 'Visual impairment']",1,MODERNA,IM 917859,NY,65.0,M,"High Fever. 101+, thermometer could read it. Severe joint pain, especially in shoulders, knees.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,OTH,Numerous,Covid,Arthritis,,Flaygel,"['Arthralgia', 'Pyrexia']",2,MODERNA,IM 917860,,44.0,F,slight/mild soreness at site of injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,UNK,,,,,,['Injection site pain'],UNK,MODERNA,IM 917861,NY,62.0,M,"After eating lunch on 12/29, he felt nauseated and dizzy, vomited within 10 mins and felt dizzy, there was some orthostatic BP changes clinically, he was at work in the hospital on that day, he was taken to ED, kept under observation for 24 hours, cardiac workup was done, non specific EKG abnormality was noted and he got a stress test on the 30th, which showed a normal stress perfusion study and normal cardiac function. He was discharged from observation status. No further dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/29/2020,7.0,PVT,Mogamulizumab Bactrim Acyclovir Synthroid,,Cutaneous T cell lymphoma Ulcerative Colitis - has K-pouch Hypothyroidism,,NKDA,"['Blood pressure orthostatic abnormal', 'Cardiac stress test normal', 'Dizziness', 'Nausea', 'Vomiting']",1,MODERNA,IM 917862,,29.0,F,Slight/mild soreness at site of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,UNK,,,,,,['Injection site pain'],UNK,MODERNA,IM 917863,VA,26.0,M,"Myalgias starting within 1 hour after vaccination, worsened throughout day that radiated to ipsilateral trapezius and rhomboid areas. Starting around 16 hours after vaccination, severe subjective fevers and chills with severe headache that worsened with lying down. The headache was the most concerning symptom with tinnitus when laying flat in supine. It awoke me from sleep and prevented me from laying flat so I had to sleep upright on the couch. I took tylenol 500mg around 0200 and was able to sleep for a few hours. By 24 hours post vaccine, the headache and fevers/chills significantly improved so I could attend work the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,None,None,None,,None,"['Chills', 'Headache', 'Myalgia', 'Pain', 'Pyrexia', 'Tinnitus']",1,PFIZER\BIONTECH,IM 917864,OH,23.0,M,Fever for around 24 hours without use of fever-reducing medication; Chills; Headache; slight nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,UNK,None,None,None,,None,"['Chills', 'Headache', 'Nausea', 'Pyrexia']",1,MODERNA,IM 917865,NJ,18.0,F,intense chills and arm pain starting ~5 hours after shot (child faded within 24 hours) arm soreness lasted ~3 days general intense fatigue and light-headedness/ headache; decreased and went away after 48 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,UNK,,"viral cold 3 weeks before (throat pain, chills, fever, fatigue) - NOT COVID (tested negative), or Flu (symptoms only lasted 48 hours and lower fevers)",,,,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Pain in extremity']",1,MODERNA,IM 917867,TN,32.0,F,"Pfizer-BioNTech COVID19 Vaccine EUA The muscles in my arm where the vaccine was objected started hurting about 5 hours after the vaccine. Two hours later the pain had gotten so intense I could not move my arm more than in inch from my body and had to get help performing simple tasks. The next morning, the pain is less intense and I can move my arm, but there is no pain in my elbow and wrist joints on the same arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,"Gilenya, synthroid, vitamin D, Zyrtec, birth control",Strep throat,Multiple sclerosis,,"Apples, cherries, strawberries, pears, peaches, nectarines, apricots, almonds, carrots","['Injection site pain', 'Mobility decreased']",UNK,PFIZER\BIONTECH,IM 917868,TX,41.0,F,A few minutes after receiving her vaccine she reported dizziness and an itchy throat. She was observed for a few minutes and she stated that the dizziness was worse and that she felt flushed so she was given 0.3mg of IM epinephrine after which she began to immediately improve. She was also given 50mg PO diphenhydramine. She was observed for 60 minutes after the epinephrine dosing without any recurrence of her symptoms and she was discharged home with strict ER return precautions.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,MIL,"Vitamin D, Iron, Multivitamin",None,None,,NKDA,"['Dizziness', 'Throat irritation']",1,PFIZER\BIONTECH,IM 917869,IN,46.0,F,"Started to lose voice and clearing throat- took benedryl as suggested , stayed an extra hour for observation, left on my own. Noticed face was swollen and red after showering- took photo. Cough and clearing throat like when I eat something I?m allergic to. Took another benedryl four hours later as well as Tylenol for headache. Ate dinner went back to sleep notice arm hurts a bit. Next morning 9 am face no longer swollen but arm hurting to the slightest touch. 4:30 pm still resting arm very painful . Headache and facial swelling under control. At no time did I have trouble breathing, slight itching",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,OTH,Zyrtec singular symbicort nasocort azelastine spirolactone Hydroxychloriquinine edotolac pantaprozole button- acetaminophen-caff promethazine clonazapam vitamin C Xyponex abuterol,Sinus infection just finished cefadroxil and mucinex,Allergies asthma positive Ana arthritis,,"Iodine, sulfur, levaquin, compazine, propafill, loratab, Xanax, egg, fish shellfish pork orange mango chocolate avacado","['Cough', 'Dysphonia', 'Erythema', 'Headache', 'Pain in extremity', 'Pruritus', 'Swelling face', 'Tenderness', 'Throat clearing']",1,PFIZER\BIONTECH,IM 917870,MA,42.0,F,"Woke up with severe chills, shaking, fever of 100.8, generalized body aches, generalized sensitive skin, and mild headache. All symptoms resolved after 1 day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,PVT,,,,,,"['Chills', 'Headache', 'Pain', 'Pyrexia', 'Sensitive skin', 'Tremor']",1,PFIZER\BIONTECH,IM 917871,FL,27.0,M,Body Aches Chills Headache Low Grade Fever Arm Soreness Swollen Lymph Nodes GI Upset,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PUB,Effexor XR 75 MG QD Adderall 20 MG QD,,ADHD Depression,,Ceclor Wellbutrin Shellfish,"['Abdominal discomfort', 'Chills', 'Headache', 'Lymphadenopathy', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 917872,AL,62.0,F,"I started feeling just slightly sick by bedtime on the date of the vaccine. For the next 24 to 36 hours, I experienced: low grade fever (101.1), muscle aches and pains, bad headache, diarrhea ... and felt extremely tired ... felt much the same as when I had been diagnosed with Covid 19 back in October of 2020. By the day, I was feeling better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,Losartan 50 mg Low Dose Aspirin 81 mg Glucosamine Chondroitin (Triple Strength) Calcium 600 mg & Vitamin D3 800 IU Iron 65 mg Vitamin D3 (either 1000 or 2000 IU ) Multivitmin (like One-A-Day for Women) Vita,None known,Crohn's Disease (since age 23) High blood pressure (take prescription Losartan) Currently have some vaginal discomfort; will be scheduling a doctor appointment this week Currently have some skin disorders for which I will be seeing a dermatologist ASAP (have recently obtained medical insurance),"The flu vaccine, although the side effects were not nearly so severe and/or significant",None known,"['Diarrhoea', 'Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 917873,MA,29.0,F,"Approximately 5 hours after administration, I developed severe pleuritic chest pain and tachycardia that self resolved after about an hour. This was followed by about 2 days of fatigue and myalgias that interfered with my daily activities that also self resolved. Had a large tender reaction on my left bicep for about 5 days after the injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,None,,"Celiac disease, Asthma, Graves disease, Anaphylactic food allergies, seasonal allergies",,Nut allergy,"['Chest pain', 'Fatigue', 'Injection site pain', 'Loss of personal independence in daily activities', 'Myalgia', 'Pleuritic pain', 'Tachycardia']",1,PFIZER\BIONTECH,IM 917874,TX,29.0,F,"8 hours post injection: headache, joint pain and body aches progressively worsened through 48 hours after injection. Arm was sore but nothing compared to joints (especially hips). Temperature was only slight at 98.7. Headache and body aches, joint pain were severe enough that I was forced to rest and unable to continue daily activities. Ache symptoms quickly dissipated after 48 hours, but a 2 inch diameter welt appeared, slightly raised and itching mildly like a mosquito bite. Welt is still present now, 5 days post-injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,SCH,Nutrifol and melatonin,None,None,,None,"['Arthralgia', 'Headache', 'Loss of personal independence in daily activities', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Urticaria']",1,MODERNA,IM 917875,MD,31.0,F,Febrile to 100.1 F with chills requiring Tylenol 500mg to sleep through the night after getting the vaccine .,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,"Zyrtec, glucosamine and chondroitin",,,,Rash to tetracycline,"['Chills', 'Pyrexia']",1,MODERNA,IM 917876,MI,36.0,F,"Started with throat and chest tightness, followed by cough and unable to catch breath, wheeled to ER given nebulizing treatment, 0.3mg of Epi, 50 mg IV Benadryl and 125mg IV solumedrol, chest tightness, tachycardia, and cough seemed to abate for aprox 15 minutes before return of symptoms, but worse. HR 140-150, BP 180/104, tachypneic high 30's, feeling like unable to breath, throat did not close, duoneb inhalant treatment given with 02, sx seemed to calm after 15 minutes. Pt d/c home after 3 hours in ER with bp 138/98, HR 134, 20 resps, SP02 @ 97%. SP02 never dropped below 95% throughout severe allergic reaction",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Metformin XR, Metoprolol ER, Celebrex, Chlorzoxazone, Aciphex, Singuliar, Xyzal, Vitamin D3, Benadryl","Sinus Infection, Asthma attack","PCOS, Ehler's -Danlos type III, HTN, tachycardia, Pre-eclampsia",,"Medication: Fenofibrate: severe myalgia Food sensitivities: allspice, Lima bean, String bean, Beef, pepper (all kinds/ varieties/ forms), Casein, Cod, Coffee, Corn, Cranberry, Flounder, Garlic, White grapes, green beans, Sesame seed Environmental: Queen Palm trees, Rye, Mixed grass, cut grass, Goldenrod, Trichophyton Mentagrophytes, Early Tress, cotton wood","['Chest discomfort', 'Cough', 'Dyspnoea', 'Hypersensitivity', 'Tachycardia', 'Throat tightness']",1,MODERNA,IM 917877,CO,66.0,F,"Headache, low fever 99.9-100, chills, fatigue started 1/3/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,WRK,"Elderberry supplement, lysine with vitamin C supplement, B12 vitamin, ibuprofen, acetaminophen","Sinus , migraine","Arthritis, allergies",,"Allergic to sulfa drugs, tetracycline, strawberries, pineapple, spearmint","['Chills', 'Fatigue', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 917878,FL,62.0,F,"Within minutes of receiving the injection I began to feel dizzy, a nursing provider took my bp approx 5-6 min after receiving the vaccination with a wrist cuff and it was 191/125 , she obtained a manual cuff and took it about 3- 5 min after the initial bp and it was 180/100. I felt more dizzy and laid down. I also had a rapid HR but did not take my pulse. The dizziness fluctuated and gradually cleared over 20-30 min. A third bp was 146/84 and a last bp approx 30min after the injection was 124/76 and I felt well enough to get up and walk.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,"celebrex 100mg BID, methotrexate injection weekly. propranolol 10mg BID, zovirax 400mg BID, wellbutrin 300mg XL daily, estrogen patch, progesterone 200mg daily, multivitamin daily, vit D3 2,000 units, folate 800mcg 2 days of week, fish o",no acute illness,"rheumatoid arthritis, visual migraines",local reaction to MMR w/ redness/ swelling ; given May 2020,"theophylline , plaquenil, many food allergies but no anaphylaxis, many environmental allergies but no anaphylaxis","['Dizziness', 'Heart rate increased']",1,PFIZER\BIONTECH,IM 917879,WV,64.0,F,Right side of lip started swelling about 7:30 pm on 12/31/2020. Took Benadryl and picked up Epi pen at pharmacy. Swelling increased overnight up into right cheek and jaw. Right side eye and cheek and mouth drooping with a crooked smile. On 01/02/2020 started itching from up under right ear down towards neck with redness and hives. Got RX from pharmacy for Prednisone and am currently taking that,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,Lisinopril. Ellura.,2 weeks prior. Had some swelling in jaw area,High Blood Pressure. Graves? disease which has been inactive for several years,,Penicillin,"['Facial paralysis', 'Lip swelling', 'Pruritus', 'Swelling face', 'Urticaria']",UNK,PFIZER\BIONTECH,IM 917880,MT,45.0,M,Moderna COVID-19 Vaccine EUA Headache for about 16 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,None,None,None,,Penicillin,['Headache'],1,MODERNA,IM 917881,WV,59.0,F,"Had the vaccine at 11am; started diarrhea within the hour. Restless during the night and about 3am woke with diarrhea, nausea and having dry heaves, general feeling of malaise. Symptoms continued to get worse and finally went to the emergency room about 9am the next morning. I was given fluids for dehydration and Zofran for the nausea. Lab work was performed as well as x-rays and a CT Scan.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PHM,"Xarleto, Lexapro, Carafate, Calcium, Vitamin D, Arthrotec, Klonipin","COVID, Dec 19","History of blood clot, depression, GERD",,"PCN, Sulfa, Keflex","['Computerised tomogram', 'Diarrhoea', 'Laboratory test', 'Malaise', 'Nausea', 'Restlessness', 'Retching', 'X-ray']",1,MODERNA,IM 917882,NJ,49.0,F,"Patient is hospital employee who completed screening form for COVID-19 vaccine by answering ""no"" to all contraindication questions. Approx 10 minutes after receiving COVID-19 vaccine dose # 1, patient was still in vaccine clinic area and complained of dizziness, palpitations and flushing. I observed patient fanning herself with papers. She was escorted out of the immediate clinic room, and assessed by paramedics present as having an anaphylactic reaction. Epinephrine 0.3 mg IM and diphenhydramine 50 mg IV given in clinic, Rapid Response was called overhead and patient immediately transported down the hall to the Emergency Dept. In ED, pt was noted as having swollen tongue, large areas of erythema on face, arms and chest, shortness of breath, nausea, dizziness (per ED physician notes). Pt reported being hospitalized in ICU with COVID disease more than 3 months ago, including intubation (not treated at this hospital), and has been back at work since August 2020. ED physical exam noted bilateral wheezing and patient in acute distress. In ED, pt administered racemic epinephrine 2.25% 0.5 mL via neb, epinephrine 0.3 mg IM, diphenhydramine 50 mg IV, Solu-Medrol 125 mg IV, famotidine 20 mg IV and epinephrine 5 mg/250 mL IV drip (started at 0.118 mcg/kg/min). Acute symptoms reported to resolve in ED. COVID test was negative. ED physician discovered that pt had history of multiple medications, including previous anaphylactic reaction to radiocontrast dye requiring intubation (which was not disclosed on the vaccine screening form). Pt admitted to Telemetry floor for observation. Overnight course was unremarkable, and patient was discharged the following day with prescription for Prednisone taper and prescription for Epi-pen. Advised not to return for second dose of COVID vaccine. EMR updated to reflect possible anaphylactic reaction to Moderna COVID-19 vaccine.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,"Biotin 1 mg PO daily, Levothyroxine 112 mcg PO daily, MVI tablet PO daily, Paroxetine 20 mg PO QHS",none reported,Past Medical History (as noted in H&P) ? Acquired hypothyroidism � ? Anxiety � ? Chronic deep vein thrombosis (DVT) of distal vein of lower extremity � ? Chronic midline low back pain � ? Complex regional pain syndrome I � ? Essential hypertension � ? Fibromyalgia � ? Gastroesophageal reflux disease without esophagitis � ? History of pseudoseizure � ? Laryngospasm � ? MDD (major depressive disorder) � ? RSD (reflex sympathetic dystrophy),,"cefuroxime (shortness of breath), gadolinium (anaphylaxis, March 2018), iodine (anaphylaxis), quinolones (shortness of breath, ""paralyze""), gabapentin (hallucinations), vancomycin (itching)","['Anaphylactic reaction', 'Dizziness', 'Dyspnoea', 'Erythema', 'Flushing', 'Nausea', 'Palpitations', 'Respiratory distress', 'SARS-CoV-2 test negative', 'Swollen tongue', 'Wheezing']",1,MODERNA,IM 917883,KS,50.0,F,"After vaccination in exam room, client sent to observation room for 30 minutes. About 5 minutes in the observation room, client started to feel light headed. Client sent back to exam room to lie down. At 2pm, client's blood pressure 107/70 with 98 pulse. At 2:15pm, client's blood pressure 128/79, 99 pulse, and O2 sat at 99%. Cold compress place on client's forehead with knees elevated. Water and snack provided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PUB,,,,,Celebrex,['Dizziness'],1,MODERNA, 917884,NC,35.0,F,"Hives began one week after vaccine. Went to urgent care on two different occasions, initially told to continue Otc antihistamines, given prescription at second visit.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/28/2020,7.0,UNK,Birth control pill,Na,Na,,Penicillin,['Urticaria'],1,PFIZER\BIONTECH,SYR 917885,MO,56.0,M,"Fatigue, lightheadedness, Fever (99.9-100.1), nausea and weakness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,PVT,Morning 1. Zoloft 200mg 2. GLUCOSAMINE AND CHONDROITIN 3. Magnesium Oxide - 200mg Nighttime 1. Singulair - 10mg 2. Omeprazole - 40mg 3. Lorazepam - 2mg 4. Magnesium Oxide - 400mg 5. Trazodone - 100mg,None,"Panic disorder, Gerd, depression",,Allergy to gabapentin- nausea/vomiting,"['Asthenia', 'Dizziness', 'Fatigue', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 917886,PA,58.0,F,"Vomiting, Fever 101.4, myalgias, fatigue-unable to work for 24 hours sit of injection erythema for 4 days, soreness These were similar symptoms to when patient had COVID in November",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,Enalapril,"COVID infection verified by PCR November 12,2019",Mild CRF,,PCN,"['Fatigue', 'Impaired work ability', 'Injection site erythema', 'Injection site pain', 'Myalgia', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 917887,MD,23.0,F,"About 5:45 pm on Saturday, January 2, 2021 my inner left eye began to feel itchy and irritated like there was something in it. I touched my eye and rubbed it for approximately 30 minutes, but it still felt like I had something poking my inner eyelid. I looked in the mirror and saw my inner, upper, left eyelid was swollen and slowly getting worse. I tried applying a warm compress for 10 minutes, but it did not seem to help. I was getting ready for a shower and saw hives on my hips and inner thighs. I felt itchy in other places of my body as well. I saw hives on both of my upper arms, my back, and my neck. I took one 25 mg Benadryl and got in the shower. As I was showering, I felt my left upper lip begin to tingle and swell. I rushed to the ER immediately. I arrived around 7:25 pm. As I was waiting for the ER doctor, I noticed my lip and eye swelling were almost back to normal, but I still had hives and they were spreading. The ER doctor gave me Benedryl and Solumedrol in an IV around 9 pm. I left the ER around 10 pm. I had no more swelling on my eye and lip and my hives were slowly diminishing.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/02/2021,2.0,PUB,Junel 1/20,None,None,,None,"['Eye irritation', 'Eye pruritus', 'Lip swelling', 'Paraesthesia oral', 'Pruritus', 'Swelling of eyelid', 'Urticaria']",1,MODERNA,SYR 917888,NM,35.0,F,I am breastfeeding my 15 month old son and he got a rash on his abdomen and face that has progressed more over past several days. He has had no fever but acts like he doesn?t feel great as he was not eating like his normal self. I don?t know if the rash is related or not but it is during the time of the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,UNK,"Vitamin D, multivitamin",None,None,,No,['Maternal exposure during breast feeding'],1,PFIZER\BIONTECH,SYR 917890,,41.0,M,Chill-1 episode; fatigue; muscle ache; headache,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/03/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Myalgia']",1,MODERNA,IM 917891,CT,41.0,F,"Sweated through my clothes at almost 12 hours to the exact time of dose, nausea to the point of trying not to vomit, diarrhea, shivers, very sore arm (difficult to lift). Lasted approximately 4 hours. Drank water, took 1 Advil. Waited it out until symptoms reduced. Did not sleep most of the night.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,PVT,"Pristiq 50mg, xyzal 5mg, The Big One multivitamin, Turmeric, Vitamin D 1,000, Vitamin C 1,000, elderberry syrup, probiotic 25 billion, Flonase nasal spray, Azelastine HCI nasal spray",No,No,,None,"['Chills', 'Diarrhoea', 'Hyperhidrosis', 'Insomnia', 'Mobility decreased', 'Nausea', 'Pain in extremity']",1,MODERNA,IM 917892,NY,66.0,F,"Received vaccine on Thursday arm was sore on Friday, Saturday morning @5:OO AM woke with horrendous headache and slept most of the day, very tired. Woke in the middle of the night to go to the bathroom and had horrible vertigo actually bouncing off the walls. Took Meclizine and benadryl for relief. Wondering what my immune system will do on the second dose!",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,PVT,"Carvedolol, escatalapram, HTZT, St. John's Wort, adrenal tonic, turmeric, chelated multiple vitamin",none,"in remission of Lyme Disease, High BP, Anxiety",,"PCN, Ceftin, Ciprol","['Balance disorder', 'Fatigue', 'Headache', 'Hypersomnia', 'Pain in extremity', 'Vertigo']",1,MODERNA,IM 917893,TX,28.0,M,"approximately 10 minutes after vaccination, the individual began complaining of difficulty breathing. Presented to onsite EMS personnel with diaphoresis, pallor, rapid respiratory rate, and sounds from throat similar to stridor. The individual was in obvious distress. Patient was given oxygen via NRB mask, Epinephrine 1:1,000 0.3 mg IM. A second dose of Epinephrine 1:1,000 0.3 mg IM was given approximately 4 minutes after the first one. Transporting ambulance arrived and transported the patient to emergency room. The patient's had marked improvement within 5 minutes of the second Epinephrine dose. Patient was still tachypneic but was able to speak in complete sentences and was alert and oriented.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,OTH,Unknown,None reported,None reported,,None reported,"['Dyspnoea', 'Hyperhidrosis', 'Pallor', 'Respiratory rate increased', 'Stridor', 'Tachypnoea']",1,MODERNA,IM 917894,CO,42.0,F,"My husband noticed my that my arm near the injection site was red and raised last night, January 2nd - over one week after the vaccine. Then I was woken up around 1 in the morning January 3rd (today) with fairly intense itching at that site. Today it is raised, red, and mildly itchy. We took pictures to show the difference in arms. Of note, the pain from the vaccine was so severe I couldn?t even pick up a water glass or put a shirt over my head with that arm. It was only that bad on 12/27 and rapidly improved. I am just mentioning this in case people who have had itching over one week also had severe pain after the injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,UNK,"Lexapro, vitamin B, trazodone",None,"Depression, insomnia, exercise induced asthma",,"Penicillin, sulfa","['Injected limb mobility decreased', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Pain in extremity']",1,MODERNA,IM 917895,MI,36.0,F,Pt experienced tachycardia and was monitored. This returned to normal in a few minutes.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,"birth control, vitamins, Lexapro",none known,"migraine, obesity, anxiety",,NKDA,['Tachycardia'],1,PFIZER\BIONTECH,IM 917896,AZ,68.0,F,"Nausea, fever, muscle aches, headache, dizziness, body pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,none,none,none,,none,"['Dizziness', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 917897,CA,65.0,F,"Injection was at 12:00 Pm on 12/29/2020. At 12:20 PM i started to feel faint, slightly nauseous . I layed down on my office floor, , my heart rate went up to 140 BPM and BP was around 140/76. My MA checked it . One of my physician colleague's that was nearby checked on me as well as the nurse that gave me the injections. it took about 30-40 minutes for the symptoms to subside. I was sent to our Urgent care dept in the same clinic by wheelchair at around 12:30-12:40 pm. I was evaluated and my symptoms subsided in 30-40 minutes. I was out of Urgent care at 1:25 pm, able to walk upstairs back to my office and felt okay and was seeing patients again at 1:30 PM. This reaction was similar to getting a shot of Novocaine w/ epinephrine for a dental procedure I received a few years ago, so if I were to sum it up it was like getting a shot of epinephrine. it was not a vasovagal reaction as my BP was high. I have felt fine since. I plan to get the second vaccine. Any suggestions to avoid these symptoms w/ the second one would be appreciated.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,"1. Celebrex, 100 mg per day 2. Pepcid AC 10 mg per day 3. Combipatch, 0.05mg/0.14 mg, 1/2 patch every 3 weeks for hot flashes",none,No,,Benadryl- causes tachycardia,"['Blood pressure increased', 'Dizziness', 'Heart rate increased', 'Nausea']",1,MODERNA,IM 917898,NH,50.0,F,"7 days after receiving the vaccine, my arm became very itchy at the site of the injection. That evening, I noticed a golf ball size red swollen area around the injection site. The next morning, the reddened area had increased to the size of a baseball. It remained itchy, red, swollen, and warm. By that evening, the area had increased to the size of a canteloupe. I presented to the local Urgent Care. I was diagnosed with ""cellulitis"" and prescribed an antibiotic. I did not take the antibiotic, as by the time I picked it up from the pharmacy the next morning, the redness and swelling had already started to decrease. At this time, (10 days after vaccine), the redness and swelling are gone, and my arm just remains a little itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,WRK,None,none,none,,amoxicillin bactrim,"['Cellulitis', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 917899,NE,34.0,F,"Patient was COVID + on 11/7/20, but had fully recovered by the vaccination date 12/24/20. The vaccination was unremarkable and the patient tolerated. Approximately 72 hours post-vaccination, the patient developed widespread hives, that were most severe on her face and cheeks. Patient did not have any respiratory effects. Hives resolved within 24 hours with the use of oral diphenhydramine. The patient is concerned with obtaining the second dose, whether it would be appropriate to receive the vaccine as long as appropriate medical interventions are available.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/27/2020,3.0,PVT,No medications,No recent illness or vaccination within prior month.,None,,No known drug allergies,['Urticaria'],1,MODERNA,IM 917900,,20.0,F,"Slight/mild dizziness and slight/mild numbness sensation of left arm, five minutes after vaccine administration (left deltoid). Patient stated she had not sleep last night. Patient reported feeling better after sitting in the clinic. Vital signs within normal limits. Advised to follow up with PCP. ER precautions given.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,UNK,,,,,,"['Dizziness', 'Hypoaesthesia']",UNK,MODERNA,IM 917901,TX,49.0,F,High blood pressure. I normally have low blood pressure. My readings have been up to 190/127. I've never had a reading over 140 before. Last reading was 149/100.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,01/02/2021,32.0,PVT,None,None,None,,None,['Blood pressure increased'],1,MODERNA,SYR 917902,CO,45.0,F,"Moderna COVID-19 Vaccine EUA Fever, joint pain, headache, nausea. Treated at home with OTC meds Severe rash on torso, arms, neck, thighs. TakingSteroid dose pack, Benedryl, Ibuprofen. Not yet resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PUB,,,,,,"['Arthralgia', 'Headache', 'Nausea', 'Pyrexia', 'Rash']",UNK,MODERNA,IM 917903,TN,37.0,F,Moderna COVID-19 Vaccine EUA After receiving shot 1 at 8:56 AM I started running a fever of 101 by 6:00 PM on 1/2/21. By 7:30 PM it was 102.8. I alternated Tylenol and Ibuprofen which took over an hour to have any impact on the fever. I have used ice packs to also control my body temperature throughout the night. I woke up with fever and have run fever all day 1/3/21. It is 4:49 PM and it is currently 101.4 which is 20 minutes after my Tylenol has worn off. I am also experiencing intestinal issues and started having diarrhea at 3:30 PM on 1/3/21. I am very concerned about taking dose 2!,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,PUB,"Multi-vitamin, D3",None,None,,None,"['Diarrhoea', 'Pyrexia']",1,MODERNA,SYR 917904,IL,27.0,F,"Malaise, fatigue, chills, headache, dizziness, and nausea from 12 hours post vaccine until 48 hours post vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,UNK,Birth control (lo estrin),Sore throat 3 days prior,None,,NKA,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Malaise', 'Nausea']",1,MODERNA,IM 917905,KS,41.0,M,Fever with chills for 2 days Weakness/malaise/muscle pain for 2 days. Hives with itching for 1 day,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,,,,,,"['Asthenia', 'Chills', 'Malaise', 'Myalgia', 'Pruritus', 'Pyrexia', 'Urticaria']",1,MODERNA,SYR 917906,TX,56.0,F,Moderna COVID-19 Vaccine EUA Fast heartbeat (117) Chills Headache Nausea Fatigue (Day after vaccination),Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2020,01/03/2020,1.0,SCH,Losartan Simvastatin Metformin D3 OMEGA-3 B12,,High blood pressure Diabetes High cholesterol,,,"['Chills', 'Fatigue', 'Headache', 'Heart rate increased', 'Nausea']",1,MODERNA,SYR 917907,VA,65.0,F,"Metallic taste a couple of minutes after vaccination, it disappeared after 30 minutes or so Swallowing lips 4 hours after injection. Numbing sensation on lower lip. This effect lasted 3 to 4 hours Headache, and backache and increase in temperature the next morning 01-03-21 Symptoms improving during the afternoon",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,OTH,none,none,chronic pancreatitis,,"local anesthetic, hair dye,","['Back pain', 'Body temperature increased', 'Dysgeusia', 'Headache', 'Hypoaesthesia oral', 'Lip swelling']",1,MODERNA,IM 917908,FL,39.0,F,"Flushing, started about 5h after vaccination, lasts a few minutes, has occurred daily . Fatigue/aches, started ~48h after vaccination, usually occurs in the afternoon, enough for me to need a nap, has occurred daily.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,Nuvaring Protonix 40mg daily Prenatal gummy vitamin Bcomplex vitamin Turmeric-ginger gummy vitamin,None,Frequent PACs GERD Irritable bowel PCOS,,NKA,"['Fatigue', 'Flushing', 'Pain']",1,MODERNA,SC 917909,FL,62.0,F,Rash at vaccine injection site 1 day after Dupixent leg injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/03/2021,8.0,WRK,Dupixent 300 mg administered 1 week after vaccine in left arm. Dupixent administered in left leg. One day after Dupixent and 8 days after vaccine I developed a rash at the vaccine injection site.,,Eczema,,"Actonel , Eucrisa",['Injection site rash'],UNK,MODERNA,IM 917910,CA,42.0,M,"Approximately 5 hours after the injection my left arm (injection site arm) became sore. The soreness ended on January 3rd. No treatment was needed. On January 1st I noticed tingling in both of my legs. Since then it has gotten worse. I have tingling in both legs, muscle twitching throughout both legs intermittently, muscle weakness specifically after muscle use, an abnormal skin sensitivity when wearing pants, and a consistent ache throughout my legs. The symptoms affect me 24 hours a day and create an anxiety that I have not felt before. It has also adversely affected my sleep.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,Lipitor 20mg,None,Asthma as a child.,,None,"['Anxiety', 'Hyperaesthesia', 'Muscle twitching', 'Muscular weakness', 'Pain in extremity', 'Paraesthesia', 'Sleep disorder']",1,MODERNA,IM 917911,MA,32.0,M,Left T11-12 zoster reactivation,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/31/2020,3.0,PVT,"Effexor, loratidine, finasteride",None,None,,None,['Herpes zoster reactivation'],UNK,MODERNA,IM 917912,MO,37.0,F,"Body aches, chills, exhaustion, fever, injection site itching, swelling and redness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Zoloft, Wellbutrin, adderall",,,,,"['Chills', 'Fatigue', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 917913,,31.0,F,severe headache lasting 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,PVT,"pristiq 100mg daily, trazodone 100mg daily, multivitamin, claritin.",,,,"keflex, bee stings",['Headache'],1,PFIZER\BIONTECH,IM 917919,HI,37.0,M,"Rashes developed over many areas of the body (neck, ears, legs, chest, torso, groin) following the vaccine shot. The first rashes started to appear the evening after getting the shot and more appeared the days that followed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,MIL,None,None,None,,None,"['Blood test', 'Rash']",1,PFIZER\BIONTECH, 917920,CA,25.0,F,Swollen lymph nodes with lesions and blisters,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/18/2020,1.0,PVT,Aldactone,No,No,,No,"['Blister', 'Lymphadenopathy', 'Skin lesion']",1,PFIZER\BIONTECH, 917921,IL,34.0,F,"Left shoulder/arm muscle soreness Left pectoral muscle soreness Tender, swollen lymph node The pain in the Left shoulder and across Left chest is persistent and flares with exertion. Tender, swollen (presumed) lymph node directly under Left collar bone and to the left of sternum, pain persistent when at rest and flares when exerting force with Left arm (lifting/pushing/pulling), pain when taking deep breathes.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,PVT,"Remicade (q 8 weeks for Crohn's - last dose = 12/28/2020) Daily Wal-Fex (genenric Allegra) Daily Vitamin D3 (5,000 IU) Daily Biotin (8mg) Probiotic Host Defense Immune Support","Crohn's Disease, Alopecia, Dyshidrotic Eczema","Crohn's Disease, Alopecia",,none,"['Chest pain', 'Injection site pain', 'Lymph node pain', 'Lymphadenopathy', 'Musculoskeletal chest pain', 'Myalgia', 'Pain', 'Painful respiration']",1,PFIZER\BIONTECH,IM 917922,FL,44.0,M,Headache-dull/ site pain - at 12 hrs post injection Chills 18 hrs post injection Fever 38C - 30 hrs post Injection Significant fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,WRK,"Allegra, famcyclovier, Pepcid, Allegra, flax oil",None,HSV right cornea,,PCN,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 917923,FL,42.0,F,"Night of vaccine, headache. Next day, muscle and joint aches, shooting nerve pain in legs before getting out of bed some days. Low grade fever 12/30. On 12/31 felt normal. On 1/1 symptoms began to recur fever 101.3, with higher fever 101.6 1/2/2021 and 100.3 1/3/2021, on ibuprofen from morning each day. Chills and sweats daily. COVID19 rapid test 1/3/2021 is negative. Currently temp 100.3, muscle aches, dizziness and congestion continue, feels winded walking short distances.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/26/2020,0.0,PVT,none,none,none,,none,"['Arthralgia', 'Chills', 'Dizziness', 'Dyspnoea exertional', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Nasal congestion', 'Neuralgia', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 917924,TX,50.0,F,"Began with worsening of pain to injection site, then pain spread throughout arm. Shortly after began with body aches, chills and fatigue, then incontrollable shivering and fever of 101 F. Continue with fever next day and redness/swelling to arm, body aches. Low grade fever, fatigue and body aches continue through today (3 days), but feeling way better than before.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PUB,Atorvastatin 10 mg,None,Diverticulosis Hypercholesterolemia Cholelithiasis Seasonal Allergies,,Levoquin Peaches Nectarines Apricots,"['Chills', 'Erythema', 'Fatigue', 'Injection site pain', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 917925,AL,41.0,F,"Woke up with extreme leg aches and low grade fever, also noticed that my arm was really sore, swollen, red and hot to the touch. Took Tylenol and Benadryl. This continued from Wednesday-Saturday. On Sunday, I began feeling normal again, except that my arm is still sore, red, swollen, bruised, and hot to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,PVT,"Metoprolol, Topamax, Citalopram, Trelegy",No,,,No,"['Contusion', 'Erythema', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Skin warm']",1,MODERNA,IM 917926,FL,37.0,F,Splotchy red rash appeared at injection site 1 week post injection. No pain. Visibly swollen and warm to the touch. rash is 2x3 inches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/03/2021,7.0,WRK,"advil, melatonin",none,no,,none that i know of,"['Injection site erythema', 'Injection site rash', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 917927,CT,40.0,F,Day 8 red raised itchy. 3x3cm injection site reaction. Some tightness in the muscles as well.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,01/03/2021,8.0,PVT,Dyazide,Neg,No,,Knda,"['Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Muscle tightness']",1,MODERNA,IM 917928,CT,35.0,F,"Approximately 5-6 minutes after receiving vaccine, my left arm that was injected started to tingle and then suddenly I felt like I couldn?t breathe and had shortness of breath. The staff called a non-patient medical response and administered 0.3mg Epi. I was transported to the ER and received oxygen via nasal cannula, labs drawn, chest x-ray, soft tissue neck x-ray, IV Benadryl and Pepcid.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,Birth Control pill,,,,Lactose (mild abdominal discomfort),"['Chest X-ray normal', 'Dyspnoea', 'Laboratory test normal', 'Paraesthesia', 'Spinal X-ray normal']",1,MODERNA,IM 917929,PA,31.0,F,"Symptoms started today (Day 7 after vaccine)- swollen, redness, warmth, itchiness at site of injection with swollen painful lymph node in the left axilla which started on day 6 accompanied by some mild chills and body aches... started today and hasn?t changed with taking loratadine and Advil",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/03/2021,7.0,WRK,"Methimazole Birth control (progesterone only) Vitamin B, C,D Magnesium Fish oil Acetylcarnitine Probiotic CBD",,Graves? disease-hyperthyroidism Migraines,,No known,"['Axillary pain', 'Chills', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Lymphadenopathy', 'Pain']",1,MODERNA,IM 917930,OH,49.0,F,"24 hours post fever 101.0, chills, joint pain , muscle aches, and injection site pain/swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/28/2020,1.0,OTH,None,None,None,,None,"['Arthralgia', 'Chills', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 917931,NY,44.0,F,"Swelling (7x5 cm), erythema almost like urticaria and mild itching at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/02/2021,10.0,WRK,Levothyroxine,None,Migraine and Hypothyroidism,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria']",1,MODERNA,IM 917933,MD,57.0,M,Headaches two after injection and fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/25/2020,24.0,PVT,"Losartan, metoprolol, amlodipine, Viagra, Colace",None,Hypertension,,NONE,"['Fatigue', 'Headache']",1,PFIZER\BIONTECH,IM 917934,PA,36.0,F,"dizziness, flushing in face, and heart pounding (felt like she just got done running) pulse 100",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,none,productive cough for over one month,none,,none,"['Dizziness', 'Flushing', 'Heart rate increased', 'Palpitations']",1,MODERNA,IM 917935,NY,27.0,F,Three hours after getting vaccine had moderate left shoulder pain turning to severe. Woke up on the middle of the night with 10/10 pain and radicular symptoms down left arm with weakness in grip strength,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2020,01/02/2021,366.0,PVT,Birth control Sronyx,None,None,,None,"['Arthralgia', 'Grip strength decreased', 'Pain in extremity', 'Radicular pain']",1,MODERNA,IM 917936,FL,58.0,M,"Hives Left Ankle. Uncomfortably itchy. Starting morning after injection and still persisting 5+ days post. Itching has subsided, but required hydrocortisone and benadryl for 3+ days, and hives still presenting at 5+ days. Also itching and mild hives on palms and wrists of both hands, also treated with hydrocortisone.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,WRK,Atorvastatin 40 mg DAILY Breo Ellipta 100/25 DAILY Levothyroxine 0.05 mg QAM Metoprolol ER 25 mg DAILY Omeprazole 40 mg DAILY Singulair 10 mg QHS Tamsulosin 0.4 mg DAILY Olopatadine HCL 0.665 mcg DAILY Each Side ProAir 90mcg PRN Aspirin 81m,None,Asthma Acid Reflux Supraventicular Tachycardia Hyperlipidemia Hypothyroid Benign Prostatic Hyperplasia,,"Percocet (pruritis) Seasonal and environmental allergies (grasses, mold) Contact Dermatitis (gourds)","['Pruritus', 'Urticaria']",1,MODERNA,IM 917937,CT,37.0,F,"Immediately felt arms and legs go cold and tingling. Had trouble breathing with rapid heart rate. Subsidied after 20 mins but popped back up through the night in smaller instances. Day 2: sore arm, body aches muscle pains tingles- felt like vision was in HDR Day 3: fever 100 F, severe headache, body aches and tired overall felt weird Day:4 still feel weird/off, vision changes - have trouble seeing distance and focusing when prior had perfect 2020 vision",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PUB,None,None,Celiacs Anemia,,Keflex Latex Penicillin,"['Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Headache', 'Heart rate increased', 'Myalgia', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Peripheral coldness', 'Pyrexia', 'Visual impairment']",1,MODERNA,IM 917939,CA,56.0,F,BioNTech Covid-19 Vaccine I experienced sudden severe chills lasting 2-3 minutes. I also had extreme elevation of pain to my injured knee from a 5 to 10+ during this episode. The chills resolved spontaneously.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,"zyrtec, multivitamin",none,none,,none,"['Chills', 'Condition aggravated', 'Pain']",1,PFIZER\BIONTECH,SC 917940,NJ,29.0,M,"Shot received at 1pm. At 6 pm, started to experince severe chills, body aches and temp of 99.5. Of note, I have had covid in the past(March). I get antibodies tested regularly as I am in a study; antibodies still present. My symptoms following this vaccine were more severe than my covid symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,None,None,None,,None,"['Body temperature increased', 'Chills', 'Pain']",1,MODERNA,IM 917941,TX,66.0,M,"TINGLING IN EXTREMITIES AND TONGUE, TONGUE SWELLING, MILD HTN, TREATED FOR ALLERGIC RXN WITH DIPHENHYDRAMINE 25MG IM INJECTION AND MONITORED FOR SIGNS OF ADDITIONAL ALLERGIC RXN/ANAPHYLAXIS. S/S RESOLVED S/ DIPHENHYDRAMINE AND TIME. PT WAS ALSO MILDLY HYPOCAPNIC ON ETCO2 MONITORING AND STATED THAT S/S COULD BE DUE TO MILD ANXIETY.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,OTH,LOSARTAN,,,,,"['Anxiety', 'Hypersensitivity', 'Hypertension', 'Hypocapnia', 'Paraesthesia', 'Paraesthesia oral', 'Swollen tongue']",1,MODERNA,IM 917943,,47.0,F,Area of redness and swelling around injection site with slight itching,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/03/2021,7.0,WRK,"MVI, Vitamin D and C supplements",,,,Minocycline,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 917945,MT,42.0,F,"Day 1: Soreness and pain in arm where injection was given, chills, and body aches Day 2: Soreness and pain in arm where injection was given, chills, body aches, fever of 101.3 Day 3: Soreness and pain in arm where injection was given Day 4: No symptoms noted",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,None,None,None,,Penicillin,"['Chills', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 917946,IN,29.0,F,Throat tightness Hot Dizzy Nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,None,None,None,,Penicillin and Ceclor,"['Dizziness', 'Feeling hot', 'Nausea', 'Throat tightness']",1,PFIZER\BIONTECH,SYR 917947,IN,35.0,F,Moderate headache that will not go away no matter what medications are taken.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,Aplenzin 174mg bd Vit C 1000mg bd Vit B complex bd Vit D 50000u weekly,-,Asthma,,Trintellix,['Headache'],1,PFIZER\BIONTECH,IM 917948,CO,42.0,F,"Arm soreness for <24hrs immediately after injection with no further s/s until 1 week later when presented with localized allergic rxn- swelling, erythema, itching, heat to deltoid area apreading down to bicep over the next 24hrs. Treated with daily low dose benadryl x 4 days so far with decreased s/s",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,OTH,fish oil,,migraines,,,"['Erythema', 'Feeling hot', 'Hypersensitivity', 'Immediate post-injection reaction', 'Local reaction', 'Pain in extremity', 'Peripheral swelling', 'Pruritus']",1,MODERNA,IM 917949,TX,64.0,F,"Moderna COVID-19 Vaccine EUA Started a fever around 10:30 p.m., chills, headache and nausea. Fever broke around 3:30 a.m. on 1/3/2021. Sweated out of clothes Took Acetaminophen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PUB,Amitriptyline 25 mg x2 Low dose aspirin Fenofibrate 145 mg Magnesium 400 mg Nasacort D3 B12 Zertac Melatonin,,Fibromyalgia,,Sulphur and Penicillin,"['Chills', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pyrexia']",1,MODERNA, 917950,GA,44.0,F,"rash to torso, back and arms the next day following the vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,OTH,multivitamin,none,none,,none,['Rash'],UNK,PFIZER\BIONTECH, 917951,TX,45.0,F,After the shot I sat down and waited for 15 minutes and about 12 minutes a felt flushed and my pulse went night around 119 beats per minute and my blood pressure went high to 150 over 99 .. my sugar jumped to 149 and I got so clammy .. it lasted a good 25 minutes I kept checking my o2 and my pulse finally it went down and I was so tired.. I went home and I was fatigue for 5 days .. I don?t know if I should get the second dose after my heart raced,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,SEN,,None,Diabetes,,Pcn Marcobid,"['Blood glucose increased', 'Blood pressure increased', 'Cold sweat', 'Fatigue', 'Flushing', 'Heart rate increased', 'Palpitations']",1,PFIZER\BIONTECH,SYR 917952,CA,49.0,F,"2:37 pm 10 minutes after receiving vaccine pt reports feeling dizzy and nervous. She has a history of anxiety and has been seen before for anxiety attacks. Pt denies chest pain, shortness of breath or pain. 2:45 pm pt evaluated by EMS BP 138/78, Pulse 98. pt reports feeling better. 2:55 pm pt declined transport to ED, signed out AMA. Pt was escorted out to car.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PUB,Trazadone,none,Anxiety,,none,"['Dizziness', 'Nervousness']",1,PFIZER\BIONTECH,IM 917953,NY,27.0,M,"Chills, Abdominal Pain (Upper)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,PVT,Biotin Vitamins,None,"Diverticulosis, Minor Inferior Repolarization Disturbance (Cardiac)",,Augmentin,"['Abdominal pain upper', 'Chills']",1,MODERNA,IM 917954,IL,37.0,F,Nausea Joint pain Chills Muscle pain Headache Tiredness Injection site pain Vomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,"Gabapentin, Fluoxetine, birth control",Cleared from Covid 19 on 11/28/2020,Chronic headaches OCD,,Penicillin,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,SYR 917955,AZ,55.0,F,"25 minutes after receiving the injection, there was a sudden onset of facial swelling, hives, itching and airway constriction. I had already left the drive-thru vaccination clinic and was driving to the hospital emergency room where I work. I informed my colleagues of my symptoms and was treated for anaphylaxis with IV diphenhydramine and famotidine over several hours. I was given a prescription for a prednisone taper for the next 6 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,OTH,"Albuterol metered dose inhaler as needed Meloxicam 15 mg, once daily Loratadine 10 mg once daily Famotidine 20 mg as needed Acetaminophen 500 mg as needed",None,Asthma (controlled) Arthritis,,"Allergic to various grasses and pollens, cat dander, newspaper ink No known allergies to food or medications","['Anaphylactic reaction', 'Pruritus', 'Swelling face', 'Throat tightness', 'Urticaria']",1,PFIZER\BIONTECH,SYR 917956,TN,55.0,F,"7 days after vaccine, a red, swollen, warm, hard rash appeared on right arm. It quickly spread to cover upper arm. Went to urgent care facility Received Rocephin shot and steroid shot Sent home on Prednisone 4mg dose pack (21 total) and 7 days of Amoxicillin 500 mg twice a day",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/30/2020,7.0,PVT,None,None,None,,Avocado,"['Induration', 'Peripheral swelling', 'Rash erythematous', 'Skin warm']",1,MODERNA,IM 917957,NY,34.0,F,"Approximately 1 week following vaccination, patient developed new onset of right sided hemisensory loss and paresthesia with feeling of mild vertigo. This worsened over the following 4-5 days prompting patient to come to hospital on January 3, 2021 for further evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,,10/04/1986,12/28/2020,12504.0,PVT,None,None,None,,Sulfa Drugs:,"['Acute disseminated encephalomyelitis', 'CSF test', 'Magnetic resonance imaging', 'Paraesthesia', 'Sensory loss', 'Vertigo']",1,PFIZER\BIONTECH,IM 917958,IN,42.0,M,"Chills, fever up to 101.7, headaches, some body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,Arnuity,None,Asthma Was hospitalized for covid pneumonia in March 2020,,Walnuts,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,SYR 917959,CA,30.0,F,About an hour after receiving Vaccine patient began to have a headache with photophobia as well as nausea and then later vomiting. She did take her migraine meds and Tylenol in the next few hours. However continue to have vomiting overnight and also fevers to 102. The next day about 24 hours after vaccine she continue to have nausea and headache. Took her second dose of migraine medication and will take Zofran for vomiting. She is able to keep fluids down.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,,COVID-19 asymptomatic case. 12/8/2020 positive test,"Migraines, lupus",,Honey,"['Headache', 'Nausea', 'Photophobia', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 917960,TX,42.0,F,"Moderna COVID?19 Vaccine EUA 18 hours after receiving vaccine, I experienced muscle and joint soreness all over the body with continued mild soreness at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,PUB,Lexapro,None,None,,No known allergies,"['Arthralgia', 'Injection site pain', 'Myalgia']",1,MODERNA,IM 917961,CA,54.0,M,"I suffer from lingering SOB with exertion after COVID infection. On the night of 12/31/2020 I began to feel more SOB than usual and was unable to correct my SOB with rescue inhaler. Became more SOB with exacerbated tachycardia and tachypnea, My family had to call 911 because I became aphasic and showing signs of possible stroke. I was taken to the ER and admitted for respiratory recovery and to role out stroke. The stroke was ruled out and I recovered with IV prednisone therapy, twice daily and supplemental oxygen. Released after HR, BP, & respiratory effort returned to normal: 01/03/2021",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,Symbicort inhaler: 2-puffs / twice daily Metoprolol 25mg: 1-tab / daily Lipitor 80mg: 1-tab / daily Zestril 5mg: 1 tab / daily Brilinta 90mg: 1-tab / twice daily Prilosec 20mg: 1-tab / daily HCTZ 25mg: 1-tab / daily ASA 81mg: 1-tab / daily,"June 22,2020: COVID19 positive July 2020: Diagnosed with restrictive airway disease, small airway disease, lung nodules November 11, 2020: STEMI, required angioplasty and stent placement",HTN Conditions highly related to COVID19 infection per provider: Restrictive airway & small airway disease CAD Depression Anxiety,,Losartan,"['Angiogram cerebral', 'Aphasia', 'Arteriogram carotid', 'Blood magnesium', 'Blood thyroid stimulating hormone', 'Brain natriuretic peptide', 'C-reactive protein', 'Chest X-ray', 'Computerised tomogram head', 'Culture urine', 'Differential white blood cell count', 'Dyspnoea', 'Dyspnoea exertional', 'Electrocardiogram', 'Fibrin D dimer', 'Full blood count', 'Glycosylated haemoglobin', 'Lipids', 'Magnetic resonance imaging brain', 'Metabolic function test', 'Perfusion brain scan', 'Platelet count', 'Red blood cell sedimentation rate', 'Respiratory viral panel', 'SARS-CoV-2 test', 'Scan with contrast', 'Tachycardia', 'Tachypnoea', 'Troponin I', 'Ultrasound kidney', 'Urine analysis']",1,MODERNA,IM 917962,NV,54.0,F,"5pm 12-29-2020 slight headache, that lasted through Wednesday evening, 12-30-2020. Thursday, 12-31- 2020, no adverse reaction. Friday, 1-1-2021 , entire body, including internal organs were trembling. Saturday, 12-31-2020, extremley dizzy, unable to stand, function. Nauseated, extremely dehydrated, extreme exhaustion. This lasted 24 hours. Sunday, 1-3-2020, still exhausted, but not to extreme. All other symptoms have subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Omeprazole, Furosimide, Folic Acid",None,Rheumatoid Arthritis,,Penicilin,"['Dehydration', 'Dizziness', 'Dysstasia', 'Fatigue', 'Headache', 'Nausea', 'Tremor']",1,PFIZER\BIONTECH,IM 917963,CA,50.0,F,"Moderate to severe left arm pain. for 12 days now post first covid vaccine shot. Mild neck stiffness also noted. The worse pain on left arm felt on first day, then slowly got better after. However still with Limited mobility (my left arm movement very guarded due to feeling of soreness on the affected arm), stiffness on left arm. Ice pack, advil and tylenol, and sometime with cyclobenzaprine, which I thought would help, but did not help.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,"advil, tylenol,cyclbenzaprine",none,none,,codeine,"['Mobility decreased', 'Musculoskeletal stiffness', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 917964,TX,61.0,F,"Post vaccine day 7, ""quarter-size"" red area; on day 8, approx. 3 inches in diameter, red, warm, slightly tense, itchy. No lymphadenopathy, no fever. Telehealth visit",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,PUB,"Losartan, Xanax 1 mg prn, OTC topical cortisone",None,"HTN, ""parathyroid disease,"" PTSD",,NKDA,"['Erythema', 'Pruritus', 'Skin warm', 'Tension']",1,MODERNA,IM 917965,NY,41.0,F,"15 min after vaccine, I felt dizzy and lightheaded. 2 hours after vaccine, I felt nauseous and lost my appetite The following morning I felt like I had been run over by a truck. I had a low grade fever of 99.9 that went up to 100.0 measured by ear thermometer I had joint pain and over all muscle pain By the evening I had mucous in nose, post nasal drip and slight difficulty breathing. I took 2 advils which relieved the fever and body aches On Saturday and into Sunday, I continue to have an over arching malaise, I do not feel healthy. I feel like my body is fighting something, I developed a slight sore throat and my head feels heavy and foggy. I've continued to take advil.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,None,None,None only amenorrhea,,None only cats,"['Arthralgia', 'Decreased appetite', 'Dizziness', 'Dyspnoea', 'Feeling abnormal', 'Head discomfort', 'Malaise', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'Rhinorrhoea', 'Upper-airway cough syndrome']",1,MODERNA,IM 917966,CA,30.0,F,"Hard,swollen area at injection site. Denies redness, swelling or warmth or rash. Noticed 7 days post injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,01/02/2021,6.0,OTH,nONE,None known,None known,,No Known Allergies,"['Injection site induration', 'Injection site swelling']",1,MODERNA,IM 917967,NV,54.0,F,"Tingling feeling like I'm being stuck with pins/needles over my body- hands, fingers, feet, toes, arms, legs, lips, face, mouth. Started Friday morning January 1st 2021. I went to the ER on Friday January 1st 2021 and was given Prednisone. I'm still having symptoms today Sunday January 3rd 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,SCH,None,"High Blood pressure , osteoarthritis",None,,Sulfa,"['Blood test normal', 'Chest X-ray normal', 'Electrocardiogram normal', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,SYR 917968,AZ,41.0,F,"Sore arm, diarrhea, low grade fever. No treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,UNK,"Vitamin C, Vitamin D, omega 3, women?s multivitamin",,,,,"['Diarrhoea', 'Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 917969,IL,22.0,F,"I received the 2nd dose of vaccine around 2pm on 01/02/21, was feeling fine until around midnight/1 am I felt chills and feverish but had a temp of 98.8 at that time, woke up around 4am with body aches, chills, fatigue, and a temp of 102.3. I was fine with these symptoms as I knew they were common side effects until my heart rate spiked from about 60 to the 160s and I began to have a throbbing headache. I could not get my heart rate to come down, I was calm and knew it was not anxiety so I went to the ER where they did blood tests, EKG, UA and gave me fluids. Everything came back normal but my heart rate continued to be elevated around 130s for a couple more hours, finally came down to about 100-110, HR is still slightly elevated and I still have a fever of 100.4 and migraine",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/03/2021,1.0,PVT,Rizatriptan (PRN) Aerovela (BCP),None,Anemia IBS Migraine w/o aura,fainted after the HPV vaccine in July 2020,No,"['Blood test normal', 'Chills', 'Condition aggravated', 'Electrocardiogram normal', 'Fatigue', 'Headache', 'Heart rate increased', 'Migraine', 'Pain', 'Pyrexia', 'Urine analysis normal']",2,PFIZER\BIONTECH,SYR 917971,TN,42.0,F,"3"" X 3.5"" raised, red, swollen, tender.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,SCH,,,"Asthma, Supravenricular Tachycardia",,"Morphine, Lysol","['Rash erythematous', 'Swelling', 'Tenderness']",1,MODERNA,SYR 917972,WA,34.0,F,15 minutes post vaccination administration I developed tingling of the tongue and bilateral arms. I also had an increase in heart rate from 70 to 130. I felt a pounding in my chest. It felt difficult to talk to due tingling of the tongue. I took Benadryl 25 mg PO 30 minutes prior to vaccine due to history of anaphylaxis with shell fish.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Benadryl 25 mg PO 30 minutes prior to administration due to known severe shell fish allergy,None,None,,"Anaphylaxis to shellfish Allergy to tree nuts (rash, itching)","['Chest discomfort', 'Heart rate increased', 'Paraesthesia', 'Paraesthesia oral']",1,MODERNA,IM 917973,CO,45.0,F,Chills headache nausea vomiting still vomiting and nausea five days later,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,"Ibuprofen, thyroid np, ambian",None,Back problems heartburn hypothyroidism,,None,"['Chills', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,SYR 917974,AZ,31.0,F,"Major headache, swelling and redness and soreness on arm, severe rash around lips",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,SEN,None,COVID19 infection on 11/6/2020,,,,"['Cheilitis', 'Erythema', 'Headache', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,SYR 917975,TX,51.0,F,Hives - Benadryl,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"Hives on face, lip and hands",None,Sjogrens,,Sulfa,['Urticaria'],1,PFIZER\BIONTECH,SYR 917976,CA,41.0,M,"My entire body felt really cold for the whole day on Tuesday. I couldn't get warm and had to put on extra clothing during the day and extra blankets when I went to sleep. I think this is considered to be chills. On both Tuesday and Wednesday, I ran out of energy by the afternoon. On both Tuesday and Wednesday, my head felt heavy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,Daily vegan multivitamin,None known.,Mental fatigue and body fatigue since approximately 2013,I got really sick after the first time I had the influenza vaccine shot. This occurred in 2013. I feel like I usually don't feel,None,"['Asthenia', 'Chills', 'Feeling cold', 'Head discomfort']",1,PFIZER\BIONTECH,SYR 917977,NJ,61.0,M,"Chills, body aches, headache, BP increased, pulse increased, lightheadedness, sweats the day after the vaccine. (The evening and the whole night.)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,"finasteride, lexapro.",,BPH,,"amoxicillin, Bactrim","['Blood pressure increased', 'Chills', 'Dizziness', 'Headache', 'Heart rate increased', 'Hyperhidrosis', 'Pain']",1,MODERNA,IM 917978,TN,36.0,F,"First ever complex migraine with aura including right visual field deficits, tingling of the right hand and and right side of the mouth and difficulty speaking over the course of an hour that then resolved and was followed by a severe migraine headache when nausea. My migraines have never been associated with aura, paresthesias, etc., before.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Claritin, Tylenol, Motrin",Viral URI (COVID-19 negative) with sore throat and cough that started 5 days prior to the vaccination.,Occasional migraines,,Latex sensitivity,"['Migraine with aura', 'Nausea', 'Paraesthesia', 'Paraesthesia oral', 'Speech disorder']",UNK,MODERNA,IM 917979,TX,59.0,F,"At 8:30 pm on 1/1/2021, I began to have right side pain in my back under rib area. Pain was pretty intense and I took 2 Extra Strength Tylenol 500 mg and went to bed. I had a restless night and pain continued until1:30 pm on 1/2/2021 when it subsided. I don?t know if it was related to vaccine. I don?t know if it was kidney pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PHM,None,None,Stage 2 kidney disease,,None,"['Back pain', 'Sleep disorder']",UNK,MODERNA,SYR 917980,CT,53.0,F,"I noticed swelling of the lymph nodes under my left armpit, when i called my doctor's office the nurse told me to put ice for 20 minutes. Ice was applied every day for 20 minutes, the swelling finally went down some today but the vein under my left arm is still tender.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,WRK,Multivitamins,No known illness at the time of vaccination.,No chronic health conditions.,,No Known allergies,"['Lymphadenopathy', 'Tenderness']",UNK,PFIZER\BIONTECH,SYR 917981,CA,31.0,F,Left arm pain at injection site x 3 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,None,None,Nobr,,None,['Injection site pain'],1,MODERNA, 917983,MI,22.0,F,Swelling and sensitivity around eyes. Eczema flare up around eyes. Mild dizziness and general malaise.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PVT,"Humalog, Lexapro, vitamin D, vitamin C, oral birth control",,"Type 1 Diabetes, celiac disease",,"Pineapple, penicillin, keflex","['Dizziness', 'Eczema', 'Malaise', 'Periorbital swelling', 'Sensitive skin']",1,PFIZER\BIONTECH,IM 917984,CA,28.0,F,"S: At 1557 patient c/o tongue swelling and itchiness. Given 25mg PO benadryl at 1557 � O: Patient alert and oriented, airway patent. BP 129/88 HR 74 O2 98% 1617 Repeat O2 sat 98% HR 59. Patient c/o persistent tongue swelling. � A/P: 28 F with history of nut allergy with tongue swelling after Pfizer vaccine. EMS notified 1620. Patient evaluated by EMS and declined further treatment by EMS and stated that she would walk over to ED for further evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,WRK,fluoxetine,unknown,unknown,,dustmites,"['Pruritus', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 917985,MO,27.0,F,"Pt reports she has had an increased heart rate in the 110-120s for the past three days after receiving the COVID19 vaccination. Pt reports increased dizziness today, nausea, and in the past hour some chest tightness. Pt also reported recent travel to and from out of town, about 14 hours travel time in the past week and half. Pt given fluids, ruled out for illness and PE. Pt improved with fluids.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,Lo Lestrin Fe; nortriptyline; paxil; wellbutrin SR,None,Anxiety; IBS; and Depression,,SULFA,"['Angiogram pulmonary normal', 'Blood test normal', 'Chest X-ray normal', 'Chest discomfort', 'Computerised tomogram thorax', 'Dizziness', 'Electrocardiogram normal', 'Heart rate increased', 'Nausea', 'Pregnancy test urine negative', 'Urine analysis normal']",1,PFIZER\BIONTECH,IM 917986,IN,33.0,F,"Per internal reported event: COVID vaccine (Pfizer) given 12/29/20 1440. Hx reactions to vaccines. started c/o throat tightness 1450, given 50mg Benadryl PO. Pt reports sx resolved at 1515. Pt went home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/03/2021,5.0,PVT,,,,,,['Throat tightness'],1,PFIZER\BIONTECH,IM 917987,GA,65.0,M,High fever continues into second day severe chills body aches constant headache and cannot sleep,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,Atenolol Levothyroid Lorazepam Tylenol,Hypertension Low thyroid Peripheral neuropathy,See above,,None that I am aware,"['Chills', 'Headache', 'Pain', 'Pyrexia', 'Sleep disorder']",1,PFIZER\BIONTECH,SYR 917988,NM,32.0,F,"Left arm soreness and weakness for the first two days. Nausea, vomiting, chills lasting from 2pm the day following the vaccine until the next morning",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/02/2021,1.0,UNK,"Propranolol, Lexapro, mirena",N/a,Migraine,,N/a,"['Chills', 'Muscular weakness', 'Nausea', 'Pain in extremity', 'Vomiting']",UNK,MODERNA,IM 917989,WA,47.0,F,"Day 8- New local erythema, itching at injection site. L arm 2"" X 3"" area. Past V-Safe.cdc check in.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/01/2021,6.0,WRK,None,None,None,,Bee stings-mild to moderate reactions,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 917990,MN,29.0,F,"12 hours after first dose, had extremely painful and swollen R lymph cervical node and fatigue. Continued for three days. On 12/25 awoke with painful gums, fevers of 102.1, chills in addition to symptoms. 12/26 had sore throat and worsening sores on tongue. Went to urgent care that morning, was tested for Covid, strep, influenza, RSV. All negative. Had overwhelming fatigue. 12/27 worsening tongue sores and thrush, had another appointment where given nystatin. At this appointment was diagnosed with an immune over response to the COVID-19 vaccine. The thrush still was not improving and extremely painful. Was started on Fluconazole for 14 days after another appointment on 12/29. No history of thrush, have good oral hygiene and follow all recommendations to prevent thrush with my inhaler. I lost 12 pounds due to the thrush and the extreme discomfort. Fever went away 8 days after vaccine dose, still have lingering thrush symptoms and R lymph node slightly enlarged.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,WRK,"Advair since age 6, once or twice a week.",None,Mild Asthma,,Nka,"['Candida infection', 'Chills', 'Fatigue', 'Full blood count normal', 'Gingival pain', 'Glossodynia', 'Influenza A virus test negative', 'Lymph node pain', 'Lymphadenopathy', 'Metabolic function test normal', 'Oropharyngeal pain', 'Pyrexia', 'Respiratory syncytial virus test negative', 'SARS-CoV-2 test negative', 'Streptococcus test negative', 'Tongue ulceration', 'Type III immune complex mediated reaction']",1,PFIZER\BIONTECH,IM 917991,CT,25.0,M,"Injection site tenderness: Started at 2 hours post vaccine, lasted approximately 48 hours Malaise: started at 4 hours post vaccine, lasted approximately 20hours Low-grade fever: started at 12 hours post vaccination, lasted approximately 12 hours Treated successfully with acetaminophen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Injection site pain', 'Malaise', 'Pyrexia']",1,MODERNA,IM 917992,IN,33.0,M,"Per internal reported event: COVID vaccine given 12/29/20 1500. Pt reports dizziness and feeling hot at 1515, diaphoretic. Vaso-vagal response. Assisted pt to wheelchair, given water and cool compress. Pt was monitored for an additional 15 minutes, and ambulated home with steady gait at 1534.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Dizziness', 'Feeling hot', 'Hyperhidrosis', 'Presyncope']",1,MODERNA, 917993,UT,63.0,M,"Hives on arms, legs, trunk 3 days after (started 1/2/21) vaccination. Itching controlled with Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,01/02/2021,32.0,PUB,"Fexofenadine, Omeprazole, tamulosin, minoxidil, synthroid, Vitamin D, dutasteride",None,"Hypothyroidism, BPH, GERD",,None,"['Pruritus', 'Urticaria']",1,MODERNA,IM 917994,CO,72.0,M,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/01/2021,01/03/2021,2.0,WRK,,,,,,['Unevaluable event'],UNK,MODERNA, 917995,,31.0,F,Moderna COVID-19 Vaccine Noticed a slightly raised warm red rash at area of injection site that expanded with a central clearing the next day then on the following day began to improve based on the marked area.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/30/2020,7.0,UNK,,,,,,"['Injection site reaction', 'Injection site warmth', 'Rash erythematous', 'Rash papular']",UNK,MODERNA, 917996,KS,48.0,F,"Weakness, tremors, fatigue, muscle pain, joint pain, scratchy throat, headache, neck and back pain, nausea, chills, heart racing/pounding, difficulty catching my breath",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,"Metformin, levothyroxine, sertraline, trimethoprim, hydroxezine, tizanidine, unisom, pantaprazole, famotidine, tamsulosin, probiotic, multivitamins, turmeric, montelukast, tylenol","Two weeks of a virus between 12/15 and 12/25 as well as a sinus and ear Infection still ongoing at time of vaccination. In prior month, flare up of Mast Cell Activation Disease.","Mast Cell Activation Disease, Fibromyalgia, Polycystic Ovarian Disease, Osteoarthritis, Degenerative Spine, mild Chiari Malformation, Hypermobility",Influenza vaccine with preservatives,"Food allergies, general allergies (indoor and outdoor), penicillin, amoxicillin, IV morphine","['Arthralgia', 'Asthenia', 'Back pain', 'Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Neck pain', 'Oropharyngeal discomfort', 'Palpitations', 'Tremor']",1,MODERNA,IM 917997,IN,39.0,M,"Low grade fever, body aches, one episode of vomiting, slight headache and eye sensitivity Swabbed 12/31/2020 COVID positive 1/2/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/30/2020,8.0,PVT,"Celebrex, Prestiq, Claritin",No,No,,No,"['Headache', 'Pain', 'Photophobia', 'Pyrexia', 'SARS-CoV-2 test positive', 'Vomiting']",1,PFIZER\BIONTECH,SYR 917998,,52.0,M,Slight soreness at site of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,UNK,,,,,,['Injection site pain'],UNK,MODERNA,IM 917999,AZ,33.0,F,"Within the first 12 hours I developed a fever of 102 - 103 degrees farenheit and chills with headache and substantial fatigue. The chills went away after the first day. The 2nd day I still had a fever. Day 3 I had significant nausea in conjunction with headache. These symptoms have continued from days 4 - today, day 11 post vaccine. While they are improving, after the initial fever/ chills my symptoms translated to into seemingly hormonal with nausea, strong food aversions, headaches (that felt hormonal) and 4+ days with substantial constipation and fatigue. It has mirrored the sickness I experienced with both pregnancies however I am not pregnant. I am still experiencing a mixture of fatigue, headaches, nausea and food aversions (food still does not taste normal).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,SCH,"Probiotic, omega 3.",None.,None.,"Sulfates, teenager, rash","Allergic to shellfish, onions, sulfates.","['Chills', 'Constipation', 'Fatigue', 'Food aversion', 'Headache', 'Illness', 'Nausea', 'Pyrexia', 'Taste disorder']",1,PFIZER\BIONTECH,IM 918000,IN,71.0,M,"Per internal reported event: COVID Vaccine 12/30/20 @ 0940. reported feeling hot and unsteady 0948. assisted pt to wheelchair, given water. Monitored and offered to take to ED, pt declined. Reports sx resolved and ambulated home with steady gait at 1003.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Balance disorder', 'Feeling hot']",1,MODERNA, 918001,CA,34.0,F,"At 1606 Patient reporting lightheadedness, bilateral hand tingling and numbness. Also reporting generalized headache 6/10. States that she has not eaten any food today except coffee. BP 88/49. HR 45 Patient was laid flat and legs elevated. Repeat BP 1613 101/59. Patient reported bilateral arms feeling ""cold"". � O: Patient alert and oriented, following commands, no focal weakness. BUE cool to touch. � EMS called at 1609. ED arrival 1620. Repeat VS 1620 105/65 HR 55 � Upon EMS arrival patient declined to receive further treatment and signed AMA paperwork. � Discussed with patient to return to ED for any further worsening of symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,WRK,unknown,unknown,unknown,,unknown,"['Blood pressure decreased', 'Dizziness', 'Headache', 'Heart rate decreased', 'Hypoaesthesia', 'Paraesthesia', 'Peripheral coldness']",1,PFIZER\BIONTECH,IM 918002,CA,37.0,F,"Tenderness and swelling of left cheek at site of cosmetic filler (Juvederm Voluma, injected October 2018) starting within 30 minutes of first Moderna COVID-19 vaccine dose. Resolved fully within 48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Nutrafol hair supplement,None,None,,None,"['Swelling face', 'Tenderness']",1,MODERNA,SYR 918003,FL,22.0,F,"Single hive rash, about 2.5 inches in length, appeared on deltoid where injection took place exactly 5 days after initial dose of the Moderna COVID-19 Vaccine EAU. Rash will dissipate and reappear 1-2 times daily since initial formation. Very itchy. Exclusive to the deltoid muscle where the vaccine was injected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/29/2020,5.0,PVT,"Omeprazole, multi vitamin",,,,,"['Injection site pruritus', 'Injection site rash', 'Injection site urticaria']",1,MODERNA,IM 918004,,46.0,F,Slight dizziness that lasted for 5 minutes and resolved spontaneously.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,UNK,,,,,,['Dizziness'],UNK,MODERNA,IM 918005,OR,40.0,F,"Pt developed racing heart rate about 5 minutes post injection. HR jumped as high as 156 recorded, stayed high for a few minutes then went back to normal. Over then next 30 minutes had multiple episodes of her HR jumping up again and then going back to normal. Pt received a dose of benedryl to treat symptoms. Pt monitored for 1 hour at which time she was felt to be stable. Pt provided with instructions to go to ER if symptoms reoccur.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,PVT,"TRI-SPRINTEC (28) 0.18/0.215/0.25 MG-35 MCG (28) ORAL TAB, Sig: Take 1 tablet by mouth daily ONDANSETRON 4 MG ORAL RAP DIS TAB, Sig: Dissolve 1 tablet by mouth every 8 hours as needed for nausea or vomiting STELARA 90 MG/ML SUBQ SYRINGE,",,ACNE CROHNS DISEASE. ECZEMA CROHNS DISEASE OF SMALL INTESTINE LONG TERM USTEKINUMAB THERAPY,,"? Adalimumab Skin reaction ? Infliximab TACHYCARDIA , CHEST RED, EYES BLOOD SHOT ? Vedolizumab Tachycardia","['Electrocardiogram', 'Heart rate increased', 'Palpitations']",1,MODERNA,IM 918006,TN,43.0,F,"Sever muscle aches and joint pain, headache radiating down into neck 6/10, sore throat, pain at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,WRK,,,,,Seasonal Allergies,"['Arthralgia', 'Headache', 'Injection site pain', 'Myalgia', 'Neck pain', 'Oropharyngeal pain']",1,MODERNA,IM 918007,WI,52.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for a few seconds it - did not go past 15 minute observation. Felt nauseated for a brief time - did not go past the 15 minutes. About 25 minutes after the tip of my tongue, section of my bottom lip and sides of my tongue were tingly. The tip of my tongue continues to be like that day #2 after and there is a small blood blister underneath the tip of my tongue. Parts of my body feel a little itchy an hour after vaccine and continues very infrequently at this time and it disappears in seconds.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,OTH,bisoprolol crestor aspirin choline pregnenolone magnesium,none,high cholesterol dysautonomia cardiac arrythmia,,"bleach, strong smells, essential oils, perfumes, cleaning products","['Angioedema', 'Chest pain', 'Dyspnoea', 'Nausea', 'Paraesthesia oral', 'Pruritus', 'Tongue blistering']",UNK,PFIZER\BIONTECH,SYR 918008,IN,39.0,F,"Per internal reported event: Received the following information from patient via email to Dr.: ""Yesterday morning at about 7:20am, I received my first dose of the Moderna COVID vaccine at Hospital. I waited 15 minutes in the lobby, felt fine, and left. While I was still driving, about 7:45am, I noticed that it had become difficult to swallow. My throat felt swollen. I decided to stay close to the hospital, and ended up driving to Pharmacy and taking 50 mg benedryl and 400 mg ibuprofen at 8:00am. I called my primary care provider and left a message, and decided to go to work (started at 9am). I took another 50 mg of benedryl at noon. My provider called me early in the afternoon, and was unable to give me advice. He recommended contacting Hospital (vaccine clinic). I experienced chills in the afternoon, and after I left work at 3pm, I took another 400 mg of ibuprofen, a hot shower, and slept for 3 hours. I felt much better after the nap. I reported all of this to the CDC yesterday afternoon through their ""check-in"" feature.""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Chills', 'Dysphagia', 'Pharyngeal swelling']",1,MODERNA, 918009,NC,44.0,F,The night of vaccination I had some mild soreness in my arm and then developed rigors at 2am on 12/31/20. Throughout the day on 12/31 I had a low grade temp (99.5) and felt poorly. My arm soreness progressed for 1-2 more days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/31/2020,30.0,PUB,Zyrtec Nuvaring,None,Migraines,,None,"['Chills', 'Feeling abnormal', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 918010,NH,54.0,F,"Patient was seen in ER on January 3, 2020. Started on January 2, 2021 she developed chills, and shaking. Noted itching at site and a welt like raised area at site of injection. Patient was treated with anti-histamine for pruritic symptoms. She had no fever, no cough, no pain at site, or any other symptoms. Vital signs were normal 98.3 temp, HR 85, blood pressure 163/87, resp 18 oxygen sat 99%.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,01/02/2021,9.0,OTH,None reported,none,none given,,"Cipro, Oxycodone, Amoxicillin,","['Chills', 'Injection site mass', 'Injection site pruritus', 'Tremor']",1,MODERNA,IM 918011,WA,33.0,F,Swelling and pain with large red cicely on deltoid where shot administered. I did not have symptoms post shot as described . This started today and my arm hurts and fingers feel swallen. Also pain goes into my left shoulder and axillla,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,01/03/2021,10.0,PVT,,No,No,,No,"['Arthralgia', 'Axillary pain', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Pain in extremity', 'Peripheral swelling']",UNK,MODERNA, 918012,NV,45.0,M,Acute onset of vertigo nausea and vomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PVT,Amlodipine-benzapril Rosuvastatin Omeprazole,None,Hypertension Dyslipidemia,,None known,"['Nausea', 'Vertigo', 'Vomiting']",1,MODERNA,IM 918013,NY,27.0,F,"Large approximately 5 cm in diameter hive with redness and itching that showed up roughly a week after receiving the vaccine, at the injection site. It resolved after 2-3 days without any intervention.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/29/2020,6.0,PVT,Zoloft,None,Depression and anxiety,,"Environmental/seasonal allergies, no other food or drug allergies","['Injection site erythema', 'Injection site pruritus', 'Injection site urticaria']",1,MODERNA,IM 918014,PA,42.0,M,"Lightheaded with low heart rate 50-60 bpm for 60 minutes post vaccination. Even with hydration and food, took 60 min to clear. No syncopal episode. Blood pressure measured normal (120-140 systolic).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,None,None,None,,None,"['Dizziness', 'Heart rate decreased']",1,MODERNA,IM 918015,TX,62.0,F,"9 DAYS POST VACCINATION EXPERIENCED SORE THROAT, MILD DRY COUGH, CHILLS W/O FEVER, GENERALIZED FLU LIKE MUSCLE ACHES.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/31/2020,9.0,PVT,,,,,,"['Chills', 'Cough', 'Influenza like illness', 'Myalgia', 'Oropharyngeal pain', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,IM 918016,ND,40.0,F,"Axilla lymph node swelling with tenderness and soreness 6 days post vaccine. No other symptoms. Initial symptoms after receiving the covid vaccine was slight numbness and tingling of left arm where injection was. This resolved within the first hour. However, did have some left neck soreness and ache, as well as injection site soreness in left arm for three days",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/03/2021,6.0,UNK,none,none that I know of. no illness symptoms,none,,penicillin allergy,"['Injection site hypoaesthesia', 'Injection site pain', 'Injection site paraesthesia', 'Lymph node pain', 'Lymphadenopathy', 'Neck pain']",1,PFIZER\BIONTECH,IM 918017,MO,39.0,F,"Pharmacy was informed by the Director of Nursing at the long-term care facility where the vaccine clinic was held that one of their staff members had been diagnosed with bursitis. No other specific information was known/provided. (For Item # 21 below - we believe the patient saw a healthcare professional who diagnosed their bursitis, but we do not know for certain).",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,SEN,,,,,Hydrocodone/acetaminophen = itching,['Bursitis'],1,MODERNA,IM 918019,TX,32.0,F,Rash and small red bumps on facial cheeks and neck that itch and feel irritated if I put on moisturizer on my face.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/01/2021,4.0,PVT,Vitamins,None,None,,NKDA,"['Rash', 'Rash erythematous', 'Rash pruritic', 'Skin irritation']",1,PFIZER\BIONTECH,SYR 918020,MO,54.0,F,"Fever, dizziness, weakness, fatigue, headache, site pain, swelling lymph nodes, severe joint pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/03/2021,4.0,WRK,"Vitamins, mobic, Trelogy MDI",None,Asthma,,Penicillin,"['Arthralgia', 'Asthenia', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Pyrexia']",1,MODERNA,IM 918021,FL,47.0,F,"BREATHING DIFFICULTY, STRIDOR, O2 SAT DROP, LIGHTHEADEDNESS, GENERALIZED ITCHING. AROUND 10 MIN POST INJECTION. BEENADRY 100MG TAKEN, 4 DOSES OF TWO PUFF OF PROAIR HFA TAKEN. BREATHING NORMALIZED. ITCHING REMAINED, LIGHTHEADED SUBSIDED. GENERALIZED TOTAL BODY ITCHING CONTINUED THROUGH THE 3RD TODAY, LESSENDED YESTERDAT THE 2ND. BREATHING DIFFICULTY SOB AND TIGHTNESS RESUMED TODAY 1/3/2021 FOR ABOUT 2 HOURS BENADRYL 150 MG TAKEN , PEPCID 40 MG TAKEN, CLARATIN TAKEN PROAIR PUFFS TAKEN X 5 . CHEST TIGHTNESS CONTINUES, ITCHING CONTINUES AND BENADRYL CONTUNES TO BE USED WITH PUFFS FOR RELIEF. NORMAL MEDS TAKEN AS WELL XYZAL AND SIGULAR",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,SEN,Norvasc claritin Pepcid Zyrtec Singulair Beandryl Hydrachlorathiazide,None,"HTN, Allergies",,"ACE Inhibitors, Pepper, Avocadoes, Honeydew, Tumeric, Curry.","['Chest discomfort', 'Dizziness', 'Dyspnoea', 'Oxygen saturation decreased', 'Pruritus', 'Stridor']",1,PFIZER\BIONTECH,IM 918022,NJ,35.0,M,"12 hours post vaccination, first symptom was nausea and fatigue. At this time, heart rate elevated to 122 bpm while at rest, and oxygen saturation decreased to 92% while supine with head of bed elevated to 30 degrees. The following morning, experienced general malaise, shortness of breath with stairs and household ambulation, and body aches/joint pain. Symptoms resolved Sunday evening, however experiencing minimal shortness of breath, in comparison to day 1.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,OTH,"Vit C, Zinc",None.,Fatty Liver.,,Levaquin,"['Arthralgia', 'Dyspnoea', 'Dyspnoea exertional', 'Fatigue', 'Heart rate increased', 'Malaise', 'Nausea', 'Oxygen saturation decreased', 'Pain']",1,MODERNA,IM 918023,CO,40.0,F,"Received shot 12/28/2020 Monday Monday evening started feeling normal side effects By Tuesday morning 12/29/2020 vomiting, severe arm pain, horrible migraine headache, horrible body aches, chills, exhaustion, and eyes burning. By Tuesday night very ill, vomiting uncontrollably, horrible headache, bad enough medication taken to sleep and stop vomiting (phenagren). By Wednesday skin hurt so bad couldn't touch or be touched....shower was miserable. Continued vomiting and lips started to swell. Started taking benedryl. Lips swollen. So tired and body aches horrible. Vomiting continued...no food eaten since Monday. Call urgent care about lips and symptoms, they said to take benedryl and continue to monitor if things worsen go to hospital. Vomiting continued into late Thursday night. Unable to eat normally now, stomach very very sensitive and nauseated. Extremely tired and headaches continue. Fearful to get booster. Been sick for 7 days and still not well.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,Topiramate 25mg Acetazolamide ER 500 mg Dexilant 65mg Aleve Hydroxozine 10mg Botox,"Residing symptoms of covid virus...lungs, coughing, Breathing issues due to Covid.",Chronic Migraines Pseudo Tumor Cerebri,,Penicillin Reglan Zofran Halodol Bee stings Peanuts,"['Chills', 'Eye irritation', 'Fatigue', 'Lip swelling', 'Migraine', 'Pain', 'Pain in extremity', 'Skin sensitisation', 'Vomiting']",1,MODERNA,IM 918024,OH,33.0,F,"On dec 31 woke up with red, itchy bumps on knuckles. By end of night noticed knees were itchy with bumps and husband reviewed other joints finding itchy bumps on elbows toes and more bumps around hands. Took pictures benadryl and went to sleep. Woke up Friday jan 1st noticed condition worsened as bumps were more red with prominent centers. Inside of fingers were painful to make fists. Went to urgent care prescribed pregnazone 20mg 2 times daily for 5 days, triamcinolone acetonide cream usp, 0.1% and instructed to get cetrizine hcl 10 mg. Took all and no relief by 5pm condition worsened and was still unbearbly itchy with sensitivity to warm water causing needlike pain. Jan 2nd woke again condition spread and affected areas enlarged. Went to hospital er. Was told body is fighting something it will run its course. Told to followup with dermatologist. Jan 3rd still taking prescription with little effect raised bumps flattened but spread further and bruised appearance in center. Bottom of feet swollen and painful. Hand swelling started",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PUB,Prenatal vit Vit D,None,,Sick after flu vaccine 2009,,"['Contusion', 'Hyperaesthesia', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Rash', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",1,MODERNA,SYR 918025,CT,65.0,F,"Started approx 80 minutes after injection with soft palate swelling and throat fullness, followed by change in voice, and chest tightness with paresthesias. Went directly to ED. Sats were good, no wheeze, throat swelling was noted. BP initially 150/93, peaked at 189/93,. Was 148/67 at discharge. Received oral Benadryl and Zyrtec, IV dexamethasone and Pepcid. ECG was done, no other labs. Observed for approx 90 minutes with improvement of all symptoms. Did need to take additional Benadryl dose approx 5 hours after first dose for return of mild throat fullness and rising BP. Both resolved within 30 minutes of dose. No further throat symptoms, BP fluctuations for over 24 hours now",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,None,None,None,,Macrolides cause severe diarrhea,"['Blood pressure increased', 'Chest discomfort', 'Dysphonia', 'Electrocardiogram', 'Mouth swelling', 'Palatal disorder', 'Paraesthesia', 'Pharyngeal swelling']",1,MODERNA,IM 918026,TX,51.0,M,"Dizziness, shortness of breath, swollen hands and fingers, shaky blurred vision. all occurred 2 hours after giving the shot. Patient was given benadryl and felt better in about 1 hour, he went home and the next day came back to work normal",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,SEN,none,none,none,,tylenol,"['Dizziness', 'Dyspnoea', 'Peripheral swelling', 'Tremor', 'Vision blurred']",1,PFIZER\BIONTECH,IM 918027,RI,36.0,M,fever to 106 Degree Fahrenheit by digital thermometer,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/03/2021,1.0,PUB,none,none,none,,none,['Pyrexia'],1,MODERNA,IM 918028,IN,32.0,F,Pain at injection site Chills Low grade fever,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,PVT,Tylenol,Eosinophilia esphagitis,Eosinophilia esphagitis Obesity,,Tramadol Reglan,"['Chills', 'Injection site pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 918029,NY,46.0,F,"1.At time of vaccination-Felt flush, dizzy, mild breathing difficulty- resolved with 1 OTC dose of Benadryl 2. 2 days after the vaccination I developed a high fever of 103, chills, headache, runny nose- lasted for 5 days with fever gradually lowering until normal 3. January 1 I developed a rash on my arm around the site of the injection- raised rash, itchy, hot to the touch. Rash began growing in size, with increased symptoms of shoulder pain/aching, headache, low grade fever-100. I took 3 Benadryl and put hydrocortizone cream on it,. By this morning it decreased in puffiness/swelling and redness, but has spread to cover my entire upper left arm and is still like that.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,"Estradiol, Gabapentin, Atenalol, Bupropion, Methacarbomol, Tramdol, Cetrizine,",,Monoclonal Gammopathy with Peripheral Neuropathy; SVT's,,"TB-Tine test, nuts","['Arthralgia', 'Chills', 'Dizziness', 'Dyspnoea', 'Erythema', 'Headache', 'Hot flush', 'Immediate post-injection reaction', 'Injection site rash', 'Peripheral swelling', 'Pruritus', 'Pyrexia', 'Rash', 'Rash papular', 'Rhinorrhoea', 'Skin swelling', 'Skin warm']",1,MODERNA,IM 918030,CA,41.0,F,Injection site moderate to severe muscle pain,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,PVT,,,Anemia,,None,"['Injection site pain', 'Myalgia']",UNK,MODERNA, 918031,,,U,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,,,,UNK,,,,,,['Unevaluable event'],UNK,MODERNA, 918032,WA,51.0,F,After I took the vaccine about six hours later I started to have chills and a fever.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,"Metformin, Januvia , Losartan potassium , Lantus ,and NovoLog",No,diabetes and hypertension,flu shot,Not what i know of,"['Chills', 'Pyrexia']",,MODERNA,SYR 918034,MI,35.0,F,"I was 28 weeks and 5 days pregnant when I received the first dose of the COVID19 vaccine. Two days later (12/25/2020 in the afternoon), I noticed decreased motion of the baby. The baby was found to not have a heartbeat in the early am on 12/26/2020 and I delivered a 2lb 7oz nonviable female fetus at 29 weeks gestation. I was 35 years old at the time of the fetal demise and the only pregnancy history for this pregnancy included a velamentous cord insertion that was being closely monitored by a high risk OB. My estimated due was March 12, 2021.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/23/2020,12/25/2020,2.0,PHM,"Advair, Pulmocort, levothyroxine, pepcid, prenatal vitamins, singulair, aspirin",None,Asthma,,None,"['Exposure during pregnancy', 'Foetal death', 'Foetal heart rate abnormal', 'Foetal hypokinesia', 'Premature delivery', 'Stillbirth', 'Ultrasound Doppler', 'Ultrasound foetal']",1,PFIZER\BIONTECH,IM 918035,MA,46.0,F,"4 days after vaccine I got a blotchy rash on lower back, itchy hives. On day 5 I had blotchy itchy hives on neck, part of face, upper and lower back, a spot on buttock cheek. Also have some itchy spots in under arm area. I took a Loratidine 10mg 24 hour tab to help with itchy hives.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,WRK,"Levothyroxine, Ibuprofen, Acyclovir",none,hypothyroidism: under control with medication.,,"Diphenhydramine, Clindamycin, Vicodin, food dyes","['Pruritus', 'Rash', 'Rash macular', 'Urticaria']",1,PFIZER\BIONTECH,IM 918036,MO,38.0,F,"Lymph node swelling on left side of neck, about a ping pong ball sized with a smaller node next to it. This has continued up to this day (day 12) On day 10, large red circle around the vaccine area, about 2.5 inches in diameter and has continued to this day",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/27/2020,4.0,UNK,,,,,Sulfa,"['Injection site erythema', 'Lymphadenopathy']",1,MODERNA,SYR 918037,NH,36.0,F,"Injection Site Pain, Headache, and chills. Using Antipyretics. Left work. Symptoms subsiding on day 2 of injection",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,,,Asthma,,,"['Chills', 'Headache', 'Injection site pain']",1,MODERNA,IM 918038,PA,27.0,F,Cutaneous wheal and erythemtous streaking around injection site (deltoid) and down adjacent bicep,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/03/2021,11.0,PVT,Levothyroxine Prenatal vitamin,None,Hypothyroidism,,"Mangp, cashew, pistachio","['Injection site erythema', 'Injection site streaking', 'Injection site urticaria']",1,MODERNA,IM 918039,CA,51.0,M,"11 minutes after vaccine administration I began experiencing prickling sensation of mouth lips followed by prickling sensation of my tongue, increased heart rate and for a few seconds felt my throat tightening. Symptoms lasted a few minutes. By the time I was evaluated at the emergency department a few minutes later I was feeling much better. I did not need to take any medications. 7 hours later I began experiencing itching all over my body however, I never developed a rash. My heart rate slightly increased. Simply did not feel well. Symptoms lasted a few minutes and again resolved without having to take any medications.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,None,,None,,Salmon Fish,"['Electrocardiogram normal', 'Heart rate increased', 'Paraesthesia oral', 'Pharyngeal paraesthesia', 'Pruritus', 'Throat tightness']",UNK,PFIZER\BIONTECH, 918040,IA,32.0,F,"Wide spread itching starting around the site of injection less than 24 hours after injection and has continued. Itching is present on thorax, upper and lower extremities. Negative for visible rash. Erythema and palpable nodule only present around site of injection on left deltoid. Accompanied by tenderness of palpable lump from injection site. Only unexpected outcome was wide spread pruritis",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/01/2021,1.0,PVT,"NuvaRing, Adderall XR, Wellbutrin",None,Ehlers Danlos ADHD,,No known allergies,"['Injection site erythema', 'Injection site mass', 'Injection site nodule', 'Injection site pain', 'Injection site pruritus', 'Pruritus']",1,MODERNA,IM 918041,CO,42.0,F,"R axilla lymph node selling and R axilla pain started on Saturday 1/2/2021. R deltoid itching, and redness on 1/3/2021. Symptoms are ongoing and I will monitor. Will follow up with office visit if symptoms do not resolve.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,01/02/2021,6.0,PUB,"Vitamin D 5,000 iu every other day, melatonin 10mg prn",none,none,,NKDA,"['Axillary pain', 'Erythema', 'Lymphadenopathy', 'Pruritus']",1,MODERNA,IM 918042,CA,34.0,F,"Insomnia followed by severe anxiety and depression similar to symptoms she had when she had postpartum anxiety 2 1/2 years ago. Symptom onset was sudden and started the day after vaccination. She reports feeling ""happy and normal"" prior to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,Fish oil multivitamin,none,none,,Benzoin causes severe contact dermatitis,"['Anxiety', 'Blood thyroid stimulating hormone', 'Depression', 'Full blood count', 'Hepatitis C test negative', 'Insomnia', 'Metabolic function test']",1,PFIZER\BIONTECH, 918043,OH,59.0,M,"Fever Chills, diarrhea lasted about 48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,Lisinopril/HCTZ,Had covid19 two weeks previous was instructed by the two health department people that dropped off the vaccine it is recommended even after two weeks.,none,,none,"['Chills', 'Diarrhoea', 'Pyrexia']",2,MODERNA,IM 918044,,41.0,F,"Injection Site pain, Tiredness, And Headache using Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Fatigue', 'Headache', 'Injection site pain']",1,PFIZER\BIONTECH,IM 918045,,36.0,F,"First day Tiredness, Muscle pain, Injection site swelling (quarter size)and itchy. using ibprophen 600mg.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,UNK,,,,,,"['Fatigue', 'Injection site pruritus', 'Injection site swelling', 'Myalgia']",1,MODERNA,IM 918046,,45.0,F,"Dizziness and Weakness, Headache, Aches, Cold feeling, Nausea, generally feeling unwell.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,UNK,,,,,,"['Asthenia', 'Dizziness', 'Feeling cold', 'Headache', 'Malaise', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,IM 918047,,28.0,F,"Dizzyness at time of injection. Injection site pain, tiredness, Headache, feeling unwell. using ibprophen. Headache relieved after 1 day post injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/23/2020,0.0,PVT,,,,,,"['Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise']",1,MODERNA,IM 918048,NJ,44.0,F,"On January 2, 2021, a full seven (7) days after the initial injection, my arm became swollen at the injection site (left deltoid), there was redness, and the skin was warm to the touch. Concerned about a possible infection, I contacted the on-call physician for my pcp's office. I spoke with a Dr. and she stated that this could be an early infection, although it would be unusual for this to happen a full 7 days after the injection. She told me to wait until the next day and if there was no improvement I would be started on an antibiotic. The next day there was no improvement, although it wasn't worse it just stayed the same: redness, swelling, skin very warm to the touch. I was started on Keflex 500mg, 1 tablet 3 times per day x 10 days. I have only had 1 dose of the antibiotic but I am reporting this now. I anticipate the Keflex will resolve the infection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/02/2021,7.0,PVT,"Alive Multivitamin, Phentermine 37.5mg, Omeprazole 40mg, Lisinopril 5mg",None,"Hypertension, GERD",,"Doxycycline, Tetracycline, CT Contrast Dye","['Injection site erythema', 'Injection site infection', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 918049,,30.0,F,"For her hours after vaccine administration, experienced 10 to 15 minutes of left lower quadrant visual field defect. Was not associated with headache or other neurologic (sensory or motor) deficits. Patient with history of headaches and remote history of migraines but never migraine with aura. No personal or family history of cardiovascular disease or stroke. Visual field defect resolved completely and has not been experienced sense.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,UNK,NOne,Possibly a cold in the week prior,Intermittent mild asthma,,"Mild: Shellfish, Grass pollen",['Visual impairment'],1,PFIZER\BIONTECH,IM 918050,CA,24.0,F,"12/31 (10:45am): brain fog, dizziness, shortness of breath. (11:30am) previous + difficulty swallowing, generalized muscular weakness. (1400/2:00pm) previous + inability to swallow thin liquids/dry solid foods, palpitations, HR of 106bpm, myalgia and joint pain in areas previously affected by injuries/tendonitis (R/L wrist, R elbow, R shoulder, C spine, lumbar spine, R hip joint, R sartorious muscle, R medial knee, R achilles/ankle) - went to emergency room for allergic reaction evaluation; was experiencing similar reaction to food allergies. (~1600/4:00pm) aspirated thin fluids (water/saliva) and tolerated solid foods, dizziness, myalgia, fatigue. 12/31-1/1: fell asleep at 7pm 12/31, did not wake up until 8:30pm 1/1. dizziness, nausea, weakness, vertigo, difficulty swallowing without pain, lack of appetite/thirst. 1/1-1/2: fell asleep at 9pm 1/1 and woke up at 12pm 1/2. dizziness, sensitivity to cold, nausea, generalized weakness, loss of appetite. 1/3: generalized vertigo throughout body, all day. greater intensity upon standing from sitting position or walking. loss of coordination, brain fog, speech pattern. spasms in muscles, jaw, and eyes. eyesight blurry and out of focus.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"112mcg levothyroxine, 10mg lexapro, 10mg hydroxyzine, 20mg omeprazole, 10mg montelukast, 10mg adderall twice/day.",,"Hashimoto's hypothyroidism, ADHD, anxiety, Raynaud's syndrome",,"latex, avocado, banana, grapefruit","['Arthralgia', 'Asthenia', 'Blepharospasm', 'Coordination abnormal', 'Decreased appetite', 'Dizziness', 'Dysphagia', 'Dyspnoea', 'Feeling abnormal', 'Feeling cold', 'Muscle spasms', 'Muscular weakness', 'Myalgia', 'Nausea', 'Palpitations', 'Speech disorder', 'Trismus', 'Vertigo', 'Vertigo positional', 'Vision blurred']",1,MODERNA,IM 918051,NJ,33.0,F,"At around 40 hours post vaccination, developed severe abdominal pain and went to an emergency room for evaluation on 1/1/21. Abdominal pain was eventually diagnosed as appendicitis requiring appendectomy on 1/2/21. Emergency room visit and hospital discharged patient early on 1/2/21. It was then determined that the on-call team covering mis-read the CT scan and acute appendicitis was found. Patient then went to Medical Center on 1/2/21 for appendectomy and was discharged later that night following operation.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,prenatal vitamin,,,,,"['Abdominal pain', 'Appendicectomy', 'Appendicitis', 'Computerised tomogram abdomen abnormal', 'Laboratory test', 'Liver function test', 'Ultrasound abdomen', 'Ultrasound pelvis']",2,MODERNA,IM 918053,,34.0,F,"Fast Heart rate, injection site pain golf ball size lump red hot, 48 hours later red sore spot, muscle pain at site feels like a punch, fever 100.9 for 4 hours after injection, mild scratchy throat. 12/24/20 symptoms subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,UNK,,,,,,"['Heart rate increased', 'Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site warmth', 'Oropharyngeal discomfort', 'Pyrexia']",1,MODERNA,IM 918054,NY,57.0,F,I experienced a rapid heart beat shortly ( about 3 min) after receiving the vaccine. It lasted about two minutes and resolved by itself. I did not alert the staff in the observation room because it came suddenly and it didn't last a long time.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,otc Naproxen-1 tab,none,none,,sulfa,['Heart rate increased'],1,MODERNA,IM 918056,MI,27.0,F,"It started on 12/30/20 around 10 pm with just a headache, then it progressed to hot flashes and nausea. I ended up throwing up around 4 am on Thursday 12/31/20 at work. Then over the weekend I felt very lethargic, had body aches, and the hot flashes continued. My left arm hurt as expected, but the soreness went up into the left side of my neck as well. Today (1/3/21) is the first day since I got the vaccine where I no longer have a headache and feel basically back to baseline.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,None,None,None,"Occasionally with the flu vaccine (Nausea, headache, body aches)",Bactrim- rash at age 2-3,"['Headache', 'Hot flush', 'Lethargy', 'Nausea', 'Neck pain', 'Pain', 'Pain in extremity', 'Vomiting']",1,MODERNA,IM 918057,NY,64.0,M,"Developed fever, chills, malaise within 24 hrs of inoculation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,"Metoprolol, Hydrochlorothizide, Rosuvaststin, Famotidine, VISIBIOME DS.",,Hypertension; Obesity,,NKA,"['Chills', 'Malaise', 'Pyrexia']",1,PFIZER\BIONTECH,IM 918058,TX,56.0,M,"""... I felt a prickle across both arms. It was scattered like having metal shavings in the sleeves, and almost instant and want away. Shortly thereafter, i tased metallic on the left side of my tongue, followed by a tingle, as I was coming out a novocaine shot."" Which all resolved. The next day he has some lightheadedness and reports forgetting things.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/01/2021,1.0,PVT,not to my knowledge,Not to my knowledge,I10 HTN (hypertension) E78.5 Dyslipidemia R73.01 Impaired fasting glucose J45.909 Allergy-induced asthma J30.1 Allergic rhinitis due to pollen I44.7 Left bundle branch block K58.9 Irritable bowel syndrome without diarrhea I47.1 SVT (supraventricular tachycardia) K21.9 GERD (gastroesophageal reflux disease) Z86.79 History of paroxysmal supraventricular tachycardia E55.9 Vitamin D deficiency,,"Alcoholic drinks, Amoxicillin, Prilosec, Prevacid","['Dizziness', 'Dysgeusia', 'Memory impairment', 'Paraesthesia', 'Paraesthesia oral']",UNK,MODERNA, 918059,OR,37.0,F,"Racing heart, pain in arm, and dizziness 10 minutes after shot that lasted only a few minutes. Nausea, dry mouth with metallic taste, chills, head pressure and a rush sensation through the body for 2 hours after injection. Nausea comes in waves still 3 1/2 hours after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,Montelukast and Omepazole,None,Exercise induced asthma,,None,"['Chills', 'Dizziness', 'Dry mouth', 'Dysgeusia', 'Feeling abnormal', 'Head discomfort', 'Nausea', 'Pain in extremity', 'Palpitations']",1,MODERNA,SYR 918710,OH,62.0,F,Started in arms - heaviness in muscle's - went to legs - (not joints). heaviness in center of chest & tightness in neck.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,Breast Cancer.,,NKA,"['Chest discomfort', 'Limb discomfort', 'Muscle tightness']",1,MODERNA,IM 918061,CA,32.0,F,"Headache, muscle pain on the site of injection, chills, nausea, fever. Started time 01.03.2021 8:15pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,WRK,None,None,None,Flu,Not that I know.,"['Chills', 'Headache', 'Injection site pain', 'Nausea', 'Pyrexia']",1,MODERNA,IM 918062,TX,33.0,F,"15 min after the vaccine I was flushed and felt hot , ears felt hot as well. I had a macular rash on chest and arms. My throat felt itchy and they immediately gave me benedryl. I was tahycardic as well. When I got home from the ER that night I had to take more benedryl and then the next morning I was still itchy and my voice was hoarse so I took more xyzal and famotidine. The rash subsided and I continued taking xyzal twice a day , benedryl and famotidine for a week. After my vaccine the itching did not subside for about 48 hours and it was very difficult to control. I had to take max doses of antihistamines to control the hoarseness In my voice and itching",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/18/2020,0.0,WRK,"Xyzal 5mg QD, Brillinta 90mg BID, ASA 81mg qD",Right MCA stroke as a result of a right coratid dissection on 11/8. I have idiopathic urticaria which are controlled with daily antihistamines.,Chronic urticaria,,NKDA,"['Dysphonia', 'Feeling hot', 'Flushing', 'Pruritus', 'Rash macular', 'Tachycardia', 'Throat irritation']",UNK,PFIZER\BIONTECH, 918063,OK,47.0,M,"High fever (104.2 degrees) at present, fatigue, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Pyrexia']",1,MODERNA,SYR 918064,TX,67.0,F,"Blood pressure and pulse rate increased to 164/64, 85",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,Enbrel Benicar Metoprolol Atorvastatin calcum Desvenlafaxine Omeprazole Jardiance Azelasrine nasal spray Fluticasone Vitamin D Vitamin c Zinc,,Blood pressure Diabetic- treated with medication Psoriasis,,Prozac - I get all of the side effects Lexapro Seasonal allergies Corn - if I eat to much I start coughing. If it get really bad I have to take a nebulizer treatment,"['Blood pressure increased', 'Heart rate increased']",UNK,PFIZER\BIONTECH, 918065,CA,64.0,M,1/1/2020: Residents was found unresponsive. Pronounced deceased at 6:02pm,Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,OTH,- Invega Trenza 546mg Q3months - Lithium 300mg BID - Oxybutynin 5mg QID - lipitor 20mg QHS - cogentin 2mg BID - Norvasc 5mg QD - Dyazide Capsule 37.5-25 MG (Triamterene-HCTZ) QD,- covid-19,"- SCHIZOPHRENIA, UNSPECIFIED - ANEMIA, UNSPECIFIED - OVERWEIGHT - OVERACTIVE BLADDER - ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS - HYPOTHYROIDISM DUE TO MEDICAMENTS AND OTHER EXOGENOUS SUBSTANCES - NICOTINE DEPENDENCE, UNSPECIFIED, UNCOMPLICATED - CHRONIC VIRAL HEPATITIS C - UNSPECIFIED AGE-RELATED CATARACT - ESSENTIAL (PRIMARY) HYPERTENSION - CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED - UNSPECIFIED CONVULSIONS - INHALANT ABUSE, UNCOMPLICATED - OTHER SEIZURES",,- Clozaril - Tegretol,"['Death', 'Unresponsive to stimuli']",1,MODERNA,IM 918066,MO,40.0,F,"Approximately 11:00pm on 12/29/20: Hives/itching on bilateral hands/wrists/forearms/lower legs/ankes, red face/swelling on face, rapid pulse, headache, nausea, extreme fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Zyrtec, 10mg daily Adipex, 37.5 daily Zovirax, 100mg daily Omeprazole, 20mg daily Lysine, 1000mg daily Gelatin, 500mg daily One-A-Day Women's Multivitamin, daily",,,,,"['Erythema', 'Fatigue', 'Headache', 'Heart rate increased', 'Nausea', 'Pruritus', 'Swelling face', 'Urticaria']",1,MODERNA,IM 918067,CA,35.0,F,"At about almost 4 hrs after receiving the injection I started to experience a tingly feeling to my lips, some lip swelling and tightness in my throat. I had my epi pen on hand incase I needed it but I ended up taking 25mg of Benadryl, then 50 mg of Benadryl 5 hrs later. The following morning my lips where feeling tingly again so I took 25mg of Benadryl again and continued for the next 48 hrs at the advice of my doctor.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Nexium, Xyzal",,Chronic allergic rhinitis,,"Tamiflu Severe allergies to cats, dogs, mold, weeds, trees, grass, pollen","['Lip swelling', 'Paraesthesia oral', 'Throat tightness']",1,PFIZER\BIONTECH,IM 918068,TN,61.0,F,"About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, feeling that I would pass out, lightheafdedness, increased heart rate and blood pressure, mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness, very slight throat soft tissue sensation",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,WRK,"Lexapro 10mg, Omeprazole 40mg, Multivitamin, ibuprophen 400mg",none,None. Had breast cancer in 2003 and a recurrence in 2007.,,"sulfa, taxol","['Balance disorder', 'Blood pressure increased', 'Burning sensation', 'Cardiac monitoring', 'Chest discomfort', 'Disturbance in attention', 'Dizziness', 'Heart rate increased', 'Peripheral coldness', 'Presyncope', 'Speech disorder', 'Thinking abnormal', 'Throat irritation']",1,PFIZER\BIONTECH,SYR 918069,CA,39.0,F,"Fatigue, sore muscle",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,SEN,None,None,None,,None,"['Fatigue', 'Myalgia']",UNK,MODERNA, 918071,PA,22.0,F,"extreme body aches, fever of 101 degrees F, pain at injection site, severe headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,PVT,"valacyclovir, mirena iud, adderall, wellbutrin, cranberry pills, iodine supplement, multi vitamin",lyme disease,none,,none known,"['Headache', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 918072,IL,50.0,F,Swollen painful lymph node left clavicle,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/24/2020,7.0,PVT,Aubagio 14pm op qd Protonix 40mg op bid Vit C 500mg op bid Biotin op qd Iron po qd,None,MS,,NKA,"['Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 918073,WA,50.0,F,"Redness and swelling an inch away from the injection site, hives on face",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PUB,"Adderall, tramadol, carbidopa-levodopa, losartan, Combivent, Albuterol",None,"COPD, Fibromyalgia, Osteoarthritis, Scoliosis",,"Vicoden , ivory soap","['Injection site erythema', 'Injection site swelling', 'Urticaria']",1,MODERNA, 918074,LA,47.0,F,"Migraine with nausea and dizziness preceded by visual aura, severe left arm pain (could not raise arm without significant pain), left wrist pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/14/2020,12/14/2020,0.0,PVT,"Daily vitamin, daily calcium/vitamin D supplement, Aimovig, Maxalt, 2 mg Valium (muscle relaxant low dose)",None,Migraines with aura,Egg shaped erythema around injection site (diameter 5-6 inches) with moderate arm soreness and pain,None,"['Arthralgia', 'Aura', 'Dizziness', 'Injected limb mobility decreased', 'Migraine', 'Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 918075,FL,67.0,F,"about 1 hour and 15 minutes post injection (I waited in area as recommended for thirty minutes because of hx), I had the sudden onset of itchy runny nose and chest tightness and wheezing of significant intensity that I needed to use inhaler then and again later in the day. Noteworthy, I had as a precaution taken prednisone 20mg p.o about 2 hours before the injection. I had to take more later that afternoon because of symptoms. I then seem better but several times since the vaccine I have needed to uses the inhaler and take prednisone more than I have except after an infection about 6 years ago that precipitated similar symptoms to now. Today I had a flare significant enough that except for covid I might have gone to the ER or urgent care.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,OTH,Prednisone Alupent inhaler,"Hx mild asthma, not on tx at the time of reactions but always keep medicines handy, last attack requiring ongoing steroids about 6 years prior, last SOB of that intensity about 6 years prior","allergic asthma, episodic, usually in association of URI or exposure to cats, this attack worse in about 6 years .",,"Foods: Shell fish, Peaches, Strawberries Medications, Pcn, Sulfa, ?Clindamycin airborne: multiple trees, wees, grasses on skin testing many years ago, significant allergy to cats - allergic rhinitis, wheezing, itchy eyes etc.","['Chest discomfort', 'Nasal pruritus', 'Rhinorrhoea', 'Wheezing']",1,PFIZER\BIONTECH,IM 918076,CA,54.0,M,Resident noted with right sided facial swelling and lip droop. diagnosed as bells Palsy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/03/2021,4.0,OTH,- lipitor - lithium - clozapine - ativan,- COVID-19,"SCHIZOPHRENIA, UNSPECIFIED GAF:UNKNOWN OVERWEIGHT DISEASE OF INTESTINE, UNSPECIFIED NICOTINE DEPENDENCE, UNSPECIFIED, UNCOMPLICATED DISORDER OF TEETH AND SUPPORTING STRUCTURES, UNSPECIFIED HYPOTHYROIDISM, UNSPECIFIED HYPERLIPIDEMIA, UNSPECIFIED HEMANGIOMA OF INTRA-ABDOMINAL STRUCTURES LIVER DISEASE, UNSPECIFIED 6/20/2017 ANEMIA, UNSPECIFIED",,nka,"['Facial paralysis', 'Swelling face']",1,MODERNA,IM 918077,MO,34.0,F,"Slight headache a few ours later after vaccination. The next morning I had headache, some joint/muscle pain, right arm pain and a Fever. That evening/night Fever and chills. The following morning still had a fever and chills. All symptoms were gone later that evening (within 48 hours of initial vaccination time)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,None,I have Hereditary Spherocytosis and have had a Splenectomy.,,None,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 918078,KY,44.0,M,"4 hours after vaccine, sore arm, fatigue, headache, blurred vision 12 hours after vaccine, full body tremors, fever of 102, extreme muscle weakness, fatigue, deep chest cough, shortness of breath. fatigue, weakness and cough continued for three days after vaccine before subsiding",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,,,,,,"['Cough', 'Dyspnoea', 'Fatigue', 'Headache', 'Muscular weakness', 'Pain in extremity', 'Pyrexia', 'Tremor', 'Vision blurred']",1,MODERNA,SYR 918079,OH,58.0,F,"on the following day after the vaccination, I developed chills, awful headache, body aches, extreme fatigue, malaise, no fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,"lisinopril, singulair, brio inhaler, simvastatin, Effexor, welbutrin, abilify, vitamin d, vitamin c, multi vitamin, allegra",none,"asthma, type 2 DM, HTN, obesity, sleep apnea, depression",,"codeine sensitive, allergic to marcane in epidural anesthessia","['Chills', 'Fatigue', 'Headache', 'Malaise', 'Pain']",1,MODERNA,IM 918080,AL,52.0,F,"Fatigue, headache, body aches, chills, localized rash",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/01/2021,4.0,PVT,"Effexor xr 75 mg, zinc 30 mg, melatonin 5mg, quecertin 50mg, vitamin c 200, vit d 2000 iu",None,None,,Goose down,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Rash']",1,MODERNA,IM 918081,NY,26.0,M,"I received the shot around 0730 on 12/30/2020. Went home and got ready for work. Around 12am 12/31/2020 my arm started to radiate at the injection site and was very tense. I placed a heat pack on the right harm but the pain did not dissipate. My arm continued to be in pain for the rest of the night. Around 0240 I ate dinner, had water and still had some arm pain. Around 0345 my arm started to flare up and sent pain sensations throughout my body. My right arm was increasingly discomforting, I could barely move it. The sensations spread to my legs, numbing them and my throat had felt as if it were closing up. I got up to get the attention of the nurse and was able to flag her down. She said I was pale as a ghost. My vision was very blurry, I could not hear anything because my ears had filled up and everything was muffled. My head had begun to ring and I was on the brink of fainting when a chair was given to me. My eyes had become extremely sensitive to the light, I was given water and spoken to about what had happened leading up to the event. I was greeted by the paramedics who drew my blood, placed an IV and transferred me to the Acute Care portion of the Emergency Department. My vitals were 76/49, 80/50, 90/56, 100/60 before being brought to the ER. On 1/1/2021 My thighs have been sore/tense, my knees and ankles have been stiff and just feeling sickly. On 1/2/2021 much of the same symptoms are present. The soreness in the muscles isn't as prevalent, however joints still are stiff On 1/3/2021, congestion and runny nose are still present, stiffness in ankles and now shins are prevalent.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,SCH,Nutrilite Men's Pack ( Daily Vitamin),"Cough, Congestion, Runny nose",Raynaud's,,None,"['Chest X-ray', 'Ear discomfort', 'Haematology test normal', 'Hypoaesthesia', 'Injected limb mobility decreased', 'Injection site pain', 'Injection site reaction', 'Joint stiffness', 'Laboratory test normal', 'Malaise', 'Musculoskeletal stiffness', 'Pain', 'Pain in extremity', 'Pallor', 'Photophobia', 'Presyncope', 'Throat tightness', 'Tinnitus', 'Vision blurred']",1,MODERNA,SYR 918082,TX,50.0,M,"On 12-22-2020, approx. 2 days after vaccine, I noticed several non-tender lumps under my chin/adjacent to left jaw line ~ small gum drop size lumps seemed to congeal together over next 9 days into a single half-dollar dollar sized lump - not completely round.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/22/2020,2.0,PVT,"1. Vyvanse, 70mg caplet daily (1x per day). 2. Metformin, 500mg tablet 2x per day.",None,"PMH includes chronic rectal bleeding (hemorrhoid surgery 1990 and 2013), chronic low WBC# (avg. 3.4) and low Neut# (avg. 1.4) since 1990 (2018 Bone Marrow Biopsy was inconclusive / doctor said it was possibly due to my ethnic heritage: African-American variant),eczema, exostosis of jaw, and varicose veins (surgical varicose vein removal from right leg in 2004).",,No,"['Blood test', 'Computerised tomogram', 'Mass']",1,PFIZER\BIONTECH,SYR 918083,OH,56.0,F,Headache Chills Temp (101.6) Body aches Skin hurts to touch Soreness in arm (injection site),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,SEN,Synthroid 100mg,,Osteoarthritis,,Percocet,"['Chills', 'Headache', 'Injection site pain', 'Pain', 'Pain of skin', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 918084,CA,61.0,M,"Hospitalized with COVID-related pneumonia on 03 Jan 2021. Close contact exposure on 25 Dec, with positive COVID PCR test on 29 Dec... managed as outpatient until respiratory sxms prompted hospitalization on 03 Jan. Care team anticipates at least 4 inpatient days... but patient remains hospitalized at date of this report.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,12/21/2020,01/03/2021,13.0,MIL,"Micardis 40mg daily, Norvasc 10mg daily, Zocor 40 mg daily",None reported,HTN Hyperlipidemia,,NKDA,"['COVID-19 pneumonia', 'Chest X-ray abnormal', 'Exposure to SARS-CoV-2', 'Respiratory symptom', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 918086,,31.0,M,Patient developed SVT 15 minutes after receiving vaccine. Admitted to ICU. ER presentation: BP: 160/109 heart rate 132. No e/o anaphylaxis or allergic reaction.,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/04/2021,01/04/2021,0.0,MIL,None,None,None,"2016, Age 27, Flu Vac QS 2016",Flu Vaccine,"['Electrocardiogram abnormal', 'Intensive care', 'Sinus tachycardia', 'Supraventricular tachycardia']",1,MODERNA,IM 918087,CO,38.0,F,"Sore throat, cold symptoms 3 days after, bone pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,,,,,Sulfa,"['Bone pain', 'Nasopharyngitis', 'Oropharyngeal pain']",UNK,MODERNA, 918088,MI,62.0,F,The vaccine was given in the deltoid tendon/shoulder bursa area NOT in the deltoid muscle.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,"Estrace 0.5mg, Vitainn D 2000iu, Mucinex 600mg qd",none,none,Flu vaccine causing shoulder pain for months following being given too high. Occurred about 6 years ago.,none,['Product administered at inappropriate site'],1,PFIZER\BIONTECH,IM 918089,NJ,65.0,F,"Jan 3, 2021 mild pain at injection site, diarrhea all day, chills in morning , no fever, temp 97.6 Jan 4, 2021 significant arm pain at injection site (awakened by it at 3 am) with chills, temp 99.6. Took One tablet ALEVE followed by temp 98.6",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/03/2021,1.0,PVT,Lisinopril 5mg PO once daily Macrodantin 50 mg PO once daily,NONE,NONE,,"Sulfa drugs, Thimerosal","['Body temperature increased', 'Chills', 'Diarrhoea', 'Injection site pain']",1,PFIZER\BIONTECH,SYR 918090,TX,39.0,F,"Rash on sides started Thursday. Woke up Friday and rash is all over body itching red and hurts. Taken Benadryl, pepsid and hydrocortisone cream. Called tele doc they gave prednisone nothing is working getting worse",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,None,None,None,,Mango,"['Rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 918092,VA,49.0,F,"Patient is a 49 y.o. female with a PMHx of AAT deficiency, HPV infection, DVT, Vitamin D Deficiency, Hypercholesterolemia and Anxiety with complaints of acute left arm numbness that radiates into her left digits and chest tightness that began 12-13 min after receipt of the COVID-19 vaccine. She noted numbness radiation into the left side of the neck and the bilateral ears. She voices she has also developed chest tightness and wheezing. Evaluated in the emergency department treated with diphenhydramine 25mg, epinephrine 0.3mg and dexamethasone 10mg",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,,,"AAT deficiency, HPV infection, DVT, Vitamin D Deficiency, Hypercholesterolemia and Anxiety",,ammonia,"['Chest X-ray', 'Chest discomfort', 'Electrocardiogram', 'Hypoaesthesia', 'Metabolic function test', 'Wheezing']",1,PFIZER\BIONTECH,IM 918093,WI,65.0,F,sore arm at injection site for about 1 day,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,UNK,,,,,,['Injection site pain'],UNK,PFIZER\BIONTECH, 918094,NM,54.0,F,"Pain and swelling in arm where injection was received. Lymph nodes in axilla and in neck were also swollen and painful. Eyes were described as ""glassy"", Two medications prescribed Lidocaine Patch and Naproxen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,SEN,Amlopidine Metformin,None reported,None,,NKDA,"['Glassy eyes', 'Injection site pain', 'Injection site swelling', 'Laboratory test', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 918109,LA,4.0,M,"Allergy to vaccines; Had ICP; platelets dropped to 2; Almost died from MMR vaccine; This spontaneous report has been received from a registered nurse concerning a 4-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) as prophylaxis (strength, dose, vaccination schedule, route and anatomical site of administration, lot number, and expiration date were not reported). On an unknown date, the patient almost died from measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccine (vaccination complication). In addition, the patient experienced allergy to vaccines, for which he was two weeks hospitalized. On an unknown date, the patient had intracranial pressure increased (ICP) and his platelets dropped to 2 (units not provided) (platelet count decreased). The patient was advised by the pediatrician to never take another vaccine, and at the reporting time, the patient had 24-year-old and still had a significant allergy to vaccines (not recovered). The outcome of vaccination complication, platelet count decreased, and intracranial pressure increased were not reported. The reporter considered allergy to vaccine and vaccination complication to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown). The causality assessment between the suspect therapy administration and the events of platelet count decreased, and intracranial pressure increased was not reported. The event vaccination complication was considered to be a life-threatening event by the reporter. Furthermore, upon internal review the event of intracranial pressure increased was considerer to be medically significant.",Not Reported,,Yes,Yes,,Not Reported,N,,,,UNK,,,,,,"['Allergy to vaccine', 'Intracranial pressure increased', 'Platelet count decreased']",UNK,MERCK & CO. INC., 918127,CO,,M,"severe Shingrix vaccine reaction / hospitalized for almost three weeks; This case was reported by a consumer via call center representative and described the occurrence of hospitalization in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown. It was unknown if the reporter considered the hospitalization to be related to Shingrix. Additional information was provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The reporter stated that she had a complex issue, but it was a severe Shingrix vaccine reaction, patient was hospitalized for almost three weeks. The reporter was wondering what commonalities there might be with the new COVID vaccines. She was guessing other people have this big problem, so that to her it was something that need to figure out, so she don't have to have her doctor track this down. The reporter consented to follow up.; Reporter's Comments: realize we have a complex issue, but it was a severe Shingrix vaccine reaction, my husband was hospitalized for almost three weeks, (inaudible) I was wondering what commonalities there may be with the new COVID vaccines. I'm guessing other people have this big problem, so that to me is something you guys need to figure out, so I don't have to have my doctor track this down.",Not Reported,,Not Reported,Yes,21.0,Not Reported,U,,,,UNK,,,,,,['Vaccination complication'],UNK,GLAXOSMITHKLINE BIOLOGICALS, 918128,,,F,"Seizures; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a female patient who received DTPa (DTaP vaccine) for prophylaxis. On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. The reporter considered the seizure to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported Reporter daughter reacted to DTaP, when she was a baby. Seizures abd the like. However, when reporters daughter was older, reporter went back and got her vaccinated. She didn't react that time.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Seizure'],UNK,UNKNOWN MANUFACTURER, 918131,AL,,F,"7 th cranial nerve affecting the right side of her pallet; Herpes zoster on lip; has a pustule on lip; This case was reported by a nurse via call center representative and described the occurrence of herpes zoster infection neurological in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (Shingles thrice). Previously administered products included Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, less than 2 months after receiving Shingrix, the patient experienced herpes zoster infection neurological (serious criteria GSK medically significant), herpes zoster and lip pustule. On an unknown date, the outcome of the herpes zoster infection neurological was unknown and the outcome of the herpes zoster and lip pustule were not recovered/not resolved. It was unknown if the reporter considered the herpes zoster infection neurological, herpes zoster and lip pustule to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The reporter was a retired nurse practitioner and stated a history of shingles on three separate occasions prior to receiving Shingrix and stated previously receiving shingles vaccine in the past. The 1st dose of Shingrix was administered approximately 2 months ago and scheduled to receive second dose of Shingrix tomorrow that would be day after date of reporting since tomorrow would make 2 months and a day since receiving the first dose of Shingrix. Approximately 4 days ago, reporter stated breaking out with shingles on her 7th cranial nerve affecting the right side of her pallet and her lip. Reporter described current outbreak as the mildest of all previous outbreaks and that it feels like outbreak wants to progress but it was not. Reporter stated that the outbreak runs across top of pallet and had a pustule on lip. Reporter had bloodwork drawn to measure IgG and IgM to determine if immune system was impaired in any way. Shingles outbreak unresolved but getting better. Reporter was comfortable forwarding lab work to Safety. The reporter consented to follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,11/01/2020,,PHM,,,Medical History/Concurrent Conditions: Shingles (Shingles thrice),,,"['Blood immunoglobulin G', 'Blood immunoglobulin M', 'Herpes zoster', 'Herpes zoster infection neurological', 'Oral pustule']",1,GLAXOSMITHKLINE BIOLOGICALS,IM 918139,FL,85.0,F,"shingles in her right eye; shingles the right side of her head; pain; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (25 years before reporting). In October 2020, the patient received the 1st dose of Shingrix. In November 2020, 2 weeks after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and eye pain. On an unknown date, the outcome of the ophthalmic herpes zoster was unknown and the outcome of the shingles and eye pain were not recovered/not resolved. It was unknown if the reporter considered the ophthalmic herpes zoster, shingles and eye pain to be related to Shingrix. Additional information was provided as follows: The patient received the first dose of the Shingrix vaccine around last week of October 2020 in her left arm and about two weeks later she started to have shingles on the right side of her head and shingles in her right eye. The patient's physician instructed for her to be seen at the hospital. At the hospital she was given some treatment. She was not admitted. The patient continued to have shingles and especially the shingles in the right eye was very painful. The patient had shingles about 25 years before reporting and then this was the second time she was having shingles which had not resolved. The reporter consented to follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,10/01/2020,11/01/2020,31.0,UNK,,,Medical History/Concurrent Conditions: Shingles (25 years before reporting),,,"['Eye pain', 'Herpes zoster', 'Ophthalmic herpes zoster']",1,GLAXOSMITHKLINE BIOLOGICALS, 918140,,,M,"Has Bells Palsy as a result; Side of the body on which he received the Shingrix is weak; Sore arm; Felt lousy; First and only dose of Shingrix in June 2020; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In June 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), hemiparesis (serious criteria GSK medically significant), pain in arm, feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the bell's palsy, hemiparesis, pain in arm, feeling bad and incomplete course of vaccination were unknown. It was unknown if the reporter considered the bell's palsy, hemiparesis, pain in arm and feeling bad to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of Shingrix, the patient had a sore arm, and feeling lousy. He did not elaborate on what feeling lousy entailed. Also, the patient's unknown side of the body on which he received the Shingrix was weak. The patient also had bells palsy as a result. Till the time of reporting, the patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter did not consent to follow-up. The patient noted that, he reported this event previously, but call center representative could not find him in the system, or his phone number. He did not wish to proceed with a safety report and did not wish to give me any demographics or further details. The patient wanted to know whether he would have a reaction to COVID 19 vaccine due to his Shingrix experienced. He was referred to his provider.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,06/01/2020,,,UNK,,,,,,"['Facial paralysis', 'Feeling abnormal', 'Hemiparesis', 'Incomplete course of vaccination', 'Pain in extremity']",2,GLAXOSMITHKLINE BIOLOGICALS, 918141,PA,66.0,F,"passed out / passed out for 5 or 10 minutes; she was sweating; shivering; heart palpitations; upset stomach; felt weak for 1 whole day; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 6th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th September 2019, 1 days after receiving Shingrix, the patient experienced upset stomach and weakness. In September 2019, the patient experienced passed out (serious criteria GSK medically significant), sweating, shivering and palpitation. On 7th September 2019, the outcome of the upset stomach and weakness were recovered/resolved. In September 2019, the outcome of the passed out, sweating, shivering and palpitation were recovered/resolved. It was unknown if the reporter considered the passed out, sweating, shivering, palpitation, upset stomach and weakness to be related to Shingrix. Additional details were provided as follows: 12 hours after receiving Shingrix, the patient was sweating, shivering, had heart palpitations, and then passed out. The patient reported, she thought she was passed out for 5 or 10 minutes both times but was not sure. The patient reported the sweating, shivering, and heart palpitations resolved after she woke up from being passed out. The patient also had an upset stomach and felt weak for 1 whole day and then these events resolved. The reporter consented to follow up. For the tolerance of 2nd dose, refer linked case US2020AMR253265.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR253265:same patient (2nd dose)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,09/06/2019,09/07/2019,1.0,UNK,,,,,,"['Abdominal discomfort', 'Asthenia', 'Chills', 'Hyperhidrosis', 'Loss of consciousness', 'Palpitations']",1,GLAXOSMITHKLINE BIOLOGICALS,IM 918143,,,U,"was delirious/talked out of head; fever; slept often; Initial information regarding an unsolicited valid serious case was received from a consumer (patient) via social media on 08-Dec-2020. This case involves a patient of unknown demographics who was delirious/talked out of head (delirium), had fever (pyrexia) and slept often (hypersomnia), after receiving INFLUENZA VACCINE. The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient was delirious, had talked out of head (delirium) (unknown latency) following the administration of INFLUENZA VACCINE. The event delirious was assessed as medically significant as per important medical event (IME) list. On an unknown date, the patient had fever (pyrexia) and slept often (hypersomnia),(non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported as the patient had taken vaccine during college days in 1976 and was totally out of it for 7 days. Patient list wright from not eating but never had the flu since getting that vaccine. The patient was too afraid and not taking flu shot at all. No laboratory data was reported. It was not reported if the patient received a corrective treatment. At the time of report, the outcome was unknown for the events. There will be no information available on the batch number for this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Delirium', 'Hypersomnia', 'Pyrexia']",UNK,UNKNOWN MANUFACTURER,OT 918175,,,U,Patient had swollen lymph nodes under his left arm 3 days after injection was administered. He stayed he had surgery to remove lymph nodes in June 2020.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Lymphadenopathy'],1,MODERNA,IM 918176,NC,44.0,F,"Arm pain at injection site, fatigue, mild headache, swollen lymph nodes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,PVT,"Lamictal, zoloft, multivitamin, clonazepam",none,Epilepsy,,none,"['Fatigue', 'Headache', 'Injection site pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 918177,KY,68.0,F,"riggors, fever,, severe body aches, flank pain, headache, eyes hurt",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,WRK,Ibuprofen,Knee surgery one month prior,No,,No,"['Chills', 'Eye pain', 'Flank pain', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 918178,RI,26.0,M,"Patient was anxious when arrived. After receiving the vaccine, felt light headed and revealed he has ""spells"" of anxiety similar to current experience. Became diaphoretic and needed to lie down.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,None,,None,,Amoxicillin,"['Anxiety', 'Dizziness', 'Hyperhidrosis']",1,MODERNA,IM 918179,PA,43.0,F,"itching, redness and swelling at injection sight. Took Benadryl on 12/31. Reappeared on 1/1, visited Er, got dexamethasone, Pepcid po and bendaryl",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/31/2020,9.0,WRK,"humara fluoxetine lorsartan/hctz wellbutrin xl protonix vit d 50,000 singulair",,"high blood pressure, psoriasis, depression, vit d deficiency",,"cats, dogs, pitted fruit raspberries seasonal","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 918180,NY,39.0,F,"Itchy around the vaccine site, stiff muscle, sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/30/2020,2.0,PVT,Metoprolol succinate Escitalopram,None,None,,NKDA,"['Injection site pruritus', 'Musculoskeletal stiffness', 'Pain in extremity']",1,MODERNA,IM 918181,OH,52.0,F,"Muscle aches, palm size red ring for 3 days, day 4 rash, Diarrhea, vomiting, arm sore 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Singulair 10mg,,Aasthma,,NKA,"['Diarrhoea', 'Erythema', 'Myalgia', 'Pain in extremity', 'Vomiting']",1,MODERNA,IM 918182,RI,53.0,F,"shortness of breath, hypotension, presumed anaphylaxis",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,OTH,patient denies,patient denies,patient denies,,"codeine, erythromycin, sulfa, hydrocodone","['Anaphylactic reaction', 'Dyspnoea', 'Hypotension']",1,MODERNA,IM 918184,MA,60.0,M,Pain at site of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,OTH,"Simvastatin, FlowMax, Omega-3","two, low-grade, low-stage bladder tumors",,,"Erythromycin, Niacin",['Injection site pain'],1,MODERNA,IM 918185,MI,32.0,F,"Painful/sore joints (shoulders and elbows) for two days. Almost went for treatment after about 48 hrs, but got through a rough night and the next morning it was gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,Claritin,None,Urticaria,,None,['Arthralgia'],1,MODERNA,IM 918186,IN,35.0,F,"Moderate local reaction. Swelling, redness, pain, hot to touch, itchy for 5+ days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,None,None,Asthma,,None,"['Erythema', 'Local reaction', 'Pain', 'Pruritus', 'Skin warm', 'Swelling']",1,PFIZER\BIONTECH,IM 918187,,39.0,F,"Mild swelling, pain, and itching at the injection site 8 days after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,01/03/2021,8.0,UNK,cetirizine 10 mg Viactiv 1000 mg calcium/400 IU Vit D,none,none,,"sulfa, ragweed","['Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 918188,FL,58.0,F,"MODERNA COVID 19 VACCINE EUA PAIN TENDERNESS SWELLING/ FATIGUE, HEADACHE, MUSCLE PAIN, JOINT PAIN, CHILLS/ THEN CAME THE ALL OVER BODY RASH AND I STILL HAVE THIS",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,WRK,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pain', 'Rash', 'Swelling', 'Tenderness']",1,MODERNA,IM 918189,IN,60.0,F,"Pfizer-BioNtech COVID-19 Vaccin EUA-. Severe Dizziness, light- headed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,"omeprazole, atorvastatin, pilocarpine, baclofen, synthroid, super c complex",none,,"Flu Vaccine, November 2009, Bells Palsy","penicillin, morphine, cipro",['Dizziness'],1,PFIZER\BIONTECH,IM 918190,MA,61.0,F,Redness to the area after a week. resolved,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,WRK,"Fish Oil, Vit D",none,Hypothyroidism,"Redness, pain to site",none,['Erythema'],1,MODERNA,IM 918191,IL,45.0,F,"Thursday 12/29/20 : Started wheezing, I am using my nebulizer but the wheezing seems to be getting worse My throat also is swollen and red. Fatigue/sleeping a lot Headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PVT,Diclofenac Fluticasone Prop Nose Spray 2 puffs spiriva inhaler Symbicort 160 FREESTYLE LIBRE 14 DAY SENSOR KIT Vitamin D Calcium w Vitamin D COQ10 Vitamin Probiotic Vitamin Protonix/Pantoprazole Montelukast-Singulair lipitor/atorvastatin,Diverticululitis Flare Up,"Diabetic Hypo Thyroid Hodgkins Lymphoma Survivor Chronik NK Cell Leukemia Asthma Heart issues, races and irregular",,Penicillin Erythromyacin Tape/Band Aids Dairy Lactose,"['Fatigue', 'Headache', 'Hypersomnia', 'Pharyngeal erythema', 'Pharyngeal swelling', 'Wheezing']",1,MODERNA,SYR 918192,OH,52.0,F,Very swollen lymph node in front of my left ear.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,WRK,Allegra B12 Amlodipine Citalopram Omeprazole Synthroid Benadryl,,,,Doryx; Biaxin; Etodolac; Omnicef Mushrooms & Mussels,['Lymphadenopathy'],1,MODERNA,SYR 918193,NY,61.0,M,Flue like symptoms but no fever.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,Low dose aspirin.,None,None,,Hazelnuts.,['Influenza like illness'],1,MODERNA,SYR 918194,NH,27.0,F,"I am currently breastfeeding my 11 month old son. On Thursday, December 31st, 2020 (2 days after receiving my vaccine), my son developed a fever x24-36hours and diarrhea that is still on going as of today (1/4/2021). There are no known exposures for my son and his illness. I am reporting this as a possible reaction to the Moderna COVID 19 vaccine I received that could have some how passed through the breastmilk to him.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,OTH,"birth control, prenatal vitamins, vit D supplement, sunflower lethacin supplement",,Breastfeeding,,sudafed,['Exposure via breast milk'],1,MODERNA,IM 918195,OH,39.0,F,"About 1 week after receiving the vaccine (on 12/31/2020) I developed an itchy, raised, and red hive-like rash at the injection site. It got worse over the next day, and I put some steroid cream on it. It went away gradually and was completely resolved by 1/03/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,PVT,Multivitamin,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site urticaria']",1,MODERNA,IM 918196,WV,65.0,M,"redness and swollen to inj site, rash to hands Benadryl given for sysmptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,,,OTH,"acetaminophen 325mg 2 tabs daily, albuterol inhaler 90 mcg 2 puffs q4, prn, asa 81 mg daily, atorvastatin ca 80 mg daily, lisinopril 10 mg daily, budesonide 80/formoter 4.5 inhaler 2 puffs twice a day, cholecalciferol 50, 000 units take 1 c","Malignant neoplasm of skin, vit d def., ischemic cardiomyopathy, COPD, chronic kidney disease, microscopic hematuria, cad, hyperglycemia, hyperlipidemia, etoh abuse, nicotine dependence, polyosteoarthritis, knee pain, cervicalgia, disorder of kidney and ureter, artificial knee joint","Malignant neoplasm of skin, vit d def., ischemic cardiomyopathy, COPD, chronic kidney disease, microscopic hematuria, cad, hyperglycemia, hyperlipidemia, etoh abuse, nicotine dependence, polyosteoarthritis, knee pain, cervicalgia, disorder of kidney and ureter, artificial knee joint",,nka,"['Injection site erythema', 'Injection site swelling', 'Rash']",1,MODERNA,IM 918197,CT,26.0,F,"Arm soreness at injection site, worse than a flu shot and starting an hour after the shot and lasting approx 2 days. Increased phelgm production for approx 24 hours following injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,Allegra allergy medication. Biotin supplement.,,,,"Sulfa based drugs, penicillin","['Injection site pain', 'Productive cough']",1,MODERNA,IM 918198,,48.0,F,"Moderna COVID-19 Vaccine On day 9 after injection, began to get itching at the injection site. Now on day 10 with red area ~ 5 cm x 3 cm. Mild fatigue on day 9 as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/03/2021,10.0,PVT,"Humira (held for 10 days prior to injection), Celebrex, escitalopram, Vitamin D, Biotin/collagen, folic acid, potassium citrate, slow Mag (magnesium), Myrbetriq,","none- occasional sinus fullness, seems to be allergies","Psoriatic Arthritis, idiopathic clotting disorder, ""Short gut syndrome"": s/p biliopancreatic diversion with Duodenal Switch,",,none,"['Fatigue', 'Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 918200,FL,27.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA - Patient witnessed another patient with syncope prior to her injection. She was already anxious about receiving vaccination and this increased her anxiety, though she proceeded with immunization. Patient was in 15 min observation window in a chair and began to feel light-headed like she may pass out. A SWAT was called. With RN assistance, patient was lowered to the floor, with no loss of consciousness. Patient was pale and reported anxiety, racing /pounding heart, and felt hot with facial flushing. Patient was transferred to ED and was noted to be tachycardic (120s), but dropped to 80s. She noted that this episode felt different than her prior syncopal episodes associated with anemia. Patient was observed for 5 hours and discharged to home. Patient returned to ED roughly 2.5 hours later complaining of continued dizziness and unsteady gate. Patient was pale and anxious. Patient reported had not eaten/drank enough during her shift and received vaccine immediately post a stressful shift. Additionally, patient witnessed another patient have syncopal episode prior to her receiving her vaccine which made her anxious. Patient was given IV fluids and had electrolytes replacement. Patient additionally received diazepam. Patient was discharged at 2358 on 12/23. Patient returned to ED on 12/24 at 0239 complaining of near syncope and lightheadedness. Patient had tachycardia and self-reported palpitations. Received IV fluids and observation on telemetry with no rhythm disturbance. Patient discharged 1428 on 12/24. On 12/29, patient returned to ED at 0326 for continued dizziness, fatigue and near syncope. Was admitted for cardiac evaluation. Noted to have unprovoked tachycardia and was discharged with a Halter Monitor to evaluate cardiac symptoms. patient was discharged 12/31 at 1619",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,12/23/2020,12/23/2020,0.0,PVT,Unknown,Unknown,Patient with history of syncope which was attributed to anemia (6-8 episodes in the past). No history of syncope with injections. patient reports increased stress at home and anxiety.,,None,"['Anxiety', 'Blood chloride increased', 'Blood phosphorus decreased', 'Blood potassium decreased', 'Blood thyroid stimulating hormone normal', 'Cardiac telemetry normal', 'Chest X-ray normal', 'Computerised tomogram thorax normal', 'Condition aggravated', 'Dizziness', 'Echocardiogram normal', 'Ejection fraction normal', 'Electrocardiogram ambulatory', 'Fatigue', 'Feeling hot', 'Fibrin D dimer', 'Flushing', 'Gait disturbance', 'Haemoglobin decreased', 'Pallor', 'Palpitations', 'Presyncope', 'Tachycardia', 'Troponin normal']",1,PFIZER\BIONTECH,IM 918201,VA,50.0,F,"Received the injection on Wednesday afternoon. I woke up around 3am with an excruciating headache, started vomiting around 6am and continued until 7:30pm. The headache continued and as of this morning 1/4 the headache is still there and my stomach is not settled completely.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,Wellbutrin,None,None,,None,"['Headache', 'Vomiting']",1,PFIZER\BIONTECH, 918202,,54.0,M,"Patient received the vaccine and had slight chest tightness, had a slight headache and has mild nausea. He worked the day and still has the symptoms at 1:30 pm",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Chest discomfort', 'Headache', 'Nausea']",UNK,PFIZER\BIONTECH, 918203,VA,50.0,F,Pt developed urticaria on both arms 4 hours after COVID vaccine administration. Pt received dexamethasone 10mg IM for treatment and diphenhydramine PO 25 mg. Symptoms subsequently resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,,none,diabetes,,calamari,['Urticaria'],1,PFIZER\BIONTECH, 918204,OH,27.0,F,"I received the Moderna COVID-19 vaccine on Tuesday, December 29th at work and on Wednesday, December 30th when I woke up my entire neck had broken out in hives. I did not have hives anywhere else or any other reaction. After taking 25 mg of Benadryl po and applying hydrocortisone cream, the hives had cleared up about 75%. I continued to use the hydrocortisone cream throughout the day, but the hives/redness had fully cleared up by Saturday, January 2nd.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,None,None,None,,NKA,"['Erythema', 'Urticaria']",1,MODERNA,IM 918205,,44.0,F,"Swollen L armpit, medial, at same side of vaccine. Resolved in 2 days with ibuprofen",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/23/2020,2.0,PVT,,,,,,['Lymphadenopathy'],UNK,PFIZER\BIONTECH, 918206,MA,30.0,F,Circular redness at injection site about 2 inch in diameter.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,01/01/2021,10.0,WRK,,,,,,['Injection site erythema'],1,MODERNA,IM 918207,FL,,M,"Flu like symptoms (fever, chills, aches, fatigue, headache); redness, swelling, warmth and firmness at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Nothing prior,None,None,,none,"['Chills', 'Fatigue', 'Headache', 'Influenza like illness', 'Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Pyrexia']",1,MODERNA,IM 918208,IN,62.0,M,Stuffy nose tingling lips tingling face i took 50 mg of over the counter benedryl..symptoms resolved,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,Quinnipiac hctz......atorvastatin...asa 80mg,,Hypertension....obese....hyperlipidemia..pre diabetic,Age 2.....penicillin,Pcn.,"['Nasal congestion', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 918209,VA,52.0,F,Arm soreness Arm swelling Headache Right side neck pain Bumps on both cheeks (face),Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,Xanax Zoloft Atenol,NonFa,Fatty liver disease,,NKA,"['Headache', 'Neck pain', 'Pain in extremity', 'Peripheral swelling', 'Rash', 'Rash papular']",1,PFIZER\BIONTECH,SYR 918210,VA,31.0,F,Patient experienced feeling flushed and nauseated after receiving covid vaccine injection. Declines ED evaluation. No further symptoms reported on 12/19 follow-up,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,,,,,,"['Flushing', 'Nausea']",UNK,PFIZER\BIONTECH, 918211,FL,52.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to benzonatate. Patient answered ""no"" to questionnaire about allergic reactions prior to vaccination. 11 minutes after vaccination, patient reported tingling of lips and swelling of face. Developed hoarseness. SWAT was called and patient given benadryl and taken to ED (1055). Patient received steroids and H1/H2 blockers in addition to epinephrine. Patient brought to ICU for monitoring. Patient continued on therapy and was discharged 1/2 at 1113. Patient returned to ED on 1/3 at 1558 with macular papular rash on leg, chest and back with itching on eyelids and face. No respiratory involvement. Patient given benadryl and predinisone and discharged from ED at 2016.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,12/31/2020,12/31/2020,0.0,PVT,Unknown,Unknown,"Asthma, OSA, history of anaphylaxis, GERD",,Benzonatate - brochospasm and laryngospasm requiring intubation NSAIDS - petichiae Keflex - rash - tolerates cefepime Lanolin - rash Septra - rash,"['Dysphonia', 'Eyelids pruritus', 'Intensive care', 'Paraesthesia oral', 'Pruritus', 'Rash', 'Rash maculo-papular', 'Swelling face']",1,PFIZER\BIONTECH,IM 918212,MI,46.0,F,"Generalized body aches that evening, same day as injection. Woke up the next morning, 12/31/2020 with a headache, fever of 100.2, and fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None,None,None,,None,"['Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 918213,OH,59.0,M,Patient had chills and a fever that started on 12/30/2020 @ 12:00am. The highest fever recorded was 100.6. He took Tylenol on 12/30/2020 @ 6:00am. His symptoms resolved on 12/30/2020 at 8:30pm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,Blood pressure medication - patient is unsure of the name,None,Hypertension,,"Patient knows there is a blood pressure medication that puts him into liver failure, but he is not sure which one","['Chills', 'Pyrexia']",1,MODERNA,IM 918214,MD,43.0,F,Anterior cervical lymphadenopathy on the ipsilateral side of the vaccination. It seemed to begin on the third day but was most pronounced and painful on the fourth day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/02/2021,4.0,WRK,none,none,none,,none,"['Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 918215,NC,30.0,F,"Increasing redness and itchiness, swelling, and discomfort at injection site on R arm, delayed response not present at time of injection, symptoms began 12/27/20 and gradually worsened since then, no improving. Tried Benadryl and cold compresses, as well as Tyelnol.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/27/2020,5.0,PVT,"Gianvi, Levothyroxine, Loratadine, Pristiq",none,hypothyroidism,,,"['Injection site discomfort', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling']",1,MODERNA,IM 918216,SC,39.0,F,"Body aches, stomach cramping, rash on abdomen, arms. Start of period early (last period 12/22). Itchy all over",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,SEN,NONE,none,none,,none,"['Abdominal pain upper', 'Pain', 'Pruritus', 'Rash']",1,MODERNA,SYR 918217,ID,55.0,F,"Patient developed muscle twitching, fatigue, dizziness and headache minutes after vaccine was given. Day after vaccine given, patient developed small red area around injection site that also had swelling and was warm to touch. No fever or other complication.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Dizziness', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Muscle twitching']",1,MODERNA,IM 918218,MA,38.0,F,Hives and facial swelling. Swelling within the ears. Migrain. Nausea.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,Celexa 40 mg Seroquel 40 mg,,,,Strawberries,"['Ear swelling', 'Migraine', 'Nausea', 'Swelling face', 'Urticaria']",1,MODERNA,IM 918220,NY,52.0,F,"Severe joint pain, especially in hips, knees and hands lasting approximately 72 hours after first onset of symptoms. Treatment Tylenol/NSAIDs. Resolved on its own.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Edarbyclor,Hypertension,Chronic neck and back pain,,Shellfish,['Arthralgia'],1,MODERNA,IM 918221,VA,31.0,F,"Upon injection, vaccine leaked out of syringe at hub site. Stopped injection after noticing after ~0.1mL expelled. Syringe removed, needle noticeably noted to have a curve and retracted into the syringe partially engaged safety.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,,,,,,['Syringe issue'],1,PFIZER\BIONTECH, 918222,OH,39.0,F,"I received the COVID vaccine on Monday Dec. 21, 2020 at 14:30. By 17:00 I was not feeling well. I was tired, had a headache, muscle aches, nausea and a fever of 101 F. The headache, low grade fever and significant malaise continued through Tues Dec 22 and Wed Dec 23. On Thursday morning Dec 24 at 2:30 AM, I woke from sleep with the urge to use the bathroom. I suddenly felt light-headed and dizzy and had a diaphoresis that soaked my hair and PJs. Fortunately my husband who is a nurse anesthetist helped me through the episode safely and was able to get me back to bed. I am not sure if that event was related to the vaccine or if I happened to be a little dehydrated and had a vaso-vagal event. I did not take any medications because I was allowing my body to have a natural response to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,"Amitriptyline 25 mg q HS, Gabapentin 300 mg q HS and Cetirizine 10 mg q HS. Vit D 5000 U, Vit C and Magnesium supplements q AM",None,"Auto-immune hyperinflammatory disorder, proctalgia fugax, uterine fibroids s/p hysterectomy(2016), RVOT PVCs s/p cardiac ablation (2006), TMJ, MVA x2 with concussion and neck pain (1996 & 2015), cervical radiculopathy","Fever, chills, muscle aches, malaise lasting 3-4 days with influenza vaccinations",Adhesive-contact dermatitis PCN-terrible yeast infection that required 3 rounds of treatment and a wound care consult,"['Dizziness', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,IM 918223,VA,52.0,M,"Woke up with a case a vertigo that lasted 30-45 minutes, Headache that lasted around 6 hours that same day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,PVT,None,None,None,,None,"['Headache', 'Vertigo']",1,MODERNA,IM 918224,OH,45.0,F,"2 Red Area-, itching, burning-the size of a golf ball, the other the size of a quarter- Located at the front of my neck I had vaccine on 12/30/20 at 1:30 pm, and woke up on 01/01/21 at 7am with the red areas.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,SEN,Vita fusion Fiber Well Gummies-5g daily Women?s One a Day Multivitamin-daily,None,None,,Sulfa Penicillin,"['Burning sensation', 'Erythema', 'Pruritus']",1,PFIZER\BIONTECH, 918225,ID,53.0,M,Patient developed a headache one to two hours post vaccination that lasted approximately 24 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,,,,['Headache'],1,PFIZER\BIONTECH,IM 918226,NY,57.0,F,"I felt like I was having palpitations, and my blood pressure shot up to 169/119.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/21/2020,0.0,PVT,"ASA 81mg, HCTZ, pantoprazole, metformin, trulicity, atorvastatin, vitamin D",none,"diabetes, hypertension, GERD, hiatal hernia, small vessel disease",,none,"['Blood pressure increased', 'Palpitations']",1,PFIZER\BIONTECH,IM 918227,MI,67.0,F,"About 6 hours after receiving dose, experienced aching in both arms that extended down into both hands - hands was resolved by next morning. Achiness in both arms remained x 48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PUB,IWI Algae pills - Omega three Super Beets,None,none,,All Seafood Avocados,['Pain in extremity'],1,MODERNA,IM 918228,NY,32.0,F,"* TESTED POSTIVE FOR COVID ANTIBODIES 06/2020 - 'STILL HAVE RESIDUAL COUGH' 12/21/2020 - VACCINATION 12/22/2020 9:30 WERE AT WORK; FELT SUPER FLUSHED, SOB, COULDN'T FOCUS, FELT FEVERISH, FELT NAUSEOUS. OCCUPATIONAL HEALTH REFERRED TO URGENT CARE; DR STATED 'NOT TYPICAL RESPONSE'; COVID TEST; NEGATIVE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,,,,,,"['Disturbance in attention', 'Dyspnoea', 'Flushing', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,SYR 918229,MA,39.0,F,12/26/20 started to experience covid -19 symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/26/2020,3.0,WRK,,,,,,"['Illness', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 918230,ID,46.0,M,patient developed fatigue approximately 24 hours after immunization that lasted for about 24 hours. Patient also had soreness at injection site 24 hours after that lasted 24 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,,,,,,"['Fatigue', 'Injection site pain']",1,PFIZER\BIONTECH,IM 918231,OH,44.0,F,"first 24 hours: nausea, left arm pain and heaviness 1/2/2021 until present: body aches, very strong headache, sore throat, very tired, coughing with pain, flushed, feel as if my eyes are on fire.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,OTH,coumadin gabapentin Zyrtec,,RLS Hx of pulmonary embolism seasonal allergies,,none,"['Cough', 'Eye irritation', 'Fatigue', 'Flushing', 'Headache', 'Limb discomfort', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH,SYR 918232,KY,35.0,F,"6 days after injection, left supraclavicular lymph node swelling and tenderness and axillary tenderness and swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,PVT,Zoloft Multivitamin Colace Flonase,None,Depression,,No,"['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 918233,XB,52.0,F,"52 year old female received the Pfizer vaccine on 30 Dec 2020. Noticed a slight left sided facial droop as left lower lip numbess on 31 Dec 2020, which has become more pronounced over the past 2 days. She states she spoke to the nurse hotline right before speaking to me who told her to go to the ED (she was on her way). Denies any extremity weakness, numbness, HA or dizziness. No pain to face or ear. Speech clear on the phone. No recent illness or history of Bell's palsy. NKDA or any prior adverse reactions to immunizations.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,MIL,"Ropinirole 1 po BID prn, Botox for hyperhidrosis (see below)",no,RLS Frey Syndrome,,NKDA,"['Chest X-ray normal', 'Computerised tomogram head', 'Computerised tomogram normal', 'Facial paralysis', 'Hypoaesthesia oral']",1,PFIZER\BIONTECH,IM 918234,GA,49.0,M,Client called clinic on 12/30/2020 in the am requesting us to call in prescription pain medication due to having severe arm pain at the injection site. He stated he had not slept any for the last two nights. Encouraged client to see his PMD if he was in the kind of pain that required a Rx pain medication. Encouraged client to ice down his arm for pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PUB,Not known,None,Not known,,NKDA,"['Injection site pain', 'Insomnia']",1,MODERNA,IM 918235,NH,37.0,F,"Patinet is a 37 y.o. female ER nurse who received her Covid vaccine just prior to arrival. While being observed at the vaccine site, she developed itching and a rash. She was brought down to the ER for evaluation. Mainly she is itchy all over. She notes a rash across her chest. But she has no cough shortness of breath wheezing. There is no problem swallowing there is no facial swelling. She does not have a history of anaphylaxis, or medication allergies. Review of Systems Constitutional: Negative for chills, diaphoresis and fever. HENT: Negative for congestion, trouble swallowing and voice change. Eyes: Negative for redness and itching. Respiratory: Negative for cough, shortness of breath, wheezing and stridor. Musculoskeletal: Negative for myalgias. Skin: Positive for rash. Pruritus Allergic/Immunologic: Negative for environmental allergies, food allergies and immunocompromised state. Neurological: Negative for headaches. 01/04/2021- Speaking with the patient she states noticed ""hives"" accross chest, right lower extremity, and left upper extremity.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,No.,Healthy,,The patient denies any allergies or reaction to medications.,"['Dermatitis exfoliative generalised', 'Hypersensitivity', 'Pruritus', 'Rash']",1,MODERNA,IM 918236,OH,29.0,F,"I am breastfeeding-Milk supply significantly decreased (<50% of typical) day of vaccine. Milk supply still decreased 5 days later,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,88mcg levothyroxine prenatal lactobacillus Calcium+D,none,hypothyroidism,,none,['Suppressed lactation'],UNK,MODERNA,SYR 918237,ID,45.0,F,Patient developed fatigue approximately 24 hours after immunization that lasted a couple days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,,,,,,['Fatigue'],1,PFIZER\BIONTECH,IM 918238,OH,43.0,F,"Approx 25 min after injection I became dizzy and my HR went to the 130?s, at around 30 min post injection my tongue started to swell",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,Multivitamin,None,None,,Codiene- vomiting,"['Dizziness', 'Heart rate increased', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 918239,MT,89.0,F,"Left arm warm, red, sore, swelling noted",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/03/2021,4.0,SEN,,,,,"PCN, Sulfa, ASA. Codeine, Meperidine","['Erythema', 'Pain in extremity', 'Peripheral swelling', 'Skin warm']",1,MODERNA,IM 918240,NC,50.0,F,"dizziness, itching/small hives on forearm (not at injection site) , 30 minutes after vaccine given. Vitals monitored, were normal, sent home and advised to take Benadryl. More hives on upper lip/chin appeared 36 hours after vaccine given. Patient was at home, self-treated with benadryl, zyrtec, famotidine and ice pack applied to area.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,"zyrtec, famotidine, albuterol , flovent, flonase, ipratropium nasal spray, levothyroxine, verapamil",,"asthma, hypothyroid, migraines",,"NSAIDS: angioedema, hives KEflex: hives","['Dizziness', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 918241,KS,31.0,F,Significant neck and upper back pain as soon as 1 hour post vaccine lasting until at least 24 hours - tylenol and heat/ice (no change) chills without fever overnight the night of - no treatment soreness in arm 1 hr post to up to its worst at 24 hours later when I could not abduct >90 degrees for 24 more hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Adderall XR Acyclovir Women's Multivitamin Melatonin PRN,none,ADHD Herpetic whitlow,,Contrast IV dye - hives,"['Back pain', 'Chills', 'Neck pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 918242,NY,37.0,F,"I got moderna COVID19 vaccine on 12/26/2020. Day 1-3 local pain and swelling, no redness. All resolved after day 3-4. Very tired all week post vaccine,. Day 5-6 noticed ipsilateral axillary lymph node swelling. On day 7 post vaccine I got a localized area of itching swelling and redness as if I had been bitten by a few mosquitoes at injection site that was new. Milder on day 8, less itchy and swollen, but still red and a little raised. Mild shortness of breath.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,OTH,"lexapro 10mg daily, magnesium 400mg daily, fish oil, vit D 1000iu, biotin",none,anticardiolipin antibodies (asymptomatic),,"penicillin (rash in childhood), latex sensitive","['Dyspnoea', 'Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Lymphadenopathy']",1,MODERNA,IM 918243,TX,80.0,M,Really bad headache first 3 days Horrible Chills still ongoing Disoriented and almost like hallucinations Most interesting randomly talking to himself. I mean like a full conversation with someone that isn?t there. He also sometimes feels like when holding something he doesn?t see it or feel it and drops it or vice versa ?.. thinks holding something and isn?t Balance is off Shortness of breath No fever thank goodness and taste and smell are normal,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,Symbicort inhaler provental inhaler blood pressure medication zyrtec D mylanta as needed for bone joint pain gabapentin or tramadol,None,COPD high blood pressure otherwise healthy,,none,"['Balance disorder', 'Chills', 'Disorientation', 'Dyspnoea', 'Hallucination', 'Headache']",1,MODERNA, 918244,TX,53.0,F,"After got vaccinated, I walked out of the clinic to monitoring area approximately 15 walking steps, I felt a little off balance but I was able to make to the chair and sat down. Few seconds later, my heart beat increased faster and faster, my neck turned red. I called for help, they gave me some apple juice to drink and talked to me. About 5 minutes later, my heart beat went back to normal rate and my redness turned back to normal skin color. I only had a little vertigo symptom but I was able to manage myself. About 2 hours later, symptoms disappeared and I was back to my normal health",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,WRK,Levothyroxine 125 mcg,Hypothyroidism,no chronic health condition,,none,"['Balance disorder', 'Erythema', 'Heart rate increased', 'Vertigo']",1,PFIZER\BIONTECH,IM 918245,IA,54.0,F,"12/31/20 - cough, sneezing, weakness. Felt ill all weekend. 1/3/21 - called Employee Health with low-grade fever, chills, nausea, weakness and elevated blood pressure 165/104, which had come down by the afternoon to 155/95",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,,,,,,"['Asthenia', 'Blood pressure increased', 'Chills', 'Cough', 'Malaise', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative', 'Sneezing']",1,PFIZER\BIONTECH,IM 918246,FL,36.0,F,Developed Tachycardia approximately 40 minutes post vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,Unknown,None,None,,Adipex,['Tachycardia'],UNK,MODERNA,IM 918248,ID,23.0,M,patient developed fatigue day after vaccination that lasted about 1 day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,,,,,,['Fatigue'],1,MODERNA,IM 918255,,,F,"violent, delayed reaction; This case was reported by a consumer via other manufacturer and described the occurrence of delayed type hypersensitivity in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included allergy, bee sting hypersensitivity and allergy. Previously administered products included Epipen. On an unknown date, the patient received Shingles vaccine. On an unknown date, 12 hrs after receiving Shingles vaccine, the patient experienced delayed type hypersensitivity (serious criteria hospitalization). On an unknown date, the outcome of the delayed type hypersensitivity was unknown. It was unknown if the reporter considered the delayed type hypersensitivity to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had allergies to preservatives,any drug that ends in ""caine"" (lidocaine, prilocaine etc),bee stings, and tar. Patient carried Epipen and had a hesitation to receiving the Covid 19 vaccine It was reported that patient received the 1st dose of Shingrix and 12 hrs after the vaccination patient had a violent, delayed reaction and patient was sent to the hospital.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Allergy; Bee sting hypersensitivity,,,['Type IV hypersensitivity reaction'],UNK,UNKNOWN MANUFACTURER, 918262,GA,50.0,F,"After receiving the vaccine, my arm was in a lot of pain. Then that night and the next day, it was extreme pain, I couldnt lay on it. Then about 3-4 days later, the color is blue and black. Then I started having cold symptoms. Like a head cold. On my left side, my arm and my leg is sore. In addition, my face broke out too. I did not go to the ER. I let Employee health examine my arm . No ER visit",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PVT,"Vitamin C, Omega 9,6 and 3, Nail hair and skin vitamin, Biotine, Vitamin D3, Vitamin B, DHEA. Progesterone, and Estrogen.",No,No,,"Food: Most food grown on trees , Product: Dish Detergent","['Nasopharyngitis', 'Pain in extremity', 'Rash', 'Skin discolouration']",UNK,PFIZER\BIONTECH, 918263,MT,90.0,F,"Warm to touch, redness, hard area, sore to touch",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,SEN,,,Alz. Dementia,,"Biaxin, Beta, Methadone, Triamcinolone","['Erythema', 'Pain of skin', 'Skin induration', 'Skin warm']",1,MODERNA,IM 918264,ID,51.0,M,patient developed headache and arm pain day after vaccination. Patient stayed and worked from home on this day as a result.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,,,,,,"['Headache', 'Pain in extremity']",1,MODERNA,IM 918265,TX,44.0,F,"1/2/21 @ 1030: EE called to report she received the vaccine on 12/31/20 between 1030 and 1100. And then around 2330 on 12/31/20 she experienced facial swelling, arm swelling, headache, chills, and dizziness. EE stated she felt it was an allergic reaction to the vaccine and took Benadryl for the next 24 hours to help with the symptoms. EE reported she hasn't had anything since the initial 24 hours, but is concerned about taking the next vaccine. Encouraged EE to contact PCP regarding concern for taking next vaccine. After speaking with Administration, EE encouraged to report vaccine side effects to CDC via V-Safe (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,Unknown,"Chronic illness, details not disclosed",Unknown,,None disclosed,"['Chills', 'Dizziness', 'Headache', 'Peripheral swelling', 'Swelling face']",1,MODERNA,IM 918266,NY,23.0,F,about two inches around the site was red and outlined. Felt slightly raised and was itching. Is still red today 1/4/21,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/30/2020,4.0,PVT,Birth control Levothyroxine Vitamin B Vitamin C,None,Hypothyroidism,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 918267,MA,59.0,F,"C/O of ""smokey vision"", outside in parking lot. Sat in car for about 10 minutes before coming into the building. A&O, ambulatory, denies dizziness, HA or lightheadedness. States feels SOB with exertion, ""heaviness in trachea"" increasing with inspiration. Hand off to EMTs. EKG performed, Sinus Tach 108 initially then NSR 80s-90s with occ MF PVCs, couplets. BP 162/94, O2SAT 100% RA, BS POC 208. Patient brought to ER by EMTs",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,WRK,Proair at 11:30AM,,"Asthma, OSA (not using CPAP)",,"Sulfa, PCN, Darvon","['Dyspnoea exertional', 'Electrocardiogram', 'Oropharyngeal discomfort', 'Visual impairment']",1,MODERNA,IM 918268,NJ,56.0,F,"Within 10 mins. Tongue was tingling lips were swelling and tingling left arm fingers were tingling , headache",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,WRK,"Edarbi, metformin farxiga Lipitor vitamin d c red rice yeast pro tonic",,"Diabetes, htn ,",,Penicillin,"['Headache', 'Lip swelling', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,SYR 918269,NC,58.0,F,"Itching, redness and swelling on the injection site. Dr. Prescribed antiniotic Bactrim DS 800-160 Tab",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PVT,"Synthroid, Zertek, Sudafed, Lexapro, acid reducer, Lipitor, probiotics, multivitamins, colon cleanse, Omega fish oil.",,Hypothyroidism,,"Penicillin, prednisone","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 918270,KY,39.0,F,"Chills and shaking consistent with flu-like symptoms began about 12 hours following vaccination. The next morning, I had a headache and vomited about 5 times. Over the next several hours, I began to feel better and by that evening, was feeling pretty much normal, except for some lingering fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Escitalopram 5 mg, multivitamin, calcium + D, vitamin C",none,none,,Sulfa--rash,"['Chills', 'Fatigue', 'Headache', 'Influenza like illness', 'Tremor', 'Vomiting']",1,MODERNA,IM 918271,AZ,56.0,F,"This patient is a 56 y.o. female presenting to the emergency department with a chief complaint of a possible reaction to the COVID vaccine onset 2 days ago. The patient states that she has had a fever, chills, adenopathy, and body aches since her vaccination. Her highest recorded temperature was 101F, and she has been taking Tylenol. She states that her biggest concern is the adenopathy under her right armpit which is painful to touch. She denies any masses. She saw her PCP on 12/24 and had blood work done, which showed an elevated white count of 17.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,01/01/2021,31.0,PVT,"nexium, glimeperide, norco, ,etformin, valsartan-HCTZ","Unknown, leukocytosis at PCP office 12/24, hypokalemia","colorectal cancer, tubal ligation, appendectomy",,"Latex (hives), penicillins (unspecified)","['Chills', 'Lymphadenopathy', 'Pain', 'Pyrexia', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 918272,ID,43.0,F,patient developed arm pain day after vaccination that lasted about 1 day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH,IM 918273,MI,35.0,F,"Left arm soreness, Headache 30 mins after, Fever 100.9 T 5am and 9am, monitoring until now",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/04/2021,1.0,PVT,Acetaminophen,None,Protein S deficiency,,NKA,"['Headache', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 918274,MD,53.0,F,After initially receiving vaccine 12/28/2020 my arm was sore and slightly red for approx 2 days and resolved on 12/30/20. When I awoke this morning my right shoulder ached and I thought massage might make it feel better - at that time I noted it was swollen and warm tender to touch at site and again appeared red. I did report this to the clinic who administered vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/04/2021,7.0,PUB,none,none,none,,Penicillin- hives,"['Arthralgia', 'Erythema', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 918275,ID,41.0,M,Patient developed arm soreness at injection site day after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,,,,,,['Injection site pain'],1,MODERNA,IM 918276,MI,54.0,F,"Migraine for 2 days controlled with medication, Severe swollen eyes with discharge from eyes, itchy, red watery eyes began the evening of the vaccine and ongoing. using BENEDRYL and ALLEGRA to decrease symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,"Daily vitamin, Omeprazol",none,Asthma,,"Peanuts, dust, soy protein, mold, grass, pet hair","['Eye discharge', 'Eye pruritus', 'Eye swelling', 'Lacrimation increased', 'Migraine', 'Ocular hyperaemia']",1,MODERNA,IM 918277,FL,73.0,M,"Weakness, almost paralysis both lower extremities worse than baseline paresis from ms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,OTH,"Ocrevus, ramipril, creator, ampyra",,Multiple Sclerosis,,Demerol,['Muscular weakness'],2,PFIZER\BIONTECH,IM 918278,VT,57.0,F,"Arm itchy at injection site, warm feeling at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,,,,"['Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 918279,MA,44.0,F,"Patient c/o feeling tachycardia, flush and dizziness, flushness upper torso neck region and bilateral upper arms. Rash/hives not present. Placed on stretcher , monitored immediately with BP 156/100, HR 88, O2 99%, alert and oriented x3, verbalizing clearly. Placed on EKG monitor, noted in NSR 80. POC 102. Shortly after at 1001, redness subside ,briefly noted with tingling of bilateral feet and hands for only seconds. Patient was monitored for 40 minutes, returned to baseline 142/81 HR 58 O2 100%. Nutrition given . Discharged to home, ambulatory feeling well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,,,,,,"['Blood pressure increased', 'Dizziness', 'Electrocardiogram', 'Flushing', 'Paraesthesia', 'Tachycardia']",1,MODERNA,IM 918280,FL,32.0,F,"Asthma-like fatigue, cough due to fatigue, mild.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,WRK,B-12 vitamin and D3 vitamin,None,None,,None,"['Cough', 'Fatigue']",1,MODERNA,SYR 918281,NY,57.0,F,"Noticed itching and slight rash on distal portion of extremities the evening of Dec. 30, rash became worse over next few days and became more inflamed/raised even with Benadryl taken as directed on box. I went to urgent care on Jan 1, 2021 and was started on Steroid taper of 60-40-20 each dose for 3 days. Improvement noted after 2nd steroid dose. No respiratory involvement with vaccine or rash episode",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/30/2020,4.0,PVT,"Symbicort inhaler, albuterol inhaler prn, Lipitor, vitamin D, cranberry tablets, Allegra, Metformin,",No illnesses,"Pre-diabetic, Asthma",,"latex, cherries, peaches","['Pruritus', 'Rash']",1,MODERNA,IM 918283,TX,47.0,F,Modern a covid 19,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,PHM,75 mg amitriptyline Doxipen,None,Insomnia,,Procardia Macrobid,['Unevaluable event'],1,MODERNA,IM 918284,NY,23.0,F,Moderna vaccine received on 12/21 from my workplace. Rash (reddened skin not raised) appeared after vaccine was given (within 24hrs) the size of a quarter and was gone 3 days later. Now on 1/3 the rash (red bullseye not raised) came back the size of a baseball and is warm to the touch. Went to urgent care and physician called it a delayed adverse reaction to the moderna vaccine 1st dose,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,01/03/2021,13.0,WRK,Junel birth control,None,None,,None,"['Rash', 'Skin warm']",1,MODERNA,IM 918285,IA,40.0,F,"I got the shot, didn?t feel it at all so it went good. I went to the bathroom and went pee and got my arm back in my long sleeve shirt under my scrub top. I wasn?t anxious about getting the vaccine. Then I went to sit down and be monitored. After about another minute I felt very weird like a warm feeling going all over my body. I started pulling my mask away from my face to get a deep breath. Then I broke out in a sweat from head to toe. I think I became pale (I apparently didn?t look good). I started feeling more ?weird? as I had never felt this way before and I stood up to walk because the nurse there wanted me upstairs near the ED but I was weak so I sat down and had tunnel vision. After that it?s a bit of a blur. After I stopped sweating I got very cold and shaky but vitals were ok. It scared me because I have never had a reaction before to a vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,None,None,None,,Possible penicillin. A rash from oral PCN about 15 years ago.,"['Asthenia', 'Feeling hot', 'Hyperhidrosis', 'Nervousness', 'Pallor', 'Tunnel vision']",1,MODERNA,IM 918286,NJ,50.0,F,"fever 100.6- 100.5, chills, headache, general weakness, sweating, and loss of appetite.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,N/AN,,,,"['Asthenia', 'Chills', 'Decreased appetite', 'Headache', 'Hyperhidrosis', 'Pyrexia']",1,MODERNA, 918287,VT,44.0,F,"felt hot, prickly, right arm red. Later felt chest tightness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/18/2020,0.0,PVT,,,,,,"['Chest discomfort', 'Feeling hot', 'Paraesthesia', 'Skin reaction']",1,PFIZER\BIONTECH,IM 918288,TN,76.0,F,"Starting on Thursday, Dec. 31, patient began having shoulder and neck tightness. That night patient began having chills, and noticed redness at the vaccine sight and then the redness started streaking. Also complaints of itching at the vaccine sight. Started taking Tylenol for the two days following the vaccine, states feels like it is improving. Referred to PCP for evaluation. Has appt. Monday, January 4th",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/31/2020,2.0,PUB,"Elderberry PO Daily PRN, Vit. D3 5000 units PO daily, Vit. C PO daily, Losartan 100 mg PO daily, Metformin 500 mg PO daily, Amlodipine 5 mg PO daily",None,Hypertension,,None,"['Chills', 'Injection site erythema', 'Injection site pruritus', 'Injection site streaking', 'Muscle tightness']",1,MODERNA,IM 918289,NH,46.0,F,"Triage for COVID 19 SEVERE post Vaccine Reaction VAERS reportable Your concerns: Vaccine at noon without immediate effect. Driving home at 1400 developed itching and redness at scalp, face, neck, chest, back, arms and sides. Reports that she did not feel warm but looked like she had a sunburn. It appeared to fade over the next two hours but re-occurred at 1700 with all previous symptoms. She took 50mg of Benadryl and went to sleep. She woke at 0200 the re-occurrence of all symptoms, she did not take any Benadryl as that would make her too sleepy to come to work. The symptoms subsided and when we spoke at 1050 she had only small bumps/hive like spots on her fore arms and cleavage. They do not itch or burn at this time. Discussed with PA and Dr. after which I spoke with patient again regarding pending plan. She will call the clinic if she has any further symptomatic episodes in the near future. We will investigate moving her second dose ahead 2 days from 1/12/2021 (day off) to 1/14/2021 this way she will be here at work should it happen again, she works 0630-1900. Med provider will consult with allergy to determine if further steps are needed for dose #2. Dept: Respiratory Therapy Have you missed work? #shifts: none Did you seek emergency care? none Date and Time of Vaccine: 12/22/2020 at 1200 Age at time of vaccination, 46 years 6 months Sex: female Was the vaccine received at facility? yes Site of vaccine (LD or RD): RD Type of Vaccine Pfizer (X ) Moderna ( ) Other _______________ 1st or 2nd dose: first When did your symptoms start? 12/22/2020 at 1400 Please note reported symptoms yes or no, these symptoms are considered mild to moderate and are NOT VAERS reportable Injection site pain no Tiredness no Headache no Muscle Pain no Chills no Joint Pain no Fever (note temp if known) no Injection Site Swelling no Injection Site Redness no Nausea no Feeling Unwell no Swollen Lymph Nodes (lymphadenopathy) no Other: no Employee reports THE FOLLOWING SEVERE post vaccine ADVERSE reactions (reportable): Difficulty breathing no Swelling of your face and throat no A fast heartbeat no A bad rash all over your body yes, see above Dizziness and weakness no If COVID-19 symptoms persist and/or worsen beyond 48 hours consider COVID-19 testing Treatment/Advise: see above Plan: see above If employee was vaccinated at another facility, they need to contact that facility , it is an expectation that the facility that gave the vaccine complete the VAERS report. N/A Employee verbalizes understanding and agreement with plan. yes VAERS report is completed electronically vaccine given at facility. Pending further review. 12/24/2020 01:51pm Follow up to VAER 12/23/2020 Patient called this morning to update regarding vaccine reaction. Yesterday she went home and did some shoveling. Later, around 1900, she developed a itchy, red rash that started on her chest and the right side of her neck which later covered her entire body. The skin on her face was bright red and very hot to the touch, there were small raised hives on her face which were likened to 'petechia if they were raised'. She took pictures of the raised/red areas. She took 50mg of Benadryl and went to sleep, when she woke at 0230 she was asymptomatic. Regarding the bumps on her forearms and cleavage, she has residual mottling on her arms. Updated providers.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,none revealed on consent form,none revealed on consent form,none revealed on consent form,,reported prior anaphylaxis to bee sting during post vaccination interview,"['Erythema', 'Livedo reticularis', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 918290,KY,35.0,F,"Moderna vaccine given 12/28/2020, 6 days after injection have left supraclavicular lymph node swelling and axillary swelling and tenderness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,PVT,ZOLOFT MULTIVITAMIN COLACE FLONASE SOOLANTRA,NONE,DEPRESSION ROSACEA,,NO,"['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 918291,PA,61.0,F,"Extreme fatigue, weakness, lightheaded, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/04/2021,1.0,WRK,Sertraline Ibuprofen famotidine Exemestane,NONE,Irritable bowel syndrome Anxiety,,PCN,"['Asthenia', 'Dizziness', 'Fatigue', 'Malaise']",1,PFIZER\BIONTECH,IM 918292,MO,24.0,F,"Began noticing itching and redness on left had on 1/3 PM. When I woke up on 1/4 the itching in the had was persistent and the redness was about the same. I also noticed a raised, red patch of skin on my right anterior ribs. The rash on the ribs is less itchy than the hand.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/03/2021,11.0,WRK,"Adderall 20mg XR vitamin D, B12 Calcium, biotin, cranberry supplement, probiotic",common cold roughly two weeks prior to vaccination,none,,none,"['Erythema', 'Pruritus', 'Rash papular']",1,PFIZER\BIONTECH,IM 918293,TX,47.0,F,"receive vaccine on 12/24/2020 arm was red and sore few days. then on 1/1/2021 at injection site a rash developed and had HA, tired , weakness, chills. I continue to feel this way on 1/4/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/01/2021,8.0,PVT,"Tylenol 500mg, Tramadol BID, nortriplin 50mg bid,",none,fybromyalgia,,none,"['Asthenia', 'Chills', 'Erythema', 'Fatigue', 'Headache', 'Injection site rash', 'Pain in extremity']",1,MODERNA,IM 918294,KY,40.0,F,"About 1 hour after receiving my first dose of the Moderna vaccine for COVID-19, I started feeling extreme pain in my left shoulder and arm, where the shot was administered. The pain continued to intensify throughout the day and night and was 10/10 on a pain scale. In addition, I began to lose my ability to lift my left arm or use it. It became so weak that I had to use my right hand/arm to pick up my left arm to move it. My left arm was 'hanging and drooping' and my left shoulder was very noticeably lower then my right shoulder. I called my primary care and employee health. My primary care doctor advised me to take advil and go to urgent care if the pain persisted and worsened. I could not sleep at all that evening of 12/29/20 because the pain was so intense and I had to keep picking my left arm up with my right arm to keep re-adjusting to try and get comfortable. The next morning I went to an orthopedic urgent care where I was diagnosed with nerve damage from the shot and prescribed Methylprednisolone 4mg dosepack. The doctor who saw me explained that he could not assess the extent of the damage at this time because my nerves were so agitated and inflamed. He scheduled a follow up visit with me for Thursday, January 7th and stated he will then proceed with an MRI and further investigation to assess the extent of the nerve damage. During the days that followed my immunization, I was unable to do anything with my left arm and was dependent on my husband to help me get dressed, showered, household chores, etc. It is unknown at this time whether this will be temporary or permanent damage and disability.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,MIL,"Buproprion, trazadone, topomax, vitamin D, probiotic, multi-vitamin",None,"Depression, Factor V Leiden heterozygous",,"z-pack, biaxin","['Injected limb mobility decreased', 'Injection site pain', 'Loss of personal independence in daily activities', 'Muscular weakness', 'Nerve injury', 'X-ray normal']",UNK,MODERNA,IM 918295,TX,51.0,F,"swelling, redness that started 1 wk after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/31/2020,7.0,PVT,"Valsartan 80mg, Iron supplement, VitD",none,Htn,,none,"['Erythema', 'Swelling']",1,MODERNA,IM 918296,OH,44.0,F,"Moderna COVID-19 Vaccine Vaccine on day 0 GI symptoms on days 1, 2, 3, and 4 including abdominal cramps, constipation, gas Uterine cramps (not related to menstruation) and light spotting on day 2 Soreness at injection site days 0, 1, 2, and 3",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,WRK,"OTC vitamins: iron, B6, folate, B12, D",None,None,,NKA,"['Abdominal pain', 'Constipation', 'Flatulence', 'Injection site pain', 'Metrorrhagia', 'Uterine spasm']",1,MODERNA,IM 918297,VT,32.0,M,arm pain,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/18/2020,0.0,PVT,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH,IM 918298,MO,36.0,F,"Injection received at 0815. At 0900 I started getting diaphoretic, clammy, nauseas and my face was flushed. At 0930, I developed hives on my neck, chest and arms. I immediately went back to the vaccination site (I was still in the hospital at work) and was administered 25mg oral Benadryl and monitored for 30 minutes. The hives resolved, but I still felt unwell. At 1600 I noticed a swelling in my right upper thigh about the size of my hand. It was about 2 inches inferior to my inguinal crease and was the width of my thigh. It was mildly painful to the touch. My injection site was red, inflamed and itchy. I continued taking 25-50mg Benadryl Q4 and took 100 mg at night due to itchiness on my eyes, face, neck, chest and arms. This is still present, although less each day, as of Monday 1/4/21 morning. I have felt feverish but have not had a recorded fever. I took some Ibuprofen for the pain in my arm at the injection site. The redness, swelling and itchiness has decreased each day at the injection site, but is also still present as of Monday 1/4/21 morning. I still feel unwell and have continued diarrhea throughout the weekend.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"1 Fluoxetine 20mg, 1 vitamin B12 1000mcg, 1 Drospirenone and Ethinyl Estradoil Tablets USP 3mg/0.03mg (oral birth control), 2 Goli Apple Cider gummies, 2 sambucus elderberry gummies, 2 magnesium 200 mg tablets, 1 MICRO Factor Pack (https:/",None,None,,"Oral sulfa medications (hives). I do not have any known allergies to foods, just food intolerances.","['Cold sweat', 'Diarrhoea', 'Flushing', 'Hyperhidrosis', 'Injection site erythema', 'Injection site inflammation', 'Injection site pain', 'Injection site pruritus', 'Malaise', 'Nausea', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Pyrexia', 'Urticaria']",1,PFIZER\BIONTECH,IM 918299,MA,58.0,F,"The day of the vaccine I had a initial diarrhea and headache, minimum pain on the site of the injection but at 2AM on the 22nd I woke up from my sleep with chills, and shaking even my teeth were clacking. Took Tylenol and it got better around 30 min later. Felt very fatigued and still nauseated almost threw up. By the end pf the day it resolved itself.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/22/2020,4.0,PVT,"Labutren, omeprazole, hydrocholoritizide, lisinopril",No,Hypertension,,No,"['Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'SARS-CoV-2 test negative', 'Tremor']",1,PFIZER\BIONTECH,IM 918300,ID,46.0,F,"patient developed headache, nausea and abdominal pain day of vaccination that continued for two days post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Abdominal pain', 'Headache', 'Nausea']",1,MODERNA,IM 918302,AZ,60.0,F,"Flu-like symptoms - nausea, sweat. Arm sore immediately after injection - sore for 2 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,"Tecfidera, Ampyra, Baby Aspirin, Vitamin D, Biotin, Losartin, Baclofen, Lyrica",None,M.S.,,"Ampicillin, Amoxicillin","['Hyperhidrosis', 'Immediate post-injection reaction', 'Influenza like illness', 'Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 918303,NC,58.0,F,"12/17/2020 VACCINE 12/18/2020 SWOLLEN LYMPHNODES IN GROIN, FATIGUE 12/21/2020 EXPERIENCED A STEMI; RUSHED TO ER; FELT LIKE COULDN'T BREATHE, INCREASED HR CARDIAC CATH",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/21/2020,4.0,MIL,"CRESTOR DAILY, BP MEDICINE (UNKNOWN) DAILY, FISH OIL, BABY ASPIRIN DAILY",,"HYPERTENSION (CONTROLLED WITH MEDICINE), HIGH CHOLESTEROL (CONTROLLED WITH MEDICINE), ASTHMA",,"REGLIM CHOMPAZINE, PHENEGREN","['Acute myocardial infarction', 'Catheterisation cardiac', 'Dyspnoea', 'Electrocardiogram', 'Fatigue', 'Heart rate increased', 'Lymphadenopathy']",1,PFIZER\BIONTECH,SYR 918304,MA,51.0,F,"Employee states reaction to every vaccine she receives. Employee states ticks, perseveration, uncontrolled laughing and crying which resolve on own. This happened today immediately after vaccine administered. Employee given water, cold pack. Symptoms resolving on own as stated. Will keep longer for observation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,,,,"Employee states reaction to every vaccine she receives. Employee states ticks, perseveration, uncontrolled laughing and crying w",,"['Crying', 'Immediate post-injection reaction', 'Inappropriate affect', 'Tic']",1,MODERNA,IM 918305,ID,46.0,F,"patient developed headache, nausea and abdominal pain day of vaccination that lasted two days following administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Abdominal pain', 'Headache', 'Nausea']",1,MODERNA,IM 918306,KY,63.0,F,"EE received Covid-19 Moderna vaccine on 12/29/20 at 5:10 p.m. at Covid vaccination site. 12/30/20 at 3:00 a.m.EE had pain in left side, hip and leg waking EE up from sleep . Lesions times two, one on hip and one on posterior upper leg. MD insructed EE to double Vitamin C orally and to place Bacitracin on the two lesions, which at first appeared to contain bloody drainage. Lesions are now dry. VAERS document completed.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,UNK,"Vitamin C, Vitamin D, Lipitor, Singulair",denied,Hyperlipidemia,,"Iodine, Penicillins, Salicylates","['Arthralgia', 'Flank pain', 'Haemorrhage', 'Pain in extremity', 'Skin lesion', 'Sleep disorder']",1,MODERNA,IM 918307,FL,56.0,M,"fever 100.6, chills, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,PVT,"Vitamin D, zinc, vitamin C",no,none,,none,"['Chills', 'Headache', 'Pyrexia', 'SARS-CoV-2 test', 'Viral test']",1,PFIZER\BIONTECH,IM 918308,ID,51.0,M,"patient developed flu like symptoms such as body aches, chills, fever, as well as arm pain day after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Chills', 'Influenza like illness', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 918309,NJ,56.0,F,Extreme left arm pain. Site is redden and warm to touch. Low grade fever. Head ache. Loss of appetite I had a hard time sleeping. I just took Tylenol.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,PVT,None,None,Poor eye sight,,None,"['Decreased appetite', 'Headache', 'Injection site erythema', 'Injection site warmth', 'Insomnia', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 918310,,54.0,F,"12/30/2020 - Pt c/o low-grade fever about 20 hrs after vaccine dose given. 3 hrs later, c/o temp. 101.6 F. 12/31/2020 - Pt c/o fever, dry cough, fatigue, nausea, light H/A. Referred her to PMD.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,PUB,"OTC-Estrovan, Zyrtec, Vitamin D3-2,000 mg., Vitamin C.",,arthritis,,NKA,"['Cough', 'Fatigue', 'Headache', 'Influenza virus test negative', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 918311,ME,40.0,F,"Hives, itching, nausea, vomiting, very mild respiratory wheezing.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,"Benadryl, singulair, zyrtec",None,Asthma and allergies,H1N1 delayed,"Hazelnuts, H1N1 vaccine reaction, Zithromax, Advair discus. Possibly Vicodin and Ultram Cattle protein sensitivity","['Nausea', 'Pruritus', 'Urticaria', 'Vomiting', 'Wheezing']",1,MODERNA,IM 918312,AL,68.0,M,"After receiving the vaccine, no problems until I woke up in the middle of the night, and I was sore and my arm was hurting and I was sweating. I started having chills. I have a fever, still with aches and pains. The soreness at the injection site is about gone. Yesterday, 01.03.21, I was running a fever between 99-101 all night long. Last night I took one Tylenol to help slow it down a little. It's been pretty severe up until now. Right now my temp is 98.1. I did not go to the ER and my wife has the lot number in her purse with her right now.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PUB,"One a Day Multivitamin, Fexofenadine, Benazepril-htcz 20mg , Pravastatin 80 mg, Baby Asprin once a day",No,High Blood Pressure and High Cholesterol,,No,"['Chills', 'Hyperhidrosis', 'Injection site pain', 'Pain', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA, 918313,MA,42.0,F,Brief dizziness lasting 2 seconds.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,,,,,,['Dizziness'],1,MODERNA,IM 918314,TN,58.0,M,"Had dull ache and knot in arm since getting vaccine. On day 8 he developed chills, body aches, hot and swollen arm, itchy, as well as fatigue, weakness, sneezing, coughing, congestion.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,WRK,,,narcolepsy,,bee pollen,"['Asthenia', 'Chills', 'Cough', 'Fatigue', 'Injection site mass', 'Nasal congestion', 'Pain', 'Peripheral swelling', 'Pruritus', 'Sneezing']",1,MODERNA,IM 918315,ID,42.0,F,patient developed nausea and arm soreness at injection site day after administration. Symptoms lasted about 1 day. No other complaints.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Injection site pain', 'Nausea']",1,MODERNA,IM 918316,TX,54.0,F,"Dec 31 Itching began on lower legs/ankle, then on Jan 4 swelling, redness, itchiness at injection site; headache began 3rd and 4th.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/31/2020,5.0,PVT,"Lexapro 10mg, Vit D, Vit C",none,,,Lobster,"['Headache', 'Injection site erythema', 'Injection site pruritus', 'Pruritus']",1,MODERNA,IM 918317,OH,46.0,F,"had slight soreness and redness at site of injection after vaccine was administered, but one week later it flared up with discomfort, redness, swelling, larger than diameter of softball. the site was hot to touch. it has improved but upper L arm is still red with slight ache. informed Employee health of problem.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/01/2021,8.0,PVT,tylenol,none,none,,none,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 918318,FL,42.0,F,Pain at injection site R shoulder pain and very limited range of motion Fatigue Chills Temp 100.5,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,Pristiq Vitamin D 3 Turmeric Oxybutynin Zyrtec CBD oil Nasonex,None,,,Flagyl Inapsine,"['Arthralgia', 'Body temperature increased', 'Chills', 'Fatigue', 'Injection site pain', 'Joint range of motion decreased']",UNK,MODERNA,IM 918319,ID,33.0,F,patient developed arm soreness at injection site day after vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,,,,,,['Injection site pain'],1,MODERNA,IM 918320,,29.0,F,Elevated heart rate within the first five minutes after injection. Went away in about one minute. Came back for about one minute in five minute intervals for a duration of about 40 minutes after injection. Feeling flushed with the first 15 minutes after injection. Soreness at injection site 24-48 hours after injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,PVT,,,,,,"['Heart rate increased', 'Hot flush', 'Injection site pain']",1,PFIZER\BIONTECH,IM 918321,CT,30.0,F,"Large asymmetrical rash on enter outer side of bicep. Very red on edges, less red in the middle. Initially smaller and more red, gradually becoming very itchy and spreading while the center is less red than before. Unsure if headaches and fatigue are related.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/02/2021,11.0,PVT,"Dexilant 60mg, Desvenlafaxine 125mg, OTC Claritin 10mg, OTC Magnesium Glycinate 200mg, OTC Align Probiotic Prebiotic",,"IBS, migraines, depression, anxiety",,"Sulfa drugs, Amoxicillian, Minocycline","['Fatigue', 'Headache', 'Rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 918322,NY,58.0,F,"Fifteen minutes post Moderna COVID vaccine patient felt her lower lip get heavy, and itchy, similar to when she had an allergic reaction to other medications. It resolved spontaneously after 23 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Januvia 100 mg, Amaryl 1 mg, Lisinopril 20 mg",,"diabetes, hypertension, high cholesterol",,"Metformin, Cephalosporins, Aspirin, Naproxen, strawberries, grapes, apples, pollen",['Lip pruritus'],1,MODERNA,IM 918323,PA,54.0,F,"Received first dose of Pfizer vaccine on December 28th in left upper arm. On the afternoon of December 30th a rash was identified on my torso. It was not very itchy, took few doses of Benadryl and was resolved next day. May I receive the second dose scheduled in few weeks?",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,PVT,VITAMINS,NONE,NONE,,AMOXICILLIN,['Rash'],1,PFIZER\BIONTECH,IM 918324,VT,39.0,F,arm pain,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/18/2020,0.0,PVT,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH,IM 918325,KY,24.0,F,Moderna COVID-19 Vaccine Approximately 24 hours following the vaccination I began to feel light headed and extremely fatigued. I began to have a small rash around my hair-line that spread to my chest and arms. I self-medicated with diphenhydramine and recovered by the end of the day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,Birth control,None,None,,Shellfish,"['Dizziness', 'Fatigue', 'Rash']",1,MODERNA,SYR 918326,VA,38.0,F,"Bruising throughout body. Between toes, legs, and arms",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PUB,"Lexapro- 10 mg everyday , Biotin",none,anxiety,,Phenergan,['Contusion'],2,MODERNA,IM 918327,MT,90.0,F,red warm to touch area at insertion site with pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,SEN,,,Alz Dementia,,"Biaxin, Betamethasone,Triamicinolone","['Injection site erythema', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 918328,MA,54.0,F,"Felt woozy/dizzy, the head ache started , then nausea without vomiting. BP 180/84, BP 170/82 Supervisor was called and let her know that patient would not be able to work today. Patient stayed for 2 hours and symptoms subsided. EMS checked her out. She then drove home.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,WRK,"Clonidine patch (for BP), Prednisone (2 days only), Ambien, Vitamins",,,,"Lisinopril, Amlodipine, Sulfa, E-mycin","['Blood pressure increased', 'Dizziness', 'Headache', 'Nausea']",1,MODERNA,IM 918329,MD,67.0,F,"Severe left arm pain, stiffness. Left shoulder pain. Neck pain. Stated she couldn't lift her left arm for three days after the vaccine. Low grade fever. Reported feeling disoriented, sweating, no appetite for a couple days. Fever has resolved, but other symptoms still remain. Advised employee to call doctor to report symptoms and get advise regarding next vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,WRK,,,,,,"['Arthralgia', 'Decreased appetite', 'Disorientation', 'Hyperhidrosis', 'Injected limb mobility decreased', 'Musculoskeletal stiffness', 'Neck pain', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA,IM 918330,WI,32.0,F,"5 minutes post injection employee experienced warmth, redness, itching to injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Omeprazole, Multivitamin, Topamax","Covid-19 around December 10, 2020.","Anxiety, Migraines",,"Amoxicillin-reaction is Hives, Penicillin reaction is Hives, Nickel reaction is rash/blister","['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 918332,VT,42.0,F,arm numbness,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/18/2020,0.0,PVT,,,,,,['Hypoaesthesia'],1,PFIZER\BIONTECH,IM 918333,AZ,44.0,F,"""extreme vomiting"", patient left prior to being seen by physician",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/03/2021,1.0,PVT,"buproprion, escitalopram, gabapentin, hydrcortisone, levothyroxine, lidocaine patch, melatonin, zofran, senna, buproprion, fioricet, clonazepam",,,,sulfa,['Vomiting'],1,PFIZER\BIONTECH,IM 918334,NC,60.0,F,"After about 24 hours: muscle and joint pain; After about 48 hours: intense muscle and joint pain back pain, fever of 101.7, shortness of breath Following day: weakness, extreme fatigue, tachypnea, shortness of breath on exertion Shortness of breath and cough persisted for several days, finally resolved day 6 post vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,PUB,"Pantoprazole, WellbutrinXL, Lisinopril, Amlodipine, Famotidine, Trazodone, Reclast, Vitmin D, Calcium, berberine, multivitamin",none,"hypertension, osteoporosis, Barrett's esophagus, depression/anxiety, mild asthma","high fever following flu vaccination in Sept, 2020","Sulfa, HCTZ, Metaclopramide, Macrobid","['Arthralgia', 'Asthenia', 'Back pain', 'Cough', 'Dyspnoea', 'Dyspnoea exertional', 'Fatigue', 'Myalgia', 'Pyrexia', 'Tachypnoea']",1,MODERNA,IM 918335,OH,43.0,M,3-in circumferral rash around injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/03/2021,8.0,UNK,,,Childhood asthma. I do not currently take any medications for asthma as I do not have any issues with asthma.,,"Amoxicillin, sulfa",['Injection site rash'],1,MODERNA,IM 918337,NY,39.0,F,"Mild redness, swelling for 3 days after injection noted by patient. One week after the injection, patient reported developing a ""golf ball sized lump"" and redness that lasted an additional three days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,PVT,,,,,,"['Erythema', 'Mass', 'Swelling']",1,MODERNA,IM 918338,MI,64.0,F,"about 4 hours after vaccine, patient passed out and when came to, vomited profusely. Transferred to hospital ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,none,"thyroid disease, gerd",,"statin, hydrocodone/acetaminophen, morphine","['Blood potassium decreased', 'Loss of consciousness', 'Vomiting']",1,MODERNA,IM 918339,ME,55.0,F,"itchy throat then gave benadryl 50mg and famotidine 20mg at 10:09 , Itchy throat persisted and sent patient to ER. On arrival to ER throat and tongue started to swell. ER administered EPIpen and steroids and monitored 2 hours post treatment. Patient had to additional benadryl and pepcid the next evening due to coughing. Patient started oral steroids on 01/02/2020 in the morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,,,,Flu once before prior to preservative free,"nuts, soy, wheat,","['Cough', 'Pharyngeal swelling', 'Swollen tongue', 'Throat irritation']",1,MODERNA,IM 918340,IA,35.0,F,"8 days after the injection I acutely developed itching, redness, and induration of the injection site. Lasted 24 hours, spread slightly and then started to resolve.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/03/2021,8.0,WRK,Topamax,No,Migraines,,No,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus']",1,MODERNA,IM 918341,WI,25.0,F,Developed rash on left side of neck one day following vaccination. Vaccine given in Rt deltoid,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,WRK,,,asthma,,,['Rash'],UNK,MODERNA, 918342,MD,28.0,M,Woke up to a burning sensation all over my face that quickly spread to my upper torso. I stumbled into the bathroom and removed my pajama shirt to relieve the heat I was experiencing. I ran my hands under luke warm water and the sensation suddenly disappeared as quickly as it came. Later that same day I experienced fatigue and loss of appetite that lasted about 24 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PHM,Daily Multivitamin,None,None,,Intolerance to lactose,"['Burning sensation', 'Decreased appetite', 'Fatigue', 'Gait disturbance']",1,PFIZER\BIONTECH,IM 918343,MO,62.0,F,"Employee relates at 1:30 AM on Sat., 1-2-21, symptom onset began...fever of 102.8 oral, ""raging"" HA, cough, chilling/shaking that lasted for 3 hours. Note: employee did test COVID positive on Nov. 9, 2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/02/2021,2.0,PVT,,,,,,"['Chills', 'Cough', 'Headache', 'Pyrexia']",1,MODERNA,IM 918344,WA,37.0,F,Headache and nausea with in hour of vaccine. Vomiting 6 hours after vaccine with extreme dizziness like on a boat.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PHM,"Lisinopril-hctz 20/25mg bid, niphedipine 60mg daily",None with myself 2 positive COVID19 children in my house at the time of vaccine,High blood pressure,,"Crestor, percocet, ultram/tramadol","['Cough', 'Dizziness', 'Headache', 'Nausea', 'Oropharyngeal pain', 'Pain', 'SARS-CoV-2 test', 'Sinus operation', 'Vomiting']",1,MODERNA,IM 918345,FL,36.0,F,December 28 developed large red edematous area around injection site. Hot to touch. The area continues at this time despite taking Benadryl and Pepcid every 12 hours as advised by PCP,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/28/2020,6.0,PVT,Wellbutrin 150mg daily,None,"Depression/anxiety, headaches",,Latex,"['Injection site erythema', 'Injection site oedema', 'Injection site warmth']",1,MODERNA,IM 918347,TN,40.0,F,"FEVER ACHE, CHILLS, Lethargy",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,,,,,,"['Chills', 'Lethargy', 'Pain', 'Pyrexia']",1,MODERNA,IM 918348,PA,60.0,F,"* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, cold and unable to get warm even with multiple blankets * Severe dizziness and vomiting * Headache not relieved by Ibuprofen; took 25 mg Benadryl at midnight",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,SEN,* Ibuprofen * Multi-Vitamins,None; corneal abrasion,,,"Latex, PCN, Nuts, Avocado","['Chills', 'Dizziness', 'Feeling cold', 'Headache', 'Injection site pain', 'Vomiting']",1,PFIZER\BIONTECH,IM 918349,CT,49.0,F,"Patient felt lightheaded, dizzy, diaphoretic and c/o feeling faint at time of injection. She has a history of anxiety and feels it may that. Repeat BP 149/85 HR 98 POC glucose 98. Patient monitored for 50 minutes after episode began. Patient stated she felt much better and felt comfortable and wanted to leave. Patient escorted out by RN to car. Patient walked out of building with assistance and reported she felt good with the cold air. EMS offered patient to go to ED but patient declined",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,Naratriptan,,"Migraines, SVT",,"Sulfa, Celexa, Oxycodone","['Blood glucose normal', 'Dizziness', 'Hyperhidrosis']",1,MODERNA,IM 918350,VT,39.0,M,"nausea, elevated pulse, anxious; declined Emergency department evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/18/2020,0.0,PVT,,,,,,"['Anxiety', 'Heart rate increased', 'Nausea']",1,PFIZER\BIONTECH,IM 918351,OK,41.0,F,"12/19/2020-12/20/2020 only experiences soreness of left arm where vaccine received. Woke up early morning 12/21/2020 with moderate swelling of eyelids, face, lips that progressed over several hours before seeking care at Hospital ED. Received IV Benadryl and IV solumedrol. Prescribed oral prednisone dose pack to start next day. Symptoms mostly resolved by that evening.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/21/2020,3.0,PVT,"vitamin c daily, black elderberry supplement daily, aloe vera supplement daily, phentermine daily, pantoprozole 40mg daily",None,GERD,Abnormal Swelling and redness of upper arm when receiving influenza vaccines for several years.,,"['Lip swelling', 'Pain in extremity', 'Renal function test', 'Swelling face', 'Swelling of eyelid']",1,PFIZER\BIONTECH,IM 918352,WV,55.0,F,Headache for about 3 hours. Tylenol then fine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,Lexapro Ropinirole multi vitamin probiotic simvastatin,none,RLS cholesterol,,wellbutrin,['Headache'],1,MODERNA,IM 918353,OH,41.0,F,"Sensation in teeth. Jaw then dizzyness. Headache. Took tylenol at work..then went home and took benadryl. Sensitivity to spoons, metal. Today 1/04 itching and lump at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PUB,Tylenol. After for headache. Felt sensation in teeth and jaw right after. Dizzyness.. took benadryl when home.,No,No,,"Pcn, acetaminophen sulfa, tetracycline amoxicillin. (Body rash)","['Dizziness', 'Headache', 'Hyperaesthesia teeth', 'Injection site mass', 'Injection site pruritus', 'Jaw disorder']",UNK,MODERNA,ID 918359,MD,48.0,F,"Initially had arm pain in the left deltoid area with mild induration, chills and some bodyaches. Generalized fatigue. Two days ago(1/2/21) a large left supraclavicular lymph node came up, it is a little sore. No redness. Moveable. No coughing or SOB. No difficulty swallowing. No rash to that area. No sore throat or other known cause at this time for the adenopathy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Chills', 'Fatigue', 'Injection site induration', 'Injection site pain', 'Lymph node pain', 'Lymphadenopathy', 'Pain']",1,PFIZER\BIONTECH,IM 918360,SC,45.0,F,"severe cough with chest heaviness and mucous production, fatigue,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/26/2020,3.0,PVT,"Vitamin C, biotin, elderberry, zinc, vitamin D",Had + COVID-19 test on 11/29/20,none,,PCN,"['Chest discomfort', 'Cough', 'Diarrhoea', 'Fatigue']",1,MODERNA,SYR 918361,TX,58.0,F,"A few hours after vaccination, I began to feel like I was getting ill, with fatigue and headache. I also experienced swelling at site of injection, along with hives on my face and neck on the same side as the injection. I had swelling in my neck, throat, tongue, lips, ears and eyes with some tingling. There was a red pallor on both of my cheeks. I also had slightly labored breathing. I took antihistamines and tylenol which helped reduce the symptoms within an hour. If I did not continue to take these round the clock for the next 4 days, the symptoms would get worse. Toward the end of the day, symptoms worsened regardless of antihistamine or tylenol and continue to do so as of yesterday, 1/3/2021. Symptoms have gotten better over the last 4 days. Its hard to say if I am fully recovered as in the evenings when I'm more fatigued, I still have the tingling and mild swelling although the redness and hives have abated.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PHM,,,,"I don't know brand names or dates but I have reacted to most of the vaccines I've been given, MMR, small pox, etc","Reglan, Penicillin, Sulfa","['Dyspnoea', 'Ear swelling', 'Erythema', 'Eye swelling', 'Fatigue', 'Headache', 'Injection site swelling', 'Lip swelling', 'Malaise', 'Pallor', 'Paraesthesia', 'Pharyngeal swelling', 'Swelling', 'Swollen tongue', 'Urticaria']",1,MODERNA,IM 918362,WV,60.0,M,"Patient c/o aches and pains all over and weakness, Tylenol given.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/27/2020,4.0,OTH,"Naproxen 500 mg, 1 tab twice a day for pain, Omeprazole 20 mg take one cap po for stomach, Olanzapine 10 mg take one tab po daily, Cholecalcif 50 mcg d3-2000 units, take 2 tabs po daily for vit replacement.",See list below,"Diverticulitis, hyperlipidemia, nicotine dependence, chronic sinusitis, dizziness and giddiness, homicidal ideations, enlarged lymph nodes, jaw pain, pulmonary nodule, acute bronchitis, corns and callosities.",,NKA,"['Asthenia', 'Pain']",1,MODERNA,IM 918363,IL,65.0,M,"Rash on bilateral arms, abdomen, stomach, legs with itching",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/20/2020,1.0,PVT,BPH medication: silodosin,,,,none,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 918364,MT,45.0,F,Developed blisters and sores outside of the vagina. Not sure if it triggered the HPV I had as a teenager.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,Trazadone Cyclobenzaprine HCL,,Liver problems,,Penicillin,['Genital blister'],1,MODERNA,IM 918366,VT,56.0,F,arm tingling,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,,,,,,['Paraesthesia'],1,MODERNA,IM 918367,MA,37.0,F,"Call to EE 12/22 regarding facial numbness/ tingling after vaccine. Notes she received vaccine 12/18. Was fine for first 15 minutes. Within 5-10 minutes of leaving, ee had facial numbness to right side of face and under bottom lip. Sx lasted about 3 hours and resolved 100%. No recurrence.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,WRK,,,,,,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 918368,,30.0,M,"lightheaded, drank water and laid down for several minutes - symptoms resolved and patient left without further issues",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/21/2020,0.0,UNK,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 918370,SC,24.0,M,"7pm 01/02/2021- Right hand became itchy: urticaria appeared across right hand, left wrist, elbow creases, right foot. 1pm 01/03/2021- went for a run while wearing a sterling silver necklace (which has been worn almost every day for past year) began to feel a burning sensation. Took off necklace and had urticaria all around neck where necklace had been. (took ice baths, used lotion, and took 2 tablets of hydroxyzine which all alleviated itchiness and most of the redness/bumps had disappeared when waking up on 01/04/2021).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/02/2021,3.0,PVT,Vybriid; Truvada; Hydroxyzine Hcl; Magnesium; Vitamin C; Prilosec,None,GERD; Depression,,None,"['Burning sensation', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 918371,WI,38.0,F,"Developed small rash on neck, side that vaccination was administered. Last one hour, no other symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,,,,,,['Rash'],UNK,MODERNA, 918372,VT,59.0,U,left arm injection with hand tingling,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Injection site paraesthesia', 'Paraesthesia']",1,MODERNA,IM 918373,VT,22.0,F,shortness of breath developed 10 minutes after receiving vaccine. No other syptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,,,,,,['Dyspnoea'],1,MODERNA,IM 918374,,55.0,F,"itching that started @injection site and then spread across body, facial flushing Administered 50 mg of diphenhydramine orally and continued to observe Patient's husband was called and he took her home after approximately 30 mins.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/21/2020,0.0,UNK,,,,,,"['Flushing', 'Injection site pruritus', 'Pruritus']",1,PFIZER\BIONTECH,IM 918375,MA,50.0,F,Patient stated she felt she had tachycardia- pulse was 130's for approximately 2 minutes - resolved spontaneously. Patient asked for assistance due to history of SVT's,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,Zoloft,,History of SVT's- ablation 8 years ago,,Bees,['Tachycardia'],1,MODERNA,IM 918377,,60.0,F,Received covid 19 first dose on 12-23-20 and on 01-01-21 insertion site became red and itching. On 01-04-21 the redness measures 4cm x 8cm.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,01/01/2021,9.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 918378,CA,49.0,F,"12/31/20 7:00PM -7:30 PM chills, abd pain, exhaustion - fatigue; 01/01/21 Next morning severe headache, Motrin 800Mg - fatigue, headache resolved with Motrin, without appetite, sleep all day and night; abd pain resolved. 01/02/21 fatigue, first meal since 12/31/20. 01/03/20 feeling better,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Cymbalta, Tumeric, Vitamin D",,RSD,,Codeine,"['Abdominal pain', 'Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Hypersomnia', 'SARS-CoV-2 test negative']",1,MODERNA, 918379,MI,80.0,F,"Rash on both legs, Made her feel faint. Vomiting. Diarhea. Back hurts in the middle. Loss of taste.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,"Atenolol, Aspirin 81mg, Vitamin D,",None,"HTN,",,None,"['Ageusia', 'Back pain', 'Diarrhoea', 'Dizziness', 'Rash', 'Vomiting']",1,MODERNA,IM 918380,WI,25.0,F,"Became nauseous, pale, faint after first dose .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Unknown,No,No,,No,"['Dizziness', 'Nausea', 'Pallor']",1,PFIZER\BIONTECH,IM 918381,SD,33.0,F,"Fever, body aches, joint paint, headache, all over muscle pain/aches, chills, shaking, nausea, vomiting, diarrhea, and a rash on my neck. Symptoms started 36 hours after vaccine was administered. The rash on my neck started 4 days after the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,WRK,Spironolactone 50mg BID Zyrtec 10mg Daily Nexium 20mg Daily,,,,CT IV Dye,"['Arthralgia', 'Chills', 'Diarrhoea', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Rash', 'SARS-CoV-2 test negative', 'Tremor', 'Vomiting']",1,MODERNA,IM 918382,VT,62.0,F,left arm numbness,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,,,,,,['Hypoaesthesia'],1,MODERNA,IM 918383,VA,35.0,F,"Got a really bad headache starting around 5:00 pm on 12/29/20 , Headache remained for about 3 days. 12/30/20 around 11:00 am starting to get severe low back pain radiating to the upper back , breathing taking pain this lasted into the night of 12/31/20. extreme fatigue still currently 1/4/2021 , Agitation and mental offset ( Angry) and emotional for 5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,No,Sinus infection was prednisone,"Hypothyroidism, High Cholesterol , Anxiety , Migraines , fatty liver",,"Penicillin, Keflex ,Percoset","['Agitation', 'Anger', 'Back pain', 'Emotional distress', 'Fatigue', 'Headache', 'Mental disorder', 'Painful respiration']",1,MODERNA,SYR 918384,ME,37.0,F,"patient started filling flush and warm about 20 mins after vaccination. in standing position felt slightly dizzy and nausea, Laid down felt better but still hot. no medication given. HR was 70 Stats 98. Patient laid down for one hour when she felt better. next two days patient had redness and warmth at site of injection about the size of a quarter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/25/2020,12/25/2020,0.0,PVT,,,,,Bee-sting,"['Dizziness postural', 'Feeling hot', 'Flushing', 'Injection site erythema', 'Injection site warmth', 'Nausea']",1,MODERNA,IM 918385,MN,46.0,F,"reported next day waking up and extreme fatigue, chills, fever, local swelling and pain. continued for 12 hours with alternating Tylenol and ibruprophen for pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PUB,no,had appendix removed one month prior,no,,no,"['Chills', 'Fatigue', 'Pain', 'Pyrexia', 'Swelling']",1,MODERNA,IM 918386,MA,62.0,F,"Patient left building and started to walk to car and turned around with c/o ""lump in throat. She c/o tightening in throat and hard to swallow. She was taken to EMS, 50 mg IM was given and symptoms subsided in about one hour with her going home with husband 90 minutes after start of symptoms. O2 sat 100% , BP at start was 170/80, hr-100, and at departure was 120/78, HR-80.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"Pepcid, Vitamins",,None,,NKA,"['Dysphagia', 'Sensation of foreign body', 'Throat tightness']",1,MODERNA,IM 918387,NJ,63.0,M,"True vertigo - room spinning dizziness, perceived motion, made worse with changes in head position. Nausea and vomiting at extremes of vertiginous symptoms. Also generalized fatigue noted. No fever, chills, diaeresis, headache, hearing loss, loss of taste or smell, cough, or nasal congestion, muscle aches, body aches or myalgias.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/28/2020,4.0,PVT,none,none,none,,none,"['Fatigue', 'Nausea', 'SARS-CoV-2 test negative', 'Vertigo', 'Vomiting']",1,MODERNA,IM 918388,FL,65.0,F,"Resident found unresponsive without pulse, respirations at 04:30 CPR performed, expired at 04:52 by Rescue",Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,SEN,Albuteral Sulfate Amlodipine Carvedilol Ipratropium Levetiracetam Olanzapine Sodium Chloride Symbicort Valproic Acid,No acute illness at time of vaccination. History of: CVA SCPT Dementia Seizure Disorder HTN COPD,As noted above,,NKA,"['Death', 'Pulse absent', 'Respiratory arrest', 'Resuscitation', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 918390,VT,18.0,F,"tightness in throat, had initial itching in arm",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Pruritus', 'Throat tightness']",1,MODERNA,IM 918391,,40.0,F,"Developed pain at injection site, itching of B/L hands and feet, diffuse non-pruritic rash over extremities / torso within several hours of injection. Developed fever to 103 night of vaccination. No further symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,UNK,Multiple environmental allergies,,,,,"['Injection site pain', 'Pruritus', 'Pyrexia', 'Rash']",UNK,MODERNA, 918392,MA,58.0,F,"""Moderna COVID-19 Vaccine EUA"": Developed chills during the night after receiving Moderna COVID 19 Vaccine. 12/31/20, 4:45am - Chills, shaking, weakness, dizziness, and fever. Checked temp 6:00 am - 101.2. Took Tylenol 1000 mg every 8 hours starting at 6:15am. Fever all day until the following morning. 1/1/21- Severe body aches - 1/2/21.. Symptoms improved except fatigue. Symptoms better 1/3/21.,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,"Atenolol 50 mg daily, Lisinopril 10 mg daily, Hctz 25 mg daily, Gabapentin 300 mg BID, Primidone 250 mg, BID, Calcium 600 mg daily",none current. Tested Positive for COVID 19 on 11/09/2020,"HTN, Benign Essential tremor, Right leg nerve damage and pain",,"PCN, Percocet","['Asthenia', 'Chills', 'Dizziness', 'Pain', 'Pyrexia', 'Tremor']",1,MODERNA,IM 918393,MA,62.0,F,"Patient left building and started to walk to car and turned around with c/o ""lump in throat"". She c/o tightening in throat and hard to swallow. She was taken to EMS, 50 mg IM was given and symptoms subsided in about one hour with her going home with husband 90 minutes after start of symptoms. O2 sat 100% , BP at start was 170/80, hr-100, and at departure was 120/78, HR-80",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"Pepcid, Vitamins",,None,,NKA,"['Dysphagia', 'Sensation of foreign body', 'Throat tightness']",1,MODERNA,IM 918394,TX,33.0,F,fast heart rate after about 20 minutes of the vaccine that lasted an hour; dizziness or feeling of overwhelming for about an hour as well; was able to drive home no problem; very very tired after vaccine; no treatment everything was self-limiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,"Centrum MVI, Caltrate D, Turmeric, Vit D, Vit C, Fish Oil",,,,,"['Anxiety', 'Dizziness', 'Fatigue', 'Heart rate increased']",1,MODERNA,IM 918395,,38.0,F,9 x 9.5 cm redness and felt harder and warmer than surrounding area appear 48 hours after being vaccinated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/27/2020,12/30/2020,3.0,PVT,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site warmth']",1,MODERNA,IM 918397,,39.0,M,8 days after vaccination I came down with a cold. Started with a sore throat then progressed to stuffy and runny nose and a dry cough,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,01/01/2021,8.0,WRK,,,,,,"['Cough', 'Nasal congestion', 'Nasopharyngitis', 'Oropharyngeal pain', 'Rhinorrhoea']",1,MODERNA,IM 918399,MI,41.0,F,"Fever, Headache, Nausea, stomach cramping, vivid dreams",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/01/2021,4.0,PVT,,None,BRCA2 positive,,,"['Abdominal pain upper', 'Abnormal dreams', 'Headache', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH, 918400,IN,35.0,F,"Moderna COVID-19 Vaccine Swelling at injection site, red and raised with aching pain through the left shoulder and neck",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/01/2021,8.0,PVT,"Progestin only birth control, prenatal vitamin",None,None,,None,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Neck pain']",1,MODERNA,SYR 918401,NE,34.0,F,"DEVELOPED FATIGUE, CHILLS, FEELING OF SOMETHING HEAVY ON CHEST, CONFUSION",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/01/2021,10.0,SEN,,,,,,"['Chest discomfort', 'Chills', 'Confusional state', 'Fatigue']",1,PFIZER\BIONTECH,IM 918402,,55.0,F,"headache, myalgia, fatigue, chills, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,UNK,,,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 918403,MA,53.0,F,Pt reported feeling fuzzy/dizzy and lightheaded. Sat and rested with water and VS check and returned to baseline 40 minutes later. Pt felt ok to drive after her evaluation from EMT's and left to go to work.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"Metoprolol 50mg once daily, Atorvastatin 40mg daily, Famotidine 40mg nightly, Gabapentin 300mg AM and 100mg PM",,"Hypertension, High cholesterol, Arthritis",,Sulfa with symptoms of itchy throat,"['Dizziness', 'Hypertension']",1,MODERNA,IM 918404,NJ,63.0,M,"True vertigo. Room spinning dizziness with perceived movement. Symptoms made worse by changes in head position. Nausea and vomiting with extremes of vertigo symptoms. NO fever, chills, cough, loss of taste or smell. No muscle aches, body aches, myalgias, nasal or sinus congestion.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/28/2020,4.0,PVT,none,none,none,,none,"['Dizziness', 'Nausea', 'SARS-CoV-2 test negative', 'Vertigo', 'Vomiting']",1,MODERNA,IM 918406,IL,63.0,F,Tightness on the chest Blood Pressure was high 185 or 198 Dry Mouth Hard time to breath After 1 hour I started itching,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,Levimier Ozempic 45 microgram Jaidince 25mg Lisinopril high 10mh/12.5mg daily Simvastatin 10mg Syndrio 250mg Baby Aspirin 81mg feinberg 54mg,,Diabetic High Blood Pressure High Cholesterol high hypometabolism,,,"['Chest discomfort', 'Dry mouth', 'Dyspnoea', 'Electrocardiogram normal', 'Hypertension', 'Laboratory test normal', 'Pruritus']",UNK,PFIZER\BIONTECH,IM 918407,VA,49.0,F,"Patient received vaccine 12/28/20. On 1/2/21, patient develop large, sore, red splotchy area around site of injection. Area itched. As of today 1/4/21, are larger - Patient will be seen by provider to determine if cellulitis and further treatment necessary.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,PVT,Unknown,,Migraines,Redness after TB (Tine) Testing,Unknown,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,IM 918408,FL,44.0,F,Left cheek/ jaw numbness starting 10 min after injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/17/2020,0.0,OTH,Meloxicam omeprazole Tylenol,right shoulder calcific tendonitis,migraines,,fish nuts,['Hypoaesthesia'],1,PFIZER\BIONTECH,SYR 918409,CA,38.0,M,"Patient complained of increased shortness of breath, generalized weakness and fatigue with mild cough worsening today and was admitted on 12/25/20. Patient is an employee of the hospital in the ICU and received the covid-19 vaccine on 12/25/20. Patient believes symptoms started after the vaccination. On admission, patient was in sinus tachycardia with O2 saturation 91% on room air. Tested SARs CoV 2 RNA, RT PCR positive on 12/24/20. Transferred to ICU for closer monitoring after transitioning to high flow nasal cannula on 12/26. Patient recovered and discharged on 12/31/20.",Not Reported,,Not Reported,Yes,7.0,Not Reported,,12/18/2020,12/25/2020,7.0,PVT,,,,,no known allergies,"['Asthenia', 'Cough', 'Dyspnoea', 'Fatigue', 'Intensive care', 'SARS-CoV-2 test positive', 'Sinus tachycardia']",1,PFIZER\BIONTECH,IM 918411,FL,63.0,F,"The day after receiving the vaccine I developed redness, itchiness and some swelling at the injection site. That went away after a couple of days. However on Day #8 redness and itchiness developed again at the injection site and is still present now on Day #10.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,PVT,"Vitamin D3 (6000 IU) , Metoprolol Succ ER 25 mg twice a day, Levothyroxine 112 mcg, Rosuvastatin 5mg, Cuvitru 50ml SubQ every two weeks",None,"hypogammaglobulinemia, hypothyroidism, PVCs, high cholesterol, asthma (not chronic)",,"Bactrim, surgical tape","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 918412,RI,50.0,U,Palpitations and headache,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/28/2020,0.0,UNK,"hydrochlorothiazide 12.5mg, lisinopril 30mg, sertraline 100mg",,"asthma, hypertension",,Sulfa,"['Headache', 'Palpitations']",1,MODERNA,IM 918413,IA,18.0,F,FACIAL SWELLING. EYES SWELLED SHUT. TOOK DIPHENHYDRAMINE ORALLY AT 09:30PM ON 12/30/20. WENT TO SLEEP SHORTLY AFTER TAKING DIPHENHYDRAMINE AND FACIAL SWELLING WAS RESOLVED UPON AWAKENING THE FOLLOWING DAY. RESIDENT STATES SHE TESTED POSITIVE FOR COVID-19 ON 11/10/20,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,,"['SARS-CoV-2 test positive', 'Swelling face', 'Swelling of eyelid']",1,PFIZER\BIONTECH,IM 918414,,62.0,U,Complete loss of appetite,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,PVT,,,,,,['Decreased appetite'],UNK,PFIZER\BIONTECH, 918415,IL,38.0,F,"Pt called on 1/3/2021 to report that after receiving her vaccine on 12/31/2020, she began to experience nausea and lack of appetite. No additional side effects or symptoms reported. No vomiting. Pt able to drink fluids and stay hydrated.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Decreased appetite', 'Nausea']",1,MODERNA,IM 918416,WV,66.0,M,weakness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/28/2020,5.0,OTH,"levothyroxine, cyanocobalamin, cyclobenzaprine, albuterol, propranolol, gabapentin, budesonide inhaler, melatonin, folic acid, metformin, zaleplon, allopurinol, lisinopril, cholecalcif, thiamine, pioglitazone, omeprazole, glipizide, ferrous","htn, hep c, nicotine dependence, dm, vid d def, obesity, hearing loss, tinnitus, esophageal varices, copd, colon polyp, psoriasis, low back pain, allergic urticaria, prostatic hyperplasia, pulmonary nodule, peptic ulcer, thrombocytopenia, cirrhosis of liver, liver disease, lumbago with sciatica, hepatomegaly","htn, hep c, nicotine dependence, dm, vid d def, obesity, hearing loss, tinnitus, esophageal varices, copd, colon polyp, psoriasis, low back pain, allergic urticaria, prostatic hyperplasia, pulmonary nodule, peptic ulcer, thrombocytopenia, cirrhosis of liver, liver disease, lumbago with sciatica, hepatomegaly",,indocin,['Asthenia'],1,MODERNA, 918417,AZ,56.0,M,"Very sore arm near the imjection site. Very painful the next day, but less so the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,UNK,,,diabetes type 2,,,['Injection site pain'],1,PFIZER\BIONTECH,SYR 918418,FL,65.0,M,"Resident became SOB, congested and hypoxic requiring oxygen, respiratory treatments and suctioning. Stabilized after treatment and for the next 72 hours with oxygen saturations in the 90s. On 1/3/2021 was found without pulse and respirations. Resident was a DNR on Hospice.",Yes,01/03/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,SEN,Mucomyst ASA Benadryl Periactin Colace Ferrous Sulfate Folic Acid Gabapentin Sennosides Albuterol Ipratropium Melatonin MVI Oxycodone Polyethylene Glycol Seroquel Rosuvastatin Valproic Acid Venlafaxine Vitamin C,Hypoxia started on 1/1/2021. History of: Osteomyelitis CVA Pain Pressure Ulcers PVD Hepatitis C COPD HTN HLD Constipation SCPT Anemia Seizure disorder Depression AKA,As noted above,,NKA,"['Dyspnoea', 'Hospice care', 'Hypoxia', 'Oxygen saturation decreased', 'Pulse absent', 'Respiratory arrest', 'Respiratory tract congestion']",1,PFIZER\BIONTECH,IM 918419,MI,45.0,M,"Patient became unresponsive for 10-15 seconds. Medical emergency called, along with 911. Upon reobtaining consciousness, patient was diaphoretic and clammy. Vital signs obtained - SBP in the 70s and HR in the 40s. Patient transport to the ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,,,hypotension,,PCN,"['Cold sweat', 'Heart rate decreased', 'Hyperhidrosis', 'Hypotension', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 918420,IA,56.0,F,"12/31/20 - Pain and swelling at injection site, as well as pain and swelling in left arm pit that is not relieved with Tylenol. This has continued beyond 72 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,,,,,,"['Axillary pain', 'Injection site pain', 'Injection site swelling', 'Swelling']",1,PFIZER\BIONTECH,IM 918421,TX,47.0,F,"12/29/2020: My left arm injection site, hand went numb, face and lips were itching, sweating 12/30/2020: headache, nauseous, body ache 12/31/2020: headache, severe body ache & chills, nauseous 01/01/2021: headache, nauseous, 01/02/2021: headache, nauseous 01/03/2021: headache, nauseous 01/04/2021: dull constant headache, nauseous",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,UNK,"1 aspirin a day 81 mg, levothyroxine 112 micorgrams daily",none,"AFIB, ABLATED THYROID",,no that I am aware of,"['Chills', 'Headache', 'Hyperhidrosis', 'Hypoaesthesia', 'Nausea', 'Pain', 'Pruritus']",UNK,MODERNA, 918423,PA,40.0,F,"Racing heart- began directly after injection. Continued for hours. Hyperactivity/sleeplessness- feeling of being wired. No sleep for 43 straight hours. No feelings of tiredness or exhaustion during this time. Hives on left arm, upper chest, and abdomen- began at 36 hours post- injection. Benadryl 25mg taken. Treatment successfully cleared hives without further treatment needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,Birth control- yaz.,None,None,,Aspirin. Penicillin.,"['Feeling abnormal', 'Insomnia', 'Palpitations', 'Psychomotor hyperactivity', 'Urticaria']",1,MODERNA,SYR 918424,WV,57.0,M,"Reports tremors and pain to right arm and hand. Also reports joint pain, especially to right hip area. Reports generally ""not feeling well"".",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/28/2020,5.0,OTH,"Lactobacillus Acidophilus Cap, Bupropion, Trazodone, Colchicine, Chlorhexidine Mouthwash, Testosterone Injection, Potassium Chloride, Tamsulosin, Calcium Polycarbophil, Amlodipine, Hydroxyzine, Allopurinol, Buspirone, Cholecalciferol, Diclo",None,"Hypertension, hypogonadism, depression/anxiety, bariatric surgery, skin removal, bilateral knee replacements, CT repair, BPH, tonsils/adenoids removed, knee scopes, nicotine dependence (chewing tobacco), obstructive sleep apnea, mild intermittent asthma, arthritis, panniculitis, osteoarthritis, male infertility, chronic fatigue, malignant neoplasm of the colon, torsion of testes, malignant neoplasm of right male breast, obesity, carpal tunnel, gout, cervicalgia, chronic kidney disease, benign prostatic hyperplasia without lower urinary tract symptoms, allergic rhinitis, Vitamin D deficiency, hypoglycemia, insomnia",,"Codeine, Tramadol, Darvocet, Bee Stings, Augmentin, Androgel","['Arthralgia', 'Feeling abnormal', 'Tremor']",1,MODERNA,IM 918425,TN,51.0,F,"After receiving vaccine, I felt fine, then at 9pm that night, I started having chills, and being lethargic along with headache and nausea. By Sunday Morning, I had all those sypmtoms all day long, with back vomiting and fever. Today, I feel better, just still feverish and still upset stomach. I will not be going to work today.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,OTH,No,No,No,,Ibprophen,"['Abdominal discomfort', 'Chills', 'Headache', 'Impaired work ability', 'Lethargy', 'Nausea', 'Pyrexia', 'Vomiting']",UNK,MODERNA, 918427,,53.0,F,"The employee received the Moderna vaccine on 12/28 with no obvious post vaccine symptoms until this morning 1/4/2021 at 6:30AM. cc: L upper arm and shoulder pain HPI: c/o L arm and axillary pain after waking up. Pain also felt with touch. Pain with lifting of arm. Patient received Moderna vaccine on 12/28 (7 days ago). Denies fever or chills. PMH: none PSH: Partial Hysterectomy 2008 Meds: MVI Allergies: seafood - rash Peanuts - rash O: L upper arm/deltoid area - + TTP, +swelling approx. 2"" x 3.75"" in diameter, +warmth to palpation; stiff with ROM A: LUE edema s/p covid 19 vaccination P/I: Cold compress applied at 8:45 AM with instructions to apply 15 minutes x 4x/day. Ibuprofen 600mg po given at 11:00AM and q6hrs with food for pain prn. Will monitor",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,WRK,Multivitamins,Denies,Denies,,Seafood- hives; peanut-hives,"['Axillary pain', 'Injected limb mobility decreased', 'Injection site oedema', 'Injection site pain', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Musculoskeletal stiffness', 'Pain', 'Pain in extremity', 'Tenderness']",UNK,MODERNA,IM 918428,IN,44.0,F,INJECTION SITE TENDERNESS PIXELATED VISION MIGRAINE,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,5000 IU Vit D 1000mg Vit C Vital Protein Collagen Peptides 20g,none,none,,erythromycin,"['Injection site pain', 'Metamorphopsia', 'Migraine']",1,PFIZER\BIONTECH,IM 918429,FL,50.0,F,"Burning upon injection; pain and swelling times 12 days; 01/04/2021-large red and swollen hive type appearance around injection site, approximately 4"" long x 3"" wide and warm to touch, palpation is hard to touch",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,"Vitamin B12, Vitamin D3, Calcium, Biotin, Daily Bariatric Multivitamin Cymbalta, Ambien, Topomax",None,Bariatric Surgery April 2018,,NKDA,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site urticaria', 'Injection site warmth']",1,MODERNA,IM 918430,TX,54.0,F,Stayed in clinic for 15 minutes after injection with no problem. 15 minutes after I left the clinic (30 min post vaccine) my face became hot and flushed and my throat felt like there was something in it. The next day I was lethargic and had a bit of swollen throat but no problem breathing.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,benicar loratadine nasonex estradiol patch tylenol,none,high blood pressure obesity,,dairy allergy/sensitivity,"['Hot flush', 'Lethargy', 'Oropharyngeal discomfort', 'Pharyngeal swelling']",1,MODERNA,IM 918432,TX,56.0,F,"Event: Nausea, chills, fever 102.3, body aches, headache, fatigue Treatment: Ibuprofen, Tylenol, Rest Outcome: Okay after 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,"Zyrtec, singular, herbal supplement for arthritis/bursitis",No,No,,No,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 918449,PA,38.0,F,"I started developing a lump at the vaccination site on my left arm the next day. It was very painful, red, swollen and had a big lump. I also started getting itchy there too. My arm was a lot more painful than I've ever experienced from any other vaccines such as the flu shot. I also have never had a reaction to one before. 2 days later I was in the express care for my daughter and had the PA look at it and he said if it doesn't get better by Monday (12/28) call my primary care physician. Monday came around and it started getting better, so I didn't call, by Wednesday it continued to get better but not completely gone. Thursday (12/31) I developed a lump again, painful, swelling, red patch at the injection site, hot to the touch. I had a virtual visit with my primary care physician and he said I'm having an allergic reaction at the vaccination site. He prescribed me 3 days of Prednisone 50mg/day, Claritin 2x daily & Pepcid 2x daily all for 3 days. It has finally resolved now.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,levonorgestrel-ethinyl estradiol 0.15 mg-30 mcg (91) per tablet- Commonly known as: SEASONALE Birth Control famotidine 40 MG tablet- Commonly known as: PEPCID,None,None,,None,"['Injection site erythema', 'Injection site hypersensitivity', 'Injection site mass', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 918450,TN,49.0,F,"12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit to wrist. All over fatigue, joint pain, brain fog, and temp of F. Nausea and headache. 12/30 - Pain in left worse, incressed pain, redness, and swelling at injecition site. Painful swollen area in left armpit. Pain with any movement of left arm. Headache, fatigue, nausea, and muscle weakness. 12/31 - Continued pain in left arm, but improved. Continue to have pain swollen area with warmth and redness size of an orange. Headache and fatigue. 1/1 - fatigue, arm sore. Bilateral arm weakness. 1/2 - headache throughout day, not responsive to Tylenol or Advil, fatigue 1/3 - Vertigo, fatigue 1/4 - Left arm slightly sore to touch, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,none,COVID + 12/18/20,none,,none,"['Arthralgia', 'Axillary pain', 'Fatigue', 'Feeling abnormal', 'Headache', 'Injection site erythema', 'Injection site swelling', 'Muscular weakness', 'Nausea', 'Neck pain', 'Oedema peripheral', 'Pain', 'Pain in extremity', 'Pain of skin', 'Vertigo']",UNK,PFIZER\BIONTECH, 918452,NY,74.0,F,"1-hives under lower lip 2-injecction site sore for 5 days 3-injection site became hot, hard, itchy @ 5 days 4-@6 days above spread in size began taking benadryl 5-area of redness now 6"" by 8"" still itchy, still red @ 8 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,PVT,"synthroid 50 mcg multiple vitamin biotin 10,000 mcg vit c 1000 d3 1,000iu folic acid 800mcg vit E 180 mg fish oil 1200 mg",none,arthritis,,tetanus penicillin sulfur kale spinach IVP Dye,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Urticaria']",UNK,MODERNA,SYR 918453,,40.0,F,Rash over chest and arms,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,UNK,,,,,,['Rash'],1,MODERNA, 918454,MA,64.0,F,"Headache, queasy stomach, fatigue, started date of vaccine, Tues. 12/29/2020, a few hours after I received the vaccine, and lasted until Sat., 1/2/2021 (5 days)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Levothyroxine,"steroid injection in psoas tendon (pain management), 12/22/202","hypothyroid, asthma",,,"['Fatigue', 'Headache', 'Nausea']",1,MODERNA,IM 918455,VA,49.0,F,Patient states that she began having nausea/vomiting and headache after receiving vaccine but this resolved 12/30/20. She states that she did notice the day after vaccination that she would have on and off pink ting of her urine when voiding. Advised her to see her provider to rule out UTI...,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2020,01/01/2021,363.0,PVT,Unknown,,Ulcerative Colitis,,Sulfa and Amoxicillin,"['Chromaturia', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 918456,OK,30.0,F,"Patient began to experience symptoms shortly after vaccination. Pt became flushed and developed red splotches over chest and neck. C/o difficulty swallowing and some GI upset. Began to shake uncontrollably. Initial BP was 149/99 and HR 118. O2 sats at 99%. Administered 25mg of benadryl and monitored patient for approximately 1 hour. After about 30-45 minute, her vitals stabilized at 120/80, Pulse 90, O2 at 100% on room air. D/C'd home at 1:32pm. 24 hours later patient c/o of hives and flushing off and on. Also complained of some GI upset and fatigue. Pt was able to return to work on 1/3/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Unknown,Did not disclose other illnesses,Did not disclose any chronic health conditions,,Did not disclose any allergies. Denied previous anapylactic reactions.,"['Abdominal discomfort', 'Dysphagia', 'Fatigue', 'Flushing', 'Impaired work ability', 'Rash', 'Rash macular', 'Tremor', 'Urticaria']",1,PFIZER\BIONTECH,IM 918457,RI,25.0,U,Neck developed a rash,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/20/2020,2.0,UNK,,,,,,['Rash'],1,PFIZER\BIONTECH,IM 918458,OH,50.0,F,"2am onset (12/30/20) fever to 103, chills, aches. Severe Headache. All symptoms lasted until 8am on 12/31/20 when all symptoms went away except for fatigue that lasted for the next 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,Losartan 25 mg daily,none,none,,NKDA,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 918459,IA,95.0,F,REPORTED DIZZINESS AND WEAKNESS IN LEGS AFTER RECEIVING VACCINE. HAD A PREVIOUS REACTION TO FLU VACCINE. WAS MONITORED FOR 30 MINUTES.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,SEN,,,,"INFLUENZA VACCINE, REACCTION UNKNOWN",,"['Dizziness', 'Muscular weakness']",1,PFIZER\BIONTECH,IM 918460,TN,31.0,F,My lips have been numb since receiving the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PUB,None,None,None,,None,['Hypoaesthesia oral'],1,MODERNA,SYR 918461,VA,47.0,F,"12-29-20 the night of the shot I had cold chills,alittle headache,just alittle facial tingling, joint pain,hot flashes and very tired and sore arm. Day 2 started with sore arm and with back radiating in different part of my back and hot flashes, very tired Day 3 starting with more back pain and some mood swings and very tired. Day 4 to present back pain a lot more and joint pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,OTH,none,none,none,,Sulfa medication,"['Arthralgia', 'Back pain', 'Chills', 'Fatigue', 'Headache', 'Hot flush', 'Mood swings', 'Pain', 'Pain in extremity', 'Paraesthesia']",1,MODERNA,SYR 918462,,35.0,M,"Chills, myalgias and low gray temperature 99.7.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,None,None,None,,None,"['Chills', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 918463,TX,25.0,M,"01/02/21 itching all over body -hives developed except for neck and face; Benadryl dose, resolves then returns 6 hrs later. Hives have not resolved, hives developed on neck and face 01/03/21 in PM. Benadryl treatment continues",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,PUB,"Cingular, ADVAIR DISKUS",,Asthma-controlled,,,"['Pruritus', 'Urticaria']",1,MODERNA,IM 918464,MA,43.0,F,No treatment at this time,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PHM,Xyzal and daily multi-vitamin,headache on 1/3/2021 at 8am,,,Sulfa and shellfish,['Headache'],1,PFIZER\BIONTECH,IM 918465,WA,38.0,F,"On day 8 after the vaccine, developed increased soreness, redness and itch over L deltoid (~ 3"" by 2"" oval at vaccine site) and also from anterior L shoulder (~ 1"" thick streak) stretching about 4 inches toward chest, just under clavicle. Also have headache and some fatigue/malaise, though unclear if this is related to vaccine or several nights of poor sleep with a teething baby.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/03/2021,8.0,PVT,Prenatal Vitamins,None,None,,None,"['Arthralgia', 'Erythema', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Malaise', 'Pruritus']",1,MODERNA,SYR 918466,NE,64.0,F,"LATE EVENING OF 12/30/20 DEVELOPED FEVER, CHILLS, VOMITING, BODY ACHES, AND FATIGUE. LASTED 3 DAYS. IS NOW RESOLVED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,,"['Chills', 'Fatigue', 'Pain', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 918467,MI,58.0,F,Stuffed up head and sneezing. Started on 1-3-2021. I get this every year.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,01/03/2021,33.0,PVT,"Multivitamin, metformin,creator, trulicity, Tylenol,, Nasacort, lisinopril, hydroChlorothiazide, vitamin d3, Allegra",None,Nothing except I need a total knee,,"Codeine, Aspirin, Procada, and she'll fish","['Head discomfort', 'Sneezing']",1,PFIZER\BIONTECH,SYR 918468,OH,29.0,F,"Bulky painful axillary lymphadenopathy each 1-2 cm on the same side as the injection, erythema and warmth around the injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,PVT,None,None,None,,None,"['Injection site erythema', 'Injection site warmth', 'Lymphadenopathy']",1,MODERNA,IM 918469,OH,31.0,F,"PT REPORTED HYPOTENSION/BRADYCARDIC EPISODE, BODY ACHES, CHILLS, FEVER, MALAISE FOR 2.5 DAYS. PT WENT TO HOSPITAL FOLLOWING REACTION. SHE WAS NOT HOSPITALIZED, SEVERE SYMPTOMS RESOLVED WITH REST AND HYDRATION. CONSULTED WITH PCP AND MONITORED FREQUENTLY.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,SEN,UNKNOWN,UNKNOWN,UNKNOWN,,NO KNOWN ALLERGIES,"['Bradycardia', 'Chills', 'Hypotension', 'Malaise', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 918470,VA,59.0,F,TONGUE ITCHING AT 0940; RECEIVED VACCINE AT 0721. REFERRED HER TO HER PCP.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,,,,,,['Tongue pruritus'],1,PFIZER\BIONTECH,IM 918471,NY,36.0,F,"12/22/2021 VACCINE @ 0630 12/22/2021 12:00 RED, SWOLLEN ARM. ROUND, 4 CM CIRCUMFERENTIAL. FIRM EDEMA. PERSISTED THROUGHOUT WEEK. LOOKED LIKE 'SECOND DELTOID' 1/4/2021 STILL MILD REDNESS, ITCHINESS. VERY MILD SWELLING. CONFERRED WITH DR. VIA EMAIL. 'KEEP EYE ON IT'. IMPROVING BUT STILL VISIBLE.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,PVT,"CELEBREX, PLAQUENIL",,SJOGRENS SYNDROME,"FLU, SORE ARM 1-2 WEEK AFTER",,"['Erythema', 'Induration', 'Oedema', 'Peripheral swelling', 'Pruritus']",1,MODERNA,SYR 918472,WV,66.0,M,generalized weakness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/28/2020,5.0,OTH,"levothyroxine, cyancobalamin, cyclobenzaprine, albuterol, propropranolol, gabapentin, budesonide inhaler, melatonin, folic acid, cyancobalamin, metaformin, zaleplon, allpurinol, lisinopril, cholecalcif, thiamine, piglotazone, omeprazole, gl","htn, hep c, nicotine dependence, dm, vid d def, obesity, heari","htn, hep c, nicotine dependence, dm, vid d def, obesity, hearing loss, tinnitus, esophageal varices, copd, colon polyp",,indocin,['Asthenia'],1,MODERNA,IM 918473,KY,40.0,F,"sore arm for 48 hours, headache for 48 hours and burning/hot eyes for48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,UNK,"wellbutrin, lexapro",none,none,,none,"['Eye irritation', 'Headache', 'Pain in extremity']",1,MODERNA,IM 918474,TX,38.0,F,"Day of vaccine: Nausea that lasted about 6 hours. 8 days after vaccine: Site where vaccine was administered light red,itchy, warm to touch, and area was hard. Topical Benadryl cream applied to site: no longer itched. 9 days after vaccine: Site was now bright red and warm and itchy Topical Benadryl applied to site and Oral benadryl dose taken as well. 10 days after vaccine: Site light pink no longer warm or itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/01/2021,8.0,PVT,Levothyroxine 112 mcg,,Hypothyroidism,,Sulfa,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth', 'Nausea']",1,MODERNA,IM 918475,CA,31.0,F,fatigue low grade fever body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,UNK,,,,,,"['Fatigue', 'Pain', 'Pyrexia']",1,MODERNA,SYR 918476,AZ,43.0,F,"Chills, rigors, body aches, headache, low body temp - started 24 hours after vaccine administration and lasted about 8 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,None,None,None,,None,"['Body temperature decreased', 'Chills', 'Headache', 'Pain']",1,PFIZER\BIONTECH,IM 918477,KS,37.0,F,"12/31/20 & 01/01/21- Right side axillary lymph node swelling and tenderness 01/01/20 - Right side cervical lymph node swelling 01/01/20 - injection site swelling, warmth, and redness 01/02/20 - extreme fatigue 01/03/20 - fatigue 01/04/20 - fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PVT,,,,,,"['Fatigue', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 918479,NH,37.0,F,"The patient is a 37-year-old female presenting to the emergency department with an allergic reaction after receiving a Covid vaccine. Began having palpitations and flushing 5 minutes after the injection. Reported a heaviness in her throat. This has not improved but not worsening. Reports some difficulty swallowing. Denies any difficulty breathing. Denies rash. Has never had similar symptoms previously. Denies fever chills nausea vomiting lightheadedness or dizziness. Symptoms have been constant since onset. Has not taken anything to alleviate her symptoms.� Review of Systems Constitutional: Negative for activity change, chills and fever. HENT: Negative for congestion and rhinorrhea. Throat swelling trouble swallowing Eyes: Negative for pain and visual disturbance. Respiratory: Negative for chest tightness and shortness of breath. Cardiovascular: Positive for palpitations. Negative for chest pain. Gastrointestinal: Negative for abdominal pain, nausea and vomiting. Endocrine: Negative for polydipsia and polyuria. Genitourinary: Negative for dysuria and flank pain. Musculoskeletal: Negative for back pain and myalgias. Skin: Negative for rash and wound. Neurological: Negative for weakness and headaches. Psychiatric/Behavioral: Negative for confusion and suicidal ideas. All other systems reviewed and are negative. BP 114/69 | Pulse (!) 106 | Temp 36.9 �C (98.5 �F) (Oral) | Resp 21 | Ht 162.6 cm (5' 4"") | Wt 84 kg (185 lb 3 oz) | SpO2 98% | BMI 31.79 kg/m� Physical Exam Vitals signs and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: She is well-developed. HENT: Mouth/Throat: Comments: Uvula slightly edematous, tongue does not appear swollen, lips are not swollen, no stridor, breathing comfortably and speaking in full sentences Eyes: Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion and neck supple. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No stridor. Abdominal: Palpations: Abdomen is soft. Tenderness: There is no abdominal tenderness. There is no guarding or rebound. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Findings: No rash. Comments: No obvious rash Neurological: Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No cranial nerve deficit.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,No Listed,No,No,,Patient Denies,"['Dysphagia', 'Flushing', 'Hypersensitivity', 'Oropharyngeal discomfort', 'Palatal oedema', 'Palpitations', 'Pharyngeal swelling']",1,MODERNA,IM 918480,NC,59.0,F,"Woke up achy all over with fever and chills. BP was high, so took meds, but didn't help even after taking again later. Contacted physician and advised to come in. Different BP med given that helped. Woke up tired the next morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,WRK,Lisinopril Propanol HCTZ Trintelix Multi-vitamins,,Asthma Hypertension,,"Not allergic, but I don't take codeine because it makes me nauseous.","['Chills', 'Electrocardiogram', 'Fatigue', 'Hypertension', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 918481,,51.0,F,Patient felt lightheaded for approximately 15 minutes,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,,,,,None,['Dizziness'],UNK,PFIZER\BIONTECH,IM 918483,TX,51.0,F,"Ear pain pulling sensation, down my neck numbness jaw locking on same side of injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,01/02/2021,15.0,WRK,None,None,None,,No,"['Ear discomfort', 'Ear pain', 'Hypoaesthesia', 'Trismus']",1,PFIZER\BIONTECH,IM 918484,OH,33.0,F,"About 12 hours after the vaccine I started to have body aches and chills. I took Ibruprofen that evening and when I woke up the next morning I had a low grade fever of 99.5, I took Ibruprofen that morning and began sweating. I was sweaty/clammy all day, had a headache and tired. Around 4pm I took a 1.5 hour nap and felt better after that. The next morning I believe I had another low grade fever because I was really cold when I went to sleep, but woke up sweating. After that I have not had any symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,OTH,Ibruprofen,,,,Penicillin,"['Chills', 'Cold sweat', 'Fatigue', 'Feeling cold', 'Headache', 'Hyperhidrosis', 'Night sweats', 'Pain', 'Pyrexia']",1,MODERNA,SYR 918485,NE,64.0,F,"Chills starting date of vaccine administration. Fever (100.2) for 24 hours. Red, swollen, itchy arm at injection site for 5 days. Body aches for 72 hours. Headache for 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,Covid positive 10/28/2020,none,,NONE,"['Chills', 'Headache', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Pain', 'Pyrexia']",1,MODERNA,IM 918486,NE,57.0,F,"I administered the vaccine and because the patient has a history of anaphylaxis to nuts, we instructed her to stay in the observation area for 30 minutes, instead of the standard 15 minutes. Patient agreed and was monitored by medical staff in the observation area. She began to feel an adverse reaction (which will be described in further detail by Healthcare staff filling our their VAERS report), and was given supportive measures. She did not have to be transferred out of the observation area, and felt completely recovered after intervention were provided. Please see the additional VAERS report filed on this patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PUB,,,,,nuts,['Adverse reaction'],1,MODERNA,IM 918487,MI,94.0,M,Two days post vaccine patient went into cardiac arrest and passed away.,Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,N,01/02/2020,01/04/2021,368.0,SEN,"Loratadine, Plavix, flomax, Lisinopril, atrovastatin, amlodipine, Pentoxifylline, ASA, Donepezil, trazodone, Metoprolol tartrate.","NSTEMI, Dementia, TIA, COVID-19, HTN, CVA, PVD","HTN, PVD, Dementia",,Beta Adrenergic Blockers,"['Cardiac arrest', 'Death']",1,MODERNA,IM 918488,PA,18.0,F,"Covid 19, Fever, Chills, Body Aches, Headache, Left arm numbness, chest tightness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/25/2020,4.0,PVT,Birth Control,,,,"Penicillin, Amoxicillin, Sulfa Drugs","['COVID-19', 'Chest discomfort', 'Chills', 'Headache', 'Hypoaesthesia', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,SYR 918489,WA,66.0,F,"12/31/20 nausea, resolved later in the day, back feeling itchy, hives began to appear01/01/20 back itchy, nausea, vomit several times; 01/02/20 back itchy, nausea, vomit several times, hives covering back; 01/03/20 back itchy, nausea, vomit several times in late after/ early evening. 01/04/2020 hives; all other symptoms resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PVT,Metformin 500mg,Sinus infection-viral,Diabetes,,"Penicillin, Bacterium","['Nausea', 'Pruritus', 'Urticaria', 'Vomiting']",1,MODERNA,IM 918490,RI,56.0,F,"Patient stated to this nurse @ 1100. Stated she had pain @ injection site to L arm. States that, ""the needle went in to deep and touched her bone"".",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,,,,,,"['Injection site pain', 'Wrong technique in product usage process']",2,PFIZER\BIONTECH,IM 918491,ME,40.0,M,"This is a 40 y.o. female who presents with abrupt onset of nausea vomiting, diarrhea, myalgias, headache about 2 hours after receiving her 1st Moderna COVID-19 vaccine at 1300 hrs.. She describes myalgias extending from the area of her left deltoid injection site over her shoulders and over her entire upper body. No neck or back pain. She describes diffuse throbbing headache with no positional component. She has had relentless nausea vomiting and retching. She has been up vomiting stomach contents to bile multiple times. She has had loose watery brown diarrhea multiple times. She describes diffuse abdominal crampy pain with increased tearing retching and vomiting. She denies any shortness of breath cough or wheezing. Voice is normal. No swallowing dysfunction or pain. No intraoral or facial swelling. She denies rash or pruritus. No arthralgias. Patient reports prior anaphylaxis with shortness of breath and tight airways, difficulty speaking and swallowing, and relationship to coconut ingestion few years prior. No other known food/nut reactions. Patient is a CNA for care at home. Last Covid test was 2 weeks ago which was negative. She reports she has been tested every 2 weeks routinely. Review of Systems Cardiovascular: Negative for chest pain and palpitations. Gastrointestinal: Positive for abdominal pain, diarrhea and nausea. Negative for vomiting. Musculoskeletal: Positive for myalgias. Negative for arthralgias, back pain and neck pain. Neurological: Positive for headaches. Negative for dizziness, weakness and numbness. Physical Exam BP 126/73 | Pulse 120 | Temp 37.1 �C (98.8 �F) | Resp 18 | Ht 1.575 m (5' 2"") | Wt 68 kg (150 lb) | SpO2 100% | BMI 27.44 kg/m� ED Course as of Dec 30 2340 Wed Dec 30, 2020 2128 Reevaluation: Nausea improved. Abdominal cramping resolved. No further diarrhea or vomiting. Still complains of headache and muscle cramping through her upper shoulders and arm. Will remedicate with steroid and acetaminophen 2258 Reevaluation: Patient improved. Pain/myalgias improved. Headache now mild and dull. Continues with no further.nausea vomiting or diarrhea. She would like to try fluids at this time. Assuming toleration we will plan on discharge home. 2326 Reevaluation: Patient feels improved. Headache essentially gone. Taking p.o. fluids well. Discharge instructions discussed. She is very familiar with an EpiPen because of her daughter's prior use. Discharge instructions discussed. ASSESSMENT and PLAN This is a 40 y.o. female who presents with nausea vomiting diarrhea, myalgias, diffuse abdominal cramping, severe global headache, onset about 2 hours after first dose Moderna COVID-19 vaccine. Exam with intact mental status, neurologic system. Abdomen with some diffuse tenderness but no evidence of peritoneal sign. She had diffuse palpable soft tissue muscular type tenderness through her upper extremity shoulder and bilateral paraspinal back. She had no meningeal signs. She had no cardiorespiratory signs or symptoms. Her chest was clear. Voice normal. Swallowing normal. Oropharyngeal region normal. Initial ED ED management focused on rehydration, antiemetics and subsequent treatment for presumptive anaphylaxis with likely system involvement gastrointestinal and neurologic. She was treated with Solu-Medrol, famotidine and acetaminophen. She improved during ED course and did not require epinephrine. Symptoms at ED reevaluation/discharge were resolved. Clinical impression favors anaphylaxis over medication side effect given time course and abrupt onset of symptomatology and signs. She has a distant history of anaphylaxis to coconut-based product in her past. She has no history of ongoing allergic chronic history otherwise. Other organ systems appeared stable at onset and through ED course including cardiovascular and pulmonary. Plan is for discharge home with rest fluids. She will have a course of steroids/prednisone and famotidine. She was sent home with an EpiPen and understands use and precautions. Discussed ED ""return immediately if"" parameters with patient. Ongoing FOLLOW UP evaluation/care coordination via PCP recommended. Patient voices good understanding of current evaluation, follow-up & return recommendations and discharge instructions. Encounter Diagnosis Anaphylaxis due to vaccination, initial encounter Plan: -d/c home. No work next 2 days. Off work note provided -COVID-19 testing pending -rest with activity as tolerated -diet as tolerated & increased fluids as discussed -acetaminophen PRN -Prednisone 40 mg daily to finish 4 more days -Famotidine 40 mg daily to finish 4 more days -Zofran as needed (patient has at home) -Loratadine 10 mg OTC as needed -PCP f/u -ED return for interval worsening -instructions discussed & as documented",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,bisacodyl 10 MG Supp docusate sodium 50 MG Cap Sennosides (senna) 8.6 MG Tab clobetasol propionate 0.05 % Ointment lidocaine 5 % Patch cetirizine 10 MG Tab citalopram 40 MG Tab acetaminophen 500 MG Tab,Colitis 12/5/2020,"Anemia, unspecified � Urinary tract infection, site not specified � Depression � Hailey-hailey disease",,Betadine (Povidone Iodine) Coconut Flavor Gabapentin Percocet (Oxycodone-Acetaminophen) Sulfa Antibiotics Rash,"['Abdominal pain', 'Anaphylactic reaction', 'Diarrhoea', 'Headache', 'Lacrimation increased', 'Muscle spasms', 'Myalgia', 'Nausea', 'Retching', 'Vomiting']",1,MODERNA,IM 918492,OH,47.0,F,"Caregiver developed a metallic taste in her mouth and nausea twelve minutes after the vaccine injection (1404). Sixteen minutes after the start of the symptoms (14:20), the symptoms lessened. She was given soda crackers and water. At 14:54, she denied any nausea nor metallic taste in her mouth. She was allowed to leave observation area. Caregiver was called the next morning (01/01/21 @ 9:00 am) for a follow-up conversation. She stated that at 2am on 1/1/21, she developed a fever (101) and chills. She went to the Emergency room who performed a CXR, lab work, IV fluids and IV medication (Toradol) to help fever. She states a COVID test was completed and the result was negative per caregiver. She was discharged to home with an antibiotic and told her diagnosis was ""possible reaction to the COVID vaccine and Flash pneumonia."" Caregiver spoke to over the phone on 1/4/21 at 10 am. She states she is starting feeling better yesterday and has no complaints today. She is still on antibiotics by mouth and is scheduled to work tonight.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Insulin IV continuous infusion,Diabetes,Diabetes,,Unknown,"['Chest X-ray', 'Chills', 'Dysgeusia', 'Laboratory test', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 918493,OH,41.0,F,"?Moderna COVID- 19 Vaccine EUA? Flu vaccine allergy discussed at length with patient prior to Moderna vaccine. Patient's arm became red and very swollen on two separate occasions after receiving flu vaccine but patient did NOT experience difficulty breathing, respiratory distress, throat swelling, shortness of breath, or anaphylaxis. Approximately 11 minutes after receiving Moderna vaccine, patient complained of warmth and redness at injection site. Immediately after this complaint, patient began to faint and complain of difficulty breathing and pain when breathing. Rapid response was called. Patient continued to complain of painful inspirations and difficulty breathing. EpiPen, albuterol inhaler, and diphenhydramine IM were administered. Patient improved and was transported to emergency room for further monitoring. Patient improved in emergency room and was discharged sooner after.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,"flu vaccine, arm redness and swelling","dexamethasone (no reaction given), hydrocodone (no reactions given), flu vaccine (redness and swelling of arm on two separate occasions after receiving flu vaccine, no respiratory distress, no throat swelling, no difficulty breathing, no anaphylaxis)","['Dyspnoea', 'Full blood count', 'Injection site erythema', 'Injection site warmth', 'Metabolic function test', 'Painful respiration', 'Syncope']",1,MODERNA,IM 918494,CA,53.0,F,"Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness, felt presyncopal,, facial flushing, throat pressure, had elevated BP, itchy cheeks, nausea, chest pressure. Went to ER where they treated her like she had an anxiety attack. No epi given. Patient consulted with her own private ENT?allergist Dr. the next day who states it sounded like a reaction and prescribed Xyzal",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,PVT,,,,,"states some food intolerance, never an anaphylactic reaction. tape sensitivity. Reports sensitive to hypoxy resins.","['Anxiety', 'Blood pressure increased', 'Chest discomfort', 'Dizziness', 'Flushing', 'Nausea', 'Oropharyngeal discomfort', 'Presyncope', 'Pruritus']",1,PFIZER\BIONTECH,IM 918495,MO,41.0,F,"is 5 X 5.5 CM. States redness started on 12/23/2020, redness expanded 12/28/2020 and swelling increased. States the area is painful and redness has heat. Does not feel the skin is taught.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/23/2020,1.0,PVT,,,,,Augmentin,"['Erythema', 'Pain', 'Skin warm', 'Swelling']",1,MODERNA,IM 918496,CA,47.0,F,"Arm pain on the second day Saturday, Not able to lift arm",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,UNK,,,,,,['Pain in extremity'],1,MODERNA,SYR 918497,IA,33.0,F,Knot developed distal to the injection site 2 days following injection which remained until 8 days following the infection when it turned into a circular rash with associated itching,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/29/2020,3.0,WRK,,,,,Penicillin,"['Infection', 'Nodule', 'Pruritus', 'Rash']",UNK,MODERNA,IM 918498,NY,47.0,F,"has rash to lower back/ribs/hips/back of neck - itchy - denies trouble breathing - ""tongue feels tingly"", no itchiness in throat",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/27/2020,1.0,PUB,none reported,,prior treatment with ICS/LABA also with sinusitis no surgery,,"bees, had immune desensitization from age 15-23","['Paraesthesia oral', 'Pruritus', 'Rash']",1,MODERNA,SYR 918499,WI,27.0,F,"lightheaded, dizzy, tunnel vision, sweaty, felt like passing out within minutes of receiving vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,clindamycin,"['Dizziness', 'Hyperhidrosis', 'Tunnel vision']",1,PFIZER\BIONTECH,IM 918500,KY,55.0,F,Development of cellulitis at injection site. Treated at Hospital on 1/3/20 emergency department. With follow up visit scheduled on 1/6/2021 with physician.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/24/2020,1.0,PVT,valsartan 320mg,none,none,,"tomatoes, bee stings, grass pollen, tree pollen,",['Injection site cellulitis'],1,MODERNA,IM 918501,MS,49.0,M,Employee tested positive for Covid-19 5 days after shot,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/29/2020,5.0,PVT,unknown,Employee reported being tired at time of vaccination.,unknown,,unknown,"['COVID-19', 'SARS-CoV-2 test positive']",1,MODERNA,IM 918502,MD,72.0,F,"Moderna COVID-19 Vaccine Patient reported the following via an email following vaccination: ""I had the vaccine on Saturday and only had a slight sore arm but last night my tongue is slightly swollen and very sore and the roof of my mouth ? kind of like I after you burn your mouth on something and the aftermath.""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/03/2021,1.0,PVT,,,,,,"['Oral pain', 'Pain in extremity', 'Swollen tongue']",1,MODERNA,IM 918505,PA,43.0,F,ACHINESS TO LEFT ARM. 7 HOURS AFTER RECEIVING VACCINE EXTREMELY PAINFUL WITH DECREASE ROM.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,MACROBIA,UNKNOWN,ARTHROFIBROSIS RIGHT KNEE,,LATEX,"['Joint range of motion decreased', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 918506,WA,54.0,M,"Dizziness started in the early morning approximately 12 hours after vaccination. The sx's come in waves and affect my balance. Sx's are sometimes exacerbated by change in position and first occurred whenever I rolled over in bed. The sx's also occurred while sitting at a desk working on my computer. No benefit from Eply's maneuvers. No nystagmus with Dix Hallpike maneuver. Meclizine seemed to be helpful. Sx's have persisted this morning, 1/4/2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PVT,"Vitamin C, Vitamin D, Zinc, Fish oil, B12, levothyroxine, Zyrtec",none,hypothyroid,,none,"['Balance disorder', 'Dizziness']",UNK,MODERNA,IM 918507,OH,58.0,F,"Moderna COVID- 19 Vaccine After the 15 minute monitoring period after vaccine administration, patient complained of abdominal itching, no throat itching, no swelling, no difficulty breathing. Patient was given diphenhydramine 25mg oral liquid and asked to stay for additional 15 minutes of monitoring. After additional 15 minutes, patient stated that itching has improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,,,,,,['Pruritus'],1,MODERNA,IM 918509,TN,46.0,F,"Patient states injection site (left deltoid) abruptly turned red, warm, swollen, and itchy on 1/3/21 around 2:00 pm. Patient took Benadryl before bed on 1/3/21 and woke up this morning with no relief.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/03/2021,10.0,PUB,No,No,No,,No,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 918510,,61.0,M,"The patient received his vaccine on Thursday, 12/31/20 between 2:00pm and 2:30pm. The patient did not complain of any ADRs or fever immediately following the injection. However, the next day the patient fell in his room and when vitals were collected, he had a temperature of 102 F. Since the patient was febrile, him and his roommate were given rapid COVID tests, both of which were negative. The patient's PCR test has not come back yet. Per nursing report, the patient did not experience fever again over the weekend, it was a 1x occurrence. His temperature returned to normal on Saturday 1/2/21 and remained normal through Monday, 1/4/21. Besides fever, the patient did not complain of any other ADRs.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,UNK,,,,,,"['Fall', 'Pyrexia', 'SARS-CoV-2 test', 'SARS-CoV-2 test negative']",1,MODERNA,IM 918511,CA,48.0,M,Onset of mild skin rash over 80% of the body within 24 hours of vaccination. Treated with Benadryl.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,"Prescription Meds: Lisinopril 5mg Daily Supplements: D3 (5000 IU Daily), A/D/K (5mg Daily), Zinc (50mg daily), Quercetin (1000mg Daily), CoQ10, B12 (1000mcg Daily), Men's Multivitamin Daily Over the Counter: Baby Aspirin (81mg Daily)",None,None,,None,['Rash'],1,MODERNA,SYR 918513,AZ,63.0,F,"30 minutes after injection, bodily itching relieved after oral Zyrtec <24 hrs after injection, fever > 101, headache, severe body aches, nausea, fatigue . Symptoms lasted >24 hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,none,none,none,"Flu vaccine, 12/2018, hives, itching, throat constriction,",,"['Fatigue', 'Headache', 'Nausea', 'Pain', 'Pruritus', 'Pyrexia']",1,MODERNA,IM 918514,OH,52.0,M,"?Moderna COVID- 19 Vaccine EUA? Patient received vaccine on 12/23/2020, complained of swollen lymph notes on 1/1/2021. Patient also experienced chills, fever 12 hours following vaccine administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/01/2021,9.0,PVT,,,,,,"['Chills', 'Lymphadenopathy', 'Pyrexia']",1,MODERNA,IM 918515,CA,50.0,F,"Headache, pain 7/10, started 3 hours after received vaccine, decreased to 2/10 with tylenol. Lasted for 48 hours and then periodically for an additional 24 hours. Required ATC tylenol for around 48 hours. Arm pain at injection site lasted for 48 hours Fatigue lasted 24 hours Myalgias (other than at injection site), lasted 26 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Vitamin D, pepcid, claritin, symbicorte, singulair",None,Asthma,Rash following pneumovax,None,"['Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Pain']",UNK,MODERNA, 918516,NE,30.0,F,"I administered the vaccine and as the patient has a history of childhood anaphylaxis to shellfish, I instructed her to wait for 30 minutes in the observation area, instead of the standard 15 minutes, It was in the observation area, where she was being observed that she began to feel ""hot and flushed"". The health staff observing will also be submitting a VAERS report, as they provided interventions to the patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,,,,,shellfish,"['Feeling hot', 'Flushing']",1,MODERNA,IM 918517,MO,50.0,F,Low grade fever HA Induration at injection site with redness and warmth Antibiotics prescribed by PCP after a phone call with the patient for possible cellulitis,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,,none,"HTN,DM II, ASTHMA,OBESITY,FIBROMYALGIA",,"Paxil,Quinine,Soma","['Headache', 'Injection site erythema', 'Injection site induration', 'Injection site warmth', 'Pyrexia']",1,MODERNA,IM 918518,NE,50.0,F,syncopal episode - arrested - CPR - death,Yes,12/31/2020,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,To be determined,To be determined,To be determined,,To be determined,"['Autopsy', 'Cardio-respiratory arrest', 'Death', 'Resuscitation', 'Syncope']",1,MODERNA,IM 918519,TX,58.0,M,"Inflammation to left ankle and both knees to the point that I was not able to walk. I have gout attacks but this was nothing like a gout attack. I took gout medication and did not help. only time and rest allowed the ankle to go down. I am schedule to see another doctor to check if the inflammation has anything to do with blood circulation, heart issue, both issue new to me",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/15/2020,12/17/2020,2.0,MIL,"Lipitor, Lisinopril, Zyloprim, KETO pills, vitamin C & D",none,"Herniated Back Disk, Prostate Cancer, high cholesterol, high blood pressure",,none,"['Arthritis', 'Gait inability', 'X-ray normal']",1,PFIZER\BIONTECH,SYR 918522,ME,48.0,F,"12/22/20, 13:36: 6 minutes after receiving the 1st Pfizer vaccine injection, there was stiffness felt behind my ears and in the back of my neck. 10 minutes after the injection, there was a fullness noted along my throat and upper pallet. The symptoms only slightly lessened after 30 minutes. I have a hx of Rheumatoid Arthritis, completing prednisone doses 4 days ago and currently taking Celebrex and IBU daily. The Benadryl liquid dose (25mg) taken at 14:15 completely resolved my reaction symptoms by 15:15.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Musculoskeletal stiffness', 'Palatal swelling', 'Pharyngeal swelling']",1,PFIZER\BIONTECH,IM 918523,NY,19.0,F,"First few days nothing besides arm pain. 1/1/2021- to present 1/4/2021 headache, nausea, vommiting, feeling feverish and chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PVT,Lexapro,None,None,,Tree nuts,"['Chills', 'Headache', 'Nausea', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting']",1,MODERNA,SYR 918524,OH,40.0,F,"?Moderna COVID- 19 Vaccine EUA? After 15 minute monitoring time, patient complained of metallic taste in mouth. She described it as similar to ""the taste you get after a saline flush"".",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,,,,,,['Dysgeusia'],1,MODERNA,IM 918525,,88.0,F,Resident unresponsive. Responds to painful stimuli. Arms flacid.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,SEN,"Healthy Eyes Tablet, Glimepiride, Januvia, Lasix, Potassium, Folic Acid, Ultram, Ativan, Tylenol Arthritis, Humelog",,"Anemia, Hypocholemia; Diabetes, Malignant Neoplasm of Head, Anxiety, Generalized Muscle Weakness, Alzheimer's, Major Depressive Disorder",,"Oxycodone, penicillan","['Hypotonia', 'Unresponsive to stimuli', 'Urinary tract infection']",1,PFIZER\BIONTECH,SYR 918527,NJ,25.0,F,"Vaccine recipient reported feeling lightheaded and had a tickle in her throat. She reported to then have developed an odd taste in her throat *unable to describe?. The vaccine recipient also developed arm pain and swelling around the injection site. The vaccine recipient was sent to the ED for further observation with no medical intervention needed. They were discharged stable to home. On a follow-up call today 1/4/2021, vaccine recipient reported that symptoms went away and they have recovered. Moderna COVID- 19 Vaccine EUA.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,"Zoloft 50 mg, Pepcid 40 mg, birth control",None,Anxiety,,None,"['Dizziness', 'Injection site swelling', 'Pain in extremity', 'Taste disorder', 'Throat irritation']",1,MODERNA,IM 918528,AL,46.0,F,"Received dose #1 at 0830. Severe pain at and around injection site by 1000. Unable to abduct arm by 1030. Took Tylenol 650 mg po around 1130. Pain eased but never went away. On the night of the injection, chills, inability to warm up, sweating, and GI upset started and lasted into the next day. Injection site pain remained until day 3.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,Synthroid Norvasc,nonw,Hypothyroidism Reynaud's Condition,,none,"['Abdominal discomfort', 'Chills', 'Hyperhidrosis', 'Injection site pain', 'Mobility decreased']",1,MODERNA,IM 918529,OK,49.0,F,"10 min after initial injection, I experienced a brief flush of heat that resolved after a few minutes. 6 hours later, I had a sudden onset of intense heat, diaphoresis, and a rash to my arms/legs, along with intense muscle tremors, nausea, vomiting and stomach cramps.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,Methylphenidate,None,Multiple Sclerosis,,None,"['Abdominal pain upper', 'Feeling hot', 'Hot flush', 'Hyperhidrosis', 'Nausea', 'Rash', 'Tremor', 'Vomiting']",1,PFIZER\BIONTECH,IM 918530,,58.0,M,"30 minutes after receiving the vaccine the patient developed hives, scratchy eyes, and a scratchy throat. He reported to the ED and was given Benadryl, methylprednisolone, and famotidine. His symptoms resolved and he was shortly thereafter discharged.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,None,None,None,,"Penicillin, sulfa antibiotics","['Eye irritation', 'Throat irritation', 'Urticaria']",1,PFIZER\BIONTECH,IM 918531,IL,54.0,F,Arm Pain at injection site - pleased to report nothing else. Thank you,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/28/2020,0.0,PVT,,,,,,['Injection site pain'],UNK,PFIZER\BIONTECH,IM 918532,MI,27.0,F,"I received my first dose of the COVID-19 vaccine on 12/22/2020 in the left arm. Immediately at the time of the administration, I noticed numbness in my left pinky & ring finger that extended to my elbow. I figured they may have ?hit a nerve? so I called my PCP afterward. My PCP advised me to take Ibuprofen 600mg and to call the next day with any new or worsening symptoms. When I woke up the next day, I noticed numbness in both of my feet (with continued numbness in my left forearm). I had a visit with my PCP where I had a normal neurological exam except for the paresthesias. I did not sleep well the night before, so I was sent home with a medication to assist in sleeping and to observe over the holidays to see if my condition improved. Otherwise, my PCP would order more testing. Monday after the holidays (12/28/2020), my symptoms didn?t improve. I noticed that I have constant numbness in bilateral hands and feet with periodic episodes where my entire left leg and then my entire right arm had tingling/numbness/crawling sensation. I had some fasting labs done on 12/29/2020: CBC, CMP, CRP, Sed Rate, TSH, Magnesium, eGFR were all within normal limits. My B12 was slightly low at 210 (normal levels are listed as 211-911). I received a B12 injection that same day and started OTC B12 supplements. I am currently waiting on the referral to go through an EMG. Since receiving my B12 injection, I noticed a few more episodes over the New Year holiday break. From 12/31/20-01/02/21, I had this tingling/unpleasant sensation episode on my whole right side. My entire arm and leg were being affected; the episode was constant throughout most of the day with a few moments of relief with hot showers/heating blanket. No weakness noted. I currently have a message out to my PCP to update.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,OTH,Lutera,Anxiety,Anxiety,,No known allergies,"['Blood magnesium normal', 'Blood thyroid stimulating hormone', 'C-reactive protein normal', 'Full blood count normal', 'Glomerular filtration rate normal', 'Hypoaesthesia', 'Laboratory test normal', 'Red blood cell sedimentation rate normal', 'Vitamin B12 decreased']",UNK,PFIZER\BIONTECH,IM 918533,,52.0,F,"Temperature of 103 F, nausea, vomiting, diarrhea for 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,none,,Rheumatoid Arthritis,,,"['Diarrhoea', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 918534,OR,36.0,F,"The day after injection I developed severe soreness, redness, swelling, and what felt like a knot at injection site. Pain and swelling have decreased, but redness and itching and the knot are still there and not improving. Reddened skin also is slightly warmer than unaffected surrounding tissue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/28/2020,1.0,PVT,,,,,,"['Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site swelling', 'Skin warm']",1,MODERNA,IM 918535,CT,42.0,F,1/3/21 noted a red lump/hive looking mark on the injection site. Mark was warm to touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,01/03/2021,8.0,WRK,"Fish Oil, Vitamin C, B12 and Folic Acid",None,None,,Skin allergies to fabric softeners and stick deodorant,"['Injection site mass', 'Injection site warmth']",1,MODERNA,SYR 918536,WI,49.0,F,"Had vaccine on 12/24 and red, warm at injection site size of golf ball. Going to Occ Health for evaluation",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/25/2020,1.0,WRK,,,,,,"['Injection site erythema', 'Injection site warmth']",UNK,MODERNA,IM 918537,TX,50.0,M,"Redness, swelling, and pain to injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/03/2021,3.0,PVT,"xigduo, Levimer, Victoza, Lisinopril, HTCZ, Pravastain",None,"Diabetes, High Blood Pressure,",,NKDA,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,PFIZER\BIONTECH,IM 918538,TX,19.0,F,"""Woke up at 1am with nausea, flushed in the face, hives and bumps on face and back. Lasting approximately 4-5 hours""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,,,,,,"['Flushing', 'Nausea', 'Sleep disorder', 'Urticaria']",1,MODERNA,IM 918539,ND,47.0,F,"Not feeling well the evening of the vaccine, began running a temp that evening with aches, chills headache. The following day continued to run a temp of 103.6 F, aches, fatigue, chills, headache, and tachycardia (120 bpm). The following day, developed itching w/o rash. Itching and fatigue lasted for approximately 8 days, the other symptoms subsided after approximately 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PUB,Gabapentin - Topamax - claritan,,Migraines,,Codeine and Amitriptyline,"['Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Malaise', 'Pain', 'Pruritus', 'Tachycardia']",1,MODERNA,IM 918540,TX,72.0,F,Redness and swelling at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/04/2021,9.0,PVT,"tylenol, calcium, fish oil, vit D, B12, CO-Q 10, Vit C, BP med x 2, gout med, pepcid",,hypertension,"redness and swelling,48 YO,flu vaccine, unk date,type and brand",morphine,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 918541,UT,43.0,M,"10 min after injection, my mouth started getting hot, then it moved down my throat and it was difficult and painful to swallow. I got quite dizzy. They initiated rapid response, when they came they simply monitored symptoms and Vitals. Blood pressure and Heart rate were elevated. after about 10 min the symptoms eased, but swallowing was still difficult and slightly painful. then a second wave of dizziness hit me and I nearly passed out. my heart rate was elevated once again and had ringing in ears. these symptoms lasted another 5-10 min then eased. I then had a headache. The symptoms didn't return, just a headache and fatigue the rest of the day. i was then given option to go to ED, which i didn't feel at that time I needed, so I left. The next day, i had some standard symptoms of pain in left arm from injection, and fatigue, but then toward the evening i developed a fever of 101 deg F than continued for a couple of hours. I used ibuprofen and Tylenol rotating to keep the fever down. On day 3 only mild fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"Omega-3 (fish oil pill), Atorvastatin, Metformin, Vitamin D","Had Covid, tested positive 11/6/2020, still have residual issues of not being able to smell or taste well. have also had chronic congestion and nasal drip since then.",Diabetes (just diagnosed 2020),,"Penicillin, commpazine","['Blood pressure increased', 'Depressed level of consciousness', 'Dizziness', 'Dysphagia', 'Fatigue', 'Feeling hot', 'Headache', 'Heart rate increased', 'Odynophagia', 'Oral discomfort', 'Pain in extremity', 'Pyrexia', 'Tinnitus']",UNK,PFIZER\BIONTECH,IM 918542,AL,39.0,M,"After receiving his vaccine today, immediately he turned red, he stated he felt like his stomach dropped(like being on a roller coaster), and had a brief moment for about 30-45 seconds of chest tightness, all symptoms that he has when he eats seafood (has seafood allergy).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,Seafood,"['Abdominal discomfort', 'Chest discomfort', 'Erythema', 'Immediate post-injection reaction']",1,PFIZER\BIONTECH,IM 918543,,58.0,F,103 F temperature for 3 days after vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,None,None,,,,['Body temperature increased'],1,PFIZER\BIONTECH,IM 918544,,54.0,F,This patient tested positive for COVID19 on 12/28/20. The purpose of this VAERS submission is in response to the request from the agency to input all patients who tested positive for COVID19 after receipt of the COVID19 vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/28/2020,10.0,PVT,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 918545,NJ,61.0,M,"Right side of face tingly, slightly numb. Tingly feeling was gone the next day. Slightly numb feeling lasted at least three or four days. Right arm was sore for four days. Until 12/28, pain in upper right arm would start for no reason, usually in the evening.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,,,,,,"['Hypoaesthesia', 'Injection site pain', 'Pain in extremity', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 918546,MI,32.0,M,Headache on 12-19-2020. Tested covid positive on 12-21-20,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/20/2020,3.0,PVT,None,None,None,,None,"['COVID-19', 'Headache', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 918547,NY,60.0,F,"ITCHING AND SWELLING IN BOTH HANDS AND ONE FOOT WITH PAPULES ON HANDS 1 1/2 WEEKS AFTER VACCINE. PROGRESSING OVER 3 DAYS. WORSE IN THE MORNING, SOME RELIEF WITH ANTIHISTAMINES.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/01/2021,10.0,WRK,"vitamin C, vitamin D3, estradiol gel, turmeric",,osteopenia,,none known,"['Papule', 'Peripheral swelling', 'Pruritus']",1,MODERNA,IM 918548,VA,36.0,F,Received vaccination on 12/30/20. Around 330a on 12/31/20 began to have chills and fever of 101. Arm soreness where injection occurred. Had nausea.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,Unknown,Covid + end of October 2020,Unknown,,Fentanyl,"['Chills', 'Injection site pain', 'Nausea', 'Pyrexia']",1,MODERNA,IM 918549,KS,50.0,F,"soreness of arm, pain moved to armpit, tender to touch",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,PUB,"Stelara monthly, Lexapro, Nature supplements",,"Crohn's, arthritis",,"bees and wasp venom, sulfa","['Axillary pain', 'Pain in extremity', 'Tenderness']",1,MODERNA,IM 918550,AZ,26.0,F,"By evening, arm around the injection site grew increasingly painful, to the point where it hurt to move or touch (not unbearable but more soreness than any other injection I've ever received). Over night contracted a fever, by the time I was able to get up to measure it (around 3:45 AM) it was 99.5 degrees, and broke by 5 AM. Had fever dreams prior to waking around 3 AM, and had chills for the remainder of the night. Felt achy and a little unsteady for the rest of the day but was fully recovered by 12/31",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,UNK,"Mini pill (norethindrone) only birth control pill Calcium with Vitamin D supplement Kava Kava liquid herbal Stinging Nettles herbal Zyrtec Aleve (for the fever) Other supplements not taken that day (D, B12, Biotin, Intestamine, Phyto-ADR)",None,Asthma,,"Sulfa Gluten Dairy Peanuts, Almonds (not an anapyllactic allergy) Soy Corn","['Abnormal dreams', 'Balance disorder', 'Chills', 'Injection site pain', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 918551,MN,37.0,F,My lymph nodes in back of my throat swollen and I had joint pain. Also had a fever of 102.9.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,None,None,None,,I'm allergic to penicillin,"['Arthralgia', 'Lymphadenopathy', 'Pyrexia', 'Streptococcus test']",2,PFIZER\BIONTECH,IM 918552,IL,39.0,F,"Severe diarrhea, cold chills, 101 fever, and nausea",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,None,Lupus,Lupus,,NKA,"['Chills', 'Diarrhoea', 'Influenza virus test negative', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative']",5,MODERNA,IM 918553,TX,19.0,F,"Woke up at 1am with nausea, flushed in the face, hives and bumps on the face and back. Lasting approximately 4-5 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,,,,,,"['Flushing', 'Nausea', 'Rash', 'Urticaria']",1,MODERNA,IM 918554,MI,42.0,F,"Tongue swelling after receiving COVID-19 vaccine. No difficulty breathing, no rash. Claims posterior aspect of tongue is swelling and causing her a gagging feeling. No chest pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,PVT,Flexeril Xanax Cardizem Symbicort Cadura Synthroid Glucophage Pravachol Aldactone albuterol EpiPen,,Diabetes Hypothyroidism Dysphagia Asthma,,Benadryl Claritin Levaquin Losartan Sulfa Drugs Ace Inhibitors,"['Retching', 'Swollen tongue']",1,MODERNA,IM 918555,IN,31.0,F,"Patient is allergic to Bactrim, hence she was told to wait 30 minutes after she was vaccinated. About 15 minutes waiting time she started c/o numbness to her left leg.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,Nexplanon,None,None,,Bactrim,"['Blood glucose normal', 'Hypoaesthesia']",1,MODERNA,IM 918556,MI,43.0,F,"Had severe chills when I went to bed. Woke up around 1:45am with severe pounding headache, fever, body aches, heart racing. 911 was called for fear of getting worse, however vital signs were stable so I stayed home and declined visit to ER. I had COVID in September",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,WRK,birth control zyrtec fiber capsules,none,endometrosis,,penicilin,"['Chills', 'Headache', 'Pain', 'Palpitations', 'Pyrexia']",1,MODERNA,IM 918557,MA,35.0,F,Beginning 4 to 5 hours after vaccine shoulder pain and stiffness continues to worsen over 5 days before improving with Ibuprofen. Shoulder pain worsened again after increased use 1 week after injection became difficult to move due to pain and stiffness. Has improved again with consistent use of Ibuprofen.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,none,none,none,,none,"['Arthralgia', 'Mobility decreased', 'Musculoskeletal stiffness']",1,MODERNA,IM 918558,NY,38.0,F,"Moderna COVID-19 Vaccine EUA Localized rash noted to torso (bra line to belly button). Rash not raised, no hives, no itching. No oral or topical medications used. Rash self resolved in 24hrs from when first noted.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,Multivitamin,None,"Asthma,seasonal allergies, anxiety",,"penicillin, shellfish",['Rash'],1,MODERNA, 918559,PA,42.0,F,"Flushing, angioedema, urticaria, dizziness; light headedness; bad taste in back of mouth ; nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,Valtrex zyrtec,none,asthma- moderate Seasonal allergies,,none,"['Angioedema', 'Dizziness', 'Flushing', 'Nausea', 'Taste disorder', 'Urticaria']",1,MODERNA,IM 918560,WA,26.0,F,"Upon immediate injection, reports joint pain on inner left wrist and left thumb. Day 2- present, experiencing increased joint pain on left wrist and thumb as well as swelling at base of thumb and inability to move, pinch, grab, stretch left hand. Occasionally pain spread up left forearm to elbow.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,WRK,none,none,none,,Amoxicillin,"['Arthralgia', 'Immediate post-injection reaction', 'Mobility decreased', 'Pain in extremity', 'Peripheral swelling']",1,PFIZER\BIONTECH,IM 918564,OR,39.0,F,"Around 24 hours post COVID vaccination into her left delt, she woke up with severe left shoulder and neck muscle pain. She got in touch with her provider and was treated with valium and Celebrex. She reported about 2 cm swelling and fatigue. Thirty hours post vaccination, she had pain and swelling and could barely move. Dr. needed to take valium and Celebrex though for those 48 hours, and would have gone to the ER if they had not helped (the pain was that debilitating)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/17/2020,1.0,PVT,none except IUD,none,chronic dermatitis,,"amoxicillin, led to hives as a child","['Asthenia', 'Fatigue', 'Injection site pain', 'Mobility decreased', 'Neck pain', 'Pain', 'Swelling']",1,PFIZER\BIONTECH,IM 918565,NJ,59.0,F,"I developed a red, itchy rash at the injection site a FULL WEEK after the vaccination. I did not seek treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/27/2020,01/04/2021,8.0,PVT,None,None,None,,None,"['Injection site reaction', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 918566,NJ,29.0,M,"Fatigue, Myalgia, Fever - Began in the morning. Fever was relieved with 1000mg Acetamenophen. By the evening, I was started to feel relief from my symptoms. By the next day, I had complete resolution of my symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,PVT,Calcipotriene and Steroids for Psoriasis,None,Psoriasis,,None,"['Fatigue', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 918567,MD,38.0,F,"rash 1 week later, took Benadryl and is recovering",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,"vitamin d , c , culturelle",none,na,,"tree nuts , peanuts, bees",['Rash'],1,MODERNA,IM 918568,AZ,28.0,F,"36 hours after vaccine my face started swelling rapidly. I had extreme swelling and hardening in the areas where I have HA fillers - lips and tear troughs. Both Restylane products. Ended up going to the ER at 2 AM and receiving angioedema/anaphylaxis protocol. IV benedryl, famotidine, and solumedrol. Was put on prednisone and hydroxyzine for at home care for the next 3 days after event. Swelling went down by the next afternoon.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,"Xolair injections, Zyrtec, Singulair, BCP, Tumeric, Magnesium, MTV, Calcium, Zinc, Vit D3",Ganglion cyst surgery on 12/09/20,Chronic Idiopathic Urticaria and Asthma,,None,"['Induration', 'Lip swelling', 'Swelling face']",1,PFIZER\BIONTECH,IM 918569,CA,42.0,F,"Within 12 hours developed a sore arm at site of injection, by 24 hours had worsening soreness, difficulty raising arm. Improved at 72 hours and resolved at 96.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,PVT,None,None,None,,None,"['Injected limb mobility decreased', 'Injection site pain']",1,MODERNA,IM 918570,IN,31.0,F,"Started with hot flashes , light headed, partial facial numbness on the ride side. Light heart problems",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,None,None,None,,None,"['Cardiac disorder', 'Dizziness', 'Hot flush', 'Hypoaesthesia']",1,PFIZER\BIONTECH,IM 918571,AR,55.0,F,This report is only in response to the request from the Department of Health to submit all patients into VAERS that received the COVID19 vaccine and subsequently tested positive for COVID19. No other adverse reactions to the vaccine were reported. This patient received the vaccine on 12/16/20 and tested positive for COVID19 on 12/29/20.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/16/2020,12/29/2020,13.0,PVT,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 918572,IL,31.0,F,"Moderna COVID-19 Vaccine EUA Vaccinated Thursday 12/31/20 at 12:30pm Friday1/1/21 7:00AM- Nausea, fever 99.6-101.6, body aches, chills, fatigue, painful to use left arm, headache, racing heart beat, shortness of breath. Persisted all day. Saturday 1/2/21 8:00AM-fatigue, headache, muscle pain in left arm. Sunday 1/3/21 felt pretty normal all day, some fatigue, slight headache. Monday 1/4/21 5:00AM- nausea, shortness of breath, racing heart beat, fever 99.8, fatigue, headache. Monday 1/4/21 10:00AM- COVID test- negative",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,None,None,Chiari Malformation,,None,"['Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Palpitations', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 918573,TN,71.0,F,"injection site red 3in in length warm, itchy, hot flashes - some sweating",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/02/2021,10.0,OTH,"Duloxetine 60mg, Coq-10 100mg, Zinc 50mg, Pantoprazole 40mg, Levothyroxine 88mg, Propranolol 20mg, lisinopril 20mg",,"copd, stage 3 kidney disease, obese","2nd dose Shingrix , 2019, fatigue and sickness for 1 day",,"['Hot flush', 'Hyperhidrosis', 'Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 918574,TX,31.0,F,Immediately I got nauseas and headache. Next day my whole lower back was spasm and had horrible body pain/back pain. I almost passed out putting pants on. A friend took me to an Urgent care they gave me Shot of tramadol and given Tylenol 3. They also did a test on my kidney. About 50 hours after the shot I was feeling better.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,WRK,Multivitiamin Fish oils Biotin Pro-biotic Birth control,,Back issues,,Ceclor,"['Back pain', 'Depressed level of consciousness', 'Headache', 'Immediate post-injection reaction', 'Muscle spasms', 'Nausea', 'Pain', 'Urine analysis']",UNK,PFIZER\BIONTECH,SYR 918575,CO,65.0,F,"Nausea, lightheaded, dizzy, weak, itchy face, lower lip swollen. Taken to ER. IV started, given Benadryl, Pepcid, steroid IV, Oxygen. Watched for 2 hours, then discharged with resolution of symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Breo inhaler every morning; Albuterol inhaler prn; DuoNeb prn; Loratadine daily; Losartan daily; Aspirin 81 mg daily; Pantoprazole BID; Metformin 500 mg BID; Escitalopram 10 mg daily; OTC vitamins and minerals,No,"Asthma, Diabetes, Hypertension, Barrett's esophagus, Hyperlipidemia, Periodic depression",,"Tramadol (projectile vomiting), Oxycodone and Hydrocodone (severe hives) ;Phenothiazine (convulsions) ; Penicillin (hives); Unknow food allergy (spice?) (tongue swelling); EpiPen","['Asthenia', 'Dizziness', 'Electrocardiogram', 'Lip swelling', 'Nausea', 'Pruritus']",1,MODERNA,IM 918576,IL,26.0,M,"8 days after vaccination, i began to have hives over most of my body, starting 8:00am on 1/2/2021. On 1/3/2021, i went to a walk in and was prescribed prednisone which seemed to make it go away pretty quickly.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/25/2020,01/02/2021,8.0,PVT,"Vitamin D 50mcg, sertraline 100mg, and a multivitamin.",None,"asthma, sleep apnea",,"sulfa, differin, and adhesive tapes",['Urticaria'],1,PFIZER\BIONTECH,IM 918577,AZ,55.0,M,"I have concerns the actual injection was not even administered. There was no feeling of an injection at the time of administration, no discomfort, no normal pin prick of an injection, no ""blood dot"" on the bandage, no indication at the supposed injection site, no afterward discomfort of any kind, and the young girl was so nervous she dropped the retractable syringe into my vehicle at the time of the supposed injection. How do I confirm the injection was actually made!?",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PUB,,None,,,None,['Unevaluable event'],1,PFIZER\BIONTECH,IM 918578,NY,35.0,F,"Patient came in with redness and slightly raised with a size of the palm that started with a size of a coin. And slightly warm, but not itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/03/2021,4.0,PVT,,,,Pertussis Vaccine- fever,"amoxicillin, pertussis vaccine","['Erythema', 'Skin warm', 'Swelling']",1,MODERNA,IM 918579,WA,47.0,F,"12/23 within 2 mins after the vaccine I felt light headed and I felt like I was going to pass out my heart was beating really hard, it started to mellow out and my face swelled up about an hour after. I was told to go to the ER and I took oral Benadryl and it went away and did not return",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,no,no,no,,nuts and soy,"['Depressed level of consciousness', 'Dizziness', 'Palpitations', 'Swelling face']",1,PFIZER\BIONTECH,SYR 918580,WI,52.0,F,"headache, right sided neck pain, muscle tightness, dizziness that worsened when took maxalt. Had unusual response of dizziness and nausea after taking maxalt.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Dizziness', 'Headache', 'Muscle tightness', 'Neck pain']",1,MODERNA,IM 918581,NJ,62.0,F,"Arm was sore for about three days. On 12/21 evening, had headache, some lightheadedness and severe back muscle ache. On 12/22, had stomach upset, extreme fatigue, nasal congestion. On 12/24, had diarrhea. Fatigue continued until at least 12/29.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/18/2020,0.0,PVT,,,,,,"['Abdominal discomfort', 'Back pain', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Nasal congestion', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 918582,CO,49.0,F,"I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around the vaccine site. The next morning I had swelling of my hands, feet and legs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,UNK,I take synthroid and Norabe birth control.,No,I have hypothyroidism,,I am allergic to narcodics,"['Cough', 'Flushing', 'Injection site erythema', 'Lip swelling', 'Peripheral swelling', 'Vaccination site swelling']",1,PFIZER\BIONTECH,IM 918583,CA,47.0,F,Redness Swelling Itching All at the injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/27/2020,01/03/2021,7.0,UNK,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 918584,TX,38.0,F,"Day 0-2: Fever, chills, body aches, joint pain, headache, fatigue, pain at injection site Day 2-3: same as above but no fever (but felt feverish every so often; not consistent), new - sore throat, cough, stomach ache/light feeling of nausea Day 4-7: headache, fatigue, mild aches, sore throat, increased coughing, stomach ache/light feeling of nausea, some mild feelings of feverish, but no fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,Prenatal vitamins,none,none,,NKA,"['Abdominal pain upper', 'Arthralgia', 'Chills', 'Cough', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 918585,TX,43.0,F,First day I had muscle ache. Second day worst muscle pain on my left arm. Fourth Day at 9pm sever chest pain I took Ibuprofen to relive the pain the next morning I had to see the doctor because I had sever pain but not related to the heart .,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,SCH,Every Morning I'm taking Fish Oil B12 Lutein Ginkgo biloba Rifampin,,,,Season allergies,"['Chest pain', 'Myalgia']",UNK,PFIZER\BIONTECH,IM 918586,IN,51.0,F,numbness and tingling in shoulder worked up to back and front of head then to face and lips lymphnode swollen in armpit,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"synthroid, vit D",had covid in october,none--hypothyroidism,,none,"['Facial paralysis', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Lymphadenopathy', 'Paraesthesia', 'Paraesthesia oral']",1,MODERNA,IM 918587,MI,30.0,F,"Numbness, tingling, burning sensation of tongue. Diaphoresis and angioedema",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,None,None,None,,None,"['Angioedema', 'Hyperhidrosis', 'Hypoaesthesia oral', 'Paraesthesia oral', 'Tongue discomfort']",1,MODERNA,IM 918588,ME,30.0,F,"12 minutes after dose, feeling a little lightheaded and ""high"" like eating edibles. BP normal, no change with movement, no other associated symptoms. Resolved in 20 more minutes, released to self-monitor",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,famotidine,none,depression and anxiety,,no,"['Dizziness', 'Euphoric mood']",1,MODERNA,IM 918589,MO,63.0,F,"about 2:45 pm on 12/29/2020 I because extremely fatigue to the point I couldn't concentrate. I couldn't figure out why as I got proper sleep the night before so powered through until leaving work at 4 pm. When I got home I ate a small amount, I wasn't hungry and went to bed at 5 pm and slept through until 6 am. during the night I noticed my arm bothering me, itchy but didn't get up to check on it. When I woke this a.m. my arm had a big red bump, warm to the touch and itchy so now I'm convinced the fatigue was related to the COVID vaccine. I feel fine, I am not tired today but I am aware of my arm and it is itchy. I am surprised this happen a week later.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/29/2020,7.0,PVT,,,,,,"['Decreased appetite', 'Disturbance in attention', 'Erythema', 'Fatigue', 'Hypersomnia', 'Limb discomfort', 'Peripheral swelling', 'Pruritus', 'Skin warm', 'Sleep disorder']",1,MODERNA,IM 918590,MA,37.0,F,"Swollen lymph node in left upper inner arm. Site is swollen, red, warm, painful with approx. 1cm lump. Pain and swelling started Saturday AM 1/2/21, redness started that Saturday night.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,WRK,no,no,no,Swollen lymph node after Flu shot 2019 but only lasted 24-36hrs.,no,"['Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Lymphadenopathy']",UNK,MODERNA, 918591,MD,47.0,F,On the night of the vaccine she had increasing joint pain in knees and shoulders. Starting the next day she was having left lower rib area pain that was getting progressively worse. Left upper quadrant abdominal pain to palpation. Symptoms have improved but are still present.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Abdominal tenderness', 'Arthralgia', 'Injection site joint pain', 'Musculoskeletal chest pain']",1,PFIZER\BIONTECH,IM 918592,WY,71.0,F,"Public health nursing was conducting an outreach clinic. Client is an employee at the retirement center and received the Moderna vaccine via intramuscular injection to the left deltoid at approximately 0830. Client was instructed to wait 20 minutes before leaving. at approximately 0850 client came to nursing staff and reported hives to bilateral arms extending from elbow to wrist. No other hives present at that time. Client reported that they did not itch, and she only noticed them because she had looked down to get out of her chair. Client denied difficulty breathing or change to airway. Client reports that she ""gets hives for everything."" HR: 62, BP: 150/82, Respirations: 14. DON at the retirement center gave the client a dose of Benadryl and Zyrtec @ 0857. Client stated she felt fine and wished to return to her work duties. on 12/31/20 I called client to follow up and had to leave a voicemail. Client returned call while I was unavailable and left a message with the office secretary stating she was feeling fine, and had no more hives. Call placed to client on 1/4/21. Client did not answer.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,,,,,Latex,['Urticaria'],1,MODERNA,IM 918593,CA,37.0,F,"Patient reports regular stinging, then joint pain from shoulder down to fingertips and the swelling at the injection site and to the right there was one ""giant hive"". Patient also reports body aches and mild fatigue but she has recovered from that.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,Tylenol and Benadryl,,,,,"['Angioedema', 'Arthralgia', 'Fatigue', 'Injection site swelling', 'Pain']",UNK,MODERNA, 918594,NE,39.0,M,Approximately 30 minutes after the injection I felt myself get very flushed and slightly lightheaded. This feeling lasted for about 45 minutes before resolving. Had right shoulder pain start about 1-2 hours after the vaccine and it steadily increased to the point where it was too painful to move in certain ways that utilized that muscle. I had to assist my right arm with my left when needing to move it in certain ways between 12-36 hours after the vaccine was received. The pain dissipated to manageable levels after 48 hours post vaccination and resolved completely after about a week. Also experienced significant fatigue that started 3-4 hours after the vaccination. the first night after the vaccination I slept for 12 hours and the second night I slept for 10 hours. I was still able to go to work which does not involve too much labor and alot of computer work. Once home I did essentially nothing except rest on the couch or in bed. When I woke up on the third day the fatigue was mostly gone. It was completely resolved on the 4th day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,"Metoprolol BID, Lisinopril Daily, Clonazepam 4-5x week, Busperion Daily, Multivitamin 1-2x week",None,Unknown heart issue that causes intermittent High heart rates(170s). Full work up has failed to identify cause although metoprolol seems to keep it in check.,,Allergy to something in a laundry detergent. Caused full body rash. Unknown what specifically caused it. Otherwise no other allergies.,"['Dizziness', 'Fatigue', 'Flushing', 'Hypersomnia', 'Injected limb mobility decreased', 'Injection site pain', 'Pain']",1,PFIZER\BIONTECH,IM 918595,PA,32.0,F,"She had no immediate symptoms after vaccine but then presented to the Emergency Room and then approximate hour and a half later at 9:45 AM she noticed that she was having decreased sensation in her bilateral face left greater than right as well as on the ulnar aspect of her left arm (the side where she had the vaccine). During her time emergency department, the patient symptoms did improve and by the end of her ED stay she was reporting almost no residual sensation deficits.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,Multivitamin,no significant pas medication history,none,,no known allergies,"['Blood electrolytes normal', 'Magnetic resonance imaging brain normal', 'Paraesthesia', 'Pregnancy test urine negative', 'Urine analysis normal']",1,MODERNA,IM 918596,AR,57.0,M,This report is only in response to the request from the Department of Health to submit all patients into VAERS that received the COVID19 vaccine and subsequently tested positive for COVID19. No other adverse reactions to the vaccine were reported. This patient tested positive for COVID19 on 12/29/20 after receiving the vaccine on 12/16/2020.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/16/2020,12/29/2020,13.0,PVT,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 918597,NY,40.0,U,"Bell's Palsy system, left side of face and tongue numbness and tingling. primary care Dr. visited, prescribed Medrol( steroid), slightly numbness and tingling is better but it's still there and effecting daily life.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/23/2020,2.0,UNK,no,no,hypothyroidism,,no,"['Facial paralysis', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 918598,AR,25.0,F,"Around midnight I woke up and was extremely confused, felt like I had pretty bad cold, had some hives and started having some shortness of breath, that it kept waking me up. I also got nauseous. Almost threw up but did not. Took Benadryl and felt better. Had fever 100F in the morning, felt very fatigued next day. Went to work and the symptoms came back and they were intensified. I could barely walk. Took Benadryl and they decided to wheel me to the ER. I was unable to talk, I did not make sense. They gave me Benadryl and made me wait in the ER. I had tachycardia my pulse was fine. My BP was jumping around. I never had problems with that. At the ER they told me to take Benadryl and Pepcid for the next 3 days. My fever went down while I was at the ER. The next morning I checked it again and no more fever and I was feeling a lot better. I also had a slight headache, not bad. I called my PCP and they do not think it might be a good idea to receive the 2nd dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,"Adderall (as needed 5mg - not at the day of the vaccination) daily Vitamin, I carry an Epi pen.",No,IBS,"TDap - delayed reaction, about 2/3 years ago - high fever, shaky, felt really sick - not as bad as the COVID 19 one.","Very hypersensitive to many things. Aspirin, Penicillin and steroids.","['Blood pressure fluctuation', 'Confusional state', 'Dyspnoea', 'Fatigue', 'Gait disturbance', 'Headache', 'Nasopharyngitis', 'Nausea', 'Pyrexia', 'Sleep disorder', 'Speech disorder', 'Tachycardia', 'Urticaria']",1,PFIZER\BIONTECH,SYR 918599,CO,28.0,F,Pfizer-BioNTech COVID-19 Vaccine EUA experience a slight increased heart rate to about 101 2 min after injection and then another heart rate increase to 120 about 15 minutes after injection. Heart rate was back to normal about 5-10 after spike but patient stayed for observations for another 30 min.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,['Heart rate increased'],UNK,PFIZER\BIONTECH,SYR 918601,AZ,26.0,F,pt experienced blurred vision with dark spots and chest tightness Rph gave 1 diphenhydramine 25mg pt went home with husband,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,SEN,,,,,,"['Chest discomfort', 'Vision blurred', 'Visual impairment']",1,MODERNA,IM 918602,IL,38.0,M,Patient passed out. Blood pressure was low and pulse was low,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,unknown,unknown,unknown,,unknown,"['Heart rate decreased', 'Hypotension', 'Loss of consciousness']",1,MODERNA,IM 918603,NJ,41.0,F,Next day after the vaccine I felt very tired and my arm was very sore. The lymph nodes under my armpit and supraclavicular still swollen 11 days later and little painful.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,PVT,"Tylenol, Humira, Ibuprofen, Levothyroxine, vitamin B12, red yeast rice",none,Ankylosis Spondylitis PCOS Hypothyroid increased LDL,,now,"['Fatigue', 'Lymph node pain', 'Lymphadenopathy', 'Pain in extremity']",1,MODERNA,IM 918604,MD,31.0,F,I experienced a strong metallic taste approximately 2-5 minutes after receiving the vaccine that lasted about an hour.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,Multi-vitamin,Sinus infection one month prior to vaccination,None,,Ceclor-serum sickness. Bee venom-severe local swelling.,['Dysgeusia'],1,MODERNA,IM 918605,MA,69.0,F,"On 12-21-2020, after the injection patient states she did not feet well and her right index finger began to hurt right after. She states the right index finger pain started to hurt also on 12-23-2020. She states she will be receiving her second dose on Thursday 01-07-2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,WRK,"Synthroid 175mg, Anti-cholesterol, Preman 0.3mg",,,,,"['Malaise', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 918606,TN,45.0,F,"Patient received vaccine at 11:04. At 11:08 patient was checked on during rounds of monitoring for s/s of reaction and she stated that her hr feels like it was elevated, lips were tingling and the lower right part of her face was numb. Vitals were taken at this time BP was 110/68 HR 102. Patient was given Benadryl 50mg IM at this time x1 and monitored for 10 more minutes. Husband came and picked the patient up due to we told her she was unable to drive.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,none,none,none,,no known allergies,"['Heart rate increased', 'Hypoaesthesia', 'Impaired driving ability', 'Paraesthesia oral']",1,MODERNA,IM 918607,TN,42.0,F,"Within 5 minutes tongue began to go numb, a few minutes later cheeks and mouth went numb, heart rate was 115 white sitting down, blood pressure was 115/60 (typical blood pressure is 120/75), felt lightheaded and ""out of body."" Instructed to take Benadryl or have facility call an ambulance. Waited at site for nearly an hour for symptoms to improve, lightheadedness and out of body feeling improved, left site, took a 10 mg dose of liquid Benadryl at about 3:10, tongue and facial numbness went away about 4:30 pm same day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,OTH,nature throid - thyroid mediation progesterone/testosterone/estrogen creams multi vitamin fish oil magnesium adrenal support Zyrtec Flonase,None,Hashimoto's thyroiditis,,Sulfa allergy - anaphylaxis seasonal environmental allergies,"['Autoscopy', 'Dizziness', 'Hypoaesthesia', 'Hypoaesthesia oral']",1,MODERNA,IM 918608,OH,78.0,F,"""Pfizer-BioNTech COVID-19 Vaccine"" 12/29 patient developed SOB, fever tmax 103 degrees F, diaphoretic, dry heaves all started approximately 16 hours after vaccination given. patient then transferred to Hospital for further treatment and observation. 12/30 seen at injection site- erythema, swelling, warmth and tenderness Discharged back to home on 1/1 with RX for cephalexin to treat cellulitis of injection site",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,12/28/2020,12/29/2020,1.0,SEN,"OTC: vitamin D, cranberry caps, polycarbophil, senokot, duloxetine, estradiol VC, furosemide, metoprolol, mirabegron ER, rivaroxaban",none,"HTN, T2DM, dementia, Hx PE/DVT",,"codeine-N/V, darvan/sulfa drugs- no reaction documented","['Dyspnoea', 'Hyperhidrosis', 'Injection site cellulitis', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Pyrexia', 'Retching', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 918610,OK,43.0,F,"Redness, slight swelling, warm, and slight pain over 10 days after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,WRK,"Magnesium with zinc and D3, Probiotic, xyzal",none,none,,None,"['Erythema', 'Pain', 'Skin warm', 'Swelling']",1,MODERNA,IM 918611,WI,35.0,M,Patient received a dose of vaccine that may have been stored outside of refrigerated temperature for more than 12 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/02/2020,12/26/2020,24.0,PVT,,,,,,['Product storage error'],1,MODERNA,IM 918612,MO,47.0,F,"Injection site redness/warmth, have a knot and is itchy. Originally redness went away and now came back over a week later",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/29/2020,8.0,PVT,,,,,LATEX,"['Injection site erythema', 'Injection site nodule', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 918613,OH,50.0,F,"Severe Lumbar Pain, fever (highest 100.2), body aches, chills, rigors, headache, pain and soreness at vaccination site, decreased range of motion of left arm, tachycardia, tachypnea, chest pain, bilateral arm numbness and tingling into fingers, warm sensations shooting down upper legs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,"Probiotic, Vitamin D, Zinc, Tumeric, Multi-vitamin",NO,No,,NKA / NKDA,"['Back pain', 'Chest pain', 'Chills', 'Headache', 'Hot flush', 'Hypoaesthesia', 'Injected limb mobility decreased', 'Pain', 'Paraesthesia', 'Pyrexia', 'Tachycardia', 'Tachypnoea', 'Vaccination site pain']",1,MODERNA,IM 918614,PA,37.0,F,"5 minutes after the injection - felt a wave of tingling over upper body and itchy in back of throat. 10-15 minutes later, it happened again. Denies shortness of breath, some itchiness on tongue. Tongue was not swollen. Advised to take oral Benadryl. Total monitoring time = 40 minutes and was discharged/released home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,WRK,MIralax 17grams po daily,unknown,unknown,,Compazine,"['Paraesthesia', 'Throat irritation', 'Tongue pruritus']",1,PFIZER\BIONTECH,IM 918615,OK,40.0,F,LARGE KNOT AND HIVES AROUND INJECTION SITE. OCCURRED 5 DAYS POST INJECTION AND PROGRSSIVELY GOT WORSE THROUGHOUT THE NEXT 2 DAYS.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,PUB,"XYZAL, BENADRYL, FENNEL OIL, THIEVES OIL",,ULCERATIVE COLITIS,RASH FOLLOWING FLU VACCINES,"EGGS, LATEX, CARPET FIBERS, GRASS, SEASONAL","['Injection site nodule', 'Injection site urticaria']",1,MODERNA,IM 918616,ME,49.0,F,"Approximately 2 minutes after receiving the vaccine I felt flush, they way I describe it is the feeling you get when given IV contrast for an imaging study. My hands were sweating and I felt a menthol like smell that traveled down my throat. After about 5-10 minutes a headache started which lasted throughout the evening. I took a benadryl about 15 minutes after receiving the vaccine and the symptoms started to improve. No swelling, difficulty breathing or rashes noted.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,"Taken the morning of vaccination: Levothyroxine 175 mcg, Effexor 75mg, Prilosec 20mg, probiotic",None,Hypothyroidism,,"Polidocanol, sulfa drugs","['Flushing', 'Headache', 'Hyperhidrosis', 'Parosmia']",1,MODERNA,IM 918617,LA,39.0,F,"Fever 102, vertigo, sore throat, fatigue, nausea. Took Tylenol for fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/01/2021,1.0,PVT,"Omeprazole, Trintellix, Singulair, Flonase",,"Depression, GERD, allergies",,,"['Fatigue', 'Nausea', 'Oropharyngeal pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vertigo']",UNK,MODERNA,IM 918618,PA,23.0,F,"15 minutes after vaccine, patient c/o dizziness, nausea, tachycardia..",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Birth control; MVI,none,none,,"pseudoephedrine, shellfish","['Dizziness', 'Nausea', 'Tachycardia']",1,MODERNA,IM 918619,AR,51.0,F,This report is only in response to the request from the Department of Health to submit all patients into VAERS that received the COVID19 vaccine and subsequently tested positive for COVID19. No other adverse reactions to the vaccine were reported. The patient had a positive COVID19 test on 12/30/20.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/15/2020,12/30/2020,15.0,PVT,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 918620,WI,33.0,F,"Vaccination was at 8:15am. At 5:30pm, patient states she had a ""wierd sensation in my throat"", ""started having a difficult time breathing, and wheeze"". Patient states she felt like she couldn't breathe. By 6:00pm a cough started, at 9:30pm ""was completely congested"". At 6pm called provider friend who suggested patient ""use an Albuterol inhaler, Benadryl normal dose and take a hot shower"" and that is what she did. ""Breathing became easier after that"", cough persisted and was congested. The wheezing resolved that night, and breathing improved. The next day patient was congested, had a cough and the tops of her feet were ""extremely itchy"".",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,Birth Control medication - unknown med name Lasix - did not take that day,Cold in November.,SVT,,None,"['Cough', 'Dyspnoea', 'Oropharyngeal discomfort', 'Pruritus', 'Respiratory tract congestion', 'Wheezing']",1,MODERNA,IM 918621,FL,34.0,F,"I received the vaccine on December 29th, 2020. The vaccinated arm didn't really hurt until the next morning when I woke up I could barely move my arm. Around 10:00am I started getting chills and having sweats. Over the next hour I became severely fatigued even with taking my adderall that morning. My body started tingling, I felt dissociated, had a headache, and a little light headed. Almost a little drunk feeling. I went home from work and slept most of the day. When I woke up in the evening around 9pm I was sweaty, and my muscles and joints hurt. I took my temperature and it was 100.6. The next morning on December 31st I no longer had a fever. My temperature was 98. something. The next several days and even now I continue to feel severely fatigued, and slightly dissociated. However, each day I seem to feel the side effects a little less.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"Adderall, Zenpep, and Valacyclovir- as needed.",,Excessive Daytime Sleepiness.,,,"['Arthralgia', 'Body temperature increased', 'Chills', 'Dissociative disorder', 'Dizziness', 'Fatigue', 'Feeling drunk', 'Headache', 'Hyperhidrosis', 'Mobility decreased', 'Myalgia', 'Pain in extremity', 'Paraesthesia', 'Somnolence']",1,MODERNA,IM 918622,WI,26.0,M,"Systemic Hives, evaluated in Urgent Care and used Benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,no,,,['Urticaria'],UNK,PFIZER\BIONTECH, 918623,MI,31.0,F,I felt numbness and tingling in my lips and Right cheek that lasted for 1 hour. I received the vaccine on my Right upper arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"St. Johns Wort, daily multi-vitamin, magnesium",None,None,,None,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia', 'Paraesthesia oral']",UNK,MODERNA, 918624,MO,35.0,F,"Mild itching and throat itching/scratching Vital Signs 0829 - BP 142/92, HR 101, RR 20, Temp 98.8, SPO2 99% Vital Signs 0832 - HR 83, SPO2 98% Vital Signs 0850 - BP 120/80, HR 70, RR 18, Temp 97.6, SPO2 99% Benadryl administered at 0829 by RN",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Pruritus', 'Throat irritation']",1,MODERNA,IM 918625,OH,60.0,F,"Patient had a fever (highest was 102 degrees F), fatigue, muscle aches, and nausea that started on 12/30/2020 and ended 1/1/2021. She took ibuprofen for her fever with the last dose being on 1/1/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,,None,"GERD, silent reflux",,"Sulfa antibiotics, clindamycin, erythromycin","['Fatigue', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,IM 918626,IL,58.0,F,"12/26/2020 developed rash on back of neck and behind ears. She took cetirizine twice that day. 12/31/2020 developed hives on abdomen, back and thighs. She started diphenhydramine 1/2/2020 and rash still seemed to be worse",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/26/2020,5.0,PVT,Nothing,none,spinal stenosis carpal tunnel fibromyalgia dermatographia,,Dust misoprostol,"['Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 918627,NE,33.0,F,"by 3pm the next day after vaccine injection, my underarm started to hurt- by that night it started to swell and the pain continually got worse. I went to urgent care where I saw APRN who told me my lymph node had swollen as my lymph nodes were working at fighting off the vaccine.. swelling went down by Wednesday, 12/23/20 and pain gone by 12/25/20.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,"Zyrtec, Yaz birth control",none,none,,none that I'm aware of,"['Axillary pain', 'Lymphadenopathy', 'Oedema peripheral']",1,PFIZER\BIONTECH,IM 918628,AR,61.0,F,This report is only in response to the request from the Department of Health to submit all patients into VAERS that received the COVID19 vaccine and subsequently tested positive for COVID19. No other adverse reactions to the vaccine were reported. The patient tested positive for COVID19 on 12/30/2020,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/15/2020,12/30/2020,15.0,PVT,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 918629,,35.0,F,"Lightheadedness, tachycardia. Treated by supine positioning and water. Initial BP 145/70, 117/76 after resolution. HR 90",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Dizziness', 'Tachycardia']",1,MODERNA,SYR 918630,IL,40.0,F,"went to clinic with flu sx and headache . A covid test was done _Neg. my blood pressure was 148/103, then by end was 168/109 was told to go to er. in er my BP was 187/119. er Dr told me it was an immunity reaction to the Covid Vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,"Amlodipine Besylate 5 mg, vitamin c",0,"high blood pressure controlled by meds,",,Prozac family,"['Blood test normal', 'Chest X-ray', 'Headache', 'Influenza', 'Reaction to preservatives', 'SARS-CoV-2 test negative']",UNK,MODERNA,IM 918631,IL,35.0,F,Shortly after receiving the vaccine I broke out in a rash on my chest and torso. Over the next few weeks it has seemed to get worse covering more surface area. I contacted my Doctor to see what to do and if I should get the second dose.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/21/2020,4.0,PVT,Metformin Welbutrin Spirolactin Vitamin D,None,PCOS Sleep Apnea Anxiety,,None,['Rash'],1,PFIZER\BIONTECH,IM 918632,WI,26.0,M,"Systemic Hives, Evaluated in Urgent Care and was provided and recommended Benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Urticaria'],UNK,PFIZER\BIONTECH, 918634,TN,77.0,F,Patient woke up 1/3/21 with a sore mouth that burns and has skin peeling inside. Patient tried to do a hydrogen peroxide oral rinse that worsened the pain. Patient woke up at 2:00 am 1/4/21 with worsening pain and bigger rash inside of mouth.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PUB,"Ozempic, Amlodipine, Lasix, Omeprazole, Gabapentin, Clonazepam, Meclizine, Potassium Chloride, Latanoprost, Zofran",None; lap band removed 6 weeks ago,"Type II Diabetes Mellitus , Hypertension",,"Pencillin, Keflex, Codeine, Clindamycin","['Oral discomfort', 'Oral mucosal eruption', 'Oral pain', 'Skin exfoliation']",1,MODERNA,IM 918635,MD,49.0,M,"Patient felt like he was going to pass out after receiving the vaccine. He was monitored for 45 minutes, vital signs remained stable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,,['Dizziness'],1,PFIZER\BIONTECH, 918636,OK,29.0,M,Significant lymphadenopathy noted on left cervical nodes and clavicular nodes. First noticed about 10 days after vaccine given. Has persisted.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/27/2020,10.0,PVT,None,None,None,,None known,['Lymphadenopathy'],1,PFIZER\BIONTECH,IM 918637,VA,43.0,F,"Right sided jaw pain started 12/22/20 in the am progressed through the evening. When I woke up I had numbness and weakness in the right of my tongue which I quickly realized included the right portion of my face. Included tongue was numb and I couldn't move it. An Er trip and CT scan confirmed it was Bells Palsy. Today, My symptoms continue. Top of my head all the way to the way to bottom of neck is experiencing paralysis. Can move tongue now and it's partly numb but it's cooperating a bit more now. Nerve pain has worsened all over all the right side of face. Feels like someone has kicked face and I have a deep bruise. It's a deep ache. Nothing will take away the ache away. My eye doesn't lubricate like it should. So I have to either manually close it and wet it manually or tape it closed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/21/2020,3.0,PVT,Daily multivitamin,None,No,,Skin allergies - allergic to sunscreen,"['Computerised tomogram abnormal', 'Eye disorder', 'Facial paralysis', 'Facial paresis', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Neuralgia', 'Pain in jaw', 'Paralysis', 'Tongue movement disturbance']",1,PFIZER\BIONTECH,IM 918638,AR,45.0,M,"Patient tested positive for COVID-19. Symptoms include sinus congestion, partial anosmia, partial ageusia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/21/2020,5.0,PVT,Multivitamin Daily,None,None,,NKA,"['Ageusia', 'Anosmia', 'COVID-19', 'SARS-CoV-2 test positive', 'Sinus congestion']",1,PFIZER\BIONTECH,IM 918639,CA,57.0,F,"Numbs hands and feet, elevated blood pressure and tachycardia.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,multivitamin,none,none,,mango,"['Blood pressure increased', 'Full blood count', 'Hypoaesthesia', 'Metabolic function test', 'Tachycardia', 'Troponin']",1,PFIZER\BIONTECH,IM 918640,NY,59.0,M,temp of 102.4. that was about 11 hrs after the vaccine was administered. Took Tylenol and temp came down to normal and have not had a temp since. Nausea without any vomiting and poor appetite on and off 4 days. Very Tired and lethargy at times. Difficult time waking up would fall asleep at the drop of an hat. Extremely tired and sleepy. This lasted about 7 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,none,none at the time of vaccination. That night and up to 7 days after had reaction,"CHF, MI, Amyloidosis, DVT, Hyperlipidemia, HTN, Stem Cell Transplant, Thalasemia",,"All Statin, IV dye","['Body temperature increased', 'Decreased appetite', 'Fatigue', 'Lethargy', 'Nausea', 'Somnolence']",1,PFIZER\BIONTECH,IM 918641,MO,55.0,M,12-29-2020 1330- Shot administered Tasted lemon for 1 hour after shot Just slight soreness of injected arm 12-30-2020 0500 Woke up with fever of 100.7 Body aches Headache Congestion Slight dizziness Fever spiked to 101.5 during the day Very fatigued 12-31-2020 0500 Woke with fever of 100.5 Still had body aches and mild headache congestion and slight dizziness 12-31-2020 0800 fever gone 12-31-2020 0900 body aches gone headache gone dizziness gone 12-31-2020 1100 Headed back to work,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,PVT,,,,,PENICILLIN,"['Dizziness', 'Dysgeusia', 'Fatigue', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia', 'Respiratory tract congestion']",1,MODERNA,IM 918642,,56.0,F,"15 min after administration, patient reported dizziness and rapid heart rate. Symptoms passed quickly. 30 minutes post vaccination, HR 70-80, patient felt dizzy, jittery, light headed, and nauseated. First Responder called and patient transported to ED",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,WRK,,,,,,"['Dizziness', 'Feeling jittery', 'Heart rate increased', 'Nausea']",1,MODERNA,IM 918643,CA,64.0,F,Headache Body Chills Body aches Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,UNK,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pain']",1,MODERNA,SYR 918644,NC,65.0,M,"DEVELOPED INCREASED HYPERTENSION >20 POINTS HIGHER THAN NORMAL (185/115 ON 01.02.2021); GENERAL MALAISE, HEADACHE. TREATMENT NONE AS OF THIS DATE; OUTCOME; PENDING STILL ELEVATED BP AND HEADACHES",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/02/2021,9.0,WRK,TAMSULOSIN HCl - 0.4 MG PROPRANOLOL 80 MG HYDROCHLOROTHIAZIDE 25 MG,NONE,HYPERTENSION,,LISINOPRIL,"['Blood pressure increased', 'Condition aggravated', 'Headache', 'Hypertension', 'Malaise']",1,PFIZER\BIONTECH,IM 918645,OH,40.0,F,Chills the first day of injection and mild headache the next day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,"Birth control pill, Magnesium, Zoloft,",none,none,,Sulfur,"['Chills', 'Headache']",1,MODERNA,IM 918646,IL,24.0,F,Initial headache 30 min post vaccination and lasted for 1 hour. On 12/25/2020 tenderness noted in left armpit (lt injection arm). Tenderness persisted and worsened through 1/4/2021. On 1/4/2021 a lump was noted inferior lateral left neck. Ultrasound proved multiple enlarged lymph nodes in left axilla and left neck.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/25/2020,2.0,PVT,None.,None.,,,None.,"['Headache', 'Lymphadenopathy', 'Neck mass', 'Pain of skin', 'Ultrasound scan abnormal']",1,PFIZER\BIONTECH,IM 918647,FL,60.0,F,"Approximately 8 mins after injection, I began to experience lightheadedness and trouble focusing. Began to feel dizzy, weak, was sweating, and had a flushed appearance in face. On attempt to stand, felt like I could not take a step. In ER vitals were normal except for blood pressure was high. Was discharged after receiving IV fluids, lab tests, EKG. About 5 hours later, I developed a low grade fever of 99.7, blood pressure 142/92, chills, general malaise and body aches. Symptoms started dissipating later in the evening. Started feeling better as the day progressed the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Losartan potassium 50mg Amlodipine besylate 5mg Liothyronine SOD 5mcg Rosuvastatin calcium 40mg Vitamin D3 2000 IU Turmeric circumin 250mg,COVID positive (October 2020),High blood pressure Hypothyroidism Vitamin B12 deficiency,,Bactrim,"['Asthenia', 'Chills', 'Disturbance in attention', 'Dizziness', 'Electrocardiogram', 'Flushing', 'Gait inability', 'Hyperhidrosis', 'Hypertension', 'Malaise', 'Pain']",1,MODERNA,IM 918648,GA,38.0,F,"I began feeling tired around 2pm 24 hours after vaccination. I also had a head ache, fever and chills around 3-4pm fever was low grade stayed around 99.8 the following day which was the 23 of dec i had a headache all day and felt fatigued on the 24 i felt normal. My arm was sore VERY sore for about 4 days. I did test positive for covid on 11/2/2020 with moderate symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,none,none,none,,none,"['Chills', 'Fatigue', 'Headache', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 918650,NY,37.0,F,"Localized reaction That lasted about 3 days. Then a larger, red, warm and painful area return to week later and is spreading",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PVT,none,None,None,,Triptans,"['Erythema', 'Local reaction', 'Pain', 'Skin warm']",1,MODERNA,IM 918651,CA,50.0,F,Chills Headache Body Aches No fever,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/31/2020,9.0,UNK,,,,,,"['Chills', 'Headache', 'Pain']",1,PFIZER\BIONTECH,SYR 918652,SD,52.0,F,"erythema, induration, warmth to her right deltoid in the area of her injection. No other systemic symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/24/2020,1.0,OTH,"Cymbalta 30mg BID. Depakote 1000mg QD. Multivitamin 1 tab QD. Lactobacillus Acidophilus 1 tab QD. Biotin 5,000mcg QD. Joint Supplement 1 tab QD. Aleve 220mg PRN. Allegra 60mg PRN",None reported,"Anxiety, Afib, Cardiovascular disease, Depression, Environmental allergies, Frequent epistaxis, Glaucoma, Endometriosis, Migraines, Osteoarthritis, Peripheral Neuropathy.",,Lactose,"['Injection site erythema', 'Injection site induration', 'Injection site warmth']",1,MODERNA,IM 918653,MI,49.0,F,pain at injection site that radiated down left arm then turned into overall body aches on 1/3 at time of injection. Nausea started on 1/4 around 930am. overall fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,WRK,daily multi Vitamin flax seed oil metformin 500 mg statin- 40mg lisinopril 10mg iron supplement 325mg pepcid 40mg basaglar injection 30 units ozempic 1 unit once a week,"unwell in the beginning of December, no antibiotics needed",Diabetic type 2 high cholesterol high blood pressure,,cymbalta tessalon pearls surgical tape- adhesive,"['Fatigue', 'Injection site pain', 'Nausea', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 918654,AR,23.0,F,This report is only in response to the request from the agency to submit all patients into VAERS that received the COVID19 vaccine and subsequently tested positive for COVID19. No other adverse reactions to the vaccine were reported. The patient had a positive COVID19 test on 12/26/2020.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/26/2020,9.0,PVT,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 918655,NY,26.0,M,"After receiving the vaccine in the morning, patient developed eye swelling later on that evening, for which he took diphenhydramine 50 mg orally once. He felt better the next day, however the swelling came back the following day (12/24) in addition to eye itchiness. He was prescribed prednisone 60 mg orally daily for 5 days and diphenhydramine 50 mg q6h.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,None,None known,None,,NKDA,"['Eye pruritus', 'Eye swelling']",1,PFIZER\BIONTECH,IM 918656,MO,21.0,F,"Horrible migraine(unable to come in to work), dime size swelling at the injection site with difficulty moving that arm, nausea, diarrhea, fatigue and fever up to 100.2 for 2 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/29/2020,1.0,PVT,,,,,DOXYCYCLINE,"['Diarrhoea', 'Fatigue', 'Impaired work ability', 'Injected limb mobility decreased', 'Injection site swelling', 'Migraine', 'Nausea', 'Pyrexia']",1,MODERNA,IM 918657,VA,30.0,F,"12/29-- Chills, moderate arm soreness, malaise, fever 12/30-- fever 100.6 F, moderate to severe right arm soreness, nausea/vomiting, malaise 12/31- low grade fever (99.6 F), chills, mild soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PUB,Augmentin 500 mg BID for mild mastitis; Prenatal gummy vitamins QD; allergy shots (last shot between 20-30 days prior),Mild mastitis/superficial abscess started one week prior healthy breastfeeding,seasonal allergic rhinitis,,sulfa allergy-- rash-- baby,"['Chills', 'Malaise', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 918658,FL,46.0,F,"A few hours post vaccine, developed splotches and a scratchy throat. Took a Benadryl which resolved those symptoms. Wed, woke up with terrible headache, nausea and kidney pain, no other urinary symptoms or fever. Took Tylenol and Advil alternating between the two. Thursday, had kidney pain and diffuse joint pain. Friday, joint pain improved, still had kidney pain and do as of today, 4 Jan 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,MIL,Omeprazole,None,None,"3rd dose of Hep B vaccine, generalized hives, age 35","Demerol, Phenergan, Neosporin","['Arthralgia', 'Headache', 'Nausea', 'Rash macular', 'Renal pain', 'Throat irritation']",1,MODERNA,IM 918660,IL,27.0,M,"Myalgias in bilateral thighs, left shoulder, and right shoulder- Worst at 24 hours later. Headache-24 hours later. Poor thermoregulation with near vasovagal syncope while in the OR-24 hours later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,WRK,Adderall XR 20 mg,No,No,,No,"['Headache', 'Myalgia', 'Presyncope', 'Temperature regulation disorder']",1,MODERNA,IM 918661,NE,50.0,F,"rash & itching all over , face felt flush, fast heartbeat B/P 180/104 arm sore later that night & headache Given Benadryl 1 dose by employee health nurse then went to urgent care and received: 80mg Depo Medrol IM given in clinic. Start 40mg Prednisone daily for 3 days. Zyrtec 10mg daily as needed for itching. For your blood pressure, recommend taking medication and rechecking BP in 1-2 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,SEN,none,none,High Blood pressure,,"Sulfa, egg Allery","['Blood pressure increased', 'Flushing', 'Headache', 'Heart rate increased', 'Pain in extremity', 'Pruritus', 'Rash']",1,MODERNA,IM 918662,OH,35.0,F,Shaking and nervousness started 3 hours after vaccination. Vital signs stable: HR: 87 BP:121/87 O2:98,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,migraines,,Bactrim,"['Nervousness', 'Tremor']",1,MODERNA,IM 918663,CA,28.0,M,"Patient reports sore throat and runny nose, which has subsided. He also reports fatigue, which is mild, he states all symptoms have been mild.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/01/2021,2.0,PVT,,,,,,"['Fatigue', 'Oropharyngeal pain', 'Rhinorrhoea']",UNK,PFIZER\BIONTECH, 918664,ME,50.0,F,"initially first day to day 3 had sore arm, some hardness and swelling at site, all of that went away totally. 1/2/21 my left arm was fine, 1/3/21 at 2pm I had an itch and found to have significant hardness and red warm area at injection site about 1 3/4"" in diameter. I circled it and then 1/4/21 at 6am noticed the redness and swelling and hardness had increased by an inch. I contacted my doctor who diagnosed cellulitis and ordered oral antibiotics for 10 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2000,01/03/2021,7312.0,PVT,"flexeril, tramadol, cardiazem, breo ellipta, singular, nexium, Benadryl, trazadone, albuterol inhaler",no,"asthma, Ehlers Danlos Syndrome, tachycardia, GERD, inflammatory arthritis",,"no allergy to medications, allergic to cinnamon, tree nuts, eggplant. Allergic to dust mold, cats, all tree pollen all grass pollen, birch trees and blue grass are the worst,","['Cellulitis', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity', 'White blood cell count increased']",1,MODERNA,IM 918665,MO,33.0,F,C/o itching immediately following vaccine admin. Benadryl 50mg x 1 po admin per S.O.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,unknown,unknown,unknown,,Morphine,"['Immediate post-injection reaction', 'Pruritus']",1,PFIZER\BIONTECH,IM 918666,CA,,F,"Patient received the covid vaccine on 12/28/2020. con 12/29/2020 c/o new onset neck pain. She described it as ""shooting pain at the base of the neck"". No hx of neck pain or headache. Neck pain persists until 1/4/2021. Her PCP at the urgent care started her on Baclofen and gabapentin for pain controlled. Covid test on 12/29/2020 was negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,UNK,Lisinopril 2.5 mg po,,HTN,,Sulfa,"['Neck pain', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH, 918667,CO,43.0,F,"Injection site reactions: Pain, tenderness, swelling of the lymph nodes in the same arm as the injection General: fatigue, headache, muscle pain, joint pain, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"methyltrexate, birth control, lisinopril, multi vitamin, vitamin D, calcium",cold about 2 weeks prior,rheumatoid arthritis,I get the same symptoms reported here with the flu shot,erythromyacin,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Myalgia']",1,MODERNA,SYR 918668,MO,29.0,F,"Site of reaction started to itch day 2 to3 of vaccination, but I thought it was because my arm was still sore. I don't think I physically saw the rash until day 5ish...It is also around scar tissue so I don't know what /if it has anything to do with the reaction, I drew a border around the reaction on Friday (when I took the picture) and it is beginning to get smaller and look better.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/25/2020,3.0,PVT,,,,,,"['Injection site pruritus', 'Rash']",1,MODERNA,IM 918669,OK,59.0,F,"Beginning 4 a.m., extreme nausea, profusive sweating, severe body aches, head ache, muscles stiffness on right side of neck. No fever until 4 p.m. on 12/31/20. I have been tired sleeping most of 12/31, 1/1/21 and some on 1/2/21. Ran a fever 103. At that point I took ibuprofen. Fever subsided. I continue with some stiffness in right neck with a mild headache. No other known side effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,"Vitamin B12, B Complex, Vitamin C, Zinc, Turmeric, Biotin",none,Congenital Diastolic Heart Murmur,,Aspirin,"['Fatigue', 'Headache', 'Hyperhidrosis', 'Musculoskeletal stiffness', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 918670,TX,28.0,F,"Really strong left arm pain around injection site. Not able to extend or retract my arm for the day after injection. Was really painful, couldn't sleep or apply pressure to arm, also at one point I had an extremely sharp/shooting pain that was in my left arm/neck. Currently 5 months pregnant, due June 7th 2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,UNK,Doxylamine/pyridoxine,,,,,"['Injection site pain', 'Neck pain']",1,PFIZER\BIONTECH,SYR 918671,WY,44.0,F,"Fever (102.5 - 103.9), Pulse - 118, O2 - 94, Stabbing chest pain, Mediastinum tightness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,PVT,"Trazadone, Celexa, Hydroclorothiazide, Pot-Citrate, Melatonin","The hospital I work at did mandatory testing on Dec 21, 2020. I got my results back on Dec 23, 2020. My results were positive.",High blood pressure,,Season allergies,"['Chest discomfort', 'Chest pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 918672,FL,57.0,F,"Slight headache for about 20 minutes ,then developed to a full migrane. Took one Excedrin migrane pill at 12:05 pm( 01/04/2021). Migrane relieved slightly .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,None,Migrane,Migrane,,"Nuts, apples kiwifruit, pears,avocado","['Headache', 'Migraine']",1,MODERNA,IM 918673,,0.33,F,"Initial reaction sore arm, off balance, tingling in arm, around 2 hours later lower extremities painful - body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,SEN,"vitamin d3 50,000iu, vitamin b12 injection",,,,"Lipitor, statins, augmentin, clindamycin","['Balance disorder', 'Pain', 'Pain in extremity', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 918674,NY,52.0,M,"muscle aches and myalgia including soreness at injection site hours after vaccination. Next morning at 5 am, vertigo and dizziness, nausea and fatigue. Today- vertigo resolved. body aches and slight chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PVT,"vitamins, brilinta, metoprolol, crestor",no,coronary artery disease,,codeine/erythromycin,"['Chills', 'Dizziness', 'Fatigue', 'Injection site pain', 'Myalgia', 'Nausea', 'Pain', 'Vertigo']",UNK,MODERNA,IM 918675,UT,51.0,F,"Swollen, fat lips and swollen/tingling tongue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,levothyroxine 100 mcg Claritin Benadryl ibuprofen,none,Rt knee replacement 1.5 years ago.,,none,"['Lip swelling', 'Paraesthesia oral', 'Swollen tongue']",1,MODERNA,IM 918676,MN,45.0,M,"Aching joints and muscles, tingling feeling, pounding headache, sore are. Extreme tiredness. Missed two days of work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,,Had COVID-19 one month before.,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Pain in extremity', 'Paraesthesia']",1,MODERNA,IM 918677,MT,57.0,M,"Recipient described feeling dizzy with blurry vision. Vitals taken. All WNL, except blood pressure elevated to 142/90. He was escorted to wheel chair and remained with us for 15 minutes. He was still reporting blurry vision and some dizziness. Vital signs remained stable with approximately same elevated BP. He was taken to Emergency Department for observation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Unknown,None,Unknown,,Unknown,"['Blood pressure increased', 'Dizziness', 'Vision blurred']",1,MODERNA,IM 918678,TN,26.0,F,"Reddness, swelling, itching, warmth at injection site only",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PVT,lebatoalol 100mg daily,none,HTN,,none,"['Erythema', 'Injection site warmth', 'Pruritus', 'Swelling']",1,MODERNA,IM 918679,NH,41.0,F,"Approximately 5 minutes after her Pfizer vaccine, she felt like her throat was closing, flushed and became diaphoretic.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Unknown,None,Lupus,,None,"['Flushing', 'Hyperhidrosis', 'Throat tightness']",1,PFIZER\BIONTECH,IM 918680,NY,38.0,F,"For two days after injection the site of injection was very sore, painful at site which finally went away Friday night. I was woken up by a numbness, and tinging sensation in left side of face that continued all day Saturday, and into Sunday. I also experienced fatigue, itching, and a tingling rash sensation in several parts of body on, and off. On Monday morning I awoke without the facial numbness, and tingling sensations but i do have numbness and tingling in the right lower extremity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/02/2021,2.0,PVT,"Flonase, Zyrtec, azelastine, Xanax",,,,"coconut, and palm oil","['Fatigue', 'Hypoaesthesia', 'Injection site pain', 'Paraesthesia', 'Pruritus']",1,MODERNA,IM 918681,MO,32.0,M,"Syncopal event at home with LOC approximately 36 hours post vaccination with some fever and chills after. Unsure how long I was out, but estimated to be < 1 minute. All symptoms have resolved at this point.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/27/2020,12/29/2020,2.0,PVT,,,,,,"['Chills', 'Loss of consciousness', 'Pyrexia', 'Syncope']",1,MODERNA,IM 918682,CA,46.0,M,"I was coincidentally exposed to covid prior to the Covid vaccine so I don't think the symptoms were a result from the vaccine. 12/21/2020 I received the vaccine in the AM I started to have a low grade fever, body ache, malayse, next morning I woke up and had a higher degree fever body ache and increasing feeling of sickness. I got worse and contacted my own Dr and he let me know that I may have been exposed and I got tested and I was positive for Covid. I",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,PVT,none,no,no,,no,"['Malaise', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,SYR 918683,,0.5,F,Persistant symptoms of perception off and off-balance,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,SEN,,,,,,"['Balance disorder', 'Illusion']",1,PFIZER\BIONTECH,IM 918684,CA,40.0,F,"Fatigue, myalgias, arthralgias, headache, rhinorrhea, scratchy throat, chest tightness - approximately 72 hours duration",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,None,None,None,,None,"['Arthralgia', 'Chest discomfort', 'Fatigue', 'Headache', 'Myalgia', 'Rhinorrhoea', 'SARS-CoV-2 test negative', 'Throat irritation']",1,PFIZER\BIONTECH,IM 918685,MI,26.0,F,"increased (rapid) heartrate at rest, an hour following administration of vaccine. Symptom persisted for half an hour, followed by flushing of the face and slight nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,PVT,"Zyrtec, Fluticasone/salmeterol, Flonase, Sertraline, Norlyda, Daily multivitamin, calcium",,Mild asthma controlled by daily inhaler,,,"['Flushing', 'Heart rate increased', 'Nausea', 'SARS-CoV-2 antibody test negative', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 918686,TX,37.0,M,Left T7 herpes zoster,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,01/02/2021,15.0,PVT,Omeprazole 20 mg daily Trintilix 10 mg daily,None,Spastic diplegia Gerd MDD,,None,['Herpes zoster'],1,PFIZER\BIONTECH,IM 918687,NY,61.0,F,"Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, Itching all over body, scalp pain and tenderness. 12/28 Began feeling better, mild cough persists. 1/4: Feels as though she has ""bad flu"" fever of 101 F.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,12/24/2020,0.0,UNK,,,,,,"['Arthralgia', 'Cough', 'Diarrhoea', 'Influenza like illness', 'Nasal congestion', 'Oropharyngeal pain', 'Pain of skin', 'Pruritus', 'Pyrexia']",1,PFIZER\BIONTECH,IM 918688,ME,59.0,F,"From Saturday through Sunday pain developed up left arm, across latissimus and up neck. Severe pain in neck developed by Monday morning so that is was difficult to get out of bed due to neck pain. Pain only on left side of neck. No head ache, no rash or redness, Limited range of motion. Cannot put right ear on shoulder or chin on chest. Seen by doctor on duty in vaccine clinic. Taking ibuprofen and self monitoring. Reported symptoms to employee health.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/01/2021,4.0,WRK,"atovastatin, B12, folic acid, hair,skin, & nails, escitalopram, temazepam, progesterone, estrodiol patch, flexeril,",none,hypercholesterolemia - controlled with medication depression - controlled with medication,,nka,"['Back pain', 'Joint range of motion decreased', 'Mobility decreased', 'Neck pain', 'Pain in extremity']",1,MODERNA,IM 918689,MD,43.0,M,Severe neck pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/01/2021,4.0,PVT,"nexium, loratadine",none,,,none,['Neck pain'],1,MODERNA, 918690,TX,30.0,F,"On 12/23 around 2pm exp chills, higher temp than normal. My heart rate and BP was higher than normal lasted about a hour. I had to miss a day and 1/2 of work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,Prenatal Vit with iron,Infection,,,Allergic reaction to bee sting(EpiPen was prescribed not used),"['Blood test', 'Body temperature increased', 'Chills', 'Heart rate increased', 'Hypertension', 'Impaired work ability']",1,PFIZER\BIONTECH,IM 918691,,0.58,M,tingling in left fingers,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,SEN,"janument, lisinprol",,,,"peaches, mangos",['Paraesthesia'],1,PFIZER\BIONTECH, 918692,MO,50.0,F,"AT 5pm the same day, felt a little fatigued and slight headache. The next morning 12-30-20 at 730, was so fatigued, couldn't hardly stand. Felt like when I had mono. Had headache, back and neck aches, fever of 100.2. Felt like glands were swollen. After 4 hours, symptoms began to subside, but still mildly present. Fever subsided and was gone from 11AM on. Injection site pain still present with redness. Skin felt very sensitive on the arms Today, 12-31, felt good, no fever, slightly tired, but good enough to work. Came to work and when in the process of writing this RL, I was reviewing the side effects and looked at my injection site. It looked red so I asked a coworker, who thought it looked like hives. We had our medical director and PA look at it and although they didn't feel like it looked like hives, I developed hives on my chest, neck and chin while they were in here. Called employee health who recommended either PCP or urgent care. Went to urgent care. During visit, hives began to subside, had 99.6 fever at the beginning of the visit, 98.7 at the end of the visit. Rapid COVID test was negative. Received inhaler for asthma and returned to work at 1245 today.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,PVT,,,,,"ASTHMA TRIGGERED BY CEDAR, HAY, DUST, COLOGNES","['Back pain', 'Dysstasia', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Lymphadenopathy', 'Neck pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Sensitive skin', 'Urticaria']",1,MODERNA,IM 918730,,,M,"soreness around the flu shot injection site; This case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in a 41-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis. In November 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than 2 months after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent 2020-2021 season. Additional details were provided as follows: The age at vaccination was not reported. The patient had flu shot and he had soreness around the flu shot injection site and it lasted for few days, and it was better now.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,11/01/2020,,,UNK,,,,,,['Injection site pain'],UNK,UNKNOWN MANUFACTURER, 918739,MI,39.0,F,"Tingling in lower legs- neuropathy like; Fever 102.9; Tingling in lower legs- neuropathy like; Severe cramping in hands and feet; Severe bone pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the first dose of bnt162b2 (COVID-19 vaccine) lot no: EL0140, via an unspecified route of administration in left arm on 18Dec2020 15:15 at a single dose for COVID-19 immunization. Medical history included acid reflux and known allergies to PCN, both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of report. Concomitant medication included omeprazole (PROTONIX), ibuprofen (MOTRIN). No other vaccines were administered in four weeks. On 19Dec2020 at 14:30, the patient experienced fever 102.9 ""normal for vaccines i know"", tingling in lower legs neuropathy like, severe cramping in hands and feet, and severe bone pain. The patient recovered from the events in Dec2020. The patient did not receive treatment for the events. The events were reported as non-serious. The patient didn't have COVID prior to vaccination and was not tested post vaccination.; Sender's Comments: A possible causal association between administration of bnt162b2 and the onset of neuropathy like cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PUB,PROTONIX [OMEPRAZOLE]; MOTRIN [IBUPROFEN],,Medical History/Concurrent Conditions: Acid reflux (esophageal); Penicillin allergy,,,"['Bone pain', 'Muscle spasms', 'Neuropathy peripheral', 'Paraesthesia', 'Pyrexia']",1,PFIZER\BIONTECH, 918740,,36.0,U,"Scratchy throat; itching lips; This is a spontaneous report from a non-contactable nurse. A 36-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EK5730, via an unspecified route of administration on Right arm from 22Dec2020 to 22Dec2020 as single dose for COVID-19 immunization. Medical history included food allergy (Shrimp). The patient's concomitant medications were not reported. The patient experienced scratchy throat and itching lips for approximately 1.5 hours starting 20 mins post vaccine on 22Dec2020. The event caused prolonged hospitalization. The outcome of the events was recovered on 22Dec2020. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 vaccine cannot be excluded for reported events throat irritation and lip itching. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/22/2020,12/22/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Food allergy (known allergies: Shrimp),,,"['Lip pruritus', 'Throat irritation']",1,PFIZER\BIONTECH, 918741,SC,74.0,M,"delirious; hypoxic; fever; ataxic; incontinent; confused; Chills; HA; anorexia/had no appetite; myalgias; extreme fatigue; slept all and had no appetite; This is a spontaneous report from a contactable physician. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Dec2020 16:00 at single dose for COVID-19 immunization. Medical history included diabetes mellitus (DM). The patient has no known allergies. The patient's concomitant medications were not reported. He was an ER doctor and the medical director of his hospital. The patient was asymptomatic when he got the vaccine on 15Dec2020. 3 hours after the vaccine he began to get chills, HA, anorexia, myalgias, and extreme fatigue. This worsened and he slept all and had no appetite. On 19Dec2020 he woke up delirious with a fever and was ataxic, hypoxic, incontinent, and confused. The patient was hospitalized due to the events on 15Dec2020. The events also caused prolonged hospitalization due to the events. The patient was not diagnosed with COVID prior to vaccination. The patient was tested for COVID via nasal swab post vaccination with unknown results. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events as the patient required oxygen, plasma, and remdisivir. The batch/lot numbers for the vaccine, BNT162B2, were not provided and will be requested during follow up.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of reported serious events might not be excluded, considering the plausible temporal relationship. Fever, chills, headache, fatigue and muscle pain are the known adverse event profile of the suspect product. More information such as detailed underlying medical conditions and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/15/2020,12/15/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Diabetes mellitus,,,"['Ataxia', 'Chills', 'Confusional state', 'Decreased appetite', 'Delirium', 'Fatigue', 'Headache', 'Hypoxia', 'Incontinence', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 918742,TN,38.0,F,"Allergic reaction; Diarrhea; Chills; Palpitation; Tongue and throat swelling; Tongue and throat swelling; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ELO141), via an unspecified route of administration on 21Dec2020 at a single dose for covid-19 immunization. The patient's medical history included asthma and allergy. Concomitant medication included levosalbutamol hydrochloride (XOPENEX) for asthma and cetirizine hydrochloride (ZYRTEC) for allergy. About hour and a half to two hours after the vaccine, on 21Dec2020, the patient experienced had an allergic reaction with symptoms set of diarrhea, chills, palpitations, and tongue and throat swelling. The patient took diphenhydramine (BENADRYL) 25 mg as treatment. It helped some. She woke up this morning (22Dec2020) and still had the symptoms. So, she went to the emergency room. They gave her diphenhydramine 25 mg IV, methylprednisolone (SOLUMEDROL), and famotidine (PEPCID). The patient underwent lab tests and procedures which included blood count and chemistry and lab work which showed normal on 22Dec2020. Outcome of the events was unknown. The patient thinks that the product had causality to the events. Information on the lot/batch number has been requested.; Sender's Comments: The patient's medical history included asthma and allergy. Based on information available, the reported allergic reaction with symptoms set of diarrhea, chills, palpitations, and tongue and throat swelling was likely related to the use of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/21/2020,0.0,UNK,XOPENEX; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Allergy; Asthma,,,"['Blood count normal', 'Chills', 'Diarrhoea', 'Hypersensitivity', 'Laboratory test normal', 'Palpitations', 'Pharyngeal swelling', 'Swollen tongue']",UNK,PFIZER\BIONTECH, 918743,VA,32.0,F,"shaking uncontrollably/she was full of shakes to the point the bed was shaking; chills; Woke up in the middle of the night; body aches; as painful as a strep infection; sore throat that was as painful as a strep infection/throat feels sore to the point of Strep/Throat soreness: Felt like sharp razor blades; Feels like she is having an extreme immune response; Feels congestion; severe serum sickness/weird serum sickness; high fever/Had a fever over 101; This is a spontaneous report from a contactable nurse(patient). A 32-year-old female patient received BNT162B2(lot number EH9899) via an unspecified route of administration at Arm Left on 21Dec2020 (from 16:30 to 17:00) at the age of 32 years old at single dose for doesn't want to bring COVID home to her family. The medical history included Migraine headaches. The concomitant medications were not reported. The patient had so many immunizations for international travel, had Yellow Fever vaccine, all of the Guardasil vaccines, had MMR vaccine four times because she never developed immunity to it until the fourth round, got a flu shot yearly,got TDap vaccine every five years because she was an HCP, did Emgality shots( not done it this month. Emgality had a protein inhibitor, was supposed to get Emgality shot on 21Dec2020). On 22Dec2020 the patient experienced severe serum sickness, high fever, body aches to the point that she was shaking uncontrollably, sore throat that was as painful as a strep infection; Caller mentioned she was taking tylenl and benadryl for her symptoms. The patient was a Nurse Midwife. She got the vaccine on Monday evening at 4:30PM. Feeling like she was having a weird serum sickness. Woke up in the middle of the night and she was full of shakes to the point the bed was shaking. She had a fever over 101. Felt like she was having an extreme immune response. She was taking Tylenol and Benadryl around the clock. Woke up this morning and her throat feels sore to the point of Strep. Wondering if she need to distance and get some kind of test. Has been wearing a mask all of the time and doesn't know of anyone people who have COVID that she has been in contact with. Feels congestion and sore throat. Shakes and chills: Began at 02:30. Hard core chills and shakes. High fever over 101: same time as chills and shakes. Woke up from a dead sleep. Didn't have a working thermometer but knows her temperature must have been over 101 by the way she felt. She didn't feel that crappy unless her fever is over 101. She can gauge her own temperature. She experienced throat soreness: Felt like sharp razor blades. The patient was taking numbing throat lozenges. Seriousness: Would say serious. Didn't require hospitalization. She self-treated. Had she not had to work, she would probably have stayed in bed. Has been taking round the clock medicine. The outcome of the events was unknown. The information on the batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported serious events including severe serum sickness, high fever, body aches, shaking uncontrollably, sore throat that was as painful as a strep infection, feels like having an extreme immune response, congestion, chills, woke up from a dead sleep and the administration of the COVID 19 immunization with BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to those, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/22/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Migraine headache,,,"['Chills', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'Respiratory tract congestion', 'Serum sickness', 'Sleep disorder', 'Tremor']",UNK,PFIZER\BIONTECH, 918744,KS,38.0,F,"Have a fever with a high of 99.6 Fahrenheit; felt winded like she has exerted herself more than expected/shortness of air; Coughing/cough got worse; She is covid positive/Tested positive for COVID 19; She is covid positive/Tested positive for COVID 19; Shortness of breath/Shortness of breath was reported as worsened/feels winded; Tachycardia; Has been sick ever since; Felt like she was in a fog, on a cloud, heavy and out of it; She felt hot and weird but had no fever; Headache; Burning sensations in her legs; Extreme fatigue, want to go to bed; headache went away and she felt like the congestion was clearing up some; Arm was sore; This is a spontaneous report from a contactable ICU nurse (patient [Registered nurse ADN]) via Pfizer-sponsored program. A 38-year-old female patient received single dose of BNT162B2 (lot number: EK5730) , via an unspecified route of administration (right arm) on 16Dec2020 20:30 for immunization (for front line health care worker). Medical history included allergies; acid reflux; patent foramen ovale (PFO); supraventricular tachycardia (SVT) without treatment, vitamin D low and ongoing smoker. The patient had no other history/family history. Concomitant medication included loratadine (CLARITIN) taken for at least 5 years for allergy, famotidine from Dec2020 for acid reflex, and vitamin D taken for 5 or more years for vitamin D low; all given orally and were ongoing. The patient had no other prior vaccines within 4 weeks of Covid vaccination. Patient had been taking Covid tests on and off due to her immunocompromised daughter. On 15Dec2020 she took the PTR that took three to four days for results; she tested negative for Covid and was completely asymptomatic. She then received the COVID 19 vaccine 16Dec2020. Her test was positive for COVID 19 on 18Dec2020 and she had been sick ever since. She received the vaccine at the hospital where she works. The vaccine was not administered at facility. She further reported she was fine after getting the COVID 19 vaccine. Her right arm was sore/ started to hurt about four or five hours later on 16Dec2020 but then was fully after 24 to 48 hours. She started to feel sick on 18Dec2020 (Friday evening). States she went to bed Friday morning after the night shift. She felt fine, better than normal. That same day (18Dec2020) she woke up at 1700 and felt like she was in a fog, on a cloud, heavy and out of it. She walked around for a while and that sensation didn't go away. She felt hot and weird but had no fever. Then at 1830 she got the alert on her phone that told her she was positive for COVID 19. She started to feel other symptoms on 18Dec2020 including headache, shortness of breath, tachycardia, burning sensations in her legs; extreme fatigue, wanting to go to bed that persisted from Friday to Sunday. Then on 20Dec2020, Sunday afternoon, her headache went away and she felt like the congestion was clearing up some. Mentions she did have a fever (onset date unspecified) with a high of 99.6 Fahrenheit; but it went back down to 99.0 Fahrenheit (date/s unspecified). On 20Dec2020 the patient experienced coughing. On 21Dec2020 (Monday) she started coughing more but states her O2 was fine and her breathing was okay. However, when walking around she felt winded like she has exerted herself more than expected. She then clarified that on 21Dec2020, she experienced shortness of air and the cough got worse but it has now plateaued. She did call her HCP and they were holding off on treatment at the time. No investigation assessment was performed. The patient was not admitted to an Intensive Care Unit. The patient did not display clinical signs at rest indicative of severe systemic illness nor did she require supplemental oxygen or receive mechanical ventilation. No preexisting diseases worsened during the SARS-CoV2 infection. The patient considered shortness of breath, and tachycardia as serious: medically significant while the events headache, burning sensations in her legs, fatigue, Coughing, and feels winded were considered as not serious. The events headache, shortness of breath, tachycardia, burning sensations in her legs, fatigue, Coughing, and feels winded were ongoing at the time of reporting. Shortness of breath worsened. The patient recovered from arm was sore on an unspecified date in Dec2020; and was recovering from tachycardia, sick, headache and congestion. The outcome of felt like she was in a fog, on a cloud, heavy and out of it; felt hot, and fever was unknown while not recovered for the other events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/16/2020,0.0,PVT,CLARITIN [LORATADINE]; ; VIT D,"Smoker (Is the patient a smoker/former smoker? Yes, current.)",Medical History/Concurrent Conditions: Acid reflux (oesophageal) (allergies; acid reflux; PFO; SVT without treatment); Allergy (allergies; acid reflux; PFO; SVT without treatment); Foramen ovale patent (allergies; acid reflux; PFO; SVT without treatment); Supraventricular tachycardia (allergies; acid reflux; PFO; SVT without treatment); Vitamin D low,,,"['Burning sensation', 'COVID-19', 'Cough', 'Discomfort', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Feeling hot', 'Headache', 'Malaise', 'Pain in extremity', 'Pyrexia', 'Respiratory tract congestion', 'SARS-CoV-2 test positive', 'Tachycardia']",1,PFIZER\BIONTECH, 918745,AL,33.0,F,"General weakness requiring assistance to stand.; General weakness requiring assistance to stand; Rash on chest/neck; This is a spontaneous report from a contactable Pharmacist. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), intramuscularly on 22Dec2020 13:15 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. None medical history. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient experienced rash on chest/neck. General weakness requiring assistance to stand on 22Dec2020 17:00 with outcome of recovered in Dec2020. The date report was first received from source was 23Dec2020. Patient received Fluid bolus, IV benadryl, IV steroid as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The events were reported as non-serious.; Sender's Comments: The reported events rash on chest/neck and general weakness requiring assistance to stand were likely related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Dysstasia', 'Rash']",1,PFIZER\BIONTECH,OT 918747,IL,34.0,F,"Flushing; she noticed that there was a ringing in her left ear; Experienced a weird heaviness on her upper chest and arms/ heavy legs and arms/really heavy arms and legs; experienced a weird heaviness on her upper chest and arms; really cold hands; felt really hot at the injection site/really hot sensation at injection site; lightheadedness/Light-headed; Palpitations; Feeling faint; shortness of breath; Her blood pressure went up to 134/100; paleness; went up to her face; felt tired/She was really tired and slept it off; This is a spontaneous report from a contactable nurse, who is also the patient. This 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK5730) intramuscular in the left deltoid on 20Dec2020 at single dose for COVID-19 immunisation. Relevant medical history included ongoing asthma (diagnosed as a teenager with sports asthma and uses an inhaler). There were no concomitant medications. The patient experienced lightheadedness/light-headed (medically significant) on 20Dec2020 with outcome of recovering, palpitations (medically significant) on 20Dec2020 with outcome of recovered on 20Dec2020, feeling faint (medically significant) on 20Dec2020 with outcome of recovered on 22Dec2020, flushing (medically significant) on 21Dec2020 with outcome of recovered on 22Dec2020, she noticed that there was a ringing in her left ear (medically significant) on 21Dec2020 with outcome of recovering, shortness of breath (medically significant) on 20Dec2020 with outcome of recovering, her blood pressure went up to 134/100 (non-serious) on 20Dec2020 with outcome of recovered on 20Dec2020, she experienced a weird heaviness on her upper chest and arms (non-serious) on 21Dec2020 with outcome of recovering, really cold hands (non-serious) on 21Dec2020 with outcome of not recovered, paleness (non-serious) in Dec2020 with outcome of unknown, felt really hot at the injection site/really hot sensation at injection site (non-serious) on 21Dec2020 with outcome of recovered on 23Dec2020, went up to her face (feeling hot) (non-serious) in Dec2020 with outcome of unknown, heavy legs and arms/really heavy arms and legs (non-serious) on 21Dec2020 with outcome of not recovered and felt tired/she was really tired and slept it off (non-serious) in Dec2020 with outcome of unknown. The patient specified that she experienced a moderate reaction after having the COVID-19 vaccine. She had the vaccine last Sunday morning 20Dec2020. She was told to wait 20 minutes before leaving. In the waiting area, she felt lightheaded, had palpitations and was feeling faint. After 20 minutes she started feeling better. Then she started to have more intense light headedness. She went to the ER and was given oxygen. Her blood pressure was 134/100 on 20Dec2020. She had an EKG on 20Dec2020 that was normal. They gave her steroids and Benadryl. She had another episode while being injected with the steroids. On Monday 21Dec2020, she experienced a weird heaviness of her upper chest and arm. She had really cold hands and flushing. On Monday night 21Dec2020 she went to work. She experienced a really hot sensation to the injection site that went to her neck and face. Her left ear was ringing. This lasted until Tuesday 22Dec2020. She took Benadryl again on Tuesday 22Dec2020. She had shortness of breath which started on 20Dec2020 and on 22Dec2020 she had shortness of breath that lasted until 11am. She had really heavy legs and arms and went back to the ER. She had a chest X-ray and D-dimer on 22Dec2020 that were normal per the ER. The night before the report, she had some of the same symptoms. She was really tired and slept it off. She didn't take anything. The morning of the report, she was feeling good and better. She still has heavy feeling on upper chest and arms. Caller clarifies that she did not have a heavy feeling in her legs. Her arms feel heavy if she holds her phone too long. She continues to have ringing in her ear. The flushing went up to her face. The patient specified that she developed sports asthma as a child and uses an inhaler. She gets short of breath if she overexerts herself. Additional laboratory investigations on 20Dec2020 included blood work with unknown results and Troponin which was normal. She was provided with a general steroid. She did not know the name of it. She was also given Benadryl and monitored on telemetry. She was given IV fluids again on 22Dec2020.; Sender's Comments: Based on the compatible temporal association and the known pattern of response, the Company considers the reported events are possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/01/2020,,UNK,,Asthma (Diagnosed as a teenager with sports asthma and uses an inhaler.),,,,"['Blood pressure increased', 'Blood test', 'Cardiac telemetry', 'Chest X-ray normal', 'Chest discomfort', 'Dizziness', 'Dyspnoea', 'Electrocardiogram normal', 'Fatigue', 'Feeling hot', 'Fibrin D dimer normal', 'Flushing', 'Injection site warmth', 'Limb discomfort', 'Pallor', 'Palpitations', 'Peripheral coldness', 'Tinnitus', 'Troponin normal']",UNK,PFIZER\BIONTECH,OT 918748,,,U,"just kind of having blackout; Severe fatigue/fatigue; Severe myalgia; Some congestion; Severe headache; Haziness; This is a spontaneous report from a contactable other healthcare professional (HCP), who is also the patient. This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. In Dec2020, the patient experienced just kind of having blackout, severe fatigue, severe myalgia, some congestion, severe headache and haziness. On day six, symptoms improved and suddenly he/she was having symptoms again, severe myalgia, some congestion severe headaches and fatigue. The outcome of the events was unknown. The information about batch/lot number has been requested.; Sender's Comments: This report fails to include the basic information that is required for an independent medical evaluation. Assessment is postponed after receipt of a more complete case report. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Fatigue', 'Feeling abnormal', 'Headache', 'Loss of consciousness', 'Myalgia', 'Respiratory tract congestion']",UNK,PFIZER\BIONTECH, 918749,,,F,"Flu like symptoms like myalgia, achy head, mental cloudiness; Flu like symptoms like myalgia, achy head, mental cloudiness; Flu like symptoms like myalgia, achy head, mental cloudiness; Flu like symptoms like myalgia, achy head, mental cloudiness; Deep cough; This is a spontaneous report from a non-contactable physician. A female patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Dec2020, in left upper arm like deltoid, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Dec2020, immediately after receiving the vaccine, the patient experienced a deep cough which came on all of a sudden, followed 31 hours post vaccine by flu like symptoms like myalgias, achy head and mental cloudiness. She was feeling a bit better on 22Dec2020 morning and she was back at work. So, it was like a short couple of hours, maybe 24 hours turnaround. The events were resolving at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported flu like symptoms like myalgias, achy head and mental cloudiness and the administration of the COVID 19 vaccine BNT162B2 based on the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Cough', 'Feeling abnormal', 'Headache', 'Immediate post-injection reaction', 'Influenza like illness', 'Myalgia']",1,PFIZER\BIONTECH, 918750,,,U,"Urination bleeding; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (Solution for injection, lot number and expiration date not provided), via an unspecified route of administration at single dose on 22Dec2020 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced urination bleeding in Dec2020 and wanted to know if it was going to be a side effect. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/01/2020,,UNK,,,,,,['Blood urine present'],UNK,PFIZER\BIONTECH, 918751,CA,37.0,F,"severe fever; chills; severe night sweats; hives throughout my body; a rash on my face; This is a spontaneous report from a contactable nurse. This nurse reported for helf that the 37-year-old female patient received first dose of bnt162b2 (BNT162B2, product: COVID 19, brand: Pfizer), via an unspecified route of administration on Left Arm on 19Dec2020 10:30AM at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Known Allergies to medications, food, or other products:Cocoa butter. Concomitant medications were unknown. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that ""Starting seven hours after the vaccine, I experienced severe fever and chills. The next morning, despite multiple anti-pyretics, the fevers/chills were worse. Also I experienced severe night sweats, likely related to the fevers. Three days after the vaccine, I began to have hives throughout my body and a rash on my face. Responds to Benadryl, but eventually reappears."" The event started from 19Dec2020 05:30 PM. Treatment was received for the adverse event included Anti-pyretics, anti-inflammatories, anti-histamine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility type vaccine was hospital. No other vaccine in four weeks. The patient recovered with lasting effects. No Covid prior vaccination. No Covid tested post: vaccination. The outcome of the event was recovered/resolved with sequel in Dec2020. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The reported events severe fever and chills, severe night sweats, and hives and a rash on face were likely related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/19/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Food allergy,,,"['Chills', 'Night sweats', 'Pyrexia', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH, 918753,MA,28.0,F,"Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain. Started on Thursday 17Dec2020 at 7:45 pm; Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain. Started on Thursday 17Dec2020 at 7:45 pm; This is a spontaneous report from a contactable nurse reported for herself. A 28-year-old female patient (no pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in left arm on 16Dec2020 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced left sides shock like pains in head, lasted 3-5 seconds and went away. It's a stabbing shock like pain. The events started on Thursday 17Dec2020 at 19:45. It was unknown whether treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. The most recent COVID-19 vaccine was administered in hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association, the event left sides shock like pains in head is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/17/2020,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Headache', 'Paraesthesia']",1,PFIZER\BIONTECH,OT 918755,KS,58.0,F,"patient began to experience dizziness/shakiness.; patient began to experience dizziness/shakiness.; This is a spontaneous report from a non-contactable other hcp reporting for a patient. A 58-year-old female patient received first dose of BNT162B2 (Pfizer product, lot number: EH9899), intramuscular on 21Dec2020 16:00 at single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that during her 15 minute waiting period after the injection (21Dec2020 16:15), the patient began to experience dizziness/shakiness. This provider was notified of patient reaction and she was then transferred to the emergency bay via wheelchair where she was assessed. Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with dyspnea, increased work of breathing, persistent cough and cyanosis, vomiting, hypotension, dysrhythmia, chest pain and collapse. Treatment included no therapy, but did continue with vital checks at approximately 5 minute intervals. Patient discharge: stable to go home and follow up with PCP. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the compatible time association, the dizziness and shakiness are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/21/2020,0.0,UNK,,,,,,"['Dizziness', 'Tremor']",1,PFIZER\BIONTECH,OT 918758,NH,61.0,F,"Small bowel obstruction with diffuse bowel and pelvic lymphadenopathy 36 hours after injection; Small bowel obstruction with diffuse bowel and pelvic lymphadenopathy 36 hours after injection; This is a spontaneous report from a contactable physician (patient). A 61-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), intramuscularly on 21Dec2020 12:30 to at single dose on left arm for COVID-19 immunization in hospital. Medical history included crohn's disease. No known allergies. Concomitant medications within 2 weeks of vaccination included estradiol, progesterone, colestipol hydrochloride (COLESTID), ustekinumab (STELARA), cyanocobalamin (B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced small bowel obstruction with diffuse bowel and pelvic lymphadenopathy 36 hours after injection on 22Dec2020 22:00 with outcome of recovered in Dec2020. The adverse events resulted in emergency room/department or urgent care, hospitalization for 3 days. Therapeutic measures were taken as a result of event included inpatient observation, nothing by mouth (reported as NPO), intravenous fluids. No COVID prior vaccination, COVID test nasal swab was negative on 23Dec2020 post vaccination. It was not reported as serious.; Sender's Comments: There is not a reasonable possibility that reported events small bowel obstruction and lymphadenopathy are related to BNT162B2 vaccine. The patient had underlying Crohn's disease, which put patient at risk of developing the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,; ; COLESTID; STELARA; B12 [CYANOCOBALAMIN],,Medical History/Concurrent Conditions: Crohn's disease,,,"['Lymphadenopathy', 'SARS-CoV-2 test negative', 'Small intestinal obstruction']",1,PFIZER\BIONTECH,OT 918759,NC,35.0,F,"burst blood vessel in left eye/blood in her eye; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899, expiry date 01Mar2021), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. Vaccine location was left deltoid. The facility type vaccine was hospital. Medical history included ongoing rheumatoid arthritis for about 8 years. No known allergies. Patient didn't do relevant test. Concomitant medication included duloxetine hydrochloride (CYMBALTA) for rheumatoid arthritis for 2 years, sulfasalazine for rheumatoid arthritis for 4 months, it's unknown if they were ongoing. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the vaccine yesterday (23Dec2020), which she was very excited about, but today (24Dec2020) she woke up with a burst blood vessel in her left eye, she appears to have blood in her eye. This has never happened to her before. She knows this can occur with patients that have COVID but didn't know if it was a side effect to receiving the vaccine. Patient didn't receive treatment for the adverse event. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was not recovered. The relatedness between COVID vaccine and event ""burst blood vessel in left eye"" was related by reporter. Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities.; Sender's Comments: ""Burst blood vessel in eye"" is not uncommon in general population, and there are many causes of the event. Considering temporal relationship, a contribution role of the injection of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported Eye haemorrhage cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,CYMBALTA;,Rheumatoid arthritis (for about 8 years),,,,['Eye haemorrhage'],UNK,PFIZER\BIONTECH, 918760,FL,27.0,M,"Tachycardia; Intermittent palpitations; Low grade fever/fever; muscle aches; This is a spontaneous report from a contactable physician. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in unknown arm on 17Dec2020 at single dose for routine mass immunizations (covid-19 immunization). The COVID-19 vaccine was administered at Hospital. Not a military facility. The patient's medical history was reported as none and concomitant medications was none (he was on no other medications). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced tachycardia, intermittent palpitations, low grade fever/fever all started somewhere in the morning of 18Dec2020 and muscle aches on 17Dec2020. Physician assessed tachycardia and intermittent palpitations as serious due to medically significant. Physician stated that one of his workers had the vaccine and proceeded to have tachycardia and low grade fever. He would like to know if patient should get the second dose. The patient had mostly tachycardia with some intermittent palpitations. Patient was seen in his office on 18Dec2020, and got the COVID vaccine on 17Dec2020. He also reported fever and muscle aches, although the fever was subjective and was not documented. Tachycardia improved and sent him to cardiology on 21Dec2020. It was not life threatening and they did an Electrocardiogram (EKG). His initial heart rate was 130. When he was seen again in their office on 21Dec2020, it was 93, which was baseline. It improved. He never got his temperature. The highest in office was 99.5 degrees Fahrenheit. He had some muscle aches. The physician just sent patient to cardiology because he was having intermittent tachycardia and intermittent palpitations. Two visits to physician office. He was seen on 18Dec2020 and again on 21Dec2020. Relevant tests: they did testing for tachycardia but not related specifically. They did thyroid and EKG in office and he did not know if test were back. EKG was ok. The Thyroid, Complete blood count (CBC) and lipid (all were on an unknown date in Dec2020) were not back and were just done to make sure there were no cardiac issues. The outcome of the events was recovering. The lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events tachycardia and palpitations cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/17/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Electrocardiogram normal', 'Full blood count', 'Lipids', 'Myalgia', 'Palpitations', 'Pyrexia', 'Tachycardia', 'Thyroid function test']",UNK,PFIZER\BIONTECH,OT 918761,VA,62.0,F,"Cellulitis: below left elbow; Soft tissue swelling; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient (62 years old at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), intramuscular in left upper arm on 21Dec2020 13:00 at a single dose for COVID-19 immunization administered in the hospital. Medical history included ongoing hypertension and cervical cancer from 2015 and ongoing. The patient has been taking unspecified concomitant medication/s. The patient previously took amoxicillin and had allergies and nausea. On 24Dec2020 16:00, patient had cellulitis below left elbow and soft tissue swelling. On 25Dec2020, patient went to ER and X-ray was taken and patient was prescribed Keflex 500mg 3x day. Prior to vaccination, the patient was not diagnosed with COVID-19: Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of cellulitis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/24/2020,3.0,PVT,,Cervical cancer; Hypertension,,,,"['Cellulitis', 'Soft tissue swelling', 'X-ray']",1,PFIZER\BIONTECH,OT 918762,OR,61.0,F,"congestion in the throat and upper lungs; congestion in the throat and upper lungs; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular on the left arm on 21Dec2020 09:30 at a single dose for COVID-19 immunization. The patient's medical history included herpes 2. The patient was not pregnant. The patient had no known allergies to medications, food, or other products. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 26Dec2020 09:00, the patient experienced congestion in the throat and upper lungs. Oxygen level was 98 and temperature was 97.7. She had a good diet, no dairy, and no Christmas junk food, so for the patient, it was inexplicable. She was also consistent at mask wearing and all the precautions. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were reported as non-serious.; Sender's Comments: Considering the temporal gap between the vaccination and the event onset, the Company considers the event pulmonary congestion is unlikely related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/26/2020,5.0,PVT,,,Medical History/Concurrent Conditions: Herpes infection,,,"['Pulmonary congestion', 'Respiratory tract congestion']",1,PFIZER\BIONTECH,OT 918763,FL,,F,"She was hospitalized for a month Occurred after a flu two months prior and a stomach flu 2-3 weeks prior; She was hospitalized for a month Occurred after a flu two months prior and a stomach flu 2-3 weeks prior; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. Medical history included guillain-barre syndrome from 2011 at the age of 65 and Levaquin allergy. The patient's concomitant medications were not reported. On an unspecified date, the patient was hospitalized for a month that occurred after a flu two months prior and a stomach flu 2-3 weeks prior. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Guillain Barre syndrome (Caller had Guillain Barre in 2011 at age 65),,,['Unevaluable event'],UNK,PFIZER\BIONTECH, 918764,NY,40.0,F,"I got my left arm pit, lump on it, I have bigger than 1 cm 2 lumps, hidradenitis/Pain under my arm; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Mastitis; I got Myalgia all over the body, especially on my shoulders and back; I had chills but my temperature was normal; This is a spontaneous report from a contactable physician (patient herself). This physician reported information for herself (mother) and baby. This is the mother case. A 40-year-old female patient received her first dose of bnt162b2 (BNT162B2, also reported as Pfizer Covid-19 Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 20Dec2020 18:30 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient informed that she got in her left shoulder and left arm pit, lump on it. It was bigger than 1 cm 2 lumps, hidradenitis under her pits arm same size on 21Dec2020. She also reported that she was nursing mom to her self-kid which is 16 months old. She had Mastitis right now (20Dec2020) and informed that she hadn't it her life before. She got her vaccine on Sunday (20Dec2020) in night. She started to have pain under her arm on monday afternoon (21Dec2020) and then since yesterday (20Dec2020) she had mastitis. The mastitis in the right side, lump and the in the left side, which was the site of the vaccine. She never got a fever but got myalgia all over the body, especially on her shoulders and back and also she had chills but her temperature was normal. The outcome of events was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event mastitis with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520371 Fetal case",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/01/2020,,PVT,,,,,,"['Axillary mass', 'Axillary pain', 'Chills', 'Hidradenitis', 'Injection site mass', 'Mastitis', 'Maternal exposure during breast feeding', 'Myalgia']",1,PFIZER\BIONTECH, 918765,CA,48.0,F,"26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreased perfusion added bilateral knee joint pain; 25Dec2020 added facial edema; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; throat scratchy and tight; throat scratchy and tight; 23Dec2020 slight swelling on feet and ankles; 23Dec2020 slight swelling on feet and ankles; Tingling and best flutter 5 minutes after administration; Tingling and best flutter 5 minutes after administration; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number: EJ1685, expiration date: Mar2021), intramuscularly on 22Dec2020 at 09:45 at single dose for COVID-19 immunization in hospital. The patient medical history included known allergies: Sulfa, Penicillin; fibromyalgia; hypertension; high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications included other medications was received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced on 22Dec2020 09:45 tingling and best flutter 5 minutes after administration; 23Dec2020 slight swelling on feet and ankles; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen, throat scratchy and tight; 25Dec2020 added facial edema; 26Dec2020 continued decreased perfusion added bilateral knee joint pain. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included diphenhydramine hydrochloride (BENADRYL) 50 mg every 6 hours. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: Flutter occurred 5 minutes after vaccination; a possible causal association between administration of the suspect vaccine bnt162b2 and the serious event onset cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Fibromyalgia; High cholesterol; Hypertension; Penicillin allergy; Sulfonamide allergy,,,"['Arthralgia', 'Cardiac flutter', 'Face oedema', 'Joint swelling', 'Oedema', 'Oedema peripheral', 'Paraesthesia', 'Peripheral swelling', 'Poor peripheral circulation', 'Throat irritation', 'Throat tightness']",UNK,PFIZER\BIONTECH,OT 918766,MT,48.0,F,"dizzy/feel faint; perspiring; like blood not getting to my head; had to get on hands and knees, crawl; felt like my heart may be racing 10 min after vaccine/heart felt off beat and like blood not getting to my head/heart rate was 142; felt like my heart may be racing 10 min after vaccine/heart felt off beat and like blood not getting to my head/heart rate was 142; arm sore day #1 and #2- not unexpected; This is a spontaneous report from a contactable Physician(patient). A 48-year-old female patient received first dose (BNT162B2, lot number EK5730) , intramuscular at Arm Right on 18Dec2020 14:15 at the 48-year-old at single dose for COVID-19 immunization. The medical history included elevated blood pressure , allergic to sulfa, hypertension and Covid. The concomitant products included alprazolam, diphenhydramine hydrochloride (BENADRYL), spironolactone, metoprolol for hypertension, colecalciferol (VITAMIN D 3). The patient previously took nubaine and experienced drug allergy. The patient also happened to be a physician in private practice and received the vaccine at her local hospital. The patient had hypertension which was under excellent control on metoprolol 25 mg. She took it as prescribed every day surrounding the vaccine. On day #1 at the vaccine she felt like her heart may be racing 10 min after vaccine was about 80 on 18Dec2020 14:25. nothing serious. The patient experienced arm sore day #1 and #2 and not unexpected. On about 7 pm the day after the vaccine 19Dec2020 she was tachy at rate of about 105. She took her metoprolol heart rate never came down. At about 9:30 pm on 19Dec2020 when her rate should have been about70- she got up from couch after falling asleep. Upon standing felt like she was very dizzy. Walked upstairs, started to feel faint, perspiring, heart felt off beat and like blood not getting to my head. She had to get on hands and knees, crawl and heart rate was 142 and sustained for almost a minute. It took over an hour for it to come back to 86 and stayed there all night. There was not treatment to all of the adverse events. The outcome of the events was Recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the palpitations, tachycardia and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,; BENADRYL; ; ; VITAMIN D 3,,Medical History/Concurrent Conditions: Blood pressure increased; COVID-19; Hypertension; Sulfonamide allergy,,,"['Dizziness', 'Dizziness postural', 'Heart rate irregular', 'Hyperhidrosis', 'Pain in extremity', 'Palpitations', 'Tachycardia']",1,PFIZER\BIONTECH,OT 918767,NY,42.0,F,"Severe rash; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730 (pending clarification)), intramuscularly at the left arm on 21Dec2020 at 16:00 (04:00 PM) at single dose for COVID-19 immunization. The patient was vaccinated at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient's medical history included Diabetic, type 1, allergies to penicillin, and the patient diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient previously took codeine and experienced allergies. The patient received other unspecified medications within 2 weeks of vaccination. The patient experienced severe rash on 23Dec2020 at 21:30 (09:30 PM). The adverse event resulted in emergency room/department or urgent care: the patient was treated at local ER with prednisone and benadryl. The event was reported as non-serious. The patient recovered from the severe rash on an unspecified date in Dec2020.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of severe rash. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/23/2020,2.0,PVT,,,"Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?:Yes); Penicillin allergy (Allergies to medications, food, or other products: Yes. Penicillin and codeine); Type 1 diabetes mellitus",,,['Rash'],1,PFIZER\BIONTECH,OT 918768,NY,51.0,F,"Diarrhea persisted 24 hours with mucous and bloody mucous after all fecal material was exhausted.; Did have one episode of chills; This is a spontaneous report from a contactable physician. A 51-year-old female patient received the first dose of bnt162b2 (BNT162B2) lot no: EK9231, intramuscular on 23Dec2020 09:45 at a single dose for COVID-19 immunization in workplace clinic. Medical history included hypothyroid, allergies from bee sting, and covid-19 from Apr2020, all unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient did not receive other vaccine in four weeks. On 25Dec2020, in the late evening at 11:45 PM-almost midnight, the patient experienced diarrhea, severe, without nausea or vomiting. Did have one episode of chills that resolved. Diarrhea persisted 24 hours with mucous and bloody mucous after all fecal material was exhausted. The patient had COVID-19 in Apr2020 and had positive antibodies in Jun2020 with high titers. She confirmed with their ID chief that she should proceed to receive the vaccine. Diarrhea resolved in 24 hours. Some lingering increased GI activity. No fever (temp 99.0F) (Dec2020). The patient recovered from events without treatment in Dec2020. The events were reported as non-serious. The patient was not tested for COVID-19 post vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of diarrhea, severe cannot be excluded, considering the plausible temporal relationship and the known adverse profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/25/2020,2.0,WRK,SYNTHROID,,Medical History/Concurrent Conditions: Bee sting hypersensitivity; COVID-19; Hypothyroidism,,,"['Chills', 'Diarrhoea', 'Haematochezia']",1,PFIZER\BIONTECH,OT 918770,GA,54.0,F,"Difficulty breathing; This is a spontaneous report from a contactable pharmacist. A 54-year-old female patient received her first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at 04:15 PM at single dose in left arm for COVID-19 immunisation at the age of 54-year-old. Lot number was ELO140. Medical history was unknown, concomitant medications were unspecified. Patient was not pregnant at the time of vaccination. On 22Dec2020 at 04:30 PM, the patient experienced difficulty in breathing, and she was hospitalized for one day. The patient was treated with EPI for the event. The patient was recovering from the event.; Sender's Comments: Based on the compatible temporal association, the Company considers the event difficulty in breathing is possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/22/2020,12/22/2020,0.0,WRK,,,,,,['Dyspnoea'],1,PFIZER\BIONTECH,OT 918772,IL,47.0,F,"short of breath; Intense headache; tiredness; body aches; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ELO124), via an unspecified route of administration on 23Dec2020 at 14:30 on Left arm at single dose for COVID-19 immunization in hospital. The patient medical history included Rheumatoid arthritis, lupus. No known allergy, no allergies to medications, food, or other products. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included baricitinib (OLUMIANT), hydroxychloroquine, prednisone. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Intense headache, tiredness, body aches, short of breath on 24Dec2020; events were resulted in: Doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had been tested for COVID-19 on 27Dec2020: Nasal Swab, result was unknown. No treatment was received for the events. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,OLUMIANT; ;,,Medical History/Concurrent Conditions: Lupus erythematosus systemic; Rheumatoid arthritis,,,"['Dyspnoea', 'Fatigue', 'Headache', 'Pain', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 918773,UT,47.0,F,"have COVID; have COVID; bone-crushing-pain; fever; This is a spontaneous report from a contactable consumer reporting for a patient (nurse). A 47-year-old female patient received first single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 20Dec2020 for immunization. The patient's medical history concomitant medications were not reported (unknown). Patient was an ER Nurse and took first dose of vaccine and then described mild/moderate symptoms on day one only. On 23Dec2020, patient posted they have COVID (positive COVID test). Contracted from spouse who got it from work. She further described it as ""hit by a truck."" On Day 4 she describes her COVID symptoms: bone-crushing-pain when fever rises. Symptoms were COVID symptoms, not directly related to vaccine. The events/symptoms started on 20Dec2020. Patient had no Covid prior vaccination. The patient was COVID tested post vaccination. The patient considered the events as non-serious. The outcome of events was not recovered. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/20/2020,0.0,PVT,,,,,,"['COVID-19', 'Exposure to SARS-CoV-2', 'Malaise', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 918774,OR,93.0,M,"abdominal pain; nausea; high blood pressure; This is a spontaneous report from a contactable consumer. A 93-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included diabetic and irritable bowel. The patient's concomitant medications were not reported. The patient received the COVID vaccine and had abdominal pain, nausea and high blood pressure within 12 to 18 hours of vaccine received. The events lead to nursing home to emergency room and admitted to hospital. The patient was hospitalized due to events since 23Dec2020. Outcome of the events was recovering.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/22/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: Diabetic; Irritable bowel,,,"['Abdominal pain', 'Blood pressure increased', 'Hypertension', 'Nausea']",UNK,PFIZER\BIONTECH, 918775,WI,49.0,F,"Golf ball size lump in armpit of injection arm; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on left arm on 19Dec2020 18:15 at SINGLE DOSE for COVID-19 immunization. There was no medical history reported. Concomitant medication included estradiol (ESTROGEN), and meloxicam. On 26Dec2020 08:00, the patient experienced golf ball size lump in armpit of injection arm. The patient did not receive treatment for the adverse event. The outcome of the event was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/26/2020,7.0,PVT,ESTROGEN;,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Axillary mass'],UNK,PFIZER\BIONTECH, 918776,OK,40.0,F,"I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shaky and breathless; It's just little bit shaky and breathless; allergic reaction; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (BNT162B2, lot number: EK5730), via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 vaccination. There were no relevant medical history and concomitant medications. The patient reported that on an unspecified date, she had an allergic reaction. She had vasovagal reaction and seizures. Vasovagal was an allergic reaction that happened, and added that basically it's an allergic reaction. The patient experienced fever, headache, and weakness like right now. It was just little bit shaky, ever since yesterday and she had been way off like she take it as instruction yesterday, weakness, headache and breathless did not stopped from yesterday. The patient had been taking Tylenol for fever and headache. The patient reported that the events persisted. On 24Dec2020, lab work was done at the hospital, and she was told that the lab work was okay and they did CT scan of head because she developed seizure. She had seizure like 3 times so they scanned her brain. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Computerised tomogram head', 'Dyspnoea', 'Headache', 'Hypersensitivity', 'Laboratory test normal', 'Presyncope', 'Pyrexia', 'Seizure', 'Tremor']",UNK,PFIZER\BIONTECH, 918778,CO,29.0,F,"developed a migraine; nausea; sensitivity to light and sound; sensitivity to light and sound; she developed significant loss of mental clarity (brain fog); On 18Dec in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the the touch. This lasted about a total of 36 hours and progressively improve; brain fog; retroorbital headache/intermittent mild tension type frontal headache; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received first dose BNT162B2 (lot number EH9899), via an unspecified route of administration on 17Dec2020 12:00 at 29 years old at single dose at Left arm for COVID-19 immunization. Medical history included Mirena IUD, personal and family history of retinal migraines (without headache). The concomitant medications were magnesium citrate, melatonin, ademetionine (SAME) and fish oil. On 18Dec2020 in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the touch. This lasted about a total of 36 hours and progressively improved. There was no swelling, redness, or other local symptoms. In the afternoon on 18Dec2020, she developed significant loss of mental clarity (brain fog) while at work. In the evening on 18Dec2020, developed mild retroorbital headache (this was actually the first headache of my life). All day 19Dec2020 and about half the day of 20Dec2020 developed a migraine (also the first of my life), experienced as retroorbital pounding headache, sensitivity to light and sound in 19Dec2020, nausea without vomiting in 19Dec2020, and loss of mental clarity. She had intermittent mild tension type frontal headache on 20Dec2020 PM with all other symptoms resolved, all symptoms resolved by 21Dec2020 AM. The patient used naproxen 440 mg and Tylenol 1000 mg on 19Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not Allergic to medications, food, or other products. The outcome of the events was recovered on 21Dec2020. The information on the batch number has been requested.; Sender's Comments: Based on information available, the reported loss of mental clarity together with other events was likely related to the first dose BNT162B2 due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,; ; SAME [ADEMETIONINE];,,Medical History/Concurrent Conditions: Intra-uterine contraceptive device; Retinal migraine (personal and family history of retinal migraines (without headache)),,,"['Condition aggravated', 'Feeling abnormal', 'Headache', 'Hyperacusis', 'Injection site pain', 'Migraine', 'Nausea', 'Photophobia']",1,PFIZER\BIONTECH, 918779,FL,56.0,F,"husband and daughter tested positive/after taking the shot, she was feeling sick and had a fever/wondering if the vaccine can give the reaction, or maybe she has the virus; husband and daughter tested positive/after taking the shot, she was feeling sick and had a fever/wondering if the vaccine can give the reaction, or maybe she has the virus; having a lot IO symptoms; fever; has been feeling ""sick""; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the left arm on 22Dec2020 at single dose for COVID-19 immunisation. The patient's husband and daughter tested positive (COVID-19). There were no concomitant medications. The patient stated, ""had the first vaccine shot, later clarified as Pfizer COVID vaccine, on 22Dec2020, and didn't have any symptoms before that, her husband and daughter tested positive, but she was staying away from that, had no symptoms, but after taking the shot, on 24Dec2020, she was feeling sick and had a fever, and has had a fever ever since, and she is taking Tylenol and Motrin every six hours, and even then she still gets the fever, it hasn't stopped, she is having a lot IO symptoms, and is wondering if the vaccine can give the reaction, or maybe she has the virus. On 24Dec2020 is when the fever started and she was feeling sick. States she filled out a report online, on (Website)"". The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/24/2020,2.0,UNK,,COVID-19 virus test positive (husband and daughter),,,,"['Malaise', 'Pyrexia']",UNK,PFIZER\BIONTECH, 918780,MD,26.0,M,"his gums became discolored and turned purple/gums (both sides up and down) remain purple/discoloration to the gums in his mouth; his mouth started hurting; feeling hot; Body aches; Fever; Pain to the gums in his mouth; muscle aches; sore throat; neck pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration to right shoulder on 24Dec2020 11:30 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received vaccine on 24Dec2020. He experienced body aches, fever, and feeling hot with onset of about 3-4 hours after he was administered (24Dec2020). Next day (25Dec2020), his mouth started hurting, his gums became discolored and turned purple. Gums (both sides up and down) remained purple. He will be seeing a dentist. He also reported pain and discoloration to the gums in his mouth on 25Dec2020. He had been experiencing some of the regular side effects such as muscle aches, sore throat, neck pain on an unspecified date in Dec2020. Outcome of the event gum discoloration was not recovered, of the events feeling hot, generelized aching, and fever was recovered on 26Dec2020, of the event gum pain was recovering, and of the remaining events was unknown. He reported seriousness criteria as what he thinks to be medically significant at this point; that they could be medically significant. He is scheduled to receive the second dose of the product which at this point he does not plan to change. Dose change is unknown until he determines cause of these events and on what the doctor and dentist he is going to see recommend. He believes events could be caused by the vaccine. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/01/2020,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Feeling hot', 'Gingival discolouration', 'Gingival pain', 'Myalgia', 'Neck pain', 'Oral pain', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 918782,NY,,F,"extreme muscle ache that she couldn't move; I couldn't take the pain/severe body ache severe like I couldn't walk; I couldn't take the pain/severe body ache severe like I couldn't walk; extreme muscle ache that she couldn't move; High fever; Lot of chills; Itchiness; Hives; she was crying; This is a spontaneous report from a contactable Nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular on an unspecified date at single dose for covid-19 immunization. Patient history was no and investigation assessment was no. There were no concomitant medications. The patient had hives and itchiness and then that was the first day that was after 8 minutes and then the next day the patient had severe body ache severe like I couldn't walk, she cried. The patient took Tylenol and Ibuprofen as she couldn't take the pain (further clarification was unknown). The patient had high fever 102.4 and was having a lot of chills. Start date of event was 24th, the 23rd she had the hives and the 24th she had the extreme muscle ache that she couldn't move and she was crying and she had the chills and the fever on the 24th. So it on started 23rd with the hives so then it started with the body aches and the fever on the 24th. Outcome of the events was recovered. The causality between the events and drug was considered as related by the reporter via Global Introspection. Information on the batch/lot number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported body ache severe like I couldn't walk, extreme muscle ache that she couldn't move, and the administration of BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Crying', 'Gait disturbance', 'Myalgia', 'Pain', 'Pruritus', 'Pyrexia', 'Urticaria']",UNK,PFIZER\BIONTECH,OT 918783,TX,29.0,M,"left sided weakness; it has weakened his heart; stutter; severe stroke like symptoms; Ventricular tachycardia/help keep his heart rate at bay; Loss of balance; extreme numbness and tingling in left hand and foot; tingling in left hand and foot; oral motor impairment; mouth weakness and not coordinated/mouth is fatigued easily; Issues finding words and trouble speaking; Issues finding words and trouble speaking; Ejection fraction down to 25%; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 28Dec2020, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other healthcare professional (HCP). A 29-years-old male patient received bnt162b2 (lot number: EJ1685), intramuscular (deltoid left) on 21Dec2020 at 05:30 at 0.3 mL single (first dose) for Covid. Medical history was reported as ""none"". Concomitant medications were not reported. The patient previously received Flu vaccine in Oct2020 for immunization. The patient is an Occupational Therapist, and he called to report an adverse event that he experienced with the first dose of the COVID Vaccine. He received the vaccine last Monday, 21Dec2020 at 5:30AM before his shift at work, then 20 minutes later, he was having severe stroke like symptoms. He experienced severe left sided weakness, loss of balance, extreme numbness and tingling in his left hand and foot, he had issues finding his words and he couldn't speak, and he had an oral motor impairment where his mouth was weak and not coordinated. The staff at the hospital did a neurological exam on him, and he failed, so he had to go to the emergency room (ER). The patient added that he was already in the hospital when this happened, and the ER doctors suspected that he had a CVA, and they gave him TPA to prevent any permanent brain damage and it worked. The patient then added that due to the shock of this whole event, from everything that happened, it has weakened his heart. Reportedly, he is a healthy 29 year old man, with no preexisting conditions, and he works out, and he has no heart conditions, but he had to get a cardiology follow up a few days after he got the vaccine, because he started going in to Ventricular Tachycardia, which he had never had in his life. So, the doctors at the hospital went ahead and did an Echocardiogram and an EKG, and he was told that his Ejection Fraction is down to 25%. He stated his heart is so weak, that he cannot work right now, but the structure of his heart is fine and has not had any damage. The hospital staff thought that maybe the patient had a chronic heart issue that he just did not know about, and that the stress of this event maybe made it kick into overdrive, but he states that the cardiologist said that was not the case, because the structure of his heart is fine, and the only thing they can see is that the heart is pumping weak. One physician even suggested that due to the shock of the event, he might have Takotsubo Cardiomyopathy, which is a broken heart, but because the structure of his heart is okay, it should be reversible. He stated that he is hoping he will heal up good, because he is young and has no pre-existing conditions. He added that his heart is in such a state right now; he has to wear an external defibrillator. The patient stated that all these happened about 20 minutes after he received the vaccine, and he was admitted to the hospital from 21Dec2020 to 25Dec2020. His neurological symptoms have resolved except that he has a stutter that he did not have before and his mouth is fatigued easily, so he has to slow down when he is eating, but now he can eat regular for the most part. The patient confirmed that he was not specifically prescribed the product; it was administered to him at his place of work, but it was optional. He stated he considered how he is working with COVID patients every day, and given the circumstance, he thought that it would be a best practice for him to get the vaccine. He had not gone to his primary care doctor in a while because he had been fine and healthy, but he called them and found out that his primary care had retired, so he has to find a new one now. Regarding the issues finding words and trouble speaking, he stated that he has improved, but it is still ongoing, he is just stuck in a plateau zone. With the Ventricular Tachycardia, he stated that this is an ongoing issue, as he has to wear the life vest even though he has no need to activate it yet. He did have one minor bought of the VTach, but because he is a therapist, he knows how to take care of it with relaxation techniques, he knows how to manage it. He had one bought of VTach the evening prior, but he was able to get it under control. The doctors have him on medication to help keep his heart rate at bay. He has never had to use medication before and is on the following medications to help keep his heart rate at bay: Metoprolol 25mg one tablet once daily by mouth and Lisinopril 5mg one tablet once daily by mouth. The VTach has improved, it was good enough he was able to discharge home, but it is still a concern. His cardiologist said that, basically his hope, is that once his body recover from the whole shock of everything, then his ejection fraction will heal, and his heart will heal. He again stated that the doctor told him that the structure of his heart is perfectly fine; he has thick walls in his heart, no leaking valves, and the heart was not conducting any abnormal signals. The doctor just said that right now, his heart is super weak and that it is an acute problem. With the Takotsubo Cardiomyopathy, he states that two doctors mentioned this diagnosis, but he confirmed that he was not actually diagnosed with this issue, he was just diagnosed with Ventricular Tachycardia. The outcome of the ejection fraction down to 25% was unknown to the patient at this time as he has not had another EKG or echocardiogram, but the cardiologist told him that the cardiologist expects that this will not be resolved quickly anyway. The patient confirmed that he did not receive any other vaccines on the same day he received the COVID vaccine. The only other vaccine he had this year was the flu vaccine which he got back in Oct2020. He has gone on to his online portal and there are the bloodwork results and all the imaging results on there from his CTs and MRIs, but he did not see the EKG or Echocardiogram results yet. He does not have this pulled up at this time, but he does have access to this stuff and can provide it later, if requested. He is curious about the next steps from here to how his case is processed. He is also curious if this information would help Pfizer make modifications to the vaccine if it is found that a lot of people are having the same reaction as he did. He is also wondering, given his situation, that probably he is not going to get the second dose, for his safety, but he is wondering what percentage of effectiveness the first dose does having just covered. The events left sided weakness, loss of balance, extreme numbness and tingling in left hand and foot resolved on 25Dec2020; severe stroke like symptoms and oral motor impairment; mouth weakness and not coordinated/mouth is fatigued easily resolved in 2020. The events ventricular tachycardia/help keep his heart rate at bay and issues finding words and trouble speaking were resolving, stutter had not resolved while the outcome of the events it has weakened his heart, and ejection fraction down to 25% was unknown.; Sender's Comments: The reported information is unclear and does not allowa meaningful assessment of the case. It will be reassessed upon receipt of follow up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,12/21/2020,12/21/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Aphasia', 'Balance disorder', 'Cardiac assistance device user', 'Cardiac disorder', 'Cerebrovascular accident', 'Computerised tomogram', 'Dyskinesia', 'Dysphemia', 'Echocardiogram', 'Ejection fraction decreased', 'Hemiparesis', 'Hypoaesthesia', 'Impaired work ability', 'Magnetic resonance imaging', 'Muscle fatigue', 'Neurological examination abnormal', 'Occupational exposure to SARS-CoV-2', 'Paraesthesia', 'Speech disorder', 'Ventricular tachycardia']",1,PFIZER\BIONTECH,OT 918784,CT,42.0,F,"Left sided hearing loss; This is a spontaneous report from a contactable physician who was also the patient. A 42-year-old non-pregnant female patient received bnt162b2, lot number and expiration date were unknown, via an unspecified route of administration on 16Dec2020 , 8:30 at a single dose for covid-19 immunization. The patient's medical history included antiphospholipid antibody from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 22Dec2020, the patient experienced left sided hearing loss. It was unknown if patient received treatment for the event. The outcome of the event was not recovered. The patient was not diagnosed with COVID prior to vaccination and has not been tested for COVID-19 since vaccination. Patient has no allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information on the lot/batch number has been requested.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset. More information such as complete medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/22/2020,6.0,UNK,,,Medical History/Concurrent Conditions: Antiphospholipid syndrome,,,['Deafness unilateral'],1,PFIZER\BIONTECH, 918786,RI,23.0,F,"tightness in throat and lump in throat/had a tightness and lump in her throat; tightness in throat and lump in throat/had a tightness and lump in her throat; allergic reaction like rash, tightness in throat, and lump in throat; allergic reaction like rash/red rash on her chest and rash was on her arms too; cheeks were flushed; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar events for 3 patients. This is the first of 3 reports. A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK9231, intramuscular in the right deltoid, first dose on 27Dec2020 14:15 at a single dose for covid-19 prevention. Medical history included ongoing asthma and reactive airway which she was diagnosed when she was like 5 years old (2002). Concomitant medication included albuterol [salbutamol] for asthma which started when she was 8 years old or so. The patient wanted to know if she can receive the second dose of covid vaccine after experiencing symptoms of allergic reaction like rash, tightness in throat, and lump in throat. She wanted to know the ingredients and specific proteins in the covid vaccine. The patient received the COVID Vaccine and she developed a reaction. On 27Dec2020, she had a red rash on her chest, and her cheeks were flushed, and the rash was on her arms too, and she had a tightness and lump in her throat, it was not painful to swallow but she could feel the pressure with swallowing. She stated that she did not experience shortness of breath, but regardless, she was seen in the ER and she was given IV SOLUMEDROL, and BENADRYL, and she was watched for 5 or 6 hours and then she was sent home with an Epi Pen, around the clock Benadryl, and prednisone. She asked the ER doctors if they thought it was okay for her to receive the second dose of the product, and they told her to contact employee health for that question. She mentioned that she contacted that employee health and was told to contact her primary care provide which she did. Her primary care doctor instructed the caller to call Pfizer and gather some more information regarding ingredients, as the she may have had the reaction to a particular protein filler. She was also wondering if this is a known reaction to the product. She received the vaccine on 27Dec2020 at 2:15 PM. She reported that the red rash on her chest and arms, and her cheeks being flushed, resolved yesterday after receiving IV BENADRYL. Had a tightness and lump in her throat which was still ongoing, and it was kind of off and on and when the she takes Benadryl it goes away. She reported that this one is medically significant because even though she did not have shortness of breath, it could have affected her airway. She confirmed that she received no other vaccines on the same day as the COVID vaccine. The outcome of the events 'had a tightness and lump in her throat', allergic reaction was not recovered (a s reported); while recovered on 27Dec2020 for allergic reaction like rash/red rash on her chest and rash was on her arms too and cheeks were flushed.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events throat tightness, sensation of foreign body, allergy to vaccine, rash erythematous and flushing cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020517134 different patient, same drug and same event;US-PFIZER INC-2020517133 different patient, same drug and same event.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,UNK,ALBUTEROL [SALBUTAMOL],Asthma; Reactive airways disease,,,,"['Flushing', 'Hypersensitivity', 'Rash', 'Rash erythematous', 'Sensation of foreign body', 'Throat tightness']",1,PFIZER\BIONTECH,OT 918787,AZ,25.0,F,"Fever up to 120F; Bodyaches; Headache; dulled taste and smell; dulled taste and smell; Pain at the injection site; This is a spontaneous report from a contactable other HCP. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (reported as COVID 19 vaccine), intramuscular on 27Dec2020 12:00PM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The patient medical history was not reported. Concomitant medication included influenza vaccine (FLU) on 16Dec2020 at right arm. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other medications within 2 weeks of vaccination. The patient experienced fever up to 120F, bodyaches, headache, dulled taste and smell, pain at the injection site on 27Dec2020. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered. The events were reported as non-serious. Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between BNT162B2 and the event hyperpyrexia cannot be excluded based on compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,UNK,,,,,,"['Headache', 'Hyperpyrexia', 'Injection site pain', 'Pain', 'Parosmia', 'Pyrexia', 'Taste disorder']",1,PFIZER\BIONTECH,OT 918788,CA,45.0,F,"High blood pressure 187/95; Heart rate at one time 210 bpm; chest pain; Shortness of breath; This is a spontaneous report from a contactable pharmacist (patient) reported for herself that a 45-years-old female patient received first dose of BNT162B2 (lot number: EH9899), via intramuscular in left arm on 22Dec2020 07:00 AM at single dose for COVID-19 immunization. The patient was not pregnant. No known allergies. No allergies to medications, food, or other products. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested for COVID-19 since the vaccination. There were no medical history or concomitant medications. The patient experienced high blood pressure 187/95, heart rate at one time 210 bpm, shortness of breath and chest pain on 23Dec2020 10:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was received for heart rate at one time 210 bpm which included lab works and medication given propranolol to decrease heart rate. The outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events hypertension, heart rate increased, chest pain and dyspnoea cannot be excluded. The information available in this report is limited and this case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chest pain', 'Dyspnoea', 'Heart rate increased', 'Hypertension']",1,PFIZER\BIONTECH,OT 918789,MA,30.0,F,"She had an immediate reaction of accelerated heart rate and elevated blood pressure; She has very slightly elevated heart enzymes.; She had an immediate reaction of accelerated heart rate and elevated blood pressure; She's very anxious and very anxious tonight being alone at the hospital.; This is a spontaneous report from a contactable consumer (patient's father). A 30-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had an immediate reaction of accelerated heart rate and elevated blood pressure. She was monitored for an hour and it subsided. On unspecified date in Dec2020 at 1:00am in the morning she had racing heart rate and went to ER. She was still in hospital. Things were not entirely stabilized. She had very slightly elevated heart enzymes in Dec2020 with outcome of unknown. They keep her overnight for an echocardiogram in morning. The patient was very anxious being alone at the hospital. Caller questioned if this has been reported with the vaccine. Lot/Batch and Expiry date has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/18/2020,12/01/2020,,UNK,,,,,,"['Anxiety', 'Blood pressure increased', 'Echocardiogram', 'Heart rate increased', 'Immediate post-injection reaction', 'Myocardial necrosis marker increased', 'Palpitations']",1,PFIZER\BIONTECH, 918790,CA,33.0,F,"mental cloudiness; bruising of injection site; arm pain; fatigue; This is a spontaneous report from non-contactable Pharmacist (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at right arm on 19Dec2020 08:15 at single dose for Covid-19 immunization. The Covid-19 vaccine was administered in a hospital facility. Medical history included seasonal allergies, heartburn, and allergies to ethanol. The patient has no Covid prior vaccination. Concomitant medication included cetirizine, esomeprazole, melatonin; all from unspecified date for unspecified indication. The patient did not receive other vaccines in four weeks prior to the Covid vaccine. On 19Dec2020 at 15:00, the patient experienced bruising of injection site (x 1 week), arm pain, fatigue, mental cloudiness (approximately x 1 day). The patient was not tested post vaccination. The patient did not received treatment due to the events. The outcome of the events mental cloudiness, bruising of injection site, arm pain and fatigue was recovered in Dec2020. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event mental impairment cannot be excluded. The information available in this report is limited and this case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,; ;,,Medical History/Concurrent Conditions: Allergy to fermented products; Heartburn; Seasonal allergy,,,"['Fatigue', 'Feeling abnormal', 'Injection site bruising', 'Pain in extremity']",1,PFIZER\BIONTECH,OT 918791,MA,58.0,F,"30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; This is a spontaneous report from a contactable pharmacist. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), intramuscular on 19Dec2020 07:00 at SINGLE DOSE at Left arm for covid-19 immunization. Medical history included breast cancer female and allergies to shell fish and Latex. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 30 minutes after receiving vaccine on 19Dec2020 07:30 am, patient reported 'heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness. Patient was taken to the ED where she received IV Benadryl and was observed for 4 hours. Patient was discharged home and symptoms subsided. The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of the events was recovered in Dec2020.; Sender's Comments: There is a plausible temporal relationship between immunization and onset of allergic reaction in a subject with a positive medical history for allergy to food (shellfish); causality cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Breast cancer female; Latex allergy; Shellfish allergy,,,"['Chest pain', 'Dizziness', 'Flushing', 'Nausea', 'Palpitations', 'Tachycardia', 'Throat tightness']",1,PFIZER\BIONTECH,OT 918792,,,M,"exacerbation of cryptogenic organizing pneumonia; fever; malaise; wheezing; This is a spontaneous report from a contactable physician reported for himself. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration from an unspecified date at single dose for Covid-19 immunization. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. The patient experienced having fever and malaise after vaccination and then a few days later he has been wheezing. The patient believed it was an exacerbation of cryptogenic organizing pneumonia. The outcome of the events exacerbation of cryptogenic organizing pneumonia, fever, malaise and wheezing was unknown. Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: The association between the event cryptogenic organizing pneumonia with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Rheumatoid arthritis,,,"['Malaise', 'Organising pneumonia', 'Pyrexia', 'Wheezing']",UNK,PFIZER\BIONTECH, 918793,NC,69.0,M,"Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; sore arm; nerve related hearing loss; This is a spontaneous report from a contactable physician reporting for himself. A 69-years-old male patient received bnt162b2 (BNT162B2; Lot : EKS730) vaccine , intramuscular in the left deltoid on 21Dec2020 15:30 at single dose for covid-19 immunisation . Medical history included atrial fibrillation from 2009. There were no concomitant medications. The patient stated he experienced sore arm on the same day 21Dec2020 and this was not a big deal. On 26Dec2020 the patient experienced sudden onset of acoustic neuritis without labyrinthitis, hyperacusis, fullness in ears, dizziness and tinnitus . The patient also experienced nerve related hearing loss from Dec2020. Sore arm was considered non serious events, while the remaining were considered Important Medical Events. The outcome of nerve related hearing loss was recovered, the outcome of sore arm was unknown, while the outcome of the remaining events was recovering.; Sender's Comments: Based on the temporal association, it cannot be fully excluded that the vaccination with BNT162B2 might play a contributory role in the events onset. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/01/2020,,PVT,,,Medical History/Concurrent Conditions: Atrial fibrillation (Verbatim: Atrial fibrillation),,,"['Acoustic neuritis', 'Deafness neurosensory', 'Dizziness', 'Ear discomfort', 'Hyperacusis', 'Pain in extremity', 'Tinnitus']",UNK,PFIZER\BIONTECH,OT 918794,TN,58.0,F,"I have lost hearing in my right ear; the right side of my face was numb; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number number EJ1685, expiration date Mar2021, on 25Dec2020 09:30 at single dose on left arm for Covid-19 vaccination. Medical history and concomitant medications were none. The patient had not received other vaccine in four weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient received her first Covid-19 vaccination on Christmas morning. She worked at a medical center. Within an hour of when she got home, she lost hearing in one ear and also had some numbness on the same side of her face, She was wondering if that was something she should be concerned and she still didn't have hearing in her right ear. Treatment received for the events included Tylenol. The outcome of the events was not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/25/2020,12/25/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Deafness unilateral', 'Hypoaesthesia']",1,PFIZER\BIONTECH, 918795,CA,43.0,F,"She suspected that she had an undiagnosed autoimmune disease.; Spinal pain that elicits nausea; spinal pain that elicits nausea; Headache that is worse at night/Headache worse at night time, sometimes gets better during the day/bad head ache; Body aches; Feeling crappy; Low grade fever; Pressure in the head; Terrible pain; Neck pain; This is a spontaneous report from a contactable other health professional (patient). A 43-yearsold female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received Covid19 vaccine on 19Dec2020 and reported that at 36 hours she had body aches, feeling crappy, and low grade fever in Dec2020, she had since developed at headache that is worse at night, and spinal pain that elicits nausea. She suspected that she had an undiagnosed autoimmune disease. She was inquiring about duration of the reported AE's from clinical trials, and tried to decide how long she will feel this way. And going on 10 days and she's just struggling, bad headache and neck pain headache worse at night time, sometimes gets better during the day. Terrible pain and nausea. Any info on length of side effects: 36 hours- body aches feeling crappy. Low grade fever. Nausea with the spinal pain, pressure in the head. Difference in people with autoimmune issues- infertility - suspected autoimmune. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, there is no biological plausibility to implicate the suspect vaccine to the occurrence of the serious event autoimmune disease. More information such as medical history and concomitant medications and confirmative diagnostic workups are needed for full medial assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/01/2020,,UNK,,,,,,"['Head discomfort', 'Headache', 'Malaise', 'Nausea', 'Neck pain', 'Pain', 'Pyrexia', 'Spinal pain']",UNK,PFIZER\BIONTECH, 918797,GA,,F,"Heart rate high; Blood pressure high; bruise at the site of the vaccination; This is a spontaneous report from a contactable other health professional reporting for herself. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 22Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 22Dec2020, 1-1.5 hours after vaccination, the patient experienced heart rate high with outcome of unknown , blood pressure high with outcome of unknown and bruise at the site of the vaccination with outcome of unknown. The patient underwent lab tests and procedures which included: blood pressure, high (22Dec2020); heart rate, high (22Dec2020). She returned to the emergency room (ER) of the hospital where she received the vaccine due to all the events. Therapeutic measures were taken as a result of heart rate high and blood pressure high and included treatment with a beta blocker. The patient was also prescribed with a blood pressure medicine from the ER physician. The events heart rate high and blood pressure high were considered medically significant. The information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the Company considers the events heart rate high and blood pressure high are possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,PVT,,,,,,"['Heart rate increased', 'Hypertension', 'Injection site bruising']",1,PFIZER\BIONTECH, 918798,,49.0,F,"tingling of the lips/Lips tingled; Throat got tight; This is a spontaneous report from a contactable other hcp(patient). The 49-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, Expiry Date: 31Mar2021), via an unspecified route of administration at left arm on 21Dec2020 at single dose for COVID-19 immunization. There were no concomitant medications nor medical history. Patient got first dose of the COVID vaccine and experienced her lips tingled/ tingling of the lips and her throat got tight, both on 21Dec2020, led to medically significant, lasted about 20 minutes. They observed her and she did not need any further treatment. Outcome of events was recovered in 21Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of her lips tingled/ tingling of the lips and her throat got tight cannot be excluded, considering the plausible temporal relationship and the known adverse event (anaphylactic adverse reaction) profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Paraesthesia oral', 'Throat tightness']",1,PFIZER\BIONTECH, 918799,NY,67.0,F,"disoriented; hit her head and cut herself; hit her head and cut herself; Passed out at night; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose at left arm for COVID-19 immunization. Medical history included Atrial fibrillation/heart problems diagnosed prior to the vaccine, got the COVID virus on 18Nov2020, disoriented in Nov2020. Concomitant medications included her heart medication every day and vitamins, nothing out of the normal. Caller stated she had heart problems. The heart problems were diagnosed prior to the vaccine. Caller also stated that she got the COVID virus this year before the vaccine as well and she was off, of work for like a month. On 23Dec2020 she got the vaccine. Then on Thursday 24Dec2020 and Friday 25Dec2020 she had a reaction. She had passed out in the night, hit her head and cut herself, she was then disoriented for 1 full day. Caller stated that the last time she was disoriented like this was when she had the COVID Virus, because she had heart problems. Caller stated that she was fine now. Caller stated that she had been off, of work so much. The heart problem she had was Atrial Fibrillation. Caller clarified that she had the COVID virus this year in Nov2020, it was before thanksgiving, on 18Nov2020 she had the virus, then on 19Nov2020 she got tested and it was positive. She got the vaccine on the 23Dec2020 Wednesday then on 24Dec2020 at night she passed out and on 25Dec2020 she was disoriented all day. Investigation Assessment: No. On 24Dec2020 she was going to bathroom, and found herself on the floor, then the following day 25Dec2020 was when she was disoriented. She knew this because when she had the actual COVID virus previous in Nov2020 this happened previously. When queried outcome of being disoriented she stated that she still felt a little weird but if getting better very, very slow. The Second dose was schedule for 13Jan2021. Caller confirmed that she did have a Positive Test for Covid Previously. Her treatment at the time was in the Emergency Room, they gave her an Antibody infusion, she had to schedule it because it was actually a clinical trial. Caller was asked if she knew the name of covid test, she stated that she does not know, she only recalled that she opened her mouth and they test her that way. The outcome of the event ""disoriented"" was recovering, of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,UNK,,,Medical History/Concurrent Conditions: Atrial fibrillation (diagnosed prior to the vaccine); COVID-19; Disorientated,,,"['Disorientation', 'Feeling abnormal', 'Head injury', 'Loss of consciousness', 'Skin laceration']",1,PFIZER\BIONTECH, 918800,MD,,U,"Bells Palsy; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is 1st of three reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (also reported as Comirnaty), via an unspecified route of administration on an unspecified in Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced bells palsy on Dec2020. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020519118 same reporter/drug/event, different patient;US-PFIZER INC-2020519119 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,['Facial paralysis'],UNK,PFIZER\BIONTECH, 918801,MD,,U,"Bell's Palsy; This is a spontaneous report from a contactable consumer or other non HCP. This consumer reported same events for three patients (nurses). This is 2nd of 3 reports. A patient of an unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, also reported as COMIRNATY), via an unspecified route of administration on unknown date in Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were unknown. Healthcare worker reported that 3 nurses who work in her facility received Pfizer's COVID vaccine last week (Dec2020) came in with Bell's Palsy in Dec2020. Event took place after use of product. The outcome of event was unknown. No follow-up attempts are possible. Information about batch/Lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020519105 same reporter, same drug, same event, different patients;US-PFIZER INC-2020519119 same reporter, same drug, same event, different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,['Facial paralysis'],UNK,PFIZER\BIONTECH, 918802,MD,,U,"Bells Palsy; This is a spontaneous report from a contactable consumer or other non HCP. This consumer reported same events for three patients. This is a 3rd of 3 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, also reported as Comirnaty), via an unspecified route of administration on an unspecified in Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Healthcare worker reported that 3 nurses who work in her facility received Pfizer's COVID vaccine last week (Dec2020) came in with Bells Palsy. Event took place after use of product. The outcome of event was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020519118 same reporter, same drug, same event, different patients;US-PFIZER INC-2020519105 same reporter, same drug, same event, different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,['Facial paralysis'],UNK,PFIZER\BIONTECH, 918804,AR,70.0,M,This report is only in response to the request from the agency to submit all patients into VAERS that received the COVID19 vaccine and subsequently tested positive for COVID19. No other adverse reactions to the vaccine were reported. The patient reported a COVID19 positive test on 12/23/20.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/23/2020,6.0,PVT,,,,,,"['SARS-CoV-2 test positive', 'Unevaluable event']",1,PFIZER\BIONTECH,IM 918806,OH,39.0,F,"On Day 8 of vaccination (1/3/21) woke up with a sore arm, swelling and hard area. Slight pink area and warm to the touch. Mild itching occurred evening of 1/3/21. Cold compress applied, not helpful. On day 9 (1/4/21) all symptoms continue but increase of pain and heavy feeling in arm. Swelling is increased, pink area is increased. Remains warm to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/03/2021,7.0,WRK,"Sertraline, melatonin, Vit B-6, L-theanine drink daily nutrition shake for meal replacement",none,eczema,,none,"['Induration', 'Limb discomfort', 'Pain in extremity', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,IM 918807,AK,49.0,M,"Patient got his Covid vaccine this past Thursday, 2 days ago. He experienced typical side effects of a sore left shoulder and some fatigue but was feeling well until this afternoon around 1:55 PM when he noticed throbbing of his left hand. He looked down and noticed that there was a purple discoloration to his middle finger and distal palmar aspect of his hand. He felt like there was maybe some swelling as well and that he might have been having an allergic reaction so called the emergency department for further advice and came in for evaluation. By the time I arrived to the emergency department the patient's left hand was no longer swollen and there was only a small purple discoloration to the palmar proximal middle finger. I was concerned that the patient developed a small blood clot that was resolved upon evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/02/2021,2.0,PVT,None,None,"Obesity, pre-diabetes",,Latex allergy,"['Activated partial thromboplastin time shortened', 'Fatigue', 'Fibrin D dimer normal', 'Full blood count normal', 'Injection site pain', 'International normalised ratio normal', 'Metabolic function test normal', 'Pain', 'Peripheral swelling', 'Prothrombin time normal', 'Skin discolouration', 'Troponin normal']",1,MODERNA,IM 918808,NY,37.0,F,Fever of 101.5 and Heart palpatations,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,,,,,,"['Palpitations', 'Pyrexia']",1,PFIZER\BIONTECH,IM 918809,OK,26.0,F,"Severe headache, fever, and blood pressure drop leading to fainting starting the day after receiving the Pfizer-BioNTech COVID-19 Vaccine EUA.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/04/2021,1.0,PVT,,,None,,Penicillins,"['Blood pressure decreased', 'Headache', 'Pyrexia', 'Syncope']",1,PFIZER\BIONTECH,IM 918810,WI,39.0,F,"Erythema, swelling, warm to touch, around injection site. ""tingling down arm to metacarpals per patient""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"PRENATAL VITS W-CA,FE,FA,<1MG, (PRENATAL VITAMIN ORAL)",None,None,,None,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Paraesthesia']",1,PFIZER\BIONTECH, 918811,OH,25.0,F,"Sore arm, sore throat, post nasal drip, congestion, chest pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,UNK,Junel (oral contraceptives),,,,,"['Chest pain', 'Oropharyngeal pain', 'Pain in extremity', 'Respiratory tract congestion', 'Upper-airway cough syndrome']",1,PFIZER\BIONTECH,SYR 918812,OH,40.0,M,"Day 0-2 - left deltoid soreness, vague malaise Day 4 - unexplained anger Day 6-7 - bilateral quadriceps soreness, headache --- No treatment sought for any of the above. Patient took acetaminophen for headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,PVT,none,none,"OSA, on CPAP",,Keflex,"['Anger', 'Headache', 'Malaise', 'Myalgia', 'Pain in extremity']",1,MODERNA,IM 918813,MT,75.0,F,"After vaccination, recipient was seated in post-vaccine waiting area. She began to complain of feeling light-headed and having an ""itchy"" sensation in her tongue and mouth. She was escorted via wheelchair to the Emergency Department and administered p.o. Benadryl. After a period of time she was then released and returned to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Unknown,None,Unknown,,"Shellfish, cumin","['Dizziness', 'Tongue pruritus']",1,MODERNA,IM 918814,PA,35.0,M,"On 1/1/2020, I developed a rash on my palms that was pruritic. On 1/2/2020, the rash progressed to involve the soles of my feet, hard palate, and the rest of my body. The rash is papular and pruritic and has continued until 1/4/2020 without improvement. No associated fever or systemic symptoms. My daughter did have a febrile illness 2 days prior to the development of my rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/01/2021,9.0,PVT,None,None,None,,"Penicillin, tetracycline","['Oral mucosal eruption', 'Rash', 'Rash papular', 'Rash pruritic', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,IM 918815,MO,37.0,M,transient flushing nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Flushing', 'Nausea']",1,MODERNA,IM 918817,RI,44.0,F,"Fever to 101.4, myalgia, extreme fatigue, headache, nausea (Pfizer-BioNTech COVID-19 Vaccine EUA)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,PVT,None,None,None,,Penicillin,"['Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 918818,NC,60.0,F,"Debilitating frontal headache, accompanied by nausea and vomiting, and fatigue for 16 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,"Protonix 40mg daily, Multaq BID, Cymbalta 60mg daily Olive leaf, Flintstones complete vitamin, Calcium with D3 and magnesium, Vitamin C with rose hips, Tylenol BID",,Cardia dysrhythmia,,"Sulfa-rash, Nitrofurytoin- dysphagia, Levaquin- insomnia, Albuterol - extreme tachycardia Black walnut-anaphylaxis, raw apple-oral allergy, Bahia grass/seed/hay - depending on exposure; rash or wheezing to anaphylaxis, Mold/Mildew- 24 hour delayed reaction/rash, Dust- puritis/ nasal congestion, Timothy grass- wheezing, Sand fleas - puritis/hives/near anaphylaxis","['Asthenia', 'Fatigue', 'Headache', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 918819,CA,53.0,F,"Woke the next morning and experienced blackouts but it resolved after lying down and a few hours later. Felt very cold for 48 hours. Fatigue and injection site soreness. Slight nausea, sore throat and chest congestion. Heavy chest and my skin hurts. Stiff neck.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,PVT,Trazodone 100 mg bedtime Progesterone 100 mg daily Estradiol 1 mg daily,NONE,NONE,,NKDA,"['Chest discomfort', 'Fatigue', 'Feeling cold', 'Injection site pain', 'Loss of consciousness', 'Musculoskeletal stiffness', 'Nausea', 'Oropharyngeal pain', 'Pain of skin', 'Respiratory tract congestion', 'SARS-CoV-2 test']",1,MODERNA,IM 918820,OH,54.0,F,"Patient received the covid vaccine and 6 hours later developed headache and aches which progressed to fever,chills, severe headache, aches and nausea. Symptoms resolved in 30 hours. Patient took Tylenol, Motrin, and Zofran for symptom management.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"Atarax as needed, Miralax as needed",None,None,,IVP dye,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 918821,CA,42.0,M,Moderna COVID-19 Vaccine- Rash around administration site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,WRK,none,none,none,,none,['Injection site rash'],1,MODERNA,IM 918822,MO,54.0,F,Sever muscle aches and body pain along with a severe migraine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,WRK,Flexeril 10 mg- 2 at HS-maintenance migraines Omeprazole 20 mg -1 at HS (acid reflux) Cymbalta 60 mg 1 at HS (generalized anxiety disorder in remission since 2003) Levothyroxin 100 MCG 1 before breakfast,None,Chronic Migraines,,"Suifa, Zonegran, Lipitor, Zocor, Zetia, Red Yeast Rice","['Condition aggravated', 'Migraine', 'Myalgia', 'Pain']",UNK,MODERNA,IM 918824,,0.25,F,Sore jaw across the bottom around noon - seeing lights,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,SEN,Tylenol 500mg - 2x week Lisinprol,,,,,"['Pain in jaw', 'Photopsia']",1,PFIZER\BIONTECH,IM 918826,TX,48.0,M,"Delirium and cognitive dysfunction, memory loss. Trouble concentrating. High fever, body aches, headache. Delirium subsided after 2 days. High fever, body aches and headache went away after 3 days. Cognitive difficulty and memory loss persist.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/25/2020,2.0,PVT,"escitolopram, metoprolol, zyrtec, crestor",none,"controlled ptsd, htn, dyslipidemia",,none,"['Amnesia', 'Cognitive disorder', 'Delirium', 'Disturbance in attention', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 918827,FL,44.0,F,individual has a swollen left lymph node axillary and neck on same side as vaccine (administered tues 12/29/2020) swelling noted on Friday evening (1/1/2021). No other symptoms at all. Visibly swollen upon examination on 1/4/2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/01/2021,3.0,PVT,No,NO.,No.,,No,['Lymphadenopathy'],1,MODERNA,IM 918828,OH,39.0,F,"on 1/3/20 on day 8 of vaccine, woke up with arm soreness and swelling, lump and slight pink around injection site and warm to the touch. later that evening on 1/3/21 slight itchiness. Cold compress applied, no improvement. On 1/4/21, day 9, the symptoms all remain with worse swelling, more pink area and ongoing soreness and feeling of heaviness to the arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/04/2021,8.0,WRK,"sertraline, melatonin, b-6, l-theanine and daily nutrition shake",none,eczema,,none,"['Injection site erythema', 'Injection site mass', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Limb discomfort', 'Pain in extremity']",1,MODERNA,IM 918829,NJ,21.0,M,On and off rapid heart beat,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,UNK,none,none,none,,none,['Heart rate increased'],1,PFIZER\BIONTECH,SYR 918830,WA,56.0,F,"Rash was itchy, raised, 2 clusters about 10 each, small dots, red. On L rib cage. No face lesions, itchy throat, no difficulties breathing, no wheezing, no dizziness, no dysphagia. Her rash is getting better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PUB,,,,,,"['Rash', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",1,MODERNA,IM 918832,NH,55.0,F,"Pain at injection site, fatigue, chills, fever, headache, nausea. Symptoms started 6 - 12 hours after injection, and most resolved 36 hours after injection. The pain at injection site lasted for 3 days.. Symptoms were treated with Ibuprofen, Acetaminophen, and rest at home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Macrobid,UTI,,,PCN,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pyrexia']",1,MODERNA,IM 918834,IL,27.0,F,"After the shot I was very light headed , and was taken to the side. Ate some candy , and felt better after. About 6 days later is when I woke up with really puffy eyes. Then next day I noticed swelling on the bottom of my mouth , on both sides. Also , my whole right side of my face is swollen with a lot of pressure in it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/28/2020,6.0,WRK,"Benadryl every night due to allergies Allergy shot every other week for allergies (dust mites , rag weed) Fish oil Women's multi vitamin Women's vitamin hair, skin , and nails Protein supplement -Whey ISO protein powder",None,None,,"Allergic to: nickel , dust mites , rag weed","['Discomfort', 'Dizziness', 'Mouth swelling', 'Periorbital swelling', 'Swelling face', 'White blood cell count increased']",1,PFIZER\BIONTECH,SYR 918835,CO,27.0,F,"24 hours after injection I developed a welt at the injection site that was raised, hot to the touch, sore, and about one and a half inches in diameter. The welt slowly disappeared within three days. Six days after the injection I tested Covid positive (transmitted from family most likely). The welt returned and began to itch and spread. Eight days after injection and two days after testing positive the welt was 5 inches in diameter. Nine days after injection and three days after testing positive the welt started to disappear again.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,WRK,Yaz birth control Ritalin IR,None,None,,None,"['COVID-19', 'Injection site pain', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'SARS-CoV-2 test positive', 'Urticaria']",1,MODERNA,IM 918836,ME,61.0,F,Rash/Hives day after vaccine continual and increasing itching. Takjng Zurtec and Benedryl,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,WRK,Escitalopram Amlodipine Losartan Potassium Advil Tylenol,,,,Penicillin Sulfa Drugs,"['Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,SYR 918837,CA,42.0,F,"Got vaccine on 12-29 @ 9:40 , same day around 8pm had a rash with bumps from back of right arm down to wrist with little bumps, really red...had on left arm as well. next day on 12- 30 around 1:30pm co worker told me my neck was really red. I told her I was just hot from working, but by 3pm I had bumps, itchy, big raised red spots....right side was worse then left side but it did cross my whole neck. my arms cleared up but when I get hot it comes out enough to see where it was located. on sat Jan 2nd the bottom of my right ear swelled and had like a white like bump....but, as soon as I cooled off because I was hot it totally went away. today is Mon Jan 4th and my neck looks like the bad rash area has burned into my neck....I have been taking Benadryl cr�me on neck and Friday Dec 1st I started Benadryl pills but stop taking pills after sat Jan 2nd because I was just to tired.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,"I took 2 Tylenol an hour before the vaccine was given. that morning at 530 am I take vitamins: multi vitamin, vitamin c, turmeric, fish oil, B-12, calicum",none,Rheumatoid arthritis is the only condition that I know of,,not that I know of,"['Ear swelling', 'Rash', 'Rash erythematous', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 918838,CA,56.0,M,"lightheaded and nauseous lasting 2 days, fatigue, chills. Staying hydrated",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,WRK,"Lotril, multi vitamin, fish oil",,,,,"['Chills', 'Dizziness', 'Fatigue', 'Nausea']",UNK,MODERNA,IM 918839,WA,32.0,F,"Gallbladder removed, septic, 11mm axillary lymph node.",Not Reported,,Yes,Not Reported,,Not Reported,U,12/24/2020,01/01/2021,8.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Cholecystectomy', 'Lymphadenopathy', 'Sepsis']",1,MODERNA,IM 918840,TN,55.0,F,"I am a nurse and received the Moderna COVID19 vaccine as part of my facility's COVID clinic. CVS Pharmacy staff came to my facility to administer vaccines to staff and residents. Pharmacist notified of my reaction and recommended reporting on this website as listed on fact sheet provided. I had mild tingling to bilateral hands and arms within 2 minutes of vaccine administration and it lasted approximately 20 minutes, then subsided. VS monitored by nursing staff and WNL. No tachycardia or respiratory distress.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,WRK,"Vitamin D 2000 IU PO daily, Ferrous Sulfate 325 mg PO daily , B12 1000 mcg PO daily.",None,None,,Diflucan,['Paraesthesia'],1,MODERNA,IM 918841,PA,26.0,F,Migraine; Feeling foggy; Malaise; Swollen lymph nodes; Could not lift arm more than a few inches,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,PVT,,,,,,"['Feeling abnormal', 'Lymphadenopathy', 'Malaise', 'Migraine']",UNK,PFIZER\BIONTECH,IM 918842,WA,40.0,F,Hives/rash on both arms and chest,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/02/2021,2.0,PVT,Telmasartan hctz Birth control Fioricet Zolpidem Alprazolam,,Migraine High blood pressure Anxiety Insomnia,,Penicillin,"['Rash', 'Urticaria']",1,PFIZER\BIONTECH,SYR 918843,NC,52.0,F,"Does not know if this was vaccine related or not, but patient had onset of GI bleeding and went to the ER. Got diagnosis of diverticulitis.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,SEN,"Estradiol, progesterone",None,"IBS, asthma",,Sulfa antibiotics Emycin,"['Blood test', 'Computerised tomogram', 'Diverticulitis', 'Gastrointestinal haemorrhage']",1,MODERNA,IM 918844,NY,28.0,F,"Patient developed SOB, wheezing, tongue swelling, facial tingling.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,unknown,unknown,none,,None,"['Dyspnoea', 'Paraesthesia', 'Swollen tongue', 'Wheezing']",2,PFIZER\BIONTECH,IM 918845,CA,52.0,F,"injection site was red and had a rash achy chills extreme joint pain on left side, hip, knee and ankle cough",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,UNK,,,,,,"['Arthralgia', 'Chills', 'Cough', 'Injection site erythema', 'Injection site rash', 'Pain']",1,PFIZER\BIONTECH,SYR 918846,WV,41.0,F,"Received on 12/22/20 at about 130pm, symptoms noted around 12/23/20 at 7:00 am, stiffness in the right hand, with numbness and tingling of the right arm, weakness, decreased strength, 5-6 days later pain in the right axilla. The pain in the axilla resolved, continues with the other symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,OTH,None,None,none,,No known allergies,"['Asthenia', 'Axillary pain', 'Hypoaesthesia', 'Musculoskeletal stiffness', 'Paraesthesia']",1,MODERNA,IM 918847,IA,68.0,F,"12/29 Injection site soreness 12/30 Fatigue, SOB, cough, muscle aches, mental slowness; increased secretions with cough",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PUB,Albuteral inhaled solution 0.0833%; Amoxicillin/Clavulanate; Z-pack (Arithromycin); Aspirin; Atorvastatin; Azlastine nasal spray; Buproprion; Levothryroxine; Motrin; Mucinex; Cefdinir; Clotramazole; Difucan; Doxycycline; Fluconazole; Liothy,COPD,Sjordens Syndrome,,Vent Foam,"['Blood gases abnormal', 'Cough', 'Dyspnoea', 'Fatigue', 'Fibrin D dimer normal', 'Injection site pain', 'Laboratory test', 'Mental impairment', 'Myalgia', 'Respiratory viral panel', 'SARS-CoV-2 test negative']",1,MODERNA,IM 918848,MD,58.0,F,"Placement of vaccine was incorrect: closest to the shoulder joint vs the location closest to the deltoid tuberosity of the humerus. Pain 9/10 on scale 1-10, with 10 being worse pain approximately 5 hours after placement. Unable to lift arm without manipulation. Required Motrin 600-800 mg PO every 8 hours around the clock. Duration of pain = 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,,none,NIDDM,,Oxycodone Erythromycin Macrodantin,"['Mobility decreased', 'Pain', 'Product administered at inappropriate site']",1,MODERNA,IM 918850,TX,39.0,F,"I got the vaccine in my right arm. About 30 min after the vaccine, I started feeling numbness/tingling in my right jaw/mandible area that spread behind my ear. Over about an hour or 2 I could feel the numbness/tingling/strange sensation move across the top of my right lip and into my right nostril. I took benadryl and it seemed to stop the spreading but the strange sensation stayed on the right side of my face for about 4 days afterwards.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,WRK,"Adderall XR 15MG, Losartin/HCTZ 50/12.5MG",No,,,No,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Nasal discomfort', 'Paraesthesia', 'Paraesthesia oral', 'Sensory disturbance']",1,PFIZER\BIONTECH,IM 918851,AR,62.0,F,This report is being submitted per request of the Department of Health to submit all patients who tested positive for COVID19 after receipt of the COVID19 vaccine. No other adverse reactions were reported. This patient tested positive for COVID19 on 12/27.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/16/2020,12/27/2020,11.0,PVT,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 918852,TX,,F,"A few hours after vax I got the chills. Had PCP appt after and they stated they could not get a reading on pulse ox. temp was 97.0. I went home and tried to get warm but could not. Day after I rcvd the shot my arm was hurting, Puffy and bruised around injection site. warm to touch around site with a hard lump. The whole weekend I have been nauseated and throwing up and very tired.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,"tizanidine, hydocodne, ibuprophen",no,"scoliosis, fibromyalgia, arthritis, asthma",flu shot 2019 or 2020,flu shot - 2020 allergic reaction,"['Chills', 'Fatigue', 'Injection site bruising', 'Injection site induration', 'Injection site mass', 'Injection site warmth', 'Nausea', 'Pain in extremity', 'Skin swelling', 'Vomiting']",1,PFIZER\BIONTECH,IM 918853,TX,32.0,F,I had a sore arm the next day. I had head ache and joint pain but not sure if it's from the vaccine or my Chronic condition. I have called my doctor to follow up. Currently taking Prednisone.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/15/2020,12/15/2020,0.0,WRK,Hydroxychloroquine,,Lupus,,,"['Arthralgia', 'Headache', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 918855,TX,43.0,M,"Dizziness on the day of injection. Followed by extreme fatigue, fever (101.4), headaches starting 24 hours after injection and lasting 48 hours. Sense of smell began to return after 36hrs after injection (lost smell and taste in August 2020 due to COVID-19 and it has not returned).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,,None,,,NKDA,"['Dizziness', 'Fatigue', 'Headache', 'Parosmia', 'Pyrexia']",1,MODERNA,IM 918857,,53.0,F,"Severe headache. chills, body ache, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,SCH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pain']",1,MODERNA, 918858,CA,54.0,F,"I got Pfizer vaccine on 12/29. Had muscle soreness at site, Stomach cramp same day after 35 mins of shot. Mild lower back pain that evening (vaccine on left arm and pain on same side). On 12/30 soreness was only to palpation. Rhinorrhea all day long, took NyQuil, moderate back pain, took naproxen and did some back stretches. On 12/31 no sore arm but little tender. Increased back pain , used back brace , took naproxen not that much help though. used heat pack finally fall asleep around 3 am. on 01/01/2121 around 6 am woke up with excruciating left lower back pain, could not move, get off the bed. took a while to get off the bed. Have to drag my legs very slowly to walk. Went to ER. X-ray did not show anything. In ER took Narco 5 and Baclofen. MD thinks that it might not be side effects of vaccine. But I wonder, I never had left lower back pain before. Taking Baclofen and Advil TID since 0101/2021. 01/04 still in pain. increase pain after 6-7 hours after meds. Sitting or standing more than 30 mins Increases pain. Going to see PMD today",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,"Jenumet 1000 mg, multi vitamin, B12, D3, calcium, iron tablets,baby aspirin",,Diabetes,,"Penicillin, statin","['Abdominal pain upper', 'Back pain', 'Gait disturbance', 'Injection site pain', 'Mobility decreased', 'Pain', 'Rhinorrhoea', 'Tenderness', 'X-ray normal']",1,PFIZER\BIONTECH,SYR 918859,AR,24.0,F,This report is being submitted per request of the Dept. of Health to submit all patients who tested positive for COVID19 after receipt of the COVID19 vaccine. No other adverse events reported. The patient tested positive for COVID19 on 12/29/20.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/16/2020,12/29/2020,13.0,PVT,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 918861,MO,41.0,F,"12/31/20 10:30a Vaccine given 10:48a Left the vaccine observation room 11:30a Started feeling warm like maybe my temp was increasing, face was red 12:00p had what felt like an adrenaline spike through my body became hot and jittery feeling. 12:30p The spikes started coming in waves, like a full body hot flash. Was very shaky and my tongue felt itchy and tight; not swollen just tight 12:40p made it home and took Benadryl 1:00p symptoms dissipated, ate a chicken salad sandwich thinking that would help with the jittery feeling. 1:25p The whole body flash came back and the tightness in the tongue increased. 1:27p Called employee health for information on this type of reaction. Wanted to call me an ambulance, I declined. After much discussion they suggested I come back to the vaccination observation room where they have epi, then decided it best that I go to Urgent Care. 1:40 on the way to town I told my husband to take me to the ED instead as my bottom lip felt swollen and tight, and my tongue felt thick like it was a bit swollen too. Was not short of breath, airway did not feel compromised, breathing normal, and heart rate normal. 3:01 Was given 40mg Methylpredinisone (solumedrol) & 20mg famotidine (Pepcid) given- immediate improvement in tongue thickness and swollen lips. 440p 50mg Diphenhydramine (Benadryl), 10mg loratadine (Claritin), & 40mg prednisone given prior to discharge 8:20p Top lip started to swell just before my next dose of Benadryl 8:30p Took next dose of Benadryl, once it kicked in had quick resolution of lip swelling 9:00p joint pain started setting in, was uncomfortable but not too painful 1/121 Joint pain is still present but not uncomfortable. Injection arm a little sore, no redness or swelling at site of injection. Swelling of mouth, face and tongue is persistent as it nears the 4-hour mark for 50mg of Benadryl. 1p ate a couple of bites of chicken fried steak, face is increasing in redness and swelling, and mild tongue swelling. At max dose of Benadryl per box states to only take 6 doses in a 24 hour period. 2p Mouth and face swelling not relieved with Benadryl 2:52p checked into ED for 2nd time. 4:08 Given 10mg dexamethasone (decadron), 20mg famotidine (Pepcid), 10mg montelukast (singular) Swelling improved. 5:54p Potassium low on lab work given 40 mEq of potassium chloride 6:00p discharge with scripts for famotidine, epi pen, montelukast 7:00p taken 25mg of Benadryl 8:20p lips feel mildly swollen again. 8:45p next dose of 25mg Benadryl. Did not have complete resolution of swelling but did improve. Mild hives, swelling of hands and feet. 1/2/21 All joint pain is gone, and injection site pain is only noticeable if someone bumps into my arm. 6a 25mg Benadryl & Pepcid 10a 25mg Benadryl 2p 25mg of Benadryl 3:30pm felt fine all day with only mild swelling and redness to hands, ate chicken nachos. Face became very hot (like my face was too close to the oven when I open it), redness from eyes down, lips swollen, mild itchiness too the tongue but nothing too concerning. 4p 25mg Benadryl I strongly believe the exacerbating factor is eating as all times the symptoms increased in intensity I had just eaten. After discussion with Dr. will be cutting out chicken (chicken was eaten before all 3 instances) and all other meats until complete resolution of symptoms and will avoid any inflammatory foods such as nuts, berries and shellfish. 7p 25mg Benadryl & Claritin taken 7:30p ate a banana, no reaction 8p Singular taken 9:30p put Vaseline on my lips, face & ears flamed hot and swelling and redness followed. 9:45p took 25mg Benadryl 10:25p tongue thick feeling 11p took 25mg Benadryl tongue still feels thick 1/3/21 Fevers 101.6 and chills started in the night Face and lips are permanently swollen and red despite all the meds I?m taking.Lymph nodes are all swollen. I?m too afraid to eat for fear of more swelling while my face is already so swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,PVT,,,,,Oral morphine- rapid heart rate candy coated advil- hives latex- skin reaction pet dander- hives,"['Arthralgia', 'Blood potassium decreased', 'Chills', 'Discomfort', 'Ear swelling', 'Erythema', 'Fear of eating', 'Feeling hot', 'Feeling jittery', 'Hot flush', 'Lip swelling', 'Lymphadenopathy', 'Mouth swelling', 'Nervousness', 'Ocular hyperaemia', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Swelling face', 'Swollen tongue', 'Tongue disorder', 'Tongue pruritus', 'Urticaria']",1,MODERNA,IM 918862,MA,36.0,M,"4:20 Received Vaccine 4:30: Began with feeling flush, c/o ""hot flash"", face visibly red. Advised to remove hat and goggles, given water and a cold cloth. Reported no change. 4:35 Walked to open window, sat in chair. C/O dizziness while sitting, no c/o feeling faint. 77, 138/88, 97%. Remained seated. 4:50 Dizziness resolved, ambulated back to own seat and placed goggles and hat back on, appeared ashen. 77, 97%. C/O feeling of ""moving through mud"" Given 4 oz Orange Juice and advised to sit and wait. 4:55 All symptoms resolved within minutes. Remained under observation and remained stable. 5:00 Released from observation",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Unknown,No known illness,No known chronic illness,,No Known Allergies,"['Dizziness', 'Erythema', 'Flushing', 'Hot flush', 'Sensory disturbance']",7+,MODERNA,IM 918863,NJ,38.0,F,Tachycardia (HR 138 at rest) approximately 10 mins after receiving vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Vitamin C, Vitamin D",None,None,,None,['Tachycardia'],1,MODERNA,IM 918865,MD,38.0,F,"swelling (golf ball size), pain, and redness at injection site. Severe headache and extreme fatigue started morning day after injection and lasted approx. 48 hours. Also a sore throat and some nasal congestion.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,"Adderall XR, Latuda, Ativan",none,none,,"Ceftin, Cipro, Amoxicillin, Darvocet, Codeine, Biaxin, PPD","['Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Nasal congestion', 'Oropharyngeal pain', 'SARS-CoV-2 test negative']",1,MODERNA,IM 918866,KS,40.0,F,"Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as though I was going to pass out. Epi pen was administered when I wasn't able to swallow. Was taken to ER on a stretcher, however they said on the way, I wasn't responding and couldn't open my eyes. Muscles began cramping and loss sensation in limbs. Hands wouldn't open up as they cramped. Blood pressure kept going up and down.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Estradial Welbutrin,,CSF leak (chronic) Ehlers Danlos Sick Sinus syndrome Mast Cell Activation Syndrome,TDAP,"Allergic reaction to TDAP, many unknown reactions that cause me to get rashes.","['Blood pressure fluctuation', 'Chest discomfort', 'Dizziness', 'Dysphagia', 'Eyelid function disorder', 'Muscle spasms', 'Sensory loss', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 918867,MD,60.0,M,"Started with fatigue,. chills, fever up to 100.3, muscle aches, severe chest discomfort , heart rate up to 130 . Is an EMS provider, went to fire house and EKG was normal, just elevated heart rate and BP around 130/80 Fatigue - resulting in lack of eating /appetite",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PUB,Amlodipene 5 m losartin 50mg fenofibrate 160 mg chlorthalidone 25 mg flomax,"none, had COVID illness lab confirmed 5 months ago (August)","HBP, obesity",,none,"['Chest discomfort', 'Chills', 'Decreased appetite', 'Electrocardiogram normal', 'Fatigue', 'Heart rate increased', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 918868,OH,33.0,M,"2 days after vaccination, patient had upper lip swelling, swelling of the top gums in mouth, itchiness, and a rash on both wrists. He took prednisone, Benadryl, and Pecpid and this resolved. Then, 3 days after this (5 days after vaccination), the patient had right eye swelling. He took prednisone and Claritin and this resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/25/2020,2.0,PVT,None,None,None,,None,"['Eye swelling', 'Gingival swelling', 'Lip swelling', 'Pruritus', 'Rash']",1,MODERNA,IM 918869,TX,49.0,M,"Background, I had Covid back at the end of May/beginning of June with 1 week of constant fevers (with 500mg tylenol q6), shortness of breath, fatigue, but no real cough. O2 sats somtimes in low 90's . I am one of the radiology faculty at the hospital I work at. Received my 1st dose of the Pfizer vaccine on Friday Dec 18 at about 21:30. After the injection, I had moderate pain at the site of injection about 6 hours later, not unexpected. However, the next evening, I was feeling fatigued and went to bed at about 7 p.m. For the next three hours, I felt chills and finally at about 10 p.m. I took my temp after I felt that my fever had ""broke"" and temp was 101.9. Used a finger pulse ox just to make sure sats were ok, they were at 97%, but unexpectedly, resting heart rate was 130 bpm. I took some tylenol and called the ER, and they suggested calling the covid hotline pager and coming in if I did not improve. I called the hotline pager, and we discussed things and eventually decided that I should go to the ER as temp remained at 101.6. By the time I reached the ER, my temp was down to 100.8, but pulse still 122 (EKG with no other abnormalities) and BP was 165/100. I had no other symptoms to account another infection. Over the next two hours, vitals became more normal with HR down to 95 to 100, and BP down to 145/85 or so without any other intervention. Sunday, still with some mild low grade temps of 99.8, but heart rate at 85 to 90 (I'm usually at about 80). In the ER, we came to the conclusion that my body mounted a significant immune response to the production of antigens after processing the mRNA given the lack of alternative diagnosis and the improvement of sx without any other intervention besides the 500 mg of tylenol I took before coming in.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,WRK,,Covid 6 months prior (end of may/beginning of June),Fatigue/shortness of breath,,amoxicillin,"['Chills', 'Condition aggravated', 'Electrocardiogram abnormal', 'Fatigue', 'Injection site pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tachycardia']",1,PFIZER\BIONTECH,IM 918870,OH,52.0,F,Patient self-reported that she received her injection subq vs. IM/deltoid as intended. She developed a very large lump at the injection site requiring an ED visit and antibiotics. She also missed one day of work.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,Estrogel daily,unknown,Pt self-reported having a pacemaker,,NKDA,"['Incorrect route of product administration', 'Injection site mass']",1,MODERNA,SC 918871,NE,33.0,F,"Patient received vaccination at 0900 on 12/30/20 Patient began feeling throat tightness and chest heaviness approximately 15 minutes post injection. Symptoms were not severe and did not require medical intervention. At/around 1200 on 12/30/20, patient reports chest heaviness resolved, by mild throat tightness was ongoing At/around 1700 on 12/30/20, patient's legs began feeling itchy but rash/hives did not develop All symptoms resolved by 1900 on 12/30/20 without medical intervention",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Citalopram 20mg daily Metformin 500mg daily,No illnesses at time of vaccination and proceeding month.,Anxiety Polycystic Ovarian Syndrome,30 years old - TdaP vaccination - unknown mfr,Amoxicillin/clavulanate - Rash,"['Chest discomfort', 'Pruritus', 'Throat tightness']",1,MODERNA,IM 918872,AR,50.0,F,Per request of all patients who tested positive for COVID19 after receipt of the COVID19 vaccine must be reported. No other adverse events reported. The patient tested positive for COVID19 on 12/22.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/16/2020,12/22/2020,6.0,PVT,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH,IM 918873,,33.0,F,"lightheaded, sweaty, BP113/77. Administered vaccine supine as patient indicated history of fainting with injections. Symptoms resolved shortly after administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Blood pressure abnormal', 'Dizziness', 'Hyperhidrosis']",1,MODERNA,SYR 918875,WI,51.0,F,"Fever, chills, headache,body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,PVT,Levothyroine,None,None,Shingles,Sulfa,"['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 918876,ID,46.0,F,"Immediately after had a weird taste in my mouth felt dizzy and nauseous and got extreme cotton mouth?this lasted about 3-5 minutes. Continued to have intermittent cotton mouth throughout the day Within 7 hrs of getting the vaccine the back of my tongue hurt extremely bad and I acquired canker sores on my tongue and extreme fatigue. 12 hrs after I was racked with body aches, chills, fever, dizziness, nausea, headache. I did go to work for a couple of hours and was sent home just kept getting worse even after Tylenol Proceeded to have everything you can get with covid except a cough.. tight chest no real taste and all the above symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,PVT,,,,Influenza Vaccine (Unspecified),,"['Ageusia', 'Chest discomfort', 'Chills', 'Dizziness', 'Dry mouth', 'Fatigue', 'Glossodynia', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Taste disorder']",1,MODERNA,IM 918877,MO,51.0,F,"Swelling at site, Red and hot to touch, Pain, Lumped up, Was told to go in to be seen. Place on antibiotic, Went in on 1/2/2021. Swelling not so much now, still red and hot to touch, redness has expanded.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,12/31/2020,7.0,PVT,,,,,"KEFLEX, ERYTHROMYCIN, PROPRANOLOL, LISINOPRIL, AMLODIPINE, BEE STINGS, STERI STRIPS, ROEMARY OIL","['Injection site erythema', 'Injection site induration', 'Skin warm', 'Vaccination site pain', 'Vaccination site swelling']",1,MODERNA,IM 918878,LA,68.0,F,None,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,,,,,,['Unevaluable event'],2,PFIZER\BIONTECH,SYR 918879,NY,52.0,F,"I started to develop a fever 2-3 days after the first vaccine. My fever continued for 9 days straight, even though i was taking antipyretic",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/19/2020,2.0,PVT,"Tamoxifen, probiotic, biotin",,Breast CA dx 2019,,PCN,"['Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 918880,CA,32.0,F,"Moderna COVID-19 Vaccine: Vaccine received at 1735; tachycardia in 120s, shakiness, dizziness at 1740; chest pressure at 1745, went away then returned at 1815 and lasted until 2330 BP 156/91 HR 120s @1805 Sent to ER 1820 BP 167/99 HR 120s @1825 BP 142/87 HR 100s @1845 BP 137/76 HR 90s @1920 BP 126/75 HR 80s @ 1955 Benadryl 25 mg and Tylenol 1000 mg taken at 1700 prior to injection Second dose of Benadryl 25 mg taken at 1800",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,Benadryl 25 mg PRN Tylenol 1000 mg PRN,None,Asthma,,"Ibuprofen, lyrica, nuts, tomato, corn, wheat, oats","['Blood pressure increased', 'Chest discomfort', 'Dizziness', 'Electrocardiogram normal', 'Tachycardia', 'Tremor']",1,MODERNA,IM 918881,MI,25.0,F,"Difficulty Breathing, fast heartbeat, dizziness and weakness. Body aches and nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/26/2020,0.0,PVT,None known,none known,None known,,None known,"['Asthenia', 'Dizziness', 'Dyspnoea', 'Heart rate increased', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,IM 918882,IA,36.0,F,"She states that she had her COVID-19 vaccine on 12/27. On 1/1/2020 her husband noticed a rash on her arm. She states that over the weekend it has gotten larger and is estimating that it is 3.5""x2"" in size this morning. She feels like it is a bit warm to the touch, but is not painful and denies any pruritus. She does think that her arm is a ""bit more swollen"" then her other, but not significant. Initially after the vaccine she did not have any other symptoms than a ""typical"" sore arm for 2 days. Instructed the employee to take a 2nd generation antihistamine, and to use NSAIDs and ICE to manage symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/27/2020,01/02/2021,6.0,WRK,,,,,,"['Pain in extremity', 'Rash']",1,MODERNA,IM 918883,MD,24.0,F,"Started within a day of injection. I experienced the following symptoms for the next few days: headache, diarrhea, injection site soreness, fatigue, body aches, chills, feeling unwell, stomach pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,Levothyroxine Sodium 50 mcg Larin Fe 28 day birth control Tylenol 500 mg,,Diabetes Type 2 Polycystic Ovarian Syndrome Hashimoto's Disease Hypothyroidism Asthma,,Cashews Topical clindamycin,"['Abdominal pain upper', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Pain']",1,PFIZER\BIONTECH,IM 918884,MO,30.0,F,"Pfizer-BioNTech COVID-19 Vaccine: On the day I received the first does of the vaccine, I felt fine until about 6 hours later. At that point, I started to get very dizzy and lightheaded. Every time I opened my eyes, everything was spinning. This lasted four about 3-4 hours. I kept breaking out into sweats. I had a horrible headache for about 4 days straight. I am still continuing to having headaches. I am still having hot flashes and dizziness episodes at times that go away after about a few minutes. Two days ago, I stated to developing swelling in my hands with achy joints which has not gone away.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,birth control,none,none,,none,"['Arthralgia', 'Dizziness', 'Headache', 'Hot flush', 'Hyperhidrosis', 'Peripheral swelling', 'Vertigo']",1,PFIZER\BIONTECH,SYR 918885,TX,51.0,M,"After 12 hours, I had body chills, body aches, slight fever and a massive headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,OTH,None,None,None,,No,"['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,MODERNA, 918886,CA,40.0,M,Right hand pain in center of palm. Started the very next day of vaccine. First three days was very painful and radiated up to just past the wrist. Now its just sore.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,,stomach flu one week prior,"BPH, Sleep apnea",,,"['Arthralgia', 'Pain', 'Pain in extremity']",1,MODERNA,IM 918887,AZ,35.0,F,Rash at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/02/2021,,PVT,none,none,none,,none,['Injection site rash'],1,MODERNA,IM 918888,CA,30.0,M,6 day history R sided chest rash w/ skin hypersensitivity consistent with shingles rash. Received covid vaccine 1.5 days before. Seen by PMD over telehealth appt and dx with shingles. Had VZV at 5 yo. No prior vaccine for VZV.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,,,,,Nkda,"['Herpes zoster', 'Hyperaesthesia', 'Rash']",1,PFIZER\BIONTECH,IM 918889,MD,23.0,F,Arm pain at the injection site that started several hours after the injection. The next day she began having pain in her armpit and under her collar bone on the same side as the injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Axillary pain', 'Injection site pain']",1,PFIZER\BIONTECH,IM 918890,CA,60.0,F,"12/22 site of injection red, swollen, painful, harden, warm to touch,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,PVT,multi vitamin Centrium 50+ hydrochlorothiazide metformin Humulin insulin Regular insulin pravastatin,none,"diabetes , hypertension , high cholesterol,",,Nkda,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA,IM 918891,FL,33.0,F,"Day 0-4: arm soreness Day 8: onset of bulls-eye rash at injection site of left arm. Rash is raised, erythematous, firm. Associated with several 1-3 cm enlarged tender axillary lymph nodes. Day 9-11: severe left sided headache not responded to over-the-counter analgesics. Headache resolved on Day 12. Day 9-13: ongoing fluctuations in left arm rash and adenopathy. By day 13, adenopathy mostly resolved. Rash persists.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/30/2020,8.0,WRK,None,None,None,,Shellfish allergy. No drug allergies.,"['Headache', 'Induration', 'Injection site rash', 'Lymph node pain', 'Lymphadenopathy', 'Pain in extremity', 'Rash erythematous', 'Rash papular']",1,MODERNA,IM 918892,NY,50.0,F,"About 1.5 hours after dose administration, patient began to feel lightheaded and weak, unable to stand up. He then noticed a rash on his forehead, chest, arms and back of neck. He had no swelling of the lips, tongue or throat. No shortness of breath or wheezing noted. VS 157/110, 101, 20, 97.7. Pulse ox 99% on room air. No acute distress, but a little anxious. No oropharyngeal erythema or swelling seen. Lungs clear to auscultation. Skin revealed red macular rash on the face. Other areas had faded. Benadryl 50mg po given with good effect. Weak feeling subsided quickly and hives began to fade. Repeat vitals over 30 minutes were largely unchanged. He was allowed to go home with instructions to contact his PMD and to use Benadryl 50mg po Q4H PRN. If he develops any signs/symptoms of anaphylaxis he should call 911.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,Influenza vaccine has made him feel lightheaded.,,"['Anxiety', 'Asthenia', 'Blood pressure increased', 'Dizziness', 'Heart rate increased', 'Rash', 'Rash macular']",1,MODERNA,IM 918893,NC,26.0,F,"Day of vaccine: Headache/migraine with light sensitivity, severe nausea (constant need to throw up for 4-5 hours), vomiting, body aches. Day after: Shakiness, dizziness, slight nausea - unable to work",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PHM,"Taytulla, aleve",Minor cold,None,,None,"['Dizziness', 'Headache', 'Migraine', 'Nausea', 'Pain', 'Photophobia', 'Tremor', 'Vomiting']",1,MODERNA,SYR 918894,CA,83.0,F,"Patient reporting sore arm, diarrhea and nausea every once in a while since 1/2/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,"Yes, regular medications",,,,,"['Diarrhoea', 'Nausea', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 918896,SC,50.0,F,"1 hour after administration, patient's lips tingling and she experienced swelling as well. Patient received 25mg diphenhydramine and was observed for 30 mins. Symptoms resolved over 30 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,olmesartan/HCTZ,,controlled HTN,,"PCN, chocolate, lemons","['Lip swelling', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 918897,CA,68.0,M,"? 10:15 while he was still waiting outside he had some anxiety and was worried he had a panic attack as he has had a lot going on in his life recently. No tachycardia as he was checking his Apple Watch and no other symptoms. ? 10:20 he drove home and called his wife can kept her on the call as he drove. He them experienced some mild tingling in his ears, face and lips. ? 10:30 he got home and his lips were mildly swollen, more so on the upper lip, not as much on the lower lip. ? 10:45 he took an Allegra and about 30-40 minutes afterwards the lip swelling started to calm ? 5:45pm I spoke with him. He said he has no more symptoms. A little tired perhaps from the day or the Allegra (though it doesn?t cause too much drowsiness compared to Benadryl) ? He also reported he had a flu and shingles vaccine back in early November so it has been more than a month.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,,,,,,"['Anxiety', 'Fatigue', 'Lip swelling', 'Paraesthesia', 'Paraesthesia oral']",UNK,PFIZER\BIONTECH,IM 918898,CA,33.0,M,"Broke out in Itchy bumps around arms, legs and stomach",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/28/2020,7.0,PVT,,,,,,['Rash pruritic'],1,PFIZER\BIONTECH,SYR 918899,IL,48.0,M,"I had right sided headache for the first two days, then resolved. The right sided headaches recurred along with right tongue numbness initially on 12/29/2020. The symptoms worsen on 12/31/2020 and severe on 1/1/2021. I was initially started on Valtrex thinking it maybe due to shingles but soon with the right sided facial paralysis, it was obvious it was Bell's Palsy and was started on steriods on 1/1/21 and also received acupuncture treatment on 1/2/21 which significant help improve the symptoms. I still have some residual weakness of the right eye with some tearing and mouth weakness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,Valsarten and Cardizem,none,hypertension,,none,"['Extraocular muscle paresis', 'Facial paralysis', 'Headache', 'Hypoaesthesia oral', 'Lacrimation increased']",1,PFIZER\BIONTECH,IM 918900,,30.0,M,6 day history of R sided chest rash w/ skin hypersensitivity and pain of R upper body consistent with shingles rash. Received vaccine 1.5 days prior. Went to PMD video telehealth appt and dx with shingles. Had VZV at 5yo. No prior vaccination for VZV.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,,,,,Nkda,"['Dermatitis allergic', 'Herpes zoster', 'Pain of skin', 'Rash']",1,PFIZER\BIONTECH,IM 918901,MD,35.0,F,Lightheadedness and heart palpatations,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,WRK,,,,,,"['Dizziness', 'Palpitations']",1,PFIZER\BIONTECH,ID 918902,NY,83.0,F,"Chills, Vomitting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,SEN,,,,,,"['Chills', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 918903,GA,32.0,F,"RASH ROUGHLY THE SIZE OF A BASEBALL, RAISED RING AROUND THE EDGE, VERY ITCHING SLIGHTLY WARM TO TOUCH. STILL PRESENT AT 10 DAYS POST VACCINE",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/28/2020,4.0,PHM,"BIRTH CONTROL, MULTIVITAMIN",NONE,NONE,,BLUE DYE,"['Rash', 'Rash papular', 'Rash pruritic', 'Skin warm']",1,MODERNA,IM 918904,CA,32.0,F,"Itchy, swollen reddened arm at sit of injection, starting on 6th day after injection. Left armpit axillary swollen lymph node",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/01/2021,6.0,PVT,Spironlactone Doxycyline,No,Acne,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Lymphadenopathy']",1,MODERNA,IM 918906,CA,38.0,F,vomiting diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,UNK,,,,,,"['Diarrhoea', 'Vomiting']",1,PFIZER\BIONTECH,SYR 918908,CA,56.0,F,"Moderna COVID 19 Vaccine: Developed left arm achiness, site swelling and pain radiation into back of neck. 1/3/2021 during the night developed chills, achiness, back pain, general malaise. As of time of this report 1/4 symptoms continue... Was feeling 100% healthy at time of vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PVT,Tenormin,None,"None However, History of symptomatic Covid 19 positive 10/21/2020.",,None,"['Back pain', 'Chills', 'Injection site pain', 'Injection site swelling', 'Malaise', 'Pain', 'Pain in extremity', 'Vaccination site swelling']",1,MODERNA,IM 918909,MA,20.0,F,"Heart Palpitations, still on going. High fever Sweats Chills Shakes",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/30/2020,29.0,PVT,,,,,"Dust bites, dogs, pollen, trees","['Chills', 'Hyperhidrosis', 'Palpitations', 'Pyrexia', 'Tremor']",UNK,MODERNA,SYR 918910,IA,46.0,F,"On day 1 (12/23/2020) after receiving her vaccine she states her arm was sore. On 12/31/2020 she developed Pruritus. On 1/1/2021 a baseball size welt developed. She used ice and started taking Zyrtec. She does not have any other symptoms. On 1/2/2020 the baseball size welt decreased, but 2 more welts developed that were thumb print size.. Today she does feel like the redness and swelling are getting better.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/31/2020,8.0,WRK,,,,,,"['Pain in extremity', 'Pruritus', 'Urticaria']",1,MODERNA,IM 918911,MI,47.0,F,"Temp, diarrhea for 4 hrs, malaise, bad headache , insomnia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,WRK,None,None,None,,None,"['Diarrhoea', 'Headache', 'Insomnia', 'Malaise']",1,PFIZER\BIONTECH,IM 918912,TN,37.0,F,Headache x 3 days (very uncommon for patient) with only minimal relief from naproxen and acetaminophen dosed multiple times Fatigue (slept more than normal),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/31/2020,4.0,PVT,"Women's multivitamin daily, cholecalciferol 1000 IU daily",,,,,"['Fatigue', 'Headache', 'Hypersomnia']",1,PFIZER\BIONTECH,IM 918914,OR,41.0,M,"Employee received the vaccine at 0805, reported at 0812 that he was dizzy, lightheaded, nauseated and diaphoretic. Employee assisted to cot to lie down. Skin pale, continued to be diaphoretic, respirations in the 20's, BP 115/82, HR 110, O2 98% on RA, denied any difficulty breathing, no coughing or evidence of throat tightening, no sign of any swelling at vaccination site, no rash. Code called overhead, Code team arrived. No medications given at time in clinic. Near syncopal episode, No anaphylaxis. Employee taken to ED for further evaluation and observation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Lisinopril, Metoprolol, Metformin, Eloquis",none,"Hypertension, DM, Afib Chronic",,NKDA,"['Cardio-respiratory arrest', 'Dizziness', 'Hyperhidrosis', 'Nausea', 'Pallor', 'Presyncope']",1,MODERNA,IM 918915,,42.0,F,"After patient received an injection, patient developed fever, body aches, body chills, and injection site is red and swollen. Patient also mentioned that her arm pit area is also swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Chills', 'Injection site erythema', 'Injection site swelling', 'Oedema peripheral', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 918916,WI,59.0,M,Patient received vaccine that may not be fully effective due to room temperature storage for more than 12 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/26/2020,0.0,PVT,,,,,SMX/TMP,['Product storage error'],1,MODERNA,IM 918917,CA,35.0,F,"? After her shot in the afternoon, she sat outside for 15 minutes. She came back in and said her throat is warm and scratchy, and her left hand felt cold. ? I escorted her over to the ER and she was checked in. I then went right back to EOHD since we were so busy. ? Around 4pm in the afternoon after we closed EOHD, I went back to the ER. She was recovering and doing fine. Her ER nurse did have a question about receiving the 2nd dose, and I provided the same answer that Dr. provided to other Dr. about taking an Allegra 30 minutes before the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,PVT,,,,,,"['Feeling hot', 'Oropharyngeal discomfort', 'Peripheral coldness']",1,PFIZER\BIONTECH,IM 918918,NY,90.0,F,"Chills, Vomiting. Malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,SEN,,,,,,"['Chills', 'Malaise', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 918920,CA,44.0,F,"Muscle pain all over, fatigue and hot/cold flashes. Patient also reports feeling very thirsty.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/03/2021,3.0,WRK,,,,,,"['Fatigue', 'Feeling of body temperature change', 'Hot flush', 'Myalgia', 'Thirst']",UNK,MODERNA, 918921,WY,49.0,F,"Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea. Symptoms are ongoing. Also, complaints of insomnia (ongoing), joint pain (day after vaccination), right lower quadrant pain (first night after vaccination), weakness (for 3 days after vaccination), moderate muscle pain at injection site (resolved after 48 hours), night sweats (ongoing).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,OTH,"Effexor, levothyroxine, atorvastatin, calcium w vitamin D, turmeric, pomegranate, melatonin",none,"neutropenia, hypothyroidism, hypercholesterolemia, depression",,"Imitrex, inapsine, demerol","['Abdominal pain lower', 'Arthralgia', 'Asthenia', 'Dizziness', 'Injection site pain', 'Insomnia', 'Nausea', 'Night sweats']",1,PFIZER\BIONTECH,IM 918923,NY,75.0,M,"Patient had multiple episodes of vomiting but has a history of dysphagia, patient also reported generalized weakness in bilateral lower extremities. Was sent to the ER and discharged",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,OTH,,,,,,"['Muscular weakness', 'Vomiting']",UNK,MODERNA,IM 918924,VT,35.0,F,"red hot rash appeared 1 week after received vaccine. it was slightly itchy. Rash grew slightly on 2nd day but decreased in redness, still hot. Third day size and redness decreased as well as temperature. 4th day gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/31/2020,7.0,PVT,Gummy Multivitamin,none,none,,"Penicillin, Sulfa. Have reactions to raw fruits and vegetables including apples, peaches, pears, pears, snap peas, almonds (w/ skin)","['Feeling hot', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 918925,WI,54.0,F,"Patient had some dizziness and flushing post vaccine administration, but she declined calling the rapid response team. This resolved within 5 minutes without intervention. Closely monitored for 30 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,none per pt,denies,denies,pt reported feeling flu symptoms following flu vaccine,unable to determine,"['Dizziness', 'Flushing']",1,MODERNA,IM 918926,NY,40.0,F,"On Dec 29th, I developed bilateral loss of sensation in my thumb and first 3 fingers, with loss of dexterity. It improved somewhat over the next 45 minutes, but I continue to have loss of sensation in all 10 fingertips, worse in both thumb and 5th digits.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/29/2020,10.0,PVT,"Magnesium, Vit D, Acetyl L-Carnitine, Probiotic, Flonase",None,None,,None,"['Fine motor skill dysfunction', 'Hypoaesthesia', 'Magnetic resonance imaging spinal normal', 'Sensory loss']",1,PFIZER\BIONTECH,IM 918927,KS,39.0,F,"Nausea, chills, arthralgia/myalgia, low-grade fever: all symptoms began 16 hours after vaccine and subsided within 24 hours of vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/15/2020,12/16/2020,1.0,PVT,Synthroid Adderall XR Vitamin D2,,Hypothyroidism,,,"['Arthralgia', 'Chills', 'Myalgia', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,IM 918928,OH,64.0,F,"Anxiety attack lasting 2 hours,. Took some benadryl and wellbutrin. Within 40 minutes calmed down enough, until the next day started feeling shaky and anxious again..called Dr. at home. She says to take my wellbutrin in the morning as well as my evening dose and benedryl every 4 hours. Has been good since then.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,"Ability 5 mg daily, wellbutrin 150 mg daily",None,Depression,,"Sulfa, quinolones","['Anxiety', 'Nervousness']",1,MODERNA,IM 918929,IL,21.0,F,"Fever greater than 100 degrees F, full body muscle aches, chills, sore throat, tender armpit (left)- 12/27/2020 (all day) Itchy, blanched, swollen, hard, warm patch on left arm 4.5"" x 3"" with surrounding redness and tender armpit- 01/02/2021- present",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/27/2020,1.0,PVT,"Sprintec (birth control), Methimazole, Ferrous sulfate",,,,Sulfa drugs,"['Axillary pain', 'Chills', 'Erythema', 'Induration', 'Myalgia', 'Oropharyngeal pain', 'Pallor', 'Peripheral swelling', 'Pruritus', 'Pyrexia', 'Skin warm']",1,MODERNA,IM 918931,CA,59.0,F,"Patient received the covid vaccine on 12/30/2020. Tolerated the vaccine without problem. c/o new onset of ""stomach pain"" at the RLQ. Unable to walk starting on Jan 3rd. Pain persists today. Denies fever, HA, Dizziness, cough, nausea, vomiting, diarrhea, or constipation. She has reached out to her rheumatologist. She noticed the pain occurred after she self administered the Taltz injection on 12/31/2020. She is concerned about the drug-to-drug interactions with the vaccine. Covid test on 12/23/2020 was negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,,,UNK,"MTX, levothyroxine, Taltz inj, folic acid, Lisinopril",,Psoriatic arthritis,,Contrast dye,"['Abdominal pain lower', 'Gait inability', 'SARS-CoV-2 test negative', 'Self-medication']",UNK,PFIZER\BIONTECH, 918932,KS,51.0,F,"My arm was so sore I could not hardly move it, starting approx. 6 hours after injection. Now 5 days after injection still quite sore. Entire upper arm, approx. 7""x4"" area erythema and hot to touch (even through clothing). Redness started a couple hours after injection. Now 5 days after vaccine red area is approx. 3""x3"". At injection site, approx. 1""x1"" hard bump that is still present 5 days after vaccine Area of upper arm where injection given, severe itching, which continues now 5 days after vaccine. Approx 9 hours after injection and continuing for approx. 36 hours, body aches and joint pain. I took Tylenol and Benadryl for 48 hours after vaccine reaction first noted.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Gabepentin Tizanidine Phenergan Prilosec OTC Meloxicam Isosorbide,Non,"Fibromyalgia Arthritis (hips, Low back) Asthma Microvascular disease Migraines","Shingles, 2019",Floroquinolines Dilaudid Steroids Tramadol,"['Arthralgia', 'Erythema', 'Injection site induration', 'Injection site mass', 'Injection site pruritus', 'Mobility decreased', 'Pain', 'Pain in extremity', 'Skin warm']",1,MODERNA,IM 918933,WI,50.0,F,Patient received a dose of vaccine that may be less than fully effective due to storage at room temperature for more than 12 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/31/2020,5.0,PVT,,,,,,['Product storage error'],1,MODERNA,IM 918934,NY,40.0,F,"Woke up during the night (12/24) with a sore throat, felt like it was closing and called 911. Did not go to ER. took Benadryl with relief. Injection site hot with an extremely sore arm the first day which is better now. Fatigue, achy all over persists taking tylenol and ibuprofen for symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,PVT,,,,,,"['Fatigue', 'Injection site pain', 'Injection site warmth', 'Oropharyngeal pain', 'Pain', 'Throat tightness']",1,MODERNA,IM 918935,NE,33.0,F,"Rash on chest, neck and arms Nausea, loss of appetite Severe Headache Extreme Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,OTH,Prenatal Vitamin,None,None,,Pineapple,"['Decreased appetite', 'Fatigue', 'Headache', 'Nausea', 'Rash']",1,MODERNA,IM 918936,TN,54.0,F,"Injection site became very red, swollen, hot to the touch and soreness returned 10 days after vaccination. Called my healthcare provider and he prescribed Cephalexin 500 MG to be taken three times a day for seven days. Three days after starting antibiotic treatment, redness and swelling were gone along with the fever in the arm. Healthcare provider suggested I not take the second dose. I would like an opinion from your facility.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/01/2021,9.0,PUB,clonazapam,none,none,,none,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 918937,OH,30.0,F,Pain at the injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Prenatal Iron Vitamin D,None,None,,None,['Injection site pain'],1,MODERNA,IM 918938,AZ,28.0,F,pt began to feel tingling in her left arm and her throat. she felt tightness in the throat and voice was hoarse. she felt ligh headed like she might pass out but did not pass out. she felt chest discomfort with deep breath.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,depo shot,none,no medical conditions,,amoxicillin,"['Chest discomfort', 'Dizziness', 'Dysphonia', 'Electrocardiogram normal', 'Full blood count normal', 'Metabolic function test normal', 'Paraesthesia', 'Pharyngeal paraesthesia', 'Throat tightness']",1,MODERNA,IM 918939,,21.0,F,"Low grade fever, chills, head ache, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,UNK,"Zoloft, Microgestin",None,None,,"Prozac, nickel","['Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,SYR 918940,PA,33.0,F,I am currently experiencing a swollen lymphnode in my left armpit which is the same arm that I received the vaccine in. This first presented around 11:00pm on Saturday 01/02/2021. I received my first dose of the moderna covid-19 vaccine on 12/28/2020. I did look on Moderna's website for further reaction information and it states that 4% of their test group reported this same symptom 5 to 7 days after first injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,WRK,Junel birthcontrol,no illness,asthma,,no known allergies,['Lymphadenopathy'],1,MODERNA,IM 918941,NY,43.0,F,"Vaccinated 12/19, had injection site pain for 2 days. Then on 12/25, developed cough, congestion, shortness of breath, fatigue, muscle aches, chills, and headaches. Starting 12/26, managed symptoms with albuterol 6 times/day. By 12/28 symptoms improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/25/2020,6.0,PVT,,,,,,"['Chills', 'Cough', 'Dyspnoea', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Respiratory tract congestion', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH,IM 918942,NY,30.0,F,"First day, shooting pain up the back of the arm. Next day noticed a firm lump 2"" from injection site, tricep area with redness and swelling, tenderness and pain all at inj. site. Marked for size and by 12/26 the lump, redness, swelling had increased in size. Tylenol with no relief, applied heat to lump made it worse. Took Benadryl x 3 doses and symptoms are much improved. Headache on 12/25-12/26, Fatigue x 3 days, muscle pain in shoulders/neck.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,,,,,,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Pain', 'Pain in extremity']",1,MODERNA,IM 918950,LA,41.0,F,"12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/24/2020,1.0,PVT,,,,,,"['Asthenia', 'COVID-19', 'Chest X-ray', 'Cough', 'Dizziness', 'Dyspnoea', 'Feeding disorder', 'Full blood count', 'Headache', 'Hypoaesthesia', 'Influenza like illness', 'Influenza virus test negative', 'Injection site pain', 'Injection site swelling', 'Metabolic function test', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Unresponsive to stimuli', 'Urine analysis', 'Vomiting']",1,PFIZER\BIONTECH,IM 918952,LA,43.0,F,"On day 4 post vaccine, 12/27/2020, patient began with head and neck soreness, a migraine, and nausea/vomiting. Patient saw MD on 12/30/2020, MD stated patient had inflammatory response to the vaccine. Patient received a steroid injection. Patient states she feels better after steroid injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/27/2020,4.0,PVT,,,,,,"['Headache', 'Inflammation', 'Migraine', 'Nausea', 'Neck pain', 'Vomiting']",1,PFIZER\BIONTECH,IM 918953,LA,56.0,F,"Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. On day 2, patient experienced shills, diarrhea, headache, weakness that lasted 3.5 days. Reports follow-up with primary physician.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/22/2020,1.0,UNK,,,,,,"['Asthenia', 'Chills', 'Diarrhoea', 'Headache', 'Injection site pain', 'Injection site swelling']",1,PFIZER\BIONTECH,IM 918964,FL,68.0,F,"lost peripheral vision; vascular spasms which could be impacting blood flow to the optic nerve; Loss of vision in both eyes for approximately 10 seconds; Pinpoint vision with straight lines / narrowing of vision like pinpoint straight black lines or black straws then everything went black; 3 or 4 episodes of memory loss; ice cold sensation around her head; head felt strange; low voltage electricity going through her head / felt like a knife stabbing on the left side of her head and then on the right side of the head; chickenpox can lie dormant in the termporal lobe of the brand / Shingrix may have disturbed that.; headache; Body aches; Sore, aching arm; This case was reported by a nurse via call center representative and described the occurrence of loss of vision in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (shingles in the early 2000s, between 2004-2006.). Previously administered products included Zostavax. On 7th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 7th November 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, feeling cold, feeling abnormal, head discomfort and chickenpox. On 8th November 2020, the patient experienced memory loss. In November 2020, the patient experienced headache and general body pain. On 11th December 2020, the patient experienced loss of vision (serious criteria GSK medically significant) and abnormal vision. On an unknown date, the patient experienced peripheral vision defective and spasms. On 11th December 2020, the outcome of the loss of vision was recovered/resolved. On an unknown date, the outcome of the pain in arm, general body pain and abnormal vision were recovered/resolved and the outcome of the headache and memory loss were not recovered/not resolved and the outcome of the feeling cold, feeling abnormal, peripheral vision defective, spasms, head discomfort and chickenpox were unknown. The reporter considered the loss of vision, pain in arm, headache, general body pain, memory loss and abnormal vision to be related to Shingrix. It was unknown if the reporter considered the feeling cold, feeling abnormal, peripheral vision defective, spasms, head discomfort and chickenpox to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. Patient had shingles in the early 2000s, between 2004-2006. Patient received Zostavax in 2011. It was reported that patient received the second dose of Shingrix on 7th November 2020 and experienced sore, aching arm (occurred the same day and lasted approximately 3-4 days),severe headache (began day second dose received on 11/7/2020 and was ongoing), body aches (began day of second dose, on 11/7/2020), 3 or 4 episodes of memory loss(began the day after receiving the second dose, on 11/8/2020. Last occurrence on 12/20/2020) Patient also experienced pinpoint vision with straight lines (occurred a week prior to 12/18/20), and loss of vision in both eyes for approximately 10 seconds (occurred a week prior to 12/18/20). HCP suggested that symptoms were related to Shingrix. It was also stated that patient experienced vision loss she initially felt like there was a low voltage electricity going through her head.and lost peripheral vision also regarding forward vision, she experienced a narrowing of vision like pinpoint straight black lines or black straws then everything went black,all of this all lasted about 10 seconds in total. Patient also felt heard strange. Patient did some testa like CT scan of her brain with and without contrast dye and it came back negative and had a CT scan with contrast dye of her carotid and it came back negative. She was cleared by Cardiac and she was having an MRI with contrast dye. On 7th November 2020 patient also experienced an ice cold sensation around her head which lasted for maybe a week or less, on same night felt like a knife stabbing on the left side of her head and then on the right side of the head. Physician mentioned she could be having vascular spasms which could be impacting blood flow to the optic nerve and also mentioned that chickenpox can lie dormant in the termporal lobe of the brand and that Shingrix may have disturbed that. The reporter consented to follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,11/07/2020,11/01/2020,,UNK,,,"Medical History/Concurrent Conditions: Shingles (shingles in the early 2000s, between 2004-2006.)",,,"['Amnesia', 'Blindness', 'Cardiac monitoring normal', 'Computerised tomogram head normal', 'Computerised tomogram normal', 'Feeling abnormal', 'Feeling cold', 'Head discomfort', 'Headache', 'Magnetic resonance imaging', 'Muscle spasms', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Scan with contrast normal', 'Varicella', 'Visual field defect', 'Visual impairment']",2,GLAXOSMITHKLINE BIOLOGICALS,IM 918966,IL,40.0,F,"Headache; fatigue; muscles aches; Fever/ 103.6/100.8/""102 something""; Dizziness; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, expiry date: Mar2021, via an unspecified route of administration from 20Dec2020 at a single dose (dose unknown, by injection once) for covid-19 immunization. Medical history included multiple sclerosis (MS) from 2015 and ongoing. The patient's concomitant medications were not reported. The patient previously took ocrevus for multiple sclerosis. She had COVID in August, and got antibody testing, as the medication she was on (ocrevus) for MS knocked out antibodies, so she received the vaccine. The patient spiked a fever of 103.6. She couldn't get out of bed all day and she started having dizziness and headache yesterday, which got progressively worse, and last night she had fever of like 100.8, muscles aches and fatigue, and she woke up this morning and her temperature was ""102 something"", and she took ibuprofen. She stated that she then got out of bed, as she could hardly get out of bed before or she would pass out, and now her temperature is 103.6, and she has never had it that high before. The dizziness started soon after vaccine. It is all over the place, when she stands, she is incredibly dizzy, but is ok now that she is sitting. She added that she has MS, so dizziness was not abnormal for her. The headache started soon after vaccine; it comes and goes, it goes away and comes back. For the muscle aches and fatigue, they got a lot worse, but was ok now, the Ibuprofen is kicking in. She had stayed in bed all day, then her temperature was 103.6, she had finally got out of bed and took her temperature and ibuprofen. Outcome of events fever, fatigue, myalgia was not recovered whereas the outcome of other events was unknown. No follow-up attempts are possible. No further information is expected. The information on the batch/lot number was obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/20/2020,0.0,UNK,,MS,,,,"['Antibody test', 'Body temperature', 'COVID-19', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 918967,,,F,she got the COVID 19 vaccine on the 16Dec2020 and got tested positive on the following day; she got the COVID 19 vaccine on the 16Dec2020 and got tested positive on the following day; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got the COVID 19 vaccine on the 16Dec2020 and got tested positive on the following day (17Dec2020). She is scheduled to take her second dose on 20Jan2021. The patient wanted to know what Pfizer recommendations are. Outcome of the event was unknown. That information on the lot/batch number has been requested.; Sender's Comments: A causal role of BNT162B2 would seem unlikely based on the temporal gap between the vaccination and the event onset.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/17/2020,1.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 918968,NY,54.0,F,"(L) increased arm soreness, sl. redness resolved after 2 days, Dec 31st swelling redness @ site 1/2 dollar size. progressed to saucer size over weekend of 1/1 - 1/3 Less swelling, increased redness and size",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/31/2020,8.0,PVT,"Bisoprolol 2.5 mg po qd, Tricor 145mg po qHs, vit D 2000 IU QD, Protonix 20mg po qd, carafate 1gm po",decreased cold symptoms early in Dec COVIDE,"M6US, HTN, Diverticulosis, SVT, increased triglycerides",Mantoux about 15 years,"Ceclor, sulfa, Lorabid, Ultram, parafon forte, honey","['Erythema', 'Pain in extremity', 'Swelling']",1,MODERNA,IM 918969,IL,48.0,F,"Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; Pain remains 7/10 in shoulder blade and arm; Still do not have full AROM 23+ hours after injection; muscle spasms around left shoulder blade 4-5 hours later; 130 resting heart rate 6 hours after; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees/ Pain remains 7/10 in shoulder blade and arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), intramuscular in the left arm on 21Dec2020 13:15 at a single dose for COVID-19 immunization. Medical history included partial motor seizures face. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included lisdexamfetamine mesilate (VYVANSE 40 mg), escitalopram oxalate (LEXAPRO 10 mg), brivaracetam (BRIVIACT, 100 mg). On 21Dec2020 4pm, within a couple hours severe pain in left arm at injection site and deltoid, muscle spasms around left shoulder blade 4-5 hours later, 130 resting heart rate 6 hours after, burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees. On 22Dec2020, by 9 am this morning back to 90 degrees shoulder flexion and abduction with pain. Pain remains 7/10 in shoulder blade and arm. Still do not have full AROM 23+ hours after injection. The patient was not hospitalized for the events and did not receive any treatment for the events. The events were reported as non-serious. The vaccine was administered in a workplace clinic. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel. Information regarding lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,WRK,VYVANSE; LEXAPRO; BRIVIACT,,Medical History/Concurrent Conditions: COVID-19; Focal motor seizures,,,"['Arthralgia', 'Chest pain', 'Heart rate', 'Heart rate increased', 'Joint range of motion decreased', 'Muscle spasms', 'Pain assessment', 'Pain in extremity', 'Vaccination site movement impairment', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 918970,MA,,F,"Chills; fever; fatigue; tiredness; nausea; Little bit of vomiting; This case was missing the following minimum criteria: there is unspecified event. Upon receipt of follow-up information on (22Dec2020), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other HCP reporting for herself. A 51-year-old female patient received bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced the following symptoms chills, fever, fatigue, tiredness, nausea, little bit of vomiting, the outcome of all the reported events was unknown. The patient stated that before receiving the vaccine, she was in contact with her husband who discovered to be positive to COVID 19. The patient is now concerned because she does not know if the symptoms she is experiencing are caused by the vaccine or by the illness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,,,UNK,,,,,,"['Chills', 'Fatigue', 'Nausea', 'Pyrexia', 'Vomiting']",UNK,PFIZER\BIONTECH, 918971,PA,58.0,M,"chills; fever; bodyaches; fatigue; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 24Dec2020, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other HCP. A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ej1685), via intramuscular in left arm on 22Dec2020 14:45 at first single dose, via intramuscular in left arm on 22Dec2020 15:00 at second single dose (pending to clarify), for COVID-19 immunisation. Medical history included COVID-19, high blood pressure (BP) and high cholesterol and myocarditis. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. 24 hours after receiving the first vaccine (23Dec2020 16:00), the patient experienced chills fever body aches and fatigue. The events were non-serious. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the events. Outcome of the events was recovered in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure high; COVID-19; High cholesterol; Myocarditis,,,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,OT 918972,,35.0,F,"Headache; Fatigue; The patient received BNT162B2 and was lactating; The patient received BNT162B2 and was lactating; This is a spontaneous report from a contactable healthcare professional reporting for herself and her baby. This is the maternal report. A 35-year-old female patient (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EH9899) intramuscular, on 16Dec2020 at 10:00, in right arm, for COVID-19 immunisation. No other vaccine was given within 4 weeks before. The patient was breastfeeding. Allergies to medications, food, or other products: no. The patient had no COVID before vaccination. Concomitant medications included ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS), vitamin D and calcium. The patient was lactating and on 17Dec2020 her baby seemed to have had an upset stomach, she had trouble sleeping and spit up a few times which was abnormal for her. On 17Dec2020 the patient experienced headache and fatigue which both resolved with lasting effects on an unspecified date in Dec2020. Treatment included paracetamol (TYLENOL). Since the vaccine she had had a headache daily. The events required physician office visit. COVID was not tested after vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020511585 baby case",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/16/2020,0.0,PVT,PRENATAL VITAMINS [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PYR; VITAMIN D [COLECALCIFEROL];,Breast feeding,,,,"['Fatigue', 'Headache', 'Off label use', 'Product use issue']",1,PFIZER\BIONTECH,OT 918973,ME,33.0,F,nausea and vomited x 1 the morning after receiving the vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,UNK,,,,,,"['Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 918974,MO,,F,"being tested positive; being tested positive; felt very sick; congestion; This is a spontaneous report from a contactable other healthcare professional (patient herself). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient felt very sick and that's not her normal. The patient felt great after getting the vaccine she hadn't felt that in a while. Today (23Dec2020) the patient had this congestion and 4 -5 people came back positive post covid-19 vaccination on unknown date. All of them sent home after being tested positive. The patient just someone to keep track, she just wanted Pfizer to know. She didn't have any problems, she was working COVID patients. They had a lot new cases. She just didn't feel 100%. The patient wanted to know if it's safe for her to get the second dose after being tested COVID positive post vaccination. The outcome of events was unknown.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. The company cannot completely exclude a causal relationship between the reported events and vaccination with BNT162B2. Additional information regarding therapy vaccination date, lot number and investigation results will aid in comprehensive assessment of the case.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/23/2020,,UNK,,,,,,"['Malaise', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 918975,CA,,F,"she reported on 18Dec2020 got vaccine later that day tested positive; she reported on 18Dec2020 got vaccine later that day tested positive; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 18Dec2020 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. She reported on 18Dec2020 got vaccine later that day tested positive with outcome of unknown. She asked can she still receive the 2nd dose of the vaccine or should she repeat the vaccination series. The patient underwent lab tests and procedures which included Sars-Cov-2 test: positive on 18Dec2020. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/18/2020,0.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 918976,IL,,U,"received the (1st dose of) COVID-19 vaccine 5 days ago and tested positive; received the (1st dose of) COVID-19 vaccine 5 days ago and tested positive; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Device Type: Vial), intramuscularly on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the (1st dose of) COVID-19 vaccine 5 days ago and tested positive on 23Dec2020. PharmD asked if it's possible to administer Bamlanivimab to a patient who received the (1st dose of) COVID-19 vaccine 5 days ago and tested positive. Pharmacist mentioned that as Bamlanivimab was an EUA drug, they cannot go outside of the recommendations, and given that no information was available about its use after a dose of the COVID-19 vaccine, it is possible that Bamlanivimab may not be administered. Explained Pfizer MI is unable to provide a direct recommendation, was referred to the patient's Docton for guidance: Before receiving the next dose of the COVID-19 vaccine, and to clarify if Bamlanivimab should be administered. The outcome of events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported tested positive 5 days after COVID-19 vaccine is considered related to the administration of BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/23/2020,5.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH,OT 918977,NY,70.0,M,"PCR test positive for COVID-19 but no signs of COVID-19; PCR test positive for COVID-19 but no signs of COVID-19; This is a spontaneous report from a contactable physician reporting for himself. A 70-year-old male patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration in arm left, on 17Dec2020 at 09:00 AM, at single dose, for Covid-19 immunisation. Medical history included hypertension, high cholesterol, benign prostatic hyperplasia, drug allergy and food allergy all from unknown date and unknown if ongoing. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient received unknown medications within 2 weeks of vaccination. Historical vaccine included typhoid vaccine (unknown trade name) on unknown date and the patient experienced drug allergy. The day after vaccination with bnt162b2, on 18Dec2020 at 04:00 PM, the patient experienced PCR test positive for COVID-19 but no signs of COVID-19. The patient did not receive any treatment as a result of the event. The event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included: COVID-19 PCR test positive (18Dec2020), nasal swab positive (18Dec2020). Outcome of the event was unknown. The information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 PCR test positive and suspected lack of efficacy due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/18/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Benign prostatic hyperplasia; Drug allergy; Food allergy; High cholesterol; Hypertension,,,"['Culture positive', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 918978,NC,36.0,M,"Harder to breathe; Heaviness on Chest; Hot Feeling in back of throat behind nose and down throat; Hot Feeling in back of throat behind nose and down throat; This is a spontaneous report from a contactable health professional, the patient. A 36-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 23Dec2020 at 15:00 (at the age of 36-years-old) as a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported; however, there were no other medications the patient received within 2 weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 23Dec2020 at 15:00, the patient experienced a hot feeling in the back of the throat behind the nose and down the throat and then heaviness on the chest and it was harder to breathe. The patient was treated for the hot feeling in the back of the throat behind the nose and down the throat and then heaviness on the chest and it was harder to breathe with 50 mg of oral diphenhydramine (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the hot feeling in the back of the throat behind the nose and down the throat and then heaviness on the chest and it was harder to breathe were resolved on Dec2020. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chest discomfort', 'Dyspnoea', 'Nasal discomfort', 'Throat irritation']",1,PFIZER\BIONTECH, 918979,CA,,M,"8min after injection, felt dry mouth; BP was checked, SBP was 160s, HR 110s. Felt a little dizzy. Felt some palpitations. BP went down soon thereafter to 140s, but HR still 100s (above baseline).; BP was checked, SBP was 160s, HR 110s. Felt a little dizzy. Felt some palpitations. BP went down soon thereafter to 140s, but HR still 100s (above baseline).; BP was checked, SBP was 160s, HR 110s. Felt a little dizzy. Felt some palpitations. BP went down soon thereafter to 140s, but HR still 100s (above baseline).; BP was checked, SBP was 160s, HR 110s. Felt a little dizzy. Felt some palpitations. BP went down soon thereafter to 140s, but HR still 100s (above baseline).; This is a spontaneous report from a non-contactable Physician (Patient). A 36-year-old male Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 at 12:45 PM at single dose (vaccine location was Left arm) via unknown route of administration for unknown indication. Medical history included Psoriasis and concomitant medications were not reported. There were no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 8min after injection on 18Dec2020, Patient felt dry mouth, BP was checked, SBP was 160s, Heart rate (HR) 110s. He Felt a little dizzy and some palpitations. BP went down soon thereafter to 140s, but HR still 100s (above baseline). Patient received Benadryl 25mg IV as treatment. Patient did have covid prior vaccination and did not have covid tested post vaccination. Patient went to Emergency Room Visit. The outcome of the events was recovered on 18Dec2020. No follow-up attempts are possible. Information about lot/batch number could not be requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Psoriasis,,,"['Blood pressure increased', 'Blood pressure measurement', 'Dizziness', 'Dry mouth', 'Heart rate', 'Heart rate increased', 'Palpitations']",1,PFIZER\BIONTECH, 918980,AL,39.0,M,"guillain barre syndrome; stroke; left thigh burning; Left b/l gluteal burning/bilateral gluteal burning; paresthesia; mid back burning; right side burning / right thigh burning; b/l hand numbness/bilateral hand numbness; left facial numbness; b/l foot numbness/bilateral foot numbness; This is a spontaneous report from a contactable physician (patient). A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 19Dec2020 at single dose for prevention. Medical history included none. There were no concomitant medications. Caller states, he received the covid vaccine 19Dec2020 and on 25Dec2020 he was experiencing left facial numbness, b/l foot numbness, b/l hand numbness on 26Dec2020, right side burning on 28Dec2020, Today (29Dec2020) he has had left thigh burning, and Left b/l gluteal burning and paresthesia. No motor issues and no tendon issues, all intact. Also had mid back burning on 28Dec2020 that comes and goes. He has heard that there is a described neuropathy with the virus and/or with the vaccine and wants more information on that. Curious if anyone has anything similar? and makes mention of possible Gillian Barre Syndrome. States that he has had a potential reaction. He had his dose on 19Dec2020. On 25Dec2020 he developed left facial numbness, then later that day he developed bilateral foot numbness. On 26Dec2020, he developed bilateral hand numbness, on 28Dec2020 he developed right thigh burning, and today (29Dec2020) he has developed left thigh burning, and bilateral gluteal burning and paresthesia. States that he has been kind of freaking out about it. He doesn't have any motor issues. States that he heard that there is a described neuropathy with the virus, but not with the vaccine, is that true? The left facial numbness resolved on either 26Dec2020 or 27Dec2020. States that the symptoms were concerning because it could have been a stroke. States his symptoms were moderate. States that due to the bilateral foot and hand numbness, he had a LP, brain and spine MRI, and blood work done on 26Dec2020. All came back completely normal. When asked about causality, caller states that it makes the most sense for his symptoms to be caused by the vaccine due to his age and the fact that all his testing was completely normal. Reporter seriousness for left facial numbness, bilateral foot numbness, bilateral hand numbness, right thigh burning, left thigh burning and bilateral gluteal burning and paresthesia: Medically significant. The outcome of the event left facial numbness was recovered in Dec2020. The outcome of the events guillain barre syndrome, stroke and mid back burning was unknown. The outcome of the other events was not recovered.; Sender's Comments: Based on the temporal relationship the association between the reported serious adverse events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/25/2020,6.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Anxiety', 'Blood test normal', 'Burning sensation', 'Hypoaesthesia', 'Lumbar puncture normal', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging spinal normal', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 918981,,28.0,F,"Vaccine exposure during pregnancy; Partial placenta previa; This observational study case, received on 30-Oct-2020 from other health professional and concerned a 28-year-old, female, pregnant subject of body weight: 133 lbs, height: 63.3 inches and body mass index (BMI): 23.3, enrolled in a prospective observational safety study. The subject's concurrent conditions included anxiety, acid reflux and morning sickness. The subject's past medications included Bonjesta (doxylamine succinate, pyridoxine hydrochloride) for morning sickness, nexium and famotidine both for acid reflux. The subject's concomitant medications included Dexilant (dexlansoprazole), cimetidine and sucralfate for acid reflux, citalopram from anxiety, Phenergan (promethazine) and Zofran (ondansetron) for morning sickness and prenatal plus DHA (vitamins nos, docosahexaenoic acid) for pregnancy. The subject's obstetrical history included one previous pregnancy with one full term live birth. The subject had no history of offspring with major congenital malformation (MCM). The subject had no maternal or paternal medical history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period (LMP) date was 24-Jun-2020. The subject's estimated delivery date (EDD) was reported as 31-Mar-2021 and corrected estimated date of delivery (CEDD) was reported as 01-Apr-2021. The type of pregnancy was singleton. On 25-Aug-2020, the ultrasound revealed no MCM. On 02-Sep-2020, the counsyl chromosome 13, 18, 21 plus sex chromosome analysis and ultrasound revealed no MCM. On 12-Oct-2020, at approximately 15 weeks of gestation (calculated per LMP), the subject was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV) (influenza vaccine; dose, route of administration and anatomical location: not reported) (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation. The batch number reported was P100253284. On the same day, the maternal serum alpha fetoprotein screening (MSAFP/Serum marker) revealed borderline elevation for spina bifida and it was unknown if MCM was noted. On 20-Oct-2020, the MSAFP/Serum marker - repeat revealed no MCM. On 03-Nov-2020, the ultrasound revealed partial placenta praevia and fluid collection near left kidney related to baby. On 01-Dec-2020, the ultrasound revealed MCM: lymphangioma of foetus. The outcome of the event 'placenta praevia' was not reported. The reporter did not provide a causality assessment. The event of 'placenta praevia' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department. This case is linked with case 202008416, due to the corresponding baby case. Additional information received from other health professional on 21-Dec-2020 with additional document received on 29-Dec-2020: Two additional lab tests added. Placenta praevia added as event and case was upgraded from non-serious to serious. Fluid collection near left kidney related to baby and lymphangioma noted as baby case opened. The narrative was amended accordingly. Company comment: A 28-year-old, female, pregnant subject experienced placenta praevia approximately 28 days after administration of Afluria QIV. The subject's concurrent conditions included anxiety, acid reflux and morning sickness. Concomitant medications included Dexilant (dexlansoprazole), cimetidine and sucralfate for acid reflux, citalopram from anxiety, Phenergan (promethazine) and Zofran (ondansetron) for morning sickness and prenatal plus DHA (vitamins nos, docosahexaenoic acid) for pregnancy. Causality is assessed as not related due to chronological implausibility. Vaccine exposure during pregnancy is assessed as unrelated per company conventions.; Sender's Comments: Company comment: A 28-year-old, female, pregnant subject experienced placenta praevia approximately 28 days after administration of Afluria QIV. The subject's concurrent conditions included anxiety, acid reflux and morning sickness. Concomitant medications included Dexilant (dexlansoprazole), cimetidine and sucralfate for acid reflux, citalopram from anxiety, Phenergan (promethazine) and Zofran (ondansetron) for morning sickness and prenatal plus DHA (vitamins nos, docosahexaenoic acid) for pregnancy. Causality is assessed as not related due to chronological implausibility. Vaccine exposure during pregnancy is assessed as unrelated per company conventions.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,10/12/2020,10/12/2020,0.0,OTH,DEXILANT; CIMETIDINE; CITALOPRAM; PHENERGAN [PROMETHAZINE]; ZOFRAN [ONDANSETRON]; SUCRALFATE,Acid reflux (oesophageal); Anxiety; Morning sickness,Medical History/Concurrent Conditions: Live birth; Primigravida,,,"['Alpha 1 foetoprotein abnormal', 'Exposure during pregnancy', 'Foetal disorder', 'Placenta praevia', 'Ultrasound antenatal screen abnormal']",UNK,UNKNOWN MANUFACTURER,OT 918982,GA,37.0,F,"Left arm large golf ball size knot, tender, red, itchy, stiffness in arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,WRK,nuva ring,none,none,,sulfa,"['Erythema', 'Musculoskeletal stiffness', 'Nodule', 'Pruritus', 'Tenderness']",1,MODERNA,IM 918985,CA,49.0,M,Approximately 4 days after vaccine I started experiencing sharp lower back and left hip pain. Also my left foot feels like pins and needles.,Not Reported,,Not Reported,Not Reported,,Yes,N,12/16/2020,12/19/2020,3.0,OTH,"Metformin, Valsartan, Adderall, Asprin, Testosterone Enanthate, Anastrozole.",Had skin infection and took antibiotics 2 weeks prior,"Left Hip replacement 2014, Borderline diabetic, Pituitary adenoma",,None,"['Arthralgia', 'Back pain', 'Inflammation', 'Paraesthesia', 'X-ray']",1,PFIZER\BIONTECH,IM 918986,IA,52.0,F,"Arm pain, extreme fatigue, muscle spasm (charley horse) in left inner thigh, shin and foot.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,"citalopram, lorazepam, amitriptyline, cyclobenzaprine, B12 monthly injection",non-alcoholic fatty liver disease diagnosed 12/2020 hypothyroidism diagnosed 12/2020,osteoarthritis gastric bypass post 15 years,,allergies to penicillin and levofloxacin,"['Fatigue', 'Muscle spasms', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 918987,AZ,35.0,F,"Left sided facial weakness, numbness and tingling in face, cheek, tongue, jaw, and neck. Diagnosed with Bells Palsy on 01/04/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,OTH,Colace 300mg daily,None,None,Rash following flu in 2016,None,"['Facial paralysis', 'Facial paresis', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 918988,TX,32.0,F,"Severe Allergic reaction which required intervention from the hospital. I received 125 mg of Solumedrol IV, 65 mg of Benadryl IV, 50 mg of Hydroxizine IM, and 20 mg of Famotidine to stop the severe allergic reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,Zyrtec 20 mg 2x daily; Claritin 20 mg daily; Advair inhaler 2x daily; Xyzal 20 mg daily,none,Asthma and severe Allergies,,"Peanuts, Beans, Cesar Salad Dressing, & Avocado",['Hypersensitivity'],UNK,MODERNA, 918989,MA,29.0,F,"Significant tenderness at site of the injection for 3 days, pain when moving arm, underarm swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,WRK,Junel FE birth control,no,no,"Sore arm from seasonal flu vaccine, similar to this response",no,"['Injection site pain', 'Oedema peripheral', 'Pain']",1,MODERNA,IM 918990,NY,37.0,F,"Received Moderna vaccine at 9:00 am today and while waiting in the monitoring room, complained of feeling her heart was racing, was put on stretcher, vitals were monitored, BP noted to be 160/ 100 initially and for next 25 mins monitoring came down to to 140 -150/ 95, did not complain of shortness of breath, no rash or pruritus noted, ambulance transport was requested and husband was with patient, was transported to ED, and discussed with ED attending Dr. Followed up with pt in ED subsequently , did not have any additional symptoms and initial symptoms nearly resolved and discharged from ED subsequently at 12:30. This does not seem to be an anaphylaxis reaction, nonetheless VAERS reporting is being filed, has set her up to discuss with allergy and immunology group here.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,None,No,None,,NKA,"['Blood pressure increased', 'Palpitations']",1,MODERNA,IM 918991,NY,90.0,M,"Fever(101.8), muscle pain, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,SEN,,,,,,"['Full blood count', 'Malaise', 'Microbiology test', 'Myalgia', 'Pyrexia', 'Urine analysis']",UNK,PFIZER\BIONTECH,IM 918992,TX,39.0,F,Headache sweats body chills fever trouble breathing,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,SEN,Super B complex Vitamin D Claritan D,,Asthma,,Midrin-hives,"['Chills', 'Dyspnoea', 'Headache', 'Hyperhidrosis', 'Pyrexia']",1,PFIZER\BIONTECH,IM 918993,ND,25.0,F,Redness began in my left arm 9 days after the injection. The redness is not painful and does not bother me but it is warm to the touch. It is still red and warm as of 1/4/21.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/01/2021,9.0,OTH,Sprintec (Birth Control),None,None,,None,"['Erythema', 'Skin warm']",1,MODERNA,SYR 918994,CA,34.0,F,"Patient received Pfizer COVID vaccine 0.3 mL IM x1 on 1/4/2021 @0808. Patient had NKDA and was observed for 15 minutes after administration with no adverse reactions observed. Patient returned to work and noticed swelling in left arm around 0900. Patient returned to clinic complaining of left sided arm tingling and feeling hot. Also edema to ear lobe and arm. Patient given Benadryl 50 mg po x 1 liquid @0916. No sign of respiratory distress, blood pressure 134/84, and no other signs of advancing allergic reaction.. Patient discharged to husband @1021.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,,,,,NKDA,"['Feeling hot', 'Oedema', 'Oedema peripheral', 'Paraesthesia', 'Peripheral swelling']",1,PFIZER\BIONTECH,IM 918995,MI,65.0,F,"Uneasiness, tightness in throat, nausea. Administered Epi Pen",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,PVT,estradiol symbicort albuterol fenofibratProventil,None Known,Diabetes Hypertension Hashimoto's disease Asthma Meniere's disease Seasonal allergiex,,Aspirin Atenolol Cefdinir Codeine dextrose Erythromycin estradiol Gemfibrazil IV dye Levofloxacin Macrolides Meperidine Metronidazole Nitrofurantoin PCN Propoxyphene N-apap,"['Anxiety', 'Nausea', 'Throat tightness']",1,MODERNA,IM 918997,VT,26.0,F,"after injection on 12/23 had red, raised, warm area lasting 3 days. On friday 1/1/2021 noticed that area came back, warm , red, raised and tender to touch. This lasted until Sunday 1/3/2021. On monday 1/4/21 the is a small amount of redness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,PVT,,,,,,"['Erythema', 'Pain of skin', 'Skin warm', 'Swelling']",1,MODERNA,IM 918998,ME,66.0,F,"Patient developed painful hives, blisters, burning, itching",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/27/2020,5.0,WRK,"levothyroxine, hydroxychloroquine, losartan/hctz, duloxetine",,,,"lactose, levaquin","['Blister', 'Burning sensation', 'Pain', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH, 919000,OH,49.0,F,"I had itching and redness and knots that formed in my left leg. The knots were at the site of a vericose vein. I sought tx at an ER on 12/26 to ensure it was not a blod clot. I followed up with my family dr on 1/4/2021 (When her office reopend) and was diagnosed with Superficial Thrombophlebitis. The knots remain in my leg. The redness has mostly gone away. My PCP felt as I recenlty had covid, the vaccine likely flared up the inflamation in my body and caused this condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,WRK,Jelessa (birth control) Clarinex (alergy meds) Amlodepine,COVID postive with test on 12/2/2020. First symptoms on 11/30/2020,,,"Penicillin, amoxicillin, tetracycline, omnicef, cipro, avelox Bees","['Blood test', 'Erythema', 'Inflammation', 'Nodule', 'Pruritus', 'Thrombophlebitis superficial']",1,PFIZER\BIONTECH,SYR 919001,WI,71.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919002,,29.0,F,"Experienced nausea and dizziness. Lost consciousness in elevator. Blood pressure and heart rate dropped. Husband was present and took me to the ED, where I regained consciousness gradually. Received treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/23/2020,0.0,WRK,,,,,,"['Blood pressure decreased', 'Dizziness', 'Heart rate decreased', 'Loss of consciousness', 'Nausea']",1,PFIZER\BIONTECH,IM 919003,,57.0,F,"10 minutes after injection, patient reported numbness of bottom of the feet, hands, and is experiencing hot/cold episodes, shaking, and pallor of lips. She also reported intermittent nausea. No changes in mental status. Patient was transferred to the ER. In the ER, she denied shortness of breath, facial swelling, hives, vomiting or diarrhea. No chest pain or voice changes. Her EKG was unremarkable. Her symptoms resolved with time, and was discharged on prednisone 20 mg PO for 4 days",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,,,,,Mango,"['Electrocardiogram normal', 'Feeling of body temperature change', 'Hypoaesthesia', 'Nausea', 'Pallor', 'Tremor']",1,PFIZER\BIONTECH,IM 919004,NY,86.0,F,Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,SEN,,,,,,['Pyrexia'],UNK,PFIZER\BIONTECH,IM 919005,NY,56.0,F,"Itching, redness, swelling at site. 12 hours later whole arm was red itchy and hot. Took about 5Benadryl all day long. Lasted about 18 hours .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/01/2021,8.0,WRK,"Bystolic, Losartan, Celexa, Buspirone.",no,"High blood pressure, anxiety, depression.",,Cephalexin,"['Erythema', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Pruritus', 'Skin warm']",1,MODERNA,SYR 919006,MD,46.0,F,"Developed headache and became extremelt tired. Site of injection became red and well as a red spot below the injection site. The following day had severe body aches and joint pain, headache and felt feverish/flush. The redness on my left arm expanded. By Sunday (Day 4) the redness was a large area together, hot to touch and had distinctive red ring outline. Contacted doctor on Monday and scheduked video appointment to evaluate for possible cellulitis and for further instruction on treatment. Appointment at 4:15pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,"Glycopyrrolate, Zoloft and Neurontin",No,Migraines,,None,"['Arthralgia', 'Fatigue', 'Flushing', 'Headache', 'Injection site erythema', 'Injection site warmth', 'Pain', 'Pyrexia']",1,MODERNA,IM 919007,MD,49.0,M,Around 6pm I felt fatigued and tired. I went to bed around 8pm. I could not sleep. Had injection site pain on right arm. Tossed and turned. Had a headache. Became fevered and chilled. Had temperature of 100.1 at 2am on 1/4/2021. Temperature decrease back to 98.3 in the morning hours. Remained fatigue and chilled throughout rest of the day. Minor headache.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,PVT,Truvada 200/300 ; Vyybrid 20 mg; fish oil; multi vitamim,None,Depression; anxiety,,Codeine,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pyrexia', 'Sleep disorder']",1,MODERNA,SYR 919008,IN,45.0,F,"Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headache is not uncommon for me but the extreme drowsiness is). I slept solid through the night (unusual) and the puppy woke me around 5am. (ususal) I felt that i had a heavy? head. My thoughts seemed clear but my head had a fullness to it. Its difficult to describe. I was not stuffy. I had trouble staying awake, to the point I was nodding off at times I should have been able to stay awake. I did not feel safe to work and felt obligated to call in. I slept solidly for the next 5 hours. Later in the day, my affected arm began to have pain radiate from the injection site to my wrist. (probably not unusual). 600mg of Ibuprofen did not seem to help much. By the time I went to bed last night (24+ hrs after receiving the vaccine) I noticed my axillary nymph nodes were extremely tender to the touch and remain so this morning. The pain in my arm still continues to radiate to my wrist but not as intense.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Arthralgia', 'Head discomfort', 'Headache', 'Impaired work ability', 'Injection site pain', 'Lymph node pain', 'Pain', 'Pain in extremity', 'Somnolence']",1,PFIZER\BIONTECH,IM 919009,CT,26.0,F,When I received my vaccination some of the vaccine leaked upon the HCP removing the needle. I did not thinking anything of it and was reassured I had received the whole dose. One week after receiving vaccine my L arm noted to be very itchy. Upon looking at my arm I noticed a lemon sized red raised hive where I received the vaccine. My arm is still mildly sore and the hive has continued since noticing it. I had not noticed it previous to this.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/03/2021,7.0,PVT,Spironolactone 100 mg a day,None,None,,None,"['Erythema', 'Pain in extremity', 'Pruritus', 'Skin swelling', 'Syringe issue', 'Underdose', 'Urticaria']",1,MODERNA,IM 919010,WV,28.0,F,Patient is Dizzy Light Head 5 minutes after administered vaccine. Patient was given a cool compress raised legs and rested. Also Cold wet paper towel was place on back of neck. Patient also requested and was given ammonia inhalant to smell. Patients friend called us back at 2:10pm saying patient is still Dizzy & not feeling right. We instructed patient friend to call ems.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PHM,?,,,,None,['Dizziness'],1,MODERNA,IM 919011,TX,42.0,F,"began to feel foggy/slow, arm too paintful to move within two hours and by 11:20 my tongue I had finally noticed was swollen. EMS was called and I was sent to the ER.I was given benedryll by ems, at ER I was given a steroid, Claritin and another medication for the reaction. Discharged with epi pens, a round of steroids, benedryl initially which was changed to Claritin by follow up dr.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,OTH,Wellbutrin Topamax,none,"asthma, obesity",,"sulfa, penicillin, Geodon, Lamictal","['Bradyphrenia', 'Feeling abnormal', 'Pain', 'Pain in extremity', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 919012,WI,45.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919014,NY,29.0,F,"About 12 hours post vaccination, I developed body aches and fever and chills which persisted for another 48 hours. I had taken Tylenol 1000mg q6 hours about 14 hours after the vaccine for until Saturday. 72 hours post vaccine, body aches and chills are gone, only intermittent headaches that come and go. As of 1/3, 4th day post vaccination I have a red bump under the injection site, it is not raised but it is red and warm to touch and it still hurts while moving my left arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,none,none,none,,none,"['Chills', 'Headache', 'Injection site erythema', 'Injection site mass', 'Injection site warmth', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 919015,PA,37.0,F,"Febrile to 39.4 was unable to work s/t work exclusion algorithm for one shift. Myalgias consistent with fever, relived by 600mg Motrin and sleep.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,None.,None,None,,Nka,"['Impaired work ability', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 919016,NY,60.0,F,12/24- Had tingling in fingers on both hands and red non-raised skin rash on the right side of neck about two inches long; 12/26- 12/27: Had cold chills but no fever and muscle aches; 12/28 - 12/29: Developed sinus symptoms (runny nose and sneezing); 12/30: continued tiredness and aching; Took Claritin 12/28 for possible allergy symptoms with no relief,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/24/2020,0.0,PVT,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Paraesthesia', 'Rash', 'Rash erythematous', 'Rhinorrhoea', 'Sneezing']",UNK,MODERNA,IM 919017,FL,39.0,F,"Raised red rash on trunk and neck. No itching. Started 1.5 days after first dose, resolved 4 days after dose administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,none,none,none,,none,"['Rash', 'Rash erythematous', 'Rash papular']",1,MODERNA,IM 919018,NY,96.0,F,"Low grade fever, Diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,SEN,,,,,,"['Diarrhoea', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 919020,AZ,28.0,M,I experienced vertigo and naseua,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,UNK,,,,,,"['Nausea', 'Vertigo']",UNK,PFIZER\BIONTECH, 919021,IL,62.0,F,Severe joint and muscle pain of entire body 9 days after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/27/2020,9.0,PVT,none,none,none,,yes-latex,"['Arthralgia', 'Myalgia']",1,PFIZER\BIONTECH,IM 919022,MD,28.0,M,Complete loss of vision in the left eye 12 hours after receiving second dose (Moderna mRNA-1273) while having a fever of 102 F for 6 hours. Loss of vision lasted for 1 minute. Loss of vision occurred while standing. Referral to primary care and ophthalmology specialist found normal eye exam and MRI of orbits but presence of tachycardia especially while standing (fluctuations between 60 beats at rest/laying down to 130 beats per minute standing). Postural tachycardia syndrome (POTS) is suspected. Currently pursuing cardiac workup with cardiologist and Covid POTS specialist. POTS specialist believes autoantibody development after vaccination could be suspected as recovering covid patients similarly present to clinic with POTS like symptoms.,Not Reported,,Not Reported,Not Reported,,Yes,N,09/02/2020,09/02/2020,0.0,PVT,"Dutastride 0.5 mg/day, Wellbutrin XL 300 mg/day, Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg)/day.",,,,doxycycline-gastrointestinal.,"['Autoantibody positive', 'Blindness unilateral', 'Computerised tomogram coronary artery', 'Echocardiogram', 'Electrocardiogram', 'Electrocardiogram ambulatory', 'Magnetic resonance imaging brain', 'Ophthalmological examination', 'Postural orthostatic tachycardia syndrome', 'Pyrexia', 'Tachycardia']",2,MODERNA,IM 919023,IA,28.0,F,"She received her vaccine on 12/26/2020. She did not have any initial symptoms to the vaccine. On 1/3/2020 she noticed a small ""bug bite"" size redness at her injection site that had mild pruritus. This morning the area is more the size of a ""sand dollar"" It is warm to the touch, but she does not have any other symptoms, denies any fever. Her past medical history includes asthma and anxiety. She is only on Prozac and PNV (she is not currently pregnant). Encouraged to use ICE, NSAIDS, and 2nd generation antihistamine to manage symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,01/03/2021,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 919024,WA,30.0,M,"Severe arm pain, slightly feverish, various body aches with various intensities, extreme exhaustion",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,WRK,,,,,,"['Fatigue', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 919025,CA,,F,"Patient received the covid vaccine on 12/21/2020. c/o new onset of ""itchy throat"" and dry cough today, 1/4/2021. Denies Fever, HA, fatigue, any ocular or GI symptoms. Last Covid test on 12/30/2020 was negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,01/04/2021,14.0,UNK,,,,,,"['Cough', 'SARS-CoV-2 test negative', 'Throat irritation']",UNK,PFIZER\BIONTECH, 919026,,52.0,M,extreme fatigue that lasted 48 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,UNK,,,,,,['Fatigue'],1,PFIZER\BIONTECH,IM 919027,OH,40.0,F,"Severe nausea and vomiting for 24 hours, extreme headache, lethargy and fatigue for 4 days, muscle and joint pain for 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,None,,,NKA,"['Arthralgia', 'Fatigue', 'Headache', 'Lethargy', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 919028,NE,47.0,F,"After the injection for 3-4 days had firm area under skin at site. Sore arm at site. Then improved. 1 week after injection the arm at site started itching more and more, had firm half dollar size area under skin, site red.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,WRK,Lisinopril HCTZ Lexapro Vitamin D,none,Obesity HTN,,Sulfa,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,IM 919029,WI,50.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,Neosporin,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919030,PA,49.0,M,"8:00 AM received second vaccine shot at the Hospital 8:30 checked in with nurse - felt fine - went home 4:00 PM began to notice some injection site pain 6:00 PM some slight lethargy, aches and malaise 10:00 PM above symptoms worsen 12:00 midnight full on aches, pains, chills, shivering, and nausea. Took advil + tylenol and felt better within 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,Fluticasone Famotidine Sertraline Atorvastatin Amlodipine Clopidogrel Valacyclovir,none,Hi cholesterol Hi BP,,Allergic to penicillin,"['Chills', 'Injection site pain', 'Lethargy', 'Malaise', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 919031,ME,42.0,F,Flushing occurred about from 5-40 minutes after receiving vaccine Nausea began about 20 minutes after receiving vaccine and persisted intermittently for 48 hours afterwards Headache began about 20 minutes after receiving vaccine and persisted intermittently for 12 hours afterwards Muscle pain/aching in neck began about 40 minutes after receiving vaccine and persisted for about 12 hours afterwards Sore right deltoid (injection site) started about 6 hours after vaccine given and persisted for about 60 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,Fexofenadine hydrochloride 180 mg once daily Multivitamin 1 tablet once daily Elderberry elixir 1 teaspoon,None,Migraine,,"seasonal allergies, hayfever","['Flushing', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Neck pain']",1,MODERNA,IM 919032,MO,62.0,F,"Felt a flush of heat, and then HR elevated for a few minutes, making it hard to catch my breath for a brief amount of time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,PVT,,,,,"Carmine, Fragrance, Ylang Ylang Oil, Iodopropynyl Butyl Carbamate.","['Dyspnoea', 'Heart rate increased', 'Hot flush']",1,MODERNA,IM 919033,NY,56.0,F,"Morbilliform rash started am of 1/2/2021 on abdomen and then lower chest to back over 3 days Mild and improving in some areas as progressed to new areas by 1/4/2021 No fever, sore throat, cough, loss of taste or smell",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/02/2021,9.0,PVT,"Osteo BiFlex, vitamin D,C, zinc, magnesium",,Patellafemoral syndrome,,None known,"['Rash', 'Rash morbilliform', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,IM 919034,MO,51.0,F,Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,PVT,,None,,,None,['Pyrexia'],1,PFIZER\BIONTECH,SYR 919035,AZ,80.0,F,None,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,PUB,,,Hypertension,,,['Unevaluable event'],1,MODERNA,SYR 919036,IN,89.0,M,"Patient with extreme nausea and vomiting that started soon after receiving the Moderna vaccine. Patient with loss of consciousness, diaphoresis and garbled speech during a foley catheter exchange thought to be from dehydration. Patient was admitted to Hospital for observation for 2 days",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,12/28/2020,12/28/2020,0.0,SEN,Unknown,unknown,Unknown,,Sulfa antibiotics,"['Bladder catheter replacement', 'Dehydration', 'Hyperhidrosis', 'Loss of consciousness', 'Nausea', 'Speech disorder', 'Vomiting']",1,MODERNA,IM 919037,IL,53.0,F,"pounding heart and shakiness within an hour; fatigue, neck pain, muscle aches, low grade temp by 16 hours after vaccine. Resolved in 5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,"probiotic, fiber, vitamin C, elderberry, zinc, vitamin D, pepcid",none,seasonal allergies,,none,"['Body temperature abnormal', 'Fatigue', 'Myalgia', 'Neck pain', 'Palpitations', 'Tremor']",1,PFIZER\BIONTECH,IM 919038,OK,31.0,F,Temporary weight gain in abdomen/swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,,,"RA, migraines",Egg based shot when I was around 3 years old made me sick.,,"['Abdominal distension', 'Weight increased']",1,MODERNA,IM 919040,MD,41.0,F,"severe muscle aches, rash all over the back, nausea, vomit, severe migraine, all symptoms for 36 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,"vitamin c, zinc, vitamin d, omega 3",none,none,,none,"['Migraine', 'Myalgia', 'Nausea', 'Rash', 'Vomiting']",1,MODERNA,IM 919042,NE,32.0,F,"The afternoon following her injection, she became extremely fatigued/ had body aches/ and sore, swollen arm at injection site. This lasted 3 days per her report. Redness/swelling and pain is still evident.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PVT,"methotrexate, Synthroid & others (unknown name)",unknown,"hypothyroidism, R/A, depression, asthma",,unknown,"['Fatigue', 'Injection site pain', 'Injection site swelling', 'Pain']",UNK,MODERNA,IM 919043,NY,68.0,F,"Low Grade fever, Diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,SEN,,,,,,"['Diarrhoea', 'Pyrexia']",UNK,PFIZER\BIONTECH,SC 919044,MD,65.0,F,"low fever, chills, aches, foggy head and fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,WRK,"metoprolol, levothyroxine, multi vit and zinc",none,"hypo thyroid, Arvd",flu vaccine,adhesive,"['Chills', 'Fatigue', 'Feeling abnormal', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 919046,WI,42.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,SMX/TMP,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919047,MI,22.0,F,"I received the vaccine yesterday at 5 pm. This morning starting at 8 am I had muscle aches, chills, and a headache. I took my temperature around 1 pm today and had a fever of 100.8. Throughout today, my headache has gotten progressively worse. The pain is sharp at the base of my head and radiates down my spine. I cannot put my chin to my chest without excruciating pain. I have had migraines before and this does not feel the same. This headache is more localized in the back of my head and spine. I also have had COVID19 before at the beginning of July 2020 from which the only symptom I had was a loss of smell which returned 2 weeks after my positive COVID test.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,PVT,Oral contraceptive pill,None,None,,none,"['Chills', 'Headache', 'Myalgia', 'Pain', 'Pyrexia', 'Spinal pain']",1,PFIZER\BIONTECH,IM 919049,WA,52.0,F,Injection site soreness. Began 8 hours after injection. Mostly gone at 48 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,,,,,,['Injection site pain'],1,MODERNA,IM 919050,TX,44.0,F,"12/19 - fever, congestion, headache, cough 12/24 - body aches and night sweats in addition to the above 12/31 - add hypertension 1/04 - still have body aches, headache, cough, fever, hypertension",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/19/2020,3.0,PVT,"Zoloft, Apri, Womens multivitamin, emergenC",None,depression,,Sulfa drugs,"['Cough', 'Headache', 'Hypertension', 'Influenza A virus test negative', 'Influenza B virus test', 'Night sweats', 'Pain', 'Pyrexia', 'Respiratory tract congestion', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 919051,IL,40.0,F,"Sever chills, sweating, headache, fever 101-102.5, arm pain and redness that extended into shoulder and axilla.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Eliquis 5 mg BID, multivitamin, apple cider vinegar","Positive COVID 12/10/2020, symptoms began 12/8/2020","Antiphospolipid syndrome. Previous DVT, PE",,NKDA,"['Arthralgia', 'Axillary pain', 'Chills', 'Erythema', 'Headache', 'Hyperhidrosis', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA,SYR 919052,TN,103.0,F,"rash, itching",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,Amlodipine 2.5/10mg take one po daily Aspirin 81 mg po daily Cyanocobalamin 1000mg IM q month on the 14th Glipizide 5mg po daily Humulin R 100units/ml PRN per sliding scale Omeprazole DR 20mg po qd Polyethylene Glycol 17 gm in 4-8oz liquid,,"Psoriasis, DM II, HTN, GERD, Hyperaldosteronism, HLD",,"PCN, Sulfa, Doxycycline, Keflex, Statins","['Pruritus', 'Rash']",1,MODERNA,IM 919053,VA,58.0,M,"12/18 VACCINATION 12/19 WOKE UP, RINGING IN BOTH EARS. CALLED PCP, CONSULTED ENT ABNORMALITY - L INNER EAR; HIGH DOSE STEROIDS, 10 DAYS, 60 MG/DAY. WEEK 2; TINNITUS GOT WORSE. DR. PRIMARY CARE PHYSICIAN MEDICAL EXAM ON 1/6/2021 INJECTION OF STEROIDS.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/18/2020,12/19/2020,1.0,PVT,,,,,,"['Audiogram abnormal', 'Hypoacusis', 'Inner ear disorder', 'Tinnitus']",1,PFIZER\BIONTECH, 919054,PA,44.0,F,"EXPERIENCED IMMEDIATE CHEST TIGHTNESS, TACHYCARDIA, AND HYPERTENSION. BROUGHT TO ED FOR MONITORING AND SYMPTOMS RESOLVED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,UNKNOWN,UNKNOWN,UNKNOWN,,UNKNOWN,"['Chest discomfort', 'Hypertension', 'Immediate post-injection reaction', 'Tachycardia']",1,PFIZER\BIONTECH,IM 919055,MO,55.0,F,a week after vaccine Thur Jan 1 quarter sized red slightly raised round area developed on Right upper arm . grew for next 3 days to entire upper arm . warm to touch . Went away on it's own Sunday Jan 3 in the late afternoon,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,01/01/2021,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 919056,NY,42.0,F,"Pt with c/o extreme nausea and metal taste in her mouth. Received 1000ml bolus of NS IV (11:13am). Solu-Medrol 125mg IV (11:13am), Zofran 4mg IV (11:13am) and Compazin 10mg IV (15.44pm).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Cymbalta 30mg,none,Nerve Pain,,"Morophine, Azithromycin, Flagyl, Clindamycin, Metronidazole,","['Angiogram cerebral', 'Arteriogram carotid', 'Computerised tomogram', 'Differential white blood cell count', 'Dysgeusia', 'Electrocardiogram', 'Full blood count', 'Laboratory test', 'Nausea', 'Prothrombin level', 'Prothrombin time', 'Troponin T']",1,MODERNA,IM 919057,TX,28.0,M,"Body aches, fever 101 F, chills, diarrhoea, loss of taste and smell, followed by shortness of breath, turned out that I became positive with COVID-19 virus and all my family including my mother who is 70+ and my pregnant wife got infected with active virus.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/25/2020,3.0,PVT,None,None,None,,None,"['Ageusia', 'Angiogram pulmonary abnormal', 'Anosmia', 'COVID-19', 'Chills', 'Diarrhoea', 'Dyspnoea', 'Fibrin D dimer increased', 'Lung opacity', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 919058,WA,54.0,F,tingling around mouth and palpitations Sx resolved spontaneously within 5 minutes of onset,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,Methocarbamol 750 MG tablet meloxicam 15 MG tablet buPROPion HCl ER (XL) 150 MG tablet (24 hour) thyroid (ARMOUR THYROID) 30 MG tablet SUMAtriptan (Imitrex) 50 MG tablet niacin 500 MG tablet Progesterone Micronized (PROGESTERONE PO) ARMOUR,None,Eosinophilic esophagitis Allergic rhinitis Eczema Migraine Depression Hypothyroidism Perimenopause History of colon polyps,,Latex Pollen Extract,"['Palpitations', 'Paraesthesia oral']",1,MODERNA,IM 919059,NY,85.0,F,"Low grade fever, Diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,SEN,,,,,,"['Diarrhoea', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 919060,CA,56.0,M,"HA, flushing, HTN",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,unknown,,high cholesterol,,NKA,"['Flushing', 'Headache', 'Hypertension']",1,PFIZER\BIONTECH,IM 919061,OH,25.0,F,"13 minutes after vaccine received, during the 15 minutes requested post vaccine, stated ""feel whoosy"". face flushed at time of statement. BP and HR elevated at time of incident, returned to normal prior to transfer to ED",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,unknown,covid+ 08/2020,anxiety,,nka,"['Blood glucose normal', 'Feeling abnormal', 'Flushing', 'Heart rate increased', 'Hypertension']",1,MODERNA,IM 919062,MD,57.0,F,"Moderna COVID-19 Vaccine- Diarrhea, nausea, fever/99.1",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,WRK,"Escitalopram- 20mg, Lisin/HCTZ 20/12.5mg, Perphenazine 16mg, Levocetirizine 5mg, Rosuvastatin 5mg, Nexium 40mg, Lorazepam 1mg, Modafinil 200mg, Farxiga 10mg, Merformin 1000mg, Symbicort inhaler/budesonide 80 mcg/formoterol furnarate dihydra",Diabetes type 2,"Diabetes type 2, asthma, high blood pressure, acid reflux",,none,"['Diarrhoea', 'Nausea', 'Pyrexia']",1,MODERNA,IM 919063,WI,51.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,"tegaderm, adhesive tape, codeine, seasonal","['No adverse event', 'Product storage error']",1,MODERNA,IM 919064,NJ,49.0,F,Hypertensive sweaty dizzy,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Benadryl,None,None,,Eggs tree nuts shellfish,"['Dizziness', 'Hyperhidrosis', 'Hypertension']",1,MODERNA,IM 919065,CA,28.0,F,"AT 10:38, patient reports feeling anxious and tingling sensation at the occipital area / behind her ears. She denied any flushing, dizziness, headaches, cough, sob, numbness sensation around her mouth, chest discomfort",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,Albuterol inhaler prn Zyrtec 10 mg oral daily prn,No,History of Asthma,,NO,"['Anxiety', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 919067,WA,33.0,F,"Approximately 10 minutes after injection patient started to complain of an itchy throat and a metallic taste in her mouth. No acute distress noted. No oral, facial or throat swelling noted. Lungs clear bilaterally and patient moving air without difficulty. Skin warm and dry. Patient speaking clearly and in full sentences. Patient continued to be monitored. � Patient complained of slight chest ""tightness"" and increased mucus production approximately 20 minutes after initial vaccination. Upon exam no acute distress noted. Lungs clear bilaterally. Skin warm and dry. Patient speaking clearly and in full sentences. Patient able to manage oral secretions, no drooling noted. No oral, facial or throat swelling noted. No notable redness or rash observed. EMS called and arrived without incident. � Patient discharged by EMS and was advised by them to go home and take a Benadryl. Discussed EMS recommendation with patient and she verbalized understanding and stated that she would call 911 or go to ER if symptoms change or worsen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,,,,,CLINDAMYCIN LEVAQUIN PENICILLIN,"['Chest discomfort', 'Dysgeusia', 'Rhinorrhoea', 'Throat irritation']",2,PFIZER\BIONTECH,IM 919068,WA,49.0,F,Watery diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/04/2021,5.0,WRK,,,,,,['Diarrhoea'],1,MODERNA,IM 919069,NY,37.0,F,"two hours after vaccine administration, lasting for approximately one hour, experienced feelings of a racing heartbeat, heaviness in chest, elevated temp and lightheadedness, and general not feeling right, then those symptoms began to subside and over approximately the next two days had the general side effects of sore arm and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,UNK,IUD (Intra-Uterine Device - Mirena - Birth Control),None,Obese,,Sulfa,"['Body temperature increased', 'Chest discomfort', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Pain in extremity', 'Palpitations']",1,MODERNA,IM 919070,MO,37.0,F,Called Employee Health and stated she is off work but wanted to report her symptoms. Stated she has a sore arm. 24 hours after receiving the vaccine she developed a headache that became severe. Had vomiting. Now has swelling of lymph nodes on her right side and her face is slightly puffy.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,PVT,,,,,,"['Headache', 'Lymphadenopathy', 'Pain in extremity', 'Swelling face', 'Vomiting']",1,MODERNA,IM 919071,IN,72.0,F,Red 13-14cm warm area to injection site with hematoma noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,SEN,"Norvasc, Colace, Duloxetine, Eliquis, Lasix, Keppra, Synthroid, Metformin, Percocet, Protonix, Senna, Multivitamin, Toprol XL, Trazodone","U07.1 2019-nCoV acute respiratory disease (Primary) G35 Multiple sclerosis E11.21 Type 2 diabetes mellitus with diabetic nephropathy D64.9 Anemia, unspecified L03.116 Cellulitis of left lower limb E03.9 Hypothyroidism, unspecified I73.9 Peripheral vascular disease, unspecified F33.0 Major depressive disorder, recurrent, mild F41.1 Generalized anxiety disorder F44.5 Conversion disorder with seizures or convulsions R60.9 Edema, unspecified I10 Essential (primary) hypertension I48.0 Paroxysmal atrial fibrillation I27.20 Pulmonary hypertension, unspecified I63.40 Cerebral infarction due to embolism of unspecified cerebral artery I27.81 Cor pulmonale (chronic) I44.0 Atrioventricular block, first degree G89.4 Chronic pain syndrome M62.81 Muscle weakness (generalized) R26.81 Unsteadiness on feet R27.8 Other lack of coordination G47.00 Insomnia, unspecified K59.09 Other constipation K21.00 Gastro-esophageal reflux disease with esophagitis, without bleeding","U07.1 2019-nCoV acute respiratory disease (Primary) G35 Multiple sclerosis E11.21 Type 2 diabetes mellitus with diabetic nephropathy D64.9 Anemia, unspecified L03.116 Cellulitis of left lower limb E03.9 Hypothyroidism, unspecified I73.9 Peripheral vascular disease, unspecified F33.0 Major depressive disorder, recurrent, mild F41.1 Generalized anxiety disorder F44.5 Conversion disorder with seizures or convulsions R60.9 Edema, unspecified I10 Essential (primary) hypertension I48.0 Paroxysmal atrial fibrillation I27.20 Pulmonary hypertension, unspecified I63.40 Cerebral infarction due to embolism of unspecified cerebral artery I27.81 Cor pulmonale (chronic) I44.0 Atrioventricular block, first degree G89.4 Chronic pain syndrome M62.81 Muscle weakness (generalized) R26.81 Unsteadiness on feet R27.8 Other lack of coordination G47.00 Insomnia, unspecified K59.09 Other constipation K21.00 Gastro-esophageal reflux disease with esophagitis, without bleeding",,"Gabapentin, Lyrica, Tubersol","['Injection site erythema', 'Injection site haematoma', 'Injection site warmth']",1,MODERNA,IM 919072,GA,53.0,M,"low back discomfort ""over both kidneys"" that is described as soreness. began approximately 1 hour after the vaccine was administered. denies radiation of pain, dysuria, n/v, fever. pain intermittent for about a wee, increased to constant soreness and increased intensity on 12/31/2020. referred to urgent care",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,OTH,150 mg Trazodone Daily multi-vitamin Melatonin supplement,none,sleep apnea,,none known,"['Back pain', 'Chest X-ray normal', 'Laboratory test', 'Renal function test normal', 'Urine analysis normal']",1,PFIZER\BIONTECH,IM 919073,NJ,63.0,F,Child within 12 hours followed by copious sweating and nausea along with general malaise and pain at injection site. Two days later sharp armpit pain began with tenderness when palpated. Pain worse upon awakening. Four days later large rash at injection site ( left deltoid?) which is hot to touch and swollen. Outlined borders this morning and rash has touched borders but not much more. Alternates being painful and itchy.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,None,None,None,,None known,"['Axillary pain', 'Chills', 'Hyperhidrosis', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Malaise', 'Nausea', 'Tenderness']",UNK,MODERNA, 919074,VA,40.0,F,"Extreme swelling and erythema at vaccination site, mild pain, multiple episodes of diarrhea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,MIL,"Aderall, Welbutrin, Vitamins",None,None,,Morphine,"['Diarrhoea', 'Pain', 'Vaccination site erythema', 'Vaccination site swelling']",1,PFIZER\BIONTECH,IM 919075,FL,19.0,F,"Patient was feeling some numbness in her arm, dizziness and heart rate increased.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,SEN,Unknown,Unknown,,,Unknown,"['Dizziness', 'Heart rate increased', 'Hypoaesthesia']",1,PFIZER\BIONTECH,IM 919076,IN,36.0,F,"12/24/2020 swollen right side lymph nodes under arm; felt ""on fire"" reduced burning sensation over time. Then 1/1/2021 patient got weakness in bilateral arms, felt ""rubbery"" ; left arm and neck lymph nodes swollen 1/3/2021 was seen in ER for full body numbness, prickly heat, like waves of it. Bilateral arm weakness; nerves feel ""on fire"". vomiting x 1 50 mg of Benadryl taken approximately 9 pm on 1/3/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/24/2020,2.0,PVT,Mirena Multi-vitamin Vitamin C Vitamin D,,,"TDAP, seizures, very young",Pertussis part of TDAP,"['Burning sensation', 'Chest X-ray', 'Hypoaesthesia', 'Laboratory test normal', 'Lymphadenopathy', 'Miliaria', 'Muscular weakness', 'Nausea', 'Neuralgia', 'SARS-CoV-2 test', 'SARS-CoV-2 test negative', 'Vomiting', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 919078,MO,37.0,F,Hives / red rash on both legs.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,12/24/2020,0.0,PVT,,,,,"Mild shellfish allergy - causes hives only, no anaphylaxis","['Rash', 'Rash erythematous', 'Urticaria']",1,MODERNA,IM 919079,AZ,62.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PVT,"Lostaren, low dose asprin, not sure on the others",,Diabetic,,"cipro, oxycodone, linsopril",['Unevaluable event'],UNK,PFIZER\BIONTECH, 919080,CA,56.0,M,"flushing, HTN, HA",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,unknown,Unknown,HLD,,NKA,"['Flushing', 'Headache', 'Hypertension']",1,PFIZER\BIONTECH,IM 919081,IL,34.0,F,"SOB, chest tightness, HA, extreme fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,PVT,Pristiq 50 mg,unknown,unknown,,NKDA,"['Chest discomfort', 'Dyspnoea', 'Fatigue', 'Headache', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 919084,IL,24.0,M,"warmth with no fever, fatigue, weakness (generalized), lasting 2 days, missed work 1 day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,WRK,none,none,none,,aloe,"['Asthenia', 'Fatigue', 'Feeling hot', 'Impaired work ability']",1,PFIZER\BIONTECH,IM 919085,MO,62.0,F,"No reaction until today, 12/31/2020 - Injection site is red, swollen and itchy I went to EH and advised to use a compress and monitor.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/31/2020,9.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 919086,WA,33.0,F,"Approximately 10 minutes after injection patient started to complain of an itchy throat and a metallic taste in her mouth. No acute distress noted. No oral, facial or throat swelling noted. Lungs clear bilaterally and patient moving air without difficulty. Skin warm and dry. Patient speaking clearly and in full sentences. Patient continued to be monitored. � Patient complained of slight chest ""tightness"" and increased mucus production approximately 20 minutes after initial vaccination. Upon exam no acute distress noted. Lungs clear bilaterally. Skin warm and dry. Patient speaking clearly and in full sentences. Patient able to manage oral secretions, no drooling noted. No oral, facial or throat swelling noted. No notable redness or rash observed. EMS called and arrived without incident. � Patient discharged by EMS and was advised by them to go home and take a benadryl. Discussed EMS recommendation with patient and she verbalized understanding and stated that she would call 911 or go to ER if symptoms change or worsen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,,,,,CLINDAMYCIN LEVAQUIN PENICILLIN,"['Chest discomfort', 'Dysgeusia', 'General physical condition normal', 'Rhinorrhoea', 'Throat irritation']",2,PFIZER\BIONTECH,IM 919087,CA,50.0,M,Acute Pericarditis. Patient was admitted from 12/27-12/28/2020 at hospital by cardiology team who strongly felt the acute pericarditis was due to the Pfizer Vaccine (Dr. was senior cardiologist).,Not Reported,,Yes,Yes,1.0,Not Reported,Y,12/23/2020,12/27/2020,4.0,OTH,Aspirin daily,No illness one month prior to or at time of vaccination,None,,NKDA,"['Antinuclear antibody negative', 'C-reactive protein increased', 'Fibrin D dimer increased', 'Hepatitis C antibody negative', 'Pericarditis', 'Red blood cell sedimentation rate normal', 'Troponin T increased']",1,PFIZER\BIONTECH,IM 919088,OR,46.0,F,"patient (staff member) received their vaccine at approximately 0817, they returned to the clinic at 1000 stating they were starting to feel tingling in their fingertips, metallic taste in the mouth, and trouble breathing. Vitals were taken and found to be within normal limits as described by patient. At 1002, 50mg PO Diphenhydramine was given orange juice. Patient asked if they could lay down to see if that would help her to catch her breath. She went to the bed and practiced her breathing exercises while waiting for the ambulance to come and take her to the emergency room. Ambulance arrived and care was transferred.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,none specified by client,None identified,none stated,,NKDA,"['Dysgeusia', 'Dyspnoea', 'Paraesthesia']",1,MODERNA,IM 919089,AK,58.0,M,Main symptom: Shortness of Breath Treatment: Diagnostic tests and IV fluids-No breathing treatments Outcome: Felt better,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/03/2021,11.0,PVT,"Metformin 1000 mg BID, Actose 30 mg QD, Jardianz 25 mg QD, Trulicty 1.5 mg sub q once week, On Wednesday, Gabapentin 600 mg BID, Diltiazem 240 mg BID, Lasix 60 mg QD, Spirnolactone 12,5 mg QD, Tylenol 1000 mg bid, magnesium oxide 400 BID, v","Diabetes, PSVT, Factor 5 Leiden deficiency with PE, GERD, venous insuff. , Scalp foliculitis",see above,,"Allergy to Erythromycin and Sulfa (Septra), Compazine No food allergies","['Blood lactic acid decreased', 'Dyspnoea', 'Influenza virus test negative', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 919090,WI,39.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse events noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,"Mucinex, latex","['No adverse event', 'Product storage error']",1,MODERNA,IM 919091,MD,52.0,F,"Nausea, headache, muscle ache, exhaustion, chills, low grade fever, and pain at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,Levothroxine 100mcg Zyrtec 10mg Flonase Wellbutrin 300mg Metoprolol 25mg,,hypothyroidism,,Sulfa Augmentin,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,IM 919092,VA,59.0,F,diarreah since day two after the vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/23/2020,2.0,PVT,zoloft 50 mg/day albuterol/ as needed meloxicam 15 mg/day cyclobenzaprine 5mg/day Activella 1mg-.5 mg/day zyrtec 10 mg/day,Asthma,arthritis,,codiene,['Diarrhoea'],1,PFIZER\BIONTECH,SYR 919093,CA,44.0,F,Extreme vertigo woke up in the middle of night dizzy and teeth chattering. No fever.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,WRK,,,,,,"['Chills', 'Dizziness', 'Vertigo']",1,MODERNA,IM 919094,NM,70.0,M,Patient was experiencing dizziness.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/01/2021,01/03/2021,2.0,PHM,Bystolic 5mg,,Hypertension; Tumor on Kidney,,NKDA,['Dizziness'],1,PFIZER\BIONTECH,IM 919095,OK,52.0,F,"Site on left upper arm has become red, hard and very itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,PVT,"Multivitamin, Fish oil, Vit C, Vit D, Lexapro, Metroprol, Lisinipril, Calcium, progesterone. asprin",NONE,Tachycardia,,NONE,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus']",1,MODERNA,IM 919096,WA,65.0,F,"Nausea, vomiting, headache. Symptoms improved with medication (ondansetron). Headache and mild fatigue continued through 1/4/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,,,,,,"['Fatigue', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 919097,MN,46.0,M,"He stated he was fine for 20 minutes after the administration, but noticed driving home that the left side of his face felt funny/tingly. He says it progressed that evening to numbness and states his spouse noticed slight swelling to his face. He also complained of pain to his teeth and gums. He voiced concerns about bell's palsy, but stated he didn't notice any asymmetry or paralysis in his face and his symptoms have resolved entirely as of today 1/4. He was never seen or evaluated while he was having symptoms, unfortunately, and was able to continue working. Denied chest pain or difficulty breathing, no rash. He reports self-medicating with prednisone on sat/sun with improvement and as mentioned, is now asymptomatic.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,none reported,unknown,none reported,,None known,"['Gingival pain', 'Hypoaesthesia', 'Paraesthesia', 'Swelling face', 'Toothache']",1,PFIZER\BIONTECH,IM 919098,MO,41.0,F,"Mild transient flushing Vital Signs 0900 - BP 124/79, HR 110, RR 22, Temp 98.2, SPO2 98% Vital Signs 0915 - Blood Glucose 78 - crackers given with drink Vital Signs 0935 - Blood glucose 87 10 min post crackers, BP 118/75, HR 80, RR 18, SPO2 100%",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Blood glucose normal', 'Flushing']",1,MODERNA,IM 919100,TX,39.0,F,"started with a migraine then nausea/vomiting, chills, fever, severe swelling of the injection site with redness, fatigue, muscle and joint pain. This lasted for over 24 hours then got better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Metronidazole 1% Topical Gel for my face. Minocycline 100mg twice daily for my face,"I had cold/flu like symptoms, no taste/smell for 1 week. Had covid rapid test and was negative.",none,,Pineapple,"['Arthralgia', 'Chills', 'Fatigue', 'Injection site erythema', 'Injection site swelling', 'Migraine', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 919101,TX,58.0,F,"A rash appeared on my lower left arm and has spread a bit to my upper arm. Each day the rash is more widespread although there is no fever, no itching, no raised bumps. I contacted my doctor who provides care management for lymphedema, and provided pictures of the rash. He agrees it is not a cellulitis infection but can provide no further information and did not ask me to come for an appointment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/07/2020,12/24/2020,17.0,PVT,Zoloft - 150 mg Selenium - 400 mg B12 Bariatric multi vitamin,none,Lymphedema as a result of breast cancer in left arm,,"Penicillin, Vancomycin, sulfa drugs",['Rash'],2,PFIZER\BIONTECH,SYR 919105,WA,28.0,M,"Erythema multiforme-like rash, mid-to-distal extremities, involving hands/feet both aspects. Not involving face/mouth/throat/lungs/eyes (no SJS severity or distribution). Occurred about 2nd or 3rd day after vaccination. Sx persisted 2 days before patient contacted medical by phone. I instructed him to go to ED and he was seen in ED and dxd with ""allergic reaction"" and ""nonspecific skin eruption"" by ED Dr., who Rxd prednisone and hydroxyzine. Rash plateaued and is gradually waning 3rd day s/p ED Tx.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/02/2021,3.0,MIL,None,None,None,,None,"['Erythema multiforme', 'Hypersensitivity', 'Rash']",1,MODERNA,IM 919106,IL,59.0,F,"I received the shot and had the normal chills, body aches, and sore arm then on day 2 i broke out in a rash all over my torso, red raised macules consistent with a drug rash. i had no other symptoms no SOB, no swelling no hives. Took zyrtec and benadryl it was improved the next day and gone the following day. I had a siimiliar incident when i received the shingrix shot on 9/16/2020. i did not repeat that shot. Wondering if I should repeat this one",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,letrozole multi vitamin vit B vit D fish oil probiotic,none,WAs treated for urterine cancer finished CHemo 9/2019 cured,the same rash after a shingrix shot given 9/16/2020 I was 59 years old,NKA,"['Chills', 'Drug eruption', 'Pain', 'Pain in extremity', 'Rash', 'Rash erythematous', 'Rash papular']",1,MODERNA,SYR 919107,WI,21.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919108,NY,100.0,F,"Fever, Malaise",Yes,01/03/2021,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,SEN,,,,,,"['Blood culture', 'Culture urine', 'Full blood count', 'Malaise', 'Pyrexia', 'Urine analysis']",UNK,PFIZER\BIONTECH,IM 919109,ME,30.0,F,"earache, congestion, body aches, nausea, vomiting, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,PVT,"bupropion, escitalopram, lamotrigine, hydroxyzine",None,"Anxiety, GERD, SVT",,Ceclor,"['Ear pain', 'Fatigue', 'Nausea', 'Pain', 'Respiratory tract congestion', 'Vomiting']",1,MODERNA,IM 919110,WI,35.0,F,"After about 10 min after receiving the vaccine, patient reports symptoms of difficulty breathing, wheezing and throat tightness. RN observed audible wheezing and shortness of breath. Was taken immediately to ER via w/c and treated with Epi, Benadryl, Pepcid, and Solu-Medrol. Was able to be DC home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,,,"Hx of anaphylaxis reactions. Multiple allergies with anaphylaxis. Discussed with allergist, recommendation was to receive the vaccine.",,Many allergies,"['Dyspnoea', 'Throat tightness', 'Wheezing']",1,MODERNA,IM 919111,OH,40.0,M,"I received the vaccine 30 min. prior to starting my shift as a Nurse in the ED. About 1 hour after receiving the shot while standing I felt off balance and began to have a vertigo like dizziness. I sat down and tried to drink some water but began spitting the water back up and dry heaving after trying to drink. I did not feel nauseous if I was not drinking. I did feel the sensation of a slight lump in my throat. I did not have any shortness of breath, tachycardia, rash or fever. I did not want to check in as a patient so I called my wife to come and pick me up from work. Before I left I had the pharmacy send me some Pepcid and Benadryl and I took 25mg of Benadryl and 20mg of Pepcid before leaving. I left work around 1400 and now at 1500 I am able to drink fluids. The slight lump in my throat seems to have improved. I still feel a little dizzy and off balance.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,None,None,None,,"PCN, Sulfa","['Balance disorder', 'Dizziness', 'Retching', 'Sensation of foreign body', 'Vertigo', 'Water pollution']",1,MODERNA,IM 919112,NM,42.0,F,"45 minutes following the injection, diziness and near fainting.Within a few hours, severe arm pain, limiting range of motion to about 30%. The day after the injection experienced diarrhea all day, as well as ongoing severe arm pain, limited range of motion to aprox 30%.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,none,none,none,,none,"['Diarrhoea', 'Dizziness', 'Mobility decreased', 'Pain in extremity', 'Presyncope']",1,MODERNA,IM 919113,ID,31.0,F,"15 minutes after vaccine patient had light headedness, body chills and patient said she had a ""rush of blood feeling in her body"". Vital signs remained stable and patient observed x 90 mins.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,,,,,"egg (nausea, stomach cramps)","['Chills', 'Dizziness', 'Sensation of blood flow']",1,PFIZER\BIONTECH,IM 919114,MO,39.0,F,"4x3 inch area at injection site red, swollen, warm. Occurred 1 week after injection. Went to urgent care, diagnosed with cellulitis, antibiotics given.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/29/2020,8.0,PVT,,,,,,"['Injection site cellulitis', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 919115,NV,59.0,F,"Fever 103.8, shaking chills, severe headache, body?s aches, burning eyes, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,UNK,"Lamotrigine,, Pantoprozole, metoprolol, Exemestane, Loratadine, Vit D3, Vit C, Calcium",None,"Multiple Sclerosis, Breast cancer, Arrhythmia, GERD",,"Penicillin, sulfa drugs, Bactrim, Phenytoin, sumatriptan, Walnuts, bell pepper","['Chest X-ray', 'Chills', 'Dizziness', 'Eye irritation', 'Headache', 'Influenza virus test negative', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,MODERNA,IM 919116,NY,49.0,F,"Chills, nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PUB,"Armorthyroid, Zyrtec, Prevacid.",no,Celiac Sprue.,,"Penicillin, Cipro, Sulfur, Amoxicillin, doxycycline, codeine, gluten.","['Chills', 'Nausea']",1,MODERNA,SYR 919117,WI,38.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919118,LA,34.0,F,"COVID-19 Vaccine #1 received on 12/29/20 @11:40am- That afternoon, mild soreness @ injection site. 12/30/21- moderate pain in upper arm and sharp, stabbing pain in axilla (injection site side). Unable to lift arm straight up due to pain. Evening: Myalgia/joint pain, fatigue, nausea, mild headache. Took Tylenol and Phenergan. 12/31/21- Woke up at 4am with pain in axilla-took tylenol. Moderate pain in upper arm and axilla. Unable to palpate axilla due to pain while at work. Evening: axillary lymphadenopathy noted- walnut sized. Severe myalgia/joint pain, fatigue, nausea, headache, malaise. Took Motrin and Phenergan. Woke up in middle of night with pain in arm/axilla and nausea. took tylenol and zofran. 1/1/21- Worst day of symptoms. Moderate-severe pain in upper arm and axilla. Golf ball sized lymphadenopathy in axilla on injection side. Severe weakness, dizziness, fatigue, myalgia, and joint pain. Low grade temp (99.7), tachycardia (HR averaged 110-115), shortness of breath on exertion with associated tachypnea (RR 24-26). No appetite and nausea. Stayed in bed ALL DAY. Alternated Tylenol/ Motrin, Benadryl & Zofran as needed. Only reason I did not go to ED is because I had a pulse oximeter at home was monitoring O2 sats closely. Never de-sat'ed. Had I not had the pulse ox at home, I would've gone to ED. In the evening, had lymphadenopathy in neck also (same side as injection). 1/2/21- Most symptoms have dissipated except axillary lymphadenoapthy- axilla incredibly tender-golf ball sized. Lymph nodes in neck still palpably enlarged. 1/3/21- Lymph nodes in neck normal. Axillary lymphadenopathy remains with same tenderness. 1/4/21 AM- NO change in axillary lymphadenopathy-tenderness same",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PVT,none,none,GERD,,nkda,"['Arthralgia', 'Axillary pain', 'Body temperature increased', 'Decreased appetite', 'Dizziness', 'Dyspnoea exertional', 'Fatigue', 'Headache', 'Injection site pain', 'Lymph node pain', 'Lymphadenopathy', 'Malaise', 'Mobility decreased', 'Myalgia', 'Nausea', 'Pain', 'Tachycardia', 'Tachypnoea']",1,PFIZER\BIONTECH,IM 919119,CT,28.0,F,"Employee had hives the day following vaccine, went to urgent care received prednisone 50 mg with daily taper, hives have continued to spread daily since. No angioedema or airway issues.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,WRK,"taytulla, spironolactone",none,none,Influenza vaccine 2019,"Influenza shot similar reaction hives after flu vaccine late 2019, had flu vaccine late 2020 no reaction",['Urticaria'],1,PFIZER\BIONTECH,IM 919120,IL,57.0,F,"Patient became near syncopal while at work in surgery department. Felt hot, got dizzy, with nausea while standing and noted she could no longer see/focus on monitor in front of her. Sat down, became pale and diaphoretic. Prodromal symptoms lasted 3-4 minutes before feeling better. No LOC. No change in normal daily routines prior to this event. Proceeded to ED and received fluids/meds and discharged home. EKG, labs completed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,PVT,Diphenhydramine 25mg q6hours PRN Elderberry 1 tablet oral daily MVI 1 tablet daily Triamcinolone Acetonide 0.1% topically 4 times daily PRN,Recent history of cataract surgery 2 weeks prior,Only chronic issue is food allergies. Generally healthy.,,"Multiple food allergies including: wheat, tomatoes, gluten, tomatoes, soy, shrimp, strawberries","['Differential white blood cell count', 'Dizziness postural', 'Electrocardiogram', 'Feeling hot', 'Full blood count', 'Hyperhidrosis', 'Metabolic function test', 'Nausea', 'Pallor', 'Presyncope', 'Vision blurred']",1,MODERNA,IM 919121,NJ,52.0,F,Immediately I had a bitter/metal taste at the end of my throat. It last about 5 hours and and ended about 2:30-3:30pm. I had a bitter/metal taste when I ate anything or drank water.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,WRK,Biotin,Migraine headaches,,20 years ago I got really sick when I got the Flu vaccine.,,['Dysgeusia'],1,PFIZER\BIONTECH,SYR 919122,IA,56.0,F,24 hours after injection had same side axilla lymph node swelling and discomfort,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PVT,Estradiol Vitamin D Tylenol,None,None,,None,"['Discomfort', 'Lymphadenopathy']",1,MODERNA,IM 919123,TX,37.0,F,"One week after Moderna vaccine, an ipsilateral tender supraclavicular lymph node developed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,None,None,None,,none,['Lymph node pain'],1,MODERNA,IM 919124,MO,43.0,F,"In the overnight hours between 12/29 and 12/30 the injection site became sore red and swollen again as if it was a fresh shot. It has heat to it and is slightly larger and harder then the initial swelling that had completely disappeared after 3 or 4 days of 1st dose. It was not sore unless touched, however late yesterday on 12/30 it did get sore without touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/30/2020,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 919126,NY,54.0,F,"Pain at Injection site, overwhelming fatigue, headache, muscle/joint pains, L axillary LN, swelling - induration - erythema at injection site, nausea w/ loss of appetite started 8 hrs after injection - all Sx except fatigue, headache and arm pain / swelling / erythema resolved in 48hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,OTH,Multivitamin; Krill Oil; Vit D,None,Inter-vertebral Disc Disease,,None,"['Arthralgia', 'Decreased appetite', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy', 'Myalgia', 'Nausea', 'Pain in extremity']",1,MODERNA,IM 919127,NY,57.0,F,"Fever, Chills, Headache, Malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,SEN,,,,,,"['Chills', 'Headache', 'Malaise', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 919128,TX,58.0,F,"Chills, leg muscle aches, joint pain, fever. Fever started around noon on 1/3/21- Day after injection 1/3/21 Noon: temp 100.1, -2:25pm: temp 102.1. -4PM temp: 101.00.- 6pm temp: 100.2, -7:30pm temp: 99.2, 1/4/21 1am temp: 99.8, 7:30am temp. 97.9. Rotated Tylenol & Aleve. Drank plenty of water & Gatorade.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,OTH,"Metformin 1000 mg. twice a day, Trajenta 1 per day, Losartan1 per day, Vitamin C, Vitamin D, Symvastatin 1 per day.",None,Diabetes Type II,,None known,"['Arthralgia', 'Chills', 'Myalgia', 'Pyrexia']",1,MODERNA,SYR 919129,HI,46.0,F,"After the 15 min monitoring, I went back to work 15 min later. the left side of my face started tingling which went to a numbing feeling down the left side of my body affecting my neck, shoulder, arm, elbow and up the upper left torso. My face and neck was numb for about 48 hrs and the rest came back to sensation within 24 hrs. D/T the numbness I was admitted into the hospital for a 24hr observation.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"Losortan HCTZ, Claritin",no,Hypertension,,Vicodin,"['Blood test', 'Computerised tomogram', 'Hypoaesthesia', 'Magnetic resonance imaging', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 919130,IN,42.0,F,"Nausea, Vomiting, extreme fatigue, dizzyness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,WRK,Montelukast 10mg daily; Vitamin D; Vitamin B12; Vitamin B1,None,Asthma,,"Allergic reaction to food uncertain what, Narrowing down > Green Onions, MSG, still unsure","['Dizziness', 'Fatigue', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 919131,MI,61.0,F,"Right side mouth and tongue tingling, PO 25 mg Benadryl given Vitals signs WIL",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Norco PRN, Motrin 800mg",,Auto immune Neuropathy,,egg products in vaccines,['Paraesthesia oral'],1,PFIZER\BIONTECH,IM 919132,CO,60.0,F,"Redness, swelling, hives on entire upper arm. Hot also",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PUB,Imodium,,"Diarrhea, mild COPD",,Sulfa,"['Erythema', 'Peripheral swelling', 'Skin warm', 'Urticaria']",3,MODERNA,IM 919133,NY,36.0,F,"I received the vaccine at work Thursday {December 31st} morning, and started feeling sick that same evening. Including malaise, low grade fever..not higher than 99.6, mild sore throat, shortness of breath, dehydration/dry mouth, light-headedness/dizziness, runny nose, and coughing. These symptoms continued on and off from {12/31-and continued all throughout the weekend and continue as of today-01/04}. Fevers don't last long, they come and go. The main symptoms that are chronic and consistent are the runny nose, sore throat, shortness of breath, and feeling tired/lethargic, just low energy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,,Asthma,,,Doripenum: Rash,"['Asthenia', 'Cough', 'Dehydration', 'Dizziness', 'Dry mouth', 'Dyspnoea', 'Fatigue', 'Lethargy', 'Malaise', 'Oropharyngeal pain', 'Pyrexia', 'Rhinorrhoea']",UNK,MODERNA, 919134,IL,31.0,F,patient stated felt numbness in her left middle finger and thumb. Started feeling lightheaded and though she was going to pass out. Patient states she has needle phobia and has had this happen in the past.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,none,none,none,,none,"['Dizziness', 'Hypoaesthesia']",1,PFIZER\BIONTECH,IM 919135,CA,60.0,F,"12/18/20 08:00PM Mild headache; 12/19/20 headache resolved; chills, loose bowel movement, fatigue. 12/20/20 loose bowel movement, rash on back and disappeared face red lips swollen. 12/21/20 symptoms continued medications taken Benadryl. Imodium; rash resolved and loose bowel movements later in the day. Abd discomfort, pain and nausea present since vaccine given.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,MIL,"Synthroid, Amoxicillin, b12, Fluoxetine (low dose)",,"Thyroid, IBF",,,"['Abdominal discomfort', 'Chills', 'Diarrhoea', 'Erythema', 'Fatigue', 'Headache', 'Lip swelling', 'Nausea', 'Pain', 'Rash']",1,PFIZER\BIONTECH,IM 919136,IA,33.0,F,"7 days after vaccine developed redness, itchiness, and swelling around site of injection. This is still continuing at time of this report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/03/2021,7.0,WRK,"Hair/skin/nail vitamins, lexapro",none,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 919137,MI,37.0,F,48 hours after injection developed micro-hemorrhages in her right eye. Symptoms resolved and 12/29 recurrence of bleeding to right eye slightly worse than before.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/20/2020,2.0,PVT,none,none,none,,latex,['Eye haemorrhage'],1,PFIZER\BIONTECH,IM 919138,HI,64.0,M,Sudden profound sensorineural hearing loss-left ear,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,01/03/2021,18.0,MIL,loratadine 10 mg daily; valacyclovir 500 mg daily; tacrolimus 0.1% gel topically 1-2 times a day to affected areas,none,allergic rhinitis; vitiligo; history of prostate cancer,,none,"['Blood test', 'C-reactive protein', 'Deafness neurosensory', 'Full blood count', 'Magnetic resonance imaging brain', 'Red blood cell sedimentation rate']",UNK,PFIZER\BIONTECH,IM 919139,CA,36.0,F,"Redness, swelling and itching over vaccination site starting 1 week after administration . I have pictures of area if they would be of help.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,MIL,None,None,None,MMR,Penicillin,"['Injection site erythema', 'Injection site pruritus', 'Vaccination site swelling']",1,MODERNA,IM 919140,WI,38.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,"amoxicillin, erythromycin","['No adverse event', 'Product storage error']",1,MODERNA,IM 919141,NH,45.0,F,"Had an episode of tounge tingling and numb throat. Lasted 30 min, resolved without any treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Multivitamin,,,,NKA,"['Paraesthesia oral', 'Pharyngeal hypoaesthesia']",1,PFIZER\BIONTECH,IM 919142,TX,42.0,F,"Headache, nausea, body aches, chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/02/2021,2.0,WRK,"Blisovi, singular, aciphex, Mexolicam, Breo, Xhance, vit B12, vit D3, elderberry",None,Asthma,,None,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain']",1,MODERNA,SYR 919143,IA,67.0,F,Pt started experiencing localized redness and itching around the injection site. It was about 2inches around described by the patient. This symptom started about a week after receiving the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/30/2020,8.0,PHM,,,,,NO,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 919144,ME,25.0,F,"Fatigue, weakness, nausea, vomiting, pain in arm. As a part of hospital protocol, was tested for COVID.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,PVT,ethinyl estradiol-norgestimate,none,none,,seasonal,"['Asthenia', 'Fatigue', 'Nausea', 'Pain in extremity', 'SARS-CoV-2 test', 'Vomiting']",1,MODERNA,IM 919145,NY,25.0,F,"About 5 minutes after the injection, employee reported having had tickling/itching in throat, facial flushing, and tachycardia. A rapid response was called, and was given Benadryl. She was brought to ED for monitoring and treatment, where she received more Benadryl + Famotidine. After receiving the medications, symptoms subsided, and she was discharged home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,oral contraceptives- MiniPill,Rhinorrhea & body aches 1 week prior to vaccine. COIVD(-).,ENDOMETROSIS,,"NKDA, ALLERGY SHELLFISH ( THROAT ITCHING ) TREE NUTS/PEANUTS","['Flushing', 'Oropharyngeal discomfort', 'Tachycardia', 'Throat irritation']",1,PFIZER\BIONTECH,IM 919146,OH,32.0,F,1st 4 days extreme arm pain (woke me up from sleep). On 1/1 I noticed one enlarged lymph node on my neck. Over the next couple days my lymph nodes are multiplying and growing in size,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,WRK,,,,,Penicillin,"['Lymphadenopathy', 'Pain in extremity', 'Sleep disorder']",1,MODERNA,SYR 919147,TX,65.0,F,"I work in health care and therefore was offered the vaccine. After about 1hr my hands, feet and nose became very cold and my temp dropped to 94 degrees. I felt very cold. My blood pressure was 90/30. This never happened to me before. It took about two hours for my temp to go back to normal and for me to feel my normal self. I had Covid 19 in August.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"baby aspirin, Lisinopril 5 mg.",None,none,,shellfish,"['Body temperature decreased', 'Feeling abnormal', 'Feeling cold', 'Peripheral coldness']",1,MODERNA,SYR 919148,IN,59.0,M,"Patient received his vaccine and waited the 15 minute observation period before leaving the clinic. At 2:00 he returned to the clinic, stating to the paramedic that he felt like he was having an episode of Bell's Palsy. His vital signs were checked and were as follows: BP 169/96 mmHg, HR 72 bpm, O2 sat 99%. The patient has right sided tingling extending from the eye to the mouth. He had no visual changes. The patient was offered transport to the hospital and further medical treatment. He refused transport or treatment and left the vaccination clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,none known,none known,none known,,penicillins,"['Facial paralysis', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 919149,IN,57.0,F,On 12/22 went to the ER prescribed Prednisone still exp sob unable to walk up a flight of stairs. My reaction continued 5 days after the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,PVT,"Nasal Omnaris, Nasal inhaler Olopatadine, ToPromax, Atenolol",No,"Hypertension, Migraines, Asthma",,"Tetanus, Penicillin Sulfur, Doxycycline","['Blood test', 'Dyspnoea', 'Gait inability']",1,PFIZER\BIONTECH, 919150,OK,29.0,F,"Fever, body aches, chills, body aches and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,WRK,,,,Pertussis vaccine,,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 919151,WI,45.0,M,Patient received dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919152,TX,41.0,F,"""Pfizer-BioNTech COVID-19 Vaccine EUA."" Patient received first dose of vaccine on 12/21/2020. Patient called on 1/3/2021 to notify that she developed symptoms on 12/27/2020 and had an appendectomy on 12/28/2020 at another facility. Patient also reports that CDC V-Safe Application was used to report event as well. Patient reports that she is recovering well.",Not Reported,,Not Reported,Yes,,Not Reported,,12/21/2020,12/27/2020,6.0,PVT,,,,,,['Appendicectomy'],1,PFIZER\BIONTECH,IM 919153,,45.0,F,"right arm numbness, sensation of throat constriction and heat in her body",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Feeling hot', 'Hypoaesthesia', 'Throat tightness']",1,PFIZER\BIONTECH,IM 919154,IA,38.0,F,"Patients adverse reactions started day of vaccination with right arm pain up to right ear as well as complete tongue numbness. On 1-1-21 patient had increased Bell's Palsy symptoms including; inability to raise left eyebrow, inability to close left eye in its entirety, teeth being numb on left side, and numbness and tingling in left foot and left hand (from palm to fingers). ER physician prescribed on 1-1 Prednisone, Keflex and Valtrex. Patient went to ER again on 1-2-21 with lower extremity numbness on left side that is moving proximally toward her hip. Patient went home on 1-3-21 with an RX for Prednisone as well as Valtrex. Symptoms have improved but have not fully resolved at this time.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,Probiotic,,Crohns Disease,,"Azithromycin (patient has an upset stomach when taking), patient also has sensitivity when eating chocolate, pineapple or highly processed foods (due to Crohn's Disease)","['Computerised tomogram normal', 'Ear pain', 'Facial paralysis', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Pain in extremity', 'Paraesthesia']",1,MODERNA,IM 919155,MD,25.0,F,"Headache, fatigue, bodyaches, vomiting, chest discomfort",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,MIL,Ibuprofen,"Day of vaccination: headache, fatigue Days following: headache, fatigue, vomiting, bodyaches and chest discomfort",Gerd,,Ciproflaxin,"['Chest X-ray', 'Chest discomfort', 'Electrocardiogram', 'Fatigue', 'Headache', 'Pain', 'SARS-CoV-2 test', 'Vomiting']",1,MODERNA,IM 919156,MA,37.0,F,"10 days after administration pt noticed itchiness and small bruise at injection site. Bruise began to get larger and on day 12 patient has large area of swelling (10 inches in diameter) that is warm to touch. Small bruise at center of swelling. Pt denies fever, chills, body aches. Pt instructed to call PCP for evaluation",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/03/2021,11.0,PVT,unknown,none,unknown - passed clearance form for COVID Vaccination,,none,"['Injection site bruising', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 919157,KY,35.0,F,"Patient reported began on 12/26/2020 with soreness to left axillary /underarm area, within approx. 6 hours started having itching at site with quarter-sized knot to site, reports developed itching all over body. She contacted her primary doctor who advised her to begin taking Benadryl and applying cold compresses to the site. Spoke with patient again on 1/4/2021. she reports still had redness to area, but itching has subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/26/2020,3.0,PUB,unknown,None reported,unknown,,"Penicillin, Codeine, Latex","['Axillary pain', 'Injection site erythema', 'Injection site nodule', 'Injection site pruritus', 'Pruritus']",1,MODERNA,IM 919158,NH,61.0,F,C/O itching and redness at the site. First noticed several days after the injection was administered.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/04/2021,12.0,PVT,"Aspirin, Celebrex, Protonix, Oxycodone, Metoprolol Tartrate, Vitamin D","Atrial fibrillation, Anemia, Hyperlipidemia,",,,NKA,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 919159,TX,44.0,F,"12/19 Started with fever, congestion, headache. 12/24 additional symptoms to include body aches, cough, night sweat. 12/31 additional symptom of hypertension . As of today experiencing body aches, headache, cough, and hypertension. Medical Treatment 12/27/20 Urgent Care - 01/04/21 (virtual visit on 12/20)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/19/2020,3.0,WRK,"Zoloft, Apri, Women's Multivitamin",No,Depression,,Sulfa,"['Cough', 'Headache', 'Hypertension', 'Influenza virus test negative', 'Night sweats', 'Pain', 'Pyrexia', 'Respiratory tract congestion', 'SARS-CoV-2 test', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH,IM 919160,MS,54.0,F,Cellulitis of arm within 10 days; severe itching,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/30/2020,8.0,PVT,HCTZ 25mg daily Lorsartan 50mg daily,None,HTN,,Sulfur,"['Cellulitis', 'Pruritus']",1,MODERNA,IM 919161,MN,47.0,M,"2nd COVID vaccine given too soon. First vaccine given 12/19, second vaccine given 12/31",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/31/2020,12.0,WRK,,,,,,['Inappropriate schedule of product administration'],2,PFIZER\BIONTECH,IM 919162,,43.0,F,"Noticed a little tension to supraclavicular area, then when palpated noticed the swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/04/2021,4.0,PVT,,,,,,['Lymphadenopathy'],UNK,PFIZER\BIONTECH, 919163,MO,36.0,F,Large hive on inside of upper arm opposite side of where the injection was but same arm as vaccine evening of vaccine. Extreme fatigue following day with mild headache,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Fatigue', 'Headache', 'Injection site urticaria']",1,MODERNA,IM 919164,TX,34.0,F,"SOB day of vaccination; not critical. Flushing of ears and face roughly 9 hours after vaccination; followed by fevers 101.0-101.5 overnight. Next day chills, ?feeling of burning from the inside out bilaterally in my lower extremities,occassionally drifting to arms.? Also fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,OTH,"Sertraline, trazadone, proair",None,Asthma,,None,"['Burning sensation', 'Chills', 'Dyspnoea', 'Ear discomfort', 'Fatigue', 'Flushing', 'Influenza virus test', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,IM 919165,MA,45.0,F,"Moderate left arm pain (whole arm from shoulder to mid forearm), with movement and w/o movement. No redness or swelling. Just very tender to touch at injection site. No other symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,None,None,None,,Environmental,"['Injection site pain', 'Pain', 'Pain in extremity']",1,MODERNA,IM 919166,WI,59.0,F,"Arm started becoming sore that evening, the next day it was extremely sore even to the touch",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,"citalopram, budesonide, Advair,Montelukast, Vit D, Vit C, Vit b complex, probriotic, fish oil, Zyrtec, magnesium, zinc,",none,"asthma, depression, microscopic colitis, osteoporosis",,"sulfa, Macrobid, NSAIDS","['Pain in extremity', 'Tenderness']",UNK,MODERNA,IM 919167,AZ,68.0,M,Some pain at injection site for 24 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,None,None,None,Pain at injection site for 1-2 days,None known,['Injection site pain'],1,PFIZER\BIONTECH,IM 919169,TX,33.0,F,"Started with quarter size red, hard spot around the injection site. Increased in size to more Golf ball size as week progressed. Husband is ER physician and has been treating it at home but patient wanted to make sure it was reported via VAERS",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/25/2020,1.0,PHM,none,none known,none known,,nka,"['Injection site erythema', 'Injection site induration']",1,MODERNA,IM 919170,VA,36.0,F,Gold ball sized lump to left armpit near breast that was tender and warm to the touch. No prior issues with armpit or breast tissue. Needed to take Motrin/Tylenol for pain and swelling for two days after vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,None,Covid positive diagnosis 12/2/2020. Only symptom at time of COVID diagnosis was loss of taste and smell. Revived vaccine on 12/29/2020.,None,,None,"['Mass', 'Oedema peripheral', 'Skin warm', 'Tenderness']",1,PFIZER\BIONTECH,IM 919171,CA,57.0,F,"After sitting for 10 minutes, I became very nauseated and lightheaded and walked self to gurney near by to lie down. Medical attention was rapid and blood pressure was super low, 70/50 ish and returned to better number in Trendenlenberg position. I was sent to ER for further monitoring and all is fine now- Dx with near Syncope due to orthostatic hypotension.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Fish oil, Vitamin D, Synthroid and cytomel, Glucosamine/chondotrin.",no,hypothroidism,,sulfa drugs,"['Blood pressure decreased', 'Dizziness', 'Electrocardiogram normal', 'Nausea', 'Orthostatic hypotension', 'Presyncope']",1,MODERNA,IM 919172,WA,49.0,F,"Chills Bodyache Fever 103, 102 High blood sugar 216 This morning same symptoms as above plus clear discharge from nose like cold and unable to taste food",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PVT,None,None,Diabetes 1,,None,"['Ageusia', 'Blood glucose increased', 'Chills', 'Pain', 'Paranasal sinus hypersecretion', 'Pyrexia']",1,MODERNA,IM 919173,MA,25.0,F,"Individual had a 1.5 inch area of induration, redness and warmth in the area of the injection site. Individual went to urgent care and was placed on an antibiotic.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/01/2021,8.0,WRK,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site warmth']",1,MODERNA,IM 919174,IN,60.0,F,"States, ""Does not feel well""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,SEN,"Norvasc, Aricept, Depakote, Lexapro, Metoprolol Tartrate, Potassium Chloride, Senna","U07.1 2019-nCoV acute respiratory disease (Primary) F29 Unspecified psychosis not due to a substance or known physiological condition F33.1 Major depressive disorder, recurrent, moderate F02.81 Dementia in other diseases classified elsewhere with behavioral disturbance I70.1 Atherosclerosis of renal artery I10 Essential (primary) hypertension R41.841 Cognitive communication deficit K21.9 Gastro-esophageal reflux disease without esophagitis R53.1 Weakness R27.8 Other lack of coordination M54.5 Low back pain M62.81 Muscle weakness (generalized) R26.89 Other abnormalities of gait and mobility R26.81 Unsteadiness on feet H04.129 Dry eye syndrome of unspecified lacrimal gland Z74.1 Need for assistance with personal care C53.8 Malignant neoplasm of overlapping sites of cervix uteri (History of) E87.6 Hypokalemia M24.512 Contracture, left shoulder M24.522 Contracture, left elbow R63.3 Feeding difficulties F17.200 Nicotine dependence, unspecified, uncomplicated G47.8 Other sleep disorders K59.00 Constipation, unspecified F51.01 Primary insomnia D05.90 Unspecified type of carcinoma in situ of unspecified breast Note: Bilateral Lumpectomy (History of) R62.7 Adult failure to thrive M54.30 Sciatica, unspecified side","U07.1 2019-nCoV acute respiratory disease (Primary) F29 Unspecified psychosis not due to a substance or known physiological condition F33.1 Major depressive disorder, recurrent, moderate F02.81 Dementia in other diseases classified elsewhere with behavioral disturbance I70.1 Atherosclerosis of renal artery I10 Essential (primary) hypertension R41.841 Cognitive communication deficit K21.9 Gastro-esophageal reflux disease without esophagitis R53.1 Weakness R27.8 Other lack of coordination M54.5 Low back pain M62.81 Muscle weakness (generalized) R26.89 Other abnormalities of gait and mobility R26.81 Unsteadiness on feet H04.129 Dry eye syndrome of unspecified lacrimal gland Z74.1 Need for assistance with personal care C53.8 Malignant neoplasm of overlapping sites of cervix uteri (History of) E87.6 Hypokalemia M24.512 Contracture, left shoulder M24.522 Contracture, left elbow R63.3 Feeding difficulties F17.200 Nicotine dependence, unspecified, uncomplicated G47.8 Other sleep disorders K59.00 Constipation, unspecified F51.01 Primary insomnia D05.90 Unspecified type of carcinoma in situ of unspecified breast Note: Bilateral Lumpectomy (History of) R62.7 Adult failure to thrive M54.30 Sciatica, unspecified side",,NKDA,"['Chest X-ray', 'Full blood count', 'Malaise', 'Metabolic function test']",1,MODERNA,IM 919175,LA,32.0,M,"Employee reported chills, nausea, vomiting, rash on torso, aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,unknown,none,none,Influenza vaccine,none,"['Chest X-ray', 'Chills', 'Differential white blood cell count', 'Full blood count', 'Influenza virus test', 'Metabolic function test', 'Nausea', 'Pain', 'Rash', 'Streptococcus test', 'Vomiting']",1,MODERNA,IM 919176,WI,41.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,Augmentin,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919177,MO,46.0,M,"Mild arm soreness the next day, no other symptoms. On day 7 had noticeable redness, induration at the site of injection. Site was hot, red, swollen, but not painful. No other symptoms. Redness spreading everyday, but the induration is less.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/28/2020,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 919178,CA,55.0,F,Arm soreness Swelling Overall body feeling shaky,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,UNK,,,,,,"['Nervousness', 'Pain in extremity', 'Swelling']",1,PFIZER\BIONTECH,SYR 919179,AL,50.0,F,day 2 vaccine I woke up with rash all over my body except for face. No itch it burned with heat. day 4 petechiae on my legs. day 5 nausea with extreme pressure and fullness in the back of my neck. It felt like pressure on my head. No pain unless touch Only relief when sitting straight up. Took tylenol and ibuprofen and allegra but did have any relief. Telehealth with occupation heath.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,WRK,"mult vite C, zinc, black colash, biotin, mult collagen protein",no,no,,sulfa,"['Burning sensation', 'Full blood count', 'Musculoskeletal discomfort', 'Nausea', 'Petechiae', 'Rash', 'SARS-CoV-2 test']",1,MODERNA,SYR 919180,WI,61.0,F,"Pt received the COVID 19 Moderna Vaccine on 12/29/20. On 1/03/21 PT reported to her supervisor that she had developed symptoms and had been tested for COVID-19, which came back positive. Received bamlanivimab infusion on 1/4/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/03/2021,5.0,PVT,,,,,NKDA,"['SARS-CoV-2 test positive', 'Unevaluable event']",1,MODERNA,IM 919181,,17.0,F,"Patient stated they were 18 years old on their form, and it was later found that they were 17 years old. They should not have received the vaccine, but were given it by mistake. No serious side effects",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,SEN,,,,,,"['No adverse event', 'Product administered to patient of inappropriate age']",UNK,MODERNA, 919182,NY,49.0,F,"pain at the injection site (can barely raise my arm, fever of 100.5, mild nausea, headache, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,WRK,"Atenolol, levothyroid, symbicort, vitamin D, Allegra",none,"Asthma, hypothryoid, migraines, obesity",,Desipramine,"['Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,IM 919183,MD,46.0,F,Sore arm for a few hours. Nothing more.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,MIL,Pantoprazole Wellbutrin Zyrtec Atorvastatin,,High cholesterol,,Chia seeds,['Pain in extremity'],1,MODERNA,IM 919185,NY,38.0,M,"Extreme tiredness, extreme pain in left wrist, cannot sleep, headache, nausea, irritability, THESE HAVE BEEN GOING ON FOR A WEEK. I've had to call into work",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/28/2020,2.0,PVT,None,None,None,,None,"['Arthralgia', 'Fatigue', 'Headache', 'Insomnia', 'Irritability', 'Nausea', 'SARS-CoV-2 test negative']",1,MODERNA,IM 919187,MO,20.0,M,lightheaded,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,PVT,,,,,,['Dizziness'],1,MODERNA,IM 919188,SD,49.0,F,"headache, weakness, brain fog, confusion, dizziness. weakness in limbs",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,WRK,bisoprolol,,mildly high blood pressure,"weakness, facial numbness",penicillin,"['Asthenia', 'Confusional state', 'Dizziness', 'Feeling abnormal', 'Headache', 'Muscular weakness']",1,PFIZER\BIONTECH,IM 919189,WI,44.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,"atorvastatin, amoxicillin","['No adverse event', 'Product storage error']",UNK,MODERNA,IM 919190,TX,43.0,F,"Severe arm pain in injection site, fever (100.2), horrible leg aches and muscle pain. Felt like I had the worse case of the flu in my life. Very tired and little energy. This lasted about 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,none,none,I have chronic leg pain that has been undiagnosed for 6 years. Spent a week at the hospital 5 years ago and came home with no diagnosis. In 2019 I underwent 4 procedures for Vascular reflux diseaase to hopefully help with the leg problems but it has not helped.,,I am allergic to lyrica and symbalta,"['Asthenia', 'Condition aggravated', 'Fatigue', 'Influenza like illness', 'Injection site pain', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 919191,MA,45.0,F,Woke up with rash on my chest and stomach and partial back,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,WRK,Prozac 10mg/ Zyrtec/estradiol .5mg/ valacyclov 1gram,No,No,,"Dust, dust mites, mold, and Bactrim Septra",['Rash'],1,MODERNA,SYR 919192,CA,63.0,F,"Nausea, exhaustion, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,UNK,,,,,,"['Dizziness', 'Fatigue', 'Nausea']",2,MODERNA,IM 919193,TX,39.0,F,"01/02/2021: On 12/30/2020 Noticed swelling in the lymph nodes at my right clavicle and right ear. The clavicle node swelling continues to increase and cause soreness (neck and right arm) . 01/04/2021: The swelling/knot remains, and I have an appointment with my PCP today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/30/2020,4.0,WRK,,,,,,"['Lymphadenopathy', 'Neck pain', 'Nodule', 'Pain in extremity']",1,MODERNA,IM 919194,NJ,62.0,F,"Initially on 12/29/2020 the injection site began to itch but this subsided by the end of the Day. On Thursday 12/31/2020 I had pain, erythema and redness around the site of injection. For treatment I took an OTC Benadryl, applied hydrocortisone cream and used topical Arnicare gel for the pain. By the next day 1/1/2021 the redness was decreasing and again applied hydrocortisone cream & Arnicare gel. By 1/2/2021 the redness and erythema was improved and on 1/3/2021 it was back to normal",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/29/2020,6.0,WRK,Quinapril 20 mg BID; HCTZ 12.5mg Daily; Synthroid 25mcg Daily; Lipitor 40mg Daily; Warfarin 5mg;,None,"HTN; HLD, Hypothyroid, Coagulopathy (positive for Lupus Anticoagulant Inhibitor)",,No Known,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,IM 919195,,36.0,F,01/03/2020: Last night staff having chill and fever 101. Feeling better now. Covid test for her department will be on 01/06/2021. No exposure. Already schedule 2nd dose appointment on 01/15/2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,01/03/2021,11.0,UNK,,,,,,"['Chills', 'Pyrexia']",UNK,PFIZER\BIONTECH, 919196,MA,46.0,F,"Individual had a 1.5 inch area of induration, redness and warmth in the area of the injection site. Individual went to urgent care and was placed on an antibiotic.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site warmth']",1,MODERNA,IM 919197,NY,27.0,F,"Delayed Moderate. Myalgias several hours later, worsened myalgias in the Evening, Shivering, ""burning up"" no fever, headache, back pain, palpitations, left axillary lymph node (peach pit size) bilateral inguinal pain next day. Symptoms improved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,PVT,,,,,,"['Back pain', 'Chills', 'Feeling hot', 'Groin pain', 'Headache', 'Lymphadenopathy', 'Myalgia', 'Palpitations']",1,PFIZER\BIONTECH,IM 919199,ME,52.0,F,"Initial quarter size erythema and soreness on the day after shot ( 12/24/20). Erythema continued, while soreness abated, but on day 8 (12/30/20), site became itchy and slightly swollen. Took Benadryl that night. On 12/31/20, woke up with zero itch, but erythema had enlarged to 3 x 3 inches and was vey swollen and hard. Contacted my PCP, Supervisor and HR to let them know. Got in to see PCP that same day at noon.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,"Tamoxifen, famotidine (prn)",,Breast Cancer 2015,,Cipro Docetaxel,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 919200,WA,46.0,F,"After taking Moderna COVID-19 Vaccine EUA: About 10 minutes after injection, I noticed a slight lightheadedness, slightly increased heart rate yet I was already anxious, and a very faint tingling in lower lip and end of tongue. Between 1-2 hours after injection, I noticed a little bit of a scratchy throat, increased thirst, and mild headache. No treatment required. I took Benadryl and Tylenol when I returned home from my shift at work about 4 hours after the injection. The next day, 1/3/21, scratchy throat had disappeared. I felt tired, slight fever of 99.5, increased thirst, and very sore arm. On 1/4/21, I just have slightly sore arm and a little tired with no fever. I took Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,Losartan 25 mg Zioptan Latanoprost Claritin Vit D3 5000 IU Vit C 1000 mg Multi-Vitamin,None,Hypertension Ocular Hypertension,,Medication - Ultram,"['Dizziness', 'Headache', 'Heart rate increased', 'Limb discomfort', 'Paraesthesia oral', 'Thirst', 'Throat irritation']",1,MODERNA,IM 919201,MO,37.0,F,"On day 8 my injection site became raised, hard, red, hot, et half-dollar in size. I applied ice to the area that day. Within 3 days it was completely gone. It did not hurt unless I touched it.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/31/2020,8.0,PVT,,,,,"Imitrex, SSRI's","['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 919202,IN,87.0,F,Dizziness and HTN; Monitor B/P and Neurological checks Q 4 hours x 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,SEN,"Colace, Miralax, Ocuvite","U07.1 2019-nCoV acute respiratory disease (Primary) J44.9 Chronic obstructive pulmonary disease, unspecified G30.1 Alzheimer's disease with late onset J43.9 Emphysema, unspecified F41.1 Generalized anxiety disorder G89.29 Other chronic pain R13.11 Dysphagia, oral phase I10 Essential (primary) hypertension K21.9 Gastro-esophageal reflux disease without esophagitis M15.9 Polyosteoarthritis, unspecified M41.9 Scoliosis, unspecified M81.0 Age-related osteoporosis without current pathological fracture M62.81 Muscle weakness (generalized) R26.81 Unsteadiness on feet R26.89 Other abnormalities of gait and mobility R27.8 Other lack of coordination R29.3 Abnormal posture K59.00 Constipation, unspecified (History of)","U07.1 2019-nCoV acute respiratory disease (Primary) J44.9 Chronic obstructive pulmonary disease, unspecified G30.1 Alzheimer's disease with late onset J43.9 Emphysema, unspecified F41.1 Generalized anxiety disorder G89.29 Other chronic pain R13.11 Dysphagia, oral phase I10 Essential (primary) hypertension K21.9 Gastro-esophageal reflux disease without esophagitis M15.9 Polyosteoarthritis, unspecified M41.9 Scoliosis, unspecified M81.0 Age-related osteoporosis without current pathological fracture M62.81 Muscle weakness (generalized) R26.81 Unsteadiness on feet R26.89 Other abnormalities of gait and mobility R27.8 Other lack of coordination R29.3 Abnormal posture K59.00 Constipation, unspecified (History of)",,"buspirone, Fosamax, Hydrocodone Compound, nabumetone, Neurontin, nitrofurantoin macrocrystal, sulfamethoxazole-trimethoprim, trimethoprim, Vitamin D Analogue","['Dizziness', 'Hypertension']",1,MODERNA,IM 919203,TX,73.0,M,none after 15 minutes no symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,none,none,none,,none,['No adverse event'],1,PFIZER\BIONTECH,SYR 919204,,35.0,M,"12/30/2021 Started having covid symptoms; headache, body pain, no taste, shortness of breath, fever cough.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/30/2020,8.0,UNK,,,,,,"['Ageusia', 'Cough', 'Dyspnoea', 'Headache', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 919206,AL,44.0,F,"fever, chills, body aches, nausea, diarrhea, and headache started around 12am 12/30/2020 and lasted until 1/1/2021. Rash on face, neck, arms and itching and burning on the palms of my hands and feet began around 2:30 am on 01/01/2021 and lasted until 01/02/2021. Still experiencing fatigue and headache as of 1/4/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,PVT,none,none,none,,penicillin,"['Burning sensation', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pruritus', 'Pyrexia', 'Rash']",UNK,MODERNA, 919207,MD,45.0,F,24hr extreme malaise (charley horse left calf) left arm pain 24hr temporal headache 24hr,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,MIL,Propafenone Diltiazem ER Ambien Lexapro Maxalt Emgality Inj (last dose 11/2020- no longer taking),Dx of Right hand/arm CPRS,Migraines Arrhythmias Insomnia CPRS,,Flecainide,"['Headache', 'Malaise', 'Muscle spasms', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 919208,WI,64.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919209,OR,60.0,F,"6th day of off/on low grade fever, fatigue, muscle aches, joint aches, headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,WRK,"Daily med/supplements Levothyroxine 175mcg , Dexedrine 10mg , multi vitamin, fish oil, low dose aspirin, magnesium, vitamin D, Sam-e, probiotic",Hashimoto thyroiditis,Hashimoto thyroiditis,,"sulfa drugs, bee stings","['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 919210,TX,23.0,F,COVID VACCINE: I began with a discomfort in my axillary area. Then it got worse and has caused swelling on my axillary area and upper left chest area. I have lost ROM on my left arm and seen a provider to get anti-inflammatory medication.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/02/2021,6.0,PVT,Celexa 40 mg,none,none,,none,"['Discomfort', 'Injected limb mobility decreased', 'Oedema peripheral', 'Swelling']",1,MODERNA,IM 919211,,41.0,F,"41 y.o. female presents to the ED with concern for possible allergic reaction to Moderna COVID-19 vaccine that she had received approximately an hour prior to arrival. Patient reports that shortly after receiving her vaccine in her left arm she developed the sensation of her throat closing and a ""film ""in the back of her throat. Patient has also reported feeling nauseated and having a throat clearing cough. No chest pain, headache, abdominal pain or development of a rash. Injection site appears to be unremarkable. Patient is given some antihistamine medications as well as steroids and observed here in the ED. The patient has improvement in her sensation of her throat closing and is able to be discharged. I discussed with the patient the usefulness of continued antihistamines over the course of the next few days and would likely advise on not receiving the second COVID-19 vaccine based on her reaction to the first. Discussed with the patient the use of epinephrine and EpiPen as needed. See discharge instructions. Patient is discharged home with her sister in improved condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"duloxetine, pancreatic enzymes, probiotic blend",,"Chronic fatigue syndrome, Hashimoto's thyroiditis, anxiety","Flu vaccine (last year, reaction lasted several days)",Historical adverse reaction to morphine (reaction nausea/vomiting),"['Coating in mouth', 'Cough', 'Nausea', 'Throat clearing', 'Throat tightness']",UNK,MODERNA, 919212,NJ,59.0,F,5 days after receiving first covid vaccine swelling and redness at injection site . site warm to touch and swelling in left axillary area. Discomfort when raising left arm. Called my primary care physician Dr. and reported . Primary care placed me on Zpak for 5days and also instructed me to take advil 200 mg 2 tabs twice per day. Instructed to call him 1/8/2021 to see if symptoms resolved. He was not sure if vaccine related but due to the swelling at site and swelling in axillary area possible cellulitis. instructed by PCP to report event to VAERS.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/02/2021,5.0,PVT,Ramipril 10 mg po daily Vitamin D3 5000 international units daily multivitamin 1 tablet po daily xanax 0.25 mg po prn,None,Hypertension,,No,"['Injected limb mobility decreased', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Limb discomfort', 'Oedema peripheral']",1,MODERNA,IM 919215,IA,43.0,F,Hives,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,WRK,Effexor Lisinopril,None,Hypertension Depreasion,,Neomycin Sulfa,['Urticaria'],1,PFIZER\BIONTECH,SYR 919216,TX,43.0,F,"Pounding heart, fast breathing, warm/tingling in arms/hands, feeling like I might faint.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,Slynd collagen vitamin D,none,none,,none,"['Dizziness', 'Feeling hot', 'Palpitations', 'Paraesthesia', 'Respiratory rate increased']",1,PFIZER\BIONTECH,IM 919217,NH,45.0,F,"After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm and leg for 20 minutes but neck and face numbness continued 12/25-12/27. Continued with facial numbness on 12/26. Called Occupational Health on 12/28 and stated that she had thigh numbness, no other Covid symptoms. Sent for testing and was negative. On follow up on 12/29, had fatigue, diarrhea and weakness, and on 1/1 still had thigh numbness and extreme fatigue, no diarrhea. By 1/3/21, had fingertip numbness on left hand, pain on her left arm and chest pressure and burning. Went to ER on 1/3 where she had a full workup for myelitis, MRI, C spine, T spine and brain, CBC, CMP, ESR. Treated with toradol and prednisone in ER and discharged. Currently on 1/4 improved muscle weakness but ongoing fatigue taking four day course of prednisone to follow up with PCP. A second dose of the vaccine scheduled on 1/11/21 will be on hold until PCP clearance. Current diagnosis decompensation of raynauds disease due to vaccine reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,WRK,"Prednisone 60 mg on 1/3, 1/4, 1/5, 1/6.",,Raynaud's Disease Heart Murmur Mitral Valve prolapse,Flu Vaccine,Clindamycin,"['Asthenia', 'Blood creatine phosphokinase normal', 'Chest discomfort', 'Chest pain', 'Condition aggravated', 'Diarrhoea', 'Fatigue', 'Full blood count normal', 'Hypoaesthesia', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging spinal normal', 'Metabolic function test normal', 'Muscular weakness', 'Pain in extremity', 'Paraesthesia', ""Raynaud's phenomenon"", 'Red blood cell sedimentation rate', 'SARS-CoV-2 test negative', 'Vaccination complication']",1,PFIZER\BIONTECH,IM 919218,MO,37.0,F,"On day 8 my injection site became raised, hard, red, hot, et half-dollar in size. I applied ice to the area that day. Within 3 days it was completely gone. It did not hurt unless I touched it.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/31/2020,8.0,PVT,,,,,"Imitrex, SSRI's","['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 919220,NC,63.0,F,"Pt received COVID19 vaccine and was observed for 15 minutes afterwards and no immediate reaction occurred. As pt was walking to her car to leave she noted that she was very thirsty and she attempted to drink water in her car but felt a constant need to swallow with a feeling of PND. She returned to the observation area in the health dept. Vital signs obtained and elevated BP 204/99, HR 104, R 20 even and unlabored. Denied tongue swelling and no facial edema noted. Denied difficulty breathing. Continued to swallow water successfully but still had a feeling of PND. No coughing noted and denied having any illness prior to injection. Does have a history of chronic sinusitis and asthma but no recent problems noted. Pt given Benadryl 50mg p.o. and friend was called for transport. Continued to monitor for 1 hr before leaving with friend.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,None,None,None,,Unknown Allergies,"['Blood pressure increased', 'Dyspnoea paroxysmal nocturnal', 'Feeling abnormal', 'Thirst']",1,MODERNA,IM 919221,MA,65.0,M,"Received the shot at 7:30 am, around 3:30 started to feel really tired with mild headache. around 5:30 pm headache got worse. So I took a couple of Tylenol went to bed got up for work at 9:15 pm. felt fine. Went to work and around 4am I noticed my left arm at the injection had a sharp pain around the injection site of my left arm. pain was a 9 out 10 when moving arm. The headache returned with chills and fatigue. When I got home around 7:45 am I took my temp with a Tympanic Thermometer which read 99.7 F. Stayed on the couch most of the day. Took Tylenol but my temp never went below 100.0 F. 10pm my temp was 100.5 all the above Sx. Then at 2am all SX completely subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"D3, Nicen, Omega 3, Multi vits",None,"High cholesterol, multi prostate surgeries, sick sinus syndrone",,All statins,"['Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pain']",1,MODERNA,IM 919222,CA,35.0,F,"macolopapular rash on the legs, no treatment given besides antihistamines",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,12/28/2020,1.0,PVT,"levothyroxine, quetiapine qhs",ended up having COVID diagnosed on 1/2/20 after her husband tested positive - she did have tests 12/26/20 and 12/31/20 which were negative,"hypothyroidism, depression/anxiety, short PR interval",,nkda,"['COVID-19', 'Exposure to SARS-CoV-2', 'Rash', 'Rash maculo-papular', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 919223,FL,38.0,M,Left thumb swelling and tenderness. Pain and restricted movement in the left hand joints.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/18/2020,2.0,PVT,None,None,None,,None,"['Arthralgia', 'Mobility decreased', 'Peripheral swelling', 'Tenderness']",1,PFIZER\BIONTECH,SYR 919225,TX,47.0,F,"inj site is warm, has redness and mild itching that began 1 week after vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/03/2021,8.0,PVT,levothryxine 100mcg daily,none,none,,latex,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 919226,RI,27.0,F,"On the evening of the vaccine, I developed a fever, chills, body aches, and fatigue. These symptoms started about 5-6 hours after receiving the vaccine and subsided by the morning after.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",1,MODERNA,IM 919227,CA,34.0,M,I had fever 100.8 and then it went to 104.7. I took a fever reducer for 2 1/2 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/23/2020,3.0,UNK,No,No,No,,No,"['Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 919229,IN,22.0,F,tingling and then swelling of the tongue 25 minutes after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Acutane and birth control pills,none,none,,NKA,"['Paraesthesia oral', 'Swollen tongue']",1,MODERNA,IM 919230,TX,41.0,F,She was hospitalized on 01/04 but exact situation unknown. COVID +. Hospitalized at Medical Center.,Not Reported,,Not Reported,Yes,,Not Reported,N,12/18/2020,12/26/2020,8.0,OTH,,,,,no,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH,IM 919231,MO,55.0,F,lips tingling,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,PVT,,,,,,['Paraesthesia oral'],1,MODERNA,IM 919232,CT,27.0,F,"Developed a red rash around injection site. Mild redness for the first few days after administration which appeared to be resolving if not already resolved when it began to worsen about one week after administration. Now warm to touch, skin is tense and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/03/2021,7.0,PVT,Isotretinoin 20 mg daily,None,None,,Penicillin - rash as a child,"['Erythema', 'Injection site rash', 'Pruritus', 'Rash', 'Rash erythematous', 'Skin tightness', 'Skin warm']",1,MODERNA,IM 919233,VT,15.0,M,Covid-19 vaccine was administered to individual < 18 years of age in error. No adverse event was observed or reported.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 919234,SC,49.0,F,"On 1/3 around 2 am , I got up to get something to eat and drink. The taste of food , feels/ taste like cotton on the left side of my mouth/ tongue. As the day progress, I noticed I am having numbness left side of my face and mouth, unable to sip from a straw on the left side of my mouth, I am having facial droop that prompted me to to the ER . At ER same day my left eye is not blinking as my right eye. I was prescribed to take antiviral , steroids and eye meds. TODAY- 1/4/21, I am still having same symptoms and my left eye , feels grainy/ needle pricking inside. Left eye vision more blurry.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,01/03/2021,16.0,UNK,Amlodipine 5 mg po daily,Plantar fascitis,"HTN, Vertigo, Seasonal allergies",,NKA,"['Abnormal sensation in eye', 'Corneal reflex decreased', 'Facial paralysis', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Taste disorder', 'Vision blurred']",UNK,PFIZER\BIONTECH,IM 919235,WI,64.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919236,OH,61.0,F,"Day 1 post: muscle pain in arm. Day 2 post:Muscle pain in arm, unable to raise arm vertically. Excessive pain in upper part of arm. (injection given very close to the top of arm near joint). Also pain in shoulder & right side of neck. Headache behind right eye. Day 3 post: muscle pain in arm. massive diarrhea in late PM. Headache behind right eye all day, mild arm pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/31/2020,11.0,WRK,,,,flu-mild flu like symptoms,,"['Arthralgia', 'Diarrhoea', 'Headache', 'Injection site pain', 'Mobility decreased', 'Myalgia', 'Neck pain', 'Pain in extremity']",1,MODERNA,IM 919237,TX,38.0,F,"Redness, swelling and large, tight, fluid-filled vesicles developed at the injection site-- this began 59 hours after receiving the vaccine. One week after receiving the vaccine, the fluid-filled vesicles are still present.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,OTH,Taytulla,,,,"food allergy to walnuts, pineapple, strawberry and bananas-- causes tongue to swell","['Injection site erythema', 'Injection site swelling', 'Injection site vesicles']",1,MODERNA,IM 919238,TX,34.0,F,"12/31/20, 1:30 PM: I RECEIVED THE SHOT. 12/31/2020, 4:00PM: I HAD SEVERE FATIGUE AND FELL ASLEEP. I DID NOT WAKE BACK UP FOR 17 HOURS. 1/1/2021, 9:00AM: WHEN I WOKE UP I HAD A LARGE RED RASH OVER MY FACE AND DOWN MY NECK- NO WHERE ELSE ON MY BODY BESIDES MY FACE. MY FACE HAD A BURNING SENSATION AS IF IT WERE ON FIRE. 1/2/2021: BY 48 HOURS MY ENTIRE FACE (INCLUDING MY EYELIDS) HAD THE RED RASH. I TOOK BENADRYL AND THE BURNING SENSATION WENT AWAY BY THE MORNING. 1/3/2021: ON DAY #3 I USED A POISON IVY TYPE CREAM BEFORE BED, AS WELL AS BENADRYL. 1/4/2021, 05:00: THE MORNING OF DAY#4 THE REDNESS AND RASH HAD SUBSIDED TREMENDOUSLY, HOWEVER STILL PRESENT. 1/4/2021, 1:30PM: VISITED HEALTH CARE PROVIDER. I HAD A STEROID SHOT ADMINISTERED, AND WAS SENT A PRESCRIPTION FOR AN EPI PEN AND A ""PACK"" TO MY PHARMACY. THE PHYSICIAN REACHED OUT TO OTHER COLLEGUES, ALL STATING THAT THEY HAD HEARD OF CASES ARISING WITH RED RASHES ON PEOPLES FACES, BUT NONE OF THEM HAD PERSONALLY SEEN IT YET. MY PHYSICIAN SAID I WAS THE FIRST PERSON TO COME IN. I ASKED ABOUT MY DERMA- FILLERS, AND IF THEY HAD ANYTHING TO DO WITH THE RASH BUT NOTHING COULD BE CONFIRMED. MY TEMPERATURE WAS EXACTLY 98.5, HOWEVER THE DR STATED MY SKIN WAS HOT TO THE TOUCH.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,,,,,PHENERGAN (IV FORM ONLY),"['Burning sensation', 'Eyelid rash', 'Fatigue', 'Hypersomnia', 'Rash', 'Rash erythematous', 'Skin warm']",1,MODERNA,IM 919239,CO,56.0,F,"pt states large red hard knot on tricep area of right arm that became hot to touch about a day after her vaccine, she states that it started at the injection site. Swelling has decreased but redness, itching and small hive appearing areas are spreading. States that ice packs and hydrocortisone cream help decrease the itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,MIL,"Toisent, metformin",none,"pre-diabetes, hypothyroidism, asthma",,Synthroid,"['Injection site erythema', 'Injection site induration', 'Injection site mass', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 919240,MO,41.0,F,"That night in the middle of the night I woke up with my right arm that my shot was given in was very sore and I could barely lift it up. The next morning 12/22/20 I woke up with a fever of 100.0 and feeling achy, and a Headache. By that same evening my fever spiked up to 102.9, migraine, body aches, and my arm still very sore. Fever not relieved by ibuprophen or Tylenol. The next am 12/23/20, my fever still 102.5 and same symptoms as day before. My fever did not go down until midnight that night and it broke and my temp was 99.1 throughout that day (12/24/20) until that late afternoon when it finally went to 98.6. Symptoms resolved and migraine gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/22/2020,1.0,PVT,,,MS,,Morphine and Oxycodone,"['Headache', 'Injected limb mobility decreased', 'Migraine', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SC 919241,,57.0,F,57 y.o. female who presents to the ED with an allergic reaction to the Moderna COVID-19 vaccine. She had symptoms of lightheadedness and dizziness and thickening in her throat. I did not see any angioedema on her uvula or lips. She points to her throat feeling slightly tight. She was given epinephrine with improvement as well as Benadryl and steroids. She is given a prescription for steroids and is instructed to premedicate with Benadryl and steroids prior to her next vaccination which she should coordinate with employee health. An EpiPen was also prescribed for her as needed. She is to return for any worsening.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"lorazepam, multivitamin, and rizatriptan",,"History of migraines, depression, GERD, multiple myeloma (diagnosed in 2008 but not receiving treatment now)",,Sumatriptan (reaction agitation),"['Dizziness', 'Throat tightness']",UNK,MODERNA, 919242,MI,30.0,F,golf ball size red area at site of injection several days after injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/03/2021,8.0,PVT,none,Nausea and fatigue around Dec 6 -had Negative covid test,none,,none,['Injection site erythema'],1,MODERNA,IM 919243,TX,29.0,F,"Employee became diaphoretic, complained of SOB and tingling from the feet up to her head. She was hypertensive at 159/105, and tachycardic at 115.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Unknown,None,None,,PCN,"['Dyspnoea', 'Hyperhidrosis', 'Hypertension', 'Paraesthesia', 'Tachycardia']",1,MODERNA,IM 919244,WI,36.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,"vitamin D, Bupropion, steristrip","['No adverse event', 'Product storage error']",1,MODERNA,IM 919245,RI,27.0,F,"On the evening that I received the vaccine I developed a fever, chills, body aches, and fatigue. The symptoms had subsided by the next morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",1,MODERNA,IM 919246,FL,31.0,M,"Hives on trunk and neck, started 72 hours after vaccine still present",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/27/2020,3.0,WRK,Omeprazole,None,None,,None,['Urticaria'],1,MODERNA,IM 919247,IA,33.0,F,"Symptoms - Felt hot and nauseas, difficult to swallow, itchy skin. Vax admin said I had red patches on face. Took vitals. Administered Benadryl. Monitored for 1.5 hours. Still itchy. Went home, took more Benadryl. Itchiness subsided by the following day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,Birth control pills,None,"Exercise induced asthma, seasonal allergies",,None,"['Dysphagia', 'Erythema', 'Feeling hot', 'Nausea', 'Pruritus']",UNK,PFIZER\BIONTECH,IM 919248,WA,46.0,F,"Moderna COVID-19 Vaccine EUA: On 1/2/21, after the injection about 10 minutes later, I felt slightly light headed with increased heart rate (I was already anxious). I noticed a faint tingling in my lower lip and end of tongue. No treatment was done. I had a slightly scratchy throat that started about an hour or so after the injection. After my shift when I returned home, I took Benadryl and Tylenol. I did notice an increase in my thirst. On 1/3/21, I had a slight fever of 99.5, tired, and a very sore arm. I continued with Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,Losartan Latanoprost Zioptan Vit D3 Vit C Multi-Vitamin Claritin,No,Hypertension Ocular hypertension,,Medication - Ultram,"['Dizziness', 'Fatigue', 'Heart rate increased', 'Pain in extremity', 'Paraesthesia oral', 'Pyrexia', 'Thirst', 'Throat irritation']",1,MODERNA,IM 919250,CA,,F,"Patient received the covid vaccine on 12/22/2020. c/o new onset of sore throat and bodyache on 1/4/2021. Denies, fever, cough, any ocular or GI symptoms. Found out today, 1/4/2021 co-worker tested positive for Covid on 12/15/2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,01/04/2021,13.0,UNK,,,,,,"['Oropharyngeal pain', 'Pain']",UNK,PFIZER\BIONTECH, 919251,NY,49.0,F,"Patient complained of dizziness 5 minutes post vaccination. Her BP was 150/99 mm/Hg after 10 minutes her BP decreased to 134/88 mm/Hg then to her baseline after 15 minutes of 126/85 mm/Hg. She had a prolonged observation of 30 minutes and was discharges feeling better, not dizzy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,,,,,Mango flavoring agent,"['Blood pressure increased', 'Dizziness']",1,MODERNA,IM 919252,ME,27.0,F,"Employee received COVID 19 vaccination at 9:45am on 12/30/20. ~15 min. later she developed a rash down her left arm, then down her Rt. arm. about 4 hours later she decided to go to the emergency room for Hearty Palpitations, Fever, Chest discomfort and feeling of generalized sunburn. Later developed severe headache..",Not Reported,,Yes,Yes,6.0,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,unknown,unknown,unknown,,NKA,"['Chest discomfort', 'Headache', 'Palpitations', 'Pyrexia', 'Rash', 'Skin discomfort']",1,MODERNA,IM 919253,CA,35.0,M,I had a fever of 100.8 that increased to 104.7,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/23/2020,3.0,UNK,No,No,No,,No,"['Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 919254,PA,34.0,F,I had flu like symptoms and strong fatigue for about 24hr after the vaccination but I got 10hr worth of sleep and was fine the next day. EDD-8/31/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,Prenatal vitamins,12/2020- COVID positive,no,,No,"['Fatigue', 'Influenza like illness']",1,MODERNA,IM 919255,MA,37.0,M,I had really strong aches that woke me up in the middle of the night. I took pain meds in the morning and have a 100.5/100.6 fever all long. I took meds twice but fever would not break. It eventually decreased around 7pm that evening and was back to normal around 9pm. I also had nausea and dizziness. Experienced palpitations during following days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,WRK,Emgality Topiramate,COVID about a month prior. Around Nov 18th and lasted for about 2 weeks.,,,Penicillin,"['Dizziness', 'Nausea', 'Pain', 'Palpitations', 'Pyrexia']",1,PFIZER\BIONTECH,IM 919257,MO,46.0,F,Developed red rash in the region where the vaccine was administered. It started out very small and has progressively gotten larger in size. Measures approximately 4 x 2.5 in. This is warm to the touch. It is red and blotchy.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/31/2020,8.0,PVT,,,,,Sudafed,"['Injection site erythema', 'Injection site rash', 'Injection site warmth', 'Rash erythematous', 'Rash macular']",1,MODERNA,IM 919258,CT,38.0,F,"1 week after vaccination with Moderna Covid vaccine, patient experienced itching at vaccination site, swelling and tenderness of arm and armpit area. Resolved without treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,PUB,multivitamin,None,None,Patient reported mother told her she needed to get half doses of vaccines as a child,penicillin,"['Axillary pain', 'Injection site pruritus', 'Injection site swelling', 'Pain in extremity']",1,MODERNA,IM 919259,WI,59.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,Walnuts,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919260,CO,26.0,F,"12/23/2020 I had diahrrea for two hours at 5pm, abnominal pain, I went to the ER and had a consult for the 24th and see if I could get my gallbladder out for previous problems, I had chest pain, they did emergency surgery that same day and they removed my gallbladder. I have a rash on my injection site, I think it's a christmas tree rash .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,"Armour, varetec, fisequafin, simbalta, topamax, zyrtec, cingular, omeprazole","gallbladder,","Chronic Gastritis, asthma, hypothyroidism, migrains, low libido",arm pain,"sulfa, sudafed, propofal, soy, tomatoes, environmental, animals","['Abdominal pain', 'Chest pain', 'Cholecystectomy', 'Diarrhoea', 'Injection site rash', 'Laboratory test normal']",1,MODERNA,SYR 919261,MT,76.0,M,"Individual reports ""woke up with red rash and itching"" Took benadryl and applied topical itch ointment Did improve but still with red rash at 1100 on 12/30/2020",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,PVT,Unknown,Unknown,HTN/CAD/ED/Hyperlipidemia/Gout,,morphine reaction N/V,"['Pruritus', 'Rash erythematous']",1,MODERNA,IM 919262,KS,46.0,F,"Red blotches on neck, itching, dizzy, arm ""flaming red,"" trouble breathing, blisters on lips, eyes swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PUB,Omeprazole Contrave Tylenol,None,None,influenza shot (hives and itching); patient was about 34 years old at the time.,Codeine Bactrim Mushrooms Blueberries Strawberries Raspberries Fish,"['Dizziness', 'Dyspnoea', 'Erythema', 'Eye swelling', 'Lip blister', 'Pruritus', 'Rash macular']",1,MODERNA,IM 919263,CO,63.0,M,"I had a slight sore throat on night of getting vaccine. On the day after, I had chills, body aches, chest tightness and pain, shortness of breath and Wheezing.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,"Potassium Chloride, Fluoxetine , Montelukast, Clonazepam, lisinopril/HCTZ, lansoprozole,gabapentin, Tramadol, Savella, Amlodipine, Linzess, Vit D3","HTN, depression, fibromyalgia, anxiety, GERD, Chronic pain, fatigue, Chronic constipation, asthma, Osteoarthritis",all of the above,,Narcotics make me itch,"['Chest discomfort', 'Chest pain', 'Chills', 'Dyspnoea', 'Oropharyngeal pain', 'Pain', 'Wheezing']",1,MODERNA,IM 919264,MD,45.0,F,"itching both thighs, mild h/a, sinus pressure",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,"Brio, Singular, Flonase,Zyrtec",asthma,asthma,,seasonal allergies,"['Headache', 'Paranasal sinus discomfort', 'Pruritus']",1,PFIZER\BIONTECH,IM 919265,MO,46.0,F,Developed red rash in the region where the vaccine was administered. It started out very small and has progressively gotten larger in size. Measures approximately 4 x 2.5 in. This is warm to the touch. It is red and blotchy.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/31/2020,8.0,PVT,,,,,SUDAFED,"['Injection site erythema', 'Injection site rash', 'Injection site warmth', 'Rash macular']",1,MODERNA,IM 919266,FL,46.0,F,"""Moderna COVID-19 Vaccine EUA"" Inability to sleep(insomnia), Upset stomach, Diarrhea, soreness at injection site for 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,Synthroid,none,none,,pennicillin,"['Abdominal discomfort', 'Diarrhoea', 'Injection site pain', 'Insomnia']",UNK,MODERNA,IM 919268,OH,51.0,F,"Within an hour of the vaccine, she became tachycardic and is has steadily been increasing.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Topamax, estradil, levothyroxine.",no.,"Thyroid disease(hypothyroidism), migraines, and post menopausal.",,"Avelox, and Sulfa",['Tachycardia'],1,MODERNA,IM 919269,MN,22.0,F,I received the Moderna Vaccine on 12/28/2020. I had no immediate reactions. By 6-7pm that night I started having severe pain in my right arm. The next morning 12/29/2020 I woke up with a migraine and still had severe pain in my arm. That night (12/29/2020) I began feeling aches and pains throughout my body and felt that into the next morning (12/30/2020). The evening of 12/30/2020 I noticed a dollar coin sized red spot on my arm that was warm to the touch and was slightly raised. (By this time my arm pain had decreased but was still present.) The red spot had grown slightly by 12/31/2020 but not much. Friday 01/01/2021 I hadn't payed much attention to the spot but it looked the same. The morning of 01/02/2021 I woke up and had noticed that the spot had taken over a large portion of the outer bicep on my right arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,SEN,,,Migraines,,Nickel,"['Migraine', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Skin abrasion', 'Skin warm']",1,MODERNA,IM 919270,IA,28.0,F,"pruritis, erythema, and swelling around injection site; felt like a bug bite, and progressed to become larger, red, and warm to touch",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,01/03/2021,8.0,PVT,"Prozac, vit D, prenatals",none,asthma,,"silicone, nickel, sulfa, augmentin, phenytoin","['Erythema', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Pruritus']",1,MODERNA,IM 919271,TX,57.0,F,"Day 1 after vaccination, left arm achy, sore, left wrist/left hand swelling, deep ache to left hand wrist, left eye floater, blurry vision. Day 2 after vaccination, continued with same symptoms, left eye ""puffiness"". 1/4/2021Today continues with left eye floater and constant blurry vision. Left hand soreness to and left shoulder",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,WRK,Multivitamins,none,none,,NKA,"['Eye swelling', 'Pain in extremity', 'Peripheral swelling', 'Vision blurred', 'Vitreous floaters']",1,MODERNA,IM 919272,IL,38.0,F,"Approx 10 minutes after vaccination, she felt very dizzy with elevated heart rate and BP. Was given Benadryl 50mg po. Vital signs monitored. Laid on floor for approx. 30 minutes. After she returned to work post vaccination (she is a nurse), she again started feeling bad and was monitored there also.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PUB,,,,,,"['Aura', 'Blood pressure increased', 'Computerised tomogram', 'Dizziness', 'Electrocardiogram ambulatory', 'Feeling abnormal', 'Heart rate increased', 'Hypoaesthesia oral', 'Influenza virus test negative', 'Laboratory test normal', 'SARS-CoV-2 test', 'Tremor']",1,MODERNA,IM 919273,ID,39.0,F,"Starting just a few hours after the immunization I had a red swollen rash around the injection sight, about the size of a nickel. It was painful, but not anymore then a regular flu immunization. I thought I was possibly just reacting to the bandage. However, by the end of the night the redness and swelling had grown to about the size of a silver dollar. The next morning it had swollen to the size of a baseball, was red inflamed and warm to the touch. It only itched when it was touched by something, but was quite sore. I tried some Benadryl cream and took my normal allergy pills I also started using an ice pack trying to keep the heat and swelling down. None of this seemed to help. I also started to feel dizzy and had a headache, normal reactions to immunizations. I did sleep off and on all day this first day after the immunization as I felt weak and dizzy. The swelling just kept getting larger and large no matter what I tried. The second day after the immunization the swelling was around the size of a soft ball, and it was very red, inflamed and almost hot to the touch. Again I used Zyrtec, Benadryl cream and also tried a washcloth soaked with witch hazel, this did not seem to help. Later I went to a friends house and she had some Triamcinolone cream and colloidal silver, I tried both of these and the swelling and warmth did start going down. The redness has stayed about the same (now about the size of a grapefruit). It has started itching, but not constant, and not like my typical allergy itch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Zoloft 150mg, Low dose birth control, Zyrtec",Sinusitis,Asthma,,"Eggs, latex","['Dizziness', 'Fatigue', 'Headache', 'Inflammation', 'Injection site rash', 'Pruritus', 'Rash', 'Rash erythematous', 'Rash papular', 'Skin warm']",1,MODERNA,IM 919274,MO,40.0,F,Received vaccine 12/23/20. Developed rash on belly 1/1/20 that spread to full body rash by 1/4/20. Developed body aches 1/3/20.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/01/2021,9.0,PUB,"Trazodone, Losartan, Mobic, Tylenol.",None.,Chronic cough,,"NKDA, NKFA","['Pain', 'Rash']",1,MODERNA,IM 919275,WY,43.0,F,"I started with fatigue on 12/24/20 and on 12/25/20 developed fatigue and chills (could not get warm). On 12/25/20 I was walking downstairs when my husband felt I didn't look normal. I fell off the bottom two stairs sustaining injury to both feet. I was able to get myself up to standing position and then sat down. My husband reports that a few minutes later I had what he described was seizure activity for about one minute/stopped breathing and he called 911. Due to COVID visitor restrictions my husband was not allowed to go to the ER with me the night of the incident. I had full work-up with labs, EKG and head CT that were unremarkable at Medical Center. I had an appointment with my primary care physician on 12/28/20 and was referred to neurologist. He did an exam, ordered MRI and sleep deprived EEG. My MRI was completed and reported as no abnormalities. I have the sleep deprived EEG scheduled on 1/11/21. I have continued pain/physical therapy on both feet/ankles from the date of the incident.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/25/2020,2.0,OTH,Effexor XR 37.5mg daily for migraine prophylaxis Hydroxyzine 10 mg prn for sleep,"I received the influenza vaccine from Medical Center in Sept. 2020. I received the tetanus vaccine October 26th, 2020. No other illnesses at the time of vaccine. I had complete check-up with labs, mammogram, and thyroid ultrasound by my previous primary care provider 10/26/20. She was transitioning to a new position and I established care with another PCP on 12/17/20 . I had repeat laboratory testing done at this time.",migraine headache endometriosis,,sulfa-anaphylaxis,"['Arthralgia', 'Blood glucose normal', 'Blood magnesium normal', 'Blood pressure increased', 'Chills', 'Computerised tomogram head normal', 'Electrocardiogram normal', 'Fall', 'Fatigue', 'Full blood count normal', 'Limb injury', 'Magnetic resonance imaging brain', 'Metabolic function test normal', 'Pain in extremity', 'Seizure like phenomena', 'X-ray limb normal']",1,MODERNA,IM 919276,MD,50.0,F,"Pain, Swelling and redness at injection site and extending over upper arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,PVT,"Estradiol/Norethindrone, Famotidine 40 mg daily, Allegra 180 mg daily, meformin 100 mf daily, rosuvastatin 5 mg daily, valsartan 80 mg daily, Vitamin D 50,000 units weekly","Type 2 diabetes, Mixed hyperlipidemia, obstructive sleep apnea, prehypertension",As above,,"cetirizine, cantaloupe, peach, environmental allergies","['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 919277,MI,65.0,F,Patient noticed in the am on 12/31 she had hives on her chest. The rash was not itchy. She states she applied topical hydrocortisone and took allegra. The rash faded and resolved within 24-48 hours. Patient states the rash did not spread. She states she commonly gets hives and they are usually associated with emotional stress. She reports that she was stressed prior to receiving the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,PVT,"Vit D3, Lexapro, levothyroxine,losartan, MVI, allegra, fluticasone, naproxen, timolol oph, latanoprost oph",none,"hypothyroid, hypertension, hyperlipidemia, glaucoma, cataract, prediabetes, depression",,"Bactrim, latex, macrobid","['Rash', 'Urticaria']",1,MODERNA,IM 919278,PA,,F,1/4 I woke up and the area grew larger but the redness is going away (fading inside out) and I have a big circle around my arm about the size of coffee mug. notified employee health and went to urgent care 1/4. ER stated that this is a reaction,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/01/2021,8.0,WRK,"mult vite, calcium chewable, stironolactone,",no,anemia,,no,"['Erythema', 'Injection site swelling', 'Reaction to preservatives', 'Urticaria']",1,MODERNA,SYR 919279,IA,43.0,F,Hives,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,Effexor Lisinopril,None,Hypertension Depression,,Neomycin Sulfa,['Urticaria'],1,PFIZER\BIONTECH,SYR 919280,MO,24.0,M,Extreme Tachycardia (HR 160-180s) for over 12 hours Uncontrolled cold shakes for over three hours Fever for 24 hours Fatigue for 3+ days Tiredness 3+ days Body aches 3+ days Uncontrolled migraine over 48hrs,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/28/2020,0.0,PVT,,,,,PCN,"['Fatigue', 'Migraine', 'Pain', 'Pyrexia', 'Tachycardia', 'Tremor']",1,MODERNA,IM 919281,MA,30.0,M,"On 12/24 I began to notice intermittent tingling along the medial edge of my left hand (in ulnar distribution). Over the next day or two I began to notice persistent weakness of the 4th and 5th digits on my left hand to abduction, adduction, flexion, and extension. Over the weekend the weakness improved slightly, but has not improved much in the past few days. I am also still occasionally experiencing the tingling sensation in the same distribution.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,WRK,,,,,None,"['Muscular weakness', 'Paraesthesia']",1,MODERNA,IM 919282,AZ,39.0,F,"12/29/20 ~1115 Received Pfizer COVID-19 vaccine. Only issue within the 15minute wait time is tenderness in injection site. No adverse effects until 2 pm (dizziness, headache, fatigue, nausea, chills). Got home by 5pm. Worsened symptoms. Temperature hit 40C. Myalgias and joint pain started. Took Tylenol 1gm. Recurrent fever and chills. Symptoms did not get better. 12/30/20 started having pressure and stabbing chest pain. Went to ED for dehydration and nausea. Negative chest xray and troponin. COVID PCR also negative. As of 1/4/2021, writer is still experiencing same symptoms to a lesser extent.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,Bystolic Telmisartan HCTZ Singulair Benadryl Sambucol Elderberry Vit B12 Albuterol,Fatigue,HTN Dermatitis Back pain Asthma Heartburn,,Morphine Hydroxyzine Shrimp Crab,"['Arthralgia', 'Chest X-ray normal', 'Chest discomfort', 'Chest pain', 'Chills', 'Dehydration', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative', 'Troponin normal']",1,PFIZER\BIONTECH,SYR 919283,NY,27.0,F,"Delayed Moderate. Myalgias several hours later, worsened myalgias in the Evening, Shivering, ""burning up"" no fever, headache, back pain, palpitations, left axillary lymph node (peach pit size) bilateral inguinal pain next day. Symptoms improved",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/16/2020,12/16/2020,0.0,PVT,,,,,,"['Back pain', 'Chills', 'Feeling hot', 'Groin pain', 'Headache', 'Lymphadenopathy', 'Myalgia', 'Palpitations']",1,PFIZER\BIONTECH,IM 919286,GA,55.0,F,"Received the shot 1710 on 12/21/20. Restless sleep. Awoke with body aches, took 1000mg Acetaminophen. Felt fine until 1500, started with fever/chills, temp 100.8. Went to sleep then, awoke at 1845 with oral temp at 103.4. Took 2nd dose 1000 mg Acetaminophen. Temp decreased to 102. 5 within 45 mins, dropped to 101 by 2030.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,HCTZ/Lisinopril Estrogen Patch Multi-Vit,,"HTN Was Covid + July 14, 2020",,,"['Chills', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 919287,WA,41.0,F,"Taste buds went numb, metallic taste, slight swelling of throat, itchiness all to upper body, joint pain, and pain at injection site. Lasting about 12 to 24hours. Antihistamines treated at home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"Metformin, Cymbalta, ibuprofen",None,"IBS, Depression",,"Penicillin, strawberry","['Arthralgia', 'Dysgeusia', 'Injection site pain', 'Pharyngeal swelling', 'Pruritus', 'Taste disorder']",1,PFIZER\BIONTECH,IM 919288,MD,31.0,F,"I had a burning sensation on vaccine site and all over my left arm, I also developed and rash later on the day I was given the vaccine. my left arm was sore for two days but there is an aching pain that I continued to have. there is also a spot higher up from the vaccine site and it looks like a ring around it. the rash remains and continues to itch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,UNK,"Zyrtec, Azithromycin",ear infection,,,penicillin,"['Burning sensation', 'Injection site discolouration', 'Injection site pain', 'Pain', 'Pain in extremity', 'Rash', 'Rash pruritic']",UNK,MODERNA,IM 919289,WI,32.0,F,"Injection site soreness, injection site red, hot and hard lump. Headache, fatigue, tiredness, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 919290,KY,40.0,F,"Got dizzy, broke out in sweat, nauseated, felt like an allergic reaction, itching all over.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,Synthroid 100mg,11/4 positive for COVID19,no,,"strawberries, seafood","['Dizziness', 'Hyperhidrosis', 'Nausea', 'Pruritus']",1,MODERNA,IM 919291,CO,43.0,M,"Localized reaction around vaccine site. Swelling, redness, itch. Lasted 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/29/2020,6.0,PVT,"Citalopram, 10 mg, taking every eight days as weaning off Magnesium Centrum Men's Health DMV Tumeric Glucosamine and Chondroitin Echinacea",None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Local reaction', 'Vaccination site swelling']",1,MODERNA,IM 919292,KY,17.0,M,I am reporting that the Moderna vaccination was given inadvertently before the minimum age 18 requirement.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PUB,none known,none known,none known,,none known,['Product administered to patient of inappropriate age'],1,MODERNA,IM 919293,NY,49.0,F,"Patient complained of dizziness 5 minutes post vaccination. Her BP was elevated at 150/99 mm/Hg, then after 10 minutes her BP decreased to 134/88 mm/Hg and after 15 minutes her BP was at baseline 126/85 mm/Hg. She stated she felt better and her dizziness resolved at this time",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,,,,,Mango flavoring agent,"['Blood pressure increased', 'Dizziness']",1,MODERNA,IM 919294,NY,61.0,M,"I felt light headed, sore arm, head ache and fever at first and that evening. Then woke up the next morning I felt fine but had swelling to the face more swelling to the left side then the right with a heavy feeling to my left side of my face along with pain to the eye. I feel very lethargic and very tired I could not go to work. I feel to bad to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,none,none,none,,none,"['Discomfort', 'Dizziness', 'Eye pain', 'Fatigue', 'Feeling abnormal', 'Headache', 'Impaired work ability', 'Lethargy', 'Pain in extremity', 'Pyrexia', 'Swelling face']",UNK,PFIZER\BIONTECH,IM 919295,WI,49.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919296,MO,36.0,F,"Employee here with COVID vaccination site reaction. Left arm below deltoid and to the posterior is red, swollen, warm to the touch, and itching. The area measures 6 X 5 cm. States noticed redness2 days after vaccination and worsened 12/29/30. No medications have been taken so far. Advised to try conservative measures first cool compress, OTC IBU and Benadryl. The site was outlined in pen. Advised if reaction worsens to be seen by PCP or urgent care.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/22/2020,1.0,PVT,,,,,,"['Erythema', 'Peripheral swelling', 'Pruritus', 'Skin warm']",1,MODERNA,IM 919298,WI,27.0,F,"Fever, Chills, body aches for 96 hours after receving vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Nuva ring, flonase, daily vitamin, and zyrtec",,,,,"['Chills', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 919299,OH,59.0,F,"Beginning 24 hours after my vaccine I had severe chills, severe body aches, headache, fatigue. These lasted 24 hours then resolved. Soreness and itching in left arm for several days, but not severe.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PUB,"Meloxicam, fluoxitine, zyrtec, trazadone, multivitramin, Vit D, calcium, fish oil",none Had covid beginning 6 weeks prior to vaccine,,"fatigue, fever, aches after 1st dose of shingles at age 57","Allergy to phenol, and indoor and outdoor environmental allergies","['Chills', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Pruritus']",1,MODERNA,IM 919300,PA,33.0,F,"Patient reported a small tender lump at the site of the injection and she stated this is similar to what she experiences with other vaccines. On December 30th, she reported that on 12/28 in the evening, she started feeling itchy at the site of the injection. On 12/29/2020, the area looked red and warm and had grow to the size of a ""clementine"". The patient took one dose of non-drowsy antihistamine and by the 30th the erythema improved. I spoke with the patient today, 1/4/2021, and all symptoms have resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/28/2020,7.0,PVT,Unknown,,,Small lump at the site of injection,"Patient states history of contact dermatitis, but no other known allergies.","['Injection site erythema', 'Injection site mass', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 919301,MI,26.0,F,"At 2:56pm, associate complained of nausea, lightheadness. Blood pressure was elevated; 165/102; heart rate 98bpm; SPO2 99% on room air; Placed in supine position in observation area. Administered Benedryl 50mg oral at 3:25pm; Blood pressure was rechecked at 3:40pm; 141/91; heart rate 88; associated states she felt improved of all symptoms; associate has been cleared to return home; husband will transport",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Blood pressure increased', 'Dizziness', 'Heart rate increased', 'Nausea']",UNK,PFIZER\BIONTECH,IM 919302,AZ,46.0,F,"got very anxious during the 15min waiting period after receiving first Moderna COVID19 vaccine... wanted to drink water, throat seemed itchy, was very shaky, tachycardic to 105, BP 139/60, RA sat 100%, clear lungs. Laid down and rested with improvement of symptoms. HR to 86, no longer shaky, no longer with itchy throat, RA sat remained 100%, BP decreased to 118/45. Able to sit up then walk with no dizziness/wooziness, felt totally back to normal after <30min and was discharged to home. No meds or ER visit.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,Sumatriptan 25mg prn,,Headache disorder Impaired glucose tolerance,,Bactrim - rash,"['Anxiety', 'Tachycardia', 'Throat irritation', 'Tremor']",1,MODERNA,IM 919303,TN,41.0,F,DIZZY AND FLUSHED. PT WAS ATTENED BY EMS. PT THEN STATED SHE FELT FINE. PT WAITED AN ADDITIONAL 15 MINUTES. PT WAITED A TOTAL OF 30 MINUTES. EMS SAID PT COULD LEAVE. PT LEFT IN STABLE CONDITION.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,unknown,unknown,unknown,,no known anaphylactic reaction to an injectable or intravenous vaccine or medication.,"['Dizziness', 'Flushing']",1,MODERNA,IM 919304,AL,28.0,M,"Developed fever, malaise, and cough about 12-16 hours after administration of the vaccine; symptoms were present for about 2-3 days. Of note, tested positive for COVID-19 at an urgent care clinic the day after vaccination (unaware of COVID-positive status prior to vaccination).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,Cetirizine 10 mg by mouth daily,COVID-19 (unaware at the time of vaccination),Asthma,,Nuts,"['COVID-19', 'Cough', 'Influenza A virus test negative', 'Influenza B virus test', 'Malaise', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 919305,NY,36.0,F,"Delayed Moderate. temp 100.6-100.1, , nausea,chills, elevated Heart rate 110 muscle ache, fatigue, weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,PVT,,,,,,"['Asthenia', 'Chills', 'Fatigue', 'Heart rate increased', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 919306,HI,52.0,F,Hives on left arm close the injection site. Hives and skin redness on upper chest between breasts,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Metformin, Multivitamins",Diabetes,,,Shellfish,"['Erythema', 'Injection site urticaria', 'Urticaria']",1,PFIZER\BIONTECH,IM 919308,MI,72.0,M,"Chills, arm ache, hives on right arm, and back on right shoulder. Ache back of neck, headache. Early Thursday on 12/31/2020 went to ER Treatment was, Prednisolone injection, Benadryl, Norco for pain. Follow up at home with Benadryl and Narco",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,PUB,Metformin; Atorvastatin; Glimepiride; Lisinopril; Diltiazem; Eliquis; pot Cl Micro; Furosemide.,None,"Diabetic, heart",,Know of none,"['Chills', 'Headache', 'Neck pain', 'Pain in extremity', 'Urticaria']",1,MODERNA,SYR 919309,WI,46.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919311,MA,24.0,F,"Employee stated she felt she was beginning to get chills, felt shaky and was complexion became flushed and blotchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,Albuterol inhaler as needed for asthma,,"Asthma, Kidney cysts",,penicillin,"['Chills', 'Flushing', 'Rash macular', 'Tremor']",1,MODERNA,IM 919312,,36.0,M,"01/02: dry cough, headache, bodyache, congestion. Today 01/04 has phelgm and cough. Staff was due to start work today at 3 pm. But not feeling right. Had COVID test last week - negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,01/02/2021,12.0,UNK,,,,,,"['Cough', 'Headache', 'Nasal congestion', 'Pain', 'Productive cough', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH, 919313,RI,57.0,F,"7-8 hours after the vaccine on (12/30/20) I started feeling tired and sluggish. Next day (12/31/20) at 9:30 am I started with body aches, chills and headache. I got a fever of 100.2 at 4:00 pm. I took 800mg of Ibuprofen at 4:00 pm and 9:30 pm and fever broke at 12:00 am. Next day (1/1/21) I still had a tiny headache and felt very tired. I didn't start feeling better until Saturday (1/2/21). On Sunday (1/3/21) I felt better and was able to go outside for some fresh air.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,Synthroid,Hypothyroidism,None,,Sulfa,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia', 'Sluggishness']",1,PFIZER\BIONTECH,IM 919314,IN,22.0,F,swelling of tongue and lips 25 minutes after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Acutane and birth control pills,none,none,,none,"['Lip swelling', 'Swollen tongue']",1,MODERNA,IM 919315,PA,40.0,F,"Patient immediate burning in her shoulder. Puncture site found to be too high for deltoid. Contacted Pfizer and IM/ID physician. Will re vaccinate in 5 days. Arm very painful, lump under acromion process. Feels like bursitis.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Bursitis', 'Immediate post-injection reaction', 'Injection site mass', 'Injection site pain', 'Pain in extremity', 'Product administered at inappropriate site']",1,PFIZER\BIONTECH,IM 919317,TX,48.0,M,"Fever, Malaise, Joint pains and Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,Losartan/HCTZ and Norvasc,,,,nkda,"['Arthralgia', 'Chills', 'Malaise', 'Pyrexia']",1,MODERNA,IM 919318,TN,50.0,F,"During pt 15 minute wait after receiving vaccine, pt felt dizzy and light headed. Pt stayed an additional 15 minutes for a total of 30 minutes and was attended by the RN. Pt stated she was feeling better. RN said pt was fine to leave. pt left in stable condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,unknown,unknown,unknown,,no known anaphylactic reactions to vaccines or intravenous medications.,['Dizziness'],1,MODERNA,IM 919319,TX,36.0,F,"Hives to opposite arm starting the same day of vaccine, hives continuing to spread over arms, back, and buttocks 2 weeks from injection date. Currently controlled with benedryl",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,PVT,None,None,Obesity,,"Sulfa, Clindamycin, Orthotricyclen",['Urticaria'],1,PFIZER\BIONTECH,IM 919320,TX,40.0,F,"Right arm swelling very bad right after shot, next day woke up to get ready to work I started to get light headed, dizzy, sweating, felt like I was going to pass out. My husband then called 911. They took me to Hospital ,I stayed there for a couple hours then released. They told me to stay home and the next day I felt fine. I did a televisit with my Nephrologist (Kidney doctor) the following week.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/22/2020,12/22/2020,0.0,WRK,Toperol (high blood pressure) Adderall - 20mg Calcitrol- .5mcg Soduim bycar-650mg,Stage 5 Kidney failure,Stage 5 Kidney failure,,Mushrooms Bactriun,"['Blood test', 'Dizziness', 'Hyperhidrosis', 'Immediate post-injection reaction', 'Peripheral swelling', 'SARS-CoV-2 test']",1,MODERNA,IM 919321,NY,54.0,F,"Chills, low grade fever, severe body aches, head aches, (for 2 days) injection site hematoma",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,Losartan HCTZ Symvastatin,None,None,,None,"['Chills', 'Headache', 'Injection site haematoma', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 919322,,33.0,F,"Elevated heart rate in 110-130s approximately 12 minutes after injection given. Pt states feeling ?jittery and racing heart..?Denies shortness of breath, chest pain/tightness. Denies any tingling in throat. SpO2 99% on room air. Bp 120/72. No other symptoms. During period of monitoring heart rate decreases to 80s for few minutes then elevated to >110s. After 30 minutes pt returns home. For next 4 hours following occasional periods of elevated heart rate 110-130s. Only 3 episodes the next day. Mild headache during this day but no other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PUB,None,None,None,,Nka,"['Feeling jittery', 'Headache', 'Heart rate increased', 'Palpitations']",1,MODERNA,IM 919323,PA,34.0,F,Hot and lightheaded,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Dizziness', 'Feeling hot']",1,PFIZER\BIONTECH,IM 919324,TX,32.0,F,"Body aches, chills, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,Unknown,COVID positive in October 2020,,,Unknown,"['Chills', 'Pain', 'Pyrexia']",1,MODERNA,IM 919325,CA,48.0,F,"I received my shot at appx 1300 hours. By 1700 hours I had a flare up of Vasculitis symptoms. I began to get little red dots on both of my lower legs a total of about 10. They began really light and over the night got brighter and bigger. I went to the doctor the next morning and was given a prescription for a steroid and antibiotic which I first took at 2000 hours on 12/31/2020. By the next evening my dots began to get lighter. As of today all but one have faded away. The one I have is really light. I did have some of the usually listed symptoms, slight headache, runny nose, hard to breathe.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,WRK,"Multi-Vitamin, Hair, Skin & Nail vitamin, Vitamin Zinc, Vitamin B complex, Nasal Spray Flonase",Sinus headache,Vasculitis,,"Ibuprofen, Cipro, bananas","['Dyspnoea', 'Headache', 'Rhinorrhoea', 'Vasculitis']",1,MODERNA,SYR 919326,PA,39.0,F,"DEVELOPED FLAT, RED RASH OVER NECK AND UPPER TORSO. BENADRYL 25MG ADMINISTERED IM AND RASH RESOLVED WITHIN A HALF HOUR",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"NADOLOL, FLORINEF, MIDORINE, OMEPRAZOLE, PROBIOTIC, VIT D",POTS,,,"BACTRIM, KEFLEX","['Rash', 'Rash erythematous']",1,MODERNA,IM 919327,MT,38.0,F,"40 mins after receiving the vaccine the right side of my throat, ear, forehead and arm went numb. The right site of my body started tingling. Burning , red, swollen and itching at the injecting site.. Area around injection site was the size of a softball very painful, itchy, burning sensation, swollen, and red. I took Benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,None,None,Bronchitis,,chloraScrub adhesive bandages Doxycycline Methocarbamol,"['Hypoaesthesia', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Paraesthesia', 'Pharyngeal hypoaesthesia']",1,PFIZER\BIONTECH,IM 919328,CA,41.0,M,Fever chills headaches fatigue muscle ache,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,UNK,,,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 919329,DE,92.0,F,"Facial drooping occurred on 1/3/2021, patient sent to ER and returned with diagnosis of Bels Palsy on 1/4/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,SEN,Levothyroxine Citalopram Metoprolol Diltiazem Loratadine Tylenol Arthritis Colace Famotidine,None,Atrial Fibrillation COPD Epilepsy Depression Hypertension Vascular Dementia Arthritis TIA's GERD,,"Morphine, Oxycodone, Penicillin, Sulfa Antibiotics",['Facial paralysis'],UNK,PFIZER\BIONTECH,IM 919331,NC,54.0,F,Patient described ringing in the ears and had an apparent rash on both arms with swelling in the administration arm. Symptoms appeared 10 minutes after vaccination. We administered 50 mg Diphenhydramine and about 15 minutes after patient stated that symptoms were resolving.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,SEN,unknown,none lister,none listed,,,"['Peripheral swelling', 'Rash', 'Tinnitus']",UNK,MODERNA,IM 919332,TX,37.0,F,"Pt reports pruritic circular rash to area just below injection site 9 days following shot. Areas subsequently erupted on bilaterral digits of both hands, and toes of both feet. Vesicles are noted on initial eruption. Pt has used trimacinalone cream 1% with temporary relief. Evaluation by MD here at clinic resulted in additional antifungal cream. Pt denies any other symptoms at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/30/2020,9.0,WRK,Labetalol 300 mg levothyroxine 50 mcg,None noted,None noted,,NKDA,"['Injection site reaction', 'Rash', 'Rash pruritic', 'Rash vesicular']",1,MODERNA,IM 919333,AZ,41.0,M,"After receiving 1st Moderna COVID19 vaccine and while waiting during the 15min waiting period, patient saw someone else get anxious and wobbly and need to lay down, then he also got anxious and felt like his vertigo had been triggered... dizzy when turning head to the side, which he gets sometimes, but this started for him after vaccination. Laid down, rested, and felt better-- symptoms resolved and he was discharged to home. Noted to be hypertensive 143/93-- discussed with him and asked him to speak with primary care physician.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"loratadine, fluticasone",,Mild intermittent asthma Duodenal ulcer disease Bilateral keratitis sicca,,NKDA,"['Anxiety', 'Dizziness', 'Hypertension']",1,MODERNA,IM 919334,NY,30.0,M,Acute pericarditis,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/01/2021,4.0,PVT,"Truvada, Lexapro, Wellbutrin",,prior COVID-19 infection in March 2020,,Cefprozil,"['Echocardiogram normal', 'Electrocardiogram normal', 'Full blood count normal', 'Metabolic function test normal', 'Pericarditis', 'Troponin normal']",1,PFIZER\BIONTECH,IM 919336,CO,56.0,F,"On 1/3, experienced redness, ""blotchy chest,"" ""red dots to skin,"" ""hives on both palms."" Feet itching, but ""I didn't investigate that."" Took Benadryl 25mg x 2 tablets on 1/3 morning. Resolved on 1/3 in the evening.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/03/2021,4.0,WRK,Levothyroxine. ProAir prn,Bronchitis in November,"Hypothyroidism and asthma, bronchitis",,"Sulfa - hives Bees - redness Tramadol - hives and ""redness all over""","['Erythema', 'Pruritus', 'Rash macular', 'Urticaria']",1,MODERNA,IM 919337,KY,35.0,F,"I am an APRN, and received the vaccine not quite one week ago. I waited 15 minutes within the facility and then left. Sat in my car working for about 8-10 minutes when a sudden rush of heat ran through my body. I felt lightheaded, my tongue was prickly, and I felt like I was going to pass out. I was able to get back into the facility to let them know of the sudden symptoms. At that time I felt like my heart was racing and was diaphoretic. They continued to watch me for another 15-20 minutes, they did have an epi pen but it was not given. I was feeling slightly better and then left again. I waited in my car approximately 20 minutes before deciding it would be safe to drive away. After driving for about 10 minutes I had another rush of heat, lightheadedness, and then I started having shortness of breath. At this time it would have been about 1 hour, maybe longer, since receiving the vaccine. I was not close to an emergency medical facility at that time, and did not feel like my throat was swelling so thought it would be best to try to drive to the nearest ER. I knew I had an epi pen from my work that I could use if needed. I contacted another nurse practitioner who I work with who stayed on the phone with me until I was able to get to a safe place. At that time the symptoms had improved, not resolved. It had been able 20 minutes during this episode. In all, I continued to feel jittery for about 3-4 more hours. Since my symptoms did improve I did not go to the ER. I contacted my health department, Louisville health dept, the following day and reported symptoms to the medical director.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,"vitamin d, humira, folic acid, propranolol (as needed).",none,crohn's disease,,nkda,"['Dizziness', 'Dyspnoea', 'Feeling jittery', 'Hot flush', 'Hyperhidrosis', 'Palpitations', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 919339,ND,66.0,F,"The injection was given too high and infiltrated the bursa sack around the shoulder joint. The left shoulder became very painful on the evening of 12/31/2020. The patient placed heating pad on the joint intermittently, exercised her arm and took ibuprofen for 48 hours. It was resolved in 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,Unknown,None,Rheumatoid Arthritis,,Sulfa drugs,"['Arthralgia', 'Wrong technique in product usage process']",7+,MODERNA,IM 919340,TN,50.0,M,"During the 15 minute wait after receiving vaccine, pt stated his lips and tongue felt tingly. Pt was attended to by EMS. Pt stayed an additional 15 minutes for a total of 30 minutes. Pt stated he felt fine. EMS said pt could leave. pt left in stable condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,unknown,unknown,unknown,,no known anaphylactic reaction to vaccines or intravenous medications.,['Paraesthesia oral'],1,MODERNA,IM 919341,WA,37.0,F,"~24 hours after injection, patient experienced mild fatigue, low appetite, sinus symptoms (feeling blockage in right side sinuses), exacerbation of tinnitus in R ear. Symptoms persisted 48 hours after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,WRK,"zolpidem 5 mg, st. johns wort, tylenol",otitis media 3 weeks prior to vaccination,,,onion GI intolerance,"['Decreased appetite', 'Fatigue', 'Sinus congestion', 'Tinnitus']",1,MODERNA,IM 919342,CA,66.0,F,"Immediately: Achy Sore Itchy Hot to touch Day 2 and Day 7: Flu like symptoms Day 5: Symptoms were worse: Redness, hard, and extremely itchy Day 7: redness measured 5.08cm Day 9 (today): Redness measures 11.5cm x 9cm and still growing Still itchy, not as sore but still warm to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/26/2020,0.0,UNK,,,,,,"['Influenza like illness', 'Pain', 'Pruritus', 'Skin hyperpigmentation', 'Skin warm']",1,MODERNA,SYR 919343,WI,31.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919344,PA,28.0,F,"within 10 minutes patient became pale and lightheaded, heart rate elevated, continued to have flushed feeling. Rapid response called observed, provided water and ice. Felt dizzy when tried to walk. Observed for 45-60 mins.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Dizziness', 'Flushing', 'Heart rate increased', 'Pallor']",1,PFIZER\BIONTECH,IM 919345,TX,22.0,F,"redness, warmth, induration at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,unknown,unknown,unknown,,unknown,"['Injection site erythema', 'Injection site induration', 'Injection site warmth']",1,MODERNA,IM 919346,MN,28.0,F,"She received the vaccine on 12/30/2020 at approximately 4:35 PM. At 7 PM she experienced immediate exhaustion, very hot, and body aches. Her temp when she got home was 102.7. She experienced an all over rash and her temp fluctuated for 65 hours. She went to Urgent Care both on Saturday and Sunday due to the ?burning? of the rash. She received Steroid treatment both days. She is back to work today, however, continues to have burning rash. She was advised by the Urgent Care provider not to receive the second injection, and not to ever receive vaccines with the mRNA component.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,Unknown,Unknown,Unknown,,Unknown,"['Burning sensation', 'Fatigue', 'Feeling hot', 'Pain', 'Pyrexia', 'Rash']",1,PFIZER\BIONTECH,IM 919347,AZ,32.0,M,"During his 15min waiting period after receiving the Moderna COVID19 vaccine, patient got somewhat anxious... tachycardic, htn, wobbly knees, felt unwell. Didn't want any intervention, but agreed to lay down. While resting, BP down to 135/65, HR to 89, looked better and calm but then after 10-15min complained that his throat felt itchy. Then said he was allergic to peanuts, but only when eaten in lg quantities. No signs of anaphylaxis, but was sent to ER for evaluation and obs. Left ER w/o getting seen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,PVT,None that are obtained from our facility,,None listed in our electronic health record,,None,"['Anxiety', 'Hypertension', 'Joint instability', 'Malaise', 'Tachycardia', 'Throat irritation']",1,MODERNA,IM 919348,GA,41.0,M,"Itching, redness at injection site approximately 1 week post-vaccination. Triangular, red, raised area, approximately 4x4cm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PVT,multivitamin atorvastatin levetiracetam,none,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 919349,AL,37.0,F,"Flushed cheeks, tingling to lips",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Flushing', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 919350,NY,41.0,F,"First Headache at approx 10:00pm then later that night at approx 02:00 am left armpit pain, left upper chest pain, left humerus pain, left elbow pain, left wrist pain, left radius and ulna pain, fatigue, lethargy, insomnia, fever 99.9 was highest taken with 2 extra strength Tylenol taken, chills, excessive sweating, decreased appetite until evening of the next day. arm pain decreased but arm pit remains swollen and painful for 2 days so far. Headache gone after 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Fish oil, vit c pill",None,None,,Allergy to shell fish-clams and oysters,"['Arthralgia', 'Axillary pain', 'Chest pain', 'Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Insomnia', 'Lethargy', 'Oedema peripheral', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 919351,TX,47.0,M,NUMBNESS TO BOTH ARMS AND LEGS,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,NONE,NONE,NONE,,KEFLEX,['Hypoaesthesia'],1,PFIZER\BIONTECH,IM 919352,OK,24.0,M,"Hives mainly on torso, spread down to legs. Zytec 10 mg was taken. Symptoms have yet to resolve",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Lisinopril 10 mg daily Bupropion HCL 150 mg XL,,Hypertension,,Iodine,['Urticaria'],1,PFIZER\BIONTECH,IM 919353,ND,28.0,F,"Patient reported to me that she developed a rash to her extremities the evening of vaccination. She proceeded to take benadryl. Patient reported taking benadryl repeatedly Tuesday, Wednesday, Thursday, Friday and by Saturday morning she had to go to the ER to get some steroids. Patient stated that it was a hive reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,SEN,"Benedryl, Predisone, Fomotidine",None,None,,"Penicillins, Vancomycin, Azithromycin, Sulfamethoxazole with Trimethoprim, Nitrofurantoin, Penicillin G","['Rash', 'Urticaria']",UNK,PFIZER\BIONTECH,IM 919354,KS,39.0,M,"Left upper trapezia silver dollar sized area with raised bumps. Slightly painful, itchy. Went undiagnosed but mimicked shingles. Has slowly gotten better. Still very visible, 90% cleared. Emailed PCP, was not seen in office.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/20/2020,1.0,WRK,No,Rash,No,,No,"['Rash', 'Rash papular', 'Rash pruritic']",UNK,PFIZER\BIONTECH, 919356,NV,58.0,F,"At 11:19 am the recipient stated she felt a warm sensation on her mouth and tingling of the lips. VS: BP=141/90, HR= 94, O2 Sat=96% RA, Temp= 37 Celsius. VS at 11:28 am: BP=141/90, HR= 94, O2 Sat=95% RA, Temp= 37 Celsius. at 11:30 participant stated the tingling of the lips had gone away, but the warm sensation on her mouth continued. At 12:20 the participant stated she still had the warm sensation on her mouth but the tingling was absent. 12:30 pm the participant felt comfortable leaving and left the facility.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,Unknown,Unknown,Unknown,,None,"['Blood pressure increased', 'Feeling hot', 'Heart rate increased', 'Paraesthesia oral']",1,MODERNA,IM 919357,WI,31.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919358,,25.0,F,Indurated and itchy urticaria around site of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,,,,,,"['Injection site induration', 'Injection site pruritus', 'Injection site urticaria']",1,MODERNA,IM 919359,MA,57.0,F,Itchy throat 6 minutes after vaccine administration - evaluated by EMS - drank water - symptoms resolved by 5:25pm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,,,,,,['Throat irritation'],1,MODERNA,IM 919360,VA,40.0,F,"Received vaccine on 12/30/20 approx. 5pm. On morning of 12/31/20 experiencing fatigue, chills, aches, fever, loss of appetite and diarrhea. As of 1/4/21 continues to have diarrhea and loss of appetite. Going to see provider today as she found out that a church member tested positive for covid. planning to be tested today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,"Paxil, Claritin, Multivitamin",No,None,,"PCN, Lexapro, seasonal allergies","['Chills', 'Decreased appetite', 'Diarrhoea', 'Fatigue', 'Pain', 'Pyrexia']",1,MODERNA,IM 919361,TN,62.0,F,"Patient complained of left lower lobe of lung pain, which she stated has been causing her symptoms prior to Moderna vaccine administration. Asked patient if she needed treatment and she stated no and she just wanted to let us know.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,SEN,Unknown,Patient reported vasomotor and left lower lobe respiratory as well as asthma as chronic conditions,"asthma, vasomotor symptoms and left lower lobe respiratory issues that are long standing",,"Pt reports foods, medications and latex that cause anaphylaxis, none contraindicated with Moderna vaccine.",['Pulmonary pain'],1,MODERNA,IM 919362,NE,31.0,F,"Swollen, painful lymph nodes in right armpit",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/04/2021,6.0,OTH,Ibuprofen,None,Medullary Sponge Kidneys,,"Augmentin, Ceclor","['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 919365,NE,65.0,F,"Pt. calls into work on 12/28/2020 crying and reports that she is not able to move or turn in bed without having sever discomfort in her neck; therefore unable to work her scheduled shift. Pt. reports with movement of her arms esp. her left arm that she gets ""shooting pain"" with radiation to the nap of her neck. Pt. denies any fevers at this time. Pt. reports that she had medicated with Tylenol Arthritis without relief. Pt. reports noticing muscle aches and discomfort on 12/26 but on 12/28/2020 is severe in nature. Pt. made an appointment with her PCP on 12/28/2020 at 1400. Pt. was instructed to take Ibuprofen 200 mg tid for a total of 600 mg as needed, cont. to use ice at home and was given Diazepam as a muscle relaxant. On 12/29/20 pt. was able to return to work and reported feeling better. Pt. returned to the clinic on 12/30/2020 again with severe discomfort in the shoulders, neck and upper body. Pt. was seen by PA-C and was administered a shot of Toradil IM, placed on Prednisone 40 mg for 5 days, lab was obtained and was instructed to cont. with the ice and Ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/26/2020,3.0,PVT,"Prenatal vitamin 1 tab daily, Tylenol Arthritis 650 mg 1 tab bid, Letrozole 2.5 mg daily, Amitriptyline HCL 25 mg q hs, Lisinopril-HCTZ 20-12.5 mg daily, Miralax 17 gm as needed daily, Ventolin HFA 108 (90 base) MCG/ACT 1-2 puffs q 4-6 ho",Denies,"Pt. reports having a hx. of undiagnosed arthritis. Reports having a deteriorating disc between shoulder blades, has reactive cervical lymphadenopathy, HTN, had invasive ductal carcinoma of left breast in 2018. Received chemo and then had bil. mastectomy and total hysterectomy 12/2018.",,"NKA to foods, medications or other products.","['Crying', 'Discomfort', 'Impaired work ability', 'Laboratory test', 'Mobility decreased', 'Muscle discomfort', 'Musculoskeletal discomfort', 'Myalgia', 'Neck pain', 'Pain', 'Pain in extremity']",1,MODERNA,IM 919366,OH,54.0,F,"Started a few hours later with Diarrhea. Then next morning just a slight sore arm (typical of flu vaccines) but then the unbelievable fatigue and muscle soreness took over and restless night sleep. When to ED and had PCR done to make sure I didn't have Covid - it was negative. Cough came and went, mostly at night. I'm 3 days in and just now getting back to normal but the muscle pain and fatigue are still there. No fever. No headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,SCH,None,None,None,,Danocrin - hormone inj for endrometriosis.,"['Diarrhoea', 'Fatigue', 'Myalgia', 'Pain in extremity', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 919367,FL,36.0,F,"Developed delayed skin reaction week after injection slightly distal to site of injection redness, swelling, warmth > 10 cm worsened for a few days before improving",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,OTH,None,None,None,,Naproxen,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 919368,MD,32.0,F,"I got the vaccine at my workplace at 1115am. I had a normal day, no signs other than a sore arm a few hours later. I went to bed at 9pm feeling fine, and woke up at 10pm very Sick, Throwing up & a fever of 100.8 , Body aches and a Bad headache. i tossed and turned for several hours feeling worse and worse. Eventually at like 9am the next day my heart rate started racing in the 140s. I went to the ER and was told they think the shot just ""Woke up"" My post covid tachycardia. I had COVID in july and a month later i started getting random bouts of tachycardia. They had subsided mostly, since late october. They did draw my blood and my Potassium was a little low,3.5. so he sent me home with a 7 day supplement of it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,lisinopril 10mg lexopro 10mg ortho-micronor OTC multivitamin,none,chronic bronchitis,,none,"['Blood potassium decreased', 'Electrocardiogram', 'Headache', 'Malaise', 'Pain', 'Pain in extremity', 'Palpitations', 'Pyrexia', 'Sleep disorder', 'Tachycardia', 'Vomiting']",1,MODERNA,IM 919369,WI,24.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919370,TX,28.0,F,"Saturday midnight stared with a headache, Sunday morning woke up around 9:30 to get milk for my 2 year old boy, wanted to take a Tylenol for the headache when I stared to feel really nauseous and fainted. I remember waking up laying down on the floor, I screamed at my husband I couldn?t get up. And my husband got me up from the floor when I fainted again in his Arms. He states I was unconscious for 10-15 seconds. After I wake up my headache and nauseous went always. I was fine the whole day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,PVT,,,,,,"['Headache', 'Loss of consciousness', 'Mobility decreased', 'Nausea', 'Screaming', 'Syncope']",1,MODERNA,IM 919371,NJ,43.0,F,"Burning to left arm, tingling to neck arms and legs. Elevated blood pressure.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,WRK,Vitamin D Multi vitamin Vitamin C,None,Sciatica,,Penicillin,"['Blood pressure increased', 'Paraesthesia']",1,MODERNA,IM 919372,PA,28.0,F,"Bell's Palsy on the right side of my face. ear ache, head ache all on the right side. droopiness of the right eye and right side of lips. inability to fully shut my eye., difficulty eating and drinking. Attempted to go to an urgent care on 1/02/2021, but they sent me to the ER. ER evaluated me and sent me home with antivirals and steroids. I was sent home with Prednisone and Acyclovir",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/31/2020,9.0,PVT,adderall xr meloxicam baclofen pristiq,,migraines and asthma,,shellfish All nuts except almonds sulfa drugs lexapro penicillin amoxicillin,"['Blood test', 'Computerised tomogram', 'Ear pain', 'Eating disorder', 'Eyelid function disorder', 'Facial paralysis', 'Headache']",UNK,MODERNA,SYR 919373,MN,39.0,F,"noticed twitching in L arm shortly after receiving vaccine, numbness , weakness and pain in arm and shoulder girdle, diagnosed with parsonage turner syndrome by neurologist, currently taking neurontin for pain as steroids not tolerated",Not Reported,,Not Reported,Not Reported,,Yes,N,12/30/2020,12/30/2020,0.0,WRK,,,endometriosis chronic,,no,"['Arthralgia', 'Hypoaesthesia', 'Muscle twitching', 'Muscular weakness', 'Neuralgic amyotrophy', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 919374,TX,59.0,F,"After several hours in pm. pt started vomiting uncontrollably, per pt states she threw up about 40 times. On sat morning pt, started having severe leg pain and couldn't stand to touch them. Informed pt to go to the ER to be seen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,"per pt states she reacted to Pneumovax, unsure response.",NKDA,"['Pain in extremity', 'Vomiting']",1,MODERNA,IM 919375,CA,57.0,M,Sore arm five minutes after injection Swollen aches GI No Appetite Not feeling well,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,UNK,,,,,,"['Decreased appetite', 'Malaise', 'Pain', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,SYR 919376,MT,19.0,F,"Patient received Moderna vaccine, Wednesday 12/30. On Saturday 1/3/2021 patient felt pressure/tightness in lower extremity. When patient touched area, a noticeable ball was felt under the skin, tender to the touch and warm. Patient went into urgent care on Monday 1/4/2021 with a confirmed dx of a superficial blood clot. Unknown etiology of whether this is from current birth control or the COVID19 Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/02/2021,3.0,PVT,"Dasetta 1/35, Bile salts OTC, Proair Inhaler PRN",N/a,Asthma,,Penicillin,"['Limb discomfort', 'Limb mass', 'Pain of skin', 'Skin warm', 'Thrombosis', 'Ultrasound scan abnormal']",1,MODERNA,IM 919377,VA,49.0,M,I had 5 minutes of blurred vision,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,OTH,finasteride 1 MG tablet rosuvastatin 20 MG tablet lisinopril 10 MG tablet,,,,IV Contrast,['Vision blurred'],1,MODERNA,IM 919378,WI,30.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,"gabapentin, seasonal","['No adverse event', 'Product storage error']",1,MODERNA,IM 919380,GA,27.0,F,I experienced hives to my abdomen and back.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/25/2020,4.0,WRK,None,None,None,,None,['Urticaria'],1,PFIZER\BIONTECH,IM 919381,TX,23.0,F,"Redness, induration, swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Erythema', 'Induration', 'Swelling']",1,MODERNA,IM 919382,MA,34.0,F,Severe sharp throbbing pain at injection site upon administration and continuing throughout observation period - site benign - still in pain at time of leaving facility.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,,,,,,"['Injection site pain', 'Pain']",1,MODERNA,IM 919383,OR,49.0,F,"Patient started to experience numbness in immediate area of injection site. She reports that approx 5 minutes after injection, numbness began to spread out from injection site, but was contained mostly to upper arm. She denies weakness, pain, numbness of mouth, difficulty breathing. BP 152/100. Pt reports she is very anxious. pt given ice pack and asked to stay in obs area for an extra 30 minutes. No sequelae after initial numbness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Anxiety', 'Injection site hypoaesthesia']",1,MODERNA,IM 919384,CT,60.0,F,"8 days post vaccination, patient reports itching with redness, heat and induration at the site of vaccination. Felt like a ""bee sting."" Resolved without treatment by 1/2/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,PUB,"fish oil, vitamin D ,magnesium",none,"HTN, high cholesterol",,sulfa,"['Injection site erythema', 'Injection site pruritus', 'Vaccination site induration', 'Vaccination site warmth']",1,MODERNA,IM 919385,MD,51.0,F,"On Dec. 24th I started to develop pain with breathing. No other symptoms. I was unable to take deep breaths and felt SOB because of that. I was evaluated in the emergency room on Mon 28th. Full workup completed, cardiac and PE. Work up negative and Covid test negative. I was diagnosed with pleurisy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/24/2020,7.0,WRK,"Amlodipine, Protonix, Prilosec, Zoloft, Wellbutrin, multivitamin, Amberen, magnesium, zinc, CoQ10, grape seed extract, Turmeric",None,"HTN, Depression",,Codeine- itching (sensitivity not allergy),"['Angiogram', 'Angiogram pulmonary normal', 'Chest X-ray normal', 'Dyspnoea', 'Electrocardiogram normal', 'Laboratory test normal', 'Painful respiration', 'Pleurisy', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 919386,TX,40.0,F,"Severe swelling of arm, redness, induration, warmth at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site warmth', 'Peripheral swelling']",1,MODERNA,IM 919387,TX,24.0,F,"Slight redness to lower forearm, sore throat, feverish, fatigue, ear pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,MIL,"Trintellix, Rexulti, Trazodone, Hydroxyzine, Yasmin",None,None,,None,"['Ear pain', 'Erythema', 'Fatigue', 'Oropharyngeal pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 919388,WI,54.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919389,IL,39.0,F,"Left side of throat, left soft palette, left side of mouth, left side of tongue, left side of jaw, left side of nose all felt numb, lymph node by left ear was swollen, left eye pressure, drooling Treated in Emergency Room, no monitor, no IV fluids, discharged with information on paresthesia, stomatitis",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/02/2021,4.0,PVT,phenerteren,None,None,,NKA,"['Drooling', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Laboratory test', 'Lymphadenopathy', 'Ocular discomfort', 'Paraesthesia', 'Pharyngeal hypoaesthesia', 'Stomatitis']",UNK,MODERNA,IM 919390,CA,58.0,F,"Face rash, itchy for 2 days, (face and neck) Face warm to touch, Seen by NP no treatment",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,Amlodipine 5mg; Losartan 50mg,None,Hypertension,,Niacin,"['Rash', 'Rash pruritic', 'Skin warm']",1,PFIZER\BIONTECH,IM 919391,NV,51.0,F,"At 8:40 am participant complained of dizziness. VS at 08:50 am; BP= 166/113, O2 Sats= 97% RA, HR= 78, RR= 18. Patient stated she did not have breakfast and perhaps she was hypoglycemic, thus she consumed a bottle of orange juice. VS at 08:56 am; BP= 195/106, O2 Sats= 98% RA, HR= 76. At 09:14 am, participates stated she is feeling better. VS at 09:20; BP=176/99, O2 Sats= 100% RA, HR= 79. At 09:42 am participant stated she continues to feel better; BP= 186/94, HR= 82. At 0945 am participant left the site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,Essential oils,None,None,,Unknown anti-depression pill,['Dizziness'],1,MODERNA,IM 919392,WI,54.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919393,PA,28.0,F,"Hot flash and dizzy next thing she knew she was in a stretcher. Gave her an ice pack and elevated feet. Went to ED, per patient did not receive any medications, just had an EKG.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,Covid + 12/13/20,,"meningitis, hives and received epi pen","Latex, Aspirin, dilaudid, percocet","['Dizziness', 'Electrocardiogram', 'Hot flush']",UNK,PFIZER\BIONTECH,IM 919395,IN,33.0,F,"High fever, headache, tenderness at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/21/2020,1.0,WRK,Tylenol as need Vitamin c 500mg twice a day Vitamin d 4000 IU once a day 100mg zinc once a day Augmentin twice a day for 10 days,,PCOS,,,"['Headache', 'Injection site pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 919396,KS,57.0,F,"Took covid shot Thursday 12/17. On Friday 12/18 had avastin shot to right eye. That afternoon had EXTREME inflammation, irritation, tearing, pain and light sensitivity. Vision became ""whited out"". Saw Dr. sunday 12/20, received two antibiotic shot and steroid shot all to right eye. Prescribed Levaquin po and antibiotic and steroid eye drops. Followed up with retinologist again today 1/4/21, symptoms fairly resolved but vision is still blurry. Hoping to completely regain my sight.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,"Lisinopril, simvastatin, zyrtec. Had an avastin shot in my right eye 12/18/2020",,"Diabetes, diabetic retinopathy and macular edema do",,"Penicillin, cephalosporin","['Bacterial test', 'Eye inflammation', 'Eye irritation', 'Eye pain', 'Lacrimation increased', 'Photophobia', 'Vision blurred', 'Visual impairment']",1,PFIZER\BIONTECH,SYR 919397,MA,53.0,F,"Employee told nurse she felt lightheaded and ""shaky"". Given water and asked to stay extra 15 minutes. Seen by EMT's for blood pressure check: 130/80, Pulse 77, 100%.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,Albuterol inhaler Possibly others which patient declined to disclose,,"Asthma, Raynaud's, Possible other diagnosis which patient chose not to disclose",,"Sulfa, Percocet","['Dizziness', 'Tremor']",1,MODERNA,IM 919398,TX,59.0,F,"extreme pain in arm with injection site, inability to move arm, insomnia due to pain in arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Injection site pain', 'Insomnia', 'Mobility decreased']",1,MODERNA,IM 919399,,44.0,F,"Employee received MODERNA vaccine on 12/28/2020 and had no symptoms on first day, then on 12/29/2020-2nd day employee experienced body aches, fatigue, nausea, and low grade fever-99.4, with no chills. Then on 12/30/2020-3rd day employee had body aches, and mild nausea only, by the 4th day employee feeling much better with no further symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,,,,,,"['Fatigue', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 919400,MS,54.0,F,localized itching at injection site. Benadryl 50mg capsules given. itching decreased- got better.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,unknown,None,,,morphine and related,"['Injection site pruritus', 'Pruritus']",1,MODERNA,IM 919401,AZ,48.0,F,"employee getting Pfizer COVID19 vaccination. about 10 min post injection developed feeling of flushing and ?""prickliness"" on skin. no resp distress no swelling or rash seen. VS taken and hypertension noted 170s/90s. normal O2sat and HR- NO prior medical hx of hypertension. Monitored for 30 min in vaccination clinic persistent hypertension. Referred to ED for ongoing monitoring-still hypertensive but eval neg referred to primary care provider for follow up",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/19/2020,0.0,PVT,None obtained from this facility,,None documented in this facility's health record,,ciprofloxacin - rash fexofenadine - unknown reaction,"['Electrocardiogram QT prolonged', 'Electrocardiogram ST segment abnormal', 'Flushing', 'Hypertension', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 919402,,40.0,F,local- soreness systemic/local-urticaria,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,PUB,Levothyroxine 50 mcg,none,hypothyroidism,,none,"['Pain', 'Urticaria']",1,PFIZER\BIONTECH,IM 919403,ME,23.0,M,"I received the vaccine through my employer. 7 Days after the vaccination event, my left deltoid muscle became significantly swollen, stiff and tender. There was pain when I tried to elevate the arm laterally. The site was very warm to the touch. I experienced periods of malaise and fatigue at random intervals throughout the week after which I received the vaccine. On day 8, a red rash began to appear on the vaccination site. It was slightly itchy. The area was still stiff and swollen, and painful to move past a certain angle. This night I felt especially fatigued. On day 9 I woke up to see the swelling was mostly subsided, however the rash had spread down the arm to roughly the elbow. The site was no longer warm. It was still slightly irritable. As the day is progressing (this is written on day 9), the rash is starting to fade.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,UNK,,,,,Penicillin,"['Fatigue', 'Injection site irritation', 'Injection site pain', 'Injection site rash', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Malaise', 'Musculoskeletal stiffness', 'Pain', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 919404,OH,32.0,F,"C/O heaviness and warmth to neck, shoulder, and back. C/O heart racing- HR 112. BP 143/99. ER diagnosed with allergic reaction- minor. Continue to report warmth and heaviness to mid-upper back.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,None,hx Celiac disease.,hx Celiac disease. Asthma,,Celiac disease. Codeine. PCN.,"['Discomfort', 'Feeling hot', 'Hypersensitivity', 'Palpitations']",UNK,PFIZER\BIONTECH,IM 919405,WI,42.0,F,Patient received a dose of vaccine that may be less than effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,bees,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919406,TX,27.0,F,Extreme right arm soreness- painful to palpation and to lift arm Low grade fever evening of 12/20/20 ranging from 99.4-100.4,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Zyzal, birth control, flonase, spirnolactone",seasonal allergies,,,"Penicillin, amoxicillin","['Pain', 'Pain in extremity', 'Pyrexia', 'Tenderness']",1,MODERNA,SYR 919407,PR,44.0,M,In the area where the vaccine was applied I have it irritated and warm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/04/2021,9.0,UNK,,,trigeminal neuralgia,,,"['Vaccination site irritation', 'Vaccination site warmth']",1,MODERNA,IM 919408,NY,35.0,F,Patient was given vaccine at 1515 and told to wait at facility until 1530. Patient called cf clinic at 1630 stating she had hives. Patient spoke with RN and stated that her hands were itchy on the ride home and she noticed they were swollen. She stated that she developed hives on her chest and hands. Patient denies any chest heaviness or shortness of breath at this time. Doctor consulted and advised patient take benadryl for reaction. Patient was advised if she developes shortness of breath or any further symptoms to come in and seek emergency treatement and she understood. Patient did complete v safe today and reported on there as well.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"gabapentin , metformin, omega 3",none.,"diabetes,",,no known allergies,"['Peripheral swelling', 'Pruritus', 'Urticaria']",1,MODERNA,IM 919409,SC,37.0,F,"Dizziness post vaccine, came back to clinic and ate snack bc she had not eaten that morning. BP 130/80, felt better with food. 2 similar episodes the following day, no further epidose after 48h.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,Wellbutril XL 150mg daily Ibuprofen prn migraine,na,"allergic rhinitis, mild intermittent asthma, depression",,"Watermelon, cantaloupe, no med allergies",['Dizziness'],1,PFIZER\BIONTECH,IM 919410,ID,53.0,F,With in five minutes I stared to itch around my face and eyes. Got dizzy and blurry vision when I stood up. My lips began to swell. Was given 50 mg Benadryl PO and watched for one hour. Never had difficulty breathing. Itchy continued for five days going away with Benadryl. Lymph nodes in arm pit of arm vaccine was in swelled and hurt for two days. Spiked a fever the second day twice that was controlled with Tylenol.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,"Calcium vitamin D, cranberry extract, melatonin, hair skin and nails Vitamin.",None,Thyroid disease hypo. Hypertension,1994 had hives after flu vaccine. In 2010 had local reaction to TDAP vaccine,"Flu shot, TDAP, Bee stings, Sulfa, dog and cat dander.","['Dizziness', 'Dyspnoea', 'Eye pruritus', 'Lip swelling', 'Lymph node pain', 'Lymphadenopathy', 'Pruritus', 'Pyrexia', 'Vision blurred']",1,PFIZER\BIONTECH,IM 919411,MO,40.0,F,"widespread itching, localized itching at injection site, swelling/welting at injection site, red area about the size of an orange around injection site, darkened discoloration like bruising persisting 2 weeks following first inection . Reported to Employee Health",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,"levonorgestrel and ethinyl estradiol tablets, once daily Linzess once daily",,,,,"['Injection site bruising', 'Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Pruritus', 'Urticaria']",1,MODERNA,IM 919412,,32.0,F,"Arm very sore at injection site a few hours after vaccination, and for about 2-3 days afterward. Moving the arm helped alleviate the soreness. Also took a bath and ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,UNK,,,,,,['Injection site pain'],1,MODERNA,IM 919413,PR,69.0,F,"swelling , itching, pain ,redness, hot area. Started Xyzal and Prednisone 5 mgs, Panadol 500 mgs, cold compresses for about 3 days. then in January 1, started antibiotic Augmentin bid, because it became worst. Now with redness , hot area, but improving>I am a Doctor. Moderna Vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,WRK,"VitaminD 10,000U, Glucosamina, Caltrate 600 mgs, Tumeric,","Hypertension, Osteoporosis",,"Shingrix Oct 28 ,2020. at age 69. redness and itching in area",Aspirin,"['Erythema', 'Feeling hot', 'Pain', 'Pruritus', 'Swelling']",,MODERNA,IM 919414,NH,48.0,F,headache (base of skull) and neck pain (back of neck),Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Losartan, HCTZ, Singulair",Hypertension,Pituitary Tumor,,"Phenergan, Tylenol, Peanuts, Tree nuts","['Headache', 'Neck pain']",1,PFIZER\BIONTECH,IM 919415,WI,54.0,M,"Body aches and joint pain, swollen lymph node on right armpit, temperature of 101'F starting on 1/1",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Albuterol, Amlodipine, Atenolol, Atrovastatin, Gemfibrozil, Insulin, Jaridiance, Losartan, Metformin, Omega 3, Omeprazole, Sitagliptin, Spirolactone",Ear ache,"HTN, Hypertriglyceridemia, Type 2 diabetes, Microalbuminuria, Low HDL, fatty liver, CKD stage 1",,Ciprofloxin,"['Arthralgia', 'Body temperature increased', 'Lymphadenopathy', 'Pain']",1,PFIZER\BIONTECH,IM 919416,WI,40.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,penicillins,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919417,OR,46.0,F,"On day two I noticed a golf ball sized lump at injection site. It was there until day 4 or 5 when it started to go away, but never went away completely. It was sore, but not very painful. On day 10, I noticed it was more sore and now there is a lot of redness over injection site. The lump is a little bigger, but not as big as it was originally.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/27/2020,1.0,PVT,"Avapro, HCTZ, Prilosec, Wellbutrin, Multivitamin, Vitamin C, Melatonin",none,High blood pressure,,Sulfa drugs,"['Injection site erythema', 'Injection site mass', 'Injection site pain']",1,PFIZER\BIONTECH,IM 919418,CT,48.0,F,"Patient developed shortness of breath and tachycardia/palpitations in the evening after receiving the vaccine, as well as ""pins and needles"" sensation over her torso.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,PVT,acyclovir,None,genital herpes,,PCN (anaphylactic) Erythromycin (hives) Peanuts (anaphylaxis),"['Dyspnoea', 'Palpitations', 'Paraesthesia', 'Tachycardia']",1,MODERNA,IM 919420,GA,50.0,F,103 fever on and off x 2 days; dizziness x 1 1/2 day; swollen/painful lymph nodes x 4 days; body aches/fatigue x 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,Estradiol 5mg 1cc monthly; Lisinopril 10mg daily,none,,,none,"['Dizziness', 'Fatigue', 'Lymph node pain', 'Lymphadenopathy', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 919421,UT,38.0,F,"Employee started having symptoms 5 hours after administration of vaccine. Had headache and chills. Slept through the night. Woke with fever, chills, body aches and tics, chest pain, headache, nausea, difficulty breathing, lethargy and decreased level of responsiveness. Was admitted to the ED on 12/29/2020 at 11:37 am. Temp 37.7, HR 88, RR 22, BP 122/86, SaO2 98%. Glasgow coma score was 15. She was oriented to person, place and time but responses were short and slow. Work up in the ED included, EKG, chest x-ray, CT of brain, and Labs(CBC & chemistries). She was also given Acetaminophen 650mg for head ache, Ketorolac 30 mg for pain, Ondansetron 4mg for nausea, and 2 liters of LR. Observed for 5 hours with some improvement in symptoms and discharged at 5:10 pm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,,Tested Covid positive on 12/10/2020,,,Tamiflu,"['Chest X-ray normal', 'Chest pain', 'Chills', 'Computerised tomogram head', 'Computerised tomogram normal', 'Dyspnoea', 'Electrocardiogram normal', 'Full blood count normal', 'Headache', 'Hyporesponsive to stimuli', 'Laboratory test normal', 'Lethargy', 'Nausea', 'Pain', 'Pyrexia', 'Tic']",1,MODERNA,IM 919422,KY,30.0,F,"A week after receiving the COVD19 vaccine, red patches of skin started appearing around the injection site. Patches were not itchy. Armpit area (lymph nodes) was painful, as well as general pain in left arm. The next day the rash had gotten larger and left arm started tingling. Arm pain persisted. On the third day the rash was larger still, with prolonged arm tingling and left chest area pain. I went to the ER as no one could answer why these problems were arising a week after the vaccine. ER advised taking Benadryl and watching out for shortness of breath. Arm is currently tingling and eyesight seems fuzzy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PUB,"Magnesium chelate, allergy shots (not taken that week), cetrizine HCl taken daily, oral birth control, Viibryd",,"Asthma, allergies",,"Erythromycin, penicillin","['Axillary pain', 'Chest X-ray normal', 'Chest pain', 'Electrocardiogram normal', 'Injection site erythema', 'Lymph node pain', 'Pain in extremity', 'Paraesthesia', 'Rash', 'Vision blurred']",1,MODERNA,IM 919423,NY,46.0,F,Turned red and flushed within 5 minutes of vaccine administration. Lasted for about 60 minutes. No issues breathing.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,WRK,"Bystolic, Amlodipine",None,Hypertension Allergies Asthma,,"Penicillin, Shellfish, Mold, Aged Cheese","['Erythema', 'Flushing']",1,PFIZER\BIONTECH,IM 919424,KS,39.0,M,"Left eye swollen 24 hours later, took Benadryl in ED and resolved right away",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/18/2020,1.0,PVT,,,,,,['Eye swelling'],1,PFIZER\BIONTECH,IM 919425,WI,53.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,meperidine,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919426,GA,63.0,M,"Patient reports having a 1 cm x 1.5 cm "" blister- like "" lesion at his injection site since 01/03/2021 at 7:00 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PUB,"Omeprazole , Zyrtec",Patient denies.,GERD,,Pineapples,['Injection site vesicles'],UNK,MODERNA,IM 919427,OH,32.0,F,"Moderna vaccine on 12/31/2020. The next day, Friday she had a sore left arm, that was it. No redness or swelling at the injection site.. On Saturday she had a dry cough with deep inspiration, chest tightness, and shortness of breath and left shoulder pain requiring aleve and heating pad. Saturday she used her rescue inhaler a few times, Sunday she used it 2-3 x and one time today. Ongoing chest tightness . Got order for 5 days of steroids and epi pen prescription",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,WRK,"albuterol HFA 90 mcg/actuation inhaler Prn amitriptyline 75 mg tablet Po daily Amphetamine-Dextroamphetamine 30 mg tablet buPROPion XL 300 mg 24 hr tablet Cholecalciferol (Vitamin D3) 50 mcg (2,000 unit) Cap clobetasol 0.05 % cream ELURYN",None,"Sleep apnea, migraines, obesity, hypothyroid, depression, adhd, exercise induced asthma, neck pain, vertigo",,Adhesive,"['Chest X-ray normal', 'Chest discomfort', 'Cough', 'Dyspnoea', 'Injection site pain', 'Pain in extremity']",1,MODERNA,IM 919428,TX,58.0,F,"Felt slight warmth throughout body about 5 minutes after vaccine. Disappeared 2 minutes later. Arm started to feel sore as the day went on and was very sore by nighttime. Next day, arm started to feel better and over the next 3 days was no longer sore. On the morning of the 30th, woke up feeling fine, took a 3.5 mile walk and felt fine. Around 12:30 pm, experienced sudden pain and a burning sensation in the chest and both upper arms. Thought it was possibly heartburn ; took a Prilosec. The discomfort (mild but steady) continued so checked blood pressure which was 141/91. Called cardiologist and went to emergency room per instruction, around 1:30. Admitted overnight with the diagnosis of a mild heart attack and performed a heart catheterization where they found no major blockage. One artery noted 30% blocked but that overall heart function looked good. Discharged on 12/31/2020. -reported by patient via email, on 1/3/2021 @ 4:49pm",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/26/2020,12/30/2020,4.0,PVT,clopidogrel lisinoprel carvedilol rosuvastatin aspirin symbicort melatonin mvi vitamin d3,none,mitral valve takotsubo cardiomyopathy myocardial infarction 2011 migraines htn,,nka,"['Angiogram', 'Burning sensation', 'Catheterisation cardiac normal', 'Chest pain', 'Discomfort', 'Feeling hot', 'Myocardial infarction', 'Pain in extremity', 'Troponin increased']",1,MODERNA,IM 919429,OR,40.0,F,Vomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2020,01/04/2020,0.0,WRK,"Nexplanon, Ibuprofen as needed, Imitrex as needed, recent cortisone shot, CBD balm",Frozen shoulder,Migraines,,"Penicillins, Sulfas, Erythromycin, Lavender oil",['Vomiting'],1,MODERNA,SYR 919430,CA,55.0,F,"12/29/20 Headache, dizziness. Woke at midnight with headache, flushed face, could not get warm. Heart rate 95, respiratory rate 25. At approximate 2:00 am woke with HEADACHE, flushed face, Temp 101.1. 12/30/2020 Continues to c/o of dizziness, Huge headache, Ibuprofen not effective",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Body temperature increased', 'Dizziness', 'Feeling cold', 'Flushing', 'Headache']",1,MODERNA,IM 919431,PA,72.0,M,"Anterior Uveitis in the Left Eye; blurry vision, injected sclera in left eye started on 1/3/21; evaluated for and diagnosed with Anterior Uveitis of Left Eye at Hospital Emergency Department on 1/4/21, and prescribed topical steroids upon same-day discharge.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PVT,"Metformin, Sitagliptin, Pioglitazone, Azetimibe, Atorvastatin, Ramipril, Hydrochlorothiazide",No Illnesses at time of vaccination,"I have the following chronic and well controlled conditions: hyperlipidemia, diabetes mellitis type 2, and hypertension",,No known Allergies,"['Iridocyclitis', 'Ophthalmological examination abnormal', 'Vision blurred']",1,PFIZER\BIONTECH,IM 919432,WI,39.0,F,"Severe headache, vomiting, chills within one hour of vaccine, full body rash and itching 12/29 through ongoing, swollen feet resulting in inability to walk 1/4/2021 (PCP suggests erthyema nodosum); treated with Claritin",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,WRK,None,"Had routinely tested for COVID on 12/28 as required by employer but had no symptoms,got positive results of test on 12/30",Asthma,,"Codeine, morphine, Demerol, environmental allergies such as grasses, trees, dander, mold","['Chills', 'Erythema nodosum', 'Gait inability', 'Headache', 'Peripheral swelling', 'Pruritus', 'Rash', 'Vomiting']",1,MODERNA,SYR 919434,SC,21.0,F,"On Sunday, December 27, I had the injection. I was fine. Monday the 28th, I was in pain in my arm. December 29 to currently ( January 4 2021) I am sick. I believe I got it from the vaccine. I have been out of work for two weeks. I will not go get the other vaccine. I thought I was protecting myself but find out I am not. I am currently laying in bed sick as a dog. I have shortness of breath, cough, sneezing,sore throat, and bodyaches. I am in severe pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/29/2020,2.0,WRK,None,None,None,,None,"['Cough', 'Dyspnoea', 'Impaired work ability', 'Malaise', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'SARS-CoV-2 test', 'Sneezing']",1,PFIZER\BIONTECH,IM 919435,TN,24.0,F,My arm has not stopped twitching since I have received the vaccine 2.5 hours ago. I can still use it. It is a localized twitch on the back side of my arm an inch above my left elbow (same side as injection).,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,SCH,Adderall,,,,Doxycycline,['Muscle twitching'],1,PFIZER\BIONTECH,IM 919436,IL,29.0,M,"Bell?s palsy, right side of face is numb, with difficulty closing eyes, smiling, raising eyebrows, eating, drinking, swallowing.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/29/2020,01/01/2021,3.0,UNK,,"Strained neck resulting in numbness in extremities. This and facial numbness prompted me to see my PCP who urged me to go to the ER immediately. I went to Medical Center's ED, after which I was admitted to the neuro ICU for a possible brain bleed, which after an MRI was determined to be a cavernoma.","Depression, anxiety, seasonal allergies",,,"['Blood test', 'Computerised tomogram', 'Dysphagia', 'Eyelid function disorder', 'Facial paralysis', 'Hypoaesthesia', 'Magnetic resonance imaging']",1,PFIZER\BIONTECH,IM 919437,WV,37.0,F,"Started having tingling in her mouth, post nasal drip, and feeling like her skin in her mouth was sloughing off an hour later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,Tramadol hydrochloride,"['Oral mucosal exfoliation', 'Paraesthesia oral', 'Upper-airway cough syndrome']",1,PFIZER\BIONTECH,IM 919438,KS,54.0,F,48 hours later bilateral eyes swollen. Saw dr. in office and treated with steroid cream and allergy meds resolved without difficulties,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/20/2020,2.0,PVT,,,,,,['Eye swelling'],1,PFIZER\BIONTECH,IM 919439,WI,33.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,"levonergestrel, cymbalta","['No adverse event', 'Product storage error']",1,MODERNA,IM 919440,IN,39.0,F,"Severe anterior right shoulder pain associated with very limited ROM due to pain. No pain at injection site. No swelling or erythema at injection site. Pain is in anterior shoulder and radiates down right arm. Pain is constant but worse with movement. Pain started the night that vaccine was given 1/2/2021 and has been persistent since then making it difficult to work. Pain not relieved with tylenol or ibuprofen. Pain is more severe that what would be expected from needle trauma. Of note, vaccine was given particularly high near subdeltoid bursa.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,none,none,none,,none,"['Arthralgia', 'Impaired work ability', 'Joint range of motion decreased', 'Pain', 'Product administered at inappropriate site']",1,PFIZER\BIONTECH,IM 919441,GA,58.0,F,Moderna COVID-19 Vaccine EUA reddness at injection site - noticed 10 days past injection; no itching or pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/03/2021,11.0,UNK,Allegra Singular Mirlax,none,none,,none,['Injection site erythema'],UNK,MODERNA,SYR 919442,FL,55.0,F,"Day of vaccine approximately 30 minutes later patient experienced warm sensation in chest, progressed to muscle aches, swelling of foot/ankle. On 1/3/2021 patient still complains of muscle/body aches, joint pain, swelling of foot. On oral steroid for foot swelling. >10days with no improvement.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,none,none,none,,none,"['Arthralgia', 'Chest discomfort', 'Feeling hot', 'Joint swelling', 'Myalgia', 'Pain', 'Peripheral swelling', 'SARS-CoV-2 test negative']",1,MODERNA,IM 919443,GA,58.0,F,"S: Employee received Covid vaccination on 12/28/20. Employee reported noticing ""itching all over my body"". The following day she experienced nausea and moderate joint pain. She then also experienced redness on forehead, ears and ""felt like they were on fire."" B: Covid vaccination on 12/28/20. Employee contacted advice nurse and was instructed to report to ACC A: Employee reported to ACC on 12/29/20 and received solumedrol shot R: Reporting for tracking purposes",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,PVT,Outpatient Medications at End of Encounter on as of 12/28/2020 Disp Refills Start End Cephalexin (KEFLEX) 500 mg Oral Cap 14 capsule 0/0 12/4/2020 12/4/2021 Sig - Route: Take 1 capsule by mouth 2 times a day for 7 days for infection - Ora,"ICD-10-CM Priority Class Noted - Resolved MENOPAUSAL HOT FLASHES (Chronic) N95.1 5/14/2012 - Present MENOPAUSAL SYMPTOMS (Chronic) N95.1 9/12/2012 - Present MIGRAINE (Chronic) G43.909 9/12/2012 - Present VARICOSE VEINS OF BILAT LEGS W INFLAMMATION I83.11, I83.12 9/12/2012 - Present HIGH DENSITY LIPOPROTEIN DEFICIENCY (Chronic) E78.6 9/28/2012 - Present VITAMIN D DEFICIENCY E55.9 9/28/2012 - Present HX OF TOTAL HYSTERECTOMY W HX OF BENIGN DISEASE (Chronic) Z90.710, Z87.898 11/14/2012 - Present FHX OF COLON POLYP Z83.71 6/18/2013 - Present INSOMNIA G47.00 6/21/2013 - Present CARDIOVASCULAR STRESS TEST NEGATIVE FOR ISCHEMIA ADMIN CODE 8/21/2013 - Present Overview SLEEP APNEA (Chronic) G47.30 10/11/2013 - Present ADJUSTMENT DISORDER W ANXIETY F43.22 11/27/2013 - Present PREDIABETES (Chronic) R73.03 8/6/2014 - Present HX OF LASIK Z98.890 1/9/2015 - Present BILAT DRY EYE SYNDROME H04.123 1/9/2015 - Present PRESBYOPIA H52.4 1/9/2015 - Present BRONCHITIS J40 9/15/2015 - Present ACUTE SINUSITIS J01.90 9/15/2015 - Present HYPERLIPIDEMIA (Chronic) E78.5 1/25/2016 - Present ABNL LIVER FUNCTION STUDY R94.5 5/16/2016 - Present RIGHT BUNDLE BRANCH BLOCK I45.10 8/30/2016 - Present ADULT OBSTRUCTIVE SLEEP APNEA (Chronic) G47.33 2/22/2017 - Present MAJOR DEPRESSIVE DISORDER, RECURRENT EPISODE (Chronic) F33.9 9/4/2018 - Present",See Item #11 above,,Lortab & Morphine,"['Arthralgia', 'Ear discomfort', 'Erythema', 'Nausea', 'Pruritus', 'Skin burning sensation']",1,PFIZER\BIONTECH,IM 919444,NY,34.0,F,"12/21 had covid vaccine (dose 1). On evening of 12/29 had sudden onset of mild neck pain and significant weakness and numbness of left arm, weak hand grip, clumsiness in hand . Did not improve after trying to shake arm/move around , and took prednisone 40mg oral. Went to ER and had CT Cspine which did not show evidence of cervical pathology. Continued with corticosteroids, sought consultation with PMR and neurology specialists, and steroid dose increased to 60mg/day. Some improvement in strength , but still have diminished sensation and strength in left hand/arm. Unable to perform full job tasks as I am left hand dominant. Likely brachial neuritis / parsonage turner syndrome per both specialists seen. Continuing with corticosteroids at this time, pending bloodwork and OT evaluation",Not Reported,,Not Reported,Not Reported,,Yes,N,12/21/2020,12/29/2020,8.0,PVT,Balziva ( birth control ),None,"Scoliosis, IBS",,None,"['Clumsiness', 'Computerised tomogram spine', 'Grip strength decreased', 'Hypoaesthesia', 'Impaired work ability', 'Muscular weakness', 'Neck pain', 'Neuralgic amyotrophy', 'Radiculitis brachial', 'Sensory loss']",1,PFIZER\BIONTECH,IM 919445,SC,44.0,F,"I started getting a headache on 12/22 with nasal congestion worsening over night the next day I continued having congestion and headache, I called employee health and received a covid test which was negative. I continued to have headache and congestion for two more days and the 25th I was really tired and took a nap. By the 26th I felt completely normal",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/23/2020,5.0,PVT,no,no,no,Flu shot hurts my arm,bactrin,"['Fatigue', 'Headache', 'Nasal congestion', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,SYR 919446,WI,48.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect noted,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919449,TN,78.0,F,"PATIENT REPORTS APPROXIMATELY 5-10 MINUTES AFTER RECEIVING VACCINE TO LEFT ARM THAT ""MY HEAD FELT WEIRD AND I GOT A PAIN TO MY LEFT EAR FOR A SPLIT SECOND."" SHE REPORTS IT CAME AND LEFT VERY QUICKLY. UNABLE TO DESCRIBE WHAT THE HEAD FELT LIKE OTHER THAN WEIRD. REPORTED FEELING COMPLETELY NORMAL AFTER OCCURANCE",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PUB,,,,,,"['Ear pain', 'Head discomfort']",1,PFIZER\BIONTECH,IM 919450,OH,57.0,F,Hives at site of injection and down Left arm continue past five days post injection Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PUB,"Lemimeir, fluxatine, clonidine, jardiance",,Diabetic,Localized redness and swelling,codiene,"['Headache', 'Injection site urticaria']",1,MODERNA,IM 919451,OK,39.0,M,"I had a persistent headache on day 1 after the vaccination. Also, had severe fatigue and later that day I had chills with severe myalgia that lasted 48 hours requiring to take Ibuprofen for 2 days. The sourness in my left arm was more pronounced that with any other vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,SCH,,Had a Covid + infection 3 weeks prior to the vaccine administration,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 919452,WI,50.0,F,Its been 30 min now and she is doing much better. Felt tingling in her arm and leg on side that vaccine was given. Felt nauseous. Also had headache. Pt has had a severe ischemic stroke in past and has an intellectual disability. Pt seems to be doing fine otherwise and is slowly improving.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,SEN,,No,Chronic isch stroke,,None,"['Headache', 'Intellectual disability', 'Nausea', 'Paraesthesia']",1,MODERNA,IM 919453,CA,49.0,F,"Right wrist rash, 4cm x 2.5cm, with vesicles that drained clear fluid after severe itching relieved by scratching. Left hand rash, of the webbing between the thumb and forefinger, raised. Not as severe as the wrist. Numbness or tingling of the lips, intermittent, first occurred an hour after the vaccine and has been infrequent since then. Gradually reducing in frequency; described as an awkward sensation of tingling. Has contacted her PCP for an appointment. Local Pharmacy would not sell or recommend medications due to the patient's history of Pfizer vaccine without her having been diagnosed first.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,WRK,"Synthroid, Advil, Tylenol",None,Hypothyroidism,,NKDA/EA/FA,"['Hypoaesthesia oral', 'Paraesthesia', 'Paraesthesia oral', 'Rash', 'Rash papular', 'Rash pruritic', 'Rash vesicular']",1,PFIZER\BIONTECH,IM 919454,MA,42.0,F,"Developed wheezing/chest tightness. No stridor or rash or injection site symptoms. Took Benadryl 50mg q4 x 3 doses, took albuterol every 2 hrs for 8 hrs. Had EpiPen nearby (a family member's, not mine), but did not use. Felt fine the next morning, 24 hrs afterwards. Just mild headache for a few days (not unusual for me)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,WRK,Loratadine 10mg daily,,"Seasonal allergies (prior history of asthma in childhood, but no symptoms or medications for many years)",,Codeine,"['Chest discomfort', 'Headache', 'Impaired work ability', 'Wheezing']",1,PFIZER\BIONTECH,IM 919455,NY,16.0,M,Vaccine administered to 16 year old patient in error; FDA authorized emergency use of administered vaccine for patient's 18 years and older. Patient was monitored for 15 minutes following vaccine administration; no adverse reaction noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 919456,WI,32.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919457,NV,54.0,M,Reaction began to appear on 02 Jan 2021 (Day+2). Sore neck muscles 03 Jan 2021: Neck muscles stiffen and preclude rotation of the head. Pain radiating from shoulders up through neck to top and side of head. Neck and muscles sore to the touch. Fatigue. Loss of appetite. Joint pain in all major joints. Inability to sleep from pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,"Metformin, glipizide, potassium citrate, lisinopril, omeprazole, wellbutrin, and febuxostat",None,Diabetes Type II Hyperuricemia,,PCN and Compezine,"['Arthralgia', 'Blood test', 'Decreased appetite', 'Fatigue', 'Headache', 'Mobility decreased', 'Musculoskeletal stiffness', 'Myalgia', 'Neck pain', 'Pain', 'Tenderness']",1,MODERNA, 919458,AL,56.0,F,"Around 2AM I was sitting at work and I looked at my co-worker and told her my head was killing me. I took Advil, it was like the worst ""flu shot"" I ever got. Then the muscle pain started. I went home and took some Advil, tried to walk my dogs and couldn't. I usually walk 3 miles with them and did not walk even 1/2 mile. Went home and took a hot shower with Epson salt and laid down. My arm started aching. I can't even wash my hair, the injection site itches and is painful and my scalp was itching too. Overall headache, joint/ muscle pain like flu like symptoms. Wednesday morning before I left work my back started hurting really bad, severe back pain. When I arrived home and used the bathroom I was having abd pain, and diarrhea. It was all fluid. I ate some chili the day before and when I wiped my bottom it was red like bloody. My PCP was closed. It happened about 4 times. It is like I have a kidney pain (the back pain)",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,PVT,"Vitamin D3, Vitamin C and Selexa, Zyrtec","Low grade fever, I had an UTI and kidney infection in October.",Breast cancer survivor (remission 3 years),,Unknown,"['Abdominal pain', 'Back pain', 'Diarrhoea', 'Diarrhoea haemorrhagic', 'Headache', 'Influenza like illness', 'Injection site pain', 'Injection site pruritus', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Myalgia', 'Pain in extremity', 'Pruritus', 'Renal pain', 'SARS-CoV-2 test']",1,MODERNA,SYR 919459,CO,34.0,M,"MODERNA COVID-19 VACCINE EUA Approximately 12 minutes in to the patient's 15 minute post vaccination observation period he reported new onset headache. No reported symptoms of anaphylaxis at this time; the patient was alert and oriented x4. The patient was asked to wait for an additional 15 minutes of observation. After 15 more minutes of observation, the patient continued to endorse a headache and fatigue; no additional symptoms present and the patient was alert and oriented x4. We reviewed common side effects which include headache and fatigue as well as signs of anaphylaxis. We made a plan for patient to contact PCP for any changes or concerns or to contact emergency medical services for evidence of anaphylaxis. Client was discharged from the clinic following a second 15 minute observation period with no acute change in status.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PUB,,None reported by patient at time of vaccination,None reported by patient at time of vaccination,,None per patient report,"['Fatigue', 'Headache']",1,MODERNA,IM 919460,MD,54.0,F,Moderna COVID-19 Vaccine EUA. Muscle aches and headache resolved within 24 hours starting on second day post vaccine. Tylenol and Advil taken as recommended for 24 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Synthroid, ASA, Lexapro, Probiotic, Vit D, Cranberry pill, Tylenol",none,Hypothyroidism,,no,"['Headache', 'Myalgia']",1,MODERNA,IM 919461,WI,21.0,M,Patient received a dose of vaccine that may be less than completely effective because of storage conditions. No adverse effect noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919462,MI,52.0,F,Patient returned after receiving vaccine with unit nurse complaining of flushing in upper body. Temperature was immediately taken and was 97.2 forehead. She was asked to be seated and monitored for her heart rate. Breathing appeared normal. Patient then complained of having swelling in her throat and difficulty swallowing. She was then offered a diphenhydramine 25mg tablet PO. Patient took with water. No help. I offered to call 911. She accepted. Paramedics arrived. Conducted diagnostics. BP was 150/80 with HR 80. AMR administered diphenhydramine 50mg via IV and patient was placed in stretcher and taken to Hospital. Facility with follow up with care.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,SEN,unknown,,diabetes,,nka,"['Dysphagia', 'Flushing', 'Pharyngeal swelling']",1,MODERNA,IM 919463,IA,43.0,F,Induration pain and warm to touch. Induration site larger than silver dollar.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/28/2020,5.0,PVT,Fluoxetine Protonix,none,none,,Clarithromycin,"['Induration', 'Pain', 'Skin warm']",1,MODERNA,IM 919464,IN,53.0,F,"I developed a raised rash on my left arm at injection site , had chills and nausea and lots of tenderness at injection site at 3 am (1/1/21) following injection. The nausea had resolved when I woke up, the rash subsided throughout the day as did the chills. The most distressing event began on 1/1/2021 , that being sneezing, runny nose and watery eyes which continued and got much worse over the next two days, despite taking sudafed as often as possible. No other cold or flu symptoms were present and it felt like allergies although I have never had any sort of seasonal allergies. I finally took Zyrtec for it the evening of 1/3/21 and the symptoms stopped. Congestion, light sensitivity remain. I am reluctant to take another dose due to drowsiness side effect. Hoping symptoms will all be gone by tomorrow.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,"Vitamin C, Vitamin D, Zinc, Multivitamin, Black Elderberry Extract, Curcumin",None,None,,Celebrex,"['Chills', 'Injection site pain', 'Injection site reaction', 'Lacrimation increased', 'Nausea', 'Photophobia', 'Rash papular', 'Respiratory tract congestion', 'Rhinorrhoea', 'Sneezing']",1,PFIZER\BIONTECH,IM 919465,WI,19.0,F,"Patient felt like she was going to pass out but did not. She complained on feeling nauseous and throwing up multiple times. She did not have shortness of breath or palpitations. After sitting for a while, she was given an ice pack and a fan. Around 3:15 she felt good enough to leave and she was picked up by someone else.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,Unknown,None known,None,,None,"['Dizziness', 'Nausea', 'Vomiting']",1,MODERNA,IM 919466,WI,61.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 919467,OK,33.0,F,"Patient got the shot on Saturday, Jan 2nd at around 11am. Woke up Jan 4th at 2:13am feeling the place of injection swollen, itchy and with a single hive like a bug bite, felt another on torso on the right side. Felt rapid pulse, got up to check the mirror, eyes swollen and itchy, tongue beginning to swell. Within minutes, started feeling itchy all over my body, specially mucosae, and scalp. Took 360mg of fexofenadine and 20mg famotidine, reaction started to subside. Was up monitoring until 3:45am. Still feeling itchy but significantly less at the before medication. Plan to continue with 180mg fexofenadine a day until all itchiness goes away.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/04/2021,2.0,PUB,unknown,COVID positive PCR on 12/04/2020,Mastalgia,,Latex ASA,"['Eye pruritus', 'Eye swelling', 'Heart rate increased', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria', 'Oral pruritus', 'Pruritus', 'Swollen tongue', 'Urticaria']",1,MODERNA,IM 919468,RI,38.0,M,Positive COVID test with COVID symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/02/2021,6.0,WRK,None,None,None,,None,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 919469,TX,64.0,F,"By evening of the same day I read the vaccine my right side got numb my cheek and eye hurt to the touch, my eye socket was very sore, like if I was getting Bells Palsy. I took Vitamin B12 sublingual and went to bed and the next day it was still sore but I took the vitamins again and later on it subsided. By the first of the month those symptoms were a lot less and now I am fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,Calcium 600mg Biotin 5000 mg Fish oil 1200mg Vitamin D3 5000IU Nitrofurantoin,UTI,None,,NONE,"['Eye pain', 'Hypoaesthesia']",1,PFIZER\BIONTECH,IM 919470,GA,26.0,F,Immediately after injection a nodule formed to side of injection site. Bump eventually subsided but area remained swollen and red to touch for 3 days. Now area is still red a week later and slightly itchy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,"Trazodone, birth control",Congestion,N/a,,Z pack,"['Immediate post-injection reaction', 'Injection site erythema', 'Injection site nodule', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 919472,CA,42.0,F,Lip and facial area swelling tow days after receiving vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/30/2020,2.0,PVT,Notice lip and facial area swelling two days after receiving vaccine,,,,,"['Lip swelling', 'Swelling face']",1,PFIZER\BIONTECH,IM 919473,WA,47.0,M,"sudden onset of chills, headache, generalized body aches with malaise on wednesday afternoon starting around 1400. progressed to alternating fever+chills when i got home at 1900. took advil at 2100. with mild relief from symptoms. symptoms continued throughout thursday and into friday, with the addition of sore throat and fatigue. switched to tylenol x2/day. large red erythematous area right below injection site of left deltoid noticed on friday and thursday. warm and tender to touch. all symptoms subsided by saturday.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,UNK,none,none,none,,none,"['Chills', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Malaise', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 919474,WI,51.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. Patient also reported a persistent headache for several days post vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['Headache', 'Product storage error']",1,MODERNA,IM 919475,TN,41.0,U,"Around 11am the 23rd I starting having chills, low grade fever, severe body aches. Went to walk in clinic (Urgent Care) around 6pm that evening and had Covid and Flu test, both came back negative. Body aches lasted thru the night had to take medicine, body ache and head ache last two days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/23/2020,5.0,WRK,,,,,,"['Chills', 'Headache', 'Influenza virus test negative', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,SYR 919476,,51.0,F,Patient has a presumed fever (shaking chills) and increasing shortness of breath that started this morning (1/4/2021),Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/04/2021,2.0,UNK,,,Asthma,,,"['Chills', 'Dyspnoea', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 919477,MT,54.0,F,"slight fever, strong body ache for 1.5 days and strong headache for 2.5 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,Collagen with peptides,none,none,,none,"['Headache', 'Pain', 'Pyrexia']",1,MODERNA,SYR 919478,TN,75.0,F,Pt. co of feeling flushed and feeling funny. Patient was flushed and b/p 142/80 r arm. Pt observed 10 mins and she sated that she was feeling worse and scared . No noted shortness of breath. B/p rechecked 110/80.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,PUB,unsure,unsure,unsure,,unsure,"['Fear', 'Feeling abnormal', 'Flushing']",1,MODERNA,IM 919479,IN,56.0,F,"They have my injection listed as Moderna which is a mistake. The Manufacturer is Pfizer. On the 23rd. I went into anaphalactic shock admitted to the ER, given an epinephrine drip, I was given iv bolises, chest xray, vitals were taken and blood was drawn. ABGs and chest xray and lactic acid tests were administered. I have to carry a epi pen and need to see a pulmonologist, I have triggers now where I need an emergency inhalor and was put on a course of steroids and my heartbeat is 20 beats higher than usual. I was really tired and having abdominal pain .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,SCH,vitamin D and priobiotic,no,no,,no,"['Abdominal pain', 'Anaphylactic shock', 'Blood gases', 'Blood lactic acid', 'Blood test', 'Chest X-ray', 'Fatigue', 'Heart rate increased']",1,PFIZER\BIONTECH,SYR 919480,OR,37.0,F,"I waited a full 30 min after my injection due to my peanut allergy. Left hospital feeling ok- on drive home began to feel flushed in my face, tingling in my lips and began to wheeze. It felt like my peanut allergy but on a smaller scale. I took my Albuterol inhaler and some Benadryl once I got home and felt better. The next day I still have some itchiness and fullness in my throat but nothing like yesterday.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,Albuterol for asthma and Zyrtec for allergies (seasonal),Herpes Zoster infection in left eye area one month prior,"Asthma, Crohns Disease/IBD (large intestine, gallbladder, appendix, R OVARY removed) Herpetic Ulcers in left eye, Endometriosis (from surgery)",,Severe peanut (all nuts) allergy- anaphylaxis. Percocet-vomiting. Compazine-muscle tetany I also have Crohn?s disease which makes my system overly sensitive.,"['Flushing', 'Oropharyngeal discomfort', 'Paraesthesia oral', 'Throat irritation', 'Wheezing']",1,MODERNA,IM 919481,AZ,78.0,M,"Very dizzy and very weak, tired. Walks with walker, difficult moving around.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,MIL,"Bisoprolol, Clopidogrel, Gabapentin, Lantus-u-100 insulin/ per day, Lipitor, Lisinopril, Methenamine.",no,Diabetes,,Yes but can't think of the name. It goes under the tongue.,"['Asthenia', 'Dizziness', 'Fatigue', 'Gait disturbance', 'Walking aid user']",1,PFIZER\BIONTECH,SYR 919482,MT,64.0,F,"Left arm rash redness at site developed on the eighth day 4 inch x 4 inch, increased back pain with Lt leg sciatica unknown if related",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/31/2020,9.0,OTH,"ASA 1000mg, Spironolactone 25mg Bid, valsartan 160 mg , Methocarbamol 750 mg, Fineseride 1mg hs,Curamin",Severe inflammation in spine with Lt leg sciatica,"High blood pressure , arthritis Y",,Latex ( rash),"['Back pain', 'Condition aggravated', 'Injection site erythema', 'Injection site rash', 'Sciatica']",1,MODERNA,IM 919483,WI,43.0,F,"Patient felt tingling and vibrating in all extremities right after the vaccine. She was hyperventilating. Had o2 sats between 98-100. HR ranged from 100-117. She was clammy with no chills. Rapid COVID test performed and it was negative. Because the patient complained of trouble breathing and was about to use her AuviQ, paramedics were called. The patient did go with the paramedics.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/24/2021,20.0,OTH,Has epipen she carries with her. She took a Benadryl after the vaccine,Unknown,None,,Yeast,"['Cold sweat', 'Dyspnoea', 'Hyperventilation', 'Paraesthesia', 'SARS-CoV-2 test negative', 'Vibratory sense increased']",1,MODERNA,IM 919484,IN,56.0,F,I went into anaphalactic shock almost immediately after the injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,SCH,vitamin D and priobiotic,no,no,,no,['Anaphylactic shock'],1,PFIZER\BIONTECH,SYR 919485,TX,49.0,F,"My Arm is swollen, angry, red and fever. I am having double, vision, when I walk I feel weird.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PHM,"20 mg furosemid , pantoprazole 40mg , phintermine 37.5 , asprin 81 mg , VD3, Vit C. Zinc.",Polycythemia Vera,Polycythemia Vera,Flu vax twice in one year,"Hydro, Codine, Sincular","['Diplopia', 'Erythema', 'Feeling abnormal', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",UNK,MODERNA,IM 919487,CA,48.0,M,"Within two or three minutes after receiving vaccine, individual began to complain of feeling light headed and vertigo. Blood pressure was normal before vaccine and elevated during time of complaint. Reaction lasted about 30 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,unknown,unknown,unknown,,unknown,"['Blood pressure increased', 'Dizziness', 'Vertigo']",UNK,MODERNA,IM 919488,FL,24.0,F,"Fatigue, chills, body aches, a body temp of 101.5 F, beginning around 10pm on January 2nd, tested with Tylenol around 5am on January 3rd, fever resided for a few hours before coming back once more around noon on January 3rd, took more Tylenol and all symptoms have since not come back",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,Levothyroxine 50mcg Norethindrone acetate and ethinyl estradiol 1mg/0.02mg,,Hypothyroidism Asthma,,,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",1,MODERNA,IM 919489,CA,39.0,F,"injection was administered into left joint and not intramuscular. symptoms included nerve intrapment for 3 days with severe pain in the left arm, extending into the wrist. muscles weakness, numbness into the thumb , index and middle finger. Inability to raise arm. pain persists today",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,PVT,"metoprolol, levoxyl, cymbalta, tylenol",none,hypothyroid,,"sulfa, NSAIDS, gluten","['Arthralgia', 'Hypoaesthesia', 'Injected limb mobility decreased', 'Muscular weakness', 'Nerve compression', 'Pain in extremity', 'Product administered at inappropriate site']",1,PFIZER\BIONTECH,IM 919490,GA,50.0,M,"Fever 102.9, fatigue, headache, ache, cough, nasal drip, sneezing",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/01/2021,4.0,WRK,"lyrica, zertec, tylenol, metoprolol, trulicity, metformin, lantus, celebrex, jardiance",none,"RA, asthma, HTN, type II, Hx Lofgrens.",,none,"['Cough', 'Fatigue', 'Headache', 'Pain', 'Pyrexia', 'Sneezing', 'Upper-airway cough syndrome']",UNK,PFIZER\BIONTECH,IM 919491,MO,47.0,M,"client reports of about 7:00 am Friday morning, waking up, he had pain in all this joints, head feeling ""foggy, had a mild headache in the back of his head, feeling fatigue and not his usual self. This lasted about 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/29/2020,1.0,PUB,none,none,none,,none,"['Arthralgia', 'Fatigue', 'Feeling abnormal', 'Headache']",1,MODERNA,IM 919492,CA,25.0,F,"Increase from baseline heartrate of 60 to 110, feeling of mild chest tightness with no abnormal lung sounds, all other vital signs remained within normal limits. Stated throat felt slightly itchy, resolved without treatment after 2 hours. Patient kept under observation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None,None,None,,None,"['Chest discomfort', 'Heart rate increased', 'Throat irritation']",UNK,PFIZER\BIONTECH,IM 919493,CA,28.0,F,"1616: Vaccination 1630: C/o throat swelling and scratchy throat. Denies pruritis on body. Hx of food allergies with same symptoms. Usually takes Benadryl with relief. 1632: Benadryl 25mg PO 1653: Benadryl 25mg PO 1730: Pt reports symptoms have improved but usually takes a little time to resolved. Awake, alert, oriented, smiling, laughing. No distress noted. Informed Dr. who stated that okay to send home. Informed pt to seek medical attention as needed and then report to COVID hotline. No addition adverse reaction recorded in EMR",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,WRK,none,,,,Hx of food allergies (details unknown),"['Pharyngeal swelling', 'Throat irritation']",1,MODERNA,IM 919494,GA,62.0,F,"Employee received Covid vqaccine, approx. 10 minutes later employee c/o dizziness b/p 178/90 Hr 64 02 sat 97%. Employuee states he is currently being treated by PCP for HTN. offered to call RRT and or transport to ED for evaluation. Employee refused. Recently started new b/p medication prior to leaving observation area employee reports dizziness resolved. b/p 161/93 HR 68 02 sat 97%. Employee to follow up with primary care physician",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,,,,,,['Dizziness'],UNK,PFIZER\BIONTECH,IM 919495,KS,47.0,M,"Dizzines, severe fatigue, injection site pain, mild nausea, headache, body aches/joint pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Omeprozole Cirtirizine Multi vitamin Celecoxib,none,arthritis,,Sulfa No food allergies,"['Arthralgia', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pain']",1,MODERNA,SYR 919496,CO,31.0,F,"I got the Moderna COVID vaccine on 12/23/20 since the spot since has been growing red, dry skin, darker, hot to touch very very itchy, and there is a red line all around it that measures 9cm by 6cm . i have no fever or any other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,WRK,"LEVOTHYRIXINE, METFORMIN, PHENTRAMINE, BUSPAR, ESCITALOPRAM",NONE,NONE,,NONE,"['Injection site discolouration', 'Injection site dryness', 'Injection site erythema', 'Injection site pruritus', 'Injection site streaking', 'Injection site warmth']",1,MODERNA,IM 919497,NY,60.0,F,"itchy skin all over, mild redness , hives. Benadryl shot giving, redness went down along with the itchyness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Lisinopril 10 mg Chlorthalidone 25 MG Turmeric Shot,,hemochromatosis High Blood pressure,,Mold,"['Erythema', 'Pruritus', 'Urticaria']",1,MODERNA,IM 919498,TX,43.0,M,cough and fever,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,PUB,None,None,None,,None,"['COVID-19', 'Cough', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 919499,,39.0,F,Reported lump in her throat and coolness of left arm which was treated with Benadryl 25 mg po; HR=84 and BP=128/88; then had severe cramping in right leg with foot numbness; patient transported to the Emergency Department,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Hypoaesthesia', 'Muscle spasms', 'Peripheral coldness', 'Sensation of foreign body']",1,PFIZER\BIONTECH,IM 919500,CA,35.0,M,Tender L-sided supraclavicular lymphadenopathy lasting 3 weeks and slowly fading away during this time.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/23/2020,4.0,PVT,,,G6PD deficiency,,,['Lymphadenopathy'],1,PFIZER\BIONTECH,IM 919501,AZ,56.0,F,"Light headed, almost passed out several time accompanied by nausea. It would come and go and lasted about 2 hours. Blood pressure spiked and then returned to normal within an hour. Injection site painful for 2 days, extreme tiredness accompanied by headache lasted for 4 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Vitamins,Thought I have COVID-19 a week prior but tested negative.,,Flu shot in October made me ill for a week.,Onions Sulfa drugs,"['Blood pressure increased', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea']",UNK,MODERNA,IM 919502,NC,31.0,F,"36 hours after vaccination I woke up at 3:15am with severe abdominal cramping, dizziness, excessive thirst, and nausea. The area around the injection site was swollen, red, and painful to touch. I fell over on my way to the toilet due to extreme dizziness. I had three hours of diarrhea, and then took pepto bismal and bennydryl. Those remedies worked and my symptoms subsided and I was able to fall back asleep by 4am. In the morning I felt normal, besides some remaining pain and redness surrounding the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/04/2021,2.0,PHM,"Synthroid 137mcg daily and Vitamin D 5,000IU daily",,Hypothyroidism/Hashimotos,,,"['Abdominal pain', 'Diarrhoea', 'Dizziness', 'Fall', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Nausea', 'Sleep disorder', 'Thirst']",1,MODERNA,IM 919503,WA,29.0,F,"rash, hives, anaphylaxis, throat tightening, felt out of body",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,WRK,Sertraline 100 mg PO QHS,none,"endometriosis, PCOS, asthma",HIVES-FLU VACCINE- 14 YEARS OLD,"Levofloxacin, shellfish, COVID-19 vaccine, Midazolam, Pseudoephedrine, watermelon","['Anaphylactic reaction', 'Computerised tomogram thorax', 'Electrocardiogram', 'Feeling abnormal', 'Full blood count', 'Rash', 'Throat tightness', 'Troponin', 'Urticaria']",1,PFIZER\BIONTECH,IM 919504,MT,54.0,M,"About an hour after being vaccinated, I got very pale, and almost had a syncope episode at work. I felt weak kneed for about 2 hours afterwards, and was still wobbly knees the next day. I also had muscle/joint aches the same day, which went away within 24 hours. In the past 6 days, I have had reoccurring headaches, fatigue, and this morning, had a severe enough headache to bring on nausea. I am med compliant with all my meds and I take care of my Type II diabetes, I am also a volunteer firefighter - advanced EMT, so I know when there is a problem.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,"Ibuprofen, Potassium Citrate, Metformin, ASA, Pramipexole, Omeprazole, Atorvastatin, Vitamin C, Vitamin D3, Zinc",None,"Type II Diabetes, High Cholesterol, Kidney stones",,Acetaminophen- makes me sick to my stomach and headache,"['Arthralgia', 'Blood glucose normal', 'Fatigue', 'Headache', 'Joint instability', 'Muscular weakness', 'Myalgia', 'Nausea', 'Pallor', 'Presyncope']",1,MODERNA,IM 919505,MI,37.0,F,"Patient developed tongue numbness, anxiety, stated that she felt her tongue was swelling up. RN and paramedic evaluated patient, VSS, tongue showed no signs of swelling, no acute signs of allergic reaction. Sat with patient for a few minutes, she calmed down and stated her tongue did not feel numb anymore. After waiting at clinic for 10 more minutes patient felt okay to go home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,,,"Asthma, Anxiety, hypothyroidism",,,"['Anxiety', 'Condition aggravated', 'Hypoaesthesia oral', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 919506,IL,49.0,F,"Started with pain at injection site the day after vaccine was given. The following day (2 days after vaccine), there was a quarter size bump and it was tender when touched. At one week, the site was no longer tender but still erythema surrounding injection site, slightly larger. At 2 weeks, noticed bump was more diffuse had spread (~4-5 cm) with more noticeable erythema around the edges. Contacted employee health at this time who advised me to contact my PCP and submit VAERS report. No fever or other systemic reactions during this period. Unsure if 2nd vaccine should be given.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/29/2020,9.0,PVT,"Women's multivitamin, Thera Tears Nutrition (omega-3 supplement).",no,chronic dry eye syndrome; no other health conditions,"Flu vaccine 10/2021, injection site reaction but more localized that current and gone within a few days of vaccine.","Azithromycin (hives), amoxicillin (rash), mastisol (rash)","['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,PFIZER\BIONTECH,IM 919507,UT,33.0,F,Mild rash with first dose of Pfizer-BioNTech COVID 19 vaccine. Evaluated in ED for rash. Gave diphenhydramine 25 mg PO and observed for 1 hour. Patient felt comfortable discharging and returning if symptoms worsened.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,,,,,Erythromycin,['Rash'],1,PFIZER\BIONTECH,IM 919508,IL,42.0,F,"Few minutes after receiving the vaccine I have noticed slight shortness of breath, then after 45 minutes, I developed a headache. These symptoms worsen as the day progressed. The severe headache and increased shortness of breath lasted 14 days along with dangerously elevated blood pressure, fatigue, and nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,"levoxyl 100mcg, Panteprazole 40 mg taken at 06:30am",none,"subacute thyroiditis, peptic ulcer disease",flu vaccine,"flu vaccine, oxycontin, Chloral hydrate,","['Blood pressure increased', 'Dyspnoea', 'Fatigue', 'Headache', 'Nausea', 'SARS-CoV-2 test negative', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 919509,RI,40.0,M,In December 24th late in the evening I experienced sweats followed by extreme chills for a few hours. I also had upset stomach and diarrhea throughout the day. All symptoms only lasted the day after injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,,,,,,"['Abdominal discomfort', 'Diarrhoea', 'Hyperhidrosis']",1,PFIZER\BIONTECH,SYR 919510,MA,30.0,F,The onset of symptoms started around 9:15am. I experienced numbness and tingling to bilateral feet and lower legs. I experienced dizziness. I also experienced an increased heart rate (160s-170s BPM). I was hyperventilating and had difficulty with breathing. I was pale and cold. I had uncontrollable shakes. My BP was a bit higher than my normal but not hypertensive. I was given candy and juice after onset of symptoms. ( I did have an English muffin prior to receiving the vaccine). My symptoms subsided for some time but then came back about 15 minutes later. These symptoms continued to occur about every 15 minutes for a period of close to 2 hours. I was given Benadryl 50mg PO after the first hour of symptoms. I continued to experience the symptoms for up to about 45 minutes after being given Benadryl. My symptoms began to subside and eventually stopped after the 2 hour mark.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,women's multivitamin,,Hx Atrial Septal Defect Repair in 1993. Resolved.,,,"['Dizziness', 'Dyspnoea', 'Feeling cold', 'Heart rate increased', 'Hypertension', 'Hyperventilation', 'Hypoaesthesia', 'Pallor', 'Paraesthesia', 'Tremor']",1,MODERNA,IM 919511,KY,43.0,F,"Diffuse pruritic rash beginning on DAY 6 post vaccine on chest/abdomen/back/legs/arms/sides of feet/wrists. Saw urgent care prescribed steroids, Benadryl, Vistaril, Zyrtec; also using Benadryl OTC cream Symptoms of pruritic so severe difficulty with working and sleeping Rash and itching is persistent",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/29/2020,6.0,PVT,Celebrex,None,Chronic back pain Ventral hernia from pregnancy,,Codeine Latex,"['Impaired work ability', 'Insomnia', 'Pruritus', 'Rash', 'Rash pruritic']",1,MODERNA,IM 919513,LA,52.0,F,"Severe dizziness, weakness, and loss of focus about 3 hours after injection and continuously for the last 24 hours so far.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,SEN,,,,,,"['Asthenia', 'Blood test', 'Disturbance in attention', 'Dizziness', 'Electrocardiogram', 'Magnetic resonance imaging', 'Urine analysis']",1,MODERNA,IM 919514,DE,49.0,F,"Tachycardia and flushing immediately after shot given, followed by fullness (slight swelling) in mouth, prickly feeling to tongue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,"Colchicine, folic acid, methotrexate, levothyroxine",,"Hypothyroidism, undifferentiated connective tissue disease",,"Ciprofloxacin, tequin","['Flushing', 'Immediate post-injection reaction', 'Mouth swelling', 'Paraesthesia', 'Paraesthesia oral', 'Tachycardia']",1,PFIZER\BIONTECH,IM 919516,CA,35.0,M,"Similar, milder version of diffuse urticaria rash developed lasting 10-14 days accompanied by several days of fatigue. This was similar reaction to that developed when I had covid 19 10/2020; however, much milder reaction. Rash is now healed/resolved on 1/4/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/23/2020,2.0,PVT,Zyrtec,None,Chronic allergic sinusitis,,"Clindamycin, omeprazole- rash","['Fatigue', 'Urticaria']",1,PFIZER\BIONTECH,SYR 919517,,45.0,F,"Diaphoresis, itchy throat. Patient has history of anaphylaxis. Received 0.3 mg epinephrine, no change in symptoms. Placed on 15L O2 via face mask. Received second dose of 0.3 mg epinephrine and 50 mg diphenhydramine. Transferred to Urgent Care, improved after transfer and was discharged to home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,fluoxetine sertraline albuterol,,depression anxiety GERD panic disorder asthma allergic rhinitis,,"sulfa, iodine, shellfish","['Hyperhidrosis', 'Throat irritation']",1,MODERNA, 919518,NV,59.0,F,"11:40 AM- Patient reported pain in the left shoulder. Redness and swelling were present around the vaccination site and into the left shoulder area. The redness progressed along the upper arm chest and neck area. The areas were warm to the touch. Patient reported a feeling of being 'hot.' No reported shortness of breath or itching. Patient was able to communicate and remained alert. Initial BP 153/85 P 80; Repeat BP 155/92. Benadryl 50 mg oral dose was given. Repeat BP at 12:05 PM 146/92 P 80. Patient was instructed to take Benadryl 50 mg PO every 4 hours as needed. She stated that she had Benadryl at home. She was given a work release for one day. She was instructed to call 911 if she experienced any further symptoms. Patient was called at 3:53 PM for followup. She reported that the redness was gone but she was sleepy from the Benadryl. She was instructed that if any further redness or swelling returns or severe symptoms, then she should take the Benadryl again and call emergency services.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Amlodipine, Hydrochlorothiazide, Thyroid, Albuterol, Aspirin 81 mg",None noted.,"Hypertension, Thyroid Disease, Increased clotting disorder",,Lisinopril; Seasonal Allergies,"['Erythema', 'Feeling hot', 'Impaired work ability', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Skin warm', 'Vaccination site swelling']",1,MODERNA,IM 919519,TN,80.0,F,Patient stood up and blood pressure dropped and started to faint and nursing staff was with her. Her blood pressure was 85/45 and pulse of 60. Patient got nauseated and vomited. Nursing staff contacted MD and they decided to have her checked out at the ER.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,SEN,Lisinopril,,"Parkinson's, unspecified dementia",,NKA,"['Blood pressure decreased', 'Nausea', 'Presyncope', 'Vomiting']",1,MODERNA,IM 919520,TX,49.0,F,"a day later after vaccine being administered, patient removed the band aid and notice a rash and swelling. Patient feels tingling and pain in the site. Patient was advised to take antihistamine and Ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,None,None,None,,None,"['Injection site pain', 'Injection site paraesthesia', 'Rash', 'Swelling']",1,MODERNA,IM 919521,MN,47.0,F,Initial 36 hours sore at injection site Day #4 pain in hip joints and moderate aching in legs bilaterally Day #5 prickling needles feeling soles of feet bilaterally and palms of hands for short time. Palms have resolved. Soles of feet remain on Day #6.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,PVT,Lyrica Catapres MVI Vitamin C Vitamin D,,RSD,,Iodine dye NSAIDS,"['Arthralgia', 'Injection site pain', 'Pain in extremity', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 919522,CO,21.0,M,"When reviewing forms with patient the patient disclosed a shellfish allergy. He described the symptoms of his skin turning red, shaking, and swelling in his throat as swelling in the past. He indicated that he had needed to use an epi pen in the past for his allergy. He still wanted the vaccination and knew we had an epi pen handy. He was given the vaccination in his left arm and was set up next to the staff development employee who was timing and monitoring patient's for symptoms. An epi pen was given to the monitor so it would be handy. The patient's right hand started shaking within a minute and it was hard to tell if it was from being anxious. Patient continued to communicate verbally and stated he wanted to use the epi pen. 911 was called by the staff and the staff member with the epi pen took it and the patient out of the main area. Paramedics transported him to the hospital with slight tachycardia and never did administer epi pen while in facility. Patient was always conscious and able to verbally communicate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,SEN,"Unknown, possibly cannabis",None disclosed,none reported,,shellfish,"['Anxiety', 'Tachycardia', 'Tremor']",1,PFIZER\BIONTECH,IM 919523,CA,42.0,F,"Shortly after leaving vaccine site tingling, slight numbness to left side of ace, and left feeling ""cold"".. Cheek flushed, tingling and numbness. numbness to tongue. Facial flushing resolved within 1 hour. Numbness-tingling resolved by morning of next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Feeling cold', 'Flushing', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Injection site paraesthesia', 'Paraesthesia']",1,MODERNA,IM 919524,TX,55.0,F,"Chills, headache, took two Tylenols. Headache starting pounding. Took more Tylenols, Got chills, pain in armpits, HR 116, O2 95%, Went to Hospital on Jan. 1. Had tachycardia, bp 140/110, slight fever, had just took Tylenol. Bloodwork came back fine. COVID test negative. was told to continue monitoring. Yesterday still had a temperature of 99. Today, feeling a little bit better.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PUB,Allergy meds,no,Asthma,flu vaccine slight fever,"Demarol, Flagyl","['COVID-19', 'Chills', 'Headache']",1,MODERNA,IM 919525,GA,51.0,F,"While injecting vaccine, syringe malfunctioned when spring action to retract the needle broke and cause a partial dose to enter patient and the rest leaked out of syringe. It is unknown how much vaccine patient received.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Syringe issue', 'Underdose']",1,PFIZER\BIONTECH,IM 919526,WA,35.0,F,"On 12/30/20, woke up with a swollen lymph node in right side of neck. Node appeared to increase in size from 12/30/20 to 1/4/20, causing increasing pain in swallowing. On morning of 1/4/20, presented to local ER due to increasing size and pain in neck/ear canal, as well as concerns it may be blocking esophagus.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,WRK,"Advair, ProAir, Wellbutrin, Nuvaring, multivitamin, glucosamine, fish oil, calcium",,Chronic asthma,,"eurythromiacin, animal dander, mold, pollen","['Blood test', 'Computerised tomogram', 'Lymphadenopathy', 'Odynophagia']",1,PFIZER\BIONTECH,IM 919527,UT,42.0,F,"Shortness of breath and tremors with Pfizer-BioNTech covid-19 vaccine 25 minutes after 0.3 mL IM for right deltoid after first dose. Hemodynamically stable and afebrile. Differential diagnosis includes but is not limited to allergic reaction, anxiety, panic attack, asthma attack, sequelae of hyperthyroidism. After resting comfortably in the room for approximately 15 minutes, she reported that her symptoms were starting to subside. She happily excepted diphenhydramine (dose not documented). She was observed for 2.5 hours and had no worsening of symptoms. Her vital signs were stable and she had appropriate SPO2 on room air throughout her stay in the emergency department. We discussed strict return precautions for evidence of allergic reaction, chest pain, worsening shortness of breath, altered mental status or fever. She will follow-up with her primary care doctor. Discharged in stable condition to the care of her husband.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,Panic attacks and anxiety; hyperthyroidism,,"Latex, lamotrigine, vortioxetine","['Anxiety', 'Asthma', 'Dyspnoea', 'Hypersensitivity', 'Hyperthyroidism', 'Panic attack', 'Tremor']",1,PFIZER\BIONTECH,IM 919528,CA,35.0,F,"PT ADVISED NOT TO HAVE 2ND DOSE OF COVID VACCINE AND TO OBTAIN ALLERGY CONSULT. At 12:05pm, pt got itching in her throat and 25mg of benadryl was given. At 12:08pm, another 25mg of benadryl was given based on weight-based dosing. Pt is drowsy and we recommended that she does not return to work b/c she was given 50mg benadryl. After 40 minutes, pt very drowsy but still has itchy throat, seems to be better. However, after the flu shot, her throat was itchy for the whole day after given 50mg benadryl. Consulted Dr who recommended we observe her for a total of 2 hours. Advised her to get an allergy consult since she has had this reaction to 2 vaccines and that she does not receive the 2nd dose of COVID vaccine unless advised by allergist. Pt verbalized understanding that she will not receive 2nd dose unless advised by allergist. Pt left at 1:35pm as she had sick child at home. Pt understands to seek medical attention if symptoms worsen. No additional reactions noted in EMR",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,,,,"Flu vaccine, additional details unknown","after the flu shot, her throat was itchy",['Throat irritation'],1,MODERNA,IM 919529,CA,46.0,M,Sweating profusely and mild fatigue since injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,WRK,"Patient report taking medication for heartburn, Omeprazole 40 MG",,,,,"['Fatigue', 'Hyperhidrosis']",UNK,PFIZER\BIONTECH, 919530,NJ,28.0,F,Large rash on injection arm started 6 days post vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,01/02/2021,32.0,WRK,Sprintec (Norgestimate and ethinyl estradiol .250 mg/.035 mg,None,None,,None,['Rash'],1,MODERNA,IM 919532,CO,36.0,F,Sunday started with severe headache and continued with mild body aches and feeling of just being tired but didn't change my day much. Woke Monday morning at 4am to get ready for the work and the room was spinning. Off and on for the next 4 or so hours my blood pressure dropped and I had to lay back down. Even laying down had the room spinning. It has not been consistent and has improved as the day has gone but has yet to go away.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PVT,None,None,ANA blood test - but no definitive diagnosis,,Codiene,"['Blood pressure decreased', 'Fatigue', 'Headache', 'Pain', 'Vertigo']",1,PFIZER\BIONTECH,SYR 919535,OH,43.0,F,"Moderna COVID-19 Vaccine: One week after receiving first dose, patient experienced onset of redness, warmth, swelling and mild itching at injection site. Redness started approx. inch in diameter and spread to approx. 5 inches at time of reporting. No treatment was given as there was little to no discomforted associated and no other symptoms. Patient is an RN and is attempting to seek counsel from allergy/immunology department on safety of receiving second dose in the series.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/03/2021,7.0,WRK,"Vitamin D, Biotin, Multivitamin",None,mild exercise-induced asthma,,"Sulfa - Rash, Flagyl - rash, Yaz - rash","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 919536,TX,42.0,F,Sore arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,SCH,"Calcitriol, Losartan, Furosemide, Iron polymaltose.",No,CKD stage 4,,No,['Pain in extremity'],UNK,PFIZER\BIONTECH,SYR 919537,MN,96.0,F,Resident exhibited no adverse events during 30 minute monitoring following vaccine administration. Resident found without pulse at 1900.,Yes,01/03/2021,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,SEN,Robitussin Cough+Chest Cong DM Liquid 5-100 MG/5ML (Dextromethorphan-guaiFENesin) Tylenol Extra Strength Tablet (Acetaminophen) amLODIPine Besylate Tablet 5 MG Morphine Solu Tab 2.5MG Capsaicin Cream 0.025 % Leflunomide Tablet 10 MG Levothy,Resident had suspected vasovagal episode with drop in O2 saturation.,"ACUTE ON CHRONIC DIASTOLIC (CONGESTIVE) HEART FAILURE RHEUMATOID ARTHRITIS, UNSPECIFIED ANEMIA, UNSPECIFIED HYPOTHYROIDISM, UNSPECIFIED CACHEXIA ESSENTIAL (PRIMARY) HYPERTENSION DEMENTIA IN OTHER DISEASES CLASSIFIED ELSEWHERE WITHOUT BEHAVIORAL DISTURBANCE AGE-RELATED PHYSICAL DEBILITY OTHER CHRONIC PAIN DILATED CARDIOMYOPATHY ERYTHEMATOUS CONDITION, UNSPECIFIED UNSPECIFIED OSTEOARTHRITIS, UNSPECIFIED SITE PRIMARY GENERALIZED (OSTEO)ARTHRITIS OTHER SPONDYLOSIS WITH RADICULOPATHY, LUMBAR REGION HYPERKALEMIA OTHER INTERVERTEBRAL DISC DEGENERATION, LUMBAR REGION AGE-RELATED OSTEOPOROSIS WITHOUT CURRENT PATHOLOGICAL FRACTURE CERVICALGIA OTHER BIOMECHANICAL LESIONS OF LUMBAR REGION ��� BILATERAL PRIMARY OSTEOARTHRITIS OF KNEE LOCALIZED EDEMA HYPO-OSMOLALITY AND HYPONATREMIA OTHER SPECIFIED DISORDERS OF BONE DENSITY AND STRUCTURE, UNSPECIFIED SITE HISTORY OF FALLING WEAKNESS",,Celebrex and Tramadol,['Pulse absent'],1,MODERNA,IM 919538,IL,56.0,F,"After I got the vaccine around 30 minutes later I started to feel a headache and pain on my face was not to bad and I tought is a normal symptom but the pain and swelling an my face is increasing every day, even my teeth hurts and I'm taking Gabapentin 100MG 3 times a day. I am not sure if the vaccine components triggered my Trigeminal Neuralgia and if it's okay to get the second dose, I will see my Dr. tomorrow 01/05/21",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,OTH,Pantoprazole 40MG twice a day for the stomach. Claritin 10MG once a day for allergies,no,"Trigeminal neuralgia, asthma, migraine headache,",,Carbomazepin medicine and pet fur,"['Facial pain', 'Headache', 'Swelling face', 'Toothache']",UNK,PFIZER\BIONTECH, 919539,FL,31.0,F,"developed dizziness, headache, body aches, chills, nausea, and diarrhea that lasted from late Friday night 1/1/21 to 1/2/21, then experienced mild headache and body aches on 1/3/21. Symptoms resolved 1/4/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/01/2021,4.0,WRK,"birth control, multivitamin, omega 3, xyzal, Flonase as needed, immune support multivitamin powder",,,,"Zyrtec- dizziness, nickel- rash, seasonal allergies","['Chills', 'Diarrhoea', 'Dizziness', 'Headache', 'Nausea', 'Pain', 'SARS-CoV-2 test negative']",1,MODERNA,IM 919540,NY,49.0,F,"Arm soreness, low grade fever, chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,None,,,,NKDA,"['Chills', 'Fatigue', 'Limb discomfort', 'Pyrexia']",1,MODERNA,SYR 919541,SD,32.0,F,"Patient presented for Covid-19 vaccine clinic. She did report a previous reaction to influenza vaccine, but she premedicated with benadryl for that. She did not premedicate for covid vaccine. Approximately 20 minutes after her vaccination, she was observed in the post vaccine waiting area and stated that she was a bit dizzy and tickling in her throat. In addition, she had an itchy rash on her left forearm, the side in which her vaccine was given. She was escorted to the nearest exam room. There, she began to have nearly non-stop coughing to the point of gagging. She was given epi 0.3mg im with some improvement of symptoms. Continuous monitoring showed oxygen sats in the upper 90s, BP was in the 150s systolically. She was given 50 mg of Benadryl orally. At that point, patient was taken to the procedure room via wheelchair. After approximately 30 minutes, the ticking sensation in the throat returned and patient was having more difficulty breathing. Another epi 0.3mg im was given, along with pecid 40 mg po. 125 mg of Solumedrol was given IV, with saline lock left in place. After 20 minutes, patient again was having difficulty. Another epi 0.3mg was given and EMS activated. While awaiting EMS, an albuterol neb was given. EMS activated ALS. Patient left facility in stable condition, transported to hospital. Pt received another 0.3mg of epi im enroute to hospital. Pt was in good condition at hospital and discharged to home. Pt returned to ER the following day with c/o cough, neb and prednisone given and discharged home. Pt returned to ER again on 1/2/21 with c/o elevated BP 170/80's. Pt presented to clinic on 1/4/21 with continued elevated bp 170/110, and shortness of breath.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,none,none,anxiety,"influenza vaccine causes throat itching, premedicates with Benadryl","bee stings, flu vaccines","['Blood pressure increased', 'Cough', 'Dizziness', 'Dyspnoea', 'Rash', 'Rash pruritic', 'Retching', 'Throat irritation']",2,MODERNA,IM 919542,CA,53.0,F,Pt states she has tingling in both upper and lower extremities and a thickening feeling in her tongue. Pt given 10mg cetirizine. Pt observed for 30 minutes. Pt states feeling are resolved. Pt released to work.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Benadryl,,,,,"['Paraesthesia', 'Tongue disorder']",1,PFIZER\BIONTECH,IM 919543,MI,37.0,F,"Allergic reaction: after 10-15 min, got hives on arms and face, felt dizzy, fast heart rate (116), rigors. The urgent response team started iv fluid 1L, gave solumedrol (IV) and Benadryl (IM). Paramedics transferred me to ER (which was downstairs in hospital). After 1 hour the hives faded and gone by 2h. They kept me for observation for 5h. I did not have any difficulty breathing, did not receive Epi.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,OCP,None known,None,,"Cosmetics, some wines (sulfites), dust, cats, horses","['Chills', 'Dizziness', 'Heart rate increased', 'Urticaria']",1,PFIZER\BIONTECH,IM 919544,IN,40.0,F,"25 hours after receiving the vaccine I developed a stomach ache. I had stomach cramps and felt nauseous. I didn't experience any diarrhea or vomiting that night. The stomach cramps were enough to keep me up for most of the night, but not as bad as food poisoning. The next morning when I got out of bed I immediately got sick and vomited. I was very shaky and light headed. These symptoms continued until about 7 pm on the 30th.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/29/2020,28.0,SEN,Omeprazole IB Profen Xytal,None,Migraines,,None,"['Abdominal pain upper', 'Dizziness', 'Nausea', 'Nervousness', 'Sleep disorder', 'Vomiting']",UNK,MODERNA,SYR 919545,CA,51.0,F,"7pm the same night experienced chills 8-9pm that night body aches, joint pain, hot feeling with no fever Whole day Sunday: severe joint pain, body aches, and headache Lasted until today. Only symptom today is joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,UNK,,,,,,"['Arthralgia', 'Chills', 'Feeling hot', 'Headache', 'Pain']",1,MODERNA,SYR 919546,AL,51.0,F,"thrombotic stroke -necessitating hospitalization; and craniotomy; required mechanical ventilator for 2 days. Patient now extubated, breathing on her own. Patient remains hospitalized with marked deficits (aphasic)",Not Reported,,Yes,Yes,3.0,Yes,N,12/29/2020,01/01/2021,3.0,PVT,Plaquenil Fioricet Midrin,PMH- Lupus; HTN; marked hyperlipidemia,Lupus Hypertension Hyperlipidemia,,None listed,"['Antinuclear antibody positive', 'Antiphospholipid antibodies', 'Aphasia', 'Blood cholesterol increased', 'Blood homocysteine', 'Coagulation time', 'Craniotomy', 'Low density lipoprotein increased', 'Mechanical ventilation', 'Thrombotic stroke']",1,MODERNA,IM 919547,CA,50.0,M,"12/30/2020, onset s/s runny nose, dry cough, itchy, watery eyes. Inner elbow flushing similar to taking niacin, Most notably headache and low back pain. Both knees hurt, tight stomach and malaise.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,,,,,,"['Abdominal discomfort', 'Arthralgia', 'Back pain', 'Cough', 'Eye pruritus', 'Flushing', 'Headache', 'Lacrimation increased', 'Malaise', 'Rhinorrhoea']",1,MODERNA,IM 919548,WA,19.0,F,"Day 1: pain/swelling at injection site with redness, muscle aches, joint pain Day 2: pain/swelling at injection site with redness, muscle aches, joint pain, headache; worked but with considerable discomfort/strain Day 3: pain at injection site, muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia; unable to work Day 4: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, diarrhea; unable to work; attempted to see doctor but was refused care due to ""CoVid-like symptoms"" Day 5: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, diarrhea; unable to work Day 6: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, nausea; unable to work; attempted to see care at Urgent Care but was turned away for having ""CoVid-like symptoms;"" went to hospital per the recommendation of MD and urgent care Day 7: mild muscle aches, fatigue, feeling unwell, insomnia, sweating, sore throat; unable to work Day 8: sore throat, mild fatigue, sweating; unable to work",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,SEN,NO,None,None,,No,"['Arthralgia', 'Chills', 'Diarrhoea', 'Discomfort', 'Fatigue', 'Full blood count', 'Headache', 'Hyperhidrosis', 'Impaired work ability', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Insomnia', 'Malaise', 'Mononucleosis heterophile test', 'Muscle strain', 'Myalgia', 'Oropharyngeal pain', 'Pyrexia', 'SARS-CoV-2 test', 'Streptococcus test', 'Urine analysis']",1,PFIZER\BIONTECH,IM 919551,WI,60.0,F,Hives,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,Sinusitis,,Hive age 21. Tetenus,,['Urticaria'],UNK,PFIZER\BIONTECH, 919552,VA,36.0,F,- At time of vaccine (8:30am) no soreness or reaction. - Approximately 6pm injection site became sore and mild body aches and chills noted. Temperature 99.1; 2 Tylenol taken. - 1/3/2021 Approximately 12am woke up with severe chills and body aches. Temperature 101.5; 2 Advil taken. - Approximately 8am decreased body aches/chills. Temperature down to 98.8; 2 Advil taken. -Approximately 4pm mile-moderate body aches and chills. Temperature 101.8; 2 Advil taken. - Approximately 5:15pm Temperature 101.1 - Approximately 6:30pm Temperature 99.8; 1 Tylenol taken. - Approximately 7:30pm Temperature 98.6 - Approximately 8:30pm Temperature 97.8 - Approximately 10pm Temperature 96.6; 2 Advil taken. - 1/4/21 approximately 7:15am Temperature 96.6; no chills or body aches; injection sight remains slightly tender.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,OTH,Nortriptyline HCL 10 MG,,Migraine,,,"['Body temperature increased', 'Chills', 'Injection site pain', 'Pain']",1,MODERNA,IM 919553,NC,52.0,F,"Initially I had sore arm and very tired , which all resolved with in 24 hours of the vaccine. The morning of the 26th (day 3 after vaccine) , I woke up and felt great.. I took my normal 4- 5 mile run. I felt a little dizzy , & hungry when I ran (not my normal) , got home had diarrhea 1 x , then for next two days very faint GI discomfort and I had fever for two days , temp range 99-100",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/26/2020,3.0,WRK,"Vit D, Vit C, psylium husk",,,,tramadol,"['Abdominal discomfort', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Hunger', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 919554,CA,42.0,F,stiffness in arm headache at the base of the skull tingly headache at the front of the skull feels heavy,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Discomfort', 'Headache', 'Musculoskeletal stiffness', 'Paraesthesia']",1,MODERNA,SYR 919555,WA,64.0,F,"The person who gave me the shot placed the injection too low on my arm. It should have been up near the shoulder, but instead the person gave it to me down toward the middle of my arm. I knew something was wrong immediately because it felt so warm and disruptive. The doctor on the scene said it was nothing. Nine days later I went to Urgent Care with swelling, hot-to-the-touch, itchy and a huge knot. The Urgent Care Dr. gave me a five-day prescription for Prednisone and also gave me a prescription for hydroXYzine pamoate, which is an antihistimine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,"Hydrochlorothiazide, Vitamin B, Vitamin D, Calcium Supplement, Medical Cannabis",None,Fibromyalgia,,Augmentin,"['Feeling abnormal', 'Nodule', 'Product administered at inappropriate site', 'Pruritus', 'Skin warm', 'Swelling']",UNK,MODERNA,SYR 919556,IN,30.0,F,"I had a sore arm the first couple of days, on the 22nd I had chills sore throat headache congestion sneezing sniffling and low grade fever 99.6. on the 23rd loose stools nasal drainage, I called the hospital hotline and I had to be off for ten days and went to Urgent care and took a rapid test and the test was positive. I have been quarantined for 14 days . The 25th was probably the worst day the 26th was a little better. the 27th symptoms were more mild and I also had diarrhea The 28th I woke up with a headache and light sniffles and the 27th I had no symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/22/2020,3.0,PVT,"buspar, lamictal, wellbutrin, metoprolol, L- methylfolate, synthroid. valboltoa birth control, allegra, zyrtec",no,anxiety and depression,,"sulfa, erythromycin,","['COVID-19', 'Chills', 'Diarrhoea', 'Headache', 'Impaired work ability', 'Oropharyngeal pain', 'Pain in extremity', 'Pyrexia', 'Respiratory tract congestion', 'Rhinorrhoea', 'SARS-CoV-2 test positive', 'Sneezing']",1,PFIZER\BIONTECH,SYR 919557,NE,86.0,F,"Patient reported tightness in throat, lightheadedness, and cough after the 15 minute observation period. Patient was given Benadryl and symptoms improved in 15-20 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,none,"['Cough', 'Dizziness', 'Throat tightness']",1,PFIZER\BIONTECH,IM 919558,,64.0,F,Developed dyspnea after vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,"oxycodone, estradiol, diclofenac, misc vitamins, some herbal products, whey powder",,"migraine, asthma, irritable bowel syndrome, breast implant, gluten intolerance, osteoporosis",,H/O side effects from centrally-acting and GI medications.,['Dyspnoea'],1,MODERNA, 919559,OR,40.0,F,"Pt experienced nausea, shortness of breath, chest tightness and anxiety and then lost consciousness. Vitals were obtained several times during the medical intervention. Respirations were within normal limits throughout, BP was 135/89 initially, then rose to 210/110, then declined to 180s/? prior to EMS assuming care. Heart rate was 47 initially, then rose to normal limits. Treated with epinephrine, Benadryl and ammonia smelling salts and transported by ambulance to hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,unknown,unknown,unknown,,unknown,"['Anxiety', 'Blood pressure increased', 'Chest discomfort', 'Dyspnoea', 'Heart rate decreased', 'Loss of consciousness', 'Nausea']",1,MODERNA,IM 919560,CA,48.0,F,"Clinic staff was notified that a patient was having a reaction to the Moderna vaccine that was administered today at 843AM. Her reaction started around 855AM. She described her reaction to be tingling and numbing of her shoulders and described it as ""it feel like it fell asleep"" noted the injection site to be appropriate. The patient was asked to stay for additional 15 minutes. She didn't feel any difference after the additional 15-minute observation. The patient was able to tolerate the reaction and was asked to observe if it gets worse. Patient was also recommended to call Occ Health if it gets worse for proper triaging. Per reporter, resolved day following vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,WRK,Meloxicam,,,,"Hydromorphone, adhesive","['Hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 919561,,22.0,F,"Chills and headache. BP 107/67, 96 OSat, supine positioning. Resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Chills', 'Headache']",1,MODERNA,SYR 919562,NY,30.0,F,"4 hours after fatigue and body aches 10 hours after fever, chills, arm pain, body aches, headache 1 week redness and rash at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,OTH,Multi vitamins Errin birth cjntrol,,,,NKDA,"['Chills', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site rash', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 919564,CA,47.0,F,EE presented to EH with c/o hives to face and racing heart rate at 1445,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Metoprolol 25 mg,,Tachycardia and hx of blood clots to L and R lung. Stress hives,,Mangoes and Ibuprofen,"['Erythema', 'Flushing', 'Heart rate increased', 'Swelling', 'Urticaria']",1,PFIZER\BIONTECH,IM 919565,TX,43.0,F,"My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but I didnt and took benedryl went to sleep, woke up and I felt a little SOB but more like something was tied around my ribs preventing me from breathing. I saw the cardiologist who believed it to be sinus tackycardia as a result as an AE to vaccine. Felt as if my face and lips were swelling so I took benedry and laid down again and the next morning when I woke up and my face and lips were super swollen. But by the 3rd day the symptoms began to subside a little. By the 24th my HR had balanced out and I only had residual swelling around the eye area.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,"Vit D, B12, multivitamin",no,no,,"taxotere, cats","['Chest discomfort', 'Dyspnoea', 'Electrocardiogram', 'Lip swelling', 'Pain in extremity', 'Periorbital swelling', 'Sinus tachycardia', 'Swelling face', 'Vaccination complication']",1,PFIZER\BIONTECH,IM 919566,CO,38.0,F,"Injection site became red, very warm to the touch, and swollen. Lasted about 36 hours, then resolved. No other symptoms, only localized reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/01/2021,8.0,PVT,none,none,none,,none,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Skin reaction']",1,MODERNA,IM 919567,MD,65.0,F,"Headache, Sore throat gradually increasing over the past 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,MIL,Premarin Synthroid,,Hashimoto's Thyroiditis Retinitis Pigmentosa,,,"['Headache', 'Oropharyngeal pain']",1,PFIZER\BIONTECH,IM 919568,DC,33.0,F,"Swelling at injection site, site is warm to the touch and began swelling/soreness at Day 6 post vaccine administration",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,OTH,,,,,"PCN, amoxicillin, latex","['Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 919569,CA,,F,"Patient received the covid vaccine on 12/20/2020. She tolerated the vaccine without problem. c/o new onset of stomach pain, diarrhea, nausea, and bodyache starting on 1/3/2021. Symptoms persist today. No diarrhea today, 1/14/2021. LMP - 10/2020. Denies fever, cough, HA, any ocular symptom. Covid test on 12/28/2020 was negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,01/03/2021,14.0,UNK,,,,,,"['Abdominal pain upper', 'Diarrhoea', 'Nausea', 'Pain', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH, 919570,WY,41.0,F,The next day on 12/19 I was super sore. On 12/20 really bad joint pain and I had rash located on my face and chest. I went to PCP on 12/21 seen PCP given EpiPen.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PUB,No,No,No,,MMR age 4 exp swelling,"['Arthralgia', 'Pain', 'Rash']",1,PFIZER\BIONTECH, 919571,IL,36.0,F,"Individual received the vaccine at 3:57 pm and at 4:15 pm pt report she was hot, her heart was racing, she felt flushed. She was given Pepcid 20mg by mouth and Benadryl 25 mg by mouth and monitored at the hospital vaccination site. Vital signs remained stable throughout. By 4:54 pm patient's flushing had resolved and pt reported feeling back to base line.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2020,01/04/2020,0.0,PVT,None,None,None,,None,"['Feeling hot', 'Flushing', 'Palpitations']",1,MODERNA,IM 919572,OH,31.0,F,Large raised red circular welt that?s lasted two weeks from vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/25/2020,2.0,PVT,Multivitamin,None,Asthma and migraines,,"Latex, cephalosporins","['Erythema', 'Swelling', 'Urticaria']",UNK,MODERNA,SYR 919573,CA,41.0,M,"itch, hard to swallow. throat tightness within few minutes of vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/18/2020,0.0,UNK,,,,,low class II IgE to peanuts and tree nuts. omnipaque (Iohexol),"['Dysphagia', 'Pruritus', 'Throat tightness']",UNK,PFIZER\BIONTECH, 919574,IL,47.0,F,"Didn't feel ""right"", felt like her throat was closing, couldn't swallow, shortness of breathe, breathing got worse, called 911, 1 Epipen given, she started to cough and talk to us, then couldn't breathe again, couldn't talk, paramedics arrived.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,SEN,,,,,,"['Aphasia', 'Cough', 'Dysphagia', 'Dyspnoea', 'Feeling abnormal', 'Throat tightness']",1,PFIZER\BIONTECH,IM 919575,WY,67.0,F,"Beginning the day after, pt had mild bruising over injection site. Over the next several days, bruising darkened and extended from superior L shoulder to elbow.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,"Metformin, insulin, Tylenol",Anemia,Diabetes Mellitus,,No,['Injection site bruising'],1,PFIZER\BIONTECH,IM 919576,AZ,28.0,F,Patient developed asymptomatic COVID-19 infection approximately three days after first dose of vaccine. Detected on serial testing of nursing home staff.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/21/2020,3.0,SEN,None,None,None,,None,"['Asymptomatic COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 919577,,60.0,M,"Patient reports Swelling of arm of injection site, induration, redness and itchiness at site.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,12/31/2020,7.0,WRK,"Blood Pressure, Lipitor",,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Peripheral swelling']",UNK,MODERNA, 919578,FL,89.0,F,"Swelling of eyes, lip numbness, tingling and dryness. Dizzy and weak. Client received Benadryl and was transported to hospital via EMS.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PUB,,,,,,"['Asthenia', 'Dizziness', 'Eye swelling', 'Hypoaesthesia oral', 'Lip dry', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 919579,,34.0,F,light headedness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,NKA,['Dizziness'],1,MODERNA,IM 919583,CO,76.0,F,"Tingling of tongue, lips, nose and cheeks lasted 5 hours . No swelling Unusual taste in mouth lasted only 5 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"amlodipine 10 mg, Aspirin 81mg, atorvastatin 20mg, Vitamin D3 2000iu, CoQ-10 200mg, estradiol 0.5mg every other day, losartan 100mg, magnesium 200 mg, miralax q hs, timolol 0.5% OS bid, latanaprost 0.005% OS hs, vyzulta 0.024% OS hs.",High blood pressure/ Celiac Disease/Glaucoma OS/,,,Gluten....celiac disease/ Amoxicillin...diarrhea/Dorzolamide eye drops...tingling sensation of face/ lovastatin....muscle aches Morphine...rash,"['Dysgeusia', 'Paraesthesia', 'Paraesthesia oral']",2,MODERNA,IM 919584,,48.0,F,"Lightheadedness, throat tightness. Increasing chest tightness. History of atrial fibrillation and bilateral breast implants. Received two doses of epinephrine and one dose of diphenhydramine.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,none,,none,,azithromycin,"['Chest discomfort', 'Dizziness', 'Throat tightness']",1,MODERNA, 919586,CA,55.0,F,"5 days after 1st vaccine, experienced sync opal event at home. .Arrived at work 12/28/2020 feeling slightly lightheaded and tachy. went home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/27/2020,5.0,PVT,,,,,,"['Dizziness', 'Impaired work ability', 'Syncope', 'Tachycardia']",1,PFIZER\BIONTECH,IM 919587,TX,39.0,F,"Body aches, chills and fever from around 8:30 pm 12/24/20 until around 10:00 am on 12/25/20. Injection site pain for 3 days. Fatigue for 48 hours after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,None,None,None,,Tetracycline,"['Chills', 'Fatigue', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 919588,FL,36.0,F,"Chief complaint of dryness of her tongue. Felt better after drinking Gatorade. Observed for 30 Min, no issues.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PUB,,,,,,['Tongue dry'],1,PFIZER\BIONTECH,IM 919589,AZ,62.0,F,Developed symptomatic COVID+ infection approximately four days after vaccine dose. Had confirmed exposure to COVID+ individual prior to vaccination. Was administered IV Bamlanivimab on 12/22/2020 at Hospital. Stayed in an isolation facility at Center for 9 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/22/2020,4.0,SEN,Levothyroxine Metformin Amitryptiline Aspirin Atorvastatin Cholecalciferol Cetirizine Sumatriptan Lisinopril,None,Diabetes Mellitus Type 2 Hypothyroidism Hypertension Migraine Headaches,,None,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 919590,CA,58.0,M,"About 2 minutes after receiving vaccine the individual reported feeling light headed. He also described an uncomfortable tingling sensation in his throat. Blood pressure had been normal prior to vaccination and became elevated. After about 30 minutes of persistent reaction, one dose of epi-pen (generic) was given. About 3 minutes after receiving the epinephrine he felt safe to stand up and more to a more comfortable chair. Lightheadedness, throat sensation, and elevated blood pressure resolved. He stayed another 15 minutes for observation and has no return of symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,unknown,unknown,unknown,,unknown,"['Blood pressure increased', 'Dizziness', 'Pharyngeal paraesthesia']",1,MODERNA,IM 919591,TX,34.0,F,"On the 16 early in the morning I woke up with a circular, itchy, warm, red rash. I went to Employee Health and was prescribed a steroid but I didnt take it and benedryl and claritin. I took claritin and benedryl for about 2 days which began to make the rash subside on the 18 but on the 23rd the rash reappeared and went back to EH and was given another round of steroids which I did in fact take this time. And after the 6th day of the steroid pack the rash has mostly resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/15/2020,12/16/2020,1.0,PVT,Birth Control Pill,no,no,,"Sulfur, penicillin","['Rash erythematous', 'Rash pruritic', 'Skin warm']",1,PFIZER\BIONTECH,IM 919592,,28.0,M,Puffy lips the night of injection went away after taking benadryl Sore throat which began a few hours after injection--still present Headache which began a few hours after injection--not sure if this is a migraine or side effect Soreness at injection site--stopped today (1/4/21),Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,Candesartan 4 mg tablet PO QHS Finasteride 1 mg tablet PO QAM Mirtazapine 15 mg tablet PO QHS Rizatriptan 10 mg tablet PO PRN Trazodone 200 mg PO QHS Omepreazone 40 mg capsule PO QAM Ajovy autoinjector every 30 days Gabapentin 100 mg caps,,"Migraines, anxiety & depression, chronic nausea",,"Cats, pollen, hay fever, dust","['Headache', 'Injection site pain', 'Lip swelling', 'Oropharyngeal pain', 'SARS-CoV-2 test']",1,MODERNA,IM 919593,IA,64.0,M,"Patient developed a septic knee (history of arthroplasty) need for immediate surgery, hospitalization and months to years of antibiotics in his future now.",Not Reported,,Yes,Yes,,Not Reported,N,12/30/2020,01/02/2021,3.0,UNK,,none,"hypertension, sleep apnea, osteoarthritis",,opioids,"['Arthritis bacterial', 'Culture wound positive']",1,MODERNA, 919596,CA,68.0,F,"Waves of quite severe malaise, abnormal neurological sensations in limbs, flushing, with start of rash versus hives, all starting 15minutes post infection. Relieved by Benadryl 50mg, which I brought with me. Took one hour to clear the initial wave of moderately severe malaise. Starting three hours later, extremely tired. Temperature 99 .5 my temperature runs low, went to bed. Next morning, temperature 100.5, didn?t feel well. Temperature rose to 102.5 in the afternoon. Regular Extra strength Tylenol brought it below 101. Extreme headache! interfered with function, lasted 3 days, severe day 1&2, milder day 3. Queasy with No appetite x 2 days. Day two after vaccine fever peaked at 101.5. Day three after vaccine, temperature peaked at 99.4 Day four very tired Day five entirely normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Atenolol 12.5mg,None,"Hyper cholesterolemia Vascular endothelial disorder, well controlled on atenolol.",,Septra caused near Anaphylaxis Cipro causes tendinitis,"['Decreased appetite', 'Fatigue', 'Flushing', 'Headache', 'Malaise', 'Nausea', 'Neurological symptom', 'Pyrexia', 'Rash', 'Urticaria']",1,MODERNA,IM 919597,PA,47.0,F,"I felt like passing out tunnel vision . everything was black except center of vision. Unable to focus or stay attentive while driving ""zoned out"" multiple times. Felt like my head was detached from my body unable to shake it for 2 and a half days.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,01/07/2021,12.0,PVT,Lamictal,Na,Na,,Sulfa,"['Dizziness', 'Feeling abnormal', 'Tunnel vision', 'Vision blurred', 'Visual impairment']",1,MODERNA,IM 919598,,39.0,F,tingling of the mouth,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,erythromycin,['Paraesthesia oral'],1,MODERNA,IM 919599,IA,40.0,F,"Reports paresthesias and subjective sense of ""numbess"" of R lateral neck, face, R ear and temporal area of scalp within 30 min of vaccine that persisted x 90 min. Also reported transient ""numbness"" of R anterior thigh that resolved spontaneously after 30 min. No pruritic, urticaria, rash. No mucus membrane symptoms - no conjunctivitis, rhinitis or oral/perioral symptoms. No mucosal swelling or sense of swelling. No respiratory symptoms. No presyncopal symptoms. Vitals: BP 134/87, Pulse 103, sats 100%.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,Seasonal allergies only No medication allergies,"['Hypoaesthesia', 'Paraesthesia', 'Paraesthesia ear']",1,PFIZER\BIONTECH,IM 919600,OR,49.0,F,"Very sore arm, required Tylenol Moderate fatigue Sore are resolved next day Fatigue continues",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,WRK,None,None,"Celiac IBS Raynauds Low BP GAD, Depression",,Gluten Dairy,"['Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 919601,CO,73.0,M,"severe chills, joint aches , confusion, Next day, 1/1/21, fully recovered with no side effects",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"COQ10, one-a-day, One a day vitamin Hydrochlorot - 12.5 mg Omeprasole - 20 mg atyorvastin - 40 mg Nifedipine Travatan Z - one drop each eye",NONE,None,,none,"['Arthralgia', 'Chills', 'Confusional state']",UNK,MODERNA,IM 919602,RI,55.0,F,"Stated she felt ""light-headed"" @ 1805. Denies being ""light-headed"" before vaccination. States that she felt the same way after she received her influenza vaccine this year. This nurse assisted Ee on bed in clinic for 15 mins. State she felt better @ 1830. Left observation @ 1830. V/S BP-122/76, P-56, O2-98.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 919603,TX,29.0,F,"Sore throat started yesterday, body aches, headache, fatigue, no fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,WRK,no,no,no,,no,"['Fatigue', 'Headache', 'Oropharyngeal pain', 'Pain']",1,MODERNA,IM 919604,MS,30.0,F,"Presented to the ED after developing chest tightness, cough, lightheadedness, and throat closing sensation. She received the Moderna COVID-19 vaccine on the morning of presentation. Within 15 minutes of receiving the vaccine she developed pain and numbness, starting at the injection site traveling down the ulnar aspect of her arm, and nausea. Over the next several hours she continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She took PO Benadryl 25mg; however, her symptoms were not alleviated. She was subsequently evaluated in the ED. � Received PO Benadryl 25mg, IV Benadryl 25mg, Epinephrine 0.3mg x 2, IV Famotidine 20mg, IV Solumedrol 125mg & 60mg, DuoNebs x 3, Racepinephrine x 1.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Amitriptyline 25 mg PO QHS Bupropion XL 150 mg PO Daily Cyanocobalamin 1000 mcg PO once weekly Ferrous sulfate DR 324 mg PO Daily Levothyroxine 100 mcg PO Daily Methocarbamol 500 mg PO TID prn muscle spasms Scopolamine 1.5 mg patch transder,,Anemia Asthma Depression Hypothyroidism secondary to thyroid cancer s/p thyroidectomy Hypertension Migraines Vertigo,,No known allergies,"['Alanine aminotransferase normal', 'Anion gap decreased', 'Aspartate aminotransferase normal', 'Basophil count normal', 'Basophil percentage decreased', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bilirubin normal', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine normal', 'Blood glucose normal', 'Blood magnesium normal', 'Blood potassium decreased', 'Blood sodium normal', 'Blood thyroid stimulating hormone normal', 'Blood urea nitrogen/creatinine ratio', 'Blood urea normal', 'Carbon dioxide decreased', 'Chest X-ray normal', 'Chest discomfort', 'Cough', 'Dizziness', 'Eosinophil count decreased', 'Eosinophil percentage decreased', 'Glomerular filtration rate', 'Haematocrit normal', 'Haemoglobin normal', 'Hypoaesthesia', 'Immature granulocyte count increased', 'Immature granulocyte percentage increased', 'Injection site hypoaesthesia', 'Injection site pain', 'Lymphocyte count decreased', 'Lymphocyte percentage decreased', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Mean platelet volume normal', 'Monocyte count normal', 'Monocyte percentage decreased', 'Nausea', 'Neutrophil count increased', 'Neutrophil percentage increased', 'Pain in extremity', 'Platelet count normal', 'Protein total normal', 'Red blood cell count normal', 'Red blood cell nucleated morphology', 'Red cell distribution width increased', 'Throat tightness', 'Troponin normal', 'White blood cell count normal']",1,MODERNA,IM 919605,NC,37.0,F,"After~50 minutes from receiving the vaccine, I experienced bilateral numbness of the ears, cheeks, and tongue. This lasted ten to fifteen minutes followed by mild itching of the ears, face, and neck. Upon returning home, contacted my primary physician to report the adverse reactions and self administered Benadryl which eliminated the s/s thus far.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,"Sertraline, Folic Acid, My Kind Organics Prenatal Vitamin, Montelukast, B12 shots, Adult Calcium Gummy, Dapsone, Adapalene.","Flue like symptoms two weeks prior, Flu vaccine on 12/9/20,","Over weight, anxiety,",,"Penicillin, Pseudobrofimide.","['Ear pruritus', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia ear', 'Pruritus']",1,PFIZER\BIONTECH,SYR 919606,AZ,27.0,F,Vaccinated as part of nursing home mass vaccination event on 12/18/2020. Staff of nursing home. Tested positive for COVID-19 on 12/21/2020. Ongoing exposure to COVID+ residents at the home. Minimal symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/21/2020,3.0,SEN,None,None,None,,None,"['COVID-19', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 919607,WA,36.0,F,"Swollen, red, hot, taut skin, onset 1/3/21, rx cephalaxin 7 days",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,01/03/2021,7.0,PVT,Fish oil,None,None,,"Regina, dialudid","['Erythema', 'Skin tightness', 'Skin warm', 'Swelling']",1,MODERNA,IM 919608,MD,53.0,M,Left side of face below eye and goes to the Botox. Of my lips has a numbing feeling.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/30/2020,29.0,WRK,Hydrochlorothiazide Metformin,,,,,['Hypoaesthesia oral'],1,MODERNA,SYR 919609,CA,25.0,F,Swollen lymph nodes on left collar bone,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/28/2020,6.0,WRK,Multivitamins,,None,,None,['Lymphadenopathy'],1,PFIZER\BIONTECH,IM 919610,NE,31.0,F,DEVELOPED SWOLLEN LYMPH NODES AND SORENESS ON NECK AND JAW (LEFT SIDE). WENT TO THE ER AND IS FOLLOWING UP WITH MD ON 1/5/21,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,SEN,,,,,,"['Lymphadenopathy', 'Neck pain', 'Pain in jaw']",1,PFIZER\BIONTECH,IM 919611,MD,42.0,F,"Nausea ,vomiting 48hrs fever 101 maxing out on Tylenol . Body aches Lethargy, Chills. Sore arm. Took anti nausea meds for 4 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,"Topamax 150mg qhs, Prilosec 40mg daily, Xyzal 5mg daily, Unisom 1 tab prn nightly, Citalopram 20mg daily, Bupropion 300mg daily, Albuterol as needed.",no,"Asthma, Migraines, anxiety",,no,"['Chills', 'Lethargy', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,SYR 919612,KS,51.0,F,Patient developed hives that worsened on 12/30/2020. Self treated with topical diphenhydramine cream at home.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,PVT,"Metoprolol, ""Sleep-Aid"", Acetaminophen PRN",None,Fibromyalgia,,None,['Urticaria'],1,PFIZER\BIONTECH,IM 919613,AZ,69.0,F,Vaccinated at mass vaccination event for nursing home staff and residents on 12/18/2020. Staff of nursing home. Developed cough and runny nose and tested positive for COVID-19 on 12/20/2020. Ongoing exposure to sister who lives with her and is also COVID+,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/20/2020,2.0,SEN,None,None,None,,None,"['COVID-19', 'Cough', 'Exposure to SARS-CoV-2', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 919614,MO,50.0,F,"Had heart palpitations within two hours of vaccine, severe headache, body aches, fatigue and shortness of breath. Sore left arm all the way down arm. Rested and took ibuprofen. Today I returned to work still having headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,Took ibuprofen,None,None,,None,"['Dyspnoea', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Palpitations']",1,PFIZER\BIONTECH,SYR 919615,NJ,47.0,F,"Severe fatigue, abdominal cramping, fever 102.7",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/04/2021,2.0,WRK,none,none,none,,none,"['Abdominal pain', 'Fatigue', 'Pyrexia']",1,PFIZER\BIONTECH,IM 919616,CA,46.0,M,"No adverse side effects from vaccine. Just that after 5 days of receiving vaccine, I became infected with Covid-19. Started with symptoms Tuesday Dec. 29 2020 at 6am (Chills, severe body aches) I currently work in a jail setting with active covid-19 cases. Exposure to covid-19 at work high. Covid symptoms as of Jan. 3 2021 have been: mild headache, body aches, muscle stiffness, chills, sinus congestion/runny nose, mild cough, loss of taste/smell.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/29/2020,5.0,OTH,"Atorvastatin, Fenofibrate, Lisinopril, Atenolol, Thiazide",,"High blood pressure , high cholesterol",,"Penicillin , Sulfa","['Ageusia', 'Anosmia', 'COVID-19', 'Chills', 'Cough', 'Headache', 'Musculoskeletal stiffness', 'Occupational exposure to SARS-CoV-2', 'Pain', 'Rhinorrhoea', 'SARS-CoV-2 test positive', 'Sinus congestion']",1,PFIZER\BIONTECH,SYR 919617,FL,27.0,F,"The Sunday after I received the vaccine I had increased hip pain and Sunday night I had a rash anon the L2 and L3 dermatome. I thought it was shingles and made an appt. Overnight the rash spread and it was very painful, On Monday I got Volcite for 7 days and I still have rash (improving) and pain today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/18/2020,1.0,PVT,Chlorhexidine and propranolol,No,No,Just arm soreness,"risperdal, codeine","['Arthralgia', 'Rash']",1,PFIZER\BIONTECH,SYR 919618,WA,22.0,F,dose given too early (day 14),Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,,,,,,['Inappropriate schedule of product administration'],2,PFIZER\BIONTECH,IM 919619,NE,64.0,F,"SHORTLY AFTER VACCINATION, DEVELOPED DIZZINESS, BILATERAL ARMS THAT FEEL ""HEAVY"". RECEIVED 25MG DIPHENHYDRDAMINE BY MOUTH. RESOLVED IN ABOUT 1 HOUR",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,SEN,,,,,,"['Dizziness', 'Limb discomfort']",1,PFIZER\BIONTECH,IM 919620,WA,81.0,M,Decompensation and temp 103.6.,Not Reported,,Yes,Yes,3.0,Not Reported,N,12/01/2020,01/01/2021,31.0,SEN,Mucus Relief Tablet 400 MG (GuaiFENesin) Give 1 tablet by mouth every 8 hours as needed for congestion Prescriber Entered Active01/02/202101/04/2021 Omeprazole Capsule Delayed Release 40 MG Give 1 capsule by mouth in the morning for GERD Ph,,"Dementia, Urinary Incontinence, depression, Edema",,No,"['Body temperature increased', 'Cardiac failure', 'Pyrexia']",1,UNKNOWN MANUFACTURER, 919621,MT,57.0,F,"right after the injection, I got really hot.Then I got very dizzy and shaky. I got a instant headache. I also had a chlorine taste in my mouth. I told the nurse I wasn't feeling well. she sat with me and was asking about how I was feeling. I the started trying to clear my throat. it felt like I had something in my throat. I kept trying to swallow and it just felt like my throat was getting tighter and tighter. that's when they got me on a stretcher and took me to the ER",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,UNK,,none,none,,none,"['Dizziness', 'Feeling hot', 'Headache', 'Immediate post-injection reaction', 'Malaise', 'Sensation of foreign body', 'Taste disorder', 'Throat clearing', 'Throat tightness', 'Tremor']",1,PFIZER\BIONTECH,IM 919622,CO,50.0,M,i was driving and my left eye stopped tracking with my right eye. I had to pull over and let my daughter drive this lasted maybe 3 minutes . I have never had this happen before. I don't get sick or have issues I have never taken a sick day in 20 plus years and I am fairly healthy,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,lisinopril,none,"HTN, moderately high lipid/cholesterol",,none,"['Eye movement disorder', 'Impaired driving ability']",1,MODERNA,IM 919623,AZ,39.0,F,"Vaccinated at mass vaccination event for nursing home staff and residents on 12/18/2020. Developed cough, runny nose, sore throat, loss of taste and smell and tested positive for COVID-19 on 12/24/2020. Had exposure to COVID+ mother whom she takes care of.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/24/2020,6.0,SEN,None,None,None,,None,"['Ageusia', 'Anosmia', 'COVID-19', 'Cough', 'Oropharyngeal pain', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 919624,PA,29.0,F,"Around 10 or 11 pm, arm pain, chills, fatigue, headache, nausea, swollen lymph nodes, lightheadedness, fainted in tub. Next day, fatigue all day, couldn't talk, or eat. Went back to bed again. The following day hot flashes, weakness. went to ER. Felt like blood pressure was dropping, tingling in legs, difficulty lifting her head.",Not Reported,,Not Reported,Yes,,Not Reported,U,12/29/2020,12/29/2020,0.0,WRK,no,no,no,,Penicillin,"['Asthenia', 'Blood pressure decreased', 'Chills', 'Decreased appetite', 'Dizziness', 'Fatigue', 'Headache', 'Hot flush', 'Lymphadenopathy', 'Mobility decreased', 'Nausea', 'Pain in extremity', 'Paraesthesia', 'Speech disorder', 'Syncope']",1,MODERNA,IM 919625,PA,39.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA 12-31-2020 Nausea & Headache, 1-1-2021 Headache 1-2-2021 Headache & shortness of breath, 1-3-2021 Headache, shortness of breath, fatigue,& cold sore on top lip, 1-4-2021 Headache, shortness of breath, cold sore, fatigue, and right shoulder blade and neck hurts.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Valtrex 1mg, topamax 200 mg, Wellbutrin 450mg, lorazepam .5mg, gabapentin 1200mg, trazadone 100mg",None,None,,N/a,"['Arthralgia', 'Dyspnoea', 'Fatigue', 'Headache', 'Nausea', 'Neck pain', 'Oral herpes']",1,PFIZER\BIONTECH,IM 919626,MI,54.0,M,"Patient experienced hypotension (systolic 88mmHg), diaphoresis",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Singulair, Testosterone, Zyrtec, Multivitamin",,,,Diverticulitis,"['Hyperhidrosis', 'Hypotension']",1,PFIZER\BIONTECH,IM 919627,AZ,51.0,F,"Staff member at nursing home vaccinated at mass vaccination event on 12/18/2020 for residents and staff. Developed headache, chills, diarrhea- muscle aches, joint aches on 12/29/2020 and tested positive for COVID-19 on 12/30/2020. Uneventful course isolating at home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/30/2020,12.0,SEN,Metformin Insulin Glargine Cetirizine,None,Diabetes Mellitus Type 2,,Ibuprofen - Rash Bactrim- Nausea,"['Arthralgia', 'COVID-19', 'Chills', 'Diarrhoea', 'Headache', 'Myalgia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 919628,OH,63.0,F,"symptoms started 6 hours after I took the vaccine. Symptoms included temp of 100.6, headache, malaise, joint aches. I had covid late May and gave blood, to the agency on December 18th. Report showed I had antibodies",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,WRK,none,none,hypothyroidism,,only allergy is to sulfa meds,"['Arthralgia', 'Body temperature increased', 'Headache', 'Malaise']",1,MODERNA,IM 919629,OH,51.0,F,20 minutes after receiving the vaccination the resident started to not feel well. She said she felt very far away and just kept repeating I don't feel well. She was diaphoretic and her chest was very red and she kept scratching and rubbing it at it. I asked if she wanted IM Benadryl or epipen and she at first denied. She also said she felt like she needed to focus on her breathing. At this time we decided it was best to administer Epipen x 1 dose. Immediately after she felt better. She was observed for another 30 minutes and then went home. at 7:17pm I called and spoke with her. She said her arm was sore and that her oxygen levels were about 88-89% which is low for her but she said she felt fine and is currently working right now.,Not Reported,,Yes,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,,,,,,"['Erythema', 'Feeling abnormal', 'Hyperhidrosis', 'Malaise', 'Oxygen saturation decreased', 'Pain in extremity', 'Pruritus']",1,PFIZER\BIONTECH,IM 919630,TX,36.0,F,Staff member reported itching to her neck and right axila 25 minutes after vaccine. She was given Benadryl 50mg IM to the left deltoid at 1331 and had resolution of symptoms in minutes.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,None,IBS,IBS,,None,['Pruritus'],1,MODERNA,IM 919631,TN,36.0,M,"Limited range of motion in left shoulder, referred to Orthopedic Surgeon.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/25/2020,2.0,WRK,,,"ADHD, Psoriasis",,,['Joint range of motion decreased'],1,PFIZER\BIONTECH,IM 919632,NC,68.0,F,"Muscle pain feeling Faint , sick stomach. Lower back pain , headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,SEN,Humors,,Ra,,No,"['Abdominal discomfort', 'Back pain', 'Dizziness', 'Headache', 'Myalgia']",UNK,MODERNA, 919633,MS,49.0,F,"Presented to the ED with cc of left sided facial and LUE numbness and weakness x 1 days. Patient received her COVID-19 vaccination on 12/30/2020 around 1PM. Immediately after the injection in her left shoulder, she began to feel warmth and numbness in her left shoulder, arm, neck, face, and chest. She reports later experiencing nausea, palpitations, and left arm weakness. Her symptoms persisted, and her family noted a left sided facial droop which prompted her ED visit. � In the ED, patient was noted to have some left sided facial droop and left arm and leg weakness. CT head and CTA showed no acute abnormalities. Tele-neurology was consulted who recommended admission to rule out acute stroke. Ultimately, work up was negative and symptoms resolved. Symptoms appear to be related to the vaccine.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/04/2020,12/30/2020,361.0,PVT,Albuterol 90 mcg/actuation 2 puffs inhaled q4h prn sob/wheezing Aspirin EC 81 mg PO Daily Bupropion SR 150 PO Daily Calcium carbonate + Vitamin D 600mg PO Daily Cinnamon Bark 2 capsules PO Daily prn Clonazepam 0.5 mg PO Daily prn anxiety Cl,,Asthma Fibrocystic breast disease Hyperlipidemia Irritable bowel syndrome Insomnia Migraines Polycystic ovarian syndrome,,"Latex gloves - Anaphylaxis Iodine - Swelling Shellfish - Unknown Oseltamivir - Unknown Tramadol - Itching, N/V","['Alanine aminotransferase normal', 'Angiogram cerebral normal', 'Anion gap decreased', 'Arteriogram carotid normal', 'Aspartate aminotransferase normal', 'Basophil count normal', 'Basophil percentage', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bilirubin normal', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine normal', 'Blood glucose normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea nitrogen/creatinine ratio', 'Blood urea normal', 'Carbon dioxide normal', 'Chest X-ray normal', 'Computerised tomogram head normal', 'Electrocardiogram', 'Eosinophil count normal', 'Eosinophil percentage', 'Facial paralysis', 'Facial paresis', 'Feeling hot', 'Glomerular filtration rate', 'Haematocrit normal', 'Haemoglobin normal', 'Hypoaesthesia', 'Immature granulocyte count increased', 'Immature granulocyte percentage increased', 'Immediate post-injection reaction', 'Injection site hypoaesthesia', 'Injection site warmth', 'Lymphocyte count normal', 'Lymphocyte percentage decreased', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin decreased', 'Mean cell volume normal', 'Mean platelet volume increased', 'Monocyte count normal', 'Monocyte percentage', 'Muscular weakness', 'Nausea', 'Neutrophil count normal', 'Neutrophil percentage increased', 'Palpitations', 'Platelet count normal', 'Protein total normal', 'Red blood cell count normal', 'Red blood cell nucleated morphology', 'Red cell distribution width', 'White blood cell count normal']",1,MODERNA,IM 919634,LA,29.0,F,"12/21 - Fever (101.5), lethargy, headaches 12/22 - lethargy and headaches 12/23 - lethargy and headaches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/21/2020,2.0,PVT,"BuSpar, Lexapro, Xyzal, Trazadone, Synthroid",TMJ,"Hypothyroidism, Generalized Anxiety Disorder",,"Tomatoes, Citrus","['Headache', 'Lethargy', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,SYR 919635,AZ,50.0,F,"Nursing home staff member vaccinated at mass vaccination event for nursing home residents and staff on 12/18/2020. Developed headache, cough, runny nose on 12/26/2020. Tested + for COVID-19 on 12/28/2020. Recovering well at home. No hospitalization or ED visits.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/28/2020,10.0,SEN,None,None,None,,None,"['COVID-19', 'Cough', 'Headache', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 919636,TX,45.0,M,Sweating Deep cough Eyes burning Body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,MIL,,,,,,"['Cough', 'Eye irritation', 'Hyperhidrosis', 'Pain']",1,MODERNA,SYR 919637,WI,16.0,F,No adverse reaction - vaccine was administered to a employee that was 17 years of age,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2020,01/04/2020,0.0,PHM,,,,,,"['Inappropriate schedule of product administration', 'No adverse event']",1,MODERNA,IM 919638,LA,49.0,M,"On December 23, 2020 she had the Pfizer COVID-19 vaccination at 7:30 p.m. She then worked her shift as a dialysis nurse and went home the following morning. She did not have any symptoms until 5:00 p.m. the following afternoon when she woke up. She developed itching of her back and a mild erythematous rash across her chest. That evening around 7:00 p.m. she noticed a rash on her arms that was itching. At 7:30 p.m. she had tightness in her chest and a nonproductive cough. She attributed the symptoms to her asthma. Her symptoms improved throughout the night. She went home on Christmas morning and went to bed. She woke up at around 5:00 p.m. She had swelling of her eyelids and an urticarial rash across her face and chest. She did have some mild throat itching. She reported to work at 7:00 p.m. but continued to have symptoms with increasing shortness of breath. She reported to the emergency department and was evaluated. She was given famotidine, Methylprednisolone, and hydroxyzine. She was also given ipratropium/albuterol nebulized. Her respiratory symptoms did improve, and she was discharged around midnight. She continued to have a slight erythematous rash that was present until she went to bed the following morning. When she woke up it had resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,Zyrtec Pantoprazole Cryselle Omnicef,"URI diagnosed as ""sinus infection"". Chronic rhinitis, conjuctivits, and asthma, consider allergic. GERD.",Nephrolithiasis. Above.,Patient reported URI lasting 6 weeks after flu vaccination in 2008 and 2019,Niacin rash,"['Chest discomfort', 'Cough', 'Dyspnoea', 'Pruritus', 'Rash', 'Rash erythematous', 'Rash pruritic', 'Swelling of eyelid', 'Throat irritation', 'Urticaria']",1,PFIZER\BIONTECH,IM 919639,MT,45.0,F,"Tingling of face for a couple hours, starting 2 hours after vaccine, gone by the next day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,,,,,None,['Paraesthesia'],UNK,PFIZER\BIONTECH, 919640,TN,26.0,F,got the shot around 11 am on 12/26 and my mouth became immediately parched. My arm was super sore as the day went on and around 4:30 am I woke up shivering with chills and aches and a mild temp of 99. Passed out and BP was extremely low. Parents called an ambulance and I went to Emergency room.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/27/2020,1.0,PUB,jolessa (birth control),none,none,,Zithromax medro dose pack,"['Blood test', 'Chills', 'Dehydration', 'Dry mouth', 'Hypotension', 'Loss of consciousness', 'Pain', 'Pain in extremity', 'Urine analysis']",1,MODERNA,SYR 919642,ME,45.0,F,"8 days after first vaccination site immediately below injection area in right arm became itchy, swollen, red and tender. Redness has been spreading.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/03/2021,8.0,PVT,Armour Thyroid,None,Autoimmune Thyroid Disease - Hashimotos,,Codeine and Vicodin,"['Immediate post-injection reaction', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 919643,NY,58.0,F,"Tingling, numbness lips and tongue, tightness in throat. Benadryl taken",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Omeprazole, famotidine, turmeric, vitamin d, vitamin c,",,"Gerd, ezcema",,"Codeine, ceclor, amoxicillin, nexium, pseudophed","['Hypoaesthesia oral', 'Paraesthesia oral', 'Throat tightness']",UNK,PFIZER\BIONTECH,IM 919644,,55.0,F,Dec. 29: she developed arm soreness and joint pain. Dec. 30: she developed pain in chest area radiating towards the back Jan. 01: she noticed a rash in the mid abdomen radiating towards the back. She has been experiencing pain in the affected area.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/29/2020,1.0,UNK,,,,,,"['Arthralgia', 'Back pain', 'Chest pain', 'Pain', 'Pain in extremity', 'Rash']",1,PFIZER\BIONTECH,IM 919645,NY,50.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine received at 11:40 AM. At approximately 9pm I began to experience whole body chills, teeth chattering, and extreme fatigue. I took Ibuprofen and went to sleep. I experienced chills until approx 3 AM. My watch alerted my heart rate rose above 120 bpm three separate times during the night in the 1, 2 and 3:00 hours. Upon review of the summary it appears to have been sustained at just over 120 for that entire time. I awoke at noon, with a temp of approx 99.5 F, I felt extreme fatigue and a sense of cold but body was warm to touch and I was very sweaty this entire time. I slept most of the day and at 5 pm awoke with a temp of 102.4F. I contacted my physician who directed me to use tylenol and Benadryl. I took a dose at 5 pm, anther at 9 PM. Upon waking the next morning I was afebrile. At that time I felt slightly dizzy and lightheaded but also dehydrated. Forcing fluids relieved symptoms. I experienced a very mild headache and very mild queasiness as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,"Allegra, Singulair, Procardia XL, Lipitor, multivitamin","asthmatic bronchitis started 12/9. 12/9 Started zpac, prednisone taper (starting with 40mg) and albuterol nebulizer Q4hrs. Extended 10 day prenisone taper with 10 mg daily for 7 days per MD completed 12/25.","Asthma, environmental allergies, HTN, Hypercholesterol",vitiligo reaction where bandaid adhesive touched skin after flu Vaccine approx 10 years ago,grade 1 allergy to casein,"['Body temperature increased', 'Chills', 'Dehydration', 'Dizziness', 'Fatigue', 'Feeling cold', 'Headache', 'Heart rate increased', 'Hyperhidrosis', 'Nausea', 'Skin warm', 'Somnolence']",1,PFIZER\BIONTECH,IM 919646,OH,64.0,M,"Patient began having headache and fatigue 12/29. Early morning of 12/30 patient reported severe chills. Felt better during the day of 12/30 with only a headache. Night of 12/30 patient reported severe chills again and wanted to call the doctor in the morning, but the felt better on 12/31. The night of 12/31 patient again had chills, but less severe (rated 3/10 on scale). Night of 1/1 patient reported slight hive like rash that went away with warm Epsom salt bath. 1/3 0100 patient woke up with severe hives down back of legs and lower back. Got into a hot tub to soak and once the patient got out he was standing at the sink and passed out. His wife got him back to bed. Around 0700 on 1/3 patient woke up to urinate and he passed out again. He states both times he passed out felt the same stating ""I felt like I was going to vomit and then all of a sudden I couldn?t breath, almost like I was choked out.""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PUB,,,Splenectomy. Cancer survivor.,,,"['Blood thyroid stimulating hormone', 'Chest X-ray', 'Chills', 'Choking sensation', 'Dyspnoea', 'Electrocardiogram', 'Fatigue', 'Full blood count', 'Headache', 'Loss of consciousness', 'Metabolic function test', 'Nausea', 'Troponin I', 'Urticaria']",1,MODERNA,IM 919647,NY,57.0,F,Lips started tingling,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,,,,,"Thimerosol, artificial sweeteners, msg, mushrooms, cats, rabbits, seasonal allergies",['Paraesthesia oral'],1,MODERNA,IM 919648,CA,38.0,F,"Pain, sore, and swelling of the left axilla (underarm).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/01/2021,4.0,PVT,Prenatal vitamins,,,,Avocado Sulfa-medication,"['Axillary pain', 'Swelling']",1,MODERNA,IM 919649,CA,53.0,F,"PATIENT RECIVED THE FIRST MODERNA VACCINE , WAS OBSERVED FOR 15 MINUTES. AT 25 MINUTES PATIENT REPORTS FEELING HOT , FLUSHED , TONGUE AND LIPS FELT SLIGHTLY SWOLLEN AND TINGLING , PROGRESSING TO SWELLING AND TINGLING OF FACE . SHE WAS EVALUATED BY RN AND MD . SHE RECVIED 50MG OF DIPHENHYDRAMINE BY INJECTION . SYMPTOMS IMPROVED OVER THE NEXT 30 MINUTES.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"LOSARTAN , LEVOTHYHROXINE,ASPRIN , METFORMIN , VITAMIN -D",NONE,"HYPERTENSION , DIABETESE TYP 2 ,THYRIOD (HASHIMOTOS),LUPUS",,"SULFA , BACTRIN, PENICILLIN , AVOCADO","['Feeling hot', 'Flushing', 'Lip swelling', 'Paraesthesia', 'Paraesthesia oral', 'Swelling face', 'Swollen tongue']",2,MODERNA,IM 919650,TX,45.0,F,"Redness, swelling, hot to touch, itchy but not until 10 days later.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/02/2021,9.0,WRK,"Yaz/BC, Nexium, Allegra D",,,,Penicillin,"['Erythema', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,IM 919651,TX,42.0,M,Staff member reported left arm felt heavy and was very nervous with sweaty palms 13 minutes after vaccination. He received Benadryl 25mg IM to his right deltoid and he reported symptoms subsided 1 hour after Benadryl and was symptom free for 6 hours. He reported body aches and HA the next day through 12/27/20 and then complete resolution of symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,"Atarax PRN, Gabapentin PRN, Ibuprofen PRN","sleep apnea, insomnia, herniated disc L4/L5, tinnitus","sleep apnea, insomnia, herniated disc L4/L5, tinnitus",,None,"['Headache', 'Hyperhidrosis', 'Limb discomfort', 'Nervousness', 'Pain']",1,MODERNA,IM 919652,CA,48.0,F,"After the injection, my arm was sore, heavy chest down the left arm with tingling, titanium left breast marker was throbbing, cough with excess mucus. No fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,UNK,I take vitamins & minerals,No,No,,I am allergic to cantalope and seasonal allergies.,"['Chest discomfort', 'Pain in extremity', 'Paraesthesia', 'Productive cough']",1,MODERNA,IM 919653,CA,46.0,F,"Patient states she was advised by nurse that because it was intermuscular (triceps), it may be because she is experiencing a headache that lasted 36 hours, also fatigue for 5 days, also joint stiffness for 7 days and she states she felt very sore and stiff and had a hard time walking up and down stairs without feeling shortness of breath. Said she felt ""run down"". On day 8 (12/31) she felt a lump like a mosquito bite. Day 9 the injection site became red and became very hot to touch. No fever reported. She was advised to see a nurse and was advised it could be hypersensitivity and to report this. This happened on 01/02/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,WRK,Blood pressure medications,,,,,"['Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Gait disturbance', 'Headache', 'Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site warmth', 'Joint stiffness']",UNK,PFIZER\BIONTECH, 919654,NM,38.0,F,patient developed a rash on face and neck,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PHM,Lisinopril 40mg Hydrochlorthiazide 25mg,none,high blood pressure,,none known,['Rash'],1,MODERNA,IM 919655,VA,30.0,M,"Fevers, chills, headache, and fatigue occurred 12 hours after receiving first dose. Symptoms lasted for 48 hours and were managed with Nyquil, fluids, and rest.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,None,No e,None,,None,"['Chills', 'Fatigue', 'Headache', 'Pyrexia']",UNK,MODERNA,IM 919657,HI,54.0,M,"Patient vaccinated with COVID vaccine on 12/18/2020. On 12/20/2020 he began having swelling of the left ankle. Patient previously had surgery to this ankle where plates and screws were placed. Patient was seen at Urgent Care on 12/21/2020, who prescribed Antibiotic and followed up with his podiatrist a week later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/20/2020,2.0,MIL,"amlodipine, Synthroid, multi-vitamin",none,"hypothoidism, hypertension",,amoxicillin,['Joint swelling'],1,PFIZER\BIONTECH,IM 919658,,49.0,F,"First sharp headache after an hour, then metallic taste. 36 hours after muscle aches, chills, flu like symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,UNK,,,,,,"['Chills', 'Dysgeusia', 'Headache', 'Influenza like illness', 'Myalgia']",1,MODERNA,SYR 919659,CA,27.0,F,Headache Body sore Chills Cold Sweats Sore throat,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,UNK,,Close contact with person positive with Covid on 1/2/2020 but has not been tested since being positive for covid herself in October,,,,"['Chills', 'Cold sweat', 'Headache', 'Oropharyngeal pain', 'Pain']",1,MODERNA,SYR 919660,ME,42.0,F,"Inflamed reddened area, size of baseball, under injection site. This was slightly swollen and itchy. 8 days after receiving injection. Have treated with Benadryl Cream and oral Claritin. No further complicating factors at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,01/03/2021,8.0,WRK,Multivitamin and Vitamin D.,None.,None.,,Sulfa and Tetracycline,"['Injection site erythema', 'Injection site inflammation', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 919661,OR,46.0,F,"Throat swelling, urticaria",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,"Imitrex, Triple antibiotic, Tylenol","['Pharyngeal swelling', 'Urticaria']",UNK,PFIZER\BIONTECH, 919662,MI,42.0,F,"On day 9 or 10, I developed a reddened area at injection site about the size of a quarter. It has since grown to about the size of a baseball. It is raised, red and warm to touch. And it itches like crazy!",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,01/02/2021,10.0,PUB,Zoloft 100 mg daily,None,None,,NKA,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 919663,VA,26.0,F,"Itchy throat (internal), weakness/dizziness 10 minutes following vaccine. I was given 50 mg of Benadryl which stopped these side effects. Four hours later (around 3 PM) I experienced numbness in my left arm and hand. I am still experiencing this side effect.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2020,01/04/2021,366.0,WRK,Zyrtec allergy medicine,None,None,,allergic to pollen (hay fever),"['Asthenia', 'Dizziness', 'Hypoaesthesia', 'Throat irritation']",1,MODERNA,SYR 919664,NY,49.0,F,"Intense pelvic/thigh ache started day 2. I still have the ache, but it?s tolerable. I am very fatigued. Nausea the first two days, with diarrhea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/01/2020,,SEN,"CBD, Tylenol, Atorvastatin, paxil",Sinus infection,CAD Irritable bowel syndrome Depression/anxiety,,"PCN, cats","['Diarrhoea', 'Fatigue', 'Nausea', 'Pain in extremity', 'Pelvic pain']",1,PFIZER\BIONTECH,SYR 919665,NJ,28.0,F,"Severe joint aches, fever-type symptoms, nausea",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Synthroid Claritin Dexilent Terbinafine Vitamin D & B12,,Hypothyroid GERD,,Bactrim,"['Arthralgia', 'Blood test', 'Chest X-ray', 'Nausea', 'Pyrexia']",1,MODERNA,IM 919666,FL,64.0,F,"Nausea starting at 1330 12/25/2020, severe nausea with forceful projectile vomiting every half hour beginning at 2330 through 0800. Nausea for next 5 days. Low grade temp 12/26. Severe diarrhea beginning 12/26 afternoon through 12/17 am. Muscle aches through New Year's Eve. Mod to severe dehydration. Lost 10 pounds I had chemo 9 years ago and I don't recall ever being that sick",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/25/2020,2.0,PVT,vibryd gabapentin Roberinole Trazadone B12 Calcium/Vit D3,none,Depression Asthma (no problems for past 9 years) Sleep apnea Restless Leg,,PCN Cephalosporins Latex molds,"['Dehydration', 'Diarrhoea', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting projectile', 'Weight decreased']",1,MODERNA,IM 919667,OH,53.0,F,"Adenopathy: painless ipsilateral to vaccination site (left) supraclavicular/neck adenopathy noted 5 days after vaccine, then tender ipsilateral (left) axillary adenopathy noted 6 days after vaccine, along with smaller prominent right (contralateral) lymph node.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,PVT,None,None,N/a,,Penicillin,"['Lymphadenopathy', 'Tenderness']",1,MODERNA,IM 919668,IL,61.0,F,Lethargy and headaches for 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,,,,,,"['Headache', 'Lethargy']",1,PFIZER\BIONTECH,IM 919669,TX,20.0,F,"Received shot around 4pm. First 10 minutes, then arm started throbbing. started getting dizzy and fatigue. Had weakness and abdominal pain, sweating profusely. Couldn't cool down. Felt winded, severe abdominal pain 10-15 minutes. Still having pain at the injection site. started having chills and then started to fell better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,no,no,no,,"Codeine, Bay leaves","['Abdominal pain', 'Asthenia', 'Chills', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Feeling hot', 'Hyperhidrosis', 'Injection site pain', 'Pain']",1,MODERNA,IM 919670,TN,42.0,F,"Approximately 1week after injection I developed a large red area at injection site. The red area is 2 in long and 5 in wide on multiple right arm, at and below injection site. The area is raised slightly, itching, sore and has small welps. Present for 3 days, ice, Benadryl helped to decrease, then return after 2 more days. Large area is still present. I have not seen physician for reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PUB,"Lisinopril, Lo loestrin, Claritin, multi vitamin",None,"High blood pressure, seasonal allergies",,"Latex, adhesives, codeine, metronidazole, sulfa, tinidazole","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Urticaria']",1,MODERNA,IM 919671,TX,34.0,F,Pt. began having SOB shortly after vaccination. The pt. reported having difficulty breathing and 0.3mg epi SQ was administered by on site medic team. The patient had 95-100% 02 sat and left in stable condition with a reported 135/80 BP with 110 HR.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PUB,,,"anxiety, back problems",,"Shellfish, Iodine",['Dyspnoea'],1,MODERNA,IM 919672,PA,36.0,F,"Moderna vaccine viability per vial is 6 hours once the cap is popped off and the rubber seal is punctured. This was misunderstood by the staff providing the vaccine; this patient was provided the vaccine injection from this same vial the next day, well over the 6 hour limit. No significant adverse signs or symptoms noted from the patient following vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,WRK,Unknown,Unknown,Unknown,,Unknown,"['No adverse event', 'Poor quality product administered']",1,MODERNA,IM 919673,CA,53.0,F,"At pre-vaccine screening patient reported no contra-indications so had the vaccine. Roughly 45 minutes later patient reported shortness of breath, not feeling good and not being able to hear properly. Blood pressure was taken immediately at 1.38pm - 189/96mmHg and pulse -88bpm, and again at 1.43pm -180/90mmHg. Emergency services were contacted and came immediately within 3-5mins. After assessing patient they took her to hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,SEN,,no fever or sickness reported at time of vaccination,,,Morphine and keflex,"['Dyspnoea', 'Feeling abnormal', 'Hypoacusis']",1,PFIZER\BIONTECH,IM 919674,WA,50.0,F,I received the shot and about one minute later I felt a little dizzy and light head. They sat me down and about couple minutes later I felt my heart rate racing and felt flushed. I reported how I felt the the staff and they put me in a recliner. The rapid heart rate went away about a minute later. I stayed at the vaccine clinic for total of 35 minutes after the shot. They made sure I felt o.k. before I left. I didn't have that feeling again. I felt fine the rest of the day and today. I have had that same feeling before not from vaccine. I have never had reaction to vaccine or medications. 2 years ago I thought I was allergic to avocado or avocado oil because I had a couple of incidence of having that same dizzy fast heart rate feeling after avocado oil. I went to an allergist and got tested and was negative for avocado and he also tested me for shell fish because I have had history of being itchy after eating shellfish. I was negative for both. I haven't had that same reaction for several years since that incident. I have been able to eat avocado and shellfish without problem. I don't really know if this is an allergic reaction or an immune response to the vaccine. I am going to see my allergist on 1/6/21 see what he thinks. I am wondering if I should get the second dose.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,omega 3 and vitamine D,none,none,,"dust, pollen and pet dander","['Dizziness', 'Hot flush', 'Immediate post-injection reaction', 'Palpitations']",1,MODERNA,IM 919675,TX,26.0,F,Bell?s Palsy. Right-sided facial drooping. Numbness to right face. Excessive tearing of right eye associated with inability to blink right eye.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PVT,None,None,None,,"Avocado, bananas, latex","['Eyelid function disorder', 'Facial paralysis', 'Hypoaesthesia', 'Lacrimation increased']",1,MODERNA,IM 919676,CA,58.0,F,Fever up to 101.3 for 55 hours Chills for 55 hours Body Aches for 55 hours Headache for 72 hours Fatigue for 72 hours Nausea for one hour Sore arm for 72 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Levothyroxine, Atorvastatin, Estradiol","COVID-19 starting Dec 13, 2020. Quarantine complete Dec 24, 2020.","Migraines, high cholesterol, hypothyroidism",,Biaxin (sensitivity rather than allergy),"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 919677,TN,55.0,F,"Severe chills, fever, headache, diarrhea Starting approx. 8:30 PM on 12/30/2020 until approx. 12:30 am 01/01/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,Gabapentin 600mg once at night,None,None,,None,"['Chills', 'Diarrhoea', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH,IM 919678,CA,48.0,F,"Patient reports soreness in the arm, headache onset, sneezing, runny nose and itchy in throat, itchiness in eyes and on ears. Patient states she has allergies and also asthma, all itchiness is related to her allergies.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,Take generic for Claritin and uses an inhaler as needed,,,,,"['Ear pruritus', 'Eye pruritus', 'Headache', 'Pain in extremity', 'Rhinorrhoea', 'Sneezing', 'Throat irritation']",UNK,MODERNA, 919679,OH,56.0,F,Red welt about 4 inches wide and 3 inches long around injection site 3 days after injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,WRK,"Cymbalta, levothyroxine, Simastatin, omeprazole, hydroxychloroquine, MELATONIN, hydroCHLOROthiazide, MAGNESIUM, ergocalciferol, Calcium Carbonate, iron, fluticasone,",None,"Lupus, HTN, Hyperthyroidism, CKD, Fibromyalgia, Aortic valve stenosis",,"Penicillins, Meperidine, Quinolones, Levofloxacin","['Injection site erythema', 'Urticaria']",1,MODERNA,IM 919680,WA,37.0,F,Anaphylaxis reaction,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,UNKNOWN,NO,NO,,NICKEL,['Anaphylactic reaction'],2,PFIZER\BIONTECH,IM 919681,MI,38.0,F,Red itchy water painful eye,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,"Tylenol, Lexapro","Right eye, red, itchy, watery, painful at times",,,Nka,"['Eye pain', 'Eye pruritus', 'Lacrimation increased']",1,PFIZER\BIONTECH,IM 919682,NY,33.0,M,Low degree fever (99.8 F) in the night of 01/02 until the afternoon of 01/03. Sore left arm and feeling unwell throughout the day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,WRK,,,,,,"['Malaise', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 919684,MO,46.0,F,"Patient was feeling faint and placed on a cot with feet elevated above heart, vital signs were taken. Vital signs were as follows: BP was 109/74, Pulse 61. Provided cool wet cloth and water. Vitals were taken again: BP 120/84 and Pulse 73. Patient was placed in sitting position for 5 minutes, patient fully recovered and released.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,,,,,NKDA,['Dizziness'],1,PFIZER\BIONTECH,IM 919685,OK,42.0,F,"Patient complained of shortness of breath, chest tightness, and throat closure",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,Unknown,None stated,None stated,,Not specified,"['Chest discomfort', 'Dyspnoea', 'Oropharyngeal discomfort']",1,PFIZER\BIONTECH,IM 919686,MI,56.0,F,My tongue felt swelled and I had a metallic Taste in my moth,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/30/2020,29.0,PVT,Lisinopril Multi vitamin Vitamin D3 Baby aspirin,No,Sinuses issues HBP,,,"['Dysgeusia', 'Paraesthesia oral']",UNK,PFIZER\BIONTECH, 919687,CA,38.0,F,"7 days after the injection, on 12/31 morning, hives appeared 10cm below the injection site to left arm. Progressively, left arm became red, warm to touch, hard, swollen, itchy and painful through the course of the day. It spread rapidly and pain was radiating under left breast, where the lymph nodes are located, behind back/shoulder. The following day it has spread even further, down to elbow; numbing/tingling sensation radiating to left pinkie and left ring fingers. Vital signs: higher than normal systolic BP 130-150s (normal for me:100-110s); tachycardic with HR in 130-140s on the first day of the adverse event, O2 sats normal high 90s to 100% on RA. No fever, highest temp 99.2F.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,12/31/2020,7.0,UNK,,,Eczema,,,"['Chest pain', 'Erythema', 'Hypoaesthesia', 'Injection site urticaria', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Peripheral swelling', 'Pruritus', 'Skin induration', 'Skin warm', 'Tachycardia']",UNK,MODERNA, 919688,WA,30.0,F,"For 2 days after the vaccinations, my left deltoid/ upper arm was sore. Approximately 7-8 days after my vaccination, my left armpit started feeling sore. This has continued to today where I have left armpit swelling and what feels to be a swollen, hardened lymph node in my armpit. It feels like a hardened lump that is not fixed and is tender when I palpate it. On visual inspection, I can tell that my left armpit is more swollen than my right armpit (which is normal). It hurts to have my arm at my side and it hurts to lay on my left side at night when I am sleeping.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/29/2020,7.0,PVT,None,None,None,,Sulfa medications,"['Axillary pain', 'Induration', 'Injection site pain', 'Lymphadenopathy', 'Oedema peripheral', 'Sleep disorder', 'Tenderness']",1,PFIZER\BIONTECH,IM 919689,CA,57.0,F,"Pt reported feeling dizziness, lightheaded, near syncope, numbness/tingling up neck into chest area, numbness and tingling in extremities. Feeling of impending doom, chest pressure with SOB. Pt was given Epi-Pen 0.3mg in clinic, transported via EMS to local ER at which time 50IV Benadryl given while in Ambulance, and 4mg decadron in ER. Pt was discharged from ER at 3:00pm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Trulicity, Lantus, Novolog, Glucophage, Lotrel, Indamipide, Low dose Aspirin, Multi-Vitamin",Bronchitis -November 2020,"Diabetes type 2, HTN, Asthma",,"Levoquin, Norco, cymbalta","['Anxiety', 'Chest discomfort', 'Dizziness', 'Dyspnoea', 'Epinephrine', 'Hypoaesthesia', 'Paraesthesia', 'Presyncope']",1,MODERNA,IM 919690,TX,50.0,F,"dizziness, palpitations and lightheadedness right after vaccination and lasted up to 2 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,zyrtec and biotin,none,none,,none,"['Dizziness', 'Immediate post-injection reaction', 'Palpitations']",UNK,PFIZER\BIONTECH,IM 919691,RI,40.0,M,"Pt entered observation around 1950. Around 2010, stated that ""his body felt warm and tingling, throat was sore, and he had a flush feeling"". Denies SOB or chest pain when asked. Continued to remain in observation. Stated that he felt somewhat better around 2015. Still had the same symptoms but they were letting up some. Around 2025, he stated that he felt better and the symptoms had stopped. Pt left observation @ 2027",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,Zrtyec,,,,,"['Feeling hot', 'Hot flush', 'Oropharyngeal pain', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 919692,AZ,57.0,F,"Itchiness in scalp, face and both arms that feels like bugs crawling on my skin, since 1/3. Nausea and diarrhea on 1/4 in the morning, and still have the itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,OTH,"Buproprion, Lexapro, Spironolactone, Acetaminophen",None,"COPD, Morbid Obesity.",,"Augmentin, Shrimp","['Diarrhoea', 'Formication', 'Nausea', 'Pruritus']",1,PFIZER\BIONTECH,IM 919695,TX,60.0,F,Day 8 injection sight is read swollen and really itchy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/04/2021,9.0,PVT,"Atenolol, hydrochlorothiazide, fluoxetine, Atorvastatin",None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 919696,WA,91.0,F,Arm rash and increased fatigue.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/03/2021,5.0,SEN,"Acetaminophen try 25 calves, aspirin 81 mg delayed release, amlodipine 5 mg tab, Atorvastatin 10 mg tab ,Celexa 10 mg 1/2 tab, vitamin D3 2000 units, Cosopt eye drops twice nailing, culture Rella capsule once daily, Eliquis 2.5 mg tablet t",1.Paroxysmal atrial fibrilla tion. 2. Fatigue chronic. 3. Essential hypertension. 4.Chronic hyponatremia. 5 .General anxiety disorder. 6.Orthostatic hypotension 7 .Major depressive disorder 8. COVID-19 symptoms and the infection,"1.Paroxysmal atrial fibrillation , syncope and collapse, dizziness and giddiness, dyspnea, glaucoma, heart failure, hyperlipidemia, hypokalemia, anginal symptoms.",,"Codeine, hydrocodone, morphine, tramadol, nepafenac ophthalmic suspension","['Fatigue', 'Full blood count', 'Metabolic function test', 'Rash']",1,PFIZER\BIONTECH,IM 919697,OK,53.0,F,"Rash on left arm, stomach, upper left thigh. The rash on stomach has spread to under left arm, and on back now. The rash is not sold.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,"Metoporolol Tartrate 50 mg, Thyroid {armour} 30 mg, Naproxen 500 mg EC, Cetirizine HCL 10 mg, Omeprazol 40 mg, Vitamin B complex, Benadryl, Tylenol, NuSkin Nano Vitamin Pack.",Sinus infection,Thyroid,,"E-mycin, Tordol, Motrin,",['Rash'],1,MODERNA,IM 919698,MO,50.0,F,Constant and severe Pain from injection site traveling all the way up my arm and into my neck.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/22/2020,1.0,PUB,Excedrin,None,Psoriatic Arthritis,,Ibuprofen,"['Injection site pain', 'Neck pain', 'Pain']",1,PFIZER\BIONTECH,SYR 919700,OK,36.0,F,"Sudden rash and slight swelling when I woke up the morning of January 3rd, I applied benedryl cream once in the afternoon and right before bed. When I woke up the next morning, January 4th, the injection site was swollen to the size of a softball, hot to the touch, red and very hard and painful. No treatment successful as of yet. I have not seen a Healthcare professional because I haven't found one that knows what to do for it yet. Just spoken to nurses over the phone.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/03/2021,7.0,PVT,"Wellbutrin, lovora",Sinus congestion 3 weeks before vaccination,None,,None,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Rash', 'Swelling']",1,MODERNA,IM 919702,NH,36.0,F,"Initial reaction included sore arm developing into hard and swollen bump at the injection site. Progressively improved and then on day 8, started noticing large red rash area surrounding the injection site. Warm to touch, not itchy, but significantly larger than the original site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/31/2020,8.0,PVT,"Birth control, daily vitamins, vitamin D, vitamin C, elderberry, Methimizole",None,,,None,"['Injection site induration', 'Injection site mass', 'Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity', 'Rash erythematous']",1,MODERNA,SYR 919703,,29.0,F,slight tingling on nose and mouth,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Albuterol, Ativan, Alvesco, Fluoxetine,. Mometasone",,,,Erythromycin base,['Paraesthesia oral'],1,MODERNA,IM 919704,IN,29.0,M,"AT 4:15am 1/4/2021 I was either dreaming or actually massaging my left trapezius muscle which I was doing because it hurt and the pain was severe 9/10. Thinking it was because I was lying on my side, I sought to move onto my back. My wife was awake during the whole event. Upon moving over to my back I very quickly felt my legs jerking uncontrollably and could not open my mouth. This sensation last for about 10 seconds at which point my legs stopped jerking , and I was able to open my mouth. I felt a sudden rush of warmth, proceeded to throw off the covers, and was then followed not too soon after by intense chills and feeling cold. Immediately after coming to, I noticed I felt nauseated which after a few minutes began to subside. My wife mentioned she tried to gently rouse me but I was unresponsive by touching and calling my name. After 5 seconds of jerking of the legs, she mentioned it sounded like I was trying to gasp for air but could not seem to get air in. This continued for another 5 seconds with the leg jerking. The episode ended as mentioned above.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/04/2021,1.0,OTH,none,COVID and Strep throat,pre-hypertension,,none,"['Chills', 'Dyskinesia', 'Dyspnoea', 'Feeling cold', 'Feeling hot', 'Myalgia', 'Nausea', 'Sleep disorder', 'Trismus', 'Unresponsive to stimuli']",1,MODERNA,SYR 919705,WI,31.0,F,"Moderna: Initially had a burning sensation at injection site for a few hours. That turned into a sore arm with some localized swelling for two days. On 1/1/2021, I woke up with a very swollen lymph node on the left side of my neck. I was very tired and had no energy for three days. The lymph node is still swollen and I am 9 days out from the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,01/01/2021,6.0,UNK,"Allegra, Benadryl, Junel birth control, Breo ellipta inhaler, zafirlukast, also doing allergy immunotherapy x3 months and started Dupixent on 12/22/2020 for first injection",No acute illnesses,"Aspirin exacerbated respiratory disease (AERD) which consists of: Asthma, Allergies, Nasal polyps",,"NSAIDS, environmental, very sensitive to narcotic pain medication","['Asthenia', 'Fatigue', 'Injection site pain', 'Lymphadenopathy', 'Pain in extremity', 'Swelling']",1,MODERNA,IM 919706,NH,35.0,F,"Intense headache for 72 hours immediately after vaccine, hot/sweaty immediately after vaccine then again when NSAIDs wore off that night and into next day, extremely painful arm for 72 hours, muscle very hard at injection site for 72 hours, bruise still present at injection site 6 days post (never bruised for vaccine before)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,"Multivitamin, nasocort, fexofenadine",,"Allergies, PVCs, asthma","MMR vaccine, infancy, severe rash",,"['Feeling hot', 'Headache', 'Hyperhidrosis', 'Immediate post-injection reaction', 'Injection site bruising', 'Muscle rigidity', 'Pain in extremity']",1,MODERNA,IM 919707,CA,29.0,F,"Nausea and dizziness 5 minutes after injection. Vomiting 20 minutes after injection. Throat felt scratchy and c/o chest felt ""heavy"" 25 minutes after injection. Gave Epinephrine 0.3mg IM x1 and placed on oxygen 2L/min via mask. EMS contacted. She declined EMS transport to hospital. EMS gave Zofran ODT (dose unknown). Nausea improved. Breathing improved, but still c/o feeling like she has to take shorter, more frequent breaths. Dizziness also improved. Oxygen removed and observed about 2 hours after incident. Patient requested to go home with family. Gave ER precautions and advised emergent evaluation/management.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,None,None,None,,No known allergies,"['Chest discomfort', 'Dizziness', 'Dyspnoea', 'Epinephrine', 'Immediate post-injection reaction', 'Nausea', 'Oxygen therapy', 'Respiratory rate increased', 'Throat irritation', 'Vomiting']",2,MODERNA,IM 919708,MI,41.0,F,Left hip pain,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/03/2021,1.0,PUB,None,None,None,,None,['Arthralgia'],1,PFIZER\BIONTECH,IM 919709,TX,34.0,F,"Within 24 hours headache that lasted > 48hrs. On Friday: nausea, diarrhea (severe), muscle aches, chills, fatigue, runny nose. On Saturday I woke with myself and my sheets soaked in sweat and dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,WRK,Pristiq,,Depression,,"Banana, latex, norco","['Chills', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Nausea', 'Rhinorrhoea']",1,MODERNA,IM 919710,CA,29.0,F,"Headache, chills, nausea, diarrhea, neck pain, fatigue, sweating for past 48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/03/2021,2.0,PVT,None,None,None,,None,"['Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Nausea', 'Neck pain']",1,MODERNA,IM 919711,CA,44.0,M,"5-6 post vaccination, blocked eustacian tubes and ringing in ear. Lasts for 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,01/01/2021,31.0,OTH,Atorvastatin,None,High cholesterol,,None,"['Eustachian tube obstruction', 'Tinnitus']",UNK,MODERNA,IM 919712,VT,59.0,F,"Half an hour after receiving vaccine in left arm, my left face started with a tingling, numb feeling like when you get anesthesia from a dental procedure and it is thawing out. It was just the left side of my face, same side I got the vaccine. Could feel a dividing line in the middle of my face. It lasted with the same intensity for 3 days. It then started to subside slowly for the next 3 days and then was totally gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Losartan, amlodipine, multivitamin",None,High blood pressure,,None,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 919713,MA,28.0,F,12/31/2020 to 01/03/2021 = Fever of 39�C for 3 days (12/31/20 to 01/02/20); Chills; Joint Pain; Severe Fatigue; Headache; Muscle Pain; Note: NO RESPIRATORY SYMPTOMS. 01/04/2021 = No fever; Continued Severe Fatigue; Continued Headache; Continued Joint Pain; Note: all other symptoms resolved (see above / listed previously).,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Medication (has remained stable for the last 12 months): Birth Control Pills, ADHD medication.",No illness for 12 months prior to vaccine.,None.,,None.,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test']",1,MODERNA,IM 919714,MA,50.0,F,MODERNA COVID-19 vaccine EUA raised itchy raised rash at injection site delayed reaction first noted 1/4/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/04/2021,8.0,OTH,VIT D daily,none,none,,none,"['Injection site rash', 'Rash papular', 'Rash pruritic']",UNK,MODERNA,IM 919715,NJ,66.0,F,"Nausea, vertigo, slightly blurred vision, imbalance walking, fatigue, heartburn, malaise. Initial vertigo and dizziness lasted 3 hrs. GI symptoms and malaise are still present, 48 hrs later",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/03/2021,1.0,OTH,"Pravastatin, 40 mg, OsteoBiFlex, Vit B Complex, Calcium Citrate, (as Theracal),","Chronic headaches, related to neck pain","Osteoarthritis, hyperlipidemia",,"Ancef, Ilosone","['Dizziness', 'Dyspepsia', 'Fatigue', 'Gait disturbance', 'Malaise', 'Nausea', 'SARS-CoV-2 test negative', 'Vertigo', 'Vision blurred']",UNK,MODERNA,IM 919716,AK,28.0,F,"headache, body aches, chills. Took Tylenol and headache improved but came back the next day. Continued to take Tylenol PRN with relief.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,UNK,None,None,Chronic Headaches and Migraines,,Amoxicillin and Penicillin,"['Chills', 'Condition aggravated', 'Headache', 'Pain']",1,PFIZER\BIONTECH,IM 919717,MA,51.0,F,"Extreme soreness at injection site within 4 - 5 hours, stiffness in arm. By next morning the soreness had spread to armpit, breast, and ribcage on left side of body. High level of pain/soreness remained for 3 days before subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,Adderall,,,,"Sulfa, Latex, Dairy, Gluten","['Axillary pain', 'Breast pain', 'Injection site pain', 'Musculoskeletal chest pain', 'Musculoskeletal stiffness']",1,MODERNA,IM 919718,CA,57.0,F,"Pain and swelling at injection area which is continuous. less painful today and swelling decreasing. Can not lie on left side at all. General Aches and joint pain all over body which is continuing over 4 days. fatigue. Mild diarrhea, nausea. loss of appetite have taken ibuprofen each day. took tylenol on saturday. No fever",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,WRK,"Vit D3, Krill oil 500mg, probiotic",none,none,MMR 2010,"sulfa, levaquin,pcn,blackberries,","['Arthralgia', 'Decreased appetite', 'Diarrhoea', 'Fatigue', 'Injection site pain', 'Injection site swelling', 'Nausea', 'Pain']",1,MODERNA, 919719,TX,49.0,F,"Itching, rash and redness through out body.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,MIL,"Hydrochlorothiazide, Diovan",None,Hypertension,,Iodine,"['Erythema', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 919720,TX,38.0,F,High fever about 6 hours after administration. 24 hours after administration loss of taste and smell. 48 hours after administration i tested positive for COVID-19.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/02/2021,1.0,PHM,"Vitamin c 250mg, multivitamins with zinc, vitamin d 2000",None,None,,None,"['Ageusia', 'Anosmia', 'COVID-19', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 919721,IA,46.0,F,"Tingling in lips 10 minutes after shot administered. Progressive numbness and mild drooping to right side of face (cheek, jaw, chin, neck, tongue, throat). Numbness in right arm down to 3rd, 4th and 5th fingers. Full function was still intact.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,None,None,None,,"Chocolate, INH","['Facial paralysis', 'Hypoaesthesia', 'Paraesthesia oral']",UNK,MODERNA,SYR 919722,IL,37.0,F,Left sided axillary lymphadenopathy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,PVT,"Ibuprofen after symptoms started,",None,None,,None,['Lymphadenopathy'],1,MODERNA,IM 919723,FL,36.0,F,"Temp 100.4,dry cough, headache, body aches, fatigue, runny nose started 1-2-20 started dexamethasone, zpack Pepcid vit c vit d zinc aspirin",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,,,SEN,Strettera 60 mg daily and ambien 10 bedtime,None,"ADHD, insomnia, sessional allergies",,None,"['Body temperature increased', 'COVID-19', 'Cough', 'Fatigue', 'Headache', 'Pain', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,IM 919724,MS,31.0,F,"After I received my initial vaccine, i couldn?t quench my thirst. The next day the pain from my endometriosis was horrific. Slight movement was excruciating",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,WRK,"Adderall, birth control, lexapro",Endometriosis,"Endometriosis, chronic fatigue, migraines",,"Pollen, noproxen, tomatoes","['Pain', 'Thirst']",1,MODERNA, 919725,TX,53.0,M,Soreness at injection site for 4 days. Also itches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/31/2020,30.0,WRK,"Multi vitamin, vitamin D3, Vitamin C",Sore throat one month prior,No,,None,"['Injection site pain', 'Injection site pruritus']",1,MODERNA,SYR 919726,MO,36.0,F,"Swollen, hot, reddened arm below the injection site- started 1 week post injection. Ice/cold packs, NSAID, and antihistamines administered. Continue to monitor at this time as still symptomatic",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/03/2021,7.0,PVT,none,none,pre-diabetic,This year's flu shot in October was administered too low and caused similar reaction on opposite arm within day or 2 post vacci,bactrim amoxicillin levemir,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 919727,PR,68.0,F,"RED, SWOLLEN AND HOT AREA (ARM).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,OTH,NO.,NONE.,HIGH BLOOD PRESSURE HYPO THIORIDAZINE,,NO.,"['Erythema', 'Inflammation', 'Peripheral swelling']",UNK,MODERNA, 919728,MS,44.0,F,"Redness,swelling and itching of 5cm radius to injection site 7 days after taking the 1st dose of vaccine at approximately 8:30 AM.Given keflex 500mg twice daily for 10days.Instructed to apply ice to reddened area as needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,PVT,"Levbid 0.375mg,crestor 5mg,Zoloft 25mg",None,"IBS,hyperlipidemia",,No know allergies,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 919731,TN,29.0,F,"Moderna COVID-19 Vaccine Large area of redness at the injection site. Area is raised from the skin and warm to the touch (looks like a large hive). Noticed itching of the skin earlier in the day, prior to discovery of the red area.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,OTH,"Women?s Multivitamin Probiotic Hair, Skin, & Nails Vitamin",,,,Medication allergies: sulfa & penicillin,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 919732,TX,29.0,M,"12/25/2020 quarter size knot, redness and warmth at injection site 12/27/2020 resolved with warm compresses 12/31/2020- injection site very tender, red, warm to touch, itching, burning, hardened size of 5cm circle 1/1/2020- symptoms persisted 1/2/2020- symptoms persisted 1/3/2020- symptoms resolved with application of hydrocortisone cream",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,PVT,NP thyroid,Strep throat 12/16,None,,None,"['Injection site erythema', 'Injection site nodule', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 919733,KS,36.0,M,"I am a board certified infectious diseases pharmacist and I have given lectures over hypersenstivites reactions. I noticed itching at the injection site a little more than 72 hours s/p injection with some minor itching. This progressed over the next 20 - 40 minutes to severe itching with large erythematous rash to the the left axillary region, then shoulder, and chest. Then hives developed pretty aggressively to majority of body including neck, back, inner thighs, and bilateral legs. The next morning I woke up to severe myalgias feeling like I was hit by a truck with soreness this resolved after roughly 24 hrs. Pain worse in buttocks, quadriceps, and sharp left lower mandible pain. On 01/02 around 7:30 pm took Hydrocorticone 100 mg PO x 1 and 50 mg of diphenhydramine q4h and the allergic reaction resolved over the next several hours. Still having upper torso itching going on 3 days after allergic reaction and 6 days after injection. Continued diphenhydramine 25 mg twice daily keeps the itching tolerable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/02/2021,3.0,PVT,None,None,,,Wheat allergy,"['Hypersensitivity', 'Injection site pruritus', 'Injection site reaction', 'Musculoskeletal pain', 'Myalgia', 'Pain in extremity', 'Pain in jaw', 'Pruritus', 'Rash', 'Rash erythematous', 'Urticaria']",1,MODERNA,IM 919734,VA,31.0,M,"Headache, relieved by nsaid and caffeine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,None,None,None,,None,['Headache'],UNK,MODERNA,IM 919735,MI,38.0,F,Hives noted on chest. Took 25mg po benedryl and hives were resolved within 3 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Subutex, adderall, ibuprofen, symbicort, albuterol",None,None,,NKA,['Urticaria'],1,PFIZER\BIONTECH,IM 919736,WA,70.0,F,"Chill, Fever 99.5*F, Muscle aching",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,"Metformin 1000mg, Atorvastatin 14mg, Januvia 100mg, Alendronate Sodium 17mg, Caltrate 600mg, Vitamin D3 2000mg, Biotin 5000 mcg, Gabapentin 300mg, Tumeric 1000mg",Acute left leg pain,"Type 2 diabetes, Osteoporosis, High Cholesterols, Osteoarthritis, Asthma, Arthritis",,Boniva (Ibandronate),"['Chills', 'Myalgia', 'Pyrexia']",1,MODERNA,SYR 919737,CO,56.0,F,"I had an itch on the left shoulder, not specifically at the vaccination site, after I scratched the shoulder I immediately had a welt the size of a quarter at the vaccination site. It was slightly raised, red, warm to the touch, and itchy. After an hour of no change I took OTC allergy pill. Symptoms resolved by later in the day though the vaccination sight continues to feel tender.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,01/01/2021,31.0,PVT,Tylenol 500mg x2 taken morning of vaccination,none,arthritis,,"Ropivicaine, Percocet, ACD-A, seasonal allergies","['Injection site erythema', 'Injection site pruritus', 'Injection site urticaria', 'Injection site warmth', 'Pruritus']",1,MODERNA,IM 919739,MS,37.0,F,"Rash All over stomach, buttocks and legs",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/02/2021,1.0,PUB,Rexulti. Lamictal. Valium. Ozempic. Vitamin D. Vitamin B12. Pepcid. Valsartan-HCTZ,N/a,Diabetes and high blood pressure,,N/a,['Rash'],1,MODERNA,SYR 919740,NC,24.0,F,"I, as the patient, as of 8:00 PM 01/03/21 began to have left shoulder pain around the clavicle area. Around lunch today (01/04/21) I was moving my neck around and when I move it to the left it rolls over something. I began to feel around the area and noticed that where the sore area is I have a rather large knot. It is a hard knot that is very tender and sore. No other signs and symptoms present. I have not been to a doctor or clinic regarding the issue. I was unsure if this issue was directly related with the vaccine or not.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,PUB,None,None,None,,None,"['Induration', 'Injection site pain', 'Musculoskeletal discomfort', 'Nodule', 'Tenderness']",1,MODERNA,IM 919741,NJ,67.0,F,"On my way home from receiving the vaccine, I felt slight numbness in my lips (no further swelling, etc.). Noticed some circumoral cyanosis around my lips after arriving home. Had a fine afternoon (sleeping following vaccine and 16 hr. shift). Had dinner and usual evening. Upon going to bed about 11pm, I experienced chills for several hours, and shortness of breath. Very weak. Called 911 about 3 am - went to hospital ER - O2 sat. 90% enroute. Vital signs stable in hospital ER. Had neg. CXR, EKG, and labs. Also had slight cough and slight bronchial congestion. Received some IV fluids in ER. Left ER at 7am. Went home and slept all day, slight nausea in am. Awoke at 7pm - had good breakfast for dinner. Fine evening and night. Off the next day from work - usual day. It was like having Covid all over again (positive X2 in April - out of work for 5 weeks). Although the symptoms began about 12 hrs. following the injection and subsided about 24 hrs. later). My colleagues (work as a nurse in long term care - rehab) who had Covid in the past have experienced similar symptoms following the vaccine, even though we had Covid back in the spring. Dreading vaccine number 2 on Jan. 19th - hopefully I will be ok.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,SEN,Metoprolol succinate 12.5 mg. several times weekly Levothyroxine 25 mcg. every other day alternating with 37.5 mcg. every other day Baby Aspirin 81 mg. daily Stresstabs with zinc daily Ibuprofen 200 mg. daily,None,hypothyroidism (mild) SVT,,Allergic to mycin drugs (ototoxicity) and Tamiflu (rash),"['Asthenia', 'Chest X-ray', 'Chills', 'Cough', 'Cyanosis', 'Dyspnoea', 'Electrocardiogram', 'Hypoaesthesia oral', 'Nausea', 'Oxygen saturation decreased', 'Pulmonary congestion']",1,PFIZER\BIONTECH,IM 919742,KS,41.0,F,1. R arm pain (severe)-couldn't lift arm or pull up clothes 2. Fever x 36 hours max: 101.0F 3. Chills 4. Rash generalized-did take zyrtec and benadryl for itching 5. Headache 6. Nausea 7. Fatigue 8. Body aches 9. Slept off and on for 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,Dyazide and Losartan-HTN Zolpidem-Insomnia Tylenol-as needed Flexeril-at bedtime muscle spasm,Covid 19-COVID + 12/7/2020,Lyme Disease with chronic muscle fatigue and aches-well controlled HTN-well controlled on oral medications,,Sulfa-rash and facial/lip swelling,"['Chills', 'Fatigue', 'Headache', 'Mobility decreased', 'Nausea', 'Pain', 'Pain in extremity', 'Poor quality sleep', 'Pruritus', 'Pyrexia', 'Rash']",1,MODERNA,IM 919743,CA,50.0,F,"Cough began approx 5 min post vaccine, then pt experienced flushing of neck, chest tightness and SOB. Placed on O2 mask at 8L/min, given 1 dose of Epi and transferred to ED",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,PVT,,,,,,"['Chest discomfort', 'Cough', 'Dyspnoea', 'Flushing']",1,MODERNA,IM 919744,TX,40.0,F,"Approx. 3 hours after being vaccinated. Developed confusion, dizziness, and blurred vision. Went to ER. BP noted to be 163/100. After one hour and a half, BP in the 120's systolic and 90's diastolic. Continued to have blurred vision. Blood pressure became labile and continued to be in the range of 160's over 100's to 130/90's. After 48 hours, vision no longer blurred, Blood pressure returned to normal baseline and maintained. Took BP for over one week after, morning, noon, and night on the Left arm and Right arm. My BP stayed in the 117/70-120/80 range. Wanted to make sure I had no underlying hypertension. No other adverse issues.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,Protonix 40 mg PO daily Pepcid AC PRN Viorele Birth Control,Gastritis/ Acid Reflux,Gastritis/GERD,,NKDA,"['Blood pressure abnormal', 'Computerised tomogram normal', 'Confusional state', 'Dizziness', 'Electrocardiogram normal', 'Full blood count normal', 'Labile blood pressure', 'Metabolic function test normal', 'Troponin normal', 'Urine analysis normal', 'Vision blurred']",UNK,PFIZER\BIONTECH,IM 919745,,39.0,M,developed hives on chest and arms with light headedness. Epi given x1 then transferred to ED,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,PVT,,,,,NKA,"['Dizziness', 'Urticaria']",1,MODERNA,IM 919746,TX,59.0,M,One day after vaccination the patient reported swelling to his tongue and was given Benadryl 25mg IM at 0930 and later that day he reported body aches and received Tylenol 650mg PO at 1450. The patients symptoms resolved on follow-up 1 hour after administration.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,TYLENOL 650mg Q6H PRN MYLANTA 30mL Q6H PRN AMANTADINE 100mg TID COLACE 100mg TID PROSCAR 5mg Qdaily MOM 30mL Q8H PRN MELATONIN 10mg QHSdaily ZYPREXA 7.5mg QHSdaily PRILOSEC 40mg Qdaily HYPOTEARS 1dryp Q6H PRN FLOMAX 0.4mg BID,"Arrhythmia with pacemaker, traumatic brain injury r/t fall, seizure r/t alcohol withdrawal, hepatitis, heartburn, prostatitis","Arrhythmia with pacemaker, traumatic brain injury r/t fall, seizure r/t alcohol withdrawal, hepatitis, heartburn, prostatitis",,NSAIDs,"['Pain', 'Swollen tongue']",1,MODERNA,IM 919747,CA,58.0,F,"15- 20 min following injection - heaviness in chest, 2-3 hours later - became flush, elevated blood pressure 169/92, pulse 100. Increased difficulty breathing.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,"Atorvastatin 20 mg 1 q day, Estradiol (polyglycol) (cmpd) 2.5 mg troche, amlodipine-benazepril 10-40 mg 1 q day; Allegra 180 mg 1 q day; Omeprazole DR 40 mg 1 q day; Vit D (2) 5000 I.E.U.; Krill Oil; COQ10","High blood pressure, high cholesterol",Asthma,,"Diovan, hydrochlorothiazide, aspirin, erythromycin, bee stings, adhesives","['Blood pressure increased', 'Chest X-ray', 'Chest discomfort', 'Dyspnoea', 'Electrocardiogram', 'Flushing', 'Laboratory test']",1,PFIZER\BIONTECH,IM 919748,NC,63.0,F,After 10 mins dry mouth occurred. After 15 mins compulsive swallowing occurred and dry mouth continued. Blood pressure elevated. Observation of swelling then 2 Benadryl were given. BP monitored. After about 15 minutes or longer swallowing slowed down some. BP did start coming down. A friend came to get me and I took 2 more Benadryl about 4 hours later due to swallowing issues again. After about 6 hours after that took more Benadryl and the the next 2 days just as needed about every 8 to 10 hours Started chills with highest temperature was 99.4. K Legs felt heavy the morning after the vaccine and I felt very tired with some short bursts of Nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/04/2021,5.0,PUB,"Vitamin D, one a day multiple vitamins",None,None,1977 Swine flu vaccine. Within a few hours very weak legs and some lethargy. Went to infirmary. After had fever and aches for,"Penicillin, Tequin","['Blood pressure increased', 'Body temperature increased', 'Chills', 'Dry mouth', 'Dysphagia', 'Fatigue', 'Limb discomfort', 'Nausea', 'Swelling']",1,MODERNA,SYR 919749,CO,47.0,F,"9 days after getting the vaccine, my arm is red, swollen, warm and the skin is hard in a circle around the injection site approximately 3-4 inches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/04/2021,9.0,PVT,"Spironolactone, venlafaxine",None,None,,None,"['Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 919750,PR,60.0,F,Induration redness rubor pain and itching left arm until seven days before administration,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PHM,Not,Not,CRPS,,Iodo for contracted,"['Erythema', 'Induration', 'Inflammation', 'Pain in extremity', 'Pruritus']",1,MODERNA,IM 919751,KY,44.0,F,"Injection site swelling, redness, rash and heat lasting since time of injection (~2 weeks).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,PVT,Metoprolol Succinate ER Atorvastatin Hydrochlorothiazide Sertraline Famotidine Tri-Vylibra Olopatadine nasal solution Multivitamin,,Heart murmur High blood pressure Hypercholesterolemia Anxiety,Injection site reaction to annual Flu Immunization,Latex Penicillin,"['Injection site erythema', 'Injection site rash', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 919752,LA,39.0,F,"I developed immediate flushing, sweating, rapid heartbeat (was around 110bpm, is normally around 75bpm), and lightheadedness. I sat down and had a few sips of water. Within a few minutes, I felt like I was having a difficult time getting a good breath in. I raised my hands over my head and took slow deep breaths to try and keep my breathing under control. I stayed at the hospital for about 45 minutes, over which time I had a few bites to eat and some water. The flushing and sweating resolved within that time. The lightheadedness and ""feeling of doom"" lasted about 3 hours. I had no anxiety going into this vaccine, nor have I had a reaction like this before.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,Synthroid,none,hypothyroid,,none known,"['Anxiety', 'Dizziness', 'Dyspnoea', 'Flushing', 'Heart rate increased', 'Hyperhidrosis', 'Immediate post-injection reaction']",1,PFIZER\BIONTECH,IM 919753,GA,31.0,F,"1 week after receiving the vaccine in the right arm, lymph node in the right arm pit became swollen and painful. Also, right upper chest lymph node swelling and pain. Continuing to have vague/dull pain in right upper arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,12/30/2020,6.0,WRK,"Multi-vitamin, fish oil",No,No,,No,"['Full blood count', 'Injection site pain', 'Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 919754,CA,27.0,F,"Patient started develop itchy rash on arm near injection site. The diameter of the rash was about 4 inches and developed in about 20 minutes after injection. We gave her an ice pack to apply over the area and a tablet, crushed of Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,SEN,,,,,,"['Injection site rash', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 919755,MA,24.0,M,"Fatigue at around 5pm. Chills at around 8 pm, with an underlying sense of head warmth. Fever at 9:45 pm with a headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,None,None,None,,Shellfish,"['Chills', 'Fatigue', 'Feeling hot', 'Headache', 'Pyrexia']",1,MODERNA,IM 919756,FL,27.0,F,"About 30 post administration, I had injection site soreness which progressively worsened in severity as time went on. About 12 hours after the injection I had a pretty sudden onset of fatigue, headache and nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Fatigue', 'Headache', 'Injection site pain', 'Nausea']",1,MODERNA,IM 919757,AZ,61.0,F,Lips and left side of face numbness and tingling about 10 minutes after first dose of Pfizer COVID-19 vaccination. Started first on the lips and then spread to left side of face and continued for 45 minutes to an hour after vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,"Toprol XL, Crestor, Glucophage, Levoxyl, Cozaar, Ergocalciferol, Ecotrin",None,"Coronary Artery Disease, Atherosclerosis, Hyperlipidemia, Adult Onset Diabetes Mellitus, Heart Stent Placement Status Post Myocardial Infarction, Morbid Obesity, Hypertension, Hypothyroidism",,None,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 919759,PR,53.0,F,after 8 day a erithema in the are appears.. warm palation and endure .. feeling ok within normal limits At 9 day disapear.. took Benadril cream and started Cefalexin ( antibiotioc) At 11 day a rash ocurred on site .. elevates puritis and redness.. call Dr and staret Decadron / chang antibiotic to Azitromax.. wird sensation of the tongue .. sweeling.. enlarged papilae.. tngling sensation around face snd lips.. .. feeling ok within normal limits,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,OTH,nono,none,none,,iodine,"['Erythema', 'Hypertrophy of tongue papillae', 'Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Palpitations', 'Paraesthesia', 'Paraesthesia oral', 'Skin warm', 'Swollen tongue']",UNK,MODERNA,SYR 919760,NY,52.0,M,"I tested positive for Covid-19 on 8/10/20. Symptoms were moderate (No hospitalizations/oxygen/interventions. Just flu like symptoms with significant chest pain. MI & PE ruled out in two ED visits, symptoms last about a month). Moderna Covid-19 Vaccine on 1/2/21 at 7:45 am. Developed significant chills at about 8:00 pm that evening. By 10:30 pm, chills, rigors, bodyaches, & fatigue (no fever). 1/3/21: Significant fatigue, chills, bodyaches, and now headache. Essentially stayed in bed the whole day; completely useless. Symptoms improved throughout the day. Was about 45% better by bed time. Severe diaphoresis in the middle of the night. 1/4/21: 75% better. Went to work and completed my shift. 95% better by the end of my shift.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Night sweats', 'Pain']",1,MODERNA,IM 919761,TX,60.0,F,My arm had been fine for the first 7 days. This morning I ran a wash cloth over my left arm and felt immediate discomfort. I looked in the mirror as soon as I got out of the shower and I could see that my arm had a large red area at the infection site. My arm is warm too touch. the rash measures 9.5cm by 7.5,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/04/2021,8.0,OTH,RALCXIFENE HCL 60 MG 2 X A DAY METFORMIN HCL 500 MG 2 X A DAY IBUPROFEN 600 MG 2 X A DAY CEPHALEXIN 500 MG 2 X A DAY,"No illnesses other than Diabetes Type 2 prior, but about 4 days later I sought treatment for a minor infection on my foot. I was put on the antibiotic and ibuprofen.",Diabetes type 2,,NONE,"['Injection site erythema', 'Injection site rash', 'Pain in extremity', 'Skin warm']",1,MODERNA, 919762,NY,35.0,F,Severe fatigue 2 hours after the shot lasting for 36 hours. Pain throughout the upper arm that received the injection lasting for 36 hours treated with Advil.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,None,None,None,,None,"['Fatigue', 'Injection site pain']",1,PFIZER\BIONTECH,SYR 919763,FL,22.0,M,Developed fever of at around 3AM and then fever went up to about 102 Degrees at 4AM. At 8 AM the fever was 100 degress and had also added a headache. The fever went down slowly and broke around 1PM.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,OTH,,,,,,"['Headache', 'Pyrexia']",1,PFIZER\BIONTECH,IM 919765,FL,72.0,F,"Abdominal pain and distention 48 hours after injection, w/o nausea or vomiting. Symptoms moderate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/03/2021,2.0,PUB,Rosuvastatin 40 Buspirone 5 mg,none,"none. History of anaplastic large cell lymphoma, currently NED.",,none,"['Abdominal distension', 'Abdominal pain']",UNK,MODERNA,IM 919766,NH,27.0,F,"dime size reddish bump, warm to touch",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,01/04/2021,9.0,MIL,"citalopram, bupropion xl, sprintec, spironolactone, trentinoin, omeprazole",,,,latex,"['Rash erythematous', 'Skin warm']",1,PFIZER\BIONTECH, 919767,SC,39.0,F,"Severe hives all over body- trunk of body fully covered in raised, red, blotchy, ""firey"" patches of hives; also, under armpits, over the shoulders, panty lines, behind knees, on and under breasts, back, onto neck and face (chin, lip area, eye brow area)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,PVT,Bupropion 300mg XR Trintellix 5mg,None,None,,Gluten sensitivity,"['Erythema', 'Rash macular', 'Skin swelling', 'Skin warm', 'Urticaria']",1,PFIZER\BIONTECH,SYR 919768,,23.0,F,Pt received Moderna COVID19 vaccine on 28 Dec 2020. Pt developed red area on left arm that became progressively larger. Patient reports no shortness of breath or difficulty breathing after vaccination. Pt went to ER to be evaluated and returned to clinic after visit. Red area measured 68cm and warm to touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,MIL,Unknown,,,,No Known Drug Allergies,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,IM 919769,CA,34.0,M,"Fever (max temp 38.7C), chills, myalgias, fatigue, sweats. Symptoms began 10 hrs after vaccination and lasted until 36 hrs after vaccination. Unable to work the following two days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,None,"COVID19 infection, date of symptom onset 12/16/2020 and date of positive test 12/17/2020",None,,None,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Impaired work ability', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 919770,ND,39.0,F,"13 days post vaccine, woke with small area of erythema around injection site, spread throughout day and now indurated, tender and warm to touch. No fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/04/2021,13.0,PUB,Probiotic Vitamin D3 2000IU,None,None,,None,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 919772,NC,57.0,F,"Pfizer-BionTECH Covid-19 Vaccine EUA Patient reports headache beginning approximately 2 hours after vaccination and present continuously since vaccination date (12/21/20) to date of report (1/4/21). She notes that is has been present constantly and is worse at times but is not relieved despite use of ibuprofen, acetaminophen, naproxen, Excedrin Migraine, or eletriptan 40 mg dose. She states that this headache is similar to the headache she had with previous Covid infection in March 2020 and July 2020, which also was not relieved with any medications that she tried. Also reported heart palpitations awakening from sleep on 12/30/20. Advised to seek medical care from primary care provider. On 1/4/21 patient states that she believes headache is improving but is not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,PVT,unknown,No known illnesses at time of vaccination. Patient states she has had Covid twice - once in March 2020 and once in July 2020.,,,unknown,"['Headache', 'Palpitations']",1,PFIZER\BIONTECH,IM 919773,MI,36.0,F,12/31/20 Severe dizziness with vertigo and loss of balance with any movement accompanied by nausea. 1/1/21 headache along with previous symptoms. 1/2/21 symptoms better with a little bit of dizziness with walking or bending over.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/31/2020,3.0,PVT,"Buspar, trulicity, prilosec, vitamin d",None,"Diabetes type 2, depression, anxiety",,None,"['Balance disorder', 'Dizziness postural', 'Headache', 'Nausea', 'Vertigo']",1,MODERNA,IM 919774,IL,59.0,F,"I experienced numbness of my chin and lips. Also, I had stiffness of my jaws. I was given a Zetec (allergy Tablet PO) and monitored for 1 hour, with vital signs being taken.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,"Metformin, amlodipine, hydrochlorothiazide",None,"Bronchitis, Htn, DM",,Losartan and doxycycline,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Joint stiffness']",1,PFIZER\BIONTECH,IM 919775,OR,23.0,F,Hives all over legs and wrists. Itchy and red bumps,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,PVT,No,No,No,,Cows milk sensitivity,"['Rash erythematous', 'Rash pruritic', 'Urticaria']",1,MODERNA, 919778,FL,37.0,M,"Body aches, chills, and extreme fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Taking Wellbutrin, vitamin B12, and vitamin D, all prescribed.",None,None,,None,"['Chills', 'Fatigue', 'Pain']",1,MODERNA,IM 919779,IL,50.0,F,"Pt received the Covid-19 vaccine at 2035. At approximately 2045, pt. reported feeling a slight swelling of her throat in the tonsillar region. She denied shortness of breath and difficulty breathing. She reported that her throat felt numb. At 2050: P: 69, SaP02: 96%, B/P: 110/75. Rapid Response team was called. RRT arrived at 2100 and patient stated symptoms remained unchanged. Pt. Transported to ED with RRT in wheelchair.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Pharyngeal hypoaesthesia', 'Pharyngeal swelling']",1,MODERNA,IM 919781,VA,33.0,F,1 week later large swelling at injection site and swelling of ipsilateral auxiliary lymph node,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,multi-vit,none,none,,none,"['Injection site swelling', 'Lymphadenopathy']",1,MODERNA,IM 919783,TX,26.0,F,"On 12/24 at around 10 PM, circulation to my 4th left digit significantly decreased after being outside of my car for around 15 minutes during a temperature of about 50 degrees. I realized when sharp pain was felt at the digit. After about 5 minutes the digit felt numb. I got in my car, turned on the heater, and massaged my finger. Sharp pain was felt again as circulation returned to the digit. The event last approximately 10 minutes from the moment I realized the finger was pale until color returned. This occurred again on 12/27 at around 2 PM as I walked from my car into a store at a temperature of about 40 degrees. This time, discoloration occurred bilaterally on my left 3rd, 4th, and 5th digits and my right 2nd, 3rd, 4th, and 5th digits. The event lasted more than 15 minutes with constant massaging. This has occurred two more times since then, both times occurring bilaterally with minimal exposure to cold.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/23/2020,12/24/2020,1.0,OTH,TriSplintec Oral Contraceptives,,Tortuous Colon,,NKDA,"['Hypoaesthesia', 'Pain in extremity', 'Pallor', 'Poor peripheral circulation', 'Skin discolouration']",1,PFIZER\BIONTECH,IM 919784,AZ,42.0,M,"Day 12.. still have chills, headache and fever of 101.5 every night.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,,,,,,"['Blood test', 'Chills', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH,IM 919785,WA,40.0,F,Toe went numb on right foot and next morning had a lot of swelling and cert painful under the foot. Whole top of foot and toe was really swollen and a lot bigger than the other couldnt walk or put pressure on my foot. Have been home unable to work since december 30th,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,WRK,None,None,None,,No,"['Gait disturbance', 'Hypoaesthesia', 'Impaired work ability', 'Pain in extremity', 'Peripheral swelling', 'Weight bearing difficulty']",UNK,PFIZER\BIONTECH,SYR 919786,TX,55.0,F,"having chill , fatigue and pain at injection site about 24 hrs after receiving COVID9 Vaccine ,took Tylenol 650mg and Ibuprofen 400mg. symptoms resolved after about 40 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,PHM,"multivitamins , Flaxseed capsules ,Zinc capsules",none,none,,none,"['Chills', 'Fatigue', 'Injection site pain']",UNK,MODERNA,IM 919787,OK,28.0,F,Extreme swelling and pain. Bubbling around injection site. Bruising all over body.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/02/2021,7.0,PVT,"Adderall, melatonin",,,,,"['Contusion', 'Injection site reaction', 'Pain', 'Swelling']",1,MODERNA,IM 919788,PA,34.0,F,"12/30/20 - fever of 101.6 degrees F 12/31/20 - fever of 100 degrees F, headache, congestion - tested for COVID-19 01/01/21 - fever of 100 degrees F, congestion 01/02/21 - congestion, partial loss of smell 01/03/21 - congestion, partial loss of smell 01/04/21 - congestion, partial loss of smell",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,Multivitamin,None,None,,Penicillin,"['Anosmia', 'Headache', 'Pyrexia', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,MODERNA, 919790,TX,38.0,F,Patient reported the day after vaccination that she had arm pain and received Tylenol 650mg on 12/31/20 at 0934 and later Zyrtec for allergies at 1010. Patient also reported two loose stools this day and reported no symptoms on 1/1/21.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,TYLENOL 650mg Q6H PRN MYLANTA 30mL TID PEPTO-BISMOL 2 tab QID PRN ZYRTEC 5mg Qdaily PRN PROZAC 65mg Qdaily ATARAX 25mg TID PRN DEPO-PROVERA 150mg IM Q3months CEPACOL LOZENGE Q4H PRN METFORMIN 500mg BID PRILOSEC 40mg QAMAC OXYBUTYN,"Osteoarthritis, DM","Osteoarthritis, DM",,None,"['Diarrhoea', 'Pain in extremity']",1,MODERNA,IM 919791,TX,64.0,F,"One week after vaccination, the injection site became itchy. Then the skin turned red, swollen and warm to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,PVT,"Atorvastatin, Vascepa, Losartan-HCTZ,",None,"Hypertension, hyperlipidemia",,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 919793,OR,23.0,F,Rash on arm started at injection site 6 days after injection and still continues on day 8. Rash is 1.5 inch diameter circle of red hives/rash,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/02/2021,6.0,PVT,"Wellbutrin, vitamin D",,Selective igA deficiency -autoimmune,,,"['Injection site rash', 'Rash', 'Rash erythematous', 'Urticaria']",1,MODERNA,IM 919794,TX,32.0,F,"Beginning 01/03/2021 irritation in lymph nodes in right arm. Beginning 01/04/2021, additional irritation in lymph nodes in right side of neck.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,PHM,None,None,None,,None,['Lymphadenopathy'],1,MODERNA,SYR 919795,WA,48.0,F,"10 days after injection, 3.5 cm round rash; erythematous and raised.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/04/2021,11.0,PVT,None.,None.,None.,,None.,"['Injection site reaction', 'Rash erythematous', 'Rash papular']",1,MODERNA,IM 919796,OK,33.0,F,Bronchoconstriction requiring use of rescue albuterol inhaler not previously needed for at least 5 years,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,SEN,"Singulair, Advair, Claritin",None,Asthma - well controlled for 20 years,,None,['Bronchospasm'],UNK,PFIZER\BIONTECH,SYR 919797,NY,26.0,F,Painful swollen lymph node on left supraclavicular lymph node,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,PVT,Tri-Sprintec (28),None,None,,None,"['Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 919798,TX,42.0,F,"30 minutes after vaccination: numbed left side of face Around 4 pm started with ringing ears, lightheaded . Light chest pain but not too bad to go to the ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Women vitamins,, vitamin D, fish oil,",None,High blood pressure,,None,"['Chest pain', 'Dizziness', 'Hypoaesthesia', 'Tinnitus']",1,MODERNA,IM 919799,TX,32.0,F,Swollen lymph nodes on left armpit and left side of neck. Ibuprofen taken for discomfort. No further actions needed at this time.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/04/2021,6.0,PHM,,,,"Hives at injection site, 29, MMR","Toradol, Duricef, MMR vaccine","['Discomfort', 'Lymphadenopathy']",1,MODERNA,IM 919800,MO,39.0,F,"2 hrs post injection sudden onset of severe dry mouth that lingered but gradually resolved. Still dry next morning and a couple hrs later it switched to increased salivation. The evening after injection I had a headache and just felt general malaise and fatigue, ""run down"". Difficulty sleeping that night due to body aches. HEadache, neck and lower back pain. Skin sensitivity when touched, bed sheets kinda hurt my skin. The bodyaches and malaise persisted through out day 2. Tylenol seemed to help. I slept better that night but woke up with night sweats, completely drenched. Arm pain at injection site on day 2 that resolved by mid day. Now 1 week later I have extreme fatigue yesterday and today. I do have hypersomnia but not even my adderall is helping. Not sure if this is related or not.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,Adderall,,Hypersomnia and ADD,,NKA,"['Back pain', 'Dry mouth', 'Fatigue', 'Headache', 'Injection site pain', 'Insomnia', 'Malaise', 'Neck pain', 'Night sweats', 'Pain', 'Salivary hypersecretion', 'Sensitive skin']",1,PFIZER\BIONTECH,IM 919801,WI,31.0,F,"Itching, diaphoresis, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Hyperhidrosis', 'Nausea', 'Pruritus']",UNK,MODERNA,IM 919802,TX,40.0,F,"Patient reported that the day after vaccine administration she had pain to her right arm (site of injection) and received Tylenol 650mg at 1450. The next day she reported the same pain and received Tylenol 650mg at 1510. On 1/2/21 she reported allergic reaction to the vaccine - her arm was noted to be red, warm to the touch and hard. She was given Benadryl 50mg PO at 0730 and medication was partially effective. On 1/3/21 she reported right arm pain and induration and warmth was noted.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PUB,Povidone-Iodine topical QdailyHS Bismuth 1 tab BID PRN Tylenol 650mg Q6H PRN Clotrimazole topical BID Mupirocin topical BID Flonase 1 spray BID PRN MiraLAX 17G BID Colace 100mg BID Prazosin 7mg QHS Melatonin 10mg QHS Atarax 50mg BID Clozapi,"Nasal allergies, arrhythmia, CAD, HTN, pacemaker, asthma, sleep apnea, DM, hypothyroid, obesity, constipation, GERD, paralyzed left arm from self inflicted scratches, MRSA history","Nasal allergies, arrhythmia, CAD, HTN, pacemaker, asthma, sleep apnea, DM, hypothyroid, obesity, constipation, GERD, paralyzed left arm from self inflicted scratches, MRSA history",,"Fish, ibuprofen, PCN, Sulfa, Tetracycline, Turkey","['Hypersensitivity', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 919803,NC,53.0,F,"Temp 102.2 the following morning (20 hours post-injection) with myalgia, fatigue. These symptoms resolved by 36 hours post-injection. Painful, red, swollen arm (injection site) then itching. These symptoms have improved but have not resolved completely (nearly 2 weeks post-injection)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,"Multivitamin, fiber supplement, Calcium supplement",,asthma,,"Dairy, eggs, wheat, spinach, bananas","['Body temperature increased', 'Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Myalgia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 919804,WI,24.0,F,"Itching, diaphoresis",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Hyperhidrosis', 'Pruritus']",UNK,MODERNA,IM 919805,AZ,30.0,M,"Rash at injection, bump at injection, soreness in muscle and when lifting arm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/04/2021,2.0,PUB,Benazipril,None,None,,None,"['Injection site rash', 'Injection site swelling', 'Myalgia', 'Pain']",UNK,PFIZER\BIONTECH, 919806,AZ,28.0,F,"Nausea no vomiting, chills, swelling and itchiness at injection site, warm to the touch, and sinus congestion",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/03/2021,8.0,PVT,,,Asthma-seasonal,,Pediazole-rash,"['Chills', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Nausea', 'Sinus congestion']",1,MODERNA,IM 921133,GA,22.0,F,"Mass vaccine clinic being held by Public Health at patients work location. Patient was initially monitored for 15 minutes but returned later at 14:53 with hives noted to abd, chest, and back area. Redness noted to arm at and around injection site. Patient presented digging at areas and reported itching. Vitals taken and due to presentation patient was given 50mg IM Diphenhydramine to L guteal area. Staff present continued to monitor and take vitals for an additional 30 minutes. Patients redness and largely reduced and not itching. Patient reports feeling sleepy. Left in care of charge nurse at facility. Spoke with charge nurse the next day to check on the patient and she reports that the patient said she slee slept very well but was feeling fine. PFIZERBIONTECH COVID-19 VACCINE EUA",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,UNK,,,,,,"['Injection site erythema', 'Pruritus', 'Somnolence', 'Urticaria']",1,PFIZER\BIONTECH,IM 921183,OH,61.0,F,Tinnitus in left ear,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PUB,"Multivitamin, Advil/Aspirin",,,,Naldecon 1980s,['Tinnitus'],1,MODERNA,IM 921430,MA,39.0,F,"Low grade fever, body aches, headache starting one day after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,Unknown,COVID + 2 mos ago,Unknown,,Unknown,"['Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,MODERNA,IM 922504,GA,56.0,F,MASS VACCINATION CLINIC BEING HELD BY PUBLIC HEALTH AT PATIENTS WORK LOCATION. PATIENT HAD BEEN OBSERVED AND RELEASE BUT RETURNED AT 15:21 WITH C/O ITCHING TO LOWER LEFT ARM. REDNESS NOTED IN THE SIZE OF ABOUT A HALF DOLLAR ON LOWER LEFT ARM.THIS NURSE ADMINISTERED 25MG OF PO DIPHENHYDRAMINE. PATIENTS VITIALS TAKE AND ADDITIIONAL OBSERVATION. PATIENT DID REPORT A HISTORY OF ALLERGIES TO COCONUT AND ASA ON CONSENT FOR (HIVES). PATIENT WAS LET WITH SUPERVISING NURSE FROM WORK. I CALLED TO CHECK ON PATIENT THE NEXT DAY AND PATIENT REPORTED THAT SHE WAS DOING FINE. PFIZERBIONTECH COVID-10 VACCINE EUA,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,UNK,,,,,,"['Drug hypersensitivity', 'Erythema', 'Food allergy', 'Pruritus']",1,PFIZER\BIONTECH,IM 922505,MI,47.0,F,"Friday 7 AM - Extreme Dizziness, fell over 2x Extreme fatigue, general malaise, Nausea 5 pm more awake, dizziness subsiding Sat 10am Dizziness Subsiding, general malaise, Nausea Sun Dizziness gone, Runny Nose, Stuffiness, full/congested feeling Mon 99.5, Nausea, Drainage",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,"Atorvastatin 40 mg Vit D - 50,000 IU Dulaglutide (Trulicity) 3 mg losartan 50 mg bid",Acute Vulvitis,"DM II Hypertension, Depression w/Anxiety Hyperlipidemia Morbid obesity",,"Penicillin, Lisinopril","['Dizziness', 'Fall', 'Fatigue', 'Malaise', 'Nasal congestion', 'Nausea', 'Respiratory tract congestion', 'Rhinorrhoea', 'Sinus operation']",1,PFIZER\BIONTECH,IM 922506,DC,43.0,F,30-45 min post vaccine administration I had severe headache and hives/rash,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PHM,Zyrtec 10mg Singulair 10mg,none,allergy induced asthma anemia,,"peas, nuts, latex","['Headache', 'Rash', 'Urticaria']",1,MODERNA,IM 922510,CT,65.0,M,"Pt received dose #1 Moderna COVID19 Vaccine Observed x 15 mins Left and went to his office where he exhibited ""pounding chest & cold hands"" Came back to clinic about 30 minutes after vaccine BP increased 180/100 HR 145 EMS called",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,,,,,Allergy hx (hayfever),"['Blood pressure increased', 'Palpitations', 'Peripheral coldness']",1,MODERNA,IM 922562,ME,58.0,F,"onset of HA, nausea, tingling in fingers and strange taste in mouth approximately 10 min after receiving the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['Headache', 'Nausea', 'Paraesthesia', 'Taste disorder']",1,MODERNA,IM 922576,GA,37.0,F,"Pt reports event started 12/30/2020 in the evening with a sore tender arm. Started with nausea & vomitting this AM around 10 AM. Reports one bout of vomitting. Also says body aches started this morning as well. Denies any SOB, difficulty brething or any serious adverse events. Says currently she is much better. Will F/U on 1/4/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,Tylenol Amolodopine 5mg QD,Elevated B/P,Denies,"Flu vaccine - reports symptoms as above, 36 y.o - unable to recall. Patient reports similar symptoms when vaccinated with the fl",Denies,"['Limb discomfort', 'Nausea', 'Pain', 'Tenderness', 'Vomiting']",1,MODERNA,IM 922582,UT,16.0,F,Not an adverse reaction. Medication Error Vaccine for 18 and older given to 16 yr old.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,,,PUB,unknown,none,none,,no allergies to vaccines,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 922616,MI,41.0,F,"Pt stated she experienced pain, redness at the injection site. She also has a lump measuring 5.5 cm at her injection site. it is ""hot"" to the touch. Pt also experienced a fever the following day after receiving her Moderna Covid Vaccine. Received Covid injection at 11:30 am and started having a reaction by 6:00pm on 12/31/20.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,None,"Pt tested Positive for Covid-19 Nov. 3, 2020",,,"['Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site warmth', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 922617,TX,53.0,F,"Pateint recieved COVID19 (Pfizer-BioNTech) vaccine on 12/30/2020 and statrted to develop a rash on hands and sole of her feet onsetting 01/01/2021. Per patient, she took OTC allergy medication and applied OTC Cortizone onto hands and feet. Pateint denies sypmptomes of headcaches, fever, diarrhea, or nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,Lisinopril 10 mg,None,Hyperlipidemia; Hypertension,,Penicillin,['Rash'],UNK,PFIZER\BIONTECH,IM 922618,NE,37.0,F,Right sided facial tightness pt states similar reaction to alcohol consumption. Moderna Covid 19 Vaccine Lot: 011L20A EXP: 07.03.2021 NDC# 80777-273-99,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,MVI omeprazole lamotrigine fluoxetine,arthritis anxiety acid reflux diabetes,"diabetes, Arthritis, anxiety, acid reflux",,morphine,['Skin tightness'],UNK,MODERNA,IM 922619,TX,47.0,F,"""tickle in throat"" - 2:41pm 25mg oral benadryl - 2:47 pm Sx resolved - 3:15pm monitored 45min - went home 4pm",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,PVT,taks losartan,HTN,HTN,,NKDA,['Oropharyngeal discomfort'],1,MODERNA,IM 922620,TX,,F,"pt received covid19 vaccine, complained of nausea & brain fog (cloudy) pt admited to ER with fever and increase in Blood pressure, midnight complained of tightness in chest (SOB). pt was released fr ER w/tylenol + ibuprofen+ zofran. While at home, pt complained of pain in hip, swollen arm, chill, Dr informed to rest + keep hydrate w/water, call 911 for help if symptoms worst or severe.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,PUB,unknown,"pt was ok, healthy",unknown,,,"['Arthralgia', 'Blood pressure increased', 'Chest discomfort', 'Chills', 'Dyspnoea', 'Feeling abnormal', 'Nausea', 'Peripheral swelling', 'Pyrexia']",2,PFIZER\BIONTECH,IM 922621,NY,51.0,F,Patient reported having alcohol wipe taste at the tips of her tounge 15 minutes post-vaccination. No other adverse reaction reported at This time. After assessing the patient. No other symptom or other serious adverse reaction reported. Pt in no distress,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,,,WRK,,,,,"kiwi, shellfish",['Taste disorder'],UNK,MODERNA,IM 940641,,34.0,F,Headache Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Headache'],UNK,MODERNA, 919807,,31.0,M,Fever to 103.4F for approximately 4 hours. Myalgias.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/05/2021,7.0,UNK,,,,,,"['Myalgia', 'Pyrexia']",1,MODERNA,IM 919808,CA,52.0,F,"within 20 of the injection I strted to salivate and feeling nauseated. returned to clinic and was monitor there. my blood pressure was noted to be low at 115/41. HR 74. reepat BP was 121/48 which is much lower than my usal BP. i was observed for about 1 hrs. the sx's did not go away but the BP improved a little to 130/64 standing. I went home develop injection site pain, fatigue, headache and the pesistent salivation did not go away. after 1 wk it decreased in frequency but still present today. I can not do my normal activity as this worsen the symptom. and my blood pressure has not normalized. still run in 110's/60's. the headaches and fatigue are becoming a burden.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,PVT,"ocella, synthroid, vit D, mobic, tylenol",,back and shoulder pain,,NKDA. food allergy vs sensitivity shrimp and dairy,"['Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Salivary hypersecretion']",1,PFIZER\BIONTECH,IM 919811,OH,32.0,F,7 days post injection developed significant hives and edema at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,Prenatal vitamins,None,None,,Anaphylaxis to bactrim,"['Injection site swelling', 'Urticaria']",1,MODERNA,IM 919812,CA,61.0,M,"Left antecubital rash and pruritic lasting last 5 days, self treated with hydrocortisone 2.5% cream two times partially relieving the pruritic and redness, but still present at time of report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,MIL,Lisinopril 40 mg po qd,None,"Hypertension, History of mild psoriasis",,None,['Rash pruritic'],1,MODERNA,IM 919813,OR,59.0,F,"At 17:00, the injection site started to itch and was warm to the touch. At 4:00 on 01/04/2021, I experienced extreme vertigo while washing my hands at a sink. I returned to bed to get the vertigo to pass, but then vomited at 4:30. I was extremely tired the remainder of the day, sleeping often and have been flushed all day as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,PVT,I refrained from Levothyroxine and supplements 24 hours prior to vaccination.,None,Asthma,,Morphine,"['Fatigue', 'Flushing', 'Injection site pruritus', 'Injection site warmth', 'Vertigo', 'Vomiting']",1,MODERNA,SYR 919814,NJ,55.0,F,"after the injection I became lightheaded and my blood rose to 155/94. after a hour both my pressure and lightheadness went away. on 1/1 I felt fatigue at work and the injection site began to hurt. On 1/2 I stood home and was still fatigue and had some tension in my neck area. On 1/3 began to feel better no pain at the injection site, no longer fatique, and no tension on my neck.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,WRK,"metformin hcl , metoprolol amlodipine besylate, trulicity",none,High blood pressure obesity diabetes,,"all nuts, all seafood","['Blood pressure increased', 'Dizziness', 'Fatigue', 'Injection site pain', 'Musculoskeletal discomfort']",1,MODERNA, 919815,CA,48.0,F,"15 minutes after patient received her #1 Pfizer vaccine, she started to feel flushed with some throat irritation. She states she feels "" a bit shaky inside "". Given juice and crackers. BP 143/84. heart rate 89. O2 sat 99%. She was moved into another quieter observation area. She claims she felt better. Given H20 to drink. States she had a bit of chest discomfort but this was nothing new to her. She has been having chest discomfort for the past 1-2 weeks periodically. Upon observing patient for 40 minutes, patient states, she felt better. BP 115/78, heart rate 80. Patient was then released. She states this is the first time this has happened while taking an IM injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,,Periodic chest tightness for 2 to 3 weeks possibly due to stress,,,,"['Chest discomfort', 'Flushing', 'Nervousness', 'Throat irritation']",1,PFIZER\BIONTECH,IM 919816,UT,44.0,F,"One hour post shot, heart beat went up to 120 at rest. Slight dizziness. This passed. Later in the evening compared injection sites with others in the household. Mine is redder, more swollen and seems more tender than others.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PUB,"Bupropion, topamax",None,Migraines,,"Penicillin, sulfa, Cipro, walnuts","['Dizziness', 'Heart rate increased', 'Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 919817,NE,19.0,F,"Fever, nausea, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,"Tylenol and Motrin; Singulair, Nexplanon implant",None,"Asthma, seasonal allergies",,NKDA,"['Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 919818,CA,33.0,F,"Received covid vaccine 1/2 at 2pm. Around 7pm that night, left arm pain and slight itching of whole body. did not think much of it. woke up once in middle of night at 4am with racing heart but went back to sleep. Around 9 am next morning started getting chills, initially mild then severe and developed severe myalgias; could not get out of bed or lift arms or limbs. having chest tightness and shortness of breath. pressing on chest wall hurts, hard to take deep breath. Temps of 99.5 most of morning. started taking tylenol total of 1 gram. 1 hour after tylenol shaking and rigors with sweating. had temp of 101 after tylenol. HR 110 at this time (my baseline is around 60s). O2 sat remained normal. Went to ER for testing for covid in case this was covid--test negative. Felt a little better morning of 1/4--no fever. tried to work 1/2 day; called out sick. lots of brain fog, fatigue mental slowing. still having intermittent chest tightness and sob; feel like i cannot expand my lungs. deep breath makes me cough. had few small red bumps on left antecubital fossa that resolved. i'm a physician, i'm concerned this was a severe reaction and was advised to report this.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PVT,none,none,none,"HPV vaccine, swelling of joints in fingers (dactylitis)--10/6/2013","Keflex, HPV vaccine","['Chest discomfort', 'Chills', 'Cough', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Heart rate increased', 'Mental impairment', 'Myalgia', 'Pain in extremity', 'Pruritus', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 919819,CA,49.0,F,"About 3 minutes after getting the injection, my heart rate elevated, I was dizzy and felt faint with some chest tightness. I told RN, the nurse who gave me the injection and I was told to lay down on my back and she lifted both of my legs perpendicular to the floor. My hands and feet were tingling. My blood pressure was taken and the first reading was elevated and hear rate was 102. I was given a can of apple juice and I felt better after drinking it. Since the blood pressure cuff was too large for me, I was able to go downstairs to urgent care and get a reading with a smaller cuff. The last BP reading was had lowered and I was able to leave. I did not feel well for a good 45 min. My left arm was very sore for the first 48 hours. It did not go away for at least 5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Zyrtec,None,Allergic rhinitis,,"latex, sulfa, quinolone, phenergan, reglan, promethazine, celebrex, augmentin, diclofenac, compazine","['Chest discomfort', 'Dizziness', 'Heart rate increased', 'Pain in extremity', 'Paraesthesia']",1,MODERNA,IM 919820,NY,39.0,F,"Injection sight pain and swelling, headache, fatigue, omalaise.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,UNK,,,,,Corn,"['Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Malaise']",1,MODERNA,IM 919821,AK,34.0,F,"I developed severe hives all over my body hours about 19 hours after the shot. Intense itching woke me up at 4:40am the day after receiving the vaccine. The reaction worsened for the next 3 days and began to settle/decrease at the end of the 3rd day. I also felt somewhat disoriented through the allergic reaction period, and on the day after the vaccine I felt slight pain on my chest. I did not experience shortness of breath or have trouble breathing at any point.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,OTH,"SSRI 20mg Anti-fungal medication, oral, for toe nail fungus",None,"Asthma , currently controlled",,None,"['Chest pain', 'Disorientation', 'Pruritus', 'Urticaria']",1,MODERNA,SYR 919822,FL,49.0,M,High grade fever with chills almost like rigors 103.8 F Happened after 9 pm Initially started with malaise Fever being monitored throughout the night,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Malaise', 'Pyrexia']",1,PFIZER\BIONTECH,IM 919823,NC,28.0,F,Numbness in right cheek of face almost immediately after injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,"Zoloft 25 mg, Vitafusion Women's multivitamin",,,,"Mango peel, fire ants",['Hypoaesthesia'],1,PFIZER\BIONTECH,SYR 919824,,23.0,F,"tiredness, headache muscle pain, chills, nausea, feeling unwell",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,tri sprintec dicyclamine,,,,coconut,"['Chills', 'Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Nausea']",UNK,PFIZER\BIONTECH,IM 919825,CO,31.0,F,"paleness, weakness, then a few hours later chills, fever, extreme pain at the injection site, body aches, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,nuvaring,,,,,"['Asthenia', 'Chills', 'Injection site pain', 'Malaise', 'Pain', 'Pallor', 'Pyrexia']",1,MODERNA,IM 919826,WA,43.0,M,"Soreness of deltoid resolved 2 days after vaccine. Normal shoulder for 7 days. Day 8 post vaccination onset of itching, swelling and redness of left should, continuing now x2 days. No other systemic symptoms. No pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/03/2021,8.0,PVT,None,None,None,,None,"['Erythema', 'Injection site pain', 'Pruritus', 'Swelling']",1,MODERNA,IM 919827,CA,45.0,M,Began experiencing nausea and general stomach pains the morning after receiving the vaccine. After one day of pain and discomfort I woke the following morning (~44hrs after receiving the vaccine) to extreme acute abdominal pain in the lower right abdomen. Went to Urgent Care facility and was diagnosed by CT scan as having acute appendicitis. An emergency appendectomy was scheduled and performed for later that evening. I stayed at the Hospital overnight on 12/24/2020 post operatively on IV antibiotics to recover from the appendectomy. Was discharged from the hospital on 12/25/2020 and have been recovering for about 10 days now with limitted activity.,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,none,none,none,,penicillin,"['Abdominal pain lower', 'Abdominal pain upper', 'Appendicectomy', 'Appendicitis', 'Computerised tomogram abdomen abnormal', 'Discomfort', 'Nausea', 'Pain']",1,MODERNA,IM 919829,OH,56.0,F,Fever 101.0,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,,,,,NKDA,['Pyrexia'],1,PFIZER\BIONTECH,IM 919830,PA,47.0,F,"At time of injection and for about 30 minutes after, had light tingling to left arm to fingertips, face flushed and warm. Resolved without intervention. No other side effects except muscle soreness to this arm. ( Wouldn't report but a coworker had a similar but more severe reaction and is still having effects 3 wks out)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,"tylenol, advil",none,osteoarthritis,,NKA,"['Feeling hot', 'Flushing', 'Immediate post-injection reaction', 'Myalgia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 919831,NY,25.0,F,"Patient reported swelling on the injection site, itchiness, warmth and soreness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,WRK,,unknown,unknown,,no known allergies,"['Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 919832,WA,28.0,F,"12/31, 08:30pm: Immediate pain & welt developed at sight 12/31, 08:45pm: Slight numbness & tingling in left hand, persisted approximately 12 hours 12/31, 09:30pm (the following s/s persisted in varying degrees until 01/02): exhaustion/fatigue, headache, dizziness, nausea, chills 01/02, 08:30am: chills/cold sweat/fever (temp not confirmed, as my home thermometer had died, but I woke up later that night drenched in sweat as though a fever had broken, and since then my body temp has been normal (no cold chills or hot flashes) and other s/s have also decreased significantly) 01/03: minimal s/s - lingering fatigue, mild 01/04: 03:00a: woke up with cough - uncertain if related (seasonal allergies?)",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PVT,Lamotrigine 150mg 1x/day Apri Birth Control CBD 30mg cap 1x/day Loratadine Allergy 1x/day,N/a,Scoliosis Bipolar II,,"Seasonal, mild","['Chills', 'Cold sweat', 'Cough', 'Dizziness', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Hypoaesthesia', 'Immediate post-injection reaction', 'Injection site pain', 'Nausea', 'Paraesthesia', 'Pyrexia', 'Urticaria']",1,MODERNA,IM 919833,IL,24.0,F,"Symptoms were chills, fatigue, body aches, headache, fever, tachycardia that started about 12 hours after receiving the vaccine and lasted for about 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Sprintec,,,,NKA,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia', 'Tachycardia']",1,MODERNA,IM 919834,NY,16.0,F,Age at the time of vaccination was 16. Not identified until after the vaccine was administered.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,12/24/2020,0.0,PVT,,None reported. Age 16 at the time of the vaccine. Not identified until after vaccination is complete.,,,,['Product administered to patient of inappropriate age'],1,MODERNA,IM 919835,IL,62.0,F,light headed and nausea for 3 days,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Dizziness', 'Nausea']",1,PFIZER\BIONTECH,IM 919836,,35.0,F,"10 minutes after receiving vaccination, patient reported rapid heart rate, fatigue, felt weak, hot, and palpitations. Patient reported tachycardia with heart rate 160-170's. Transient numbness to hands and perioral region. Presented to ED, was monitored with resolution of symptoms. On 1/4/21 patient presented to ED with tachycardia with HR up to 160s, Episode was severe, causing lightheadedness, ""throat squeezing"", with bilat UE paresthesias. Episode lasted 20 minutes. Patient evaluated in ED and discharged with outpatient follow up with cardiology and endocrinologist.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,"levothyroxine, progesterone, estradiol","Hashimoto's diagnosed age 17, on levothyroxine since 2019, dose increased 12/25/20",premature menopause age 27 on HRT,,"amoxicillin (hives), ampicillin (rash), ibuprofen (dyspepsia)","['Asthenia', 'Dizziness', 'Fatigue', 'Feeling hot', 'Heart rate increased', 'Hypoaesthesia', 'Palpitations', 'Paraesthesia', 'Tachycardia', 'Throat tightness']",1,PFIZER\BIONTECH,IM 919837,PR,60.0,F,Tight throat.Drank 1 pill benadryl.After few hours the symptoms were gone,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,"Losartan,Keppra",,"Epilepsy,High blood preassure",,"Aspirin,almonds,walnuts,shellfish",['Throat tightness'],UNK,PFIZER\BIONTECH,SYR 919838,MI,24.0,F,"less than 24 hours after getting shot #1 i felt as if i was coming down with a cold, very congested, stuffy nose, slight sore throat probably from drainage. injection site pain which is normal, but i just felt under the weather. it cleared up within 48 hours of time of injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,WRK,Zoloft 100mg Apri 28 day 1200mg Fish Oil HUM Daily cleanse skin supplement green algae and herbs 450mg Cranberry extract supplements,,Generalized and Social Anxiety IBS Chronic headaches hyperhidrosis hypoglygemia,,Lactose Intolerant Allergic to Cyanoacrylate Allergic to Cervical Cancer Vaccine,"['Drainage', 'Injection site pain', 'Nasal congestion', 'Oropharyngeal pain', 'Respiratory symptom', 'Respiratory tract congestion']",1,PFIZER\BIONTECH,SYR 919839,MD,62.0,F,"Cold legs, Fever, bodyache including fingers ache, chills, nausea, body weakness, headache. From Saturday to Tuesday. Tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,WRK,None,None,High blood pressure Diabetes,,None,"['Asthenia', 'Chills', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'Sensory disturbance']",1,MODERNA,IM 919869,IN,7.0,M,"anaphylactic reaction; This spontaneous report has been received from an approximately 57 years old male patient, referring to himself via Pfizer. The patient's concurrent conditions included an allergy to eggs. Medical history and concomitant medications were not provided. On an unknown date in 1970 (reported at the age of 7 years old), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. In approximately 1970, the patient experienced an anaphylactic reaction and required treatment with epinephrine. The patient worked in a long term care assisted living facility and was unable to obtain the mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose (COVID-19) vaccine (Pfizer-Biontech) due to the facility refused to vaccinate him after the patient divulged that he had the previously reaction with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine. The outcome of anaphylactic reaction was unknown. The reporter considered anaphylactic reaction to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II). Upon internal review, anaphylactic reaction was determined to be medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,Egg allergy,,,,['Anaphylactic reaction'],UNK,MERCK & CO. INC., 919870,,66.0,F,"Syncope; This spontaneous report as received from a pharmacist, and refers to a 66 year old female patient with asthma. The patient is allergic to sulfa, novocaine and lidocaine. Information regarding the patient's medical history was not reported. On 27-DEC-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T022294 and expiration date on 26-MAR-2022, intramuscular in the left deltoid for pneumococcal prophylaxis. On the same day, she had a syncope. The patient did not seek for medical attention and any treatment was given. At the reporting time, reported as ""this morning"", the syncope was improving but ongoing. The reporter considered syncope to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). Upon internal review, the event of syncope was considered to be medically significant. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T022294; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,UNK,PNEUMOVAX 23 SYRINGE (DEVICE),Asthma; Drug hypersensitivity,,,,['Syncope'],UNK,MERCK & CO. INC.,OT 919882,FL,,M,"Chron's disease; This spontaneous report was received from a physician referring to a 16 years old male patient. The patient's pertinent medical history, concomitant drugs and drug allergies were reported as unknown. On 29-JUN-2018, the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, anatomical location, route, lot number and expiration date were not reported) for prophylaxis. And on 31-JAN-2019, he received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On 30-JUN-2019, the patient was admitted to the hospital and on an unknown in 2019, he was diagnosed with Chron's disease. The outcome of Chron's disease was unknown. It was unknown if he received any treatment. It was unknown if the patient had sought medical attention or if any lab diagnostics/studies were performed. The outcome of crohn's disease was unknown. The causality between Chron's disease and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. Upon internal review, Chron's disease was determined to be medically significant.",Not Reported,,Not Reported,Yes,,Not Reported,U,06/29/2018,,,UNK,,,,,,"[""Crohn's disease""]",2,MERCK & CO. INC., 919883,MS,,M,"cerebrovascular accident/right leg weakness, numbness, trouble ambulating and confusion/concomitant weakness related to his cerebrovascular accident; meningoencephalitis; dementia; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 29-DEC-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered right leg weakness, numbness, trouble ambulating and confusion. The pt was diagnosed with having a cerebrovascular accident, meningoencephalitis and dementia with concomitant weakness related to his cerebrovascular accident. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of cerebrovascular accident, encephalitis, and dementia to be related to zoster vaccine live (ZOSTAVAX). The reporter considered the events of cerebrovascular accident, encephalitis, and dementia to be disabling.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/29/2017,,,UNK,,Routine health maintenance,,,,"['Cerebrovascular accident', 'Confusional state', 'Dementia', 'Encephalitis', 'Gait disturbance', 'Hypoaesthesia', 'Muscular weakness']",UNK,MERCK & CO. INC.,OT 919884,OH,,F,"congestive heart failure; renal failure; lung problems; Information has been received regarding a case in litigation from an attorney concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not provided. On unspecified date, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (lot #, expiration date, route of administration, dosage, and anatomical location were not provided) for prevention of shingles. After receiving the dose of Zoster Vaccine Live (ZOSTAVAX), the patient suffered congestive heart failure, lung problems and renal failure. As a result of these symptoms, the patient was seen and treated by the medical provider and was still under their care. As a direct and proximate result of vaccination, the patient's symptoms have resulted in physical limitations not present prior the use of this vaccine, and the patient sustained severe and permanent personal and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of the report, the reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX). The patient had not recovered from the events, and the author considered the events to be disabling. Upon internal review cardiac failure congestive and renal failure were considered medically significant.",Not Reported,,Not Reported,Not Reported,,Yes,N,,,,UNK,,,,,,"['Cardiac failure congestive', 'Lung disorder', 'Renal failure']",UNK,MERCK & CO. INC., 919893,PA,,F,"severe swelling in the arm, so bad it looked like cellulitis/ severe reaction; severe swelling in the arm, so bad it looked like cellulitis/ severe reaction; This spontaneous report was received from a female patient of unknown age who was reporting on herself. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided. On 25-SEP-2018, she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location, strength, lot number and expiration date were not provided) for prophylaxis. The patient requested ingredients contained in pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) because on an unknown date in September 2018 she experienced severe swelling in the arm. The swelling looked so bad, like cellulitis. She sought for medical attention and informed her physician about this event, but also refused to inform if ant treatment was provided. The outcome of arm swelling looking like cellulitis was unknown. The reporter did not provide a causal assessment between the mentioned events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). Upon internal review, cellulitis was determined to be medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,09/25/2018,09/01/2018,,UNK,,,,,,"['Cellulitis', 'Peripheral swelling']",UNK,MERCK & CO. INC., 919896,,,F,"Lamictal levels were 14/lamictal levels went high; It must be her Vagus Nerve stimulated because she is getting nervous; They said her levels were low; The caller was difficult ot understant at times and mumbled a lot/the caller had to be redirected multiple times in the conversation and went off track often; moving around; with Phenobarbital she will get delusions and make up delusions in her head: delusions; Getting nervous; It made her behaviorally off; It made her behaviorally off/she was repeating the same peoples names over and over; This spontaneous report was received from a 30-year-old White female patient reporting on herself. On an unspecified date, her weight was between 97 and 98 pounds. Her pertinent medical history included a memory changed to the right temporal lobe, a Chinese viral infection which caused her a fever of 104.5 (units not provided), scar tissue which was formed during the viral infection (also reported as ""unsure if she was born with it""), and epilepsy for 27 years. Concomitant medications included clobazam (ONFI). Since approximately 1994 (also reported as when she was 6-year-old), the patient started therapy with phenobarbital for epilepsy (dose, frequency, route of administration, lot number and expiration date were not reported). This was the most helpful drug to treat her epilepsy; nevertheless, its levels had gone up naturally, she was unsure of how many times she had been high on it. It was also mentioned that she had cheated on her phenobarbital treatment. On an unknown date, therapy with lamotrigine (LAMICTAL) was started (dose, frequency, route of administration, lot number and expiration date were not reported). On an unspecified date of September 2018, in order to go to school, the patient was vaccinated by a student with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported). On an unknown date of September 2018 (also reported as 2 weeks after receiving measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)) the patient's lamotrigine (LAMICTAL) increased to 14 (units not provided) (also reported as ""her lamotrigine (LAMICTAL) went high"") (anticonvulsant drug level increased) which made her behaviorally off (abnormal behavior). Consequently, the patient got to the emergency room (ER) and then she was hospitalized due to the event of anticonvulsant drug level increased. It was reported that she was repeating the same people's names over and over (repetitive speech) and she was moving around a little (restlessness). A nurse and a friend helped to calmed down her. Later, a doctor asked her if the had cheated on her phenobarbital; nevertheless, she told them that she did not this time. She explained that the difference between phenobarbital and lamotrigine (LAMICTAL) when they went up was that with phenobarbital she would get delusion and made up delusions in her head and she could remember everything; in contrast, with lamotrigine (LAMICTAL) she could not remember much (amnesia). On an unspecified day, a lab test (unspecified) was performed by some students and it was found that ""her levels were low"" (anticonvulsant drug level decreased); however, the patient was wondering if the students did the test correctly. The patient stated that on an unspecified date of September 2018, she had her vagus nerve stimulated since she was getting nervous (vagus nerve disorder, nervousness). On an unspecified date of September 2018, she recovered from anticonvulsant drug level increased after 7 days of hospitalization and she was discharged from the hospital on day 8. The patient was asking if the COVID vaccine (unspecified) would interfere with her lamotrigine (LAMICTAL) phenobarbital and clobazam (ONFI) levels. She was also asking if fever is a possible side effect of the COVID vaccine (unspecified), because if the fever would be between 101-102 (units unspecified) she would propbably present seizures and would need to be hospitalized. During the call, it was reported that the patient was difficult to understand and mumbled a lot; furthermore, many attempts of clarification had to be made and she had to be redirected multiple times in the conversation and she went off track often (speech disorder). It was not reported if the patient received any treatment for the aforementioned adverse events. The action taken with phenobarbital, and lamotrigine (LAMICTAL), the outcome of the event of speech disorder, repetitive speech, vagus nerve disorder, nervousness, restlessness, amnesia, and anticonvulsant drug level decreased and the causal relationship between the event and therapy with the suspect theapies were not reported. Upon internal review, the event agus nerve disorder was considered to be medically significant (OME).",Not Reported,,Not Reported,Yes,7.0,Not Reported,Y,09/01/2018,09/01/2018,0.0,OTH,LAMICTAL; Phenobarbital,Epilepsy; Memory impairment,Medical History/Concurrent Conditions: Anticonvulsant drug level increased (She was unsure how many times she has been high on it. She got delusions and made up delusions in her head and she could remember everything.); Intentional product misuse; Scar; Viral infection (It gave her a fever of 104.5 (units not provided) and scar tissue was formed during it.Or she was born with it.),,,"['Abnormal behaviour', 'Anticonvulsant drug level decreased', 'Anticonvulsant drug level increased', 'Nervousness', 'Repetitive speech', 'Restlessness', 'Speech disorder', 'Vagus nerve disorder']",UNK,MERCK & CO. INC., 919900,,67.0,F,"she passed out; she couldn't see; sick; stomach started to hurt; had chills; her arms hurt; she was freezing; her arm had swollen like a balloon; her arm had swollen like a balloon and became hard as a rock; hit her head; dizzy; she couldn't walk around her house; Her heart was ""loudly"" palpating; extremely low blood pressure/Her heart was ""loudly"" palpating; This spontaneous report as received from a consumer concerning herself a 67 year old patient. Pertinent medical history, drug reactions and allergies, and concomitant medications were reported as none. Early in June 2017, the patient was vaccinated with a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in the left arm for prophylaxis (route of administration, lot number and expiration date were not reported). In June 2017, reported as later that same date after received the vaccine, she started to feel sick. She reported that her stomach started to hurt, had chills, and her arms hurt. As the day progressed, her sickness continually ""got worse and worse"". She reported that she was freezing despite tons of clothing and layers on. The next day her arm had swollen like a balloon and became hard as a rock. At one point she passed out and hit her head on her dresser. When she woke up, she couldn't see, and eventually her sight came back in blobs/spots (blindness transient). Over the next week, approximately in June 2017, it progressively became worse and she reported being so dizzy that she couldn't walk (blindness transient) around her house without grabbing onto a wall (Gait inability). Her heart was ""loudly"" palpating (Heart rate decreased) and she had an extremely low blood pressure. One doctor told her that her ""heart is just not operating as it should"", however a different doctor said her heart was fine. After completing a detox, changing her diet, and taking vitamin supplements she slowly started feeling better (also reported as not recovered by the same reporter). She reported that she ""hasn't been the same"" since she received that re-vaccination. She still currently experienced dizziness from time to time and was afraid to take the COVlD-19 vaccine due to her adverse experience with the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine. None laboratory test was performed The outcome of illness, hypotension, heart rate decreased, gait inability, dizziness, head injury, induration, peripheral swelling, feeling cold, pain in extremity, chills and abdominal pain upper was reported as not recovered. The outcome of loss of consciousness and blindness transient was reported as recovered, on an unspecified date in 2017 (conflicting information also reported as not recovered). The causal relationship between the events and therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was assessed as related by reporter. Upon internal review the events of passed out and she couldn't see (Blindness transient )was considered to be medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,06/01/2017,06/01/2017,0.0,UNK,,,,,,"['Abdominal pain upper', 'Blindness transient', 'Chills', 'Dizziness', 'Feeling cold', 'Gait disturbance', 'Head injury', 'Heart rate decreased', 'Hypotension', 'Induration', 'Loss of consciousness', 'Malaise', 'Pain in extremity', 'Palpitations', 'Peripheral swelling']",2,MERCK & CO. INC., 919902,CA,67.0,M,"shingles; death; Information has been received from a lawyer refers to an erderly male patient. The patient's medical history and concurrent conditions were not reported. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, unit, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions, in medical office. Subsequently, the patient was treated by various healthcare providers at medical offices for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of shingles was not reported. On 28-JUL-2018, the patient died (the cause of death and autopsy information were not reported). The reporter considered death and shingles to be related to zoster vaccine live (ZOSTAVAX).",Yes,07/28/2018,Not Reported,Not Reported,,Not Reported,N,,07/28/2018,,UNK,,,,,,"['Death', 'Herpes zoster']",UNK,MERCK & CO. INC.,OT 919903,TX,,U,"I have Horner's Syndrome / onset coincides with receiving dose 1 of Shingrix; my right eye is effected with partial closings; experiencing headaches, pretty much constantly; This case was reported by a consumer and described the occurrence of horner's syndrome in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On 1st November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced horner's syndrome (serious criteria GSK medically significant), lagophthalmos and headache. On an unknown date, the outcome of the horner's syndrome and lagophthalmos were unknown and the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the horner's syndrome, lagophthalmos and headache to be related to Shingrix. Additional details were provided as follows: The age group was not reported but was selected adult as per vaccine indication. The age at vaccination was not reported. The patient received 1st dose of Shingrix and pretty much in the days after, the problems started. The patient stated that he/she had located very minimal information on a link with Shingrix and Horner's Syndrome and he/she had Horner's and the onset coincides with receiving dose 1 of Shingrix. The patient had a brain scan, lung scan and carotid artery scan to rule out tumors as a cause of the Horner's Syndrome and the scans had all been good, but his/her right eye was affected with partial closing and he/she was experiencing headaches, pretty much constantly. The patient wanted to know if we had any reported information on a link with Shingrix and, if so, was that information we would share with patient. The patient was concerned about the financial aspect of all the testing, concerned about the constant headaches and also about the eye and certainly, concerned about the 2nd dose. The patient mentioned that he/she did like information to get an idea of how long this might last and if it would resolve and wanted to let him/her know if we had any information.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,11/01/2020,,,UNK,,,,,,"['Brain scan normal', 'Headache', ""Horner's syndrome"", 'Lagophthalmos', 'Ultrasound Doppler', 'Ventilation/perfusion scan normal']",1,GLAXOSMITHKLINE BIOLOGICALS, 919904,TX,,F,"tested positive for COVID19 via antigen test; tested positive for COVID19 via antigen test; having no sense of taste and smell; having no sense of taste and smell; fever; scratchy throat; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ168J), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After getting vaccinated, patient developed a fever on 22Dec2020. On 23Dec2020, the patient has no taste and smell and tested (used the Sofia test) positive for COVID. The patient was told to quarantine and take off work for 10 days. The patient has felt like she has had a scratchy throat. Patient has not taken her allegra. The outcome of events was unknown.; Sender's Comments: A causal role of BNT162B2 would seem unlikely based on the temporal gap between the vaccination and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/01/2020,,UNK,,,,,,"['Ageusia', 'Anosmia', 'Pyrexia', 'SARS-CoV-2 test positive', 'Throat irritation']",UNK,PFIZER\BIONTECH, 919905,,,F,"patient received the PFIZER-BIONTECH COVID-19 MRNA VACCINE and then tested positive for COVID; patient received the PFIZER-BIONTECH COVID-19 MRNA VACCINE and then tested positive for COVID; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number and Expiration Date: Unknown), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included high body mass index (BMI) from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 22Dec2020, the patient received the PFIZER-BIONTECH COVID-19 MRNA VACCINE and then tested positive for COVID; and showed symptoms. The events were assessed as medically significant. The clinical course was reported as follows: The 40-year-old female patient, with comorbidities ""like high BMI"", received the Pfizer BioNTech COVID vaccine on 18Dec2020 and she had tested positive for COVID on 22Dec2020 and she was showing symptoms; however, they were not severe. The pharmacist did not describe the symptoms. In response to further probing, the pharmacist stated, ""can I do this tomorrow because I need to call patient and ask her about if they have an opinion regarding the monoclonal antibodies treatment."" The pharmacist wanted to know if there was information on consumers receiving antibodies after receiving the vaccine. The pharmacist stated the patient was eligible for antibody treatment. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 22Dec2020. The clinical outcome of the events was unknown. The batch/lot numbers for the vaccine, BNT162B2, were not provided and will be requested during follow up.; Sender's Comments: The reported tested positive for COVID after immunization with BNT162B2 is considered related to the administration of the suspect, BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/22/2020,4.0,UNK,,,Medical History/Concurrent Conditions: Body mass index high,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 919906,MO,,F,"tested positive for covid; tested positive for covid; coughing; congestion; could not sleep that night; her temperature is still low/temperature was lower around 96 or 97; fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EH9899), via an unspecified route of administration on 15Dec2020 at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Covid-19 shot 8 days ago on 15Dec2020. She tested positive for COVID on 23Dec2020. She worked in the emergency room, clarified she was a certified Nurse Assistant (CNA). She was hesitant about taking the COVID-19 vaccine. She was curious since she has been around the virus 24/7 since the pandemic started since she works in the emergency room. When she took the COVID-19 shot, stated she felt great the next day and could not sleep at night in Dec2020 which is not normal for her. It's nothing like the flu shot. It was strange since she has been around the virus all this time, she felt like she had COVID in Feb2020, but she was not tested then. She does not ever get sick and she was down for two days with a fever in Dec2020. After those two days, she always had a low-grade fever of 98 or 99 which was constant. After she took the COVID vaccine her temperature was normal, her temperature was lower around 96 or 97 in Dec2020. She woke up on 23Dec2020 and she had congestion and her temperature was still low. She went to work, and she was told she looked like she had no sleep. She was coughing 23Dec2020 morning, but she did not have any symptoms as far as temperature. She realized that the COVID 19 shot is only 50% effective. She is asking if she should get the second dose. The outcome of events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/15/2020,12/01/2020,,UNK,,,,,,"['Cough', 'Pyrexia', 'Respiratory tract congestion', 'SARS-CoV-2 test positive', 'Sleep disorder']",1,PFIZER\BIONTECH, 919907,,,U,"30 mins after vaccination caller was notified patient tested positive for covid; 30 mins after vaccination caller was notified patient tested positive for covid; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. 30 mins after vaccination caller was notified patient tested positive for covid on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available (30 mins after vaccination Covid test found positive), no effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 Nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 919908,TN,46.0,F,"tested positive COVID; tested positive COVID; nasal congestion; loss of smell; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730, Expiration Date Mar2021), via an unspecified route of administration in her right deltoid on 19Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing Crohn's disease from 2007/ diagnosed at 33 years old. There were no other concomitant drugs. The doctor who received the COVID vaccine stated that she must had been exposed to the virus prior to receiving the vaccine because she became symptomatic 48 hours after getting the vaccine. She noted that on Pfizer website recommended that a person not get the vaccine until 6 weeks after active infection but she of course did not know she had been exposed and when her second dose was due, she would not be 6 weeks after active infections. The vaccine was received on 19Dec2020 and she tested positive on 22Dec2020. The only symptoms she had experienced after testing positive are nasal congestion and loss of smell and they started on 21Dec2020 in the morning. She had had no worsening of her Crohn's disease. The only testing she had had done was the PCR testing for COVID. No treatments for the symptoms at this point. The outcome of the events tested positive COVID was not recovered, while for other events was unknown.; Sender's Comments: A causal role of BNT162B2 would seem unlikely based on the temporal gap between the vaccination therapy and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/21/2020,2.0,UNK,,Crohn's disease (Verbatim: Crohn's disease/ diagnosed at 33 years old),,,,"['Anosmia', 'COVID-19', 'Nasal congestion', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 919909,CA,33.0,M,"Tested positive for covid; Tested positive for covid; This is a spontaneous report from a contactable nurse (patient). A 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscularly at right arm on 18Dec2020 14:30 at single dose for COVID-19 immunization. Medical history included asthma. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed severe nasal burning sensation the first two days of injection along with severe headache that lasted for 4 days. He lost his sense of taste and smell (23Dec2020) 5 days after vaccine was administered, tested positive for Covid (23Dec2020 16:30) with use of ABBOTT rapid test which was performed at his employment. Pending Covid nasal swab fulgent which was obtained on 23Dec2020 and sent out to reference lab. Patient was just wondering if any of these symptoms and/or testing positive after administration was a rare side effect. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was not recovered.; Sender's Comments: Vaccine BNT162B2 provides protection to COVID-19 after at least 7 days have elapsed from the second dose (21 days post first injection). These conditions are not met in the present report. The reported symptoms are compatible with COVID-19 illness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/23/2020,5.0,PVT,,,Medical History/Concurrent Conditions: Asthma,,,"['Ageusia', 'Anosmia', 'COVID-19', 'Headache', 'Nasal discomfort', 'SARS-CoV-2 test positive', 'Viral test']",1,PFIZER\BIONTECH,OT 919910,MN,68.0,F,"positive for Covid with symptoms; positive for Covid with symptoms; positive for streph; positive for influenza; This is a spontaneous report from a contactable physician and nurse. A 68-year-old female patient received bnt162b2, via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced positive for COVID with symptoms, positive for streph and positive for influenza in Dec2020. Additional Context: caller stated that she had a patient that got Covid vaccine on 17Dec2020 who was complaining of muscle aches, no fever, sudden loss of taste and smell in the last 24 hours, sore throat and a cough. Stated that she cannot attribute the cough to the vaccine. Stated that she was screened for COVID, streph and influenza. Stated that she was positive for covid and streph. Stated that she does not think that and wanted to know if the vaccine would cause a positive from a rapid test. Outcome of the events was unknown. The Lot/Batch and expiry date has been requested.; Sender's Comments: The reported positive for COVID with symptoms after immunization with BNT162B2 is considered related to the suspect, BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/01/2020,,OTH,,,,,,"['Ageusia', 'Anosmia', 'COVID-19', 'Cough', 'Influenza virus test positive', 'Myalgia', 'Oropharyngeal pain', 'SARS-CoV-2 test positive', 'Streptococcus test positive']",UNK,PFIZER\BIONTECH, 919911,GA,50.0,F,"allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her legs/ rash all over her; Fever/ feverish; a fast heart rate that comes and goes; Hasn't felt good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 21Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. She indicated she received vaccine on 21Dec2020 and noticed a rash on her legs in the shower on 24Dec2020. She hadn't felt good since done on 21Dec2020. She had a rash all over her, didn't realize when went back and read a paper, said a bad rash all over body, what should she do, take a Benadryl. She stated the health department gave the vaccine. She had been a little sick since she had it. Tuesday was really bad, all day on Tuesday, she really felt bad. She woke up with a rash at the time of the report on 24Dec2020, she thought she had a fever, but didn't check, that was last night and this morning, but at the time of the report she didn't think she had a fever. The rash, she was covered in a fine rash all over her body, she had thought it had happened with an allergic reaction immediately. When asked for outcome of not feeling good, stated she felt ok, it was just the rash, that was what she was most concerned about, stated she did have a fast heart rate that comes and goes on 21Dec2020. When she awoke this morning, she was just weak, and feverish, she didn't take her temperature, she should have, but she took a shower a few minutes and saw the rash, thought it was probably all combined. Stated her card said on 11Jan2021, she should take the second dose, and wanted to known should she take it if this is all connected. The patient had tested positive for COVID antibodies on an unspecified date. The outcome of the events ""rash on her legs/ rash all over her"" and ""Fast heart rate"" was not recovered, while other events were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Asthenia', 'Feeling abnormal', 'Heart rate increased', 'Hypersensitivity', 'Illness', 'Malaise', 'Pyrexia', 'Rash', 'SARS-CoV-2 antibody test']",1,PFIZER\BIONTECH, 919912,IL,26.0,F,"Lip swelling and redness; Lip swelling and redness; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (nor pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (right arm) on 21Dec2020 (10:45) at single dose for COVID-19 immunization. The patient's medical history included asthma. Concomitant medication included montelukast sodium (SINGULAIR) cetirizine hydrochloride (ZYRTEC) and acetazolamide sodium (DIAMOX), received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced lip swelling and redness on 24Dec2020 (04:00 AM). The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was advised to continue Singulair and given Benadryl and ointment as treatment for the adverse events. The outcome of events was unknown. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/24/2020,3.0,PVT,SINGULAIR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; DIAMOX [ACETAZOLAMIDE SODIUM],,Medical History/Concurrent Conditions: Asthma,,,"['Lip erythema', 'Lip swelling']",UNK,PFIZER\BIONTECH, 919913,NM,,F,"Chills, fever and a headache; Chills, fever and a headache; Chills, fever and a headache; tested positive; tested positive; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is 1st of two reports. An adult female patient of unspecified age (30-40 yrs of age) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The nurse stated that they gave the vaccines to the patient the past week and the patient was COVID-19 positive at the time of the report. The nurse needed some guidance and needed to know if the patient could receive the second dose or what they were supposed to do. The patient tested positive for COVID-19 on 24Dec2020 after having chills, fever and a headache. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded. The case will be reassessed should additional information become available.,Linked Report(s) : US-PFIZER INC-2020513401 different patient, same drug and event",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/24/2020,7.0,UNK,,,,,,"['Chills', 'Headache', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 919914,,,M,"Fever; Fatigue; Shortness of breath; Chest pain; Dizziness; Arm soreness; This is a spontaneous report from a non-contactable healthcare professional. This 24-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unspecified date (at the age of 24 years-old, as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were also no other medications taken in the last two weeks. On 24Dec2020, the patient experienced fever, fatigue, chest pain, shortness of breath, arm soreness, and dizziness. The patient was not hospitalized for the events but received treatment with acetaminophen (TYLENOL). The clinical outcome of the events of fever, fatigue, chest pain, shortness of breath, arm soreness, dizziness was not recovered. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/24/2020,,UNK,,,,,,"['Chest pain', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH, 919915,IN,32.0,F,"chills; body aches; tender left deltoid injection site pain.; fatigue; elevated temp/ tympanic temp of 100.8; This is a spontaneous report from a contactable nurse reporting for herself. A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number EJ1685, via an unspecified route of administration on 21Dec2020 12:30 as a single dose (dose 1) in the left arm (age at vaccination: 32 years old) for COVID-19 vaccination. The facility where the most recent COVID-19 vaccine was administered wasa hospital. There were no other vaccines given in the 4 weeks prior to the COVID-19 vaccine. The patient was not pregnant at the time of vaccination. Medical history included diagnosed with COVID-19 on 06Jul2020, irritable bowel syndrome (IBS), depression, attention deficit hyperactivity disorder (ADD), cervical spondylosis, and herpes simplex virus (HSV); no allergies to medications, food, or other products. Concomitant medication included methylphenidate hydrochloride (CONCERTA), sertraline hydrochloride (ZOLOFT), valacyclovir, levonorgestrel (LILETTA), and colecalciferol (VITAMIN D). The patient woke up at 0400 on 22Dec2020 with tympanic temp of 100.8, chills, body aches, and very tender left deltoid injection site pain. The events were reported as non-serious. Treatment with ibuprofen resolved the elevated temperature, however she spent all of 22Dec2020 with fatigue and body aches despite ibuprofen. The tender left deltoid persisted for a total of 3 days and then became more tolerable, less tender. The clinical outcome of elevated temp/ tympanic temp of 100.8 was resolved on 22Dec2020, of fatigue and body aches was recovered on 23Dec2020, and of chills and tender left deltoid was recovered on an unknown date. Since the vaccination, has the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,CONCERTA; ZOLOFT; VALACYCLOVIR [VALACICLOVIR]; LILETTA; VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: ADD; Cervical spondylosis; COVID-19; Depression; HSV infection; Irritable bowel syndrome,,,"['Body temperature', 'Chills', 'Fatigue', 'Pain', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 919916,PA,53.0,F,"The next day a rash appeared on my forearms and now is on my ankles, calves and scalp.; Severe headache; chills; flu like symptoms; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly at left arm on 18Dec2020 at 14:00 at single dose for covid-19 immunization at workplace clinic. Medical history included hypolipidaemia, allergic to sulfa drugs (hives), allergy to adhesive (severe skin blistering). There was non other vaccine in four weeks and no other medications in two weeks. The patient previously took naproxen (NAPROSYN) and amoxicillin clavulanic acid (AUGMENTIN ) and was allergic to both drugs, and experienced anaphylaxis for naproxen. The patient experienced severe headache, chills and flu like symptoms the night after the shot on 18Dec2020. The next day on 19Dec2020 at 10: 00 AM a rash appeared on her forearms and was on her ankles, calves and scalp at time of the report. No treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,WRK,,,Medical History/Concurrent Conditions: Blister; Dermatitis contact (severe skin blistering); Hypolipidemia; Sulfonamide allergy (I am allergic to sulfa drugs (hives)),,,"['Chills', 'Headache', 'Influenza like illness', 'Rash']",1,PFIZER\BIONTECH,OT 919917,NY,43.0,F,"had another COVID test with positive results on 23Dec; had another COVID test with positive results on 23Dec; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 18Dec2020 at a single dose for covid-19 vaccination. The vaccination was done in the hospital. The patient's medical history and concomitant medications were not reported. The patient was initially tested negative for covid-19 on 13Dec2020. The patient was not pregnant. The patient believed she may have been infected with COVID as early as 13Dec2020 based on symptoms but test results at that time came back negative. She had vaccine on 18Dec2020 and when symptoms hadn't resolved had another COVID test with positive results on 23Dec2020. The event resulted to a doctor or other healthcare professional office/clinic visit. There was not treatment for the event. The reporter considered the events as non-serious. The outcome of the event was recovering. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/23/2020,5.0,PVT,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 919918,NY,67.0,F,"flushing; lightheadedness; chills; tongue numbness; dry mouth; cold hands and feet; This is a spontaneous report from a contactable physician (patient herself). A 67-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration on 24Dec2020 13:15 in left arm at single dose for covid-19 immunization. Medical history included none. The patient was not allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included methylphenidate hydrochloride (RITALIN) and one-a-day ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS), both from Dec2020 for an unspecified indication. Immediately after vaccine, patient experienced flushing, then lightheadedness, and waves of flushing and chills every minute for several hours; tongue numbness, dry mouth, cold hands and feet; no rash, no breathing difficulty - normal vital signs on 24Dec2020 13:30. Patient received iv diphenhydramine hydrochloride (BENADRYL) and famotidine (PEPCID) and iv hydration after symptoms were not improving 3 hours later - several hours after this treatment, the flushing and chills continued, as did numbness of tongue and dry mouth. Symptoms were still present 22 hours after injection-waves of flushing and chills. The events were reported as non-serious and the events resulted in Emergency room/department or urgent care. Outcome of events were not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,UNK,RITALIN; VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Dizziness', 'Dry mouth', 'Flushing', 'Hypoaesthesia oral', 'Peripheral coldness', 'Vital signs measurement']",1,PFIZER\BIONTECH, 919919,,31.0,F,"Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; This is a spontaneous report from a non-contactable Other healthcare professional (HCP) (patient). A 31-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E4284), via an unspecified route of administration on 22Dec2020 11:30 at a single dose in left arm for COVID-19 immunization. Medical history included asthma, known allergies: dust mites. The patient experienced soreness on day 2 (24Dec2020) and day 3 (25Dec2020), site of injection was swollen, painful, and itched on 24Dec2020. No other vaccine in four weeks received. No treatment received for these events. The patient had no COVID prior vaccination or no COVID tested post vaccination. This is a non-serious report. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/24/2020,2.0,WRK,,,Medical History/Concurrent Conditions: Asthma; Dust allergy; Mite allergy,,,"['Pain', 'Vaccination site pain', 'Vaccination site pruritus', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 919920,CA,39.0,F,"Headache; fatigue; general malaise; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number EJ1685, via an unspecified route of administration on Left arm from 22Dec2020 09:00 to 22Dec2020 09:00 as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included ademetionine (SAME). On 24Dec2020 09:00, the patient experienced headache, fatigue, general malaise at about 48 hours after receiving vaccine. Lasted about 1 day. The outcome of the events was recovered on 25Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,PUB,SAME [ADEMETIONINE],,,,,"['Fatigue', 'Headache', 'Malaise']",1,PFIZER\BIONTECH, 919921,,46.0,M,"Shoulder soreness, malaise; Shoulder soreness, malaise; This is a spontaneous report from a non-contactable physician reported for himself. A 46-year-old male patient received bnt162b2, lot: EH9899, via an unspecified route of administration at 11:00am on 24Dec2020 at a single dose for covid-19 immunization. The patient's medical history included gout from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 24Dec2020, the patient experienced shoulder soreness and malaise. The outcome of the event was recovered on an unknown date. It was reported that the vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was given to the patient for the events. Patient was not diagnosed with COVID-19 prior to vaccination and patient have not been tested for COVID-19. Patient has no allergies to medications, food and other products. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Gout,,,"['Arthralgia', 'Malaise']",1,PFIZER\BIONTECH, 919922,FL,53.0,F,"urticaria on the chest and leg; This is a spontaneous report from a contactable physician (patient). A 53-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 16Dec2020 21:00 at a single dose for COVID-19 immunization at the workplace clinic. Medical history included sulfa allergies. Concomitant medication included ibuprofen. The patient had not received other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced urticaria on the chest and leg on 24Dec2020 20:00. Outcome of the event was not recovered; no treatment was given for the event. The patient was not diagnosed with COVID prior vaccination and has not been tested for COVID post vaccination. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/24/2020,8.0,WRK,,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,['Urticaria'],1,PFIZER\BIONTECH, 919923,CA,31.0,F,"whole left arm was numb/numbness and itching happened also to the soles of feet; itching happened also to the soles of feet/hands also became red and itchy; hands also became red; hives; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient (non-pregnant) receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 20Dec2020 11:45 at single dose at left arm for immunization. Medical history included known allergies: sulfa. Concomitant medication in two weeks included bupropion hydrochloride (WELLBUTRIN). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Immediately following vaccination, patient whole left arm was numb, the numbness slightly improved, but then only palms of hands were numb. Later that night, the numbness and itching happened also to the soles of feet, hands also became red and itchy, and then patient got hives that lasted 48 hours, but nightly hives after that, the hives would resolve after taking PO (per oral) diphenhydramine hydrochloride (BENADRYL), and then would come back again that night. Patient was still having them. The adverse events resulted in emergency room/department or urgent care. Outcome of events was reported as recovered/resolved with sequel. The report is considered as non-serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/20/2020,0.0,PVT,WELLBUTRIN,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,"['Erythema', 'Hypoaesthesia', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,OT 919924,MN,30.0,M,"Migraine 1 day after injection; Headache; arthralgias; myalgia; chills; low grade fever; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 30-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose at left arm for immunization. Medical history was none. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient experienced migraine 1 day after injection, headache, arthralgias, myalgia, chills, low grade fever on days 1-6 post injection which are improving. Patient received Ibuprofen 400 mg daily for events. The report is considered non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/01/2020,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Chills', 'Headache', 'Migraine', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH, 919925,,33.0,M,"neck stiffness; left thumb joint pain; right arm pain around injection site; This is a spontaneous report from a contactable unspecified health professional. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, expiry date: unknown, intramuscular at the right arm, from 22Dec2020 12:15 at a single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included simvastatin. On 22Dec2020 18:00 (Tuesday night), the patient experienced left thumb joint pain and right arm pain around injection site. On Wednesday, above issues continued. On 24Dec2020 18:00, Thursday, patient had neck stiffness. The joint pain all over was not severe but noticeable. Outcome of events was reported as unknown. There was no treatment or hospitalization involved. This case is non-serious. No follow-up attempts are possible. No further information is expected. The information on the batch/lot number was obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,PVT,,,,,,"['Arthralgia', 'Musculoskeletal stiffness', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 919926,,,F,"anxiety; hives; itching; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (age: 45; unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced symptoms of hives, itching and anxiety on Dec2020. Outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Anxiety', 'Pruritus', 'Urticaria']",UNK,PFIZER\BIONTECH, 919927,CA,42.0,M,"Muscle ache; Chills; Headache is so severe most disturbing one; it was getting too bad, my head want to fall off, I could not work; Left arm is too sore way it was administered; This is a spontaneous report from a contactable consumer who reported for himself. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Dec2020 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was reported as none. Concomitant medications were reported as none. On an unspecified date (""roughly"" 6 hours after the vaccine was administered) the patient experienced ""muscle ache"", ""chills"", ""headache is so severe most disturbing one; it was getting too bad, my head want to fall off, I could not work"" and ""left arm is too sore way it was administered"". The patient reported that he called ""because he took the COVID-19 vaccine last night and he had been having reactions from last time till this time"" (as reported). The patient stated that there was no doctor that prescribed the medication, it was administered to him because he was a healthcare worker (certified nursing assistant). He stated that he had been having ""muscle ache, chills and severe headache, the headache is so severe, the most disturbing one."" He reported that one of the Tylenol doses was administered to him by the nurse that administered the vaccine. He reported that he took some Tylenol and ibuprofen but this time it was not helping. He stated that he received the vaccine about 24 hours ago and started to experience muscle ache, chills and severe headache roughly about 6 hours after the administration. He reported that ""I could hang in, but it was getting too bad, my head wanted to fall off, so I am driving home now so I could not work."" When the patient was asked about the vaccine dose and route he stated ""I believe normal dose I believe, I cannot remember I cannot recap anything, but I know it was administered in my left arm, my left arm is too sore the way it was administered."" He stated that he received the vaccination for prevention and to be on the safe side. The patient stated that he did lab work with his doctor a few months ago, probably around 6 or 7 months ago. The clinical outcome of the events ""muscle ache"", ""chills"", ""headache is so severe most disturbing one; it was getting too bad, my head want to fall off, I could not work"" were all not recovered/not resolved, while the clinical outcome of the event ""left arm is too sore way it was administered"" was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Headache', 'Myalgia', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 919928,TX,46.0,F,"Dizziness; Shortness of breath; Tightness in throat; Blurred vision; Tingling in hands and face; This is a spontaneous report from a contactable consumer who reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 22Dec2020 at 06:40 (at the age of 46-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history and family medical history were both reported as none. Concomitant medications were reported as none. It was reported that history of all previous immunizations was unknown and that the patient had no previous adverse events following prior vaccinations. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any additional vaccines on the same date as BNT162B2. On 22Dec2020 the patient experienced ""dizziness"", ""shortness of breath"", ""tightness in throat"", ""blurred vision"" and ""tingling in hands and face"". The adverse events required a visit to the Emergency Room; however, the patient was not admitted to the hospital and was discharged from the Emergency Room. The patient stated that she had a reaction to the COVID-19 vaccine. She reported that she was in the Emergency Room and was still feeling dizzy after being released. The clinical course was reported as follows: ""Started off with dizziness, shortness of breath, and then tightness in her throat. Also had blurred vision, and tingling in hands and face. Occurred 25 to 30 minutes after receiving the COVID-19 vaccine. Continuing to experience dizziness that comes in waves after being released from emergency room."" The patient stated that she received the vaccine to protect herself and her family. She called to inquire what she could expect, and what her next steps were in terms of the dizziness. She was advised to follow-up with her healthcare provider. It was reported that there were no relevant tests. The clinical outcome of the event ""dizziness"" was not recovered/not resolved, while the clinical outcomes of the events ""shortness of breath"", ""tightness in throat"", ""blurred vision"" and ""tingling in hands and face"" were all unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dizziness', 'Dyspnoea', 'Paraesthesia', 'Throat tightness', 'Vision blurred']",UNK,PFIZER\BIONTECH, 919929,CA,36.0,F,"woke up with a slight headache; she felt her whole arm was sore; slight soreness at the injection site; felt some warmness right after the vaccine, like she felt kind of high; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular at deltoid left on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history included ongoing high blood pressure. Concomitant medication included hydrochlorothiazide/losartan (strength: 25mg/320mg, formulation: tablet), oral one dose form from an unknown date and ongoing, once a day for blood pressure high. The patient previously took flu vaccine for immunization and experienced soreness in her arm and generally felt tired throughout that week. The patient reported that on 23Dec2020 she felt some warmness right after the vaccine, like she felt kind of high (she doesn't know if it was just nerves with this being a new vaccine) and slight soreness at the injection site, on 23Dec2020 at 19:00 she felt her whole arm was sore and on 24Dec2020 she woke up with headache. The patient outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,UNK,HYDROCHLOROTHIAZIDE + LOSARTAN,Blood pressure high (Verbatim: High blood pressure),,,,"['Feeling hot', 'Headache', 'Pain in extremity', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 919930,CA,39.0,F,"in the arm where she received the shot, her hand and wrist go numb with pins and needles; in the arm where she received the shot, her hand and wrist go numb with pins and needles; her arm is sore; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration (left arm) on 20Dec2020 06:00 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other vaccine administered on same date of the Pfizer vaccine. The patient reported that she had the vaccine on Sunday (20Dec2020) and had a side effect that she didn't see listed. She stated that in the arm where she received the shot, her hand and wrist go numb with pins and needles, it was getting progressively less. She added that her arm is sore, but she expected that. She further stated that last night it just happened one time and it feels a lot better now. The patient asked if those were an expected side effect. The patent clarified that she received the COVID 19 vaccine on 20Dec2020 0600 in the left arm. On 21Dec2020 in the night at 0200 she woke up with pins and needles in her hand and wrist. It happened only when she was asleep and not moving her arm. She added that actually she feels it very faint off and on in the day but each night it has improved. She further clarified that the pins and needles are in her lower arm and wrist radiating up the arm. She added that she will be scheduled for the second dose. The outcome of event vaccination site pain was unknown, while the outcome of other events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/01/2020,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Hypoaesthesia', 'Paraesthesia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 919931,MN,,U,"2 hours later, had a slight headache; Right arm that I took the vaccine is really hurting; Feeling like heavy; I am just really sore, my whole body; This is a spontaneous report from a contactable consumer reporting for self. A patient of unspecified age and gender received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration in the right arm on 23Dec2020 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced 2 hours after receiving the vaccine a slight headache and took Tylenol (taken as treatment) the patient just felt like heavy. The right arm where the vaccine was given was really hurting. the patient was just really sore, the whole body. The outcome of the events was unknown. Information on the lot/batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,UNK,,,,,,"['Discomfort', 'Headache', 'Pain', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 919932,TX,54.0,F,"she could not stop shaking; Resting heart rate went to 130; Chills; Headache; Running Temperature/She just took it now and it is 100.4 degrees Fahrenheit; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer reporting for herself. A 54-y ears-old female patient received bnt162b2 (BNT162B2) vaccine, intramuscular in the right arm on 23Dec2020 07:00 at single dose for covid-19 immunisation . Medical history included covid-19 from Jul2020 to an unknown date. There were no concomitant medications. The patient experienced chills on 24Dec2020 with outcome of recovering , nausea on 23Dec2020 23:00 with outcome of recovering , headache on 24Dec2020 with outcome of recovering , running temperature at 100.4 degrees Fahrenheit on 24Dec2020 with outcome of not recovered , feeling unwell on 23Dec2020 with outcome of not recovered , resting heart rate went to 130 on 24Dec2020 with outcome of recovering , she could not stop shaking on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 99.8 Fahrenheit; 99.2 Fahrenheit, 100.4 Fahrenheit, heart rate: 130 (66-72. Normally) , sars-cov-2 test: negative on 21Dec2020 , sars-cov-2 test: negative on 24Dec2020 . Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,,,Medical History/Concurrent Conditions: COVID-19,,,"['Body temperature', 'Chills', 'Headache', 'Heart rate', 'Heart rate increased', 'Malaise', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test', 'Tremor']",1,PFIZER\BIONTECH,OT 919933,NM,,F,"Received the vaccine and tested positive for Covid today; Received the vaccine and tested positive for Covid today; This is a spontaneous report from a contactable nurse. This nurse is reporting similar events for two patients. This is the first of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 17Dec2020 at single dose for Covid Vaccine/ COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received the vaccine and tested positive for COVID today (24Dec2020). She was having symptoms on Saturday (unspecified date in Dec2020), she received her vaccine on Thursday 17Dec2020. The reporter asked several questions, if do they get the second vaccination in 3 weeks and what will be the process, does it do anything to it, or if does it make it worse or better. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded.,Linked Report(s) : US-PFIZER INC-2020513377 same reporter, same drug, similar event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/24/2020,7.0,PVT,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 919934,NM,,F,"Received the vaccine and tested positive for Covid today; Received the vaccine and tested positive for Covid today; This is a spontaneous report from a contactable nurse. This Nurse reported similar events for two different patients. This is second of two reports. A female patient of an unspecified age received bnt162b2, via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine and tested positive for covid today (24Dec2020).It was further reported that the patient showed up positive today (24Dec2020) and her symptoms have been on and off, she just got her vaccine 21Dec2020. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Preventive effect of BNT162b2 is documented after 7 days from the second dosing. This case does not match this requirement.,Linked Report(s) : US-PFIZER INC-2020513367 same reporter/drug. different patient and event.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/24/2020,3.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 919935,CT,67.0,F,"54 hours after injection SEVERE joint pains (including to touch) lasting overnight; This is a spontaneous report from a contactable nurse (patient). A 67-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in the right arm in Dec2020 04:30 PM at a single dose for COVID-19 immunization at the hospital. Medical history included gastric distress from cow milk products, and allergies to statins, dust/ dust mites. Concomitant medications included loratadine, boswellia serrata (BOSWELLIA), famotidine (PEPCID), and vitamin C. The patient did not received other vaccine within four weeks of COVID vaccine. The patient previously took ciprofloxacin (CIPRO) and experienced allergies. The patient has not been diagnosed of COVID prior vaccination and has not been tested for COVID post vaccination. It was reported that on 23Dec2020 20:00, 54 hours after injection, the patient had severe joint pains (including to touch) lasting overnight. The event was partially improved with Tylenol, loratadine, Benadryl, boswellia; and subsided next day. Outcome of the event was reported as recovering. The event was assessed as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/23/2020,22.0,PVT,; BOSWELLIA; PEPCID [FAMOTIDINE]; VITAMIN C [ASCORBIC ACID],,Medical History/Concurrent Conditions: Distress gastrointestinal; Drug allergy; Dust allergy; House dust mite allergy,,,['Arthralgia'],1,PFIZER\BIONTECH,OT 919936,FL,30.0,F,"I experienced nasal congestion the next morning, and redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; This is a spontaneous report from a contactable physician. A 30-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration in right arm on 23Dec2020 13:30 at a single dose for covid-19 vaccination. Vaccination was done in the hospital. There were no relevant medical history and no concomitant medications. The patient was not pregnant. The patient experienced nasal congestion the next morning, on 24Dec2020 07:00, and redness, induration and pain on the injection site. The induration and redness was around 1-1.5 inches diameter. The outcome of the events was recovering. There were no treatment involved for the events. This was assessed as non-serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Nasal congestion', 'Vaccination site erythema', 'Vaccination site induration', 'Vaccination site pain']",1,PFIZER\BIONTECH, 919937,MA,66.0,F,"Have been up all night long freezing, shaking; had to take a hot bath just to warm up; Every time I get up, I get light headed; I had COVID back in March and I feel the same way I felt then except the breathing is normal; Very weak; This is a spontaneous report from a contactable consumer reporting for herself. A 66-years-old female patient received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunisation . Medical history included blood pressure measurement on an unknown date. The patient had been up all night long freezing, shaking; had to take a hot bath just to warm up on 24Dec2020 with outcome of unknown , every time she got up, she got light headed on 24Dec2020 with outcome of unknown , she had Covid back in March and she felt the same way except the breathing is normal on 24Dec2020 with outcome of unknown , very weak on 24Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on Mar2020. Information about Lot /batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/24/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure; COVID-19,,,"['Asthenia', 'Dizziness', 'Feeling abnormal', 'Feeling cold', 'SARS-CoV-2 antibody test']",UNK,PFIZER\BIONTECH, 919938,NM,,F,"Drug ineffective; tested positive; chills; fever; headache; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is 2nd of two reports. A female patient of an unspecified age (30-40 year-old)started to receive bnt162b2 (BNT162B2) , via an unspecified route of administration on 02Dec2020 at single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient was tested positive to COVID-19 on 24Dec2020 after having chills, fever and a headache. The outcome of the events was unknown. The reporter stated that these were worse than just side effects. The reporter is wondering if the patient can receive the second dose. Information on the lot/batch number has been requested.; Sender's Comments: Preventive effect of BNT162b2 is documented 7 days after the 2 dose. This case does not match this requirement,Linked Report(s) : US-PFIZER INC-2020512742 different patient, same drug and event",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/02/2020,12/01/2020,,UNK,,,,,,"['Chills', 'Headache', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 919939,IN,34.0,F,"Right arm swelling; Right arm itching; injection site pain; injection site warm to touch; This is a spontaneous report from a contactable other nurse (patient herself). A 34-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine), intramuscularly at site of right arm at 16:00 on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took ciprofloxacin (CIPRO) and experienced allergies: ciprofloxacin. The patient right arm swelling and itching, injection site pain and warm to touch on 23Dec2020. No treatment received for events. No COVID prior vaccination. No COVID tested post vaccination. The outcome of events was not recovered by day 4 after the vaccination (as reported). Information about Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,,,,,,"['Vaccination site pain', 'Vaccination site pruritus', 'Vaccination site swelling', 'Vaccination site warmth']",1,PFIZER\BIONTECH,OT 919940,NJ,59.0,F,"pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; It goes up and down, feels sort of like catching the flu; This is a spontaneous report from a contactable Pharmacist reporting for herself. A 59-years-old female patient received bnt162b2 (BNT162B2) vaccine , intramuscular in the left upper arm on 23Dec2020 10:30 at single dose for Covid-19 immunisation . Medical history included ongoing hypertension , Covid-19 from 25Mar2020 to an unknown date treated with azithromycin. In Jun2020 she had antibodies against COVID-19. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE). The patient experienced pain/soreness at the injection site, swelling, chills, muscle and body aches, headache and feels sort of like catching the flu on 23Dec2020 with outcome of not recovered. The soreness started about 4 hours after the injection and during that night it progressed with the chills and body/muscle aches. Did take Tylenol to help and took it throughout the night and the day after and drinking fluids. Stated if condition goes on much longer or worse then she will have to go to the hospital. Lot/Batch and Expiration date has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,,Hypertension,Medical History/Concurrent Conditions: SARS-CoV-2 infection,,,"['Chills', 'Headache', 'Influenza like illness', 'Myalgia', 'Pain', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 test', 'Swelling', 'Vaccination site pain']",UNK,PFIZER\BIONTECH,OT 919941,GA,30.0,M,"Starting the day after I got flu like symptoms. Headache, night sweats, chills. Starting last night, after sweating an obscene amount, I started feeling dizziness. Not a normal dizziness, but a severe one with brain zaps. The type of brain zaps someone has when coming on or off affexor/venlafaxine (which I?m currently on). The dizziness only happens when I stand and the brain zaps happen more frequently than when the dose changes or is forgotten with the snri. Before someone asks... yes... I?m taking my affexor properly and haven?t changed how I?m taking it since my covid shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,MIL,Valtrex when needed for cold sores. Venlafaxine 150mg extended release daily for anxiety,None,,,Nka,"['Chills', 'Dizziness postural', 'Headache', 'Hyperhidrosis', 'Influenza like illness', 'Night sweats']",1,PFIZER\BIONTECH,IM 919942,MI,39.0,F,"feeling really dizzy; Blood pressure was kind of high; Chills; Feeling little cold; Pulse was like 100; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL0140), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 vaccine. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL). The patient was feeling really dizzy, and it started maybe like 5 to 7 minutes after received it, and patient laid in a room and blood pressure was kind of high and patient was feeling chills and little cold and pulse was like 100. Treatment in response to the adverse events included fluids just like water and juices. Patient drank like 2 or 3 juices and a bottle of water and laid down in the bed at the hospital probably for about an hour. Due date for next shot for patient was 12Jan2021. Outcome of events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,PVT,TYLENOL,,,,,"['Blood pressure measurement', 'Chills', 'Dizziness', 'Feeling cold', 'Heart rate', 'Heart rate increased', 'Hypertension']",UNK,PFIZER\BIONTECH, 919943,PR,41.0,F,"On the morning at 6:00 am of the de after the vaccination, patient woke up with pain in her body and headaches, with nausea and vomiting and a tight chest sensation. The doctor gave the order of solumedrol 80mg IV, TORADOL 30MG IV, TORADOL 30MG Im, Zofran 4 IV and .9 NSS 500mL IV. Afterwards the patient was discharged from the emergency room.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,"Protonix 10mg daily, pepcid 10 mgHs, Vitamina D 5mg, multivitamina","Esofagitis, hipoglicemia",Unknown.,,"Sulfa, percocet, tramadol, Benadryl","['Chest discomfort', 'Headache', 'Nausea', 'Pain', 'Vomiting']",1,PFIZER\BIONTECH,IM 919944,AZ,,M,"rash on his bilateral flank; This is a spontaneous report from a contactable healthcare professional (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash on his bilateral flank on 23Dec2020. It doesn't itch and within 24 hours was beginning to subside. The outcome of the event was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/23/2020,2.0,UNK,,,,,,['Rash'],UNK,PFIZER\BIONTECH, 919945,CA,49.0,F,"left eye swelling; there is a sensation to touch like a little bit of pain; left eye there is some puffiness; harsh soreness around her both temples and her face; Neck pain; Headache/harsh soreness around her both temples; Feverish; Nausea; Joint pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 49-Year-Old Female patient received BNT162B2 (lot number: EH9899, expiration date: Mar2021) on the 21Dec2020 on deltoid left at single dose to prevent COVID 19. Medical history included Hypertension and Rheumatoid arthritis. Concomitant medications included losartan for Hypertension and hydroxychloroquine sulfate (PLAQUENIL) for Rheumatoid arthritis. She was experiencing a few side effects that are on the list. However, the one that is not on there and she have never had them before. She think that it is something with her left eye there is some puffiness and there is a little bit of swelling and there is a sensation to touch like a little bit of pain when you touch it. It actually started yesterday (22Dec2020) and she took the vaccine two days ago (21Dec2020) and it is on the same side as her injection. So it is on her left side on her left eye and the injection was given on her left Deltoid. It seems to be getting a little better now though the sensation by touch is not as much as it was this morning or yesterday. So she think like it is like going away but it is just something that she think may be should be looked at as one of the possible side effect. She did get neck pain, headache, and bit of headache. She think she was a little bit feverish and nausea and joint pain and a lot of fatigue. She had a harsh soreness around her both temples and her face was like when smile or laugh it was sore. Patient took Ibuprofen to help with the soreness and the pain. It was 800mg. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/01/2020,,UNK,; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE],,Medical History/Concurrent Conditions: Hypertension; Rheumatoid arthritis,,,"['Arthralgia', 'Eye swelling', 'Facial pain', 'Fatigue', 'Headache', 'Hyperaesthesia', 'Nausea', 'Neck pain', 'Periorbital swelling', 'Pyrexia']",UNK,PFIZER\BIONTECH, 919946,FL,32.0,M,"I just woke up with like a sore and itchy throat; I just woke up with like a sore and itchy throat; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 23Dec2020 at a singe dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient just woke up with like a sore and itchy throat on 24Dec2020. The patient was trying to get information if that is a possible side effect of that or if he should be worried about something else. The patient was due for the next shot on 13Jan2021. Outcome of the events was unknown. No treatment was given for the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/24/2020,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Oropharyngeal pain', 'Throat irritation']",UNK,PFIZER\BIONTECH, 919947,NY,26.0,F,"I am 20 weeks, 4 days. I am due may 20th, 2021. I got the vaccine at work and felt fine. I was getting in my pajamas for the night and my husband noticed a weird rash on my body. It did not itch or hurt. I took a shower and a Tylenol and went to bed. I woke up at 5am the next morning and it was completely gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Prenatal vitamin,No,No,,Cipro and sulfa drugs,['Rash'],1,PFIZER\BIONTECH,IM 919948,PA,43.0,F,"About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; This is a spontaneous report from a contactable other healthcare professional, the patient. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Dec2020 at 13:00 (at the age of 43 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included supraventricular tachycardia, asthma, seasonal and environmental allergies, anxiety, and allergies to latex, adhesives, ragweed, and Keflex. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included buspirone hydrochloride (BUSPAR), piroxicam (PAXIL), cannabidiol, and levosalbutamol hydrochloride (XOPENEX), all for unknown indications from unknown dates and unknown if ongoing. Past drug history included epinephrine for dental work, where she experienced a similar reaction. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 21Dec2020, about 2-3 minutes after her vaccination, the patient experienced heart rate went up, pounding, she got dizzy, and dry mouth. She never had a hard time swallowing, no rash. This episode went on for about 2-3 minutes, they provided her a large amount of juice which seemed to help. Then it resolved completely and she finished off her 15 minutes without issue. It happened very suddenly and unexpectedly. The clinical outcome of about 2-3 minutes after her vaccination, her heart rate went up, pounding, she got dizzy, and dry mouth was recovered on 21Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,BUSPAR; PAXIL [PIROXICAM]; ; XOPENEX,,Medical History/Concurrent Conditions: Adhesive tape allergy; Anxiety; Asthma; Environmental allergy; Latex allergy; Ragweed allergy; Seasonal allergy; Supraventricular tachycardia,,,"['Dizziness', 'Dry mouth', 'Heart rate', 'Heart rate increased', 'Palpitations']",1,PFIZER\BIONTECH, 919949,,,F,"tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the COVID vaccine on Wednesday this week (23Dec2020) and she tested positive for COVID yesterday (25Dec2020). She wanted to know if she should take the second dose of the vaccine. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/25/2020,2.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 919950,NY,57.0,F,"99 fever , major fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/20/2020,4.0,PVT,"Tasigna, Plaquenil, Sulfasalizine, Synthroid, crestor, baby aspirin Vit d3 vit b12",CML RA,CML RA,,no,"['Fatigue', 'Pyrexia']",UNK,PFIZER\BIONTECH, 919951,,,F,"I received the covid-19 vaccine and then afterwards contracted covid-19; I received the covid-19 vaccine and then afterwards contracted covid-19; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 vaccine. The patient medical history and concomitant medications were not reported. The patient stated on an unspecified date, ""I received the covid-19 vaccine and then afterwards contracted covid-19. I was told by my hospital that because of this I needed to defer the second dose for 90 days. Is this best practice? Or should I take the second dose in 3 weeks as scheduled?"". The outcome of the events was unknown. Information on the batch/lot number has been requested.; Sender's Comments: BNT162b2 provides protection against COVID-19 seven days after the second dose is administered. This case does not match this condition",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PVT,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 919952,FL,61.0,M,"itch on inner thighs bilaterally/raising up both groins and onto my flanks/risen up to the level of my ribs and around my back/rose up onto both arms/itching was down to my forearms and hands; developed an itch on my inner thighs bilaterally. Scratching produced raised welts; This is a spontaneous report from a contactable nurse, the patient. A 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, via intramuscular on 22Dec2020 at 07:00 (at the age of 61 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history was none. Prior to the vaccination, the patient was not diagnosed with COVID-19. No known allergies. Concomitant medication included amoxicillin, unspecified multivitamin, triple omega, turmeric, and ibuprofen all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 23Dec2020 at 20:00 he developed an itch on his inner thighs bilaterally. Scratching produced raised welts. He treated with cortisone cream and went to bed. At about 3AM he woke up with more itching. The itching was raising up both groins and onto his flanks again bilaterally. At 5AM when he got up for work it had risen up to the level of his ribs and around his back with minimal itching on his thighs where it started. As the day progressed the itching rose up onto both arms as the itching subsided in the lower areas. He took a benadryl 25 mg that night to sleep. By the next morning (72 hours post injection) the itching was down to his forearms and hands. These symptoms were mostly resolved at this point with some minor itching of my hands. The clinical outcome of 'developed an itch on my inner thighs bilaterally. Scratching produced raised welts' was recovered, and 'itch on inner thighs bilaterally/raising up both groins and onto my flanks/risen up to the level of my ribs and around my back/rose up onto both arms/itching was down to my forearms and hands' was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,; TRIPLE OMEGA 3 6 9;,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,OT 919953,,22.0,F,"Fatigue, weakness, chills, sweats, headache. Soreness around injection site. No treatment. Went away with time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,WRK,"Zoloft, birth control",,,,,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Injection site pain']",1,MODERNA,SYR 919954,OH,50.0,F,"tested positive for Covid; tested positive for Covid; No symptoms at present time; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EV1685) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history included Covid-19 12 weeks before 25Dec2020. The concomitant drug was reported as levothyroxine sodium (SYNTHROID), hydrochlorothiazide and vitamins. The patient got the vaccine (Covid 19 Vaccine) on 22Dec2020 (Tuesday) and then on 25Dec2020 (today) had to be tested at work and was tested positive for Covid. So, she was wondering if that might have something to do with the vaccine or it was not for sure. Patient had already had Covid once and this is the first time she got tested since for 12 weeks. It just happened to be three days after the vaccine. So, the lady she work with told her a study was done and people were shown to test positive like two days after they got the vaccine. So, that's what she wanted to find out. If that could be."" She states the test on 25Dec2020 was a routine follow up Covid-19 test. No symptoms at present time. The outcome of the events was unknown.; Sender's Comments: BNT162b2 provides protection against COVID-19 after 7 days from the second dose. This case does not match this condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/25/2020,3.0,UNK,; SYNTHROID,,Medical History/Concurrent Conditions: COVID-19 (She states she had Covid-19 12 weeks ago),,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 919955,OH,51.0,M,"Patient has had a fever and flu like symptoms for over 3 days; Patient has had a fever and flu like symptoms for over 3 days; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: Ek5730, via intramuscular, on 18Dec2020 at 09:15 (at the age of 51 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included other vaccine (not specified) on 03Dec2020. The vaccine was given at a hospital. On Dec2020, the patient experienced had a fever and flu like symptoms for over 3 days. The event resulted in emergency room visit. No treatment was received for had a fever and flu like symptoms for over 3 days. The clinical outcome of had a fever and flu like symptoms for over 3 days was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/01/2020,,PVT,,,,,,"['Influenza like illness', 'Pyrexia']",1,PFIZER\BIONTECH,OT 919956,PA,30.0,F,"severe arm pain, swollen lump in arm, feverish with no fever, chills, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"lebatalol, zoloft, multivitamin, topamax",none,"hypertension, asthma, obesity",,surgical tape,"['Mass', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,SYR 919957,CA,35.0,F,"Swelling and redness an inch below injection site. Tenderness and site is warm to touch.; Swelling and redness an inch below injection site. Tenderness and site is warm to touch.; Swelling and redness an inch below injection site. Tenderness and site is warm to touch.; Swelling and redness an inch below injection site. Tenderness and site is warm to touch.; This is a spontaneous report from a contactable Nurse reporting for herself. A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number EJ1685, via an unspecified route of administration on 22Dec2020 08:00 as a single dose in the left arm (Dose number: 1) for COVID-19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. There were no other vaccines received by the patient within 4 weeks prior to the COVID-19 vaccine. Medical history included diagnosed with COVID-19 on an unknown date prior to vaccination. There were no allergies to medications, food, or other products. Concomitant medication included atorvastatin (ATORVASTATIN), ethinylestradiol, norgestimate (TRI LO MILI), and vitamin D2 (VITAMIN D2). On 24Dec2020 at 16:00, the patient experienced swelling and redness an inch belowinjection site, tenderness, site was warm to touch, and commented ""it's 4 days already after vaccination date"" (as of reporting on 26Dec2020). There was no treatment received for the events. The clinical outcome of the events swelling and redness an inch below injection site, tenderness, and site was warm to touch was not recovered. The patient was not COVID tested post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/24/2020,2.0,PVT,; TRI LO MILI; VITAMIN D2,,Medical History/Concurrent Conditions: COVID-19 (diagnosed prior to vaccination),,,"['Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling', 'Vaccination site warmth']",1,PFIZER\BIONTECH, 919958,,,M,"severe body ache; a burning itching sensation in his back; a burning itching sensation in his back; This is a spontaneous report from a non-contactable nurse (patient's spouse). A male patient of an unspecified age received bnt162b2, via an unspecified route of administration on 22Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient started to experience side effects on 23Dec2020 including severe body aches and a burning itching sensation in his back. He has had no fever. She was wondering how long symptoms usually last. And if he should be tested for Covid because she was exposed. The outcome of the events was unknown. No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/23/2020,1.0,UNK,,,,,,"['Burning sensation', 'Pain', 'Pruritus']",1,PFIZER\BIONTECH, 919959,MI,22.0,F,"Developed mild itching that turned into wide spread, severe itching and pain. Given benedryl and tylenol per peer RN recommendations. Improved, but ongoing",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PVT,"Lexapro, Wellbutrin, Prevacid, Famotidine, oral contraceptives",,"Rheumatoid Arthritis, GERD, Obesity",,"Bees, Gabapentin","['Pain', 'Pruritus']",1,MODERNA,IM 919960,TX,29.0,F,"Painful and swollen axillary lymph nodes on the same side as the vaccine; This is a spontaneous report from a contactable other hcp (patient). A 29-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the right arm on 17Dec2020 15:00 at a single dose for COVID-19 immunization at the hospital. The patient's medical history was not reported. The patient has no known allergies. Concomitant medication included ethinylestradiol, ferrous bisglycinate, levonorgestrel (BALCOLTRA) and ibuprofen. The patient did not receive other vaccine within four weeks prior to COVID vaccine.The patient experienced painful and swollen axillary lymph nodes on the same side as the vaccine on 25Dec2020 10:00. The event led a clinic visit to the doctor or other healthcare professional office. It was unknown if treatment was given. Outcome of the event was not recovered. The event was assessed as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. Information on the Lot/Batch Number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/25/2020,8.0,PVT,BALCOLTRA;,,,,,['Lymphadenopathy'],1,PFIZER\BIONTECH,OT 919961,NY,55.0,F,"Full body joint pain, muscle pains, low grade fever, headache, pain, redness and swelling at injection site. Two days after injection, injection site became itchy as I complete this form injection site still itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,"Losartan 100 mg, glucosamine, latnoprost eye drops, alphagon, cosopt PF",none,hypertension & glaucoma,,none,"['Arthralgia', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 919962,CT,39.0,F,"Fever, chills, nausea, headache, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Birth control pills Crestor,,Sinus tachycardia,,Bactrim,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 919963,OK,62.0,M,"Right arm soreness Dec 24 , Fatique on Dec 25 , Severe Chills DEC 26 and fever of 101.5",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,"Methotrexatete , Alodipine , Testrone ,a statan don't know name ,Methocarbole ,Gabapin , tramoadole",None,Arthritic right hip replaced 1 year ago left hip is being replaced in March 2021,Swine flue shot Nov 1976,"Pennicllin , codine","['Chills', 'Fatigue', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 919964,FL,50.0,M,"Body aches, severe fatigue, Temp 101.2F, persistent head ache, slight nausea. Symptoms resolved by post-vaccine day 3.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,None,None,None,,None,"['Body temperature increased', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 919965,NC,45.0,F,"dizzinessand lightheaded; Vision slightly blurred; BP elevated to 144/96; Slight nausea for remainder of day; This is a spontaneous report from a contactable nurse reporting for herself. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Dec2020 14:00 at a single dose for COVID 19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. There was no other vaccination administered in the 4 weeks prior to COVID-19 vaccination. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. There were no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported; the patient did receive other medications within 2 weeks prior to COVID-19 vaccination.The patient experienced dizziness and lightheaded, noticed about 30 minutes after vaccine. Vision slightly blurred. BP elevated to 144/96. Slight nausea for remainder of day. The events occurred on 23Dec2020 at 14:45 pm. No treatment was received for the events. The patient recovered from the events dizziness, lightheaded, vision slightly blurred, BP elevated to 144/96, and slight nausea on an unknown date in Dec2020. The patient was not COVID-tested post vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Multiple sclerosis,,,"['Blood pressure increased', 'Blood pressure measurement', 'Dizziness', 'Nausea', 'Vision blurred']",UNK,PFIZER\BIONTECH, 919966,PA,44.0,F,"lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; developed a cough once the numbness and tingling reached my throat; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration at the left arm on 18Dec2020 15:30 at a single dose for COVID-19 immunization. Medical history included thyroidectomy for thyroid cancer, anaphylaxis to mangoes and allergic to multiple medications. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine and liothyronine. The patient received the vaccine at 3:30pm, ten minutes later her lips, tongue and throat became numb and tingly. She developed a cough once the numbness and tingling reached my throat. She was given Benadryl at the time, 15 minutes after injection. She was still having numbness and tingling to the back of her tongue currently (8 days after injection). The patient was not hospitalized for the events. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,;,,Medical History/Concurrent Conditions: Drug allergy; Fruit allergy; Thyroid cancer; Thyroidectomy,,,"['Cough', 'Hypoaesthesia oral', 'Paraesthesia oral', 'Pharyngeal hypoaesthesia', 'Pharyngeal paraesthesia']",1,PFIZER\BIONTECH, 919968,TX,43.0,F,"rash; shingles; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable nurse reported that a 43-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced developed a rash and shingles in Dec2020. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/01/2020,,UNK,,,,,,"['Herpes zoster', 'Rash']",UNK,PFIZER\BIONTECH, 919969,LA,,M,"stuffy nose; cough; This is a spontaneous report from Pfizer-sponsored program Pfizer First Connect. A contactable physician reported for himself that a 66-year-male received first dose (BNT162B2) , intramuscular at arm in Dec2020 at single dose for COVID-19 immunization. The medical history included High Blood Pressure, Cholesterol and chills. The patient was a physician who reported being exposed to Covid 19 via his daughter. He completed a PCR test which was negative and received his vaccine at work a few days later. After receiving the vaccine he had a stuffy nose and cough and completed an antigen test which was positive in Dec2020. He was given monoclonal antibodies the same day as his positive test. He is supposed to take the second dose of the vaccine 11Jan2021. The background was on Thursday he had a PCR 5 days after possible exposure, so he stepped forward for vaccine on Monday, so he got the vaccine on Monday and usual chills and all that stuff that went away. He went to work on Tuesday and was little stuffy so he went downstairs to get the rapid test, he had cough too and they have been developing for several days. He went downstairs to go rapid test and it was positive and he didn't conform with the PCR. (word incomprehensible) around 9 percent so used to get 20 percent false positive so he got the infusion. The patient underwent lab tests and procedures, which included antigen test positive in Dec2020, PCR test negative in Dec2020. The outcome of the events was unknown. The information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure high; Chills; Cholesterol,,,"['Cough', 'Nasal congestion', 'Polymerase chain reaction', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 919970,WV,58.0,F,"Normal redness swelling soreness of arm which resolved after couple days along with other normal normal reactions, myalgia, low grade fever etc. However about one week to the day, 12/31/20 same ~6 cm circ red itchy sore are reappeared on arm and is still here 1/5/20. It may be starting to fade some. Just wanted to let you know. No action desired.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PUB,"topamax, toprol, prozac, omeprazole, citicoline, niacinamide, vit d, zinc, azor",none,"gerd, htn, obesity, migraine",,penicillin,"['Erythema', 'Myalgia', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Pyrexia']",UNK,MODERNA, 919971,CO,53.0,F,"heart began racing; dizziness/lightheaded; felt foggy; became winded/short of breath; felt an adrenaline rush; Nasal congestion started after 30 min; within 3 min after injection, became flushed; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 19Dec2020 07:30 AM at left arm, at single dose for covid-19 immunization. Medical history included Type 1 diabetes, hx of anaphylaxis to allergy shots and allergies to Latex, avocados, fluorescein dye (anaphylaxis), cats/dogs, environmental. Concomitant medication included ascorbic acid (VIT C), ergocalciferol (VIT D), fexofenadine hydrochloride (ALLEGRA), insulin lispro (HUMALOG), tocopherol (VIT E). The patient was not pregnant at the time of vaccination. Within 3 min after injection, the patient became flushed from 19Dec2020 07:33 AM; heart began racing, dizziness, lightheaded, felt foggy, became winded/short of breath and felt an adrenaline rush, was observed by med personnel x 30min from 19Dec2020 08:00 AM. Nasal congestion started after 30 min on 19Dec2020 08:00 AM. No treatment was received for all events. These events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,VIT C; VIT D; ALLEGRA; HUMALOG; VIT E [TOCOPHEROL],,Medical History/Concurrent Conditions: Allergy to animal; Allergy to chemicals; Anaphylaxis; Environmental allergy; Fruit allergy; Latex allergy; Type 1 diabetes mellitus,,,"['Agitation', 'Dizziness', 'Dyspnoea', 'Feeling abnormal', 'Flushing', 'Heart rate', 'Nasal congestion', 'Palpitations']",1,PFIZER\BIONTECH, 919972,,27.0,F,"received the vaccine on Friday and tested positive; received the vaccine on Friday and tested positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable other healthcare professional. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration in Dec2020 (reported as on Friday) at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine on Friday and tested positive today 26Dec2020. The outcome of event was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event COVID-19 virus test positive based on the known safety profile.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 919973,MI,26.0,F,"Shot was given around 12:40 pm on 1/4/2021. I woke up with shivers and low grade fever (99.6) at about 11:30pm. Took a Tylenol at that time. Low grade fever still persists (and rose to 100 degrees at the highest), mild body aches at 6am and headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,Yasmin birth control Magnesium 400mg daily,None,None,,None,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 919974,CA,31.0,M,"Sinus Infection (sneezing & runny nose); Sinus Infection (sneezing & runny nose); headache; fatigue; Sinus Infection (sneezing & runny nose); Sinus infection was reported as worsened; This is a spontaneous report from a contactable other health professional reporting for himself. A 31-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot# Lot EH9899), intramuscular in left arm, on 23Dec2020 at 12:00 PM, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced sinus infection (sneezing & runny nose) on 25Dec2020 at 12:00 PM with outcome of not recovered, headache on 25Dec2020 12:00 PM with outcome of not recovered, fatigue on 25Dec2020 at 12:00 PM with outcome of not recovered. The event sinus infection was reported as worsened in Dec2020 with outcome of unknown. No therapeutic measures were taken as a result of the events. The events were considered as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/01/2020,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Condition aggravated', 'Fatigue', 'Headache', 'Rhinorrhoea', 'Sinusitis', 'Sneezing']",1,PFIZER\BIONTECH,OT 919975,,,F,"Slight fever (99.3); muscle/joint aches; muscle/joint aches; congested cough; tachypnea; nausea; malaise for about 12 hours 60 hours; This is a spontaneous report from a non-contactable nurse. An adult female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), intramuscular on 22Dec2020 11:00 at single dose at left arm for COVID-19 immunization. Medical history was none, no known allergies. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Dec2020 23:00 (11:00 PM), the patient experienced slight fever (99.3), muscle/joint aches, congested cough, tachypnea, nausea, malaise for about 12 hours 60 hours after injection. The events were non-serious per the reporter. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovered in Dec2020. No follow-up attempts are possible. Information about lot/batch number could not be requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Body temperature', 'Cough', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia', 'Tachypnoea']",UNK,PFIZER\BIONTECH,OT 919976,DC,44.0,F,Swollen arm. Redness of arm. Erythematous patch,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,Aimovig. Excedrin migraine,Migraines,Migraines,,None,"['Erythema', 'Peripheral swelling', 'Rash erythematous']",UNK,MODERNA, 919977,NY,28.0,M,"sinus like symptoms/ bad runny nose; sinus like symptoms/ congestion/ sinus congestion; Itchiness; chills; body ache; head ache; This is a spontaneous report from a contactable other health professional (patient). A 28-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), intramuscularly on 23Dec2020 at single dose for COVID-19 immunization because he work in a hospital. Medical history was reported as none. There were no concomitant medications. The patient reported to have been vaccinated last Wednesday and developed symptoms on Thursday (24Dec2020) with a pretty bad chills, body ache, headache, itchiness, then got sort of better and that was on Thursday. He felt better on Friday (25Dec2020) but reported a really bad runny nose and congestion, he started to develop sinus like symptoms like runny nose, like sinus congestion and that's so something that he was experiencing like 26Dec2020 to Saturday. The patient was asking if these were the typical symptoms/ normal reaction to the vaccine and if he had that reaction were normal and how long would they usually last. The outcome of chills, headache, itchiness was recovering, of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No",,,"['Chills', 'Headache', 'Pain', 'Pruritus', 'Rhinorrhoea', 'Sinus congestion']",1,PFIZER\BIONTECH, 919978,,,U,"Bruise on antecubital area, kind of spreading a little bit to plexus like the extensor muscle on forearm; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2, lot number: EL1284, via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the COVID Vaccine yesterday as a 'healthcare worker' and noticed three hours ago (Dec2020), that he/she had bruise on the antecubital area and then it was kind of spreading a little bit to the plexus like the extensor muscles on the forearm. Patient was just wondering if this was part of the side effect. The patient has not yet recovered from the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/01/2020,,UNK,,,,,,['Contusion'],UNK,PFIZER\BIONTECH, 919979,NJ,59.0,M,"Extreme fatigue, injection site soreness, body ache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,PUB,"Wellbutrin, jardiance, glipizide, glucophage, trazadone, multivitamin, iron.",None,"Diabetes, sleep apnea, carpal tunnel",,"Plums, pollen, ragweed, dust.","['Fatigue', 'Injection site pain', 'Pain']",1,MODERNA,IM 919980,NY,48.0,F,"I can't even read; I'm so freaking sick /I didn't feel well; Flu / like flu side effect; I still feel like very weak and achy; Pain/achy/aches; Teeth chattering; Shaking all night long and 102 fever; Shaking all night long and 102 fever/low grade fever; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, reason for no lot number: consumer stated, ""I can't even read, it says EK or E something 5730. That's what it looks like.""), intramuscular in arm in Dec2020 at single dose for COVID-19 immunisation. Medical history included low thyroid, have had thyroid cancer many years ago. Concomitant medication included levothyroxine sodium (SYNTHROID). Consumer stated, ""I just have a question, I had a shot done on Wednesday and I have heard the second shot was worst so I was little concern we are all concerned about getting the first shot to begin with. So I had the shot on 11:30 at work at the hospital on Wednesday. I probably about 1:30 to 2 O'clock in the morning total like flu side effect. I thought I got a flu, aches, pain, teeth chattering, shaking all night long and 102 fever. I haven't been sick at all thank god in a while but it feels like I had, so, I have a new born grandson supposed to go there for Christmas so I'm concerned because I was running a 102 Wednesday night and I was so running a low grade so is it normal to have reaction like that?"" Consumer stated, ""Yes, let me just get a pen. I just don't want to be around the baby. I thought I was fit but I don't usually when your body gets the vaccination your body fighting against the vaccine so I don't think it is going to affect the baby. I just don't want to get this shot if they got affected and if they are on fever. I just want to make sure before I go over there for Christmas."" When probed if calling for the first time in Pfizer drug safety department, consumer stated, ""No, actually I was just thinking now before I had out I grab these side effects yesterday and I read it I have fever 102, I was like let me call the number from the paper that they gave me with the shot card, let me call you guys and try to figure out what the hell is going on here and why I'm so freaking sick from this shit."" .Height and weight: Consumer stated, ""I say about 130 and about 5'6."". LOT#: Consumer stated, ""Let me see if I have the card, I know I have it somewhere. May be I'm just thinking I shouldn't get the second shot. I can't even read. it's Pfizer, I can't even read, it says EK or E something 5730. That's what it looks like.""Manufacturer name: Consumer stated, ""Covid 19 Vaccine and I'm pretty sure it's Pfizer."".Lab work: Consumer stated, ""I had all my labs on like you know like regular labs CBC's like everything. I have bad thyroid it goes up and down, I didn't feel well so I went to you know I know when my thyroid is up or down so I went and got the whole blood panel done."".Date of administration of first dose: Consumer stated, ""It was probably like December 8th. I had it done on 23rd of December."" (Not further clarified).Event date: Consumer stated, ""The same day I had the shot."".When probed if still experiencing the events, Consumer stated, ""Yes. It's not totally improved but it is better than it was but I still feel like very weak and achy."" .Treatment: Consumer stated, ""Tylenol and Ibuprofen I keep alternating it.""Consumer stated, ""I just want to make sure I can go back to my grandson today because I went to my daughter last time she is leaving for (place name) tomorrow and she was nervous and now I'm like still running a low grade fever last night and I know my daughter is going to flip out if I show up. I told her it's okay because it's only vaccination but I just want to make sure with the Covid shot I got."" .The outcome of events I still feel like very weak and achy and pain/achy/aches was not recovered. The outcome of events flu / like flu side effect, teeth chattering, shaking all night long and 102 fever, shaking all night long and 102 fever/low grade fever, I'm so freaking sick was Recovering. The outcome of other events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/01/2020,0.0,PVT,SYNTHROID,,Medical History/Concurrent Conditions: Thyroid cancer (I have had thyroid cancer many years ago); Thyroid function decreased,,,"['Asthenia', 'Blood test', 'Body height', 'Body temperature', 'Chills', 'Full blood count', 'Influenza like illness', 'Malaise', 'Pain', 'Pyrexia', 'Tremor', 'Visual impairment', 'Weight']",1,PFIZER\BIONTECH,OT 919981,PA,35.0,F,"Bleeding bilaterally of both sides of lower gums between cheeks and inside part of lower lip; kind of pooling of blood in bottom of mouth; went through several tissues; Mild arm pain; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in the left deltoid on 24Dec2020 at a single dose for COVID-19 immunization. Medical history included anxiety. Concomitant medication included sertraline for anxiety. The patient received the first dose of the COVID-19 vaccination at the time of report and wanted to report of a probable side effect that she had about an hour and a half after she got the vaccination. About an hour and a half after she received the vaccination, she started to experience bleeding from gum both sides, bilaterally of both sides of lower gums between cheeks and then also from the inside part of lower lip that lasted for about 3 to 4 minutes. It wasn't necessarily profuse bleeding but it was significant enough to cause pooling, kind of pooling of blood in the bottom of my mouth. And she went through several tissues and then it just spontaneously resolved on its own and haven't had any bleeding since. The patient had them 24 hours but didn't have any further bleeding episodes from anywhere. Since that time, the patient haven't noticed any other symptoms other than some mild arm pain. The bleeding has stopped, it stopped after about 3 to 4 minutes and arm pain kind of persisted but not worsened, not terribly bothersome. No treatment was given for the events. The patient wanted to understand if this is a side effect that's being reported by anybody and also whether a recommendation if she should still get this. Outcome of the event gum bleeding was recovered in Dec2020; event mild arm pain was not recovered. The reporter assessed the events as related to COVID-19 vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Anxiety,,,"['Gingival bleeding', 'Pain in extremity']",1,PFIZER\BIONTECH,OT 919982,ME,29.0,F,"Moderna COVID-19 Vaccine EUA Injection site redness, swelling, itching, discomfort the size of a fist 7 days after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/04/2021,7.0,PVT,Sertraline 65mg Vitamins D 1000mg Vitamins B Complex,,,,,"['Injection site discomfort', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 919983,,,M,"fatigue; sneezing; runny nose; Headache; Sinus infection; This is a spontaneous report from a contactable other HCP (patient). A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller reported to had taken the vaccine 3 days before (23Dec2020) and showed symptoms of fatigue, sneezing, and runny nose roughly after 48 hours (on 25Dec2020) and had been getting worse. He was asking for any recommendations such as testing and what to do next. Consumer stated that he was just calling because he got the vaccine 3 days before (23Dec2020) and he was having few side effects. He didn't know if they were related or not but he was wondering if he need to get tested or not. He was having sinus infection (in Dec2020), he have pretty heaving runny nose, sneezing, headache and fatigue in Dec2020. The outcome of the events was unknown. Information on the Lot/Batch Number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/01/2020,,UNK,,,,,,"['Fatigue', 'Headache', 'Rhinorrhoea', 'Sinusitis', 'Sneezing']",UNK,PFIZER\BIONTECH, 919984,TX,46.0,F,"tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms; tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 20Dec2020 at single dose for covid-19 immunization. Vaccine location was left deltoid. The facility type vaccine was hospital. Medical history included polycystic ovarian diseases from an unknown date. Concomitant medication included metformin, omeprazole, apremilast (OTEZLA). Patient stated she got the vaccine on the 18th. She took the vaccine on 20Dec2020. Yesterday (25Dec2020) she started to feeling sick and today (26Dec2020) patient got tested and she have Covid. She reported to have tested positive for COVID today (26Dec2020) with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms yesterday at around 4:00pm. This was the first time she has taken the Covid test. The physician stated she didn't know the causality between the event and vaccine. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive test for COVID based on the known safety profile. However the short duration of 5 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/25/2020,5.0,PVT,; ; OTEZLA,,Medical History/Concurrent Conditions: Polycystic ovarian syndrome,,,"['Asthenia', 'COVID-19', 'Influenza like illness', 'Malaise', 'Nasal congestion', 'Oropharyngeal pain', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 919985,OH,26.0,F,"Got the vaccine around 9:20-9:30 am, experienced a sore arm and headache a few hours later and some body aches. Woke up in the middle of the night with chills- fever Of 101, nausea, dizziness, headache, sore arm, and body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,UNK,Took half a unisom- otc sleeping pill the night of the vaccination,None,None,,None,"['Chills', 'Dizziness', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA, 919986,CA,35.0,F,"Pain on the right side of my head; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient started to receive BNT162B2 (lot number: EH9899), via an unspecified route of administration on 21Dec2020 at SINGLE DOSE for exposure to COVID. There were no medical history. Concomitant medication included ibuprofen (ADVIL) and unspecified birth control. The patient experienced pain on the right side of her head on an unspecified date. No treatment received for the event. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,,,UNK,ADVIL [IBUPROFEN],,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No",,,['Headache'],UNK,PFIZER\BIONTECH, 919987,PR,32.0,F,"PALPITATIONS, HIGH BLOOD PRESSURE, NAUSEA AND DIZZINESS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Dizziness', 'Electrocardiogram', 'Hypertension', 'Nausea', 'Palpitations']",UNK,MODERNA,IM 919988,IL,,F,"he felt the same as when she had COVID (scratchy throat and cough); he felt the same as when she had COVID (scratchy throat and cough); This is a spontaneous report from a contactable nurse. This nurse is reporting similar events for two patients. This is the second of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. The patient medical history included COVID. Concomitant medications were not reported. It was reported that the patient got the vaccine (COVID 19 Vaccine) same day and was saying that she felt the same as when she had COVID (scratchy throat and cough) on Sunday (20Dec2020).. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020514115 same reporter, same drug, same event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/20/2020,2.0,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Cough', 'Throat irritation']",UNK,PFIZER\BIONTECH, 919989,,,U,"Got vaccinated and contracted COVID the following week; Got vaccinated and contracted COVID the following week; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown as the reporter did not have any of that information at the moment of reporting), via an unspecified route of administration on 15Dec2020 at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. It was reported that the patient got vaccinated on December 15th and contracted COVID the following week (Dec2020). Treatment included regeneron infusion last night (24Dec2020). Patient was wondering if zinc supplements should be taken or how to handle own's immune system because the patient had the first immunization. The outcome of the event was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/15/2020,12/01/2020,,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 919990,MN,28.0,F,"Experienced nausea, fever, chills, and body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,,,,Similar reaction with other vaccines,,"['Chills', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 919991,FL,59.0,M,"Periorbital edema more on the right than the left; Herpes labials; This is a spontaneous report from a contactable Physician (patient). A 59-years-old male patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EH9899) via an unspecified route of administration on 17Dec2020 18:45 at single dose in left arm for COVID-19 immunisation. Medical history included Hypertension, Hyperlipidemia, nocturnal seizures and known allergies: Quinolones. Concomitant medications included Atorvastatin, Gabapentin, magnesium chloride (MAG), Telmisartan and riboflavin (VIT B2). The patient experienced Periorbital edema more on the right than the left at 25Dec2020 08:00, herpes labials on 21Dec2020. The patient did not receive any treatment. Outcome of events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/21/2020,4.0,PVT,; ; MAG [MAGNESIUM CHLORIDE]; ; VIT B2,,Medical History/Concurrent Conditions: Allergy to antibiotic; Hyperlipidemia; Hypertension; Seizures,,,"['Oral herpes', 'Periorbital oedema']",1,PFIZER\BIONTECH, 919992,IL,68.0,F,"headache; nausea; vomiting; chills, rigor; fever; fatigue; This is a spontaneous report from a contactable other hcp. A 68-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly in the left arm on 24Dec2020 at 07:30 (at the age of 68-years-old) as a single dose for COVID-19 vaccination. Medical history included penicillin allergy from an unknown date and unknown if ongoing, latex allergy from an unknown date and unknown if ongoing and a thyroid disorder from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took iodine for an unknown indication and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Dec2020 at 15:30, the patient experienced headache, nausea, vomiting, chills, rigor, fever and fatigue. No therapeutic measures were taken as a result of the events. The clinical outcome of the headache, nausea, vomiting, chills, rigor, fever and fatigue was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/26/2020,2.0,PVT,SYNTHROID,,Medical History/Concurrent Conditions: Latex allergy; Penicillin allergy; Thyroid disorder,,,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,OT 919993,MD,58.0,F,"Moderna COVID-19 Vaccine EUA Fatigue, Muscle Pain, Chills, Joint Pain, Nausea x 24hrs. Headache x 3 days Pain at injection site x 4 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2000,12/29/2000,1.0,OTH,"PRN Zyrtec, Vitamin D, Calcium",None,None,,NKA,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea']",1,MODERNA,IM 919994,CA,57.0,F,"metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs; about 30 minutes developed itching and redness of both legs; Started immediately having dizziness; Right upper facial muscles started twitching around eye area; This is a spontaneous report from a contactable physician (patient). A 57-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscularly on 16Dec2020 14:00 at left arm, at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. After vaccination injection, the patient started immediately having dizziness from 16Dec2020 14:00 and then about 30 minutes developed itching and redness of both legs on 16Dec2020 14:30. About 2 hours after vaccine on 16Dec2020 16:00 went home still itching with redness, dizziness, developed mild headache and metallic taste. Right upper facial muscles started twitching around eye area. Took Benadryl and Tylenol went to sleep. Woke up 5 hours later, all symptoms gone accept still a little dizzy. By the next morning felt weird then by 24 hours everything resolved. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dizziness', 'Dysgeusia', 'Erythema', 'Headache', 'Muscle twitching', 'Pruritus']",1,PFIZER\BIONTECH,OT 919995,,,U,"had a testing, came up positive; had a testing, came up positive/sporadic coughing and a little short of breath. Maybe a little sore throat; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received Pfizer COVID Vaccine (further clarified) on 20Dec2020. And maybe two days after that, the patient kind of developed a little like very sporadic coughing, it was very mild and a little short of breath. Maybe a little sore throat so that's why the patient was concerned. The patient had a testing in Dec2020, they did swab the patient's throat, it came up positive. The outcome of events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/01/2020,,UNK,,,,,,"['Cough', 'Culture throat positive', 'Dyspnoea']",UNK,PFIZER\BIONTECH, 919996,,,M,"very sick for two days; This is a spontaneous report from a non-contactable consumer communicated to a Pfizer colleague. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the COVID vaccine and was very sick for two days. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Illness'],UNK,PFIZER\BIONTECH, 919997,CA,43.0,F,"Rushing feeling-hands turned red and warm and face turned red and warm; Rushing feeling-hands turned red and warm and face turned red and warm; redness of hands; Rushing feeling-hands turned red and warm and face turned red and warm; Palpitations-increases heart rate; Palpitations-increases heart rate; Increased blood pressure; This is a spontaneous report from a contactable Nurse. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 24Dec2020 at 04:15 (at the age of 43-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. The patient was allergic to morphine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in a workplace clinic. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 04:30 the patient experienced a rushing feeling during which her hands turned red and warm and her face turned red and warm. At this same time, she also experienced increased blood pressure, palpitations and increases in her heart. The patient did not receive any treatment for the events. The clinical outcomes of rushing feeling during which her hands and face were warm and turned red, increased blood pressure, palpitations, increased heart rate were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,WRK,,,,,,"['Blood pressure increased', 'Blood pressure measurement', 'Erythema', 'Feeling hot', 'Heart rate', 'Heart rate increased', 'Palpitations']",1,PFIZER\BIONTECH, 919998,NY,25.0,F,"Fever; body-ache; joint pain; head-ache; fatigue; light-headedness; This is a spontaneous report from a contactable consumer (the patient). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK9231), via an unspecified route of administration on 22Dec2020 at 22:30 (at the age of 25-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included COVID-19 on an unspecified date and Post COVID Inflammatory Response which resulted in exercise induced asthma afterwards (dates not specified). The patient is allergic to mangoes. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 09:00, the patient experienced fever, body ache, joint pain, headache, fatigue and light-headedness. The patient did not receive any treatment for the events. The clinical outcomes of fever, body-ache, joint pain, headache, fatigue and light-headedness were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,PVT,,,"Medical History/Concurrent Conditions: Asthma exercise induced; COVID-19 (if Covid prior vaccination: Yes/Prior to vaccination, was the patient diagnosed with COVID-19?: Yes); Food allergy; Inflammation",,,"['Arthralgia', 'Dizziness', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 919999,MO,,U,"Cough and dry throat; sore throat; Cough and dry throat; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2, via an unspecified route of administration on 18Dec2020 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced cough and sore throat on 24Dec2020 and dry throat in Dec2020. It was further reported that patient just got the vaccine on 18th and patient drove down from one city to another couple of days ago and yesterday (24Dec2020) in the afternoon, patient started feeling sore throat and a cough. Patient would like to know if it was an adverse reaction of the vaccine or was it cold. When paraphrased the concern, patient stated, ""I don't know if these are the negative side effect of the vaccine itself or there is something else like climate or something like that"". The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/01/2020,,UNK,,,,,,"['Cough', 'Dry throat', 'Oropharyngeal pain']",UNK,PFIZER\BIONTECH, 920000,MA,59.0,F,"Very tired; Cold/head cold; upset stomach; she was not feeling well; it got her all congested and she got the head cold in Dec2020; little whooping cough; I had severe headaches and it was just too uncomfortable; my head was so congested; worst headache; it was just too uncomfortable; This is a spontaneous report from a contactable consumer(patient). A 59-year-old female patient received BNT162B2 via an unspecified route of administration on 22Dec2020 at the 59-year-old at single dose for Covid virus. The medical history included Congested, head cold and Covid virus. There was no concomitant medication. The patient work at a hospital and she went for a Covid shot (clarified as Covid 19 vaccine) on 22Dec2020 and she got a very bad reaction from it which bothered her, she had severe headaches in Dec2020 and it was just too uncomfortable and on 24th she was very tired, she didn't had too much of upset stomach in Dec2020 but it was not all that bad by 9 in the clock by morning she was at work and everything and she was told by if she was not feeling well she can walk by a day, but her question and her concern was back on November okay she had called in sick around, she had a funeral that she gone too and people that were at the funeral, unfortunately were smoking outside and smoke bothers me very much, she get congested and she get head cold from it you know and I was thinking it's nothing it's just a cold and somebody told her no (name) you better go get yourself to the employee health office and get checked out and she didn't bother doing that, she said no it's just the cold she will be fine but then it just got worse down the road and she said to herself may be she better just to say she did it, so she called in sick on 24th because she had the cold still and she called and she went to employee health office on 25th she still had the headache and she still had the cold, however when she went to the health office they said to her well stay out of work and we will get back in touch with her and she said okay and she will do that so when they got back in touch with her they said they do have the Covid and she said ohhh she said okay so she stayed out of work and she went to work on the 07Dec so she was wondering whole time, so her confusion was this she was told if you already had the virus in her which at that time, she did not know what it was she just thought it was from cigarette smoke because it got her all congested and she got the head cold in Dec2020 and the whole thing that went along with it and the health employee officer know you had the virus and it's just the virus and she go oh great and that's when they told her to stay out of work and she said okay fine then she just have to that, so in the meantime everybody in the work said hi calling me checking up on her and she said it's so nice of you people, she appreciate it but then she went back to work she was still feeling you know much better than she was but she had little whooping cough in Dec2020 but that was not really that bad, so they said you going to get the shot or not, and she said she don't know she kind of debatable, she don't know if she should get it, because she work in the hospital or she should not get, she said she don't know she was kind of up and some people like she get it sometime your health was not that good but on the other hand everybody that is working here in the hospital working with patients because was work right in the ICU, all over the floor you know spreading right there so she said oh alright so she kicked myself and said go get the shot, get it just over with and get it out of here so that is when she took her shot that was on 22nd and on 24th she was very tired all day no she was tired all day but she was kind of dragging most of the day but she had on the 20th no that was fine on the 20th okay for some reason she guess it was after work that week on 19th, she came home and her head was so congested and she had the worst headache and she felt like a wand had hit her over the head, it was horrible and all she could smell was cigarette smoke, like is her neighbor smoking here so she went down the hall because in live in building that used to be hotel but now they turned that into Condominium and she walk up and down the hall and she was like was somebody smoking or why this or why smell this so strong and the all the lights off in a hallway and she don't want to offend anybody but they had to go to work and somebody elsewhere and she am like she can't stand this smell and they gave this shot and she went for this shot, and they told us to come back she think it was a week or something like that to get the second shot, and she am saying if this going to cost her going to feel this way again, she don't want to get the second shot, she told them that and they told her to call this number and talk to them.The only reason she got it because they encouraged to get it. Even though she had the Covid virus, people said if you already have the virus you don't need to get a shot but people were encouraging because that's she thought well she guess she will get it. But she was mad that she got because it made her sick in Dec2020. And because we already got it they want us to go back and get the second shot and what she was m trying to say to you is, without take and hour 3 hour of conversation here she just want to say she don't want to get back and get the second shot and if it is okay by you guys somehow send her a letter or whatever it is, whoever she have to talk to because she don't want to go back and get the second shot just because of getting sick. She took Excedrin because that works for my headache. She didn't understand why you need all this information history with all this when all she want to say was she didn't want to get a second shot. The outcome of events Head cold and Headache was not recovered, the other events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/01/2020,,PVT,,,Medical History/Concurrent Conditions: COVID-19; Head cold; Upper respiratory tract congestion (back on November okay I had called in sick around/ I get congested and I get head cold from it),,,"['Abdominal discomfort', 'Discomfort', 'Fatigue', 'Headache', 'Parosmia']",UNK,PFIZER\BIONTECH, 920001,CA,45.0,M,"Fever; body ache; Chills; Headache; This is a spontaneous report from a contactable Nurse (patient). A 45-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose to prevent COVID. Medical history included ongoing cholesterol abnormal. Concomitant medication included metformin and Cholesterol Medicine. The patient experienced Fever, body ache, Chills, Headache on 22Dec2020. Nurse stated, he have some question regarding the side effects of COVID Vaccine. He received the COVID Vaccine on 21Dec2020 (Monday), he was a nurse and knew it was normal to get fever in some cases but he has had a fever, body ache, the chills, the headaches. He did take Ibuprofen, Tylenol to cut the fever around the clock for the last three days. Nurse further stated, ""he wanted to know how long he was going to expect the fever, the chills, the body ache. It was a bit too long and started to worry him. When probed for the causality, Nurse stated, ""These are related to vaccine because he tested negative to COVID-19 on 21Dec2020 (Monday) and these symptoms started the next day after the vaccine on 22Dec2020."" Therapeutic measures were taken as a result of fever. The outcome of the events was unknown. The causality assessment for events Fever, body ache, Chills, Headache was provided as related by Reporter via Method of assessment Global Introspection.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/22/2020,1.0,PVT,,Blood cholesterol abnormal,,,,"['Chills', 'Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 920002,OR,53.0,F,"Very painful shoulder 24 hours later; pounding heart rate felt in my chest that lasted less than 30 sec; with in 5 minutes of inoculation experienced an odd taste in my mouth; Warm sensation in Left upper arm for at least 15 minutes.; This is a spontaneous report from a contactable other Health Care Professional (HCP). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Dec2020 at 13:15 (at the age of 53-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. Medical history included pneumonia, high cholesterol, eczema rashes from perfumes/beauty products/soaps and hand dermatitis all on unknown dates.The patient is allergic to amoxicillin (rash trunk) and experiences seasonal allergies in the eyes/nose/with coughing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 13:20 (reported as ""within 5 minutes of inoculation"") the patient experienced an odd taste in her mouth, a pounding heart rate felt in her chest that lasted less than 30 seconds (may have been shorter). She stated that she was trying to stay calm. Also, she experienced a warm sensation in the left upper arm for at least 15 minutes as well as a very painful shoulder twenty-four hours later; there was no swelling nor redness noted. Her shoulder was much improved by the third day.The patient did not receive any treatment for the events. The clinical outcomes of heart rate increased, taste peculiar, localized feeling of warmth and shoulder pain were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Hand dermatitis; High cholesterol; Pneumonia; Rash; Seasonal allergy,,,"['Arthralgia', 'Dysgeusia', 'Feeling hot', 'Heart rate', 'Heart rate increased']",1,PFIZER\BIONTECH, 920003,MD,,U,"The evening of the vaccine I only had about 3 hours of generalize achiness; slight generalized joint discomfort and slight burning sensation; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that: ""the evening of the vaccine I only had about 3 hours of generalize achiness (18Dec2020) and was back to normal after that. About 3 days after the vaccine I have slight generalized joint discomfort and slight burning sensation. This is not limiting my activity"". The patient outcome of generalized achiness was recovered, the outcome of slight generalized joint discomfort and slight burning sensation was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/01/2020,,UNK,,,,,,"['Arthralgia', 'Pain']",1,PFIZER\BIONTECH, 920004,,,U,"Coworker who received the shot is positive too; Coworker who received the shot is positive too; This is a spontaneous report from a contactable consumer. This consumer reporter similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient's medical history concomitant medications were not reported. The reporter's coworker who received the shot was positive too. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020513735 same reporter/product, different patient, similar event",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 920005,,,U,"I have a fever that is 100; body aches; Headache; This is a spontaneous report from a contactable consumer (patient). A patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history included covid before very, very, very, very, very bad. The concomitant was not reported. The patient work in a hospital and got her shot (Covid Vaccine) on 23Dec2020, and she have all the reactions to it in Dec2020. Patient have had Covid before very, very, very, very, very bad, it seems like she was starting all over it again. She don't feel like she was going to die or anything, she already went through all of that but patient have a fever that is 100, the body aches, the headaches the whole thing, they all starting now which patient assumed this is just temporary because she don't want to have through with this thing again. A lot of people do not get it that is with patient it's like patient was the one who has everything. So, patient was calling and letting company know that she was having the side effects to it, patient don't think she would but here she was with it.The outcome of the events was unknown. Information about Lot/batch no has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/01/2020,,PVT,,,"Medical History/Concurrent Conditions: COVID-19 (I have had Covid before very, very, very, very, very bad)",,,"['Body temperature', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 920006,CA,,U,"moderate myalgias; arthralgias; headaches; rhinorrhea; chest tightness; scratchy throat; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the 1st dose of the Pfizer COVID19 vaccine this week. In Dec2020, patient had 3 days of moderate myalgias, arthralgias, and headaches. Patient also experienced rhinorrhea, chest tightness, and scratchy throat (Dec2020), which were reportedly not effects associated with the vaccine. Patient did get a post vaccination COVID test (PCR) in Dec2020 because of these symptoms, which was negative. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, a contributory role of vaccination with BNT162B2 in the development of the reported events cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Arthralgia', 'Chest discomfort', 'Headache', 'Myalgia', 'Rhinorrhoea', 'SARS-CoV-2 test', 'Throat irritation']",1,PFIZER\BIONTECH, 920007,NY,26.0,F,"headache; fever; severe swelling in her lips; This is a spontaneous report from a contactable other healthcare professional. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration from 23Dec2020 16:30 at single dose for COVID-19 immunization. The patient's medical history included Crohn's disease. Concomitant medications included paroxetine hydrochloride (PAXIL) and spironolactone. The patient previously took morphine and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient was injected with hyaluronic acid lip filler 10 days prior to her vaccine. The patient developed severe swelling in her lips a few hours after she received the vaccine on 23Dec2020. The following day after her vaccine she developed headache and fever too (24Dec2020). The patient went to the Emergency room/department or urgent care and was treated with Benadryl. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,PAXIL [PAROXETINE HYDROCHLORIDE];,,Medical History/Concurrent Conditions: Crohn's,,,"['Headache', 'Lip swelling', 'Pyrexia']",1,PFIZER\BIONTECH, 920008,WV,26.0,F,"nausea; vomiting; This is a spontaneous report from a non-contactable nurse. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: Ek9231, intramuscular on Left arm from 24Dec2020 13:45 to 24Dec2020 13:45 as single dose for COVID-19 immunization. Medical history included depression, anxiety, chronic migraine. Concomitant medication included duloxetine hydrochloride (CYMBALTA), ibuprofen, topiramate (TOPAMAX), bupropion hydrochloride (WELLBUTRIN). On 5Dec2020 05:45, the patient experienced nausea and associated vomiting approximately 16 hours after vaccination administration. The outcome of the events was recovered. No follow-up attempts are possible, information about batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,WRK,CYMBALTA; ; TOPAMAX; WELLBUTRIN,,Medical History/Concurrent Conditions: Anxiety; Chronic migraine; Depression,,,"['Nausea', 'Vomiting']",1,PFIZER\BIONTECH,OT 920009,KY,37.0,F,"Have had headache/migraine 6-24 hours after vaccine; intermittent severe stomach cramping; nausea; severe diarrhea; vomiting; This is a spontaneous report from a contactable nurse (patient). A 37-years-old female patient, non-pregnant, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, in hospital, via an unspecified route of administration on 23Dec2020 at 10:30, at 37-years of age, at single dose in right arm for COVID-19 immunization. Medical history included anxiety, depression and migraines, all from an unknown dates. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), topiramate (TOPAMAX), buspirone hydrochloride (BUSPAR), ibuprofen and levocabastine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache/migraine 6-24 hours after vaccine (onset reported also as 25Dec2020 at 12:00 - to be clarified) and, on 25Dec2020 at 12:00, also reported as 24-72 hours after vaccine, she experienced intermittent severe stomach cramping, nausea, severe diarrhea and vomiting. The patient didn't receive any treatment for the events. The outcome of the events was unknown at the time of the report. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/25/2020,2.0,PVT,EFFEXOR; TOPAMAX; BUSPAR; ; ZYRTEC [LEVOCABASTINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Anxiety; Depression; Migraine,,,"['Abdominal pain upper', 'Diarrhoea', 'Migraine', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH, 920010,IN,,F,"Severe nausea and lightheadedness; Severe nausea and lightheadedness; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received both 1st and 2nd doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), both via unspecified routes of administration at the right arm on unspecified dates at single doses for immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. There were no concomitant medications. On an unspecified date, the patient experienced severe nausea and lightheadedness. There was no treatment given for the events. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (Nasal swab) on an unspecified date and result was negative. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,PVT,,,,,,"['Dizziness', 'Nausea', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 920011,TX,56.0,F,"Aching all over; headaches; shingles; This is a spontaneous report from a contactable Nurse (Patient). A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) via an unspecified route of administration at right arm on 17Dec2020 13:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Relevant medical history and concurrent conditions was reported as ""Structured information (Patient episode name): Fibromyalgia, tachycardia, shingles, breast cancer"". Patient was diagnosed with COVID prior to vaccination. Patient known allergies included Codeine, morphine sulfate (Duramorph) and Sulfa. Concomitant medication included metoprolol succinate (TOPROL), alprazolam (XANAX) and desvenlafaxine succinate (PRISTIQ) received within 2 weeks of vaccination. No other vaccine in four weeks. Adverse events were reported as ""Started day after shot. Aching all over headaches. Broke out in shingles 7 days later"". Adverse event start date was reported on 24Dec2020. No treatment received for the events. since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/24/2020,7.0,PVT,TOPROL; XANAX; PRISTIQ,,"Medical History/Concurrent Conditions: Breast cancer; COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?:Yes); Fibromyalgia; Shingles; Sulfonamide allergy (Allergies to medications, food, or other products: Codeine. Duramorph, Sulfa); Tachycardia",,,"['Headache', 'Herpes zoster', 'Pain']",1,PFIZER\BIONTECH, 920012,,55.0,F,"Rapid heart beat- 2 brief instances within 15-20 minutes of vaccine administration; Light headed feeling; This is a spontaneous report from a non-contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on left arm on 23Dec2020 07:30 at single dose for COVID-19 immunization. Medical history included high blood pressure (HBP), supraventricular tachycardia (h/o SVT), h/o breast cancer, and sulfa drugs allergies. The patient was not pregnant. Concomitant medication included famotidine, metoprolol succinate, and tamoxifen. The patient experienced lightheaded feeling and rapid heartbeat- 2 brief instances within 15-20 minutes of vaccine administration on 23Dec2020. No treatment was received for the events. Facility where the most recent COVID-19 vaccine was administered was at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 since the vaccination via nasal swab on 24Dec2020, results was pending. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,; ;,,Medical History/Concurrent Conditions: Blood pressure high; Breast cancer; Sulfonamide allergy; Supraventricular tachycardia,,,"['Dizziness', 'Heart rate', 'Heart rate increased', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 920013,TX,50.0,F,"diaphoretic; woozy; heart rate went down to 43; blood pressure down to 83/57; headache; feeling a bit cruddy; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: paa156051), via an unspecified route of administration (arm left, dose number 1) on 17Dec2020 10:30 at single dose for COVID-19 immunisation. Medical history included Psoriatic arthritis from an unknown date and unknown if ongoing. Concomitant medication included etanercept (ENBREL), propranolol, and curcuma longa (TURMERIC CURCUMIN). Patient is on unspecified birth control and unspecified vitamins. No other vaccines in four weeks were given. The patient previously took steroids and experienced allergies (similar reaction to steroid 1 year before), and FLONASE and experienced allergies. On 17Dec2020, It was reported that the patient was fine for the first 15 minutes, afterwards became very diaphoretic, woozy, heart rate went down to 43 and blood pressure down to 83/57. The patient recovered enough to leave about 20 minutes. After that, patient's heart rate was back into the 60's and BP stayed the same but the patient was feeling better. Patient's heart rate is usually in the 70's and his BP around 115/75 or so. The patient has no breathing problems. Other than headache and feeling a bit cruddy, the patient has been fine since. Patient mentioned she really wanted to take the second dose, but she does not know if she should. No treatment for the adverse events. No COVID prior vaccination and patient has not tested for COVID post vaccination. Event outcome was recovered on Dec2020. Events were considered non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,ENBREL; ; TURMERIC CURCUMIN [CURCUMA LONGA],,Medical History/Concurrent Conditions: Psoriatic arthritis,,,"['Blood pressure decreased', 'Blood pressure measurement', 'Dizziness', 'Feeling abnormal', 'Headache', 'Heart rate', 'Heart rate decreased', 'Hyperhidrosis']",1,PFIZER\BIONTECH, 920014,,21.0,F,"Swollen lymph node on left side of mouth; This is a spontaneous report from a non-contactable healthcare professional. A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on the right arm on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced swollen lymph node on left side of mouth on an unspecified date. No treatment was given for the event. The outcome of the event was recovering. No follow up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Lymphadenopathy'],1,PFIZER\BIONTECH,OT 920015,,,F,"Caller stated that she received covid vaccine on Tuesday and was tested positive on Friday.; Caller stated that she received covid vaccine on Tuesday and was tested positive on Friday.; This is a spontaneous report from a contactable nurse reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiration date not reported), via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she received the vaccine on Tuesday (Dec2020) and was tested positive on Friday (Dec2020). The patient stated she was told that vaccine was contraindicated in people who have COVID-19. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 920016,IN,44.0,F,"Pain at injection site; Chills; Fever; Fatigue; Headache; This is a spontaneous report from a contactable nurse (patient herself). This 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unspecified route, on 26Dec2020 (at 02:30 PM) at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was not pregnant. Relevant medical history included depression, endometriosis, and COVID-19 in Aug2020. The patient did not have relevant concomitant medications. No other vaccine was received in four weeks. No known allergies. No congenital anomaly/birth defect. The patient was vaccinated at hospital, age at vaccination was 44-year-old. On 27Dec2020 (at 02:00 AM) the patient woke up with chills, fever, fatigue, headache and fever 99.5. After taking 2 paracetamol (TYLENOL) (1.5hr after med temp was taken), she felt like it did when she had COVID in Aug2020. She also had pain at injection site as well (onset date not provided). Post-vaccination COVID test was not performed. Therapeutic measures were taken for fever, no treatments were given for chills, fatigue and headache. The patient had not recovered from fever, chills, fatigue and headache while the outcome from pain at injection site was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/27/2020,1.0,PVT,,,Medical History/Concurrent Conditions: COVID-19; Depression; Endometriosis,,,"['Body temperature', 'Chills', 'Fatigue', 'Headache', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 920017,,,U,"Fever chills; This is a spontaneous report from a contactable Nurse (patient) A patient (demographics unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient stated, 'I received the vaccine without knowing I had COVID 19'. After vaccination, she developed the symptoms fever chills. She performed swab and was positive. Information on the Lot/Batch Number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Pyrexia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 920018,RI,,F,"hypersensitivity reaction to COVID-19 Vaccine; throat pain that progressed to a little bit of tightness; ear pain; wheals develop on her back bilaterally; This is a spontaneous report from a contactable pharmacist. A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685 and Expiry date: 31Mar2021, strength: 0.3ml) (NDC number: 59267-1000-2) via Intramuscular on 21Dec2020 12:21PM at 0.3ml single dose for COVID-19 immunization. The patient's medical history and concomitant drug was reported as none. The patient experienced a hypersensitivity reaction to COVID-19 Vaccine late last night on 21Dec2020. Hypersensitivity reaction: Further described as patient developed throat pain that progressed to a little bit of tightness; some ear pain; and had wheals develop on her back bilaterally. She was transported to the emergency room on 21Dec2020 where she received treatment and was under observation. The outcome of events was unknown. Since whether outcome recovered completely, recovered with lasting effects or just improved is unknown. She was not admitted to the hospital; she was sent home from the emergency room after 2.5 hours. Caller reported seriousness criteria as medically significant because event required medical intervention. Causality was very likely. Patient at time of this report is scheduled to receive the second dose of vaccine; they have not determined if she will receive the second scheduled dose or change/stop dose in response to this event. First dose; scheduled to receive a second dose; have not determined if will be continuing with it.; Sender's Comments: Based on the compatible time association, the hypersensitivity reactions are reasonably related to suspect BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/21/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Ear pain', 'Hypersensitivity', 'Oropharyngeal pain', 'Throat tightness', 'Urticaria']",1,PFIZER\BIONTECH,OT 920019,TN,65.0,F,"On day 8 arm again was sore and now itchy with reddened area larger than injection site 3x4 inches.; On day 8 arm again was sore and now itchy with reddened area larger than injection site 3x4 inches.; Reported soreness at injection site and some soreness which was gone by day 5 or 6. On day 8 arm again was sore and now itchy with reddened area larger than injection site 3x4 inches.; Reported soreness at injection site and some soreness which was gone by day 5 or 6; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on left arm on 17Dec2020 15:30 at single dose for COVID-19 immunization. Medical history included hypothyroid, osteoporosis, and known allergies to sulfa and tetracycline. The patient was not pregnant. The patient reported soreness at injection site and some soreness on Dec2020 which was gone by day 5 or 6. On day 8 (25Dec2020) arm again was sore and now itchy with reddened area larger than injection site 3x4 inches. No treatment was given for the events. The COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but received unspecified medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the event pain was recovered and not recovered for the rest of the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/01/2020,,PVT,,,Medical History/Concurrent Conditions: Hypothyroidism; Osteoporosis; Sulfonamide allergy,,,"['Pain', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site pruritus']",1,PFIZER\BIONTECH, 920020,CA,37.0,F,It still hurts to abduct my left arm; This is a spontaneous report from a contactable Physician (patient). A 37-year-old female patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 at single dose in left arm for COVID-19 immunisation at the age of 37-year-old. Lot number was EJ1685. Medical history was unknown and concomitant medications were unknown. Patient was not pregnant at the time of vaccination. It was reported that since 19dec2020 it did still hurt to abduct left arm.. The patient was not treated for the event. The patient did not recover from the event.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/19/2020,0.0,PVT,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 920021,PA,30.0,F,"Sore throat; not feeling well/general malaise; feeling tired/fatigue; Feeling achy; This is a spontaneous report from a contactable physician (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 11:00 single dose for preventive. Medical history included depression. Concomitant medication included duloxetine hydrochloride (CYMBALTA) for depression. The patient previously took flu vaccine for immunization. The patient received the Covid 19 vaccine on Wednesday. Patient stated there was a possibility of feeling achy just a general possibility of not feeling well like feeling tired, like it was she had that flu, vaccine too. But, her symptoms had persisted and she also had an isolated sore throat that started after she got her vaccine. She understood that the vaccine did not cause Covid but she was not sure like if having a sore throat was what other people have reported or this was something where she should go and get tested. Physician stated that question hadn't been answered by the previous department. When probed if the indication was a preventive measure for Covid, Physician stated ""Preventive."" Event (sore throat) started on 23Dec2020. The patient was given the vaccine at 11 am and her symptoms started probably at around 21:00 (9 pm). Patient further stated she received vaccine on 23Dec2020 around 11am and developed side effects of sore throat, fatigue/general malaise that evening. She couldn't find any data specifically reporting on sore throat. She was wondering if she should get tested for covid. Investigation assessment was no. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,UNK,CYMBALTA,,Medical History/Concurrent Conditions: Depression,,,"['Fatigue', 'Malaise', 'Oropharyngeal pain', 'Pain']",1,PFIZER\BIONTECH, 920022,IL,24.0,F,"Rash on face, neck, arms and hands.; This is a spontaneous report from a contactable other hcp (patient). A 24-year-old non-pregnant female patient first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EJ1685), via an unspecified route of administration on 21Dec2020 19:00 at Left arm at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included eczema. No known allergies. Concomitant medication included levonorgestrel (NORTREL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Rash on face, neck, arms and hands on 21Dec2020 22:00. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,PVT,NORTREL,,Medical History/Concurrent Conditions: Eczema,,,['Rash'],1,PFIZER\BIONTECH, 920023,NY,26.0,F,"mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; This is a spontaneous report from a contactable healthcare professional. A 26-year-old female patient started received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), intramuscular on the left arm on 23Dec2020 09:45 at a single dose for COVID-19 immunisation. Medical history included autoimmune thyroiditis. Concomitant medication included levothyroxine sodium (SYNTHROID). On 23Dec2020 at 11:00, the patient experienced mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with ibuprofen. Clinical outcome of the events was recovered on an unspecified date in Dec2020. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,SYNTHROID,,Medical History/Concurrent Conditions: Hashimoto's thyroiditis,,,"['Headache', 'Pain in extremity']",1,PFIZER\BIONTECH,OT 920024,MI,60.0,F,"Blurred vision that was mild in nature (but noticeable, nonetheless). Began 15 minutes after vaccine received. Lasted 10 minutes. Resolved on its own. NOT accompanied by any other effect (i.e. nausea, vertigo, lightheadedness); This is a spontaneous report from a contactable nurse. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL0140), via an unspecified route of administration on the right arm on 23Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) on an unspecified date and Ductal carcinoma in situ (DCIS) on the left breast in 2008. Concomitant medications included omeprazole and cetirizine (CETIRIZINE). On 23Dec2020 at 10:30, the patient had a blurred vision that was mild in nature (but noticeable, nonetheless). It began 15 minutes after vaccine received and lasted for 10 minutes. It resolved on its own and not accompanied by any other effect (i.e. nausea, vertigo, lightheadedness). No therapeutic measure was taken as a result of the event. Clinical outcome of the event was recovered on 23Dec2020 at 10:40. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,;,,Medical History/Concurrent Conditions: Ductal carcinoma in situ; GERD,,,['Vision blurred'],UNK,PFIZER\BIONTECH, 920025,IN,38.0,F,"tongue started to get a little bit of numbness and tingling/the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue; tongue started to get a little bit of numbness and tingling/the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue; numbness and tingling progressed up my cheeks and up underneath my eyes on both sides; numbness and tingling progressed up my cheeks and up underneath my eyes on both sides; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 26Dec2020 11:30 AM at single dose for covid-19 immunization. The COVID-19 vaccine was given at nurse's hospital vaccine clinic. Medical history included narcolepsy with cataplexy. Concomitant medication in two weeks included venlafaxine hydrochloride (EFFEXOR SR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took naproxen and erythromycin; and experienced drug allergy. On 26Dec2020, the patient stated ""At about 1150 my tongue started to get a little bit of numbness and tingling. I didn't really feel nervous but I thought maybe some type of anxious reaction. So I thought I'd give it just a little time and over the next 20 minutes the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue, up my cheeks and up underneath my eyes on both sides. I was not feeling anxious about the vaccination. I didn't have any trouble breathing or difficulty swallowing. It felt like Novocain that was wearing off like after you have dental work done. I decided to take 25mg Benadryl to see if it went away. And it definitely got better about 25 minutes after I took the Benadryl. Within an hour I would say it was 95% gone. Still just like a trace numbness on my cheeks. When I woke up this morning (27Dec2020) I noticed the facial numbness had completely resolved."" The adverse event start time also reported as 11:45 AM. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 27Dec2020. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,OTH,EFFEXOR SR; ADDERALL,,Medical History/Concurrent Conditions: Cataplexy; Narcolepsy,,,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,OT 920026,TX,39.0,M,"experienced swelling of the face and eyes on 24Dec2020. The swelling has progressed since 24Dec2020.; experienced swelling of the face and eyes on 24Dec2020. The swelling has progressed since 24Dec2020.; This is a spontaneous report from a contactable nurse. A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration on the left arm at a single dose on 21Dec2020 14:30 for COVID-19 immunization. Medical history was not reported. Concomitant medications included multivitamins (unspecified). The patient experienced swelling of the face and eyes on 24Dec2020 at 22:00. The swelling has progressed since 24Dec2020. No therapeutic measure was taken as a result of the event. Clinical outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/24/2020,3.0,PVT,,,,,,"['Eye swelling', 'Swelling face']",1,PFIZER\BIONTECH, 920027,MO,53.0,F,"it made me turned flushed, really almost purple/ My face was red, arms were red, my neck was red; Sweating; The initial case was missing the following minimum criteria: adverse event nos. Upon receipt of follow-up information on (27Dec2020), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EH9899, expiry date not reported), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medications included metoprolol, hydrochlorothiazide, and lisinopril; all from unspecified dates for blood pressure high. The patient verbalized, ""I had the vaccine on last Monday be 21st. I had an issue and ended up in the ER. It made me turned flushed, really almost purple, no anaphylactic nothing, just sweating, my face was red, arms were red, my neck was red but that is it. They gave me Pepcid and Benadryl in ER and watched me in the ER for about 40 minutes. I work at the hospital and I got it from them. I was fine the rest of the week, Thursday, my son came by to pick up a couple of holiday gifts only saw him for 5 minutes. He has now tested positive for COVID. We had masks on. I hugged him on his way out. He took the gifts and left. He is at home now. He got tested yesterday positive for COVID. My question is am I still at risk of getting it from that meeting after I only had one shot?"" On an unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement: 133/85 and body temperature: 97.9. Therapeutic measures were taken as a result of the events that included Pepcid and Benadryl. Clinical outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/21/2020,0.0,UNK,; ;,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Blood pressure measurement', 'Body temperature', 'Flushing', 'Hyperhidrosis']",UNK,PFIZER\BIONTECH, 920028,FL,65.0,M,"Paresthesias in a trigeminal nerve distribution starting 3 days after vaccination; Paresthesias in a trigeminal nerve distribution starting 3 days after vaccination; This is a spontaneous report from a contactable physician. A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EH9899), via an unspecified route of administration on the left arm on 18Dec2020 15:45 at single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications were not reported. The patient experienced paraesthesias in a trigeminal nerve distribution starting 3 days after vaccination on 21Dec2020 18:30. The patient underwent lab tests and procedures which included Nasal Swab/Antigen rapid: negative on 25Dec2020. Therapeutic measures were taken as a result of the event that included Medrol dose pack and famvir. Symptomology was mild, 80% improved one week later. Clinical outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/21/2020,3.0,PVT,,,Medical History/Concurrent Conditions: Hypothyroidism,,,"['Paraesthesia', 'SARS-CoV-2 test', 'Trigeminal nerve disorder']",UNK,PFIZER\BIONTECH, 920029,CA,42.0,F,"flushed; noticed some hives on forehead and forearm; This is a spontaneous report from a non-contactable nurse. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK5730), intramuscular on the left arm on 18Dec2020 09:30 at single dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications were not reported. The patient previously took NSAIDS and experienced allergies. The patient flushed and noticed some hives on forehead and forearm on 18Dec2020 10:15. Therapeutic measure was taken as a result of the events that included Benadryl. Clinical outcome of flushing was not recovered while for hives recovered on Dec2020. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Shellfish allergy,,,"['Flushing', 'Urticaria']",1,PFIZER\BIONTECH,OT 920030,VT,41.0,F,"Severe fatigue; chills; headache; sore throat; muscle aches; This is a spontaneous report from a contactable Other HCP (patient). A 41-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number not provided), via an unspecified route of administration in left arm on 23Dec2020 16:45 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced severe fatigue, chills, headache, sore throat, muscle aches on 24Dec2020. Case was non-serious. The patient underwent lab tests and procedures which included covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test date=26Dec2020, covid test result=Negative. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,,,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Oropharyngeal pain', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 920031,NM,31.0,F,"light headed; soreness to site of injection; felt a random itch run along from my hand to up along my arm; some warmth to the site; This is a spontaneous report from a contactable other HCP (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer), intramuscularly on 23Dec2020 07:30AM at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Medical history included depression from an unknown date. No allergies to medications, food, or other products. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. Concomitant medication included fluoxetine. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. At the day of 23Dec2020 at 7:30 am the time of injection patient felt okay. She was let go to go back straight in to work. Once at work she felt light headed for 30 minutes with soreness to site of injection. Patient also felt a random itch run along from her hand to up along her arm. She applied lotion to the site if irritation for some comfort. The next 2 days patient still felt soreness and some warmth to the site. It's unknown if patient received treatment for the other adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The date report was first received from source was 27Dec2020. The events were reported as non-serious. No follow up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Depression,,,"['Dizziness', 'Pruritus', 'Vaccination site pain', 'Vaccination site warmth']",1,PFIZER\BIONTECH,OT 920032,TN,46.0,F,"Fine rash developed on arms and legs; Red, itchy patches on abdomen, back, neck and chin; Hot, burning sensation to palms of hands and soles of feet; Red, itchy patches on abdomen, back, neck and chin; Hot, burning sensation to palms of hands and soles of feet; This is a spontaneous report from a contactable nurse, the patient. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EJ1685), via an unspecified route of administration on 25Dec2020 at 03:00 PM (at the age of 46-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. Medical history included anemia. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took sulfa (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced allergy. On 25Dec2020 at 08:00PM, a fine rash developed on arms and legs. Red, itchy patches on abdomen, back, neck and chin. Hot, burning sensation to palms of hands and soles of feet. The patient did not receive any treatment for the events. The clinical outcome of the events rash on legs & arms, Red, itchy patches on abdomen, back, neck and chin, and Hot, burning sensation to palms of hands and soles of feet was recovered on an unspecified date in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. There were no other vaccines the patient received within 4 weeks of the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/25/2020,12/25/2020,0.0,PVT,NUVARING;,,Medical History/Concurrent Conditions: Anemia; Sulfonamide allergy,,,"['Burning sensation', 'Pain in extremity', 'Rash', 'Rash erythematous', 'Rash pruritic']",1,PFIZER\BIONTECH, 920033,,,F,"rash on the face; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash on the face on 25Dec2020 in the afternoon, it was not bad, but it always happen in the afternoon. The outcome of the event was unknown. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/25/2020,2.0,UNK,,,,,,['Rash'],UNK,PFIZER\BIONTECH, 920034,CA,32.0,F,"Tachycardia (over 100 bpm for 48hr); Nausea; Headache; Chills; arm pain; This is a spontaneous report from a contactable Nurse reporting for herself. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left arm on 18Dec2020 13:00 at single dose for covid-19 immunization. It was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included Reynald's, Irritable bowel syndrome (IBS), spontaneous pneumothorax. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had allergy to medication of Vicodin. The patient experienced tachycardia (over 100 bpm for 48hr), nausea, headache, chills, arm pain, started on 18Dec2020 13:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event Tachycardia was recovered on 20Dec2020 13:00, the outcome of the other event was recovered on an unknown date in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Irritable bowel syndrome; Pneumothorax spontaneous; Reynold's syndrome,,,"['Chills', 'Headache', 'Heart rate', 'Nausea', 'Pain in extremity', 'Tachycardia']",1,PFIZER\BIONTECH,OT 920035,MA,57.0,F,"cough; change in taste and smell; change in taste and smell; injection site pain; feverish but afebrile; chills; intense headache; nasal congestion; malaise; This is a spontaneous report from a contactable nurse (patient herself). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EKS730, expiration date: unknown), via an unspecified route of administration on the left arm on 18Dec2020 at 13:00 at a single dose for COVID-19 immunization administered at the workplace clinic. Relevant medical history included hypertension (HTN), hypothyroidism, high cholesterol, and COVID-19 prior to vaccination. The patient had no known allergies. Concomitant medications included levothyroxine, amlodipine, and pravastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient experienced feverish but afebrile, chills, intense headache, nasal congestion, malaise, cough, change in taste and smell, and injection site pain on 19Dec2020 at 12:00. The events were assessed as non-serious. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered with sequelae/lasting effects from the events ""feverish but afebrile, chills, intense headache, nasal congestion, malaise, cough, change in taste and smell, and injection site pain"" on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/19/2020,1.0,WRK,; ;,,Medical History/Concurrent Conditions: COVID-19; High cholesterol; Hypertension; Hypothyroidism,,,"['Chills', 'Cough', 'Headache', 'Malaise', 'Nasal congestion', 'Parosmia', 'Pyrexia', 'Taste disorder', 'Vaccination site pain']",1,PFIZER\BIONTECH, 920036,IL,69.0,F,"slightly painful enlarged left axillary node that is on ipsilateral side of injection; slightly painful enlarged left axillary node that is on ipsilateral side of injection; paraspinal muscle pain resolved by next day; In evening had mild pain site injection gone in a day; This is a spontaneous report from a contactable physician (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EK5730), intramuscular on the left arm on 20Dec2020 12:00 at SINGLE DOSE as COVID-19 immunization at the hospital. Medical history included Graves disease. The patient also had allergies with penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID), acetylsalicylic acid (BABY ASPIRIN), and colecalciferol (VITAMIN D). It was mentioned that prior to vaccination, the patient diagnosed was not with COVID-19 and had not been tested for COVID-19 since vaccination. On 21Dec2020 in evening, the patient had mild pain site injection gone in a day (22Dec2020). On 22Dec2020 (day after injection), the patient then had paraspinal muscle pain resolved by next day (23Dec2020). The patient took ibuprofen (MOTRIN) in evening and gone by morning. Day 7 (28Dec2020), the patient noticed slightly painful enlarged left axillary node that was on ipsilateral side of injection which was still present (no treatment was received for the events). The patient recovered from the event of mild pain site injection on 22Dec2020 and paraspinal muscle pain on 23Dec2020 while not recovered for the remaining events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/21/2020,1.0,PVT,SYNTHROID; BABY ASPIRIN; VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: Graves' disease; Penicillin allergy,,,"['Lymph node pain', 'Lymphadenopathy', 'Myalgia', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 920037,CA,,F,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable nurse, who is also the patient. This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The reporting nurse stated that she received her first dose of the COVID-19 vaccine on Saturday (e.g. Dec2020). She had taken a PCR test on Thursday and received a negative result on Saturday, the same day she received her vaccination. She reported developing a fever on Monday night and testing positive for COVID-19 on Tuesday. At the time of the report, the outcome of the events was unknown. The information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded. More information such as laboratory findings on viral nucleic acid /PCR test needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 920038,CA,45.0,F,"Onset dizziness when turning to the left or going from laying to sitting / standing. Does not occur sitting to standing; Onset dizziness when turning to the left or going from laying to sitting / standing. Does not occur sitting to standing; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on the left arm on 26Dec2020 10:00 at SINGLE DOSE as COVID-19 immunization at the hospital. Medical history included psoriasis. Concomitant medications included adalimumab (HUMIRA) and famotidine (FAMOTIDINE). It was mentioned that prior to vaccination, the patient diagnosed was not with COVID-19 and had not been tested for COVID-19 since vaccination. On 26Dec2020 17:00, the patient experienced onset dizziness when turning to the left or going from laying to sitting / standing but does not occur sitting to standing. The patient did not receive any treatment for the events. Outcome of the events were not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/26/2020,0.0,PVT,HUMIRA;,,Medical History/Concurrent Conditions: Psoriasis,,,"['Dizziness', 'Dizziness postural']",1,PFIZER\BIONTECH, 920039,WI,55.0,F,"fatigue; Fever/Woke up on 27Dec2020 with 100.5F; some soreness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK5730), intramuscular on the right arm on 26Dec2020 10:45 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included hypertension. Concomitant medications included lisinopril (LISINOPRIL), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), citalopram (CITALOPRAM), ascorbic acid (VITAMIN C), calcium (CALCIUM), loratadine (LORATADINE) and Sudaphrene pene (as reported). It was mentioned that prior to vaccination, the patient diagnosed was not with COVID-19 and had not been tested for COVID-19 since vaccination. On 26Dec2020 06:00 (as reported), the patient had fatigue, and some soreness at injection site. It was reported that the patient woke up on 27Dec2020 with 100.5 F that lasted most of day until 5 pm. It was mentioned that the patient did not receive any treatment for the events. The patient recovered from fever on 27Dec2020 17:00 while recovering for the remaining events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/26/2020,0.0,PVT,; ; ; VITAMIN C [ASCORBIC ACID]; ;,,Medical History/Concurrent Conditions: Hypertension,,,"['Body temperature', 'Fatigue', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 920040,SC,53.0,F,"fever; Diarrhea; headache; chills; feeling unwell; Joint pain; injection site pain; tiredness; This is a spontaneous report from a contactable consumer. A 53-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EK5730), intramuscular (Dose number 1, Arm left) on 23Dec2020, 13:45 at single dose for COVID-19 immunization. Medical history included diabetic, thyroidectomy, hysterectomy, tonsillectomy, and Known allergies: Sulfa. Concomitant medication included zolpidem, levothyroxine, and pantoprazole from unspecified dates for an unspecified indication. The patient experienced fever, diarrhea, headache, chills, feeling unwell, joint pain, injection site pain, and tiredness on 23Dec2020 13:45. No treatment for AE was given. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 since vaccination. Outcome of the events was not recovered. Events were reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,; ;,,Medical History/Concurrent Conditions: Diabetic; Hysterectomy; Sulfonamide allergy (Known allergies: Sulfa); Thyroidectomy; Tonsillectomy,,,"['Arthralgia', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Malaise', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 920041,,,F,"coughing; fatigue; body aches; This is a spontaneous report from a contactable healthcare professional (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 10:30 at a single dose for COVID-19 immunization. The patient's medical history was unknown. Concomitant medication included paracetamol (TYLENOL). The patient experienced having side effects that started on the night of 25Dec2020 including coughing, fatigue, and body aches. She received a Fact Sheet for Recipients and Caregivers as well as instructions on how to report her symptoms to VAERS. She has not reported her symptoms to anyone yet. She stated her facility has antigen testing every day that results in 15 minutes and a COVID test every Monday with results in three days. She has been negative for her testing for 12 weeks and has not received any positive test results to date. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/25/2020,3.0,UNK,TYLENOL,,,,,"['Cough', 'Fatigue', 'Pain', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 920042,WA,,F,"Sore injection site, hot flashes with no fever, styes on both eyes; Sore injection site, hot flashes with no fever, styes on both eyes; Sore injection site, hot flashes with no fever, styes on both eyes; This is a spontaneous report from a contactable nurse (patient). An adult female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on the left arm on 26Dec2020 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included suspected endometriosis. It was also reported that the patient had allergies to ranitidine (ZANTAC), omeprazole (PRILOSEC), famotidine (PEPCID), kiwi, and adhesive. Concomitant medications included sertraline hydrochloride (ZOLOFT), fish oil (FISH OIL), and colecalciferol (VITAMIN D). It was mentioned that prior to vaccination, the patient diagnosed was not with COVID-19 and had not been tested for COVID-19 since vaccination. On 27Dec2020 07:00, the patient experienced sore injection site, hot flashes with no fever, and styes on both eyes. The patient did not receive any treatment for the events. Outcome of the events were unknown. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/27/2020,1.0,PVT,ZOLOFT; ; VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: Adhesive tape allergy; Endometriosis; Fruit allergy,,,"['Hordeolum', 'Hot flush', 'Vaccination site pain']",1,PFIZER\BIONTECH, 920043,NC,29.0,F,"All of a sudden I did not have any taste or smell; All of a sudden I did not have any taste or smell; Tested positive; Tested positive; This is a spontaneous report from a contactable nurse reported for herself. A 29-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, batch/lot EH9899), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. Medical history included seasonal allergy. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient was taking a multivitamin a day. The patient experienced typical symptoms no taste, smell on 22Dec2020, Slight tingling, body aches, chills, all the other symptoms for Covid and now positive for Covid in Dec2020. Outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for Covid based on the known safety profile.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/01/2020,,PVT,ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Seasonal allergy,,,"['Ageusia', 'Anosmia', 'Chills', 'Pain', 'Paraesthesia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 920044,TX,36.0,F,"Left Red eye; Sore right arm; This is a spontaneous report from a contactable nurse. This 36-year-old female nurse reported for herself that a 36-years-old female patient started to receive bnt162b2 (BNT162B2; Brand: Pfizer; Dose number: 1), intramuscular on 24Dec2020 15:45 at SINGLE DOSE at Vaccine location of Right arm for covid-19 immunisation. Patient was not Pregnant at the time of vaccination. Medical history included Graves disease. Patient had none Known allergies. The patient had no Allergies to medications, food, or other products. Concomitant medication included spironolactone (ALDACTONE), methimazole (METHIMAZOLE) within 2 weeks of vaccination. The patient experienced left red eye and sore right arm, both on 25Dec2020 with outcome of not recovered. No treatment received. The events reported as non-serious. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient hasn't been tested for COVID-19. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,PVT,ALDACTONE [SPIRONOLACTONE]; METHIMAZOLE,,Medical History/Concurrent Conditions: Graves' disease (Graves disease),,,"['Ocular hyperaemia', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 920045,,33.0,F,"Left axillary lymphadenopathy; This is a spontaneous report from a non-contactable physician. A 33-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 21Dec2020 at single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Dec2020, the patient experienced left axillary lymphadenopathy. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. The case was assessed as non-serious. The outcome of the event was unknown. No follow-up attempts are possible. Information about batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/26/2020,5.0,UNK,,,,,,['Lymphadenopathy'],1,PFIZER\BIONTECH, 920046,NJ,29.0,F,"feeling flushed; facial swelling; This is a spontaneous report from a contactable physician reported for self. This 29-year-old female (No pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm on 23Dec2020 14:30 at single dose for COVID-19 immunization. No COVID prior vaccination, No COVID tested post vaccination. No known allergies or other medical history. No other vaccine in four weeks, No other medications in two weeks. The patient got the vaccine Wednesday afternoon (on 23Dec2020 14:30), then Thursday evening (>24h, 24Dec2020 07:45 PM) started feeling flushed and had facial swelling after dinner. No other symptoms. Resolved with Benadryl. Then again Saturday morning while brushing teeth and Saturday evening after dinner. One more time Sunday morning during breakfast. Each time the symptoms were milder than before. Took Benadryl as needed. No new foods, meds etc. The outcome of event was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Flushing', 'Swelling face']",1,PFIZER\BIONTECH, 920047,IL,37.0,F,"I got the Covid Vaccine and Wondering I have been having increasingly shortness of breath for last few days; gotten worse everyday its a little bit worse; This is a spontaneous report from a contactable nurse. This nurse reported for self that the 37-year-old female patient received first dose of bnt162b2 (BNT162B2, lot: EJ1685, Expiration Date: Mar2021), via Intramuscular on left deltoid on 20Dec2020 at single dose for covid-19 immunisation. Medical history was none. Concomitant medications included Multivitamins and escitalopram oxalate (LEXAPRO). Nurse stated, ""I was wondering I got the Pfizer (Covid) Vaccine on 20th and I have been having increasingly shortness of breath for last few days and I am wondering if that's the typical side effect of that. It wasn't prescribed, it was something given out to all the healthcare providers. It was like the first dose. It was first dose. I got an Intramuscular shot in left shoulder. Because I wanted to not spread it (Covid). I am not sure if it is due to the product, I got ""6"" (not clarified) from another patient, that's why I am calling, I want to know if this is like the typical side effect of vaccination or should I go get tested. I haven't taken any treatment yet. It's gotten worse everyday its a little bit worse."" The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,,,UNK,LEXAPRO,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Dyspnoea'],1,PFIZER\BIONTECH,OT 920048,MI,55.0,F,"All over my back, my butt, my legs; Itching; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received bnt162b2 (BNT162B2, Lot: EL0140, Exp:Mar2021), via an unspecified route of administration on 21Dec2020 for first dose at single dose for COVID-19 immunisation. Medical history included blood pressure high and anxiety. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]) for Blood pressure high and an anxiety medicine. The patient experienced itching there was nothing on 25Dec2020, in the morning of 26Dec2020, suddenly had rash all over back, butt, leg, she would like have the rash over body and she knew the reaction like the people like said it was within a couple of hours but this was more than couple of hours it is few days. At the time of reporting, no treatment received, she might go emergency to see if I get good dose of Benadryl. The event outcome was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/25/2020,4.0,UNK,LIPITOR [ATORVASTATIN],,Medical History/Concurrent Conditions: Anxiety; Blood pressure high,,,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH, 920049,OH,43.0,M,"Urine is dark red, I mean like dark orange; This is a spontaneous report from a contactable physician (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number and expiration date not reported, via an unspecified route of administration from 22Dec2020 to 22Dec2020 as single dose (into the deltoid) for COVID-19 immunization. Medical history included Hair loss. Concomitant medication included finasteride 2.5 mg, daily for Hair loss. The patient stated, ""So, I got the COVID 19 Vaccine on Tuesday, and I had no fever or anything like that. It was the first shot I got it into the deltoid and today (25De2020), I noticed my urine is dark red, I mean like dark orange. I didn't know if it's a common side effect or not?"" Physician stated, ""I never had it before, it's very unusual. When asked for treatment, physician stated, ""No, I didn't. Just water."". The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/25/2020,3.0,PVT,,,Medical History/Concurrent Conditions: Hair loss,,,['Chromaturia'],UNK,PFIZER\BIONTECH, 920050,IL,30.0,F,"Still having pain in right arm a week after injection; Warmth/redness and hardness of injection site; Warmth/redness and hardness of injection site; Warmth/redness and hardness of injection site; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 19Dec2020 19:15 at single dose on right arm for COVID-19 immunization in hospital. Medical history was reported as none and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced still having pain in right arm a week after injection, warmth/redness and hardness of injection site from 19Dec2020 19:15. No treatment received for the adverse events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. The information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/19/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Pain in extremity', 'Vaccination site erythema', 'Vaccination site induration', 'Vaccination site warmth']",1,PFIZER\BIONTECH, 920051,AZ,39.0,M,"Mild discomfort the day after at the injection site; Nausea; extreme fatigue; Muscle ache/ Muscle pain; Cough; Sore throat; Headache; All of joints were painful; This is a spontaneous report from a contactable physician reported for self. This 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left arm (IM in left shoulder) on 22Dec2020 at single dose for COVID-19 immunization. None medical history nor concomitant medications. Three hours after the vaccine (on 22Dec2020) patient started developing nausea that was pretty much and it was enough that patient had to stay at home instead of going out to shoot golf balls, it was so significant nausea. Then he had some extreme fatigue, muscle ache/muscle pain, started developing cough, sore throat and headache. Then all of his joints were painful. Patient had a mild discomfort the day after at the injection site. The next day (on 23Dec2020) when he woke up nausea was gone. Patient might just have some general labs at the family practitioner just to check cholesterol. The outcome of ""nausea"" was recovered on 23Dec2020, of ""mild discomfort at the injection site"" was unknown, outcome of else events was not recovered. The reporting physician considered all events ""related"" to the Covid 19 Vaccine, Physician stated 100 percent it is from the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Cough', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Vaccination site discomfort']",UNK,PFIZER\BIONTECH,OT 920052,OH,24.0,F,"Dizzy; This is a spontaneous report from contactable consumer (parent). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number and expiration date not reported, via an unspecified route of administration from 22Dec2020 to 22Dec2020 as single dose for COVID-19 immunization. Medical history included asthma and allergy. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for Allergy and budesonide, formoterol fumarate (SYMBICORT) for Asthma. The patient's parent stated that the patient experienced dizzy on 25Dec2020. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/25/2020,3.0,PVT,ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SYMBICORT,,Medical History/Concurrent Conditions: Allergy; Asthma,,,['Dizziness'],UNK,PFIZER\BIONTECH, 920053,,,F,"sore throat; coughing; headache; soreness of injection site; tiredness; This is a spontaneous report from a contactable Other HCP (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 26Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the Covid vaccine yesterday (26Dec2020) and is now experiencing headache, soreness of injection site and tiredness. Additionally, she is also experiencing sore throat and coughing which started today (27Dec2020). The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/01/2020,,UNK,,,,,,"['Cough', 'Fatigue', 'Headache', 'Oropharyngeal pain', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 920054,NM,,M,"The patient's wife felt soreness and some warmth to the site. The patient (husband) felt the warmth as well; This is a spontaneous report from a contactable other health care professional. A male patient of an unspecified age started to receive bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The wife felt soreness and some warmth to the site. The patient (husband) felt the warmth as well. No other symptoms reported. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination site warmth'],UNK,PFIZER\BIONTECH, 920055,CT,55.0,F,"Her arm was very sore; Intermittent stabbing headache; This is a spontaneous report from a non-contactable consumer (patient's Sister). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. On 27Dec2020 patient experienced an ""intermittent stabbing headache"" and her arm was very sore but much better the day of the report. Patient would not take paracetamol (TYLENOL) because she was still very functional. Outcome of the events was unknown. Information about lot/Batch number cannot be obtained. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/27/2020,1.0,UNK,,,,,,"['Headache', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 920056,NC,43.0,F,"No appetite; congested head; congested head, cough; headache; fatigue; nausea; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; This is a spontaneous report from a contactable other health care professional. A 43-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 18Dec2020 11:00 at single dose at arm (pending clarification) for COVID-19 immunization. Medical history included asthma, allergies, depression, penicillin allergy, allergies to: Mangoes, Cashews, Peaches. Concomitant medications included sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient previously took amoxicillin and experienced known allergies: Amoxicillin. On 18Dec2020: about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant. Lasted about an hour. On 19Dec2020: afternoon - headache, nausea, fatigue started. On 20Dec2020: continued to feel fatigued and same symptoms. On 21Dec2020: headache, waves of nausea along with feeling flush (no fever ever) and elevated heart rate. On 22Dec2020: Same. The patient continued to work through all this but felt lousy. On 23Dec2020: stayed home from work because work wanted the patient to take a Covid Test (this was negative) - so laid around. Still with headache and nausea, easily fatigued. Cough started PM. On 24Dec2020: no nausea but continued headache, congested head, cough. On 25Dec2020: feeling better. No appetite. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, and was negative on 23Dec2020. The outcome of the events was recovered. The patient did not receive treatment for the events. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,ZOLOFT; SINGULAIR; ALLEGRA; FLONASE [FLUTICASONE PROPIONATE],,Medical History/Concurrent Conditions: Allergy; Asthma; Depression; Food allergy; Penicillin allergy,,,"['Cough', 'Decreased appetite', 'Fatigue', 'Feeling jittery', 'Flushing', 'Headache', 'Heart rate', 'Heart rate increased', 'Nausea', 'SARS-CoV-2 test', 'Upper respiratory tract congestion']",1,PFIZER\BIONTECH, 920057,VA,51.0,F,"Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clavicular probable lymph node which is large and painful. Possible neck lymphadenopathy as well.; Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clavicular probable lymph node which is large and painful. Possible neck lymphadenopathy as well.; Experienced numbness and tingling in left arm on day 1 which resolved; Experienced numbness and tingling in left arm on day 1 which resolved.; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 10:30 AM at left arm, at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and known allergies to amoxicillin. The patient was not pregnant at the time of vaccination. The patient experienced numbness and tingling in left arm on day 1 (23Dec2020) which resolved in Dec2020. 3 days later noted left clavicular probable lymph node which is large and painful on 25Dec2020 07:00 PM. Possible neck lymphadenopathy as well. No treatment was received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events numbness and tingling in left arm was recovered in Dec2020. The outcome of the other events was not recovered. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,,,,,,"['Hypoaesthesia', 'Lymphadenopathy', 'Nodule', 'Paraesthesia']",1,PFIZER\BIONTECH, 920058,MI,59.0,F,"Itching at injection site; This is a spontaneous report from a contactable Other health care professional (HCP) reporting for herself. A 59-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 23Dec2020 at 06:30 PM at single dose for COVID-19 immunization. Medical history included breast cancer (Currently healthy). Concomitant medications included Tamoxifen and vitamin D. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 25Dec2020 patient experienced Itching at injection site. No treatment was received for the event. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient had not recovered from the event at the time of the report. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/25/2020,2.0,PVT,; VITAMIN D [ERGOCALCIFEROL],,Medical History/Concurrent Conditions: Breast cancer (Currently healthy),,,['Vaccination site pruritus'],1,PFIZER\BIONTECH, 920059,NY,35.0,F,"I am not feeling well; had a Covid PCR done swapped on yesterday and I am Covid positive; had a Covid PCR done swapped on yesterday and I am Covid positive; This is a spontaneous report from a contactable nurse. This nurse reported for herself that the 35-year-old female patient who received bnt162b2 (BNT162B2), via unknown route of administration on 23Dec2020 at single dose for covid-19 immunisation. Medical history was none. Concomitant medications were none. Nurse stated, ""I received the Pfizer Vaccine this Wednesday and right before getting the vaccine, I had a Covid test (captured as per verbatim) on before the vaccine on Tuesday (22Dec2020) was negative. I had a Covid PCR done swapped on yesterday (25Dec2020) and I am Covid positive. So I have the vaccine and I am Covid positive"" Nurse stated ""It's ""140"" ""130"" pounds (further bot clarified)."" The patient was not feeling well. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the SARS-CoV-2 test positive and vaccination with BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/25/2020,2.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Malaise', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 920060,WA,44.0,F,"Fatigue, sleepiness; Fatigue, sleepiness; This is a spontaneous report from a contactable physician. A 44-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number EK5730), intramuscular in left arm on 19Dec2020 14:00 at a single dose for covid-19 vaccination administered in the hospital. Medical history included asthma and Known allergies to sulfa. The patient was not pregnant. The patient's concomitant medications were not reported. On 20Dec2020 14:00, the patient experienced Fatigue and sleepiness starting 24 hours after vaccination, resolved by 48 hours post vaccine. The patient did not receive any treatment for the events. The outcome of the events was recovered on 21Dec2020. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/20/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Asthma; Sulfonamide allergy,,,"['Fatigue', 'Somnolence']",1,PFIZER\BIONTECH,OT 920061,MI,28.0,F,"Chills, body aches for hours; Chills, body aches for hours; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 26Dec2020 at 18:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. Medical history included depression, chronic pain, obesity. The patient was not pregnant at the time of vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), melatonin, fluticasone propionate (FLONASE), paracetamol (TYLENOL), and ibuprofen; all for unknown indications from unknown dates and unknown if ongoing. The patient previously took cefdinir (OMNICEF) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 27Dec2020 at 5:00, the patient experienced chills and body aches for hours. The patient did not receive treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the chills and body aches for hours was not resolved. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/27/2020,1.0,PVT,LEXAPRO; ; FLONASE; TYLENOL;,,Medical History/Concurrent Conditions: Chronic pain; Depression; Obesity,,,"['Chills', 'Pain']",1,PFIZER\BIONTECH, 920062,NV,57.0,F,"allergic reactions; rash on all my chest and in abdomen; Itchiness; Eyes got red; eyes got red and itch; Chills; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2 (Lot: EH9899), via an unspecified route of administration on deltoid right on 22Dec2020 at single dose for COVID-19 immunization. Medical history included blood pressure high, hypothyroidism, and environmental allergies. Concomitant medications included amlodipine besilate (NORVASC) at 10 mg, daily for blood pressure high, and levothyroxine sodium (TIROSINT) at 112 mcg (ug) for hypothyroidism. Patient got Covid Vaccine on Tuesday (22Dec2020) night and was fine on Wednesday (23Dec2020). She expected the normal side effects like maybe a little fever like that but she believed she was having allergic reactions. It started from 24Dec2020 and she got a rash on all her chest and in abdomen and also just like itchiness feeling all over. So she took some diphenhydramine hydrochloride (BENADRYL) and a PPI 'a cup of' them on 24Dec2020 and she thought that she only had to do that one's today (25Dec2020) and the only thing she noticed when she got the shot (Covid Vaccine) they kept her there for like 15 minutes and her eyes got red and itch. She didn't scratch them but they felt like itchy and she never had that before. She never had a problem with the vaccine before. She didn't know if that was the true allergic reaction to the vaccines or if it just something she had internal allergies and she just didn't know what it was. But she was okay at the time of the report. She took some diphenhydramine hydrochloride a little while before and a PPI (unspecified medication). She was still itchy but it was not that bad and she seemed to be doing fine. Her arm was fine. She was not having any (unspecified), except sometimes. 24Dec2020 she had chills which she expected and she was all good but the side effects whatever happened that way was not the allergic portion. She tried to contact the doctor. The doctor just switched his clinic only for geriatric patients. She had to find another doctor. She knew a Doctor whom she could try and call and she actually went to the infectious disease physician and he said she should go to get the vaccine, now she was trying with that too. She got allergic to anything. Covid Shot was the only thing new that she had in her life but like she was not sure if it was triggered by something out like (unspecified) because she had always environmental allergies too. She didn't know because she was going to consult the Physician on Monday. She was just going to see the regular doctor. She was just seeing that first that anything because she knew it didn't happen very often but the Covid vaccine she just wanted to make report. She was going to the Physician on Monday because right now she thought she didn't know how long it lasted like. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/24/2020,2.0,UNK,NORVASC; TIROSINT,,Medical History/Concurrent Conditions: Blood pressure high; Environmental allergy; Hypothyroidism,,,"['Allergy to vaccine', 'Chills', 'Eye pruritus', 'Ocular hyperaemia', 'Pruritus', 'Rash']",UNK,PFIZER\BIONTECH, 920063,,42.0,F,"Loss of sense of smell, no other COVID symptoms; This is a spontaneous report from a non-contactable other healthcare professional. A 42-year-old female patient started to received first dose of BNT162B2, intramuscular (left arm), on 17Dec2020 14:00, at a single dose, for COVID-19 vaccination. The patient had no relevant medical history and was not taking concomitant medications. On 25Dec2020, the patient had loss of sense of smell; no other COVID symptoms. Outcome of the event was not recovered. No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/25/2020,8.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Anosmia'],1,PFIZER\BIONTECH,OT 920064,NC,34.0,F,"Fever; Cough; Body aches; Headache; Back pain; Dizziness; increased heart rate; Insomnia; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on right arm at 09:30 AM on 21Dec2020 at single dose for COVID-19 immunization. Medical history reported as none, no known allergies. The patient's concomitant medications were not reported. The patient experienced fever, cough, body aches, headache, back pain, dizziness, increased heart rate, insomnia at 01:00 PM on 24Dec2020. All events were reported as non-serious. The patient received Tylenol as treatment. The outcome of events was unknown. The patient was not diagnosed COVID prior vaccination, patient was not tested COVID post vaccination. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/24/2020,3.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Back pain', 'Cough', 'Dizziness', 'Headache', 'Heart rate increased', 'Insomnia', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 920065,MI,23.0,F,"Muscle aches, chills, pain at injection site; Muscle aches, chills, pain at injection site; Muscle aches, chills, pain at injection site; This is a spontaneous report from a contactable nurse, the patient. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Ek9231) solution for injection intramuscular in the left arm on 26Dec2020 at 10:30 (at the age of 23-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Dec2020 at 01:00, the patient experienced muscle aches, chills, and pain at injection site. No treatment was provided for the events muscle aches, chills, and pain at injection site. The outcome of the events muscle aches, chills, and pain at injection site was recovering. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/27/2020,1.0,PVT,,,,,,"['Chills', 'Myalgia', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 920066,TX,54.0,F,"positive with Covid; having Covid symptoms; positive with Covid; having Covid symptoms; This is a spontaneous report from a contactable nurse. A 54-year-old female patient (mother) received BNT162B2 (Batch/lot number: EK5730), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. Patient got the vaccine administered on 18Dec2020 and after that she was diagnosed positive with Covid on 24Dec2020, so now she was having Covid symptoms obviously after the vaccine but like not due to the vaccine. Reporter was just concerned what her next dose supposed to be scheduled for 08Jan2021, was she still supposed to get the second dose or what. No treatment received. Patient was just taking vitamins. Reporter also reported that typically it was not supposed to be but was trying to get the information on enhanced immune response. Outcome of the event was unknown.; Sender's Comments: The reported positive with Covid after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/24/2020,6.0,PVT,,,Medical History/Concurrent Conditions: Asthma,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 920067,,31.0,F,"Hives; This is a spontaneous report from a non-contactable physician. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Dec2020 in left arm at single dose for COVID-19 immunization. Medical history included rheumatoid arthritis and known allergies to fire ants from an unknown date and unknown if ongoing. Concomitant medication included etanercept (ENBREL) and drospirenone, ethinylestradiol (YASMIN). The patient experienced hives in Dec2020. The facility where the most recent COVID-19 vaccine was administered was on the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered in Dec2020. Therapeutic measure such as anti-histamine was taken as a result of hives. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect. No follow-up attempts are possible, information about lot/batch cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/01/2020,,PVT,ENBREL; YASMIN,,Medical History/Concurrent Conditions: Insect bite allergy; Rheumatoid arthritis,,,['Urticaria'],1,PFIZER\BIONTECH, 920068,CA,37.0,F,"Developed left facial numbness but no weakness present; This is a spontaneous report from a contactable physician (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) with unknown lot number and expiration date, intramuscularly at the left arm on 17Dec2020 at 16:15 (04:15 PM) at single dose for COVID-19 immunization. The patient was vaccinated at a hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The patient's medical history included hypothyroidism, hypertension, and premenstrual dysphoric disorder (PMDD). The patient had no allergies to medications, food, or other products. Concomitant medication included atenolol, fluoxetine hydrochloride (PROZAC), and levothyroxine; all received within 2 weeks of vaccination. The patient reported that on 17Dec2020 at 18:00 (06:00 PM), she developed left facial numbness but no weakness present. Symptoms come and go. Sometimes last for hours, never had this before. The patient did not receive treatment for the event. The clinical outcome of the event was not recovered. The event was reported as non-serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/17/2020,0.0,PVT,; PROZAC;,,Medical History/Concurrent Conditions: Hypertension; Hypothyroidism; Premenstrual dysphoric disorder,,,['Hypoaesthesia'],1,PFIZER\BIONTECH,OT 920069,CA,35.0,F,"Tachycardia to 120s; Palpitations; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration on the left arm on 19Dec2020 16:45 at a single dose for COVID-19 immunization. The patient's medical history included hypertriglyceridemia. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 19Dec2020, the patient experienced tachycardia to 120s and palpitations. No treatment was received for the events. The patient underwent lab tests and procedures which included heart rate was 120s on 19Dec2020. Outcome of the events not recovered. The events were considered non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/19/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Hypertriglyceridaemia,,,"['Heart rate', 'Palpitations', 'Tachycardia']",1,PFIZER\BIONTECH, 920070,CA,48.0,F,"Heart palpitations occurring 5-10 times a minute with sinus rhythm but irregular heart beat; Heart palpitations occurring 5-10 times a minute with sinus rhythm but irregular heart beat; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration on the left arm on 23Dec2020 09:00 at a single dose for COVID-19 immunization. The patient's medical history included allergies to dust mites, sinusitis, depression. The patient was not pregnant. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR), fluticasone propionate (FLONASE), and lamotrigine (LAMICTAL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 24Dec2020 23:00, the patient experienced heart palpitations occurring 5-10 times a minute with sinus rhythm but irregular heart beat. There is no history of any cardiovascular diseases or abnormal findings. No caffeine or alcohol intake on the day of the occurrence. No treatment was received for the adverse events. Outcome of the irregular heart beat was not recovered while of the remaining event was recovered on 25Dec2020 23:00. The events were considered non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,ALLEGRA; SINGULAIR; FLONASE [FLUTICASONE PROPIONATE]; LAMICTAL,,Medical History/Concurrent Conditions: Depression; House dust mite allergy; Sinusitis,,,"['Heart rate', 'Heart rate irregular', 'Palpitations', 'Sinus rhythm']",1,PFIZER\BIONTECH, 920071,,,U,"sudden pain in my Jaw; the left side of my face is not equal to the right side of my face; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender started to receive BNT162B2 (lot number: EK3730), via an unspecified route of administration on 17Dec2020 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Dec2020, the patient experienced a sudden pain in her/his jaw and now the left side of her/his face is not equal to the right side of his/her face. Stated, ""I am getting ready to go into the ER and I have a work-up done but I want you to know if you all as well"". The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/01/2020,,UNK,,,,,,"['Facial asymmetry', 'Pain in jaw']",UNK,PFIZER\BIONTECH, 920072,,,U,"I have been having big red circle on my arm and its swollen and it's painful; Red mark is spreading, its getting bigger and bigger; I have been having big red circle on my arm and its swollen and it's painful; I have been having big red circle on my arm and its swollen and it's painful; like starting to get itchy; This is a spontaneous report from a contactable consumer (patient). An unknown age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number and Expiration date Unknown) on 23Dec2020 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient stated had the COVID vaccine on Wednesday and within the past few days, had been having big red circle on arm and its swollen and it's painful, patient was not able to lift arm and unleash having pain, it's like starting to get itchy and arm is swollen. The red mark was spreading, it was getting bigger and bigger, it's been 2 days drew circle on it last night and this morning you can already see the red color out of the circle. Outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/01/2020,,UNK,,,,,,"['Condition aggravated', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Vaccination site erythema']",UNK,PFIZER\BIONTECH, 920073,,32.0,F,"Sore throat; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 32-year-old female patient received BNT162B2 (lot EK5730) via an unspecified route of administration on 22Dec2020 10:30 AM at a single dose as COVID-19 vaccine. Medical history was not reported. Concomitant medications included lysine supplement and loratadine (other medications in two weeks). The patient had known allergies to amoxicillin. It was reported that the patient had an adverse event of sore throat, 4 days after vaccine on 26Dec2020 14:30 (02:30 PM) assessed as non-serious. It did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). She had no other vaccine within four weeks prior to the COVID vaccine and had no Covid prior to vaccination. She had the Covid tested (other) post vaccination on 23Dec2020 with a negative result. The patient was not pregnant at the time of vaccination. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/26/2020,4.0,PVT,Lysine supplement;,,,,,"['Oropharyngeal pain', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 920074,VA,31.0,M,"Loss of sense of smell; This is a spontaneous report from a contactable physician (patient). A 31-year-old male patient received the first dose of BNT162B2 (lot EL1284) via an unspecified route of administration on 23Dec2020 07:00 (07:00 AM) at a single dose on the left arm as COVID-19 vaccine. Medical history included seasonal allergies. There were no concomitant medications. The patient had an adverse event of loss of sense of smell on 24Dec2020 assessed as non-serious. It did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. There was no treatment for the event. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). He had no other vaccine within four weeks, no other medications within two weeks prior to the COVID vaccine, and no Covid prior to vaccination. He did not have the Covid tested post vaccination. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Seasonal allergy,,,['Anosmia'],1,PFIZER\BIONTECH, 920075,VA,79.0,F,"pain under right arm pit; very stiff neck; pain radiating into ear; pains radiating down right arm, chest and back; pains radiating down right arm, chest and back; nausea; Vomiting; severe chest and back pains on right; severe chest and back pains on right; This is a spontaneous report from a contactable Other Health Professional (patient). A 79-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in right arm on 18Dec2020 08:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient medical history was not reported. Concomitant medication in two weeks included citalopram, levothyroxine, atorvastatin, anastrozol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 3rd day (21Dec2020), the patient experienced severe chest and back pains on right at time of 12:30 AM. On 4th day (22Dec2020) pains radiating down right arm, chest and back, nausea and vomiting. On 5th day (23Dec2020) pain under right arm pit, very stiff neck, pain radiating into ear. Temperature was normal. On 6th day (24Dec2020) most symptoms dissipated. On 7th day (25Dec2020) almost back to normal. No treatment received for the events. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/21/2020,3.0,PVT,; ; ; ANASTROZOL,,,,,"['Axillary pain', 'Back pain', 'Body temperature', 'Chest pain', 'Ear pain', 'Musculoskeletal stiffness', 'Nausea', 'Pain', 'Pain in extremity', 'Vomiting']",1,PFIZER\BIONTECH, 920077,,22.0,M,"Red rash on face, neck, chest and arm; difficulty swallowing; This is a spontaneous report from a contactable nurse (patient). A 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ELO140) intramuscular on 26Dec2020 18:30 (06:30 PM) at a single dose on the right arm as COVID-19 vaccine. Medical history included previously diagnosed with COVID-19 prior to vaccination. The patient had no known allergies to medications, food, or other products. There were no concomitant medications. The patient had adverse events of red rash on face, neck, chest and arm; and difficulty swallowing, both on 26Dec2020 19:00 (07:00 PM) assessed as non-serious. It did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. There was no treatment for the events. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). He had no other vaccine within four weeks prior to the COVID vaccine, no other medications within two weeks of vaccination. He did not have Covid tested post vaccination. The outcome of the events was recovered on Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,PVT,,,Medical History/Concurrent Conditions: COVID-19 (previously diagnosed with COVID-19 prior to vaccination),,,"['Dysphagia', 'Rash erythematous']",1,PFIZER\BIONTECH,OT 920078,MS,47.0,F,"All of sudden I started feeling bad, I mean it just hit me; Fever; Headache; I am very nauseous; My left arm started swelling, it started in fore arm and it started getting marks on it; pain in arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in her right arm on 21Dec2020 at single dose for covid-19 immunization. Medical history included Blood pressure high, Attention deficit hyperactivity disorder (ADD), depression and cancer four years ago and she didn't have any left node in left arm. Concomitant medications included losartan (LOSARTAN) for Blood pressure high, venlafaxine hydrochloride (EFFEXOR) as antidepressant, tamoxifen (TAMOXIFEN) for her cancer and it was hormone blocker, lisdexamfetamine mesilate (VYVANSE) for ADD. The patient received the vaccine last this last Monday on 21Dec2020, in her right arm, she was fine, on Thursday on 24Dec2020 like all of sudden she started feeling bad, she mean it just hit her. She had fever, she was very nauseous and her arm, her left arm started swelling, it started in forearm and it started getting marks on it. Anyway she went go and got tested for Covid yesterday 26Dec2020 because in middle of night, that night I felt so bad. She have got just headache on 24Dec2020, its most of that before then. Anyways she had just got her results back that was negative but so she didn't know that her arm, it was the opposite arm. The patient still experiencing pain in arm, she haven't had fever in last night and she haven't checked it today. She took Tylenol and she called her doctor yesterday and they made of me some antibiotics for her arms, probably the 7mg and the patient guess it is every 8 hours. The outcome of the event pain in arm was not recovered and the outcome of the other events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/24/2020,3.0,UNK,; EFFEXOR; ; VYVANSE,,Medical History/Concurrent Conditions: ADD; Blood pressure high; Cancer (four years ago and didn't have any left node in left her arm); Depression,,,"['Feeling abnormal', 'Headache', 'Nausea', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 920079,FL,26.0,M,"Fever; chills; headache; fatigue; injection site pain; This is a spontaneous report from a contactable physician (patient). A 26-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not available), intramuscularly on 23Dec2020 at 12:15 PM on Left arm at single dose for COVID-19 immunization in hospital. The patient medical history included asthma and previously COVID+, prior to vaccination, patient was diagnosed with COVID-19. No known allergy, no allergies to medications, food, or other products. Concomitant medications included salbutamol (ALBUTEROL), montelukast and loratadine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, headache, fatigue, injection site pain; lasted approximately 24 hours on 24Dec2020 at 12:00 AM. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included Ibuprofen. The outcome of the events was recovered in Dec2020. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,ALBUTEROL [SALBUTAMOL]; ;,,"Medical History/Concurrent Conditions: Asthma; COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?: Yes/Previously COVID+)",,,"['Chills', 'Fatigue', 'Headache', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 920080,NJ,,U,"Loss of taste; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot # EK9231, Expiration Date: Apr2021), on 23Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced loss of taste on 27Dec2020. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/27/2020,4.0,UNK,,,,,,['Ageusia'],1,PFIZER\BIONTECH, 920081,,,F,"chills; nausea; This is a spontaneous report from a contactable consumer (patient's son). A female patient of an unspecified age (reported as 62, unknown units) received bnt162b2, lot number and expiration date were unknown, via an unspecified route of administration on 24Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter asked if his mom can still go to work if she is feeling all of the symptoms. The reporter was calling on behalf of his mom (who speaks Spanish only) as she received the COVID vaccine on 24Dec2020. The patient started feeling nausea and chills as of 26Dec2020 until present. The reporter would like to know how long do the symptoms usually last. The outcome of the events was not recovered. Information for Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/26/2020,2.0,UNK,,,,,,"['Chills', 'Nausea']",UNK,PFIZER\BIONTECH, 920082,MD,31.0,F,"Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck pain (chest and back pain worse with breathing)/ Left and right neck pain; Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck pain (chest and back pain worse with breathing); Arm Pain at injection site; Arm Pain at injection site; This is a spontaneous report from a non-contactable physician (patient). A 31-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/ Lot number: EK5730), intramuscularly on 22Dec2020 09:45 at single dose on left arm for COVID-19 immunization in hospital. Medical history included gastrooesophageal reflux disease (reported as GERD). No true allergies; unable to take NSAIDs or eat bananas or avocados 2/2 GERD. Concomitant medication within 2 weeks of vaccination included colecalciferol (VITAMIN D). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm pain at injection site on Day 1 (22Dec2020); chest, back and left neck pain (chest and back pain worse with breathing) on Day 2 (23Dec2020); left and right neck pain on Day 3, resolved on Day 4. No treatment received for the adverse events. The events outcome was resolved on 25Dec2020. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: GERD,,,"['Back pain', 'Chest pain', 'Neck pain', 'Pain in extremity', 'Painful respiration', 'Vaccination site pain']",1,PFIZER\BIONTECH, 920083,CA,61.0,M,"Strong myalgias in buttocks and hamstrings bilaterally at 2 days migrating to calfs at 3 days. Dull ache pain. gone in buttock on day 3, gone in hamstrings day 4, still slight in calves.; This is a spontaneous report from a contactable physician (patient). A 61-year-old male patient received bnt162b2, lot number and expiration date unknown, at the Hospital, via an unspecified route of administration on 23Dec2020 at 11:45, at a single dose for Covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Medical history included psoriatic arthritis from an unknown date, for which patient took Enbrel 50 3 weeks prior to injection (in 2020). The patient had no known allergies. Concomitant medications included propranolol hydrochloride (INDERAL LA, 60 mg) and olmesartan medoxomil (BENICAR, 40 mg). In 26Dec2020 at 04:00, the patient experienced strong myalgias in buttocks and hamstrings bilaterally at 2 days migrating to calfs at 3 days. Dull ache pain. Gone in buttock on day 3, gone in hamstrings day 4, still slight in calves. The event was reported as non-serious. No treatment was received for the adverse event. The outcome of the event was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/26/2020,3.0,PVT,INDERAL LA; BENICAR,,Medical History/Concurrent Conditions: Psoriatic arthritis,,,['Myalgia'],UNK,PFIZER\BIONTECH, 920084,,,M,"Joint pain; Muscle pain; A slight fever of 100 F; Cough; Congestion; This is a spontaneous report from a contactable other healthcare professional (patient's wife). A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had since been working with COVID patients. Yesterday (27Dec2020) evening he woke up with joint pain, muscle pain, a slight fever of 100 F, cough and congestion. The reporter was wondering if he could still get COVID after the first shot or if it's a side effect from a vaccine. The outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/27/2020,6.0,UNK,,,,,,"['Arthralgia', 'Body temperature', 'Cough', 'Myalgia', 'Nasal congestion', 'Pyrexia']",1,PFIZER\BIONTECH, 920085,LA,47.0,F,"Rash on my back, it is very itchy; Rash on my back, it is very itchy; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female received first dose of bnt162b2 (BNT162B2 also reported as Pfizer BioNTech Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on Dec2020 at single dose (dose 1) for Covid-19 vaccination. The patient's medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID) and vitamin D. The patient experienced rash on her back, it was very itchy on an unspecified date in Dec2020. She reported that she took Benadryl but might not get any relief from it. She had lab work but it was more than 14 days ago, no results reported. The outcome of events not recovered. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/01/2020,0.0,UNK,SYNTHROID; VITAMIN D [VITAMIN D NOS],,,,,"['Laboratory test', 'Rash', 'Rash pruritic']",1,PFIZER\BIONTECH, 920086,RI,52.0,F,"intermittent numbness and tingling L arm. Sometimes radiating to my hand.; intermittent numbness and tingling L arm. Sometimes radiating to my hand.; This is a spontaneous report from a contactable nurse (patient herself). A 52-year-old female patient, not pregnant, received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer BIONTECH Covid-19 vaccine, lot EH9899, expiry date not reported), via an unspecified route of administration in the left arm on 21Dec2020 11:15, single dose (dose 1) for Covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and had drug allergy. Approximately 4days after injection (25Dec2020), the patient started having intermittent numbness and tingling in left arm that sometimes radiating to her hand. She reported that she still have these symptoms as of today. No treatment was given. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/25/2020,4.0,PVT,,,,,,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH, 920087,MI,47.0,M,"Developed right sided facial numbness; numbness of right side of anterior tongue; numbness progressed to some facial pain as well; This is a spontaneous report from a contactable Other Health Professional (patient). A 47-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the right arm, first dose given on 23Dec2020 12:30 at a single dose for COVID vaccination. Medical history included asthma, seasonal allergic rhinitis and Bell's Palsy affecting that side of the face. Concomitant medication included loratadine, pseudoephedrine sulfate (CLARITIN-D) and montelukast sodium (SINGULAIR). The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. He was not diagnosed with COVID-19 prior to and post vaccination. The patient previously took and had allergies to Keflex, Vicodin and Motrin. It was reported that the patient developed right-sided facial numbness and numbness of right side of anterior tongue. These occurred within 10- 15 minutes of vaccine administration on 23Dec2020 at 12:45 PM. It was mentioned that the patient has history of Bell's Palsy that was affecting that side of the face. The patient had numbness progressed to some facial pain as well. Symptoms lasted for 6 days and slowly abated with prednisone treatment which was given at 20 mg BID (twice a day) x 5 days. The events were reported as non-serious. The outcome of the events patient developed right-sided facial numbness and numbness of right side of anterior tongue and numbness progressed to some facial pain as well was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,CLARITIN-D; SINGULAIR,,Medical History/Concurrent Conditions: Asthma; Bell's palsy; Seasonal allergic rhinitis,,,"['Facial pain', 'Hypoaesthesia', 'Hypoaesthesia oral']",1,PFIZER\BIONTECH,OT 920088,NM,60.0,M,"Chills- HA's and feeling unwell; Chills- HA's and feeling unwell; Chills- HA's and feeling unwell; This is a spontaneous report from a contactable Other Health Professional (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH 9899, intramuscular in the Arm Right, first dose on 16Dec2020 18:45 (or 06:45 PM) at a single dose for Covid-19 immunization. Medical history included blood pressure abnormal (reported as BP). The patient's concomitant medication included unspecified statin for BP. The patient had not received any other vaccine in four weeks. The patient experienced chills, HA (headache), was feeling unwell X four events (pending clarification) on 16Dec2020 (onset time at 0200, pending clarification) with outcome of Recovered/Resolved with sequel. The events were reported as non-serious which requires sleep and rest. The patient was not diagnosed with COVID-19 prior to vaccination nor was she tested since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/16/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure abnormal,,,"['Chills', 'Headache', 'Malaise']",1,PFIZER\BIONTECH,OT 920089,,,M,"of low grade fever, pain at injection site and malaise on the first few days. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia; of low grade fever, pain at injection site and malaise on the first few days. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia; of low grade fever, pain at injection site and malaise on the first few days. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia; of low grade fever, pain at injection site and malaise on the first few days. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia; This is a spontaneous report from a contactable physician. A 61 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown since misplaced/discarded) via an unspecified route of administration on an unspecified date in 2020 at a single dose for COVID-19 immunization. The patient had dengue fever in 2018. The patient concomitant medications were not reported. Caller requested information for her husband who received the Covid 19 vaccine. Vaccine recipient was ""asymptomatic"" with a report of low grade fever, pain at injection site and malaise on the first few days in 2020. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia. Caller stated her husband tested negative for Covid, flu and rsv post vaccination and blood work comes back good in 2020. Caller wanted to know if her husband should get the second dose of the Covid 19 vaccination. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Dengue fever,,,"['Body temperature', 'Influenza virus test', 'Investigation', 'Malaise', 'Myalgia', 'Pyrexia', 'Respiratory syncytial virus test', 'SARS-CoV-2 test', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 920090,FL,58.0,M,"sinus issues; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; right arm sore; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a 58-year-old male patient received the first dose of BNT162B2 (lot number: EH9899; Expire Date: 31Mar2021), via an unspecified route of administration, in arm, right upper, on 16Dec2020 11:10 AM at single dose for COVID-19 immunization. The vaccination facility type was hospital. The vaccine was not administered at military facility. Patient's medical history (including any illness at time of vaccination) was none. The patient got ill from all pain medications- from prescription strength pain killers to OTC products such as tylenol, ibuprofen and aspirin. All of them make him sick- experienced hot flashes and nausea. No additional vaccines administered on same date of the Pfizer suspect vaccine. Prior vaccinations (within 4 weeks) was none. The concomitant medication included 2 different blood pressure pills, mentioning Lisinopril, but stated he did not think his blood pressure pills were relevant to what he was experiencing with the COVID-19 Vaccine. A MRI tech (clarified by caller as MRI technologist) at a hospital who received the COVID-19 Vaccine on 16Dec2020 (caller clarified he received the vaccine at 11:10 AM on 16Dec2020). Caller stated on 17Dec2020 he had signs of aches and pains allover, a sore arm (clarified as his right arm), no fever. He also experienced sinus issues and a loss of sense of smell. Clarified his right arm was sore for only a day, his sinus issues started on 20Dec2020, and his loss of the sense of smell gradually started on 22Dec2020. He stated on 23Dec2020 he had a COVID-19 test performed and the test result was positive for the COVID-19 virus. Caller asked since he had the first COVID-19 Vaccine dose, and has now tested positive for the COVID-19 virus, should he get the second COVID-19 Vaccine dose scheduled for 06Jan2021. Patient's Height: 5' 8'' as provided by caller, who stated he has shrunk 1''. No further details provided. Patient's Weight: 169 lbs. as provided by caller, who stated his weight was as of today. Reported he worked an overnight shift, clarifying he was injected with the COVID-19 Vaccine after his overnight shift was finished on the morning of 16Dec2020. He stated he came back to work later in the day on 16Dec2020 to work another overnight shift from 9:00 PM to 7:30AM. He said after he finished is overnight shift on the morning of 17Dec2020, he went home to bed, and woke up around 12:00 PM on 17Dec2020. He said when he woke up, he started to feel aches and pains allover, and after that noticed he was getting chills periodically. Clarified he experienced the aches and pains allover for a couple of days, and then the aches and pains went away. He said he then started to get the feeling a sinus infection was coming on, but he never got a sinus infection. He said the aches, pains, and chills came back. Reported his co-worker received the COVID-19 Vaccine on Saturday, 19Dec2020, clarifying his co-worker did well with the COVID-19 Vaccine. He clarified his employer was concerned that he may have exposed his co-worker to COVID-19 when the two worked together on the overnight shift of 22Dec2020. He said both he and his coworker kept their PPE on the whole time they worked except when the two ate dinner. He said the two of them sat at a round table about 6 feet apart, and took off their masks to eat. He said his partner agreed that the two of them were right at 6 feet apart when the sat at the table to eat dinner, so their employer deemed his coworker as low risk. Reported on 22Dec2020 he had to go back to work, so he was asked for his temperature at the time, which was 98.8 degrees. He did have a flu shot previously. He was instructed as long as he doesn't have a fever over 100 degrees, he can work. The caller said he went to work on 22Dec2020, and read an email from his employer's wellness office. He said the wellness office email spoke about the COVID-19 Vaccine side effects, and instructed employees to contact the wellness office with any COVID-19 Vaccine side effects experienced. He said he left a voicemail with his employer's wellness office explaining exactly what his COVID-19 Vaccine side effects were. He said he instructed his employer's wellness office call him in the afternoon because he was going to go home, go to bed, and wake up at noon on 23Dec2020. He stated he spoke with his employer's wellness office at around 11:30 AM on 23Dec2020, and the wellness office asked for him to go to the hospital, and have a COVID19 test. Caller stated his employer performed a COVID-19 nasal swab test, and on 24Dec2020, he was told he was COVID-19 positive. He said his employer backed up his quarantine start date to 17Dec2020 (the first day he experienced symptoms), and had him follow a 10-day quarantine until 27Dec2020. He stated today, 28Dec2020, was the first day he has been off quarantine. Reported he was not saying he got COVID-19 from receiving the COVID-19 Vaccine, but should he have the second COVID-19 Vaccine injection. Clarified his symptoms were intermittent, and started coming back around 20Dec2020. Reported he was not experiencing any scratchiness in his throat, and his eyes were not watering. He said he has had no cough, no sneezing, and no trouble breathing. He said in general, it felt like something was coming on, saying it was building up, but not getting out. Clarified he had gone back to work on 23Dec2020 to have his COVID-19 nasal swab test performed, and was told by his employer on 24Dec2020 that the COVID-19 nasal swab test was positive. No AE required a visit to emergency room or physician office. The outcome of the event right arm sore was recovered on 18Dec2020 and the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/17/2020,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Anosmia', 'Chills', 'Pain', 'Pain in extremity', 'Quarantine', 'SARS-CoV-2 test positive', 'Sinus disorder']",1,PFIZER\BIONTECH, 920091,FL,51.0,F,"waves of nausea for 2 days after; Dizziness; headache; difficulty with higher thought processes - feeling ""zoned out""; difficulty with higher thought processes - feeling ""zoned out""; This is a spontaneous report from a contactable other healthcare professional (patient). A 51-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number unknown due to not available/provided to reporter at the time of report completion), intramuscular at left arm on 23Dec2020 09:00 at single dose for COVID-19 immunization at a ""Nursing Home/Senior Living Facility"". The patient's medical history included Gluten and FODMAP food allergy. Concomitant medications received within 2 weeks of vaccination: dietary supplements. No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested for COVID-19 post the vaccination. COVID-19 test post vaccination on 23Dec2020 result was negative. It was reported that on 23Dec2020 09:30, the patient experienced dizziness, headache, difficulty with higher thought processes - feeling ""zoned out"", and ""waves of nausea for 2 days after"". No treatment was taken for the above events. The outcome of the events was recovered in Dec2020. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,Medical History/Concurrent Conditions: Food allergy (Gluten and FODMAP food allergy); Gluten sensitivity (Gluten and FODMAP food allergy),,,"['Dizziness', 'Feeling abnormal', 'Headache', 'Nausea', 'SARS-CoV-2 test', 'Thinking abnormal']",1,PFIZER\BIONTECH,OT 920092,MN,53.0,F,"Recurrence of redness, swelling, pain at injection site/Site reaction is identical to initial reaction occurring on days 2 and 3; Recurrence of redness, swelling, pain at injection site/Site reaction is identical to initial reaction occurring on days 2 and 3; Recurrence of redness, swelling, pain at injection site/Site reaction is identical to initial reaction occurring on days 2 and 3; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in the right arm on 19Dec2020 at 10:15 AM in a hospital at a single dose for COVID-19 immunization. Medical history included asthma and GERD. The patient was not pregnant at the time of vaccination and had no known allergies. The patient had no other vaccine in four weeks, had no COVID-19 diagnosis prior to vaccination, and was not tested for COVID-19 post vaccination. Concomitant medication included omeprazole (PRILOSEC). On 27Dec2020 at 18:00, the patient experienced a recurrence of redness, swelling, and pain at injection site measuring 5.5 cm x 5.6 cm occurring on day 9 post injection. Site reaction was identical to the initial reaction occurring on days 2 and 3 of Dec2020, which resolved by day 4. The patient received no treatment for the events. Outcome of the events was not recovered/not resolved. Information about the lot/batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/01/2020,,PVT,PRILOSEC [OMEPRAZOLE],,Medical History/Concurrent Conditions: Asthma; GERD,,,"['Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 920093,AZ,27.0,F,"Sore arm; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH9899), via an unspecified route of administration on 28Dec2020 at 08:30 AM at a single dose; and the first dose via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination, had no known allergies, and did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. The patient experienced sore arm on 28Dec2020 at 09:00. The patient received no treatment for the event. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/28/2020,,OTH,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 920094,IL,50.0,F,"In response to the vaccine on 21Dec2020 I started to get a headache; This is a spontaneous report from a contactable nurse (patient). An 50-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH9899), via an unspecified route of administration in the left arm on 21Dec2020 at 12:00 PM in a hospital at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination, had no known drug allergies (NKDA), and did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included diazepam (VALIUM). In response to the vaccine on 21Dec2020, the patient started to get a headache, 600 mg ibuprofen was taken. Overnight, she woke up with a debilitating headache, stayed in bed on 22Dec2020 taking Tylenol 1000 mg q (every) 8 hours and Ibuprofen 600 mg q (every) 6 hours to keep the headache manageable. The entire week, she had 2 days where if she didn't keep rotating the doses of Tylenol and Ibuprofen, the headache would become severe. The side effects included ""headache"" but this was no common headache and she was not a person who routinely gets them. It has been a week since the injection and she still had to continue the cycling of Tylenol/ibuprofen to maintain this headache, to continue ADL's. Outcome of the event was not recovered. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,PVT,VALIUM,,,,,['Headache'],UNK,PFIZER\BIONTECH, 920095,CA,39.0,F,"developed a severe tachycardia with no other symptoms.; was nervous and kind of shaking; was nervous and kind of shaking; Allergic reaction; This is a spontaneous report from a contactable pharmacist. A 39-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJ1685), intramuscular in the left arm on 24Dec2020 at 08:00 AM in the hospital at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination, has no known allergies, had no other medications in two weeks, and did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. At 3:00 PM of 24Dec2020, the patient developed a severe tachycardia with no other symptoms. She walked herself to the ER (Emergency room/department or urgent care), was nervous and kind of shaking. By the time they got to her, her heart rate was stable and was at 88. Transient tachycardia was at around 120-140 for 7 minutes and resolved with no intervention. Basic labs came back normal. She got discharged from the ER. The patient didn't think they reported it but she was willing to cooperate in any way. The patient was not treated for the adverse events. As per the patient, she reported her adverse reaction (after the 1st dose) on the website as recommended. She experienced ""very fast heart beat 8 hours after receiving the vaccine"". The patient was inquiring if she would be contacted after. The patient also asked if the very fast heartbeat was related to the vaccine because the reaction did not happen right away like usual, she was not sure if it was an allergic reaction since it happened 8 hours later. Outcome of the event 'Tachycardia' was recovered in Dec2020, while for the other events was unknown. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,,,,,,"['Heart rate', 'Hypersensitivity', 'Investigation', 'Laboratory test', 'Nervousness', 'Tachycardia', 'Tremor']",1,PFIZER\BIONTECH,OT 920096,CA,30.0,F,"It felt a little numb on the part that was injected; I kept filling the medicine drip from my nose and since then I have been having really bad cough; I kept filling the medicine drip from my nose and since then I have been having really bad cough; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no concomitant medications. The patient stated that she believed she had a little bit side effects on the vaccine in Dec2020. She took the vaccine about maybe more than a week ago and yesterday it felt a little numb on the part that was injected and she kept ""filling the medicine"" drip from her nose and since then she had been having really bad cough. The patient stated that for her cough, she took natural stuffs (unspecified). Outcome of the events was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Cough', 'Upper-airway cough syndrome', 'Vaccination site hypoaesthesia']",UNK,PFIZER\BIONTECH, 920097,AL,40.0,F,"Asthma exacerbation; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Lot number: ek5730), via an unspecified route of administration at the left arm on 18Dec2020 13:00 at a single dose for COVID-19 immunization. Medical history includes adult onset asthma, seasonal allergies, anxiety and depression. The patient was not pregnant at the time of vaccination. Concomitant medication included atomoxetine hydrochloride (STRATTERA), vortioxetine hydrobromide (TRINTELLIX), ethinylestradiol and levonorgestrel (SEASONIQUE). The patient experienced asthma exacerbation following vaccination that started 2 hours after (18Dec2020, 3PM) and worsened 1 day later. The pulmonologist advised to nebulize the patient with albuterol due to shortness of breath tightness and clear secretions despite MDI. The patient had to restart controller Symbicort (still with 3x day albuterol on 23Dec2020) and seen at an urgent care. Oral steroids were prescribed (Medrol dose pack). The patient was not hospitalized for the event but the resulted in Emergency room/department or urgent care visit. The event was reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has been tested for Flu and COVID (Nasal Swab, PCR) Testing on 23Dec2020 and results were negative. The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,STRATTERA; TRINTELLIX; SEASONIQUE,,Medical History/Concurrent Conditions: Adult onset asthma; Anxiety; Depression; Seasonal allergy,,,"['Asthma', 'Influenza virus test', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 920098,,,F,"burning itching and having welts over her body; burning itching and having welts over her body; This is a spontaneous report from a non-contactable other healthcare professional (technologist, patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in Dec2020, the patient experienced burning itching and having welts over her body. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/01/2020,,UNK,,,,,,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH, 920099,TX,39.0,F,"heart palpitations; felt like heart was skipping a beat almost every 3-5 minutes; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration at the right arm on 21Dec2020 08:00 at a single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination and had no known allergy. The patient had no concomitant medications. On 23Dec2020 at 11 pm, approximately 36 hours after getting vaccine, the patient had 36+ hours of heart palpitations, felt like heart was skipping a beat almost every 3-5 minutes. Events subsided after 36-48 hours. The patient was not hospitalized for the events. There was no treatment given for the events. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/23/2020,2.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Extrasystoles', 'Heart rate', 'Palpitations']",1,PFIZER\BIONTECH, 920100,IN,37.0,F,"Headache; nausea; arm pain at the injection site; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ek5730), intramuscular at the left arm on 23Dec2020 14:30 at a single dose for COVID-19 immunization. Medical history included anxiety. The patient was not pregnant at the time of vaccination and had no known allergy. Concomitant medication included trazodone and fluoxetine hydrochloride (PROZAC). On 24Dec2020 6 am, the patient experienced headache and moderate nausea for about 48-32 hours with significant arm pain at the injection site. The patient was not hospitalized for the events and did not receive any treatment. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,; PROZAC,,Medical History/Concurrent Conditions: Anxiety,,,"['Headache', 'Nausea', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 920101,,60.0,F,"Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a non-contactable other-HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231) (Brand= Pfizer), via an unspecified route of administration on 24Dec2020 07:15AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was workplace clinic. None medical history. The patient's concomitant medications was not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies included Ibuprofen based pain medicine. On 24Dec2020, patient experienced injection site pain; chills; facial flushing. 25Dec2020 fever. 26Dec2020 rhinorrhea. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'Chills', 'Flushing', 'Pyrexia', 'Rhinorrhoea', 'Vaccination site pain']",1,PFIZER\BIONTECH, 920102,TX,59.0,F,"Fine raised red rash over her body; throat swelling; diarrhea; high pitched cough productive with clear thin secretions; This is a spontaneous report from a contactable nurse (patient herself). A 59-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on left arm from at 12:30 PM on 23Dec2020 at single dose for COVID-19 immunization. Medical history included depression. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), triazolam (HALCION), fluoxetine hydrochloride (PROZAC), paracetamol (TYLENOL). The patient previously took Lamictal and experienced rash, codeine and experienced hallucination, lamictal for drug allergy, codeine and experienced drug allergy. On 24Dec2020 mid-day (11:00 AM), the patient developed the following S/S (signs and symptoms, which were similar to a Lamictal rash): Fine raised red rash over her body, but significantly heavier to face, neck and lower legs; throat swelling with a high pitched cough (with no difficulty breathing) productive with clear thin secretions; diarrhea. The patient took 6 Benadryl every 4-6 hours, Pepcid twice daily, and had an epi pen available (but did not need it). The cough and rash resolved by late Sunday evening (27Dec2020). The patient did not report to ED because she felt the symptoms were manageable at home. All events reported as non-serious. The outcome of events red rash and cough were recovered on 27Dec2020, the outcome of rest events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,WELLBUTRIN; HALCION; PROZAC; TYLENOL,,Medical History/Concurrent Conditions: Depression,,,"['Diarrhoea', 'Pharyngeal swelling', 'Productive cough', 'Rash erythematous']",1,PFIZER\BIONTECH, 920103,CT,51.0,F,"numbness and itching in the roof of mouth; numbness and itching in the roof of mouth; This is a spontaneous report from a contactable healthcare professional. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ 1685), intramuscular on the left arm on Dec2020 at single dose for COVID-19 immunisation. Medical history included hypertension and GERD. Concomitant medication included metoprolol, dexlansoprazole, ondansetron and propranolol. The patient previously took gadolinium and midazolam and experienced known allergies: gadolinium and midazolam. The patient experienced numbness and itching in the roof of mouth on Dec2020. Patient received BENADRYL as treatment. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/01/2020,0.0,PVT,; ; ;,,Medical History/Concurrent Conditions: GERD; Hypertension,,,"['Hypoaesthesia oral', 'Oral pruritus']",1,PFIZER\BIONTECH,OT 920104,TX,31.0,F,"Intermittent dizziness and it doesn't last very long usually its usually couple of times a day; This is a spontaneous report from a contactable nurse, the patient. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot ""EJ then it's either I or 1, I don't know then 685"", Expiry Date: 31Mar2021) solution for injection intramuscular on 19Dec2020 (at the age of 31-years-old) as a single dose for COVID-19 vaccination. Pregnancy status was not reported. Medical history was unknown. Concomitant medication included multivitamins. The patient stated, ""I just wanted to know if it's normal or not, I got this first half of the Covid Vaccine on the 19Dec2020 and ever since I have been having like intermittent dizziness (19Dec2020) and it doesn't last very long usually its usually couple of times a day but I just wanted to know if that's normal and if it is how long before it stops?"" No treatment was provided for the event intermittent dizziness. The outcome of the event intermittent dizziness was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/19/2020,0.0,PVT,MULTIVITAMINS [VITAMINS NOS],,,,,['Dizziness'],1,PFIZER\BIONTECH,OT 920105,,,M,"patient had COVID two days after vaccination; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) via an unspecified route of administration on 26Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had COVID two days after vaccination (28Dec2020). The outcome of the event was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/28/2020,2.0,UNK,,,,,,['COVID-19'],UNK,PFIZER\BIONTECH, 920106,FL,,F,"Fever of 101 Chills; body aches; ocular migraine; abdominal cramping and pain; This is a spontaneous report received from a contactable Pharmacist. A female patient of unspecified age (reported as ""44 without unit"") received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ett9899) via Intramuscular on 18Dec2020 13: 00 at single dose in the arm left for COVID-19 immunisation. Medical history was none. Concomitant medications included claritin, OCP. The patient previously took cephalosporin and experienced allergy. The patient experienced Fever of 101 Chills, body aches, ocular migraine, then developed abdominal cramping and pain at 18Dec2020 19:00. Symptoms lasted 3 days and then completely resolved. Adverse events result in emergency room/department or urgent care. The patient received treatment for events and underwent lab tests, which included CT of Head. Outcome of events was recovered on 22Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,CLARITIN [CLARITHROMYCIN],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Abdominal pain', 'Body temperature', 'Computerised tomogram', 'Migraine', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,OT 920107,TX,,U,"dizzy; weak; S/He had started feeling really bad; s/he didn't feel well; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) via an unspecified route of administration on 15Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 27Dec2020, the patient started feeling dizzy and weak. S/He had started feeling really bad; s/he didn't feel well. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/15/2020,12/27/2020,12.0,UNK,,,,,,"['Asthenia', 'Dizziness', 'Malaise']",UNK,PFIZER\BIONTECH, 920108,AZ,29.0,F,"four days after getting her first COVID vaccine injection, she had a COVID positive test result (antigen rapid response test); four days after getting her first COVID vaccine injection, she had a COVID positive test result (antigen rapid response test); This is a spontaneous report from a contactable consumer. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730/expiration date unknown), dose number 1 via an unspecified route of administration on 23Dec2020 09:00 at a single dose on the left arm for COVID-19 immunization. Medical history included vaccination of unspecified flu vaccine in Oct2020. No vaccines or new medications were received on the day of the vaccination. The patient stated that on 27Dec2020, four days after getting her first COVID vaccine injection, she had a COVID positive test result (antigen rapid response test). The patient stated that she had been mostly asymptomatic for COVID. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/27/2020,4.0,UNK,,,Medical History/Concurrent Conditions: Flu vaccination,,,"['Asymptomatic COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 920109,PA,25.0,F,"My eyes were glassy; Lightheadedness and dizziness; Fatigue; Low-grade temperature of 99.0 F with chills; Low-grade temperature of 99.0 F with chills; This is a spontaneous report from a contactable nurse (patient herself). This 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140), via intramuscular, on 23Dec2020 at 13:45 at single dose for COVID-19 immunisation Vaccine location was left arm. The patient was not pregnant. The patient was vaccinated at hospital, age at vaccination was 25-year-old. Relevant medical history included ongoing irritable bowel syndrome, ongoing allergies tree nuts and peanuts. Past drug history included allergy to penicillin. Relevant concomitant medications included famotidine, sertraline, and ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) for birth control. No other vaccine was received in four weeks At approximately 16:00 on 23Dec2020, she had sudden onset of fatigue, a low-grade temperature of 99.0 F with chills. By 17:30, she was also bringing to experience lightheadedness and dizziness. That night at approximately 22:00, she had temperature of 99.1. On 24Dec2020, she experienced lightheadedness and dizziness the entire day, from waking up to going to bed later that night. Her eyes were glassy and she would feel an impulse of dizziness go distinctly from the right side of her head to the left, and then felt more dizzy after that. It was constant throughout the entire day and would occur while she was sitting, standing, or moving around. On 25Dec2020, she was tired but the dizziness had gone away. Pre-vaccination and post-vaccination COVID tests were not performed. No therapeutic measures were taken as result of the events. The patient had recovered from the events in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,; SERTRALINE HCL; JUNEL FE,Allergy to nuts; Irritable bowel syndrome; Peanut allergy,,,,"['Body temperature', 'Chills', 'Dizziness', 'Fatigue', 'Glassy eyes', 'Pyrexia']",1,PFIZER\BIONTECH,OT 920110,,,F,"Fever; headache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced fever and headache for almost 10 days in Dec2020. The outcome of the events was not recovered. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Headache', 'Pyrexia']",UNK,PFIZER\BIONTECH, 920111,CA,58.0,F,"intermittent Heart palpitations that began at 0800; Severe fatigue that began 4 hours post injection and lasted approx 48 hrs; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received their first dose of BNT162B2 (lot number: Ek 5730; expiry date not reported), intramuscularly on the right arm on 26Dec2020 at 08:30 at single dose for COVID-19 immunization. Medical history included known allergies to milk and eggs. Concomitant medication included lisinopril. The patient experienced severe fatigue that began 4 hours post injection and lasted approx. 48 hrs on 26Dec2020 and intermittent heart palpitations that began at 08:00 on 28Dec2020. The patient recovered from severe fatigue on an unspecified date in Dec2020 (reported as approx. 48hrs) while the outcome of intermittent heart palpitations was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Egg allergy; Milk allergy,,,"['Fatigue', 'Palpitations']",1,PFIZER\BIONTECH,OT 920112,IA,59.0,F,developed shingles outbreak 4 days later; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on 22Dec2020 at single dose in the upper arm via unspecified route of administration. The patient had not medical history. Concomitant medications were not reported. On 26Dec2020 the patient developed shingles outbreak. The outcome of the event was not recovered. Information on the lot/batch number has been requested,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/26/2020,4.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Herpes zoster'],UNK,PFIZER\BIONTECH, 920113,CA,41.0,M,"Fever of 101.0 F; chills with fever; fatigue; night sweats; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 20Dec2020 15:00 at single dose for COVID-19 immunization. Vaccine location provided as Left arm. Medical history included Scleroderma, interstitial lung disease. There were no Known allergies to medications, food, or other products. Concomitant medication (reported as other medications the patient received within 2 weeks of vaccination) included ibuprofen, ergocalciferol (VITAMIN D), cetirizine hydrochloride (CITIRIZINE), famotidine. There were no other vaccines received within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior vaccination. The patient experienced Fever of 101.0 F, chills with fever, fatigue, night sweats on 21Dec2020 20:00. No treatment received for all reported events. The patient had Covid tested via Nasal Swab post vaccination with PCR result negative on 23Dec2020. The outcome of the events was recovered in Dec2020. This case was assessed as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/21/2020,1.0,UNK,; Vitamin D; CITIRIZINE [CETIRIZINE HYDROCHLORIDE];,,Medical History/Concurrent Conditions: Interstitial lung disease; Scleroderma,,,"['Body temperature', 'Chills', 'Fatigue', 'Night sweats', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 920114,,,U,"tested positive after receiving the first dose; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events in two patients. This is the first of two reports. A patient of unspecified age and gender received their first dose of BNT162B2 (lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter queried on after low long will the antibodies be present after receiving first dose and would it show up in antibody testing. Further reported they have 1-2 patients who tested positive after receiving the first dose. The reporter also queried any recommendations on vaccinating them for the 2nd dose if they test positive in between the two doses and that they have one vial left over from last week, today at noon the 5days will expire. If they dilute it now at 10am do they have to use it by noon or add 6hours from the time of dilution. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on an unspecified date. The outcome of the event was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020516039 same drug and event in a different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['SARS-CoV-2 antibody test', 'SARS-CoV-2 antibody test positive']",1,PFIZER\BIONTECH, 920115,,,U,"tested positive after receiving the first dose; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events in two patients. This is the second of two reports. A patient of unspecified age and gender received their first dose of BNT162B2 (lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter queried on after low long will the antibodies be present after receiving first dose and would it show up in antibody testing. Further reported they have 1-2 patients who tested positive after receiving the first dose. The reporter also queried any recommendations on vaccinating them for the 2nd dose if they test positive in between the two doses and that they have one vial left over from last week, today at noon the 5days will expire. If they dilute it now at 10am do they have to use it by noon or add 6hours from the time of dilution. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on an unspecified date. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020516038 same drug and event in a different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['SARS-CoV-2 antibody test', 'SARS-CoV-2 antibody test positive']",1,PFIZER\BIONTECH, 920116,TN,37.0,F,"Headache; soreness at injection site; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown since misplaced/discarded) via intramuscular on 26Dec2020 17:30 on left arm at a single dose for COVID-19 immunization. The patient medical history included anxiety and attention deficit hyperactivity disorder (ADHD). The patient allergy for reglan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included atomoxetine hydrochloride (STRATTERA) and sertraline hydrochloride (ZOLOFT). The patient experienced Headache, soreness at injection site, nausea, fatigue on 27Dec2020 08:00 AM. The patient received Excedrin as treatment for the events. The outcome of the events was recovering. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/27/2020,1.0,PVT,STRATTERA; ZOLOFT,,Medical History/Concurrent Conditions: ADHD; Anxiety; COVID-19,,,"['Fatigue', 'Headache', 'Nausea', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 920117,CA,50.0,F,"body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to explain it very well; change of sense of taste; loss of taste; body rash on upper torso only described as ""not bad"" and ""not itchy"" or bothersome; low grade fever 100.3; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration in left upper arm, on 21Dec2020 06:30 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital.The patient's weight was 67.13 kg and height was 173 cm. The patient's medical history included nausea and flu like symptoms. Concomitant medications included omeprazole(PROTONIX) from Dec2020 at 40mg once a day for nausea. The patient stated that a week before she received the vaccine she had flu like symptoms and she was tested for COVID-19 and the test result was negative in Dec2020. The patient experienced low grade fever 100.3 which started in the evening of the vaccine(21Dec2020) and she took Tylenol and went to sleep and the next day felt better, which resolved by the next day(22Dec2020). The patient experienced body aches on an unknown date, body rash on upper torso only described as ""not bad"" and ""not itchy"" or bothersome which started on 21Dec2020(a few hours after receiving vaccine) and resolved on 23Dec2020. The patient experienced change of sense of taste, ""everything tastes metallic and it's kind of hard to explain it very well"" on 24Dec2020. The patient experienced loss of tastewhich started on either 23Dec2020 or 24Dec2020. She was starting to be able to taste. She has anything it is bland. She can taste some saltiness. That started coming back on approximately Saturday, 26Dec2020. The patient experienced decreased appetite, ""cotton mouth"" on an unknown date. The outcome of the events ""low grade fever 100.3"", ""body rash on upper torso only described as ""not bad"" and ""not itchy"" or bothersome"", ""loss of taste"" was recovered and of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,PROTONIX [OMEPRAZOLE],,Medical History/Concurrent Conditions: Flu like symptoms; Nausea,,,"['Ageusia', 'Body temperature', 'Decreased appetite', 'Dry mouth', 'Dysgeusia', 'Pain', 'Pyrexia', 'Rash', 'SARS-CoV-2 antibody test', 'Taste disorder']",1,PFIZER\BIONTECH, 920118,NC,34.0,F,"raised bumps/hives all over body; Generalized Rash that is itchy; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received their first dose of BNT162B2 (lot number: ER5730; expiration date unknown), via an unspecified route of administration on the right arm on 20Dec2020 at 11:30 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included amoxicillin. The patient experienced Generalized Rash that is itchy, raised bumps/hives all over body on 27Dec2020. Therapeutic measures were taken as a result of the events which included treatment with hydroxyzine. The patient did not recover from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/27/2020,7.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Rash pruritic', 'Urticaria']",1,PFIZER\BIONTECH, 920119,PA,52.0,F,"Wheezing; Cough; Profound sleepiness; This is a spontaneous report from a contactable other healthcare professional (HCP). A 52-year-old female patient received the first dose of bnt162b2 (lot number: EK9231), intramuscular on the left arm on 24Dec2020 at 11:30 at a single dose for immunization. Medical history included HBP, asthma, radicular pain and migraines. The patient's concomitant medications were not reported. The patient previously took tetracycline and experienced drug allergy. The facility where the most recent COVID-19 vaccine was administered was at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 and has not been tested for COVID-19. On 26Dec2020 at 05:00, the patient experienced wheezing, cough and profound sleepiness, and was prescribed Proair Inhaler as treatment for the events. The outcome of the events was not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/26/2020,2.0,PVT,,,Medical History/Concurrent Conditions: Asthma; Blood pressure high; Migraine; Radicular pain,,,"['Cough', 'Somnolence', 'Wheezing']",1,PFIZER\BIONTECH,OT 920120,OK,46.0,F,"ringing in the ears; slight headache; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the first dose of bnt162b2 (Batch/lot number: EH9899), via an unspecified route of administration (reported as one injection to left arm) on 16Dec2020 at a single dose for COVID-19 vaccination. Medical history included allergy. Concomitant medication included prednisolone acetate (PREDNISOLONE ACETATE, Manufacturer: Pacific Pharma. NDC: 60758119-05, Lot: E88990, Exp. date: Feb2023) 1%, four eyedrops a day until she is out, 7 days at most or a week for allergy. The nurse called as a patient about the Pfizer COVID-19 vaccine, which she received on 16Dec and had a headache - only a slight headache, the day after and ringing in her ears that has not gone away. She says it was her first injection of the vaccine. The patient says she was given the vaccine through her work, and says she had a headache that evening and then a slight headache the next day. She says that the ringing in the ear, she noticed the next day in the morning. She says it is hard to tell if the ringing is just one ear or not, the ringing is staying about the same, and is more in her right ear. She says she has not had treatment for either the headache or the ringing in her ears, and the headache improved on its own. She had no new medications and didn't receive any other vaccines when she got this one. She says that she went to the eye doctor in the past week and he started her on eye drops, she has never been on prednisone for allergies, and for her eyes he gave her prednisone drops and allergy drops. She says she started that medication on the evening she got it, Monday 21Dec. She would like to know if there could be some type of allergy, she doesn't know if she should take the second dose of the vaccine. She says she doesn't know if there is something she should do for the ringing in her ears, like a common treatment or anything, or if others have been reporting this. She says she saw on the website that one side effect said ringing in ears, but she isn't sure if the website was either of those provided by call handler for further information. The outcome of the events slight headache was resolving while ringing in the ears had not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/16/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Allergy,,,"['Headache', 'Tinnitus']",1,PFIZER\BIONTECH, 920121,,,F,"angioedema; swelling of the lips; This is a spontaneous report from a non-contactable nurse (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as COVID-19 vaccine. Medical history included angioedema 23 years ago. Concomitant medications were not reported. The caller wanted to report AE for the COVID-19 vaccine. AE reported that she took the COVID-19 vaccine and after 23 hours, she developed angioedemia on unspecified date. Additionally, she said that she woke up with swelling of the lips on an unspecified date. Given the AE from the first request, it was inquired if it was recommended to get a second dose. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of angioedemia with lip swelling cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Angioedema (23 years ago),,,"['Angioedema', 'Condition aggravated', 'Lip swelling']",1,PFIZER\BIONTECH, 920122,,,F,"she had a rapid test performed which indicated a positive test result; she had a rapid test performed which indicated a positive test result; This is a spontaneous report from a contactable nurse (patient). A female patient of unspecified age received the first dose of BNT162B2, via an unspecified route of administration on 18Dec2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient indicated she received the first dose of the vaccine on the 18th and due to a family member testing positive, she had a SARS-CoV-2 rapid test performed in Dec2020 which indicated a positive test result. Her employment was questioning as to whether this is due to her receipt of vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported information is limited. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/01/2020,,UNK,,,,,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 920123,,29.0,F,"resident (patient) tested positive for COVID, 10 days after the first dose of COVID vaccine; resident (patient) tested positive for COVID, 10 days after the first dose of COVID vaccine; This is a spontaneous report from a contactable physician via a Pfizer sponsored program Pfizer First Connect. A 29-year-old female patient received their first dose of BNT162B2 (lot number and expiry date not reported), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter wanted to know how long they have to wait for the second dose of the COVID vaccine as her resident (patient) tested positive for COVID on 27Dec2020, 10 days after the first dose of COVID vaccine given to her on the 17Dec2020. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 27Dec2020. The outcome of the events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the reported events of LOE and SARS-CoV-2 test positive, based on temporal relationship. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/27/2020,10.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 920124,AZ,66.0,M,"he couldn't take a deep breathe; smothering feeling; felt an out of body; light headedness; This is a spontaneous report from two contactable physician received via Medical Information Team. A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right shoulder on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that: ""on 23Dec2020, a minute after vaccination he felt as if he couldn't take a deep breathe, it was like a smothering feeling, then he felt an out of body and light headedness, this only lasted for 3 minutes"". The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test which resulted negative and SARS-CoV-2 test: no positive results for the COVID Test prior to the vaccine. The patient outcome of the events was recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,UNK,,,,,,"['Dizziness', 'Dyspnoea', 'Feeling abnormal', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 test', 'Suffocation feeling']",1,PFIZER\BIONTECH, 920125,AZ,43.0,F,"fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was something hot going through my body; She said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot.; It made it hard to breathe; felt like a rush of hot and felt horrible; My heart rate and BP was high; My heart rate and BP was high; she looked pale, and did not have rashes; This is a spontaneous report from a contactable Other HCP reporting for herself A 43-years-old female patient received bnt162b2 (BNT162B2; Lot # EH9899) vaccine , via an unspecified route of administration on 26Dec2020 10:15 at single dose for Covid-19 immunisation . Medical history included thyroid cancer from 2009 , blood calcium decreased from an unknown date , depression from an unknown date , anxiety from an unknown date. Concomitant medication included cetirizine hydrochloride (ZYRTEC) [fluoxetine (FLUOXETINE), calcium carbonate, colecalciferol, menaquinone (VITAMIN K2 + VITAMIN D3 + CALCIUM), calcium carbonate (TUMS) vitamin C (VITAMIN C) , vitamin D2 (VITAMIN D2), levothyroxine sodium (SYNTHROID). On 26Dec2020, about thirty minutes after receiving the vaccine the patient suddenly felt there was something hot going through her body it made it hard to breathe , felt like a rush of hot and felt horrible , her heart rate and BP were high, she said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot. , she looked pale, and did not have rashes. The patient believed she was having an allergic reaction and gave a shot of epinephrine before going to ER. The doctors told her that her oxygen was fine (SatO2: 98%) and therefore she was not having an allergic reaction. She felt like she had trouble breathing. Her heart rate would go up to 120 to 150. Her blood pressure was high. She also received a shot of lorazepam (ATIVAN) at about 15:30 on 26Dec2020. She went bed and woke up on 27Dec2020, she had fever at 99.4�F and had nausea. The outcome of the reported events was unknown. The patient stated this was a terrible experience and she felt like she was going to die. Also she is not going to receive the second shot of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/26/2020,0.0,UNK,ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ; VITAMIN K2 + VITAMIN D3 + CALCIUM; TUMS [CALCIUM CARBONATE]; VITAMIN C [ASCORBIC ACID]; VITAMIN D2; SYNTHROID,,Medical History/Concurrent Conditions: Anxiety; Calcium low; Depression; Thyroid cancer,,,"['Blood pressure measurement', 'Body temperature', 'Computerised tomogram', 'Dyspnoea', 'Feeling abnormal', 'Feeling hot', 'Heart rate', 'Heart rate increased', 'Hypertension', 'Malaise', 'Nausea', 'Pallor', 'Pyrexia']",UNK,PFIZER\BIONTECH, 920126,,,U,"tested positive for COVID-19; was given the first COVID-19 dose. After some time, the employee got symptomatic and was tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of bnt162b2, via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient who is employed in a hospital tested negative for COVID-19 then was given the first COVID-19 dose. After some time, the patient got symptomatic and was tested positive for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported information is limited. The case will be reassessed upon receipt of follow up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 920127,PA,36.0,F,"Angioedema of lips, throat, eyes, hands. Flushing of hands; Angioedema of lips, throat, eyes, hands. Flushing of hands; Dizziness; Fatigue; Legs became heavy; Joint stiffness of hands; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJ 1685), intramuscular on the left arm on 23Dec2020 at 06:30 AM in a hospital at a single dose for COVID-19 immunization. Medical history included known allergies of seasonal allergies, cats, and metals; migraines, chronic idiopathic urticaria, and angioedema. The patient was not pregnant and did not have any other vaccine in four weeks. The patient did not have COVID prior to the vaccination and did not test positive to COVID post vaccination (also reported as not been tested for COVID-19 after the vaccination). Concomitant medication included propranolol, cetirizine hydrochloride (ZYRTEC), and sertraline (reported as other medications in two weeks). On 23Dec2020 at 06:45 AM, the patient experienced immediate symptoms of angioedema of lips, throat, eyes, hands; flushing of hands, dizziness, fatigue, legs became heavy, and joint stiffness of hands. She was monitored by colleagues for an hour, prescription for Epi pen refilled, and available angioedema and fatigue persisted for three days. It was reported that the patient was not treated for the adverse events but it was also reported that the AE treatment also included X-ray and antibiotic. Outcome of the events was recovered in Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of immediate symptoms of angioedema of lips, throat, eyes, hands, flushing of hands, dizziness, fatigue, legs became heavy, and joint stiffness of hands cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,; ZYRTEC [CETIRIZINE HYDROCHLORIDE];,,Medical History/Concurrent Conditions: Allergy to animal; Allergy to metals; Angioedema; Chronic idiopathic urticaria; Migraine; Seasonal allergy,,,"['Angioedema', 'Condition aggravated', 'Dizziness', 'Fatigue', 'Flushing', 'Immediate post-injection reaction', 'Joint stiffness', 'Limb discomfort', 'X-ray']",UNK,PFIZER\BIONTECH,OT 920128,MD,33.0,F,"tachycardia; dizziness; throat swelling; blotches on chest; palpitations; chest tightness/had residual mild chest discomfort and noticed 2 blotches on chest in car; metallic taste in mouth; This is a spontaneous report from a contactable physician (patient). A 33-year-old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) via Intramuscular on 28Dec2020 12:30 PM at single dose in the arm left for COVID-19 immunisation. Medical history included Bee venom (anaphylaxis), hereditary fructose intolerance (HFI, HFI as above but no previous issues with sucrose containing vaccines) and Known allergies: Bee venom (anaphylaxis). Concomitant medications included Linaclotide, Adderall, polyethylene glycol 3350. Roughly 5-7 minutes after injection, the patient experienced palpitations, chest tightness, and metallic taste in mouth - sensations mostly subsided after another 5 minutes so did not report. Left center after 30 mins, the patient had residual mild chest discomfort and noticed 2 blotches on chest in car. Drove home - on the way at 13: 15 (45 mins post vaccine), developed throat swelling, severe chest tightness, tachycardia (HR 130s), and dizziness. Severe symptoms (throat swelling particularly) subsided after 5 minutes but other symptoms persisted for another hour. Used albuterol, had epi pen ready but didn't use. Now 3 hours out, feeling close to baseline. The patient underwent lab tests, which included Covid test post vaccination with Negative result in Dec2020. The patient received treatment for events, which included Albuterol. Outcome of events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,; ADDERALL; POLYETHYLENE GLYCOL 3350,,Medical History/Concurrent Conditions: Allergy to venom; Anaphylactic reaction to venom; Hereditary fructose intolerance (HFI as above but no previous issues with sucrose containing vaccines),,,"['Chest discomfort', 'Dizziness', 'Dysgeusia', 'Heart rate', 'Palpitations', 'Pharyngeal swelling', 'Rash macular', 'SARS-CoV-2 test', 'Tachycardia']",1,PFIZER\BIONTECH,OT 920129,IL,37.0,F,"Painful, swollen lymph nodes in L chest; Painful, swollen lymph nodes in L chest; arm pit, muscle aches; arm pit, muscle aches; This is a spontaneous report from a contactable nurse (patient) reporting for herself. A 37-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0140), via an unspecified route of administration at left arm on 24Dec2020 09:30 at single dose for COVID-19 immunization at a hospital. The patient's medical history included hypertension, depression and anxiety. No known allergies to medications, food, or other products. Concomitant medication included alprazolam (XANAX), diclofenac (VOLTAREN), bupropion hydrochloride (WELLBUTRIN XL), amlodipine besilate (NORVASC), and diphenhydramine hydrochloride (BENADRYL). No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 post the vaccination. On 25Dec2020 05:00, the patient experienced painful, swollen lymph nodes in left (L) chest, and arm pit, muscle aches. No treatment was taken for the above events. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,PVT,XANAX; VOLTAREN [DICLOFENAC]; WELLBUTRIN XL; NORVASC; BENADRYL,,Medical History/Concurrent Conditions: Anxiety; Depression; Hypertension,,,"['Axillary pain', 'Lymph node pain', 'Lymphadenopathy', 'Myalgia']",1,PFIZER\BIONTECH, 920130,CA,40.0,F,"Angioedema; This is a spontaneous report from a contactable Other Health Professional (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL1284, intramuscular in the right arm (also reported as right shoulder), first dose on 22Dec2020 00:30 at a single dose for Covid-19 immunization. The patient's relevant medical history included severe reaction to some animal dander and pollen, severe reactions to poison oak, possible drug induced reactions (unspecified) post C-section, mild rash with influenza vaccine this year (2020) (with no other hx of adverse reaction to a vaccine); had allergies to pollen, mold, some animals. The patient previously took influenza vaccine (split virion, inactivated) and experienced rash. The patient had no covid prior vaccination nor was she tested post vaccination. Adverse event reported was angioedema on 24Dec2020 with outcome of recovering. Systems started appearing on 23Dec2020 evening with slight rash and fluid collection under right eye. Developed more rash on 24Dec2020. In the evening to early morning of 25Dec2020, symptoms worsened significantly. Rapid swelling to face occurred. Swelling was concentrated around eyes and cheeks the most. Both right and left side of the face and neck were affected. However, the right side face had a more pronounced reaction. MD ordered oral prednisone and Benadryl as treatment plan. Also, ordered episode-pen for a worst case scenario. Symptoms have been improving under treatment but still persist some. The events were reported as non-serious. The adverse event start date was 24Dec2020 (as reported). The event resulted in doctor or other healthcare professional office/clinic visit.; Sender's Comments: There is a reasonable possibility that the event angioedema was related to BNT162b2 based on known drug safety profile and temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/24/2020,2.0,PVT,,,Medical History/Concurrent Conditions: Allergy to animal; Allergy to animal dander; Allergy to molds; C-section; Poison oak rash; Pollen allergy,,,"['Angioedema', 'Periorbital oedema', 'Periorbital swelling', 'Rash', 'Swelling', 'Swelling face']",1,PFIZER\BIONTECH,OT 920131,NY,59.0,F,"got a mild generalized headache; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received bnt162b2 (lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration on the right deltoid on 17Dec2020 at 11:00 at a single dose for COVID-19 immunization. Medical history included ongoing migraine headache - stated she was diagnosed with migraines at 12 or 13 years old. There were no concomitant medications. The patient previously received influenza vaccine in Sep2020 for immunization. The patient got a mild generalized headache on 18Dec2020 and still has a headache after all these days. The patient received the COVID-19 Vaccine at the hospital where she works on 17Dec2020 at 11:00AM. She said she went to Pfizer's website for the COVID-19 Vaccine, and the Pfizer website said a headache that develops after receiving the COVID-19 vaccine lasts a few days. She said no matter what medication she is using for her headache, the medication is not working, and she still has the headache. She stated she went to her employer's employee health department, and the employee health department had no information to give her about the COVID-19 Vaccine side effects and what to do about the side effects. Reported the COVID-19 Vaccine was offered as an elective vaccine at the hospital where she works, saying the hospital offered the COVID-19 Vaccine to all its employees. As for treatment, she has taken only over-the counter products to treat her headache. She said she has been taking Tylenol 500 mg caplets, UPC Number: Unknown, Lot Number: PFA044, and Expiration Date: Mar2023. She said she has been taking 2 caplets of Tylenol 500 mg almost daily to see if she can get the edge off of her headache. She said she keeps trying the Tylenol hoping the Tylenol will one day help her headache. She clarified that on most days she is taking 2 Tylenol 500mg caplets once a day, but there have been a couple days where she took 2 Tylenol 500mg caplets twice during the day. Reported she also tried (pharmacy name) brand Migraine Relief Caplets. Reported the headaches she is experiencing now are not like the headaches she has had prior to getting the COVID-19 Vaccine. She said she goes to a neurologist for her migraine headaches, clarifying the headaches she is having now are just a generalized, dull headache. She said she can function at work with the headaches she is having now. She said the headaches are just annoying and headaches don't go away. She said the headaches are not debilitating like her migraine headaches. She said with a migraine headache, she would have to call out at work, but with the headaches she is having now, she can still function. She said the headaches she is experiencing now are not like the migraine headaches she has had prior to getting the COVID-19 Vaccine. She said she goes to a neurologist for her migraine headaches. She said the headaches she is having now are just a generalized, dull headache, and she can function at work. She said the headaches are just annoying, and don't go away. She said the headaches are not debilitating like her migraine headaches. She said with a migraine headache, she would have to call out at work, but with the headaches she is having now, she can still function. The event had not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/18/2020,1.0,PVT,,Migraine headache,,,,['Headache'],UNK,PFIZER\BIONTECH, 920132,,,M,"Throat swelling; Dizziness; This is a spontaneous report from a non-contactable other healthcare professional (HCP). A male patient of unspecified age received the first dose of bnt162b2 (lot number: EL1284), intramuscularly on the left arm on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced throat swelling and dizziness on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Dizziness', 'Pharyngeal swelling']",1,PFIZER\BIONTECH,OT 920133,AZ,51.0,F,"chest flushing; Racing heart rate; This is a spontaneous report from a contactable nurse (patient). A 51-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in the left arm on 24Dec2020 11:30 at a single dose for COVID-19 immunization. The patient has no medical history. Concomitant medication included ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, lysine hydrochloride, magnesium oxide heavy, manganese sulfate monohydrate, nicotinamide, potassium iodide, potassium sulfate, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acid succinate, zinc oxide (ONE A DAY MULTI VITAMIN & MINERALS). The patient did not receive other vaccine in four weeks. The patient previously took ephedrine and experienced allergies. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. The patient experienced chest flushing and racing heart rate on 24Dec2020 11:45. Outcome of the events was recovered in Dec2020; no treatment was needed for the events. The events was assessed as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,UNK,ONE A DAY MULTI VITAMIN & MINERALS [ASCORBIC ACID;BETACAROTENE;CALCIUM CARBONATE;CALCIUM PANTOTHENAT,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Flushing', 'Heart rate', 'Heart rate increased']",1,PFIZER\BIONTECH, 920134,,,M,"muscle aches; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced muscle aches on 26Dec2020. Outcome of the event was unknown. No follow-up attempts are possible. Information about Lot/Batch number could not be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/26/2020,7.0,UNK,,,,,,['Myalgia'],UNK,PFIZER\BIONTECH, 920135,,35.0,F,"after receiving the vaccine, she started bleeding heavily and is still currently bleeding; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) with unknown lot number and expiration date, via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient, a dispatch operator for a hospital, reported that she received the COVID vaccine a week ago on 22Dec2020. She stated that her period stopped two days prior to receiving the COVID vaccine. On 22Dec2020, after receiving the vaccine, she started bleeding heavily and is still currently bleeding. The patient wanted to know what she should do to stop the bleeding. The clinical outcome of the event was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,PVT,,,,,,['Vaginal haemorrhage'],UNK,PFIZER\BIONTECH, 920136,IL,36.0,M,"feeling rundown; feeling sick; headache; Flu like symptoms; Chills; intermittent fever/ low grade fever; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received first dose of BNT162B2 (lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration, in left arm on 20Dec2020 at single dose for COVID-19 immunization. His work was offering the vaccine to them, and he was a first responder, so he went to the hospital where they were administering it. Medical history was none. There were no concomitant medications. The patient received no other vaccines or new medications with the COVID-19 vaccine. The patient experienced headache, flu like symptoms and chills on 20Dec2020 and intermittent fever in Dec2020. The patient was a first responder who received the COVID-19 vaccine on 20Dec2020. He experienced headache, flu like symptoms and intermittent fever. The patient stated that he started feeling ""a little bit better"" for a couple of days but now he has a fever again. His work had him take a COVID-19 test on 24Dec2020 due to his symptoms and he was negative. He was asking what he should do since he is experiencing continued symptoms. The patient said he has some questions about the COVID vaccine, since he received the first dose on 20Dec2020. He said that the day he had it he had a bad headache, chills, and flu like symptoms, then the next day the same thing, then later that night a fever, then the next day a fever. He said on Christmas Eve he got a COVID test to rule it out, and the test was negative. He said he was feeling better, then on 27Dec2020 he started feeling sick with a fever, then on 28Dec2020 a low grade fever and feeling rundown. The patient said he had a nasal swab COVID-19 test done, the one with 3-5 days for results. He said that the test itself was done on 24Dec2020. He said that the temperature for his low grade fever was 100.3 degrees Fahrenheit. His question was about the side effects, since he knew that these are listed that they can be side effects. He said it just kind of worries him since he felt better and now he feels sick again and popped a fever. He said that he called his doctor, and they said they are not gonna do a second COVID test, and told him to rest. He said he doesn't think this is normal though. Treatment of the events included Ibuprofen. The patient clarified to Advil. He said he took the recommended dose of two pills, 200 mg each. Advil: UPC: Unknown, Lot: DL9107 EXP: Jan2023. He said he took the Advil maybe once a day, the first two days. The lab test included temperature: 100.3 degrees Fahrenheit in Dec2020 and COVID-19 nasal swab test: negative on 24Dec2020. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/01/2020,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'Chills', 'Fatigue', 'Headache', 'Influenza like illness', 'Malaise', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 920137,CA,66.0,F,"stomach cramps; diarrhea; chills; This is a spontaneous report from a contactable other healthcare professional. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at left arm on 24Dec2020 08:00 at single dose for Covid-19 immunization. The COVID-19 vaccine was administered in a hospital facility. Medical history included hypertension, and allergic to penicillin. The patient was not diagnosed with Covid-19 prior vaccination. Concomitant medication included amlodipine and irbesartan; both from unspecified date for unspecified indication. On 26Dec2020 22:30, the patient experienced stomach cramps, diarrhea and chills. The patient was not tested for COVID-19 post vaccination. The patient did not receive treatment due to the events. The outcome of the events stomach cramps, diarrhea and chills was recovering. The reporter considered the events non-serious; the events did not results in death, not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, not a congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/26/2020,2.0,PVT,;,,Medical History/Concurrent Conditions: Hypertension; Penicillin allergy,,,"['Abdominal pain upper', 'Chills', 'Diarrhoea']",1,PFIZER\BIONTECH,OT 920138,WI,42.0,F,"throat feeling ""hot""; tongue feeling numb and thick; tongue feeling numb and thick; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date unknown) intramuscular at left deltoid on 28Dec2020 10:00 at single dose for Covid-19 immunization. The COVID-19 vaccine was administered in the workplace clinic. Medical history included allergies to shellfish, allergies to strawberries, and environmental allergies. Concomitant medications were not reported. On 28Dec2020 10:30 am (approximately 30 min post vaccine), the patient experienced that her throat feeling ""hot"" and her tongue feeling numb and thick. The patient denied ever feeling short of breath. The patient's vital signs were recorded on 28Dec2020. The patient was not tested for COVID-19 since vaccination. The outcome of the events throat feeling ""hot"", tongue feeling numb and thick was unknown. The reporter considered the events non-serious; did not results in death, was not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, not a congenital anomaly/birth defect.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,WRK,,,Medical History/Concurrent Conditions: Environmental allergy; Fruit allergy; Shellfish allergy,,,"['Hypoaesthesia oral', 'Throat irritation', 'Tongue disorder', 'Vital signs measurement']",1,PFIZER\BIONTECH,OT 920139,NJ,65.0,F,"Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Myalgia; headache; anorexia; fatigue; weight loss; sweats; This is a spontaneous report from a contactable physician (patient). A 65 years old years female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EM9899) via an unspecified route of administration at Left arm on 22Dec2020 01:15PM at single dose for COVID-19 immunization. The patient's medical history included hypertension, body mass index (BMI) 30, hypothyroidism and Covid-19. Known allergies: penicillin, sulpha drugs, seasonal allergies. No other vaccine in four weeks. The concomitant was reported as hydrochlorothiazide, losartan potassium (HYZAAR), levothyroxine sodium (SYNTHROID), Metformin. The patient experienced pain, edema and erythema in 4 cm circumference around injection site myalgia, headache, anorexia, fatigue, weight loss, sweats, all started from 24Dec2020. No treatment received for events. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/24/2020,2.0,PVT,HYZAAR; SYNTHROID;,,"Medical History/Concurrent Conditions: Body mass index (30); COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?:Yes); Hypertension; Hypothyroidism; Penicillin allergy; Seasonal allergy; Sulfonamide allergy",,,"['Decreased appetite', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Vaccination site erythema', 'Vaccination site oedema', 'Vaccination site pain', 'Weight', 'Weight decreased']",UNK,PFIZER\BIONTECH, 920140,,39.0,M,"rash on his arm/has grown and was now a little bit itchy; This is a spontaneous report from a contactable Physician (patient). A 39-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiry date unknown) intramuscular at right arm on 20Dec2020 around 09:30 at single dose for Covid-19 vaccination. The patient's medical history and concomitant medications were none. The patient received Covid 19 vaccine 8 days ago (20Dec2020 around 09:30) and 5 days ago (Dec2020) he noticed a rash on his arm. The patient informed that he was not even sure if this was about the COVID-19 vaccine or if he has just associated it with it, but the rash has grown and was now a little bit itchy (Dec2020). The patient clarified that his first dose of the COVID-19 vaccine was on 20Dec2020 and he had onset of rash about 23Dec2020 or 24Dec2020, he was not exactly sure. The outcome of the event rash on his arm/has grown and was now a little bit itchy was not recovered. The reporter causality was unknown, with the information he has obtained and the conversation he just had with the inbound transfer agent it seemed a very low, slight likelihood that there was a causality relationship.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/01/2020,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['Rash pruritic'],1,PFIZER\BIONTECH,OT 920141,MO,,F,"the injection site become red and sore; the injection site become red and sore; This is a spontaneous report from a contactable Other HCP (patient). A female patient of an unspecified age received the first dose of BNT162B2 (batch/lot number and expiration date not provided), via an unspecified route of administration, on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the vaccine on 18Dec2020 and did not initially have any side effects but yesterday(8 days after vaccination) the injection site become red and sore on an unknown date. The outcome of the events was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,,,UNK,,,,,,"['Vaccination site erythema', 'Vaccination site pain']",1,PFIZER\BIONTECH, 920142,NY,37.0,F,"tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; sinus infection; tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; Her nose being stuffed; tension headache on the back of head; her deltoid was hurting for 24 hours; active infection after getting the first dose; This is a spontaneous report from a contactable pharmacist (patient). A 37-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the right deltoid on 18Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient had active infection after getting the first dose, consult if it was still recommended to get the second dose next week or she should be delaying getting the second dose. The patient got the COVID vaccine on the 18Dec2020. Then on the 24Dec2020 she tested positive for the COVID virus. She was due to get the second vaccine on 08Jan2021. She was asking should she still get the 2nd dose of the vaccine since came up positive. The patient was having a symptom, she lost her sense of smell of 22Dec2020. She lost her sense of smell on the evening on 22Dec2020, it still had not come back at all. She did have sense of taste on the tongue. She thought it was sinus infection, because her head didn't hurt and she was not stuffed anymore. She stated that after the vaccine, she had a tension headache on the back of head, and her deltoid was hurting for 24 hours. Her headache started the same day in the evening, went on till lunch time next day. Her nose being stuffed which she thought was a sinus infection started on Tuesday 22Dec2020, it was more located in the front middle of her forehead. Her nose being stuffed which she thought was a sinus infection started on Tuesday 22Dec2020, it was more located in the front middle of her forehead. She did not have her Card to provide Lot and Expiry, it was at work at the hospital. She was administered the vaccine on the right deltoid, since she didn't want to sleep on it. Prior to vaccine she has had no positive test for Covid. Caller stated that this was super unfortunately coincidental. She had had no antibody test. She had no reactions to vaccines in the past. Test: Respiratory Panel. Result: Negative on unknown date. The outcome of events drug ineffective, COVID-19 and sinus infection was not recovered. The outcome of event tension headache and muscle pain was recovered in Dec2020. The outcome of rest events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the reported events of LOE, COVID 19 and other events, based on temporal relationship. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/01/2020,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Anosmia', 'COVID-19', 'Drug ineffective', 'Myalgia', 'Nasal congestion', 'Respiratory viral panel', 'SARS-CoV-2 test positive', 'Sinusitis', 'Tension headache']",1,PFIZER\BIONTECH, 920143,AL,60.0,F,"generally not feeling well; a low grade fever; chills; freezing; couldn't get warm; tired and run down; sleepy; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EK5730), via an unspecified route of administration on 16Dec2020 08:40 AM at right deltoid, at single dose for covid-19 immunization. Medical history included sleep disorder. Concomitant medication included alprazolam prn (as needed) for sleep, HCTZ; losartan; metoprolol; montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL). On 18Dec2020 the patient had temperature of 98.8 which is low grade fever for her because she runs low. On 18Dec2020, she experienced a low grade fever, chills and was freezing. On 18Dec2020 she had chills and couldn't get warm. She had three layers on and a heating vest. It passed and she was doing fine. Those symptoms passed, but reappeared on 26Dec2020, last Saturday. Since then, she mentioned generally not feeling well, in addition to being freezing cold and experiencing chills every day. She had been monitoring her temperatures, and had no fever. Since 26Dec2020, she had chills, couldn't get warm, and no fever. She was tired and run down. She was sleepy and usually she was very energetic. The patient asked if have heard of such experience in other people. Seriousness Criteria was reported as it was not disabling, but annoying. It was unusual. She had on a thermal shirt that she would wear for skiing and that is not normal. Then on the 26Dec2020 the chills started back again. She felt kind of tired. She didn't feel sick, but not up to snuff. No AE required emergency room/physician office. The outcome of the event fever was recovered on 19Dec2020. The outcome of the events freezing; sleepy; tired and run down was unknown. The outcome of the other events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/01/2020,,PVT,; HCTZ; ; ; SINGULAIR; XYZAL,,Medical History/Concurrent Conditions: Sleep disorder,,,"['Blood count', 'Body temperature', 'Chills', 'Fatigue', 'Feeling cold', 'Freezing phenomenon', 'Malaise', 'Pyrexia', 'Somnolence']",1,PFIZER\BIONTECH, 920144,,43.0,F,"arm pain/soreness; This is a spontaneous report from a non-contactable nurse reported for herself. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiry date unknown) via an unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain/soreness on unspecified date. The outcome of the event arm pain/soreness was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain in extremity'],UNK,PFIZER\BIONTECH, 920145,CA,44.0,F,"L armpit swollen; L armpit lymph nodes swollen; Sensation of heaviness left arm; painful scapular area; This is a spontaneous report from a contactable other health professional (patient). A 44-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/ Lot number: eh9899), intramuscularly on 22Dec2020 12:30 at single dose on left arm for COVID-19 immunization in hospital. Medical history included ongoing hypertension, allergic to shellfish. Concomitant medication within 2 weeks of vaccination included losartan, hydrochlorothiazide, vitamin C [ASCORBIC ACID], colecalciferol (VITAMIN D), zinc, paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced L armpit swollen/ L armpit lymph nodes swollen, sensation of heaviness left arm and painful scapular area from 23Dec2020 15:30. No treatment received for the adverse events. The outcome of events was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,; ; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; ; TYLENOL,Hypertension,Medical History/Concurrent Conditions: Shellfish allergy,,,"['Arthralgia', 'Limb discomfort', 'Lymphadenopathy', 'Swelling']",1,PFIZER\BIONTECH,OT 920146,CO,,F,"tested positive; tested positive; Symptoms experiencing include having no taste, smell and slight bodyache; Symptoms experiencing include having no taste, smell and slight bodyache; Symptoms experiencing include having no taste, smell and slight bodyache; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable other-healthcare professional (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive on 24Dec2020, and symptoms experiencing include having no taste, smell and slight body ache in Dec2020. The patient asked if she could get the second dose. The outcome of the events was unknown. Information about the Lot/batch number has been requested.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the COVID-19, with symptoms of having no taste, smell and slight body ache, and vaccination with BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/01/2020,,UNK,,,,,,"['Ageusia', 'Anosmia', 'Pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 920147,AZ,42.0,F,"Nausea; vomiting; pain at injection site with paresthesias in the lower arm; pain at injection site with paresthesias in the lower arm; neck pain on the injection side; severe fatigue; myalgia; Fever; chills; SOB on exertion; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old female patient received 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), via an unspecified route of administration at arm left, on 18Dec2020 at 02:30 PM, at single dose, for COVID-19 immunisation. Medical history included hypertension, obesity, mood disorder, latex allergy. Patient did not experience COVID-19 before vaccination. Concomitant medications included trazodone (unknown manufacturer), escitalopram (unknown manufacturer). On 18Dec2020 at 10:00 PM the patient experienced nausea with outcome of recovering, vomiting with outcome of recovering, pain at injection site with paresthesias with outcome of recovering, neck pain on the injection side with outcome of recovering, severe fatigue with outcome of recovering, myalgia with outcome of recovering, fever with outcome of recovering, chills with outcome of recovering, shortness of breath (SOB) on exertion with outcome of recovering. The patient underwent lab tests and procedures which included COVID-19 PCR test (nasal swab): negative on 25Dec2020. No therapeutic measures were taken as a result of the events. The events were considered non serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,WRK,;,,Medical History/Concurrent Conditions: Hypertension; Latex allergy; Mood disorder; Obesity,,,"['Chills', 'Dyspnoea exertional', 'Fatigue', 'Myalgia', 'Nausea', 'Neck pain', 'Pyrexia', 'SARS-CoV-2 test', 'Vaccination site pain', 'Vaccination site paraesthesia', 'Vomiting']",1,PFIZER\BIONTECH, 920148,AZ,61.0,F,"aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was freezing/chills; cold was worse; couldn't get comfortable; started feeling bad when she went to bed; This is a spontaneous report from a contactable consumer (patient's husband). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 27Dec2020 at 12:45 on Left Upper Arm at single dose for COVID-19 immunization in hospital. No additional vaccines administered on same date of bnt162b2. The patient medical history included she may be a little overweight, but she was not obese. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium (SYNTHROID), lubiprostone (AMITIZA) for stomach. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the flu shot (influenza vaccine) in the past for immunization and got sick once afterward, she was not sure if it was food poisoning or the flu vaccine, she didn't get one this year. Patient's husband reported that patient got the vaccine yesterday (27Dec2020). She felt fine all day but started feeling bad when she went to bed on 27Dec2020. She was experiencing aches, pains hot flashes and a little fever a little over 100. She had a miserable night. She had body aches and pains, hot flashes and a little fever started around one in the morning of 28Dec2020. The fever was a little over one hundred. It looked like she what she got was normal side effects. The reporter didn't know how long approximately and how high her fever could get before he called the doctor. She had started to feel better on 28Dec2020. Then she was down again. She didn't feel great when she went to bed and then was up from 1AM to 2AM until now (28Dec2020). From 1AM or 2AM until 7AM or 8AM of 28Dec2020 it was the worse with bad aches and pains. She couldn't get comfortable. Alternating between fever and chills. Around 8AM to 9AM it started to get less and the aches started to get less. She didn't have a fever and he had checked 4 or 5 times. Around 2:00PM on 28Dec2020 she had the fever of a little over 100. The hot flashes were moderate to severe. The cold was worse and she was freezing in the middle of the night on 28Dec2020. He gave her heating pads and blankets and she was still freezing. Reporter thought the second shot would be worse with reactions. She was concerned about getting the second shot. No event required a visit to Emergency Room or Physician Office. No Investigation Assessment provided. The outcome of the events was unknown. This report was reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,12/27/2020,0.0,PVT,WELLBUTRIN; SYNTHROID; AMITIZA,,"Medical History/Concurrent Conditions: Overweight (She may be a little overweight, but she is not obese)",,,"['Body temperature', 'Chills', 'Discomfort', 'Feeling abnormal', 'Hot flush', 'Nasopharyngitis', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 920149,IA,,U,"Positive rapid test and PCR test after 1st vaccination; Positive rapid test and PCR test after 1st vaccination; This is a spontaneous report from a contactable nurse reporting for her/himself. A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on 15Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive on 27Dec2020 on a rapid test and on 28Dec2020 on a respiratory panel by PCR. Next dose was scheduled on 05Jan2021. The information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Positive rapid test and PCR test based on the known safety profile. However the short duration of 12 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/15/2020,12/27/2020,12.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 920150,MA,42.0,F,"Severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain; tiredness; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via an unspecified route of administration in left arm on 17Dec2020 07:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. There was no medical history. Concomitant medication in two weeks included vitamin d3, cyanocobalamin (B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain and tiredness on 17Dec2020 at time of 09:00 AM. No treatment received for these events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,VITAMIN D3; B12 [CYANOCOBALAMIN],,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Other medical history: None",,,"['Ageusia', 'Arthralgia', 'Fatigue', 'Pain in extremity', 'Taste disorder']",1,PFIZER\BIONTECH, 920151,NY,,F,"tested positive for coronavirus; tested positive for coronavirus; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for coronavirus on 24Dec2020. The patient worked in a hospital. She got the first dose of Pfizer coronavirus vaccine on Tuesday, 22Dec2020. She tested positive for coronavirus on Thursday 24Dec2020 after exposure to patients and staff. She had mild symptoms. Her 2nd dose was scheduled for 12Jan2021. The patient was inquiry whether she should receive it, or should she take an antibody test first, but it would be less than 3 weeks from the onset of illness. The outcome of event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event tested positive for coronavirus based on the known safety profile. However the short duration of 2 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/24/2020,2.0,UNK,,,,,,"['Coronavirus test positive', 'Illness', 'Occupational exposure to SARS-CoV-2']",1,PFIZER\BIONTECH, 920152,ID,35.0,F,"I have had mild tenderness and what I would describe as a burning sensation around the T1-T3 dermatome area, on the same side as my injection, beginning approximately 1-2 days post vaccination.; I have had mild tenderness and what I would describe as a burning sensation around the T1-T3 dermatome area, on the same side as my injection, beginning approximately 1-2 days post vaccination.; feeling like prodromal shingles pain though she never personally had shingles; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 35-year-old female patient received first dose of BNT162B2, intramuscular (right arm), on 18Dec2020 at 11:00, at a single dose, for COVID-19 vaccination. Medical history included allergies to penicillin. The patient's concomitant medications were not reported. On 20Dec2020, the patient had mild tenderness and would describe as a burning sensation around the T1-T3 dermatome area, on the same side of her injection, beginning approximately 1-2 days post vaccination. She was feeling like prodromal shingles pain though she never had shingles. Patient is currently on 10th day post vaccination and continues to have this sensation and mild tenderness but have yet to develop any shingles rash. The patient did not receive treatment for events ""I have had mild tenderness and what I would describe as a burning sensation around the T1-T3 dermatome area, on the same side as my injection, beginning approximately 1-2 days post vaccination."" Outcome of the event pain was unknown, while for the remaining events was recovering. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/20/2020,2.0,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Burning sensation', 'Pain', 'Tenderness']",1,PFIZER\BIONTECH,OT 920153,TX,32.0,F,"Fever 101.5; body aches; chills; headache; This is a spontaneous report from a contactable other health professional (patient). A 32-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on 27Dec2020 08:45 at single dose at right arm for COVID-19 immunization. Medical history reported as none, no Allergies to medications, food, or other products. Concomitant medication was none, the patient did not receive any medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Dec2020 21: 30 (09:30 PM), the patient experienced fever 101.5, body aches, chills, headache. Treatment received for the adverse events included Tylenol. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'Chills', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,OT 920154,,22.0,F,"pain between her right scapula and spine; pain between her right scapula and spine; This is a spontaneous report from a contactable nurse (patient herself). A 22-year-old female patient started to receive BNT162B2 (lot number: EJ1685; expiry date unknown) intramuscular (right arm), on 28Dec2020, at a single dose, for COVID-19 vaccine injection/ vaccination. The patient's medical history and concomitant medications were not reported. This nurse was administered her first dose of Pfizer COVID-19 Vaccine on 28Dec2020, in the morning. Her first concern was that the nurse put the COVID-19 Vaccine injection really low into her right arm, but believes it did go into the muscle. She was concerned that it did not really go into her muscle but the more she has been lifting her arm and seeing where the shot was administered and where her muscle in her arm ends she believes it did go into the muscle. She contacted her primary care provider today because about 30 minutes to 1 hour after she was administered the COVID-19 vaccine injection on 28Dec2020 she had a pain in between her right scapula and spine, which is the side she got her vaccine on. She also reported that her right arm does not hurt at all, she has no pain at injection site for COVID-19 Vaccine which she finds really weird. She also felt the pain if she hunches her shoulders backwards, sits up really straight, crosses her arms or hunches forward; she does not really feel it if she takes a deep breath. She was wondering if these events are normal or expected or serious. Outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['Arthralgia', 'Spinal pain']",UNK,PFIZER\BIONTECH,OT 920155,,39.0,F,"Left with nasty scab; Hand was wet from where she had scratched/busted open water blisters on her hand; A rash and hives on that hand/rash unilaterally from the vaccination-side armpit to her breast and collar bone; A rash and hives on that hand; This is a spontaneous report from a contactable other health professional (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at 14:00 at single dose for COVID-19 immunization. The patient medical history included breast cancer survivor, radiotherapy, psoriasis, pre-diabetic, hypertension, hypercholesterolemia and chronic obstructive pulmonary disease (COPD), all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient reported that: "" on 23Dec2020 at 6:00, she woke up and her hand was wet from where she had scratched/busted open water blisters on her hand (same arm that she received the vaccine in). She also reported a rash and hives on that hand, and a rash unilaterally from the vaccination-side armpit to her breast and collar bone but nothing at injection site. She stated she took BENADRYL, symptoms subsided until BENADRYL wore off, then resurfaced, took more BENADRYL, then symptoms resolved. Symptoms lasted about 24 hours post injection, patient was left with a ""nasty scab"" on her hand from where she scratched the water blisters"". The patient outcome of the events was recovered except for the ""nasty scab"" whose outcome was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,UNK,,,Medical History/Concurrent Conditions: Breast cancer (Breast cancer survivor (treated with radiation therapy)); COPD (COPD radiation from cancer); Hypercholesterolemia; Hypertension; Pre-diabetic; Psoriasis; Radiation therapy (Breast cancer survivor (treated with radiation therapy)),,,"['Blister', 'Rash', 'Scab', 'Urticaria']",1,PFIZER\BIONTECH, 920156,,,U,"tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable Pharmacist reported similar events for 2 patients. This is the first of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller is a pharmacist asked if there is a contraindication for administering antibody therapy to a person after they have received the first dose of the covid vaccine. He reported that there are 2 patients that received the covid vaccine the week of 14Dec and subsequently tested positive for covid on the 23rd and 24th of December. He was trying to determine the safety of administering antibody therapy for those patients even though they already got the first vaccine dose. He reported this question has some urgency and needed the information within 48 hours. Attempted to warm transfer but caller reported that he does not have any patient specific information or identifiers at this time. Escalating Urgently for additional research. Outcome of event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the event ""tested positive for COVID"" and vaccination with BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-2020516661 same reporter/ drug/ AE, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/14/2020,12/01/2020,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 920157,AR,,M,"meningitis; headache; fever; weakness; rash; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (lot/batch number and expiration date not provided), via an unspecified route of administration, on 16Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the Pfizer-BioNTech COVID-19 Vaccine on 16Dec2020, he experienced headache, fever, weakness and rash; went to the ER and after testing blood work and suspecting of meningitis. They did a spinal tap. Test came out negative for Flu and COVID; was told the rash could be due to a drug reaction and they attributed side effects to a generic bactrim, so he stopped taking all medications. If he continues to have issues the primary concern is whether he should get the second dose of the COVID-19 vaccine or not. The outcome of the events were unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,,,UNK,,,,,,"['Asthenia', 'Blood test abnormal', 'Headache', 'Influenza virus test negative', 'Lumbar puncture', 'Meningitis', 'Pyrexia', 'Rash', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH, 920158,NM,33.0,M,"soreness in left arm the following day along with fatigue and body aches; soreness in left arm the following day along with fatigue and body aches; soreness in left arm the following day along with fatigue and body aches; This is a spontaneous report from contactable other healthcare professional. A 33-year-old male patient received first dose of BNT162B2 (lot number: EH9899; expiry date: unknown) intramuscular (left arm), on 23Dec2020 at 14:00, at a single dose, for COVID-19 vaccination. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The patient experienced soreness in left arm the following day (24Dec2020) at 8:00 a.m. along with fatigue and body aches. The patient did not receive treatment for the events. The patient recovered from the events on an unspecified date in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PUB,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Fatigue', 'Pain', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 920159,MO,52.0,F,"Tingling in throat; throat swelling; This is a spontaneous report from a contactable nurse (patient herself). A 52-year-old female patient received first dose of BNT162B2 (lot number: EH9899; expiry date: 31Mar2021), via an unspecified route of administration, on 28Dec2020 10:00 am (left arm), at a single dose, for COVID-19 vaccination. Relevant medical history included hypertension and seasonal allergies. Concomitant medication included levocetirizine dihydrochloride (XYZAL). The patient previously took losartan, sulfa, ultram, morphine, codiene, and lisinopril and experienced allergies. On 28Dec2020, at 10:15 a.m., the patient experienced tingling in throat and throat swelling. The patient received Benadryl as treatment for the events. Outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,XYZAL,,Medical History/Concurrent Conditions: Hypertension; Seasonal allergy; Sulfonamide allergy,,,"['Pharyngeal paraesthesia', 'Pharyngeal swelling']",1,PFIZER\BIONTECH, 920160,TN,34.0,F,"Vomiting; chills; Diarrhea; Nausea; fatigue; This is a spontaneous report from a contactable nurse(patient). A 34-year-old female patient received first dose BNT162B2 (lot number: EL0140), via an unspecified route of administration on 28Dec2020 07:00 at 34 years old at single dose at Left arm for COVID-19 immunization. Medical history included Migraines, asthma, chronic bronchitis, PCOS, Allergies to Penicillin. The concomitant medications were biotin, bifidobacterium infantis, lactobacillus acidophilus(PROBIOTIC), Multivitamin, vitex agnus castus. The patient previously took codeine and experienced allergies. Nausea and fatigue beginning about four hours after administration on 28Dec2020 11:00. Diarrhea beginning about six hours after administration on 28Dec2020 13:00. Vomiting and chills beginning about eight hours after administration on 28Dec2020 15:00. There was no treatment received for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was Recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,WRK,; PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]; VITEX AGNUS CASTUS,,Medical History/Concurrent Conditions: Asthma; Chronic bronchitis; Migraine; Penicillin allergy; Polycystic ovarian syndrome,,,"['Chills', 'Diarrhoea', 'Fatigue', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH, 920161,TX,28.0,F,"Body aches; chills; redness and pain in injection site; redness and pain in injection site; headache; This is a spontaneous report from a contactable other hcp (patient). A 28-year-old female patient received bnt162b2 (lot number: EL0140), intramuscularly at arm right, first dose on 27Dec2020 10:15, at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS) and hypertension from an unknown date. The patient was not pregnant. No known drug allergies. Concomitant medication included losartan, and metformin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced body aches, chills, redness and pain in injection site, headache on 27Dec2020 12:00. Therapeutic measures were taken as a result of body aches, chills, redness and pain in injection site, headache, treatment included Tylenol. The events were reported as non-serious. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,PVT,;,,Medical History/Concurrent Conditions: Hypertension; Polycystic ovarian syndrome,,,"['Chills', 'Headache', 'Pain', 'Vaccination site erythema', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 920162,NJ,49.0,F,"High fevers (103/104 degree F) with chills for five days followed by low fevers ( upto 101) for another six days and still ongoing; High fevers (103/104 degree F) with chills for five days followed by low fevers ( upto 101) for another six days and still ongoing; headaches; fatigue; This is a spontaneous report from a contactable physician, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 18Dec2020 at 15:15 (at 49-years-old) as a single dose for COVID-19 immunization. Medical history included severe iron deficiency, hypothyroidism, osteoporosis, and low baseline IgM antibodies levels (unknown cause). The patient did not have any allergies to medications, food, or other products. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), and biotin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Dec2020 at 18:00, the patient experienced high fevers (103/104 degrees Fahrenheit) with chills for five days followed by low fevers (up to 101 degrees Fahrenheit) for another six days, headaches, and fatigue; all reported as non-serious. On 24Dec2020, the patient had a post vaccination nasal swab rapid antigen test and SARS-CoV-2 PCR test with negative results. The patient took paracetamol (TYLENOL) and ibuprofen (ADVIL) for treatment for the events. The clinical outcomes of the fever, chills, headaches, and fatigue were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of high fevers with chills. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/19/2020,1.0,PVT,; ; ;,,Medical History/Concurrent Conditions: Hypothyroidism; IgM decreased; Iron deficiency; Osteoporosis,,,"['Chills', 'Fatigue', 'Headache', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 920163,,45.0,M,"mild fever; body and joint aches; body and joint aches; This is a spontaneous report from a non-contactable physician. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, an unspecified route of administration, from 26Dec2020 at a single dose, for COVID-19 immunization. Medical history included penicillin allergies. The patient's concomitant medications were not reported. On 26Dec2020 20:00, the patient experienced mild fever and ""body and joint aches"", lasted for 24 hours. Therapeutic measures were taken as a result of the events included tylenol and advil. The outcome of events was recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,WRK,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Arthralgia', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 920164,,,F,"tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable other healthcare provider. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 21Dec2020 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient said that she received the Pfizer-BioNTech Covid-19 Vaccine last Tuesday, 21Dec2020, then tested positive for Covid on 26Dec2020. She said the symptoms started on 24Dec2020. Now, she wants to know if it is still okay to get the 2nd dose of the vaccine on the scheduled date. The outcome of events was unknown. Information about Lot/Batch number has been requested.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the event ""tested positive for COVID"" and vaccination with BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/26/2020,5.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 920165,,,F,"had an inflamed lymph node after the vaccine; This is a spontaneous report from a contactable consumer (Pfizer colleague). A female patient of an unspecified age received bnt162b2 (BNT162B2; solution for injection; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at single dose for Covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The reporter stated that her family friend reported that she had an inflamed lymph node after the vaccine. She said that she already did the vsafe but didn't say anything about the reaction to the vaccine. The patient inquired if there was another website that she needs to report to which the reporter replied that VAERS is the correct place to report. The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Lymphadenitis'],1,PFIZER\BIONTECH, 920166,,46.0,M,"tachycardia(HR-90's to 130) for 3 days; injection site discomfort; myalgias; fatigue; This is a spontaneous report from a non-contactable physician (patient). A 46-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscular at right arm on 21Dec2020 09:30 at single dose for COVID-19 immunization at a hospital. The patient's relevant medical history was reported as none, other medical history was none. No allergies to medications, food, or other products. Concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination. It was reported that the patient got the vaccine on Monday (21Dec2020). On 21Dec2020 13:00, the main symptom that he was having was tachycardia (HR-90's to 130) for 3 days. Only other symptoms were injection site discomfort, myalgias and fatigue. The above events resulted in doctor or other healthcare professional office/clinic visit. No treatment was taken for the above events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,PVT,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none, Comment: Other Medical history: None",,,"['Fatigue', 'Heart rate', 'Myalgia', 'Tachycardia', 'Vaccination site discomfort']",1,PFIZER\BIONTECH,OT 920167,IL,36.0,F,"runny nose that had bloody discharge; runny nose that had bloody discharge; The mother was 23 weeks pregnant at the onset of the event; pregnancy; pregnancy; This is a spontaneous report from a non-contactable physician (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Not available/provided to reporter at the time of report completion) via an unspecified route of administration on 26Dec2020 13:30 on right arm at a single dose for COVID-19 immunization. The patient was allergies for adhesives. The patient is pregnant at the time of vaccination. The mother was 23 weeks pregnant at the onset of the event. The mother was due to deliver on 23Apr2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included acetylsalicylic acid (ASPIRIN 81) at 81mg. The patient experienced runny nose that had bloody discharge on 27Dec2020. No treatment received for the event. The outcome of the event was recovered in Dec2020. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,PVT,ASPIRIN 81,,Medical History/Concurrent Conditions: Dermatitis contact,,,"['Epistaxis', 'Maternal exposure during pregnancy', 'Off label use', 'Product use issue', 'Rhinorrhoea']",1,PFIZER\BIONTECH, 920168,MO,49.0,F,"difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; axillary lymph node swelling; wrist pain and swelling/joint pain; wrist pain and swelling; muscle and joint pain; skin pain; kidney and liver pain; kidney and liver pain; dizziness; nausea; weakness; fatigue; chilling; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in right arm on 22Dec2020 14:30 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR). The patient experienced Injection site pain and swelling, axillary lymph node swelling, wrist pain and swelling, muscle and joint pain, skin pain, kidney and liver pain, dizziness, nausea, weakness, fatigue, chilling, difficulty thinking, brain fog on 23Dec2020 01:15. Symptoms lasting x 6 days. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was reported as recovering. Information about lot/batch number are requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the difficulty thinking, brain fog and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,ADVAIR,,Medical History/Concurrent Conditions: Asthma,,,"['Arthralgia', 'Asthenia', 'Chills', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Hepatic pain', 'Injection site pain', 'Injection site swelling', 'Joint swelling', 'Lymphadenopathy', 'Mental impairment', 'Myalgia', 'Nausea', 'Pain of skin', 'Renal pain']",1,PFIZER\BIONTECH,OT 920169,GA,45.0,F,"itchy flushed skin with a rash; itchy flushed skin with a rash; itchy flushed skin with a rash; This is a spontaneous report from a contactable healthcare professional. A 45-year-old female patient received bnt162b2 (BNT162B2; reported as Pfizer-Bio-Tech COVID-19 Vaccine; lot number: EH9899; expiration date: unknown), intramuscular left arm on 16Dec2020 10:45 (also reported as 10:50 AM) at single dose for Covid-19 vaccination. The patient's medical history and concomitant medications were not reported. It was unknown if the patient has allergies to medications, food, or other products. It was reported that the patient was given vaccine at 10:50 am and 10 minutes after receiving the vaccine individual developed itchy flushed skin with a rash. She was given Benadryl 50 mg IM (intramuscular) in Right arm at 11:00 am. 11:37 am the itchy skin was less intensified, and vitals were stable. The patient went home with her husband. The event was considered as non-serious, was not life-threatening, did not caused/prolonged hospitalization, did not cause congenital anomaly/birth defect and did not resulted to death. The patient received the COVID-19 vaccine in the Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patent had any other medications the patient received within 2 weeks of vaccination. It was unknown if the patient diagnosed with COVID-19 prior to vaccination and if the patient been tested for COVID-19 since the vaccination. The outcome of the event itchy skin was recovering while the outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/16/2020,0.0,PUB,,,,,,"['Flushing', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH,OT 920170,ID,66.0,F,"difficulty communicating, difficulty thinking; difficulty communicating, difficulty thinking; difficulty communicating, difficulty thinking/She could not talk; her tongue was acting like it was swollen; Headache; Dizziness/she got really dizzy; This is a spontaneous report from a contactable consumer (patient). A 66 years old years female patient (no pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EJ1685, Expiry Date: Mar2021) via intramuscular at right arm on 22Dec2020 16:00 at single dose for preventative (COVID-19 immunization). The patient's medical history was allergic to iodine, yellow jackets, and perfumes or colognes. The concomitant was reported as none. The patient clarified that after receiving the vaccine she started with headache and then she got really dizzy. The dizziness lasted for about a day. Headache lasted for about 2 or 3 days. She had difficulty communicating with people or thinking. She could not talk, her tongue was not swollen but her tongue was acting like it was swollen. Events onset date was in Dec2020. She experiences these symptoms when she has any reaction to her allergies. Treatment included that She has been taking what she always takes for her allergies which is Tylenol for headache and Benadryl for her allergies. Her second dose was scheduled for 12Jan2021. She was asked to go to the hospital but she did not have time to go to the hospital. States she works three jobs and did not have the time. The outcome of the events was recovered completely from all side effects on Christmas day (on 25Dec2020).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/01/2020,,PVT,,,"Medical History/Concurrent Conditions: Iodine allergy (She is allergic to iodine, yellow jackets, and perfumes or colognes.); Perfume sensitivity (She is allergic to iodine, yellow jackets, and perfumes or colognes.)",,,"['Communication disorder', 'Dizziness', 'Headache', 'Speech disorder', 'Swollen tongue', 'Thinking abnormal']",1,PFIZER\BIONTECH,OT 920171,MI,50.0,F,"Sometimes her headaches are migraines; Chills; Fever; Cough; Really lazy; Body aches; Headache; Nausea; This is a spontaneous report from a contactable Registered nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: E10140), via an unspecified route of administration on 23Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included ongoing Diabetic for at least 7 years, ongoing hit in the head (She was a psych nurse and was hit in the head at work maybe a month to two months ago in 2020. She did have headaches from that incident). There were no concomitant medications. The patient experienced headache on 23Dec2020, fever on 24Dec2020 14:30, nausea on 23Dec2020, cough on 24Dec2020, really lazy on 24Dec2020, chills on 24Dec2020 14:30, body aches on 24Dec2020, sometimes her headaches were migraines on an unspecified date. Specifically, it was reported that when she first got the vaccine, she didn't have anything but a headache and a little bit of nausea. She had worked the night before and didn't sleep before the shot. So maybe that had a part in it. She was a diabetic. It was fine, and no big deal that night. Then, the next day on 24Dec2020 at 2:30 pm she woke up and she was freezing and couldn't get warm. She had chills and a fever of 102.1 on 24Dec2020. She took Tylenol, and it came down to 101 on an unspecified date in Dec2020. All weekend long, she has had a fever. It has been controlled by Tylenol. She had chills so bad she had to use her heated blanket. She has had a cough. She has been really lazy. She has had chills and body aches. She has had nausea here and there. She has had a headache. She received the vaccine on the 23Dec2020, which was Wednesday. She had to stay 15 minutes after. That is when she developed the headache and nausea. Sometimes her headaches were migraines. She developed the fever on 24Dec2020 14:30. Or noticed the fever when she woke up. Her fever was 101.2 this morning on 28Dec2020. Within the 15 minutes of getting the vaccine, she developed the nausea. It has gotten better. Her body aches are getting better. She still has chills when she is running a fever. She has gotten better overall. Thursday (24Dec2020), Friday (25Dec2020), and Saturday (26Dec2020) it was awful. Sunday (27Dec2020) the symptoms lightened up. Today (28Dec2020) she was better. She still had a headache and fever this morning, but nothing like she had been feeling. She felt like dying those days. She was a Psych nurse, and she got hit in the head. So she did get headaches from that incident. They are about the same as these headaches so she didn't know if it was related. It just went along with the flu like symptoms. But sometimes these headaches were migraines. Therapeutic measures were taken as a result of fever and chills. The outcome of the events headache, chills was not recovered. The outcome of the event really lazy was recovered on 27Dec2020. The outcome of the events fever, nausea, cough, body aches was recovering. The outcome of the event migraines was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,OTH,,Diabetic (At least 7 years); Head injury (She is a psych nurse and was hit in the head at work. She did have headaches from that incident),,,,"['Body temperature', 'Chills', 'Cough', 'Headache', 'Laziness', 'Migraine', 'Nausea', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 920172,PA,64.0,F,"rash, hives type things on face/rash on the face after the COVID vaccine; rash, hives type things on face; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; NDC/UPC/batch/lot number and expiration date were unknown), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. Concomitant medications included mometasone furoate (ASMANEX) inhaler, pramipexole, simvastatin, montelukast, and gabapentin. The patient stated that she didn't know if she was having side effects from the vaccine or not since for the last three days, she had been getting almost like a rash, hives type things on face; nowhere else, just on her face from 25Dec2020. The patient believed it just started in the last couple of days and it didn't happen right at first and wanted to know what it's from. The patient considered herself as a first responder as she worked at the court house and did protection from abuse orders for people in domestic violence situations. The patient was still experiencing the problems and seemed to happen in the afternoon, every afternoon she seemed to get it. The patient further reported that she experienced rash on the face after the COVID vaccine and it happened in the afternoon. She got the COVID (19) vaccine on Wednesday and on Friday afternoon (also reported as the ""25th, Christmas day""), she experienced rash on the face; she said it was not bad, but it happened in the afternoon. She still had it at the time of the report and it's just on her face. The patient did not receive any treatment for the events. The patient had no investigation assessment. The patient was not recovered from the events ""rash, hives type things on face/rash on the face after the COVID vaccine."" Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/25/2020,2.0,PVT,ASMANEX; ; ; ;,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Rash', 'Urticaria']",UNK,PFIZER\BIONTECH, 920173,CA,41.0,F,"nausea; diarrhea; upset stomach; This is a spontaneous report from a contactable nurse (patient herself). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EH9899, expiration date: unknown), intramuscularly on the right arm on 21Dec2020 at 07:15 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included asthma. The patient had no known allergies; no allergies to medications, food, or other products. Concomitant medications included montelukast sodium (SINGULAIR) and budesonide, formoterol fumarate (SYMBICORT). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Dec2020 at 06:00, the patient experienced nausea, diarrhea, and upset stomach, which were assessed as non-serious. The patient did not receive treatment for the adverse events. The patient was recovering from the events ""nausea, diarrhea, and upset stomach.""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/22/2020,1.0,PVT,SINGULAIR; SYMBICORT,,Medical History/Concurrent Conditions: Asthma,,,"['Abdominal discomfort', 'Diarrhoea', 'Nausea']",1,PFIZER\BIONTECH,OT 920174,PA,38.0,F,"developed 2 more of the same type of sores on inside of my cheek, in mouth; sore under top lip; headache; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 12:00 PM, at left arm, at single dose for covid-19 immunization. Medical history included hepatitis c from an unknown date and unknown if ongoing. Concomitant medication included fluoxetine hydrochloride (PROZAC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient was not pregnant at the time of vaccination. First day on 24Dec2020 the patient had headache and fatigue, some nausea. Day 3 (26Dec2020) and 4 (27Dec2020) headaches all day, mild. Day 5 (28Dec2020) developed sore under top lip and day 6 (29Dec2020) developed 2 more of the same type of sores on inside of my cheek, in mouth. No treatment was received for all events. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,PROZAC; ADDERALL,,Medical History/Concurrent Conditions: Hepatitis C,,,"['Fatigue', 'Headache', 'Lip pain', 'Nausea', 'Stomatitis']",1,PFIZER\BIONTECH, 920175,CA,,M,"right side axillary lymph node swollen; This is a spontaneous report from a contactable other healthcare professional (HCP). A 27-year-old male patient (a registered nurse) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; batch/lot number: EK5730, expiration date: unknown), via an unspecified route of administration via injection to the right deltoid on 22Dec2020 at a single dose for COVID-19 immunization as he was working in a high risk patient population in the intensive care unit (ICU). The patient had no medical history. There were no concomitant medications. On 27Dec2020, the patient experienced right side axillary lymph node swollen, which was assessed as non-serious. It was further reported that the patient developed symptoms and stated at the injection site, he had a swollen lymph node, and he called his primary care physician; they did a telehealth visit, and he also reported to the hospital where he received the vaccine and he wanted to fulfill his reporting responsibilities and report to Pfizer, since he had received the vaccine. The patient further clarified the location and stated that the injection site was in the shoulder, but the lymph node was the same side, the axillary lymph node; it was not at the site, it was the axillary lymph node on the right side. The patient had no investigation assessment. The patient was not recovered from the event ""right side axillary lymph node swollen."" The causal relationship of the drug to the event ""right side axillary lymph node swollen"" was assessed by the reporting HCP as related; method of assessment: Global Introspection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/27/2020,5.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Lymphadenopathy'],1,PFIZER\BIONTECH, 920176,AZ,35.0,F,"tongue swell; This is a spontaneous report from a contactable consumer (patient herself; a therapist, but was not clarified). A 35-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; batch/lot number: EK5730, expiration date: unknown), via an unspecified route of administration on 26Dec2020 at a single dose for COVID-19 immunization administered at the workplace. Relevant medical history included bipolar II disorder, hand tremors, and sleep (disorder). Concomitant medications included lithium and lamotrigine (LAMICTAL), both for bipolar II disorder; carbidopa, levodopa for hand tremors; and trazodone for her sleep. The patient had the vaccination and her tongue swelled on 26Dec2020, probably about 15 minutes after she had the shot. The patient had no investigation assessment. In response to the event, the patient had taken diphenhydramine (BENADRYL) at 25 mg, once; just one time. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/26/2020,0.0,WRK,; LAMICTAL; CARBIDOPA LEVODOPA;,,Medical History/Concurrent Conditions: Bipolar II disorder; Sleep disorder; Tremor of hands,,,['Swollen tongue'],1,PFIZER\BIONTECH, 920177,FL,54.0,F,"hivers on lower back to side and left leg; joint stiffness over entire body; This is a spontaneous report from a contactable pharmacist. A 54-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: ett9899, expiration date: unknown), intramuscularly on the left arm on 17Dec2020 at 10:45 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included hypertension, diabetes, tachycardia, diverticulitis, and known allergies to pimentos. Concomitant medications included metformin and metoprolol tartrate (LOPRESSOR). The patient previously took valaciclovir hydrochloride (VALTREX) and experienced allergies to it. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced hivers on lower back to side and left leg and joint stiffness over entire body on an unspecified date in Dec2020 with hive improvement several days later. The patient received diphenhydramine (BENADRYL) and paracetamol (TYLENOL) orally from the emergency room as treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were assessed as non-serious. The patient recovered from the events ""hivers on lower back to side and left leg and joint stiffness over entire body"" on an unspecified date in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/01/2020,,PVT,; LOPRESSOR,,Medical History/Concurrent Conditions: Diabetes; Diverticulitis; Fruit allergy; Hypertension; Tachycardia,,,"['Joint stiffness', 'Urticaria']",1,PFIZER\BIONTECH,OT 920178,CA,45.0,F,"had a severe pain in upper left hip; hurt to lift my left leg up (while taking a step forward); This is a spontaneous report from a contactable nurse (patient). A 45-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscular in the left arm on 24Dec2020 08:15AM at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included lyme disease from 2014. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive other vaccines in last four weeks. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). On 25Dec2020 07:30AM, the patient had a severe pain in upper left hip. It felt like an IT band issue she had before but this time it didn't radiate to her knee like it usually does. She did not have exercise since the morning of the 22nd when she did an upper body weight-lifting session. She took ibuprofen that took the edge off, and she was able to finish her day as a nurse in the Covid ICU. The following morning, she felt fine and went to her other job. She was fine in the morning during her usual drills practicing getting out of the helicopter while on the ground. She sat in one of the seats for about 15 minutes while having a discussion when she started to feel the pain again. She got out of the helicopter and tried to walk around, but it hurt to lift her left leg up (while taking a step forward) in Dec2020. She has never experienced this before. She limped back to the hanger, took ibuprofen 600mg and rested/stretched for an hour. The pain was reduced to a minor and tolerable ache. The outcome of the events was recovering. The report was considered non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/01/2020,,PVT,LO LOESTRIN FE,,Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination); Lyme disease; Occupational exposure to COVID-19,,,"['Arthralgia', 'Pain in extremity']",1,PFIZER\BIONTECH,OT 920179,,,F,"Weird mental fog where she was lightheaded and dizzy; Weird mental fog where she was lightheaded and dizzy; Taste was diminished as well as her smell; Taste was diminished as well as her smell; Arm soreness; fatigue; This is a spontaneous report from a contactable physician (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2, via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The physician said she had the first dose of the COVID vaccine on 23Dec2020 (last Wednesday). She had arm soreness and fatigue the next day on 24Dec2020, but it was fine. Over the weekend she had less common symptoms. She had read on blogs that this could be vaccine related. She felt overall very well, but was wondering how long these symptoms should last? Three days after getting the vaccine she had a weird mental fog where she was lightheaded and dizzy on 26Dec2020. It was a weird sensation. She stayed in bed most of the day and did not do much. Saturday and Sunday she felt like her taste was diminished as well as her smell on 26Dec2020. It was still occurring this morning too. It was very noticeable that her taste and smell are diminished. She was wondering how long these things will last? The outcome of the events arm soreness and fatigue was recovered in Dec2020. The outcome of the events taste was diminished as well as her smell was not recovered. The outcome of the other events was unknown. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,UNK,,,,,,"['Dizziness', 'Fatigue', 'Hypogeusia', 'Hyposmia', 'Mental disorder', 'Vaccination site pain']",1,PFIZER\BIONTECH, 920180,,38.0,M,"Severe headache; Nausea; Sweats; Fatigue; This is a spontaneous report from a non-contactable physician. A 38-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscular in arm left on 18Dec2020 08:45 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included eczema. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient experienced 'Severe headache with nausea Sweats Fatigue' on 19Dec2020 09:00. Case was non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measures were taken as a result of events (Tylenol, Naproxen). The outcome of the events was recovered in Dec2020. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Eczema,,,"['Fatigue', 'Headache', 'Hyperhidrosis', 'Nausea']",1,PFIZER\BIONTECH,OT 920181,,,F,"Got first vaccine dose on the 18th and came out Covid test positive; Got first vaccine dose on the 18th and came out Covid test positive; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown) via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose on the 18th, and she came out Covid test positive yesterday (unspecified date in Dec2020). She wanted to know if she should get the second vaccine or what is the protocol into that. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/01/2020,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 920182,NY,61.0,F,"Diagnosed with COVID after receiving first dose of COVID-19 Vaccine; Diagnosed with COVID after receiving first dose of COVID-19 Vaccine; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number PAA156051, expiration date unknown), via an unspecified route of administration on 15Dec2020 16:00 at a single dose at the right arm for COVID-19 immunization. The patient has no medical history, no family medical history and no concomitant medications. The patient is a nurse in the Emergency Room. She had a first dose of COVID-19 vaccine on 15Dec2020. She was diagnosed with COVID after receiving first dose of COVID-19 vaccine on 23Dec2020. Due for second dose of COVID-19 vaccine on 04Jan2021. She wanted to know if she should go through with second dose if her symptoms subside. The COVID swab was done in the Emergency Room and was not admitted to hospital. The outcome of the event was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/15/2020,12/23/2020,8.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 920183,,,U,"tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable Pharmacist reported similar events for 2 patients. This is a 2nd of two reports. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on 14Dec2020 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter was a pharmacist asking if there was a contraindication for administering antibody therapy to a person after they had received the first dose of the covid vaccine. He reported that there was a patient that received the covid vaccine the week of 14Dec and subsequently tested positive for covid on the 23rd and 24th of December. The reporter was trying to determine the safety of administering antibody therapy for the patient even though the patient already got the first vaccine dose. The reporter reported this question had some urgency and needed the information within 48 hours. The patient underwent lab tests and procedures which included covid test: positive on 23Dec2020, positive on 24Dec2020. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the COVID test positive and vaccination with BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-2020516319 same reporter/ drug/ AE, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/14/2020,12/23/2020,9.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 920184,,40.0,M,"rash; This is a spontaneous report from a non-contactable Other HCP (patient). A 40-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ek5730), intramuscular in left arm on 16Dec2020 10:00 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included none. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included influenza vaccine (FLU) on 01Dec2020 at single dose for immunization. The patient experienced rash (non-serious) on 16Dec2020 16:00. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of rash (Benadryl). The outcome of event was recovered in Dec2020. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Rash'],1,PFIZER\BIONTECH,OT 920185,GA,23.0,F,"Fatigue; muscle soreness at site; muscle ache; mild joint pain; fever 100.1; This is a spontaneous report from a contactable nurse (patient). A 23-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 28Dec2020 12:00 at single dose at left arm for COVID-19 immunization. Medical history included known allergies: Penicillin, erythromycin. Concomitant medication received in two weeks included melatonin. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 15:00 (03:00 PM), the patient experienced fatigue, muscle soreness at site, muscle ache, mild joint pain, fever 100.1. Treatment received for the adverse events included Acetaminophen. The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Arthralgia', 'Body temperature', 'Fatigue', 'Myalgia', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 920186,,37.0,F,"severe sore arm in limb it was given; nausea; fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 37-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot number and expiry date were unknown), intramuscular in the right arm on 23Dec2020 10:15 at a single dose for COVID-19 immunization. The patient has no other medical history. The patient has no known allergies. The patient has no COVID prior vaccination, and COVID was not tested post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), escitalopram oxalate (LEXAPRO), and vitamin c (ascorbic acid). The patient has no other vaccine in the past four weeks. On 23Dec2020 01:00 PM, the patient experienced severe sore arm in limb it was given (by nighttime she was almost unable to use her right arm, improved by next morning), nausea, and fatigue. The outcome of the events was recovered in Dec2020. No treatment was received for the adverse events. The report was considered non-serious. No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,UNK,SYNTHROID; LEXAPRO; VITAMIN C [ASCORBIC ACID],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Fatigue', 'Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH,OT 920187,AZ,44.0,M,"mild nausea (on a scale of 1 to 5 ---like 2 to 3); little light headed (2 on a scale of 1 to 5); This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the left arm on 28Dec2020 10:00 at a single dose for COVID-19 immunization. Medical history included Epstein Barr, shingles in Oct2020 (2 months previous), detached retina in 2016 (4.5 years ago), and covid prior vaccination. There is no covid test done post vaccination. The patient's concomitant medications were not reported. The patiently previously had allergies to gentamycin. On 28Dec2020 12:00, the patient just had some mild nausea (like 2 to 3 on a scale of 1 to 5) and a little lightheaded (2 on a scale of 1 to 5). There is no treatment received for the adverse events. The outcome of the events was recovering. The report is considered non-serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,UNK,,,Medical History/Concurrent Conditions: COVID-19 (prior vaccination); Detached retina (4.5 years ago); Epstein-Barr virus infection; Shingles (2 months previous),,,"['Dizziness', 'Nausea']",1,PFIZER\BIONTECH, 920188,WI,49.0,F,"Dizziness; This is a spontaneous report from a contactable nurse (patient). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot number and expiry date were unknown), via an unspecified route of administration in the left arm on 28Dec2020 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient did not receive other vaccines in the last four weeks. Concomitant medications included omeprazole (PRILOSEC), metoprolol, levothyroxine sodium (SYNTHROID), aciclovir sodium (ACYCLOVIR VIAL), and meloxicam (MOBIC). The patient previously had allergies with morphine. On 28Dec2020, the patient experienced dizziness 12 hours after injection with outcome of recovering. The patient did not receive treatment for the reported adverse event. The report was considered non-serious. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,PRILOSEC [OMEPRAZOLE]; ; SYNTHROID; ACYCLOVIR VIAL; MOBIC,,Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination),,,['Dizziness'],1,PFIZER\BIONTECH, 920189,,,F,"headaches; kinda unwell; difficulty in finishing sentences; feeling drugged; This is a spontaneous report from a contact physician (patient) from a Pfizer-sponsored program Pfizer First Connect. A female patient of unspecified age received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. After taking the Covid-19 vaccine, she's experiencing headaches, kinda unwell, difficulty in finishing sentences, and feeling drugged. Outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,,,UNK,,,,,,"['Headache', 'Malaise', 'Sedation', 'Speech disorder']",1,PFIZER\BIONTECH, 920190,AL,26.0,M,"Nausea; Vomiting; Diarrhea; Bad dreams; Extreme chills; Heavy amount of sweating; This is a spontaneous report from a contactable other HCP (patient). A 26-year-old male patient received the first dose of BNT162B2 (lot number: EK5730), via an unspecified route of administration in left arm, on 24Dec2020 09:30 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Allergies to medications, food, or other products included Bactrim. Relevant medical history included Kyphosis, Binge Eating Disorder, Anxiety, Depression, ADHD, Obesity, Hypertension, all ongoing. No other vaccines were received within 4 weeks prior to the COVID vaccine. The medications received within 2 weeks of vaccination included omeprazole(PROTONIX), Lisinopril, HCTZ, Atenolol, vilazodone hydrochloride(VIIBRYD). The patient experienced Nausea, Vomiting, Diarrhea, Bad dreams, Extreme chills, Heavy amount of sweating, Elevated motivation to work/be productive, Very optimistic on 28Dec2020 01:00 PM. No treatment was received for the events. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/28/2020,4.0,WRK,PROTONIX [OMEPRAZOLE]; ; HCTZ; ; VIIBRYD,ADHD; Anxiety; Binge eating; Depression; Hypertension; Kyphosis; Obesity,,,,"['Chills', 'Diarrhoea', 'Hyperhidrosis', 'Nausea', 'Nightmare', 'Vomiting']",1,PFIZER\BIONTECH, 920191,AK,28.0,F,"Tenderness, redness, and swollen at injection site. Approximately 2 inches by 1 inch in size.; Tenderness, redness, and swollen at injection site. Approximately 2 inches by 1 inch in size.; Tenderness, redness, and swollen at injection site. Approximately 2 inches by 1 inch in size.; This is a spontaneous report from a contactable other HCP (patient herself). This 28-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unspecified route of administration, on 19Dec2020 at 15:00 at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was not pregnant. Relevant medical history included sinus tachycardia and obstructive sleep apnea. Patient's Body mass index (BMI) is more than 35. No known allergies. Relevant concomitant medications included ibuprofen. The patient was vaccinated at Clinic, age at vaccination was 28-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. On 28Dec2020, at 12:30, the patient developed tenderness, redness, and swollen at injection site, approximately 2 inches by 1 inch in size. The patient was not treated for the events. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/28/2020,9.0,WRK,,,Medical History/Concurrent Conditions: Obstructive sleep apnea syndrome; Sinus tachycardia,,,"['Body mass index', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",UNK,PFIZER\BIONTECH, 920192,CA,42.0,F,"Sore arm; nocturnal diaphoresis; generalized mild pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EJ1685), via an unspecified route of administration, on 18Dec2020 at 02:45 PM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 42-years-old. No other vaccine was received in four weeks. Medical history included prior to vaccination the patient diagnosed with COVID-19 and known allergies were Penicillin (PCN), ephedrine, calamine, calendula, pollen. Concomitant medications included escitalopram 10mh. On 19Dec2020 at 07:00 AM, the patient experienced sore arm, nocturnal diaphoresis, generalized mild pain, fatigue. The events were reported as non-serious. The patient recovered in Dec2020 form the events. No treatment was received.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,,,"Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination, the patient diagnosed with COVID-19); Penicillin allergy (Known allergies: PCN); Pollen allergy (Known allergies: Pollen)",,,"['Fatigue', 'Night sweats', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 920193,,,F,"Rash all over belly; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: rash all over belly (non-serious). The clinical outcome of the event was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Rash'],UNK,PFIZER\BIONTECH, 920194,UT,48.0,M,"weak from lack of nutrition; weak from lack of nutrition; Tired; stomach cramps; felt out of breath; nausea; vomiting when exercised; headache; Sore arm; chills; no appetite; clammy hands/clammy hands and feet; very sore at injection site; This is a spontaneous report from a contactable other HCP (patient) reported for himself. A 48-years-old male patient received first dose of BNT162B2, via intramuscular in left arm on 21Dec2020 10:15 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included known allergies: Shellfish, Corn, Whitefish. The patient's concomitant medications were none. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested for COVID-19 since the vaccination. The patient experienced no appetite, clammy hands, very sore at injection site on 21Dec2020 (reported as day 1), sore arm, no appetite, clammy hands and feet, chills on 22Dec2020 (reported as day 2), no appetite, nausea, vomiting when exercised, headache, clammy, chills on 23Dec2020 (reported as day 3), no appetite, nausea, stomach cramps, headache, felt out of breath, clammy, chills on 24Dec2020 (reported as day 4), tired, clammy, headache on 25Dec2020 (reported as day 5) and symptoms resolved but weak from lack of nutrition on 26Dec2020 (reported as day 6). No treatment was received for all the events. The outcome of the events was recovered in Dec2020. The information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,,,"Medical History/Concurrent Conditions: Food allergy (Known allergies: Shellfish, Corn, Whitefish)",,,"['Abdominal pain upper', 'Asthenia', 'Chills', 'Cold sweat', 'Decreased appetite', 'Dyspnoea', 'Fatigue', 'Headache', 'Malnutrition', 'Nausea', 'Pain in extremity', 'Vaccination site pain', 'Vomiting']",1,PFIZER\BIONTECH,OT 920195,,,F,"strawberry tongue /taste buds popped up and inflamed like I'd eaten something sour. It was all inflamed; rash the next day and a few days after I got a rash on my chest; This is a spontaneous report from a contactable healthcare professional, the patient. A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have a history of rash or food allergies. In Dec2020, the patient experienced strawberry tongue and rash. The clinical course was as follows: the patient stated that she believed she had a delayed reaction to the vaccine as it didn't happen within 15 minutes. It happened later on (not further specified). She started to get a strawberry tongue and described it as ""taste buds popped up and inflamed like she had eaten something sour."" It was all inflamed. She also noticed a rash the next day and a few days after she got a rash on her chest. The clinical outcomes of the strawberry tongue and rash were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Rash', 'Strawberry tongue']",1,PFIZER\BIONTECH, 920196,MI,62.0,M,"felt a little sick; I got my temperature about 100.2/Fever that I have is 7 days after the vaccine; Had mild body ache; Chills; Usual soreness at the site of injection; Cough; mild sore throat; This is a spontaneous report from a contactable Physician (patient). A 62-year-old male patient received NT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL01-40), via an unspecified route of administration on 20Dec2020 09:30 at single dose for COVID-19 immunization. Anatomical Location provided as Left deltoid. Medical history provided as none. Concomitant medication included hydrochlorothiazide, levothyroxine sodium (SYNTHROID). Physician stated, he got his Pfizer vaccine on last Sunday on 20Dec2020 around 9:30 there was usual soreness at the site of injection on 20Dec2020, which was there but no problem. But Monday (21Dec2020) after his vaccine that was Sunday he had and Monday night on 21Dec2020 he had chills he thought these were all just the reaction to the vaccine. Next day on 22Dec2020 he went into work he had mild body ache at work, at about 3:30 he felt a little sick and he got his temperature about 100.2, get home rested, next day on 23Dec2020 he worked from home, did not go so for next four days (from 24Dec2020 to 27Dec2020) he rested at home but his chills and body ache are not going away. They were there, they come and go, he took Tylenol, it went he have mild sore throat, cough on Dec2020. Today on 27Dec2020, the patient just took the temperature 100.7. For Causality assessment: Physician stated, ""he didn't know, he was just trying to find out to get to bottom of it. Is it really COVID infection or is it due to side effects as from what he read the reaction shouldn't really last long. It may last probably 3-4 days but this has gone beyond that so he was little concerned and the fever that he had was 7 days after the vaccine."" The patient still had chills and body ache which he means they were not going away and now mild fever. When probed for the outcome of, Physician stated, ""They are persistent you know some day he had one day which was good but after that in the afternoon in the evening he felt the same thing. Fortunately, he was off for four days it didn't really have much problem, physically it was persistent has not gone away."" Therapeutic measures were taken as a result of chills, had mild body ache, felt a little sick, cough, fever, mild sore throat. The outcome of events chills, mild body ache was not recovered. The outcome of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/01/2020,,UNK,; SYNTHROID,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'Chills', 'Cough', 'Illness', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 920197,MA,,F,"tested positive; tested positive; This is a spontaneous report from a contactable nurse reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 22Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the COVID vaccine on 22Dec2020 and tested positive (COVID) on 27Dec2020, she didn't expect to be immune. The outcome of the event tested positive was unknown. Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded. Further information like specific SARS-CoV-2 test and any symptom associated with SARS-CoV-2 test positive needed for full medical assessment",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/27/2020,5.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 920198,AZ,20.0,F,"Dizzy; a little weak; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot Number EH9899/Expiration date: not provided), via an unspecified route of administration, on 27Dec2020 at 8:07am (at the age of 20-years-old), as a single dose for COVID-19 vaccination. Relevant medical history was not provided. Concomitant medication included medroxyprogesterone acetate (DEPO-PROVERA) shot every 3 months for birth control. On 27Dec2020 at 9:41am, the patient reported that while she was at the grocery store, after she received the vaccine, she got kind of dizzy and a little weak. The consumer believed the effects were due to the vaccine, as she had not experienced this before. The outcome of the events dizzy and weak were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,12/27/2020,0.0,UNK,DEPO-PROVERA,,,,,"['Asthenia', 'Dizziness']",1,PFIZER\BIONTECH, 920199,PA,51.0,F,"Taste alteration; Funny taste; This is a spontaneous report from a contactable Pharmacist. A 51-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, on 28Dec2020 at 03:15 PM at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was vaccinated at workplace clinic, age at vaccination was 51-years-old (reported also as 49-years-old, to be clarified). No other vaccine was received in four weeks. Medical history included thryoid disease, and current tx for pulmonary embolism (PE, 3months). Concomitant medications included levothyroxine sodium (SYNTHROID), apixaban (ELIQUIS). On 28Dec2020 at 03:15 PM, the patient experienced taste alteration - funny taste upon injection. Transient. Lasted 10 seconds or so. The event was reported as non-serious. Outcome of the event was recovered on 28Dec2020. No treatment was received for the event. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,ELIQUIS; SYNTHROID,Pulmonary embolism (Current tx for PE (3months)),Medical History/Concurrent Conditions: Thyroid disorder,,,"['Dysgeusia', 'Taste disorder']",1,PFIZER\BIONTECH,OT 920200,CA,46.0,F,"severe intractable headache; photo sensitivity; generalised body malaise; pain & tenderness in injection site; nausea; This is a spontaneous report from a contactable physician. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 23Dec2020 01:00AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was hospital. The patient medical history was not reported. Concomitant medication included folic acid, ascorbic acid (VIT C), tocopherol (VITAMIN E), Multivitamins. The patient previously took metronidazole and experienced drug allergy, NTG and experienced drug allergy. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe intractable headache, photo sensitivity, generalised body malaise, pain & tenderness in injection site, nausea on 23Dec2020 12:00 PM. Patient received Tylenol, neurofen and rest as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The events were reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,; VIT C; VITAMIN E,,,,,"['Headache', 'Malaise', 'Nausea', 'Photosensitivity reaction', 'Vaccination site pain']",1,PFIZER\BIONTECH, 920201,,31.0,F,"fever; myalgia; body ache; fatigue; This is a spontaneous report from a non-contactable other healthcare professional (HCP). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number ek5730) intramuscular in the left arm on 20Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 24Dec2020, the patient experienced fever, myalgia, body ache and fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19. After the vaccination, on 26Dec2020, the patient was tested for COVID-19 with a nasal swab which resulted negative. At the time of the report, the outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/24/2020,4.0,UNK,,,,,,"['Fatigue', 'Myalgia', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 920202,GA,,F,"Joint pain and Chills; Joint pain and Chills; This is a spontaneous report from a contactable physician received via a sales representative. A female patient of an unspecified age received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced joint pain and chills on an unspecified date. The outcome of the events was unknown. Events took place after use of product. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Arthralgia', 'Chills']",UNK,PFIZER\BIONTECH, 920203,MO,20.0,F,"tired; stomach pain; swelling at site; itching; body aches; headache; lightheaded; This is a Spontanoeus report from a contactable other HCP (patient) A 20 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 28Dec2020 at 11:00 AM, at single dose on left arm for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 28Dec2020 at 11:45 PM the patient experienced stomach pain, swelling at site, itching, body aches, headache, lightheaded, tired. At the time of the reporting the patient was recovering from reported events. No follow-up attempts are possible; information about lot/batch number cannot be obtained, No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Abdominal pain upper', 'Dizziness', 'Fatigue', 'Headache', 'Pain', 'Pruritus', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 920204,RI,,U,"Red rash on her chest and arms; Had a tightness and lump in her throat; Had a tightness and lump in her throat; Cheeks were flushed; This is a spontaneous report from a contactable nurse and contactable physician. This nurse reported similar events for 3 patients. This is the 2nd of 3 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced red rash on chest and arms, tightness and lump in throat and cheeks were flushed. The patient outcome of the events was unknown. The information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020516277 different patient, same drug and same event.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Flushing', 'Rash erythematous', 'Sensation of foreign body', 'Throat tightness']",1,PFIZER\BIONTECH, 920205,RI,,U,"red rash on her chest and arms; had a tightness and lump in her throat; had a tightness and lump in her throat; cheeks were flushed; This is a spontaneous report from a contactable nurse and contactable physician. This nurse reported similar events for 3 patients. This is the 3rd of 3 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced red rash on chest and arms, tightness and lump in throat and cheeks were flushed. The patient outcome of the events was unknown. The information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020516277 different patient, same drug and same event;US-PFIZER INC-2020517133 different patient, same drug and same event.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Flushing', 'Rash erythematous', 'Sensation of foreign body', 'Throat tightness']",1,PFIZER\BIONTECH, 920206,NY,62.0,M,"knee pain; This is a spontaneous report from a contactable physician (patient). This 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK5730), via an unspecified route of administration, on 20Dec2020 at 07:15 AM at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was vaccinated at hospital, age at vaccination was 62-years-old. No other vaccine was received in four or two weeks. Medical history was unknown. Concomitant medications were none. Th patient developed left (L) knee pain (7/10) on 23Dec2020 which has not yet resolved as of 28Dec2020. No treatment was administered for the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/23/2020,3.0,PVT,,,,,,"['Arthralgia', 'Pain assessment']",1,PFIZER\BIONTECH, 920207,NY,50.0,U,"Pain in my arm where I received the vaccine; Cannot raise my arm ; like my shoulder; Fatigue; I thought maybe I dislocated the shoulder; Starting to feel like pretty bad joint pain like I sub-located the joint; Feels like strain; Muscle pain; This is a spontaneous report from a contactable nurse, the patient. A 50-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Batch/lot number: EK9231; Expiry Date: 30Apr2021), via an unspecified route of administration in an unspecified site on 26Dec2020 around 12:40 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. The patient has no relevant medical history. The patient's concomitant medications were not reported. I received the Covid vaccine today and I am a Nurse and I am having pretty significant pain in my arm where I received the vaccine. Consumer (Nurse) stated, ""I had the vaccine at around 12:40. I came back to my unit and around 3:00PM, I moved a patient. I was holding a patient and so I thought maybe some of that was just fatigue from holding a patient in the procedure but and then I started to move it and I thought maybe I dislocated the shoulder. I was starting to feel like pretty bad joint pain like I sub-located the joint and then it started to be in you know, then I was like really trying to concern like what the sensation was that I was feeling .Knowing all while I got the vaccine and I am feeling the muscle sort of feels like strain. I was told that I cannot say for sure if it just the vaccine. It could also be the handling the patient. But it is both types of pain like looking at the side effects it says joint pain, muscle pain. Injection site pain I do not have. Tiredness and headache no. So it is Muscle pain and joint pain I have. I took a Tylenol (not further clarified) as the pain really started to bother me at around 4. I took Tylenol at about 5 and I started putting an ice pack at around 5:30. It is still pretty significant I would say with those interventions this calmed down to about at 6 and I cannot raise my arm like to my shoulder. I am scheduled to get the second shot on the 17th."" It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. The patient took Tylenol for pain. The clinical outcome of vaccination site pain, vaccination site movement impairment, fatigue, joint pain, myalgia, was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/26/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Fatigue', 'Muscle strain', 'Myalgia', 'Vaccination site movement impairment', 'Vaccination site pain']",1,PFIZER\BIONTECH, 920208,CA,,F,"shortness of breath; dizziness; Little tenderness at arm site; My feet, particularly they were hurting; It was bad enough that I was wrapping my feet and ankle to support my feet; There was a funny taste or like a tingling sensation on the roof of my mouth; There was a funny taste or like a tingling sensation on the roof of my mouth; I got upset over something and my blood pressure shot up; I still feel it sometimes; I felt a little bit of numbness along my face; Little bit of dead feeling on your skin when you touch your skin; It got worst each day/attacked all my prior injuries; Difficulty breathing; Joint pain; This is a spontaneous report from a contactable consumer. A 50-year-old female patient (medical assistant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EK5730), via an unspecified route of administration on 19Dec2020 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital urgent care. Medical history included Bilateral carpal tunnel, fatty liver, peptic ulcer, and problems with my upper extremities - all from and unspecified date to an unspecified date. Concomitant medications included Omeprazole 20 mg unspecified frequency and route of administration (MANUFACTURER UNKNOWN) and Vitamin Supplement (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On an unspecified date, the patient stated, ""The first side effect was immediate within the 15 minutes monitoring and I didn't say anything to anybody. Yes, when I first got it, they watch you for 15 minutes to make sure you're okay. When I had that done and I didn't report it because it was manageable but then I had little more trouble breathing, I got dizzy feeling. I don't know if there was a funny taste or like a tingling sensation on the roof of my mouth. I did continue to have those for first three days but it got a little better it got better through the day. On the third day, that the evening I know I got upset over something and my blood pressure shot up. I am usually fine with blood pressure, I never had a problem. I think my blood pressure shot up, I got little upset and all those symptoms came back real hard when I first got my vaccine. It is improved but I still feel it sometimes. When I got all upset and when it all come back I felt a little bit of numbness along my face that I never had before. There was a little bit of dead feeling on your skin when you touch your skin. when I first got the vaccine which was the difficulty breathing and kind of dizziness and stuff but it was okay, it went away and everything. It came back a few days later when I had got really upset, I think my blood pressure increasing, I am sure that time it made kind of come back. Other than that I feel really good just little tenderness at arm site, the first day that was it. But by Tuesday, I started having joint pain and I didn't associate, I have problems with my feet from a prior injury and I thought may be the weather change was making them hurt but I just wanted, I didn't think about my feet be like joint pain but from the vaccine it seem to have attacked all my prior injuries and I am 50 year old, now every bit of me and every one of my joints. My feet, particularly they were hurting when I started crossing the parking lot at work on Tuesday, by Wednesday it was bad enough that I was wrapping my feet and ankle to support my feet more and by Thursday the Christmas eve. The doctor said go ahead and take some ibuprofen but like it seems to just be changing now it's little better today. Everywhere you had an injury and it's still okay, I am still thankful for the vaccine. I am just curious the second time I get it, I was reading today that the effects could be worst the second time for the second dose. I was just wondering particularly since I had shortness of breath, dizziness and things like that when I first got the vaccine. Do I just need to do I mean I am sure it is still safe to get the second one, do I need to make sure I let the staff know they are doing that, do I need know do that any like a Benadryl I had at that time?"" The patient received Benadryl as treatment for the events (unspecified which events). The clinical outcome of the events difficulty breathing, shortness of breath, dizziness, tenderness at arm site, Painful feet, Taste abnormality, Tingling mouth, Blood pressure increased, Numbness facial, and Condition aggravated was unknown. The clinical outcome of the event Joint pain was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/22/2020,,UNK,,,Medical History/Concurrent Conditions: Carpal tunnel syndrome (Verbatim: Bilateral carpal tunnel); Fatty liver (Verbatim: Fatty liver); Foot injury; Peptic ulcer (Verbatim: Peptic ulcer),,,"['Arthralgia', 'Blood pressure increased', 'Blood pressure measurement', 'Condition aggravated', 'Dizziness', 'Dyspnoea', 'Hypoaesthesia', 'Investigation', 'Pain in extremity', 'Paraesthesia oral', 'Taste disorder', 'Vaccination site pain']",1,PFIZER\BIONTECH, 920209,,,F,"Throat started hurting; This is a spontaneous report from a contactable nurse (patient herself). A 36-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was seeking information on the Covid-19 vaccine side effects and mentioned that her throat started hurting for 8-12 hours (h) after receiving the vaccine on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Oropharyngeal pain'],UNK,PFIZER\BIONTECH, 920210,MI,26.0,F,"Arm tenderness; This is a spontaneous report from a non-contactable healthcare professional. A 26-year-old female patient started received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration on the right arm on 28Dec2020 16:00 at a single dose for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. The patient experienced arm tenderness on 28Dec2020. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Pain in extremity'],1,PFIZER\BIONTECH, 920211,,,F,"rash over her ear; The rash then spread on her elbow, hips, legs, stomach and back; The rash then spread on her elbow, hips, legs, stomach and back; This is a spontaneous report from a non-contactable nurse reporting for herself. A 55-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 19Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash over her ear on 21Dec2020 with outcome of unknown, the rash then spread on her elbow, hips, legs, stomach and back on 21Dec2020 with outcome of unknown. The events were considered non serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/21/2020,2.0,UNK,,,,,,['Rash'],UNK,PFIZER\BIONTECH, 920212,TN,,U,"Received the first dose of the vaccine; Have now tested positive; Received the first dose of the vaccine; Have now tested positive; This is a spontaneous report from a pharmacist. It was reported that a patient of unspecified age and gender received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine; and have now tested positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the reported events and vaccination with BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 920213,IN,,F,"rash on the administration site; it is localized on the administration site (which also is sore); This is a spontaneous report from a contactable Nurse reporting for herself. A 34-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, 1 day after vaccination, the patient experienced rash on the administration site. The rash has not extended all over her body, it was localized on the administration site (which also is sore). The outcome of events was unknown. She has not experienced similar reactions with other vaccines. Patient queried if she should receive the 2nd dose. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Vaccination site pain', 'Vaccination site rash']",1,PFIZER\BIONTECH, 920214,MO,66.0,M,"Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; This is a spontaneous report from a contactable physician. A 66-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Batch/lot # EH9899) intramuscular at single dose on28Dec2020 18:00 for Covid-19 immunisation, administered at hospital. Medical history included Covid-19: he tested positive for COVID and received the monoclonal antibody, bamlanivimab on 13Dec2020; other unspecified health conditions which might make him high risk. The patient previously received monoclonal antibody 17-1a, bamlanivimab on 13Dec2020. For Covid-19. The patient received other unspecified medications in two weeks. On 28Dec2020 21:00, 3 hours after vaccination, he was feeling bad with flu-like symptoms, nausea, headache, dizziness, fatigue and diarrhea. No treatment received. Covid was not tested post vaccination. The outcome of events was not recovered. His colleague now knows he should have waited 90 days after the antibody but reporter was wondering if there was information. Since there probably is no information, this is a unique situation and reporter wondered if Pfizer wants him to run any particular tests or send in some blood to Pfizer for testing to further medical knowledge on giving the vaccine within 90 days of the antibodies.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,,"Medical History/Concurrent Conditions: COVID-19 (received the monoclonal antibody, bamlanivimab)",,,"['Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Influenza like illness', 'Nausea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 920215,MD,,F,"Having a fast heartbeat; Swelling in arm; Its just a little bit achy; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received bnt162b2 (BNT162B2; Lot # EH9899) vaccine , via an unspecified route of administration on 27Dec2020 10:00 at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included metformin (METFORMIN), atorvastatin (ATORVASTATIN), ezetimibe (ZETIA), fenofibrate (FENOFIBRATE). The patient experienced swelling in arm on 27Dec2020 with outcome of unknown , having a fast heartbeat on 28Dec2020 with outcome of unknown , its just a little bit achy on Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included heart rate: fast on 28Dec2020 .",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,12/01/2020,,UNK,; ; ZETIA;,,,,,"['Heart rate', 'Heart rate increased', 'Pain', 'Peripheral swelling']",UNK,PFIZER\BIONTECH, 920216,IL,39.0,F,"burning of eyes; hot flashes followed by rigors; severe muscle pain; For hrs post injection I had hot flashes; skin pain; joint pains; numbness of the whole arm; site pain; Headaches; low grade fever; This is a spontaneous report from a contactable nurse (patient). A 39-years-old female patient (no pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EJ1685, Expiration Date: 31Mar2021), via an unspecified route of administration in left arm on 28Dec2020 09:00 at single dose for COVID-19 immunization. Medical history included obesity, asthma, hypothyroidism, vitamin D deficiency, multiple tendonitis, allergies to horses, cats, and dogs and the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included mometasone furoate (ASMANEX), colecalciferol (VITAMIN D), levothyroxine sodium (SYNTHROID) and hydroxychloroquine, all received within 2 weeks of vaccination. The patient stated for hours post injection she had hot flashes but the worst was 12hrs after. She experienced severe muscle pain/ skin pain, joint pains, burning of eyes, Headaches, low grade fever, site pain, numbness of the whole arm, hot flashes followed by rigors. The events started on 28Dec2020 21:00. Treatment received for the events included Tylenol. The events were reported as non-serious. The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,ASMANEX; VITAMIN D [COLECALCIFEROL]; SYNTHROID;,,"Medical History/Concurrent Conditions: Allergy to animals; Asthma; COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?:Yes); Hypothyroidism; Obesity; Tendonitis (multiple tendonitis); Vitamin D deficiency",,,"['Arthralgia', 'Chills', 'Eye irritation', 'Headache', 'Hot flush', 'Hypoaesthesia', 'Myalgia', 'Pain of skin', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 920217,NY,31.0,F,"I have got tingling in both of my arms; like a lightness, it's like my arms felt very light; I have got tingling in both of my arms; like a lightness, it's like my arms felt very light; Hypertensive; Tachycardiac; This is a spontaneous report from a contactable physician (patient). This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left arm on 22Dec2020 for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID) at 112 ug on 22Dec2020 for hypothyroidism. Physician stated, ""I was about 2 minutes after the administration of vaccination on 22Dec2020, I have got tingling in both of my arms as well as hard to describe but like a lightness, it's like my arms felt very light. And they observed me and took my vitals and I was definitely hypertensive and tachycardiac"". The outcome of the events was unknown. The vaccine was administered at Hospital Facility.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,PVT,SYNTHROID,,Medical History/Concurrent Conditions: Hypothyroidism,,,"['Hypertension', 'Muscular weakness', 'Paraesthesia', 'Tachycardia']",1,PFIZER\BIONTECH, 920218,CA,,F,"pain/tenderness underneath the arm, ""like a band, swollen and tender""; pain/tenderness underneath the arm, ""like a band, swollen and tender""; pain/tenderness underneath the arm, ""like a band, swollen and tender""; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 19Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Dec2020, the patient experienced pain/tenderness underneath the arm, ""like a band, swollen and tender"" (non-serious). The clinical outcome of the events was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/27/2020,8.0,UNK,,,,,,"['Pain in extremity', 'Peripheral swelling', 'Tenderness']",UNK,PFIZER\BIONTECH, 920219,IL,68.0,M,"I developed a case of herpes zoster on my left flank area; This is a spontaneous report from a contactable physician. A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on the left arm on 20Dec2020 01:15 at single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, coronary artery disease, asthma, hypertension, and gastrooesophageal reflux disease (GERD). Concomitant medications included irbesartan, sulfasalazine, and hydroxychloroquine. The patient previously took lansoprazole (PREVACID) and experienced drug allergies. On 28Dec2020, the patient developed a case of herpes zoster on his left flank area. Therapeutic measure was taken as a result of herpes zoster that included valaciclovir (Valtrex). Clinical outcome of event was recovering. Information on lot/Batch Number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/28/2020,8.0,PVT,; ;,,Medical History/Concurrent Conditions: Asthma; Coronary artery disease; GERD; Hypertension; Rheumatoid arthritis,,,['Herpes zoster'],UNK,PFIZER\BIONTECH, 920220,AL,,U,"tachycardia; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tachycardia on an unspecified date. The outcome of event was unknown. The physician wanted to know the side effect of tachycardia resolves on it's own or if intervention is needed, if side effects would increase at the 2nd dose, should Md pre-medicate for second dose or avoid 2nd dose. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Tachycardia'],UNK,PFIZER\BIONTECH, 920221,,48.0,F,"Temp max 100.2F (tympanic thermometer); Chills; Body aches; Joint pain; Swollen cervical lymph nodes; Fatigue; This is a spontaneous report from a contactable nurse (patient herself). This 48-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unknown route, on 23Dec2020 at 11:30 AM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was not pregnant. Relevant medical history included well-controlled hypertension, gastrooesophageal reflux disease (GERD), seasonal allergies (pollen only) and well -controlled depression. Relevant concomitant medications included losartan, spironolactone, wellbutrin, omeprazole (PRILOSEC) and cetirizine hydrochloride (ZYRTEC). The patient was vaccinated at Workplace Clinic, age at vaccination was 48-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. On 24Dec2020 at 01:00 AM, the patient had temp max 100.2 F (tympanic thermometer), chills, body aches, joint pain, swollen cervical lymph nodes and fatigue. No treatments were taken for the events. The patient had recovered from the events on unknown date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,WRK,; ; WELLBUTRIN; PRILOSEC [OMEPRAZOLE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Depression (well -controlled); GERD; Hypertension (well-controlled); Pollen allergy,,,"['Arthralgia', 'Body temperature', 'Chills', 'Fatigue', 'Lymphadenopathy', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 920222,NC,44.0,F,"Vomiting; diarrhea; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, lot # Ek5730) at single dose to right arm on 22Dec2020 for Covid-19 immunisation. Medical history and concomitant medications were none. The patient experienced severe reaction of vomiting and diarrhea on 24Dec2020, about 48 hours after vaccination, lasted about 7 hours, it went away on 24Dec2020, and she has recovered completely, but it took days to get back to normal. The outcome of events was recovered on 24Dec2020. She queried if it is safe to get the 2nd dose, if it makes her feel like the 1st one, she doesn't want it.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Diarrhoea', 'Vomiting']",1,PFIZER\BIONTECH, 920223,,,M,"chills; achy joints; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills and achy joints on Dec2020 with outcome of recovering. Patient was still experiencing the symptoms but was feeling better. The patient wanted to know how long symptoms typically last after vaccination. Information about Lot/batch no has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/01/2020,,UNK,,,,,,"['Arthralgia', 'Chills']",UNK,PFIZER\BIONTECH, 920224,TX,35.0,M,"had a positive COVID test; had a positive COVID test; O2 Saturation of 80% / Hypoxia; shortness of breath; He has a CT scan which showed extensive infiltration in the lungs; muscle pain; chills; body aches; low grade fever; cough; This is a spontaneous report from a contactable physician (pulmonary medicine). This physician reported similar events for 2 patients. This is 1st of 2 reports. A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. There were no medical history and concomitant medications. Caller stated that his close friend who was ER physician (front line worker) and within 24 hours after receiving the COVID vaccine, developed COVID or symptoms of COVID. Patient received the COVID vaccine on 18Dec2020 and the same night patient started with a low grade fever, body aches, chills, muscle pain, shortness of breath, cough, O2 saturation of 80% (hypoxia) and was in the intensive care unit now. Patient swore this was related to the vaccine. This patient tested positive for COVID. He had a CT (computerised tomogram) scan which showed extensive infiltration in the lungs in Dec2020. Patient was admitted to the hospital on 24Dec2020 and then was moved to the ICU 2 days later, on 26Dec2020. Caller thought patient had a positive COVID test at another hospital. Caller did know that tested positive at the current hospital on 26Dec2020 which was done to confirm the previous positive test. Caller thought patient had his first positive COVID test either the same day or the next day after receiving the vaccine. Event of O2 Saturation of 80% / hypoxia was reported as hospitalization from 24Dec2020 and life threatening; infiltration in the lungs and shortness of breath caused hospitalization from 24Dec2020, muscle pain, chills and positive COVID test was reported as medically significant; and other events were reported as non-serious. Outcome of O2 saturation of 80% / hypoxia and shortness of breath was not recovered, outcome of cough was recovering; and outcome of other events were unknown. Information about lot/batch number has been requested. ; Sender's Comments: Based on the information currently available, a lack of efficacy with suspected vaccine BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-2020519020 same reporter/drug , different patient/AE.",Not Reported,,Yes,Yes,,Not Reported,N,12/18/2020,12/01/2020,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'Chills', 'Computerised tomogram abnormal', 'Cough', 'Dyspnoea', 'Hypoxia', 'Intensive care', 'Lung infiltration', 'Myalgia', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 920225,CA,54.0,F,"Anaphylactic reaction requiring two doses of Epinephren to control. Still having issues; other vaccine same date product received; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm at 12:30 PM on 18Dec2020 at single dose for COVID-19 immunization, and first dose of other Pfizer vaccine same date product (other vaccine same date lot number: elt9899) on right deltoid on 18Dec2020 for unknown indication. Medical history reported as none. Concomitant medication included vitamin C and colecalciferol (VITAMIN D). The patient experienced anaphylactic reaction at 12:30 PM on 18Dec2020 requiring two doses of epinephren to control. still having issues, resulted in: Doctor or other healthcare professional office/clinic visit, Hospitalization in Dec2020. days hospitalization: 1. The patient received treatment: 2 doses of epinephrine, solumedrol, benadryl, IV and O2 for event anaphylactic reaction to vaccine. The outcome of anaphylactic reaction was not recovered. Lot/Batch and Expiration date has been requested.; Sender's Comments: The information available in this report is limited and anecdotal and does not allow a medically meaningful assessment of the case. There is a plausible temporal association between vaccines administration and onset of the reported event. It is unclear what is the nature of the vaccine co-administered with BNT162b2. Currently no information is available on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Anaphylactic reaction', 'Viral test negative']",1,PFIZER\BIONTECH,OT 920226,IN,,F,"fever; headache; increased heart rate; increased blood pressure; congestion; back hurting; joint pain; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunisation. Medical history breast cancer with surgical treatment in Nov2019 and radiation treatment in Feb2020. The patient previously took zinc oxide and experienced headache. Concomitant medication included anastrozole (unknown manufacturer), calcium (unknown manufacturer), colecalciferol (VITAMIN D), ascorbic acid, bioflavonoids nos (unknown manufacturer). On 21Dec2020 the patient experienced fever, headache, increased heart rate, increased blood pressure, congestion, joint pain with outcome of not recovered and back hurting between the shoulder blades with outcome of recovering. She took paracetamol (TYLENOL) as treatment for the fever. The consumer states she was still having all of these side effects but the back pain was a little better now. The patient wanted to know if she should get the second dose of the Pfizer-Biontech Covid-19 vaccine since she was experiencing side effects after the first injection. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,UNK,; ; VITAMIN D [COLECALCIFEROL]; VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS],,Medical History/Concurrent Conditions: Breast cancer female (breast cancer with surgical treatment in Nov2019 and radiation treatment in Feb2020); Malignant breast lump removal; Radiation therapy,,,"['Arthralgia', 'Back pain', 'Blood pressure increased', 'Blood pressure measurement', 'Headache', 'Heart rate', 'Heart rate increased', 'Nasal congestion', 'Pyrexia']",1,PFIZER\BIONTECH, 920227,VA,28.0,F,"Diarrhea; nausea; This is a spontaneous report from a contactable other hcp. A 28-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscular from 28Dec2020 09:00 to 28Dec2020 09:00 single dose for COVID-19 immunisation. Medical history included haemochromatosis from an unknown date, rubber sensitivity from an unknown date. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC), trazodone, quetiapine fumarate (SEROQUEL), sertraline hydrochloride (ZOLOFT). Vaccine location was arm left. The patient experienced diarrhea on 29Dec2020 10:00, nausea on 29Dec2020 10:00. The action taken in response to the events for BNT162B2 was not applicable. Events outcome was not recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,SPRINTEC; ; SEROQUEL; ZOLOFT,,Medical History/Concurrent Conditions: Hemochromatosis; Latex allergy,,,"['Diarrhoea', 'Nausea']",1,PFIZER\BIONTECH,OT 920228,,,F,"ears are on fire; This is a spontaneous report from a contactable nurse (patient) received via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included diphenhydramine hydrochloride (BENADRYL, strength: 25 mg) at 75 mg for unspecified indication. It was reported that on 23Dec2020 the patient took BENADRYL 25 mg pre-vaccination and was given BENADRYL 50 mg post vaccination, the patient experienced ears are on fire on an unspecified date. The patient outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,,,UNK,BENADRYL,,,,,['Ear discomfort'],1,PFIZER\BIONTECH, 920229,KS,46.0,F,"chills; bad headache; body aches; She felt cold; Her arm felt so heavy; This is a spontaneous report from a contactable other health professional reporting for herself. A 46-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), intramuscular in arm right, on 28Dec2020 morning, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from the end of May2020 to unknown date in 2020 (not ongoing) and ongoing hypertension. Concomitant medication included losartan (LOSARTAN) from an unspecified date and ongoing, for hypertension. On 28Dec2020 evening, around 08:00 or 09:00 PM, the patient experienced chills with outcome of recovering, bad headache with outcome of not recovered, body aches with outcome of recovering, she felt cold with outcome of recovering, her arm felt so heavy with outcome of recovered in Dec2020. Therapeutic measures were taken as a result of bad headache and included laying down, ice on her back and neck. The second dose is scheduled on 18Jan2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,Hypertension,Medical History/Concurrent Conditions: COVID-19 (From the end of May2020.),,,"['Chills', 'Feeling cold', 'Headache', 'Limb discomfort', 'Pain']",1,PFIZER\BIONTECH,OT 920230,IN,50.0,F,"hives in her chest and neck; Her neck and chest were itchy; had a headache and was tired; had a headache and was tired; This is a spontaneous report from a contactable Other HCP reporting for herself. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685), via an unspecified route of administration in the right arm on 23Dec2020 12:00 at single dose for COVID-19 immunisation. Medical history included seasonal allergies to: Ragweed, bees, mold, trees, lots of seasonal things. The patient's concomitant medications were none. On 23Dec2020 the patient had a headache and was tired with outcome of unknown, the patient attributed it to having a stressful day. On 24Dec2020 (between 00:00 and 06:00), she had hives across her neck and part of chest. Her neck and chest were itchy and she had hives the next morning. The patient took diphenhydramine hydrochloride (BENADRYL) for 2 days for hives and was all better. She would like to know if she should get the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Allergic reaction to bee sting; Allergy to molds; Ragweed allergy; Seasonal allergy,,,"['Fatigue', 'Headache', 'Pruritus', 'Urticaria']",UNK,PFIZER\BIONTECH, 920231,PA,72.0,F,"arms hurting; Lymph nodes hurting on the left side; chills in which she is hot and cold and she couldn't get warm at first and then she is cold; high blood pressure/blood pressure was high 190/116; big toes hurting; nausea; dizziness; feeling weakness legs/Leg feeling weak; This is a spontaneous report from a contactable other HCP reporting for herself. A 72-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: CJ1686), via an unspecified route of administration in the right arm on 28Dec2020 15:00 at single dose for COVID-19 immunisation. Medical history included breast cancer on the left side, hypertension, hiatal hernia, glaucoma, heart disease, hypertension, lymphadenectomy (lymph nodes being taken out was about 20 years before) and headache from 27Dec2020. She was working Sunday into Monday morning and she went to the Director of Nursing, and said she has a Headache on the left side of the temple, and so she went to eye doctor, and he had a test order ESR and so she has a hemorrhage in the left eye, and show she doesn't know if this could be bringing on some of the side effects she was speaking about, like the nausea and the migraine. She has had No positive test for COVID prior to the vaccine, she must have had about 20 tests and all were negative. She has not had any Antibody tests. She had pneumonia vaccine maybe in the last 5-3 years and flu vaccine in Oct2020 and she experienced achy arm. On 28Dec2020 the patient experienced leg feeling weak (about 15 minutes after injection), nauseous at 21:00, dizziness. On 29Dec2020 the patient experienced arm hurting (in the morning), lymph nodes hurting on the left side, chills, blood pressure was high 190/116, big toes hurting. The patient was calling to ask if these side effects she was experiencing were normal. On 29Dec2020 the patient underwent ESR with unknown results. The patient reported that her arm hurting began on 29Dec2020 in the morning. The breast cancer diagnosis was prior to the vaccine as well as her lymph nodes being taken out was about 20 years ago. Her Lymph nodes hurting on the left side started on 29Dec2020 in the morning. Her Leg feeling weak started right after the injection, about 15 minutes after on 28Dec2020. The chills started on 29Dec2020 in the morning in which she couldn't get warm. Her feeling nauseous started on 28Dec2020 in the evening like 9 PM. The Temperature 98.1 was her current temperature taken right before the call, as well as her blood pressure. Her feeling dizzy started after getting vaccine on 28Dec2020, she was fine to drive home, but then again on 29Dec2020 in the morning she felt it also. Her legs felt funny like rubbery. The big toes hurting started an hour before, on 29Dec2020 it woke her up since it was jabbing. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,UNK,,,"Medical History/Concurrent Conditions: Breast cancer (she had breast cancer on the left side); Eye haemorrhage; Glaucoma; Headache (on the left side of the temple); Heart disease, unspecified; Hiatal hernia; Hypertension; Lymph node excision (her Lymph nodes being taken out was about 20 years ago)",,,"['Blood pressure measurement', 'Body temperature', 'Chills', 'Dizziness', 'Hypertension', 'Lymph node pain', 'Muscular weakness', 'Nausea', 'Pain in extremity', 'Red blood cell sedimentation rate', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 920232,VA,,F,"headache; myalgia/muscle pain; joint pain; sore arms; teeth pain; swollen face/face swelling; soft hypotension; could not barely open her mouth; barely ate; sick; allergic reaction; pain and facial fillers; This is a spontaneous report from a contactable nurse reporting for herself. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, myalgia/muscle pain, joint pain, sore arms, teeth pain, swollen face/face swelling, soft hypotension, could not barely open her mouth, barely ate, sick, allergic reaction, pain and facial fillers all on an unspecified date with outcome of unknown. The patient reported that she had a severe reaction with her first dose of the vaccine, she mentioned that never in her life she had experienced a reaction like that one, she presented the following symptoms: headache, myalgia, muscle pain, joint pain, sore arms, teeth pain and swollen face, pain and facial fillers, soft hypotension, face swelling so bad that she could not barely open her mouth, these reactions occurred 4 days after receiving the first dose of the vaccine. She barely ate because she was pretty sick from the side effects. She had to use steroids and antihistamines to counter the allergic reaction. The reporter wanted to know if she could be pre-administered with anti-inflammatory or another medication as a precaution prior to receiving her second dose of the vaccine. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Arthralgia', 'Dyskinesia', 'Eating disorder', 'Facial pain', 'Headache', 'Hypersensitivity', 'Hypotension', 'Illness', 'Myalgia', 'Pain in extremity', 'Swelling face', 'Toothache']",1,PFIZER\BIONTECH, 920233,NJ,,F,"like a little bit of adrenaline rush the rest of the couple of hours I was working; I felt my heart was racing so checked, and my heart rate (HR) was in the upper 90s-110; I felt my heart was racing so checked, and my heart rate (HR) was in the upper 90s-110/ It kept doing that on and off, on and off until HR got around 120 at 11pm last night.; itchy; This is a spontaneous report from a contactable Other HCP reported for herself. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 28Dec2020 for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient reported that she felt ok during the observation period (15 minutes) and like a little bit of adrenaline rush the rest of the couple of hours she was working. When she got home, she felt her heart was racing so checked, and her heart rate (HR) was in the upper 90s-110. Eventually it came down after hydrating herself. It kept doing that on and off, on and off until HR got around 120 at 11pm last night. Benadryl helped. She was itchy but her HR is back down to 76 and it seems that everything is clearing. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/01/2020,,UNK,,,,,,"['Feeling abnormal', 'Heart rate', 'Heart rate increased', 'Palpitations', 'Pruritus']",1,PFIZER\BIONTECH, 920234,CA,,M,"muscle aches; fatigue; nauseous/ almost vomiting; had a ""brain fog"" or was feeling unwell; had a ""brain fog"" or was feeling unwell; This is a spontaneous report from a contactable Other HCP reported for himself. A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on unknown date for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 1 day after getting the vaccine the patient experienced muscle aches and fatigue. Then on Sunday, he was nauseous, ""almost vomiting,"" had a ""brain fog"" or was feeling unwell. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Fatigue', 'Feeling abnormal', 'Malaise', 'Myalgia', 'Nausea']",UNK,PFIZER\BIONTECH, 920235,PA,36.0,F,"Injection site is moderately swollen and moderately painful; Injection site is moderately swollen and moderately painful; Range of motion is affected; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (Lot Number: EK5730), via an unspecified route of administration in right arm, on 28Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included seasonal allergies, and allergies to sulfa, kiwi, sunflower seeds, and herbal tea. The patient's concomitant medications included paracetamol (TYLENOL), loratadine (CLARITINE), ibuprofen (ADVIL), famotidine (PEPCID), ergocalciferol (VIT D), and ascorbic acid (VIT C). The patient previously took oseltamivir phosphate (TAMIFLU) and nickel and experienced allergies to both. No other vaccine was administered in four weeks. On 29Dec2020 at 11:00 AM, the injection site was moderately swollen and moderately painful and the patient's range of motion was affected (pending clarification). The patient was reporting this because she had never in her life had injection site swelling. The site was not itchy or red. There was no rash. It's just markedly swollen and painful. No treatment was given for the adverse events. The patient did not have COVID-19 prior to vaccination and the patient did not test for COVID-19 post-vaccination. The patient had not recovered from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,TYLENOL; CLARITINE; ADVIL [IBUPROFEN]; PEPCID [FAMOTIDINE]; VIT D; VIT C,,Medical History/Concurrent Conditions: Food allergy; Seasonal allergy; Sulfonamide allergy,,,"['Joint range of motion decreased', 'Vaccination site pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 920236,,,F,"patient received the first dose of COVID 19 vaccine on 16Dec2020. She got tested positive on 20Dec2020; patient received the first dose of COVID 19 vaccine on 16Dec2020. She got tested positive on 20Dec2020; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of COVID 19 vaccine on 16Dec2020. She got tested positive on 20Dec2020. The patient wanted to know if it's safe for her to get the second dose of covid-19 vaccine scheduled for 07Jan2021. Outcome of the event was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/20/2020,4.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 920237,AZ,,F,"having short term memory/can not recall things from 2 months ago; soreness in arm; This is a spontaneous report from a contactable Physician. A female patient (Reporter's wife) of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on unknown date for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 29Dec2020 the patient experienced soreness in arm and at 4 o'clock pm she having short term memory, cannot recall things from 2 months ago. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/29/2020,,UNK,,,,,,"['Memory impairment', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 920238,,29.0,M,"Nausea; Chills; Injection site pain; Tingling in his arm; This is a spontaneous report from a non-contactable pharmacist. A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140), via intramuscular, on 28Dec2020 at 13:15, at single dose for COVID-19 immunisation. Vaccine location was left arm. No relevant medical history and concomitant medications were provided. The patient was vaccinated at workplace clinic, age at vaccination was 29-year-old. No other vaccine was received in four weeks. On 29Dec2020, the patient reported normal side effects of nausea, chills, injection site pain. Patient also reported that he was experiencing tingling in his arm. No therapeutic measures were taken as result of the events. Pre-vaccination and post-vaccination COVID tests were not performed. The patient had not recovered from the events. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,WRK,,,,,,"['Chills', 'Nausea', 'Paraesthesia', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 920239,,,M,"anaphylactic shock/numb throat; high heart rate; light headed; anaphylactic shock/numb throat; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age (reported as 39: unknown unit) received bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 22Dec2020 at single dose, for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylactic shock, numb throat, high heart rate and light headed on an on 22Dec2020. The outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,UNK,,,,,,"['Anaphylactic shock', 'Dizziness', 'Heart rate increased', 'Pharyngeal hypoaesthesia']",UNK,PFIZER\BIONTECH, 920240,,,F,"pain; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain (non-serious) on an unspecified date. Therapeutic measures taken as a result of pain included 3 ADVIL. Caller reported taking 3 advil after receiving vaccine due to pain not related to vaccine, her pain was related to swimming. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently provided, a possible contributory role of vaccination with BNT162B2 in the development of the event pain cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain'],UNK,PFIZER\BIONTECH, 920241,WA,48.0,F,"Rhinorrhea; This is a spontaneous report from a contactable nurse. A 48-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular (arm left) on 23Dec2020 17:00 at single dose for Covid-19 immunization. The patient's medical history included obese and seasonal allergies. Concomitant medications included ibuprofen, acetaminophen, loratadine, calcium, vitamin c (ASCORBIC ACID), vitamin d3, probiotics, and fish oil. The patient previously took Nickel and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rhinorrhea on 23Dec2020 (21:00). There was no treatment received for the adverse event. The outcome of event was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,; ACETAMINOPHEN; ; ; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; ;,,Medical History/Concurrent Conditions: Obesity; Seasonal allergy,,,['Rhinorrhoea'],1,PFIZER\BIONTECH,OT 920242,MI,39.0,F,"Rash on form arms; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), at the age of 39-year-old, via an unspecified route of administration on 23Dec2020 at 02:30 at a single dose on the right arm for Covid-19 immunization. Medical history included diabetic type 1. Concomitant medications included insulin aspart (NOVOLOG) and levothyroxine sodium (SYNTHROID). The patient experienced rash on ""form arms"" on 28Dec2020 at 07:00. The patient received diphenhydramine hydrochloride (BENADRYL) as treatment for the event. Outcome of the event was recovering. The event was assessed as non-serious by the reporter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/28/2020,5.0,PUB,NOVOLOG; SYNTHROID,,Medical History/Concurrent Conditions: Type 1 diabetes mellitus,,,['Rash'],1,PFIZER\BIONTECH, 920243,MO,55.0,F,"Nausea; Vomiting; Headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 at single dose in right upper arm for COVID-19 immunisation. Medical history was none. There were no concomitant medications. On 29Dec2020 the patient experienced nausea, vomiting and headache: patient worked at the hospital; 30-45 minutes after she received the vaccine, she got really nauseated. She was also vomiting and had a headache. She has stopped vomiting on 29Dec2020 (30 min before the report). Events were all non-serious. Patient recovered from vomiting on 29Dec2020; outcome of nausea and headache was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Headache', 'Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH, 920244,,,F,"soreness; tiredness; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced soreness and tiredness on an unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Fatigue', 'Pain']",UNK,PFIZER\BIONTECH, 920245,,,M,"Experienced mild local site injection pain; This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 36 year-old male patient received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced mild local site injection pain on an unspecified date with outcome of unknown. No follow-up attempts are possible. Information about lot/Batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination site pain'],UNK,PFIZER\BIONTECH, 920246,TX,,M,"generalized pain/generalized body aches; shortness of breath; chills; sick; fever; feeling run down; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced generalized pain/generalized body aches, shortness of breath, chills, sick, fever, and feeling run down; all on 28Dec2020. The reporter didn't know if the patient had tested positive for COVID after receiving the COVID vaccine. This patient was not in the hospital at time of reporting. The outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['Chills', 'Dyspnoea', 'Fatigue', 'Illness', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 920247,IN,,M,"tested positive for COVID-19; tested positive for COVID-19; feeling sick; This is a spontaneous report from a consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. On 24Dec2020 the patient was sick and was tested positive for covid-19, the outcome of the event was unknown. Information about Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/24/2020,2.0,UNK,,,,,,"['Malaise', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 920248,,,U,"Swollen lymph nodes on my neck; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration in Dec2020 at single dose in arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer Vaccine last Tuesday in Dec2020 and today in Dec2020 the patient woke up with swollen lymph nodes on the neck, opposite side where the arm was injected. The outcome was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,['Lymphadenopathy'],UNK,PFIZER\BIONTECH, 920249,CO,28.0,F,"Nausea; racing heart rate; restlessness; Dizziness; Shaking; breathlessness; This is a spontaneous report from a contactable consumer reporting for herself. A 28-years-old female patient received bnt162b2 (BNT162B2 ; Lot # EK9231) vaccine , via an unspecified route of administration on 27Dec2020 at single dose for Covid-19 immunisation . Medical history included drug hypersensitivity to amoxicillin sodium on an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced about one minute and a half after receiving the vaccine racing heart rate on 27Dec2020 with outcome of recovered , restlessness on 27Dec2020 with outcome of recovered , dizziness on 27Dec2020 with outcome of recovered , shaking on 27Dec2020 with outcome of recovered , breathlessness on 27Dec2020 with outcome of recovering , nausea on 28Dec2020 with outcome of recovered. The patient underwent lab tests and procedures which included heart rate: racing on 27Dec2020. The patient received diphenhydramine (BENADRYL) to treat dyspnea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Dizziness', 'Dyspnoea', 'Heart rate', 'Heart rate increased', 'Nausea', 'Restlessness', 'Tremor']",UNK,PFIZER\BIONTECH, 920250,,,U,"I am like itchy all over in my the body; Rash; This is Spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer vaccine for COVID earlier on 29Dec2020 and few hours past, the patient got at around 3 O'clock and then at time of the report the patient was like itchy all over in the body and the patient had like rashes. The outcome of the events was unknown. No follow-up attempts are possible. Information on lot/batch cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,UNK,,,,,,"['Pruritus', 'Rash']",UNK,PFIZER\BIONTECH, 920251,GA,25.0,F,"dehydration; Headache; nausea; vomiting; This is a spontaneous report from a contactable physician. A 25-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, lot number: EL0142), intramuscularly at site of right arm on 28Dec2020 at single dose for COVID-19 immunization. Age at vaccination was 25-year-old. Medical history included COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient's concomitant medications were not reported. The patient experienced headache, nausea, vomiting, dehydration on 29Dec2020. Events were resulted in emergency room/department or urgent care. The patient received treatment (IV fluids, ondansetron (ZOFRAN), metoclopramide (REGLAN)) for the adverse event. Facility where the most recent COVID-19 vaccine was administered in hospital. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,,,"Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19)",,,"['Dehydration', 'Headache', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,OT 920252,IL,29.0,F,"some redness was noted at injection site; Pain at injection site; This is a spontaneous report from a contactable Physician (patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot number: EL0140), intramuscular in Left arm on 24Dec2020 at 11:45 am at single dose for COVID-19 immunisation . Medical history was none.No known allergies to medications, food, or other products. There were no concomitant medications. On 24Dec2020 at 10:00 pm (as reported) the patient experienced pain at injection site and on 25Dec2020 some redness was noted at injection site; events were reported as non-serious and described as follows: pain at injection site, started 10 hours after vaccination (as reported), lasted 24 hours. Also some redness was noted at injection site a day after vaccination, that self resolved in 2 days. Patient did not need to take any pain medication, no treatment given for the events. Patient recovered from the events in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Vaccination site erythema', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 920253,AZ,56.0,F,"Headache; Chills; just really tired; achy; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (BNT162B2; reported as Covid Vaccine Pfizer; batch/lot number: EH9899; expiration date: 31Mar2021), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 vaccination. Medical history included AFib (atrial fibrillation), high blood pressure and has 25 percent of her colon. The patient's concomitant medications were not reported. The patient reported that she a Pfizer shot yesterday (28Dec2020) which was clarified as Covid Vaccine Pfizer and today (29Dec2020) she was having some reactions to it, but they are not serious. The patient mentioned that she has like a headache and some chills and something like that which she hoped would go away by tomorrow (30Dec2020) and hoping that it doesn't last long. The patient mentioned that this was her first dose. When inquired on treatment, the patient mentioned that she was just really tired and achy and was just going to try sleep. The patient underwent lab tests and procedures which included Covid Rapid testing every single week [unspecified date] but no results were provided and last time she was tested was on last Tuesday (22Dec2020) with negative results. The outcome of the event headache and chills were not recovered while the outcome of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,,,UNK,,,Medical History/Concurrent Conditions: Atrial fibrillation (Verbatim: AFib); Colectomy partial; Hypertension (Verbatim: High Blood Pressure),,,"['Chills', 'Fatigue', 'Headache', 'Pain', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 920254,,,F,"throat pain; increase body temperature; feels has something in throat; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 28Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. After getting the vaccine on 28Dec2020, the patient asked if it is okay to get tested for Covid or if it might result in false positive. The patient reported that she has throat pain, increase body temperature and feels has something in her throat and keeps swallowing to clear it. She felt it yesterday (29Dec2020) and now is okay, only her throat was hurting. The outcome of event throat pain was not recovered, while the outcome of other events was recovered on an unspecified date. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,UNK,,,,,,"['Body temperature', 'Body temperature increased', 'Oropharyngeal pain', 'Sensation of foreign body']",UNK,PFIZER\BIONTECH, 920255,AZ,30.0,M,"Headaches; This is a spontaneous report from a contactable Nurse (patient). A 30-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 at 13:30 at single dose in left arm for COVID-19 immunisation. Medical history included COVID-19 on an unknown date (prior to vaccination the patient was diagnosed with COVID-19). Since the vaccination, the patient was not tested for COVID-19. No known allergies to medications, food or other products. There were no concomitant medications. The patient experienced headaches on 29Dec2020 at 05:00 am. Event was non serious . No treatment given and patient recovered from the event in Dec2020. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,,,Medical History/Concurrent Conditions: COVID-19 (prior to vaccination),,,"['Headache', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 920256,CA,,F,"Some flu symptoms; heavy; taste at the back of her throat; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) via an unspecified route of administration on an unspecified date in Dec2020 at a single dose for Covid-19 immunisation; and naproxen (NAPROSYN) via an unspecified route of administration on an unspecified date in Dec2020 at 2 dosage forms (DF) to prevent symptoms you could get with the vaccine. The patient's medical history and concomitant medications were not reported. The patient reported that she received her first vaccine last night but two hours before, she took two naproxen to try to prevent the symptoms she heard you could get with the vaccine. She did feel some flu symptoms and heavy and a taste at the back of her throat. She was concerned that the naproxen may have had a negative effect on the vaccine. She wanted to know if there were any information. Outcome of the events were unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Discomfort', 'Dysgeusia', 'Influenza']",UNK,PFIZER\BIONTECH, 920257,TX,,F,"antibody/antigen testing; received vaccine on Monday then tested positive last night; This is a spontaneous report from a contactable pharmacist (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date in Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called about antibody/antigen testing. She tested negative on Sunday (Dec2020), received vaccine on Monday (Dec2020) then tested positive last night (Dec2020). She wanted to know if she truly has Covid or if it positive due to the vaccination. She gets tested every three day because she works in a long-term care facility. Outcome of the event was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['SARS-CoV-2 antibody test', 'SARS-CoV-2 antibody test positive']",UNK,PFIZER\BIONTECH, 920258,,,F,"I developed a bitter taste; I am not able to eat; I felt so bad; I started coughing; I feel so sick and helpless; This is a spontaneous report from a contactable consumer (the patient), a front line worker. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/Lot number unknown, via an unspecified route of administration on 17Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Dec2020, a moment after vaccination, the patient experienced a bitter taste, was not able to eat, felt so bad, started coughing, felt so sick and helpless. The events were non-serious with outcome of unknown. The information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['Cough', 'Dysgeusia', 'Feeding disorder', 'Feeling abnormal', 'Malaise']",UNK,PFIZER\BIONTECH, 920259,NJ,,F,"headache; redness, soreness and itchiness on her arm that lasted a week; redness, soreness and itchiness on her arm that lasted a week; redness, soreness and itchiness on her arm that lasted a week; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (reported as Age: 51; Unit: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on 19Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. For the first two days (on 21Dec2020) she had a headache, treated with paracetamol (TYLENOL) and headache went away. Then she developed redness, soreness and itchiness on her arm in Dec2020 that lasted a week. This week these side effects have been more intermittent. She queried if it was okay to receive second dose on 08Jan2021. The patient recovered from the events in Dec2020. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/01/2020,,UNK,,,,,,"['Erythema', 'Headache', 'Pain in extremity', 'Pruritus']",1,PFIZER\BIONTECH, 920261,RI,62.0,F,"Left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear; Left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear; Also felt a little stiffness in that neck area; This is a spontaneous report from a contactable nurse, the patient. A 62-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EH9899) via an unspecified route of administration, in the left arm, on 19Dec2020 at 07:00 AM (at the age of 62-year-old) as a single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included fish oil (OMEGA 3 FISH OIL), calcium carbonate, colecalciferol (VITAMIN D 2000). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Dec2020, at 08:00 AM, the patient experienced left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear, she also felt a little stiffness in that neck area. The neck pain lasted 24 hours. The events were reported as non-serious. The patient did not receive any treatment for left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear, she also felt a little stiffness in that neck area. The clinical outcome of the events left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear, she also felt a little stiffness in that neck area was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/20/2020,1.0,PVT,OMEGA 3 FISH OIL [FISH OIL]; VITAMIN D 2000,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Ear pain', 'Musculoskeletal stiffness', 'Neck pain']",1,PFIZER\BIONTECH, 920262,CO,20.0,F,"Redness and warmth around injection site 5-6 hours after receiving vaccine; Redness and warmth around injection site 5-6 hours after receiving vaccine; soreness 2 hours after administration until currently; This is a spontaneous report from a contactable healthcare professional, the patient. A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection in the left arm on 29Dec2020 at 17:30 (at the age of 20-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included asthma. Concomitant medications included clonidine, lamotrigine (LAMICTAL), ethinylestradiol/etonogestrel (NUVARING) and bupropion hydrochloride (WELLBUTRIN). The patient did not have allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 29Dec2020, the patient experienced redness and warmth around injection site 5-6 hours after receiving vaccine and soreness 2 hours after administration until currently. No treatment was provided for the events redness and warmth around injection site and soreness. The outcome of the events redness and warmth around injection site was recovering. The outcome of the event soreness 2 hours after administration was not recovered. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,; LAMICTAL; NUVARING; WELLBUTRIN,,Medical History/Concurrent Conditions: Asthma,,,"['Pain', 'Vaccination site erythema', 'Vaccination site warmth']",1,PFIZER\BIONTECH, 920263,,35.0,F,"Nausea; body aches; headache; unable to sleep; This is a spontaneous report from a non-contactable nurse, the patient. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number Eh9899) solution for injection in the left arm on 29Dec2020 at 14:00 (at the age of 35-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included asthma, pituitary adenoma, IBS (irritable bowel syndrome) and COVID (prior to vaccination). Concomitant medications were unknown. Past drug history included known allergies: ciprofloxacin hydrochloride (CIPRO). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. In Dec2020, the patient experienced nausea, body aches, headache and unable to sleep. No treatment was provided for the events nausea, body aches, headache and unable to sleep. The outcome of the events nausea, body aches, headache and unable to sleep was recovering. Since the vaccination, the patient has been tested for COVID-19 via nasal swab on 30Dec2020 and result was pending. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/01/2020,,MIL,,,Medical History/Concurrent Conditions: Asthma; COVID-19 (prior to vaccination); Irritable bowel syndrome; Pituitary adenoma,,,"['Headache', 'Insomnia', 'Nausea', 'Pain', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 920264,CA,29.0,F,"Left hand feels sleepy; This is a spontaneous report from a contactable health care professional nurse, the patient. A 29-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730), intramuscular in the left arm on 30Dec2020 at 14:00 as a single dose, for COVID-19 vaccination. The patient had no known medical history or allergies. Concomitant medication included amoxicillin (AMOXICILLIN). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 30Dec2020 at 16:45, the patient experienced left hand feels sleepy. No Treatment was given for the event. The clinical outcome of left hand feels sleepy was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Hypoaesthesia'],1,PFIZER\BIONTECH,OT 920265,NC,51.0,F,"swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ek5730, via an unspecified route of administration on 30Dec2020 at 12:00 (at the age of 51 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included lupus from an unknown date, and allergy to Celebrex (itching). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL), levothyroxine, vitamin D3, and zinc, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 30Dec2020 at 14:30, the patient experienced swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands. The patient received treatment for the events which included Pepcid, Benadryl and prednisone. The clinical outcome of swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; ; VITAMIN D3;,,Medical History/Concurrent Conditions: Lupus syndrome,,,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia', 'Sensation of foreign body', 'Swelling face']",1,PFIZER\BIONTECH, 920266,PA,65.0,F,"swollen arm swollen shoulder and swollen clavicle; lymphadenopathy; hands swelled, were red and itchy/swollen arm swollen shoulder and swollen clavicle; body rash to her arms, legs, abdomen with bubbly, clear bumps the size of a pea; hands swelled, were red and itchy; hands swelled, were red and itchy; This is a spontaneous report from a contactable nurse, the patient. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 17Dec2020 (at the age of 65 years old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 18Dec2020, the patient experienced hands swelled, were red and itchy, she took a shower and then experienced a ""body rash to her arms, legs, abdomen with bubbly, clear bumps the size of a pea, as well as lymphadenopathy"". The next day (19De2020) she started having a ""swollen arm swollen shoulder and swollen clavicle"". The clinical outcome of ""body rash to her arms, legs, abdomen with bubbly, clear bumps the size of a pea, as well as lymphadenopathy"" and ""swollen arm swollen shoulder and swollen clavicle"" was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/18/2020,1.0,UNK,,,,,,"['Erythema', 'Joint swelling', 'Lymphadenopathy', 'Peripheral swelling', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH, 920267,NM,,U,"having a little bit of like a flu, don't know if it's like a cold; having a little bit of like a flu, don't know if it's like a cold; This is a spontaneous report from a contactable consumer, the patient. This patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) via an unspecified route of administration on 17Dec2020 as a single dose for COVID-19 vaccination. The patient's medical history was not reported. On an unspecified date in Dec2020, the patient experienced having a little bit of like a flu, don't know if it's like a cold. Limited information was available. The clinical outcome of the flu like illness and a cold was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/01/2020,,UNK,,,,,,"['Influenza like illness', 'Nasopharyngitis']",UNK,PFIZER\BIONTECH, 920268,CA,,F,"Rash; Inflammation; Swelling; Itchy; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer, the patient. This female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 vaccination. The patient's medical history and concomitant medication were not reported. On an unspecified date, the patient experienced a rash, inflammation, swelling and itchy after receiving the vaccine. She stated it was not uncommon for her to get. The patient wanted to know if she could take a Benadryl. Limited information was available. The clinical outcome of rash, inflammation, swelling and itchy was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Inflammation', 'Pruritus', 'Rash', 'Swelling']",UNK,PFIZER\BIONTECH, 920269,,,F,fever of 101.8 (unit not reported); This is a spontaneous report from a contactable consumer reported for herself. This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a fever of 101.8 (unit not reported) that initially did not improve with aspirin or Tylenol. Temperature is currently 100.6. The outcome of event was unknown. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,,,UNK,,,,,,"['Body temperature', 'Pyrexia']",UNK,PFIZER\BIONTECH, 920270,,,F,"weakness; This is a spontaneous report from a contactable consumer. An 88-year-old female patient to received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified at a single dose for covid-19 immunisation, apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date and ongoing at an unknown dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced weakness. It was further reported that patient got the first shot scheduled to get the second on 08Jan2020. The patient had weakness from the shot and would like to known how long will the weakness last. The action taken in response to the event for apixaban was dose not changed. The outcome of the event was unknown. Information about lot/batch number is requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Asthenia'],UNK,UNKNOWN MANUFACTURER, 920271,,,F,"Little cough; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 20Dec2020 to 20Dec2020 single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced little cough on an unspecified date. The action taken in response to the event for BNT162B2 was not applicable. The outcome was recovered Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,,,UNK,,,,,,['Cough'],UNK,PFIZER\BIONTECH, 920274,SC,45.0,F,"Relapse of MCD; frothy urine; periorbital edema; 24 hour proteinuria was 1.5 gram; Initial information was received on 24-Dec-2020 regarding an unsolicited valid serious case from the other healthcare professional issued from a literature article. This case involved a 45-year-old female patient who had relapse of MCD (Minimal Change Disease) (glomerulonephritis minimal lesion) with frothy urine (urine abnormality), periorbital edema (periorbital oedema) and her 24 hour protein urine was 1.5 gram (proteinuria), after she received INFLUENZA VACCINE. The patient's medical history included abrupt onset of bilateral hand, facial, lower extremity edema and frothy urine and she was diagnosed with MCD after kidney biopsy on an unknown date of Dec-2014 (ongoing). Urinalysis (UA) showed 3+ protein and urine protein to creatinine (UPCR) was 6.5. Serum albumin was 1.5 g/dL (grams per deciliter), total cholesterol 465 mg/ dL, WBC (white blood cell) 6.79 K/mm (1000 per millimeter), hemoglobin (Hgb) 14.5 g/dL, platelets 417 K/mm, BUN (blood urea nitrogen) 20 mg/ dL, creatinine 1.0 mg/dL, AST (Aspartate Aminotransferase ) 29 iU/L (International units per liter), ALT (Alanine Transaminase) 20 iU/L, C3 (complement component 3) 155 mg/dL and C4 29.3mg/dL. RPR (Rapid Plasma Reagin), hepatitis B & C serologies, and ANA (Antinuclear Antibody) were negative. After approximately 2 weeks, UPCR worsened to 12 g/g. The patient's past medical treatment included oral prednisone 1mg/kg (milligram per kilogram) daily, torsemide with 5mg/day and rosuvastatin with 5mg/day for MCD. Complete remission of proteinuria was documented 2 weeks later and persisted after completing a 6-month course of prednisone. The patient had no other significant medical or allergy history and no signs of systemic infection. She was normotensive and she denied recent infections or use of NSAID (Nonsteroidal anti-inflammatory drugs). The patient's past vaccination(s), family history and concomitant medication were not reported. The patient remained in complete remission until Oct-2016. On an unknown date of Oct-2016, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination. On an unknown date of 2016, the patient experienced serious relapse of MCD in the absence of other potential triggers of MCD(glomerulonephritis minimal lesion) with frothy urine (urine abnormality), periorbital edema (periorbital oedema) and her 24-hour protein urine was 1.5 gram (proteinuria), just after administration of INFLUENZA VACCINE. These events were assessed as medically significant. The patients renal and hepatic chemistries were normal with creatinine 0.7 mg/dL except for serum albumin of 3.0 g/dL. UA showed protein 100 mg/dL. The patient was treated with oral Prednisone 50mg/day from an unknown date of 2016. The patient had recovered from proteinuria within 21 days after treatment with Prednisone and at the time of reporting, outcome was not reported for other events. It was reported that, this case as well as previous anecdotal reports suggested that influenza vaccination and the resulting stimulation of the immune system may cause MCD. There will be no information available on the batch number for this case.; Sender's Comments: This case concerns 45-year-old patient who presented with relapse of glomerulonephritis minimal lesion, just after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is compatible. However, the patient already had same events before vaccination and information regarding past vaccination, its tolerance and concomitant medications were needed to fully assess the case. Based upon the reported information, the role the vaccine cannot be assessed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,10/01/2016,,,UNK,,Minimal change disease,"Medical History/Concurrent Conditions: Face edema; Foamy urine; Peripheral swelling; Proteinuria (Complete remission of proteinuria was documented 2 weeks later.); Comments: The patient had no significant medical or allergy history and no signs of systemic infection. She was normotensive. Urinalysis (UA )showed 3+ protein and urine proteinto-creatinine(UPCR) was 6.5 g/g. Serum albumin was 1.5g/dL,total cholesterol 465 mg/ dL, WBC 6.79K/mm ,hemoglobin (Hgb) 14.5 g/dL, platelets 417K/mm ,BUN 20 mg/ dL, creatinine 1.0 mg/dL, AST 29IU/L,ALT 20 IUL/L, C3 155mg/dL, and C4 29.3mg/dL. RPR, hepatitis B & C serologies, and ANA were negative. After approximately 2 weeks, UPCR worsened to 12 g/g. A kidney biopsy showed MCD.",,,"['Blood albumin decreased', 'Blood creatinine normal', 'Condition aggravated', 'Glomerulonephritis minimal lesion', 'Laboratory test normal', 'Periorbital oedema', 'Protein urine present', 'Proteinuria', 'Urine abnormality']",UNK,UNKNOWN MANUFACTURER,OT 920275,,24.0,F,"seizure; high fever; Initial information was received on 29-Dec-2020 regarding an unsolicited valid serious case from a consumer(patient) via other company. This case involves a 24-year-old female patient who experienced seizure and high fever (pyrexia), while she received TETANUS TOXOID, DIPHTHERIA TOXOID, TYPHOID VACCINE and CHOLERA VACCINE. Medical history, medical treatment, concomitant medications, vaccination and family history were not provided. At the time of the event, the patient had ongoing latex allergy (Rubber sensitivity) and injectable Iodine allergy. On an unknown date, the patient received a dose of each suspect TYPHOID VACCINE produced by unknown manufacturer and suspects DIPHTHERIA TOXOID, TETANUS TOXOID and CHOLERA VACCINE not produced by Sanofi Pasteur (lot number and expiry date not reported) all vaccines via unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious seizure and high fever (pyrexia) 6 hours following the administration of TYPHOID VACCINE, DIPHTHERIA TOXOID, TETANUS TOXOID and CHOLERA VACCINE. The patient was hospitalized for this event. (hospitalization duration 4 days). The event seizure was assessed as medically significant. It was reported that, the patient having previous reactions to vaccines when she was 24 years old prior to trip and doctors told during hospitalization that she should not have received all four vaccines at the same time. Reporter asked if she can receive the COVID-19 vaccine, she also told that (this whole thing has been a waste of her time). Other relevant laboratory data not reported. It was not reported if the patient received any corrective treatment. At the time of report, the outcome was unknown for both the events. Information on the lot number was requested.; Sender's Comments: This case concerns a 24-year-old female patient who experienced seizure and pyrexia after vaccination with TETANUS TOXOID, DIPHTHERIA TOXOID, TYPHOID VACCINE and CHOLERA VACCINE. The time to onset is compatible. The patient has allergies to latex and injectable iodine. Further information regarding medical condition at the time of vaccination, previous vaccinations and laboratory investigations excluding alternative etiologies is needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,,,,UNK,,Iodine allergy; Latex allergy,,,,"['Pyrexia', 'Seizure']",UNK,UNKNOWN MANUFACTURER,OT 920276,MA,,F,"angioedema; arm swelled up; Initial information regarding an unsolicited valid serious case was received from a consumer (patient) on 28-Dec-2020. This case involves female patient of an unknown age who experienced arm swelled up (peripheral swelling) and angioedema, while she received vaccine INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE]. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown. On 30-Sep-2013, the patient received suspect INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [lot number: UH894AB and expiration date: unknown] at an unknown dose and frequency via unknown route and unknown site for prophylactic vaccination. On an unknown date, (latency unknown) patient had a reaction as the arm swelled up (peripheral swelling). Patient was on a lot of vitamin D and then got the vaccines; that she had angioedema but had not had it in a few years. The event angioedema was assessed as medically significant as per important medical event (IME) list. It was not reported if the patient received a corrective treatment. The outcome of the both events was unknown. There will be no information available regarding batch number in this case.; Sender's Comments: This case concerns a patient of unknown age who experienced swelling of her arm and had angioedema after vaccination with FLUZONE. The time to onset is unknown. Moreover, there is no information on patient's allergic history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,09/30/2013,,,UNK,,,,,,"['Angioedema', 'Condition aggravated', 'Peripheral swelling']",UNK,SANOFI PASTEUR,OT 920278,OH,41.0,F,"Total body aches and chills, followed by 101.2 fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,"Celebrate, sythroid, Celexa, Allegra, iron",no,"hypothyroid, pcos",,"pcn, scallops","['Chills', 'Pain', 'Pyrexia']",1,MODERNA,IM 920279,WI,23.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,['Product storage error'],1,MODERNA,IM 920281,WI,34.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,['Product storage error'],1,MODERNA,IM 920282,FL,77.0,M,Moderate persistent headaches which began several days post vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/27/2020,5.0,OTH,"Xarelto, Aldactazide/HCTZ, Lisinopril, Amlodipine, Cardevilol, Omeprazole, Atorvastatin, Trazadone, Montelukast Sod, Folic Acid, Fish Oil, Magnesium, Ocular Vitamin",None,"History: HBP, Atrial Fib",,Penicillin??,['Headache'],UNK,PFIZER\BIONTECH, 920283,MA,25.0,M,"Fever, immune response due to covid-19, I believe from being sick with covid recently",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,None,Tested positive for Covid-19 on December 10th,None,,None,['Pyrexia'],1,MODERNA,IM 920284,IA,64.0,F,"Day 9 post-vaccine, employee developed a raised, red patch around injection site, approximately 3 inches wide by 5 inches long. The area is not warm or painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,WRK,,,,,,"['Injection site erythema', 'Injection site reaction', 'Rash papular']",1,MODERNA,IM 920285,WI,45.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,amoxicillin,['Product storage error'],1,MODERNA,IM 920286,OH,46.0,F,"11 hours after injection: Pain and swelling at injection site. Blister at injection site. Itching of arm of injection site. 13 hour after injection: Chills and muscle aches 20 hour after injection: Fever (101.4 - 101.7), Nausea, Vomiting, Muscle cramping, diarrhea. Symptoms persisted 48 hours, until about 72 hours after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Prempro,,,,Sulfa,"['Chills', 'Diarrhoea', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site vesicles', 'Muscle spasms', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 920287,CT,48.0,F,Approximately 20 minutes after vaccination developed burning sensation in sternum. States non radiating. Felt similar to heartburn. Persistent. No SOB. No changes to pain with deep breathing. Approximately 445 mins post vaccination developed dizziness as well. Patient was seen in clinic and EKG performed. Noted to be SR. Vital signs stable. Patient sent via EMS to local hospital for full workup.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,MIL,Meloxicam. Topomax. NSAIDs PRN. Lexapro,"Hx. of currently being worked up by rheumatologist for unknown ""viral inflammatory condition""","Depression. Anxiety. Reflux. Fibrocystic disease. Sciatica. Migraines. Asthma. Obesity. Vocal cord paralysis. TE paralysis. ""Viral inflammatory condition"". Dizzy spells. ""Something wrong with my inner ear"".",,Codeine,"['Burning sensation', 'Condition aggravated', 'Dizziness', 'Electrocardiogram normal', 'Sinus rhythm']",1,MODERNA,IM 920289,MI,26.0,M,"24 hours after administration started having fever up to 101.5, chills, body aches, headache. Fever and chills lasted about 12 hours. Headache and body aches continue past 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,PVT,Bupropion Omeprazole Cetirizine,None,Depression GERD,,None,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 920290,MD,54.0,F,Painful swollen lymph nodes collar bone and underarm of Left side. Started 1/2 Injection site raised lumpy and itchy started 1/4 Raised itchy rash on R hip started 12/31.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,WRK,Lisinopril 5mg daily Vit c 1500mg daily Vit D 2000units daily Magnesium 400mg daily Vit b12 50mcg daily,Sinus infection 1onth prior,Sinusitis HTN,,Sulfa and avelox,"['Injection site mass', 'Injection site pruritus', 'Lymph node pain', 'Lymphadenopathy', 'Pruritus', 'Rash', 'Rash papular']",1,MODERNA,IM 920291,WI,59.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 920293,FL,38.0,F,"Nausea, bloating, gas, and pain at the injection site. Nausea set in 3 hours after injection and lasted about 36 hours. Bloating and gas continue day 3. Pain set in 10 hours after injection and lasted 24 hours. No medical attention needed, tea, soup, fluids, moving the arm, and rest helped.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,OTH,"Montelukast 10 mg Cetirizine 10mg Flucticasone 50mcg B12 100mcg Multi Collagen Joint support (glucosamine 1500, chondroitin 1200, MG MSM 1000) Multi stran probiotic",,,,"Dust, cockroaches, Bahia, pine, dogwood, nettle","['Abdominal distension', 'Flatulence', 'Injection site pain', 'Nausea']",1,PFIZER\BIONTECH,IM 920294,FL,42.0,M,Moderate soreness at injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,None,None,None,"Tetanus, moderate fever that lasted 12 hours.",erythromycin,['Injection site pain'],UNK,MODERNA,IM 920295,GA,58.0,F,"coughing shortly after injection, lasted a few minutes but went away. Benadryl given",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,,,,,,['Cough'],1,MODERNA,IM 920296,WI,53.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,meperidine,"['No adverse event', 'Product storage error']",1,MODERNA,IM 920297,IL,63.0,F,Swollen painful eyes,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/04/2021,1.0,UNK,None,None,Asthma,Flu,"Sulfa, cephalosporins","['Eye pain', 'Eye swelling']",UNK,MODERNA, 920298,MI,54.0,F,"Vaccine at 8:40 am. 1 pm same day started with headache that progressed to severe headache. Marked pain in injection sight that radiated to neck and all the way to fingers. injection sight Felt warm, moderate swelling, not red. pain in arm lasted 2.5 day. Also Severe arthalgias and myalgia all over. Extreme fatigue, Foggy head. Blurry vision mild 48 hr. Very aggitated. Slept more but disturbed sleep. Could not work 24 hr. Very tired at work 12/31/2020. Naueas, no vomiting, mild constipation. Patient still feels tired and foggy today 1/5/2021 but improving",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,occasional tylenol or ibuprofen. Take multivitamin,no. Did donate one unit of blood the day before,none,,nausea to codeine not true allergy,"['Agitation', 'Arthralgia', 'Constipation', 'Fatigue', 'Feeling abnormal', 'Headache', 'Hypersomnia', 'Impaired work ability', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Myalgia', 'Nausea', 'Neck pain', 'Pain', 'Pain in extremity', 'Sleep disorder', 'Vision blurred']",1,MODERNA,IM 920299,VA,27.0,F,"Saturday night headache took Tylenol, Sunday body aches chills headache dizzy nauseous weak, Monday vomiting headache dizzy heart palpitations body aches, Tuesday continued headache body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,SEN,None,None,None,,None,"['Asthenia', 'Chills', 'Dizziness', 'Headache', 'Nausea', 'Pain', 'Palpitations', 'Vomiting']",1,PFIZER\BIONTECH,SYR 920300,WI,36.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 920301,MN,40.0,F,"Patient experienced aching, fever, diarrhea that started 12/30/20. Symptoms continued adding chills , body aches, and vomiting over the next several days leading to an Emergency Room visit on 1/4/20.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,PVT,,,"Hypothyroidism, Ankylosing Spondylitis, Irritable Bowel Syndrome, Iron deficient anemia",,"Bactroban, Codeine, Genteal, Trazadone, Penicillin","['Chills', 'Pain', 'SARS-CoV-2 test negative', 'Urine analysis', 'Vomiting']",1,PFIZER\BIONTECH,IM 920302,PA,42.0,M,"Red rash at injection site (left shoulder) and red rash on left, middle and right neck 9 hours after administration, also weakness, flushed, hot and cold chills without fever 26 hours later. Red rash disappeared within 1.5 hours after taking ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,Ibuprofen,none,none,,none,"['Asthenia', 'Chills', 'Feeling of body temperature change', 'Flushing', 'Injection site rash', 'Rash', 'Rash erythematous']",1,PFIZER\BIONTECH,IM 920303,OH,35.0,F,Itchy rash formed at injection site 8 days after receiving the injection along with fatigue and overall not feeling well,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/01/2021,8.0,PVT,"Zpack started on 12/30/20, prenatal vitamins","Sinus pressure, congestion",,,"PCN, Sulfa","['Fatigue', 'Injection site rash', 'Malaise', 'Rash pruritic']",UNK,MODERNA,IM 920304,MA,45.0,M,"Severe, debilitating chills, mild fever (100.0). Started just after midnight of 12/29/2020. Took 800mg Motrin at approximately 12:45am. Severe chills continued until approximately 02:30am, at which time they resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,WRK,Lisinopril 10mg Omeprazole 20mg Fish Oil 2000mg,COVID positive 12/15/2020,Hypertension- controlled with medication GERD- controlled with medication,,None,"['Chills', 'Pyrexia']",1,MODERNA,IM 920305,WI,37.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,"macrolides and ketolides, sulfa antibiotics","['No adverse event', 'Product storage error']",1,MODERNA,IM 920306,NY,24.0,F,"fever that lasts overnight after vaccination, pain in the left hand where the vaccine was administered, dizziness and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,-,-,-,,-,"['Dizziness', 'Headache', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 920307,OH,45.0,M,"I had an episode of chills in the middle of the night (4:17 am), and I had a 100.9F fever at 6:20 a.m. on 1-5-2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,"Metformin, Jardiance, flowmax , psilium hush","COVID-19 on Dec 6th, 2020","Diabetes, obesity",,,"['Chills', 'Pyrexia']",1,MODERNA,IM 920308,WI,65.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['Incorrect dose administered', 'No adverse event']",1,MODERNA,IM 920309,MN,53.0,F,face swelling several days after receiving the vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,PUB,Clozepam and citopril,sore throat before the vaccination,"anxiety, depression",,"codeine, monistat",['Swelling face'],1,MODERNA,IM 920310,NJ,54.0,F,"woke up at 3 am 1/3/21 with flu like symptoms: chills, fever, body aches, weakness and headache which lasted all day. woke up 1/4/21 feeling better but had headache and was very weak. 1/5/21 still very weak but headache gone",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PVT,none,"diabetes type 2, depression","diabetes type 2, depression",,none,"['Asthenia', 'Chills', 'Headache', 'Influenza like illness', 'Pain', 'Pyrexia']",1,MODERNA,IM 920311,VT,31.0,F,"moderate redness, itching and mild swelling about 3 inches in diameter around left deltoid that appeared 8 days after vaccine injection. Took Tylenol and left alone. Gradually improved and slowly resolved over next few days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,PVT,iron supplement 65mg,none,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 920312,CO,60.0,F,rash at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PVT,"blood pressure, insulin, statin",,"high blood pressure, type 1 diabetes",,sulfa,['Injection site rash'],1,MODERNA,IM 920313,WI,50.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects noted,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 920314,NY,40.0,F,"After an hour of receiving my vaccine, I started feeling a little jittery, my heart rate went up to 113. I felt very short of breath. worst when walking and talking that improved with me sitting. Nausea with lots of drool. Around 4:30 I started feeling body aches . Then at 5 on my way home, i started feeling extreme pain in my joints, to where i couldnt hold the steering wheel tight. Around 7:30 I started having shaking and aching. Around 9:30 I ate potatoes, and took motrin and it helped a little. I felt weak and washed out like I ran a marathon. I was still feeling fatigue and wiped out, I had no energy. I took my pulse ox and it was 95-96. I am now having muscle pain at the injection site, and injection site is very sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Zyrtec 1 pill daily.,Auto immune disease.- trap syndrome,Trap Syndrome and Mild Asthma,,No,"['Arthralgia', 'Asthenia', 'Drooling', 'Dyspnoea', 'Fatigue', 'Feeling jittery', 'Impaired driving ability', 'Injection site pain', 'Nausea', 'Pain', 'Tremor']",UNK,MODERNA, 920315,CT,39.0,F,"0.5 ml Moderna covid vaccine administered in right deltoid at 0630. Several minutes following vaccine c/o feeling flushed and ""really hot."" She was hypertensive and tachycardic throughout the monitoring period following vaccine. She c/o headache, nausea, hot and cold, flushed, noted blotchy skin and shaking hands (noted prior to vaccine) Evaluated by Dr. Husband called to transport home. Instructed when to return to ED",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,none,,,augmentin,"['Feeling hot', 'Feeling of body temperature change', 'Flushing', 'Headache', 'Hypertension', 'Nausea', 'Rash macular', 'Tachycardia', 'Tremor']",1,MODERNA,IM 920316,MA,45.0,M,Recipient reported chest tightness on one side then the other. Blood pressure was checked- 162/103. The recipient was escorted to our facility's outpatient clinic. He reports receiving medication for the blood pressure and being monitor for a few hours but his blood pressure did not decrease. He was encouraged to visit his PCP.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,WRK,,,,,,"['Blood pressure increased', 'Chest discomfort']",1,MODERNA,IM 920317,NY,57.0,F,"Rhonchi, frothy sputum, low grade temp, elevated HR, 12/30 MD assessed 1:00PM and increased prednisone and added Cefdinir. Sent to hospital 12/30 at approximately 6:30PM with worsening symptoms",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,12/29/2020,12/30/2020,1.0,SEN,"buspirone, prednisone, Vit D3, Vit B1, Multivitamin, Ensure Plus, Fentanyl Patch, Levothyroxine, Metoprolol, Ipratropium-Albuterol SVN","Sepsis, Pneumonia, UTI, Respiratory Failure, COPD","CA lymph nodes, liver, brain lung and base of tongue, COPD, CKD, anemia, DM Type 2, Vit D3 Deficiency",,"Bactrim DS, bupropion (bulk), fluoxetine, piperacillan-tazobactam, remeron, latez","['Heart rate increased', 'Pyrexia', 'Rhonchi', 'Sputum abnormal']",1,PFIZER\BIONTECH,IM 920318,CO,61.0,F,"VACCINE SAT AT 1:30 PM, SUNDAY 9:00 AM FEELING TIRED NAUSEATED, TEMP UP TO101 THROUGH THE DAY, HEADACHE,PAIN IN LEFT ARM AT INJECTION SITE. TEMP SEEMED TO BREAK THAT EVENING 98.0 . MONDAY INJECTION SITE VERY RED AND RAISED, ITCHY, ABOUT 1 TO 1 1/2 INCHES IN SIZE. TODAY TUESDAY SAME SIZE ITCHY NOT RAISED .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,PVT,"CRESTOR,COQ10,FISH OIL,ZINC,MAG,VITEM D, VITAMEN C, LICORICE ROOT,HEMP LINIMENTS AND OILS.",NONE,"HAVE POSITIVE COVID ANTIBODIES, WAS VERY ILL WITH UPPER RESPIRATORY VIRUS IN JAN FEB OF 2020. NO TESTING FOR COVID AT THE TIME.",,"CODIENE, MACROBID","['Body temperature increased', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Nausea']",UNK,PFIZER\BIONTECH,IM 920319,WI,53.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effected reported,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,Tetanus-diphth-acell Pertussis No other info available,Tetanus-diphth-acell Pertussis,['Product storage error'],1,MODERNA,IM 920320,FL,33.0,F,Painful axilar Lymphadenopathy same side of injection arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,PVT,Multivitamin,Miscarriage,None,,None,"['Axillary pain', 'Lymphadenopathy']",1,MODERNA,IM 920321,OH,46.0,F,"chills, slight fever, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Lexapro, Vit D 3, Vit A, Claritin, Singulair",Covid 19,,,"Benadryl, Atarax","['Chills', 'Pain', 'Pyrexia']",1,MODERNA,IM 920323,NE,63.0,M,Developed left sided Bell's Palsy two days after receiving COVID vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,OTH,"metformin, simvastatin, lisinopril, glipizide",none,"DM2, HTN, hyperlipidemia, glaucoma",,none,"['Computerised tomogram head', 'Facial paralysis', 'Laboratory test']",1,MODERNA,IM 920324,SC,35.0,F,"Patient reported burning at the injection site shortly after receiving vaccine. She had a burning / swelling sensation of her tongue and otherwise felt unwell. She was placed on a cardiac monitor which showed ST with a VR 142-155, no ectopy. She reports that her HR is usually 130 or less. She had a BP that ranged between 149-160/96-105. She reports this is elevated for her. Patient sent to ED and given Benadryl and prednisone for 3 days. On 1/4, patient contacted MD and stated injection site is red and raised. Continues to take Benadryl and prednisone and has a numb and swollen tongue.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,PVT,,,,,,"['Blood pressure increased', 'Cardiac monitoring', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Malaise', 'Swollen tongue', 'Tongue discomfort']",1,PFIZER\BIONTECH,IM 920325,WI,41.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect reported.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,erythromycin,['Product storage error'],1,MODERNA,IM 920326,IN,89.0,F,Redness and warmth with edema to right side of neck and under chin. Resident was on Hospice services and expired on 1.1.21,Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,SEN,"Cetirizine, Lactaid","G30.1 Alzheimer's disease with late onset (Primary) M19.90 Unspecified osteoarthritis, unspecified site J44.9 Chronic obstructive pulmonary disease, unspecified I95.1 Orthostatic hypotension J45.909 Unspecified asthma, uncomplicated R13.12 Dysphagia, oropharyngeal phase M15.0 Primary generalized (osteo)arthritis M85.80 Other specified disorders of bone density and structure, unspecified site Note: Osteopenia J30.9 Allergic rhinitis, unspecified F41.1 Generalized anxiety disorder M24.511 Contracture, right shoulder M24.512 Contracture, left shoulder M24.521 Contracture, right elbow R29.3 Abnormal posture M17.4 Other bilateral secondary osteoarthritis of knee M25.561 Pain in right knee R26.89 Other abnormalities of gait and mobility Z74.1 Need for assistance with personal care Z91.81 History of falling M62.81 Muscle weakness (generalized) R29.6 Repeated falls R27.8 Other lack of coordination R63.3 Feeding difficulties E73.8 Other lactose intolerance R53.1 Weakness I95.89 Other hypotension","G30.1 Alzheimer's disease with late onset (Primary) M19.90 Unspecified osteoarthritis, unspecified site J44.9 Chronic obstructive pulmonary disease, unspecified I95.1 Orthostatic hypotension J45.909 Unspecified asthma, uncomplicated R13.12 Dysphagia, oropharyngeal phase M15.0 Primary generalized (osteo)arthritis M85.80 Other specified disorders of bone density and structure, unspecified site Note: Osteopenia J30.9 Allergic rhinitis, unspecified F41.1 Generalized anxiety disorder M24.511 Contracture, right shoulder M24.512 Contracture, left shoulder M24.521 Contracture, right elbow R29.3 Abnormal posture M17.4 Other bilateral secondary osteoarthritis of knee M25.561 Pain in right knee R26.89 Other abnormalities of gait and mobility Z74.1 Need for assistance with personal care Z91.81 History of falling M62.81 Muscle weakness (generalized) R29.6 Repeated falls R27.8 Other lack of coordination R63.3 Feeding difficulties E73.8 Other lactose intolerance R53.1 Weakness I95.89 Other hypotension",,Lactose,"['Death', 'Erythema', 'Hospice care', 'Localised oedema', 'Skin warm']",1,MODERNA,IM 920327,NC,56.0,F,"12/30/2020 am started with local reaction of swelling and pain in right arm along with heaviness of right arm. Also extreme fatigue. All of these sx subsided 01/02/2021. 12/30/2020 pm started with chills, assumed fever, achiness of arms and legs, nightmares, waking up in the middle of the night right sided headache. All of these sx have subsided (12/31/2020) except for headache and waking up at night. These two sx continue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PUB,None,None,"High blood pressure, arthritis",,None,"['Chills', 'Fatigue', 'Headache', 'Limb discomfort', 'Local reaction', 'Nightmare', 'Pain in extremity', 'Peripheral swelling', 'Sleep disorder']",1,MODERNA,IM 920328,NY,56.0,F,Patient complained of metallic taste in mouth and tingling in top lip immediately after the vaccine. Resolved after 5 minutes.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,Dupixent,,"PVD left eye, ERM left eye, Myopia both eyes, eczema",,Sulfa medications,"['Dysgeusia', 'Immediate post-injection reaction', 'Paraesthesia oral']",1,MODERNA,IM 920329,PA,58.0,F,"A week after receiving the vaccine I noticed a bright red warm 2"" x2"" circle on my arm. (possible cellulitis?) I called my PCP but they wanted me to notify you to see what I should do about it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,"MVI, Vitamin D3, calcium, Vtamin C, Lysine",none,none,,None,"['Erythema', 'Feeling hot']",UNK,MODERNA,IM 920330,,59.0,F,"Patient's reaction(s) noted during COVID vaccine observation period: Redness, swelling, or pain at the injection site, extending >2cm diameter area(states it feels like it's in her bones). Pain worse with movement. No redness/swelling. Actions Taken: VS taken and WNL, with the exception of BP being a little high for her. She was offered the opportunity to go to ED and declined saying that it is manageable and will take Tylenol. � Disposition: Patient declined ED visit",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,,,,,,"['Bone pain', 'Hypertension', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Pain']",1,PFIZER\BIONTECH,IM 920331,WI,25.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect reported,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 920345,TN,66.0,F,"Suspected vaccination failure; 10 weeks after second dose developed a mild case of shingles; received the first dose on 11/8/2019 second dose on 5/27/2020; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 27th May 2020, the patient received the 2nd dose of Shingrix. On 8th November 2019, the patient received the 1st dose of Shingrix. On 27th May 2020, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. In August 2020, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. Additional details were provided as follows: The patient reported for herself. The patient received 1st dose of Shingrix vaccine on 8th November 2019 (for tolerance of 1st dose, refer case US2020254965) and 2nd dose on 27th May 2020, which led to lengthening of vaccination schedule. The patient experienced a mild case of shingles. This case was considered as suspected vaccination failure as details of laboratory confirmation test was unknown at the time of reporting. The reporter did not have lot number or expiration date information to provide. The reporter consented to follow up with HCP.; Sender's Comments: US-GLAXOSMITHKLINE-US2020254965:same reporter, 1st dose",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,11/08/2019,05/27/2020,201.0,PHM,,,,,,"['Herpes zoster', 'Inappropriate schedule of product administration', 'Vaccination failure']",1,GLAXOSMITHKLINE BIOLOGICALS, 920352,SD,35.0,F,"Moderna COVID-19 Vaccine EUA fatigue, nausea, headache, severe arm pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,PVT,"Nortryptilline 50 mg, Pristiq 50 mg, Lexapro 10mg, multivitamin, vitamin D, Depo provera, Relpax 40 mg (as needed), Ketolorac (as needed), emgality injection",,"GAD, moderate episode of major depressive disorder, migraines",,none,"['Fatigue', 'Feeling abnormal', 'Headache', 'Nausea', 'Pain in extremity']",1,MODERNA,IM 920353,KY,43.0,F,"1 week after receiving vaccine, developed moderate rash, reddened, swollen, itchy and hot to touch at injection site on 1/4/2021. The delayed reaction is my concern.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PUB,none,none,none,,Phenergan,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 920354,TN,30.0,F,Fever with chills,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,WRK,Vitamin D and Zinc,None,Covid positive in Fall,,None,"['Chills', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 920356,NJ,29.0,F,"Diarrhea starting 2 hours after injection Then headache a few hours later That night fevers to 101.4, chills, aches, fatigue, weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Levothyroxine,Tested positive for Covid on 11/27/2020,Hypothyroid,,Minocyclene,"['Asthenia', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,SYR 920357,KY,43.0,F,"1 week after receiving vaccine, developed itchy rash, swollen, hot to touch, and redness at injection site on 1/4/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PUB,none,none,none,,Phenergan,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Rash pruritic']",1,MODERNA,IM 920358,WI,33.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects reported,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,pollen extract,"['No adverse event', 'Product storage error']",1,MODERNA,IM 920359,MD,60.0,F,"Temp up to at least 104, SEVERE Muscle Aches, Nausea, Vomiting, Headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,"Cymbalta, Trazodone, Meloxicam, Airbourne",na,HTN,,"NA, but vegetarian","['Body temperature increased', 'Headache', 'Influenza virus test', 'Myalgia', 'Nausea', 'SARS-CoV-2 test', 'Vomiting']",1,MODERNA,IM 920360,MS,45.0,F,Moderna Covid19 vaccine EUA. On January the 4th at 9:45 patient received the vaccine around in 11:45am o'clock I started having lower back symptoms. I injured my scartic nerve one year in a 1/2 ago from lifting and for some particular reason that nerve started to hurt hours after vaccine. Today is 01/05/2021 and my scartic nerve is still aching as of today. Nerve started aching and hurting after Moderna Covid19 vaccine. I was having any problems with nerve before vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,No,No,Not to my knowledge,,No,"['Back pain', 'Condition aggravated', 'Neuralgia', 'Sciatica']",1,MODERNA,SYR 920361,AL,48.0,F,"Moderna COVID-19 Vaccine EUA Fever, chills, body aches, shortness of breath, increased anxiety with palpitations and dizziness, soreness at site of injection. Symptoms started at approximately 11 p.m. the night of the injection (Wednesday) and lasted throughout the next day (Thursday). I took some Zyrtec on Thursday at approximately 8 p.m., slept great, and felt back to normal on Friday.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Prozac 40 mg, turmeric with circumen, fish oil",Covid-19 approximately 2 weeks prior to vaccination,"Hypertension, anxiety/depression",,Latex allergy,"['Anxiety', 'Chills', 'Dizziness', 'Dyspnoea', 'Injection site pain', 'Pain', 'Palpitations', 'Pyrexia']",UNK,MODERNA,IM 920362,,37.0,F,"5inx6in redness, itching and warmth around vaccine IM site of left deltoid. Patient reported these symptoms to me today. Vaccine provided by her employer. Provided Cephalexin antibiotic for suspected cellulitis.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/25/2020,2.0,PVT,,,,,,"['Cellulitis', 'Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 920363,SC,41.0,F,"Received vaccine on 12/23/20 at approximately 7:35pm. By 10 pm the right arm started to swell at the injection site and became itchy burning and red. A knot the size of a gumball appeared. By the next morning it was the size of a softball.. It continued to spread to a rectangular shape a little bigger than a softball approximately 4"" in height and 8"" in width. Arm was sore and itching. I tried my best to keep from scratching at the site and took my claritin and ibuprofen and made sure to wear a long sleeve shirt to keep me from scratching at it. I figured I was making it worse because I tend to sleep on my right side as well. By Sunday night it went away.. Then Tuesday night the 29th of December arm started getting itchy and burning again. By Thursday the 31st my arm was back to the size of softball again and arm itchy and red. Let a few physicians hear in the emergency room where I work look at it and their only suggestion was to use a topical Benadryl. I never officially took my temperature but their was definite heat coming from the site. Not a single physician could explain why it went away and then came back. The knot didn't grown any bigger and with the topical benadryl I have managed to keep the itching away. The swelling started going back down again on Sunday 01/03/21 but there is still a knot the size of a grape now and the area is still red. Some days it is itches more than others.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,claritin 10mg daily and ibuprofen occasionally,sinus infection that lasted about two weeks with cough and runny nose the week of holiday. Tested for covid and it was negative. symptoms of infection cleared on their own after taking sudafed,mild hypertension,,none,"['Injection site erythema', 'Injection site nodule', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity', 'Pruritus']",1,MODERNA,IM 920364,PA,42.0,F,Patient completed the 15 minute Observation period without incident and left the clinic. She returned 1 hour later complaining of an itchy on Left Forearm just below the elbow . Nothing noted at injection site. No other complaints. Also had reddened itchy are in same place on right arm. Given 25mg of liquid po Benadryl. Observed by onsite paramedic for 45 minutes. Redness and itching areas resolved. Left clinic and returned to work.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,,,,,,"['Erythema', 'Pruritus']",1,MODERNA,IM 920365,WI,61.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse reaction reported,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,ibuprofen,"['No adverse event', 'Product storage error']",1,MODERNA,IM 920366,NC,25.0,F,"Patient's reaction(s) noted during COVID vaccine observation period: dizziness �Actions Taken: VS taken x2, both sets WNL. Pt decided she felt good enough to go home. �Disposition: Patient declined ED visit",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 920368,IN,92.0,F,"12/30/2020 07:02 AM Resident noted to have some redness in face and respiration were fast. Resident vital signs were abnormal except blood pressure. Temp at the time was 102.0 F taken temporal. Resident respirations were 22 labored at times. Pulse is 105 and pulse ox 94% on room air. Resident is made comfortable in bed. Notified triage of change in condition also made triage aware of resident receiving Covid vaccination yesterday morning. Resident appetite and fluid consumption has been poor for few days. 12/30/2020 07:32 AM Received order from agency to administer Acetaminophen 650mg suppos rectally due to resident not wanting to swallow anything including fluids, medications and food. This writer administered medication as NP ordered. Will monitor for effectiveness and adverse effects if any. 12/30/2020 08:41 AM Received new orders to obtain Flu swab, obtain CBC and BMP, and Chest Xray all to be obtained today. Notified family of resident having temperature and vital signs excluding b/p that was abnormal. Family was thankful for call and inierated to nurse that family does not want resident sent to hospital. Did educate family on benefits of Hospice services, but family persistant on continued daily care provided by nursing staff. Requests visits if decline continues. Family assured if resident continues to decline, facility will accomandate resident family to be able to be at bedside when time comes to do so. NP ordered IVF and IV Levaquin on 12/31/20. Family chose at that time to sign for Hospice services and not have resident provided with IVF or IV Antibiotics",Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,SEN,"Acetaminophen, Atenolol, Colace, Lisinopril, Mirtazapine, Omeprazole, Simvastatin, Vitamin D3","F03.90 Unspecified dementia without behavioral disturbance E78.5 Hyperlipidemia, unspecified K21.9 Gastro-esophageal reflux disease without esophagitis I10 Essential (primary) hypertension Z74.09 Other reduced mobility M62.81 Muscle weakness (generalized) R13.12 Dysphagia, oropharyngeal phase R26.81 Unsteadiness on feet R27.8 Other lack of coordination R41.841 Cognitive communication deficit R54 Age-related physical debility D53.9 Nutritional anemia, unspecified R29.6 Repeated falls M13.80 Other specified arthritis, unspecified site M25.512 Pain in left shoulder M19.012 Primary osteoarthritis, left shoulder K59.09 Other constipation R26.89 Other abnormalities of gait and mobility R63.8 Other symptoms and signs concerning food and fluid intake M85.89 Other specified disorders of bone density and structure, multiple sites Note: Osteopenia M24.512 Contracture, left shoulder J43.9 Emphysema, unspecified","U07.1 2019-nCoV acute respiratory disease (Primary) F03.90 Unspecified dementia without behavioral disturbance E78.5 Hyperlipidemia, unspecified K21.9 Gastro-esophageal reflux disease without esophagitis I10 Essential (primary) hypertension Z74.09 Other reduced mobility M62.81 Muscle weakness (generalized) R13.12 Dysphagia, oropharyngeal phase R26.81 Unsteadiness on feet R27.8 Other lack of coordination R41.841 Cognitive communication deficit R54 Age-related physical debility D53.9 Nutritional anemia, unspecified R29.6 Repeated falls M13.80 Other specified arthritis, unspecified site M25.512 Pain in left shoulder M19.012 Primary osteoarthritis, left shoulder K59.09 Other constipation R26.89 Other abnormalities of gait and mobility R63.8 Other symptoms and signs concerning food and fluid intake M85.89 Other specified disorders of bone density and structure, multiple sites Note: Osteopenia M24.512 Contracture, left shoulder J43.9 Emphysema, unspecified",,quinine sulfate,"['Blood creatinine increased', 'Blood urea increased', 'Body temperature increased', 'Chest X-ray abnormal', 'Decreased appetite', 'Dyspnoea', 'Erythema', 'Full blood count', 'Hospice care', 'Influenza virus test negative', 'Lung infiltration', 'Metabolic function test', 'Respiratory rate increased', 'Vital functions abnormal', 'White blood cell count increased']",1,MODERNA,IM 920369,NJ,47.0,F,"Fever, chills, myalgia, sweats",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,Trikafta Concerta,None,Cystic fibrosis,,Sulfa,"['Chills', 'Hyperhidrosis', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 920370,IL,28.0,F,"Red hive like rash and felt hot. She was also feeling dizzy Epinephrine given IM After 5 minutes, her symptoms returned and another Epinephrine given IM",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,Unknown,Grave's Disease/Hyperthyroidism,None,,distant (at age two) amoxicillin,"['Dizziness', 'Feeling hot', 'Rash erythematous']",1,PFIZER\BIONTECH,IM 920371,CT,26.0,F,"Significant soreness, pain lifting arm, tenderness to any touch, redness around 1 in in diameter around injection site for 7 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,"Humalog insulin, Tresiba insulin, bupropion, levothyroxine, tri-lo marzia",None,"Type 1 diabetes, hashimoto's thyroiditis, vitiligo",,None,"['Injection site erythema', 'Pain', 'Tenderness']",1,MODERNA,IM 920372,VA,37.0,F,"initially arm was sore for several days. Then 1 week later progressed to swollen area about 2"" in diameter that felt like a knot under the skin. The area was warm to touch, white or non-pigmented, and surrounded by hives. After 24 hours and several doses of amoxicillin, the area is improving but continues to be warm, surrounded by hives with pigmentation returning. The knot does not feel as tight.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,PVT,,,,,Cephalexin,"['Nodule', 'Pain in extremity', 'Peripheral swelling', 'Skin discolouration', 'Skin warm', 'Ultrasound scan normal', 'Urticaria']",1,MODERNA,IM 920373,ME,35.0,F,"Immediately following vaccine I experienced expected muscle soreness in affected arm. Symptoms resolved by 12/31 (day 3). On 01/02/21 in the evening I began to experience tenderness in my underarm arm of my left arm. about 24 hours later 01/03/21in the evening I continued to experience pain which began spreading to front and back shoulder. Pain extended down my left arm when reaching/extending arm. Upon rising 01/04/21 swelling in underarm included lump approximately size of mandarin, swolling noted in left bicep. Aching in arm, pain continued to extend down arm. Other symptoms included malaise, sore throat, nasal congestion, mild headache. reported to employee health line, asked to receive COIVD test, informed to follow up with PCP regarding arm symptoms as ""after 72 hours this is not considered side effects from the vaccine"". PCP referred to respiratory clinic to f/u to monitor swelling/pain. Provider ordered ultrasound for underarm lump/swelling thought to be in response to COVID vaccine also to view veins in left arm due to my history of DVT. currently awaiting ultrasound appointment for additional information.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,WRK,flonase,not identified,History of DVT in 2002; history of latent TB; prothrombin gene mutation present,,NKFDA,"['Headache', 'Injection site mass', 'Injection site pain', 'Injection site swelling', 'Malaise', 'Nasal congestion', 'Oropharyngeal pain', 'Pain in extremity']",UNK,MODERNA, 920374,PR,47.0,F,DIZZINESS,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,,,PRE DIABETES,,PROTONIX,['Dizziness'],2,PFIZER\BIONTECH,IM 920375,NY,56.0,F,"Headache ,chills upset stomach ,muscle fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Synthroid , Allegra ,multivitamin",None,None,Flu vaccine,Dairy,"['Abdominal discomfort', 'Chills', 'Headache', 'Muscle fatigue']",1,MODERNA,SYR 920377,WI,57.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects reported.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,"celecoxib, NSAIDs, prednisone, zoledronic acid","['No adverse event', 'Product storage error']",1,MODERNA,IM 920378,IL,40.0,F,"About 30 minutes after the vaccine, I was driving and suddenly felt congestion, flushing and a sense of fullness/swelling in my throat. I pulled over and called my husband. I could breathe fine, but the sensation of swelling in my throat was frightening and I felt like I couldnt swallow my saliva. I also had the feeling like I might faint (hot and flushed). This all passed pretty quickly (5 minutes), and I took a benadryl when I got home and rested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,Zoloft 50mg Daily,None,none,,"No drug allergies. Allergic to shellfish (crab), and Mango","['Dizziness', 'Dysphagia', 'Feeling hot', 'Flushing', 'Pharyngeal swelling', 'Respiratory tract congestion']",1,PFIZER\BIONTECH,IM 920379,NC,44.0,F,"Patient's reaction(s) noted during COVID vaccine observation period: headache, actions Taken: VS taken x2 and stable both times. Pt felt okay enough to go home. �Disposition: Patient declined ED visit",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,WRK,,,,,,['Headache'],1,PFIZER\BIONTECH,IM 920380,,54.0,F,"Headache on day 1 about 1 hour after vaccine administration, on 12/25 developed a swollen lymph node under her arm pit, on 1/1 she developed swollen lymph nodes in her neck.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,WRK,,,,,,"['Headache', 'Lymphadenopathy']",1,MODERNA,IM 920381,PR,25.0,F,"HEADACHE, SWEILLING ON LEFT AXILLA AND DECREASE IN ENERGY. VISITED EMERGENCY ROOM, NO TREATMENT, PATIENT WAS ORIENTED TO MONITOR GANGLIAL SWELLING AND TO REPORT TO ER IF SIGNIFICANT CHANGES WERE NOTED LIKE INCREASE IN SIZE, INCREASE IN PAIN OR REDNESS.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,none,none,none,,none,"['Asthenia', 'Headache', 'Oedema peripheral']",2,PFIZER\BIONTECH,IM 920382,IN,28.0,F,Fainted at 6:30 a.m. the next morning,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,None,None,None,,None,['Syncope'],1,MODERNA,SYR 920383,FL,43.0,F,Red elevated rash 5-6 cm diameter on injection site with slight pruritis . Appeared on day 8 post vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/05/2021,8.0,UNK,"Multivitamins, omega-3",,Hypothyroidism,,NKDA,"['Injection site pruritus', 'Injection site rash', 'Rash erythematous', 'Rash papular']",1,MODERNA,IM 920384,FL,69.0,F,"Numbness from Neck to face to head on the left side. Lasted a few days. 12-30-2020 to January 3rd, 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Natures Bounty-Hair, Skin and Nails",none,none,,none,['Hypoaesthesia'],1,PFIZER\BIONTECH,IM 920385,IL,30.0,F,"12 hours after injection I began to have chills and rigors, the rigors subsided after ~30 min. For the next 11 hours i had chills, severe body aches, a headache and spiked a fever to 101. The following day after ~12 hrs of symptoms I began to improve slightly and all that remained was a severe headache and body aches. Now, I am about 32 hours in to the adverse event and I still have a headache and sore arm/shoulders but other symptoms have resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,WRK,None,None,None,,None,"['Adverse event', 'Arthralgia', 'Chills', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 920388,FL,57.0,F,"Patient received her Vaccine on 12/16/2020. Afterwards she developed symptoms of fever, chills, diarrhea, nausea, vomiting and headache that became worse over time and on day os presentation to our hospital on 1/2/2021 she was having photophobia. Current headache at time of admission had been persistent for over a week. Patient has no immunocompromising risk factors and was diagnosed with confirmed CMV meningitis. She was also admitted with transaminitis.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/16/2020,12/16/2020,0.0,UNK,unknown,unknown,craniotomy in 1998 due to meningioma,,codeine,"['Chills', 'Diarrhoea', 'Headache', 'Meningitis viral', 'Nausea', 'Photophobia', 'Pyrexia', 'Transaminases increased', 'Vomiting']",UNK,PFIZER\BIONTECH, 920390,NC,60.0,F,"SWELLING OF HANDS AND FACE, LASTED FOR ABOUT 2 HOURS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Tylenol,no,kidney failure,,no,"['Peripheral swelling', 'Swelling face']",1,PFIZER\BIONTECH,IM 920391,NY,53.0,F,"3:30 nausea, dizziness, soreness and swelling at site of injection 4:30PM headache 6:30 PM chills and body aches 08:00PM itching - no rash, numbness in l shoulder, neck face-cheek, jaw , lip; 10:00PM still able to move muscles no signs of bell's palsy. Ibuprofen dose, relief of chills and body aches. Symptoms have resolved but l jaw still experiencing numbness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,,,"Hypothyroid, Sarcoidosis",,,"['Chills', 'Dizziness', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Injection site hypoaesthesia', 'Injection site pain', 'Injection site swelling', 'Nausea', 'Pain', 'Pruritus']",1,MODERNA,IM 920392,FL,49.0,M,Lump developed on forearm opposite side of injection site with intermittent sharp pain beginning 1/4/21 at approximately 10pm lasting 2 seconds like a sting.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,Terazosin 1mg Nifedipine 60mg Simvastatin 20mg Losartan 50mg Glipizide 5mg Vitamin D 400 units Setraline 50mg,None,Hypertension.,,Penicillin,['Nodule'],1,MODERNA,IM 920393,WI,39.0,U,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects reported.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 920394,NC,41.0,M,Patient's reaction(s) noted during COVID vaccine observation period: lips tingling like when he eats shellfish; has shellfish allergy �Actions Taken: Vital signs taken and within normal. Pt felt okay enough to go home. �Disposition: Patient declined ED visit,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,,,,,,['Paraesthesia oral'],1,PFIZER\BIONTECH,IM 920395,MI,34.0,F,"Felt hot/flushed almost immediately after vaccine. Continued to have hot flashes (afebrile) relieved by Tylenol through the following Tuesday (5 days after vaccine). Hot flashes are intermittent. Also feel fatigued starting Saturday 1/2, improved 1/3, worsening 1/4 into 1/5. Sore arm for about couple days, very mild.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Pepcid, probiotic, oral birth control, Singulair, Flovent, Allegra",none,"PCOS, Asthma",,seasonal allergies,"['Fatigue', 'Feeling hot', 'Flushing', 'Hot flush', 'Immediate post-injection reaction', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 920396,PA,32.0,F,"Had fever for 36 hours accompanied by muscle aches, nausea, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,none,Covid positive on 12/16/2020,none,,none,"['Fatigue', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,IM 920397,WI,44.0,F,"Day 1: (12/23/20) fatigue, mild headache Day 2: (12/24/20) fatigue mild headache Day 3-5 (12/25/20-12/29/20)- large painful lymph node inflammation approx. size of a baseball. Right axilla.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/25/2020,2.0,PVT,"Lamictal, bupropion",None,None,,none,"['Fatigue', 'Headache', 'Injection site inflammation', 'Lymph node pain']",2,PFIZER\BIONTECH,IM 920398,,50.0,F,left sided numbness,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/23/2020,2.0,WRK,,,,,,['Hypoaesthesia'],1,PFIZER\BIONTECH,IM 920400,WI,62.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects reported.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 920401,IA,24.0,F,Woke up at about 3:30am feeling warm. Checked my temperature and it was 101.4. Also experienced joint aches and a headache.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,estarylla,None,None,,None,"['Arthralgia', 'Body temperature increased', 'Feeling hot', 'Headache', 'Sleep disorder']",1,PFIZER\BIONTECH,SYR 920402,MD,43.0,F,"At day 6, developed a hive (about 7-8cm in diameter) at the vaccine site with some itching, redness, warmth. No systemic symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,WRK,Enbrel Plaquenil ASA MVI Prilosec,None,Rheumatoid arthritis,,IV Iron,"['Injection site erythema', 'Injection site pruritus', 'Injection site urticaria', 'Injection site warmth']",1,MODERNA,IM 920404,IL,60.0,M,"Chills, Body malaise, and sore at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,,,Asthma,,,"['Chills', 'Injection site pain', 'Malaise']",1,MODERNA,IM 920405,WI,33.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects reported.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,prochlorperazine,"['No adverse event', 'Product storage error']",1,MODERNA,IM 920406,NY,36.0,F,Headache with fogginess that turns into nausea. Flushed feeling in face. L breast is more full and sore. Headaches come and go and feel like a vice on the top and side of my head that then lets go. Intensifies in afternoon typically or first thing in morning.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,WRK,None,None,None,,None,"['Breast pain', 'Feeling abnormal', 'Flushing', 'Headache']",1,MODERNA,IM 920407,PA,26.0,F,Started getting mild headaches on 1/1/2021 which comes around noon and goes away in evening after 6-7 pm. Still getting headaches everyday since 1/1/2021 in same pattern and at same time. Also feeling little nauseous over past few days.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,WRK,N/a,N/a,N/a,,N/a,"['Headache', 'Nausea']",1,MODERNA,IM 920408,WI,33.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect reported,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,prochlorperazine,"['No adverse event', 'Product storage error']",1,MODERNA,IM 920409,GA,28.0,F,"Fever 103.9, chills, vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/21/2020,20.0,PVT,Beyaz birth control,,,,,"['Chills', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 920410,NY,43.0,M,"severe injection site pain, starting day of injection and lasting 48 hours severe headache and neckache, staring evening of injection and lasting 72 hours, intermittent night sweats, approximately 60 hours after injection starting the evening after injection, pain increased in injection site. In middle of night, woken up by severe headache pain. Treated with 600mg ibuprophen and 2.5 mg Zomig. Throughout next day, injection site and headache pain present, but less worse than night, treated with ibuprofen. Second evening (approx 36 hours after injection), pain again severe in the middle of the night, woke up, treated with 600 mg ibuprofen and 2.5 mg Zomig. Woke up sweating, but feeling better. Symptoms gradually resolved over the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Vitamin C, 1000 mg, once daily Vitamin D3, 1000u, once every other day Quercetin, 500mg, twice weekly, Mon, Thurs Melatonin, 0.5mg, once daily in evening Zomig, 2.5mg, PRN migraine pain; typically take 2-6 times annually",none,obesity migraines,,no known allergies,"['Headache', 'Hyperhidrosis', 'Injection site pain', 'Neck pain']",1,MODERNA,IM 920411,VA,37.0,F,Eye Twitching,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,,,,,,['Blepharospasm'],UNK,PFIZER\BIONTECH,IM 920412,NY,61.0,M,"High Fever, Chills, Weakness, Pains (joint & Muscle), Cough, Note; this was worse then when I originally had COVID in April 2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,PVT,"Synthroid, Metoprolol, Livalo, Aspirin (81mg), Omeprazole, Co Q10 (200mg) 800 I.U. Vitamin e,",None,Hart Disease,,None,"['Arthralgia', 'Asthenia', 'Chills', 'Cough', 'Myalgia', 'Pyrexia']",2,MODERNA,SYR 920413,WI,36.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects reported.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 920414,OH,64.0,F,"Light red patch on arm about 3 inches in diameter, first noticed on Sunday, January 2 after swimming. It doesn't hurt and isn't hot or swollen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/03/2021,10.0,WRK,"Lexapro 10 mg, caltrate, vit D, Tumeric, vit E",none,none,,none,['Erythema'],1,MODERNA,IM 920415,MA,41.0,F,"Recipient reported chest tightness, throat closing up, tachycardia, feeling flush approximately 2 minutes after vaccine administration. B/P- 162/76, HR- 124, O2 sat. 100%. She was taken to our outpatient clinic for close monitoring. Some symptoms were resolving. She reported right and then left arm numbness with a heavy feeling in her left eye. She remained in the outpatient department for monitoring until approximately 3p last set of vital signs B/P- 109/72, HR- 16, O2 sat. 100%",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,WRK,,,,,,"['Asthenopia', 'Chest discomfort', 'Flushing', 'Hypoaesthesia', 'Tachycardia', 'Throat tightness']",1,MODERNA,IM 920416,SD,62.0,F,"chills, fever 101, sore swollen right arm at injection site, achy flu like symptoms, headache starting 12/28/20 in the morning until approximately 4:30 pm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/28/2020,1.0,PVT,"crestor,asa,sertraline,omeprazole",Recovering from Covid November 4 2020,,,nka,"['Chills', 'Headache', 'Influenza like illness', 'Injection site pain', 'Injection site swelling', 'Pyrexia']",1,MODERNA,IM 920417,MA,25.0,M,"I am experiencing Chills, Fatigue, Aches, soreness at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,,,,,,"['Chills', 'Fatigue', 'Injection site pain', 'Pain']",1,MODERNA,IM 920418,WI,27.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects reported.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 920419,IL,51.0,F,"Sore at injection site, headache, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,"Metoprolol Tartate, Vitamin B complex, Zinc, Apple Cider Gummies",,Hypertension,,,"['Dizziness', 'Headache', 'Injection site pain']",1,MODERNA,IM 920420,NC,33.0,F,"Injection received in left upper arm. Injection site was quite low on the arm. Redness, swelling, and warm to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/29/2020,7.0,WRK,None,NOne,Migraines,,NKA,"['Cellulitis', 'Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site warmth', 'Product administered at inappropriate site']",1,PFIZER\BIONTECH,IM 920421,NJ,46.0,F,"fever, body aches, chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,none,I had a runny nose,migraines,,none,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 920424,WI,45.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects reported.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 920426,FL,26.0,M,Big red circle around injection site occuring 6 days after vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PVT,Finasteride 1mg Albuterol PRN,,Asthma,,NKDA,['Injection site urticaria'],1,MODERNA,SYR 920427,OH,57.0,F,"Noticed some itching on my left arm at injection site and there was 3 large sized welts/hives on that area of my arm. They were itching, red, raised and slightly warm. Seen by CNP 1/4/21 Advised to take benedryl. Took some that night . This morning still have the 3 welts and still red but, the itching is not as bad as yesterday.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,01/04/2021,9.0,PVT,"Gabapentin, Tramadol, Atenolo and Hydrochlorathiazide and Vitamin B",None,hypertension,"09/29/20 Flu Vaccine Following day became red, slighty raised at injection site and warm-lasted 2 days GSK Lot N97L7 Exp 6/30/21",None,"['Erythema', 'Injection site pruritus', 'Pruritus', 'Skin warm', 'Swelling', 'Urticaria']",1,MODERNA,IM 920428,TX,47.0,F,"Within 5 minutes of the vaccine given, tingling sensation down both arms, up the trunk to the back of the throat, metal taste in mouth, immediately started coughing, tickle at the back of the throat, pulse elevated at 110. O2 sats remained 95%-98%, monitored by paramedic for 20 minutes, 2 Benadryl (50mg), cough subsided, notified (primary doctor) started on Zyrtec 4x/day, Allegra 180 mg BID, Benadryl prn, continue this regimen for 3 days, ( improvement with cough when taking medication) Heart rate remains 80-90's, higher than baseline, instructed to start steroid dose pack on January 5th, pulse 100's, continued cough.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PUB,"Vitamin C, Vitamin D, Probiotic, Viracid",none,none,,none,"['Cough', 'Dysgeusia', 'Heart rate increased', 'Paraesthesia', 'Pharyngeal paraesthesia', 'Throat irritation']",UNK,MODERNA, 920429,NC,57.0,F,"01/04/2021 pt was feeling light headed and not ""herself""' prior to 09:00PM pt fell and loss consciousness. Pt was aroused by Spouse to awake after fall and checked pt blood pressure 115/63 and sugar levels 93. Pt feeling weakness afterwards, pain in back and neck from fall. Awaiting calls from PCP and Neurologist for appointments.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,PVT,"levothyroxine, Fluoxetine HCL, Amlodipine 5 mg, Saxenda 3 mg, Mulitivitamin, B12",,"Diabetes, Thyroid, Blood Pressure",,"Lisinopril, Darvocet","['Asthenia', 'Back pain', 'Dizziness', 'Fall', 'Feeling abnormal', 'Loss of consciousness', 'Neck pain']",1,PFIZER\BIONTECH,IM 920430,WI,42.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect reported.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 920431,KS,42.0,F,"Patient took ibuprofen, 2 zyrtec, 2 pepcid and ubrelvy that morningat 7am. Injection was administered at 9:30am, reaction started at 09:45am increased phelgm, severe migraine, tightness in chest, tongue swelling face swelling, patient took 4 zyrtec, 4 pepcid, ubrelvy. By 4pm tightness of chest and increased mucus subsides. That evening patient took 2 zyrtec 2 pepcid, 2 benadryl that evening, continued to have severe migraines, face and tongue swelling until 1/5/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Zyrtec, pepcid, ubrelvy, ibuprofen",Flu A 12/17/2020,"Severe allergies to environment, medication, foods",,"Trees, wheat, yeast, corn, dogs, cats, feathers, horses,molds, grass, effexor, sulfa, erythromycin, PCN, nuts, hydroxyzine","['Chest discomfort', 'Migraine', 'Rhinorrhoea', 'Swelling face', 'Swollen tongue']",1,MODERNA,IM 920432,MA,41.0,F,"Recipient reported symptoms of chest tightness, throat closing up, tachycardia and feeling flush approximately 2 minutes after the vaccine administration. She was taken to our outpatient clinic for continued observation. Vital signs: B/P 162/76, HR-124, O2- 100% she had relief of some symptoms but also reported right then left arm numbness and heaviness of the left eye. She was monitored for until approximately 3p. Last set of vital signs: B/P 10/72, HR- 81, O2- 100%.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,WRK,,,,,,"['Asthenopia', 'Chest discomfort', 'Flushing', 'Hypoaesthesia', 'Tachycardia', 'Throat tightness']",1,MODERNA,IM 920433,TN,31.0,F,"Solitary enlarged lymph node in left posterior cervical chain, approximately 2 cm in diameter, nontender. Enlargement initially felt the morning after receiving the vaccine. The lymph node continued to enlarge for several days and has remained 2 cm (visible bulge) at 7 days post-vaccination. No other cervical or axillary lymphadenopathy. Left arm sore for 24 hours post vaccination. No other swelling, redness, systemic or local reactions.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,None,None,None,,None,"['Lymphadenopathy', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 920435,MO,38.0,F,"Pt appears to suffer from a localized reaction that appears to be cellulitis nine days post injection. Per the patient she started having symptoms a few days post injection but did not have the pain, induration and warmth that she had when she made her appointment here at the clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/24/2020,2.0,PVT,,,,,"Wellbutrin, Norco and Percocet","['Injection site induration', 'Injection site pain', 'Injection site warmth', 'Skin reaction']",1,MODERNA,IM 920436,WI,63.0,M,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effect reported.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 920437,MA,23.0,F,"Patient vaccinated at 1727 in COVID vaccine clinic, reported feeling like ""my throat is closing"" at 1739. This RN assessed for airway compromise and took VS (O2 sat: 98%, BP: 122/80 (RUA), RR: 16, HR:75 bpm). Patient observed for 30 min, patient received water and remained seated. No further reports of symptoms/adverse reactions prior to leaving clinic around 1800.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None,None,,,NKA,['Throat tightness'],1,MODERNA,IM 920438,IL,38.0,M,"Sore injection site, Dizziness, Headache, Body malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,"Vit C, Vit E, Vit D3, Antihistamine",None,None,,Ceftriaxone IV,"['Dizziness', 'Headache', 'Injection site pain', 'Malaise']",1,MODERNA,IM 920439,VA,37.0,F,"Fever (up to 101.7), burning on skin throughout body (arms, legs and face), nausea, headache, chills, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,UNK,None,None,None,,"Allergic to all cillins (penicillin, ampicillin, etc) and cyclosporine. Sensitive to sulfa drugs and bactrum,","['Chills', 'Dizziness', 'Headache', 'Nausea', 'Pyrexia', 'Skin burning sensation']",UNK,MODERNA,SYR 920440,KY,31.0,F,"As entered by RN into Medical Record: Patient stated that she felt dizzy when she stood up. Patient's blood pressure elevated to 130's/100's, down at discharge to 126/92. Pulse rate was high at 132 about 10 minutes after injection. Patient stated that she had a cardiac ablation done in 2016 and currently takes propranolol BID. Last dose taken was 0800 with food. Per patients watch HR prior to vaccination was in the 60's. Patient was held for 45 minutes with no change in B/P or pulse rate. Family Provider notified, per PA have patient monitor for a couple of hours at home if able to drive and return to ER if not any better. Provider instructed patient not to take another dose of her beta blocker at this time. Patient was instructed to call clinic with any other issues. V/S at discharge 126/92 pulse 120. Called patient in the evening on 12/29/2020 at 7:30 pm. She stated she did feel better but still had a ""jittery"" feeling and HR was still in the 120's per her watch reading. No SOA reported. Did report some nausea. Patient did not feel in distress. Instructed in symptoms continued to visit the ER. 12/30/2020 at 0848 visited Medical Center for tachycardia and HTN. Prescribed steroids and metoprolol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Xanax, Nortriptyline Hcl, Nexium, Keppra, Topiramate, Propranolol Hcl, Emgality, Abilify, Ondansentron, Rimegepant Sulfate",None known,"Tachycardia, cardiac ablation, acid reflux, migraines",,Dopamine,"['Alanine aminotransferase', 'Aspartate aminotransferase', 'Blood pressure increased', 'Dizziness postural', 'Electrocardiogram', 'Feeling jittery', 'Full blood count', 'Gene mutation identification test', 'Heart rate increased', 'Hypertension', 'Nausea', 'Tachycardia']",2,GLAXOSMITHKLINE BIOLOGICALS,IM 920441,NY,47.0,F,"Pruritus, redness, dermatographia, warmth, swelling, tenderness at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/04/2021,8.0,PVT,"Microgestin Fe 1.5/30, Celexa 30mg daily, Iron supplement",none,"depression, iron deficiency anemia",,Sulfa drugs,"['Erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Mechanical urticaria', 'Pruritus']",1,MODERNA,IM 920442,,51.0,F,"Patient reports fever, body aches, headache, and small/mild amount of chest pain",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,,,,,,"['Chest pain', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 920443,FL,34.0,F,"Moderna COVID?19 Vaccine EUA given on 12/26/2020 - No allergic reactions or any expected side effects , except for localized dull back pain in the lumbar region. Eleven days after vaccination (01/05/2021) the pain remains constant. Patient is certain no physical activity or unrelated event caused the back pain. Primary care physician is not knowledgeable if Covid 19 vaccine can cause such pain. Patient was referred to PT and/or acupuncture.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/26/2020,0.0,WRK,None,None,None,,"Dust, cat dander, pollen and soy milk",['Back pain'],1,MODERNA,IM 920445,,27.0,M,"Axillary swelling, severe pain at the site of injection, axillary lymphadenopathy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,UNK,"Humira, Mirtazapine",,"Crohn's Disease, Major Depressive Disorder",,Augmentin,"['Injection site pain', 'Lymphadenopathy', 'Oedema peripheral']",1,MODERNA,IM 920446,WI,61.0,F,Patient received a dose of vaccine that may be less than completely effective due to storage conditions. No adverse effects reported.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/30/2020,4.0,PVT,,,,,,['Product storage error'],1,MODERNA,IM 920447,TX,43.0,U,"Swelling to left forearm, wrist, and hand.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/05/2021,5.0,UNK,Unknown.,Unknown.,Unknown.,,No known allergies.,"['Joint swelling', 'Peripheral swelling']",1,MODERNA,IM 920448,NC,39.0,F,Slight numbness and swelling left side of upper lip half an hour after first injection. Patient observed for an additional 45 minutes after symptoms. Symptoms did not progress. Patient advised to continue to monitor symptoms and if swelling or numbness progress to seek medical attention immediately. Patient returned to work.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,none,none,patient states she had a similar reaction to a flu shot once.,NKDA,"['Hypoaesthesia oral', 'Lip swelling']",1,PFIZER\BIONTECH, 920449,WI,24.0,F,Fever of 101 degrees and headache,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,,,,,,"['Headache', 'Pyrexia']",UNK,MODERNA,IM 920450,TX,91.0,F,"Redness and irritation around the injection site, feels warm to the touch, is sore and aches a little bit.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PHM,"amlodipine 10mg, meclizine 25mg",None,Hypertension,90,No known allergies,"['Injection site erythema', 'Injection site irritation', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 920451,NJ,51.0,F,"achy, chills, fatigue, headache starting a few hours after vaccine. Resolved with sleep, tea and over the counter Sudafed 4 hour night time with ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Tylenol pm the night before - 24 hour, fish oil, vitamin d, magnesium, Colace and collagen",Was achy the night before the vaccine which is why I had taken Tylenol pm. I believed achiness was related to a yoga class I had taken,None,,none,"['Chills', 'Fatigue', 'Headache', 'Pain']",1,PFIZER\BIONTECH,IM 920472,CA,57.0,F,Fatigue Weakness in left leg,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,UNK,,,,,,"['Fatigue', 'Muscular weakness']",1,MODERNA,SYR 920473,CA,1.0,F,"Now dealing with fibromyalgia, anxiety, depression",Not Reported,,Not Reported,Not Reported,,Yes,N,06/17/1993,01/11/2000,2399.0,PVT,None,None,"Anxiety, depression,fibromyalgia",,,"['Anxiety', 'Condition aggravated', 'Depression', 'Fibromyalgia']",3,UNKNOWN MANUFACTURER, 920474,IL,30.0,F,"Body ache, Chills, Headache, Nausea, Sore at Injection Site",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,depro provera,,,,NKA,"['Chills', 'Headache', 'Injection site pain', 'Nausea', 'Pain']",1,MODERNA,IM 920475,GA,46.0,F,"nausea, numbness & tingling of mouth/tongue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,,,,,,"['Hypoaesthesia oral', 'Nausea', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 920477,MO,32.0,F,"12/23/2020 VACCINATION. 20 MINUTES LATER STARTED TO EXPERIENCE AE . MY FIRST REACTION WAS MY HEAD FELT HOT; WAS TOLD IT WAS NORMAL. 21 MINUTES; GOOSEBUMPS, SPREAD OVER ALL OVER BODY. DIDN'T GO AWAY FOR 3 HOURS. ABOUT 25 MINUTES AFTER, ON VITAL MACHINE. BP WAS 185/105 (HIGHEST EVER, ABNORMAL). FULL ALLERGIC REACTION. RUSHED TO ER. BENADRYL, PREDNISON. ITCHING STARTED, HIVES. STARTED TO GET SUPER ITCHY. HAS BEEN ON AND OFF FROM THEN TO PRESENT DAY. 12/24/2020 SENT HOME. ACHINESS AT SITE. WORST DAY OUT OF ALL OF THEM. I COULDN'T EVEN SIT UP; I FELT LIKE I HAD 'RIGAMORTOUS', COULDN'T EVEN MOVE MY PINKY. CALLED INTO WORK, LOST MY BONUS DUE TO THIS. 12/25/2020 - COULDNT MOVE. REGRET VACCINE MORE THEN ANYTHING 12/26/2020 CHILLS. NO FEVER. BODY ACHES. NAUSEA STARTED; SO BAD I DIDN'T EAT FROM DAY 3-DAY 6. LEFT ARM FELT 'DEAD'. 12/27/2020 - SYMPTOMS CONSISTED EACH DAY. SWELLING STARTED ON WHOLE LEFT SIDE OF MY BODY. TRIED TO GO TO WORK. MADE IT 2 HOURS BUT SWELLING WAS SO BAD. SENT TO ER. REFERRED TO DR IN HOSPITAL. PRESCRIBED 7 DAY PREDNISONE. FELT BETTER WITH THE STEROIDS. EVERYTING HAS SLOWLY TAPERED OFF REFERRED TO DR ARM STILL HURTING 11 DAYS LATER, LINGERING AFFECTS",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,,,CLUSTER MIGRAINES,,CONTRAST DYE; ENVIRONMENTAL ALLERGIES,"['Blood pressure abnormal', 'Chills', 'Decreased appetite', 'Feeling hot', 'Hypersensitivity', 'Hypoaesthesia', 'Impaired work ability', 'Injection site pain', 'Mobility decreased', 'Musculoskeletal stiffness', 'Nausea', 'Pain', 'Pain in extremity', 'Piloerection', 'Posture abnormal', 'Pruritus', 'Swelling', 'Urticaria']",1,MODERNA,SYR 920478,LA,54.0,F,"When I first received shot my left arm start hurting. I was in contact with someone that had COVID-19 , which I was tested positive with COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/22/2020,6.0,WRK,"Norvasc, lipitor",None,"Hypertension, Hyperthyroidism",,None,"['COVID-19', 'Exposure to SARS-CoV-2', 'Pain in extremity', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 920480,OH,28.0,F,"About 30-35 mins, after vax, I started noticing my eyes were itching, and I started scratching my face. I got in my car and realized it's not going away. I need advice on what to take for it to go away. I noticed a itchy throat. Not sure if it's something that's due to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,No,No,No,,No,"['Eye pruritus', 'Pruritus', 'Throat irritation']",UNK,PFIZER\BIONTECH, 920481,IN,34.0,F,"Anxiety, clammy skin, minor throat swelling, tachycardia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Allegra Birth Control Pill,none,Seasonal Allergies,,NONE,"['Anxiety', 'Cold sweat', 'Pharyngeal swelling', 'Tachycardia']",1,MODERNA,IM 920482,ME,32.0,M,"Lips began to tingle and then went numb. Face became warm and itchy. Throat scratchy. First signs began about 40 minutes after vaccination and patient went to ER. Was given Slumedrol, Benedryl, & Famotidine in the ER and observed. Symptoms diminished and patient was released the same night.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,Vyvanse,None,Asthma,,Dilaudid,"['Feeling hot', 'Hypoaesthesia oral', 'Paraesthesia oral', 'Pruritus', 'Throat irritation']",1,MODERNA,IM 920483,TX,36.0,F,"Begin with localized tenderness and pain at injection site. Progressed to joint pain in the arm, loss of strength, tenderness and inability to move arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,Accutane 40 mg daily,acne,acne,,none,"['Arthralgia', 'Asthenia', 'Hypokinesia', 'Injection site pain']",1,PFIZER\BIONTECH,IM 920484,MO,61.0,F,severe vertigo could not lift head off pillow without retching lasted 12 hrs,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,PVT,,,,,sulfa,['Vertigo'],1,MODERNA,SC 920487,PR,59.0,M,"Low grade fever , joint and muscular pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,None,Hypertension,Hypertension,,Crab,"['Arthralgia', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 920488,MO,65.0,F,Red rash a little larger than Silver Dollar with a white ring around it.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PHM,"Atenolol, Alosetron, Losartan, Mirtazapine, quetiapine, fluoxetine, pantoprazole, Meclizine, Melatonin, Atomoxetine",None known,"IBS, Hypertension, Dislipidemia, Major Depressive Disorder, Vertigo, Acid Indigestion, Insomnia, ADD, Interstitial Cystitis",,No Know Allergies,"['Rash erythematous', 'Skin discolouration']",1,MODERNA,IM 920489,PA,31.0,F,"Tenderness, warmth, redness and swelling at injection site starting 24 hours post vaccine and self-resolved within 5 days post vaccine. Did NOT require treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 920490,MT,30.0,F,"Very sore arm, swollen. No bruising or redness. Resolved in 2 days. In comparison received Boostrix and quad flu in the past with no soreness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,UNK,"Nuvaring, escitalopram 10mg",na,na,,knda,"['Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 920491,IN,49.0,F,Itchy rash developed on extremities and buttocks.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/22/2020,5.0,PVT,"Zyrtec, Xyzal, Advair",none,"asthma, allergies",,PCN,"['Rash', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 920492,TN,28.0,M,Very similar symptoms to Renault?s syndrome. Pain and tingling in feet after exposure to cold water or ambient cold. It causes numbness and tingling in the extremities.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PUB,None,None,ADHD depression,,None,"['Hypoaesthesia', 'Paraesthesia']",1,MODERNA,SYR 920493,MA,55.0,F,"PATIENT CAME IN TO GET FIRST DOSE MODERNA VACCINE AT APPROXIMATELY 1430, IMMEDIATELY AFTER DOSE GIVEN PATIENT SAID SHE HAD A ""METALLIC TASTE"" IN HER MOUTH BUT FELT FINE. AFTER SITTING FOR HER OBSERVASTION TIME, PATIENT STOOD UP AND BECAME SLIGHTLY DIZZY. BLOOD PRESSURE TAKEN WHICH WAS NORMAL FOR THE PATIENT, IN ADDITION PATIENT SAID SHE FELT FINE THROUGHOUT. PATIENT WAS GIVEN A CUP OF WATER AND WAS ABLE TO STAND AND WALK OUT OF CLINIC WITH NO ISSUE.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Unknown,Unknown,Unknown,,Percocet (nausea / vomiting) Bactrim (vomiting),"['Dizziness', 'Dysgeusia']",1,MODERNA,IM 920494,NY,37.0,F,"Rash at injection site developed one week after receiving the vaccine. Rash is hot to the touch, a bit hard, and slightly itchy. Not sure if this is related but have a lot of muscle soreness and discomfort in upper back/neck/shoulder area since Sunday 01/03",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,"Vyvanse 60mg Wellbutrin 300mg Lexapro 10mg Vylacyclovir 1/2 mg Glycopyrrolate 1mg (took for the first time on 01/04/21 - prescribed to help with sweating caused by antidepressants) 2,000 IU of Vitamin D3 Garden of Life Vitamin Code multivit",,"depression, anxiety, PTSD",,"Intolerances: wheat, corn, walnuts, sesame, diary","['Injection site induration', 'Injection site reaction', 'Injection site warmth', 'Musculoskeletal discomfort', 'Myalgia', 'Rash pruritic']",1,MODERNA,IM 920495,TN,57.0,F,"Took aleve prior to receiving vaccine. Has known allergy to celebrex which causes mouth/lips to swell and break out in hives. Approx. 45 minutes later she became flushed, felt lightheaded/intoxicated/giddy/silly while driving home. She said she was extremely hungry (""like a big dose of steroids""). She states her ears were ringing and when she laid down at 2130 she could feel her heart beating throughout her body. This AM she reports feeling ""hungover/groggy/nauseated"". She denied any lip/tongue swelling, any lip or extremity tingling, difficulty breathing, any injection site redness/heat/swollen/painful area, fever, chills, or ever having a vaccine reaction previously. Spoke with individual w/pharmacy. Advised to report to VAERS. Not an expected reaction. Possibly related to aleve vs. covid vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Aleve prior to vaccine. Takes Omeprazole daily, Biotin supplement",None,Hx- had Covid in August. Also reports hx of vertigo,,Celebrex- causes mouth/lips to swell and break out in hives,"['Dizziness', 'Feeling abnormal', 'Flushing', 'Hangover', 'Hunger', 'Nausea', 'Tinnitus']",1,PFIZER\BIONTECH,IM 920496,OR,53.0,M,"hx of anaphylaxis to MMR. during prolonged observation period developed sensation of heat across chest and into throat, and lip felt numb. had taken Benadryl prior to arriving to clinic. Started to improve but with concern of symptoms worsening once Benadryl wears off, he was directed to the ER by private auto. not permitted to drive himself, wife came and picked him up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,unknown,unknown,unknown,MMR,unknown,"['Chest pain', 'Hypoaesthesia oral', 'Throat irritation']",1,MODERNA,IM 920497,MO,49.0,M,"Dec 26 woke up at 0400 with fever 101.6 , chills, sever headache, body aches and very dizzy and nauseated sick for 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,12/26/2020,2.0,PVT,,,,,compazine,"['Chills', 'Dizziness', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,SC 920498,NY,34.0,M,"Patient complained of feeling dizzy after receiving vaccine. Patient stated he needs to lie down. Patient diaphoretic placed on stretcher. BP 105/65, HR 64, RR 14, SP02 95% RA. Patient felt better in stretcher. Talking",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,History of vasovagal responses when receiving shots,,No known Allergies,"['Dizziness', 'Hyperhidrosis', 'Hypotension']",1,MODERNA,IM 920499,TX,34.0,F,"Vaccine at 1600hrs on 1/4/2021. Had hives, itching, arm soreness, chills, and body aches, at 1800hrs 1/4/2021. Could not sleep all night. Took Clear fast acting allergy relief 30ml next morning (1/5/2021). Hives and itching started on left wrist then right wrist. It then progressed to all over her body. She says it is like when she has a reaction to PCN.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PUB,Tylenol,No,Asthma,,PCN,"['Chills', 'Insomnia', 'Limb discomfort', 'Pain', 'Pruritus', 'Urticaria']",1,MODERNA,IM 920501,CA,50.0,F,"At 6:00 am on 1/5/2021, I woke up with a swollen face. Took a Benadryl. At 0630 I started vomiting Some SOB and wheezing I feel better after vomiting, Benadryl, and inhalers",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,Levothroid Glioizide Metformin Inhalers,None,Asthma Prednisone induced high blood sugar IBS Allergies to grass and dust,Influenza vaccine sick with asthma for 10 days,Contrast Dye Erythromycin,"['Dyspnoea', 'Swelling face', 'Vomiting', 'Wheezing']",UNK,MODERNA,IM 920502,SC,56.0,F,"Developed a rash in the evening after dose #1...in the wrist area, circular around entire wrist...looks like a contact dermatitis. Left wrist Topicals not helping. Wears a watch on that wrist, but not that day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,unknown,unknown,unknown,,unknown,['Rash'],1,PFIZER\BIONTECH,IM 920503,TX,42.0,M,"Empoyee received his 1st dose of Covid-19 vaccine around 1535 on 12/17 at our vaccination clinic. Around 1545, while being monitored by a registered nurse, he leaned over and grabbed his head. The nurse asked if he was okay and he reported, ""no"". He stated that he felt nauseated. V/S obtained: B/P 158/80; pulse 99; resp 24; O2 sat 99% on RA; FSBS 267. Pupils were slow to react. Skin was flushed and red. Dr. was notified and assessed the employee. At 1558, the Dr. ordered Benadryl 50mg IM. This was given to employee in Left Deltoid IM at 1558 by RN. At 1559, patient complained of heache, chest tightness, being cold. At 1606, O2 sat was 99% on RA; B/P was 126/90. He reported that his headache was going away at that time and that the chest tightness was going away as well. Headache at that time was a 4/5 on pain scale. Recommended that he be checked at the ER. Between 1620-1625, first responders on site. At 1630, employee was transported to ER for evaluation. Status at time of transfer: Alert and Oriented; headache better, nausea getting better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,UKN,Did not disclose anything,Diabetes; hadn't ate all day.,,No known allergies,"['Chest discomfort', 'Erythema', 'Feeling cold', 'Flushing', 'Headache', 'Nausea', 'Pupillary reflex impaired']",1,PFIZER\BIONTECH,IM 920504,MO,27.0,F,"Fever, chills, redness, swelling and tenderness at injection site, hardned knot at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,PVT,,,,,Penicillin,"['Chills', 'Injection site erythema', 'Injection site nodule', 'Injection site pain', 'Injection site swelling', 'Pyrexia']",1,MODERNA,IM 920505,CT,39.0,F,"Several minutes following vaccine c/o feeling flushed and ""really hot."" She was hypertensive and tachycardic throughout the monitoring period following vaccine. She c/o headache, nausea, hot and cold, flushed, noted blotchy skin and shaking hands (noted prior to vaccine) Evaluated by physician on site and spouse was called to transport patient home. She was given instructions on when to return to the ED",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,Augmentin - hives,"['Feeling hot', 'Flushing', 'Headache', 'Hypertension', 'Nausea', 'Rash macular', 'Tachycardia', 'Tremor']",1,MODERNA,IM 920506,FL,31.0,F,"Red, hot, swollen arm within 12 hours. Subsided within approximately 48 hours. Reemerged hot, red, and itchy at day 7 post vaccine. Day after extreme fatigue and headache. Subsided within 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"Yaz, Nexium, Singulair, Zyrtec, Lexapro, Buspar",None,"Asthma, allergies, GERD",,"Penicillin, Z-pak","['Erythema', 'Fatigue', 'Headache', 'Peripheral swelling', 'Pruritus', 'Skin warm']",1,MODERNA,IM 920507,PR,38.0,F,PTE PRESENTA MAREOS Y BP ELEVADA. POR LO QUE REQUIERE SER EVALUADA POR MD DE TURNO.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,PVT,,,,,CODEINA,"['Blood pressure increased', 'Dizziness']",3,PFIZER\BIONTECH,IM 920508,NY,45.0,M,"Pain at site of injection, fatigue, headache, muscle aches, chills, fever, injection site swelling, and nausea. Symptoms faded after 24 hours. Tylenol was taken for 102.4 fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,None,none,none,,None,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,IM 920509,MD,28.0,F,"Moderna COVID-19 Vaccine EUA 12/31-30 minutes after vaccine, headache, lightheaded, hot flashes (all day) 1/1- headache, nauseated, chills, lower back pain (all day) 1/2-headache, hot flashes (all day) 1/3-headache (all day) 1/4-headache (all day) 1/5-mild headache took NSAIDS and Acetaminophen everyday, all day long- no headache relief",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Multi-vitamin, Zoloft",none,none,,none,"['Back pain', 'Chills', 'Dizziness', 'Headache', 'Hot flush', 'Influenza virus test negative', 'Nausea', 'SARS-CoV-2 test negative']",1,MODERNA,IM 920510,TX,64.0,F,"Vaccine given on 12/17/20 went to ER on 12/18/20 . Started having diarrhea at 4am on 12/18/2020. Came in to work and felt short of breath and heart rate increased. She went to the ER. She was given a liter of fluid 0.9% NACL IV, and per employee all symptoms resolved and she was discharged. She reports no further problems.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,"Lisinopril, Liothyronine, insulin lispro",,"diabetes, hypertension",,compazine,"['Diarrhoea', 'Dyspnoea', 'Full blood count normal', 'Heart rate increased', 'Metabolic function test', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 920511,MA,60.0,F,"Patient vaccinated at 0910, reported ""feeling lightheaded and dizzy"" around 0940. This RN assessed patient and took VS (O2sat: 100%, BP: 120/74 (RUA), RR: 16, HR: 67 bpm). Patient remained seated and was provided with water. Patient states she had not drank water at all this morning. Patient reported feeling better with no further adverse reactions and left observation room at 0949.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,Multiple thyroid nodules Myopia of both eyes with astigmatism and presbyopia Benign neoplasm of colon Varicose veins Lower abdominal pain S/P TAH (total abdominal hysterectomy),,NKA,['Dizziness'],1,MODERNA,IM 920512,NY,23.0,F,"cellulitus on left arm at injection site, fever for 24 hours, pain, cellulitus lasting a week that spread to another area of arm that was hot to touch and itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,WRK,"propanalol, zetia, liptior, prozac, buspar, fioriset, maxalt, zolfran, ibuprofen",,"familiar hypercholesteralemia, depression, anxiety, obesity, chronic migraines",,sulfa,"['Cellulitis', 'Injection site cellulitis', 'Pain', 'Pruritus', 'Pyrexia', 'Skin warm']",1,MODERNA,SYR 920513,FL,53.0,F,"Serious fatigue, runny nose, then into severe body aches and couldnt get warm and then waking in mid of night severly shivering for an hour and a half, temp was 100 f all the while taking 800mg ibuprofen q 6hrs since vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,"Metoprolol succinate 50mg one tab at night. Claritin 10 mg at night. Docusate 3 capsules daily. Omeprazole 20mg at night. Vit C,D, Zinc. Biotin. 800 mg Ibuprofen every 6 hrs. ( started ibuprofen doses an hour after vaccination)",None - But had severe Covid end of June 2020 to the beginning of Aug 2020,History of Perimyocarditis once back in 2017,,"Sulfa, losartan","['Body temperature increased', 'Chills', 'Fatigue', 'Feeling cold', 'Pain', 'Rhinorrhoea', 'Sleep disorder']",1,MODERNA,IM 920514,ME,57.0,M,"$ hours following the vaccination, I felt very faint and dizzy and nearly passed out. I checked my blood pressure, which was normal. My pulse rate was low (58). I remained dizzy and weak for the rest of the day, with some nausea, but no vomitting. My dizzyness and weakness gradually dissipated over the next 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,omeprazole,,GERD,,none,"['Asthenia', 'Dizziness', 'Heart rate decreased', 'Nausea', 'Presyncope']",UNK,MODERNA,IM 920515,GA,39.0,F,Patient having extreme chills starting at 6am. She took anti-inflammatory and came to work. Temp 97.8,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,metoprolol BCP,none,Raynauds,,none,['Chills'],2,PFIZER\BIONTECH,IM 920516,MI,38.0,F,"I felt fine initially just so soreness of my arm. The next day I started with the chills and a little bit of the headache, I just kinda figured it was a response to the vaccine and did not think much of it. Through the night I had fever (100.8F), chills and headache. I took some Excedrin and Wednesday morning I felt ok. I decided to go to work but the screening told me because I had fever in less than 24 hrs I could not go to work I had to report to the COVID hotline. They sent me to get tested because of the fever. I got tested at hospital and was tired the rest of the day but no fever and the next day I was ready to go to work but I had to wait for the test results that would come 24hrs later. The test came back positive. So I could not return to work until yesterday.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,"Metoprolol, Norvasc, Vitamin C and D3, Zinc, Multivitamin, B Complex",no,HBP,"with the flu vaccine I feel a little congested, a little sick nothing serious",shellfish,"['COVID-19', 'Chills', 'Headache', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,SYR 920518,KY,42.0,F,Quarter size knot on arm followed by a red rash at injection site. Arm is hot to touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/30/2020,8.0,PVT,"Multi-vitamin, Dymista nasal spray, allergy shots given every two weeks for seasonal allergies",,,,"mold, various tree pollens","['Injection site nodule', 'Injection site reaction', 'Injection site warmth', 'Rash erythematous']",1,MODERNA,IM 920519,KY,43.0,F,"On 12/31/2020 patient noticed a ""Golf ball sized"" knot behind collarbone on left side (side vaccinated). She did go see her PCP because she didn't know what the knot was. She was told that it was possibly a swollen lymph node. She does have a follow-up appointment with PCP for further evaluation. She reports that it is getting better with each day. No treatment rendered by PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PUB,"Singulair & advair inhaler,",None,Asthma and requires daily medication.,,Penicillin,['Nodule'],1,MODERNA,IM 920520,MO,40.0,F,"Mild itching and tongue tingling at tip. Vital Signs 0746 - BP 112/79, HR 74, RR 18, Temp 98.4, SPO2 100% Vital Signs 0812 - BP 113/74, HR 78, RR 18, Temp 97.2, SPO2 99% Benadryl administered 0749 by, RN",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Paraesthesia oral', 'Pruritus']",1,MODERNA,IM 920522,MI,48.0,F,1/1/21 thru 1/3/21 body chills fever 101-102 temp 1/3/21 @ 4am fainted with temp of 101.5,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,,allergies,allergies,,"Walnuts, pollen, ragweed, cats, dogs, horses","['Chills', 'Pyrexia', 'Syncope']",1,MODERNA, 920523,MO,47.0,F,"Pt reported itchiness and tingling on her neck and back around 20 minutes after receiving vaccine. Pt given 25 mg of diphenhydramine tab, and she refused 2nd diphenhydramine tab. Pt reported cessation of itchiness and tingling 20 minutes after receiving diphenhydramine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Paraesthesia', 'Pruritus']",1,PFIZER\BIONTECH,IM 920525,PA,49.0,F,Pain and swelling at injection site - 12/31/2020 to 1/2/2021 Decreased Pain and itching at injection site - 1/3/21 to present ******************************************************************** Headache - 12/30/2020 to present Fatigue/Tiredness - 12/30/2020 to present Arthralgia and Myalgia - 12/30/2020 to present Dizziness (Mild to Moderate) - 12/30/2020 to present Dry cough - 12/31/2020 to present Sore Throat - 12/31/2020 to present Swollen glands (Mild to Moderate) - 12/31/2020 to present Nausea - 12/30 and 12/31/2020 Diarrhea - 12/31/2020 Fever - 1/1/21 (1.6 degrees F above patient baseline) 1/3/21 (1.7 degrees F above patient baseline) 1/5/21 (1.4 degrees F above patient baseline) Chills - 1/1/21 to present,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,"Protonix 40mg daily Atorvastatin 40 mg daily Escitalopram 10 mg daily Ajovy 225 mg/1.5mL every 30 days PRNs: Acetaminophen 1 g q 6 hours, Ibuprofen 800 mg q 6 hours, Ondansetron ODT 4 mg q 8 hours, Cyclobenzaprine 5 mg q 8 hours",,"GERD, IBS, migraines",,"PCN - anaphylactic Codeine - urticaria Sulfa drugs - profuse vomiting and other GI disturbances Latex - anaphylactic Adhesives - topical dermatitis stinging insects - anaphylactic poisons: ivy, oak, and sumac - anaphylactic at times or extreme hypersensitivity to skin leading to burning, scarring, etc. Foods: onions, peppers, tomatoes, corn, milk Trees and flowers - pretty much all but worst are mums, roses, evergreens","['Arthralgia', 'Chills', 'Cough', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Lymphadenopathy', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Pyrexia']",1,MODERNA,IM 920526,CT,42.0,F,"I had the normal shoulder pain for a couple days. Then day 6 developed extreme malaise with nausea. I kept saying it felt like my whole body was floppy and melting into the couch, and I couldn?t motivate to stand or do anything for 24 hours. Then myalgias and nausea continued for 2 days. Around the same time as the malaise, I developed a palpable indurated area under the vaccine site. Then day 8 my entire shoulder swelled up with overlying red leathery skin and axillary pain but no adenopathy. Day 10, back to normal except for some residual red pruritic skin extending down my arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/25/2020,12/31/2020,6.0,PVT,none,none,none,,keflex - hives mastisol - severe contact dermatitis,"['Apathy', 'Arthralgia', 'Axillary pain', 'Dry skin', 'Dysstasia', 'Erythema', 'Hypotonia', 'Malaise', 'Myalgia', 'Nausea', 'Peripheral swelling', 'Pruritus', 'Vaccination site induration']",UNK,MODERNA, 920527,IN,42.0,F,"headache, body/joint aches, sore lymph nodes, extreme chills, swelling at injection site, pain at injection site, redness at injection site, and nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Xyzal, Cymbalta 60mg",None,Depression,redness/swelling at injection site,Dyclofenac,"['Arthralgia', 'Chills', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Lymph node pain', 'Nausea', 'Pain']",1,MODERNA,IM 920528,MN,28.0,F,"fever, aches, headache began 2 hours after vaccination but persisted over 48 hours. Tested for COVID per employee health policy on 12/31 - negative. Rash began 2 days after vaccination. was seen at Urgent care on 1/2/21, given prednisone. Rash worsened, fever broke. seen again 1/3/21 - given kenalog shot. tested for COVID-19 (negative). Rash continues to spread, headache improved but not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,Iron supplement,ear infection 2 weeks prior - was treated with amoxicillin,none,,none,"['Headache', 'Hyperglycaemia', 'Liver function test increased', 'Lymphopenia', 'Pain', 'Pyrexia', 'Rash', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 920529,MO,46.0,F,"warm, painful to touch tightness of the skin, and itching ibuprofen and tylenol have been used, and ice packs to the area called employee health to notify January 1, 2021 at 3:40 pm. and left a message spoke with Staff in employee health on January 4th, informed of symptoms and was advised to fill out the RL and if symptoms persists call my primary physician",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Pain of skin', 'Pruritus', 'Skin tightness', 'Skin warm']",UNK,MODERNA, 920530,,63.0,F,"I am letting you know that I had the first in the 2 part series of the COVID vaccine (Moderna) yesterday (Jan. 4, 2021 at 1500) afternoon. I woke this morning with side effects of fatigue, body aches, mild chills, increased cough, and loss of appetite.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,MIL,None- occasional ibuprofen or acetaminophen,"I had tested positive for COVID on December 22 and quarantined until December 31 (date it started was determined to be Dec. 20.) I didn't have as much aching then as I do now, which seems odd to me. I'm letting you know for your records.",None,,None,"['Chills', 'Cough', 'Decreased appetite', 'Fatigue', 'Pain']",1,MODERNA, 920531,GA,61.0,F,"ITCHY, RED, RAISED AREA AT INJECTION SITE ABOUT A WEEK OUT. ABOUT 4CMX 3CM.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,HORMONE REPLACEMENT THERAPY,NONE,NONE,,NONE,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 920532,OH,62.0,F,Fever : 100 at 7:30 am after Advil at 3:30 am; fever now 99.7 Headache Cold/ achy Very slight cough (normal),Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Zn/coppr/lutein/zeaxan (PRESERVISION AREDS-2 PO fluticasone propion-salmeteroL 100-50 mcg/Puff inhaler Commonly known as: Wixela Inhub - Advair azelastine 137 mcg (0.1 %) Spray triamterene-hydrochlorothiazide 37.5-25 mg per tablet FLUoxetin,"Asthma High Blood Pressure COVID-19 tested positive 11/16/20, sick until at least 12/16/20",Asthma High Blood Pressure,,none,"['Cough', 'Headache', 'Nasopharyngitis', 'Pain', 'Pyrexia']",1,MODERNA, 920533,NY,45.0,M,"Pain at site of injection, fatigue, headache, muscle aches, chills, fever, injection site swelling and nausea. Symptoms subsided in 24 hours. Tylenol was taken for 102.4 fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,None,none,none,,None,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,IM 920534,MO,32.0,F,Stated that within 30 minutes hands and feet swelled,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,PCN,['Peripheral swelling'],1,PFIZER\BIONTECH,IM 920535,KY,37.0,F,"Itching started approx 2 hours after administration. Developed redness, swelling, pain and heat, progressively getting worse.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,Effexor,None,None,,None,"['Erythema', 'Pain', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,IM 920536,,30.0,F,"Chills, nausea, rapid heartrate, dizziness, injection site pain. No relief of symptoms yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,Sprintec,,,,NSAIDs,"['Chills', 'Dizziness', 'Heart rate increased', 'Injection site pain', 'Nausea']",1,MODERNA,IM 920537,AZ,67.0,F,Intense itching in an area about two inches below injection site which started about six days after the first injection of Moderna vaccine. Also swelling ( a firm lump). Itching intense enough to disrupt sleep. Over the counter remedies did not help. Cold pack did not help.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,PHM,,,,Shingles vaccine. Also intense itching at site of injection. Age 60.,,"['Injection site induration', 'Injection site mass', 'Injection site pruritus', 'Injection site swelling', 'Sleep disorder']",1,MODERNA,IM 920538,TX,65.0,F,"12/31/20 extreme heavy drowsiness, sleepiness. Pt collapses and fell asleep after arriving home, Pt awoke 5-6 hrs later, feeling unwell body aches, headache, sinking feeling, restlessness , flushed feeling, 106. fever, loss appetite, bad taste in mouth weakness, congestions and Phlegm in lungs, sore arm also . Symptoms continue, feeing extreme restlessness and headache persists. Tylenol and ibuprofen taken for fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,OTH,"Morphine every 12 hrs, gabapentin",Sinus infection - cold,body pain,,,"['Asthenia', 'Decreased appetite', 'Depressed mood', 'Flushing', 'Headache', 'Malaise', 'Pain', 'Pain in extremity', 'Productive cough', 'Pulmonary congestion', 'Pyrexia', 'Restlessness', 'Somnolence', 'Syncope', 'Taste disorder']",1,MODERNA,IM 920539,MA,33.0,F,"Immediate onset of numbness and tingling in 4th and 5th digits, left hand. Followed by a burning pain Seen via telehealth 12/30/20 Recommended conservative measures Started on NSAIDs Examined 1/4/21 Script for PT provided",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,None,None,None,,None,"['Hypoaesthesia', 'Immediate post-injection reaction', 'Pain', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 920541,NE,17.0,F,"DEVELOPED HEADACHE, FEVER, CHILLS, BODY ACHES, NAUSEA. RESOLVED BY MORNING OF 12/31/20",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,SEN,,,,,,"['Chills', 'Headache', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,IM 920542,MO,59.0,F,"Mild itching and tingling Vital Signs 0708 - BP 146/85, HR 73, RR 16, Temp 97.3, SPO2 99% Vital Signs 0730 - BP 142/100, HR 77, RR 16, Temp 97.0, SPO2 99% Vital Signs 0750 - BP 152/89 Benadryl administered at 0715 by RN",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,PVT,,,,,"Milk, Egg, Chicken","['Paraesthesia', 'Pruritus']",1,MODERNA,IM 920543,AR,45.0,F,Immediately after shot for 20 minutes was tasting metallic taste and tingling in right pinky and ring finger. Around 11 pm started having metallic taste and cannot get rid of it. Woke up in middle of the night having diarrhea which still having symptoms this morning.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Remfresh only medication taken 1/2 tablet,,Migraines,,,"['Diarrhoea', 'Dysgeusia', 'Immediate post-injection reaction', 'Paraesthesia']",1,PFIZER\BIONTECH, 920545,SD,93.0,M,"The resident received is vaccine around 11:00 am and tolerated it without any difficulty or immediate adverse effects. He was at therapy from 12:36 pm until 1:22 pm when he stated he was too tired and could not do anymore. The therapist took him back to his room at that time and he got into bed himself but stated his legs felt heavy. At 1:50 pm the CNA answered his call light and found he had taken himself to the bathroom. She stated that when he went to get back into the bed it was ""abnormal"" how he was getting into it so she assisted him. At that time he quit breathing and she called a RN into the room immediately. He was found without a pulse, respirations, or blood pressure at 1:54 pm. He was a DNR.",Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,SEN,"Ferrex 150 mg, Folic Acid 1 mg, Furosemide 20 mg, Isosorbide Mononoitrate ER 30 mg, Lactulose 15 mL, Omeprazole 40 mg, Potassium Chloride ER 20 MEQ, Metoprolol 12.5 mg, PreserVision AREDS 2 one capsule, Ranolazine ER 1,000 mg, and Sucralf",,"ACUTE POSTHEMORRHAGIC ANEMIA, ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITH OTHER FORMS OF ANGINA PECTORIS, CARDIAC MURMUR, UNSPECIFIED, CHRONIC KIDNEY DISEASE, STAGE 2, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, EMPHYSEMA, ESSENTIAL (PRIMARY) HYPERTENSION, FRACTURE OF NASAL BONES, INITIAL ENCOUNTER FOR CLOSED FRACTURE, HYPOXEMIA, PAROXYSMAL ATRIAL FIBRILLATION, PRESENCE OF CARDIAC PACEMAKER, THROMBOCYTOPENIA, UNSPECIFIED CIRRHOSIS OF LIVER, and UNSPECIFIED DIASTOLIC (CONGESTIVE) HEART FAILURE.",,NKA,"['Abnormal behaviour', 'Blood pressure abnormal', 'Fatigue', 'Limb discomfort', 'Pulse absent', 'Respiratory arrest']",1,PFIZER\BIONTECH,IM 920546,WI,38.0,F,"Moderna 8:20 am right digits 4&5 were numb for 5-10 min 8:50 am neck was stiff once stood up to leave; lasted 5 min 10:40 am anterolateral redness/rash on right side of neck (along SCM); 2"" long x 1/2"" wide; lasted less than an hour 11:15 am neck rash almost gone; right arm sore at injection site noon - difficulty moving right arm rest of the day; able to achieve full flexion, but ABD was a challenge and body would try to compensate with shoulder hiking; kept arm moving; this soreness and difficulty moving did not go away until woke up next day 11 pm unable to sleep on right arm 1/1/21 woke up with soreness mostly gone, but able to move right arm 1 pm small cough for about 1-2 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"birth control, probiotic, calcium and vitamin D",none,thrombocytopenia (worse with pregnancy) and mild Gilbert's syndrome,,whole body rash with bactrim,"['Cough', 'Erythema', 'Hypoaesthesia', 'Mobility decreased', 'Musculoskeletal stiffness', 'Pain in extremity', 'Rash', 'Sleep disorder']",1,MODERNA,IM 920547,,40.0,F,"Following vaccination, patient reported throat scratchiness in the right side. She has had previous allergic reactions to allergy shot and stated that this is how she felt before. VS: 0740- HR 127, O2 100%, BP 127/75. 0752- HR 100, O2 100%, BP 134/82. 0805- HR 103,O2 100%, BP 159/80. Patient evaluated by physician and monitored in clinic for additional 30 minutes. 0841 HR 104 O2 98 BP 135/77; 0847 HR 100 O2 100 BP 136/73. Discharged from clinic. On 1/4/21 patient presented to urgent care reporting that over the course of the evening and next day she developed intermittent fevers with a T-max of 103 degrees as well as headache and lightheadedness. She has had intermittent symptoms ongoing since her vaccination prompting her to come for evaluation at urgent care. She denies difficulty swallowing. She had been intermittently taking antihistamines. Positive for sore throat. COVID antigen testing was negative, patient discharged.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,PVT,,,,,"banana (anaphylaxis), Bee stings (anaphylaxis), melon (itching and vomiting), omeprazole (numbness and tingling in lips), reaction to allergy shot","['Dizziness', 'Headache', 'Oropharyngeal pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Throat irritation']",1,PFIZER\BIONTECH,IM 920549,NY,65.0,F,"8 hours later, arm was numb/asleep and ice cold, sat up and started to feel better. Woke up in the morning with headache, fatigue, dizziness continued for 2 days. 3rd day , right hand was ice cold, it comes and goes. Took Benadryl and it works for about an hour then it wears off.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,,eye inflammation a month before,"eye cancer/treated 2002, glaucoma",,"Sulfa, Sulfites, Nickel, latex","['Dizziness', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Peripheral coldness']",1,MODERNA,IM 920550,NJ,35.0,F,Body chills started around 10pm on 1/2/2021 and lasted until 3am 1/3/2021. Night sweat/fever started around 3am 1/3/2021 and lasted until 8am 1/3/2021. Headache started around 9/10am on 1/3/2021 and continued on and off throughout the day. Headache continued on and off throughout the day on 1/4/2021. Headache has resolved itself as of 1/5/2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,None,,Migraines,,Seasonal pollen allergies,"['Chills', 'Headache', 'Night sweats', 'Pyrexia']",1,MODERNA,SYR 920551,MA,21.0,M,"around 0900 pt reported feeling light headed and was diaphoretic. pt appeared pale. given water. vs taken. temp 98.9 PO, heart rate 69-76, RR 18-22, 02 sat 98%. after about 10 minutes and 2 bottles of water pt felt better, color resumed to normal. pt asked to wait the full 30 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,None,,,NKA,"['Dizziness', 'Hyperhidrosis', 'Pallor']",1,MODERNA,IM 920552,TX,30.0,M,"After vaccination, employee went to the monitoring area. Around 1450, he complained of nausea and then began to vomit. He then began to c/o flushing, itching, headache, chest tightness, and SOB. Symptoms began approximately 10 min. after immunization. V/S: 126/82; pulse 103; resp 20; O2 sat 99% on RA; pupils equal and reactive. Dr. was notified and assessed the employee. Dr. ordered Benadryl 50mg IM at 1455. This was administed by RN to Left Arm. At 1505, FSBS was 87; O2 sat 98% on RA, pulse 97. At 1510, O2 sat was 98% on RA; pulse 90. At 1520, O2 sat was 98% on RA and pulse 98. Employee continued to vomit. Lungs were clear upon assessment. Skin was pink. At 1528, employee reported that the symptoms were about the same...maybe waxing and waning. Dr. ordered Zofran 4mg SL which was administered at 1528. At 1530, O2 sat was 98% on RA; pulse was 90; B/P was 122/90. At 1540, O2 sat was 96% on RA; pulse 88 - rechecked on Right hand which gave a reading of O2 sat of 98% on RA; pulse 94. At 1545, employee reported improvement of headache, itching, chest tightness, flushing, and SOB; however, was still vomiting almost coninuously. At 1550, O2 sat was 99% on RA; pulse 83. At 1600, B/P was 118/84; pulse 78; resp 20; O2 sat 98% on RA. He continued to vomit. At 1613, employee was taken via wheelchair to private vehicle of a friend and was taken to ER for evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,UNK,UNK,UNK,,UNK - Did not disclose any.,"['Chest discomfort', 'Dyspnoea', 'Flushing', 'Headache', 'Nausea', 'Pruritus', 'Vomiting']",1,PFIZER\BIONTECH,IM 920553,MD,46.0,F,"swelling, redness, itching",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/03/2021,6.0,WRK,Synthroid,none,hypothyroid,,none,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA,IM 920554,ME,31.0,F,"Nausea, dizziness, lightheaded, warmth",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PHM,"Fluoxetine 20mg once daily, Multivitamin once daily",None,Depression,,None,"['Dizziness', 'Feeling hot', 'Nausea']",1,MODERNA,IM 920555,MD,44.0,F,"1/3: near syncope about 4 hours after receiveing vaccine 1/4: near syncope around 6pm, followed by joint paint, chills, fatigue, nausea, headacheInjection site extremely sore on movement.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,none,none,none,,none,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Presyncope']",1,MODERNA,IM 920556,MO,40.0,F,Fever and chills 12 hours after injection,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,,,,,"Ceclor, Penicillins, Bactrim DS","['Chills', 'Pyrexia']",1,PFIZER\BIONTECH,IM 920557,TX,50.0,F,"After vaccine she felt flushed, heart rate 99 bp 181/105. Sent to ER. She reported chest tightness and palpitations while in the ER. Given Benadryl and discharged stable. She reported that her heart rate went up again for a few minutes that night at home and next day and then she was fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,bioidentical hormones,no,no,,no,"['Chest discomfort', 'Flushing', 'Heart rate increased', 'Palpitations']",1,PFIZER\BIONTECH,IM 920558,IN,49.0,F,"By evening I began running a fever (101-102), headache, body ache, general malaise. I went to bed around 10 pm, I woke the following day around 4pm. This is very unusual for me. Confined to not feel well into the next day , but by that evening I felt better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Estradiol, amitriptyline, Claritin, tizanidine, frova",None,Migraines,,"Sulfa, some triptans","['Headache', 'Hypersomnia', 'Malaise', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 920559,MI,58.0,F,"24 hours after vaccine developed fever (101), body aches, fatigue. 10 days later still with low grade fever (100.3) and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/28/2020,1.0,PVT,Celexa,None,none,,None,"['Fatigue', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH,IM 920561,CA,56.0,F,2nd day started having muscle aches 3rd day mild headaches Severe headaches sore throat,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,UNK,,,,,,"['Headache', 'Myalgia', 'Oropharyngeal pain']",1,MODERNA,SYR 920562,,73.0,M,Moderna COVID vaccine administered on 12/31/2020 and the person had a couple of hyperglycemia episodes over 450 a few days later.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/02/2021,2.0,UNK,,,DM,,,"['Blood glucose increased', 'Hyperglycaemia']",1,MODERNA,IM 920563,OK,46.0,M,I experienced moderate pain in my arm. Also I had body ache and joint pain and what felt like a fever. I also became very tired. I did not take my temperature. The symptoms started the day after the immunization around 4 PM. I went to bed around 8:30 PM (12/31/20)and when I woke up at 8AM (01/01/2021) the symptoms had gone away.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Lipitor, Norvasc, Flonase, and Singulair",NO,"High Blood Pressure, High Cholesterol",,NO,"['Arthralgia', 'Fatigue', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 920564,AR,45.0,F,Immediately upon receiving vaccination had metallic taste and tingling in right hand pinky and ring finger. It went away in 20 plus minutes. Around 11 pm started having metallic taste again and woke up with diarrhea in the middle of the night. Symptoms have not subsided.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Remfresh half tab,,migraines,,,"['Diarrhoea', 'Dysgeusia', 'Immediate post-injection reaction', 'Paraesthesia']",1,PFIZER\BIONTECH, 920565,MO,34.0,F,"Patient had not eaten or drank anything prior to vaccination. Received vaccine at 9:10 am. At 9:25 began feeling dizzy and was pale. BP checked and noted to be: 131/92, 149/102, 154/98, and 149/85. O2 was 99%. Pulse fluctuated between 80 and 101. Was given a drink and a snack. At 9:38 was feeling better and left.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,,,,,,"['Dizziness', 'Pallor']",1,MODERNA,IM 920566,MS,73.0,M,12-15 cm area of erythema area of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/04/2021,13.0,PVT,,,,,,['Injection site erythema'],1,MODERNA,IM 920567,TX,52.0,M,Achy and feverish. Couldn't get out of bed,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Mobility decreased', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA, 920568,,73.0,M,The vaccine administered 12/31/20 and the person had a couple of episodes of hyperglycemia above 450 on 1/2/21,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/02/2021,2.0,UNK,,,DM,,,"['Blood glucose increased', 'Hyperglycaemia']",UNK,MODERNA,IM 920569,GA,38.0,F,"It was extremely painful when I received the vaccine and I immediately felt my fingers tingling. In about 10 min I felt very hot in my face, back and felt like I was going to pass out. My heart was racing, it was about 130. My BP initially was 139 and then 160 after that. I never passed out but I felt those waves with a tingling to my face and my neck as I was going to pass out and I started shaking and my heart was racing and my BP was up and it lasted about 45 min before it started going down. They gave me some Ibuprofen at the Employee health and they kept observing me and it started getting better after 45 min. I still felt the waves of feeling flush and hot and cold and very fatigued.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,"Otesla, Vitamin C, D and Zinc",No,Psorisis,,No,"['Burning sensation', 'Dizziness', 'Fatigue', 'Feeling of body temperature change', 'Hot flush', 'Immediate post-injection reaction', 'Injection site pain', 'Palpitations', 'Paraesthesia', 'Tremor']",1,PFIZER\BIONTECH,SYR 920571,OK,51.0,M,"I felt as if I had blow torches during the 2 hour mark on the lateral thighs, femur bone pain and hip pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,Don't wont to disclose,No,Chronic joint pain,Flu vaccine 1998,No,"['Arthralgia', 'Bone pain', 'Burning sensation']",1,PFIZER\BIONTECH,IM 920572,PA,64.0,M,"Received vaccine in the morning 08:00 am, took acetaminophen 1 GM at 09:00 am due to pain in arm. By 10:30pm, I began having flu like symptoms, (aches, low grade fever, sinus symptoms) took another acetaminophen 1 GM. At 11:00 pm, developed severe rigors that lasted for approximately 2 hours. I am an RN and I have seen many cases of sepsis and felt like I was experiencing similar symptomatology. By 1:45 am, the rigors finally ceased and the body, muscle and joint pain became severe (on a pain scale of 1-10, it was an 8). At 7:00 am, I took another acetaminophen 1 GM, the body pain became much less and I was experiencing a global headache. I do not get headaches, so this was unusual. By 10:00 am, the headache was minimal, body aches were gone, only sinus symptoms persisted.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Zyrtec, Alfusozin, Multivits",none,Single kidney (donated one in 2017),,Environmental,"['Arthralgia', 'Chills', 'Headache', 'Influenza like illness', 'Myalgia', 'Pain', 'Pain in extremity', 'Pyrexia', 'Sepsis', 'Sinus disorder']",2,PFIZER\BIONTECH,IM 920573,CT,56.0,F,"Approximately 20 minutes after vaccine, employee was on the highway driving to work and felt lightheaded. Then felt a strong skipped heart beat, then several more. Has a history of palpitations, but had never felt this before. Stopped after a few minutes. Lightheaded for a few hours afterwards.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,,,History of palpitations,,,"['Dizziness', 'Extrasystoles']",1,MODERNA,IM 920574,PR,31.0,F,HOT RED ZONE WITH SMALL CELLULITE,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/04/2021,6.0,PUB,,,,,,"['Erythema', ""Peau d'orange"", 'Skin warm']",1,MODERNA,IM 920575,WA,48.0,F,Hemiplegic migraine,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PVT,,None,Migraines,,"Sulfa, latex, adhesive, celebrex","['Condition aggravated', 'Hemiplegic migraine']",1,PFIZER\BIONTECH,SYR 920576,IL,43.0,F,"Fatigue, Sore to injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,None,None,None,,None,"['Fatigue', 'Injection site pain']",1,MODERNA,IM 920577,NY,66.0,F,"Two days after shot I noticed redness at injection site. No soreness at this time, some itching. No fever no other symptoms. As of today (1/4/21)redness it still there and area seemed to expand, still little itching. Arm does not appear swollen. No other symptoms. Received i injection on 12/23/20. Concerned about length of time this is still present.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/25/2020,2.0,SEN,B12 Advair omeprazole atorvastatin Jardiance Bupropion amlodipine aspirin baby,none,Vitamin D deiciency Obesity Eczematoid Dermatitis Asthma Gerd Type 2 Diabetes mellitus Hypertension High cholesterol igh blood pressure,"shingles vaccine, Feb 2020 Zoster (Shingrix)redness at injection site",metformin Cat dander,"['Injection site erythema', 'Pruritus']",1,MODERNA,SYR 920578,NJ,36.0,F,"Patient reported breaking out with hives, scattered on trunk and arms, continuing 5 days post vaccination. No difficulty breathing or any other symptoms reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PHM,Unknown,None reported,None reported,,None reported,['Urticaria'],1,PFIZER\BIONTECH,IM 920580,TX,30.0,M,"Approximately around 1450, 10 minutes after injection, while in monitoring area, employee started c/o nausea and then began to vomit. He then c/o feeling flushed, itching, headache, chest tightness, and SOB. V/S: B/P 126/82; pulse 103; resp 20; O2 sat 99% on RA; lungs clear upon asculatation; pupils equal and reactive; skin pink. Doctor was notified and assessed the employee 1455 - Doctor ordered Benadryl 50mg IM which was administered to the Left arm by nurse. 1505 - FSBS was 87; O2 sat was 98% on RA; pulse 97 1510 - O2 sat was 98% on RA; pulse 90 1520 - O2 sat was 98% on RA; pulse 98; employee was still vomiting; lungs remained clear 1528 - Employee reported that all symptoms were about the same, but waxing and waning; doctor ordered to give Zofran 4mg SL and this was given by nurse. 1530 - O2 sat was 98% on RA; pulse 90; B/P 122/90 1540 - O2 sat was 96% on RA; pulse was 88. Rechecked on Left hand - O2 sat was 98% on RA; pulse was 94 1545 - Employee reported improvement of headache, itching, chest tightness, flushing, and SOB; however, was still vomiting almost continously 1550 - O2 sat was 99% on RA; pulse 83 1600 - B/P - 118/84; pulse 78; resp 20; O2 sat 98% on RA; Employee still vomiting continously 1613 - Doctor recommended that the employee be evaluated in the ER. A family member/friend was called. Employee was taken to a private vehicle via wheelchair and transported to ER for evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,UNK,UNK,UNK,,UNK - Did not disclose any,"['Blood glucose normal', 'Chest discomfort', 'Dyspnoea', 'Flushing', 'Headache', 'Nausea', 'Pruritus', 'Vomiting']",1,PFIZER\BIONTECH,IM 920581,WA,55.0,F,"Injection site: appx 10 hours after the injection; pain, tenderness, swelling, redness and swelling(hardness). The tenderness and pain resolved on day 2 after the injection. The swelling(hardness) and redness was mostly resolved by day 4 after the injection. General side effects: headache. Chills and begin to feel feverish began appx 28 hours after the injection. This lasted appx 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Serevent,,Asthma,,,"['Chills', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Pyrexia']",1,MODERNA,SYR 920583,CT,60.0,F,hives at injection site followed by redness and swelling lasting 4 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,PUB,,,,,,"['Injection site erythema', 'Injection site swelling', 'Injection site urticaria']",1,MODERNA,IM 920584,FL,32.0,F,"After sitting 15 minutes I walked back to my department and my left forearm and hand was feeling pin pricks. I had numbness and tingling sensations for about 2 hours after the injection with no other symptoms. Did not need to seek medical attention. The next day I was severely fatigued and dehydrated. The arm with the injection was incredibly sore. All symptoms were gone day two after injection. One week after injection large raised, red bump appeared at injection sight. The spot was slightly sore an itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,PVT,Multi vitamin,,"alopecia areata, obesity",,,"['Dehydration', 'Fatigue', 'Hypoaesthesia', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Pain in extremity', 'Paraesthesia']",UNK,MODERNA,IM 920585,,24.0,M,"Fever 102.5, facial twitching, hypotension",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/20/2020,1.0,PVT,,none,none,,,"['Hypotension', 'Muscle twitching', 'Pyrexia']",1,PFIZER\BIONTECH,IM 920586,NY,56.0,F,"Rash 12/31 right upper chest, 01/01/21 chest abdomen, 01/02/21 same, 01/03/21 chest/abdomen/ bilateral anterior thigh 01/04/21 same / 01/05/21 - symptoms still present. Took Allegra daily, Benadryl 50 mg HS, 01/04/21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/31/2020,4.0,WRK,"Adderall 30 xr daily, Advair 250/50 daily, Krill oil 1 tab daily/ Vitamin D 1000 mcg daily, Calcium w/ zinc 3 tab daily",none,Asthma Adult ADHD,,"Almonds - hives Norco/Vicoden/hydrocodone - hives Morphine - SOB, hives",['Rash'],1,MODERNA,IM 920587,OK,46.0,M,"I has moderate pain in my left are starting in the afternoon of 12/31/2020. Then a few hours later I had body ache, joint pain, and I was very tired. I went to be early and when I woke up at 8AM on 01/01/2021 the symptoms were gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,UNK,,,,,,"['Arthralgia', 'Fatigue', 'Pain', 'Pain in extremity']",1,MODERNA,IM 920588,,28.0,F,"Arm pain, soreness and knot in arm- all began day after vaccine and lasted for about 4 days, treated with Ibuprofen and ice pack. Headache began day after vaccine, lasted for three days on and off- treated with Ibuprofen. Light headedness began on day 4 after vaccine, nothing helped, went away after 24 hours. Lymph node swelling occurred on day 5 after vaccine- in under arm and collar bone of the same side of body as injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,,,,,,"['Dizziness', 'Headache', 'Lymphadenopathy', 'Nodule', 'Pain in extremity']",1,MODERNA,IM 920590,NE,35.0,F,"Shortness of breath started on Wednesday afternoon. Right deltoid slightly swollen, no rash present at that time. Short of breath with no activity. Muscle aches, fatigue, just felt off. Then arm was very sore. Sunday night my arm pit really started hurting. Hurst over my shoulder, clavicle, and down into the lateral side of my breast. Bothered enough in the night that I didn't sleep well. This morning 1-5-21 I have a red rash over the injection site, arm is swollen over deltoid and hot. Arm pit and down into breast is still hurting significantly. I took Ibuprofen yesterday and helped some with pain in arm pit. Off an on SOB and chest feels tight. No cough",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/30/2020,2.0,PVT,"Zyrtec, B complex vitamin, Vit C, Zinc, Calcium, Vitamin D, Women's daily MVI, Buspar, Mircette","Bad headaches >4 months, sinuses, teeth hurting. A CT of head was negative, sinuses from dentist and CT scan normal,",None,,"Sulfa, Tetracycline, latex","['Arthralgia', 'Axillary pain', 'Bone pain', 'Breast pain', 'Chest discomfort', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Myalgia', 'Pain in extremity', 'Rash erythematous', 'Sleep disorder']",1,MODERNA, 920591,OH,56.0,F,"""severe dizziness"" When waking up and having to lay down throughout the day",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/04/2021,4.0,WRK,,,,,,['Dizziness'],1,MODERNA,IM 920592,TX,44.0,F,I recieved my vaccine on December 23rd and Exactly 7 days after receiving the vaccine my injection site began to itch and became red and swollen. It was also warm to touch. I took benadryl and applied cortisone cream to the site. I also started with nasal drainage and cough as well as fatigue and night sweats.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PVT,"Lisinopril-HCTZ, METFORMIN HCL, VITAMIN D2, ZYRTEC",None,"Hypertension, diabetes",,Sulfa,"['Cough', 'Fatigue', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Night sweats', 'SARS-CoV-2 test', 'Sinus operation']",1,MODERNA,IM 920593,IL,29.0,F,"Started with numbness to the whole body, palpitation, Dyspnea, and increased heart rate. This began 20 minutes after the injection. Lasted about 25 minutes. After this episode subsided, I continued to have persistent Dyspnea, chest pain, palpitations and heart racing. Was unable to speak in full sentences, exercise. Walking short distances caused extreme SOB. These symptoms lasted about a week.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,no,"no, Was COVID positive the last week of October",no,,no,"['Blood thyroid stimulating hormone', 'Chest X-ray', 'Chest pain', 'Dyspnoea', 'Dyspnoea exertional', 'Electrocardiogram', 'Fibrin D dimer', 'Full blood count', 'Heart rate increased', 'Hypoaesthesia', 'Metabolic function test', 'Palpitations', 'Troponin']",1,PFIZER\BIONTECH,IM 920594,CO,50.0,F,"Began with tingling down my right arm, and I became a little shaky. Drank some water and the shakiness continued to get worse. Went to the restroom and felt like I was going to pass out. Tingling came back across my upper body (chest level to shoulder level), I began to shake excessively, my mouth got very dry and my skin became splotchy. I was breathing hard like I had just ran flights of stairs. Nurses were called and I was given Benadryl and taken to the Emergency Room at a neighboring hospital where they hooked me up to I believe heart and BP monitors. My blood pressure was very high and my heart was pounding so hard. Was given steroid pills. All day I urinated excessively and my heart pounded hard.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PVT,Levothyroxine,None,Thyroid Disease,,Doxycycline,"['Dizziness', 'Dry mouth', 'Dyspnoea', 'Hypertension', 'Palpitations', 'Paraesthesia', 'Pollakiuria', 'Rash macular', 'Tremor']",UNK,MODERNA,IM 920595,CT,36.0,F,"12/23/2021 VACCINATION. ACHEY JOINTS, SORE AT INJECTION SITE, FEVER AND CHILLS AT 7PM. CONTACTED PCP TO SEE IF CAN TAKE IBUPROFREN. CALLED COVID HOTLINE AND THEY REFERRED ME TO CALL MY PCP. 12/24/20210INJECTION SITE SEVERE PAIN, COULDN'T MOVE ARM. 'FELT LIKE STABBING WITH A KNIFE', SOB, AND FEVER AND CHILLS 12/25/2020 COLD SYMPTOMS AND FEVER 12/26/ COLD SYMPTOMS, RUNNY NOSE, FEVER, FATIGUE 12/27/2020 FEVER, SOB, ACHY JOINTS; MILDER SYMPTOMS 12/28/2020 STARTED TO FEEL BETTER",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"BRIO, MONTALUCAS; CLARITAN, INHALER, CALCIUM VITAMIN",,ASTHMA,,PENICILLAN; LACTOSE INTOLERANT; ENVIRONMENTAL ALLERGIES,"['Arthralgia', 'Chills', 'Dyspnoea', 'Fatigue', 'Influenza virus test negative', 'Injection site pain', 'Mobility decreased', 'Nasopharyngitis', 'Pyrexia', 'Rhinorrhoea']",1,PFIZER\BIONTECH,SYR 920596,OH,63.0,F,"Muscle pain at injection site, fatigue, became very cold without chills, fever, headache, nausea, head fog",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,None,None,None,,Bactrim,"['Fatigue', 'Feeling abnormal', 'Feeling cold', 'Headache', 'Injection site pain', 'Nausea', 'Pyrexia']",1,MODERNA,SYR 920597,NE,64.0,F,"ON 12/31, DEVELOPED BODY ACHES, NAUSEA, SWOLLEN LYMPH NODES UNDER ARMS AND NECK. INJECTION SITE WAS VERY SORE. RESOLVED AFTER 48 HOURS.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,SEN,,,,,,"['Injection site pain', 'Lymphadenopathy', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,IM 920598,TX,55.0,M,"Later the same day after I received vax, Around 8-8:30 i had body aches. Noticed that when my arm is to the side of my body, it started going numb- right arm. I also had to get up around 4 times to urinate a lot. I was getting night sweats. When I would get up, I had a slight head ache and dizziness. I still have it right now, the headache and dizziness. Even when I walk, I have to extend my pinky finger out so my arm will not go numb. As we are speaking right now, my pinky finger is going numb. Once I extend it out, it goes away, but when I put it down by my side, it goes numb. My whole body is sore as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Atrovabstatin 20 mg, Clopidogrel 75mg",No,Stents in Heart.,,No,"['Dizziness', 'Gait disturbance', 'Headache', 'Hypoaesthesia', 'Night sweats', 'Pain', 'Pollakiuria']",UNK,MODERNA, 920599,WA,31.0,F,"sore arm (unable to lift without aching/hurting) for 2-3 days (improved each day, worst the day after vaccination) chills, low grade temp of 100.4F (went down with Tylenol), malaise, myalgia for one day starting the day after vaccination (Sunday evening and resolved by Monday morning)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/27/2020,1.0,PVT,Ibuprofen & Tylenol,None,None,,None,"['Chills', 'Malaise', 'Myalgia', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 920600,GA,47.0,F,Large bald spot on top of head!!! The size of a half dollar. No new soaps no no hair products no new medication. Nothing new.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/31/2020,30.0,PUB,"PROGESTERONE 100 MG, 1 PO DAILY PRPTONIX 40MG, 1 PO DAILY",none,PRE DM EPISCERITIS OF RIGHT EYE ACID REFLUX,,None,"['Alopecia', 'Biopsy', 'Laboratory test']",UNK,PFIZER\BIONTECH, 920601,KS,65.0,F,"9 to 10 days after administration I started with left shoulder and bicep pain. vaccine was given low in the arm and away from the joint so I did not get concerned at the beginning. The pain has progressed despite range of motion exercises, ibuprofen, heat and topical steroid cream. It has affected the use of my arm and I started myself on 30 mg of prednisone today with concern of SIRVA. I am unable to seek any medical care at this time as I am driving my husband for cancer treatment and won't be home until Saturday the 9th of January. I wanted to report these symptoms so if anyone else has similar symptoms it can be counted.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/31/2020,9.0,PVT,Avalide Lipitor trazodone zetia multivitamin vitamin D baby aspirin melatonin,none,asthma hypertension elevated lipids,,penicillin sulfa shellfish,"['Arthralgia', 'Mobility decreased', 'Myalgia', 'Product administered at inappropriate site']",1,PFIZER\BIONTECH,IM 920602,MA,33.0,F,"injection site reaction 15 minutes after dose, Itchiness, small red bumps. 3 days later red hard 2 in diameter bump at injection site. painful, itchy and red. symptoms resolved within 7 days of dose",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,"Vitamin C 1000mg qd, Sertraline 100mg qd, cetirazine 10mg qd, monolaurin 100mg qd, zinc 30mg qd,",,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Rash erythematous']",1,MODERNA,IM 920603,TX,50.0,F,5 MINUTES AFTER INJECTION FELT WARM ALL OVER. HEART RATE 99 BP 180/101. SENT TO ER. GIVEN BENADRYL AND DISCHARGED TO HOME STABLE. EMPLOYEE REPORTS HER HR INCREASED THAT NIGHT AND NEXT DAY FOR A FEW MINUTES AND THEN COMPLETELY RESOLVED BY THE THIRD DAY.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,bio identical hormones,no,no,,no,['Feeling hot'],1,PFIZER\BIONTECH,IM 920604,NY,73.0,M,Low grade fevers ranging from 100.7 to100.9 over two days. Lower grade fevers 99.4 - 99.7 day three Fatigue Intermittent diarrhea for one day Day four all was back to normal,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,,,Hypertension (Controlled) Obesity,,KNA,"['Diarrhoea', 'Fatigue', 'Pyrexia']",1,MODERNA,IM 920605,TX,47.0,F,"Approximately 20-25 min. post vaccination, employee reported chest tightness, flushing and light headed. She was alert and oriented x 3. V/S: 120/72; pulse 140; resp 22; O2 sat 99% on RA; pupils equal and reactive; skin pink. Dr was notified and assessed the employee. Dr. ordered Benadryl 25mg PO which was administered at 1050. 1120 - o2 sat was 98% on RA; pulse 85; employee reported that chest tightness resolved and light headedness impoved, but not resolved; she continued to be flushed. Symptoms continud to improve. Employee remained in the observation area and was instructed to seek emergency treatment if symptoms returned, worsen or new symptoms occured. She verbalized understanding.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,UNK,UNK,UNK,,UNK - Did not disclose,"['Chest discomfort', 'Dizziness', 'Flushing']",1,PFIZER\BIONTECH,IM 920606,NJ,57.0,F,"First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I also experienced headache, nausea, diarrhea and fever. I continue to have tingling in my face. I called employee health, and they told me to isolate. Because they were trying to rule out if it was COVID, but test was negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/20/2020,0.0,PVT,Losartan 25 mg,No,Hypertension,,No,"['Blood pressure abnormal', 'Diarrhoea', 'Headache', 'Impaired work ability', 'Nausea', 'Palpitations', 'Paraesthesia', 'Pyrexia', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH, 920608,VA,25.0,F,"Headaches began 24 hours after vaccination and are currently still persisting a week later. Pain and tenderness at injection site, as well as edema, erythema, and urticaria at injection site are currently persisting.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,WRK,"Victoza 1.8mg SQ daily, pantoprazole 40mg PO daily, women's multivitamin 2 gummies dialy, Benadryl 2mg PO nightly, Lexapro 20mg PO daily",none,"PCOS, metabolic syndrome, anxiety/depression, GERD",,"Seafood, sulfa drugs, penicillin, hydrogen peroxide, adhesive tape","['Headache', 'Injection site erythema', 'Injection site oedema', 'Injection site pain', 'Injection site urticaria']",1,MODERNA,IM 920623,OH,25.0,F,Rash at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,PVT,none,NONE,NONE,,NKDA,['Injection site rash'],1,MODERNA,IM 920625,FL,67.0,M,Lightheadedness and hot. Evaluated by onsite paramedic and doctor. Released by EMT and doctor continued to observe for 15 more minutes and then released home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PUB,,History of irregular heartbeat.,,,,"['Dizziness', 'Feeling hot']",1,PFIZER\BIONTECH,IM 920626,NJ,30.0,F,3.5 hrs following administration I experienced a near syncopal episode followed by vomiting.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,Migraines,,,"['Syncope', 'Vomiting']",1,MODERNA,IM 920627,ID,28.0,F,"Day of administration around 2100 I started feeling a little off, got a little bit of a headache and felt warm. While sleeping I could feel that I had chills and felt very warm. Woke up at about 0200 to take my temperature. Felt dizzy when I got up, still had a headache and a fever of 101.0 (taken orally). Contacted a nurse triage line to ensure I can take t=Tylenol to bring the fever down and get rid of the headache. She said yes, which is when I took 500mg Extra Strength Tylenol rapid release. Continued to feel not so well, and broke my fever around 0630 timeframe. Once I woke up around 0900 (day after administration) still felt a little warm (99.5) and a mild headache. Will keep an eye on any other adverse reactions.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PHM,"Estradiol 1mg, biotin vitamin and ritual mutli-vitamin",,,,No,"['Chills', 'Dizziness', 'Feeling abnormal', 'Feeling hot', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 920628,NY,63.0,F,"6-7 hours after the vaccine she developed arm pain, fever and chills. About an hour later she started to have abdominal pain which worsened over the course of the day to excruciating. She went to the Emergency Room where a CT scan revealed a perforation of her sigmoid colon and had a resection of the area of the colon and a diverting colostomy surgery done the evening of 1/3/2021.",Not Reported,,Yes,Yes,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,Tylenol 350 mg as needed Valium 5 mg as needed,,pancreatic cysts colonic polyps last colonoscopy 9/2020 and one polyp removed ATM gene mutation hyperlipidemia DCIS of breast in 1/2015 s/p lumpectomy and xrt thyroid nodules vertigo,,Compazine led to restless leg syndrome Penicillin anaphylaxis Sulfamethoxazole rash,"['Abdominal pain', 'Chills', 'Colostomy', 'Computerised tomogram abdomen', 'Computerised tomogram abnormal', 'Intestinal resection', 'Large intestine perforation', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 920629,WI,31.0,F,"Elevated heart rate-resolved quickly; flushing feeling; potential throat swelling (felt like lump in throat), no airway compromise.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Prenatal vitamin, NuvaRing",None,"Asthma: exercise-induced, rare; heart palpitations.",,NKDA,"['Heart rate increased', 'Hot flush', 'Pharyngeal swelling', 'Sensation of foreign body']",1,MODERNA,IM 920630,GA,44.0,F,From the shot I felt a sore arm for a couple of days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,PUB,Prozac,I had an headache a couple days prior to the shot.,Depression and hypertension,,None,['Pain in extremity'],1,MODERNA,IM 920631,,45.0,F,Redness and itchy at insertion site.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,01/01/2021,6.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 920632,OH,35.0,F,"Injection site reaction, rash and pain",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/04/2021,12.0,PVT,Anitbiotics,None,None,,NKDA,"['Injection site pain', 'Injection site rash', 'Injection site reaction']",1,MODERNA,IM 920633,WI,43.0,F,"Dizzy, lightheaded, extreme tingling in arms and hands, tingling in the face, numb tongue, heart palpitations, feeling faint, blurred vision, shaking",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,probiotic,no,ehlers danlos syndrome hypermobility type,,Yeast allergy,"['Dizziness', 'Hypoaesthesia oral', 'Palpitations', 'Paraesthesia', 'Tremor', 'Vision blurred']",1,MODERNA, 920634,GA,58.0,F,"The day that she received her vaccine, she had a dime-sized red raised area, but denies any other complaints. Last night, (12 days after vaccine) EE noticed the area where she received her vaccine had a large raised red, warm, itchy, and ""hard"" circular area. She outlined the area last night, and today, the area of redness is 1-2cm outside of the outline. Left arm rash, deltoid area, 7.5-8cm, warm, red, firm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,"Levothyroxine, atorvastatin, fluoxetine, omeprazole.",None,"Hypothyroidism, HLD, anxiety/depression, GERD, obesity",,PCN,"['Injection site erythema', 'Injection site nodule', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 920635,WA,28.0,F,"Exactly a week later, I noticed I had a 2 inch lump underneath my chin where my lymph node, it was tender to the touch. on 1/5th, I can still feel the lump, but is not longer tender to the touch. I also developed blisters ( almost like herpes like) on the R side of my nose and on the inside of my nose. I never had blisters in my life, or herpes like blisters on my face. Now on 1/5/21, the blisters are starting to dry, but are still there. I as ask to contact you guys to see if I can get my second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,WRK,none,none,none,,none,"['Blister', 'Lymph node pain']",1,PFIZER\BIONTECH,IM 920636,,29.0,F,Muscle soreness at the injection site. Significant for 2 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/18/2020,1.0,MIL,,,,,,['Injection site pain'],UNK,PFIZER\BIONTECH, 920637,IL,46.0,F,"Body ache, chills, sweating, fever, and Headache",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,SEN,"multivitamin, vitamin C and D3",,HTN,,NKA,"['Chills', 'Headache', 'Hyperhidrosis', 'Pain', 'Pyrexia']",1,MODERNA,IM 920638,CA,51.0,F,"Sore Arm Achy, felt like flu was coming on nausea headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,,,,,,"['Headache', 'Influenza like illness', 'Nausea', 'Pain in extremity']",1,MODERNA,SYR 920639,MS,40.0,F,Slight redness and soreness at injection site. The wrist of the injection arm is swollen at the joint to roughly double that of the opposite arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PUB,None,None,None,,None,"['Injection site erythema', 'Injection site pain', 'Oedema peripheral']",1,MODERNA,IM 920640,MA,52.0,F,"Patient received COVID vaccine (RD) at 0846, shortly after (less than 1 min) patient reports ""warmness and tingling"" radiating from right arm to right side of abdomen. No VS recorded, patient denied offer to take vitals. Patient sat with this RN fort 1 minute longer for observation, stated she could walk herself to observation area.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,Macrolides antibiotics,"['Feeling hot', 'Immediate post-injection reaction', 'Paraesthesia']",1,MODERNA,IM 920641,,62.0,F,"By 1400 had low grade HA, by 1600 more severe. Managed with Tylenol. 1800 no appetite, and nauseated. Continued through night.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Decreased appetite', 'Headache', 'Nausea']",UNK,PFIZER\BIONTECH, 920642,CA,43.0,F,"Pt. received on injection 12/28/20. They are experiencing a delayed reaction at the injection site. On Sunday 1/3, pt. had slight itching at the site. 1/4, the itching was worse & pt had some warmth/redness/swelling at the site (approx 3 cm in diameter) . Pt took 25 mg benadryl & 800 mg motrin when they got home from work at about 2 am on 1/5. Pt also used OTC hydrocortisone w/no relief. The site remains very itchy & warm to touch. There is slight redness & the area is now about 4-5 cm in diameter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Condition aggravated', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 920643,CA,40.0,F,Localized rash (hives) at injection site on DAY 8 after vaccination. 3x6cm around injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/04/2021,8.0,PVT,"estradiol patch, Kyleena IUD",none,none,,none,"['Injection site rash', 'Injection site urticaria']",1,MODERNA,IM 920644,TX,41.0,F,"At around 0910, employee reported tingling on tongue and roof of mouth while in the monitoring area post vaccination. RN obtained V/S: 122/76; pulse 78; resp 18; pupils equal and reactive; skin pink. Employee was alert and oriented. She reported slight reaction about 30min. post vaccination. Dr. was notified and assess the employee. Dr. ordered Benadryl 25mg PO at 1001. This was administered by RN. Employee was monitored for another 20 minutes and then was aloud to leave. Employee was feeling better before leaving. She was instructed to seek medical attention if symptoms returned or new symptoms occured. She verbalized understanding.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,UNK,UNK,UNK,,UNK,['Paraesthesia oral'],1,PFIZER\BIONTECH,IM 920645,AR,47.0,M,"Patient tested positive for COVID-19 via rapid Antigen test on 1/5/21. Patient has a child who tested positive on 1/3/21. Patient woke up on Sunday 1/3/21 feeling sick -- fatigue. Progressively, patient developed more symptoms: fever, cough, congestion, headache, chills, rigors. Patient is not sick enough at this time to go to doctor or hospital. Patient will quarantine for 10 days at home.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/03/2021,3.0,PHM,daily Multivitamin,none,none,,oral terbinafine - causes rash,"['Chills', 'Cough', 'Fatigue', 'Headache', 'Malaise', 'Nasal congestion', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 920646,NM,30.0,F,"Severe nausea, vomiting, dehydration requiring IV hydration and antiemetics",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PUB,None,None,None,,None,"['Dehydration', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 920647,IL,21.0,F,"Insomnia, fever, tenderness in the injection site, chills,",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Injection site pain', 'Insomnia', 'Pyrexia']",1,MODERNA,IM 920648,NC,51.0,F,Swelling and soreness in armpit of right arm . First observed last evening and still evident this A.M.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/04/2021,9.0,PVT,Dupixent 300mg OTC. Aller-Tec (Kirkland) Vitamin D3 Vitamin B complex Luteal & Zeaxanthin,None,None,,,"['Axillary pain', 'Swelling']",1,MODERNA,IM 920649,MI,32.0,F,"Fever >100, body aches, chills, injection site inflammation,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,"Lexapro, multi vitamin, collagen",N/a,Anemia,,Amoxicillin,"['Chills', 'Injection site inflammation', 'Pain', 'Pyrexia']",1,MODERNA,IM 920650,IA,49.0,F,"ON 1/1/21, DEVELOPED SWELLING ON UNDERSIDE OF LEFT ARM. DISCOMFORT IN THE AREA AND PAIN RADIATING TO HER LEFT BREAST. ON 1/4/21, STATES THAT THE SWELLING IS RESOLVED AND THE PAIN IS IMPROVING, BUT STILL PRESENT IN THE LEFT BREAST.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,SEN,,,,,,"['Breast pain', 'Pain', 'Pain in extremity', 'Peripheral swelling']",1,PFIZER\BIONTECH,IM 920652,,53.0,F,"Pt reported thickness is throat and tingling in tongue. Vital signs remained stable for 30 minutes. BP 129/59, HR 72, RR 20, 94-97% O2 on room air. 25mg PO Benedryl administered. Pt tolerated and reported feeling better prior to leaving clinic. Patient advised to go to ED or Employee Health if any other symptoms occur.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,WRK,,,,rash after a small pox vaccine,,"['Paraesthesia oral', 'Throat tightness']",1,MODERNA,IM 920654,TN,48.0,F,"After the initial dose of Benadryl wore off, my skin began to itch, as well as my throat and ears. My arm also swelled up to the size of a softball where the injection was. I developed some bumps on my body, but was not covered in a rash. I had no problems breathing. I was itchy all day Sunday and my arm seemed to go down a little, but on Monday, when I went to work and couldn't take the allergy meds, it swelled again to nearly the size of a baseball. I think I might be allergic to the acetic acid in it because that's part of the compound in Aspirin, but I'm not sure. It's Tuesday and I still feel yucky, my arm is still itchy and it's still feverish and swollen and red at the injection site. Please call me and let me know if I should take the second dose. My husband has heart failure and I am a teacher. I want to protect him, but I worry that I had that kind of reaction even after taking allergy medication just in case beforehand.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PUB,"I took two Benadryl in case I had an allergic reaction because I have a history of allergic reactions to penicillin (a rash all over my body), bees ( anaphylaxis and swelling) and aspirin (huge hives and swelling of lips and tongue) before",None,Asthma,,"bees, hornets, wasps cayenne pepper Aspirin (ASA) Penicillin","['Injection site erythema', 'Injection site swelling', 'Pruritus', 'Pyrexia', 'Rash', 'Throat irritation']",1,MODERNA,IM 920655,IL,23.0,F,"I had awful migraines that did NOT improve with Tylenol or Ibprophen. My migraines had an aura to them on the 1/1/2021. I was also nauseous and had a difficult time keeping food down. I was also very tired and slept longer than I normally do. I had my vaccine done on 12/30/2020 and the symptoms did not occur until 1/01/2021. An hour or so after the injection, my arm started to become sore. It was very sore until 1/3/2021. They lasted until 1/3/2021. Now I feel fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PUB,A woman's probiotic and one a day vitamins,,Migraines,,,"['Fatigue', 'Migraine with aura', 'Nausea', 'Pain in extremity']",UNK,MODERNA,IM 920657,MI,47.0,F,"high heart rate, blotchy/flushed skin, urticaria",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,NONE,MITRAL VALVE PROLAPSE,,NONE,"['Flushing', 'Heart rate increased', 'Rash macular', 'Urticaria']",1,PFIZER\BIONTECH,IM 920658,TX,44.0,F,"dizziness and stated ""feeling heart palpitations or PVC's"" . stated she had a history of PVC's before and had an ablation in 2012.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,MULTI VITAMINS METOPROLOL 25MG 1/2 TAB PO,,TETRALOGY OF FALLOT HEART ABLATION 2012 HISTORY OF PVC'S,,PERCOCET,"['Dizziness', 'Electrocardiogram', 'Laboratory test', 'Palpitations', 'Ventricular extrasystoles']",1,MODERNA,IM 920659,,52.0,M,"About 24 hours after vaccination, patient reported fever, chills, and body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,,,,,,"['Chills', 'Pain', 'Pyrexia']",1,MODERNA,IM 920661,FL,66.0,F,Moderna COVID - 19 Vaccine EUA,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,Synthroid .75 mg daily Ezetimibe 10 mg Vitamin C Vitamin D3 Folic Acid Vitamin B12 Fiber,,Fibromyalgia osteo arthritis Hypercholesterolemia Hypo thyroid B12 deficiency,,,['Unevaluable event'],1,MODERNA,IM 920662,OH,39.0,F,later on the day in the evening i got my shot my arm turn redness around the site of the injection and iched still redness and ichy the next day local reaction redness ichy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,none,none,diabetic high cholesterol,,lisinopril,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,SYR 920663,FL,70.0,M,Swelling under nose and under the lower lip along with redness. Client released home after evaluation by onsite paramedic and physician at 3:43 pm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PUB,,,,,,"['Erythema', 'Swelling face']",1,PFIZER\BIONTECH,IM 920664,IL,29.0,F,"Chills, Fever, Body ache, Headache, No appetite",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,SEN,Multivitamins,,,,MKA,"['Chills', 'Decreased appetite', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 920666,IL,21.0,F,"Insomnia, fever, chills, tenderness in injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,,,,,,"['Chills', 'Injection site pain', 'Insomnia', 'Pyrexia']",1,MODERNA,IM 920667,KS,22.0,F,"Fever, Body Aches, Headache, chills and nausea started at 10pm on 1/4/2021. Patient was seen in office on 1/5/2020. Patient was sent home to rest and advised to take tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Certirizine, Fluticasone, Zofran","Sneezing, itchy throat and congestion in December","Seasonal allergies, Chronic Fatigue",,"Shellfish, Oxycodone","['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,MODERNA,IM 920668,CA,51.0,F,Itchy Red Mark around the injection site tender to the touch,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,UNK,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,SYR 920669,IL,40.0,F,"Headache, Chills, Body Ache, Nasal congestion, Swollen injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,Albuterol,None,Asthma,,None,"['Chills', 'Headache', 'Injection site swelling', 'Nasal congestion', 'Pain']",1,MODERNA,IM 920670,FL,26.0,F,"Site pain and swelling for 6 days after vaccination. Day 7 post vaccination; redness, itching, edema at injection site, circular area, about 5 inches in diameter. Plus swollen, painful axillary lymph nodes bilaterally.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site oedema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA, 920672,TX,60.0,F,"Employee received the vaccine around 1130. She was monitored for a least 30 minutes due to her history of CA and Immunosupressed state. She went back to her office post monitoring. Around 1535, one of her employees called reporting that she didn't look good and was acting weird - pale; stumbling; slurred speech. The coworker brought employee to the immunization clinic in private vehicle. Dr. along with the CNE and another RN went to the vehicle to asses. It was noted that employee did have slurred/slow speech; droopiness to face. She reported that she started to not feel well while in her office. V/S: B/P 141/102; pulse 108; O2 sat 96% on RA; skin pale. She stated that she felt ""loopy"". Employees husband was called and her co-worker was instructed to take the employee to the ER where her husband would meet them. At 1540, employee was taken to ER for evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,UNK,UNK,Hx. of Cancer and Immunosuppressed disorders,,UNK,"['Abnormal behaviour', 'Dysarthria', 'Facial paralysis', 'Gait disturbance', 'General physical condition abnormal', 'Pallor', 'Slow speech']",1,PFIZER\BIONTECH,IM 920673,GA,37.0,F,"I received the Moderna COVID vaccine on 12/29. 12 hours after the vaccine I had numbness and tingling in my feet. The following morning (24 hours post vaccine) I still was having numbness and tingling in my feet and my legs from knees down felt weak and jelly like. I still was able to walk fine, but it was uncomfortable, not able to work out etc. 12/31 (48 hours post) I worked for 10 hours this day and symptoms were the same, that evening I continued to have same symptoms and my knees and ankles ached intermittently. 1/1- Same symptoms as previous days. 1/2- Same symptoms and started having tingling down back of upper leg from butt to back of knee, still tingling in feet. 1/2- Went to ER waited 8 hours and left. 1/3- Went to ER and they ruled out Guillain Barre Syndrome (did complete neuro exam) and said they have not seen this particular reaction to the vaccine but due to presentation they believe it is a vaccine reaction. No treatment prescribed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,WRK,,None,,,,"['Blood electrolytes normal', 'Blood magnesium normal', 'Blood phosphorus normal', 'C-reactive protein normal', 'Electrocardiogram normal', 'Exercise tolerance decreased', 'Full blood count normal', 'Hypoaesthesia', 'Limb discomfort', 'Muscular weakness', 'Neurological examination normal', 'Paraesthesia']",1,MODERNA,IM 920674,FL,27.0,M,Swollen lymph node under left armpit for four days starting 01.01.2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PVT,None,None,None,,None,['Lymphadenopathy'],1,MODERNA,IM 920675,NY,40.0,F,"Fever, body aches, chills and sweats",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,cough,,,,"['Chills', 'Hyperhidrosis', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 920676,CA,46.0,F,"Tachycardia started after 12 minutes, observed for 45 minutes. Symptom resolved over this period of time",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,None,None,None,,None,['Tachycardia'],1,MODERNA,IM 920677,MA,38.0,M,Patient experienced minor burning on administration to Left Deltoid. Moderna COVID vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,,,,['Injection site pain'],1,MODERNA,IM 920678,AZ,28.0,F,"Injection area mid upper arm. Edema to injection area , discoloration, 2 inch circular demarcation, pain to local area, itchiness numbness and tingling to left hand during first 7 days. Day 8 hard mass at injection site, rash, discoloration still present. Itchiness still present. PO benadryl taken, topical benadryl applied when PO not taken. Minimal relief from benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,UNK,"Topamax, Fluxotine,",No illness prior to or on vaccination date,"Diabetes, asthma",,No known allergies to date,"['Hypoaesthesia', 'Injection site discolouration', 'Injection site mass', 'Injection site oedema', 'Injection site rash', 'Pain in extremity', 'Paraesthesia', 'Pruritus']",UNK,MODERNA,IM 920679,NY,41.0,F,Patient reported having a swollen epiglottis on the date of the vaccination that did not resolve until the following date.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,,,No Known Allergies,['Pharyngeal swelling'],1,PFIZER\BIONTECH,IM 920680,IL,39.0,F,"I took the ""Moderna COVID-19 Vaccine EUA"" on December 31, 2020. I had pain/soreness at the injection site for 3 days, but I still have other side effects since getting the vaccine. The side effects started out with mild muscle pain and joint pain on the 31st, then in the night and for every day since the vaccine I have had headaches which I am taking ibuprofen for. I also feel quite fatigued since getting the injection. In the last few days I also had cold sweats, and chills yesterday. Today, I still have headache and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,Ibuprofen,None,Occasional palpitations,,None,"['Arthralgia', 'Chills', 'Cold sweat', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia']",UNK,MODERNA,IM 920681,RI,46.0,F,"Modern a COVID-19 Vaccine EUA I was given the injection last Monday and noted erythema itchiness and swelling to the site and I figured I?d keep an eye on it. Also I had been enrolled in the v-safe with the CDC so I felt if there was ever a red flag, that they would be aware. After about 2 days it seemed better but then on 1/4/2021 I noticed it was itchy again and I saw that I had a couple of blisters but they did go away after a hour. I now have the erythema, itchiness and a very hard (bigger than a half dollar) area surrounding the injection site. Today is day two of having this and no swelling noted in my axilla or lymph nodes. No fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/30/2020,2.0,WRK,"Vitamin D, Tumeric, Magnesium, Prozac, prn Motrin & Tylenol",None,Depression,,"Sulfa, Augmentin, Keflex","['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site vesicles']",1,MODERNA,IM 920682,TX,47.0,F,With in 2 minutes of shot felt: 1. Medicine being diffused out of heart with burning sensation that lasted about 30sec that followed by 2. Irregular heartbeat (that lasted about 5 minutes) 3.Need to get fresh air (felt like lowering mask) 4. Low blood pressure that caused little sweaty and cold hands All the symptoms in total lasted for 5 minutes and then I felt back to normal,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,None,None,None,much milder reaction to a local anesthesia during a dentist visit. About 2 years ago. That reaction causes irregular heartbeat a,"Recently noticed allergic to IV or intramuscular shots that leads to irregular heartbeat, low blood pressure","['Burning sensation', 'Heart rate irregular', 'Hyperhidrosis', 'Hypotension', 'Peripheral coldness', 'Sensory disturbance']",1,MODERNA,IM 920683,MI,54.0,F,"Started to feel dizzy about 9 hours after the injection. Went to bed. Woke up 8 hours later with an extreme headache 9/10 and nausea. Took 325 Tylenol and brought the pain down to a 7/10. Slept for a couple of hours and woke up with a headache at a 7/10 - took 650 mg Tyleno, drank some Focus Aid and ate some veggie straws. After about 1/2 hour the headache was down to a 4/10,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,"Multivitamin, Vitamin D",none,none,,PCN,"['Dizziness', 'Headache', 'Nausea']",1,PFIZER\BIONTECH,IM 920684,GA,53.0,M,NONE,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/30/2020,9.0,PVT,AZITHROMYCIN 250MG TABLET DEXAMETHASONE 4 MG TABLET FAMOTIDINE 40 MG TABLET METROPRLOL SUCC Er 100 MG TABLET MONTELUKAST SOD 10 MG TABLET PANTOPROZOLE SOD DR 40 MG TABLET ROSUVASTATIN CALCIUM 20 MG TAB VITAMIN D2 1.25MG,NONE,"HEART DISEASE, HEART ATTACK",,NONE,"['SARS-CoV-2 test positive', 'Unevaluable event']",1,PFIZER\BIONTECH,IM 920685,NY,51.0,M,"Fever 100.2, chills, headache and body ache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Rosuvastatin (Crestor) Amlodopine Besylate,None,Dystonia/Torticollis; Right hip bone marrow edema of undetermined cause.,,Penicillin,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 920686,NY,40.0,F,"Patient states - she initially had headache, L arm swelling and pain and it went away by day 5. Then the site swelled again and is now red, itching and has minor pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/04/2020,,WRK,Selenium Famotidine Combivent Multivitamin Vitamin C Vitamin B12,None,None,,Bactrim,"['Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 920687,WI,43.0,F,"localized erythema, warmth, swelling at injection location. itchy. tender to palpation",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,turmeric and curcumin ashwaganda green tea extract vitamin D trazodone hydroxyzine,no,GERD,,no,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA,IM 920688,VA,53.0,F,Tingling lips Sore throat Burning in chest Rash Headache Neck stiffness SOB,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,SEN,Benadryl Ibuprofen Vitamin D Melatonin,None,Arthritis Migraine headaches,Flu,Erythromycin Iodine Shell fish/fish Morphine Augmentin Strawberries,"['Chest pain', 'Dyspnoea', 'Headache', 'Musculoskeletal stiffness', 'Oropharyngeal pain', 'Paraesthesia oral', 'Rash']",1,PFIZER\BIONTECH,IM 920689,OK,43.0,M,"Client started c/o headache, tightness in chest, and was anxious. He was helped out of his truck and taken to triage where they administer o2 4Liters via nasal cannula. He self administered his albuterol inhaler. He admits to having anxiety issues. He was monitored for 20 mins and no other problems arose and he felt better after that. He has had no other problems related to the vaccine since that occasion. He did not contact his doctor.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,"generic Zoloft, trazadone, albuterol inhaler",bronchitis and asthma problems one month prior to vaccine,asthma,,wasp venom,"['Anxiety', 'Chest discomfort', 'Headache']",1,PFIZER\BIONTECH,IM 920690,PA,30.0,F,Severe Headache; Light sensitivity; Nausea; Bilateral upper extremity tingling,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Headache', 'Nausea', 'Paraesthesia', 'Photophobia']",UNK,MODERNA,IM 920691,CA,36.0,F,Fever Body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,,,,,,"['Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 920692,IL,59.0,F,"Chills, head ache, Body ache, fever, leg pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,Tylenol,"Patient was sick in November with fever, chills and fatigue. Testx2 for COVID negative both times.",Back pain,,Zithromax and Diflucan,"['Chills', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 920693,IA,40.0,M,"Arm soreness for 3 days following injection Fatigue day after injection Sore throat, feels like swollen tonsils began 2 days after injection and continues today Visible sore under tongue began 2 days after injection and continues today",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,WRK,"Lisinopril, Flonase, Zyrtec, multi-vitamin",Sinus infection prior,"Hypertension, multi-nodule goiter, muscular dystrophy",,"Sulfa, environmental allergies","['Fatigue', 'Oropharyngeal pain', 'Pain in extremity', 'Tongue ulceration', 'Tonsillar hypertrophy']",1,MODERNA,IM 920694,TX,43.0,F,I had lymphadenopathy in my right armpit for three days post vaccine. I used a heating pad to treat. I also developed swelling on my right forearm that was hot to touch with pain. I used a heating pad as well on my right forearm and took Tylenol for two days-it resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,PVT,Flonase; Symbicort,None,asthma,,None,"['Lymphadenopathy', 'Peripheral swelling', 'Skin warm']",1,PFIZER\BIONTECH,IM 920695,CO,53.0,F,"headache, low grade fever, body aches, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"mobic, levothyroxine",,"arthritis, hypothyroid",,,"['Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 920696,NY,50.0,F,"9cm by 9cm area left deltoid; raised, hot to touch, pruritic topical steroids mupirocin to minor excoriations from itching zyrtec 10 mg qd benadryl prn cool compresses",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,Proventil Hfa/ Marlissa 0.15-30 mg-mcg oral tablet/ Flonase/ zyrtec allergy 10 mg oral tablets/ Flovent hfa 44mcg/ Estrace 0.1mg/ gm/ vaginalcream/ buproion xl 300mg tabs/ mupirocin/ hydrocrtisone 2.5 %/ protopic 0.1% external ointment/,None known,Asthma depression frequent uti's 11/21/19 - Solid lung nodules measuring up to 4 mm without significant change.,,Ibuprofen macrobid apples pineapple,"['Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pruritus', 'Skin abrasion']",1,MODERNA,IM 920697,IL,64.0,F,FEVER,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,NONE,NONE,HTN,,NONE,['Pyrexia'],1,MODERNA,IM 920698,ME,50.0,F,Burning/ tingling tongue,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/23/2020,2.0,OTH,No,No,"Hemochromatosis, migraines",,Erythromycin,"['Paraesthesia oral', 'Tongue discomfort']",1,PFIZER\BIONTECH,SYR 920700,CA,29.0,F,Patient felt pain and heaviness to right back side of head/neck area and reported dizziness. Patient states she has a history of vertigo and gets dizzy easily.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,unknown,unknown,unknown,,NKDA,"['Dizziness', 'Headache', 'Neck pain']",1,MODERNA,IM 920701,IL,27.0,F,"12/18/20- reports suddenly got sweaty, hands felt cold, then got nauseous. Reports vomitted x 1. Reports the rest of the day felt tachycardiac for a few hours (HR 120-140) and dizzy. Started getting muscle aches/joint aches. Denies any recent COVID exposure. Tested positive for COVID In 8/2020. Reports hips/knees are throbbing today; Heart rate WNL. /// Presenting today due to intermittent presyncope and palpitations. Also notes generalized weakness. Patient evaluate 2 L of fluid given her Mirena IUD D-dimer was sent which was negative patient with no pleuritic symptoms or dyspnea to suggest pulmonary embolism. Otherwise hemodynamically stable on exam ambulates with no difficulty no focal neurologic deficits. Patient did describe on her initial presentation that she noted some weakness of her bilateral legs. Given her possible viral reaction and description of weakness it is possible the patient is developing an early autoimmune reaction however she has no evidence of GuillainBarr� or transverse myelitis on my exam. We will plan to discharge with neurology follow-up as outpatient.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/18/2020,1.0,UNK,,,,,,"['Arthralgia', 'Asthenia', 'Chest X-ray normal', 'Dizziness', 'Electrocardiogram abnormal', 'Full blood count', 'Hyperhidrosis', 'Laboratory test', 'Muscular weakness', 'Myalgia', 'Nausea', 'Pain', 'Palpitations', 'Peripheral coldness', 'Presyncope', 'Tachycardia', 'Urine analysis', 'Vomiting']",1,PFIZER\BIONTECH,IM 920702,IL,38.0,F,"Fever, chills, Headache, Body Malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,none,,None,,NKA,"['Chills', 'Headache', 'Malaise', 'Pyrexia']",1,MODERNA,IM 920703,TX,69.0,M,"Mild pain at injection site increased to moderate/moderately severe requiring two doses of acetaminophen 825 mg p.o. Pain reached a maximum at around 9 pm on 1/4/21. Malaise, body aches, skin sensitivity also increased during the day on 1/4, relieved somewhat by the Tylenol. I was never able to document fever though I felt ""feverish"". Awoke on 1/5/21 feeling better and all symptoms are steadily improving though not completely resolved at time of this report, 1045 hours on 1/5/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,PUB,Sotalol 80 mg bid Eliquis 5 mg bid Allopurinol 100 mg q day Simvastatin 20 mg q evening at bedtime Culturelle 1 capsule each day Multivitamin Centrum Silver,None,"Chronic kidney disease Stage 3 Status post aortic valve replacement October, 2018","Shingrix vaccine both first and second injections 6/15/19 and 9/6/19. Fever, chills, body aches, arthralgias. Age 68.",Penicillin drugs,"['Hyperaesthesia', 'Injection site pain', 'Malaise', 'Pain', 'Pyrexia']",1,MODERNA,IM 920704,PA,45.0,F,"Moderna COVID-19 Vaccine EUA 7 small itchy marks/ bumps on left wrist progressively worsening to swelling, warmth surrounding left wrist (day 6). 2 red marks above left clavicle and 1 red mark on right eyelid (day 5).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,none,none,none,,none,"['Erythema', 'Erythema of eyelid', 'Joint swelling', 'Rash', 'Rash pruritic', 'Skin warm']",1,MODERNA,IM 920705,TN,35.0,F,"Fever, joint pain, body aches, fatigue, tingling in spine, headache, nausea, vomiting, tightening in chest when mobile, Symptoms lasted approx. 48 hours. Treatment- rest, fluids, inhaler, ibuprofen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PUB,"Probiotic, multivitamin, Vitamin D, Apple cider vinegar gummies",Sinus infection and ear infection one month prior,Asthma,,"Biaxin, Amoxicillin, Mango,","['Arthralgia', 'Chest discomfort', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Paraesthesia', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting']",1,MODERNA,IM 920706,CA,33.0,F,"Day 1 - Injection given around 8:30am - developed fever and headache around 2pm, muscle aches and fatigue started shortly after. Fever (101) broke around midnight. Day 2 - Headache lasted until 1pm (I took two OTC Tylenol at 10am), Entire body was extremely sore and I felt very exhausted. Day 3 - Felt almost back to normal. Day 7 - Injection site is still red, swollen, and hard. On my neck there are lumps that just appeared and cause some discomfort. Fatigue is still there. On another note I have found it difficult to catch my breath at times this past week.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,"Metformin 1000mg, Cranberry with probiotic",Diabetic,Diabetic,,,"['Dyspnoea', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Musculoskeletal discomfort', 'Myalgia', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 920707,OH,40.0,F,"I took the Moderna Covid vaccine on 12-28-2020 at 1420. After getting the shot, I had a metallic taste in my mouth and drank some water then waited 20 mins. When I left to go back to my department, I started getting dizzy and coughing. I sat down in my department and could not stop coughing so I went to the ER department. My eyes were swollen, I had a rash from my arms and legs all the way down my body. I had hives on my face and my eyes were swollen. I was coughing and wheezing. the ER RN started an IV and I was given steroids, diphenhydramine, ondansetron and IV fluids. I was also given some cough medicine. I was monitored for a few hours and before I left - they gave me hydroxyzine for the hives and itching. The PA also ordered meds for me to take at home. - per patient report",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,no,,"influenza (hives, rash, vomiting)","influenza vaccine (rash, hives, vomit)","['Cough', 'Dizziness', 'Dysgeusia', 'Eye swelling', 'Pruritus', 'Rash', 'Urticaria', 'Wheezing']",UNK,MODERNA,IM 920708,GA,45.0,M,"headache, nausea,nasal congestion, dizziness, Symptoms resolved in 48 hrs , took Tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/20/2020,2.0,PVT,none,none,none,,none,"['Dizziness', 'Headache', 'Nasal congestion', 'Nausea']",1,PFIZER\BIONTECH,IM 920709,MN,49.0,F,9 days later had large red mark raised and bump at vaccine site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/01/2021,9.0,PVT,Vitamin D Multi-vitamin,none,none,,Seasonal Bee Venom,"['Injection site erythema', 'Injection site swelling']",1,PFIZER\BIONTECH,SYR 920710,IL,59.0,F,"Fatigue, sinus pain, nausea , vomiting , Chills, Body Aches, Fever. Headache, Diarrhea, runny nose Tenderness at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,Preservision Vitamin D. Fish oil,None,Glaucoma,"Shingrix Shingles Vaccination - Fever chills, fatigue",sulfa,"['Blood count abnormal', 'Chest X-ray abnormal', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia', 'Rhinorrhoea', 'Sinus pain', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 920711,UT,31.0,M,"I am the patient's neurologist. The patient has very well controlled epilepsy without a seizure in over a year. He is compliant with medication and did not have another provoking factor. Approximately 6 hours after receiving the vaccine he had a generalized seizure, which was witnessed by his wife. He had an aura, behavioral arrest, tonic-clonic activity for 1 minute followed by a post-ictal period of several hours. This is consistent with his known seizures, but the provocation appears to be the vaccine he received earlier in the day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,Lamictal,"Cholelithiasis, 12/09/2020",Epilepsy,,No known allergies,"['Abnormal behaviour', 'Aura', 'Postictal state', 'Seizure', 'Tonic clonic movements']",1,MODERNA,SYR 920712,IL,24.0,F,"Body malaise, Sore to injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,NONE,NONE,NONE,,NONE,"['Injection site pain', 'Malaise']",1,MODERNA,IM 920713,WV,56.0,F,Deep muscle soreness developed within 2 hours. Soreness restricted movement prevented normal activities and work for 12 hours. Temperature 99 at 12 hours following injection. Insomnia 12/15. Fatigue x 2 days. No redness or swelling at injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/15/2020,12/15/2020,0.0,PUB,None,None,"Hypothyroidism, Migraines",,None,"['Fatigue', 'Insomnia', 'Loss of personal independence in daily activities', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 920714,FL,73.0,F,Client experience dizziness. Client was evaluated by onsite paramedic and released to ho home at 9:57 am.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,unknown,unknown,"Heart disease, Diabetes (control)",,sulfa,['Dizziness'],1,PFIZER\BIONTECH,IM 920715,MD,49.0,U,"15:30 complete, injection site warmth. VS: T97.5, HR 108, 95% SpO2, BP 162/72. Patient monitored for 10 more minutes, doctor notified. Patient cleared. Second set of vitals obtain: HR 113, BP 139.67, 100% SpO2.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/23/2020,0.0,UNK,Unknown.,Unknown.,Unknown.,,No known allergies.,"['Heart rate increased', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 920716,TN,45.0,M,"Received vaccine on 12/21/2020. Developed constipation that cleared on 12/26/2020 with use of colace. Had episode of diarrhea on 12/28/2020. Abdominal pain began at 2330 on 12/29/2020 and worsened through the night. Went to ER at 0500 hours on 12/30/2020 where I was diagnosed with appendicitis and underwent appendectomy on the same day by Dr. I have no idea if this is related to the vaccine or simply a coincidence. In error of caution, I am reporting this. Thank you.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/29/2020,8.0,PVT,"Olmesartan, HCTZ, amlodipine, collace",Episode of constipation 3 days earlier.,"OSA, HTN",,None,"['Abdominal pain', 'Appendicectomy', 'Appendicitis', 'Computerised tomogram', 'Condition aggravated', 'Diarrhoea']",1,PFIZER\BIONTECH,IM 920717,AL,44.0,F,"Patient stated that she felt hot, internally. She then felt faint, dizzy. Her BP was elevated (115/99 mmHg) but pulse was normal (65 bpm). It did continue to change throughout her waiting/observation period (highest BP 158/110 mmHg and pulse 78 bpm). We observed her for 40 minutes when she stated that she felt ok to go home and rest. At that time her BP had normalized.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PHM,Not Known,None,Not known.,,None,"['Blood pressure increased', 'Dizziness', 'Feeling hot']",1,MODERNA,IM 920718,MA,31.0,M,"1 week post vaccine last evening approx 1130 pm while putting steroid cream (treatment for eczema) noticed right shoulder area red, warm and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,PVT,Zyrtec albuterol inhaler prn,None,eczema asthma occasional heartburn,,nka,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 920719,PA,36.0,F,"starting to feel lethargic and weak. Had menses with increased blessed. Called physician to have blood work done to see if I was experiencing anemia. Blood work complete on 12/31/2020. On 1/3/2021, I woke up with blood blisters all over the inside of my mouth and petechia on my trunk and bilateral upper and lower extremities. I called my primary physician to report the symptoms. He suggested to go to the ER if my symptoms worsened. Later that evening I started with a nose bleed and did go to the ER. Upon arrival to the ER, my platelet count was 9. I was admitted to the hospital and diagnosed with ITP.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/23/2020,12/28/2020,5.0,PVT,none,none,none,,none,"['Asthenia', 'Blood test', 'Epistaxis', 'Immune thrombocytopenia', 'Lethargy', 'Menorrhagia', 'Oral blood blister', 'Petechiae', 'Platelet count decreased']",1,PFIZER\BIONTECH,IM 920720,MA,57.0,F,"Seven days after vaccine given, there was a lump at the site of injection, two days after that (9d after) there is a red rash 3in x 3 in and the are is hard. Today I iced it and last night I took Motrin",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/28/2020,0.0,WRK,,,,,,"['Induration', 'Injection site mass', 'Rash erythematous']",1,MODERNA,IM 920721,OR,33.0,F,"came to clinic 1/5/21. states had vaccine 12/28/20. noticed last night arm itching, tender, hot, redness. marked redness - approx. 1.5 x 2 inches. redness size not changed, shifted position slightly (less than 1/4 inch). warm to touch. has not taken meds",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,none,states none,states none,,states none,"['Erythema', 'Pruritus', 'Skin warm', 'Tenderness']",1,MODERNA,IM 920722,MI,54.0,F,"Started to feel dizzy about9 hours after the vaccine. Went to bed. Woke up at 6:20 AM with nausea and a tremendous headache - 8 out of 10. Took 325 mg Tylenol and helped a little - 7 out of 10. Slept a couple of hours and the headache was still 7 out of 10. Took 650 mg Tylenol, ate some veggie straws, and drank some Focus Aid. After about 1/2 hour the headache was a 4/10. 2 hours later and headache remains, currently 5/10.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,Multivitamin and Vitamin D,None,Tendonosis of right elbow,,PCN,"['Dizziness', 'Headache', 'Nausea']",1,PFIZER\BIONTECH,IM 920723,KY,45.0,F,"RED, SWOLLEN, PAINFUL AREA AT INJECTION SITE (HOT TO THE TOUCH) JOINT PAIN IN ELBO AND SHOULDER MUSCLE PAIN IN ARM INJECTED",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/30/2020,8.0,PUB,MELETONIN MOTEGRITY PROTONICS MOTOPROL MUSCLE RELAXER,NONE,GASTRO PARESIS DIABETIC,,NONE,"['Arthralgia', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Skin warm']",UNK,MODERNA, 920725,IA,43.0,F,"began with nausea and headache, progressing to body aches, fever of 101. Fever lasted 48 hours, headache for 4 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,"cymbalta 30mg daily, omeprazole 40mg daily",none,"arthritis, gerd",,none,"['Headache', 'Influenza virus test negative', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 920726,KY,48.0,F,"12/31/20 around 11am Numbness in right hand and right cheek, 5 minutes later, slurred speech. Episode lasted approximately 10 minutes. Treated in ER. Labs, MRI, all normal 1/3/21 Swollen lymph node to left axilla 1/4/21 Rash to injection site",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/29/2020,12/31/2020,2.0,PVT,None,None,None,,None,"['Dysarthria', 'Electrocardiogram normal', 'Full blood count normal', 'Hypoaesthesia', 'Injection site rash', 'Lymphadenopathy', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging neck', 'Platelet count normal', 'Troponin normal']",1,MODERNA,IM 920727,,29.0,F,"Mild nausea (dizziness, tightness in jaw, sour taste in mouth, stomach pain) 5-10 minutes after injection. Muscle soreness at injection site beginning in the evening.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,None,Common Cold,Endometriosis,,None,"['Abdominal pain upper', 'Dizziness', 'Dysgeusia', 'Injection site pain', 'Muscle tightness', 'Nausea']",UNK,PFIZER\BIONTECH, 920728,NE,37.0,M,"DEVELOPED CONTINUOUS CHEST PAIN WHEN BREATHING IN. WAS SENT TO THE EMERGENCY ROOM. WAS SEEN IN ER AND DISCHARGED AFTER OBSERVATION PERIOD. ER PROGRESS NOTE: Patient is a 37 y.o. male who arrived by Home presented to the emergency department for Chest pain. Patient states that approximately 15 this morning he received a Covid vaccine and approximately 1 hour later he started to have chest pain. Patient describing chest pain as sharp, left-sided, nonradiating, nonexertional, only occurring with taking a big deep breath, has never had similar symptoms before, not improving with home baclofen, currently a 3-4 out of 10, not occurring at rest only with deep breath. Patient states that he became concerned that it was a side effect of the vaccine and came to ED for further evaluation. Patient just denies any associated shortness of breath, nausea or vomiting. Patient states he has history of bipolar, takes no mental and has been taking as prescribed. Patient states he is otherwise healthy. Patient works at a healthcare facility, has a weekly Covid antibody test which is was been negative, denies any other associated symptoms today. Patient is a daily smoker, no history of blood clots, no recent travel or surgeries. Patient denies any headache, change in vision, nausea, vomiting, neck pain, back pain, fever, chills, shortness of breath, abdominal pain, flank pain, change in urination, diarrhea, constipation, rashes, lightheadedness, dizziness, or any other associated symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,,,,,,"['Chest pain', 'SARS-CoV-2 antibody test negative']",1,PFIZER\BIONTECH,IM 920729,FL,48.0,F,"red lump on arm where injected . its hot and swollen . the next day after the shot I had a fever , muscle and joint aches and pains . exhaustion . the red lump grew and is still with me 2 weeks after the shot .",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,01/05/2021,13.0,PVT,"atenolol , tirosint , triamterene HCTZ, hydrocodone , butalbital , amitriptyline, cycloset, benedryl, lyrica, omeprazole , fenofibrate , potassium ,",,"migrains , high blood pressure , IBS , hypothyroid , diabetes , asthma",,"Aspirin , all N' saids , ampicillin , keflex","['Arthralgia', 'Fatigue', 'Injection site erythema', 'Injection site nodule', 'Injection site swelling', 'Injection site warmth', 'Myalgia', 'Pyrexia']",1,MODERNA,SYR 920730,PA,41.0,M,"headache approximately 4 hours after vaccine , treated with OTC ibuprofen. symptoms resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,Flomax 0.4mg po qHS Pepcid 40mg po qHS,COVID 19 + 12/12/2020,asthma low back pain GERD BPH,,none,['Headache'],1,PFIZER\BIONTECH,IM 920731,NY,59.0,F,same night nausea and vomited. 12 days later 1/2/21 woke up with stiff knees/wrists and joint pain swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,"blood pressure med, multi vitamin",,hypertension,,,"['Arthralgia', 'Joint stiffness', 'Joint swelling', 'Nausea', 'Vomiting']",1,MODERNA,IM 920732,OH,32.0,F,"Migraine, nausea, fever, shivering/chills, full body aches, joint/bone pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,WRK,Lexapro methocarbamol Claritin Tylenol,Na,Na,,Codeine,"['Arthralgia', 'Bone pain', 'Chills', 'Migraine', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 920733,MA,28.0,F,"I had t sit in the room for observation for 1/2 an hour no symptoms. returned to work and no problems. Then about 3 hours after I received the vaccine I started having nausea and some hand tingling on and odd. The biggest limiting symptom was the excruciating shoulder pain on the left arm, no relief with ibuprofen, Tylenol, ice, changing position nothing. Worse pain I had in my life. I could not move my arm on its own at all and it was excruciating pain. Went to the ER and they gave me IV fluids and tramadol. The pain was better after that but I still could not move the arm and the pain was still present. They made me follow up with my PCP. I saw my PCP on a Tuesday after being on and off the phone with them on a Mondays. Symptoms have improved but not back to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,"Trisprintec, Vitamin D and B12 and Folate",No,No,,Zithromax,"['Injected limb mobility decreased', 'Injection site pain', 'Magnetic resonance imaging', 'Nausea', 'Pain', 'Paraesthesia', 'X-ray limb']",1,MODERNA,SYR 920735,IL,48.0,F,"NAUSEA, VOMITING, FEVER, SORE TO INJECTION SITE, BODY MALAISE, FATIGUE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,NONE,NONE,NONE,,NONE,"['Fatigue', 'Injection site pain', 'Malaise', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 920736,VA,59.0,F,"Development of tinnitus/ringing sensation/buzz as a ""generalized sensation"" that is generally not pleasant. Within first 24 hours after administration patient had regular side effects including headache, fever (99.8) , and chills that disappeared after 36-48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PVT,Armour thyroid 60mg qd,NONE,obesity,,NKDA,"['Chills', 'Headache', 'Pyrexia', 'Tinnitus']",1,PFIZER\BIONTECH,IM 920738,PA,48.0,F,Employee developed large reddened area at site of injection. Employee completed a telehealth visit with provider who encouraged her to ice and continue to monitor site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,,,,,,['Injection site erythema'],1,MODERNA,IM 920739,CA,29.0,U,"Associate came back post vaccine after leaving, left hand fifth digit numbness and tingling. VS: T 97.7, HR 61, BP 129/84. Doctor notified, 12:40pm doctor monitored for 25 minutes, patient reported no other symptoms and stated he wanted to leave and was feeling better.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,Unknown.,Unknown.,Unknown.,,No known allergies.,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 920740,CA,55.0,F,"6 days after my shot, I developed an itchy rash with moderate swelling on face mostly, neck and wrists. I am not sure of the cause - it was clearly some kind of allergy, possibly a contact allergy, but I am not sure if it is connected to the vaccine or not. I was advised to report it. It was bad enough to have been prescribed prednisone",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/28/2020,6.0,PVT,None,None,None,,None,"['Rash', 'Rash pruritic', 'Swelling face']",1,PFIZER\BIONTECH,IM 920741,OK,37.0,F,Fast heartbeat (between 126-130 HR per minute),Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,WRK,"Vitamin C, Vitamin D3, B-Complex, Potassium.",NKDA,NKDA,,"Latex, Morphin",['Heart rate increased'],1,PFIZER\BIONTECH,IM 920742,NY,55.0,F,"Moderna COVID-19 Vaccine EUA Rapid heartbeat, extreme light headedness within 5 minutes, eyes bothered me, was wheeled to ER (1/4/2021) Still a little light headed (much better than yesterday), muscle aches legs and back (1/5/2021)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Levothyroxine Pantoprazole Latanoprost Tumeric,none,none,,Levaquin,"['Back pain', 'Blood test', 'Dizziness', 'Eye irritation', 'Heart rate increased', 'Myalgia']",1,MODERNA,SYR 920743,IL,54.0,F,"Developed multiple erythematous patches/hives to R lower abdomen covering an area of approximately 17cmx28cm in size. Patches are erythematous, pruritic and appear to have a central clearing. Pt tried applying a topical anti-fungal cream initially, but it did not help. Also applied a regular topical emollient which also did not help.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/03/2021,3.0,MIL,Atenolol 25 mg hs ASA 81 mg qd Zetia 10 mg qd Ranitidine 300 mg hs Metformin 1000 mg bid Prevacid 30 mg qd Allegra 180 mg qd Mature multivitamin qd B complex qd Nasonex 2 sprays hs Advair 250/50 2 puffs qd Albuterol inhaler qid PRN Albutero,Denies illness in month prior to vaccination,"Asthma, GERD, Migraines",,Sulfa drugs Latex,"['Pruritus', 'Rash erythematous', 'Urticaria']",1,PFIZER\BIONTECH,IM 920744,IL,31.0,F,"Vomiting, Body ache, Headache, Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,SEN,,,None,,,"['Headache', 'Pain', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 920745,CA,35.0,M,"pruritic rash started on the ipsilateral elbow flexor, spread to wrist, web spaces, then all flexor folds in all 4 limbs. These lasted for about 5-7 days and disappeared on their own. I did not take any medication or apply any creams or ointments.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,none,some flu-like symptoms before holiday,none,,none,"['Rash', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 920746,MN,32.0,F,"Within 5 hours I broke out in a rash all over my body, horrible piercing headache, became dizzy, became diaphoretic and feverish , horrible muscle body aches hurt to the bone , left arm burned and could barely lift it . Felt very confused totally brain fog and extremely fatigued. I took benadryl and tylenol. I came home from work and went to bed and couldn't function until Friday. I slept all of Thursday . By Saturday my rash subsided, I felt ok enough to function but haven't felt 100 % since.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,No,No,No,,No,"['Bone pain', 'Confusional state', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Headache', 'Hyperhidrosis', 'Mobility decreased', 'Myalgia', 'Pain', 'Pyrexia', 'Rash', 'Skin burning sensation', 'Somnolence']",1,MODERNA,IM 920748,PA,46.0,F,"At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen and tried to go to sleep. I was unable to sleep on my left side as normal. Around 12:30am I woke up cold, shivering violently, with a fever of 103.�3. My feet were also burning. I woke up around 2:30am. Fever was down to about 102.4�, feet were still burning and my face and eyes were swollen. I took more ibuprofen and put used cold compress on my eyes. Around 4:30am I woke up with abdominal pain and pain in my hips. Fever was lower, eyes were better but face still swollen and feet still burning. I called off work at that time. By about 8am fever broke and have just had an intense headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/04/2021,3.0,PVT,"Metphormine, glimepiride, Jaurdiance, losartin, creator, Buspar, Trazadone, synthroid, vitamin B, D, and E, acidophilus, fiber",Sinus irritation/allergies,"Diabetes, hypothyroidism, anxiety",,Acetaminophen,"['Abdominal pain', 'Axillary pain', 'Breast pain', 'Burning sensation', 'Chills', 'Eye swelling', 'Feeling cold', 'Headache', 'Hip arthroplasty', 'Injection site pain', 'Pain', 'Pyrexia', 'Swelling face']",1,PFIZER\BIONTECH,SYR 920749,IL,60.0,F,"BODY MALAISE, SORE TO INJECTION SITE, HEADACHE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,NONE,NONE,HTN,,NONE,"['Headache', 'Injection site pain', 'Malaise']",1,MODERNA,IM 920750,MN,31.0,M,"Vision changes (things became ""pixelated""), Cough (slight bronchospasm), arm numbness/decreased strength in administration arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,none,none,increased heart rate,,vancomycin,"['Bronchospasm', 'Cough', 'Hypoaesthesia', 'Laboratory test normal', 'Metamorphopsia', 'Muscular weakness']",1,MODERNA,IM 920753,NJ,43.0,F,"Symptoms started day after receiving vaccine. Started with a rash on upper back that itched and burned for a few days, followed by whole body burning and sweating with rash on lower arms and chest along with continued rash on upper back. These symptoms come and go and are worse on different days. This continues today and I have been advised by my healthcare provider not to receive second dose which was scheduled for today 1/5/21. I did take steroids for two days but then was advised by physician to allow my body to react if I can tolerate the symptoms. Symptoms are tolerable some days but not all. No fever with the burning and sweating. No other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/20/2020,1.0,PVT,,,,,,"['Burning sensation', 'Hyperhidrosis', 'Rash', 'Rash pruritic']",1,PFIZER\BIONTECH,SYR 920754,PA,37.0,F,Employee developed swelling and increasing pain in armpit of arm that received vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PVT,,,,,,"['Injection site pain', 'Injection site swelling']",1,MODERNA,IM 920755,NV,43.0,F,"fever, pain at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Injection site pain', 'Pyrexia']",1,MODERNA,IM 920756,MT,41.0,F,PT experienced itchiness and a sore arm on 12/23/2020. Developed hives on 1/5/2021 at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/05/2021,13.0,PVT,"birth control -unknown, hydrochlorothiazide, vitamin D, loratadine",none,"hypertension, asthma",,non,"['Injection site urticaria', 'Pain in extremity', 'Pruritus']",1,PFIZER\BIONTECH,IM 920757,,42.0,F,"infection in L nostril and pain radiating to L eye, impacting vision",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/29/2020,1.0,UNK,,,Previous reactions to flu vaccine,,,"['Eye pain', 'Pain', 'Sinusitis', 'Visual impairment']",1,PFIZER\BIONTECH,IM 920758,CA,45.0,U,"Delayed response between 12 - 24 hours after vaccination. Headache, muscle aches, extreme fatigue, shivering alternating with feeling feverish. Already had COVID (estimated to be between 2 to 3 months ago).",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PVT,unknown,unknonwn,unknown; did have COVID recently,,unknown,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 920759,MO,49.0,F,"My arm is swollen, red and is very hot to the touch. It is also very hard and the size of a softball",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,UNK,"Lantus ,Ozempic, Metformin, Lisinoprl, Humalog,",,"DIABETES,HIGH BLOOD PRESSURE",,,"['Erythema', 'Induration', 'Peripheral swelling', 'Skin warm']",1,MODERNA,SYR 920760,TN,40.0,F,Low grade fever of 99.9 being the highest; Fatigue; Muscle Soreness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,Lisinopril 20mg daily Prozac 20mg daily One a day gummy vitamins 2 daily,,Hypertension Obesity Pre-diabetic,,,"['Fatigue', 'Injection site pain', 'Pyrexia']",1,MODERNA,IM 920761,IL,57.0,F,"I had most of the side effects listed, but the one that is still bothering me til this day is that my heart feels like its racing, beating fast and sometimes feels likes its pounding, very uncomfortable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Allegra 180mg, daily, daily vitamins, nasonex, symbicort inhaler, ventolin inhaler, as needed, also netipot as needed. I take these medications daily,but I didn't take just yet at date of vaccination because I came out from work and had va",none,"allergies, and developed asthma because of allergies.",,"Lots of allergies: Latex, all sea food, cats, dogs, feathers, dust mites, seasonal and other stuff, corn starch, Kathon CG-methylchoroisothiazolinone, methylisothiazolinone, preservatives in skin care products, shampoos, I was to beware of hand cleanser at hospital, Formaldehyde. avoid any morgue exposure and biopsy specimen bottles.",['Palpitations'],1,PFIZER\BIONTECH,IM 920764,VI,38.0,F,"Itchy scalp, forearms, upper back; went to ER and received Benadryl and Solumedrol, then got ""ball in throat"" and neck redness - received Epinephrine; all cleared in 2 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,xyngular dietary supplement,None,None,,Keflex,"['Erythema', 'Pruritus', 'Sensation of foreign body']",1,MODERNA,IM 920765,NC,35.0,F,Abnormal taste in the back of my mouth. Has been going on since vaccination sometimes more pronounced then others. Almost like a constant bitterness taste .,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,PVT,"Zinc, Vit C, Vit D,",none,"obesity, Back issues",,"MSG, Omnicef, adhesive","['Dysgeusia', 'Taste disorder']",1,MODERNA,IM 920766,CA,35.0,F,"Light headed and reports a feeling of motion sickness describes it as a wave that starts from abdomen up to chest area. Later in the day patient reports a feeling of being lost/confused, tiredness and still has motion disturbance.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,unknown,unknown,unknown,,NKDA,"['Confusional state', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Motion sickness']",1,MODERNA,IM 920767,NY,27.0,M,"I would like to start out by saying that I am well aware that this vaccine is known to cause side effects and that the benefits of the vaccine far outweigh any side effects induced by it. The reason I am writing this is to provide information that you all can keep in mind as you provide guidance on your recommendations for the timing of when the vaccine should be administered to those who have already tested positive for COVID. I tested positive for COVID-19 11 days prior to getting vaccinated. My symptoms from the virus began on 12/21/20, lasted until 12/26/20 and included: mild headache, fever of 100.3, moderate muscle fatigue, lymphadenopathy, and sinus congestion. I received the Pfizer vaccine on 1/3/21 at 11am and by 2am on 1/4/21 I was experiencing a temperature of 102.5, severe headache, severe muscle fatigue, and painful right axillary lymphadenopathy. Although they had almost completely resolved by 11am on 1/4/20, I would describe these side effects to the vaccine as significantly worse than the symptoms of the virus itself. As someone who has a stronger medical background than the general public (I am a 4th year dental student in a patient-facing role and was encouraged by my school to receive the vaccine despite already testing positive), I understood the likelihood of developing side effects to the vaccine and I am still planning on receiving my second dose in three weeks despite already showing clear signs of a strong immune response to the proteins created by the vaccine. The reason why I am writing this is because there was no guidance on recommending that I wait longer than 10 days between testing positive and receiving the vaccine and I am worried that if the general public is allowed to receive the vaccine at this same time interval, there will be a significant number of people who will have similar side effects (worse than those induced by the virus itself) and they will not only refuse a second dose, but could also vocally discourage many people from trusting the vaccine?s safety and benefit. I obviously don?t know what minimum timeframe should be recommended, but from my individual experience, 11 days was not sufficient. I will be happy to follow up if you would like to know how the symptoms fare after my second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,None,Positive COVID PCR rapid test,None,,None,"['Body temperature increased', 'Condition aggravated', 'Headache', 'Lymphadenopathy', 'Muscle fatigue']",1,PFIZER\BIONTECH,IM 920768,TX,70.0,M,"Day one - Mild headache, sore arm at injection site, chills Day two (today) - Sore arm remains, new mild joint pain in both knees, headache gone and chills gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,PHM,"Metatoprolol, plavix, topamax, baby asprin, linsinopril",,Heart Disease,,,"['Arthralgia', 'Chills', 'Headache', 'Injection site pain']",UNK,MODERNA,IM 920769,NY,72.0,M,"( I am a physician )First 24-36 hours noted minimal site discomfort. On 1/1/21 @ 6 PM with dinner noted some difficulty chewing food and minor sensation on right lower lip. As evening progressed it was noticeable a small right facial droop and distorted smile. By 1/2/21 5 AM, facial droop was more noticeable as well as distorted smile. So I decided to to ED to be checked out.ED MD was contemplating between unusual presentation of Bell's Palsy, small stroke or COVID 19 presentation. Vitals except for slightly elevated BP (145/85) were NLas well as lab ( see below). PEx: tender area posterior to R Jaw. So left with Right madibular trigeminal inflammation ( limited Bell's Palsy) and consideration for steroids. I opted NO steroids since I wanted to COVID vaccine response. Since it was a holiday weekend, I finally got to talk to my PCP on 1/4/21 ( Dr, from Internal Medicine at Hospital) who agree with me n no steroids. Also no vaccine until we see course and newer recommendations over next few weeks from CDC. I am being monitored with CDC text messaging but have not received a call from them yet. since 1/1/2021 there has been improvement in that there tenderness behind the right jaw is gone. There are no new symptoms but he weakness of right lower lip and eating issues persists. When a move water around in my mouth with closed lips , it tends to leak on right side. I am hoping for full recovery but time will tell. Summary of ED physician assessment from 1/2/21 Medical Decision Making Patient seen by me on: 1/2/2021 Assessment: 72 year old male presenting with right sided facial weakness. No paralysis on exam but mildly notably weaker on R side. Otherwise, neurologically intact on exam. Differential diagnosis: Bell's Palsy, Incomplete Bell's Palsy, CNS lesion, vaccine adverse effect, lymphadenopathy Considered CVA, not a TPA candidate based on timing and minor deficits. May need to obtain MRI to evaluate. Plan: EKG, basic labs Discussed with patient, who is a physician, given risk factors and not classic Bell's Palsy, will proceed with MRI brain. ED Course and Disposition: MRI unremarkable. I feel this adequately rules out stroke and CNS lesion as a cause of facial weakness. CBC, CMP unremarkable. Patient's exam remains stable. We discussed risks/benefits of steroids. Concerns being his diabetes as well as blunting immune response to vaccine. He has mild facial asymmetry but not complete and will hold off on steroids unless worsening symptoms. COVID testing sent as discussed with patient. He will return to ED or see PCP if symptoms worsen. Dx- Bell's Palsy 01/02/21 1231",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,WRK,"atorvastatin 40 MG tablet/d;lisinopril 20 MG tablet/d; other medications at the time :metFORMIN 850 MG tablet BID, levothyroxine 50 MCG tablet /d; liraglutide 18 MG/3ML injection pen 1.8 mgs nightly; co-enzyme Q-10 100 MG capsule/d; aspirin",no acute illness,"Diabetes, Hypertension, Gout, Plantar faciitis,",,none,"['Blood glucose increased', 'Blood pressure increased', 'Electrocardiogram normal', 'Facial paralysis', 'Full blood count normal', 'Injection site discomfort', 'Laboratory test normal', 'Magnetic resonance imaging', 'Mastication disorder', 'Pain in jaw', 'SARS-CoV-2 test negative', 'Trigeminal nerve disorder']",1,MODERNA,IM 920770,FL,55.0,F,"2O MINUTES FOLLOWING INJECTION PATIENT SWELLING OF TONGUE AND THROAT, TASTE CHANGE, DIZZINESS AND RAPID HEART RATE. IMMEDIATELY TOOK BENADRYL TOOK 2 HOURS TO DECREASE SYMPTOMS.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,none,none,hx of tachycardia,,bee stings,"['Dizziness', 'Heart rate increased', 'Pharyngeal swelling', 'Swollen tongue', 'Taste disorder']",1,MODERNA, 920771,IL,94.0,F,"Tachycardia, resident was sent out to the hospital for evaluation on 12/30/2020 and came back to the facility on 12/31/2020.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/29/2020,12/30/2020,1.0,SEN,,,,,NKA,['Tachycardia'],1,MODERNA,IM 920772,NJ,26.0,F,"I received my first dose of the COVID-19 Moderna vaccine on 12/29 at 12:40p at Medical Center in my left deltoid. I am a registered nurse at the facility. Starting on 12/30 when I woke up, I had a mild headache. The headache is lingering and intermittent. Starting 1/3, I have a swollen and sore lymph node in my left armpit (the same side I received the vaccine). My employer is sending me for a COVID-19 PCR today to rule out any active infection. Tylenol has been taken as needed for the headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,Zyrtec daily as needed,None,None,,"Hazelnut (hives), Azithromycin (anaphylaxis), Propylene glycol (angioedema)","['Headache', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 920773,OH,51.0,M,"1-3-2021 10:30 PM Itchy legs rash on legs and arms took hot shower went to bed went away by morning. 1-4-2021 12:00 PM started to have itchty hands itchy back itchy legs itchy elbows rash around eyes got home at 5:00 PM had rash on legs, back, arms, eyes, took Benadryl 25 mg took shower the itchy slightly eased and rash lightened up but didn't go away. went to bed. 1-5-2021 6:00 am woke up rash almost gone on back but had itchy ankles and wrists and the back of my arms. took Benadryl 25 mg before work got to work and had extremely itchy hands and slight rash in all the same spots. and itching has became less after 6 hours. 1-5-2021 12:23 pm filled out this form",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/03/2021,4.0,PVT,Atenelol Atorvastatin Diazide Lisinopril 81 mg Aspirin Elederberry,none,high blood pressure,,none,"['Pruritus', 'Rash']",1,MODERNA,IM 920774,MD,56.0,F,Patient was vaccinated on 12/28/20. On 12/29/20 she developed some reddish area around 2cm in diameter at the injection site with slight itching and discomfort. Besides this there were no other complains,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,"Hypertension, A. fib, schizoaffective d/o, obesity, GERD",,Latex,"['Injection site discomfort', 'Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 920775,MO,36.0,F,"Pt reports tingling and sweating to R side of the body (face, arm, and leg). Reports HA R side of body. As evening progressed, patient reports worsening HA and vomiting. Pt reports pain in R arm and swelling in armpit area. Reports s/s resolved the next day. Recommended f/u with PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,unknown,unknown,unknown,,NKA,"['Headache', 'Hyperhidrosis', 'Oedema peripheral', 'Pain in extremity', 'Paraesthesia', 'Vomiting']",1,PFIZER\BIONTECH,IM 920776,PA,28.0,M,"Pt. states that he received covid Pzifzer vaccine at 11:17 am on 01/05/2021 to left deltoid IM. Around six to seven minutes at 11:23 am post vaccination patient started having burning sensation at site, felt flushed, diaphoretic, light-headed, nauseated, and now he is experiencing tingling to bilateral feet. Pt. states that earlier post vaccination he was feeling anxious, but he is no longer feeling anxious. Pt. denies feeling this way post vaccination with other vaccines. Pt. states that he is still having bilateral feet tingling up to both calves right greater than left.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,OTH,denies,denies,denies,,nkda,"['Anxiety', 'Dizziness', 'Flushing', 'Hyperhidrosis', 'Injection site pain', 'Nausea', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 920777,MT,43.0,M,"Chronic headache and stuff neck, sore shoulder",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,MIL,None,None,None,,No,"['Arthralgia', 'Headache', 'Musculoskeletal stiffness']",1,PFIZER\BIONTECH,IM 920778,SD,65.0,M,"Moderna COVID-19 Vaccine EUA Woke up at 1:30 AM to get drink of water, feeling somewhat lightheaded. Vomited and a few minutes later experienced diarrhea. Went back to sleep, woke up at 7:00 AM. Diarrhea again. Experienced slight headache and some lethargy. Can eat and drink but decided to fast for the day and just drink water. Went to work as usual. I believe I am recovered now.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"Fish oil, turmeric, Magnesium Citrate, I-Caps (Lutein & Zeaxanthin), D3 5000 with K2, Glucosamine & Chondroitin, manganese 2 mg",None,Rheumatoid arthritis (haven't taken prescribed meds for this since March 2020),,Latex,"['Diarrhoea', 'Dizziness', 'Headache', 'Lethargy', 'Vomiting']",1,MODERNA,IM 920779,CT,26.0,F,"Patient has some tachycardia and dizziness on the day of vaccination. Developed rash at injection site 4 days later, which is itchy, tender, and inflamed.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/27/2020,12/31/2020,4.0,PVT,,,,,,"['Dizziness', 'Injection site inflammation', 'Injection site pain', 'Injection site reaction', 'Rash pruritic', 'Tachycardia']",1,MODERNA,IM 920780,NM,39.0,F,"PT was verbalizing prior hesitancy to vaccine once received @ 10:58 - 3 minuets post injection PT C/O neck/ throat feeling tight, sis increased to C/O feeling like heart was racing, feeling diaphoretic and shaky. EMS called to car for assessment BP- 156/106 pulse - 110 follow pulse - 76 BP- 132/87. PT up and standing to help case symptoms PT had also C/O L side pain after dose administered, 11:30 patient states she starts to feel ok, then she no longer feels ""normal"" C/O heaviness in head/ neck.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/18/2020,0.0,OTH,,,,,,"['Hyperhidrosis', 'Nervousness', 'Pain', 'Palpitations', 'Throat tightness']",UNK,PFIZER\BIONTECH,IM 920781,OK,42.0,F,"I had fatigue and body aches for 4 days I woke up Sunday morning and I had a huge swollen lymph node the size of a golf ball at the base of the right side of my neck that lasted for 2 days, I was put on ogmentin for 5 days and it went away after that",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,"sudafed otc, flonase, bupronsar 100mg, estrace 1mg, 30mg diltiusane, velcyclovere 500mg, rabplaze 20mg, triamtereme 37.5 mg hctz 25 mg I only take half of that in a day for high blood pressure and edema in my legs, proair inhalor, steroid",sinus congestion,"asthma, high BP, irregular heartbeat, acid reflux, edema in my legs",,"tramadol, biactin","['Fatigue', 'Lymphadenopathy', 'Pain']",1,PFIZER\BIONTECH,SYR 920783,KS,84.0,M,Nausea/Vomiting Weakness Low Grade Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,SEN,,,,,,"['Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 920784,IN,44.0,F,"Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 . Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more meds naproxen",Not Reported,,Yes,Yes,4.0,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,None,None,None,,None,"['Anaphylactic reaction', 'Anxiety', 'Blood test', 'Burning sensation', 'Central nervous system lesion', 'Chest X-ray', 'Differential white blood cell count', 'Dizziness', 'Dysphagia', 'Ear pain', 'Electrocardiogram', 'Erythema', 'Flushing', 'Full blood count', 'Headache', 'Hypertension', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Magnetic resonance imaging brain abnormal', 'Metabolic function test', 'Mobility decreased', 'Palpitations', 'Paraesthesia', 'Paraesthesia oral', 'Peripheral swelling', 'Pharyngeal swelling', 'Swelling face']",1,PFIZER\BIONTECH,SYR 920785,NY,68.0,F,Patient received COVID19 vaccine (Moderna) and felt flushed afterwards requiring an ED visit. In the ED she received diphenhydramine 50mg PO and prednisone 60mg PO x1 dose each. Patient symptoms improved and patient was discharged.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,None,,,None,['Flushing'],1,MODERNA,IM 920786,AR,60.0,M,Shoulder/arm pain; change in LOC; Labs pending,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,SEN,"Eliquis Tablet 5 MG (Apixaban) Give 1 tablet by mouth two times a day related to CEREBROVASCULAR DISEASE, UNSPECIFIED (I67.9) Phone Active 09/02/2020 09/02/2020 Multi-Vitamin/Minerals Tablet (Multiple VitaminsMinerals) Give 1 tablet by mout",,"ACUTE AND CHRONIC RESPIRATORY FAILURE WITH HYPOXIA NTA (1 pts) Pulmonary 9/2/2020 Principal Diagnosis (#67) Admitting Dx (#69) 9/16/2020 update M86.161 OTHER ACUTE OSTEOMYELITIS, RIGHT TIBIA AND FIBULA NTA (2 pts) Non-Surgical Orthopedic/Musculoskeletal 7/15/2020 Dx During Stay 7/15/2020 update Z68.41 BODY MASS INDEX [BMI]40.0-44.9, ADULT NTA (1 pts) N/A, not an acceptable Primary Diagnosis 7/15/2020 Dx Admission 7/15/2020 update T81.30XS DISRUPTION OF WOUND, UNSPECIFIED, SEQUELA Medical Management 6/27/2019 Dx Admission 6/27/2019 update I67.9 CEREBROVASCULAR DISEASE, UNSPECIFIED Medical Management 3/3/2017 Dx History 9/7/2017 Bulkload update G82.21 PARAPLEGIA, COMPLETE Acute Neurologic 10/1/2015 Dx History 7/28/2020 update T50.B95A ADVERSE EFFECT OF OTHER VIRAL VACCINES, INITIAL ENCOUNTER N/A, not an acceptable Primary Diagnosis 1/4/2021 Secondary 1/4/2021 update R09.81 NASAL CONGESTION N/A, not an acceptable Primary Diagnosis 10/16/2020 Secondary 10/16/2020 update R06.02 SHORTNESS OF BREATH N/A, not an acceptable Primary Diagnosis 7/20/2020 Secondary 7/20/2020 update V00.812D WHEELCHAIR (POWERED) COLLIDING WITH STATIONARY OBJECT, SUBSEQUENT ENCOUNTER N/A, not an acceptable Primary Diagnosis 6/27/2019 Secondary 6/27/2019 update K59.00 CONSTIPATION, UNSPECIFIED N/A, not an acceptable Primary Diagnosis 10/5/2018 Secondary 10/5/2018 update M62.00 SEPARATION OF MUSCLE (NONTRAUMATIC), UNSPECIFIED SITE N/A, not an acceptable Primary Diagnosis 10/5/2018 Secondary 10/5/2018 update R13.0 APHAGIA N/A, not an acceptable Primary Diagnosis 10/5/2018 Secondary 10/5/2018 update R13.10 DYSPHAGIA, UNSPECIFIED N/A, not an acceptable Primary Diagnosis 10/5/2018 Secondary 10/5/2018 update I10 ESSENTIAL (PRIMARY) HYPERTENSION N/A, not an acceptable Primary Diagnosis 3/3/2017 Secondary 9/7/2017 Bulkload update E56.9 VITAMIN DEFICIENCY, UNSPECIFIED Medical Management 3/3/2017 Secondary 9/7/2017 Bulkload update E78.5 HYPERLIPIDEMIA, UNSPECIFIED Medical Management 3/3/2017 Secondary During Stay 9/7/2017 Bulkload update G60.9 HEREDITARY AND IDIOPATHIC NEUROPATHY, UNSPECIFIED Acute Neurologic 3/3/2017 Secondary During Stay 9/7/2017 Bulkload update G82 PARAPLEGIA (PARAPARESIS) AND QUADRIPLEGIA (QUADRIPARESIS) No clinical category mapped by CMS 3/3/2017 Secondary During Stay 9/7/2017 Bulkload update R60.9 EDEMA, UNSPECIFIED N/A, not an acceptable Primary Diagnosis 3/3/2017 Secondary During Stay 9/7/2017 Bulkload update R56.9 UNSPECIFIED CONVULSIONS Medical Management 3/3/2017 Secondary During Stay 9/7/2017 Bulkload update R52 PAIN, UNSPECIFIED N/A, not an acceptable Primary Diagnosis 3/3/2017 Secondary During Stay 9/7/2017 Bulkload update K21.9 GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS N/A, not an acceptable Primary Diagnosis 3/3/2017 Secondary During Stay 9/7/2017 Bulkload update F05 DELIRIUM DUE TO KNOWN PHYSIOLOGICAL CONDITION N/A, not an acceptable Primary Diagnosis 3/3/2017 Secondary During Stay 9/7/2017 Bulkload update Z99.3 DEPENDENCE ON WHEELCHAIR N/A, not an acceptable Primary Diagnosis 3/3/2017 Secondary During Stay 9/7/2017 Bulkload update I72.8 ANEURYSM OF OTHER SPECIFIED ARTERIES Cardiovascular and Coagulations 3/3/2017 Secondary During Stay 9/7/2017 Bulkload update Y65.0 MISMATCHED BLOOD IN TRANSFUSION Converted from ICD-9-CM E876.0 MISMATCHED BLOOD IN TRANSFUSION N/A, not an acceptable Primary Diagnosis 3/3/2017 Secondary During Stay 9/7/2017 Bulkload update Z79.2 LONG TERM (CURRENT) USE OF ANTIBIOTICS N/A, not an acceptable Primary Diagnosis 2/2/2017 Secondary During Stay 9/7/2017 Bulkload update R41.841 COGNITIVE COMMUNICATION DEFICIT N/A, not an acceptable Primary Diagnosis 11/22/2016 Secondary During Stay 9/7/2017 Bulkload update E10.5 TYPE 1 DIABETES MELLITUS WITH CIRCULATORY COMPLICATIONS NTA (2 pts) No clinical category mapped by CMS 11/14/2016 Secondary During Stay 9/7/2017 Bulkload update Z51 ENCOUNTER FOR OTHER AFTERCARE AND MEDICAL CARE No clinical category mapped by CMS 11/14/2016 Secondary During Stay 9/7/2017 Bulkload update M62.9 DISORDER OF MUSCLE, UNSPECIFIED Non-Surgical Orthopedic/Musculoskeletal 11/14/2016 Secondary During Stay 9/7/2017 Bulkload update T45.515D ADVERSE EFFECT OF ANTICOAGULANTS, SUBSEQUENT ENCOUNTER N/A, not an acceptable Primary Diagnosis 11/14/2016 Secondary During Stay 9/7/2017 Bulkload update E86.0 DEHYDRATION Medical Management 11/12/2020 Other Diagnosis 11/12/2020 update Z29.9 ENCOUNTER FOR PROPHYLACTIC MEASURES, UNSPECIFIED N/A, not an acceptable Primary Diagnosis 10/21/2020 Other Diagnosis 10/21/2020 update L89.324 PRESSURE ULCER OF LEFT BUTTOCK, STAGE 4 Medical Management 10/8/2020 Other Diagnosis 10/19/2020 update G47.09 OTHER INSOMNIA N/A, not an acceptable Primary Diagnosis 9/2/2020 Other Diagnosis 9/2/2020 update M10.9 GOUT, UNSPECIFIED Non-Surgical Orthopedic/Musculoskeletal 7/14/2020 Other Diagnosis 7/14/2020 update H04.123 DRY EYE SYNDROME OF BILATERAL LACRIMAL GLANDS N/A, not an acceptable Primary Diagnosis 7/14/2020 Other Diagnosis 7/14/2020 update Z11.59 ENCOUNTER FOR SCREENING FOR OTHER VIRAL DISEASES N/A, not an acceptable Primary Diagnosis 6/24/2020 Other Diagnosis 6/24/2020 update L30.9 DERMATITIS, UNSPECIFIED N/A, not an acceptable Primary Diagnosis 5/19/2020 Other Diagnosis 5/19/2020 update S90.821A BLISTER (NONTHERMAL), RIGHT FOOT, INITIAL ENCOUNTER N/A, not an acceptable Primary Diagnosis 2/25/2020 Other Diagnosis 2/25/2020 update N39.0 URINARY TRACT INFECTION, SITE NOT SPECIFIED Acute Infections 2/24/2020 Other Diagnosis 2/24/2020 update Z79.01 LONG TERM (CURRENT) USE OF ANTICOAGULANTS N/A, not an acceptable Primary Diagnosis 11/29/2019 Other Diagnosis 11/29/2019 update R50.9 FEVER, UNSPECIFIED N/A, not an acceptable Primary Diagnosis 6/14/2019 Other Diagnosis 6/14/2019 update B96.89 OTHER SPECIFIED BACTERIAL AGENTS AS THE CAUSE OF DISEASES CLASSIFIED ELSEWHERE Acute Infections 4/23/2019 Other Diagnosis 4/23/2019 update M86.9 OSTEOMYELITIS, UNSPECIFIED NTA (2 pts) Non-Surgical Orthopedic/Musculoskeletal 12/19/2018 Other Diagnosis 12/20/2018 update E08.8 DIABETES MELLITUS DUE TO UNDERLYING CONDITION WITH UNSPECIFIED COMPLICATIONS NTA (2 pts) N/A, not an acceptable Primary Diagnosis 1/16/2018 Other Diagnosis During Stay 1/16/2018 update E87.6 HYPOKALEMIA Medical Management 11/11/2016 Other Diagnosis 9/22/2017 update F29 UNSPECIFIED PSYCHOSIS NOT DUE TO A SUBSTANCE OR KNOWN PHYSIOLOGICAL CONDITION Medical Management 3/16/2005 Other Diagnosis 3/2/2020 update G30.9 ALZHEIMER'S DISEASE, UNSPECIFIED Medical Management 3/16/2005 Other Diagnosis 3/2/2020 update F20.9 SCHIZOPHRENIA, UNSPECIFIED Medical Management 3/16/2005 Other Diagnosis 3/2/2020 update F32.89 OTHER SPECIFIED DEPRESSIVE EPISODES",,,"['Arthralgia', 'Full blood count', 'Mental status changes', 'Metabolic function test', 'Pain in extremity']",1,MODERNA,IM 920787,OR,51.0,F,"2 minutes after vaccine was administered, noticed swelling back of tongue, progressed to posterior 2/3 of tongue, tachycardia, elevated BP. Progressive angioedema involving larynx, cough, shortness of breath. No wheezing. Physical exam did do show any obvious swelling. O2 sat decreased to 80, 1st epinephrine IM administered, 50mg benadryl IV and Famotidine administered. some improvement in symptoms. In 30mins, reoccurrence of angioedema and second epinephrine vaccine administered. Monitored for 2 hours without reoccurrence of symptoms and discharged from ER.",Not Reported,,Yes,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,Bupropion 300mg Vit D3 2000IU B complex Claritin Flonase nasal spray Levonobunolol eye drops,none,Seasonal allergies Menopausal symptoms,"Stamaril- brief sensation of tongue swelling, last 10 mins. No treatment needed or administered",PCN Biaxin Trans scoplamine patch Soy,"['Angioedema', 'Blood pressure increased', 'Cough', 'Dyspnoea', 'Oxygen saturation decreased', 'Swollen tongue', 'Tachycardia']",1,MODERNA,IM 920788,CA,27.0,F,"I remainder of the day I rested. The next day I rested all day as well and was fatigued, had a mild headache, muscle aches and felt the cold shivering feeling but had no fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/02/2020,12/03/2020,1.0,PVT,Lamictal,no,no,,no,"['Chills', 'Fatigue', 'Feeling cold', 'Headache', 'Myalgia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 920789,CA,42.0,F,"About 16 hours after receiving my second dose of the covid vaccine I began to have chills, muscle aches, headache and fever of 100.8.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Levthyroxine Turmeric,None,None,,None,"['Chills', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 920792,CO,41.0,F,"Localized rash (red, raised bumbs, slightly itchy) developed at injection site 1 week after vaccination. As a precaution, took 1 Benadryl (generic) tablet and applied topical hydrocortisone cream to the rash when noticed symptoms. Rash still apparent next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,"Spironolactone, 5mg Vit D, sublingual (Zinc, Vit C, Echinechea as needed)",,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 920793,OH,28.0,F,"Redness, itching, swelling, red ring around injection site, 10 days after vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/02/2021,10.0,PVT,"Plaquenil, Zoloft, topamax, levothyroxine, mirena, aspirin",,"Lupus, stroke",,"Bactrim, estradiol, prednisone, imitrex","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 920794,WA,36.0,M,Became very anxious. He felt his heart was racing. Prone to anxiety attacks,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Famotidine,None reported,POTS,,None noted,"['Anxiety', 'Electrocardiogram normal', 'Palpitations']",1,MODERNA,IM 920796,CA,46.0,M,"Patient describes being very fatigued and a low grade headache, patient also said he was advised that his body temperature is lower than normal",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,WRK,,,,,,"['Body temperature decreased', 'Fatigue', 'Headache']",UNK,PFIZER\BIONTECH, 920797,,48.0,M,"Body aches, low fever, headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,Atenolol Wellbutrin,COVID-19,Sarcoidosis,,Bactrim,"['Headache', 'Pain', 'Pyrexia']",UNK,MODERNA, 920800,NC,39.0,F,"Day of vaccine itching and redness where bandaid was applied. One week after vaccine swelling and sadness and itching around site. Approximately 4"" x 4"" circular swelling noted. Tenderness and warmth around swelling. Benadryl and ibuprofen taken before bed and some swelling decreased, however the swelling and warmth slightly descended down arm. and area not as large but some redness still noted. Ice applied and not much help provided.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,none,None,"asthma, GERD, Psoriasis",influenza: muscle soreness slight swelling,Sulfa,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 920801,WA,29.0,F,"The morning of 1/4/20, redness and swelling at the injection was noted. A circular flat ?lump? at the site is present with mild intermittent itching. No treatment at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/04/2021,9.0,PUB,None,None,None,,None,"['Injection site erythema', 'Injection site mass', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 920802,CO,42.0,M,"3-5 hrs s/p vaccine- soreness at injection site. About 12h s/p vaccine administered (around 9p) began to experience chills, headache, fatigue. This persists/worsens accompanied by chills. Temp taken at 10p (99.1, my normal is 97.6) By 0150, temp up to 100.4 along with continuing alternating sweats/chills and persisting headache. 1000mg Tylenol used at 0150. At 0240, symptoms settle a bit and got a little sleep. 0445, woke up- headache persists. Mild chills/sweats. Afebrile at 98.6. Still fatigued. At 0800 on 1/5/21, another 1000mg Tylenol used as aforementioned symptoms worsening. Now at 1035 (time of this report), chills/sweats have settled - left with fatigue, headache, and nasal congestion. Of note, I tested positive for COVID and was sick for about 2-3 weeks in Sep 2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,MIL,Crestor,None,None,,"NKDA, none to food","['Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Nasal congestion']",1,MODERNA,IM 920803,NH,44.0,F,Onset of redness/pain/swelling into (R) UE one week after shot. Symptoms progressed into the next day. Seen at PCP office and diagnosed with cellulitis. Given script for 1 week of Cephalaxin. Also taking Ibuprofen. Redness has decreased but swelling and itchiness have continued with joint pain (R) shoulder and (R) elbow.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/30/2020,7.0,WRK,,,,,,"['Cellulitis', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 920804,OR,39.0,U,"patient reports numbness, pain, and tingling in arm; as well as Nausea and headache. Nausea and headache lasted 2 days, pain in arm persists.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,PVT,,,,,,"['Headache', 'Hypoaesthesia', 'Nausea', 'Pain in extremity', 'Paraesthesia']",UNK,MODERNA,IM 920805,OH,45.0,M,"palpitations, chest tightness/heaviness, scratchy throat/frequent throat clearing, head heaviness, blurred vision, elevated blood pressure. Evaluated in ED received solumedrol, benadryl. Discharged home and returned to hospital as direct admit due to continued symptoms. Pertinent labs reveled AKI, elevated LFTs. AKI and LFTs improved with IVFs.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,,,NKDA,"['Acute kidney injury', 'Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood alkaline phosphatase increased', 'Blood creatine increased', 'Blood pressure increased', 'Chest discomfort', 'Head discomfort', 'Liver function test increased', 'Palpitations', 'Throat clearing', 'Throat irritation', 'Vision blurred']",1,PFIZER\BIONTECH,IM 920806,PA,29.0,M,Burning down arm right after injection. Sweats and dizzy,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,,,,,,"['Dizziness', 'Hyperhidrosis', 'Injection site pain']",UNK,MODERNA, 920807,NY,21.0,F,"Night of vaccine, red raised itchy rash around injection site, foggy head feeling, left arm pain. All of these effects went away in 2 days. 8 days following administration of first Moderna dose (1/5/2020), the raised, red rash around injection site had returned (same size as before), with nausea and vomiting. Slight headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,None,None,None,,No known allergies,"['Feeling abnormal', 'Headache', 'Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Nausea', 'Pain in extremity', 'Vomiting']",1,MODERNA, 920808,,29.0,F,"sore arm at injection site, fever/chills, tachycardia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Chills', 'Injection site pain', 'Pyrexia', 'Tachycardia']",UNK,MODERNA, 920809,IL,22.0,F,"Fever 101.2, severe body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PUB,"Vitamin D weekly, B12 supplement and fish oil daily",No,None,,NKA,"['Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 920811,NJ,54.0,F,"fever ,chill and achiness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,tylenol,NONE,Hypertension,,NKA,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 920812,WA,28.0,F,Extreme nauses,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,NONE,None reported,None,,NONE,['Nausea'],1,MODERNA,IM 920814,CA,38.0,F,"She received the Moderna vaccine on 12/28. She then started to feel some itching in her throat within 5 minutes. It then started to get worse and then she started to cough. Vital signs show blood pressure 152/89 with pulse 72 oxygen saturation 100% with respiratory to 16. She was given liquid Benadryl and the coughing and itchiness in her throat lasted for three hours. She went to sleep as the Benadryl caused her to be drowsy. When she awoke she had no symptoms. She then had a fever later in the day. she had no hives, lip swelling, tongue swelling, shortness of breath or presyncope associated with these symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PUB,levonorgestrel/ethin.estradiol (Portia 28) 0.15-0.03 mg Oral Tab,None,Migraine,,BACTRIM oral Ceftriaxone,"['Blood pressure abnormal', 'Cough', 'Pyrexia', 'Throat irritation']",UNK,MODERNA, 920815,KY,58.0,F,"Found deceased in her home, unknown cause, 6 days after vaccine.",Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PVT,unknown,unknown,"Per employee health records HTN, DM, Breast CA 2016 with radiation, obesity, gastric sleeve 10 years ago, arthritis, plantar fasciitis, ankle tendonitis, DeQuarvains, carpal tunnel, anxiety",,"Lisinpril, Codeine, Latex , environmental (hay fever)",['Death'],1,MODERNA,IM 920817,IL,51.0,F,"JOINT PAIN, BODY MALAISE, HEADACHE, SWOLLEN INJECTION SITE",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,SEN,"XARELTO, Hydrochlorothiazide",NONE,PULMONARY EDEMA,,NONE,"['Arthralgia', 'Headache', 'Injection site swelling', 'Malaise']",1,MODERNA,IM 920818,CA,35.0,M,A few moments after vaccination individual complained of throat numb and tingling and felt like it was swelling shut. Epinephrine was considered but condition resolved within about 20 minutes with no epinephrine given.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,unknown,unknown,unknown,,unknown,"['Pharyngeal hypoaesthesia', 'Pharyngeal paraesthesia', 'Pharyngeal swelling', 'Throat tightness']",1,MODERNA,IM 920819,OH,45.0,F,Pain and and severe weakness in arms and legs. Joint pain. Numbness in feet and hands. Increased blood pressure.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/26/2020,4.0,PVT,Had flu vaccines 12 days prior in same arm,,,,Latex,"['Arthralgia', 'Blood test', 'Hypoaesthesia', 'Muscular weakness']",UNK,MODERNA, 920820,NY,31.0,F,"About 12 hours after receiving the vaccine the resident developed temperature 101 F, headaches, vomiting and fatigue. Responded to Tylenol 1gm PO. Resident instructed to leave shift and go home to rest about 12 hours after that she was improved .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Fatigue', 'Headache', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 920821,FL,40.0,F,"Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then about 10 minutes later her Right arm became numb, then it returned to her lips on the Right side of her mouth, and then feeling wobbly, weakness on the Right leg. Elevated blood pressure, 182/112. Got medication prescribed and is lowerin blood pressure now, within an hour of taking medication, but numbness remains.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/05/2021,2.0,SEN,None,None,None,,None,"['Blood pressure increased', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Muscular weakness']",1,PFIZER\BIONTECH,IM 920823,TN,49.0,F,Woke up to an enlarged tongue - could not close mouth or eat,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/20/2020,1.0,PVT,,,,,bee stings,['Swollen tongue'],1,PFIZER\BIONTECH,IM 920824,HI,62.0,F,"Five minutes after vaccine patient had itchiness around eyes, itchy throat and mild shortness of breath. Later, patient reported swelling around eyes and lips.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,Shingrix,"Shingles vaccine, IV contrast, shellfish","['Dyspnoea', 'Eye pruritus', 'Lip swelling', 'Periorbital swelling', 'Throat irritation']",1,PFIZER\BIONTECH,IM 920825,CA,40.0,M,"Pins & needles/tingling sensation and numbness located throughout the body including the throat, mouth and tongue. Gradually diminished over 24 hours and has now resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,Lisinopril,None,Hypertension,,None,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia', 'Pharyngeal hypoaesthesia']",1,MODERNA,IM 920826,CA,39.0,M,"Weakness on the first day Diarrhea, weakness, chills, and weight loss the day after and ever since",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['Asthenia', 'Chills', 'Diarrhoea', 'Weight decreased']",1,PFIZER\BIONTECH,SYR 920827,KS,62.0,M,"Low fever, chills, 24 hrs. Headache Myalgia lasting 48 hrs. Arthralgia lasting 36 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Atorvastatin. Verapamil. Losartan,none,hypertension,,none,"['Arthralgia', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 920828,TN,36.0,F,The patient called stating she received the COVID vaccine yesterday at 11:30 AM. She reported that she had the usual sore arm. She woke up at 1:00 AM with 102.0 temperature and then start excessive vomiting at 1:30 AM. She also complained of vertigo and dizziness. She reports that she lost consciousness about 3:30 AM. Advised to go to the ER if symptoms continue.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PUB,Unknown,Unknown,Unknown,Patient stated that after receiving a flu vaccine she developed Bell's Palsy,NKA,"['Body temperature increased', 'Dizziness', 'Loss of consciousness', 'Pain in extremity', 'Vertigo', 'Vomiting']",1,MODERNA,IM 920830,NM,41.0,F,"20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP chest heavy face and nose itchy @ 3:15 pm Benadryl 25 mg IM + difficulty swallowing.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,OTH,"Clonazapam, Rizotiptan, Bacfofen, Wellbutrin , Adderal, Celexa, propranolol, Gabepetin.",,,,"mefoxin , Phenergan, trazadone, adhesive","['Chest discomfort', 'Dysphagia', 'Erythema', 'Hot flush', 'Hypertension', 'Pruritus']",UNK,PFIZER\BIONTECH,IM 920831,TX,64.0,F,"Severe muscle pain in neck, nausea, headache, fatigue, weakness, nerve pain which developed into shingles outbreak 5 days later, with continued malaise.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,Armour Thyroid Wixela 1 puff/daily Multi- vit/mineral,None.,Hypothyroid.,,Doryx antibiotic. Gluten & dairy sensitive.,"['Asthenia', 'Fatigue', 'Headache', 'Herpes zoster', 'Malaise', 'Myalgia', 'Nausea', 'Neck pain', 'Neuralgia']",1,MODERNA,IM 920832,NY,104.0,F,Vaccine 12/30/2020 Screening PCR done 12/31/2020 Symptoms 1/1/2021 COVID test result came back positive 1/2/2021 Deceased 1/4/2021,Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/01/2021,2.0,UNK,,,,,,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 920833,MI,44.0,M,"Severe arm pain, (9-10/10) with movement and loss of range of motion.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,Prilosec,none,none,,none,"['Mobility decreased', 'Pain', 'Pain in extremity']",UNK,MODERNA,IM 920834,NY,18.0,F,"Generalized flushing, increase body temp",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,"PCN, peanuts, pomegranate, strawberry","['Body temperature increased', 'Flushing']",1,MODERNA,IM 920835,TN,31.0,F,hot and cold sweats legs are really sore,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PHM,NONE,NONE,NONE,,NONE,"['Cold sweat', 'Hyperhidrosis', 'Pain in extremity']",1,MODERNA,SYR 920836,NY,35.0,F,"Estimated delivery date 05/09/2021. I had extreme fatigue and I had some trouble walking it flared my osteoarthritis. I decided to stay home and work from home since I was having trouble walking, the next day I felt fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,PVT,"Prenatal vitamins, 81mg of aspirin nightly",no,"asthma, migraines and osteoarthritis in the knee",,"iodine contrast solution causes anaphylaxis, seasonal allergies","['Fatigue', 'Gait disturbance', 'Osteoarthritis']",1,PFIZER\BIONTECH,SYR 920837,TX,53.0,F,"Delayed allergic reaction that included facial swelling, severe abdominal pain. Patient states she self medicated with Benadryl 50mg PO and is no longer symptomatic. PT instructed to speak with primary care physcian",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,WRK,,,Type I Diabetic,,Yes - PT states she had a previous severe allergic reaction but it is unknown to what she reacted to,"['Abdominal pain', 'Hypersensitivity', 'Swelling face']",UNK,MODERNA, 920838,,25.0,F,"since 12/31/2020 experiencing Dizzy, Lightheaded, Chest tightness, nausea, Diarrhea , dry mouth, dry throat, chills, swollen lymph nodes, symptoms progressing",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PVT,Vitamin C and elder berry viatamins,,,,NKA/NKDA,"['Chest discomfort', 'Chills', 'Diarrhoea', 'Dizziness', 'Dry mouth', 'Dry throat', 'Influenza virus test negative', 'Lymphadenopathy', 'Nausea', 'SARS-CoV-2 test negative', 'Streptococcus test negative']",1,MODERNA,IM 920839,MN,40.0,M,"Pleasant 40-year-old male comes in the emergency room with concern related to allergic reaction. Patient had received his COVID-19 vaccination approximate 60 minutes ago, at approximate 45 minutes after vaccination he developed flank pain left greater than right rated a 3 out of 10 extending down to his thighs he also noted a scratchy type sensation in the back of his throat feeling as if he needed to frequently clear his throat. The symptoms have been ongoing now for the past 15 to 30 minutes with no increasing or change in symptoms. Has never had allergic reaction in the past, unsure of previous Covid 19 infection though he describes in February of last year having upper respiratory illness which time he lost his sense of taste and smell. Currently denies any fevers, chills, nausea or vomiting. Denies any diarrhea. Denies cough or shortness of breath. Denies any swelling of the lips, face, eyes or nose. Denies any rash. Upon presentation emergency room patient was seen, evaluated, treated following standards of care given. Given patient's presenting symptoms and the recent COVID-19 vaccination will treat patient as adverse allergic reaction. Patient was given 50 mg of Benadryl IV, 20 mg of Pepcid IV, 10 mg of Zyrtec p.o. and 125 Solu-Medrol IV. Patient was observed in the emergency room for minimum of 2 hours, with complete resolution of symptoms. Patient was discharged home on Zyrtec to take 10 mg by mouth daily as well as Pepcid 20 mg by mouth twice daily for minimum of next 14 days, prednisone 20 mg 1 by mouth daily x5 days. Patient was given a prescription for EpiPen should his symptoms return or progress, recommend he call 911 and return immediately. Risks and warnings were discussed in detail, all questions were answered, patient verbalized understanding agreement plan of care.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,None,None,None,,None,"['Activated partial thromboplastin time normal', 'Alanine aminotransferase increased', 'Anion gap', 'Aspartate aminotransferase increased', 'Blood albumin', 'Blood alkaline phosphatase normal', 'Blood bilirubin normal', 'Blood calcium', 'Blood chloride normal', 'Blood creatine normal', 'Blood glucose increased', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea normal', 'C-reactive protein increased', 'Carbon dioxide normal', 'Flank pain', 'Glomerular filtration rate', 'Haematocrit normal', 'Haemoglobin normal', 'International normalised ratio decreased', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Platelet count normal', 'Protein total', 'Red blood cell count normal', 'Red blood cell sedimentation rate', 'Red cell distribution width normal', 'Throat irritation', 'White blood cell count normal']",UNK,PFIZER\BIONTECH, 920840,WA,62.0,F,"Severe headache from 12/30 0400 to 1/3/21, extreme fatigue, and excessive thirst",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,PVT,"Armour Thyroid, Estradiol",,Hypothyroidism,,Sulfa,"['Fatigue', 'Headache', 'Thirst']",1,PFIZER\BIONTECH,IM 920841,WA,43.0,F,Moderna EUA; moderate swelling and itching and pain lifting arm at injection site occured 7 days after injection. This swelling and pain is more severe than the initial reaction I had in the three days following the injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,PVT,,,asthma,,amoxicillin; mussells(maybe?),"['Injection site movement impairment', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 920842,ID,36.0,F,"I worked the night of 18th and 19th (night shift nurse) - night of 18th - arm very sore (dominant arm where shot was taken) by end of night arm was sore; continued for several days. (Got my period either the night of 18th or morning of 19th). About 36 hours after vaccine; stood up to attend an alarm and felt very ill at patient's bedside and had to sit down: nauseous (felt similar to co-vid) - took Motrin an hour later; the day of 20th - slept all day; 21st - no appetite; mild headache - nauseous - period at same time of vaccine; 22nd - felt bleh; didn't eat much food - period going away but I was feeling worse; feel like I have the return of internal vibrations (can sit in my hands when I'm trying to do something for a patient that needs done quickly) back in July when I had Co-Vid (when I was out of work out of month - and had to see a cardiologist - two months until normal (neural and cardiac symptoms that went away with time) - so was returning of buzzing/etc. 23rd: could feel like I had internal vibrations sensations; nauseous - increased - got a refill from an old dental prescription - started Zofran; headache pressure (head pressure); a vertigo-ish feeling - felt like I just walked off a boat; at that point - called out of work - COVID hotline hospital call - did a rapid test that was negative (on 24th) and on 24th: had still all the same symptoms - nausea was worse and felt a bit more dizzy occasionally and called out of work again but could take care of myself (laid around) - "" it felt like baby covid"" 25th - work wanted me to get tested again; 26th - Panther Co-vid test - which was also negative. 27th and 28th - dizziness better; still taking Zofran one time /day (for nausea); was able to go to work on 29th - still had some nausea but didn't have to lie down all day anymore - still had internal vibrations - feels like I should be having a tremor but can't see it externally; 30th finally able to see primary care Dr and she ordered lab work: Dr wasn't certain it was an adverse effect vs. me feeling my own immune response to spike protein; Initial covid symptoms in July were similar to this; and she will see how things go; SED Rate was 1 so not concerning; CBC was fine and B12 was fine. Not much as changed since then: returned to work; can go about things in every day; stopped taking Zofran on 31st; I still had nausea but it was mild enough that I didn't need to take it and Dr said it would be best to stop due to it's on effects. Yesterday, was first day with no nausea (1/4/2021); still have internal vibrations sensation but it has gone down quite a bit - now more of a mild buzzing electric current sensation - like insides are buzzing super fast ; when I noticed when not occupied with other things which is how it faded out with original illness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/22/2020,4.0,PVT,Aldactone - 50 mg daily every morning; metformin 1500 mg/ once a day; magnesium 250 mg daily; multi-vitamin; creatine - 5 grams a day;,nothing,PCOS - Poly cystic ovarian syndrome; chronic anemia; carrier of beta thalassemia,baby - reaction to TDap vaccine (the one before it) - said not to give to me again,dicloxacillin,"['Decreased appetite', 'Dizziness', 'Full blood count normal', 'Head discomfort', 'Headache', 'Hypersomnia', 'Hypophagia', 'Impaired work ability', 'Malaise', 'Nausea', 'Pain in extremity', 'Red blood cell sedimentation rate normal', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 test negative', 'Sensory disturbance', 'Vertigo', 'Vibratory sense increased', 'Vitamin B12 normal']",1,PFIZER\BIONTECH,IM 920843,NH,44.0,F,"7 days post vaccine enlarging erythematous, warm, tender circular skin lesion(6cm x 5 cm); reactive lymphadenopathy L axilla",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,None,None,Obesity,,"PCN, Sulfa, Cephalosporins...all cause rash","['Injection site erythema', 'Injection site warmth', 'Lymphadenopathy', 'Skin lesion']",UNK,MODERNA,IM 920845,TX,37.0,F,"pulling sensation on left arm to neck. took ibuprofen for discomfort. 1/4/21 began to get painful. feels a lump in neck area that has movement. sharp pain in neck, hurts to turn head. Rotating hot/cold presses to site. Using a topical cream Voltaren for pain on neck/arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,"Claritin, ibuprofen",,,,,"['Muscle tightness', 'Neck pain', 'Pain', 'Swelling']",1,MODERNA,IM 920847,OH,45.0,F,"?Moderna COVID- 19 Vaccine EUA? - Patient received Moderna vaccine 12/23/20, developed rigor and low grade temperature 99.8 degrees F, pain at injection site same day as injection. 12/27/2020 developed worst headache of life for 5-6 hours, vomiting, welts and hives on face, bruising of upper thighs, itching of legs. Patient considered going to emergency department due to severe headache and vomiting but improved after 5-6 hours. As of 1/5/2021, patient still has welts and hives on face and healing bruises on thighs, has been taking diphenhydramine with little improvement.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,,,,,"Shellfish, nuts, legumes (reaction lip swelling, throat tingling - no difficulty breathing or anaphylaxis)","['Chills', 'Contusion', 'Headache', 'Injection site pain', 'Pruritus', 'Pyrexia', 'Urticaria', 'Vomiting']",1,MODERNA,IM 920848,IL,40.0,F,"Fever of 100.8, body aches, and headache...this was after the first dose",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Advair 50/100,,Asthma,,,"['Headache', 'Pain', 'Pyrexia']",UNK,MODERNA, 920849,TN,48.0,F,"Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontinued. Proceeded to PCP office the following day due to face, neck and arm stiffness, edema in hands, legs, and face, continued metallic taste, and elevated BP (160/100). PCP prescribed oral steroids, antihistamine, and Epi-Pen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Blood pressure increased', 'Dysgeusia', 'Erythema', 'Face oedema', 'Musculoskeletal stiffness', 'Oedema peripheral', 'Skin warm']",1,PFIZER\BIONTECH,IM 920850,GA,28.0,F,"Chills, Body Aches, Temp 99.3, fatigue resolved within 48 hours from onset",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,"Topamax,BCP",migraine headaches,migraine headaches,,none,"['Body temperature increased', 'Chills', 'Fatigue', 'Pain']",1,PFIZER\BIONTECH,IM 920851,,49.0,M,"about 3 minutes after receiving vaccine, heart rate jumped to extremely high. Patient did not report until today so we were not able to get actual heart rate. This lasted for about 30 seconds, then went back to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,SEN,,,,,,['Heart rate increased'],1,PFIZER\BIONTECH,IM 920852,OK,64.0,F,"headache,nausea and vomiting ,chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,01/01/2021,14.0,WRK,"multi vitamin,vit d3,vit E","osteopenia ,occasional sinus headache",none,,tobrex,"['Chills', 'Headache', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 920853,,27.0,F,"mild numbness left side of face, starting day of vaccination; no f/u info available at this time. discussed with local health office.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,UNK,,,,,,['Hypoaesthesia'],UNK,MODERNA, 920854,NJ,47.0,F,"Hard painful lump post injection (day 1), itching and redness 7 days post injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PHM,"Lexapro 5 mg daily, Tumeric daily, vitamin d, calcium, b complex",None,Depression,,Erytrhomycin,"['Erythema', 'Induration', 'Mass', 'Pruritus']",1,MODERNA,IM 920855,,32.0,F,Clusters of cold sores around mouth and in nose after 3 years of not having any. I take a daily dosage of Valtrex (1gm).,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,UNK,Valtrex,,,,,['Oral herpes'],1,PFIZER\BIONTECH,SYR 920856,HI,45.0,M,Chills and fever for one night and pain at injection site for three days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,WRK,,,,,,"['Chills', 'Injection site pain', 'Pyrexia']",1,MODERNA,IM 920857,,31.0,F,"Patient came to our vaccination clinic to receive the COVID-19 vaccine and test. Administration was provided by LVN and patient was directed to our post-vaccination observation area to wait the 15 minutes. During those 15 minutes the patient became symptomatic and per the NP was having tachycardia, chest tightness and hypertension symptoms. NP made the decision to call EMS. EMS arrived at approximately 1515 and triaged patient, EMS then transported the patient to the ED. Husband was called and went with patient to the ED. Husband was escorted by security to ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,WRK,,,,,,"['Chest discomfort', 'Hypertension', 'Tachycardia']",UNK,PFIZER\BIONTECH, 920858,CA,34.0,F,"Developed numbness in left hand then subsequently, sharp burning pain in left upper chest, upper arm radiating to back. Also felt vertigo type symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,None,None,None,,None,"['Burning sensation', 'Chest pain', 'Hypoaesthesia', 'Pain', 'Pain in extremity', 'Vertigo']",1,MODERNA,IM 920859,CA,59.0,F,"As she was getting the shot, her upper back teeth had pressure throat started to burn 15 minutes after shot, she was losing her voice 4 hours later she started to wheeze fatigue headache hour later, she started getting hives on her right side of her forhead",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,UNK,,,,,,"['Dental discomfort', 'Dysphonia', 'Fatigue', 'Headache', 'Throat irritation', 'Urticaria', 'Wheezing']",1,MODERNA,SYR 920861,TX,39.0,F,Client experienced nausea and slight dizziness while walking to be seen by EMT 4 minutes after vaccine was administered. Client's symptoms stopped while with EMT. EMT checked cleared client with no issues. Client confirmed she was okay to go home. No medications were administered.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,No illnesses mentioned,none,,,"['Dizziness', 'Nausea']",1,MODERNA,IM 920862,SC,26.0,F,"headache, low grade fever,runny nose, loss taste and smell, feels flushed",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,PVT,"Vitamins,Claritin, Singular",none,Asthma,,caffeine,"['Ageusia', 'Anosmia', 'Flushing', 'Headache', 'Pyrexia', 'Rhinorrhoea']",1,PFIZER\BIONTECH,IM 920863,CA,53.0,F,"Arm has a huge redness around injection site. ""Not feeling well."" ""hot/cold sweats""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/04/2021,1.0,PVT,unknown,"unknown; ""recently recovered from COVID"", do not have exact timeframe",unknown,,unknown,"['Feeling of body temperature change', 'Hyperhidrosis', 'Injection site erythema', 'Malaise']",1,MODERNA,IM 920864,VA,43.0,F,"Moderna COVID-19 Vaccine EUA Headache, chills, body aches, fever, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PUB,none,none,None,,Quinolones,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 920865,NY,54.0,M,"On Jan 1 came down with fever, chills, aches and pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/01/2021,9.0,OTH,none,none,none,,none,"['Chills', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,SYR 920866,,27.0,F,"Got second shot in the morning: Last night 11:00pm started having fever 101, chill, bad headache. Took Tylenol. Today has a little headache, no fever, chills are better. Don't feel well enough to go to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Chills', 'Headache', 'Impaired work ability', 'Malaise', 'Pyrexia']",UNK,PFIZER\BIONTECH, 920867,TX,53.0,F,"fever, body aches, chills, headaches all for 48 hours starting on 12/31/2020",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Thrive energy pill, Xanax .5 mg, fish oil 2000mg, Co Q 10 100mg, Linzess 146mg,",none,IBS,,no,"['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,MODERNA, 920868,NY,69.0,M,"Tenderness around injection site, slight fatigue, slight chills, slight fever. No treatment other than sleep and rest. Symptoms disappear by Wednesday, 1/5/2021, a.m.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,PVT,"Vitamin B, C, D, Metformin, Aspirin, Losartan, Simvastatin",None,Diabetes,,Mussels,"['Chills', 'Fatigue', 'Injection site pain', 'Pyrexia']",1,MODERNA,IM 920869,NY,59.0,F,"mild flushing, elevated temp 99.2, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,rheumatoid arthritis,,Cipro,"['Body temperature increased', 'Flushing', 'Nausea']",1,MODERNA,IM 920870,ME,24.0,F,"At 2:08pm patient received dose #1 of Moderna COVID-19 vaccine. She began having lip tingling, lightheadedness and chest pounding at 2:10pm. On exam her BP was 126/82, HR 113, 95% O2 sat on RA. Patient was administered 50 mg of oral Benadryl at 2:17pm. She developed a rash on her chest and neck ? not hives. Lip tingling and chest pounding improved. Rescue arrived and upon discharge from the clinic to EMS her HR was 100, 99% O2 sat on RA. PMH significant for chronic urticaria and angioedema with 4 lifetime episodes of severe allergic reactions, but never to a vaccine. Had had epi administered x 2, last in 2016.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,Patient with history of anaphylaxis x2 - trigger unknown. Last epi-pen use 2016,"['Dizziness', 'Palpitations', 'Paraesthesia oral', 'Rash']",UNK,MODERNA, 920871,AL,40.0,F,Sinus pressure that could be felt in my teeth and headache began about 2 hours after vaccine. It has been almost a week and these sensations remain.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,None,Sinusitis and bronchitis one month prior,None,,Ceclor and eggs,"['Headache', 'Paranasal sinus discomfort', 'Sinus pain']",1,MODERNA,IM 920872,NJ,39.0,F,"Fever, chills, joint pain, headache, nausea, fatigue, bodyaches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,"Wellbutrin, Buspar",,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 920873,,44.0,F,Pt developed dizzyness - increased upon standing-postural changes . Drank water and observed for 40 minutes w/o improvementVS,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,,,,,,['Dizziness postural'],1,MODERNA,IM 920874,AZ,30.0,M,"12/18 VACCINATION 12/19 WOKE UP, HA, FATIGUE, MUSCLE ACHES. 12/20; HA WORSE, SYMPTOMS WORSE 12/21 FELT BETTER 12/22 VERTIGO, FACE IS RED. URGENT CARE. PRESCRIBED NAUSEA MEDS.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,OTH,MULTIVITAMIN; FISH OIL,,,FLU SHOT; SORE ARM,,"['Condition aggravated', 'Erythema', 'Fatigue', 'Headache', 'Myalgia', 'Vertigo']",1,PFIZER\BIONTECH,SYR 920875,TX,31.0,F,"Significant soreness in the arm where I received the injection, as well as a swollen lymph node in the underarm of the same arm. In addition, muscle aches, fatigue and chills. No fever recorded so far.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,"Phentermine 37.5 mg (for weight loss) , Aimovig 70 mg injection (for migraines)",I tested positive for COVID-19 on 12/1/2020.,Migraines,DPT shot as an infant. Shock like coma symptoms.,None,"['Chills', 'Fatigue', 'Lymphadenopathy', 'Myalgia', 'Pain in extremity']",1,MODERNA,IM 920876,TN,43.0,F,"Dizziness, nausea, light headedness, palpitations",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Dizziness', 'Nausea', 'Palpitations']",1,PFIZER\BIONTECH,IM 920877,MI,57.0,F,"Shortly after vaccination developed dizziness and nausea. Within 30 minutes had low blood pressure and pulse. Taken to ER. Also developed vomiting. Treated with epinephrine. Initially improved, then after 40 minutes heart rate dropped to low 40's and developed chest pain. Treated with 4 mg solumedrol, benadryl and more IV fluids. Slow recovery and observed over 5 hours. Went home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"propranolol, topamax",None,"Opthalmic migraine, hypercholesterolemia",,"erythromycin, vancomycin (both rash only)","['Chest pain', 'Dizziness', 'Electrocardiogram', 'Epinephrine', 'Heart rate decreased', 'Hypotension', 'Laboratory test', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 920878,MA,35.0,F,Sore arm Pregnant at time of administration,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"Prenatal, aspirin",,,sore arm,"Cats, seasonal allergies","['Exposure during pregnancy', 'Pain in extremity']",2,MODERNA,IM 920879,WI,36.0,F,"Abdominal pain that proceeded to get worse into the next day. Connected with PCP, had labs drawn and ultrasound ordered. Ended up going to ER. Determined to have Appendicitis, needed and had appendectomy on 12/29/2020.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/23/2020,12/28/2020,5.0,PVT,None,None,Back pain,,None,"['Abdominal pain', 'Appendicectomy', 'Appendicitis', 'Appendicolith', 'Computerised tomogram abdomen abnormal', 'Laboratory test', 'Ultrasound abdomen abnormal']",1,PFIZER\BIONTECH,IM 920880,WA,15.0,F,Patient vaccinated outside of age range for vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PUB,,,,,,['Product administered to patient of inappropriate age'],1,MODERNA,IM 920881,WA,32.0,F,"Around 10 am (2hrs post vaccination) I noticed some hives on my hands and dizziness. I also developed a mouth sore that later went away around 5pm. I drank 1.5 L of water and put some topical Benadryl cream on the hives, these symptoms resolved. At 8pm I began to get a temperature (temp max 101.2 around 11:17pm), a very sore swollen arm, massive headache, and myalgia/arthralgia in knees bilaterally. On 1/5 temperature has subsided to low grade (99.2F) but I still don?t feel well and have no sense of smell with a runny nose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,-woman?s multivitamin -vitamin d 5000 IU,-contracted COVID 19 on 12/16...had been cleared by my PA and hospital to receive vaccine despite this,"Hx exercise induced asthma, pre-eclampsia and placenta pr�via, hx retained placentas x 2 live births",,Allergic to Demerol,"['Arthralgia', 'Body temperature increased', 'Dizziness', 'Headache', 'Hyposmia', 'Malaise', 'Myalgia', 'Oral pain', 'Pain in extremity', 'Peripheral swelling', 'Rhinorrhoea', 'Urticaria']",1,MODERNA,IM 920882,MN,60.0,F,"Immediately after injection into patient's left deltoid, site swelling and felt firm. Some bruising noted. Ice applied and patient monitored for over 30 minutes. Patient did complain of scratchy throat while being monitored, but refused Benadryl at this time. Patient will notify her physician of this reaction to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Losartin for BP Omeprazole GI,None,Asthma Hypertension,,Sulfa drugs Erythromycin Vancomycin Chocolate Fish Dust Weeds,"['Injection site bruising', 'Injection site induration', 'Injection site swelling', 'Throat irritation']",1,PFIZER\BIONTECH,IM 920883,GA,54.0,F,Fatigue four days after vaccine. Shingles diagnosed one week after vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/01/2021,8.0,WRK,"Olemesartan, Cetrizine, VitaminB-12, Vitamin D3, Zinc , Iron",,"Cancer Survivor X 6 years, Low WBC as a result of radiation treatment. Otherwise very healthy.",,,"['Fatigue', 'Herpes zoster', 'Laboratory test', 'Physical examination']",1,MODERNA,IM 920884,KY,45.0,F,"Elevated heart rate, shortness of breath, fever (101.3), body aches, nausea, fatigue, impaired sleep - lasted 2 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Vitamin D, Biotin, Multi Vitamin, Airbourne supplement","COVID-19 diagnosis 12/7/21, able to return to work on 12/28, during illness fever (102.5) body aches, chills, decreased smell/taste, nausea, low appetite, elevated heart rate, short of breath, fatigue, poor sleep Went ED 12/16 with severe shortness of breath, heart rate up to 140's - treated with antibody regimen infusion.",none,,NKA,"['Dyspnoea', 'Fatigue', 'Heart rate increased', 'Insomnia', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 920885,GA,23.0,F,"Fever 101.0 F, dry cough,nasal congestion , recovered within 72 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/21/2020,2.0,PVT,Ibuprofen,none,none,,seasonal,"['Cough', 'Nasal congestion', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 920886,KY,58.0,F,"Rigorous chills x 3 hours, temperature up to 104.0 by mouth, increased arm tenderness (unable to lay on that side), malaise, body aches. All symptoms lasted approximately 14 hours and then resolved except for the arm soreness which resolved in 3 days. Treated fever with acetaminophen and Ibuprophen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,"Rosuvastatin, multi vitamin, phentermine",none,None,,Lortab,"['Body temperature increased', 'Chills', 'Malaise', 'Pain', 'Pain in extremity']",UNK,MODERNA,IM 920958,CA,51.0,F,"felt like she had a stroke; fell down; Pain in leg; itchiness in her head; left leg not functioning normally; This is a spontaneous report from a contactable nurse (reporting for herself). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), via an unspecified route of administration in the left deltoid on 21Dec2020 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. There were no prior vaccinations within 4 weeks prior to the first administration of the suspect vaccine. On 21Dec2020, the patient experienced left leg not functioning normally, which was reported with the seriousness criteria of disability. On 21Dec2020, the patient had itchiness in her head. The patient felt like she had a stroke, fell down and pain in leg on 22Dec2020, which were all reported with the seriousness criteria of disability. The patient called the doctor office and spoke with the doctor on call and was told to use diphenhydramine hydrochloride (BENADRYL). No further details provided. The patient was sent home for 10 days and she was sent back to work. The patient underwent lab tests and procedures which included COVID: negative in Dec2020. The outcome of the events was not recovered. The reported assessed the events related to the suspect product, BNT162B2.; Sender's Comments: The reported events leg dragging, leg pain and fall and suspected stroke were possibly related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, stroke was not diagnosed. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/21/2020,12/21/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Fall', 'Musculoskeletal disorder', 'Neurological symptom', 'Pain in extremity', 'Pruritus', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 920959,,,M,"Had a rapid test for COVID, and it was positive; Had a rapid test for COVID, and it was positive; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age started to receive BNT162B2 (lot number unknown), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist stated that they have vaccinated all their caregivers, and a physician (patient) who got the vaccine, called and reported to her that he had a rapid test for COVID, and it was positive. She is wondering if there was any data from the clinical trials where people tested positive after having the vaccine. The patient is now freaking out because he does not know if he needs to go to the hospital and get treatment for COVID. He works night shift and may have been exposed to COVID, but now she does not know how to guide him. The outcome of the events was unknown. The following information on the batch number has been requested.; Sender's Comments: The reported positive rapid test for COVID after COVID-19 immunization is considered related to the administration of BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 920960,TX,26.0,F,"Systemic pruritis (itching) all over body; COVID test type: Nasal Swab and Rapid Antigen and were both positive; COVID test type: Nasal Swab and Rapid Antigen and were both positive; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient started to receive BNT162B2 (lot number: EJ1685), intramuscular on 17Dec2020 16:30 at single dose in the left arm for COVID-19 immunization. Medical history included hypothyroidism from an unknown date. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and spironolactone. The patient previously took cefprozil (CEFZIL) and tapazole and both experienced allergies. The patient experienced systemic pruritis (itching) all over body on 22Dec2020 10:00. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has been tested for COVID-19. On 22Dec2020, the patient took COVID test type: Nasal Swab and Rapid Antigen and were both positive. No treatment received for the event ""Systemic pruritis (itching) all over body"". The outcome of the event ""Systemic pruritis (itching) all over body"" was not recovered. The outcome of the other events was unknown.; Sender's Comments: BNT162b2 provides protection against COVID-19 after 7 days from the second dose. This case does not match this codition",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/22/2020,5.0,PVT,SYNTHROID; SPIROLACTONE,,Medical History/Concurrent Conditions: Hypothyroidism,,,"['Pruritus', 'SARS-CoV-2 test positive', 'Viral test positive']",1,PFIZER\BIONTECH,OT 920961,CA,39.0,F,"result back w positive covid; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable nurse reporting for herself. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 19Dec2020 11:00 (at age 39 years old) as a single dose (Dose 1) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient was not administered any other vaccine in the 4 weeks prior to COVID-19 vaccination. Medical history was none. There were no allergies to medication, food, or other products. The patient's concomitant medications were not reported; however the patient had not received any other medications in the last 2 weeks. The patient experienced a sore throat, voice loss on day 4, loss of smell on day 5, went to test, and the result came back with positive COVID. The events resulted in a Doctor's office visit. The patient was tested post vaccination on 22Dec2020 via NAAT-PCR (nasal swab), with a positive result. The patient had not been diagnosed with COVID-19 prior to vaccination. There was no treatment received for the event(s). The clinical outcome of the event positive COVID was unknown The event was reported as non-serious. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The association between the event drug ineffective (COVID-19 infection) with BNT162b2 can not be fully excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/22/2020,3.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Anosmia', 'Aphonia', 'Oropharyngeal pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 920962,MA,42.0,F,"I had soreness; started with itching, redness and swelling at site of immunization.; started with itching, redness and swelling at site of immunization./5.0 cm area of redness and induration; 5.0 cm area of redness and induration at site; started with itching, redness and swelling at site of immunization.; This is a spontaneous report from a contactable physician (patient herself). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek5730, expiry date not reported), via an unspecified route of administration on the left arm on 17Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included food allergy, oral allergy, no anaphylaxis. Concomitant medications were not reported. On 26Dec2020 18:00, the patient started with itching, redness and swelling at site of immunization. Patient also had a 5.0 cm area of redness and induration at site. Patient also had soreness on an unspecified date but no other reaction. No therapeutic measure was taken as a result of the events. Clinical outcome of pain was unknown while for the other events was not recovered. Follow-up attempts are not possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/26/2020,9.0,PVT,,,Medical History/Concurrent Conditions: Food allergy; Oral allergy syndrome,,,"['Pain', 'Vaccination site erythema', 'Vaccination site induration', 'Vaccination site pruritus', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 920963,,,M,"Pain on the injection site; chill; nausea; lightheaded; This is a spontaneous report from a contactable physician via a Pfizer colleague. The Pfizer colleague received from a friend a video where the physician (also the patient) was interviewed on 25Dec2020 after getting the Pfizer/BioNtech vaccination and he reported the symptoms described below. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unkown, expiry date not reported), via an unspecified route of administration on the left arm on 24Dec2020 at a single dose for COVID-19 immunisation. Medical history was unknown. It was unknown if the patient was allergic to medication, food or other products and it was not known if the patient was diagnosed with COVID-19 before vaccination or if the patient had been tested for COVID-10 since the vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 24Dec2020, the patient experienced pain on the injection site (was still ongoing on 25Dec2020); also chill, nausea and lightheadedness which all disappeared 30 minutes after the injection. Clinical outcome of pain on the injection site was unknown, while for the other events was recovered on 24Dec2020. The batch/lot number was unknown as it was not available or not provided by the reporter at the time of report completion. Follow-up attempts are not possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: unknown,,,"['Chills', 'Dizziness', 'Nausea', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 920964,,,F,"tested positive for covid19/diagnosed with Covid; tested positive for covid19/diagnosed with Covid; she had SOB the day of her first vaccination; I am very sick; I feel bad; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of COVID-19 vaccine on Monday, 21Dec2020 and then was diagnosed with COVID-19 on 23Dec2020. Added that she was very sick and wondering if he'll get her second dose or not. The patient feel bad and is due for her second dose on 11Jan2021. The patient also reported that she had shortness of breath (SOB) the day of her first vaccination on 21Dec2020 and then tested positive for COVID-19 later. She posits she may have received the vaccine when she had an active COVID-19 infection. She is wondering if she can still get her second vaccination. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/01/2020,,UNK,,,,,,"['Dyspnoea', 'Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 920965,PA,58.0,F,"tested positive for COVID-19; headache; cough; voice being hoarse; Drug ineffective; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect from a Contactable nurse reporting for herself. A 58-years-old female patient received bnt162b2 (BNT162B2; Lot # EK5730) vaccine , via an unspecified route of administration on 18Dec2020 10:30 at single dose for covid-19 immunisation . Medical history included hypertension from an unknown date and blood cholesterol increased. Concomitant medication included losartan (LOSARTAN), hctz (HCTZ), ezetimibe (ZETIA), famotidine (PEPCID). The patient started having a headache and cough on 25Dec2020 and these symptoms worsened on 26Dec2020 in addition to her voice being hoarse. On 26Dec2020 she went to get tested at an urgent center and tested positive for Covid-19. The outcome of the event was not recovered.; Sender's Comments: The association between the event ""tested positive for COVID-19, headache, cough, and dysphonia"" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/25/2020,7.0,PVT,; HCTZ; ZETIA; PEPCID,,Medical History/Concurrent Conditions: High cholesterol; Hypertension,,,"['Cough', 'Dysphonia', 'Headache', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 920966,NY,51.0,F,"Approximately 15 small pencil point red bumps on arms and legs. Itchy. Not raised. Did not increase in size. Kept appearing within 5 days after the shot.; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EK5730 intramuscular in the left deltoid, from 22Dec2020 15:00 at a, single dose, for COVID-19 immunization. Patient received another Pfizer vaccine on the same date. Medical history included hypertension (HTN), guillain-barre syndrome from 2008. Patient's allergies included penicillin and ASA. Concomitant medication included paroxetine and amlodipine. On 23Dec2020 08:00, approximately 15 small pencil point res bumps on arms and legs. Itchy. Not raised. Did not increase in size. Kept appearing within 5 days after the shot. The outcome of events was recovered. no treatment or hospitalization was required. Follow-up attempts are completed. Information on the batch/lot number has been obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,PVT,;,,Medical History/Concurrent Conditions: Guillain-Barre syndrome (guillian barre); Hypertension; Penicillin allergy,,,['Rash papular'],1,PFIZER\BIONTECH,OT 920967,NY,65.0,F,"I had a temperature of 103.8; nauseated and dizzy; eyes hurting; headache; chills; tired; nauseated and dizzy; pain at the site; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 23Dec2020 at 10:30 as single dose for covid-19 immunization. Medical history included covid-19 from May2020. The patient's concomitant medications were not reported. The patient reported that "" I had a temperature of 103.8 "" on an unspecified date with outcome of unknown; pain at the site on 23Dec2020 with outcome of unknown; tired on 24Dec2020 with outcome of unknown; nauseated and dizzy on 24Dec2020 with outcome of unknown; chills on 24Dec2020 with outcome of unknown; eyes hurting on an unspecified date with outcome of unknown; headache on 24Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 101.8 Fahrenheit; temperature: 102.4 Fahrenheit; temperature: 101.3 Fahrenheit; temperature: 100.6 Fahrenheit; temperature: 99.2 Fahrenheit; temperature: 103.8 Fahrenheit on 24Dec2020; sars-cov-2 test: positive in May2020, sars-cov-2 test: negative in 23Dec2020. Therapeutic measures were taken as a result of "" I had a temperature of 103.8 "". Details were as follows: the nurse received the vaccine on a Wednesday 23Dec2020 at 10:30am. That night at her night shift, she had pain at the site. After midnight, the patient felt tiredness and felt like she had to lay down. At 6:00 she felt nauseated and dizzy. She had a temperature of 103.8. Thursday night, she went home at 7:10 and called her private doctor. The temperature was 101.8 and then it went down. The nurse had been administered the first of 2 dose series of Pfizer BioNTech COVID-19 Vaccine on 23Dec2020. She had received mandatory COVID-19 testing on 23Dec2020, prior to being administered the vaccine; she received the negative results of that COVID-19 testing on 25Dec2020. After being administered the vaccine she was monitored for 15 minutes and then went home. She was fine, had no allergy or anything. She reported that after she was administered the vaccine, she had pain, was really tired, nauseous, chills, high temperature, and her eyes hurting. She mentioned history of COVID-19 in May2020. She works as nightshift nurse at a rehab facility. She woke up that night of 23Dec2020 around 9:00pm-10:30pm and had onset of pain in right arm at injection site which she did not take too seriously because when you get a shot you get pain. Around midnight that night 24Dec2020, she went to work and had onset of being really tired like she just wanted to sit or lay down; she felt like she had to sit down and could not stand well. She continued working that shift on 24Dec2020 but kept getting so tired and had onset of chills and was supporting herself with her med cart. She drank a little sip of ginger tea she brought to work think maybe that would help her feel better. She felt that if she drank more ginger tea she would throw up because she felt nauseous. She was really busy at work 24Dec2020 so she did not check her temperature until after 6:00am which was 103.8 degrees Fahrenheit; and thought no wonder she feels like throwing up. She finished her shift at like 7:00am. For 2 days her temperature was turning high temperature so every 6 hours she was taking Motrin 2-200mg and that would make her temperature go down. Then temperature would go back up to like 102.4 degrees Fahrenheit, she would take ibuprofen (MOTRIN) again, temperature would come down to like 101.3 degrees Fahrenheit. She continued feeling nauseated, having chills, headache and feeling nauseous which she felt all of which could be related to the temperature. She reported to her employee health at work. She thinks it's better. Saturday morning of 26Dec2020, she woke up with temperature of 100.6 degrees Fahrenheit at 7:00am which was the first time her temperature had gown down like that so she did not take the ibuprofen. She checked it again later at like 1:00 pm and temperature was 101.8 degrees Fahrenheit so she took 2 Motrin again. After that her temperature did not go up like that anymore, it was like 99.2 degrees Fahrenheit. As soon as she came from work on 24Dec2020 she called her doctor's office and was seen by Nurse Practitioner who let her out of work for like 2 days. She reported her eyes also have been hurting, mostly her right eye is still hurting, the top is hurting like when you have a small pimple so she keeps checking but does not see anything with her eye. She couldn't even put a cold compress on for the temperature because of her headache and her eyes hurting. She could not even put cold compress to bring her temperature down. Seriousness criteria of all events was unknown. The patient has had no rash, no breathing problems, no coughing, no sore throat or other serious events. She was scared because she wondered if she had COVID-19 again with these events. She mentioned if people do not know these are side effects they would be scared, but she knows from the information she got with the Pfizer BioNTech COVID-19 Vaccine that these are normal for everyone. The only thing she wondered about is if the tiredness she is having is serious or not. She reported prior to getting the COVID-19 vaccine she tested positive for COVID-19 in May2020 and was very sick at that time because she works in a health field with COVID-19 patients. Pfizer BioNTech COVID-19 Vaccine. The patient indicated that she was fine before she got the vaccine; she had no cold, no coughing, no sore throat. The ibuprofen tablet was administered as 200 mg, 2 of the tablets at a time. : The outcome of all the events was unknown. The relatedness of the event, pain to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, really tired to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, nauseous to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, chills to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, high temperature to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, eyes hurting to the suspect drug was reported as related from the reporter using the assessment. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,PVT,,,Medical History/Concurrent Conditions: COVID-19,,,"['Body temperature', 'Body temperature increased', 'Chills', 'Dizziness', 'Eye pain', 'Fatigue', 'Headache', 'Nausea', 'SARS-CoV-2 test', 'Vaccination site pain']",UNK,PFIZER\BIONTECH,OT 920968,CT,30.0,F,"It looks like one of the ingredients may have an animal cell lipid; Syncope; Dizziness; feeling faint; like going to pass out now and then; overall achiness, severe headaches, fever; overall achiness, severe headaches, fever; overall achiness, severe headaches, fever; This is a spontaneous report from a contactable nurse reporting for herself. This A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EH9899), intramuscular at single dose in the left arm on 22Dec2020 09:00 for covid-19 immunisation. Medical history included reaction to pork, porsine and/or if she ever was exposed to exposed to heparin. There were no concomitant medications. On 23Dec2020, the patient experienced syncope (medically significant), dizziness (medically significant), feeling faint; like going to pass out now and then (medically significant), overall achiness, severe headaches, fever. The outcome of the events syncope, dizziness, feeling faint; like going to pass out now was recovering and outcome of overall achiness, severe headaches, fever was recovered on 24Dec2020. The patient ask: are there any animal products, pork gelatin or a lipid form of that contain in the vaccine? The events were described as follows: She experienced a significant amount of syncope and dizziness, for greater than 4 or 5 days post-receiving the vaccination. Also feeling faint like she is going to pass out every now and then. Has a more important question, wondering along with the doctors if one of the ingredients may have an animal product, like pork gelatin or a lipid form of that. It looks like one of the ingredients may have an animal cell lipid and was wondering if she was having a reaction to that. Declines to provide primary care provider details. States she received this first dose at occupational health in her workplace. Received the vaccine on the 22Dec2020 at 9am. 24 hours post vaccination, 1 day after, the syncope, dizziness, feeling faint started. Also the other symptoms, overall achiness, severe headaches, and fever were also experienced, but they stopped after that 24 hours. Those were expected since it was listed as side effects that popped up, so she expected those and they stopped after 24 hours. The syncope, dizziness, and faint feeling are not any worse and are very slowly improving, but she still has it and had to call out of work today because of it. That's consistent. Mentions it takes her a while to get down the stairs when getting product details for the COVID-19 vaccine. Unable to provide the vaccine NDC or expiry, or dose. Did not have any other vaccines at time of this one and none 4 weeks prior. Had to call a (company withheld) doctor and has to go to occupational health tomorrow to be seen. Declines having COVID virus. No further details provided.; Sender's Comments: Based on the compatible time association, the events syncope and dizziness are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Allergy to animal; Food allergy,,,"['Dizziness', 'Headache', 'Impaired work ability', 'Pain', 'Pyrexia', 'Syncope']",1,PFIZER\BIONTECH,OT 920969,MA,48.0,F,"chest got tight; Shortness of breath; throat was itchy, and felt like it closed; throat was itchy, and felt like it closed; This is a spontaneous report from a contactable other health care professional (HCP) (also reported as respiratory therapist) from a Pfizer Sponsored Program. A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 48-years-old at a single dose for COVID-19 immunization. Medical history included asthma from 2000 and ongoing (diagnosed 20 year ago). There were no concomitant medications. On 21Dec2020, the patient experienced: chest got tight (non-serious), shortness of breath (non-serious), throat was itchy, and felt like it closed. The clinical course was reported as follows: The caller was a respiratory therapist (also reported as health care professional (HCP)). The patient's first dose of the vaccine was on 21Dec2020 at the hospital where she works. Five hours after getting the vaccine, her chest got tight, she has shortness of breath, her throat was itchy, and she felt like it closed. The patient had asthma (diagnosed 20 years ago) and felt this reaction. It took 48 hours after the initial symptoms that she felt better. For treatment, the patient took her salbutamol (ALBUTEROL) inhaler and diphenhydramine hydrochloride (BENADRYL). The patient was scared to have the second dose; and she was going to talk to her primary care physician (PCP) about the second dose (but she did not think she would have much knowledge on what to do). The patient had a COVID PCR test the day she received the vaccine, and it was negative. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 21Dec2020. The clinical outcome of the events was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,,Asthma (diagnosed 20 years ago),,,,"['Chest discomfort', 'Dyspnoea', 'SARS-CoV-2 test', 'Throat irritation', 'Throat tightness']",UNK,PFIZER\BIONTECH, 920970,VA,51.0,M,"positive COVID-19 antigen test with symptoms (ache, cough, fever); positive COVID-19 antigen test with symptoms (ache, cough, fever); This is a spontaneous report from a contactable physician (patient). A 51-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration on 17Dec2020 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included borderline diabetes, ongoing hypertension, ongoing hyperlipidemia, ongoing rhinitis allergic, and currently ill. Concomitant medication included ongoing fexofenadine hydrochloride (ALLEGRA, strength: 180 mg) at 180mg once daily by mouth for Rhinitis allergic taking for years, ongoing lisinopril (strength: 40 mg) at 40 mg once daily by mouth for hypertension taking for two or three years, ongoing atorvastatin (strength: 40 mg) at 40 mg once daily by mouth for hyperlipidemia taking for a year. The patient experienced positive covid-19 antigen test with symptoms (ache, cough, fever) from 19Dec2020. Event details: The patient received the COVID 19 Vaccine on 17Dec2020 10:30AM in the left arm. Tested for COVID 19 with the antigen test, on 20Dec2020 and his result was positive, he experienced ache and cough on 19Dec2020. Clarified he started having symptoms in the evening (19Dec2020) and then tested in the morning (20Dec2020). He experienced the low grade fever on 20Dec2020. His maximum temperature was 100.4 fahrenheit. He had only been treated with over the counter products. No further information provided for the over the counter products. He was not hospitalized. He will take the second dose of the COVID 19 vaccine on 07Jan2021. The patient didn't have SARS-CoV2 antibodies at diagnosis. The patient was not admitted to an Intensive Care Unit. The patient didn't display clinical signs at rest indicative of severe systemic illness. The patient didn't require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient didn't have any pre-existing diseases worsened during the SARS-CoV2 infection. The patient was not treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The outcome of all his symptoms was resolving.; Sender's Comments: The reported events drug ineffective and COVID-19 are likely intercurrent and are unrelated to suspect drug BNT162B2 based on short temporal relation between vaccination and onset of events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/19/2020,2.0,PVT,ALLEGRA; ;,Hyperlipidemia; Hypertension; Rhinitis allergic,Medical History/Concurrent Conditions: Borderline diabetes; Illness,,,"['Cough', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 920971,FL,70.0,F,"sweats; Feeling of unwellness like she had the virus or bad flu; Feeling of unwellness like she had the virus or bad flu; could not hardly open eyes/eyes were very heavy; could not hardly open eyes/eyes were very heavy; chills; tiredness; headache; muscle pain; weakness; Joint pain; Fever; Injection site swelling and redness; Injection site swelling and redness; injection site pain; Nausea; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left upper arm, on 21Dec2020 (at the age of 70-years-old) at a single dose for COVID-19 immunization. Medical history included COVID-19 (lasted 3 weeks), high blood pressure (family history in mother and father), lumpectomy, breast cancer, radiation treatment, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, diabetes, obesity, fibroid tumors, fibroid tumors surgery, thyroid problem, bone density problem, and lower lobe left of lung piece cut out (not cancer). The patient previously received chemotherapy (MANUFACTURER UNKNOWN) for breast cancer, pethidine hydrochloride (DEMEROL) for post fibroid tumors surgery and experienced swollen hands and arms, influenza vaccine (MANUFACTURER UNKNOWN) in 2020 (usually gets swelling/red arm), and oxycodone hydrochloride;paracetamol (PERCOCET) and experienced feeling sick. Concomitant medications included unspecified medications for high blood pressure, thyroid problem, and bone density problem and unspecified nasal spray, water pill, and vitamins. The patient experienced could not hardly open eyes/eyes were very heavy, chills, tiredness, headache, muscle pain, weakness, joint pain, fever, injection site swelling and redness, injection site pain, nausea, sweats, and feeling of unwellness like she had the virus or bad flu on 22Dec2020. The clinical course was reported as follows: The patient felt fine the day when injection was given, but the next day, it was like she had COVID again. She had COVID 3 months ago and it lasted for 3 weeks. It was the same symptoms she had. She could not open her eyes hardly. They were very heavy. The patient had the chills, temperature, sweats, and injection site pain (the next day). There was also swelling and redness that remained for 6 days. The patient reported that if she still puts her hand on it now, there is some sensitivity. She also had tiredness and headache. The patient reported that she only had each of these symptoms for 24 hours (as reported) and the headache was gradually improved. The patient had muscle pain and weakness. She laid down and all she could do was sleep for 24 hours. The patient had nausea for 4 days. She did not have swollen lymph nodes. The patient underwent lab tests and procedures which included blood pressure: 120/80 on an unspecified date and bone density: unknown results on an unspecified date. The clinical outcome of could not hardly open eyes/eyes were very heavy, chills, tiredness, headache, muscle pain, weakness, joint pain, fever, sweats, and feeling of unwellness like she had the virus or bad flu was recovered on an unspecified date, nausea was recovered on 26Dec2020, and injection site swelling and redness and injection site pain was recovered on 28Dec2020. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,OTH,,,Medical History/Concurrent Conditions: Biopsy lung (not cancer); Blood pressure high (family history in mother and father); Bone density abnormal; Breast cancer (cancer free for 8 years); Chromosomal deletion; COVID-19 (lasted 3 weeks); Diabetes; Endocrine disorder; Fibroids; Fibroma removal; Lumpectomy; Obesity; Radiation therapy; Respiratory disorder; Thyroid disorder,,,"['Arthralgia', 'Asthenia', 'Asthenopia', 'Blood pressure measurement', 'Bone density abnormal', 'Chills', 'Eyelid function disorder', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Influenza like illness', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",UNK,PFIZER\BIONTECH, 920972,,,U,"positive COVID-19 rapid test with symptoms; positive COVID-19 rapid test with symptoms; headache; nasal congestion; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced positive COVID-19 rapid test with symptoms, headache and nasal congestion on an unspecified date. The patient developed headache and nasal congestion by the third day after the vaccination. The patient underwent lab tests and procedures which included COVID-19 rapid test: positive on an unspecified date. The clinical outcome of positive COVID-19 rapid test with symptoms, headache and nasal congestion was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: The reported positive COVID-19 rapid test with symptoms after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Headache', 'Nasal congestion', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 920973,PA,37.0,F,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received their first dose of BNT162B2 (lot number: EL0140; expiry date unknown), intramuscular on 21Dec2020 at single dose for COVID-19 immunization. Medical history included congestion and dry cough (before vaccination), and not tasting anything from an unknown date. Concomitant medication included vitamins. The patient reported that they just have the concern about the vaccination last Monday that was 21Dec2020, on 25Dec2020, Christmas day they were diagnosed with Covid. They were thinking because the day before their vaccination they already had like some kind of congestion and also some kind of dry cough but they didn't really think that it was Covid but they were still able to get the vaccination on Monday. When they started to feel like they were not tasting anything, that's when they decided to get tested and it turns out to be positive. They were confirmed positive on the 25th but in their mind they were probably having Covid since the day before they got they vaccination. So their worry is, is there any effect where they got the vaccine where they already have the Covid in their body. So that is really their worry right now. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 25Dec2020. The outcome of the events was unknown.; Sender's Comments: The association between the event drug ineffective (COVID-19) with BNT162b2 can not be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/25/2020,4.0,UNK,,,Medical History/Concurrent Conditions: Congestion nasal; Dry cough; Loss of taste,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 920974,,43.0,F,"developed rashes on the chest area, not spreading; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK5730), via an unspecified route of administration into the left deltoid on 18Dec2020 as the first single dose for covid-19 immunization. Medical history was reported as none. Concomitant medication included rosuvastatin calcium (CRESTOR). The patient developed rashes on the chest area, not spreading on 22Dec2020. The event as reported between not serious and medically significant by the reporter. Details were as follows: and patient was a nurse that had her vaccine through her workplace on 18Dec2020, so she was 10 days out, and noticed a rash on her chest on day 4, which was still present. It did not seem to be spreading, and she could not think of any reason for the reaction. She was scheduled to receive the second dose in three weeks. The outcome of developed rashes on the chest area, not spreading was not recovered. The relatedness of the event to the suspect drug was reported as unknown from the reporter.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of rash. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/22/2020,4.0,UNK,CRESTOR,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Rash'],1,PFIZER\BIONTECH, 920975,OK,53.0,F,"blurred vision; little spots on the inside of her eyelids; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot number and expiry date were unknown), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. Medical history included eyeglasses wearer (reported as with her glasses). The patient's concomitant medications were not reported. The patient is experiencing symptoms from the COVID-19 vaccine received on 18Dec2020. She began to have blurred vision that night, and it worsened over the following weekend. She saw the eye doctor on 22Dec2020, and they stated her vision had changed even with her glasses. Now she has little spots on the inside of her eyelids that were also noticed on the eye examination in Dec2020. She has already reported these symptoms to the V-safe program. She mentioned that she is not the only nurse in the workplace that has experienced blurry vision. She asked if she should receive the second dose on 08Jan2021. It was still blurry, but it was better than it was a week ago. It still affected her reading and seeing at a distance. It scared her to get the second one because she doesn't want to go blind. She went to the eye doctor for visit on Tuesday. The outcome of the event blurred vision was recovering, while for the other event was unknown. The reporter considered blurred vision as serious due to being medically significant. Information about lot/batch number has been requested.; Sender's Comments: There is not a reasonable possibility that the reported event vision blurred and eyelid disorder related to the suspect product event most likely due to patient underlying contributory factors",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: Eyeglasses wearer,,,"['Eyelid disorder', 'Ophthalmological examination abnormal', 'Vision blurred', 'Visual impairment']",1,PFIZER\BIONTECH, 920976,AL,,U,"positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced positive COVID-19 test on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The clinical outcome of positive COVID-19 test was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: The reported positive COVID-19 test after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PVT,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 920977,IN,32.0,M,"body aches; headache; congestion; This is a spontaneous report from a contactable physician (patient). A 32-years-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at a single dose for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The doctor (HCP) received his 1st vaccination on 18Dec2020. He started having symptoms on 26Dec2020. These symptoms are ""body aches, headache and congestion."" Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/26/2020,8.0,UNK,,,,,,"['Headache', 'Nasal congestion', 'Pain']",1,PFIZER\BIONTECH, 920978,GA,41.0,F,"very sick; chills; fever; diarrhea; vomiting; This is a spontaneous report from a contactable other hcp. A 41-year-old female patient received bnt162b2 (lot number: EH9899), intramuscularly at arm left, first dose on 22Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient got the vaccination yesterday (22Dec2020) and she has been very sick, chills, fever, diarrhea and vomiting. Didn't come to work today and she claims is getting worse. The event was unwitnessed by staff and the reported by client employer. Age at vaccination is 41 years old. Adverse event started on 23Dec2020. The event was reported as non-serious. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Body temperature', 'Chills', 'Diarrhoea', 'Illness', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,OT 920979,,,F,"having symptoms/She tested positive to COVID-19; having symptoms/She tested positive to COVID-19; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient started having symptoms on Thursday. On Friday, her supervisor had her get tested for COVID. She tested positive to COVID-19 in Dec2020. Outcome of the events was unknown. The patient wanted to know if she is symptom free, should/can she still get the 2nd dose as planned. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the single dose and short duration",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/01/2020,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 920980,NJ,36.0,F,"single hive on abdomen (itchy)/full body hives and itching; single hive on abdomen (itchy)/full body hives and itching; This is a spontaneous report from a contactable Physician. A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140, expiry date unknown) intramuscular at left arm on 24Dec2020 at single dose for Covid-19 immunization in a hospital facility. Medical history included Anxiety, Hypertension, and GERD (gastrooesophageal reflux disease). The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) on 08Dec2020 for immunization; bupropion hydrochloride (WELLBUTRIN), amlodipine, omeprazole; from unspecified date for unspecified indication. On 25Dec2020, the patient developed a single hive on abdomen (itchy), and on 26Dec2020 the patient developed full body hives and itching but spared the face and mucosal surfaces. The patient has no swelling, no respiratory symptoms. The patient has not been tested for Covid-19 since the vaccination. The patient received treatment of antihistamines (steroids if no improvement) on unspecified date. The hives responded to antihistamines temporarily. The outcome of the event single hive on abdomen (itchy)/full body hives and itching was not recovered. The reporter considered the events non-serious; did not results in death, was not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, not a congenital anomaly/birth defect.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event hives and itching due to temporal association.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,PVT,WELLBUTRIN; ;,,Medical History/Concurrent Conditions: Anxiety; GERD; Hypertension,,,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,OT 920981,AR,,F,"ended up testing positive for COVID virus after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine/ She had symptoms; ended up testing positive for COVID virus after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine/ She had symptoms; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is 1st of two reports. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899; expiry date unknown), via an unspecified route of administration, on an unspecified date, at 0.3 mL, single for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The nurse reported on an unspecified date that the patient tested positive after the first dose. The reporter works in employee health at their hospital. The employee ended up testing positive for COVID virus after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine. She had symptoms the first 2-3 days after getting the vaccine and assumed it was a normal immune response, but after that she continued to have the symptoms. They went to see the provider and tested positive for COVID virus. They were asking how to handle their second doses. Outcome of the events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the short duration of less than 5 days since the vaccine first dose is given.,Linked Report(s) : US-PFIZER INC-2020516628 same reporter, same drug, same event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 920982,TX,60.0,F,"nausea/waves of nausea; lower abdominal pain; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2; reported as COVID19 Vaccine; lot number: EJ1685; expiration date: Mar2021), via an unspecified route of administration right arm on 18Dec2020 15:00 at single dose for Covid-19 vaccination. Medical history included IBS (irritable bowel syndrome), hysterectomy at age 42 and she doesn't have periods (amenorrhea). The patient family medical history included her family are all dead and has been for a long time. The patient's concomitant medications were not reported. It was reported that vaccinations within 4 weeks included shingles vaccination 5 weeks before covid-19 vaccine wherein the patient first singles shot was fine. Her second shingles shot made her sick, body aches, and fever for about 24 hours. She received it from a pharmacy inside a store. The reporter mentioned that she took her first covid vaccine shot and was able to experience nausea, headache lower abdominal pain. She inquired if there was information on until when she will be experiencing this or how long the symptoms will last. She mentioned that she had headaches and waves of nausea, and before nausea, she had lower abdominal pain. She doesn't know if abdominal pain was coincidental. She had a hysterectomy, so she doesn't have periods. She lives with IBS, but this abdominal pain was different. Immediately after COVID-19 Vaccine within about 20 minutes after injection (18Dec2020 15:20), she had headaches and she still has been having headaches. She had strange lower abdominal pain that lasted a minute and a half then shortly after that started having waves of nausea. She added that the waves of nausea began 24 hours after the COVID-19 Vaccine (19Dec2020 15:00). The outcome of the event headache was not recovered, as for nausea was unknown while the outcome of the other event was recovered on Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Amenorrhea; Death of relative; Hysterectomy (at age 42); Irritable bowel syndrome (Verbatim: IBS),,,"['Abdominal pain lower', 'Headache', 'Nausea']",1,PFIZER\BIONTECH, 920983,AK,56.0,F,"Sore left arm 2-3 days after vaccinated; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot: EK5730, via an unspecified route of administration, in the left arm, from 22Dec2020 09:15 at a single dose for COVID-19 immunization. Medical history included allergies to penicillin, gluten, chicken eggs (whites & yolks) and cow's milk. Patient was not pregnant. The patient's concomitant medications were not reported. on 23Dec2020 09:00, after being vaccinated, the patient experienced sore left arm for 2-3 days. The patient underwent lab tests and procedure on unspecified date which included Nasal Swab test/COVID test, yielding negative result. The outcome of event was recovered on Dec2020. Follow-up attempts are completed. Information on the batch/lot number has been obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Food allergy; Gluten sensitivity; Penicillin allergy,,,"['Pain in extremity', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 920984,NV,,F,"lost sense of smell; cold like symptoms; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced cold like symptoms on 24Dec2020. Then on the 26th (26Dec2020), patient lost sense of smell. Outcome of events was unknown. Follow-up attempts are completed. The following information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/24/2020,1.0,UNK,,,,,,"['Anosmia', 'Nasopharyngitis']",UNK,PFIZER\BIONTECH, 920985,,,U,"a patient received Pfizer COVID-19 vaccine, couple of days later the patient tested positive for COVID-19; a patient received Pfizer COVID-19 vaccine, couple of days later the patient tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) via an unspecified route of administration on an unspecified date at a single dose as Pfizer COVID-19 vaccine. Medical history and concomitant medications were not reported. It was reported that on an unspecified date, a patient received Pfizer COVID-19 vaccine, couple of days later the patient tested positive for COVID-19, patient subsequently received monoclonal antibody treatment: a combination of Casirivimab and Imdevimab. It was inquired if the patient could receive the second dose of COVID-19 vaccine. The outcome of the events was unknown. Information about Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of LOE and COVID 19. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information. Based on the information provided in the case, this individual report would not seem to modify the risk-benefit profile of the subject product.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 920986,,,U,"I took the vaccine and two days after I tested positive/had lost my sense of smell and taste; I took the vaccine and two days after I tested positive/had lost my sense of smell and taste; Lost my sense of smell and taste; Lost my sense of smell and taste; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer stated that he/she just got the vaccine on Wednesday (23Dec2020), and he/she started experiencing some symptoms on 24Dec2020 where he/she had lost his/her sense of smell and taste. On 25Dec2020, he/she went 'health' to get tested, and he/she tested positive. The consumer is asking whether this has been reported that one of the side effects of getting the vaccine. The consumer said he/she hasn't read anything about loss of taste and smell after taking the vaccine. He/she was wondering if this has been reported or this is one of those small side effects that the vaccine has. The consumer further stated that he/she took the vaccine and two days after, he/she tested positive. Now, his/her whole family is also positive but only his/herself had the vaccine, because he/she is the only one that works in healthcare (further clarification was unknown, hence reporter was captured as consumer). The outcome of the events was unknown. No follow-up attempts are possible; Information about lot/batch number could not be obtained. No further information is expected.; Sender's Comments: The association between the event lack of effect (COVID19, lost of taste and smell) with BNT162b2 can not completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/24/2020,1.0,UNK,,,,,,"['Ageusia', 'Anosmia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 920987,AR,,U,"ended up testing positive for COVID virus after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine/had symptoms; ended up testing positive for COVID virus after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine/had symptoms; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the 2nd of two reports. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, strength: 0.3 mL, lot number: EH9899; expiry date was unknown), via an unspecified route of administration on an unspecified date at 0.3 mL, single for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient ended up testing positive for COVID virus after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine. The patient had symptoms the first 2-3 days after getting the vaccine and assumed it was a normal immune response, but after that the patient continued to have the symptoms. The patient went to see the provider and tested positive for COVID virus. The patient was asking how to handle his/her second dose. The outcome of the event was unknown.; Sender's Comments: Based on the information currently provided, the company considers that a causal relationship between the COVID-19 and vaccination with BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-2020516297 same reporter, same event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 920988,CA,44.0,F,"stiffness; Spreading from my shoulder up my neck to the base of my skull/worsening pain; Limited ROM; Horrific pain upon turning my neck towards the left; Woke up the following morning with a kink in my left neck; This is a spontaneous report from a contactable nurse, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ECT1685), via an unspecified route of administration in the left arm on 23Dec2020 at 13:15 (at the age of 44-years-old) as a single dose for COVID-19 immunization. Medical history included anxiety, depression, hypothyroidism, lumbar fusion, and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), colecalciferol (VIT D3), and alprazolam (XANAX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 09:00, the patient woke up the following morning with a kink in her left neck, which was similar to sleeping awkwardly. She applied some heat and took some ibuprofen (ADVIL). It persisted on 25Dec2020 and she did the same treatment. On 26Dec2020, the pain was exponentially worse and spreading from her shoulder up her neck to the base of her skull. She had limited range of motion. She had horrific pain upon turning her neck towards the left. She went to the emergency room on 27Dec2020 and 28Dec2020 due to the worsening pain, stiffness, and loss of function. The patient was treated with ibuprofen and unspecified muscle relaxers. The patient had not been tested for COVID-19 post vaccination. The clinical outcomes of the kink in her neck, neck pain, limited range of motion, worsening pain, and stiffness, were not recovered. The events were all reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,ZOLOFT; VIT D3; XANAX,,Medical History/Concurrent Conditions: Anxiety; Depression; Hypothyroidism; Penicillin allergy; Spinal fusion,,,"['Joint range of motion decreased', 'Musculoskeletal stiffness', 'Neck injury', 'Neck pain', 'Pain']",1,PFIZER\BIONTECH, 920989,CA,,F,"tested positive after receiving Covid-19 vaccine; tested positive after receiving Covid-19 vaccine; This is a spontaneous report from a contactable nurse. A 38-years-old female patient started received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 18Dec2020 at a single dose for prevention of Covid 19. The patient medical history and concomitant medications were not reported. The nurse reported that a staff member received the first dose of Covid-19 vaccine on 18Dec2020. Approximately 9 days later, on 27Dec2020, the patient developed/experienced tested positive after receiving Covid-19 vaccine. The seriousness criteria for this event was none. The nurse asked if the patient will be able to receive the second dose and what is the advice for the patient. The outcome of the event was unknown. The reporter considered the relationship of the event to treatment with BNT162B2 as not applicable. Information about lot/batch number was requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event tested positive Covid-19 based on the known safety profile. However the short duration of 9 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/27/2020,9.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 920990,OK,58.0,F,"Flush; Itching; felt like she was going to wet herself; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730 and Expiration Date: unknown), intramuscularly in the upper left arm on 22Dec2020 at 08:48 at 58-years-old at a single dose for COVID-19 immunization; which was received at a hospital. The patient stated the hospital had a line for employees to drive up and receive the vaccine, she was in her car when the vaccine was administered. Medical history included ongoing allergy to sulfates from an unknown date (diagnosed at least 20 years ago). The patient had an allergy to sulfates. The patient had a bad reaction to sulfamethoxazole and trimethoprim (BACTRIM) many years ago. The patient did not have the Lot and NDC numbers, or expiration date to provide. The patient stated the reaction was so bad she had to receive multiple injections because her throat was closing off and she had big hives. This occurred years ago. There were no concomitant medications. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced bad reaction, throat was closing off and big hives from an unknown date to an unknown date. On 22Dec2020, the patient experienced: flush, itching, and felt like she was going to wet herself; all assessed as non-serious. The patient called about the COVID-19 vaccine. The patient was wondering if there was any sulfa in the vaccine. The patient had the vaccine on 22Dec2020, and she was fine for the first hour and then she became flush and started itching an hour later. The patient stated "" you know when you get a CT scan and the contrast makes you feel warm down there"", states she got that same feeling where she felt flush and where she was warm down there and she felt like she was going to wet herself. The patient stated, ""the bladder feeling came on so harsh and fast."" The patient took diphenhydramine hydrochloride (BENADRYL) for two days and she felt better. The patient later clarified that she recovered completely as of 25Dec2020. Therapeutic measures were taken as a result of flush and itching. The clinical outcome of the events, flush and itching, was recovered on 22Dec2020. The clinical outcome of the event, felt like she was going to wet herself, was unknown. There was no history of previous immunization with the Pfizer vaccine considered as a suspect. There were no additional vaccines administered on the same date of the Pfizer suspect. The events did not require a visit to an emergency room or physician office. The patient did not receive any prior vaccinations within 4 weeks of the suspect vaccine. There were no adverse events (AEs) following prior vaccinations. There were no relevant tests performed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,,Allergy to chemicals (diagnosed at least 20 years ago),,,,"['Flushing', 'Pruritus', 'Urge incontinence']",UNK,PFIZER\BIONTECH,OT 920991,NY,51.0,F,Patient had GI distress (N/V/diarrhea) on 12/25,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,12/25/2020,1.0,PVT,,,,,,"['Abdominal discomfort', 'Diarrhoea', 'Nausea', 'Vomiting']",UNK,MODERNA,IM 920992,CA,51.0,F,"lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; swelling in face; swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 28Dec2020 03:30 PM at single dose (lot number: EH9899) for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products. Concomitant medications include Estradiol received in two weeks. No other vaccine in four weeks. The patient was not pregnant. The patient experienced lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here that resembled sunburn, but was not painful; on 28Dec2020 04:00 PM. The patient took antihistamine (Claritin) and rest as treatment. All events were reported as non-serious. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PUB,,,Medical History/Concurrent Conditions: Allergy; Asthma,,,"['Chills', 'Dizziness', 'Heart rate', 'Heart rate increased', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Lip swelling', 'Paraesthesia', 'Paraesthesia oral', 'Rash', 'Swelling face']",1,PFIZER\BIONTECH, 920993,VA,42.0,F,"had loss of sense of smell and tested positive for the virus; had loss of sense of smell and tested positive for the virus; This is a spontaneous report from a contactable healthcare professional (patient). A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular on 17Dec2020 at a single dose on the left arm, for Covid-19 immunization. The patient has no medical history and no concomitant medications (no other vaccines in four weeks and no other medications in two weeks prior to vaccination). The patient has no known allergies to medications, food, or other products. The patient had loss of sense of smell, no other symptoms on 25Dec2020 and tested positive for the virus yesterday, on 27Dec2020. The patient has no Covid-19 prior to vaccination. The patient underwent Covid test (Nasal Swab) and result was positive on 27Dec2020. The patient did not receive any treatment for the event. Outcome of the event was unknown. The events were assessed as non-serious by the reporter. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: A possible contributory role of BNT162B2 vaccine cannot be excluded for event based on available information.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/25/2020,8.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Anosmia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 920994,AL,55.0,F,"PATIENT VACCINATED AROUND 9AM. SHE REPORTS SHE FELT WARM/FLUSHING, FAINT AND STOMACH SPASMS WITHIN ABOUT 4-5 MINS. SHE FELT BETTER AND GOT UP TO WALK ABOUT 30 MINS LATER. SYMPTOMS WORSENED AFTER WALKING ~9:45AM: FAINT AGAIN, SEVERE RETCHING, BP196/140 TO 199/164, TROUBLE SWALLOWING, SOB, WHEEZING. AT 9:58AM, EPI PEN 0.3MG ADMINISTERED AND EMS ACTIVATED. SYMPTOMS REPORTED IMPROVED FOLLOWING EPI. EMS ARRIVED 10:05AM. PATIENT REPORTED RECEIVING 2 BAGS OF PEPCID, STEROIDS, AND ZOFRAN AT HOSPITAL. WAS RELEASED BETWEEN 11:30AM-12PM ON 1/4/21, BP 140/90 AND ACUTE SYMPTOMS RESOLVED. FOLLOW UP WITH PATIENT 1/5/21: NO PRIOR HX OF HTN, BP 120/60, NO SOB/ BREATHING DIFFICULTY. C/O SEVERE HEADACHE, LOW TEMP, FATIGUE, MUSCLE ACHES, SORE THROAT.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,"EFFEXOR 75MG QD, LIPITOR 80MG QD, FENOFIBRATE 150MG QD, ASA 81MG QD, QUERCETIN 1200MG QD, ZINC 50MG QD, VIT C 1000MG QD,",,"CEREBROVASCULAR DISEASE, ANEURYSMS- STENT AND REPAIR, DEPRESSION, HYPERCHOLESTEROLEMIA, HYPERTRIGLYCERIDEMIA",,PENICILLIN-AUGMENTIN (ANAPHYLAXIS/HOSPITALIZED),"['Abdominal pain upper', 'Body temperature decreased', 'Dizziness', 'Dysphagia', 'Dyspnoea', 'Fatigue', 'Feeling hot', 'Flushing', 'Headache', 'Myalgia', 'Oropharyngeal pain', 'Retching', 'Wheezing']",1,PFIZER\BIONTECH,IM 920995,MO,28.0,F,"Fever (99.6); Arm soreness; Headache; Fatigue; This is a spontaneous report from a contactable physician (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), intramuscularly in the left arm, on 21Dec2020 at 07:15 (at the age of 28-years-old) at a single dose for COVID-19 immunization. Medical history included migraines and allergies to mango. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included magnesium (MANUFACTURER UNKNOWN) taken as supplement. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever (99.6), arm soreness, headache, and fatigue on 21Dec2020 at 20:00. The events were reported as non-serious. The patient underwent lab tests and procedures, which included body temperature: 99.6 on 21Dec2020. No therapeutic measures were taken as a result of the events. The clinical outcome of fever (99.6), arm soreness, headache, and fatigue was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Fruit allergy; Migraine,,,"['Body temperature', 'Fatigue', 'Headache', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,OT 920996,HI,52.0,F,"Droopy left cheek.; This is a spontaneous report from a contactable nurse. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685), intramuscularly in the left arm, on 17Dec2020 at 14:30 (at the age of 52-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient had no other medications within two weeks of vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took sulfamethoxazole, trimethoprim (SEPTRA) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced droopy left cheek on 21Dec2020. No therapeutic measures were taken as a result of the event. The clinical outcome of droopy left cheek was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of droopy left cheek might not be excluded considering the plausible temporal relationship. The patient had previous allergy reaction to antibiotic (sulfamethoxazole, trimethoprim) use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/21/2020,4.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Facial paralysis'],1,PFIZER\BIONTECH,OT 920997,NM,51.0,F,"Sat 12-19-20 red spot around injection site, Mon 12/21/20 it feels warm and itching the redness is larger PT states she has taken Benadryl for symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/17/2020,0.0,OTH,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",UNK,PFIZER\BIONTECH, 920998,HI,43.0,M,"Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; This is a spontaneous report from a contactable Nurse. A 43-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284), intramuscularly on 23Dec2020 08:30 at single dose on Left arm for immunisation. The most recent COVID-19 vaccine was administered at Hospital. Medical history was none. No other vaccine in four weeks and two weeks. No covid prior vaccination. The patient's concomitant medications were not reported. The patient experienced tiredness, chills, body aches, diarrhea, persistent fevers even with tylenol or motrin taken 99.5-101.5degf on 23Dec2020 16:00. AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment for tiredness, chills, body aches, diarrhea. The outcome was not recovered. Covid test post vaccination included Covid 19 with type of Nasal Swab on 27Dec2020 with unknown results.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'Chills', 'Diarrhoea', 'Fatigue', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 920999,MD,42.0,F,"itching immediately after injection; then burning; then redness traveling up arm into chest; immediate onset of diarrhea; This is a spontaneous report from a contactable nurse(patient). A 42-year-old female non-pregnant patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=el0140), intramuscular on 26Dec2020 09:30 at left arm at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient had no known allergies and no other medical history. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient experienced itching immediately after injection, then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. Adverse event start date was 26Dec2020 09:30 AM. The events result in emergency room/department or urgent care. Treatment of Pepcid, Benadryl and prednisone received. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: no,,,"['Burning sensation', 'Diarrhoea', 'Erythema', 'Pruritus']",1,PFIZER\BIONTECH,OT 921000,CA,29.0,F,"patient tested positive for COVID; patient tested positive for COVID; This is a spontaneous report from a contactable physician from a Pfizer-sponsored program Pfizer First Connect. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 17Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Dec2020, the patient tested positive for COVID. The clinical outcome of patient tested positive for COVID was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events Drug ineffective and COVID 19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/27/2020,10.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 921001,NC,58.0,M,"large bruising and redness, localized - delayed reaction",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/31/2020,9.0,OTH,,none,none,,NKDA,"['Contusion', 'Erythema', 'Skin reaction']",1,MODERNA,IM 921002,IN,34.0,F,"Nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists.; Nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists.; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK5730), via an unspecified route of administration on the right arm on 18Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included Gyn issues, migraine and headaches but otherwise healthy. The patient also had allergies with sulfa, leminine, and latex sensitivity but not anaphylactic. Concomitant medications included elagolix sodium (ORILISSA), and calcium carbonate, colecalciferol, phytomenadione (VIACTIV). It was mentioned that prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. On 19Dec2020 14:00, the patient experienced nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists. The patient did not receive any treatment for the events. Outcome of the events were not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/19/2020,1.0,PVT,ORILISSA; VIACTIV [CALCIUM CARBONATE;COLECALCIFEROL;PHYTOMENADIONE],,Medical History/Concurrent Conditions: Allergy; Headache; Latex allergy (but not anaphylactic); Migraine; Reproductive tract disorder NOS; Sulfonamide allergy,,,"['Arthralgia', 'Neuralgia']",UNK,PFIZER\BIONTECH, 921003,SC,,F,"she was administered the first dose of Pfizer COVID-19 Vaccine and later got COVID-19; she was administered the first dose of Pfizer COVID-19 Vaccine and later got COVID-19; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable female physician (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date in 2020 at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2020, the patient got the first shot of COVID vaccine and got COVID, she was wondering if she should still get the dose scheduled for 04Jan2021. The patient clarified that she is both a medical doctor/physician as well as the patient. She clarified that she was administered the first dose of Pfizer COVID-19 Vaccine and later got COVID-19. She called to ask if she should still get the second dose of COVID-19 Vaccine which is scheduled for 04Jan2021. She clarified that she does not think anything went wrong with the COVID-19 Vaccine. She does not think her receiving the COVID-19 Vaccine and developing COVID-19 are related; there was no way she would have had time to develop any protection from the COVID-19 Vaccine at the time she was exposed to COVID-19 2 days later. She does not think she can provide any relevant medical information that would be helpful for this report and declined to continue report. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported ""developing COVID-19"" after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 921004,TN,69.0,F,Mild itching - no signs of distress at discontinuation of monitoring - asked to f/u w/ PCP,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,,['Pruritus'],1,PFIZER\BIONTECH,IM 921005,NY,,F,"She tested positive for COVID-19; She tested positive for COVID-19; This is a spontaneous report from a contactable healthcare professional (patient) via Pfizer sales representative. A 55-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 22Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient, who is a frontline medical worker, informed that she tested positive for COVID-19 today (28Dec2020). The patient stated that she was informed by her employee health division at (place) that she was exposed to a patient with COVID-19 prior to her vaccination. She asked to be contacted regarding the timing of her second dose in light of her current status. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: There is not a reasonable possibility that reported ""tested positive for COVID-19"" is related to BNT162B2 vaccine. The patient exposed to a patient with COVID-19 before vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/28/2020,6.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 921006,,43.0,F,"Not feeling well; chills; muscle aches; headache; ears bothering; stuffy/runny nose; stuffy/runny nose; This is a spontaneous report from a non-contactable nurse (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0140), intramuscularly in the right arm, on 18Dec2020 at 06:00 (at the age of 43-years-old) at a single dose for COVID-19 immunization. Medical history included hypothyroid, breast cancer, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included levothyroxine (MANUFACTURER UNKNOWN) and tamoxifen (MANUFACTURER UNKNOWN). Other concomitant medications included unspecified multivitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced not feeling well, chills, muscle aches, headache, ears bothering, and stuffy/runny nose on 25Dec2020 at 20:00. The events were reported as non-serious. No therapeutic measures were taken as a result of the events. The clinical outcome of not feeling well, chills, muscle aches, headache, ears bothering, and stuffy/runny nose was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/25/2020,7.0,PVT,;,,Medical History/Concurrent Conditions: Breast cancer; Hypothyroidism; Penicillin allergy,,,"['Chills', 'Ear discomfort', 'Headache', 'Malaise', 'Myalgia', 'Nasal congestion', 'Rhinorrhoea']",1,PFIZER\BIONTECH,OT 921007,NJ,42.0,F,"About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 28Dec2020 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included the patient had allergies to medications, food, or other products, Bactrim and Sulfa based medications, & food sensitivities. Concomitant medication included birth control. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergies to medications: BACTRIM. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28Dec2020 About 45 minutes after injection, patient got a bloody nose out of nowhere (14:00), then at night at 22:00 (10:00PM) started having gastrointestinal (GI) symptoms & low grade fever. The events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever. Outcome of the events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever were recovering. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,,"Medical History/Concurrent Conditions: Food allergy (Allergies to meds, food, or other products: yes Bactrim and Sulfa based meds, & food sensitivities); Sulfonamide allergy (Allergies to meds, food, or other products: yes Bactrim and Sulfa based meds, & food sensitivities)",,,"['Abdominal discomfort', 'Epistaxis', 'Pyrexia']",1,PFIZER\BIONTECH,OT 921008,,34.0,F,"itchy rash on arms; This is a spontaneous report from a non-contactable other-HCP (patient). A 34-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration in the left arm on 22Dec2020 10:30 at a single dose for COVID-19 immunization at the hospital. The patient has no medical history. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced itchy rash on arms on 25Dec2020 12:00. Outcome of the event was recovering. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received antihistamine for the event. The event was assessed as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/25/2020,3.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['Rash pruritic'],1,PFIZER\BIONTECH, 921009,MA,65.0,F,"Recipient reported pulsating around the injection site during the 15 minute observation period. HR- 77-82, O2- 100%",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,WRK,,,,,,['Injection site discomfort'],1,MODERNA, 921010,GA,53.0,F,"Very sore arm; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in the right arm on 28Dec2020 08:30 at a single dose for COVID-19 immunization at the hospital. Medical history included hypertension (HTN) and diabetes mellitus (DM). The patient has no known allergies. The patient had received unspecified other medications the patient received within 2 weeks of vaccination. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced very sore arm on 28Dec2020 12:00. Outcome of the event was not recovered. No treatment was given for the event. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The event was assessed as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension,,,['Pain in extremity'],1,PFIZER\BIONTECH,OT 921011,NJ,31.0,F,"fever. Highest temperature was 101.1 F. I took tylenol which only brought it down to 100.6 F an hour later. Fever lasted for 5 hours total; back aches/achiness were better after sleeping for the night; headache; Fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at left arm on 24Dec2020 08:30 at single dose for covid-19 immunization. It was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included Baseline leukopenia. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 12 hours after the vaccine the patient developed back aches, headache, and a fever. Highest temperature was 101.1 F. The patient took Tylenol which only brought it down to 100.6 F an hour later. Fever lasted for 5 hours total. Fatigue and achiness were better after sleeping for the night. Events onset date was provided as 24Dec2020 11:30 PM. No treatment was received for the events of back aches, headache and fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the event fever was recovered on 25Dec2020 04:30, the outcome of the other events back aches, headache and fatigue was recovered on an unknown date in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Leukopenia,,,"['Back pain', 'Fatigue', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH, 921012,CA,41.0,F,"4 days the vaccine I got a high fever, body aches and tonsils were severly swollen and couldnt work",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/20/2020,3.0,PVT,no,no,no,,no,"['Impaired work ability', 'Pain', 'Pyrexia', 'Tonsillar hypertrophy']",1,PFIZER\BIONTECH,IM 921013,PA,41.0,F,"episode of vertigo; vomiting; nausea; This is a spontaneous report from contactable physicians (one is the patient). A 41-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EJ1685), via an unspecified route of administration on the left arm on 22Dec2020 at 12:45 at a single dose for immunization. Medical history included benign paroxysmal positional vertigo, but the patient has not had a flare of this condition in 3.5 years. The patient has no allergies to medications, food, or other products. Concomitant medications were not reported. The patient who has a history of Benign Paroxysmal Positional Vertigo (BPPV) had not had a flare of this condition in 3.5 years. Previously, it has only been brought on by scuba diving, then she woke up the day after receiving the Pfizer COVID 19 vaccine, on 23Dec2020 at 06:30 with an episode of vertigo consistent with prior episodes of BPPV. She has associated nausea and vomiting, and her symptoms mostly resolve with doing home exercises, rest and time. On 29Dec2020, that is day 7 after the vaccine and she still have mild vertigo. She has no fevers, chills, or myalgias. She stated that perhaps it was a coincidence but thought it might be worth reporting, and she fully intend to get the second Pfizer vaccine when available. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and no other medications were received by the patient within 2 weeks of vaccination. The events nausea and vomiting resolved in 2020 while the rest of the events was resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,WRK,,,Medical History/Concurrent Conditions: Benign paroxysmal positional vertigo,,,"['Nausea', 'Vertigo', 'Vomiting']",1,PFIZER\BIONTECH, 921014,IN,38.0,F,"itchy rash; This is a spontaneous report from a contactable nurse (patient). A 38-years-old female patient received the first dose of bnt162b2 (Pfizer BioNTech, Solution for injection, lot number: EK5730), via an unspecified route of administration on the left arm on 22Dec2020 17:45 at a single dose for immunization. Medical history was reported as none. The patient has no known allergies. The patient's concomitant medications were not reported. On 28Dec2020 at 06:00, 6 days after the initial Covid vaccine dose, the patient developed an itchy rash all over her body. Started first thing in the morning with itchy ankles, and by the afternoon, it was covering her whole body in patches and was intensely itchy. No other associated symptoms. No new detergent, clothing, foods, meds to explain. The patient left for work, showered, and took Benadryl. The rash went away and at the time of the report, feels fine. The patient was not diagnosed with COVID prior vaccination and was not tested post vaccination. The patient has no other vaccine in four weeks. The events resolved on an unspecified date in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/28/2020,6.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Rash pruritic'],1,PFIZER\BIONTECH, 921016,MI,48.0,F,"had a little side step/unbalance moment; left hand started tingling/tingling in left foot and left side of face; neck on left side felt like someone had hit it; injection site and whole deltoid was numb.; Left side of face, left foot and left ear all felt numb but with tingles; This is a spontaneous report from a contactable other HCP (patient). A 48-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0140), via an unspecified route of administration in Left arm on 28Dec2020 16:30 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at workplace clinic. Medical history included known allergies to food - vegetables, berries, shellfish, environmental. Concomitant medication in two weeks included desogestrel, ethinylestradiol (MIRCETTE), fluticasone propionate (FLONASE), iron, multi vitamin, elderberry w/z. The patient previously took benzoyl peroxide and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient waited 20min, went up to leave and while walking out had a little side step/unbalance moment. The patient thought nothing of it and went to car and was waiting in car for an extra 10 min. Her left hand started tingling, same tingling like if it was asleep and was waking up. Then she started to drive home, on the way home, noticed tingling in left foot and left side of face, neck on left side felt like someone had hit it. About 50 min after receiving injection, was at home, injection site and whole deltoid was numb. Left side of face, left foot and left ear all felt numb but with tingles. She had stopped timer after 2 hours. Tingling and numbness subsided sometime after 2 hours of receiving vaccine. Today (29Dec2020), everything felt fine. Injection site just felt like I got a shot, can barely notice it. Adverse event start date provided as 28Dec2020 05:15 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 29Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,MIRCETTE; FLONASE [FLUTICASONE PROPIONATE];,,Medical History/Concurrent Conditions: Environmental allergy; Food allergy; Shellfish allergy,,,"['Balance disorder', 'Hypoaesthesia', 'Injection site hypoaesthesia', 'Musculoskeletal discomfort', 'Paraesthesia']",1,PFIZER\BIONTECH, 921017,FL,44.0,F,"fatigue; Swollen left elbow (tender to touch); dizziness; headaches; high temperature; Swollen left elbow (tender to touch); This is a spontaneous report from a contactable other health professional (HCP, reported for herself). A 44-year-old female patient (not pregnant at the time of vaccination) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 1830), intramuscular on 22Dec2020 12:45 at single dose at left arm for COVID-19 immunization. Medical history and concomitant medications were none. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 22Dec2020 16:45 (04:45 PM), the patient experienced swollen left elbow (tender to touch), dizziness/headaches, high temperature, fatigue. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse events. The events were non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Body temperature', 'Dizziness', 'Fatigue', 'Headache', 'Joint swelling', 'Pyrexia']",1,PFIZER\BIONTECH,OT 921018,IL,50.0,M,"eye irritation; eyes turn red; blurry vision; difficulty keeping eyes open; BP 160/85; This is a spontaneous report from a contactable other hcp (patient). A 50-year-old male patient received bnt162b2 (lot number: EL0140), intramuscularly at arm left, first dose on 28Dec2020, at single dose, for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the within 2 weeks of vaccination. The patient experienced eye irritation, eyes turn red, blurry vision, difficulty keeping eyes open, BP 160/85 on 28Dec2020. No treatment received for the adverse event. The event was reported as non-serious. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PUB,,,,,,"['Blood pressure measurement', 'Eye disorder', 'Eye irritation', 'Hypertension', 'Ocular hyperaemia', 'Vision blurred']",1,PFIZER\BIONTECH,OT 921019,DE,38.0,F,"Urticaria, diffuse flushing head to toe, significant pruritus, tachycardia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,"Venlafaxine, emgality, ibuprofen, d3, b12, folic acid",None,Migraine Endometriosis,,"Iodine contrast (anaphylaxis) Latex (rash) Steri-strips (rash, hives)","['Flushing', 'Pruritus', 'Tachycardia', 'Urticaria']",1,MODERNA, 921020,KS,55.0,F,"Vertigo/it is now full blown vertigo; Stuffy head; She does not feel safe walking in her home; Nausea/ Acute nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK3730, expiration date: 20Mar2021), via an unspecified route of administration on 17Dec2020 at left deltoid, at single dose for covid-19 immunization. Medical history included patent foramen ovale in patient's heart from 2013 and ongoing, and the patient used to be 5'4"" and noticed the shrinkage before the Covid 19 vaccine and baby aspirin. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) from 2013 and ongoing for patent foramen ovale. The patient got the Pfizer vaccine on 17Dec2020 and on 25Dec2020 had experienced acute nausea and dizziness that persisted during weekend. Stated that it is now full blown vertigo. Stated that her doctor and pharmacist stated that people reported symptoms but did not know if these were symptoms of the vaccine because it is not listed. The patient experienced stuff head on 28Dec2020. Stated that the nausea comes and goes. Stated that she got physical therapy treatment Epley for vertigo on 28Dec2020 and it did some good but she woke it with it again this morning on 29Dec2020. Stated that the therapy lessened her nausea as well. Stated vertigo was manageable 25-26 and then did not feel safe walking in her home on 26Dec2020. Stated that she had no symptoms after she received it up until 25Dec2020. Stated that she will get the second dose 07Jan2021. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/25/2020,8.0,UNK,BABY ASPIRIN,Foramen ovale patent,"Medical History/Concurrent Conditions: Body height decreased (she used to be 5'4"" and noticed the shrinkage before the Covid 19 vaccine and baby aspirin)",,,"['Dizziness', 'Gait disturbance', 'Nausea', 'Upper respiratory tract congestion', 'Vertigo']",1,PFIZER\BIONTECH, 921021,CA,44.0,F,"FEVER, CHILLS, BODY ACHES, MALAISE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,SEN,,,,,,"['Chills', 'Malaise', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 921022,WI,51.0,M,"headache; arm soreness under injection; This is a spontaneous report from a contactable nurse (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685), intramuscular on 28Dec2020 12:00 in left arm at single dose for COVID-19 immunization. Medical history included depression, osa (obstructive sleep apnea syndrome) and obesity from an unknown date and unknown if ongoing. Concomitant medication included escitalopram oxalate (LEXAPRO), lansoprazole (PREVACID), clarithromycin (CLARITIN [CLARITHROMYCIN]) and losartan potassium (COZAAR). The patient had arm soreness under injection and slight headache on 28Dec2020 21:00 and took Tylenol and aleave as treatment. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,LEXAPRO; PREVACID; CLARITIN [CLARITHROMYCIN]; COZAAR,,Medical History/Concurrent Conditions: Depression; Obesity; Obstructive sleep apnea syndrome,,,"['Headache', 'Vaccination site pain']",UNK,PFIZER\BIONTECH,OT 921023,IN,39.0,F,"tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is a nurse anesthetist that got Covid vaccine on 17Dec2020 and tested positive for COVID-19 after the vaccine on 26Dec2020. The patient was wondering if have seen this. Stated that she was signed up for the booster scheduled for 05Jan2021 and wanted to know if they had any information about taking this. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug bnt162b2 to the reported events drug ineffective and COVID-19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/01/2020,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 921024,WA,61.0,F,"NOT SURE THIS IS EVEN AN OUTCOME OF THE VACCINE, BECAUSE I HAVE HAD THE HEAD COLD AT THE EXACT SAME TIME AS GETTING THE VACCINE ON JAN 31, 2020, BUT THOUGHT I SHOULD REPORT. 1. HAD A VERY MINOR HEADACHE THE TWO DAYS FOLLOWING THE VACCINE, JUST MILD DISCOMFORT. FULLY RESOLVED ON ITS OWN AFTER TWO DAYS. 2. MONDAY, JANUARY 4 WHEN I WOKE UP I FELT ""PUFFY"" - FEET AND HANDS WERE MILDLY SWOLLEN. NOTICED MY SHOES FELT TIGHTER THAN USUAL AND HANDS FELT A BIT DIFFICULT TO FULLY CLOSE. THIS IS FLUID RETENTION, AS IF YOU HAD TOO MUCH SALTY FOOD THE DAY BEFORE, AND I THOUGHT PERHAPS I HAD INGESTED MORE SALT THAN I REALIZED ON SUNDAY. BUT IT HAS BEEN YEARS SINCE THAT OCCURRED FOR ME AND MY DIET DOES NOT INCLUDE MUCH SALT OR PROCESSED FOODS. THEN TODAY MY FEET AND HANDS STILL FEEL PUFFY, SHOES STILL A BIT TIGHT AND HANDS A BIT HARD TO CLOSE SO THERE IS STILL SOME FLUID RETENTION GOING ON. THIS IS QUITE UNUSUAL FOR ME, I AM QUITE HEALTHY AND HAVE A GOOD DIET AND DON'T RECALL THIS HAPPENING BEFORE. AGAIN, NOT AT ALL SURE THIS IS RELATED TO THE VACCINE, IT MAY HAVE SOMETHING TO DO WITH THE HEAD COLD, BUT AS I AM NOT SURE AND THIS IS UNUSUAL AND HAS OCCURRED AFTER RECEIVING THE VACCINE, I FELT I SHOULD REPORT IT. THIS EFFECT IS VERY MILD AND I AM NOT CONCERNED ABOUT IT AND IT.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,PVT,NONE,"MILD COLD SYMPTOMS. HUSBAND HAD A COLD (CONGESTION, RUNNY NOSE, FATIGUE) THAT STARTED ON MONDAY, JANUARY 28TH. I STARTED PICKING UP SIMILAR SYMPTOMS TWO DAYS LATER ON WEDNESDAY, JANUARY 30TH. WE ARE BOTH STILL RECOVERING. HUSBAND HAD COVID-19 SWAB TEST ON MONDAY, JAN 28TH, IT WAS NEGATIVE. NEITHER OF US HAVE HAD SYMPTOMS SUGGESTIVE OF COVID 19. I AM A PROVIDER (NURSE PRACTITIONER) SO FEEL CONFIDENT ABOUT ASSESSING OUR SYMPTOMS AND DETERMINING WE SIMPLY HAD A STANDARD VIRAL COLD, PLUS HUSBAND TESTED NEGATIVE.",NONE,,NONE,"['Discomfort', 'Feeling abnormal', 'Fluid retention', 'Headache', 'Peripheral swelling']",UNK,MODERNA,IM 921025,VA,62.0,F,"fast heart beat; it was like she didn't feel good; low grade fever; nausea; headaches; chills; sore arm /arm soreness; tired; felt like she had a flu; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history included Diabetes, allergies, heart (Heart disorder). Concomitant medications included irbesartan (AVAPRO) for heart, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for allergies, metoprolol for heart, metformin for Diabetes, all were ongoing. The patient (Hospital scheduler/employee) had been experiencing side effects of the vaccine. She took the vaccine on 18Dec2020 and still experiencing nausea, headaches, and chills. She asked how long she would experience these side effects and if she needed to take anything. Patient reported she was exposed to someone who had COVID, her son's girlfriend had direct exposure to COVID and wanted to know how it would affect her. The patient further stated she was a hospital scheduler, she had the Pfizer Covid vaccine on 18Dec2020. She had a sore arm/arm soreness and was tired immediately after (18Dec2020), stated by Saturday 19Dec2020, she started having a low-grade fever, chills, headache, nausea, and still had the soreness in the arm. This went on for 2-3 days. Patient stated that up until now, she still had nauseous feeling that happened intermittently around early morning or mid-day, the chills were midday to early evening, it was like she didn't feel good, had to leave early from work. The fever only lasted a couple of days. She also had one isolated episode of fast heart rate that woke her up in the early hours of Sunday 20Dec2020. Caller stated she expected some of these effects to only last a couple of days but wanted to know if this was normal. She tried working 2 days last week and by mid-day she was just really tired, like she was about to get the flu, she felt like she had a flu just with no respiratory symptoms (De2020). She knew of one other coworker who was experiencing similar symptoms. No patient identifiers were provided, no further information provided. Patient did have history of allergies from when she was a child and was on medication, she was on over the counter medication Zyrtec for years, she didn't know if there could be a conflict between them. She received her vaccine part of the hospital. She also called because her son and his girlfriend live in her house and his girlfriend was exposed to someone who tested positive for Covid, she wanted to know how this may affect her since she had the vaccine. Investigation assessment was no. The outcome of the event ""sore arm /arm soreness"" was recovered in Dec2020, of ""low grade fever"" was recovered on 21Dec2020, of the events ""tired"", ""nausea"", ""headache"" and ""chills"" was not recovered, of the other events was unknown. Information about Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/01/2020,,PVT,AVAPRO; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ;,,Medical History/Concurrent Conditions: Allergy; Diabetes; Heart disorder,,,"['Body temperature', 'Chills', 'Fatigue', 'Headache', 'Heart rate increased', 'Influenza', 'Malaise', 'Nausea', 'Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH, 921026,CA,41.0,F,"after the vaccination i had a high fever, body aches and and my tonsils were swollen causing me to miss work",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/20/2020,3.0,PVT,no,no,no,,no,"['Lymphadenopathy', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 921027,TX,51.0,F,"tired and laid down; soreness to the injection site; paresthesia - tingling in hands and feet; hands and feet are cold/She felt cold; This is a spontaneous report from a contactable nurse (patient). A 51 years old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 28Dec2020 10:00 at single dose in the arm left for covid-19 immunisation. Medical history included change in taste, altered taste. Concomitant medications were none. Caller reported she was having side effects with the COVID vaccine she received yesterday (28Dec2020) morning at 10am. The patient experienced paresthesia, tingling in hands and feet and they are cold, said she ""felt cold"" and has soreness in the injection site on 28Dec2020 17:00. Caller confirmed the above details. Her hands got really cold and tingling to them and she was wondering what this is and went to her other half and asked him to take a look. It passed and lasted about 10-15 minutes and just thought it was unusual. Did a 5:00pm check-in and she was doing okay and everything was fine so she didn't mention it. At 7:00pm she got tired and laid down and started feeling the tingling in the fingers and her hands. Upon waking this morning when her feet met the ground it was intensified, the tingling, and she went to walk it out it got better, but she is still having the tingling in both fingers/hands and feet. Stated unsure of seriousness criteria for the tingling in hands and feet and coldness. Wondered if it is something she needs to worry about that is why she called. Is it something that could go away or worse like with Guillain-barre syndrome. It's not disabling, but it is concerning. Unable to provide the NDC or expiry for COVID vaccine given. Stated she can't understand the writing on the card provided for her with product details. Does see on card Pfizer, X40113 and stated the lot number looks to be either ""ES1685 or EJ1685 or E51685"". Unable to provide the dose/strength. Received this vaccine at her workplace. Mentioned in past she had flu vaccine with the additive of mercury and experienced changes in taste, altered taste. It was reported to her primary care provider. This was between 6-8 years ago, unable to provide name of vaccine, NDC, Lot, or expiry. Since then she only receives single dose vials instead of multidose vials. They were looking for a list of side effects and wanted to know if she should seek care for her symptoms, it's unusual. Wanted to know if the side effects she is having is something Pfizer has been seeing and will it go away and when. Previous transfer agent sent her to safety. It is difficult to navigate the website. Outcome of event fatigue was unknown, while outcome of other events was not recovered. Causal relationship between vaccine and events ""paresthesia, tingling in hands and feet"" ""hands and feet are cold"" ""soreness in injection site"" were related by agency and Primary Source Reporter. Information about Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Taste disorder (unspecified flu vaccine in past that had additive with mercury),,,"['Fatigue', 'Paraesthesia', 'Peripheral coldness', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 921028,TX,33.0,M,"Pruritos Hives on chest, back, stomach and upper arms; This is a spontaneous report from a contactable physician reporting for himself. This 33-year-old male patient received on 18Dec2020 11:00 first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot FJ1685) at single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies. Prior to vaccination, the patient was not diagnosed with COVID 19. Post vaccination, the patient had not been tested for Covid-19. Concomitant medications were not reported. On 24Dec2020, the patient had pruritus hives on chest, back, stomach and upper arms. No fevers/chills, difficulty breathing, throat swelling or other symptoms. Outcome was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/24/2020,6.0,PVT,,,Medical History/Concurrent Conditions: Seasonal allergy,,,['Urticaria'],1,PFIZER\BIONTECH, 921029,LA,31.0,M,"After receiving the vaccine, I was instructed to wait i for 15 minutes to ensure there were no reactions. I sat down in the provided chair, put my headphones in my ears, and started my timer on my watch for 15 minutes. after about 5 minutes I began to feel like my injection arm was a little weak, as if perhaps my arm was stiffening from the injection sore. I remember feeling slightly warm and started to read over the COVID-19 Vaccine symptoms sheet and then I blacked out (Fainted). The nurse in the hallway woke me up and was asking me if i was alright and then rushed me in the back room where they tested me and ensured I was ok. I had not eaten anything the morning of the vaccination shot and barely anything the night before. I have been experiencing higher levels of anxiety recently due to pressures of day to day life; school, work, etc. The nurses are thinking it is likely I had more of a reaction to the anxiety and low food or blood sugar (I am not diabetic), than a reaction to the vaccine itself. They did refer to my experience as sounding like Vasovagal syncope. I have never had this experience with any flu vaccine or shots before; I do not have a fear of needles or shots.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,,,,"['Blood glucose normal', 'Feeling hot', 'Loss of consciousness', 'Muscular weakness']",1,PFIZER\BIONTECH,SYR 921030,FL,56.0,F,"Nausea; Dizziness; vomited once; Chills/her left hand, where she got the shot, it does not feel right. It feels chilled.; soreness and pain at the vaccine site; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via intramuscular on left top upper arm where the muscles are below shoulder on 24Dec2020 at single dose for prevention because she works in hospital (COVID-19 immunisation). The patient medical history included high blood pressure. Concomitant medication included Hydrochlorothiazide started a year ago in 2019 at 12.5mg, once daily for High blood pressure. A later response of symptoms including nausea, dizziness, and vomited once. The patient got the COVID vaccine last Thursday, 24Dec2020. That day she had chills on 25Dec2020 06:00. (PENDING CLARIFICATION) She did not have any more problems with that. The second day, 25Dec2020 00:00 she had soreness and pain at the vaccine site. Then, it was ok but sore that day and then this morning. She is having dizziness, nausea and vomited one time at 07:30 on 29Dec2020. Started on 10:00 25Dec2020, her left hand, where she got the shot, it does not feel right. It feels chilled. On Monday, she was completely fine. She did not leave. At work on Sunday. No discomfort. Today morning, she has chills and started getting all the symptoms. Her left hand is not normal. She cannot say it is weak though. The left hand is chilled. She would like to know if Pfizer has reports of others with similar issues. She also would like to know if she should get the second dose and if she should see a physician about any of these. She works at the hospital and they were giving out to employees. There was no prescriber. It was not mandatory. Her daughter got it on 20Dec2020. She is a doctor and did not have any issues. Lots of people in her family got the vaccine. No further details provided. Regarding the first day she got chills, it was like an all over body chill. The chill described on her left hand went away on 25Dec2020, and today is feeling it again. Left hand is not bad cold, just chilly. She was still tired. She is not dizzy but didn't feel all that good. Outcome was provided as persisting but improved. She was tired the day she got the vaccine at night time on 24Dec2020, she went to bed early, slept all night and Friday morning she was also tired. By Friday afternoon, she felt better and was doing better until this morning and it started again. She did not feel this bad when she got the vaccine. Today, it is worse. She is nauseated, dizzy and tired. She never had a flu vaccine. This is the first time in her life getting a vaccine. The outcome of the events chills and left arm sore and painful was recovering and the outcome of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Blood pressure measurement', 'Chills', 'Dizziness', 'Fatigue', 'Nausea', 'Vaccination site pain', 'Vomiting']",1,PFIZER\BIONTECH,OT 921031,TX,32.0,M,"He got a little bit of tingling in his left arm; headache; Muscle soreness in the arm the vaccine was administered; His thumb looks swollen and inflamed; Muscle weakness; Experiencing swelling in left arm/thumb and numbness from tip of thumb to joint on opposite limb of administration.; Experiencing swelling in left arm/thumb and numbness from tip of thumb to joint on opposite limb of administration.; This is a spontaneous report from a contactable consumer (patient) reported that a 32-year-old male patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685 and Expiration Date 31Mar2021) intramuscularly on 22Dec2020 15:00 at single dose for Vaccination (covid-19 immunization). The patient's medical history and concomitant medications was reported as none. The patient experienced swelling in left arm/thumb and numbness from tip of thumb to joint on opposite limb of administration. Since Wednesday, 23Dec2020, he has been experiencing some numbness in the arm opposite of where the vaccine was administered. He clarifies the vaccine was administered in the deltoid of his right arm, and the numbness he is experiencing is in his left hand. His thumb has been partially numb since last Wednesday. He got a little bit of tingling in his left arm since last Wednesday (23Dec2020).The patient explains on Tuesday, 22Dec2020, when he was administered the vaccine he only had typical side effects that went away within 24 hours. He experienced headache and muscle soreness in the arm the vaccine was administered. Both of these symptoms went away and he has recovered completely. After 24-36 hours, he noticed numbness on hand opposite of the arm where the vaccine was administered. His thumb has been partially numb which has lasted about 6 days. He clarifies the numbness is on the palm side- which he was told was not related to the nerve. His thumb looks swollen and inflamed compared to the other. He also has noticed muscle weakness in the opposite arm. The patient states he can't recall if the numbness occurred within 24 hours but he knows by 24 hours, he did have the numbness. His thumb is partially numb on the side of the palm and up to the middle of his thumb where the joint is.Patient states yesterday the numbness was noticeably worse when he was sleeping. However, today the numbness seems to be back where it was before. He forgets about the numbness since he is not actively doing anything with that particular hand, but he doesn't forget about it completely. The numbness hasn't improved any, it's been consistently there and never went away. While reading off of his card, the patient cannot determine if the Lot number is an F or an E because the number is underlined. He thinks it might be an E. Patient was able to confirm the Lot number begins with an E after looking at the information sheet he was provided. He also sees the product number, CVX 208. Patient states he has no allergic reactions and nothing that he knows of that is an underlying condition. Patient states he hasn't had any testing done in regards to these events. He wanted to talk to the manufacturer and report it to the (Contact center name) first before he schedules something at Urgent Care. He wanted to check and see if what he is experiencing is a lesser known symptom. He couldn't find this information anywhere. The outcome of events, headache and muscle soreness was recovered on 23Dec2020. The outcome of Numbness in hand was not recovered. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/01/2020,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Headache', 'Hypoaesthesia', 'Inflammation', 'Muscular weakness', 'Myalgia', 'Paraesthesia', 'Peripheral swelling']",UNK,PFIZER\BIONTECH,OT 921032,IL,57.0,F,"I had most of side effects described. My ears hurt, like inside, but the most that bothers me today is that my heart feels like its beating and racing fast, sometimes feels like its pounding. Very uncomfortable, my chest feels.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,"Allegra 180mg po, women's vitamins, nasonex nasal spray, symbicort inhaler, ventolin inhaler as needed, use netipot as needed, but I did not take these on day of vaccination, was at work.",none,allergies and developed asthma because of allergies,,"Lots of allergies: Latex, all sea food, dogs, cats, feathers, dust mite, seasonal, and others. Corn starch, Kathon CG-Methylchloroisothiazolinone, Methylisothiazolinone, Perservatives in skin care products, shampoos, fabric softeners, Beware of hand cleanser at hospital, Formaldehyde, avoid any morgue exposure, and biopsy specimen bottles.","['Chest discomfort', 'Ear pain', 'Palpitations']",1,PFIZER\BIONTECH,IM 921033,Ca,56.0,F,"Loss of taste and smell; loss of taste and smell; This is a spontaneous report from a contactable healthcare professional, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration in the right arm on 23Dec2020 at 11:00 (at the age of 56-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020, the patient experienced loss of taste and smell, reported as non-serious. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the loss of taste and smell were not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,,,,,,"['Ageusia', 'Anosmia']",1,PFIZER\BIONTECH, 921034,TX,,F,"patches appearing all over my body, these patches are red; patches are red like hive patches; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age (Age: 38; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 22Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got vaccinated with the Pfizer-BioNtech covid-19 vaccine on 22Dec2020. And since that day she started experiencing a side effect described as ""patches appearing all over my body, these patches are red like hive patches. These patches pop up and stay for a couple of hours"". The patient wanted to know if the appearance of red patches described as ""hive patches"" all over the body has been reported by someone as a side effect due to the use of the vaccine or if this is independent from the vaccine. The patches are still appearing. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,UNK,,,,,,"['Erythema', 'Urticaria']",UNK,PFIZER\BIONTECH, 921035,PA,54.0,F,"Left arm pain - mild; Mild lightheadedness; This is a spontaneous report from a contactable nurse (patient herself). A 54-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EK9231, expiration date unknown), via an unspecified route of administration on the left arm on 28Dec2020 at 11:15 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included hypertension (HTN), obesity, hypothyroid, allergies to penicillin (PCN), and was diagnosed (Dx) with an unknown virus in Feb2020. Concomitant medications included chlorthalidone (CHLORTHALIDONE), levothyroxine sodium (SYNTHROID), olmesartan medoxomil (BENICAR), atenolol, and minoxidil (PANT). The patient previously took levofloxacin (LEVAQUIN), gatifloxacin (TEQUIN), and morphine and experienced allergies from all these medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, the patient experienced left arm pain - mild and mild lightheadedness. The reporter assessed the events as non-serious. The patient did not receive any treatment for the events. The outcome of both the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,PVT,CHLORTHALIDONE; SYNTHROID; BENICAR; ; PANT,,Medical History/Concurrent Conditions: Hypertension; Hypothyroidism; Obesity; Penicillin allergy; Viral infection (Dx),,,"['Dizziness', 'Vaccination site pain']",1,PFIZER\BIONTECH, 921036,MD,41.0,F,"Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Nausea; Vomiting; Worsening headache w/ photophobia; Subjective fever; This is a spontaneous report from a contactable physician (patient). A 41-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=59267-1000-1 /EH9899), via intramuscular on 28Dec2020 09:45 at single dose on her right arm for Covid-19 immunization. Medical history included psoriasis. The patient had no known allergies. Allergies to medications, food, or other products was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that 6h after administration on 28Dec2020 16:00, the patient experienced fatigue, myalgia, injection site pain; 10h after (in addition to above) on 28Dec2020, the patient experienced headache (frontal), joint pain, chills and 12-28h after (in addition to above) in Dec2020, the patient experienced nausea, vomiting, worsening headache w/ photophobia, subjective fever, joint pain. The patient was not received any treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/01/2020,,PVT,,,Medical History/Concurrent Conditions: Psoriasis,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Photophobia', 'Pyrexia', 'Vaccination site pain', 'Vomiting']",1,PFIZER\BIONTECH,OT 921037,AZ,21.0,F,"nauseous; weak; no appetite; numbness on the skin of my arms and legs; I was post Ictal for 2+ hours; seizures/having 2 non epileptic seizures; dizzy and lightheaded; This is a spontaneous report from a contactable nurse (patient). A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. Batch/lot number: EK5730), intramuscularly on 28Dec2020 07:45 AM at right arm, at single dose for covid-19 immunization. Medical history was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient received vaccine around 7:45 AM. Within 2 minutes she felt extremely dizzy and lightheaded on 28Dec2020. She sat down and drank some Gatorade and took deep breaths. The feelings persisted 5 minutes later. She then woke up after having 2 non epileptic seizures while still in 15m waiting period, (This included posturing and color change) a rapid response was called and she was taken to the ER. She was post Ictal for 2+ hours. Dizzy and nauseous, weak and no appetite for the rest of the day. She had no history of epilepsy. She also have numbness on the skin of my arms and legs within 24 hours of the vaccine. Onset date of all events (except dizzy and lightheaded) was reported as 28Dec2020 08:00AM. Treatment fluids, Zofran was received for all events. All event resulted in emergency room. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovered with sequel.; Sender's Comments: A possible contributory effect of suspect BNT162BW on reported seizures cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Decreased appetite', 'Dizziness', 'Hypoaesthesia', 'Nausea', 'Postictal state', 'Posturing', 'Seizure', 'Skin discolouration']",1,PFIZER\BIONTECH,OT 921038,PA,40.0,F,"numbness and tingling in all four extremities; numbness and tingling in all four extremities; intermittent weakness in my hands, arms and legs; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0140), via an unspecified route of administration on the left arm on 18Dec2020 12:30 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history reported as none and the patient had no known allergies. The patient's concomitant medications were not reported. It was mentioned that prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. On 19Dec2020 13:30, the patient was experiencing numbness and tingling in all four extremities after the first dose of the vaccine. The patient also experienced intermittent weakness in hands, arms and legs. It was also mentioned that the patient had numbness and tingling in all four extremities for the past 10 days. The patient did not receive any treatment for the events. Outcome of the events were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/19/2020,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Hypoaesthesia', 'Muscular weakness', 'Paraesthesia']",1,PFIZER\BIONTECH, 921039,OR,34.0,F,"Fever; chills; fatigue; body aches; sore arm; This is a spontaneous report from a contactable other health professional (patient). A 34-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 24Dec2020 09:15 at single dose on left arm for COVID-19 immunization in hospital. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, fatigue, body aches, sore arm from 24Dec2020 21:00. No treatment received for the adverse events. The outcome of the events was recovered on an unspecified date in Dec2020. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. No follow-up attempts are possible, information about batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,,,,,,"['Chills', 'Fatigue', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,OT 921040,TX,47.0,F,"Right facial numbness; This is a spontaneous report from a contactable other healthcare professional. A 48-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration on 16Dec2020, 18:00 at single dose (dose 1, reported as right arm, and also reported as left arm) for COVID-19 immunization. Medical history included DM, hypothyroid, and HTN from an unspecified date. The patient's concomitant medications were not reported. No other vaccines were given in four weeks. Patient has no COVID prior vaccination and did not undergo COVID testing post vaccination. The patient has no known allergies. The patient experienced right facial numbness on 16Dec2020 19:00, also reported as 50 minutes after receiving the vaccine. She was instructed to take one dose of BENADRYL as treatment. It was reported that numbness last for about 2.5 hours. Outcome of the event was recovered on 16Dec2020. The event was reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension; Hypothyroidism,,,['Hypoaesthesia'],1,PFIZER\BIONTECH, 921042,UT,37.0,F,"Received first COVID vaccine. A few minutes after vaccine, arm felt abnormal, tingly, then 5 minutes after that felt lightheaded and tachycardic. Rapid response called while patient laid flat, transported to the ED. In the ED, vital signs were stable and was able to ambulate without problems.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,,none,,,None,"['Dizziness', 'Feeling abnormal', 'Paraesthesia', 'Tachycardia']",1,PFIZER\BIONTECH,IM 921043,CA,44.0,F,"pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; teeth hurting; cheeks were flushed and the neck; chin being red/redness on the chin; itching on the face; This is a spontaneous report from a contactable Other HCP (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration in left arm on 18Dec2020 at single dose for covid-19 immunisation. Medical history included lymphoma, hodgkin's disease, inflammation. Concomitant medication included prednisone. She had to finished 2 weeks worth of prednisone, it was for inflammation in her abdomen, she had finished the prednisone either on the 18Dec2020 the following day. The patient got her first dose of the covid vaccine on 18Dec2020. She was schedule for her 2nd dose of the covid vaccine on 08Jan2021. On 18Dec2020 after receiving the vaccine her cheeks were flushed and the neck, it first started with the chin being red, an hour later her cheeks and neck were flushed, but she felt this symptom was normal. She also added that on the day of the vaccine she had itching on the face, and redness on the chin, this was on 18Dec2020 about an hour after receiving the vaccine. The enlarged lymph nodes on her neck were noticed on 23Dec2020, as well as the severe sore throat, earache, and teeth hurting. Her pain with the turning of the head was more so noticed on 24Dec2020. It's painful to turn her head back and forth but she thought this was because of lymph nodes. She stated that she had a history of lymphoma and so swollen lymph nodes did worry her. The doctor gave her an antibiotic for it, and she was actually on a second round because she was not any better. The antibiotic was prescribed on 24Dec2020, and the second round started today 29Dec2020. The first antibiotic she was prescribed was Azithromycin also known as a Z-pak. The second antibiotic she was prescribed was amoxicillin clavulanate (AUGMENTIN). Her lymph nodes were getting better starting today 29Dec2020, today was the first date that she was feeling better overall. The patient underwent lab tests and procedures which included rapid covid test negative on 24Dec2020, strep throat swab negative on 24Dec2020. She has had no positive test for Covid prior the vaccine. She had been tested like 5 times now, all negative. She had no Covid antibody test prior to vaccine. She had no issues with vaccines in the past. The outcome of event cheeks were flushed and the neck was unknown. The outcome of events enlarged lymph nodes on her neck, severe sore throat, earache, teeth hurting was recovering. The outcome of events chin being red/redness on the chin, itching on the face was recovered on 18Dec2020. The outcome of event pain with the turning of the head was recovered on 28Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Hodgkin's disease; Inflammation; Lymphoma,,,"['Ear pain', 'Erythema', 'Flushing', 'Headache', 'Lymphadenopathy', 'Oropharyngeal pain', 'Pruritus', 'SARS-CoV-2 test', 'Toothache']",1,PFIZER\BIONTECH, 921044,CT,33.0,F,"cheeks and tongue felt full-monitor- push fluids, v/s, sent to nearest ER for evaluation",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PUB,none,none,none,,"pcn, tobramycin, e-mycin","['Swelling face', 'Tongue disorder']",1,MODERNA,IM 921045,CA,35.0,F,"Feverish; Severe arm pain; Severe arm pain and decreased mobility; Headache; Fatigue; Sore throat; Body aches; This is a spontaneous report from a contactable Nurse(patient). A 35-year-old female patient received first dose (BNT162B2, Lot number Eh9899), via an unspecified route of administration on 28Dec2020 17:30 at 35 years old at Arm Left at single dose for COVID-19 immunization. The medical history included Allergies to Penicillin. The concomitant medications were none. On 28Dec2020 21:30 the patient experienced Severe arm pain, decreased mobility, Headache, Fatigue, Sore throat, Body aches, Feverish. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PUB,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Fatigue', 'Headache', 'Mobility decreased', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 921046,MT,26.0,F,"I had a very sore arm; lightheadedness/dizziness; back ached; felt like I had the flu - body aches; felt like I had the flu - body aches; shivering/chills; nausea; fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 26-year-old female patient received bnt162b2 (lot number: EH9899, brand=Pfizer-BioNTech), via an unspecified route of administration, at arm left, first dose on 16Dec2020 10:00, at single dose for COVID-19 immunization. No relevant medical history. No allergies to medications, food, or other products. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), spironolactone (SPIRONOLACTONE) both from an unspecified date for unspecified indication. The patient is not pregnant at the time of vaccination. Age at vaccination was 26. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. About 12 hours after the COVID vaccine (also reported as from 16Dec2020 21:00), the patient suddenly felt like had the flu-body aches, shivering, nausea, fatigue, chills, but no fever. She went to bed and woke up the next morning (17Dec2020) feeling fine, except she had a very sore arm and was fatigued. Also had some lightheadedness/dizziness that second day and her back ached. No treatment was received for the adverse event. The events were reported as non-serious. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,PVT,TRI-SPRINTEC;,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Back pain', 'Chills', 'Dizziness', 'Fatigue', 'Influenza', 'Nausea', 'Pain', 'Vaccination site pain']",1,PFIZER\BIONTECH, 921047,OH,32.0,F,"Became really nauseous, & almost threw up, but made it to work & took a disintegrating zofran, which helped relieve SE within about 5-10 minutes. Of course, arm is extremely sore too; can barely lift arm past rib cage.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Advil Migraine about 2 hours prior to vaccination. Taken Elderberry gummy vitamin in the AM of reaction (about 5 AM).,"none, other than frequent migraines.",,,"Food sensitivities: egg, gluten, dairy, blueberries, cranberries","['Mobility decreased', 'Nausea', 'Pain in extremity']",1,MODERNA,IM 921048,,32.0,M,"Myalgia; chills; low grade fever; headache; This is a spontaneous report from a non-contactable physician. A 32-year-old male patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown since unable to locate or read the details) via Intramuscular on 21Dec2020 at single dose in the arm right for covid-19 immunisation. Medical history and concomitant medications were not reported. On 21Dec2020, the patient experienced Myalgia, chills, low grade fever, headache. The patient did not receive any treatment. Outcome of events was recovered in Dec2020. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,WRK,,,,,,"['Body temperature', 'Chills', 'Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,OT 921049,ME,40.0,F,"bilateral tinnitus; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date were not reported, intramuscular in the arm left, first dose on 19Dec2020 09:30 at a single dose for Covid-19 immunization. Medical history included hypothyroidism. The patient previously took penicillin and had allergy with hives. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid 19 nor was she tested for Covid 19. Concomitant medication included levothyroxine. The patient noticed onset of bilateral tinnitus that was constant and new since the injection. She doesn't know that it was related but it was very new in onset about 24 hrs after the vaccine and quite an obvious change. She mentioned that she is only 40 and has no known hearing loss and an ENT physician so can pinpoint no other triggers. The event resulted to a doctor or other healthcare professional office/clinic visit. No treatment received for the event. The outcome of the event bilateral tinnitus was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/20/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Hypothyroidism,,,['Tinnitus'],1,PFIZER\BIONTECH,OT 921050,SC,30.0,F,"Initially soreness in injection area; body backs with back, hip, and knee pain limiting mobility; body backs with back, hip, and knee pain limiting mobility; limiting mobility; Fatigue; chills; This is a spontaneous report from a contactable Other HCP (patient). A 30-year-old female patient received the first dose of BNT162B2 (lot number: EJ1685), via an unspecified route of administration in right arm, on 28Dec2020 03:30 PM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Relevant medical history included COVID-19. No other vaccines were received within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. The patient experienced Initially soreness in injection area on 29Dec2020 10:30 AM. At 19 hours after vaccination started to experience body backs with back, hip, and knee pain limiting mobility on 29Dec2020 10:30 AM. Fatigue and chills fan at 24 hour mark and are continuing now at 28 hours on 29Dec2020 10:30 AM. No treatment was received for the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,,,Medical History/Concurrent Conditions: COVID-19,,,"['Arthralgia', 'Back pain', 'Chills', 'Fatigue', 'Mobility decreased', 'Vaccination site pain']",1,PFIZER\BIONTECH, 921051,TX,49.0,F,"welts around body, buttocks, arm, legs. vaccine site redness, puffiness, warm to touch",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,WRK,"multivitamin zinc, vitamin d, vitamin c, Immune booster hydrochlorothiazide/losartan",none,hypertension,,none,"['Injection site erythema', 'Urticaria', 'Vaccination site swelling', 'Vaccination site warmth']",1,PFIZER\BIONTECH,IM 921052,IL,1.17,F,"was nursed by mother who received Pfizer COVID vaccine; one twin who kind of gets allergic reactions to vaccines; body rash; Low grade fever; fussy/ fussiness; This is a spontaneous report from a contactable other health professional (HCP) (patient's mother). This other HCP reported information for both mother and babies (boy girl twins). This is a baby report (girl twin). A 14-month-old female patient received the first dose of BNT162B2 (Lot# EJ1685), via transmammary on 16Dec2020 at single dose for COVID-19 immunization. The patient medical history included like for the 12 month appointment, she got 4 to 5 shots, and got a full body rash and fever for a couple days, but it's hard to say, like she got a flu shots and whatever ones that go with it. There were no concomitant medications. The patient was nursed by mother who received Pfizer COVID vaccine. The patient's mother got her first dose of vaccine, later clarified as the Pfizer COVID vaccine, on 16Dec2020, and she was nursing twins, they are about 14 months now. She had boy girl twins and the patient was shorter than her brother, since she was a girl. She was normal height, in the 50th percentile for age. The patient's mother had no adverse effect, she had normal side effects, and one twin (the girl) who kind of gets allergic reactions to vaccines, like body rash and fever, nothing serious, the other one (the boy) has no issues. Afterwards the twin who gets side effects, was fussy and had a low grade fever, but nothing serious, and she was encouraged to report to Pfizer, she didn't know if this is significant, or anything to worry about with the second dose. The mother stated her daughter was fussy that afternoon, on 16Dec2020, the mother had nursed before she left, say around 10:30 AM, and probably nursed her around 3 PM, afterwards, and the next time she nursed, she was fussy, by early afternoon/evening a couple hours after nursing, The fussiness was just that day and evening, and her daughter has the low grade fever that evening was 16Dec2020. Caller gave her some infant tylenol and it went away, and comforted her, since she got fussy, and it went away that evening. Stated the next morning she gave her the tylenol as well and she was fine. Stated the pediatrician might have that if Pfizer wishes to contact, but she thought maybe after MMR, probably what she had gotten, the problem was she had so many at once, so it's hard to say which ones, like for the 12 month appointment, she got 4 to 5 shots, and got a full body rash and fever for a couple days, but it's hard to say, like she got a flu shots and whatever ones that go with it. Stated it's interesting, the two kids to compare, her son doesn't usually get vaccine reactions, her daughter does, and it's interesting he was completely fine and she was fussy. The outcome of the events low grade fever and fussy/ fussiness was recovered on 16Dec2020. The outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518603 baby case (boy twin);US-PFIZER INC-2020518990 maternal case",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,UNK,,,,,,"['Allergy to vaccine', 'Exposure via breast milk', 'Infant irritability', 'Pyrexia', 'Rash']",1,PFIZER\BIONTECH,OT 921053,IN,46.0,F,"Patient had SVT; flushing; hives; heart rate increased to 160's (had been 180's earlier in the day); This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the first dose of BNT162B2 (lot number: EK5730), via intramuscular, on 28Dec2020 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, it's unknown if the patient was tested for COVID-19. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient had SVT, flushing, hives 20 min after receiving vaccine on 28Dec2020. Patient was taken to ED and evaluated. SVT resolved. Patient sent home on heart monitor. Later that night while in bed, heart rate increased to 160's (had been 180's earlier in the day) and patient was admitted to hospital. Patient is a NP. Treatment received for the adverse event included cold water to face, vagal massage. The outcome of the event""Patient had SVT"" was recovered on 28Dec2020 and of other events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events supraventricular tachycardia, flushing, hives, heart rate increased cannot be excluded based on the compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Cardiac monitoring abnormal', 'Flushing', 'Heart rate increased', 'Supraventricular tachycardia', 'Urticaria']",1,PFIZER\BIONTECH,OT 921054,NC,53.0,M,"achy joints; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection, lot number: EK5730, intramuscular in the left shoulder on 23Dec2020 12:00 at a single dose for covid-19 prophylaxis. The patient's medical history was not reported. There were no concomitant medications. The patient's historical vaccine included Shingrix and experienced weak, tired and achy that lasted for 24 hours, he received this 6 months ago (2020). The patient experienced achy joints and fatigue, both on 24Dec2020 at 10:00 with outcome of recovering. The patient called about the Covid-19 vaccine and reported that he received it last Wednesday on 23Dec2020. He said that since then he has had achy joints and fatigue that started on Thursday 24Dec2020 that has been going on through today. He received the vaccine at the hospital where he works at. His symptoms are persisting, but stated that he does feel a little bit better today. He said that it does not seem to be getting worse. He read achy joints and tiredness were some of the reactions to be expected with the medication, and now he was thinking it was a little more long term than what it should be.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,,,,,,"['Arthralgia', 'Fatigue']",UNK,PFIZER\BIONTECH,OT 921056,NY,50.0,F,"fair amount of bleeding after the needle was removed; good size bruise; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient started to received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. Other products, patient history and investigation assessment was No. There were no concomitant medications.She provided her weight as 140, 142, or 143 lbs. After administration of the COVID 19 vaccine there was a fair amount of bleeding after the needle was removed. It could have been the administration process. Another resident here had the same experience, but she was unsure if the resident received the Pfizer of Moderna vaccine. This was day 5 and the caller still had a bruise. The current caller said she developed a good size bruise, and she didn't bruise easily. She didn't have a prescribing doctor. She got it at the city hospital, where she worked. She was not on anticoagulants. She had not taken aspirin or Motrin. The outcome of the event bruise was not recovered, of other event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Contusion', 'Vaccination site haemorrhage', 'Weight']",UNK,PFIZER\BIONTECH, 921057,AZ,48.0,M,"Hypertensive crisis; Numbness to my left ear; progressively it went down to my mandible, my face and my left shoulder numbness; Radial blood pressure cough; This is a spontaneous report from a contactable nurse reporting for himself. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. Medical history reported as none. There were no concomitant medications. During the administration the patient did experience some types of reaction where it wanted medical supervision. So, basically when he did got the injection he was waiting for his 15 minute prolapse. But within probably he would say 7 to 8 minutes he started to experiencing some numbness to his left ear and usually he thought it was secondary to the that he had (not clarified) but progressively it went down to his mandible, his face and his left shoulder numbness and he was experiencing some numbness that radiate towards his fingertips only to the left side. At that time he waived to the Nurse to supervise and at that time he wait again and a Physician came over. He checked his pulse and noted that he had normal rhythm during the pulse check and at that time and he had Emergency medical technician (EMT) come over. The EMT checked his blood pressure he thought multiple times through the left and to the right brachial. He was having what they would consider a hypertensive crisis where systolic were in 170's, 180's, diastolic numbers were between like 120's and 130's and his heart rate was in 70's. So, initially it was not anxiety induced. But he do not have no blood pressure. They wanted he to go to the hospital to treat the hypertensive crisis that was in. The patient opted not to. So he went home in a quieter environment he did have a radial blood pressure cough that he had been checking his blood pressure rigorously, tried different techniques and now he was back to normal state to 120-130 systolic and his diastolic was 70-80. This instance was weird that he did not see as a part of one of the side effects listed with Pfizer BioNTech Vaccine. No treatment received for the events, because he had no history of hypertension it was just more of decreasing the ambient around he. At that time he wanted to go to a quiet environment, took a shower and check his blood pressure. He did orthostatic while laying down sitting up, standing up and he was not hypertensive. For the causality, the nurse stated, ""I think it did. This is a fact I mean I was doing fine prior to administration and then this event is slowly subsiding."" The outcome of the events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported hypertensive crisis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Hypertensive crisis', 'Hypoaesthesia']",UNK,PFIZER\BIONTECH, 921058,MI,,F,"huge welt on her arm; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. Medical history included covid-19 from end of Oct2020 to an unknown date. The patient's concomitant medications were not reported. The patient reported that she is an nurse in the ICU. She had received the 1st dose of the vaccine after she had covid the end of Oct2020. Her reaction to the vaccine was, she felt exactly how she did when she had covid. It lasted 3 days. She had a huge welt on her arm. Her pulmonologist suggested that she contact Pfizer for advice on if or when she should receive the 2nd dose, which is currently due 08Jan2021. Outcome of the event huge welt was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of giant urticaria due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Illness', 'Urticaria']",1,PFIZER\BIONTECH, 921059,NH,34.0,F,"1310:Pt received vaccine. 1315: Pt's husband honked horn as patient reports feeling dizzy, lightheaded, and nauseous. Pt has history of neurocardiogenic syncope and states this often happens to her with vaccine administration. HR 130 BP 120/70. Pt with seat reclined. 1320: Pt extracted from car by RNx2, assisted to cot to lay flat. Pt states feeling much better laying on cot. Pt observed 1:1 by this RN. Pt reports feeling better. Offered to call ambulance for patient, pt declines. States this is very normal for her. 1330: Pt able to sit up. 1345: Pt stands and assisted back to car with slow transition. Pt observed for additional 10 minutes in parking lot. Pt states she feels comfortable going home and resting. educa educated regarding reasons to go to Emergency Department or call 911, pt verbalizes understanding. education provided to patient's husband regarding things to monitor for. Both are agreeable and feel safe with plan. Pt encouraged to speak to Agency regarding second dose plan. Recommend patient recieves dose #2 at a healthcare facility while being continuously monitored by healthcare personnel and with the ability to provide immediate intervention. Pt verbalizes understanding.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,OTH,"propanolo, incassia, desipramine, tizanidine",strep throat in september,neurocardiogenic syncope,,"Botox, Contast, Dye","['Dizziness', 'Nausea']",1,MODERNA,IM 921060,GA,,F,Appendicitis / colic pain to her right midsection; This is a spontaneous report from a contactable Other-HCP (Nurse Practitioner). A female patient of an unspecified age received bnt162b2 (BNT162B2) at single dose on 20Dec2020 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. In Dec2020 3 days after vaccination she experienced colic pain to her right midsection. She was diagnosed with appendicitis. The outcome of events was unknown. Information about lot/batch number has been requested.; Sender's Comments: The event appendicitis is most likely an intercurrent medical condition and is assessed as unrelated to BNT162B2.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/01/2020,,UNK,,,,,,"['Abdominal pain', 'Appendicitis']",UNK,PFIZER\BIONTECH, 921061,OH,47.0,F,"Fever; feels weak; tired; lightheaded; pain at the injection site; back and hip pain; back and hip pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included sick with coronavirus infection from 11Aug2020. There were no concomitant medications. The patient was experiencing the expected side effects fever, feels weak, tired, lightheaded, pain at the injection site in the right deltoid, hip and back joint pain on Dec2020. She does not know exactly when these events started but that she noticed them when she was trying to sleep last night. Outcome of the events was not recovered. The events were considered serious due to being medically significant.; Sender's Comments: Based on temporal association, the causal relationship between BNT162b2 and the events pyrexia, asthenia, fatigue, dizziness, vaccination site pain, back pain and arthralgia cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: Corona virus infection,,,"['Arthralgia', 'Asthenia', 'Back pain', 'Dizziness', 'Fatigue', 'Injection site pain', 'Pyrexia']",1,PFIZER\BIONTECH, 921062,,,U,"a high fever; extreme fatigue; have allergies; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the first of eight reports. Only this report is serious. A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer version of the vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 immunisaton. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine on Dec2020. The patient was admitted to the ICU. The patient had allergies, but it was unknown what the allergies are to. The outcome of events was unknown. No follow-up attempts are possible. Information on batch/Lot number can not be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520700 same reporter/drug/AE, different patients;US-PFIZER INC-2020520703 same reporter/drug/AE, different patients;US-PFIZER INC-2020520699 same reporter/drug/AE, different patients;US-PFIZER INC-2020520704 same reporter/drug/AE, different patients;US-PFIZER INC-2020520705 same reporter/drug/AE, different patients;US-PFIZER INC-2020520701 same reporter/drug/AE, different patients;US-PFIZER INC-2020520702 same reporter/drug/AE, different patients;US-PFIZER INC-2020520700 same reporter, drug, events, and different patients;US-PFIZER INC-2020520701 same reporter, drug, events, and different patients",Not Reported,,Not Reported,Yes,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Fatigue', 'Intensive care', 'Pyrexia']",UNK,PFIZER\BIONTECH, 921063,WY,32.0,F,Rash all over body-itchy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,PUB,Orthocyclen Effexor 150mg,None,Epstein Barr Virus,Erythromycin-age 3- anaphylaxis,Erythromycin Imitrex,"['Pruritus', 'Rash']",1,MODERNA,IM 921064,FL,74.0,F,"extremely lightheaded; This is a spontaneous report from a contactable physician (patient's husband). The physician reported same events for 2 patients. This is 2nd of 2 reports. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 30Dec2020 at a single dose in deltoid left for Vaccination/COVID-19 vaccine. Medical history included COVID-19 in Jul2020, ongoing overweight. There were no concomitant medications. The patient experienced extremely lightheaded on 30Dec2020. Reporter seriousness for extremely lightheaded is medically significant. The reporter stated his wife (patient) was feeling about the same thing and believed his wife was feeling better. She got up and was walking around and is no longer beside him. No Emergency Room or Physician Office visited. The outcome of event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event dizziness cannot be excluded. ,Linked Report(s) : US-PFIZER INC-2020520760 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,,Overweight,Medical History/Concurrent Conditions: COVID-19 (had COVID-19 in July),,,['Dizziness'],1,PFIZER\BIONTECH, 921066,WA,45.0,F,"About 4-5 minutes after receiving the shot, experienced heart racing (180 bpm), and feeling faint. Breathing was fine. Felt slightly tight in the throat. Also experienced diarrhea twice within the 40 minutes following the vaccine. The heart racing and faint feeling lasted about 5 minutes. The throat tightness lasted closer to 1.5 hours, but was never severe- just noticeable. Within 2 hours of the vaccine, was feeling much better. Never experienced actual difficulty breathing. I reported to employee health RN and personal physician.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Oral contraceptives.,None.,None.,Received varicella series in September/October 2020 and had a localized reaction at the site.,None.,"['Diarrhoea', 'Dizziness', 'Palpitations', 'Throat tightness']",UNK,MODERNA,IM 921069,PA,36.0,M,"dull injection site pain within 1 hour of injection. Moderate-severe injection site pain, minor chills, max temperature of 99.9F at 6 hours post injection. At 15 hours post injection, moderate injection site pain and lethargy/discomfort were the only symptoms that remained. No redness or swelling at any point.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"vitamin d, vitamin b12",,,"fever, chills, aches after flu vaccine at 29 years old, vaccinated 10/9/13. symptoms resolved in 24 hours.",,"['Body temperature increased', 'Chills', 'Discomfort', 'Injection site pain', 'Lethargy']",1,MODERNA,IM 921073,MA,26.0,F,"I woke up around 1:30 am on January 5th with a temperature of 99.9 degrees F. By 3:00 am, my temperature spiked to 100.5 degrees F. By 7 am, my temperature had returned to normal, around 98.6 degrees F and I have felt fine the rest of the day, besides some soreness at the injection site. I did not take any medications to help with the fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Alyacen 1/35 birth control tablets,None,Hypothyroidism,,NKDA,"['Injection site pain', 'Pyrexia']",1,MODERNA,IM 921078,CA,40.0,F,"pain, ache behind his right eye, that is still there fuzzy vision that lasted for 30 minutes warmth on top of head and around his ear",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Eye pain', 'Visual impairment']",1,MODERNA,SYR 921079,NY,40.0,F,"large 13-15 cm hive, itchy, tender, elevated and red",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/04/2021,11.0,PVT,Accutane 40mg,,,,,"['Erythema', 'Pruritus', 'Swelling', 'Tenderness', 'Urticaria']",UNK,MODERNA,IM 921080,NY,63.0,F,Post vaccination x 1 week. Sight is reddened/mod swelling/terrible intching,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PVT,Advil,Nothing,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 921083,MI,36.0,M,"Patient reported a ""migraine headache at the back of the head within 5 minutes of receiving the Pfizer COVID 19 vaccine at 9:45am on 01/04/2021. Symptoms were quickly followed by itching of the head and ears. Within twenty minutes his tongue, lips, and throat felt tingly and numb. He stated he was taken by EMS to hospital where he was given Benadryl and monitored for 2 hours. Today he reports a mild headache, chills, soreness at the site of the injection with slight burning, and fatigue. He stated, ""I'm fine."" Infection Prevention specialist for hospital reports that patient chart indicated he had no evidence of tongue or lip swelling. His vitals at the ER were stable and he was observed for over an hour. He was given oral zofran, acetaminophen, and benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,"Multi-vitamin - Animal pac gabapentin - 300 mg 2x daily tylenol 4 - 300 mg every 6 hours methotrexate - 2.5 mg (6 tablets weekly) prednisone - 5 mg 2x daily pantaprazole - 40 mg 2x daily, simponi aria injection every other month - l",none,rheumatoid arthritis diagnosed approximately 6 years ago,,none,"['Chills', 'Headache', 'Hypoaesthesia oral', 'Injection site pain', 'Migraine', 'Paraesthesia oral', 'Pharyngeal hypoaesthesia', 'Pharyngeal paraesthesia', 'Pruritus']",1,PFIZER\BIONTECH,IM 921084,NJ,23.0,M,"23 yo male received COVID-19 Moderna vaccine at 11:04am , patient monitored x15 minutes, no complaint or adverse reactions noted, discharged at 11:19pm Patient returned at 11:30am after going to his car, patient stated ""I went to my car and took a sip of coffee, I felt like there was something in my throat"". Monitored Patient x 45 minutes, patient alert and oriented x 4, calm, skin color normal, no rash, BP 125/86, P 84, pulse ox 98, no complaint of worsening or change in condition. Spoke with patient's father x 2, requested father to pick up son, but father felt not necessary. Notified medical advisor, recommended discharge to immediate care or ED via self. Parent agreed with self transport to ED after speaking with patient. 911 transport refused by patient. Safety instructions reviewed with parent and patient, both verbalized understanding. Patient discharged to transport self to Emergency Room, parent aware.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PUB,none,,,,none,['Sensation of foreign body'],1,MODERNA,IM 921085,PA,58.0,F,Patient broke out in a rash and was diagnosed with shingles,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,"Glimepiride, Metformin, Trulicity, Fenofibrate, Lopressor, Aspirin, Vitamin C, Vitamin B12, Vitamin D3, Calcium with Vitamin D",None,"Diabetes (type 2), Cancer, POTS",,Methylene blue,"['Herpes zoster', 'Rash']",1,MODERNA,IM 921086,IA,62.0,F,"Developed itching at site and then in 24 hrs red area 9sunburn appearing color approx. 4 inch diameter circle below the injection site, reddened area spread to part of deltoid and into antecubital at its maximum. used ice packs and Ibuprofen initially and then took 1 dose Benadryl on 3rd day which has helped subside the spread and caused fading from sunburn red to very light red color. itching milder",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/01/2021,6.0,OTH,"Ibuprofen, and Benadryl and ice packs",none known,none,,none known,"['Erythema', 'Injection site erythema', 'Injection site pruritus', 'Injection site urticaria']",1,MODERNA,SC 921087,TX,42.0,F,"Pt received COVID Vaccine at 1055, 1120 pt began coughing severely and could not stop, unable to speak. 1120 25mg Benadryl liquid given, Pepcid 20 mg given PO, cough worsening. 1122 second dose of Benadryl given, called for MD. Brought pt to Private room via wheelchair. Upon arrival, audible stridor noted. Epinephrine 0.3 mg IM given at 1126. IV started, placed patient on monitor and O2 via 1L NC. MD at bedside along with RT and pharmacy. 1134 Solumedrol 125 mg IV given, 1 puff of Ventolin given. Lungs clear. 1140 Coughing stopped, pt able to speak now. Vital signs: 1130 SPO2 99% Pulse 142 1135 99% pulse 106 BP 168/102 1140 sats 100% HR 93 BP 157/105 1145 sats 100% HR 97 BP 159/93 1200 sats 99% HR 103 155/97 114",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"lisinopril/HCTZ, albuterol MDI",no,asthma,,"ibuprofen, IV contrast allergy","['Cough', 'Speech disorder', 'Stridor']",1,PFIZER\BIONTECH,IM 921089,CO,45.0,F,"Began experiencing tachycardia, dizziness, headache, and started shaking about 5 minutes after receiving the vaccine. 50 mg Benadryl given IM to R deltoid at 1000. Symptoms began to resolve. Started experiencing some chest pain. Individual states she has a pacemaker, which felt like it was ""combating"" the tachycardia. Was monitored for 45 additional minutes and all symptoms subsided. Individual was able to return to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Humira (last taken on 1/3/21) and methotrexate (last taken 1/4/21).,None,"Sick Sinus Syndrome, Autoimmune Disease, Hemochromatosis. Also reports having COVID in July and has an MRI pending for cardiac complications related to COVID.",,Allergic to Penacillin.,"['Cardiac assistance device user', 'Cardiac pacemaker insertion', 'Chest pain', 'Dizziness', 'Tachycardia', 'Tremor']",UNK,MODERNA,IM 921090,MN,77.0,F,"Pt vaccinated on 12/23. PCP notified that SOB and fatigue getting worse on 1/4. Unable to keep pre-op Dental work planned prior to mitral valve surgery on 1/14/2021. PCP referred her to our ED where she was diagnosed with COVID-19 and transferred to facility, which is where her surgery was planned.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,12/23/2020,12/31/2020,8.0,PVT,"Apixaban, ECASA, Atorvastatin, Labetalol, Multivitamin w/minerals, Pantoprazole, Diltiazem, Meclizine",Mitral valve surgery (surgery planned within days),"HTN, GERD, A Fib, Sleep apnea on CPAP, Lactose intolerance, allergies",,Sulfa/Trimethoprim,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Brain natriuretic peptide increased', 'COVID-19', 'Dyspnoea', 'Fatigue', 'Fibrin D dimer increased', 'International normalised ratio decreased', 'SARS-CoV-2 test positive', 'Troponin increased']",1,PFIZER\BIONTECH,IM 921091,NH,54.0,M,"Pt received vaccination and left after 15 min. observation symptom free. He drove a short distance away from the clinical site when he felt profuse sweating and had syncope (seconds) crashing into curb. He was aroused from impact and was able to stop car. He then developed profuse nausea and sudden urge to defecate. He went to restroom. Given these events he returned to the clinical site in another vehicle. Upon arrival he denied chest pain, shortness of breath or ongoing nausea or abdominal pain. He reported his AM blood sugar was 72 and does not take insulin. No history of coronary disease or syncope. EMS was activated and assumed care.",Not Reported,,Not Reported,Yes,,Not Reported,U,12/31/2020,12/31/2020,0.0,PUB,none related,,diabetes,,neomycin,"['Defaecation urgency', 'Hyperhidrosis', 'Loss of consciousness', 'Nausea', 'Road traffic accident', 'Syncope']",UNK,MODERNA,IM 921092,VA,56.0,F,"Vertigo, nausea, vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,WRK,,,,,,"['Nausea', 'Vertigo', 'Vomiting']",1,PFIZER\BIONTECH,IM 921093,WA,56.0,F,"About 15 minutes after vaccination I started itching all over, became flushed, my throat and sore. I was taken to the ED where I was given non drowsy antihistamine and observed. At home I experienced severe fatigue, muscle aches and chills. At about 30 hours the symptoms went away",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,zoloft spirinolactone,no,,,none,"['Chills', 'Fatigue', 'Flushing', 'Myalgia', 'Oropharyngeal pain', 'Pruritus']",1,PFIZER\BIONTECH,IM 921094,TX,49.0,M,Vertigo starting at 7pm the night of the vaccine. The next morning woke with continued vertigo and fatigue. Still in bed on 1/5/2021 at 12:30pm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,none,none,none,,none,"['Fatigue', 'Vertigo']",1,PFIZER\BIONTECH,IM 921095,VA,51.0,F,"""Moderna COVID-19 vaccine EUA""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Multi- vitamins, glucosamine chondroitin",L arm injury- bicep strain (10/30),none,,Oxycodone,"['Laboratory test', 'Unevaluable event']",1,MODERNA,IM 921096,CA,,F,"Patient received the covid vaccine on 12/28/2020. c/o new onset of bil eyelid swelling with ""greenish"" discharge on 1/1/2021 and stomach pain (relieved with BM - ""little diarrhea"") on 1/2/2021. Diarrhea improved after 24 hours but the eye swelling persists. On 1/5/2021 new onset of headache, vomiting, ""wet"" cough, and nasal congestion. Denies fever, chills, or body ache. Covid test on 12/28/2020 was negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/01/2021,4.0,UNK,,,,,,"['Abdominal pain upper', 'Diarrhoea', 'Eye discharge', 'Eye swelling', 'Headache', 'Nasal congestion', 'Productive cough', 'SARS-CoV-2 test negative', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 921097,IA,28.0,F,"acute, mild but obvious, swelling of Right maxillary sinuses",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"trazodone, topimax, sertraline, zyrtec, loratadine, progesterone,",functional rhinoplasty,"migraines, seasonal allergies, ovarian cysts,",,"peanuts, shellfish",['Swelling'],2,MODERNA,IM 921098,CA,44.0,F,"FEVER, CHILLS, BODY ACHES, MALAISE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,SEN,,,,,,"['Chills', 'Malaise', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 921099,FL,38.0,F,"Fever up to 101, body aches, headache, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,OTH,"Cymbalta, propranolol, vitamin D, seroquel, clonazepam, rizatriptan, Fioricet",None,"Hypertension, chronic migraines, bipolar depression",,"Bactrim, seafood","['Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 921100,OR,65.0,F,"Patient had vaccine and about an hour later began experiencing symptoms of dizziness, light-headed, and ""woozy."" Was brought back to vaccine event by her manager. Was advised to go to the ED but refused.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,,,,,,['Dizziness'],UNK,MODERNA,IM 921102,VA,39.0,F,"Dizziness, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,WRK,,,,,,"['Dizziness', 'Headache']",UNK,PFIZER\BIONTECH,IM 921103,NY,41.0,M,central serous retinopathy have small blurry spot in right lower quadrant visual field,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/27/2020,4.0,PVT,none,none,none,,NKDA,"['Chorioretinopathy', 'Optical coherence tomography', 'Vision blurred', 'Visual field defect']",1,PFIZER\BIONTECH,IM 921104,CO,64.0,F,"About 5 minutes after receiving the vaccine, she began to experience a dry cough and tickling in the back of her throat. Also reported some shortness of breath. 25 mg of Benadryl was given IM in the R deltoid. Her symptoms subsided after approximately 15 minutes and she was able to return home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Antihypertensives and beta blocker,Reported that she was positive for COVID.,"Liver disease, hypertension, GERD, and arrythmias",,"Allergic to prilosec, iodine, eggs, sulfa, propofol, and metoprolol.","['Cough', 'Dyspnoea', 'Throat irritation']",UNK,MODERNA,IM 921105,NY,59.0,F,Woke up with redness to the left eye.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PVT,,,,,,['Ocular hyperaemia'],1,PFIZER\BIONTECH,IM 921107,HI,49.0,F,"On the evening of 01/04/2021, I developed hives at the site of the shot. (red welts) I took a Benadryl and went to bed. The swelling/hives went down the next morning, but it still feels itchy, thus I put hydrocortisone cream to see what happens.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,WRK,"Prolia, daily vitamins",None,None,,Pet dander,"['Injection site pruritus', 'Injection site swelling', 'Injection site urticaria', 'Urticaria']",1,MODERNA,IM 921108,NY,42.0,F,Tingling and numbness in left hand,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,"Centrum Multivitamin, CBD",,,,capers,"['Hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 921109,CA,46.0,F,"Left arm soreness and tenderness, onset approximately 6 hours after injection and lasting 4 days. Body muscle aches beginning about 6 hours after and progressing, lasting 3 days, but decreasing by day 2. Body chills beginning after about 11 hours and lasting for about 2 hours, resolving with Tylenol. Fever up to 101.1 beginning evening of injection and for full day following. General fatigue exacerbated day after injection and lasting 2 days(already experiencing some due to recent COVID infection). Mild nasal congestion day after injection and diminishing until resolved the day after beginning.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,PVT,"Levothyroxine, atorvastatin, allegra, pepcid, muti vitamin",COVID 19 positive with onset of 11/20/20 with some lingering symptoms,"hyperlipidemia, hypothyroidism",,"sulfa, neogram","['Chills', 'Fatigue', 'Myalgia', 'Nasal congestion', 'Pain', 'Pain in extremity', 'Pain of skin', 'Pyrexia']",1,MODERNA,IM 921110,IN,38.0,F,urticaria generalized and involving soft palate,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,lexapro and birth control,covid 2 months before,none,,none,"['Throat irritation', 'Urticaria']",1,PFIZER\BIONTECH,IM 921111,VA,52.0,F,"Nausea, lightheadedness, headache, fatigue, sore/swollen arm",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,WRK,,,,,,"['Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pain in extremity', 'Peripheral swelling']",1,PFIZER\BIONTECH,IM 921112,MS,32.0,M,"I got my first dose 12/18/20, minimal symptoms, sore arm that lasted about 24 hours, consistent with every years flu shot. 2nd dose 1/4/21, completely different experience. I was forwarned that the first dose primes the immune system, 2nd can be worse, so I was taking 600 mg Motrin q6 hours. Despite that, my arm progressively hurt worse and worse until now I can?t lift it above my waist. Full body aches and pains. Horrible chills and so cold. 102.1 F is highest temp so far, but that?s on top of scheduled Motrin. Still glad that I got it, but man does it suck right now.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Feeling cold', 'Mobility decreased', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 921113,CA,61.0,F,"Patient describes feeling feverish, joint aches in elbows and knees, body aches, red rash at knees and elbows and arm pain at injection sites. This is the 2nd dose, patient reports no adverse reactions on the first dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,,,,,,"['Arthralgia', 'Injection site pain', 'Pain', 'Pyrexia', 'Rash erythematous']",UNK,PFIZER\BIONTECH, 921114,TN,34.0,F,"No issue on date of vaccine. Minor muscle soreness in left arm the following day. No further issues following days. On 01/31/2020 at approximately 2130hrs, numbness and tingling of right side of face began while on work duty. Completed shift, drove home and went to bed. The following morning lips were covered in blisters, right cheek and under eye was extremely swollen. Attempted to drive to work and began experiencing brain fog and blurred vision. Returned home and facial swelling worsened along with severe headache and itchy dry skin. Took a bath and was unable to determine water temperature by touch. Intense leg muscle aches and nerve pain in right side of face. Remained calm and slept the following two days. Went to PCP as soon as possible on 01-04-2020 and was advised symptoms to be delayed adverse reaction to Moderna Vaccine. Patient was prescribed Alegra, Tylenol and methylprednisolone at this time. PCP advised inability to receive secondary dose on 01/28/2021 due to steroid treatment for allergic reaction to Moderna Vaccine. Swelling retreats and returns throughout the day following Dr visit. Voice changes occur during swelling (gurgled). The patient has no appetite but maintains a scheduled healthly diet. The patient has been unable to sleep for 24 hrs straight even after taking melatonin. There has been no shortness of breath however the patient experiences muscle spasms, dizziness and blurred vision while reading. The patient's right side of face has slower reaction timing than the left, the right eye closes frequently (not in tandum with the left) and is unable to smile. The patient has not experienced vomiting nor stool issues. The patient is unable to return to work until 01-11-2021 or until symptoms remain undetected for 48 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/31/2020,3.0,OTH,"Zinc40mg (daily), Melatonin 10mg(nightly), Concerta 36mg(daily)",None.,None,,None,"['Blister', 'Decreased appetite', 'Dizziness', 'Dry skin', 'Dysphonia', 'Eyelid function disorder', 'Facial pain', 'Facial paresis', 'Feeling abnormal', 'Headache', 'Hypoaesthesia', 'Impaired driving ability', 'Impaired work ability', 'Muscle spasms', 'Myalgia', 'Nervous system disorder', 'Neuralgia', 'Pain in extremity', 'Paraesthesia', 'Periorbital swelling', 'Pruritus', 'Sleep disorder', 'Swelling face', 'Vision blurred']",1,MODERNA,IM 921115,VA,45.0,F,I had flu like symptoms that lasted about 48 hours. I ran a fever of 102. The site of the vaccine on my left arm swelled up and wrapped all the way across my arm. Hot to the touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,"Avapro, Victosia, Levamir, Singular, Omepazole",,"Diabetes, Asthma",,Sulfa Drugs,"['Influenza like illness', 'Injection site swelling', 'Pyrexia', 'Skin warm']",1,MODERNA,IM 921116,KY,49.0,F,"Patient received Pfizer COVID vaccine and waited for 30 minutes after to observe for reaction. Within the 30 minute waiting period, she felt like her lips and tongue were tingling and her throat was scratchy. She denied shortness of breath, chest pain, difficulty swallowing or difficulty breathing. Vital signs were stable. Due to her history of anaphylaxis reaction with various medications and shellfish, she was taken to the ER. In the ER she received IV Solu-Medrol, Benadryl and Pepcid and her symptoms resolved. She was observed for 6 hours and then released to home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Unknown,Unknown,Unknown,,"Anaphylaxis to Codeine, Morphine, Penicillin, Sulfa, Shellfish","['Oropharyngeal discomfort', 'Paraesthesia oral']",1,PFIZER\BIONTECH, 921117,OH,36.0,F,"30 hours after injection, she had diffuse redness and itching in her left upper arm and forearm(ipsilateral arm of injection) that was also on her chest and abdomen. She has photos on her phone. Right hand felt numb. Interestingly, the symptoms spared approximately 10 cm around the injection site. She had mild joint diffusely. No fever but had chills. She took 25 mg of Benadryl and her symptoms significantly improved after about an hour.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,Dicyclomine prn,None,IBS,,None,"['Chills', 'Erythema', 'Hypoaesthesia', 'Pruritus']",1,MODERNA,SYR 921118,,57.0,F,Patient received her vaccination then started to feel palpitations as she was waiting for 15 minutes. Then the patient felt dizzy and her BP was elevated (SBP ~135 mmHg) than her normal which is around 90/60 mmHg.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Blood pressure increased', 'Dizziness', 'Palpitations']",1,PFIZER\BIONTECH,IM 921119,VA,36.0,F,Fever = 101.6F,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,,,,,,['Pyrexia'],1,PFIZER\BIONTECH,IM 921120,IA,56.0,F,"Head ache, Body Ache, Chills, Low grade fever, swollen on injection site, upset stomach",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,WRK,"Glipizide, metformin, multivitamins, Vitamin D3, Calcium, Fish oil",none,Diabetes,,Sonata for sleeping medication,"['Abdominal discomfort', 'Chills', 'Headache', 'Injection site swelling', 'Pain', 'Pyrexia']",1,MODERNA, 921121,MO,47.0,F,"fever 100.4 for 36 hrs, then today 1/5 hives on administration side (arm)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"OTC zyrtec, vitamin c vitamin B",none,none,"fever following pertussis vaccine, 11 years ago, lasted three days","gluten, wheat rye barley, pertussis vaccine, sulfa drugs.","['Pyrexia', 'Urticaria']",UNK,MODERNA, 921122,CA,47.0,F,Felt tired and cold Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/04/2021,4.0,UNK,,,,,,"['Fatigue', 'Feeling cold', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 921123,PA,50.0,F,"BP; 170/110 mild SOB palpitation (HR 80bpm) hot flashes mild sweating Took Claritin, increase fluid intake, and extra Valsartan x 1.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,Valsartan Calcium supplement,None,HTN,,Bactrim/Sulfa,"['Blood pressure increased', 'Dyspnoea', 'Hot flush', 'Hyperhidrosis', 'Palpitations']",1,PFIZER\BIONTECH,IM 921124,CA,67.0,F,"fatigue, chills, nausea, fever. Ibuprofen taken for fever. Fever lowered but it not go away for 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,PVT,zinc,"positive for covid December 2, 2020",none,,none,"['Chills', 'Fatigue', 'Nausea', 'Pyrexia']",1,MODERNA,IM 921125,TN,46.0,F,"24 hours post vaccination with headache, body aches and chills that lasted for around 48 hours. I developed a knot at the injections within 24 hours of receiving the injection and a knot in my lymph node under my right arm that was about the size of my thumb - pain at this site. 1/2/21 -9 days out from vaccination arm started itching at injection site, on 1/4/21 I noticed a large area of redness at the injections site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/04/2021,11.0,PVT,,none,none,,none,"['Axillary pain', 'Chills', 'Headache', 'Injection site erythema', 'Injection site nodule', 'Injection site pruritus', 'Lymphadenopathy', 'Pain']",UNK,MODERNA,IM 921126,NY,46.0,F,"Never pregnant, swelling and redness at injection site, Nausea in the morning, slight fever, no breathing difficulties, and weakness. Tylenol helped.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/05/2021,4.0,PVT,"Lisinopril 10mg, Qvair and Albuterol HFA, Zyzal, Vitamin C and women daily vitamin.",Hypertension on medication for it.,"Hypertension (3 years), Asthma, seasonal allergies, on medication (on going for over 10 years).",,"Seasonal Allergies, (weed, Mildew, pollen, dogs cats) mushroom, raw carrots, wheat, Kiwi, took allergy shots for two years weekly.","['Asthenia', 'Injection site erythema', 'Injection site swelling', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,IM 921127,CA,55.0,M,"REDNESS IN RT EYE, RUPTURE OF BLOOD VESSELS IN RT EYE. . USE EYE DROPS FOR ABOUT A WEEK AND IT RESOLVED IN ONE WEEK",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,WRK,,,,,,"['Eye haemorrhage', 'Ocular hyperaemia']",1,PFIZER\BIONTECH,IM 921128,TX,22.0,M,"large red circular reaction, very warm to touch at the site of the injection",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/05/2021,7.0,WRK,,,,,,"['Injection site erythema', 'Injection site reaction', 'Injection site warmth']",1,MODERNA,IM 921129,NY,36.0,F,"Pt received first dose at 11am. At 1108am patient reported feeling diaphoretic and shaky. Pt reported she did not eat bksft prior to coming. Blood sugar checked, result 98. Pt remained shaky, moved to private area and resting. Oxygen placed at 2L. Provider assessed patient with vital signs of 158/97, pulse 96, resp 22. Patient was given juice and crackers. Provider order for infusion of 500ml of normal saline. Post infusion, patient remained shaky, Provider order to send to ED for eval. EMS called.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,unknown,none noted,no,,unknown,"['Blood pressure increased', 'Heart rate increased', 'Hyperhidrosis', 'Tremor']",1,MODERNA,IM 921130,NY,47.0,F,"Erythema,itching and swelling at injection site, circumference of a medium apple slowly growing over time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,01/02/2021,7.0,UNK,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA, 921131,PA,42.0,F,Metallic taste,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,,,,,,['Dysgeusia'],UNK,MODERNA, 921132,MD,64.0,M,"We will treat this part as a burn, Silvadene cream twice daily until healed/drying. Also recommended nonstick bandages and we gave him several take home with him. Zyrtec 10 mg daily at bedtime for 2-4 weeks to help with the reaction",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,,,,,,['Thermal burn'],UNK,PFIZER\BIONTECH, 921134,PA,24.0,F,felt dizzy in the first 40 minutes. went away. 10 hours later began to experience body aches and vomiting.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,,no,no,,,"['Dizziness', 'Pain', 'Vomiting']",2,PFIZER\BIONTECH,IM 921135,FL,31.0,F,The next day I was feeling fatigue. My arm was sore & I had headaches. I did talk to a clinic virtually for my headaches.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,WRK,Lamictal 200 milligrams Trileptal 1200 mg,,,,No,"['Fatigue', 'Headache', 'Pain in extremity']",UNK,PFIZER\BIONTECH,IM 921136,OH,55.0,F,"INJECTION SITE- RED,WARM,SWOLLEN,SHINY AND SORE TO TOUCH, HIVES 7 DAYS AFTER THE VACCINE WAS GIVEN. CALLED DR AND REPORTED SYMPTOMS AND WAS PRESCRIBED BACTRIM AND TO CALL AND REPORT REACTION.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/03/2021,7.0,SEN,LISINOPRIL/HCTZ 10/12.5MG ESTRODIL 0.5MG PROTONIX 40MG LEXAPRO 20MG LORATADINE 20MG APPLE CIDER VITAMIN BENADRYL (DAY OF),NONE,HIGH BLOOD PRESSURE,"SAME REACTION FOR THE FLU SHOT, NOT AS SEVERE",NONE,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Urticaria']",1,MODERNA,IM 921137,CO,36.0,M,"Redness and swelling of upper right arm with itchy, red rash, and hives.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,PVT,Fluoxetine 80mg taken daily the morning of vaccination,None,None,,"No known allergies to medications, food, or other products","['Erythema', 'Peripheral swelling', 'Rash erythematous', 'Rash pruritic', 'Urticaria']",1,MODERNA,IM 921138,CO,32.0,F,"Noted pain in left axillary region the morning of 12/29/20 with adduction of arm. Self-examination revealed tender lymphadenopathy with size between 1-2cm. Mild itching around the injection site was noted the evening of 12/30/20. A small, irregularly shaped erythematous rash was noted around the injection site the morning of 12/31/20 - over about 24 hours this darkened to be tan/brown as compared to surrounding skin. There was gradual resolution of pain/tenderness, lymphadenopathy, and rash by approximately 1/1/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/29/2020,6.0,PVT,None,None,None,,None,"['Axillary pain', 'Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Lymphadenopathy']",1,MODERNA,IM 921139,IA,61.0,F,"Noticed some increased redness below injection site (at least 1-2 finger breadth) with itching and some discomfort beginning 12/31, increased on 1/1/21. Took tylenol 1000 mg and benadryl 25 mg x one dose. Redness improved over time, still note some slight itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,WRK,"Noticed some increased redness below injection site with itching and some discomfort beginning 12/31, increased on 1/1/21. Took tylenol 1000 mg and benadryl 25 mg x one dose. Redness improved over time, still note some slight itching.",None,Asthma,,Animal dander,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,IM 921140,CA,51.0,F,1st Moderna Vaccine given on Left Arm one week ago. Arm is now red in a red area that is 4x4 inches and hot to the touch. It is slightly painful to the touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,WRK,birth control pills; allertec otc meds from pharmacy; sertraline; topiramate,covid within one month prior,obesity,,penicillin and sulfur,"['Erythema', 'Pain in extremity', 'Skin warm']",1,MODERNA,IM 921141,WA,50.0,M,"Injection was painless. Within 5 minutes of vaccine felt dizzy and had heart rate into the 120's. Duration approximately 5 minutes then tachycardia and dizziness resolved. Also had a tremor. No angioedema, urticaria or other skin/mucosal findings. Was not anxious. Arrived home and wife and children told me I looked flushed and noticed my pupils were significantly dilated. The flushing and dilated pupils resolved over the next hour. No shortness of breath or hoarse voice of any kind however my mouth felt extremely dry. I did not do anything for treatment. Spontaneous resolution.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"fish oil, vitamin d",None,Seasonal allergies,,None,"['Dizziness', 'Flushing', 'Heart rate increased', 'Mydriasis', 'Tachycardia', 'Tremor']",1,MODERNA,IM 921142,PA,38.0,F,"In first few days after vaccination experienced arm pain, headaches and body aches. All symptoms subsided by day 7. On day 10 (12.31) began to again experience arm pain and new rash over injection site. Pain spread to opposite arm and then became generalized. Pain worse in armpits. Rash turned into raised bullseye over injection site prompting MD visit. COVID tested completed and was negative blood work sent and is pending. I was started on Pepcid/benedrly and doxycycline.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/31/2020,10.0,PVT,"cetirizine, Vitamin D, B12, Fluticasone, Minastrin 24",b12/vit D deficiency,morbid obesity,,"strawberries, percocet","['Axillary pain', 'Blood test', 'Headache', 'Injection site erythema', 'Injection site rash', 'Pain', 'Pain in extremity', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,SYR 921144,IL,49.0,F,"Arm pain days 1st few days...now gone.., armpit pain/tenderness/swollen feeling day 5(1/6/21) after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/04/2021,5.0,PVT,"Vitamin D, Stress B Complex, Resveratrol, Docusate sodium",None,None,,None,"['Axillary pain', 'Localised infection', 'Swelling', 'Tenderness']",1,MODERNA,SYR 921145,MN,42.0,F,"Fever- Highest was 100.8, this was the following morning after receiving vaccine 1/1/2021. Injection site was extremely sore and swollen, to the point I could not even touch the area. This was the left deltoid. Extreme fatigue, I was in bed the entire day sleeping on and off. Overall muscle pain as well. on 1/2/2021 I was feeling much better, my arm was almost completely improved. Only mild soreness, and only a low grade temp of 99.6. Since then, on day 5, I seem to have some dizziness but it is goes away quickly.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,"Methocarbamol, Drospirenone-ethinyl estradiol, Montelukast, Trazodone",None,Asthma,,Sulfa,"['Dizziness', 'Fatigue', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Pyrexia', 'Somnolence']",1,MODERNA,IM 921146,PA,50.0,F,"2 days later, noted patches of bruising in the right lower leg near ankle, posterior calf, lateral calf, left lower leg in the medial aspect, right tibial tubercle area, left medial knee, right distal forearm, left wrist underneath her watch, posterior olecranon processes, posterior proximal humerus bilaterally. No bruises in the trunk, back, face or neck. She started Plavix treatment with Cardiologist 12/28/20. Cardiologist, Hospital physician.approved her to get the COVID vaccine. She will call her Cardiologist and let us know what course of action resulted. She could just be bruising from mild trauma that she is unaware of since Plavix is a new med for her. States she does cross her legs when she sits and leans on her elbows. Shoulder bruising seems to be where she lays when in bed.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/01/2021,2.0,PVT,"Plavix 75mg, ASA 81mg, Lipitor10 mg, Synthroid 75 mcg","Lipitor is for PFO enclosure, hypothyroidism",,,Amoxicillin,['Contusion'],1,PFIZER\BIONTECH,IM 921147,PR,40.0,F,"Headache, nausea, metalic taste, general malaise, low back pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,None,None,None,,Cassava,"['Back pain', 'Dysgeusia', 'Headache', 'Malaise', 'Nausea']",2,PFIZER\BIONTECH,IM 921148,GA,23.0,F,"Fever 101F, dry cough,nasal congestion,, resolved within 4 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/21/2020,2.0,PVT,Ibuprofen,none,none,,seasonal,"['Cough', 'Nasal congestion', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 921149,CO,38.0,F,"Received vaccine on 1/4/21 at 12:50. On 1/5/21 at 3:00 called nurse line to report fever of 101.8, chills, cough, dizzy with standing.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,Unknown,unknown,unknown,,unknown,"['Chills', 'Cough', 'Dizziness', 'Pyrexia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,IM 921150,OH,26.0,F,"Moderna COVID-19 Vaccine EUA, Injection Site pain, headache, body aches, dizziness, light headed. Still having symptoms since they just started this morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Loratadine 10mg tablet, Famotidine 20mg tablet, Great-Flex Formula-36, Vitamin D3 2000 IU, Vitamin B12 5000mcg",None,"Chronic headaches, Tested positive for COVID-19 on November 3,2020.",,"Seasonal allergies, Sulfa drugs","['Dizziness', 'Headache', 'Injection site pain', 'Pain']",1,MODERNA,SYR 921151,NY,43.0,F,"The resident who was known to have seizures, and under control for many yeas with Keppra 1000 mg twice a day, on the second day after vaccination developed recurrent seizures requiring hospitalization to an intensive care unit, with intubation and mechanical ventilation until 1/5/21 (to be extubated today). She is still at the hospital.",Not Reported,,Not Reported,Yes,6.0,Not Reported,U,12/28/2020,12/29/2020,1.0,SEN,None,HIV DM HTN Seizure d/o Schizoaffective d/o Lipid d/o,As above,,"Penicillin, Bactrim, Dapsone","['Blood HIV RNA below assay limit', 'CD4 lymphocyte percentage decreased', 'Condition aggravated', 'Endotracheal intubation', 'Intensive care', 'Mechanical ventilation', 'Seizure']",1,PFIZER\BIONTECH,IM 921152,CO,51.0,M,12hrs after vaccination I got chills and muscle aches and headache that necessitated remaining in bed for the next 16hrs. All of my colleagues that had previously had covid and then got vaccinated suffered similar SEs,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/21/2020,1.0,PVT,not avl to this reporter,not avl to this reporter,prior covid infection,,nka,"['Chills', 'Myalgia']",1,PFIZER\BIONTECH, 921154,CA,40.0,M,"Initially patient felt warmth on top of head and around eyes and ears 20 minutes later experienced fuzzy vision, pain in back of right eye Warmth on top of head and around ears has gone away as well as fuzziness but patient is still feeling consistent pain behind right eye",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Eye pain', 'Feeling hot', 'Vision blurred']",1,MODERNA,SYR 921156,TX,46.0,F,"NUMBNESS TO TONGUE 10-15 MINUTES AFTER VACCINE, FEW HOURS LATER MOUTH NOT CLOSING ALL THE WAY FELT NUMB, THEN STARTED WITH LEFT EYE NOT BLINKING AND LEFT EYE TEARING",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PUB,Metformin and one more medication for diabetes and two medications for high blood pressure,none,DIABETES AND HIGH BLOOD PRESSURE,,none,"['Corneal reflex decreased', 'Hypoaesthesia oral', 'Lacrimation increased']",1,MODERNA,IM 921157,AL,20.0,F,Flushing on arms and chest for about 15 minutes,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,none,none,none,,"Morphine, sulfa, oranges",['Flushing'],1,PFIZER\BIONTECH,IM 921159,ND,40.0,M,Patient reports dizzy spell that lasted about 5-10 min aproximately one hour after immunization.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,['Dizziness'],1,MODERNA,IM 921160,,39.0,F,"Sore arm on going, extreme fatigue, light headache, could not get comfortable, body aches and chills lasting 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,MIL,"Xanax, beta blocker, allergy pill",No,"Bell's palsy, sleep apnea, sinus tachycardia",,Codiene,"['Chills', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Pain', 'Pain in extremity']",1,MODERNA,SYR 921161,NY,58.0,F,Fever of 101.8,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,,,,,,['Pyrexia'],1,MODERNA,IM 921162,CT,28.0,F,Tachycardia - onset 1/4 9pm lasting - present HR range from 90-105 Chest tightness - intermittent over last 12 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PUB,Multi vitamin Vitamin D Junel FE Birth control,None,None,,None known,"['Chest discomfort', 'Heart rate increased', 'Tachycardia']",1,MODERNA,IM 921164,NY,54.0,F,chills fever muscles pain joint pain headache arm pain difficulty of breathing weakness dizziness fatigue tiredness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,,migraine,migraine,,kiwi,"['Arthralgia', 'Asthenia', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 921165,PA,70.0,F,"Patient woke up at 4 am with chills, fever, nausea. Patient recovered by that Saturday.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Metformin, Linsinopril",no,"diabetic , hypertension",,no,"['Chills', 'Nausea', 'Pyrexia']",1,MODERNA,IM 921166,ND,40.0,M,Experienced dizzy spell lasting 5-10 minutes approximately one hour after immunization,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,['Dizziness'],1,MODERNA,IM 921167,OH,42.0,F,"Swelling on right side of face, tingling, numbness up to Right eye and into Right side of neck (started 1/4 - lasted approximately 10 hours)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/04/2021,5.0,SEN,,,,,,"['Hypoaesthesia', 'Hypoaesthesia eye', 'Paraesthesia', 'Swelling face']",1,PFIZER\BIONTECH,IM 921168,OH,27.0,F,"swollen lymph node in right arm pit area nickel size, noticed evening of 1/4",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/04/2021,5.0,PVT,,,,,,['Lymphadenopathy'],1,MODERNA,SYR 921169,UT,41.0,F,"Extreme Pain in the right shoulder and arm. Fatigue, joint pain, nausea and dizziness was felt the morning after the first dose. Redness at and around the injection site began aroungd 72 hours after injection. A hard lump an swelling appeared that day that was about baseball size.A rash appeared as a hives like appearance that migrated down the arm and eventually stopped around the antecubital area. Redness persists at the site of injection that is about the size of a grapefruit today which is 6 days later. Pain was treated with ibuprofen and has improved but is still present. Itching and burning sensation at the bicep persists.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,"Levothyroxine, omeprazole,",none,"Hypothyroid, vestibular migraines",,none,"['Arthralgia', 'Burning sensation', 'Dizziness', 'Fatigue', 'Injection site erythema', 'Mass', 'Nausea', 'Pain in extremity', 'Pruritus', 'Rash', 'Swelling', 'Urticaria']",1,MODERNA,IM 921170,CT,61.0,F,Developed itching on right side of face between temple and earlobe while driving home. Once home was noted to have 3 dime sized hives in that area which lasted approximately 2 hours and then resolved without intervention or further adverse event.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,none,none,psoriasis,,Ceftin; purple clover,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 921171,VA,42.0,F,"RECEIVED VACCINE ON 12/22; ON 12/24, STARTED FEELING WEAK AND HAVING GI ISSUES WITH DIARRHEA. ON 12/27, STARTED HAVING SHORTNESS OF BREATH AND WHEEZING MORETHAN HER NORMAL WITH HER ASTHMA ILLNESS AND CAME TO ER. WAS TESTED AND FOUND TO BE COVID POSITIVE.",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,12/22/2020,12/24/2020,2.0,PVT,"Famotidine, albuterol inhaler, xopenex",Asthma,asthma,,aspirin,"['Asthenia', 'Asthma', 'COVID-19 pneumonia', 'Computerised tomogram thorax abnormal', 'Condition aggravated', 'Diarrhoea', 'Dyspnoea', 'Gastrointestinal disorder', 'Lung consolidation', 'Lung opacity', 'PO2 decreased', 'SARS-CoV-2 test positive', 'Wheezing']",1,MODERNA,IM 921172,MA,27.0,F,"FLU like symptoms - sore throat, body aches, nausea, vomitting",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/25/2020,1.0,PVT,Alyacen 1/35 Ondansetron HCl 8mg,None known,Endometriosis IBS,,Amoxicillin-Hives,"['Influenza like illness', 'Nausea', 'Oropharyngeal pain', 'Pain', 'SARS-CoV-2 test negative', 'Vomiting']",1,MODERNA,IM 921173,MA,,M,1/1 I started having metallic taste in my mouth. 1/2 I noticed the left side of my face was drooping. 1/3 It was worse so I spoke with a a co worker who is a paramedic who told me to go to the ER. I went to ER and they diagnosed me with Bells Palsy.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,OTH,"eloquis 5mg, HCTZ 25mg, astrovastin 45mg, metformin, Keppa 500mg, metropolol 25mg, VIte B12/ 6, fish oil Medication prescribed 1/3/21: predisone 20mg valacyclovir 500mg",no,"seizure 2017 pneumonia, blood clots a fib 2018",shingles vaccine 2017 diagnosed with shingles following day.,penicillin,"['Blood test', 'Dysgeusia', 'Facial paralysis', 'Magnetic resonance imaging']",1,MODERNA,SYR 921174,WA,51.0,F,"hives over face, neck,chest and upper arms. Took benadryl and it resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/04/2021,5.0,PVT,"levothyroxine, liothyronine, allegra, singulair, atrovent, estrodial",,"asthma, hypothyroidism, allergies",,"flovent, flonase, latex, avocado, watermelon, mango",['Urticaria'],1,MODERNA,IM 921175,NJ,77.0,F,"Resident received Covid Vaccine, noted after 30 mins with labored breathing BP 161/77, HR 116, R 38, T 101.4,",Yes,01/05/2021,Not Reported,Yes,,Not Reported,N,01/03/2021,01/03/2021,0.0,SEN,,"CHF, COPD, DM, heart failure, anemia, sleep apnea","CHF, COPD, DM, heart failure, anemia, sleep apnea",,NKA,"['Body temperature increased', 'Dyspnoea']",1,PFIZER\BIONTECH,IM 921176,MN,52.0,M,Left shoulder/upper arm pain and weakness in arm and hand. Approximately 21 hours at this time.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,SEN,"Testosterone, lansoprazole, famotidine.",Sinus infection,"COPD, Hypoglycemia.",,Maple trees,"['Arthralgia', 'Muscular weakness', 'Pain in extremity']",UNK,MODERNA,SYR 921177,CO,53.0,F,"This RN received the COVID 19 vaccine 12-17-2020 at 1730 . Called manager at 1040 to report nausea, vomiting and terrible headache. No fever noted.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,not avl to this reporter,not avl to this reporter,not avl to this reporter,,not avl to this reporter,"['Headache', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH, 921178,MO,40.0,F,"At approx 7:00 in evening patient developed itching and noticed her back right side was covered in hives and a rash, she also then developed lymphedema down her right leg and up into her armpit on the right side. She also reports having a fever of 101, joint/muscle pain, and charlie horses.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PUB,,none,unknown,,unknown,"['Arthralgia', 'Lymphoedema', 'Muscle spasms', 'Myalgia', 'Pruritus', 'Pyrexia', 'Rash', 'Ultrasound Doppler normal', 'Urticaria']",1,MODERNA,IM 921179,TN,34.0,F,"Dizzy, headache, felt faint, high HR, felt off - few episodes for about 30 min after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,,,,,,"['Dizziness', 'Electrocardiogram', 'Feeling abnormal', 'Headache', 'Heart rate increased']",1,PFIZER\BIONTECH,IM 921180,CA,45.0,M,"Patient reports pain at injection site and about an hour later he reports not being able to move his arm at all, especially upward.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,WRK,Tylenol,,,,,"['Injection site pain', 'Musculoskeletal disorder']",UNK,MODERNA, 921181,WA,26.0,F,"woke up in middle of the night (around 1 AM) due to intense pain in injection site. Took advil and went back to bed. Woke up in the morning with extreme headache and neck pain as well as pain in injection site. Took tylenol which did not help the pain or headache. Headache worsened until about noon, at which point I could not move due to neck/arm pain and headache. Symptoms dissipated quickly away pretty quickly around 1 PM",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,PVT,"Bupropion, Monolinyah, Allertec,",none,asthma,,"Dust, dogs, cats, mold, Fluconazole","['Headache', 'Injection site pain', 'Mobility decreased', 'Neck pain', 'Sleep disorder']",2,MODERNA,IM 921182,NE,60.0,M,"SVT, significant palpitations, Shortness of breath",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,Lisinopril Calcitrol Urolic Lexapro Sodium Bicarb,Gout,Polycystic Kidney disease Prostate CA,,NKA,"['Cardiac monitoring', 'Dyspnoea', 'Laboratory test', 'Palpitations', 'Supraventricular tachycardia']",1,PFIZER\BIONTECH,IM 921214,,,M,"Hives completely covered his body; Face ears lips eyes swelled shut; ears lips eyes swelled shut; lips eyes swelled shut; eyes swelled shut; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and an unknown time after starting Cortison, the patient experienced hives, facial swelling, ear swelling, lip swelling and eye swelling. The patient was treated with cortisone acetate (Cortison) and steroid shot (nos). On an unknown date, the outcome of the hives, facial swelling, ear swelling, lip swelling and eye swelling were unknown. It was unknown if the reporter considered the hives, facial swelling, ear swelling, lip swelling and eye swelling to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The case was reported by patient's parent. The reporter mention the the patient had a severe reaction to the Flu shot. The patient experienced face, ear, lips and eyes swelled shut and had hives completely covered the body. The patient god shot or cortisone and steroids. The reporter said that the vaccines should not be pushed on people like the Flu vaccine was pushed on me. The reporter said no but they insisted and was persistent. The reporter said that see what happens when you did not listen to yourself and trust in god. No other information was provided. The reporter did not consent to follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Ear swelling', 'Eye swelling', 'Lip swelling', 'Swelling face', 'Urticaria', 'Vaccination complication']",UNK,UNKNOWN MANUFACTURER, 921215,,,F,"Life threatening circumstances; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a female patient who received DTP (A or W not known) (DTP (A or W not known)) for prophylaxis. On an unknown date, the patient received the 1st dose of DTP (A or W not known). On an unknown date, unknown after receiving DTP (A or W not known), the patient experienced adverse event (serious criteria life threatening). On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to DTP (A or W not known). Additional details were provided as follows: The reporter was patient's parent. The age at vaccination was not reported. The patient had life threatening circumstances following her 1st dose of DTP vaccine and her pediatrician said it would become a fatal event if she ever received the ""P"" part of the vaccine again. This case is 1 of the 4 cases reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR254860:Same reporter US-GLAXOSMITHKLINE-US2020AMR254861:Same reporter US-GLAXOSMITHKLINE-US2020AMR254863:Same reporter",Not Reported,,Yes,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Adverse event'],1,UNKNOWN MANUFACTURER, 921221,,,U,"eye and mouth swelling; eye and mouth swelling; injection site pain; unable to think straight; low energy; sweats; mild diarrhea; Chills; headache; bodyache; cough; dry throat; This is a spontaneous report from a non-contactable Other HCP reported that an adult patient receives first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot/Batch Number and Expiration Date unknown) intramuscularly on 25Dec2020 at single dose for covid-19 immunization. The patient's medical history included allergies to Pollen/dust, extreme weather. The concomitant medications were not reported. The patient experienced Chills, sweats, headache, bodyache, cough, dry throat, eye and mouth swelling (after 24 hours), injection site pain, unable to think straight, low energy, mild diarrhea. Adverse event start date: 25Dec2020. The patient been tested for COVID-19 and no COVID-19 prior vaccination. There is other vaccine in four weeks. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/25/2020,12/25/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Dust allergy; Pollen allergy; Sensitivity to weather change,,,"['Asthenia', 'Chills', 'Cognitive disorder', 'Cough', 'Diarrhoea', 'Dry throat', 'Eye swelling', 'Headache', 'Hyperhidrosis', 'Mouth swelling', 'Pain', 'SARS-CoV-2 antibody test', 'Vaccination site pain']",1,PFIZER\BIONTECH, 921222,MD,60.0,F,"Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown. The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have ""little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe."" Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times.""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/01/2020,,UNK,CRESTOR,,Medical History/Concurrent Conditions: Hypercholesterolemia,,,"['Abdominal discomfort', 'Asthenia', 'Diarrhoea', 'Dyspnoea', 'Eating disorder', 'Glossodynia', 'Muscle spasms', 'Oropharyngeal pain', 'Pain', 'Palpitations', 'Tongue discomfort', 'Vomiting']",UNK,PFIZER\BIONTECH, 921224,TX,23.0,F,"nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received bnt162b2 (BNT162B2 reported as Covid 19 vaccine or Pfizer-Biontech Covid-19 Vaccine; lot number: EL0140; expiration date: Mar2021), via an unspecified route of administration on 29Dec2020 08:15 at single dose for Covid-19 vaccination. The patient has no medical history. Concomitant medication includes unspecified birth control pills. The patient reported that she got the vaccine this morning and about maybe 30-45 min after getting the vaccine, she started being nauseous and vomiting. She doesn't have a prescribing doctor. She vomited 15 minutes ago. She has vomited 2-3 times in the last hour. She is trying to drink sprite and crackers to settle her stomach, but it is still there. She is not taking any other medication. She does take birth control but doesn't think it is pertinent. She is calling to see what she should do for symptom management and how long these side effects will last for. She mentioned that vomiting started after nausea. The patient reported that her employer does not believe she is having side effects. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Nausea', 'Vomiting']",1,PFIZER\BIONTECH, 921225,,37.0,M,"muscle pain; joint pain; severe chills; headache; nausea; This is a spontaneous report from a contactable other hcp (patient). A 37-year-old male patient received bnt162b2 (lot number: EL1284), via an unspecified route of administration at left arm, first dose on 24Dec2020 11:15, at single dose, for COVID-19 immunization. No relevant Medical history. No known allergies to medications, food, or other products. No concomitant medication was received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Age at vaccination was 37 years old. The patient experienced muscle pain, joint pain, severe chills, headache, nausea on 28Dec2020 14:00. No treatment was received for the adverse event. The events were reported as non-serious. Outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/28/2020,4.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Nausea']",1,PFIZER\BIONTECH, 921226,MN,,M,"worsening muscle aches; pains; joint site symptoms; This is a spontaneous report from a contactable physician (patient). A 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history included muscle aches. Concomitant medications were not reported. He usually takes an anti inflammatory for muscle aches but decided to hold it prior to receiving the first dose of the vaccine. After getting the vaccine, he started to experience worsening muscle aches, pains, and joint site symptoms. He thinks nothing was out of the ordinary. He get these symptoms any time he receive a vaccine. Outcome of the events was unknown. The following information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PVT,,,Medical History/Concurrent Conditions: Muscle ache,,,"['Arthropathy', 'Myalgia', 'Pain']",1,PFIZER\BIONTECH, 921227,,,M,"This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 24Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is a male nursing student. He received COVID vaccine 24Dec2020 and then realized he wasn't going to be available to receive the second dose at his facility until 26Jan2021 and was wondering if it would be too long to wait. He also reported he had a reaction to the 1st dose, a ""tiny headache off and on, chills, low energy on 25Dec2020"" all of which resolved within approximately 30 hours. He had also heard that the 2nd dose has ""worse side effects"". The outcome of events tiny headache off and on, chills and low energy was recovered in Dec2020. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,UNK,,,,,,"['Asthenia', 'Chills', 'Headache']",1,PFIZER\BIONTECH,OT 921228,VA,77.0,M,"vomited; nausea/ felt sick to his stomach; felt woozy; didn't feel well; right deltoid soreness; This is a spontaneous report from a contactable physician (patient). A 77-years-old male patient received the first dose of BNT162B2 (Lot: EH9899), via an unspecified route of administration in deltoid right, on 24Dec2020 11:30 at single dose for COVID -19 immunization. Medical history included pulmonary embolism half a dozen years ago. He has had no problems with Deep Vein Thrombosis or pulmonary emboli since then, since half a dozen years. He has had a battery of lab tests 2 months ago, his blood glucose was high, it was 106 mg. The potassium was ok. He has had no issues with vaccines in the past. He had an antibody test last Jul2020 because he had bacterial lower urinary tract prostate infection. Concomitant medication included rivaroxaban (XARELTO) at 10 mg a day and cefalexin sodium (CEPHALEXIN) at 500 mg three times a day, well approximately 3, sometimes he forget a dose. The physician reported possible side effects of Covid vaccine. The physician received the vaccine on 24Dec2020 at 11:30 in the late morning and felt fine. He woke up on 25Dec2020 and at 2:30AM he was sick to his stomach and vomited and didn't feel well the rest of the day. Since then he had been okay, he had occasional nausea and vomiting. He clarified that on 24Dec2020, in the late evening, his appetite which was usual, was robust. Then on 25Dec2020 at 2:30 in the morning he vomited, and had no trouble since then. From what he read, nausea and vomiting are observed following the injection. On 24Dec2020 just before bed, he had a light supper, his appetite was robust, then unexpectedly he woke up sick to his stomach and went back to bed on 25Dec2020. He clarified that he had not vomited since the one episode on 25Dec2020. He also added that he has not been nauseous since then. Caller also added that he felt a little woozy on Holiday 25Dec2020, it only lasted up until the evening of 25Dec2020. He had the 1 episode vomiting on 25Dec2020 and felt woozy until late evening of 25Dec2020. His right deltoid where he received the vaccine was a little bit sore on 24Dec2020, and he was still having a little bit of soreness, it is slight, not very tender, he is unable to do usual morning exercises with out noticing the discomfort, the exercise he is doing is chin ups, the soreness is not intense and it never was. The lab test in 2020 included Height: under 5 feet 5 inches. Weight: about 165lbs or 167lbs. He had no positive test for COVID prior to the vaccine. All the tests were negative. The 1st one was nasopharyngeal, and all the next ones after were nasal swabs. He thought they are all reverse transcriptase tests. The last time he had a COVID test they did a nasal swab, it was this morning, and before that was last Monday or Tuesday, but he thought more so Monday. He had one PCR test. The outcome of the events vomited, nausea and felt woozy was recovered on 25Dec2020. The outcome of the event right deltoid soreness was recovering. The outcome of the other event was unknown. The 2nd dose for Covid vaccine was schedule for 14Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,UNK,XARELTO; CEPHALEXIN [CEFALEXIN SODIUM],,Medical History/Concurrent Conditions: Blood glucose increased (106 mg); Prostate infection (had an antibody test Last Jul2020 because he had bacterial lower urinary tract prostate infection); Pulmonary embolism (half a dozen years ago),,,"['Antibody test', 'Blood glucose', 'Blood potassium', 'Body height', 'Dizziness', 'Malaise', 'Nausea', 'SARS-CoV-2 test', 'Vaccination site pain', 'Vomiting', 'Weight']",1,PFIZER\BIONTECH, 921229,PA,,F,"injection site was itchy, red, warm, and firm; injection site was itchy, red, warm, and firm; injection site was itchy, red, warm, and firm; injection site was itchy, red, warm, and firm; pain under her left arm near her left breast; very sore arm; This is a spontaneous report from a contactable nurse (patient herself). A 33-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EJ1685, expiration date: unknown), intramuscularly on the left arm on 21Dec2020 at 12:00 PM at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. The patient had no known allergies; there were no allergies to medications, food, or other products. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On the first (1st) day after vaccine (22Dec2020), the patient experienced very sore arm, but no other effects until the 8th day after vaccine. On 28Dec2020 at 08:00, the patient started with pain under her left arm near her left breast. On 29Dec2020, the injection site was itchy, red, warm, and firm. The reporter assessed the events as non-serious. The patient did not receive any treatment for all the events. The patient was not recovered from the events ""very sore arm, pain under her left arm near her left breast, and injection site was itchy, red, warm, and firm.""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/22/2020,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Pain in extremity', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site pruritus', 'Vaccination site reaction', 'Vaccination site warmth']",1,PFIZER\BIONTECH,OT 921230,,,F,"pain in the administration site; tired; feeling dehydrated; had a low degree fever; her nostrils were stuffed or clogged.; pain in the arm; went to sleep 3 hours earlier than usually did, waking up five hour later; feeling like that was about to had flu; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is 1st of 2 reports. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid 19 vaccination. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2. The patient reported that she experienced a few symptoms after the administration of the second dose of the Pfizer's COVID-19 vaccine. The consumer reported that she was in observation for 30 minutes after she was administered with the second dose of the Pfizer's COVID-19 vaccine and she felt only pain in the administration site. Then at night she felt really tired and she went to sleep 3 hours earlier than she usually does, waking up five hour later with pain in the arm and feeling dehydrated and with the need of sugar, also feeling like she was about to had flu. The patient measured her temperature and she reported that she had a low degree fever but maybe the thermometer was malfunctioning, also she noticed that her nostrils were stuffed or clogged. The consumer reported that today on 29Dec2020 in the morning she woke up feeling much better and with one nostril unclogged. The consumer reported that the same symptoms were experienced by a friend of hers after the administration of the second dose of the Pfizer's COVID-19 vaccine. The outcome of the events was recovering. Information on the lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020519005 same reporter and drug and AE, different patient;US-PFIZER INC-2020519005 Same Reporter and Drug/Diffrent Patient",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Body temperature', 'Dehydration', 'Fatigue', 'Hypersomnia', 'Influenza like illness', 'Nasal congestion', 'Pain in extremity', 'Pyrexia', 'Vaccination site pain']",2,PFIZER\BIONTECH, 921231,,,F,"lower back pain bilaterally; This is a spontaneous report from a contactable other healthcare professional. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced lower back pain bilaterally on 28Dec2020. She mentioned she didn't lift anything heavy or do anything since yesterday to cause the lower back pain. She clarified the pain started in her lower back and spread bilaterally. She asked if lower back pain is a common side effect of the COVID-19 Vaccine. She said she has never had lower back pain like that before. Event outcome was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,UNK,,,,,,['Back pain'],UNK,PFIZER\BIONTECH, 921232,AZ,23.0,M,"light headed; heart was racing; itchy in one part of my right arm (back of the shoulder)/Itching like all over my body; abdomen were itchy and bumps/rashes and some bumps in my body; some rashes; it is like an allergy/like the allergic reaction the medication that causes it; This is a spontaneous report from a contactable Nurse reporting for himself. A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left deltoid on 28Dec2020 15:00 at single dose for prevention for Covid-19. The patient medical history included electrolyte imbalance. Concomitant medications included ascorbic acid, rosa canina (VITAMIN C WITH ROSE HIPS), zinc, vitamin D3, all started from Dec2020 (18 or 19Dec2020) and ongoing for ""immune system"". At 3pm yesterday (28Dec2020) he received the vaccine. He experienced feeling light headed and his heart was racing a minute after receiving the vaccine. Around 11-12pm he was itching on his arm, abdomen and back. He took an allergy pill and rubbed hydrocortisone cream on his back, arm and armpit. After taking the medication and rubbing the cream the bumps went down 30 minutes to an hour later. He woke today and everything was clearing. These symptoms usually hit him from having an electrolyte imbalance. He had missed the past 2 doses of Vitamin C, Zinc and Vitamin D3. He had 2 Covid test prior to getting the vaccine. His height was 6 feet 3 or 6 feet 4. He started like itching like all over his body. He noticed some rashes and some bumps in his body, it was like an allergy. He was just wondering if this was like the allergic reaction the medication that causes it. The outcome of the events light headed and heart was racing was recovered on 28Dec2020 15:01 and the outcome of the other events was recovered on an unknown date in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,VITAMIN C WITH ROSE HIPS [ASCORBIC ACID;ROSA CANINA]; ; VITAMIN D3,,Medical History/Concurrent Conditions: Electrolyte imbalance,,,"['Allergy to vaccine', 'Body height', 'Dizziness', 'Palpitations', 'Pruritus', 'Rash', 'SARS-CoV-2 test', 'Skin disorder']",UNK,PFIZER\BIONTECH, 921233,FL,23.0,F,"Fever -102; Chills; Headache; Left arm pain and swelling; Left arm pain and swelling; General body aches; Nausea; Tired; Unwell; Dizzy; This is a spontaneous report from a contactable other HCP (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number E49899) (Brand: Pfizer), via an unspecified route of administration at 28Dec2020 15:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The patient medical history and concomitant medications were not reported. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever -102, chills, headache, left arm pain and swelling, general body aches, nausea, tired, unwell, dizzy at 29Dec2020 11:00 AM. It's unknown if patient received treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered. The events were reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PUB,,,,,,"['Body temperature', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Malaise', 'Nausea', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",1,PFIZER\BIONTECH, 921234,NM,55.0,F,"Tiredness; sleepy; headache; malaise; This is a spontaneous report from a contactable Other HCP (patient). A 55-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in arm Left on 16Dec2020 12:45 at single dose for COVID-19 immunisation. Medical history included none. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced tiredness, sleepy, headache, malaise on 16Dec2020 16:00. The patient underwent lab tests and procedures which included Nasal Swab: negative on unknown date in Dec2020. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has been tested for COVID-19. No treatment received for the adverse event. Case was non-serious. The outcome of events was recovered in Dec2020. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Fatigue', 'Headache', 'Malaise', 'SARS-CoV-2 test', 'Somnolence']",1,PFIZER\BIONTECH,OT 921235,UT,43.0,F,"sore arm; Extreme fatigue; My arms felt like lead for three days; I felt so sleepy/I felt like I could barely keep my eyes open for three days; mild headache; menstrual cramps; diarrhea; I had bizarre dreams like being attacked by zombies for three days; chills; This is a spontaneous report from a contactable pharmacist. A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration at Left arm on 23Dec2020 17:45 at single dose for covid-19 immunization. Patient known allergies included Imitrex, beef, grass, weeds, trees, Cats. Other medical history included Asthma, allergies, migraine, Premenstrual syndrome (PMS), overweight. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but received other medications in two weeks. The COVID-19 vaccine was administered at Hospital. The patient experienced extreme fatigue. Her arms felt like lead for three days, and she felt so sleepy. She felt like she could barely keep her eyes open for three days. She had a mild headache. It triggered menstrual cramps and diarrhea for three days. She had bizarre dreams like being attacked by zombies for three days. She had chills for a few hours. She had a sore arm for a couple of days. Adverse events start date was 23Dec2020 10:00 PM. Treatment included Tylenol. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of chills was recovered on 24Dec2020, of headache, chills, fatigue and sore arm was recovered in Dec2020, of other events was recovered on 26Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Allergic to cats (known allergies: cats); Allergy; Allergy to plants; Asthma; Grass allergy (known allergies: grass); Meat allergy; Migraine; Overweight; Premenstrual syndrome,,,"['Abnormal dreams', 'Chills', 'Diarrhoea', 'Dysmenorrhoea', 'Fatigue', 'Headache', 'Limb discomfort', 'Pain in extremity', 'Somnolence']",1,PFIZER\BIONTECH, 921236,,,F,"tingling a few hours after administration of vaccine and that the symptom has not resolved/from her elbow to her hand was tingling like she hit her funny bone; This is a spontaneous report from a contactable physician (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 28Dec2020, the patient experienced tingling a few hours after administration of vaccine and that the symptom has not resolved. She got her vaccine, and a few hours later, from her elbow to her hand was tingling like she hit her funny bone, and she was wondering if this was a known side effect of the vaccine. Clinical outcome of the event was not recovered. Information on Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,UNK,,,,,,['Paraesthesia'],UNK,PFIZER\BIONTECH, 921237,,,U,"I have headache like migraine headache on the side, off and on like every four hour every three or four hour; Fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced fever on 25Dec2020. The patient also had a headache like migraine headache on the side, off and on like every four hour every three or four hour on an unspecified date. Clinical outcome of fever was recovered on Dec2020, while for migraine headache was unknown. Follow-up attempts are not possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/25/2020,2.0,UNK,,,,,,"['Migraine', 'Pyrexia']",1,PFIZER\BIONTECH, 921238,NJ,65.0,F,"Dizziness since receiving the vaccine; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: ELO140), via an unspecified route of administration on the right arm on 26Dec2020 17:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included reported as none and the patient had no known allergies. The patient's concomitant medications were not reported. It was mentioned that prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. On 27Dec2020 05:00, the patient experienced dizziness since receiving the vaccine. The patient did not receive any treatment for the adverse event. Outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/27/2020,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Dizziness'],1,PFIZER\BIONTECH, 921239,NY,,F,"fair amount of bleeding after the needle was removed/lot of bleeding at the injection site; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history and concomitant medications were not reported. On an unknown date, it was reported that a resident at the hospital had a fair amount of bleeding after the needle was removed. It also mentioned that a lot of bleeding at the injection site. The reporter was unsure if the resident received the Pfizer of Moderna vaccine. Outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PVT,,,,,,['Vaccination site haemorrhage'],UNK,PFIZER\BIONTECH, 921240,TX,53.0,F,"Shortness of breath; heaviness in chest; headache; dizziness; nausea; The patient also received first dose of unspecified other vaccine on the same day of COVID vaccine; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 53-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 29Dec2020 11:30 at single dose for COVID-19 immunization at a hospital. The patient also received first dose of unspecified other vaccine on the same day of COVID vaccine (29Dec2020) at left arm. The patient's medical history included diabetes type 2, arthritis, known allergies to Shrimp and penicillin. The patient's concomitant medications received within 2 weeks of vaccination included unspecified medications. No other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took lisinopril and experienced drug hypersensitivity (Known allergies: Lisinopril). The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 post the vaccination. On 29Dec2020 11:30, the patient experienced shortness of breath, heaviness in chest, headache, dizziness and nausea. Treatment for above events included antihistamine. The outcome of the events shortness of breath, heaviness in chest, headache, dizziness and nausea was recovered in Dec2020. The events were reported as non-serious by the reporter. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Arthritis; Food allergy (known allergies: Shrimp); Penicillin allergy; Type 2 diabetes mellitus (Diabetes type 2),,,"['Chest discomfort', 'Dizziness', 'Dyspnoea', 'Headache', 'Nausea', 'Product use issue']",1,PFIZER\BIONTECH, 921241,PA,50.0,F,"Chills; Muscle ache; Headache; Did not feel well in general; Right arm soreness in the same arm that the COVID vaccine was given; It was hard to lift her arm and woke her up when she was sleeping; It was hard to lift her arm and woke her up when she was sleeping; This is a spontaneous report from a contactable consumer (patient, occupation: Respiratory Therapist). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 22Dec2020 11:00 (reported as Approximately 11am in the morning) at single dose to help stop the spread of COVID. Location of the COVID Vaccine: Right arm. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. There were no prior Vaccinations with 4 weeks. Medical history included she had tested positive for COVID on 02Oct2020. The patient did not have any illness at time of vaccination. Family Medical History Relevant to adverse event also reported as none. There were no concomitant medications. The patient previously had flu vaccine given at the hospital she works at and She had mild arm soreness after the Flu vaccine. The patient experienced Right arm soreness in the same arm that the COVID vaccine was given on 22Dec2020, Chills on 23Dec2020, Muscle ache on 23Dec2020, Headache on 23Dec2020, did not feel well in general on 23Dec2020. Caller reported that she experienced right arm soreness, in the arm she received the vaccine, that was unlike any other vaccine she had ever had. The arm soreness began the same evening as the day she received the COVID vaccine. It was hard to lift her arm and woke her up when she was sleeping in Dec2020. The remainder of the side effects began the following morning after she had received the COVID Vaccine. Other side effects included chills, which lasted until the 24th or 25Dec2020. Muscle aches, which lasted until the 24th or 25th Dec2020. Headaches, which she is still getting off and on, but it is hard to say if the headaches that she is still getting is still from the COVID vaccine. The headaches are coming less often. She has had to take something for the headaches. Caller stated that she did not feel well, in general. Asked caller what other vaccines she had received and had experienced arm soreness but not to the extent she had after the COVID Vaccine and caller stated that she had mild arm soreness after the Flu vaccine. Previous flu vaccines had been given to her at the hospital she works at; therefore, she did not have any lot number information for these flu vaccines. The reported adverse events did not require a visit to Emergency Room and Physician's office. The patient was not hospitalized. The outcome of event Right arm soreness in the same arm that the COVID vaccine was given was recovered on 26Dec2020, the outcome of the event Chills, Muscle ache was recovered in Dec2020, the outcome of the event did not feel well in general was recovered on 25Dec2020. The outcome of the event Headache was recovering. The outcome of the other events was unknown. The causality assessment for events Right arm soreness in the same arm that the COVID vaccine was given, Chills, Muscle ache, Headache, did not feel well in general with suspect COVID vaccine was assessed as related by Primary Source Reporter via Method of assessment Global Introspection. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/01/2020,,PVT,,,Medical History/Concurrent Conditions: COVID-19,,,"['Chills', 'Headache', 'Loss of personal independence in daily activities', 'Malaise', 'Myalgia', 'Sleep disorder due to general medical condition, insomnia type', 'Vaccination site pain']",1,PFIZER\BIONTECH, 921242,AR,,F,"Facial Flushing; throat constriction; feeling faint; This is a spontaneous report from a contactable pharmacist. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, lot number: EJ1685, intramuscular in the left arm, first dose on 28Dec2020 07:45 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced facial flushing, throat constriction, and was feeling faint on 28Dec2020 at 07:45 AM with outcome of recovered on an unspecified date. The patient received treatment for the events with diphenhydramin, methylpred and famotidine. The patient had no covid prior to vaccination nor was she tested post vaccination. The events was reported as non-serious. The events resulted to emergency room/department or urgent care.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Dizziness', 'Flushing', 'Throat tightness']",1,PFIZER\BIONTECH,OT 921243,TX,55.0,F,"itching on my left arm, face and neck; This is a spontaneous report from a contactable Other Health Professional (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: ELO140, via an unspecified route of administration in the arm left, first dose on 28Dec2020 16:15 at a single dose for Covid-19 immunization. Medical history was none, she had no known allergies. There were no concomitant medications. The patient was not pregnant. The patient did not receive any other vaccine within four weeks prior to covid vaccine. She had no covid prior vaccination nor was she tested post vaccination. The patient experienced a little itching on her left arm, face and neck, but other than that, nothing else, all on 28Dec2020 at 04:30 PM with outcome of recovered in Dec2020. No treatment received for the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE,,,['Pruritus'],1,PFIZER\BIONTECH, 921244,MI,34.0,F,"Light headedness/Dizziness/Feeling like I am going to faint; Body weakness like uncontrollable fatigue; Body weakness like uncontrollable fatigue; severe stomach pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiration date: 30Mar2021), via an unspecified route of administration on 27Dec2020 at single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis and fibromyalgia. Concomitant medication included duloxetine hydrochloride (CYMBALTA) as thyroid medication (when probed for thyroid medication, consumer stated, ""CYMBALTA."" (Indication was not clarified further)) and the patient also took her thyroid medications, medication for fibromyalgia. Consumer stated that she just got the COVID vaccine, her first COVID vaccine yesterday (27Dec2020) and she was experiencing some side effects that were more severe than just pain in my arm. When clarified if had pain in arm, consumer stated ""No"", she was experiencing light headedness, dizziness, feeling like I am going to faint, severe stomach pain, body weakness like uncontrollable fatigue in Dec2020. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,12/01/2020,,UNK,CYMBALTA,,Medical History/Concurrent Conditions: Fibromyalgia; Hashimoto's thyroiditis,,,"['Abdominal pain upper', 'Asthenia', 'Dizziness', 'Fatigue']",1,PFIZER\BIONTECH, 921245,MA,58.0,F,"Sore arm; fatigue; lightheaded; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old female patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 28Dec2020 16:15 to 28Dec2020 16:15 at left arm, at single dose for covid-19 immunization. Medical history was none. Allergies to medications, food, or other products was no. Concomitant medication included bupropion hydrochloride (WELLBUTRIN). The patient was not pregnant at the time of vaccination. The patient experienced sore arm, fatigue, lightheaded on 29Dec2020 14:00. No treatment was received for all event. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information about Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,WELLBUTRIN,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dizziness', 'Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH,OT 921246,PA,54.0,F,"chills; chills and fever/ 99.2 degrees Fahrenheit; body aches; tired and lethargic/ feels very fatigue; tired and lethargic; severe headache; This is a spontaneous report from a contactable nurse (patient). A 54-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELO140), via an unspecified route of administration on 28Dec2020 09:15 at single dose on left deltoid for COVID-19 immunization in hospital. Medical history included allergies; COVID-19 and received her positive result on 22Oct2020, the reporter didn't know if that was pertinent, she was out of work for 15 days. Concomitant medication included lisinopril, clarithromycin (CLARITIN) for allergies, mometasone furoate (FLONASE) for allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her flu vaccine was in Oct2020. The patient received the vaccine on 28Dec2020 and was having side effects. No shortness of breath, but she did have some side effects. She felt fine most of the day. In the afternoon around 2PM (28Dec2020 14:00), she developed a severe headache and took 600mg ibuprofen and it didn't touch it. She took another 600mg of ibuprofen in the evening. She felt tired and lethargic on 28Dec2020 20:00 so she went to bed. This morning (29Dec2020) she had body aches and feels very fatigue. She still has a headache. She has chills and fever on 29Dec2020 08:00. Her temperature was 99.2 degrees Fahrenheit about 2 hours before (29Dec2020). The severe Headache was compared to last night it was better, but she still had slight headache. About tired and lethargic, driving to work she wanted to go to sleep. she was at work at her desk and she was not as tired as before. The lot number was on the card she was given. She was not sure if it was ELO140 or EL0140. No emergency room or physician office was required for any adverse event. The outcome of headache, tired and lethargic was recovering, of chills and fever was not recovered, of body aches was unknown. For events severe headache, tired and lethargic, chills and fever, the seriousness was reported as non-serious, the relatedness was related with COVID vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,; CLARITIN; FLONASE,,Medical History/Concurrent Conditions: Allergy; COVID-19,,,"['Body temperature', 'COVID-19', 'Chills', 'Fatigue', 'Headache', 'Lethargy', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 921247,AZ,,F,"body aches/achy; Headache; not feeling great; congestion; Two hours after receiving the vaccine she had a runny nose; 4 hours after she was experiencing some itching in the back of her throat, on her chest, and on her back.; 4 hours after she was experiencing some itching in the back of her throat, on her chest, and on her back.; Allergic reaction; heated flushing feeling in her cheeks; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for herself. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E49899), via an unspecified route of administration on 27Dec2020 at single dose for covid-19 immunization. It was the first dose. Medical history included allergic to shellfish. There were no concomitant medications. Two hours after receiving the vaccine on 27Dec2020 she had a runny nose. Then, 4 hours after she was experiencing some itching in the back of her throat, on her chest, and on her back. She didn't have a rash. She did feel like what she was having was an allergic reaction. She had a heated flushing feeling in her cheeks. It was very similar to the reaction she has when she eats shellfish. The allergic side effects have subsided. When she was having the reaction she took one Claritin, and it ended up going away. Yesterday the 28Dec2020. She was also achy. She had a headache, and body aches. She wasn't feeling great, but they have gone away. She also had congestion. Those all started the 28Dec2020 in the morning. The outcome of the events was recovered on an unknown date in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Shellfish allergy,,,"['Flushing', 'Headache', 'Hypersensitivity', 'Malaise', 'Nasal congestion', 'Pain', 'Pruritus', 'Rhinorrhoea', 'Throat irritation']",1,PFIZER\BIONTECH, 921248,MO,41.0,F,"Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated itching that began localized to the injection site then spread all over the body. Felt like a burning sensation as well and an itch you can't scratch on 29Dec2020. Patient received Benadryl as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered. The events were reported as non-serious. No follow-up attempts are possible; Information about batch/lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,,,,,,"['Burning sensation', 'Pruritus', 'Vaccination site pruritus']",1,PFIZER\BIONTECH, 921249,,51.0,M,"Contracted Covid after receiving the first vaccine; Contracted Covid after receiving the first vaccine; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunisation. Medical history included asthma, dry cough due to inhalation from fires over the years. The patient's concomitant medications were not reported. Contracted Covid after receiving the first vaccine was reported. The patient received the first dose of the Covid vaccine, then contracted Covid. He now had the option to receive antibodies through plasma. Since he had the vaccine, was that still an option? Or was that a no-no? He received the vaccine at work on 21Dec2020. He got sick on 22Dec2020 and he was at home. He didn't feel like eating, and can't lay down because it made it worse to cough. He didn't know what vitamins they were giving him. The patient probably should be in a hospital, but was not. The outcome of events was not recovered. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/22/2020,1.0,WRK,,,Medical History/Concurrent Conditions: Asthma; Dry cough (due to inhalation from fires over the years.),,,"['COVID-19', 'Cough', 'Decreased appetite', 'Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 921250,,,U,"Fever was up to 102.4; Chills; Body ache; This is a spontaneous report from a contactable consumer (patient herself). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 27Dec2020, the patient experienced fever was up to 102.4, chills, and body ache. Therapeutic measures were taken as a result of the events that included ibuprofen (Motrin). Clinical outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/27/2020,7.0,UNK,,,,,,"['Body temperature', 'Chills', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 921251,,,F,"Diarrhea; she had body aches; Tingling in her Jaw and in her mouth; Headache; Nausea; She is having extreme difficulties; not feeling well; Not sleeping well during the night; tingling in her Jaw; This is a spontaneous report from a contactable Consumer(mother). A female patient received (BNT162B2), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The reporter was giving her daughter's name she was the respiratory therapist at the hospital and she received the Pfizer Covid Vaccine last Monday in Dec2020 and she was having extreme difficulties today. She had diarrhea, she had body aches, she had tingling in her mouth, headache, her nausea and all of the sudden it started with yesterday in Dec2020 and perhaps the day before it started with the tingling in her Jaw and in her mouth and she woke up today and not feeling well and she took a nap after not sleeping well during the night and when she woke up from the nap she had extreme body aches, diarrhea, nausea, headache. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Diarrhoea', 'Headache', 'Malaise', 'Nausea', 'Pain', 'Paraesthesia', 'Paraesthesia oral', 'Poor quality sleep']",UNK,PFIZER\BIONTECH, 921252,HI,60.0,F,"Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm cough; Bronchospasm cough; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Spasm; she has a lot of allergies; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 to 23Dec2020 at 0.3 mL single on left deltoid to prevent getting the COVID vaccine, for protection. Medical history included ongoing asthma diagnosed in her mid twenties, in the 80s, she had asthma when she was a child, then it stopped and resurfaced in her mid twenties, ongoing eczema diagnosed years already, a long time ago and unspecified allergies with medications. There were no concomitant medications. She received the vaccine on 23Dec2020. She has a lot of allergies in Dec2020, and had some side effects, and she got through it ok. Her side effects were some swelling of arm, a rash developed, like 5cm x 4cm at site of injection, chills and shivers, and a bronchospasm cough on 24Dec2020. Arm swelling event started 24 hours later, no more, it was stable for 24 hours, and the 3rd day, went down, was a little raised, the next day was flat but still red. She had recovered completely. The 4th day was a good day. The patient stated she had some allergy shots she had to go through before, this was no different. Rash was no more, it was gone by 27Dec2020. She was still able to go to work. Chills and shivers started 24 hours later, and took for 48 hours intermittently, she had since recovered completely. The patient stated this was all nothing different than getting like the flu shot. Bronchospasm cough event only took another 48 hours, the difference was, even when she calls it bronchospasm, it was close to when she had an asthma attack, but no chest tightness, shortness of breath, she just would cough, spasm in Dec2020 and stop. She had recovered completely. The patient stated she had no symptoms at all before the vaccine, she was healthy, she made sure nothing was going on, that she was not tired, had no cold, she took no medications for this, as she wanted to know how her body reacted and if it can handle it. They says it was ok to take paracetamol (TYLENOL), but she did not, but the second dose she would, now that she knows and she was comfortable through it. She did have some mild eczema flare ups, itchiness and sores that came up in Dec2020, but nothing to run to the hospital to the doctor for. Clarifies this occured after she received the vaccine. The outcome of the event allergies, mild eczema flare ups, itchiness and sores were unknown. The outcome of rash at site of injection was recovered on 27Dec2020. The outcome of other events was recovered in Dec2020. The causality between Pfizer COVID vaccine with some swelling of arm, rash developed 5cm x 4cm at injection site, chills and shivers, bronchospasm cough was related (Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection). Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/01/2020,,UNK,,Asthma; Eczema,Medical History/Concurrent Conditions: Drug allergy,,,"['Bronchospasm', 'Chills', 'Cough', 'Eczema', 'Hypersensitivity', 'Muscle spasms', 'Pain', 'Peripheral swelling', 'Pruritus', 'Vaccination site rash']",1,PFIZER\BIONTECH, 921253,MS,49.0,F,"throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it feels like muscle spasms; extremely tired; soreness in her arm; Chills; Nausea; felt weak/having some weakness; massive headache/mild headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 28Dec2020 11:00 on left arm at a single dose for COVID-19 immunization. The patient was positive for Covid back in Jun2020, it was a bad case that she was hospitalized for 6 days, that she did not have to go on respirator. She stated these days she still struggled with chest pains and still struggled with her taste, she went to the emergency room in Sep2020 with some issues from that. The patient concomitant medications were none. The patient stated she was retired who works security at a hospital that she got her first dose of the Pfizer Covid vaccine yesterday on 28Dec2020. She was calling to report some side effects from the vaccine. She was skeptical about shot but she went ahead and got the vaccine, she took it and waited the 15 minutes and everything was fine except some soreness in her arm, about an hour after the shot, she felt extremely tired, could not even read, by last night she was getting chills, nauseated and weak, all she wanted to do was sleep, she had a massive headache. She kept thinking she was going to have to go to the ER. She woke up this morning and her throat was sore, felt like it may be swelling, felt sick. She took two advil and her headache was better. She was taking tumeric and ginger root and honey with lemon for her throat. She knew she was not sick that it is just the vaccine and she would power through it but wanted to call. She was starting to feel better but still having some weakness, still tired, had pain in the arm of the injection site, a mild headache. She stated these side effects are still ongoing but are improved. She was also having some neck pain started this morning sometime, but does not know exact time, it feels like muscle spasms. Caller wanted to know if because she had Covid before her side effects are so bad. The patient did not do any relevant tests. The outcome of the events soreness in her arm, extremely tired, Headache was recovering, the outcome of the events Chills, Nausea was recovered in Dec2020 and the other events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,,"Medical History/Concurrent Conditions: Chest pain (she went to the emergency room in Sep2020 with some issues from that); COVID-19 (hospitalized for 6 days, that she did not have to go on respirator.); Taste disorder (she went to the emergency room in Sep2020 with some issues from that)",,,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Muscle spasms', 'Nausea', 'Neck pain', 'Oropharyngeal pain', 'Pharyngeal swelling', 'SARS-CoV-2 test', 'Vaccination site pain']",1,PFIZER\BIONTECH, 921255,PA,,F,"numbness in pinky of left arm; soreness at spot of injection; fatigue; This is a spontaneous report from a contactable consumer. An adult female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not available), via an unspecified route of administration on 27Dec2020 at single dose on her left arm for Covid-19 immunization. The patient medical history was not reported. The patient had received unknown other medications within 2 weeks of vaccination. The patient experienced numbness in pinky of left arm and soreness at spot of injection and fatigue on 27Dec2020. The outcome of the events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,PVT,,,,,,"['Fatigue', 'Hypoaesthesia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 921256,IL,32.0,F,"is nursing twins; is nursing twins; slight headache; arm soreness; This is a spontaneous report from a contactable other health professional (patient). This other health professional reported information for both mother and babies. This is the maternal report. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 16Dec2020 11:00 AM at left arm, at single dose for protect as a healthcare provider. Medical history was none. There were no concomitant medications. The patient experienced like arm soreness and slight headache on 16Dec2020, that was pretty much it. Arm soreness started that afternoon on 16Dec2020, she received the vaccine in the morning, at 11am, and maybe like shortly after she noticed, it was there for 1-2 days and went away, and she had since recovered completely. Slight headache started that afternoon on 16Dec2020, and that resolved by the evening, she took Tylenol and it went away. And she was nursing twins, they are about 14 months now. She was aware of the risks of getting it, and the only reason she reported it, is it may be beneficial from a research standpoint, she doubts many lactating mothers, especially twins, are involved. She is personally not concerned, she is probably expecting similar for her second dose, and there is not much research. Her next is dose 06Jan2021. The outcome of the events slight headache was recovered on 16Dec2020, the outcome of the event arm soreness was recovered in Dec2020.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518603 Same reporter/drug, different patient/event. baby case;US-PFIZER INC-2020518630 Same reporter/drug, different patient/event. bady case",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Headache', 'Off label use', 'Pain in extremity', 'Product use issue']",1,PFIZER\BIONTECH, 921257,TX,,F,"Feeling sick; Fever of 102 degrees; Coughing; Aching; This is a spontaneous report from a Pfizer-sponsored program entitled Pfizer First Connect. A contactable consumer reported for his sister (health professional) that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date in Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient took the COVID vaccine but she was feeling sick, had a fever of 102 degrees, she was coughing and aching from couple of days after having couple of days in Dec2020. The events outcome was unknown. The reporter mentioned if patient goes to the hospital or not, asked if they should go to the hospital and. The patient was wondering if that was normal. The information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,PVT,,,,,,"['Body temperature', 'Cough', 'Malaise', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 921258,PA,,F,"tiredness; muscle ache at injection site with penny sized welt at injection site; muscle ache at injection site with penny sized welt at injection site; This is a spontaneous report from a contactable nurse (patient) via Pfizer sales representative. A female patient of unspecified age (reported as Age: 32; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not available), via an unspecified route of administration on 28Dec2020 at 12:30 PM at single dose for COVID-19 immunization. The patient medical history included had COVID 34 days before in 2020. The patient's concomitant medications were not reported. Currently patient was experiencing tiredness, muscle ache at injection site with penny sized welt at injection site in Dec2020. Event took place after use of product. The outcome of the events was unknown. Information on the Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Fatigue', 'Vaccination site pain', 'Vaccination site urticaria']",UNK,PFIZER\BIONTECH, 921259,,,U,"pain in the administration site; tired; feeling dehydrated; had a low degree fever; nostrils were stuffed or clogged; pain in the arm; went to sleep 3 hours earlier than usually did, waking up five hour later; feeling like that was about to had flu; This is a spontaneous report from a contactable consumer. This consumer reported same events for two patients (Herself and Her friend).This is the Friend report. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknown date at single dose for covid-19 immunization. It was the second dose. The patient's medical history and concomitant medications were not reported. The Consumer reported that the same symptoms were experienced by a friend of her after the administration of the second dose of the Pfizer's COVID-19 vaccine. The same symptoms included felt only pain in the administration site, at night felt really tired, went to sleep 3 hours earlier than usually did, waking up five hour later with pain in the arm and feeling dehydrated, also feeling like that was about to had flu, had a lowdegree fever, and nostrils were stuffed or clogged. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518390 Same Reporter and Drug and event, different Patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Dehydration', 'Fatigue', 'Hypersomnia', 'Influenza like illness', 'Nasal congestion', 'Pain in extremity', 'Pyrexia', 'Vaccination site pain']",2,PFIZER\BIONTECH, 921260,,,M,"pain in the administration site; a strong headache; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient took his first dose of BNT162B2 for covid-19 immunization on an unspecified date. The patient was experiencing pain in the administration site, and a strong headache that has been fading away. The action taken in response to the events for BNT162B2 was not applicable. The outcome of event ""strong headache"" was recovering, the another event ""pain in the administration site"" was unknown. Information about Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/01/2020,,UNK,,,,,,"['Headache', 'Vaccination site pain']",2,PFIZER\BIONTECH, 921261,,,F,"This morning she felt bad; She has an autoimmune disease/ received BNT162B2; She has an autoimmune disease/ received BNT162B2; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included autoimmune disease and has been under stress from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced felt bad this morning on an unspecified date with outcome of unknown. Caller was a therapist, behavioral specialist and works and they are all over. It's a hospital and she was in the psychiatric phase of it as a therapist. They are offering the free COVID-19 vaccine since she was working 1 on 1 with clients and some of them are not the most reputable. She has an autoimmune disease and known she should get it, but has had so many doubts and has been under stress. Took care of a brother who was blind who recently had major shoulder surgery and her 91 years old mother who lived with her. Has been stressed and noticed her autoimmune disease was flaring up. Wanted to know was it safe for her to get the vaccine. Knows she should get the vaccine because 2 of her clients had tested positive for COVID and their parents, but when she tested she was negative and her family was also negative. No further details provided. Is so afraid to get the vaccine that she canceled her appointment at the hospital. Was scheduled today to get it. They are offering it to her free since she works there. This morning she felt bad and she had been going through the stress the last month. Mentions she didn't even get the flu this year. No further details provided and does not clarify if she didn't get the flu virus or flu shot. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Autoimmune disorder; Stress,,,"['Feeling abnormal', 'Off label use', 'Product use issue']",UNK,PFIZER\BIONTECH, 921262,IL,43.0,M,"Body chills; fever; headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), via an unspecified route of administration (left arm) on 29Dec2020 08:15 at single dose for Covid-19 immunization. The patient's medical history included hypertension (HTN) and high cholesterol. Concomitant medications included losartan, atorvastatin, and amlodipine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced body chills, fever, and headache on 29Dec2020 22:00 with outcome of recovering. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,WRK,; ;,,"Medical History/Concurrent Conditions: High cholesterol (other medical history: HTN, high cholesterol); Hypertension (other medical history: HTN, high cholesterol)",,,"['Chills', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH, 921263,NY,35.0,F,"mild headache; This is a spontaneous report from a contactable nurse (patient). This 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot GJ1685), via an unspecified route of administration, on 22Dec2020 (reported also as 23Dec2020, to be clarified) at 3:00 PM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at Nursing Home/Senior Living Facility, age at vaccination was 35-years-old. No other vaccine was received in four weeks. Medical history and concomitant medications were unknown. On 22Dec2020 at 07:00 PM, the patient got mild headache. The event was reported as non-serious. The patient was tested for Covid post vaccination through a nasal swab in Dec2020 and was negative. Outcome was recovered on Dec2020. No treatment was received for the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Headache', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 921264,TN,56.0,F,"soreness in arm when using arm or to touch; This is a spontaneous report from a contactable nurse. A 56-year-old female nurse received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 28Dec2020 at 12:30 PM at single dose for COVID-19 immunization on right arm.Relevant medical history included ongoing osteoarthritis and high cholesterol. Concomitant medications included atorvastatin calcium (LIPITOR ORIFARM), escitalopram oxalate (LEXAPRO) and pantoprazole. On 28Dec2020 at 07:00 PM patient started experiencing soreness in arm when using arm or to touch. At the time of the reporting the patient was recovering from the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,WRK,LIPITOR ORIFARM; LEXAPRO;,"High cholesterol; Osteoarthritis (osteoarthritis, high cholesterol)",Medical History/Concurrent Conditions: Latex allergy (known allergies: latex),,,['Pain in extremity'],1,PFIZER\BIONTECH, 921265,MN,45.0,F,"Face started to tingle then went numb roughly 45-55 minutes after receiving.; Face started to tingle then went numb roughly 45-55 minutes after receiving.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received bnt162b2 (lot number: EL0140, Pfizer- BioNTech), intramuscularly at arm left, first dose on 23Dec2020 07:45, at single dose, for COVID-19 immunization. Medical history included environmental allergies, iron deficiency anemia, endometriosis, allergies to penicillin, and allergies to preservatives in flu vaccine from an unknown date. The patient is not Pregnant at the time of vaccination. Concomitant medication included ibuprofen, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12), magnesium, all from an unspecified date, for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Age at vaccination is 45 Years old. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced face started to tingle then went numb roughly 45-55 minutes after receiving (reported as from 23Dec2020, 08:30 AM). Not sure if that is an actual reaction but it occurred. The event was reported as non-serious. Therapeutic measures were taken as a result of face started to tingle then went numb roughly 45-55 minutes after receiving, treatment included BENADRYL orally taken. The outcome of the event was recovered in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,; VITAMIN D [COLECALCIFEROL]; VITAMIN B12 [CYANOCOBALAMIN];,,Medical History/Concurrent Conditions: Drug allergy; Endometriosis; Environmental allergy; Iron deficiency anemia; Penicillin allergy,,,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,OT 921266,,,F,"She experienced soreness at the site; fatigue; numbness in the left pinky finger; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 27Dec2020 at SINGLE DOSE for COVID-19 IMMUNIZATION. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer Covid Vaccine at on 27Dec. She experienced soreness at the site and fatigue on 28Dec-29Dec and numbness in the left pinky finger (same arm as vaccination). She also started another med the same day, so she is unsure if the fatigue is from vaccination or the other drug. I do not know the name of that drug. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,12/01/2020,,UNK,,,,,,"['Fatigue', 'Hypoaesthesia', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 921267,,,F,"large induration; fever; Chills; vomiting; This is a spontaneous report from a contactable consumer. A 3-decade-old (precise age unknown, early-to-mid 20s) female patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that post dose 1 of ""COMIRNATY COVID-19 mRNA-based vaccine"" on 28Dec2020, the patient experienced large induration, fever, chills and vomiting. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,,,UNK,,,,,,"['Chills', 'Induration', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH, 921268,TN,36.0,F,"I just developed a very sore throat; This is a spontaneous report from a contactable nurse (patient herself). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 28Dec2020 at a single dose for COVID-19 immunisation. Medical history was none. Concomitant medications included multivitamins (unspecified). The patient just developed a very sore throat on 29Dec2020. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Oropharyngeal pain'],UNK,PFIZER\BIONTECH,OT 921269,MS,58.0,F,"Elevated heart rate, headache; Elevated heart rate, headache; This is a spontaneous report from a contactable other Healthcare Professional (HCP, patient). This 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730), intramuscular, on 29Dec2020 at 12:30 PM at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was vaccinated at hospital, age at vaccination was 58-years-old. No other vaccine was received in four weeks. Medical history was unknown. Concomitant medications included rosuvastatin calcium (CRESTOR) and lisinopril. On 29Dec2020 at 04:00 PM, the patient experienced elevated heart rate, headache. The event was reported as non-serious. Outcome was recovered on Dec2020. No treatment was received for the event. No follow up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,CRESTOR;,,,,,"['Headache', 'Heart rate', 'Heart rate increased']",1,PFIZER\BIONTECH,OT 921270,NY,30.0,F,"headache; constipation; This is a spontaneous report from a contactable other HCP. A 30-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular in left arm on 23Dec2020 at a single dose for covid-19 vaccination. The vaccine was administered in the workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient was not pregnant. On 24Dec2020, the patient experienced constipation and headache since vaccine (7 days). The outcome of the events was unknown. There was no treatment for the events. ON 24Dec2020, the patient had COVID test type post vaccination=Nasal Swab with a negative result. The events were assessed as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/24/2020,1.0,WRK,,,,,,"['Constipation', 'Headache', 'Investigation']",1,PFIZER\BIONTECH,OT 921271,PA,50.0,F,"Extreme fatigue, body aches, and headaches that began around day 4 post vaccine.; Extreme fatigue, body aches, and headaches that began around day 4 post vaccine.; Extreme fatigue, body aches, and headaches that began around day 4 post vaccine.; This is a spontaneous report from a contactable Other HCP reporting for herself. A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730), Intramuscular on 22Dec2020 17:45 at single dose for covid-19 immunisation. Vaccine administered in left arm. Medical history included Anemia and Hypothyroidism. Patient is not pregnant. Concomitant medication was not reported. Patient had allergies to Levaquin. The patient experienced extreme fatigue, body aches, and headaches that began around day 4 post vaccine on 26Dec2020. Patient has not been tested for coronavirus disease (COVID-19). Patient was not diagnosed with COVID-19. Outcome of events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/26/2020,4.0,PVT,,,Medical History/Concurrent Conditions: Anemia; Hypothyroidism,,,"['Fatigue', 'Headache', 'Pain']",1,PFIZER\BIONTECH,OT 921272,VA,52.0,M,"Stye developed over right eyelid; This is a spontaneous report from a contactable other hcp (patient). A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) intramuscularly at left arm on 17Dec2020 14:00 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced stye developed over right eyelid on 18Dec2020 06:00. No treatment received. The event is non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on an unspecified date in Dec2020. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,,,,,,['Hordeolum'],1,PFIZER\BIONTECH,OT 921273,IN,,F,"Lot of swelling at my injection site and my glands under my arms; Lot of swelling at my injection site and my glands under my arms; This is a spontaneous report from a contactable consumer (patient). The 49-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EL1284), unknown on an unknown date in Dec2020 at single dose for COVID-19 immunisation. Medical history included Allergy and asthma. Patient also took take allergy medicine and have to use an asthma inhaler. It was reported "" I got the Pfizer COVID Vaccine and I had a lot of swelling at my injection site and my glands under my arms"". When talking about treatment, Consumer stated, ""I did ice, I did heat, I did allergy cream (Unspecified Medication), I didn't go to the doctor where they follow up with you and check on you, the swelling got up to like 6 inches."" The outcome of the events was unknown. No follow-up attempts are needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Allergy (Verbatim: Allergy); Asthma (Verbatim: Asthma),,,"['Lymphadenopathy', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 921274,VA,37.0,F,"Felt tongue tingle; had a weird sensation on tongue. At first I thought I was tasting something but I wasn't; felt a bit of nausea which is a normal side effect; This is a spontaneous report from a contactable other hcp (patient). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 29Dec2020 09:30 at single dose for COVID-19 immunization. No medical history. No known allergies. The patient's concomitant medications were not reported. The patient felt tongue tingle and had a weird sensation on tongue. At first she thought she was tasting something but she wasn't. This lasted for about 30 mins. She also felt a bit of nausea which was a normal side effect. She was not sure what the tongue feeling was. Events onset date was 29Dec2020 10:00. No treatment received. This report is non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Nausea', 'Paraesthesia oral', 'Tongue disorder']",1,PFIZER\BIONTECH, 921275,RI,,M,"developed a circular rash at injection site/localized; This is a spontaneous report from a contactable physician. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The reporting physician was inquiring about information related to development of a rash at the injection site, and to report an adverse event. The patient got vaccine on 18Dec2020. 10 days later, on 28Dec2020, the patient developed a circular rash at injection site/localized (circular ""like lyme disease""). Localized rash was 3cm in diameter. Per reporter, the patient was ""feeling otherwise okay"". The patient had been tested negative for lyme disease. Outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/28/2020,10.0,UNK,,,,,,"['Investigation', 'Vaccination site rash']",UNK,PFIZER\BIONTECH, 921276,MO,,F,"tenderness or soreness; tenderness or soreness; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program. A 73-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration in Dec2020 at single dose for covid-19 immunization. Medical history included lupus. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL) for lupus. The patient experienced tenderness or soreness in Dec2020. She mentioned she read the fact sheet and felt nothing, there was only tenderness or soreness but it didn't bother. The outcome was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,PLAQUENIL [HYDROXYCHLOROQUINE SULFATE],,Medical History/Concurrent Conditions: Lupus syndrome,,,"['Pain', 'Tenderness']",UNK,PFIZER\BIONTECH, 921277,,,U,"Absolutely no side effects other than a sore arm; This is a spontaneous report from a Pfizer-sponsored program received from a non-contactable consumer. A patient of unspecified age and gender started to receive bnt162b2 (BNT162B2; reported as Pfizer Covid-19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at single dose for Covid-19 vaccination. The patient's medical history and concomitant medications were not reported. It was reported that it's been a week since the patient received the Pfizer Covid-19 vaccine. There were absolutely no side effects other than a sore arm for 2ish days (unspecified date). The patient will be the first to admit that the patient was skeptical and wasn't eager to jump in line. After a few conversations with trusted colleagues and researching reliable websites, the patient decided that this was the least the patient could do. The patient was eager to see friends and family. The patient also mentioned that the patient was eager for the hospital to not be busting at the seams. Eager to not work 5 nights a week to do his/her part and eager to not see his/her friends/colleagues exhausted. The patient was also selfishly anxious to travel again. This vaccine gives us a light at the end of a very long dark tunnel. It gives us the first glimmer of hope we've had all year. The outcome of the event was unknown. No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 921278,WV,,U,"patient receive the first dose of the vaccine and has now tested positive for Covid; patient receive the first dose of the vaccine and has now tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported a patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that they had a patient receive the first dose of the vaccine and has now tested positive for Covid. He stated the patient is a week out from receiving the second dose and asks what information Pfizer can provide on receiving the second dose for someone with Covid infection. Outcome of the event was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 921280,TX,38.0,F,"Nervous; I had two new spot on my knee; I had another one on my shoulder and on my lower back/I am getting one may be on my ear like I said they pop up and they itch a little; Red patchy hives and itchy waves of red rashes all over the body; raised red rash on my left hip; Red patchy hives and itchy waves of red rashes all over the body; raised red rash on my left hip; Red patchy hives and itchy waves of red rashes all over the body; raised red rash on my left hip; This is a spontaneous report from a Pfizer-sponsored program. A contactable 38-year-old female Nurse (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, Expiry Date: 31Mar2021) at single dose since 22Dec2020. Relevant history and concomitant drug was none. The patient excepted Covid 19 vaccine could decrease the chance of contacting Covid 19 virus, while she stated she was getting a red patchy hives and itchy waves of red rashes all over the body just after received the vaccine. The patient (nurse) stated, ""I would if I can explain a little more, the day after I received the Covid vaccine I had noticed a big like what I would explain it like a red hives, like a raised red rash on my left hip it last like a day its subsided and next morning I woke up and I had a different flares that was the same on my other side of my body again went away. After a day when I woke up and I had two new spot on my knee that was the other thing, those went away on that day. This morning I woke up and I had another one on my shoulder and on my lower back. I am also thinking I am getting one may be on my ear like I said they pop up and they itch a little and they go away. I never ever experienced anything like it and I see the only thing that I have changed in my life or regimen or added to my body so I just wanted to make sure it was reported. I am nervous and curious if it is a potential side effect added if I should be careful before getting second one all those things."" No treatment was received for the events. Outcome of events was unknown. When probed for the Causality, the nurse stated, ""I have no idea, if it is something going on with me that is completely unrelated its just occurred right after I got the vaccine so I have no idea if this is a separate issue or not. I going to see dermatologist and physician but until then I just thought to report it to you all to see if anybody is experiencing this and to know if it is safe to go for second dose.""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/23/2020,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Nervousness', 'Pruritus', 'Rash erythematous', 'Rash macular', 'Rash papular']",UNK,PFIZER\BIONTECH, 921281,IN,36.0,F,"Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; This is a spontaneous report from a contactable other HCP. This 36-year-old female other HCP reported for herself that that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular at right arm at single dose for COVID-19 immunisation on 22Dec202008:00 AM. Relevant history included Endometriosis and allergies with Keflex, Levsin. Concomitant drug included bupropion SR which received within 2 weeks of vaccination. The patient experienced shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of neck 4 days after vaccine. Tightness on chest was gradually improving but comes and goes daily for the past week. The events was considered as non-serious. No treatment was received. The outcome of events was reported as recovered with lasting effects. The patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient been tested for COVID-19 with negative result per Nasal Swab on 23Dec2020. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Endometriosis,,,"['Chest discomfort', 'Dyspnoea', 'Heart rate', 'Heart rate increased', 'Limb discomfort', 'Lymphadenopathy', 'SARS-CoV-2 test', 'Vaccination site pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH,OT 921282,TN,49.0,F,"swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle and body aches; shortness of breath; headache/migraine; headache/migraine; runny nose; sneezing; soreness in upper and lower left arm; swelling in left arm and in both hands; This is a spontaneous report from a contactable Other HCP (patient). This 49-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EJ1685) at single dose on 28Dec2020 at 02:00 PM on left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia; skin lupus; sacroiliitis; chronic migraines; allergies to Latex, TB shot skin test, several foods, environmental things (trees, grass, pollen, cockroaches, etc.). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. Since the vaccination, the patient had not been tested for COVID-19. On 29Dec2020 at 06:15 AM, the patient experienced swelling and redness in the face, muscle and body aches, shortness of breath, fatigue, headache/migraine, runny nose, sneezing, swelling in left arm and in both hands. There was not treatment received for all the adverse events. All events considered non-serious as all not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of events was not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,WRK,,,Medical History/Concurrent Conditions: Chronic migraine; COVID-19; Environmental allergy; Fibromyalgia; Food allergy; Latex allergy; Lupus syndrome; Sacroiliitis; Specific allergy (drug),,,"['Dyspnoea', 'Erythema', 'Headache', 'Migraine', 'Myalgia', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Rhinorrhoea', 'Sneezing', 'Swelling face']",1,PFIZER\BIONTECH, 921283,TX,49.0,F,"I broke out, I was sweating; Terrible headache; Chills; My body hurt; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on 29Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included seasonal allergy. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for seasonal allergy. On 29Dec2020 (within a few minutes), she broke out and was sweating. She had sweat at her face and sweated in her clothes. The patient also have a terrible headache, her body hurt and have chills. The patient did not receive any treatment for the events and was going to ask if she can take diphenhydramine (BENADRYL) as she do not know what to do. She doesn't know if she can take medicine because it was terrible. Outcome of the events were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,ZYRTEC,,Medical History/Concurrent Conditions: Seasonal allergy,,,"['Chills', 'Headache', 'Hyperhidrosis', 'Pain']",UNK,PFIZER\BIONTECH, 921284,,,U,"lost my sense of smell and tested positive for Covid; lost my sense of smell and tested positive for Covid; This is a spontaneous report from a non-contactable consumer (patient) received via a Pfizer-sponsored program. A patient of unspecified age and gender received BNT162B2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The content of a post was noted that on Dec2020, ""Got mine! And in a stroke of weird ironic awfulness, lost my sense of smell and tested positive for Covid later that day....If only a month sooner! Thank you for creating this vaccine. I know it had nothing to do with my diagnosis!"". The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. Sender's Comments: The events drug ineffective and COVID 19 are likely intercurrent and are unrelated to suspect drug BNT162B2 based on the short temporal relation between vaccination and onset of events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/01/2020,,UNK,,,,,,"['Anosmia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 921285,RI,52.0,F,"Mild to severe headache behind her eye and sinus area; Mild to severe headache behind her eye and sinus area; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 21Dec2020 at 10:15 AM, at single dose, for COVID-19 immunisation. Medical history included peanut allergy, penicillin allergy and nut allergy (unknown if ongoing). Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient experienced mild to severe headache in Dec2020, days after the COVID-19 injection. Main complaint was headache behind her eye and sinus area. The event required physician office visit on 29Dec2020. It was unknown if the event required any treatment. The events was considered as non serious. The patient was unsure if this was related to the vaccine but informed the reporter. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/01/2020,,PVT,,,Medical History/Concurrent Conditions: Allergy to nuts; Peanut allergy; Penicillin allergy,,,"['Headache', 'Sinus headache']",UNK,PFIZER\BIONTECH, 921286,SC,,F,"Body aches, chills and body temperature max of 101.2 F; Body aches, chills and body temperature max of 101.2 F; Body aches, chills and body temperature max of 101.2 F; she should not have taken the vaccine with us; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 21Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced body aches, chills and body temperature max of 101.2 F on 22Dec2020 with outcome of recovered on 23Dec2020. On 22Dec2020 she spent the day in bed. The reporting nurse stated that the patient was part of a trial study. She was vaccinated in a blind study on 28Nov2020. The patient told the reporter on 23Dec2020 that she called the intake person the week before and they told her to take the vaccine here with Pfizer. She called them back after she experienced the events and spoke with a different person who stated she should not have taken the vaccine with Pfizer. They will not un-blind her at this point either. The reporter felt certain based on her response last week that she must have received the vaccine on 28Nov2020 and not the placebo. The patient wished to drop from the study and take the 2nd Pfizer vaccine in 3 weeks. Her PCP agreed that she should do so. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,UNK,,,,,,"['Body temperature', 'Chills', 'Pain', 'Pyrexia', 'Wrong product administered']",1,PFIZER\BIONTECH, 921287,FL,,F,"she is positive that she is positive"" and is having symptoms, although not yet been tested; she is positive that she is positive"" and is having symptoms, although not yet been tested; This is a spontaneous report from a contactable pharmacist (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reportedly asking if she should keep her appointment for the second dose of the vaccine as scheduled if she thinks she was positive for COVID and having symptoms. The patient had vaccine on Tuesday (Dec2020), and husband tested positive yesterday, ""she was positive that she was positive"" and was having symptoms, although not yet been tested. The 2nd dose was in 2 weeks. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently provided, the company considers that a causal relationship between the suspected COVID-19 and vaccination with BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,['Exposure to SARS-CoV-2'],1,PFIZER\BIONTECH, 921288,TN,49.0,F,"headache; Muscle aches; Chills; 102.5 fever; This is a spontaneous report from a contactable Nurse. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EJ1685), via an unspecified route of administration on 28Dec2020 09:00 at Arm Left at single dose for COVID-19 immunisation. Medical history included Low thyroid, Covid (diagnosed with COVID-19: Yes). Concomitant medication included levothyroxine sodium (SYNTHROID). The patient experienced muscle aches, chills, headache, 102.5 fever on 28Dec2020 18:00. All events were non serious. No treatment was received. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient underwent lab tests and procedures which included body temperature: 102.5 on 28Dec2020. The outcome of the events was resolved in Dec2020. No follow up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,SYNTHROID,,Medical History/Concurrent Conditions: COVID-19 (diagnosed with COVID-19:Yes); Thyroid hormones decreased,,,"['Body temperature', 'Chills', 'Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH, 921289,NJ,48.0,F,"deltoid muscle pain in left arm where she got the shot; Left arm feeling heavy in within 2 hours of vaccination, hard to lift up; she was feeling very tired and in day-2 she felt fatigue; This is a spontaneous report from a contactable consumer reporting for a patient. A 48-year-old female patient received first dose of BNT162B2, (Pfizer-BioNTech Covid-19 Vaccine, lot number EH9899) , via an unspecified route of administration on 28Dec2020 10:00 at single dose on left arm for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medications were none. The patient experienced deltoid muscle pain in left arm where she got the shot (28Dec2020 12:00). Left arm feeling heavy in within 2 hours of vaccination, hard to lift up (28Dec2020 12:00). In the afternoon she was feeling very tired and in day-2 she felt fatigue, took Tylenol multiple times a day. On day-3 she felt perfectly fine and no pain was left. Functioning properly. No known allergies. The patient did not receive other vaccine in four weeks. No covid prior vaccination; no covid tested post vaccination. The patient was not pregnant at the time of vaccination. Therapeutic measures were taken as a result of deltoid muscle pain in left arm where she got the shot. The outcome of the events was resolved on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Fatigue', 'Limb discomfort', 'Vaccination site pain']",1,PFIZER\BIONTECH, 921290,NC,33.0,F,"really tired; heart pounding; couldn't sleep; Headache; sore arm; She couldn't sleep because she was anxious.; almost felt like her blood pressure was up.; Her heart rate is usually 60-65 bpm, but last night it was up to 75-80 bpm; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EIC9231), via an unspecified route of administration on 29Dec2020 11:30 at single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient was calling to report that she got the COVID vaccine yesterday, and she wanted to put input in on the effects she experienced last night. She is a pharmacy transition specialist. She doesn't have a prescribing doctor. A few hours after, she was really tired. She could have fallen asleep at her desk. Then, last night, her heart was like pounding but not beating fast if that makes since. Her heart rate wasn't up that much, but it felt like it was going to come out of her chest. She couldn't sleep because of it. She had a headache. She received the vaccine at 11:30. She is not as tired today. Yesterday, she could have just laid head back and went to sleep. The rest of the side effects started right after dinner. She couldn't sleep because she was anxious. Her heart rate is usually 60-65 bpm, but last night it was up to 75-80 bpm. It almost felt like her blood pressure was up. This happened right around after dinner. The headache is hanging over into today. It could be still there because she didn't sleep. Her arm is sore still. It isn't serious. The handwriting was bad on her card so it was hard for her to read the lot number. The outcome of the event Headache, sore arm was not resolved, the outcome of the event really tired was resolving, the outcome of the event heart pounding was resolved in Dec2020, while the outcome of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No,,,"['Anxiety', 'Blood pressure increased', 'Blood pressure measurement', 'Fatigue', 'Headache', 'Heart rate', 'Heart rate increased', 'Insomnia', 'Pain in extremity', 'Palpitations']",UNK,PFIZER\BIONTECH, 921291,MD,68.0,F,"arm was hurting/very sore arm; have a really bad headache; teeth ache; muscle and joint pain; muscle and joint pain; chills; low grade fever 99.7; sore throat; congestion; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 3 ug/ml) Batch/lot number: EL1284, on 29Dec2020 12:33 single dose on left arm for COVID-19 immunization. Medical history included Blood pressure high which diagnosed a long time ago, probably when she was 45 years old, though it could have been when she was 42 or 43, probably earlier, 25 years ago, so put when she was 42; hemochromatosis diagnosed about 25 years ago; Arthritis; Cluster headaches; low thyroid and she didn't take medication for this, it wasn't low enough; COVID-19 in Mar2020. Concomitant medication was none. The patient received the Pfizer covid vaccine yesterday (29Dec2020) and she called the line to report the side effects today. She said she had covid around the Easter time and donated her plasma also for antibodies. She said after getting the vaccine yesterday she was feeling worse, have a really bad headache, teeth ache, arm was hurting woke up due to that in the night, really bad headache, muscle and joint pain, chills , low grade fever 99.7 , sore throat and congestion. The patient received the vaccine through work, and was not prescribed it from a provider. She had her shot at 12:33PM yesterday (29Dec2020), after lunch. Her vaccine was given to her at the hospital where she worked, which was not a military hospital. Her side effects were that she developed a headache, also her teeth were aching, and then last night around 04:00AM in the morning she woke up with a very sore arm and worse headache. She said she also had muscle and joint pains, chills, and fever. She said now she still had a headache, and still didn't feel good. Treatment received for the events included Ibuprofen and Tylenol. Ibuprofen was clarified to being generic Ibuprofen prescription in a pharmacy bottle with EXP 3 09Mar2021 and NDC: 67877032005. She said that the strength of this medication is 600mg, and she just took one last night by mouth at about four in the morning. She says she also took Tylenol before bed, 500mg, this is the name brand product. UPC/LOT/EXP: unknown, she didn't have it with her she said it was in date and was brand new, in to go packs. She said that her teeth aching was gone, she still had her headache, muscle pain, fever, and her arm hurt. She said she did take another Tylenol a half hour ago or 45 minutes ago. Her low grade fever temperature was 99.7 degrees Fahrenheit. She had COVID-19 before, she tested positive for COVID at Easter time, this was in March, they did a PCR nasal swab. She had two positive tests and then a negative test because they had to retest her to get plasma, she had to be negative before she could get plasma. She also had an antibody test a couple months after she had COVID, that showed she had 27 antibodies. She had COVID, then a couple of weeks later she gave plasma, and then a few weeks later had the antibody test that showed she had the 27 antibodies. The outcome of teeth ache was resolved. The outcome of headache, muscle pain, fever, and her arm hurt was not resolved. The outcome of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/01/2020,,PVT,,,"Medical History/Concurrent Conditions: Arthritis; Blood pressure high (diagnosed a long time ago, probably when she was 45 years old, though it could have been when she was 42 or 43, probably earlier, 25 years ago, so put when she was 42); Cluster headaches; COVID-19; Hemochromatosis (Caller says this was diagnosed about 25 years ago.); Thyroid hormones decreased (Caller says she doesn't take medication for this, it isn't low enough.)",,,"['Arthralgia', 'Body temperature', 'Chills', 'Headache', 'Myalgia', 'Nasal congestion', 'Oropharyngeal pain', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 test', 'Toothache']",1,PFIZER\BIONTECH, 921292,OK,66.0,F,"Headache, Extreme Fatigue; Headache, Extreme Fatigue; This is a spontaneous report from a contactable Other-HCP. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number Unknown), intramuscular at Left arm on 23Dec2020 10:00 at single dose for covid-19 immunisation. Medical history included Diabetes mellitus, Known allergies: penicillin. Concomitant medication included metformin. The patient experienced headache, extreme fatigue on 23Dec2020 23:00. Both events were non serious. No treatment was received. The patient was not Pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The outcome of the events was resolved in Dec2020. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Diabetes; Penicillin allergy,,,"['Fatigue', 'Headache']",1,PFIZER\BIONTECH,OT 921293,,,M,"Tested positive for COVID-19; Tested positive for COVID-19; Sick; He got the chills and later came down with muscle aches and fatigue; He got the chills and later came down with muscle aches and fatigue; He got the chills and later came down with muscle aches and fatigue; His arm was sore for a day; This is a spontaneous report from a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. A non-contactable consumer reported for a 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced his arm was sore for a day on 18Dec2020 but he suffered no other side effects. Six days later on Christmas Eve (24Dec2020), after working a shift in the COVID-19 unit, the patient became sick. He got the chills and later came down with muscle aches and fatigue. The day after Christmas (26Dec2020), he went to a drive-up hospital testing site and tested positive for COVID-19. The patient was feeling better since his symptoms peaked on Christmas Day but still felt fatigued. The outcome of event fatigue was not recovered, the outcome of the events sick, chills, muscle aches was recovering, the outcome of other events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,UNK,,,,,,"['Chills', 'Fatigue', 'Malaise', 'Myalgia', 'Pain in extremity', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 921294,TN,40.0,F,"eye pain; sensitivity to light; headache/Headache worsened/migraine; This is a spontaneous report from a non-contactable healthcare professional. A 40-year-old female patient received BNT162B2 on 29Dec2020 12:30 at left arm at single dose for COVID-19 immunization. Medical history included chronic kidney disease. Concomitant medications included labetalol, lisinopril, tolvaptan (JYNARQUE), calcium, and ascorbic acid/ferrous fumarate (VITRON C). Patient experienced headache the night on 29Dec2020 21:00 after took the vaccine. Slept the night without much trouble. Headache worsened in the morning, almost felt like a migraine attack with sensitivity to light and eye pain etc. on 30Dec2020. Treatment was not received for these events. Outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,; ; JYNARQUE; ; VITRON C,,Medical History/Concurrent Conditions: Chronic kidney disease,,,"['Eye pain', 'Headache', 'Photophobia']",1,PFIZER\BIONTECH, 921295,CA,31.0,F,Extreme pain in arm for 72 hrs. Continued pain for 2 more days.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,Birth Control,No,No,,No,['Pain in extremity'],UNK,PFIZER\BIONTECH,SYR 921296,OK,52.0,F,"chest tightness; 103.8; Fatigue; body aches; headache; nausea; This is a spontaneous report from a contactable other healthcare professional (HCP). This 52-year-old female HCP reported for herself that she received 1st dose of BNT162B2 intramuscular at left arm on 28Dec2020 08:30 AM for Covid-19 immunization. Medical history included COVID-19 and concomitant drugs were not provided. The patient did not realize vaccine should be taken 90 days after a covid infection tested positive on 12Jan2020. The patient received vaccine on 28Dec2020, she experienced 103.8, fatigue, body aches, headache, nausea, and some chest tightness on 29Dec2020 at 09:00 AM. No treatment was received. The outcome of the events was resolving. The events were reported non-serious. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,,,"Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?:Yes)",,,"['Body temperature', 'Chest discomfort', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 921297,AZ,35.0,F,"2 vesicles appeared on roof of mouth; Red bumps (rash) appeared in mouth; Left arm also very stiff/sore; Left arm also very stiff/sore; This is a spontaneous report from a contactable other healthcare professional (HCP). This 35-year-old female HCP reported for herself that she received BNT162B2 (lot number EH9899) 1st dose Intramuscular at left arm on 27Dec2020 at 12:00 PM for Covid-19 immunization. Medical history was not provided. Concomitant therapy included birth control. The patient experienced red bumps (rash) appeared in mouth, and 2 vesicles appeared on roof of mouth within 24-32 hours after receiving vaccine. Left arm also very stiff/sore for 24 hours after receiving vaccine. Event onset time was reported as 12:00 PM on 28Dec2020. No treatment was received for the events. The outcome of the event was resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/28/2020,1.0,OTH,,,,,,"['Mucosa vesicle', 'Musculoskeletal stiffness', 'Oral mucosal eruption', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 921298,IN,57.0,F,"some swelling on the underside of this same arm; This is a spontaneous report from a contactable consumer(patient). A 57-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685) at single dose via an unknown route in her right arm on 20Dec2020 09:50 for Covid-19 immunization. Medical history and concomitant drug were not provided. Past drug history included a reaction to an antibiotic, cefadroxil (DURICEF). Patient received her initial Covid-19 vaccine in her right arm and noted some swelling on the underside of this same arm on 21Dec2020. She wanted to know if this might be associated with the vaccine. Patient stated she had that got the vaccine on 20Dec2020 at 9:50AM in the right arm, that on Monday the next day, 21Dec2020, she got this swelling under her arm. Patient stated did not know if it had anything to do with that, wanted to know if it is a side effect. Patient stated that the swelling started on Monday the next day, 21Dec2020. Patient stated the swelling has improved but she was going to the doctor to make sure everything was okay. Patient stated that years ago she had a reaction to an antibiotic, cefadroxil. She asked her doctor if she should get the shot because of that and they told her she should, states this happened like 25 years ago as of 30Dec2020, no details known. Outcome of the event was resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/21/2020,1.0,UNK,,,,,,['Peripheral swelling'],1,PFIZER\BIONTECH, 921299,MD,50.0,F,"Red face rash morning of 2 days following vaccine Dull headache, day of vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,PVT,"Enalopril, 25mg Synthroid, 100 micrograms Multivitamin",none,"hypertension, hypothyroidism",,dust,"['Headache', 'Rash', 'Rash erythematous']",1,PFIZER\BIONTECH,IM 921301,,61.0,F,"rash/legs are all rash/checked her back and told her there was a rash; itchy in back; This is a spontaneous report from a contactable healthcare professional. A 61-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 22Dec2020 at left arm at single dose for COVID-19 immunisation. Medical history included ongoing diabetes from about 3-4 years before, and an allergic reaction to the dye when testing heart - couldn't remember the dye put in. She was allergic to that and sent to the ER because her throat was starting to close up about 3 years before. Concomitant medications were none. Patient received the Covid vaccine and developed rash on 24Dec2020 that was worsening and she asked if there was any recommendation on whether this was it going to get worse. Patient received the vaccine and was very worried because she was really itchy in back and her legs were all rash and in her back. She was starting to itch really bad. This was after 2 days of the vaccine (on 24Dec2020). She didn't take note until it came to her back and her friend checked her back and told her there was a rash. She asked if this could be related to the vaccine. She asked was this a severe reaction and should she receive the next dose. Her second dose was scheduled for 08Jan2021. She did not know at this time if she would get the second dose as scheduled or not. Onset of rashes started on her legs; she thought it would go away; but the rashes had worsened; they were now on her back and were getting really itchy; she had a friend look at it who told her she had patches of rashes on her back. She reported that she was going to contact her doctor about this information because she was scared about the rashes. Outcome of the events was not resolved. Lot/Batch and Expiration date has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/24/2020,2.0,UNK,,Diabetes,Medical History/Concurrent Conditions: Allergy to chemicals (allergic to that and sent to the ER because my throat was starting to close up about 3 years ago),,,"['Pruritus', 'Rash']",UNK,PFIZER\BIONTECH, 921302,NC,38.0,F,"Headache; Hypertension; Face flushed; Extremely tired; Slow Motion; Slurred Speech; This is a spontaneous report from a contactable healthcare professional. A 38-year-old female patient started to receive BNT162B2 (lot number: EJ1685), intramuscularly on 29Dec2020 08:00 at left arm at single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medications were not reported. Patient previously took metronidazole (FLAGYL) and experienced allergy. Patient experienced headache, hypertension, face flushed, extremely tired, slow motion, and slurred speech on 29Dec2020 09:30. Treatment was not received for these events. Outcome of the events was resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Hypertension,,,"['Bradykinesia', 'Dysarthria', 'Fatigue', 'Flushing', 'Headache', 'Hypertension']",1,PFIZER\BIONTECH,OT 921303,FL,42.0,F,"Describes feeling 'weird"". dizzy, slightly SOB, felt large lump in back of throat- felt similar to when she has experienced an allergic reaction. she did not report it to observers but later reported to me after arriving home and still not feeling 100% back to baseline. she stayed in observation area for 40 minutes post vaccine. Reports that she will consult her medical provider to decide if she should take the 2nd dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,,none,none,,Clindamycin- causes anaphylaxis,"['Dizziness', 'Dyspnoea', 'Feeling abnormal', 'Sensation of foreign body']",1,MODERNA,IM 921304,,,F,"I need a root canal, I have pain; a little bit of sour stomach; This is a spontaneous report from a non-contactable Other Health Professional for herself. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose number 1, via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Patient asked can she now take amoxicillin a week after getting first dose? Patient received the first dose on 23Dec2020. Patient though she needs a root canal, she had pain. Patient had a little bit of sour stomach after receiving the COVID 19 vaccine. Patient heard some people got more of a dose than they should have and wound up in the hospital. Action taken in response to the events for BNT162B2 was not applicable. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/01/2020,,UNK,,,,,,"['Dyspepsia', 'Toothache']",1,PFIZER\BIONTECH, 921305,LA,40.0,F,"Rash on legs and arms developed 12-24 hours after vaccine administered. Lasted one day. Treated with OTC medication.; This is a spontaneous report from a contactable consumer. This consumer reported for a 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) on 23Dec2020 at single dose in left arm for covid-19 immunization. Medical history was not reported. Concomitant drug was Spironolactone in two weeks. It was reported that patient experienced Rash on legs and arms developed 12-24 hours after vaccine administered on 23Dec2020. Lasted one day with outcome was recovered. Treated with OTC medication. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not been tested for COVID-19. No Allergies to medications, food, or other products. No follow up attempts are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,,,,,,['Rash'],UNK,PFIZER\BIONTECH, 921306,KS,32.0,F,"Also c/o tingling in hands and feet; dizziness; This is a spontaneous report from a non-contactable other HCP. This other HCP reported for a 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) Intramuscular on 18Dec2020 at single dose in Right arm for covid-19 immunization. Medical history and concomitant drug were not reported. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minutes waiting period after the injection, the patient began to experience dizziness. Also c/o tingling in hands and feet. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, itching and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Treatment included water, granola bar, and rest. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/18/2020,0.0,UNK,,,,,,"['Dizziness', 'Paraesthesia']",1,PFIZER\BIONTECH,OT 921307,WA,48.0,F,"Symptoms: eyelids swelling/itching, nasal/sinus swelling, nasopharyngeal swelling, circumoral swelling-around mouth and lips, not inside mouth. Administered nasal Flonase 2 pumps each nare and 50 mg Benadryl at 2230. At 0430 next morning 12/29, swelling decreased, eyelids remained swollen and minimal swelling in nasal/sinus area. Continued Benadryl 50 mg every 6 hours x 3 doses, by 1900 on 12/29 swelling resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"levothyroxine .05mg/daily, pantoprazole, B-12, milk thistle, calcium, probiotic","respiratory symptoms (covid neg) from 12/20-12/26-mild cough, nasal congestion","diverticulitis, hypothyroidism",,Gentamicin,"['Circumoral oedema', 'Eyelids pruritus', 'Nasal congestion', 'Pharyngitis', 'Swelling of eyelid']",1,PFIZER\BIONTECH,IM 921308,TN,30.0,F,"Body aches; low grade fever; chills, shivering; headache; nausea; stiff/sore arm; stiff/sore arm; This is a spontaneous report from a contactable Other Health Professional for herself. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685) dose number 1, intramuscularly on 26Dec2020 15:30 at single dose on arm Left for COVID-19 immunization. Medical history included irritable bowel syndrome, chicken allergy and COVID-19. Concomitant medications received within 2 weeks of vaccination included clonazepam, spironolactone and melatonin, all from unknown date for unknown indication. Onset of symptoms began roughly 9hrs post vaccine. Lasted roughly 24 hours (28Dec2020). Body aches, low grade fever, chills, shivering, headache, nausea, stiff/sore arm. Adverse event start date: 27Dec2020 00:00. No treatment was received for the events. The action taken in response to the events for BNT162B2 was not applicable. Outcome of the events was resolved on 28Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/27/2020,1.0,PVT,; SPIRONOLACTON;,,Medical History/Concurrent Conditions: Allergy to animal; COVID-19 (if covid prior vaccination: Yes); Irritable bowel syndrome,,,"['Chills', 'Headache', 'Musculoskeletal stiffness', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,OT 921309,,55.0,F,"During her 15 minute waiting period after the injection, the patient began to experience dizziness, anxiety.; During her 15 minute waiting period after the injection, the patient began to experience dizziness, anxiety.; This is a spontaneous report from a non-contactable other health professional. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899) dose number 1, intramuscularly on an unspecified date at single dose on left arm (left deltoid muscle) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She had no history of previous hypersensitivity reactions to immunizations. During her 15 minutes waiting period after the injection, the patient began to experience dizziness, anxiety. She denied rash, hives, difficulty breathing, difficulty swallowing, throat tightness, hoarseness, itching, facial swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency. Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea and increased work of breathing, vomiting and abdominal pain. Planned action included: observation, serial examination. The action taken in response to the events for BNT162B2 was not applicable. Outcome of the events was unknown. Assessment by reporter: transient anxiety associated with COVID vaccine administration. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Anxiety', 'Dizziness']",1,PFIZER\BIONTECH,OT 921310,TX,27.0,F,"Experienced muscle aches and redness at site of injection, body aches overall, and fever. I was tested for covid-19, flu, and a urinalysis was performed. All tests gave negative results. Ibuprofen was recommended for symptom management.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,PVT,Femynor,none,none,,Cipro,"['Influenza virus test negative', 'Injection site erythema', 'Myalgia', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Urine analysis normal']",1,PFIZER\BIONTECH,SYR 921311,MN,53.0,F,"feeling tingling on right side of tongue and part of inside of mouth; Felt some light tingling on the Right side of shoulder and up into neck and ear; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; pain in right shoulder and back of neck into back of head; This is a spontaneous report from a contactable nurse for herself. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), intramuscular on 30Dec2020 10:15 at single dose on right arm for covid-19 immunisation. Medical history included hypothyroid, migraines and sulfa allergy. Concomitant medications included propranolol, topiramate (TOPAMAX), levothyroxine, bupropion hydrochloride (WELLBUTRIN) and levocetirizine dihydrochloride (XYZAL), all from unknown date for unknown indication. At 10:30 on 30Dec2020 (also reported as ""about 5 minutes after shot""), patient started feeling tingling on right side of tongue and part of inside of mouth. Felt some light tingling on the Right side of shoulder and up into neck and ear. The tingling resolved, but few hours after the shot, have pain in right shoulder and back of neck into back of head. No treatment was received for the events. Action taken in response to the event was not applicable. Outcome of feeling tingling on right side of tongue and part of inside of mouth, felt some light tingling on the Right side of shoulder and up into neck and ear was resolved. Outcome of pain in right shoulder and back of neck into back of head was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,; TOPAMAX; ; WELLBUTRIN; XYZAL,,Medical History/Concurrent Conditions: Hypothyroidism; Migraine; Sulfonamide allergy,,,"['Arthralgia', 'Headache', 'Neck pain', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,OT 921312,NJ,56.0,F,"Pfizer-BioNTech COVID-19 Vaccine Patient received COVID-19 vaccine on 12/30/2020 at 7:21am and about 3 minutes later, experienced nausea, dizziness and weakness. Patient was brought to ED to be evaluated @ 07:35 am. Ondansetron 4mg inj was given at 8:29am and NS 1000 mL was given over 2 hrs at 8:30am. Patient felt better and tolerating oral at 09:19 am and discharged at 9:25am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"losartan 50 mg, pregabalin 50 mg, sertraline 25 mg",none,"asthma, hypertension, family history of breast cancer and pancreatic cancer, hyperlipidemia, fibromyalgia, gall bladder polyp",,NKA,"['Asthenia', 'Blood glucose normal', 'Blood magnesium normal', 'Differential white blood cell count normal', 'Dizziness', 'Electrocardiogram normal', 'Full blood count normal', 'Metabolic function test normal', 'Nausea', 'Troponin I normal']",1,PFIZER\BIONTECH,IM 921313,NC,61.0,F,"Headache; muscle aches and pains; feels like she is getting a fever; thinks she is having the chills; feeling a little warm/ She is cold, too; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) intramuscular on left arm, near the top (in the muscle), at single dose for vaccination on 29Dec2020 at 12:45 pm at 61-year-old. Medical history included: hay fever allergies, allergic to prochlorperazine maleate (COMPAZINE). Concomitant medication was not reported. No additional vaccines administered on same date of the Pfizer vaccine. On 30Dec2020, the patient stated her headache started about an hour and a half ago. She started having the muscle aches and pains when she woke up this morning. She felt like she was getting a fever, but she was at work and couldn't take her temperature. She was feeling a little warm, she was cold, too. She was having the chills. The patient confirmed all of these symptoms just started happening this morning (30Dec2020). No emergency room nor physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,MIL,,,Medical History/Concurrent Conditions: Hay fever,,,"['Chills', 'Feeling of body temperature change', 'Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,OT 921314,SC,49.0,F,"she had a slight headache that turned into a bad headache; threw up/ vomited; Nausea; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received one dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER5730) via unspecified route on right upper arm single dose for COVID-19 immunization on 30Dec2020 before 10:30AM, at 49-year-old. Medical history and concomitant medication were not reported. On 30Dec2020, 20 minutes after getting the vaccine, the patient had a slight headache that turned into a bad headache by 11AM. Then she went to lunch at 11:30, and after she ate something, she took ibuprofen, then got back from lunch, worked an hour, and threw up. She vomited between 1 and 1:30PM, and vomited a few times and was done, but could still feel a little nausea, but was not going to go throw up. She checked her temperature but didn't have one. Action taken for BNT162B2 was not appliable. Outcome of the event headache was resolving, outcome of the event threw up/ vomited was resolved on 30Dec2020, outcome of the other event was unknown. It was reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,,,,,,"['Body temperature', 'Headache', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH, 921315,NC,,F,"Tachycardia; Tingling in the tongue; This is a spontaneous report from a Pfizer-sponsored program. A contactable female physician (patient) of unspecified age reported herself received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on 21Dec2020. Medical history and concomitant medication were not reported. 2-3 hours after the vaccination (21Dec2020), the patient experienced tachycardia. She took diphenhydramine (BENADRYL) 25 IM. It went up and down before it settled down. She also had experienced tingling in the tongue on 21Dec2020. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown. It was reported as non-serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/21/2020,0.0,UNK,,,,,,"['Paraesthesia oral', 'Tachycardia']",UNK,PFIZER\BIONTECH, 921316,IN,48.0,F,"12 hours after administration of the vaccination (1 am) I awakened in the middle of the night with teeth chattering chills, I felt extremely cold (hard to warm up), my hands were numb (especially the left hand, but I got the shot in the right arm) . I had severe muscle aches, it was hard to walk. i felt extremely thirsty and my lips were dry. 13-14 hours after the shot. I still felt cold but was less shaky and teeth no longer chattering. hard to walk, felt wobbly, I was a little dizzy. I felt like I was having muscle spasms even in my pelvic floor. still thrirsty. 17 hours felt warm and sweaty, but not having feverish feelings. very tired 19 hours sore and very tired. 28 hours finally felt more normal and less tired.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,"singulair, nifedipine, zinc, vit d, vit c, magnesium, alpha lipoic acid, prenatal vitamin claritin",none,asthma high blood pressure obesity,,ibuprofen and aleve,"['Balance disorder', 'Chills', 'Dizziness', 'Fatigue', 'Feeling cold', 'Feeling hot', 'Gait disturbance', 'Hyperhidrosis', 'Hypoaesthesia', 'Lip dry', 'Muscle spasms', 'Myalgia', 'Pain', 'Sleep disorder', 'Thirst']",1,MODERNA,IM 921317,,,F,"having a brief, weird sense of smell; she felt lightheaded; having an arm slightly sored; facial tension; anxiety; This is a spontaneous report from a contactable nurse (patient). This (age: 62; unit: unknown) female nurse reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm on 21Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Nurse stated receiving the COVID-19 vaccine last Monday (21Dec2020), after which she experienced immediate and random side effects. She explained having a brief, weird sense of smell, then within three minutes, she felt lightheaded which was strong for 15 minutes and went away within 30 minutes. She specified that the lightheadedness didn't feel like anxiety. She mentioned having an arm slightly sored and a facial tension which also occurred within that 30 minutes period. She added having an other symptom, but didn't specify it, saying that she wasn't certain if her symptoms were related to the vaccine or to anxiety. She expressed being reluctant to receiving the second dose of the vaccine. She then asked if her symptoms were commonly reported side effects of the COVID-19 vaccines. It was reported as non-serious. Outcome of events weird sense of smell and lightheaded was recovered, and the rest of events was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/01/2020,,UNK,,,,,,"['Anxiety', 'Dizziness', 'Hypertonia', 'Parosmia', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 921318,KY,46.0,M,"Severe allergic reaction; BP of 170/104; felt like his whole body was on fire; chest tightness; HR elevated at 110bpm; Severe allergic reaction with symptoms that include/ rash all over his body including his throat, chest, and inner legs.; Right side of neck was swollen and sore; Right side of neck was swollen and sore; his neck was stiff to turn; he feels ""really weak and tired""; he feels ""really weak and tired""; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19. The patient's medical history and concomitant medications were not reported. Patient is a 46y/o male certified nursing assistant (CNA). He received his first dose of Pfizer-Biontech Covid19 vaccine, yesterday 29Dec2020. On an unspecified date in Dec2020, patient experienced severe allergic reaction with symptoms that include: felt like his whole body was on fire, chest tightness, BP of 170/104, HR elevated at 110 bpm, rash all over his body including his throat, chest, and inner legs. Right side of neck was swollen and sore. Both sides are swollen, today, and his neck was stiff to turn, he feels ""really weak and tired"". Patient was taken by ambulance to the emergency room. Patient then asked if he should get the second dose of the vaccine. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of severe allergic reaction with multiple symptoms cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/01/2020,,UNK,,,,,,"['Asthenia', 'Blood pressure increased', 'Burning sensation', 'Chest discomfort', 'Fatigue', 'Heart rate increased', 'Hypersensitivity', 'Musculoskeletal stiffness', 'Neck pain', 'Rash', 'Swelling']",1,PFIZER\BIONTECH, 921319,NY,57.0,F,"12/28 sore arm, nausea, 12/29 slight headache, fatigue and nasal congestion, 12/31 Red pin dot rash on abdomen and large hives on back, headache subsided . Hydrocortisone 1% applied to rash and itchiness subsided within 24hr. 1/03/21 headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/27/2020,12/28/2020,1.0,PVT,,,,,,"['Fatigue', 'Headache', 'Nasal congestion', 'Nausea', 'Pain in extremity', 'Rash', 'Rash erythematous', 'Urticaria']",1,MODERNA,IM 921320,IL,63.0,F,"significant fatigue; temperature was taken when waking up - 101F orally; she slept more; localized injection site pain and redness; localized injection site pain and redness; This is a spontaneous report from a contactable nurse (patient). This 63-year-old female Nurse reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular at right arm on 17Dec2020 08:30 PM at single dose for COVID-19 immunization. Facility type of vaccine was hospital. Medical history included shingles in Jun2020 after illness that mimicked COVID-19 but all tests came back negative - was sick for 3 weeks; no other chronic health conditions; severe beef/pork allergy - anaphylaxis. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medications were not reported. No other vaccine in four weeks. On 18Dec2020 02:00 PM, patient experienced significant fatigue; she slept for 1 hour and temperature was taken when waking up - 101F orally; she slept more; she had localized injection site pain and redness for 3-5 days. No treatment was received for events. It was reported as non-serious. Outcome of events was recovered in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Anaphylaxis; Meat allergy (anaphylaxis); Shingles (Shingles in Jun2020 after illness that mimicked COVID-19 but all tests came back negative); Sickness (but all tests came back negative - was sick for 3weeks. No other chronic health conditions.),,,"['Body temperature', 'Body temperature increased', 'Fatigue', 'Hypersomnia', 'SARS-CoV-2 test', 'Vaccination site erythema', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 921321,IA,40.0,F,"About 10 mins after I noticed some tingling and numbness on the right side of my head (ear and cheek were numb). I also had some numbness on the top of my thigh. I sat for monitoring for a couple hours and was sent home. The tingling moved to the back of my head for a little while last night and seemed to had resolved before I went to bed around 10p. The tingling seems very minimal this morning...on a scale of 1-10, 10 being the most noticeable, yesterday was a 10. Today seems to be a 1 or 2. Only noticeable if I am sitting still and be more along my ear and not my head or shoulder. There is still the weird feeling (similar to numbness) in my face and my thigh. My face is getting better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Feeling abnormal', 'Hypoaesthesia', 'Paraesthesia', 'Sensory loss']",1,PFIZER\BIONTECH,IM 921323,IL,52.0,F,"Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if I was given IV contrast Dye; Thirst; Hunger; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular at left arm on 17Dec2020 04:30 PM at single dose for COVID-19 immunization. The facility type of vaccine was hospital. Medical history included diabetes, HTN, vertigo, sleep apnea, colonic diverticulitis, fibroid uterus, left cystic breast; pulmonary valve prolapse. No known allergies. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medication included atorvastatin; metformin; eplerenone; HCTZ; levonorgestrel (MIRENA); ascorbic acid, biotin, calcium carbonate, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (BEROCCA) for supplement; montelukast sodium (SINGULAIR); loratadine (CLARITIN). No other vaccine in four weeks. On 17Dec2020, patient experienced palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if being given IV contrast dye; thirst; hunger. No treatment for events. It was reported as non-serious. Outcome of events was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,; ; ; HCTZ; MIRENA; BEROCCA [ASCORBIC ACID;BIOTIN;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;NICOTINAMIDE;PYR; SINGULAIR; CLARITIN [LORATADINE],,Medical History/Concurrent Conditions: Breast cyst; Colon diverticulitis; Diabetes; Hypertension; Pulmonary valve disorders; Sleep apnea; Uterine fibroids; Vertigo,,,"['Feeling hot', 'Flushing', 'Hunger', 'Limb discomfort', 'Palpitations', 'Thirst']",1,PFIZER\BIONTECH,OT 921324,VA,,F,"Developed tachycardia around 12:55 pm; This is a spontaneous report from a contactable other HCP (Patient). A 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EH9899) via an unspecified route of administration in left arm on 28Dec2020 07:55 at single dose for COVID-19 immunization. Medical history included asthma, GERD, vestibular migraines, Penicillin allergy. Concomitant medication included famotidine (PEPCID), ergocalciferol (VITAMIN D), magnesium, multivitamin. The patient previously took Relafen and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the vaccine around 28Dec2020 7:55 am. Developed tachycardia around 28Dec2020 12:55 pm and EMS was called. She was evaluated at the ER on 28Dec2020 and 29Dec2020. Saw cardiologist on 29Dec2020. Currently wearing Holter monitor and will need ECHO. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was received for the adverse event. Event outcome was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,PEPCID [FAMOTIDINE]; ; VITAMIN D [ERGOCALCIFEROL]; MULTIVITAMIN [VITAMINS NOS],,Medical History/Concurrent Conditions: Asthma; GERD; Penicillin allergy; Vestibular migraine,,,['Tachycardia'],1,PFIZER\BIONTECH, 921325,NY,27.0,F,10 minutes post vaccination patient reported to clinic observation staff that she felt warm and flushed. Her face was red. We transported her to our on-site emergency room for evaluation.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,NONE,NONE,NONE,,NONE,"['Erythema', 'Feeling hot', 'Flushing']",1,MODERNA,IM 921326,MA,65.0,F,"fever; chills; headache; nausea; General malaise 22Dec./ On 24Dec malaise; This is a spontaneous report from a contactable Nurse (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left arm on 21Dec2020 17:30 at single dose for COVID-19 immunization. Medical history included Crohns disease, Penicillin allergy. The patient previously took nystatin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient received other unspecified medications within 2 weeks of vaccination. The patient experienced general malaise 22Dec2020. On 23Dec2020, experienced fever, chills, headache, and nausea. On 24Dec2020, experienced malaise. No treatment received for the adverse events. Events outcome was recovered on Dec2020. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Crohn's disease; Penicillin allergy,,,"['Chills', 'Headache', 'Malaise', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,OT 921327,AZ,50.0,F,"underneath my armpit is a little bit swelling; arm hurt a little bit more; headache; body hurting her; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH5730), via an unspecified route of administration on 28Dec2020 at single dose for Covid-19 immunisation. There were no medical history nor concomitant medications. The consumer received the vaccine on the 28Dec2020. She doesn't have a prescribing doctor. During the night after receiving the vaccine, her body was hurting her on 28Dec2020. She started to develop side effects 4-5 hours after receiving the vaccine. The side effects started during the evening the same day she got the shot. On 29Dec2020, the side effects were worse, she had a headache, and her arm hurt a little bit more. She then realized under her armpit was swollen a little bit / underneath her armpit was a little bit swelling on 30Dec2020. She talked to someone earlier about this and they told her to call her doctor. She had a lot of headaches. Everything is hurting her. The outcome of under her armpit was swollen a little bit was not recovered, of her arm hurt a little bit more was unknown. The outcome of the other events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Headache', 'Pain', 'Pain in extremity', 'Swelling']",1,PFIZER\BIONTECH, 921328,TX,61.0,F,"Feeling dizzy, shakiness, and face pulsing. States ""I fell like lost control of my body."" Denies nausea, shortness of breath, reash, or itching. She did have hives when she was given a flu shot last year.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,unknown,unknown,,Rash after Flu vaccine in 2019,none listed,"['Blood glucose', 'Dizziness', 'Facial discomfort', 'Feeling abnormal', 'Tremor']",1,MODERNA,IM 921329,LA,68.0,M,"tenderness/tenderness and soreness is at the injection site; soreness/body aches; muscle aches; flu like symptoms; injection site soreness; Stiff neck; This is a spontaneous report from a contactable other HCP (patient). This 68-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), on 29Dec2020 at single dose in the right deltoid for More protection and prevention. Medical history included blood cholesterol abnormal. The patient had the virus before. He has positive antibodies. Concomitant medication included atorvastatin, 5mg or 10mg he can not recall, Once a day, Started this about 10-15 years ago and ongoing, To control cholesterol levels. He received Covid vaccine on 29Dec2020 and was experiencing some tenderness, soreness, muscle aches, and flu like symptoms. When he says flu like symptoms, he has no fever but it is more like how a person feels when they are first starting to get the flu with the body aches and sore muscles. The tenderness and soreness is at the injection site, it was given in the right deltoid. Injection site soreness: Feels like he got punched really hard. Is not bruising. Very sensitive and tender. He has been moving his arm and getting the muscle to function. This started a couple hours after getting the shot. It was given in the right arm since he is right handed with the rationale that using his arm would help with the soreness. Achy muscles and stiff neck: Got these later on 29Dec2020. On a scale from 0-10, it would be around a 3-5. It is getting slightly better. He had this same response when he got his first flu vaccine a few years ago. The flu-like symptoms, the body aches and sore muscles, started on afternoon on 229Dec2020. The shot was administered about 10:15- 10:30am on 29Dec2020. The events are getting better, definitely not getting worse for sure. He has experienced injection site soreness and flu like symptoms: achy muscles and stiff neck, with no fever. Weight: Between 197-198. The outcome weas recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Blood cholesterol abnormal,,,"['Influenza like illness', 'Investigation', 'Musculoskeletal stiffness', 'Myalgia', 'Pain', 'SARS-CoV-2 antibody test', 'Vaccination site pain', 'Weight']",1,PFIZER\BIONTECH, 921330,GA,35.0,M,"tachycardia with mild exertion; Baseline HR elevated; dyspnea; palpitation; chest tightness; This is a spontaneous report from a contactable physician (patient). A 35-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EJ1685) via an unspecified route of administration in left arm on 29Dec2020 15:30 at single dose for COVID-19 immunization. There was no medical history, no known allergies, no allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no any other medications the patient received within 2 weeks of vaccination. On 29Dec2020, 3 minutes following vaccine injection - dyspnea, palpitation and chest tightness; lasted 3-4 minutes. 24 hours later (30Dec2020) - dyspnea and tachycardia with mild exertion (1 flight of stairs). Baseline HR elevated. No treatment was received for the adverse events. Events outcome was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chest discomfort', 'Dyspnoea', 'Heart rate', 'Heart rate increased', 'Palpitations', 'Tachycardia']",1,PFIZER\BIONTECH, 921331,MA,58.0,F,"Employee received COVID-19 vaccine on 12/28/20. Reports doing well until this morning. Woke up feeling itchy around injection site (left upper arm). Reports area feels tender and with mild burning to touch. Arm is sore at injection site but able to perform daily normal activities. RN observed a red, raised, localized rash to left upper arm. Rash extends about 10 centimeters below injection site. Rash is localized and no other concerns at this time. RN advised to avoid touching or scratching the area. Cold compresses and OTC cortisone cream if it gets itchy again. Instructed to monitor and report any new or worsening symptoms. Instructed to seek immediate medical care if any hives or breathing issues develop. Patient voiced understanding and agreement with plan.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,,,,,No known allergies.,"['Burning sensation', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site reaction', 'Injection site swelling', 'Rash erythematous', 'Tenderness']",1,MODERNA,IM 921332,AR,65.0,F,"She thought maybe she had food poisoning bc of the weird symptoms; headache; achy muscles; loose stools; sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), on 20Dec2020 at single dose for covid-19 immunisation. Medical history included None. There were no concomitant medications. The patient experienced loose stools on 25Dec2020, headache on 26Dec2020, achy muscles on 26Dec2020, sore arm on 20Dec2020, she thought maybe she had food poisoning bc of the weird symptoms on an unspecified date. She initially had a sore arm and the usual effects which she expected. Then, about six days into it she started having a headache and achy muscles. It all started with loose stool. She did get a COVID test because of signs of COVID. But it was negative. She thought maybe she had food poisoning bc of the weird symptoms. The headaches were bad, but they were not as bad currently. She had a loose stool that lasted a couple of days. The headaches were really mild currently. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Dec2020. Outcome of loose stools, sore arm was recovered in Dec2020, headache was recovering, achy muscles was not recovered, other was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/20/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Diarrhoea', 'Food poisoning', 'Headache', 'Myalgia', 'Pain in extremity', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 921333,,,F,"mild pain; an erythematous area on her left deltoid, it as a welt; This is a spontaneous report from a contactable physician reported for herself. This female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is an Emergency Room physician who received the vaccine on 17Dec2020 and had mild pain only for 36 hours after the injection. She never had any redness after her injection until day 12 she noticed an erythematous area on her left deltoid, it as a welt. The physician would like to know if she should get the 2nd dose of COVID-19 considering she had a delayed reaction to the first dose. The outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,,,UNK,,,,,,"['Pain', 'Vaccination site erythema']",1,PFIZER\BIONTECH, 921334,,,F,"severe local reaction; not just a strong bicep inflammation, but it extended out to the shoulder and the back of the neck; not just a strong bicep inflammation, but it extended out to the shoulder and the back of the neck; This is a spontaneous report from a non-contactable physician (patient). This 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient experiencing a ""severe local reaction"" following the first dose of the vaccine. She described it as: not just a strong bicep inflammation, but it extended out to the shoulder and the back of the neck. The outcome was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Inflammation', 'Local reaction', 'Tendonitis']",1,PFIZER\BIONTECH, 921335,,,F,"potential person infected with Sars-Cov-2 following the administration of the first dose of vaccine and was isolated during the timing of the second dose; potential person infected with Sars-Cov-2 following the administration of the first dose of vaccine and was isolated during the timing of the second dose; This is a spontaneous report from a contactable Pharmacist. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The pharmacist was questioning as to guidelines to the potential person infected with Sars-Cov-2 following the administration of the first dose of vaccine and was isolated during the timing of the second dose. The outcome of the event was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: The reported potential person infected with Sars-Cov-2 following the administration of the first dose of vaccine is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Suspected COVID-19'],1,PFIZER\BIONTECH, 921336,PA,35.0,F,"Headache; Fatigue; Muscle and joint pain; joint pain; Chills; heat surges; Sore throat; Not wanting to eat; Sore; Heart bothered me a little today; This is a spontaneous report from a contactable other Health Professional (Other HCP) (patient). A 35-year-old female Patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Ek9231) on 29Dec2020 10:30 AM, Intramuscularly, (vaccine location: Left arm) at single dose (first dose) for COVID-19 immunization. Medical history included Mitral valve prolapse (Mvp) and covid (patient had covid prior vaccination). Concomitant medication included naproxen a week before. Patient was allergic to Azithromycin. Patient received no other vaccine in four weeks. Patient experienced Headache, Fatigue, Muscle and joint pain, Chills and heat surges, Sore throat, Not wanting to eat, Sore, Heart bothered me a little today (29Dec2020 11:15). Patient did not receive any treatment. Patient did not have had covid tested post vaccination. The outcome of the events was unknown. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,,,Medical History/Concurrent Conditions: COVID-19 (Field Name: If covid prior vaccination Field Value: yes); Mitral valve prolapse (Mvp),,,"['Arthralgia', 'Cardiac disorder', 'Chills', 'Decreased appetite', 'Fatigue', 'Feeling hot', 'Headache', 'Myalgia', 'Oropharyngeal pain', 'Pain']",1,PFIZER\BIONTECH,OT 921338,AL,46.0,F,"flushing; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female (not pregnant) patient received BNT162B2 (lot number EH 9899) first dose intramuscularly on right arm on 30Dec2020 09:30 AM at single dose for COVID-19 immunization. Medical history included HTN/GERD, allergies to pineapple and sulfa. Concomitant medications in two weeks included diltiazem (CARDIZEM), valsartan (DIOVAN), omeprazole (PROTONIX), meloxicam (MOBIC), docusate and bupropion hydrochloride (WELLBUTRIN). No other vaccine in four weeks. Patient experienced flushing, chest pressure and lightheadedness on 30Dec2020 09:30 AM, resulted in: Emergency room/department or urgent care and received treatment as ER evaluation. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovered in Dec2020. The seriousness was reported as no.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,CARDIZEM [DILTIAZEM]; DIOVAN; PROTONIX [OMEPRAZOLE]; MOBIC; ; WELLBUTRIN,,Medical History/Concurrent Conditions: Fruit allergy; GERD; Hypertension; Sulfonamide allergy,,,"['Chest discomfort', 'Dizziness', 'Flushing']",1,PFIZER\BIONTECH,OT 921339,FL,37.0,M,"Headaches; body aches; Injection site pain; This is a spontaneous report from a contactable Pharmacist (patient). A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. The patient experienced headaches and body aches, injection site pain, on 29Dec2020 at 08:00 AM. The patient had Acetaminophen as the treatment for the events. The patient stated that no other vaccine in four weeks and no other medications in two weeks. No Covid prior vaccination and no Covid tested post vaccination. The outcome of the events was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/29/2020,,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Headache', 'Pain', 'Vaccination site pain']",1,PFIZER\BIONTECH, 921340,CO,38.0,M,"received the vaccine on 12/16/20 - On 12/18/20, he developed a low-grade fever, chills, body aches, and felt fatigued",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/18/2020,2.0,PVT,not avl to this reporter,not avl to this reporter,not avl to this reporter,,not avl to this reporter,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 921341,AZ,40.0,F,"Headache; Fatigue; Muscle/ joint pain; Muscle/ joint pain; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Eh9899) Intramuscularly on 26Dec2020 10:30 AM (Anatomical Location: Arm Left) at single dose (first dose) for COVID-19 immunization. Medical history and concomitant medications were reported none. Patient did not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Headache, Fatigue, Muscle/ joint pain on 26Dec2020 12:30 PM. Patient did not receive any treatment. The outcome of the events was recovered in unknown date. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia']",1,PFIZER\BIONTECH,OT 921342,WI,27.0,F,"itching, swelling, hives redness, blotchy skin lips & tongue tingling, scratchy throat. Began all upper body and spread to left leg.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,"Vitamin C 500 Mg, Vit D 10K IU daily Tylenol PRN",,CRPS in right hamstring. Anxiety & depression and scoliosis.,,"gabapentin, formaldehyde, gluten, dairy, nuts, beans, beets, broccoli, cabbage, apricots, cloves, liver, scallops, melons. Bronopole, methyldibromoglutaronitrile and cobalt.","['Erythema', 'Paraesthesia oral', 'Pruritus', 'Rash macular', 'Swelling', 'Throat irritation', 'Urticaria']",1,MODERNA,IM 921343,ND,25.0,M,"General Malaise; fatigue; light nausea; light headache; dizziness on and off; blotchy red itchy rash on neck, chest, sides, and back; blotchy red itchy rash on neck, chest, sides, and back; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm on 29Dec2020 at 01:45 PM at single dose for COVID-19 immunization. The relevant medical history included asthma and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?: Yes). Concomitant medications included emtricitabine, tenofovir alafenamide fumarate (DESCOVY), fish oil, vitamin b complex, lisdexamfetamine mesilate (VYVANSE), cetirizine hydrochloride (ZYRTEC), all from Dec2020. The patient experienced general malaise, fatigue, light nausea, light headache, dizziness on and off, several hours later blotchy red itchy rash on neck, chest, sides, and back, lasted for 3-4 hours, all on 29Dec2020 at 07:00 PM. The patient had the most recent COVID-19 vaccine administered at nursing home/senior living facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive treatment for the events. The patient had nasal swab test with unknown results on 30Dec2020. The outcome of the events was recovered with sequel. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,DESCOVY; ; ; VYVANSE; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,"Medical History/Concurrent Conditions: Asthma; COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?:Yes)",,,"['Dizziness', 'Fatigue', 'Headache', 'Investigation', 'Malaise', 'Nausea', 'Rash macular', 'Rash pruritic']",1,PFIZER\BIONTECH,OT 921344,MI,40.0,F,"Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; This is a spontaneous report from a contactable Nurse (patient). A 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EK9231) on 23Dec2020 07:15 PM via unknown route of administration (vaccine location: Left arm), at single dose (first dose) for COVID-19 immunization. Medical history was reported none. Concomitant medications included ibuprofen. There were no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not use other vaccine in four weeks. Patient experienced Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in her left hand/fingers and the left side on her lip on 25Dec2020. Patient did not receive any treatment. The outcome of the events was not recovered. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/25/2020,2.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH, 921345,CO,39.0,F,"Administration of vaccine was given about 3 inches too low, not sure if it went into muscle or subcutaneous but I did end up with an injection site reaction 2 days later to include a 2x3 inch red, itchy, raised, hot to the touch welt. Also had extreme dizziness, nausea, headache 2 days after injection. Dizziness, nausea, headache subsided after 24hrs however injection site reaction will go away and come back randomly. Seems to coincide with getting sick? Was fine up until 12/29 when I did end up getting sick to include headache, body aches, chills. I went to go get covid tested which was negative. I ultimately had a sinus/ear infection. However injection site reaction had gone away UNTIL I got sick on 12/29 then it showed up again and still have it as of today.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/21/2020,3.0,PVT,Metformin 1000 mg BID Amitriptyline 25 mg Qhs Propranolol 40 mg BID Excedrine Migraine PRN,None,Type II Diabetes Migraines Solitary Kidney,,Morphine Septra,"['Chills', 'Dizziness', 'Ear infection', 'Headache', 'Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Injection site recall reaction', 'Injection site swelling', 'Injection site urticaria', 'Injection site warmth', 'Malaise', 'Nausea', 'Pain', 'Product administered at inappropriate site', 'SARS-CoV-2 test negative', 'Sinusitis']",2,PFIZER\BIONTECH,IM 921346,,,F,"costochondral soreness and pain, midsternal; left shoulder joint achiness; This is a spontaneous report from a contactable nurse (patient). A female patient of unspecified age received BNT162B2 on 19Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was having an unusual symptom. She cannot find this symptom in the clinical trials and would like to know if it occurred in the trials. She started having spontaneous costochondral soreness and pain, midsternal, on 27Dec2020, following left shoulder joint achiness on the 24Dec2020 through 26Dec2020. The outcome of the events was unknown. Information on Lot/batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/24/2020,5.0,UNK,,,,,,"['Arthralgia', 'Musculoskeletal chest pain']",UNK,PFIZER\BIONTECH, 921347,,,M,"Headache; Muscle pain/ache; chills; This is a spontaneous report from a contactable Consumer (Patient's Girlfriend). A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache, muscle pain/ache and chills in Dec2020 (pending for clarification). The reporter was looking for extended adverse events of headache, muscle pain/ache and chills information. Serious criteria was no. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/01/2020,,UNK,,,,,,"['Chills', 'Headache', 'Myalgia']",1,PFIZER\BIONTECH, 921348,IL,35.0,F,"Dizziness; Metallic taste upon injection; Sore arm; Headache; Muscle aches; Fatigue; This is a spontaneous report from a contactable healthcare professional. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on the left arm on 30Dec2020 14:00 at a single dose for COVID-19 immunisation. Medical history included hypertension (List of any other medications the patient received within 2 weeks of vaccination: Hypertension medication). On 30Dec2020 14:00, the patient experienced dizziness, metallic taste upon injection, sore arm, headache, muscle aches and fatigue. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Hypertension (List of any other medications the patient received within 2 weeks of vaccination: Hypertension medication),,,"['Dizziness', 'Dysgeusia', 'Fatigue', 'Headache', 'Myalgia', 'Pain in extremity']",1,PFIZER\BIONTECH, 921349,AR,27.0,M,"Rash to face, fatigue, arm pain to injection site. Took Advil.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,SEN,None,None,None,,None,"['Fatigue', 'Injection site pain', 'Rash']",1,MODERNA,IM 921350,,,F,"slight fever; slight arm pain at vaccination site.; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 53 (units: unknown) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine yesterday. The patient took Tylenol due to slight fever on an unspecified date. She also reported having slight arm pain at vaccination site. Otherwise she reported feeling great. She would like to know if it was okay for her to take Tylenol. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,,,UNK,,,,,,"['Pyrexia', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 921351,TX,22.0,F,"Dizziness; Nausea; Clammy; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on the left arm on 30Dec2020 10:30 at SINGLE DOSE for COVID-19 immunization. Medical history was none and there were no concomitant medications. The patient stated that she got the vaccine at 10:30AM on 30Dec2020, and started to have a feeling of dizziness, nausea, and being clammy about 20 minutes after receiving the vaccine. The patient hasn't done any treatment for these yet. It was also mentioned that dizziness, nausea, and being clammy has pretty much gotten worse (not recovered). Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Cold sweat', 'Dizziness', 'Nausea']",1,PFIZER\BIONTECH, 921352,PA,58.0,F,"Moderate joint pain and stiffness of left shoulder and upper arm (side where injection was given) requiring OTC pain med (Advil or Tylenol) starting 5 days after injection; Moderate joint pain and stiffness of left shoulder and upper arm (side where injection was given) requiring OTC pain med (Advil or Tylenol) starting 5 days after injection; Moderate joint pain and stiffness of left shoulder and upper arm (side where injection was given) requiring OTC pain med (Advil or Tylenol) starting 5 days after injection; This is a spontaneous report from a contactable nurse who reported for herself. A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EJ1685) via an unspecified route of administration on 22Dec2020 at 20:45 (at the age of 58-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included HTN (hypertension), hypothyroidism, and known allergies to PCN (penicillin), sulfa, losartan and lisinopril, all from unspecified dates and unspecified if ongoing. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (taken within 2 weeks of vaccination) included levothyroxine sodium (SYNTHROID), HCTZ and fish oil, all taken for unspecified indications from unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Dec2020 at 09:00, the patient experienced ""moderate joint pain and stiffness of left shoulder and upper arm (side where injection was given) requiring OTC (over the counter) pain med (Advil or Tylenol) starting 5 days after injection."" It was reported that the event was non-serious and did not require hospitalization. The patient did not receive any treatment for the event (also reported that the patient required OTC pain medications for the event). The clinical outcome of the event ""moderate joint pain and stiffness of left shoulder and upper arm (side where injection was given) requiring OTC pain med (Advil or Tylenol) starting 5 days after injection"" was not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/27/2020,5.0,PVT,SYNTHROID; HCTZ;,,Medical History/Concurrent Conditions: Drug hypersensitivity; Hypertension; Hypothyroidism; Penicillin allergy; Sulfonamide allergy,,,"['Vaccination site joint movement impairment', 'Vaccination site joint pain', 'Vaccination site movement impairment']",1,PFIZER\BIONTECH, 921353,TX,42.0,F,"Lymphadenopathy on left axilla and elbow; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 16Dec2020 at 11:45 (at the age of 42-years-old) as a single dose for Covid-19 vaccination. Medical history included cold urticaria and iritis from an unknown date. The patient did have allergies to the medications Sulpha, levaquin, cipro, and macrobid. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for an unknown indications from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Dec2020 at 08:00, the patient experienced Lymphadenopathy on left axilla and elbow. Therapeutic measures were not taken for the Lymphadenopathy on left axilla and elbow. The clinical outcome of the event Lymphadenopathy on left axilla and elbow was recovered on an unknown date in Dec2020. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/20/2020,4.0,PVT,,,Medical History/Concurrent Conditions: Cold urticaria; Iritis; Sulfonamide allergy,,,['Lymphadenopathy'],1,PFIZER\BIONTECH, 921354,CA,37.0,M,"Headache for 18 hours; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 28Dec2020 at 10:15 (at the age of 37-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included hypertension from an unknown date. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications were not reported. The patient did receive other vaccines within 4 weeks prior to vaccination (unspecified). On 28Dec2020 at 11:30, the patient experienced headache for 18 hours. Therapeutic measures were not given for the events. The clinical outcome of the event headache was recovered on an unknown date in Dec2020. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Hypertension,,,['Headache'],1,PFIZER\BIONTECH, 921356,NV,49.0,F,"Headache, anxiety, general feeling of unwellness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,,none,Hashimotos,,Niacin,"['Anxiety', 'Headache', 'Malaise']",1,MODERNA,IM 921357,TX,30.0,F,"Lymphadenopathy; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 29Dec2020 at 13:45 (at the age of 30-years-old) as a single dose for Covid-19 vaccination. Medical history included hypertension from an unknown date. The patient was allergic to penicillin. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient did receive other medications within 2 weeks of the vaccination (unspecified). The patient did not receive other vaccines within four weeks prior to the vaccination. On 30Dec2020 at 15:00, the patient experienced Lymphadenopathy. Therapeutic measures were not taken for the Lymphadenopathy. The clinical outcome of the event Lymphadenopathy was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,,,Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination); Hypertension; Penicillin allergy,,,['Lymphadenopathy'],1,PFIZER\BIONTECH, 921358,MI,35.0,F,"rash that began in my right arm and fingers and over the next week spread to my entire body including my face/ rash is very itchy; The rash is very itchy and swollen; This is a spontaneous report from a contactable nurse, who is also the patient. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: Fl0140), via an unspecified route of administration in the right arm on 17Dec2020 at 15:45 (at the age of 35-years-old) as a single dose for COVID-19 vaccination. The patient had no relevant medical history. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications received within 2 weeks of the vaccination included bupropion hydrochloride (WELLBUTRIN XL) 175mg. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 23Dec2020 at 20:00 the patient broke out in a rash that began in the right arm and fingers and over the next week spread to the patient's entire body including the face. Per the patient the rash was very itchy and swollen. The patient visited an emergency room due to the events. The patient was treated for the events with oral OTC Benadryl and hydrocortisone cream, which the patient stated were not helping. The clinical outcome of the events itchy rash and swelling was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/23/2020,6.0,PVT,WELLBUTRIN SR,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No,,,"['Rash pruritic', 'Swelling']",1,PFIZER\BIONTECH, 921359,CA,51.0,F,"Migraines for several days, nausea on day three; nausea; This is a spontaneous report from a contactable other healthcare professional, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL0140), via intramuscular route of administration in the left arm on 18Dec2020 at 09:00 (at the age of 51-years-old) as a single dose for COVID-19 vaccination. Medical history included fibromyalgia and history of migraines. The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were other medications the patient received within 2 weeks of the vaccination. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 21Dec2020 at 13:00 the patient experienced migraines for several days, nausea on day three. The patient did not receive any treatment for the events. The clinical outcome of the migraines for several days, nausea on day three was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/21/2020,3.0,PVT,,Fibromyalgia; Migraine,,,,"['Migraine', 'Nausea']",1,PFIZER\BIONTECH,OT 921360,MN,52.0,F,"About a half hour after receiving the vaccine I started feeling a numbness under my right eye that progressed slowly progressed to around my right eye, cheek, ear and upper right side of my teeth. I was able to move my muscles (no crooked smile) and close my eyes completely. Today I still have this strange feeling but it's very subtle. This hasn't worsened at all since yesterday but hasn't gone away either.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,none,none,none,,Sulfa,"['Hypoaesthesia', 'Sensory disturbance']",1,PFIZER\BIONTECH,IM 921361,NC,43.0,M,Fatigue and fever on day 5 after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/22/2020,4.0,PVT,"Sertraline, Testosterone cypionate",None,Hypertension,,None,"['COVID-19', 'Fatigue', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 921362,NJ,30.0,F,"12/29/2020 VACCINATION. WAS IN SITTING AREA, FELT FINE. AFTER 20 MINUTES, WALKED OUT OF ROOM AND FELT LIGHT HEADED AND DIZZY. NEAR SYNCOPY EPISODE, TUNNEL VISION, PALE.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,PRENATAL,,,,,"['Dizziness', 'Pallor', 'Presyncope', 'Tunnel vision']",1,PFIZER\BIONTECH,SYR 921363,PA,29.0,F,"Sudden onset of tachycardia and palpitations; Sudden onset of tachycardia and palpitations; tachypnea without SOB; Sudden elevation of BP 178/100; Dizziness; Nausea; skin tingling; This is a spontaneous report from a contactable other healthcare professional, who is also the patient. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EJ1685), via an unspecified route of administration in the left arm on 30Dec2020 at 12:30 (at the age of 29-years-old) as a single dose for COVID-19 vaccination. Medical history included Psoriasis, psoriatic arthritis, exercise induced asthma (no inhalers or treatment for >10 years). The patient had known allergies to methotrexate and chlorhexidine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications received within 2 weeks of the vaccination included apremilast (OTEZLA) 30mg BID (twice a day), bupropion hydrochloride (WELLBUTRIN XL) 300 QD (once a day), and buspirone hydrochloride (BUSPAR) 5mg. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 30Dec2020 at 12:30 the patient experienced sudden onset of tachycardia and palpitations and tachypnea without SOB within 3-5 minutes of injection. The patient also had sudden elevation of BP 178/100, dizziness, nausea, and skin tingling. The patient's BP gradually came down over 60 minutes. The dizziness lasted about 50- 60 minutes. No medication or medical assistance required. The patient was able to drive home. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 27Dec2020, with Test: Nasal Swab and Result: Negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,OTEZLA; WELLBUTRIN XL; BUSPAR,,Medical History/Concurrent Conditions: Exercise induced asthma; Psoriasis; Psoriatic arthritis,,,"['Blood pressure increased', 'Blood pressure measurement', 'Dizziness', 'Nausea', 'Palpitations', 'Paraesthesia', 'SARS-CoV-2 test', 'Tachycardia', 'Tachypnoea']",1,PFIZER\BIONTECH, 921364,AL,,U,"temporary tachycardia; This is a spontaneous report from a contactable physician. This physician reported similar events for 3 patients. This is 1st of 3 reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in Dec2019 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced temporary tachycardia after receiving the vaccine in Dec2019 with outcome of recovered. The reporter monitored the patient using a pulse ox with a heart monitor. Let the patient drink water. She has monitored the patient for about 30 minutes and tachycardia has resolved in 30 to 40 minutes. The reporter was a bit concerned about what to expect and how to prepare for the patient's 2nd dose of the vaccine. The information on the Lot / Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520695 same reporter/event/product, different patient;US-PFIZER INC-2020517983 same reporter/event/product, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Heart rate', 'Oxygen saturation', 'Tachycardia']",1,PFIZER\BIONTECH, 921365,RI,45.0,F,"Full arm became swollen, red, warm to the touch, mimicking a cellulitis-looking infection. Redness was spreading to left lateral neck and across upper chest. Took 50mg chewable Benadryl and 600mg motrin. All symptoms subsided approximately an hour later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,"Cozaar 100mg; hctz 25mg, Zyrtec 10mg",sinusitis,high blood pressure chronic sinusitis obesity,,none,"['Cellulitis', 'Erythema', 'Feeling hot', 'Peripheral swelling']",1,PFIZER\BIONTECH,IM 921366,,,M,"Felt sore throat and tachycardia; Felt sore throat and tachycardia; COVID test came back positive; COVID test came back positive; This is a spontaneous report from a contactable physician, the patient. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 18Dec2020, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. On 28Dec2020, the patient felt sore throat and tachycardia. The patient also reported that on an unspecified date, in Dec2020, the COVID test came back positive (the Sepheid test, not the rapid test). The events were reported as non-serious. The patient underwent lab tests, which included COVID-19 test: positive on an unspecified date in Dec2020. It was unknown if the patient received treatment for the COVID test came back positive, felt sore throat and tachycardia. The clinical outcome of the events the COVID test came back positive, felt sore throat and tachycardia was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the reported events of LOE, COVID 19, Oropharyngeal pain and tachycardia, based on temporal relationship. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/01/2020,,UNK,,,,,,"['Oropharyngeal pain', 'SARS-CoV-2 test positive', 'Tachycardia']",1,PFIZER\BIONTECH, 921367,CA,48.0,F,"This caused immediate pain in the arm. The pain has continued for the past 20 hours.; This is a spontaneous report from contactable Nurse reporting for herself via Pfizer Sales Representative. A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #EJ1685), intramuscular into the right arm on 29Dec2020 11:15 at 0.6 mL, single for COVID-19 immunization. Medical history was none. There were no concomitant medications. The administer cleaned the arm with alcohol but didn't wait for it to dry. On 29Dec2020 the patient experienced immediate pain in the arm. The pain has continued for the past 20 hours. The outcome was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Pain in extremity'],UNK,PFIZER\BIONTECH,OT 921368,AL,,U,"Temporary tachycardia; This is a spontaneous report from a contactable Physician. This physician reported similar events for 3 patients. This is the second of 3 reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced temporary tachycardia on Dec2020 with outcome of recovered. The reporter monitored the patient using a pulse ox with a heart monitor. Let the patient drink water. She has monitored the patient for about 30 minutes and tachycardia has resolved in 30 to 40 minutes. The reporter was a bit concerned about what to expect and how to prepare for the patient's 2nd dose of the vaccine. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520685 Same reporter/drug/event, different patient;US-PFIZER INC-2020517983 Same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Oxygen saturation', 'Tachycardia']",1,PFIZER\BIONTECH, 921369,NC,34.0,F,Estimated due date 06/24/2021. I just had arm pain at the injection site and severe headaches for about 2 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Prenatal vitamins,no,no,,no,"['Exposure during pregnancy', 'Headache', 'Injection site pain']",1,PFIZER\BIONTECH,SYR 921370,,,U,"a high fever; extreme fatigue; have allergies; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the second of eight reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer version of the vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine in Dec2020. The patient had allergies, but it was unknown what the allergies are to. The outcome of events was unknown. No follow-up attempts are possible. Information on batch/Lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520682 same reporter/drug/AE, different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Fatigue', 'Hypersensitivity', 'Pyrexia']",UNK,PFIZER\BIONTECH, 921371,,,U,"high fever; extreme fatigue; patient had allergies, but it was unknown what the allergies are to; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the third of eight reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine on Dec2020. The patient had allergies, but it was unknown what the allergies are to. The outcome of events was unknown. No follow-up attempts are possible. Information on batch/Lot number can not be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520682 same reporter, drug, events, and different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Fatigue', 'Hypersensitivity', 'Pyrexia']",UNK,PFIZER\BIONTECH, 921373,,,U,"high fever; extreme fatigue; patient had allergies, but it was unknown what the allergies are to; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the fourth of eight reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine on Dec2020. The patient had allergies, but it was unknown what the allergies are to. The outcome of events was unknown. No follow-up attempts are possible. Information on batch/Lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520682 same reporter, drug, events, and different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Body temperature', 'Fatigue', 'Hypersensitivity', 'Pyrexia']",UNK,PFIZER\BIONTECH, 921374,,25.0,F,I received COVID vaccine on December 23rd and had tongue swelling one hour later. I took Tylenol and benedryl and swelling went away,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/23/2020,0.0,PVT,,,,,,['Swollen tongue'],UNK,PFIZER\BIONTECH, 921375,,,U,"high fever; extreme fatigue; patient had allergies, but it was unknown what the allergies are to; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the fifth of eight reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer version of the vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 vaccination. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine on Dec2020. The patient had allergies, but it was unknown what the allergies are to. The outcome of events was unknown. No follow-up attempts are possible. Information on batch/Lot number cannot be obtained. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520682 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Fatigue', 'Hypersensitivity', 'Pyrexia']",UNK,PFIZER\BIONTECH, 921376,,,U,"high fever; extreme fatigue; patient had allergies, but it was unknown what the allergies are to; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the sixth of eight reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer version of the vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 vaccination. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine on Dec2020. The patient had allergies, but it was unknown what the allergies are to. The outcome of events was unknown. No follow-up attempts are possible. Information on batch/Lot number cannot be obtained. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520682 same reporter/drug/AE, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Fatigue', 'Hypersensitivity', 'Pyrexia']",UNK,PFIZER\BIONTECH, 921377,AR,60.0,F,"Patient experienced a bit of flushing, itchiness in nose, eyes, tingling in mouth/scalp, and a little throat tightness after initial monitoring period of 15 minutes. Occurred 1-2 hours after dose admin. Resolved with no treatment, though Benadryl was recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Unknown,None,unknown,,"sulfa, quinolones, azithromycin","['Eye pruritus', 'Flushing', 'Nasal pruritus', 'Paraesthesia', 'Paraesthesia oral', 'Throat tightness']",1,PFIZER\BIONTECH,IM 921378,,,U,"high fever; extreme fatigue; patient had allergies, but it was unknown what the allergies are to; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the seventh of eight reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer version of the vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine in Dec2020. The patient had allergies, but it was unknown what the allergies are to. The outcome of events was unknown. No follow-up attempts are possible. Information on batch/Lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520682 same reporter/drug/AE, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Fatigue', 'Hypersensitivity', 'Pyrexia']",UNK,PFIZER\BIONTECH, 921379,,,U,"high fever; extreme fatigue; patient had allergies, but it was unknown what the allergies are to; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the eighth of eight reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer version of the vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine in Dec2020. The patient had allergies, but it was unknown what the allergies are to. The outcome of events was unknown. No follow-up attempts are possible. Information on batch/Lot number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Fatigue', 'Hypersensitivity', 'Pyrexia']",UNK,PFIZER\BIONTECH, 921380,MA,30.0,F,"Lymph node enlargement x 1 node, noticed the morning following vaccine administration. Lymph node in left axillary region. Slightly tender and very mobile; This is a spontaneous report from a contactable nurse, the patient. A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; ; Lot number: EH9899), via an unspecified route of administration, in the left arm, on 22Dec2020 at 12:15 PM (at the age of 30-year-old) as a single dose for COVID-19 immunization. Medical history included irritable bowel syndrome, anxiety, depression, allergies to dust, cats and dogs. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included sertraline hydrochloride (ZOLOFT), melatonin, and l-theanine. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 9:00 AM, the patient experienced lymph node enlargement x 1 node, noticed the morning following vaccine administration. Lymph node in left axillary region. Slightly tender and very mobile. The event was reported as non-serious. On 29Dec2020 the patient underwent lab tests, which included SARS-CoV-2 test (nasal swab) and SARS-CoV-2 test (PCR, covid test): both of which were negative. The patient did not receive any treatment for lymph node enlargement x 1 node, noticed the morning following vaccine administration. Lymph node in left axillary region. Slightly tender and very mobile. The patient reported that its still present 8 days later remains about 2 finger widths wide and is firm/dense, mobile, now nontender. The clinical outcome of the event lymph node enlargement x 1 node, noticed the morning following vaccine administration. Lymph node in left axillary region. Slightly tender and very mobile was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,WRK,ZOLOFT; ; L-THEANINE,,Medical History/Concurrent Conditions: Allergy to animals; Anxiety; Depression; Dust allergy; Irritable bowel syndrome,,,"['Lymphadenopathy', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 921381,NJ,32.0,M,"Light headed, felt feverish but body temperature was 97.4 F, felt like heart rate was elevated. Resolved after 20-30 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,"Sertraline, levocetirizine, monteleukast, famotidine",,Casein intolerance Environmental allergies Generalized anxiety,"Rabies vaccine age 27, fever for 16 hours",Opioids,"['Dizziness', 'Heart rate increased', 'Pyrexia']",1,MODERNA,IM 921382,PA,48.0,F,"Headaches; Muscle pain; Low-grade fever; Body aches; Hot flashes; This is a spontaneous report from a contactable Nurse (patient herself). This 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via intramuscular, on 20Dec2020 at 18:15 at single dose for COVID-19 immunisation. Vaccine location was Arm Right. The patient was not pregnant. Relevant medical history included elevated rheumatoid factor, restless leg syndrome and depression. Past drug history included allergy to ferrous gluconate. Relevant concomitant medications included pramipexole dihydrochloride (MIRAPEX). The patient was vaccinated at hospital, age at vaccination was 48-year-old. No other vaccine was received in four weeks. Pre-vaccination COVID test was not performed. Post-vaccination COVID tests were performed: nasal swab on 28Dec2020 was negative; PCR in Dec2020 was negative. On 21Dec2020 at 18:30, the patient had headaches, muscle pain, body aches, low-grade fever and frequent hot flashes throughout the day at random moments, along with headaches and bod. The patient was not treated for the events. The patient had not recovered from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/21/2020,1.0,PVT,MIRAPEX,,Medical History/Concurrent Conditions: Depression; Restless leg syndrome; Rheumatoid factor increased,,,"['Body temperature', 'Headache', 'Hot flush', 'Myalgia', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 921383,TX,43.0,M,Extreme muscle soreness in whole body as well as injection site. Extreme shivering. Dizziness. Nausea. Severe headache. Severe coughing with some sputum.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,"Statin, Zettia, omega 3, fish oil",Covid 19,Hyperlipidemia,,NKDA,"['Chills', 'Cough', 'Dizziness', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Productive cough']",1,PFIZER\BIONTECH,IM 921384,,57.0,F,"Headache; Really really tired; Really really cold; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient herself). This 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685, Expiration Date Mar2021), via intramuscular, on 28Dec2020 at 13:30 at single dose for COVID-19 immunisation. Vaccine location was left arm. Age at vaccination was 57-year-old. Relevant medical history included anxiety and fibromyalgia. The patient was receiving concomitantly a drug (unspecified) at dose of 60 mg daily from Sep2020. This patient stated that she is not a healthcare professional but works in the diet area/kitchen of which is a hospital. On 29Dec2020 she felt really really tired, got really really cold, had chills, nausea. On 30Dec2020, in the morning, she had onset of headache. She still had a slight headache and a little nausea, but did not have the chills. She did not knowif this has anything to do with the vaccine but wanted to report the information. She did not plan to change her dose; she was scheduled to get the second dose on 15Jan2021 at 1:00pm which she still plans to get. The outcome of 'really really fatigue' and 'really really cold' was unknown; the event 'chills' recovered in Dec2020; the outcome of 'nausea' and 'headache' was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,UNK,,,Medical History/Concurrent Conditions: Anxiety (Anxiety and to help with Fibromyalgia); Fibromyalgia (Anxiety and to help with Fibromyalgia),,,"['Chills', 'Fatigue', 'Headache', 'Nasopharyngitis', 'Nausea']",1,PFIZER\BIONTECH,OT 921385,NC,51.0,F,"Mild headache within first hour relieved some with Tylenol. 12 hours after injection, awoke to severe headache, and nausea; Mild headache within first hour relieved some with Tylenol. 12 hours after injection, awoke to severe headache, and nausea; This is a spontaneous report from a contactable nurse (patient herself). This 51-year-old female nurse received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 28Dec2020 at 16:00 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was not pregnant. Relevant medical history included type 2 diabetes. No known allergies. Relevant concomitant medications included metformin, pravastatin and paracetamol (TYLENOL). The patient was vaccinated at hospital, age at vaccination was 51-year-old. No other vaccine was received in four weeks. Post-vaccination COVID test was not performed On 28Dec2020 at 17:00, the patient had mild headache within first hour relieved some with paracetamol (TYLENOL). 12 hours after injection, awoke to severe headache, and nausea. Unrelieved with TYLENOL after one hour. She took ibuprofen, 'CLARITIN' and ondansetron hydrochloride (ZOFRAN). Eventually relieved 1.5 hr after that. The patient recovered from both events in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,; ; TYLENOL,,Medical History/Concurrent Conditions: Type 2 diabetes mellitus,,,"['Headache', 'Nausea']",1,PFIZER\BIONTECH, 921386,ME,33.0,M,"Patient was vaccinated in upper left arm with COVID Moderna vaccine on 12/30/20 at around 4:25 p.m. Around 5:00 p.m. patient developed tingling feeling in left side of face which lasted remainder of day. Patient took Benadryl which seemed to help symptoms. On 12/31/20 left side of face had slight swelling which went away over course of day. Tingling has continued on and off since 12/30/20 and at times has manifested as mild jaw or muscle pain on left side of face. No diminished function in eye, mouth, and no paralysis or sagging in facial features.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,"Singular, Bupropion, Pantoprazole, Lisinopril",None,None,,"Sulfa Drugs, Penicillin","['Myalgia', 'Pain in jaw', 'Paraesthesia', 'Swelling face']",1,MODERNA, 921387,,43.0,F,"positive for covid; positive for covid; positive for covid; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. completely excluded. More information such as laboratory findings on nucleic acid /PCR test needed for meaningful medical assessment.The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID on 20Dec2020. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. More information such as virus genome /nucleic acid detection needed for meaningful medical assessment",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/20/2020,2.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 921388,,,U,"Painful arm; This is a spontaneous report from contactable nurse (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 28Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported to have received the Pfizer Covid vaccine yesterday (28Dec2020). The patient experienced painful arm even on the second day. The outcome of event was not recovered. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,UNK,,,,,,['Vaccination site pain'],UNK,PFIZER\BIONTECH, 921389,SC,38.0,F,5 minutes after receiving vaccine: Itchy throat Mouth numb Runny nose 30 minutes Eyes watering Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/05/2021,4.0,PVT,None,None,None,,None,"['Headache', 'Hypoaesthesia oral', 'Lacrimation increased', 'Rhinorrhoea', 'Throat irritation']",2,PFIZER\BIONTECH,IM 921390,CA,43.0,F,"Arm pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the right arm on 30Dec2020 at 08:00 (at the age of 43-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 30Dec2020 at 13:30, the patient experienced arm pain. No treatment was provided for the event arm pain. The outcome of the event arm pain was unknown. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH,OT 921391,MI,59.0,M,"Itching; Little bit nervous; This is a spontaneous report from a contactable consumer reporting for himself. A 59-year-old male patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced itching and little bit nervous on an unspecified date with outcome of unknown. The information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Nervousness', 'Pruritus']",UNK,PFIZER\BIONTECH, 921393,,,U,"Don't feel good at all; Feel like chills and the temperature; Feel like chills and the temperature; Not feeling myself today; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. In Dec2020 after vaccination, patient didn't feel good at all, the patient just feel like chills and the temperature and the patient was not feeling myself. The outcome of the events was unknown. Information on lot number/Batch number was requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/01/2020,,UNK,,,,,,"['Body temperature', 'Body temperature abnormal', 'Chills', 'Feeling abnormal', 'Malaise']",UNK,PFIZER\BIONTECH, 921394,IL,38.0,F,"sweating; Fatigue; Fever; Headache; chills; This is a spontaneous report from a contactable consumer. A 38-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number: EL1284, via an unspecified route of administration, in the left arm, on 29Dec2020 at around 17:15 (at the age of 38 years-old) as a single dose for COVID-19 immunization. Medical history included ongoing high blood pressure, diagnosed about 15 years ago. There were no concomitant medications. It was not known if the patient received any other vaccines within four weeks prior to the vaccination. On 30Dec2020, the patient experienced fatigue, fever, chills, headache and sweating. The clinical course was as follows: The patient reported that she started developing symptoms after having the COVID vaccine on 29Dec2020. On 30Dec2020, she was fatigued. The headache started earlier in the day. She did not have a thermometer on hand but she thought she had a fever and chills. She was wrapped up because she was so cold. She took 600mg of Ibuprofen around 13:30, which she thought broke her fever because she was sweating. She was still fatigued but not as bad as when she had a fever. The clinical outcome of the fever and chills was recovered, for the fatigue was recovering; the headache was not recovered; the outcome of the sweating was not reported. It was not known if she was tested for COVID-19 after the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,UNK,,Blood pressure high (Was diagnosed with this about 15 years ago.),,,,"['Blood pressure measurement', 'Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Pyrexia']",UNK,PFIZER\BIONTECH, 921395,MN,,F,"Extreme exhaustion; Headache; My arm was sore; This is a spontaneous report from a Pfizer Sponsored Program. A contactable healthcare professional (HCP, patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 29Dec2020, the patient experienced extreme exhaustion, headache, her arm was sore. No symptoms at all till 72 hours after the vaccine. The outcome of events was unknown. Information on Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/29/2020,3.0,UNK,,,,,,"['Fatigue', 'Headache', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 921396,NE,,F,"Flu like symptoms, chills and body aches with A 100.2 temp.. last 12/31-1/1",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,various prescriptions,no,no,,"latex, peneciline, sulfa, azithromycin, bee stings","['Body temperature increased', 'Chills', 'Influenza like illness', 'Pain']",1,MODERNA,SYR 921397,,,F,"she started to feel ""pick, pick, pick"" starting in the ears; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age (Age: 67; Units: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 30Dec2020 16:20 to 30Dec2020 16:20 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported she received the vaccine on 30Dec2020 16:20 and four hours post administration she started to feel 'pick, pick, pick' starting in the ears. The outcome of the event was unknown. Information about Lot/batch no has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,UNK,,,,,,['Hypoacusis'],UNK,PFIZER\BIONTECH, 921398,,,F,"Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; This is a spontaneous report from a contactable nurse (patient). A female patient of unspecified age started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), unspecified route of administration on 28Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Dec2020, the patient experienced feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm, Had same feeling the next day but better compared to the day before. In addition, the nurse reported she woke up to breastfeed. Outcome of the events feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm were recovering. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/01/2020,,UNK,,,,,,"['Abdominal pain', 'Chills', 'Diarrhoea', 'Malaise', 'Nausea', 'Rash', 'Throat tightness']",UNK,PFIZER\BIONTECH, 921399,IA,45.0,F,"Local site reaction- raised red, itchy area approximately 2 inches high by 4 inches wide at site of injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/31/2020,5.0,PVT,nuvaring,none,none,,sulfa medications OptiFree contact lens solution some band aids various/general fabrics- skin sensitivity,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Local reaction']",1,MODERNA,IM 921400,,,F,"fever, chills, headache, etc.; fever, chills, headache, etc.; fever, chills, headache, etc.; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of unspecified age started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), unspecified route of administration on 30Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Dec2020, the patient experienced fever, chills, headache, etc. The reporter inquired is it ok to take ibuprofen (MOTRIN) Motrin or acetaminophen (TYLENOL). Outcome of the events fever, chills and headache were unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/01/2020,,UNK,,,,,,"['Chills', 'Headache', 'Pyrexia']",UNK,PFIZER\BIONTECH, 921401,NM,70.0,F,"Persistent headache/ felt very sick with headache on and off; I had body ache; Nausea; Dizzy; I was feeling very weird/ felt awful; my arm hurt; This is a spontaneous report from a contactable nurse reporting for herself. A 70-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899 (as reported: ""don't know if it E or and F, looks like EH9899"") & Expiry Mar2021, via an unspecified route of administration on 22Dec2020 as a single dose (age at vaccination 70 years old), for COVID-19 immunization. Medical history included pulmonary hypertension. The patient's concomitant medications were not reported. The patient had a persistent headache that doesn't go away, and had body ache (onset 23Dec2020). She reported feeling ""like I had COVID."" She went and got tested because she was a healthcare worker; her first test was negative (Dec2020) and her second test today (29Dec2020) was negative. She thought because it all started the day after vaccine (23Dec2020), that day she felt very sick with headache on and off, nausea, and was dizzy. She was feeling very weird and her arm hurt and she knew that she was going to have some side effect, so she went to work and took some ibuprofen (MOTRIN) for the pain and that was it. She took the vaccine on Tuesday, Wednesday she felt awful, Thursday, the only thing she had was pain in arm that's it but Friday started again with headache and all these symptoms that haven't gone away. The clinical outcome of the event persistent headache, body ache, nausea, dizzy, feeling very weird/ awful was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,UNK,,,Medical History/Concurrent Conditions: Pulmonary hypertension,,,"['Dizziness', 'Feeling abnormal', 'Headache', 'Myalgia', 'Nausea', 'Pain in extremity', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 921402,OK,27.0,F,"Headache after shot was administered. At 0400 began having chills, body aches, redness and itching around injection site, nausea, sore throat, ear ache. Took Excedrin migraine. Symptoms have resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,SEN,None,No,None,,NKA,"['Chills', 'Ear pain', 'Headache', 'Injection site erythema', 'Injection site pruritus', 'Nausea', 'Oropharyngeal pain', 'Pain']",1,MODERNA,IM 921403,,,M,"Covid like symptoms; fever; muscle aches; This is a spontaneous report from a contactable Nurse. A 58-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient medical history included positive for COVID in Sep2020. He was positive 98 days before receiving the vaccine. Concomitant medications were not reported. The patient experienced covid like symptoms which include fever and muscle aches on Dec2020. Patient would like to know if receiving the vaccine after having COVID in September was causing his symptoms; if his symptoms are expected or common after the first dose; and if he should receive the second dose. Event outcome was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: COVID-19 virus test positive,,,"['Myalgia', 'Pyrexia', 'SARS-CoV-2 test', 'Suspected COVID-19']",UNK,PFIZER\BIONTECH, 921404,SC,57.0,F,"injection site pain, swelling, and redness; injection site pain, swelling, and redness; injection site pain, swelling, and redness; This is a spontaneous report from a contactable consumer (patient). A 57 year old female consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot Number/Expiration date: not provided), via an unspecified route of administration, on 28Dec2020 (at the age of 57 years old), at the hospital she works out of, as a single dose in the left arm for COVID-19 immunization. Relevant medical history included penicillin allergy. Concomitant medication was not provided. The consumer reported that she has taken no new medications, and did not receive any other vaccines when she got this one. On the same day, on 28Dec2020, the consumer experienced injection site pain, swelling, and redness. The consumer described the injection site swelling, and redness as a big bullseye, it is a raised knot, and the whole area is red. The consumer reported that she used a tape measure to measure it, and it was only 2 inches by 2.5 inches. The consumer reported that the redness, swelling, and pain she has does not interfere with her day other than she is sore and it is big. Treatment received for the events included icing it off and on. The outcome of the events injection site pain, swelling, and redness was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy (Verbatim: Penicillin allergy),,,"['Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 921405,,,U,"sore arm; a bit of a headache; an uncontrollable urge to happy dance; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable consumer (patient). A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Twenty-four hours later in Dec2020, the patient got a sore arm, a bit of a headache, and an uncontrollable urge to happy dance, but otherwise feeling pretty unchanged. Outcome was unknown. Information about lot/batch number cannot be obtained. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Euphoric mood', 'Headache', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 921406,GA,32.0,F,"Temp 102.0, muscle and joint pain, coughing, headache Tested positive for COVID on 1/2/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,UNK,,,,,,"['Arthralgia', 'Body temperature increased', 'COVID-19', 'Cough', 'Headache', 'Myalgia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 921408,AZ,,F,"Body ache and headache; Body ache and headache; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced body ache and headache (non-serious) on 31Dec2020. She has no fever. The patient asked, ""I'm concerned about my side effects. Should I get tested for COVID-19?"" The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/31/2020,2.0,UNK,,,,,,"['Headache', 'Pain']",UNK,PFIZER\BIONTECH, 921409,NC,67.0,U,"I have 99 fever; My arm is sore; Cold; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/lot number, NDC and UPC number and expiry Date: unknown), via an unspecified route of administration in Dec2020 (at the age of 67-year-old) as a single dose for COVID-19 vaccination. The patient had no relevant medical history. The patient's concomitant medications were not reported. In Dec2020, the patient woke up with a 99 fever that went to 98.4, arm was sore and didn't know if it was a cold. The patient was treated with ibuprofen for sore arm. The clinical outcome of 99 fever, arm was sore and cold was unknown. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Body temperature', 'Nasopharyngitis', 'Pyrexia']",UNK,PFIZER\BIONTECH, 921411,FL,36.0,F,"Vommiting, Body aches, Fever of 102; Vommiting, Body aches, Fever of 102; Vommiting, Body aches, Fever of 102; This is a spontaneous report from a contactable other healthcare professional, the patient. A 36 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown), via intramuscular route of administration in the left arm on 28Dec2020 at 08:00 AM (at the age of 36-years-old) as a single dose for COVID-19 vaccination. The patient had no relevant medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 28Dec2020, the patient experienced vomiting, body aches and fever of 102. The report was reported as non-serious. The patient was not treated for vomiting, body aches and fever of 102. The clinical outcome of vomiting, body aches and fever of 102 was recovered on an unknown date. It was also reported that since the vaccination, the patient had been tested for COVID-19 (rapid test nasal swab) on 31Dec2020 and was negative. No follow-up attempts are possible, information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting']",1,PFIZER\BIONTECH,OT 921412,MN,73.0,U,"little bit of soreness in my arm; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Dec2020 (at the age of 73-years-old) as a single dose for COVID-19 vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated ""I just got my shot yesterday and I'm 73 and I was sure that I was gonna have something but I got absolutely nothing. A little bit of soreness in my arm but I can live with that."" The clinical outcome of soreness in arm, was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/01/2020,,UNK,,,,,,['Pain in extremity'],UNK,PFIZER\BIONTECH, 921414,,,F,"neck and shoulder pain; neck and shoulder pain; This is a spontaneous report from a contactable nurse via Medical information team. A female patient of an unspecified age (Age: 42 Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose on Monday and experienced neck and shoulder pain on unspecified date. The patient has been seen at Employee Health but indicated that the effect appeared to be worsening. The patient was transferred to receive indication of whether to receive second dose and if this was a serious adverse event. The outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Arthralgia', 'Neck pain']",UNK,PFIZER\BIONTECH, 921415,,,F,"injection site pain; sore throat; cough; mild headache; muscle pain; This is a spontaneous report from a contactable other healthcare professional. A female patient of an unspecified age (Age: 54: unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 18Dec2020 to 18Dec2020 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reported explained that the patient received the COVID-19 vaccine on 18Dec2020, after which she experienced: "" injection site pain, sore throat, cough, very mild headache and muscle pain"". She then asked if her symptoms were part of the commonly reported side effects, and if she should take a COVID test. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/01/2020,,UNK,,,,,,"['Cough', 'Headache', 'Injection site pain', 'Myalgia', 'Oropharyngeal pain']",UNK,PFIZER\BIONTECH, 921416,MA,,F,"Swelling arm/ swelling down to their biceps after receiving the COVID-19 Vaccine; arm soreness/ soreness in their arms after receiving the COVID-19 Vaccine; light redness around the vaccine injection site; body felt cold; felt real tired right after; fell asleep quickly; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 13:00 at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported the patient got the COVID-19 Vaccine at the same time as her husband did, and she had some symptoms afterwards, but her symptoms went right away. It was reported both she and her husband had soreness in their arms after receiving the COVID-19 Vaccine. She said a micro needle was used when the COVID-19 Vaccine was administered to both her and her husband's left upper arms. It was also reported both her and her husband had swelling down to their biceps after receiving the COVID-19 Vaccine. She said the swelling went away on both of their left arms after 12-14 hours. It was also reported the husband and his wife continuously monitored each others vaccine injection sites. She said the husband used a LED light to look at her left upper arm, and saw a light redness around her vaccine injection site. The husband said the light redness around the vaccine injection site went away in 2 hours after receiving the COVID-19 Vaccine. It was reported her body felt cold after receiving the COVID-19 Vaccine on 28Dec2020, and that she felt real tired right after she noticed her body felt cold. The husband said his wife fell asleep quickly on 28Dec2020, which is not normal for her, and slept for awhile. The husband said after she woke up she was fine. It was reported their arm swelling and soreness didn't really effect either one of them right away. He said the vaccine injection site redness for his wife started about 45minutes to an hour after she received the COVID-19 Vaccine. He said they both started to feel the soreness in their left arms later. He said he could feel the soreness at the vaccine injection site when he moved his left arm. He said it was the same for his wife when she moved her left arm, clarifying it was a very subtle feeling of soreness. The outcome of the events was recovered. Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Fatigue', 'Feeling cold', 'Injection site erythema', 'Injection site swelling', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 921419,,,F,"Allergic reaction; It affected her breathing and heart rate/shortness of breath; It affected her breathing and heart rate/shortness of breath; This is a spontaneous report from a contactable nurse. A 30-year-old female patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 30Dec2020 for immunization. The patient's medical history and concomitant medications were not reported. Patient received the vaccine on 30Dec2020 (day before reporting) at her place of work and about 12 hours after she received it during the night, she had an allergic reaction. Nurse thought it's an allergic reaction versus side effects because it affected her breathing and heart rate. They called 911 and it came in waves and they didn't go to hospital. She was better the day of reporting, although she was still having some waves of the shortness of breath and the nurse gave her one 25 mg (diphenhydramine (BENADRYL). Nurse asked do if company had a plan for allergic reaction after the vaccine to avoid having to go to the hospital. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,UNK,,,,,,"['Dyspnoea', 'Heart rate', 'Heart rate abnormal', 'Hypersensitivity']",UNK,PFIZER\BIONTECH, 921420,,,U,"more site reaction pain with Pfizer vaccine than modern vaccine; This is a spontaneous report from a non-contactable consumer via Pfizer Sales Representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on an unknown date at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, it was reported that the patient experienced more site reaction pain with Pfizer vaccine than Modern vaccine. Outcome of the event was unknown. No follow-up attempts are possible; Information about batch/lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination site pain'],UNK,PFIZER\BIONTECH, 921421,MA,58.0,F,"Employee received COVID-19 vaccine on 12/28/20. Reports doing well until this morning. Woke up feeling itchy around injection site (left upper arm). Reports area feels tender and with mild burning to touch. Arm is sore at injection site but able to perform daily normal activities. RN observed a red, raised, localized rash to left upper arm. Rash extends about 10 centimeters below injection site. Rash is localized and no other concerns at this time. RN advised to avoid touching or scratching the area. Cold compresses and OTC cortisone cream if it gets itchy again. Instructed to monitor and report any new or worsening symptoms. Instructed to seek immediate medical care if any hives or breathing issues develop. Patient voiced understanding and agreement with plan.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,,,,,,"['Burning sensation', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Tenderness']",1,MODERNA,IM 921422,,,F,"feels tingling and coldness in her fingers and feet; feels tingling and coldness in her fingers and feet; This is a spontaneous report from a contactable nurse (patient). This female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Caller stated that she started experiencing paresthesia a few hours after getting the vaccine. Mentioned that she feels tingling and coldness in her fingers and feet and wanted to know if this is normal or should be of concern. Caller wanted to know more information regarding patients who experienced paresthesia so she can provide information to her HCP to help them decide whether she can get next dose or not. Outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Paraesthesia', 'Peripheral coldness']",1,PFIZER\BIONTECH, 921425,TX,66.0,M,Noticed 4 days after vaccine that he was chewing his tongue and clitching his teeth. This lasted for 4 nights then stopped. He did a night guard due to this.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/22/2020,4.0,PVT,unknown,unknown,unknown,,unknown,"['Bruxism', 'Dermatophagia']",1,PFIZER\BIONTECH,IM 921426,GA,58.0,M,"blurred vision, elevated BP Went to PCP. Given BP med and advised not to take second dose of vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,UNK,,,,,,"['Blood pressure increased', 'Vision blurred']",1,MODERNA,IM 921427,CO,48.0,F,30 minutes after receiving the vaccine I had developed a welt and itchiness on an ear. About 45 minutes to 1 hour after the receiving the vaccine I developed some additional spots on my face and my throat felt like something was stuck in it. I purchased some oral Benadryl from the Outpatient pharmacy took 50mg and in 30 minutes my symptoms were resolving.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,PVT,not avl to this reporter,not avl to this reporter,not avl to this reporter,,not avl to this reporter,"['Ear pruritus', 'Sensation of foreign body', 'Urticaria']",1,PFIZER\BIONTECH, 921428,CO,76.0,F,Five days after shot I ran a temp of 99.8 degrees for four hours with aches in my neck and shoulders.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/03/2021,5.0,PVT,"Valsartan, amLODIPine. Zyrtec, crestor",None,Cancer last two years,,None,"['Arthralgia', 'Body temperature increased', 'Neck pain']",UNK,MODERNA,IM 921429,KS,56.0,M,Rash to upper chest and bilateral upper arms,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,OTH,"Alendronate, Carbamazepine, Cerovite jr., Depakote, Docusate Sodium, Folic Acid, Glycopyrrolate, Keppra, Lactulose, Losartan, Oyst-Cal-D, Vitamin C, Miralax",None,"Mental Retardation, Seizure Disorder, Microcephanly, Right sided hemiparesis, myopia, poor motor coordination, urinary incontinence, chronic constipation, osteoporosis, vasospastic foot.",,None,['Rash'],1,PFIZER\BIONTECH, 921432,WI,52.0,F,Couple Hours after getting covid 19 vaccination my arm hurt and got red warm and sore used tylenol and benedryl and still hurts after 5 days,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,SEN,Prenatal vitamin,no,no,,no,"['Pain in extremity', 'Skin warm']",1,MODERNA,IM 921433,OK,27.0,F,"Headache after vaccine administered. Around 0400 that morning complaints of chills, nausea, body aches, sore throat, ear ache, soreness and redness at injection site. Took Excedrin Migraine. Symptoms have resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,SEN,None,No,NO,,NKA,"['Chills', 'Ear pain', 'Headache', 'Injection site erythema', 'Injection site pain', 'Nausea', 'Oropharyngeal pain', 'Pain']",1,MODERNA,IM 921434,MI,29.0,F,Numbness and tingling around mouth,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,None Known,None Known,None Known,,None Known,"['Hypoaesthesia oral', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 921435,NV,47.0,M,At 1347 the recipient complained of a headache and dizziness. At around 1400 the recipient stated he felt better and left the site.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/17/2020,0.0,PVT,Unknown,unknown,unknown,,None,"['Dizziness', 'Headache']",1,PFIZER\BIONTECH,IM 921436,WA,57.0,M,"I experienced in 24 hours to 48 hours, i got muscle pain and joint pain. It then started to become pretty significant and got nauseous. The injection site got quite red about the second day of the reaction. the muscle pain and joint pain was getting worse. I got to take NSAID's, Toradol injection 30mg IM which worked quite well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,PVT,"Levothyroxine 150mcg OD, Benazopril 10mg BID, Prevastatin 40mg OD, Aspirin 325mg, OD",None,"High blood pressure, hypercholestryma, stroke (7-8 years ago), Haschinmoto thyroiditis (low thyroid)",,"Sulfa antibiotics (Bactrum), Levoquine (Class 4)","['Arthralgia', 'Injection site erythema', 'Myalgia', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,IM 921437,,30.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Ferrous Sulfate 325mg Montelukast 10mg,,,,"Banana avocados Beta Adrenergic blockers Prazosin Sertraline Environmental: trees, ragweed, dust mite, cat",['Headache'],1,MODERNA,IM 921439,MD,50.0,F,"day of vaccine: dull headache for the majority of the day (I don't typically get headaches) 2 days after vaccine: minor bilateral rash on face - both cheeks red, slightly raised bumps, no itching or pain, lasted for about 24-36 hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,PVT,enalapril 20 mg levothyroxine 100 mcg Zyrtec multivitamin Vit D Vit E,none,hypertension hypothyroid obesity,,dust,"['Erythema', 'Headache', 'Rash', 'Swelling face']",1,PFIZER\BIONTECH,IM 921440,NE,49.0,F,Had the shot at 8:30 a.m. At 12:00 pm felt out of breath and heart rate of 170 after climbing 1 flight of stairs. Sitting quietly for 30 min brought HR down to 100-110 but no lower. HR did not return to normal until 4:00 pm. Noted increase in heart palpitations in the evening of the day of the shot. These palpitations have occurred frequently while in a resting state every day since (now on day 6).,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,Depo Provera injection,None,None,,None,"['Dyspnoea', 'Heart rate increased', 'Palpitations']",1,MODERNA,IM 921441,NY,38.0,F,"I became COVID positive six days after vaccination, according to a BinaxNow rapid test.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,UNK,"Humira, Nexium","What appeared to be a common cold, cleared up approximately two weeks before vaccination.",Rheumatoid arthritis,,"Bee and wasp stings, other unknown allergy which recently caused severe hives. Appeared to be food related but direct cause unknown currently.","['COVID-19', 'SARS-CoV-2 test positive']",1,MODERNA,SYR 921442,IA,31.0,M,"body aches, chills, headache, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PUB,,,,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 921443,CA,39.0,F,"Tongue and throat swelling, followed by dizziness and slight itchiness. Was monitored by RN and symptoms subsided after about 30 minutes with no treatment. Vital signs were normal. Blood glucose check was normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,no,,,,Food - Kiwi,"['Dizziness', 'Pharyngeal swelling', 'Pruritus', 'Swollen tongue']",1,MODERNA,IM 921444,WA,28.0,M,Erythema Multiforme minor (painful target lesions on palms and soles of feet),Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/26/2020,3.0,MIL,,No other illnesses,,,,"['Erythema multiforme', 'Target skin lesion']",UNK,MODERNA,IM 921445,MN,30.0,M,Palpitations the first night Hyperactivity the next day; trouble with concentration Brain fog for several days after 12/30/2020; brain fog still continuing; trouble concentrating; not as apt with mental tasks as previously,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,None,None,None,,Iodine,"['Disturbance in attention', 'Feeling abnormal', 'Palpitations', 'Psychomotor hyperactivity']",1,MODERNA,IM 921446,PA,52.0,F,"Approximately 10 minutes after vaccine administration, patient developed chest pain, skin cool and clammy. Felt like heart racing. Dizzy. Radial pulse 88 and regular. BP 116/72. Patient declined going to the Emergency Department and was observed for approximately another 30 min, Chest discomfort subsided. Her husband ( an MD) came in and took her to his office for further observation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,UNKNOWN,UNKNOWN,UNKNOWN,,NONE LISTED,"['Chest pain', 'Cold sweat', 'Dizziness', 'Palpitations']",1,PFIZER\BIONTECH,IM 921447,OH,47.0,F,Swollen lymph node sub-clavicle on left side. Notice on 1/04/2021 around 8:00 PM. Lymph node continued to get bigger through the night and is sore to touch,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,PVT,"Vitamin D3 50,000 once a week",none,none,"Varicella vaccine. 43 years of age. August of 2016. manufacter unknown. 28 days post vaccine, developed full chicken pox",codiene egg sensitivity,"['Hyperaesthesia', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 921449,NJ,36.0,F,"Large rash developed over injection site approx 7 days after receiving the injection. Initially was a hard lump that was red and warm, approx the size of a golf ball. The recess spread over the next 2 days to approx the size of a softball",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,PVT,Mirena,cough- tested negative for COVID on 12/17/20,none,,no known allergies,"['Injection site erythema', 'Injection site induration', 'Injection site rash', 'Injection site swelling']",1,MODERNA,IM 921450,TX,54.0,F,"About 1 minute after receiving vaccination, lips were numb (like receiving local dental anesthesia) and felt fat. Initial BP 140/89 HR 100 @10:00am. BP 193/93 HR 133 @10:15am. Numbness and tingling resolved by 10:15am. BP 163/79 HR 85 O2 98% @10:35am. Patient clinically stable. Patient released at 10:35am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Humira, prednisolone eyedrops, Combigan eyedrops, Vit D, zinc",None,"VKH, panuveitis",,"penicillin (tachycardia), pork (throat closing)","['Dizziness', 'Hypoaesthesia oral', 'Immediate post-injection reaction', 'Paraesthesia']",1,MODERNA,IM 921451,WI,34.0,F,"Nausea, mild dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Dizziness', 'Nausea']",UNK,MODERNA,IM 921452,IA,46.0,F,"diarrhea, stomach upset, body aches, chills, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,,,,,,"['Abdominal discomfort', 'Chills', 'Diarrhoea', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 921453,CA,31.0,F,numbness of the throat and back of the tongue,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/23/2020,0.0,UNK,,,,,,"['Hypoaesthesia oral', 'Pharyngeal hypoaesthesia']",1,PFIZER\BIONTECH,SYR 921454,TX,69.0,F,"Approximately 25 minutes after receiving vaccine, patient experienced tenderness below the left clavicle (felt like a bad bruise). BP 142/77 HR 69. Tenderness subsiding approximately 20 minutes later. BP 135/74 HR 59. Patient clinically stable. Patient released at 10:45am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"levothyroxine, Zyrtec, MVI, fish oil, Asmanex IH, Z-pak","acute, bronchitis","hyperthyroidism followed by hypothyrodism (thyroidectomy), asthma",,"Penicillin (hives), Codeine (flushed/tingling/SOB)","['Contusion', 'Musculoskeletal chest pain']",1,MODERNA,IM 921456,AZ,24.0,F,"Swelling and rash was noticed on morning of 12/29/20, a day after injection was given, on injection site. There was alot of pain to site and some itching late the same day. Went to urgent care to have arm looked at since rash looked bigger on 12/30/20. PA took a look and diagnosed me with ""cellulitis of left upper limb"" and ""adverse effect of other viral vaccine, initial encounter"". She prescribed Keflex 500mg and Cetirizine 10mg treating it as an infection. Redness went away on 1/3/21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PUB,,,,,No known allergies,"['Cellulitis', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Vaccination complication']",1,MODERNA,IM 921457,ME,47.0,F,"swelling, redness, warmth and tenderness of upper arm extending from injection site around outer upper arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/26/2020,3.0,PVT,"Claritin, Metoprolol, Sprinolactone",none,none,,"Ambien, Compazine","['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA,IM 921458,OH,51.0,M,Headache Nauseous Joint pain Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/03/2021,2.0,PHM,Norvasc,,Hypertension,,Phenergan Compazine,"['Arthralgia', 'Headache', 'Laboratory test', 'Nausea', 'Pyrexia']",1,MODERNA,IM 921459,CO,53.0,M,"Diffuse Rash, itching all over, neck, arms, abdomen, thighs, low back predominantly. Tried to find other cause, but could not. Started within 5 days of vaccine. Now fading wish use of hydrocortisone cream/lotion.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/29/2020,5.0,WRK,"Tramadol, cymbalta, Losartan, centrum silver mvi, asa, all?s seltzer cold, arginine, zinc, magnesium",None,"Hypertension, chronic pain (injuries, post 7 surgeries) chronic duodenitis,",,"NKA/NKFA, seasonal pollen/weed allergies","['Pruritus', 'Rash']",1,MODERNA,IM 921460,WA,54.0,F,"Tingling sensations and felt ""off"" like ""out of body"".",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,,,,,,"['Autoscopy', 'Feeling abnormal', 'Paraesthesia']",UNK,MODERNA, 921461,TX,41.0,F,"I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on the 25th of December, then I started having symptoms at 3:30 am on December 29th I went and got tested that morning and the test was positive for covid-19. I then went home to quarantine. I have experienced fever, body aches, headaches, nausea, diarrhea, sinus pressure, chills, loss of taste and smell, weakness and fatigue. But have been able to continue to recover at home.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/29/2020,6.0,OTH,"Bystolic, Benicar, Wellbutrin",none known,HTN,,none known,"['Ageusia', 'Anosmia', 'Asthenia', 'COVID-19', 'Chills', 'Diarrhoea', 'Exposure to SARS-CoV-2', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Paranasal sinus discomfort', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 921462,NY,57.0,F,"48hr Headache which evolved into a migraine with vomiting,lethargy and pain at injection site 12 hour after the injection, fever 99.1",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Headache', 'Injection site pain', 'Lethargy', 'Migraine', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 921463,MA,40.0,F,"The 23rd within the first hour my arm had gone numb, I do have the similar reaction with the flu vaccine. Within the first hour I felt dizzy and I was going to pass out and nausea. I completed the rest of my shift, not sure how I did it. I woke up in the middle of the night with a head ache and not feeling well. On the 24th I started sweating and dry heaving very bad and had no temp. I was in and out of the bathroom the entire shift. The next day (25th)I woke up and thought I had the flu, my lymph nodes in my throat had swollen and I just felt bad the entire day. The fatigue and exhaustion was un believable. By the 28th I started to feel much better. Then everything returned back to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,Vitamins Macrobid Symbicort inhaler,,Cardiac Issues Asthma,,Lactose Duriceff Imatrex prevacit Latex,"['Dizziness', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Hypoaesthesia', 'Lymphadenopathy', 'Malaise', 'Nausea', 'Presyncope', 'Retching']",1,MODERNA,SYR 921464,CA,42.0,F,"Headache started 20 minutes after vaccine was administered Left arm feels very heavy, weak started 40 minutes after vaccine was administered",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,buPROPion (XL) 150 mg 24 hr tablet lisinopril 10 mg tablet NIFEdipine 90 MG 24 hr tablet FLUoxetine 40 mg capsule,,"HTN (hypertension) Moderate recurrent major depression (HCC) Localized swelling, mass and lump, upper limb Hyperhidrosis",,,"['Asthenia', 'Headache', 'Limb discomfort']",1,PFIZER\BIONTECH,IM 921465,RI,51.0,F,"51-year-old female with history of intermittent asthma presented to the ED with 1 week of intermittent fevers, myalgias, arthralgias and headache. Patient reports receiving first dose of moderna vaccine last week. She initially developed arm soreness followed by chills and body aches. Subsequently developed frontal headache, photophobia, back pain, nausea and vomiting. She was seen in the ER on 1/1/21, when her work-up including labs, CT spine, chest x-ray were negative therefore she was discharged home. She continued to have symptoms and also developed bilateral intermittent ear pain. She also developed rash in her extremities and torso. Rash is pruritic but not painful. reports ongoing history of neck pain for which she sees PT. Denies sore throat, cough, chest pain or shortness of breath.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/27/2020,12/30/2020,3.0,PVT,,,,,,"['Arthralgia', 'Back pain', 'Chest X-ray normal', 'Chills', 'Computerised tomogram normal', 'Computerised tomogram spine', 'Ear pain', 'Headache', 'Laboratory test', 'Myalgia', 'Nausea', 'Pain', 'Pain in extremity', 'Photophobia', 'Purpura', 'Pyrexia', 'Rash', 'Vomiting']",UNK,MODERNA,IM 921466,IA,37.0,F,"fever, vomiting, headache, dizziness, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PUB,,,,,,"['Dizziness', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",UNK,MODERNA,IM 921467,OH,43.0,F,"Exactly 1 week after receiving dose, my left arm became swollen and itchy about 2 inches below the vaccine site. The area affected was about 3 in x 1 in. The redness and swelling proceeded to get larger over the next 24 hours, and now is about 5 in x 6 in. I have started oral doses of Benadryl. Today, my throat is a little sore and feels swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,"Vitamin D 50,000IU per week",none,sleep apnea,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Oropharyngeal pain', 'Pharyngeal swelling']",1,MODERNA,IM 921470,IL,25.0,M,"FEVER, CHILLS, HEADACHE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,NONE,NONE,NONE,,NONE,"['Chills', 'Headache', 'Pyrexia']",1,MODERNA,IM 921471,TN,24.0,F,Pt states approximately 45 minutes after vaccination that she developed a rash on her chest and her throat felt itchy. Pt called clinic and was advised by MD to take Benadryl and go immediately to the ER if she developed any SOB. Patient called at 1:30 PM and states after taking Benadryl her symptoms resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,Zoloft Buspar,None,None,,NKDA,"['Rash', 'Throat irritation']",1,MODERNA,IM 921472,IA,39.0,F,"low grade temp, headache, nausea, dizziness, muscle aches, joint pain, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PUB,,COVID19 December 7th.,,,,"['Arthralgia', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",UNK,MODERNA,IM 921473,NJ,34.0,F,Lightheaded and dizzy,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Epi-pen, dymista, Claritin, albuterol inhaler.",,Asthma,,Seasonal and percocet.,['Dizziness'],1,MODERNA,IM 921474,ID,37.0,F,"Right after the injection, there was a rush through my body ( like an epideral) and then my heart started pounding fast, I sat down for the 15 minutes and thought it would go away but it wouldn't and seemed to be getting faster, after 20 minutes ( 4:10ish) I waved a person over who worked in the clinic and they took my BP and pulse. The person took me to the ER in a wheelchair, since it was across the hall. They did an EKG on me, and evaluated me for an hour, and I was released once my pulse slowed down to 99 and I felt better. It has been 7 days and I have continued to have tachycardia while sitting, with my pulse going from the 70s to to 130s for no reason. It will come in episodes. I went and saw my primary care doctor today and my pulse was 105-115 sitting. I have cut out coffee since the incident on 12/29/2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,None,None,None,,None,"['Blood pressure decreased', 'Electrocardiogram', 'Immediate post-injection reaction', 'Palpitations', 'Tachycardia']",1,MODERNA,IM 921475,WY,65.0,M,Abdominal cramping and diarrhea pretty much beginning on day 2 post vaccination and has lasted for 10 days so far. OTC treatment with Imodium was used.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/25/2020,2.0,PVT,Tylenol and ibuprofen as needed.,None,None,,None,"['Abdominal pain', 'Diarrhoea']",1,PFIZER\BIONTECH,IM 921476,WI,34.0,F,"Pt c/o of feeling really hot mainly in her chest and a flushing feeling going her entire body, she said her heartrate was beating really fast. We used a pulse ox machine her O2 saturations were 100% the entire time, initially her heart rate was 139 and came down quickly to 80's....no difficulty breathing no dizziness some tingling sensation in both hands... monitoring patient longer than 30 mins. she stated she felt hot again after the initial event. t. For the last 20 minutes her HR was 80'2 oxygenation 100% no other complaints. Pt did a lunch prior to coming for vaccination. Pt drank a bottle of water with no complications. No difficulty swallowing or rash. at 1350 employee (the Pt) stated she felt the sensation again, pt escorted to the ER by VP of Nursing.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,omeprazole and fluoxetine,no,no,,nka,"['Chest discomfort', 'Feeling hot', 'Flushing', 'Heart rate increased', 'Paraesthesia']",1,MODERNA,IM 921477,OK,52.0,F,at 1014 c/o itchy mouth and lip; 1020 lips are better but throat was itchy; voice was gravely and had a cough non productive; given solumedrol 125 mg IVP; 1038 given xopenex HHN per protocol; Benadryl 25mg IVP; 1115 tightness gone voice clear and less cough,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Tamoxifen 20mg; losartan 100 mg daily; carvedilol 6.25mg bid; 2 vitamin C bid; 2 Calcium /magnesium bid,none,"Breast Cancer, Loeys-dietz; qualitative platelet disorder;",,Shellfish; water chestnuts; contrast;,"['Cough', 'Dysphonia', 'Lip pruritus', 'Oral pruritus', 'Throat irritation', 'Throat tightness']",1,MODERNA,IM 921478,ID,26.0,F,"Pt. reported feeling itchy all over her body approximately 1 hour after receiving Moderna Vaccine. Pt. was given oral Loratadine and Benadryl 50mg at approximately 12:05 and found relief with medications but also reported a tingling sensation on both sides of cheeks that extended to her lips. At approximately 1:30 pt. reported feeling heart palpitations, Dr. ordered an EKG - results were nornal. An IV was started at this time and pt. received . IV Bolus of LR 1 L was administered. Pt. was evaluated by Dr. and discharged home at approximately 4pm that same day. Pt. symptoms did not worsen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,None,None,,Sulfa,"['Electrocardiogram normal', 'Palpitations', 'Paraesthesia', 'Paraesthesia oral', 'Pruritus']",1,MODERNA,IM 921480,TN,38.0,F,"Approx. 15 min after dose 1 onset numbness/tingling sensations from bil elbow to hands, and bil knee to feet. Denied loss of sensation described as pins and needles. Seen in the Emergency Department and released: Received IV fluids and all labs were within normal limits.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,Breo cetirizine citalopram Albuterol MDI PRN,None,Asthma,,None,"['Bacterial test', 'Drug screen negative', 'Hypoaesthesia', 'Paraesthesia', 'Platelet count increased', 'Urine leukocyte esterase positive']",1,PFIZER\BIONTECH,IM 921481,OH,88.0,M,"Vaccine given on 12/29/20 by Pharmacy. On 1/1/21, resident became lethargic and sluggish and developed a rash on forearms. He was a Hospice recipient and doctor and Hospice ordered no treatment, just to continue to monitor. When no improvement of codition reported, doctor and Hospice ordered comfort meds (Morphine, Ativan, Levsin). Resident expired on 1/4/2021",Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,SEN,Vitamin D3 5000 units qd Furosemide 20mg qd Olanzapine 2.5mg bid,Dementia Chronic PVD,Dementia PVD,,No known allergies,"['Death', 'Lethargy', 'Rash', 'Sluggishness']",1,PFIZER\BIONTECH,IM 921482,MN,48.0,F,"Noticed itching on Left upper arm, thinking it was a bug bite, lifted up sleeve and realized it was the site of the vaccination; area was red 2X3 inches long, itches and warm to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,WRK,Vitamin D,NONE,NONe,,Sulfa Cipro,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 921483,WI,36.0,F,"Patient stated while showering the am of 1/4 noticed a red area over COVID vaccine injection site. As the day went on, she became itchy all over and developed a rash. Describes redness of injection site, pain in lymph nodes in armpit, diffuse itching",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,01/04/2021,9.0,WRK,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Lymph node pain', 'Pruritus']",1,MODERNA,IM 921484,TN,24.0,F,Pt states approximately 45 minutes after vaccination she developed a rash on her chest and itchy throat. Pt called clinic seeking advice. Dr. advised patient to take Benadryl and immediately proceed to ER if experiencing SOB. Pt states she took Benadryl and symptoms resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,Zoloft and Buspar,none,none,,none,"['Rash', 'Throat irritation']",1,MODERNA,IM 921485,PA,24.0,M,"I am reporting a strange bump underneath my collarbone, possible enlarged lymph node Reported bump is moveable, slightly firm, but not hard bump only appears on left side, underneath the collarbone, not found on the other side Bump is not painful, or tender Bump is roughly the size of a pinky",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,WRK,,,,,,['Swelling'],1,MODERNA,IM 921486,IA,44.0,F,Swelling and pain in axilla and along distal aspect of breast on injection side.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/03/2021,4.0,PVT,OTC famotidine,None,Vericose veins,,None,"['Axillary pain', 'Swelling']",1,MODERNA,IM 921487,CO,31.0,F,"Moderna COVID?19 Vaccine EUA 6 days after injection I had increased itching in the evening. Day 7 after first injection around 9 am, Ihad increased itching and observed redness around the lateral deltoid on the L side with increased swelling. I have no pain or tenderness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,Nexplanon birth control; multivitamin,None known,None known,,None known,"['Injection site erythema', 'Injection site swelling', 'Pruritus']",1,MODERNA,SYR 921488,PA,52.0,F,"FEVER(100.5), CHILLS, HEADACHE, NAUSEA, RAPID HEART BEAT, SWELLING @ INJECTION SITE, SHORTNESS OF BREATH; DRY MOUTH DRY EBEY FLUSHED, FATIGUED, FREQUENT BOWEL MOVEMENT 7 URINATION. COUGH",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"levothyroxine 75mcg, nifedipine ER 30mg,hydrochlorothiazide 12.5mg",none,"MVP, Graves Disease, Kidney Disease, , Mild Asthma ,Fibromyalgia, Hyperthyroidism",PNEUMOCOCCAL(PNEUMOVAX)03/27/2017,"erythromycin; povidone iodine topical/ Lisinopril, Kenalog, lidocaine, Bactrim, clindamycin, tetracycline, IVP contrast dye, potassium chloride, pneumococcal 23-valent vaccine,lincosamides, valacyclovir ,sulfamethoxazole -trimethoprim, Metronidazole Hcl, triamcinolone Acetonide, Ace inhibitors, erythropoietin analogues, Potassium, Ondansetron HCL(PF)","['Chest X-ray', 'Chills', 'Cough', 'Dry eye', 'Dry mouth', 'Dyspnoea', 'Electrocardiogram', 'Fatigue', 'Flushing', 'Frequent bowel movements', 'Full blood count', 'Headache', 'Heart rate increased', 'Injection site swelling', 'Metabolic function test', 'Nausea', 'Platelet count', 'Pollakiuria', 'Pyrexia']",1,MODERNA,IM 921489,FL,45.0,M,"12/23/2020 sharp pain left lower breast, chest constriction lasted approx for 2 days on and off. 12/26/2020 swollen left armpit, resolved 01/04/2020. Antibiotic prescription provided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,SEN,,,"High cholesterol, high blood pressure",Flu shot - between 2/2020- 3/2020 flu symptoms for 2 days,,"['Breast pain', 'Chest discomfort', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 921490,MI,58.0,F,Dizziness - has history of vestibular disorder,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Flonase Synthroid,None,Hypothyroidism,Dizziness following flu vaccine,Codeine Narcotics,['Dizziness'],1,MODERNA,IM 921491,MA,30.0,F,"redness, swelling, large circular reaction at injection site around 24 hours post-vaccine. Warm and hurt to touch, swollen lymph nodes in injection armpit. Treated with benadryl, hydrocortisone cream, and ibuprofen. After about 2 days the swelling was nearly gone and it no longer hurt, continues to be a bit darker than rest of arm but no additional symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,"Fluoextine, 70mg/daily Lorazepam, 1mg/as needed Hydroxyzine, 50mg/daily Prilosec OTC, 20mg/daily Women's Multivitamin",,,,"have had reactions to bees, some mosquitoes and other flying insects","['Injection site erythema', 'Injection site swelling', 'Lymphadenopathy', 'Skin discolouration', 'Skin warm']",1,MODERNA,SYR 921493,OH,33.0,F,"At the time of injection 12:20 pm on January 4,2021 the vaccine when being pushed into my arm and after burned really bad. It felt like my arm was on fire for a few minutes but eventually went away. my arm became sore about an hour after the injection but it wasn't bad. a few hours passed and I started noticing my right arm that I received the vaccine in started really hurting and tingling was shooting down my arm and into my fingers. on January 5, 2021 I could not lift my arm with out crying because the pain was so intense. The sight of where the vaccine was administered was red and very swollen. there is a noticeable lifted knot on my arm the size of a gold ball. the sight around the area of administration is red, and sore and warm to touch. the tingling feeling also was present when waking up on Jan 5, 2021. around 230 pm, my arm still very sore and the knot on my arm is still visible and sore to touch. the tingling feeling slowly starting to subside.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,NONE,NONE,NONE,,"Hydrocodone, Percocet","['Burning sensation', 'Injected limb mobility decreased', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Limb mass', 'Pain', 'Pain in extremity', 'Paraesthesia']",UNK,MODERNA, 921495,CT,55.0,F,"on Friday 01-01-21 I was feeling a sore throat. On Saturday, 01-02-21, it was even worse. I took over the counter medication and nothing seemed to happen. On Sunday, 01-03-2021, it was so sore that I could not swallow and the neck was sore to the touch. I went to the emergency room and they ran several tests and it was determined that I experienced an allergic reaction to the dose. They prescribed two (2) medications. I followed their instructions and did not report to work on 01-03 and Tuesday, 01-05-21. The throat is still sore but getting better slowly.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,WRK,lisinprol,none,none,,none,"['Dysphagia', 'Hypersensitivity', 'Neck pain', 'Oropharyngeal pain', 'Pain', 'Tenderness']",UNK,MODERNA, 921496,NH,32.0,F,"Numbness and tingling in right arm beginning shortly after injection (approximately 30mins), progressing to include right side of neck and entire left leg. Lasted until evening of 12/24/20",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,WRK,None,None,None,,None,"['Hypoaesthesia', 'Injection site hypoaesthesia', 'Injection site paraesthesia', 'Paraesthesia']",1,MODERNA,IM 921497,FL,22.0,F,"Four days after getting the vaccine I developed a hive-like rash in the form of elevated, itchy, red spots all over my left arm. Took Benadryl but did not do much and woke up the next day worse and with more spots. Went to critical care and was given prednisone which has helped alleviate it but is not completely gone yet (1/5/2021).",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/03/2021,4.0,PVT,none,none,none,,none,"['Erythema', 'Injection site erythema', 'Injection site rash', 'Injection site swelling', 'Injection site urticaria', 'Rash', 'Swelling', 'Urticaria']",1,MODERNA,IM 921498,WA,35.0,F,"Symptoms: hives across chest, face( 12/29/20 8:20pm), Again on (1/4/2021 3:20pm) severe diarrhea/nausea ( 12/29/20 11:00pm-11am 12/30/2020 and again 1/2/2021) Fever 100* (12/30/2020) Arm Pain (12/29-1/3/2021) Fatigue (12/30-1/5/2021) Stomach Pain/Cramps (12/30-1/4/2021) Treament: ER Visit (12/30/20 4:30pm) IV w/ 20mg IV Pepcid Blood+ Urine Test (WBC was high) Covid Test-Negative Personal Treatment: Pepcid/ Tums/ Bland diet ER VIST (1/4/2021 3:30pm) 20mg IV Pepcid, 25mg IV Benadryl, and 60mg IV solumedrol",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,WRK,"TrazOdone, Mirena IUD",Environmental allergies,"Asthma, migraines, environmental allergies, insomnia, anxiety/panic disorder, Bipolar II, PTSD",,"Paprika, Bell Peppers, Figs","['Abdominal pain upper', 'Diarrhoea', 'Fatigue', 'Nausea', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative', 'Urine analysis', 'Urticaria', 'White blood cell count increased']",1,MODERNA,SYR 921499,KY,58.0,F,"""feels funny"", throat swelling, palpitations and dizzy",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,OTH,Multiple,None,Asthma and Sleep Apnea,Pneumonia-arm swelling,PCNs,"['Dizziness', 'Feeling abnormal', 'Palpitations', 'Pharyngeal swelling']",1,MODERNA,IM 921500,CA,60.0,F,"Received the first dose of vaccine, no problems for 12 hours, then I started to have non-stop shivering and fevers for almost 18 hours then felt better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,01/05/2021,18.0,UNK,none,none,hypertension,,sulfa/latex/bactrim/kiwi,"['Chills', 'Pyrexia']",1,PFIZER\BIONTECH,IM 921501,AL,26.0,M,Patient presented to ER complaining of nausea and vomiting and a frontal headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,none to report,none to report,none to report,,Penicillin and Sulfa Antibiotics,"['Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 921502,NH,56.0,F,"PT states that she felt ""tingly all over"". Then she felt her heart racing and throat felt ""different"". BP checked 100/70, pulse 88. PT continue to feel different in her throat. Agreed to take 25 mg of Benadryl, given at 11:10. 911 was called, patient signed refusal to be evacuated. Patient stayed under the watch of the medical staff until 11:43 when she said she felt fine again and left.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Palpitations', 'Paraesthesia', 'Refusal of treatment by patient', 'Throat tightness']",UNK,MODERNA,IM 921503,,38.0,F,lightheadedness and headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,"levonorgestrel, prochlorperazine, ketoconazole, albuterol, fluticasone, montelukast, sumatriptan",none,"mild intermittent asthma, complicated migraine",,"sulfa (diarrhea), lanolin, levofloxacin","['Dizziness', 'Headache']",1,MODERNA, 921504,ME,24.0,F,"Patient experienced ""something wrong with her throat"", life side of neck and face were numb, left eye was dropping, tongue felt thick. Patient was referred to the ER but was not seen in the ER. Symptoms resolved overnight.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Hypoaesthesia', 'Ophthalmoplegia', 'Oropharyngeal discomfort']",1,MODERNA,IM 921505,WI,36.0,F,"Patient experienced headache, dizziness, light headedness and metallic taste in the mouth a few minutes after receiving the vaccine. Vitals were taken and patient observed for 30 minutes following vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Dizziness', 'Dysgeusia', 'Headache']",2,MODERNA,IM 921506,NJ,54.0,M,"After 20-30 minutes post vaccine dose #1, I experienced headache and dizziness. 1.5 hrs later body aches began. The same for the next day. Sore arm the 3rd day. Fatigue, headache and body aches and joint pains have persisted for the last 10 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,PVT,none,none,none,,none,"['Arthralgia', 'Dizziness', 'Fatigue', 'Headache', 'Pain']",UNK,MODERNA, 921507,IL,36.0,F,"Sore at the injection site, dizzy, chills, vomiting, feverish, tired, back pain",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,SEN,,,,,None,"['Back pain', 'Chills', 'Dizziness', 'Fatigue', 'Injection site pain', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 921508,NJ,65.0,F,"Pfizer-BioNEtch COVID-19 Vaccine Patient felt dizzy while she was getting the COVID-19 vaccine. Patient was waiting to get her vaccine and started feeling anxious, and started having palpitations. These symptoms lasted for a few minutes and then subsided. Patient went to ED for evaluation. 08:06am HR 61, NSR no STEMI. discharged at 8:36 am",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,pantoprazole 40 mg,none,none,,"cephalosporin, contrast agent, nitrofurantoin , oxycodone, quinolone, sulfamethoxazole, penicillin","['Blood glucose normal', 'Dizziness', 'Electrocardiogram normal']",1,PFIZER\BIONTECH,IM 921509,NE,43.0,F,Redness and swelling about 2 inches around site of insertion.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,"metoprolol 25mg po daily, omeprazole 20mg po daily, junell, Zyrtec 10mg po daily",None,,,None,"['Injection site erythema', 'Injection site swelling']",7+,MODERNA,IM 921510,NH,35.0,M,"After 5 or so days I developed my first outbreak of dyshidrotic eczema. I?ve had the tiny bumps appear before but this time the itchy sensation was more intense and i itched which made a rash on my hands , feet and left elbow develop. I?ve had it for a number of days now.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/27/2020,5.0,PVT,None,None,Obesity,,None,"['Dyshidrotic eczema', 'Pruritus', 'Rash', 'Swelling']",1,MODERNA, 921511,OH,35.0,F,"approx-10 Minutes post vaccine, c/o new onset tightness in her throat and epigastric burning, B/P 118/70 pulse 64 Resp 16, denies SOB. Rapid Response called when it did not resolve. They arrived, vs stable, they took her to ED per wheelchair. On the way to the ED, patient refused to go and went home. Was advised to call 911 if any breathing difficulty or return to ED if symptoms didn't resolve.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Dyspepsia', 'Throat tightness']",1,MODERNA,IM 921512,MI,58.0,F,Immediate dizziness. Hx of similar reaction with injections,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Synthroid Flonase,None known,None known,similar reaction to flu vaccine,Codeine Narcotics,"['Dizziness', 'Immediate post-injection reaction']",1,MODERNA,IM 921513,WI,58.0,F,"The evening after receiving the vaccine, at 2130 started with chills which advanced to sweats and chills through the night. Awoke Sunday morning with joint and body aches, headache and fatigue. Later that afternoon started with a fever- 100.3 and was not able to work the following day. Symptoms resolved in the afternoon on 1/4",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,WRK,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Impaired work ability', 'Night sweats', 'Pain', 'Pyrexia']",UNK,MODERNA, 921515,IL,47.0,F,"BODY PAIN, FATIGUE, SORE INJECTION SITE, HOT FEET",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,SEN,NONE,NONE,NONE,,NONE,"['Fatigue', 'Feeling hot', 'Injection site pain', 'Pain']",1,MODERNA,IM 921516,NJ,47.0,F,"Left deltoid, injection site was painful, red, swollen, hard and hot to the touch for about 20 hours the following day, which completely resolved within 24 hours. A week later, this morning the injection site started itching, developed into a red raised, hardened bump, like it was a week ago. It's itchy, red, swollen, hot to the touch, not painful, close to a quarter in size. No other adverse reactions at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/05/2021,7.0,WRK,Ibuprofen,none,Exercise induced asthma,,"IV contrast, penicillin","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA, 921517,DC,43.0,F,"had occasional diarrhea for about 24 hours, got shot on 12/21/2020 and had diarrhea 4 times on 12/22/2020, also felt tired.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,WRK,"synthroid 75mcg, vit D 200IU, Spironolactone 50mg BID, Allegra, Omeprazole",none,"Hashimoto's disease, GERD, Anti-centromere antibodies (unknown what disease)",,none,"['Diarrhoea', 'Fatigue']",1,PFIZER\BIONTECH,SYR 921518,CA,45.0,F,12 hours after the vaccine my right hand was really cold. There was a significant difference in the temperature of the left hand.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/21/2020,1.0,UNK,"I take ibrance, letrazole daily & xgeva and zoladex injections monthly.",No,Stage 4 Breast cancer,,"I am allergic to shrimp, amoxicillin and Midrin","['Directional Doppler flow tests', 'Peripheral coldness', 'Ultrasound Doppler']",1,PFIZER\BIONTECH,IM 921520,TN,55.0,F,"noted swollen lymph node left armpit area, slightly tender",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/31/2020,8.0,PVT,vitamin D,none,"sleep apnea, vitamin d deficiency",,none,"['Lymphadenopathy', 'Tenderness']",1,PFIZER\BIONTECH,IM 921521,VA,20.0,F,"Temp of 100.9, body aches, upset stomach, cold chills, and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Sprintec Fe,"COVID-19. Tested on 24th of December, released on 2nd of January. Received vaccine on 4th of January.",Auto-Immune disorder to histamines.,,I have a histamine intolerance.,"['Abdominal discomfort', 'Body temperature increased', 'Chills', 'Feeling cold', 'Headache', 'Pain']",1,PFIZER\BIONTECH,SYR 921522,IL,36.0,F,"Sore at the injection site, Dizzy, Chills, Vomiting, feverish, Tired, and back pain",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,SEN,,,,,,"['Back pain', 'Chills', 'Dizziness', 'Fatigue', 'Injection site pain', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 921523,ID,43.0,F,"Restricted respiration , muscle ackes and pain on my body, severe menstrual cramps from my abdomen to my armpit ( new and not experienced before).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,,,,,Dairy,"['Abdominal pain', 'Dysmenorrhoea', 'Dyspnoea', 'Muscle spasms', 'Myalgia', 'Pain']",,PFIZER\BIONTECH,SYR 921524,CA,57.0,M,"Pfizer covid vaccine is administered using the 1mL vanish point syringe provided by manufacturer. The needle has a self-retracting feature for safety. During administration, the self-retracting feature was initiated and the patient did not receive the full dose of covid vaccine. the nurse witnessed splashing of medication outside of the patient's arm. the patient did have a break in skin from the needle, but uncertain if full dose administered. Supervisor, notified pharmacy and dr. dr came to bedside, spoke with patient and consulted with dr. and dr. in Pfizer vaccine vial, overfill dose of 0.2mL was ordered and administered. patient agreed. 0.2 mL supplemental dose was given as ordered. pt given v-safe instructions and monitored for 15 minutes after last administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,01/05/2021,19.0,WRK,,,,,,"['Incorrect dose administered', 'Syringe issue']",1,PFIZER\BIONTECH,IM 921525,OH,94.0,F,"very agitated, unusually low blood sugars, feeling of something crawling under her skin, picking at and cutting fingers",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/04/2021,4.0,UNK,,,"Type 2 diabetes, Edema, hypertension, osteoarthritis, hyperlipidemia",,,"['Agitation', 'Blood glucose decreased', 'Dermatillomania', 'Formication']",UNK,MODERNA, 921526,CA,13.0,F,Moderna Covid Vaccination administered to patient less tan 18 years old,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Claritin 10 mg oral tablet, 10 mg, 1 Tab, ORAL, DAILY, 5 refills Flonase 50mcg/inh nasal spray, 2 Spray, NASAL, As directed fluoride 1 mg oral tablet, chewable, See Instructions, 3 refills",Irregular Menses,None Known,,None Known,['Product administered to patient of inappropriate age'],1,MODERNA,IM 921527,CO,28.0,F,"7 days after injection, injection site swollen, red, hot, itchy, began as a few red dots, grew larger and swelled together into a big red blob 8 days after injection, fatigue, runny nose",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,01/02/2021,7.0,PVT,,,,,sesame seeds,"['Fatigue', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Rhinorrhoea']",1,MODERNA,IM 921528,WV,32.0,F,"Hives from head to toe, Itching really bad, nausea , and diarrhea Took Benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,Losartan hidropizie combo pill Zoloft Allegra Vitamin D3,Covid Positive,Hypertension Blood clot in lungs Reactive airway disease,,Shell Fish Iodine,"['Diarrhoea', 'Nausea', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 921529,MN,56.0,M,"Tingling in right arm and hand a few minutes after getting the vaccine. Sat and rested for 15 minutes, evaluated by paramedic and RN and then was given a ride home. Patient reported the tingling did not get any worse and stayed about the same.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PUB,,Eye surgery on 12/10/2020,,,,"['Injection site paraesthesia', 'Paraesthesia']",2,MODERNA,IM 921530,MI,58.0,F,"Dizziness, loss of vision",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Flonase Synthroid,None known,hypothyroidism dizziness,Similar reaction to flu vaccine,Codeine Narcotics,"['Blindness', 'Condition aggravated', 'Dizziness']",1,MODERNA,IM 921531,CA,60.0,F,tired Chills Muscle aches Throat irritation weakness no energy hot flashes,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Asthenia', 'Chills', 'Fatigue', 'Hot flush', 'Myalgia', 'Throat irritation']",1,PFIZER\BIONTECH,SYR 921532,TX,67.0,F,"""9 DAYS LATER, REDNESS AND WARM TO TOUCH TO LEFT ARM INJECTION SITE"".",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,01/04/2021,9.0,PVT,NONE,,,,,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,IM 921533,TX,59.0,F,STATES SHE DEVELOPED INTENSE ITCHING. SHE AND HER DOCTOR THINK IT IS FROM THE VACCINE. STARTED ON STEROIDS TODAY.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,PVT,UNKNOWN,NO,UNNOWN,,NONE,['Pruritus'],1,PFIZER\BIONTECH,IM 921534,IL,50.0,F,"trouble swallowing after receiving a Covid vaccine. �She received the vaccine at 830, approximately 20 minutes prior to her emergency department arrival. �10 minutes later she began to feel her throat swelling and noted it was difficult to swallow",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Advair, albuterol, flexaril, Lexapro, singular,",,"eosinophilic esophagitis, asthma",,"blackberry, succinylcholine, Bactrim D, iodine","['Dysphagia', 'Pharyngeal swelling']",1,MODERNA,IM 921537,NH,25.0,F,"Patient reported scratch/tightening throat. (Clinical Observer) administered Benadryl 12.5mg one time and observed patient. Patient alert, talking, no respiratory distress throughout. No signs or symptoms of facial, mouth, or lip swelling. Patient reported symptoms regressing as time passed. Patient was able to safely leave the site.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,OTH,,,,,Aspergillus,"['Throat irritation', 'Throat tightness']",1,MODERNA,IM 921538,ME,47.0,F,"Increasing pain at injection site followed by itching at injection site and progressing to large area of urticaria covering injection site and shoulder with white spot at site of injection. Progressed to diffuse hives across chest, up neck, covering face and head with swelling including swelling of lips. Sought medical attention by agency Medical Director and on phone with PCP then to an urgent care center. Course of treatment included prednisone and antihistamine for 6 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,PVT,not known,not known,not known,,not known,"['Generalised oedema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site urticaria', 'Urticaria']",1,MODERNA,IM 921539,ME,31.0,F,"Throat tightness, tongue swelling ~30 minutes following vaccine. No hx of anaphylaxis. Symptoms resolved with benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,Sulfa drugs,"['Swollen tongue', 'Throat tightness']",1,MODERNA,IM 921540,NE,36.0,F,Beginning 1/1/2021 the small lump (marble sized) in my arm grew to about 3 marble sizes (all put together). It was a raised area that was red and hot in a circular shape that was 4 inches across. Remained this was until 1/5/2021. It was painful to move the arm (2/10). I used Tylenol for discomfort and ice to the site. Helped some.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/01/2021,6.0,WRK,"vitamin D 1000 IU daily, acetaminophen 1000mg daily as needed",None,Obesity,,Sulfa,"['Erythema', 'Limb discomfort', 'Limb mass', 'Pain', 'Peripheral swelling', 'Skin warm']",1,MODERNA,IM 921541,IA,50.0,F,"Day 6 after vaccine I developed three raised and hard spots in the from of a smiley face, one with two below. They sore, itched and were red to look at. Its now day 9 and they are still the same.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/03/2021,7.0,PVT,Humalog Atorvistatin Zoloft Metoprolol Losartin VD 2 VD 3 Zinc Vitamin B Complex,none,chronic pancreatitis diabetes heart disease,,PCN,"['Erythema', 'Induration', 'Pain', 'Pruritus', 'Swelling']",1,MODERNA,IM 921542,WI,42.0,F,"Patient had sharp pains in arm after COVID-19 vaccine near injection site. Observed patient for 30 minutes and gave a cold compress. Patient returned to work and later reported palpitations and ""heart racing."" Checked vitals BP 130/80 and HR in the 80's. HR later jumped to 100's.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,,,,,Sulfa Drugs,"['Heart rate increased', 'Pain in extremity', 'Palpitations']",1,MODERNA,IM 921543,MI,50.0,F,"First couple days, arm painful and headaches. Plum sized area of redness and hardness. right arm has some roughness. Last two night horrible leg cramps.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,WRK,Synthroid,no,Hypothyroidism,,Capsoul,"['Headache', 'Injection site erythema', 'Injection site induration', 'Muscle spasms', 'Pain in extremity']",1,MODERNA,IM 921544,,38.0,F,"lightheadedness, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,"levonorgestrel, prochlorperazine, ketoconazole shampoo, albuterol, fluticasone, Montelukast, sumatriptan",none,"mild intermittent asthma, complicated migraine",,"sulfa, lanolin, levofloxacin","['Dizziness', 'Headache']",1,MODERNA, 921545,WA,55.0,F,"10 minutes after vaccine I got a warm rush up left neck to left side of head with and instant severe headache which I would rate 9/10, dizziness, nausea and felt like I was about to pass out. After about 10 minutes the headache and dizziness eased but headache remained at 6/10. 40minutes after vaccine the nausea returned much worse, my ears felt full & tongue felt weird. Took 2 Benadryl, slept 12hours. Next morning: I still have headache which migraine medicine not Aleves are helping. My tongue still feels weird, my lips and nose feel numb.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,"Singular, Tramadol, Gabapentin, Trazadone, Cymbalta, vitamin C",None,Asthma Macular degeneration,,Sulfa Lavender,"['Dizziness', 'Ear discomfort', 'Headache', 'Nausea', 'Paraesthesia oral']",1,MODERNA, 921546,WA,34.0,M,SOON AFTER ADMINISTRATION EXPERIENCED BURNING SENSATION STARTING LEFT SHOULDER RADIATING ACROSS CHEST AND DOWN LEFT ARM.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,,none,"hypertension, diabetes",,none,"['Burning sensation', 'Chest X-ray normal', 'Chest pain', 'Electrocardiogram normal']",1,MODERNA,IM 921547,AR,65.0,M,"DEATH ON 1/4/2021, RESIDENT RECIEVED VACCINE ON 1/2/20",Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/04/2021,2.0,SEN,Acetaminophen Tablet 325 MG Give 2 tablet by mouth every 6 hours as needed for Pain. elevated Temp. Phone Active 05/08/2020 05/08/2020 AmLODIPine Besylate Tablet 10 MG Give 1 tablet by mouth one time a day related to ESSENTIAL (PRIMARY) HYP,"CEREBRAL INFARCTION, UNSPECIFIED(I63.9), LONG TERM (CURRENT) USE OF ASPIRIN(Z79.82), VITAMIN DEFICIENCY, UNSPECIFIED(E56.9), ACUTE KIDNEY FAILURE, UNSPECIFIED(N17.9), HYPERKALEMIA(E87.5), ACUTE RESPIRATORY FAILURE, UNSPECIFIED WHETHER WITH HYPOXIA OR HYPERCAPNIA(J96.00), PURE HYPERCHOLESTEROLEMIA, UNSPECIFIED(E78.00), PAIN IN RIGHT FOOT(M79.671), ESSENTIAL (PRIMARY) HYPERTENSION(I10), ACIDOSIS(E87.2), ABNORMAL LEVELS OF OTHER SERUM ENZYMES(R74.8), HYPERLIPIDEMIA, UNSPECIFIED(E78.5), DISORDER OF THYROID, UNSPECIFIED(E07.9), GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS(K21.9), MUSCLE WASTING AND ATROPHY, NOT ELSEWHERE CLASSIFIED, UNSPECIFIED SITE(M62.50), MUSCLE WASTING AND ATROPHY, NOT ELSEWHERE CLASSIFIED, MULTIPLE SITES(M62.59), COGNITIVE COMMUNICATION DEFICIT(R41.841), UNSPECIFIED LACK OF COORDINATION(R27.9), OTHER DYSPHAGIA (R13.19), OTHER CHRONIC PAIN(G89.29), HYPOTHYROIDISM, UNSPECIFIED(E03.9), DRY EYE SYNDROME OF UNSPECIFIED LACRIMAL GLAND (H04.129), METABOLIC ENCEPHALOPATHY(G93.41), UNSPECIFIED CONVULSIONS(R56.9), POLYNEUROPATHY, UNSPECIFIED(G62.9), TYPE 1 DIABETES MELLITUS WITH UNSPECIFIED DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA(E10.319), NASAL CONGESTION(R09.81), BRONCHITIS, NOT SPECIFIED AS ACUTE OR CHRONIC(J40), HYPOKALEMIA(E87.6), ELEVATED WHITE BLOOD CELL COUNT, UNSPECIFIED(D72. 829), OTHER MALAISE(R53.81), CELLULITIS OF RIGHT LOWER LIMB(L03.115), CELLULITIS OF LEFT LOWER LIMB(L03.116), EDEMA, UNSPECIFIED (R60.9), IRON DEFICIENCY ANEMIA, UNSPECIFIED(D50.9), CUTANEOUS ABSCESS, UNSPECIFIED(L02.91), COVID-19(U07.1)",UNCONTROLLED DIABETES MELLITUS ON INSULIN,,NKDA,['Death'],1,MODERNA,IM 921548,WV,30.0,F,"Patient received vaccine on 12/17/2020 at approximately 12pm. At 10pm that day, patient developed chills and fatigue. At 6am on 12/18/2020, patient developed fever (temperature 100.2) and a very sore arm. Patient took acetaminophen (Tylenol) at 6:30am for the fever and pain. By 1pm on 12/18/2020, patient reports headache and dizziness. Patient took Rizatriptan (Maxalt) for the headache and dizzy, but it did not help. Patient took ibuprofen at approximately 4pm. Patient felt normal at 5:30pm on 12/18/2020. Took Tylenol at 6:30 for the sore arm. Took Maxalt for the headache/dizziness (sometimes migraines make me dizzy, maxalt didn?t help). Took ibuprofen around 3-4ish? And felt fine by 5:30.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,Prescription: Syeda (ethinyl estradiol & drospirenone) Cetirizine (Zyrtec) 10 mg QD Buspirone (Buspar 7.5 mg BID PRN (Typically taken at night to aide sleep) OTC: Fluticasone (Flonase) PRN,Nothing to Report.,vestibular neuritis - diagnosed in May/June 2019 perennial allegies,,Allergies: sulfa drugs (rash) codeine intolerance (vomiting),"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 921549,CA,61.0,F,"Headache, fever, chills, cough, congestion, malaise, patient reports she has been ""down"" since Saturday and is still experiencing all of these symptoms overall. Patient has been taking TheraFlu",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/01/2021,4.0,PVT,Regular medication,,,,,"['Chills', 'Cough', 'Depressed mood', 'Headache', 'Malaise', 'Nasal congestion', 'Pyrexia']",UNK,PFIZER\BIONTECH, 921550,MO,63.0,F,hives/rash all over body that lasted 3 days. Called PCP and prescribed medications to help with allergic response.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,yes,none,"hypertension, Type 2 Diabetes, neurophathy",,"streptomycin, doxycycline, clamara, sulfer","['Hypersensitivity', 'Rash', 'Urticaria']",UNK,MODERNA,SYR 921551,CA,27.0,M,chills headache body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Chills', 'Headache', 'Pain']",1,MODERNA,SYR 921552,MI,46.0,F,"Received the vaccine on December 29, 2020. On Saturday, January, 2, 2021, the patient started itching in her bilateral breast area. Did not look to see if there was a rash at that time. On Tuesday, January 5, 2021, the patient was getting ready for work in the morning and her bilateral breasts started itching again. She looked down and noticed that she had a long red rash across her medial breasts. She applied a topical cream to the affected area and she states that the itching has improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,PVT,Tylenol Amitriptyline omeprazole hydroxyzine cyclobenzaprine cymbalta montelukast xenical modafinil Entyvio - every 8 weeks (last dose 11/11/2020),none,Chrohn's sleep apnea fibromyalgia arthritis,H1N1 vaccine. Got really sick with flu like symptoms,Sulfa nickel percocet vicodin tomatoes some soaps,"['Pruritus', 'Rash']",1,MODERNA,IM 921553,TX,19.0,F,"19 yo female received COVID Vaccines at 0930, reported to Primary care around 1200 pm with pruritus, erythema and warmth on upper extremities, chest and back. Airway intact, Lungs CTA bilar, NEURO WNL, VS wnl. Will tx for mild allergic reaction, Educated on Anaphylaxis protocol. SM v/u",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,MIL,,,,,NKA,"['Erythema', 'Hypersensitivity', 'Pruritus', 'Skin warm']",1,MODERNA,IM 921554,TX,48.0,F,"Hives, swelling in throat and lips. Used Epi pen and Benadryl. Went to ER Medical Center. Given Solu-Medrol IV and oral prednisone 60mg for 5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,"metformin 1000mg, pepcid 20mg, wellbutrin 150mg, zyrtec 10mg",No,PCOS,,Phenergan,"['Lip swelling', 'Pharyngeal swelling', 'Urticaria']",1,MODERNA,IM 921555,LA,53.0,F,HEADACHE ON DAY 1 AND 2 AND 3 THEN SORENESS ON DAY 3 AND THEN FAST HEART BEAT ON DAY 4 AND CHILLS ON DAY 7 AND REDNESS AND WARMTH TO TOUCH AND MUCH ITCHING ON DAY 5 UP TO NOW,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,OTH,"hctz, herbal tea, gabapentin",none,htn resolved since Aug 2019,52/11/2017/FLU VACC,"pcn, biaxin, clyndamycin","['Chills', 'Erythema', 'Feeling hot', 'Headache', 'Heart rate increased', 'Pain', 'Pruritus']",1,MODERNA,IM 921556,AZ,55.0,F,"I got headache, fever, vomitting , rash all over body. got symptoms after taking the covid-19 vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PUB,"Atorvastatin, Glimepiride, Metformin","Diabetes, Lyken Plantus",Diabetes,"flu vaccination, age 53 years. two years ago",unknown,"['COVID-19', 'Headache', 'Pyrexia', 'Rash', 'SARS-CoV-2 test positive', 'Vomiting']",1,MODERNA,SYR 921557,MN,74.0,M,Began experiencing increased temp of 101.4 on 1/4/2021 at 0701. Temp did not resolve with the use of Tylenol. HR increased to >100 and BP was decreasing below baseline. Increased weakness also noted. Temp increased to 102.9 on 1/4/2021 at 2220. Transferred from SNF to ER for evaluation.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/03/2021,01/04/2021,1.0,SEN,"cholecalciferol, iron, oxycodone, gabapentin",,"obesity, GERD, allergic rhinitis, neuropathy, insomia, ataxia, hyperlipidemia",,"cosopt, weeds, soaps","['Asthenia', 'Blood pressure decreased', 'Body temperature increased', 'Chest X-ray normal', 'Heart rate increased', 'Hyponatraemia', 'Metabolic function test abnormal', 'Urine analysis normal']",1,MODERNA,IM 921558,NY,24.0,F,"Sore arm/neck, fever for approx. 36 hours up to 102.3 F, headache, body aches, chills - symptoms ended after 36 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Duloxetine, Methylphenidate, Vitamin D 50000 IU (2X a week), Vitamin D 2000 IU, Xyzal",,,"Influenza, redness at the injection site",,"['Chills', 'Headache', 'Neck pain', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 921559,FL,40.0,F,"Given vaccine on Dec 28th, Approx 2 hrs afterwards felt very tired. (feels same after flu shot). Then on the 29th was nauseated and vomited X 2. On Jan 1st was feeling better, but got up to walk and felt dizziness, nausea and vomiting continues. Can keep down liquids, but unable to eat anything.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,Citaloprim 20 mg; Multivitamin,none,Anxiety,,Morphine; intolerance to meat proteins,"['Decreased appetite', 'Dizziness postural', 'Fatigue', 'Nausea', 'Vomiting']",1,MODERNA,IM 921560,TX,50.0,F,"temperature between 100.5 to 101.8, swelling of L arm (sever) and pain into arm pit, swelling of lymph nodes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,SEN,"topiramate, duloxatine, ibuprofen 800",,,,,"['Axillary pain', 'Body temperature increased', 'Lymphadenopathy', 'Peripheral swelling']",1,PFIZER\BIONTECH,IM 921561,UT,38.0,F,"Fever, headache, body ache, chills, sore throat, headiness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PUB,Levothyroxine; Emgality; B12/D3; melatonin,None,"Migraines, hypothyroidism",,Penicillin,"['Chills', 'Discomfort', 'Headache', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 921562,OH,95.0,M,"Red rash all over back, upper left arm and across stomach area. Gets more red with application of rash cream.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/02/2021,2.0,UNK,,,"Type 2 Diabetes, Hyperlipidemia, hypertension, chronic kidney disease, second degree atrioventricular block, GERD",,"sarni-, mentho-, camphor","['Injection site rash', 'Rash', 'Rash erythematous']",UNK,MODERNA,SYR 921563,TX,51.0,F,"Fatigue, joint pain and body ache within 5 hours of vaccination. Migraine, nausea, difficulty swallowing swollen lymph nodes within 18 hours of vaccination. Resolved with rest.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,Mutlivitamin,none,none,,none,"['Arthralgia', 'Dysphagia', 'Fatigue', 'Lymphadenopathy', 'Migraine', 'Nausea', 'Pain']",1,MODERNA,IM 921564,TX,50.0,F,"Upon administration, felt an immediate thickening on left side of throat and numbness on left side of face under eye and on cheek bone. Associate stayed for observation period of 15 minutes and was released to return to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Hypoaesthesia', 'Throat tightness']",UNK,MODERNA,IM 921565,TX,45.0,F,Fevers myalgias arthralgias,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/15/2020,12/28/2020,13.0,PVT,None,None,None,,None,"['Arthralgia', 'C-reactive protein', 'Computerised tomogram', 'Full blood count', 'Influenza virus test', 'Metabolic function test', 'Myalgia', 'Pyrexia', 'Red blood cell sedimentation rate', 'SARS-CoV-2 test', 'Streptococcus test']",1,PFIZER\BIONTECH,IM 921566,CA,8.0,M,Covid Vaccine given to person less that 18 years old. No complications at this time,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Adderall XR 5 mg oral capsule, extended release, 5 mg, 1 Cap, ORAL, QMorning",ADHD,ADHD,,None Known,['Unevaluable event'],1,MODERNA,IM 921567,WI,23.0,F,"3 hours after vaccination patient experienced nausea, diarrhea, chill, and headache. Patient given 1000 mg of acetaminophen. Patient did not clear up symptoms after 6 hours and was sent home from work.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,,,,,none,"['Chills', 'Diarrhoea', 'Headache', 'Nausea']",1,MODERNA,IM 921568,NY,41.0,F,"injection site reaction that started a full week after injection - itching, redness, underlying firmness, tender axillary node resolved on its own in a few days without intervention",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/31/2020,7.0,WRK,"valacyclovir, multivitamin, probiotic, magnesium",none,none,,shellfish leads to hives and GI upset,"['Axillary pain', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site reaction']",1,MODERNA,IM 921569,WI,39.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA I recieved the vaccine at 0800 on 1/2/21. By 1430 I started feeling tired with some chills. By 1700, I was having nausea and vomiting. I woke the next day (1/3) around 0700 still having nausea, but also my hands and feet were very cold and my arms and legs were cold and clammy. This continued throughout the day. It is now 1/5 and I'm still having some nausea and my extremities are still cold and will sometimes tingle.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,Vitamin D gummies,,"Arthritis, hip replacement, Calcified DVT",,Aspirin,"['Chills', 'Cold sweat', 'Fatigue', 'Nausea', 'Paraesthesia', 'Peripheral coldness', 'Vomiting']",1,PFIZER\BIONTECH,IM 921570,IL,32.0,F,Pt reported swelling of the tongue within about 1 hr of vaccine administration.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,,['Swollen tongue'],1,MODERNA,IM 921571,,38.0,F,"lightheadedness, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,"levonorgestrel, prochlorperazine, ketoconazole shampoo, albuterol, fluticasone, montelukast, sumatriptan",,"mild asthma, migraine",,"sulfa, lanolin, levofloxacin","['Dizziness', 'Headache']",1,MODERNA, 921572,WI,87.0,M,"Resident had body aches, a low O2 sat and had chills starting on 12/30/20. He had stated that they had slightly improved. On 1/1/21 he sustained a fall with a diagnosis of a displaced hip fracture. On 1/2/21 during the NOC shift his O2 sat dropped again. He later went unresponsive and passed away.",Yes,01/02/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,SEN,"Fluticasone, Lasix, Omeprazole, Sucarafate, Ropinrole HCl",Heart Failure,"Chronic Kidney Disease, Atherosclerotic Heart Disease",,"Lisinopril, Losartan","['Chills', 'Death', 'Fall', 'Hip fracture', 'Oxygen saturation decreased', 'Pain', 'Unresponsive to stimuli']",1,MODERNA,IM 921573,NE,32.0,F,DEVELOPED DIZZINESS AND NAUSEA SHORTLY AFTER VACCINATION. WAS BROUGHT BY PRIVATE VEHICLE TO EMERGENCY ROOM. SYMPTOMS LASTED ~1 HOUR.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,,"['Dizziness', 'Nausea']",1,PFIZER\BIONTECH,IM 921574,TX,27.0,F,After administration of vaccine patient stared feeling tired with bodyaches and runny nose.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/28/2020,5.0,PUB,,,,,,"['COVID-19', 'Fatigue', 'Pain', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,MODERNA,IM 921575,MS,43.0,F,"Patient started experiencing a ""tingling"" at the injection site. There was also flushing of the left arm. Then started to experience right flank and back pain. Never experienced respiratory difficulty or distress. Patient was sent to the emergency department. Patient received Solumedrol, Pepcid, and Zyrtec in the emergency department (allergic to Benadryl)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Back pain', 'Flank pain', 'Flushing', 'Injection site paraesthesia']",1,MODERNA,IM 921576,WA,55.0,F,"10minutes after vaccine: dizziness, nausea, severe headache 9/10, about to pass out. 20minutes after vaccine: felt a little better, dizziness eased, headache 6/10. 40minutes after vaccine: severe nausea, tongue felt weird heavy like, ears felt full, headache 7/10- I took 2 Benadryl and slept 12 hours straight. Next day: headache 6/10 feels like migraine but migraine medicine nor helping, nose &lips feel numb. Taste is off.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PVT,Singular Tramadol Gabapentin Cymbalta Vitamin c Magnesium,None,Asthma Macular degeneration,,Sulfa Lavender,"['Dizziness', 'Ear discomfort', 'Headache', 'Hypoaesthesia', 'Migraine', 'Nausea', 'Paraesthesia oral', 'Taste disorder', 'Tongue disorder']",1,MODERNA, 921577,IN,52.0,F,"APPROXIMATELY 8 -10 MINUTES AFTER THE VACCINE MY HEART RATE INCREASED, KIND OF SUDDENLY - SHORLY AFTER THAT I FELT A 'RUSH' FROM HEAD TO TOE. ALL OF THIS HAPPENED OVER MAYBE 20 SECONDS - THEN MY HR DECREASED TO NORMAL AND I FELT FINE.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,PAROXETINE 10MG QDAY; LUNESTA 3MG QHS; ZYRTEC DAILY; ATENOLOL 15MG 1/2 TAB QHS,NONE,MIGRAINES; HYPERTENSION,,NKA,"['Heart rate increased', 'Sensory disturbance']",1,PFIZER\BIONTECH,IM 921578,FL,50.0,F,"At 0919 I was made aware that this Team Member (TM) was complaining of being dizzy and fast heart rate. Face flushed and respirations labored. Tm given water and crackers. At 0927 TM stated "" I am not really felling well."". TM hyperventilating , face flushed. Rapid Response Team ( RRT) called. Tm transferred to a gurney and moved to another room for privacy. RN RRT and APRN responded to code. 0932 Benadryl 50 mg given by mouth. 0938 . Dr. responded. Per Dr., Most likely a vasovagal response but requested TM call a family member to pick her up. 0940 VS BP 145/94 P 97. 1003 Resting with her eyes closed, respirations even, non labored. 1026 Assisted bby this nurse to her husbands car.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,BP Med Biotin Collagen,,HTN,,NKA,"['Dizziness', 'Dyspnoea', 'Flushing', 'Heart rate increased', 'Hyperventilation', 'Malaise', 'Presyncope']",1,MODERNA,IM 921579,,33.0,M,"Employee got the Pfizer lot EL1284 on 01-04-2021 in left arm. There is now a bump about quarter of an inch high. It is not painful or itchy. Will keep an eye on it, use ice and Tylenol as needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,,,,,,['Injection site swelling'],1,PFIZER\BIONTECH,IM 921582,CT,37.0,F,"Initial injection administered was empty syringe, resulting in pain and bleeding at injection site. Error was identified immediately and actual injection was administered into left arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,,,,,,"['Injection site haemorrhage', 'Injection site pain', 'Wrong technique in product usage process']",1,MODERNA,IM 921583,FL,20.0,U,"Discrepancy Noted: Five (5) vials that was supposed to contain (10) doses per vial contained only (9) doses. Clinic received 250, 5ML (10) dose vials in a shipment received 12/22/2020. At onset of vaccinations, the Immunizations Clinic noted five of the vials did not contain the appropriate amount of vaccine as stated per the manufacturer. No adverse impact. No mission degradation. Inquiry is submitted to address this discrepancy on current and future vaccine shipments.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,MIL,UNKNOWN,UNKNOWN,UNKNOWN,,UNKNOWN,"['Manufacturing product shipping issue', 'No adverse event', 'Product packaging quantity issue']",UNK,MODERNA,IM 921584,WI,43.0,F,"patient complained of tingling extremities (legs, hands and feet). She also complained of feeling slightly faint and dizzy. she did not pass out. She did not have shortness of breath or palpitations. She also felt weak. We had the patient lay down and elevate legs/feet. about 15 minutes after that she was feeling back to her normal self.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,unknown,none noted at the time of vaccination. see below for chronic conditions,"Stage III Chronic Kidney Disease, hoshimotos thyroiditis",,no known allergies,"['Asthenia', 'Dizziness', 'Paraesthesia']",1,MODERNA,IM 921585,NE,56.0,F,"DEVELOPED CHILLS, BODY ACHES, AND FATIGUE. LASTED APPROXIMATELY 24 HOURS BEFORE RESOLVING.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,SEN,,,,,,"['Chills', 'Fatigue', 'Pain']",1,PFIZER\BIONTECH,IM 921587,GA,22.0,F,"Woke up on 1/3 with a bad headache, symptoms progressed into a 102.7 fever, severe chills, body aches, fatigue, and diarrhea. Symptoms have subsided except headache as of 1/5",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,UNK,None,Sinus infection,None,,None,"['Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Influenza virus test negative', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 921588,TN,36.0,F,"I have learned that it was syncope. I felt like time was moving quickly. I was jittery and felt like my heart was beating quickly. I was taken to a separate area and felt warm and flush in my chest. They laid me down on the cot and said I looked pale. My hands were cold and within minutes I was shaking uncontrollably. I think it was an anxiety related to my research I've done at my job related to COVID. I don't think it was an allergic reaction, but I do have an appt on Thursday. I was monitored for about an hour. Symptoms went away but I wasn't totally ok until the next day besides soreness in next arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,WRK,Zyterk Singulair Nasocort (nasal spray) Also have an IUD Took Tylenol at 7am on day of vaccination,,Asthma,,Cephalexin,"['Anxiety', 'Feeling hot', 'Feeling jittery', 'Flushing', 'Heart rate increased', 'Pallor', 'Peripheral coldness', 'Syncope', 'Time perception altered', 'Tremor']",1,PFIZER\BIONTECH,IM 921589,MD,57.0,F,"Client had no issues on 12/29/2020 - the day of the Covid 19 vaccine. At 6:00 AM on 12/30/2020 she c/o of nausea, headache, felt as if she had been hit by a sledge hammer and had chills. she stayed in bed from 12/30/2020 until she went to Hospital ER on 1/4/2020. She reported to me that she had a chest x-ray that showed ""double viral pneumonia"". On 1/5/2021 she received a telephone call that she tested positive for Covid 19. She reported these events to her manager who reported it to County, Health Officer, who then reported it to me. I called the client to get all of the facts regarding the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PUB,Benicar Bystolic,None according to client,Hypertension for 10 years,,Amoxicillin Penicillin,"['COVID-19', 'Chest X-ray abnormal', 'Chills', 'Feeling abnormal', 'Headache', 'Mobility decreased', 'Nausea', 'Pneumonia', 'Pneumonia viral', 'SARS-CoV-2 test positive']",UNK,MODERNA, 921590,NJ,50.0,F,"Patient became anxious, nauseated and very fussy 20 minutes after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,,,,,,"['Anxiety', 'Emotional distress', 'Nausea']",1,PFIZER\BIONTECH,IM 921591,IA,29.0,M,Swelling of left side of face and neck same side as vaccination. Severe ear pain/possible ear infections thought to also have lymphadenopathy.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,None,None,None,,None,"['Ear pain', 'Swelling', 'Swelling face']",1,MODERNA,SYR 921592,NJ,54.0,M,Patient complained of itching on left cheek. Given 25 mg Benadryl and juice itching resolved after 10 minutes,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,,none,allergies,,history of allergies,['Pruritus'],1,PFIZER\BIONTECH,IM 921593,TX,27.0,F,"Red Ring around injection, swollen, itchy, hot to touch, and wheezing. Patient took benadryl, iced and rested. Patient's PCP prescribed zpack and steroids.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,,,,Yes,"['Condition aggravated', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Wheezing']",1,MODERNA,IM 921594,CA,15.0,F,Covid Vaccination given to person less than 18 years. No complications at this time,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,None,Mental Health Issue,,,None Known,"['Product administered to patient of inappropriate age', 'Unevaluable event']",1,MODERNA,IM 921595,MA,53.0,F,"Received the COVID vaccine at work in her left deltoid 40 minutes prior to arrival to the ER. Within 5 minutes of receiving it, serial blood pressure readings began rising, her arm felt heavy, and she developed an uncontrollable tremor primarily in her left arm with what appears to be generalized shivering. Associated with significant anxiety. She has never had an allergic reaction before. No associated shortness of breath or wheezing. No lip tongue or throat swelling. No pruritus or hives. No nausea or vomiting. She was treated for possible dystonic reaction initially with two doses of Benadryl 25mg IV, then 1mg of IV lorazepam, and finally 125mg solumedrol. Symptoms improved significantly with Benadryl, and then resolved entirely after lorazepam. She was discharged home to complete 4 more days of 50mg prednisone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,none,none,"asthma, chronic neck pain, GERD, nodular goiter, OSA but not requiring CPAP",,none,"['Anxiety', 'Blood pressure increased', 'Chills', 'Electrocardiogram normal', 'Limb discomfort', 'Tremor']",UNK,PFIZER\BIONTECH,IM 921596,NY,58.0,F,"Reports hives five days after vaccination, redness on arm six days after vaccination, not hardened but soft, applied hydrocortisone cream to reddened affected area., followed by red ""halo"" around injection site the following day. She believes it to be a localized reaction, states concerns with timing of next COVID vaccine. Referred to contact physician.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/03/2021,5.0,PVT,,,,,,"['Erythema', 'Injection site erythema', 'Local reaction', 'Urticaria']",UNK,MODERNA,IM 921597,TX,26.0,F,Welp and swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,no,"['Swelling', 'Urticaria']",1,MODERNA,IM 921598,NY,19.0,F,"Tingling in throat after injection, but subsided after 5 minutes. About an hour after injection, I checked injection site and found a half-dollar bill sized red welt that was hot to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,10MG of over the counter ZYRTEC @9am that morning,NONE,NONE,,NONE,"['Injection site erythema', 'Injection site reaction', 'Injection site warmth', 'Pharyngeal paraesthesia', 'Urticaria']",1,PFIZER\BIONTECH,SYR 921599,TN,52.0,F,"Pt. c/o pain and redness at vaccine site on 12/23/2020 around 7 pm.. also c/o headache. Took Benadryl 25 mg PO q 4-6 hours and Ibuprofen and Aleve. Pt. states redness was worse the next morning, 12/24/20, and noticed significant swelling at site. Pt. states symptoms improved by 12/25/20. Seven days later, patient states noticed swelling and itching at the vaccine site again. Also states started having bruising and streaking. Took Benadryl 25 mg PO q 4-6 hours, Ibuprofen and Aleve. Swelling has improved, but bruising is still present.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,PUB,"Keppra 1500 mg PO BID, Vit. B, Vitamin B12, Vit. C, Vit. D3, Zinc - PO daily",None,Chronic seizures,,None,"['Headache', 'Injection site erythema', 'Injection site pruritus', 'Vaccination site bruising', 'Vaccination site pain', 'Vaccination site streaking', 'Vaccination site swelling']",1,MODERNA,IM 921600,OH,88.0,F,Significantly increased confusion,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/03/2021,3.0,UNK,,,"Type 2 diabetes, Hypertension, arthritis, edema, polyosteoarthritis, scoliosis",,"Oxaprozin, Penicillin",['Confusional state'],UNK,MODERNA,SYR 921601,NJ,29.0,F,Had COVID vaccine yesterday. Felt Fatigued yesterday afternoon. Felt feverish during the night. At 7:00am this am Temp 100.3. Took 2 extra strength Tylenol At 11:00 temp 98.9 At 2:15 temp 100.8 Took 2 Tylenol extra strength Tylenol. At 3:00 pm temp 101.8.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Levothyroxine 150 mcg qd,Denies,hypothyroidism,,NKA,"['Fatigue', 'Pyrexia']",1,MODERNA,IM 921602,TX,33.0,F,"Once I got home that evening after getting vaccine on my left arm, I was experiencing some pain on my limbs and injection site, I was a little off , fatigued, mild hallucinations on that night only and low appetite.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,UNK,None,None to my knowledge.,None,,None that I know of.,"['Decreased appetite', 'Fatigue', 'Feeling abnormal', 'Hallucination', 'Injection site pain', 'Pain in extremity']",1,MODERNA,IM 921603,NE,66.0,M,"DEVELOPED RED RASH ON UPPER RIGHT CHEST (17CMX13CM), WARM TO TOUCH AND ITCHES. BY NEXT MORNING COLOR HAD FADED AND RASH WAS NOT AS ITCHY.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,SEN,,,,,,"['Rash', 'Rash erythematous', 'Rash pruritic', 'Skin warm']",1,PFIZER\BIONTECH,IM 921604,,53.0,F,"Headache, nausea, light-headed. Mostly resolved after 30 minutes of observation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,UNK,,,,,,"['Dizziness', 'Headache', 'Nausea']",1,PFIZER\BIONTECH,IM 921605,TX,23.0,F,"Headache developed after vaccine was administered Fever: 102.1 Fatigue: spent the whole day away Felt like I had no energy Site is red , tender to touch, and swollen",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,UNK,,,"IGG Deficiency, Severe Eosinophilic Asthma, iron deficiency anemia, high blood pressure, tachycardia, arthritis, severe pancreatic enzyme deficiency, fat soluble vitamin deficiency, and adrenal insufficiency",,"Tegaderm, adhesive tape, mangoes, and penicillin antibiotics","['Asthenia', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Pyrexia']",1,MODERNA, 921606,TX,40.0,M,"Fever, arm pain and stiffness, nausea, states ""I felt like I was in a fog"", chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,Tylenol for fever,Flu vaccine 12/10/20,,,Peanuts and Clindamycin,"['Chills', 'Feeling abnormal', 'Inappropriate schedule of product administration', 'Musculoskeletal stiffness', 'Nausea', 'Pain in extremity', 'Pyrexia']",,MODERNA,IM 921607,SC,39.0,F,"Patient works at County EMS. Shot given at 9AM and at approximately 915AM an EMT came and told me she broke out in urticaria. She denied having this reaction to a vaccine before, but has had reactions to unknown substances a few times on the scene of calls and had to receive EPI and Benadryl. At 9:20 AM EMS personnel gave her one shot of Epi (with Epi Pen) and a dose of Benadryl. At 9:35 AM pt states she felt better. At 10 AM I checked on her one more time and she said she felt fine. She did ask for the ingredients in the vaccine. Showed her where to find on her paperwork. Advised she may want to get MD clearance before taking shot #2.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,none on file,"unknown, denied recent illness",unknown,,none per conversation with pt,['Urticaria'],1,PFIZER\BIONTECH,IM 921608,IL,79.0,M,patient received two Pfizer vaccines in the left arm,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PHM,,,,,,['Extra dose administered'],2,PFIZER\BIONTECH,IM 921609,IL,36.0,F,Dizziness and vomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,Paroxetene and Trazodone,,,,NKA,"['Dizziness', 'Vomiting']",1,MODERNA,IM 921610,NJ,36.0,F,Complained of feeling lightheaded and dizzy,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,,,,,,['Dizziness'],1,PFIZER\BIONTECH,SYR 921611,WI,25.0,F,"Severe arm soreness, redness and lump at site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,Sertraline 100mg Topamax 50 mg Multivitamin,none,migraines,,Imitrex & Compazine,"['Injection site erythema', 'Injection site mass', 'Injection site pain', 'Pain in extremity']",1,MODERNA,IM 921612,TX,65.0,M,"Fever, Night Sweats, Chills, Soreness in all limbs, Fatigue,Tiredness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,"High Blood Pressure, Blood Thinner, Cholesterol",No,"High Blood Pressure, Blood Thinner, Cholesterol",,No,"['Chills', 'Fatigue', 'Night sweats', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 921613,WA,83.0,F,"swelling at injection site, some redness, some headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,OTH,"Lisinopril, Omeprazole, CHLORD/CLIDI, multi-vitamin",,Diverticulitis,,,"['Headache', 'Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 921614,FL,56.0,F,Woke next day with severe headache and nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,"Cymbalta, Zyrtec",None,,,None,"['Headache', 'Nausea']",1,MODERNA,IM 921615,PA,38.0,F,"Within first 5 mins - Sudden onset of warm sensation (similar to the feeling of IV contrast administration), flushed feeling, pale, near syncope followed by nausea and dry heaving. Lasted 30 mins. Felt fatigued and mild headache for next 24-48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"Lexapro 5mg daily, Xyzal 5 mg daily, Trelegy daily, and multivitamin.",None,"Chronic Urticaria, Asthma, GERD, Lupus anticoagulant, Obesity",,"Penicillin, Ceclor, seasonal","['Fatigue', 'Feeling hot', 'Flushing', 'Headache', 'Nausea', 'Pallor', 'Presyncope', 'Retching']",1,PFIZER\BIONTECH,IM 921616,,42.0,M,"Had fever of 102 with severe chills. Also had heacache, fatigue, and pain at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PUB,"mutli-vitamins, claritin",none,none,,tree nut allergies,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pyrexia']",1,MODERNA,IM 921617,PA,58.0,F,"Dizziness, Light headed, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,PVT,,High Blood Pressure,,,Penicillin,"['Dizziness', 'Nausea']",UNK,PFIZER\BIONTECH,IM 921618,PA,49.0,F,"Headache, dizziness, numbness/soreness in the left side of my face-cheek, eye, mouth, and tongue areas. Affects similar to receiving a Novocain shot. No treatment, went away on its own Lasted four hours-was closely monitored",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,"Omega Oil, Vitamin C, Apple Cider Vinegar Supplement",Upper respiratory infection 2 weeks prior to vaccination,Immunocompromised due to low IG numbers.,,Levaquin,"['Dizziness', 'Eye pain', 'Facial pain', 'Glossodynia', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia eye', 'Hypoaesthesia oral', 'Oral pain']",1,PFIZER\BIONTECH,IM 921619,NE,37.0,F,"DAY AFTER VACCINATION, DEVELOPED SLIGHT MUSCLE ACHES IN UPPER BACK AND LOW GRAD FEVER (99.6) FOR A FEW HOURS. RESOLVED BY 1/2/21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,SEN,,,,,,"['Back pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 921620,NY,53.0,F,"Shortness of breath, fever, body aches, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,Chosterol,no,High Cholesterol,,no,"['Chills', 'Dyspnoea', 'Pain', 'Pyrexia']",1,MODERNA,IM 921621,MI,24.0,F,"A day after the vaccine, the patient experienced joint pain and muscle aches, and both eyes started to swell with redness in both eyes. This continued for 5 days post-vaccination. Eyes were not dry, but just swollen. Pt took Tylenol and put compresses on her eyes at home. Symptoms are now resolving. Patient instructed to follow up with her PCP should symptoms continue or worsen. Patient said she was just reporting so we'd be aware but felt she was getting better.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,PVT,"insulin - Humalog, novalog",,Type 2 diabetes,,,"['Arthralgia', 'Eye swelling', 'Myalgia', 'Ocular hyperaemia']",1,PFIZER\BIONTECH,IM 921622,MA,40.0,F,"One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in size)-same side as injection. It was painful and partially mobile. No other symptoms other than those of headache a few days prior mentioned below. I went to urgent care on 12/29 where CXR and soft tissue ultrasound were ordered. CXR normal. US 12/30 showed cluster of lymph nodes in that area. Lump appears to be smaller this week and not painful. Also, I developed a severe migraine on 12/26 (5d post vaccine). So severe that it was debilitating which is unusual for me. It lasted approximately 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/28/2020,7.0,PVT,Tri Sprintec Prn klonopin Prn Percocet Prn flexeril Prn vistaril,N/a,Migraines,,Sulfa and cipro,"['Asthenia', 'Chest X-ray normal', 'Condition aggravated', 'Headache', 'Induration', 'Lymphadenopathy', 'Mass', 'Migraine', 'Pain', 'Ultrasound scan abnormal']",1,PFIZER\BIONTECH,IM 921624,NJ,30.0,F,Light headed,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 921625,CA,,F,"Tuesday 12/22/20, right side of face was itchy and swollen, both top of eyelids red and itchy, took bendryl and it relieved symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/23/2020,2.0,PVT,,,,,,"['Eyelid rash', 'Eyelids pruritus', 'Pruritus', 'Swelling face']",1,PFIZER\BIONTECH,IM 921626,OH,54.0,F,"At 11:30 PM on 1/4/2021 I awoke to severe headache, joint, and body aches. Broke our into a cold sweat and then chills. Became nauseous and extremely dizzy. Was forced to call off from work. Contacted the occupational health doctor at the facility where I received the vaccine (my employer) and reported my reaction. Was advised to rest, take pain reliever and report back if symptoms were not gone after 2 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Lisinopril Cardizem Maxide Levothyroxine Divigel Multi vitamin Calcium with vitamin D Glucosamine,M�ni�re?s disease,HTN Palpitations Hypothyroidism Menopause Osteopenia,,None,"['Arthralgia', 'Dizziness', 'Headache', 'Impaired work ability', 'Nausea', 'Pain']",1,MODERNA, 921627,OH,55.0,F,"Reported continuous Right Arm joint pain (shoulder, elbow, wrist) on the evening of 1/1/21. Pain has not worsened or got any better as of 1/5/21. Taking Motrin seems to help some with the pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,trental and bentyl which are regular medications taken at 1600 on 12/31/20.,migraines,"migraines, claudication",,"Morphine, Toradol","['Arthralgia', 'Injection site joint pain']",1,PFIZER\BIONTECH,IM 921628,CA,53.0,F,"The next day 12/18 felt weak, fatigue and had to rest in between my activities. I exp headaches for 2 days and on 12/20 feeling 100 ft walk was tired. Then on 12/21 started my exp body ache lasted 2 days. I spoke with my PCP and had a appt on 12/28. On 12/31 it felt as of my symptoms was subsiding. I started feeling better on 1/2/21. I missed 6 days of work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,No,Thyroid problems,Thyroid problems,,"Sulfur, Penicillin","['Asthenia', 'Chest X-ray', 'Fatigue', 'Headache', 'Impaired work ability', 'Laboratory test', 'Pain', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 921629,AL,62.0,F,"2 days post injection, pain at the site of injection. Now (as of 1/5/21) - the site is red, raised and very itchy. Has taken Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,No medications,None,None,,Ibuprofen Percocet Iodine based contrast,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 921631,MI,83.0,F,"""Patient with seizure this am during 1 assist transfer, resident passed out, lowered to shower chair next resident with incontinent episode and was sent to Emergency Department emergently and currently under evaluation with possible admission. """,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/05/2021,2.0,SEN,aspirin 81mg q week carb-levo ER 50-200 q day fludrocortisone .1mg q day fluticasone 50mcg spray q day linzess 145mcg cap q day mag ox 400 mg q day remeron 45 mg tab q day pravastatin sodium 20 mg q day Zoloft 100 mg q day Flomax .4mg q day,"She is normally alert, has had a recent change in mentation, increased confusion, increased lethargy worsening since admission 8/18/2020. numbness/tingling to hands and feet.","Parkinsons, hyperlipidemia, HTN, hip replacement, depression, bladder retention, dysphasia oral phase",,NKA,"['Incontinence', 'Laboratory test', 'Loss of consciousness', 'Seizure']",1,MODERNA,IM 921632,NE,56.0,F,"DEVELOPED SORES IN MOUTH AND FEELS LIKE DOWN HER THROAT. AS OF 1/5/21, CONDITION HAS IMPROVED, BUT NOT RESOLVED.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,SEN,,,,,,"['Stomatitis', 'Throat irritation']",1,PFIZER\BIONTECH,IM 921633,NY,26.0,F,"The night after the covid vaccine, the patient started experiencing left-side facial numbness and tingling of the V2 and V3. Patient also started experiencing ear pain. Patient also had uncontrollable drooling and dry eye. The next day, the patient went to work and there the adverse events started worsening. Patient went to the ER and did a full workup. CT scan to rule out stroke and full blood work. As per the neurologist (MD), patient is developing mild Bell's Palsy. No course of treatment was given.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,"Doxycycline 20 mg bid, Vascepa 2 caps bid, YAZ, Spironolactone, Folic acid 1 mg, Fluoxetine 40 mg daily, GNC women's multivitamin",None,None,,Acetaminophen and daptomycin,"['Blood test', 'Computerised tomogram', 'Drooling', 'Dry eye', 'Ear pain', 'Facial paralysis', 'Hypoaesthesia', 'Neurological examination abnormal', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 921635,MI,70.0,F,Patient was light headed after returning to her vehicle post vaccination. Then she started to have heart palpitations. EMS called an ambulance and put her on a heart monitor. She showed mild Atrial Fibrillation. EMS wanted client to go to the ER but she refused. No other symptoms or treatment that I am aware of.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PUB,,,,,,"['Atrial fibrillation', 'Dizziness', 'Palpitations']",1,PFIZER\BIONTECH,IM 921636,AL,28.0,F,"Fever (max of 101.8), chills, headache, fatigue, injection site reaction (swelling, redness, skin sensitivity)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,"Loestrin, Methocarbamol, ibuprofen",none,Ehlers-Danlos,,Penicillin,"['Chills', 'Fatigue', 'Headache', 'Hyperaesthesia', 'Injection site erythema', 'Injection site reaction', 'Injection site swelling', 'Pyrexia']",1,MODERNA,IM 921637,NJ,39.0,M,Nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,,['Nausea'],1,PFIZER\BIONTECH,IM 921638,AZ,34.0,F,Swollen lymph node under Left arm and in arm pit. Painful to have arm down.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PUB,Micronor- birth control Prenatal vitamins,None,None,,None,"['Axillary pain', 'Lymphadenopathy']",1,MODERNA,IM 921639,TX,42.0,F,Employee received the COVID vaccine on 12/23. She developed abdominal pain on 12/29. Was seen in the ED on 12/30 for an emergency appendectomy. Employee states that the CDC website lists appendectomy as the most common severe adverse event in the COVID vaccine group. Which was numerically higher than in the placebo group.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/29/2020,6.0,PVT,unknown,No,No,,NKA,"['Abdominal pain', 'Appendicectomy']",1,PFIZER\BIONTECH,IM 921640,NE,94.0,F,1:45 PM flushing with headache Blood Pressure: 120/64; Pulse 80; Pulse Ox: 98% 1:55 PM Blood Pressure 170/90; Pulse 84: Pulse Ox: 98% Resident up and walking 2:05 PM Slight headache Blood Pressure 130-70; Pulse 78; Pulse Ox: 98%,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,unknown - Independent Living,unknown - Independent Living,unknown - Independent Living,,unknown - Independent Living,"['Flushing', 'Headache']",UNK,PFIZER\BIONTECH,IM 921641,NY,17.0,F,"Administered first dose of COVID19 vaccine at 1:29pm on 1/4/21. At approximately 11:00pm resident exhibited acute respiratory decompensation with very limited air entry and hypoxemia. Patient received Benadryl, steroids, epinephrine, and Duoneb without improvement. Resident was referred to the emergency room and found to be COVID positive. No fever or rash were reported.",Not Reported,,Yes,Yes,,Not Reported,U,01/04/2021,01/04/2021,0.0,SEN,acetaminophen 160 mg/5 mL (5 mL) oral solution albuterol sulfate 2.5 mg/3 mL (0.083 %) solution for nebulization budesonide 0.5 mg/2 mL suspension for nebulization Certavite-Antioxidant 18 mg-400 mcg tablet ClearLax 17 gram/dose oral powder,Right lung atelectasis/infiltrate with right mediastinal shift on chest x-ray (12/25) that was treated with steroids and antibiotics,Chronic respiratory Failure Dependence on mechanical ventilation Seizure disorder Spastic quadriplegic cerebral palsy Encephalopathy,,NKA,"['Acute respiratory failure', 'COVID-19', 'Hypoxia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 921642,NE,35.0,M,Lympadenopathy right above left clavicle. Symptoms started on 1/2/21 and have continued. Nothing has been used to treat the symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/02/2021,10.0,WRK,"Atorvastastin , flonase, Zyrtec, aspirin",none,stroke,,augmentin,['Lymphadenopathy'],UNK,MODERNA,IM 921643,WA,55.0,F,"called to observation area 1120 for report of mottled skin. bp 150/80, p 90. noticed 5 min after vaccine new, firm, raised area right wrist 1/2 x 1/4 x 1/4. skin arms, chest, face flushed. by 1130 skin redness of chest decreased, by 1135 color at baseline - raised area 1/4x 1/4x/1/8. 1140 return to work. had talked w/ provider prior to vaccine and ok to give.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,"Rituxan - every 6 months - last 8/2020 Lupron injection q 3 months - last 12/18/20 HCTZ for BP Synthroid Nifedipine multi vits, vit d, supplements",none,vasculitis,,none known,"['Erythema', 'Flushing', 'Induration', 'Livedo reticularis']",1,MODERNA,IM 921644,MN,42.0,F,Patient had first dose on 12/18/2020. On 12/30/2020 received second dose. On Registration form he checked that he had never been vaccinated with COVID before and received second dose too close to first. (12 days apart).,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,['Inappropriate schedule of product administration'],2,PFIZER\BIONTECH,IM 921645,NE,57.0,F,"DEVELOPED SORENESS IN ARM, EXTREME FATIGUE, AND BODY ACHES.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,,"['Fatigue', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 921646,,40.0,M,syncope 4 hours after chills 2-5 hours after body aches off and on for 7 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,mirtazipine,none,none,,none,"['Chills', 'Pain', 'Syncope']",UNK,MODERNA, 921647,WY,52.0,F,"Patient described leg heaviness the following day (12/18/20), then onset on 12/19/20 of blisters to neck, chest and abdomen, chest pain, and elevated blood pressure. Patient states she is already on cardiac medications so she took an additional dose for her blood pressure and monitored herself closely.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/19/2020,2.0,PVT,Unknown,Unknown,heart condition,,Unknown,"['Blister', 'Blood pressure increased', 'Chest pain', 'Limb discomfort']",1,PFIZER\BIONTECH,IM 921648,MA,39.0,M,"allergic reaction, diffuse rash, no utricaria; no respiratory symptoms. Rash developed 2 days after vaccination. Treated with antihystamines.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,UNK,,,,,,"['Hypersensitivity', 'Rash']",1,PFIZER\BIONTECH,IM 921649,,46.0,M,"Felt light headed, dizzy Stated he felt like he had Epstein barr",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 921650,FL,32.0,F,"I was vaccinated through a Covid 19 vaccine clinic at work. The injection was given in my left arm. However, I believe the nurse that gave the vaccine may have given it subcutaneously and not IM. The injection was given in the dorsal part of my deltoid muscle. A few hours after vaccination, I had some redness and swelling where the injection was given, about 2 inches in diameter and a large bruise began to form. My arm was very sore for about 3 days. The 2 inch spot stayed raised, but the redness reduced to pink over the next two days and then it was gone. The bruise almost completely was faded away by 1/4/21. This morning (1/5/21) when I woke up, I noticed the 2 inch spot on my arm came back, it was bright red, hot to the touch and slightly itchy. My arm is also a little sore today I contacted occupational health at my work and they notated the reaction in my chart and told me to write a report with VAERS. Currently I am apply cool compresses a few times a day to the site and applied a small amount of hydrocortisone cream (1%) to the reddened area.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/05/2021,8.0,WRK,None,None,None,,Sulfa allergy,"['Injection site bruising', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Wrong technique in product usage process']",1,MODERNA,SYR 921651,VA,62.0,F,"Persistent vomiting from 3am to about noon on Monday. Fever of 38.4 ' C. Headache, chills, fatigue. Slept most of the day. Took acetaminophen when able to drink. Drank ginger tea and ate dry toast in the evening. Tuesday, HA controlled with Acetaminophen and Ibuprofen. Able to eat and increase fluids. Consulted with my PCP who suggested I enter my information. Feeling stronger as time passes. I believe another nights sleep will help.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,PVT,Acetaminophen,None,None,,Bactrim Sulpha,"['Chills', 'Fatigue', 'Headache', 'Hypersomnia', 'Hypophagia', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 921653,NJ,57.0,F,"Dizziness, Chills and Pale",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Chills', 'Dizziness', 'Pallor']",1,PFIZER\BIONTECH,IM 921654,CA,50.0,M,"Body Chills, Headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,UNK,no,"Yes, covid positive from 11/26/2020 til about 12/06/2020",no,,no,"['Chills', 'Headache']",UNK,MODERNA,SYR 921655,GA,37.0,F,"Severe muscle/joint aches beginning day of vaccine until three days later. 102 fever and severe chills for 36 hours beginning night of injection. Severely swollen lymph nodes under injection arm for four days. Splotchy, hot red spots under injection site three days after injection. Swollen, extremely sore area around injection site for four days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,Otezla Citalopram,none,Granuloma Annulare,,none,"['Arthralgia', 'Chills', 'Injection site pain', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Lymphadenopathy', 'Myalgia', 'Pyrexia', 'Rash macular']",1,MODERNA,SYR 921656,PA,35.0,F,"wave of dizziness, weakness and hot feeling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,,,,,NKA,"['Asthenia', 'Dizziness', 'Feeling hot']",UNK,MODERNA,IM 921657,TX,41.0,F,"On the 21st in the morning I had alternating chills and subjective fever. I did not really have fever and kept monitoring it during the day. The next day I kept with the subjective fever and the chills, went to the urgent care the next day and was tested for covid, flu and strep and it came positive for strep. I was prescribed an antibiotic and stayed home the next day since I still did not feel well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/21/2020,3.0,PVT,None,No,No,,Unknown,"['Chills', 'Influenza virus test', 'Malaise', 'Pyrexia', 'SARS-CoV-2 test', 'Streptococcus test positive']",1,PFIZER\BIONTECH,SYR 921658,CA,42.0,F,arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills no fever exhausted no appetite arm pain is 60% better today no redness at injection site mild swelling at injection site mentally foggy weak vision,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,Missing small and large intestine,,,"['Asthenia', 'Chills', 'Decreased appetite', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Headache', 'Injection site swelling', 'Mobility decreased', 'Nausea', 'Pain in extremity', 'Visual impairment']",1,PFIZER\BIONTECH,SYR 921659,NJ,33.0,F,"Extreme fatigue, loss of appetite, weakness, irritable, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,Birth control Multivitamin Probiotic,None,History of anxiety/depression,,PCN Wellbutrin,"['Asthenia', 'Decreased appetite', 'Fatigue', 'Irritability', 'Pyrexia']",1,MODERNA,IM 921660,IN,57.0,M,"Scratchy throat, Lump in lip. Throat was swollen and could not swallow. Benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,Baby Aspirin,None,None,,Papaya,"['Dysphagia', 'Mass', 'Pharyngeal swelling', 'Throat irritation']",1,PFIZER\BIONTECH,IM 921661,MO,23.0,F,"After receiving the vaccine I had some left arm soreness. The pain increased throughout the day. About 12 hours after receiving the vaccine the pain in my left arm became severe. I experienced nausea, fever of 100, body aches, chills, headache, diarrhea, chest pain, and left hand numbness throughout the night and into the day following",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PUB,,,,,Citalopram,"['Chest pain', 'Chills', 'Diarrhoea', 'Headache', 'Hypoaesthesia', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 921662,CA,27.0,M,"Patient presented to receive COVID-19 vaccine (Pfizer) at approximately 1621. Patient waited 15 minutes when asking to leave was asked if she had any symptoms, patient reported headache. NP asked patient to lay down in stretcher and took repeat vitals which showed elevated BP. Patient reported feeling clammy had palpitations. NP made decision to call EMS. EMS arrived and transported patient to ED at 1735.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,UNK,,,,,,"['Blood pressure increased', 'Cold sweat', 'Headache', 'Palpitations']",1,PFIZER\BIONTECH,IM 921664,NJ,59.0,F,Patient states to feeling nauseated and had tingling in the arm and hand. Patient was sent to the ED to rule out TIA but left before being evaluated. Patient states symptoms have resolved and did not want to be seen by ED physician. Patient was educated on returning back to ED with any new concerns.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Nausea', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 921665,KY,49.0,F,PATIENT REPORTED FACE AND TONGUE TINGLING. DENIED ANY PATIENT REPORTED SHORTNESS OF BREATH AND TONGUE/FACE TINGLING WITHIN 15 MIN OF COVID 19 VACCINATION IM. OBSERVED BY RN. dR ON SITE AND INFORMED. NO FACIAL SWELLING OR DROOP. BP TAKEN 167/108.BENADRYL 25MG LIQUID GIVEN ORALLY. PATIENT SAID SHE FELT BETTER AFTER BENADRYL. OBSERVED ANOTHER 30 MINUTES. FOLLOW UP BP WAS 140/91 AND HR WAS 72. TINGLING RESOLVED. Reported taking a steroid dose once at home from prednisone that was already prescribed to her.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"Amolodipine Besylate, Amoxicillin/Potassium Clav, Butalb/Acetaminophen/Caffeine, Clopidogrel Bisulfate, Diazepam, Fluconazole, Advil Cold & Sinus, Levothyroxine Sodium, Pramipexole Di-Hcl, Prednisone",Sinus Infection,"GI immotility, migraines, hypothyroid, TIA, Celiac stents, HTN",,"aspirin, atorvastatin, esomeprazole, morphine, simvastatin, silk tape","['Paraesthesia', 'Paraesthesia oral']",1,MODERNA,IM 921666,NY,77.0,M,"gross hematuria, painless, urinary frequency, urgency, started 6 am upon awakening 4.75 days following vaccine administration",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/05/2021,5.0,OTH,"invokamet, bystolic, aspirin, omeprazole, tamsulosin, amlodipine, atorvastatin, vitamin D3, eye drops for glaucoma",Otitis media,"lymphoma, in remission. Not on medication or chemotherapy; diabetes; hypertension; hyperlipidemia; BPH; glaucoma",,NKDA. No food or environmental allergies.,"['Haematuria', 'Micturition urgency', 'Pollakiuria']",1,MODERNA,IM 921667,OH,39.0,F,"LTCF Pfizer Vaccine clinic conducted 12/29/2020 Vaccine lead received a call indicating that a staff member deceased somewhere between 1/3/2021 and 1/4/2021. Cause of death is unknown, and an autopsy is being performed.",Yes,01/03/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,SEN,,,,,,"['Autopsy', 'Death']",1,PFIZER\BIONTECH,IM 921668,NV,45.0,F,"Pouring sweat, hives, light headedness and dizziness and tremors, weakness, burning, itching of all skin, blurred vision",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,"Gabapentin, Lunesta meloxicam, prednisone, Strattera spironolactone Lisinopril atorvastatin",None,"Difficulty sleeping, back pain, high blood pressure, multiple site joint pain, ear tube dysfunction,",,"Amitriptyline, aspirin, Lamotrigine, Penicillin, sulfur drugs, Tetanus toxin, Trazodone, Maogo, Aspartame","['Asthenia', 'Burning sensation', 'Dizziness', 'Hyperhidrosis', 'Pruritus', 'Tremor', 'Urticaria', 'Vision blurred']",UNK,MODERNA,IM 921669,IA,62.0,M,"Congestion like a head cold, raspy throat, nausea, headache, low grade fever 100. -Tylenol taken for fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,SEN,"Losartan, Simvastatin",,"High blood sugar, high blood pressure, high cholesterol",,"Penicillin and sulfa drugs, codeine, coconut","['Dysphonia', 'Headache', 'Nasopharyngitis', 'Nausea', 'Pyrexia', 'Respiratory tract congestion']",1,MODERNA,IM 921670,FL,,F,"soreness at injection site, fatigue, flulike symptoms initially. On 1/5 she developed "" pressure"" in her lower abdomen and lower back",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,PVT,"lisinopril, metformin, crestor, activell",none,"elevated cholesterol, HTN, NIDDM",,Levaquin,"['Abdominal discomfort', 'Fatigue', 'Influenza like illness', 'Injection site pain', 'Musculoskeletal discomfort']",1,PFIZER\BIONTECH,IM 921671,MI,76.0,F,Numbness on right side of face,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,WRK,,"Migraine, botox injections on R side of face",,,,['Hypoaesthesia'],UNK,PFIZER\BIONTECH,IM 921672,CO,42.0,F,MODERNA COVID-19 Vaccine EUA - Received vaccine on 12/26 and I still have a red mark on my arm where I received the vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/27/2020,1.0,PVT,"Wellbutrin, OC vitamins",None,Obesity,,None,['Injection site erythema'],UNK,MODERNA,SYR 921673,PA,57.0,M,I have developed vertigo. It began on the morning of December 30 and was transient. It now is more persistent (but worse in the morning) and associated with nausea. It is positional as changing positions quickly make it worse.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/30/2020,9.0,PVT,None,None,None,,None,"['Nausea', 'Vertigo positional']",1,PFIZER\BIONTECH,IM 921674,MA,52.0,F,"allergic reaction; experienced flushed skin, lightheadedness, tingling, SOB. Observed in ED and released when symptoms resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,PVT,,,,,,"['Dizziness', 'Dyspnoea', 'Flushing', 'Hypersensitivity', 'Paraesthesia']",1,MODERNA,IM 921675,PA,34.0,F,"Itchy, raised rash/welts at injection site. The reaction occurred 8 days post injection. The raised area was circular with clear borders.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/05/2021,7.0,PVT,,,,,,"['Injection site reaction', 'Rash papular', 'Rash pruritic', 'Urticaria']",1,MODERNA,IM 921676,,56.0,M,"Patient is a 56 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination. � He denied any history of previous adverse reactions to vaccines. � He was given the Moderna vaccination in the left deltoid muscle. � During his 15 minute waiting period after the injection, the patient began to experience nausea and feeling hot. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. � This provider was notified of patient reaction and he was then assessed in the emergency bay area. � Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting. � Pt drank water and got to feeling better within a few minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,,,,,,"['Feeling hot', 'Nausea']",UNK,MODERNA,IM 921677,CA,42.0,F,"About 20-30 after injection it became a bit difficult to swallow. Throat felt thicker; heart felt like it was racing. Shivering and Blood pressure was up a little. 14:19 Benadryl 25 mg administered. 14:30 BP 164/92, P-76 R-16 O2 100% Discharged back to work at 16:15.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,"""scratchy symptoms"" with Kiwi. No allergy to medications or vaccines.","['Blood pressure increased', 'Chills', 'Dysphagia', 'Palpitations', 'Throat tightness']",1,PFIZER\BIONTECH,IM 921678,TX,28.0,M,"Myalgia, HA, nausea, joint pain, and pain and redness at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,MIL,Denies,COVID diagnosis on 12/21/2020,Denies,,Sulfa Drugs,"['Arthralgia', 'Headache', 'Injection site erythema', 'Injection site pain', 'Myalgia', 'Nausea']",1,PFIZER\BIONTECH,IM 921679,,80.0,F,"Patient reported that approximately 2.5-3 weeks after receving flu shot, she began experiencing numbness that began in her fingers/toes/feet, and progressed up to her knees. She also reported double vision. She called 911 and was taken to the ED, where a neurologist ordered an MRI and confirmed Guillain-Barre syndrome. Patient spent 11 days in ICU, and was then transitioned to progressive care. After being admitted, she experienced progressive numbness, including in head and face, and inability to walk. She reported that she received 7 doses of IVIG while in ICU. She reported that since being discharged, she has been able to walk with a walker and is taking some steps on her own. She is still having numbness as of 12/20/20, for which she is taking gabapentin and methocarbamol. She also completed a taper of prednisolone eye drops for her ohpthalmic symptoms. She was also given home health care exercises to complete daily.",Not Reported,,Not Reported,Yes,11.0,Not Reported,,10/28/2020,11/14/2020,17.0,PHM,,,,,,"['Diplopia', 'Gait inability', 'Guillain-Barre syndrome', 'Hypoaesthesia', 'Immunoglobulin therapy', 'Intensive care', 'Magnetic resonance imaging abnormal', 'Walking aid user']",UNK,SANOFI PASTEUR,IM 921680,NC,60.0,F,Chills and fatigue were noticed in the morning after receiving the vaccine (first dose) the day before. Time would be approximately 20 hours after receiving the shot.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/01/2021,01/05/2021,4.0,UNK,,,,,,"['Chills', 'Fatigue']",UNK,MODERNA,IM 921681,TN,46.0,F,"Began with headache in late evening on the 4th. Woke up with extreme nausea, headache, fatigue. Has continued through the day of 5th.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,PUB,Synthroid 100 mcg Ozempic .5mg 2xmonth,none known,Hashimoto's,,none known,"['Fatigue', 'Headache', 'Nausea']",1,PFIZER\BIONTECH,SYR 921682,NJ,58.0,F,"Dizzyness (I felt like I was drunk or drugged) starting about 1 minute after vaccine. I left my car there and got a ride home. Now, 2 hours later, my head still feels cloudy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,"mercaptopurine, mesalamine, Elmiron, rosuvastatin, hydroxyzine, bupropion HCL ER, valacyclovir, vitamin D",,"Ulcerative colitis, interstitial cystitis, hyperlipidemia, depression",,,"['Dizziness', 'Feeling abnormal']",1,MODERNA,IM 921683,WI,37.0,F,"Within a day of receiving the vaccine, she had a hard and reddened area at site of injection. This resolved in a few days. When she woke up 8 days after the vaccine, the injection site was again hard, itchy, erythematous and warm to the touch. Feels over the course of the day this is worsening.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,"amytriptiline, sprinolactone, rizatriptam, aleve PRN, Zyrtec daily, melatonin, IUD, completed accutane 3 weeks prior",none,"allergies, asthma, migraines",,"seasonal allergies, tiaconozole","['Injection site erythema', 'Injection site induration', 'Injection site pruritus']",1,MODERNA,IM 921684,CA,60.0,F,Rashes in torso area and minor dry cough. Improved after taking Benadryl.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/24/2020,1.0,PVT,,,,,Sulfa drugs,"['Cough', 'Rash']",1,MODERNA,IM 921685,WI,46.0,F,Muscle aches followed by severe abdominal cramping,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,"cetirizine, cholecalciferol, fluticasone, hydrichlorothiaxide, iburprofen, pantoprazole",None,"complex ovarian cyst, HTN, GERD, hyperlipidemia, uterine leiomyoma",,None,"['Abdominal pain', 'Myalgia']",1,PFIZER\BIONTECH,IM 921686,CO,52.0,F,"Day 6 post injection continue to have slight pain and swelling at injection site since administration, today noticed it to be superficially itchy. Last night at 2300 I had taken a benadryl, and the current time is 1400 and the itchiness I suspect is due to the benadryl wearing off.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Wellbutrin SR, zyrtec daily",none,hyperallergic,,environmental only,"['Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 921687,TX,28.0,M,"Myalgia, HA, Nausea, Joint Pain, and pain and swelling at the injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,MIL,Denies,COVID diagnosis on 12/21/20,Denies,,Sulfa drugs,"['Arthralgia', 'Headache', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Nausea']",1,PFIZER\BIONTECH,IM 921688,IA,51.0,F,"Fever (101), chills, severe headache, body aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,UNK,Celexa 40 mg Birth control pill,None,Anxiety,,Penicillin,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 921689,GA,54.0,F,"PM of 12/31/2020-shoulder blade, down left arm and 4th and 5th finger on left hand hurting. About bedtime on 12/31/2020, left arm pain. sit note, no redness, chills , headache, myalgias and joint pain. 1/1/2021 AM temperature got over 103 degrees and weakness. ok during the day of 1/1/2021. About 7 PM on 1/1/2021 temperature went up to 102 degrees. She did sweat during the night of 1/1/2021. 1/2/2021- temperature stayed about 99-100 and she felt ""shivery"". Up until 1/4/2021, she had extreme tenderness and warmth to left arm. No redness. Better today, 1/5/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,,,,,no known,"['Arthralgia', 'Asthenia', 'Body temperature increased', 'Chills', 'Night sweats', 'Pain in extremity', 'Skin warm', 'Tenderness']",1,MODERNA,IM 921690,CT,37.0,F,"had the expected local reaction of soreness, redness, and swelling the day following vaccination, which completely resolved within a day or two. then developed another similar local reaction at the injection site exactly 1 week later (swelling, redness), which resolved within 48hr or so",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/31/2020,7.0,PVT,prenatal vitamins,none,obesity,,sulfa allergy: unknown reaction,"['Erythema', 'Injection site erythema', 'Injection site swelling', 'Pain', 'Swelling']",1,MODERNA,IM 921691,MI,46.0,M,"No immediate reaction within 15 minutes of injection. Increasing injection site pain throughout the day with mild chills and nausea starting around 7:00 pm (Approx 11 hrs after injection). Chills steadily intensified, with fever beginning, became severe over the next 2-3 hours, and persisted throughout the night. Along with the fever/chills & nausea, there was also moderate muscle/joint pain (mainly neck and back), moderate to severe fatigue and weakness, weird freaky dreams, restlessness, and moderate headache. Symptoms started to relent around 6:00 am the morning after injection, however fatigue/weakness, nausea, and mild fever/chills have persisted throughout the day with minimal improvement.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,None,None,None,"Injection site pain, very mild fever & muscle/joint pain with 1st covid vaccine dose.",None,"['Abnormal dreams', 'Arthralgia', 'Asthenia', 'Back pain', 'Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Neck pain', 'Poor quality sleep', 'Pyrexia', 'Restlessness']",2,PFIZER\BIONTECH,IM 921692,CA,37.0,F,Sore left armpit swollen arm pit swollen lymph node,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/02/2021,3.0,UNK,,,,,,"['Axillary pain', 'Lymphadenopathy', 'Oedema peripheral']",1,MODERNA,SYR 921693,,25.0,F,Body aches and fatigue.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,UNK,,,,,,"['Fatigue', 'Pain']",1,MODERNA,SYR 921694,CT,43.0,F,"about 2 minutes after receiving the shot I felt like I was having an allergic reaction in my chest area. My lower esophagus got extremely tight and then it worked its way up to the back of my throat. It felt like there was a lump in the back of my throat, along with burning in my throat. This same reaction also occurs when I eat certain foods I'm intolerant to. I felt very dizzy right after as well. After exactly one hour my throat symptoms went away but suffered from residual effects for the next few days. The next day I couldn't lift my left arm(which went away 2 days later), I was out of breath with everything I did, dizzy, muscle cramps, chills, body aches(as though I had the flu) and had extreme fatigue. All of theses symptoms lasted for the next week almost two.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/23/2020,0.0,PVT,,,,,Penicillin,"['Chills', 'Dizziness', 'Dyspnoea exertional', 'Fatigue', 'Hypersensitivity', 'Influenza', 'Mobility decreased', 'Muscle spasms', 'Oesophageal stenosis', 'Pain', 'Sensation of foreign body', 'Throat irritation', 'Throat tightness']",1,MODERNA,IM 921695,TX,40.0,F,"Severe headache, bilateral ear pressure, intense vomiting, chills, dizziness, fatigue, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Nexium -OTC Propranolol - 120mg Trokendi - 100mg,None,Factor V Protein C defensivy,,Codeine Latex Primadol,"['Chills', 'Dizziness', 'Ear discomfort', 'Fatigue', 'Headache', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 921696,WI,37.0,F,"Day following vaccination patient experienced redness and hard area at site of injection. This resolved in a few days. Upon waking on day 8 after injection, injection site was erythematous, warm to the touch, hard and itchy. Feels it has progressively gotten worse over the course of the day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,"Zyrtec, IUD, spironolactone, amytriptiline, rizatriptan, finished Accutane 3 weeks prior.",none,"migraines, seasonal allergies, asthma",,"seasonal, tioconazole","['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 921697,FL,,F,"injection site soreness, fatigue, body aches on day #1, lower abdominal pressure and fullness on 1/5/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,PVT,"lisinopril. metformin, crestor, and activell",none,"NIDDM, elevated cholesterol, HTN",,levaquin,"['Abdominal discomfort', 'Fatigue', 'Injection site erythema', 'Pain']",1,PFIZER\BIONTECH,IM 921698,CA,65.0,F,advanced stiff neck that is not going away pain from bottom of ear down neck to injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/01/2021,4.0,UNK,,,,,,"['Ear pain', 'Injection site pain', 'Musculoskeletal stiffness', 'Neck pain']",1,PFIZER\BIONTECH,SYR 921700,IL,45.0,M,After my shot Inhad a lot of energy and felt fine during the day. At night I was shaking uncontrollably. drank water and took tylenol. Fell asleep and woke up soaking wet. Next day I still had a fever. Had chills and my body got warm. This went off and on throughout the day. I was exhausted. At night I had a bloody nose. Went to bed and woke up wet again but not as bad as the first night. Morning time I felt fine. Went to the gym and the sauna. Started to exercise and felt lighted headed and cloudy. Went home laid down. I still feel weird on and off. Went to the bathroom and had black stool. My right arm is still sore.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/04/2021,1.0,PVT,Flonase,Covid-19,Tachycardia,,No,"['Chills', 'Dizziness', 'Epistaxis', 'Faeces discoloured', 'Fatigue', 'Feeling abnormal', 'Feeling hot', 'Hyperhidrosis', 'Pain in extremity', 'Pyrexia', 'Tremor']",1,MODERNA,SYR 921701,OH,66.0,F,"Nausea, slight cough, fatigue, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PVT,"Vitamin b,c,d, COq10, magnesium, milk thistle, dhea,bioten, elderberry, Zyrtec Losartin, Wellbutrin, ropinerole, primadone, keflex, prevastatin,metformen, requip",NONE,NONE,,NKA,"['Cough', 'Fatigue', 'Headache', 'Nausea']",UNK,MODERNA,IM 921702,,36.0,F,"Patient was on a 30 min observation due to previous anaphylaxis to emgality. As she was leaving, she c/o swelling and tingling of lips and appeared anxious. We asked to stay so we can monitor her a little longer. She appeared to stabilize, then she began coughing and trying to clear her throat. She stated it seems have worsened. Epi given and she was transferred to ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,,,,,"IVP dye- Iodine containing, emgality pen","['Anxiety', 'Condition aggravated', 'Cough', 'Lip swelling', 'Paraesthesia oral', 'Throat clearing']",1,MODERNA,IM 921703,WI,56.0,F,"Fever of 101'F oral, body aches, headache, nasal congestion",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,1 TABLET BY MOUTH DAILY atorvastatin (LIPITOR) 40 MG tablet 2 SPRAYS INTO EACH NOSTRIL 2 (TWO) TIMES DAILY FOR 30 DAYS USE IN EACH NOSTRIL AS DIRECTED. biotin 1 mg tablet Use as directed to test blood sugar 1 times per day. Whatever is,None,"Problem List� 14 items Allergic conjunctivitis Depression with anxiety Malignant neoplasm of upper-outer quadrant of left breast in female, estrogen receptor negative (*) S/P lumpectomy, left breast Vitamin D insufficiency Family history of colon cancer Hyperlipemia, mixed (*) Hypertension, essential, benign (*) Obesity (BMI 30-39.9) OSA (obstructive sleep apnea) Encounter for colonoscopy due to history of adenomatous colonic polyps Diabetes mellitus, type 2 (*) Atypical chest pain Gastritis",,Niacin,"['Headache', 'Nasal congestion', 'Pain', 'Pyrexia']",1,MODERNA,IM 921704,MO,42.0,F,"Flu like symptoms that began the day after vaccination, lasting for 1 day. Reported severe residual joint aches in shoulder, scapula, hips, wrists, ankles. Right sided pain persisted, left side lessened. Relieved by NSAIDS",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/19/2020,1.0,PVT,,,,,,"['Arthralgia', 'Influenza like illness']",1,PFIZER\BIONTECH,IM 921705,ID,35.0,F,"Pain in arm since noon that got worse. Headache at 8:00 pm. Diarrhea at 4 AM, vomiting at 4:30 AM, muscle aches all day on 1/5/2021 (day after shot).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PUB,"Abilify, lamictal, levothyroxine, vitamin D, vitamin C",None,"Hypothyroidism, Bipolar I Disorder",,"Vicodin, hydrocodone","['Diarrhoea', 'Headache', 'Myalgia', 'Pain in extremity', 'Vomiting']",1,MODERNA,SYR 921706,SC,48.0,F,"I was diagnosed with shingles on my left side on 12/31/2020, with symptoms (burning/skin sensitivity on my back (probably on 12/27, definitely by 12/28 progressing to waves of pain in my back to abdomen). On 12/30, a rash appeared on my abdomen starting below my navel and going around my left side to about an inch before my spine. I submitted a picture and it was diagnosed as shingles via a virtual visit. It is responding to antiviral therapy, although I still have a rash and pain (but improving). I did not go through the COVID vaccine side effect virtual visit route because I did not really think it was a side effect and knew I had a history of chicken pox and have been experiencing ongoing stress. The provider for the virtual visit told me to still report it for it to be investigated, but she too, thought it was likely unrelated, but still should be investigated.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/27/2020,6.0,WRK,"Altavera,, Norvac, Zyrtec",None,"Mild high blood pressure, controlled with low dose medication, mild environmental allergies, herniated lumbar discs",,"Sulfa drugs, Percocet","['Abdominal pain', 'Back pain', 'Burning sensation', 'Herpes zoster', 'Hyperaesthesia', 'Pain', 'Rash', 'Stress']",1,PFIZER\BIONTECH,SYR 921707,CA,37.0,F,Chills and aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/03/2021,3.0,PVT,"Zoloft, Wellbutrin and abilify",None,Diabetes,,Versed,"['Chills', 'Pain']",1,MODERNA,IM 921708,VA,48.0,F,"numbness on left side of face, left arm and pain in different places on left side started for shortly after vaccine. She has had all these symptoms prior but numbness never this bad. As of today, her symptoms are somewhat less. She has been able to work",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,SEN,"Lisinopril, Metformin, Lexapro",none,Fibromyalgia,,"She says to plastics, nylon and latex","['Hypoaesthesia', 'Pain']",1,PFIZER\BIONTECH,IM 921709,TN,38.0,F,"The say after receiving the vaccine, 12/24, I experienced normal side effects including pain in my arm, fatigue, and mild fever. These SEs improved daily and by Monday, 12/28, I was free from SEs. However on the morning of 12/31 I began experiencing mild pain in my upper left arm again. By mid day I had developed a raised, red, warm area around the injection site a bit smaller than a baseball. I applied an ice pack. The area enlarged by 1/1 and I continued to apply ice and took a dose of diphenhydramine. It appeared to be less red on 1/2 but started to worsen again on 1/3, becoming larger and redder again. It began to itch on 1/4. Today it is larger than the size of my entire hand (including fingers), extending to about 3 inches above the bend of my arm. It continues to be itchy, warm, raised, and red, primarily around the perimeter and the lower portion of the site. While this is not a severe reaction it concerns me that it was delayed and continues to worsen and is not improved by diphenhydramine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PUB,metoprolol tartrate 50mg BID Desvenlafaxine ER 50mg QD,none,"high blood pressure, anxiety/depresion",,none known,"['Fatigue', 'Injection site erythema', 'Injection site mass', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 921710,MT,33.0,F,"Injection site read, inflamed and extremely itchy and slightly swelled. Have contacted PCP waiting to hear back.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,PVT,none,none,Heart Arrhythmia,,none,"['Injection site erythema', 'Injection site inflammation', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA,SYR 921711,GA,29.0,F,"S/sx started at approximately 2130 with fever, chills, body aches. Fever was 102.9. Administered Tylenol 1gm to decrease fever. Rechecked after one hour and temp was still 102.7. S/sx cont throughout night with nausea, body aches, chills, headache, fever. Fever has still yet to break and it?s 1630 on 1/5/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,N/a,Sinus infection about 2 weeks prior to administration of vaccine,"Bipolar, depression",,N/a,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 921712,,35.0,F,"Patient is a 35 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. � She denied any history of previous adverse reactions to vaccines. � She was given the Moderna vaccination in the right deltoid muscle. � During her 15 minute waiting period after the injection, the patient began to experience throat tightness and scratchy throat. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. � This provider was notified of patient reaction and she was then assessed in the emergency bay area. � Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting. � Hx of allergy to flu shot 2013. Had extremity weakness within 12 hours of shot. Resolved within a few days. No medications given. Seen by ER. Hx of 2010 allergy shots to food allergy, corn, wheat and citrus.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,,,,,,"['Throat irritation', 'Throat tightness']",UNK,MODERNA,IM 921714,NJ,70.0,F,"Pfizer-BioNTec COVID-19 vaccine Patient received vaccine on 12/22/2020 and on 12/29/20, she emailed us saying that she was feeling sleepy, tired, was having night sweats, and had headaches. Her head felt like someone had put a heavy stone on it. She can still function.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/29/2020,7.0,PVT,"Atorvastatin 10 mg, dexlansoprazole 60 mg, docusate 100 mg, levothyroxine 75 mcg, pregabalin 50 mg",,"hypothyroidism, hyperlipidemia",,"almonds, cashew, cheese","['Fatigue', 'Head discomfort', 'Headache', 'Night sweats', 'Somnolence']",1,PFIZER\BIONTECH,IM 921715,,50.0,F,"Admit to ER post-vaccine administration for numbness at end of tongue, increased oral secretions and dizziness. She was given benadryl and pepcid, monitored for 3hrs before discharge from ED. Patient still experiencing same symptoms 1 week later per follow-up (12/29)",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,PVT,"Meclizine 25mg qidPRN, Zofran 6mg q6hprn, famotidine 20mg bid",,,,hydrocodone,"['Dizziness', 'Hypoaesthesia oral', 'Salivary hypersecretion']",1,PFIZER\BIONTECH,IM 921716,,35.0,F,"Patient is a 35 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. � She denied any history of previous adverse reactions to vaccines. � She was given the Moderna vaccination in the right deltoid muscle. � During her 15 minute waiting period after the injection, the patient began to experience throat tightness and scratchy throat. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. � This provider was notified of patient reaction and she was then assessed in the emergency bay area. � Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting. � Hx of allergy to flu shot 2013. Had extremity weakness within 12 hours of shot. Resolved within a few days. No medications given. Seen by ER. Hx of 2010 allergy shots to food allergy, corn, wheat and citrus.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,,,,,,"['Throat irritation', 'Throat tightness']",UNK,MODERNA,IM 921717,MA,47.0,F,Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain and swelling fever headache joint pain specifically in hands wrists and neck chills muscle pain nausea feeling unwell,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,none,none,none,,codeine zolipidem,"['Arthralgia', 'Chills', 'Headache', 'Injection site pain', 'Injection site swelling', 'Malaise', 'Myalgia', 'Neck pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 921718,CA,47.0,F,"On 12/31/20 (day 7) of first injection, the injection site area became red, itchy, and inflamed (firm to touch). It was localized to upper arm area surrounding the injection site and the symptoms subsided in about 2 days. As of this reporting the inflammation has gone away, just small circle of slight redness remains with occasional itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/31/2020,7.0,PVT,No,No,No,,No,"['Injection site erythema', 'Injection site induration', 'Injection site inflammation', 'Injection site pruritus']",1,MODERNA,IM 921719,PR,68.0,F,"Red, very painful, swollen injection site started small six days after vaccination and grew doubling in size. The pain takes up from the neck on down to the whole arm. Patient has only taken Naproxene 500.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/02/2021,6.0,OTH,Calcium with Vitamin D3,Diabetes,Diabetes,,Iodine,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Neck pain', 'Pain in extremity']",1,MODERNA,IM 921720,CA,34.0,F,"called in sick 12/30/20, having fever, chills, body aches, cough, sore throat, and headache, tested for COVID 1/4/2021 it was Negative",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/30/2020,8.0,PVT,,,,,,"['Chills', 'Cough', 'Headache', 'Impaired work ability', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 921721,GA,31.0,F,Received Pfizer COVID 19 vaccine on 1/3/21. While waiting 15 minutes in observation patient report tightness to her throat. Was taken to ER,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,,,,,,['Throat tightness'],1,PFIZER\BIONTECH,IM 921722,CA,26.0,F,"12/30/2020 11:30PM- Body Aches, Fatigue, Headache Took Motrin 2 tablets of 200mg 12/31/2020 4AM-Chilles, Fever 102.3F Took Tylenol 2 tablets of 500mg 11AM-woke up with Body aches, head aches, fatigue, Fever 101.9 -went to ED 1:05PM-Fever 101.6F Given Tylenol 2 tablets 500mg, Fever went down to 100F after 1 hr 9PM-Chills, Fever 101.9F Took Motrin 9:18PM 2 tablets 200mg 1/1/2021 11:30AM woke up Temperature 99.1F, slight body aches Did not take any medication. Felt okay the rest of the day. 1/2/2021 Felt Okay No body aches or head aches Temperature of 98.3F 1/3/2021 1230PM Woke up with sore throat and produced a lot of phlegm Drank a lot of water and tea 1/4/2021 Still Producing Phlegm and had sore throat Drank a lot of water and tea, rested when felt fatigued 1/5/2021 No more Sore throat, but is producing phlegm still, staying hydrated, resting and drank tea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,Covid Positive on 12/14/2020,,,Amoxicillin,"['Chills', 'Fatigue', 'Headache', 'Oropharyngeal pain', 'Pain', 'Productive cough', 'Pyrexia', 'SARS-CoV-2 test negative']",UNK,MODERNA,IM 921723,VA,48.0,F,"numbness on left side of body including face, arm and leg Pain on left side in various places Started soon after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,SEN,"Lisinopril, Metformin, Lexapro",none,Fibromyalgia,,"plastics, nylon, latex","['Hypoaesthesia', 'Pain']",1,PFIZER\BIONTECH,IM 921724,MI,37.0,F,"15 min post vaccination face/ears bright red, flushing . Patient reported feeling of ""heart racing"" , dizziness, heat about the face. Vitals taking by staff bp 138/86 given 50 mg Benadryl po. Patient reported dizziness, heart racing subsided. facial coloring returning to norm by 240. Received ride home from staff. Patient reported that she forgot her blood pressure med that morning. She was advised to take it upon arrival home. and follow up with additional Benadryl q 6 hours if needed. monitor at home. Family with monitor at home. Patient was stable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,amlopdipine 5mg bid,none known,hypertension,,bactrim,"['Dizziness', 'Erythema', 'Palpitations', 'Skin warm']",1,MODERNA,IM 921725,FL,,F,"Tingling in the 1st, 2nd, 3rd digits as well as pain at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/16/2020,0.0,PVT,none,None,None,,NKA,"['Injection site pain', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 921726,TX,45.0,F,"Approximately 8 days after vaccination, patient experienced redness, swelling, hematoma, and erythema at injection site. Patient was evaluated in the ER by facility hospitalist and prescribed Bactrim DS twice daily for 7 days with follow-up per MD instructions",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,ramipril 5 mg once daily,none,high blood pressure,,"Penicillin, seasonal outdoor allergies (pollens, molds, etc)","['Injection site erythema', 'Injection site haematoma', 'Injection site swelling']",1,MODERNA,IM 921727,OH,41.0,F,"Developed significant nausea, chills and fatigue about 6-7 hours after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PUB,None,None,None,,None,"['Chills', 'Fatigue', 'Nausea']",1,MODERNA,IM 921728,IA,49.0,M,"Raised, red, itchy area at injection side, about 7 cm, began on day 8 and slowly improved overnight with redness last thing to resolve",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,01/04/2021,8.0,PVT,none,none,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 921729,IN,55.0,F,"Injection site pain, tiredness, headache, muscle pain, joint pain, swollen lymph nodes, and over all not feeling well.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,PVT,,,,,"Tetracycline, codeine, morphine.","['Arthralgia', 'Fatigue', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Malaise', 'Myalgia']",UNK,MODERNA,IM 921730,FL,,F,"pain at injection site, tingling in 1st, 2nd and 3rd digits",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/16/2020,0.0,WRK,None,None,none,,NKA,"['Injection site pain', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 921731,NY,42.0,F,"Approximately 6.5hrs after vaccination, patient developed severe fatigue, some palpitations and dizziness. The next the morning, she had headache, nausea and strange feeling on the tip of throat and nose. She also had pain and swelling in the injection side, no erythema.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Nausea', 'Palpitations', 'Sensory disturbance']",1,PFIZER\BIONTECH,IM 921732,WY,36.0,F,"Numbness in fingertips to knuckles bilaterally RN assessed VS temp 98.4, HR 101, BP 150/88 RR 16",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,Ibuprofen - PRN States she does not take any daily medications,None,None,Rash with last 2 flu shots she received,No known allergies,['Hypoaesthesia'],1,MODERNA,IM 921733,KY,60.0,F,"severe body chills, body aches, headache, fever, nausea , fatigue, face red on left side. Took Tylenol every 4 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,"lisinopril, lipitor",HTN,none,,PCN,"['Chills', 'Erythema', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 921734,NM,23.0,F,"Nausea, fatigue, malaise, vomiting,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,Prazosin I mg daily and probiotic daily,no,"vocal cord disfunction, PTSD",,"Sulfa, CT iodine, prednisone","['Fatigue', 'Malaise', 'Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 921735,MN,52.0,F,"Chest tightness and minimally SOB; weakness, chills generalized feeling of being yucky; did see provider and CXR and EKG normal. States low-grade fever lasted couple of days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,,,,,,"['Asthenia', 'Chest X-ray normal', 'Chest discomfort', 'Chills', 'Dyspnoea', 'Electrocardiogram normal', 'Feeling abnormal', 'Pyrexia']",1,PFIZER\BIONTECH,IM 921736,WI,49.0,F,"Fever of 102'F oral, severe body aches, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Medications� levonorgestrel (MIRENA) 20 mcg/24 hr (5 years) IUD Apply to affected areas 2x/day as directed. spironolactone (ALDACTONE) 100 MG tablet Apply to acne-affected areas at bedtime as directed. valACYclovir (VALTREX) 1000 MG,None,Problem List� 12 items Acne Degeneration of intervertebral disc of lumbosacral region Eosinophilic esophagitis (*) Lumbosacral radiculopathy Adiposity Recurrent herpes labialis Rosacea Vitamin D insufficiency IUD (intrauterine device) in place Obesity (BMI 30-39.9) Acute pain of left shoulder Recurrent herniation of lumbar disc,,None,"['Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 921737,MN,39.0,F,"Fever of 100.2, chills, fatigue, sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Lexapro, Unisom, Birth control pills",None,None,,NKDA,"['Chills', 'Fatigue', 'Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH, 921738,NE,90.0,F,DEVELOPED TIGHTNESS IN THROAT THAT LASTED APPROXIMATELY 15 MINUTES.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,,,,,,['Throat tightness'],1,PFIZER\BIONTECH,IM 921739,CT,27.0,F,Rash at injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,WRK,Wellbutrin Charolette 24 fe,,Fibromyalgia,,Unknown,"['Influenza like illness', 'Injection site rash', 'Lymphadenopathy']",1,MODERNA,SYR 921740,CA,32.0,M,"Fever, chills, fatigue, body aches, pain at injection site, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PUB,Carvedilol,No,Hypertension,,No,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,SYR 921741,NJ,25.0,F,"On 1/4/21 at around 1:30 pm, I was getting ready for work when all of a sudden I started to feel really terrible. My heart was racing, body and face was sweating, externally nauseous, dizzy, blurred/fuzzy vision, body shaking, the room was spinning, and I was unable to stand up. This would happen every time I got out of bed and stood up. Lasted about 2 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/04/2021,12.0,PVT,Elavil 25mg,,Migraines with aura,,Eggs,"['Dizziness', 'Dysstasia', 'Feeling abnormal', 'Hyperhidrosis', 'Nausea', 'Palpitations', 'Tremor', 'Vertigo', 'Vision blurred']",1,MODERNA,SYR 921742,ND,61.0,F,"I had just finished a 10 hour shift, my left upper arm where vaccine was given was tender, I continued working all night in the ER to do call for Radiology dept. around 11:30 pm I started feeling a slight dizzy feeling and tired due to being very busy with ER call backs. at around 12:30 am I just finished a pt. and then shared with ER crew that I do not feel myself and wasn't sure if I was tired from work or maybe from vaccine.. I took my temperature and headed to bed to rest, feel asleep and work up for another call and felt like my fever had broken with a sweat feeling. I felt much better and finished my night on call and home on holiday at 1 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,took Lisiopril in am for blood pressure,none,none,,none,"['Dizziness', 'Hyperhidrosis', 'Injection site pain', 'Pyrexia']",UNK,MODERNA, 921743,,30.0,M,"RASH EN EL CUERPO, DIFICULTAD RESPIRATORIA",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,PUB,,,"ASMA, HIPOGLICEMIA",,"ASA, MARISCOS","['Rash', 'Respiratory distress']",1,PFIZER\BIONTECH,IM 921744,KY,57.0,F,"Received the vaccine during break at work at approx 11:00 am. Sudden onset blinding headache with visual disturbance at 15:30 pm while working. Fifteen minutes after that the headache started to subside and I suddenly became very dizzy and was rolled to a stretcher and assisted to lie down ,associated diaphoresis and pale clammy skin. The following day, experienced significant joint pain and lethargy. I continue to have joint pain but otherwise feel relatively normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Lisinopril Lipitor,None,Hypertension,,Morphine Cipro,"['Arthralgia', 'Cold sweat', 'Dizziness', 'Headache', 'Hyperhidrosis', 'Lethargy', 'Pallor', 'Visual impairment']",1,MODERNA,IM 921745,MO,49.0,F,left arm painful swelling with worsening erythema/redness,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,UNK,"welchol, ergocalciferol, ferrous sulfate, ozempic, gabapenin, atorvastatin, humalog, lantus , cyanocobalamin, lisinopril/hctz , metformin",,"pernicious anemia, DM HTN hypercholesterolemia,",,"victozia -vomiting, jardiance-yeast infections.","['Erythema', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,SYR 921746,MA,37.0,F,Patient with history of and now active ulcerative colitis starting this morning and worsening after Vaccine. She was found bent over in bathroom in abdominal pain with c/o nausea and diarrhea. Brought to EMS-- water given. Patients husband drove her and will drive her home.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,Prednisone,Active episodes of diarrhea in the morning,Ulcerative colitis,,NKDA,"['Abdominal pain', 'Colitis ulcerative', 'Condition aggravated', 'Diarrhoea', 'Nausea']",1,MODERNA,IM 921747,WV,48.0,F,Sore Arm for 24 hours. Advil,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,augmentin; prednisone; Flonase; zytec,sinus infection,none,,none,['Pain in extremity'],1,PFIZER\BIONTECH,IM 921748,,39.0,F,"about 1 week after first shot, develop hard lumps on clavicle (same side as shot given). site very painful and tender. determined to be swollen lymph nodes caused by vaccine.. Currently lumps have decreased in size and no pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/24/2020,6.0,SEN,,,,,,"['Lymphadenopathy', 'Mass', 'Pain', 'Tenderness']",1,PFIZER\BIONTECH,IM 921749,,36.0,F,Patient completed 30 min observation (due to hx of anaphylaxis to emgality) and as she was leaving she c/o lips swelling and tingling in throat. Pt was asked to stay for further observation. A few minutes later pt began to cough and stated worsening swelling in throat. Epi given and pt transferred to ED,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,IVP dye-iodine containing; emgality pen,"['Cough', 'Lip swelling', 'Pharyngeal paraesthesia', 'Pharyngeal swelling']",1,MODERNA,IM 921750,TX,54.0,F,"Fever began on 24th around 10 with chills. Took Tylenol for low grade fever about 12:30 pm. Subsided for 6 hours and then 6:30 that evening it returned at 100.7. Again 6 hours later, fever was 100.4. Christmas day, still had fever around 100. Then again that afternoon. Lymph node swelling underneath the arm. The site of the injection I had a large knot. Very swollen, small bruise, hot, and red. No streaking or red lines. Lymph node underneath the arm was about the size of a ping pong. I did not want to go to the ER. I called the nurse line and was triaged over the phone. I was instructed to take BP and pulse and gave numbers over the phone. BP was a little elevated, but nothing to extreme. I pretty much stayed laying down. It sucked the life out of me. I used hot compress and cold compress on site of the injection. It was late Saturday evening when I decided to see a change in the size of the lymph node. By Sunday, the 27th, there was no fever. Not even on Saturday. By Sunday, the lymph node had subsided as well. I did get a headache, but it was like a nagging headache. My left shoulder in the muscle area towards the neck area, I had soreness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,"Losartan, Cingular, and Selexa, over the counter Tylenol.",No,Asthma,Tetanus with another vaccine. Increased swelling and redness. This happened approximately 2 years ago.,"Pineapple, Kiwi, Foods with MSG, Aphylactic with NSAIDs","['Arthralgia', 'Blood pressure increased', 'Chills', 'Contusion', 'Erythema', 'Fatigue', 'Headache', 'Injection site nodule', 'Lymphadenopathy', 'Neck pain', 'Pyrexia', 'Skin warm', 'Swelling']",UNK,PFIZER\BIONTECH, 921751,GA,55.0,F,"painful, egg -size lump under left armpit. no redness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PVT,tessalon perles hydrochlorothiazide metoprolol gabapentin,none,history of breast cancer (remission for 6 years) hypertension,,none,"['Axillary mass', 'Axillary pain']",1,MODERNA,IM 921752,,30.0,M,"RASH, RESPIRATORY DIFFICULTY",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PUB,,,ASTHMA,,"SEAFOOD, ASA","['Rash', 'Respiratory distress']",1,PFIZER\BIONTECH,IM 921753,LA,32.0,F,Very sore around injection site. Moderate nausea and vomiting.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Welbutrin, Desfenlafaxine, Zolpidem ER",None,Depression,,NKA,"['Injection site pain', 'Nausea', 'Vomiting']",1,MODERNA,IM 921754,OH,41.0,F,"This individual received her first dose of Moderna Covid vaccine on 1/4/21. She called in on 1/5/21 at 1:08pm to report that she is not feeling well. She reports chills, extreme nausea, very tired, and arm swollen to approximately golf ball size in the arm she received the vaccination. She called off work on 1/5/21 due to her symptoms. She received physician advice from her place of employment to alternate Tylenol and Motrin to help with the symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Malaise', 'Nausea', 'Vaccination site swelling']",,MODERNA,IM 921755,MN,51.0,F,"Within 10 minutes of vaccine administration, patient reported that her arm began feeling warm, she then had numbness and tingling in her face and reported her throat felt warm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,azlaic acid topical biotin buproprion buspirone vitamin d3 cranberry extract vitamin b12 lunesta ferrous sulfate flonase westcort cream nizoral shampoo priobiotic elocon cream ditropan xL sertraline sulfacetamide sodium cream tretinoin crea,Denies,"Iron deficiency, Thyroid nodule, pyelonephritis, menorrhagia, hematuria, sepsis, ADHD, Anxiety, Depression, Sleep Apnea",,Allergic rhinitis,"['Feeling hot', 'Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 921756,WY,36.0,F,"Numbness in fingertips to knuckles VS: temp 98.4, HR 101 RR 16 BP 150/88",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,Ibuprofen -PRN No OTC or Rx that she takes daily,none,none,Rash on arm last 2 flu shots she received,No known allergies,['Hypoaesthesia'],1,MODERNA,IM 921757,AL,36.0,F,PATIENT HAD INJECTION AND HAD NO PROBLEMS WAS RELEASED THEN RETURNED WITHIN 30 MINS STATING SHE FELT LIKE HER TONGUE WAS SWELLING. PATIENT WAS REASSESED AND OBSERVED FOR ADDITIONAL 15 MINS AND STATES FEELS FINE. PATIENT RELEASED AGAIN.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,?,?,?,,?,['Swollen tongue'],1,PFIZER\BIONTECH,IM 921758,TX,47.0,F,Vaccine administer 12/23/2020 woke up 12/27/2020 with itchy palms and feet took cetrizine 10mg bid itching stopped. Some itching here and there. Sat. 1/2/2021 in the evening started itching certain parts this time red swollen rash patches stayed on skin. Till this day still have itchy parts on body with rashes comes and goes. Scalp itches as well. Do feel some burning sensation on skin. I can feel burning sensation inside of body with itch. Patches warm to touch as well. Have not seen a doctor for this issue. Do work for a doctor and blood work orders were just for a check up.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/02/2021,10.0,PVT,Ibuprofen 200 mg 3 pills taken 1 hour prior to vaccine,None,None,,No,"['Full blood count normal', 'Metabolic function test normal', 'Pruritus', 'Rash', 'Rash erythematous', 'Rash papular', 'Skin burning sensation', 'Skin warm']",1,MODERNA,IM 921759,NY,79.0,M,BILATERAL WHEEZES SHIVERING FLUCTUATING OXYGEN SATURATION SKIN FLUSH,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,SEN,"AMLODIPINE, ASPIRIN, BUSPIRONE, FLOMAX, DIVALPROEX SODIUM, LOSARTAN, LOPRESSOR, SINGULAIR",,"HTN, COPD",,NKDA,"['Chills', 'Flushing', 'Oxygen saturation abnormal', 'Wheezing']",1,PFIZER\BIONTECH,IM 921760,VA,26.0,M,he reports noticing a (L) supraclavicular nodule about 1-2 days ago,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/03/2021,11.0,PVT,,,,,,['Lymphadenopathy'],1,PFIZER\BIONTECH,IM 921761,MI,38.0,F,"Estimated due date: 07/09/2021. Around 8PM I started feeling chills, and arm pain and the next day in fact the next 2 days the pain was rather severe, I could not even lift my arm needed help with dressing, showering etc. Fatigue started on the 24th and slept all through the day until the 26th. On the 27th and 28th fatigue got better and arm was also feeling a little better, could lift my arm. Friday and Saturday was very hard on the fatigue again by Sunday the 27th I was back at feeling fine and I have been fine since. Although had chills no fever. January 1st and second I also had headaches.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"prenatal vitamins, vitamin D, astrad tablet, estrogen's patch, progesterone injections (2ml daily) , centroid 25mcg daily",no,no,2013 - I had a pretty bad reaction to the flu vaccine - I had a 8/9 day vaccine reaction,"anaphylaxis to sulfa, microlites","['Chills', 'Exposure during pregnancy', 'Fatigue', 'Headache', 'Joint range of motion decreased', 'Loss of personal independence in daily activities', 'Pain in extremity', 'Somnolence']",1,MODERNA,SYR 921762,TX,40.0,F,"12/19 - Elevated heart rate, trouble breathing. No med attn needed. 12/23 - 7pm Chills (2hrs), 9pm low grade fever, 11pm 101.2 fever, body aches, fatigue (2 days). Took Ibuprofen. Fever did not go over 99 after Ibuprofen. 2-3 episodes of diarrhea. Seen by PCP on 12/24 via after hours clinic. Recovered in 4 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,WRK,No,No,Asthma,,No,"['Chills', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Full blood count', 'Heart rate increased', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,IM 921763,IA,52.0,F,Received vaccine 12/23/20. On 12/31/20 noticed a 3 1/2 inch diameter reddened area to injection site. Area swollen. On 1/5/21 area decreased to light red but still swollen.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PVT,"famotidine, valtrex, aimovig, predinisolone eye drop",,,,,"['Injection site erythema', 'Swelling']",1,MODERNA,IM 921764,AL,28.0,F,"About 1 hour after the vaccine, I developed watery eyes, itchy, runny nose, sneezing, itchy throat. This lasted throughout the day and required 50mg of Benadryl before symptoms finally subsided around 9pm that night.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,None,None,None,,None,"['Lacrimation increased', 'Pruritus', 'Rhinorrhoea', 'Sneezing', 'Throat irritation']",1,PFIZER\BIONTECH,IM 921765,WA,41.0,F,"Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash on flexural of both arms, started with just left then progressed to both arms 12/27; achy feeling still; ""gross feeling;"" swollen lip with blister, started 1/3; left supraclavicular lymph node swollen",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/26/2020,0.0,PVT,"Gabapentin, Zofran, Valtrex, Albuterol inhaler",,CIN III with severe dysplasia;,,"Cefuroxme, Codeine, Erythromycin, Hydrocodone, Dilaudid, Propoxyphene, Tramadol, Oseltamivir","['Feeling abnormal', 'Immediate post-injection reaction', 'Lip blister', 'Lip swelling', 'Lymphadenopathy', 'Nausea', 'Pain', 'Paraesthesia', 'Rash', 'Skin warm']",1,PFIZER\BIONTECH,IM 921766,CA,34.0,F,"12/31/2020--within the hour of vaccination, tingly sensation of the right arm with mild soreness. 01/01/2021--immense soreness of the right arm, unable to even lift arm above head without feeling pain, extreme sensitivity on the area where shot was given. Extreme weakness, unable to even rip a napkin. 01/04/2021--unexplainable neck and shoulder pain on the right side (where vaccine was administered). Tensed neck and should joints, fatigue, lacked appetite. 01/05/2021--continued neck and shoulder pain on right side.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,WRK,None,None,None,,"Latex, Wasabi","['Arthralgia', 'Decreased appetite', 'Fatigue', 'Injection site pain', 'Joint stiffness', 'Mobility decreased', 'Musculoskeletal stiffness', 'Neck pain', 'Pain', 'Pain in extremity', 'Paraesthesia']",1,MODERNA,IM 921767,ID,53.0,M,"I had moderate to severe covid in August 2020. I recovered. I had antibodies test completed on 12/22/2020 at hospital, my results were positive for antibodies with score of 205. Dec 31, 2020: Severe Chilling and shaking, teeth rattling shaking, unable to get warm, Extreme fatigue, unable to stay awake, watch registered 4k steps despite me being in recliner for the day due to the shaking of body. Jan 1, 2021: Intense head ache, muscle aches and red and swelling welt at immunization site. Recurrent fever, excessive sweating, soaked through tshirt, polo shirt twice, extreme fatigue. Same symptoms continue until Jan 5, 2021. Symptoms were definitely more intense than just a casual body ache or fever. It felt like my body had covid again even though i know it is not possible to catch covid again from vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Lisinopril 20 mg x day AmLODIPine Besylate 5mg Atorvastayin Calcium 40 Mg,None,High Blood Pressure High Cholesterol Obese,,"Allergic to Penicillian, Amoxycillian","['Chills', 'Fatigue', 'Feeling cold', 'Headache', 'Hyperhidrosis', 'Injection site reaction', 'Myalgia', 'Pain', 'Pyrexia', 'Tremor', 'Urticaria']",1,MODERNA,IM 921768,WA,58.0,F,"Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was employed as a housekeeper. About one hour after receiving the vaccine she experienced a hot flash, nausea, and feeling like she was going to pass out after she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours, upon arrival to a friends home she complained of feeling hot and having difficulty breathing. She then collapsed, then when medics arrived, she was still breathing slowly then went into cardiac arrest and was unable to be revived.",Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,,,,,None Known,"['Cardiac arrest', 'Death', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Feeling hot', 'Hot flush', 'Lethargy', 'Nausea', 'Respiratory rate decreased', 'Syncope']",1,PFIZER\BIONTECH,IM 921769,MO,61.0,F,"Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseated. Continued to have worsening symptoms. Nausea/Vomiting, muscle twitching, severe headache, increased heart rate went to ED on 1/5 at 0100.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Feeling jittery', 'Headache', 'Heart rate increased', 'Muscle twitching', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 921770,NY,33.0,M,"Fever tmax 101 night of administration, 4 days of muscle aches and fatigue on 1/3/2021 I had a fever at bedtime of 101.5, treated with tylenol and ibuprofen. Afebrile next day (1/4/2021) until evening, when I had a fever tmax 101.6 until 4AM. Took Tylenol and Aleve. Profuse night time sweating.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/01/2021,4.0,PVT,Descovy Prozac 20mg Vit D Vit B Magnesium,,,,,"['Fatigue', 'Influenza virus test negative', 'Myalgia', 'Night sweats', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 921771,MA,35.0,F,"Shortly after admin had rapid heartbeat which only lasted 2 min (120-140s) but the significantly fast and pounding in nature. RNS are on site attributed to nerves, but has no h/o anxietyl. Patient is very concerned about next dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,WRK,,,,,,"['Heart rate increased', 'Nervousness', 'Palpitations']",1,MODERNA,IM 921773,AR,46.0,F,"3 WEEKS POST VACCINE AND ARM MUSCLE/SHOULDER HAS PRETTY SEVERE PAIN. IT HURTS TO RAISE MY ARM ABOVE MY HEAD, SHAMPOO/BRUSH MY HAIR, ETC....",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,"PREVIFEM, BUPROPION HCL, JANUVIA 100 MG",NONE,DIABETIC,,NONE,"['Mobility decreased', 'Myalgia', 'Pain in extremity']",UNK,PFIZER\BIONTECH,IM 921774,,51.0,F,"Client stated at 10:48 she noticed chest tightness, then a hot&cold sensation in her throat,neck and then down the remainder of her body. Stated she has had COVID 2 times and has viral myocarditis from COVID and gets chest tightness at times. Blood pressure 132/80. 11:13 states easing up on the chest tightness. Will continue to monitor. 11:23 Chest tightness improved states she is ready to go. Was asked to go to ER just for safety. Said she did not want to. Stated she has had a cardiac work up and it was not necessary. Blood pressure 122/80 Pulse68. Alert and orientedx3, respirations even and unlabored. Skin pink,warm and dry. Was informed if she would not go now, to please go with any further problems.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,UNK,,,,,,"['Chest discomfort', 'Condition aggravated', 'Feeling of body temperature change']",1,MODERNA,IM 921776,VA,48.0,F,"numbness left side of body including face, arm, leg pain left side of body in several places",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,SEN,"Lisonopril, Metformin, Lexapro",no,Fibromyalgia,,"plastics, nylon, latex","['Hypoaesthesia', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 921777,PR,40.0,F,Headache congestion clear nasal discharge throat pain and inflamation no smell no taste,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,Zithromax zyrtec d flonase acetaminophen,No,No,,No,"['Ageusia', 'Anosmia', 'Headache', 'Influenza virus test negative', 'Mycoplasma test negative', 'Oropharyngeal pain', 'Paranasal sinus hypersecretion', 'Pharyngitis', 'Respiratory tract congestion', 'SARS-CoV-2 test negative', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 921778,MS,57.0,F,"EMPLOYEE C/O DIZZINESS, HOT THROAT THAT QUICKLY TURNED INTO SCRATCHY THROAT. BP ELEVATED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,"MELOXICAM, CETRIZINE HCL, LEVOTHYROXINE, MONTELUKAST SODIUM, PROGESTERONE, MULTIVITAMIN, B-12, CoQ10",NONE,"ARTHRITIS, HYPOTHYROIDISM, ALLERGIES",,"CATS, VANCOMYCIN","['Blood pressure increased', 'Dizziness', 'Feeling hot', 'Throat irritation']",1,MODERNA,IM 921779,CA,27.0,F,27 yo F presented to COVID vaccine clinic to receive vaccination. Post vaccine started having palpitations and headaches as well as chest tightness. Patient currently taking albuterol post covid infection. Pt recently diagnosed with COVID 12/13 with onset of symptoms on 12/11 discharged as of 12/22 and currently working. Last set of vitals prior to EMS arriving was 117/57 spo2 83. Patient reported feeling cold. Patient was provided with juice and cracker and transported to the ED via EMS.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/24/2020,0.0,UNK,Albuterol 90 mcg inhaler,,,,,"['Chest discomfort', 'Feeling cold', 'Headache', 'Palpitations']",1,MODERNA,IM 921780,MI,29.0,F,Woke up at 12:40 in the morning and was covered in hives and my face and ears were swollen,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,WRK,"Effexor, lexapro, aldectone, B12 supplement",Hives for 3 weeks-cause unknown,"Depression, anxiety, poly cystic ovarian syndrome",,Amoxicillin and sulfa,"['Condition aggravated', 'Ear swelling', 'Swelling face', 'Urticaria']",1,PFIZER\BIONTECH,SYR 921781,CO,55.0,F,"left arm pain and swelling that started 2 days after vaccine, improved for a ""few days"" and then returned accompanied by itching at injection site and on upper left arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/26/2020,3.0,MIL,unknown,none reported,"diabetes, post menopausal",,none reported,"['Injection site pruritus', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 921782,TX,39.0,F,"I had arm soreness from the time of injection to the next few days, Saturday morning I had moderate tiredness and body aches and headaches that were really bad until the 23rd that was sporadic. I felt feverish malaise really bad headache and body aches. I took Tylenol and Advil around the clock. on the 20th I also had very mild runny nose for 2 days. I went to get a covid test on the 23rd and it was negative. Symptoms resolved by the 25th I had no symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/19/2020,2.0,PUB,no,no,Type 1 diabetes,,mice,"['Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Pain', 'Pain in extremity', 'Pyrexia', 'Rhinorrhoea', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,SYR 921783,IL,80.0,F,"Dry mouth, Nausea, Headache",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,"Ferrous Sulfate, Atorvastatin, Fluconazole, PreserVision AREDS, Eliquis, Vitamin D3, Diltiazem, Levothyroxine, Sertraline",,"Arthritis, Hypertension, Heart Failure, Depression, Cardiac Arrythmia, Iron Deficiency Anemia, Hyperlipidemia, Hypothyroidism, Atrial Fibrillation",,"Ceftriaxone, Benadryl, Betadine","['Dry mouth', 'Headache', 'Nausea']",1,MODERNA,IM 921784,MO,60.0,F,"Fatigue on Friday 1/1/21 (2 naps resolved fatigue on 1/1/21) and daily napping resolve fatigue 1/2/21-1/4/21 Headache on Saturday, 1/2/21. Took nap to resolve Blurry vision Sunday when reading began on 1/3/21 and has not resolved as of 1/5/21. Pain behind left eye on morning of 1/5/21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/03/2021,3.0,PVT,Ibuprofen,None,None,,"Tetracycline, seasonal","['Eye pain', 'Fatigue', 'Headache', 'Vision blurred']",1,PFIZER\BIONTECH,IM 921785,MI,27.0,M,"Body ache, headache, body weakness, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,,,,,,"['Asthenia', 'Fatigue', 'Headache', 'Pain']",1,PFIZER\BIONTECH,IM 921786,MI,75.0,M,tremors resident sent hospital facility.,Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/03/2021,01/03/2021,0.0,SEN,"Metformin, Keppra, Eliquis, Metoprolol Succinate, Mesalamine, Colace , bupropin ER and Ferrous Sulfate given at 10am on 1-3-21",,"A-fib, HTN, Type 2 DM, Dementia and hyperlipidemia",,NKA,['Tremor'],1,MODERNA,IM 921787,MA,35.0,F,"Shortly after admin had rapid heartbeat which only lasted 2 min (120-140s) but the significantly fast and pounding in nature. Facility RNS are on site attributed to nerves, but has no h/o anxiety. Patient is very concerned about next dose",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,WRK,,,,,,"['Heart rate increased', 'Nervousness', 'Palpitations']",1,MODERNA,IM 921789,ND,88.0,M,Nausea--very sick to his stomach since 1/5/2021 AM,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PUB,"Albuterol, alendronate, budesonide, Citrical, Vitamin D3, clopidogrel, fluocinonide, fluticasone, furosemide, gabapentin, Norco, Duoneb, Slow-Mag, metoprolol, naproxen, Nitrostat, pravastatin, Tamsulosin, triamcinolone topical",None. Had Covid-19 in September 2020.,"coronary artery disease of native artery of native heart with stable angina pectoris, hypertension, RBBB, Spinal stenosis, lumbar region without neurogenic claudication, Bil. carpal tunnel syndrome, Age-related osteroporosis, Thoracic disc herniation, osteroarthritis of lt. knee, lumbosacral radiculopathy at L5, Kidney calculus, Truncal ataxia from hx, repeated falls from hx, hyperlipidemia, and hypomagnesemia from hx",,No Known Allergies,"['Abdominal discomfort', 'Nausea']",1,MODERNA,IM 921790,TX,62.0,M,Soreness/pain at injection site for about 1 day,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,Creator,None,None,,None,['Injection site pain'],UNK,MODERNA, 921791,MD,44.0,F,"Chills, nausea, vomiting, tinnitus, weakness, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,"Synthroid, Augmentin, rosuvastatin, Trintellix, loloestrin fe, topamax, montelucast, dymista, minocycline, Zyrtec,",Sinus infection,"Hypothyroidism, seasonal allergies, hyper cholesterol Emma, migraines","Pertussis, baby, anaphylaxis; yellow fever, 20, anaphlaxis","Sulfa, latex","['Asthenia', 'Chills', 'Headache', 'Nausea', 'Tinnitus', 'Vomiting']",UNK,MODERNA,IM 921794,,30.0,F,warmth in both arms,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,PVT,none,none,none,,sulfa,['Skin warm'],1,MODERNA, 921795,CT,62.0,F,"Chills, headache, fever, achey",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,WRK,"Medi weight loss fat burner, medi weight loss inner balance supplement, Tylenol 3",,"Neck and Back Pain L4,5 S1",,"Penicillin, Sulfa, Shellfish","['Chills', 'Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH,IM 921796,TN,49.0,F,"Started out vague. Started with headache at the base of her head and then it felt like a web that covered her entire head. By 10:00 she did not feel good. Went to sleep instantly. Slept for about an hour. Began to have nausea. Sunday headache got worse. Started ringing , buzzing sound in her head. Took Zofran because of nausea. Sunday night chest discomfort. Monday had horrible chest pain, headache was horrible, then vomiting. went to ER, doctor felt it was a reaction to the vaccine. was give medicine for nausea and Decadron for the reaction. Gave fluids for dehydration. Got medicine for headache. Keep taking Zofran for nausea. Still has headache. Has appointment with pcp in the morning.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/02/2021,01/02/2021,0.0,PUB,"Wellbutrin, Microbid",no,ESBL,,Buspar,"['Cardiovascular evaluation', 'Chest X-ray', 'Chest discomfort', 'Chest pain', 'Dehydration', 'Feeling abnormal', 'Headache', 'Laboratory test', 'Nausea', 'SARS-CoV-2 test negative', 'Tinnitus', 'Urine analysis', 'Vaccination complication', 'Vomiting']",1,MODERNA,IM 921797,TX,47.0,M,"Fever of 102-103 for three days. Chills, fatigue, headache, blurred vision, dizziness, body aches, congestion, and small productive cough for five days. Fatigue, headache, slight dizziness and improving cough on days six and seven (today).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,None,None,None,,Allergic to codeine. Food allergies to tomatoes and oranges. Skin allergies to fragrances.,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Pain', 'Productive cough', 'Pyrexia', 'Respiratory tract congestion', 'Vision blurred']",1,MODERNA,IM 921798,MD,60.0,F,"Red, itchy rash to both upper and lower extremities and upper back. Started 1/01/2021 to present. Treated with prednisone 60 mg x 5 days and trimcinolon 0.025% topically",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,OTH,"Norvasc 5 mg daily Hztz 25 mg orally daily Vtamin D 50,000 units weekly Calcium 600 orally daily Atoravastatin 10 mg daily","Hypertension, Hyperlipidemia, PVD, HPV.","Hypertension, Hyperlipidemia, PVD, HPV.",,"Penicillin, Naproxyn, Claritin","['Erythema', 'Rash', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 921799,MN,54.0,F,Itchy eyes and hives on most of body that started 2 hours after injection. I took 50mg of Benadryl and that put me to sleep. When I woke the hives were gone but I still itches another day. I took Claritin which did not help. When I got home from work I took 25mg of Benadryl which took care of symptoms. Eyes have been itchy off and on still.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Effexor XR 75, Lisinopril 10, Vit D, Tumeric, Magnesium",None,Controlled high BP Arthritis,,NKA,"['Eye pruritus', 'Urticaria']",1,PFIZER\BIONTECH,SYR 921800,GA,27.0,F,"Fever, body aches, chills, nausea, headache, soreness at injection site - all hindering normal daily activities such as performing work. This is day 8 of receiving vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,UNK,Topiramate 100 mg Pristiq 100 mg Nortriptyline 30 mg (3 - 10 mg) Emgality 120 mcg Adderall XR 30 mg Rizatriptan ODT 10 mg,,"ADHD, GAD, depression",,Benzocaine,"['Chills', 'Headache', 'Impaired work ability', 'Injection site pain', 'Loss of personal independence in daily activities', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 921801,NY,46.0,F,"increased heart rate, palpitations, difficulty breathing, subsided within 7 minutes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,shellfish,"['Dyspnoea', 'Heart rate increased', 'Palpitations']",1,MODERNA,IM 921802,NY,51.0,M,"Patient developed tingling on the tongue 7 days after vaccine and developed unilateral facial weakness 9 days later diagnosed as bell's palsy and started on Prednisone, Valcyclovir and ophthalmic Lubricants.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/29/2020,8.0,PVT,Diabetic Medications,No acute illness,Type 2 Diabetes,,None,"['Computerised tomogram', 'Facial paralysis', 'Facial paresis', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 921803,MA,49.0,F,"When she was injecting, had pain. Then felt heat flushed down arm. Felt really hot, felt heart racing. Got tunnel vision; got dizzy and felt like she was going to faith. BP up to 160/104 with HR 140. No meds given; just water. Took 30 minutes to recover. No recurrence",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,,,,,,"['Dizziness', 'Feeling hot', 'Flushing', 'Immediate post-injection reaction', 'Injection site pain', 'Palpitations', 'Skin warm', 'Tunnel vision']",1,MODERNA,IM 921804,VA,45.0,M,"Patient reported throat feeling dry 5 minutes after vaccine administration. He drank some apple juice. He reported that his throat felt tight, and that he was becoming hoarse about 25 minutes after vaccine administration. He was able to walk to a treatment area, where he was assessed and 0.3 ml Epinephrine by Epi Pen was administered into antero lateral thigh, and EMS was called. Patient reported symptom improvement after 3-5 minutes. EMS transported patient to the Emergency Department for evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PUB,Unknown,None reported.,Unknown,Rabies Vaccine,"Individual reports being allergic to Penicillin, and previous reaction to a rabies vaccine.","['Dry throat', 'Dysphonia', 'Throat tightness']",UNK,MODERNA, 921805,CO,61.0,F,"left arm soreness that started 2 days after injection, went away then returned accompanied by swelling and itching",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/25/2020,2.0,MIL,unknown,none reported,none reported,,"ceftin, Percocet, sulfa drugs, codeine","['Pain in extremity', 'Peripheral swelling', 'Pruritus']",1,MODERNA,IM 921806,CA,63.0,F,tongue swelling that started 15-30 minutes after injections patient was taken to ED and given IV Benadryl 50mg and symptoms resolved,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,"Atenolol, Atorvastatin, Metformin, Hydrochlorothiazide",none,"asthma, Diabetes, Hypertension, sleep apnea",,"Aspirin, Betadine, Lisinopril, Penicillins class, Tetracycline",['Swollen tongue'],1,PFIZER\BIONTECH,IM 921807,CA,34.0,F,"Presented difficulty breathing and some pressure on the chest. Started 24 hours after the vaccine. The symptoms lasted 48hours. No treatment was taken, symptoms disappeared after 48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,,,,,,"['Chest discomfort', 'Dyspnoea']",1,PFIZER\BIONTECH,IM 921809,TX,24.0,F,SHORTLY AFTER RECEIVING INJECTION SHE BEGAN TO NOTICE THROAT TIGHTNESS AND TINGLING SENSATION IN EXTREMITIES - TO ER FOR OBSERVATION - ADMINISTERED DIPHENHYDRAMINE HCL. RECOVERED AND DISCHARGED,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,NONE,NONE,NONE,,NONE,"['Paraesthesia', 'Throat tightness']",1,MODERNA,IM 921811,CO,84.0,F,"has a rash that started in her feet, not spreading. Appears to be mottled, not raised. Blanching rash. NO pain, not itching. Started later the day she got the vaccine. Maybe improving but they are unsure.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,vitamin C aspirin 81 mg vitamin D HCTZ ibuprofen losartan B12 memantine,none,"htn, hyperlipidemia, dementia",,none,"['Pallor', 'Rash']",UNK,MODERNA, 921813,,24.0,M,Moderna COVID-19 Vaccine EUA Awoke morning of 1/1 (about 36 hours after receiving vaccine) with mild fever and general malaise,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,UNK,"Zyrtec, Lysine",,,,,"['Malaise', 'Pyrexia']",UNK,MODERNA,IM 921814,IL,47.0,F,"Felt feverish 4 hours after the injection. Followed by pain, tenderness on L arm. Had an episode of runny nose in the afternoon. In the evening, felt fatigue, mild headache. Took tylenol. Felt achy all over the day after, temperature of 101. Resolved with tylenol. Still with L arm tenderness, headache, achy joints. + swelling on L arm injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Losartan, Verapamil, Vitamin",none,"HTN, perrenial allergies",,"NSAIDs, environmental","['Arthralgia', 'Fatigue', 'Headache', 'Injection site swelling', 'Pain', 'Pain in extremity', 'Pyrexia', 'Rhinorrhoea', 'Tenderness']",1,MODERNA,IM 921817,CO,28.0,F,"45-60 minutes after receiving the vaccine she had numbness on the left side of her face/cheek associated with some mild swelling to the area. Maybe some mild left tongue swelling. Normal swallowing, normal breathing. No cough. No vomiting or diarrhea. No rash. She called an urgent care who recommended Benadryl, which helped minimize the tingling sensation and swelling over the next 2 days. Over the following week she had soreness at her left jaw joint near her ear and some left eye dryness. No facial droop. Normal blinking and smiling. No facial muscle weakness noticed. She was not sick when she received the vaccine. No new medications. Tolerates NSAIDs normally without reaction. No facial fillers. Never had anaphylaxis before to anything -- foods, medications, injectables, other vaccines. No known PEG allergy. Has not used Miralax before.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"Multivitamin, vitamin D, oral contraception (desogestrel-ethinyl estradiol)",None,"Depression, anxiety, irritable bowel syndrome",,None,"['Dry eye', 'Hypoaesthesia', 'Pain in jaw', 'Paraesthesia', 'Swelling face', 'Swollen tongue']",1,MODERNA,IM 921818,CA,54.0,F,"Vertigo, Positional Vertigo, Nausea/Vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,SEN,none,none,none,,none,"['Nausea', 'Vertigo', 'Vertigo positional', 'Vomiting']",1,PFIZER\BIONTECH,IM 921819,LA,30.0,F,"severe soreness in the arm vaccine was given, fatigue, dizziness, nausea, and fever and post nasal drip",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,tylenol & cephalexin,viral gastroenteritis & uti,none,,"robaxin, norco","['Dizziness', 'Fatigue', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Upper-airway cough syndrome']",UNK,MODERNA, 921820,MO,18.0,F,swelling and redness to injection site. Hives to neck. Pt reports of sore throat limited to the side of the injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/04/2021,6.0,PVT,,,,,pcn,"['Injection site erythema', 'Injection site swelling', 'Oropharyngeal pain', 'Urticaria']",1,MODERNA,IM 921822,LA,50.0,F,Fever 100.3 Body aches Trouble breathing Chills Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Iaso tea,None,None,Itching and redness,Penicillin,"['Chills', 'Dyspnoea', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 921823,TX,39.0,F,"1 week after vaccine given, swelling, rash, and itching occurred at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,,,History of Asthma,,NKDA No allergies,"['Injection site pruritus', 'Injection site rash', 'Injection site swelling']",UNK,MODERNA, 921824,OH,62.0,F,"Fever, highest 101.3, chills, fatigue, body aches, headache. Treated with Tylenol and Ibuprofen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,PUB,,,"Diabetes, Obesity, Hypertension",,"Penicillin, Lisonipril","['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 921825,CO,61.0,F,"Selling of lips, tingling and numbness of the inside of mouth. Lasted for 8 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,WRK,"Amlodipine, vitamin b12, calcium, pregnenolone, vitamin d3, testosterone, estrogen, armour thyroid, magnesium, dim-pro",None,Hypertension,,"Fentanyl, levaquin, psyllium husk, latex, newly opened can of tennis balls","['Hypoaesthesia oral', 'Lip swelling', 'Paraesthesia oral']",1,MODERNA,IM 921826,FL,52.0,F,"I went home and took my daily nap. I was really tired and not feeling well. The next morning, I woke up with a fever and I had fatigue. I was also coughing and had SOB. The doctor said I needed to go to urgent care. I had a breathing tx and a steroid injection. I was told I also had a respiratory infection. I was also given steroid pills, antibiotics and pump. Still have a lingering cough.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,Vitamin D3 Elderberry,I tested positive for COVID on Nov 23,,,,"['Chest X-ray normal', 'Cough', 'Dyspnoea', 'Fatigue', 'Malaise', 'Pyrexia', 'Respiratory tract infection']",1,PFIZER\BIONTECH,IM 921827,MN,62.0,F,Had gotten a headache within 1/2 hour of getting the injection. Within 2 hours after receiving the injection my arms started to itch and upper back areas. Within 4 hours I noticed rash like redness with tiny little spots/bumps all up and down both arms and the itching was getting worse with both arms and upper back areas. This went away by Friday evening. I had the headache until the following Monday evening.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,Vitamin D3 and Vitamin C,None,Cardiac health issues,Shingles vaccine,"Medications, Atenolol, Bactrim, Penicillin, Sulfa antibiotics, Levofloxacin, Tramadol and Zolpidem","['Erythema', 'Headache', 'Rash', 'Rash pruritic']",UNK,PFIZER\BIONTECH,IM 921828,MS,58.0,F,"Employee reported temp of 101.0, with chills, Head ache, body aches, diarrhea, arm pain & night sweats.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Body temperature increased', 'Chills', 'Diarrhoea', 'Headache', 'Night sweats', 'Pain', 'Pain in extremity']",1,MODERNA,IM 921829,MN,81.0,M,"Received COVID-19 Moderna vaccine on 12/28. Developed nausea, vomiting, diarrhea, fever, and hypoxia at facility the day follow vaccine administration (12/29). He was sent to the hospital on 12/29 and admitted for post vaccine fever where he had a chest x-ray that showed infiltrates but WBC count was normal and fever resolved upon admission to hospital. Provider documented ""expected reaction to vaccination in a patient with previous COVID exposure"". He returned to the facility on 12/30.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/28/2020,12/29/2020,1.0,SEN,"Acetaminophen, Aspercreme Lidocaine Liquid 4 %, Biotene Dry Mouth Liquid (Mouthwashes, ,Calcium Antacid Tablet Chewable 500 MG (CalciumCarbonate Antacid) ,Carbidopa-Levodopa Tablet, Coumadin Tablet, Fiber formula, furosemide, gabapentin,Ins",COVID and pneumonia,"CHF, COPD, parkinsons, diabetes, hyperlipidemia, obstructive sleep apnea, hypertension, dilated cardiomyopathy, hyperparathyroidism",,Lisinopril,"['Chest X-ray abnormal', 'Diarrhoea', 'Hypoxia', 'Lung infiltration', 'Nausea', 'Pyrexia', 'Vomiting', 'White blood cell count normal']",1,MODERNA,IM 921830,PR,27.0,F,"Fever, chills, body aches, headache and abdominal pain. Took second dose yesterday, I was feeling fine and it all came back.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/15/2020,12/16/2020,1.0,PVT,no,no,no,,no,"['Abdominal pain', 'Chills', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 921832,SC,35.0,F,"Feeling of warmth, flushing, pruritic, eyelid swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,MIL,Montelukast 10 mg as needed for allergies Lidocaine topical patch prn,None,"obesity, dysmenorrhea",,"Shellfish, latex","['Feeling hot', 'Flushing', 'Pruritus', 'Swelling of eyelid']",1,PFIZER\BIONTECH,IM 921833,WA,54.0,F,large rash surrounding injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/03/2021,8.0,PVT,Naproxen OTC,None,"Asthma, not actively treated.",,"Grasses, penicillins, septra, sulfas",['Injection site rash'],1,MODERNA,IM 921834,CA,23.0,F,"left work early on 1/01/2021, feeling congestion, headache, cough, fever, chills, and body aches, tested for COVID-19 and is Positive",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,01/01/2021,9.0,PVT,,,,,,"['COVID-19', 'Chills', 'Cough', 'Headache', 'Pain', 'Pyrexia', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 921835,MD,50.0,F,"Received COVID moderna vaccine dose number 1 in left arm on 12/26/20. On 1/2/21 developed redness, swelling, warmth, to entire upper arm. 1/4/21 saw PCP for continued redness, swelling, warmth, and pain of entire left upper arm. PCP diagnosis: delayed vaccine reaction. Currently treating w/ ibuprofen, ice, and antihistamines. 1/5/21: Left upper arm improved but remains lightly red and swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,PVT,"Vitamin D3 10.000 units per day. Famotidine 20 mg once a day. Allegra 180 mg once a day. Metformin 1,000 mg once a day Rosuvastatin 5 mg once a day Valsartan 80 mg once a day Bijuva once a day",Chronic urticaria Type 2 diabetes,Type 2 diabetes Chronic urticaria,,Oral allergies: peaches and cantaloupe. Seasonal allergies. NKDA.,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 921836,CT,25.0,F,"Fatigue, chills, nausea, headache. Next morning, felt dizzy. Tried to get up. Sat at table, felt dizzy again, passed out, felt like she was deep sleep, was told she was foaming at the mouth. Felt better afterwards.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,"Calcium, Multivitamin, Fish Oil, Birth Control",no,no,,seasonal,"['Chills', 'Dizziness', 'Fatigue', 'Foaming at mouth', 'Headache', 'Loss of consciousness', 'Nausea']",1,MODERNA,IM 921837,MS,62.0,F,"Headache, dizziness, earache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Losartan, synthroid, Armour, norvasc, Xanax, Arimidex, citrucil, zinc, vitamin d, vitamin c,",None,"Breast cancer, hypothyroidism, high blood pressure",,Vancomycin,"['Dizziness', 'Ear pain', 'Headache']",1,PFIZER\BIONTECH,SYR 921838,,38.0,F,"itching and tingling in airway, throat, some shortness of breath",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,numerous medications,impetigo,"Factor V deficiency, chronic urticaria, MRSA positive",,over 50 allergies to food and drugs,"['Dyspnoea', 'Pharyngeal paraesthesia', 'Throat irritation']",1,MODERNA, 921839,,23.0,F,"Fever of over 101, chills, body aches. Treated with OTC ibuprofen. Symptoms resolved over the course of 48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,UNK,,,,,,"['Chills', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",UNK,MODERNA, 921841,CA,63.0,U,"15-30 minutes after the vaccine, patient developed tongue swelling patient was taken to ED and given IV Benadryl 50mg and symptoms resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/01/2021,01/01/2021,0.0,UNK,"atenolol, atorvastatin, metformin, hydrochlorothiazide",none,"HTN, DM, Sleep APnea, asthma",,"aspirin, betadine, lisinopril, penicillins class, tetracycline",['Swollen tongue'],1,PFIZER\BIONTECH,IM 921842,,26.0,M,Lips swelled and went numb. Hands swelled and went numb. Rash/redness covering upper body. Hives on arms. Nasal passages clogged,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/04/2021,5.0,WRK,,,,,Shellfish,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Lip swelling', 'Nasal congestion', 'Peripheral swelling', 'Rash', 'Urticaria']",UNK,PFIZER\BIONTECH, 921843,NJ,58.0,F,"Patient reports chills, joint and muscle aches, extreme fatigue, nausea, insomnia and a general sense of not feeling well.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,,,,,NKDA,"['Arthralgia', 'Chills', 'Fatigue', 'Insomnia', 'Malaise', 'Myalgia', 'Nausea']",UNK,PFIZER\BIONTECH,IM 921844,WA,38.0,F,HSV2 outbreak - took valcyclovir and acyclovir Hives? Or other rash,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/02/2021,9.0,PVT,,,,,"Shellfish, PCN",['Genital herpes'],UNK,PFIZER\BIONTECH, 921845,KS,28.0,M,"Tightness of chest, elevated heart rate, muscle and joint aches, fatigue, exhaustion, pain at injection site. No treatment sought as of yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,Adderall XR - 40 mg,None,"ADHD, exercise induced asthma",,Penicillin,"['Arthralgia', 'Chest discomfort', 'Fatigue', 'Heart rate increased', 'Injection site pain', 'Myalgia']",1,MODERNA,SYR 921846,NJ,61.0,F,NAUSEA AND HEADACHE,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,none,NONE,NONE,,NKA,"['Headache', 'Nausea']",2,PFIZER\BIONTECH,IM 921847,,18.0,F,Tongue felt ?tingly and weird?. Tongue was not swollen 25mg Benadryl po given. Pt left in private vehicle 98% o2 hr 72 Gait steady and without distress,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,"Maxalt, Zofran, albuterol","Asthma,anxiety, migraine",,,Omnicef,['Paraesthesia oral'],1,MODERNA,IM 921848,AR,40.0,M,"COVID vaccine Tuesday. Some soreness at the site that resolved over 2 days. Over the past 24 hours, developed some mild parasthesias [nonspecific]. Aren't painful, but tingling is annoying, contributed to restless night last night. Response 12/26: Acetaminophen, Start B-complex with Fe, report if not already done Chart 12/26: Reported. A bit better this am but will start vitamins Chart 12/29 [excerpt] Still having same symptoms of parasthesias. Started multivitamin as well as acetaminophen. I've noticed it affects only the right side of my body, and that it's purely sensory, no motor changes. Still mild, but not been sleeping well Responded, scheduled appt. � Vaccinated in L deltoid. Describes R side of body feels 'Cold' [dysesthesia] on R side of body and extremities. No weakness, no change in ROM. No joint swelling. No rash. Sensation feels less on R but still sense of touch. Thinks this is about the same- notices more when lies down in bed than in daytime. Symptoms persist 1/5/2021: Referred to Neurology at his request",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/24/2020,2.0,PVT,None,"Myopia, hemorrhoids. Restless legs (undiagnosed)",see #11,,None,"['Feeling cold', 'Full blood count normal', 'Injection site pain', 'Metabolic function test', 'Paraesthesia', 'Peripheral coldness', 'Restlessness', 'Sensory loss', 'Serum ferritin normal', 'Sleep disorder', 'Vitamin B12 normal']",1,PFIZER\BIONTECH,IM 921850,TX,25.0,F,"1 day after vaccine, redness and swelling occurred at injection site. Fever occurred. Redness and swelling continued x 1week after injection. Itching began on 1/4/21. Redness, swelling and itching continue to remain on 1/5/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,WRK,birth control pills,,,,NKDA No allergies,"['Injection site erythema', 'Injection site swelling', 'Pruritus', 'Pyrexia']",UNK,MODERNA, 921851,,16.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,UNK,was not age 18 at time of vaccination,,,,,['Unevaluable event'],1,MODERNA,IM 921852,TN,60.0,F,Still have slight fever Headache Fatigue Chills,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,ELMIRON CELEXA TYLENOL XANAX BUPROPION HCL XL SELENIUM VIT D2 CALCIUM CITRATE DOXYCYCLINE BUSPIRONE HCL EYE VITAMIN CAPS SYSTANE PROLIA INJ,EYE CHALAZION INTERSTITIAL CYSTITIS,OSTEOPOROSIS INTERSTITIAL CYSTITIS DEPRESSION,,PENICILLIN MORPHINE BENADRYL,"['Chills', 'Fatigue', 'Headache', 'Pyrexia', 'SARS-CoV-2 test']",2,MODERNA,IM 921853,TX,60.0,F,I felt prickly sensation on face. My voice became hoarse after 30 minutes and remained hoarse for about 5 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PHM,Nighttime Sleep-Aid containing diphenhydramine,none,none,"Shingrix caused me to have chills, fatigue",Bee strings,"['Dysphonia', 'Paraesthesia']",UNK,MODERNA,SYR 921854,,16.0,F,Patient under age 18 at time of vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PUB,was not 18 at time of vaccination,,,,,['Product administered to patient of inappropriate age'],1,MODERNA,IM 921855,MT,49.0,F,"Pt. observed for 30 minutes after vaccine. About 1hour after leaving area of vaccine observation she began to feel shortness of breath, tightness I throat, and throat felt full. I was informed about 1 hour after these symptoms had begun to develop. I advised to go to emergency room. Taken to ED by co-worker. Spoke with patient 1-5-2021. Returned to work today. Had severe joint pain, especially in left wrist that evening.. Still has achy joints and states she is exhausted.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PUB,"Insulin, Levothyroxin, gabapentin, Amlodapine, coreg (generic), effexor, Ibuprofen, Benadryl prn, Vitamin D supplement",none,"diabetic, hypertension, hypothyroid, high cholesterol",,"red chili pepper, cat dander","['Arthralgia', 'Dyspnoea', 'Fatigue', 'Throat tightness']",1,MODERNA,IM 921857,MI,79.0,F,"Malaise, Wobbly, T. 99.2",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,SEN,,,,,,"['Body temperature increased', 'Gait disturbance', 'Malaise']",UNK,MODERNA,IM 921860,IL,55.0,F,"GENERALIZED PAIN, CHILLS, HEADACHE",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,,NONE,"DM, HTN, ELEVATED CHOLESTEROL",,NONE,"['Chills', 'Headache', 'Pain']",1,MODERNA,IM 921861,MI,65.0,F,T. 102.3,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/03/2021,1.0,SEN,,,,,,['Body temperature increased'],UNK,MODERNA,IM 921862,OR,45.0,M,Patient started to have bilateral numbness in hands 15 minutes after vaccine. He was monitored for approx 30 minutes and never developed other symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,hypertension,,,['Hypoaesthesia'],1,MODERNA,IM 921863,RI,44.0,F,"Ee entered observation @ 1630. This nurse asked Ee if she was feeling okay around 1645. Stated she felt as if she had a ""lump in her throat"". Denied any type of SOB or breathing issues. @ 1650, Ee stated she felt an itching, burning, and tingling to her lips and chin. Ee also had mild edema noted to her lips. Also stated that she had onset nasal congestion. Benadryl 25mg given @ 1652. Ee remains @ observation @ present time, 1706. @ 1715 Ee stated that she had mild itching to entire body. Around 1720, stated that the symptoms were easing up. @ 1725, Ee stated that the symptoms were better, but slight itching still remained. Insisted on leaving observation, stated she was okay. Ee left observation @ 1726.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,"Dexilant, Cymbalta, Singular, Dyazide, Xyzal, Vit C, Zinc, Elderberry, Mag",,"GERD, Peripheral Neuropathy, Asthma, Allergies, HTC",,"Keflex, Levaquin","['Burning sensation', 'Lip oedema', 'Nasal congestion', 'Paraesthesia', 'Pruritus', 'Sensation of foreign body']",2,PFIZER\BIONTECH,IM 921864,NC,29.0,F,"Within 10 minutes following vaccine administration, patient had vomiting, lightheadedness, weakness, and verbalized feelings of being cold along with a very flushed appearance. Skin was slightly moist and very warm to touch. Complained she felt the same as when she was diagnosed with the coronavirus infection in March of 2020. Patient continued to experience ongoing weakness in all extremities, dizziness followed by complaints of some changes in her sense of the light with her eyes closed. Shortly thereafter patient began complaining of her heart ""speeding"" up. Medic arrived and transported patient to the local emergency room. On 1-2-2021 patient provided additional information including that later on the evening of the adverse event the arm where the injection was given became painful and itchy. Patient stated the pain and itching extended into Friday 1-1-2021 and then on into Saturday, 1-2-2021 she developed a sore throat, and some difficulty swallowing (described it as feeling something ""stuck"" in her throat) along with hoarseness. The patient also verbalized she remained weak, with a very sore arm and some small blisters which had formed on the same arm as where the injection had been given. A couple of the blisters the patient described where on the thumb of her hand as well her arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PUB,vitamins Pepcid sertraline acyclovir,none,none,,no known allergies,"['Asthenia', 'Blister', 'Cold sweat', 'Dizziness', 'Dysphagia', 'Feeling cold', 'Flushing', 'Full blood count', 'Heart rate increased', 'Injection site pain', 'Injection site pruritus', 'Laboratory test', 'Muscular weakness', 'Oropharyngeal pain', 'Pain in extremity', 'Skin warm', 'Visual impairment', 'Vomiting']",1,PFIZER\BIONTECH,IM 921865,PA,43.0,M,"Felt weak, dizzy, blurred vision and nausea Vitals normal except for several episodes of O2 stat 89-90. No wheezing . One dose of Diphenhydramine 25 mg dose. Back to normal in 1 hr.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,N/a,None,None,,N/a,"['Asthenia', 'Dizziness', 'Nausea', 'Vision blurred']",1,PFIZER\BIONTECH,IM 921866,MI,97.0,F,T. 100.2,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/03/2021,1.0,UNK,,,,,,['Body temperature increased'],UNK,MODERNA,IM 921867,KY,49.0,F,"I developed a small knot at the injection site the day after i received it. By the following evening it had grown to the size of a baseball. It was red, warm, indurated and it itched. Though when I attempted to scratch it was very painful. I took Benadryl on the evening January 2nd and have taken cetirizine for the past two days. It has gotten slightly smaller and the itching has improved though not completely resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,"Lexapro 10mg daily, wellbutrin 150mg daily, pepcid 20mg daily Vitamin C, Vitamin D, Super Vitamin B-complex, Zinc",None,"GERD, ADD",,None,"['Injection site erythema', 'Injection site nodule', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 921868,,45.0,F,"dizziness, flushing, chest tightness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,"lisinopril, escitalopram, atenolol, glyburide, rosuvastatin, metformin, insulin,",none,"diabetes, hypertension",,simvastatin,"['Chest discomfort', 'Dizziness', 'Flushing']",1,MODERNA, 921869,CA,34.0,F,"fever, chills, body aches, nausea, cough, COVID-19 tested on 1/02/2021 and came back Positive",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,,,,,,"['COVID-19', 'Chills', 'Cough', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 921870,WA,46.0,F,"Patient is a 46 y.o. female. Chief Complaint Patient presents with ? Allergic reaction � � allergic reation to covid vaccine � � Patient had a covid vaccine � Patient works for dermatology and cosmetic. The patient is a CMA Had filler injections on the face. Jaw line and Nasolabial folds on 12/29/2020 Juviderm and Define Resilin . Has had facial fillers for three to four years. No other implants or silicone in other body locations � No history of sulfa allergy No history of anaphylaxis. � About 120 after the Moderna vaccination, was in the car still in the parking lot got a flush feeling and got hot chest tightening, heart pounding. Weird taste in the month. Did not feel like she was going to vomit. Then got shaky. Face feels numb and swollen. Is not itchy. No hives. � Patient husband was driving, turned around And then pulled up. The RN on the observation deck gave EPI pen in the left thigh while she was still in the car. � � Driving home from getting Covid vaccine. Felt flushed, weird taste in mouth, chest tightening, palpitations, face swelling. � Is patient concerned about a specific cause for the current symptoms? Yes Covid vaccine Onset of symptoms: 2:25pm 1/3/2021. Symptoms include: hives, rash or generalized itching, throat or tongue tingling, itching, or swelling and facial swelling. Rash distribution: Face. How are symptoms changing over time? worsening. � Patient describes symptoms as severe. Has patient tried any treatment for these symptoms? Yes epi in left thigh What makes the symptoms better? Epi made breathing better What makes the symptoms worse? nothing � Associated symptoms: � o Fever No � o Sore throat No � o Recent illness No � o Exposure to person(s) with similar rash No � Objective: BP 106/72 | Pulse 77 | Temp 97.8 �F (36.6 �C) (Oral) | Resp 14 | SpO2 97% General:well-hydrated, well nourished, no acute distress HEENT: swelling where fillers have been used around the lips, nose, cheeks Neck: nontender, no masses Lung: clear to auscultation bilaterally Heart: regular rhythm, tachycardia noted and no murmurs, clicks, or gallops. Extremities: extremities normal, atraumatic, no cyanosis or edema Skin: flushed on face and neck and chest No urticaria No other rashes Neuro: alert, orientation normal, speech normal pupilary response normal bilaterally extraocular motions normal tongue midline no facial weakness or asymmetry we have pictures in her medical record. this appears to be a dermal filler reaction. the patient did receive epi as the first nurse who responded while she was in the car saw the facial eyelid swelling and redness and administered IM epi. Once we were able to move the patient into the clinic is was apparent that the person had no anaphylaxis symptoms. she was not itching, did not have hives, no stridor or wheezing or hypotension. she was discharge on a Medrol dose pack. advised not to get a second vaccine dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,unknown,Had filler injections on the face. Jaw line and Nasolabial folds on 12/29/2020 Juviderm and Define Resilin . Has had facial fillers for three to four years. No other implants or silicone in other body locations. she has had Botox in the past on her face.,none known,,Unknown,"['Blood catecholamines', 'Catecholamines urine', 'Chest discomfort', 'Condition aggravated', 'Dyspnoea', 'Erythema of eyelid', 'Flushing', 'Full blood count', 'Histamine level', 'Hypoaesthesia', 'Nervousness', 'Palpitations', 'Paraesthesia oral', 'Pharyngeal paraesthesia', 'Pharyngeal swelling', 'Pruritus', 'Rash', 'Serum serotonin', 'Skin reaction', 'Swelling face', 'Swelling of eyelid', 'Swollen tongue', 'Taste disorder', 'Throat irritation', 'Tongue pruritus', 'Tryptase', 'Urticaria']",1,MODERNA,IM 921871,MI,77.0,F,T.102.9 upset stomach,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/03/2021,1.0,SEN,,,,,,"['Abdominal discomfort', 'Body temperature increased']",UNK,MODERNA,IM 921872,AK,66.0,F,"Patient was experiencing headache, lightheadedness, generalized itching, shortness of breath, wheezing, and nausea after 8-10 minutes of COVID-19 vaccine administration. Vital signs were stable RR 22 and SpO2 96% on RA. She was speaking in full sentence, no acute distress, with expiratory wheezing. No central cyanosis or new rash. After 15 minutes, she reports improvement on her symptoms. She was given Benadryl po and Albuterol 2 puffs in the clinic with improvement on her symptoms. Lungs have more air movement and less wheezing after the albuterol treatment. She was send home and educated in ED precautions.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,,,,,Ampicillin and penicillin.,"['Dizziness', 'Dyspnoea', 'Headache', 'Nausea', 'Pruritus', 'Wheezing']",1,PFIZER\BIONTECH,IM 921873,MN,26.0,M,"Developed slight nausea about 10 minutes after vaccine administered. Started having sensitivity to light, lightheaded, dizzy, sweaty/clammy then dry heaves.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PUB,,"Fell on sidewalk on 1/3/21, did not hit his head.",Seizure disorder vascular brain tumors,,Unknown,"['Blood pressure increased', 'Cold sweat', 'Dizziness', 'Hyperhidrosis', 'Nausea', 'Photophobia', 'Retching']",2,MODERNA,IM 921874,CA,25.0,F,"Malaise, feverish, joint pain, muscle ache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Vitamin C 1000mg, Flonase, Singulair 10mg, Vitamin D3, Women multivitamin, Emergen-C diet supplement",Covid + on 12/10/20,,,,"['Arthralgia', 'Malaise', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 921875,MI,80.0,F,Itching and redness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/05/2021,3.0,SEN,,,,,,"['Injection site erythema', 'Injection site pruritus']",UNK,MODERNA,IM 921876,IA,30.0,F,"Painful, red, puffy/swollen at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PHM,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Skin swelling']",1,MODERNA,IM 921877,IL,36.0,F,Patient experienced redness and hives on neck and face area with itching. Applied Ice to neck area and administered 50 mg of Benadryl PO at 2pm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,,,,"['Erythema', 'Pruritus', 'Urticaria']",1,MODERNA,IM 921878,LA,57.0,F,"Took vaccine and was monitored for 30 minutes. She left the area and went on to her duties. Approximately 1 hour later, she reports noticing a hot flushing sensation starting at the top of her head. It gradually was going down to include her face and back upper body. She notice splotching of her skin large half dollars size on her front of her body. Smaller red spots on the back. There was a clear line of demarcation at her breast line around to her back. No SOB or respiratory issues. Went home and took a 50 mg. Benedryl. The rash has lightened at this time 16:32 PM same day of vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,Caduet,None,Hypertension and high cholesterol,,Sulfa in the past.,"['Erythema', 'Hot flush', 'Rash macular']",,MODERNA,IM 921879,UT,28.0,F,"Patient received a Covid vaccine and instructed to wait 30 minutes before leaving facility. A few minutes later patient started c/o swelling in throat, difficulty breathing and being hot and flushed.1600: Pt was moved to a quiet space, BP was 146/83 HR 93 RR 20. 911 was called. 1604: Epinephrine injection given in right thigh. 1606: BP 175/74, HR 94 RR 20. EMS arrived at 1610. 1611 2nd dose of Epinephrine given in left thigh, per direction from EMS. Client continued to c/o shortness of breath and ""throat closing off"". EMS took over care at 1612, transferred to Hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PUB,Unknown,Unknown,Unknown,,"Metformin, mushrooms","['Dyspnoea', 'Feeling hot', 'Flushing', 'Pharyngeal swelling']",1,MODERNA,IM 921880,VA,96.0,M,"The resident was found deceased a little less than 12 hours following COVID vaccination, and he had had some changes over the last 2 days. He was 96 and had been on hospice care for a little while. Noone noticed any side effects from vaccine after it was given",Yes,01/02/2021,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,SEN,"Olanzapine, polyethylene glycol, ativan, morphine, senna",was under hospice care,"alzheimers disease, ataxia, HTN, Kidney malignancy history, Prostate cancer history, GERD, sleep apnea, history falls",,oxycodone,['Death'],1,PFIZER\BIONTECH,IM 921881,TX,35.0,M,Severe chills (heater turned to 80 F); no fever headache malaise widespread body aches nausea lightheadedness/dizziness ongoing not alleviated by APAP or ibuprofen,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,,,htn,,nkda,"['Chills', 'Dizziness', 'Headache', 'Malaise', 'Pain']",2,PFIZER\BIONTECH,IM 921882,GA,40.0,F,"Hives, wheezing,SOB,itching, Tingling in tongue initially. 01/05/2021 Fever 100.8, headache and joint pain Treated with Albuterol inhaler and Benadryl 25mg x2",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Albuterol inhaler, Vit D , Xyzal, Singular",none,"HyperIGE syndrome,asthma","due to hyperige syndrome, typically has adverse effects including hives, fever, joint pain, headache, itching , SOB,wheezing","Sulfa, Vit B 12 injections","['Arthralgia', 'Dyspnoea', 'Headache', 'Paraesthesia oral', 'Pruritus', 'Pyrexia', 'Urticaria', 'Wheezing']",1,PFIZER\BIONTECH,IM 921883,FL,49.0,F,"Site pain and itching the 1st 48hrs. Headache, nausea,vomiting, site pain,swelling,redness,itching after day 6. No medications used.025J20A",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,OTH,Tylenol,No,No,,No,"['Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Nausea', 'Vomiting']",1,MODERNA,SYR 921884,IL,80.0,F,"NAUSEA, DRY MOUTH, HEADACHE",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,"Ferrous Sulfate, Atorvastatin Calcium, Fluconazole Tablet, PreserVision AREDS 2 Capsule, Eliquis Tablet, Vitamin D3 Tablet, Acetaminophen Tablet 500, dilTIAZem HCl Tablet, Levothyroxine Sodium Tablet, Sertraline HCl Tablet",,"CHRONIC DIASTOLIC (CONGESTIVE) HEART FAILURE, PAROXYSMAL ATRIAL FIBRILLATION, CARDIAC ARRHYTHMIA, HTN, HLD, IRON DEFICIENCY ANEMIA, HYPOTHYROIDISM",,"Ceftriaxone, Benadryl, Betadine","['Dry mouth', 'Headache', 'Nausea']",1,MODERNA,IM 921885,,41.0,M,Swollen Lymph Nodes,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/05/2021,3.0,OTH,,,,,,['Lymphadenopathy'],1,PFIZER\BIONTECH, 921886,NE,52.0,M,DEVELOPED PAIN IN ARM AND NAUSEA,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,,,,,,"['Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 921887,CA,32.0,M,"01/04/21: soreness in the injection area (deltoid) 01/05/21: soreness continues in the injection area - specifically if deltoid is contracting to hold the arm out. If arm is supported (by a table for example), deltoid is not reacting. In the morning, everything felt fine but by early afternoon, feelings of fatigue/soreness in other parts of the body has occurred.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,,,,,,"['Fatigue', 'Injection site pain', 'Pain']",1,MODERNA,IM 921888,NY,60.0,F,"1555-pt reports left sided facial numbness/tingling, heat sensation to her left ear. Face appears flushed, respirations even and regular. BP 145/75 HR 79 RR 20. Denies any swelling, or respiratory distress 1600-Benadryl 50mg PO and Prednisone 40 mg PO given per medical directory. Pt tolerated well. BP 130/81 HR 79 RR 20 1610-no changes BP 130/89 HR 79 RR 20 1630-pt reports only mild facial tingling near left eyebrow, facial flushing improving. continues to deny any respiratory distress, denies any difficulty swallowing. BP 145/79 HR 78 RR 18. pt advised to have s/o pick her up and to f/u with emergency department or PCP. Reported understanding.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,Occasional OTC Aleve,None,Hypothyroidism,,NKDA,"['Flushing', 'Hypoaesthesia', 'Paraesthesia', 'Skin warm']",1,MODERNA,IM 921889,CA,30.0,M,"body aches, nasal congestion, loss of taste & smell, diarrhea, shortness of breath, tested 01/04/2021 for COVID-19 and results are Positive",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/31/2020,2.0,PVT,,,,,,"['Ageusia', 'Anosmia', 'COVID-19', 'Diarrhoea', 'Dyspnoea', 'Nasal congestion', 'Pain', 'SARS-CoV-2 test positive']",1,MODERNA,IM 921890,CA,62.0,F,fatigue chills arm soreness,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,,,,,,"['Chills', 'Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 921891,IL,80.0,F,"NAUSEA, DRY MOUTH, HEADACHE",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,"Ferrous Sulfate, Atorvastatin Calcium, Fluconazole Tablet, PreserVision AREDS 2 Capsule, Eliquis Tablet, Vitamin D3 Tablet, Acetaminophen Tablet 500, dilTIAZem HCl Tablet, Levothyroxine Sodium Tablet, Sertraline HCl Tablet",,"CHRONIC DIASTOLIC (CONGESTIVE) HEART FAILURE, PAROXYSMAL ATRIAL FIBRILLATION, CARDIAC ARRHYTHMIA, HTN, HLD, IRON DEFICIENCY ANEMIA, HYPOTHYROIDISM",,"Ceftriaxone, Benadryl, Betadine","['Dry mouth', 'Headache', 'Nausea']",1,MODERNA,IM 921892,NY,43.0,F,Moderna COVID-19 Vaccine EAU,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,B6 D3 L-Theanine Bacopa Monnieri,,,"Flu shots: give me flu like symptoms, <38y/o, do not remember details",,['Unevaluable event'],1,MODERNA,SYR 921893,,45.0,F,swelling at injection site 9 days after administration of vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,UNK,,,,,,['Injection site swelling'],1,MODERNA,IM 921894,NE,87.0,M,DEVELOPED FATIGUE,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,SEN,,,,,,['Fatigue'],1,PFIZER\BIONTECH,IM 921896,,52.0,F,"tingling lips, no swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,none,none,none,,none,['Paraesthesia oral'],1,MODERNA, 921897,IL,39.0,F,I began experiencing tachycardia and numbness in my hands and feet.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/19/2020,2.0,PVT,Melatonin,None,None,,None,"['Electrocardiogram ambulatory', 'Hypoaesthesia', 'Laboratory test', 'Tachycardia']",1,PFIZER\BIONTECH,IM 921898,RI,59.0,F,"after the vaccine on the 19th I woke up with a bad headache and sore throat, not intense I just felt like I was getting sick I took Motrin, Over the weekend I had significant heart beating which was very out of the ordinary I saw my physician. It felt anaphylactic. Dr did not prescribe anything I was asked to watch my symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,no,no,no,,no,"['Anaphylactic reaction', 'Headache', 'Heart rate increased', 'Malaise', 'Oropharyngeal pain']",1,PFIZER\BIONTECH,SYR 921899,MD,46.0,F,Flulike symptoms . Tested positive for covid-19,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PUB,Flulike symptoms and tested positive for Covid-19 on 1/4/20,NO,NO,,NKDA,"['COVID-19', 'Influenza like illness', 'SARS-CoV-2 test positive']",1,MODERNA,IM 921900,VA,39.0,F,"I have not been able to sleep or rest since getting the vaccine. My body feels like it is racing like on lots of caffeine. That speedy feeling. I have the normal side effects as well, headache, nausea, fatigue...",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,Protonix and multi vitamin,None,None,,"Nuts, Claritin, Percocept","['Fatigue', 'Feeling abnormal', 'Feeling jittery', 'Headache', 'Nausea', 'Sleep disorder']",1,MODERNA,SYR 921901,IL,54.0,F,"About 49 hours after receiving the Pfizer mRNA COVID-19 vaccine, patient developed chest tightness, itchy throat, upper and lower eyelid swelling, lip swelling, difficult swallowing. Selt-treated with prednisone 40mg, fexofenadine 1 tablet, famotidine 40mg, albuterol breathing treatment. Felt better, but then 6-8 hours later, felt chest tightness again that did not resolve with breathing treatment. Went to the Hospital Emergency Department. No epinephrine was administered. But received IV corticosteroids, diphenhydramine and famotidine, and was discharged with 6 days of oral corticosteroids",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/19/2020,2.0,PVT,"Aspirin - started 6-7 years Atenolol - at least 2 years Estradiol vaginal cream - at least 6 months Eszoclopizone - at least 5 years Ketorolac as needed for at least 3 years ago. Denies having taken it on Dec 17th, 18th, 19th or the week pr",Denies,Cough Variant Asthma Allergic Rhinitis to Dust mite and Mold s/p 10 years of SCIT Hypothyroidism Migraine Vitamin D deficiency Multiple drug intolerances,,Medrol injections to the knee and SI joint ; developed hives 1 to 3 days after getting the injection Kenalog injections to the knee and SI joint; developed hives 1 to 3 days after getting the injection Hives resolved after she stopped getting the knee and SI joint injections Golyte prep - reports had a rash a few days after taking Golyte prep 15 years ago.,"['Chest discomfort', 'Dysphagia', 'Lip swelling', 'Swelling of eyelid', 'Throat irritation']",UNK,PFIZER\BIONTECH,IM 921902,CT,23.0,F,"Tingling and numbness of tongue, throat and lips Facial and neck itch and redness Minimum difficulty breathing",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,None,Covid,None,,Almonds Hazelnuts Brazil nuts Soy Apples Peaches Pears Nectarines Plums Cherries,"['Dyspnoea', 'Erythema', 'Hypoaesthesia oral', 'Paraesthesia oral', 'Pharyngeal hypoaesthesia', 'Pharyngeal paraesthesia', 'Pruritus']",1,PFIZER\BIONTECH,SYR 921903,MA,50.0,F,8:31 Reported to us increased heart rate and tingling lips. Stated she had several allergies and brought her epi pen with her. Brought her to EMS station. 8:32 Gave epi 8:35 HR126 SPO2 100% 8:38 IV placed 8:39 POC 108 8:39 Benadryl 50mg IV push 8:40 Solumedrol 125 mg IV push Continued tongue/throat/ head itching 8:42 second epi given 8:46 136/64 HR 125 8:48 Transported to Medical Center via EMS,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,WRK,"Adderall, Zoloft, Trazodone",,None reported,Needed Benadryl after flu shot in October,"Bee stings, Sulfa, Amoxicillin, Codeine, Morphine, Toradol, Dilaudid, Demerol","['Heart rate increased', 'Paraesthesia oral', 'Pruritus', 'Throat irritation', 'Tongue pruritus']",1,PFIZER\BIONTECH,IM 921904,OH,38.0,F,"Received vaccine on 1/4@1530. Around 8pm soreness in left arm started worsening throughout night. When I woke up on 1/5/21@0445am for work I had a low grade fever of 100.5, headache, muscle aches all over body, chills, fatigue, joint pains all over. Around 0700am I developed weakness, dizziness and nausea with the other symptoms throughout the rest of the day. Took Tylenol and rested but woke up feeling the same at 4pm. Took my temperature at 5pm which was 100.00. Attempted to call vaccine information line but they closed at 5pm and left voicemail message with VAERS.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,"Mono-Linyah 0.25-35 Tab birth control, 2 Tylenol extra strength and 2 Ibuprofen later on when experiencing side effects.",None,None,,NKDA,"['Arthralgia', 'Asthenia', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 921905,CA,59.0,F,"Patient reports feelings tiredness, body aches and chills within 24-38 hours of vaccination. Patient report just feeling very tired.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,Daily Medications,,,,,"['Chills', 'Fatigue', 'Pain']",UNK,MODERNA, 921906,NV,36.0,F,"1/4/21 Developed redness, swelling, raised, rash, itchy, size of quarter area. 1/5/21 Redness increased to 2 inches by 2.5 inches with same symptoms. Reported to Employee Health refer to Urgent Care.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,"Zinc, vitamin D, Pro-biotics, Multivitamin",None,None,,none,"['Erythema', 'Pruritus', 'Rash papular', 'Swelling']",1,MODERNA,IM 921907,AR,25.0,F,sore arm with rash/redness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,SEN,unknown,unknown,unknown,,unknown,"['Erythema', 'Pain in extremity', 'Rash']",UNK,MODERNA,IM 921908,NY,62.0,M,"Chills, body aches, mild headache, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Levothyroxine,None,Hypothyroid,,No,"['Chills', 'Fatigue', 'Headache', 'Pain']",1,MODERNA,IM 921909,AK,66.0,F,Left arm painful with redness and firmness around the injection area. Pt also has round bulging birthmark above it that was also red. It started 24 hours after the injection and it is now Day 2 after the injection and still there. We treated it with benadryl/ hydrocortisone cream/ hot packs/ and ibuprofen. She had one dose of cephlexin.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/04/2021,1.0,OTH,"levothyroxine , ben gay cream",none,hypothyroidism - pt did have a bubble birthmark on that arm. but there is hardness adn redness around the injection site.,,none,"['Injection site erythema', 'Injection site induration', 'Pain in extremity']",1,MODERNA,IM 921910,NE,85.0,F,DEVELOPED DIARRHEA THE DAY AFTER INJECTION.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,,,,,,['Diarrhoea'],1,PFIZER\BIONTECH,IM 921911,CO,52.0,F,"Employee got COVID vaccine on 1/2/2021. She was awoken at 0400 AM that night with extreme chills, shivering. Fever 102.5 on Sunday, fatigue and body aches. Localized pain at injection site. Yesterday she felt better. Highest temp yesterday was 101.5. She noticed redness and swelling on Sunday and this morning she noticed it is larger-swelling and redness the size of a silver dollar that is hot to the touch. She is unsure of her temperature today and does not feel febrile today. She does not feel well today-feels body aches and general malaise. Her arm is painful, 5/10, and radiates up into shoulder and neck and causing a headache. Her right jaw was painful on Sunday and Monday. If she applied pressure to her jaw the pain would subside. Reports diarrhea Sunday into Monday that has since subsided. Employee reports being diagnosed with COVID on 11/15/2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/03/2021,1.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Chills', 'Diarrhoea', 'Erythema', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Neck pain', 'Pain', 'Pain in jaw', 'Pyrexia', 'Skin warm', 'Swelling']",1,MODERNA,IM 921912,TX,31.0,F,"At 1020 patient c/o feeling hot, sore throat w/difficulty swallowing, dizziness & lightheadedness. BP 144/98, P 77, R 20, SpO2 99%. At 1025 c/o sm. amt. of chest pain, numbness to tongue& no longer feels hot. BP 144/84, P 76, R 20, SpO2 100%. At 1029 Gave pt. Benadryl 50mg oral solution as directed by doctor. Doctor assessed patient. Pt. c/o of increase in chest pressure, numbness to left side of face. At 1036 BP 130/85, P 82, P 20, SpO2 100%. At 1042 BP 123/85, P 84, R 20, SpO2 100%. Chest pressure continues @ 4/10 on Wong pain scale. Continues w/throat pain & numbness to (L) side of face, the dizziness has lessened. At 1053 BP 118/80, P 72, R 20, SpO2 100%. Reports chest pressure is gone No change in other symptoms & is lightheaded. At 1055 pt. pt. to have coworker to drive her back to clinic w/pt.?s dad meeting them to take pt. home/ER. At 1100 Pt. very dizzy and not feeling well upon standing. Pt. agreed w/nurse to have EMS assessment. EMS notified to respond. At 1115 BP 123/77, P 76, R 20, SpO2 100%. Throat remains and (L) side of face numb, cont. to feel lightheaded. EMS on site @ 1119 to evaluate patient. At 1126 pt. transported to ER via EMS.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PUB,unknown,reports positive COVID19 test on 12/16/2020.,no,,Tivan,"['Chest discomfort', 'Chest pain', 'Dizziness', 'Dysphagia', 'Feeling hot', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Malaise', 'Oropharyngeal pain']",1,MODERNA,IM 921913,AK,50.0,U,"At 1602 client began c/o numbness on L side of face and pain/tension in L side of neck, radiating down L arm. Vitals remained stable, no swelling or paralysis noted. No change in mentation, hives or difficulty breathing. Monitored until 16:39. At that time there was no change in her condition. Agreed to return home-monitor for worsening condition, seek medical care if worsens or continues. Treat symptoms with OTC and heat. Followed up with client 1/5. Reports took ibuprofen in pm and again this am to assist with pain and swelling. Still some swelling in face but resolving. No further symptoms appeared.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,"citalopram, Sudafed, Zyrtec, Flovent, vitamin D",,"mild asthma, general anxiety",,"PCN, emycin, environmental","['Hypoaesthesia', 'Neck pain', 'Pain', 'Pain in extremity', 'Tension']",1,PFIZER\BIONTECH,IM 921914,PA,79.0,M,"Episode of vomiting, change in mental status, hypoxia and seizure activity.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,N/a,None,"Epilepsy, CKD, status post CVA, type 2 diabetes. Traumatic brain injury",,Beef and tomato,"['Hypoxia', 'Mental status changes', 'Seizure', 'Vomiting']",1,PFIZER\BIONTECH,IM 921915,TN,93.0,F,Patient had Osats down to 80 around 20mins after vaccination with pulse upwards of 130. Gave patient 3-4L of O2. Patient did not respond and so epinephrine administered. EMS called. Patient's Osat was around 90 with pulse ranging from 80-120 after EMS arrived and consent received from family.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,SEN,UNKNOWN,"HTN, HEART DZ","HTN, HEART DZ",,NONE PROVIDED,"['Heart rate increased', 'Oxygen saturation decreased']",1,MODERNA,IM 921916,ME,27.0,F,"Tingling sensation in the tongue, high BP",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Birth control, albutrol",,,,,"['Hypertension', 'Paraesthesia oral']",2,PFIZER\BIONTECH,IM 921917,CA,,U,"Edit to Vaccine Excursion Report ID 55197 filled on 12/29/2020 At 845 am on 12/28/ 2020, Moderna, Covid 19 vaccines, arrived at Health Care Center. Vaccines were placed into Immunization Freezer at temperature range of -5.6 F at 830 am. At 845 am freezer temperature noted at 4.3,12.0 10.2 F from 9 am to 930 am. At 945 am temperature was noted at 3.9 F. During the 30-minute temperature rise, vaccine protocol was followed, and a sign was placed on freezer by Lead RN to not use and to not open freezer. Emergency safety protocol were acted to ensure the viability of all vaccines. Staff nurse filed a vaccine excursion report on 12/29/2020 with VFC program and incident report. The case content information, on case number #01832359 per Merck vaccine,? ok to use,? and questioned the nature of the caller?s excursion report. Moderna vaccine case number MOD20-2372 up to the health officer and provider. Unknown nature of outcome. As this has yet to be determined.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,PHM,none,none,none,,none,['Product storage error'],1,MODERNA,IM 921918,NE,75.0,F,"DAY AFTER VACCINATION, DEVELOPED SORE/SCRATCHY THROAT",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,,,,,,"['Oropharyngeal pain', 'Throat irritation']",1,PFIZER\BIONTECH,IM 921920,MI,40.0,F,"Within 10 minutes of receiving the vaccine patient began to look sleepy and started to gasp for breath. She called for help and slouched over in a chair and was moved to lay on the floor. Her feet were elevated and 911 was called. Epinephrine was given, patient responded by being able to gasp for breath and her face returned to a more natural state. Within 5 min she began to struggle to breath and epi was given again. Some improvement did occur. EMS arrived and she was taken to the hospital.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/05/2021,01/05/2021,0.0,SEN,None known,None listed,None listed,,None listed,"['Dyspnoea', 'Oxygen saturation decreased', 'Posture abnormal', 'Somnolence']",1,MODERNA,IM 921921,PR,41.0,F,"Chills, fever, general malaise, headache, fatigue, ?electric-like? shots all over head",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/04/2021,3.0,WRK,,Mixed connective tissue disorder,,,Strawberry Olives Salm�n Pepper,"['Chills', 'Fatigue', 'Headache', 'Malaise', 'Pyrexia', 'Shock symptom']",2,PFIZER\BIONTECH,IM 921922,NV,43.0,F,"Redness, swelling, warm to the touch and hard. pain upon touching and pain in arm pit is very tender. Lymph node.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PUB,Taken a motrin prior and after. BP meds lasartin,denies,high blood pressure,,"amoxicillin, latex","['Axillary pain', 'Erythema', 'Induration', 'Skin warm', 'Swelling']",1,MODERNA,IM 921923,AZ,44.0,F,Tingling of top lip with mild swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,None,None,None,,None,"['Lip swelling', 'Paraesthesia oral']",UNK,PFIZER\BIONTECH,IM 921924,,57.0,F,"tingling in her tongue, chest tightness. Given 10ml Benadryl Tingling and tightness subsided left with HR 75 BP: 130/80",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,,,Asthma,,"PCN, Arythro, Mango, Walnuts, C-Clor","['Chest discomfort', 'Paraesthesia oral']",1,MODERNA,IM 921925,CA,33.0,F,"loss of taste & smell, nasal congestion, got tested for COVID-19 on 1/04/2021 and it was Positive",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/31/2020,8.0,PVT,,,,,,"['Ageusia', 'Anosmia', 'COVID-19', 'Nasal congestion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 921927,UT,32.0,M,numbness to arm to fingers burning to wrist,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PUB,Warfarin,ST. Jude Aortic Valve,Asthma,,Pets,"['Burning sensation', 'Hypoaesthesia']",1,MODERNA,IM 921928,MA,53.0,F,"Pt C/o Red itchy rash on face , Chest and Blotchy rash on hands. Denied SOB. Had same reaction in 2001 from Flu Shot. Gave PT 25 mg Benadryl PO and Pt stayed with Husband who is an MD until sx were improving. Pt Left with Husband when she stated her sx were improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,WRK,Zyrtec daily at bedtime Allegra,,,"Similar reaction of red itchy rash on face, chest, and blotchy rash on hands back in 2001 from flu shot",PCN - rash,"['Rash', 'Rash erythematous', 'Rash macular', 'Rash pruritic']",1,MODERNA,IM 921929,CA,51.0,F,"Localized redness, swelling, itching at injection site on Day #7-9",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/02/2021,7.0,PVT,none,none,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA,IM 921930,AR,27.0,F,"I had normal side effects at first. But this morning at work,(a week after vaccine), where I had the injection from the vaccine is red, swollen, and itchy. I spoke with my dr and he said it may be an allergic reaction to the vaccine and told me to report it here.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,SEN,none,none,none,,"amoxilcillin, penicillin, sulfa drugs","['Hypersensitivity', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA, 921931,ME,52.0,F,Tightness in the chest and neck,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Sertraline, Prilosec",,,,None,"['Chest discomfort', 'Muscle tightness']",1,MODERNA,IM 921932,CA,40.0,F,Developed headache and backpain within 5 minutes from vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,none,none,none,,nka,"['Back pain', 'Headache']",1,PFIZER\BIONTECH,IM 921933,AR,29.0,F,sore arm with rash/redness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,UNK,unknown,unknown,unknown,,unknown,"['Injection site erythema', 'Injection site pain', 'Injection site rash']",UNK,MODERNA,IM 921934,AZ,41.0,M,Left sided pleuritic chest pain developed about 24 hours after vaccination and continued to get worse for 2 days after which it is now slowly resolving. Used ibuprofen and tylenol PRN to help with pain symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,Omeprazole 40 mg po once daily,None,Arytenoid granuloma,,Penicillin and sulfa,"['Blood urea normal', 'Chest X-ray normal', 'Chest pain', 'Electrocardiogram normal', 'Fibrin D dimer normal', 'Full blood count normal', 'Metabolic function test normal', 'Pleuritic pain', 'Troponin T normal']",1,MODERNA,IM 921935,,39.0,F,"Employee was feeling fatigued on Mon, 1/4. By Tuesday afternoon while at work, she was experiencing body aches and ""felt my heart racing."" She was sent to the ER by her supervisor and her SBP was 180s and HR was 120s. Employee does not have a hx of HTN or heart conditions.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Fatigue', 'Pain', 'Palpitations']",2,PFIZER\BIONTECH,IM 921936,NY,33.0,F,A week after receiving the COVID vaccine(Moderna) I started developing a red rash on my upper arm surrounding the injection site. The rash has continued to spread in that area since yesterday.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/04/2021,7.0,PVT,Amitriptyline,None,"Celiac disease, migraines, IBS",,Wheat/gluten allergies(celiac disease),"['Injection site reaction', 'Rash erythematous']",1,MODERNA,IM 921937,CO,44.0,F,"Headache, lethargy, body aches for 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/02/2021,1.0,PVT,"Xyxal, Vyvanse",None,Asthma ADD,Tetanus as a baby and teenager. Have received a tetanus booster as an adult with no adverse event,Environmental allergies Have had a history of unusual reactions to medications but have never had an anaphylactic reaction.,"['Headache', 'Lethargy', 'Pain']",1,PFIZER\BIONTECH,SYR 921938,PA,60.0,F,"Started with a cough 24 hours afterwards and then 48 hours started with body aches, head congestion;, chills and extreme fatigue. Tested positive for COVID 1 week after received the vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,Requip,None,HHT- nose bleed,,,"['COVID-19', 'Chills', 'Cough', 'Fatigue', 'Pain', 'SARS-CoV-2 test positive', 'Sinus congestion']",1,MODERNA,IM 921939,UT,57.0,F,"Patient received a Covid vaccine in right arm. Patient started c/o eye swelling, tingly nose, itchy mouth. 1108: BP 146/118 RR 16 HR 105 O2 98, starting to cough, eye swelling increased. 1112: Epinephrine 0.3 mg auto injector given in left thigh, EMS called. 1115:BP 162/112, RR 28, HR 121 O2 98, Pt states feeling better. Within 3 mins Pt started to c/o itchy throat and mouth, starts dry coughing. 1120: BP 158/112 RR 28 and labored HR 142 O2 98 2nd dose of Epi given in left thigh. Started O2 and bag valve. 1122: EMS arrived assessed client, albuterol given and transported to hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PUB,Unknown,Unknown,Unknown,Flu vaccine in 1972,"Penicillin, Sulfa, Erythromycin, Nasocort, Singulair","['Cough', 'Dyspnoea', 'Eye swelling', 'Oral pruritus', 'Paraesthesia', 'Throat irritation']",1,MODERNA,IM 921940,AR,35.0,F,sore arm with rash/redness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,SEN,unknown,unknown,unknown,,unknown,"['Injection site erythema', 'Injection site rash', 'Pain in extremity']",UNK,MODERNA,IM 921942,GA,32.0,F,"12/28 8am- Pfizer vaccine (lot#EL0140) received in L arm at Hospital 12:45pm- out on a walk. Lightheaded, fatigue, chills, mild nausea, stomach cramping, and muscle weakness all hit pretty hard at once. Notice slight arm soreness as well. Went back inside and essentially collapsed on the couch 5:30pm- Arm soreness is worse. Chills and lightheadedness only mild now. Fatigue has gone down to where I can resume daily activity 12/29 Wake up with moderate sore throat Stabbing arm soreness at injection site Moderate fatigue and nausea persist. Mild chills. Tried to go for a walk outside and found a 30 minute very slow walk extremely tough 12/30-1/2 Moderate sore throat continues. Other symptoms gone 1/1-2 Arm/ injection site soreness slowly fades 1/2: exercise for the day= 70 min yoga and 7.5 miles of walking. Had a couple glasses of wine at dinner (possibly relevant if issues with vaccine are related to high histamine food issues) 1/3 Moderate headache, fatigue, and muscle aches. Skin feels hot. Sore throat worse than the previous days. Mild runny nose. Severe nausea. Go to Urgent care for COVID test and Zofran Rx. COVID rapid test and PCR test both negative. No fever, higher than usual blood pressure 1/4-5 (current) Nausea lower but still moderate, requiring Zofran. Sore throat persists. Mild fatigue and muscle aches. Skin still feels warm. Mild vertigo during exercise",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,"Cryselle, Allegra, Cymbalta, Flonase, Vitamin C, Magnesium, Quercetin Bromelain, CBD extract",Very mild respiratory virus (tested negative for covid) started 11/29,"anxiety, egg and dairy intolerance suspected mast cell/histamine processing issue",,morphine (rash reaction),"['Abdominal pain upper', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Muscular weakness', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Pain in extremity', 'Rhinorrhoea', 'SARS-CoV-2 test negative', 'Skin warm', 'Vertigo']",1,PFIZER\BIONTECH,IM 921943,FL,41.0,F,"Developed shingles on 12/23/20- went to urgent care on 12/24/20, was given Prednisone and Acyclovir prescriptions. Rash sites dried on 12/28/20.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/23/2020,7.0,UNK,"Centrum multivitamin, Vit D, Biotin",none,none,,No,['Herpes zoster'],1,PFIZER\BIONTECH,IM 921944,MA,64.0,F,Feeling of itchy throat and coughing then started. Evaluated by EMT Gave 25 mg po Benadryl at 3:02PM.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,WRK,"Singulair, Zyrtec, Vitamin D, Bioten, Occuvite, Lexapro",,,,"Compazine, Erythromycin, Forteo","['Cough', 'Throat irritation']",1,MODERNA,IM 921945,WA,52.0,M,Patient reported dizziness (vertigo) that lasted nearly 12 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,"Montelukast, albuterol inhaler",intermittent vertigo,None,,Hay fever,"['Dizziness', 'Vertigo']",1,MODERNA,IM 921946,TX,27.0,F,Sudden and continuous heartburn on 12/20/2020 which lasted all day. Took Lansoprazole on 12/20 and 12/21. Symptom resolved on 12/21.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/20/2020,2.0,PUB,"- Sertraline 100 mg, oral, tablet, once a day - Bupropion 150 mg, oral, tablet, once a day",No,No,,No known allergies,['Dyspepsia'],1,PFIZER\BIONTECH,IM 921947,AR,37.0,F,sore arm with rash/redness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,SEN,unknown,unknown,unknown,,unknown,"['Injection site erythema', 'Injection site pain', 'Injection site rash']",UNK,MODERNA,IM 921948,CO,35.0,M,"Employee got COVID vaccine to right arm 12/21/2020. He noticed a rash to his right arm on the night of 12/27/2020. The rash was red and raised, he didn't think anything of it at the time. The rash persisted and was growing in a linear fashion and seemed to have an unusual appearance. He scheduled a telehealth visit with a Hospital Urgent Care on 12/31/2020. At this time he was diagnosed with Shingles and started on an antiviral. Multiple providers on the telehealth visit think that Shingles is a reaction to the Covid vaccine, as he is otherwise healthy and young and had recently gotten the vaccine. His symptoms are improving and he will be on antivirals for a week total. He denies other symptoms or concerns at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/27/2020,6.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Erythema', 'Herpes zoster', 'Rash', 'Skin swelling']",1,PFIZER\BIONTECH,IM 921949,ND,49.0,F,I had left chest wall pain (lateral) while breathing and laughing. I don't believe it was muscular.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/15/2020,12/21/2020,6.0,PVT,No,No,No,,No,"['Blood test', 'Chest X-ray', 'Chest pain', 'Musculoskeletal chest pain']",UNK,PFIZER\BIONTECH, 921950,CA,57.0,M,Bell?s palsy,Not Reported,,Not Reported,Not Reported,,Yes,N,12/23/2020,01/03/2021,11.0,PVT,Allopurinol; amlodipine; hydrochlorothiazide; lisinopril; atorvastatin,HTN. Hypertriglycerademia; gout,,Shingles 2.5 years ago tiredness,None,['Facial paralysis'],1,MODERNA,IM 921951,TX,47.0,F,"I'm a employee at Airport on the Day of the vaccine, i had a severe headache and had to take Tylenol and Butal-acet-caff 50-325-40 mg� and slept the whole day. The next day I woke up better but a lingering headache persists to this date. Also, along with the headache I have nausea and light headedness the whole day. As well as dizzy spells where everything spins even if I am sitting down. Dr. prescribed methylprednisolone 4 mg dose pack. Can I take this medication or what can I take because it's not getting any better",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,"HYDROXYCHLOROQUINE 200 mg, PRAMIPEXOLE 1 mg Butal-acet-caff 50-325-40 mg, Prevention: Divalproex, Baclofen 10 mg, Duloxetine HCL DR 30 mg, zyrtec, Tylenol",No,"Lupus, tension headaches, SJOGREN'S SYNDROME, Periodic� limb movement disorder,",,No,"['Dizziness', 'Headache', 'Nausea', 'Somnolence', 'Vertigo']",UNK,MODERNA,SYR 921952,CA,57.0,F,"Four hours after vaccination, headache on left side. Next morning, pain was so intense, couldn't stand up. Still has light lingering headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,WRK,no,no,no,,"pollen, shellfish","['Dysstasia', 'Headache']",1,MODERNA,IM 921953,AK,66.0,F,Left upper arm hardness and redness. pt has a birth mark above the area. It was treated with hot packs/ benadryl/ hydrocortisone cream and ibuprofen. Pt received one dose of cephalexin but was told to hold on taking any more .,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/04/2021,1.0,PVT,levothyroxine/ bengay,none,hypothyroidism.,,none,"['Birth mark', 'Injection site erythema', 'Injection site induration']",1,MODERNA,IM 921955,AR,28.0,F,sore arm with rash/redness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,SEN,UNKNOWN,UNKNOWN,UNKNOWN,,UNKNOWN,"['Injection site erythema', 'Injection site rash', 'Limb discomfort']",UNK,MODERNA,IM 921956,IL,32.0,F,"Subject was administered the COVID vaccine on Thursday, December 31st. Over the weekend she noticed the injection spot was turning red. On Monday, January 4th, 2021, the injection area had now become quite large and looked like she had hives. The area is red and raised. She consulted her PCP and was administered Cetirizine and told to use cold compresses to reduce the spread and the redness. She said the red area was a feeling of tightness, but no pain. She did not miss any work. She is in no pain. She will continue to monitor the area for any changes.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/03/2021,5.0,PVT,,None,,,No known allergies,"['Injection site erythema', 'Injection site urticaria', 'Skin tightness']",1,MODERNA,IM 921957,MI,36.0,F,"Within 15 min of receiving the vaccination she began to be itchy and her arm swole right leg began to itch and her ears began to burn, hives around the lips. She said her chest felt tight. She received 25 mg of Benadryl. After 20 minutes she received another dose of Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,None known,None,None,,History of allergic reaction none to vaccines,"['Burning sensation', 'Chest discomfort', 'Peripheral swelling', 'Pruritus', 'Urticaria']",1,MODERNA,IM 921958,CA,46.0,F,"I experienced Fatigue, chest tightness, and increased blood pressure the first 2 days. Day 5 I started having pain in my upper back, left side. The next day had increased discomfort and developed a rash. Today, it is extremely painful and spread from the upper back to across my left breast. My PCP agrees that it is Shingles. I am beginning a course of Valtex today, to lesson the severity of symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/01/2021,4.0,PVT,"Losartan, Amlodipine, trazodone, albuterol, Atrovent, Dulera, Singular, Mirena IUD, Vitamin D3, Multivitamin, Vitamin C, Calcium, turmeric, Irish sea moss, black seed oil","Asthma Flare, treadted with Zithromax and prednisone taper.","Asthma, high blood pressure","Flu vaccine 10 years ago, developed swollen left arm. The syringe used had a latex base.","Keflex, latex, fresh dill","['Back pain', 'Blood pressure increased', 'Chest discomfort', 'Fatigue', 'Herpes zoster', 'Rash']",1,PFIZER\BIONTECH,IM 921959,VT,32.0,F,"Initially redness amd swelling. resolved on 12/29/20, redness, swelling and pain reocurred on 1/3/21, Better on 1/5/21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/28/2020,1.0,PVT,unknown,no,none known,,none,"['Erythema', 'Pain', 'Swelling']",1,MODERNA,IM 921960,TX,31.0,F,"At 1623 patient reports itchiness all over face, tingling to jaw line & right eye twitching. BP 109/76, P 77, R 20, SpO2 100%. At 1628 pt. examined by NP, reporting no redness/swelling to throat and lungs clear upon auscultation. Pt. given oral solution of Benadryl 25 mg along with water to drink. Reports increase to itchiness to face. At 1640 Reports itchiness only along jaw line with the other symptoms resolved. BP 111/76, P 80, R 20, SpO2 98%. At 1643 patient states able to drive home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,unknown,unknown,unknown,,none,"['Blepharospasm', 'Paraesthesia', 'Pruritus']",1,MODERNA,IM 921962,TX,67.0,F,"burning sensation in my flank area of left back, extending from the spine. I couldn't wear clothing because it was unbearable, It lasted until Monday. I texted my friend that is a Dr and he recommended to wait it out. I still get brief sensations but I am more or less over it",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/21/2020,1.0,PVT,"cimbastatin, losartin, multivitamin, probiotic, allergy medication",no,"Sinusitis triggering bronchitis, high BP",,benadryl,['Burning sensation'],1,PFIZER\BIONTECH,SYR 921963,CA,34.0,M,"Fever 100.1, Chills and body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 921964,AR,20.0,M,sore arm with rash/redness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,SEN,unknown,unknown,unknown,,unknown,"['Injection site erythema', 'Injection site rash', 'Pain in extremity']",UNK,MODERNA,IM 921965,AK,39.0,F,"itching in mouth, flushed face, itching chin/cheeks",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"famotadine, cetirizine",na,"allergic rhinitis, gerd, osa, preDM",,"codeine, monistat, augmentin","['Flushing', 'Oral pruritus', 'Pruritus']",1,MODERNA,SYR 921966,AR,21.0,F,sore arm with rash/redness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,SEN,unknown,unknown,unknown,,unknown,"['Injection site erythema', 'Injection site rash', 'Pain in extremity']",UNK,MODERNA,IM 921967,CA,58.0,F,"Really fatigue for 24 hours, Like she was hit by a car. It went away after 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,no,no,no,,no,"['Fatigue', 'Malaise']",1,MODERNA,SYR 921969,MO,43.0,F,"""I began to have flu like symptoms around 1000 am after receiving the vaccine around 730 am Monday 12/28. By the time I arrived home around 3 pm I had chills, achiness but never ran a fever. This went on throughout that evening. When I woke up the next day I felt great until approximately 1000 am and then began having diarrhea. That lasted for about 5 hours. I had some soreness in my L arm where the shot was given however the following Monday (1-4-21) I had a hard lump where the shot was given and a red rash that appeared. The rash has improved today but is not completely gone.""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['Chills', 'Diarrhoea', 'Influenza like illness', 'Injection site induration', 'Injection site mass', 'Injection site pain', 'Injection site reaction', 'Pain', 'Rash erythematous']",1,MODERNA,IM 921970,FL,58.0,M,"Patient has a history of heart disease. Post vaccine patient experienced abnormally high blood pressure, even for that of a patient with preexisting disease. Blood pressure was monitored and recorded at least three times a day. Around 48 hours post vaccine, patient experienced sweats and shortness of breath while at work. Heart rate per monitoring device recorded around 145+ even reaching a max heart rate of 160. 72 hours post dose on New Years Eve around 23:00 patient experienced high blood pressure and sinus arrhythmia resulting in admission to the emergency department. Labs and an ECG were ordered.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/30/2020,2.0,PVT,"Atorovastatin, ventolin, tamsulosin, indapamide, amlodopine",Heart Disease,Heart Disease,,Na,"['Differential white blood cell count', 'Dyspnoea', 'Electrocardiogram', 'Full blood count', 'Heart rate increased', 'Hyperhidrosis', 'Hypertension', 'Sinus arrhythmia']",1,MODERNA,IM 921971,FL,38.0,F,"About 4 or 5 hours after vaccine, I was covered in a red rash from head to toe. I went to the ER and got a shot of steroids and I was put on oral steroids for 5 days. Two days after, I had a full blown chest cold and flu like symptoms. I started antibiotics with breathing treatments. I'm better now. I've been sick for a good 10 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,Multi-vitamins Protonix Singulair Cardizem Propanolol Losartan,,Hypertension Acid Reflux Seasonal allergies,,Sudafed,"['Influenza like illness', 'Lower respiratory tract infection', 'Malaise', 'Rash', 'Rash erythematous']",1,MODERNA,IM 921973,AZ,41.0,F,"15 minutes after vaccine, had flushing, hypertension and tachycardia. 50 mg benadryl liquid. Patient anxious with these symptoms, feet shaking, felt heart ""beating out of chest."" Vitals gradually improved after benadryl over one hour. Sent home in care of husband. Will call tomorrow to check on patient and work with allergist on follow up vaccine before receiving.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,melatonin,"May, 2020 heart palpatations. Tele monitor with no finds",None,,none,"['Anxiety', 'Flushing', 'Hypertension', 'Palpitations', 'Tachycardia', 'Tremor']",1,PFIZER\BIONTECH,IM 921974,WA,45.0,F,"24 minutes post shot developed itchy scratchy throat, clearing throat, dry cough, sweating, sense of impending anaphylaxis ( same feeling I get with shellfish reaction) Bp stable, o2 says dropped 88%RA, tachycardia. Epi x 1 given 50 mg IM Benadryl and O2 placed seats normalized. Symptoms did not resolve, 6 minutes later second Epi shot given. Within 3 minutes symptoms starting to resolve. 125 Iv solumedrol, and given oral pred 40 mg daily x 3 days Felt fine next day(1/3) then 1/4/2020 recurrence of symptoms ( 2nd dose pred a little late 30 hours after last dose) Gave Epi shot, Benadryl 50 mg po ( pred on board) Symptoms did not resolve but no desaturation , bp stable, tachy, persistent throat clearing and dry cough 2nd Epi shot given Iv famotidine Iv solumedrol 125 mg, symptoms resolved, albuterol helpful lungs clear Pred 40 mg daily x 3 days add famotidine bid, add cetirizine bid 1/5/2021 felt fine in am, sensation of throat swelling itching and dry cough recurred , albuterol used helped temporarily ( had already taken morning cetirizine, famotidine and pred 40 mg) Saw allergist. Says fine, breathing fine slightly tachy, lungs clear, O2 says wnl, sweaty Albuterol given, helped Laryngoscopes with ENT negative for swelling, just mild vocal cord swelling from cough Started on pred taper 40 mg daily x 3, 20 mg qd x3, 10 mg dailyx3 Add Benadryl prn Add advair bid Continue cetirizine and famotidine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,Sertraline Fluoxetine Ibuprofen,None,None,,Shellfish Sulfa Iodine,"['Anaphylactic reaction', 'Cough', 'Hyperhidrosis', 'Laboratory test', 'Laryngoscopy', 'Oxygen saturation decreased', 'Pharyngeal swelling', 'Tachycardia', 'Throat clearing', 'Throat irritation', 'Vocal cord thickening']",1,MODERNA,IM 921975,FL,37.0,F,my right arm at injection site is still red and swollen a week and a day from injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,none,none,none,,none,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,SYR 921976,OH,31.0,F,"Around 11pm, a pain began in my left arm around the injection site that extended down to my elbow. The pain steadily increased throughout the night until I was no longer able to move my arm above the elbow joint. The pain stopped increasing by morning but has been holding steady for all of today (the day after the injection) and I am still mostly unable to move my arm. A fever of 100.0 - 100.5 developed around 10:00am on 1/5/21 and still remains.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,None,None,None,,None,"['Injection site pain', 'Mobility decreased', 'Pyrexia']",1,MODERNA,IM 921977,MI,42.0,F,"Nausea, arm numbness, weakness elevated blood pressure, (210/80) heart rate of 120bpm. All occurred 5 min post vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,None,None,None,,None,"['Asthenia', 'Blood pressure increased', 'Hypoaesthesia', 'Nausea']",1,MODERNA,IM 921978,NJ,29.0,F,"I felt that maybe they administered it too high, like the muscle area of my deltoid, and then around 10PM my shoulder started to hurt and then the next morning my pain level was 9/10 and it was unbearable. I was very fatigued and could not use my arm to work since the pain in the arm. I took some Ibuprofen and took a nap and then after that it got a little better, it still hurt but at least I could I use my arm. The next day it was fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,IUD and that is it,No,No,minimal injection site soreness,None,"['Arthralgia', 'Fatigue', 'Impaired work ability', 'Product administered at inappropriate site']",1,PFIZER\BIONTECH,SYR 921979,VT,29.0,F,"Redness and swelling next day, which resolved but 4 days later developed recurrent swellingwith nausea and vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/28/2020,1.0,PVT,unknown,no,none,,nka,"['Erythema', 'Nausea', 'Swelling', 'Vomiting']",1,MODERNA,IM 921980,IN,35.0,F,Rash bump at site of injection. Appeared 7 days after receiving the vaccine. Warm/hard to the touch. Itches. Increased in size from day 7-8,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,SEN,"NuvaRing, Escitalopram 20mg, Buspirone 10mg, Trazodone 50mg",none,none,,none,"['Injection site induration', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 921981,TX,47.0,F,"Pt. reported feeling aches in her back, skin sensitivity, tiredness and chills starting the evening of 01-02-21 going into 01-03-21. She took ibuprofen on Sat. and Sunday with some improvement in symptoms starting on Monday. Today 01-05-21 she noted an approximately 4 inch in diameter oval shaped rash slightly to anterior and below to her vaccine site in the Left arm. She is also having itchy eyes, reported as an allergy symptom",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,OTH,"Reports taking some vitamin supplements and Zyrtec, but none taken the date the vaccine was taken",None,None,,None known,"['Back pain', 'Chills', 'Eye pruritus', 'Fatigue', 'SARS-CoV-2 test negative', 'Sensitive skin', 'Vaccination site rash']",1,MODERNA,IM 921982,,38.0,F,scratchy throat,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,,['Throat irritation'],UNK,MODERNA,IM 921983,ID,60.0,F,Injection site pain and swelling the day after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Injection site pain', 'Injection site swelling']",1,PFIZER\BIONTECH,IM 921984,TN,45.0,F,"Severe dyspnea, wheezing, heart rate greater than 130",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,"Singular, fish oil, vitamin d, vitamin e, multivitamin, Crestor, allegra d(prn), albuterol (prn)",None,"Asthma, GERD",,None,"['Chest X-ray', 'Dyspnoea', 'Heart rate increased', 'Laboratory test', 'Wheezing']",1,PFIZER\BIONTECH,SYR 921985,UT,42.0,F,"One hour after receiving the vaccine I experienced a moderate headache that was relived by Ibuprofen. 24 hours after receiving the vaccine I experienced a rash (small raised red bumps) on both arms. lower back, and below knees on both legs. 36 hours after receiving the vaccine I experienced the same rash on my neck. 48 hours after receiving the vaccine I experienced the same rash on my upper chest.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PUB,Adderall,None,None,,"Avocados, Watermelon, Bananas","['Headache', 'Rash']",1,MODERNA,IM 921987,WA,61.0,F,"development of rash on arms, itchy feeling on arms and torso; feeling of increased warmth all over body--temp 96.8 temporal but felt very, very warm took Benadryl rash faded, decreased itchiness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,None,none,obesity,,allergic to penicillin and Cipro,"['Feeling hot', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 921988,CA,54.0,F,"Since 4pm Tuesday 29th, extremely lethargic, sleeping heavily and wet productive cough with clear sputum. No fever, has had body aches, lethargy, malaise, fatigue, bloodshot eyes and diarrhea, loss of appetite.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,WRK,None,None,None,,None,"['Decreased appetite', 'Diarrhoea', 'Fatigue', 'Lethargy', 'Malaise', 'Ocular hyperaemia', 'Pain', 'Productive cough']",1,PFIZER\BIONTECH,IM 921989,FL,46.0,F,"Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of airway and dizziness)",Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,None,High cholesterol Frequent UTIs,,,None,"['Anaphylactic reaction', 'Dizziness', 'Dyspnoea', 'Erythema', 'Obstructive airways disorder', 'Swelling', 'Swelling face']",1,PFIZER\BIONTECH,IM 921990,CA,31.0,M,"After leaving clinic - 20 minutes of observation, patient was driving home when you experienced slurred speech, flushed face, tingle, dizziness and felt like he would pass out. Lasted for approximately 30 minutes on side of the road. Patient rested in his vehicle until he felt better. Symptoms then resolved and he was able to drive home. All symptoms are fully resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,None,None,Denied,,"Mednoclyclene, Seaclor","['Dizziness', 'Dysarthria', 'Flushing', 'Paraesthesia']",UNK,MODERNA,IM 921991,ID,54.0,M,"Injection site pain, joint pain, fatigue all started morning after vaccination. Fatigue was decreasing by 1200.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,,,,,,"['Arthralgia', 'Fatigue', 'Injection site pain']",1,MODERNA,IM 921993,MD,60.0,F,"Red, itchy rash to upper back, both upper and lower extremities.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,"Norvasc 5 mg Atoravastatin 10 mg Hztz 25 mg Vitamin B 50,000 mg Calcium with vitamin D 500 mg",,Hypertension Hyperlipidemia PVD HPV,,Penicillin Naproxen Claritin,"['Rash', 'Rash erythematous', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 921994,IN,35.0,F,"Left arm swelling and tingling within 2 hours of injection, swollen lymph nodes in neck the following morning, within 72 hours severe abdominal pain, nausea, vomiting, and diarrhea that lasted 5 days, fatigue, and low grade fever (no higher than 100.8)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,"Do-Terra Vitamins, Vyvanse, Buspirone, Ibuprofen",None,ADHD and recreational asthma,,Seasonal allergies and some Caesar dressings,"['Abdominal pain', 'Diarrhoea', 'Fatigue', 'Lymphadenopathy', 'Nausea', 'Paraesthesia', 'Peripheral swelling', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 921995,NC,25.0,F,"Pain on left side of body- from site of injection to fingertips, shoulder, left side of torso (began 12/31 late pm) Chills (began 1/1 in morning) Fever (began 1/1 in morning) Headache (began 12/31 late pm) Nausea (began 1/1 late am) Dizziness ( began 1/1 late am) Night sweats ( began 1/1 late am) Muscle pain( began 12/31 late pm) Lack of appetite( began 1/1 early am) Heartburn( began 12/31 late pm) Tingling/ burning sensation when clothes touched skin (began 1/1 in afternoon) Took tylenol every 4- 5 hours (500 mg); took dramamine (25 mg ) on 1/1, and on 1/2 24 hour increment; Pushed fluids: water, Gatorade, Temperature check every 6 hours. Muscle pain, pain at injection sight, headache subsided 1/4 Chills, heartburn, lack of appetite, nausea, and dizziness subsided 1/3 Tingling/burning, fever, night sweats subsided 1/2",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,"Synthroid, triprevifem, vitamin D3",No illnesses at time or prior.,Hypothyroidism,,No known allergies.,"['Burning sensation', 'Chills', 'Decreased appetite', 'Dizziness', 'Dyspepsia', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Night sweats', 'Pain', 'Paraesthesia', 'Pyrexia']",1,MODERNA,SYR 921996,TX,38.0,F,"- This is client's 1st dose, client is a receptionist at the Health Department - Day of vaccination (12/28/2020): swelling at injection site, bruising & headaches - Day 1 (12/29/2020) through Day 7 (01/04/2021): swelling, bruising & headaches - Day 8 (01/05/2021) : abscess-looking bump to left deltoid area (the size of a small tangerine), itching to site, redness (mild-rash-looking), warm to touch, tender, pain to site, and states ""feels as if something stung"" - Client was sent home from work today (01/05/2021) mid morning and went to see Dr. from Primary Care - Clinic - Client states MD told her that reaction was from vaccine, to monitor reaction, to take over-the-counter Benadryl orally, to apply cold compresses, and was given release letter to return back to work on Wednesday 01/06/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PUB,Flanax (acetaminophen),None,None,,None,"['Contusion', 'Headache', 'Injection site abscess', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",7+,MODERNA,IM 921997,WA,28.0,F,Today is 8 days after covid vaccination. Skin is raised and red about 4 inches around injection site in right arm. Injection site is sore to the touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/31/2020,3.0,PVT,"Diclofenac DR 75mg, acetaminophen 500mg, vitamin D 250mcg, women's multivitamin, Alli 60mg",,,,,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,SYR 921998,VT,58.0,F,"swelling and redness next day, resolved, but reocurred 8 days later",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/28/2020,1.0,PVT,unknown,none,none,,none,"['Erythema', 'Swelling']",1,MODERNA,IM 921999,AK,51.0,F,"Numbness and tingling in arm and especially in fingers and hand of the vaccinated arm. Numbness for over 4 hours and continues at this time, but lessening. Numbness also felt on tip of nose- lasted an hour on tip of nose and then dissipated. No treatments provided only watched for anything worsening.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PUB,None,None,None,,Sulfa- Rash,['Hypoaesthesia'],1,PFIZER\BIONTECH,IM 922000,WA,55.0,F,"Injection site pain Extremely tired, chills, fever, brief sinus pain, body/joint pain Symptoms resolved at 8:00PM the following day (approximately 29 hours after vaccine administered). Stayed home from work the day after the vaccine administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Impaired work ability', 'Injection site pain', 'Pyrexia', 'Sinus pain']",1,MODERNA,IM 922001,MD,38.0,F,Sore throat Decreased taste Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,01/04/2021,34.0,PVT,Levothyroxine Flovent,None,Hypothyroidism Asthma,,NKDA,"['Headache', 'Hypogeusia', 'Oropharyngeal pain', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,IM 922002,GA,51.0,M,"Abdominal cramps and bloating starting approx 24 hours after vaccine lasting 1-2 days, fatigue for 2 days, deltoid soreness with movement for 1 week, tender left axillary adenopathy noted Monday Jan 4th.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,"querecetin, turmeric",,,,,"['Abdominal distension', 'Abdominal pain', 'Fatigue', 'Lymphadenopathy', 'Myalgia', 'Pain']",1,MODERNA,IM 922003,MA,40.0,F,"Employee stated that she is allergic to multiple medications and was anxious that she may get a reaction to the vaccine. After sitting for about 1/2 hour after receiving the vaccine, she began to c/o of a sharp epigastric pain. Employee stated that she only had a banana to eat for breakfast. She was transferred over to the first responders area, where she was assessed.Her vitals were within normal range. After few minutes on the stretcher employee stated that the pain was slowly subsiding, she then opted to leave.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,WRK,,,,,,"['Abdominal pain upper', 'Multiple allergies']",1,MODERNA,IM 922004,KS,25.0,F,PM Tingling and numbness to both legs. She said this is the type of reaction she gets when she has an allergic reaction to a decongestant. 50mg of PO Benadryl. Vitals where unremarkable throughout. Dismissed her by wheel chair directly to her husband at 9PM on 1/4/2021 due to legs still being a little shaky.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,"Pro-Air inhaler,Benadryl, Simbicort,Birth Control",None,None,,"Seasonal Allergies, Decongestants, Cats, Pet Dander, Raw Veggi","['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,SYR 922005,ID,46.0,F,"Injection site pain, swollen Lymph node under arm on the side on vaccination. Started the day after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,,,,,,"['Injection site lymphadenopathy', 'Injection site pain', 'Lymphadenopathy']",1,MODERNA,IM 922006,WA,24.0,F,"15 min after injection, pt reports dizziness. She was closely monitored and then she threw up as well",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,unkown,unkown,none,,none,"['Dizziness', 'Vomiting']",1,PFIZER\BIONTECH,IM 922007,OR,39.0,F,"On 1-03-21, I noticed a large lump on the left side of my clavicle the size of a quarter and increased pain. I went to urgent care and the PA was unable to diagnose what caused the lump or what the lump was. On 12-31-20 and 1-04-21 had nose bleeds. Nose bleeds are not a normal occurrence for me and I emailed my NP for further treatment options. No response yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,WRK,"Topamax, Lexapro, Potassium, Vitamin D, Fish Oil, Flax Seed Oil, Vitamin C, Zyrtec, and Flonase.",None,Migraines and Anxiety Disorder.,,"SULFA, Honeydew melon","['Epistaxis', 'Mass', 'Pain', 'Ultrasound scan']",1,MODERNA,IM 922008,TX,84.0,F,"At 1054 patient c/o headache at a 8/10 on the Wong pain scale, dizziness. BP 159/66, P 57, R 20, SpO2 96%. At 1110 headache 2/10 on pain scale, dizziness gone. BP 150/60, P 52, R 20, SpO2 96%. At 1120 PCP here to assess patient, instructions to return next week to clinic for an office visit. Pt. reports headache gone. At 1122 BP 154/59, P 54 with symptoms still gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,"Cyclobenzaprine; Detrol La; Fosamax; Gabapentin; Hydralazine; Lactulose; Lipitor; Losartan, Triamterene - Hydrochlorothiazide; Meloxicam; and Vitamin D3",unknown,chronic bilateral low back pain; right knee pain; dyslipidemia; hypertension; osteoporosis,,none,"['Dizziness', 'Headache']",1,MODERNA,IM 922009,NY,47.0,F,"Five minutes after injection, tingling tongue, severe dizziness, foggy brain, chest pressure, then coughing non stop",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,None,None,None,,MRI contrast,"['Chest discomfort', 'Cough', 'Dizziness', 'Feeling abnormal', 'Paraesthesia oral']",UNK,MODERNA,IM 922010,DE,56.0,F,"Red raised flat and raised bumps/rash on thighs front and back, knees, shins, ankles, and feet. Very small amount on back maybe 3-4 bumps",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PVT,"Remicade, Arava, Lasarten/HTCZ, Zyrtec, norvasc, multivitamin, vitamin E , singular(generic), B12, Echinacea, Collagen, Tumeric, Meloxicam,",Cold like symptoms and ulcers in roof of mouth and Tongue,Rheumatoid Arthritis and HTN,,NKDA,"['Activated partial thromboplastin time', 'Antinuclear antibody', 'Full blood count', 'Prothrombin time', 'Rash', 'Rash erythematous', 'Rash papular', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,SYR 922011,CA,36.0,F,"rhinorrhea, headache, tested for COVID-19 on 1/04/2021 and was Positive",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,01/02/2021,11.0,PVT,,,,,,"['Headache', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 922012,CA,32.0,M,Redness swelling and tender to touch to left eye,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,SEN,Redness/swelling and tender to touch on left eyebrow,,,,,"['Eye pain', 'Eye swelling', 'Ocular hyperaemia']",1,PFIZER\BIONTECH,IM 922013,CA,45.0,F,Patient began feeling symptoms of tongue and hand tingling and throat tightening 5 minutes after receiving her dose. Her vitals were taken and were stable. After 5 more minutes her hands stopped tingling and within 15 minutes her throat symptoms resolved. She continued to have tongue tingling without any facial or tongue swelling. After 25 minutes a physician was contacted and cetirizine 10mg was administered. 25 minutes later her symptoms were resolved and her vitals are stable. She was allowed to go home after that time and was advised to follow up to her PCP.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Atenolol, paraguard",none,hypertension,,"amlodipine, coconut","['Paraesthesia', 'Paraesthesia oral', 'Throat tightness']",1,MODERNA,IM 922014,CA,52.0,F,Lower right leg skin rash. Localized size of Quarter,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/26/2020,4.0,PVT,,,,,,['Rash'],1,PFIZER\BIONTECH,IM 922015,WY,18.0,M,"Pt describes falling with onset of weakness below the hip level about 6 inches above the patella with missing clonus reflex. The pt cannot squat down with associated observable loss of strength, pt is not able to stand up. The pt has fallen 7 times since symptom onset around lunchtime between 1200 and 1300. Pt denies LOC.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/31/2020,01/05/2021,5.0,PVT,no,no,no,,no,"['Areflexia', 'Aspartate aminotransferase increased', 'Asthenia', 'Blood chloride normal', 'Blood creatinine normal', 'Blood glucose normal', 'Blood potassium decreased', 'Blood sodium normal', 'Blood urea decreased', 'Carbon dioxide normal', 'Differential white blood cell count abnormal', 'Drug screen', 'Dysstasia', 'Fall', 'Full blood count abnormal', 'Haematocrit normal', 'Haemoglobin normal', 'Leukocytosis', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Mobility decreased', 'Muscular weakness', 'Platelet count normal', 'Red blood cell sedimentation rate normal', 'Rheumatoid factor', 'Shift to the left']",1,PFIZER\BIONTECH,IM 922016,WA,50.0,F,"That evening experienced significant fatigue. By next morning felt like ""she'd been hit by a semi-truck"" was too fatigued to get out of bed, had a low grade fever of 100.1, and significant body aches. Spent 2 days in bed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"gabapentin, pramipexole, trazadone, buspirone, bupropion, hydroxyzine amelate, plaquenil, Synthroid, metformin",autoimmune issues chronically- mixed connective tissue disorder and fibromyalgia,"mixed connective tissue disorder, fibromyalgia, migraines,",,"latex, penicillin, sulfa, corticosteroids (topical & systemic), tegretol, Neomycins","['Fatigue', 'Pain', 'Pyrexia']",1,MODERNA,IM 922018,VT,58.0,F,"redmess,swelling, and itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/27/2020,1.0,PVT,unknown,none,unknown,,none known,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA,IM 922020,NE,22.0,M,Large swelling and redness on left shoulder. Growing in size numerous days in a row.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,OTH,,,No,,None,"['Injection site erythema', 'Joint swelling']",1,MODERNA,IM 922021,,27.0,M,"1459: vaccine administered 1508: Patient reported feeling lightheaded and dizzy; VS 97.3, HR 58, BP 106/50, 97% room air- First responder called 1513: patient transported to be by first response team (seeing ""black"") VS temp 98, BP 68/36, HR 46, O2 97% 1516: patient reports feeling a ""little better"" VS temp 98, BP 104/55, HR 63, O2 98% Pt denied needing transport to ED for further treatment. Continued sitting in clinic, drinking juice and was monitored. At 1600, patient discharged from clinic back to his work department- reported ""feeling fine""",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,WRK,,,,,,['Dizziness'],1,MODERNA,IM 922022,,40.0,F,"Received vaccine 12/29/2020 and site became raised, red and hot. On 12/30/20 area is larger, raised, red, hot and painful. When to ED on 12/31/2020 and had increased redness to the injection site. The site is painful nonpruritic. Low grade fever (99.5), otherwise normal vs. patient with localized reaction from Covid vaccine, patient believes that she may not have received the vaccine in her muscle. She has pictures of the actual vaccination that show as the vaccine was placed into her arm that the needle was somewhat out of her arm and not fully engaged into her arm. Patient will start a short steroid burst of 40 mg of prednisone daily, patient is an RN, is concerned she may have cellulitis potentially due to vaccine not being administered properly, will cover with keflex. Tryptase pending.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,UNK,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Local reaction', 'Pyrexia', 'Tryptase']",1,MODERNA,IM 922023,NY,24.0,M,"Solid red oval going 3cm laterally each way from injection site, and 5cm above and below injection site. Heat and minor swelling around injection site. Pain in armpit, almost unnoticeable while resting. upon raising armpit pain worsens. Swelling in the armpit as well. Headache. (NO fever).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/04/2021,9.0,PVT,"Famotadine, Dexilent, Ibuprofen, bayer one a day mens multivitamin",,"Ehlers-Danlos syndrome, raynaud's",,Cat hair makes my eyes itch,"['Axillary pain', 'Headache', 'Injection site swelling', 'Injection site urticaria', 'Injection site warmth', 'Pain']",UNK,MODERNA,IM 922024,NY,37.0,F,approximately 2 hours post injection the patient developed an itchy red rash on her face and chest. No swelling of lips or tongue. No SOB. Treated with antihistamines with improvement. This is a very common reaction to medication for this patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"duloxetine, mirena, Vitamin D",none,obesity,,"cephalosporins, Penicillins, buproprion, bee stings, sulfa","['Rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 922025,MN,43.0,M,"Headache, Muscle pain, sore throat, chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,high blood pressure medication.,None,High blood pressure,,sulfa drugs,"['Chills', 'Headache', 'Myalgia', 'Oropharyngeal pain']",1,PFIZER\BIONTECH,SYR 922026,WA,45.0,F,"Notice yesterday, a large round red circle about 2 inches across, raised and swollen, hot to the touch, soreness and tender.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,01/04/2021,14.0,PVT,"Eliquis, Metoprolol, Fluoxetine",no,High blood pressure,,Penicillin,"['Erythema', 'Pain', 'Skin warm', 'Swelling', 'Tenderness']",1,PFIZER\BIONTECH,IM 922027,FL,33.0,F,"Tongue swelling, throat itching, slight shortness of breath, headache, joint pain, fatigue, sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/05/2021,4.0,PVT,"Daily multivitamin, probiotics",None,"Celiac disease, arthritis, IBS, and GERD",,"Celiac disease, dairy, casein and soy intolerance, some swelling with a past tricyclic antidepressant","['Arthralgia', 'Dyspnoea', 'Fatigue', 'Headache', 'Oropharyngeal pain', 'Swollen tongue', 'Throat irritation']",UNK,MODERNA,SYR 922028,NY,54.0,F,"Severe right arm pain, nausea, fever, fatigue, muscle pain, general feeling of being ill. Started 11pm on 1/4/21 continuing through 1/5/21 evening.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Stelara injections every 6 weeks potassium, lasix, omeprazole, zertec, senna, simvastatin",none,Crohns disease,,"Latex, Avacatos, Kiwi, sulfa antibiotics","['Fatigue', 'Malaise', 'Myalgia', 'Nausea', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA,IM 922029,KS,36.0,F,"At 8:20 AM she complained of tongue swelling, Facial Flushing, BP went up 174/112, Pulse 123, Used albuterol inhaler, Benadryl 50 MG PO, Vitals Signs gradually returned to normal BP on discharge 122/87, Discharged to coworkers at 9AM.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Multivitamin with Iron,Fish oil 2000 mg daily, Calcium 800Mg daily, Vitamin D 1000 IU Daily.",None,Unknown,,IV Contrast Dye,"['Blood pressure abnormal', 'Flushing', 'Swollen tongue', 'Tachycardia']",1,PFIZER\BIONTECH,SYR 922030,MI,46.0,F,"Thyroiditis with hyperthyroidism: 5 days after vaccine developed sweats, 10 days after the vaccine (1/1/21)developed fevers and right sided neck pain, tachycardia, myalgia",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/27/2020,5.0,PVT,Iron supplement,None,Thalassemia,,None,"['Blood thyroid stimulating hormone decreased', 'Hyperhidrosis', 'Hyperthyroidism', 'Myalgia', 'Neck pain', 'Pyrexia', 'Red blood cell sedimentation rate increased', 'Tachycardia', 'Thyroiditis', 'Thyroxine free abnormal', 'Tri-iodothyronine free abnormal', 'Ultrasound scan abnormal']",1,PFIZER\BIONTECH,IM 922031,CA,37.0,F,"headache, fever 101.9, head congestion, loss of taste & smell, tested for COVID-19 on 1/04/2021 and it was negative",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,01/01/2021,10.0,PVT,,,,,,"['Ageusia', 'Anosmia', 'Headache', 'Nasal congestion', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 922032,WI,49.0,F,Received Pfizer covid 19 vaccine 1/2/21(Saturday). Bed time Saturday injection site was and still is tender. Also notice mild body aches at this time. Sunday came home from work w fever chills headache and vomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,WRK,Losartan,None,Hypertension,,None,"['Chills', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,SYR 922033,AZ,48.0,F,"I got it and within that short period of time I really just didn't feel well. My heart was racing and not racing, blood pressure was up and down.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,UNK,,No,I have high blood pressure,,I am allergic to sulphur.,"['Blood pressure fluctuation', 'Electrocardiogram', 'Malaise', 'Palpitations']",1,MODERNA,IM 922034,,40.0,F,"8 days post vaccine, red sharply demarcated rash over vaccine site, with pruritis. Resolved in about 1 day with topical steroid cream.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/31/2020,8.0,PVT,,,,,,"['Injection site erythema', 'Vaccination site pruritus', 'Vaccination site rash']",1,MODERNA,IM 922035,OK,25.0,F,"Patient complained of shortness of breath/tightness in chest. 3 RNs present to assess and evaluate with epilepsy-pen on hand to administer as necessary. Patient has not had any reactions to any previous vaccinations. Upon assessment, the patient was alert & oriented and was responding to questions. Patient was not tachycardia nor did she have any tachypnea with heart rate @ 86, RR @ 18, SPO2 @ 99%. Breath sounds were reported to be CTA bilaterally (conducted by RN & director of clinical operations). Patient's legs were evaluated, cold compress applied to back of neck, & she was instructed to take slow, deep breaths (in through nose, out through mouth to prevent hyperventilation). Patient remained conscious, alert, and responsive entire time. EMSA/emergency response arrived at 1200 to evaluate. Care relinquished at that time.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,unknown,,None reported.,,"NKDA Reports allergy to various shellfish (historic); according to patient, has used albuterol inhaler and Benadryl in the past to treat such.","['Chest discomfort', 'Dyspnoea']",1,MODERNA,IM 922036,CA,38.0,F,"1/2/2021: In the evening, I started experiencing swelling (felt like a hard knot under the skin), itching, redness, and heat at the injection site. Earlier in the day I noticed a little pain discomfort in my right arm pit. As the day wore on, I noticed swelling in my lymph nodes and the level of discomfort increased to the point that it disturbed my sleep. 1/3/2021: The pain and swelling at the injection site and armpit continued to be the same. I took ibuprofen to try and alleviate the level of discomfort. That evening before bed also took Benadryl to see if it would help with the injection site reaction. I also started experiencing a dull shooting pain and tingling from my armpit down to my wrist on my right arm. 1/4/2021: The injection site improved, no more knot, heat, or itching. It still remained a little swollen. Lymph nodes were still swollen throughout the day, but manageable with ibuprofen. Shooting pain and tingling still occurring sporadically throughout the day. 1/5/2021: Still a little discomfort in the armpit, but seems to be improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,01/02/2021,7.0,PVT,Pirmella 1/35,n one,PCOS,,NTK,"['Axillary pain', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Paraesthesia', 'Sleep disorder']",1,MODERNA,IM 922037,CA,37.0,F,Patient received vaccine and started to feel lightheaded and flushed about 5 minutes after the dose. She fainted and was assisted to the ground. She did not lose consciousness. She was asked about her recent insulin dose and it was suspected that she did not eat enough food after taking her morning insulin.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Levothyroxine, insulin, regular, lantus, imitrex",unknown,"type 1 diabetes, hypothyroidism",,unknown,"['Blood glucose', 'Dizziness', 'Electrocardiogram', 'Flushing', 'Syncope']",1,MODERNA,IM 922038,WI,40.0,F,"States she started feeling sore and warm at injection site at about 9:30p on day of shot. Has a rash around injection site that was 4 inches across, but is slowly shrinking. Rash is warm,hot to touch. Elbow in right arm is tingling, but patient reports having long terms myalgias for other reasons.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PHM,Ibuprofen 800mg for muscle pain ongoing before vaccination,Sinus infection for the last 4 months. Finished levaquin 500mg on 1/3/21,"hypothyroid, hysterectomy in July 2020, asthma, long standing muscle aches and pains.",,"Rocephen, Azithromycin","['Injection site pain', 'Injection site rash', 'Injection site warmth', 'Paraesthesia']",1,MODERNA,IM 922039,CA,51.0,M,"headache, body aches, cough, chest pain when deep breathing, was tested for COVID-19 on 1/04/2021 and it was Positive",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/31/2020,3.0,PVT,,,,,,"['COVID-19', 'Cough', 'Headache', 'Pain', 'Painful respiration', 'SARS-CoV-2 test positive']",1,MODERNA,IM 922040,MA,33.0,F,"Had mild to moderate pain in injection site (R upper arm) for approx 4 days after the vaccine, resolved entirely by 1/3. On 1/5, 7 days after receiving vaccine, developed onset within a matter of hours of R upper arm pain, swelling, itching and erythema.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/05/2021,7.0,PVT,Multivitamin; took ibuprofen and Tylenol following first dose for headache and injection site pain,None,None,,Bactrim and cefodroxil (history of rash after taking both antibiotics),"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 922041,TX,45.0,F,"At 1310 patient reported lightheadedness, dizzy and throbbing to right temple. BP 136/87, P 60, R 20, SpO2 100%. At 1328 BP 146/88, P 72, R 20, SpO2 100%. Reports feeling dizzy, & tired. At 1336 Per RN, will monitor another 15 min since pt. c/o feeling woozy when standing. At 1341 Tingling in upper right chest area. Escorted to BR via w/c to urinate. At 1350 patient reports symptoms have resolved. BP 148/89, P 74, R 20. Reports can drive self home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PUB,Vitamin D,low Vitamin D,asthma,,none,"['Dizziness', 'Fatigue', 'Headache', 'Paraesthesia']",1,MODERNA,IM 922042,AZ,46.0,F,"At 2pm, I felt very tired like I hadn't slept all night with warm rosy cheeks-low fever. I took an 800mg and went to bed, woke up the next morning feeling great with no reactions.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,Ibuprofen 800mg,none,none,,"red dye, bamboo shoot","['Erythema', 'Fatigue', 'Pyrexia']",1,PFIZER\BIONTECH, 922043,TX,55.0,F,"Started having rash the day following the vaccination, the rash extended to the neck and is more severe, still until today the seventh day after the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,UNK,,,,,,['Rash'],UNK,MODERNA,SYR 922045,WA,50.0,F,"On the way home I developed upper lip swelling followed by some right cheek swelling. At this point, I got really concerned ( maybe overly) but I pulled into a parking lot and called 911. I never had difficulty breathing and I had a normal pulse oximetry. The fire department stayed with me for a while and it did not worsen, so I declined the ambulance ride and headed home. The swelling lasted about 3 hours and resolved in reverse direction ( lip first, followed by the cheek)",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,MIL,,,,,,"['Lip swelling', 'Swelling face']",UNK,MODERNA, 922046,TX,47.0,M,"I received the first Moderna shot at approximately 4:30pm on 12/23/2020. Around 9:30pm that evening, I began to feel fatigued and had a slight headache. I went to bed around10:15-10:30pm. Shortly after going to bed, my headache worsened and I began having chills. I was a bit restless that night and just did not feel well. These symptoms lasted until about 8am the following morning, 12/24/2020. I was still fatigued and still had a headache, which had lessened in intensity. I no longer had chills. The fatigue wore off throughout the day, but I still had a slight headache. Later in the evening I again became fatigued and still had a slight headache. The following day, my headache subsided, and I was only tired once evening came around. My symptoms had completely dissipated by 12/26/2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,None,None,None,,NKA,"['Chills', 'Fatigue', 'Headache', 'Malaise', 'Restlessness']",1,MODERNA,IM 922047,PA,48.0,F,"Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly after leaving observation area (32 min in observation) 9:30 lip tingling/ numbness, headache, back soreness/tightness/ pressure continues 9:40 hearing muted, fullness/mild pressure in ears - first left then right a little later Headache waxes and wanes - at times feels like vice squeezing my head 11:50 heartburn sensation 12:00 localized swelling/ knot at injection site 12:04 wave of nausea/ mild heartburn Headache continues off and on 3:30 ear ache, nausea, stiff joints, arm/shoulder/back pain, neck pain 16:00 dizzy/ nausea 16:22 flushed feeling in cheeks and neck; itchy cheeks, neck, chest 16:50 still flushed, itchy all over, heart palpitations. Fitbit shows HR 78 Hives for several hours. Hives gone by morning but still intermittently itchy. Eyes itchy/ feels like a contact lens is stuck in a wrong spot (have not worn contacts in 12+ years) Very mild cough started in evening 12/19 Hives in afternoon; itching off and on all day HR 91 (21:30) 21:43 HR 97 dizziness, headache 22:00 hives on face and abdomen 23:09 eye hurts again and is so itchy I want to rip it out of the socket, headache persists 12/20 Mild-to moderate itchiness upon waking, Itchiness off and an Mild headache off and on 9:15 heaviness in chest - feel I like do just before I get bronchitis, very mild cough Itchiness throughout the day. Hives on face in evening/Skin has a sunburn-type feeing Hives on neck and chest at bedtime Eyes itching then hurting - feels almost like pink eye type sensation As I was dozing off to sleep, heart palpitations - HR 97 12/21 Itchy/ hives on face, neck, upper chest By 12/21 afternoon, itchiness and hives abated. No further symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,WRK,None,None,None. I get bronchitis once a year usually but haven?t had it in 18-24 months,"Tetanus- entire upper left arm inflammation/ redness/ swelling (1998). Hep B vaccine (1993) limb paralysis, nausea, severe head","Tetanus, thimerisol, Flagyl, bactrim, Augmentin, bee stings, mosquito bites, adverse reaction to Hep B vaccine series","['Arthralgia', 'Back pain', 'Chest discomfort', 'Cough', 'Discomfort', 'Dizziness', 'Dyspepsia', 'Ear discomfort', 'Ear pain', 'Eye pain', 'Eye pruritus', 'Flushing', 'Head discomfort', 'Headache', 'Hypoacusis', 'Hypoaesthesia oral', 'Injection site nodule', 'Injection site swelling', 'Joint stiffness', 'Muscle tightness', 'Musculoskeletal stiffness', 'Nausea', 'Neck pain', 'Pain in extremity', 'Palpitations', 'Paraesthesia oral', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 922049,SD,30.0,F,"Following vaccine, patient became clammy, chills and shaky. C/O arms tingling, chest pressure, and lightheaded. Temp was 100., other VS normal, SaO2 100%. No respiratory distress. After period of time, patient still was not feeling well and ""couldn't feel her arms"". Decision made to go to the ED. 911 called and transferred",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,Unknown,None known,,,None Known,"['Chest discomfort', 'Chills', 'Cold sweat', 'Dizziness', 'Malaise', 'Paraesthesia', 'Sensory loss', 'Tremor']",1,MODERNA,IM 922050,NH,32.0,F,"Started with scant itching to site 12/28, developed large 4in x 4in inflamed site to L arm injection site, red spot hot to touch, tender and scantly itchy. Redness resolved in 3 days but arm continues to itch.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/28/2020,5.0,WRK,Nexplanon,None,None,,NKA,"['Injection site erythema', 'Injection site inflammation', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 922051,NY,40.0,F,"Patient with very mild swelling lip and itchy feeling of tongue. Given 37.5 mg Benadryl, all symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,none,none,none,,baking soda industrial glue,"['Lip swelling', 'Tongue pruritus']",1,PFIZER\BIONTECH,IM 922052,VA,36.0,M,"I had a fever, chills body aches and headache. I also lost my sense of smell.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,MIL,NO,No,No,,No,"['Anosmia', 'COVID-19', 'Chills', 'Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 922053,OH,42.0,F,Swollen lips,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Venlafaxine 75 mg, once a day Desogestrel/Ethinyl Estradol .15 my, once a day",None,None,,No known allergies.,['Lip swelling'],1,MODERNA,SYR 922054,AK,33.0,F,"25 minutes after injection got light headed, BP was taken by RN 139/91, face then got red, hot and itchy. II was taken to the Emergency Department for further observation. I I also experience some nausea, my tongue was slightly itchy, I had a stomach ache and some redness/swelling round the injection site. At the ED I was given 25 md Benadryl PO and observed for another hour and a half before being discharged.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,L-Lycine Vitamin D Fexofenadine Loratadine Symbacort Natures Bounty Hair Skin and Nails Supplement,,"Endometriosis, IBS",,Paprika- Anaphylaxis Zofran- Causes extreme nausea and vomiting,"['Abdominal pain upper', 'Dizziness', 'Erythema', 'Feeling hot', 'Injection site erythema', 'Injection site swelling', 'Nausea', 'Pruritus', 'Tongue pruritus']",1,PFIZER\BIONTECH,SYR 922055,PA,65.0,M,Patient reported one side of the mouth twitching but it was fine a few hours later by end of shift.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,Patient didn't indicate,none reported,none reported,,none reported,['Muscle twitching'],1,PFIZER\BIONTECH,IM 922056,NY,22.0,F,"Moderna COVID-19 Vaccine EUA Chills, headache , fatigue on night of vaccine only 12/31/20 Tired, headache, muscle pain, lymph node in left armpit swollen/painful 1/1/21 Lymph node pain gone 1/2/21 *Shortness of breath/chest pain 12/31/20 - currently",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Levocetirizin, purelax, tri-lo mariza",Covid 19 - cleared Dec 21,Hypothyroidism,DTap first dose as child (hives),DTap vaccine; amoxicillin,"['Chest pain', 'Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Lymph node pain', 'Lymphadenopathy', 'Myalgia']",1,MODERNA,IM 922057,CA,38.0,F,"1/2/2021: discomfort in armpit in am; swelling (felt like hard knot under skin), itching, redness, and heat at injection site in pm; swelling in lymph nodes and increased discomfort during the night-to the point of disrupting sleep. 1/3/2021: symptoms continued throughout the day; took ibuprofen with little relief. before bed took Benadryl to see if it would help with injection site pain. also started feeling dull shooting pain and tingling from armpit to wrist sporadically throughout the day. 1/4/2021: injection site discomfort started to resolve, no longer a knot, just slight swelling. lymph node swelling and discomfort continued. still feeling dull shooting pain and tingling in right arm. 1/5/2021: armpit discomfort starting to feel a little better, still sporadically getting shooting pain and tingling, just not as much.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,01/02/2021,7.0,PVT,Pirmella 1/35,None,PCOS,,NTK,"['Axillary pain', 'Injection site discomfort', 'Injection site erythema', 'Injection site induration', 'Injection site nodule', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Lymphadenopathy', 'Pain', 'Paraesthesia', 'Sleep disorder']",1,MODERNA,IM 922058,TX,49.0,F,Vertigo - BPPV,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,PVT,Birth control pill low dose,None,None,,None,['Vertigo positional'],1,MODERNA,SYR 922059,WI,40.0,F,"warm to touch at site of injection, rash up to 4 inches, starting to decrease",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PHM,na,sinus infection for 4 months,hypothyroidism and long term muscle aches,,rocephen and azithromycin,"['Injection site rash', 'Injection site warmth']",1,MODERNA,IM 922060,CA,50.0,F,"allergy symptoms, tested for COVID-19 1/02/2021 and was Positive",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,01/02/2021,9.0,PVT,,,,,,"['COVID-19', 'Hypersensitivity', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 922061,IN,62.0,F,"starting developing hives on back of my neck and head 6 days after the covid vaccine was administered. The hives progressed to my ears, arms, abdomen, groin, and upper thighs. I started taking Benadryl the first evening the hives started and continued benadryl for 2 more days. The benadryl did not stop the progression or help much with the intense itching. Had a telehealth visit via the telephone with Dr on Monday Jan 4. He ordered Atarax prn. I also started taking Pepcid and Zyrtec. Today I still have hives that are developing but at a much slower pace. The itching is much improved. DO I TAKE THE 2ND VACCINE?",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/01/2021,6.0,PVT,none,no,none,,no known allergies,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 922062,OH,51.0,F,"2 hours after vaccine I had a headache, high blood pressure, lightheaded and, dizzy the day after I was sore all day. In addition ligament pain with lots of muscle pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,,,Bleach and penicillin allergies,"['Dizziness', 'Headache', 'Hypertension', 'Ligament pain', 'Myalgia', 'Pain']",1,MODERNA, 922063,KY,71.0,F,"patient in waiting period post vaccine - received at 1738 p. Approx 6 pm, pt complained of not being able to take a deep breath. Was anxious prior to receiving vaccine. Skin warm, dry and pink. RR 18, BP 150/86, HR 72. States doesn't feel bad, but was restless and states I cant take deep breath. Refused ED, asked patient to wait for additional 20 minutes or so. Gave water/snacks. After 20 minutes, pt reported feeling better and wanted to leave.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Dyspnoea', 'Restlessness', 'Skin warm']",1,MODERNA,IM 922065,OH,52.0,F,"1/4/21 around 10am became extremely nauseated, clammy, dizzy and hot. No temp and had just received COVID POC test and was negative. Left to go home and had loose stool then chills, body aches, hot spells, and extremely tired. Could not stay awake and was in brain fog. Slept all day, all night and all day on 1/5/21. No appetite, stuffy nose, headache, chills and hot spells, no fever, Again unable to stay awake.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/04/2021,9.0,SEN,Allopurinol 300mg tab (Zyloprim) Bupropin 150mg (Wellbutrin) Bupropin 300mg (Wellbutrin) Fluxetine 40 mg furosemide 20 mg (lasix) Levothyroxine Sodium 100 mg tab (Snythroid) Lisinopril 2.5mg Lorazepam 1mg (Ativan) Steglujan 15-100 mg Tab S,none,Diabetes Depression Anxiety,,PCN,"['Chills', 'Cold sweat', 'Decreased appetite', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Feeling hot', 'Headache', 'Hypersomnia', 'Nasal congestion', 'Nausea', 'Pain', 'SARS-CoV-2 test negative', 'Somnolence']",UNK,PFIZER\BIONTECH,IM 922066,VA,38.0,F,"localized redness and swelling 0600 which spread noted at 1830, itching 1830",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,PVT,"Synthroid, zoloft, wellbutrin, zyrtec, Vitamin D3, Jolessa",,"Hypothyroidism, obesity, depression, anxiety",,Augmentin,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA,IM 922068,MA,27.0,F,Joint pain/Muscle aches - 2 - 36 hours following shot Arm pain at sight - 1-48 hours following shot Headache - 2-24 hours Rash on back similar to shingles - 4-12 hours Chills - 12-24 hours following shot,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,Cat Lactose intolerance,"['Arthralgia', 'Chills', 'Headache', 'Injection site pain', 'Myalgia', 'Rash vesicular']",1,MODERNA,SYR 922070,MT,62.0,F,"Moderna COVID-19 Vaccine EUA redness, warmth and itching of skin around injection site, no fever. Symptoms began last evening , one week after injection and are continuing. Notified employee health and PCP. will continue to self monitor and notify others if symptoms worsen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,PVT,"HCTZ, /vitamin D,senior multivitamin, aspirin 81mg,Fish oil, vitamin C , cholestoff, metamucil",none,"hypertension, hyperlipidemia",,"contrast dye, codeine","['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",UNK,MODERNA,IM 922071,CA,46.0,F,"feeling like motion sickness, light headed/unbalanced which is causing nausea, when in sitting position on couch i feel fine. too much movement gets me nausea and feeling light headed",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"pramipexole, Montelukust/cinguilar, Oxycontin",no,no,,no,"['Balance disorder', 'Dizziness', 'Motion sickness', 'Nausea']",1,PFIZER\BIONTECH,IM 922072,IL,47.0,F,"Pain at injection site, nausea, headache, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,PVT,"Lithium, Cymbalta, Iron, Vitamin D, Methyl Folate",None,Depression,,None,"['Fatigue', 'Headache', 'Injection site pain', 'Nausea']",UNK,MODERNA, 922073,NY,63.0,F,"I developed a red, swollen hard area surrounding the injection site 4 days after injection. It has now become warm to the touch and itchy. And this is 8 days post injection. I was given MODERNA COVID19 EUA",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/31/2020,3.0,WRK,None,None,None,,Amoxacillian and Biaxin,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 922074,AL,33.0,F,itching lower extremeties less than 30 minutes. no rash involved,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,,['Pruritus'],1,PFIZER\BIONTECH,IM 922075,TX,40.0,F,She describes joint pain and gradual numbness on her arms.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/24/2020,5.0,PVT,unknown,Denies,unknown,,no known drug allergies,"['Arthralgia', 'Hypoaesthesia']",2,PFIZER\BIONTECH,IM 922076,OH,40.0,F,"Moderate arm soreness 5-48 hours post-injection. Second, on the evening of 1/4/2021, noticed red rash, currently continuing to enlarge at time of this report. Intermittent light pruritis, mainly to palpation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,PVT,Prenatal vitamin Vitamin D,None,None,,None,"['Pain in extremity', 'Pruritus', 'Rash erythematous']",1,MODERNA,IM 922077,CO,33.0,F,"7 days after receiving Covid vaccine developed subclavicular lymphadenopathy on side of injection. Swelling developed and decreased. Due to area of lymphadenopathy, had to have breast exam, lab work and will need to schedule diagnostic mammogram and ultrasound. If that comes back clear there are discussions of CT scan.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/29/2020,7.0,PUB,"Levora, lisinopril 5mg, claritin",none,hypertension,,none,"['Full blood count', 'Lymphadenopathy', 'Metabolic function test', 'Swelling']",1,MODERNA,IM 922078,CA,37.0,F,"Dizzy/Fatigue/Achey/Nausea for 4-5 days. Sore arm at injection site for 3 days. Left toe swelled up and painful on day 2, but subsided within 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Multivitamin, probiotic, biotene, Allegra",None,Gestational diabetes/pre-diabetic,,Aspirin- cannot tolerate Diabetic Insulin- rash/blisters at injection site/down leg,"['Dizziness', 'Fatigue', 'Injection site pain', 'Nausea', 'Pain', 'Pain in extremity', 'Swelling']",1,MODERNA,SYR 922080,NY,62.0,F,Fever of 101 Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,UNK,metformin HCL Levothyroxine Amlodipine Farxiga Eliquis Dofetilide Rosuvastatin,Covid 19 11-27-2020,Atrial Fib DM HTn Hypothyroidism hyperlipidemia,,atorvastatin,"['Fatigue', 'Pyrexia']",1,MODERNA,IM 922081,PA,50.0,M,Patient reported tingling in her fingers but reported she was fine by 3:06pm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,SEN,Unknown,unknown,unknown,,unknown,['Paraesthesia'],3,PFIZER\BIONTECH,IM 922082,CA,21.0,F,Patient received Moderna covid 19 vaccine on 11:15am 1/5/2021. Patient had rested for 15 minutes after vaccination and reported felt fine. Patient went back to work. Patient fainted around 3:30pm. Patient regained the conscious quickly and the Paramedics said her blood sugar was normal and she had little orthostatic hypotension. The Paramedics gave her some fluid.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PHM,none,None,None,,None,"['Blood glucose normal', 'Orthostatic hypotension', 'Syncope']",1,MODERNA,IM 922083,AR,22.0,F,I?m running a 101 fever and I feel very weak. I?ve had fever since an hour after the shot and I?ve had it for 24 hours. I am continuing to feel weaker,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PHM,Lexapro 20 mg Adderall 20 mg Xyzal,None,Nonexistent,,None,"['Asthenia', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 922084,NY,52.0,F,"given 12/27/20; arm became reddened approximately 3in by 5in area, warm and tender to touch over deltoid are on 1/2/21; on 1/3/21 the reddened area traveled down arm about 3 in; redness gone on 1/4/21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,01/02/2021,6.0,PVT,paroxetine multivitamin vitamin D vitamin C glucosamine chondroitin Estroven fiber capsules tumeric fish oil zinc,none,none,,none,"['Erythema', 'Skin warm', 'Tenderness']",1,MODERNA,IM 922085,NM,53.0,F,"Immediately after receiving vaccine, she felt pain in her left deltoid, followed by a spasm in her left trapezius, and headache. She experienced a warm sensation travelling down her left arm. She described a feeling of muscle spasms in her left upper and lower extremity and was unable to bear weight on her left lower extremity due to the altered sensation. She endorsed acute nausea and vomiting. She was transferred from vaccine clinic to emergency department at 1420. Patient received diphenydramine 12.5mg IV @ 1722, prochlorperazine 10mg IV @1733, Lactated Ringers 250mL IV bolus @ 1733, ondansetron ODT 4mg @1445. Patient was diagnosed with an acute anxiety attack in the setting of a novel vaccine administration. She was discharged at 1854.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,"ropinirole 0.5mg tid, Basaglar 40 units qhs, omeprazole 20mg bid, atorvastatin 10mg qhs, tamsulosin 0.4mg qday, losartan 25mg qday, Trulicity 0.5mL qweek,",None,"HTN, T2DM, CKD Stage 4",,"metformin, codeine, latex","['Anxiety', 'Computerised tomogram normal', 'Electrocardiogram normal', 'Feeling hot', 'Headache', 'Immediate post-injection reaction', 'Injection site pain', 'Muscle spasms', 'Nausea', 'Vomiting', 'Weight bearing difficulty']",1,PFIZER\BIONTECH,IM 922086,WA,37.0,F,"The morning after my vaccine I woke up with a very sore upper arm. By 4pm that evening I had fatigue, chills, and body aches. I went to bed and slept much longer than normal and woke up the next morning without chills or body aches. My arm still hurt quite a bit and I started to have elbow joint and hip pain. The following day I started to have sciatica from my hip to my foot on my injection side, the left side. My elbow joint was sore for about 3-4 days after the injection. I also had some numbness right at the injection site the night of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PUB,Fluoxetine 20mg daily Vitamin D 5000 units daily Magnesium 200 MF daily Probiotic daily,,,,Ibuprofen Erythromycin base,"['Arthralgia', 'Chills', 'Fatigue', 'Hypersomnia', 'Injection site hypoaesthesia', 'Pain', 'Pain in extremity', 'Sciatica']",1,MODERNA,IM 922087,CO,40.0,F,Developed an itchy rash at injection site and tenderness 1 week after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,WRK,,,,,,"['Injection site pain', 'Injection site reaction', 'Rash pruritic']",1,MODERNA,IM 922088,OR,30.0,F,patient developed cellulitis at injection site 7 days following vaccination. associated lymphadenopathy. treated with keflex,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,"Vit D, Vit C, echinacea, zinc, microgestin FE, flexeril",none,none,,sulfa antibiotics,"['Injection site cellulitis', 'Injection site lymphadenopathy']",UNK,MODERNA, 922089,IL,55.0,F,Fever 100.6 next day. Chills headache fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,Synthroid Multivitamin VitD,No,None,,Ct contrast dye gadalomium for mri. Iodine cat Bad reactions to flu baccine,"['Chills', 'Fatigue', 'Headache', 'Pyrexia']",UNK,MODERNA,IM 922090,,37.0,F,"Patient became lightheaded, flushed, tachycardic, and developed hives. Patient was administered 25mg of diphenhydramine orally and observed. Patient quickly began feeling better, hives disappeared. The patient left with 2 other coworkers.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,UNK,,,,,,"['Dizziness', 'Flushing', 'Tachycardia', 'Urticaria']",1,PFIZER\BIONTECH,IM 922093,FL,33.0,M,"6 hours of 7/10 crampy umbilical abdominal pain starting 10:00am [22 hours after shot administration] with nausea. Improved thereafter. x5 bowel movements, from solid to liquid and diarrhea. Had to call out of work for afternoon, could not work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"Hydroxychloroquine, finasteride, Vit D, Vit C, Zinc",None,None,,NKDA,"['Abdominal pain', 'Diarrhoea', 'Impaired work ability', 'Nausea']",1,PFIZER\BIONTECH,IM 922094,ME,45.0,M,"Mild nausea at about 20 minutes post injection. Not unusual for me. Was on a 30 minute hold. Felt good. Left the station. Started to feel a little difficult to swallow. Tongue obviously swollen. No difficulty breathing. No hives. Called PCP. Notified Deputy Chief. Drove to clinic as precaution. Dr. advised of reaction. Dr. advised me to take Benadryl, 50mg, Every 6 hours for that day and the folllowing. Swelling improved within 1-2 hours of first Benadryl dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,"Dexilant, Hydralazine, Trianterene/HCTZ, Buspirone, Amlodipine, Pepcid Complete, ibuprofen, Tylenol",,"HTN, Acid Reflux, Anxiety",,Lisinopril,"['Dysphagia', 'Nausea', 'Swollen tongue']",1,MODERNA,IM 922095,WA,62.0,F,Sore arm beginning in the evening which got progressively worse for a couple of days then subsided completely. Some heart fluttering and some slight shortness of breath beginning a couple of days after. More a nuisance. No other symptoms I'm aware of although every little thing I feel now I think may or may not be a symptom like slight head throb but not consistent pain. Not sure because of vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,none,none,"obese, cholesterol, borderline blood pressure,",flu shot; usual flu like symptoms on occasion when received in the past.,"bleach (severe skin rash if touches skin), penicillin as a kid.","['Cardiac flutter', 'Dyspnoea', 'Headache', 'Pain in extremity']",UNK,MODERNA, 922096,NE,20.0,F,"Following you vaccination nausea, dizziness, and migraine. These persisted, and still happen occasionally. Started once a day and now is every few days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/16/2020,0.0,PVT,Nexplanon,,Anemic,,,"['Dizziness', 'Haemoglobin decreased', 'Migraine', 'Nausea']",1,PFIZER\BIONTECH,IM 922097,CA,26.0,F,Patient received vaccine and was monitored for the 15 minutes. Showed no s/s of a reactions and okay to leave. 1/5/21 received notice that patient reported fever of 103.0 and chills woke up in the morning and temperature was 100.0.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,unknown,unknown,unknown,,NKDA,"['Chills', 'Pyrexia']",1,MODERNA,IM 922098,PA,50.0,F,"The patient reported ankle, leg and hip pain for which she is taking Motrin",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,SEN,unknown,unknown,unknown,,unknown,"['Arthralgia', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 922099,WA,34.0,F,"Headaches, chills, sore throat and anxiety",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,,,Penicillin,"['Anxiety', 'Chills', 'Headache', 'Oropharyngeal pain']",1,PFIZER\BIONTECH,SYR 922100,TN,36.0,F,"Left axillary lymphadenopathy, swelling and joint pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,Zyrtec Singular,N/a,,,Celebrex Pcn Latex,"['Arthralgia', 'Lymphadenopathy', 'Swelling']",1,PFIZER\BIONTECH,IM 922101,CA,,M,"Patient received the covid vaccine on 12/21/2020. c/o new onset fever if 101.1m sore throat, HA, and body ache. Denies chills and cough Covid test on 12/28/2020 was negative. Restested on 1/5/2021 - result pending. Not sure if Influenza test was done.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/28/2020,7.0,UNK,,,,,,"['Headache', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'SARS-CoV-2 test', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH, 922102,NC,31.0,F,"Severe itching and burning all over body, moderate headache had to leave work early taking benadryl and tylonol.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,SEN,,,,Flu shot. Feel bad for 2-3 days about a week after vaccine,Oral birth control,"['Burning sensation', 'Headache', 'Impaired work ability', 'Pruritus']",1,MODERNA,SYR 922103,AZ,49.0,F,"Note recorded Jan 1 at 1400: two day history of headache, body aches, subjective fever, and diarrhea. Patient states that she received her COVID-19 vaccine 2 days ago. Patient reports that she will experience lower abdominal cramping just prior to BM, but states that this resolves immediately after having a BM. In regards to her headache, patient states that it came on gradually and is located around her frontal lobe. She states that it is dull but constant. She reportedly took ibuprofen at midnight, which seemed to offer some relief, but states that the headache came back this morning. She denies any neurological deficits such as weakness,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Took some ibuprofen several hours prior to visiting the ER,not known,not known,,NITROFURANTOIN,"['Abdominal pain', 'Diarrhoea', 'Dysuria', 'Headache', 'Myalgia', 'Pain', 'Pyrexia', 'Vulvovaginal candidiasis', 'Vulvovaginal pruritus']",1,MODERNA,IM 922105,,25.0,F,"About 20 minutes after I had a numb tongue and tingling. I was observed in the ED. Later that evening, around 9 PM I had upper lip tingling and numbness. The next day I woke up with upper lip swelling. I also forgot to mention that I had some chest tightness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,UNK,No,No,No,,I am allergic to penicillin,"['Chest discomfort', 'Electrocardiogram', 'Hypoaesthesia oral', 'Lip swelling', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 922106,NY,44.0,F,"Initially I was fine, but after 2 hours I started feeling joint pain. The next day the pain got worse and caused me to limp at work. I started feeling down. That night, I went home and had chills and fever. I was sweating in my sleep. I was fine on Christmas and now I have bronchitis like symptoms. I've seen 3 different providers at urgent care and was told that they don't know much about the vaccine. They told me to use Albuterol and go to the hospital if I get worse. I was told that I still have the antibodies from already having COVID twice and it may be causing me to have problems now. The first time was really bad and I developed pneumonia, but didn't go to the hospital due to all of the deaths occurring in city.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,Alepine Benazebrile (combination drug for hypertension) Allergy meds,,Asthma Hypertension Both conditions are controlled,,,"['Arthralgia', 'Bronchitis', 'Chills', 'Depressed mood', 'Gait disturbance', 'Night sweats', 'Pyrexia', 'X-ray']",1,PFIZER\BIONTECH,IM 922107,PA,71.0,F,Severe dizziness! Room spinning like merry go round. Lasted almost 30 hours. Only med taken was Tylenol. Was unable to walk. Had to lie flat with eyes closed .After lightheaded for at least 2days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,PVT,Amlodipine and voltaren,None,Arthritis and high blood pressure,,None,"['Dizziness', 'Gait inability', 'Vertigo']",1,MODERNA,IM 922108,TX,33.0,F,"Strong, pounding headache; 102 fever with chills and aches; arm pain from 1pm until 4am the next day. No treatment",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,None,None,None,"Aches, low fever and arm pain after flu shot 1 time",None,"['Chills', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 922109,OR,35.0,F,"Joint pain, muscle aches, fever, nausea/vomiting, abdominal pain, severe headache, rapid heart rate, perfuse sweating, facial swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Potassium citrate, Chlorthalidone, vitamin D3, iron,",,Chronic medullary sponge kidney disease,,Cipro,"['Abdominal pain', 'Arthralgia', 'Headache', 'Heart rate increased', 'Hyperhidrosis', 'Myalgia', 'Nausea', 'Pyrexia', 'Swelling face', 'Vomiting']",1,MODERNA,IM 922110,IL,61.0,F,"On 12/31/20 ,approximately, soreness to left deltoid region was present (expected). Redness, heat to site, burning, itching, pain began and steadily increased until 1-4-21 when I went to work at the hospital. On 1/4/21 increasesd symptoms continued with swelling to left arm deltoid both above and distal to injection site. Intensive symptoms continued. I applied cold compress intermittently, took ibuprofen and Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,WRK,"Levothyroxine Beta blocker Ibuprofen, Tylenol",None,None,,Tetracycline Sulfa drugs Thimerasol Bee stings,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Peripheral swelling']",1,MODERNA,IM 922111,KS,37.0,F,"Facial swelling/tingling, lip swelling and tingling and tongue swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/21/2020,3.0,OTH,Sprintec,None,"History of ulcerative colitis as a child, no medications since childhood. Times reported may not be exact to the minute as they are based on memory.",,None,"['Lip swelling', 'Paraesthesia', 'Swelling face', 'Swollen tongue']",1,PFIZER\BIONTECH,SYR 922112,FL,37.0,F,"8 days after vaccination I developed itching, erythema, warmth and induration at site and distal to injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,PVT,"Multivitamin, biotin",None,None,,None,"['Injection site erythema', 'Injection site induration', 'Injection site warmth', 'Pruritus']",1,MODERNA,IM 922113,,29.0,F,"Woke up in the middle of the night with severe chills and body aches. Eventually my symptoms lessened throughout the day (I did use analgesics), but still had chills, some achiness, and a headache the day after I received my vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,,,,,,"['Chills', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 922114,CA,29.0,M,"Pain and soreness at injection site beginning 5 hours post injection. At 3am on Jan 5th intense chills/sensitivity to temperature, coughing, waves of nausea, headache, and significant joint paint in arms, hands, and knees. Symptoms persisted until roughly 3pm that same day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,SEN,,COVID-19 (December 14th-28th),Exercise-induced asthma,,,"['Arthralgia', 'Chills', 'Cough', 'Headache', 'Injection site discomfort', 'Injection site pain', 'Nausea']",1,PFIZER\BIONTECH,SYR 922115,WI,33.0,F,"Rash at site of injection, onset - after day 8 of vaccine. 2 distinct patches of erythema, slightly raised. On day 3 after rash developed, there is some central clearing.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/03/2021,10.0,WRK,none,none,cholelithiasis,,none,"['Injection site erythema', 'Injection site rash']",1,MODERNA,IM 922116,AZ,57.0,F,Dizzy-hives chest and back-benydryl 50 mg-Called 911-trouble staying alert-ER steroids'. I have been on benydryl for 7 days now- when I try to wean off- I get a rash and migraines and trouble breathing . today day 7 I have weaned down to 8 hrs 25 mg from the 4 hrs,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,Vit C-Zinc-Vit D- C-Colloidal silver-probiotics-melatonin,none,Lupus-Sjogren's-cervical cancer,,Tetracycline- pineapple-walnuts-potatoes-gluten-dairy,"['Depressed level of consciousness', 'Dizziness', 'Dyspnoea', 'Migraine', 'Rash', 'Urticaria']",1,MODERNA,IM 922117,OK,52.0,F,1617 received the vaccine; 1633 began to c/o itching chest; seen by doctor; 1638 Benadryl 50mg IVP 1655 c/o less itching 1715 ok to leave,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Actoplus Met; simvastatin; Benazepril; Vit B 12; Vitamin C,allergies,diabetes and hypertension,,"Contrast dye, cats, dogs, seafood; laundry detergent; chocolate",['Pruritus'],1,MODERNA,IM 922118,GA,59.0,M,"After three days, couldn't sleep the whole night. The next day, went to work, came home felt jittery. Close to midnight bp 200/90. Took Clonidine 0.1 and went to ER, bp 180/90. waited for almost two hours bp came down to 141/80. Today, bp is back to normal. Took sleeping medication Zzzquil to go to sleep.",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/31/2020,01/03/2021,3.0,PVT,"Edarbyclor, Allopurinol, Apple Cider",no,High blood pressure,,Lisinopril,"['Blood pressure increased', 'Feeling jittery', 'Insomnia']",1,MODERNA,IM 922120,CA,38.0,F,"per pt. after covid vac. shot was given ,she fell palpitations and lightheadedness after few mins. receiving the vac.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,"codeine, penicillin class ,septra","['Dizziness', 'Electrocardiogram', 'Palpitations']",UNK,PFIZER\BIONTECH, 922121,NJ,63.0,F,"Bleeding sore on roof of mouth - causing discomfort with swallowing. Started day late afternoon 3rd day post injection. Bleeding stopped after a few minutes - some minimal blood when irritated post eating. As of today (5th day post injection), soreness in mouth seems to be resolving but discomfor on swallowing persists.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/03/2021,3.0,UNK,Calcium supplements; Vitamin D supplements; Fish oil supplements,none,osteoporosis; acid reflux/GERD,,none,"['Odynophagia', 'Stomatitis']",1,MODERNA,IM 922122,NJ,40.0,F,"Left arm numbness, hand numbness and pain, axilla pain/lymph node pain. I took tylenol and motrin 1 dose 1/5/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,PVT,"Tylenol, motrin-1/5/2021 Vitamin C 2000mg Zinc 50mg Vitamin D",None,None,,Shrimp,"['Axillary pain', 'Hypoaesthesia', 'Lymph node pain', 'Pain in extremity']",1,MODERNA,IM 922123,CA,39.0,F,"Patient describes Joint and muscle pain, itchiness and rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,"Tylenol, Ibueprofen, and Claritin and Benadryl",,,,,"['Arthralgia', 'Myalgia', 'Pruritus', 'Rash']",UNK,MODERNA, 922124,OH,50.0,M,"2 min after shot became dizzy, flushed, sweaty. Lasted 6-7 min. Arm soreness and extreme tiredness both for two days. Next day developed itching that progressed over several days. Rash/hives to upper chest, arms, and back started on day 3 after injection. Had to take Benadryl and vistaril initially then Doctor prescribed Prednisone on day six.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,SEN,"Claritin, Losartan, Buspar, Eye vitamin, osteoporosis-bioflex",None,"HTN, retinal detachments, kidney stones",,"PCN, Toradol, dust, and pet dander","['Dizziness', 'Fatigue', 'Flushing', 'Hyperhidrosis', 'Limb discomfort', 'Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 922125,NC,24.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Low grade fever of 99.4, chills, tiredness, injection site pain (couldn?t raise my arm for almost 24 hours), and feeling unwell. Most of my symptoms started over 24 hours after receiving the vaccine. I took Tylenol and Motrin to help with the pain and fever and used warm compresses to my neck and injection site. I also slept a lot. I just started feeling normal again after 2.5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,PVT,"Nexplanon implant, vitamin D supplement",,Chronic back pain,,Diced Supsension,"['Chills', 'Fatigue', 'Hypersomnia', 'Injected limb mobility decreased', 'Injection site pain', 'Malaise', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 922126,CA,42.0,M,Left axillary adenopathy,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/26/2020,3.0,WRK,"Pantoprazole, LOratadine, Albuterol, Omeprazole",,"Asthma, GERD","Influenza vaccine, age 41, unknown manufacturer",Shrimp,['Lymphadenopathy'],1,MODERNA,IM 922127,NY,,U,"Tennis ball sized rash at injection site including itchiness, redness and swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling']",1,MODERNA,SYR 922128,OH,40.0,F,"soreness at site 24 hours after injection with associated redness. redness expanded at day 7 and became itchy. 2 days after vaccine, had vaginal spotting. 6 days after vaccine painful swollen node under left arm. dysuria started 6 days after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"omeprazole, gianvi, cetirizine, symbicort, montelukast, vitamin D, probiotic, aspirin, Saxenda",none,"asthma, environmental allergies, reflux, obesity",,sulfa,"['Injection site discomfort', 'Injection site erythema', 'Injection site pruritus', 'Nodule', 'Vaginal haemorrhage']",1,MODERNA,IM 922129,TN,83.0,M,"Redness, bumps, minor burning pain limited to forehead and chin. Pt washed hair and applied lotion to mitigate the minor burning sensation. Pt advised he noticed onset at about 6 hours post injection on same day, Saturday, January 2, 2021. As of this date, burning and bumps have dissipated and redness is only minor. Photos from Sunday evening, Jan 3, 2021 and Tuesday evening, Jan 5, 2021 showing progression of symptoms, are available upon request.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,PUB,"atorvastatin 40mg, clopidogrel 75mg, metroprolol tartrate 25mg, multivitamin, vitamin D, losartan 50mg, levothyroxine 25mg, aspirin 81mg, Humalog insulin, Lantus insulin",chronic conditions listed below and treated by above listed meds,"insulin dependent type I diabetic, HBP, high cholesterol, see above meds list for typical approved indications",,none known,"['Burning sensation', 'Erythema', 'Heart rate increased', 'Hypertension', 'Rash']",1,MODERNA,SYR 922131,PA,31.0,M,"Constant tremors all over, equilibrium off, hypersensitive to noises, fatigue. No treatment. Still continuing",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,PVT,,None,Post-concussion syndrome - since 12/18,,"Amoxicillin, Keflex","['Balance disorder', 'Fatigue', 'Oversensing', 'Tremor']",UNK,PFIZER\BIONTECH,IM 922132,PR,47.0,F,"Two-inch area swollen, red, warm and painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,PUB,None,None,None,,None,"['Erythema', 'Pain', 'Skin warm', 'Swelling']",1,MODERNA,IM 922133,TX,36.0,M,Moderate pain and tenderness to arm. General weakness and malaise increasing past two days. Chills for past two days. No fever. Body aches.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,PVT,None,None,None,,Penicillin,"['Asthenia', 'Chills', 'Malaise', 'Pain', 'Pain in extremity', 'Tenderness']",1,MODERNA,IM 922134,NM,33.0,F,Patient had a weird taste in her back of her throat. Patient ate crackers and taste went away.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,['Dysgeusia'],1,PFIZER\BIONTECH,IM 922135,NY,50.0,M,"fever spiking to 101.8 orally, chills and aches lasting 4 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,UNK,omephrazol,none,none,,,"['Chills', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,SYR 922136,CO,32.0,F,"Red, swollen, sore arm around injection site. Hive-like appearance. Soreness through arm and neck and lat",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/04/2021,8.0,PVT,"Zofran, birth control, multivitamin",,,,"Latex, gluten, lactose","['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site urticaria', 'Myalgia', 'Neck pain', 'Pain in extremity']",1,MODERNA,IM 922137,ID,24.0,F,"1940: pt reported tingling and coldness in right fingers, no respiratory distress, no signs of allergic reaction, pt requested to go home and stated she was fine",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2020,01/05/2020,0.0,PVT,,,,,no severe reactions known,"['Paraesthesia', 'Peripheral coldness']",1,MODERNA,IM 922138,OR,28.0,F,Histamine reaction to first dose. Bright red circle around injection site with moderate itching.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,None,None,None,,Nickel,"['Hypersensitivity', 'Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 922140,SC,45.0,F,"7 days (4 Jan 21) after receiving the Covid-19 vaccine the injection site became red, swollen and hot to the touch. My skin feels like it is burning. I went to employee health the next day ( 5 Jan 21). The physician looked at it, tried to find pictures of reactions on the internet and then drew an ink pen line around the redness. Left an approximate 1/8th inch border. Told me to come back if it went past the lines. Within 12 hours it has swollen past the lines. My entire arm feels like it?s burning.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,None,None,None,,Allergies to several raw vegetables and fruits along with nuts.,"['Burning sensation', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Skin burning sensation']",1,MODERNA,SYR 922141,IA,45.0,F,"I had a swollen left arm , red, warm to touch for the first 3 days. arm was very sore on day #2. I had my shot on a Monday morning, by thursday my arm felt mostly fine, just a little sore. On Sunday evening, my arm started to react again at my injection site. Monday morning, red, hard, felt hot, about a quarter size. By Monday evening, about 5 inches of swelling in my arm and the red warm area was a half dollar size. By Tuesday morning it was twice that size. My arm and shoulder area are all sore at this point. I am taking 800 of Ibuprofen, Zyrtec and using cortisone ointment on my arm. Dr's at my hospital that I work with suggested that it meant i have had Covid recently, and already had antibodies, therefore having a stronger reaction. My Employee Health dept says that is not the case. They said to file a report here. They were also hoping this site would be able to tell me if can or should get the second vaccine. They aren't sure that I should.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,PVT,none,none,asthma environmental allergies (with allergy shot treatment) uterine fibroids,,penicillin biaxin zithromax,"['COVID-19', 'Injection site discomfort', 'Injection site erythema', 'Injection site joint discomfort', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 922142,TX,59.0,F,Moderna COVID-19 Vaccine EUA,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PUB,Atorvastatin 10 mg 1/day Vascepa 2 grams 2 tablets twice daily Metformin 500 Mg 1 tablet twice daily,none,"Type 2 diabetes, well controlled. A1C 6.0",,sulfa drugs; Bactrim,['COVID-19 immunisation'],1,MODERNA,SYR 922143,SD,57.0,F,"24 hours after vaccine I started feeling body aches, fever of 102.2 and chills. I went to bed and next day I had a sore throat, joint pain, body aches and slept all day. Fever lasted 18 hour (went down to 99.8 by morning). Symptoms lasted 36 hours. Was fine after that.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,WRK,Nature Throid for hypothyroid; biotin; D3; multivitamin; B-12; chlorella-spirulina,no.,hypothyroidism,,no.,"['Arthralgia', 'Chills', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'Somnolence']",1,PFIZER\BIONTECH,IM 922144,GA,55.0,F,I STARTED HAVING PAIN IN MY UPPER LEFT LEG AROUND 12/31 ..THE PAIN HAS WORSEN TODAY AND THE PAIN IS CAUSING ME TO LOSE MY BALANCE. IT FEELS LIKE ITS GOING TO GIVE OUT WHILE WALKING. THE PAIN TRAVELS DOWN MY WHOLE LEG. IF I STAND STILL OR SIT FOR A WHILE ITS HARD FOR ME TO PUT WEIGHT ON MY LEG. I HAVE NEVER HAD PAIN IN MY LEG LIKE THIS BEFORE. I WAS TOLD TO LET VSAFE KNOW DURING MY CHECK IN AND WILL CALL THE NURSE ON DUTY TONIGHT. IT'S BECOMING UNBEARABLE. I AM DUE FOR MY 2ND DOSE ON THE 8TH .,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/31/2020,9.0,PVT,AMLODIPINE 10MG,NONE,HIGH BLOOD PRESSURE,,NONE,"['Balance disorder', 'Gait disturbance', 'Pain in extremity', 'Weight bearing difficulty']",1,PFIZER\BIONTECH,IM 922145,CA,62.0,F,"Red rash on neck both sides below hyoid to scapula 6 inches from left to right and 3 inches top to bottom. Hot to touch, very red.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,OTH,"estrace; estradiol, prozac, synthroid, cytomel, calcitriol, melatonin, flax seed oil,",Shingles vaccine in Dec 5th maybe,thyroid removed CA; parathyroid removed,,"atorvastatin, codeine, lidocaine, morphine","['Rash', 'Rash erythematous', 'Skin warm']",1,PFIZER\BIONTECH,SYR 922146,NV,65.0,F,"On day 8 after the vaccine she developed an area of erythema, induration, itching and warmth about 5 cm in diameter at the site of the injection. On day 3 she finally took benadryl and ibuprofen and it started to resolve.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,UNK,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA, 922147,CA,48.0,F,"Patient was vaccinated at 9:21 am on 1/5/2021 after review of consent forms and questions answered. Patient was asked if she had any adverse reactions to vaccine or products containing polyethylene glycol ( bowel preps/ cosmetics/ lotions). Patient denied any allergies except to Penicillin. Patient consented to receive vaccine. Pfizer Covid vaccine administered at 9:21 am. No immediate reaction. Patient denied any pain at injection site. Patient escorted to observation area. At 9:30 am the patient complained of nausea and proceeded with dry heaves. Patient did state she had eaten in the morning. Patient with good radial pulses at rate of 88. Patient then stated she felt dizzy and patient was assisted to the floor and placed in a recovery position. The patient DID NOT have change in mental status or decrease in mental status. Initial BP 162/102 - HR 88. Patient continued with nausea, dry heaves and dizziness. 911 was called. Patient maintained a BP of 160-172 systolic and pulse rate of 120, RR 40. Patient WITHOUT rash, swelling, wheezing, SOB or change in LOC. Benadryl was administered at 0945. Medics arrived at 9:47. Patient was transported to local hospital. No change in patient status upon departure. Patient remained nauseated, with dry heaves and dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PUB,"Nifedipine, Topamax",No other illness reported.,HTN,,Penicillin,"['Dizziness', 'Nausea', 'Retching']",1,PFIZER\BIONTECH,IM 922148,MD,68.0,M,"Fever,101.3,muscle pain ,fatigue, sorethroat,heasach",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Vitamin d,None,"Hypertension, hyperlipidemia",,None,"['Fatigue', 'Headache', 'Myalgia', 'Oropharyngeal pain', 'Pyrexia']",UNK,MODERNA,SYR 922149,CT,46.0,M,"severe disabling pain at injection site (entire left shoulder) moderate to severe aches/fatigue/chills, only partially responsive to maximum dose NSAID symptoms lasted 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Injection site joint pain', 'Injection site pain', 'Pain']",1,MODERNA,IM 922151,WA,39.0,F,"48 hours after covid vaccine, acute onset neuralgia - nerve pain involving entire body (had shingles 1 year ago - same type pain but this time head to toe, comes and goes but consistent).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/04/2021,2.0,PVT,"PTU, lansoprazole, iron calcium zinc copper vit d",None,Graves/Hashimotos,,"Latex, chlorahexidine, methimazole",['Neuralgia'],1,PFIZER\BIONTECH,IM 922152,,83.0,F,"Patient had arm soreness for a few days following vaccine and mild redness for 1-2 days. On 1/4, she developed an area of redness at injection site, about 2.5"", warm to touch. She did not have a fever or pain. She was referred to urgent care for evaluation as unable to be seen by primary care office that day.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,01/04/2021,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site warmth', 'Limb discomfort']",1,MODERNA,IM 922153,PA,44.0,F,Lip/Mouth Edema,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,Liothyronine Levothyroxine Meclizine Pepcid Prilosec ASA Fish Oil,None,Hypothyroidism Palpitations Vit D Deficiency Cervical Disc Disease,,Darvon Demerol Imitrex,"['Lip oedema', 'Oedema mouth']",1,PFIZER\BIONTECH,IM 922155,OK,26.0,F,"received vaccine at 1635; 1648 rash noted on neck, right chest. Benadryl 50 mg IVP given 1652 c/o lightheadedness and palpitations Initial bp was 123/87-105 pulse and 20 respirations. At 1652 bp 151/79-128-20; 1720 nausea palpitations intermittently. 1725 134/72-104-20 and feeling fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Humira 80 mg weekly; prenatal vitamin,12/3/2020 covid tested negative,inflammatory arthritis,,contrast dye,"['Dizziness', 'Nausea', 'Palpitations', 'Rash']",1,MODERNA,IM 922156,AK,43.0,F,Became flushed and described a scratchy swallowing sensation. Blood pressure was elevated. SPO2 remained steady at 98%. Sat with healthcare staff for additional 40 minutes. Benadryl 25mg given.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,unknown,none,no,,denies,"['Blood pressure increased', 'Flushing', 'Throat irritation']",2,PFIZER\BIONTECH,IM 922157,TN,47.0,F,"Received Moderna Injection; Adverse Effects include Headache x 2 days, Soreness to Arm and unable to use for lifting/pushing/pulling x 2 days d/t increased pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PUB,"Estrace, Celexa, Zyrtec",Covid Positive 12/09/2020,,,"Sulfa, Biaxin, Bactrim","['Headache', 'Mobility decreased', 'Pain', 'Pain in extremity']",UNK,MODERNA,SYR 922158,OR,46.0,F,"Injected Moderna vaccine and within a few minutes, felt rushing feeling in center of chest, followed by dryness in throat, ""like something caught in my throat."" Administered liquid oral benadryl 50 mg. Hypertensive initially,130-140s/100s, HR 80-100. After 30 minutes, symptoms improved, returned to work at pharmacy on the same site where she received the vaccine. Symptoms in the afternoon were dull substernal chest discomfort. Denies hx of GERD. Repeated benadryl at 1626. Little improvement in substernal chest discomfort. Gave NTG 0.4 mg SL, with 324 chewable baby asa, initially felt flushed/hot, but then symptoms began to improve. Very resistant to go by ambulance to ER. Son able to provide transportation from clinic directly to another facility. Ambulatory upon d/c from clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,,,"Ramen, throat closed, unknown ingredient, not MSG.","['Chest discomfort', 'Chest pain', 'Dry throat', 'Electrocardiogram normal', 'Feeling abnormal', 'Feeling hot', 'Flushing', 'Hypertension', 'Immediate post-injection reaction', 'Sensation of foreign body']",1,MODERNA,IM 922159,FL,46.0,F,"Headache, muscle ache, body ache, some shortness of breath when talking and feeling very tired.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,WRK,Diltiazem 240 mg qd,none,none,,none,"['Dyspnoea', 'Fatigue', 'Headache', 'Myalgia', 'Pain']",1,MODERNA,IM 922160,ID,49.0,F,"1932: pt stated she felt uneasy, felt heart pounding, gave water and rest, declined BP, manual HR taken, HR: 112 bpm 1933: opened door for fresh air, BP:213/94, HR: 86, no rash or redness at site, does take BP medications daily but forgot today, pt stated she was anxious about coming and had a support person accompany her 1937: BP: 187/96, HR: 83, started to feel better, patient's husband went to car to get clonidine that is prescribed prn for patient, pt did not take at clinic 1940: continue to rest, denied BP retaken, stated heartbeat was normal, she felt good, pt will continue to do V Safe, rested and left at 1942, pt will continue to monitor symptoms and BP at home",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2020,01/05/2020,0.0,PVT,,,Hypertension,,,"['Anxiety', 'Feeling abnormal', 'Palpitations']",1,MODERNA,IM 922162,PA,19.0,F,"Moderna COVID-19 Vaccine EUA Very anxious prior to receiving first dose of Moderna Covid Vaccine. One hour after receiving vaccine complaint of itchy hands and felt as if ""ants were crawling all over her"". She said has an allergy to Latex and was previously wearing Lavender Nitrile gloves. No hives or erythema on exam, some mild erythema to area after scratching hands with nails, no raised wheals. Sensation of pruritis spread to back and neck without urticaria. Diphenhydramine 50mg was administered. Approximately 30 minutes patient complained of nausea and was give Ondansetron 4mg which alleviated nausea. Pruritis resolved but approx 30 min patient began to feel tired, dizzy and lightheaded. Vitals were taken and orthostatic blood pressures were performed. All vitals were normal, oxygen saturation was normal and injection site was without erythema and no evidence of urticaria. Physical exam was also performed and no abnormalities to heart or lungs were auscultated.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Topimax, Norethindrone, Lexapro",Sinus Infection,"Migraine, Irritable Bowel Syndrome, Eczema, Panic Disorder, Anxiety, Major Depressive Disorder, Hip Dysplasia, Chondromalacia of left knee, Mild Intermittent Asthma, Lactose Intolerance. Covid positive 10/01/2020",Prevnar 7 as an infant developed high fever with second dose,"Penicillin, Latex, Banana","['Anxiety', 'Dizziness', 'Erythema', 'Fatigue', 'Formication', 'Pruritus']",1,MODERNA,IM 922163,PA,49.0,F,"30 minutes after receiving the injection, I started having a dry cough, brought on by bronchial spasms. The cough and spasms are ongoing 24 hours later. I then developed significant pain at the injection site three hours after, which has continued through the 24 hours that has gone by. At 12 hours post-injection, I began to have myalgia, fatigue, headache and chills. I used 1000mg of Tylenol at the 16 hour mark, with moderate relief. When the Tylenol wore off, all symptoms returned in full. I am now 26 hours post-injection, and still having all symptoms previously mentioned. At no time, before or after taking Tylenol, did my temperature go above 98.5",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Adderall XR Warfarin Pepcid Levothyroxine,None,Factor V Lieden Hypothyroidism,,None,"['Bronchospasm', 'Chills', 'Cough', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia']",1,MODERNA,IM 922164,,35.0,F,Swelling and itching to injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,12/30/2020,6.0,WRK,,,,,,"['Injection site pruritus', 'Injection site swelling']",UNK,MODERNA, 922165,TX,38.0,F,"Moderna COVID-19 Vaccine EUA consistent elevated bpm 80-147, chest pain, shortness of breath, dizziness, fatigue day 1 to current day 6. Severe body aches on day 1. Bilateral axillary lymph node swelling and tenderness day 2 to current day 6.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,Effexor 150mg,,,,"no allergies to medications, food, or other products","['Blood pressure increased', 'Blood test normal', 'Chest pain', 'Dizziness', 'Dyspnoea', 'Electrocardiogram normal', 'Fatigue', 'Lymph node pain', 'Lymphadenopathy', 'Pain']",1,MODERNA,IM 922166,AZ,37.0,M,"Follow-up from outside facility?: No patient reports he received the covid vaccine at 1710 and at 1720 started having chest tightness that would be sharp and then relax. 37yo MALE, Chief Complaint: Visit CC: CP, after getting covid vaccine Vital Signs: HT:72.00 (182.88 cm), TMP:98.10 (36.7 C)[ORAL], PU:75, RS:17, BP:143/97, WT:209.99 (95.34 kg), BMI:28.48, PA:2, O2:98[AMBIENT AIR l/min %] LMP:Patient is male O2 Sat on RA? Yes INTERVENTIONS No Interventions performed. Chronic Problems: 1)Muscle tension - -QUALIFIERS: Severity Moderate Clinical course Chronic persistent OBJECTIVE ASSESSMENT No observable symptoms Pain Documentation: Level of Pain: 2 (Dec 30, 2020@17:37) Pain Location: chest Onset: HPI: Patient is a 37-year-old male with no significant past medical history who presents for evaluation of chest tightness. He reports that symptoms started 10 minutes after getting the Covid vaccine prior to arrival. He reports that his chest tightness is intermittent and has been gradually improving. He denies associated shortness of breath, nausea or vomiting. He denies any recent illnesses.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,CYCLOBENZAPRINE 10MG TAB *SKPR* TAKE ONE (1) TABLET BY ACTIVE MOUTH AT BEDTIME IF NEEDED FOR RELIEF OF MUSCLE NAPROXEN 250MG TAB *SKPR* TAKE ONE (1) TABLET BY MOUTH ACTIVE TWICE A DAY FOR PAIN RELIEF-TAKE WITH FOOD,,,,nka,"['Chest discomfort', 'Chest pain', 'Electrocardiogram normal', 'Muscle tightness']",1,MODERNA,IM 922168,PA,49.0,F,I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes after getting the vaccine. Twice while I drove back to work and twice while I was working. These episodes were brief. I also experienced numbness and tingling in my arm that received the injection. This feeling spread to my shoulder and traveled up my neck to my face. I had numbness and tingling on my left side of my face and lower lip. This lasted till about 3:30 pm and then went away. Tonight around 7:00 pm I am still experiencing some numbness and tingling on my face and lip which comes and goes. I am having soreness in my arm at the injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Montelukast 10 mg 1 tab/day Xarelto 20 mg 1 tab/day Flecainide 50 mg 2 tabs/day Omeprazole 20 mg 1 tab/day Atenolol 25 mg 1 tab/day Losartan 100 mg 1 tab/day Vitamin D 2000mg 1 tab/day Albuterol 90 mcg inhalation powder PRN Flonase Sensimis,none,SVT Heart palpitations Hypertension DVT and PE Hyperlipidemia Asthma GERD Osteoarthritis Raynauds syndrome Allergic rhinitis Morbid obesity Iron deficiency anemia,,Avelox-anaphylaxis,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Injection site pain', 'Palpitations', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 922169,NY,24.0,F,Painful rash on neck with hives @ 2000. Took 2 Benadryl @ 2030.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,Paxil Vitamin D3,,,,,"['Rash', 'Urticaria']",1,MODERNA,IM 922170,MA,53.0,M,Around 2 inch lump at the injection site about 5 days after first injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/01/2021,4.0,OTH,None,,,,PCN- Anaphylaxis,['Injection site mass'],1,MODERNA,IM 922171,NY,31.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Fever up to 101.0 degrees Fahrenheit for several hours, which reduced with Tylenol and ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,,,,,,['Pyrexia'],2,PFIZER\BIONTECH,IM 922173,OR,34.0,F,"Facial swelling, rash on face, knees, and top of feet starting 2 hours post vaccine, subsiding over the course of 8 hours with ongoing mild facial rash",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,None,None,None,,"Shellfish, iodine","['Rash', 'Swelling face']",1,MODERNA, 922174,ID,32.0,F,About 5-10 minutes later patient began to have metallic taste in her mouth. She began to feel warm. Also began to feel some burning in her upper chest. Patient denies any swelling in her throat. She denied any difficulty swallowing or breathing. Patient does have history of a mini stroke in the past. Patient states since then she is become hypersensitive to phalanx. She denies any known allergies. She denies any allergies to any injectables or any vaccines. No known food allergies. No medication allergies. Patient denies any known history of panic attacks. Patient was questioning if this may be a panic attack.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Chest pain', 'Dysgeusia', 'Feeling hot']",1,MODERNA,IM 922175,MD,20.0,F,"Right arm numbness, cold feeling. Right sided facial numbness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Vitamin D supplement, Iron pills.","1wk ago- fever, body aches, nausea. Had negative COVID test.","anemia, joint pain",,Sulfa drugs= throat swells as a child,"['Feeling cold', 'Hypoaesthesia']",1,PFIZER\BIONTECH,IM 922176,TX,48.0,F,"Injection site swelling with no pain two weeks after vaccine. The day after the injection, I had injection site swelling for about three days then it went away.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/05/2021,10.0,PUB,"Crestor, vitamin d",,,,,['Injection site swelling'],1,MODERNA, 922177,CT,28.0,M,"Aseptic meningitis, prolonged fever for more than a week, headache, elevated transaminase (ALT is 124). Lumbar tap showed elevated WBC of 23, 76% polys and 24% mononuclear, 25 RBC. Glucose and protein are normal. CSF PCR viral panel is negative. Patient was initially given Acyclovir and was stopped when HSV and VZV PCR were negative. He was given vancomycin IV for Gram positive bacteremia which was later stopped because it was deemed a contaminant.",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,12/26/2020,12/26/2020,0.0,PVT,none,none,none,,none,"['Alanine aminotransferase increased', 'Borrelia test negative', 'CSF culture negative', 'CSF glucose normal', 'CSF mononuclear cell count increased', 'CSF polymorphonuclear cell count increased', 'CSF protein normal', 'CSF red blood cell count positive', 'CSF virus no organisms observed', 'CSF white blood cell count increased', 'Cryptococcus test', 'HIV test negative', 'Headache', 'Hepatitis A virus test', 'Hepatitis B test negative', 'Hepatitis C test negative', 'Herpes simplex test negative', 'Influenza virus test negative', 'Magnetic resonance imaging brain normal', 'Meningitis aseptic', 'Mononucleosis heterophile test negative', 'Polymerase chain reaction', 'Pyrexia', 'SARS-CoV-2 test negative', 'Staphylococcus test positive', 'Treponema test negative', 'Varicella virus test negative']",1,MODERNA,IM 922178,CA,31.0,F,"Moderna- initial arm pain, headache, flushing for first few hours but resolved However, today, 1 full week later, now have new onset redness, swelling and pain to site of injection Have also had neck pain, feeling of neck strain the last few days on same side as infection, but am not sure it is attributed, started 2 days after vaccine .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,None,None,None,,None,"['Flushing', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Muscle strain', 'Neck pain', 'Pain in extremity']",1,MODERNA,IM 922181,TX,28.0,F,"On 1/4/21 the event follows: 11:37am I got the vaccine 11:50am I got symptoms of tingling with numbness in lips and fiery hot in injection site 12:00pm tingling in left arm below injection site to finger tips 12:20pm felt like my arm was asleep 12:54pm I was given diphenhydramine (Benadryl), fatotidine (Pepcid), and prednisone (deltasone) 1:25pm my left shoulder moving up my neck behind left ear started having pain 1:40pm I was given ibuprofen (Motrin) 2:28pm I was told the symptoms left were known/normal and I am to watch symptoms and take Motrin and Tylenol as needed. Around 4pm made it home and went to sleep. 9:20pm I woke up pain was minimal and went back to sleep. On 1/5/21 I woke up @6:35am and pain was minimal in injection site no other symptoms. Throughout the day I started feeling more pain but was bearable. @6pm my arm was in pain and hurt to touch @7pm I decided to look at my arm and noticed a red ring around injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,None,None,"Asthma, and PCOS",,None,"['Arthralgia', 'Blood glucose', 'Hypoaesthesia oral', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Limb discomfort', 'Neck pain', 'Pain in extremity', 'Pain of skin', 'Paraesthesia', 'Paraesthesia oral']",1,MODERNA,SYR 922182,IN,82.0,F,"1. She was found with her skirt up around her neck and normally is oriented 2. Speech slightly off 3. Left sided facial drooping 4. At time of EMS transfer BP 156/22, P 118, R 18, Temp 104",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,SEN,,,,,,"['Body temperature increased', 'Disorientation', 'Facial paralysis', 'Speech disorder']",1,MODERNA,IM 922183,IL,51.0,F,"Dizziness, extreme joint paint( almost unable to walk, nausea and fatigue lasting 2 days full on and mild symptoms for 3 days following",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PUB,"Simvastatin 20, escitalipram, zinc, vitamin b, oxybutin,",Na,Na,,"Strawberries, red dye,","['Arthralgia', 'Dizziness', 'Fatigue', 'Gait disturbance', 'Nausea']",UNK,MODERNA, 922185,CA,30.0,M,"Sporadic vesicular rash and intense pruritus. Rash started as small 1 cm diameter wheal on left forearm at wrist then progressed to small 5 cm or less vesicular rash on various spots of the body, bilateral arms, legs, chest and abdomen. Spared mucosa and palms/soles/scalp",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,MIL,None,Minor gastroenteritis for one day a week prior to illness,None,,None,"['Pruritus', 'Rash', 'Rash vesicular', 'Urticaria']",1,MODERNA,IM 922186,NM,66.0,F,"Starting the day after vaccine I have had extreme fatigue, nausea, decreased appetite. dizziness, muscle aches, chills. It has continued now for 14 days, without improvement. It is actually worsening.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,Pramipexole Trazodone,None,None,,None,"['Chills', 'Decreased appetite', 'Dizziness', 'Fatigue', 'Myalgia', 'Nausea']",1,PFIZER\BIONTECH,IM 922187,TX,52.0,F,"Approx 20 minutes after injection had "" tickle in throat "" and slight increase in cough then pruritus approx 1 inch distal to injection site. Approx 30 minutes after injection the Extensor surface of rt arm developed redness with ongoing itching.. Heat in rash with some swelling. Redness, itching and swelling on chin, lower face and sternum at 35 minutes. Diffuse pruritus of both arms. Took claritin 20 mg + pepcid. Itching improved in arms and redness started to resolve. Still with ""tickle in throat"" and subjective sensation of slight facial swelling. Started dexamethasone 8 mg po + singulair 10 mg + xyzal. Rash resolved but cough originating in throat persisted slightly. Symptoms resolved by the next morning. Note: I am a family practice Physician Assistant. I have never had this type of reaction after an injection but am feeling fine now. Symptoms pale in comparison to COVID issues.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PHM,Wellbutrin 150 mg a day. Flonase NS,None,Mild asthma Migraines Mild depression- in remission Remoted history of pressure urticaria and dermatographism,,sulfa - rash Demoral- confusion,"['Cough', 'Erythema', 'Injection site pruritus', 'Pruritus', 'Skin warm', 'Swelling', 'Swelling face', 'Throat irritation']",UNK,MODERNA,IM 922188,CO,41.0,F,"Headache started during the night, contacted PCP and was advised taking Tylenol was ok. Took Tylenol at 10am, it subsided and ended around 5pm. Experienced sluggishness and feeling tired all day. Some brain fog of having to concentrate for long period of time. Nausea started in the morning and has continued throughout the day. Lack of appetite. Sore arm started evening of the 4th, pain continues 24 hrs later but it is getting better.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PHM,150mg Zoloft daily Nexplanon Norethindrone Super Lysine,None,Migraines,,Codeine Neosporin,"['Decreased appetite', 'Disturbance in attention', 'Fatigue', 'Feeling abnormal', 'Headache', 'Nausea', 'Pain in extremity', 'Sluggishness']",1,MODERNA,SYR 922189,OK,28.0,M,"Subjective fever/chills, headache, generalized body aches, soreness in L deltoid (injection site) for ~4-6 hours overnight, with only mild headache and arm soreness the following morning. Resolved by the following mid-day, approx. 24 hrs post-injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,None,"Recent mild symptomatic COVID infection (initial Sx on 12/11, first positive 12/14, return to work 12/21)",None,,None,"['Chills', 'Headache', 'Injection site pain', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 922190,CA,49.0,F,"patient came to observation room to start observation at 909, at 920 patient asked nurse for help. patient stated that her belly was warm, she felt hot and that she felt dizzy. Nurse leaned patient back and placed feet on chair. Oxygen at 3 l applied via nonrebreather. Nurse asked patient about history of possible anxiety. Patient stated she takes something everyday for it and that she has hx of it. Patient stated she felt much better once oxygen was on. Patient does not wear oxygen at home. Oxygen was removed at 940 and at 955 patient was discharge from observation after stating she felt absolutely fine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,None reported,Patient reported h/o of anxiety.,,None reported,"['Abdominal discomfort', 'Dizziness', 'Feeling hot']",1,MODERNA,IM 922191,OR,50.0,M,Patient began to appear flushed and sweaty. Was unable to speak clearly. Patient was placed in a wheel chair and taken to the Emergency Dept.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,* Duloxetine * Epi-Pen,,Anaphylaxis to shellfish Hyperlipidemia Family history of schizophrenia,,Shllfish containing products Iodine,"['Flushing', 'Hyperhidrosis', 'Speech disorder']",1,MODERNA,IM 922192,RI,62.0,F,"6 to 7 minutes after vaccine felt flu like symptoms then could taste medicine. Breathing seemed to slow down, blood pressure went to 140/90 and always have low blood pressure then tongue felt numb. I work at a hospital so they took me to the ER",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,WRK,Symstatin,None,None,,None,"['Dysgeusia', 'Hypoaesthesia oral', 'Influenza like illness', 'Respiratory rate decreased']",UNK,PFIZER\BIONTECH,SYR 922193,WA,28.0,F,"Around 12 hours post-vaccination with the 2nd dose, noticed severe chills, fatigue, headache, and full-body myalgias. Severe chills lasted ~6 hours, then subsided. Severe fatigue continued for ~24 hours (still feeling fatigued, but it is improving). Milder chills continued for ~24 hours but have mostly subsided. Headache and myalgias have improved over the last 24 hours but are still present despite use of ibuprofen 200mg Q6H.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,-aspirin 81mg QD -Lo-loestrin 1 tab QD -trazodone 25mg HS -spironolactone 25mg QD,No illnesses for ~2 years prior to vaccination,-insomnia -cystic acne,Moderate injection site soreness with 1st COVID vaccine,NKDA. Allergic to cats and pollen,"['Chills', 'Fatigue', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH,IM 922194,WI,60.0,F,"Vomiting, chills, headache. Began 18 hours post injection. Lasted for 12 hours. Continued to have chills and excessives sleepiness for 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,PVT,"Bupropion , lamotrigine",None,Left beta block heart,,None,"['Chills', 'Headache', 'Somnolence', 'Vomiting']",1,PFIZER\BIONTECH,IM 922195,CT,31.0,F,"I had the vaccine on 12/28/20 and I had soreness (which I know is normal), but today, 01/05/21, I noticed that I have a red raised area at the site of the injection; I am a PA and I would describe it as a red circular area of induration that is tender to the touch.I believe this is a common side effect and I have heard from a few other people that have reported this side effect, but I wanted to report it because I am not sure when it started and it has been a week since I got the vaccine. My arm was sore for the first few days after the injection, but then the soreness got better. I hadn't really looked at my arm closely since the day after the vaccine, so I am not sure if it was there before. I was not able to report this on the CDC v-safe website because it has been over a week and I stopped getting the daily check-in links. I am not sure if I will get another link for 1 week. This is why I am sending this here.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,"Vitamin D 1000 U, Vitamin C 500 mg, Seroquel 50 mg daily, Depakote 500 mg 2 tablets daily, Lamictal 150 mg daily",None,Bipolar disorder,,Amoxicillin,"['Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Pain in extremity', 'Pain of skin']",UNK,MODERNA, 922196,TX,21.0,F,"sudden itchiness on area surrounding injection site at night after 1.5 week of injection and continue to persist for the following days, a small red bump, the area around the injection site the size of a small child?s palm is pink/light red in color",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/03/2021,8.0,PHM,none,none,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 922197,FL,61.0,M,Fever 102+ and Chills for two consecutive nights,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Pyrexia']",UNK,MODERNA, 922198,MS,34.0,F,"Moderna COVID-19 Vaccine EUA Fever 101.9, Body aches, chills, Fatigue 28 hours after I received the vaccine. I also had a lot of pain at the Injection site for 72 hours after I received the vaccine. I took some ibuprofen and it helped.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,Synthroid 100mcg one po daily,,Hypothyroidism,,,"['Chills', 'Fatigue', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 922199,CT,65.0,F,20-30 minutes after the shot I started feeling tightness in my face and I felt like it was swollen. And eyes started feeling puffy especially my left one but when I looked in the mirror nothing was swollen. About 30 minutes later I took a Benadryl. It started feeling better but the sensation took about 24 hours to go away totally on my face and a few hours later for my eyes to feel normal.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Atenenol,None,High blood pressure,Shingles. 11/2019. Flu like symptoms,"Sensitivity to certain fruits,smoke,smells. Lose my voice,sometimes scratchy throat but not considered an allergy by doctors","['Periorbital swelling', 'Skin tightness', 'Swelling face']",1,MODERNA,SYR 922200,MA,36.0,F,"I woke up the morning following my first dose of the COVID 19 vaccine feeling very lethargic, tremulous and achy. I felt like my heart rate has been rapid all day and my rate of breathing has been slightly increased. The pain in my left arm, where I was given the injection is very sore to the point where it is difficult to lift or to touch. I was too weak to attempt to go to follow up with medical professionals today and opted to wait to see if symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Meloxicam,,Back and hip pain (torn labrum) post injury in May of 2020 Right meniscus repair Fall of 2020,,,"['Asthenia', 'Heart rate increased', 'Lethargy', 'Mobility decreased', 'Pain', 'Pain in extremity', 'Pain of skin', 'Respiratory rate increased', 'Tremor']",1,MODERNA,IM 922201,CO,42.0,F,"1/5/20 @ 1:30 pm symptoms of systemic itching, itching in throat, throat irritation, lightheadedness, nausea and increased phylum in throat.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,SCH,Unknown,,,,flax seeds,"['Dizziness', 'Nausea', 'Productive cough', 'Pruritus', 'Throat irritation']",1,MODERNA,IM 922202,MN,61.0,M,Severe Fatigue lasting for 6 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,SEN,None,None,None,,Dilantin,['Fatigue'],UNK,MODERNA, 922203,OH,63.0,F,Had itchy throat scratchy voice burning in chest lightheaded and elevated BP 10 minutes after injection. Next day pain and left arm and injection site blood pressure remains elevated and lightheadedness Next day still pain in arm elevated blood pressure nausea Headache and still have all symptoms 7 days later except pain at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,Lisinopril 10 mg daily Alive multivitamin Doxycycline 50 mg daily,None,Hypertension,Flu vaccination in 1997 and 1998 had flu symptoms for 3 days after 1997 and flu symptoms for 5 days after 1998,Sulfa Penicillin Erythromycin Shellfish,"['Blood pressure increased', 'Chest pain', 'Dizziness', 'Dysphonia', 'Headache', 'Injection site pain', 'Nausea', 'Pain in extremity', 'Throat irritation']",1,MODERNA,SYR 922204,CO,29.0,F,"1 week post injection, my injection site began to swell and a red welt has appeared. It is warm to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,Promethazine,,Endolymphatic hydrops,,"Penicillin, Sulfas, Bactrim, Clindamycin","['Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Urticaria']",1,MODERNA,SYR 922205,UT,48.0,F,"Aside from mild ache in left arm on day #2 following vaccine, which I reported via app, I had no symptoms at all until 1 week & 8 hours following vaccine (night of 1/4/21) Then I noticed a palpable but barely visible lump or knot in my left deltoid region but about 2cm anterior to the vaccination site. The next morning (1/5/2021) I developed a 4x8cm area of redness, mild swelling, & warmth. It is not pruritic or painful. It has not changed all day. Though my CGM sensor is also now on my left arm, it is not near that. I have no fevers, don't feel sick or have hyperglycemia to suggest cellulitis. No itching, or bite marks or other lesions to suggest an insect bite. I am reporting because I have never heard of such a reaction so long after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PUB,Novorapid insulin via Tandem T-slim insulin pump along with Dexcom GCM. Aspirin 81mg once daily. Atorvastatin 10mg once daily. Loratadine 10mg once daily.,None,"Type I diabetes, migraines, allergic rhinits",,None,"['Injection site erythema', 'Pain in extremity', 'Vaccination site mass', 'Vaccination site swelling', 'Vaccination site warmth']",1,MODERNA,IM 922206,OH,62.0,M,"Arm weakness increased each day by post vaccine day 4 arm weak and unable to raise arm, conduct ADLs, painful interrupting sleep. Unable to initiate movement in arm. Use other arm to help move arm. Went to ED on post vaccine day 4. Wbc 12. Crp 4. CT no abscess. Mri on 1/4 shows bursitis. DX SIRVA. Bursa aspirated. Pending cultures. PO MEDROL DOSEPAK.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/28/2020,12/29/2020,1.0,PVT,Eliquis micardis. Metoprolol crestor asa,None,CAD Afib,,Nkda,"['Aspiration bursa', 'Bursitis', 'C-reactive protein increased', 'Computerised tomogram normal', 'Culture', 'Loss of personal independence in daily activities', 'Magnetic resonance imaging abnormal', 'Mobility decreased', 'Muscular weakness', 'Pain in extremity', 'Shoulder injury related to vaccine administration', 'Sleep disorder', 'White blood cell count increased']",1,MODERNA,IM 922207,,35.0,F,Redness around injection site - larger than a half dollar sized and swelling/tenderness,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,PFIZER\BIONTECH,IM 922208,IN,33.0,F,"I had a localized skin reaction for 2-3 days after receiving vaccine ( redness, itching, swelling at and around injection site), which went away after a few days. Today (9 days after vaccine) my skin reaction has returned and is more prevalent than it was the first time. It is very red, swollen, itchy, and hot to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,PVT,"Cimzia, hydroxychloroquine, levothyroxine, folic acid, prenatal, Zyrtec, biotin, vitamin D3",None,Rheumatoid arthritis Hypothyroidism,,Sulfa,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Skin reaction']",1,PFIZER\BIONTECH,IM 922209,,41.0,M,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,Atorovastatin,,High cholesterol,,,['Headache'],UNK,MODERNA,IM 922211,CA,48.0,F,"Pt. experienced itchiness, rash, swollen face, chest tightness, swollen hands, headache. Took Benadryl to relieve the itchiness. continued to have tightness in the chest. Still experiencing these side effects 24 hours later.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,,,,,"Sulfa , cats","['Chest discomfort', 'Headache', 'Peripheral swelling', 'Pruritus', 'Rash', 'Swelling face']",1,MODERNA,IM 922212,TX,48.0,F,"Temp 102.4, chills, generalized pain",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,WRK,"Lexapro, vit D, estrace, progesterone",None,None,,Flagyl,"['Body temperature increased', 'Chills', 'Pain']",1,MODERNA,SYR 922213,CO,42.0,F,"1/5/21 @ 1:30 pm symptoms: systemic itching, itching and increased phylum in throat, nausea, lightheadedness. Symptoms increased overtime and treatment listed below before transported by ambulance to hospital 1:30 pm benadryl 50 mg po 14:58 epinephrine 0.3 ml (1:1000) sq 15:40 epinephrine 0.3 ml (1:1000) sq",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,SCH,,none,none,,flax seeds,"['Dizziness', 'Nausea', 'Productive cough', 'Pruritus']",1,MODERNA,IM 922214,CO,41.0,F,"Itchy, raised up rash, hot to the touch. Outlined rash 2 times and both times rash exceeded outline, rapidly. 1st time it appeared was on date 9. Today it has returned larger and its day 13 today. Today just itchy. Almost entire left humerus is covered in rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/01/2021,8.0,PVT,Nikki 3mg/0.02 mg,NONE,NO,,NONE,"['Rash', 'Rash papular', 'Rash pruritic', 'Skin warm']",1,MODERNA,SYR 922215,WA,54.0,F,"Most were on the list or have heard others speak of: various aches, diarrhea, injection site pain (still ongoing). Although lymph node swelling/tenderness was mentioned, I had pain deep in my armpit and lympadema extending from shoulder to wrist. I've used a TENS unit crossing the armpit area to stimulate the lymph nodes, massaged and ace wrapped the arm. The swelling has gone down but is not fully back to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PVT,Duloxetine Multi-vitamin,None,"Spinal instability, severe artritis right knee, narcolepsy",,"Phenobarbitol, nortriptaline, possibly nutmeg","['Axillary pain', 'Diarrhoea', 'Injection site pain', 'Lymph node pain', 'Lymphadenopathy', 'Lymphoedema', 'Pain', 'Pain in extremity']",1,MODERNA,UN 922216,OR,35.0,F,"1630 PT HAVING ITCHING AND FEELING HOT AND DIAPHORETIC POST VACCINATION. 1645 HYPERTENSIVE 169/115, HR 88. RAPID RESPONSE TEAM CALLED. PT WITH ICE PACK TO NECK AND GIVEN WATER TO DRINK. CONTINUES TO FEEL ITCHY AND HOT. 1657 178/115 BP REMAINS HYPERTENSIVE AND CONTINUES WITH ITCHING AND FEELING HOT AND ANXIOUS. 1710 REMAINS HYPERTENSIVE AND ITCHING. PT RELAXING TAKING WATER. 1730 PT REMAINS HYPERTENSIVE BUT REFUSES FURTHER TREATMENT BP 175/112. WANTING TO GO HOME. NO FURTHER TREATMENT GIVEN. INSTRUCTED TO GO TO ER OR NOTIFY MEDICAL PERSONEL IF CONDITION PERSISTS/WORSENS",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,NONE NOTED,,,,UNKNOWN,"['Anxiety', 'Feeling hot', 'Hyperhidrosis', 'Hypertension', 'Pruritus']",1,MODERNA,IM 922217,TX,38.0,F,"Mild headache starting on Saturday evening around 7:00pm, January 2nd, took 3 ibuprofen, Sunday morning, January 3rd, woke up around 10-11am body aches, headache, fatigue, swollen lymph node under left arm pit, took 3 ibuprofen around 12:00pm. Headache and body aches subsided slightly but never fully gone. Around 6:00pm -7:00 low grade fever and chills, took 3 ibuprofen around 8:00pm. Body aches and fatigue continued to Monday, January 4th, but was reduced in severity, took 3 ibuprofen around 10:00am. All symptoms with exception of swollen lymph node and heat/swelling/pain at injection site are now gone by Tuesday January 5th.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,,"Sinus infection, started December 20, 2020, started antibiotics December 23, 2020 for 10 days",,,Sulfa based medications,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Lymphadenopathy', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 922218,CO,41.0,F,"3 Days after the covid vaccine. I Started to have these symptoms around 1am: fever, chills, body aches, cold sweats. I took ibuprofen fell asleep. Around 330am. Woke up with dizziness, headache, chills. Took tylenol. Fell asleep body was extremely cold esp hands and feet. Woke up around 7am. Still had severe body aches and was extremely dizzy, headache worsening. Took ibuprofen. Woke up around noon. Extremely dizzy with chills and body aches headache still severe. Took tylenol. I was not getting better. went to hospital . It was found I had extremely high wbc and had extremely low blood pressure. Diagnosed as septic shock.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,12/23/2020,12/26/2020,3.0,PUB,Entyvio,,Crohns disease,,,"['Chills', 'Cold sweat', 'Dizziness', 'Feeling cold', 'Headache', 'Hypotension', 'Pain', 'Peripheral coldness', 'Pyrexia', 'Septic shock', 'White blood cell count increased']",1,MODERNA,IM 922219,WA,35.0,F,"Received Covid vaccine on 1/31/20 at 10:15 am. Went to bed. Woke at 3:00 am with both feet and calves ached. The pain decreased throughout the day. On 1/2/21, my right foot and leg were fine and pain has not returned since then. My left foot, ankle, and shin hurt pain level 2 of 10 on and off all day. Same on 1/3/21. On 1/4/21 the left leg, ankle, and foot hurt 7 of 10. Same on 15/2021. The pain seems to be moving upwards, almost to my knee at times. The pain is usually an ache all over the left food, ankle, shin. Sometimes I get sharp jabs of pain while sitting or walking. Aleve sometimes helps. Heat pad made it worse. Cold pad made it a little better.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,,,,,,"['Arthralgia', 'Pain', 'Pain in extremity']",1,MODERNA,SYR 922221,CA,29.0,F,woke up on day 7 with a red 4 inch red raised mark (cellulitis) at injection site. Progressing to cellulitis ring around injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,PVT,"multivitamin, echinachea, vitamin c, probiotic, OCP.",,,,iodine contrast.,"['Injection site cellulitis', 'Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 922222,PA,53.0,F,"On 12/28 started with itchy rash on left side of body. Arm, hand, leg, foot. Then started on lips and inside mouth. Did go to left arm. Started on prednisone 12/31 prescribed by my PCP. Using pepcid and Zyrtec as well as benadryl cream. Have completed 5 days of 30mg prednisone and 1 day of 20mg prednisone and rash remains. Continues to itch. Mouth is better but left side of body no better. Did have shot in left arm. Have changed nothing and no new food. Spoke to several doctors at the hospital that I work at and they are worried that it is from covid vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/28/2020,7.0,PVT,"Tegretol, Protonix, Pepcid, Wellbutrin, Prozac, Tylenol, Ajovy shot",None,"Migraines, Stomach issues, IBS",,"Demerol, Dilaudid, Morphine, PCN, Tequin, Doxycycline, Ativan,","['Rash', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 922223,DC,51.0,M,Pain at injection site with increased pain around the deltoid region starting 24 hours after injection and lasting for 48 hours. The deltoid was hot to the touch during the increased pain period described above. The pain and heat resolved approximately 84 hours after the injection. Tenderness and mild pain to the touch in the area under the armpit of the same arm where the vaccine was injected. This tenderness and mild pain started approximately six days after injection. This has not resolved yet.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PHM,"MVI, Omega-3, Magnesium, Zinc, Celebrex",None,None,,None,"['Axillary pain', 'Injection site pain', 'Injection site warmth', 'Tenderness']",1,MODERNA,IM 922224,CA,46.0,F,"Moderna COVID-19 Vaccine EUA, Adverse effect: Soreness at injection site on next day after injection. Soreness went away in 1 day. Then Dollar size raised hive at injection site, itchy, reddened- 1 week and 1/2 after injection administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,01/03/2021,8.0,PUB,Levothyroxine,None,None,,NKDA,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria']",1,MODERNA,IM 922225,IA,28.0,F,"Moderna COVID-19 EUA Mild lower back muscle pain began around 12 pm on 1/4/2021. Symptoms of headache, severe body aches, chills, nausea, shortness of breath, chest pain lasting 5 hours began around 7 pm on 1/4/2021. Headache and muscle pain remains present 36 hours after receiving vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,UNK,Birth control,None,None,,None,"['Chest pain', 'Chills', 'Dyspnoea', 'Headache', 'Myalgia', 'Nausea', 'Pain']",1,MODERNA,SYR 922226,MD,51.0,F,"Pain at injection site with increased pain around the deltoid region starting 12 hours after injection and lasting for 36 hours. The deltoid was hot to the touch and throbbing during the increased pain period described above. The pain, heat and throbbing resolved approximately 96 hours after the injection. Tenderness and moderate pain to the touch in the area under the armpit of the same arm where the vaccine was injected. This tenderness and mild pain started approximately five days after injection. This has not resolved yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PHM,"MVI, Zinc, Magnesium, Probiotic, Omega-3",None,None,,None,"['Axillary pain', 'Injection site pain', 'Injection site warmth', 'Pain', 'Tenderness']",1,MODERNA,IM 922227,OH,59.0,F,"Raised, egg-sized, itchy area that appeared several hours after the injection and is still present 8 days later. Will contact family physician if still present on 9th day. Arm painful to the touch and upon movement for 2 days. Headache, achiness also for 2 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,WRK,,,,"MMR in 2007--hives, SOB, Influenza in ??--SOB, flu-like symptoms",,"['Headache', 'Pain', 'Pruritus', 'Swelling', 'Tenderness']",1,MODERNA,IM 922229,CA,48.0,F,"arm pain x 3 days, diarrhea x 1 day, increased urination x 1 day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/05/2021,5.0,UNK,"Humira, methotrexate, folic acid",,rheumatoid arthritis,,none,"['Diarrhoea', 'Pain in extremity', 'Pollakiuria']",1,MODERNA,IM 922230,WA,20.0,M,Tiredness pain at injection site slight cough,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/01/2021,01/05/2021,4.0,MIL,None,None,None,,None,"['Cough', 'Fatigue', 'Injection site pain']",UNK,MODERNA,SYR 922231,TX,22.0,F,First day 10 mins after injection my left ear popped then at 10PM I started to feel body aches and had a low grade fever of 99.8 at 10:09PM. At 10:28PM my temperature went up to 101.5. Took Tylenol and fell asleep woke up at 3AM fever of 102.3 . Fell asleep and woke up again with a fever of 102.6. I had chills nausea weakness body aches headache. Took Tylenol again and fell asleep only to wake up again at 6:30Am still with a fever of 102. Nothing was making it go away I had no appetite extremely fatigued and nauseous it felt like I had covid again. I also felt swollen lymph nodes under my arm. By Sunday I was feeling way better and my fever was gone. Monday my ear popped again lasting a minute that?s never happened before. Monday today 01-05 still having headaches and now chest pain. I felt so bad I wanted to go to the hospital but did not it really did feel like I had covid all over again I would not want to put my self through that again. Also I did have covid back in October I believe just wanted to put that out there.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,None,None,None,,None,"['Asthenia', 'Chest pain', 'Chills', 'Decreased appetite', 'Ear discomfort', 'Fatigue', 'Feeling abnormal', 'Headache', 'Lymphadenopathy', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,SYR 922232,VA,27.0,F,"Approximately 10 minutes after the Moderna vaccination was administered, patient shared that her throat was feeling itchy. She was given 2 x 25 mg capsules of diphenhydramine and took them immediately. She was monitored for approximately 45 minutes post dose. During that period of time she noted that the itchy feeling in her throat resolved. She was advised to continue to monitor for symptoms, to repeat the dose of diphenhydramine if symptoms returned and to seek medical advice immediately.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,unknown,none,unknown,,unknown,['Throat irritation'],1,MODERNA,IM 922233,WA,63.0,F,Fever of 99.7 on 12/30/2020 Fever of 100.3 on 12/31/2020 Debilitating headache Chills,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PUB,Ventolin inhaler D-Mannose plus cranberry,,Asthma Obesity Nosebleeds,,Clindomyecin,"['Chills', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH,IM 922234,NJ,63.0,F,Rash in antecubital and hand of same arm the vaccine was given in.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,,['Rash'],1,PFIZER\BIONTECH,IM 922235,CT,27.0,F,"Rapid heart rate ten minutes after administration, anxiety attack and a hot face. Lasted 25 minutes in total.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,None,No,"Asthma, complex migraines, depression and anxiety",,"Bee stings, tamiflu","['Anxiety', 'Feeling hot', 'Heart rate increased']",1,PFIZER\BIONTECH,SYR 922236,TX,32.0,F,"Nausea, dizziness, felling of going to pass out, sweaty, fever, chills, body aches, crawling under skin tingling, swelling on lymph nodes especially underarm of injected arm, fatigue, muscles weak, moving slow, everything lasted about 3-5 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Omeprazole, Paxil, vyvanse, dayvigo, vitamin D 3, Xanax, multivitamin, procardia, metoprolol, Wellbutrin, zyrtec",None,"Covid-19, depression, anxiety, htn, asthma,",,Eugenol,"['Bradykinesia', 'Chills', 'Dizziness', 'Fatigue', 'Formication', 'Hyperhidrosis', 'Lymphadenopathy', 'Muscular weakness', 'Nausea', 'Pain', 'Paraesthesia', 'Pyrexia']",1,MODERNA,IM 922237,OR,38.0,F,"The right deltoid (injection site) was painful and tender for two days. Today, 8 days after receiving injection, the right deltoid began itching and there is a small area of urticaria at the injection site. No other symptoms today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,B complex once weekly; pharmacy brand flonase nasal spray daily,none,"environmental allergies (dust, grass, cats)",,Neosporin gives a rash,"['Injection site pain', 'Injection site pruritus', 'Injection site urticaria']",1,MODERNA,IM 922239,PA,43.0,M,"Patient reported after the 15 min observation that he felt dizzy, light headed and nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,,N/a,N/a,,,"['Dizziness', 'Nausea']",1,PFIZER\BIONTECH,IM 922240,MT,82.0,F,"Patient vomited one time, 1 hour after administration, observed by nursing staff, Patient had no other complaints or signs prior to vomiting, patient monitored for additional 15 minutes, and did not develop any other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,Information not available,uncertain,Diabetes,,No known allergies to medication,['Vomiting'],1,PFIZER\BIONTECH,IM 922241,OH,57.0,M,Severe arms shoulder and hand pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,PVT,"Protonix,HCTZ,losartan,gabapentin,alpha poitininvokana,trulicity",Brochitis,Neuropathy feet,,Lisinopri,"['Arthralgia', 'Pain in extremity']",1,MODERNA,IM 922242,MI,62.0,F,Patient reported wide spread itching all over body 15 minutes after vaccination. State that she had a history of this type of reaction at least once a year and it is usually relieved by Benadryl. Was given 50 mg of Benadryl and symptoms resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,,,,,,['Pruritus'],UNK,MODERNA, 922243,MN,36.0,F,Developed a baseball size red area at insertion site 13 days after receiving injection. It is not raised or sore. It is hot to touch. Does not itch. No treatment has been completed at this time.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,01/05/2021,13.0,WRK,Tamoxifen Duloxetine Vitamin D Diclofenac,,History of breast cancer with chemo and radiation,,MRI contrast,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA,IM 922244,NJ,53.0,F,Numbness and tingling in fingers and hand of same arm the vaccine was given in.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 922245,GA,57.0,F,"per patient ""I took the Moderna vaccine yesterday morning. By mid morning i had a few red blotches on my face, some itching on my extremities and tingling in my lower lip. I stopped back past the vacccine area this morning to let them know i had a very small reaction and i was told to complete an injury report.""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,,,,,,"['Erythema', 'Paraesthesia oral', 'Pruritus', 'Rash macular']",UNK,MODERNA,IM 922246,AR,46.0,M,Delayed onset Hives associated with dizziness. They lasted approximately 20 Minutes,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/24/2020,6.0,PHM,None,Gastroenteritis 2 weeks before,None,,Sulfa,"['Dizziness', 'Urticaria']",1,PFIZER\BIONTECH,IM 922247,NJ,59.0,F,"slight itchiness, hot to touch, and half dollar size pink welt at injection site 9 days after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/05/2021,9.0,UNK,"olmasartan, 81 mg aspirin, hydochlorothiazide, pantoprozole, vitamin D",,high blood pressure (controlled),,"sulfa,gluten sensitive","['Injection site reaction', 'Pruritus', 'Skin warm', 'Urticaria']",1,MODERNA,SYR 922248,LA,38.0,F,?Moderna COVID-19 Vaccine EUA? Localized raised bumps with itch at injection site. Self-report as minor and no additional symptoms. Took 25mg OTC benedryl by mouth at advice of medical provider.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,OTH,"multi vitamin, calcium citrate, calcium carbonate.",none.,none.,,penicillin (hives in infancy),"['Injection site pruritus', 'Injection site rash', 'Rash', 'Rash papular']",1,MODERNA,IM 922249,MI,41.0,F,Axillary pain with swelling of lymph nodes in axillary are of left arm and up into neck.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/04/2021,4.0,WRK,"Ibuprofen, Tylenol, Calcium with D3",None,None,,Effexor and Bactrim,"['Axillary pain', 'Lymphadenopathy']",1,MODERNA,IM 922250,OR,30.0,F,"returned to clinic site with her manager stating that she felt yucky, little nauseated. No hives, no tingling, no numbness, no abdominal pain, no SOB, no chest or throat tightness. Sent Home. Called back and stated got dizzy so husband picked her up and took her to ER, they gave her a note and now she is home.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,unknown,unknown,unknown,,unknown,"['Dizziness', 'Feeling abnormal', 'Nausea']",1,MODERNA,IM 922251,MI,78.0,F,Patient reported blurry vision shortly after vaccination while being monitored. No other side effects reported. Patient was monitored until symptoms eventually resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,SEN,,,,,,['Vision blurred'],UNK,MODERNA, 922252,NJ,29.0,F,Pain and tenderness at the injection site longer than 24 hours post injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,No,No,No,,No,['Injection site pain'],1,MODERNA,IM 922253,NY,41.0,F,"Original soreness at injection site lasted 2 days and resolved. On day 7, the shoulder (not arm) became tender with blanching erythema. Currently self-monitoring distribution of erythema at home with marked boundaries on skin.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,Blissova,None,None,,None,"['Erythema', 'Injection site pain', 'Pallor', 'Tenderness']",1,MODERNA,IM 922254,NY,40.0,F,"DIZZINESS, CHEST TIGHTNESS, ANXIETY",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,none,none,asthma,,none,"['Anxiety', 'Chest discomfort', 'Dizziness']",UNK,MODERNA, 922255,PA,33.0,M,"Weakness, dizziness, lightheaded, cramps, chest pain, shortness of breath, headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,PVT,Albuterol,,Asthma,,KNDA,"['Asthenia', 'Chest pain', 'Dizziness', 'Dyspnoea', 'Headache', 'Muscle spasms']",1,PFIZER\BIONTECH,IM 922257,AK,61.0,M,"patient was given dose to of Pfizer vaccine early (dose 1 was given 12/21/2020), patient was seen at a vaccine clinic offsite and had checked no to question of ""have you received any vaccinations within the last 2 weeks?""",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,PUB,,,,,,['Inappropriate schedule of product administration'],2,PFIZER\BIONTECH,IM 922258,OH,46.0,M,"Severe headache, profuse vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Full blood count abnormal', 'Headache', 'Immature granulocyte percentage increased', 'Leukocytosis', 'Vomiting', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 922259,CA,33.0,F,Pain and swelling under armpit of left arm. As of 1/5/21 (day 7) pain and swelling continues.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,WRK,none,none,none,,none,"['Axillary pain', 'Oedema peripheral']",1,MODERNA,IM 922260,NE,28.0,F,"Injection site reaction had resolved. One week after the vaccine my injection site reaction returned with itching, swelling, redness as a firm bump in an odd shape around the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/05/2021,7.0,UNK,,,,,,"['Injection site induration', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA, 922261,NY,53.0,M,"Profuse sweating (20 mins after injection), headache ( like migraine), muscle soreness in left arm, balance off, soreness at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Losartan/Hydrochlorothiazide, Plavix, Tylenol, Asprin 81 mg, Famotidine",None,"Double by pass surgery (2x CABG), tent Placement in one graft in Heart, High Blood Pressure and Cholesterol.",,None,"['Balance disorder', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Myalgia']",1,PFIZER\BIONTECH,IM 922262,CA,31.0,F,"Red, hard,swollen, hot to touch",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,UNK,not applicable,none,none,,none,"['Erythema', 'Induration', 'Skin warm', 'Swelling']",1,MODERNA,SYR 922263,CA,47.0,F,"After vaccination I had light headedness from time of vaccination to 3 hours later. There was some mild itching at the site for 30 minutes after injection. From half hour after vaccination to 3.5 hours later I had a very mild headache. Starting at 8 pm, 9 hours after vaccination, I had muscle soreness at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,Copaxone Vitamin D 1000 mg,,Multiple Sclerosis,,No,"['Dizziness', 'Headache', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,IM 922264,CA,31.0,M,"Immediate warm rush to my head and body. Heart was beating out of my chest and difficultly breathing. Heart rate spiked to 150 (normal around 55). Hand, legs, and mouth started to go numb. Eventually settled down after about 1 hr. Have not felt normal since which has been 3 days.",Not Reported,,Yes,Not Reported,,Not Reported,U,,,,PVT,None,None,None,,None,"['Dyspnoea', 'Feeling abnormal', 'Feeling hot', 'Heart rate increased', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Immediate post-injection reaction', 'Palpitations']",1,MODERNA,SYR 922265,CA,53.0,F,"Took vaccine on 12/23/20 no major symptoms, next injection site soreness w/ slight pain. On 1/4/21 had vomited/ major headache at 3:44am. Continued feeling sick nauseous mild headache brought My blood to be high all day. On 1/5/20 woke up with headache and diarrhea (6 times for the past13hrs) discomfort of the stomach. Hardly no appetite. Also noticed today my injection site left arm (slight red and rise bumps almost like a big rash or welts and itchy. That?s what caught my attention to see my arm. My concern is could this be part of late reaction of the vaccine?",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/04/2021,12.0,PVT,None,None,Diabetes/ hypertension,,None,"['Abdominal discomfort', 'Decreased appetite', 'Diarrhoea', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site reaction', 'Malaise', 'Nausea', 'Urticaria', 'Vomiting']",1,MODERNA,SYR 922266,IL,40.0,M,"At about 1330 on 30DEC, the patient received the 1st dose of the Moderna COVID-19 vaccine. Less than five minutes after the vaccine was administered, the patient noticed a metallic taste. About two to three minutes afterwards, the patient noticed a ?tingling? sensation mostly on the left side of the face and minimally on the right side. Almost immediately after the ?tingling? sensation, the patient felt the sensation of an increased heart rate and checked his pulse with his watch that had a pulse sensor. The watch indicated that he had a heart rate of 115 bpm. This sensation of an increased heart rate subsided after for one or two minutes and repeat pulse measurement was in the low 90s. Towards the end of the 15 minute post-vaccination observation period, the medical technician did the final check on the patient. The patient admitted to experiencing a metallic taste and a mild tingling sensation on the neck and face area. The service member was immediately brought back to the treatment room were a faint red rash and was noticed on the left side of the neck by the medical providers present. Two doses of Benadryl 25mg were given and the patient was told to continue to be observed in the observation area. After about 20 minutes, the tingling sensation resolved. The patient checked his pulse again and it was in the low 70s. The metallic taste resolved after about one and a half hours after the start of the symptom.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,MIL,None,None,None,"Metallic taste with one vaccine in the past, unknown vaccine type, unknown date,. Lasted a few minutes and resolved spontaneous","No known drug allergies Possible seafood allergy, not formally diagnosed. Manifested as tingling, itchiness, rash.","['Dysgeusia', 'Heart rate increased', 'Paraesthesia', 'Rash', 'Rash erythematous']",1,MODERNA,IM 922267,AZ,52.0,F,Woke up at 3:30 am due to ringing in my left ear. Ringing has continued all day.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,Telmisattan 40 mg daily Omeprazole 40 mg daily Centrum Women 50+,None,Hypertension,,Sulfa,['Tinnitus'],1,PFIZER\BIONTECH,IM 922268,TX,30.0,F,Injection site reaction/swelling/redness/pain/warmth to touch - ongoing abdominal cramping - ongoing febrile - ongoing muscle/joint aches - ongoing tachycardia - ongoing headache - ongoing,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PUB,Spironolactone 50 mg daily Amitriptyline 25 mg daily Beyaz daily Zyrtec 10 mg daily Cyclobenzaprine 10 mg daily,None,Migraines PCOS,,PCN,"['Abdominal pain', 'Arthralgia', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Myalgia', 'Pyrexia', 'Tachycardia']",1,MODERNA,IM 922269,FL,52.0,F,"Unusual pain with injection. By evening was very sore and had to take medication during the night. Next day I was unable to take off my sports bra without assistance due to pain. Pain has persisted over 2 months. Severity waxes and wanes but it?s always present, esp with exercise.",Not Reported,,Not Reported,Not Reported,,Yes,N,11/01/2020,11/09/2020,8.0,PVT,Losarten HRT patch,None,"Low back and hip pain, piriformis syndrome controlled with PT and home exercise.",,Bactrim,"['Injection site pain', 'Loss of personal independence in daily activities', 'Pain']",1,PROTEIN SCIENCES CORPORATION, 922270,TX,57.0,F,"Approximately 30 minutes after receiving the Moderna vaccine in my left arm, my entire left arm, face and part of my neck felt very tingly, tight, and slightly warm for about an hour. My cheeks were also slightly puffy. The intensity decreased after about an hour from the onset of the effects (1.5 hours after the vaccine.) After 24 hours my face still feels tingly and tight, but only slightly compared to the day of the vaccine. I also have have waves of feeling nauseous about 30 minutes after receiving the vaccine and it continues after 24 hours after receiving the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,Metrogel (for acne rosacea) Muro 128 2% eye drops to treat Fuch's Dystrophy Muro 128 5% ointment (night time use for Fuch's Dystrophy) Systane eye drops for dry eye,None,Acne Rosacea,,Advair diskus inhaler Noxema,"['Muscle tightness', 'Paraesthesia', 'Skin swelling', 'Skin warm']",1,MODERNA,IM 922271,NV,25.0,F,"At 3am the next morning I woke up and felt nauseous. I felt like I had a fever and the aches. At 6 am I started throwing up and heaving for hours. Later in the day I took my temperature and had a fever of 101, my fever later broke after taking Tylenol and NyQuil. The next day, Saturday, my lymph node in the left armpit was so swollen I could not wear a shirt. My nausea continued but I no longer had a fever. My lymph node continued to be swollen until Monday. On Monday I woke up with a rash on the left side of my chest, small red dots and this resolved by the end of the day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,WRK,Xulane,"Possible covid infection, tested negative but roommate tested positive",,,Septra,"['Feeling abnormal', 'Lymphadenopathy', 'Nausea', 'Pyrexia', 'Rash', 'Rash erythematous', 'Retching', 'Vomiting']",1,MODERNA,SYR 922272,NE,71.0,F,"Had a sore arm for about 36 hours, no problems. Then one week later the arm got itchy and a mild raised red rash has developed. Continues to itch and have increasing rash on day 8.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,PUB,"Lexapro, pravastatin, montlukast,",None,None,,"Amoxicliin, zithromax, keflex, adhesive, betadine","['Pain in extremity', 'Pruritus', 'Rash', 'Rash erythematous', 'Rash papular']",1,MODERNA,IM 922273,MS,39.0,F,"12 days out from vaccine, re-local reaction with itching and erythema and raised about 4 inch large at injection site. No pain, on day 13 with brusing in the center as well and itching. Fatigue worse both of these days, no fever. Benadryl oral taken and helped itching, but did not change the size or erythema of rash at local injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,01/04/2021,12.0,PVT,metoprolol trintellix turosimide pottasium metformin ozempic cornolor librax excerdrin migraine motrin zofran,none,diabetes HTN tachycardia anxiety migraines,,none,"['Fatigue', 'Injection site bruising', 'Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Local reaction', 'Rash erythematous']",1,MODERNA,IM 922274,AK,44.0,F,The vaccine was administered at 11:37am. The patient experienced sweating starting at 11:54am. Sweating slowed around 12:03pm. 50 mg of oral diphenhydramine was administered at 12:15pm. Symptoms resolved and the patient left at 12:28pm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PHM,None,None,None,,None,['Hyperhidrosis'],1,MODERNA,IM 922275,NH,52.0,F,Experience chills during wait period about an hour and a half pain in arm increased numbness and the mobility of. Right arm was difficult to move. employee health applif ice my pain was at a ten level down to a 7 when. I was rent home. I made appt whth doctor for 1/6/21,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,WRK,Vyvanse,0,urticaria,,Naproxen jalepenos,"['Chills', 'Hypoaesthesia', 'Mobility decreased', 'Pain in extremity']",1,MODERNA,SYR 922276,OR,41.0,F,"1845 PATIENT REPORTS HEART PALPITATIONS, FLUSHED FACE, FEELING WARM, ICE PACK TO NECK, FEELING NAUSEATED. 1848 BP 161/114 HR 112. 1852 BP 148/91 HR 92 PATIENT RESTING. 1900-1910 PATIENT FEELS LIKE SHES ""HAVING A DRY THROAT, ""A LITTLE SHORT OF BREATH, AND TIGHT IN CHEST."" BP 144/95 HR 84 SAO2 99%. ICE PACK TO NECK. PT OFFERED H20 AND JUICE. RELAXING WITH EYES CLOSED.1920-1928 BP156/97 100% PATIENT FEELING ANXIOUS. DEEP BREATHING. 1938-1949 PATIENT MOVED TO QUIET AREA UNDER OBSERVATION. BP 138/93 HR 81 SAO2 99%, FEELING BETTER, NO NAUSEA, SCRATCHY THROAT IMPROVING, DENIES SEVERE ANXIETY. 1959 PATIENT FEELING BETTER, NO RASH, THROAT TIGHTNESS OR ANXIETY, VSS, CHEST TIGHT BUT BETTER, PATIENT REPORTS SIMILIAR TO BASELINE. PATIENT STABLE WANTING TO GO HOME. AWARE OF NEEDING TO SEEK MEDICAL CARE THROUGH ER OR HER PROVIDER IF SYMPTOMS WORSEN.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Anxiety', 'Chest discomfort', 'Dry throat', 'Dyspnoea', 'Feeling hot', 'Flushing', 'Nausea', 'Palpitations', 'Throat irritation']",1,MODERNA,IM 922277,TX,29.0,F,"Jan 05, 2021 : Dr.: Established Patient Video Consult :Video Consult Search Notes EditExportPrintReportsFaxRx1 of 1 Age29Visit TypeEstablished Patient Video Consult DateJan 05, 2021StatusUnsignedProviderDr. Signed by-- Subjective Chief Complaints Pfizer vaccine last Tuesday on Left arm.. 1.5 days later on opposite arm around elbow. Chief Complaint Rash History of Present Illness Location of symptoms: Generalized body, Chest, Abdomen, Upper Extremities, Right, Left Timing: Worsening on prednisone and famotidine oral treatment",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/31/2020,2.0,UNK,none,none,none,,none,['Rash'],1,PFIZER\BIONTECH,IM 922278,,43.0,F,"1 hour post vaccine, started extreme fatigue and nodding off/sleeping which lasted 4 hours. Experienced chills 3 hours post vaccine which lasted 1 hour. The treatments I used were rest and warming myself.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,SEN,None,None,None,,None,"['Chills', 'Fatigue', 'Somnolence']",1,PFIZER\BIONTECH,IM 922279,CA,40.0,F,"Patient presented to receive COVID-19 vaccine, received vaccine at approximately 10 am. Patient waited 15 minutes for observation and left observation area without complaining of any sx. Patient returned a few minutes after reporting tongue tingling which eventually got to her lips. . No difficulty breathing or any other sx. No history of allergies. NP/RN administered PO Benadryl 25 mg. As of report of this iReport no additional symptoms or intervention needed. Last vitals: 131/83 75spo2. BP higher than usual per patient, sp02 normal.",Not Reported,,Yes,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,UNK,,,,,,"['Blood pressure increased', 'Paraesthesia oral']",1,MODERNA,IM 922280,OR,38.0,F,"A week after the vaccine, my smallpox vaccine scar started getting red and inflamed. It was on the same side as the vaccine but not really near the shot. I had the smallpox vaccine as a child in the early 1980s when I was a kid. Have never had this problem before with any other vaccine. Now, a week after this reaction started the redness has mostly subsided but not completely.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/28/2020,6.0,PVT,Felodipine 2.5 mg daily.,None,Hypertension,,None,"['Erythema', 'Skin lesion inflammation']",1,MODERNA,IM 922281,AZ,48.0,F,I have preexisting chronic neck pain that prior to the vaccine rated 0-2 on a daily basis. A MRI was obtained in approx 2015 that showed encroachment in the cervical spine. Since the day after the 1 dose the pain daily has rated from 2-5 and has been persistent.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/15/2020,12/16/2020,1.0,PVT,"Estrogel, Synthroid, Zyzal, Elderberry, Vit C, Zinc, Vit D, Tumeric, Burberine, Omegas, Collagen",none,"Chronic Neck Pain preexistent. Worsened the day after the 1st vaccine and persistent. Hypothyroid, obesity.",I previously had similar symptoms after receiving a flu vaccine in the past,none,"['Neck pain', 'Pain']",1,PFIZER\BIONTECH,IM 922282,CA,68.0,F,"tinglling, intermittat pain and intermittant weakkess L arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,11/12/2020,11/13/2020,1.0,PVT,"atorvastatin 10, lorazepam0.5, olmesartan 20, omeprazole 20, paroxetine 40",no,"depression,hypertension,gastroesophageal reflux,hyperlipidemia,knee sprain",,xantines strawberries,"['C-reactive protein', 'Muscular weakness', 'Pain', 'Paraesthesia', 'Red blood cell sedimentation rate']",1,"SEQIRUS, INC.",IM 922664,IL,63.0,F,"Approx. 5 hours after vaccine an arrhythmia began + lasted through next day. UpoN waking + standing, I experienced multiple near - syncopal episodes throughout the day. Arrhythmia continued with decreased blood pressure. No fever, vomiting or diarrhea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PUB,"Diltiazem, Flecanide, Warfarin, CiTALoPRAn",,A-fib. A-flutter,,,"['Arrhythmia', 'Blood pressure decreased', 'Syncope']",1,MODERNA,IM 922699,IN,54.0,F,"Within 72 hrs. of receiving the first dose of her Pfizer vaccine she developed sharp headache unlike any headaches that she has had in the past, located bilateral frontal and on top of her head. Not associated with photophobia, phonophobia, nausea, vomiting, or vision changes, but can be severe enough that she has to sit down",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/26/2020,3.0,PVT,"herbal supplements, atenolol 25mg, flecainide 100mg",none,,,"codeine, latex",['Headache'],UNK,PFIZER\BIONTECH, 922713,NE,74.0,M,"6:30am 12/31/20 pt c/o stiffness, dizziness, injectionsite pain, cough, runny ose, mental fog. Temp 100.1. Given 2 tylenol 500mg c/o chills and weakness and fatigue - continues through the day. 7:30 pm pt oriented to person and place but not time could not follow direction to check blood sugar extreme chills. Temp 102.3 called on call internist and was instructed to give 400 mg motrin with 2 tylenol fever roke at 9pm pt was lucid.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,"Covid Positive test Nov 27, 2020","Diabetic, Afib, high blood pressure, GERD, GOUT",,,"['Asthenia', 'Chills', 'Cough', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Injection site pain', 'Musculoskeletal stiffness', 'Pyrexia', 'Rhinorrhoea', 'Time perception altered']",1,MODERNA, 922725,PA,74.0,F,"Sat required 15 minutes on site. Left facility and shopping on way home with my husband, when checking out felt light headed, dizzy - if I would pass out. Once home ate something as had only small breakfast - symptoms passed. Gavie it no more thought until talking with a co-worker. She experienced same thing along with another co-worker",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,WRK,multivitamin - calcium/Vitamin D,No,No,,None known,['Dizziness'],1,PFIZER\BIONTECH,IM 922772,FL,50.0,F,"headache, right arm to leg sore, sweating dizzy, hot & cold, want to throw up, loss of appetite, some chest pain, feel woosy, felt confussed right after vaccine,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,SEN,"Linispril, omphrez, Ioprophen",None,,,sulfa,"['Chest pain', 'Confusional state', 'Decreased appetite', 'Dizziness', 'Feeling of body temperature change', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 922775,UT,48.0,M,I have had whole body myalgias since the first day of the vaccine. I am now 19 days since the vaccine and continue to feel them most of the day. They were the most intense the first weeks but have improved slightly since then. I also have had fatigue during this time period with occasional headaches. I have had lightheadedness for the past week.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/17/2020,0.0,PVT,"sertraline 50mg daily, famotidine 20mg daily, Flonase nasal",None,"GERD, seasonal allergies, PTSD",,None,"['Dizziness', 'Fatigue', 'Headache', 'Myalgia']",UNK,PFIZER\BIONTECH, 922776,PA,29.0,F,Vaccine received at 215pm on 12/30/20. Arm pain 8PM. Chills and aches at 10PM. Awoke at 115AM on 12/31/20 with heart rate of 150 beats per minute and chest pain persisting for 30+ minutes. Went to ER at 2AM. Heart rate recorded at ER was 124. Hydroxyzine and fluids given. Patient sent home from ER.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,,,,,,"['Blood test normal', 'Chest X-ray normal', 'Chest pain', 'Chills', 'Electrocardiogram normal', 'Heart rate increased', 'Pain', 'Pain in extremity']",1,MODERNA,IM 922785,TX,41.0,U,"About 5 minutes after vaccine was given, tingling sensation occurred on left arm down to left hand (Thumb, index, middle finger.) Grip is good both hands On 12/31/2020 Patient experienced ""Nickle sized welts on her elbow, wrist and stomach. She also experienced more tingling in her left arm. There was 2 welts on her left wrist and 1 welt on her left elbow. The welt on her stomach was on her right side. She took some Zyrtec and applied warm packs. The welts resembled an ""ant bite"", ""raise but no pus"" in them. As of today 1/5/2021, They are resolved and patient feels better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PUB,none,none,none,,Cipro (N/V),"['Paraesthesia', 'Urticaria']",1,MODERNA,IM 922786,NY,42.0,F,"Pt vaccinated at 8:40 Am. Pt reported feelings of warmth, dizziness, and lightheadness 5 minutes post vaccination. Pt assisted to stretcher, B/P 129/95 HR 65 RR 20 O2 Sat 99% RA. Pt hydrated with electrolytes/water. Pt reports prior episodes of same symptoms outside of vaccinations. Pt reported resolution of symptoms after prolonged monitoring. d/c'cd at 10:08 Am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Synthroid, Vitamins, Zyrtec, Tylenol, OCPS",None,Hypothyroidism,,None,"['Dizziness', 'Feeling hot']",1,MODERNA,IM 922787,WI,30.0,F,W/in 10 minutes of receiving vaccine of reported SOB Felt like she couldn't get enough air - removed mask - still SOB - took BP 110/72 @ 1045am- pt waited to make sure she was sure she was having a RxN before taking Benadryl. Took 50mg Benadryl @1115 D/C 1145 Feeling Normal,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2020,01/04/2021,366.0,SEN,None,None,None,,None,['Dyspnoea'],1,MODERNA,IM 922788,IL,69.0,F,"Fatigue, Headache, Chills, Nausea, joint pain began on Friday Jan. 1, 2021 symptoms started about 0800. All symptoms have continued through today Jan. 4, 2021. Taking tylenol 500mg for headache Symptoms lasted for 4 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,meloxicam 15 mg melatonin 10 mg Tizanidine 4 mg Montalukast 10mg Levothyrox TB 75 mcg multivit,Pain in Lt. gluteus muscle,,,Sulfa,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Nausea']",1,MODERNA,IM 922970,MN,55.0,M,"Myalgia, Fever, NauseaVomiting & HYPERtension",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Hypertension', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",UNK,MODERNA, 922972,MN,76.0,M,ErythemaMultiform,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/25/2020,3.0,OTH,,,,,,['Erythema multiforme'],UNK,MODERNA, 922975,PA,89.0,M,Pt is being treated for suspected pneumonia with antibiotics Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Blood creatinine increased', 'Blood glucose increased', 'Blood urea increased', 'Brain natriuretic peptide increased', 'Hypermagnesaemia', 'Hypocalcaemia', 'Hypokalaemia', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Pneumonia', 'Pyrexia', 'Respiratory syncytial virus test negative', 'SARS-CoV-2 test negative', 'White blood cell count increased']",2,MODERNA, 922976,NY,74.0,M,"Fever 100.4 on 12/22/20 13:33 and vomited x 1 on 12/22/20 s/p COVID-19 vaccine received on 12/21/20 @ 15:22. Acetaminophen 650mg administered 12/22/20 @ 17:44 with resolution of symptoms w/in 1-2 days; Vancomycin 1 gm once and Ceftazidime 2gm once post dialysis also given empirically. Fever & NauseaVomiting. ACETAMINOPHEN 650 MG ONCE, VANCOMYCIN 1 GM ONCE POST DIALYSIS ,CEFTAZIDIME 2 GM ONCE POST DIALYSIS",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/22/2020,1.0,OTH,,,,,,"['Nausea', 'Pyrexia', 'Vomiting']",2,MODERNA, 922977,NY,71.0,M,"Fever, RespDepression & COVID positive REMDESIVIR (EUA) 200 mg x1 then 100 mg daily",Yes,12/28/2020,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/27/2020,6.0,OTH,,,,,,"['Pyrexia', 'Respiratory depression', 'SARS-CoV-2 test positive']",2,MODERNA, 922978,NY,71.0,M,Slightly below low grade fever at 99.2F on 12/23/20 @ 1:15 s/p COVID-19 vaccine received on 12/21/20 @ 14:43. Acetaminophen 650mg administered once on 12/23/20 @1:15 with resolution of symptoms by morning 12/23/20 @ 7:30. Fever ACETAMINOPHEN 650 MG ONCE,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/23/2020,2.0,OTH,,,,,,['Pyrexia'],2,MODERNA, 923145,LA,62.0,M,"Rapid response called at 16:47, Care escalated to ED. Dizziness, Headache, Rash & diaphoresis",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/16/2020,12/16/2020,0.0,OTH,,,,,,"['Dizziness', 'Headache', 'Hyperhidrosis', 'Rash']",2,PFIZER\BIONTECH, 923148,,76.0,M,Fever & fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/26/2020,4.0,OTH,,,,,,"['Fatigue', 'Pyrexia']",2,MODERNA, 923150,NY,58.0,M,Fever 100.1F on 12/30/20 13:20 s/p COVID-19 vaccine received on 12/28 @13:03. Acetaminophen 650mg oral liquid administered 12/30 13:30 and 18:42 with resolution of fever. Patient experienced fever 100.1F again on 12/31 @11:31 and refused Acetaminophen; fevers also may be attributed to patient's current abscess/cellulitis Fever & 100.1F ACETAMINOPHEN 650 MG ONCE X 2,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Abscess', 'Cellulitis', 'Pyrexia']",2,MODERNA, 923206,,91.0,M,& injection site redness,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/24/2020,2.0,OTH,,,,,,['Injection site erythema'],2,MODERNA, 923533,NY,77.0,M,Fever 99.6F on 12/29/20 @22:41 and on 12/31/20 @03:52 s/p COVID-19 vaccine received on 12/28/20 @13:39. Patient is on standing Acetaminophen 650mg q6h for pain/fever. Acetaminophen 650mg administered 12:29 @22:41 and 12/31 @06:02 with resolution of symptoms. Fever ACETAMINOPHEN 650 MG QID FOR PAIN/FEVER,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Pain', 'Pyrexia']",2,MODERNA, 923534,SD,65.0,F,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/29/2020,1.0,OTH,,,,,,['Myalgia'],2,MODERNA, 923535,,89.0,F,Diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/29/2020,7.0,OTH,,,,,,['Diarrhoea'],2,MODERNA, 923536,,42.0,M,Headache & Rash DIPHENHYDRAMINE 50 MG QID,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Headache', 'Rash']",2,MODERNA, 923537,,73.0,M,Headache & FACIAL FLUSHING,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Flushing', 'Headache']",2,MODERNA, 923538,MN,93.0,M,"Myalgia, Fever & ErythemaMultiform",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Erythema multiforme', 'Myalgia', 'Pyrexia']",2,MODERNA, 923539,NY,85.0,M,Low grade fever 99.2 on 12/29/20 09:23 s/p COVID-19 vaccine received on 12/28 @13:05. Acetaminophen 650mg oral liquid administered 12/29 05:11 and 13:56 with resolution of fever (patient on standing q8h order for pain/fever) Fever & 99.2F ACETAMINOPHEN 650 MG TID VIA PEG,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/29/2020,1.0,OTH,,,,,,['Pyrexia'],2,MODERNA, 923540,,46.0,F,"Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her own albuterol inhaler without relief. Transported to ED. PE: red hands with swelling, throat and lip swelling with difficulty swallowing. Later developed headache and dizziness then tachypnea and stridor. Meds given - See section 5 PLUS epinephrine IM and infusion @ 0.05 mcg/kg/min, Alb and ipratropium negs, racemic epi nebs. Admitted to the hospital on 12/22 and still hospitalized at the time of this report on 12/23. She remains on an epinephrine drip and was given methylprednisolone 125 mg IV x 2. No previous history of anaphylaxis. History of Reye's syndrome as a child when given aspirin.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Anaphylactic reaction', 'Dizziness', 'Dysphagia', 'Dyspnoea', 'Erythema', 'Headache', 'Lip swelling', 'Peripheral swelling', 'Pharyngeal swelling', 'Stridor', 'Tachypnoea']",UNK,PFIZER\BIONTECH,IM 923543,,48.0,F,"Tachypnea throat tightness, short of breath, concern for anaphylaxis Narrative: Present to ED five days after vaccine w/c/o tightness in throat and shortness of breath; treated in the ED w/epinephrine, benadryl, famotidine and methylprednisolone and observed for two hours; prescribed Epi-pen for take-home. Discharged home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/28/2020,5.0,OTH,,,,"yes; bees, wax floor care; some allergy shots",,"['Dyspnoea', 'Tachypnoea', 'Throat tightness']",1,MODERNA,IM 923545,,79.0,M,Fever & SkinRash,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/25/2020,3.0,OTH,,,,,,"['Pyrexia', 'Rash']",2,MODERNA, 923546,,53.0,F,"Dizzy, altered, stridor. No oral swelling observed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Dizziness', 'Mood altered', 'Stridor']",1,PFIZER\BIONTECH,IM 923547,NE,66.0,F,"66 you female who presented to to infusion clinic for lung cancer treatment. Pt received apap 650mg po, diphenhydramine 50mg PO at 1000. She also was administered NaCL 0.9% as a carrier for durvalumab as an infusion between 1000-1200. Pt was administered COVID19 vaccine at 1110. At 1120 patient called out stating ""I just don't feel right"". Pt was diaphoretic/weak/hypotensive. No swelling or respiratory distress noted during the episode. Attending physician and PharmD alerted and were at bedside. Per note, pt has needle phobia. Please refer to relevant history below for information regarding BP. Patient was monitored closely at the infusion clinic. She was able to receive her chemo agent as planned after she felt better from eating. Patient does not wish to get the second dose of covid vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Alanine aminotransferase normal', 'Albumin globulin ratio', 'Amylase normal', 'Anion gap', 'Aspartate aminotransferase normal', 'Asthenia', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bilirubin normal', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine normal', 'Blood glucose normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea increased', 'Carbon dioxide normal', 'Feeling abnormal', 'Glomerular filtration rate decreased', 'Hyperhidrosis', 'Hypotension', 'Lipase normal', 'Protein total normal']",UNK,PFIZER\BIONTECH, 923548,PA,90.0,M,"Fever, NauseaVomiting & chills, abdominal pain",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Abdominal pain', 'Aspartate aminotransferase increased', 'Blood alkaline phosphatase increased', 'Blood bilirubin increased', 'Blood magnesium normal', 'Chills', 'Differential white blood cell count', 'Full blood count', 'Liver function test increased', 'Nausea', 'Protein total decreased', 'Pyrexia', 'Vomiting', 'White blood cell count increased']",2,MODERNA, 923550,NY,65.0,M,Low grade temp 99 F on 12/30/20 1:12 s/p COVID-19 vaccine [Moderna] received on 12/28 @13:08. Acetaminophen 650mg administered once on 12/30 2:09 with resolution of symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/30/2020,2.0,OTH,,,,,,['Pyrexia'],2,MODERNA, 923551,NY,89.0,M,"89 y/o M with PHM of HTN, CAD, cardiomyopathy, HFrEF (EF 30%), Right Lobe thyroid nodule / L lobe cyst (declined biopsy), subclinical Hyperthyroidism, A fib, TIA, remote h/o PUD (bleeding ulcer s/p pyloroplasty and vagotomy 1999), internal hemorrhoids, spinal stenosis of lumbar region, HLD, asbestosis, BPH, anemia, goiter, osteoporosis, vitamin D deficiency, who underwent Right Hip Intertrochanteric ORIF on 6/11/20 s/p R hip fracture on 5/28/20 and was admitted to nursing home for SAR on 6/25/20.Patient reported weakness and loss of appetite on 12/29/20 18:36 s/p COVID- 19 vaccine received on 12/28 @13:09. Patient is being monitored.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Asthenia', 'Decreased appetite']",2,MODERNA, 923554,,55.0,F,"Agitation, Sedation, Anaphylaxis, Rash & HYPOtension",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,,12/23/2020,,OTH,,,,,,"['Agitation', 'Anaphylactic reaction', 'Hypotension', 'Rash', 'Sedation']",1,PFIZER\BIONTECH,IM 923555,,38.0,F,"Anaphylaxis Patient was vaccinated and within just a few minutes of vaccine administration began to feel throat tightening, difficultly getting air, tachycardia, and dry mouth. Admitted to a past history of anaphylaxis with shell fish and endorses similar symptoms. Employee was treated with an epi pen and taken to the emergency room for additional monitoring and treatment as needed",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Anaphylactic reaction', 'Dry mouth', 'Dyspnoea', 'Tachycardia', 'Throat tightness']",1,PFIZER\BIONTECH,IM 923556,,51.0,F,"Headache, Anaphylaxis, UrticariaPruritus & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Anaphylactic reaction', 'Headache', 'Nausea', 'Pruritus', 'Urticaria', 'Vomiting']",3,PFIZER\BIONTECH,IM 923557,,69.0,M,"Anaphylaxis throat itchiness, throat tightness, sinus swelling, ear fullness Narrative: Patient reported throat itchiness, throat tightness, sinus swelling, ear fullness. Transported via EMS to nearest ER",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Anaphylactic reaction', 'Ear discomfort', 'Nasal congestion', 'Throat irritation', 'Throat tightness']",1,PFIZER\BIONTECH,IM 923558,MT,,F,"Right arm swelling, golf ballsized on 12/31/2020. Redness, tenderness. By 1/1/21 swelling increased to entre arm, red, not to the touch. By 1/3/21 swelling was gone, redness still there, no pain. Muscle tenderness to the right arm still present",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/31/2020,7.0,WRK,Orthocycline-Birthcontrol,,,,,"['Erythema', 'Myalgia', 'Peripheral swelling', 'Skin warm']",1,MODERNA,IM 923559,MT,39.0,M,"12 hours after vaccine: Fever 104�F Day 2: 103� fever, no energy, body aches, chills, headache, swollen lymph node, pain in left armpit, sweats, slept all weekend.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,PVT,,,,,None,"['Asthenia', 'Axillary pain', 'Chills', 'Headache', 'Hyperhidrosis', 'Hypersomnia', 'Lymphadenopathy', 'Pain', 'Pyrexia']",1,MODERNA,IM 924037,ME,45.0,M,"received vaccine 12/21 and on 12/29 noted bilateral ear lobe swelling redness and facial flushing. on 12/30/2020 patient reports increased hive like rash on abdomen, trunk arms, and neck redness. Patient seen at her PCP and diagnosed with allergic reaction. Patient has taken benadryl and clariten and symptoms resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/29/2020,8.0,WRK,"Valcyclovir, Certriline, Vitamin D, Biotin",denies,denies,,wine causes congestion,"['Ear swelling', 'Erythema', 'Flushing', 'Hypersensitivity', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 924042,ME,31.0,F,received vaccine 1600 and then developed hive like rash on anterior neck only which has continued and patient will be evaluated today 12/24/2020. She did not develop any other allergic reaction symptoms and only other symptom is mild soreness to her arm where she received the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,WRK,"Wellbutrin, Lexapro, multivitamin, Vit D, Vit B12, Biotin",,,,allergic to a multivitamin with hives 3 years ago,"['Injection site pain', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 925060,,59.0,F,"Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea and numbness and tingling in fingertips 5 minutes after administration of vaccine and proceeded to bathroom. Patient with unwitnessed vomiting prior to RN assessment. RN assessed patient and taken safely to private evaluation room. AED pads applied per protocol. Epi-Pen administered. EMS called. Vital signs stable. Patient complained of itching and erythema in left arm around injection site. MD evaluated patient and advised to be further assessed in ER. Patient continuously evaluated by RN and EMS. Patient transported to ER in stable condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Anaphylactic reaction', 'Dizziness', 'Hypoaesthesia', 'Injection site erythema', 'Injection site pruritus', 'Nausea', 'Paraesthesia', 'Pruritus', 'Urticaria', 'Vomiting']",1,PFIZER\BIONTECH,IM 925061,,42.0,F,"Anaphylaxis, CoughWheeze & UrticariaPruritus History of asthma, Epipen given with good improvement.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Anaphylactic reaction', 'Cough', 'Pruritus', 'Urticaria', 'Wheezing']",UNK,MODERNA, 925062,,48.0,F,"Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: employee with an adverse reaction to the Covid vaccination. Reported to RN 10 minutes post vaccination Lips numbness/ tingling, throat fullness and slightly anxious. NP assessed employee and 50mg of IM Benadryl given in the opposite arm (right). No SOB or wheezing noted. VS pre treatment 158/99, 98%-RA, 98-HR, 18-RR. Ten minutes post treatment Lip tingling and throat fullness improving. At 20 minutes post treatment all S&S of adverse reaction resolved VS taken throughout even with 60 minutes of observation time total VS 139/84, 99%-RA, 81-HR, 14-RR. She is feeling tired and will consider calling for a ride to go home as advised by staff.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Anaphylactic reaction', 'Anxiety', 'Fatigue', 'Hypoaesthesia oral', 'Paraesthesia oral', 'Salivary hypersecretion', 'Tachycardia', 'Throat tightness']",1,PFIZER\BIONTECH,IM 925190,,43.0,M,"Anaphylaxis Narrative: Pt reported trouble swallowing around 20 minutes into the observation period and was transferred to the treatment area in the vaccine clinic. Vital signs were assessed by a Registered Nurse and a Physician. Oxygen saturation was noted to be 88% on 2 liters of O2 by nasal cannula. Verbal order received at 10:03am from Physician and EpiPen administered to right thigh with improvement of symptoms. She was transferred to the Emergency Department (ED) via stretcher. In the ED, she was re-dosed with an EpiPen secondary to her airway type symptoms. She was reevaluated after 15 minutes and received Solu-Medrol, Pepcid, Benadryl IV, as well as IV fluids. She also received Ativan for her generalized jitteriness and anxiety. She improved and felt significantly better at approximately 11:43am. She was monitored for 3 hours in the ED and was discharged home at 3:34pm in good clinical condition and advised to continue to take Benadryl as needed. She carries and EpiPen on her person and was advised to return immediately if symptoms return.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Anaphylactic reaction', 'Anxiety', 'Dysphagia', 'Feeling jittery']",1,PFIZER\BIONTECH,IM 922283,,19.0,F,"red dotted rash only on my chest. the rash starts at my jaw line and goes behind my ears, around the front on my neck, then my entire chest in between each best down to bra strap line and stops.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/05/2021,3.0,UNK,birth control,none,none,,none,"['Rash erythematous', 'Rash macular']",1,MODERNA,SYR 922284,ID,30.0,F,"Itching, pain, swelling, and redness at injection site; fevers, myalgia, fatigue, malaise.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2020,01/04/2021,366.0,PUB,Oral contraceptives,None,None,"Varicella vaccine, diffuse swelling, aged 28, vaccinated June 2018",Varicella vaccination,"['Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Malaise', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 922285,MD,27.0,F,"Painful, swollen lymph node in arm of injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,UNK,"Turmeric, melatonin",None,None,,None,"['Lymph node pain', 'Lymphadenopathy']",UNK,MODERNA, 922286,NV,29.0,F,"Left side, neck near collar bone. Swollen bulge in neck (lymph nodes?) severely painful and swollen. No treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,,,SEN,Paraguard IUD,None,None,,"PCN, Latex","['Neck pain', 'Swelling']",1,MODERNA,SYR 922287,IL,27.0,F,"Arm pain, extreme fatigue, body/muscle aches, fever, shortness of breath, sensitivity to light, unable to go to work or preform daily activities Onset 5 hours after vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Multivitamin,Unknown virus tested negative PCR COVID Influenza RSV,,,,"['Dyspnoea', 'Fatigue', 'Loss of personal independence in daily activities', 'Myalgia', 'Pain', 'Pain in extremity', 'Photophobia', 'Pyrexia']",1,MODERNA,IM 922288,CA,39.0,F,"Itchy, red, swollen lump at injection site, 2-3 inches in diameter. Painful, swollen axillary lymph nodes on the same side (right).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,,None,None,,"Penicillin, cephalosporins","['Axillary pain', 'Injection site erythema', 'Injection site mass', 'Injection site pruritus', 'Injection site swelling', 'Lymphadenopathy']",1,MODERNA,IM 922289,CA,34.0,F,I suffered a miscarriage on 12/31/2020. I was at 5 weeks gestation. This was my first pregnancy. I had uterine bleeding and abdominal cramps on 12/31/2020 and underwent evaluation by my Obstetrician and was diagnosed with a miscarriage after ultrasound.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/31/2020,14.0,PVT,Pre natal vitamins,No,No,,No,"['Abdominal pain', 'Abortion spontaneous', 'Human chorionic gonadotropin decreased', 'Ultrasound antenatal screen abnormal', 'Uterine haemorrhage']",1,PFIZER\BIONTECH,IM 922290,NY,41.0,M,"Fever of 101 for the first 48 hrs, ibuprofen, fever went down Pain in the arm for first 24 hrs, ice, ibuprofen, pain went away",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,WRK,None,None,None,,None,"['Pain in extremity', 'Pyrexia']",UNK,MODERNA,IM 922291,GA,37.0,F,Ipsilateral axillary swelling and tenderness beginning 2 days after vaccine with notably increasing swelling and tenderness at 5 days post vaccine. Continuing to monitor at home.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PVT,Junel-Fe Wellbutrin Synthroid,N/a,N/a,,Sulfa drugs,"['Oedema peripheral', 'Tenderness']",1,MODERNA,IM 922292,MA,52.0,F,"Patient went to get in her car after completing time of wait after vaccination, felt cloudy, compared it to how she feels after having a glass of wine, denied vision changes but states perception of environment felt foggy. EMT assessed patient, HR normal at 71, O2 100%, Bp elevated at 182/100, patient did report anxiety, monitored for another 15-20min until patient felt better, cloudiness improved, Bp improved. Advised to consult with PCP re: Bp.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,WRK,,,,,,"['Anxiety', 'Feeling abnormal']",1,MODERNA,IM 922293,TX,66.0,F,"Significantly sore left shoulder (injection arm) with pain now radiating up into neck & downward around shoulder blade, severe headaches, nausea (no vomiting), sore throat, FATIGUE, chills/cold sweat, general body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,Synthroid Lamictal Metoprolol Plavix Ranexa Isosorbide mononitrate Sublingual nitro Zinc Vit D3 Vit C Vit B complex Ezetimbe Pravastatin Omega 3 Aspirin 81mg Tylenol 650 QVAR inhaler Prednisone Melatonin,,Asthma Heart disease Hypothyroidism Hypercholestemia Rheumatism,,"Allergic to : codeine Hydrocodone Ibuprofen Some statins Morphine Allergic to mountain cedar Reactive airway disease to some chemicals, fragrances","['Chills', 'Cold sweat', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Oropharyngeal pain', 'Pain']",1,PFIZER\BIONTECH,SYR 922294,,50.0,F,Pt states that she developed a rash on her chest along with chest and back pain around 1012pm on 4Jan2021,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,MIL,None,None,None,,NKA,"['Back pain', 'Chest pain', 'Rash']",1,MODERNA,IM 922295,MA,60.0,F,"19th received Covid Vaccine at noon 21st negative Covid surveillance test completed due to ED Cluster 22nd Bedtime approx. 2100 A very strange feeling of overwhelming fatigue ""spacey feeling"""" 23rd nausea dizzy general malaise 24th nausea dizzy general malaise 25th nausea dizzy general malaise Contacted Health Service 26th still nauseous dizzy general malaise and then chills Health Service Ordered Covid Test 26th negative Covid. 26th video appointment with PCP states no need for labs feels it's Vaccine related 27th minimal nausea no chills episodes of feeling ?spacey? and tired 28th Minimal nausea 29th Morning nausea and fatigue 30th Morning nausea and fatigue 31st increased nausea and fatigue all day easing as day progresses ""spacey"" with fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/22/2020,3.0,WRK,,,One kidney from birth,,Sulfa,"['Chills', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Malaise', 'Nausea', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 922296,UT,54.0,F,"Approximately 10 minutes after injection tingling in right hand, red splotchy skin on palm of hands and forearms. Approximately 15-20 minutes after injection. Tingling in feet and lower extremities. Thirty minutes after injection slight itching at injection site. Approximately 1 1/2 hours after injection splotchy red skin inside both thighs and mild generalized itching. At 2:00 pm that day of injection tingling began in face with slight swelling in cheeks. Itching lasted 3 days. Currently intermittent itching since Monday 01/03/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Tecfidera, Lyrica, Baclofen, Pantoprazole, Methylphenidate, Inderal, Hydrochlorothiazide, Micardis, Metformin, Trazodone, Miralax, Atorvastatin, True Biotics, Lipoic Acid, Women's One A Day, Caltrate, PreNatal Vitamin with Folic Acid, Lexa",Stomach Flu 10/31/2020,"Multiple sclerosis, Hypertension, Pre-Diabetes, Elevated cholesterol, GERD, OSA, Osetoarthritis, IBS/Constipation, Burning mouth syndrome, GI Motility problems","Flu vaccine 11/09/2020; Redness, swelling, itching below injection site (right arm). Age 54","Penicillin, Sulfa, Erythromycin, Ampicillin, Keflex, Flagyl, Copaxone, Silicone, Advil, Encaprin,","['Injection site pruritus', 'Paraesthesia', 'Pruritus', 'Rash macular', 'Swelling face']",1,PFIZER\BIONTECH,SYR 922297,TX,20.0,F,Shortness of breath Dizziness Nausea Soreness in arm of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,UNK,N/a,N/a,N/a,,N/a,"['Dizziness', 'Dyspnoea', 'Injection site pain', 'Nausea']",1,MODERNA,SYR 922298,CA,25.0,F,Nausea vomiting chills headache fever,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PHM,,Covid 19 positive,Asthma,,,"['Chills', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 922299,MA,58.0,F,"I was instructed to stay for 30min as i have been anaphylatic to cipro in past. at 30min was told i could leave. while driving home on rt 91 my cheekbones became numb. then slowly a few min later my cheeks became numb. a few min later my lips became numb. as i was driving off exit to rt 5 in longmeadow i developed a lump in my throat. i turned around at top of exit and went back to highway to go to ER. this was approx 1645-1650. i went to ER arrived approx 1655. i was shaking. my bp and pulse were elevated. no tingling or swelling in my face. nurse checked my pupils and my smile and were wnl. no history of bells palsy. i received iv fluids, solucortef 125mg ivp, pepcid 20mg ivp, and benedryl 25mg ivp approx 1840pm. approx 45 min after solucortef numbness better but not gone. it started to come back a little more before discharge, which i let md know. she discharged me with scripts for epi-pen, prednisone, and OTC pepcid and benedryl. follow up with my pcp's office in am 12/24 at 10am with his NP. total time with facial numbness/lip numbness 29 hours.",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,prilosec 20mg q hs pseudofed 1 tablet at 7:15 am and 4:15pm that day. lo loestrin fe 1 tablet a day (days 1-26) off 2 days,cold symptoms that started 12/15/20. covid tested 12/16/20 negative. cold symptoms were diminished on 12/23/20 but still had slight runny nose. (used pseudofed 30mg tab),mild asthma,,"anaphylaxtis to cipro- see ER visit 4/2012. throat swelling, facial and eye swelling , head to toe hives. lasted 5 days with prednisone taper, benedryl and pepcid.","['Blood pressure increased', 'Heart rate increased', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Laboratory test', 'Sensation of foreign body', 'Tremor']",1,MODERNA,IM 922300,MA,41.0,F,"EE starting with migraine about 5 minutes after receiving vaccine. That night had rash to trunk and back with the chills. Took benadryl that night. Next am, had swollen eyes and hands. Within 24 hours,those sx resolved- but then had 48 hours of sx similar to past covid infection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,,,,,,"['Chills', 'Eye swelling', 'Migraine', 'Peripheral swelling', 'Rash']",1,MODERNA,IM 922301,MA,30.0,M,Severe chills and weakness. Ran 6 miles day of getting vaccinated (21st) unable to even reach the end of the street on the 22nd.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,WRK,Vitamins,None,None,,None,"['Asthenia', 'Chills', 'Loss of personal independence in daily activities']",1,PFIZER\BIONTECH,IM 922302,NY,27.0,M,"Moderna COVID-19 Vaccine EUA Low grade fever (100.4), severe injection site pain/swelling, night sweats, chills, body aches, severe muscle/joint pain, headache, severe dizziness, nausea, anorexia; lasted for 1.5 days following the vaccine administration. Day 2: injection site erythema, continued pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,PVT,"Biotin, Finasteride, Lexapro",None.,None.,,Mango,"['Arthralgia', 'Chills', 'Decreased appetite', 'Dizziness', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Nausea', 'Night sweats', 'Pain', 'Pyrexia']",2,MODERNA,IM 922303,,,U,"Symptoms began with diarrhea 2 days after receiving the first dose of the Pfizer covid vaccine and then included body aches, mild sore throat, and mild headache, and intermittent chills. Symptoms lasted approximately 14 hours. I am a nurse at the hospital where I received the vaccine. I had no known covid contacts.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Chills', 'Diarrhoea', 'Headache', 'Oropharyngeal pain', 'Pain', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH,IM 922304,ND,38.0,F,"Employee Recollection: Wednesday and Thursday felt kind of weak and more tired than normal, but thought nothing of it. In the early afternoon on Friday the symptoms got worse. Tired and confused. I slept through my alarm and woke up to my mom, who was watching my daughter for me, trying to wake me up. I was very confused, dizzy and weak. My mom said I was really out of it, and that I had a really hard time focusing on what she was trying to say to me. When I checked in for work my O2 stats were in the upper 80's lower 90's. My temp was also in the lower 90's. That was after numerous attempts at taking my o2 stats and temps. Co-worker said I was very confused, tired, dizzy and weak. She said there were times when I was walking that I would reaching for walls and railings to regain my balance. I left work at 6am Saturday morning. I went home and went straight to bed. Slept all day long until a few hours before my shift started at 9:30 P.M. since then I've been feeling better, but my temp and 02 stats are still low. But I'm continuing to monitor symptoms. I'll keep you posted if anything changes.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,OTH,Unknown,None,None,,None listed,"['Asthenia', 'Balance disorder', 'Body temperature abnormal', 'Confusional state', 'Disturbance in attention', 'Dizziness', 'Fatigue', 'Oxygen saturation decreased']",1,MODERNA,IM 922305,OR,30.0,F,"Burning sensation in throat, mild color change in neck and chest- beginning around 8am lasting until about 10am. Uncontrollable tremors, feeling like I need to constantly be moving and tachycardia- started around 830a started to diminish once I took a benadryl around 10a. Headache, fatigue and nausea beginning hours after vaccine, still present on 01/05. Sore arm at injection site and swollen axillary lymph node in same arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Methotrexate, levothyroxine",No illnesses noted,Recurrent mouth ulcers-no specific diagnosis. Hypothyroidism,,Dapsone and bell peppers,"['Fatigue', 'Feeling abnormal', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Nausea', 'Skin discolouration', 'Tachycardia', 'Throat irritation', 'Tremor']",2,PFIZER\BIONTECH,SYR 922306,OH,51.0,M,Fever of 100.6,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,SEN,,,,,,['Pyrexia'],1,PFIZER\BIONTECH,IM 922307,CA,37.0,M,"Headache, chills, myalgias, joint pain, fever started approximately 12 hours after vaccine and lasted approximately 12 hours total. Most symptoms improved with Tylenol and naproxen but fever 100.4F persisted for 6 hours despite medications.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Bupropion XL,None,None,,None,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 922308,AZ,55.0,F,"High fever to 102.5, chills, nausea, severe headache, body aches, unable to function with severe weakness for 1 day, very sore arm, swollen arm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Levothyroxine, Vitamin D, Vitamin B, Iron, Potassium, Lisinopril",None,"Obesity, HTN, Hypothyroid, Gastric Bypass (2002)",,"Adhesive, Codeine","['Chills', 'Headache', 'Loss of personal independence in daily activities', 'Nausea', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 922309,PA,29.0,M,"Mild nausea, diffuse myalgia, chills, fever to 101.5.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Advair, albuterol, spiriva",,Asthma,,Mold,"['Chills', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 922310,MA,35.0,F,"After 1 week of receiving the vaccine, I woke up with my arm red, warm, swollen and itchy. It had become that way on the 3rd day but had resolved. It has now resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,PUB,Nexplanon,,Hx of Asthma,,"Peaches, plums, apples, kiwi, pears","['Erythema', 'Peripheral swelling', 'Pruritus', 'Skin warm']",1,MODERNA,IM 922312,CT,37.0,F,"Migraine headache, vomiting 2pm day of Overnight fever 101.5",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,UNK,Zoloft 150 mg Synthroid 25 meg Prenatal vitamin,,,,,"['Migraine', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 922313,MD,36.0,F,"Day 1 of shot- soreness after a couple of hours at injection site Day 2- extreme fatigue (slept most of day), severe pain in left shoulder (couldn't move arm forward), chills, widespread muscle and joint aching Day 3- improved widespread S/S but still with pain specifically with left shoulder flexion and internal and external rotation Day 4- felt significantly better and able to raise arm overhead without pain, able to go about daily tasks Day 5- 5:45 am in morning- woke up with injection arm in severe spasm- painful to lift forward and rotate again, noticed decrease in sensation in anterolateral left shoulder to touch Day 6- 4:45 am- woke up with left arm in spasm again, pain with movement or weight bearing up to 8/10, feels swollen in chest and anterolateral left shoulder, referred pain in front of arm into biceps insertion, pain in injection site in anterolateral aspect of left shoulder",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,OTH,"Iron, omega 3, prenatal vitamins, zyrtec, flonase",None,None,,"Amoxicillin, percocet, steroids, seasonal","['Arthralgia', 'Chills', 'Fatigue', 'Injection site pain', 'Muscle spasms', 'Myalgia', 'Pain', 'Paraesthesia', 'Swelling', 'Weight bearing difficulty']",1,MODERNA,IM 922314,IA,34.0,M,1 hour after injection mild headache starts. 6 hours after injection headache intensity increases cold sweat starts run down feeling start cognitive fog sets in 9 hour after injection headache turn in to migraine. sweating on and off with hot and cold chills 12 hours after injection my joints began to hurt arm pain increases to the point its hard to move my arm and i now feel flu like and am more run down i am now 9 days out i still have arm pain still feel flu like and even more run down with a heavy chest i can still tease and smell but feel like i have a full blown flu and my skin is on fire but have no fever,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,WRK,N/a,Na,"Chronic fatigue syndrome, spondylitis, fibromyalgia",,Macro antibiotics erythromycin,"['Arthralgia', 'Chest discomfort', 'Chills', 'Cognitive disorder', 'Cold sweat', 'Feeling abnormal', 'Feeling of body temperature change', 'Hyperhidrosis', 'Influenza like illness', 'Migraine', 'Mobility decreased', 'Pain in extremity', 'Skin burning sensation']",1,MODERNA,SYR 922316,,27.0,F,Sudden onset shakiness and became light headed with tunnel vision. Almost passed out. Episode lasted about 5 minutes but generalized weakness lasted for about an hour.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PUB,"Synthroid, Cetirizine",,Hypothryoidism,,none,"['Asthenia', 'Dizziness', 'Tremor', 'Tunnel vision']",1,PFIZER\BIONTECH,IM 922317,,43.0,F,"Urticaria to neck at 11:00, approx 2.5 hrs after immunization. No airway involvement. Took Zyrtec 10mg.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,MIL,Synthroid,None,None,,"Codeine, erythromycin, wellbutrin, metronidazole, penicillin",['Urticaria'],1,MODERNA,IM 922318,NJ,28.0,F,Body aches and fatigue about 5 hours after injection. Worsening body aches and head ache around 9pm on same day. 5am on 1/6 severe body aches and temperature of 100.3,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Body temperature increased', 'Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 922319,VA,37.0,F,Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,UNK,None,None,None,,None,['Pyrexia'],UNK,PFIZER\BIONTECH, 922320,NJ,54.0,F,"at approximately 11:30 am 12/23/20 began to have: generalized body aches and weakness,headache,severe pain in left arm , chills, temperature max 99.9 degrees F; extreme fatigue,drowsy,small area of redness at injection site with mild itchiness. Symptoms resolved approximately 12 hours later. I took Motrin 800mg at onset of symptoms and Excedrin extra strength (2) caplets approximately 8 hours later for lingering headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,PVT,"Pepcid,Probiotic gummies,Multivitamin gummies,VitaminD3,Excedrin",none,none,,"Levaquin,Reglan,Augmentin","['Asthenia', 'Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pruritus', 'Pain', 'Pain in extremity', 'Somnolence']",1,MODERNA,IM 922321,MS,42.0,F,"Raised, itchy red circular area to left arm below injection site 1 week after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,WRK,"Provigil, multivitamin, Vit D3, b complex",None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 922322,FL,28.0,F,Around 1/5/2021 started feeling slight tingling of R foot which has carried on till present time 1/6/21 0600. Around 1/5/21 2100 started experiencing frequents stools leading to persistent diarrhea until present time.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Synthroid 88 mcg, Tylenol 500 mg",,Hashimotos thyroiditis,,Keflex,"['Diarrhoea', 'Paraesthesia']",1,MODERNA,IM 922324,WI,46.0,F,"Initial sore arm, approximately 31 hours after injection developed a slight headache. By 6am on the 2nd day had an intense migraine headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,none,none,Celiac,,IV Iron,"['Migraine', 'Pain in extremity']",UNK,MODERNA,IM 922325,TN,61.0,F,Welts to lower extremity evening on the day of vaccination. Systemic rash 4 days later with severe itching.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/02/2021,4.0,PUB,"Tylenol, Bystolic, Xeralto, vitamin D, famotidine",None,"HTN, A-fib, arthritis",,"Dilantin, penicillin, cleocin, zithromax, effexor,","['Rash', 'Rash pruritic', 'Urticaria']",1,MODERNA,IM 922326,AZ,32.0,M,body aches / body chills / head ache / high fever / lack of appetite / irritability. rest / hydration / small amounts of food / light activity to avoid bed sorness. all at home,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,none,none,none,,none,"['Chills', 'Decreased appetite', 'Headache', 'Irritability', 'Pain', 'Pyrexia']",1,MODERNA,SYR 922327,MN,55.0,M,"Woke up very fatigued 12/25 only minimal activity performed creating additional fatigue. Was sleeping 12 plus hours a day without feeling rested in the least. No problems with sleep. Also had heaviness of chest - felt like rib cage made of iron- this dissipated by the 28-29th. No excessive cough or fever, did have dyspnea with any exertion and this continues but seems to be lessening. Was not able to work due to fatigue. Yesterday remained tired but felt noticeably different-felt lighter-and today seems promising.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/25/2020,3.0,PVT,"multivitamin, melatonin 3mg, serequel 50mg",none,none,,nka,"['Chest discomfort', 'Cough', 'Dyspnoea exertional', 'Fatigue', 'Impaired work ability', 'Laboratory test normal', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 922328,NH,63.0,F,Developed itchy painful rash 8 days after vaccination at injection site about 4 inches x 4 inches,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/06/2021,8.0,WRK,LISINOPRIL CLIMARA 0.25 MCG PATCH MULTIVITAMINS VITAMIN D VITAMIN K COQ10,NONE,MIGRAINE HEADACHE HYPERTENSION,,SULFA FUROSEMIDE,"['Injection site rash', 'Rash', 'Rash pruritic']",1,MODERNA,IM 922329,PA,53.0,F,Swelling on chin area that was filled with juvaderm 7 months ago,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PUB,Lisinopril Milk thistle. Mvm. Vit d,No,History of facial filler,,Nka,['Swelling face'],1,MODERNA,IM 922330,NY,41.0,F,"enlarged lymphnodes not decreasing in size, chronic fatigue, NVDx5 days, fever, chills, general unwellness since vaccine. Nausea and Diarrhea hasn't subsided yet and lymphnodes still enlarged.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PVT,None,none,none,,none,"['Chills', 'Diarrhoea', 'Fatigue', 'Influenza virus test negative', 'Lymphadenopathy', 'Malaise', 'Metabolic function test', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting', 'White blood cell count decreased']",1,MODERNA,IM 922331,RI,44.0,F,"Initial swelling and soreness right after injection. Swelling and pain continued for the next few days, Motrin 800mg and Benadryl 25mg at bedtime were taken. Swelling and pain persisted. Area became hard, red, itchy and raised over the holiday. Swelling, redness and itchiness became worse over the weeknd into Monday. I was unable to lift my arm, bring it behind my back or reach. It was very painful and hot. I then contacted employee health. They did not feel it was infected but was the delayed reaction to the moderna vaccine. I did not feel comfortable with this and I then contacted my physician who looked at it and felt it was in fact cellulitis, I was sent for a ultrasound to rule out a blood clot and labs and an IV infusion of Rocephin as well as oral antibiotics. I received my first infusion yesterday. The swelling has improved greatly, however the redness has spread beyond the marked area on my arm and I will be receiving another dose of IV Rocephin today. My labs showed my CRP was elevated and my ALT/AST were elevated as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,Bystolic 5mg Levothyroxine 100mcg Pristiq 100mg alprazolam 0.05 mg flexaril 10mg prn motrin 800mg prn,,Chronic Lyme Disease,,Shellfish,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'C-reactive protein increased', 'Cellulitis', 'Differential white blood cell count', 'Erythema', 'Full blood count', 'Immediate post-injection reaction', 'Induration', 'Joint range of motion decreased', 'Pain', 'Pain in extremity', 'Pruritus', 'Skin warm', 'Swelling', 'Ultrasound scan']",1,MODERNA,IM 922332,TN,30.0,F,"99.7 fever, fatigue, swelling and painful blisters on tongue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PUB,"Daily multivitamin, cetirizine, biotin, vitamin D",None,None,,None,"['Fatigue', 'Pain', 'Pyrexia', 'Swollen tongue', 'Tongue blistering']",1,MODERNA,SYR 922350,MO,11.0,F,"mildlydiaphoretic / she did sweat; She complains of being thirsting; she felt like she was going to throw up; dizzy; This spontaneous report was received from a healthcare professional via Food and Drug Administration (FDA) referring to a 11 years old female patient on 22-OCT-2020. The patient's concomitant therapies included lithium carbonate and chlorpromazine hydrochloride (THORAZINE). The patient had no known allergies (NKA)/no known drug allergies (NKDA). The patient had no other illness at the time of vaccination or up to one month prior. The patient had no chronic or long-standing health conditions. The patient did not have an adverse event following the previous vaccine. On 26-SEP-2019, at 13:25, the patient came over to clinic and was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1602289, not valid, expiration date and dose detail were not provided) intramuscularly in the right arm (also reported as left deltoid) for prophylaxis. The patient was also vaccinated with the first dose of meningococcal acyw conj vaccine (crm197) (MENVEO) (lot# U6543AA, expiration date, dose detail and indication were not provided) intramuscularly in the left arm (it was also reported the patient was given meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) injection in the right deltoid) in the medication room. On 26-SEP-2019, at 13:30, the patient walked out to hallway in clinic to get a stuffed animal and she complained of (c/o) being dizzy per a doctor. The doctor assigned her to a chair in the clinic. She was mildly diaphoretic. The nurse took her vital signs (VS) and the patient then said, she felt like she was going to throw up. She closed her eyes briefly. The nurse gave her a few sternal rubs. She responded to the sternal rubs, she c/o being thirsting. Epinephrine pen was given per the doctor. The patient was able to answer question appropriately then she stated she felt better. VS results as following: pulse oximetry was 96% to room air (RA), pulse was 84 (unit not provided), temperature was 97.5 (unit not provided), blood pressure (b/p) was 97/64 (unit not provided). The staff called 911. When ambulance arrived, she was able to answer questions by emergency personnel. She was transported to emergency room (ER) per ambulance. She returned from ER around 17:00 on the same day. The therapist checked in with the patient. She was monitored through out night and legal guardian was notified. The patient recovered from above events in 2019. The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not provided. Follow-up information has been received from a physician and a nurse on 31-DEC-2020, referring to a currently 12 year old female patient. The physician stated that it was not clear when this happened, but stated that the patient sweated and vomiting, however, did not experienced dizziness. Additionally, was reported that the clinic was a residential facility, where children were admitted and discharged and if this was the only child anything had ever happened with, she believed the child was still at the facility (hospitalization). Additional information received from the nurse that vaccinated the patient and stated that on 26-SEP-2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1602284 (previously reported as ""1602289""), expiration date 26-SEP-2021, intramuscularly in the left deltoid (previously reported as ""right arm""), meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) lot # U6543AA, expiration date 23-FEB-2021 (lot # previously reported for meningococcal ACYW conj vaccine (CRM197) (MENVEO)), intramuscularly, in the left deltoid (previously reported as ""right deltoid"") and meningococcal ACYW conj vaccine (CRM197) (MENVEO). On the same date, the patient experienced hyperhidrosis, thirst, vomiting and dizziness. The patient recovered from adverse events. These adverse events were previously reported to doctor and to manufacturer. The vaccine was used according to the instruction leaflet. There was no a previous temperature excursion. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent",Not Reported,,Not Reported,Yes,,Not Reported,Y,09/26/2019,09/26/2019,0.0,UNK,lithium carbonate; THORAZINE; GARDASIL 9 SYRINGE (DEVICE);,,,,,"['Dizziness', 'Hyperhidrosis', 'Nausea', 'Thirst', 'Vomiting']",1,SANOFI PASTEUR, 922373,OH,,M,"hospitalized in 2016 because my temperature and white blood cell count were high.; hospitalized in 2016 because my temperature and white blood cell count were high.; I have ping-pong ball sized bumps on my armpits, neck, stomach, and knees.; I have rashes behind my knees and sometimes have sharp or throbbing pain in my arms and legs.; I have rashes behind my knees and sometimes have sharp or throbbing pain in my arms and legs./ I have needle-like pain in my feet when I walk.; I have lost my balance and fallen; fallen; I feel a sharp burst of pain in my brain and I have short term memory loss.; I feel a sharp burst of pain in my brain and I have short term memory loss.; smoke marijuana all the time.""; My fingers twitch/spasm randomly without me feeling it.; I have ping-pong ball sized bumps on my armpits, neck, stomach, and knees.; I have ping-pong ball sized bumps on my armpits, neck, stomach, and knees.; I have ping-pong ball sized bumps on my armpits, neck, stomach, and knees.; diverticulitis; I couldn't eat because of the needle-like pain in my stomach. I had an endoscopy, colonoscopy, tests for Diverticulitis and Irritable Bowl Syndrome (IBS).; I couldn't eat because of the needle-like pain in my stomach. I had an endoscopy, colonoscopy, tests for Diverticulitis and Irritable Bowl Syndrome (IBS).; I couldn't eat because of the needle-like pain in my stomach. I had an endoscopy, colonoscopy, tests for Diverticulitis and Irritable Bowl Syndrome (IBS).; I threw up a lot and developed a hernia and lipoma on my side.; I threw up a lot and developed a hernia and lipoma on my side.; I threw up a lot and developed a hernia and lipoma on my side.; fingers feel ice cold but the rest of my fingers feel normal.; My fingers twitch/spasm randomly without me feeling it.; I started having seizures in 2014.; This spontaneous report was received from a male patient of unknown age via company representative, reporting on himself. The patient's medical history included sports injury involving knees. Information rgeading concurrent conditions and concomitant medications was not provided. On an unknown date in 2008 or 2009, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)(strength, dose, frequency, lot # and expiration date were not provided), intramuscular for prophylaxis. It was reported that on an unknown date in 2011, the patient's son was born and had ""delayed speech and learning abilities, asthma, and his legs hurt."" The patient stated he is not sure if his son was experiencing these ailments due to the vaccine he received before his son was born (case cross reference 2101USA001097) Subsequently, after the patient received the vaccine he could not eat because of the needle-like pain in his stomach. He had an endoscopy, colonoscopy, tests for Diverticulitis and Irritable Bowl Syndrome (IBS), he threw up a lot and developed a hernia and lipoma on his side. Sometimes his middle fingers feel ice cold but the rest of his fingers feel normal. The patient's fingers twitch/spasm randomly without him feeling it. The patient started having seizures in 2014. He lost his job in 2016 because of all the medical issues he was experiencing. The patient was hospitalized in 2016 because of his temperature and white blood cell count were high. He had ping-pong ball sized bumps on my armpits, neck, stomach, and knees. He had rashes behind the knees and sometimes had sharp or throbbing pain in the arms and legs. The patien had needle-like pain in his feet when he walk. The patient had also lost the balance and fallen and feel a sharp burst of pain in the brain having short term memory loss. The patient also reported that he smoke marihuana all the time."" The patient was treated with omeprazole Magnesium and cortisone shots. At the reporting time the outcome of the aforementioned events was reported as not recovered. The reporter did not provide the causality assessment between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). Upon internal review, the events of diverticulitis and seizure were considered to be medically significant. All the events were considered to be disabling as the patient lost his job. This is one of 3 report from the same source.; Sender's Comments: US-009507513-2101USA001097: US-009507513-2101USA001098:",Not Reported,,Not Reported,Yes,,Yes,N,,,,OTH,,,Medical History/Concurrent Conditions: Knee injury,,,"['Abdominal pain upper', 'Amnesia', 'Balance disorder', 'Colonoscopy', 'Diverticulitis', 'Endoscopy', 'Fall', 'Headache', 'Hernia', 'Irritable bowel syndrome', 'Lipoma', 'Loss of employment', 'Muscle spasticity', 'Muscle twitching', 'Pain', 'Pain in extremity', 'Peripheral coldness', 'Pyrexia', 'Rash', 'Seizure', 'Vomiting', 'White blood cell count increased']",UNK,MERCK & CO. INC.,OT 922374,NM,,M,"reoccurring pneumonia; congestive heart failure; herpes zoster dermatitis of the eyelid; Information has been received regarding a case in litigation from a lawyer and referred to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 15-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered reoccurring pneumonia resulting in multiple hospitalizations. The patient was diagnosed with pneumonia and congestive heart failure. The patient additionally suffered from and was diagnosed with herpes zoster dermatitis of the eyelid. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causality assessment between all the events and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer. Upon internal review, pneumonia, congestive heart failure and herpes zoster dermatitis of the eyelid were determined to be medically significant. The lawyer considered all the events to be disability.",Not Reported,,Not Reported,Yes,,Yes,N,11/15/2013,,,UNK,,Prophylaxis; Routine health maintenance,,,,"['Cardiac failure congestive', 'Ophthalmic herpes zoster', 'Pneumonia']",UNK,MERCK & CO. INC.,OT 922375,OR,,F,"varicella type rash; low-grade fever; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about medical history, concurrent condition and concomitant medication was not reported. In or around 28-JAN-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered a varicella type rash on her body and a low-grade fever. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events varicella type rash on her body and a low-grade fever was not recovered. The lawyer considered varicella type rash on her body and a low-grade fever to be related to zoster vaccine live (ZOSTAVAX). The lawyer considered the events varicella type rash on her body and a low-grade fever to be disability.",Not Reported,,Not Reported,Not Reported,,Yes,U,01/28/2011,,,UNK,,Routine health maintenance,,,,"['Pyrexia', 'Rash vesicular']",UNK,MERCK & CO. INC.,OT 922377,FL,52.0,F,"glaucoma; Eye pain both eyes; burning eyes; Nuclear catarct; possible sinus problems; migraine; This case was reported by a lawyer and described the occurrence of glaucoma in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 22nd May 2018, the patient received Shingrix (intramuscular) .5 mg. On an unknown date, an unknown time after receiving Shingrix, the patient experienced glaucoma (serious criteria GSK medically significant) and eye pain. On an unknown date, the outcome of the glaucoma and eye pain were unknown. It was unknown if the reporter considered the glaucoma and eye pain to be related to Shingrix. The initial information received on 10 December 2020 via medical records. As per records the female patient was non smoker.As per records on 22 May 2018 and on 19 October 2018, she had Shingrix 50mcg injection 0.5 ml into the muscle, repeat in 2 to 6 months. On 19 February 2019, she had follow-up of ocular pain, both eyes. She described to have pain as aching and burning and stated that was an aggravating problem. This eye pain began several months ago and is symptomatic almost constantly. She states that this seems to be gradually improving. On 29 January 2019, she stated eyes have been painful since having the shingles shot. She had Ocular pain, possible sinus problems, Inflammation from shingles shot, nuclear cataract and migraine",Not Reported,,Not Reported,Not Reported,,Not Reported,U,05/22/2018,,,UNK,,,,,,"['Cataract nuclear', 'Eye pain', 'Glaucoma', 'Inflammation', 'Migraine', 'Pain']",UNK,GLAXOSMITHKLINE BIOLOGICALS,IM 922379,OK,78.0,M,"suspected vaccination failure; developed Myasthenia Gravis after the second Shingrix; had shingles when he received his second vaccination / he still has shingles; is very Painful; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had Shingles in February 2020) and shingles. Concurrent medical conditions included shingles. In July 2020, the patient received the 1st dose of Shingrix. On 24th September 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix and less than 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), myasthenia gravis (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the myasthenia gravis, shingles and pain were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix. It was unknown if the reporter considered the myasthenia gravis to be related to Shingrix. Additional details were reported as follows: The patient had shingles in July 2020 when he received his first vaccination of Shingrix in his right arm and still had shingles when he received his second vaccination of Shingrix in his left arm. He stated that he still had shingles, but it occurs intermittently and was very Painful. He had been to his pharmacy, his doctor, the urgent care and the emergency room and had no relief. He developed Myasthenia Gravis after the second Shingrix dose. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR242160:Same reporter",Not Reported,,Not Reported,Not Reported,,Not Reported,N,07/01/2020,,,UNK,,Shingles,Medical History/Concurrent Conditions: Shingles (had Shingles in February 2020); Shingles,,,"['Herpes zoster', 'Myasthenia gravis', 'Pain', 'Vaccination failure']",1,GLAXOSMITHKLINE BIOLOGICALS, 922381,MS,52.0,F,"the top of her stomach felt swollen and gassy; Diarrhea/had diarrhea that was like liquid-y water; top of her stomach had a bad burning sensation; Vomiting; she got choked on some saline and sweat ran down her face, and she had to concentrate on breathing; sore throat with a mild cough, like she needed to be clearing her throat; sore throat with a mild cough, like she needed to be clearing her throat; got a chill; food was not tasting right; arm was sore; could not raise her arm; her weight on 21Dec2020 when she got the vaccine, was 200.6, but her weight today, was 196.0 pounds; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unspecified route of administration on 21Dec2020 on left upper arm at a single dose for COVID-19 prevention. Current medical history included a lung disease called asthma and allergies, diagnosed in her late 20's; Diabetes Type 2, diagnosed about 10 years ago and High Blood pressure, diagnosed when she was in her 30's. Caller also wanted to include that she did have COVID before, she had COVID in Jul2020. Current concomitant medications included salbutamol (ALBUTEROL) at 2 Puffs via inhalation, twice daily for asthma; Unspecified Blood Pressure Medication One pill, once daily by mouth in the morning; Unspecified Nasal Spray 1 spray in each nare, once daily via nasal inhalation; montelukast sodium (SINGULAIR) at 1 pill via oral, once a day for allergies; metformin at 1 pill, daily, by mouth for Diabetes Type 2. The patient stated that her place of employment did not give her the card that has the lot number on it, they said they would give it to her with her second injection. The patient did not know the dose received, just that it was the first in the series. The patient had no other vaccines on the same day as the COVID vaccine. The patient reported that her weight on 21Dec2020 when she got the vaccine, was 200.6, but her weight today, was 196.0 pounds. The patient received the vaccine on 21Dec2020, and as soon as she got the shot, her arm was sore like a flu shot. When she got the shot, she could not raise her arm past her shoulder without pain, but now she can raise her arm again. On Thursday, 24Dec2020, patient got a chill, and later that same night, food was not tasting right. On 25Dec2020, the chill continued, and she had a little bit of a sore throat with a mild cough, like she needed to be clearing her throat. On 26Dec2020 morning, the patient experienced vomiting when she woke up, and the top of her stomach had a bad burning sensation, and she had diarrhea. The patient stated that while she was vomiting, she got choked on some saline and sweat ran down her face, and she had to concentrate on breathing. But the patient stated that she vomited, had diarrhea, and the burning sensation, the whole day on Saturday. The patient stated that on 27Dec2020, it calmed down, and she did not vomit at all. The patient stated that she felt like she needed to vomit, but she did not. The patient states that on Sunday, she still had the chills a little, and the top part of her stomach was still burning. The patient took some Pepto-Bismol and that helped calm down the caller's stomach. The patient stated that she could feel the Pepto-Bismol cooling her stomach off, like it had been hot, and patient stated that the top of her stomach felt swollen and gassy. The patient stated that later Sunday night, things calmed down, but she still has the burning sensation and she did not feel like she needed to vomit anymore. This morning, patient reported that she still has some burning sensation, but now, it is coming and going like labor pains. The patient stated that she did go to the bathroom once this morning and had diarrhea that was like liquid-y water. The patient stated that during all this over the last few days, each and every time that she tried to eat, she couldn't eat much because her stomach would burn more with eating. But yesterday, the patient had some fried fish and stated that the fried fish did not burn as much as the rest of the food she tried eating. The outcome of the events vomiting and the top of her stomach felt swollen and gassy was recovered on 27Dec2020, arm was sore and could not raise her arm was recovered on 26Dec2020, chills, top of her stomach had a bad burning sensation was recovering, Diarrhea/had diarrhea that was like liquid-y water was not recovered and other events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vomiting and Foreign body aspiration cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/01/2020,,UNK,ALBUTEROL [SALBUTAMOL]; SINGULAIR;,Allergy (Caller was diagnosed with allergies in her late 20's.); Asthma (Caller was diagnosed with this in her late 20's.); Blood pressure high (Caller was diagnosed when she was in her 30's.); Type 2 diabetes mellitus (Caller was diagnosed about 10 years ago.),Medical History/Concurrent Conditions: COVID-19,,,"['Abdominal pain upper', 'Chills', 'Choking', 'Cough', 'Diarrhoea', 'Dyspepsia', 'Dyspnoea', 'Flatulence', 'Gastric dilatation', 'Hyperhidrosis', 'Immediate post-injection reaction', 'Injected limb mobility decreased', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Taste disorder', 'Throat clearing', 'Vomiting', 'Weight decreased']",1,PFIZER\BIONTECH, 922382,,,F,"slight elevated heart rate; was white as a ghost; itching; face also swelled; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number and Expiration Date: Not Provided), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Dec2020, the patient experienced: slight elevated heart rate, was white as a ghost, itching, face also swelled; which were all assessed as non-serious. The clinical course was reported as follows: The patient's mother stated that her daughter was a grown woman and did not know that the she was calling Pfizer. The patient's mother stated that her daughter had the COVID vaccine on a Wednesday (as reported), and the patient was kept for 15 minutes after the administration. The patient's mother stated that her daughter had a slightly elevated heart rate, and her daughter's husband said that she was white as a ghost. The patient's mother stated that her daughter also experienced itching, that did require antihistamines. The patient's mother stated that her daughter called the hospital, and they just said that they will make a note of it. The patient's mother stated that as a parent, she was slightly worried about her daughter getting the second dose; however, she was more concerned about her daughter getting COVID. The patient's mother also stated that her daughter's face also swelled after getting the vaccine, but that her daughter did not have any closing of the throat. The patient did have to go to get antihistamines. The patient's doctors did not tell the patient that she needed to pre-medicate with antihistamines next time. The patient underwent lab tests and procedures which included heart rate: slightly elevated in Dec2020. Therapeutic measures were taken as a result of itching. The clinical outcome of the events was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Heart rate', 'Heart rate increased', 'Pallor', 'Pruritus', 'Swelling face']",1,PFIZER\BIONTECH, 922383,LA,35.0,F,"Red itchy rash at injection site; Red itchy rash at injection site; Red itchy rash at injection site; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 5730), intramuscular (left arm) on 22Dec2020 15:15 at single dose for Covid-19 immunization. The patient's medical history included Intracranial HTN (intracranial hypertension) and known allergies: PCN (Penicillin). Concomitant medication included acetazolamide sodium (DIAMOX), topiramate (TOPAMAX), and Multivitamin. The patient previously took Augmentin, tetracycline, and Ceclor and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced red itchy rash at injection site on 26Dec2020. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/26/2020,4.0,PVT,DIAMOX; TOPAMAX,,Medical History/Concurrent Conditions: Intracranial hypertension; Penicillin allergy,,,"['Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site rash']",1,PFIZER\BIONTECH,OT 922384,KS,30.0,F,"swollen lymph node in R armpit. Tender to touch and swollen; swollen lymph node in R armpit. Tender to touch and swollen; This is a spontaneous report from a contactable healthcare professional. A 30-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number 1284), intramuscular on the right arm on 21Dec2020 at 20:30 at a single dose for Covid-19 immunization. Medical history included depression, infertility, and acid reflux. Concomitant medications included omeprazole, fluoxetine hydrochloride (PROZAC), magnesium, and melatonin. The patient previously took trazodone and experienced allergies. The patient experienced swollen lymph node in right (R) armpit, tender to touch and swollen on 26Dec2020. There was no treatment received for the events. The patient was not diagnosed with COVID-19 prior to vaccination and since vaccination has not tested for COVID-19. Outcome of the events was recovering. The reporter assessed the events as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/26/2020,5.0,PVT,; PROZAC; ;,,Medical History/Concurrent Conditions: Acid reflux (esophageal); Depression; Infertility,,,"['Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,OT 922385,IA,39.0,F,"heart rate spiked; difficult to catch breath; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration in the right arm, on 18Dec2020 (at the age of 39-years-old) at a single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis, depression, acid reflux, and COVID-19 (prior to vaccination). The patient has no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications, within two weeks prior to vaccination, included sertraline (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), liothyronine sodium (T3), and levothyroxine sodium (T4). The patient experienced heart rate spiked and difficult to catch breath on 20Dec2020. The events were reported as non-serious. The clinical course was reported as follows: In Dec2020, the heart rate spiked to 194 when running outside and it was difficult to catch breath, so the patient ran/walked the 3 mile route. The heart rate spiked to 183 during a strength training workout and to 148 during a low impact weight training, which is unusual for the patient (as reported). The patient did not receive any treatment for the events. The clinical outcome of heart rate spiked and difficult to catch breath was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/20/2020,2.0,PVT,; ; T3; T4,,Medical History/Concurrent Conditions: Acid reflux (esophageal); COVID-19 (prior to vaccination); Depression; Hashimoto's thyroiditis,,,"['Dyspnoea', 'Heart rate', 'Heart rate increased']",1,PFIZER\BIONTECH, 922386,PA,55.0,F,"Excruciating pain from left deltoid radiating downward to wrist; Left hip pain/Bilateral knee pain; Shivering; Headache; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), intramuscular in the left arm, on 28Dec2020 at 16:30 (at the age of 55-years-old) at a single dose for COVID-19 immunization. Medical history included insomnia, gastrooesophageal reflux disease (GERD), anxiety, mitral valve replacement (MVR) on an unspecified date, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. Concomitant medications, taken within two weeks prior to vaccination, included atenolol (MANUFACTURER UNKNOWN), omeprazole (PRILOSEC), sertraline hydrochloride (ZOLOFT), eszopiclone (LUNESTA), krill oil (MANUFACTURER UNKNOWN), linum usitatissimum oil (FLAXSEED OIL; MANUFACTURER UNKNOWN); ascorbic acid (VITAMIN C; MANUFACTURER UNKNOWN), and calcium (MANUFACTURER UNKNOWN). The patient previously took erythromycin (MANUFACTURER UNKNOWN) and experienced allergy, nitrofurantoin (MACRODANTIN) and experienced allergy, and loracarbef (LORABED) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced excruciating pain from left deltoid radiating downward to wrist, left hip pain/bilateral knee pain, shivering, and headache on 29Dec2020 at 07:00. The events were reported as non-serious. The excruciating pain from left deltoid radiating downward to wrist woke the patient up from her sleep. Therapeutic measures were taken as a result of the events, which included treatment with hydrocodone bitartrate, paracetamol (VICODIN) and heat application. The clinical outcome of excruciating pain from left deltoid radiating downward to wrist, left hip pain/bilateral knee pain, shivering, and headache was recovered with sequel in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,; PRILOSEC [OMEPRAZOLE MAGNESIUM]; ZOLOFT; LUNESTA; ; FLAXSEED OIL [LINUM USITATISSIMUM OIL]; VITAMIN C [ASCORBIC ACID];,,Medical History/Concurrent Conditions: Anxiety; COVID-19 (prior to vaccination); GERD; Insomnia; Mitral valve replacement,,,"['Arthralgia', 'Chills', 'Headache', 'Pain in extremity']",1,PFIZER\BIONTECH,OT 922387,VA,34.0,F,"face puffy; Tingling that started at nose and spread across cheeks and lips; This is a spontaneous report from a contactable healthcare professional. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration in the right arm, on 28Dec2020 at 17:30 (at the age of 34-years-old) at a single dose for COVID-19 immunization. Medical history included sulfonamides allergy. The patient was not pregnant at the time of vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks prior to vaccination, included ascorbic acid (VIT C; MANUFACTURER UNKNOWN), curcuma longa (TURMERIC), and collagen (MANUFACTURER) taken as supplement. Additional concomitant medications included unspecified multivitamin (MANUFACTURER UNKNOWN). The patient previously took azithromycin (MANUFACTURER UNKNOWN) and experienced allergy and vortioxetine hydrobromide (TRINTELLIX) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced tingling that started at nose and spread across cheeks and lips on 28Dec2020 at 18:00 and face puffy on 29Dec2020. The events were reported as non-serious. Therapeutic measures were taken as a result of tingling that started at nose and spread across cheeks and lips, which included treatment with diphenhydramine hydrochloride (BENADRYL). The clinical outcome of tingling that started at nose and spread across cheeks and lips was recovered in Dec2020 and of and face puffy was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,VIT C; TURMERIC [CURCUMA LONGA];,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,"['Paraesthesia', 'Swelling face']",1,PFIZER\BIONTECH, 922388,TX,23.0,F,"Injection site soreness; Headache; Nausea; Body aches; stiffness in neck and shoulder area; Muscle soreness; This is a spontaneous report from a contactable nurse (patient). A 23-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), intramuscularly on 21Dec2020 at 09:00 AM on Left arm at single dose for COVID-19 immunization in hospital. The patient medical history included pre-diabetes, previous liver failure from ciprofloxacin (CIPRO) in 2019, 3 septoplasty due to recurrent sinus infections and nasal cysts in 2016 and 2017. Known allergies included Ciprofloxacin. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included Metformin, Spironolactone, Sertraline. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site soreness, Headache, Nausea, body aches, muscle soreness and stiffness in neck and shoulder area on 22Dec2020 at 02:00 AM. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered with sequel in Dec2020 (also reported as Recovered with lasting effects). The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/22/2020,1.0,PVT,; ;,,Medical History/Concurrent Conditions: Nasal cyst (3 septoplasty due to recurrent sinus infections and nasal cysts in 2016 and 2017); Pre-diabetes; Septoplasty (3 septoplasty due to recurrent sinus infections and nasal cysts in 2016 and 2017); Sinus infection (3 septoplasty due to recurrent sinus infections and nasal cysts in 2016 and 2017),,,"['Headache', 'Musculoskeletal stiffness', 'Myalgia', 'Nausea', 'Pain', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 922389,AZ,,M,"diarrhea; This is a spontaneous report from a contactable nurse (patient's wife). A 73-year-old male patient received bnt162b2 (BNT162B2) at single dose on 28Dec2020 for Covid-19 immunisation, because he was a physician. Medical history included prostate cancer receiving radiation and having bowel issues and diarrhoea. The patient's concomitant medications were not reported. The patient experienced diarrhea in Dec2020 after receiving the vaccine. He had prostate cancer and was receiving radiation so it was normal for him to have diarrhea. The nurse state it was not a good source to confirm if diarrhea is from COVID-19 Vaccine. She has not a chance to talk to her husband about his experiences. The outcome of event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: Bowel discomfort (has prostate cancer and receiving radiation so it is normal to have bowel issues and diarrhoea); Diarrhea (has prostate cancer and receiving radiation so it is normal to have bowel issues and diarrhoea); Prostate cancer (receiving radiation),,,['Diarrhoea'],UNK,PFIZER\BIONTECH, 922390,CA,,F,"Achiness; Runny nose; Sore Arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (friend of patient) reported that a female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown), via an unspecified route of administration on 20Dec2020 once by injection in the left arm at single dose for COVID-19 immunization. The patient medical history included already had COVID last November (unspecified year). No concomitant medications. Reporter confirmed that she spoke with her coworker (patient) who also had a runny nose and achiness, along with a sore arm on 21Dec2020. These only lasted 1-2 days for patient. She was also scheduled to receive the second dose on 10Jan2021. Investigation Assessment was not reported. Therapeutic measures were taken as result of the events included paracetamol (TYLENOL) and dextromethorphan hydrobromide; guaifenesin; paracetamol; pseudoephedrine hydrochloride (DAYQUIL). The outcome of the events was recovered in Dec2020. Information on the lot/batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/21/2020,1.0,UNK,,,Medical History/Concurrent Conditions: COVID-19 (Her friend already had COVID last November.),,,"['Pain', 'Pain in extremity', 'Rhinorrhoea']",1,PFIZER\BIONTECH, 922391,MI,,F,"Swelling on my face around my side of my nose and same on both sides; This is a spontaneous report from a contactable other hcp (patient). This 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the right arm on 29Dec2020 12:00pm for Covid-19 immunisation. Medical history included asthma, eggs chicken penicillin. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), omeprazole (PROTONIX [OMEPRAZOLE]), budesonide, formoterol fumarate (SYMBICORT). The patient stated that experienced: swelling on my face around my side of my nose and same on both sides on 29Dec2020 21:00 with outcome of unknown. No treatment required. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 post the vaccination. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,WELLBUTRIN; PROTONIX [OMEPRAZOLE]; SYMBICORT,,Medical History/Concurrent Conditions: Allergic to birds; Asthma; Egg allergy; Penicillin allergy,,,['Swelling face'],1,PFIZER\BIONTECH, 922392,,,M,"still not feeling well; I feel a little run down; little of bit congestion; This is a spontaneous report from a contactable Other HCP (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported he felt a little run down and little of bit congestion and asked 'if he is still not feeling well should he get the second dose'. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/01/2020,,UNK,,,,,,"['Fatigue', 'Malaise', 'Nasal congestion']",1,PFIZER\BIONTECH, 922393,CA,58.0,F,"Initial reaction: rash on chest; muscle, joint pain; muscle, joint pain; urge to run; inability to sleep; Irritable mood; Muscle spasms; dry eyes; Dry mouth; brain fog, inability to multitask; This is a spontaneous report from a contactable nurse. A 58-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number: EJ1685; intramuscular in left arm on 18Dec2020 at 14:45 (at the age of 58 years-old) as a single dose for COVID-19 immunization. The vaccine was given in a hospital. The patient did not receive any other vaccines in the past 4 weeks. Medical history included asthma, mitral valve prolapse and an allergy to latex. Concomitant medication included calcium (CALCIUM), metoprolol (METOPROLOL), magnesium (MG [MAGNESIUM]), ergocalciferol (VIT D). The patient previously took penicillin and experienced an allergy. The patient did not receive any other vaccines in the past 4 weeks. She did take other medications (concomitant) in the past 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. In Dec2020, at 14:45, the patient experienced rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth, brain fog, and an inability to multitask after 1 week following COVID-19 vaccine. The patient was not hospitalized for the events and no treatment was administered. The outcome of the events: rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth. brain fog, inability to multitask, was recovering. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/01/2020,,PVT,; ; MG [MAGNESIUM]; VIT D,,Medical History/Concurrent Conditions: Asthma; Latex allergy; Mitral valve prolapse,,,"['Arthralgia', 'Dry eye', 'Dry mouth', 'Energy increased', 'Irritability', 'Muscle spasms', 'Myalgia', 'Rash', 'Sleep disorder', 'Thinking abnormal']",1,PFIZER\BIONTECH,OT 922394,MN,28.0,F,"Arm sore/upper arm sore; itching surrounding vaccine site; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1686, via an unspecified route of administration in the right arm on 30Dec2020 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history included an allergy to tegaderm. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), naproxen, zinc, methocarbamol (ROBAXIN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took chlorhexidine and experience allergies. On 30Dec2020 at 21:30, the patient experienced arm sore/upper arm sore, itching surrounding vaccine site. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the arm sore/upper arm sore, itching surrounding vaccine site was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,TYLENOL; ; ; ROBAXIN,,Medical History/Concurrent Conditions: Drug allergy,,,"['Pain in extremity', 'Vaccination site pruritus']",1,PFIZER\BIONTECH, 922395,MI,23.0,F,"Arm more sore than with flu shot; Woke up very nauseous; light headed; achy; Threw up twice; This is a spontaneous report from a contactable healthcare professional (the patient). A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm on 30Dec2020 at 19:15 (at the age of 23-years-old) as a single dose for COVID-19 immunization. Medical history included asthma and peanut allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: montelukast sodium (SINGULAIR), fluticasone propionate/salmeterol xinafoate (ADVAIR), cetirizine hydrochloride (ZYRTEC), all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 31Dec2020 at 05:00, the patient experienced arm more sore than with flu shot, woke up very nauseous, light headed, achy, and threw up twice. No treatment was given for these events. The clinical outcome of arm more sore than with flu shot, woke up very nauseous, light headed, achy, and threw up twice was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,SINGULAIR; ADVAIR; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Asthma; Peanut allergy,,,"['Dizziness', 'Nausea', 'Pain', 'Vaccination site pain', 'Vomiting']",1,PFIZER\BIONTECH,OT 922396,,53.0,F,"loss of her sense of taste and smell; loss of her sense of taste and smell; This is a spontaneous report from a contactable nurse (patient herself). A 53-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Since 29Dec2020, the patient had a loss of her sense of taste and smell that was unresolved. The patient wanted to know if this was a known side effect. The patient was not recovered from the events. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,UNK,,,,,,"['Ageusia', 'Anosmia']",1,PFIZER\BIONTECH, 922397,MI,34.0,F,"Bilateral numbness and tingling on entire body; Bilateral numbness and tingling on entire body; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection in the left arm on 30Dec2020 at 17:30 (at the age of 34-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included multiple sclerosis. Concomitant medications included fingolimod hydrochloride (GILENYA) and vitamin D3. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 30Dec2020 at 18:00, the patient experienced bilateral numbness and tingling on entire body. It was unknown if treatment was provided for events bilateral numbness and tingling on entire body. The outcome of the events bilateral numbness and tingling on entire body was not recovered. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,GILENYA; VITAMIN D3,,Medical History/Concurrent Conditions: Multiple sclerosis,,,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH, 922398,MI,48.0,F,"severe vertigo with headache; severe vertigo with headache; nausea; vomiting; This is a spontaneous report from a contactable health care professional nurse, the patient. A 48-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730, intramuscular in the left arm on 18Dec2020 15:00 as a single dose, for COVID-19 immunization. Medical history included Ongoing Hypertension and Migraines. Concomitant medication included hydrochlorothiazide, losartan potassium (LOSARTAN/HCT) 100/25 daily. The patient had no known allergies. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 29Dec2020 06:00, the patient experienced severe vertigo with headache, nausea and vomiting. The events severe vertigo with headache, nausea and vomiting occurred on Dec 29 and Dec 30, lasted 2 days. Treatment given for severe vertigo with headache, nausea and vomiting was over the counter 'antivert/meclizine'. The clinical outcome of severe vertigo with headache, nausea and vomiting was recovered on Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/29/2020,11.0,WRK,LOSARTAN/HCT,"Hypertension (Hypertension, Migraines)","Medical History/Concurrent Conditions: Migraine (Hypertension, Migraines)",,,"['Headache', 'Nausea', 'Vertigo', 'Vomiting']",1,PFIZER\BIONTECH,OT 922399,MS,44.0,F,"Headache; Low grade fever - 99.3; Shaky and jittery feeling that kept me from sleeping soundly; Shaky and jittery feeling that kept me from sleeping soundly; Shaky and jittery feeling that kept me from sleeping soundly; This is a spontaneous report from a contactable Healthcare Professional reporting for a patient. A 44-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730), intramuscular in the left arm on 30Dec2020 at 09:00 as a single dose, for COVID-19 immunisation. The patient had no known medical history or allergies. Concomitant medication included rosuvastatin calcium (CRESTOR). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 30Dec2020 at 2300, the patient experienced Headache, Low grade fever - 99.3, Shaky and jittery feeling that kept me from sleeping soundly. No treatment was given for the events. The clinical outcome of Headache, Low grade fever - 99.3, Shaky and jittery feeling that kept me from sleeping soundly was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,CRESTOR,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Body temperature', 'Feeling jittery', 'Headache', 'Insomnia', 'Nervousness', 'Pyrexia']",1,PFIZER\BIONTECH,OT 922400,,61.0,F,"couldn't lift my head off my pillow; severe pain in neck; squeezing on a nerve; had soreness in my arm; This is a spontaneous report from a contactable nurse, the patient. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 (at the age of 61 years old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 18Dec2020, the patient experienced soreness in her arm that was gone by the next day. On 23Dec2020, while driving home, she felt severe pain in neck. She almost felt like something went up in her neck and started squeezing on a nerve. It proceeded to get bad so she took muscle relaxants. Christmas day was horrible, she couldn't lift her head off her pillow. The pain came from up head, under her clavicle and down her back. Her pain started getting better, but then next morning it up started again. The only way she's able to get some sleep is to take Flexeril, 800mg of Motrin and applying moist heat. The clinical outcome of severe pain in neck, squeezing on a nerve, couldn't lift her head off her pillow was unknown, and for event had soreness in her arm was recovered on 19Dec2020. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,UNK,,,,,,"['Headache', 'Neck pain', 'Nerve compression', 'Vaccination site pain']",1,PFIZER\BIONTECH, 922401,NY,34.0,M,"Productive cough; Swollen lymph nodes on neck; Severe body aches; Chills; Minor headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: Ek5730, via an unspecified route of administration on 29Dec2020 at 13:30 (at the age of 34 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included fibromyalgia, anxiety disorder, and allergy to amoxicillin from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included omeprazole 40mg and duloxetine 120 mg, both for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 29Dec2020 at 18:30, the patient experienced severe body aches, chills, minor headache, and swollen lymph nodes on neck. On 30Dec2020, the patient experienced productive cough. The patient did not receive treatment for the events. The clinical outcome of body aches, chills, minor headache, swollen lymph nodes on neck, and productive cough was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,;,,Medical History/Concurrent Conditions: Anxiety disorder; Fibromyalgia,,,"['Chills', 'Headache', 'Lymphadenopathy', 'Pain', 'Productive cough']",1,PFIZER\BIONTECH, 922407,KY,64.0,F,HEADACHE FATIGUE AND CHILLS,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,atenolol 50 mg Metformin HCL 500MG,,,,,"['Chills', 'Fatigue', 'Headache']",UNK,MODERNA,SYR 922408,MI,28.0,M,"Arm pain, muscle aches, headache, chills. Started with arm pain a 6 hours after shot. Developed rest of symptoms overnight.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Propranolol 30mg qhs, vitamin D3 25 mcg qday, melatonin 1mg qhs, Zyrtec 10mg qday prn.",,Migraines Childhood asthma Overweight,"Covid vaccine, 12/15/20, muscle aches, chills, headache, nausea",Pollen/seasonal allergies. None to food or medications.,"['Chills', 'Headache', 'Myalgia', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 922409,PA,61.0,M,"Headaches, severe vertigo, vomiting, tired, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,PVT,"Loser tan, daily vitamins",None,None,"When I went into the service, Oct 77, only time",None,"['Chills', 'Fatigue', 'Headache', 'Vertigo', 'Vomiting']",1,PFIZER\BIONTECH,SYR 922410,PA,46.0,F,"Injection site is red, swollen, warm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/04/2021,8.0,PVT,Xeljanz 5mg x 2 daily Levothyroxine 125mcg x 1 daily,,Ulcerative colitis Eczema,,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 922411,MS,53.0,F,"Fever 101.9 , Headache, Body aches, Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PUB,"Omeprazole DR 40mg, 1 daily buPropion HCL XL 300mg, 1 daily Metoprolol Succ ER 50mg, 1 daily Methylphenidate ER 54mg, 1 daily Melatonin otc 3mg, nightly as needed Diclofenac Sod DR 75mg, only as needed Cyanocobalamin 1000mcg/ml, once every",None,Acid Reflux Depression Heart Rhythm Low B-12 Anxiety,,None,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,SYR 922412,FL,51.0,M,Myalgias Headache Arthralgias,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Arthralgia', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH,IM 922414,OH,56.0,F,"uncontrollable chills, headache, fatigue, body aches, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain']",UNK,MODERNA, 922415,GA,24.0,M,"Terrible chills, body aches, fever 101.9 , HA , nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2020,01/04/2020,0.0,PVT,none,none,none,,none,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 922416,MI,48.0,F,"Patient states arm which vaccination was given became red and sore 3 days after vaccination. It them became large, softball size, red, hot, swollen, and itchy. She states it lasted 10 days and is now resolving with bactroban ointment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/25/2020,3.0,PVT,Unknown,Unknown,Unknown,,No known allergies,"['Erythema', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Skin warm']",1,MODERNA,IM 922417,,38.0,F,"Left arm deltoid sore at injection site, tiredness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,MIL,"Multivitams, l-lysine, thermogenic, CLA, whey protein",None,"Anxiety, PTSD, depression",,Kiwi,"['Fatigue', 'Injection site pain']",1,MODERNA,SYR 922418,IN,34.0,F,"Nausea, tachycardia and elevated blood pressure. O2 at 100%, BP at 167/114 pulse 135 patient resolved within 10 minutes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Patient became nauseas, elevated BP and tachycardic. O2 100%, Pulse 135 BP 167/114 Brand moderna lot 039K20A",,,,,"['Blood pressure increased', 'Nausea', 'Tachycardia']",1,MODERNA,IM 922419,PR,38.0,F,"pain all over the body, swelling of neck, axilla and arm, pain on left side of arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,WRK,Lisinopril 10mg,Hypertension,no,,Aspirin,"['Lymphadenopathy', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Swelling']",2,PFIZER\BIONTECH,IM 922420,NJ,53.0,M,SEVERE HEADACHES LASTING A FEW HOURS AND ACUTE PAIN IN ARM WITH FROZEN SHOULDER UNABLE TO LIFT ARM,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,NONE,UC,NO,,CIPRO:KEFLEX: IODINE,"['Headache', 'Joint range of motion decreased', 'Pain in extremity', 'Periarthritis']",1,MODERNA,IM 922421,MA,47.0,F,Moderna COVID-19 Vaccine EUA - rash at injection site one week post-injection in left upper arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,WRK,"levothyroxine, fish oil supplements, Calcium/magnesium supplements, vitamin E, vitamin D, vitamin C, 1x day multi vitamin, zyrtec",none,none,,sulfa,['Injection site rash'],1,MODERNA,IM 922422,CT,68.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,,,PVT,"Lisinopril 10mg, zinc Vit D, Multi vit,",,,,,['Unevaluable event'],2,PFIZER\BIONTECH,SYR 922423,,25.0,F,"Right arm soreness, Stomach bug and exhaustion for 3 days after the 1st dose of the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,MIL,"Ibuprofen, Zoloft, Trazodone, Ribloflavin, etc",Migraines,Chronic hip pain,,NKA except seasonal,"['Abdominal discomfort', 'Fatigue', 'Pain in extremity']",1,MODERNA,SYR 922424,ME,44.0,F,"Woke up with a golf ball sized bullseye, swollen, red, itchy, sore, and hot to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/04/2021,9.0,WRK,"Tramadol, Excedrin, Flonase",,Fibromyalgia,,NKA,"['Abnormal sensation in eye', 'Eye pain', 'Eye pruritus', 'Eye swelling', 'Ocular hyperaemia']",1,MODERNA,IM 922425,OH,34.0,F,itching and rash,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,OTH,Levothyroxine MVI,No,Thyroid,,Nabumetone and Keflex,"['Pruritus', 'Rash']",1,MODERNA,IM 922426,AL,67.0,M,"Three days 1st dose of Pfizer vaccine I developed moderate headache and malaise. Six days later I developed a maculo-vesicular itchy, non painful rash on my R forehead. I visited an Immediate Care office (started valacyclovir) and I was seen the same day by a retina specialist ophthalmologist (started prednisone 60 mg/day). I'm doing much better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/19/2020,3.0,PVT,None,None,Heart arrhythmia prosthetic vanlve replacement,,PCN,"['Headache', 'Malaise', 'Ophthalmological examination', 'Physical examination', 'Rash', 'Rash maculovesicular', 'Rash pruritic']",UNK,PFIZER\BIONTECH,IM 922427,KY,50.0,F,"Redness, swelling, induration, painful to the touch, hot to the touch and itching. Has lasted for over 1 week since vaccine administered. Applied heat and ice. Improved some with moist heat but resumed shortly after treatment. Does not interfere with arm use at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,WRK,None,None,Hypertension,,Percodan,"['Erythema', 'Induration', 'Pruritus', 'Swelling', 'Tenderness']",1,MODERNA,IM 922428,NY,32.0,F,"Slight arm soreness about 12 hours after injection, with severe rigors shortly thereafter. Fever to 101.8 and uncontrollable shaking/chills, and moderate to severe headache. Rigors lasted about 6 hours, headache persists.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Lexapro,None,None,,None,"['Chills', 'Headache', 'Pain in extremity', 'Pyrexia', 'Tremor']",2,PFIZER\BIONTECH,SYR 922429,MO,33.0,F,"Body aches, fever over 100.4, joint pain, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,WRK,"Lisinopril, 10mg Levoxyl, 300mg Prozac, 40mg",N/a,Hypothyroidism Depression Hypertension,,Sulfa medicine,"['Arthralgia', 'Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 922430,,29.0,F,"Experienced minor chills about 11 hours post vaccination (7:00pm) and took 1000mg acetaminophen and went to bed at 9:30pm. Woke at 11:30pm with uncontrollable chills, nausea, headache and muscle spasms (shaking). Took 1000mg acetaminophen and was able to get back to bed at 2:30am. Had a vivid/stressful dream ongoing off and on all night about completing a task I couldn?t understand, was irrational, and completion would lead to the symptoms subsiding. Woke back up at 4:00am with chills and shakes and a headache and took another dose of acetaminophen. Relaxed at 5:00am and got out of bed. Took 600mg ibuprofen for significantly sore injection site that feels very deep and even goes into the arm pit.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,MIL,1000mg acetaminophen 30 mins prior to vaccine,,,,,"['Abnormal dreams', 'Axillary pain', 'Chills', 'Headache', 'Injection site pain', 'Muscle spasms', 'Nausea', 'Thinking abnormal', 'Tremor']",2,PFIZER\BIONTECH,IM 922431,FL,47.0,F,"Itching, redness , bruising ,raised area at site of injection that was one week delayed",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Birth Control, Lavender Tea, Hibiscus Tea, Goji Berry Tea, Mint/green Tea",NONE,NONE,,"NKDA, NKFA, NKA","['Injection site bruising', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 922432,NY,49.0,F,"After receiving the injection in the right arm, the patient began to feel pain and burning at the injection site in the right deltoid with spreading down to her hand along with localized redness at the injection site. She was given 50 mg of diphenhydramine and subsequently developed facial flushing and a feeling of numbness/tingling in both arms and hands. At this time, about half an hour had elapsed after the injection, so she was referred to the hospital emergency department from the hospital vaccine pod for additional monitoring. No additional interventions were given in the emergency department, she was discharged home after 3 hours of monitoring. Symptoms had improved with time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,None reported,None reported,Denies any chronic health condition,,NKA,"['Flushing', 'Hypoaesthesia', 'Injection site erythema', 'Injection site pain', 'Pain in extremity', 'Paraesthesia', 'Skin burning sensation']",1,PFIZER\BIONTECH,IM 922433,PR,33.0,F,Tacycardia (HR 145) and SOB,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,"Prolaire, Duoneb, Claritin, Zyrtec, Topiramate, Butalbital, Multi-vit w/iron,",Chronic bronchitis flair-up,"Chronic bronchitis, Asthma, Migrains, PCLS",,Sulfa drugs,"['Chest X-ray normal', 'Dyspnoea', 'Electrocardiogram normal', 'Tachycardia', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 922434,,39.0,F,"temp 99.5, fatigue, body aches, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,WRK,,,,,,"['Body temperature increased', 'Fatigue', 'Headache', 'Pain']",UNK,PFIZER\BIONTECH, 922435,OH,50.0,F,Shortness of breath and elevated heart rate,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,"Vit. D 2500 units, protonix 40 mg daily; zinc 220mg daily, Vitamin C 500 mg daily",None,Diverticulitis and Acid Reflux,,Morphine and Dilaudid,"['Dyspnoea', 'Heart rate increased']",1,MODERNA,IM 922436,,,F,2hrs after the vaccination -slight headache and nauseated Noticed the redness/ stiffness of the area 1/01/2021 and lasted 3days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,Hypertension/diabetes,,,"Aspirin, contact allergy","['Erythema', 'Headache', 'Musculoskeletal stiffness', 'Nausea']",UNK,PFIZER\BIONTECH, 922437,LA,40.0,F,"Tingling in fingers Fingers contracting without pain, only tingling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,WRK,"Vitamins B-12 9Injection and by month), C, D, B1 Iron, Multi Vitamin",,,,Morphine,"['Extremity contracture', 'Paraesthesia']",1,PFIZER\BIONTECH,SYR 922438,GA,57.0,F,Nosebleed,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,Nadolol(migraine mgmt),None,Migraines,,"Mushroom, Cherries, Morphine, Bactrim",['Epistaxis'],1,PFIZER\BIONTECH,IM 922439,MA,51.0,M,"Client reported mild itching in left arm approximately 10 minutes after receiving vaccine. No shortness of breath noted, alert and oriented with no known drug allergies and no history of anaphylaxis. Vital signs taken at 0705 reported as: BP 138/83, P 65 bpm, O2 99% on room air, temp 98.0 degrees Fahrenheit, all within normal limits reported from client. Stayed for 15 minutes longer and reported subsiding of itching in arm. Client discharged from area.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,Glaucoma,,NKA,['Pruritus'],1,MODERNA,IM 922440,MD,34.0,F,"At the time of injection, patient felt pain and a ""zinger"" at the injection site that traveled up into the left shoulder and down the left arm. A numbness and tingling sensation has continued in the left arm and then all over the body- bilateral upper and lower extremities intermittently since time of injection until current. The sensations are occurring randomly about every 1 minute. No associated muscle weakness or any other neurological changes. Patient has been referred to a neurologist for further evaluation and management.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/19/2020,0.0,PVT,,None known,None known,,None known,"['Full blood count', 'Hypoaesthesia', 'Injection site pain', 'Magnetic resonance imaging spinal', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Vitamin B12']",1,PFIZER\BIONTECH,IM 922441,MD,63.0,F,"Fever, chills, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/06/2021,5.0,PUB,"Amlodipine, atorvastatin, cefuroxime",,,,,"['Chills', 'Nausea', 'Pyrexia']",UNK,MODERNA,SYR 922442,MA,33.0,F,A rash appeared at the injection site a week after receiving the injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2000,01/06/2021,7314.0,PVT,Claritin and birth control,None,None,,None known,['Injection site rash'],1,MODERNA, 922443,GA,32.0,F,"Vaccine administered on 12/29, severe burning while injecting and for 5-10 seconds after injecting. 12/30 noticed lesion on upper arm in area of injection- erythematous, warm, pruritic, raised area, about 4x4cm. No change until 1/5. 1/5: 7.5x4cm lesion, increased pruritus, warm, erythematic, and 3-5 pin-head sized vesicles with clear exudate formed on the medial side of lesion. Pregnancy history- 4 pregnancies in past 12 months with no live births. 2 miscarriages and 1 ectopic. LMP 12/12/20, patient was pregnant at time of injection but unaware.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"Prenatal Vitamins, CoQ10, Florastor probiotic, Vancomyacin, zyrtec",C. Diff,None,,Shellfish,"['Burning sensation', 'Exposure during pregnancy', 'Immediate post-injection reaction', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site vesicles', 'Injection site warmth']",UNK,MODERNA,IM 922444,CA,44.0,F,increased frequency of known recurrent syncope,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/03/2021,5.0,WRK,Midodrine Lysteda Levothyroxine Ivabradine,syncope,"Hypothyroidism, Vasovagal Syncope, GERD, Uterine fibroids, H. Pylori Infection, AV node ablation, Endometriosis, Iron Deficiency Anemia",,Reglan,"['Angiogram', 'Electrocardiogram', 'Fibrin D dimer', 'Full blood count', 'Syncope', 'Toxicologic test', 'Urine analysis']",UNK,PFIZER\BIONTECH, 922446,ME,36.0,F,"Redness, swelling, and pruritus at injection site 1 week post vaccine. Lymphadenopathy developed shortly after injection site reaction, starting in right axilla. Lymphadenopathy has extended up right side of neck and posterior right skull, as well as down right rib cage. Patient was also lightheaded and dizzy. Conservative treatment to this point, including topical as well as oral benadryl, ibuprofen, and acetaminophen. As of the writing of this description, symptoms are ongoing without any response to treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,PVT,None,None,None,,Allergy to Penicillin and Sulfa antibiotics,"['Dizziness', 'Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Lymphadenopathy', 'SARS-CoV-2 test']",1,MODERNA,IM 922447,OH,34.0,F,"Swollen neck, head ""heavy"" dizzy, thick tongue, flushed red rash to neck and chest.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,"Zofran, protonix",,,,adhesive and latex,"['Dizziness', 'Flushing', 'Head discomfort', 'Rash', 'Rash erythematous', 'Swelling', 'Tongue disorder']",1,MODERNA,IM 922448,VA,27.0,M,"chills, fatigue, high arm pain, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PUB,,,,,,"['Chills', 'Fatigue', 'Nausea', 'Pain in extremity']",1,MODERNA, 922449,VA,24.0,F,"I developed a red painful rash almost that had heat coming off of it, I asked one of the Doctors at work to take a look at it and she determined that it was cellulitis. She told me to report my side effect to the CDC.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,Paxil 20mg omeprazole Fexofenadine,None,Depression and Anxiety Seasonal allergies,,NKA,"['Cellulitis', 'Rash', 'Rash erythematous', 'Skin warm']",UNK,MODERNA,SYR 922450,OH,44.0,F,"I developed warmth, redness, and itching at the injection site 10 days after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,01/04/2021,9.0,UNK,Paxil,None,Finished chemotherapy 4/2020 for Ovarian Cancer. Currently in remission,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 922451,PA,62.0,F,Congestion and low grade fever. Generally not feeling well,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Malaise', 'Pyrexia', 'Respiratory tract congestion']",1,MODERNA,IM 922452,OH,25.0,F,"On 1/5/2021, a week after receiving the vaccine, a 2cmx3cm hive appeared at the injection site (rt deltoid). Raised, warm to touch, itchy. at time of reporting, approx 12 hrs later, there is minimal improvement. Took 1 benadryl at 2330 on 1/5. Mild discomfort and tingling throughout triceps on rt arm. I did not experience any side effects other than injection site soreness for 72 hrs after receiving the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/05/2021,7.0,WRK,Topamax - 50mg 1xdaily,None,"Migraines w/aura, Asthma",,"Cefzil, nystatin","['Injection site pain', 'Injection site urticaria', 'Limb discomfort', 'Paraesthesia', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,IM 922453,MA,31.0,F,"Injfection site still red, warm to touch , 9 days after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,UNK,metformin effexor,none,PCOS,,none,"['Injection site erythema', 'Injection site warmth']",UNK,MODERNA, 922454,PA,35.0,F,She experienced a rash and a low grade fever,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Pyrexia', 'Rash']",1,MODERNA,IM 922455,NJ,65.0,F,"patient's ear's turned red post vaccination. she also reported itchy sensation. she was monitored for 30 minutes post vaccination and did not received any medical treatment, was sent home and advised to seek medical care if symptoms worsened.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,not known,not known,not known,,"methylprednisolone, penicillin, sulfa","['Erythema', 'Pruritus']",1,MODERNA,IM 922456,NY,57.0,F,Patient reported a tingling sensation going down left arm and leg. VS were taken and patient was told to practice deep breathing and drink water. Resolved after 30 minutes,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,Seafood,['Paraesthesia'],1,MODERNA,IM 922457,MD,28.0,F,"Arm was sore immediately, became extremely sore by 6AM the next morning Muscle aches, general feeling of unwellness, malaise/fatigue started at 6AM the next morning Minor headache at 6AM the next morning",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,OTH,Adderall XR 20 mg,None,"Crohn's disease, ADHD",,Penicillin,"['Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Pain in extremity']",1,MODERNA,IM 922458,LA,66.0,M,"Absolutely no problems after the vaccination until about 24 hours later: Then sudden onset malaise, fever, myalgias (including injection site pain which was not previously present) arthralgias, headache, nausea, malaise to the point where I could not continue to work. I went home, took 600 mg ibuprofen, 25 mg of benadryl and slept for 4 hours. I felt better when I woke up and feel good today, as if nothing happened",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"ASA 81/d Atorvastatin 40/d eyedrops: Timolol, Kertolac, Prednisolone",None,"COVID 19 infection March 2020, severe with subsequent L retinal vein thrombosis, partial loss of gag reflex and left foot clumsiness Prostate cancer s/p prostatectomy",Left arm weakness after thimersol containing vaccines in the 1980s,Thimersol,"['Arthralgia', 'Headache', 'Impaired work ability', 'Injection site pain', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,IM 922459,KY,65.0,F,The day following the injection of the vaccine work up with nose running and had a fever up to 102 degrees.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,Zoloft,Had Covid 11/15/20 - 12/17/20,Sleep apnea,,Cefador - antibiotic,"['Pyrexia', 'Rhinorrhoea']",1,MODERNA,IM 922460,FL,32.0,M,"Chills, Body aches, Cough",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,MIL,"Flonase, Allegra, MV, Vit D supplement","Gastroenteritis, URI (not Flu or COVID based on negative lab results)","Allergic rhinitis, Vit D deficiency",,NKDA,"['Chills', 'Cough', 'Pain']",1,PFIZER\BIONTECH,IM 922461,,23.0,M,Moderna COVID-19 Vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,MIL,,,,,,['Unevaluable event'],1,MODERNA,IM 922462,VA,41.0,F,"pain at injection site, muscle weakness, aching muscles, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,"Wellbutrin, fluoexetine, seriously, Tylenol arthritis",none,Hypertension Depression Anxiety,,NKDA/ NKA,"['Fatigue', 'Injection site pain', 'Muscular weakness']",1,MODERNA,IM 922463,MI,53.0,F,"Eight days after receiving vaccination deltoid muscle at and below injection site became red, tender, warm and indurated. Possible activating factor was taking a hot bath.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,WRK,"Tumeric, collagen, vitamin A, B, D, omega 3, estrogen patch",None,None,,None,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 922464,SC,38.0,F,A couple minutes after injection I felt flush over my chest area. It lasted about 30 seconds then my heart started racing. My iwatch heartrate notified me that my heart rate was 162. This lasted for about 7 minutes. My throat felt a little scratchy but not to where I had anaphylaxis reaction to seafood.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Synthroid and Effexor,none,hypothyroidism,,"Penicillin, Seafood","['Flushing', 'Immediate post-injection reaction', 'Palpitations', 'Throat irritation']",UNK,PFIZER\BIONTECH,IM 922465,FL,29.0,F,"Myalgia, chills, headache starting 1/6/2021 at 6 am Local pain and swelling starting 2 hours post vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Venlafaxine ER 75mg daily,None,GERD Depression OCD,,NONE,"['Chills', 'Headache', 'Myalgia', 'Pain', 'Swelling']",2,PFIZER\BIONTECH,IM 922466,NY,44.0,F,"Patient reported tinnitus post vaccination, denied dizziness or lightheadedness. Drank water and was observed, after 15 minutes felt better and was discharged",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Junel 1.5/30 mg/mcg,,"hypertension, diabetes, anemia & asthma",,No Known,['Tinnitus'],1,MODERNA,IM 922467,IN,60.0,F,"INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINESS, TIREDNESS, MUSCLE PAIN, CHILLS ALL BY 13:30PM AND LASTED FROM 1.04.21 AND CURRENTLY ON 1.06.21 STILL TIRED, DIZZY, HEADACHE, CHILLS AND ITCHY BUT IS BETTER THAN ON 1.04.21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"OMEPRAZOLE DR 20 MG CAPSULE 1 TIME A DAY, ADVAIR 250-50 DISKUS BLISTER WITH DEVICE 1 PUFF TWICE A DAY, ALLOPURINOL 300 MG TABLET 1 TIME AT BED TIME, HYDRALAZINE 50 MG TABLET 2 TABLETS TWICE A DAY, MOMETASONE FUROATE 50 MCG SPRAY 1 SPRAY T","HBP,GOUTE, LOW POTASSIUM, ACID REFLUX, ALLERGIES, ASTHMA","ASTHMA, ALLERGIES, HBP, ACID REFLUX",,"CODEINE, ASPIRNE, SULFER,","['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Heart rate increased', 'Injection site erythema', 'Malaise', 'Myalgia', 'Nausea', 'Pruritus']",1,PFIZER\BIONTECH,SYR 922468,PA,46.0,F,"About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever and some chills, along with body aches. I felt nauseous. I started feeling cramping in my stomach. Yesterday, my temp was just 99.4, face was really red. Felt over heated all day long. When they gave me the shot, after 20 mins I could feel my right nostril burning, and like I could taste a metal taste and taste the actual shot. At 9am, my temp was 100. I took a tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,No,No,No,,No,"['Abdominal pain upper', 'Body temperature increased', 'Burning sensation', 'Chills', 'Dysgeusia', 'Erythema', 'Feeling hot', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 922469,NJ,23.0,F,"Large rash (few cm) started on day 10 of the vaccine administration, woke up to it being red and itchy. It was slightly raised. Over the days the rash faded away and the itchiness faded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/04/2021,9.0,PVT,Multivitamin Vitamin B12 Vitamin B-2 Vitamin D Zinc Supplement Biotin supplement Magnesium supplement NSAIDs as needed for migraines,,Mild asthma/seasonal allergies Migraines,,Seasonal allergies and mild asthma,"['Rash', 'Rash erythematous', 'Rash pruritic', 'Skin swelling']",1,MODERNA,SYR 922470,WA,37.0,F,Diarrhea Sore arm at site of injection 1 day tension headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,WRK,Propranolol,no,migraine with aura,"TDAP, 10, 20, 30 years old, sore arm",no,"['Diarrhoea', 'Injection site pain', 'Tension headache']",1,PFIZER\BIONTECH,IM 922471,NY,38.0,F,Severe left axilla pain started 5 days after shot given,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,WRK,"Venlafaxine XR 150 mg, Cetirizine 10 mg, Excedrin Migraine",none,Migraines,,Betadine,['Axillary pain'],1,MODERNA,SYR 922473,GA,38.0,F,"Chills, shivering, body aches, joint aches , treated with Motrin with improved symtpoms",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,none,none,none,,Penicillin,"['Arthralgia', 'Chills', 'Pain']",2,PFIZER\BIONTECH,IM 922474,FL,31.0,F,Swollen Lymph Node above left clavicle.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/31/2020,30.0,UNK,Multi-Vitamin.,Sinus infection,"Depression, Chronic sinus infections, anxiety",,no known allergies,['Lymphadenopathy'],UNK,PFIZER\BIONTECH, 922475,VA,56.0,F,"I was not able to sleep that night for I started having muscle pain, The muscle pain became do bad i was close to tears. Beyond muscle pain I also had joint pain an a headache. Also fatigue and lost of appetite. I continually took Tylenol, Advil and Robitusen Cold and Flu. I am on day 2, still have not eaten. The muscle pain is starting to ease up but not very exhausted.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,Multi Vitamin,none,none,,"Codeine, Hydrocodone","['Arthralgia', 'Decreased appetite', 'Fatigue', 'Headache', 'Myalgia', 'Sleep disorder', 'Tearfulness']",UNK,MODERNA,IM 922476,OH,53.0,F,"Moderna COVID-19 Vaccine EUA: On 12/30/2020, I just had slight tenderness/soreness at the injection site. On 1/5/2021, I noticed tenderness under my left arm pit. On 1/6/2021, I felt itching on my left arm at the injection site--the injection site looks raised, bumpy, and welt-like. On 1/6/2021, I placed Cortisone cream on the injection site and following instructions to report side effects. I will continue to monitor.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/06/2021,8.0,UNK,,,,,,"['Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site reaction', 'Injection site swelling', 'Lymph node pain', 'Urticaria']",1,MODERNA,SYR 922477,FL,72.0,F,Bumps on sides of tongue first than on the top. Dry throat,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Avapro, advil",none,None,flu shot,Slight allergy to strawberries and nuts,"['Dry throat', 'Tongue disorder']",1,MODERNA,SYR 922478,MA,51.0,F,"Started with fever of >101, body aches, chills, headache around 1am. Fever relieved with Tylenol at 7am. Body aches lessened, chills continued, headache lessened. Started again with fever, body aches, chills around 4pm. Took Tylenol again. Symptoms lessened. Felt better following morning, symptoms resided. Also very sore upper left arm x4 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Methimazole 5mg, Atenolol 25mg, Multivitamin, Calcium 500mg",,Grave's disease,,none,"['Chills', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 922479,WA,32.0,M,"ON 1/6/2021 HAD EPISODE OF EMESIS THAT WAS BACK TO BACK X3 WITH ZERO TOLERANCE OF ANYTHING ORAL. NOT SURE IF IT IS RELATED, BUT I THOUGHT I WOULD REPORT IT. ALSO ASSOCIATED WITH NAUSEA, PALPITATIONS, SWEATS FOLLOWED BY EMESIS. UNRESPONSIVE TO ZOFRAN 4MG X2 2 HOURS APART.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,01/06/2021,16.0,OTH,"FLUOXETINE, BUPROPRION XL, VYVANSE, VICTOZA, JARDIANCE, METFORMIN, ALEVE, LEVOTHYROXINE, XYZAL, FLONASE",NONE,"T2DM, HISTORY OF NASOPHARYNGEAL CARCINOMA, DEPRESSION, ANXIETY, ADHD, OBESITY, VITAMIN D DEFICIENCY, ENVIRONMENTAL ALLERGIES, BICUSPID AORTIC VALVE, OSTEOARTHRITIS",,"ORAL INTOLERANCE TO FISH, MELON, BANANNA, CUCUMBER DUST, CATS, DOGS AND OTHER ENVIRONMENTAL TRIGGERS","['Feeding disorder', 'Fluid intake reduced', 'Hyperhidrosis', 'Nausea', 'Palpitations', 'Vomiting']",1,PFIZER\BIONTECH,IM 922480,OH,36.0,F,"6 days after the vaccine injection she had a large red, hot area measuring 60-70mm. States area is tender and itches. Advised to use compresses to site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/03/2021,6.0,OTH,Unknown,Unknown,Unknown,,Unknown,"['Erythema', 'Pruritus', 'Skin warm', 'Tenderness']",1,MODERNA,IM 922481,NY,54.0,F,"patient complained of tinnitus post COVID vaccine, VS taken given water and monitored. Resolved after 30 minutes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Flovent, Montelukast, triamcinolone oint.",,asthma,,"eggs, latex",['Tinnitus'],1,MODERNA,IM 922483,FL,36.0,F,"2 weeks post injection. Swelling, red and warm to the touch on/off",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,"Effexor, birth control and Xanax as needed",,,,,"['Erythema', 'Skin warm', 'Swelling']",1,MODERNA,SYR 922484,GA,59.0,F,fever of 101.2 and joint pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"zoloft, folic acid, vitamin C, multi vitamin, and naprosyn 200mg",none,osteoarthritis,,sulfa,"['Arthralgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 922485,FL,37.0,M,"3 days after the shot, 1/3, I started to feel soreness under my tongue. I've felt this before when starting to feel sick. It progressively got worse, appearing to have peaked on 1/5. It is painful all the time, but really hurts to extend my tongue and swallow. While it hurts on both sides, it seems to be worse on the left side. When I lift my tongue and look in the mirror, it looks like the tissue is swollen some on the left. I scheduled a visit with the ARNP at my doctor's office, who I mentioned earlier. She couldn't determine an exact cause. She believed it could possibly be an immune response to the vaccine or something viral. If it gets worse or doesn't go away after a week she asked that I call back. The pain is unresponsive to 400 mg of Ibuprofen. If I take 800 mg I do get some relief, but can definitely still feel it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/03/2021,3.0,PVT,Loratadine 10 mg/day.,None,"Environmental allergies (pretty much all common ones. Pet dander, dust, pollen, etc) Undiagnosed high diastolic blood pressure - from my own observations it can range from 90-100.",,No known,"['Condition aggravated', 'Glossodynia', 'Odynophagia', 'Pain', 'Swollen tongue']",1,MODERNA,IM 922486,NY,30.0,M,"Left sided axillary lymphadenopathy, with self-limiting pain lasting approximately 3 days, and lymphadenopathy persisting.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,PVT,None,None,None,,Sulfa,"['Axillary pain', 'Lymphadenopathy']",1,MODERNA,IM 922487,PA,33.0,F,"Red, raised, itchy 4 inches around injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/31/2020,8.0,PUB,"simvastatin and birth control ; yaz, Vitamin C and B, and D",no,no,,sulfa,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 922488,NY,24.0,F,noticed a small red raised area at vaccine injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,,,,,,['Injection site swelling'],1,MODERNA,IM 922489,VA,58.0,F,"Headache, dizziness, disorientation, upset stomach. Headache not resolved with tylenol. Symptoms resolved after 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/04/2021,6.0,PVT,Triamterence,"Discomfort 1 year post op hip replacement surgery prescribed Methylprednisolone (spelling ?) 6 day steroid early December , 2020.",high blood pressure,"First Flu shot about 10 years ago (approx 48 years old), fever, chills, fatigue; kept me out of work and on the couch for the en",adverse reaction to Statins,"['Abdominal discomfort', 'Disorientation', 'Dizziness', 'Headache']",1,PFIZER\BIONTECH,SYR 922490,NY,56.0,F,Patient stated she had a metallic taste in her mouth post injection. She drank gingerale and the taste subsided,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,calcium + vitamin D,,"anemia, mitral valve regurgitation",,no known allergies,['Dysgeusia'],1,MODERNA,IM 922491,TX,30.0,F,"Rigors (4 hours), Fever to 101F (4 hours), muscle aches, fatigue, headache (ongoing)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,MIL,- Effexor (Venlafaxine) 150mg daily - Propanolol (Inderal) 80mg ER BID,,Depression,,Almonds,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 922492,WV,40.0,F,12/28/20 Patient received Moderna COVID19 vaccine for first injection of 2 shot series. Patient developed right arm sorness later that day. No other symptoms and sorness left within two days. Patient presents today with reddness to right deltoid approx 4-5 cm reddness around where injection was placed. Site is noted to be warmer than surounding tissues. Patient also notes throbing dull ache to site and down arm. Rates pain at 2 -3. Also notes more slower responsiveness of this muscle group when preforming power cleans and working out. No fever noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,PVT,Birth control pill,None,Kidney Stones- chronic but not occuring at time of vaccination,,No known allergies,"['Injection site erythema', 'Injection site reaction', 'Injection site warmth', 'Muscular weakness', 'Pain', 'Pain in extremity']",1,MODERNA,IM 922493,ME,30.0,F,"Day 5 post vaccine - 2100 I woke up with sudden hot flash, increased heart rate and sudden shaking chills. I felt asleep around 0100 the next morning- missed work this day. Went for COVID test (negative) and about 30 minutes post test began feeling weak and faint. Went to Emergency Dept, receive a liter of normal saline. By vital signs I remained orthostatic( hypoxia and tachycardia upon standing) symptoms remained the rest of the day. 1/5- fatigued but other symptoms resolved 1/6- symptoms resolved 100%",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Zinc,vitD, B12",None,None,,Penicillin,"['Asthenia', 'Chills', 'Fatigue', 'Full blood count', 'Heart rate increased', 'Hot flush', 'Hypoxia', 'Impaired work ability', 'Metabolic function test', 'Orthostatic hypotension', 'Pregnancy test urine', 'SARS-CoV-2 test negative', 'Syncope', 'Tachycardia', 'Tremor', 'Urine analysis']",1,MODERNA,IM 922495,,24.0,F,"Moderna COVID-19 Vaccine EUA; On 12/30/2020 I began experiencing soreness in my left arm along with a short period of chills and body aches. The next day, 12/31/2020, I noticed the injection site had a small, thumb-print sized red area around it. It seemed to have faded over the course of the next week however on the morning of 1/4/2021 I noticed soreness under my left arm pit. On 1/6/2021, the redness around the injection site increased and a second, distinct red spot developed on my left arm, close to the injection site. Both spots are raised and hard but not itchy. I put Cortizone cream on both spots and am monitoring its progress.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/31/2020,2.0,UNK,,,,,,"['Axillary pain', 'Chills', 'Injection site erythema', 'Injection site rash', 'Injection site swelling', 'Pain', 'Pain in extremity']",1,MODERNA,SYR 922496,TX,49.0,F,isolated left supraclavicular adenopathy with tenderness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/06/2021,6.0,PVT,"mirapex, vitamin D, flexoril",none,"restless legs, back pain",,phenergan,"['Lymphadenopathy', 'Tenderness']",1,MODERNA,IM 922497,MA,27.0,F,Sore arm for one day. Wrist pain that has persisted for over a week following vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,UNK,"Balziva, proair, symbicort, Singulair, omeprazole, claritin",,Asthma,,N/a,"['Arthralgia', 'Pain in extremity']",1,MODERNA,IM 922498,IN,35.0,F,"Headache noted the night of vaccine and continues to present time. General fatigue noted 1/5/21 with some body aches. Around 4:30pm on 1/5/21 took 1g acetaminophen for headache. At 5pm 1/5/21 temperature of 99.4 noted. By 6pm 1/5/21 temperature was 99.9 (despite acetaminophen in system). Difficulty sleeping 1/5/21 and awoke with intense chills followed a couple hours later with sweats and temp 100.3. Increased sinus congestion also noted, unrelieved by Sudafed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,"Levothyroxine, Allegra, Singulair, Anoro Ellipta, vitamin D, MVI, Sudafed",None,"Hypothyroidism, vocal chord dysfunction",,PCN,"['Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Insomnia', 'Pain', 'Sinus congestion']",2,PFIZER\BIONTECH,IM 922499,UT,55.0,F,"On 12/24/20 through Wed 12/30 daily while exercising; either back country skiing, resort/alpine skiing, Nordic/skate skiing or hiking uphill, I developed rapid onset, severe, debilitating, crippling 8/10 pain in my right fectus femoris thigh muscle. Duration of spasms 1-2 seconds, frequency every 10-15 minutes while exercising up to 6 hours/day. Self treatment included taking Ibuprofen 400 mg tabs po daily, OTC electrolytes po daily, application of topical diclofenac (Voltaren) gel, increase in hydration of non caffeinated/non alcoholic beverages; without any improvement.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/24/2020,3.0,PVT,OTC Multivitamins,None,Seasonal allergies,,Atovaquone/progualil (Malarone),"['Asthenia', 'Disability', 'Muscle spasms', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 922500,MO,47.0,M,"Beyond the sore arm, around midnight the same night as the vaccine, I experienced a 10 minute time period of chills with uncontrollable shivering that persisted until I laid under the covers as still as possible and let it pass. The following day, I felt like I didn't want to do anything and was easily irritable. All symptoms resolved after 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,None,None,None,,None,"['Chills', 'Irritability', 'Pain in extremity']",1,MODERNA,IM 922501,ME,50.0,F,"Pfizer-BioNTech COVID-19 Vaccine: 1/4/21 Started with dull ache pain to left upper tooth, worsened with chewing and eating on left side on day one. Symptoms became worse during the day with electric like pain radiating to the maxilla, TMJ and temple. Symptoms persisted as episodic aching and electrical radicular pain 1/5 so I saw my dentist in the afternoon with a negative work up on exam and xray. Pain worsened and pattern expanded to include pain under tongue on left side. There are times there is no pain and then the pain will come on without known cause, but anytime with eating or chewing the pain starts and is exacerbated. Also impacted by hot items/drinks. I have tried ibuprofen and tylenol sinus medications without impact on episodic flares of pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,01/04/2021,14.0,PVT,none,none,alpha one antitrypsin deficiency,,water chestnuts,"['Condition aggravated', 'Dental examination normal', 'Glossodynia', 'Mastication disorder', 'Oral pain', 'Pain', 'Paraesthesia', 'Radicular pain', 'Temporomandibular joint syndrome', 'Toothache', 'X-ray normal']",1,PFIZER\BIONTECH,IM 922502,WI,61.0,F,red painful lump at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,crohns disease,,,"['Injection site erythema', 'Injection site mass', 'Injection site pain']",1,MODERNA,IM 922503,FL,70.0,M,Client verbalized facial drooping. Client was evaluated by onsite paramedic. Client's symptoms resolved within 10 minutes. Client was transported to medical Clinic for further evaluation at 1:38 pm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,,unknown,"HTN, Hyperlipidema",,Pollen/dust mites,['Facial paralysis'],1,PFIZER\BIONTECH,IM 922511,TX,60.0,F,"I have had a fever ranging from 100.1 to 100.5 since 7 pm on the day I received the 2nd dose vaccine on 1/4/2021. Symptoms include extreme body aches, joint aches, and headache. Today is 1/6/2021 my temp at 7:30 am was 100.3. I have had to miss work yesterday and today so far.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Lamictal Wellbutrin Adderall Ibuprofen,None,None,,Shrimp,"['Arthralgia', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 922512,NY,54.0,F,"LARGE AMOUNT OF SWELLING WITH FIRM MASS ON THE UNDERSIDE OF HER ARM, STARTED 5 DAYS POST INJECTION , WENT TO WALK IN AND WAS PRESCRIBED STEROIDS AND ANTIBIOTIC, NO IMPROVEMENT AS OF 2 DAYS LATER",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,SEN,"Lisinopril, Effexor, Synthroid",none,HTN,SHINGLES VACCINE SAME RACTION SAME ARM,nka,"['Axillary mass', 'Skin induration']",1,PFIZER\BIONTECH,IM 922513,MD,36.0,F,"Lump like feeling under armpit starting day 5-6, itching and raised area at injection site day 6 evening. Day 7- larger hardened red warm to the touch area at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,WRK,"Methotrexate, folic acid, acutane",None,Rheumatoid Arthritis,Developed Rheumatoid arthritis following H1N1 vaccine,None,"['Axillary mass', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 922514,NY,58.0,F,"Patient complained of a tingling sensation running down her arm (R Arm) post vaccination. VS were taken and she was monitored, tingling subsided after about 15 minutes,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,hypertension,,Sulfa,"['Injection site paraesthesia', 'Paraesthesia']",1,MODERNA,IM 922515,TN,44.0,M,"Brachial neuritis Right side with moderate pain along myotome, anesthesia right medial elbow and forearm, and decrease in grip strenth/dexterity digits 3, 4 right hand",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,Cetirizine,None,None,,None,"['Grip strength decreased', 'Hypoaesthesia', 'Neuralgia', 'Radiculitis brachial', 'Spinal pain']",1,PFIZER\BIONTECH,SYR 922516,NJ,54.0,F,"I came home after having the shot, and I was doing my normal at home, and around 5 in the afternoon, I got up and I had aches and pain all over. Then I had a heaviness in my head. Then the chills started. I took two tylenol around 8pm. Then throughout the night, I had really bad chills. My husband gave me more tylenol and it helped. I woke up and I had more chills, and then I checked my temp and it was 101.6. I took more tylenol. I also have this intense tiredness. All my symptoms are like when I had covid in May. My injection site is the width of a flat orange.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,No,No,"No, I had covid in May 2020",,No,"['Body temperature increased', 'Chills', 'Fatigue', 'Head discomfort', 'Injection site swelling', 'Pain']",UNK,MODERNA, 922517,IN,56.0,F,"Extreme vertigo, stomach pain then nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,Levothyroxine Singular Zyrtec Multivitamin Vitamin d calcium Flaxseed oil,None,Anemia Hypothyroidism Obesity HX of asthma,,Morphine Vicodin,"['Abdominal pain upper', 'Nausea', 'Vertigo']",2,PFIZER\BIONTECH,IM 922518,CT,35.0,F,"Headache, mental fog",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Junel-FE,,Asthma,,"amoxicillin , seasonal allergies, fresh fruits","['Feeling abnormal', 'Headache']",2,PFIZER\BIONTECH,IM 922520,FL,38.0,M,"Developed arm soreness x48 hours after vaccine. However, the adverse event is now a rash over my left shoulder. It is tender to touch and blanching. I'm not having fevers or chills. The rash actually itches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,None,None,None,,None,"['Injection site pain', 'Injection site pallor', 'Injection site rash', 'Rash pruritic']",1,MODERNA,IM 922521,TX,33.0,F,Symptoms - ? patient reports itchiness to bilateral forearms approximately 45 after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,['Pruritus'],1,PFIZER\BIONTECH,IM 922522,,28.0,U,"1/6/21. c/o rt shoulder redness, bump, burning sensation to rt arm, limited ROM of rt arm. to send ED for evaluation",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,UNK,Over the counter liver supplement,elevated liver enzyme and under care of PCP,,,NONE,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Joint range of motion decreased']",1,MODERNA,IM 922524,FL,62.0,F,"Within 30 seconds to 1 minute, I had a strange taste in my mouth. It was neither pleasant nor unpleasant, just different. Following this I began to feel bad. It felt as if my blood pressure dropped. I became dizzy and had to hold my head up with my hands. Thank God, I was in my car when I got this injection, or I would have fainted. I felt my temp increase, and my breathing and heart rate became rapid. I used meditation to get my breathing under control, and within a few minutes, I broke out in a cold sweat all over. Then these symptoms subsided and I felt much better. This entire reaction was under 5 minutes. 15 minutes after the injection, a nurse returned to my car and I told her that the vaccine triggered a hot flash or something. My arm became very sore, and that night I felt a goose-egg lump, very warm at the injection site. Also, the left side of my throat felt tight, and it hurt. This morning my arm is still very sore, but no lump, and my throat feels better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,none,none,menopause,,"doxycyclin, hydrocodone","['Blood pressure decreased', 'Body temperature increased', 'Cold sweat', 'Dizziness', 'Feeling abnormal', 'Heart rate increased', 'Hot flush', 'Injection site warmth', 'Pain in extremity', 'Respiratory rate increased', 'SARS-CoV-2 test negative', 'Skin mass', 'Taste disorder', 'Throat tightness']",1,MODERNA,IM 922526,,30.0,F,"rash on face, 30 minutes later",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/21/2020,0.0,UNK,,,,,,['Rash'],1,PFIZER\BIONTECH,IM 922527,OH,54.0,F,"The day of vaccination, patient had a headache. Knot at injection site on right side kept her awake that night. 12/25/2020 a lymph node in armpit on side of injection became sore and inflamed. On 1/1/2021 several lymph nodes on the right side became sore and inflamed. One knot at the base of her neck at the collar bone is inflamed enough to see it. Patient has taken Tylenol for symptom managment",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,"Lisinopril, levothyroxine, lovastatin, naproxen, Claritin, Zyrtec",None,"Hypothyroidism, hypertension, high cholesterol. Had malaria and dysentery in the past",,Sulfa antibiotics,"['Headache', 'Injection site nodule', 'Lymph node pain', 'Lymphadenopathy', 'Sleep disorder', 'Swelling']",1,MODERNA,IM 922528,FL,65.0,F,"Intense itching /burning at the injection site, then redness, swelling and rash which is warm to the touch. Also felt achy overall.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2020,01/04/2021,341.0,WRK,"D-3, Flaxseed Oil, Biotin",,,,BACTRIM,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Pain']",1,MODERNA,IM 922529,FL,69.0,M,2:10 pm Client verbalized minor throat spasms. Client was evaluated by onsite paramedics and cleared to go home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,,,"Hyperlipidema, GERD, A-fib and Gout",,Aspirin and NS aids,['Oropharyngeal discomfort'],1,PFIZER\BIONTECH,SYR 922530,GA,45.0,F,"Noticed a mild headache and fatigue before going to bed for the night, about 8 pm on 1/4/21. My jaw on the left felt sore. I took 2 Aleve. Upon waking the next day(1/5/21) , I felt like I had a migraine on the left side of my face. Head, ear, and jaw on the left side was painful. Used Aleve . The pain was still present, although a little less intense the following day (1/6/21). Arm is also sore but much more manageable than the head pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PUB,Fluoxitine 40 mg,No illnesses since Feb 2020.,Chronic migraines Chronic kidney stones Acute pancreatitis,,Allergy to Topomax and Ultram,"['Ear pain', 'Facial pain', 'Fatigue', 'Headache', 'Migraine', 'Pain in extremity', 'Pain in jaw']",UNK,MODERNA,SYR 922531,TX,77.0,M,patient had severe abdominal pain for several days. He visited 3 different ER departments in the days following immunization.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PHM,"acyclovir 800 mg, propantheline 15mg, zaleplon 20 mg, methylprednisolone 4 mg, diazepam 2 mg",,,,"iodides, codeine, latex","['Abdominal pain', 'Computerised tomogram normal']",1,MODERNA,IM 922532,NY,37.0,F,Patient complained of localized itching at site of injection upon receiving the injection,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"sulfa, morphine, oxycodone, strawberries,",,nerve damage,,,"['Immediate post-injection reaction', 'Injection site pruritus']",1,MODERNA,IM 922533,FL,38.0,M,"Pt received vaccine and was sitting in observation for 10 minutes when he started to complain of feeling really warm, skin was flush and he was sliding out of his chair. Pt was assisted to stand and move to another room to lay down and have vital signs taken. During this move he passed out and was assisted to the ground. Pt did not hit his head and was laid flat. At this time emergency protocol was activated and Epi Pen was given to left thigh at 10:42. BP 127/64 P. 64 SPO2 100%. respiration shallow at 18. Pt opened eyes immediately after Epi pen administration. He had no recall of syncopal episode. Pt was transported to ER via ambulance for further evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,MIL,None noted,None noted,None noted,,Had a reaction to Amoxicillin in childhood,"['Fall', 'Feeling hot', 'Flushing', 'Hypopnoea', 'Loss of consciousness', 'Syncope']",1,PFIZER\BIONTECH,IM 922535,,59.0,M,Mild chills and fatigue. Took a couple of Advil. Same repeated the next day evening,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/03/2021,2.0,UNK,None,None,"Hypertension, diabetes, cholesterol",,None,"['Chills', 'Fatigue']",UNK,PFIZER\BIONTECH, 922536,NY,50.0,M,rash near injection site 10 days later,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/06/2021,9.0,PVT,Zyrtec and Cold Calm,none,none,,"Penicillin, mushrooms, blue cheese",['Injection site rash'],UNK,MODERNA, 922537,IA,39.0,F,"Severe numbness tingling in all extremities, numb tongue, left side of face numb, chest pain, hip Pain,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/25/2020,2.0,PVT,"Pepcid, birth control, magnesium, Claritin",,,,"Macrobid, zosyn","['Arthralgia', 'Chest pain', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Laboratory test', 'Magnetic resonance imaging brain', 'Paraesthesia']",1,MODERNA,IM 922538,NY,24.0,F,"Symptoms started at nighttime the same day I received the vaccine. Extreme nausea with vomiting, low grade fever, chills/ night sweats, myalgias, migraine headache. Not relieved by ibuprofen or acetaminophen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,WRK,None,None,None,,"Gluten, Sulfa, penicillins","['Chills', 'Migraine', 'Myalgia', 'Nausea', 'Night sweats', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 922539,TN,23.0,F,"I woke up and my shoulder was very itchy. I looked under my sleeve and there was a rash. The itchiness and rash are new today, however a lump has been present since injection. The rash is directly above the lump. It may be unrelated, but I've also been unusually drowsy (noticed before taking the benedryl). I took benedryl and applied lotion to the rash. My pregnancy began July 4th and I was 28 weeks pregnant at the time of the vaccine. My estimated due date is March 25th, 2021. At the time of the adverse reaction, I am 29 weeks pregnant.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,SEN,"Bystolic, Tylenol, Loratadine",,POTS(Postural orthostatic tachycardia syndrome),,"Allergic to Vancomycin, Bactrim, soy","['Exposure during pregnancy', 'Injection site mass', 'Injection site pruritus', 'Injection site rash', 'Pruritus', 'Rash', 'Somnolence']",1,MODERNA,IM 922540,NY,52.0,F,Felt dizzy Racing heart with chest pressure Some difficulty breathing Clammy palms Placed me in supine position Observation maintained until vitals returned to normal,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Triamterene Montaulklast Levocetirizin Advil Tylenol extra strength (recent dental extraction),Ankylosing Spondylitis High blood pressure Asthma Two dental extractions prior two weeks Received antibiotics x3 for infection of infected broken teeth in jaw dec 2020,Anklosing spondylitis Asthma High blood pressure Allergies,,Penicillin Tetracycline Latex Cats,"['Abdominal discomfort', 'Chest discomfort', 'Cold sweat', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Headache', 'Influenza like illness', 'Oropharyngeal pain', 'Palpitations']",1,PFIZER\BIONTECH,IM 922541,PA,63.0,F,"My right face, around the cheek/mouth area had a feeling like when you get Novacaine and lasted about an hour.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,Zocor20mg and multivitamin,none,high cholesterol controlled with medication,,Sulfa and Latex,['Hypoaesthesia'],UNK,PFIZER\BIONTECH,IM 922544,FL,50.0,F,"Left deltoid area redness, warmth, pain, induration and itching at the injection site morning after injection given (12-30-2020). Fatigue and mild headache were only other symptoms. Affected area progressively got larger on day 3. Took Benedryl 25mg and Aleve 220mg on 1-1-21, affected area better on 1-2-21 (day 3). Swelling , redness, warmth, induration returned on day 7 (1-5-21) with left axillary lymph node swelling and tenderness. Day 8 currently, redness and induration measures 2 3/4 inches by 1 1/2 inches. Called occupational health to report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,"OTC Claritin, OTC Flonase nasal spray, Rx Singulair tablet. Multivitamin, Vit C, Vit D, Vit K2, vit B Complex, Biotin, Ashwaganda, flush free Niacin (Neora Youth Factor)",none,"nasal allergies, migraine with aura (occasionally), mild eczema, benign thyroid nodule",,"Penicillin, some adhesives (tape)","['Fatigue', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Lymph node pain', 'Lymphadenopathy', 'Swelling']",1,MODERNA,IM 922545,VA,72.0,F,"fever (101 highest) headache, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,pantoprazole,no,no,,no,"['Chills', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 922546,NH,67.0,M,"A few days after the vaccine I noticed intermittent muscle twitches in my right neck and right trunk. These are mild and only noticed by me. I am still fully functional, fully active",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/21/2020,5.0,PVT,"Melatonin, Doxylamine, Valerian Root",none,none,,none,"['Blood creatine phosphokinase normal', 'Blood heavy metal abnormal', 'Blood mercury abnormal', 'Blood thyroid stimulating hormone decreased', 'C-reactive protein normal', 'Electromyogram normal', 'Methylmalonic aciduria', 'Muscle twitching', 'Red blood cell sedimentation rate normal', 'Vitamin B12 normal']",1,PFIZER\BIONTECH,IM 922547,OH,43.0,F,"Fever (101.4), nausea and vomiting, lump at site of injection",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Injection site mass', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 922548,MS,31.0,F,"One week post 1st vaccine, developed localized red area at injection site approx. 3 inches in diameter, warm to touch, slight itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,Vitamins,None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 922549,UT,35.0,F,"Severe Headache, Vomiting, Lymph node swelling in left arm Took tylenol and Meloxicam-little relief from symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Leflunamide, NP thyroid, folic acid, progesterone, spirinalcatone, meloxicam",Rheumatoid Arthritis,Chronic,,Dairy,"['Headache', 'Lymphadenopathy', 'Vomiting']",1,PFIZER\BIONTECH,IM 922551,CA,62.0,F,"1 week after, my arm suddenly had a rash at the site, and sore again. 2 weeks after, my feet and ankles have started to swell.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PVT,"Progesterone, Estrodial, Krill Oil, Vitamin D",,Sjogrens Syndrome,,Cipro,"['Injection site pain', 'Injection site rash', 'Joint swelling', 'Peripheral swelling']",1,MODERNA,IM 922552,,59.0,F,"3-4 days after vaccination, developed swollen lymph node on neck, on same side as vaccine. Also, L arm developed itchyness 7-8 days after vaccination. Will be cleared by PCP prior to 2nd dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/31/2020,3.0,UNK,,,,,,"['Lymphadenopathy', 'Pruritus']",1,MODERNA,IM 922553,OK,60.0,F,Lymph nodes are swollen and painful in left arm pit. Some swollen and red at injection site. Tired.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/31/2020,3.0,PVT,Generic flexeril Emergen-c Ibuprofen Benadryl,None,None that I?m aware,"To flue shot. Swollen, red and some hives. It was manageable",Wasp,"['Fatigue', 'Injection site erythema', 'Injection site swelling', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,SYR 922554,IL,61.0,F,"I went to the emergency room which after the Pfizer injection I had numbness sensation to my face and upper lips, nose and mouth. I feel a pulling sensation to her lips and nose. I have brain fog. I feel the injection affected a nerve in my face. She went to see her primary doctor put her on anti-histamine medication. She states she has no itching at the moment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,PVT,"Prednisone 20mg BID, Pepcid, Benadryl, Anti-histamine",,"Breast Cancer 8 years ago, migraine headaches",,"Penicilllin, Hydrocodone Acetomenaphine, Cholorehexadine glutenate, Ciprofloxacin","['Facial nerve disorder', 'Feeling abnormal', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Sensory disturbance']",1,PFIZER\BIONTECH,IM 922555,MA,37.0,F,Red rash around injection sight that is tender and raised. Some white coloring around red area. It is not itchy and does not hurt. its oval in shape and is about one inch in width and 2.5 inches long,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,birth control and blood pressure medication,none,high blood pressure,,none,"['Injection site rash', 'Pain of skin', 'Rash erythematous', 'Rash papular', 'Skin discolouration']",1,MODERNA, 922556,KS,39.0,F,"at 1805: associate c/o throat tightness, increased heart rate, and slight facial edema. VS: 144/103 (BP), HR 101, oxygen sat 99%. at 1807: associate took own dose of Alegra and oral Benadryl. at 1808: given two puffs of Albuterol inhaler 90mcg/puff at 1815: BP 135/96. HR 86. at 1830: BP 139/95. HR 82. associate up without any problems to restroom. at 1840: symptoms not completely resolved so took dose of own Benadryl at 1850: oxygen sat 97 and HR 76. at 1900: BP 140/91. HR 77. Associate back to baseline and discharged to home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Face oedema', 'Heart rate increased', 'Throat tightness']",1,PFIZER\BIONTECH,IM 922557,ND,36.0,F,"Pt. had large hive appear at site of injection 7 days post injection. as of now, no further issues.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/06/2021,9.0,PVT,multivitamin daily,none,CKD,,Plaquinel- hives PCN-rash,['Injection site urticaria'],1,MODERNA,IM 922558,IL,49.0,M,4:00 PM arm hurt a little bit. At midnight was freezing like nobody's business and this lasted 4 hours. Chilling. Arm pain and whole body hurts. From toe nails to hair. All joints hurt. Could not sleep.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PUB,Olmefartin 20 mg 1 po qd allopurinal 100mg 1 po qd zocar 20 mg 1 tablet qd,None Hx Covid mid November 2020,hyperlipidemia HTN gout,,None,"['Arthralgia', 'Chills', 'Feeling cold', 'Pain', 'Pain in extremity', 'Sleep disorder']",1,MODERNA,IM 922559,PA,65.0,F,Racing heart maximum rate 156 Palpitations Anxiety Symptoms lasted approximately 4 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,Synthroid Olmasartin Rousuvastatin Asa,,Hypertension,,Erythromycin Ceftin,"['Anxiety', 'Palpitations']",1,PFIZER\BIONTECH,SC 922560,CT,,F,Woke up a week later after vaccine and the injection site area is red swollen and itchy. It had a hard lump but I took a Zyrtec and it seems to be going down. Still warma nd swollen but the Zyertec seems to be helping.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,WRK,"statin 40mg. Multi vite, flaxseed, vite D, zinc, Vite C,",no,no,pneumonia shot -2016-2017,latex,"['Injection site erythema', 'Injection site induration', 'Injection site mass', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 922561,,69.0,F,"Pt. reported ""ocular migraine"" a few hours after receipt of vaccine. Reports visual disturbances. No hx of migraines. Resolved without intervention.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['Migraine with aura', 'Visual impairment']",1,MODERNA,IM 922563,NY,38.0,M,"Woke up with Right Arm Pain and SEVERE Body aches. Took long hot shower, 600mg Motrin.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Daily MultiVitamin,none,none,,PCN,"['Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 922565,AR,43.0,F,"I developed intermittent Bilat leg numbness on Jan 2nd and 3rd. On Jan 4th the bilat lower leg numbness was constant all day and around 4 pm that same day I developed right forearm numbness. On Jan 5th the symptoms have seemed to have resolved in my legs, right forearm is still slightly numb. No weakness present just numbness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2019,01/02/2021,369.0,OTH,none,None,None,,None,"['Hypoaesthesia', 'Neurological examination']",1,PFIZER\BIONTECH,IM 922566,,45.0,F,"Pt. Type 1 DM. Developed lighheadedness, shakiness, and palpatations within 10 minutes of receiving vaccine. blood sugar WNL.. Observed in ED x 30 additional minutes and released with interventions.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Dizziness', 'Palpitations', 'Tremor']",1,MODERNA,IM 922567,FL,60.0,F,"hives, itching on neck, chest, shoulders. Treated with Benadryl, will contact Dr. today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/03/2021,10.0,PVT,"Zetia, Prozac, Wellbutrin, Vascepa, Metoprolol, Synthroid, Estrogen, Prilosec",none,Hypertension Low HDL Menopause,see previous note,"Severe allergic reaction to 2nd dose of Heptavax vaccine in 1983. In later years, have been able to tolerate all vaccines needed for employment.","['Pruritus', 'Urticaria']",1,MODERNA,IM 922568,IL,41.0,F,"The night I received the vaccine, I was ordered to wait, then when I got home, I had a red welp on my arm. The welp stayed pass a few days, then today it has tripled in size and is very hard and heated. It is still tender to the touch and is very very hot.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,No,No,"Hypoglycemia , Anemia , History of anaphylactic reactions.",,"Mushroom, Shellfish, and Penicillin","['Erythema', 'Pain of skin', 'Skin induration', 'Skin warm', 'Urticaria']",UNK,MODERNA, 922569,WI,36.0,F,Employee received Pfizer COVID-19 vaccine on 12/23/2020. Waited 15 minutes after immunization and felt fine. Started to have a hot flash on the way home. Then her tongue felt sluggish but not swollen. She had a few minutes having difficulty swallowing but denies a sensation of throat swelling. Arm became sore and heavy but no redness. Drove back to the hospital with the onset of these symptoms and waited in the parking lot for 15 minutes to see if the symptoms were going to progress but they didn't. Stated she became very fatigues for a few hours but felt fine the next day except for a sore arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"Levonorgestrel IUD, acetaminophen (PRN), multivitamin, ibuprofen (PRN)",None,Increased BMI,,None,"['Dysphagia', 'Fatigue', 'Hot flush', 'Limb discomfort', 'Pain in extremity', 'Tongue movement disturbance']",1,PFIZER\BIONTECH,IM 922570,GA,60.0,F,"Pfizer BioNTech COVID-19 Vaccine EUA Patient given vaccine and nurse used CDC screening check list. Patient's noted yes to allergies made nurse talk to lead nurse regarding allergies. Plan of care was to vaccinate but have patient stay at least 20 minutes. During the 20 minute wait, the observer was notified by patient she was having some throat tickling and tightening. Observer notified lead nurse. Lead nurse approached patient and had her move from waiting area back into her nurses room. Patient complained of throat tickling and tightening but stated she was fine. Nurses noted increasing coughing. Pulse ox and respirations checked. Patient continued to state she was fine and was not in physical distress. Nursing director was called and nurses advised to give epi and follow protocol. Epi given in left thigh. Patient vitals monitored and patient was able to tell throat started to loosen and coughing stopped. 911 called but patient refused transport after EMS assessed patient. Nursing Director discussed patient incident with Medical Director and nurses were advised to administer a IM dose of benadryl. Patient agreed and verbalized understanding her risks of not going to ER for monitoring. Patient signed refusal for treatment form and planned to call her doctor when she left. Patient vitals were stable and patient left clinic on her own accord around 11:00 am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,,,,,"Shellfish, PCN, Iodine and contrast from CT","['Cough', 'Oropharyngeal discomfort', 'Throat tightness']",1,PFIZER\BIONTECH,IM 922571,IN,74.0,F,"At the Hospital vaccination clinic we had a patient present for her appointment. Patient was greeted by a new patient registration person. Patient stated that her appointment was either yesterday (1/1/2021 or tomorrow 1/3/2021) when in fact her appointment was scheduled for 1/8/2021. The new registrar did not catch the upcoming appointment and made a new appointment for today. Patient received her first vaccination of Pfizer on 12/18/2020. Her second appointment was scheduled for 1/8/2021. She did not inform the registrar or vaccine administrator that she had received a previous shot. Subsequently, she received a vaccination of Moderna on 1/2/2021. We have not been successful in connecting with patient to check on her status nor offer recommendations.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,PVT,,,,,,['Product substitution'],1,PFIZER\BIONTECH,IM 922572,NJ,59.0,F,"I developed an immediate headache with 5-10 minutes that subsided after 15-20 minutes. Started feeling muscles achy after about an hour and feeling punky, at 2:45 minutes post IM feeling flushed ensued with red face and glassy eyes, needing to sit down due to fatigue , very thirsty, then joint pains especially feet making standing and walking prolonged painful, started with slight cough took advil and needed to go home from work by 3:30 minutes post receiving vaccine. SOB ,4 pillow orthopnea at hour 4-5 , needed prednisone by evening and duo neb by morning. Drenching swets all night.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,vitamins,none,"Intermittent asthma, obesity,",,none,"['Arthralgia', 'Cough', 'Dyspnoea', 'Erythema', 'Fatigue', 'Feeling abnormal', 'Flushing', 'Glassy eyes', 'Headache', 'Hyperhidrosis', 'Immediate post-injection reaction', 'Impaired work ability', 'Myalgia', 'Night sweats', 'Orthopnoea', 'Thirst']",1,MODERNA,IM 922573,CT,59.0,F,"I had tiredness, Headache , Muscle Spasms",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/23/2020,2.0,PVT,Singulair Cardizem Levothyroxine Bustar Heptid Arnuity inhale astelin Vitamin D6 d12 d Calcium Citrate,Nonne,Asthma Autoimmune Alopecia Autoimmune thyroid disease,,sulfa Sun Tan lotion Dogs Cats trees mold,"['Fatigue', 'Headache', 'Muscle spasms']",UNK,PFIZER\BIONTECH,IM 922575,FL,72.0,F,At approximately 10:00am on 1/5/2020 the client received her first Moderna vaccine. At approximately 10:15am while waiting the 15 minutes client said to the paramedic on site she felt like her throat was swelling and had SOB. BP 211/110. A physician arrived on the seen and instructed the paramedic to start an IV. Fire Rescue call at 10:47am and she was taken to medical facility via ambulance. She was evaluated and released home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2020,01/05/2020,0.0,PUB,Unknown,Hypertension,Hypertension,,"Suprex, Keflex, milk, cats","['Dyspnoea', 'Pharyngeal swelling']",1,MODERNA,IM 922577,OH,61.0,F,"Headache, fever, shaking, nausea, diahhrea, body aches, dizziness, cough and heart racing. This last for about 48 hours. This is day7 and I still nausea and no energy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,SCH,"Cymbalta, multivitamin, calcium, fish oil",I was diagnosed with Covid on November 21,,,Reglan Sulfar,"['Asthenia', 'Cough', 'Diarrhoea', 'Dizziness', 'Headache', 'Nausea', 'Pain', 'Palpitations', 'Pyrexia', 'Tremor']",1,MODERNA,SYR 922578,NC,27.0,F,"12/31 Fever and Boday Aches 1/1 Itchy rash, both arms Treatment Tylenol, Benadryl, Hydrocortisone creme Outcome as of 1/4, fever gone, rash continues.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PVT,"Birth Control Pills, Zyrtec, Flonase, Citalpram 10 mg, One a Day Women's Vitamin","IBS, Seasonal Allergies and Anxiety","IBS, Seasonal Allergies and Anxiety",,None,"['Pain', 'Pyrexia', 'Rash', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 922580,FL,70.0,F,Began to develop rash on neck and front chest on 12/31/2020; progressive got worse and spread to upper arms on 1/3/2021. Rash continues and on 1/5/22021 spread to lower ext extremities. Taking Benadryl 50 Mg at night and Allegra 180 during the day to manage the rash. Mild chest pain on the left upper chest; cannot differentiate if it was a muscular pain or actual chest pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,OTH,"Synthroid 10 mcg, Estradiol 10 Mcg, Multi Vit, Calcium, Vit E,",None,None,,"Penicillin, Augmenting, codeine","['Chest pain', 'Myalgia', 'Rash']",1,MODERNA,IM 922581,IN,66.0,F,HR usually in 80s (via watch). Increased to 109.. Felt Anxious. Placed in a wheelchair for patient safety and rolled to a private area for monitoring. Blood pressure checked 166/76. Gave water and nutragrain bar. HR decreased back to 80s within 5 minutes and anxiety resolved. Patient is a dietician. However she did not eat breakfast this AM. Also stated she gets anxious with shots.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,,,,,,"['Anxiety', 'Heart rate increased']",1,MODERNA,IM 922583,WV,56.0,F,"Extreme pain in Right shoulder approximately 4 hours post injection and later difficulty lifting Right arm. Shoulder pain moved into and included the axilla approximately 9 hours post vaccination. During the night, approximately 16 hours after vaccination, I began to have radiating, shooting pain up both sides of my neck up into the ears. This neck pain lasted approximately 72 hours. The arm pain had resolved at approximately 30 hours. The neck pain lessened and resolved with repeat applications of heat and Ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,Verapamil; Maxide; Synthroid Vitamin D 2000 units; B Complex OTC,,Graves Disease; Supraventricular Tachycardia; Vertigo; Gallbladder Disease-Pancreatitis,,Doxycycline,"['Arthralgia', 'Axillary pain', 'Ear pain', 'Injected limb mobility decreased', 'Neck pain', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 922585,NV,51.0,F,"Gastro problems, diaherra , muscle aches, my whole body hurts, nausea, headache, very very tired...I have taken a tums and just slept since 1/5/2021 at 4:00p. I have no appetite.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Metformin 500 mg. Amlodipine 2.5 mg. Metoprolol 50mg. Losartan100mg. 2 Tylenol 500mg,No illiness,"High blood pressure, depression, diabetes",,None,"['Decreased appetite', 'Diarrhoea', 'Fatigue', 'Gastric disorder', 'Headache', 'Myalgia', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,SYR 922586,AZ,39.0,M,Shortness of breath Fatigue Cough,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,Metoprolol Succinate ER Famotidine Losartan Hydrochlorothiazide Tadalafil Garlic A B1 B12 B2 Biotin C Calcium Chromium Copper Oxide D3 E Folate K Lycopene Magnesium Oxide Manganese Niacin Pantothenic acid Pyrroloquinoline Quinone (PQQ) Que,None.,Drug Resistant Hypertension Asthma,,Atenolol Ceftriaxone Amlodipine Lisinopril Nifedipine,"['Cough', 'Dyspnoea', 'Fatigue']",1,MODERNA,IM 922587,NY,34.0,F,Sligh soreness at the injection site tiredness persistent headache bloating and gassiness stomach upset slight nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,None,"No, the vaccine was administered a the end of my menstrual cycle.",No,,No,"['Abdominal discomfort', 'Abdominal distension', 'Fatigue', 'Flatulence', 'Headache', 'Injection site pain', 'Nausea']",1,MODERNA, 922588,GA,26.0,M,"Persistent 102+F fever unresponsive to Tylenol. Diffuse overwhelming weakness unable to even open a water bottle. Severe chills, body aches, and headache. Nausea and feeling of vomiting. Pain at injection site. Symptoms started as exhaustion and body aches approximately 7-8 hours after receiving vaccination. Symptoms became more severe as time progressed through the night. Still having moderate to severe symptoms almost 24 hours after receiving vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Zinc 30 MG, vitamin D3, Boron 9 MG, multivitamin, aspirin 325 mg",Covid-19 diagnosed 12/4/2020,None,,None,"['Asthenia', 'Chills', 'Drug ineffective', 'Fatigue', 'Grip strength decreased', 'Headache', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 922589,TX,21.0,F,"Patient was awoken about 6:25am with severe pain at injection site, sweating, shaking all over and nausea. Patient took 4- 200mg ibuprofen at 6:30am. Patient fell back asleep and awoke at 8:40am. Patient stated that arm is still in pain, still sweating. Nausea and shaking has gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,None,Patient diagnosed with flu 12/23/2020. Patient asymptomatic but was given tamiflu. Patient took 2-3 days worth of Tamiflu.,None,,None,"['Hyperhidrosis', 'Injection site pain', 'Nausea', 'Tremor']",1,MODERNA,IM 922590,PA,33.0,F,Approximately 5 days after receiving the vaccine I woke up and my left arm was sore to extend and to the touch. On the side bicep and forearm. The next day I noticed a lump in my underarm. After that a raised red mark appeared on the outside of my arm near the injection site. Only used a warm compress.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,OTH,"levonorgestrel, vitamin C, vitamin D, levocetirizine",,Cat allergy,,Cats,"['Axillary mass', 'Injection site erythema', 'Injection site swelling', 'Pain', 'Pain of skin', 'SARS-CoV-2 test']",UNK,MODERNA,IM 922591,NM,50.0,F,Vaccinated 1510. Observed until 1530. at 1540 it was reported that she had chest tightness. no trouble breathing but substernal chest pain 8/10. Vital signs- Temp-97.9 Pulse-95 BP- 162/100 Resp- 22 oxygen saturation- 95 @ room air. 1600- transported to ER for evaluation and treatment.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,Hypertension,Hypertension,,No known allergies,"['Chest X-ray normal', 'Chest discomfort', 'Chest pain', 'Metabolic function test normal', 'Troponin normal', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 922592,IN,74.0,F,"On 1/2/2021, at the Hospital vaccination clinic we had a patient present for her appointment. Patient was greeted by a new patient registration person. Patient stated that her appointment was either yesterday (1/1/2021 or tomorrow 1/3/2021) when in fact her appointment was scheduled for 1/8/2021. The new registrar did not catch the upcoming appointment and made a new appointment for today. Patient received her first vaccination of Pfizer on 12/18/2020. Her second appointment was scheduled for 1/8/2021. She did not inform the registrar or vaccine administrator that she had received a previous shot. Subsequently, she received a vaccination of Moderna this morning. Patient has not responded to our attempts to reach for monitoring check and/or recommendations.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,PVT,,,,,,['Product substitution'],1,PFIZER\BIONTECH,IM 922593,MA,31.0,M,Jaw pain and uncomfortable to bite down. Was seen at urgent care. MD prescribed naproxen and flexeril and adverse event has since improved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Mastication disorder', 'Pain in jaw']",1,MODERNA,IM 922594,NH,36.0,F,"A few hours after the vaccine my arm hurt. The next day (1/5/21) the body aches and nausea started. I wasn't worried because this is well known for side effects from the vaccine but I wasn't prepared for the heart palpitations and tachycardia I had for about 4 hours the night of 1/5/21. I had COVID in May 2020 and per my cardiologist probably had myocarditis that I am still taking a beta blocker for as a result of the COVID infection. There may or may not be a link between the immune response to the vaccine and my previous COVID complications. The morning of 1/6/21, I am pretty much back to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"Metropolol, atorvastatin",,asthma,,penicillin,"['Nausea', 'Pain', 'Pain in extremity', 'Palpitations', 'Tachycardia']",1,MODERNA,IM 922595,NE,40.0,F,"Rash appeared on 1/2/2021, last 36 hours and disappeared. Rash re-appeared on 1/5/2021 in the AM, large and red, slightly warm. No fever, no itching, no tenderness to touch. Got bigger over night and on 1/6/2021 rash still present.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/02/2021,9.0,PVT,Lexapro,none,none,,none,"['Rash', 'Rash erythematous', 'Skin warm']",1,MODERNA,IM 922596,NY,44.0,F,"It started with a neck ache, then chills ,muscle aches , headache, bone pain to my forearms and fever. 101.8 after Motrin, this morning 100.5.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,Motrin for fever/body aches,None,No,,Hives to a whey protein meal bar and shake (assumed),"['Bone pain', 'Chills', 'Headache', 'Myalgia', 'Neck pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 922598,NY,50.0,M,nauseous vomiting headache dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PVT,valsarten/sertraline/tamulosin,none,hypertention nerve pain,,bees,"['Dizziness', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 922599,NJ,31.0,F,"Sore arm, could not lift arm 1/5/2021 12:30PM - 11:00PM Sore arm 1/5/2021 11:00PM - current Nausea, fatigue 1/6/2021 7:00AM - current",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,none,none,none,,none,"['Fatigue', 'Mobility decreased', 'Nausea', 'Pain in extremity']",1,MODERNA,SYR 922600,IL,35.0,M,Patient tolerated injection well. Post vaccination the patient was scheduling his second appointment when he passed out at our clinic. He fumbled around the room and hit his back on the chair. After patient came to we called his wife and contacted MD. Patient's wife drove him to medical facility to be examined and cleared.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,n/a - unknown,,,,,"['Back injury', 'Loss of consciousness']",1,MODERNA,IM 922601,MA,26.0,F,Left side of face and left forehead were numb. Lasted approximately one hour. Went away on it's own.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,,['Hypoaesthesia'],1,MODERNA,IM 922602,IN,61.0,F,"8 days later, after receiving vaccine, developed warm reddened, slightly raised 45X55mm area at injection site. Not painful. Slightly itchy. Will monitor to see how long it lasts or change in status.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/06/2021,9.0,OTH,"Allegra, over 50 multivitamin",none,mild asthma triggered by environmental factors,,"sulfa, ragweed, animal dander","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 922603,OH,46.0,F,"same day felt run down ""like crap"". 1.5 hour later, felt heart palpitations. Nausea. That night was sweating profusely. Pain at injection site. Was not able to lift left arm (site of injection) at all. Following day, lost all control of left hand and experiencing tremors for about 10-15 minutes. Arm still not feeling right (8 days later). Still having palpitations and tenderness at injection site. Injections site still hot, red itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,"estrogen pill, vitamins",none,none,,bactrim,"['Feeling abnormal', 'Hyperhidrosis', 'Injected limb mobility decreased', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Nausea', 'Palpitations', 'Tremor']",1,MODERNA,IM 922605,,42.0,F,Received Moderna lot 0225J20-2A on 12-29-2020 in the left arm. 1-5-2021 developed redness and soreness at insertion site. She state that one of her lymph node in her neck is also sore and swollen,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/05/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site pain', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 922606,TN,45.0,F,"fever, chills, body ache, headache, vomiting and diarrhea The fever, chills, body ache and headache started around 8 pm, diarrhea started at 9:00 pm and vomiting started at 10 pm. The vomiting and diarrhea lasted until early morning hours (around 6:00). The fever, chills and body ache ended the next day. I took an Aleve around 10:00 am and the headache went away.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,PUB,"Pentasa,Imuran, B-12 injection and Ocella",,Chrin's disease,,Penicillin,"['Chills', 'Diarrhoea', 'Headache', 'Pain', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 922607,GA,26.0,M,"Sore/nauseas stomach, light headed",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,SCH,,,,,,"['Abdominal pain upper', 'Dizziness', 'Nausea']",2,PFIZER\BIONTECH,IM 922608,KY,58.0,F,RED SLIGHTLY SWOLLEN ITCHING AT INJECTION SITE,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 922609,MS,28.0,M,"7 AM 01/06/2021: Soreness at injection site, fatigue 9 AM 01/06/2021: Soreness at injection site, fatigue, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PUB,None,None,None,,None,"['Fatigue', 'Injection site pain', 'Nausea']",1,MODERNA,SYR 922610,NJ,31.0,F,"Sore arm, could not lift arm 12:30pm - 11:00PM Sore arm 11:00PM - current Nausea 7:00am - current",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,none,none,none,,none,"['Mobility decreased', 'Nausea', 'Pain in extremity']",1,MODERNA,SYR 922612,NC,45.0,F,"Raised, red, itchy rash on injection arm. Treated with topical hydrocortisone, oral cetirizine, oral famotidine. Rash resolved by approximately 90% after ~3-4 hours post-medications.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/06/2021,9.0,WRK,None,None,None,,Allergies to wasps and hornets. Receive allergy shots every 8 weeks since ~2001 for these.,"['Rash', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",1,MODERNA,IM 922613,NY,49.0,F,"This is not an adverse report. This is a report of suboptimal injection. The nurse reports that some of the vaccine ""ran down the subject's arm"" after injection. The cause of this is unknown - perhaps a leaky hub or improper injection technique.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,PVT,Not recorded at this visit.,Not recorded at this visit.,Not recorded at this visit.,,Not recorded at this visit.,"['Exposure via skin contact', 'Syringe issue', 'Underdose', 'Wrong technique in product usage process']",1,MODERNA,IM 922614,FL,28.0,F,"Extreme fatigue day of vaccine. Headache, fever, body aches, nausea, dizziness two days post vaccine. One week post vaccine developed redness at injection site. Redness has been spreading and is warm to the touch. Pain at the injection site and radiating up and down left arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,"Synthroid 88mcg qd, Oxcarbazepine 150 mg BID, Lamotrigine 200mg one-half q am and 1 q pm, Venlafaxine ER 75mg 1 qd, Carvedilol 3.125mg BID",none,"Hashimoto's Thyroiditis/Hypothyroidism, Hypertension, Anxiety, Bipolar Depression II",,"sulfa, cefdinir","['Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site warmth', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 922615,IL,37.0,F,"1) Throat got tight 2) numb around my mouth 3) felt like i had nauseating, water in my mouth 4) tingly all over my face",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Hypoaesthesia oral', 'Nausea', 'Paraesthesia', 'Throat tightness']",1,MODERNA,SYR 922624,MD,38.0,F,"swollen, red, hot, itchy, circle about 9 cm circumference with right arm pain directly around injection site. in addition, a cold sore on the same day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,OTH,Vitamin C Ashwagandha Keratin Astaxanthin Collagen,,,,Grass Amoxycillian,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Oral herpes', 'Pain in extremity']",1,MODERNA,IM 922625,TN,75.0,F,"Chills, fever, muscle and body aches, headache, fatigue, vomiting and nausea for three days. Right arm sore and a rash with smelling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PUB,Aspirin Levothyroxine Plavix Atorvastatin coreg Gabapentin Isosorbide Mono er,none,Coronary Artery Disease Asthma,,none,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'Rash', 'Vomiting']",1,MODERNA,IM 922626,IN,64.0,F,"About 2 hours after injection, patient felt a big lump on throat to the point of it almost closing. Pt got over the counter benedryl and took some on her way home from work where she received the vaccine. Had chills during the night. Patient still has lump on throat but it is about 50% recovered. Throat is sore also and voice changed a bit.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Valsartan 40 mg and Euthyrox , Liothyronine Vitamin c, B12.",no,no,,Erythromycin and penicillin.,"['Chills', 'Dysphonia', 'Oropharyngeal pain', 'Sensation of foreign body']",1,MODERNA,IM 922627,OH,62.0,F,"Report of hives, body aches, soreness in the arm",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,Benadryl Allegra Flonase Adderall Naproxen,Unknown,Unknown,,Sulfa Sensitivity to Iodine,"['Pain', 'Pain in extremity', 'Urticaria']",1,MODERNA,IM 922628,TN,44.0,F,I got the vaccine and three hours later I had both legs below the knee go numb and start tingling . They are still tingling today but the numbness went away the day after I had the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,URSODIOL CAP 300 mg,none,Primary biliary cholangitis,,none,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 922629,CA,36.0,F,Severe joint pain and muscle aches rash on hands,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/29/2020,3.0,UNK,,,,,,"['Arthralgia', 'Myalgia', 'Rash']",1,MODERNA,SYR 922630,IA,32.0,F,"Mild headache and light headed for around 2 hours. Dry mouth for around 4 hours. I took 500mg Naproxen for the headache, and drink water for the dry mouth",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Rizatripan, Spironolactone",none,none,,none,"['Dizziness', 'Dry mouth', 'Headache']",2,PFIZER\BIONTECH,IM 922631,CT,58.0,M,"Aches, Dizzy, Chills, high pulse rate, cant sleep",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,simvistatin - lethrodroxine,none,none,,no,"['Chills', 'Dizziness', 'Heart rate increased', 'Pain', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 922632,AR,17.0,F,Patient was vaccinated and is under 18. Patient has had no adverse reactions,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PHM,,,,,,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 922633,IA,40.0,F,"1 week after injection (1/5/21), I developed hives around the injection site. They went away on their own last night and a red, swollen circle remains today.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,WRK,,,,,"cockroaches, dustmites, methyldilbromo glutaronitrile/phenoxyethanol (MDBGN/PE-Euxyl K 400), Sodium benzoate, Cobalt (II) sulphate, Copper sulphate, glutaraldehyde, nickel sulfate hexahydrate, cobalt (II) chloride hexahydrate, 1,3-diphenylguanidine, iodopropynyl butylcarbamate, carvone, fragrance mix II, sorbic acid, stearyl alcohol, sodium disulphite","['Injection site erythema', 'Injection site swelling', 'Injection site urticaria']",1,MODERNA,SYR 922634,NY,28.0,F,"Very minimal pain after initial shot on 12/29/2020. Pain subsided and I was well for 6 days no reactions. On 1/3/2021 my armpit became very swollen and painful, on 1/4/2021 the Right arm where I received the injection became severely painful, dull throbbing ache from shoulder down to my fingers. On 1/5/2021 my Right arm was now swollen, hot to the touch and a small red circle was forming on my bicep and pain continued to worsen. Today 1/6/2021 I saw my primary care physician that confirmed there is swollen lymph nodes in the arm pit and swelling at the site. The redness of the spot increased in size from the size of a dime to now the size of a half dollar.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,PVT,"Clonazepam 1mg PRN, Medroxyprogestrone 1mL IM injection Q 3 months, Levothyroxine 25 mcg QD, Tylenol 500mg PRN",None.,None,,Augmentin,"['Axillary pain', 'Bacterial infection', 'Injection site erythema', 'Injection site pain', 'Injection site reaction', 'Injection site swelling', 'Oedema peripheral', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Skin warm']",1,MODERNA,IM 922635,WA,55.0,F,"Within five minutes of the vaccine my face broke out with a rash and was warm to the touch. Doctor took my blood pressure and it was fine, recommended Benadryl when I got home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,WRK,"Bupropion, 150mg Doxyclycline Hyclate, 20mg Vitamin B-12, 2mg",None,Rosacea Low-grade depression,,Allergic to Percocet and Vicodin,"['Rash', 'Skin warm']",UNK,PFIZER\BIONTECH, 922637,CT,39.0,F,"Patient reported ""lump in throat"" to RN observation staff about 20 minutes post-vaccination. MD examined patient, patent reports throat tightness, HYPERtension, cough, dizziness, headache and nausea. Administered EpiPen 0.3 mg IM left thigh and diphenhydramine 25 mg IV. EMS called, reported within 5 minutes and transported to hospital for evaluation. By time of transport, patient reported improvement in respiratory symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,SCH,norethidrone 0.35 mg daily,,"hypertension, overweight",,"Penicillin (swelling), ondansetron (lump in throat), codeine (throat swelling), walnut (anaphylaxis)","['Cough', 'Dizziness', 'Headache', 'Hypertension', 'Nausea', 'Sensation of foreign body', 'Throat tightness']",1,MODERNA,IM 922638,IN,61.0,F,"8 days after receiving dose #1 of the COVID-19 vaccine, upper arm developed warm reddened, slightly raised 45x55mm area at injection site. Not painful. Slightly itchy. Will monitor to see how long it lasts or change in status.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/06/2021,9.0,OTH,"Allegra, MVI for over 50",none,mild asthma triggered by environmental factors,,"Sulfa, ragweed, animal dander","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 922639,OH,61.0,F,"severe headache, hot, flush, nausea. patient took own ibuprofen from purse",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Feeling hot', 'Flushing', 'Headache', 'Nausea']",1,MODERNA,IM 922640,MN,64.0,M,"64-year-old male who presented to the clinic with complaints of left-sided weakness on his face. He stated when he woke up this morning he noticed that the left side of his mouth drooped and that he could not close his left eye all the way. Yesterday he felt fine. Today he went to work. Patient stated that on 12/18 he got the COVID vaccine. It was on a Friday. The following day he had a headache and he felt flu-like. He stated that those symptoms resolved quickly. He then had the facial weakness today (11 days after the vacciantion). He has not had any fever, sweats, or chills. Patient stated that he had called ask a nurse, and he was advised to hang up and call 911 and go to the emergency room. However, he stated he was an EMT and did not feel that was necessary. He denies headache. He has not had any vision change. He has been eating and drinking well without any difficulty. PHYSICAL EXAMINATION: General appearance - patient was not in any distress. He was conversant, pleasant and appropriate. HEENT - normal conjunctivae and lids. Sclerae anicteric. Pupils equal and reactive to light. Patient was not able to close his left eyelid. Normal ear canals. TMs are pearly gray with bright light reflex. Neck - supple. No lymphadenopathy. Skin - pink, warm and dry. Neuro - alert and oriented. Deep tendon reflexes 2+ upper and lower extremities with no focal weakness. Normal range of motion. Patient can raise his right eyebrow. Could not raise his left eyebrow. There was impaired eyelid closure on the left; tight closure on the right. Smiling of the face revealed lateralization to the right side. When frowning, he had upper and lower facial paralysis on the left with flattening of the forehead. The patient could not tighten the left side of his mouth. � ASSESSMENT: Bell's palsy. � PLAN: Discussed pathophysiology of Bell's palsy. Advised patient I recommended him to call the number that he got with the information when he received his COVID vaccine. Advised patient that I could not definitively correlate the Bell's palsy with the COVID immunization, but that he can call the number he has to let them know of his symptoms. Discussed treatment options. Since patient woke up with his symptoms this morning, I advised patient that he would have hopefully the best outcome because he would be able to get on the steroid and antiviral soon after developing the symptoms. He is to wear an eye patch to prevent corneal drying or abrasion of the left eye at night. Using Lacri-Lube at night before placing the eye patch and then following up by using artificial tears during the day. � Patient was placed on prednisone 60 mg once a day for 1 week to be taken with food. Valtrex 1,000 mg 3 times a day for 1 week. � Side effects of medication discussed. Handouts were provided. He will follow up with PCP if any changes or concerns. Advised patient that it may take up to 3 weeks before all his symptoms have resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/29/2020,11.0,PVT,,,,,,"['Eyelid function disorder', 'Facial paralysis', 'Facial paresis', 'Headache', 'Influenza like illness']",1,PFIZER\BIONTECH,IM 922641,MT,32.0,F,"Starting the evening of 1/5/2021, week after shot, the injection site is red, swollen, itchy and hot",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,Aller-Tec,none,none,,chlorahexadine,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 922643,TX,30.0,F,"First I started itching really badly starting in my head then working its way all over my body then my blood pressure went up to 158/108. Recheck and it was 158/98, went home and took some benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/26/2020,0.0,WRK,,,,,"rosphyane, tomatoes, shell fish, red, iodine","['Blood pressure increased', 'Pruritus']",1,MODERNA,IM 922644,VA,28.0,F,"Chills, body aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Lexapro and Otezla,None,Depression.,,No,"['Chills', 'Fatigue', 'Pain']",2,PFIZER\BIONTECH,SYR 922645,MI,66.0,F,Severe headache and nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,UNK,None,None,"Colitis, Restless Leg syndrome",,"Morphine, codeine, erythromycin","['Headache', 'Nausea']",1,PFIZER\BIONTECH,SYR 922646,MO,66.0,M,"Starting about 16 hours post-injection, left arm was becoming very sore and painful to move.. almost 24 hours post-injection I started getting strong chills. I was shivering and chattering on the walk out to the car (it was 30 degrees outside). When I got home, even though it was New Year's Eve, I put a light jacket on and sat in my cozy chair most of the evening, celebrated New Year's with the family, then I had to put on flannel pajamas in order to be warm enough to sleep. I usually don't have to wear pajamas to bed. And for most of New Year's Day I kept the pajamas on and a light jacket and I was in my chair most of the day trying not to shiver. The shivering finally stopped late on the First, about 54 hours post-injection. And over the weekend the pain in my arm slowly went away, and by now, one week post-injection, I feel no pain in my arm at all.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Hydrochlorothiazide, Toprol, Metformin, Eloquist",None,"Five years post DVT with 50% PA, treated with heparin and now Eloquist",,"Don't laugh, ripe black olives","['Chills', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 922648,NJ,61.0,F,"Shortly following vaccination, employee reported tongue tingling. She had no difficulty swallowing or breathing. She was evaluated by the physician present at the clinic who felt it might be angioedema. She was observed for an extended time and cleared to return to work at the hospital. No treatment was given.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,,,,,,['Paraesthesia oral'],UNK,PFIZER\BIONTECH, 922649,WA,54.0,F,"Moderna COVID-19 vaccine Eua Headache, joint pain, muscle pain",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,OTH,None,None,None,,Sulfa,"['Arthralgia', 'Headache', 'Myalgia']",1,MODERNA,IM 922650,VA,,F,"Same day after getting the shot I developed chills. I came home from work and I took a shower and went to bed. Next day I woke up with nausea and headache. Later that day I had a nose bleed. The following day I was so weak, tired and dark urine. 12/24 I developed a fever of 101.0. I called my MD and made an appointment for 12/28 but I did not see her. I took Benadryl and Tylenol. 12/25 I woke and I felt better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,WRK,"tomoxifen, eloquist",no,covid 3/2020 brest cancer clotting disorder,,topramax,"['Asthenia', 'Chills', 'Chromaturia', 'Epistaxis', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 922652,NJ,53.0,F,"FEVER, BODY ACHES, AND FACIAL SWELLING started at 1200 on 01/06/2021. took 400 mg po motrin and 25 mg po bendaryl. At 4am took and additional 25 mg Benadryl po. and at 1000 took third dose of benadryl po 25 mg. Pt. states that he left eye is watering. Pt. states that she has a little bit of facial swelling still at 1023 am on 1/6/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,motrin 400 mg po lansoprazole 15 mg twice weekly,denies,GERD,,peanuts-hives,"['Lacrimation increased', 'Pain', 'Pyrexia', 'Swelling face']",2,PFIZER\BIONTECH,IM 922653,OH,29.0,U,TONGUE AND THROAT ITCHING : BENADRYL 25 MG PO X 1,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Throat irritation', 'Tongue pruritus']",1,MODERNA,IM 922655,TX,72.0,F,"Woke up at 3:00 am about 14 hours after the injection. Chills ,Fever 100.5 F, Heart Rate 95 ,Head Ache ,Fatigue ( fatigue malaise still present 01/06/2021 ) Upset stomach/pain. Took liquid gel Naproxen Sodium (OTC) 220 mg. 3 times, once an hour, fever and chills subsided temp at 8:00 am 98.8F. heart rate 85. General fatigue still present at the time of writing 01/06/2021 at 09:00. No appetite.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PHM,multi vitamines,none,prone to Bronchitis,,none,"['Abdominal discomfort', 'Abdominal pain upper', 'Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Malaise', 'Pyrexia']",1,MODERNA,SYR 922656,GA,83.0,M,"Moderna COVID- 19 Vaccine EUA No reaction reported until day 3 post vaccination. Patient reports a red rash that erupted over his upper body. He also reports itching and swelling at injection site. Patient was treated by his primary care physician with steroids. Rash still reported today, but he states it is improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/31/2020,3.0,PUB,,,,"Tetanus Toxoid Vaccine, unknown exact age, reports over 20 years ago. Patient reports that it is not the same vaccine in use now","Penicillins, Tetanus toxoid from original tetanus vaccine","['Injection site pruritus', 'Injection site swelling', 'Rash erythematous']",1,MODERNA,IM 922657,AR,17.0,F,Patient was vaccinated and is under the age of 18. No complications from being vaccinated at this time.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PHM,,,,,,['Product administered to patient of inappropriate age'],1,MODERNA,IM 922658,WI,56.0,F,Swollen lymph node started on (R) side of neck on 12/31/2020. Also has had neck and arm tenderness since day after injection (12/25/2020),Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/31/2020,7.0,PVT,"Acetaminophen (Tab) TYLENOL 500 MG Take 1,000 mg by mouth as needed. Cetirizine HCl (Tab) ZyrTEC 10 MG Take 10 mg by mouth once daily. Nexium 24hr",,Hyperlipidemia Asthma GERD (gastroesophageal reflux disease) Heart murmur,,None,"['Blood calcium', 'Blood lactate dehydrogenase', 'Differential white blood cell count', 'Full blood count', 'Lymphadenopathy', 'Tenderness']",1,MODERNA,IM 922659,GA,35.0,F,"Developed red splotchy rash on right ankle. Rash has spread to thighs, backs of legs, shoulder blades, arm pits and tops of the arms. Rash also itches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,SEN,"Wellburtrin, Prosac, Mobic, Vitamin C, Zinc",None,None,,Biaxin,"['Rash', 'Rash macular', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 922660,MO,31.0,M,"1/5/21 Within 10 min, started hot flash, right side of face was numb but was not paying attention and went to visit his wife and mother in hospital and came back to the clinic. Noted right facial swelling, right leg felt off, no blurred vison, no difficulty with swallowing. Staff walked to the ED. Gave Benadryl IM given, Steroid IM given. Discharged from ED about 1400",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,HCTZ,,,,Unknown diuretic,"['Hot flush', 'Hypoaesthesia', 'Limb discomfort', 'Swelling face']",1,PFIZER\BIONTECH,IM 922662,MD,39.0,M,"A few hours after injection, I began having discomfort in my left shoulder, the location of the injection. Over the following next few hours I began to have overall body aches and pains in my joints. My skin became extremely sensitive to the touch, a very strange hard to describe sensation. I then began to get the chills, and running a fever. Ultimately my fever spiked at 104 degrees. I took a cold bath to bring the fever down, and for the rest of the night seesawed back and forth with fever using cold compresses and no sheets on my bed to keep my fever down. I also took one 200 Mg Ib-Profen. At roughly 26 hours after the injection, I no longer have a fever, but the body aches persist.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,MIL,,,"Slightly Elevated Cholesterol, (not medicated or controlled)",,,"['Arthralgia', 'Chills', 'Injection site discomfort', 'Pain', 'Pyrexia', 'Sensitive skin']",2,PFIZER\BIONTECH,SYR 922663,TX,61.0,F,"First day after injection arm was extremely sore. That last just one day. about 5 days later injection site became very red, hard, warm to touch and extremely itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PUB,Olmesartan-HCTZ 40-25mg,None,controlled hypertension,,Sulfa drugs,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 922665,IN,65.0,F,"Received first vaccine 9:24 am. Went to observation area and was able to stand to schedule for second vaccine (less than 5 minutes after receiving vaccine and then went and sat down. About 10 minutes after vaccine given, patient became pretty dizzy. Was placed in a wheelchair for safety. BP 163/79 with HR 114. Started to improve in dizziness. Repeat BP 155/78 and HR 110 10 minutes later. Patient did eat breakfast and had 2 cups of caffeinated coffee this AM (usual amount). Patient recovered with no interventions.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,,,,,,['Dizziness'],1,MODERNA,IM 922666,NY,31.0,F,"Fever, chills, headache, muscle aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/02/2021,2.0,PVT,,,,,Lobster,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,SYR 922667,CT,38.0,F,"Large, raised area of itching, swelling. redness, heat, and mild pain around injection site. Began on 1/4, seven days after vaccination and continues now. Self-treating at home with cold packs and topical hydrocortisone.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,"metoprolol, bupropion, trazodone",none,"benign tachycardia, depression, anxiety",,none,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 922668,MI,60.0,F,"hypertension, dizziness - occurred ~15 minutes after her first dose; first BP was 166/81, second dose was 158/84; Taken to ED; outcome unknown",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,,,,,Sulfa,"['Dizziness', 'Hypertension']",1,PFIZER\BIONTECH,IM 922669,OH,46.0,F,Patient (myself) developed DVT/PE diagnosed on 1/4/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,01/04/2021,9.0,PVT,Metformin Birth Control Pills,None,Asthma,,Aspirin Anaprox Sulfa,"['Computerised tomogram thorax', 'Deep vein thrombosis', 'Pulmonary embolism', 'Ultrasound Doppler']",1,MODERNA,IM 922670,GA,68.0,F,"Within 24 hours of injection, the left arm became very red below the injection site, and after five days the redness had traveled down to the elbow. The arm was also distinctly warm to the touch and tender. During the first evening, I experienced chills and presumed fever that responded to 400 mg of Ibuprofen. I experienced some nausea, loss of appetite, and malaise over the next three to four days after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Plaquenil 200 mg po q day;,None,Rheumatoid Arthritis,tdap caused injection site tenderness,Codeine: Percocet: Morphine:,"['Chills', 'Decreased appetite', 'Injection site erythema', 'Malaise', 'Nausea', 'Pyrexia', 'Skin warm', 'Tenderness']",2,MODERNA,IM 922671,IA,36.0,F,"Patient reported itchy throat that seemed like it was closing. Given epi pen. In ED, given solumedrol and pepcid. Monitored for >3 hours and discharged to home with an additional epi pen as needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Pre-natal vitamins, vitamin supplements",None,,,"Dicloxacillin, Penicillins","['Throat irritation', 'Throat tightness']",1,MODERNA, 922672,KY,41.0,F,"2 days after the vaccine - flu like symptoms and low grade fever 4 days after - L armpit lymph node swollen and pain 6 days after - vaccine site redness, swollen, appeared like cellulitis. Large area of raised, warm and itchy and painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,PVT,,,,,Codeine,"['Influenza like illness', 'Injection site erythema', 'Injection site pruritus', 'Lymph node pain', 'Lymphadenopathy', 'Pyrexia', 'Vaccination site cellulitis', 'Vaccination site pain', 'Vaccination site swelling', 'Vaccination site warmth']",1,MODERNA,IM 922673,MN,67.0,F,"I woke up with tingling in my right hand and arm, my right side, and down my right leg. I went to the ER at Hospital, and was confirmed to have had a stroke in my left thalmus.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,12/19/2020,01/02/2021,14.0,WRK,"No prescription medications Dietary supplements: Vitamin D3, Magnesium, Essential Fatty Acids, Glucosamine and Chondroitin",None,None,,Doxycycline allergy,"['Angiogram', 'Blood test', 'Computerised tomogram', 'Computerised tomogram abdomen', 'Echocardiogram', 'Electrocardiogram', 'Lacunar stroke', 'Magnetic resonance imaging', 'Paraesthesia', 'Urine analysis']",UNK,PFIZER\BIONTECH,SYR 922674,FL,23.0,F,"1 week after vaccine, the site where I received the shot became a hive and my throat started to itch and become tight. I took 2 Benadryl that didn?t seem to calm the reactions. I went to the ER and received Famotidine and dexamethasone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,PVT,"Trazadone, lexapro, birth control",None,None,,Percocet,"['Injection site urticaria', 'Throat irritation', 'Throat tightness']",1,MODERNA,SYR 922675,,27.0,F,tenderness at injection site; mild swollen lymph nodes,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/22/2020,1.0,PVT,,,,,,"['Injection site pain', 'Lymphadenopathy']",UNK,PFIZER\BIONTECH, 922676,PA,30.0,F,"Palpitations, elevated heart rate. Red Face. Red upper chest. Complained of lightheadedness and pre-syncopal. HR radial 120 bpm, BP 145/91 with HR 111 with BP cuff. Able to be released, feeling better. Recheck of BP 137/84, HR 88 bpm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,WRK,Unknown,Unknown,Unknown,,Unknown,"['Dizziness', 'Erythema', 'Heart rate increased', 'Palpitations', 'Presyncope']",1,PFIZER\BIONTECH,IM 922677,NC,46.0,F,"Received the vaccine in morning: Started developing itching on torso throughout the day. On 1/6/2021 starting at 0500, the opposite arm (Right) developed tingling and numbness. Thumb is twitching.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,None,,,,None,"['Hypoaesthesia', 'Muscle twitching', 'Paraesthesia', 'Pruritus']",2,PFIZER\BIONTECH,IM 922678,OR,35.0,M,1/4/2021: swollen/hard inguinal lymph nodes (right and left side - harder on left side). Pain scale: 2 out of 10. Remained tender and swollen for 2 days. 1/6/2021: Significantly swollen axillary lymph node in left armpit. Discomfort. Pain scale: 2.5 out of 10. Tender and uncomfortable with arm up and down.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/06/2021,6.0,WRK,Fluoxetine Bupropion,None,Thalassemia,,Sulfa,"['Induration', 'Lymph node pain', 'Lymphadenopathy', 'Pain']",1,MODERNA,IM 922679,GA,68.0,F,"Within 24 hours of injection, the left arm became very red below the injection site, and after five days the redness had traveled down to the elbow. The arm was also distinctly warm to the touch and tender. During the first evening, I experienced chills and presumed fever that responded to 400 mg of Ibuprofen. I experienced some nausea, loss of appetite, and malaise over the next three to four days after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Plaquenil 200 mg po q day;,None,Rheumatoid Arthritis,tdap caused injection site tenderness,Codeine: Percocet: Morphine:,"['Chills', 'Decreased appetite', 'Increased tendency to bruise', 'Injection site erythema', 'Malaise', 'Nausea', 'Pyrexia', 'Skin warm']",2,MODERNA,IM 922680,AZ,48.0,F,At approximately 18:00 on 01/05/2021 I noticed my hearing was hypersensitive. At about 20:00 I experienced hearing loss in my left ear like I had an ear infection. This morning I woke up and it is worse. I can barely hear out of my ear and I have tinnitus. I am dizzy and feel cautious.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,UNK,None,None,Migraines,,"Sulfa, sunflower seeds","['Deafness unilateral', 'Dizziness', 'Ear infection', 'Hyperacusis', 'Tinnitus']",UNK,PFIZER\BIONTECH,IM 922681,MN,48.0,F,"left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at emergency room 1330 symptoms increased. airway not obstructed. No tongue swelling reported by MD. Light red rash/flushing on chest. 25mg IV benadryl administered. IV Solumedrol administered, Vital signs stable. Cardiac monitor: regular rate and rhythm. O2 saturations 98% on room air. Symptoms improving at 1345pm. Monitored in emergency room for 1 hour. Discharged in stable condition with instructions to repeat Benadryl 8 hours after first dose if needed Throat fullness ( left side) with mild difficulty swallowing continued. Headache 5pm. Left sided face fullness/tingling: jaw, cheek. Left eye: mild swelling. 25 mg Po Benadryl taken. 01/06/21 0800 AM symptoms Left sided facial fullness/tingling continues: mild. No difficulty breathing. Left eye mild/yet decreased puffiness continues.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,oxybutynin estradial multi vitamin ibuprofen tylenol,,,,nkda,"['Dysphagia', 'Ear discomfort', 'Eye swelling', 'Flushing', 'Headache', 'Nausea', 'Paraesthesia', 'Rash erythematous', 'Swelling face', 'Throat tightness']",1,PFIZER\BIONTECH,IM 922682,NC,23.0,F,"Patient experienced seizure-like symptoms. No limb movement, but eye fluttering and unconscious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,"Not medicated for seizures, no other meds reported",None reported on VAR or in verbal questionnaire,Reported seizures not being treated with medicine,,None reported on VAR other than latex,"['Eyelid disorder', 'Loss of consciousness', 'Seizure like phenomena']",1,MODERNA,IM 922683,NJ,24.0,F,Extreme soreness and pain in in arm near injection site. Unable to move arm the following day with difficulty 2 days post vaccine Fever Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,Lo loestrin Fe birth control,COVID 19 positive on December 5th,None,,None,"['Headache', 'Injected limb mobility decreased', 'Injection site pain', 'Pyrexia']",1,MODERNA,IM 922684,AR,60.0,F,"Itching, tingling and face swelling. Liquid Benadryl resolved the issue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PHM,,,,,,"['Paraesthesia', 'Pruritus', 'Swelling face']",1,MODERNA,IM 922685,,23.0,F,Knot in throat and lightheadedness hoarse.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,,,,,Gadobenate Dimeglumine (Gadolinium Contrast),"['Dizziness', 'Dysphonia', 'Nodule']",1,PFIZER\BIONTECH,IM 922686,CO,38.0,F,"Symptoms began around 6pm and gradually worsened? sneezing, runny nose, cough, sinus congestion, fever/chills, body aches (arthralgias, myalgia), headache, site injection pain (which was immediate upon injection, I bled- not a good administration), polyuria/difficulty sleeping overnight, I felt like I was very sick with the flu.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,None,None,None,Arm pain/neck pain,None,"['Arthralgia', 'Chills', 'Cough', 'Headache', 'Immediate post-injection reaction', 'Influenza like illness', 'Injection site haemorrhage', 'Injection site pain', 'Myalgia', 'Pain', 'Polyuria', 'Pyrexia', 'Rhinorrhoea', 'Sinus congestion', 'Sleep disorder', 'Sneezing']",2,PFIZER\BIONTECH,IM 922687,FL,47.0,F,"Within the first hour my left arm was already feeling sore. Within 6 hours I began ""not feeling good"", I felt hot, nauseous, coworkers reported me looking pale. swarmed with nurses giving me water, cold/wet towel, and temperature taken= afebrile. I was able to finish my shift. My body was aching and I felt as if I was ""coming down"" with something that night. By the next morning I felt nauseous, body aches, muscle tightness, chills, low grade fever, and fatigued. I took 1- 500mg acetaminophen and 400mg ibuprofen x 2 that day. My fever broke around 6pm on 01/02/2021. I had a good night sleep and felt fine the next day. I did have Covid over 5 months prior.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,"10mg celexa, 10mg zyrtec",None,None,,,"['Chills', 'Fatigue', 'Feeling abnormal', 'Feeling hot', 'Muscle tightness', 'Nausea', 'Pain', 'Pain in extremity', 'Pallor', 'Pyrexia']",1,MODERNA,IM 922688,CA,64.0,F,"Metallic taste in mouth, causing nausea. Symptoms subsided after approximately 15 mins.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,,,,,,"['Dysgeusia', 'Nausea']",1,MODERNA,IM 922689,TN,31.0,F,"I got my first dose of the Pfizer Covid vaccine on Saturday, 01/02/21, around 12:30 pm. About 12 hours after I got the vaccine (around 1 am), I woke up with a headache, chills, body aches and a low grade fever. During the night, my temp got up to 99.9 and continued to stay around mid to high 99s throughout the day on Sunday. I tried Tylenol without any success and kept going in and out of chills with body aches and headache persisting. Before I went to sleep Sunday (01/03/21) night, I switched to Ibuprofen and woke up Monday morning without a fever but still experiencing fatigue. Throughout the day on Monday, fever did not return. I stayed home from work on Sunday and Monday. On Tuesday 01/04/20, I was still tired but able to return to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,WRK,Multivitamin,,,,Sulfa antibiotics,"['Chills', 'Fatigue', 'Headache', 'Impaired work ability', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 922690,MA,30.0,F,Round red circle around vaccine site. Three inches in size. Itchy and feels warm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 922691,FL,55.0,F,"Severe body aches, headache, fever up to 102, chills, nausea, malaise. Identical symptoms to those I had when I had Covid 19. Symptoms improved by about 50% after 24 hours, 90% improved by 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,"Meloxicam, Synthroid, Atorvastatin, Duloxetine,",Covid 19 tested positive 12/11.,"Hypothyroid, hypercholesterolemia",,NKA,"['Chills', 'Headache', 'Malaise', 'Nausea', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 922692,VA,46.0,F,"Irritated around the vaccine area applied, a lot of itchy and when I touch fell like a cellulitis.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PUB,No,No,No,,No,"['Vaccination site induration', 'Vaccination site irritation']",1,MODERNA,IM 922693,TX,37.0,F,"Swollen, red, itching around day 5 post vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PUB,Multivitamin,None,None,,None,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA,IM 922694,MD,21.0,F,"hives all over on 12/29., body aches chills, fever 102. on 12/29/2020",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/29/2020,7.0,PVT,"spirilactone , for acne , Nexplanon implant birth control",,,,allergic to kiwi,"['Chills', 'Pain', 'Pyrexia', 'Urticaria']",1,PFIZER\BIONTECH,IM 922695,CO,26.0,F,"-Injection site pain 12 hrs later, pain severe 7/10, arm painful to light touch 18 hrs later: -Flushing/hot flashes throughout the day -Persistent headache lasting 24hrs -General fatigue All symptoms subsided after 48 hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,-Levora (OC) -MVI daily,none,Allergies,,none,"['Fatigue', 'Flushing', 'Headache', 'Hot flush', 'Injection site pain', 'Tenderness']",1,PFIZER\BIONTECH,IM 922696,,54.0,F,"I received the covid vaccine in my left arm yesterday morning at 8:00 am. I felt fine until noon when my arm became sore, which I expected to happen so I took Tylenol. By mid afternoon, my 4th and 5th finger on my left had began to tingle and I was having difficult typing with that hand on my keyboard. By late afternoon, the left side of my face began to tingle like paresthesia. I took more Tylenol at dinner but the sensation in my face lasted until I went to bed around 10:00. I woke up in the night and my face felt fine but my 2 fingers were still tingling and I felt like I had no control over them. When I woke up this morning, I took to more Tylenol and the symptoms have subsided. Also, when the nurse swabbed my arm with alcohol, I asked?Isn?t that a little high for the injection, and he said no?it?s right in the deltoid. It felt like the injection site was close to the bones in my shoulder but that may have had nothing to do with these symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,,,,,,"['Impaired work ability', 'Pain in extremity', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 922697,MA,70.0,F,Red circle at vaccine site. 2-3 inches. Itchy and warm feeling.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PVT,unknown,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 922698,AR,60.0,F,"Patient felt itching, tingling and swelling in her face. One dose of liquid Benadryl 25mg/10ml resolved the issue. No other complications",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PHM,,,,,,"['Paraesthesia', 'Pruritus', 'Swelling face']",UNK,MODERNA,IM 922700,MA,61.0,F,"Ee stated upon observation entrance, that she would be observed until 10:15am r/t ""anaphylaxis"" to Morphine. Informed us that she became ""itchy"" for ""3"" days prior to the 1st dose on 12-16-20. Ee c/o ""itching"" to this nurse @ 1005. Benadryl 25mg given @ 1005. Remains to c/o ""itching"" @ 1015. Ice pack applied to chest to relive itching @ 1015. Around 1025 Ee stated she felt ""relief of itching"". This nurse also gave Ee (1) Benadryl 25mg to take w. Her. Ee stated she was feeling better @ 1034. Left observation @ 1035.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,,,,,"Penicillins, Promethazine, Unasyn, Prochlorperazine Maleate",['Pruritus'],2,PFIZER\BIONTECH,IM 922701,NH,24.0,F,Swollen lymph node left armpit,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,PVT,"Montelukast, Sprintec birth control, Advair, ProAir",None,"Asthma, migraine",,None,['Lymphadenopathy'],1,MODERNA,IM 922702,CA,39.0,F,"Approximately 3 days after initial injection, experienced significant brain fog, aphasia, panic, headache, dropping things.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/31/2020,3.0,WRK,None,Iron-deficiency anemia,None known,,None,"['Aphasia', 'Feeling abnormal', 'Grip strength decreased', 'Headache', 'Panic reaction']",1,PFIZER\BIONTECH,IM 922703,FL,50.0,F,"redness, warmth and swelling with cellulitis appearance 6 days after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,PVT,"multivitamin, 1000mg vitamin C and pepcid 10 mg",none,none,,"morphine, adhesive tape","['Cellulitis', 'Erythema', 'Skin warm', 'Swelling']",1,MODERNA,IM 922704,IL,38.0,F,"Saturday, 2 days after I started having pain in the back of my throat and on my tongue. Not like a sore throat but pain then I noticed a small white bump on the back of my throat. The next day, Sunday I had small white bumps or blisters on the side and bottom of my tongue and the cheek of my mouth. These were painful. They started going away on Tuesday and by Wednesday 1/6/21 they were almost gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/02/2021,2.0,PUB,"Sprintec birth control, 25mg of Sertraline",none,none,,none,"['Glossodynia', 'Oral mucosal blistering', 'Oral mucosal eruption', 'Oropharyngeal pain', 'Rash', 'Tongue blistering', 'Tongue eruption']",2,MODERNA,SYR 922705,MT,35.0,F,"12 days following the vaccine administration I noticed redness on my arm around the injection site. This redness was hot to the touch and rather large, exceeding the deltoid muscle and going down into my bicep. I also felt radiating soreness into my armpit and left breast. The following day the rash had grown in size and felt hot to the touch on my entire upper arm with swelling and edema that affected the movement of my arm and hand. Continued soreness and pain in my armpit, left breast and down my arm into my fingers and up into my neck. I proceeded to go to the urgent care as directed by Clinic employee health and my PCP. There was I was diagnosed with cellulitis and prescriped Keflex for 7 days, 3x a day. It has been recommended that I seek further medical care due to my reaction, but this has yet to be scheduled.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/05/2021,13.0,PVT,Ortho-Cyclen 0.25mg Fish Oil Multivitamin Probiotic Magnesium,none,none,,none,"['Axillary pain', 'Breast pain', 'Cellulitis', 'Injected limb mobility decreased', 'Injection site erythema', 'Injection site rash', 'Injection site warmth', 'Neck pain', 'Oedema peripheral', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,SYR 922706,PA,30.0,U,Patient c/o palpitations. Elevated HR. Red Face. Red Upper Chest. Lightheadedness and presyncopal. HR initially 120 bpm; BP 145/91 Observed for 40 minutes. Able to be released. Feeling better after monitoring. BP recheck 137/84; HR 88 bpm,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,WRK,Unknown,Unknown,Unknown,,Unknown,"['Dizziness', 'Erythema', 'Heart rate increased', 'Palpitations', 'Presyncope']",1,PFIZER\BIONTECH,IM 922707,,28.0,M,"Moderna COVID-19 Vaccine EUA Day 1 just local injection site pain, no treatment. Day 2 local injection site pain, body aches x 24 hours, chills x 24 hour. No treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,UNK,,,,,,"['Chills', 'Injection site pain', 'Pain']",1,MODERNA,IM 922708,VA,32.0,F,"On 1/5/20 developed swelling and soreness, on 1/6/20 noticed that arm is red, mildly itchy, swollen, sore, and indurated.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,,anaphylactic reaction to rat bite,"Migraine, overweight",,"No allergies to medications, food, or products. Only environmental allergens.","['Erythema', 'Induration', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Swelling']",1,MODERNA,IM 922709,AR,39.0,F,Patient felt itchy. One dose of liquid benadryl 25mg/10ml resolved the issue.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PHM,,,,,,['Pruritus'],1,MODERNA,IM 922710,NY,32.0,M,Rash appeared and was noticed the morning after. Round red patch in appearance. Resolved by day 3.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,PVT,NO,No,None,,No,['Rash erythematous'],1,PFIZER\BIONTECH,IM 922711,NM,33.0,M,"Sore arm, chest pain, back pain runny nose and cough",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/04/2021,4.0,PUB,None,None,Obesity,,None,"['Back pain', 'Chest pain', 'Cough', 'Pain in extremity', 'Rhinorrhoea']",UNK,MODERNA,IM 922712,VA,53.0,F,Developed a rash on the right arm where the injection site was.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,"hydroxine, trazodone, Alprazolam",none,none,,"sulfa, poison oak and ivy",['Injection site rash'],1,MODERNA,IM 922714,MS,51.0,F,Chills,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/05/2021,5.0,UNK,Vitamin C Vitamin D Zinc Multiple Vitamin,None,None,,None,['Chills'],1,MODERNA,IM 922715,OH,38.0,F,"Received Vaccine 12/23/20 (Weds) at 12:30pm, in left upper arm. Severe (Vice-Like) headache in back of head 5 minutes after, lasted til next morning. Lots of Sneezing over weekend on days 2-4; Monday 12/28- woke at 4a and was extremely dizzy and almost lost balance-went back to bed. Again at 5a and 10am but added vomiting along with any movement, could only lie flat on back, any movement of head caused reaction. No taste when vomiting, minimal smell; came back later in day. Advised to go to ER for Covid Test, since I had worked closely with someone else positive the previous week. Husband had to call an ambulance when I couldn?t make it out of the bedroom due to weakness, true vertigo-room was completely spinning and couldn?t keep my balance, and severe vomiting with any upright movement. Covid test negative. ER diagnosed as BPPvertigo because no other outright viral symptoms; only sneezing before; but they noted fluid in my left ear- said wasn?t infected. Told them of headache in back left rear of head, behind ear, and pressure behind left eye. Positive Dix-Hallpike;nystagmus. Vertigo continued, even with medication through Thursday 12/31/20 and turned to dizziness that subsided by Saturday 1/2/21. Weds 12/30/20- severe left ear pressure, feeling of fullness; focal pain/headache in bone behind left ear began, and pressure behind left eye increased. Low grade fever 1/2/21-1/4/21 (99.9). Seen by ENT on 1/4/21 due to continuing symptoms; and was misdiagnosed originally by ER- diagnosed by ENT as Acute Viral Labyrinthitis and Vestibular Neuritis. As of 1/6/2021- symptoms continue. *suspected recovered from Covid March 2020",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,Vyvanse 70mg; Linzess 75 mg,None,IBS,,None,"['Ageusia', 'Asthenia', 'Audiogram', 'Balance disorder', 'Dizziness', 'Ear discomfort', 'Exposure to SARS-CoV-2', 'Headache', 'Hyposmia', 'Middle ear effusion', 'Nystagmus', 'Ocular discomfort', 'Pyrexia', 'SARS-CoV-2 test negative', 'Sneezing', 'Vertigo', 'Vertigo positional', 'Vestibular neuronitis', 'Viral labyrinthitis', 'Vomiting']",1,MODERNA,IM 922716,IL,30.0,F,"Pain in site of injection, malaise, chills, retro orbital pain for approximately 24h.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Levothyroxine 100 mcg,No,Hypothyroidism,,No,"['Chills', 'Eye pain', 'Injection site pain', 'Malaise']",2,PFIZER\BIONTECH,IM 922718,WI,26.0,M,"Immediately after vaccine administration, patient reported he felt faint. Had flushed cheeks and increased blood pressure. Had patient recline and was monitored for 20 minutes and felt better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,,,,,,"['Blood pressure increased', 'Dizziness', 'Flushing', 'Immediate post-injection reaction']",1,PFIZER\BIONTECH,IM 922719,CA,48.0,F,Swollen Redish brown color at site itching swelling has gotten the size of her hand,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/31/2020,3.0,UNK,,,,,,"['Injection site discolouration', 'Injection site swelling', 'Pruritus', 'Swelling']",1,MODERNA,SYR 922720,MS,49.0,F,"Body Aches, Fever, Chills, Muscle Pain, Joint Pain, Severe Headache, Severe Fatigue. redness and swelling t injection site Severe Nausea, Face feels like its on Fire.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,None,None,None,,Pencillin,"['Arthralgia', 'Burning sensation', 'Chills', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site swelling', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia']",UNK,MODERNA, 922721,AZ,37.0,F,"At minute 12 after injection (8:31am on 1/5/20), the pruritis started on my scalp and my back. I informed the volunteer at the end of the drive line. She offered to have EMS evaluate me, however I declined as I thought the reaction was mild. Over the next 10 minutes, after being released from the driveline, I was so itchy I wanted to literally rip all of my skin off. The back of my throat started to itch, but never felt tight or swollen. No SOB or chest tightness. I checked my temp at 8:45 and I was at 101.0 and HR was 110bpm. I am a PA working in dermatology and got to work and took 50mg of diphenhydramine PO but was not improving. One of the doctors I work with and I decided it was best for me to get checked out in urgent care. I had my MA drive me there and was seen immediately. I had a blotchy rash over my entire body, but not raised or hived. Temp was 100.6, HR 86 and BP 127/78, respirations 16/min O2 sat 98% and the itchiness was still severe but I could tell the diphenhydramine was kicking in. I was then given 40mg of famotidine PO and 10mg Dexamethasone IM in the right buttocks while in urgent care. After about 15 minutes, my symptoms were improving, but not resolved. I was released and went home to rest. Throughout the day yesterday (1/5/20) my heart rate would spike as high as 130bmp (my normal is 60-70bpm). Then it would come down within a few seconds to about 100bpm and steadily stay between 90-100bpm all day. Last night I was woken up at 3:30am (1/6/20) with a HR of 132bpm and O2 at 97%. I took a few deep breaths, and it slowly started to drop to 100bpm. Since 6:00am, I am steady at 70-80bpm with occasional spikes of 96-100bpm and I can feel when my heart is starting to race. I have my pulse ox on for the day and will continue to monitor my symptoms. I still have occasional pruritis, but it's tolerable. I was discharged from urgent care with PO Prednisone tapered dose, however, I am very shaky already and do not want to make it worse, so have not started it yet. Not sure if I should? And I would like to know if I should receive the second dose? If so, should I pre-medicate? Please let me know if you have any further questions about my event. Thanks.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,none,none,none,,apples; amoxicillin,"['Body temperature increased', 'Heart rate increased', 'Palpitations', 'Pruritus', 'Rash', 'Rash macular', 'Sleep disorder', 'Throat irritation', 'Tremor']",1,MODERNA,IM 922722,WA,41.0,F,"Painful/swollen/firmness x 1 week, red/itchy starting day 7, diffuse redness day 8, resolved day 9",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,PVT,"Synthroid , bcp, mirena, calcium, vit. C, vit. D, dhea, DIM,",None,"Hypothyroid, endometriosis",,Erythromycin,"['Erythema', 'Induration', 'Pain', 'Pruritus', 'Swelling']",1,MODERNA,IM 922723,FL,59.0,F,Numbness/tingling in fingers/hand approx 5 min after injection; pain in wrist approx 10 minutes after injection which has extended into hand 48 hours after injection,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,WRK,Vitamin D3 81 mg aspirin esomeprazole,,Horners Syndrome,Numbness/Tingling of fingers/hand & wrist pain; age 59; 12/18/2020; Pfizer\BioNTech Covid 19 1st dose,Penicillins Amoxicillin-Pot Clavulanate Moxifloxacin Hcl Erythromycin Base,"['Arthralgia', 'Hypoaesthesia', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 922724,NE,44.0,F,"tender, swollen lymph nodes left clavicle area noticed 5 days following injection 1/5/21 only experienced sore lt arm 1st 24 hrs of injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,PVT,Aleve prn daily multi vitamin,none,none,,none,"['Lymphadenopathy', 'Pain in extremity', 'Tenderness']",1,MODERNA,IM 922727,PA,46.0,F,"states 40 minutes after her vaccine she developed facial parasthesias and numbness that eventually resulted in an ""ache"". No muscle weakness. This has since improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Hypoaesthesia', 'Pain', 'Paraesthesia']",1,PFIZER\BIONTECH, 922728,IL,26.0,M,Pain at the injection site. Pain abolished within 48 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,None.,None.,none,,None.,['Injection site pain'],1,MODERNA,IM 922729,MN,65.0,F,"Muscle aches at site and other parts of my body,chills and very tired and just felt like I had a virus but just for one day,felt back to normal the next day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,"Multivitamin,fish oil,calcium,glocosomine,red yeast rice",My husband was positive for covid around 11/25 and a week later i had symptoms of muscle pain and some exhaustion for a couple of days but always tested negative,None,,None,"['Chills', 'Fatigue', 'Injection site pain', 'Myalgia']",1,MODERNA,SYR 922730,MD,41.0,F,Employee received the Pfizer vaccine for the initial dose which was 12/17/2020 and received Moderna for the second dose on 1/5/202. Employee has had no side effects,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,none,,,,none,"['Interchange of vaccine products', 'No adverse event']",1,PFIZER\BIONTECH,IM 922731,LA,73.0,F,"The patient completed her 15 minute observation with no post injection reaction. At 1:15 pm, the patient called complaining of right eye drooping, right facial tingling, mild shortness of breath, facial flushing and new onset headache. She arrived at ED at 2:06 pm presenting with facial swelling, tingling and shortness of breath. At that time, she stated her shortness of breath had actually improved and stated ""probably just nerves"". She still had a funny sensation in her face. She denied any focal numbness or weakness in her extremities. She stated she felt a little lightheaded. She had no sensation of throat swelling, difficulty swallowing. Physical Exam in ED: Constitutional: She appears well-developed and well-nourished. HENT: Head: Normocephalic and atraumatic. Eyes: EOM are normal. Neck: Normal range of motion. Cardiovascular: Normal rate and regular rhythm. Pulmonary/Chest: Breath sounds normal. No respiratory distress. Abdominal: Soft. There is no abdominal tenderness. Musculoskeletal: Normal range of motion. Neurological: She is alert and oriented to person, place, and time. Patient has symmetric facial numbness, she has right periorbital swelling causing what appears to be a facial droop however her mouth seems symmetric, she has negative Romberg's, she has full strength and symmetric sensation throughout Skin: Skin is warm and dry. Psychiatric: She has a normal mood and affect.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,,,"Past Medical History Acute gout of left foot 7/5/2017 o CHF (congestive heart failure) o Coronary artery disease x 3 stents- last one 2012 o Coronary artery disease o Encounter for blood transfusion o Facial hematoma 5/31/2019 o GERD (gastroesophageal reflux disease) o History of sepsis 01/2020 o Hypercholesterolemia o Hyperlipidemia o Hypertension o Morbid obesity with BMI of 40.0-44.9, adult 9/3/2015 o Pain and swelling of left shoulder 8/24/2016 o Person injured in nonmotor-vehicle nontraffic accident 1/24/2012 o PONV (postoperative nausea and vomiting) o Post concussive syndrome 5/31/2019 o Reflux o Sleep apnea with use of continuous positive airway pressure (CPAP) o Strain of tendon of left rotator cuff 7/14/2016 o Symptomatic anemia",,"Allergen: Response to Allergen Iodinated Contrast Media :Not Specified Codeine Low Itching:Rash Dilaudid [hydromorphone]: Low Itching, Rash Keflex [cephalexin]: Low Itching, Rash Lyrica [pregabalin]: Low Rash Morpholine Analogues: Low Itching, Rash, Hallucinations Penicillins: Low Itching, Rash Percocet [oxycodone-acetaminophen]: Low Itching, Rash Percodan [oxycodone Hcl-oxycodone-asa]: Low Itching, Rash Sulfa (sulfonamide Antibiotics): Low Itching, Rash Tramadol:Low Itching, Rash Vicodin [hydrocodone-acetaminophen]:Low Itching, Rash Zoster Vaccine Live (pf): Low Rash","['Dizziness', 'Dyspnoea', 'Eyelid ptosis', 'Facial discomfort', 'Facial paralysis', 'Flushing', 'Headache', 'Hypoaesthesia', 'Paraesthesia', 'Periorbital swelling', 'Romberg test', 'Swelling face']",1,PFIZER\BIONTECH,IM 922732,IL,50.0,F,"CHILLS, FEVER, HEADACHE, DIZZINESS, UPSET STOMACH",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,NONE,NONE,NONE,,NONE,"['Abdominal discomfort', 'Chills', 'Dizziness', 'Headache', 'Pyrexia']",1,MODERNA,IM 922733,MA,43.0,M,"Employee received the Moderna vaccine in the left arm and noted numbness in the left finger tips approximately 20 minutes later. RN assessed patient and patient requested additional assessment by our Medical Assistance Team (MAT). The MAT team transferred the patient to the Emergency Department for further care. Patient released from ED. Contacted the following day and stated he had an elevated heart rate in the ED and when it returned to normal, they released him with instructions to follow up with his PCP if the arm pain and tingling did not subside in 1-2 days. He states his left shoulder is painful today (1/6/21 10:00 am) and his left fingers are still tingling. Patient instructed to call Occupational Health for further guidance.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Unknown,Unknown,Unknown,,None reported,"['Heart rate increased', 'Hypoaesthesia', 'Injection site pain', 'Pain in extremity', 'Paraesthesia']",1,MODERNA,IM 922734,GA,55.0,F,"Fever, headache, joint pain, muscle pain, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Metformin, zoloft, enalapril, crestor daily",None,"Hypertension, diabetic type 2, depression, high cholesterol",,Penicillin,"['Arthralgia', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,ID 922735,MI,22.0,F,"Chills/cold sweats, headache, fatigue, extreme soreness at injection site, body aches and pains",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Lexapro, acyclovir, Junel, and Zyrtec",None,None,,None,"['Chills', 'Cold sweat', 'Fatigue', 'Headache', 'Injection site pain', 'Pain']",UNK,PFIZER\BIONTECH,SYR 922736,SD,61.0,F,body aches - 1 hour after 6:10 pm vaccination for several hours. None by the next morning.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,sudafed,,obese,,"amoxicillin, penicillin",['Pain'],1,MODERNA,SYR 922737,TN,47.0,F,"soreness and swelling at injection site in small area, chills, and headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,OTH,"Nexium, Aleve, Cymbalta, Claritin, Multi-vitamin for Women, birth control pill, CBD oil, Flonase, Plaquinil, and fiber supplements.",None,Sjogren's Syndrome and acid reflux.,,"I'm only allergic to pollen, dust, and dander.","['Chills', 'Headache', 'Injection site pain', 'Injection site swelling']",2,PFIZER\BIONTECH,IM 922738,NY,54.0,F,"Severe pain, swelling, heat at site. Low grade fever, chills, fatigue for 2 days thus far.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Synthroid, edarbi","HTN, Hypothyroidism","ITP, Mitral valve regurgitation",,Sulfa drugs,"['Chills', 'Fatigue', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Pyrexia']",1,MODERNA,IM 922739,MA,46.0,F,"AFTER ADMINISTRATION OF 1ST DOSE MODERNA, PATIENT FELT FLUSHED THEN SOB AND TACHYCARDIC. PT WAS MADE SUPINE AND PROMPTED TO TAKE SLOW DEAP BREATHS; BP CHECKED 180/90, RECHECKED 176/87, RECHECKED 139/80. LAST BP CHECK 129/75. HR INITICLALLY 106 THEN NORMALIZED IN THE 80S. O2 WAS CONSISTANTLY AT 100%. PATIENT WAS MONITORED FOR 30 MINS, WAS OFFERED TO BE TRANSPORTED TO ED. PT DECIDED SHE WAS GOOD TO GO HOME. NO OTHER SIGNIFICANT SYMPTOMS NOTED- NEGATIVE FOR SWELLING, RASH, HIVES.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Unknown,Unknown,Unknown,,NKDA,"['Dyspnoea', 'Flushing', 'Tachycardia']",1,MODERNA,IM 922740,MA,79.0,M,"The next day, around noon time. reported increased malaise. That evening temp of 101.1 with increased fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,Unknown,None,Unknown,,Unknown,"['Body temperature increased', 'Fatigue', 'Malaise']",1,MODERNA,IM 922741,NE,43.0,F,swollen and reddened area surrounding injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,none,none,none,,,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,SYR 922742,NE,47.0,M,"Fever (102.6' @ 0800 12-24-20), Body ache, Injection site pain, chills, fatigue, slight headache. Lasting until early morning hours of 12-25-20.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 922744,NJ,45.0,M,I experienced flushing with fever and chills starting the evening of the 4th and ending on the morning of the 6th,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Humalog, pravastatin",,Diabetes,,NKA,"['Chills', 'Flushing', 'Pyrexia']",1,MODERNA,IM 922747,NY,42.0,M,-Chills -Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,none,none,"Obesity, Obstructive sleep apnea",,none,"['Chills', 'Fatigue']",1,MODERNA,IM 922748,SD,35.0,F,"Left shoulder pain, itching and swelling starting a week after vaccination. Treated with ibuprofen and diphenhydramine. Symptoms ongoing as of today 1/6/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PUB,Citalopram 10mg,,,,Raglan,"['Arthralgia', 'Pruritus', 'Swelling']",1,MODERNA,IM 922749,NJ,29.0,F,"Weakness, fatigue, body aches, injection site soreness/became hot, fever rushes, lack of appetite, sinus pressure, post nasal drip",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,CVS Health D3 (50mcg) One A Day Women's Complete Multivitamin,,,,Carrots Celery Watermelon,"['Asthenia', 'Decreased appetite', 'Fatigue', 'Injection site pain', 'Injection site warmth', 'Pain', 'Paranasal sinus discomfort', 'Pyrexia', 'Upper-airway cough syndrome']",1,MODERNA,IM 922750,IN,77.0,F,Patient c/o itching and hives that evening and went to bed. Patient states she took a Zyrtec home dose. Patient denies any trouble breathing. Associate states she came to hospital to report the event just in case. Patient states the itching and hives have resolved at this time.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,none,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 922751,OR,42.0,F,itching at the injection site then a red rash at the injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,,,,,,"['Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 922752,LA,74.0,F,"Headache, sore arm, vomiting, diarrhea, chills Took injection @ approx. 10:45 am on 1/4/21; symptoms started about 3:30pm and lasted from 6-8 hrs. Headache & sore arm lingering on 1/6/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Morning: (didn't take 1/4/21) Metaprolol Tartrate, Digoxin, Levothyroxine, AReds2 Evening: Montelukast, Ibuprofin PM, Vitamin D, Atorvastatin, Magnesium",Had D&C on 12/16/20 for removal of vaginal polyp,Atrial fibrillation (arrhythmia); reverse shoulder replacement in rt arm approx. 5 yrs ago; double hernia repair 30 yrs ago; L5S4 fusion about 25 yrs ago.,,Codeine,"['Chills', 'Diarrhoea', 'Headache', 'Pain in extremity', 'Vomiting']",1,PFIZER\BIONTECH,SYR 922753,AL,47.0,F,"Had a ""histamine reaction"" - Nose, mouth, eyes started itching and watery - all within 1.5 hours of receiving the vaccine. This resolved the next day except itching in sensitive areas (lips, nose, eyes, folds of skins, behind ears, inside ears). Patient started taking Pepcid and Zyrtec twice a day. The symptoms resolved with this treatment through 2/4/21. All symptoms resolved as of 2/6/21. She is taking Pepcid once a day. Never had any redness, rash, bumps at all - just itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Ortho-Tricycline daily Lexapro 10 mg daily Xyzal 5 mg daily,None,None,,Flouroquinolones (Levaquin and Cipor),"['Eye pruritus', 'Histamine intolerance', 'Lacrimation increased', 'Nasal pruritus', 'Oral pruritus', 'Pruritus']",1,MODERNA,IM 922754,AZ,33.0,M,Patient received Moderna vaccine instead of Pfizer vaccine for dose #2 in vaccine series of COVID-19 vaccine series.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,,,,,,['SARS-CoV-2 antibody test'],2,MODERNA,IM 922755,CA,48.0,M,Staring about 12 hours after the injection and persisting at least 12 hours (current time) I have mild disequilibrium such as I just stepped off a merry-go-round. It is not frank vertigo and does not impair my ability to walk or drive but is noticible.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,Adderral,None,None,,None,['Balance disorder'],1,MODERNA,IM 922756,PA,30.0,F,Local injection site reaction Red Warm Raised Hard Itchy,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/03/2021,6.0,UNK,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA, 922757,,22.0,M,Redness and pain at injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,MIL,,,,,,"['Injection site erythema', 'Injection site pain']",1,MODERNA,IM 922758,AR,25.0,F,"Woke up at 1230 am with chills, headache and mild dry cough and we too tired to get up to take my temperature and take Tylenol. I woke up again at 3:50am with chills and aches and this time got up to take my temperature- oral temp 100.9. Took Tylenol shortly after and the fever came down to 98.9. Still achy and fatigued.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Nature?s bounty women?s multivitamin gummies,None,Seasonal allergies,,None,"['Chills', 'Cough', 'Fatigue', 'Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,IM 922760,NC,41.0,F,Hives and itching 1 hour after receiving vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,MIL,"20 mg Zyrtec qd, 25 mg Benadryl at bed time, Sythroid 75mcg every other day 50 mcg every other day opposite of 75mcg, doxycycline qd",sulfa drugs,hashimoto disease autoimmune urticaria,hives and itching,,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 922761,MA,90.0,M,"Lethargy, chills, shaking, pale, slightly tachycardic. Afebrile initially then fever presented after about an hour to 103.3",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,SEN,"Flomax, Multivitamin with minerals, tylenol, Carbidopa-Lecodopa, Senokot, Pramioexole Dihydrochloride, Fesoterodine Fumarate ER, Mesalamine ER, Omeprazole, Miralax powder, Melatonin, Bengay cream, Aspririn, Clonazepam, Levothyroxine, Cardiz",Recently positive for COVID-19,"Parkinson's, BPH, weakness, dysarthria, dysphagia, restless leg syndrome, anemia, ulcerative colitis, barrett's esophagus, HTN, dementia, hypothyroidism, anxiety disorder, UTI,",,"Lisinopril, Metoclopramide, Penicillin","['Blood culture negative', 'Blood lactic acid normal', 'COVID-19', 'Chest X-ray abnormal', 'Chills', 'Lethargy', 'Pallor', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test positive', 'Tachycardia', 'Tremor', 'Urine analysis normal']",1,PFIZER\BIONTECH,IM 922762,MD,41.0,F,Employee received two different kinds of vaccine for the 2 series. Pfizer for the initial dose and Moderna for the second dose,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,,['Interchange of vaccine products'],1,PFIZER\BIONTECH,IM 922763,TX,55.0,M,"The injection site swollen with significant pain, and developed skin rash on the backside of both upper arms (no itch or any other feeling of those rashes).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,,I always had a fever for a day or two after my annual flu shot.,I have seasonal allergies to pollen and weed.,"['Injection site pain', 'Injection site swelling', 'Rash']",UNK,MODERNA, 922764,NY,41.0,F,"cc: L upper arm pain 8 days post Moderna vaccine received. with swelling, redness. Cold compress applied yesterday. Took advil 200 mg po last night and Claritin 10 mg po last night.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,01/03/2021,8.0,WRK,atorvastatin 10mg QD; OCP,none,hyperlipidemia,,NKA,"['Erythema', 'Pain in extremity', 'Swelling']",1,MODERNA,IM 922765,NJ,25.0,F,"Rash/hives to face, neck, arms. Minimal face swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,Larissa birth control,None,None,,None,"['Rash', 'Swelling face', 'Urticaria']",1,PFIZER\BIONTECH,IM 922767,TN,87.0,F,Patient woke on 1/3/2021 weak having uncontroled bowels and off and on confusion.,Not Reported,,Not Reported,Yes,,Not Reported,N,01/02/2021,01/03/2021,1.0,PUB,unknown,unknown,unknown,,unknown,"['Anal incontinence', 'Asthenia', 'Confusional state']",1,MODERNA,IM 922768,TX,51.0,M,"24 hours of fever, chills, aches, shooting pains in the ears, headache, fatigue. Fever not relieved by Tylenol or ibuprofen. Temp to 101F. Given a course of prednisone by urgent care provider which stopped the symptoms after the first dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,,Covid-19 documented infection on 12/12/20 and also on 12/31/20 from PCR test. Symptoms had resolved by the time of vaccination,,,Aspirin,"['Chills', 'Ear pain', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 922769,TN,44.0,F,"hematoma, redness, warmth, and pain at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/06/2021,9.0,PHM,unknown,no,no,,no know drug allergies,"['Injection site erythema', 'Injection site haematoma', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 922770,,46.0,F,Seven days after injection 2.5 x 3.5 inch red swollen area appeared on left arm at injection site with intermittent intense itching,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,WRK,Lexpro,,,,,"['Injection site erythema', 'Injection site swelling', 'Pruritus']",1,MODERNA,IM 922771,FL,48.0,F,"?Moderna COVID-19 Vaccine EUA? side effects experienced are fever, vomiting, body aches, soreness and swelling of injection site, swollen glands in neck, enhanced pain in areas currently being treated for injury.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"lisinopril, metoprolol,",Covid 19 from approx 11/15/20 to 12/01/20.,"thyroid, hypertension, heart murmur, anxiety, alcoholism",,,"['Injection site pain', 'Injection site swelling', 'Lymphadenopathy', 'Pain', 'Pyrexia', 'Vomiting']",1,MODERNA,SYR 922782,MA,,U,"shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in or around 2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance and for its intended purpose: the prevention of shingles (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided). On an unknown date (reported as shortly after receiving the vaccine), the patient suffered shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient condition. In addition, the patient sustained severe and permanent personal injuries. Further, the patient had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was not recovered. The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was assessed as related. Herpes zoster was considered a disabling event by the reporter.",Not Reported,,Not Reported,Not Reported,,Yes,N,,,,UNK,,Routine health maintenance,,,,['Herpes zoster'],UNK,MERCK & CO. INC.,OT 922789,MA,47.0,F,The patient developed a very short episode of flushing a few minutes after administration of the vaccine. About 30 mins after the vaccine she developed significant nausea without vomiting. She was administered Zofran with no relief. She was monitored for an additional 90 mins with no resolution of symptoms and could not function and was sent to emergency room and given Phenergan with eventual resolution of symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/01/2021,01/01/2021,0.0,PVT,,,,,,"['Flushing', 'Loss of personal independence in daily activities', 'Nausea']",1,MODERNA,IM 922790,PA,57.0,M,Extreme sweating through the night. Woke up just about every hour on the hour sweating. No noticeable fever just sweating. Soreness at injection site but no more than to be expected.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Janumet 1000mg, Simvastatin 20mg. Jardiance 25mg",None,"Diabetes, High Cholesterol",,None,"['Hyperhidrosis', 'Injection site pain', 'Night sweats', 'Sleep disorder']",2,MODERNA,SYR 922791,AR,45.0,F,Swelling and pain at injection site for several hours after receiving allergy shot,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/04/2021,6.0,PHM,"Adderall, bupropion, singular, zyrtec",,,,Year round indoor and outdoor allergies,"['Injection site pain', 'Injection site swelling']",1,MODERNA,SYR 922792,MO,50.0,F,HEADACHE ONSET 12-31-2020 AND IS STILL ONGOING,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,,,,,,['Headache'],2,MODERNA,IM 922793,NY,26.0,F,"Woke up at 0400hrs with a temperature of 99.7, body wide pain, exhaustion, and a headache. Fever reached 100.00 by 0530hrs. Fever subsided by 1200hrs. Slept majority of the day. Symptoms went away around 1730hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,PVT,Birth Control (oral),Covid positive diagnosis on 12/13/2020. No symptoms after 12/22/2020.,None,,Tree nut allergy,"['Fatigue', 'Headache', 'Pain', 'Pyrexia', 'Somnolence']",1,PFIZER\BIONTECH,IM 922794,OH,69.0,F,"Soreness in the arm started later on the same day (late evening on 12-30-20). Woke up at 5:00 am the next morning (12-31-20)with severe chills, headache and dizziness. Felt as if I had covid all over again (was diagnosed with covid on October 12, 2020). My whole body ached and I was extremely fatigued. All I wanted to do was sleep and I also started a slight cough. Later on in the afternoon I started to sweat profusely. I had chills/sweats all through the afternoon and into the evening. I did not even get out out bed until the next afternoon (1-1-21). For 2 days afterwards I had chills/sweats and on 1-2-21 I had terrible stomach cramps and diarrhea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,SEN,"synthroidemetformin,atenolol,furosemide, losartan, glipizide",no,"high blood pressure, hypothyrodism, diabetes",,no,"['Abdominal pain upper', 'Chills', 'Cough', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Pain', 'Pain in extremity', 'Somnolence']",1,PFIZER\BIONTECH,IM 922795,PA,68.0,F,"Left arm pain, muscle ache (severe) for two days after injection One week after injection, swelling of lymph nodes under left arm (injection arm), painful to touch, extremely uncomfortable. So far, three days, ongoing. Physician office visit not necessary at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PVT,"Vitamin D, B-12",,"Osteo-arthritis, Graves Disease (in remission)",,Levaquin,"['Discomfort', 'Injection site pain', 'Lymphadenopathy', 'Myalgia', 'Pain in extremity']",1,MODERNA,IM 922796,TX,35.0,F,"Coughing,chest pain, congestion, trouble breathing",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,None,None,Bronchitis,,None,"['Chest pain', 'Cough', 'Dyspnoea', 'Respiratory tract congestion']",UNK,MODERNA, 922797,NE,32.0,F,"left side tingling and numbness, decrease BP and pulse, nausea, dizziness/lightheaded, difficulty answering questions, itchy-allergic to benadryl so sent to ER for further evaluation",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,benadryl,"['Blood pressure decreased', 'Communication disorder', 'Dizziness', 'Heart rate decreased', 'Hypoaesthesia', 'Nausea', 'Paraesthesia', 'Pruritus']",1,PFIZER\BIONTECH,IM 922798,TX,65.0,F,"dizziness, tachycardia, feeling of impending doom, lightheaded feeling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,"Nexium, Carafate, Myerbetrig, Metoprolol, Doxepin, Vit D, Methotrexate, Folic acid","rheumatoid arthritis, fibromyalgia, osteoporosis, GERD, irregular tachycardia, possible atrial fibrillation","rheumatoid arthritis, fibromyalgia, osteoporosis, GERD, irregular tachycardia, possible atrial fibrillation",,"sulfa, skelaxin","['Anxiety', 'Dizziness', 'Tachycardia']",1,PFIZER\BIONTECH,IM 922799,MI,57.0,F,"nausea, diarrhea, vomit x 1, low grade fever 10 days after vaccine given",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/03/2021,10.0,PVT,atorvastatin 20mg daily,,increased calcium in arteries per CT scan,,sulfa,"['Diarrhoea', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 922800,MA,32.0,F,"The reaction I have now is its swollen face and neck area, rashes all over my body all very itchy skin. Those are very manageable reactions. and happened exactly a week from the first dose of the vaccine. It has been going on for 2 days now and I will be seeing my doctor later today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,WRK,Vitamin c - Biotin - Vitamin d 2000,controlled LUPUS,controlled LUPUS,,,"['Pruritus', 'Rash', 'Swelling', 'Swelling face']",1,PFIZER\BIONTECH,IM 922801,MT,27.0,M,"The symptoms arose the day following the injection. Vaccine received 04Jan21. All of the following occured around the same time (7:30pm) except for the headache: Headache (around 11:30am is when this settled in), fatigue, body aches and chills, slight loss of taste.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,MIL,,,,,,"['Ageusia', 'Chills', 'Fatigue', 'Headache', 'Pain']",1,MODERNA,SYR 922802,OK,49.0,F,"Night sweats followed by chills and rigors, followed by severe headache and nausea/vomiting from 2AM on 1/5/2021 to 0730 1/6/2021. Massive headache still lingering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,None,none,none,,"PCN, Keflex, Compazine","['Chills', 'Headache', 'Nausea', 'Night sweats', 'Vomiting']",2,PFIZER\BIONTECH,IM 922803,ND,57.0,F,"Chills, dizzy, head ache, body aches, hot flashes, nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,"Hydroclorot. zoloft, metformin ER.",Covid positive test 12-4-2020. Lumpectomy 11-11-20,none,,"bactrum, keflex","['Chills', 'Dizziness', 'Headache', 'Hot flush', 'Nausea', 'Pain']",1,MODERNA,IM 922804,,55.0,F,"Patient was very nervous prior to vaccination, and immediately after the injection, she developed vasovagal reaction. It took her at least 30 minutes to recover, but was stable and went home with spouse.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,PVT,"Famotidine 20 mg QD PRN, aspirin/acetaminophen/caffeine QD PRN, Sodium-potassium-magnesium sulfates 17.5-3.13-1.6 gm UD",,,,"Latex, hydrogen peroxide, sulfa","['Immediate post-injection reaction', 'Presyncope']",1,PFIZER\BIONTECH,IM 922806,NJ,64.0,M,Vaccine recipient received 1st vaccine dose on 12/16/2020. The vaccine recipient returned for the 2nd dose of Pfizer-BioNTech vaccine on n 1/5/2021. They reported at the clinic that 5 days after receiving the vaccine on 12/16/2020 developed bilateral tinnitus that was hissing in nature. The hissing abated after a week. Vaccine recipient reported that they will follow up with an ENT provider. The vaccine recipient was not sure if it could be related to the vaccine. Patient has a history of tinnitus but noted it was nothing like prior. Vaccine recipient is a physician. Pfizer-BioNTech COVID- 19 Vaccine EUA.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/21/2020,5.0,WRK,metoprolol,None,None,,"bactrim, ciprofloxacin, and amoxicillin",['Tinnitus'],1,PFIZER\BIONTECH,IM 922807,AZ,31.0,F,"fevers, chills, myalgias",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,none,none,"morbid obesity, hx meth abuse",,none,"['Chills', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 922808,,55.0,F,"Patient was very nervous prior to vaccination, and immediately after the injection, she had a vasovagal reaction. It took her at least 30 minutes to recover, but was able to go home with spouse.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,PVT,"famotidine 20 mg QD PRN, aspirin/acetaminophen/caffeine QD PRN, Sodium, potassium, magnesium sulfates 17.5-3.13-1.6gm take as directed",,,,"Latex, hydrogen peroxide, sulfa","['Immediate post-injection reaction', 'Presyncope']",1,PFIZER\BIONTECH,IM 922809,MI,30.0,M,1/4 7pm Vaccication 1/4 8pm started feeling itchy mouth and face 1/4 8:30pm took benadryl 50mg 1/4 11:30 symptoms mostly resolved 1/5 830am sysmtoms returned 1/5 845am benadryl 50mg & went to ER 1/5 ER recommended I take Zyrtek & Pepcid instead of bendryl as of 1/6 at 11:30am still have a very mild itchy face and tonge,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,LOSARTAN 25 MG BUPROPION 100 MG SR GABAPENTIN 900 MG,,Hypertension ADHD Restless Leg Syndrome,,,"['Oral pruritus', 'Pruritus', 'Tongue pruritus']",1,PFIZER\BIONTECH, 922810,TN,50.0,F,"The evening of the vaccine around the injection site exp redness, swelling lasted 3 days went away. After 10 days the injection site it appeared 3 inches was deep, red and exp itching. I took Benadryl the redness, swelling went away.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/21/2020,1.0,PVT,"Topamax, Promethozol, Benlofaxon ,Multi Vit, Vit D,",No,"Arthritis, Hypertension","Tb skin, Flu","Mil (Gi upset), Penicillin","['COVID-19', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 922811,TX,27.0,F,Fever around 4PM on 12/25 with chills and feelings of being feverish. Was as high as 103.1. Body aches starting 12/25 and lasting until 12/30 that were severe for 24 hours. Nausea and headache starting 12/26 and lasting until at least 12/31.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,WRK,"Symbicort, Celexa, Nexplanon",Treated for Strep throat on 12/22/2020,Asthma,,"Ibuprofen, Keflex Toradol, Avocado, Latex","['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 922812,CA,43.0,F,"A Ring of small scabs about 1/4"" from injection site, then itching. On 1/4 in evening, a small rash which was examined by physician on 1/6. Rash now approximately 2""x3"" in diameter and radiating down arm and toward armpit. MD will be treat as cellulitis.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,UNK,"Montelukast, Fexofenadine, Dulera inhaler, Budesonide nasal spray, Duloxetine, Junel Fe",None,"Intermittent asthma, allergic rhinitis",,Isosulfan Blue,"['Cellulitis', 'Injection site pruritus', 'Injection site scab', 'Rash']",1,MODERNA,IM 922813,OH,37.0,M,"Fever, chills, night sweats, fatigue, loss of appetite",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,None,Covid 19 infection one month prior,None,,None,"['Chills', 'Decreased appetite', 'Fatigue', 'Night sweats', 'Pyrexia']",UNK,MODERNA, 922814,ME,30.0,F,a week late woke up with large red circle around site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/03/2021,8.0,WRK,multi-vitamin,none,asthma,,none,['Injection site erythema'],UNK,MODERNA, 922815,ND,43.0,F,"7pm.. chills, mild body aches, 8pm.. worsening chills, headache and moderate body aches 9pm-2am.... chills, headaches, moderate body aches 7am.. mild bodyaches, headache 11:15.... sx gone MILD body aches the next morning.... of note hx of COVID dx 9/2020",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"multivitamin, vitamin D, zinc",,,,nkda,"['Chills', 'Headache', 'Pain']",1,MODERNA,IM 922816,NJ,41.0,F,"Immediately upon injection, tingling all over lasted for about less than 1 minute. Within 20 minutes, tingling & facial muscle tightness around mouth. Twitching & facial mouth muscle tightness for about 4 days, diminishing each day. Vaccine was given Wed evening...finally Sun was little to none symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PHM,"Atorvastatin, Metoprolol Succinate, Premarin, Women's One-day day MVI, Vitamin D",,"Migraine Headaches, BRCA2+, prophylactic double mastectomy & recontruction",,"Theophylline, Adhesive sensitivity","['Immediate post-injection reaction', 'Muscle tightness', 'Muscle twitching', 'Paraesthesia']",UNK,PFIZER\BIONTECH,IM 922817,CT,31.0,F,1 episode of vomitus 3 days after shot,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/27/2020,3.0,PVT,"Not at the time of vaccination, but daily: Nortrel & MVI/min","NA, Good Health",,,Contact dermatitis to mangoes and bounce dryer sheets,['Vomiting'],1,MODERNA,SYR 922818,FL,48.0,M,"Arm soreness, headache for a day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,WRK,"Metoprolol ER, Amlodipine-olemesartan, Lexapro",None,Hypertension,,Wellbutrin,"['Headache', 'Pain in extremity']",UNK,PFIZER\BIONTECH,IM 922819,AZ,31.0,F,"At 10 pm I started having severe body aches, fatigue, alternately feeling hot and cold, moderate headache, weakness, sweats",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2020,01/05/2020,0.0,OTH,"Klor Con, prenatals, 325mg ASA, 5000IU Vit D3","COVID, symptomatic until ~12/10/2020",PCOS,,None,"['Asthenia', 'Fatigue', 'Feeling of body temperature change', 'Headache', 'Hyperhidrosis', 'Pain']",1,PFIZER\BIONTECH,IM 922820,NC,33.0,F,"Last night (4 hours after injection) axillary lymphnodes on injection side were enlarged and severely painful. Upon waking this morning axillary lymphnode pain persists, left inguinal lymphnode is painful, moderate to severe fatigue and temperature of 99.9 degrees when checked at work with mild dizziness. Heart palpitations while trying to sleep last night, resting heart rate was 86 BPM higher at times.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,1 unisom sleep tab per night,none,none,,none,"['Body temperature increased', 'Dizziness', 'Fatigue', 'Heart rate increased', 'Lymph node pain', 'Lymphadenopathy', 'Palpitations']",1,PFIZER\BIONTECH,SYR 922821,TX,72.0,M,"When I received the vaccine I did not feel anything, 12hrs after the vaccine my arm suddenly became very sore. I developed severe chills and low grade fever, muscle and joint pain, my hands and feet were cold, headache, and uncontrolled yawning, I suppose my body's attempt to cool the brain. I took 600 mg of ibuprofen and the symptoms mostly abated, but returned about 4hrs later. I am treating myself with ibuprofen and acetaminophen. I have not seen my PCP, I feel the symptoms will resolve with time, if not I will follow-up. I cannot find anything in the literature but do people that have had covid get a stronger reaction from the vaccine?",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"ezetimibe, irbesartan, Montelukast, pantoprazol, vitamin B12","none, although I tested positive for covid-19 the end of September through first of October. Was in the hospital for 3 days mostly due to dehydration. I had more GI issues with covid than respiratory.","hypertension well controlled, GERD",,No know drug or food allergies,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Pain in extremity', 'Peripheral coldness', 'Pyrexia', 'Yawning']",1,MODERNA,IM 922822,FL,36.0,M,Increased body temperature (mostly torso) Headache/migraine Slight cloudiness/fuzziness in my head.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Animal Pak multi-vitamin Animal Flex joint supplement,None,Joint pain in shoulders and knees.,,None,"['Body temperature increased', 'Feeling abnormal', 'Headache', 'Migraine']",UNK,MODERNA,IM 922823,MA,95.0,F,"Delirium, confusion, anxiety, and depression Nausea, no appetite headache, body aches pale, flushed cheeks Low blood pressure",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,SEN,Florosemide (Lasix) 3 time week Lipitor Imipramine Metropolol 25 mg 1 x day Gabapentin 12.5 3 x week Iron 325 mg 2 x day Spirolactin,,"Stage 3 Kidney disease Conjestive Heart Failure Panic Attacks, anxiety, depression Some elder dementia High Cholesterol High BP",,Penicillin,"['Confusional state', 'Decreased appetite', 'Delirium', 'Depression', 'Flushing', 'Headache', 'Hypotension', 'Nausea', 'Pain', 'Pallor']",UNK,PFIZER\BIONTECH, 922824,WV,57.0,M,"Four days after immunization onset of arthropathy in left fifth toe (red, pain, edema) progressed on seventh day with enthesitis /Swelling left medial malleolus. Day 12 progressed to tender, swelling Achilles? tendon left side, day 14 stiff great toe and foot edema. Difficulty ambulating on left foot. Prednisone prescribed but not started to this point. This flare similar to IBD arthropathy in past but have been in remission until vaccinated.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/27/2020,4.0,PVT,"Turmeric 1 g BID. Vitamin D3 5000 IU QD, Vitamin B 12 1000 �g QD, RESVERATROL 500MG QD, probiotic QD Pepcid 20 mg b.i.d. , imuran 50mg QD, Benicar 10mg QD",None,"Ulcerative Colitis, MGUS, HTN, GERD",,NKDA,"['Arthropathy', 'Enthesopathy', 'Erythema', 'Gait disturbance', 'Joint swelling', 'Musculoskeletal stiffness', 'Oedema peripheral', 'Pain in extremity', 'Tendon discomfort']",1,PFIZER\BIONTECH,IM 922825,FL,23.0,M,"Pt received COVID vaccine in left arm and sent to observation room for 15 mins. After 5 minutes patient stated he felt tingling in both hands with noted swelling in his palms. Pt was flush and stated he felt warm. Dr. evaluated patient and order Benadryl 25mg PO. Vital signs 124/70, P 72, R 20, SPO2 98%. After Benadryl administration Pt escorted to the emergency room by staff for further follow up. Pt was given 25mg of Benadryl PO c/o of tingling and swelling in hands with flushing of the face without signs of SOB.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,MIL,None listed,None listed,None listed,,Unknown,"['Feeling hot', 'Flushing', 'Paraesthesia', 'Peripheral swelling']",1,PFIZER\BIONTECH,IM 922826,TX,38.0,F,Extreme fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,Sertraline and Valtrex,None,Anxiety,,Sulfa,['Fatigue'],1,PFIZER\BIONTECH,SYR 922827,PR,33.0,F,"At the same day I felt my neck hurting all the way to my elbow. As the days progressed the pain got worse and I started feeling a bump on my neck. My whole left side from my neck to my elbow I would feel tremendous pain. Days passed and nothing would get better so I spoke with my supervisor and she recommended me to go to the ER where they did some labs (blood work). About 2 weeks later the pain in my left side subsided but the swelling on my neck and the ""bump"" never went away, although not painful. I received the second dose on 01/04/2021 and the same pain returned from my neck down to my elbow and the neck is swollen again and in pain. I decided not to go to the ER for the second dose and did not obtain medical help so far.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/15/2020,12/16/2020,1.0,PVT,Albuterol as needed,No,asthma under control,,Unknown,"['Arthralgia', 'Neck pain', 'Swelling']",1,PFIZER\BIONTECH,IM 922828,NV,39.0,F,Red itchy and hot to the touch. it was primarily 6-7 inches around the arm where the vaccine was received it was 3-4 inches wide and 6-7 inches long.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/04/2021,8.0,PUB,denies,denies,denies,,Dulaxatine daily,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 922829,MN,35.0,F,"Hives, burning sensation in her arms, anxiety. Noted she felt like she was hyperventilating.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/20/2020,0.0,WRK,,Conjunctivitis diagnosed via e-visit on 12/6/20.,,,Patient reported allergy to purple saniwipes,"['Anxiety', 'Burning sensation', 'Feeling abnormal', 'Hyperventilation', 'Urticaria']",1,PFIZER\BIONTECH,IM 922830,CA,45.0,F,Fatigue Extreme pain swelling chills didn't feel well body aches massive headache,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,UNK,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Swelling']",1,MODERNA,SYR 922831,IN,37.0,F,"Chills, myalgia, headache lasting approximately 18 hours from onset. Some fatigue but not main symptom.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Myalgia']",1,MODERNA,IM 922832,MD,35.0,F,"within 5 minutes of receiving vaccine became hot and flushed, diaphoretic, nauseated, lightheaded, and felt faint",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,,anxiety,,,"sulfa, Kiwi","['Dizziness', 'Feeling hot', 'Flushing', 'Hyperhidrosis', 'Nausea']",1,PFIZER\BIONTECH,IM 922833,MO,34.0,F,"Starting Sunday 1/2, a small, painful and itchy red area appeared on the left deltoid. By the next evening, it was larger, firmer, and more red. Circled area, and it has grown in size. Contacted employee health for work but have not heard back. Today, Wednesday 1/6, it is less firm and less red, but still larger, reaching my shoulder and about an inch below yesterday's mark.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/03/2021,6.0,WRK,"Multivitamin OTC Gianvi Birth Control Prescription 2 g Fish Oil OTC GNC Hair, Skin, & Nails OTC",None,None,,Sulfa,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 922834,MO,59.0,F,"This is a 59-year-old female who's possible reaction to the Covid vaccine was as follows: She had gotten the vaccine at approximately 8:30 AM and had stayed at the vaccination area for about 15 minutes and felt okay. She got up to walk outside and started feeling dizzy. Her hands felt tingly. She also felt a little short of breath. She came back in and sat down and the symptoms did not seem to really improve. She states they have been about the same over the last 20 minutes or so. She was then escorted to the ED of the facility for evaluation & treatment if needed. Per the ED doctor's notes: "" The patient did feel much better after just being observed here and after getting Benadryl."" She was released home. Employee health followed up with her at 4:30 PM the same day & at 9:45 am 1/6/21--she reported that she was doing well at both follow ups, a little tired but had not had any repeat of previous symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Albuterol, amlodipine, amoxicillin, augmentin, benzonatate, cholecalciferol, citalopram, Denta 5000 plus, estradiol 0.01%mg/gm cream, fluconazole, gabapentin, ipratropium NS, losartan-HCTZ, metronidazole, naproxen, nitrofurantoin, nortripty",hematuria,"DJD of knee, osteoarthritis of knee, unilateral; Acute laryngopharyngitis, sinusitis",Shingrix,betadine,"['Dizziness', 'Dyspnoea', 'Fatigue', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 922836,AZ,52.0,F,"Pain and swelling on injection site, Cold chills, headache and fatigued",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling']",1,PFIZER\BIONTECH,SYR 922837,KY,32.0,F,"Lightheaded, dizzy, nausea, flushed, dry mouth began about 10 min after vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,,,,,NKA,"['Dizziness', 'Dry mouth', 'Flushing', 'Nausea']",1,PFIZER\BIONTECH,IM 922838,TX,41.0,U,"About 5 minutes after vaccine was given, tingling sensation occurred on left arm down to left hand (Thumb, index, middle finger.) Grip is good both hands ON 12/31/2020 Patient experienced ""Nickle sized welts on her elbow, wrist and stomach. She also experienced more tingling in her left arm. There was 2 welts on her Left wrist and 1 welt on her left elbow. The welt on her stomach was on her right side. She took some Zyrtec and applied warm packs. The welts resembled an ""ant bite"", ""raised but no pus"" in them. As of today 1/5/2021, they are resolved and patient feels better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PUB,none,none,none,,Cipro (N/V),"['Paraesthesia', 'Urticaria']",2,MODERNA,IM 922839,NV,24.0,M,"Bell's Palsy of 7th Nerve, treatment Prednisone 60 mg QD x 7 days, outcome TBD",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,01/04/2021,16.0,PVT,"Vitamin D, Ketotifen eye gtts",,,,NKDA,['Facial paralysis'],1,PFIZER\BIONTECH,IM 922840,OK,38.0,F,Currently 9 weeks 2 days pregnant. Began having spotting the morning after receiving the vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,Prenatal vitamin and synthyroid,None,None,,None,"['Pregnancy', 'Vaginal haemorrhage']",1,MODERNA,IM 922841,NC,48.0,M,"Itching on scalp and hands, numbness mouth",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,MIL,none,GERD,GERD,,none,['Pruritus'],1,PFIZER\BIONTECH,IM 922842,PA,31.0,F,Bellow injection side Redness Itchiness Swollen Warm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,Birth control pills,,,,Penicillin Sulfa Antibiotics,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 922843,NJ,45.0,F,"[1] Lightheadedness: started 1 minute after vaccine, lasted 1-2 minutes. Relieved with meditative breathing; believed it to be anxiety related until seeing CDC produced list of symptoms from vaccine. [2] Mild soreness, mild redness at injection site: started 4 hours after vaccine, lasted 24-36 hours. [3] Felt feverish and flushed, arthralgia: started approximately 18 hours after vaccine (12/31/2020). ""Fever"" initially managed with Tylenol 650 mg. Later that evening took naproxen 440 mg to address arthralgia, which lasted about 2 days. No medication taken on 1/1/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None,Nonw,"Solar urticaria (as above), intermittent allergic asthma",,"Canteloupe, Honeydew. Solar urticaria - triggered by UVA and purple spectrum of visible light","['Anxiety', 'Arthralgia', 'Dizziness', 'Flushing', 'Injection site erythema', 'Injection site pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 922844,TX,28.0,F,"Fever, chills, cough. Officially tested positive on 01-06-2021. Two days after receiving vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,UNK,None,None,None,,None,"['COVID-19', 'Chills', 'Cough', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 922845,AR,57.0,F,"Described started ""itching 30 minutes after shot administered. That night she noticed a ""rash all over her body, no problems breathing"". The next day she experienced ""swollen lips and tingling and itching from head to toe"". She reports she is taking Pepcid and Benadryl. She also reports "" no problems with breathing"".",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,Gabapentin Tizanidine modafinil Wellbutrin hydrocodone,None known.,Spine surgery in 2007,,Rocephin,"['Lip swelling', 'Paraesthesia', 'Pruritus', 'Rash']",UNK,PFIZER\BIONTECH,IM 922846,MA,25.0,F,Received Vaccination Tuesday 12/29 and symptoms began Tuesday 1/5. 1/5 began experiencing pain at the injection site and later in the night noticed redness and a hardened bump at the site. While trying to sleep I noticed pain had traveled toward the clavicle area where a swollen lymph node was noticed not sure if related.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,Fludrocortisone Mestinon Vitamin D Vienva Birth Control Multivitamin,None,Dysautonomia/Postural Orthostatic Tachycardia Syndrome,,Allergy to Amoxicillin,"['Injection site erythema', 'Injection site nodule', 'Injection site pain', 'Lymphadenopathy']",1,MODERNA,SYR 922847,FL,61.0,F,"Injection Site redness, swelling and heat. Shortness of breath",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/06/2021,10.0,PVT,"Prenatal Vitamins, Lisinopril 10 MG 1 /day, Omeprazole 40mg 2/day, Mag Oxide 400Mg 3/day, Oscal 1/day, Klor-con M20 ER 20 MEQ 2/day, Aspiin 81 2/day, Montelukast 10mg 1/day, Hydochloroot 25mg 1/day, Trazodone 100 mg 1/day ,Ventolin hfa 90mc","COPD, Pnemonia, High Blood pressure, Complicated Migrains,Chronic Microvascular ischemic disease, Diabetes Mellitus, Sleep Apnea, Hypokalemia, Magnesium deficiency","Diabetes Mellitus, Sleep Apnea, Hypokalemia, Magnesium deficiency, High Blood pressure, Complicated Migrains,Chronic Microvascular ischemic disease,",,Sulfa Drugs Losartan,"['Dyspnoea', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA,IM 922848,NC,53.0,F,"intense rash both arms, neck and upper torso. Treatment: steroid injection by provider, benadryl, Pepcid Outcome: next morning symptoms gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Xanax, Benadryl, Estradiol patch, Lozol, Miralax, Synthroid , zocor, BC power,",Headache,"IBS, Hypertension, anxiety, lipid disease,",,none,['Rash'],1,PFIZER\BIONTECH,IM 922849,MA,59.0,M,"""I've got 1st vaccination shot at 11 am 12/21/2020. Got moderate (3 to 5 on 10-steps scale) pain in left upper arm/shoulder around 9 pm, limited mobility. Took 2 extra-strength Tylenols. Between 2 and 3 am woke up because of severe headache (7 to 8), couldn't normally sleep because of that. Temperature 99.6 F. Another 2 Tylenols about 4 am. Not effective. Drinking a lot of water. Decided to stay home. Contacted my supervisors by text and e-mail, left a voice message for EH. 8 am - another 2 Tylenols. Tried to sleep - slept till 1 pm. Headache improved (3-5), 99.3 F. Water and tea, minimal activity. Received instructions from EH - to stay at home if any symptoms will take place, to get COVID test upon returning to the hospital. Condition was improving during the day. Low pain and discomfort in the evening (2-3). Sleeping normally during the night. No symptoms in the morning. No reason to delay returning to work. Took COVID test at 9 am. Negative. No symptoms since then""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,no,no,no,,no,"['Arthralgia', 'Body temperature increased', 'Discomfort', 'Headache', 'Impaired work ability', 'Mobility decreased', 'Pain in extremity', 'SARS-CoV-2 test negative', 'Sleep disorder']",1,PFIZER\BIONTECH,SYR 922850,ID,46.0,F,"c/o l122/67, c/o lighted, itchy eyes, warm. She took Benadryl 50 mg at 0700 - 2 hours prior to event. 0900 - bp 126/70, hr 107, rr 20, sats 100 0905 - bp 122/67, hr 90, rr, 18, sats 100 0910 - bp 113/66, hr 81, rr 20, sats 100 - lightedness no longer present, she c/o of being cold, 0915 - dry throat that water helped. denied throat itching, states breathing wnl. 0915 - bp 120/80, hr 88, rr 20, sats 100 Pt reports that she feels better. She is off work today, but she will stay in the rt office with staff for 30 minutes before going home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Zyrtec,none,allergies,,uncooked shrimp; some nuts,"['Dizziness', 'Dry throat', 'Eye pruritus', 'Feeling cold']",2,PFIZER\BIONTECH,IM 922853,VT,40.0,F,"After vaccine administration, c/o of dizziness, ""woozy"", after 30 minutes c/o bilateral leg tingling/weakness, difficulty ambulating.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,WRK,,,,,,"['Dizziness', 'Gait disturbance', 'Muscular weakness', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 922854,GA,54.0,F,"One week after the vaccine I was find until....I got out of my car after driving and started staggering and could not function. Severe dizziness, heavy headedness , nausea and vomiting and a horrible headache. My husband had to physically muscle me back to my car. He wanted to take me to the ER and I would not let him because of the waiting room is full of COVID positive patients. I threw up along the way home and multiple times to the point I had drive heaves. I am a Registered Nurse and felt the symptoms I were experiencing were Vertigo. I had one bout with Vertigo in 2015 and it was extreme. I had Meclizine on hand and and took one tablet and slept. The severity of this was so bad I could not walk unassisted or sit up without falling over. After 6 hours of sleeping I got up, dizziness continued, and vision a little off. I still do not feel 100% I have had a headache since. It never dawned on me this could be from the vaccine I had taken a week before.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/29/2020,8.0,PUB,None,None,None,,None,"['Dizziness', 'Feeling abnormal', 'Gait disturbance', 'Head discomfort', 'Headache', 'Loss of personal independence in daily activities', 'Nausea', 'Retching', 'Vertigo', 'Visual impairment', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 922855,,32.0,F,"Received Pfizer Lot EL1284 1-6-2021 in right arm 1-6-2021. Went home and started to have light headedness, sweaty palm, hot flashes. She has been drinking water and ate before and after receiving the shot. No reactions to other vaccinations. Has history of anxiety and depression.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Dizziness', 'Hot flush', 'Hyperhidrosis']",1,PFIZER\BIONTECH,IM 922856,CA,59.0,F,generalized rash. resolved in 2 days with benadryl.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/23/2020,2.0,PVT,,,,,,['Rash'],1,PFIZER\BIONTECH,IM 922857,NY,45.0,F,"Diarrhea, Headache, Fatigue, took tylenol with relief",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/03/2021,6.0,PVT,,,,,,"['Diarrhoea', 'Fatigue', 'Headache']",1,MODERNA,IM 922858,ME,50.0,F,"Presented in ED with a reddened and swollen area of her left deltoid region.. The patient states that she received the Madrona vaccine on 21 December in the left deltoid. She states that she had no problem with the vaccine initially. She states that she even hiked this last weekend and felt fine. She states that she developed a reddened area of the skin 3 days ago that has been increasing in size. It is now tender and somewhat warm to the touch. She states that she also felt some itchiness of her upper chest. She is not sure if she has any true hives in this area. She denies facial, tongue, or lip swelling. She denies difficulty breathing. She denies chest pain. She denies abdominal pain, nausea, vomiting. ASSESMENT and PLAN � Erythematous, hive-like region of the left deltoid that began 12 days after the Moderna vaccine. This is likely a localized delayed type IV hypersensitivity reaction. Bedside ultrasound performed by myself. I do not note any pocket of fluid to indicate an abscess. However, there is a small possibility that this could be cellulitis. A cellulitis would be much more concerning. From an allergic perspective, she has no evidence of anaphylaxis based on the timeframe and her current symptoms. As a result, she will continue on Benadryl for now at 50 mg every 6 hours and will be placed on doxycycline 100 mg twice a day for 10 days. May use prednisone taper but she should wait for 48 hours. If she has improvement with doxycycline and Benadryl, she should continue with this. The Benadryl is truly as needed and if it is improving, she does not need to continue on it. She will.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,01/03/2021,13.0,OTH,Albuterol inhaler,none known,"? Anxiety � ? ASCUS with positive high risk HPV cervical ? Depression � ? Dysfunctional uterine bleeding regulated with COC ? Female pelvic inflammatory disease � ? Fibrocystic disease of breast � ? Microscopic hematuria, non-persistent ? OSA (obstructive sleep apnea)",,none known,"['Erythema', 'Hypersensitivity', 'Injection site erythema', 'Injection site swelling', 'Pruritus', 'Rash erythematous', 'Skin warm', 'Tenderness', 'Urticaria']",1,MODERNA,IM 922859,TX,29.0,M,"12/17 vaccination 12/20 Wen to use restroom. Reddish hue in urine. Went to urgent care. UTI was negative. Positive for blood in urine. Next day, urine back to normal. Arm soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/20/2020,3.0,PVT,Crestor/Daily,,HX kidney stones,,"sulfa, erythromycin","['Blood urine present', 'Chromaturia', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 922860,OH,46.0,F,"Moderna COVID-19 Vaccine EUA Local allergic reaction at injection site: Redness, swelling, hot, itching Began 2 days after injection, got better, then worse again 1 week later.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,"Generic Claritin, vitamins, Miralax",,Sleep apnea,Headaches and arm redness after flu shot in the past,"Ceftin, Zomig","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Local reaction']",UNK,MODERNA, 922861,MO,39.0,F,"Fever 102, n/v/d, headache continuous, fatigue, decrease appetite, lethargic, body aches, and liver enzymes over 300. still sick after 6 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,none,Covid-19 November 1 onset of symptoms,none,,none,"['Decreased appetite', 'Diarrhoea', 'Fatigue', 'Headache', 'Hepatic enzyme', 'Lethargy', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 922862,,38.0,F,"Noticed yesterday itching on right arm, woke up today and arm has a red circle around injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/27/2020,01/05/2021,9.0,PUB,NONE,NONE,NONE,,NONE,"['Injection site erythema', 'Pruritus']",1,MODERNA,SYR 922863,NJ,52.0,F,Fever- tmax 101.2. Duration approx. 10-12 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,SEN,Unknown,Unknown,Diabetes mellitus,,Unknown,['Pyrexia'],1,PFIZER\BIONTECH,IM 922864,TX,,F,after I received the shot a few days later in rthe evening I had a little congestion and a slight cough. I had pain in my arm at the injection site for 3 days. I called my Doctor and scheduled an appointment but I have not seen him yet.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,"metformin, gliparide, Amlodipine, cholesterol medication,",no,diabetes high cholesterol cancer remission 7/2020,,no,"['Cough', 'Injection site pain', 'Respiratory tract congestion']",1,MODERNA,SYR 922865,NY,44.0,F,"Pt reported minor itching/hives in her arms and back after 15 minutes of receiving the vaccine. Pt was given diphenhydramine IM 25mg Denies SOB, chills, or trouble breathing. Will continue to monitor.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,WRK,Keflex 350mg TID for 7days Elderberry,Cyst underarm - went to PCP abx given,,,Fish/seafood - angioedema Nuts - angioedema Seasonal allergies - rhinitis,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 922866,TX,48.0,F,"Body Aches, Tiredness, Severe Headaches TX-Husband took her to the Urgent Care-5 Jan 2021 two injections given to her-Toradol, Zofran, Iv therapy also, prescription for Urrelvy-for migraines-she didn't fill it yet",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,MIL,Imgality-miagraines every month injection as needed Motrin 800mg-headaches,"Chronic-migraine headaches, Fibromyalgia",as above-migraines & fibromyalgia,,medication-Topamax,"['Fatigue', 'Headache', 'Pain', 'Photophobia']",1,PFIZER\BIONTECH,IM 922868,TX,58.0,F,"Small knot and sore arm first day post vaccine. 8 days post vaccine larger knot; red, raised area measuring approximately 2""x1.5"". Red area itches. Concerned whether this reaction will affect second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,"Lisinopril 10mg daily; Wellbutrin 150mg BID; Sertraline 100mg qHS; Claritine OTC; Metamucil OTC; Flonase PRN, OTC allergy eye drops",Depression,"HTN, seasonal allergies",,"No known drug allergies, sensitive to adhesives","['Erythema', 'Nodule', 'Pain in extremity', 'Pruritus', 'Swelling']",1,MODERNA,IM 922869,MA,25.0,F,"Received vaccine Tuesday 12/29 and adverse event occurred Tuesday 1/5. Adverse event being: began experiencing pain at the injection site, later noticing redness and a hardened bump at the injection site. While sleeping later in the night pain had travelled toward the clavicle area where a swollen lymph node was noticed not sure if related to the adverse event. Today, 1/6 pain, redness, and hardened bump are still there.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,Fludrocortisone Mestinon Vienva Birth Control Vitamin D Multivitamin,None,Dysautonomia- Postural Orthostatic Tachycardia Syndrome,,Amoxicillin,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,SYR 922870,GA,36.0,F,"Her arm has developed a hot, swollen, red area where the injection was given. It started as a knot 3 days ago and has become worse over the last few days. She has called her PCP so that they can follow up on this. She is planning on getting an appointment with her PCP",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/02/2021,4.0,PUB,None,None,None,,None,"['Injection site erythema', 'Injection site nodule', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 922871,MA,56.0,F,"""Received vaccine around 9:30am without any initial reaction. Around 9:30pm developed rigors felt cold no fever went to bed and rigors subsided after 20 minutes. Body did ache overnight and headache developed. Took Tylenol with some relief. In am aches and rigors remained absent but still had dull headache. Took headache medicine and otherwise felt fine. I have a history of feeling like this in the past after receiving my flu shot.""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Zyrtec Ecotrin Motrin Metamucil and Omeprazole,Cough,,,Penicillin,"['Chills', 'Feeling cold', 'Headache', 'Pain']",1,PFIZER\BIONTECH,IM 922872,IL,53.0,F,Experienced site redness and rash in L deltoid area within 24 hours of injection which resolved 1/5/2020 1/3/2020 Experienced pain in L axillae radiating down the arm. Arm feels numb. 1/5/2020 Temp 98.5 normal temp 97.0 . Axillary pain and tenderness remain present during conversation 1/6/2020.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/03/2021,3.0,PUB,Losartan,,Hypertension,,none,"['Axillary pain', 'Hypoaesthesia', 'Injection site erythema', 'Injection site rash', 'Pain', 'Pain in extremity']",1,MODERNA,IM 922874,,36.0,F,"40 seconds after shot: tingling in left arm and left hand with then wooziness. Tingling itching sensation and mind pain in left arm and hand continued for a few hours then spread into left leg which continued into the next day. Moderate left shoulder tenderness 6 hours after shot lasting 2 days. 6 days after shot severe lethargy, body aches and brain fog which is current on 01/06/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Dizziness', 'Feeling abnormal', 'Injection site pain', 'Lethargy', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Pruritus']",1,PFIZER\BIONTECH,IM 922875,WV,65.0,F,"After receiving vaccine, c/o being lightheaded, dizzy, headache, left arm pain with fingers tingling, sore throat and chest tightness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,WRK,,,,,,"['Chest discomfort', 'Dizziness', 'Headache', 'Oropharyngeal pain', 'Pain in extremity', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 922876,PA,22.0,F,"The patient was observed for the required time and then released from the clinic. While driving home, she felt very tachycardic. She assessed her pulse as being 165 and returned to the vaccination clinic. By the time she returned, she felt dizzy and nauseated. Medical command was contacted who advised for paramedics on site to administer 50 mg of Benadryl IV as well as 4 mg of Zofran and an IV fluid bolus. Those treatments were executed, the tachycardia resolved and the patient felt better. She was transported to the Hospital for further evaluation and treatment as a precaution.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,n/a.,None.,None.,,None.,"['Dizziness', 'Nausea', 'Tachycardia']",1,PFIZER\BIONTECH,SYR 922878,NJ,60.0,F,"Dizziness, tingling, possible anxiety attack",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Epi-pen prn,,,,Yes - history of anaphylaxis or severe reaction 15 years earlier to an allergy injection for cats,"['Dizziness', 'Paraesthesia']",1,PFIZER\BIONTECH, 922879,TX,39.0,M,"Patient stated he felt 'little dizzy"", appeared clammy. No other reaction noted, denied any SOB.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PUB,Unknown,,,,,"['Cold sweat', 'Dizziness']",1,MODERNA,IM 922880,NJ,58.0,F,"Today, January 6th, one week after I had first vaccine, I noticed that the area of the injection is red, swollen and a little itchy. The redness is probably around 2 inches in diameter. Immediately after the vaccine, my arm was sore for about 2 days. I'm just noticing the swelling and redness today- perhaps because I can feel it.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/06/2021,8.0,OTH,"Omega 3, calcium, multi vitamin, vitamin D",,,,,"['Immediate post-injection reaction', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Pain in extremity']",1,MODERNA, 922881,PR,60.0,F,"After 7 days; sweeling, red, itchy, the red area expanded. Treatment; augmentin 800mg bid, benadryl 50mg hs, hydrocortisone cream bid. Waiting for results.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PUB,Ibersartan 150mg/d Lipitor 10mg/d,none,"HBP, mild high colesterol",chingles vacinne (celulite on the arm),None,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA,IM 922882,NY,60.0,F,"About 8 hours (1800) after receiving vaccine, developed nausea/vomiting, fever/chills, headache. Recorded temp ?a little over? 101 F.; vomiting lasted until 1/1/2021 0300; headache lasted through 1/3/2021. On 1/2/2021 took 2 extra strength Tylenol, repeat 2 pills on 1/3/2021 with improved headache ; Took total of 4 TUMS, 1 each after vomiting episode felt relief.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Chills', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 922883,PA,41.0,F,Shingles-diagnosed at Urgent Care,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PVT,none,none,none,,none,['Herpes zoster'],UNK,PFIZER\BIONTECH, 922884,PA,30.0,F,"Insomnia. Muscle aches, headache, fever, chills, hives, itching",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,No,None,None,,"Apples, cherries, pitted fruits, latex, every tree , pollen, seasonal","['Chills', 'Headache', 'Insomnia', 'Myalgia', 'Pruritus', 'Pyrexia', 'Urticaria']",UNK,MODERNA, 922885,CA,33.0,F,"""Moderna COVID-19 Vaccine EUA"" The next day sore arm (injection site) x2days, fatigue, body aches, on and off headaches, nausea, mild sore throat. All symptoms x7 days since 12/31/2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,WRK,none,none,none,,"Amoxicillin, Flagyl","['Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Oropharyngeal pain', 'Pain']",1,MODERNA,IM 922886,OH,58.0,F,"Shaking Chills, Headache, Nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,None,None,None,,Sulfa,"['Chills', 'Headache', 'Nausea', 'Tremor']",1,MODERNA,IM 922887,OK,76.0,M,Very mild soreness at injection site. No other adverse events.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PUB,,,,,,['Injection site pain'],1,MODERNA,SYR 922888,MN,23.0,F,"chills, extreme body aches, pain at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,topical betamethasone dipropionate,none,none,"flu vaccine 09/2019, body aches",none,"['Chills', 'Injection site pain', 'Pain']",1,PFIZER\BIONTECH,IM 922889,GA,33.0,M,"""Got vaccine 8 am 12/29, started symptoms on 5 pm yesterday high grade fever and chills""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Chills', 'Pyrexia']",1,MODERNA,IM 922890,LA,56.0,F,"On the first, second, and fifth night I experienced chills and slight joint pain. The episodes last about 90 mins. each time. Advil seemed to relieve the symptoms I experienced significant pain surrounding the injection site for at least 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,Losartan 50mg,,High blood pressure - controlled,"Shingrix, 3/6/20 - age 55 years; uncontrollable chills, fatigue (both lasting 2 days)",Augmentin - hives; mold,"['Arthralgia', 'Chills', 'Injection site pain']",1,MODERNA,IM 922891,OH,51.0,F,"Day 7-Red, inflamed, hot to touch, itchy and bumpy around injection site on arm. Redness extended from shoulder to elbow. Arm very achy. Arm was just a little sore after the shot for about two days then there was not discomfort at all until day 7.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,OTH,montelumast 10mg 1 per day metoprolol 25 mg 1 per day minvey 1mg 1 per day,,WPW,,,"['Discomfort', 'Injection site erythema', 'Injection site inflammation', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity']",UNK,MODERNA, 922892,IN,37.0,F,"Fever 100, chills, body aches, joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Setraline,None,None,,Penicillin,"['Arthralgia', 'Chills', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 922894,PA,63.0,F,"redness, injection site is raised, itchy and warm to the touch. Took Benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,WRK,"Progesterone, Omeprazole, vitamin supplements, Claritin D",,epidural injections for back problems,,sulfa,"['Erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 922895,PA,54.0,F,"Itching, redness around injection site approximately 5x7cm. Rash to upper part of upper arm, as of this report 5 hives to upper arm, itching to left side of face and neck. All these I have experienced with previous vaccines that are not latex free.....especially if if syringes are loaded via drawing fluid from a vial. As of this writing symptoms are not worsening but not totally resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,"Benadryl, Tylenol",None,None,"2020 Flu vaccine.....age 54, Itching to injection site, redness and hives to entire upper arm, rash to upper arm, itching to","Latex, Cillins, Myacins, Lomotil, Sulfa","['Injection site erythema', 'Injection site pruritus', 'Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 922896,SC,41.0,F,"Injection site pain 1.5 days, extreme fatigue days 2&3",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PVT,"Wellbutrin SR20 mg, Adderall XR 20mg",none,none,,none,"['Fatigue', 'Injection site pain']",1,PFIZER\BIONTECH,IM 922897,,37.0,F,"significant swelling about 2"" below injection site. it's red, hard, and itching. arm is sore all the way around",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,UNK,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Pain in extremity']",1,MODERNA,IM 922898,TX,47.0,F,"Patient reported ""tingling"" in both arms and ""metallic taste"" in the mouth.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PUB,None,None,None,,None,"['Dysgeusia', 'Paraesthesia']",1,MODERNA,IM 922899,CA,40.0,F,"Arm was sore and swollen for 3 days post injection. Minor swelling and firmness from injection site and slightly below continued. On 1/5/2021 (a week after the injection), redness formed and 3 big spots measuring about 1-1/2 inches appeared. Spots are firm to touch. No pain, itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/05/2021,8.0,PVT,Metamucil pills,None,None,,No known food or drug allergies,"['Erythema', 'Induration', 'Injection site induration', 'Injection site swelling', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 922900,HI,25.0,M,"""I work in the ED in behavioral health. I got my Covid vaccine at 12/23 1930 and I got super sick 24 hours getting my covid vaccine, I had chills and fever which I know is a normal side effect. But I had some shortness of breath which I thought was weird, I feel totally fine today""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,Unknown,None,None,,None,"['Chills', 'Dyspnoea', 'Malaise', 'Pyrexia']",1,PFIZER\BIONTECH,IM 922901,CO,37.0,F,"After receiving the vaccine, the patient ended up with a mild case of Bell's palsy. Symptoms include: mild numbness up to the maxillary bone, and a weak smile (doesn't go up on the right). Her Smile is asymmetrical.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Facial paralysis', 'Facial paresis', 'Hypoaesthesia']",1,PFIZER\BIONTECH,IM 922902,,45.0,F,"ABOUT 1020 25 MINUTES AFTER VACCINE ADMINISTRATION PATIENT FELT ITCHY ALL OVER BODY. PATIENT DESCRIBES ITCHING AS MODERATE. NO RASH NOTED. NO ANGIOEDEMA. PATIENT NO IN RESPIRATORY DISTRESS. 1028 VITALS: BP: 172/93 P: 62 SAO2: 99%. BENADRYL 50MG ORAL GIVEN AT THIS TIME. 1038 VITALS: BP: 155/99 P: 64 SAO2: 99% PATIENT DESCIBES ITCHING AS THE SAME, MODERATE. NO REDNESS AT SITE, NO RASH, NO RESPIRATORY DISTRESS. 1048 VITALS: BP: 164/108 P: 63 SAO2: 99% PATIENT TAKEN TO ER",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,,,,"ABOUT AN HOUR AFTER FLU VACCINE - ITCHING, REDNESS, SWELLING, AT INJECTION SITE. INJECTION SITE WAS VERY WARM TO TOUCH. PATIEN",THIMERESOL,['Pruritus'],1,PFIZER\BIONTECH,IM 922904,NJ,36.0,M,"Patient A&Ox3. After patient received Pfizer 0.3mL COVID-19 vaccination on left deltoid, patient reported 7 minutes post vaccination, itchy burning on left eye spreading to right eye, minor headache. Patient denies SOB, chest pain, trouble breathing. Upon assessment, noted of left deltoid was warmth, swelling, and redness. Swelling also noted on left eye with slight redness at conjunctiva Patient was medicated with 50 mg benadryl right deltoid.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,WRK,none,none,none,,"Dust- rhinitis , itchy eyes , watery eyes, redness Pollen- rhinitis , itchy eyes , watery eyes, redness","['Erythema', 'Eye irritation', 'Eye pruritus', 'Eye swelling']",1,PFIZER\BIONTECH,IM 922905,CO,33.0,F,"Employee called nurse line, had COVID vaccine left deltoid 12/23 and began having symptoms of tickle in throat, sinus headache, minor loss of smell and taste, congestion on 12/30/2020. Tested positive for COVID 1/4/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/30/2020,7.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Ageusia', 'Anosmia', 'COVID-19', 'Respiratory tract congestion', 'SARS-CoV-2 test positive', 'Sinus headache', 'Throat irritation']",1,PFIZER\BIONTECH,IM 922906,IN,28.0,M,fever and chills onset at 12:30am (13 hours post-vaccine). Fever and chills remained for approximately 17 hours. Symptoms resolved in 24 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Pyrexia']",1,MODERNA,IM 922907,NJ,47.0,F,"CHILLS , FEVER , BODY ACHES, JOINT PAIN",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,NONE,,NONE,,KNA,"['Arthralgia', 'Chills', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 922908,NJ,44.0,F,"Vaccine recipient reported that after receiving the vaccine they developed headache and discomfort going down the right side of their neck. Vaccine recipient declined treatment. The day after the vaccine recipient experienced body aches, shortness of breath, and a low grade fever. They took Advil. They did mention that they do have lymph node swelling. During a follow-up phone call on 1/6/2021, vaccine recipient reported that symptoms have resolved. Moderna COVID- 19 Vaccine EUA.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,WRK,"labetalol, hydrochlorothiazide",none,none,Vaccine recipient reports that they always have side effects when receiving any vaccine.,penicillin,"['Discomfort', 'Dyspnoea', 'Headache', 'Lymphadenopathy', 'Musculoskeletal discomfort', 'Pain', 'Pyrexia']",1,MODERNA,IM 922909,TN,59.0,F,"I had zero reaction to the injection, until 8 days later. Yesterday my injection site, right upper arm, became red (about a 3 inch by 3 inch area), swollen, severe itching, hard area at entry site, and warm to touch. Benadryl and warm compresses did help, but still having the reaction today.. I am only reporting this for your benefit for Data purposes on possible delayed reactions.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PUB,Lovastatin 40 mg,None,"Hyperlipidemia, Migraines",,"Shellfish, Penicillin, Avelox, Sulfa","['Injection site erythema', 'Injection site nodule', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 922911,WI,24.0,F,"The night of my vaccine, I went to sleep feeling fine other than mild tenderness at the injection site. However, I woke up at 2 am with chills and night sweats- before taking any tylenol or ibprofen my temperature was 99.9 degrees. I was awake from 2am-5am unable to find a comfortable body temperature.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,None.,None,None,,None,"['Body temperature increased', 'Chills', 'Injection site pain', 'Night sweats', 'Sleep disorder']",1,MODERNA,IM 922912,CA,35.0,F,"Headache, chills, body ache, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,No,No,No,,No,"['Chills', 'Headache', 'Nausea', 'Pain']",1,MODERNA,SYR 922913,IN,21.0,F,"Woke up next morning (9 am) to a very, very sore left arm. My whole body ached, felt feverish, and a headache. I took 3 tablets of 200 mg Ibuprofen in the morning. Then, I went to work where I felt nauseous and a headache and took 400 mg of Ibuprofen. I went to bed feeling better and took 400 mg of Ibuprofen before bed. I now feel a lot better, just a sore arm!",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,UNK,none,none,none,,Amoxicillin,"['Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 922914,CO,32.0,F,"Pt. called 1/6/2021 c/o a hard knot in her arm at the injection site, it was hot to touch, itchy and painful. Pt. stated she has had a prior reaction to the flu vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,PVT,Unknown,No Know,Unknown,Pt. states reaction to flu vaccine,Unknown,"['Injection site nodule', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 922915,TN,45.0,F,"Gradual increase in Sjogrens symptoms (muscle aches and pains, muscle stiffness, unable to get comfortable, unable to sleep, heavy limbs)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/31/2020,10.0,PVT,"hydroxychloroquine 200mg po daily, cyclobenzaprine 10mg po qhs, motegrity 2mg po daily",none,Sjogrens syndrome,,"allergy to skelaxin, clindamycin","['Limb discomfort', 'Musculoskeletal stiffness', 'Myalgia', 'Sleep disorder']",1,PFIZER\BIONTECH,IM 922916,MA,69.0,F,"12/22 Vaccination 12/24 sore throat, sniffles, diarrhea, malaise. Contacted PCP; Covid test; negative. Had symptoms to following Tues. Following week, felt better; 1/1/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,PVT,elloquence,,A-fib,influenza ; arm was hot and sore,"sulfa, bactrum","['Diarrhoea', 'Malaise', 'Oropharyngeal pain', 'Rhinorrhoea', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 922917,NC,35.0,F,"Developed mild tongue swelling and lips ""felt funny"". Took 1 Benadryl and symptoms improved slightly. Extended her monitoring time in clinic until symptoms subsided. No further report of symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,,,,,,"['Feeling abnormal', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 922918,CA,42.0,F,Patient developed sternal rash that rapidly extended to itching then itchy throat.MD called to assess and at that time rash extended to both arms. MD decided to transport to ED for evaluation,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Pruritus', 'Rash', 'Throat irritation']",1,MODERNA,IM 922919,ND,62.0,F,Vaccine given too early. First COVID vaccine was given on 12/20/20 and second dose was given on 01/04/21. A difference of 14 days instead of the required 21 days for the Pfizer vaccine. Patient has not reported any adverse events at this time due to the early administration of vaccine #2.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Fluoxetine 60 mg daily, triamcinaolone 0.1% cream bid prn rash, fluticasone 50 mcg/spray bid",,,,Environmental Allergens,"['Inappropriate schedule of product administration', 'No adverse event']",2,PFIZER\BIONTECH,IM 922920,FL,62.0,F,"Abnormal swelling 6 days after the vaccine. Very hot to the touch, sweats and a slight fever. The redness where I received the injection grew in size. I am being treated for an infection at the injection site with antibiotics.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,WRK,"Paroxetine, AdvilPm",None,None,,Penicillin,"['Hyperhidrosis', 'Injection site erythema', 'Pyrexia', 'Skin warm', 'Swelling']",1,MODERNA,SYR 922921,VA,58.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['No adverse event', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 922922,CA,33.0,F,Sore arm body aches fatigue nausea on and off headaches mild sore throat,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,UNK,,,,,,"['Fatigue', 'Headache', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pain in extremity']",1,MODERNA,SYR 922923,MO,41.0,F,"I received the vaccine on 12/23/20, and the reaction popped up around new years. On 1/1/21 an area on the skin became bright pink, medium hard to the touch and very warm compared to the skin around it. The area got larger and continued to spread over about two more days. Today is 1/6/21 and the skin is back to normal. I did not get a fever, chills, or any other symptom of note.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/01/2021,9.0,PVT,none,None,None,,Dextromethorphan,"['Erythema', 'Induration', 'Skin warm']",1,PFIZER\BIONTECH,IM 922924,NY,27.0,F,"PAIN AT INJECTION SITE X 2 DAYS FOLLOWING SHOT AND THEN I WOKE UP ON 12/31/20 WITH MY LEFT UPPER ARM SWOLLEN, RED, AND ITCHY FOR THREE DAYS. TODAY IS 01/06/20 AND REDNESS IS GONE BUT MY ARM IS STILL VERY ITCHY",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PVT,,,,,MILD ALLERGY TO NUTS,"['Erythema', 'Injection site pain', 'Peripheral swelling', 'Pruritus']",UNK,MODERNA,SYR 922925,NY,35.0,F,"complained of dizziness soon after receiving the vaccine. As per the worker BP went up to 190/90 and later came down to 140/?. Felt better and went home. during night had swelling of lips and eye lids, felt feverish, with soreness of left upper arm,pain 10/10 on a pain scale of 10. Felt better with Benedry and Tylenol. Came to Occupational health Servic ein the morning complaining of feeling foggy, feverish,blurred vision and head ache. Referred to Er for evaluation and management.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,Pantoprazole,None,GERD,,Shell fish,"['Dizziness', 'Feeling abnormal', 'Headache', 'Injection site pain', 'Lip swelling', 'Pyrexia', 'Swelling of eyelid', 'Vision blurred']",1,MODERNA,IM 922926,MI,26.0,M,"11:09 Pt was vaccinated with Moderna vaccine by other RN 11:10 pt honks horn to inform staff that he us feeling unwell 11:12 Nurses to scene with epi kit, EMS called over to pt car, pt pale and diaphoretic. states blurry vision, dizziness and thinks this could be his anxiety 11:15 Pt given juice and crackers. Pt states history of hypertension, anxiety, and that he has recently started a low car diet 11.17 EMS monitor displays HR 50, b/p 216/193, o2 99, blood sugar 109 11:20 HR 40, Tele displays SB 11:26 EKG 12 Lead done also displays SB 11:29 HR 66 B/P 176/157 11:31 Pt was educated to avoid 2nd dose of Moderna and concern expressed to him regarding driving and feeling faint. Pt refused EMS transport to thee hospital, states he will be waiting in his car for a moment, and signed release form.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,lisinopril,none,"hypertension, anxiety",,nkda,"['Anxiety', 'Dizziness', 'Hyperhidrosis', 'Malaise', 'Pallor', 'Vision blurred']",1,MODERNA,IM 922927,TX,32.0,F,Swollen and painful left axillary lymph node that has been present for about 2 days. This morning I developed a significant raised bright red rash at the site of injection that itches.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,UNK,"melatonin, zyrtec",,"Eczema, seasonal allergies",,Sulfa antibiotics,"['Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Lymph node pain', 'Lymphadenopathy', 'Rash erythematous']",1,MODERNA,IM 922928,GA,42.0,F,"swollen, tender and red area at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PUB,Lisinopril,none,htn,,"flagyl, macrobid","['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 922929,VA,60.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['No adverse event', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 922930,CT,30.0,M,"One week after injection, localized itching and redness occurred. Marked at roughly 2cm in diameter on left deltoid. Over 72 hours, site was sore, redness increased in size to roughly 5cm in diameter, itching, indurated and warm to touch. Regimen of ice, Motrin, Benadryl, hydrocortisone cream has not helped.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/03/2021,7.0,PVT,"Paxil Crestor Prilosec Allegra Flonase Fish oil B vitamin complex Ca, mg, zinc multivitamin",N/a,N/a,,Nkda,"['Erythema', 'Induration', 'Pain', 'Pruritus', 'Skin warm']",1,MODERNA,IM 922931,VA,36.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['No adverse event', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 922934,TX,40.0,F,"Pfizer-BioNTech COVID-19 Vaccine. Patient received COVID vaccination on 1/5/2021 and began feeling dizzy, light-headed and then had a witnessed syncopal episode with seizure-like activity, vomiting and loss of consciousness. Onset of symptoms were almost immediately following receipt of the vaccine. Patient demonstrated seizure-like activity again while in the ED. Patient received lorazepam 1 mg IV, diphenhydramine 50 mg IV, Lactated Ringers 500 ml IV bolus, NS 1000 ml bolus, potassium bicarbonate 25 mEq. Patient ED visit 0852 until 1404. Patient responded well to treatment and was discharged in stable condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Amlodipine 5 mg daily, Cetirizine 10 mg daily prn, Additional information for Item 9: Ergocalciferol 50,000 units every 14 days, hydroxychloroquine 200 mg twice daily, meloxicam 7.5 mg twice daily, norethindrone/estradiol 1mg/20mcg daily, p",,"Hypertension, GERD, Fibromyalgia, RA",,NKDA,"['Dizziness', 'Immediate post-injection reaction', 'Loss of consciousness', 'Seizure like phenomena', 'Syncope', 'Vomiting']",1,PFIZER\BIONTECH,IM 922935,VA,31.0,F,A few minutes after receiving vaccine the patient started to itch and develop hives/rash on arms. Once she was pulled to an exam room the itching worsened to her neck and chest.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Buspirone 7.5mg 1 BID PRN Tylenol 300mg-Codeine 30mg 1 PRN Depo-Provera injection Q 3 months,,H/O migraine goiter anemia,,Hydrocodone Novocain Penicillin,"['Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 922937,MA,43.0,M,"about 10-15 minutes after injection, felt tightness in throat and sore throat with a little difficulty breathing. Notified onsite RN who immediately gave him 50mg oral Benadryl. Vitals done by EMT onsite, BP `164/108, P=110, slightly swollen tongue. Did not have Pulse Oximeter until 30m after reaction. At that time, O2=94%. 15m after Benadryl patient stated he felt 80% better. 45m after Benadryl patient felt 95% better, BP = 134/96, P= 64, O2=98% and no tongue swelling. Patient wife will pick him up and drive him home. Instructed to take 50mg in 4 hours and call 911 if any symptoms return.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,"Lexapro, Vit d",none,"Anxiety/depression. As a child had asthma, but has grown out of it.",,"Currently - seasonal allergies As a child- chocolate- did have to go to ER a few times for reaction to chocolate- can't remember exact reaction. But can eat chocolate now without any issue. As a child- had cat/dog alleriges, but not severe and grew out of it.","['Dyspnoea', 'Oropharyngeal pain', 'Swollen tongue', 'Throat tightness']",1,MODERNA,IM 922939,ID,53.0,F,"Pt started with fever, Fatigue and headache at 1/6/2021 @3:00 AM",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,UNK,none,none,none,,none,"['Fatigue', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 922940,NY,35.0,F,Moderna Covid 19 Vaccine EAU Sore Arm- within 6hrs The following within 8hrs after injection. Lasted for 24-30 hrs. Relieved with Motrin and Tylenol. Dizzines Fatigue Nausea Stomach pain Sluggishness Lymph node formation in left neck.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,,,,,,"['Abdominal pain upper', 'Dizziness', 'Fatigue', 'Nausea', 'Pain in extremity', 'Sluggishness']",1,MODERNA,IM 922941,TX,27.0,F,"Patient reported ""heavy and hot flashes"" in her head, ""hot flashes"" in her ears, nasal congestion and feeling generalized ""hotness"" in her body about 30 minutes after vaccine administration. HR 74. Denied any SOB or dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PUB,unknown,unknown,unknown,,unknown,"['Feeling hot', 'Head discomfort', 'Hot flush', 'Nasal congestion']",1,MODERNA,IM 922942,NY,35.0,F,"Starting January 2, 2021 pain under arm pit and bicep area. The following next day noted redness on prior vaccination scarring. Lymph nodes felt swollen and pain when arm squeezed against chest.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/02/2021,7.0,PVT,none,none,none,,NKDA,"['Axillary pain', 'Erythema', 'Lymphadenopathy', 'Pain in extremity', 'Tenderness']",1,MODERNA,SC 922943,IL,48.0,F,"After ~30 minutes of receiving vaccine I developed tingling in my lips which progressed to numbness in my right cheek/jaw and cold, numbness and tingling in my right hand/forearm. Symptoms improved within 24 hours and were gone in 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,"Garden of Life women's multivitamin, topical skin ointment - trentoinin .25%",Celiac Disease,,,No known allergy but I do have Celiac Disease,"['Hypoaesthesia', 'Paraesthesia', 'Paraesthesia oral']",UNK,PFIZER\BIONTECH, 922944,VA,41.0,M,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,['Incorrect dose administered'],1,PFIZER\BIONTECH,IM 922945,CO,65.0,F,Patient reported experiencing extreme bruising and warmth at the injection site. Patient could not sleep on right side due to pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,,,,,zolmitriptan,"['Injection site bruising', 'Injection site warmth', 'Sleep disorder']",1,PFIZER\BIONTECH,IM 922946,MS,60.0,F,"Severe chills, mild body aches, excessive thirst for very cold drinks, temp 100.4. Rest and Advil",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Pepcid 20mg, Vit C 1000mg, Vit D2 5000 MWF, Melatonin 3mg, Magnesium 500mg",None,None,,sunflower,"['Chills', 'Pain', 'Thirst']",1,MODERNA,IM 922947,TX,69.0,F,"Temperature spike to 101F, significant chills and shaking for 60 minutes, headache, generalized body aches, nausea, very sore left arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PUB,"Metoprolol Tartrate, Telmisartan, Amlodipine, Atorvastatin, Baby Aspirin, Calcium supplement",None,"Hypertension, Asthma","Flu vaccine 2018, age 66: temp spike to 104F, chills/shaking",ACE Inhibitors--cough,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA,IM 922948,NH,31.0,F,"Started to feel like my breath was being taken away at times for a few days (started a few days prior to 1/2/2021. Also, I felt like my heart was racing and having heart palpitations. On 1/2/2021, I noticed a inflamed rash over the injection site. It was slightly warm to to the touch and slightly sore. The rash had a red line around it with red spot inside the circle. The rash was gone by the morning on 1/3/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/02/2021,10.0,PVT,"Birth Control, Allergy Medication, Calcium, ProBiotic, MultiVitamin, Vitamin D, Vitamin B Complex",,"Endometriosis, Prolactinoma, exercise induced asthma","TDAP years ago - Fever, Body Aches, Chills, Inflammed and warm injection Site. I was placed a Zpack","Salicytic Acid, Lactic Acid, Reaction to TDap shot years ago, allergic to cats, dogs, dustmites, and cockroaches","['Dyspnoea', 'Injection site inflammation', 'Injection site rash', 'Pain', 'Palpitations', 'Skin warm']",1,MODERNA,SYR 922949,OH,52.0,F,"Fever, pain below the injection site, fatigue/weakness, facial swelling; her PCP sent her to the ER for IV fluids and oral Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,SEN,None,COVID positive in the month of December,None,,Lisinopril,"['Asthenia', 'Fatigue', 'Injection site pain', 'Pyrexia', 'Swelling face']",1,PFIZER\BIONTECH,IM 922950,KY,34.0,F,"PATIENT C/O ACHINESS, CHILLS, SWEATY, NAUSEA AND FEVERISH FEELING. ONSET WAS ON THE EVENING SHE GOT THE VACCINE AND THE SYMPTOMS LASTED FOR 2 1/2 DAYS. SHE DID NOT GO TO THE DOCTOR OR TAKE ANY MEDS FOR THE SYMPTOMS. SHE DESCRIBES THE SYMPTOMS AS FEELING SIMILAR TO WHAT SHE FELT WHEN SHE HAD COVID-19 IN JUNE. SHE DID NOT GET RE-TESTED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,NONE,NONE,SHE HAD COVID-19 IN JUNE 2020,,NKA,"['Chills', 'Hyperhidrosis', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 922951,CA,23.0,F,"Within 10 minutes of receiving vaccine, patient reported dizziness, headache, SOB, & ""hard to swallow,"" light-headed, was diaphoretic. Was seen in ED, given oral Benadryl, Epinephrine, Zofran. Monitored in the ED for 5/12 hours, then discharged to home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Delaxotin, Pregamblin, Vaspirme",,"Fibromyalgia, Anxiety, Depression",,,"['Dizziness', 'Dysphagia', 'Dyspnoea', 'Headache', 'Hyperhidrosis']",1,PFIZER\BIONTECH,IM 922952,NJ,53.0,M,Pt had severe headache that started at 7:30pm after receiving the Covid vaccine and lasted for about 3.5 hours. It resolved after he took Tylenol. He also had pain at the injection site with reduced range of motion. Full range of motion came back 1/6 at 8 AM.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Lotrel,None,Colitis,MMR - hives,"Iodine, MMR vaccine, Cipro, Keflex","['Headache', 'Injected limb mobility decreased', 'Injection site pain']",1,MODERNA,IM 922953,VA,54.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['No adverse event', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 922954,IL,40.0,F,Fevers started 12 hours post vaccine. Severe arm pain. Out of proportion to previous IM vaccines.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,OTH,none,none,none,,none,"['Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH, 922956,NY,29.0,F,I had a headache for just one day.. Three days after the vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/31/2020,4.0,PVT,Levothyroxine Singular Prenatal vitamin Vitamin D Xyxal Baby Aspirin,None,Autoimmune Thyroid Disease,,None Seasonal and environmental Allergies,['Headache'],1,PFIZER\BIONTECH,IM 922957,FL,35.0,F,"Within 5-10 minutes of receiving the vaccine I began to have tachycardia and tightness in my chest and throat- airway remained clear but resembled tightness with asthma exacerbation. Dry cough developed as well at that time. Through the day severe body aches, fatigue and fever/chills developed and progressed. I was unable to sleep as a result. Today severs body aches and fever/chills continue as well as headache that does not resemble the chronic migraines I normally have. Tightness in chest and dry, nonproductive cough continue as well. I am also experiencing extreme fatigue. Injection site is hot, red, and raised- pain with left arm movement as a result.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,"zoloft, wellbutrin, celebrex, topamax er, singulair, proair, advair, b complex, vitamin c, biotin, multivitamin",none,"asthma, chronic bronchitis, chronic sinus infections, migraines",,"penicillin, amoxicillin, erythromycin, keflex, sulfonamides, bees","['Asthma', 'Chest discomfort', 'Chills', 'Cough', 'Fatigue', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Pyrexia', 'Sleep disorder', 'Tachycardia', 'Throat tightness']",1,MODERNA,IM 922958,CA,49.0,F,Pt reported tingling & mild numbness from injection site to elbow on 06Jan. Pt reported hives in a 2-3 inch diameter w/ 3-4 plaques stemming from injection site. Pt reported mild DOE on 05Jan that has resolved. Pt denies any other type of reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/05/2021,7.0,MIL,,,,,NKDA,"['Dyspnoea exertional', 'Injection site hypoaesthesia', 'Injection site paraesthesia', 'Injection site urticaria']",1,MODERNA,IM 922960,VA,55.0,M,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['No adverse event', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 922961,KS,47.0,M,"12:00pm- severe headache on R side, took Tylenol 1800- Felt fatigue 1900- Body Aches 2100- Temp 100.1, arm pain in L deltoid ""I cannot stand even the sheets touch it.""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,"Alprazolam, Amlodipine, Loratadine, Losartan, Metformin, Mometasone, Testosterone, Ergocalcif",Positive for Covid 8/25/2020,,,Lisinopril,"['Body temperature increased', 'Fatigue', 'Headache', 'Injection site pain', 'Pain']",1,MODERNA,IM 922962,CT,48.0,F,"fever 100 - 102, body aches, chills, sever nighttime sweating, intermittent nausea, severe headache, fatigue, face feeling flush for 48hours beginning approximately 3 hours post second vaccination treated with acetaminophen, ibuprofen, fluids and rest",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,"Prestiq 100mg daily, Vitamin D daily, daily fiber, glucosamine daily, lorazepam prn",,,,"Bacitracin, sulfa, bactrim","['Chills', 'Fatigue', 'Flushing', 'Headache', 'Hyperhidrosis', 'Nausea', 'Night sweats', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 922963,,38.0,F,"Client felt hot and tingling sensation up right arm. given 5ml benadryl PO. 120/70, 80 Pulse, 4 quad lungs clear upon discharge.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,,,Asthma,,"ASA, NSAIDS, Bee Venom","['Feeling hot', 'Paraesthesia']",1,MODERNA,IM 922980,IL,40.0,F,Second dose of vaccine. Unable to sleep post vaccine evening zero. Severe fatigue post vaccine day one. Headache. Arm pain out of proportion to previous IM vaccinations.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,none,none,none,submitted report of headache and arm pain out of proportion to previous IM vaccines with first COVID 19 pfizer injection,none,"['Fatigue', 'Headache', 'Pain in extremity', 'Sleep disorder']",UNK,PFIZER\BIONTECH, 922981,OR,50.0,M,"I observed in irregularly shaped raised, red, warm, and firm shape at the injection site this morning after my shower. I am also noticing a bit more soreness as I use my left arm at the injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,PVT,None,Nonr,None,,None,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 922982,TX,82.0,M,"palpitations, dizziness, chills and ""wet from head to toe"". Note; patient did not eat yet today and arrived at 5am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,"diabetes, heart condition, seizures",,,"['Dizziness', 'Feeling cold', 'Hyperhidrosis', 'Palpitations']",1,PFIZER\BIONTECH,IM 922983,VA,68.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['No adverse event', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 922984,NH,71.0,M,"Moderna COVID-19 Vaccine EUA Heart palpitations, elevation of blood pressure. Not yet treated, symptoms have not resolved. Contacted Physicians office this morning. Waiting for a return call.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,Chlorthalidone Xiidra,,Hypertension Dry eyes,,,"['Blood pressure increased', 'Palpitations']",UNK,MODERNA,IM 922985,FL,55.0,F,Pruritic rash to dorsal hands.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,"Celebrex, Synthroid, Bystolic,Dyazide, Metformin",,"HTN, Hypothyroid, DM",,"Codeine, Pecans",['Rash pruritic'],2,PFIZER\BIONTECH,IM 922986,TX,40.0,F,"Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times that same day. I also had sore throat and funny taste in my mouth. That night is when I mainly definite effects, chills, fatigue, body aches, low grade fever and head ache. Wednesday and Thursday I was in bed with fever, nasal congestion, body aches. Friday I started to feel better and function. By Saturday I was fine. Was in communication with my PCP. My daughter, 3 years old tested positive for Covid on 1/4/2021 and now I'm starting to feel bad.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,WRK,Fiber pills Melatonin (sometimes) motegrity Xiidra Taday Senacot Multi vitamin,May have had a cold when I got the vaccine,Chronic constipation and dry and inflamed eyes,Flu vaccine - had similar side effects with Covid vaccine.,,"['Chest discomfort', 'Exposure to SARS-CoV-2', 'Fatigue', 'Feeling cold', 'Headache', 'Nasal congestion', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Taste disorder']",1,PFIZER\BIONTECH,SYR 922987,NJ,46.0,F,"FEVER , ACHINESS CHILLS SEVERE JOINT PAIN",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2001,,PVT,none,NONE,NONE,FIRST COVID SHOT,NKA,"['Arthralgia', 'Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 922988,CO,50.0,F,Employee received the COVID vaccine on 12/21/2020. Employee reports her symptoms started on 12/30/2020. Employee states she cannot turn key in door or use right arm and hand normally. Employee reports parasthesias including slight numbness and tingling. Employee reports pain that is in the back of her shoulder that is rated as 2-3/10. Employee states all of her symptoms have been the same since 12/30 and have not worsened and no new symptoms had started.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/30/2020,9.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Arthralgia', 'Fine motor skill dysfunction', 'Hypoaesthesia', 'Paraesthesia']",UNK,PFIZER\BIONTECH,IM 922989,NJ,42.0,F,"12 hours after injection, developed swelling at injection site that increased over two days to be about 1 1/2 inch in diameter that slowly decreased over 1 week. Developed muscle pain in left jaw, left neck, left chest for two days. Itching at site of injection lasted about 2 weeks.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,none,none,none,,none,"['Chest pain', 'Injection site pruritus', 'Injection site swelling', 'Myalgia', 'Neck pain']",1,PFIZER\BIONTECH,IM 922990,NV,54.0,F,The patient received the vaccine indicated above. Immediately following vaccination the patient states that they began feeling lightheaded and dizzy.,Not Reported,,Not Reported,Yes,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,NKDA,,,,,"['Dizziness', 'Electrocardiogram', 'Immediate post-injection reaction']",UNK,MODERNA,IM 922991,NY,61.0,M,5 days later December 31st Noticed weakness on my left side of my face. Tearing on the left eye . Unable to open wide on my left lips,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/31/2020,5.0,OTH,Bydureon BCise 2mg/ once a week Amlodipine 10mg / day Lisinopril 40my/day HCTZ 10mg/ day Protonix 10mg/ day Naltrexone 50mg/ day Vitamin D Multivitamin,None,Diabetes 2 Hypertension Sleep Apnea,,None,"['Blood test', 'Facial paresis', 'Hemiparesis', 'Lacrimation increased']",1,PFIZER\BIONTECH,IM 922992,IN,65.0,F,"Had severe chills that began about 8 pm on 1/5/2021. Had chills all night, and muscle aches began around midnight. When I woke to get a shower around 5:30 am on 1/6/2021, I was extremely lightheaded and laid down on the bathroom floor to keep from passing out and falling. The lightheadedness did not improve and my husband was able to help me back to bed. I was unable to overcome the chills and lightheadedness even with lying down, until about 10 am. I am able to sit up but still some what lightheaded and chills are beginning to fade. I do not feel I would be able to walk more than a few feet or drive at this time due to ongoing symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Metoprolol succinate ER,none,Supraventricular tachycardia,,Rash/hives with penicillin and with sulfa drugs.,"['Chills', 'Dizziness', 'Impaired driving ability', 'Mobility decreased', 'Myalgia']",UNK,MODERNA,IM 922993,CO,71.0,F,Delayed onset of warmth and redness at injection site appearing 9 days after injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,PVT,Unknown,Unknown,Unknown,,"Alatrofloxacin High 12/06/2016 � Rash Penicillins High 12/06/2016 � Hives As a child, tolerated cephalosporins since Sulfa (sulfonamide Antibiotics) High 12/06/2016 � Hives As a child Calcitonin,salmon,synthetic Not Specified 12/06/2016 � Doxycycline Hyclate Not Specified 12/06/2016 � Liraglutide Not Specified 12/06/2016 � Allopurinol Low 12/06/2016 � Itching Bimatoprost Low 12/06/2016 � Itching","['Injection site erythema', 'Injection site warmth']",UNK,MODERNA,IM 922994,MN,32.0,F,"One day after vaccine (12/25/20) patient woke up with ringing in her ears, echoing, and diminished hearing. Ringing subsided 12/26/20 but diminished hearing continued. Seen by ENT 12/30/20 and diagnosed with hearing loss, right, with restricted hearing, left.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/25/2020,2.0,WRK,,,,,Amoxicillin- nausea and vomiting,"['Deafness unilateral', 'Hypoacusis', 'Otoacoustic emissions test', 'Tinnitus']",1,PFIZER\BIONTECH,IM 922995,NE,38.0,F,"Pt became ill around 9pm with chills and felt like her body was on fire and was burning up. No temperature at that time. Woke up around 2p and temp orally was 102.7. Stated had trouble breathing and when walking, felt uncoordinated and legs were weak .Had to hug the wall to get to the bathroom where she vomited. Called ER and was advised to come in with shortness of breath. Stated oxygen level was ok, but was admitted for fluids and monitoring. Stated the symptoms were 10 times worse than when had COVID approximately 3 weeks ago. States CXR showed some residual pneumonia.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/05/2021,4.0,PUB,Lexapro Tylenol Ibuprofen,Pneumonia 11/2020 COVID 12/14/2020,,,,"['Burning sensation', 'Chills', 'Dyspnoea', 'Feeling abnormal', 'Feeling hot', 'Muscular weakness']",UNK,MODERNA,IM 922996,AZ,30.0,F,I had ear pain on the right side at 4 am and by 8am my right side of the lip had gone numb.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,UNK,I take zoloft and birth control.,No,No,,I have shellfish allergies,"['Ear pain', 'Hypoaesthesia oral']",1,MODERNA,IM 922997,VA,49.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,['Underdose'],UNK,PFIZER\BIONTECH,IM 922998,OH,45.0,F,"diarrhea, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,SEN,"Ibuprofen, Aleve",None,None,,"Sulfa, PCN","['Diarrhoea', 'Fatigue']",1,PFIZER\BIONTECH,IM 922999,IN,54.0,F,"Temp 101.9, body aches, headache for 36 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Prilosec daily,None,None,,Nka,"['Body temperature increased', 'Headache', 'Pain']",2,PFIZER\BIONTECH,SYR 923000,PA,55.0,F,"Severe right lower quadrant pain, anorexia over 12 hours. Went to the emergency department. Lab results showed elevated WBC and CT scan showed acute appendicitis. Admitted for urgent surgery: laparoscopic appendectomy. Was hospitalized from 12/26/20-12/28/20.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,12/17/2020,12/26/2020,9.0,PVT,Valtrex Wellbutrin Abilify Fish Oil Multi-Vitamin Biotin,None,None,,None,"['Abdominal pain lower', 'Appendicectomy', 'Appendicitis', 'Computerised tomogram abnormal', 'Decreased appetite', 'Laparoscopic surgery', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 923001,CO,45.0,F,"Per patient: ""Side effects experienced with the vaccine obtained on Sat 1/2/2021. I had had covid in August 2020 and received the shot then experienced a strong reaction. Fever of 100-101 for two days, extreme arm pain at injection site for 3 days with swelling and redness, body aches for 3 days, joint and fingers swollen for 2 days. Headache continues still at 5 days and time of this report. Most notably is that my left thigh and gluteus has gone numb. This also happened when sick in August but not to the extreme that it is now. The area of the hip bone is predominately the most numb and sore. This was not the injection site.""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,,,Patient reports having covid in August 2020.,,,"['Arthralgia', 'Headache', 'Hypoaesthesia', 'Injection site pain', 'Joint swelling', 'Pain', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 923002,NY,39.0,F,headache itchiness that started at my neck and head and has spread throughout most of my body. It is not unbearable but it is uncomfortable. I have had no treatment and am monitoring at home.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,wellbutrin klonopin Latuda Viibryd,None,depression anxiety,Fever and chills with Flu vaccine in 2005,None,"['Headache', 'Pruritus']",1,MODERNA,IM 923003,ID,36.0,M,Underarm lymph nodes swollen about the size of a baseball. Also had fever and muscle soreness. Tried using ice and ibuprofen. Neither were effective in treating swollen lymph nodes. Tylenol was effective in testing fever and muscle soreness. Will see physician later today.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,UNK,"Levothyroxine, atorvastatin, cetrizine",,,,NKMA,"['Lymphadenopathy', 'Myalgia', 'Pyrexia']",1,MODERNA,SYR 923004,NY,38.0,F,Increased heart rate/ palpitations within 2 minutes of receiving vaccine that lasted approximately 20 minutes,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,None,None,Migraines,,None,"['Heart rate increased', 'Palpitations']",1,PFIZER\BIONTECH,IM 923005,NY,35.0,F,On Jan 2 I noted bicep pain and under arm pit. The following day redness started to appear on previous scarring from vaccine. The lymph nodes felt swollen and painful.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/02/2021,7.0,PVT,none,none,none,,no known allergies,"['Axillary pain', 'Erythema', 'Lymph node pain', 'Lymphadenopathy', 'Pain in extremity']",1,MODERNA,SC 923006,IA,36.0,F,"Patient called clinic the day of receiving COVID19 vaccine to report she is having numbness and tingling that goes down her arm and into her fingers that hasn't gone away. Took ibuprofen 800mg at 1045 the morning of injection. Injection was in left arm. Reports injection site looks fine, no signs of erythema, ecchymosis, or swelling. Can palpate radial pulse. Normal ROM in arm, hand, and fingers. Reports normal cap refill in fingers.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,Xulane CHC,,,,,"['Hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 923007,MO,56.0,F,"approx. 10 min after infection my heart started pounding in my chest, felt dizzy and weak. Was monitor for 45 min, blood pressure was stable , heart rate 120s. Was taken to ER, took 2 person assist to transfer to cart because I felt very weak, like I was going to pass out. In ER was given liter of fluid, Benadryl 25mg ivp. After about 45 min my symptoms started improving. By 90 mins later I was able to walk out of the ER",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,none,none,none,,"PCN, Estrogen,lyrica","['Asthenia', 'Chest X-ray normal', 'Dizziness', 'Electrocardiogram normal', 'Laboratory test normal', 'Palpitations']",1,MODERNA,IM 923008,TX,32.0,F,"1/7/21 at 08:00 body chills and at 09:30 fever (Tmax 100.5 no meds taken), at time of call 11:00 temperature of 99.1",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Chills', 'Pyrexia']",2,PFIZER\BIONTECH,IM 923009,CO,66.0,F,"Area of erythema and swelling 2.5 cm x 3 cm below injection site. Warm, mild tenderness and itching. Resolved after 5 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/01/2021,6.0,PVT,None,None,None,Influenza,Influenza vaccine,"['Injection site erythema', 'Injection site swelling', 'Pruritus', 'Skin warm', 'Tenderness']",1,MODERNA,IM 923010,VA,53.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,['Underdose'],UNK,PFIZER\BIONTECH,IM 923011,KY,45.0,F,"Patient had chest pain post administration of vaccine. Patient attributed this to heartburn after eating a large meal just before getting her vaccine (though she didn't typically get heartburn). Since the pain continued to persist her BP was taken and was 160/110. Patient said it may also be nerves but she didn't feel particularly anxious. She also stated she hadn't had her BP medication that morning. Patient took a couple of Tums and her BP was rechecked a few times. Each time the BP stayed above what the patient said was her normal even without BP medication. Due to the persistence of her hypertension and chest discomfort she was taken to the ED to be evaluated. Once patient was in ED she had an EKG, CBC with diff, CMP, and troponin. Provider eventually ruled it as an anxiety reaction (not cardiac related).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/06/2021,4.0,PVT,,,,,,"['Anxiety', 'Chest discomfort', 'Chest pain', 'Electrocardiogram', 'Full blood count', 'Hypertension', 'Metabolic function test', 'Troponin']",1,MODERNA,IM 923012,CO,48.0,F,"Minor hives, tired, runny nose, chills for about 12 hours starting approximately 3 hours after vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Gabapentin, Losartan, Vitamin D, Daily Vitamin, low dose Aspirin",,,,"Amoxicillin, Penicillin, Erythromycin, Ibuprofen, zucchini","['Chills', 'Fatigue', 'Rhinorrhoea', 'Urticaria']",1,MODERNA,SYR 923013,CO,45.0,F,"Per patient: ""Side effects experienced with the vaccine obtained on Sat 1/2/2021. I had had covid in August 2020 and received the shot then experienced a strong reaction. Fever of 100-101 for two days, extreme arm pain at injection site for 3 days with swelling and redness, body aches for 3 days, joint and fingers swollen for 2 days. Headache continues still at 5 days and time of this report. Most notably is that my left thigh and gluteus has gone numb. This also happened when sick in August but not to the extreme that it is now. The area of the hip bone is predominately the most numb and sore. This was not the injection site. """,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,,,Patient reports having covid-19 in August 2020.,,,"['Headache', 'Hypoaesthesia', 'Injection site pain', 'Injection site swelling', 'Joint swelling', 'Pain', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 923014,NC,30.0,F,"Fever, joint and muscular pain, headache, chills. Receive shot at 3o?clock in the afternoon and symptoms didn?t start the show until 10 o?clock that evening.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,SEN,Prozac,Coronavirus,Anxiety,,Symbyax,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 923015,MI,57.0,F,"Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness",Not Reported,,Yes,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,Fish oil Vitamin D3 CQ10 Wellbutrin Multivitamin Magnesium Emergent C gummies,Muscular Dystrophy,Muscular Dystrophy,,Tetracycline Strawberries Milk Chocolate Statins,"['Asthenia', 'Blood test', 'Dizziness', 'Dysphonia', 'Electrocardiogram abnormal', 'Headache', 'Heart rate increased', 'Rash', 'Throat irritation', 'Tremor', 'Urine analysis']",1,PFIZER\BIONTECH,IM 923016,MT,48.0,M,"January 1, 2021 about 7:00 p.m. Patient experienced sudden onset of ""sciatic pain."" Pt normally has recurring similar pain, but describes this as more severe. Pain extended from R hip to neck. On the morning of January 2nd, painful muscle spasms extended from lower back, mid back, between shoulder blades and neck spasm on right side, radiating to spine. Patient used ibroprofen and Tylenol. Tylenol provided some relief. Pain so severe, patient reports difficulty breathing due to spasm pain. No further respiratory distress. January 3, 2021 in the afternoon, patient reported to Emergency Department for evaluation. Was given toradol. Prescriptions for Flexeril and hydrocodone were given. As of 1/6/2021, patient is still on meds and reports improvement. However, 1/5/21 significant swelling and slight pain began in Left knee, restricting range of motion.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PVT,,None,None,,None,"['Arthralgia', 'Dyspnoea', 'Joint range of motion decreased', 'Joint swelling', 'Muscle spasms', 'SARS-CoV-2 test negative', 'Sciatica']",1,MODERNA,IM 923017,OH,52.0,F,All over body pain and chills 30 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Celexa,none,none,,PCN,"['Chills', 'Pain']",1,MODERNA,IM 923018,MI,44.0,F,Patient had a severe allergic reaction that required a dose of 50mg Benadryl and 2 doses of epi-pen 0.3mg. 911 was called and EMS arrived.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,SEN,,,asthma,,"sulfa, morphine, codeine, gelatin",['Hypersensitivity'],1,MODERNA,IM 923019,MO,41.0,F,"swollen, very painful lymph node in right arm pit that began about 36 hours after receiving vaccination and lasted for about 48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/04/2021,2.0,WRK,"Larin birth control, celexa 20 mg, nexium 20 mg, claritin 10 mg",none,none,,NKA,"['Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 923020,VA,33.0,M,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['No adverse event', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 923021,TN,71.0,F,Fever 1.07 Uncontrollable Chills Exhausted Diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,SEN,Thyroxin,none,none,,none,"['Chills', 'Diarrhoea', 'Fatigue', 'Pyrexia']",UNK,MODERNA, 923022,NE,19.0,F,"Got very nauseous, got headache with nausea, friend drove her home, got home laid in bed, grandma took temperature and temperature was 104.5. Grandma had called hospital who told individual to come in.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PUB,,,asthma,,lactose intolerant,"['Headache', 'Nausea']",1,MODERNA,IM 923023,IN,53.0,F,"Bad Headache, lasting 6 hours or longer. Took 2 pills Equate Acetaminophen 500mg at time of onset and helped ease some but did not take it away. Went to bed early and woke up next morning fine. no more headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,none,none,High Blood Pressure,,pennicellins,['Headache'],1,PFIZER\BIONTECH,SC 923024,CT,47.0,F,"Woke up following morning with headache, chills and generalized aches. That night, chills, headache, and diffuse burning sensation on skin. on 12/25/20 - developed rash on neck, face and upper chest. Other symptoms improved, but rash continued for a few days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,None,Covid + 6 weeks prior to vaccine,None,,"Amoxicillin, doxycycline Raw fruits/vegetables - apples, peaches, pears, carrots. Almonds, walnuts Soy","['Chills', 'Headache', 'Pain', 'Rash', 'Skin burning sensation']",1,MODERNA,IM 923025,NJ,52.0,F,"Vaccine recipient reported that they received the vaccine on 12/29/2020. On the same day they developed soreness at the injection site which became better the next day. On 1/2/2021 they reported that their left armpit lymph node became swollen and painful which was very concerning, They made an appointment with their primary care provider. They reported on 1/5/2021 that the left armpit lymph node is slightly better. Moderna COVID- 19 Vaccine EUA",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,WRK,none,none,none,,"amoxicillin, erythromycin","['Full blood count', 'Injection site pain', 'Lymph node pain', 'Lymphadenopathy', 'Metabolic function test']",1,MODERNA,IM 923026,VA,55.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,['Incorrect dose administered'],1,PFIZER\BIONTECH,IM 923027,NY,27.0,M,Moderna COVID-19 Vaccine EUA Rash on right deltoid formed 8 days after receiving the Moderna COVID19 vaccine. Was not itchy or painful or abnormally warm to touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,none,none,none,,none,['Rash'],1,MODERNA,IM 923028,VA,46.0,F,"Moderna COVID-19 Vaccine EUA Patient report: I was vaccinated 12/28/2020. I had very mild face itching the day after the vaccine that could have easily been to something else since I am a highly allergic person anyway. On 1/5/2020 I developing itching, bruising, welts, heat and slightly hard (firm but still a little squishy) around the injection site. Approximately 3in x 2in. She did not feel it was cellulitis as she was familiar with this but will continue to monitor for progression of symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,,,,,"alpha-gal (beef, pork, lamb, any mammal) - anaphylactic peanut, tree nut, soy - anaphylactic celery, carrots - highly allergic, angioedema","['Injection site bruising', 'Injection site induration', 'Injection site pruritus', 'Pruritus', 'Urticaria']",1,MODERNA,IM 923030,CA,38.0,M,Headache on right side but is now gone Chills No fever Muscle pain in right side of neck. Can barely move neck. Feels like it needs to be supported in a brace.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Chills', 'Headache', 'Musculoskeletal discomfort', 'Myalgia']",1,PFIZER\BIONTECH,SYR 923031,LA,31.0,F,Worsening arm pain after injection that eventually resulted in my being diagnosed with a blood clot in the arm that I recevied the injection on,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,"Yaz, Adderall, Lexapro, trazodone, Hizentra (had not taken this in 2 weeks)",None,"IGG Deficiency, ADHD, GAD",,Penicillin,"['Pain in extremity', 'Thrombosis', 'Ultrasound Doppler abnormal']",1,PFIZER\BIONTECH,IM 923032,AL,63.0,M,"Immediately following injection, area surrounding injection site began swelling. Site was bright pink and was approximately 4-5cm in size. Swelling considered moderately severe. Swollen area was not centered directly around infection site but slightly above. Area was iced and patient was given 50mg Benadryl po and monitored for additional 30 minutes for any additional adverse affects. Patient was given instructions on to call 911 for any additional severe reactions and to call clinic to report any other non life-threatening reaction. Note: Patient is a physician and is familiar with reactions and side effects to report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,UNKNOWN,UNKNOWN,UNKNOWN,,NKA,['Injection site swelling'],1,MODERNA,IM 923033,MD,57.0,F,Patient c/o tongue swelling minutes after vaccine. Also c/o itchy throat. No shortness of breath. given IM Benadryl and symptoms resolved. Previous similar reaction to crab.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,,,,,crab,"['Swollen tongue', 'Throat irritation']",1,PFIZER\BIONTECH,IM 923034,VA,48.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,['Incorrect dose administered'],1,PFIZER\BIONTECH,IM 923036,TX,49.0,F,"Dizziness, nauseous, headache, symptoms felt worse later in the day, chills. Went to ER same night and was given Tamiflu after testing positive for Flu.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PUB,"Metformin 250 mg, Lisinopril/Hctz, Atorvastatin 20mg, Vitamin D2, multivitamin",,type 2 diabetes,,,"['Chills', 'Dizziness', 'Headache', 'Influenza virus test positive', 'Nausea', 'SARS-CoV-2 test negative']",1,MODERNA,IM 923037,OH,58.0,M,"diarrhea, chills, sinus drainage",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,SEN,"Ziagen, Neverpine, Stiloto, HCTZ, Clonidine patch, hydrocortisone, albuterol, vitamin D","COPD, primary/secondary adrenal insufficiency, HIV, hypertension, asthma, emphysema","COPD, primary/secondary adrenal insufficiency, HIV, hypertension, asthma, emphysema",,Sulfa,"['Chills', 'Diarrhoea', 'Sinus operation']",1,PFIZER\BIONTECH,IM 923038,KY,31.0,F,"Day 1: soreness at injection site Day 2: rash developed on left side of neck, shoulder and underarm, extremely itchy, swollen lymph nodes to left side of neck Day 3: rash is still itchy and present Day 4: I felt normal Day 5: spontaneous, severe left arm weakness, pain and numbness tingling to fingers withexcrutiating pain to joints and muscles Day 6: muscle aches still present, less severe, mild tingling to left arm extremities Day 7: notibale localized pain to rt breast, lymph nodes swollen, very tender to the touch",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,None,None,None,,None,"['Arthralgia', 'Breast pain', 'Hypoaesthesia', 'Injection site pain', 'Lymph node pain', 'Lymphadenopathy', 'Muscular weakness', 'Myalgia', 'Pain in extremity', 'Paraesthesia', 'Pruritus', 'Rash']",1,MODERNA,IM 923039,VA,33.0,F,"I received the first dose of the Moderna COVID vaccine; My L arm is still bright red, swollen, and very itchy. It has been 8 days;",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PUB,,,,,Coconut,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 923040,OH,60.0,F,"Tingling of toes and finger on the on side of body vaccine occurred, light headed, HEAD ACHE",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,WRK,"amlodipine 10mr, rosuvastatin 10mg",None,"High Blood Pressure, High Cholesterol",,"Amoxicillin, sulfa, Asia pear, freshly cut grass, dog wood pollen, black walnut pollen","['Dizziness', 'Headache', 'Paraesthesia']",1,PFIZER\BIONTECH,SYR 923041,NY,42.0,F,"clamy, flushed",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,nka,"['Cold sweat', 'Flushing']",1,MODERNA,IM 923042,IN,24.0,F,Soreness and redness at injection sight persisting 2 days post vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Albuterol inhaler 2 puffs PRN,,Exercise-induced Asthma,,,"['Injection site erythema', 'Injection site pain']",UNK,MODERNA,IM 923043,,45.0,F,"Patient stated she started having symptoms < 5 minutes after receiving the vaccine (while waiting), she initially had significant headache (which has now resolved), full-body itching, some throat irritation, and lacrimation. Patient also noticed swelling in her bottom lip. Patient states she's only allergic to pineapple, has never reacted to vaccines before, and states she's never had anaphylaxis before this. She does not carry an Epi pen with her regularly."" Patient also had chest tightness, sore-throat/neck muscles. Patient was given Epi, benadryl IV, decadron IV, and bolus fluid. She was monitored for 4 hours and discharged once stable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Ibuprofen 600 mg po Q6H PRN mild pain. Tramadol 50 mg po Q6H PRN Severe pain.,,,,Pineapple,"['Chest discomfort', 'Headache', 'Lacrimation increased', 'Lip swelling', 'Oropharyngeal pain', 'Pruritus', 'Throat irritation']",1,PFIZER\BIONTECH,IM 923044,CA,36.0,F,"Muscle inflammation, redness, warmth, itchiness and mild pain/soreness at injection side >1 week post injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,None,None,None,,NKDA,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Myositis']",1,MODERNA, 923045,PA,35.0,F,I woke up with significant vertigo and nausea. The vertigo subsided after about 30 minutes. The nausea continued throughout the day. Increased nausea with looking down or quick movements throughout the day. Headache that day as well. Intermittent mild nausea the following day. No other sick contacts.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/02/2021,5.0,PVT,none,none,none,,none,"['Headache', 'Nausea', 'Vertigo']",UNK,PFIZER\BIONTECH,IM 923046,VA,28.0,M,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['No adverse event', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 923047,IN,19.0,F,I have been experiencing intense nausea and vomiting the day after receiving the vaccine. Nothing has been able to treat the nausea.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Divalproex Buspar Wellbutrin Seroquil Adderall Topamax Folic acid Omeprazol,,Mental illness,,,"['Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 923048,ME,66.0,F,"Swelling, redness at injection site appearing on Day 9",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/04/2021,9.0,PVT,"Losartan, sertraline",none,depression,,"Codeine, oxycodone, cephalosporins","['Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 923049,TN,24.0,F,"2-3 hours after vaccination developed a ""weird feeling"" or brain fogginess. At 1545 she developed body aches, chills, dizziness, and chest tightness prior to falling asleep on her couch. She woke up drenched in sweat and took some Emergen-c. Overnight she developed a headache which woke her up and she took Excedrin. This AM se continues to have body aches, dizziness, and a slight headache, but denies feeling any disorientation now.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Took Emergen-C and Excedrin,None; COVID positive 10/12/20,None,,Topamax,"['Chest discomfort', 'Chills', 'Dizziness', 'Feeling abnormal', 'Headache', 'Hyperhidrosis', 'Pain']",1,PFIZER\BIONTECH,IM 923051,,60.0,F,"Injection site appears infected. Thickened, red, skin dimpled. Day 8 since Injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,,,,,Sulfa antibiotics,"['Erythema', 'Injection site infection', 'Skin hypertrophy', 'Skin indentation']",1,MODERNA,SYR 923052,OK,41.0,F,"approximately 40 minutes after receiving the vaccine she became flushed, sweaty, dizzy. Then about 1 hour after vaccine she had a headache. I took her blood pressure, it was 158/83, Pulse 92, Respirations 20, not shortness of breath or respiratory difficulty noted. She laid down and continued to feel the same way after 2 hours post vaccination. Her husband picked her up and she went home to rest for the day. She was given instructions on when to seek medical attention and to call me later today to let me know how she is feeling.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,OTH,she did not report taking any medications or anything else,none reported,"history of hypothyroidism per patient, has not taken any thyroid medicine in several months",,NKA,"['Dizziness', 'Flushing', 'Headache', 'Hyperhidrosis']",1,PFIZER\BIONTECH,IM 923053,VA,41.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,['Incorrect dose administered'],1,PFIZER\BIONTECH,IM 923054,IN,38.0,F,"dizziness, fatigue, arm soreness, myalgia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,UNK,none,covid infection diagnosed 12/24/20,none,,none,"['Dizziness', 'Fatigue', 'Myalgia', 'Pain in extremity']",1,PFIZER\BIONTECH,SC 923055,CA,37.0,F,"Hard mass/swelling in left arm with redness at/near injection size (about the size of three fingers) and a ""stretching"" (sore/numb) sensation upon lifting of the arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,None,No known illnesses.,Migraine,,No known allergies.,"['Injection site erythema', 'Injection site hypoaesthesia', 'Injection site mass', 'Injection site pain', 'Injection site swelling']",1,MODERNA,SYR 923057,MN,41.0,F,"Patient had history of feeling dizzy/faint from needle pokes. She thought she'd be alright- but 5 minutes after the vaccine, she got very pale and lightheaded. Staff eased her onto the floor (she did not faint or lose consciousness) and staff raised her feet up on a chair. Then after about 5 minutes on the floor, we had her sit up and helped her to a cot- continued to lay down another 15 minutes. She also had not eaten or had anything to drink yet that day (she was vaccinated at 11:15am). Given apple juice, which also helped her body recover. No injury was sustained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,not aware,none,Previous lightheadedness with needles/vaccines/blood draws,Not sure which vaccine- has fear of needles in general,no knowns allergies,"['Dizziness', 'Pallor']",1,MODERNA,IM 923058,GA,48.0,F,"Temp of 101, severe headache, joint pain, large golf ball size knot with heat and redness at injection site, joint pain, eso left shoulder, nausea and vomiting.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,MIL,"HCTZ 25mg daily, Zoloft 50 mg daily and Singulair 20mg at night and Symbicort 160mg 2 puffs twice daily",None,"Asthma, history of breast cancer requiring mastectomy to right side, lymph removal and 16 months of chemo in 2013. Obese Insomnia",Cellulitis to Afluria,I had a cellulitis in 2017 that progressed when given the Afluria vaccine.,"['Arthralgia', 'Body temperature increased', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site warmth', 'Nausea', 'Vomiting']",1,MODERNA,IM 923059,OH,59.0,F,"12/31,2020 5PM developed a fever 0f 102. Right arm was swollen and hot, I was slightly nauseated. Reaction lasted approximatetly 3 hours and abated. I had a similar reaction on January 1,2,3 2021 .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"claritin, potassium,zinc, vitamin C and just prior to vaccine Benadryl and ibuprofen",none,"asthma,menieres syndrome",Pneumonia vaccine cant remember details of date or type,"sulfa meds,albuterol, Numerous environmental allergies","['Nausea', 'Peripheral swelling', 'Pyrexia', 'Skin warm']",1,MODERNA,IM 923060,TX,43.0,F,"12/24/20 0900 - site soreness, 1100 body aches, chills, 1300 low grade temp, 1430 102.5 temp, temp continuing to rise to 104, headache 12/25/20 continue with fever and body aches, dizziness, headache (unresolved with naproxen, maxalt, tylenol), significant site pain and lymphadenopathy and pain to right axilla 12/26/20 fever resolved, headache resolved by about 1400. 12/27/20 lymphadenopaty/axilla pain resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,,"COVID symptoms day 11/20/20, tested positive 11/22/20",recent elevated glucose,,None,"['Axillary pain', 'Body temperature increased', 'Chills', 'Dizziness', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Pain']",1,MODERNA,IM 923061,MD,53.0,F,"Woke in middle of night with chills fever and severe body aches that lasted until 2100 on 12/29/2020. Arm at injections site red swollen, hot to touch and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,PVT,Janumet,Diagnosed covid 12/3/2020,Diabetes,,Isoniazid - rash Possibly partial reaction to eggs,"['Chills', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 923062,PA,41.0,F,"Broke out in red rash on neck, chest and arms. Lips itchy and tinging.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,,,,,,"['Lip pruritus', 'Paraesthesia oral', 'Rash', 'Rash erythematous']",1,PFIZER\BIONTECH,IM 923063,NV,44.0,F,Fever chills headache body ache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,N/a,N/a,N/a,,N/a,"['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,MODERNA,SYR 923064,CA,36.0,F,"Soreness, redness, inflammation, itchiness at injection site >1 week post injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,None,None,None,,NKDA,"['Injection site erythema', 'Injection site inflammation', 'Injection site pain', 'Injection site pruritus']",1,MODERNA, 923065,CO,27.0,F,R axillary lymph node swollen and painful to touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/29/2020,7.0,PVT,"Albuterol as needed, Zyrtec, adapalene gel, Xolair injections 1x/month",,"Asthma, cold urticaria",,"Suprax, peanuts, the cold(cold urticaria)","['Lymphadenopathy', 'Tenderness']",UNK,MODERNA,SYR 923066,IL,48.0,M,"Left axillary lymph node swelling. I am treating the swelling with Motrin 400 mg daily, and Tylenol 1000 mg daily for pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/03/2021,4.0,WRK,No,No,No,,NO,['Lymphadenopathy'],1,MODERNA,IM 923067,MO,32.0,F,"I had fatigue, headache and muscle aches. Just last night, for a short period of time, I had muscle aches and chills. I am 34 weeks gestation with a estimated deliver date of 02/10/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,UNK,"I take a prenatal vitamin, buspar, levothyroxin",No,No,,I am allergic to sulphur,"['Chills', 'Fatigue', 'Headache', 'Myalgia']",1,MODERNA,IM 923068,VA,52.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,['Incorrect dose administered'],1,PFIZER\BIONTECH,IM 923069,MN,32.0,M,"Fatigue, muscle pain, joint pain, chills, nausea, and fever. Observed 9am juts 25 hours after dose 1. Fever normal at 9am, 10:30 - 100.6,and 11:30am - 101.4.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SCH,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,SYR 923070,,26.0,F,"As per the patient, her lips were swollen the night and the morning after the vaccine. I as the vaccinator did not witness this reaction when patient was asked to stay 15mins for monitoring post vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/24/2020,1.0,PVT,,,,,,['Lip swelling'],UNK,PFIZER\BIONTECH,IM 923071,NJ,33.0,F,"Vaccine was administered too high on the left arm, near the top of the shoulder, and was likely not administered in the deltoid muscle. At this time, symptoms include muscle pain and soreness at shoulder and limited range of motion, as well as pain when applying pressure to injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,,,,,Latex,['Product administered at inappropriate site'],1,MODERNA,IM 923072,WI,34.0,F,"She has had intermittent fatigue since receiving the vaccine, which is slowly improving. She had significant pain after receiving the vaccine which resolved in a day or two. She was unable to move the arm the evening after receiving the vaccine (feeling completely asleep), but has gained full strength. She continues to have paresthesias (like the arm feeling asleep or bugs crawling) to the forearm and her entire hand. She did take diphenhdyramine and isn't certain if it improved the paresthesias, but it did make her fall asleep. Two to three days ago (about 6 days after receiving the vaccine), she developed a cellulitis about 5 cm distal to the vaccine site without systemic symptoms for clinically apparent abscess.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,"Fluoxetine, melatonin",None,,,None,"['Fatigue', 'Injected limb mobility decreased', 'Injection site cellulitis', 'Pain', 'Paresis']",1,MODERNA,IM 923073,IN,36.0,F,"Nausea, headache, diarrhea, nightsweats, sore throat and swollen lymph notes causing difficulty swallowing x 2 days (took ibuprofen) Multiple fever blister outbreaks since receiving vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/26/2020,0.0,PVT,"Zoloft, vitamin",None,Scoliosis,,"Latex, tramadol, cats","['Diarrhoea', 'Dysphagia', 'Headache', 'Lymphadenopathy', 'Nausea', 'Night sweats', 'Oral herpes', 'Oropharyngeal pain']",1,PFIZER\BIONTECH,SYR 923074,NJ,25.0,F,"Pt developed swollen lymph node on left side of neck on 1/3. She went to Urgent Care, and lab work is pending. Covid test was negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,PVT,Singulair,none,none,,"Gluten meal, oxycodone, sulfa antibiotics","['Lymphadenopathy', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 923075,VA,35.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,['Incorrect dose administered'],1,PFIZER\BIONTECH,IM 923076,CT,43.0,F,Pt reported itchiness to her body and dizziness.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,none,unknown,unknown,,none,"['Dizziness', 'Pruritus']",1,PFIZER\BIONTECH,IM 923078,NE,75.0,F,"20 minutes after receiving the vaccine, this patient began noticing a lot of swelling in her hands. She has a history of anaphylaxis to many environmental allergens as well as medications. She felt hot/ sweaty/ upper & lower extremity swelling/ gait was unsteady/ itchy swollen eyes/ headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Premarin, Metoprolol, antidepressant, potassium, magnesium, D3, aspirin",,"Depression, chronic kidney stones, Afib,",,"Peanuts, PCN, Keflex, Zofran, Norco, CT dye, tomato, onion, mushrooms","['Eye pruritus', 'Eye swelling', 'Feeling hot', 'Gait disturbance', 'Headache', 'Hyperhidrosis', 'Peripheral swelling', 'Swelling']",UNK,MODERNA,IM 923079,TX,55.0,F,"I woke up with diarrhea, vomiting (several times) and chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/02/2021,2.0,WRK,"Synthroid 0.1 MG TAB, Advair Diskus 100/50, Candesartan/HCT 32-25MG TAB, Aubagio 14MG TABS, Nasacort, Multivitamin supplement, Vitamin B12, Vitamin D3, Estroven, Fexofenadine, Emeprazole, Turmeric",None,"MS, Grave's Disease (post-ablation hypothyroidism), HTN, Asthma",,Seasonal allergies,"['Chills', 'Diarrhoea', 'Vomiting']",1,MODERNA,IM 923080,,40.0,F,"Arm soreness, mild fatigue but she is overall okay",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,PVT,Vitamins,,,,,"['Fatigue', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 923081,IN,40.0,F,"Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), symptoms improved after 32 hours. Loss of voice at 42 hours but has since came back.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,None,None,Thyroid Mass,,"Seafood, avacodo, seasonal allergies","['Aphonia', 'Arthralgia', 'Asthenia', 'Chills', 'Nausea', 'Pyrexia', 'Urticaria']",4,PFIZER\BIONTECH,IM 923082,CT,52.0,F,mild headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,Telemisartan 40mg Amlodipine 10mg,none,high blood pressure,,none,['Headache'],2,PFIZER\BIONTECH,IM 923083,CO,58.0,F,"Approximately 10 minutes after vaccination patient complained of feeling dizzy. Brought into clinic room and laid down. Patient given juice, which she drank but then threw up about 1 minute after drinking. Patient complained of feeling dizzy, hot, and having a headache. She remained conscious but continued to stay laying down for about 20 minutes. Patient was given a cold, wet cloth for her head, which she reported helped with the heat and headache. At approximately 20 minutes she tried sitting up, but felt dizzy again about 2 minutes into sitting up. She lay down for approximately 10 more minutes, at which point she felt well enough to try sitting up again. After sitting on the floor for a few minutes she moved to a chair and still felt good. She remained seated in a chair for about 5 minutes and then stood up. She felt fine standing and was walked to her car by staff. She continued to report feeling fine, and left the clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,"Hx of diabetes, taking some medication for it, but unsure of name.",,Diabetes,,None,"['Dizziness', 'Dizziness postural', 'Feeling hot', 'Headache', 'Vomiting']",1,MODERNA,IM 923084,CT,50.0,F,Mild headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,Lamictal 100 mg Klonopin .5 mg,none,none,,none,['Headache'],2,PFIZER\BIONTECH,IM 923085,TX,45.0,F,"Red irritated, raised itchy and rashy (raised bumps) about a 3X2 spot arm is very sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PUB,"Proair HC, Symbalta, Xanax, Symbicort, Zanaflex, Celexa",no,LIP lung disease,,Dairy products,"['Erythema', 'Pain in extremity', 'Rash pruritic', 'Skin irritation']",1,MODERNA,IM 923086,IN,45.0,F,I?m not sure if it was related to the vaccine but on day after shot I had loss of appetite. Day 2 after shot I feel like I can?t get enough to eat. I?m not sure if this has any relation to that though,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,D3. Zinc. Green tea. B12. Fish oil. Vitamin c omeprazole,N/a,Heartburn,,Penicillin,"['Decreased appetite', 'Eating disorder']",1,PFIZER\BIONTECH,IM 923087,MO,30.0,F,"Redness and swelling at injection site. Soreness like a bruise. Redness started about the side of a nickel and progressed over the next 6-8 days to the size of a baseball. Localized swelling of that area was noticeable but not alarming. At two weeks the redness had completely resolved leaving just a nickel sized bruise. As of today 1/6/2021, everything has resolved. - Sought out no medical treatment for condition, just monitored at home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,WRK,"Zyrtec, mult-vitamin, vitamin D3",None,None,,None,"['Injection site erythema', 'Injection site swelling', 'Pain']",1,PFIZER\BIONTECH,IM 923088,IN,31.0,F,"Day after receiving vaccine, 101 fever, headache, chills, sore, tiredness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,UNK,Mirena,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 923089,AR,38.0,F,"Whole body aches, chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,None,None,Osteopenia,,None,"['Chills', 'Fatigue', 'Pain']",2,PFIZER\BIONTECH,IM 923090,NJ,25.0,F,Pt developed a swollen lymph node on left side of neck. She went to urgent care and lab tests are pending. Her Covid test was negative.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,PVT,Singulair,none,none,,"Gluten meal, oxycodone, sulfa antibiotics","['Lymphadenopathy', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 923091,VA,49.0,F,"Approximately 1 week after Moderna vaccine (first dose), I developed moderate rash with hives at the injection site (left upper arm). The area size of the rash/hives is approximately 4x6 inches. A slight lump is below the area. This has persisted for 1 day so far. I will monitor and follow-up with PCP if it persists. Please note: I developed a similar reaction within 48 hours of the injection (rash, no hives, more swelling, larger lump at the injection site), however, it resolved in approximately 12 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,Yaz birth control PRO45 probiotic Lysine supplement One 200 mg Advil,None,None,,Penicillin,"['Injection site mass', 'Injection site rash', 'Injection site swelling', 'Injection site urticaria']",UNK,MODERNA,IM 923092,PA,39.0,M,Developed strong metallic taste in mouth lasted over 24 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,WRK,,,,,,['Dysgeusia'],1,PFIZER\BIONTECH,IM 923093,FL,24.0,F,"chills, strong muscle pain, heart palpitation/ possible heart burn, headache, warmer temperature but not fever (99.5 F).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,Tylenol,,migraines,,dairy,"['Chills', 'Headache', 'Myalgia', 'Palpitations']",1,MODERNA,SYR 923094,,,U,"Dizziness, nerve pain, vomiting, injection site swelling and blistering, knot in injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Dizziness', 'Injection site nodule', 'Injection site swelling', 'Injection site vesicles', 'Neuralgia', 'Vomiting']",1,MODERNA,SYR 923095,AK,55.0,F,"MUSCLE PAIN ON RIGHT ARM, TOOK ALEVE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,VITAMIN C,,HYPER TENSION PRE DIABETES HIGH CHOLESTEROL GERD,,NONE,['Myalgia'],1,PFIZER\BIONTECH,IM 923096,CO,34.0,F,I had a low grade fever with chills. I had a blinding migraine all day that made me nauseous and fatigue. I am 11 weeks pregnant and my estimated delivery date is 07/28/2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,UNK,I take prenatal vitamins.,No,No,,No,"['Chills', 'Fatigue', 'Migraine', 'Nausea', 'Pyrexia']",1,MODERNA,IM 923097,PA,58.0,F,"Tachycardia, palpitations, elevated blood pressure, feeling faint, nausea, flushing",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Synthroid 0.1 mg, Singulair 10 mg, Protonix 40 mg, Zyrtec 25 mg, Vitamins C, Z, D3, evening primrose, biotin, turmeric.",none,"asthma, GERD","hive, 58, 11/20/2020, flu",Lisiniopril,"['Blood pressure increased', 'Dizziness', 'Electrocardiogram', 'Flushing', 'Nausea', 'Palpitations', 'Tachycardia', 'Vital signs measurement']",1,PFIZER\BIONTECH,IM 923098,NY,42.0,F,"axillary tenderness in left axilla--no palpable lymph node indurated, erythematous, warm, tender area on left arm at injection site that began at 5cm and expanded over 24 hours to 10 cm x 8 cm and associated with generalized body puritits, improved with 50 mg benadryl. no other skin changes, shortness of breath.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,WRK,none,none,none,,anaphylaxis to pine nuts and allergy to sutures,"['Axillary pain', 'Dyspnoea', 'Injection site pain', 'Injection site warmth', 'Pruritus', 'Rash erythematous']",1,MODERNA,IM 923099,AL,42.0,F,sore arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Tylenol 500mg,none,none,,none,['Pain in extremity'],1,MODERNA,IM 923100,MI,20.0,F,"She became light headed, nauseated,pupils dilated, pale and narrowed vision. Nursing staff assisted her to lay on floor with feet elevated. Vital signs with in normal limits. She did not lose conciousness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,None,None,None,,None,"['Dizziness', 'Mydriasis', 'Nausea', 'Pallor', 'Visual impairment']",1,MODERNA,IM 923101,AR,26.0,M,"Violent vomiting, body aches, headaches, temp of 99.7.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,"Wellbutrin, Cymbalta, trazodone, valacyclovir, Descovy for PrEP,",Diagnosed with covid 12/ 10/2020,None,,None,"['Body temperature increased', 'Headache', 'Pain', 'Vomiting']",1,MODERNA,IM 923102,GA,50.0,F,"""In my office all morning, started having shortness of breath around lunch time. I then made an appt for employee health and they suggested I leave and get tested""",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/31/2020,2.0,OTH,,,,,,['Dyspnoea'],1,MODERNA,IM 923103,VA,41.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,['Incorrect dose administered'],1,PFIZER\BIONTECH,IM 923104,VA,57.0,M,Vial diluted incorrectly. Patient received 42mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,['Incorrect dose administered'],1,PFIZER\BIONTECH,IM 923105,OR,31.0,F,"Ten minutes after Covid vaccine begin to feel ""itchy"" , lips tingling/itchy; dry heaving, chest pressure.E rythematous rash on face. Evidence of excoriation on neck and upper chest. No shortness of breath Rapid response team called and transported to ED. Received epinephrine, Benadryl, Pepcid, Zofran and Solu-Medrol. Discharged at 8:20 PM home. E Today she is experiencing: itching all over, lips tingling, legs and arms feel very heavy, weak. Will follow up with her healthcare provider MD @ Hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,,,,Pertussis vaccine in childhood,"Reglan, Morphine,Lamictal, Gabapentin, Pertussis vaccine","['Chest discomfort', 'Limb discomfort', 'Lip pruritus', 'Paraesthesia oral', 'Pruritus', 'Rash erythematous', 'Retching', 'Skin abrasion']",1,PFIZER\BIONTECH,IM 923106,OH,42.0,F,Right axillary discomfort 6 days after vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/05/2021,6.0,PVT,,,,,,['Axillary pain'],UNK,MODERNA,IM 923107,IN,41.0,F,"Allergic reaction to COVID vaccination. Vaccine given at 10:00. Allergic reaction around 10:30. Same reaction as shellfish allergy: mucous in throat, tightening of throat muscles, loss of voice. Patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Aphonia', 'Secretion discharge', 'Throat tightness']",1,MODERNA, 923108,VA,26.0,F,"fever 101.8 (resolved within 24 hours) lymphadenopathy (ongoing - submandibular, anterior/posterior/deep cervical) edema of soft tissues i throat on right side making it difficult to swallow SOB n/v/d",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,loestrin OCP Sertraline HCl 100mg qd Alprazolam 0.5mg PRN,none,"asthma, endometriosis",,"sulfa, dairy, peanuts, hazelnuts, soy, apples/peaches/pollen bearing fruit, wheat","['Diarrhoea', 'Dysphagia', 'Dyspnoea', 'Lymphadenopathy', 'Nausea', 'Pharyngeal oedema', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 923109,NJ,36.0,M,"Slight fever of 100.2, nausea (I did vomit), major body aches, migraine, uncontrollable shaking, soreness at the injection site and lack of sleep (due to the pain in my arm and body aching) all from 1/4 to 1/5 early morning. During the daytime hours of the 1/5, took Tylenol (1,000mg) every 5 hours (or so). Also had nausea (as well as had difficulty wanting to eat because I was nauseous), slight fever of 100, headache (no longer a migraine) and major body aches. Stayed home from work and relaxed on my couch (mostly). Today/currently, on 1/6 at 12:50pm, only symptoms I still have is soreness at injection site (not as sever-more of a discomfort) and slight body ache (not as sever). Last does of Tylenol was taken at 01:30am on 1/6.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PUB,none,none,chronic back pain,,none,"['Decreased appetite', 'Headache', 'Injection site pain', 'Insomnia', 'Migraine', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'Tremor', 'Vomiting']",1,MODERNA,SYR 923110,IN,57.0,M,"Had dizziness, strong spinning feeling in head, Chills while wrapped in blankets. Chills led into the evening of the 5th. Less prominent dizziness next day and chills had diminished mostly. Called in sick to work on the 6th due to dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Centrum Silver daily vitamin,none,none,,none,"['Chills', 'Dizziness', 'Malaise']",1,PFIZER\BIONTECH,SYR 923111,VA,53.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,['Incorrect dose administered'],1,PFIZER\BIONTECH,IM 923112,WI,41.0,F,"Moderna - Redness, warmth, pain, and swelling noticed at injection site the day after injection. Redness is about the area of 3 quarters side by side. Headache and fatigue also noted.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Lisinopril, Wellbutrin",None,Hypertenstion,,Sulfa,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 923113,CT,47.0,F,Significant soreness in arm where injection was administered. Onset within hours. Duration of approximately 36 hours. Treated with OTC pain reliever. Headache - mild. Onset within hours. Duration approximately 36 hours. Treated with OTC pain reliever.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,"Levothyroxin, multi-vitamin",None.,Hypothyroid,,None.,"['Headache', 'Injection site pain']",1,MODERNA,IM 923114,VA,57.0,M,Vial diluted incorrectly. Patient received 42mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,['Incorrect dose administered'],1,PFIZER\BIONTECH,IM 923115,IN,32.0,F,Hives and itching 2 Benadryl (25mg tablets) Hives were gone in the morning but still some slight itching,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Wellbutrin,,,,Sulfa medication,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 923116,MD,43.0,M,"pruritus at injection site on day 7 post vaccine raised, erythematous lesion (hive) and low grade fever developed on day 8 post vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,"Lisinopril, atorvastatin, sertraline, finasteride, Vitamin D",none,proteinuria,,None,"['Injection site pruritus', 'Pyrexia', 'Skin mass']",1,MODERNA,IM 923117,WI,31.0,F,Developed a moderate to severe headache several hours after the vaccine and moderate fatigue noted later in the evening.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,SEN,none,none,Chronic Bronchitis and Chronic Sinusitis,"Influenza vaccine, Diarrhea, Nausea vomiting and headache.",Antidepressant Medication,"['Fatigue', 'Headache']",1,MODERNA,IM 923119,VA,22.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,['Incorrect dose administered'],1,PFIZER\BIONTECH,IM 923120,PA,32.0,F,Swollen around left eye; facial swelling. Left after observational period of 15 minutes. returned to the clinic stating mild hedache. Symptoms had not worsened in last hour prior to re-presenting to the clinic. Obtained oral benadryl from outpatient pharmacy.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,WRK,Med list: Albuterol PRN maalox Clarinex 5 mg daily Mobic 15 mg tbalet daily Singular 10 mg 1 tablet at bedtime Junel 1/20 Sucralfate 10 mL,unknown,unknown,,Amoxicilin Augmentin Ciprofloxacin Gemifloxacin Cefprozil,"['Eye swelling', 'Headache', 'Swelling face']",1,MODERNA,IM 923121,IN,49.0,F,"Confusion, severe brain fog, nausea, diarrhea, severe headache, large red area around injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Fluoxetine, lamictal, losartan-hctz, Zyrtec, ritalin",None,"Hypertension, anxiety , depression, chronic pancreatitis",,"Effexor, imitrex, zomig, paxil, lexapro, morphine","['Confusional state', 'Diarrhoea', 'Feeling abnormal', 'Headache', 'Injection site erythema', 'Nausea']",UNK,MODERNA, 923122,NV,56.0,F,"Arm sore, abdominal swelling significant, gravel throat, tiredness, some wheezes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/04/2021,3.0,PUB,"Iron, multivitamin, fiber","Diabetes, asthma","Asthma, diabetes",,"Antibiotics, sulphur","['Abdominal distension', 'Fatigue', 'Pain in extremity', 'Throat irritation', 'Wheezing']",1,MODERNA,IM 923123,CT,19.0,F,swelling at the point of injection a week after date got.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"vitamin c supplement,",none,none,,none,"['Erythema', 'Induration', 'Injection site swelling', 'Lymphadenopathy']",1,MODERNA,IM 923124,CA,53.0,F,Fever Woozy Headache chills,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,,,,,,"['Chills', 'Dizziness', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 923125,TX,30.0,F,"I took the vaccine on Sunday and Monday morning my arm was sore and in the afternoon my arm was itching but not at the injection site, lower. then my eye started itching a little later. I got scared and went to the UC and they told me to take Benadryl. It was just for a day after I took the Benadryl the next day all was back to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/22/2020,2.0,PVT,Loestrin,no,no,,mushroom,"['Eye pruritus', 'Pain in extremity', 'Pruritus']",1,PFIZER\BIONTECH,SYR 923126,VA,26.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['Incorrect dose administered', 'No adverse event', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 923127,AR,44.0,F,Patient reported feeling itchy. Liquid Benadryl 25mg/10ml resolved the issue.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PHM,,,,,,['Pruritus'],1,MODERNA,IM 923128,WA,58.0,F,"Less than 24 hours after getting vaccine. developed, fever, chills, body aches. Highest fever was 103.1. Treated with 600 mg Ibuprofen. Left shoulder, bruised (purple and red). swelling, hot too touch. Very painful for last two days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Levothyroxine,none,Asthma,,"Shell fish, Tylox, Vicadin, Sulfa drugs","['Arthralgia', 'Chills', 'Contusion', 'Erythema', 'Pain', 'Pyrexia', 'Skin warm', 'Swelling']",1,MODERNA,IM 923129,WI,54.0,F,"20 minutes after receiving the vaccine, patient felt her lips swelling. She then noticed facial swelling and chest tightness. She then developed erythema to her chest area. She immediately was evaluated. Denies any SOB or difficulty breathing. Denies any itching or hives.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Neurontin Mobic Prinivil Wellbutrin Lexapro Topamax Trazodone,,HTN Depression with anxiety Chronic Headaches,,Bee Sulfa PCN,"['Chest discomfort', 'Erythema', 'Lip swelling', 'Swelling face']",1,PFIZER\BIONTECH,IM 923130,MN,37.0,M,significant HA and left sided face swelling around 18-24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Headache', 'Swelling face']",UNK,PFIZER\BIONTECH,SYR 923131,VA,26.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['Incorrect product formulation administered', 'No adverse event', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 923132,VA,33.0,F,Vial diluted incorrectly. Patient received 42mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['Incorrect dose administered', 'No adverse event', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 923133,VA,57.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['Incorrect product formulation administered', 'No adverse event', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 923134,NE,17.0,M,0.5mL Moderna COVID19 vaccine inadvertently given to individual under the age of 18. Vaccine administrator immediately notified patient and assessed for any adverse reactions (none noted). Provider also called to follow up with patient the following day and patient stated he was not experiencing any negative side effects.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PUB,,,,,,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,SYR 923135,VA,32.0,F,I experienced swelling under my skin above my left clavicle. I went to my PCP who ordered an ultrasound which revealed that my lymph nodes were inflamed. They suspect this was due to my vaccination as I otherwise do not seem to have any infections.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PUB,"Lexapro 15 mg daily, Hair Skin and Nails Gummies vitamins, Mirena IUD, Fluticasone Propionate Nasal Spray 50mcg 2 squirts in both nostrils daily",None,None,,"sulfa drugs, neomycin, tree nuts","['Lymphadenopathy', 'Soft tissue swelling', 'Ultrasound skull']",1,MODERNA,SYR 923136,MA,45.0,F,"On 7th day after receiving Moderna vaccine, spontaneously developed 3"" Discrete wheal surrounding injection site consistent with injection site reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,OTH,Vitamin D 2000 IU,none,none,,none,['Injection site urticaria'],1,MODERNA,IM 923137,FL,57.0,M,"1 WEEK AFTER I WAS GIVEN THE VACCINE I DEVELOPED A 4X4 CM RAISED, PAINFUL, WARM, AND RED AREA WHERE THE VACCINE WAS GIVEN.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/05/2021,4.0,WRK,NONE.,NONE,NONE,,NONE,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 923138,MT,38.0,F,"chills, body aches, fatigue, lethargy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"levothyroxine, vitamin D3, womens MVI, tumeric, omega-3 fish oil",no,hypothyroidism,,PCN,"['Chills', 'Fatigue', 'Lethargy', 'Pain']",1,MODERNA,IM 923139,CA,58.0,F,"Moderna COVID-19 Vaccine EUA Palpable patchy erythema with mild tenderness around injection site, onset 8 days after injection. As of the day of reporting, not significantly changed",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,01/04/2021,8.0,PVT,"Losartin, hydrochlorothiazide, alendronate, calcium citrate, multivitamin",none,"hypertension, low bone density, mild asthma, allergic rhinitis","Shingrix, fatigue and myalgias after 1st dose only",none known,"['Injection site erythema', 'Injection site pain']",1,MODERNA,IM 923140,IL,27.0,F,"High fever between 102 and 106.1, chills, nausea and vomiting, headaches, and body aches. Treated with Tylenol and ibuprofen, fluids, and cool rags. Symptoms began 1/4/21 around 8pm with a fever of 102 that increased through the night to 104 after vomiting.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Multi-vitamin, vitamin D",,,,Amoxicillin,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 923141,VA,31.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['Incorrect product formulation administered', 'No adverse event', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 923142,VA,42.0,F,Vial diluted incorrectly. Patient received 42mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['Incorrect dose administered', 'No adverse event', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 923143,GA,38.0,F,"Day 0 - vaccine received Day 1 - severe arm pain, mild chills and myalgias Day 2 - severe arm pain, mild chills, myalgias resolved, took Tylenol for arm pain Day 3 - pain improved, chills resolved Day 4 - all symptoms resolved Day 5 - felt fine Day 6 - right axillary pain and swelling Day 7 - worsening axillary pain, muscle aches Day 8 - same axillary pain, new erythema, induration, and itching at injection site, took Tylenol and ibuprofen Day 9 - all symptoms improving Day 10 - all symptoms continuing to improve",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/02/2021,5.0,WRK,Combined oral contraceptive pill,No,No,,None,"['Axillary pain', 'Chills', 'Erythema', 'Induration', 'Injection site pruritus', 'Myalgia', 'Oedema peripheral', 'Pain in extremity']",1,MODERNA,IM 923144,,51.0,F,"lightheadedness, spontaneous resolution",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,na,,,,na,['Dizziness'],UNK,PFIZER\BIONTECH, 923146,GA,62.0,F,"During vaccine administration, a small volume of vaccine (estimated volume 0.05mL) leaked between the syringe and needle. Likely due to needle being loose. No adverse effects noted",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Needle issue', 'No adverse event', 'Syringe issue', 'Underdose']",2,PFIZER\BIONTECH,IM 923166,VA,31.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['Incorrect dose administered', 'No adverse event', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 923167,WA,24.0,F,Significant headache and fever of 102 onset at 21:00.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,WRK,Keppra,COVID-19 12/15/2020,seizures,,reglan and fentanyl,"['Headache', 'Pyrexia']",1,MODERNA,IM 923170,GA,57.0,F,"Mild URI symptoms started approximately 4 hours post vaccination. By 6 p.m. (5 hours post vaccination), severe chills and fever of 105. Took 800 mg of Ibuprophen and 50 mg of Benadryl. Temp down to 102 by midnight. Fevers persisted, especially at night with extreme night sweats for 11 days often requiring a change of clothing up to 6 times through the night. No further respiratory symptoms past initial presentation. Night sweats have persisted but with less severity as of Day 15. Please note, I am also a healthcare provider and infectious disease epidemiologist, hence enterring my own VAERS.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,PVT,"Ambien, Trazodone, B-12, Iron, Diltazem, Prozac, HCTZ, D2, Calcium",conjunctivitis,"cardiac spasm, anemia, insomnia, arthritis",,green and red bell pepper; Neomycin ear drops (localized reaction). Not allergic to po Neomycin,"['Chills', 'Night sweats', 'Pyrexia', 'Sleep disorder', 'Upper respiratory tract infection']",UNK,PFIZER\BIONTECH,IM 923174,HI,47.0,F,"Modern a COVID-19 vaccine EUA Rash all over body from head to toe Started that night around 7 pm ( I got shot at 1:50 pm) Rash spreading to leg and then head It?s very itchy , No fever,",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,Loryna (north control) Fluoxetine Montelukast,None,None,,None,"['Rash', 'Rash pruritic']",UNK,MODERNA, 923176,IN,47.0,F,"Patient experienced skin redness and itching during the 15 minute post Pfizer COVID-19 vaccine injection observation period. Patient was given 25 mg diphenhydramine po, and the symptoms were resolved at 1100. Vitals time 1005 1055 B/P 134/78 130/84 P 65 73 RR 20 16 O2 Sat 98% 99%",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Erythema', 'Pruritus']",1,PFIZER\BIONTECH, 923177,AK,66.0,M,"MUSCLE PAIN ON THE RIGHT ARM, TOOK ADVIL",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,"VIT. C, D3, B12, ZINC",,HIGH CHOLESTEROL,,NONE,['Myalgia'],UNK,PFIZER\BIONTECH,IM 923178,TX,62.0,F,"Fever,body aches,chills,heada he body aches,light sensitivity,,sore throatpain at site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,"Vitamin D,HCTZ,",None,None,,Aspirin,"['Chills', 'Headache', 'Injection site pain', 'Oropharyngeal pain', 'Pain', 'Photophobia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 923179,MI,50.0,F,"Patient stated after 15 minutes of getting vaccination and stated she felt like she felt light headed, felt like head and tongue were swollen, but they didn't appear to be swollen. Speech was clear. Treated with 25mg benadryl po and monitored for 45 minutes and patient stated symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,allergy to sulfa and norco,"['Dizziness', 'Swelling']",1,PFIZER\BIONTECH,IM 923180,VA,46.0,U,Vial diluted incorrectly. Patient received 42mcg of Pfizer vaccine. No adverse reaction reported by patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['Incorrect dose administered', 'No adverse event', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 923182,OH,54.0,F,"CONGESTION, RUNNY NOSE, VATIGUE, ACHY MUSCLES",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/03/2021,8.0,WRK,,,NA/,,SHELL FISH,"['Fatigue', 'Myalgia', 'Respiratory tract congestion', 'Rhinorrhoea']",1,PFIZER\BIONTECH,IM 923183,AZ,39.0,M,"Panic attack 1 day after receiving vaccine, fast heartbeat, heartburn and digestive tract problems like diarrhea and excess gas that still haven't resolved, decreased appetite",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,None,None,None,,None,"['Decreased appetite', 'Diarrhoea', 'Dyspepsia', 'Flatulence', 'Heart rate increased', 'Panic attack']",1,PFIZER\BIONTECH,IM 923184,MT,38.0,F,"Chills, arthralgia, myalgia, fatigue, nausea presented rather rapidly in the early evening of 12/31/2020. A headache soon started. These symptoms continued until 1/2/2021 and were managed with max doses of IBU and APAP. On 1/2/2021 a small rash appeared on my right deltoid at the injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,PVT,escitalopram 10mg daily,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site rash', 'Myalgia', 'Nausea', 'SARS-CoV-2 test negative']",1,MODERNA,IM 923187,CA,61.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Beginning one week after receiving the injection, the site has a red spot about the size of a quarter and feels slightly irritated. It has been this way for approximately 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PUB,"calcium, magnesium, potassium, vitamin D, women's multi-vitamin, and flaxseed oil. All for general health.",none,osteoporosis - I receive a Prolia injection every 6 months. Next injection due January 2021.,,none known,"['Injection site erythema', 'Injection site irritation']",1,PFIZER\BIONTECH,SYR 923189,VA,67.0,F,Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient. On 1/4/2021 patient became COVID + after 2 COVID + contacts,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['COVID-19', 'Exposure to SARS-CoV-2', 'Incorrect product formulation administered', 'No adverse event', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 923192,CO,60.0,F,Severe arm pain at the site of the injection which started 24 hours after injection and persisting through today - day 9 postvaccine. The pain is lateral upper right arm and descends inferiorly toward the elbow. No redness or swelling at the site. I'm having great difficulty with sleep because of the pain. The pain is aggravated by motion. The pain is helped somewhat with ibuprofen 200 mg every 6-8 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,Prilosec 20 mg 1 tablet daily Vitamin D3 1000 IU daily,none,"Celiac disease, Osteoporosis",,none,"['Injection site pain', 'Pain', 'Sleep disorder']",1,MODERNA,IM 923194,MI,28.0,F,"Staff waited the full 30 minutes with no issues. At the 15 minute mark, her injection site was assessed by RN and was found to be without edema or erythema. At the 30 minute mark, the staff proceeded to her office. Upon arrival, she began to feel light-headed, and a co-worker noted that she had red areas on her chest and arms. The staff immediately returned to staff development for assessment, presenting with pronounced erythematous areas on her chest and upper arms, none noted on the stomach. The staff denied any problems breathing or swallowing. Throat appeared wnl upon inspection. Lung sounds were clear upon auscultation. Physician contacted, and 100ml Benadryl IM administered. Staff monitored until EMS arrived. 1343 T: 9.6 P: 132 R: 24 BP: 152/93 O2: 99% 1351 T: 97.6 P: 127 R: 21 BP: 148/96 O2: 99% 1400 T: 97.2 P: 121 R: 20 BP: 149/103 O2: 98% 1402 BP: 142/98 1417 T: 97.4 P: 157 R: 20 BP: 150/90 O2: 99%",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,none reported,none reported,none reported,,none reported,"['Dizziness', 'Erythema']",1,MODERNA,IM 923196,MS,40.0,F,"One hour after my shot I started with dizziness and I felt like I was going to pass out. I felt like my blood pressure was low, but it was really high 160/90. My heart rate was up in the 160's. This continued all day the first day and still continues randomly to today. Yesterday I had a random migraine , and today I am running a 100.2 temperature.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,WRK,Alprazolam as needed for panic attacks.,,,,,"['Body temperature increased', 'Dizziness', 'Hypertension', 'Migraine']",1,MODERNA,IM 923198,CA,43.0,F,"(R) lung region- Persistent dull pain, with sharp pain present when taking deep breaths, yawning, coughing, sneezing. Occasional mild chest tightness on (R) side upon exertion. No shortness of breath, no respiratory labor. No dizziness / headaches noted. No sided weakness, general fatigue noted. V/S= 115/68; 97.5; 68; 19; 8/10 (to affected areas mentioned); O2= 99% in room air.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,NACPro+ (Physician's Formula),None,Asthma like symptoms,,Beclomethasone Dipropionate; Codeine and Opiate Derivatives; Shellfish Derived products,"['Chest discomfort', 'Fatigue', 'Pain', 'Painful respiration', 'Pulmonary pain', 'SARS-CoV-2 test']",1,MODERNA,IM 923201,CA,56.0,F,"12/28/2020 I received injection to left arm, no pain notice after half hour . 12/29/2020 I c/o pain to injection site. No redness or swelling noted. OTC Tylenol 500mg taken for pain. 12/30/2020 Pain to left arm continued but it felt less painful. No signs of redness or swelling to area 12/31/2020 very minor pain to left arm. No signs of redness or swelling to injection site. 01/01/2021 to 01/03/2021 no pain to site, no swelling or redness noted. 01/04/2021 c/o itching to site, noted to have a round red spot with swelling to injection site. Area hot to touch. 01/05/2020 c/o pain to injection site, swelling and redness to injections site. Area hot to touch. 01/06/2021 continue with redness to injection site, swelling area feels hot to touch. Pain has decrease. Reported this to my hospitals health nurse",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,metoprolol succinate 50mg one tab at night Amlodipine besylate 5mg one tab in the am,none,Hypertension,,none,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity']",UNK,MODERNA,IM 923205,IL,32.0,F,"Headaches, nausea, chills, vertigo",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,"birth control pills, sertraline",,,,Chlorhexidine,"['Chills', 'Headache', 'Nausea', 'Vertigo']",1,PFIZER\BIONTECH,SYR 923208,FL,50.0,F,"Employee developed genralized rash, fast heartbeat, elevated blood pressure, and dizziness. She was given Epinephrine via pen 0.3mg to left outer thigh and 911 arrived to evaluate. Patient was taking to Hospital for evaluation and treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,OTH,"Zyrtec 10 mg daily, Metoprolol 25mg daily, and Meclizine 25mg at night","Hypertension, Arrythmia, Syncope",Diabetes Mellitus 2,,"Shellfish, Penicillin, Cat Hair","['Blood pressure increased', 'Dizziness', 'Heart rate increased', 'Rash']",1,MODERNA,IM 923211,SD,95.0,F,"Red, itchy left arm from elbow up to shoulder",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/04/2021,5.0,SEN,MVI Citalopram Synthroid Metamucil Tylenol ChlordiazePOXIDE,11/13/20 - upper respiratory infection 11/20/20- UTI 10/27/20 - Covid,"B91 SEQUELAE OF POLIOMYELITIS F41.1 GENERALIZED ANXIETY DISORDER F33.40 MAJOR DEPRESSIVE DISORDER, RECURRENT, IN REMISSION, UNSPECIFIED M41.9 SCOLIOSIS, UNSPECIFIED I10 ESSENTIAL (PRIMARY) HYPERTENSION M79.609 PAIN IN UNSPECIFIED LIMB Z86.12 PERSONAL HISTORY OF POLIOMYELITIS M20.10 HALLUX VALGUS (ACQUIRED), UNSPECIFIED FOOT R60.9 EDEMA, UNSPECIFIED R53.1 WEAKNESS I73.9 PERIPHERAL VASCULAR DISEASE, UNSPECIFIED E03.9 HYPOTHYROIDISM, UNSPECIFIED G81.91 HEMIPLEGIA, UNSPECIFIED AFFECTING RIGHT DOMINANT SIDE H35.30 UNSPECIFIED MACULAR DEGENERATION",,Keflex Zoloft,"['Cellulitis', 'Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 923213,IN,48.0,F,"Chills, shivering , body aches, nausea, fatigue, extreme pain and tenderness at the injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,WRK,"Lo-Estrin, Synthroid, Zoloft, Claritin, Calcium, Fiber",None,Thyroid cancer,,None,"['Chills', 'Fatigue', 'Injection site pain', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 923215,NY,58.0,M,Sore shoulder and 100 degree fever registered on a Braun thermoscan and fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,,None,None,,Shell fish,"['Arthralgia', 'Fatigue', 'Pyrexia']",1,MODERNA,SYR 923216,PR,30.0,F,"pain and inflammation of the right axillary nodule; pain and inflammation of the right axillary nodule; Pain in the right arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-year-old female received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration at the right arm on 28Dec2020 11:00 at a single dose for COVID-19 immunization. Medical history includes chronic migraine and sinusitis. The patient was not pregnant at the time of vaccination. Concomitant medications were amitriptyline and cetirizine hydrochloride (ZYRTEC). On 28Dec2020, the patient experienced pain in the right arm. On 29Dec2020 23:00, approximately 40 hours later the patient experienced pain and inflammation of the right axillary nodule. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Chronic migraine; Sinusitis,,,"['Lymph node pain', 'Lymphadenopathy', 'Vaccination site pain']",1,PFIZER\BIONTECH, 923222,GA,77.0,F,"are scabs; and minor itching / have been miserable with the itching; Not resting; still have purple areas on my legs, back and arm; still have red areas on my legs, back and arm; Lupus like rash; reports Rash / on her arms, legs, chest, and back; This case was reported by a consumer via call center representative and described the occurrence of rash lupus-like in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 10th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 18th November 2020, 8 days after receiving Shingrix, the patient experienced rash lupus-like (serious criteria GSK medically significant) and rash. On an unknown date, the patient experienced scab, pruritus, restlessness, skin discoloration and erythema. The patient was treated with dexamethasone and prednisone. On an unknown date, the outcome of the rash lupus-like and rash were recovering/resolving and the outcome of the scab, pruritus and restlessness were unknown and the outcome of the skin discoloration and erythema were not recovered/not resolved. The reporter considered the rash lupus-like, rash, scab, pruritus, restlessness and skin discoloration to be related to Shingrix. It was unknown if the reporter considered the erythema to be related to Shingrix. Additional details were reported as follows: She reported severe reaction to vaccine. She stated that the rash occurred on her arms, legs, chest, and back. The reporter reported Lupus like rash after Shingrix vaccine. The rash had lasted six weeks, but there were scabs and minor itching. The rash was improving with prednisone dose pack, dexamethasone and treatments. She had been cared by a dermatologist who confirmed the rash was from Shingrix via biopsy. She still had red, purple areas on her legs, back and arms which the doctor said were healing. She had been miserable with the itching and not resting. No more information was available. The reporter consented to follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,11/10/2020,11/18/2020,8.0,UNK,,,,,,"['Biopsy skin abnormal', 'Erythema', 'Feeling abnormal', 'Pruritus', 'Rash', 'Restlessness', 'Scab', 'Skin discolouration', 'Systemic lupus erythematosus rash']",1,GLAXOSMITHKLINE BIOLOGICALS,IM 923223,IL,31.0,F,"Fever, nausea, muscle pain, weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"vitamin A, zinc",,,,NKA,"['Asthenia', 'Myalgia', 'Nausea', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 923224,NJ,37.0,F,"25 minutes after vaccination patient developed red rash on left side of face and neck it then spread to right side of face and neck and chest and then forehead. She was evaluated by County EMS, given 50 mg Benedryl orally at 12:20pm by county nurse and transported via ambulance to the hospital at 12:25pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,Adderal birth control,no known,unknown,,Morphine and Reglan,"['Rash', 'Rash erythematous']",1,MODERNA,IM 923225,CA,42.0,F,"delayed urticarial at site of injection, resolved within 24 hours with 1 dose of fexofenadine 180mg",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,PVT,"hives around local injection site, resolved within 24 hours, 1 dose of fexofenadine taken",none,none,,none,['Injection site urticaria'],UNK,PFIZER\BIONTECH, 923226,TX,55.0,F,"1130 states that feeling of tingling both hands and denies other symptoms. VS BP 124/72, HR 79, Spo2 100 RA 1136 Denies tingling on both hands. 1140 VS BP 118/68, HR 63, Spo2 100 RA 1145 Checked out",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,Wellbutrin,unknown,unknown,,None,['Paraesthesia'],1,MODERNA,IM 923227,TN,40.0,U,"Patient reported fever, chills, body aches, and hives under arm and throughout body. Patient took over the counter Diphenhydramine HCl to treat. Fever gone as of 01/06/2021 and reported feeling better.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,Unknown.,Unknown.,Unknown.,,Unknown.,"['Chills', 'Pain', 'Pyrexia', 'Urticaria']",1,MODERNA,IM 923228,AL,62.0,F,"1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white noise in ears, fatigue lacinating pain ankles, knees ,wrist and finger joints; pain along nerves and vessels fingers with right fourth DIP ulnar side small vessel bleed hematoma 4 cm x 4cm swelling; NO trauma sedenatry Saw Urgent care 1/4/21 -with negative covid 19, strep and flu tests said was repsonse to vaccine Saw primary 1/5/21 Dr hopsital, said probably had covid before and was repsonse to vaccine. 1/6/21; all fingers still swollen no pain most other symptoms improving but TIRED",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PVT,valsartan 80 mg bid venlaflaxine 75 mg hs omperazole 20 mg am Vit D 5000 u 2 x a week Citracal max 2 tablets a day Centrum silver one a day Calcium gummies 750 mg 3-4 x a week if no other Ca++ source that day Magnesium citrate 250 mg 3-4,mild runny noise ;clear.,"Sinnusitis. Reflux disease, HTN, anxiety, pre diabetic BMI:30 Mild occasional knee and wrist aches",flu like symptoms after flu vaccine; did not occur this year,"topical insensitivites to make up oral insensitivites to raw pineapple, sometimes melons prolonged latex work gloves exposure causes itiching and swelling","['Arthralgia', 'Chills', 'Fatigue', 'Influenza virus test negative', 'Nausea', 'Neuralgia', 'Ocular hyperaemia', 'Pain in extremity', 'Peripheral swelling', 'Pharyngeal swelling', 'Pyrexia', 'SARS-CoV-2 test negative', 'Streptococcus test negative', 'Tinnitus', 'Vascular injury', 'Vision blurred']",1,PFIZER\BIONTECH,IM 923229,FL,35.0,F,"This is a spontaneous report from a contactable other healthcare professional, the patient. A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK5730, via an unspecified route of administration on 29Dec2020 at 13:30 (at the age of 34 years old) as a single dose in the right arm. Medical history included fibromyalgia, anxiety disorder, and allergy to amoxicillin from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included omeprazole 40mg and duloxetine 120 mg, both for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 29Dec2020 at 18:30, the patient experienced severe body aches, chills, minor headache, and swollen lymph nodes on neck. On 30Dec2020, the patient experienced productive cough. The patient did not receive treatment for the events. The clinical outcome of body aches, chills, minor headache, swollen lymph nodes on neck, and productive cough was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Diabetes (other medical history Diabetes),,,"['Lymphadenopathy', 'Pharyngeal disorder', 'Pharyngeal swelling']",1,PFIZER\BIONTECH,OT 923230,PA,50.0,F,"She presents to the emergency department after receiving a COVID-19 vaccination today and having signs and symptoms of anaphylaxis. She described having sensation of swelling in her throat as well as cutaneous rash. On presentation she is also coughing very frequently. She is treated with IM epi, IV Benadryl and IV Solu-Medrol. This rapidly improved her overall symptoms. Reported per: Moderna COVID - 19 Vaccine EUA requirements",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,Seasonal allergies,,"Latex, Clobetasol","['Anaphylactic reaction', 'Cough', 'Pharyngeal swelling', 'Rash']",1,MODERNA,IM 923231,DE,56.0,F,Petechial rash which developed 3 days post vaccination on bilateral lower extremities. No respiratory distress. No changes in medications or diet habits. Feels weel,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,WRK,REMICADE Arava HCTZ/ Losartan Amlodipine,None reported,Rheumatoid Arthritis,,NKDA,"['Herpes simplex test negative', 'Petechiae', 'Rash', 'Varicella virus test negative']",1,PFIZER\BIONTECH,IM 923232,CA,57.0,F,"I received the vaccine at 11: am on 01/04 Started feeling the joint/body aches in the afternoon around 4:oo pm and the soreness in my arm. then at night around 7 fever started at 102.0 took 1000mg Tylenol and took Advil alternate. The following day I thought i was okay, took shower, and went to work at 7:00 am but the temp screener sent me home of a 101.1 fever. at the same day throbbing headache and terrible body ache again makes me not going to sleep feeling the terrible pain body aches until today. I started taking Excedrin for the throbbing headache that helps a bit.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,none,none,none,,no known drug allergies,"['Arthralgia', 'Headache', 'Impaired work ability', 'Pain', 'Pain in extremity', 'Pyrexia', 'Sleep disorder']",1,MODERNA,IM 923233,MS,51.0,F,"Face Flush, Chills to the bone and body felt like it was on fire while I was having chills but had no fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/05/2021,4.0,PVT,"Trintellix, Buspar, Crestor, Estradiol, Vit. D, Vit. C",,,,,"['Chills', 'Feeling hot', 'Flushing']",UNK,MODERNA, 923234,,,F,"Allergies; left arm was sore; Stuffy nose; loss of smell/ smell not working; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, lot number: either EH9899 or CH9899), via an unspecified route of administration at the left arm on an unspecified date at a single dose for an COVID-19 immunization. The patient has no medical history. There were no concomitant medications. On 22Dec2020, the patient experienced loss of smell. The patient reported having like what appears to be allergies, stuffy nose and her smell not working. The left arm was sore until the 19th and four days after the injection and just soon after getting it she had stuffy nose. The arm was not really sore, but the patient was still having stuffy nose and the loss of smell. The outcome of the events loss of smell/ smell not working and stuffy nose was not recovered; allergies was unknown; left arm was sore was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/22/2020,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Allergy to vaccine', 'Anosmia', 'Nasal congestion', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 923235,TX,57.0,F,Moderna COVID?19 Vaccine EUA?,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PHM,None,None,None,,None,['Unevaluable event'],UNK,MODERNA,IM 923236,MO,,F,"4 different auto immune diseases; Caller states she had an allergic reaction to pneumonia shot 10 years ago.; This is a spontaneous report from a contactable consumer (patient). An adult female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (manufacturer reported as Pfizer), lot number and expiration date not reported, via an unspecified route of administration on an unspecified date (reported as 10 years ago) at single dose for immunization. The patient medical history was not reported. The patient stated that she was taking 26 different medicines (unspecified). The patient stated she had an allergic reaction to pneumonia shot 10 years ago and has 4 different autoimmune diseases and has a lot of allergies. She was wondering, and trying to find out about the COVID 19 if she should get the thing or not but she can't find out what was there in the Pneumonia Vaccine to see if she should get the COVID 19 Vaccine or if she should wait as both are manufactured by Pfizer. The patient stated that she was getting ready to have some more blood work, about every three months she has blood work done because she has auto immune diseases. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Unevaluable event'],UNK,UNKNOWN MANUFACTURER, 923237,CA,58.0,F,SHINGLES,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/20/2020,,PVT,NONE,NONE,PSORIATIC ARTHRITIS,,PCN,['Herpes zoster'],UNK,PFIZER\BIONTECH,IM 923238,IA,49.0,F,"Sensation of lightheadedness, difficulty focusing , nausea and shortness of breath",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Metformin, Escitalopram, Buproprion, Vitamin D, Rosuvastatin, Adderall",No,"CAD, Anxiety/Depression",,No,"['Disturbance in attention', 'Dizziness', 'Dyspnoea', 'Nausea']",UNK,MODERNA, 923239,IN,59.0,F,Fever between 99.6-100 degrees fahrenheit for 24 hours. Weakness and mild nausea.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"Estrogen patch, vitamin D, Calcium, Niacin",None,Degenerative disc disease Menopause induced by hysterectomy,,"Sulfa medication, dairy products","['Asthenia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 923240,ID,41.0,F,"Fever, Chills, and fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Chills', 'Fatigue', 'Pyrexia']",1,MODERNA,IM 923241,IN,46.0,F,Extreme fatigue and nausea.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,Trazadone 25mg q hs Lisinopril 10 mg qd Procardia 30mg qd,None,Psoriasis sleep apnea on cpap,,Nka,"['Fatigue', 'Nausea']",1,PFIZER\BIONTECH,IM 923242,NY,49.0,F,lightheadedness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,nka,['Dizziness'],1,MODERNA,IM 923243,FL,76.0,F,"On the sixth day after the vaccination at the site of the vaccination on the left upper arm I experienced slight swelling, redness, and itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/05/2021,6.0,OTH,"Carbidopa/Levodopa, amlodipine besylate, Synthroid, Vitamin B12, Vitamin D3",None,"Parkinson's Disease, hypothyroid, hypertension",,"Lexapro, Wellbutrin, Cipro","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 923244,,,U,"tested positive for the Covid 19; tested positive for the Covid 19; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 18Dec2020 as the first single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for the COVID 19 on 27Dec2020. The patient underwent lab tests and procedures which included a test for Covid 19 virus, which was positive on 27Dec2020. The outcome of tested positive for the COVID 19 was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/27/2020,9.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 923245,TX,45.0,M,2nd dose of vaccine given 2 early. 1st dose given on 12/23/2020 and 2nd dose given 13 days later.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Inappropriate schedule of product administration', 'No adverse event']",2,PFIZER\BIONTECH,IM 923246,LA,49.0,F,"coughing; Itching; chest tightening; large whelps all over body, face, eyes; high blood pressure and heart rate noted; high blood pressure and heart rate noted; 18 hrs after vaccine mild rash on back and arms and mild sob; 18 hrs after vaccine mild rash on back and arms and mild sob; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9231), via an unspecified route of administration in the right arm on 23Dec2020 at 19:30 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, kidney stones, and gastrooesophageal reflux disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethynylestradiol/norgestrel (OGESTREL-28), cetirizine hydrochloride (ZYRTEC), and cefdinir (OMNICEF). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took nicotinic acid (NIACIN) on unknown dates for an unknown indication and experienced drug allergy in the form of mild flushing. On 24Dec2020 at 13:30, 18 hours after the vaccine, the patient experienced mild rash on back and arms and mild shortness of breath (SOB). On 25Dec2020, the next day, the patient had a severe rash with large whelps all over body, face, eyes. She had extreme SOB, chest tightening, coughing and itching. The patient went to the hospital emergency room and high blood pressure and heart rate were noted. On 25Dec2020, the patient had a nasal swab done for COVID and it was negative. The patient was treated for the events with IV methyprednisolone (MANUFACTURER UNKNOWN), IV famotidine (MANUFACTURER UNKNOWN) and hydroxyzine pamoate (VISTARIL). The clinical outcomes of the rash, SOB, large whelps, chest tightening, couching, itching, high blood pressure, and high heart rate, were recovered in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,OGESTREL-28; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; OMNICEF [CEFDINIR],,Medical History/Concurrent Conditions: Asthma; GERD; Kidney stones,,,"['Blood pressure measurement', 'COVID-19', 'Chest discomfort', 'Cough', 'Dyspnoea', 'Heart rate', 'Heart rate increased', 'Hypertension', 'Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH, 923247,CA,41.0,F,1/4/21-Headache with aura started around noon progressing into the evening with extreme muscle and joint pain. Mostly from the calf to both feet with swelling. Fever started next day 1/5/21 till current 1/6/21. Highest temp 102 degrees. Painful to walk or stand. Nausea- no vomiting. Swollen shoulder at the injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,Carvedilol 25mg,Migraine in December 2020,"DMtype 2, hx of heart failure, asthma",,Eggs-edible,"['Arthralgia', 'Aura', 'Headache', 'Injection site swelling', 'Myalgia', 'Nausea', 'Pain', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 923248,DE,33.0,M,"Nausea; Ache; Chills; Fever; chest tightness congestion; woke up sweating; cough; fatigue; This is a spontaneous report from a Pfizer-sponsored program a contactable consumer. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK5730), via an unspecified route of administration on 23Dec2020 at 10:00 as single dose for COVID-19 immunization. There was no medical history and no concomitant medications. The patient experienced ache on 25Dec2020, at 08:30 with outcome of not recovered; chills on 25Dec2020, at 08:30 with outcome of not recovered; fever on 25Dec2020 with outcome of recovering; chest tightness congestion on 25Dec2020 with outcome of not recovered; nausea on 27Dec2020 with outcome of recovering; woke up sweating on 25Dec2020 with outcome of not recovered; cough on Dec2020 with outcome of unknown; fatigue on Dec2020 with outcome of unknown. Therapeutic measures were taken as a result of ache, chills, fever, chest tightness congestion, nausea, woke up sweating, cough and fatigue. Details were as follows: Patient received the vaccine. Then he noticed on 25Dec2020 at 0830AM body aches and chills. Then later a chest tightness. Then the next day 26Dec2020 it got worse and he noticed fever. He didn't take his actual temperature. He did notice in the middle of the night he woke up sweating. He has not had a COVID test. He has not been treated, but has taken acetaminophen (TYLENOL) and ibuprofen and nasal spray. He also mentioned that he experienced chest congestion and one day of nausea. The patient added that the aches were the worst in the night and at first waking up in the morning. With regard to fever, it got a little better but it seemed to depend on temperature, first he was cold and then sweating. The fever seemed like it improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/01/2020,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chest discomfort', 'Chills', 'Cough', 'Fatigue', 'Hyperhidrosis', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 923249,,62.0,F,"Intense fatigue, intense muscle and joint pain. No treatment given except for bed rest. Symptoms mostly gone by the next day (they lasted around 12-20) hours).",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Arthralgia', 'Fatigue', 'Myalgia']",1,MODERNA,IM 923250,CA,56.0,F,"Severe left side knee and shoulder pain; Could barely walk; could not lift left arm above 90 degrees; The arm pain was not your typical injection site pain from a flu shot; This is a spontaneous report from contactable healthcare professional, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685), intramuscular in the left arm on 25Dec2020 at 09:00 as a single dose for COVID-19 immunization. Medical history included asthma, hypertension, arthritis, and sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D) and losartan (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Dec2020 at 21:00, the patient experienced severe left side knee and shoulder pain, could barely walk, and could not lift left arm above 90 degrees. The patient stated that the arm pain was not your typical injection site pain from a flu shot. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for the events. The clinical outcomes of severe left side knee and shoulder pain, could barely walk, could not lift left arm above 90 degrees, and arm pain was not your typical injection site pain of flu shot, were recovering. The events were all reported as non-serious. However, it was also reported that the duration of hospitalization was 1 (not further specified).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/25/2020,12/25/2020,0.0,PVT,VITAMIN D [COLECALCIFEROL];,,Medical History/Concurrent Conditions: Arthritis; Asthma; Hypertension; Sulfonamide allergy,,,"['Arthralgia', 'Gait disturbance', 'Vaccination site movement impairment', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 923251,CA,49.0,F,periorbital swelling ;swelling of lips tightening of lips ; BP elevated remained elevated more than 15mins Transported to Emergency Room for evaluation Received Benedryl 50 mg PO,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,Calcium MVI Claritin Omega 3 MVI Glucosamine,,,,? Aspirin Hives ? Contrast Dye Itching ? Ibuprofen Rash ? Ketorolac Tromethamine Hives ? Pcn [Penicillins] Rash,"['Blood pressure increased', 'Lip swelling', 'Periorbital swelling']",1,PFIZER\BIONTECH,IM 923252,VA,24.0,F,"Pain at injection site; Chills; Fever; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730 via an unspecified route of administration, in the right arm, from 28Dec2020 07:30 at a single dose, for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included estradiol (ESTROGEN) cream. On 28Dec2020 22:45, the patient experienced pain at injection site, chills and fever. The outcome of events was reported as recovering. No follow up attempts are needed. No further information is expected. Information on the batch/lot number has been obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,ESTROGEN,,,,,"['Chills', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 923253,OH,54.0,F,Swelling and pain under left arm in the axilla anterior area and left ear drum.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,PVT,Tylenol xtra strenght Flexaril Aleve Allegra multi vitamin benadryl cold and flu,Sinus infection diagnosed 12-5-20,Back pain from a work injury and chronic sinus infections,,PCN- white injection causes vomiting myacins-rash sulfa (causes facial swelling bactrim),"['Axillary pain', 'Ear pain', 'Ear swelling', 'Oedema peripheral']",1,MODERNA,IM 923254,MI,56.0,F,"Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; This is a spontaneous report from a contactable nurse. A 56-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKS730), intramuscularly on 20Dec2020 08:45AM at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Patient was diagnosed with COVID-19 prior to vaccination. Known allergies included Penicillin. Concomitant medication included levothyroxine, pravastatin, buspirone, zinc, ascorbic acid (VITAMIN C), tocopherol (VITAMIN E), vitamin d3, vitamin b complex (B COMPLEX), calcium citrate, chondroitin sulfate, glucosamine sulfate, methylsulfonylmethane (GLUCOSAMINE CHONDROITIN & MSM). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash on 20Dec2020. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The patient underwent Covid test type post vaccination - Nasal Swab: Negative on 23Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,PVT,; ; ; ; VITAMIN C; VITAMIN E; VITAMIN D3; B COMPLEX; ; GLUCOSAMINE CHONDROITIN & MSM,,Medical History/Concurrent Conditions: COVID-19; Penicillin allergy,,,"['Arthralgia', 'Body temperature', 'Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Rash', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 923255,,,F,"drooping on one side of the face/ eye hurts to open and hurts to close it; Her eyes are droopy; ""my eye is hurting so bad"", it hurts to open and hurts to close it/pain in the eyes; Face is tender to the touch and hurts on that one side; Swelling of her left side of her face that hasn't gone down/swelling and drooping on one side of the face; This is a spontaneous report from a contactable nurse (patient). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller asking if pain in the eyes and swelling and drooping on one side of the face a side effect of the vaccine. Patient received the Covid vaccine on 23Dec2020 and noticed the next day (24Dec2020) swelling of her left side of her face that hasn't gone down. Her face is tender to the touch and hurts on that one side. Her eyes are droopy, ""my eye is hurting so bad"", it hurts to open and hurts to close it. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset eye hurts to open and hurts to close/ eyes droopy cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/24/2020,1.0,UNK,,,,,,"['Eye pain', 'Eyelid ptosis', 'Facial pain', 'Pain', 'Swelling face', 'Tenderness']",UNK,PFIZER\BIONTECH, 923256,TX,26.0,M,"He has a 100.0 fever; Cough; Little bit of congestion in his chest; Body ache; Sore shoulder; Joint pain; Muscle pain; This is a spontaneous report from a contactable consumer. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), intramuscular on 21Dec2020 as single dose for covid-19 immunization. There was no medical history and no concomitant medications. The patient experienced body ache on 27Dec2020 with outcome of unknown; sore shoulder on 27Dec2020 with outcome of unknown; joint pain on 27Dec2020 with outcome of unknown; muscle pain on 27Dec2020 with outcome of unknown; he has a 100.0 fever on 28Dec2020 with outcome of unknown; cough on 28Dec2020 with outcome of unknown; little bit of congestion in his chest on 28Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included fever at 98.9 on 27Dec2020, and 100.0 on 28Dec2020, weight: 315 on an unspecified date. Details were as follows: patient has been experiencing side effects. Per the reporter (wife to patient), he got a little under the weather, body ached kind of like sore shoulder, like joint pain, muscle pain. He did not have a headache. First he had a fever at 98.9, it was okay but this morning as he woke up, it was 100.0 fever. When he woke up, he felt better because he rested, but he woke up with a cough and a little bit of congestion in his chest. Therapeutic measures were taken as a result of the events, and included acetaminophen (TYLENOL). The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/27/2020,6.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Body temperature', 'Cough', 'Myalgia', 'Pyrexia', 'Respiratory tract congestion', 'Weight']",UNK,PFIZER\BIONTECH,OT 923257,IN,22.0,F,"received the COVID-19 vaccine on 19Dec2020 and then contracted COVID-19/positive COVID-19 test after receiving COVID-19 vaccine; received the COVID-19 vaccine on 19Dec2020 and then contracted COVID-19/positive COVID-19 test after receiving COVID-19 vaccine; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect via a contactable consumer. A 22-year-old female patient receive bnt162b2 (BNT162B2, also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration in left arm/deltoid on 19Dec2020 at 0.3 mL, single for Covid-19 immunisation (as protection). Medical history included ulcerative colitis. The patient's concomitant medications were not reported. On 28Dec2020, the patient was positive for COVID-19 test after receiving COVID-19 vaccine. She informed she contracted COVID-19 due to an exposure from a co-worker. The outcome of events was not recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/28/2020,9.0,UNK,,,Medical History/Concurrent Conditions: Ulcerative colitis,,,"['Occupational exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 923258,CA,45.0,F,"next day with headache, nausea, dizziness, tachycardia up to 170 for about 30 minutes. symptoms started the morning after the vaccine about 24 hours later and then resolved within that next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,PVT,,,"migraine, musculoskeletal strains, history of palpitations",,nkda,"['Dizziness', 'Headache', 'Nausea', 'Tachycardia']",UNK,PFIZER\BIONTECH, 923259,CA,37.0,F,"mild asthma attack; moderate dyspnea; chest pressure; a 4-5 cm area of induration; mild erythema in her left deltoid area; This is a spontaneous report from a contactable physician. A non-pregnant 37-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: Unknown), intramuscularly in the left arm on 19Dec2020 at 37-years-old at a SINGLE DOSE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included intermittent asthma from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced the following events and outcomes: mild asthma attack on 21Dec2020 with outcome of recovering, moderate dyspnea on 21Dec2020 with outcome of recovering, chest pressure on 21Dec2020 with outcome of recovering, a 4-5 cm area of induration in Dec2020 with outcome of unknown, mild erythema in her left deltoid area in Dec2020 with outcome of unknown. The patient had intermittent asthma with no attacks in the past six years. Two days after the vaccination, she had a mild asthma attack when she was walking up stairs. For the past two days, she has had multiple asthma attacks, with moderate dyspnea and chest pressure present for most of the day. The patient's symptoms have been improving with her as needed (PRN) salbutamol (ALBUTEROL) inhaler. The physician saw the patient in a telemedicine visit and found her to have an asthma exacerbation; therefore, prednisone was prescribed. The patient had no symptoms of viral infection and reported testing negative for COVID-19 after the onset of her asthma symptoms. The physician suspected her asthma exacerbation to have been caused by the vaccine because she had been symptom-free in recent years and she has not had a new exposure other than the vaccine. In addition to her respiratory symptoms, the patient had a 4-5 cm area of induration and mild erythema in her left deltoid area; this appeared about 1 week after she received the vaccine. Therapeutic measures were taken as a result of mild asthma attack, moderate dyspnea, chest pressure. The patient, since the vaccination, had been tested for COVID-19. Prior to the vaccination, the patient was not diagnosed with COVID-19. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: Asthma,,,"['Asthma', 'Chest discomfort', 'Dyspnoea', 'SARS-CoV-2 antibody test', 'Vaccination site erythema', 'Vaccination site induration']",1,PFIZER\BIONTECH,OT 923261,TX,46.0,F,"Dizziness,Weakness, very low and then High blood pressure.(Uncontrollably)",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/04/2021,1.0,OTH,"Metformin500mg twice daily,400mg ibuprofen once,Metoprolol 25mg er once daily,Montelukast 10mg one daily,Breo fluticasone,one inhalation daily,Albuterol sulfate inhalation aerosol one puff every 4 hours or as needed,multivatimins.","None,only The preexistents Asthma,Diabetes and High blood pressure.","Asthma,Diabetes and High blood pressure.",,"Aspirin,grass,dust,polen,pet hair.","['Asthenia', 'Dizziness', 'Hypertension', 'Hypotension']",1,MODERNA,SYR 923262,PA,44.0,F,"After left the clinic - 35 minutes post injection felt lightheaded, warm and some chest pressure. Clinic had ended. Sent to the ED for evaluation. EKG and Chest xray done - within normal limits. Discharged from the ED with a discharge note of likely vasovagal response",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,WRK,no,unknown,unknown,,darvocet vicodin latex percocet venofer,"['Chest X-ray normal', 'Chest discomfort', 'Dizziness', 'Electrocardiogram normal', 'Feeling hot', 'Presyncope']",1,MODERNA,IM 923263,LA,39.0,F,"Fever of 100 degrees for one week; This is a spontaneous report from contactable healthcare professional, the patient. A 39-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 16Dec2020 at 09:00 (reported as at the age of 39-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Dec2020, the patient experienced fever of 100 degrees Fahrenheit for one week. The patient went to the doctor for the event but was not given any treatment. The patient was tested twice for COVID-19 during the week of the fever in Dec2020 and both time the results were negative. The clinical outcome of fever of 100 degrees Fahrenheit for one week was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/22/2020,6.0,PVT,,,,,,"['Body temperature', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 923264,CA,43.0,M,Sudden fatigue lasting 3 hours then gradually went away.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,SEN,Balsalazide Atorvastatin,,Ulcerative colitis Hyperlipidemia,,Penicillin,"['Fatigue', 'Immediate post-injection reaction']",1,PFIZER\BIONTECH,IM 923265,OK,26.0,F,"on/off mild headache; extreme fatigue; swollen, very tender pea size lymph node by collarbone nearest to the injection site; This is a spontaneous report from a contactable nurse (patient herself). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) via an unspecified route of administration (arm left), on 18Dec2020 at 10:45, at a single dose, for COVID-19 immunization. Patient is not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included attention deficit hyperactivity disorder (ADHD), anxiety, chronic back pain, and allergies to penicillin. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), baclofen, oxymetazoline hydrochloride (CLARITIN ALLERGIC), and sertraline hydrochloride (ZOLOFT). On 19Dec2020, 24hrs post vaccination, the patient had a swollen, very tender pea size lymph node by collarbone nearest to the injection site, and an on/off mild headache. 48hrs post vaccination, patient had extreme fatigue and on/off headache, still had swollen lymph nodes. The patient did not receive treatment for the events. Outcome of the event swollen lymph nodes was not recovered, while for the other events was unknown. Since the vaccination, has the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/19/2020,1.0,PVT,JUNEL FE; ADDERALL; ; CLARITIN ALLERGIC; ZOLOFT,,Medical History/Concurrent Conditions: ADHD; Anxiety; Chronic back pain; Penicillin allergy,,,"['Fatigue', 'Headache', 'Lymphadenopathy']",1,PFIZER\BIONTECH, 923266,FL,,M,"received his first dose of the vaccine and tested positive for Covid yesterday; received his first dose of the vaccine and tested positive for Covid yesterday; This is a spontaneous report from a contactable healthcare professional. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received his first dose of the vaccine on 17Dec2020 and tested positive for Covid yesterday (28Dec2020). He is scheduled to have his second dose in January. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role BNT162B2 vaccine cannot be completely excluded for event ""tested positive for COVID"".",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/28/2020,11.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 923268,DE,59.0,F,"headache; After she got the vaccine, she was exposed to someone who had Covid; This is a spontaneous report via a Pfizer Sponsored Program, Pfizer First Connect from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on the right arm 21Dec2020 at single dose for Covid prevention. Medical history included blood pressure and can't see to read without her glasses. Concomitant medication included amlodipine. The patient stated, ""she got the Covid vaccine on 21Dec2020 and had a headache for 1-2 days. After she got the vaccine, she was exposed to someone who had Covid, and wants to know if she can still get the second dose. She has had no symptoms after being exposed (Dec2020) but is about to be tested just in case she gets the virus. Her co-worker was positive and they were all in the breakroom without a mask. A couple other nurses are also concerned and don't know whether to get the second shot. They test at the hospital every Wednesday and wanted to know if she still can be tested before she gets the second shot. She had slight headaches on the 22nd, so she took some EXCEDRIN and it went away"". The outcome of headache was recovered on 22Dec2020 and other event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518688 same reporter/drug, similar event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/01/2020,,PVT,,,Medical History/Concurrent Conditions: Blood pressure abnormal; Eyeglasses wearer,,,"['Exposure to SARS-CoV-2', 'Headache']",1,PFIZER\BIONTECH,OT 923269,,,M,"he was flushed; light headed; tingling around mouth; 3-4 minutes after my blood pressure was high; heart rate was 120 or so; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received the first dose of BNT162B2 (lot number unknonwn), via an unspecified route of administration, in Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he received the first dose of the vaccine 11 days ago in Dec2020 and had a reaction. He stated probably 3 minutes after when he was getting ready to leave the area he was flushed and light headed and tingling around mouth. The staff in the area sat him down and 3-4 minutes after his blood pressure was high and heart rate was 120 or so. Those symptoms lasted about 10 minutes and went away on their own and he did not get epi pen or Benadryl. The patient's vital signs were normal after an hour or so and there was no intervention at any point and have had no issues subsequently. He stated that they said it wasn't technically an anaphylactic reaction but that it is hard to put a name to this description. The outcome of the events was recovered in Dec2020. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Blood pressure measurement', 'Dizziness', 'Flushing', 'Heart rate', 'Heart rate increased', 'Hypertension', 'Paraesthesia oral', 'Vital signs measurement']",1,PFIZER\BIONTECH, 923270,IN,32.0,F,"Nausea and chills starting about 12 hours post injection, lasting a few hours. Fatigue and muscle fatigue the day after injection lasting into the second day after injection (today).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Duloxetine HCL DR 30 MG CAP,,,,,"['Chills', 'Fatigue', 'Muscle fatigue', 'Nausea']",1,PFIZER\BIONTECH,SYR 923271,,,F,"tested positive for COVID after the first dose; tested positive for COVID after the first dose; This is a spontaneous report from a contactable Pharmacist reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via an unspecified route of administration on 22Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient informed that she had the COVID-19 vaccine exactly a week ago (22Dec2020). However, she was tested positive for COVID (Dec2020) after the first dose. The outcome of the events tested positive for COVID after the first dose was unknown. The patient asked if she can take the second dose. Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/01/2020,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 923272,TX,,M,"headaches; This is a spontaneous report from a non-contactable nurse practitioner. An adult male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 14Dec2020 at 17:00 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. On 28Dec2020, the patient experienced headaches (non-serious). The clinical course was reported as follows: The patient was a nurse practitioner who received the Pfizer vaccine. The patient reported getting headaches 15 days (as reported) after the first shot. The patient had no idea if the event was related to the vaccination, but he had no history of headaches. The patient took 600mg of ibuprofen (ADVIL) ""to try to get the HA."" The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was unknown prior to vaccination, if the patient was diagnosed with COVID-19. It was unknown, since the vaccination, if the patient had been tested for COVID-19. Therapeutic measures were taken as a result of headaches. The clinical outcome of the event was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/14/2020,12/28/2020,14.0,PVT,,,,,,['Headache'],1,PFIZER\BIONTECH, 923273,IN,34.0,F,ADR to Moderna Vaccine History of allergic reactions. Took diphenhydramine 25 mg prior to injection. Facial and finger swelling along with redness noted 40 minutes later. Took second dose of diphenhydramine. Was decreasing when patient returned to clinic. Has allergy treatment plan form allergist and felt comfortable going home. Developed metal taste soon after vaccine. Several hours later developed heahache and chills a couple hours later.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,PVT,,,,,,"['Chills', 'Dysgeusia', 'Erythema', 'Headache', 'Peripheral swelling', 'Swelling face']",1,MODERNA, 923275,,,U,"We have a patient that received the 1st vaccine, then 7days later they tested positive for COVID-19.; We have a patient that received the 1st vaccine, then 7days later they tested positive for COVID-19.; This is a spontaneous report from a contactable pharmacist (Pharmacy Intern) via Pizer-sponsored program: A patient of unspecified age and gender received first single dose of BNT162B2 (lot number, and exp date not reported), via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. The patient received the 1st vaccine, then 7days later tested positive for COVID-19 (date unspecified). It was asked if patient needed to wait 90 days to receive the 2nd Vaccine dose. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 923276,,,F,"tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first single dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, lot number and exp date not reported), via an unspecified route of administration on 17Dec2020 for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first Covid vaccine and on 26Dec2020, tested positive for Covid. Patient asked when if it was safe for her to get second dose. Asked if she get it on 21 days or if she had to wait. The outcome of the event was unknown. Information about Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/26/2020,9.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 923277,AR,42.0,F,"Headache, nausea, diarrhea, nerve-like pain, muscle pain. Took Advil and otc anti-diarrheal. Continues to have nerve pain, headache, and muscle pain. Today she obtained a red hot rash to injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,SEN,Progesterone,No,None,,PCN and Sulfa,"['Diarrhoea', 'Headache', 'Injection site reaction', 'Injection site warmth', 'Myalgia', 'Nausea', 'Neuralgia', 'Rash erythematous']",1,MODERNA,IM 923278,,,U,"had covid and also received the Pfizer covid 19 vaccine.; had covid and also received the Pfizer covid 19 vaccine.; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender started received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. They have a patient that meets the criteria to receive product bamlanivimab. The patient had Covid and received the Pfizer covid 19 vaccine. The nurse asked if patient can still get the bamlanivimab after receiving vaccine. The outcome of the events was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, it is unclear if Covid developed after BNT162B2 Pfizer covid 19 vaccine, pending further clarification, at this moment, the Company would handle the reported COVID related to the suspect, BNT162B2, for reporting purpose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 923279,NY,26.0,M,"Hematospermia, with no hematuria, dysuria, or dyspareunia. No recent sex, one female partner, oral sex only. Unlikely to have recent covid or other infection; I've been on vacation (at home, no travel) but did 2 days in non-COVID19 ICU on 1/5 and 1/6. Last intercourse one week ago, with no symptoms. ROS otherwise negative. On self-physical exam, no tenderness of testes, penis, suprapubic region, CVAT. Exam otherwise negative; unable to perform prostate exam on self.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,WRK,None,None,S/p partial orchiectomy for testicular hematoma from MVA in 2018,,NKDA,['Haematospermia'],1,PFIZER\BIONTECH,IM 923280,TN,40.0,F,"hsv-1 outbreak; sore arm redness and bruising at site; sore arm redness and bruising at site; sore arm redness and bruising at site; This is a spontaneous report from a contactable physician. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1204), intramuscular into the left arm on 23Dec2020 at 18:00 as single dose for COVID-19 immunization. Medical history included herpes simplex 1 (HSV1) from an unknown date. The patient's concomitant medications were not reported. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no allergies to medications, food, or other products. On 27Dec2020, patient experienced HSV-1 outbreak and sore arm redness and bruising at site. This was elaborated as 4- 5 days post vaccine, there was marked HSV-1 outbreak, different than typical outbreak and that was not responding to valacyclovir hydrochloride (VALTREX). There was also sore arm redness and bruising at site. The events were not serious. Therapeutic measures were taken as a result of the events as aforementioned (valacyclovir hydrochloride). The outcome of events, HSV-1 outbreak and sore arm redness and bruising at site was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/27/2020,4.0,PVT,,,Medical History/Concurrent Conditions: Herpes simplex type I,,,"['Herpes simplex', 'Vaccination site bruising', 'Vaccination site erythema', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 923281,IN,58.0,F,"Swelling deltoid muscle, headache, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Losartan/HCTZ,None,HTN controlled,,"Morphine, Sulfa, Flagyl","['Headache', 'Muscle swelling', 'Nausea']",UNK,PFIZER\BIONTECH, 923282,MD,62.0,F,"stomach cramping; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), via an unspecified route of administration on 28Dec2020 at 11:45 at 62-years-old at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 28Dec2020, the patient experienced: stomach cramping and diarrhea; which was assessed as non-serious. The clinical course was reported as follows: The patient stated she had the vaccine on 28Dec2020 at 11:45 and ""maybe an hour later"", her stomach start cramping and then had diarrhea. The patient wanted to know if that was something ""to be concerned about."" In regard to having any laboratory test, the patient stated, ""I went in November sometime for my annual checkup I think it was November"" (as reported). When the patient was asked if they received any treatment for the events, the patient stated, ""No. I am still at work, I got it today, I haven't taken anything but I was thinking that to just get some ""Caper"" (as reported) and ""gentian soda"" (as reported)."" The clinical outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Abdominal pain upper', 'Diarrhoea']",UNK,PFIZER\BIONTECH, 923283,CA,35.0,F,"flare of existing autoimmune disease (undifferentiated connective tissue disease (UCTD) with predominant features of systemic sclerosis); flare of existing autoimmune disease (undifferentiated connective tissue disease (UCTD) with predominant features of systemic sclerosis); flare of existing autoimmune disease (undifferentiated connective tissue disease (UCTD) with predominant features of systemic sclerosis); This is a spontaneous report from a contactable physician. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899) intramuscular on 22Dec2020 16:15 (04:15 PM) at a single dose on the left arm as COVID-19 vaccine. Medical history included autoimmune disease (undifferentiated connective tissue disease (UCTD) with predominant features of systemic sclerosis); secondary Raynaud's phenomenon with calcinosis; known allergies to sulfa drugs, pine nuts. Concomitant medications included mycophenolate mofetil (MMF) 1000mg bid (twice a day), hydroxychloroquine sulfate (PLAQUENIL) 300mg qd (once a day), and prednisone 15mg daily (received within 2 weeks of vaccination). The patient had an adverse event (AE) of flare of existing autoimmune disease (undifferentiated connective tissue disease (UCTD) with predominant features of systemic sclerosis) on 23Dec2020 09:00 PM (also reported as flare began about 36-48 hours after vaccine) which required increased daily dose of prednisone (higher dose) up to 80mg total daily dose (80mg daily x3d, then tapered down) (treatment received for AE) and lasted about 4-5 days. The patient was not pregnant at the time of vaccination. She had no other vaccine in four weeks (did not receive other vaccine within four weeks prior to the COVID vaccine). She was not diagnosed with COVID-19 prior to vaccination and did not have Covid tested post vaccination (had not been tested for COVID-19 since the vaccination). The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). The outcome of the events was recovered on Dec2020.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported flare of existing autoimmune disease (undifferentiated connective tissue disease (UCTD) with predominant features of systemic sclerosis) and the administration of BNT162B2, based on the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agencys, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,PVT,MMF; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE];,,"Medical History/Concurrent Conditions: Allergy to nuts (known allergies to sulfa drugs, pine nuts); Calcinosis; Raynaud's phenomenon; Sulfonamide allergy (known allergies to sulfa drugs, pine nuts); Systemic sclerosis; Undifferentiated connective tissue disease",,,"['Condition aggravated', 'Systemic scleroderma', 'Undifferentiated connective tissue disease']",1,PFIZER\BIONTECH,OT 923284,WI,31.0,M,"NO ADVERSE REACTION WITHIN FIRST HOUR OF VACCINE ADMINISTRATION. PT. REPORTS LOSS OF SENSE OF TASTE WITHIN HOURS OF RECEIVING THE VACCINE. PER PT. EMAIL REPORT, ""I noticed when I got home yesterday while eating supper I could not TASTE anything. I was eating a really garlicy meal and I kept putting more garlic on it as I couldn?t figure out why I couldn?t taste it. I am still having the same problem today. I am sure it will go away, but you said to let you know of any symptoms.""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PUB,UNKNOWN,UNKNOWN,UNDEFINED.,,UNKNOWN,['Ageusia'],1,PFIZER\BIONTECH,IM 923285,CA,31.0,F,"Palpitations; tachycardia; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: Ej1685), via an unspecified route of administration on the left deltoid on 22Dec2020 at SINGLE DOSE for COVID-19 immunization at the hospital. It was reported that prior to vaccination the patient was diagnosed with COVID-19 (unknown date). The patient's concomitant medications were not reported. The patient had palpitations and tachycardia on 23Dec2020 (also reported as second day post vaccine) which resulted to doctor or other healthcare professional office/clinic visit. The patient received unspecified beta blocker as treatment. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,,,Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination),,,"['Palpitations', 'Tachycardia']",1,PFIZER\BIONTECH, 923286,IL,47.0,M,"within 15 minutes of receiving vaccine, developed hives and became itchy, Benadryl was taken by the employee. Declined treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,zyrtec daily and Benadryl as needed,none,allergies,,"Shellfish, Iodine, Morphine, CT contrast, animal dander, rag weed, and seasonal allergies","['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 923287,,,F,"developed symptoms/mild/thought the symptoms were from the vaccine but turned out she did test positive for Covid; developed symptoms/mild/thought the symptoms were from the vaccine but turned out she did test positive for Covid; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Dec2020 at a single dose as vaccine. Medical history and concomitant medications were not reported. The patient received the vaccine on 19Dec2020 and 2 days later on 21Dec2020, she developed symptoms. Her symptoms had been mild. She thought the symptoms were from the vaccine but turned out she did test positive for Covid on Dec2020. She inquired what would happen if you get the vaccine and you test positive. She also inquired if her symptoms would be worse. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/21/2020,2.0,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 923288,CA,42.0,F,"8 days after vaccine given (1st dose), urticaria around site of injection which resolved within 24 hours with 180mg fexofenadine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/31/2020,8.0,PVT,none,none,none,,none,['Injection site urticaria'],UNK,PFIZER\BIONTECH, 923289,,,M,"positive for Covid/ symptoms of Covid; positive for Covid/ symptoms of Covid; This is a spontaneous report from a contactable nurse (reported for himself). A 33-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient got the first dose of the vaccine on 17Dec2020 and then around Christmas he developed symptoms of Covid (Dec2020). On 27Dec2020, he came back positive for Covid and wanted to know if he skip the second dose. Patient questioned what percentage of persons obtained immunity after the first product dose. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/01/2020,,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 923290,NY,,F,"tested positive for COVID-19 by PCR the following day and developed covid symptoms; tested positive for COVID-19 by PCR the following day and developed covid symptoms; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer-biontech covid-19 vaccine and tested positive for COVID-19 by PCR the following day and developed COVID symptoms. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported tested positive for COVID-19 by PCR after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 923291,TX,32.0,F,Patient developed a rash at site of injection approximately 3 inches wide and 4 inches long in size. Patient did not have or express any symptoms like itching or fever. Patient self treated with hydro- cortisone cream topically and benadryl 25mg orally. Duration of rash is still present but less than on 1/5/2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"multi-vitamin,CoQ10 200mg, Fish Oil 1000mg once daily for ea",None,hypercholesterolemia,,Almonds,['Injection site rash'],1,MODERNA,IM 923292,KS,48.0,F,"they suspect that I have rheumatoid arthritis; this is like abnormal I mean anybody with arthritis should not be a part of these trials; Never felt this kind of joint pain in my life/these are hitting my every joint in my hand, I can barely move; I have never been in as much pain in my life; I am really bad nauseous; soreness in your arm; This is a spontaneous report from a contactable consumer (patient) (Food service worker in the hospital). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. Medical history included Meniere's disease (reported 'Meniere's disease in my left ear'). The patient's concomitant medications were not reported. Consumer stated, ''I just took the COVID 19 vaccine I work at (institute name), (city name), I took it yesterday around 1 and all through the night; they suspect that I have rheumatoid arthritis I got an injection in one of my hips, my right hip and both my shoulders I can inject in cortisone injection and I have never felt this kind of joint pain in my life, I can barely move, I had been calling and I let my director know and anybody that has any kind of arthritis on these trials, I have never been in as much pain in my life and I am really bad nauseous.'' When offered for the website consumer stated, ''I just wanted to report the side effects, I am really nauseous and I can barely move; this is like abnormal I mean anybody with arthritis should not be a part of these trials.'' When probed if vaccine was prescribed by Physician, Consumer stated, ''No it was voluntary, it was not mandatory it was given my hospital administration.'' Product details for vaccine (LOT#, Expiration date, NDC#, UPC#): Consumer stated, ''EH9894, I think for the last number.'' Treatment for adverse events: Consumer stated, ''I don't have anything for nausea, I did take, they told to me take Ibuprofen my doctor said that it would help with the soreness in your arm, I take my Ibuprofen every six hours because it is prescribed to me, but I could barely move my, I can barely move; these are hitting my every joint in my hand.'' Expiry Date of Ibuprofen: 16Jul2021. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,,,PVT,,,Medical History/Concurrent Conditions: Meniere's disease (Meniere's disease in my left ear.),,,"['Arthralgia', 'Feeling abnormal', 'Mobility decreased', 'Nausea', 'Pain in extremity', 'Rheumatoid arthritis']",UNK,PFIZER\BIONTECH, 923293,,37.0,M,"Per patient, he started to feel mild nausea after vaccine once he was home on 01/05/21. Starting 01/06/201 patient nausea has worsened and has vomited multiple times and has lost appetite. He also reports a dry cough and slight tightness in airway but patient unsure if it is due to vomiting or cough. Patient able to speak complete sentences and able to ambulate independently with no shortness of breath.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,OTH,,"Per patient, rarely becomes sick.",none,,"Per patient, does not have any allergies.","['Cough', 'Decreased appetite', 'Nausea', 'Throat tightness', 'Vomiting']",1,MODERNA,IM 923294,CA,53.0,F,"Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported a 53-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown, did not see this information on the vaccination card), via an unspecified route of administration in the left arm on 20Dec2020 at single dose for covid-19 immunization (certified nurse assistant in healthcare). Other products, patient history and investigation assessment was No. There were no concomitant medications. The patient was vaccinated with the COVID Vaccine on 20Dec2020 but tested positive afterwards on 27Dec2020. The patent thought she had COVID in the vaccine and COVID in her body. She was scheduled for next dose on 10Jan2021 and would like to know if she should get the scheduled dose or if she needs to wait longer and re-schedule it. She was now a COVID patient and sick. She was waiting to get better. Before the vaccine she tested negative and felt great. Then she got the vaccine. She had a runny nose and felt achy. She asked her coworker, and her coworker felt the same. She thought if it continued that maybe it was a side effect. Caller confirmed her symptoms were runny nose, feeling achy, and coughing. She took Tylenol and the aches went away. They then came back, and she had more aching and she was wondering why. Caller clarified that these symptoms did not start the next day after receiving the vaccine. Achiness/body aches was started on 23Dec2020 when she was at work. It would wake her up at night. She did have aches right now, but her fever had lowered down. She was also dizzy and weak. It was affecting her legs and she had no taste. She was not eating but needs to eat. If she did, she eat something sweet. Runny nose was started on 24Dec2020. She went back to work on 26Dec2020 but told them she could not work because she had symptoms of COVID. She went to her second job where they do COVID testing and asked her boss for a test. She tested positive on 27Dec2020. Dose was unknown. She said she thought she got 1 vial. The whole thing. The outcome of events ""tested positive for COVID after receiving the vaccine"" was not recovered. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/01/2020,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Ageusia', 'Asthenia', 'Cough', 'Decreased appetite', 'Dizziness', 'Impaired work ability', 'Malaise', 'Muscular weakness', 'Pain', 'Pyrexia', 'Rhinorrhoea', 'SARS-CoV-2 test positive', 'Sleep disorder']",1,PFIZER\BIONTECH, 923296,WA,44.0,M,"Back of Left eye hurts, sinus near left eye feels swollen, mild headache; Back of Left eye hurts, sinus near left eye feels swollen, mild headache; Back of Left eye hurts, sinus near left eye feels swollen, mild headache; Back of Left eye hurts, sinus near left eye feels swollen, mild headache; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient started to receive BNT162B2 (also reported as "" Pfizer COVID-19 Vaccine""), Lot number: EL0142, via an unspecified route of administration on 27Dec2020 18:45 at single dose (dose 1) in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. Medical history included food allergies: shrimp. Concomitant medication included guaifenesin (MUCINEX). On 28Dec2020 06:00, the patient experienced back of left eye hurts, sinus near left eye feels swollen and mild headache. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/28/2020,1.0,PVT,MUCINEX,,"Medical History/Concurrent Conditions: Seafood allergy (Allergies to medications, food, or other products: Shrimp)",,,"['Eye pain', 'Eye swelling', 'Headache', 'Sinus disorder']",1,PFIZER\BIONTECH, 923297,ID,31.0,F,"Red arm, soreness at site, swollen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Erythema', 'Injection site pain', 'Swelling']",1,MODERNA,IM 923298,FL,38.0,F,"Right arm Swollen and tender lymph node; Right arm Swollen and tender lymph node; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), intramuscular at the right arm on 28Dec2020 12:00 at a single dose for COVID-19 immunization. Medical history included psoriasis, psoriatic arthritis, chronic back pain and childhood asthma. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient known allergies was tramadol. On 29Dec2020, the patient experienced right arm swollen and tender lymph node. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Childhood asthma; Chronic back pain; Psoriasis; Psoriatic arthritis,,,"['Lymph node pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH,OT 923299,NH,43.0,M,"I have cold and numbness and a dull ache in the arm of the injection; I have cold and numbness and a dull ache in the arm of the injection; I have cold and numbness and a dull ache in the arm of the injection; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: Eh9899), via intramuscular route of administration, on 19Dec2020 (at the age of 43 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history was Hypertension. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, the patient experienced cold, numbness and a dull ache in the arm of the injection. No treatment was received for the events cold, numbness and a dull ache in the arm of the injection. The outcome of the events cold, numbness and a dull ache in the arm of the injection was not recovered. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/19/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Hypertension,,,"['Vaccination site coldness', 'Vaccination site discomfort', 'Vaccination site hypoaesthesia']",UNK,PFIZER\BIONTECH,OT 923300,IN,48.0,F,"Chills/shivering, body aches, nausea, fatigue, extreme pain and tenderness at the injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,WRK,"LoEstirn, Synthroid, Zoloft, Claritin, Calcium, Vitamin D, Fiber",None,Thyroid cancer,,None,"['Chills', 'Fatigue', 'Injection site pain', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 923301,MD,59.0,M,"Arm soreness; Feeling of fever for 48 hrs (but no fever); Malaise; Fatigue; Headache; Severe heart burn for 48 hrs; One episode of watery diarrhea; One episode of vomiting; This is a spontaneous report received from a contactable physician (who is also the patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in left arm, on 23Dec2020 09:30 at single dose for COVID-19 immunization. Medical history included being overweight, prediabetes, hyperlipidaemia and Known allergies: Statins. Concomitant medication included fish oil, ergocalciferol (VITAMIN D), ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (ARED-2 VITAMINS) and finasteride. The patient experienced arm soreness, malaise, fatigue and headache, severe heart burn for 48 hrs, one episode of watery diarrhea, one episode of vomiting and feeling of fever for 48 hrs (but no fever) all on 23Dec2020 at 10:00. Treatment included unspecified antacids and proton pump inhibitors (PPI). The patient did not have COVID prior to vaccination. The patient was tested for COVID on 25Dec2020 post vaccination (nasal swab for rapid test and antibody test on 25Dec2020 which resulted to negative). The outcome of the event Feeling of fever for 48 hrs (but no fever) was recovered on 25Dec2020 at 10:00 and the patient recovered from the remaining events on an unspecified date in Dec2020. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,; VITAMIN D [ERGOCALCIFEROL]; Ared-2 Vitamins;,,Medical History/Concurrent Conditions: Drug allergy; Hyperlipidemia; Overweight; Prediabetes,,,"['Diarrhoea', 'Dyspepsia', 'Fatigue', 'Headache', 'Malaise', 'Pyrexia', 'SARS-CoV-2 test', 'Vaccination site pain', 'Vomiting']",UNK,PFIZER\BIONTECH, 923302,IL,27.0,F,On 12/25/20 pt experience swelling of the R eyelid. By 12/26 the eyelid was swollen shut. Patient received treatment of antibiotics and MEdrol dose pack and swelling decreased. As of 1/5 eyelid was still slightly swollen.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/25/2020,8.0,PVT,,,,,None,['Eyelid oedema'],1,PFIZER\BIONTECH,IM 923303,,,F,"testing positive for COVID after getting the vaccine; testing positive for COVID after getting the vaccine; This is a spontaneous report from a contactable Other Health Professional reported for herself. A female patient of an unspecified age (reported as 42) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after getting the vaccine in Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included COVID test in Dec2020: negative; positive. The reporter would like an explanation as to the rapidness of her testing positive for COVID after getting the vaccine. Can the vaccine cause false positive test results? Information on interpretation of SARS-CoV-2 test results. The patient tested negative on Monday, got the vaccine on Monday. However tested positive today, asymptomatic. Information about batch/lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/01/2020,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 923304,MN,34.0,F,"Right arm: Painful; Swollen axilla lymph nodes; tender lymph node; Severe Pain at elbow; This is a spontaneous report from a contactable nurse (Patient). A 34-year-old non-pregnant female patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EL0140), via an unspecified route of administration in right arm on 21Dec2020 09:45 at single dose for covid-19 immunization in hospital. The patient's medical history was not reported and there was no known allergies. The patient's concomitant medications were not reported. There was no other vaccine in four weeks. The patient experienced right arm painful, swollen axilla lymph nodes, tender lymph node and severe pain at elbow on 26Dec2020. The events was non-serious. Th events result in Doctor or other healthcare professional office/clinic visit. There was no treatment. The outcome of the events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/26/2020,5.0,PVT,,,,,,"['Arthralgia', 'Lymph node pain', 'Lymphadenopathy', 'Vaccination site pain']",1,PFIZER\BIONTECH, 923305,PA,28.0,F,"Heart rate went to 133 at 12:45pm for 6 minutes; face and ears were swollen; face and ears were swollen; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231), via an unspecified route of administration at the left arm on 29Dec2020 11:15 at a single dose for COVID-19 immunization. The patient was obese with BMI of 32, known allergies were tree nuts, sunflower seeds sesame seeds. The patient was not pregnant at the time of vaccination. Concomitant medication includes vitamins nos (DAILY MULTIVITAMIN). On 29Dec2020, heart rate went to 133 at 12:45pm for 6 minutes. The patient took TYLENOL and BENADRYL and went to sleep. When she woke up her face and ears were swollen, heart rate is back to normal (29Dec2020). The patient also added that swelling was a reaction she normally gets when she eats something she was allergic too. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events face and ears were swollen was recovering; heart rate went to 133 at 12:45pm for 6 minutes recovered on 29Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,DAILY MULTIVITAMIN,,Medical History/Concurrent Conditions: Allergy to nuts; Food allergy; Obesity,,,"['Body mass index', 'Ear swelling', 'Heart rate', 'Heart rate increased', 'Swelling face']",1,PFIZER\BIONTECH, 923306,NY,57.0,F,"palpitations, numbness B/L UE, elevated BP",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,,,,,epinephrine,"['Blood pressure increased', 'Hypoaesthesia', 'Palpitations']",1,MODERNA,IM 923307,,,U,"elevated heart rate; shortness of breath; painful lymph nodes; This is a spontaneous report from a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. A non-contactable consumer reported that a patient of unspecified age and gender started to receive bnt162b2 (BNT162B2), via an unspecified route of administration from an unspecified date at a single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated ""I had side effects for 4 days"". this patient experienced elevated heart rate, shortness of breath and painful lymph nodes on an unspecified date. Outcome of events was reported as unknown. Patient was nervous about having the second dose but later stated s/he was all in. No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Dyspnoea', 'Heart rate', 'Heart rate increased', 'Lymph node pain']",UNK,PFIZER\BIONTECH, 923308,IN,26.0,M,"Severe pain in arm where injection occurred, chills, aches, and low fever. Peaked around 6 hours after vaccination. Similar but less severe symptoms the second day in the evening",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Synthroid, daily multivitamin",None,Hypothyroidism,,None,"['Chills', 'Injection site pain', 'Pain', 'Pyrexia']",UNK,MODERNA,SYR 923309,PA,32.0,F,"Diarrhea, chills, injection site soreness; Diarrhea, chills, injection site soreness; Diarrhea, chills, injection site soreness; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: Ek9231), via intramuscular route of administration, on 29Dec2020 at 08:45 AM (at the age of 32 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history was none. Past drug history was allergy to Pediazole. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020, at 07:30: AM, the patient experienced diarrhea, chills and vaccination site soreness. No treatment was received for the events diarrhea, chills and vaccination site soreness. The outcome of the events diarrhea, chills and vaccination site soreness was not recovered. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,,,,,,"['Chills', 'Diarrhoea', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 923310,NY,57.0,F,"Feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at lesser effect); Intermittent dizziness after an hour; H/A after an hour; that diminished over the next 12 hours but slightly lingered; Metallic taste in the mouth after an hour; Nausea after 8 hours (diminished by the next morning); This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscular on the left arm on 29Dec2020 09:45 at a single dose for COVID-19 immunisation. Medical history included Hashimoto. Concomitant medication included omeprazole, rosuvastatin calcium (CRESTOR), levothyroxine, magnesium and ascorbic acid, retinol, tocopherol (OCUVITE). The patient previously took zinc and experienced allergies. On 29Dec2020, the patient experienced intermittent dizziness after an hour, metallic taste in the mouth after an hour, H/A (headache) after an hour (that diminished over the next 12 hours but slightly lingered) and feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at lesser effect), and nausea after 8 hours (diminished by the next morning). No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Outcome of the events was recovered with sequel.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,; CRESTOR; ; ; OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL],,Medical History/Concurrent Conditions: Hashimoto's disease,,,"['Dizziness', 'Dysgeusia', 'Fatigue', 'Headache', 'Nausea']",UNK,PFIZER\BIONTECH,OT 923311,CA,62.0,F,"Patient reports hot and cold flashes and felt that she may pass out, she went to ER and everything else is okay",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/24/2020,1.0,WRK,,,,,,"['Dizziness', 'Feeling cold', 'Hot flush']",UNK,PFIZER\BIONTECH, 923312,NY,,M,"Had the vaccine eventually then I ended up getting the virus; I ended up going through a rapid test that turned positive; This is a spontaneous report from a contactable consumer reporting for himself. A 53-years-old male patient started to receive bnt162b2 (BNT162B2; Lot # EK5730) vaccine , intramuscular in the left arm on an unspecified date at single dose for Covid-19 immunisation . Medical history included hypothyroidism from an unknown date. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient stated that he does get test for the virus twice weekly. He did end up getting the Pfizer, the first round of Pfizer vaccine a week ago. The patient had a test, a virus test before, a swab test afterwards, both were negative but by Christmas eve the patient started getting, what he thought was side effect of the vaccine and he ended up going through a rapid test and it turned out he was positive for the virus.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,SYNTHROID,,Medical History/Concurrent Conditions: Hypothyroidism (Verbatim: Hypothyroidism),,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH,OT 923313,NY,44.0,F,"arm pain/arm is sore where she got the shot; shivering; body aches; headache; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the arm on 29Dec2020 at 15:20 at single dose for COVID-19 immunization. Medical history included thyroid issue, low blood pressure from an unknown date and unknown if ongoing, surgery for an ovarian cyst in 1999 (She had surgery for an ovarian cyst 21 years ago), cyst on her tailbone removed in 2016 (had cyst on her tailbone removed 5 times. The first removal was in 2016. It was removed twice in 2017 and then twice in 2018). Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid issue. The patient got the vaccine on Monday (29Dec2020) and waited the 15 minutes then felt okay. Then on Tuesday (30Dec2020) she developed/woke up with arm pain and shivering, body aches and mild headache. She woke up with arm pain, shivering, body aches, and headache. The patient states it is very mild. She is sitting there shivering and has body aches. No joint pain. Her arm is sore where she got the shot. When you feel pain, you automatically have a headache. Side effects started this morning around 9:30AM or 9:45AM. She felt nothing when she was in the bed. When she went into living room for breakfast she felt shivering. She called her friend that got the injection yesterday too and her friend feels ok and gave her the number to call. Therapeutic measures were taken as a result of the events which included treatment with Tylenol. The patient was recovering from the events. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,UNK,SYNTHROID,,Medical History/Concurrent Conditions: Bone cyst; Bone cyst excision (removed 5 times. The first removal in 2016. Removed twice in 2017 and twice in 2018.); Low blood pressure; Ovarian cyst; Ovarian surgery (She had surgery for an ovarian cyst 21 years ago.); Thyroid disorder,,,"['Chills', 'Headache', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 923314,IA,41.0,F,"Estimated due date: 02/07/2021. Will probably be induced a week earlier. I felt mild pain in my arm in the evening of the 31st and then the pain started from my elbow to my neck on my right side. I went to sleep and woke up with general malaise, chills, body ache, sore throat, headache. the same feeling I had when I had covid, a heaviness in my chest, almost like a shortness of breathe. I was flushed and felt feverish although I never had a fever. The symptoms lasted all day. On the first also my arm pain was severe, I could not even lift it the whole day. I went to sleep on 01/01 and when I woke up on 01/02 the symptoms were all gone. I took Tylenol 3 times to help me with the symptoms. 3 grams total in 24 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PHM,"Baby aspirin 81mg, serotonin and prenatal vitamin",36 days prior to receiving the vaccine I was positive for COVID (11/25/2020),no,,no,"['Chest discomfort', 'Chills', 'Dyspnoea', 'Flushing', 'Headache', 'Malaise', 'Neck pain', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 923315,MI,47.0,F,"Weakness; Tingling in arm that was vaccine was given; Fever; Extreme fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EC1284), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced extreme fatigue, tingling in arm that was vaccine was given, fever, and weakness on 30Dec2020. No treatment was given for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,UNK,,,,,,"['Asthenia', 'Fatigue', 'Paraesthesia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 923316,OH,30.0,F,"Fatigue; Muscle soreness in the arms, neck, and upper back; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient started received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular on left arm on 16Dec2020 13:30 at single dose for COVID-19 immunization. Medical history included obstructed sleep apnea, chronic sinusitis, and obesity. The patient has no known allergies. There were no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at a hospital and the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experience muscle soreness in the arms, neck, and upper back as well as fatigue on 17Dec2020 12:00 (starting about 24 hours after the vaccination). The symptoms were resolved by the next day (Dec2020), or approximately 48 hours after the vaccination. No treatment was given for the events. Information about lot/batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/17/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Chronic sinusitis; Obesity; Sleep apnea syndrome,,,"['Fatigue', 'Myalgia']",1,PFIZER\BIONTECH,OT 923317,UT,60.0,F,"Monday, January 4 in the evening I became very fatigued, to the point where I couldn't stay awake. When I woke up a few hours later, I noticed that I had a very bad headache and all-over body aches, and I felt like I had the flu. Weak, nauseous and extremely tired. I went to bed and slept through the night, when my alarm woke me at 7:00 am on Tuesday, January 5, I got up to use the bathroom and felt all the same symptoms from the night before, only worse. I noticed that I had a rash on my left arm below the injection site. I called in sick and went back to bed. I slept from approximately 7:30 to 2:00 pm on January 5. I felt a little better upon awakening, but had a very bad headache and no appetite. The other body aches seemed better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/04/2021,5.0,PUB,"Protonix, Synthroid, Gabapentin, Xanax, Venlafaxine, Zyrtec",Type 2 Diabetes,Type 2 Diabetes,,None,"['Asthenia', 'Decreased appetite', 'Fatigue', 'Headache', 'Impaired work ability', 'Influenza like illness', 'Injection site rash', 'Nausea', 'Pain', 'Somnolence']",UNK,MODERNA,IM 923318,CO,43.0,F,"I have been experiencing body ache throughout my whole body, pain if stay in one position to long on right hip or lower; headaches; I experienced dizziness, felt giddy/light headed; Then at night my whole body felt sore, ached on lower back and right side of my hip; Then at night my whole body felt sore, ached on lower back and right side of my hip; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (left arm) on 29Dec2020 at 07:30 AM, at a single dose, for COVID-19 immunization. The patient has no relevant medical history. The patient has no known allergies. Concomitant medications were not reported. Patient did not receive other vaccine four weeks prior COVID vaccination. The patient did not have COVID prior vaccination. The vaccine was administered in the hospital. Same day of shot, the patient experienced dizziness, felt giddy, then at night her whole body felt sore, ached on lower back and right side of her hip. In the morning of 30Dec2020, patient experienced body ache throughout my whole body, pain if stay in one position to long on right hip or lower back and legs, light headed and headaches. The patient did not receive treatment for the events. Outcome of the events was unknown. Since the vaccination, the patient has not been tested for COVID-19. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Back pain', 'Dizziness', 'Headache', 'Musculoskeletal discomfort', 'Pain']",1,PFIZER\BIONTECH, 923319,KY,66.0,F,"Severe stomach cramps; severe stomach cramps and bloating; This is a spontaneous report from a contactable other hcp (patient). A 66-year-old female patient received first dose of BNT162B2 (Pfizer product, lot number: EK9231), intramuscular on 29Dec2020 16:00 at single dose on right arm for COVID-19 immunization. Medical history included penicillin allergy. Concomitant medication included chondroitin;glucosamine, biotin, vitamin d nos, zolpidem tartrate (AMBIEN) and Women's Daily Vitamin. The patient previously took codeine and experienced drug allergy. The patient experienced severe stomach cramps and bloating 19 hours after vaccine (30Dec2020 11:00). Took ""Digestive Advantage"" and symptoms let up after 1 hour. The patient did not receive other vaccine in four weeks. No covid prior vaccination; no covid tested post vaccination. The patient was not pregnant at the time of vaccination. Therapeutic measures were taken as a result of the events. The outcome of the events was resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PUB,; ; ; AMBIEN,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Abdominal distension', 'Abdominal pain upper']",1,PFIZER\BIONTECH,OT 923320,IN,43.0,F,Induration at the injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,WRK,Lisinopril Hydrochlorothiazide Metformin Lexapro,None,HTN Pre-diabetes,,Penicillin,['Injection site induration'],2,MODERNA,IM 923321,AZ,37.0,F,"Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dream; Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dream; cold; Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dream; feeling unwell that night, unable to sleep, tossing and turning all night; feeling unwell that night, unable to sleep, tossing and turning all night; This is a spontaneous report from a contactable nurse (patient herself). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration (left arm), on 29Dec2020 at 15:15, at a single dose, for COVID-19 immunization. Relevant medical history included food allergy (known allergies: raw bananas, avocados, melons, kiwi, tomatoes, oranges, grapes-make her mouth and lips itch). Concomitant medications were not reported. The patient previously received ibuprofen 400mg, a couple doses week prior. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. Patient is not pregnant at the time of vaccination. On 29Dec2020, at 21:00, patient experienced worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dreams. When she was able to sleep, she was still feeling unwell the next morning like she was recovering from a cold. The patient did not receive treatment for the events. Outcome of the events was recovering. Since the vaccination, patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,UNK,,,"Medical History/Concurrent Conditions: Food allergy (Raw bananas, avocados, melons,kiwi, tomatoes, oranges, grapes-make my mouth and lips itch)",,,"['Abnormal dreams', 'Insomnia', 'Malaise', 'Movement disorder', 'Nasopharyngitis', 'Vaccination site pain']",1,PFIZER\BIONTECH, 923322,TX,48.0,F,"Tested positive for COVID /she received the first dose of the vaccine last 16Dec2020 but tested positive via Nasal Swab test on 24Dec2020; Tested positive for COVID/positive via Nasal Swab test/fever/body aches/headaches/She was very very weak, almost lethargic/felt really bad/fatigued; gas; bloated; the weight last week she was 167 and this week she was 180; This is a spontaneous report from a contactable nurse reporting for herself. A 48-year-old female patient received her first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) Lot #EH9899, via an unspecified route of administration on 16Dec2020 at single dose by injection in the right deltoid for COVID-19 immunisation. Medical history included borderline hypertension from 2018 and ongoing. Concomitant medication included olmesartan medoxomil (BENICAR) from 2018 and ongoing for borderline hypertension. The nurse reported that she received the first dose of the vaccine last 16Dec2020 but tested positive via Nasal Swab test on 24Dec2020. She said this kinda weird. She received the COVID vaccine on 16Dec2020. She tested positive for COVID on 24Dec2020. Obviously she was exposed to COVID prior to the vaccine. She was scheduled to have the 2nd dose on 05Jan2021 but her hospital deferred it to 23Mar2021. She was asking if this was what's recommended.She said this was another weird thing, regarding the weight last week she was 167 and this week she was 180 (in Dec2020). She was very bloated in Dec2020, it was bizarre. He husband did not receive the vaccine and had symptoms on 24Dec2020. She had normal seasonal allergy symptoms. She did not think much of it. She took her Xyzal and her normal things.She took her husband to get tested and he tested positive, so she got tested, and was positive. She worked at (address withheld), and all of her patients were immunocompromised. She was shocked. She did not think this had anything to do with the vaccine. If anything, it has helped her fight the virus.By Christmas day 25Dec2020 her fever was 102, she had body aches, she went into overdrive. She had headaches and lots of gas in Dec2020.She went into overdrive from partial recognition from the vaccine.She was very very weak, almost lethargic. Her O2 saturation have stayed good around 98% in Dec2020. She has done really well. Yesterday or the day before she felt really bad again. She did a virtual visit with (name withheld), and the doctor started her on steroids and gave her an inhaler just in case she needed it. She felt better on 30De2020. On 29De2020 she was so bad and bloated, she only had one dose of the steroids, but had unusual weight gain. Then 2 pounds were gone this morning on 30De2020.She had no pitting edema or edema period. She was very fatigued, but had more energy this morning, probably because of the steroids. She had the vaccine, even though day 7 post-injection, instead of day 10, which was about 50%, her body reacted more so than her husbands because her body recognized it. The outcome of the events was unknown. She was unsure of the outcome. It was up and down. She has felt worse and she has felt better. The reporter considered the event Tested positive for COVID was Not serious and unrelated to the BNT162B2.; Sender's Comments: While reporter causality is noted, a possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/01/2020,,PVT,BENICAR,Borderline hypertension,,,,"['Abdominal distension', 'Asthenia', 'Fatigue', 'Feeling abnormal', 'Flatulence', 'Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive', 'Viral test positive', 'Weight increased']",1,PFIZER\BIONTECH, 923323,AZ,30.0,M,"7 minutes after receiving injection patient developed left jaw pain, pain behind eyes, dizziness, nausea and 2 episodes of vomiting. Given antiemetic medication and ibuprofen for symptomatic treatments. Monitored in the ED for several hours without new or worsening symptoms. Of note, patient was seen for left jaw pain, pain behind eyes and dizziness on Dec 26 in the ED as well. States these symptoms were thought to be improving until dose of vaccine, symptoms returned. New symptom is N/V after dose of vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,"Citalopram, loratadine, methocarbamol","left jaw pain, dizziness, pain behind eye","Depressive disorder, GERD, hx of smoking",,no,"['Dizziness', 'Electrocardiogram normal', 'Eye pain', 'Nausea', 'Pain in jaw', 'Sinus rhythm', 'Vomiting']",1,MODERNA,IM 923324,MN,64.0,M,"Bell's palsy on the left side of his face; Headaches; Overall was not feeling well; This is a spontaneous report from contactable consumers (including the patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration in right arm on 18Dec2020 04:00 at a single dose for covid-19 vaccination. There were no relevant medical history and concomitant medications. On, 19Dec2020, the patient had headaches and overall was not feeling well. On 28Dec2020, the patient experienced bell's palsy on the left side of his face. He said it was a little hard to talk as his mouth was not working at the moment. The provider he saw gave him steroids- Prednisone, and Valaciclovir. He was also told to get some eyedrops as one eye does not close very well. He laughed and said it was a little hard to drink his coffee. The outcome of the events headache and not feeling well was recovered on 21Dec2020 while the outcome of bell's palsy was not recovered. The information on the batch/lot number and expiration date has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/19/2020,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dyskinesia', 'Eyelid function disorder', 'Facial paralysis', 'Headache', 'Malaise', 'Speech disorder']",UNK,PFIZER\BIONTECH, 923325,MA,43.0,F,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable physician reporting for a nurse (patient) from a Pfizer-sponsored program Pfizer First Connect. A 43-year-old female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. There were no medical history and concomitant medications. The physician was reporting that a nurse received the vaccine and had a headache after receiving it. She also tested positive for Covid 6 days after getting the vaccine (on 28Dec2020). He was asking if there was any connection with getting the first shot and testing positive. She was very keen with social distancing and wearing a mask. The physician is a medical oncologist. He was reporting on one of the nurses that worked at the hospital. She also developed nasopharyngeal congestion 4-5 days later. The nurse was at work today. She was disappointed because she had to go home. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 28Dec2020. The outcome of the events was unknown. Information on Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/28/2020,6.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Headache', 'Impaired work ability', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 923326,,,U,has tested positive shortly after; has tested positive shortly after; This is a spontaneous report from a contactable pharmacist. A patient of unknown age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The pharmacist asked for recommendation for the 2nd dose of the patient who had received the 1st dose but had tested positive shortly after. The outcome of the events was unknown. information on the LOT/Batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 923327,IN,29.0,F,Feverish Chills Fatigue Runny nose,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,None,None,None,,Demerol,"['Chills', 'Fatigue', 'Pyrexia', 'Rhinorrhoea']",UNK,PFIZER\BIONTECH, 923329,NY,29.0,F,"palpitations; Shortness of breath; Heart rate was 160s; This is a spontaneous report from a contactable Physician. This 29-Year-old female physician reported that she received 1st dose of BNT162B2 on 30Dec2020 08:30 AM at right arm for COVID-19 immunisation. Medical history included allergies: Citrus and cinnamon- perioral contact dermatitis. Concomitant therapy included birth control- Mylan. The patient reported within 5 mins of vaccine administration, she experienced palpitations and shortness of breath. Heart rate was 160s on 30Dec2020. No rash or fever. Event onset time was reported as 30Dec2020 8:30. She needed to be taken to the emergency room. Treatment was received as Steroids epinephrine Benadryl. The outcome of the event was recovering. The events were reported as non-serious. Lot/Batch and Expiration date has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Allergic contact dermatitis; Fruit allergy; Spice allergy,,,"['Dyspnoea', 'Palpitations']",1,PFIZER\BIONTECH, 923330,MI,36.0,F,Severe insomnia. Started the night of 1/1/2021. Was unable to fall asleep despite being tired. This is not normal for me. This has continued every night. I am unable to fall asleep despite being exhausted. Once asleep I am waking up within an hour and a half to two hours and not able to go back to sleep. Over the past 5 nights I have averaged 2 hours a sleep night and no day time naps.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,WRK,None,None,None,,Beeswax,"['Fatigue', 'Initial insomnia', 'Insomnia', 'Poor quality sleep']",1,PFIZER\BIONTECH,IM 923331,AR,56.0,F,"started spotting this morning; low back pain mild; breast tenderness; abdominal pain mild; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 30Dec2020 this case now contains all required information to be considered valid. A contactable nurse (patient) reported a 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EH9899), intramuscular on the left deltoid on 17Dec2020 at SINGLE DOSE for COVID-19 vaccination at the hospital, estradiol (ESTRADIOL gel), oral from May2020 and ongoing at 1 mg, 1x/day for menopause and progesterone (PROGESTERONE tablet), oral from May2020 and ongoing at 100 mg, 1x/day for menopausal symptoms. Medical history included blood pressure issues since 2000 and ongoing. The patient was also menopausal (ongoing). Concomitant medication included losartan (LOSARTAN) for blood pressure issues. On 28Dec2020, the patient experienced abdominal pain mild. She also had low back pain mild and breast tenderness noted on 29Dec2020. The patient also stated that she felt like she was going to have a period even she has not had a period in 3 years as she was on progesterone and estradiol. The patient will see doctor to make sure that it was not anything. On 30Dec2020, the patient reported that she started spotting this morning. The patient did not receive any treatments for the events. The action taken in response for progesterone and estradiol as dose not change. The patient recovered from abdominal pain mild on 28Dec2020; low back pain mild and breast tenderness on 29Dec2020. Stated that the spotting resolved at noon on 30Dec2020. The reporter considered the events as non-serious. The reporter also considered that the events were related to Pfizer BioNTech Vaccine while unrelated to estradiol and progesterone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,05/01/2020,12/28/2020,241.0,PVT,,Blood pressure abnormal; Menopause,,,,"['Abdominal pain', 'Back pain', 'Breast tenderness', 'Vaginal haemorrhage']",UNK,UNKNOWN MANUFACTURER,OT 923332,MT,46.0,F,"Dizziness, flushing",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Dizziness', 'Flushing']",1,PFIZER\BIONTECH,IM 923333,NC,59.0,F,"Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; This is a spontaneous report from a contactable Other Health Professional (patient). This 59-year-old female Other Health Professional (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ej1685) on 21Dec2020 11:00 AM at single dose in Left arm for covid-19 immunization. Medical history was hypertension, hypothyroidism. Concomitant drug included levothyroxine/liothyronine (NP THYROID), HCTZ, Amlodipine. No other vaccine in four weeks. Started with aches in the back NA increased temp swollen lump nodes under the arms and neck bottoms of the feet swollen from 27Dec2020 with outcome was recovered. No treatment. No covid prior vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19: negative on 28Dec2020. No follow up attempts are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/27/2020,6.0,PVT,; HCTZ; NP THYROID,,Medical History/Concurrent Conditions: Hypertension; Hypothyroidism,,,"['Back pain', 'Body temperature', 'Body temperature increased', 'Lymphadenopathy', 'Peripheral swelling', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 923335,MI,53.0,F,"associate states she has hx of allergic reactions to vaccines; i.e flu. patient came in c/o of vision problems and numbness to entire body. Benadryl 25mg PO given at 1106. VS: BP 149/122, oxygen 90%, and HR 77 at 11:14 1119: 186/116, HR 79, and oxygen 95%. 1123: 206/102, HR 89, oxygen 96% 1125: EMS called.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,,,asthma,,"sulfa, PCN, codeine, shellfish, iodine, contrast","['Allergy to vaccine', 'Blood pressure increased', 'Heart rate increased', 'Hypoaesthesia', 'Visual impairment']",1,PFIZER\BIONTECH,IM 923336,,,F,"tested positive; tested positive; This is a spontaneous report from a contactable Nurse. A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Dec2020 (reported as about 3 days ago, as of 30Dec2020) at single dose for covid-19 immunisation. Medical history, concomitant medications or past drug history were not provided. She received the vaccine about 3 days ago and later tested positive in Dec2020 and asked if the patient needs to restart the 2 doses series. Outcome of the events were unknown. Lot/Batch and Expiration date has been requested.; Sender's Comments: The reported events drug ineffective and COVID-19 are likely intercurrent conditions and are unrelated to BNT162B2 based on the short temporal relation between vaccination and onset of event.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,12/01/2020,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 923337,,,F,"Caller stated that a patient tested positive for covid 19 after the first dose of the vaccine; Caller stated that a patient tested positive for covid 19 after the first dose of the vaccine; This is a spontaneous report from a contactable Pharmacist. A female patient of an unspecified age (age: 74; unit- unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for COVID 19 after the first dose of the vaccine. Reporter wants to know if the patient can be treated with monoclonal antibodies after having received the vaccine. Reporter also wanted to know if the storage in the thermal shipper can be extended past the 30 days. Event outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events drug ineffective and COVID-19 are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 923338,,,U,"Patient who got the vaccine a week ago tested positive now for COVID; Patient who got the vaccine a week ago tested positive now for COVID; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose bnt162b2 (BNT162B2), via an unspecified route of administration on Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The pharmacist reported the patient who got the vaccine a week ago tested positive now for covid on Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included covid: positive on Dec2020. the doctor is thinking of giving antibody. The event was reported at non-serious. Information on lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 923339,ID,31.0,F,"Arm redness, sore and swollen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Erythema', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 923340,,32.0,M,"Moderate to severe Chills; body and head aches; head aches; Fever (99.6 F); This is a spontaneous report from a non-contactable other hcp. A 32-year-old male patient received BNT162b2 (COVID 19, Lot number: EK9231, dose number was 1), intramuscular at right arm on 28Dec2020 08:00 AM at single dose for COVID-19 immunization in hospital. Medical history was none. There was no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. There was no other vaccine in four weeks. The patient experienced Moderate to severe Chills, body and head aches, and Fever (99.6 F) on 28Dec2020 20:30(08:30 P.M). There was no treatment. There was no COVID prior vaccination nor COVID tested post vaccination. Outcome was recovering. Events were assessed as non-serious by the reporter. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported event chills cannot be excluded based on known safety profile of suspect drug and compatible temporal relation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,OT 923341,,,F,"bell's palsy; This is a spontaneous report from a contactable physician. A female patient of an unspecified age (age: 37 unit: unknown), received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bell's palsy on 30Dec2020. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bell's palsy might not be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,UNK,,,,,,['Facial paralysis'],UNK,PFIZER\BIONTECH, 923342,TN,49.0,F,"Patient complained of increased heart rate(148) and "" mu throat feels funny"" holding her hand to her throat. mild shortness of breath with great anxiety. 0.5 of epinephrine and 50 mg of Benadryl given IM and EMS notified , after evaluation by EMS ,and 30 minutes of time had elapsed,patient declined transport, stating "" I am better"" she called and family member and left with them. heart rate was 148, respiration 32 and blood pressure 186/102",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,,,,,,"['Anxiety', 'Dyspnoea', 'Heart rate increased', 'Oropharyngeal discomfort']",1,MODERNA,IM 923343,MO,51.0,F,"felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling going down arm/ tingling down to her fingers; A little nausea/nauseated; real tired/ exhausted; muscle aches, just achy feeling; a little dizzy; sinus congestion; feel bad enough; didn't have enough energy; swollen lymph node; its like a little bitty lump in her throat; lymph node's a little bit tender; stated that her head feels congested almost like sinus pressure; stated that her head feels congested almost like sinus pressure; This is a spontaneous report from a contactable nurse reported for self. This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 29Dec2020 15:15 at single dose for covid-19 immunisation. Medical history included migraine, stated that the pressure triggers migraines and she was not going there. Concomitant medications were not provided. Past drug history included stated she took Excedrin migraine because she has history of migraines. She stated it felt like she had the flu, didn't have a temperature and never had a temperature. The first symptom was a dry cough and arm hurt so bad it was tingling going down arm/ tingling down to her fingers and now it felt much better and was able to move. A little nausea/ nauseated, kind of like flu symptoms, was real tired/ exhausted, muscle aches, just achy feeling. She was going to get up and go to work but felt the same symptoms but a little dizzy. Right now, she was feeling a little better but she had this like sinus congestion and the dry cough. She felt bad enough and didn't have enough energy to attend her aunts funeral and was fine yesterday. She also had a little bit of a swollen lymph node. She was not having difficulty breathing or anything like that. She was trying to eat something and its like a little bitty lump in her throat and her lymph node's a little bit tender."" She stated she was starting to feel tired. Stated right now head feels congested almost like sinus pressure. Stated she does not have a headache. Stated that she does not have a temperature. Stated that she feels like crap. Stated that she called the nurse at the hospital and she stated that with the vaccination some people are testing positive for Covid. Stated that she was told that if she was having symptoms that she should go get a Covid test. Wanted to know if she should get a Covid test. Wanted to know if she should get the rapid test or 3 day. Outcome of the events felt like she had the flu/ kind of like flu symptoms, dry cough, arm hurt, tingling going down arm/ tingling down to her fingers, nausea, real tired/ exhausted, muscle aches, just achy feeling, a little dizzy, was recovering. Outcome of the event sinus congestion, feel bad enough, didn't have enough energy, swollen lymph node, its like a little bitty lump in my throat, lymph node's a little bit tender, her head feels congested almost like sinus pressure was unknown. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,,,PVT,,,Medical History/Concurrent Conditions: Migraine,,,"['Asthenia', 'Cough', 'Dizziness', 'Fatigue', 'Influenza like illness', 'Lymph node pain', 'Lymphadenopathy', 'Malaise', 'Myalgia', 'Nausea', 'Pain in extremity', 'Paraesthesia', 'Paranasal sinus discomfort', 'Sensation of foreign body', 'Sinus congestion', 'Upper respiratory tract congestion']",UNK,PFIZER\BIONTECH, 923344,OK,34.0,F,"heart rate (HR) was 180; tongue and lips tingled; walking for a short distance and felt ""off; This is a spontaneous report from a contactable Nurse reported for herself. This 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration on 29Dec2020 15:15 at single dose on left arm for Covid-19 immunisation. Medical history included allergies to hepatitis B vaccine rhbsag (HEY B VACCINE) booster and poison ivy. Concomitant medication included biotin / calcium pantothenate / cyanocobalamin / folic acid / nicotinamide / pyridoxine hydrochloride / riboflavin / thiamine mononitrate (B COMPLEX), fexofenadine, ascorbic acid (VIT C) and Multivitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Immediately after shot (29Dec2020 15:15), her tongue and lips tingled but it went away quickly. She was walking for a short distance and felt ""off."" The patient checked her pulse and pulse ox and her heart rate (HR) was 180. Her HR had bounced around from 150-180 with minimal exertion and was in the 90s at rest. No treatment received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of not recovered. The events were non-serious.; Sender's Comments: A causal association between BNT162B2 and the event heart rate increased cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,B COMPLEX [BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORI; ; VIT C,,Medical History/Concurrent Conditions: Allergy to plants; Poison ivy rash,,,"['Feeling abnormal', 'Heart rate irregular', 'Immediate post-injection reaction', 'Paraesthesia oral']",1,PFIZER\BIONTECH, 923345,NC,50.0,M,"1011-2nd Dose of Pfizer administered; 1025 pt began feeling a quivering in his stomach about where his diaphragm is located. the feeling went away and pt went back to his office. 1045-Symptoms began again flushed/faintness accomapanied the initial quivering. Pt bean feeling tingling his fingers and toes and felt like a lump was in his throat, his neck felt tight. 1052-Reported back to COVID pop up vaccine clinic reporting symptoms to staff in the clinic. 1100-BP 200s/90s HR 110s SPO2 96%. pt interviewed by lead FNP and evaluated. PT given water and granola bar as he reported he did not eat that morning, only took Excedrin. 1115-BP 165/86 HR 92 SPO2 98%RA. pt reports symptoms starting to resolve. 1120-HR 84 SPO2 98%RA. 1122-Pt dc'd to work. pt asked to not leave the hospital for 4-6 hours, not even to work offsite. pt agrees to report to ED if symptoms return.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,None,None,None,Influenza shots for the past 5-6 years have produced a milder version of the symptoms today,None,"['Diaphragmatic spasm', 'Dizziness', 'Flushing', 'Muscle tightness', 'Paraesthesia', 'Sensation of foreign body']",2,PFIZER\BIONTECH,IM 923346,WI,60.0,F,"dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to feel flushed; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 29Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included COVID-19, hypertension and depression. Concomitant medications included vitamins received within 2 weeks of vaccination. The patient previously took duloxetine and experienced allergies. Facility that the most recent COVID-19 vaccine was administered in Workplace clinic. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Dec2020, the patient was dizzy, had fever, elevated blood pressure, and flushed feeling day of vaccine. The next day she continued to feel flushed that moved through her face and down her neck. It felt like she was on fire. The adverse events resulted in the following: Emergency room/department or urgent care. Outcome of the event feel flushed was recovered on 30Dec2020, outcome of other events was recovered in Dec2020. Treatment received for the adverse events included IV fluids, prednisone, diphenhydramine hydrochloride (BENADRYL). Events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events dizzy, fever, elevated blood pressure and flushed feeing cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,,,Medical History/Concurrent Conditions: COVID-19; Depression; Hypertension,,,"['Blood pressure increased', 'Burning sensation', 'Dizziness', 'Flushing', 'Pyrexia']",1,PFIZER\BIONTECH,OT 923347,OK,28.0,F,"swelling/cellulitis in her left arm/redness, inflammation, swelling that looked like cellulitis to the arm/deltoid area; redness; to the arm/deltoid area; inflammation; to the arm/deltoid area; swelling/cellulitis in her left arm/swelling; to the arm/deltoid area; This is a spontaneous report from a contactable nurse reported for herself. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiry date unknown) intramuscular at left deltoid on 16Dec2020 16:45 at single dose for Covid-19 immunization at a hospital facility and not in a military facility. Medical history included ongoing acne. Concomitant medications included ongoing spironolactone for acne. The patient did not receive any other vaccines the day or 4 weeks prior Covid-19 vaccine. The patient informed that after 8 days of getting Covid vaccine she has swelling/cellulitis in her left arm. The patient got the COVID-19 vaccine and had kind of a delayed reaction. She got the vaccine on 16Dec2020 16:45 pm at her workplace. The patient informed that she had no reaction right after the vaccine. On 24Dec2020, the patient experienced redness, inflammation, swelling that looked like cellulitis to the arm/deltoid area. The patient got antibiotics and it has improved. The reporter informed that the events required visit to physician office. The outcome of the events swelling/cellulitis in her left arm/redness, inflammation, swelling that looked like cellulitis to the arm/deltoid area was recovering. The patient was queried regarding seriousness of the events and the patient stated ""it could have potentially dangerous."" The patient wanted to know if she should get second dose of the vaccine.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events vaccination site cellulitis, vaccination site erythema, vaccination site inflammation and vaccination site swelling cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/24/2020,8.0,PVT,,Acne,,,,"['Cellulitis', 'Injection site cellulitis', 'Injection site erythema', 'Injection site inflammation', 'Injection site swelling', 'Peripheral swelling', 'Skin reaction']",1,PFIZER\BIONTECH,OT 923348,MN,50.0,F,. Woke up in the middle of the night with acute facial pain on the left side. From the scalp to the jaw line including the roof of my mouth. I took 3 Advil at the time and the woke again a couple hours later and took 2 more. In the morning it seemed fine. I have noticed a very slight change to my lower left eye - it seems lower.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/02/2021,2.0,WRK,Albuterol,none,asthma,,none,"['Eyelid disorder', 'Facial pain', 'Oral pain', 'Pain in jaw', 'Pain of skin']",1,PFIZER\BIONTECH,SC 923349,HI,,U,"very tired; foggy headed; slight sore injection site; feel very lethargic; hard to focus at work; just want to sleep; This is a spontaneous report from a contactable nurse (patient). An adult patient of an unspecified gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular in the left arm on 29Dec2020 17:45 at a single dose for COVID-19 immunization. The patient's medical history included allergies to bee stings. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took intravenous (IV) magnesium and experienced head to toe rash. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 30Dec2020 07:00, the patient was very tired, a bit foggy headed, slight sore injection site, overall just feel very lethargic/tired. The patient just want to sleep. It was a bit hard to focus at work. No treatment was received for the adverse events. Outcome of the events was unknown. The events were considered non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,UNK,,,Medical History/Concurrent Conditions: Allergic reaction to bee sting,,,"['Disturbance in attention', 'Fatigue', 'Feeling abnormal', 'Lethargy', 'Somnolence', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 923350,,,F,"she had developed symptoms and tested positive to COVID-19; she had developed symptoms and tested positive to COVID-19; This is a spontaneous report from a contactable physician (patient). A female patient of unspecified age received BNT162B2 first dose on 20Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. She tested negative on 18Dec2020. She received the first dose of the COVID 19 vaccine on 20Dec2020. On the following Friday (25Dec2020), she had developed symptoms and tested positive to COVID-19. The outcome of the events was unknown. Information on the batch/lot number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and SARS-CoV-2 test positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/25/2020,5.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 923351,NJ,26.0,F,"received the 1st dose of the COVID-19 vaccine on 21Dec2020, however, on 28Dec2020 she tested positive to COVID-19; received the 1st dose of the COVID-19 vaccine on 21Dec2020, however, on 28Dec2020 she tested positive to COVID-19; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient) from a Pfizer-sponsored Program Pfizer First Connect. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscularly on left deltoid on 21Dec2020 (between 2:15PM and 2:30PM) at single dose (reported as 225mcg/.45ml intramuscular suspension) for COVID-19 immunization. The relevant medical history included birth control. Concomitant medications included ongoing ethinylestradiol, ferrous fumarate, norethisterone acetate (TAYTULLA) for birth control. The patient received the 1st dose of the COVID-19 vaccine on 21Dec2020, however, on 28Dec2020 she tested positive to COVID-19. She wanted to know if the vaccine could have caused a positive test result, if the test assesses IgM or IgG (to the viral spike proteins), could a false positive result be caused by the vaccine. She hadn't been able to get up with her primary care on the phone. This was her first dose. The window to get the second vaccine is 07Jan2021 through 11Jan2021. The patient did not require a visit to emergency room or physician office. The outcome of the events was unknown.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and SARS-CoV-2 test positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/28/2020,7.0,PVT,TAYTULLA,,Medical History/Concurrent Conditions: Birth control,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH,OT 923352,CA,31.0,F,"At about 10 to 12 minutes after she received the vaccine she felt that her throat ""felt numb"" and had trouble swallowing her own saliva. Approximately 30 minutes after the vaccine she noticed significant tongue and oral itching and then hoarseness. Vitals were normal. Did not notice any flushing, rash under skin or swelling. The symptoms all resolved after she received a dose of Benadryl (which she was able to swallow) followed by a dose of Zyrtec. � 3 days after she received her injection she developed sore throat and body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,PVT,Zyrtec as needed,none,allergic rhinitis,influenza,flu vaccine,"['Dysphagia', 'Dysphonia', 'Oral pruritus', 'Oropharyngeal pain', 'Pain', 'Pharyngeal hypoaesthesia', 'Tongue pruritus']",UNK,PFIZER\BIONTECH, 923353,IN,38.0,F,"Eye swelling; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL1284), on 28Dec2020 10:30AM (vaccine location: Left arm) via unknown route of administration at single dose (first dose) for COVID-19 immunization. Medical history and concomitant medications were reported none. There were no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Eye swelling where Allergen filler was placed 7 weeks prior to the event on 30Dec2020 07:00AM. Patient did not receive any treatment. Patient did not have covid prior vaccination. Patient did not have covid tested post vaccination. The outcome of the event was not recovered. This case was assessed non-serious by reporter. The event did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Eye swelling'],1,PFIZER\BIONTECH, 923354,,,M,"acute pericarditis; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on 23Dec2020 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if other vaccines were given in four weeks and unknown if patient had Covid prior vaccination. The patient experienced acute pericarditis on 24Dec2020. Clinical course as follows: Doctor colleagues at the institution admitted (at Emergency room/department or urgent care) and treated a patient with acute pericarditis who received his first dose of Pfizer SARS-CoV-2 EUA vaccine on 23Dec2020. The physician (reporter) considered the event as non-serious. The outcome of the event was recovering. Information about batch/lot number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the event acute pericarditis cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,UNK,,,,,,['Pericarditis'],UNK,PFIZER\BIONTECH, 923355,CA,30.0,F,"received the vaccine last week and tested positive for covid this week; received the vaccine last week and tested positive for covid this week; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), via an unspecified route of administration on 23Dec2020 at single dose by injection in the right arm for COVID-19 immunization (to be protected and to protect her family with other conditions like diabetes). The patient's medical history and concomitant medications were none. The patient got the first dose of the COVID vaccine last week on 23Dec2020 and then she tested positive for COVID on Monday on 28Dec2020. She was asking if it was safe to get the second dose. Patient was a pharmacy technician. The outcome of the events was not recovered. Information on the Lot/Batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and SARS-CoV-2 test positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/28/2020,5.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 923356,MD,30.0,F,"Moderna COVID-19 Vaccine EUA Vaccine recipient stated that a few days after her vaccination she started noticing small mostly flesh colored raised ""bumps"" on both sides of her neck, behind her ears, and on her right cheek. She stated that the rash was not bothersome, but some of the bumps were red. If worsened, she would contact her PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/03/2021,4.0,PVT,,,,,,"['Rash', 'Rash erythematous']",1,MODERNA,IM 923357,OR,35.0,M,"Headache; blurred vision; unable to read at time; Difficulty focusing; right hand numbness; This is a spontaneous report from a contactable Nurse (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 04:15 PM, Intramuscularly at single dose (Vaccine location: Left arm) for COVID-19 immunization. Medical history was reported none. Concomitant medications were not reported. Patient did not have any allergies. Patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient experienced Headache, blurred vision and unable to read at time, Difficulty focusing and right hand numbness on 30Dec2020 12:00 AM. Patient did not receive any treatment. The outcome of the events was not recovered. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. Information on the lot/ batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events headache, vision blurred, cognitive disorder, disturbance in attention and hypoaesthesia cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Disturbance in attention', 'Headache', 'Hypoaesthesia', 'Vision blurred']",UNK,PFIZER\BIONTECH,OT 923358,PA,,U,"Nausea; Diarrhea; All over weakness; I have 100.4�F temp; Vomiting projectile; Body aches and pains; shortness of breath; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL0140), via an unspecified route of administration at single dose on 29Dec2020 06:30 at the hospital for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Dec2020, after receiving vaccine, the patient experienced nausea, diarrhea, all over weakness, I have 100.4�F temp, vomiting projectile, body aches and pains, shortness of breath. The outcome of the events was unknown. The patient stated: ""I didn't have any of the symptoms until I got the vaccine, the nausea is a big issue for because I have connected tissue disease and I have to take my medication today. I take Cellcept and Prednisone, every day and I am hoping to get them. I just need to get it in.""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/01/2020,,PVT,,,,,,"['Asthenia', 'Body temperature', 'Diarrhoea', 'Dyspnoea', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting projectile']",UNK,PFIZER\BIONTECH, 923359,MO,38.0,F,"around 1:00 a.m. I awoke with stomach pain and had diarrhea. I continued to have stomach pains and had diarrhea again around 2-3:00a.m. Stomach pain continued. At approximately 4:00 a.m. I vomited. I continued to have stomach pain, back pain, vomiting and diarrhea. I vomited every hour from 4:00 a.m. to 10:00 a.m. whether or not I consumed any liquids. At approximately 10:45a.m. I took an anti-nausea medication proscribed by a healthcare provider and the vomiting ceased. I continued to have stomach and back pains for the remainder of the day. I felt better the following day, but still had back pain/soreness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/02/2021,3.0,PVT,"Synthroid/Levothyroxine, Pre-natal vitamin, vitamin B complex, Aurobindo",occasional diarrhea,Hashimotos disease,Pertussis vaccine,"penicillin, sulpha drugs, pertussis vaccine (cir. 1983), bee stings","['Abdominal pain upper', 'Back pain', 'Diarrhoea', 'Vomiting']",1,MODERNA, 923360,OH,57.0,F,"post nasal drip; cough; Hoarse voice; This is a spontaneous report from a contactable nurse (reporting for herself). A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EK5730, expiry date not reported), intramuscular in 29Dec2020 12:00 at a single dose in the left arm as Covid vaccine. Medical history included diagnosis is hypothyroidism, and patient have had reaction to almost all medications, wherein PCP (primary care provider) thinks patient have a reaction to the coating on tablets and to capsules. Patient had no covid prior vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. About 20 minutes after receiving on 29Dec2020 12:00, started with post nasal drip, which caused a cough; hoarse voice. These symptoms lasted about 2 hours. Since they are not listed as side effects just wanted to share. Patient did have a negative covid test on the day of the vaccine (covid tested post vaccination on 29Dec2020). No treatments received for the events reported. The events were reported as not serious (not resulting in death, not life threatening, did no caused/ prolonged hospitalization, not disabling/Incapacitating, not congenital anomaly/birth defect). The outcome of the events post nasal drip, cough and hoarse voice was recovered on 29Dec2020 14:20.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Drug allergy (thinks I have a reaction to the coating on tablets and to capsules.); Hypothyroidism (Only diagnosis is hypothyroidism),,,"['Cough', 'Dysphonia', 'SARS-CoV-2 test', 'Upper-airway cough syndrome']",1,PFIZER\BIONTECH,OT 923361,MI,49.0,F,"Hives, started in R Groin, traveled to R axila, back, neck, arms, leg and trunk; severe palm itching, severe feet itching; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), via an unspecified route of administration on 22Dec2020 16:00 at single dose at left arm for COVID-19 immunization. Medical history included allergies Ct contrast. The patient's concomitant medications were not reported. ON 23Dec2020 04:00, 12 hours post injection- the patient experienced Hives, started in R Groin, traveled to R axila, back, neck, arms, leg and trunk. 24 hours after the first incident, the patient experienced severe palm itching, another 24 hours later, the patient then experienced severe feet itching. The AE resulted in emergency room/department care. The patient received treatment for the events (Solumedrol). The events was assessed as non-serious. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Contrast media allergy (known allergies Ct contrast),,,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH, 923362,ID,59.0,F,Sore arm and flu like symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Influenza like illness', 'Limb discomfort']",1,MODERNA,IM 923363,GU,,F,"hard time breathing; This is a spontaneous report from a contactable consumer (patient's daughter-in-law). This consumer reported for two patients. This is the second of two reports. A 92-year-old female patient received single dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 29Dec2020 for immunisation. The patient's medical history and concomitant medications were not reported. The patient took the vaccine the day before reporting (29Dec2020). The patient had a ""hard time breathing"" at the start but was resolved now (Dec2020). The reporter was asking for recommendations.The event was considered as non-serious by the reporter. Information about Lot/batch no has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520754 same reporter/drug, different patient/event",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/01/2020,,UNK,,,,,,['Dyspnoea'],UNK,PFIZER\BIONTECH, 923364,,,F,"She though she received the vaccine either intradermally or subcutaneously, because she noticed a red bump on her arm; She though she received the vaccine either intradermally or subcutaneously, because she noticed a red bump on her arm; I have not received the vaccine intramuscularly; I have not received the vaccine intramuscularly; This is a spontaneous report from a contactable pharmacist (patient). A female patient of an unspecified received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 29Dec2020 for immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Covid-19 Vaccine the day before reporting (29Dec2020) from work. She has not received the vaccine intramuscularly; the needle was a half inch. She thought she received the vaccine either intradermally or subcutaneously, because she noticed a red bump on her arm (onset date: 29Dec2020). Patient asked if the vaccine can be administered by an alternative route other than intramuscular. She wanted to know if she should restart the vaccination series as she received the first dose of Covid-19 vaccine by the wrong route. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,UNK,,,,,,"['Off label use', 'Product use issue', 'Vaccination site erythema', 'Vaccination site mass']",UNK,PFIZER\BIONTECH, 923365,NY,54.0,M,Fever of 101.6,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,SEN,none,,,,Allergic to Penicillin,['Pyrexia'],1,PFIZER\BIONTECH,IM 923366,PA,50.0,F,"Low grade temp 99.6, chills, tired, headache; Low grade temp 99.6, chills, tired, headache; Low grade temp 99.6, chills, tired, headache; Low grade temp 99.6, chills, tired, headache; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female received first single dose of BNT162B2, (Pfizer, Solution for injection, Lot number: EK 9231, exp date not reported), intramuscular (anatomical location: arm left) on 29Dec2020 09:15 for immunization. Medical history included asthma, hypothyroid, high cholesterol, and allergies: latex and shellfish. The patient was diagnosed with COVID-19 Prior to vaccination.Concomitant medication (Other medications in two weeks) include: magnesium sulfate, ibuprofen, cetirizine hydrochloride (ZYRTEC ALLERGY), levothyroxine sodium (SYNTHROID), montelukast sodium (SINGULAIR), simvastatin, and cimicifuga racemosa root, glycine max extract (BLACK COHOSH & SOY ISOFLAVONES). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility type vaccine: Hospital. The patient experienced low grade temp 99.6, chills, was tired, and headache on 29Dec2020 19:00. No treatment was received. Patient was not Covid tested post vaccination. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,; ; ZYRTEC ALLERGY; SYNTHROID; SINGULAIR; ; BLACK COHOSH & SOY ISOFLAVONES,,Medical History/Concurrent Conditions: Asthma; COVID-19; High cholesterol; Hypothyroidism; Latex allergy; Shellfish allergy,,,"['Body temperature', 'Chills', 'Fatigue', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH,OT 923367,VA,58.0,F,"Both Legs Became Completely Numb; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular in the right arm on 28Dec2020 07:45 at a single dose for COVID-19 immunization. The patient's medical history included diabetes and blood pressure (BP) abnormal. The patient was not pregnant. Concomitant medications included losartan potassium (LOSATAN), metformin, and amlodipine besilate (NORVAC), clopidogrel bisulfate (PLAVIX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took codeine and experienced allergies to codeine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 29Dec2020 19:00, the patient was sitting and both of her legs became completely numb for 20 minutes and then the symptoms went away. This never happen before. No treatment was received for the adverse event. Outcome of the event was recovered on 29Dec2020 19:20. The event was considered non-serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,LOSATAN; ; NORVAC; PLAVIX,,Medical History/Concurrent Conditions: Blood pressure abnormal; Diabetes,,,['Hypoaesthesia'],1,PFIZER\BIONTECH,OT 923368,AK,66.0,F,SORE ARM,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,"VIT C, B12,D3",,,,NONE,['Pain in extremity'],1,PFIZER\BIONTECH,IM 923369,PA,55.0,M,"Severe Headache; muscle pain (neck and left shoulder); muscle pain (neck and left shoulder); joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), via an unspecified route of administration in the left arm on 30Dec2020 12:45 at a single dose for COVID-19 immunization. The patient's medical history included diabetes, hypothyroidism, hypercholesterolemia, and obesity. Concomitant medication included metformin hydrochloride (GLUCOPHAGE), metformin, semaglutide (OZEMPIC), fluoxetine hydrochloride (PROZAC), levothyroxine sodium (SYNTHROID). The patient previously took varenicline tartrate (CHANTIX) and experienced nightmare and allergies to varenicline tartrate. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 30Dec2020 13:30, the patient experienced severe headache, muscle pain (neck and left shoulder), and joint pain. No treatment was received for the adverse event. Outcome of the event was recovered on Dec2020. The events were considered non-serious. The following information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,GLUCOPHAGE [METFORMIN HYDROCHLORIDE]; ; OZEMPIC; PROZAC; SYNTHROID,,Medical History/Concurrent Conditions: Diabetes; Hypercholesterolemia; Hypothyroidism; Obesity,,,"['Arthralgia', 'Headache', 'Myalgia', 'Neck pain']",1,PFIZER\BIONTECH, 923370,,,F,"high heart rate; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced high heart rate on an unspecified date. Outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Heart rate', 'Heart rate increased']",UNK,PFIZER\BIONTECH, 923371,FL,45.0,F,"Fever, arm pain, diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,Asa,No,SLE with nephritis,,"Sulfa, tetracycline and compazine","['Diarrhoea', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 923372,FL,41.0,F,"vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated (size of tennis ball); vaccine site rt deltoid began to itch and had red blotches; vaccine site rt deltoid began to itch and had red blotches; Headache; low grade fever; sore throat; This is a spontaneous report from contactable healthcare professional . A 41-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at a right deltoid on 16Dec2020 11:00 at a single dose for COVID-19 immunization, at a hospital. Medical history included seasonal allergy. No known allergies to medication, food or other products. The patient's concomitant medications were not reported. On 19Dec2020 16:00, day 3 post vaccine, the patient experienced headache, low grade fever, and sore throat. On 27Dec2020, day 11, patient experienced vaccine site right (rt) deltoid began to itch and had red blotches. On 28Dec2020, day 12, the patient experienced vaccine site was pink, warm, indurated (size of tennis ball). Treated with paracetamol (TYLENOL), topical/oral diphenhydramine (BENADRYL) and topical 1% hydrocortisone. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any medications within 2 weeks of vaccination. The patient was tested for COVID-19 with via rapid test and PCR with nasal swab, both negative on 22Dec2020. The patient recovered from the events, headache, low grade fever, and sore throat on 24Dec2020, day 8 post vaccine and the rest of the events on 30Dec2020, day 14. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/19/2020,3.0,PVT,,,Medical History/Concurrent Conditions: Seasonal allergy,,,"['Headache', 'Laboratory test', 'Oropharyngeal pain', 'Polymerase chain reaction', 'Pyrexia', 'Vaccination site erythema', 'Vaccination site induration', 'Vaccination site pruritus', 'Vaccination site rash', 'Vaccination site warmth']",1,PFIZER\BIONTECH, 923373,CA,33.0,F,"Hives to opposite arm; redness to injection site; Itching; This is a spontaneous report from a contactable pharmacist. A 33-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EJ1685, expiry date not reported), intramuscular in 30Dec2020 09:00 at a single dose in the left arm as COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient had no known allergies. The patient had no allergies to medications, food, or other products. The patient had no COVID prior vaccination and patient was not tested for COVID post vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 09:15, the patient experienced hives to opposite arm and redness to injection site, and itching. Started within 20 minutes, patient taken to the emergency room/department or urgent care for evaluation and medications. As treatment, patient received diphenhydramine, famotidine, prednisone in response to the events reported. The events reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect. The outcome of the events hives to opposite arm and redness to injection site, and itching was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Pruritus', 'Urticaria', 'Vaccination site erythema']",1,PFIZER\BIONTECH,OT 923375,NJ,31.0,F,"Dizzy; Nausea; she broke out with what felt like a million bugs on her head and face, states it is burning and itching/burning and itching on face and head during hair appointment; felt bad/did not feel right all day; she broke out with what felt like a million bugs on her head and face, states it is burning and itching/burning and itching on face and head during hair appointment; there is a lot of paranoia; This is a spontaneous report received from a contactable consumer (who is also the patient). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration, on 28Dec2020, at single dose, for COVID-19 immunization. There were no medical history and concomitant medications. The patient stated she got the first dose of the Pfizer Covid vaccine on Monday, 28Dec2020. She mentioned that she read the list of side effects and all the print outs and stated her events were not on there. She wanted to make sure and stated maybe it was not even from the vaccine. She reported she just came from the hair dresser, had hair colored before many times, but today (30Dec2020), when she put the dye on her hair, she broke out with what felt like a million bugs on her head and face, stated it is burning and itching, maybe it is her imagination. She knows there is a lot of paranoia. She reported that she has had hair colored before and this has never happened, it occurred during hair coloring treatment. She also mentioned that on 30Dec2020 (also reported as ""yesterday"", pending clarification), she felt dizzy and nauseous; on 29Dec2020 (reported as ""yesterday""), she felt bad and did not feel right all day, but says she knows those were listed symptoms. The outcome of the events dizziness, nausea, burning sensation and pruritus was recovering; the outcome of events paranoia and feeling abnormal was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/01/2020,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Burning sensation', 'Dizziness', 'Feeling abnormal', 'Nausea', 'Paranoia', 'Pruritus']",1,PFIZER\BIONTECH, 923376,WV,22.0,F,"Patient received the Moderna COVID19 vaccine on 12/28/2020 approximately 10:00 AM. By approximately 1830 patient noticed she was beginning to have some peripheral vision disturbances. Patient noted to have slight head ache at the time. Two mornings, on Wednesday, patient reports being unable to see when entering a lighted room. Vision limitations being able to see minimally and what was able to be seen was very blurry with dark circles when squinting. This visual disturbance improved after 30 seconds to a few minutes of being in dim light. This occurred on Wednesday with headache developing later in the day. Ibuprofen helped headache. Has continued to have daily headaches since injection. Patient states headaches seem to be improving some as the week has gone on.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Nexplonon birth control,None noted,None noted,,None noted,"['Blood thyroid stimulating hormone', 'Full blood count', 'Headache', 'Metabolic function test', 'Photophobia', 'Vision blurred', 'Visual field defect', 'Visual impairment']",1,MODERNA,IM 923377,,39.0,F,"extreme soreness at injection site; GI upset; sleeplessness; mild fever; pain radiating down left arm and up to behind left ear; pain radiating down left arm and up to behind left ear; neck tightness; mild headache; This is a spontaneous report from a non-contactable Nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at left arm on 29Dec2020 10:30 at single dose for Covid-19 immunization in a hospital facility. Medical history included hypothyroid, PCOS (polycystic ovarian syndrome), sulfa allergies. Concomitant medications included unknown medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 29Dec2020 13:00, the patient experienced extreme soreness at injection site, GI upset, sleeplessness, mild fever, pain radiating down left arm and up to behind left ear, neck tightness, mild headache. The patient has not been tested for Covid-19 since the vaccination. The patient did not receive treatment for the events. The outcome of the events extreme soreness at injection site, GI upset, sleeplessness, mild fever, pain radiating down left arm and up to behind left ear, neck tightness, mild head ache was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. No follow-up attempts are possible, information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Hypothyroidism; Polycystic ovarian syndrome; Sulfonamide allergy,,,"['Abdominal discomfort', 'Ear pain', 'Headache', 'Insomnia', 'Muscle tightness', 'Pain in extremity', 'Pyrexia', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 923378,OK,46.0,F,"now 2 hours later I have a rash on my belly; Metallic taste almost immediately; This is a spontaneous report from a contactable other healthcare professional (hcp). A 46-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231, expiry date not reported), via an unspecified route of administration on 30Dec020 16:45 at a single dose in the left arm as Covid vaccine. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient previously took iodine and experienced allergies. The patient was not in other vaccine in four weeks. The patient had no prior COVID vaccination and was not tested for COVID post vaccination. The patient experienced metallic taste almost immediately (30Dec2020 16:45) and now 2 hours (18:45) later patient have a rash on the belly. No treatments received in response to the events reported. The events reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect. The events metallic taste and rash on the belly was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Dysgeusia', 'Rash']",1,PFIZER\BIONTECH, 923379,,,F,"mild rash; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration in Dec2020 at a single dose for Covid-19 Vaccine. The patient's medical history and concomitant medications were not reported. Patient just had her covid vaccine shot a week ago (Dec2020) and was experiencing mild rash. Patient was asking if she was contagious. The outcome of the event mild rash was unknown. Lot/Batch and Expiration date has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,['Rash'],UNK,PFIZER\BIONTECH, 923380,GA,36.0,F,"""About 2 hours after vaccine administration experienced severe fatigue. Went home and took 2 hour nap. Was still somewhat fatigued through the evening. Felt fine when waking up the next day.""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Fatigue'],1,PFIZER\BIONTECH,IM 923381,MA,21.0,F,"Arm soreness; stuffy nose/congestion; tired; knee pain; This is a spontaneous report from a contactable nurse (patient). A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on the left arm on 29Dec2020 12:30 at single dose for covid-19 immunisation. Medical history included tree fruit allergy. Concomitant medication included paracetamol (TYLENOL) and ibuprofen (ADVIL). The patient previously took cefaclor (CECLOR) and experienced drug allergy. The patient experienced arm soreness, stuffy nose/congestion, tired and knee pain on 29Dec2020 17:30. The patient did not receive treatment for the reported events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: pending on 29Dec2020. Outcome of events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,TYLENOL; ADVIL [IBUPROFEN],,Medical History/Concurrent Conditions: Fruit allergy,,,"['Arthralgia', 'Fatigue', 'Nasal congestion', 'Pain in extremity', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 923382,HI,61.0,F,"pain in arm at injection site; This is a spontaneous report from a contactable other healthcare professional (hcp). A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1284, expiry date not given), intramuscular on 29Dec2020 18:00 at a single dose in the left arm as Covid Vaccine. Medical history included hypothyroid, low adrenal cortex and allergies to sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of the vaccination. Concomitant medication included fluoxetine. The patient had no vaccine in four weeks. The patient previously took amoxycillin and experienced allergies. On 29Dec2020 (reported as at 5:30 AM and 5:00 AM; pending clarification), the patient experienced pain in arm at injection site. Since the vaccination, the patient has not been tested for COVID-19. The event reported was not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect. The outcome of the event pain in arm at injection site was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Hypothyroidism; Insufficiency adrenal cortex; Sulfonamide allergy,,,['Vaccination site pain'],1,PFIZER\BIONTECH,OT 923383,IL,33.0,M,"Within 1 hour, increasing dizziness and vertigo like symptoms, loss of appetite, followed by fatigue weakness and febrile episodes by 10pm that evening. These persisted until 0300AM on the 19th.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,None,None,None,,None,"['Asthenia', 'Decreased appetite', 'Dizziness', 'Fatigue', 'Pyrexia', 'Vertigo']",1,PFIZER\BIONTECH,IM 923384,NY,41.0,F,"mild supraglottic swelling of my aryepiglottic folds; feel difficulty swallowing (globus); allergic response; This is a spontaneous report from a contactable physician. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 23Dec2020 12:30 at single dose for COVID-19 immunisation. Medical history included allergies to medications, food, or other products: Penicillin. There were no concomitant medications. The patient previously took benzoyl peroxide and experienced allergies. The patient experienced stated that on 23Dec2020 12:31, ""I am an ENT surgeon. I received the first dose of the vaccine at 12:30pm. Within 1-2 minutes I started to feel difficulty swallowing (globus). I reported this to the nurse and she offered me ginger ale. My symptoms worsened and then stabilized after 10 minutes. I went upstairs and got the residents to perform a fiberoptic nasoendoscopy and this demonstrated mild supraglottic swelling of my aryepiglottic folds. I choose not to receive treatment as I did not want to dampen my allergic response and as an ENT surgeon manage airways on a daily basis. I stayed at the hospital for a further 6 hours and continued to work. My symptoms resolved after 9 hours"". The outcome of the events was recovered on 23Dec2020.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event laryngeal oedema cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Dysphagia', 'Hypersensitivity', 'Laryngeal oedema', 'Nasoendoscopy']",1,PFIZER\BIONTECH,OT 923385,AR,35.0,F,"chronic auto immune response; angioedema/tongue is swollen; urticaria/hives; This is a spontaneous report from a contactable other healthcare professional. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), intramuscular in the right arm on 28Dec2020 10:15 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC), omeprazole (PROTONIX), naproxen sodium (ALEVE), and birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 30Dec2020 16:00, the patient have a chronic auto immune response in the form of urticaria and angioedema. The symptoms of hives as well as swollen tongue was maintained with antihistamines. Outcome of the events was not recovered. The events were considered non-serious. The following information on the batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the events chronic autoimmune response in the form of urticaria and angioedema with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PROTONIX [OMEPRAZOLE]; ALEVE,,,,,"['Angioedema', 'Autoimmune disorder', 'Chronic spontaneous urticaria', 'Swollen tongue', 'Urticaria']",UNK,PFIZER\BIONTECH,OT 923387,,68.0,F,"bit achy and she can definitely tell where the injection was administered; This is a spontaneous report from contactable consumer. A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration, at the left shoulder on 29Dec2020 around 3:00-4:00pm at single dose for immunisation . Medical history included ongoing Sjogren'ssyndrome, Raynaud's disease, antiphospholipid antibody syndrome, two other conditions which the patient cannot remember, was on blood thinner, immunocompromised or on medication that compromises your immune system-all of which apply to her. Concomitant medication included hydroxychloroquine (PLAQUENIL), warfarin, aspirin all from about 15-20 years ago as a blood thinner. On 29Dec2020, patient felt like the vaccine has affected her a bit as she was feeling a bit achy and she can definitely tell where the injection was administered because sometime last night she rolled over and thought well she won't be sleeping on that left arm after getting the vaccine injection in her left shoulder. She was not sure if her feeling a bit achy is just the day, or related to the vaccine. Patient did not read the product paperwork until last night when she got home after having been administered the vaccine. She was given an approximate date of her second scheduled dose around 19Jan2021; that is not necessarily the date she will get the second dose; that depends on the next clinic date at the county health department. No plan to change dose unless advised to. The patient has not yet recovered from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,UNK,PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; ; ASPIRIN [ACETYLSALICYLIC ACID],Antiphospholipid syndrome; Raynaud's disease; Sjogren's,Medical History/Concurrent Conditions: Clotting disorder; Immunocompromised,,,['Vaccination site pain'],UNK,PFIZER\BIONTECH, 923388,NY,72.0,F,"she just feels very weak now; room spinning; got very dizzy; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date not reported), via an unspecified route of administration on 29Dec2020 09:00 at a single dose in the left arm as COVID-19 vaccine. Medical history included blood pressure high (diagnosed a while ago at the time of the report), and she has been taking a medication for it for years. There were no concomitant medications. Patient said she had no new medications or other vaccinations administered with this vaccine. On 29Dec2020 22:00, he patient had a reaction where the room was spinning and she got very dizzy. She would like to know is that normal, since she has to go back for a second shot. She was given the vaccine by a nurse at the hospital she works as technician at which is not a military hospital. She said that the hospital is giving the vaccine to its employees. She got the vaccine yesterday morning around or after 09:00AM, and she was ok during the day. She said that the room spinning started before she went to bed at about 10:00PM, and when she got to her room she noticed everything was moving around. She said then she fell asleep, and it was better today, the room was not moving, she just felt very weak now (30Dec2020). Patient said as her treatment for room was spinning and she got very dizzy was that she fell asleep. The events room was spinning and she got very dizzy were recovering. The outcome of the event felt very weak was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure high (she has been taking a medication for it for years),,,"['Asthenia', 'Dizziness', 'Vertigo']",1,PFIZER\BIONTECH, 923389,,,F,"Heart palpitations; Fatigue; Severe stomach cramping; High blood pressure; Cough; This is a spontaneous report from a contactable other HCP (patient). This female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at single dose (lot number: EK5730) for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient said she had a list of reported side effects that she was having from the COVID Vaccine. The patient received COVID-19 vaccine on 23Dec2020 (not clarified), and since then she had been having symptoms. She had been to the doctor about it and she was currently going to treatment for it. But she had been experiencing heart palpitations, fatigue, severe stomach cramping, high blood pressure and cough. That was all she got. Outcome of all events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,,,UNK,,,,,,"['Abdominal pain upper', 'Blood pressure measurement', 'Cough', 'Fatigue', 'Hypertension', 'Palpitations']",UNK,PFIZER\BIONTECH, 923390,OH,44.0,F,"Moderate difficulty breathing for about 36 hours, relieved somewhat by Albuterol Inhaler.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,None,None,None,,None,['Dyspnoea'],1,PFIZER\BIONTECH,IM 923391,PA,40.0,F,"Burning when the medication was injected; Injection was given under the shoulder bone instead of the deltoid muscle; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional (patient) reported that a 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration under the shoulder bone (arm), on 30Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included use of multivitamin for a healthy lifestyle. The patient's concomitant medication included ongoing unspecified multivitamin. The patient received the COVID-19 vaccine this morning (30Dec2020) as she works in a COVID unit. The injector put it under her shoulder bone and not in the deltoid muscle; injection was given under the shoulder bone instead of the deltoid muscle. The patient complained of it burning - started when the medication was injected. The patient also asked if this was good enough and if it will it be effective. The patient was recovering from the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Routine health maintenance,,,"['Product administered at inappropriate site', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 923392,,,F,"Having ringing in her ear today; This is a spontaneous report from a contactable consumer. A female patient (Age: 67; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had ringing in her ear on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Tinnitus'],UNK,PFIZER\BIONTECH, 923394,CA,38.0,F,Patient describes tachycardia starting on day 4 following the vaccination. Required emergency room visit along with primary care and cardiology evaluation. Currently undergoing holter monitor study. As of 1/6/2021 patient clinical status improving.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/24/2020,4.0,PVT,Vitamin C,None,None,,None,"['Blood thyroid stimulating hormone', 'Cardiovascular evaluation', 'Electrocardiogram', 'Electrocardiogram ambulatory', 'Full blood count', 'Physical examination', 'Tachycardia', 'Thyroxine']",1,PFIZER\BIONTECH,IM 923395,TN,50.0,F,"Tachycardia/her heart rate at 11:00PM last night was at around 100/ she checked her pulse it was 115; she was not feeling right, so she took the day off from work today; Lightheadedness; wobbly; she felt weak; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284, expiration date: Apr2021), via an unspecified route of administration at right deltoid on 29Dec2020 17:45 at a single dose for Covid-19 immunization. Medical history included asthma from 2003 and ongoing, tachycardia and major surgery. Concomitant medication included maintenance inhaler (unspecified) for asthma. Patient was officially diagnosed with asthma in 2003. She said her asthma was controlled, and she takes a maintenance inhaler every day. She said she has been taking the same maintenance inhaler since she was first diagnosed with the asthma. She said she rarely uses a rescue inhaler. Reported she was prescribed the Metoprolol Tartrate 25mg for her tachycardia that she had after her major surgery, but she did not take the full 25mg dose during that time. She said she hasn't had taken the Metoprolol Tartrate 25mg in almost a year, clarifying it was last Jan2020 that she used the Metoprolol Tartrate. The patient previously received a flu shot in Oct2020, and felt rundown for a day afterwards, but that she always does after she receives a flu shot. She said she had no heart issues after receiving the flu shot in Oct2020. The patient who is a registered nurse reported she received the COVID-19 vaccine last night at work, on 29Dec2020, at 5:45PM, and had experienced some tachycardia after receiving the vaccine. Reported the COVID-19 Vaccine was offered through her employer. She said the COVID-19 vaccine was optional and offered to all employees if they work at the hospital. She experienced the tachycardia at 11:00 PM last night, 29Dec2020. She said her normal resting heart rate is between the high 60s to low 70s. She said her heart rate at 11:00PM last night was at around 100, clarifying she was not running a fever at that time. She stated after she received the COVID-19 vaccine, she was not feeling right, so she took the day off from work today, and slept in. She said when she woke up this morning (in Dec2020), she still didn't feel right, saying she felt weak and wobbly, and when she checked her pulse it was 115. She said she does have a past history of tachycardia. She said a year ago she had major surgery, and she had tachycardia after the major surgery. She said the tachycardia eventually went away, but she did have to see a cardiologist and take a beta blocker. She said she took a tiny dose of the beta blocker this morning, and called the cardiologist to let him know what was going on. She said she has not heard back from the cardiologist yet. She said the tachycardia went away once she took the beta blocker this morning. She said she took the beta blocker because her heart rate was going higher, and higher. She said she didn't want to end up like last year after her major surgery with a heart rate in the 170s. She said the tachycardia she was experiencing after receiving the COVID-19 Vaccine was not normal for her. She said once she got over the major surgery last year, her heart rate was fine. Reported her employer was making employees wait around for 15 minutes after the employees received the COVID-19 Vaccine to make sure no one had a major reaction to the COVID-19 Vaccine. She said after she received the COVID-19 Vaccine, she waited around longer than the 15 minutes. She said she felt weird after she received the COVID-19 Vaccine and thought maybe she was experiencing anxiety. She said she was lightheaded on 29Dec2020 after she received the COVID-19 Vaccine and completed a report right then on the website. She said the website is for reporting adverse events, and she was sent a website link to complete the adverse event reporting. She said she signed into the website link while she was still at the hospital. She said one of the website's first questions asked was how she was feeling. She said the question made her wonder if her lightheadedness was due to her heart rate being up because she becomes lightheaded when that happens. She clarified she reported only the lightheadedness on the website, and not the tachycardia. She said her lightheadedness got better and she was fine, and then at 11:00PM the tachycardia hit her like a switch. Reported this morning she felt fine, and then all of sudden she wasn't fine. Tachycardia Treatment: Reported she took a 8.5mg dose, or one quarter of a 25mg tablet (as provided by the reporter) of the beta blocker Metoprolol Tartrate 25mg tablet this morning and called her cardiologist to let him know. She said she split the Metoprolol Tartrate 25mg tablet this morning, and only took a quarter of the 25mg tablet (reported as a 8.5mg dose by the reporter). Reported she believes 100% that her tachycardia was caused by the COVID-19 Vaccine, saying she has been fine up until receiving the COVID-19 Vaccine. She said she got the COVID-19 Vaccine because she was afraid of getting the COVID-19 Virus with her asthma. She said she has no other preexisting conditions besides the asthma. Reported she is not going to get the second COVID-19 Vaccine dose. She said it was scary when her heart rate shot up out of nowhere. She said the COVID-19 Vaccine is the only thing different she has done. She said before the COVID-19 Vaccine, she was completely fine. Patient asked if the Pfizer DSU agent had heard of anyone else who has experienced tachycardia after receiving the COVID-19 Vaccine. The outcome of the event tachycardia was recovered in Dec2020, event lightheadedness was recovering and unknown for the other events. The reporter assessed the event 'tachycardia' as Serious (Medically Significant).; Sender's Comments: Based on the close temporal relationship, the association between the event tachycardia with BNT162b2 can not be fully excluded. The medical history of tachycardia and asthma medication may be contributory as well. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/01/2020,,PVT,,Asthma,Medical History/Concurrent Conditions: Surgery; Tachycardia,,,"['Asthenia', 'Balance disorder', 'Condition aggravated', 'Dizziness', 'Feeling abnormal', 'Heart rate increased', 'Impaired work ability', 'Tachycardia']",UNK,PFIZER\BIONTECH, 923396,MN,42.0,F,"she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from the time she got home, all night. and part of day today; this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose; running a fever; Fatigue/she is tired again; very weak; nauseated; Headache; Her throat didn't feel right; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at half dose, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. It was reported that the patient previously received INFLUENZA VACCINE for immunization but she gets nauseated and tired. On 29Dec2020, she was very weak, nauseated, had a headache, fatigue and her throat didn't feel right. On 30Dec2020, she was running a fever, it was 100.5 (units unspecified). It was also reported that she could barely walk; further reported as couldn't walk hardly, she was still feeling ""cruddy"" and she just doesn't feel good at all. The patient reportedly slept from the time she got home, all night and part of day today. After she rests for a while, once she gets up, she is tired again. It was also reported that the patient was told that this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose. She will receive her second dose on 19Jan2021. Outcome of the events ""very weak"" and ""fatigue/she is tired again"" was recovering; outcome of events ""nauseated"", ""headache"", ""her throat didn't feel right"" and ""running a fever"" was not recovered; outcome of the events ""could barely walk/couldn't walk hardly"", ""feeling cruddy/doesn't feel good at all"" and ""slept from the time she got home, all night and part of day today"" was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,UNK,,,,,,"['Asthenia', 'Body temperature', 'Fatigue', 'Gait disturbance', 'Headache', 'Malaise', 'Nausea', 'Oropharyngeal discomfort', 'Pyrexia', 'Somnolence', 'Underdose']",1,PFIZER\BIONTECH, 923397,CO,62.0,M,"pt reported a swallowing arm at the site of injection, recommended to use Benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PHM,,,,,,['Injection site swelling'],1,PFIZER\BIONTECH,IM 923398,ND,62.0,F,"swelling and joint pain in the little finger on left arm; swelling and joint pain in the little finger on left arm; She got a bruise at the injection site; It bled a little bit when she put it in; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231), via an unspecified route of administration on the left arm, on 28Dec2020 at 14:15 at a single dose for Covid-19 immunization. Medical history included environmental allergies, she has allergies and can have an asthmatic attack from cat dander and perfume, blood pressure (abnormal) and sleep (disorder). Concomitant medications included ongoing lisinopril for blood pressure, colecalciferol (VITAMIN D), acetylsalicylic acid (BABY ASPIRIN), paracetamol (TYLENOL). The patient previously took novocaine but was allergic. She got all this information when she got the vaccine on Monday at (place name) in (state name). It tells all the side effects from the first injection. She wanted to report that it is the same arm that she got the vaccine in. She has swelling and joint pain in the little finger on left arm. It says you can have joint pain, but nothing about swelling. She thought she better report it. This was her first shot. She is supposed to get the second one on 18Jan2021. She wanted to make sure she can take it. She received the vaccine on 28Dec2020. She laid around that day. Today is the first day she doesn't have arm pain and swelling at the injection site. It was the first time she has had arm pain. She has never had that with flu shot. The arm pain started within the 15 minutes she was observed. It hurt like hell until that day. She got a bruise at the injection site. It bled a little bit when she put it in. Swelling and joint pain in the little finger on left arm: she doesn't know if it was later that day. She can't remember. She really noticed it yesterday. She has never had joint pain or swelling. She doesn't have any problems with arthritis. Now her little finger is bigger than the rest of her fingers. It hurts because of the swelling. She doesn't want to take anything. It might be fluid. She has a high pain tolerance. She keeps bending it thinking it will get better. It isn't as bad, but its still swelled up. At first she thought it was better, but it is still pretty swollen. To her this is a reaction. She was thinking if she took paracetamol before, it wouldn't hurt as bad, but she can't remember if she took it that morning. She takes 500mg before bed for the heck of it at night. It helps her sleep better. She has allergies and can have an asthmatic attack from cat dander and perfume. They think she was allergic to the preservative in the flu shot, but she has never had any trouble with the flu shot since. She has environmental allergies. They thought she was allergic to Novocaine once at the dentist office. Who knows, it only happened once. She's been to the dentist many times and who knows what they injected and why she reacted that way. She felt like she was going to pass out. They don't give it to her anymore. She doesn't know what was in it. She is worried since this vaccine is emergency authorization. She doesn't want to get the next one and have a worse reaction. She is not sure if she should be worried. The events of swelling and joint pain in the little finger on left arm were assessed as medically significant. Outcome of the event of 'swelling of fingers' was not recovered, the other events were unknown.; Sender's Comments: There is a reasonable possibility that the event joint pain was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the event swelling with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,,,PVT,; VITAMIN D [COLECALCIFEROL]; TYLENOL,Allergy (she has allergies and can have an asthmatic attack from cat dander and perfume),Medical History/Concurrent Conditions: Blood pressure abnormal; Environmental allergy; Sleep disorder,,,"['Anxiety', 'Arthralgia', 'Injection site bruising', 'Injection site haemorrhage', 'Injection site swelling', 'Pain in extremity', 'Peripheral swelling']",UNK,PFIZER\BIONTECH, 923399,ID,36.0,M,Vertigo,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,PVT,,,,,,['Vertigo'],1,PFIZER\BIONTECH,IM 923400,AZ,56.0,F,"Covid 19 test: Nasal Swab Result: Positive; Covid 19 test: Nasal Swab Result: Positive; Severe joint swelling oral viral sores left lung fluid exhaustion; Severe joint swelling oral viral sores left lung fluid exhaustion; Severe joint swelling oral viral sores left lung fluid exhaustion; This is a spontaneous report from a contactable Other HCP (patient). A 56-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 24Dec2020 12:00 at a single dose for COVID-19 immunization at the hospital. Medical history included juvenile idiopathic arthritis (JRA). The patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications included imipramine, nebivolol hydrochloride (BYSTOLIC), and topiramate (TOPAMAX). The patient received other vaccine within 4 weeks prior to the COVID vaccine which is J&J cv trial. The patient experienced severe joint swelling, oral viral sores, and left lung fluid exhaustion on 25Dec2020 06:00; it was reported that no treatment was given for these. The patient tested for COVID-19 post vaccination. The COVID-19 test post vaccination was a Nasal Swab (Abbott Binax) on 27Dec2020. The COVID-19 test result was positive. Outcome of the events severe joint swelling, oral viral sores, and left lung fluid exhaustion was recovering; for the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (COVID-19 test positive) with BNT162b2 can not be fully excluded. Based on the close temporal relationship, the association between the event left lung fluid exhaustion with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,PVT,; BYSTOLIC; TOPAMAX,,Medical History/Concurrent Conditions: Juvenile rheumatoid arthritis,,,"['Inappropriate schedule of product administration', 'Joint swelling', 'Oral viral infection', 'Pulmonary oedema', 'SARS-CoV-2 test positive', 'Stomatitis']",1,PFIZER\BIONTECH,OT 923401,IL,49.0,F,I had a high fever 102.2. I had nausea and diarrhea.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,WRK,"Levothyroxine, Vitamin B supplement, Dhea Supplements, Fluoxetine",I was diagnostic with COVID-19; up till 29 days before.,None,,Metronidazole and Flua,"['Diarrhoea', 'Nausea', 'Pyrexia']",1,MODERNA,IM 923402,CA,39.0,F,"blood pressure went up to 150/101; feeling like fainting; feeling really tired; Weakness; irregular heart beat; sob; feeling like flushing in the body; chills; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on the left arm on 30Dec2020 07:15 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, depression, cardiac murmur and pvc. The patient hadno known drug allergies and had not tested for COVID-19 prior and after vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID), ergocalciferol (VITAMIN D), tocopherol (VITAMIN E) and sertraline hydrochloride (ZOLOFT). The patient experienced weakness, irregular heart beat, feeling like fainting, sob, blood pressure went up to 150/101, feeling like flushing in the body, chills, feeling really tired, all on 30Dec2020 07:15. The patient received treatment. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event ""blood pressure went up to 150/101"" with BNT162b2 can not fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,SYNTHROID; VITAMIN D; VITAMIN E; ZOLOFT,,Medical History/Concurrent Conditions: Depression; Heart murmur; Hypothyroidism; Premature ventricular contractions,,,"['Asthenia', 'Blood pressure increased', 'Chills', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Flushing', 'Heart rate irregular']",1,PFIZER\BIONTECH,OT 923403,GA,,F,"Got the first Pfizer COVID Vaccine and today I tested positive for COVID; Got the first Pfizer COVID Vaccine and today I tested positive for COVID; Congestion; Sore throat; This is a spontaneous report from a contactable consumer reporting for herself. A 26-years-old female patient received bnt162b2 (BNT162B2; Lot # EL0140) vaccine , via an unspecified route of administration on an unknown date in Dec2020 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient stated she got the first Pfizer Covid vaccine and on an unknown date in Dec2020 she tested positive for Covid 19, she also experienced nasal congestion and sore throat. The outcome of the events is unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Nasal congestion', 'Oropharyngeal pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 923404,OK,56.0,M,"Mild pain at the injection site the next day; Mild headache within 1-2 hours of injection; Mild headache within 1-2 hours of injection; This is a spontaneous report received from a contactable physician (who is also the patient). A 56-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH 9899), via an unspecified route of administration in left arm on 18Dec2020 13:15 at single dose for COVID-19 immunization. Medical history included history of headaches and dyslipidemia. The patient has no known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced mild headache within 1-2 hours of injection on 18Dec2020 and mild pain at the injection site the next day on 19Dec2020. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Dec2020 (reported as ""resolved within 24-48 hours""). The reporter assessed the report as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,WRK,,,Medical History/Concurrent Conditions: Dyslipidemia; Headache,,,"['Disease recurrence', 'Headache', 'Vaccination site pain']",1,PFIZER\BIONTECH, 923405,AK,63.0,F,SORE ON RIGHT ARM,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,UNK,,,,,,['Injection site pain'],1,PFIZER\BIONTECH,IM 923406,GA,50.0,F,"anaphylaxis; throat swelling; This is a spontaneous report from a contactable physician. A 50-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension, lipids (as reported) and asthma. The patient was known allergies: codeine, iodine, shellfish, latex, and cefatrizine propyleneglycolate (CEFTIN). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in hospital. The patient experienced anaphylaxis and throat swelling on 22Dec2020 with outcome of recovered in Dec2020. The events were reported as non-serious. The events resulted in Emergency room/department or urgent care. Treatment of epinephrine, steroids, antihistamines, observation was received for the events. Information on lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis and throat swelling cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,,,PVT,,,Medical History/Concurrent Conditions: Asthma; COVID-19; Hypertension; Latex allergy; Lipids abnormal; Shellfish allergy,,,"['Anaphylactic reaction', 'Pharyngeal swelling']",UNK,PFIZER\BIONTECH, 923408,CO,51.0,M,patient described left arm pain that radiates up his arm and into his neck and that he couldn't continue to work the rest of the day on 1/6/21. recommended that he use ibuprofen for muscle pain and to contact his provider if symptoms increase,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,unknown,None,unknown,,unknown,"['Impaired work ability', 'Limb discomfort', 'Neck pain', 'Pain']",1,MODERNA,IM 923409,NY,,M,"the patient experienced tinnitus; This is a spontaneous report from a contactable pharmacist. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Dec2020 at single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient experienced tinnitus (tinnitus) on Dec2020 after receiving the vaccine. The patient went to see his doctor, but no cause for the tinnitus was identified. No treatment for the tinnitus was administered. Outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/01/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Tinnitus'],UNK,PFIZER\BIONTECH, 923410,MA,52.0,F,"Headache; Sore arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142) via an unspecified route of administration on 30Dec2020 10:00 at single dose for covid-19 immunisation. Medical history included hypertension, high cholesterol and asthma. Concomitant medication included cetirizine hydrochloride (ZYRTEC), hctz (HCTZ), metoprolol succinate (TOPROL XL), omeprazole (OMEPRAZOLE) and pravastatin (PRAVASTATIN). The patient previously took diphenhydramine (BENADRYL) and experienced drug allergy. The patient experienced headache and sore arm on 30Dec2020 13:00. Outcome of events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,ZYRTEC [CETIRIZINE HYDROCHLORIDE]; HCTZ; TOPROL XL; ;,,Medical History/Concurrent Conditions: Asthma; High cholesterol; Hypertension,,,"['Headache', 'Pain in extremity']",1,PFIZER\BIONTECH, 923411,WA,23.0,F,"Received the vaccine around 9:15 pm PST. Arrived home and went to sleep. Around 11:15 PM PST, was awoken with extreme chest pains, nausea, and headache. Attempted to get up to get to the bathroom, and was unable to make it there prior to fainintng. Was able to come to cognitively but was unable to move or get up. Had an overwhelming feeling of extreme muscle weakness. Was getting muscles spasms in the legs and extreme fatigue. Husband was able to get her up and dressed and took her to ER for a full work up. Was there from 12-3am PST.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,Unknown,None known of.,unknown.,,Unknown,"['Asthenia', 'Chest pain', 'Electrocardiogram', 'Fatigue', 'Headache', 'Laboratory test', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Muscle spasms', 'Muscular weakness', 'Nausea', 'Syncope']",1,MODERNA,IM 923412,CO,25.0,F,"she got tunnel vision; almost passed out; Blood pressure dropped to 70/50; heart rate went up to 140; whole body got cold and tingly; whole body got cold and tingly; This is a spontaneous report from a contactable pharmacist (patient) reported for herself. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer Biotech; lot number: EL0142) via an unspecified route of administration at left arm on 30Dec2020 at 12:45 PM at a single dose (dose number: 1) for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Medical history included premature ventricular contractions (PVCs). No known allergies (no allergies to medications, food, or other products). The patient was not pregnant. No other vaccine in four weeks and no other medications in two weeks. The patient experienced adverse events included blood pressure dropped to 70/50, heart rate went up to 140, whole body got cold and tingly and she got tunnel vision and almost passed out. The events all started on 30Dec2020 at 12:45 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the close temporal relationship, the association between the event tunnel vision with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,,,Medical History/Concurrent Conditions: Premature ventricular contractions,,,"['Altered state of consciousness', 'Blood pressure decreased', 'Feeling cold', 'Heart rate increased', 'Paraesthesia', 'Tunnel vision']",1,PFIZER\BIONTECH, 923413,NH,49.0,M,"The body aches started in his shoulder and now are all over his neck, back and whole body aches; The body aches started in his shoulder and now are all over his neck, back and whole body aches/ feeling like he has 1,000 pounds on his back; The body aches started in his shoulder and now are all over his neck, back and whole body aches; Body aches/The body aches started in his shoulder and now are all over his neck, back and whole body aches; Headache; Chills; Feel like crap; Low grade temperature; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old male patient received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL0142) intramuscularly at right shoulder approximately at 17:30 on 29Dec2020 for Covid-19 immunization. The patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity (a little over weight but he is fit). The patient had COVID in the end of Apr2020. The patient had no family medical history and had no prior vaccinations within four weeks. The patient had no concomitant medication. The second day of the vaccination, the patient called to report body aches, headache, chills, low grade temperature. As he reported, he just woke up and was walking around feeling like he had 1000 pounds on his back and felt like crap. The body aches started in his shoulder and currently all over his neck, back and whole body aches. Chills started last night (vaccination night). He was just trying to get to sleep and had to put an extra sweatshirt on last night. He did not check his temperature until he got up and it was 99.2 degrees Fahrenheit. He was not able to provide a start date for the temperature. ""Body aches, headache between, chills between, low grade temperature (unspecified start date), feels like crap"" were considered developing between 24:00-01:00. He stated that they were all medically significant and he needs a day to recover hopefully. He just felt like he was hit by a truck. The patient had not visited physician or went to ER yet. The outcome of low grade temperature was unknown, chills was resolving and all other events did not resolve at the time of reporting.; Sender's Comments: There is a reasonable possibility that the events vaccination site pain, headache, chills, and pyrexia were related to BNT162b2 based on known drug safety profile. The association between the other reported events with BNT162b2 can not be completely excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/01/2020,,PVT,,,Medical History/Concurrent Conditions: Allergic reaction; Chromosomal anomalies; COVID-19; Diabetes; Endocrine disorder; Immune imbalance; Obesity; Respiratory disorder,,,"['Chills', 'Discomfort', 'Headache', 'Injection site pain', 'Malaise', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,OT 923414,GA,66.0,F,"severe chills, dry stinging mouth, headache, dehydration, dry heaves,nausea, for approximately 6 hrs. The symptoms resolved then she experienced Headache, fatigue body aches until 01/06/2021 @0600.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"Fosamax, Saxenda, MVI",none,none,,none,"['Chills', 'Dehydration', 'Dry mouth', 'Fatigue', 'Headache', 'Nausea', 'Oral pain', 'Pain', 'Retching']",2,PFIZER\BIONTECH,IM 923415,NY,,F,"A nurse got Bell's Palsy after the vaccine; heart attack; This is a spontaneous report from a contactable consumer. A female patient (nurse) of an unspecified age received single dose of BNT162B2 (batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. The consumer asked if Pfizer have more information if so then what's the ingredients. States that ""injury lawyers know how many deaths because of the vaccine. Bell's palsy, a nurse got Bell Palsy after the vaccine, she is all distorted, and 30 days later, that's the 2nd one to have a heart attack."" The outcome of the events was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Facial paralysis', 'Myocardial infarction']",UNK,PFIZER\BIONTECH, 923416,NY,,F,"2nd one to have a heart attack; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 via an unspecified route of administration on an unspecified date at a single dose as Covid vaccine. Medical history and concomitant medications were not reported. After stating Pfizer has submitted a request for Emergency Use Authorization for potential COVID-19 vaccine and it was now in the FDA's hands, the reporter inquired if Pfizer had more information if so then what's the ingredients. It was then reported that the patient's the 2nd one to have a heart attack on an unspecified date. The outcome of the event was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: The association between the event heart attack with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Myocardial infarction'],UNK,PFIZER\BIONTECH, 923417,IL,40.0,F,"On 12/28/2020 around 9 PM she started feeling fatigued. Also noticed L arm tenderness at this time. This has continued since this time.. She knew it has been sore, hurting and swollen. Yesterday 1/5/2021, she had her daughter look at site and take pictures, she was able to see redness and she could feel heat radiating from this. She went to urgent care.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PUB,Wellbutrine 50 mg 1 po qd HCTZ 25 mg 1 po qd Synthroid 125 mcg 1 po qd Clonopine (prn but has not taken in a long time) 0.5 mg 1 po prn,None that she is aware of.,HTN Hypothyroidism anxiety depression,,NKA,"['Fatigue', 'Injection site erythema', 'Injection site warmth', 'Pain in extremity', 'Peripheral swelling', 'Tenderness']",1,MODERNA,IM 923418,NJ,63.0,F,"right mouth drop; right face numbness from eyebrow to below chin with right mouth drop; pins and needles feeling at injection site; then ears itching; This is a spontaneous report from a contactable nurse, the patient. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EK9231), via an unspecified route of administration, on 30Dec2020 at 03:45 AM (at the age of 63-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a workplace clinic and anatomically located on the right arm. Medical history included: History of Guillain Barre in 1970's with Swine Flu Vaccine. Concomitant medications included: clonidine (MANUFACTURER UNKNOWN), hydralazine ((MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took unspecified medications (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced sensitivity to some medications, and unknown if ongoing. On 31Dec2020 04:15 PM, the patient reported ""Within 30 minutes of vaccine, I had pins & needle feeling at injection site. Then ears itching followed by right face numbness from eyebrow to below chin with right mouth drop."" The patient did not receive any treatment for the events. The clinical outcome of the events pins & needle feeling at injection site, ears itching followed by right face numbness from eyebrow to below chin with right mouth drop, was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the temporal association.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,; ; SPIROLACTONE;,,,,,"['Ear pruritus', 'Facial paralysis', 'Hypoaesthesia', 'Injection site reaction', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 923419,CO,37.0,F,"Bell's Palsy; This is a spontaneous report from a contactable physician. A 37-year-old female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration on 29Dec2020 17:50 (5:50 pm) at a single dose as Covid vaccine. Medical history included hypertension and depression. Concomitant medications included venlafaxine hydrochloride (EFFEXOR); olmesartan medoxomil (BENICAR); and unspecified medications for depression and blood pressure medication (hypertension). It was reported that the reporter's nurse got her vaccine last night, about 6'o clock at night, and woke up with Bell's Palsy on Dec2020. She woke up in midnight to go to the bathroom and when she looked in the mirror, she noticed that there was discrepancy. The physician examined her this morning, so it was in several hours getting the vaccine that she noticed it. She got the vaccination last night at 5:50 pm. When she went to bed it wasn't a problem. She woke up at midnight and noticed it. The patient was started on Medrol dose pack but she hasn't taken it yet because she's at work so she would start it today (unknown if the treatment was already received); it's steroid, Methylprednisolone, at 24 mg on day one and then decreases 4 mg a day over the next five days until it's done. The doctor inquired what should the patient do about her second dose and also asked if she should not get her second dose. The outcome of the event was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/01/2020,,UNK,EFFEXOR; BENICAR,,Medical History/Concurrent Conditions: Depression; Hypertension,,,['Facial paralysis'],1,PFIZER\BIONTECH, 923421,MO,,F,"edema started in her feet and ankles and then moved 3 quarter way to her shin; 4+ pitting edema; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported she received the Covid vaccine on 17Dec2020 and on 25Dec2020 she noticed her shoes were snug and on 26Dec2020 she noticed 4+ pitting edema lasting 3 days. She went and brought some compression stockings and this has helped the edema improve but was still mild. The edema started in her feet and ankles and then moved 3 quarter way to her shin. She would like to know if she should receive second dose of Pfizer vaccine. Outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/25/2020,8.0,UNK,,,,,,['Oedema peripheral'],1,PFIZER\BIONTECH, 923422,UT,38.0,F,"Having trouble clearing my throat, felt like it was closing up; Having trouble clearing my throat, felt like it was closing up; Uncontrollable rigors; High heart rate; Numb lips and hands; Numb lips and hands; Nausea; Shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A 38-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685, expiry date 30Dec2020) intramuscular (Arm Left), on 30Dec2020 09:15, single dose, for COVID-19 immunization. Relevant medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had gall bladder removed, and had tonsils removed. It was reported that the patient cannot take NSAIDS, patient was not allergic to them. No allergies to food or other products. Concomitant medications included rizatriptan and paracetamol (TYLENOL). On 30Dec2020, within about 10 minutes of the injection of the vaccine, the patient had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea. The patient was discharged from the ED, went home and took a nap. Later that evening, the patient began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath, and was admitted to the ED again and given more IV medications. Therapeutic measures given in response to the event included administration of IV medications, epinephrine injection and breathing treatment. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks, was not tested or diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events oropharyngeal discomfort, throat tightness, chills, heart rate increased, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,; TYLENOL,,"Medical History/Concurrent Conditions: Anterior vaginal wall repair; Bariatric surgery; Bladder sling procedure; Drug intolerance (cannot take NSAIDS, patient was not allergic to them. No allergies to food or other products.); Gallbladder removal; Tonsillectomy",,,"['Chills', 'Dyspnoea', 'Heart rate increased', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Nausea', 'Throat clearing', 'Throat tightness']",1,PFIZER\BIONTECH,OT 923423,ME,30.0,F,"The day after dose #1 of Moderna the left deltoid was red, hard, and raised approximately 2 - 2 1/2 inches in diameter. Reported 7 days after vaccination and still erythematous. Advised Ibuprofen and cold packs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,None,None,None,,None,"['Injection site erythema', 'Injection site induration', 'Injection site swelling']",1,MODERNA,IM 923425,WI,62.0,F,"1/2 - 1/4 developed chills, nausea which is par for the course 1/5 continued with same symptoms and then developed hives, back, arms, legs, ankles and feet 1/5 directed to: given prednisone 50mg, bendryl 50mg and zyrtec 10 mg in ED and then given script for Prednisone 50mg 1 tablet daily for 5 days, zrytec 10 mg, 1 tablet daily and benadryl 50 mg every 6 hours as needed",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/05/2021,6.0,PVT,none,no,none,,non known,"['Chills', 'Nausea', 'Urticaria']",1,MODERNA,IM 923426,MT,33.0,F,"Chest Tightness, Flushing, Difficulty breathing",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Chest discomfort', 'Dyspnoea', 'Flushing']",1,PFIZER\BIONTECH,IM 923427,OH,36.0,F,"Temperature 102.3, shaking, body aches, headache, weakness, fatigue. Rash and bruise at insertion site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Multivitamin,Covid 12/22/2020,None,,None,"['Asthenia', 'Body temperature increased', 'Fatigue', 'Headache', 'Injection site bruising', 'Injection site rash', 'Pain', 'Tremor']",1,MODERNA,IM 923428,WA,38.0,F,"On the date of the vaccine was given patient reports symptoms that included nausea, fatigue, joint pain, a numbing sensation of the throat and tongue, the feeling of palpations, and hives around bra line. The symptoms improved with Benadryl and within 24 hrs. On 1/5/2021 Patient was seen for a local skin reaction at the injection site. Reports pain on the right upper arms and warm to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Celexa, Ambien, Spirolactone, tylenol, birth control mono-linyah",none,"Seasonal Allergies, Acne, sensitivity to chemical and materials",,"Nsaids, Sulfa, Doxycline, Trazadone. Nickle, Limonene, Apples, Latex, skin close adhesive","['Arthralgia', 'Fatigue', 'Hypoaesthesia oral', 'Injection site pain', 'Injection site reaction', 'Injection site warmth', 'Nausea', 'Palpitations', 'Pharyngeal hypoaesthesia', 'Skin reaction', 'Urticaria']",1,MODERNA,IM 923429,TX,67.0,F,"MODERNA COVID 19 VACCINE EUA. Warm, red circular area approx 2.5 inches diameter around center of vaccination needle entry, was itching approx 2 days and now just warm and firm to touch, still some redness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 923430,AK,82.0,F,SORE LEFT ARM,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH,IM 923431,,50.0,M,Neck and Face flushing. Tachycardia with rate of 120 for 1.5 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/16/2020,12/16/2020,0.0,PVT,,,,,,"['Flushing', 'Tachycardia']",1,PFIZER\BIONTECH,IM 923432,IN,62.0,M,"Chills, followed by shaking chills, myalgias, vomiting (x1), headache, lethargy. Chills, myalgias, headache and lethargy lasted all night then took Naproxen in the AM and was able to go to work. Stayed on Naproxen all day and all the next night with no additional symptoms (other than extreme tiredness) throughout the day until night two had drenching night sweats throughout the entire night (changed drenched t-shirt 5 times, soaked sheets and pillow case, until up to go to work at 6:00 AM. Since morning no additional symptoms including no tiredness/lethargy. I currently feel completely normal. Last dose of naproxen was at 6:00 AM and no symptoms since. Currently 1:45 PM.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,none,none,none,,none,"['Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Lethargy', 'Myalgia', 'Night sweats', 'Tremor']",2,PFIZER\BIONTECH,IM 923433,MA,31.0,F,"Approx 25 minutes after vaccination developed tingling/burning sensation lips, tongue and hard palate",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,Prenatal Vitamins,none,none,Local redness/swelling after Tdap approx 2017 age 28 -- did not seek medical care,Sulfa Antibiotic,"['Burning sensation', 'Paraesthesia', 'Paraesthesia oral', 'Pharyngeal paraesthesia']",1,MODERNA,IM 923434,UT,47.0,F,"onset of itching, redness, swelling, pain, hot at injection site at day 7 after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/31/2020,7.0,PUB,"Zolpidem, famotidine",NONE,NONE,,NONE,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 923435,MA,49.0,F,"Approximately 10-15 minutes post vaccination patient developed ""flushing"" sensation and felt as though heart was racing. Pulse was noted regular and even. Started feeling anxious. Patient was brought to treatment room. Vital signs stable. Stated began to ""see stars"" in corner of eyes. Nystagmus noted in right eye upon neuro exam. EKG obtained and patient noted with PVCs. Patient also noted with redness surrounding both eyes which continued to progress and did not dissipate over time. Patient stated significant allergy history and was carrying 2 epipens to vaccination. Patient was transported via EMS to local ER for monitoring and discharged home after 2-3 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,MIL,unknown,unknown,"sinusitis, mammalian meat allergy, mitral valve regurgitation, anxiety, MOHS for basal cell carcinoma",,history of mammalian meat allergy requiring epi-pen,"['Anxiety', 'Electrocardiogram abnormal', 'Flushing', 'Neurological examination', 'Nystagmus', 'Ocular hyperaemia', 'Palpitations', 'Ventricular extrasystoles', 'Visual impairment']",1,MODERNA,IM 923436,CO,63.0,F,Pt has a mild rash that covers the injection site and large parts of the chest. Pt advised to take allergy medications,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PHM,,,,,,"['Injection site rash', 'Rash']",1,PFIZER\BIONTECH,IM 923437,ID,46.0,F,"Headache, Nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/02/2021,5.0,PVT,,,,,,"['Headache', 'Nausea']",1,MODERNA,IM 923439,AK,82.0,F,SORE LEFT ARM,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,OTH,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH,IM 923441,,38.0,F,"Woke up with sore left arm and some redness and swelling at injection site on 1.5.21. Chills and generalized body aches began about 1230, temperature taken at that time was 99.0. Continued with work and by 1530 began to have increased myalgias and pain in knees, took temperature 100.0 and took 400mg Ibuprofen. Fever broke, began to have diaphoresis and felt body aches were gone with exception to left arm. Woke up 1.6.21 and with pain in left axilla and noted to have tender and swollen lymphnodes. Took another 400mg Ibuprofen about 0830. Muscle pains remain to arm, axilla and neck.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PVT,,,,,,"['Arthralgia', 'Axillary pain', 'Chills', 'Hyperhidrosis', 'Injection site erythema', 'Injection site swelling', 'Lymphadenopathy', 'Myalgia', 'Pain', 'Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH, 923442,CO,37.0,F,"1/4/21 (one week after vaccination) redness, itching, swelling, painful, hot to touch, increasing in size",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,WRK,"prenatal vitamin, vitamin d, b complex, omega 3, magnesium, l-theanine, herbal tincture",sinus headache one week before vaccination,no,,no,"['Erythema', 'Pain', 'Pruritus', 'Skin warm', 'Swelling']",UNK,MODERNA,IM 923443,MN,34.0,F,"chills, weakness, muscle aches, rapid heart rate, elevated blood pressure, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,,Diagnosed with Covid-19 10/6/2020,,,NKA,"['Asthenia', 'Blood pressure increased', 'Chills', 'Headache', 'Heart rate increased', 'Myalgia']",1,MODERNA,IM 923444,KS,38.0,F,loss of taste started around 10am 1-5-2021 and has continued. major headache aprox 2 hours after injection received on 1-4-2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,"lisdexamfetamine 60mg, bupropion 300mg, breo ellipta 100-25 mcg/inh inhaler, metoprolol succinate 50mg, desvenlafaxine 100mg",none,"add, depression, high bp, asthma",,penicillin,"['Ageusia', 'Headache']",1,MODERNA,IM 923445,AZ,36.0,F,Left arm injection site. There was redness and warmth followed by large circular area that persisted approximately 5-7 days. Incident occurred 7 days after injection. Itching for 1-2 days that was not distracting. No further care needed and therefore I only noted timeframe.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,PHM,"Levothyroxine, Spirinolactone",none,"hypothyroidism, rosacia",,Penicillin,"['Erythema', 'Pruritus', 'Skin warm', 'Urticaria']",1,MODERNA,IM 923446,MT,38.0,F,"Itching in throat, Burning in chest",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Chest pain', 'Throat irritation']",1,PFIZER\BIONTECH,IM 923447,MI,39.0,F,"Associate began to c/o hand numbness to left arm with fingers tingling. 1135: 183/98 BP, HR 68, Oxygen 100% on room air. 1140: BP 179/111, HR 79, oxygen 100% 1145: BP 160/104. HR 72. Oxygen 100. Associate states numbness has resolved and to followup with her PCP about elevated BP and numbness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Blood pressure increased', 'Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 923448,ID,46.0,F,Headache and Nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/02/2021,5.0,PVT,,,,,,"['Headache', 'Nausea']",1,MODERNA,IM 923449,WV,39.0,F,Development of right arm itching and redness at injection site approximately 8 days s/p immunization. Treatment with Benadryl 50mg PO x 1 on day 2 of reaction and Augmentin 875mg PO bid x 10 days (started on day 2 of reaction; currently on day 6 of Augmentin Tx). Slow central clearing started within the area of skin redness within 24-48 hrs s/p initiation of oral medications with almost complete resolution of redness within about 96 hours of Tx. Residual itching remained for approximately 5 days even after reduction of skin redness. Only a very minimal amount of muscle soreness developed on day two of the skin eruption and subsided within about 24-36 hours. Sx isolated only at the injection site. No systemic Sx.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PVT,None,None,None,Minimal amount of red-streaking at injection site in opposite arm (left arm) after 2020 Influenza Flulaval injection in Septembe,None,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 923450,,32.0,F,"Itching/rash, no medications given, patient went home on her own.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,cephalosporin's,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 923451,MA,42.0,F,blurry vision,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,PVT,,,,,,['Vision blurred'],1,MODERNA,IM 923452,RI,23.0,F,"Developed chest tightness, sore throat, Wheezing and flushed face",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,"ERITHROMYCIN, ALLEGRA, SUDAFED","['Chest discomfort', 'Flushing', 'Oropharyngeal pain', 'Wheezing']",2,PFIZER\BIONTECH,IM 923453,AK,83.0,F,LITTLE SORENESS ON VACCINE SITE,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,OTH,,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH,IM 923454,CA,53.0,F,"I started having nausea, headache and nasal congestion at 2:54 pm on 12/19/2020. This lasted until 12/21/2020 at 9:23 pm. I had tried Sprix, Zomig 5mg and Promethazine 12.5mg. The nausea went away, but the headache persisted. I had originally thought it was a migraine and treated it as such, but my rescue medications did not work, so I thought it could be a side effect of the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,WRK,"Multivitamin, Calcium with Vitamin D, Vitamin E, Biotin, Melatonin, Culturelle, Excedrin Migraine, Tylenol, Furosemide, Omeprazole, Xyzal, Flonase, Vitamin B-12, Lamictal, Emgality, Zicam",Migraine headaches,"Migraine headaches, bipolar disorder, PTSD, GERD",,"Imitrex, Morphine, Demerol, Honeydew Melon, Walnut trees","['Headache', 'Nasal congestion', 'Nausea']",1,PFIZER\BIONTECH,IM 923455,CO,63.0,F,Rash to the site on injection and large parts of the chest,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Injection site rash', 'Rash']",1,PFIZER\BIONTECH,IM 923456,IA,59.0,F,"Right hand/forearm swelling, edema",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PUB,"Flonase, Levothyroxine, Azulfidine, Methylphanidate, Estradol patches, Vitamin D3, Fiber supplement, women's multivitamin",,10 years ago immunotherapy for allergies,,,"['Oedema', 'Peripheral swelling']",1,MODERNA,IM 923457,CA,25.0,F,Ringing in ears Sore lymph nodes Main soreness on left leg and hand on left side (only one sided pain)? Neck pain and chest soreness Fatigue/tiredness,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,Junel/fe 120,No,No,,Vancomycin,"['Chest pain', 'Fatigue', 'Lymph node pain', 'Neck pain', 'Pain in extremity', 'Tinnitus']",1,PFIZER\BIONTECH,SYR 923458,OH,31.0,M,"After 9min of getting vaccine I experienced heavy breathing and dizziness which lasted for a minute and got normal. Again after 18minutes of getting the vaccine, same thing happened. I was in a sitting position for 20min. After 22min i felt itching on my left foot finger and neck for few minutes. I feel these are side effects of vaccine as i never had such feeling before for any medication.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Multi vitamins,,"Irritable bowel syndrome, migraine headaches",,Shell fish,"['Dizziness', 'Dyspnoea', 'Pruritus']",1,MODERNA,SYR 923459,OK,49.0,M,"patient was noted to be flushed by residential home staff on 12/30/2020, approximately 2.5hrs after vaccination, fever present at that time. Prior to COVID19 vaccine administration, this patient did have exposure and was close contact with a known case of COVID19 in a residential care employee. Patient was taken to hospital for evaluation of febrile status, had positive COVID19 test at that time, and reported hypotension per residential care staff.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,"allopurinol 100mg QD, Dilantin 30mg 2 cap QD, escitalopram 10mg QD, Zetia 10mg QD, loratadine 10mg QD, meloxicam 7.5mg QD, omeprazole 20mg QD, phenytoin EX 100mg 3 tabs QHS, phenytoin EX 100mg 2 tabs QAM, polymyxin b/trimethoprim solution 1",None,"gout, optic nerve problem, dry eye syndrome, seizure disorder, depression, blepharitis, intellectual disability, Down syndrome, gingivitis, psychosis, myopia, seborrheic dermatitis, GERD, hypokalemia",,No known allergies,"['Flushing', 'Hypotension', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 923460,CO,29.0,F,I received the first dose and one week later I formed a rash on my lower legs and a fever. The doctors suspect Erythema nodosum but the tests are still pending.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/25/2020,6.0,WRK,None,None,"Asthma, Allergies",,None,"['Biopsy', 'C-reactive protein', 'Erythema nodosum', 'Pyrexia', 'Rash']",UNK,PFIZER\BIONTECH,IM 923461,MN,34.0,F,"Patient developed prickly tongue and itchy throat two hours after vaccination. Patient developed an upper body rash on core, arms and face 7-8 hours after vaccination. Patient took Benadryl and prickly tongue and itchy throat went away but still has upper body rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PUB,"Started taking Pepcid two weeks ago, tylenol and ibuprofen as needed.",No illness,Acid Reflux,,"Penacillin, amoxacillin, sulfa drugs, codeine, depakote, imodium, toradol, bananas , latex, cats, ciprofloxine, lamictal","['Paraesthesia oral', 'Rash', 'Throat irritation']",1,MODERNA,IM 923462,AK,89.0,F,LITTLE SORENESS ON VACCINE SITE,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,OTH,,,,,,['Vaccination site pain'],UNK,PFIZER\BIONTECH,IM 923463,NV,35.0,F,"Had a rash right after vaccine arm and cheeks rosy and rash primarily on arms and chest. Lasted about 15-20 minutes and left vaccination area. Later that evening fatigue, chills, temp and body aches were extreme. dizzy and nausea with standing. unable to work and could only hold down minimal fluid or food. Next day same with night sweats and now has a cough and sore throat. Body aches have decreased. Patient reports having COVID 45 days ago but was nothing like these symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PUB,probiotics,denies,chronic depression and add,,"50 mg Prestiq, 10 mg extended release Adderall, Zyrtec, flonase","['Body temperature abnormal', 'Chills', 'Cough', 'Dizziness postural', 'Erythema', 'Fatigue', 'Hypophagia', 'Impaired work ability', 'Nausea', 'Night sweats', 'Oropharyngeal pain', 'Pain', 'Rash']",1,MODERNA,IM 923464,VA,47.0,F,"Began with symptoms for shingles 72 hrs post vaccine, severe outbreak that still not has resolved and currently on second round of anti-virals; delaying second vaccine until shingles resolve",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/20/2020,3.0,PVT,"HCTZ, Prevastatin, ASA, Atenalol",None,High BP and cholesterol,,NKA,['Herpes zoster'],1,PFIZER\BIONTECH,IM 923465,WV,46.0,F,"pain, redness, swelling at injection site 1 week post vaccine with left axillary adenopathy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,PVT,"zyrtec, melatonin, flonase",none,"allergies, mild intermittent asthma, migraines",,shellfish,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy']",1,MODERNA,IM 923466,MN,34.0,F,"chills, muscle aches, weakness, SOB, rapid heart rate (134) elevated blood pressure (162/120),",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,,Diagnosed with Covid-19 10/6/20,,,NKA,"['Asthenia', 'Blood pressure increased', 'Chills', 'Dyspnoea', 'Heart rate increased', 'Myalgia']",1,MODERNA,IM 923467,MS,47.0,F,Moderna COVID-19 Vaccine EUA Face swelling fever 100.3-102.5 headache body aches joint pain,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,,,PVT,multiple vaccine vitamin D3 probiotic,"COVID Dec 3-13, 2020",migraine headaches,,pcn = rash,"['Arthralgia', 'Pain', 'Pyrexia', 'Swelling face']",UNK,MODERNA,IM 923468,CA,53.0,M,"Extreme Arm Soreness Painful axillary lymphadenopathy on side of injection Flu like symptoms (Fever, HA, Muscle aches, malaise, chills) Abdominal cramping",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,None,None,None,,None,"['Abdominal pain', 'Chills', 'Headache', 'Influenza like illness', 'Lymphadenopathy', 'Malaise', 'Myalgia', 'Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 923470,FL,52.0,M,"Long bone aching pain, involving bilateral humeral bones and left femur. Pain began on day two and resolved on day five. I required two doses of ibuprofen to sleep on days three and four.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,"Citalopram, fexofenadine",None,Asthma,,NKA,['Pain in extremity'],1,PFIZER\BIONTECH,IM 923471,MO,19.0,F,"Injection at 0800 at 1800 day of injection started feeling flushing, head pressure, and nausea. Day after immunization 1/5/2021 fever of 102.3 all day. Was able to be brought down using acetaminophen. She had what she described as severe hot and cold chills throughout the day. As of the time she reported to me 1/6/2021 @ approximately 1225 her fever had resolved. She still had slight lingering nausea and headache, but felt much better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,PVT,,,,,,"['Chills', 'Feeling of body temperature change', 'Flushing', 'Head discomfort', 'Nausea']",1,MODERNA,IM 923472,GA,40.0,F,"Received vaccine in left arm the morning of 12/23/2020. Developed itchy palms and rash on torso the evening on 12/25/2020. Took Benadryl at onset. Did not seek medical attention. Reported incident on 01/06/2021. Rash almost gone, remaining only on left hand and very faded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/25/2020,2.0,PVT,"Astelin, Flonase, Singulair, Albuterol, Xolair, Zetia, Simvastatin, Breo, Lunesta, Zoloft, Allegra, Allergy Immunotherapy",URI 3 weeks prior to vaccine,"Asthma, Allergies, Hyperlipidemia",,"Levaquin (rash and skin sensitivity), Augmentin (rash), Triamcinolone cream (rash)","['Pruritus', 'Rash']",UNK,PFIZER\BIONTECH,IM 923473,KY,42.0,F,"Extreme sore arm, body aches, chills, nausea, loss of appetite, diarrhea, slight headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Beyaz,None,None,,NKDA,"['Chills', 'Decreased appetite', 'Diarrhoea', 'Headache', 'Nausea', 'Pain', 'Pain in extremity']",2,MODERNA,IM 923474,NC,59.0,F,"I received my vaccine on 12/29/2020. I work on contract for hospice. I had no issues the day of the vaccine. For the next 6 days I had no issues, problems, complaints, etc. On 1/5, I noticed a raised, red warm rash that is 6 cm in diameter over the injection site. It is non-tender. No streaking or drainage. I feel fine. No fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,Premarin Elavil Clonazepam,None,None,,None,"['Injection site erythema', 'Injection site rash', 'Injection site warmth', 'Rash papular']",UNK,MODERNA,IM 923475,NY,67.0,F,"severe headache, fever, nausea, frequent bowels, injection site pain, chills, joint pain - it felt like 36 hours of bad flu",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"lots of Vitamins & some herbs, including Vit C, D2, K2, Calcium, Magnesium, Krill Oil, Curcumin, Lutein, etc",none,none,shingles,none aware of,"['Arthralgia', 'Chills', 'Feeling abnormal', 'Frequent bowel movements', 'Headache', 'Injection site pain', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 923476,AK,91.0,F,LITTLE SORENESS ON VACCINE SITE,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,OTH,,,,,,['Injection site pain'],1,PFIZER\BIONTECH,IM 923477,IL,49.0,F,I had a fever with a temperature of 102.2. Also I felt nausea and had diarrhea.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,WRK,I take vitamin B and Synthroid,I was positive for COVID-19 up till 29 days before.,None,,Metromidze,"['Diarrhoea', 'Nausea', 'Pyrexia']",1,MODERNA,IM 923478,CO,36.0,F,"About 5-6 days after getting the vaccine, developed knot under the skin at the site of the vaccine, then developed redness and itching with slightly increased swelling. Seems to be slightly improving (9 days after vaccine and about 3 days after reaction started).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,PVT,"Zoloft, prenatal vitamin, colace",none,depression,,none,"['Injection site erythema', 'Injection site pruritus', 'Vaccination site nodule', 'Vaccination site swelling']",1,MODERNA,IM 923479,CA,36.0,F,"redness, inflammation (muscle and skin), warmth, soreness at injection site >1 week post vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,None,None,None,,NKDA,"['Dermatitis', 'Erythema', 'Injection site pain', 'Injection site warmth', 'Myositis']",UNK,MODERNA, 923480,IN,19.0,F,"Headache, body ache, nausea, diarrhea, cold sweats, fever Still experiencing these",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,,,,,"Bactrim, curry","['Cold sweat', 'Diarrhoea', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 923481,TX,60.0,F,"Itchy, raised rash at injection site that occurred 7 days after vaccine received. Took 25 mg of Benadryl, applied OTC cortisone cream to area, took 1000mg acteaminophen, took 1 low dose aspirin. Became less itchy for about 5 hours then became itchy again. Rash still at site, had not spread. Took 25 mg Benadryl, applied OTC cortisone cream to area.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,"LOSARTAN, HYDROCHLOROTHIAZIDE, CRESTOR, OMEPRAZOLE, SENNA AIRBORNE, VITAMIN D, ZINC, MELATONIN",NONE,HIGH BLOOD PRESSURE,,PENICILLIN,"['Injection site rash', 'Rash papular', 'Rash pruritic']",1,MODERNA,IM 923482,WA,30.0,M,"Severe arm pain at injection site, slightly feverish, various body aches with various intensities and extreme exhaustion.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Fatigue', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 923484,,53.0,F,"Moderna COVID-19 Vaccine EUA Initial response injection site symptoms (redness, warmth, itching, swelling, pain) were slowly dissipating. Approaching 1 wk after vaccination, however, itching increased, followed by a marked erythemal response that continues to advance, along w/return of warmth.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,UNK,Daily multi-vitamin OTC,None,None,,Nausea to codeine,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 923485,TX,36.0,F,"Upper arm has a red raised rash the size of a fist, injection site hot and hard to touch, itching, intermittent arm numbness/tingling. All symptoms persisting for over a week even with taking antihistamines.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,none,none,none,,"Novocain, epinephrine","['Hypoaesthesia', 'Injection site induration', 'Injection site warmth', 'Paraesthesia', 'Rash erythematous', 'Rash papular']",1,MODERNA,SYR 923486,IN,55.0,M,"you don't make reporting this easy. i had to search for a method of reporting. I had a degree of fever, body aches, joint pain and headache for about 12 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,Vit D,none,none,,Asprin,"['Arthralgia', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 923487,GA,28.0,F,"""I received my first dose of the covid vaccine yesterday, January 4th around 3pm. I have not felt any major symptoms or side effects aside from pain at the injection site. This afternoon I noticed how sore my arm was and started looking up potential side effects of the vaccine to see how long I should expect pain. I was trying to practice lifting my sore arm and then started feeling light headed. My vision went blurry, my hearing was muffled, and I started to feel like I was going to faint and/or vomit. I tried drinking water to see if that would help and when it didn't I called over to my coworker to tell her I felt like I was going to pass out. She informed our boss, who called Employee Health. They both walked me downstairs to Employee Health.""",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Dizziness', 'Hypoacusis', 'Injection site pain', 'Vision blurred', 'Vomiting']",1,MODERNA,IM 923488,KY,37.0,F,"Large softball size knot at the injection site for over 48 hours. Site is hot to touch, red, and sore to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Sulfasalazine, plaquenil, adderall, Prozac",,Rheumatoid Arthritis seropositive,Fever and flu like symptoms after Dtap as a child,Duracef,"['Injection site erythema', 'Injection site nodule', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 923490,CA,46.0,F,"Waited on site for 15 minutes per instructions. Reaction occurred offsite 25 minutes after injection. Sudden onset dizziness, nausea, tickle/scratchiness in throat followed by audible stridor. Had taken vistaril 50 mg at time of injection...added 50mg Benadryl, steroid and Pepcid. Medications resolved symptoms, did not go to ER. Notified my allergist and have appointment scheduled for 1/25 to discuss reaction and whether second dose is advisable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,"Cromolyn, Pepcid, Zyrtec, montelukast, albuterol, vitamin d, vitamin c, zinc, Thrive",None,"Asthma, ideopathic angioedema",,"NKDA, had reactions to some meds and tested positive for food allergies in the past but have since taken with no reactions.","['Dizziness', 'Nausea', 'Oropharyngeal discomfort', 'Stridor']",1,MODERNA,IM 923491,IN,52.0,F,"I began itching horribly on my face, neck and chest",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/04/2021,3.0,UNK,Estradiol Valacyclovir Fenofibrate Gabapentin Lisinopril,,,,Flagyl Penicillin Cefdinir Ciprofloxacin Phenazopyridine Sulfamethoxazole Macrodantin,['Pruritus'],1,MODERNA,SYR 923492,TX,38.0,M,"INITIAL SYMPTOMS INCLUDED ITCHING, REDNESS, BUMPS, TINGLING TO LEFT EAR. PROGRESSED TO RIGHT EAR JAN.01 2021 WITH ""SKIN FLAKING"" TO BOTH EARS. JAN 01 2021, EYE IRRITATION, ITCHING TO FACE AND EYES, ""FEELS DRY AND IRRITATED"". SYMPTOMS OPNGOING AT TIME OF REPORT. PT ABLE TO RETURN TO WORK.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,NONE,NONE,NONE,,NONE,"['Abnormal sensation in eye', 'Erythema', 'Eye irritation', 'Eye pruritus', 'Paraesthesia', 'Pruritus', 'Rash', 'Skin exfoliation']",UNK,MODERNA,IM 923493,IN,31.0,F,Fever ranging from 100.0 - 102.6,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,WRK,,,,,,['Pyrexia'],1,MODERNA,SYR 923494,IL,50.0,F,"1) on 01/04/21, around 1:30 pm received vaccine to left arm, 2) 01/05/21, around 4 am, woke up with headache, sore throat, temp 99.1, left arm slight numbness and tingling 3) 01/05/21, 6am, symptoms worsening, temp 100.1, severe body ache, headache, sore throat, chills, nausea, diarrhea,severe weakness, left arm more numb and tingling. Symptoms were consistent and as severe as covid infection that I experienced in August,2020. On 01/05/21 tested negative for covid and flu ( tested at nursing facility where I work) Today, 01/06/21, I'm still bed resting, no fever today, and less headache and body ache. Left arm is just sore- no numbness or tingling. I do realize that most of these symptoms are listed under side effects, but my side effects are as intense as my covid infection. Beck in August, last year, I couldn't get out of the bed for 8 days, due to aches, and all the other mentioned symptoms ( except arm problems). I was not hospitalized, but I was never that sick in my life. Based on severity of reaction to vaccine, I'm not planning to take second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,"Aspirin 81 mg, multivitamins",Heart palpitations,"Arthritis, enlarged liver and kidney cysts",,Nka,"['Asthenia', 'Body temperature increased', 'Chills', 'Diarrhoea', 'Headache', 'Hypoaesthesia', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Paraesthesia', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 923495,WA,30.0,M,"Severe arm pain, slightly feverish, various body aches with various intensities and extreme exhaustion.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Fatigue', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 923496,IL,49.0,F,"Day of next day after vaccine administration-only had mild headache, thirst and fatigued. I did have a hematoma and bruising, No fever On Jan 1st, I started feeling fatigued again and noticed round reddening approximately 2 inch in diameter appear about a inch under vaccination location which is still bruised. There is no pain or itching at reddened site. Jan 2, 3 and 4th-Fatigue worsened and developed low grade temp never surpassing 100. My throat developed allergy reaction feeling, same reaction I get with nuts. Throat did not swell and benedryl managed the reaction on Jan 3rd. My eyes began swelling and I could not stop sneezing. Developed laryngitis from the post nasal drainage. I was up whole night but still went into work as normal on Jan 4th. Struggled through the days but swelling and itching subsided. I experienced the muscle aches on the 3rd and 4th. On Jan 5th, started feeling better and rested. Still have reddened reaction on arm but is fading. It is faintly visible today on Jan 6th, I feel better, just have the sneezing currently and a mild headache. Benedryl is the only medication besides daily meds I took during the past several days. I did not want to interrupt the immune system's work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,01/01/2021,13.0,WRK,Carvedilol Dyazide Estradol Omeprazole Claritin Fish oil Iron Vitamin mix Calcium with Vit D probiotic flonase-prn Albuterol-prn,none besides GERD,GERD Menopause hip arthritis-had hip replaced 7/2019 high blood pressure-well maintained with medication allergy induced asthma,,"Nuts-anaphylaxis Azythromycin-hives Latex-hives Dermabond-system reaction-airway did not swell but eyes did Multiple environment allergies, Pine trees, eucalyptus, strong perfumes make airway react","['Body temperature increased', 'Contusion', 'Eye swelling', 'Fatigue', 'Haematoma', 'Headache', 'Hypersensitivity', 'Injection site bruising', 'Injection site erythema', 'Laryngitis', 'Myalgia', 'Sinus operation', 'Sleep disorder', 'Sneezing', 'Thirst']",UNK,PFIZER\BIONTECH,IM 923497,AZ,44.0,F,"immediately after, pt reports felt lightheaded, anxiety, jittery, and fatigue, reports increased dizziness/jittery/fatigue 2nd day, and continued sxs including development of headache day 5, felt like ""I had low blood sugar""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,none,morning of -> sore throat,GDM with last pregnancy,,NKAs,"['Anxiety', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Feeling jittery', 'Headache', 'Immediate post-injection reaction']",1,MODERNA,IM 923499,NE,33.0,F,"Individual developed ""gello"" heavy legs and ""foggy"" heavy head, occurred 2-3 (4:00pm)hours after injection. no symptoms till than. lasted 2 hours (5:30) then legs were better and head heaviness lasted till 830 pm symptoms improve but today 1/6/2021 still has some fatigue, chest congestion and headache. Did find out she had exposure on Friday 1/1/2021 will get testing for Covid 19 today",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"vyvanse , lamectal, Claritin, Xanax had dose that day","anxiety ,",anxiety,,"sulfa, cipro","['Fatigue', 'Feeling abnormal', 'Head discomfort', 'Headache', 'Limb discomfort', 'Pulmonary congestion', 'SARS-CoV-2 test']",1,MODERNA,IM 923500,ID,40.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/31/2020,3.0,PVT,,,,,,['Headache'],1,MODERNA,IM 923503,CA,43.0,F,5minutes post injection. I had Sour taste of medicine in back of throat. Couple minutes later. Felt throat swell. Not lymph nodes. Swelling sensation Inside throat. Had a mild headache. Was given 50mg of Benadryl. Taken to ER for observation. Swelling resolved couple hours later without any further reactions. Swelling never impeded my ability to breathe.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/21/2020,20.0,PVT,,,,,Latex,"['Dysgeusia', 'Headache', 'Pharyngeal swelling']",1,PFIZER\BIONTECH,SYR 923504,MI,34.0,F,"Numb roof of mouth, tingling tongue and lips; no medications given; patient transferred to ED",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,,,,,NKDA,"['Hypoaesthesia oral', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 923505,MI,35.0,F,"Left side numbness of face including cheek, lips forehead and chin area all on left side of face",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,SEN,Motrin 200,,,flu shot/ hives,"penicillin, sulfa , doxycline","['Hypoaesthesia', 'Hypoaesthesia oral']",UNK,MODERNA, 923506,TX,37.0,M,"he had some facial drooping then resolving and his hand released an object he was holding, limbs going numb and he felt like he was having a stroke. This occurred about an hour after his vaccine. in the next few days he experienced severe headaches. All adverse experiences have resolved as of 1/6",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,none,none,none,,nka,"['Facial paralysis', 'Feeling abnormal', 'Grip strength decreased', 'Headache', 'Hypoaesthesia']",UNK,PFIZER\BIONTECH,IM 923507,OH,30.0,F,I experienced arm soreness at the injection site immediately after. Fatigued two days afterwards. Also experienced Hixton Braxton contractions after the injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,UNK,Pre-natal vitamins,DtaP injection (got a headache right after the injection),"Anxiety, IBS (no affecting participant at the moment)","headaches, pain to the injection site",Intolerance Jasmine tea,"['Fatigue', 'Immediate post-injection reaction', 'Injection site pain', 'Uterine contractions during pregnancy']",1,MODERNA,SYR 923508,ID,46.0,F,Headache and Nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/02/2021,5.0,PVT,,,,,,"['Headache', 'Nausea']",1,MODERNA,IM 923509,CA,36.0,F,chills fever felt off body aches hives over stomach pounding headache lethargic,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,,,,,,"['Chills', 'Feeling abnormal', 'Headache', 'Pain', 'Pyrexia', 'Urticaria']",1,MODERNA,SYR 923510,TN,85.0,M,"PATIENT SPOUSE REPORTS THAT PATIENT RECEIVED VACCINE ON 1/4/2021 AND ON 1/5/2021 PATIENT'S ARM BEGAN TO TURN RED AND SWELL AT THE INJECTION SITE. THE SWELLING AND REDNESS BEGAN TO GO DOWN HIS ARM AND HE BROKE OUT INTO A RASH. PATIENT THEN BECAME SHORT OF BREATH. EMS WAS CALLED AND PATIENT WAS TRANSPORTED TO HOSPITAL, WHERE HE WAS TREATED FOR ANAPHYLACTIC SHOCK TO THE COVID MODERNA VACCINE.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/04/2021,01/05/2021,1.0,PUB,UNKNOWN,UNKNOWN,UNKNOWN,,PCN,"['Anaphylactic shock', 'Dyspnoea', 'Erythema', 'Injection site erythema', 'Injection site swelling', 'Peripheral swelling', 'Rash']",1,MODERNA,IM 923511,MN,27.0,F,"Headache, nausea/vomiting, chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 923512,IN,65.0,M,"Fever of 100.4, chills, aches, malaise, lethargy, muscle weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Trazadone 50 mg 1x daily, Advil PM, Tamsulisin 0.4 mg 1x daily",None,Obesity,,None,"['Chills', 'Lethargy', 'Malaise', 'Muscular weakness', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,MODERNA,IM 923513,CA,37.0,F,"dizziness, chills, nausea and vomiting, headache, weakness and pain in the arm/injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,on birth control pills,no,no,,unknown,"['Asthenia', 'Chills', 'Dizziness', 'Headache', 'Injection site pain', 'Nausea', 'Pain in extremity', 'Vomiting']",1,MODERNA,IM 923514,PA,27.0,F,"WITHIN THE SAME DAY STARTED WITH RIGHT ARM SWELLING, REDNESS, WARMTH, AND ITCHING AT INJECTION SITE. TAKING IBUPROFEN AND ICED AREA. GOT BETTER AFTER A FEW DAYS AND STARTED BACK UP AGAIN, WORSE THAN BEFORE.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,NUVARING,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth', 'Peripheral swelling']",1,MODERNA,IM 923517,,55.0,F,"Rash, chest pain, tachycardia, numb tongue, hard to swallow",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,sensitivity to narcotics,,,"['Chest pain', 'Dysphagia', 'Hypoaesthesia oral', 'Rash', 'Tachycardia']",UNK,PFIZER\BIONTECH,IM 923518,ME,63.0,F,right axillary lymphadenopathy,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,not known,no,no,,no,['Lymphadenopathy'],1,MODERNA,IM 923519,IN,37.0,F,Queasy and cold chills,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Chills', 'Nausea']",UNK,PFIZER\BIONTECH,SYR 923520,IN,25.0,F,Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,,,,,,['Pyrexia'],1,MODERNA,IM 923521,MT,50.0,F,"Dizziness, Elevated",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 923522,WI,51.0,F,"Extreme erythema and edema across entire Left shoulder, approx. 5 inches from shoulder joint, 3 1/2 x 2 1/2, with extreme itching. It was reported that small amount of redness at injection site was noted 2 days after the injection, that later resolved, and noted itching at the site on 01/03/2021, and noted the extreme redness, with increased itching on early morning of 01/06/2021 at 4:40am. MD appointment is pending.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,PVT,"Blood Pressure medication( Metroprolol); Hypothyroidism Medication, and Cholesterol reducing medication",,"Hypertension, Hypothyroidism and Hypercholesterolemia",,Penicillin,"['Injection site erythema', 'Injection site pruritus', 'Oedema']",1,MODERNA,IM 923523,AZ,53.0,F,"Moderna COVID-19 Vaccine EUA Initial injection site symptoms (itching, redness, warmth, swelling, pain) were slowly dissipating. Approaching 1 wk post injection, however, the itching increased and the next morning (1/5/21), a marked erythemal response began, which continues to advance, along with increased warmth. I've also begun to experience temperature swings between hot/cold (as of 1/5/21).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,Daily multi-vitamin,None,None,,Nausea to codeine,"['Feeling of body temperature change', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 923524,IN,43.0,F,"extreme headache with sensitivity to light, low grade fever (99.8), large muscle body ache, fatigue lasted from around 2am 1/6 until 5pm 1/6.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Lexapro 20mg Protonix 40mg,Positive COVID result 11/29/2020,GERD,,nka,"['Fatigue', 'Headache', 'Photophobia', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 923525,TX,73.0,F,"Day/night 1, no problem. Day 2 - soreness in arm around injection site. Only felt soreness when touched. Night 2 - had long-sleeve t-shirt on all day, so didn't notice the large red area until nighttime. Also same area had swelling/hardness that was sore. Day 3 - morning - redness/swelling still evident.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PUB,"600mg Calcium, 4000IU Vitamin D, 5000mcg Biotin, 500mg Rutin, 1000mg Fish Oil, 400mg Magnesium, 2500mcg B12(every other day)",,20+ year Breast Cancer Survivor (8/18/2000),,,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling']",1,MODERNA,SYR 923526,WV,33.0,F,"Erythema, swelling, warmth to the site (5in x 2.5in) sore lymph nodes (axillary, cervical, tonsil)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/01/2021,9.0,PVT,"NPH, metformin, ozempic",,Diabetes Type 2,"Influenza vaccination, 11/02/2020, sanofi, 33y, erythema, swelling, warmth","mobic, trulicity","['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Lymph node pain']",1,MODERNA,SYR 923527,TX,29.0,M,"Moderna COVID-19 Vaccine EUA. Rather moderate joint soreness, Chills, body aches, slight fever.It all started the night of the vaccine with the soreness at the injection site (1/5/21). Then the next morning I was riding in my car (1/6/21 around 9:45am) and a weird virtigo feeling settled in. After that was when the chills started with the body aches. I checked my temperature before I went in to the shower and it was running 99.7. Then when I was showering I had that uncomfortable feeling when the water hits you right before you get sick. Kind of a werid feeling to describe if you've never experienced it before. I have just been monitoring my symptoms and staying home, and hydrating.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,Finasteride 1mg: qd; JOCKO JointWARFARE: 4c po qd; Acidophilus,,"Seasonal Asthma, Seasonal Allergies",,,"['Arthralgia', 'Chills', 'Feeling abnormal', 'Injection site pain', 'Pain', 'Pyrexia', 'Vertigo']",1,MODERNA,IM 923528,IN,31.0,F,"Low grade fever between 99 and 100 lasting 24 hours the day following vaccination, injection site reaction (moderate arm soreness starting 4 hours after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PUB,"Zyrtec, montelukast, qvar, lillow, omepraxile, azelastine, fluticasone",Flu 2-3 weeks prior (COVID test negative),"Allergies, asthma, platelet defect, neurocardiogenic syncope",,Benzocaine,"['Injection site reaction', 'Limb discomfort', 'Pyrexia']",UNK,MODERNA, 923529,CA,37.0,F,First 2 days had redness and swelling at injection site. 5 days later left arm pit was in pain. It was extremely painful to move my arm or touch. I didnt think it was related to the vaccine. I just thought it was a muscle strain but now i have lump under my arm pit. I believe this is lymphadenopathy.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/01/2021,5.0,WRK,Multivitamin,None,None,,Compazine,"['Axillary pain', 'Injection site erythema', 'Injection site swelling', 'Nodule', 'Pain']",1,MODERNA,SYR 923530,WA,49.0,F,"moderna COVID-19 Vaccine EUA. Tachycardia sudden onset 4 minutes after injection (6:09am). Arms and legs cold and weak. Generalized weakness. BP 167/78, o2 sats 100%. Tachycardia lasted about 10-15minutes and resolved to HR 88 and BP 138/78. Still left with overall weakness, malaise, cold feeling. No other symptoms. Released from the facility at 6:48am. Drove 2 blocks to my husband's workplace (hospital). Had diarrhea x 2, dull diffuse headache, odd feeling and malaise that persisted. Sudden onset of terrible feeling, the need to get to the ER at 8:36am. Had a bathroom visit to urinate. By the time we got to the ER the intense malaise improved. I sat in the ER lobby not wanting to be admitted to the ER (didn't want to be having a vaccine reaction). I stayed in the ER lobby. Symptoms completely resolved at 9:45am. I stayed there for 30 more minutes to be sure and then drove home with no other symptoms but Left arm soreness. Tachycardia never returned after the first episode. No rash, no itching, no swelling, no dyspnea. Just felt toxic. Then it resolved completely at hour 4.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,none. Mirena IUD,None,"Mitral Regurgitation, Left Atrial Enlargement Moderate due to MVP. Nephrolithiasis. Migraine with Aura.",,None,"['Asthenia', 'Diarrhoea', 'Feeling abnormal', 'Feeling cold', 'Headache', 'Malaise', 'Muscular weakness', 'Pain in extremity', 'Peripheral coldness', 'Tachycardia']",1,MODERNA,IM 923531,NJ,45.0,F,"COVID toes and fingers, with itchy and painful nodules on fingers, feet",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/04/2021,8.0,PVT,"Wellbutrin, levothyroxine, Deplin, vitamin D, fish oil",no,no,,none,"['Nodule', 'Pruritus', 'SARS-CoV-2 test negative']",1,MODERNA,IM 923532,NC,44.0,F,developed nausea right after taking vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/16/2020,12/16/2020,0.0,PVT,,,,,,['Nausea'],1,PFIZER\BIONTECH,IM 923549,,62.0,M,"Headache, Myalgia, Anaphylaxis, Fever, HYPERtension, oral thrush Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,OTH,,,,,,"['Anaphylactic reaction', 'Headache', 'Hypertension', 'Myalgia', 'Oral candidiasis', 'Pyrexia']",UNK,MODERNA, 923562,FL,,F,"Suspected vaccination failure / have gotten the Shingrix shot / Since having / Shingrix series / continues to have shingles outbreaks; have shingles for over 20 yrs have gotten outbreak now / has the shingles outbreaks at least twice a year; she does get blisters; blisters / they do itch; blisters/ are painful; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (for over 20 yrs). Previously administered products included Zostavax. On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister, pruritus and pain. On an unknown date, the outcome of the vaccination failure, blister, pruritus and pain were unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, blister, pruritus and pain to be related to Shingrix and Shingrix. Additional details were provided as follows: The case was repored by patient herself. The patient had the Shingrix 2-dose series in 2018. Since having the Shingrix series, she continued to have shingles outbreaks. She had the shingles outbreaks at least twice a year. She stated they were not as severe as they were prior to being vaccinated with Shingrix but she did get blisters and they do itch and were painful. They were treated with (unspecified) antiviral prescription medications. She usually goes to urgent care when she had an outbreak. She tried to go to urgent care as soon as the symptoms begin but with her last outbreak she was hesitant to go to the urgent care due to the Covid-19 epidemic and so she waited over a week to go and due to that her outbreak lasted 3 weeks. The patient was calling to see if she could receive a third dose of Shingrix. She states that her shingles outbreaks were triggered by stress such as the stress of wearing a mask while at the gym. The patient was currently on an anti-viral drug being have gotten outbreak now. Also yearly, the patient get the shingles minimum of 2 times a year and need to take the anti-viral drug. This case was considered as suspected vaccination failure since the details regarding laboratory test were unknown at the time of reporting.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: Shingles (for over 20 yrs),,,"['Blister', 'Herpes zoster', 'Pain', 'Pruritus', 'Stress', 'Vaccination failure']",2,GLAXOSMITHKLINE BIOLOGICALS, 923563,,,U,"suspected vaccination failure; whooping cough; lose my breath; asthma; did not feel well; cough.; sick; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant), apnea (serious criteria GSK medically significant), asthma, sickness, malaise and cough. The patient was treated with anti-asthmatic (nos) (Asthma Medicines (Nos)). On an unknown date, the outcome of the vaccination failure, whooping cough, apnea and asthma were unknown and the outcome of the sickness and malaise were recovered/resolved and the outcome of the cough was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, whooping cough, apnea, asthma, sickness, malaise and cough to be related to Tdap Vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient received TDAP vaccine in 2016. The patient experinced whooping cough two years ago from the day of reporting The patient had developed asthma after over whooping cough The patient had coughed every day for over two years The patient lose breath when talk a lot (which patient normally do not do). The patient waas sick for 5 months and I did not feel well until months after that. At the time of reporting felt better. The patient's pulmonologist upped the asthma medicine and still patient had cough.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Apnoea', 'Asthma', 'Cough', 'Dyspnoea', 'Illness', 'Malaise', 'Pertussis', 'Vaccination failure']",UNK,UNKNOWN MANUFACTURER, 923564,NJ,,M,"covid; covid; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. The physician inquired whether a person with previous history of COVID would experience more significant reaction to the COVID vaccine than a person without a previous diagnosis due to having already produced antibodies. Reporter's colleague (physician) had the vaccine 2 weeks ago, had a severe reaction (unspecified) wherein he got a shot of epi. Patient recovered and was okay. At the time of reporting, patient now had Covid or maybe he had Covid before, reporter was not sure. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 vaccine cannot be completely excluded for event ""Covid"".",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['COVID-19'],UNK,PFIZER\BIONTECH, 923565,PA,54.0,F,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms, tested for COVID (PCR); night sweats; Soreness at injection site; slight temp 99.5 degrees/her temperature was 101 degrees Fahrenheit/it was 102.5 degrees Fahrenheit/99 degrees Fahrenheit and then 98 degrees Fahrenheit; Tiredness she related to giving blood; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via intramuscular on 19Dec2020 15:45 on left deltoid at a single dose for prevention as frontline health worker at hospital (COVID-19 immunisation). The patient donated blood on 18th and no antibodies were present then. The patient was a former smoker and quit 2 or 3 years ago. Patient diagnosed Osteoporosis in 2015, benign heart arrhythmia in 2005. The patient took 70 mg alendronate sodium (FOSAMAX) once weekly and just a regular OTC daily multivitamin. Caller reported she was having the covid vaccine on 19Dec2020 and began having fever, night sweats, loss of taste and smell and then tested positive for covid. The patient received the Pfizer COVID 19 vaccine through work on 19Dec2020. She received it at 3:45 pm and should have taken temperature before, but she was afebrile the day before because she donated blood. At 7pm, she had slight temp 99.5 degrees Fahrenheit and by 10:30, her temperature was 101 degrees Fahrenheit and she still felt fine. She was surprised that it was that. She woke up at 2:30 am on 20Dec2020 and took her temperature and it was 102.5 degrees Fahrenheit. She took 2 Tylenol and went back to bed and felt fine. By morning it was 99 degrees Fahrenheit and then 98 degrees Fahrenheit a little later. She has been afebrile since then. She was a little tired because she gave blood and though it was related. She does not know if it was a side effect or not. It was not significant tiredness and was just not having energy in the evening of 19Dec2020. She also had soreness at injection site that night after 22:00 and the next day. It did not bother her until she woke up in the middle of night, and she noticed her left arm was sore. She received the vaccine at 3:45pm and started with low grade fever at 6:30 pm, earlier stated at 7:00 pm. There was no prescriber. She tested for COVID (PCR) on Saturday, 26Dec2020 at 14:50and it came back positive 28Dec2020 18:45. At 10pm on 19Dec2020, her temperature was 101 degrees Fahrenheit. If she had not been monitoring her temperature, she would not have known. She has been Afebrile since morning of 20Dec2020. Tiredness she related to giving blood and the holidays. She was a little stressed about the holidays and running around. It was very mild. Soreness at injection site was during the night after 10pm when she went to bed. On Wednesday, 23Dec2020, she woke up congested, sniffly, sneezy, with a runny nose. This persisted through Wednesday night. Her sense of taste was off. She had no problem with that on Tuesday. She had some horrible smell at work she recalled, so she knew her sense of smell was fine. On Thursday, 24Dec2020, she had no sense of taste or smell. She could not smell a pine candle. She was congested on Thursday and called employee health on 24Dec2020. This both improved and persisted. She is still congested but it has improved. She has never had a complete loss of sense of taste or smell before. Mild cough started yesterday morning. On the night of 20Dec2020, and 21Dec2020, she developed night sweats. She had not had any night sweats before this since menopause and she woke up really wet. The patient was not hospitalized and not admitted to an Intensive Care Unit. NO ER or physician's office required. She did not know if she was exposed on the day of the vaccine or if a couple of days later if the fever is from the vaccine. She stated what are the chances she goes 10 months and is super careful and then gets the vaccine and test positive. The patient did not display clinical signs at rest indicative of sever systemic illness. The patient did not require supplemental oxygen nor receive mechanical ventilation. No Multiorgan failure. The patient did not receive any additional therapies for COVID- 19. No initiation of new medication or other treatment or procedure. Not any preexisting diseases worsen during the SARS-CoV2 infection. She would like to know if there is a chance of false positive for this. It would just be her luck to be 10 months and not getting it. She has not gone anywhere without her N95 and then gets the vaccine and gets COVD. She wears mask and face shield at work always. She also wanted to know if she should get the second dose. The outcome of the event slight temperature was recovered on 20Dec2020 and the other event was recovering.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/19/2020,0.0,PVT,FOSAMAX,,Medical History/Concurrent Conditions: Arrhythmia; Blood donation (no antibodies were present then.); Osteoporosis; Smoker (Quit 2-3 years ago.),,,"['Ageusia', 'Anosmia', 'Asthenia', 'Cough', 'Fatigue', 'Hyperhidrosis', 'Injection site pain', 'Night sweats', 'Pain in extremity', 'Pyrexia', 'Respiratory tract congestion', 'Rhinorrhoea', 'SARS-CoV-2 test positive', 'Sneezing', 'Stress']",1,PFIZER\BIONTECH,OT 923566,AZ,39.0,M,"tested positive for Covid two days after getting vaccine; tested positive for Covid two days after getting vaccine/nasal swab/ NP PCR and result was positive; This is a spontaneous report from a contactable physician. A 39-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), intramuscular on the left arm on 24Dec2020 at 08:30 at a single dose for Covid-19 immunization. There were no medical history and no concomitant medications. The patient has no known allergies to medications, food, or other products. On 25Dec2020 at 09:00 am, also reported as 26Dec2020, the patient was tested positive for Covid two days after getting vaccine. He was wondering if he should get the booster dose in 3 weeks or not since he will have natural immunity. The patient did not receive any treatment for the events. The patient had a nasal swab/ NP PCR and result was positive on 26Dec2020. The outcome of the events was not recovering. The events were assessed as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the COVID-19 PCR test positive represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/01/2020,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH,OT 923567,NV,29.0,F,"left supraclavicular lymph adenopathy; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899) intramuscular on 16Dec2020 14:00 (02:00 PM) at a single dose on the left arm as COVID-19 vaccine. The patient had no medical history/concurrent conditions and no known allergies to medications, food, or other products. Concomitant medication included paracetamol (TYLENOL) (received within 2 weeks of vaccination). The patient had an adverse event (AE) left supraclavicular lymph adenopathy on 23Dec2020 which resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment for the AE included antibiotics. It did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. She was not pregnant at the time of vaccination. She did not receive other vaccines within four weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination and did not have Covid tested post vaccination (had not been tested for COVID-19 since the vaccination). The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/23/2020,7.0,PVT,TYLENOL,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Lymphadenopathy'],1,PFIZER\BIONTECH,OT 923568,,,F,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable unspecified HCP reporting for herself. This 61-year-old female patient received on 22Dec2020 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 24Dec2020, the patient had a bad reaction, coughing, headache, no taste, tiredness and body aches. The patient thought originally, she was having a reaction to the vaccine, and took some ibuprofen (ADVIL). The patient was still congested and was sent for testing. She was tested positive on 28Dec2020. The test was a nasal swab. Outcome was unknown. The patient was wondering if this was part of the side of effect of the vaccine. Information on the batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/24/2020,2.0,UNK,,,,,,"['Ageusia', 'Cough', 'Fatigue', 'Headache', 'Pain', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 923569,MN,58.0,F,"injection site tenderness/it is a little tender; swollen at injection site/It is swollen at the injection site; itchiness at injection site; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (upper left arm) on 21Dec2020 (between 9:00AM and 9:30AM) at single dose for Covid-19 immunization. Medical history included allergic to dust mites and grass, summertime allergies (haven't been diagnosed but she has sneezing and watery eyes during the summer), obese at 190, and flu vaccine in Oct2020, and smoker. Her mother passed from COPD and stated that more than likely she has that because she is a smoker. Her father had congestive heart failure. Concomitant medications were not reported. The patient previously took flu vaccine vii and experienced migraine; also, previously took Novocaine (probably 10 to 15 years ago) out of the blue she had a reaction. ""Eons ago"" when she was probably 25 she had a reaction to the very first flu shot that she got. The reaction was a migraine and she could not get out of bed. The patient wanted to know if it was normal to have side effects a week later after receiving Covid vaccine. She received vaccine on 21Dec2020 and today (29Dec2020 5AM) she was experiencing injection site tenderness, appearing swollen at injection site, and itchiness at injection site. It was further reported that she woke up this morning and her arm is itchy. It is swollen at the injection site. It is about the size of a fifty-cent piece. It is itchy and it is a little tender. The patient added, ""It is a little tender"": it was a little sore the first day like a flu shot. It is annoying like a bug bite itch. The swelling has been the same throughout the day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was not recovered. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/29/2020,8.0,PVT,,,Medical History/Concurrent Conditions: Congestive heart failure (father); COPD (mother); Dust allergy (summertime allergies); Flu vaccination; Grass allergy; Obesity; Seasonal allergy (haven't been diagnosed but she has sneezing and watery eyes during the summer); Smoker,,,"['Vaccination site pain', 'Vaccination site pruritus', 'Vaccination site swelling']",UNK,PFIZER\BIONTECH, 923570,,,U,"got the COVID-19 vaccine last week and six days later tested positive for COVID-19; got the COVID-19 vaccine last week and six days later tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on unspecified date in Dec2020 at single dose, for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the covid-19 vaccine last week and six days later (Dec2020) tested positive for Covid-19. The outcome of event was unknown. Information about Lot/Batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 923571,CO,,F,"breathlessness; racing heart rate; shaking disease; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 27Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Dec2020, the patient had an immediate reaction which included breathlessness, racing heart rate, and ""shaking disease."" She said that the reactions happened a minute after getting the vaccine. She was observed for an hour and said she still had the breathlessness, but was improving. She wanted to know if she should still take the second dose of the vaccine. Outcome of the event breathlessness was recovering, while for the other events was unknown. Information about the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,UNK,,,,,,"['Dyspnoea', 'Palpitations', 'Tremor']",1,PFIZER\BIONTECH, 923572,CA,40.0,F,"anaphylaxis; ALOC/decreased level of consciousness; This is a spontaneous report from a contactable Pharmacist (patient). a 40-year-old female patient (no pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140) via intramuscular at Left arm on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history included known allergies to egg, seafood, azithromycin, orange and seasonal allergies. The concomitant was reported as cetirizine hydrochloride (ALLERTEC) and PRN 1371. The patient with no known past medical history brought in by CODE Team to RUH ED with concern for ALOC after getting the COVID vaccination 30-40 minutes PTA. Patient was a nurse and experienced decreased level of consciousness following her COVID vaccination. Patient reports h/o anaphylaxis. She was given epinephrine PTA. Denies SOB, oral swelling, CP. Blood glucose (BGL) within normal limits. Patient denies any other complaints or symptoms at this time. Adverse event start date: 23Dec2020. Treatment was unknown for decreased level of consciousness. The outcome of the events was recovered in Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis /decreased level of consciousness cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,ALLERTEC;,,Medical History/Concurrent Conditions: Food allergy; Seasonal allergy,,,"['Blood glucose normal', 'Depressed level of consciousness']",1,PFIZER\BIONTECH,OT 923573,AZ,,F,"She has been feeling rotten for a few days; This is a spontaneous report from a Pfizer-sponsored program via a contactable physician reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included ongoing COVID positive since 22Dec2020. She was COVID positive before she got the vaccine. She got tested for COVID Corona Virus, because they do it weekly. She does weekly self-testing as part of a study she is in. There was an outbreak at her office and that is why she had to get a whole other test. On 22Dec2020 she did a nasal swab. She didn't get the results from the nasal swab until the day of report. The patient's concomitant medications were not reported. It was reported she was having an immune reaction to the vaccine and she was expecting it and said it was ok. On the 23rd she had symptoms. On the 24th, the rapid test was positive. The results from the nasal swab on 22Dec2020 was positive, so she was COVID positive before she got the vaccine. She has been feeling rotten for a few days and couldn't reach out before today. The patient wanted to know if it would be effective for her to receive the second dose of the COVID vaccine after being positive for the COVID virus. Outcome of the event was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/01/2020,,UNK,,COVID-19 virus test positive,,,,"['Malaise', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 923574,NV,43.0,F,"Elevated HR up to 130 for a few hrs after administration and intermittently for several days; Severe fatigue; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: eh9899, expiry date not reported), intramuscular on the left arm on 16Dec2020 12:00 at single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. On 16Dec2020 14:00, the patient experienced elevated HR up to 130 for a few hours after administration and intermittently for several days and severe fatigue. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered with sequelae on Dec2020. Follow-up attempts are not possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/16/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Asthma,,,"['Fatigue', 'Heart rate', 'Heart rate increased']",1,PFIZER\BIONTECH,OT 923575,WI,51.0,F,"caller couldn't hear properly; got the Covid vaccine last 18Dec2020/her second dose of COVID-19 Vaccine was scheduled on 06Jan2021; Caller got the Covid vaccine last 18Dec2020 and was tested positive, 29Dec2020; Caller got the Covid vaccine last 18Dec2020 and was tested positive, 29Dec2020; Nausea; Headache; Body aches; fatigue; Cold sweat; This is a spontaneous report from a contactable other health professional. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number reported as either EK5730, ER5730, or EX5730), via an unspecified route of administration on 18Dec2020 16:00 at single dose at left deltoid for COVID-19 immunisation. Medical history and concomitant medications were none. The patient previously had shingles shot in Sep2020, previous shingles shot either three months or six months prior to the one in Sep2020 (2020), both for immunization, and severe myalgia and fever that lasted for two days after the second shingles shot (adverse events followed prior vaccinations). It was reported that did a callback as caller couldn't hear properly. Caller got the Covid vaccine last 18Dec2020 and was tested positive, 29Dec2020. Want to know if it's safe for her to get the second dose. The patient received Pfizer COVID-19 Vaccine on 18Dec2020 at 16:00. Patient had a couple days worth of symptoms. Now patient had COVID. Patient believed most likely got COVID from her son who was home from college. She was in between dosages of COVID-19 Vaccine. Looked like from research her quarantine would be done on 05Jan2021 and her second dose of COVID-19 Vaccine was scheduled on 06Jan2021. Everything she had read stated if her symptoms were gone to go ahead and get the second COVID-19 Vaccine. Patient wanted to know if Pfizer was doing any studies regarding people who test positive for COVID after receiving the COVID-19 Vaccine. Not sure if Pfizer would be interested in doing antibody studies. Declined obtained COVID-19 Vaccine through work Clarified caller's days worth of symptoms as: Headache the same evening as vaccination. Body Aches: began overnight on 18Dec2020. Fatigue that lasted all week, began overnight on 18Dec2020. Cold sweats: Lasted two days and began overnight on 18Dec2020. Nausea: began on 21Dec2020, not sure if it was related to COVID-19 Vaccine or not. The reporter considered the events weren't serious, but felt like she was having an immunological response. Diagnosed with COVID Seriousness: As of now, not serious. Is having a recurrence of all of those same symptoms as the COVID-19 Vaccine and then some. Lot number provided from patient card. Stated she was unable read it accurately. would take picture in case Pfizer wanted it. Stated lot number was either EK5730, ER5730, or EX5730. A sample of the product was not available to be returned. Vaccination facility type was Hospital, not administered at military site. No additional vaccines administered on same date of Pfizer suspect. No adverse events required a visit to. No prior vaccinations received within 4 weeks. The outcome of the event ""Cold sweat"" was recovered on 20Dec2020. The outcome of the other events was unknown. The reported considered the events Headache, Body aches, fatigue, Cold sweat, Nausea were related to the suspect drugs. Information on the lot/batch number has been requested.; Sender's Comments: The reported COVID test positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['COVID-19', 'Cold sweat', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 923576,,,F,had her shot of Covid vaccine last (22Dec2020) 7 days and was tested positive on Dec2020; had her shot of Covid vaccine last (22Dec2020) 7 days and was tested positive on Dec2020; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at a single dose as Covid vaccine. Medical history and concomitant medications were not reported. It was reported that the patient had her shot of Covid vaccine last (22Dec2020) 7 days and was tested positive on Dec2020. She wanted to know if this was normal to get false positive results after getting the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/01/2020,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 923578,DE,,F,"Positive for Covid after receiving the vaccine; Positive for Covid after receiving the vaccine; This is a spontaneous report from a Pfizer Sponsored Program. This consumer reported similar event for two patients. This is the 2nd of 2 reports. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration on 22Dec2020 at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was positive for Covid after receiving the vaccine. It was reported that patient was positive and they were all in the breakroom without a mask. The patient (person that is positive) got the vaccine and got worse, so co-workers are thinking that she (patient) had the virus before getting the vaccine and just didn't have any symptoms. Outcome of the events was unknown. Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518090 same reporter/drug, similar event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,PVT,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 923579,MT,52.0,F,"Asymptotic positive rapid COVID test 12 days post vaccination. Close contact testing/Nasal Swab positive; Asymptotic positive rapid COVID test 12 days post vaccination. Close contact testing/Nasal Swab positive; This is a spontaneous report from a contactable Other HCP (patient). A 52-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscular in arm left on 17Dec2020 13:15 at single dose for COVID-19 immunisation. Medical history included seasonal allergies, depression and Allergies: Sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), cefixime (FLEXERIL), fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), omeprazole (PRILOSEC). The patient previously took pethidine hydrochloride (DEMEROL) and experienced 'allergies: Demerol', codeine and experienced 'allergies: codeine'. The patient experienced asymptotic positive rapid COVID test 12 days post vaccination. Close contact testing on 29Dec2020. The patient underwent lab tests and procedures which included [{covid test type post vaccination= Nasal Swab, covid test date=29Dec2020, covid test result= Positive}]. Facility type vaccine was workplace clinic. No treatment received for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/29/2020,12.0,WRK,ZOLOFT; FLEXERIL [CEFIXIME]; ADVAIR; SINGULAIR; PRILOSEC [OMEPRAZOLE],,Medical History/Concurrent Conditions: Depression; Seasonal allergy; Sulfonamide allergy,,,"['Asymptomatic COVID-19', 'SARS-CoV-2 test positive', 'Viral test positive']",1,PFIZER\BIONTECH,OT 923580,CA,55.0,M,"top of left hand red; top of left hand pain; uncomfortable to open left hand; left wrist swollen; left hand swollen/the top of his left hand was warm and red; regular shot pain in left shoulder; regular shot pain in left shoulder/ top left wrist pain; This is a spontaneous report from a contactable consumer(patient). A 55-year-old male patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration in left arm, on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were none. The patient stated that he got his Pfizer Covid vaccination on Tuesday last week on 22Dec2020. The patient had few days regular shot pain in left shoulder. The patient stated that on Thursday(24Dec2020) that he was okay but got on his wrist on same arm and top of hand swollen was painful to movement. The patient stated that the top of his left hand was warm and red on Saturday(26Dec2020). The patient experienced top of left hand pain and top left wrist pain on 26Dec2020. The patient stated that he got the Covid vaccination in his left arm. The patient stated that on Sunday that he made a clinic appointment and they sent him anti-inflammatories. The patient stated that now he was getting better. The patient was uncomfortable to open left hand 25Dec2020. The patient stated that the pain in his left shoulder resolved Thursday or Friday. The patient stated that he can see his hand muscles more defined now. The patient stated that he can stretch his left hand better than before. The patient stated that he had blood work in doctor in Oct2020. The outcome of the events""regular shot pain in left shoulder"" was recovered, of the event""top of left hand red"" was not recovered and of the other events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Arthralgia', 'Blood test', 'Erythema', 'Joint swelling', 'Limb discomfort', 'Pain in extremity', 'Peripheral swelling', 'Procedural pain']",UNK,PFIZER\BIONTECH, 923581,SC,46.0,F,"the patient experienced tongue swelling 9 hours after injection; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Arm Left from 28Dec2020 12:45 to 28Dec2020 12:45 as single dose for COVID-19 immunization. Medical history included allergy to Latex and depression. Concomitant medication included duloxetine hydrochloride (CYMBALTA). The patient previously took Percocet and experienced allergies. On 28Dec2020 at 09:45 PM, the patient experienced tongue swelling 9 hours after injection. The patient stated had this similar feeling or reaction after taking Percocet when she had her first child. The patient took Benadryl 25mg as treatment to the event. The outcome of the event was recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,CYMBALTA,,Medical History/Concurrent Conditions: Depression; Latex allergy,,,['Swollen tongue'],1,PFIZER\BIONTECH,OT 923582,MI,31.0,F,"8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; This is a spontaneous report from a contactable nurse (patient). A 32-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 0140), intramuscular in the right arm on 21Dec2020 15:00 at a single dose for COVID-19 immunization at the age of 31 years old at the workplace clinic. Medical history included asthma and seasonal allergies. Concomitant medications included fluticasone nasal spray, fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) inhaler, montelukast sodium (SINGULAIR), colecalciferol (VITAMIN D), salbutamol sulfate (ALBUTEROL), zinc and unspecified multivitamin. On 29Dec2020 16:00, 8 days after the vaccine, the patient had swelling at the injection site on her right arm, it is hot and painful. Also, the patient had pain in right fingers and lymph pain in axillary region. Outcome of the events was unknown. No treatment was given for the events. The events were assessed as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/29/2020,8.0,WRK,; BREO ELLIPTA; SINGULAIR; VITAMIN D; ALBUTEROL;,,Medical History/Concurrent Conditions: Asthma; Seasonal allergy,,,"['Lymph node pain', 'Pain in extremity', 'Vaccination site pain', 'Vaccination site swelling', 'Vaccination site warmth']",1,PFIZER\BIONTECH,OT 923583,,,U,"I got the Pfizer vaccine, the first shot; I tested positive for Covid; I got the Pfizer vaccine, the first shot; I tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Consumer stated, ""I had a question, I got the Pfizer vaccine, the first shot on the 18Dec but I tested positive for Covid on the 27Dec, so, my question is this and I asked my healthcare institution and they still haven't got back to me, so I just wanted to call you guys, what do I do about the second dose because I am scheduled to get the second dose net week?"" The outcome of event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/27/2020,9.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 923585,SC,,F,"Chills; Nauseated; my incision or the shot site is red and swollen and very sore; my incision or the shot site is red and swollen and very sore; my incision or the shot site is red and swollen and very sore; headache; This is a spontaneous report from a contactable consumer medical social worker in the emergency department (patient). A 24-year-old female patient received bnt162b2 (BNT162B2, Batch/lot # EK5730, Expiry Date Mar2021) intramuscularly at single dose in arm in Dec2020 about 12 hours ago before this report for Covid-19 immunisation, administered at the hospital that she work at. Medical history was none. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) daily for birth control. In Dec2020, about 10 hours after vaccination was received, the patient experienced chills, felt nauseated, her incision or the shot site is red and swollen and very sore and headache. No lab test performed. No treatment received. The outcome of headache was unknown of the other events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/01/2020,0.0,PVT,JUNEL FE,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Chills', 'Headache', 'Nausea', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",UNK,PFIZER\BIONTECH,OT 923586,VA,57.0,F,"got lightness in my head/I have been dizzy; Headache; This is a spontaneous report from a contactable consumer nurse assistant (patient). A 57-year-old female patient received bnt162b2 (BNT162B2, Batch/lot # EH9899) at single dose on 28Dec2020 for covid-19 immunisation, administered at the hospital she worked at. Medical history included cholesterol. The patient reported taking unspecified concomitant medications. The patient got lightness in my head, had been dizzy and experienced headache in Dec2020. No treatment received. The outcome of events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/01/2020,,PVT,,,Medical History/Concurrent Conditions: Cholesterol (Verbatim: Cholesterol),,,"['Dizziness', 'Headache']",UNK,PFIZER\BIONTECH, 923587,NC,27.0,F,"Cervical lymphadenopathy; Chills; Nausea; Feeling lightheaded; This is a spontaneous report from a contactable physician (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/4130421), via an unspecified route of administration on 29Dec2020 10:00 in left arm at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included linaclotide (LINZESS) and a combination birth control pill both received within 2 weeks of vaccination. On 29Dec2020 at 10:00 PM (22:00), the patient experienced chills, nausea, feeling lightheaded and cervical lymphadenopathy. The symptoms were severe enough that the patient needed to leave work in the middle of her shift (primarily due to the lightheadedness). The patient tried drinking juice, water, etc but it kept getting worse so after a few hours the patient decided she needed to leave work. The patient did not received treatment for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,LINZESS,,,,,"['Chills', 'Dizziness', 'Lymphadenopathy', 'Nausea']",1,PFIZER\BIONTECH, 923588,WI,35.0,M,"body aches; Fever; Chills; Pain at injection site; This is a spontaneous report from a contactable other healthcare professional. A 35-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, batch/lot: EL1284), intramuscular in the right arm on 28Dec2020 17:45 at a single dose for Covid-19 immunisation. The patient's medical history was none. Patient has no known allergies. Concomitant medication included paracetamol (TYLENOL), ibuprofen and multivitamins. On 29Dec2020, the patient experienced fever, chills, pain at injection site, and body aches. They all started the day after the injection and where mostly gone by the day after that. No treatment was given to the patient for the event. The outcome of the event was recovered in Dec2020. Vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have COVID prior to vaccination. Patient has not been tested positive for COVID post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,TYLENOL; ; MULTIVITAMINS [VITAMINS NOS],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Injection site pain', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,OT 923590,CO,59.0,M,"Feeling tired; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231) via an unspecified route of administration on the right upper arm on 30Dec2020 08:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included lisinopril (LISINOPRIL) for high blood pressure. The patient experienced feeling tired, nauseous and a little headache on 30Dec2020 08:15. Outcome of events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Fatigue', 'Headache', 'Nausea']",UNK,PFIZER\BIONTECH, 923591,NJ,49.0,F,"nausea; chills; malaise; This is a spontaneous report from a contactable nurse reported for herself. A 49-year old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via unspecified route of administration at left arm on 23Dec2020 15:30 at single dose for Covid-19 immunization in a hospital facility. Medical history included Sjogren's syndrome, and chronic sinusitis. The patient was not diagnosed with COVID-19 and did not receive other vaccine in four weeks prior to Covid vaccination. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL), colestyramine (questran), lifitegrast (XIIDRA), and chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX); all from unspecified date for unspecified indication. The patient previously took codeine and Ceftin; both experienced allergies. On 26Dec2020 08:00 three days after receiving vaccine, the patient experienced nausea, chills and malaise. The symptoms lasted for four days (Dec2020). The patient has not been tested for Covid-19 since the vaccination. The patient received no treatment due to the events. The outcome of the events nausea, chills and malaise was recovered. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/26/2020,3.0,PVT,PLAQUENIL; QUESTRAN; XIIDRA; OSTEO BI-FLEX,,Medical History/Concurrent Conditions: Chronic sinusitis; Sjogren's syndrome,,,"['Chills', 'Malaise', 'Nausea']",1,PFIZER\BIONTECH, 923592,,35.0,F,"arm pain, shooting up to neck; arm pain, shooting up to neck; This is a spontaneous report from a non-contactable physician (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at left arm on 23Dec2020 at single dose for Covid-19 immunization in a hospital facility. Medical history included Covid-19 diagnosed prior to vaccination. Concomitant medications included ""OCP"" (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 23Dec2020, the patient experienced arm pain, shooting up to neck. The patient has not been tested for Covid-19 since the vaccination. The patient did not receive treatment for the events. The outcome of the events arm pain, shooting up to neck was recovered. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. No follow-up attempts are possible, information about batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,Medical History/Concurrent Conditions: COVID-19 (diagnosed prior to vaccination),,,"['Neck pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 923593,WA,46.0,F,"rapid heart rate; shortness of breath; This is a spontaneous report from a contactable physician reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date unknown) intramuscular at left arm on 27Dec2020 09:45 at single dose for Covid-19 immunization in a hospital facility. Medical history included hypothyroidism. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included levothyroxine from unspecified date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 27Dec2020 less than 5 minutes after receiving the vaccine, the patient developed rapid heart rate and shortness of breath. The patient has not been tested for Covid-19 post vaccination. The patient did not receive treatment for the events. The outcome of the events rapid heart rate and shortness of breath was recovered in Dec2020. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Hypothyroidism,,,"['Dyspnoea', 'Heart rate', 'Heart rate increased']",UNK,PFIZER\BIONTECH,OT 923594,TN,46.0,F,"Extreme nausea; Dizziness; Extreme fatigue; Different waves of chills to the point of she could not even move; Different waves of chills to the point of she could not even move; sweating; severe headache; just crap now; Now she smells metal; she has no sense of smell other than stinky metallic smell; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the right deltoid on 30Dec2020 08:15 at a single dose for vaccination. The patient's medical history included tested positive for COVID-19 from Jul2020. There were no concomitant medications. Around 30Dec2020 9:00 AM, she began experiencing extreme nausea and dizziness, extreme fatigue, different waves of chills to the point of she could not even move, sweating, severe headache, and just crap now. The patient's physician told that this is something she should report. It could possibly have been an immune response because she had possibly been exposed to COVID-19 that she probably had some sort of antibodies from then until now on Dec2020, even though she tested negative for COVID-19 and continued to test negative for COVID-19 on 2020. She smells metal on Dec2020. She has no sense of smell other than stinky metallic smell. Her taste is fine. Outcome of the headache was not recovered, of the metallic smell was unknown, of the remaining events was recovered on 30Dec2020 13:00.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: COVID-19 virus test positive,,,"['Chills', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Headache', 'Hyperhidrosis', 'Movement disorder', 'Nausea', 'Parosmia', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 923595,NJ,40.0,F,"left arm hurting; nauseous; UTI; whole body is hot; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unknown), via an unspecified route of administration on the left arm, on 19Dec2020 at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she took the vaccine on 19Dec2020. On an unspecified date, patient stated that she had no side effects only her arm was hurting. She stated that her whole body is hot. Stated that she has no temperature and is a little nauseous. Stated that whererever she lays down at one can feel the heat. She stated that it was Pfizer BioNTech Covid 19 vaccine EUA is concerned. She stated that she went to the ER and they thought it was because she was taking a medication for urinary tract infection (UTI) and that she was having a reaction. She stated that her doctor told her that the second day she would have had side effects to UTI medicine. She stated that the doctor is stating that it is due to the vaccine. She wanted to know if she should go back to the ER. She stated that her doctor told her to call the place where the vaccine was received for them to monitor her. She stated that she went through her job off site and that this was her first shot. She clarified that she received the shot in her left arm and it was hurting. Outcome of the events was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,,,UNK,,,,,,"['Feeling hot', 'Nausea', 'Pain in extremity', 'Urinary tract infection']",1,PFIZER\BIONTECH, 923596,OK,63.0,F,"low grade fever/fever; 100 degrees Fahrenheit/99.2 degrees Fahrenheit/99.8 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) at the public health department via unspecified route of administration at right arm on 28Dec2020 12:30 as single dose to prevent getting the Covid virus. Medical history included medication allergies (allergic to like 3 to 4 medications), allergic to sulfur/sulfa, allergic to penicillin, allergic to ""-mycins"", allergic to dye (for a CT scan). The patient informed that she was given the Pfizer shot, clarified to Pfizer-BioNTech COVID-19 vaccine on Monday (verified to be the 28th). The patient informed that since then she has had a low grade fever and the patient would like to talk to someone to see if that was normal, since it was still not gone. The patient got her first dose of the vaccine injected into her right arm around 12:30 PM Monday (28Dec2020), and her fever started Monday night and got to 100 degrees Fahrenheit and since then she has been running 99.2 degrees Fahrenheit (Dec2020), it was 99.8 degrees Fahrenheit now (30Dec2020). The patient stated ""it didn't say on the vaccine card, but the sheet they gave with it says it is the Pfizer-BioNTech COVID-19 vaccine. All that is on there is the date she got it, 18Nov2020 and the healthcare girl put her initials on it"" (unable to clarify discrepancy between the dates provided as caller continued speaking). The patient informed that she was supposed to have turned around on the 18th to get the second shot (unable to clarify statement and the caller may have meant that she was supposed to get the second dose of the shot on 18Jan2021, and misread the card as she seemed to have difficulty reading the nurse's handwriting on it). The reporter informed that the LOT number was written with an E and then either a V or a K, it looks like a V but the girl put a leg on there so maybe it was a K then 9231, or EV or 9231 or 9731. The outcome of the event ""pyrexia"" was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PUB,,,Medical History/Concurrent Conditions: Allergy to antibiotic; Contrast media allergy (for a CT scan); Drug allergy (allergic to like 3 to 4 medications); Penicillin allergy; Sulfonamide allergy,,,"['Body temperature', 'Pyrexia']",1,PFIZER\BIONTECH, 923597,MO,41.0,F,"hives; intense itching; headache; injection site is red and raised and itches intensely.; injection site is red and raised and itches intensely.; injection site is red and raised and itches intensely.; This is a spontaneous report from a contactable nurse. A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in the right arm, on 28Dec2020 at 08:45 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccine wad administered at a hospital. There were no other vaccinations given within 4 weeks and no other medications were taken within 2 weeks. Medical history included allergies to penicillin and shrimp. There were no concomitant medications. The patient previously took codeine and experienced an allergy. On 28Dec2020, the patient experienced hives, intense itching coupled with a headache, injection site is red, raised and itched intensely. The clinical course was as follows: Within 3 hours of receiving the vaccine she developed hives and intense itching coupled with a headache. She reported that the hives come and go and have covered pretty much her entire body in waves of occurrences. The injection site was red and raised and itched intensely. It has been 48 hours since and still there are hives. The patient was not hospitalized for the events. Treatment included diphenhydramine (BENADRYL) however she stated that it does not seem to affect the hives or address the itching. The clinical outcome of the events: hives, intense itching coupled with a headache, injection site is red, raised and itched intensely, was not recovered. The patient was not tested for COVID-19 after receiving the vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,,"Medical History/Concurrent Conditions: Food allergy; Penicillin allergy (known allergies PCN, CODINE, SHRIMP)",,,"['Headache', 'Pruritus', 'Urticaria', 'Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site swelling']",UNK,PFIZER\BIONTECH,OT 923598,TN,48.0,F,"she received the COVID Vaccine on the evening of Christmas, and then she tested positive for COVID on Sunday; she received the COVID Vaccine on the evening of Christmas, and then she tested positive for COVID on Sunday; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); in the left arm on 25Dec2020 as a single dose, for COVID-19 immunization. The patient had no known medical history. There were no concomitant medications. Caller confirmed the product was not specifically prescribed to her, but she received it via an options at her company and had received no other vaccines on the same day as the COVID vaccine. The patient received the COVID Vaccine on the evening of Christmas 25Dec2020, and then she tested positive for COVID on Sunday, 27Dec2020. The patient had a positive SARS-CoV-2 test on 27Dec2020. The clinical outcome of the event Drug ineffective and COVID-19 was unknown. Information regarding lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/25/2020,12/27/2020,2.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 923599,MI,44.0,F,"Nausea; Headache; Fatigue started about 5 hours after injection and seems to be getting worse; Muscle aches-started about 5 hours after injection and seems to be getting worse; Stiff Arm; Slight pain at injection site; This is a spontaneous report from a contactable nurse, the patient. A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685), via an unspecified route of administration, in the right arm on 30Dec2020 at 06:45 AM (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included crohn's disease, ankylosing spondylitis, gastroparesis, and sulfa allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Dec2020 at 07:45 AM, about an hour after injection, the patient experience nausea and headache. Fatigue and muscle aches started about 5 hours after injection and seemed to be getting worse. The patient experienced stiff arm 12 hours after injection, and slight pain at injection site after 12 hours. The events were reported as non-serious. The patient did not receive any treatment for the nausea, headache, fatigue, muscle aches, stiff arm, and slight pain at injection site. The clinical outcome of the events nausea, headache, fatigue, muscle aches, stiff arm, and slight pain at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Ankylosing spondylitis; Crohn's disease; Gastroparesis; Sulfonamide allergy (known allergies: Sulfa),,,"['Fatigue', 'Headache', 'Musculoskeletal stiffness', 'Myalgia', 'Nausea', 'Vaccination site pain']",1,PFIZER\BIONTECH, 923600,IN,,U,"as a person with severe cough variant asthma, he/she immediately noticed a change in his/her breathing/ breathing so much better; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing severe cough variant asthma. The patient's concomitant medications were not reported. The patient reported he/she just received the covid vaccine the day before reporting date and wanted to let company know that as a person with severe cough variant asthma, he/she immediately noticed a change in his/her breathing. It was very noticeable all of the day 28Dec2020 and even this morning (29Dec2020). He/she was breathing so much better. The outcome of the event was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,UNK,,Cough variant asthma,,,,['Therapeutic response unexpected'],UNK,PFIZER\BIONTECH, 923601,PA,44.0,F,"developed chest pain with radiation into axilla, shoulder, scapula and down the arm; axilla discomfort; arm discomfort; Pain felt similar to sciatica; a full nagging pain and the muscles of my arm are fatigued from constant tension; a full nagging pain and the muscles of my arm are fatigued from constant tension; This is a spontaneous report from a contactable Nurse reported for herself. This 44-year-old female Nurse (patient) receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1685), via an unspecified route of administration on 22Dec2020 09:30 at single dose on left arm for Covid-19 immunisation. There was no known allergies, medical history nor concomitant medications. Prior to vaccination, it was not unknown if the patient diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 4 days following the vaccination on 26Dec2020 18:00, the patient developed chest pain with radiation into axilla, shoulder, scapula and down the arm. The chest pain and axilla discomfort subsided but the arm discomfort continued and intensified. Pain felt similar to sciatica. The patient took ibuprofen and paracetamol (TYLENOL) also placed ice pack under her arm and on top of shoulder. The following day the patient started on a methylprednisolone (MEDROL) dose pack. The patient received minor relief with the steroids and NSAIDs after 2 days she took a gabapentin (NEURONTIN) which was given to me by a family member. The gabapentin had given the most benefit. On day 4, the patient continue to have a full nagging pain and the muscles of her arm are fatigued from constant tension. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/26/2020,4.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Axillary pain', 'Chest pain', 'Fatigue', 'Limb discomfort', 'Muscle tightness', 'Pain']",UNK,PFIZER\BIONTECH, 923602,PA,36.0,F,"Fever 100.0; severe headache; malaise; fatigue; This is a spontaneous report from a contactable pharmacist (the patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK5730), intramuscularly in the left arm on 22Dec2020 at 09:30 (at the age of 36-years-old) as a single dose for COVID-19 immunization. Medical history included multiple sclerosis. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: ergocalciferol (VITAMIN D), natalizumab, and topiramate, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 23Dec2020 at 09:00, the patient experienced fever 100.0, severe headache, malaise, and fatigue post injection. No treatment was given for these events. The clinical outcome of fever 100.0, severe headache, malaise, and fatigue post injection was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,PVT,VITAMIN D [ERGOCALCIFEROL]; ;,,Medical History/Concurrent Conditions: Multiple sclerosis,,,"['Body temperature', 'Fatigue', 'Headache', 'Malaise', 'Pyrexia']",1,PFIZER\BIONTECH, 923603,NY,37.0,F,"Index and middle fingers in both hands broke out in what appears to be very similar rash to my nickel allergy; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK5730) solution for injection in the left arm on 28Dec2020 at 14:15 (at the age of 37-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included allergies to medications, food, or other products: nickel. Concomitant medications included ascorbic acid/biotin/tocopheryl acetate (BIOTIN GUMMY); ergocalciferol (VITAMIN D); and WOMEN'S ONE A DAY MULTIVITAMIN. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 30Dec2020, the patient experienced index and middle fingers in both hands broke out in what appears to be very similar rash to my nickel allergy despite the fact that I have not worn any jewelry or did anything out of the norm. Treatment was provided for the event rash included applying hydrocortisone and diphenhydramine (BENADRYL). The outcome of the event rash was not recovered. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,BIOTIN GUMMY; VIT D,,"Medical History/Concurrent Conditions: Nickel sensitivity (Allergies to medications, food, or other products: Nickel)",,,['Rash'],1,PFIZER\BIONTECH, 923604,MI,32.0,F,"Fever (102 F); Chills; Tired; Muscle aches; Some upset stomach the night of the vaccination (12 hours after administration); Headache; This is spontaneous report from a contactable other-HCP (patient). A 32-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot: unknown) intramuscularly on 30Dec2020 12:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took amoxicillin (reported as ammoxicillin) and experienced drug allergy. The patient experienced fever (102 F) and chills on 31Dec2020 12:00, muscle aches and some upset stomach the night of the vaccination and headache (12 hours after administration), tired the day after (31Dec2020 12:00). No treatment received for the adverse events. This is a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 31Dec2020. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Abdominal discomfort', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,OT 923605,MO,51.0,F,"Eyes started swelling, around my eye the left one, it is more around the eyes it's worse; Eyes started swelling, around my eye the left one, it is more around the eyes it's worse; Swelling around mouth; Aching in my mid back; I have been extremely tired too. I was sitting at my desk at work yesterday and I was nodding of; I have been extremely tired too. I was sitting at my desk at work yesterday and I was nodding of; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Batch/Lot number: EL1284), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medications included montelukast, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY); colecalciferol (vitamin D), and bumetanide (BUMEX). The nurse stated that she got the Pfizer COVID Vaccine yesterday (28Dec2020) and she didn't know if she should report the side effects but she didn't yesterday and she was going to today (29Dec2020). It didn't happen right away, it was like throughout the day, her eyes started swelling around them, she had swelling around her mouth, she still has it actually. She didn't have any breathing issues but there was a lot of aching in her mid back which was gone now, the aching part, but it was the swelling that concerned her. They were around her eye, the left one. She had a question herself though because this was just her first vaccine. She meant it wasn't bad enough that she had breathing issues because she monitored it and it's already in there now. She asks if it would it be okay to get the next one. As treatment, the patient took Tylenol and a Benadryl. The patient also mentioned that she has been extremely tired too. What she meant was she was sitting at her desk at work yesterday and she was nodding off. According to her, it was just offered through work and they went to a hospital to get it. The patient said that she did not have to seek medical treatment for it, so it was not like life threatening. When clarified if the swelling around eyes was still there, the patient stated that it was not as prominent, it was more around the eyes it's worse. She further stated that it has improved, she was still tired but the swelling had improved. The patient was also asked regarding the route of administration and she stated that she believes it was long enough to be, it looked like IM, she was not sure. It might have been a SubQ but she means it wasn't like a huge long needle but it wasn't like the real short ones either. Outcome of the events ""Eyes started swelling, around my eye the left one, it is more around the eyes it's worse"", ""Swelling around mouth"", ""Aching in my mid back"", was recovering/resolving; for the event 'Fatigue' was not recovered, while for 'Somnolence' was unknown. Causality assessment of the reporter between the events 'eye swelling', 'swelling around mouth', 'aching in my mid back', and 'I have been extremely tired too. I was sitting at my desk at work yesterday and I was nodding of' and BNT162B2 was reported as related.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,; TRELEGY; VITAMIN D [COLECALCIFEROL]; BUMEX,,,,,"['Back pain', 'Circumoral swelling', 'Eye swelling', 'Fatigue', 'Periorbital swelling', 'Somnolence']",1,PFIZER\BIONTECH, 923606,GA,29.0,F,"Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; This is a spontaneous report from a contactable health care professional nurse, the patient. A 29-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 29DEC2020 09:15 as a single dose for COVID-19 immunization. Medical history included depression from an unknown date and unknown if ongoing, and Covid-19 on '17th of this month ' and unknown if ongoing. The patient had no known allergies. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), spironolactone (SPIRONOLACTONE), desogestrel, ethinylestradiol (KARIVA). No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. On 29Dec2020 16:30, the patient experienced Arm pain that gradually turned into body pain, joint pain, chills. The pain was so extreme. Patient had Covid on the 17th of this month and was not told that you should wait 90 days after to get the vaccine. The patient reported her response was worse than the side effects of Covid. The events result in a Physician Office Visit The patient was treated for Arm pain that gradually turned into body pain, joint pain, chills with Heating pads, Ibuprofen (Manufacturer Unknown) and Tylenol alternated. The clinical outcome of arm pain that gradually turned into body pain, joint pain, chills was recovered. Information regarding lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,UNK,EFFEXOR; ; KARIVA,,"Medical History/Concurrent Conditions: COVID-19 (If covid prior vaccination: Yes, Had Covid on '17th of this month '); Depression",,,"['Arthralgia', 'Chills', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 923607,PA,40.0,M,"heart palpitations; Hypoglycemia; Abnormal EKG; I had a near sick able episode and I had a rapid heart rate; I had a near sick able episode and I had a rapid heart rate; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Batch/lot number: EK5730, via an unspecified route of administration on 26Dec2020 as a single dose (age at vaccination: 40 years old), right arm for COVID -19 immunization. Medical history included chronic back pain. Concomitant medication included amitriptyline (AMITRIPTYLINE), cyclobenzaprine (FLEXERIL) for chronic back pain, and hydrocodone bitartrate, paracetamol (NORCO) for chronic back pain. On 26Dec2020, the patient had a ""near sick able episode"" and a rapid heart rate. The initial side effect was about 7 minutes after the patient had the vaccine, came on just very quickly. The place where they had the patient discharged him, allowed him to go home, but the rapid heart rate stayed with the patient for next 24 hours and he went to an urgent care and they sent him to emergency room. The patient went to the emergency room (27Dec2020) and they ran an EKG, X-ray, and did a COVID swab; everything came back negative. Lab work, X-ray everything came back fine, the only thing they found was hypoglycemia, heart palpitations, and abnormal EKG, which was described by the reporter as ""normal sinus rhythm left axis deviation pulmonary disease pattern"" and then at the bottom it said ""abnormal EKG."" Heart rate was 136/88 (as reported) so it was definitely improving, the highest it was at 189/110 (as reported). No treatment was received for the events. The clinical outcome of the events ""near sick able episode,"" rapid heart rate, and palpitations was recovering, while the clinical outcome of hypoglycemia and abnormal ECG was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/26/2020,0.0,UNK,; FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]; NORCO,,Medical History/Concurrent Conditions: Chronic back pain,,,"['Blood glucose', 'Electrocardiogram', 'Electrocardiogram abnormal', 'Heart rate', 'Heart rate increased', 'Hypoglycaemia', 'Laboratory test', 'Palpitations', 'Presyncope', 'SARS-CoV-2 test', 'X-ray']",UNK,PFIZER\BIONTECH, 923608,,1.17,U,"currently nursing my baby who is 14 months old.; This is a spontaneous report from a contactable nurse practitioner. This nurse practitioner reported information for both mother (Self) and her 14-month-old patient infant. A 14-months-old of an unspecified gender started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), (age at vaccination 14-month-old) transmammary on an unspecified date in Dec2020. The infant's mother received the vaccine for COVID-19 immunisation. The infant's mother reported she was a nurse practitioner working at a local urgent care center. She was currently nursing her baby who is 14 months old. Due to the high risk of getting COVID19, the mother decided to get COVID 19 vaccination despite lack of data on lactating women. She received my Pfizer COVID 19 vaccination 3 days ago (Dec2020). Outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021001535 mother case",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,['Exposure via breast milk'],UNK,PFIZER\BIONTECH,OT 923609,,,U,"tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). The consumer reported for self and husband. This is the first of two reports, and concerns the reporter (patient). A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EJ1685/expiration date: 31Mar2021), via an unspecified route of administration, on 19Dec2020, as a single dose for COVID-19 immunization. Relevant medical history and concomitant medication were not provided. On an unspecified date in Dec2020, the patient tested positive for COVID. The outcome of the event tested positive for COVID was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/01/2020,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 923610,,,M,"tested positive for COVID; tested positive for COVID; Flu; This is a spontaneous report from a contactable consumer. The consumer reported for self and husband. This is the second of two reports and concerns the reporter's husband. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EH9899/expiration date: not provided), via an unspecified route of administration, on 18Dec2020, as a single dose for COVID-19 immunization. Relevant medical history and concomitant medication were not provided. On an unspecified date in Dec2020, the patient experienced the flu after receiving the vaccine. On an unspecified date in Dec2020, the flu symptoms went away and the patient tested positive for COVID. The outcome of the event flu was recovered in Dec2020 and the outcome of tested positive for COVID was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/01/2020,,UNK,,,,,,"['Influenza', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 923611,TX,62.0,F,"Swelling, and warmth at injection site, right arm; Swelling, and warmth at injection site, right arm; swollen and tender right axillary node under right arm; swollen and tender right axillary node under right arm; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140), intramuscular on 22Dec2020 10:30 at first single dose at arm right for covid-19 immunisation . Medical history included breast cancer, allergy to penicillin, levaquin, neosporin, cocoa butter. Concomitant medication included vitamin c [ascorbic acid]. The patient experienced swelling, and warmth at injection site, right arm, swollen and tender right axillary node under right arm on 28Dec2020 16:00. No treatment for events. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/28/2020,6.0,PVT,VITAMIN C [ASCORBIC ACID],,Medical History/Concurrent Conditions: Allergy; Breast cancer female; Penicillin allergy,,,"['Lymph node pain', 'Lymphadenopathy', 'Vaccination site swelling', 'Vaccination site warmth']",1,PFIZER\BIONTECH,OT 923612,TX,42.0,F,"vaccination site pain; Tiredness; Headache; Joint pain; Muscle pain; Night sweats; This is a spontaneous report from a contactable Pharmacist, the patient. This 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730), intramuscularly in the right arm on 30Dec2020 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included Graves' disease from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing and anxiety from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE), duloxetine (DULOXETINE). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. On 31Dec2020 at 02:00, the patient experienced vaccination site pain, tiredness, headache, joint pain, muscle pain and night sweats. No therapeutic measures were taken as a result of the events. The clinical outcome of the vaccination site pain, tiredness, headache, joint pain, muscle pain and night sweats was resolving. It was also reported that since the vaccination, the patient had been tested on 31Dec2020 for COVID-19 with results pending.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,;,,Medical History/Concurrent Conditions: Anxiety; Graves' disease; Irritable bowel syndrome,,,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Night sweats', 'SARS-CoV-2 antibody test', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 923613,FL,37.0,F,"developed a fever as high as 101.8; chills; This is a spontaneous report from a contactable pharmacist (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: EK9231), via intramuscular route of administration, on 23Dec2020 at 02:00 PM (at the age of 37 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Dec2020, at 03:00 PM, the patient developed a fever as high as 101.8 (no units provided) with no other symptoms beyond fever and chills. The patient did not take any anti-pyretics to treat the fever and her temperature came down on its own overnight. By the next day, she felt back to normal. No treatment was received for the events fever and chills. The outcome of the events fever and chills was recovered on 30Dec2020. Since the vaccination, the patient had been tested for COVID-19 (via saliva polymerase chain reaction [PCR]) with negative result.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/29/2020,6.0,PVT,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: no diagnosed health conditions",,,"['Body temperature', 'Chills', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 923614,,26.0,F,"Shortness of breath; chest pain; body aches; joint pain; headache; nausea; congestion; This is a spontaneous report received from a non-contactable nurse (who is also the patient). A 26-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El0140), intramuscular in right arm, on 29Dec2020 17:30, at single dose, for COVID-19 immunization. Medical history included spontaneous pneumothorax x2 on the right with VATS surgery on an unspecified date and multiple food allergies. The patient is not pregnant. Concomitant medication included montelukast sodium (SINGULAIR) and loratadine (CLARITIN). The patient experienced shortness of breath, chest pain, body aches, joint pain, headache, nausea and congestion, all on 30Dec2020 at 05:00. The patient did not receive treatment for the events. The patent did not receive any other vaccines within 4 weeks prior to BNT162B2. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The reporter assessed the case as non-serious. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,UNK,SINGULAIR; CLARITIN [LORATADINE],,Medical History/Concurrent Conditions: Food allergy (Multiple food allergies); Pneumothorax spontaneous (Spontaneous pneumothorax x2 on the right with VATS surgery); Video-assisted thoracoscopic surgery (Spontaneous pneumothorax x2 on the right with VATS surgery),,,"['Arthralgia', 'Chest pain', 'Dyspnoea', 'Headache', 'Nasal congestion', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,OT 923615,NY,43.0,M,"Pain at injection site; headache; muscle pain; chills; joint pain; tiredness; fever; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via intramuscular route of administration, on 28Dec2020 at 09:15 AM (at the age of 43 years old) as a single dose in the right arm for COVID-19 immunization. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Concomitant medication were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, at 11:30 PM, the patient experienced pain at injection site, headache, muscle pain, chills, joint pain, fever, tiredness and nausea. No treatment was received for the events pain at injection site, headache, muscle pain, chills, joint pain, fever, tiredness and nausea. The outcome of the events pain at injection site, headache, muscle pain, chills, joint pain, fever, tiredness and nausea was recovered on an unspecified date in Dec2020. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 923616,NJ,34.0,M,"Burning anterior thigh pain on left 13hrs after injection; Burning hand pain on right; right hand was warm to touch relative to left; This is a spontaneous report from a contactable healthcare professional reporting for himself. A 34-year-old male received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK9231/expiration date: not provided), via an unspecified route of administration, on 28Dec2020 at 08:00 PM (at the age of 34 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history included hypertension (HTN), polymyositis, and psoriasis. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included olmesartan medoxomil (BENICAR), methotrexate, prednisone, vitamin C, and vitamin D. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 at 08:40 PM, 40 minutes after injection, the patient experienced burning hand pain on right, and the right hand was warm to touch relative to left. On 29Dec2020 at 09:00 AM, 13hrs after injection, the patient experienced burning anterior thigh pain on left. Treatment for the events included physical therapy nerve glides: for burning hand pain on right, and the right hand was warm to touch relative to left included Median Nerve Glides, with a frequency of once a day which improved 99% in 24hrs; and treatment for the event burning anterior thigh pain on left included Femoral Nerve Glides, with a frequency of 2-5 times a day which improved 85% in 3 days. The patient was recovering from the events burning hand pain on right, the right hand was warm to touch relative to left, and burning anterior thigh pain on left. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,BENICAR; ; ; VIT C; VIT D,,Medical History/Concurrent Conditions: Hypertension; Polymyositis; Psoriasis,,,"['Feeling hot', 'Pain in extremity']",1,PFIZER\BIONTECH, 923617,MN,29.0,F,"Fatigue; Nausea; Headache; Abdominal pain; Muscle soreness (spot of injection, it is better now); This is a spontaneous report from a contactable other healthcare professional, the patient. A 29-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0140), via an unspecified route of administration on 28Dec2020 at 04:00 PM (at the age of 29-years-old) as a single dose in the left arm for COVID-19 vaccination. The patient had no relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient's concomitant medications in the past two weeks included bupropion hydrochloride ER 200 mg and ritual vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020, the patient experienced fatigue, nausea, headache, abdominal pain and muscle soreness (spot of injection is better now). The patient did not receive any treatment for the events. The clinical outcome of fatigue, nausea, headache, abdominal pain and muscle soreness was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,WRK,BUPROPION HCL ER,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Abdominal pain', 'Fatigue', 'Headache', 'Myalgia', 'Nausea']",1,PFIZER\BIONTECH, 923618,,,F,"Caller received COVID vaccine on the 18th then tested positive on the 24th; Caller received COVID vaccine on the 18th then tested positive on the 24th; This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that the patient received COVID 'vaccine on the 18th then tested positive on the 24th'. The reporter mentioned that a friend who works for Pfizer told her to call and report. Clinical outcome of the events was unknown. Information on batch/lot number was requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the short duration of 6 days since the vaccine first dose is given.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/24/2020,6.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 923619,LA,34.0,F,"Rash; hives; This is a spontaneous report from a contactable other healthcare professional. This other healthcare professional reported that a 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown), via an unspecified route on 30Dec2020 (at the age of 34 years-old) as a single dose (dose 1) for COVID-19 vaccination. Medical history included metabolic syndrome, tachycardia, interstitial cystitis, anxiety, depression, gastroesophageal reflux (GERD), migraines, polycystic ovarian syndrome (PCOS) and allergy to chocolate, vitamin E and cefaclor (CECLOR). The patient was not pregnant at the time of vaccination. Prior to the vaccination the patient was not diagnosed with COVID-19. Concomitant medications included dulaglutide (TRULICITY), metformin, dexlansoprazole (DEXILANT), lamotrigine (LAMICTAL), nitrofurantoin (MACRODANTIN), prazosin, vilazodone hydrochloride (VIBRYD), cefixime (FLEXERIL), ergocalciferol (DRISDOL), topiramate (TOPAMAX) and sumatriptan succinate (IMITREX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Dec2020 at 09:30 PM, the patient experienced rash and hives. The report was reported as non-serious. The adverse events rash and hives resulted in physician office visit, emergency room/department or urgent care. The patient was treated for the rash and hives with diphenhydramine (BENADRYL) and prednisone. The clinical outcome of rash and hives was unknown. Since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,TRULICITY; ; DEXILANT; LAMICTAL; MACRODANTIN; ; VIIBRYD; FLEXERIL [CEFIXIME]; DRISDOL; TOPAMAX; IMITREX,,Medical History/Concurrent Conditions: Anxiety; Cystitis interstitial; Depression; Food allergy (chocolate); GERD; Metabolic syndrome; Migraine; Polycystic ovarian syndrome; Tachycardia,,,"['Rash', 'Urticaria']",UNK,PFIZER\BIONTECH, 923620,MI,58.0,F,"Swelling of my arm and hand; Swelling of my arm and hand; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EL0140), via an unspecified route of administration, on 30Dec2020 at 04:30 PM (at the age of 58-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the right arm. Medical history included Allergy induced asthma. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included montelukast sodium (SINGULAIR) (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN), estradiol (ESTROGEN) (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Sulfa (MANUFACTURER UNKNOWN) and Keflex (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced allergy. On 31Dec2020, the patient reported ""Swelling of my arm and hand."" The patient did not receive any treatment for the events. The clinical outcome of the events swelling of my arm and hand was recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,SINGULAIR; ; ESTROGEN,,Medical History/Concurrent Conditions: Asthma (Allergy induced asthma); Sulfonamide allergy,,,['Peripheral swelling'],1,PFIZER\BIONTECH, 923621,LA,64.0,M,"Headache; I got small fever like 99.9; Muscle pain; Feeling unwell; Difficult breathing just a little bit just like a cough a little small cough; Difficult breathing just a little bit just like a cough a little small cough; Dizziness; Cold; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. Medical history included diabetes, high blood pressure, and cholesterol. Concomitant medications included diabetes medication, medications for high blood pressure and for cholesterol. The patient stated that he got the Pfizer vaccine on Christmas eve that would be the 24th and today (30Dec2020) he was getting just small things like headache, fever (small fever like 99.9), muscle pain, feeling unwell, difficult breathing just a little bit just like a cough a little small cough, dizziness, and probably just a cold. There was no injection swelling, fast heartbeat, and rash. He doesn't know if he should go get tested for COVID or not because he just took the shot. The patient stated that he got to get the next dose of the vaccine on the 14th of January. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/30/2020,6.0,UNK,,,Medical History/Concurrent Conditions: Blood cholesterol abnormal; Blood pressure high; Diabetes,,,"['Body temperature', 'Cough', 'Dizziness', 'Dyspnoea', 'Headache', 'Malaise', 'Myalgia', 'Nasopharyngitis', 'Pyrexia']",1,PFIZER\BIONTECH, 923622,MN,23.0,F,"Severe headache, fatigue, nausea; Severe headache, fatigue, nausea; Severe headache, fatigue, nausea; This is a spontaneous report from a non-contactable nurse, reporting for the patient. A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EJ1685), via intramuscular route of administration, on 30Dec2020 at 12:45 AM (at the age of 23-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. Medical history not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Penicillin (MANUFACTURER UNKNOWN) and Codeine (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced allergy. On 30Dec2020 at 07:00PM, the patient experienced severe headache, fatigue, and nausea. The patient did not receive any treatment for the events. The clinical outcome of the events severe headache, fatigue, and nausea was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Fatigue', 'Headache', 'Nausea']",1,PFIZER\BIONTECH,OT 923623,NC,30.0,F,"Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; This is a spontaneous report from a contactable Nurse (the patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL0140, expiration date unknown) via an unspecified route of administration on 29Dec2020 at 12:30 PM (at the age of 30-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. The patient's medical history was not reported. No information was reported regarding allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient answered ""yes"" when asked to list any other medications she had received within two weeks of vaccination but did not list those medications. The patient stated that she experienced lightheadedness on 29Dec2020 ""immediately after vaccine."" About twenty-four hours later, on 30Dec2020 at 13:00 she experienced ""SEVERE"" diarrhea/urgency, nausea, fatigue, fever of 101 and migraine. The patient did not receive any treatment for the events. The clinical outcomes of lightheadedness, severe diarrhea/urgency, nausea, fatigue, fever of 101 and migraine were reported as recovering. The patient underwent lab tests and procedures which included body temperature: 101 on 30Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Body temperature', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Migraine', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH, 923624,NJ,,M,"runny nose after getting the vaccine; This is a spontaneous report from a contactable consumer. An adult male patient, of an unspecified age, received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the vaccination. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19. On an unspecified date, the patient had a runny nose after getting the vaccine. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The clinical outcome of the runny nose after getting the vaccine was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Rhinorrhoea'],UNK,PFIZER\BIONTECH, 923625,,35.0,F,"Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; This is a spontaneous report from a Non-contactable Physician (patient). A 35-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , via an unspecified route of administration on 23Dec2020 at first single dose at arm left for covid-19 immunisation. The patient received the vaccine at hospital. Medical history included migraine, dermatitis atopic. The patient's concomitant medications were not reported. The patient experienced Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache on 24Dec2020. No treatment for events. The outcome of events was recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Atopic dermatitis; Migraine,,,"['Arthralgia', 'Body temperature', 'Headache', 'Myalgia', 'Nausea', 'Paraesthesia', 'Pyrexia', 'Rash']",1,PFIZER\BIONTECH, 923626,GA,31.0,F,"Arm soreness; headache; shakiness; nausea; diarrhea; This is a spontaneous report from a contactable other health professional reported for herself. A 31-year-old female patient (not pregnant at time of the report) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), intramuscularly on left arm on 30Dec2020 14:30 at single dose for COVID-19 immunization. Facility type Vaccine was reported as Doctor's office/urgent care. Medical history included SVT, neurocardiogenicy syncope, PVCS, known allergies: PCN. Concomitant medications were not reported. The patient experienced arm soreness, headache, shakiness, nausea, diarrhea on 31Dec2020. No treatment was received for the events. The outcome of the events were not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Neurocardiogenic syncope (neurocardiogenicy syncope); Penicillin allergy; Premature ventricular contractions; Supraventricular tachycardia,,,"['Diarrhoea', 'Headache', 'Nausea', 'Pain in extremity', 'Tremor']",1,PFIZER\BIONTECH,OT 923627,CA,42.0,F,"Hives and rash under armpits, up neck, and in groin area; Hives and rash under armpits, up neck, and in groin area; This is a spontaneous report from a contactable nurse (patient herself). A 42-Year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140 and expiration date unknown), via an unspecified route of administration at Left arm on 21Dec2020 07:15 AM at single dose for covid-19 immunisation; levothyroxine sodium (SYNTHROID), via an unspecified route of administration from an unknown date at 125ug daily for hypothyroidism. The patient medical history include hypothyroidism. The patient has no known allergies. The patient experienced hives and rash under armpits, up neck, and in groin area on 23Dec2020 with outcome recovered. Events were considered as non-serious with no treatment. The patient has not tested for COVID-19 before or after the vaccination. The action taken in response to the event for levothyroxine sodium was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/23/2020,2.0,PVT,SYNTHROID,,Medical History/Concurrent Conditions: Hypothyroidism,,,"['Rash', 'Urticaria']",1,PFIZER\BIONTECH,OT 923628,,,M,"night sweats; fatigues; muscle aches; chills; sore arm; mild aches; fever; This is a spontaneous report from a contactable nurse (patient). A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient is a NP who received his first dose of the Covid19 vaccine last week. He reported a sore arm and mild aches that resolved after 48 hours; then he developed night sweats, fatigues, muscle aches, and 3 days of a fever. He reported the fever has 'broken', but that chills continued along with fatigue. No one else in his household had these symptoms, so he didn't believe them to be infectious. Didn't seem to have any infectious disease symptoms. The outcome of the events sore arm, mild aches, fever was recovered, of the events fatigue and chills was not recovered, of the other events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,,,UNK,,,,,,"['Chills', 'Fatigue', 'Myalgia', 'Night sweats', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH, 923629,MI,41.0,F,"got a very metallic taste in my mouth; sleep a lot; tired; This is a spontaneous report from a contactable healthcare professional. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140/ELO140), via an unspecified route of administration, at the left arm on 30Dec2020 06:30 at a single dose for COVID-19 immunization at a hospital. Medical history included seasonal allergies and doesn't take medications. On the same day of 30Dec2020, about an hour after vaccination, patient got a very metallic taste in mouth, which lasted for about 12-18 hours and did sleep a lot, which she expected, but woke up about 11 at night and still had it and it was gone. Patient knew she slept longer than she normally does, went to bed at 1PM and slept until 11PM, which is not usually normal. Was up for about an hour or two and then went back to bed until 8AM of 31Dec2020. Patient was concern was if it was some type of reaction that it would mean she was going to have a stronger reaction to the second one and stated it was irritating but not a huge deal. Patient also felt tired and expected it as she worked five 12-hour shifts in a row. Patient was not sure if the metallic taste was connected to the COVID-19 vaccine. No prior vaccinations within 4 weeks. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Seasonal allergy,,,"['Dysgeusia', 'Fatigue', 'Hypersomnia']",1,PFIZER\BIONTECH, 923630,TX,38.0,F,"itching; This is a spontaneous report from a contactable nurse reported for herself. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiration date unknown), via an unspecified route of administration on the right upper arm deltoid on 28Dec2020 at single dose for covid-19 immunisation. The patient medical history included Gallbladder removal from 2019 to 2019, asthma but grew out of it which the last time she had an attack was when she was 12 years old, C-sections for her kids. The patient concomitant medications reported as none. The patient was got the COVID vaccine, the first shot and she experienced itching that's why she took the Benadryl 50 mg. She didn't know if that was normal for people who had the covid vaccine to experience this. The vaccine was received on Monday, 28Dec2020 and the itching started Tuesday on 29Dec2020. She was ok on Wednesday 30Dec2020 but today she is itching again. She took Benadryl 50mg the day the itching started, just once and the next day she was fine. It is explained that the itching was not severe and she was not scratching her skin, she just feel itchy like something was crawling on her skin. She has no known allergies but does remember when C sections had for her kids, she had severe itching with the epidural, she experienced this with but it happens every time she gets an epidural. She has had no adverse events or allergic reactions to any other vaccines. The vaccine was administered on the right upper arm deltoid. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,UNK,,,"Medical History/Concurrent Conditions: Asthma (but grew out of it, the last time she had an attack was when she was 12 years old); Cesarean section; Gallbladder removal",,,['Pruritus'],1,PFIZER\BIONTECH, 923631,ID,53.0,F,"Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; This is a spontaneous report from a contactable Nurse (Patient). A 53-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ej1685) , via an unspecified route of administration on 22Dec2020 11:00 at first single dose at arm left for covid-19 immunisation . Medical history included iodine allergy. Concomitant medication included fish oil. The patient experienced Chills, muscle/joint pain, headache, injection site pain, fever 103.9 on 22Dec2020 21:00. Therapeutic measures were taken as a result of events was Ibuprofen. The outcome of events was recovered with sequelae. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,OTH,,,Medical History/Concurrent Conditions: Iodine allergy,,,"['Arthralgia', 'Body temperature', 'Chills', 'Headache', 'Injection site pain', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH, 923633,,,M,"severe hip pain and low back; severe hip pain and low back; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 24Dec2020 15:30 to at a single dose, for COVID-19 immunization. Medical history included arthritis in the lumbar region, a slight herniated disc. The patient's concomitant medications were not reported. Two (2) days after vaccination, in the morning of 26Dec2020, he had 'severe hip pain and low back'. It was stated that he did not do anything to flare that up. Also, never had pain in his hips before, and the pain in his back is higher. He has been off work this week due to the pain. Visited ER doctor who provided recommendations including application of heat. It is not getting better. Although with heat it feels better. The outcome of events was recovering. Follow-up attempts are completed. The following information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/26/2020,2.0,UNK,,,Medical History/Concurrent Conditions: Arthritis; Herniated disc,,,"['Arthralgia', 'Back pain']",UNK,PFIZER\BIONTECH, 923634,GA,40.0,F,"a red area at the injection site /growing red spot at injection site; raised area at the injection site/It was raised; irritated area at the injection site/really irritated; sore arm/arm it would wake her up with pain; itching /painful itchy growing red spot at injection site; normal pain at the injection site; there was an induration there; This is a spontaneous report from a contactable physician reporting for herself. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. Caller was a ER Physician who received her COVID 19 vaccine last Monday 21Dec2020, and was reporting adverse event at injection site. She reported a red, raised, irritated area at the injection site, stated ""thought I got bit by something"" and didn't link it to the vaccination, originally. She took Benadryl, treated it like cellulitis by using a heating pad, and applied cortisone. She stated it was persistently getting worse, even seemed worse last night. She had been taking pictures of the skin reaction and wanted to know if there was a way to submit those for follow-up/monitoring. It was also reported painful itchy growing red spot at injection site was reported as worsened. Caller had the vaccine 10 days ago, which was last Monday. She didn't notice at first. She had the normal pain at the injection site. She woke up 3-4 days later, and she felt like she got bit by something. It was a little red. It was painful, itchy, and really irritated. She paid attention to it 3 days ago. She thought this wasn't right. When sleeping on that arm it would wake her up with pain. So she would switch sides. She started taking pics of it yesterday. The redness is getting bigger. She was an Emergency Medicine Physician. She didn't have a prescribing doctor. She got it at (Institution name). She noticed it was there when she first got the shot. It felt like a normal flu shot, and she was fine. She worked out the next day. She had a sore arm like usual with any type of a shot a Tetanus shot or something. She didn't notice anything out of the ordinary until later on, and there was an induration there. It was raised, red, and kind of warm. It was painful and itchy at the same time. It was almost like if a tag in the back of clothes were rubbing it, and she couldn't move all day. There would be an irritated area there. It is getting bigger. Now it was starting to go around her arm. It was not terrible debilitating. She was not allergic to anything. She has put cortisone cream on it, but it didn't change anything. Then, last night, she tried cortisone cream and Neosporin a little later. She then put a medium hot heating pad on it for a nice chunk of the night. It was growing near her lymph nodes now. She said the vial size looked to be about 10 mL. It was a small vial. The nurse did say she could get one more dose out of that vial. She did take Benadryl to sleep at night. So she didn't feel like it was an allergic reaction. Benadryl-Unysom expiration- May2022 Lot: 20E330 Cortisone: Lot: 11885 The Cortisone's lot number was imprinted, and hard to see. The outcome of the events were not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/01/2020,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Injection site pain', 'Pain in extremity', 'Vaccination site erythema', 'Vaccination site induration', 'Vaccination site irritation', 'Vaccination site pruritus', 'Vaccination site swelling']",UNK,PFIZER\BIONTECH, 923635,IN,40.0,F,"Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; This is a spontaneous report from a non-contactable nurse who reported for herself. A 40-year-old female patient received first single dose of BNT162B2 (Pfizer/BioNTech Covid-19 vaccine, Lot number: EL0140) intramuscularly at right arm at 10:00 AM on 29Dec2020 for Covid-19 immunization. The patient received the vaccine in hospital. The patient had a history of hypothyroidism and had known allergies to sulfa. Concomitant medications in two weeks included Levothyroxine, amlodipine, losartan, drospirenone, ethinylestradiol betadex clathrate (YAZ), tizanadine, montelukast sodium (SINGULAIR), terbinafine (LAMISIL), cetirizine hydrochloride (Zyrtec). At 12:00PM on 29Dec2020, the patient developed red, raised, itchy bump at the insertion site that was warm to the touch. No treatment was received. The events had not resolved at the time of reporting. The reporter considered the events were non-serious. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,; LAMISIL [TERBINAFINE]; ; ; SINGULAIR; ; YAZ; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Hypothyroidism; Sulfonamide allergy (known allergies: Sulfa),,,"['Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site swelling', 'Vaccination site warmth']",1,PFIZER\BIONTECH,OT 923636,WA,43.0,F,Itching and diffuse hives; Itching and diffuse hives; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EL0140) as the first dose via intramuscular in the left arm on 30Dec2020 11:45 for COVID-19 immunization. Medical history included multiple allergies. Concomitant medications were not reported. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had itching and diffuse hives on 30Dec2020 12:15. Emergency department (ED) evaluation. Diphenhydramine hydrochloride (BENADRYL) and steroids prescribed. The event was reported as non-serious. The outcome of the events was recovering.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,,,Medical History/Concurrent Conditions: Allergy (multiple),,,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,OT 923637,WI,40.0,F,"dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: ej1685) for the first dose via an unspecified route of administration in the right arm on 29Dec2020 09:00 for covid-19 immunization. Medical history included diabetes, anxiety/depression, obesity and allergies to penicillin (PCN). Concomitant medications included metformin hydrochloride (MEFORMIN), glipizide, insulin glargine (TOUJEO), dulaglutide (TRULICITY), gabapentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3, event onset date reported as 29Dec2020 09:15. The events were reported as non-serious. No treatment was received for the event. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,MEFORMIN; ; TOUJEO; TRULICITY;,,Medical History/Concurrent Conditions: Anxiety; Depression; Diabetes; Obesity; Penicillin allergy,,,"['Dizziness', 'Fatigue', 'Flushing', 'Headache', 'Nausea']",1,PFIZER\BIONTECH, 923638,NY,37.0,F,"Arm soreness; headache; fatigue; myalgias; arthralgias; undetectable antibodies; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#EK9231) for the first dose via intramuscular in the left arm on 22Dec2020 12:00 for COVID-19 immunization. Medical history included post viral syndrome (COVID) or long COVID from Mar2020. The patient had undetectable antibodies in Apr2020. Concomitant medications included curcuma longa rhizome, piper nigrum fruit (TURMERIC +), colecalciferol (VITAMIN D), cobamamide (VITAMIN B12), bifidobacterium lactis (PROBIOTIC). The patient was diagnosed with COVID-19 prior to vaccination. The patient had no known allergies (NKA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not tested for COVID-19 since the vaccination. The patient had arm soreness 3 days, 1 headache, fatigue starting from night of injection increasing to requiring 1 hour nap on day 6 and 7, myalgias and arthralgias day 6 and 7; events onset date reported as 22Dec2020. Blood drawn 1 week after injection and the patient had undetectable antibodies in Dec2020, no movement in her CD4 or CD8 in T lymphocyte panel. The events resulted in doctor or other healthcare professional office/clinic visit. Events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/01/2020,,PVT,TURMERIC +; VITAMIN D [COLECALCIFEROL]; VITAMIN B12 [COBAMAMIDE]; PROBIOTIC [BIFIDOBACTERIUM LACTIS],,Medical History/Concurrent Conditions: COVID-19 (diagnosed with COVID-19 prior to vaccination),,,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Pain in extremity', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 antibody test negative']",1,PFIZER\BIONTECH,OT 923639,MI,31.0,M,Left arm soreness.; Chills and shivering on the night of the vaccine; Severe body aches and back pains; Severe body aches and back pains; Severe headaches; This is a spontaneous report from a contactable physician (patient). A 31-year-old male patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EK923) as the first dose via an unspecified route of administration in the left arm on 29Dec2020 08:00 for COVID-19 immunization. Medical history included test positive for COVID/ diagnosed with COVID-19 from Apr2020. The patient was diagnosed with COVID-19 prior to vaccination. The patient did not have COVID prior vaccination. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. And the patient did not take any other medications within 2 weeks of vaccination. The patient had COVID test post vaccination in Dec2020(also reported that the patient had not been tested for COVID-19 since the vaccination). The patient had left arm soreness; chills and shivering on the night of the vaccine; severe body aches and back pains; severe headaches; event onset date reported as 30Dec2020 02:00. The patient was tested positive for COVID in Apr2020 and symptoms felt exactly the same. All the events were reported as non-serious. No treatment was received for the events. The outcome of the events was not recovered.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,,,Medical History/Concurrent Conditions: COVID-19 (The patient was diagnosed with COVID-19 prior to vaccination),,,"['Back pain', 'Chills', 'Headache', 'Pain', 'SARS-CoV-2 test', 'Vaccination site pain']",1,PFIZER\BIONTECH, 923640,NC,27.0,F,"Generalized lymphadenopathy; This is a spontaneous report from a contactable physician reporting for herself. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number unknown) on an unspecified date at age of 27 years old (as reported), at a single dose intramuscularly in the left arm, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced generalized lymphadenopathy on 29Dec2020 06:00 am. The event was non-serious, no treatment received. The patient was recovering from the event. Information about Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/29/2020,,UNK,,,,,,['Lymphadenopathy'],1,PFIZER\BIONTECH,OT 923641,NC,35.0,F,"I woke up with my eyes ever swollen and red (only my eyelids); I woke up with my eyes ever swollen and red (only my eyelids); they were still red and painful; My eyes were slightly puffy the next morning but nothing alarming; Night sweats that were worst the night of the vaccination; This is a spontaneous report from a contactable nurse reporting for herself. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 29Dec2020 17:00 at single dose in the left arm for COVID-19 immunization. Medical history included none. No known allergies. No other vaccine in four weeks. Concomitant medication included fluoxetine hydrochloride (PROZAC). Prior to vaccination, the patient was diagnosed with COVID-19; since the vaccination, the patient had not been tested for COVID-19. The patient experienced night sweats that were worst the night of the vaccination. Her eyes were slightly puffy the next morning (30Dec2020) but nothing alarming, however, Thursday morning (31Dec2020 06:00) she woke up with her eyes ever swollen and red (only her eyelids). Thursday evening she'd been able to get the swelling down but they were still red and painful (after diphenhydramine hydrochloride (BENADRYL)). The events were non-serious. Employer and provider of vaccine had no protocol in place and said to treat it like any other reaction and go to ER if it worsened. The events were not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,PROZAC,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Erythema of eyelid', 'Eye pain', 'Eye swelling', 'Night sweats', 'Periorbital swelling']",1,PFIZER\BIONTECH, 923642,WA,60.0,M,"Tiredness; nausea; headache; chills; This is a spontaneous report from a contactable Other HCP, the patient. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26Dec2020 at 13:30 (at the age of 60-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole, montelukast, and vitamin D3, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Dec2020 at 08:00, the patient experienced tiredness, nausea, headache, and chills. The patient did not receive any treatment for the events. The clinical outcome of the tiredness, nausea, headache, and chills was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/30/2020,4.0,WRK,; ; VITAMIN D3,,Medical History/Concurrent Conditions: Migraine,,,"['Chills', 'Fatigue', 'Headache', 'Nausea']",1,PFIZER\BIONTECH, 923643,TX,48.0,F,"Arm pain at injection site; general body aches; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot: EK 5930, intramuscularly on 30Dec2020 11:30 (at the age of 48-years-old), as a single dose in the left arm for COVID-19 immunization. Medical history included penicillin and cephalosporins allergy, possible Behcet's Syndrome, allergies and COVID-19 (diagnosed prior to the vaccination). The patient was not pregnant at the time of vaccination. Concomitant medications were not reported; however, it was reported that the patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took codeine and experienced allergies. On 30Dec2020 at 20:00 on the second day (as reported), the patient experienced arm pain at the injection site and general body aches. The patient did not receive treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the arm pain at the injection site and general body aches was resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,"Medical History/Concurrent Conditions: Allergy; Behcet's syndrome; COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?: Yes); Drug allergy; Penicillin allergy",,,"['Pain', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 923644,KS,55.0,F,"Nausea; Fatigued; chilled; Massive headache; Muscle and joint pain; Muscle and joint pain; This is a spontaneous report from a contactable other HCP (patient). A 55-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in left arm on 29Dec2020 10:30 at first single dose for COVID-19 immunization. Medical history included COVID-19. Concomitant medication received within 2 weeks of vaccination included fluoxetine hydrochloride (PROZAC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient started with muscle and joint pain, within an hour had a massive headache (took ibuprofen). The next day patient began to feel fatigued, chilled, still massive headache, muscle and joint pain and nausea set in the second evening. On 31Dec2020 still had a massive headache but all other symptoms began to fade as the day went on. Currently the evening of the 31Dec2020 still a massive headache. Adverse event start date reported as 29Dec2020 01:15 AM. Events were considered as non-serious. No other treatment received for the adverse events (except ibuprofen). Since the vaccination, the patient had not been tested for COVID-19. Outcome of event headache was not recovered, of other events was recovering. Information about lot/batch number requested",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,PROZAC,,Medical History/Concurrent Conditions: COVID-19,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea']",1,PFIZER\BIONTECH,OT 923645,TX,44.0,F,"lymphadenopthy; Injection site pain; joint pain; injection site swelling and redness (about the size of a hard dollar); injection site swelling and redness (about the size of a hard dollar); This is a spontaneous report from a contactable other health professional (other HCP) reported for herself. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EK5730) via an unspecified route of administration at left arm on 30Dec2020 at 01:00 PM, at a single dose (dose number: 1) for COVID-19 immunization. Medical history included known allergies to apples, and no other medical history. The patient was not pregnant. Concomitant medications in two weeks included colecalciferol (VITAMIN D). No other vaccine received on same date. No other vaccine in four weeks. Facility where the most recent COVID-19 vaccine was administered was at hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced adverse events injection site pain, joint pain, lymphadenopthy, injection site swelling and redness (about the size of a hard dollar); all with start date on 30Dec2020 at 05:00 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: Fruit allergy (known allergies: apples),,,"['Arthralgia', 'Lymphadenopathy', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 923646,PA,30.0,M,"temperature up to 99.6 F.; Myalgias; fatigue; This is a spontaneous report from a contactable physician (patient). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231) intramuscularly at left arm on 30Dec2020 at 07:30 AM at a single dose (dose number: 1) for COVID-19 immunization. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events myalgias, fatigue, temperature up to 99.6 F; all with onset date in Dec2020. The events were non-serious. No treatment received for events. The outcome of events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/01/2020,,PVT,,,,,,"['Body temperature', 'Fatigue', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,OT 923647,NY,28.0,F,"swollen lymph nodes on neck; pain in the injection site; general body fatigue; low grade fever; mild tummy ache; body aches; This is a spontaneous report from a contactable other health professional (other-HCP) (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: brand: Pfizer; lot number: EI0142) intramuscularly at left arm on 30Dec2020 at 06:30 PM at a single dose (dose number: 1) for COVID-19 immunization. Medical history included known allergies: trees, grass, pollen, certain flowers, indoor allergens (don't know specifics). No other medical history. The patient was not pregnant. Other medications the patient received within 2 weeks of vaccination included loratadine/pseudoephedrine sulfate (CLARITIN D-12), drospirenone/ethinylestradiol betadex clathrate (YAZ) and mometasone furoate (FLONASE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events pain in the injection site, swollen lymph nodes on neck, mild tummy ache, body aches, low grade fever, general body fatigue; all occuring the day after injection, on 31Dec2020 at 06:15 AM. The events were reported as non-serious. Treatment received for events included tylenol took on 31Dec2020 at 8:40 PM. The outcome of event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,YAZ; CLARITIN-D; FLONASE [MOMETASONE FUROATE],,Medical History/Concurrent Conditions: Allergy to plants; Environmental allergy; Pollen allergy,,,"['Abdominal pain', 'Fatigue', 'Lymphadenopathy', 'Pain', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 923648,AL,36.0,F,"Fever; Injection site pain; Heart rate up; Body aches; Headache/Head face pounding; Chills; Tired; This is a spontaneous report from a contactable other HCP (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EK5730) intramuscularly at left arm on 30Dec2020 at 12:15 PM at a single dose (dose number: 1) for COVID-19 immunization. Medical history included environmental allergies only. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced fever, head face pounding, heart rate up, body aches, headache, chills, tired, injection site pain; on 30Dec2020 at 06:00 PM. The events were non-serious. No treatment received for events. The outcome of events was not recovered. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Environmental allergy,,,"['Chills', 'Fatigue', 'Headache', 'Heart rate increased', 'Pain', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 923649,CA,37.0,F,cough/wheezing cough; trouble taking a deep breath; This is a spontaneous report from a contactable Other HCP (patient). A 37-year-old female patient received BNT162B2 via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunisation. Medical history included Known allergies: Penicillin. Concomitant medication included levothyroxine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and did not have COVID tested post vaccination. The patient started with slight cough approximate 5 minutes after injection. Cough increased to a wheezing cough with trouble taking a deep breath. Cough continued to get worse for approximate 45 minutes. The events started on 28Dec2020 16:00. No treatment for events. The outcome of events was recovered. Information on Lot/Batch has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Cough', 'Dyspnoea']",UNK,PFIZER\BIONTECH, 923650,IN,58.0,F,"Left arm sore; headache; generalized muscle aches; Temp at home in evening was 101.2; This is a spontaneous report from a contactable Nurse (patient). A 58-year-old female patient receive first dose of BNT162B2 (lot number: EL1284) on left arm via an unspecified route of administration on 30Dec2020 15:45 at single dose for covid-19 immunisation. Medical history Environmental allergies, diverticulosis, uterine fibroids, and Known allergies: Broccoli and Bell peppers. The patient was previously diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (PROTONIX), levocetirizine dihydrochloride (XYZAL), famotidine (PEPCID), fluticasone furoate (FLONASE SENSIMIST ALLERGY RELIEF). The patient experienced left arm sore around 4 am 31Dec2020. Gradual onset of generalized muscle aches and headache. Worse as day progressed. Xhills late afternoon. Temp at home in evening was 101.2. The patient received tylenol (self administered) for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,PROTONIX [OMEPRAZOLE]; XYZAL; PEPCID [FAMOTIDINE]; FLONASE SENSIMIST ALLERGY RELIEF,,Medical History/Concurrent Conditions: COVID-19; Diverticulosis; Environmental allergy; Uterine fibroids; Vegetable allergy,,,"['Body temperature', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH, 923651,CA,60.0,F,"Itching but no hives; dizziness; slight headache; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received first dose of BNT162B2 (Batch/lot number: EK5730) intramuscular at Left arm, on 31Dec2020 at single dose for covid-19 immunisation. Medical history included mild Hypertension (HTN), Hypothyroidism, Anxiety, Gastrooesophageal reflux disease (GERD), Hyperlipidemia. Known allergies included Shellfish, SSRI, Demerol, Codeine. The patient did not have covid prior vaccination. Patient had no other vaccine in four weeks. Concomitant medication included lisinopril, levothyroxine, aluminium hydroxide gel, dried, magnesium carbonate (PEPCID), bupropion hydrochloride (WELLBUTRIN), atorvastatin calcium (LIPITOR), acetylsalicylic acid (BABY ASPIRIN), vitamin c [ascorbic acid], calcium, linum usitatissimum seed oil (FLAX SEED OIL), glucosamine, curcuma longa (TURMERIC), ubidecarenone (COQ 10), collagen. The patient experienced itching but no hives, slight headache, dizziness on 31Dec2020 15:30. The patient received Benadryl 25mg for the events. The patient did not have covid tested post vaccination. The outcome of events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,UNK,"; ; PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]; WELLBUTRIN; LIPITOR [ATORVASTATIN CALCIUM]; BABY ASPIRIN; VITAMIN C [ASCORBIC ACID]; ; FLAX SEED OIL; ; TURMERIC [CURCUMA LONGA]; COQ 10;",,Medical History/Concurrent Conditions: Allergy; Anxiety; GERD; Hyperlipidemia; Hypertension; Hypothyroidism; Shellfish allergy,,,"['Dizziness', 'Headache', 'Pruritus']",1,PFIZER\BIONTECH,OT 923652,WA,65.0,M,"flu like symptoms; fatigue; 98.7 temp (my baseline is 97.5); This is a spontaneous report from a contactable Other HCP. A 65-year-old male patient received first dose of BNT162B2 (Batch/lot number: EK9231) on Arm Right via an unspecified route of administration on 29Dec2020 12:00 at single dose for COVID-19 Vaccination. Medical history included cardiac history. Patient had No Known Drug Allergies. Patient did not have covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amlodipine, acetylsalicylic acid, ascorbic acid (ASPIRIN), atorvastatin. On 29Dec2020 13:00, the patient experienced flu like symptoms, 98.7 temp (my baseline is 97.5) and fatigue that lasted for approximate 8 hours. The patient did not received treatment for the events. The patient did not have covid tested post vaccination. The outcome of events was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,; ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID];,,Medical History/Concurrent Conditions: Cardiac disorder (cardiac history),,,"['Body temperature', 'Body temperature increased', 'Fatigue', 'Influenza like illness']",1,PFIZER\BIONTECH, 923653,MD,38.0,F,"Left ear felt like it was clogged - sensation of water being in her ear; This is spontaneous report from a non-contactable healthcare professional (patient). A 38-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in left arm, on 28Dec2020 14:00, at a single dose, COVID-19 immunization. The patient's medical history included allergies to sulfa. The patient's concomitant medication included lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28Dec2020 at 17:00, the patient's left ear felt like it was clogged - sensation of water being in her ear. This lasted a couple of days after receiving the vaccine. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event in Dec2020. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,['Ear discomfort'],1,PFIZER\BIONTECH,OT 923654,MN,34.0,F,"Headache; This is a spontaneous report from a non-contactable other healthcare professional. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EK9231, via an unspecified route of administration from 31Dec2020 08:30 to 31Dec2020 08:30 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache on 01Jan2021 07:30 with outcome of recovered. No treatment received. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,,,,,,['Headache'],UNK,PFIZER\BIONTECH, 923655,AZ,27.0,M,"Fatigue; Bad headaches; body/stomach aches; body/stomach aches; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on left arm on 17Dec2020 09:30 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Dec2020, the patient got the 1st dose of the vaccine in the hospital. On 28Dec2020 11:00, the patient went home from work due to bad headaches followed by body/stomach aches, and fatigue. On 01Jan2021 finally feeling a little better. Fatigue and aches have subsided, but headache still around. No treatment was given for the events. The patient underwent lab tests and procedures which included nasal swab on 29Dec2020, 30Dec2020, and 31Dec2020 and the result were all negative. The outcome of the event headache as not recovered while recovering for the other events. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/28/2020,11.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Abdominal pain upper', 'Fatigue', 'Headache', 'Pain', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 923656,CA,70.0,F,"fatigue; 102 fever; chills; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration in left arm on 29Dec2020 15:00 at a single dose for covid-19 immunization. Administration was done in a Nursing Home/Senior Living Facility. The patient's medical history was not reported. Concomitant medication included trazodone and methimazole. On 01Jan2021 at 03:00, the patient experienced fatigue, 102 fever and chills. The outcome of the events was not recovered. There was no treatment received for the events. The consumer considered the events as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,OTH,; METHIMAZOLE,,,,,"['Body temperature', 'Chills', 'Fatigue', 'Pyrexia']",1,PFIZER\BIONTECH, 923657,,31.0,F,"headache; body aches; fatigue; still was feeling achiness in the arm and wrist; still was feeling achiness in the arm and wrist; some tingling feeling in the fingertips or feet; This is a spontaneous report from a contactable pharmacist (patient). A 31-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date was unknown, via an unspecified route of administration on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if tingling in feet or fingertips a common adverse effect of the vaccine. The patient experienced headache, body aches, fatigue after receiving the shot. Yesterday at 6PM, she still was feeling achiness in the arm and wrist. She took Ibuprofen and started feeling some tingling feeling in the fingertips or feet. The outcome of the events was unknown. The following information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 923658,MI,48.0,F,"Increased fatigue; Medium to large 3-inch knot to left deltoid with increase soreness and tender to touch; Medium to large 3-inch knot to left deltoid with increase soreness and tender to touch; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL0142), via an unspecified route of administration in left arm, on 30Dec2020 08:15, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19. The patient's concomitant medications included topiramate and bupropion hydrochloride (WELLBUTRIN). The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Most recent COVID-19 vaccine was administered in the hospital. On 30Dec2020 at 4:30 PM, the patient had increased fatigue on the day of vaccination. Also, the patient had a medium to large 3-inch knot to left deltoid with increase soreness and tender to touch. No treatment was received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,; WELLBUTRIN,,Medical History/Concurrent Conditions: COVID-19,,,"['Fatigue', 'Vaccination site mass', 'Vaccination site pain']",1,PFIZER\BIONTECH, 923659,,43.0,F,"nausea; Headache; This is a spontaneous report from a non-contactable nurse. A 43-year-old female patient received bnt162b2 (BNT162B2 also reported as COVID vaccine (brand Pfizer); lot number: 5730; expiration date: unknown), intramuscular left arm on 19Dec2020 11:00 at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that the patient had headache about 2 hours (13:00) after vaccination then about 6 hours (17:00) after she had nausea. The reporter considered the events as non-serious which did not result to death, not life-threatening, or did not caused/prolonged hospitalization, disabling/incapacitating or congenital anomaly/birth defect. No treatment was received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,UNK,,,,,,"['Headache', 'Nausea']",1,PFIZER\BIONTECH,OT 923660,,,F,"swollen cervical lymph node; This is a spontaneous report from a contactable healthcare professional (patient, emergency department physician assistant). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration dates were unknown), via an unspecified route of administration on 20Dec2020 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She received her vaccine on 20Dec2020 and reported experiencing a swollen cervical lymph node 5 days later on 25Dec2020. She noted lymphadenopathy as a side effect on the Fact Sheet for the Covid 19 vaccine.Patient was asking if where was the lymphadenopathy noted in clinical trials. Outcome of the event was unknown. Information on the lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/25/2020,5.0,UNK,,,,,,['Lymphadenopathy'],UNK,PFIZER\BIONTECH, 923661,KS,36.0,F,"I have body ache; clear nasal drainage; Nasal congestion; headache; moist cough; sneezing; watery eyes; sore throat; This is a spontaneous report from a contactable nurse (patient herself). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (left arm), on 29Dec2020 at 15:15, at a single dose, for COVID-19 immunization. Relevant medical history included fibromyalgia. The patient has no known allergies. Concomitant medications included an unspecified multivitamin, cyclobenzaprine, methylphenidate, sertraline and ibuprofen. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with COVID prior vaccination. The vaccine was administered in a nursing home/senior living facility. On 01Jan2021, at 8:00 a.m., the patient experienced body ache, clear nasal drainage, nasal congestion, headache, moist cough, sneezing, watery eyes, and sore throat. The patient did not receive treatment for the events. The patient has not yet recovered from the events. The patient had a negative post vaccination polymerase chain reaction (PCR)/ nasal swab on 02Jan2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,OTH,; ; ;,,Medical History/Concurrent Conditions: Fibromyalgia,,,"['Headache', 'Lacrimation increased', 'Nasal congestion', 'Nasal discharge discolouration', 'Oropharyngeal pain', 'Pain', 'Productive cough', 'SARS-CoV-2 test', 'Sneezing']",1,PFIZER\BIONTECH,OT 923662,,,F,"throat dryness and swelling; throat dryness; This is a spontaneous report from a contactable other healthcare professional. An adult female patient (reported as 38 and 28 years old) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number number and expiry date: unknown) via an unspecified route of administration, on 23Dec2020, at a single dose, for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Covid-19 vaccine on 23Dec2020 and one hour afterwards she experienced throat dryness and swelling. She could still swallow but that the symptoms lasted about 45 minutes. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,UNK,,,,,,"['Dry throat', 'Pharyngeal swelling']",1,PFIZER\BIONTECH, 923663,,36.0,M,"vomiting; chills; This is a spontaneous report from a non-contactable physician reported for himself. A 36-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at left arm on 20Dec2020 06:45 at single dose for Covid-19 immunization. Medical history included GERD. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included omeprazole from unspecified date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient previously took ibuprofen and experienced allergies. The patient has not been tested for Covid-19 since the vaccination. On 21Dec2020 06:45 (24 hours after shot), the patient experienced vomiting and chills, lasted 4 hours (21Dec2020 10:45). The patient received treatment of promethazine for vomiting. The outcome of the events was recovered. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/21/2020,1.0,UNK,,,Medical History/Concurrent Conditions: GERD,,,"['Chills', 'Vomiting']",1,PFIZER\BIONTECH, 923664,,,F,"After covid vaccine, allergic reaction, tightness in chest wheezing; After covid vaccine, allergic reaction, tightness in chest wheezing; After covid vaccine, allergic reaction, tightness in chest wheezing; This is a spontaneous report from a contactable Pharmacist (patient) via Pfizer sales representative. A female patient of an unspecified age received BNT162B2 (Covid-19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took flu vaccine for Immunization and experienced this type of reaction, allergic reaction, tightness in chest wheezing. The patient also experienced allergic reaction, tightness in chest wheezing after COVID vaccine, and went to emergency room. Outcome of the events was not reported. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Allergy to vaccine', 'Chest discomfort', 'Wheezing']",UNK,PFIZER\BIONTECH, 923665,,,M,"still experiencing a low grade fever; This is a spontaneous report from a contactable nurse (patient herself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration, on 31Dec2020, at a single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated he received the vaccine on 31Dec2020, and he is still experiencing a low-grade fever. He wanted to know if this is expected. He would also like to know how long this side effect usually last. Outcome of the event was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,,,UNK,,,,,,['Pyrexia'],UNK,PFIZER\BIONTECH, 923666,CA,35.0,F,"fatigue; Yellow urine; injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 35-year-old female patient received the first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: BL0142), intramuscular on the left arm on 31Dec2020 at 19:30 at a single dose for immunization. Medical history was not reported. There were no concomitant medications. The patient had no other vaccine in four weeks, no Covid prior vaccination and has not been tested positive for Covid post vaccination. The patient had yellow urine, injection site pain, and fatigue on 01Jan2021, and received Tylenol or ibuprofen as treatment for the events. The events had not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PHM,,,,,,"['Chromaturia', 'Fatigue', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 923667,,,U,"I have a 101 fever; I am not really feeling well; This is a spontaneous report from a contactable consumer (patient herself). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK923; expiry date: Apr2021) via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced 101 fever and was not really feeling well. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Body temperature', 'Malaise', 'Pyrexia']",UNK,PFIZER\BIONTECH, 923668,AK,58.0,F,"Headache; My arm is sore; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (BNT162B2, batch number:5926710001), intramuscular in the arm on 30Dec2020 at a single dose for covid-19 immunisation. The patient's medical history included bacterial infection from an unknown date and unknown if ongoing. There were no concomitant medications. On 30Dec2020, the patient got the vaccine and had a little headache and her arms were sore. The outcome of the events was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,,,UNK,,,Medical History/Concurrent Conditions: Bacterial infection,,,"['Headache', 'Pain in extremity']",UNK,PFIZER\BIONTECH,OT 923669,PA,36.0,F,"Fever started around noon with body aches , chills, and a headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,,,hypertension,,Wine,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 923670,,36.0,F,"Rapid heart rate approximately 1 hr after administration of vaccine.; This is a spontaneous report from a non-contactable other HCP (patient). This 36-year-old female other HCP reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular at right arm on 29Dec2020 at single dose for COVID-19 immunization. Facility type of vaccine was hospital. Medical history included known allergies to shrimp. Concomitant medication included lamotrigine. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Patient experienced rapid heart rate approximately 1 hr after administration of vaccine on 29Dec2020. No treatment was received. It was reported as non-serious. Outcome of event was recovered in Dec2020. No follow-up attempts are possible.; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Shellfish allergy,,,"['Heart rate', 'Heart rate increased']",1,PFIZER\BIONTECH,OT 923671,CA,39.0,F,"Puffy eyes. Right more than left; This is a spontaneous report from a contactable other-HCP. This 39-year-old female other-HCP (patient) reported for herself that she received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscularly at left arm at single dose for COVID-19 immunization on 30Dec2020 02:00 PM. Relevant medical history was none. Relevant concomitant drug was unknown. The patient experienced puffy eyes, right more than left on 30Dec2020. The event was assessed as non-serious. No treatment was received for the event. Outcome of event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Periorbital swelling'],1,PFIZER\BIONTECH,OT 923672,,,U,"Myalgias; Malaise; Mils fever; Sore throat; Headache; Fatigue; This is a spontaneous report from a non-contactable consumer via Pfizer Sales Representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not available), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced Myalgias, Malaise, Mils fever, Sore throat, Headache, Fatigue on unspecified dates. Events took place after use of product. These symptoms were expected symptoms but took longer than expected. The patient was no longer experiencing the symptoms. The outcome of the events was recovered on unspecified dates. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Oropharyngeal pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 923673,TX,53.0,F,"Muscle pain; Got little ache in the back; Joint pain; Fever; Chills/felt like chills like when you feel cold; arm be sore from the shot; This is a spontaneous report from a contactable consumer (Patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Nursing Home. Medical history included Blood pressure high. Concomitant medications included metoprolol for Blood pressure high, potassium. The patient had got her COVID-19 Vaccine yesterday (29Dec2020) and now (30Dec2020) she had a little muscle pain, guess from the arm. She got the shot in her muscle yesterday. Today (30Dec2020), spiked a little fever, and she got a little muscle pain, joint pain. She felt good, she just got little ache in the back. She took some Tylenol, it has all worked today. The patient also experienced ""arm be sore from the shot"". She got a little chill that's why she took the Tylenol. she had a little fever, she caught fever or felt like chills like when feel cold. Therapeutic measures were taken as a result of ache in the back, fever, and chills included Tylenol. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,OTH,;,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Arthralgia', 'Back pain', 'Chills', 'Myalgia', 'Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH, 923674,MI,,M,"Sore arm; chills; headache; fatigue; body aches; This is a spontaneous report from non-contactable consumer (patient's wife) via Pfizer Sales Representative. A 31-year-old male patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for covid-19 immunization. None medical history. The patient with no known underlying health conditions. The patient's concomitant medications were not reported. The patient experienced Sore arm, chills, headache, fatigue and body aches within 24 hours after first vaccine injection on 31Dec2020. It was reported patient experienced stated symptoms yesterday 31Dec2020, after receiving Pfizer Covid 19 vaccine. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/31/2020,30.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 923675,TN,56.0,F,"Headache; Chills; Muscle ache; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 29Dec2020 10:30 at single dose for preventive measure of COVID. Medical history included hypertension. Concomitant medication included atenolol at 50 mg for hypertension. Consumer stated, ""It is Pfizer! I am having side effects, I started this morning. I am having the headache, chills and muscle ache, just feel like I have a flu but I don't. I have received the vaccine yesterday from my job, yesterday at 10:30. I think I got all the symptoms like the dizziness, fatigue, headache and muscle ache."" Consumer stated, ""I just took some Aleve"" as treatment. The outcome of events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,UNK,,,Medical History/Concurrent Conditions: Hypertension,,,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Weight']",UNK,PFIZER\BIONTECH, 923676,PA,65.0,F,"stated that she is having chills; stated that her arm is harsh; stated that her arm is sore; This is a spontaneous report from a contactable nurse reported for herself. A 65-year-old female patient received bnt162b2, via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history included covid-19 from Apr2020 to an unknown date. She further stated that she had COVID back in April and survived. Stated that she had the pneumonia part of it and went back to work in June. The patient's concomitant medications were not reported. On an unknown date, patient was having chills since she had the shot. Stated that her arm was harsh and feels real sore. Patient wanted to know if the chills were common. The outcome of the events was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,,,UNK,,,Medical History/Concurrent Conditions: COVID-19 (Stated that she had COVID back in April and survived.); Pneumonia,,,"['Chills', 'Limb discomfort', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 923677,IL,47.0,F,"Fever; fatigue; uncontrolled headache; eye pain; chill; joint pain; nausea; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on the left arm on 02Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included COVID on an unspecified date. The patient's concomitant medications were not reported. The patient stated, ""fever, fatigue, uncontrolled headache, eye pain, chill, joint pain. nausea. Get more worst and worst"". The patient received treatment. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Arthralgia', 'Chills', 'Eye pain', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,OT 923678,IN,56.0,F,"resembles a cellulitis to her/ red hot rash spreading on her left arm stated it was the same arm she got in injection; This is a spontaneous report from a contactable nurse reporting for herself. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231) via an unspecified route of administration (left arm), on 28Dec2020, single dose, for COVID-19 immunization. Relevant medical history and concomitant medications was provided as none. After the patient received the COVID shot few days ago, the patient had a cellulitis reaction to it on 30Dec2020. It resembles a cellulitis to her, a red hot rash spreading on her left arm, stated it was the same arm she got in injection. Cellulitis was reported as worsened. The patient would like to know when she gets the next vaccine if she should alternate arms and get it in the other arm. Outcome of the event was not recovered. The event was assessed by the reporter as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No",,,['Vaccination site cellulitis'],UNK,PFIZER\BIONTECH, 923679,WA,60.0,F,"hand was swollen and itchy on the same arm where the injection was; back of hand was swollen and itchy on the same arm where the injection was; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration (Deltoid Right) from 26Dec2020 15:00 at single dose for Covid-19 immunization. The patient's medical history included chronic pain and insomnia. Concomitant medications included hydrocodone and temazepam. The patient reported, ""On 26Dec2020 I got my first immunization for COVID and today (30Dec2020) I woke up and the back of my hand was swollen and itchy on the same arm where the injection was"". The patient further stated ""It never have happened before I don't have any reaction at the injection site but it was kind of odd that it kind of showed up on the back of my hand, it feels like an allergy kind of thing."" The patient tried the Voltaren Gel to try and get the inflammation down, but it didn't help, and she took some Benadryl it doesn't seem to help much. The patient's next shot is due on ""12Jan2021"". The outcome of events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/30/2020,4.0,UNK,;,,Medical History/Concurrent Conditions: Chronic pain (Verbatim: Chronic pain); Insomnia (Verbatim: Insomnia),,,"['Peripheral swelling', 'Pruritus']",UNK,PFIZER\BIONTECH, 923680,SD,62.0,F,"Feeling unwell; Headache; Tiredness; Muscle pain; Chills; Nausea; Injection site pain; had been asleep most of the whole day; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: Arp2021), via an unspecified route of administration on 30Dec2020 at single dose at right arm for Covid virus. Medical history included blood thinner treatment. Concomitant medication included ongoing apixaban (ELIQUIS) for blood thinner treatment. The patient previously took coumadin, warfarin. Patient received the Covid-19 vaccine yesterday. She had been asleep most of the whole day (Dec2020). She had injection site pain, headache, tiredness, muscle pain and chills. She thought she was going to work but that didn't work. She was currently taking Eliquis. She had been on coumadin and warfarin before. She looked at the different medications that needed to be reported. She would also call her physician and make her aware. The start date for ""Injection site pain"" was 30Dec2020. The start dates for headache, tiredness, muscle pain and chills all were 31Dec2020. The patient also experienced nausea, feeling unwell on 31Dec2020. Investigation assessment was no. The outcome of the event ""Injection site pain"" was not recovered. The outcome of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/01/2020,,PVT,ELIQUIS,,Medical History/Concurrent Conditions: Anticoagulant therapy,,,"['Chills', 'Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Nausea', 'Somnolence', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 923681,CT,,F,"Nausea; Fatigue; Head fog; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included the patient already had Covid 'more than 90 days ago'. The patient's concomitant medications were not reported. The patient experienced nausea, fatigue, head fog on an unspecified date. The outcome of the events was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PVT,,,Medical History/Concurrent Conditions: COVID-19 (more than 90 days ago),,,"['Fatigue', 'Feeling abnormal', 'Nausea']",UNK,PFIZER\BIONTECH, 923682,CT,,F,"Dizziness; This is a spontaneous report from a contactable consumer. A 6-decade female patient in early 50's started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Dec2020 (about 5 to 7 days before 30Dec2020) at single dose for covid-19 immunization. The facility type vaccine was hospital. The patient medical history and concomitant medications were not reported. The patient has not had Covid prior to the vaccine. The patient experienced has been experiencing dizziness on and off in Dec2020 since she was given the vaccine. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,PVT,,,,,,['Dizziness'],UNK,PFIZER\BIONTECH, 923683,,,M,"shivers; cold feeling; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9321), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller was reporting on the COVID vaccine. He received the first shot yesterday (30Dec2020) and had experienced shivers and cold feeling in Dec2020. He wanted to know if this was normal. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/01/2020,,UNK,,,,,,"['Chills', 'Feeling cold']",1,PFIZER\BIONTECH, 923684,OR,38.0,F,"Shortness of breath; Sore arm like she got kicked in the arm by a horse. Her arm felt like this today.; Chest pain; Headache; Body aches; Fever; Chills; fatigued; feels cold; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (lot number: EL3246), via an unspecified route of administration, at deltoid right, on 30Dec2020 07:45, at single dose, for COVID-19 immunization. Medical history included chronic asthma from an unspecified date, stomach surgery a year and a half ago, sometimes has stomach pain that feels like chest pain since her stomach has been surgically altered. Has had asthma stuff since she was very young. Is relatively healthy. No family medical history. No relevant tests. The patient's concomitant medications were not reported. No additional vaccines administered on same date of Pfizer suspect. No prior vaccinations within 4 weeks. The patient previously took flu vaccine on 01Oct2020 and experienced fatigued, tired, and sore arm like she got kicked in the arm by a horse. It was reported that received COVID-19 vaccine yesterday (30Dec2020). Been having some chest pain. Started a couple hours after receiving the COVID-19 Vaccine. Chest pain doesn't whole heartedly go away. Gets more intense and then relaxes. Wants to know if this is common or something she just has to deal with. Doesn't know if this is stomach pain. Had stomach surgery a year and a half ago. Sometimes has stomach pain that feels like chest pain since her stomach has been surgically altered. Has been taking heartburn and gas medications. Chest pain is not going away. Wants to know if this is common. Tried to look online and only found common side effects. Her husband looked it up and two people died from a heart attach after receiving the COVID-19 Vaccine. She is getting older, but is not that old. Caller works in behavioral health. Had an instant headache. Clarified chest pain: Is always lingering in the background. Doesn't fully go away. Comes and goes in waves. Gets intense and relaxes. Chest pain was pretty sharp this morning and it made her short of breath. Doesn't know if it was the pain that took her breath away. Occurred at 10:00. Indication: Has older people she takes care of. Her mother is super frail and has dementia. Her uncle is elderly and has heart issues. Wants to do her part so she doesn't catch it. No further details provided. In regards to the two people who had heart attacks and died after COVID-19 Vaccine, caller has no patient identifiers or NDC/Lot/Exp to provide. Stated this people were in the UK and the information was just something her husband read on the internet. Also experienced body aches, fever, and chills between 14:30 and 15:00 yesterday, 30Dec2020. Is super fatigued. Doesn't know if she is febrile, hasn't checked temperature. Still feels cold and has chills today. Does not have a headache today. It was also reported that fatigued and tired with Flu Vaccine (historical vaccine). Sore arm like she got kicked in the arm by a horse. Her arm felt like this today (31Dec2020). Therapeutic measures in response to chest pain is received, treatment included heartburn and gas medications. Gas medication is Equate brand Simethicone Extra Strength Gas Relief (NDC: 49035-487-02, Lot:H22016, Exp: Sep2022) at 125mg liquid-gel. Heartburn medication is Equate brand Cimetidine 200mg tablet (NDC: 49035-820-72, Lot: Doesn't know if lot number is OJE2445C or 0JE2445C, Exp: Jun 2022). Stated writing is so tiny. Gas and heartburn medication has not helped with chest pain. The outcome of the event chest pain was not recovered, of the other events were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/01/2020,,PVT,,,Medical History/Concurrent Conditions: Asthma chronic (asthma stuff since she was very young); Stomach pain (Sometimes has stomach pain that feels like chest pain since her stomach has been surgically altered.); Surgery (Had stomach surgery a year and a half ago.),,,"['Chest pain', 'Chills', 'Dyspnoea', 'Fatigue', 'Feeling cold', 'Headache', 'Pain', 'Pyrexia', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 923685,,,F,"Heart rate high; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had a question about the COVID 19 vaccine. She wanted to know if it was possible for it to cause an extremely high heart rate. She got her first dose on Monday (in Dec2020) and had to go to the emergency room for a high heart rate. After 48 hours it went back to normal. She stated she didn't think she was going to get the second shot because of this. The patient is a healthcare worker, a nursing assistant and it was (Pharmacy name) gave her the vaccine. The outcome of the event was recovered in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Heart rate', 'Heart rate increased']",1,PFIZER\BIONTECH, 923686,NM,27.0,F,"Diarrhea; throwing up; very bad migraines; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration on 27Dec2020 at single dose shot left arm once for COVID-19 immunization in hospital. The patient's medical history and concomitant medications reported as no. Patient stated that she got her Covid vaccine on Sunday (27Dec2020) and had experienced very bad migraines on 27Dec2020, diarrhea and throwing up as well on 29Dec2020. Stated that the diarrhea was not as common as the migraines. Stated that she had not thrown up but did last night (30Dec2020) at 2 AM. Investigation Assessment reported as no. No treatment was received for the events. The outcome of event migraines was unknown, outcome of the other events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Diarrhoea', 'Migraine', 'Vomiting']",1,PFIZER\BIONTECH, 923687,NV,80.0,F,"she started to get very sick, which continued to worsen until nowwhen she feels like she is improving; had stomach and abdominal pains; had stomach and abdominal pains/stomach is still very sensitive; loose stool; she was very tired; Pain or little discomfort in the arm she received the injection; Pain or little discomfort in the arm she received the injection; This is a spontaneous report from a contactable consumer (Patient). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, EH9896), via an unspecified route of administration to very top of right arm on 22Dec2020 at single dose for covid-19 immunization. It was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included glaucoma she had drops to take for, mostly she just has problem with her joints and her back with her age. She did not have any diseases or anything; she was not diabetic, nothing like that. There were no concomitant medications. She was administered her first dose of COVID-19 Vaccine on 22Dec2020. She reported that the pain or little discomfort she had in the arm she received the injection in disappeared by 25Dec2020. But on 24Dec2020 she started to get very sick, which continued to worsen until now when she felt like she was improving. She did not know if these events could have something to do with the COVID-19 Vaccine. Pain or little discomfort in the arm she received the injection: Right arm. Everyone warned her that the site would hurt, so she was really glad when it totally went away on 25Dec2020 and thought that it was over; any issues from the injection. Very sick: this event started to get bad on 24Dec2020, she was very tired and not very hungry, she had stomach and abdominal pains and loose stool; 25Dec2020 those symptoms were worse. It was Christmas so she cooked and thought at first maybe she got carried away baking pies; because that evening she started to have pain and did not each much. 26Dec2020 it was worse; she said she was going to work on 27Dec2020; it was terrible because she was stuck for 12 hours trying to work while very sick. She called off of work 28Dec2020 and 29Dec2020. Since then she has stayed home and still has pain but she took her ranitidine delayed release 100mg twice daily as needed for stomach pain as given to her by her doctor, and is now down to just once daily. She did not know what she would have done without the ranitidine. She did not have any more abdominal pain, but her stomach was still very sensitive. She was tired but thought she was going to be ok. She was scared to get the second scheduled dose of COVID-19 Vaccine because she thought the side effects will be more severe with the booster shot. She just needed to rest and stay home which she has been doing. She has not had any fever. She has not notified her family doctor of these events. There was nothing she did on Christmas that she could think of other than she drank a glass of champagne because she did not know her stomach was going to be so bad. The outcome of the events Pain or little discomfort in the arm she received the injection was recovered on 25Dec2020, the outcome of event sickness was recovering, the outcome of the event Abdominal pain was recovered on an unknown date in Dec2020, the outcome of event stomach pain was not recovered, the outcome of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Back disorder NOS (has problem with her joints and her back with her age); Glaucoma (she had drops to take for.); Joint disorder NOS (has problem with her joints and her back with her age),,,"['Abdominal pain', 'Abdominal pain upper', 'Diarrhoea', 'Fatigue', 'Illness', 'Vaccination site discomfort', 'Vaccination site pain']",1,PFIZER\BIONTECH, 923688,,,F,"Injection site swelling and redness; increased warmth at injected site; Injection site swelling and redness; increased warmth at injected site; Injection site swelling and redness; increased warmth at injected site; This is a spontaneous report from a contactable consumer (patient husband). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated he know it's one of the possible mild side effect is injection site swelling and redness and what about increased warmth at injected site. He asked if it is normal to have. He know it says injection site swelling and also Injection site redness but what about like warmth like increase warmth, heat at injection site. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown. Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities. Lot/batch number has been requested in follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Vaccination site erythema', 'Vaccination site swelling', 'Vaccination site warmth']",UNK,PFIZER\BIONTECH, 923689,,,U,"Muscle pain in my back, legs; Hard for me to walk; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer stated, ""I am calling for the side effects of the Vaccine, I am calling to see about it."" When probed to clarify if consumer wanted to know about the side effects of COVID Vaccine, consumer stated, ""Yes, because I am having muscle pain in my back, legs and it's hard for me to walk."" The outcome of the events was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Gait disturbance', 'Myalgia']",UNK,PFIZER\BIONTECH, 923690,NJ,64.0,F,"Rash on lateral breasts/felt a bit of itching.; blotchy rashes; Itchiness on Scalp; broke out in hives/welts came up on right ear and behind neck/welts under buttocks and behind knees, welts were large and red; Slight chills; Tenderness in injection arm; was just a little cold; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: PAA156571), via an unspecified route of administration in left deltoid on 28Dec2020 10:00 at 0.3 mL single for covid-19 immunization; sulfamethoxazole, trimethoprim (BACTRIM DS), at twice a day for 10 days for perineal cyst. The patient was on her last day of sulfamethoxazole, trimethoprim on the day she got the COVID-19 vaccine (28Dec2020). Medical history included perineal cyst, COVID-19 in Apr2020 with no problem, only had a cough. Husband had COVID-19 and had loss of taste and smell, had fever, but he was not serious. Both her and her husband got tested for antibodies and were positive. Family medical history was none. The patient had unspecified flu vaccine (Lot: UJ428AB) on 18Dec2020 injected in left deltoid in two weeks prior to COVID-19 Vaccine. Checked with three different people who stated the Flu vaccine would not interfere with COVID-19 Vaccine. Checked with two pharmacists who stated Bactrim DS would not affect her taking the COVID-19 Vaccine. She received COVID-19 Vaccine through her work in a nursing home. There were no additional vaccines administered on same date of Pfizer suspect. On 28Dec2020 about 7 to 8 hours after vaccination, patient had slight chills and tenderness in her arm: was just a little cold. Thirty-six hours after injection, midnight on 29Dec2020, her scalp itched like crazy, broke out in hives. On 30Dec2020, rash developed on both lateral sides of her breast, welts came up on right ear and behind neck. On 31Dec2020, welts under buttocks and behind knees, welts were large and red. Rash on lateral breasts: felt a bit of itching. The patient had blotchy rashes, rash up in her hair above her neck and back of ear, had intense itching; which subsided. It was a little pink on her chest, little itching on her head. Her ear was better. Symptoms were most mild because she was still able to function. Clarified as not serious. The patient was taking diphenhydramine (BENADRYL, Lot: SMF011, Exp: May2022) at 25mg every 3.5 to 4 hours, cortisone cream 10 Maximum Strength (Lot: 20K434, Exp: Sep2023) for rash and welts; and doing tepid soaks. It was tolerable and faded. Rash had subsided, but was a little red. Her greatest concern was what to do in regards to the second dose in three weeks. The reporter considered events were related with COVID-19 Vaccine. The action taken in response to the events for sulfamethoxazole, trimethoprim was unknown. The outcome of events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/28/2020,10.0,WRK,BACTRIM DS,Perineal cyst,Medical History/Concurrent Conditions: Cough; COVID-19 (Only had a cough.),,,"['Chills', 'Feeling cold', 'Pain in extremity', 'Pruritus', 'Rash macular', 'Rash pruritic', 'SARS-CoV-2 antibody test', 'Urticaria']",1,PFIZER\BIONTECH, 923691,FL,,F,"whole family started to get sick and experiencing same things she experienced (chills, not feeling well); whole family started to get sick and experiencing same things she experienced (chills, not feeling well); This is a spontaneous report from a contactable consumer (patient's daughter). This consumer reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller reported her mom received COVID vaccine on the 23Dec2020. On the 29Dec2020, her whole family started to get sick and experiencing the same things she experienced (chills and not feeling well). The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/29/2020,6.0,UNK,,,,,,"['Chills', 'Malaise']",UNK,PFIZER\BIONTECH, 923692,,,U,"Really bad dizziness; Headache; This is a spontaneous report from a contactable consumer(patient). A patient of an unspecified age and gender received first dose BNT162B2, via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient got the vaccine today, the first dose, and the patient just had really bad dizziness and headache ever since in Dec2020. The patient was reading the side effects and it said that it can be a severe reaction. The patient didn't have any of the other severe side effects. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Dizziness', 'Headache']",1,PFIZER\BIONTECH, 923693,MN,,F,"Developed UTI symptoms of burning in urination and frequency and urgency; Developed UTI symptoms of burning in urination and frequency and urgency; Developed UTI symptoms of burning in urination and frequency and urgency; Developed UTI symptoms of burning in urination and frequency and urgency; This is a spontaneous report from Pfizer-sponsored program. A contactable Other HCP reported for a nurse (patient). An adult female patient received bnt162b2 (batch/lot number and expiration date not provided), via an unspecified route of administration, first dose on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter has a patient and the patient is having the symptoms of UTI after the patient got the first dose of COVID-19 vaccine on Monday. The patient who is a 30 year old female (Age at the time of adverse event was not confirmed) who got her vaccine on Monday. She is a nurse and she developed urinary tract infection (UTI) symptoms of burning in urination and frequency and urgency and a urine sample was sent for evaluation, if it is positive the patient was wondering if the vaccine response would be altered by taking antibiotics for UTI. The outcome of the events was unknown Information on the lot/batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Dysuria', 'Micturition urgency', 'Pollakiuria', 'Urinary tract infection', 'Urine analysis']",1,PFIZER\BIONTECH, 923694,LA,38.0,F,"Was diagnosed with the COVID-19 virus after receiving the COVID-19 Vaccine on 18Dec2020; Was diagnosed with the COVID-19 virus after receiving the COVID-19 Vaccine on 18Dec2020; This is a spontaneous report from a contactable Other Health Professional (patient) from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 38 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Dec2020 at single dose in Deltoid Right for COVID-19 immunization. Medical history and concomitant medications were none. After receiving the COVID-19 Vaccine, the patient was diagnosed with the COVID-19 virus on 28Dec2020. she saw Dr. at the clinic where she works to seek treatment. She stated she is supposed to receive the 2nd dose of the COVID-19 Vaccine on 08Jan2021. She asked now that she is COVID-19 positive, should she get the 2nd COVID-19 Vaccine dose. Reported she had a rapid nasal swab COVID-19 test performed. Reported she is taking Hydroxychloroquine and a bunch of vitamins for treating COVID-19. Caller stated she did not have the COVID-19 Vaccine card with her to provide the Lot Number. The patient underwent lab tests and procedures, which included COVID-19 rapid POC test with positive result. Outcome of event was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID-19 based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/28/2020,10.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 923695,TN,59.0,F,"It is warm; Even up to the back of the shoulder to the neck is painful; Even up to the back of the shoulder to the neck is painful; Her whole arm is sore up to her neck and down the arm/It is very painful/it throbs; Last night she was up all night, every 3 hours; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiration date Apr2021), via an unspecified route of administration at left arm on 30Dec2020 09:30 at single dose for COVID-19 immunization, at a hospital. The vaccine was not administered at military facility. The patient's medical history included ongoing asthma from 2005 (diagnosed 15 years ago) and allergies. For asthma She has ProAir rescue inhaler to use as needed. Breo inhaler she uses at night. She has been on it for 2 years. She has been on different inhalers. Family medical history relevant to events was reported as none. Concomitant medication included montelukast sodium (SINGULAIR) from 2005 (had been on it probably 15 years) and ongoing at 10 mg, daily for allergies; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) inhaler via resp Inhalation from 2018 (has been on it for 2 years), uses it at night, for asthma; and salbutamol sulfate (PROAIR HFA) rescue inhaler via resp Inhalation, to use as needed for asthma. The patient had no history of previous immunization with the Pfizer vaccine. For historical vaccine, the patient received Tetanus for immunization and had allergic to Tetanus, her arm swelled and she couldn't move it (which was kind of like this, but not as severe). She didn't know the brand name for the tetanus vaccine she had reaction to. She didn't have NDC, lot, or expiry. It was 40 years ago. She had the reaction when she was 18 years old. There was no vaccine administered on same date of the Pfizer suspect, and tno vaccinations within 4 weeks prior to the Pfizer suspect. It was reported that last night (30Dec2020) she was up all night, every 3 hours. She was taking Advil. Her whole arm was sore up to her neck and down the arm. She had a nurse look at it this morning (31Dec2020) and it was not red. It was warm and it throbs. No rash. It was very painful. Even up to the back of the shoulder to the neck was painful. Her arm being sore and painful was ongoing at the time of report. She had been taking Advil. The pain had stayed the same even with the Advil. The events started probably between 14:00 and 14:30, it started off sore then became more painful. At the time of reporting, she was not at home and didn't have the bottle to provide NDC, lot, and expiry for Advil. She was taking some at the office, but that was in a travel bottle and didn't have the lot, expiry, and NDC. No emergency room or physician office visit. Relevant tests was none. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,SINGULAIR; BREO ELLIPTA; PROAIR HFA,Asthma (diagnosed 15 years ago),Medical History/Concurrent Conditions: Multiple allergies,,,"['Arthralgia', 'Feeling hot', 'Neck pain', 'Pain in extremity', 'Poor quality sleep']",1,PFIZER\BIONTECH, 923696,,,F,"Short of breath; Heartbeat is fast; Feels like she has some swelling; This is a spontaneous report from a non-contactable consumer. This consumer reported for a 30-year-old female patient (daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 31Dec2020 11:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine today at her place of work and at the moment she did not have any side effects. But now during the night she was feeling short of breath and her heartbeat was fast and she felt like she has some swelling and some other more severe side effects that were put on the paperwork and reporter was wondering she was not acutely ill in spite of being short of breath. But she was worried about if she could get worse. So, would it be wise for reporter to give her Benadryl if this is an allergic reaction. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,UNK,,,,,,"['Dyspnoea', 'Heart rate increased', 'Swelling']",UNK,PFIZER\BIONTECH, 923697,MN,49.0,F,"Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat was fast; Felt like she had to throw up; Pain in right arm; Does not feel good; It felt like there was oil in her mouth; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 via an unspecified route of administration on 30Dec2020 10:45 at single dose in right arm for COVID-19 immunization. The vaccination was given in hospital, not a military facility, at 10:45 and left hospital at 11:05 on 30Dec2020. Prior vaccinations within 4 weeks was none. Additional vaccines administered on same date of the Pfizer suspect was none. Medical history included ongoing migraine and family medical history included mother has high blood pressure and father has diabetes. Concomitant medication included verapamil from Oct2020 at 40 mg twice daily by mouth for migraine. Additional Information for concomitant products Verapamil included 1 for one week, 2 for second week 3rd week 3 and after 3 months, then came back down to 2. The patient experienced does not feel good at 11:30 on 30Dec2020. She was driving and did not feel good. She felt like she had to throw up at12:00 on 30Dec2020 and had it all night until she went to bed. Eyes were red when she woke up at 23:30 on 30Dec2020, that's when she first noticed. Heartbeat was fast around 12:30 on 30Dec2020. Tiredness and needed to sleep extra at 17:00 on 30Dec2020. Pain in right arm at 12:00 on 30Dec2020. When she went to drink something, she noticed her arm was painful. No ER or physician's office required. Received call from patient regarding the COVID vaccine. She received it on 30Dec2020 (yesterday) and was a healthcare worker. She later stated she works in patient transportation in a hospital. She did not feel good. Yesterday, she felt like she had to throw up. When she slept, she felt very tired and when she woke up, her eyes were red. She washed her face when she woke up around 11. Then she noticed her heart beat was kind of fast. She took another medication she takes all the time. Her doctor said that she can take it with it but she was not sure. She did not feel herself. Yesterday after she took it, she had to wait there for 15 minutes. It felt like there was oil in her mouth. She just drank water and came home. When she came home, her heart beat was fast. She had to sit down. She liked to eat spicy food, and she needed to sleep. Her kids said she never slept like this. Both eyes were red, red like blood. Her daughter told her to go look at them in the mirror. There was no pain or nothing in her eyes, they were just red and they improved today. If she goes to bed now, she can sleep, but she just wakes up and drinks tea and wants to wake up. She didn't want to sleep, but she felt like she could. Regarding the pain in her right arm, she had to hold her shoulder when she first woke up. It was worse then, but it's better now that she keeps moving it. She has 3 more weeks to get the next dose of the COVID Vaccine. Hopefully it will be this shot only and she can go back to work. She planned on going back to work on Saturday. She would like to know if she can continue to take Verapamil. She will call her pharmacy to find out. The outcome of the events does not feel good and tiredness and needed to sleep extra was not recovered. The outcome of the events felt like she had to throw up, eyes were red, heartbeat was fast and pain in right arm was recovering. The outcome of the other event was unknown. Information on Lot/Batch Number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure increased (Mother); Diabetes (father); Migraine,,,"['Fatigue', 'Feeling abnormal', 'Heart rate', 'Heart rate increased', 'Malaise', 'Ocular hyperaemia', 'Somnolence', 'Vaccination site pain', 'Vomiting']",1,PFIZER\BIONTECH, 923698,MS,,U,"Fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown), via an unspecified route of administration on 28Dec2020 09:00 at single dose for covid-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient calling concerning the vaccination, the patient received vaccination on this past Tuesday which was 28Dec2020 and the patient had recently just recovered from Covid and the patient asked the person giving her/him the vaccination it was okay since the patient just recovered from Covid to have it. She said yes. The patient could have it. Since last Tuesday (28Dec2020) the patient got the vaccination at 9 AM in the morning. The patient did fine all during the day. That night the patient started to run fever (in Dec2020) and the patient kept on fever all of that night, yesterday (30Dec2020) and today (31Dec2020) and the patient was just curious if this was normal. Yesterday (30Dec2020) because the patient thought may be she/he should go have the test again for Covid, the patient's normal nurse practitioner, doctor said no, but the patient probably shouldn't take the second vaccine, so that's what the patient's question is and the patient what to know if there are going to have an adverse reaction. The patient underwent laboratory test included only the Covid test on an unspecified date. The outcome of the event was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/01/2020,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Pyrexia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 923699,,47.0,F,"Headache; Sore throat; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient had a vaccine received this afternoon on 30Dec2020, 4 to 5 hours after, she was having a headache and had sore throat as well. The patient wanted to know if it was okay to take Tylenol. The outcome of events was unknown. No follow-up attempts are possible; Information on Lot/Batch Number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Headache', 'Oropharyngeal pain']",UNK,PFIZER\BIONTECH, 923700,NJ,,M,"Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). An adult male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date unknown), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient experienced soreness at injection site in Dec2020. Since the vaccination, it was unknown had patient been tested for COVID-19. The outcome of the event was unknown. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 923701,NY,,U,"I think it helps in my pain that I used to have; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0140), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunization. Medical history included pain from an unknown date. The patient's concomitant medications were not reported. The patient got the vaccine on 29 and just at the site where patient got the needle, that is it and right now, it actually be going away, patient put hand up on it and didn't even feel it, patient was not throwing up, have no headache, no body ache. Patient was doing fine so far it is just 2 day, patient was not in any pain. Actually, patient think it help in pain that patient used to have. The occurrence date was Dec2020. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: Pain,,,['Therapeutic response unexpected'],UNK,PFIZER\BIONTECH, 923702,,,F,"Stiff neck; soreness in my arm; severe pain in neck; squeezing on a nerve; pain came from up head, under my clavicle and down my back.; pain came from up head, under my clavicle and down my back.; pain came from up head, under my clavicle and down my back.; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. When the patient tried to turn around to speak to nurse (reporter), she complained of a stiff neck. The patient had the same symptoms as nurse (reporter). The nurse stated ""I got the Covid vaccine on 18Dec2020 and had soreness in my arm that was gone by the next day. On 23Dec2020, while driving home driving home, I felt severe pain in neck. I almost felt like something went up in my neck and started squeezing on a nerve. It proceeded to get bad so I took muscle relaxants. Christmas day was horrible, I couldn't lift my head off my pillow. The pain came from up head, under my clavicle and down my back. "" The outcome of events was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Back pain', 'Bone pain', 'Headache', 'Musculoskeletal stiffness', 'Neck pain', 'Nerve compression', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 923703,,,U,"severe pain in neck; squeezing on a nerve; soreness in my arm; pain came from up head, under my clavicle and down my back; pain came from up head, under my clavicle and down my back; pain came from up head, under my clavicle and down my back; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the same symptoms as nurse (reporter). The nurse stated ""I got the Covid vaccine on 18Dec2020 and had soreness in my arm that was gone by the next day. On 23Dec2020, while driving home driving home, I felt severe pain in neck. I almost felt like something went up in my neck and started squeezing on a nerve. It proceeded to get bad so I took muscle relaxants. Christmas day was horrible, I couldn't lift my head off my pillow. The pain came from up head, under my clavicle and down my back. "" The outcome of events was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Back pain', 'Bone pain', 'Headache', 'Neck pain', 'Nerve compression', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 923704,,36.0,F,"intermittent fever; diarrhea; chills; nausea; This is spontaneous report from a non-contactable other health professional. An adult female patient (occupation: Nurse, not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), intramuscularly at the age of 36-year-old (age at the time of vaccination) on 28Dec2020 at single dose at left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 2 days later (30Dec2020): diarrhea, chills, nausea, intermittent fever. The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was unknown. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/30/2020,2.0,PVT,,,,,,"['Body temperature', 'Chills', 'Diarrhoea', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,OT 923705,MA,41.0,F,"slight shortness of breath all lasting over 1 week; Extreme chills; extreme fatigue and tiredness; whole body muscle aches; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received bnt162b2 (batch/lot number and expiration date not provided, not available/provided to reporter at the time of report completion), via an unspecified route of administration, at arm left, first dose on 23Dec2020 09:15, at single dose, for COVID-19 immunization. No relevant medical history. No known allergies to medications, food, or other products. There were no concomitant medications. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced extreme chills, extreme fatigue and tiredness, whole body muscle aches, slight shortness of breath all lasting over 1 week, all from 23Dec2020 16:15. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included COVID test (test type: Nasal Swab, test name: rapid test): negative, on both 27Dec2020 and 30Dec2020. The outcome of the events was not recovered. Information about Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Dyspnoea', 'Fatigue', 'Myalgia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 923706,,,F,arm soreness around injection site of vaccination; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on an unspecified date at single dose in the arm for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient's arm soreness around injection site of vaccination. Event took place after use of product. Outcome of event was unknown. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination site pain'],UNK,PFIZER\BIONTECH, 923707,CA,50.0,M,"Cough; Flu like symptoms; It hurts to walk; I have a stuffed up nose, I did not have it yesterday; Pale; I felt weak; Bones ache; Have not been feeling good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 28Dec2020 at single dose on arm for suppress the COVID-19 (COVID-19 immunization). The patient's medical history included blood pressure, stomach ulcer and psoriatic arthritis. The concomitant drug was reported as colecalciferol (VITAMIN D), potassium citrate, multivitamin, etanercept (ENBREL) at once a week, pen shot in stomach, omeprazole (PROTONIX) at once a day for stomach ulcer and blood pressure medications. The patient was a correction officer, patient work at the prisons in (state name) and were given vaccination of Pfizer on Monday and he did that on Monday and have been getting sick and it's getting worse everyday, so yesterday at work everything was fine and he went home at 8 'O' clock at night because he was getting pale, felt weak, bones ache and have not been feeling good and today he called it in because he woke up with the cough, flu like symptoms. And it's worse today than it was yesterday. Consumer stated today, bones ache was worsening of like weaker, it hurts to walk and bone ache was really, today was worse than yesterday for the bone. Today flu like symptoms was worse, today patient have more heavier cough, was coughing more today and have a stuffed up nose, I did not have it yesterday. Wanted to know if this was a side effect or is that normal with that vaccine. Start date of events was on 28Dec2020. When patient started feeling some symptoms that started getting progressively worse on 29Dec2020. Treatment included Tylenol for bone pain and hurts to walk. Lab test blood work done in Dec2020, once a month through psoriatic arthritis doctor. The outcome of events, weak, Bone pain, Cough, Flu like symptoms, was not recovered. The outcome of other events was unknown. Information on Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,UNK,VITAMIN D [COLECALCIFEROL]; ; ENBREL; PROTONIX [OMEPRAZOLE],,Medical History/Concurrent Conditions: Blood pressure (Verbatim: Blood pressure); Psoriatic arthritis (Verbatim: Psoriatic arthritis); Stomach ulcer (Verbatim: Stomach ulcer),,,"['Asthenia', 'Blood test', 'Bone pain', 'Cough', 'Feeling abnormal', 'Influenza like illness', 'Nasal congestion', 'Pain', 'Pallor']",UNK,PFIZER\BIONTECH, 923708,MI,21.0,M,"Lost sense of taste; Lost sense of smell; Whole body is sore; Rapid test came back positive for COVID; Rapid test came back positive for COVID; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) via a contactable consumer (patient). A 21-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730, expiration date: 31Mar2021), via intramuscular on 29Dec2020 07:40 at 0.3 mL, single dose on his left deltoid for covid-19 immunization. Medical history included allergic to wasp stings. There were no concomitant medications. The patient had no additional vaccines administrated on the same date and no prior vaccinations were received within 4 weeks. Caller on the line calling about the COVID Vaccine he received on 29Dec2020. The day after receiving it he woke up and had a loss of sense of smell on 30Dec2020 12:00. That afternoon he went to get tested and the rapid test came back positive for COIVD on 30Dec2020. He was now waiting on the other one, clarified to be the PCR test, the lab test. The next day he also lost his sense of taste on 31Dec2020 11:00 and his whole body feels sore on 30Dec2020 around noon. Transfer agent stated the caller needs to be transferred to Medical Information as he was scheduled to get the next shot on 19Jan2021 and he was calling to ask if he should proceed with that. It was reported that the patient works in a hospital (not an HCP). No emergency room was visited and no physician office was visited. The outcome of the event ""rapid test came back positive for covid"" was unknown, the outcome of the other events ""lost sense of smell"", ""lost sense of taste"", ""whole body is sore"" were not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Allergy to sting NOS (Allergic to wasp stings),,,"['Ageusia', 'Anosmia', 'Pain', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,OT 923709,WA,,F,"Report she had nausea 2 days after the shot; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had nausea 2 days after the shot on unknown date. The outcome of event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Nausea'],UNK,PFIZER\BIONTECH, 923710,SC,,U,"aches; chills; This is a spontaneous report from contactable nurse (patient) via a sales representative. A patient of unspecified age and gender started to receive BNT162B2 (also reported as ""Pfizer COVID Vaccine""), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was given 2nd dose of the COVID vaccine and 24 hours later, the patient had aches and chills. The outcome of the events was unknown. No follow-up attempts are possible. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Chills', 'Pain']",2,PFIZER\BIONTECH, 923711,MA,52.0,F,"10 minutes after administration, back of tongue and soft palate started feeling strange sensation with some swelling; 10 minutes after administration, back of tongue and soft palate started feeling strange sensation with some swelling; 10 minutes after administration, back of tongue and soft palate started feeling strange sensation with some swelling; Other vaccine was received on same date vaccine date 30Dec2020; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EJ1685), intramuscularly on 30Dec2020 at 12:30 PM on Right arm at single dose for COVID-19 immunization in hospital. Other vaccine was received on same date vaccine date 30Dec2020. The patient medical history included known allergies: Shellfish. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, or any other medications within two weeks of vaccination. The patient experienced 10 minutes after administration on 30Dec2020 at 12:40 PM, back of tongue and soft palate started feeling strange sensation with some swelling. After 30 minutes, the sensation eased up but the swelling stayed the same, not getting any worse. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included diphenhydramine hydrochloride (BENADRYL). The outcome of the event 'feeling strange sensation' was recovering, outcome of events 'back of tongue and soft palate swelling' was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Shellfish allergy,,,"['Feeling abnormal', 'Palatal swelling', 'Product use issue', 'Swollen tongue']",1,PFIZER\BIONTECH,OT 923712,TN,,U,"Severe headaches; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe headaches on an unspecified date. The event outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,,,UNK,,,,,,['Headache'],UNK,PFIZER\BIONTECH, 923713,CA,48.0,F,"Fever, dizziness / light headedness, servere muscle aches, vomiting, diarrhea, sore throat, like I got a servere flu",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,Omeprazole Metoprolol,,Fibromyalgia,,Iodine,"['Diarrhoea', 'Dizziness', 'Myalgia', 'Oropharyngeal pain', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 923714,TX,60.0,F,"Golf ball size swelling below the injection site. Arm is red and itchy; Golf ball size swelling below the injection site. Arm is red and itchy; Golf ball size swelling below the injection site. Arm is red and itchy; This is a spontaneous report from a contactable other-HCP (patient). This 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 28Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included pulmonary embolism and known allergies: penicillin. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), vitamin b complex (VITAMIN B), ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), tocopherol (VITAMIN E), received within 2 weeks of vaccination. Facility that the most recent COVID-19 vaccine administered was in Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 14:45, the patient experienced golf ball size swelling below the injection site. Arm was red and itchy. No treatment received for the adverse event. Outcome of the events was recovering. This report was assessed as non-serious. Information about Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PHM,BABY ASPIRIN; VITAMIN B; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; VITAMIN E [TOCOPHEROL],,Medical History/Concurrent Conditions: Penicillin allergy; Pulmonary embolism,,,"['Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site swelling']",1,PFIZER\BIONTECH,OT 923715,IN,48.0,F,"Chills/shivering, body aches, nausea, fatigue, extreme pain and tenderness at the injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,WRK,"LoEstrin, Synthroid, Zoloft",None,Thyroid cancer,,None,"['Chills', 'Fatigue', 'Injection site pain', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 923716,PA,,F,"Feels sore and little swollen; Arm soreness and feeling crummy like does not feel good; Arm soreness and feeling crummy like does not feel good; Feels sore and little swollen; This is a spontaneous report from a Pfizer-sponsored program from a contactable Nurse (patient). A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #: EK9231), on an unspecified date at single dose on arm for COVID-19 immunisation. Medical history included asthma. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), took one puff twice a day and it's 100 over 50. The patient took the Covid vaccine. Her arm was feeling sore and she feels a little crummy after the vaccine like she feel crummy like she does not feel good. She wanted to know if she could take Tylenol because of her arm soreness and feeling crummy. It feels really sore and little swollen yeah. The outcome was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,ADVAIR,,Medical History/Concurrent Conditions: Asthma,,,"['Discomfort', 'Pain', 'Pain in extremity', 'Swelling']",UNK,PFIZER\BIONTECH, 923717,NC,27.0,F,"Cervical lymphadenopathy, developing over 2 weeks; This is a spontaneous report from a contactable physician reported for herself. This 27-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on an 17Dec2020 12:45 PM on left arm at single dose (Lot # EX5730) for covid-19 immunisation. No other vaccine in four weeks. The patient experienced cervical lymphadenopathy on 23Dec2020, developing over 2 weeks. No treatments were received. Outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/23/2020,6.0,PVT,,,,,,['Lymphadenopathy'],1,PFIZER\BIONTECH,OT 923718,MD,43.0,F,"Itching; Redness; Swelling; it felt hot; This is a spontaneous report from a contactable other Nurse(patient). The 43-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration by injection in the right deltoid on 21Dec2020 at single dose to protect herself from getting COVID. Medical history included ongoing chronic sinusitis , ongoing seasonal allergy. Concomitant medication included ongoing cephalosporin for Chronic sinusitis from 29Dec2020 which was the only thing new that she has been taking, but she had taken it in the past many times, ongoing cetirizine hydrochloride(ZYRTEC) for seasonal allergies, ongoing fluticasone propionate (FLONASE) for seasonal allergies which had been taking this for years. She got her first dose of the COVID vaccine last Monday, the Monday before Christmas on 21Dec2020. Yesterday(30Dec2020), in the exact spot that she received it, she was getting itching, redness, and swelling. She read and was told that that could happen, she just thought it would be sooner rather than 9 days later. She was calling to get this reported. Otherwise, she is fine. She had been using antihistamines and cortisone cream as treatments. She had been taking cetirizine hydrochloride for years. She normally took at night, but because of her arm she took it this morning.Last night(30Dec2020) she also put ice to the are as it felt hot. Outcome of events was not recovered. Events(itching, redness, and swelling) were assessed as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/30/2020,9.0,UNK,; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLONASE [FLUTICASONE PROPIONATE],Chronic sinusitis; Seasonal allergy,,,,"['Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site swelling', 'Vaccination site warmth']",1,PFIZER\BIONTECH, 923719,FL,77.0,M,"""Tightness in lungs/chest"", stiff neck, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PUB,,,"COPD, Heart, Pacemaker, Stents",,"PCN, BRIO","['Chest discomfort', 'Headache', 'Musculoskeletal stiffness']",1,PFIZER\BIONTECH,IM 923720,VT,46.0,F,"muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; headache; Nausea; left arm numbness; left arm tingling; left hand numbness/left side of face and head numb; left hand tingling; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL1284), intramuscular on 30Dec2020 04:45 at single dose at left deltoid as Covid vaccine for coronavirus. Medical history was none. There were no concomitant medications. The patient stated that she had Covid vaccine. She had dizziness, headache, nausea, left arm hand numbness and tingling, feels very weak, left side of face and head numb, all on 30Dec2020, neck pain and feeling tired, muscle aches, eyes watering and won't stop, eyes hurt in the morning, all on 31Dec2020. Treatment was None. Headache, eyes watering and won't stop, feels very weak and tired, eyes hurt was reported as worsened. Outcome of Nausea, left arm numbness was recovering, of other events were not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Dizziness', 'Eye pain', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Lacrimation increased', 'Myalgia', 'Nausea', 'Neck pain', 'Paraesthesia']",UNK,PFIZER\BIONTECH,OT 923721,NJ,64.0,F,"a slight chill the first night; slight tenderness to arms; This is a spontaneous report from a contactable nurse reported for her identical twin sister. A 64-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included unspecified flu vaccine on 18Dec2020. The patient experienced a slight chill the first night and slight tenderness to arms on 28Dec2020 with outcome of unknown. Information about Lot/Batch number requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['Chills', 'Tenderness']",UNK,PFIZER\BIONTECH, 923722,VA,33.0,F,"1 day post vaccine, 3inx3in raised circle hive noted to right upper arm with pain and itching. increased in size over night to at least 4x4 inches..... on 1/6 early am which is 8 days past vaccination, Arm started itching again and hive noted to be about 1x1 with increasing size and itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"Prozac 20 mg, Vienva birth control. Multi vitamin, Vitamin D. Ibuprofen.",None,Endometriosis.,,"Morphine, Diluadid- anaphylactic reaction.","['Condition aggravated', 'Pain in extremity', 'Pruritus', 'Urticaria']",1,MODERNA,IM 923723,WI,57.0,F,"10 hours later severe pain in the tragus of both ears which woke me up; Headache within 5 minutes which lasted until the next day; This is Spontaneous report from a contactable Other-HCP (patient). A 57-years-old female patient (No pregnant) received first dose bnt162b2 (BNT162B2, lot: EL1284), via an unspecified route of administration on 30Dec2020 17:00 at single dose on Right arm for covid-19 immunisation. Medical history was none. Concomitant medication included celecoxib (CELEBREX), black cohosh [cimicifuga racemosa] (BLACK COHOSH [CIMICIFUGA RACEMOSA]) and multivitamins. The patient previously took erythromycin and experienced drug hypersensitivity. The patient experienced Headache within 5 minutes (30Dec2020 17:05) which lasted until the next day, then about 10 hours later (31Dec2020 03:00) severe pain in the tragus of both ears which woke her up. It felt like someone was grabbing them with pliers. Still recurs mildly from time to time. No treatment received. The events were reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,CELEBREX; BLACK COHOSH [CIMICIFUGA RACEMOSA],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Ear pain', 'Headache']",1,PFIZER\BIONTECH, 923724,,59.0,F,"made my arm really sore; fever; nervous; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number and expiration date not reported, via an unspecified route of administration from an unspecified date as single dose for COVID-19 immunization. The patient's medical history was concomitant medications were not reported. The patient stated, ""where I got my shot made my arm really sore for about three days. On the third day, I ran a low-grade fever-100F. The fever lasted 12 hrs. Now I'm fine. I was a little nervous about traveling but read that there was a side effect."" The outcome of the event was unknown. Information on lot/batch number was requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Body temperature', 'Nervousness', 'Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH, 923725,PA,53.0,F,"Approx 730 the evening of the vaccine I was resting laying down with both legs up (horizontally). I suddenly felt a ""snap"" in my left calf which led to severe muscle pain. I can barely walk. It is still painful today. About the same time I developed chills which lasted till about 1PM today. Within 10 minutes of the shot I was dizzy and nauseous (lasted about 15 min). About 20 minutes after the shot my face turned red and lasted about 5 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,"Xyzal, Jolessa, budesonide nasal spray, multivits, vit D, vit C, vit B complex, apple cider vinegar",none,none,cellulitis with Tetnus vaccine,"sulfa allergy, no food allergies. Allergies to dust mites, cats, dogs, weeds, trees.","['Chills', 'Dizziness', 'Erythema', 'Feeling abnormal', 'Myalgia', 'Nausea']",1,MODERNA,IM 923726,,,U,"I had the covid vaccine of 12/29 and I had a little bit of an allergic reaction; Well on 12/30 I had some peanut butter and within 5 minutes I had an extremely itchy palm of hand.; my palm was bright red and a little tingling; my palm was bright red and a little tingling; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient medical history included allergic to peanuts. The patient concomitant medications were not reported. Patient had the covid vaccine of 29Dec2020 and had a little bit of an allergic reaction. As a child patient was very allergic to peanuts but have out grown it as an adult. Well on 30Dec2020 patient had some peanut butter and within 5 minutes patient had an extremely itchy palm of hand. Patient immediately looked and palm was bright red and alittle tingling. Patient went and washed hand. It went completely way after about 30 minutes. Other then that feel fine. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,,,UNK,,,Medical History/Concurrent Conditions: Food allergy,,,"['Allergy to vaccine', 'Erythema', 'Paraesthesia', 'Pruritus']",UNK,PFIZER\BIONTECH, 923727,NY,30.0,M,"left sided facial muscle soreness; Arm soreness/by injection in the left arm; This is a spontaneous report from a contactable consumer (patient). The 30-year-old male patient received BNT162B2(COVID Pfizer vaccine, Batch/lot number: EK9231), via an unspecified route of administration on 31Dec2020 at single dose by injection in the left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient stated that he just got the COVID vaccine an hour ago. Within 20 minutes he developed left sided facial muscle soreness, which was the side he got the vaccine on, and arm soreness, on 31Dec2020. There was no treatment. Outcome of events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Myalgia', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 923728,,39.0,F,"My ear started to ring; My blood pressure was kind of up; Lot of anxiety; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included neuropathy. Concomitant medication included pregabalin (LYRICA) for neuropathy. The patient experienced side effects on 30Dec2020: she had the injection on 30Dec2020 and then about five minutes after like she just walked to sit down, her ear started to ring pretty significantly just like ring in both ears and she spoke with the medical professional there, the nurse was like to see her blood pressure and she did, her blood pressure was kind of up and the ear ring had continued. It never stopped. It got better. She was kind of had a lot of anxiety around this. The outcome of event ear started to ring was resolving, outcome of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,LYRICA,,Medical History/Concurrent Conditions: Neuropathy (Verbatim: Neuropathy),,,"['Anxiety', 'Blood pressure increased', 'Blood pressure measurement', 'Tinnitus']",UNK,PFIZER\BIONTECH, 923729,WA,21.0,M,2 3/4 in. by 1 3/4 in. area of redness with some swelling and slight itchiness.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PUB,none,none,none,,none that I am aware of,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA,SYR 923730,GA,43.0,U,"I am so fatigue, so tired; I have like some lower nasal congestion but it's more or like facial pressure like sinusitis; I have like some lower nasal congestion but it's more or like facial pressure like sinusitis; I have like some lower nasal congestion but it's more or like facial pressure like sinusitis; Now my head is hurting a little bit.; For more than ever I can't either keep myself up; This is a spontaneous report from a contactable consumer (patient). A 43-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension, allergy, asthmatic. Concomitant medication included amlodipine for hypertension, hydrochlorothiazide (that's water pill). On 31Dec2020, the patient experienced so fatigue, so tired, so patient had to get out of it. The patient had like some lower nasal congestion but it's more or like facial pressure like sinusitis, head was hurting a little bit, for more than ever patient can't either keep itself up. The outcome of events was unknown. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,UNK,;,,Medical History/Concurrent Conditions: Allergy (Verbatim: Allergy); Asthmatic (Verbatim: Asthmatic); Hypertension (Verbatim: Hypertension),,,"['Asthenia', 'Facial pain', 'Fatigue', 'Headache', 'Nasal congestion', 'Sinusitis']",UNK,PFIZER\BIONTECH, 923731,IL,,F,"Headache; Chills; Joint pain; My fever went up to 102.7; This is a spontaneous report from a contactable nurse. A 54-year-old female patient receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration in Left Upper arm on an unspecified date at a single dose for covid. The patient medical history was not reported. Concomitant medication included magnesium hydroxide (MILK OF MAGNESIA). The patient called in to report side effects. The patient received the vaccine at 9 am then woke up in the middle of the night with the headache and chills, joint pain, fever that went up to 102.7. Treatment included Tylenol. The nurse considered the events as related to the vaccine. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,MILK OF MAGNESIA,,,,,"['Arthralgia', 'Body temperature', 'Chills', 'Headache', 'Pyrexia']",UNK,PFIZER\BIONTECH, 923732,MI,34.0,F,"Numbness and tingling in roof of mouth, tongue, and lips; no medications given, Transferred to ED for evaluation and further monitoring",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,NKDA,,,,,"['Hypoaesthesia oral', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 923733,CA,,M,"flare of arthritis; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. Medical history included arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received Covid-19 vaccine on 30Dec2020, then he had flare of arthritis in Dec2020 (have this before having the vaccine). Asked if take steroids will affect the Covid-19 vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: Arthritis,,,['Arthritis'],UNK,PFIZER\BIONTECH, 923734,,,U,"Arm little bit swollen, the arm that I got the shot on; My body feels like tired; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration (arm), on an unspecified date in Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, ""I took the COVID vaccine yesterday and my arm has a little bit swollen, the arm that I got the shot on. And my body is just like you know when you are, it just feels like my body feels like tired. I was wondering can I take Tylenol or no? I just have one more question, do you think I should be going to work today?"" Outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,,,UNK,,,,,,"['Fatigue', 'Vaccination site swelling']",UNK,PFIZER\BIONTECH, 923735,CA,59.0,F,"It was like mild lower back pain like on the lower left part of my back on top of my buttocks; Pain just seems to be getting worse; Dizziness/Lightheaded; Headache; This is a spontaneous report from a contactable healthcare professional. A 59-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Covid 19 Vaccine; lot number: EL3246; expiration date: unknown), via an unspecified route of administration left upper arm on 30Dec2020 11:30 AM at a single dose for Covid-19 vaccination. The patient has no medical history and concomitant medications. The patient reported that she got her first dose of Pfizer vaccine (COVID-19 Vaccine) yesterday (30Dec2020) and today (31Dec2020), she was having at first it was like mild lower back pain like on the lower left part of her back, on top of her buttocks and now it's getting worse. The patient inquired if it was like a side effect. The patient further stated that yesterday (30Dec2020), she had a side effects like the dizziness, lightheaded and the headache and that went away after she took Tylenol (treatment) but then today this pain just seems to be getting worse. The paracetamol (TYLENOL) was given to her at hospital yesterday for the headache and the dizziness. She hasn't taken anything today because she was not sure if it is okay for her to take Ibuprofen which is what she would prefer to take. She received her COVID-19 Vaccine at a hospital. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Back pain', 'Dizziness', 'Headache']",1,PFIZER\BIONTECH, 923736,FL,57.0,M,"One day after Moderna Covid 19 vaccine eua my wife noticed a blister on my forehead. I initially dismissed it as one of those things. Over the next couple of days the blisters spread in a line on my forehead. Soon after the blisters were around my ear. I went to an urgent care and was diagnosed with shingles. Currently the blisters on my forehead are receding, but the blisters behind my ear are still painful. I received valtrex for the treatment of shingles",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,Lisinopril lexapro allopuronol trazadone multivitamin,no,htn depression gout sleep disturbance,,no,"['Blister', 'Herpes zoster']",1,MODERNA,IM 923737,,,U,"headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK5730), via an unspecified route of administration on 26Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Covid vaccine on 26Dec2020. The patient's daughter has like a fever yesterday with headache. The patient thinks his/her daughter has Covid and was just tested yesterday, so they still do not have results. Today (01Jan2021) the patient woke up with a headache, a different headache than which he/she usually has, but he/she does not have fever. The patient is not sure if she should report this, but he/she was told to report anything to the Pfizer company. The patient asked if he/she should be tested for Covid as well. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,01/01/2021,6.0,UNK,,,,,,['Headache'],UNK,PFIZER\BIONTECH, 923738,VA,33.0,F,"she did not felt great/ felt the worst that she had been feeling; temperature was like 100.3/fever; chills; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 33-year-old female patient received bnt162b2 (BNT162B2 also reported as Covid19 Vaccine a Pfizer, lot EH9899, expiry date not reported), via an unspecified route of administration on 29Dec2020, single dose, for Covid-19 immunisation (prevention of Covid-19). Medical history was none. Concomitant medication included PRENATAL VITAMINS. The patient informed she did not felt great the day (29Dec2020) or 2 that when she got the vaccine. She felt the worst that she had been feeling. Her temperature was like 100.3/fever and had chills (29Dec2020). No treatment was taken. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,UNK,PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'Chills', 'Malaise', 'Pyrexia']",UNK,PFIZER\BIONTECH, 923739,CA,61.0,F,"Shingles; This is a spontaneous report from a contactable nurse reporting for herself. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number PAA156571) via an unspecified route of administration, on 20Dec2020, single dose for COVID-19 immunization. Relevant medical history included hypercholesterolemia. Concomitant medications were not reported. The patient took unspecified medication for hypercholesterolemia however the patient stopped taking it for a month or two already. The patient got the first Pfizer vaccine shot on work (clinic) on 20Dec2020. On 28Dec2020, the patient developed shingles which is now being treated. The patient does not know if this is because of that or a part of it. The patient never had Shingles before. Outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/28/2020,8.0,OTH,,,Medical History/Concurrent Conditions: Hypercholesterolemia,,,['Herpes zoster'],UNK,PFIZER\BIONTECH, 923740,IL,54.0,M,High blood pressure. BP went from 146/84 before immunization to 185/90 post immunization. The day after BP is 193/106 and requires medical evaluation.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PUB,none,,Bronchitis,,,['Hypertension'],1,MODERNA,SYR 923741,,,F,"headache; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine the day prior to the report and she got a headache. The event outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,,,UNK,,,,,,['Headache'],UNK,PFIZER\BIONTECH, 923742,HI,58.0,F,"scratchy throat; tired; headache; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), intramuscular in 24Dec2020 11:30 at a single dose in the left arm as Covid vaccine. The patient had no medical history. The patient no known allergies. Concomitant medication included propranolol (within the two weeks). The patient had no prior COVID vaccination and was not tested for COVID post vaccination. On an unknown date, the patient experienced scratchy throat, tired, and headache. No treatments received in response to the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The outcome of the events scratchy throat, tired, and headache was recovered with lasting effects. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Fatigue', 'Headache', 'Throat irritation']",1,PFIZER\BIONTECH,OT 923743,TX,32.0,F,I had a miscarriage on 01/01/2021 Estimated date of Delivery 09/7/ 2021,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/01/2021,6.0,PVT,Prenatal Vitamin,None,None,,None,"['Abortion spontaneous', 'Human chorionic gonadotropin negative', 'Laboratory test', 'Progesterone normal']",1,MODERNA,IM 923744,,30.0,F,"severely dehydrated; sweaty; dizzy; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration from 03Jan2021 14:30 to 03Jan2021 14:30 as single dose for COVID-19 immunization. Medical history included allergies to latex, psoriatic arthritis, asthma, migraines and COVID19 prior vaccination. The patient's concomitant medications were not reported. The patient previously took Vicodin, Codeine, Imitrex and experienced allergies. On 03Jan2021 15:00, the patient got severely dehydrated, sweaty, dizzy. The outcome of the events was recovered. The patient does not received treatment for the events. No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Asthma; COVID-19 (If covid prior vaccination: Yes); Latex allergy (known allergies: latex); Migraine (Migraines); Psoriatic arthritis,,,"['Dehydration', 'Dizziness', 'Hyperhidrosis']",UNK,PFIZER\BIONTECH, 923745,WI,43.0,M,"Soreness in injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration (arm left) on 31Dec2020 (10:00) to 31Dec2020 10:00 at single dose for Covid-19 immunization. The patient's medical history included GERD (gastroesophageal reflux disease). Concomitant medications were not reported. The patient has no allergy to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced soreness in injection site on 31Dec2020 17:00 with outcome of recovering. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PUB,,,Medical History/Concurrent Conditions: GERD,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 923747,FL,37.0,M,"Pt received vaccine at 11:45 and was sitting in observation for 8 minutes when he stated he felt like he was getting really warm. Pt was put in wheelchair and taken to a room to lay down. Vital signs BP 139/88, P 68, R 20 SP02 98%. Pt face was flush. No signs of SOB or any other symptoms. After 10 minutes patient stated the ""hot feeling"" was going away. We monitored him for additional 30 minutes and patient was able to sit up without any difficulties or changes in the way he felt. Patient was released to his command with no limitations.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,MIL,Protein shakes in the morning,None listed,None listed,,PCN as child,"['Feeling hot', 'Flushing']",1,PFIZER\BIONTECH,IM 923748,NH,40.0,F,lymphatic reaction in left axillary. Hard painful lymph.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PVT,none,none,none,,none,['Lymphadenopathy'],1,MODERNA,IM 923749,CO,22.0,F,"Fever of 101.7 Fahrenheit, body aches, fatigue, nausea, headache, loss of appetite",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,"Birth control pill, over the counter allergy med",None,None,,None,"['Decreased appetite', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 923750,NY,28.0,F,Right arm soreness,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,OTH,"Meloxicam, larin",,,,,['Pain in extremity'],1,MODERNA,SYR 923752,MA,52.0,F,"Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, nausea, diarrhea, chest tightness, dry cough",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/21/2020,1.0,WRK,"Magnesium, Vitamin D, Zyrtec",None,"Fibromyalgia, Migraine",Fever and chills with Shingrix vaccine,NKA,"['Ageusia', 'Chest discomfort', 'Chills', 'Cough', 'Diarrhoea', 'Headache', 'Malaise', 'Nausea', 'Night sweats', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'Rhinorrhoea', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 923753,MN,29.0,M,"pale, clammy, warm, low blood pressure treatment - put client into Trendelenburg position, gave water and snack, took vitals, monitored for extra 20 minutes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,,,,fainted,,"['Cold sweat', 'Feeling hot', 'Hypotension', 'Pallor']",1,MODERNA,IM 923755,GA,48.0,F,"Headache, muscle aches, joint pain, chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,UNK,"CoQ10, MegaFoods Blood Builder, Krill Oil, Oregon Grape Seed Extract, Citocholine, Mushroom supplement for immunity, Curcumin, Green Vibrance",None,Anemia,,NKA,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia']",1,PFIZER\BIONTECH,IM 923756,RI,23.0,F,"8:05am-Patient received Covid vaccine and while being monitored c/o upper lip being numb, no other c/o voiced, no nonverbal cues noted at present time. 8:22am- Self medicated with Benadryl 25mg; tolerated without difficulty. 8:28am-Patient c/o throat tingling and verbalized having history of angio8:05am-Patient received Covid vaccine and while being monitored c/o upper lip being numb, no other c/o voiced, no nonverbal cues noted at present time. 8:22am- Self medicated with Benadryl 25mg; tolerated without difficulty. 8:28am-Patient c/o throat tingling and verbalized having history of angioedema; noted anxious, cough present, upon further evaluation noted facial swelling, top lip remains numb; patient assisted to emergency room per staff on duty; upon leaving clinic patient continued to cry for her mom; required reassurance regarding going to emergency department.edema; noted anxious, cough present, upon further evaluation noted facial swelling, top lip remains numb; patient assisted to emergency room per staff on duty; upon leaving clinic patient continued to cry for her mom; required reassurance regarding going to emergency department.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,,,Hashimoto's Thyroiditis; Asthma,,"Erythromycin, Pseudoephedrine","['Anxiety', 'Cough', 'Hypoaesthesia oral', 'Oedema', 'Pharyngeal paraesthesia', 'Swelling face', 'Vital signs measurement']",2,PFIZER\BIONTECH,IM 923757,WV,33.0,F,Arm was sore for 48 hours post injection. Ibuprofen was used for treatment,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,Calcium,None,None,sore arm,None,['Pain in extremity'],1,PFIZER\BIONTECH,IM 923758,PA,42.0,M,"Moderna COVID-19 Vaccine EUA Severe pain in injection site. Fever of 102.4, weak, lethargic, chills, achy all over.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PUB,Montelukast Sodium Tab 10mg Sertraline HCL TAB 50mg Topiramate 50mg Certirizine Hydrochloride 10mg,,Migraine,,,"['Asthenia', 'Chills', 'Injection site pain', 'Lethargy', 'Pain', 'Pyrexia']",1,MODERNA,IM 923759,SC,87.0,F,"Vaccinated on Wednesday, 12/30/2020 about 1:30PM. The next evening, patient's arm started to swell and become hot and started to itch. She had a fever as well. She stated this continued until 1/5/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Tylenol, Biotin, Melatonin, Probiotic, Pepcid, Viactiv (calcium), CBD oil",Had COVID-19 during holidays,Arthritis and sciatica,,Sulfa Drugs,"['Peripheral swelling', 'Pruritus', 'Pyrexia', 'Skin warm']",1,MODERNA,IM 923760,NY,37.0,M,"Pt rec'd vaccine. ~1 hour after, pt began noticing redness and itching to R arm, then became more diffuse, to chest and L arm. Redness was nonblanchable. Pt returned to clinic and 50mg IM benadryl was given by supervisor at ~1400. Now (~1420), redness has almost completely resolved. No SOB, chest tightness, wheezing.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,clonazepam - 1mg po nightly PRN seroquel 75mg po nightly PRN,none,asthma,,bee stings - swelling/itching,"['Erythema', 'Pruritus']",1,PFIZER\BIONTECH,IM 923761,PA,38.0,F,"After the initial, typical, local reaction resolved on Day +3 post-vaccine, I had 4 days with no adverse effects at all. On Day + 7 (1/5/2021) I woke at 6:00am with my injection site incredibly itchy, but no visible rash or swelling. Within 2 hours, splotchy rash was overlying the injection site. Gradually throughout the day, site became confluently red and began to swell. Itching continued pretty intensely. Swelling progressed until it was visible from across the room and skin changed texture in the area and feels almost like a thick, waxy, orange peel like texture. No pain. Itching resolved with 1 dose of zyrtec. Did not return. Redness and swelling persists. Swelling seems to wax and wane.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,UNK,,,,,,"['Dry skin', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Rash macular']",UNK,MODERNA,IM 923762,,37.0,F,"MINUTES AFTER VACCINE WAS ADMINISTERED PATIENT FELT DIZZY THEN COLD FLUSHING FEELING FROM FEET TO HEART AND THEN THAT STOPPED AND TINGLING FEELING THROUGHOUT BODY AND THEN VERY WARM, AND FAINT FEELING. PATIENT DID NOT FAINT. PATIENT DID VOMIT ONCE. PATIENT HAD NOT EATEN BEFORE VACCINATION WAS ADMINISTERED. 1255 VITALS: BP: 126/91 P:100 SAO2 1303 VITALS: BP: 116/99 P: 96 SA02: 100% PATIENT STATES THEY ARE FEELING BETTER. GIVEN JUICE AND BANANA. 1312 VITALS: BP: 128/87 P: 74 SA02: 100% PATIENTS COLOR HAS RETURNED TO NORMAL. STATES THEY ARE FEELING MUCH BETTER. ABLE TO STAND AND WALK WITHOUT DIZZINESS. PATIENT STATED THAT THEY DID NOT FEEL THEY NEEDED ANY FURTHER TREATMENT OR CARE. PATIENT LEFT WITH HER WORKMATE.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Dizziness', 'Feeling of body temperature change', 'Flushing', 'Paraesthesia', 'Skin discolouration', 'Vomiting']",1,PFIZER\BIONTECH,IM 923763,WI,26.0,F,"Fever of 100.3, headache, chills, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,WRK,None,None,None,,None,"['Chills', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 923764,PA,39.0,F,Patient woke on 1/01/2021 with headache; swelling of left-side of neck; swelling of tongue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/02/2021,3.0,PVT,,,,,,"['Headache', 'Swelling', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 923765,TN,29.0,F,"Lo grade fever, body aches, fatigue, pain at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,"thiamine, biotin",urinary tract infection,none,,none,"['Fatigue', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 923766,NY,26.0,F,"Went to the ER on the 31st, my face swelled and chest was covered in hives. Lips swelled. I would get nauseated and I felt like there was acid in my stomach. I also had a headache. I have been taking Zyrtec, Benadryl as needed.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,ADDERALL,,"ADHD, Lyme disease.",,Latex. benzol peroxide,"['Gastric disorder', 'Headache', 'Laboratory test', 'Lip swelling', 'Nausea', 'Swelling face', 'Urticaria']",UNK,PFIZER\BIONTECH, 923767,MA,58.0,F,Employee stated she felt dizzy shortly after receiving vaccine. Assessed by RN and EMT's and rested for 30 minutes then went home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,PRN Albuterol inhaler,Asthma flare up last week Negative COVID test,Asthma,,Latex Peach Banana Avocado,"['Dizziness', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 923768,RI,23.0,F,"Dose 1 administered on 12/28/2020 Fatigue and body aches on 12/29/2020 morning, resolved by afternoon Tender left axillary lymphadenopathy 01/03/2021-present Swelling, warmth, itchiness, soreness at injection site on 01/04/2021-01/06/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,UNK,Zyrtec,None,None,,None,"['Fatigue', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Lymphadenopathy', 'Pain', 'SARS-CoV-2 test']",1,MODERNA,IM 923770,CO,42.0,F,"About 1 week after receiving the vaccine I noticed my right arm itching, it took me a while to realize why. Once I looked at my arm in a mirror I saw that it was swollen, red & itchy. At the time the redness was about the side of a 1/2 dollar. The last few days I have noticed that my arm is itchy, red, swollen & now feels like a rash in the same location but the redness is about the size of a baseball.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PVT,"Dulaglutide, Metformin, Amlodipine, Losartan, Sertraline, Methenamine Hippurate",,"Type 2 Diabetes, Frequent UTI, Hypothyroidism, GERD, NAFLD, Mixed hyperlipidemia",,"Ciprofloxacin Hcl, Penicillin, Sufa, Cefaclor, Erythromycin, Levofloxacin, Sulfonylureas","['Erythema', 'Pain in extremity', 'Peripheral swelling', 'Pruritus']",1,MODERNA,SYR 923771,MA,42.0,F,"Presented with pain at injection site for days1-4 followed by flat, blanchable welt on left deltoid that was warm to touch and erythemic, approximately 1.5?x2.5? in size, on day 10. Afrebile.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/06/2021,9.0,WRK,,,,,"Ceclor, amoxicillin, zithromax","['Injection site pain', 'Injection site warmth', 'Pallor', 'Urticaria']",1,MODERNA,IM 923772,NY,23.0,F,"Shortness of breath, hives, and itching. Took benadryl, famotidine, Xyzal at time of reaction. Also 4 puffs on ventolin. Symptoms slowly improved over 4 hours. Epiniphrine not administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Xyzal, singulair, Topomax, Paroxetine, Epipen as needed, ventolin as needed, benadryl as needed",no,chronic migraine; allergies,,Shell fish allergy (anaphylaxis); Tree nut (anaphylaxis); bee stings (anaphyalxis),"['Dyspnoea', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 923773,OH,44.0,F,"Left arm swelled, red, itchy, tender 1 week after injection. Only sore the day or 2 after injection snd then the symptoms started one week to the day of the shot",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PUB,"Vitamin c, D, birth control",No,No,Redness after flu shot in 2019 same arm. 42,No,"['Erythema', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Tenderness']",UNK,MODERNA,SYR 923774,FL,62.0,F,Headache for 7 days then resolved,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,Metoprolol,,HTN,,None,['Headache'],1,PFIZER\BIONTECH,IM 923775,MD,45.0,F,Significant left subclavicular lymphadenopathy; single area measured 10 mm on ultrasound.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/01/2021,9.0,PVT,HZTZ 25 mg Zyrtec prn,NONE,Hypertension dx 2016 Acute macular neuroretinopathy dx 2016 Seasonal allergies,,NKDA,"['Lymphadenopathy', 'Ultrasound scan']",1,PFIZER\BIONTECH,IM 923776,VA,36.0,F,"12/26/2020: Nausea, vomiting, diarrhea for 24 hours 12/29/2020: shortness of breath, chest tightness for 36 hours. Went to ER. COVID and flu tests done. Both negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/26/2020,4.0,PVT,"Lexapro, oral contraceptive",None,None,,None,"['Chest X-ray normal', 'Chest discomfort', 'Computerised tomogram normal', 'Diarrhoea', 'Dyspnoea', 'Fibrin D dimer increased', 'Influenza virus test negative', 'Nausea', 'SARS-CoV-2 test negative', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 923777,NE,53.0,F,"Injection area is red, swollen, warm to touch",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/05/2021,8.0,PVT,"Lisinopril 20mg, Citalopram 40mg, Simvastatin 40mg",none,none,,none,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 923778,,54.0,F,"patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joint pain and had to take analgesics. Pain radiated through her upper body and at times was shooting. she was unable to perform ADLs. She then developed an itchy rash all over her upper body as well as a headache and swollen lymph nodes. Covid test was negative, CRP was 3.6 and sed rate was 25. all other labsl WNL, symptoms resolved after 5 days",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/30/2020,12.0,UNK,,,,,,"['Arthralgia', 'C-reactive protein normal', 'Headache', 'Loss of personal independence in daily activities', 'Lymphadenopathy', 'Pain', 'Pain in extremity', 'Rash', 'Rash pruritic', 'Red blood cell sedimentation rate normal', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 923779,TX,26.0,F,"It was noted during injection a tremendous amount of pain/stinging/burning that lasted a few minutes. About 20 minutes post injection, numbness/tingling noted in pinky/5th finger radiating down palm to wrist on same arm as injection as well as dizziness. Notified observation RNs and moved to a separate room. Mildly elevated BP but normal HR noted. No rash/hives/difficulty breathing. Numbness and tingling would migrate - most often to thumb but sometimes up entire arm. Released 1 hour after injection after no life threatening signs noted. Visited PCP the next day (1/6) at 10:15. Professional opinion that it is due to swelling from injection - now noticeable area of swelling around injection site. Recommended ice and NSAIDs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,Venous malformation in arm (opposite arm vaccine was given in),Flu shot in 2016 or 2017; 22 or 23 years old; hives/rash to face that would come and go for months; unsure of brand name but w,"Sulfa, codeine, shellfish, egg* *Had reaction (rash) 4 years ago to flu vaccine, was not egg free. Have received egg free since without issue.","['Blood pressure increased', 'Burning sensation', 'Dizziness', 'Hypoaesthesia', 'Injection site swelling', 'Pain', 'Pain in extremity', 'Paraesthesia']",1,MODERNA,IM 923780,IA,39.0,M,"Pt's only real complaint: mild lightheadedness/dizziness. No CP, SOB, cough, throat swelling, difficulty swallowing, stridor, syncope, neuro deficits, HA, fever, chills, nausea, vomiting or pain of any kind. Patient was evaluated and workup was done in ED: EKG, CXR, labs. Patient was observed for ~2 hours after which his symptoms were totally gone and patient was sent home with normal vitals and without complaints of any kind.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,none,none,none,,none,"['Chest X-ray', 'Dizziness', 'Electrocardiogram', 'Laboratory test']",1,MODERNA,IM 923781,TX,23.0,F,"23 hours after vaccine, had facial and neck swelling and tongue swelling. Had difficulty swallowing. Took Benadryl 50 mg. Happened again after 2 hours (25 hours after vaccine), took another Benadryl 50 mg. Then happened one more time about 36 hours after vaccine, had to use epipen, took Benadryl and Claritin as well. Symptoms improved and throat opened.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PUB,Gabapentin Lexapro Benadryl,,,,"Amoxicillin, latex","['Dysphagia', 'Swelling', 'Swelling face', 'Swollen tongue']",1,MODERNA,SYR 923782,UT,54.0,F,9 days after getting first dose of covid vaccine I woke up with my arm having a big red circle where the injection has been administered on 12/28/2020. The sight felt a little warm . Didn't hurt.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,OTH,"Lipitor, singular, chronium pickolinate, berberine, coq10 tumeric omperazole blood pressure med. Allegra d or allegra asthmanex, albuterol",,"high cholesterol/ high blood pressure controlled by meds, asthma sleep apnea gerd",,CIPRO,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,SYR 923783,NY,27.0,F,"I experienced swelling in my face and lips, my chest became covered in hives. I was nauseated and felt like their was acid in my stomach (burning sensation). I had a headache. Was in the ED 12/31/20. Symptoms continue to happen at random.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,WRK,ADDERALL,,"ADHD, Lyme disease.",,Latex. benzol peroxide,"['Blood test', 'Dyspepsia', 'Headache', 'Lip swelling', 'Nausea', 'Swelling face', 'Urticaria']",1,PFIZER\BIONTECH,IM 923784,RI,23.0,F,"8:05am-Patient received Covid vaccine and while being monitored c/o upper lip being numb, no other c/o voiced, no nonverbal cues noted at present time. 8:22am- Self medicated with Benadryl 25mg; tolerated without difficulty. 8:28am-Patient c/o throat tingling and verbalized having history of angioedema; noted anxious, cough present, upon further evaluation noted facial swelling, top lip remains numb; patient assisted to emergency room per staff on duty; upon leaving clinic patient continued to cry for her mom; required reassurance regarding going to emergency department.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,"Albuterol, citalopram, Junel, Spironolactone, Fexofenadine",,"Hashimoto's Thyroiditis, Asthma, PCOS",,"Erythromycin, Pseudoephedrine","['Anxiety', 'Cough', 'Hypoaesthesia oral', 'Pharyngeal paraesthesia', 'Swelling face']",2,PFIZER\BIONTECH,IM 923785,KY,32.0,M,"3 days after shot, excruciating quad pain, lower leg weakness, inability to stand",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/24/2020,3.0,PVT,"GNC daily vitamin, flomax, preworkout AM non-stimulant",Quadrivalent flu vaccine 12/5,Asthma,,None,"['Antineutrophil cytoplasmic antibody negative', 'Antinuclear antibody', 'Blood creatine phosphokinase', 'Blood heavy metal test', 'Blood magnesium', 'Dysstasia', 'Electromyogram', 'Full blood count', 'Inappropriate schedule of product administration', 'Laboratory test', 'Lumbar puncture', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging spinal', 'Metabolic function test', 'Muscular weakness', 'Myalgia', 'Red blood cell sedimentation rate', 'Vitamin B6']",1,PFIZER\BIONTECH,IM 923786,IL,49.0,M,"Chills, Body Aches, Fever of 101/102 for 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,None,None,Chronic Fatigue & head pains (headaches). I was diagnosed with Covid 19 in March 2020 and was hospitalized for 13 days and home on recovery for almost 5 months. Ever since the Covid event I have not been the same in regards to the areas noted.,,None,"['Chills', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 923787,,38.0,F,"Felt flushed, at one point felt faint, anxious, heart racing. BP 134/90 HR 80 @ 1125. Reported chest tightness and anxious a few minutes later. BP 150/108 HR 80 @ 1141. Assisted to Emergency Department across the street.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Anxiety', 'Blood pressure increased', 'Chest discomfort', 'Dizziness', 'Flushing', 'Palpitations']",1,MODERNA,IM 923788,MA,52.0,M,"Employee became diaphoretic, stated he felt his heart was racing, and that he was very anxious. Stated he has history of fear of needles. He also does extreme exercise program. Evaluated by EMT's BP 152/97, HR 56, SpO2 100% After 15 extra minutes observation employee stated he felt fine to go to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,Lipitor,Possible strep throat 1 month ago,Hyperlipidemia,,NKA,"['Anxiety', 'Hyperhidrosis', 'Palpitations']",1,PFIZER\BIONTECH,IM 923789,NY,23.0,F,"Within 24 minutes of vaccine, developed shortness of breath, hives, and itching. This was self treated with diphenhydramine, famotidine, and albuterol. EpiPen was not utilized. Patient did speak with allergist. Slowly recovered over next 4 hours until full recover.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Xyar, Ventolin, paroxetine, Singulair, benadryl, Toprol",none,Chronic allergies,,"Shell fish, bee stings, tree nuts (all anaphylaxis)","['Dyspnoea', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 923790,MD,57.0,M,Vaccinator noticed increased bleeding after injection and beginning of small area of blueish swelling approximately 2cm in diameter at the injection site. Pressure was applied by vaccinator and bleeding was quickly controlled. Injection site began bleeding minimally again during 15 min. observation period and pressure and ice were briefly applied until bleeding was controlled again. No other complaints of pain or reactions to vaccine apparent. Patient remains at site as he is working at the site as a county employee.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,UNKNOWN,NONE,UNKNOWN,,NKA,"['Injection site haemorrhage', 'Injection site swelling']",1,MODERNA,IM 923791,TN,80.0,F,"12/30/2020 around 2:00 nausea, vomitting, diarrhea, and chills started. Insomnia x3 days. Patient states she felt ""wired and worked up"". Noises made her anxious. Patient states ""everything smelled bad"". Patient had hallucinations seeing the devil and satanic thoughts 12/31/2020 to 1/4/2021 when patient finally fell asleep. 1/5/21 patient woke up with a headache and took ibuprofen and used a heating pad with relief. Patient took melatonin 1/5/21 before bed to go to sleep. Diarrhea stopped 12/31/20. Nausea stopped 1/5/21.Vomitting stopped 12/31/2020. Chills stopped 1/5/21. Patient has been eating bananas and chicken noodle soup and drinking sweet tea. Patient not as nervous 1/6/21 when she woke up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,"Theophylline, Acyclovir, Gabapentin, Sertraline HCL, Lorazepam, Azithromycin, Famotidine , Zinc, Vitamin C",None,"Legally blind, lung cancer in remission in 5 years, colon cancer in remission for 4 years, diverticulosis, COPD, emphysema",,None,"['Anxiety', 'Blood test', 'Chills', 'Diarrhoea', 'Hallucination, visual', 'Headache', 'Insomnia', 'Nausea', 'Parosmia', 'Thinking abnormal', 'Urine analysis', 'Vomiting']",1,MODERNA,IM 923792,IN,48.0,F,"Received shot Sunday evening, sore arm as expected thru Monday. Tuesday evening, blood pressure spiked became angry and exhausted and had to lie down. Reported to Dr on Wednesday morning that left arm crease near elbow painful and pulsating with heavy beats and not feeling too great. No where open to monitor BP bc of COVID-19, dr advised purchasing BP monitor or going to ED of hospital for BP check.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/05/2021,2.0,OTH,None,None,Prediabetes,,None,"['Anger', 'Blood pressure increased', 'Fatigue', 'Pain in extremity']",1,MODERNA,SYR 923793,MD,38.0,F,"about 9 cm circumference circle around injection site that is very red, hot, swollen with intermitten itchiness and aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,OTH,Organic collagen--Orgain brand Keratin Vitamin C Ashwagandha Astaxanthin Last 4 are my daily vitamins,,lactose intolerant,,Grass and Amoxicillin,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 923794,LA,61.0,F,Moderna Covid-19 vaccination : pain at injection site with swelling beginning 11 hours after injection. could not find treatment online. used Motrin 600 mg with lidocaine patch over injection site. Feeling of generalized tiredness after night of restless sleep. 3 brief incidents of dizziness within 2 hours of injection that resolved rapidly with no harmful affects.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,protonix zocor coreg lasix asa valsartan vit d vit b magnesium calcium tumeric coQ10 mobic,none,"HTN, Hyperlipidemia, Chronic back pain. obesity",,nkda,"['Dizziness', 'Fatigue', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 923795,IL,50.0,F,"Vaccinated on 01/04/21, around 1:30pm, left arm on 01/05/21,around 4am woke up with headache, sore throat, tingling and numbnes in my left arm and temp 99.1 By 6am, symptoms getting worse: temp 100.1, nausea, diarrhea, severe body ache (10/10) ,severe headache(10/10) and weakness, left arm is tingling more I suspected I may have another covid infection, because all these symptoms I had back in August 2020, when I had covid infection. Husband took me to work to get tested- negative for covid and flu on 01/05/21, Today, 01/06/21, still bed resting, but feeling better . No nausea, no left arm problems, body and head ache pain level 7/10.no appetite, but drinking well, no change in taste or smell. Given severity of the symptoms, I'm definitely not taking second shot. I never had bad reactions to vaccines, side effects are anticipated, but I would clasify my case as adverse reaction, like experiencing covid infection all over again with shorted duration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,"Aspirin 81 mg, multivitamins",Heart palpitations,"Arthritis, enlarged liver, kidney cysts",,Nka,"['Adverse reaction', 'Asthenia', 'Body temperature increased', 'Decreased appetite', 'Diarrhoea', 'Headache', 'Hypoaesthesia', 'Influenza virus test negative', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Paraesthesia', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 923796,VA,23.0,F,Body aches and chills developed at 8:00pm on 1/5/2021 Fever developed at 1:00am on 1/6/2021. Subsided after taking ibuprofen. Dizziness and shortness of breath developed at 3:00am on 1/6/2021. Subsided after sleep. Major headache developed at 8:00am on 1/6/2021. Subsided after taking ibuprofen.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,UNK,,,,,,"['Chills', 'Dizziness', 'Dyspnoea', 'Headache', 'Pain', 'Pyrexia']",UNK,MODERNA, 923797,CA,58.0,M,4 days after receiving my vaccine I experienced a painful sore throat. Examination of my oropharynx reveals a solitary 1mm pustule with surrounding erythema on the posteriolateral edge of the hard palate. I have not experienced any fever or URI symptoms. It is on the same side as my vaccine. I am not sure if it is relevant but I reached out to my Infectious Disease colleague and he recommended I report this to you ( I am a Dermatologist). The lesion is still present today 36 hours later without any new lesions or progression. I do not have any history of herpes or aphthous ulcers and have never had a lesion on this part of my hard palate before.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,PVT,none,none,none,,none,"['Erythema', 'Oral pustule', 'Oropharyngeal pain', 'Pain']",1,MODERNA,IM 923798,CA,37.0,F,During administration the needle came loose from the syringe and the vaccine was expelled to the floor and patients arm. Determined that no vaccine was given and dose was repeated,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Exposure via skin contact', 'Needle issue']",1,MODERNA,IM 923799,FL,32.0,F,"Headache, Nausea, Myalgias, Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,"Lexapro, Oscal",,Depression,,"Erythromycin, PCN, Ceclor","['Fatigue', 'Headache', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,IM 923800,IN,28.0,M,Nausea about 8 hours post injection that subsided after an hour or so,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,None,None,Asthma,,None,['Nausea'],1,MODERNA,IM 923801,TX,41.0,F,"Headache. Started about two hours after vaccine. Has not subsided in 24hrs I took Tylenol 500ml two tablets, twice and today I took Aleve two tablets My left deltoid is warm & inflamed started 1/5/21 sometime in the evening",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,None,None,None,,Banana,"['Headache', 'Inflammation', 'Skin warm']",1,MODERNA,IM 923802,WA,41.0,F,"first dose of Moderna COVID vaccine. within a five minutes, had tachycardia, relative hypertensive syndrome. no wheezing or hives or itching. no anaphalaxis symptoms. Patient was observed and discharged to home. doing well. In an attempt to determine mechanism of the reaction we are ordering serum and urine catacholamines and serotonin studies results are pending. we have seen at least three others with a similar hyperdynamic tachycardia with relative hypertension immediately following the first dose of Moderna COVID vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,Prenatal MV- (PRENATAL 1 PO) Midodirine 5 mg PRN,None,none,,Sulfa Hives. Prochlorperzaine edisylate Stroke Like sx,"['Blood catecholamines', 'Catecholamines urine', 'Histamine level', 'Hypertension', 'Serum serotonin', 'Tachycardia', 'Tryptase']",1,MODERNA,IM 923803,CA,24.0,F,"Started getting a localized allergic reaction on the Left arm near the injection site. Arm became red, swollen, and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PUB,Sprintec-Birth Control,None,None,,None,"['Erythema', 'Injection site hypersensitivity', 'Local reaction', 'Peripheral swelling', 'Pruritus']",1,MODERNA,IM 923804,WA,33.0,F,"Itching to legs, torso, and arms that is persisting at time of report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"lamictal, levothyroxine, liothyronine, propranolol",None,"hypothyroidism, depression",,codeine - vomiting,['Pruritus'],1,PFIZER\BIONTECH,IM 923805,CT,72.0,F,"Received the Moderna COVID-19 vaccine 1/6/2021 at approximately 11 AM. Pt stated she does not have any history of allergy or anaphylaxis. Pt reported about 5 minutes after vaccine administration a runny nose. Pt reported she did not have a runny nose prior to administration of the vaccine. Pt notes a history of nasal problems. Pt denies difficulty swallowing, swelling of airway, difficulty breathing, itching, rash, flushing, swelling of lips, face, throat, or eyes, sensation of throat closing, change in voice, wheeze, cough, n/v/d, abd pain, dizziness, weakness. Pt confirmed she felt well other than her runny nose. Pt was observed in our observation area for 45 minutes with no progression of symptoms. Epinephrine not administered. RN consulted with medical advisor Dr. over the phone as he was off site. EMS on site. VS done by paramedic patient signed refusal with paramedic as she did not want to go to the ED. Pt was advised by RN about delayed anaphylaxis, to continue to monitor her symptoms, call 911 if additional symptoms arise. Pt declined recommendation to go the ED. Advised pt to call her PCP asap for further guidance. Advised pt there is a local urgent care she should be checked out in if she cannot get in with her PCP today. Pt verbalized understanding and agrees to the POC. 2:26 PM RN called patient to check on her and obtain additional information for VAERS form. Pt reports she is feeling well, no other symptoms developed. Pt called her doctor and is waiting for a call back.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,"Synthroid 112 mg, water pill, blood pressure medication",None,"High blood pressure, does not have a thyroid",,None,['Rhinorrhoea'],1,MODERNA,IM 923806,ND,53.0,F,"Fatigue and headache, body aches occurred the day after vaccination, but resolved the next day. The left arm became very irritating on the 25th with flaking skin and very itchy. Saturday the arm became inflamed which has remained through today. Redness, swelling, and hot to touch today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/25/2020,3.0,PVT,"blood pressure medication, cholesterol medication, multivitamin, Vitamin D, Melatonin, Collagen",none,"borderline high blood pressure, high cholesterol",,"Cilantro,","['Erythema', 'Fatigue', 'Headache', 'Inflammation', 'Pain', 'Pruritus', 'Skin exfoliation', 'Skin irritation', 'Skin warm', 'Swelling']",1,MODERNA,IM 923807,MD,40.0,F,"Right jaw pain, similar to what TMJ would be like, although I've never had TMJ and there's low stress in my life. Pain not relieved by Motrin/NSAIDs, constant 4/10, dull, and interferes with ability to chew.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,MIL,"Calcium, Benadryl",none,none,,none,"['Mastication disorder', 'Pain in jaw']",1,MODERNA,IM 923808,NV,57.0,F,Racing heart within 15 min. and kind of whoozy. And then okay. Came back to office and developed a headache about one hour after. Took 1000 mg of Tylenol; and I was feeling okay. Just arm was sore. Not extremely sore. 8 pm at night - started shaking; knees were knocking together; severe chills; and it took a few minutes to recognize what was happening - took temp. 99.4; took another 1000mg tylenol; went to bathroom and without notice - puked; woke up an hour after going to bed with worsened chills; 10:30 pm - temp 102.4; too early to take more Tylenol and so took pharmacy's version of Nyquil. Slept through the night after Nyquil but woke up with chills continuing - temp 103. 8 at 4:30 am; and then sat at side of bed and took tylenol 1000 mg and got up to go to bathroom and couldn't walk forward and felt my arm hurt really really bad; couldn't walk forward; I leaned against the wall and bounced against the next wall and kept walking and grabbed a bedroom doorknob and got into the bathroom and fell on toilet and then crawled to couch because I couldn't walk straight. Stayed on a couch for two hours and then it was gone. Fever and chills continued that whole day on 24th. Didn't eat/had no appetite. Christmas day -no fever. Felt shaky though - like I'd been super sick. No appetite still. Felt woozy and shaky inside (felt shaky inside) and that lasted for several days. Appetite still remains poor. 02 stats were low through all of it - four liters (up two liters than normal. Contacted: a pulmonologist - Dr. and she helped with O2 questions.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,WRK,am - two puffs of vevespi inhaler - 5:30 am (take twice a day),COPD; had Covid on 13th November and it ended on December 2nd (first day without a fever).,COPD,,none,"['Body temperature increased', 'Chills', 'Decreased appetite', 'Dizziness', 'Gait disturbance', 'Headache', 'Nervousness', 'Oxygen saturation decreased', 'Pain in extremity', 'Palpitations', 'Tremor', 'Vomiting']",1,PFIZER\BIONTECH,IM 923809,PA,46.0,F,"Pain at Injection site. Swelling, Redness, Induration at Injections site 5 days later Pain, Swelling, Induration of Left Axila",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,WRK,none,none,none,,none,"['Axillary pain', 'Induration', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Swelling']",1,MODERNA,IM 923811,SD,55.0,F,"Approximately 10 minutes after receiving injection the patient reported nausea and a tingling sensation in the roof of her mouth. Vital signs stable. Complaining of severe headache a short time later. symptoms did not subside and thus following a physician's recommendation, this person was transferred by ambulance to the ED",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,Unknown,unknown,unknown,,"Penicillin, Adhesives, Fragrance, Sulfa, chlorhexidine, gabapentin","['Headache', 'Nausea', 'Paraesthesia']",1,MODERNA,IM 923812,GA,40.0,F,"Approximately 5 minutes after vaccine administration, patient began to feel flushed and she was tachycardia. Brought patient away from public area, gave cool pack, oxygen and called EMS. EMS monitored patient and issue resolved within 20 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,MIL,,,,,,"['Flushing', 'Tachycardia']",1,PFIZER\BIONTECH,IM 923813,PA,48.0,F,Lightheadedness Tinlging in feet or head Given water and a snack; symptoms resolved. monitored for 30 minutes.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,WRK,Unknown,Unknown,Unknown,,Sulfa Citalopram Sertraline,"['Dizziness', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 923814,FL,30.0,F,"muscle aches, right upper arm. tenderness at the injection site. headache, not relieved by ibuprofen",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,150mg wellbutrin 1x/d,,anxiety/ depression,,codeine,"['Headache', 'Injection site pain', 'Myalgia']",1,MODERNA,IM 923815,NY,27.0,F,I experienced swelling in my face and lips. Hives on my chest and neck. I went to the ED 12/31. I felt nauseated and there was a burning in my stomach. I had a headache. I have been experiencing these symptoms at random since the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,WRK,ADDERALL,,"ADHD, Lyme disease.",,Latex. benzol peroxide,"['Abdominal discomfort', 'Headache', 'Laboratory test', 'Lip swelling', 'Nausea', 'Swelling face', 'Urticaria']",1,PFIZER\BIONTECH,IM 923816,WI,63.0,M,"Patient reported the tip of his tongue feeling ""tickly"" 10 minutes post injection. Denied any other complaints or concerns. At 20 minutes post injection, he reported it was starting to get better. Denied any other complaints or concerns at that time as well. Drank some water at this time and felt it was improving. Patient reported at 30 minutes post injection that the ""tickly"" feeling on his tongue was gone and requested to leave. Patient alert and oriented, no other signs or symptoms, denied any breathing concerns. Left clinic ambulatory. Encouraged to report to urgent care if symptoms returned or worsened. Agreed to plan and verbalized understanding.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"budesonide, zyrtec, pepcid, fenofibrate, levothyroxine, lidocaine, lisinopril, lorazepam, minoxidil",none,"hypertension, hyperlipidemia, GERD, Anxiety, Hypothyroidism, contact dermatitis, seborrheic keratosis, left sided tinnitus",,"lipitor, pollen, simvastatin",['Paraesthesia oral'],1,PFIZER\BIONTECH,IM 923817,IN,25.0,M,Soreness at the injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,,['Injection site pain'],1,PFIZER\BIONTECH,IM 923818,FL,40.0,F,"Possible administration error. Injection likely did not go into muscle and was given in subcutaneous tissue. On day 8 after injection patient developed hives, redness, swelling, induration, and warmth to anterior deltoid where vaccine was given. Day 9 local reaction worsened and swelling, redness, induration became bigger. Day 10 (today) continues with erythema, swelling, and warmth. No systemic signs of illness. No fevers. Skin intact and without blistering or necrosis.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/04/2021,8.0,PVT,Vitamin C and Vitamin D; Melatonin,No,No,,No,"['Incorrect route of product administration', 'Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site urticaria', 'Injection site warmth', 'Local reaction']",1,MODERNA,SYR 923819,WV,42.0,F,Sore arm and fatigue lasting 24 hours. Ibuprofen.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,Apriso ER; Losartan; Famotidine; Wellbutrin SR; Buspirone; Ompreprezole;,none,Chron's Disease; Hypertension; IBS; Ulcerative Colitis,sore arm,None,"['Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 923820,IN,31.0,F,Swollen and red at injection site. Warm to the touch and itchy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 923821,NY,45.0,F,"Received Pfizer Covid vaccine at 11:30 am and after 5 min , she experienced dry and itchy throat. No change in voice, no wheezing , able to drink and swallow water without difficulty. Vital signs and O2 saturation /oximetry were normal. After 30 min into observation, she c/o lightheartedness and both eyes were puffy. Vitals: BP 129/75, hr 91, O2 sat 99% at room air . Benadryl 50 mg IM given and client was taken to the Emergency room..",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,unknown,unknown,unknown,,shellfish dustmite,"['Dizziness', 'Dry throat', 'Periorbital swelling', 'Throat irritation']",1,PFIZER\BIONTECH,IM 923822,MA,36.0,F,"The day after the vaccine I had fatigue and body aches. Then on 12-23 fevers of 101.4, chills, body aches, diarrhea, vomiting, productive cough, and profuse sweating. Jan 1st I was in the shower and was dizzy with a headache. Loss of consciousness almost happened and that is when i got out of the shower and laid down. Went to the ED and was diagnosed with bilateral pneumonia",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,12/21/2020,12/22/2020,1.0,WRK,,,,,,"['Altered state of consciousness', 'Chills', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Pain', 'Pneumonia', 'Productive cough', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 923823,OR,57.0,F,"The patient started to complain of tongue tingling, given Benadryl and EMS called then allergic reaction continued to progress, given epi-pen and transported to the local emergency department. Patient vital signs stable throughout the event, able to ambulate to ambulance with standby assistance.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,"Lasix, Indocin, Mevacor, Levothyroxine, pro-AIR HFA, flovent, minipres, K-dur, imitrex, metoprolol xl, allergra, lactaid, MTV, advil, Vit C, Vit D",none,"SVT, Migraine, HTN, OA, hypothyroidism, OSA, seasonal allergies, edema, obesity, fatty liver, prediabetic",,"Barley, Bee venom, Budesonide-formoterol, Iodine contrast, licorice, Cirpo, sulfa, hydrocodone, Oxycodone, PCN","['Hypersensitivity', 'Paraesthesia oral']",1,MODERNA,IM 923824,NY,62.0,F,On Jan 1st developed small itchy resented area size of a penny. It further progressed over the next day or two to approximately 2 inch diameter reddened area not raised itchy. It is still itchy at time but fading to just a reddened ring around the 2 inch area. Slight itching,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/01/2021,9.0,UNK,Na,None,Nine,Itchy and red areas after flu vaccines,Septra Augmentin Bacitracin,"['Erythema', 'Pruritus']",UNK,MODERNA,IM 923825,MI,44.0,U,"13:40 patient complained of bilateral numbness of fingers and toes BP 180/125, HR 129, 100% spO2. Patient was monitored for 35 minutes and released home. Last set of vitals: BP 161/114, HR 80, 100% spO2. Patient referred to follow up with PCP. All symptoms had resolved at time of release.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,['Hypoaesthesia'],1,PFIZER\BIONTECH,IM 923826,,54.0,F,Sore arm Nausea Dizziness Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,SEN,"Atenolol, Lisinopril, Metformin, Victors, ASA, Meloxicam",None,HRN/DM,,"Vicoprofen, Imitrex, Darvocet","['Dizziness', 'Headache', 'Nausea', 'Pain in extremity']",UNK,MODERNA, 923827,IL,40.0,F,"Painful right axillary adenopathy developed upon waking on 1/4/21. On 1/5/21, noted red itchy skin patch overlying injection site on right arm. At time of submission of this form, both issues are still present and persist.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,PVT,"Lo lo estrin with iron, escitalopram, and ibuprofen.",None.,None.,,None.,"['Injection site reaction', 'Lymphadenopathy', 'Rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 923828,,52.0,F,"C/O swelling , soreness, and redness to injection site. States it is still that way 5 days later and itches. Denies increased in size, denies pus.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PUB,,,,,NKA,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 923829,PA,40.0,M,Swollen Lymphnodes above right clavical and under right armpit. Sore joints in right arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/02/2021,3.0,PVT,"Fish Oil, Ibuprofen, Multivitamin",,Asthma,,,"['Arthralgia', 'Lymphadenopathy']",UNK,MODERNA, 923830,CA,63.0,M,fever 101-102 on 12/30/2020 with confusion,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"aspirin 81 mg, gabapentin 100 mg qd, ibuprofen 400 mg prn, januvia 100 mg qd, vemlidy 25 mg qd, diovan-hct 160-12.5 mg qd","htn, dm, chronic hep b","as above - htn, dm2, chronic hep b, history of ureteral stone",,NKA,"['Blood lactic acid', 'C-reactive protein', 'Confusional state', 'Full blood count', 'Metabolic function test', 'Pyrexia', 'Red blood cell sedimentation rate']",1,MODERNA,IM 923831,ND,26.0,F,"Injection site became itchy, and then around the entire area, shoulder area, down arm. Would lessen, then become worse again, Injection site ice packed, hydrocortisone cream applied to area at 5:45pm and 6:10pm with some relief. Small welts noted at times, but decreased with treatments. Benadryl 25mg PO at 5:15pm, Benadryl 12.5mg PO Chewable at 5:45pm and Benadryl 25mg PO at 6:10pm, all on 1/5 Repeated 25 mg PO at 8:30 on 1/6 for slight itchy HR regular, no swelling in face or tongue, no shortness of breath, no headache or visual disturbances. No nausea or vomiting, or diarrhea. Drove to home, took bath and slept well that night. Still reports general itchiness throughout body on 01/06 with some relief from benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,None,None,None,,Sulfa Meds,"['Condition aggravated', 'Injection site pruritus', 'Pruritus', 'Urticaria']",1,MODERNA,IM 923832,PA,37.0,F,"8:00 am: tongue numbness and reported to observer 8:05 am: tongue swollen lips numb 8:10 am: registering in ER tachycardia. Throat mouth dry and tight change to hoarse voice lightheaded. EpiPen administered. Ekg done. Other meds provided: 500 ml saline bolus. Famotidine, prednisone, benadryl Angioedemia and readmittance to ER approximately 18hrs later: prednisone,epipen, benadryl iv and po, famotidine, saline bolus",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,"Allegra, hydochlorothiazide, spirlanolactone, norvasc,famotidine, metformin",None,"Idiopathic angioedema, HTN, PCOS",,"PCN, latex, coconut","['Angioedema', 'Dizziness', 'Dry mouth', 'Dry throat', 'Dysphonia', 'Electrocardiogram abnormal', 'Hypoaesthesia oral', 'Swollen tongue', 'Tachycardia']",1,PFIZER\BIONTECH,IM 923833,MI,27.0,F,"Patient developed acute pain, itching and warmth at site of vaccine administration. She developed a rash extending to the top of the LEFT shoulder into the LEFT earlobe",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,9/1/2020 localized reaction to flu vaccine and Varicella 6/2017. Patient had localized redness and swelling to the site 3 days a,no allergies: Previous delayed ( 3 days after administration) injection site reaction (localized redness and pain) and flu shot in 2020 and after varicella vaccination in 2017. Tolerated first dose of vaccine without adverse reaction,"['Injection site pruritus', 'Rash', 'Vaccination site pain', 'Vaccination site warmth']",2,PFIZER\BIONTECH,IM 923834,VA,60.0,M,"Patient may have received double dose, 58 mcg, in single injection. Unsure of exact dilution used. Once one vaccine was administered and error was discovered, no other doses administered. Patient experienced side effects consistent with vaccine side effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Adverse drug reaction', 'Incorrect dose administered']",1,PFIZER\BIONTECH,IM 923835,MD,59.0,F,"Patient received moderna vaccine and while waiting started to have tingling of tongue, had to be taken to the ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"azathioprine, vit c, budesonide, calcium, Celebrex, vit d, prempro, vit b1, omeprazole, vitamin a","autoimmune hepatitis, rheumatoid arthritis","autoimmune hepatitis, rheumatoid arthritis",,solumedrol,"['Chest X-ray', 'Electrocardiogram', 'Laboratory test', 'Paraesthesia oral']",UNK,MODERNA, 923836,PA,24.0,F,Chills; Headache; Elevated temperature (100.7F),Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Body temperature increased', 'Chills', 'Headache']",1,MODERNA,IM 923837,IN,24.0,M,"Was fine for ~8 hours then started to feel ?off? after completing an upper body workout. I then felt nauseous and threw up, and my body began to ache. 12 hours post vaccination I began to develop a fever of 99.8 with the use of acetaminophen and had severe chills / muscle aches. The fever progresses to 101.1 about 36hours post vaccine and declined to 100.8 48 hours post vaccine. By 72 hours the fever was gone as well as all symptoms excluding fatigue and a slight headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,OTH,Melatonin 3mg QD fluoxetine 20mg QD Flinstones multivitamin QD,POSITIVE COVID TEST. Was cleared to return to work 6 days prior to receiving vaccine,N/a,,Penicillin,"['Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 923838,ID,36.0,F,Under arm pain on arm of injection. Swelling of under arm as well. Lasting 6 days. Did require me to take over the counter pain relief.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/01/2021,6.0,PVT,Lexpro 10 mg daily Vitamin D3 Multi Vitamin,,Anxiety,,Amoxicillin,"['Axillary pain', 'Injection site swelling']",1,MODERNA, 923839,IN,58.0,F,Pfizer COVID vaccine gine. Headsche weakness and extreme conjunctivitis present,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Amlodipine 5mg dly Vit D 1000IU dly,None,None,,None,"['Asthenia', 'Conjunctivitis', 'Headache']",UNK,PFIZER\BIONTECH, 923840,FL,29.0,F,Onset of disorientation and epitaxis from the L naris 90 minutes after injection. Resolved without medical intervention.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,MIL,"Liocaine patch, naproxin",None,R hip pain.,,NKDA,"['Disorientation', 'Epistaxis']",1,PFIZER\BIONTECH,IM 923841,MO,56.0,F,"site redness, little warm and itchy about dime size for couple days after, felt a little sluggish for 1 day or 2 after. Last Wednesday 12/30/20 injection site came back with itching, redness about a dime size again, never gone away. Last night it was bigger about a size of a quarter, warm, red and itchy, took Zyrtec. This morning 1/6/21 it is about the size of my palm, warm, little itchy. I had headache and neck stiffness last week, but none as of yesterday. Forgot to mention on phone this morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,01/05/2021,14.0,PVT,,,,,,"['Headache', 'Injection site erythema', 'Injection site pruritus', 'Injection site warmth', 'Musculoskeletal stiffness', 'Sluggishness']",1,MODERNA,IM 923842,GA,19.0,F,"Pt. reports that she noticed her left arm where she received Moderna COVID- 19 Vaccine EUA was red, swollen and itching this morning (01/06/2021) at approximately 7:45 AM. Pt. also states that she started taking Bactrim on 01/05/2021 for a UTI and she took only one dose prior to the event. Reports taking Amoxicillian for stye last week and was switched to Bactrim on Monday for a UTI but did not take first dose of Bactrim until Tuesday 01/05/2021. Pt. also reports all over itching including legs and face it red and blotchy on both cheeks that also began today. Pt. came into clinic on 01/06/2021 at 1:54 PM for visual evaluation of arm. Upper outer left arm (left deltoid area) has red rash 55MM Length & 30 MM Wide Area is also warm to touch. Pt. used cool compress for the redness, swelling and Benadryl for the itching.Pt. reports that swelling and redness has improved but itching continues along with aching. Reports a numb feeling in the area of the shot on left deltoid. Pt. also reports left axillary tenderness but states that started shortly after vaccination. Patient's mother notified primary care provider due to current use of Bactrim but no actual visit to doctor was made. Pt. instructed to continue to monitor for side effects and to contact HD and primary healthcare provider if symptoms worsen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PUB,No medications at time of vaccination.,None,None,,NKA,"['Erythema', 'Hordeolum', 'Injection site erythema', 'Injection site hypoaesthesia', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Pruritus', 'Rash erythematous', 'Rash macular', 'Tenderness', 'Urinary tract infection']",1,MODERNA,IM 923843,PR,52.0,F,"Fever, body aches, severe headaches, the vaccine site is hot and swollen and painful",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Zoloft ,pepcid,protonix, advil liquid gels",,Stress related muscle spasms,,Feldene,"['Headache', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 923844,WI,16.0,F,"Patient had completed the VAR form prior to the clinic. Staff was aware that only ages 18 and over could get immunization. They allowed her to have the shot with parental approval, which we as the vaccinators did not notice or approve of.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,SEN,,,,,,['Product administered to patient of inappropriate age'],1,MODERNA,SYR 923845,MA,56.0,F,"States she felt her heart was racing. Denies CP, SOB. She was talking without difficulty. No rash or hives. Walking without difficulty. No dizziness. Evaluated by EMS. VS-156/70, 90, 22. O2 Sat 100%. Recheck-148/76, 86, 18, 100%. States she felt it could be due to anxiety. No history of anxiety. She declined transfer to hospital. Left to go to work. No complaints. Left at 6:45PM.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,None,None,None,,NKA,['Palpitations'],1,MODERNA,IM 923846,ND,43.0,M,"On 12/24, at 8:30a I began to get nauseated which lasted about 2hrs. Around 1am I woke up with SOB which continued thru the night, with off and on sleep. I woke back up at 5:45am, went to work with the SOB which lasted until 12N and resolved on its own. Around 3-330pm I began to feel feverish and had chills and was told I was disoriented. My temp was 100.5, HR 122 R 34 BP 170/100 O2-93%. I notified the DON of my feelings who advised me those were possible side effects of the vaccine and made me continue to work until I just couldnt take the feelings anymore and went to the ER. I was there for about 2 hrs and my body began to calm down. I took taken 100mg of Tylenol on my own just to help with the fever which did break shortly and I have been fine every since. I was positive for COVID 12/14.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,PVT,"Metoprolol Succinate 50mg,",no,Hypertension,,Maize plant,"['Chills', 'Disorientation', 'Dyspnoea', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative', 'Sleep disorder']",1,MODERNA,IM 923847,WA,43.0,M,"Nausea, Diarrhea, Sore throat, headache and congestion. Started an hour after receiving the vaccination. Symptoms increased the following day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,Irritable Bowel Syndrome,,Promethazine,"['Diarrhoea', 'Headache', 'Nausea', 'Oropharyngeal pain']",1,PFIZER\BIONTECH,IM 923848,IN,42.0,F,"Tingling in left arm radiating to hand, little finger. BP 110/80 HR 90 @ 1139. Injection site has no redness or swelling. BP 120/80 HR 70 @ 1150. Tingling better, feels ok to leave.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,Advil & Tylenol PRN,None,None,,NKDA,['Paraesthesia'],1,MODERNA,IM 923849,CA,63.0,M,"fever 101-102 on 12/30/2020 followed by confusion, headaches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"asa 81, diovan- hct 160-12.5 mg qd, januvia 100 mg qd, ativan 0.5 mg tid prn, vemlidy 25 mg qd, gabapentin 100 mg qd, ibuprogen 400 mg q6h prn","htn, dm2, chronic hep b, occipital neuralgia",as above,,nka,"['Blood lactic acid', 'C-reactive protein', 'Confusional state', 'Full blood count', 'Headache', 'Metabolic function test', 'Pyrexia', 'Red blood cell sedimentation rate']",1,MODERNA,IM 923850,CO,26.0,F,I had vomitting and that was moderate. The following day I was nauseous. My arm was pretty swollen and pain in the arm for two day. I had a headache that was pretty severe for two days. The third day I felt a little bit of arm soreness but I could use my arm a little better. I started having a little bit of a rash at the point of where I received the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,UNK,"I take prenatal vitamins, zofran, zoloft.",No,I have occasional asthma,,I am allergic to cephalexin,"['Headache', 'Injection site rash', 'Nausea', 'Pain in extremity', 'Peripheral swelling', 'Vomiting']",1,MODERNA,IM 923851,CA,56.0,F,"Numb lips, tongue. Benadryl given",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Unknown,Unknown,Unknown,,NKA,['Hypoaesthesia oral'],1,PFIZER\BIONTECH,IM 923852,MO,28.0,F,"Starting on 01/04/21 Employee noticed red swollen area below injection site. States itching warm to the touch. Area is 7 X 4.5cm on posterior of left arm not deltoid. States took 2 doses of Benadryl with minimal improvement. Explained conservative interventions including, cool compresses, IBU and OTC allergy medication if allowed by PCP. Employee verbalized understanding and will continue to monitor site. Employee advised to contact patient safety as the injection was misplaced by the vaccinator.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/04/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Product administered at inappropriate site']",1,MODERNA,IM 923853,IA,52.0,M,injection site tenderness; swelling/pain of lymph node left armpit,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,PVT,fish oil Vit D,None,None,,None,"['Injection site pain', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 923855,TX,38.0,F,"large, diffuse local reaction including erythema, edema, tenderness, itching around whole deltoid area where injection was given",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/02/2021,6.0,PVT,"multi-vitamin, Nasacort nasal spray, calcium supplement, elderberry, omega",seasonal allergies,seasonal allergies,,None,"['Injection site erythema', 'Injection site oedema', 'Injection site pain', 'Injection site pruritus', 'Local reaction']",1,MODERNA,IM 923856,MN,69.0,F,"Extremely tired, arms and legs felt like lead. Sharp pain top of ankles. Tireness, achiness, joint pain, muscle pain, headache. Feeling unwell.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,Prilosec,no,no,,no,"['Arthralgia', 'Fatigue', 'Headache', 'Limb discomfort', 'Malaise', 'Myalgia', 'Pain']",1,PFIZER\BIONTECH,IM 923857,WI,30.0,F,"At approximately 1630, patient was getting ready to leave the vaccine clinic. She advised writer that she had a strong metallic taste in her mouth. It started 10-15 minutes after the injection. Denied all other symptoms that could be considered a side effect or allergic reaction to the vaccination. Advised patient she could stay later for further observation. Patient declined to stay. She felt fine otherwise. Patient was further advised if develops shortness of breath, or throat tightening to call 911 immediatley. Patient verbalized understanding. She indicated that she does have an epi pen due to allergies and will use it if necessary. Called patient at approximately 1830. She informed writer that she did have the strong Metallic taste in her mouth that started 15 minutes after the immunization and it lasted for about 1 hour. She reports that she was slightly light headed once she got home. Patient is not sure if it is due to starting night shift last night or if it was from the vaccine. Patient encouraged to increase her water intake. She was also encouraged to call PCP's office if light headedness does not completely resolved. If develops life threatening symptoms, to call 911. She was in agreement with plan. Writer will completed VAERS report tomorrow.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,Unknown,None that writer is aware of,"Neck pain Mild intermittent asthma without complication Allergic rhinitis, seasonal� Esophageal reflux � Migraine",,"Banana - Anaphylaxis, Hives, Itching Kiwi Extract - Anaphylaxis, Hives Shellfish Allerg - Anaphylaxis Shellfish-derived Products - Anaphylaxis, Hives, Itching Cat Hair Extract - Itching, Sinusitis Pollen Extract - Itching, sinusitis","['Dizziness', 'Dysgeusia']",1,PFIZER\BIONTECH,IM 923858,ME,44.0,F,Red circular area that started day two. Seemed to not really grown until day 7 and has gotten bigger on day 8 and 9 and arm is sore again with a hard lump under injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,Ambien 10 mg QHS PRN,No illnesses,"Insomnia, IBS",,"Adhesive tape, oxycodone, Vicryl sutures","['Injection site erythema', 'Injection site mass', 'Pain in extremity']",1,MODERNA,IM 923859,NY,22.0,M,"Chills, upper arm ache, stomach ache, and fever (100.7) at about 11 am on Wednesday January 6, 2021. Called employee health and went to get a COVID test",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,None,None,None,,None,"['Abdominal pain upper', 'Chills', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH,SYR 923860,FL,47.0,F,7 days after receiving the vaccine I have developed a red patch that is hot to the touch at the injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,OTH,None,"I was sick 2 days before a holiday. Took pharmacy test which came back negative. I had a fever of 101 and 102, severe chills and body aches,",None,,None,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,IM 923861,MA,41.0,F,"Approxametly 12 hours after receiving the vaccine I had feelings of nausea, headache, left arm pain and general malaise. This lasted about 2 hours and then subsided. For the last week, I've had off and on headaches and feelings of tiredness. I've also had soreness in left arm at the injection site. Yesterday, 1/5/2021 I noticed increased redness, warmth and a raised area at the injection site. It's hard and a little itchy. I've also had soreness in my neck and arm pitt. I have reached out to employee health through the hospital that i work at and whom i recieved that vaccine from in regards to my symptoms. The only invervention I've taken has been taking tylenol for a headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,Tylenol,,headaches,,"Allergies to Bee stings, bananas and avocado's.","['Axillary pain', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site urticaria', 'Injection site warmth', 'Malaise', 'Nausea', 'Neck pain', 'Pain in extremity']",1,MODERNA,IM 923862,KY,63.0,F,"Temperature 101, headache, ears hurt, body aches , nauseated",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Fish oil, eye vitamins. vit d. Tumeric",Had a cold,None,,"Aspartame, sulfa","['Body temperature increased', 'Ear pain', 'Headache', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,SYR 923863,WI,44.0,F,Persistent migrane pain with nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,acetaminophen (TYLENOL) 500 MG tablet Apply topically to the affected daily for acne once daily.. clindamycin (CLINDAGEL) 1 % gel Take 10 mg by mouth Every 8 (Eight) Hours As Needed for Muscle Spasms. fluconazole (DIFLUCAN) 150 MG tablet,None,Bipolar disorder (*) Allergic rhinitis Allergic asthma (*) Presence of (intrauterine) contraceptive device Migraine headache (*) Carpal tunnel syndrome Chronic lower back pain Spinal stenosis of lumbar region Eczema Breast pain in female Acute right lumbar radiculopathy Sacroiliac joint dysfunction of right side �,,Metoclopramide and Prednisone,"['Condition aggravated', 'Migraine', 'Nausea']",1,PFIZER\BIONTECH,IM 923864,MO,30.0,F,"Employee here for COVID vaccine reaction, Left upper arm in deltoid area is red, swollen, warm to the touch. States this reaction started 01/05/21 with redness and itching area was outlined in pen at that time measured 7 X 9cm. The area has now expanded and is 11.5 X 11.5cm. States it is itching tender to the touch, swelling seems to wax and wane. No medication taken at this time. Redness does appear to be spreading toward collar bone and streaks are noted extending up shoulder. Recommending that the employee get seen for this reaction by PCP or walk in clinic to rule out possible cellulitis. Employee verbalizes understanding and agrees.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/05/2021,8.0,PVT,,,,,,"['Condition aggravated', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site streaking', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 923865,TX,40.0,F,"approximately 3 hours after vaccine, complaining of L arm pain. Patient concerned the vaccine was placed ?too high.? Patient reports she spoke with RN?s on her unit and showed location of vaccination and was educated it was placed too high. Patient reports sore arm after 1st dose but reports, ?this feels so much worse. I can barely lift my arm.? Patient educated to rotate Tylenol and motrin according to the medical directive for prescription medication and to apply ice to injection site. Patient educated to call vaccine support line for worsening symptoms, patient verbalized back understanding and denied further questions at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Injected limb mobility decreased', 'Pain in extremity', 'Wrong technique in product usage process']",2,PFIZER\BIONTECH,IM 923866,NM,33.0,F,"Fully body itch, no redness and no rash",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,"Claritin, Birth control, breo inhaler, incruse inhaler, metformin, montelukast, probiotics","asthma, allergies, insulin resistance, Polycystic ovary syndrome (PCOS)",,,"penicillin, Sulfa, Keflex, Aleve, tree, weeds, mold, pollen",['Pruritus'],1,MODERNA,IM 923867,NY,28.0,F,Soreness at injection site day 2 that resolved. Diarrhea days 5- present. Hives surrounding injection site started day 9 post injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/05/2021,9.0,PVT,"Prenatal vitamins, fish oil supplement, lactaid supplement, Nasocort, vitamin D",None,"Dermatitis herpetiformis, celiac disease",,Phenethyl alcohol- anaphylaxis. Reglan- visual changes,"['Diarrhoea', 'Injection site pain', 'Injection site urticaria']",1,MODERNA,IM 923868,IL,24.0,F,"Patient is a 24 years old female seen today for Follow-Up (Received covid vax on 12/23, swollen, painful lymphnodes in L armpit and L side of neck) The LE is seen today on call with chief complaint of swelling of the left anterior neck. She received the Pfizer co bid 19 vaccine on 12/23 in the upper outer left on her. On the 25th she noted some discomfort in the axilla which then persisted all week. She did not have any fever or chills or malaise. She noted no redness in the axilla or in the area of the injection. She then developed visible swelling in the anterior left side of her neck and a sonogram was done which shows 6 areas of enlargement the largest one is 1.7 cm in diameter. Patient has the image on her phone and this was reviewed with her. She has no discomfort in the right axilla and no swelling elsewhere in the neck. She has no history of similar swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/04/2021,12.0,WRK,None,None,Spina Bifada Occulta History of Raynauds Syndrome,,None,"['Discomfort', 'Lymph node pain', 'Lymphadenopathy', 'Swelling', 'Ultrasound scan abnormal']",1,PFIZER\BIONTECH,IM 923869,ME,37.0,F,6 days after administration I have a large area of redness at the area of injection (15x10cm) that is also slightly raised,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/06/2021,6.0,WRK,Prenatal vitamin,None,Eczema,,"PCN, sulfa, and kiwi","['Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 923870,WA,46.0,F,"Rash on my back since last night. I saw my doctor in a visit today and she believes that this is hot tub folliculitis, but she wanted me to report anyway.There are about 30 pustules on my back that are uncomfortable but not painful, nor itching. This has not worsened. Prescribed by doctor is topical medication. I will begin this medication later this afternoon.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,PVT,"Omeprazole, Tylenol",None known,HTN,,None known,"['Discomfort', 'Folliculitis', 'Pustule', 'Rash']",1,MODERNA,IM 923871,,54.0,F,"PATIENT RECEIVED VACCINE ON DEC 18TH. ON DEC 30, PATIENT BEGAN EXPERIENCING HAND AND JOINT PAIN THAT SPREAD TO ENTIRE UPPER BODY. SHOOTING PAINS UP HER NECK AND DOWN HER ARMS. DEVELOPED ITCHY RASH ALL OVER UPPER BODY AS WELL AS HEADACHE AND SWOLLEN LYMPH NODES. CRP WAS 3.6 AND SED RATE 25. COVID TEST WAS NEGATIVE. PATIENT PUT ON MEDROL DOSE PACK AND SYMPTOMS RESOLVED IN 5 DAYS",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/30/2020,12.0,UNK,,,,,,"['Arthralgia', 'C-reactive protein increased', 'Headache', 'Lymphadenopathy', 'Neck pain', 'Pain', 'Pain in extremity', 'Rash pruritic', 'Red blood cell sedimentation rate increased', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 923872,MN,50.0,F,"Severe Nausea within 30 minutes - has not subsided - still present after 24 hours Chest Pain - began after 10 hours - reduced pain after 24 hours, but still present Headache - began after 8 hours - still present Cough - began after 8 hours - still present Sore Throat - began after 8 hours - still present Shaking hands - began next morning - still present",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Warfarin Linzess Oxycodone Vit B12 Vit D Iron,,Recurrent Diverticulitis - hospitalized 3 times 2020 Anticoagulation Chronic Pain Avascular Necrosis Multiple Joint Replacements,,Sulfa antibiotics,"['Chest X-ray', 'Chest pain', 'Cough', 'Electrocardiogram', 'Headache', 'Laboratory test', 'Nausea', 'Oropharyngeal pain', 'Tremor']",1,PFIZER\BIONTECH,IM 923873,MO,36.0,F,Day of injection developed a nickel sized raised bump at injection site. 1 week after this red area began enlarging; did not start subsiding until 1/5/2021. See photo taken 1/3/2021: perimeter was red and raised. Itching started on 1/4/2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/22/2020,0.0,PVT,,,,,mushrooms penicillin,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 923874,IN,33.0,F,"103 fever, chills, severe muscle pain, hypersensitive nerves, chest pain, headache, lightheaded",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,None,None,None,,None,"['Chest pain', 'Chills', 'Dizziness', 'Headache', 'Myalgia', 'Neuralgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 923875,NJ,0.58,M,"Abnormal eye movements (multiple an hour) the following day (12/19). He was taken to local emergency room and admitted to neurology for continuous video EEG, sedated for brain MRI, ophthalmology exam. All tests were normal, but movements have continued. He saw ophthalmology for a dilated exam today, 1/6/2020, and they referred us to neuro ophthalmology.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,12/18/2020,12/19/2020,1.0,PVT,Vitamin D,"Upper respiratory infection (covid negative), vomiting (12/14)",Bloody stools from proteins in breastmilk - Improved with removal from maternal diet,,"Intolerances through breastmilk (dairy, soy, peanut)","['Electroencephalogram normal', 'Eye movement disorder', 'Magnetic resonance imaging brain normal', 'Ophthalmological examination abnormal', 'Tic']",2,SANOFI PASTEUR,SYR 923876,AZ,33.0,F,"Headaches, nausea, slight fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,Birth control- Sprintec,No,No,Flu shot,No,"['Headache', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 923877,IN,52.0,M,"Neck pain, left jaw pain, headache in both temple regions",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,"Novolog, 81MG aspirin, Metformin",,Diabetic,,Lisinopril,"['Headache', 'Neck pain', 'Pain in jaw']",1,MODERNA,SYR 923878,KY,41.0,M,"FLUSHING, STIFFNESS IN LEFT ARM MOVING UPWARDS TOWARD NECK. NUMBNESS IN THROAT/MOUTH/FACE. ADMINISTERED ORAL DIPHENHYDRAMINE 25MG AND CALLED PT'S PCP. PCP WAS ABLE TO SEE PATIENT IMMEDIATELY AND PATIENT TRANSPORTED TO THE OFFICE (ON-SITE).",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Flushing', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Injected limb mobility decreased', 'Pharyngeal hypoaesthesia']",1,MODERNA,IM 923879,CA,38.0,F,"WITHIN ONE HOUR OF RECEIVING VACCINATION DEVELOPED 102.6F FEVER, HAVE HAD RECURRENT FEVER EVERYDAY ALONG WITH BODY PAINS, CHILLS FOR 1 WEEK NOW AND COUNTING CURRENTLY TAKING MOTRIN & TYLENOL TO ALEIVE FEVER",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,"currently taking levothyroxine, motrin, claratin, Vit D",none,thyroidemctomy for thyroid cancer,,Pseudophed,"['Chills', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",UNK,MODERNA,IM 923880,MO,49.0,F,"Employee here with COVID vaccine reaction on left arm in deltoid area. The area became on 01/29/20 but then the redness went away, it came back on 01/05/21 the area is red swollen and hot to the touch. Employee complains that the skin is taught and feels like it pulls when she moves her arm. The area is 10.5 X 8cm and has non defined lines with possible streaking. Explained that the employee should contact her PCP or go to a walk in clinic for evaluation and treatment. Employee verbalized understanding and agreed with plan.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/05/2021,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site reaction', 'Injection site streaking', 'Injection site swelling', 'Injection site warmth', 'Skin tightness']",1,MODERNA,IM 923881,SC,46.0,F,"faver 102, body aches, joint pain after first dose",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"biotin, multivitamin, clarinex, protonix, klonopin",,celiac,,"macrobid, cipro, wellbutrin, celexa, effexpr, hydrocodone","['Arthralgia', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 923882,ME,48.0,F,"chest tightness, flushing, swollen lips, tingling in the left arm, no shortness or breath, no palpitations, no lightheadedness, no dizziness, no nausea or vomiting, no rash, no redness, no cough, no tongue swelling Started within 20-30 minutes of receiving the vaccine Received 25mg of Benadryl with improvement",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,Cosentyx,none,psoriatic arthritis,,"Iodine, tree nuts","['Chest discomfort', 'Flushing', 'Lip swelling', 'Paraesthesia']",2,PFIZER\BIONTECH, 923883,TX,40.0,F,"Symptoms - ? approximately 3 hours after vaccine, complaining of L arm pain. Patient concerned the vaccine was placed ?too high.? Patient reports she spoke with RN?s on her unit and showed location of vaccination and was educated it was placed too high. Patient reports sore arm after 1st dose but reports, ?this feels so much worse. I can barely lift my arm.? Recommendation? Patient educated to rotate Tylenol and motrin according to the medical directive for prescription medication and to apply ice to injection site. Patient educated to call vaccine support line for worsening symptoms, patient verbalized back understanding and denied further questions at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Injected limb mobility decreased', 'Pain in extremity', 'Product administered at inappropriate site']",2,PFIZER\BIONTECH,IM 923884,PA,40.0,M,Dizziness Lightheadedness Chills Sweating Hypotensive Monitored for 45 minutes. Placed in Trendelenberg position. BP 142/100 EMS was called to evaluated. Patient refused to go with.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/26/2020,0.0,WRK,unknown,unknown,unknown,,NKDA,"['Chills', 'Dizziness', 'Hyperhidrosis', 'Hypotension']",1,PFIZER\BIONTECH,IM 923885,MI,34.0,F,None,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,UNK,Levothyroxine,,,,,['Unevaluable event'],UNK,PFIZER\BIONTECH, 923886,NM,70.0,F,"severe headache, dizziness, vomiting, elevated bp, turned pale, legs shaking scratchy throat, rash to face and throat,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,"MULTI VIT,EYE VIT, TUMMERIC, VT D, VT C,CALCIUM, JOINT PILL TYNOL ARTHRITIS,VALTREX,",NONE,"GERD,ARTHRITIS",,"ALL CYLINS, ALTT MYCENS.ALL CYCLENS,CODINE, IODINE","['Blood pressure increased', 'Dizziness', 'Headache', 'Pallor', 'Rash', 'Throat irritation', 'Tremor', 'Vomiting']",2,PFIZER\BIONTECH,IM 923887,GA,34.0,M,"RAISED, RED RASH ON LEFT ARM 5 DAYS STATUS POST VACCINATION. RARELY ITCHED. 3/X4 INCHES",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/02/2021,5.0,PVT,MULTIVITAMIN IBUPROFEN 800MG,NONE,NONE,,NONE,"['Rash', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",1,MODERNA,IM 923888,MO,55.0,F,"Normal initial soreness for first 3 days. Started itching around vicinity of injection site. Soreness returned which was more localized and noticed small bump under surface of skin, about the size of a golf ball, warm to touch and skin slightly red. Lot # is at home",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/05/2021,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 923890,CA,49.0,F,"Moderna Covid-19 Vaccine EUA I had an immediate headache and metallic taste in my mouth within 1 hour of the vaccine. Those symptoms went away within 1-1/2 hours of the vaccine. Then on Saturday morning at 2am I developed chills, body and joint ache diffusely. I took 600 mg of ibuprofen at that time and they symptoms were gone by Saturday morning at 9:30am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,"Lyrica, Methotrexate, Leucovorin, Estradiol",None,"Fibromyalgia, Rheumatoid arthritis",,"Enbrel, Humira, Xeljanz","['Arthralgia', 'Chills', 'Dysgeusia', 'Headache', 'Pain']",1,MODERNA, 923891,WV,29.0,F,"Day one 1/3/2021 of reaction there was a knot and tenderness at injection site, day 2 1/4/2021Redness and itching at injection site (area approximately 1.5-2 inches in width and length. Drowsiness and dizziness were also present on 1/4/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/03/2021,10.0,SEN,Labetalol,,Hypertension,,NKA,"['Dizziness', 'Injection site erythema', 'Injection site nodule', 'Injection site pain', 'Injection site pruritus', 'Somnolence']",UNK,MODERNA,IM 923892,TX,49.0,F,"I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was sitting on my arm and very heavy at the site. I went to the waiting area and the last 5 minutes and I started feeling weird, kind of getting dizzy and my heart started racing really fast. Am I can tell I was getting really hot and my face was flushed and my heart was racing and my hands started shaking, trembling almost like I couldn't control it. I've never experienced something like this. The part that really scared me was my heart racing like it was going to come out of my chest. They called a code, put me in a wheel chair and took me to the ER (where I work). They took my blood pressure which was really high, they did EKG, blood work and urine test. They kept me there for about five hours, while watching me. And the last weird thing that happened at one point I felt like liquid was running thru my body and my feet were really cold for several hours, It felt like someone was pouring liquid over me. I kept asking the nurse if this is normal and no one knew what to tell me. After everything started slowing back down and it had been a couple hours and the next day i felt like I had a slight head ache and felt out of it, kind of like I had a hangover and of course my arm was really sore. The Doctor in the ER did advise me not to get the second dose as it will be worse than the first one.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,Ziac (blood pressure ) Zoloft Levothyroxine (thyroid medication) Multi Vitamin Calcium Trisprintec (birth control) Generic Sudafed,,Hypertension Throid,,Arithimycin Tetracycline,"['Blood pressure increased', 'Blood test', 'Dizziness', 'Electrocardiogram', 'Fear', 'Feeling abnormal', 'Feeling hot', 'Flushing', 'Headache', 'Immediate post-injection reaction', 'Injection site reaction', 'Limb discomfort', 'Pain in extremity', 'Palpitations', 'Peripheral coldness', 'Tremor', 'Urine analysis']",1,PFIZER\BIONTECH,SYR 923893,LA,73.0,F,"During the patient's 15 minute post COVID vaccine observation, she reported feeling dizzy and unsteady on her feet. Her BP 188/78. HR 98. Pulse Ox 98% on room air. She did state she was anxious about recieving vaccine. While obtaining health history, the patient revealed she was feelin dizzy and unsteady as she was exiting the car this morning. She did not eat breakfast and also recently started allergy shots. She had skipped her allergy shot this week because of this appointment for COVID vaccine. Patient was monitored for an aditional 30 minutes. Vital signs returned to normal but she was still feeling dizzy. Her husband was called to pick her upand she was instructed to follow up with PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,,,,,NKA,"['Anxiety', 'Balance disorder', 'Dizziness']",1,PFIZER\BIONTECH,IM 923894,AR,52.0,F,Rash on right torso (belt line) side of the back of and front of thighs and buttocks,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,"benazepril, hydrichlorothiazide, cymbalta",Shingles 4 weeks ago on face,crohns disease,,Sulfa/ latex,['Rash'],1,PFIZER\BIONTECH,IM 923896,CA,40.0,F,"Lightheadedness, dizziness - ""felt like the room is spinning,"" weakness and tingling all extremities",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Asthenia', 'Dizziness', 'Paraesthesia', 'Vertigo']",2,PFIZER\BIONTECH,IM 923897,ME,52.0,F,"Patient had redness at injection site 4hrs after receiving vaccine on 12/29. Patient started having red, indurated area around vaccine site on 1/2/2021. Site around vaccine injection is now red, indurated, firm, and about 2in across.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,WRK,,,,,Penicillins,"['Injection site erythema', 'Injection site induration']",1,MODERNA,IM 923898,CA,56.0,F,Patient reports vertigo and it comes and goes since vaccine. She says the room is spinning and was unable to drive and not able to care for patients.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/29/2020,5.0,PVT,,,,,,"['Loss of personal independence in daily activities', 'Vertigo']",UNK,PFIZER\BIONTECH, 923899,CT,40.0,F,Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I eat shrimp.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,WRK,,,,,"Shrimp, penicillin, metronidazole","['Feeling hot', 'Injection site warmth', 'Paraesthesia oral', 'Pruritus']",1,PFIZER\BIONTECH,SYR 923900,MO,51.0,F,Red Circle around injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,01/06/2021,14.0,PVT,,,,,,['Injection site erythema'],1,MODERNA,IM 923901,WI,54.0,F,"LEFT SIDED CHEST PAIN, SHORTNESS OF BREATH, FELT WARM AND FLUSHED",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"ALBUTEROL INHALER AS NEEDED, ATORVASTATIN 20MG DAILY, CITALOPRAM 20MG DAILY, GLIMEPIRIDE 1 MG DAILY, LISINOPRIL 20MG DAILY. ASPIRIN 81MG DAILY",,"DIABETES, HYPERTENSION, DEPRESSION, ASTHMA",,"PENCILLIN (HIVES, GI UPSET), IODINE (HIVES, RASH), SULFA (UNKNOWN), IODINATED CONTRAST DYE (HIVES), LATEX (HIVES)","['Chest pain', 'Dyspnoea', 'Feeling hot', 'Flushing']",1,PFIZER\BIONTECH,IM 923902,ME,47.0,F,"Chest tightness, flushing, arm tingling, lip swelling, warmth No shortness or breath, no chest pain, no palpitations, no tongue swelling, no rash, no redness, no nausea, vomiting or lightheadedness, no diaphoresis, no Hives improved in 1 hour and with Benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,Cosentyx,none,psoriatic arthritis,,"iodine, tree nuts","['Chest discomfort', 'Feeling hot', 'Flushing', 'Lip swelling', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 923903,KS,40.0,F,Nause and headaches started 05 JAN 1021 around 5:00 pm. On 06 JAN 2021 I start experience dizziness and vomit.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,MIL,Vit D,None,Antithrombin III Deficiency,"Headaches, nausea, dizziness and vomit",Toradol,"['Dizziness', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,SYR 923904,FL,33.0,F,I developed congestion and nasal burning. Loss sense of smell and taste. Headache and muscle aches. I went to medical facility for a COVID19 test on the morning of 12/31/2020. I ended up testing Positive for COVID19.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/31/2020,10.0,PVT,Adderall,None,None,,Penicillin,"['Ageusia', 'Anosmia', 'COVID-19', 'Headache', 'Myalgia', 'Nasal discomfort', 'Respiratory tract congestion', 'SARS-CoV-2 antibody test positive']",1,PFIZER\BIONTECH,IM 923905,TX,72.0,F,"Tiredness, Headache, Feeling Nauseated, Dizziness,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PVT,"Trulicity, Glimepride, Levothyroxin, Losartan, Xalaton, Combigan, Vitami D3, Magnasium, One a day Vitamin",None,Diabetic,,None,"['Dizziness', 'Fatigue', 'Headache', 'Nausea']",1,MODERNA,SYR 923906,KS,26.0,M,2 days after receiving vaccine patient developed hives and itching. Treated with OTC diphenhydramine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/25/2020,2.0,PVT,Montelukast Loratadine,None,Seasonal allergies Exercise induced asthma,,None,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 923908,GA,61.0,F,"Low grade temp, body aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,"Ibuprofen, Vit D, Eye supplements, Valtrex ,",none,degenerative disc disease,,"Tetracylin, IVP dye","['Fatigue', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 923909,FL,72.0,F,Swollen lymph node on right jawline,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/05/2021,4.0,PUB,"Atorvastatin, gabapentin , tylenolPm, melatonin, linzess",None,"Hunner?s lesions in my bladder, IBS",,None,['Lymphadenopathy'],1,MODERNA,SYR 923911,MO,51.0,F,"Since getting the vaccine, my arm has had many different reactions. It did start out with pain at the injection site, swollen and red. That went away. Last week, the red spot around the injection site seemed to spread to the size of a golf ball. Last night, I noticed that there was a white ring around the injection site and the redness spread to the size of my hand, puffed up and looked like a rash. Did not hurt or itch, just warm to touch. This morning, It was not puffed up, no white ring, but the redness is still the size of my hand and warm to touch. It comes and goes as far as the swelling, rash look, I also had swelling under my right armpit which is the arm I had the shot in. The swelling is down today. Not sure if this is anything to worry about, please let me know if I need to do something. I do take Benadryl for my allergies, so that may be helping some of the symptoms lessen.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/23/2020,0.0,PVT,,,,,Percocet/Percodan Morphine Seasonal,"['Injection site discolouration', 'Injection site erythema', 'Injection site pain', 'Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Skin swelling']",1,MODERNA, 923912,NC,26.0,F,I had joint pain and muscle aches. I had a headache also. My expected date of delivery is 06/19/2021. I am 16 1/2 weeks today.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,UNK,I take prenatal vitamins.,No,No,,I am allergic to sulphur,"['Arthralgia', 'Exposure during pregnancy', 'Headache', 'Myalgia']",1,MODERNA,IM 923913,WI,16.0,F,Patient was given the immunization despite her being outside of the appropriate age range. Patient and workplace had signed VAR stating they were 18 years old and able to receive the vaccine. Immunizing staff wasn't aware of her age due to the fact that the VAR was filled out and approved by the workplace.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,SEN,,,,,,['Product administered to patient of inappropriate age'],1,MODERNA,IM 923914,MD,31.0,F,"Around bedtime on the day of injection, developed a fever of 99.8 and a terrible headache. My left arm was very painful, even when not touching it or moving it. When I woke up in the morning, fever was higher (100.7) and I was so weak I could barely walk to the bathroom. I felt very dizzy and tired. I drank water and took ibuprofen for the pain. Stayed on the couch all day and took ibuprofen PM to sleep last night. Woke up very early today with a fever of 99.4 and still a bad headache and weak. Walking to the bathroom makes me feel like I need a nap.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PUB,Multi vitamin Zyrtec,None,None,,Pollen,"['Asthenia', 'Dizziness', 'Fatigue', 'Gait disturbance', 'Headache', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 923916,NJ,36.0,M,"Vaccine recipient received second shot of Pfizer-BioNTech vaccine on 1/4/2021. Reported that starting approximately 24 hours post vaccine developed a low grade fever (99.1), body aches, chills, headache, and malaise. Vaccine recipient took Tylenol. This morning they reported that most of their symptoms have subsided and an occasional headache remains. Pfizer-BioNTech COVID- 19 Vaccine EUA.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,"Multivitamin, Zyrtec, Biotin",None,None,Patient reported headache after getting initial Pfizer-BioNTech COVID-19 vaccine on 12/15/2020. Age 36.,Seasonal allergies,"['Chills', 'Headache', 'Malaise', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 923917,VA,63.0,F,Got the Moderna COVID-19 Vaccine EUA on 12/28/2020 around 3:48pm. in my left arm. Arm was sore for about 3 days afterwards. Swelling and redness was noticed on 12/30/2020 and has not gone away. Still have redness and swelling and skin feel still feels swollen and warm around the injection site. Also have tightness or hardness around the injection site and itches.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,"atorvastatin,synthroid,metropolol, hydrochlorazide.(not sure how to spell this)",none,have some arthritis in hands and feet,,"penicillin, poison ivy leaves and sap, shellfish called conch","['Erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity', 'Peripheral swelling', 'Skin tightness']",1,MODERNA,IM 923918,MD,67.0,M,"fever 101, chills, head ache,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,WRK,unknown,denied,Diabetic,,unknown,"['Chills', 'Headache', 'Pyrexia']",1,MODERNA,IM 923919,PA,19.0,F,"Hypotensive - 106/62, 98/57; Lightheadedness; Flushed Monitored for 35 minutes total Placed in Trendelenberg position. BP 121/74. HR 85 Released from clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,unknown,unknown,unknown,,Trazodone - Headaches Clonidine - Dizziness / Lightheadedness,"['Dizziness', 'Flushing', 'Hypotension']",1,PFIZER\BIONTECH,IM 923921,MA,57.0,F,"Pt reported a slightly scratchy throat, feeling a little ""tightness"" without difficulty swallowing Denies SOB, CP, rash. No improvement after 5-10 minutes, seen by AMR EMT for physical assessment. VSS: SpO2 100%, 96 HR, BP 157/107 Per EMS, lung sounds clear no wheezes noted. No hives noted on physical assessment Left building approx 1815, steady gait A&Ox3",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,,,,,"PCN, Sulfa, Cipro","['Oropharyngeal discomfort', 'Throat tightness']",1,MODERNA,IM 923922,MO,49.0,F,"A rash on the upper right arm (which is the same arm I received the vaccine). Rash is slightly raised and slightly warmer than surrounding skin, but does not itch.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,01/05/2021,12.0,PVT,,,,,,"['Feeling hot', 'Rash', 'Rash papular']",1,MODERNA,IM 923923,NY,61.0,F,"8 days post injection (Wed. 12/30/20), L arm became red, swollen and warm to touch. Saw internal medicine doctor (Thurs 12/31/20) recommended to take Zyrtec- took one and on Friday 1/1 the red (not raised area) was fading. By today 1/6/20 it has resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/30/2020,8.0,PVT,"Vitamen C 500 mg q day, Zinc 50 mg q day.",None,None,,No known drug or food allergies.,"['Erythema', 'Peripheral swelling', 'Skin warm']",1,MODERNA,IM 923924,TX,42.0,F,"Injection side is swollen, red, itchy, burning, and hot. appt set for Friday for PCP",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2000,01/06/2021,7312.0,PVT,"Synthroid, Escitalopram, Vitamin D Excedrine",,"hypothyroidism, obesity",,"Vicodin, Imitrex","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 923925,NY,54.0,F,"About 30 to 40 mins after receiving vaccine i began to experience acute rapid heart beat, extreme heat or hot flash, shaking, almost hyperventilating but was able to control breathing. Episode lasted 10 mins Immediately with vaccine I noted an antiseptic taste in my mouth and this continues.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,Levoxyl Vitamin d Multi vitamin,None,Hypothyroidism Lyme titer,,None,"['Feeling hot', 'Heart rate increased', 'Hot flush', 'Hyperventilation', 'Immediate post-injection reaction', 'Taste disorder', 'Tremor']",1,PFIZER\BIONTECH,SYR 923926,OK,21.0,F,"Chills, fever up to 102.5, and aches. Alternating ibuprofen and Tylenol lowered the fever to 100 but weren?t able to break the fever for over 12 hours. Temperature is continuing to drop back to normal range now.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,Topamax 50 mg twice daily Iron 65 mg Prenatal vitamin 200 mg Omeprazole 40 mg twice daily Sprintec,,GERD and migraines.,,Oxycodone causes a rash.,"['Chills', 'Pain', 'Pyrexia']",1,MODERNA,SYR 923927,MD,58.0,F,"On day 8 following vaccine and large area of redness appeared on left deltoid spreading from injection site down and inward. Area is very firm, red, swollen, painful, and itches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,WRK,"Metformin 500mg BID; spironolactone 25mg QD; Atorvastatin 20mg QD; Vitamin D3 2,000ui QD; Vitamin C 500mg QD; Qunol Co-Q-10 daily; Zyrtec; Magnesium 500mg daily; Zinc; Vitamin A",none,Diabetes type 2; Asthma,,Lisinopril and Codeine,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 923928,MO,44.0,F,"I received the Covid Vaccine on 12-22-2020 in my left arm. I did have some soreness & body aches for a couple days after the vaccine was given. On Friday Jan 1, 2021 I noticed my left arn was very warm and tender at injection site. On Saturday Jan 2, 2021 my left arm started itching, became red and very hot to the touch. Today is Tuesday Jan 5, 2021, my arm is still very hot to the touch, very itchy and the redness has increased to most of my upper arm. Visible irritation noted to the left arm. I did check in with employee health.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,01/01/2021,10.0,PVT,,,,,Sulfa Drugs,"['Injection site irritation', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Pain']",1,MODERNA,IM 923929,ME,44.0,F,"fogginess, headache, sinus pressure no other symptoms improved water and observation",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Cymbalta, Depakote, Detrol, metoprolol, Lisinopril, Adderall, singular, albuterol. flovent, omeprazole",none,"asthma, depression, HTN, GERD",,"Demerol, guaifenesin, sulfa, naficilin, aspartame","['Feeling abnormal', 'Headache', 'Paranasal sinus discomfort']",1,MODERNA,IM 923930,TX,44.0,F,"Symptoms - ? EE reports she waited for 30-minute observation period with no adverse reaction. EE left work to drive home after vaccine and reports approximately 45 minutes later felt ?hot and cold? all over her body and felt ?panicky.? EE reports she pulled over and called her husband. At time of call (approx. 13:33), EE reports still feeling a little ?tingly? on her entire body and ?odd.? EE reports mild shaking to bilateral hands. EE reports last time she ate was at approximately 06:45 this am. Home remedies? - EE was in Starbucks parking lot at time of call and was going to be getting lunch after call. Recommendation? EE educated to eat and drink something, EE verbalized back understanding. EE educated to call vaccine support line for worsening symptoms, EE verbalized back understanding and denied further questions at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Feeling of body temperature change', 'Panic reaction', 'Paraesthesia', 'Tremor']",2,PFIZER\BIONTECH,IM 923931,FL,37.0,F,"Severe fatigue, headache, chills, vomiting, tachycardia for 4 days that started the morning after I received my vaccine. I could not hold my head up or hold down fluids. Saw an NP at urgent care and was given zofran. Covid and Flu test were negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,None,Strep throat,Asthma,,Codeine,"['Chills', 'Fatigue', 'Fluid intake reduced', 'Headache', 'Influenza virus test negative', 'SARS-CoV-2 test negative', 'Tachycardia', 'Vomiting']",1,MODERNA,IM 923932,IN,79.0,U,"Patient had chills, nausea, and vomited x3 about an hour post vaccination. Patient was given Zofran 4mg PO. Symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Chills', 'Nausea', 'Vomiting']",1,MODERNA,IM 923933,WV,29.0,F,"On 1/3/2021 I noticed tenderness at injection site, there was a knot under the skin, on 1/5/2021 the was a red circle around injection site, this area welted up but welting goes away and comes back and is itchy at times, on 1/6/2021 red area is lighter in color, continues to welt up off and on and is itchy at times.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/03/2021,10.0,SEN,Labetalol,None,Hypertension,,NKA,"['Injection site nodule', 'Injection site pain', 'Injection site urticaria', 'Pruritus', 'Urticaria']",UNK,MODERNA,IM 923934,MD,61.0,F,I experienced a metallic taste in my mouth about a minute after receiving the vaccine. It lingered for approximately six hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Crestor 20 mg, Vit D3 2000 iU, multivitamin - all taken the night before No medications of any type were taken this morning",None,Pacemaker for bradycardia and syncopal events - since 2002,,"Morphine, poppy seeds, pineapple",['Dysgeusia'],1,PFIZER\BIONTECH,SYR 923935,MA,62.0,F,"I got my shot on the 19th and that evening it was like a light switch and I was so tired I went to sleep at 730pm I had severe chills and fever and had to go to bed. The next day I still wasn't feeling well and I was called in to get covid tested and I went to the ER on the 21st and took a rapid covid test that was positive. I was stable and had good oxygenation and was discharged. I have fever nausea vomiting I also had problems with O2 stat i was in the 80s and realized I was having respiratory failure so I was admitted on the 27th and I've been here ever since. I had kinetic storm and infusions my O2 stats were bad and I was sent to the covid unit and put on high flow oxygen and negative for a PE, I'm still on the covid unit but I feel much better today",Not Reported,,Not Reported,Yes,11.0,Not Reported,N,12/19/2020,12/19/2020,0.0,PVT,tylenol for arthritis,none,arthritis,fever and chills post shingles shot,"morphine, erythromycin, IV iron","['Chills', 'Cytokine storm', 'Fatigue', 'Malaise', 'Nausea', 'Oxygen saturation abnormal', 'Pyrexia', 'Respiratory failure', 'SARS-CoV-2 test positive', 'Vomiting']",1,PFIZER\BIONTECH,SYR 923936,ME,49.0,F,"Initially patient was told to take Benadryl and ibuprofen for injection site reaction pain. In the following days patient has developed urticarial plaque has continued to increase in size since injection (currently 4-6?); pruritic and hot to the touch; feverish since injection; diffuse arthralgias and myalgias; unable to lift left arm due to pain for approximately 3 days; pain continues in arm. Continues to feel poorly, has headache and lethargy. Developed dysuria, hematuria and lower abdominal pain (1/2/21). Experiencing runs of tachycardia in evenings lasting seconds to minutes and then resolve.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,,,,,,"['Abdominal pain lower', 'Arthralgia', 'Feeling abnormal', 'Injected limb mobility decreased', 'Injection site pain', 'Myalgia', 'Pain in extremity', 'Pruritus', 'Pyrexia', 'Skin warm', 'Tachycardia', 'Urticaria']",1,MODERNA,IM 923937,TX,45.0,F,"Patient received the vaccine in her arm. Then at the 12 min mark, she felt her lips tingling, dry mouth, light headed, flushed, and nauseated. She was taken to the Emergency Dept where she was given a Zofran and still vomited once. Then she got a Benadryl and Solumedrol injections. Then she was observed for an hour and a half. Her temp did go up to 99.2 from around 98.4. HR 90-100s. O2 sats normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Wellbutrin 150 Daily, Multivitamin, Claritin.",None,"Diastolic heart failure, chronic vertigo, seasonal allergies.",,"Penicillin, Sulfa, Ambien, Watermelon, Bactrim.","['Body temperature increased', 'Dizziness', 'Dry mouth', 'Flushing', 'Heart rate increased', 'Immediate post-injection reaction', 'Nausea', 'Oxygen saturation', 'Paraesthesia oral', 'Vomiting']",1,MODERNA,IM 923938,FL,45.0,F,"I was completely fine for 7 days after the shot, then on the 8th day I started to get a red rash on the site of the shot on my left upper arm, swollen, and the muscles going up to my shoulder and neck started to swell and painful (painful to lift my arm up). For the past 2 days the swelling and rash has doubled in size (grown to 3.5inches in diameter), fatigue, nausea, dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/04/2021,8.0,WRK,HCTZ Methy B complex Zinc,none,Auto-immune disorder (MCTD) and MTHFR,,none,"['Condition aggravated', 'Dizziness', 'Fatigue', 'Injection site erythema', 'Injection site rash', 'Muscle swelling', 'Myalgia', 'Nausea', 'Pain']",1,MODERNA,SYR 923939,CT,72.0,F,"on January 5, I noted a 2-2 1/2 reddened area on my left arm at the injection site. This was 2 weeks after the initial injection. The area was not hot to touch but was mildly itchy. The area has begun to slowly fade.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/05/2021,13.0,PUB,Synthroid,none,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 923940,FL,74.0,F,"tinnutis, About 29 hours after my first dose, it began to sound like water running in my right ear. Then on the 6th day after my first vaccine, the same sound began in my left ear. This is the 7th day after my first dose and the sound continues continuously in both ears. Hearing was reduced",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,No prescriptions Caltrate Areds Ieye vitamin Vitamin D3 magnesium St. Joseph's 81 mg aspirin Biotin,gastroenteritis,None,,allergic to penicillin,"['Hypoacusis', 'Otic examination normal', 'Tinnitus']",1,MODERNA,SYR 923941,,20.0,F,"One week after my shot my arm had became itchy and red. Now it is not itchy, but it is red and the swelling spot has grown from a small mosquito bite size to the size of my palm. Very warm to the touch and my right arm is sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/05/2021,7.0,SEN,Birth Control- Syeda,,,,,"['Erythema', 'Pain in extremity', 'Pruritus', 'Skin warm', 'Swelling']",UNK,MODERNA, 923942,TX,33.0,F,The effect I had was extreme fatigue day after the vaccine. I couldn't stay awake until my regular bed time. This continued for 3 days I had to go to bed super early. The following Sunday I started feeling better.(Estimated date of delivery mid Sept. Pt stated she isn't moving forward with pregnancy).,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Levothyroxine 75 mcg, Zantac .5(as needed basis),omeprazole 20 mg(as needed basis), Albuterol inhaler (as needed basis)",,Hypothyroidism over 20 years,,No,"['Fatigue', 'Somnolence']",1,PFIZER\BIONTECH,IM 923943,PA,53.0,F,Dizziness Lightheadedness Nausea Monitored for 30 minutes total; no intervention required and released to home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,unknown,unknown,unknown,,Oxymetazoline Nasal Spray,"['Dizziness', 'Nausea']",1,PFIZER\BIONTECH,IM 923944,FL,52.0,F,"Silver Dollar size persistent induration, erythema and itching 9 days after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,MIL,,,,,,"['Erythema', 'Induration', 'Pruritus']",1,MODERNA,IM 923945,,42.0,M,Diarrhea and Headache starting 3 hours after first dose.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/23/2020,0.0,UNK,,,,,,"['Diarrhoea', 'Headache']",UNK,PFIZER\BIONTECH, 923946,CA,62.0,F,"Started with body aches and lethargy at about 1800, then progressed to temperature sensitivity-felt cold. I went to bed but awoke hot, then alternated with cold frequently. I began having twitching in my hands which kept me awake. These symptoms continued until morning. Toward the AM, about 0500, I had fluttering sensations in my body.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,"Vitamin C, Multivitamin, Magnesium, B12",none,none,"age 61,Oct. 2020, Shingles, sore arm/aching",NKA,"['Feeling of body temperature change', 'Lethargy', 'Muscle twitching', 'Pain']",UNK,MODERNA,IM 923947,AZ,54.0,U,"Red rash around site, slight swelling and some itchiness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PUB,None,None,None,,None,"['Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Rash erythematous']",1,MODERNA,IM 923948,IN,39.0,F,"Patient has hx of anxiety, states she usually takes 0.5 mg, took only 1/2 prior to vaccine clinic. After scheduling return visit, patient sat down and shortly c/o having problems breathing. Line monitor noticed patient and called APRN and EMS. Patient placed in WC and brought to a room. VS monitored, patient called and spoke to husband and after about 30 mi she left. VS normal, no SOB, calmed own.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,"Xanax, Metformin","DM, Anxiety","DM, Anxiety, morbid obesity",,Ibuprofen,['Dyspnoea'],1,MODERNA,IM 923949,CA,28.0,F,Mild rash- anterior neck and left forearm associated with skin tingling; resolved within 15 minutes with Benadryl 25 mg po x 1 dose,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Hydroxyzine, Benadryl prn for eczema",No,Eczema,,Amoxicillin,"['Rash', 'Skin tightness']",1,MODERNA,IM 923950,MO,36.0,F,Day of injection developed a nickel sized raised bump at injection site. 1 week after this red area began enlarging; did not start subsiding until 1/5/2021. See photo taken 1/3/2021: perimeter was red and raised. Itching started on 1/4/2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/22/2020,0.0,PVT,,,,,mushrooms penicillin,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 923951,IN,65.0,F,"Fever, chills, headache, nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,None,,,,"Codiene, latex","['Chills', 'Headache', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH, 923952,TX,45.0,F,"Patient had tingling around her mouth, lightheadedness, flushed. She went to the ER and they gave her Zofran and she vomited. She had Benadryl and was observed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Wellbutrin 150 Daily, Multivitamin, Claritin.",None,"Diastolic heart failure, chronic vertigo, seasonal allergies.",,"Penicillin, Sulfa, Ambien, Watermelon, Bactrim.","['Dizziness', 'Flushing', 'Paraesthesia', 'Vomiting']",1,MODERNA,IM 923953,IL,38.0,F,"Red, raised, swollen pain at injection site starting from 24 hours post injection and still remaining 7 days post injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,None,None,None,,"Penicillin, sulfa","['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 923954,IL,65.0,F,Sugar levels became abnormally high. Over 400. Insulin given to bring level back to correct level but took all afternoon and evening to get it down.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,SEN,"Novolog, Trulicity, Synthroid, linezz, venlafaxine, citracal, prevegen, atorvastin, bupropion, oxybutrin, mrybetiq, Colace,",none,Diabetes since 1957,"Zoster vaccine age 55 or so. Red, hot rash, area at injection site",none known,"['Blood glucose increased', 'Increased insulin requirement']",1,PFIZER\BIONTECH,IM 923955,MA,35.0,M,"Patient reports receiving the Moderna COVID-19 vaccine 12/28/20, started noticing itching to left proximal arm with subsequent rash developing to arm 48 hours ago. Patient reports lining rash last night, noted rash extending past lining today. Patient noted some reactive lymphadenopathy, denies any further concerns or complaints.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,PVT,None,None,History of Tourette's,,Penicillin,"['Condition aggravated', 'Lymphadenopathy', 'Pruritus', 'Rash']",1,MODERNA,IM 923956,KY,42.0,F,Fever 101.4. Headache body aches diarrhea ongoing for 3 days now,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PVT,Losartan. Lexapro. Protonix,None,None,,None,"['Diarrhoea', 'Headache', 'Influenza virus test', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,MODERNA,IM 923957,AL,64.0,F,"body aches, fever 1st 24 hrs, diahrea, headache 48 hrs and swelling of eyes, nasal passages and shortness of breath at 50hrs. Treated with antihistines and steroids for a week .Feeling better now but have been extra tired.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,"lisinopril. levothyroxine, omeprazole,farxiga, metformin, hctz, multivitimin",,"GERD, HTN, diabetes, hypothyroid",,"penicillin , lavender, seasonal allergies","['Diarrhoea', 'Dyspnoea', 'Eye swelling', 'Fatigue', 'Headache', 'Nasal congestion', 'Pain', 'Pyrexia']",1,MODERNA,IM 923958,MO,30.0,F,"The injection site developed a large bruise. Then a few days later the injection site and the 1-1.5 inches around the site became red, inflamed/swollen, hard to the touch and painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/25/2020,3.0,PVT,,,,,Keflex Augmentin Bee Stings,"['Injection site bruising', 'Injection site erythema', 'Injection site haemorrhage', 'Injection site induration', 'Injection site inflammation', 'Injection site pain', 'Injection site swelling']",UNK,MODERNA,IM 923959,IN,59.0,F,"6:15 pm Chilling, cold to touch, afebrile. 10 pm woke up still chilling afebrile. Swelling in right axilla. Tightness around upper arm/axilla area. No redness at injection site. 5 am weakness in lower legs, shakey/jittery, and dizziness. Bp 129/75, HR 65, resp 16, O2 say 96. 9 am dizziness subsided 11 am weakness in legs subsided, axilla swelling subsided, soreness remains.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,None,None,Stage 3a kidney disease,,None,"['Chills', 'Dizziness', 'Feeling jittery', 'Muscular weakness', 'Oedema peripheral', 'Pain', 'Peripheral coldness', 'Skin tightness', 'Tremor']",2,PFIZER\BIONTECH,IM 923960,TX,47.0,F,"1255 states that feels palpitations , tingling , shaking hands and light headed . VS BP 142/78, HR 108, R 18 SPO2 99% on room air. 1306 : Denies palpitations and shaking hand, BP 138/72 , HR 80 , Spo2 100 on room air, R 17 1315 ; Denies any of the symptoms. 1330: check out vitals at the time of check out VS BP 136/72, HR 72, R 17, SPO2 99% on room air.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,"Synthroid, Adderall and birth control, Plaquenil",None,Rheumatoid arthritis,,None,"['Dizziness', 'Palpitations', 'Paraesthesia', 'Tremor']",1,MODERNA,IM 923961,MI,46.0,F,"About 10 minutes after I received the ?Moderna COVID-19 vaccine EUA? I felt lightheaded and my heart started to race. This only lasted for approximately a minute. I sat and waited for about 30 minutes before I left. When I got into my vehicle I noticed that my chest was really tight and I called my husband to talk to me while I drove home. After arriving home and not feeling like my chest tightness was a normal symptom I called my daughter who is an RN and she checked my vitals which were fine. She told me that I should continue to self monitor and if I got any worse to go to the ER. My symptoms chest tightness did not get any worse and felt a little better by the time I went to bed between 10-11pm. The next morning I woke up to get ready for work and felt a lot of the common symptoms like: Fatigue, headache, muscle pain, chills, fever, and my arm was sore. The highest fever that I recorded was 102.4. I still have a fever as I am filling out this form. It is 100.2 and I took 2 Motrin an hour and a half ago.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PUB,Zyrtec,No but I tested positive for Covid-19 on 10/25/2020.,Asthma and my sense of taste/smell hasn?t fully returned from Having Covid-19.,,"Allergic to Bactrim, chemical sensitivities and I have several environmental allergies, (trees, dust, dogs.)","['Chest discomfort', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Pain in extremity', 'Palpitations', 'Pyrexia']",1,MODERNA,SYR 923963,CA,60.0,M,"Low grade fever,Chills, muscle and joint pain. No treatment required. Symptoms resolved on 01/06/21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,Turmeric capsules,None,None,,None,"['Arthralgia', 'Chills', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 923964,NY,37.0,M,"Itchiness, redness, blotchy arms",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,,,Asthma,,,"['Erythema', 'Pruritus', 'Rash macular']",1,MODERNA,IM 923965,NJ,32.0,F,Vaccine recipient received vaccine on 1/5/2021. Within 24 hours they developed right arm soreness and describes arm as feeling heavy. At night they became sweaty and feverish. They took Tylenol. This morning reported that arm was still sore/heavy and they have a headache.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,None,None,None,,None,"['Headache', 'Hyperhidrosis', 'Limb discomfort', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 923966,OH,78.0,F,"from about 9 p m on 01/04/2021 to 10 a m on 01/05/2021 I felt very sick with headache, sore throat and All-over aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,Premarin vaginal cr Calcium Magnesium & Zinc supplement Juice Plus Omega Blend supplement Hair Volume Biopectin Apple extract,No,No,,No,"['Headache', 'Malaise', 'Oropharyngeal pain', 'Pain']",UNK,PFIZER\BIONTECH, 923967,AZ,54.0,F,"Red rash, mild swelling at injection site, and some itchiness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PUB,,,,,,"['Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Rash erythematous']",1,MODERNA,IM 923968,ME,39.0,F,"Palpitations and tachycardia up to 120, elevated BP to 150/80 No other symptoms resolved within 30 minutes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,none,none,none,,flu vaccine question anaphylaxis in the past,"['Blood pressure increased', 'Palpitations', 'Tachycardia']",1,MODERNA,IM 923969,TX,36.0,F,"1/3/2021 VACCINATION. BY 6PM, HA. CHILLS AND SHAKING CAME OVER NIGHT. TEMP O F 100.03, TOPPED OUT AT 100.6. 1/4/2021 ABDOMINAL CRAMPING/DIARRHEA. CONVERSED WITH MEDICAL STAFF AND DETERMINED THAT COVID ANTIBODIES HAD A DUAL RESPONSE TO COVID AND LEARNING IT. 36 HOUR AFTER, FEEL BACK TO NORMAL. *FEEL THAT THIS WAS NOT A DIRECT ADVERSE REACTION TO THE VACCINE, RATHER IMMUNE RESPONSE TO RECENT BOUT WITH COVID.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,"CYNTHROID, IRON SUPPLEMENTS; MULTIVITAMIN; OMEGA 3; COLLAGEN",COVID 12/2020; CLEARED ON 12/21/2020,BACK PAIN/ MUSCULAR,,,"['Abdominal pain', 'Body temperature increased', 'Chills', 'Diarrhoea', 'Headache', 'Immune-mediated adverse reaction', 'Tremor']",1,MODERNA,SYR 923970,IL,46.0,F,"Woke up with my arm itching. The injection site was swollen, red, warm, and tingly. It is the size of a 2 inch circle. I took 2 zyrtec and went to work. Called pharmacy and they said to report to VAERs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,OTH,"Levothyroxine, spironolactone, & wellbutrin",Stomach flu on Dec. 26--GI symptoms,none hypothroid diagnosed Nov. 2018,,Sulfa,"['Injection site erythema', 'Injection site paraesthesia', 'Injection site swelling', 'Injection site warmth', 'Pruritus']",1,MODERNA,IM 923971,NV,29.0,F,"Tachycardia, palpitations, flushing, and dizziness 1-2 hours after the vaccination administration. Has persisted since.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,"Zoloft 200 mg qhs, Quetapine 50-100 my qhs, Norethidrone. 35 mg qhs, Mobic 15 mg prn daily, Clonazepam 0.5 mg prn daily, Claritin, Ibuprofen",Covid November 8th Flu shot December 4th,Depression and Post partum depression Anxiety,,"Penicillin, ""myacin"" antibiotics, soy","['Dizziness', 'Electrocardiogram abnormal', 'Flushing', 'Palpitations', 'Sinus tachycardia']",1,PFIZER\BIONTECH,IM 923972,NM,52.0,F,"Day of Vaccine I had a low grade fever, Injection spot red with little dots, hot to the touch, headache, sleepiness. This went on for 3 days. On Jan. 1, 2021 I started to feel like I was just getting a cold. Took some cold medicine for 3 days. But since Jan. 1 all I want to do is SLEEP. I did not get out of bed for 3 days. I now get up and do what I have to do, but then I have to go take a nap. I sleep for about 2 to 3 hours then get up and do what I need to then back to bed. All I want to do is SLEEP!!! I have gone to see my Doctor and he is telling me that it has to do with the Vaccine. He could not find anything wrong with me.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,PHM,"Omeprazole 20 mg, Zeta 10mg, Clonazepan 2mg, Lisinopril 10mg, Simvastatin 20mg, Lisinopril 10mg, Metoprolol 25mg, Vitamin D 50,000mg, Potassium 99mg.",,"History of Leukemia. in remission for 35 years, Heart weakness",,"Latex, Vicodin, All Melons, Kiwi, Avocado, Pecans","['Headache', 'Injection site abscess', 'Injection site discolouration', 'Injection site warmth', 'Malaise', 'Nasopharyngitis', 'Pyrexia', 'Somnolence']",1,MODERNA,SYR 923973,PA,38.0,F,Mild Headache; Flushing; Nausea Monitored for 35 mintes Symptoms resolved prior to being released to home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,Unknown,Unknown,unknown,,Bactrim Vancomycin,"['Flushing', 'Headache', 'Nausea']",1,PFIZER\BIONTECH,IM 923974,CT,48.0,F,"Burning sensation center chest approximately 25 minutes after injection. Also exhausted until next day...falling asleep in ER, in car on the way home, then slept from 6:30 pm until 5:40 am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,MIL,"Lexapro, Advair, Meloxicam, Singulair","Sinus pain, headache....Negative COVID","Asthma, osteoarthritis with inflammatory component",,"Dust, codeine","['Chest X-ray', 'Chest pain', 'Electrocardiogram', 'Fatigue', 'Hypersomnia', 'Laboratory test', 'Troponin']",1,MODERNA,IM 923975,IN,50.0,F,"Had welt at injection site the size of golf ball with redness spreading from site out about the size of a baseball. Site itched, redness with heat coming out of site for several days. Arm soreness for 5-6 days afterwards. Injection give on 12/22/2020 and today 1/6/2021 there still is soreness at injection site and slight redness of the area.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,None,None,None,,NKA,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site warmth', 'Pain in extremity', 'Urticaria']",1,PFIZER\BIONTECH,SYR 923976,GA,55.0,F,"Arm red, swollen and bruised at injection site (Day 2-7) Remains red, slightly swollen, bruise improving but now has a red raised welts/bumps at/around insertion site. (Day 8)",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/31/2020,2.0,PVT,none,none,none,,"Shellfish/seafood allergy (this is NOT an anaphylaxis reaction, it is gastrointestinal reaction with vomiting and diarrhea).","['Injection site bruising', 'Injection site erythema', 'Injection site rash', 'Injection site swelling', 'Rash erythematous', 'Rash papular', 'Urticaria']",1,MODERNA,IM 923977,NY,48.0,F,"I got the vacine today. Unfortunately I did have a reaction, and had to cancel my patient load at work for the day. They said if you have food allergies you might have one, but I was willing to risk it. They observed me for 30 min after. After 15 min it felt like I was having a mild panick attack, but I?m used to that so I just breathed through it. Coughed a few times. After 30 min got up and was whoozy/dizzy, but shrugged it off, got my card and walked slowly to my car, drove 5 min home. By then my hands were shaking hard. It was like being shot with a crapload of adrenaline. I called my sister and when I talked I started sobbing. I don?t know, I just couldn?t stop. But I knew it was just the adrenaline and if I could calm down, I?d get thru it. She was awesome bc she kept her voice soft and low when she spoke, which helps. After 3 hours it has calmed down and I?m just really cold and exhausted and nauseous and only a little shaky. Being quiet and calm is helping. Also sitting on a heating pad bc it?s 74 in my apartment and I?m freezing cold. I?ll be ok by end of day. I got the Moderna vacine and I?m still glad I did and thankful I could get it....but to those who are getting it...symptoms are that it feels like being shot full of adrenaline, you get a panic attack, but my O2 actually went up, not down. Chest pain, panting, high anxiety, shaking, nausea, dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Nifedipine, Losartan, Hawthorne berry, multivitamin, albuterol sulfate for nebulizer",Asthma,"Asthma, high blood pressure",,"Dairy, gluten, latex, bleach, mold, dust, pet dander","['Anxiety', 'Balance disorder', 'Chest pain', 'Cough', 'Crying', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Feeling cold', 'Impaired work ability', 'Nausea', 'Panic attack', 'Respiratory rate increased', 'Tremor']",1,MODERNA,SYR 923978,KS,36.0,F,"Chest pain, dizziness, lightheadedness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Chest pain', 'Dizziness']",1,PFIZER\BIONTECH,IM 923979,NY,37.0,M,Red rash 1 hr p inj Pfizer vaccine Immuniazation #1. Improved and recuured 1 hr later Recd IM Benadryl,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,Klonaxepin,,,,bee stings,['Rash erythematous'],UNK,PFIZER\BIONTECH,IM 923980,GA,46.0,F,"Pt state ""about 30 minutes after receiving the vaccine I started having a metal taste in my mouth. About an hour later I started having tingling in my tongue, throat, and, hands. Then I started having head and hands shaking around the same time. About 1 1/2 hours later I started having a burning sensation in roof of mouth then front side of teeth, tonsils, and gum area. These areas turned red. I did not go to the emergency room and I did not take any Benadryl for this. The upper part of my are where I got the shot it is swollen and hot. This start yesterday and still swollen today. I am still experiencing the head and a little hand shaking today."" Encouraged to call md or go to Emergency Room.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PUB,Lisinopril and Amitriptyline daily,none,Hypertension and depression/anxiety,,"Compazine (side effect ""it twisted my tongue up to my jaw and I had to be put in the hospital."")","['Dysgeusia', 'Head titubation', 'Injection site swelling', 'Injection site warmth', 'Oral discomfort', 'Oral mucosal erythema', 'Paraesthesia', 'Paraesthesia oral', 'Pharyngeal paraesthesia', 'Tremor']",1,MODERNA,IM 923981,CT,72.0,F,"January 3, 2021 noted a 2- 2 1/2 inch red area on my left arm at the injection site. This was 2 weeks since I had the vaccine. Area was not hot to touch but was itchy. Slowly fading",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/05/2021,13.0,PUB,Synthroid,none,none,,none,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 923982,,64.0,F,Moderna COVID-19 Vaccine EUA Rash developed at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,UNK,Synthroid 50 mcg Vitamin D 1000 IU Aspirin 80mg Aleve 200 mg Calcium,,,,Penicillin,['Injection site rash'],1,MODERNA,IM 923983,TX,32.0,F,"Dose two of the Pfizer vaccine lot: ELU140 administered to right arm at 0800 01/04/2021. Symptoms began at 2000 01/04/2021 which are; Fever 101.8, resting heart rate sustaining 140 bpm, right wrist pain and swelling to that joint, right supraclavicular node enlargement, tremors, burning sensation on skin to the entire body, severe headache, weakness, frequent urination, fatigue, eye pain, chills, sweating.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,"Vitamin A,D,K,C,B12, thyroid NP 0.5 gr.",No,None,,"Penicillin, Bees/wasp","['Arthralgia', 'Heart rate increased', 'Joint swelling', 'Pyrexia']",1,PFIZER\BIONTECH, 923984,MI,50.0,F,"Beginning 1/3/2021, patient noted her injection site and surrounding area becoming pink. On 1/4/2021, patient noticed redness at and around injection site measuring roughly 3 inches in diameter. By the next day, the redness has become more prominent and larger. She contacted her primary care physician who felt it was likely a delayed allergic response. 1/6/2021, the redness has become a lighter pink and patient reports the area to be ""markedly improved"" from days previous.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,PUB,unknown,none,eosinophilic esophagitis,,unknown,"['Injection site discolouration', 'Injection site erythema', 'Injection site hypersensitivity']",1,MODERNA,IM 923985,IA,64.0,F,"Woke up on morning of 1/1/2021 with fever of 101 that lasted for 4-5 hours and Tylenol did take the temperature down. Was also nauseated, exhausted, loss of appetite for 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PUB,Unknown,None,unknown,,None,"['Decreased appetite', 'Fatigue', 'Nausea', 'Pyrexia']",1,MODERNA,IM 923987,,40.0,F,LOCAL SITE REACTION - severe itching and nodule,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,UNK,MELATONIN 2 MG BEDTIME,NONE,NONE,,MORPHINE MONOSTAT,"['Nodule', 'Pruritus']",1,MODERNA,IM 923988,,45.0,F,initially started with body aches at 11:00 am on 1/4/2021 and then developed a fever and chills at 4:00 and 5:00 severe body aches with difficulty moving/walking due to pain and also had slight sore throat - best description is I felt like I had been hit by a truck. Napped from 5-6:30 and then to bed at 10:00. Woke up on 1/5/2021 without body aches but continued with slight ichy throat and feeling like the roof of mouth and tongue were burnt. Continuing to feel those symptoms on 1/6/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,OTH,"D3, Probiotic, Glucosamin Chondroitin, Magnesium",COVID 19 11/23/2020,none,,"sulfa, aged cheese, red wine","['Chills', 'Gait disturbance', 'Oral discomfort', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'Throat irritation', 'Tongue discomfort']",1,MODERNA,IM 923989,IN,32.0,M,Lump on base of the left side of neck,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,UNK,Omega-3 supplement Nexium 20 mg,None,None,,codeine,['Neck mass'],UNK,MODERNA,IM 923991,CA,27.0,F,Severe swelling at injection site. Nerve involvement - tingling and numbness in whole arm and extending up to neck. Pain scale 7-8 near injection site. Moderate headache and scratchy throat with mucus. Slowly getting worse (24 hours after injection).,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,Methimazole 10 mg,Graves disease,Graves disease,,nkda,"['Headache', 'Hypoaesthesia', 'Injection site pain', 'Injection site swelling', 'Paraesthesia', 'Throat irritation']",1,MODERNA,IM 923993,NC,62.0,M,"Patient was vaccinated Dec 30, 2020. Prime dose of Moderna vaccine. Observed for full 15 minutes post-injection. No complaints when asked during observation. Released. Subsequently, vaccine clinic staff learned from the patient's supervisor that on Jan 4, 2021 that the patient had expired on Jan 2, 2021. By report from the supervisor, the patient was found dead at his home. The patient's primary care provider was unaware of his death when contacted by this reporter today (Jan 6, 2021). Electronic Medical Record without any information since the vaccination.",Yes,01/02/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,PVT,Unknown,No,History of stage II (T3N0) appendiceal carcinoma - s/p resection Dec 2014. CAD s/p stenting Diabetes Mellitus Hyperlipidemia Hypertension Glaucoma,,Hay fever,['Death'],1,MODERNA,IM 923994,WI,20.0,F,"Shot arm became itchy and small red bump formed. Over the past 24 hours, the bump grew and is still red and warm to the touch. Soreness throughout right arm where I got the shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PHM,Birth Control- Syeda,,,,,"['Erythema', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Skin warm']",UNK,MODERNA, 923995,CA,36.0,F,"Redness, warmth, irritation, inflammation, itchiness, soreness at injection site >1 week post vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,No,None,None,,NKDA,"['Injection site erythema', 'Injection site inflammation', 'Injection site irritation', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA, 923996,TX,45.0,F,"Reaction- nausea/vomiting, flushing, lips tingling, dry mouth, lightheaded (not dizzy though)- onset of symptoms approx. 12 min post injection, temp elevation in ER ER about 1 hr- given ODT Zofran, IM Benadryl and Solumedrol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Multivitamin, Wellbutrin, Claritin",No,Diastolic Heart Failure; Chronic Vertigo; Seasonal Allergies,,"Watermelon, PCN, Sulfa, Ambien","['Body temperature increased', 'Dizziness', 'Dry mouth', 'Flushing', 'Nausea', 'Paraesthesia oral', 'Vomiting']",1,MODERNA,IM 923997,,32.0,F,local erythema,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/04/2021,12.0,WRK,,,,,,['Erythema'],UNK,MODERNA, 923998,MI,34.0,F,"12 hours after vaccination I got a low grade fever of 101. I had severe body back aches that were so severe I had a difficult time walking. My injection site (Left deltoid) was swollen and sore, although not more than usual after receiving a vaccine. I had no headache at all. The major concern was the fever and the backaches. I could not get warm, and I was shaking badly because I was so cold. I had ZERO relief despite taking 700 Mg of Tylenol. Side effects finally subsided after about 5 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,Lexapro 20 mg 1 x per day. Accutane 80 mg 1x per day.,None,None,,Penicillin,"['Back pain', 'Feeling cold', 'Gait disturbance', 'Injection site pain', 'Injection site swelling', 'Pain', 'Pyrexia', 'Tremor']",1,PFIZER\BIONTECH,IM 923999,CA,34.0,M,Complaining of tingling to injection site after 10 minutes. Also complaining of light numbness to left thigh. All symptoms resolved after 20 minutes.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,None,None,None,,Motrin,"['Hypoaesthesia', 'Injection site paraesthesia']",1,MODERNA,IM 924000,NY,44.0,F,Woke up with flu like symptoms 105 fever chills body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,,Surgery for mastectomy reconstruction done 12/22/2020,Fibromyalgia,,Shellfish Penicillin Latex,"['Chills', 'Influenza like illness', 'Pain', 'Pyrexia']",1,MODERNA,SYR 924001,CA,,F,"Patient received the covid vaccine dose #2 on 1/5/2021. She tolerated the vaccinations without problem. She reported that she is very concerned that the second dose of Pfizer vaccine was administer at an ""unusual site"" in her arm where the adipose tissue. She took picture of the injection site. Denies any pain, swelling, redness at the injection site. She is concerned about the efficacy of the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,UNK,,,,,,['Product administered at inappropriate site'],UNK,PFIZER\BIONTECH, 924002,PA,51.0,F,Palpitations reported by patient. 35 minutes monitored Vital Signs within normal limits Symptoms resolved. Released to home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,unknown,Unknown,Unknown,,Not on file,['Palpitations'],1,PFIZER\BIONTECH,IM 924003,MI,34.0,F,"Numbness in mouth lasting more than 5 hours now, no musculature involvement",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,,"Migraine with aura (sensory aura, usually one side of mouth goes numb)","Migraine with aura (sensory aura, usually one side of mouth goes numb)",,,"['Condition aggravated', 'Hypoaesthesia oral']",1,PFIZER\BIONTECH,IM 924004,OH,40.0,F,"Pain at injection site that persisted followed by numbness and tingling down medial aspect of arm for approximately 24 hours after the injection, upper extremity and neck ache, headache with associated eye pain, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,WRK,None,None,None,,"Sulfa drugs, amoxicillin, ibuprofen","['Eye pain', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Injection site pain', 'Neck pain', 'Pain in extremity', 'Paraesthesia']",1,MODERNA,IM 924005,TX,45.0,F,"Reaction- nausea/vomiting, flushing, lips tingling, dry mouth, lightheaded (not dizzy though)- onset of symptoms approx. 12 min post injection, temp elevation in ER ER about 1 hr- given ODT Zofran, IM Benadryl and Solumedrol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Multivitamin, Wellbutrin, Claritin",No,Diastolic Heart Failure; Chronic Vertigo; Seasonal Allergies,,"Watermelon, PCN, Sulfa, Ambien","['Body temperature increased', 'Dizziness', 'Dry mouth', 'Flushing', 'Nausea', 'Paraesthesia oral', 'Vomiting']",1,MODERNA,IM 924006,PA,55.0,M,"redness, swelling, warm to touch, itchy 9 days later.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,"multi vitamin, amiodipine 5 mg, losartan 100 mg, rosuvastain 5 mg",none,none,,none known,"['Erythema', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,IM 924007,CA,42.0,F,"""Moderna COVID-19 Vaccine EUA"" Woke up to a large red welt about 2 inches below the injection site,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,PVT,"1/2 tab of 20-25 mg Lisinopril/Hydrochlorothiazide, 1 cap 20 mg Prozac, 300 mg tab Bupropion, Naltrexone 25 mg tab",No,,I got the chicken pox after getting the Varicella vaccine,,"['Injection site erythema', 'Injection site reaction', 'Urticaria']",1,MODERNA,IM 924008,,38.0,F,HA Flu like Sx,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/27/2020,4.0,WRK,,,,,,"['Headache', 'Influenza like illness']",UNK,MODERNA, 924009,IN,39.0,F,"Patient scheduled return visit, sat down and after about 10 minutes she complaint of not being able to breath. Line monitor called EMS and APRN. Patient was brought by WC to a room.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Xanax, metformin","DM, Anxiety, morbid obesity","DM, Anxiety, morbid obesity",,Ibuprofen,['Dyspnoea'],1,MODERNA,IM 924010,NY,51.0,F,"Patient complained of episodes of numbness on left side of face along with difficulty speaking lasting up to 5 minutes. She has had 4 episodes since vaccination, last one was 1 week ago",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/18/2020,0.0,PVT,Ibuprofen 400 mg,,,,Prednisone,"['Hypoaesthesia', 'Speech disorder']",1,PFIZER\BIONTECH,IM 924011,MD,46.0,F,"Moderna COVID-19 Vaccine EUA sharp piercing headache at back of head onset at time of injection. After 2-3 minutes the headache diminished but did not go away fully. Patient took Tylenol 500mg to combat the headache. Headache has lasted throughout the next few days and has finally gone away on day 7 post injection. The headache was unusual in that when the patient moved their eyes or read or moved facial muscles the pain became stronger. The patient's eyes were sore and tender for the duration of the timeframe mentioned. Also, the injection site was completely pain-free on the day of the injection. However, the following 5 days after injection, the site became very sore and tender with no redness or swelling present. Patient did contract the COVID virus and tested positive on day 4 post-injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,garlic multivitamin vitamin C Meloxicam 15mg Dicyclomine 40mg Nortriptyline 50mg vitamin B12 vitamin D3,,sero-negative arthritis migraines Irritable Bowel Syndrome,,penicillin codeine lortab percocet darvocet lexapro lyrica HCTZ gabapentin metoprolol,"['Eye pain', 'Headache', 'Immediate post-injection reaction', 'Injection site pain', 'SARS-CoV-2 test positive']",1,MODERNA,IM 924013,NY,57.0,F,"patient became itchy on her chest and arms at 1510, felt heart palpitations, and cold Benadryl 25mg given at 1512 and a second Benadryl 25mg at 1530 Patient states feeling better at 1347",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Hydrochlorothiazide, Losartan, Celebrex, Tizanidine, Lotemax, Artificial Tears, Vitamins C, Magnesium, Zinc","HTN, Fibromyalgia",Breast Cancer 2019,,No Known Allergies,"['Feeling cold', 'Palpitations', 'Pruritus']",1,MODERNA,IM 924014,MA,42.0,F,"Day 2 and 3 migraine Day 3 - 8 muscle aches legs, fatigue, some join aches, loss of appetite Day 7 - 8 swelling of lymph node under left arm , rash and swelling at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,WRK,"Lamotrigine, LoLoestrin, Vit D, Multivitamin,",none,Bipolar Disorder - fully managed on Lamotrigine,,Level four allergy to hornets,"['Arthralgia', 'Decreased appetite', 'Fatigue', 'Injection site rash', 'Injection site swelling', 'Lymphadenopathy', 'Migraine', 'Myalgia']",1,MODERNA,SYR 924015,TX,21.0,F,Moderna COVID-19 vaccine administered outside of company's standing order protocol(patient received vaccine while pregnant) no symptoms or adverse events reported by patient,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PHM,,,,,,['Pregnancy'],1,MODERNA,IM 924016,KY,25.0,F,"Nausea, Fever/chills, body aches, lingering headache starting at 3:30AM 01/05/2021. Symptoms continued all day 01/05/2021. Fever spiked to 102 around 10PM on 01/05/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Pantoprazole; Amitriptyline; Blisolvi FE,,,,Sulfa drug,"['Chills', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 924018,,72.0,F,"Experienced tingling 10 minutes after the injection. Describes tingling on the left side from ear to her jaw including tongue and throat feeling ""funny"". Patient escorted to ER . CT scan negative",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/26/2020,0.0,UNK,,,,,,"['Immediate post-injection reaction', 'Oropharyngeal discomfort', 'Paraesthesia', 'Paraesthesia oral']",1,MODERNA, 924019,NH,32.0,F,"Arm soreness, facial flushing immediately following injection. Pt later became short of breath with mid sternal pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Chest pain', 'Dyspnoea', 'Electrocardiogram normal', 'Flushing', 'Immediate post-injection reaction', 'Pain in extremity']",1,MODERNA,IM 924021,MA,35.0,M,"Patient reported noticing an erythemic area around injection site that began 7 days after his injection. The area was noted to be puritic and erythematous. To date, entire erythematous site is about 10cm by 4cm. The patient has left axillary lymphadenopathy but is otherwise asymptomatic. The patient encircled the area last night and noticed about 1 cm spread this AM. He took loratidine last night and this morning without effect.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,PVT,Melatonin as needed for sleep,,Mild tourette's syndrome,,Penicillins,"['Alanine aminotransferase normal', 'Aspartate aminotransferase normal', 'Blood bicarbonate increased', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine normal', 'Blood glucose normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea normal', 'C-reactive protein normal', 'Haematocrit normal', 'Haemoglobin normal', 'Injection site erythema', 'Injection site pruritus', 'Lymphadenopathy', 'Lymphocyte percentage decreased', 'Platelet count normal', 'White blood cell count increased']",1,MODERNA,IM 924022,VA,32.0,M,"5 MIN POST ADMINISTRATION: SOB, DIZZINESS, CHANGE IN VISION - GAVE BENADRYL 25 MG AND 1 VIAL ALBUTEROL VIA NEB 1 HOUR POST ADMINISTRATION: SWOLLEN LIPS, RASH ON CHEST AND ARMS - GAVE 1 DOSE OF EPI PEN AND IM SOLU-MEDROL, CALLED EMS, LEFT TO GO TO ER BP, HR, OXYGEN STABLE THROUGHOUT",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,SEN,"promethazine 12.5 mg tab, saline 0.65% nasal spray, multivit, gabapentin 300 mg, klonopin 1mg, diclofenac 50 mg, acetaminophrn 650 mg, dulcolax suppository, senna 8.6 mg tab, mirtazapine 7.5 mg, vit D3 50 mcg, risperidone 0.75 mg","cognitive impairment d/t traumatic brain injury (traumatic subdural hemorrhage with loss os consciousness >24h with return to consciousness), anemia, muscle atrophy, bipolar disorder, aphasia following other cerebrovasc dz, MDD, dysphagia, hx of COVID19 (12/22/20)",,,"Codeine, Trileptal, bee venom","['Dizziness', 'Dyspnoea', 'Lip swelling', 'Rash', 'Visual impairment']",1,PFIZER\BIONTECH,IM 924023,CA,37.0,F,"Parasthesias began in my lower extremities intermittently about 36 hours following administration. These spread to my upper extremities and became consistent. Occasionally will appear in lips and trunk. These are associated with sensation of numbness and some discomfort in my extremities. I'm also experiencing significant brain fog, difficulty concentrating, and fatigue. Headaches are occurring about every other day. Symptoms are present currently and have remained relatively consistent in severity. Was evaluated by urgent care on December 28 and encouraged to observe. Was evaluated in the ER by neurology on January 4. There leading hypothesis is vaccine related immune response. Neurologic exam was largely normal, being evaluated by a specialist in the coming days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/23/2020,2.0,WRK,None,None,History of migraine,,Latex,"['Blood thyroid stimulating hormone', 'Disturbance in attention', 'Fatigue', 'Feeling abnormal', 'Full blood count normal', 'Haemoglobin', 'Headache', 'Limb discomfort', 'Metabolic function test normal', 'Neurological examination normal', 'Paraesthesia', 'Paraesthesia oral', 'Red blood cell sedimentation rate normal', 'Type III immune complex mediated reaction', 'Vitamin B12']",1,PFIZER\BIONTECH,SYR 924024,NY,44.0,F,"Flu like symptoms 105 fever, chills, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,,Had surgery on 12/22/2020 for breast Reconstruction after mastectomy,Fibromyalgia,,Shellfish Penicillin Latex,['Influenza like illness'],1,MODERNA,SYR 924025,CA,48.0,F,"12/22/2020 2:50pm Shortly after the vaccine was administered experienced SOB and wheezing. Albuterol MDI utilized and symptoms subsided. 3:30pm Mild Headache and back pain. Fatigue and lethargic. Pain scale 3-4 5:15pm Headache increased intensity. Fatigue and lethargic. Back pain still the same, took Motrin 600mg-OTC Wheezing, used Albuterol-MDI 7:30pm Headache and back pain increased intensity 12/23/2020 4:54am Woke up with wheezing, headache and back pain. Pain scale 6 Albuterol-MDI utilized 7:42am Wheezing and SOB, Albuterol utilized and symptoms subsided 3:00pm Headache increased intensity throughout the day. Difficulty focusing and multitasking. Loosing train of thought. Fatigue and lethargic. Pain scale7. Motrin OTC 800mg taken with evening medications and went to sleep. 12/24/2020 7:23am Woke up with severe headache and anosmia. 12/25/2020 Headache and anosmia 12/26/2020 Headache and anosmia 12/27/2020 COVID test-Negative result Headache and anosmia 12/28/2020 Headache and anosmia 12/29/2020 Headache and anosmia. Doctor's appointment. Headache treated with Tramadol 12/30/2020 Headache and anosmia. Pain scale 6 12/31/2020 Headache and anosmia Pain scale 3-4 01/01/2020 Headache and anosmia Pain scale 2-3 01/02/2020Headache and anosmia Pain scale 0-2 01/03/2020 Headache and anosmia Pain scale 0-1 01/04/2020 Anosmia 01/05/2020 Headache and anosmia Pain scale 2-3 01/06/2020 Headache and anosmia Pain scale 3-4",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,PVT,"Albuterol-MDI, Allegra, Estradiol cream, Estradiol tablet, Claritin tablet-OTC, Omeprazole capsule, Triamcinolon ointment, Zyertec-OTC, Guaifenesin/Phenylephrine/Acetaminophen tablet-OTC","Asthma, laryngitits, ear infection-twice different ear","Asthma, migraines, s/p gastric bypass nausea/vomiting, hives, idopathic uticaria",,Iodine compound Shellfish,"['Anosmia', 'Back pain', 'Disturbance in attention', 'Dyspnoea', 'Fatigue', 'Headache', 'Immediate post-injection reaction', 'Lethargy', 'Mental impairment', 'SARS-CoV-2 test negative', 'Wheezing']",UNK,PFIZER\BIONTECH,IM 924026,GA,53.0,F,Left side neck raised lymphnode,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,MIL,,,,,,['Lymphadenopathy'],1,MODERNA,IM 924027,NY,58.0,F,"approx 10-15 minutes post vaccine administration, patient reported tightness in throat, left arm tingling, and right shoulder pain. Epipen was administered, patient was taken by ambulance",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,aspirin prn,,none,,nkda,"['Arthralgia', 'Paraesthesia', 'Throat tightness']",1,MODERNA,IM 924028,PA,44.0,F,Hot; heaviness in right arm / sore; feeling flushed; feeling hot in legs. Monitored for total of 40 minutes. Laid on a stretcher and systems resolved. Released to home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,unknown,unknown,unknown,,Codeine Sulfa,"['Feeling hot', 'Limb discomfort', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 924029,NY,53.0,F,"after 20-30 minutes my throat started to get tight, I could not swallow properly, I felt dizzy & my heart was beating fast.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,plaquinel synthroid,Lupus Hypothyroidism,,,none,"['Dizziness', 'Dysphagia', 'Heart rate increased', 'Throat tightness']",UNK,MODERNA,IM 924030,,,U,The injection site is warm and has a red bumpy rash,Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Injection site rash', 'Injection site warmth']",1,MODERNA,IM 924031,MD,56.0,M,"15 hours after shot experianced, dizziness, feeling of fainting, difficulty breathing mild pressure chest pain. Was taken to local Er. Ekg, cat scan chest xrays all negitive. Blood work negitive. No past history of symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,WRK,"Tylenol, bayer, cialis",None,None,,None,"['Blood test normal', 'Chest X-ray normal', 'Chest discomfort', 'Chest pain', 'Computerised tomogram', 'Dizziness', 'Dyspnoea', 'Electrocardiogram normal']",1,MODERNA,SYR 924032,NH,52.0,F,Patient received vaccine on 12/29. On 1/6/20 she developed a erythematous oval area at the site of injection on her right deltoid with mild pruritus and warmth and localized tenderness.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/06/2021,8.0,UNK,amphetamine-dextroamphetamine (ADDERALL) 15 MG Oral Tab Take 30 mg by mouth TWICE A DAY AS NEEDED (Daytime sleepiness). for ADHD amphetamine/dextroamphetamine (ADDERALL XR) 30 MG Oral CAPSULE SR 24 HR Take 30 mg by mouth EVERY MOR,None,Neck swelling Tingling in extremities Tremor Fatigue Osteoporosis Degenerative disc disease Kidney stones Allergic rhinitis Chronic pain Adult ADHD Current smoker Vitamin deficiency Thyroid nodule Depression Teeth problem Eczema Osteoporosis Corneal abrasion Bipolar 1 disorder,,Ivp Dye Urticaria High Patient Reported 10/4/2016 Estradurin [Polyestradiol] Headache Medium Patient Reported 9/21/2015 Penicillins Urticaria Medium Patient Reported 5/28/2015 Prozac [Fluoxetine] Urticaria Medium Patient Reported 5/28/2015 Antidepressants Iodine Unknown 5/28/2015 Patient denies Pollen Sneezing Side Effect Side Effect 5/28/2015,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",UNK,MODERNA, 924033,OH,53.0,F,"About 25-30 minutes after receiving the vaccine, patient stated she felt dizzy, had a ""lump in my throat"" and had difficulty breathing. She had already left clinic and drove to the Emergency Room. At the hospital, they gave patient and EKG and chest Xray and an injection of Benadryl. Patient stated she felt better within 10 minutes of receiving the Benadryl injection. Difficulty breathing and ""lump in throat"" went away. Patient stated that she was diagnosed with an allergic reaction to the vaccine and was advised not to get another COVID vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,None,None,None,,Allergy to Lisinopril: caused coughing,"['Allergy to vaccine', 'Chest X-ray', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Sensation of foreign body']",1,MODERNA,IM 924034,OK,35.0,F,The following day 10am exp stomach cramps. On the following day and 12/19 exp severe stomach cramps. I have had no issues since.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,No,No,No,,No,['Abdominal pain upper'],1,PFIZER\BIONTECH,IM 924035,TX,28.0,F,"So I got the vaccine Monday night after work. Tuesday and Wednesday I ran a super high fever, body aches, lymphnode swelling on that side. No big deal . Well Thursday morning I woke up with a rash on both of my legs and my legs swollen like tree trunks. It?s a petechial rash. I called the pharmacist told to take Benadryl and Zyrtec since Friday. So I went to the doctors last night since I still have this rash and it hasn?t gotten any better with Benadryl and Zyrtec. I got blood work done today. And I have to get an arterial and venous Doppler done on Wednesday next week. They are concerned I may have blood clots since my legs are so swollen with a petechial rash. They are also giving me steroid tapper.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,OTH,prenatal vitamins and emergency c,none,none,,amoxicillin,"['Full blood count', 'International normalised ratio', 'Lymphadenopathy', 'Metabolic function test', 'Pain', 'Peripheral swelling', 'Petechiae', 'Prothrombin time', 'Pyrexia', 'Rash']",1,MODERNA,IM 924036,MD,53.0,F,States she had swelling in her forearm and hand,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,WRK,,,obese,,reaction noted from cortisone injection 6 weeks earlier,['Peripheral swelling'],1,PFIZER\BIONTECH,IM 924038,NY,41.0,M,Patient was dizzy post vaccine. He hadn't taken his antihypertensive medications. He required extra recovery time and the dizziness subsided,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,no known,['Dizziness'],1,MODERNA,IM 924039,AK,62.0,M,"tingling in mouth and lips, some numbness followed, swelling/puffy feeling on throat under jaw, shivering. Throat and back of tongue started to feel swollen. Started on a benedryl drip and in about 20 minutes I started feeling better, chills stopped, throat improved. After 45min to an hour I went home. Received shot around 10am, symptoms started about 20min later. Received treatment 15 min after reporting symptoms. Took benydryl at 5pm, 9pm, 2am. Took tylenol at 5pm. Jan 6 woke up felling like a fever and minor tingling in mouth and lips. took benedryl at 7am. Slept through the night without symptoms. Taking a 25mg bendryl every 5 hours and ibprofen/tylenol alternating every 6 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PUB,"Carvidolol; levothyroxine; Flonase; montelukastat; .80 asperin; CoQ10; turmeric; Vit b12, c, d, zinc, garlic; kreel oil; fish oil; biodin; milk thissle; multivitamin",respiratory - alergy/asthma,thyroid; cardiomyopathy; arthritis,,"red meat, mostly steak","['Chills', 'Hypoaesthesia oral', 'Paraesthesia oral', 'Pharyngeal swelling', 'Pyrexia', 'Swelling', 'Swollen tongue']",1,PFIZER\BIONTECH,SYR 924040,NM,70.0,F,"light headed, sweaty. 25 benadryl orally.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PHM,"Baclofen 10mg, Escitalopram 10mg, Allopurinol 100mg.",,"Hypertension, hypothyroidism, gout.",,Penicillin,"['Dizziness', 'Hyperhidrosis']",1,MODERNA,IM 924041,NH,36.0,F,"Fever, Shortness of breath, Chills, Migraine",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,,,,,,"['Cardiac monitoring', 'Chills', 'Dyspnoea', 'Migraine', 'Pyrexia']",1,MODERNA,IM 924043,NY,42.0,F,"Moderna COVID-19 Vaccine EUA Twitching bottom lip, from approx 3:40pm - current (3:56pm)",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,Prilosec OTC 20mg,GI Bug 12/24 - negative covid test ensued,GERD,,NKA,['Muscle twitching'],1,MODERNA,SYR 924044,IN,34.0,F,Extreme Nausea for 36 hours migraine for 2 days Change in taste started the morning of day 2 after Fever for 36 hours after Arm soreness still happening Knot and heat at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PUB,Vitamin D3 4000 unit Vitamin C 1000mg Aspirin 325mg Claritin 10mg,"Tested positive for Covid-19 on December 18, 2020",None,,None,"['Injection site nodule', 'Injection site warmth', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Taste disorder']",UNK,MODERNA,SYR 924045,NY,42.0,F,Severe hives on the face and the injection site day#8 after injection. every 6-8hr Benadryl helps. Follow up with an Allergist,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,None,None,None,,Latex-rash,"['Injection site urticaria', 'Rash', 'Urticaria']",1,MODERNA,IM 924046,CA,52.0,F,"By evening the same day of injection the injection site became increasingly tender to the touch. The second night, the left arm hurt to move at all and kept patient up most of the night. However, was resolved the following day. Intense migraine Headache every day since",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,UNK,,,,,,"['Injected limb mobility decreased', 'Injection site pain', 'Migraine']",1,MODERNA,SYR 924047,NJ,52.0,F,"patient experienced a hive on her wrist after receiving vaccine. of note, she was not sure if it was there prior to being vaccinated. patient was offered to be taken to the emergency room for further treatment/monitoring but she refused. she was monitored for 15 minutes in clinic area and no other hives appeared. patient was instructed to seek medical care if symptoms worsened. patient said she was going to take Benadryl once she got home- unknown at time of submission if that occurred.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,not known,not known,not known,,Tamiflu -rxn was reported as angioedema,['Urticaria'],1,MODERNA,IM 924050,HI,55.0,F,"anaphylaxis, dyspnea",Not Reported,,Yes,Yes,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,,unknown,unknown,,"Zolpidem, chocolate","['Anaphylactic reaction', 'Dyspnoea']",UNK,MODERNA, 924051,GA,26.0,F,Pain in arm and at injection site - red spot slightly larger than a quarter - tender to touch and warm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Lexapro,,,,Ceclor,"['Erythema', 'Injection site pain', 'Pain in extremity', 'Skin warm', 'Tenderness']",1,MODERNA,SYR 924053,GA,51.0,F,"Little ball size in the beginning. Left inner upper arm, warm to touch, very tender. Now about the size of a quarter. Seems to be getting larger with the warm compresses, per Dr's orders.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,"Prednisone, Celexa, Irbesartan, HTCZ, Plaquenil, potassium, Vitamin D, furosemide, folic acid.",no,Systemic Lupus,,"Bactrim, tomatoes, Augmentin","['Pain of skin', 'Skin warm']",1,PFIZER\BIONTECH,SYR 924054,PA,55.0,F,"Wave of coolness reported. Lightheadedness that resolved 10 minutes post vaccine. Blood pressure was high on taking 183/91. Patient reports History of ""White Coat Hypertension"". Symptoms resolved. MOnitored for at least 15 minutes and released to home. Recommended patient follow-up with PCP regarding potential underlying hypertension..",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,Unknown,unknown,unknown,,Sulfamethoxazole with trimethoprim (Bactrim),"['Dizziness', 'Feeling cold', 'Hypertension']",1,PFIZER\BIONTECH,IM 924055,MN,52.0,F,"Fatigue, severe headache, muscle aches. slight sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,"Flucanizole, montelukast, clarithromycin",None,,,"Aspirin, Codeine. Food: gluten and dairy sensitivities","['Fatigue', 'Headache', 'Myalgia', 'Oropharyngeal pain']",1,PFIZER\BIONTECH,IM 924056,IN,59.0,F,"1/5/20: 6:15 pm Became tired, chilling, afebrile, cold touch, soreness at injection site. 9:00 pm dizziness, tightness around right upper arm, swelling in right axilla. afebrile. 1/6/20: 5:00 am; chilling subsided. dizziness, weakness and jittery feeling in both legs, soreness at injection site, no redness, swelling in axilla slightly improved. Heart rate 72, respirations 16, 02 sat 96%. bp 129/75. 9:00 am: dizziness, right axilla swelling gone. Soreness in right axilla, weakness in lower extremeties improving. 11:00 am : weakness and jiters subsided, right axilla remains sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,,,Stage 3a Kidney Disease,,,"['Asthenia', 'Chills', 'Dizziness', 'Fatigue', 'Feeling jittery', 'Injection site pain', 'Oedema peripheral', 'Peripheral swelling']",2,PFIZER\BIONTECH,IM 924057,NV,30.0,F,injection site redness/pain/localized allergy reaction or signs of infection at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,Zoloft 150 mg,"Cough, GI upset, Fever (102) two weeks prior to vaccine (tested for Covid and was negative)",None,,None,"['Injection site erythema', 'Injection site hypersensitivity', 'Injection site infection', 'Injection site pain']",1,MODERNA,IM 924058,GA,40.0,F,About 2 inch swollen red circle that itches like a bug bit about hourly,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/04/2021,7.0,MIL,Oral contraceptive Flonase,None,None,,None,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA,SYR 924059,,50.0,F,Flu Sx,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/05/2021,12.0,WRK,,,,,,['Influenza'],UNK,MODERNA, 924060,MN,55.0,F,"Temperature, cough, chest pressure, fatigue, redness and bump at immunization site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,"levothyroxine, Zoloft",COVID-19 date of onset 11/28/2020,hypothyroidism,,Ceftin,"['C-reactive protein', 'Chest discomfort', 'Computerised tomogram thorax', 'Cough', 'Fatigue', 'Fibrin D dimer', 'Injection site erythema', 'Injection site mass', 'Pyrexia']",1,PFIZER\BIONTECH,IM 924061,IN,52.0,F,"Feeling unwell, tiredness, fever, chills, joint pain, headache. muscle pain. nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,None,None,None,,None,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924062,CT,38.0,F,"Axillary lymphadenopathy with neuropathy to hand and fingers requiring nsaid, topical analgesic. Off work x3 days after onset on 1/4/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/03/2021,4.0,PUB,,None,None,,PCN,"['Lymphadenopathy', 'Neuropathy peripheral']",1,MODERNA,IM 924063,VA,25.0,F,I have moderate swelling and redness to right upper arm where I received the vaccine. It is warm to the touch and firm all over. I have not been bit by anything to my knowledge and the redness is pretty consistent all over- also not indicative of a bite. The site is probably three inches wide. I have pictures if anyone wants them.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PUB,"Modafinil, B12, Vitamin D, Vitamin C",,Narcolepsy,,Allergic to cats,"['Injection site erythema', 'Injection site swelling', 'Skin warm']",1,MODERNA,IM 924064,NJ,26.0,F,"Red, tender bump at injection site started approx one week after vaccination. Circular, measures 4cmx4.5cm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PVT,Venlafaxine,None,None,,None,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 924065,WI,41.0,F,"Left arm pain and other muscle pain, headache, fever, nauseous, sleepy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,"Tizanidine, cetirizine, Bupropion XL, hydroxyzine, escitalopram, pantoprazole,",No,Kidney,,,"['Headache', 'Myalgia', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Somnolence']",UNK,MODERNA,SYR 924066,SC,36.0,F,"Trouble breathing. Chest tightness, hives, redness, started at 10:08 and it was called as a code at 10:15 and they administered epi",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2020,01/06/2021,366.0,WRK,"Ibuprofen 400 mg to help with the vaccine taken the night before. Was given 2 shots of epi, soul-medrol and Benadryl via IV.",Migraines,Anaphylaxis,2018 flu shot/ allergic reaction- flucelvax,"Peanuts, tetanus, shellfish","['Blood test', 'Cardio-respiratory arrest', 'Chest discomfort', 'Dyspnoea', 'Erythema', 'Hypersensitivity', 'Laboratory test', 'Urticaria']",1,MODERNA,SYR 924067,,44.0,F,local redness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/28/2020,6.0,WRK,,,,,,"['Erythema', 'Local reaction']",UNK,MODERNA, 924068,PA,60.0,F,"Sunday night, 1/3/21, I noticed my left upper arm being itchy. Monday morning, 1/4/21, after my shower I noticed the itching again and an erythematous area, about 7 x 9cm, where I had received the injection. Today the area is much larger, 15 x 20cm, less red and still itchy. A localized allergic reaction 10 days after the vaccine was received seems unusual to me.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/03/2021,10.0,WRK,"Synthroid, Pantoprazole, Breo Ellipta, Ramipril, Bupropion, Sertraline, Victoza, Crestor, Vitamin B2, Magnesium, CoQ10, Vitamin D, Loratadine, Famotidine, Zinc, Emgality, Botox.",none,"HTN, Type 2 DM, Hypothyroidism, Hyperlipidemia, GERD, Asthma Migraines/Chronic daily Headaches, Allergic Rhinitis",,"Shellfish, fish, adhesives","['Injection site erythema', 'Pruritus']",1,MODERNA,IM 924069,MI,24.0,F,"Within 24 hours having memory loss, foggy headedness, forgetful, now we realize she had at least two seizures that week. 10/12/19 was taken my ambulance after grand mal seizure; no history of seizures prior. Dr. put on anti-seizure meds 3/13/20 had another convulsive seizure 11/19/20 severe seizure episode, status epilepticus, put on ventilator, 3 days in ICU, IV anti-seizure drugs",Not Reported,,Not Reported,Yes,7.0,Not Reported,N,10/03/2019,10/04/2019,1.0,PVT,None,None,,,"Nickel, Cobalt, fluoroquinolones","['Amnesia', 'Blood test', 'Computerised tomogram', 'Electroencephalogram', 'Feeling abnormal', 'Generalised tonic-clonic seizure', 'Intensive care', 'Lumbar puncture', 'Magnetic resonance imaging', 'Mechanical ventilation', 'Memory impairment', 'Seizure', 'Status epilepticus', 'Ultrasound scan', 'X-ray']",,SANOFI PASTEUR,SYR 924070,MN,21.0,F,"Patient was administered the first dose of the Pfizer vaccine 0.5mg IM Rt Deltoid this AM in the Covid-19 Vaccine Clinic.Patient waited 12 min went to change her clothes and come back to the clinic with complaints of hives and feeling warm. Patient had raised red welts on right upper arm. Patient has a history of Anaphylaxis reaction with a Meal Ready to Eat (MRE) in the past, other allergies to grapefruit seed extract with reaction of edema. Pt has no c/o of SOB or Chest pain, no other swelling at this time. Dr. notified, 0.3mg Epinephrine 1mg/mL (1:1000) given IM Left Deltoid, 25mg Benadryl IM given Rt Deltoid per MD verbal order and anaphylactic protocol. Pt transferred by wheelchair to the ER for further evaluation. Report given to ER RN.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,"Ibuprofen 800 mg PRN, Hydrocodone-acetaminophen 5-325mg PRN, Albuterol 108 (90base) MCG/ACT inhaler, Zoloft 50mg, Epi Pen, Adderall XR 10 mg, PRN, Adderall 20 mg - 2 tabs bid, Zyrtec 10mg PRN, Mirena 52mg IUD.","12/4/2020 Nausea, diarrhea, body aches headache. Test for Covid Negative",ADHD,,Grapefruit Seed Extract,"['Erythema', 'Feeling hot', 'Peripheral swelling', 'Urticaria']",1,PFIZER\BIONTECH,IM 924071,KS,51.0,F,"Woke up with a rash on trunk of my body. Rash also noted on my back and top of both thighs. Woke up around 4 am with body aches/headache. I took 400 MG of Advil. Rash was not there at that time. Went back to bed and woke up around 730-740 AM and noted the rash to my stomach. I took 1 Benadryl at that time, then itching got worse and took another Benadryl. Currently rash continues to be red and raised and the body aches/headache remain the same. Placed call to medical clinic and left a message.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,PUB,Metoprolol 25 mg PO daily Alprazolam 1 mg PO at HS Melatonin 5 mg PO at HS,GI bug,Fibromyalgia,,Demerol Medrol dose pack,"['Headache', 'Pain', 'Rash', 'Rash erythematous', 'Rash papular']",1,MODERNA,IM 924072,GA,25.0,M,"The patient was administered the vaccination, observed for 15 minutes following the vaccination, after which he left to return to work at a pharmacy. The patient came back into the store about on hour later to pick up some things for his pharmacy and reported feeling a little chest pain. The patient was then informed to keep monitoring the pain and if it got any worse to go to the doctors office. About 2 hours later, the patient called when on the way to the emergency room and reported chest pain and a fever of 102 degrees (at the highest). Around 3pm, which was about 6 hours after the vaccination was administered, the patient reported chest pain was alleviated and that the emergency room treated him for a migraine/nausea with Tylenol #3, Fioricet and Zofran.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PHM,Unknown,None known,None known,Migraine and severe vomiting,Latex,"['Chest pain', 'Migraine', 'Nausea', 'Pyrexia']",1,MODERNA,IM 924073,VA,40.0,F,"Had arm soreness last night. Woke up with body aches, despite taking tylenol. Have had chills and developed a fever of 101.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Synthroid, liothyronine, hydro cortisol, trazadone, fiber, probiotic",Had a cold and ear infection (12/10),"Thyroid disease, gall bladder removal",,Percoset,"['Chills', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 924074,IA,36.0,F,"1/4/2021 vaccination. Arm started to hurt at 9:30 pm. Developed rigors, muscle aches; lasted till 6am. Next 24 hours; fatigue, nausea, body aches. *wasn't able to do much *Can't still really move arm *Had COVID in August *3rd pregnancy. 06/03/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Chills', 'Exposure during pregnancy', 'Fatigue', 'Mobility decreased', 'Myalgia', 'Nausea', 'Pain', 'Pain in extremity']",1,MODERNA,SYR 924075,IN,59.0,F,"Woke up the following morning with terrible body aches, especially to upper back, neck, lower back and legs. Headache, diarrhea, and tiredness. Was unable to ""function"", and slept most of the day. Was still having some of those symptoms the second day, but not as bad.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,ASA 81mg Black Cohosh 80mg Nifedipine 30mg Pantoprazole 40mg Ezetimibe 10mg,None,None,,NKA,"['Blood test', 'Diarrhoea', 'Fatigue', 'Headache', 'Pain']",1,PFIZER\BIONTECH,IM 924076,WI,19.0,F,"Received the Covid-19 vaccine on Jan 2. She reports symptoms starting the morning of 1/3 with body aches, migraine, chills, throbbing arm pain, and fatigue. Was unable to work on 1/4.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/03/2021,1.0,WRK,,,,,,"['Chills', 'Fatigue', 'Migraine', 'Pain', 'Pain in extremity']",1,MODERNA,IM 924077,,49.0,F,"Patient experienced dizziness, ""brain fog"", and elevated blood pressure 15 minutes post vaccine administration",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Blood pressure increased', 'Dizziness', 'Feeling abnormal']",1,PFIZER\BIONTECH,IM 924078,FL,60.0,F,"Client received vaccine at approximately 3:50pm, waited in observational area x30min. Left with husband, stated that she got a few miles down the road and starting experiencing tightness in her chest and flushing. She took 50 mg of Benadryl, 30mg of prednisone and two puffs on her inhaler. She returned to the clinic, upon assessment from nursing she looked extremely flushed and anxious, she stated that she still felt tightness and that she had a history of anaphylaxis once before and had used an epi pen in the past. She had an epi pen with her and questioned whether or not she should give it to herself. BP was 190/68, pulse was normal, respirations normal, she continued to experience tightness and ""not able to catch my breath"", encouraged to use epi pen. She administered epi pen to right thigh at approximately 4:45PM, 911 called. Within a few minutes, she stated she was feeling better, less tightness in the chest, flushing was subsiding. BP at 190/70 at 4:52. EMS on scene at 5:03pm. Vitals normal , EKG normal. Client decided not to transport with EMS.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,unknown,"No reported illness at time of vaccine, unknown for month prior",unknown other than client stated cardiac issues,,"Bactrim, Augmentin , Cats","['Anxiety', 'Chest discomfort', 'Dyspnoea', 'Electrocardiogram normal', 'Flushing']",1,MODERNA,IM 924080,TX,27.0,F,DELAYED TYPE HYERSENSITIVITY AT SITE OF INJECTION,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/05/2021,6.0,PVT,GIANVI,NONE,NONE,,NONE,['Injection site hypersensitivity'],1,MODERNA,IM 924081,CA,42.0,F,tingling on left pinky warmth hot sensations moving up towards the cheek cheek and lips went numb,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Feeling hot', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia']",1,PFIZER\BIONTECH,SYR 924082,NY,45.0,F,"Had mild pain the day after vaccination, then redness and swelling for a day, which resolved until the redness and swelling returned yesterday. She denies any pain or difficulty moving her shoulder, states the area is itchy. No fever/body aches/chills. No headache. She has had similar reactions to the Pneumovax vaccine, was treated for cellulitis. She has not tried any home treatments, not taking anything for pain, since there is no pain. No chronic medical problems or regular medications. Findings most consistent with localized reaction vs cellulitis, encouraged symptomatic treatment with cool compress, NSAIDs, etc. Counseled patient that this should not prevent her from receiving a second dose of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,None,None,None,Pneumovax in 2018,None. Had similar localized reaction to pneumovax in 2018,"['Erythema', 'Pain', 'Pruritus', 'Swelling']",1,MODERNA,IM 924083,VA,26.0,F,large local injection site reaction that started the day after vaccination. Redness/swelling/warmth/itching,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,"aspirin 81mg, melatonin 3mg, Zofran 8mg, Inderal 20mg, xarelto",unknown,"factor V leiden, POTS",pertussis,pertussis vaccine,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA, 924084,,62.0,F,"Cellulitis, treated with abx",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,WRK,,,,,,['Cellulitis'],UNK,MODERNA, 924085,PA,25.0,F,"Shortness of breath; lightheadedness reported 13 minutes after injection. Symptoms resolved with a snack. Vitals within normal limits. juice and crackers given. Patient reports similar vasovagal reactions after blood draws and other injections. Monitored for 45 minutes, symptoms resolved and released home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,unknown,unknown,unknown,,NKDA,"['Dizziness', 'Dyspnoea']",1,PFIZER\BIONTECH,IM 924086,CA,37.0,F,Woke up with a rash all over a few days later.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/25/2020,2.0,WRK,"Singular, birth control",Surgery last week from endometriosis,Endometriosis . allergies.,Flu symptoms following the flu shot.,"Shell fish, ampicillin, penicillin",['Rash'],1,PFIZER\BIONTECH,IM 924087,GA,25.0,M,"Pt states ""I woke up, ate breakfast and around 8:30am I started feeling dizzy and having blurred vision. I was working at the time and went to my local EMS station to get checked out. They checked my blood pressure and blood sugar. Blood pressure was normal but my blood sugar was low, around 68. They gave me a coke to drink and I went back to the Sheriff's office and about an hour later my blood sugar was around 90. I took the rest of the day off and come home. I took Extra Strength Tylenol and rested. I did have a headache a few hours later. I feel fine now but I have a mild headache.""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,none,none,none,,none,"['Blood glucose decreased', 'Dizziness', 'Headache', 'Impaired work ability', 'Vision blurred']",1,MODERNA,IM 924088,IN,35.0,F,"Nausea, intense body aches, fever, injection site soreness, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,None,None,Discoid lupus,,None,"['Injection site pain', 'Malaise', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,SYR 924089,CA,50.0,F,"at 1230 on 1/5/2021 mentioned individual begin to feel she was having trouble concentrating, felt cold and hot and tingling on scalp and nausea and felt like she was about to faint.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,OTH,"Klonopin, Lipitor, Vitamin D",none,None,,None,"['Disturbance in attention', 'Dizziness', 'Feeling of body temperature change', 'Nausea', 'Paraesthesia']",UNK,MODERNA,IM 924090,OH,39.0,M,"Patient given 1st dose COVID vaccine. No history of allergies or reactions to vaccinations. Immediately following injection, patient c/o of dizziness, clamminess, skin color became pale and he appeared diaphoretic. BP 153/93, P = 103 . He stated not having breakfast or lunch. Vitals repeated. BP 154/88, P 94. Rapid response team called at 1317. Patient given water and Reese cup. EKG completed. BS = 88. Vitals retaken - BP 158/88; P 95. Continued c/o dizziness and clamminess/ Moved to cart and monitored additional 30 minutes without further issues. MD came at 1405 and evaluated patient; patient cleared to go home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,none,None,Tachycardia,,None,"['Blood glucose normal', 'Cold sweat', 'Dizziness', 'Electrocardiogram', 'Hyperhidrosis', 'Immediate post-injection reaction', 'Pallor']",1,MODERNA,IM 924091,,37.0,F,"moderna civid 19 vaccine eua 1 week later I have a localized redness, circular rash over site of vaccination. No itching. Warm to touch. No pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,PVT,,,,,penicillin,"['Erythema', 'Injection site urticaria', 'Skin warm']",UNK,MODERNA, 924092,GA,32.0,F,fever chills/rigors body aches within 12 of getting vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Wellbutrin BCP,no,no,,,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924093,WI,19.0,F,"Received the Covid-19 vaccine on Jan 2. She reports symptoms starting the morning of 1/3 with body aches, migraine, chills, throbbing arm pain, and fatigue. Was unable to work on 1/4.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,WRK,,,,,,"['Chills', 'Impaired work ability', 'Migraine', 'Pain', 'Pain in extremity']",1,MODERNA,IM 924094,NJ,21.0,F,patient experienced rash post vaccination. patient also has raised red welt on arm that is still present 1 week post vaccination and has not improved. patient does report pain in the area but states that it is warm to the touch. patient continue to monitor for resolution and will update staff. patient stated she took advil - for headache but did not see improvement in arm redness. patient declined medical attention from the emergency room today.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,not known,not known,no known,,no known allergies,"['Erythema', 'Headache', 'Peripheral swelling', 'Rash', 'Skin warm', 'Urticaria']",1,MODERNA,IM 924095,AK,24.0,M,Arm soreness,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,SEN,Tremfya,None,None,,Fish,['Pain in extremity'],1,PFIZER\BIONTECH,SYR 924097,,24.0,F,Itching hives itchy throat within 20 minutes of receiving vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/06/2021,4.0,UNK,,,,,,"['Pruritus', 'Throat irritation', 'Urticaria']",1,PFIZER\BIONTECH,IM 924098,HI,55.0,F,"Diarrhea at 5:40am on 1/6/21 , 39 hours after getting the moderna Covid 19 Vaccine. No warning just watery and uncontrollable for a couple of hours . It was like I had taken colonoscopy prep. I ate dinner at 6 pm 1/5/21 and only had water to drink over night and in am before it started. It No stomach cramping noted. I do not know of anyone that I have had contact with who has had diarrhea in the past few days . The only thing I can think of is the vaccine as a reason.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/06/2021,2.0,WRK,"Hydrochlorothiazide, 12.5 mg, Tumeric,, Multivitamin, B12 B complex, Vit C , Ibuprofen 600 mg all taken at 4:30 AM on 1/4/21",None . I have a very strong immune system. I have not missed work until today since I started my job 5 years ago.,"Homocysteinemia, HTN",,Sulfa based antibiotics,['Diarrhoea'],1,MODERNA,IM 924099,TX,26.0,M,Woke up in Cold sweat the night after receiving shot. Sore arm the following day. Tested positive for corona virus 01/06/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,SEN,Adderall xr,"Cough , possible laryngitis 1 week prior to vaccine. Tested negative for corona virus 12/21/2020. Tested positive for Corona virus 2 days after shot 01/06/2021.",None,,No known allergies,"['Cold sweat', 'Coronavirus infection', 'Pain in extremity', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 924100,MO,48.0,F,"The next day my left eye was painful, like little ice picks going in, it was inflamed. It was difficult to see . I had Lasik about a year ago and I called my eye Doctor because I was nervous and I went to see him and he told me it looked like a allergic reaction. He put me on steroid drops. When I woke up Saturday morning my eye was fine, so I stopped taking the medicine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/17/2020,1.0,WRK,Chemotherapy TC Chemo Tylenol Claritin (used after chemo) Reglan (used after chemo) **Other medications but is in a chemo session doesn't have access,Breast Cancer,Breast Cancer,,IV dye latex Dicloxacilliam,"['Eye inflammation', 'Eye pain', 'Visual impairment']",1,PFIZER\BIONTECH,SYR 924101,NY,32.0,F,"12/24 headache, low grade fever, chills took advil. 12/29 2:30am severe reaction of itching aggressively from scalp to toes, broke out in red hives, tachycardic Itchy throat, swollen, ears and lips.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,UNK,,,,,,"['Chills', 'Ear swelling', 'Erythema', 'Headache', 'Lip swelling', 'Pruritus', 'Pyrexia', 'Tachycardia', 'Throat irritation', 'Urticaria']",1,PFIZER\BIONTECH,IM 924102,,59.0,F,Body Aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/04/2021,4.0,WRK,,,,,,['Pain'],UNK,MODERNA, 924103,PA,44.0,F,"Felt faint. Did not faint; however, assisted to floor to prevent falling/passing out. Resolved in 30 seconds Laid down and given water. Symptoms resolved. Vitals WNL. History of vasovagal reactions. Monitored for 15 minutes and released to home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,unknown,unknown,unknown,,NKDA,['Dizziness'],1,PFIZER\BIONTECH,IM 924104,MI,50.0,M,"""exactly 12 hours from the shot I developed body aches and chills. Muscle pain and fever. I was on the plane home and it hit the last hour. When I got home temp was 103.1. It lasted for about 8 hours - 10 hours""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Chills', 'Myalgia', 'Pain', 'Pyrexia']",1,MODERNA,IM 924105,NY,48.0,F,"Redness/pain/swelling at her vaccination site developed shortly after receiving her COVID-19 vaccine on 12/27/2020. She states the pain improved after a couple days, but the redness and swelling has remained about the same. She also reports daily low-grade headaches in this timeframe. She has been taking Tylenol and Aleve, in addition to her regular meloxicam for knee arthritis. She denies any fever/body aches/chills, no nausea/vomiting/diarrhea, no other associated symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,12/28/2020,1.0,PVT,Lexapro 20 mg,None,Anxiety,,None,"['Headache', 'Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 924106,AL,53.0,F,"PATIENT C/O DIZZINESS, HEADACHE, NAUSEA WITH DRY HEAVING, BP 184/90 AT 7:40AM. EPI 0.3MG ADMINISTERED AT 7:50AM. SYMPTOMS IMPROVED, BP 179/79 HR 114 AT 7:53AM. PATIENT REFUSED AMBULANCE OR FURTHER MEDICAL TX. STAFF MEMBER OBSERVED FOR AN HOUR UNTIL FAMILY ARRIVED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,UNKNOWN,UNKNOWN,UNKNOWN,,UNKNOWN,"['Dizziness', 'Headache', 'Nausea', 'Retching']",1,PFIZER\BIONTECH,IM 924107,MI,53.0,F,"In the end of December she developed right wrist pain and some mild swelling, then pain in both arms from elbows to hands, and then it started in the back on her thighs in hips bilaterally and her right ankle. She still has the headache that is unchanged x 1 month, but the other symptoms were new, and she had never had them before. She still has it and it is 1/6/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/27/2020,9.0,PVT,"cefuroxime, dexamethasone (not sure if she took that day but was given 2 pills on 12/15/20), estradiol, Flonase, Lexapro, Lisinopril, synthroid, Vistaril (not sure if took because it is a PRN medication), Vitamin D3",She was seen on 12/15/20 for having 1 month of sinus issues with severe frontal headaches.,"hx of anxiety, hx of depression, dilated bile duct, uterine fibroid, GERD, hx of diverticulitis, hypertension, hypothyroidism, irritable bowel syndrome, multinodular goiter, sinusitis, stress, thyroid nodule, tobacco use.",,"Levaquin, wellbutrin, codeine, penicillin","['Arthralgia', 'C-reactive protein increased', 'Headache', 'Pain in extremity', 'Red blood cell sedimentation rate increased']",1,PFIZER\BIONTECH,SYR 924108,NY,33.0,F,Shingles (herpes zoster) outbreak on abdomen.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,WRK,None,None,None,,None,['Herpes zoster'],1,MODERNA,IM 924109,CA,50.0,F,"The mentioned individual began to feel she had trouble concentrating, felt cold and hot, tingling on scalp and hands, nausea and felt like fainting.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,OTH,"Klonopin, Vit D and Lipitor",None,None,,None,"['Blood glucose normal', 'Disturbance in attention', 'Dizziness', 'Feeling of body temperature change', 'Nausea', 'Paraesthesia']",UNK,MODERNA,IM 924110,TX,59.0,M,"On December 30, 2020 at 1745 the patient was accessed since the patient complained of ""lymph node swelling."" On December 31,2020 the patient was reassessed as he the swollen lymph nodes, patient reported he was having trouble swallowing and it started the night of December 30 ,2020. The provider performed a physical exam and did not appreciate any swollen lymph nodes, but his tonsils were palpable and seemed slightly enlarged. Patient was then treated with Benadryl 25 mg intramuscularly once and prescribed 50 mg PO Benadryl every 8 hours for 4 days as needed if tonsil swelling occurred. The patient did not require any additional oral Benadryl after Benadryl intramuscularly was administered once on December 31, 2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Dysphagia', 'Lymphadenopathy', 'Physical examination abnormal', 'Tonsillar hypertrophy']",1,MODERNA,IM 924111,,20.0,F,Flu Sx HA,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/04/2021,6.0,WRK,,,,,,"['Headache', 'Influenza']",UNK,MODERNA, 924112,WI,102.0,F,Swelling to right side of neck and lymph nodes- hospice practitioner notified. No new orders received.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,SEN,,,,,,"['Lymphadenopathy', 'Swelling']",1,MODERNA,IM 924113,CA,47.0,F,"Swollen , warm to touch with redness around the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,WRK,None,None,None,,None,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SC 924114,WA,31.0,M,"Received shot at 10:40. At 11:15 developed dizziness with nausea and tingling in arms. Blurry vision from 11:30-11:40. Nausea progressed to vomiting at 11:55. Nausea and vomiting persist at 13:20. Tingling in arms has improved but still present. Dizziness improved but still present. Body aches developed throughout most of body, worst in neck.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,No meds,None,None,,No allergies,"['Dizziness', 'Nausea', 'Pain', 'Paraesthesia', 'Vision blurred', 'Vomiting']",1,MODERNA,IM 924115,AZ,32.0,F,The following day I had uncontrollable muscle spasms on my face. Twitching. Etc,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,None,None,Type 2 diabetes,,None,"['Muscle spasms', 'Muscle twitching']",1,PFIZER\BIONTECH,SYR 924116,MA,44.0,F,"arm became red , seen in urgent carevand pt was told to place ice on it and take motrin and the swelling went away in24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/26/2020,2.0,OTH,no,no,no,,no,"['Erythema', 'Peripheral swelling']",UNK,MODERNA,IM 924117,CO,29.0,F,"Redness, swelling and itching at injection site, just started today",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,PVT,"Claritin, Sudafed, Buspirone, Norethindrone",none,"Asthma, recently gave birth August 31st",,pollen,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 924118,MI,44.0,F,"immediate nausea, headache, dizziness (feeling of motion sickness) and arm pain, tiredness. ongoing headaches, fatigue, dizziness and nausea on and off every day",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,PVT,"Trulicity, Toujeo, Zoloft, ibuprofen",,"Diabetes Type II, Anxiety, Depression",,Sulfa,"['Dizziness postural', 'Fatigue', 'Headache', 'Immediate post-injection reaction', 'Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 924119,ME,37.0,F,Presented in ED for rapid onset rash with itching from L shoulder to above elbow . ED noted this as probable COVID vaccine reaction and prescribed Claritin 10mg daily as needed for itching. Use cool compresses as needed.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,OTH,Levonorgest-Eth Estrad 91-Day (Daysee) 0.15-0.03 &0.01 MG Tab levoTHYROxine 88 MCG Tab Omega-3 Fatty Acids (FISH OIL) 1000 MG Cap Prenatal Vit-Fe Fumarate-FA (PRENATAL MULTIVITAMIN) TABS CALCIUM PO,none known,none known,,none known,"['Pruritus', 'Rash']",1,MODERNA,IM 924120,WA,36.0,F,"For first two days following shot I had redness (2-3 in diameter circle) surrounding injection site, as reported in v-safe. Then was clear until day 8 following shot, redness reappeared along with mild itching. Redness is again 2-3 in diameter circle surrounding injection site. Redness still present today, day 9.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,UNK,Prozac 30 mg daily Vitamin D 2000 IU daily Women?s one-a-day vitamin daily,None,,,PPD forearm placement causes redness at site for extended period of time. No history of TB.,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 924121,SD,49.0,M,"Fever, feeling flushed, tunnel vision, light headedness, headache/pressure, chills, elevated pulse rate, elevated blood pressure. Took migraine medication for headache, outcome unknown",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,"Lisinopril, Amlodipine",none,Hypertensive,,NKA,"['Chills', 'Dizziness', 'Flushing', 'Head discomfort', 'Headache', 'Heart rate increased', 'Pyrexia', 'Tunnel vision']",1,PFIZER\BIONTECH,IM 924122,CT,35.0,M,"Pain in injection site, body aches, headache and nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,UNK,Losartin Singular,None,Mild HBP,,No,"['Headache', 'Injection site pain', 'Nausea', 'Pain']",1,MODERNA,IM 924123,NY,41.0,F,Was very itchy and then got red and swollen,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,WRK,,,,,,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA,SYR 924124,AZ,65.0,F,"Left upper arm (injection arm) became itchy, erythematous, swollen and hot",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,WRK,none,none,osteoarthritis hands,shingrex #2,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 924125,VA,51.0,F,"States that she has experienced generalized itching since receiving first dose of COVID-19. Also states that she has noticed her sclerea becoming yellow and skin ""jaundice"" in color.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/22/2020,4.0,PVT,,,,,,"['Ocular icterus', 'Pruritus', 'Yellow skin']",1,PFIZER\BIONTECH,IM 924126,MI,84.0,F,resident expired 1/1/2021,Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,SEN,"Singulair, lopressor, pepcid, omeprazole, lasix, albuterol, azelastine eye gtts, calcium, eliquis, prozac, terazosin, magnesium oxide, potassium","Low blood pressure requiring medication changes. Sent to ER on 1/1 with low b/p sent back same day, heart failure. Family requests comfort measures only.","CHF, Heart Failure, hypertension, Atrial-fibrillation, Crohns disease.",,"Asa, Cardizem, delsyn, doxycycline, levaquin, motrin, prevacid, vicodin",['Death'],1,MODERNA,IM 924127,,28.0,F,"Had 2nd vaccine at 1pm yesterday (01/05). 8pm started to had fatigue, body ache. At 10pm got worse severe headache, fatigue, bodyache, 99-100.6. 10am this morning (01/06). Headache was severe that staff had to take medicine and could not sleep well.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,UNK,,,,,,"['Body temperature increased', 'Fatigue', 'Headache', 'Pain', 'Poor quality sleep']",UNK,PFIZER\BIONTECH, 924128,MA,53.0,M,"Last night experienced itchiness on the back around 5:00 for a few hours. Chills, body aches and pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PUB,omeprazole,no,Asthma,,no,"['Chills', 'Pain', 'Pruritus']",1,MODERNA,IM 924129,AK,74.0,M,Pt. was given flu shot in same arm at same visit as Moderna Vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,,,PVT,Was given Fluarix Vaccine at same time as Moderna Covid-19 injection,,,,,['Contraindication to vaccination'],1,MODERNA,IM 924130,,54.0,F,Localized erythema,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,,,,,,['Erythema'],UNK,MODERNA, 924131,PA,79.0,M,"Hypoxia, epilepsy seizures",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,,N/a,N/a,,"Beef,","['Epilepsy', 'Hypoxia', 'Oxygen saturation decreased']",1,PFIZER\BIONTECH,IM 924132,CA,39.0,F,"On day 8 post-injection, a large, annular, serpiginous red rash developed at the site of the injection and over the entire deltoid skin area, with some central clearing.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,Lutera OCP Flonase nasal spray,None,"GERD, migraine headaches, seasonal allergies",,Pencillin allergy (full-body urticaria),['Injection site rash'],UNK,MODERNA, 924133,CA,54.0,F,"Sever arm pain had difficulty sleeping due to this. No redness at injection, difficulty moving arm following day. Pt tried OTC Tylenol which did not relieve pain. Advised to apply ice packs and to try Ibuprofen for pain and Benadryl to help with sleep. Also reported feeling a bit dizzy and having chills and throat pain. Advised to continue to treat symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PUB,Lisinopril,none,HTN,,NKDA or allergies to food or other products,"['Chills', 'Dizziness', 'Insomnia', 'Mobility decreased', 'Oropharyngeal pain', 'Pain in extremity']",1,MODERNA,IM 924134,RI,48.0,F,"Approximately, on day 6-7, left antecubital swelling and tenderness. Over next few days, gradual worsening pain and edema of the area and inner aspect of left upper extremity. Pain felt into the left axilla, Focal redness over ventral aspect of elbow. First, I did not relate it to vaccine and was not sure of etiology. Day 13: linear red indurated/ palpable ropy area , markedly tender in proximal forearm. Worse swelling and pain. Day 14: red Line extends upward towards axilla Day 15: Saw primary care physician Recommended antibiotics and Aspirin, warm compresses and ordered ultrasound. Findings were consistent with lymphadenitis and lymhpangitis",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/26/2020,5.0,PVT,Effexor Levothyroxine Vit D,,,,Pitted fruits,"['Axillary pain', 'Bursitis', 'Lymphadenitis', 'Lymphangitis', 'Oedema peripheral', 'Pain in extremity', 'Peripheral swelling', 'Ultrasound Doppler abnormal']",1,PFIZER\BIONTECH,IM 924135,NJ,59.0,M,"I experienced a fever of 100.4, 24 hours after the injection, accompanied by overall muscle aches, headaches, and difficulty sleeping. The fever was gone within 36 hours, but the other symptoms persisted. My spouse, who also had Covid-19 at the same time that I did experienced the same symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,"Synthroid (175), levothyroxin (10), Glucosamine Chondroitin, Eye Health Vitamin,",I was infected with Covid-19 on 11/27 but had mild symptoms and felt better by 11/30,Hypothyroidism (treated and well controlled),,Dust mites,"['Headache', 'Insomnia', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 924137,NY,43.0,F,8-10 hours after vaccine she noticed a rash on both hands-left worse than right. No other problems.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,['Rash'],1,MODERNA, 924139,PA,36.0,F,No symptoms within 15 minutes of monitoring post vaccination. Reported 1/6/2021. Went home and noticed LEFT arm was itchy. Woke up in the morning with hives running along her left arm. Took an antihistamine and hives reduced to red dots with some residual itching. no other symptoms. no respiratory issues.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,WRK,unknown,Unknown,Unknown,,NKDA,"['Pruritus', 'Rash macular', 'Urticaria']",1,PFIZER\BIONTECH,IM 924140,NE,83.0,F,"APPROXIMATELY 1 HOUR POST VACCINATION, DEVELOPED TIGHTNESS AROUND HEAD ""RUBBER BAND AROUND HEAD"". RESOLVED AFTER ABOUT 1 HOUR.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,,,,,,['Tension headache'],1,PFIZER\BIONTECH,IM 924141,IL,49.0,F,Chills Muscle and joint aches Fever Nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Lexapro 10 mg QHS Clonazepam .5 mg QHS Wellbutrin 150mg QAM Maxalt 10 mg PRN Advil PRN,Tested positive for Covid 12/01/2020,,,PCN-Rash,"['Arthralgia', 'Chills', 'Myalgia', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,IM 924143,MN,37.0,F,"All over body rash, itchy, sweaty, hot, cool and clamy skin, pulse 110-120bpm,lasted about 1-1 1/2 hours. No treatment. Did deep breathing and took a shower. Symptoms resolved on their own. I did have a very sore arm for about three days after the administration of the vaccine. Redness to the injection site with a knot under the injection site for three days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,escitalopram 20mg; setlakin 0.15mg/0.03mg,none,asthma,,celexa; maple pollen,"['Cold sweat', 'Feeling hot', 'Hyperhidrosis', 'Injection site erythema', 'Injection site nodule', 'Pain in extremity', 'Pruritus', 'Rash']",1,MODERNA,SYR 924144,TX,35.0,F,"RASH TO FACE AND ARM, TROUBLE BREATHING, SHAKING",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,NONE,NONE,NONE,,SHELLFISH,"['Dyspnoea', 'Rash', 'Tremor']",1,MODERNA,IM 924146,KY,36.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"Synthroid 125mcg, calcium, probiotic, vitamin C",None,Hashimotos thyroiditis,,None,['Headache'],UNK,MODERNA,SYR 924147,CT,56.0,F,Swelling of the face and itchy rash on face and forearms.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PUB,,,,,,"['Rash', 'Rash pruritic', 'Swelling face']",1,MODERNA,IM 924148,MI,46.0,F,RED SQUARE ON ARM AT VACCINATION SITE 2 WEEKS POST IMMUNIZATION. NO TREATMENT . RESOLVED,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/31/2020,14.0,PVT,"VIY D , PROVENTIL, ZYRTEC, GARLIC, ADIPEX SINGULAR.",NONE,"ASTHMA , HYPERLIPIDEMIA, SEASOMAL ALLERGYS",,"DILAUDID , HYDROMORPHONE.",['Injection site erythema'],1,PFIZER\BIONTECH,IM 924149,MT,38.0,F,"Left neck pain and intense left sided jaw pain (parotid gland area). The pain made it difficult to open mouth for 2 weeks, but it started getting better after week 1. The pain went into left ear.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/20/2020,2.0,UNK,,,,,,"['Ear pain', 'Neck pain', 'Pain in jaw']",1,PFIZER\BIONTECH,IM 924150,WV,61.0,F,Sore arm starting about 2 days after vaccination lasting for 48 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,PVT,zoloft;,none,none,sore arm,compazine,['Pain in extremity'],1,PFIZER\BIONTECH,IM 924151,CA,51.0,F,"This morning noticed long strip of a rash on both arms on both side. Lethargy, dizziness, weakness, rapid heart beat.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Zocor, Gabapentin, fish oil, vitamin D, multivitamin, immunetty.",no,Tremors.,,"Erythromycin, Primidone","['Asthenia', 'Dizziness', 'Heart rate increased', 'Lethargy', 'Rash']",1,MODERNA,SYR 924152,NY,32.0,F,"Patient developed tongue swelling and facial swelling approximately 25 minutes after vaccination Patient was administered prednisone 20 mg po, benadryl 25 mg po and Epinephrine 0.3 mg IM",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2020,01/06/2021,366.0,PVT,Norethindrone-ethinyl estradiol 1/20 daily Tretinoin 0.05% cream,None,Acne Seborrheic dermatitis Eczema,,"Shrimp, Salmon, Dogs, Cats, Trees, Pollen","['Swelling face', 'Swollen tongue']",1,MODERNA,IM 924153,LA,27.0,F,"sore injection site the next day, next day at 10am began experiencing aches in my joints and achey muscles all over, mild headache, fatigue. At around 1pm experienced chills and fever. Experienced 3 episodes of diarrhea that started about 5 hours after the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Probiotic, prenatal vitamins",No,None,,"Shellfish, dogs, cats, horses","['Arthralgia', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 924154,KY,23.0,F,Called HD at approx 3:20 pm and states that she had itching at injection site shortly after injection. States that she now has a rash and itching extending down both arms; worse on the left arm. Denies any other symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,unknown,denies,unknown,,unable to recall,"['Injection site pruritus', 'Pruritus', 'Rash']",UNK,MODERNA,IM 924155,AK,44.0,F,Pt. given Flu shot Fluarix Quad at same visit and in same arm as Covid-19 Moderna vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,,,PVT,,,,,,['Contraindication to vaccination'],1,MODERNA,IM 924156,,55.0,F,Pt experienced rash and itching on arms and legs from 12/23-12/27. Took Benadryl to improve symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/23/2020,1.0,PVT,,,,,,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 924157,LA,49.0,F,"A couple of hours after the vaccine, I began to have extreme muscle pain, both in the left arm and in my other arm, back. I became extremely fatigued and felt lethargic. I felt flushed and slightly nauseated, but mostly I felt body pain and extremely tired. This continued through the evening and night. In the morning of 1/6/21, I felt better, but today I still have severe muscle pain in both arms and shoulders and back and neck and I am still fatigued, with some loss of appetite.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,UNK,Lexapro 20 mg Levothyroxine 50 mcg Spirinolactone 100 mg,none,hypothyroidism but treated so thyroid levels are good,,none,"['Decreased appetite', 'Fatigue', 'Flushing', 'Lethargy', 'Myalgia', 'Nausea']",1,PFIZER\BIONTECH,IM 924158,WA,48.0,F,"Caregiver started feeling flush, light headed, tunnel vision and was escorted to lay down. BP 196/102, HR 119 O2 100%. No shortness of breath. No hx of any reaction. Just had a snack, came to work for vaccine and to work nights. 1836 BP 187/104 HR 122 O2 99%, 1846 BP 175/93 HR 97 O2 99%, started having a headache and nausea and dry mouth. Water provided 1903 BP 177/91 HR 97 still flushed but reduction in dizziness 1949 BP 141/84 HR 85, improved all sx, still felt off but was able to stably walk around. Called husband for transport home, did not work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,None that was stated,None that was stated at the time,None that was stated,,NKA,"['Dizziness', 'Dry mouth', 'Feeling abnormal', 'Flushing', 'Headache', 'Impaired work ability', 'Nausea', 'Tunnel vision']",1,MODERNA,IM 924159,IN,46.0,F,24 hours after receiving COVID vaccine I began having symptoms of vertigo and dizziness in my L ear. Vaccination was given in the L deltoid.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,None,"Cough, congestion",None,,None,"['Dizziness', 'Vertigo']",1,PFIZER\BIONTECH,IM 924160,PA,50.0,F,"approximately 10 minutes after receiving the vaccine, developed hot flushed feeling that began in arm and spread to entire body. Began sweating and had palpitations with tachycardia. Also developed teeth chattering. Felt dizzy and slightly short of breath. Symptoms lasted approximately 5 minutes and resolved at the same time that I was given IM Benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,"Lexapro, b complex, vitamins A, D, C, B1, Zinc, biotin, Iron, Sudafed",none,History of gastric bypass surgery. anxiety,,"hazelnut, Brazil nuts, mushrooms and Lortab","['Chills', 'Dizziness', 'Dyspnoea', 'Hot flush', 'Hyperhidrosis', 'Palpitations', 'Tachycardia']",1,MODERNA,IM 924161,KY,23.0,F,"About 15 minutes after receiving vaccine, patient started to have chest pain and high blood pressure. Her blood pressure was 170/110 at 2:30 and then at 2:40 it was 130/110. She was feeling better and pulse was good around 2:45pm. She did take a Benadryl that was offered. She was not having any trouble breathing or dizziness. Patient went by EMS to get checked out and was cleared by the hospital staff.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,SEN,,none,none,,none,"['Chest pain', 'Electrocardiogram normal', 'Hypertension']",1,PFIZER\BIONTECH,IM 924162,NE,35.0,F,"AS REPORTED BY PATIENT: Monday 12-28 evening I begun to get chills and body aches, the next morning when waking up I felt like a truck hit me. Starting Tuesday morning, for three days, I got calf/feet cramps that were non-stop. I did call my doctor and got lab work done on 12-31. This lab work showed some kidney values that were off. Starting Sunday my legs and feet swelled up. I had a routine MS appointment on Monday and they stated since there is no data for folks with MS and the vaccine that they cannot rule out the vaccine is playing a role in some of this along with the IVIG. I did follow up with my primary care doctor on Tuesday and they re did lab work as well as did a ultrasound to rule out blood clots. She did state she felt like it was the perfect storm between the COVID vaccine and then the Immunoglobins that I am on. She suggested I download the app for CDC and report those items as well. The doctors are still suggesting I get the 2nd shot just have to do some things prior to the second shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,SEN,,,,,,"['Chills', 'Feeling abnormal', 'Laboratory test', 'Muscle spasms', 'Pain', 'Peripheral swelling', 'Ultrasound scan']",1,PFIZER\BIONTECH,IM 924163,TX,36.0,F,"On 1/6 at approximately 9am hour, I noticed joint pain in my fingers while typing, muscle soreness in my upper back, a headache, and a slightly sore throat. It quickly went down hill with a fever, chills, worsening joint and muscle pain everywhere, nausea, severe fatigue, worsening sore throat, tingling and numbness in all extremities at random locations. It is now 3pm, about 21 hours since vaccination-fever has broken once (I took ibuprofen at 2pm) but returned but not as high, and severe headache with light sensitivity. The joint pain and numbness has faded but I am left with severe muscle soreness, like I was in a car accident. Oh and I lost taste sometime today. Also I had injection site pain for both doses, starting the morning after.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Vyvanse. Generic Zyrtec.,None,Depression and ADHD,,Sulfa and cipro drugs (full body rash). Tramadol and Percocet (anafloid),"['Ageusia', 'Arthralgia', 'Back pain', 'Chills', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Injection site pain', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Pain in extremity', 'Paraesthesia', 'Photophobia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924164,,48.0,F,patient received vaccine and shortly became warm and felt her arms were getting red and splotchy. Patient taken to ER and was given PO Benadryl 50mg and observed. Discharged 2 hrs later,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/18/2020,0.0,UNK,,,,,,"['Feeling hot', 'Rash']",1,PFIZER\BIONTECH,IM 924165,NY,34.0,F,"Swollen arm, redness, itching",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/02/2021,9.0,PVT,None,Asymptomatic covid 19,None,,Sensitive skin,"['Erythema', 'Peripheral swelling', 'Pruritus']",1,MODERNA,IM 924166,MO,59.0,F,"Total body and joints pain. On a scale of 1 to 10, most of the time 6 to 8. And also very weak with no stamina. Lasted until 12 /25/2020. Felt horrible like I also had a fever. Although I never did run a temp.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/20/2020,2.0,PVT,Evista Oxycodone Motrin MVI Calcium vit D,Knee replacement 10/16/2020,,,PCN,"['Arthralgia', 'Asthenia', 'Feeling abnormal', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 924167,WA,48.0,F,"PRIMARY EVENT 12/26/20, 48 yo well controlled asthma, got injection at 110p, sat in waiting area, then about 118p developed tickle in the throat, sensation like ?closing?. Denies stridor, wheezing, sob. Doctor came by and assessed her, and then was given PO Benadryl 50mg. Symptoms didn?t worsen, and over time improved. Went home around 230, throat was no longer tingling. SECONDARY EVENT Reported a week of night sweats myalagias, as well as rigors (12/26 - 1/2/21). Has had persistent axillary LAD, but more recently developed inquinal LAD as well. Non tender, just noticeable. As of 1/6/21, no more sweats, no real fevers. But reports ongoing ?chills? and mild HA. She is still working and not incapacitated.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,WRK,"doxycycline, levothyroxine, botox",,well controlled asthma,,"Amoxicillin, Gatifloxacin, Erythromycin, Sulindac","['Chills', 'Lymphadenopathy', 'Myalgia', 'Night sweats', 'Throat irritation']",1,MODERNA,IM 924168,MN,60.0,F,"Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,WRK,Venlafaxine ER 37.5mg (x2) AM/PM Vitamin C 1000mg (x2) Calcium 600 with vitamin D3 D3 125mcg (5000 IU),mild cold mid December,Anxiety/Depression Vitiligo,,An antibiotic (I can't remember its name) corn,"['Arthralgia', 'Body temperature increased', 'Chills', 'Erythema', 'Headache', 'Impaired work ability', 'Influenza like illness', 'Lymphadenopathy', 'Malaise', 'Mobility decreased', 'Nausea', 'Oral herpes', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 924169,ME,24.0,F,"dry cough, sore throat, left eye schera injection (mild), left rhinnorhea within 15 minutes of vaccination. Self resolve. mild in nature",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,none,no,none,,none,"['Cough', 'Eye disorder', 'Oropharyngeal pain', 'Rhinorrhoea']",2,PFIZER\BIONTECH,IM 924170,MO,26.0,F,"12/24/2020 I started with a wooshing feeling immediately after the vaccine, I sat down for 15 mins and felt dizzy so I stayed another 15 mins. BP was 140 and abnormal I had juice and felt better and went back to work and I felt tingling all over my body and fainty and my legs felt very heavy. I went upstairs and my BP was 160's and heart rate was 120 and I went to the ER. My face appeared to be swollen and my tounge felt tingly and I was given fluids and benadryl and solumedrol . My BP was in the 140's I went home to get rest and I still felt tingly for a couple days. The next day I felt feverish my arm was sore and I went to doctor gave me a rx for anxiety and I stayed home and rested from work for a few days. My tinglyness subsided after the medication",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,"birth control yazmin, bactrim for UTI, womens multivitamin, fiber",UTI a week prior,no,,amoxocillin and cipro floxan,"['Anxiety', 'Blood pressure abnormal', 'Dizziness', 'Electrocardiogram normal', 'Immediate post-injection reaction', 'Impaired work ability', 'Laboratory test normal', 'Limb discomfort', 'Pain in extremity', 'Paraesthesia', 'Paraesthesia oral', 'Pyrexia', 'Sensory disturbance', 'Swelling face']",1,MODERNA,SYR 924171,LA,13.0,F,"Late at night patient began having chills and extreme muscle pain all over her body, sore throat, nausea, extreme fatigue. She also had a fever of 102.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,none,none,none,,none,"['Chills', 'Fatigue', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924172,SC,29.0,F,"Welps at injection sight, axillary lymph node swelling, swollen lymph nodes in neck and shoulder pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,,,,,,"['Arthralgia', 'Injection site mass', 'Lymphadenopathy']",1,MODERNA,IM 924173,MI,41.0,M,I started having intermittent chest pain moderate in intensity and palpitations.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,12/23/2020,12/25/2020,2.0,PVT,"metoprolol succinate XL 25 mg 24 hr tablet Commonly known as: Toprol XL Learn more Take 1 tablet (25 mg total) by mouth daily. cholecalciferol 125 mcg (5,000 unit) tablet Commonly known as: Vitamin D3 ferrous sulfate 325 mg (65 mg iron)",None,"Coronary Artery Disease, Asthma",,None,"['Catheterisation cardiac', 'Chest pain', 'Electrocardiogram', 'Palpitations', 'Troponin']",1,PFIZER\BIONTECH,IM 924174,,34.0,F,"Pt received dose and within a few minutes (while in observation) started coughing and complaining of chest tightness. Sx progressed to audible wheeze and patient was give Epinepherine 0.3mg IM X1 and was taken via wheelchair to ER. Pt received second dose of Epi via (ER) orders. Pt was also given solumedrol125mg, diphenhydramine 50mg, famotidine (injectable). Pt was also give albuterol via nebulizer. After full evaluation it was determined pt was having acute asthma exacerbation and anxiety. About two hours after incident - plan was to observe pt for another hour and discharge home with oral steroid.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,history of Asthma,history of asthma,,Pt does not know exactly which medication - but reports anaphylaxis to either morphine or penicillin (injectable),"['Anxiety', 'Asthma', 'Chest discomfort', 'Condition aggravated', 'Cough', 'Wheezing']",2,PFIZER\BIONTECH,IM 924175,OK,35.0,F,"swollen redness 2 in in diameter around injection site, day 2-4 after swollen redness 1/2 in in diameter around injection site, day 8 after",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,WRK,Heather norethindrone tablets Lisinopril Advil Elderberry Gummies,,High Blood Pressure,,,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,SYR 924176,NY,55.0,F,Syncopal episode went to ER and required stitches,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/01/2021,2.0,PVT,,,,,,['Syncope'],UNK,PFIZER\BIONTECH,IM 924177,NY,41.0,F,"Mild erythematous patch/rash minimally pruritic. No other systems involved. Rash was anterior chest, not at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Trintellix, Alprazolam, Hydroxyzine, Omeprazole, Spironolactone, Quetiapine, Simvastatin",None,"Anxiety, Depression, GERD, Dyslipidemia, HTN, Vitamin D deficiency",,Ramipril/Ace inhibitors,"['Rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 924178,GA,40.0,F,axillary lymph node swelling and shoulder pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,PVT,none,none,,,none,"['Arthralgia', 'Lymphadenopathy']",1,MODERNA,IM 924179,NJ,59.0,F,"Fever 102 > 48 hrs, rigors, pan muscle weakness & pain. I missed 3 days of work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/04/2021,3.0,PVT,"Levothyroxine, metoprolol, buspirone, estrogen, omeprazole, gabapentin, rosuvastatin, vitamin d.",I had SEVERE COVID in April.,"Covid related symptoms: irregular heart rate, flashing visual disturbance.",,Nka,"['Chills', 'Impaired work ability', 'Muscular weakness', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 924180,AK,57.0,F,"10 minutes after receiving vaccine, developed flushing and tingling of tongue. 45 minutes later, developed nausea. 1 hour and 45 minutes after vaccine, developed laryngitis. Sent to ED for evaluation and treatment. Received Solumedrol and Pepsid in ED with improvement. Discharged home by or before 8pm with resolution of laryngitis and other symptoms. Reports ""feeling great"" this a.m.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Meloxicam, clobetasol propiaonate, dotti-estrogen, ibuprofen, albuteral-advair, epi pen (as needed)",None,"Asthma, leukocytoclastic vasculitis, arthritis-in diagnostic process to determine if it is RA or psoriatic, psoriasis, Morton neuromas left foot.",Influenza - unknown details,"Food allergies: almonds, stone fruits, shellfish, stays away from gluten - sensitive with digestive issues. Med allergies: Iodinated contrast media, Phenothiazines, sympathomimetic agents, penicillins, cephalosporins, macrolide antibiotics, carbaenems,antihistamines - alkylamine, antihistamines - ehylenediamine, antihistamines - ethanolomine, antihistamines - piperidne, Serotonin SHT-3 Antagonists, Opiods - Meperidine and related, morphine, codeine, antinausea meds, benadryl oral, cat gut sutures, Stadol, Sudafed, Sulfa, adhesive bandage, morphine conentrate","['Flushing', 'Laryngitis', 'Nausea', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 924181,,,F,Swollen red spots numbness pain down by breast on left side soreness on armpit on left side,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/04/2021,7.0,UNK,,,,,,"['Axillary pain', 'Breast pain', 'Hypoaesthesia', 'Swelling']",1,MODERNA,SYR 924182,,29.0,F,hives tickle in throat 1 hour post vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['Throat irritation', 'Urticaria']",1,PFIZER\BIONTECH,IM 924183,PA,60.0,F,Dizziness for 15 minutes,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,SEN,"Atorvastatin, Trulicity, Lantus, Synthroid, Paxil, atenolol, Metformin, Aspirin, Vit D, B complex, Magnesium, Vit C, Zinc.",None,"Diabetes, Hypothyroidism, Hypercholesterolimia",,No known allergies,['Dizziness'],UNK,PFIZER\BIONTECH,IM 924184,NE,35.0,F,"DESCRIPTION THAT FOLLOWS IS FROM PATIENT: Monday 12-28 evening I begun to get chills and body aches, the next morning when waking up I felt like a truck hit me. Starting Tuesday morning, for three days, I got calf/feet cramps that were non-stop. I did call my doctor and got lab work done on 12-31. This lab work showed some kidney values that were off. Starting Sunday my legs and feet swelled up. I had a routine MS appointment on Monday and they stated since there is no data for folks with MS and the vaccine that they cannot rule out the vaccine is playing a role in some of this along with the IVIG. I did follow up with my primary care doctor on Tuesday and they re did lab work as well as did a ultrasound to rule out blood clots. She did state she felt like it was the perfect storm between the COVID vaccine and then the Immunoglobins that I am on. She suggested I download the app for CDC and report those items as well. The doctors are still suggesting I get the 2nd shot just have to do some things prior to the second shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,SEN,,,,,,"['Chills', 'Laboratory test', 'Muscle spasms', 'Oedema peripheral', 'Pain', 'Ultrasound scan']",1,PFIZER\BIONTECH,IM 924185,IL,47.0,F,"Chills, fever, general weakness & fatigue, sweating",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Zyrtec; vit D, Vit C, Vit B12",,,,NKA,"['Asthenia', 'Chills', 'Fatigue', 'Hyperhidrosis', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924186,MI,91.0,F,Resident expired 1/3/21,Yes,01/03/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/03/2021,4.0,SEN,"aldactone, lasix, aspirin, tylenol, potassium, spiriva",Covid positive previous with no s/s poor appetite Chronic wound right leg,"alzheimers dementia, COPD , DM- type 2",,"Codeine, Penicillin, Sulfa",['Death'],1,MODERNA,IM 924187,TN,32.0,F,"PATIENT DEVELOPED ERYTHEMA, DIFFUSE PRURITUS, AND ITCHINESS WITHIN THE 20 MINUTE POST INJECTION. SHE RECEIVED 50 MG OF BENADRYL IM, AND 20 MG OF FAMOTIDIN ORAL, AND AFTER 30 MINUTE TREATMENT, THE REACTION SUBSIDED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Erythema', 'Pruritus']",1,MODERNA,IM 924188,AZ,38.0,F,"Migraines, right side of face swollen, nausea, tingling",Not Reported,,Not Reported,Yes,,Not Reported,N,12/26/2020,12/26/2020,0.0,OTH,no,no,no,,no,"['Computerised tomogram', 'Migraine', 'Nausea', 'Paraesthesia', 'Swelling face']",1,PFIZER\BIONTECH,IM 924189,NY,60.0,M,SIRVA due to injection being delivered too high and delivered to shoulder capsule instead of deltoid muscle.vaccine was delivered One centimeter form the Acromion.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,"lisinopril 5mg daily, 81 grain aspirin, vitaminD 2000u, probiotic",none,Hypertension controlled with medication,,penicillin,"['Injection site pain', 'Periarthritis', 'Product administered at inappropriate site', 'Shoulder injury related to vaccine administration']",1,MODERNA,IM 924190,,78.0,F,"After vaccine administration, pt experienced severe diarrhea with incontinence.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/16/2020,0.0,PVT,,,,,,"['Diarrhoea', 'Incontinence']",1,PFIZER\BIONTECH,IM 924191,MA,36.0,F,"Fatigue, Week later, itchy at inj site. Next morning warm redness, irritated blotch. 2inx2in area.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,WRK,"Apri, Vitamins.",headache/ sinus infection,no,,no,"['Fatigue', 'Injection site erythema', 'Injection site pruritus', 'Injection site warmth', 'Rash macular']",1,MODERNA,SYR 924192,PA,25.0,F,"History of vasovagal responses with immunizations. Occurred 8 minutes post injection. Gave juice and crackers. 0818 BP 73/59 placed on litter in trendelenberg position. 0825 113/69, 0826 BP 116/80 standing. At 0834 BP 127/78. Symptoms improved. Released from clinic. 30 minutes total observation time.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,WRK,Unknown,unknown,unknown,,Not on file,['Blood pressure decreased'],1,PFIZER\BIONTECH,IM 924193,GA,67.0,M,Swelling and welps at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,PVT,,,,,,"['Injection site reaction', 'Injection site swelling', 'Urticaria']",1,MODERNA,IM 924194,NY,29.0,F,"Fever 100.2 chills,Headache, Joint body ache left armpit swelling dime size symptoms started 12 hours later after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Oedema peripheral', 'Pyrexia']",1,PFIZER\BIONTECH, 924195,TX,27.0,F,"EE report symptoms of left arm pain, fever of 101 , chills, and mild body aches. Treatment include Tylenol with symptom improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Chills', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924196,WI,53.0,F,"1) itchy arms and legs starting a few minutes after injection, resolving within the half hour 2) allergic dermatitis (id reaction) on my fingers about 30 hours after the injection (presumed type 4 hypersensitivity reaction to PEG)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,claritin,None,None,,"PEG, colophony, thimerosal, gold","['Dermatitis allergic', 'Hypersensitivity', 'Pruritus', 'Reaction to preservatives']",1,MODERNA,IM 924197,OK,40.0,F,"Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. Rash noted initially on arms, chest, and back. Palms of hand became very red. Shortly after, she became hoarse, and hives were noted on chest and neck.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None known,Patient denies illness.,None,After initial COVID vaccination on 12/16/2020 patient experienced arm redness and swelling.,Phenergan,"['Anxiety', 'Chest discomfort', 'Dysphonia', 'Erythema', 'Heart rate increased', 'Rash', 'Throat tightness', 'Urticaria']",2,PFIZER\BIONTECH,IM 924198,TX,60.0,F,"HIVES, RASH ON VACCINATION ARM, ANAPHALXIS, DIZZINESS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,UNKNOWN,NONE,UNKNOWN,,"SHELLFISH, IODINE, IVP CONTRAST","['Anaphylactic reaction', 'Dizziness', 'Urticaria', 'Vaccination site rash']",1,MODERNA,IM 924200,,39.0,F,15 to 30 minutes after vaccination experienced itchy throat and tongue and dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,UNK,,,,,,"['Dizziness', 'Throat irritation', 'Tongue pruritus']",UNK,PFIZER\BIONTECH,IM 924201,MD,94.0,M,"Patient tolerated the vaccine well with no apparent side effects. Ten days later awoke 12:30 AM with severe chest and upper back pain, presented to Med Center where he was found to have an Acute Coronary Syndrome. Transferred to Medical Center where he underwent successful PCI with two drug eluting stents for a 99% mid-LAD stenosis",Not Reported,,Yes,Yes,3.0,Not Reported,Y,12/24/2020,01/03/2021,10.0,PVT,Prilosec 20 mg qd Lipitor 20 mg qd Levothyroxine 100 mcg/d (incr from 88 for TSH 4.78 8/26/20) Ativan 0.5-1 mg hs prn 10-15/month EC ASA 2 x 81 mg qd,Adjustment disorder/grief reaction,"PAST MEDICAL HISTORY Surgical- T&A age 5 Appendectomy age 8 or 9 Rhinoplasty for deviated septum x 2 1960s Gas gangrene Right Leg- debridement 1972 Right inguinal hernia ~2002 Bilateral Cataracts/IOLs 2014 Umbilical Herniorrhaphy 2020 Medical- Hepatitis and possible malaria 1944 Hyperlipidemia GERD/Barretts- Lower GI bleed hospitalized ~1994; no Tx Hemorrhoids Anal fistula Herpes zoster Nov 2012 Left Trigeminal Hypothyroidism Dec 2013 (fatigue, elevated TSH 5.81, fT4 0.7) Childhood Diseases- Measles- yes; Mumps- yes; Rubella- ?; Varicella- yes; Rheumatic Fever- no; Pertussis- yes Habits- Tobacco- quit 1950; Alcohol- 0-2 night; Drugs- no Immunizations- Td- 3/08, 8/22/19; TdaP- ; Influenza- 8/25/20; Pneumovax- yes <2003, 3/08; PCV13- 12/19/14; Hep A- ; Hep B- ; Zostavax- 3/07; Shingrix- 2/21/18, 10/30/18; Covid 19 (Moderna) 12/24/20",,PCN- rash? Bee sting- swelling (has Epipen) (no hx food or latex allergy),"['Acute coronary syndrome', 'Back pain', 'Catheterisation cardiac abnormal', 'Chest pain', 'Coronary arterial stent insertion', 'Coronary artery stenosis', 'Echocardiogram abnormal', 'Ejection fraction decreased', 'Electrocardiogram abnormal', 'Percutaneous coronary intervention', 'Troponin increased']",UNK,MODERNA,IM 924203,IL,49.0,F,Headache for 4 days following vaccine. On day 5 following vaccine developed hives on arms and chest.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/21/2020,2.0,PVT,,,,,,"['Headache', 'Urticaria']",1,PFIZER\BIONTECH,IM 924204,WI,41.0,F,Bad heartburn type symptoms. Not normal for me. Since 0900 1-6-2021 No treatment taken yet,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/06/2021,5.0,PVT,None,None,Gastroparesis Fibromyalgia,,"Compazine, erythromycin, lactose",['Dyspepsia'],1,MODERNA,IM 924205,NH,14.0,F,Patient given COVID-19 Moderna vaccine at age of 14 years old. Pharmacist (myself) realized patient was under the age of 18 years after administering the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,unkown,unknown,unknown,,none per patient,['Product administered to patient of inappropriate age'],1,MODERNA,IM 924206,,37.0,M,"Patient developed hard, swollen area around injection site 1 week after injection. Area was very hot to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,PVT,,,,,,"['Injection site induration', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA, 924207,OK,46.0,F,"Injection site pain, redness at injection site, then followed by chills and fever. Injection site swelling about 2"" with fever and redness at injection site - lasted about 5 days. Also was feeling unwell, tiredness & muscle pain for a few days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,Keppra,,,,"Benedryl, morphine","['Chills', 'Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Malaise', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 924208,IL,58.0,M,"Shortness of breath, fever, fatigue",Not Reported,,Not Reported,Yes,6.0,Not Reported,U,12/30/2020,12/31/2020,1.0,SEN,,,,,,"['Dyspnoea', 'Fatigue', 'Pyrexia']",1,MODERNA, 924209,TN,48.0,F,"PATIENT DEVELOPED PRURITUS WIHTIN 20 MINUTE POST INJECTION. RECEIVED BENADRYL 50 MG ORAL, AND AFTER PATIENT'S PRURITUS WAS RESOLVED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,NONE,,,,,['Pruritus'],1,MODERNA,IM 924210,VA,46.0,F,3 days after injection (Thursday 12/24/20)noticed pain and pressure from jaw to ears on left side of face. Saturday morning (12/26/20) noticed left lymph node was swollen. Sought medical care-DX anterior cervical lymphadenopathy.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/24/2020,3.0,PVT,unknown,unknown,unknown,,unknown,"['Facial discomfort', 'Facial pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 924211,AZ,42.0,F,"Moderna COVID-19 Vaccine EUA I became lightheaded, dizzy, with weakness in arms and hands, fatigue, sore arm at the injection site about 35-40min after the vaccine was administered. Still feeling lightheaded with weakness 26 hours later.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PUB,"multivitamin, ibuprofen",headache,"psoriatic arthritis, PCOS",,penicillin,"['Dizziness', 'Fatigue', 'Injection site pain', 'Muscular weakness']",1,MODERNA,IM 924212,,51.0,F,"Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/6/2021 � Date: 1/6/2021 � Subjective Patient is a 51 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. � She denied any history of previous adverse reactions to vaccines. � She was given the Pfizer vaccination in the left deltoid muscle. � During her 15 minute waiting period after the injection, the patient began to experience dizziness, flushing and HA. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling. � This provider was notified of patient reaction and she was then assessed in the emergency bay area. � Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting. � Hx: pt has history of breast CA and is on oral chemotherapy. � � ALLERGY REVIEW OF SYSTEMS: All other systems negative � � � Objective � Vitals Vitals: � 01/06/21 1415 01/06/21 1427 01/06/21 1443 BP: (!) 168/89 (!) 154/94 (!) 154/84 Pulse: 87 85 72 SpO2: 99% 98% 99% � Physical Exam Vitals signs and nursing note reviewed. Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Right Ear: External ear normal. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Musculoskeletal: Normal range of motion. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. � � � Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP. � Pt was given Food and water and started to feel better. For her headache she was given Tylenol 1000 mg orally. Pt left clinic at 2:45 pm. � � � Electronically Signed 1/6/2021 2:44 PM � �",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Dizziness', 'Flushing', 'Headache']",2,PFIZER\BIONTECH,IM 924213,NY,29.0,F,"1/4/21 12 hr after vaccine fever of 101.3 bodyache and chills . On 01/05 Joint pain ,chest pain hot sweat chills and diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Arthralgia', 'Chest pain', 'Chills', 'Diarrhoea', 'Feeling hot', 'Hyperhidrosis', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 924214,TX,57.0,F,rash developed under breasts one hour after vaccination. rash continued until the next morning as well as fever symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PHM,could not get back in touch with patient to find out,could not get back in touch with patient to find out,could not get back in touch with patient to find out,,could not get back in touch with patient to find out,"['Pyrexia', 'Rash']",1,MODERNA,IM 924215,,37.0,M,"Within minutes patient experienced light headedness, flushing, reports that he felt like fainting and he felt his heart racing He was taken to ER and only finding was elevated BP. Pt was interviewed an hour after incident and reported that all sx had resolved. Pt was discharged and came by vaccine clinic to report he had recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"losartan crestor, esomeprazole all taken daily and last taken this morning",,HTN high cholesterol,,no known drug allergies no environmental allergies,"['Blood pressure increased', 'Dizziness', 'Flushing', 'Palpitations']",2,PFIZER\BIONTECH,IM 924216,ME,28.0,F,heart racing mild tongue tingling anxious,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,"loratidine, vit D, oral contraceptive, Insulin",patient denies,"type 1 diabetes, seasonal allergies",,NKDA,"['Anxiety', 'Palpitations', 'Paraesthesia oral']",1,MODERNA,IM 924217,,46.0,F,"Patient reports Phlegm, numbness of tongue, fatigue, body aches and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,,,,,,"['Fatigue', 'Headache', 'Hypoaesthesia oral', 'Pain', 'Productive cough']",UNK,MODERNA, 924218,MI,33.0,F,"SOTROAT, JAW PAIN AND EAR PAIN 3 DAYS POST VACCINATION",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/20/2020,3.0,PVT,"SOOLANTRA, PRENATAL",SEASONAL ALLERGYS,,,"ASA, MOTRIN, SALICYLATES","['Ear pain', 'Oropharyngeal pain', 'Pain in jaw']",1,PFIZER\BIONTECH,IM 924219,NY,36.0,F,"Received the Pfizer vaccine at 3:18pm, 20 minutes later reported itchy throat and nose. Reported 3/10 severity of symptoms. Patient reported mild swelling of throat 5 minutes later. When reassessed her symptoms were the same, no signs of angioedema, no coughing. Patient able to talk with no difficulty, denies shortness of breath and chest tightness, patient was able to drink and swallow without much difficulty. Patient continued to complain of symptoms and requested IM Benadryl. Reported her partner would be picking her up and take her home. Vital signs were taken prior to Benadryl administration and were: BP 108/71, HR 69, O2 99% RA at 4:15pm. Benadryl 25mg IM administered to right deltoid at 4:21pm. Vital signs taken after administration were: BP 105/69, HR 72, O2 99% RA at 4:31pm. Declined ED, states she is feeling better. Patient was escorted by RN to partner's car; she was ambulating and declined the wheelchair.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,"Raw onion, garlic, maple syrup","['Nasal pruritus', 'Pharyngeal swelling', 'Throat irritation']",1,PFIZER\BIONTECH,IM 924220,NY,32.0,M,"Patient presented back to office approximately 90 minutes after injection complaining of itchy and wet feeling in back of throat. Patient given Diphenhydramine 25mg IM, per provider order, patient tolerated well. Patient reported symptoms improved but not fully resolved, still had wet feeling in throat. Precautions reviewed, patient demonstrated understanding.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,No known medications,"No illness at the time, prior illness unknown",Unknown,,No known allergies,"['Oropharyngeal discomfort', 'Throat irritation']",1,MODERNA,IM 924221,CA,62.0,F,"within 5 minutes after injection had palpitations, flushing , tachycardia of 124 and BP of 154/106. Skin rash of erythema and mottling, no urticaria, feeling of impending doom, burning in chest. given Benadryl and symptoms resolved after 30-40 minutes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"estradiol patch, progesterone, vit D3",none,"history of breast cancer/chemotherapy 1998/2008- s/p adriamyncin, cytosine, taxol",,sulfa drugs,"['Anxiety', 'Chest pain', 'Flushing', 'Livedo reticularis', 'Palpitations', 'Rash erythematous', 'Tachycardia']",1,MODERNA,IM 924222,NM,23.0,F,Patient reported to have a high fever over night (103 F),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,PHM,,,,,,['Pyrexia'],1,MODERNA,SYR 924223,MO,21.0,F,Rash of chest that was very itchy.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Pruritus', 'Rash']",2,PFIZER\BIONTECH,SYR 924224,,49.0,F,Raised bump at the injection site. Lymp pain and swelling at the same side of the injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/05/2021,6.0,PVT,,,,,,['Injection site swelling'],1,MODERNA,IM 924225,VA,28.0,F,"Severe muscle aches, joint pain, chills, fever up to 102 Fahrenheit, fatigue, dizziness, headache, diarrhea. Started about 5 hours after injection. Was unable to attend work and normal daily activities.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PUB,None,None. I had a positive covid test 11/27/2020,Exercise induced asthma,,None,"['Arthralgia', 'Chills', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Impaired work ability', 'Loss of personal independence in daily activities', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 924226,NE,85.0,F,"WITHIN 7 MINUTES, DEVELOPED LIGHTHEADEDNESS WHILE SITTING AND STANDING, THAT LASTED UNTIL 12PM ON 1/5/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,,,,,,"['Dizziness', 'Dizziness postural']",1,PFIZER\BIONTECH,IM 924227,AR,37.0,F,Sore arm with rash/redness,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/06/2021,9.0,SEN,unknown,unknown,unknown,,unknown,"['Erythema', 'Pain in extremity', 'Rash']",UNK,MODERNA,IM 924228,GA,57.0,F,"100.2 temp, HA and muscle soreness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"atorvastatin, chlorthalidone, diazepam, escitalopram, estraiol, lorvess, lorazepam, proair, synthroid",,,,,"['Body temperature increased', 'Headache', 'Myalgia']",UNK,MODERNA,IM 924229,CA,46.0,F,"Sharp pain in left arm, Dizziness, room spinning, nauseated, Trouble breathing, Heart beating fast.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,,,,,"Penicillin, latex, Sulfas, morphine","['Dizziness', 'Dyspnoea', 'Heart rate increased', 'Nausea', 'Pain in extremity', 'Vertigo']",1,MODERNA, 924231,CA,55.0,F,Queasy No taste headache tight neck- stiff,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Ageusia', 'Headache', 'Muscle tightness', 'Musculoskeletal stiffness', 'Nausea']",1,PFIZER\BIONTECH,SYR 924232,CA,43.0,U,"30min after first shot on December 17th had numbness up my left jaw and migraine headache on both temples. Numbness to jaw lasted 5 days, migraine headache lasted till January 1st. Second shot was on January 5th, 20 minutes after the shot left numbness to the jaw and entire cheek. Persistent sense. Headache worse than the first shot, but not vomiting because prescription phenergan and zofran.. negative covid tests since March",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Imitrix and phenergan and zofran one week prior. Ibuprofen morning if.,"Migraine HA 30min after 1st shot, HA lasted dec 17 til Jan 1st.",None. HA related to menstrual cycle,,None,"['Headache', 'Hypoaesthesia', 'Similar reaction on previous exposure to drug']",2,PFIZER\BIONTECH,IM 924233,NV,44.0,F,"1 hour from the time of administration, my throat began to tighten/narrow and became numb - no loss of airway. Administered self Benadryl for 24 hours following. Symptoms relieved within 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Propanolol,None,Essential Tremors,,Iodine - Shellfish,"['Pharyngeal hypoaesthesia', 'Throat tightness']",1,MODERNA,IM 924234,WA,31.0,F,anaphylaxis,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,,,,,shellfish and dairy,['Anaphylactic reaction'],1,PFIZER\BIONTECH,IM 924235,WA,51.0,F,"Headache, light headed, instant nasal congestion and malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,Atenolol Multiple vitamins,None,Hypertension,,IV contrast Dye,"['Dizziness', 'Headache', 'Malaise', 'Nasal congestion']",1,PFIZER\BIONTECH,IM 924236,AR,37.0,F,sore arm with rash/redness,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/06/2021,9.0,SEN,unknown,unknown,unknown,,unknown,"['Erythema', 'Pain in extremity', 'Rash']",UNK,MODERNA,IM 924237,CA,46.0,F,"Received vaccination on right arm, the next morning felt radiating pain up to the neck and behind the ear. Was temporarily resolved with APAP and Advil",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,Multivitamins,no,Synthroid,,,"['Headache', 'Neck pain', 'Pain']",1,PFIZER\BIONTECH,IM 924238,FL,,F,menthol sensation in throat and chest lasted 15 mins,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/1959,01/06/2021,22647.0,UNK,,,,,,['Feeling cold'],1,MODERNA,IM 924239,,45.0,F,Employee requested the vaccine be given in gluteal muscle and the nurse assigned to the vaccine clinic administered Covid-19 vaccine in the gluteal muscle. Nurse made aware that immunizations are to be given in the deltoid. Employee was notified by the nurse that the gluteal muscle was not studied and that the recommended site is the deltoid and advised that the next injection will be administered in the deltoid.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PVT,,,,,,['Product administered at inappropriate site'],1,MODERNA,IM 924240,KS,33.0,F,5PM on the 31st my injection site was very painful. The next day I was extremely fatigued and had a headache as well.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Prenatal vitamins, Vitamin B6 and Unisom as needed, Omega 3 fatty acid and Vitamin D3, Pepcid AC",No,No,,"No food allergies but allergic to Bactrim, sulfa, penicillin and azithromycin","['Fatigue', 'Headache', 'Injection site pain']",1,MODERNA,SYR 924241,,39.0,F,"experienced throat ""swelling"" and itchy throat 5 minutes after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,UNK,,,,,,"['Pharyngeal swelling', 'Throat irritation']",UNK,PFIZER\BIONTECH, 924243,WI,38.0,F,"Swelling, pain, itching, red, and warm to the touch",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,01/04/2021,8.0,PVT,75mg Sertraline Zinc Vitamin D Vitamin C,None,Pituitary tumor,,Sulfa,"['Erythema', 'Pain', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,IM 924244,FL,53.0,F,"Fever since 5 hours after injection. Chills, body ache, headache Fever as high as 102.6 at morning of the next day and 100.8 24 hours late",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2020,01/05/2021,366.0,PVT,Tylenol 1000 mg,None,No,,Pen VK Amoxicillin Bactrim NSADs Aspirin,"['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 924245,MA,31.0,F,"developed runny nose 24 hrs after receiving first dose of vaccine. Runny nose improved in 3 days. Also had intermittent mild headache for 2 days after first dose of vaccine. Still had nasal congestion 7 days later. Reported adverse side effects to my hospital's employee health on Saturday Jan 2,2021. Employee health had me leave work at noon time on Saturday Jan 2, 2021 to be swabbed for covid.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/28/2020,1.0,PVT,none,none,none,,no known allergies,"['COVID-19', 'Coronavirus test positive', 'Headache', 'Nasal congestion', 'Rhinorrhoea']",1,MODERNA,IM 924246,IL,36.0,F,Developed twitching of Left eye on 12/20/20 which continues to 1/4/21,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/20/2020,1.0,PVT,,,,,"Penicillan, amoxicillin, Azelastine, Erythromycin, prednisone",['Blepharospasm'],1,PFIZER\BIONTECH,IM 924247,CA,38.0,F,"I was 5.5 weeks pregnant when I revived the Pfizer Covid Vaccine. Everything was seemingly going fine with my pregnancy until about 4 hours after receiving the vaccine when I went to the bathroom nd wiped and saw pink discharge on the toilet paper. I then began to have mild low abdominal cramping. The abdominal cramping and vaginal bleeding steadily increased in severity over the next 24 hours until I eventually had an obvious miscarriage the evening of 12/31/2020. I cant help but think the vaccine in some way caused my body to reject the pregnancy. Along with the miscarriage, I also had extreme tiredness with GI upset 12/31/20 - 1/02/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,UNK,Prenatal Vitamin,None,None,,NKA,"['Abdominal discomfort', 'Abdominal pain lower', 'Abortion spontaneous', 'Exposure during pregnancy', 'Fatigue', 'Vaginal haemorrhage']",1,PFIZER\BIONTECH,IM 924248,KS,22.0,F,Patient received 1st dose Moderna vaccine on 12/29/2020. Reports some soreness noted the next day. Reports redness and tenderness developed last evening (1/5/2020) and still present today. Site measured. 4 cm x 3 cm induration noted. Not warm to the touch. Denies fever or other symptoms. Reaction did not develop until 1 week post vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,"Apri, Lexapro, Protonix",None,"GERD, Anxiety",local reaction after influenza vaccine. Resolved within a few days. Flulaval administered 10/02/2020.,"Augmentin, Amoxicillin, Clindamycin","['Erythema', 'Pain', 'Tenderness']",1,MODERNA,IM 924249,AR,38.0,F,sore arm with rash/redness,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/06/2021,9.0,SEN,unknown,unknown,unknown,,unknown,"['Erythema', 'Pain in extremity', 'Rash']",UNK,MODERNA,IM 924250,PA,29.0,F,"Reaction started on 1/5/20. Site is red, hard, itchy, hot to touch, and raised approximately 2-3 cm. Remains afebrile. Seen by Provider via Telemedicine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/05/2021,7.0,WRK,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 924251,AZ,45.0,M,"Patient presenting approx 45 minutes after injection with facial swelling to eyelids and upper face. Also had an associated pruritic rash on right upper back region. No swelling to mouth, lips or tongue. No SOB or wheezing. Symptoms improved (decreased swelling) with 50mg PO benadryl. Was discharged after monitoring for 2 hours. Provided rx for epi pen upon discharge.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"metformin, insulin, lisinopril",,"diabetes mellitus type 2, hypertension, hx of alcohol abuse,",,"Bee sting, watermelon","['Blood glucose abnormal', 'Rash', 'Rash pruritic', 'Swelling face', 'Swelling of eyelid']",1,MODERNA,SYR 924252,NY,56.0,M,"Low grade fever (100.5 F) muscle pain, chills, headache, injection site pain. Medcation :Tylenol. Symptoms went away after 10 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,none,none,none,,none,"['Chills', 'Headache', 'Injection site pain', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 924253,NY,33.0,F,"Palpitations Heart rate 120-130 chest tightness, pulse ox 100 pt was monitored and 15 min later had another episode of palpitations,chest tightness and fast HR",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['Chest discomfort', 'Heart rate increased', 'Palpitations']",1,MODERNA,IM 924254,ME,45.0,F,"Patient II, a 45-year-old female with a history of vaccine-related anxiety, presented to the vaccine clinic for her second-dose of the pfizer COVID-19 vaccine. Pharmacist then delivered vaccine. Almost immediately after administration, the patient started showing signs of distress including difficulty speaking, and going in an out of consciousness. Ice packs were placed on the back of patient's neck, and she was given water in order to hopes to stimulate consciousness. At this time, the pharmacist placed a pulse oximeter on her finger to monitor. Her oxygen stats dropped to 75% and heart rate dropped to a value slightly greater to slightly under 30 beats per minute as indicated by the pulse ox blinking at 30. Pharmacist timed the period of bradycardia, after 60 seconds an epinephrine pen 0.3mg was administered to the left lateral thigh. Rapid response code was called and team came 1.5 - 2 minutes after epinephrine administration. Oxygen was given to the patient at the scene where her recorded blood pressure was 94/54 mmHg. She was then transported into the emergency department via wheelchair. Patient stabilized and was discharged back to work approximately an hour after arrival.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,"mild chronic anemia, hyperuricemia",,,"['Aphasia', 'Bradycardia', 'Consciousness fluctuating', 'Emotional distress', 'Heart rate decreased', 'Immediate post-injection reaction', 'Oxygen saturation decreased']",2,PFIZER\BIONTECH,IM 924255,,55.0,F,5 minutes after receiving Covid-19 vaccination patient reacted with chest tightness and was very lightheaded. Patient has a history of anaphylaxis and had Epi Pens with her. 1600 Vitals: BP: 184/72 P: 117 SaO2: 100% Epi Pen self-administered. 1605 Vitals: BP: 125/74 P:103 SaO2: 100% Nurse transferred patient to ER in wheelchair for further treatment and evaluation.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,Anaphylaxis to Chocolate,"['Chest discomfort', 'Dizziness']",1,PFIZER\BIONTECH,IM 924256,CA,52.0,F,"High fever; headache; myalgia ; inbility to smell or taste; fatigue on 22nd; hAD THOSE SYMPTOMS FOR ABOUT A WEEK; tested positive for COVID on Dec 26. haven't recovered inablity to smell or taste; fatigue - still have that, too;",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,none,none,none,,none,"['Ageusia', 'Anosmia', 'COVID-19', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 924257,TN,60.0,F,"PATIENT DEVELOPED ITCHINESS AND WARM FLUSH ALL OVER BODY WIHTIN 20 MIUTE POST INJECTION, AND RECEIVED 50 MG BENADRYL ORAL AND 20 MG FAMOTIDINE ORAL, AND AFTER 30 MINUTES, ADVERSE REACTION HAS BEEN RESOLVED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,PRE MEDICATED WITH BENADRYL 50 MG ORAL,,,,,"['Flushing', 'Pruritus']",1,MODERNA,IM 924258,CA,40.0,F,"overwhelmingly tired exhausted sever fatigue left arm hurts extremely bad by shoulder severe dryness in mouth, almost hard to swallow severe nausea headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,UNK,,,,,,"['Dry mouth', 'Dysphagia', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pain in extremity']",1,MODERNA,SYR 924259,MN,44.0,F,"pt noted feeling chills, then developed nausea and dry heaves and sl headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,,,,,"lisinopril, mobic","['Blood glucose normal', 'Chills', 'Headache', 'Nausea', 'Retching']",2,PFIZER\BIONTECH,IM 924260,CA,36.0,F,Facial hives: resolved with PO Benadryl Right eye/cheek muscle twitching (ongoing for 1 week and continuously occurring).,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,"Tapazole, Vitamin D",Grave?s Disease,,,Avocado,"['Blepharospasm', 'Muscle twitching', 'Urticaria']",UNK,PFIZER\BIONTECH, 924261,UT,21.0,F,"*I am a nursing student who received the vaccine because I am in a nursing program. Employee at Public Health Dept agreed I should file this report and file it myself because I have the most accurate description of the symptoms that occurred What happened after vaccine administration within about ~10 minutes (01/04/2021) -what felt like a bit of throat tightening/swelling that would come in spurts and go away -difficulty taking a deep breath, could still breathe adequately normally -took more effort to breathe deeply/have a normal baseline breathing pattern -faster heart rate than normal, could feel it ?racing? a bit- was about 82 (radial, took it myself) *thought these were attributed to my anxiety of sitting in a crowded room not close to the exit (I have bad anxiety with being in new locations and not being in control of where I can place myself around others (I do not have an anxiety disorder but experience anxiety of this kind semiregularly) *sat a few extra minutes (about 20 minutes) and then left the observation area confident I was overthinking and I was just me being anxious/not the vaccine After walking out/leaving -spurt of dizziness/nausea -chills -hot forehead -spurts of widespread headache -effort to take in deep breaths -not as noticeable racing heart rate -spurts of throat tightening/swelling (not severe) Back home Same things as leaving -spurt of dizziness/nausea -chills -hot forehead -spurts of widespread headache -effort to take in deep breaths -not as noticeable heart rate -spurts of throat tightening/swelling (not severe) -spurts of throat tightening went away in about an hour After 1-3 hours -heart rate and breathing still making me uncomfortable but did not feel like an emergency -could feel heart rate when laying down/felt racing to me again when lying down, not very much when sitting up Breathing remained uncomfortable for the rest of the day/effortful into the evening -heart rate felt normal in the afternoon/evening -talking on the phone took more effort than usual but was not too difficult Later that night I was able to lay down without a racing feeling heart rate, breathing was better, and slept fine. The next morning I woke up (01/05/2021) without any effortful breathing or racing heart rate and without any other abnormal symptoms; symptoms I did experience were arm soreness and some fatigue Today 01/06/2021 my arm soreness is very mild and I am not experiencing any other symptoms -did not download the v safe app until 01/05/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,oral contraceptive lactaid pills,monthly menstruation periodic anxiety,torn labrum in right hip (similar s/s in left hip) seasonal allergies,,"sensitivity to latex (Band-Aids, gloves do not cause issues) sensitivity to melons (cantaloupe) watermelon, pineapple, grapes, avocado (can eat in small amounts)","['Anxiety', 'Chills', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Feeling hot', 'Headache', 'Heart rate increased', 'Nausea', 'Pain in extremity', 'Palpitations', 'Pharyngeal swelling', 'Throat tightness']",1,MODERNA,IM 924262,IA,36.0,F,"redness, swelling, hives at the injection site several days after the vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/02/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site swelling', 'Injection site urticaria']",1,MODERNA,IM 924264,CA,,F,"Patient received the covid vaccine on 01/05/2021. c/o new onset fever of 101.2, fatigue, headache, and body ache. Denies cough, sore throat, any ocular or GI symptoms. Covid test on 12/3/2020 was positive.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,UNK,,,,,,"['COVID-19', 'Fatigue', 'Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 924265,OH,31.0,F,"localized pain, swelling, and induration that has persisted >24 hours after injection; intermittent head and neck pain most prominent on the same side as the injection for >24 hours after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"metformin 500mg, Nora-be, prenatal vitamin w/DHA",none,type 2 diabetes,,NKDA,"['Headache', 'Induration', 'Neck pain', 'Pain', 'Swelling']",1,MODERNA,IM 924266,MI,27.0,F,"WEAKNESS, HEAVY FEELING , FEELING LIKE GOING TO PASS OUT, CHEST HEAVINESS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,NO,NO,NO,,NO,"['Asthenia', 'Chest discomfort', 'Discomfort', 'Dizziness']",1,PFIZER\BIONTECH, 924267,IL,36.0,F,Pt developed Left eye twitching on 12/20/20 which continues to 1/4/21,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/20/2020,1.0,PVT,,,,,"Penicillin, erythromycin, acetominiphen",['Muscle twitching'],1,PFIZER\BIONTECH,IM 924269,OH,22.0,F,"Three days after receiving the vaccine, the swelling, redness, and itching was gone. By day number nine, i woke up with my left bicep (where the vaccine was injected) swollen, red, and itchy again. Even worse than when i originally got the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,WRK,Florajen,,IBS-D Raynauds Phenomenon Upper hiatal hernia,Chicken pox booster,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 924270,CA,33.0,F,Left arm pain and headaches and tiredness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/24/2020,8.0,WRK,Advil Nasal Spray,No,No,,Flagyl,"['Headache', 'Pain in extremity', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH,IM 924271,MN,35.0,F,"Vaccine site was itchy, swollen and red 1 week after vaccine was given. I felt warm on the side of the body vaccine was given. I took a Benedryl. On day of vaccine I was tender to the touch with swollen and redness. But that only lasted up to 2 days. I felt no issues between this day and the the day 1 week after.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,SEN,Just tylenol or advil for typical pain. I don't believe I took any the day of the vaccine.,none,none,,Levofloxin,"['Erythema', 'Feeling hot', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Pain of skin', 'Swelling']",UNK,MODERNA, 924272,NY,89.0,F,Patient had got the covid vaccine that very day she had swollen eyes she continues to have itchy swollen eyes and is starting on prednisone.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,SEN,Bisporolol 5 mg Refresh Classic P/F Aspercreme Lidocaine 4% patch Lorazepam 0.5 mg Bepreve Eye drops 1.5% Potassium CL 20 mEq Hydrocodone/APAP 5/325 Magnesium Oxide 400 mg Vitamin D 3 50000 unit Simvastatin 10 mg Citalopram 20 mg Metformin,,"Hypertension, Edema, Hypokalemia, Type II DM, CAD, Pain, Vitamin D Def, Mag Def.",,Sulfa Antibiotics,"['Eye pruritus', 'Eye swelling']",1,PFIZER\BIONTECH,IM 924273,TX,43.0,F,"chills, muslce aches, joint pain/stiffness, headache - all extreme; I did have COVID-19 about 7 weeks ago",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,aspirin,none,none,,sulfa,"['Arthralgia', 'Chills', 'Headache', 'Joint stiffness', 'Myalgia']",UNK,MODERNA,SYR 924274,,60.0,F,"Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/6/2021 � Date: 1/6/2021 MRN: 3274958 � Subjective Patient is a 60 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. � She denied any history of previous adverse reactions to vaccines. � She was given the Pfizer vaccination in the right deltoid muscle. � During her 15 minute waiting period after the injection, the patient began to experience dizziness and flushing. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. � This provider was notified of patient reaction and she was then assessed in the emergency bay area. � Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting. � Pt reports she saw an allergist this am for runny nose, SOB, and sneezing. He determined her symptoms was a neurological response. Previous COVID infection November 30, 2020 � PREVIOUS REACTION: Pt reports first Pfzier covid shot she had symptoms of Chills, HA, nausea and fever of 102 that occurred 12 hours afterwards. She states her symptoms lasted 6-8 hours. � � ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness � � � Objective � Vitals Vitals: � 01/06/21 1235 BP: (!) 152/82 Pulse: 57 Temp: 99.2 �F (37.3 �C) SpO2: 100% BS 94 at 12:38 � Physical Exam Vitals signs and nursing note reviewed. HENT: Head: Normocephalic. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are dry. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. � � � Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP. � � Pt was observed and given water and food (peanut butter). Felt better within a few minutes. She was released to go home 12:55pm � � APRN Electronically Signed 1/6/2021 12:45 PM � �",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Body temperature increased', 'Dizziness', 'Dyspnoea', 'Flushing', 'Neurological symptom', 'Rhinorrhoea', 'Sneezing']",2,PFIZER\BIONTECH,IM 924275,NY,28.0,F,"Temp 102.6 while taking tylenol, headache muscle, Hr 140 01/05/21 chills, lightheadedness, 01/06 diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Body temperature increased', 'Chills', 'Diarrhoea', 'Dizziness', 'Headache', 'Muscle disorder']",1,PFIZER\BIONTECH,IM 924276,MA,31.0,F,"developed runny nose 24 hrs after first dose of vaccine. Runny nose improved by Thursday December 31, 2020. Still had nasal congestion one week later. Saturday Jan 2, 2021 reported symptoms to employee health at hospital. Employee health had me leave work at noon time on Saturday Jan 2, 2021 to be tested for corona virus.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/28/2020,1.0,PVT,none,none,no,,none,"['COVID-19', 'Nasal congestion', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,MODERNA,IM 924278,FL,40.0,F,"Fever up to 102.6 on Tylenol Chills to sweats, mostly extreme chills Every muscle in my body ached, could not lay or sit without pain Extreme fatigue, hard to even hold a cell phone Piercing headache Running nose from crying Could not watch tv, lay, get comfortable, get up to eat. Drank lots of water and peed alot",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,no,Covid-19 11/29/2020 to 12/12/2020,none,,nka,"['Chills', 'Crying', 'Fatigue', 'Grip strength decreased', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Pyrexia', 'Rhinorrhoea']",1,MODERNA,IM 924279,IL,29.0,F,Swollen lymphnodes in left armpit/underarm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,PVT,Nuvaring and Zyrtec,,,,,['Lymphadenopathy'],1,MODERNA,SYR 924280,NY,23.0,F,"Muscle aches (day after vaccination 12/29/2020), sore arm (start 12/29/2020), injection site redness, itching, warmth & swelling (start 12/29/2020), injection site redness and swelling tripled in original size (as of 1/6/2021, still current), nausea (start 1/4/2021, still current), GI upset (start 1/4/2020, still current)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,"Metformin (1000mg/day), bupropion (300mg/day), phentermine(37.5mg/day), prenatal vitamin 1x/day, vitamin C (25mcg/day), hair/skin/nail vitamin 1x/day, women?s once a day multivitamin 1x/day",None,"Pseudo tumor cerebri, iron deficiency, microcytosis",,None,"['Abdominal discomfort', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Myalgia', 'Nausea', 'Pain in extremity']",1,MODERNA,IM 924281,IL,36.0,F,Pt developed a twitching Left eye on 12/20/20 which continues on 1/4/21,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/20/2020,1.0,PVT,,,,,,['Blepharospasm'],1,PFIZER\BIONTECH,IM 924282,NJ,66.0,F,"Patient reported feeling tingling sensation in mouth and mouth ""feeling swollen"". approx 228 No observed swelling or difficulty with breathing. Also reported flushed feeling BP 140/82. Reported Had hx of allergic reaction to lisinipril in past 4 years ago and was hospitalized and was in ICU. Afebrile. Also reported having an unpleasant bad taste in mouth. Bendadryl 25mg po given 228 pm. reported feeling a little better within 15 minutes. Water given. Approx 3:00 pm reported having another episode of flushed feeling and just not feeling right. Denied the need for epi-pen. Reported normally takes 50mg of bendaryl. Additional dose of bendadryl 25mg oral given 3:05. Requested client to contact family member fort transportation. Spoke with Daughter. Clients sister came to clinic that was held at college. Client remained alert and oriented. Contacted case's primary care provider's office, provider Doctor not available, but covering provider will return call to her. Reported she could not be seen in office today. Requested refill for epipen to be provided to case by doctor. Case denied the need for epipen at center and any further medical care or call to 9ll for emergency care. Case was advised to be monitored throughout with another family member. Lives alone, will be staying with daughter or sister. Verbalized to call 911 if any difficulty with breathing or worsening of symptoms. Dr.'s office reported they would follow up with client today after patients are seen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,none,,Hypertension,,Lisinipril,"['Hot flush', 'Intensive care', 'Mouth swelling', 'Paraesthesia oral', 'Taste disorder']",1,MODERNA,IM 924283,NV,38.0,M,"Severe headache (""worst headache of my life""), tremor, weakness, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,PVT,"clomid, testosterone",Patient did donate blood the morning of vaccination just prior to vaccination,Low Testosterone,,Ceclor,"['Asthenia', 'Computerised tomogram head', 'Fatigue', 'Full blood count', 'Headache', 'Metabolic function test', 'Tremor']",UNK,PFIZER\BIONTECH, 924284,MA,61.0,F,"Within 5 minutes felt warm sensation over body, felt lump in throat , then chest tightness with palpitations.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Pravastin Vitamin D Valtrex Tylenol Ibuprofen Probiotic,None,Hyperlipidemia Herpes Spinal stenosis,,Environmental allergies only,"['Chest discomfort', 'Feeling hot', 'Palpitations', 'Sensation of foreign body']",UNK,MODERNA,SYR 924287,,49.0,F,purulent cellulitis to left deltoid; 10cm diameter and circular,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/02/2021,4.0,UNK,,,,,,['Injection site cellulitis'],1,MODERNA,IM 924288,NY,48.0,F,"Reported pain at injection site fever 101.8F, chills,diarrhea, chest tightness, shortness of breath. Took tylenol-symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,PVT,,,,,,"['Chest discomfort', 'Chills', 'Diarrhoea', 'Dyspnoea', 'Injection site pain', 'Pyrexia']",1,MODERNA,IM 924289,IL,50.0,M,"Tiredness, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Flomax 0.4 mg QD Celexa 20 mg QD Protonix 40 mg QD Zolpidem 10 mg PRN HS ASA81mgQD Ramipril 2.5 mg QD Zocor 40 mg HS Plavix 75 mg QD Coreg 25 mg BID multivitamin Glucosamine,None,Coronary artery disease Chronic hypertension Barrett?s esophagus,,Lidocaine,"['Chills', 'Fatigue']",1,PFIZER\BIONTECH,SYR 924290,,46.0,F,"Feels throat tightness, feels liek her throat has mucous and she has to clear her throat. Client is able to sip water with no difficulty. Client able to ambulate. BP 136/82; HR 102; RR 18. at time of onset. Denies lightheadedness or chest tightness. No stridor per auscultation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,NONE,none,migraines,,"Shellfish, penicillin, almonds","['Sensation of foreign body', 'Throat clearing', 'Throat tightness']",1,MODERNA,IM 924291,OK,64.0,F,"I got the vaccine at 9am. At 4pm that same day I experienced terrible pain to left arm. No redness or swelling at the site. I couldnt lie on my left arm at all that night. By 11pm I also experienced headache, sinus drainage, sore throat, body aches, taste and smell were off, upset stomach, queezy stomach but no nausea or vomiting, very weak , dry mouth, fever at 99.2 then 98.6, chills, lots of chills. The covid hotline at my work told me I had a moderate reaction to the vaccine. Treatment was rest and tylenol which didn't alleviate any symptoms whatsoever. I had all these symptoms til Jan 6th at 4am. At 4am all the symptoms left and have not returned.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,"Lipitor, Pristiq, Buspar, Cholestid, acyclovir",I had symptoms of covid about 4 weeks prior to vaccine,depression and anxiety,,none,"['Abdominal discomfort', 'Asthenia', 'Chills', 'Dry mouth', 'Headache', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Parosmia', 'Pyrexia', 'Sinus disorder', 'Sleep disorder', 'Taste disorder']",1,PFIZER\BIONTECH,IM 924292,MT,31.0,F,"Pain in armpit/lymph node, itching at injection site x 2 days, Redness/hot to the touch/painful since this AM.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,PVT,"Oral birth control, omeprazole",Cold,,,PCN,"['Axillary pain', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Lymph node pain']",1,MODERNA,SYR 924293,NE,76.0,M,DEVELOPED RASH ON NECK AND SHOULDERS. RECEIVED 25MG DIPHENHYDRAMINE BY MOUTH AT 10:15AM. RASH RESOLVED BY 10:30AM,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,,['Rash'],1,PFIZER\BIONTECH,IM 924294,OR,57.0,F,"About 10-15mins after injection pt c/o 'feeling off', she went on to describe feeling a cold sensation go throughout her body and then felt her heart racing, denied SOB, but did state that her tongue might feel thick but then that it went away quickly, pt was very anxious at the time. HR briefly went up to 90's but returned to her normal 70's, BP 130/80 and 120/75. All vitals remained stable. After about 45 mins pt stated she felt ready to go home, after walking with her and monitoring pulse and O2 sats, which were normal. As pt was putting her coat on she had another wave of coldness go through her and heart rate went back up. Pt sat down and pt started clearing throat and slight cough. Pt was taken to the Emergency Department for treatment at that time. Pt given Benadryl and some Solumedrol and discharged with Rx for prednisone. On 1/4/2020 pt completed course of prednisone and on 1/5/2020 pt's symptoms returned and pt saw her PCP for treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,unknown,none,none,,no known allergies,"['Anxiety', 'Cough', 'Feeling abnormal', 'Feeling cold', 'Heart rate increased', 'Palpitations', 'Throat clearing', 'Tongue disorder']",1,MODERNA,IM 924295,MI,33.0,F,DIZZINESS,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/19/2020,0.0,PVT,PEPCID,NO,NO,,NO,['Dizziness'],1,PFIZER\BIONTECH,IM 924297,NY,71.0,M,"At around 11:40am resident was observed to be unresponsive. resident noted with pulse and respiration. Not in any distress. lung sounds clear. Vital Signs BP162/82 P86 R18 T97.1 O2 Sat 96%, fingerstick is 133mg/dl .Resident received COVID 19 vaccine at 11:25am. O2 via 2l NC initiated. Nurse Stat call, 911 initiated, MD at Bedside. Resident awake and responsive. EMT responded and resident left with EMT to be transferred to hospital, remains awake and not in any respiratory distress.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/05/2021,01/05/2021,0.0,SEN,Tylenol Tablet 325 MG (Acetaminophen) Aspirin EC Tablet Delayed Release 81 MG (Aspirin) Topamax Tablet 100 MG (Topiramate) Keppra Tablet 750 MG (LevETIRAcetam) Melatonin Tablet 10 MG Multi-Day Plus Iron Tablet (Multiple Vitamins-Iron) Refre,RIGHT LEG POSITIVE (+) EXAM FOR DVT,"CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED OTHER GENDER IDENTITY DISORDERS MORBID (SEVERE) OBESITY DUE TO EXCESS CALORIES OTHER SEIZURES INSOMNIA DUE TO OTHER MENTAL DISORDER ESSENTIAL (PRIMARY) HYPERTENSION UNSPECIFIED ATRIAL FIBRILLATION ATHSCL HEART DISEASE OF NATIVE CORONARY ARTERY W/O ANG PCTRS SCHIZOPHRENIA, UNSPECIFIED BENIGN PROSTATIC HYPERPLASIA WITHOUT LOWER URINRY TRACT SYMP TYPE 2 DIABETES MELLITUS WITHOUT COMPLICATIONS",,No known allergies.,"['Blood glucose normal', 'COVID-19', 'Unresponsive to stimuli', 'Urinary tract infection']",1,PFIZER\BIONTECH,IM 924298,WV,60.0,F,Sore arm lasting 24-48 hours. Ibuprofen,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Synthroid; Zoloft; LoEstrin;,none,hypothyroid depression,sore arm,None,['Pain in extremity'],1,PFIZER\BIONTECH,IM 924299,CT,57.0,F,"Cough, low grade fever , 24 hours after shot. Positive Covid test on 3rd day after shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/03/2021,1.0,PVT,Vitamin D,None,Mild asthma,,Sal.eterol,"['COVID-19', 'Cough', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,MODERNA, 924300,WI,34.0,F,"Generalized body itch with feeling of swollen tongue, no SOB",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Zyretec,None,Irregular menstrual cycle Viral warts Acne vulgaris History of shingles LGSIL on Pap smear of cervix CIN III (cervical intraepithelial neoplasia III),,AmoxicillinHives Biaxin [Clarithromycin]Itching Cefdinir Sulfa (Sulfonamide Antibiotics)Hives Bactrim [Sulfamethoxazole-trimethoprim]Rash ClindamycinRash,"['Pruritus', 'Swollen tongue']",1,MODERNA,IM 924301,OR,60.0,F,"Pain in the arm a t the injection site, now having shoulder pain. woke up with headache and dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,multivitamins,no,Leaky Heart valve,,"Arithromycin, Iron","['Arthralgia', 'Dizziness', 'Headache', 'Injection site pain']",1,MODERNA,IM 924303,OK,76.0,F,Devoped a fever of 99.0 approximately 24 hours after the injection. Took a 600 mg Tylenol at my home.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PUB,Metapoporal 25 mg,No,No,,None known,['Pyrexia'],UNK,MODERNA,SYR 924304,CA,40.0,F,Severe headache severe nausea fatigue left arm pain severe dry mouth high pulse,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,,,UNK,,,,,,"['Dry mouth', 'Fatigue', 'Headache', 'Heart rate increased', 'Nausea', 'Pain in extremity']",1,MODERNA,SYR 924305,AL,57.0,F,"Modern a COVID-19 vaccine EUA. One week after receiving the vaccine, the injection site began itching, was hot to the touch, and a lump under the skin could be felt. A dime size red area was at the injection site. The next day, the injection site was still hot, still has a lump, and the redness is now quarter sized. Prior to this, the arm was a little sore for the first one or two days, with no other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,PVT,"Lisinopril, metoprolol, Premarin, levothyroxine, Wellbutrin",None,"Hypothyroidism, hypertension",,None,"['Injection site erythema', 'Injection site mass', 'Injection site pruritus', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 924306,KS,35.0,F,"I received the moderna covid vaccine at approx 0930 and waited in waiting room of facility per policy after injection. I felt ok once wait time was up so I left. I was driving approx 15 min later and (which was approx 30) after administration and pulled over to side of road due to getting chills and shaking and feeling faint. Also, the left side of my face went numb and tingling. I called for an ambulance and once they arrived I had started feeling normal again. Facial tingling still persists at this time hours later. I also had another sync opal episode once I got a ride home that resolved. Left side of face feels like after being numb from a dentist.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,Levothyroxine vit d progesterone estriadol,No,Hypothyroidism endometriosis Rynauds disease,,No,"['Chills', 'Dizziness', 'Hypoaesthesia', 'Impaired driving ability', 'Paraesthesia', 'Syncope', 'Tremor']",7+,MODERNA,IM 924307,CA,44.0,M,"Patient received 2nd dose of Pfizer COVID-19 vaccine at our COVID-19 vaccination area. During the 15 minute observation period, patient reported feeling his tongue swelling and eye getting puffy. No SOB notes. Patient is an ICU physician in our med center. After 30 minutes of observation, he was discharged without any other issues. Follow-up call done after 2 hours and he was fine. He went back to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2020,01/06/2021,366.0,PVT,None,None,None stated,,Cephalosporins,"['Intensive care', 'Periorbital swelling', 'Swollen tongue']",2,PFIZER\BIONTECH,IM 924308,ME,20.0,F,"lightheadedness, shakiness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,no,no,no,,none,"['Dizziness', 'Tremor']",1,MODERNA,IM 924309,NH,26.0,F,Tachycardia and mild hypertension. No specific treatment.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,UNK,"omeprazole, methylphenidate, albuterol inhaler",,"GERD, ADHD",,Penicillin,"['Electrocardiogram', 'Hypertension', 'Tachycardia']",UNK,MODERNA, 924310,NE,56.0,M,BURNING AND REDNESS AT INJECTION SITE. LASTED 2 HOURS. RECEIVED 25MG DIPHENHYDRAMINE AT 12PM. RESOLVED IN 2 HOURS.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,,"['Injection site erythema', 'Injection site pain']",1,PFIZER\BIONTECH,IM 924311,OK,57.0,F,"Fever, muscle aches, body aches, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Lexapro, Vit D",none,none,,none,"['Headache', 'Myalgia', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 924312,NV,34.0,F,"Allergic reaction, shortness of breath, dizziness, itchiness Iv steroids and Benadryl and follow up with pcp",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,None,None,None,,Bees (I carry an epi pen),"['Dizziness', 'Dyspnoea', 'Hypersensitivity', 'Pruritus']",UNK,PFIZER\BIONTECH,SYR 924314,CO,39.0,M,"C/o nausea, numbness, tingling down Left arm, weak, dizzy. Pt was transferred to Emergency Department for further care and observation. Vital signs 140/90, HR 74, SpO2 100%.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,MIL,,,,,PCN,"['Asthenia', 'Dizziness', 'Hypoaesthesia', 'Nausea', 'Paraesthesia']",UNK,MODERNA,IM 924315,,35.0,F,"Progress Notes PA-C (Physician Assistant) ? ? Physician Assistant Cosign Needed Expand All Collapse COVID VACCINE CLINIC 1/6/2021 � Date: 1/6/2021 � Subjective Patient is a 35 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. � She denied any history of previous adverse reactions to vaccines. � She was given the Pfizer vaccination in the right deltoid muscle. � During her 15 minute waiting period after the injection, the patient began to experience dizziness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. � This provider was notified of patient reaction and she was then assessed in the emergency bay area. � Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea and increased work of breathing, skin changes, tongue swelling and vomiting. � � � � ALLERGY REVIEW OF SYSTEMS: All other systems negative Patient complains of dizziness � � � Objective � Vitals Vitals: � 01/06/21 1216 01/06/21 1229 BP: 124/81 117/81 Pulse: 76 69 SpO2: 99% 100% BS not done; no diabetes or history of hypoglycemia. NO allergies. � Physical Exam Vitals signs reviewed. Constitutional: Appearance: Normal appearance. She is normal weight. HENT: Head: Normocephalic. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Palpations: Abdomen is soft. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert. � � Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP. � Patient rested on gurney with head elevated for approximately 15 minutes with symptoms resolving without intervention other than water. � � � PA-C Electronically Signed 1/6/2021 12:29 PM",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,['Dizziness'],2,PFIZER\BIONTECH,IM 924316,,36.0,F,Moderna COVID-19 Vaccine EUA Very sore arm Upset Stomach the following morning,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,UNK,,,,,,"['Abdominal discomfort', 'Pain in extremity']",UNK,MODERNA, 924317,PA,25.0,F,"Pain in arm, headache, sore throat x 2 days. Swelling at site, redness at site, hot to touch, and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,WRK,"Valcyclovir, Nuvaring",,,,,"['Headache', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Oropharyngeal pain', 'Pain in extremity']",1,MODERNA,IM 924318,PA,49.0,F,"Chills,joint pain,muscle aches,nauseated, headache, sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,SEN,None,None,Osteoarthritis,,None,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Nausea', 'Pain in extremity']",UNK,PFIZER\BIONTECH,SYR 924319,NV,25.0,F,"Fast heart rate, nausea, vomiting, muscle aches, low grade fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PUB,Methocarbamol muscle relaxant Align probiotic Citrucel Calcium supplement Magnesium supplement Vitamin D3 supplement Prenatal,,,,,"['Heart rate increased', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,SYR 924320,CA,55.0,M,"""EE reviewed contraindications and verbalized """"non"""" to all contraindications. Vaccine administrd at 1045. 1100 EE stated """"I feel weid"""". EE complained of SOB and dizziness. RN and LVN assisted EE to floor and elevated lower extremities. EE was taking deep breaths, pulse normal. RN, Called ED to notify them of EE situation. 1110 EE breathing normal and EE verbalized, """" no feeling of dizziness"""" and was assisted to sit in chair. 1113 RN escorted EE wo security golf cart and was transported to ED by Manager of security. EE was stable. ED Note 55-year-old male presenting with dizziness and anxiety after vaccination. This is a potentially seriously ill patient with significant medical complexity and risk who was assessed emergently on arrival given their concerning story. Differential includes but is not limited to orthostatic hypotension, cardiac dysrhythmia, atypical presentation of myocardial infarction, allergic reaction, adverse effect of medication. Fortunately, the patient denies any chest pain his troponin is not elevated with no ischemic findings on his EKG. He is nonfocal neurologically make me doubt stroke. He has no findings at this time to suggest an anaphylactic reaction and his vital signs are within normal limits. Orthostats were checked and negative. He has no anemia, leukocytosis or emergent electrolyte derangements that could be participating in his symptoms. Patient is tolerating oral intake and asymptomatic at this time. He was monitored and on serial reassessment developed no no recurrence of symptoms. He is safe for discharge at this time but ED read precautions were given and the patient was discharged from the emergency department in good condition. Impression: Acute dizziness anxiety, suspect adverse medication reaction""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,Osteo Bi Flex,None,None,,None,"['Anxiety', 'Dizziness', 'Dyspnoea', 'Electrocardiogram normal', 'Feeling abnormal']",1,PFIZER\BIONTECH,IM 924322,PA,61.0,M,"Presyncope, temporary dizziness and vertiginous sensation lasting 5 seconds.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Chest X-ray normal', 'Computerised tomogram head normal', 'Dizziness', 'Metabolic function test normal', 'Presyncope', 'Troponin normal', 'Vertigo']",1,MODERNA,IM 924323,MA,60.0,F,"Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscle aches, headache, and nausea about 2am, fever 99.8 at 1pm on 1/6/21. All these symptoms still persist now 5:40pm 1/6/20",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Vit D 50,000u 1x every 2 wks. LD 1/3/2021 Atenolol 25mg 1x every day. LD 1/4/2021 pm",None,PSVT treated with Atenolol Vit D deficiency treated with Vitamin D,,None,"['Dizziness', 'Fatigue', 'Feeling abnormal', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH,IM 924324,MI,44.0,M,"PRESYNCOPE, RIGHT SIDED FACAIL NUMBNESS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,XELJANZ,NO,ARTHOPATHY ANKYLOSING SPONDYLITIS,,"SULFA, AMOX","['Computerised tomogram head', 'Hypoaesthesia', 'Magnetic resonance imaging', 'Presyncope']",1,PFIZER\BIONTECH,IM 924325,UT,20.0,F,"CLIENT STATED SHE WAITED THE 15 MINUTES AND THEN STARTED TO HAVE DIFFICULTY BREATHING AND DROVE AROUND TO ENTRANCE OF CLINIC. CLIENT PRESENTED WITH RAPID, SHALLOW BREATHING, SHAKING. NURSE RAN TO GET EPINEPHRINE WHILE ANOTHER STAFF MEMBER STAYED WITH CLIENT. EMT SUMMONED. EMT GAVE OXYGEN, BENADRYL & CONTINUED TO SPEAK WITH CLIENT'S MOM VIA SPEAKER PHONE AND TO REASSURE CLIENT. FAMILY MEMBER CAME TO PICK UP CLIENT FROM CLIENT.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,"MOSTLY UNKNOWN. PT STATED SHE HAD TAKEN ""INHALER"" WHEN SYMPTOMS FIRST STARTED.",UNKNOWN.,PTSD; BIPOLAR DEPRESSION; ANXIETY; ASTHMA--ACCORDING TO MOM WHO WAS ON SPEAKER PHONE.,,DEMEROL,"['Dyspnoea', 'Hypopnoea', 'Tremor']",1,PFIZER\BIONTECH,IM 924326,ND,59.0,F,"I received the injection at 3:10 pm on 1/5. In the middle of the night, I didn?t check the time, I had severe rigors that lasted what felt like an hour maybe more. I did not have any other rigors since that episode.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,None,None,None,,None,['Chills'],2,PFIZER\BIONTECH,IM 924327,WA,34.0,F,"The day after the vaccination, woke up at 0600 and noted numbness and tingling down right lower extremity from thigh down to toes. Leg was completely ?asleep? and unable to bear weight. Lasted for approximately one hour. Tingling in extremity lasted throughout day and continued for about 1 week. Also noted minor tingling in left toes and right side of face.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/20/2020,1.0,PVT,"Vitamin D, multi vitamin, sunflower lecthicin supplement, Legiondairy milk brand ?Liquid Gold? lactation supplement","?Common cold? 1 week prior to vaccination, Covid-19 negative",None,,"Flagyl, seasonal allergies","['Blood test', 'Hypoaesthesia', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging spinal', 'Paraesthesia', 'Physical examination', 'Weight bearing difficulty']",1,PFIZER\BIONTECH,IM 924328,MD,48.0,F,"c/o headache 5 min after vaccine given initially 4-5/10 then decreased to 3-4/10. vital signs stable 138/91 HR105 no rash, no redness, no induration at site. no resp distress. vital signs recheck 134/91 pulse 97 at 1233, advised to go to ER if symptoms worsened, discharged at 1638. Patient called clinic at 1330 on 1/6/21 c/o continued headache, now improving, Temp 99.2, facial flushing, bilateral arm and leg swelling also now improving. patient advised to go to urgent care or ER however patient refused and said she will go to her new primary MD on 1/8/21 and will go to ER if symptoms worsen. Also patient stated had COVID-19 test by occupational health results pending.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,WRK,"tinidazole, cynocolbalamin, doxycycline, fluctisone nasal, estradiole patch,levothyyroxine,epinephrine pen, azelaic acid topical",unknown,unknown,,"codeine, sulfa, beef, corn, fish, green peas, Milk products, mushrooms oranges, shellfish shrimp, soy, tomatoes","['Body temperature increased', 'Flushing', 'Headache', 'Peripheral swelling', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,IM 924329,PA,75.0,F,Patient reported tingling in her right fingers but reported to Heather that she was fine as of 3:06pm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,unknown,unknown,unknown,,unknown,['Paraesthesia'],1,PFIZER\BIONTECH,IM 924330,PA,26.0,F,"12/31/20: Sore/Tender at site with some redness 1/3/2021: Redness at site with some itchiness 1/5/2021: Redness, swelling, warm to touch, and very itchy at site",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/03/2021,4.0,WRK,,,,FluShots- Soreness and tender at site,,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 924331,IA,60.0,F,"On day 1 after the vaccine the employee began having muscle aches and sore joints. By day 4 she felt like she had an improvement in symptoms. On day 6 the same symptoms reappeared and the employee was tested for COVID (negative PCR). She reports that all of her joints in bilateral upper and lower extremities are extremely sore, she noted that ""even her toes were painful"". She is unable to take NSAIDS because of a history of anaphylactic reaction to Motrin in the past.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,WRK,,,,,,"['Arthralgia', 'Myalgia', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 924332,MI,61.0,F,"pt was mistakenly given an undiluted vial of vaccine. No immediate physical reaction noted. Pt informed of error. Dr., medical director, contacted and informed. OK to monitor pt for a total of 30 min to watch for adverse reaction. If feeling well, may go home after. Recommended at this point to receive 2nd dose. After 45 min from receiving dose, no adverse events noted.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,synthroid hormone patch- Dotti Emgalty Vit D Vit C Vit B biotin calcium,none,hashitomotos throiditis migraines diarrhea hiatal hernia,,tetracycline- severe diarrhea and erratic heartbeat erythromycin-severe diarrhea and erratic heartbeat biaxin wool mole hair cashmere nylomn,"['No adverse event', 'Product preparation error']",1,PFIZER\BIONTECH,IM 924333,MD,46.0,F,"I had a little redness and swelling at the site 2 days after vaccine was given. It cleared up then today (day 8 after vaccine) the site was itchy, red and very swollen, warm to touch. I also noticed my armpit being sore on the same side as well as a swollen lymph node in my neck on that side.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,"Tylenol, Advil",None,None,,None,"['Axillary pain', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Lymphadenopathy']",1,MODERNA,IM 924334,KY,41.0,F,"states had sudden onset flushing from chest to head, increased pounding heart rate, difficulty swallowing, tightness, numbness in throat, extreme anxiety, approximately 45 minutes after vaccine lasted 5-10 minutes, however the swallowing issue lasted 2-3 hours States did not seek medical treatment, symptoms resolved on their own",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,PVT,Evamist,none,,,None,"['Anxiety', 'Discomfort', 'Dysphagia', 'Flushing', 'Palpitations', 'Pharyngeal hypoaesthesia']",1,MODERNA,IM 924336,SD,50.0,F,"Extreme fatigue, chills, headache and body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Effexor,COVID 19 Positive 12/15/2020,none,,none,"['Chills', 'Fatigue', 'Headache', 'Pain']",1,MODERNA,IM 924337,OK,68.0,F,1530 received the dose; 1540 began having to clear the throat 164/104-69-20; 1547 increase cough; 1549 slight chills given warm blanket and given Solumedrol 125mg IV and Benadryl 25mg IVP. She had pre-medicated with Benadryl 25mg and 2 tablets of Pepcid,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Lipitor 10 mg; metoprolol 50 mg,none,"hypertension, hyperlipidemia, premature atrial contractions",,"PCN, Sulfas, erythromycin, ionic contrast dye","['Chills', 'Cough', 'Throat clearing']",1,MODERNA,IM 924338,NY,26.0,F,"Pt states feeling flushed, lightheaded, tingling in hands, chest and feet, and heart racing/palpitations.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,Nortriplyine - 75mg po once daily Multivitamin - once daily,pt denies any illness at time of vaccine and up to one month prior,chronic migraines,,pt denies,"['Dizziness', 'Hot flush', 'Palpitations', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 924339,NY,61.0,M,Ringing in my ears. Very strong stronger than any other time in my life.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,PVT,"Amlodipine 10mg, Quinapril 40, Simvastatin, flomax 0.8, Aspirin 81mg, Mycobalamin 1000 , Metformin 2 grams, glimepiride 8 mg, tresiba 58, contrave , qunol coq10.","HTN, Diabetes mellitus type 2",bladder neck constriction,,nkda,['Tinnitus'],1,MODERNA, 924340,TX,48.0,F,"C/O dizziness, throat swelling sensation, throat soreness, throat tightening, itching near the eyes, light-headedness. Client can swallow water without difficulty. No SOB noted. RR-20, O2 sat 97%; HR 105; BP 110/76. Per auscultation, no stridor noted. EMT at vaccine facility present and requested EMT support. 2:15 PM Ambulance arrived. EMT evaluated and recommended transport. Pt. declined transport. 2:25 HR 104; BP 110/80; 97% Patient stood without lightheadedness and ambulated on own with sister accompanying to personal vehicle. Gait steady.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,,,"High Cholesterol, hypothyroidism",,"Shellfish, Iodine, Fish","['Dizziness', 'Eye pruritus', 'Oropharyngeal pain', 'Pharyngeal swelling', 'Throat tightness']",1,MODERNA,IM 924341,PA,54.0,F,"After vaccine patient reported ankle, leg and hip pain. Taking Motrin",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,unknown,unknown,unknown,,unknown,"['Arthralgia', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 924342,TX,28.0,F,"Moderna COVID-19 Vaccine EUA 01/05/21 started itching on injection site, 01/06/21 @07:20am noticed redness and hot to touch on injection site, @08:30 started with pain and right arm feeling heavy with swelling. @ 11:05 am noticed injection site swollen (like a large welt and hot to touch). Currently at 4:48 pm injection site still swollen (RED) and hot to touch. Right arm has pain and heaviness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PUB,motrin 600mg x 1 albuterol 1mg (rescue inhaler),none,Asthma,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Limb discomfort', 'Pain in extremity', 'Peripheral swelling', 'Urticaria']",1,MODERNA,IM 924343,CA,29.0,F,"30 minutes after injection of vaccine, I developed tightness in my throat (not severe). This persisted for approximately 1 hour. Later in the evening around 1830, I developed chills and body aches. When I woke up the next day, all symptoms were gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,Zarah (birth control),no illnesses,no prior health conditions,,NKA,"['Chills', 'Pain', 'Throat tightness']",1,PFIZER\BIONTECH, 924344,TX,37.0,F,"itchy, redness and hot to touch at site. Lymph node pain and enlargement under armpit or right arm where the vaccine was administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,OTH,none,none,none,,no,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 924345,WA,36.0,F,Swollen lymph nodes in arm pit and breast with pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/27/2020,4.0,WRK,,,,,,"['Breast pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 924346,VA,43.0,F,"12 hours after shot I developed a headache that quickly progressed into a migraine. Usually going to bed helps but the pain was so bad on the right side of my head I could not sleep. 5 hours after onset of migraine I began vomiting frequently for about 6 hours. Headache and nausea lasted . Was able to sleep on and of. Still feel nausea and weak with slight headache, 24 hours after onset",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Biotin, Vit D, celexa. And Tysabri",None,MS,,None,"['Asthenia', 'Migraine', 'Nausea', 'Sleep disorder', 'Vomiting']",1,MODERNA,SYR 924347,KS,22.0,F,"Patient received Moderna vaccine on 12/29/2020. Complained of slight soreness the next day and then resolved. Patient reports she noticed sore, red raised area last evening, almost 1 week post injection. Area measures 4cm x 3cm induration. Area is not warm to the touch. Patient denies any other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,"Apri, Lexapro, Protonix",None,GERD; Anxiety,local reaction to flulaval on 10/2/2020 that resolved within 1-2 days.,"Clindamycin, Amoxicillin, and Augmentin","['Erythema', 'Induration', 'Pain', 'Swelling']",1,MODERNA,IM 924348,AK,53.0,M,"This is a late entry note regarding adverse reaction status post Pfizer COVID-19 vaccine which was given to the patient yesterday at 9:45. Secondary to the patient's past medical history he was advised that he would wait and observance for approximately 1/2-hour instead of 15 minutes. At approximately 10:15, 30 minutes after receiving his vaccine, the patient did report tingling and numbness in his lips and mouth, this progressed to tightness in his throat at 10:45, the patient denied any shortness of breath or wheezing and was constantly monitored by emergency medical services as a vaccine clinic to take place at our local fire hall. Secondary to throat tightness, and chills, and ongoing tingling numbness in his lips and mouth. #18 IV was started in the right AC, normal saline 1000 cc was up open, the patient received 25 mg of IV Benadryl per protocol, as well as 125 mg of IV Solu-Medrol at 1055. Vital signs at that time 168/95, pulse was 73, and O2 saturation was 100%. Physical exam did not reveal any indication of blockage within the throat, there was no shortness of breath or wheezing. Lung sounds are clear but diminished to auscultation bilaterally, heart rate regular. Temp 98.2. Approximately 10 minutes after receiving medication blood pressure 161/100, pulse-73, sat remained 100. Assessment of patient's symptoms patient does report that the throat feels slightly thicker, he denied any shortness of breath or wheezing, there was no oral or facial edema throughout the entire episode. The patient received 1000 mg of IV Tylenol at 1125. Continued observation for the next hour, the patient did report improvement in his symptoms, lip tingling and numbness dissipated, along with throat tightness. Vital signs at 1236 122/74, pulse 79 oxygen saturation 100%. The patient was placed on a cardiac monitor the entire time of this incident. Follow-up phone call to patient on 01/06/2021 at 8:00 patient reportedam that he did have 1 further episode of tingling in the tip of his tongue and around his lips yesterday afternoon at 16:00 he did take Benadryl as instructed and this dissipated, he reports throughout the night he has had no further episodes of tongue or lip tingling, throat tightening shortness of breath or wheezing difficulty swallowing. He was instructed prior to leaving the vaccine administration site to continue with Benadryl 25 mg every 6 hours, along with Tylenol alternating with ibuprofen per box instructions to aid with chills and rigors for the next 24 hours. He reports that he is had an improvement in his symptoms, We will follow-up again in 1 day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2012,01/06/2021,3289.0,PVT,albuterol 90mg 2 puffs every 4-6 hours as needed for sob/ wheezing Multivitamin 1 tablet by mouth once daily Omega -3 1200 mg 1 capsule by mouth twice daily Aspirin 81 mg 1 tablet by mouth once daily Levothyroxine 150 mcg 1 tablet by mouth,The patient has had no other viral illnesses 1 month prior to this immunization his past medical history does include cardiomyopathy and asthma.,His past medical history does include cardiomyopathy and asthma,,NKDA,"['Cardiac monitoring', 'Chills', 'Hypoaesthesia oral', 'Paraesthesia oral', 'Throat tightness']",1,PFIZER\BIONTECH,IM 924349,CO,46.0,F,Patient received COVID-19 Vaccine 12/19/2020 at 7:30 am. Did well during the 15 minute observation period. Upon returning home started to experience dizziness. Patient has history of (Persistent Postural Perceptual Dizziness (PPPD and Vestibular migraine.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/19/2020,0.0,PVT,,,,,,"['Dizziness', 'Vestibular migraine']",1,PFIZER\BIONTECH,IM 924350,CO,81.0,M,Paralzed from the waist down upon entering bed at 10 pm Couldn't get in or out of bed at 10:30 Also had trouble during the night to go to the bathroom,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,Pneumonia,AFib Diabetes,,None,['Paraplegia'],UNK,PFIZER\BIONTECH, 924351,VA,50.0,F,"My arm was sore for about 3 days. On day 8, the area of the injection became red, raised and itchy much like a mosquito bite. There felt like a 2.5 inch hard knot under the skin and it felt warm. Day 9, still slightly itch, smaller red area, not raised, no 'knot'. Sore when area pressed. No longer warm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,PVT,"Mobic, Flonase, Zyrtec, Wellbutrin, Pristiq Vit. D, Zinc, Melatonin, magnesium, Quercetin, B12 complex, Iron",none,"Mixed Connective Tissue Disorder, Raynaud's, Seasonal Allergies, Essential tremor",,"Codeine, Nsaids","['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Pain in extremity']",1,MODERNA,IM 924352,,43.0,M,"Employee rec'd COVID vaccine. Monitor for adverse reaction. Employee c/o tingling in lips/no swelling noted upon assessment. No other complaints offered, VS taken at 1757 BP 128/74 HR POX 98 Rapid response/ER offered-refused, Continue to monitor Last VS taken 1828 BP 133.77 HR 82 POX 100 Employee reports tingling in lips to be minimal/no swelling no other complaints offered Refusing rapid response/ER eval DC'd from monitor area",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,UNK,,,,,,['Paraesthesia oral'],UNK,PFIZER\BIONTECH, 924353,OK,44.0,F,Arm has red swollen ring around the injection site with a fever a week after getting the vaccine. I also had this reaction the day of the vaccine but it went away and now a week later it is back. Not sure if I should be concerned or if this is normal.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,OTH,"Adepex, Vitamin D and Spironoloctone",none,none,,Sulpher,['Injection site swelling'],1,MODERNA,SYR 924354,MN,50.0,F,"Dizzy, Nausea, Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,"Synthroid, Fish Oil, Vit C, B, Magnesium, Calcium, Progesterone",None,"Rheumatoid Arthritis, Lupus, Sjogrens, Hypothyroidism, Menopause",,"Sulfa, EES","['Chills', 'Dizziness', 'Nausea']",2,MODERNA,IM 924355,MI,41.0,F,LEFT ARM PAIN AND NUMBESS IMEDIATELY POST VACCINATION.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/19/2020,0.0,PVT,"FLONASE, MOTRIN, ZANAFLEX",NO,NO,,SULFA,"['Hypoaesthesia', 'Immediate post-injection reaction', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 924357,OR,33.0,F,I started getting a mild left sided headache that progressively worsened and it became unbearable. No medication helped and it became so severe that it would wake me up at night. I was seen in the urgent care and PCP office and was diagnosed with cluster headaches. I am still experiencing these symptoms. I never had any type of headaches.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/29/2020,6.0,PVT,,,,,None,"['Cluster headache', 'Computerised tomogram normal', 'Headache']",1,PFIZER\BIONTECH,IM 924358,HI,39.0,F,PERIORBITAL AND SCALP ITCHING,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/20/2020,1.0,PVT,NONE,NONE,NONE,,REMOTE HX OF ALLERGIES TO PEANUTS BUT TOLERATING IT NOW,"['Eye pruritus', 'Pruritus']",1,PFIZER\BIONTECH,IM 924359,WA,46.0,F,"Ongoing heart palpitations, breathlessness, tremulous hands, jittery feeling, sweating, PMS symptoms earlier and worse than usual. EKG showed PVCs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/26/2020,3.0,PVT,"Tretinoin cream 0.025%. Vitamin D. Vitamin B12. Fish Oil. Turmeric. Multiple other herbal tinctures, teas, and supplements.","No, but noteworthy is that my pms symptoms started about 2 weeks earlier than usual. They started within a couple days after the vaccination. And they were markedly increased from usual. I'm 46 years old and this has never happened.","Very healthy! Very engaged with my health. Vegan. Daily exercise, Never user of nicotine, drugs, alcohol. Family support. Positive person. I was over-the-moon excited to get the vaccination, and I'm definitely getting the 2nd dose, even though I'm wondering if the vaccine is related to my new disturbing heart palpitations.",,Fluoroquinolones - tendinopathy,"['Dyspnoea', 'Electrocardiogram abnormal', 'Feeling jittery', 'Hyperhidrosis', 'Laboratory test', 'Palpitations', 'Premenstrual syndrome', 'Tremor', 'Ventricular extrasystoles']",1,PFIZER\BIONTECH,IM 924360,PA,38.0,F,"Redness at injection site, slightly raised area approximately the size of a quarter, and warm to the touch. Afebrile. Saw Provider via Telemedicine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/06/2021,8.0,WRK,,,,,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 924361,CA,29.0,F,1/5/21 @8AM: Immediate soreness at site of injection. Unable to sleep through night after injection ~1/6/21 @3:30AM: woke up with chills and sweats,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Probiotic Zoloft 50mg Prenatal vitamin Generic Zyrtec Benadryl 25mg,None,OCD Asthma IBS,,None,"['Chills', 'Hyperhidrosis', 'Immediate post-injection reaction', 'Injection site pain', 'Insomnia']",1,MODERNA,SYR 924362,OR,55.0,F,"reported sx started 1/5/21 at 7 am noticed injection site was red, itchy, warm, and hard. took photos. took benedryl at night before med. no change over course of day, size circle 1/5 inches. 1/6/21 states itch has decreased, still red and hard and now a circle around it making total size 3 inches and 'most of upper arm'. Suggested applying ice, calling PCP and sending photos from both days. If PCP cannot see to go to urgent care or ED for evaluation and evaluation about getting vaccine injection #2",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/05/2021,7.0,PVT,states none,states none,states none,,states none,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 924364,UT,52.0,F,"PARKING LOT ATTENDANT CAME RUNNING INTO CLINIC STATING CLIENT WAS COMPLAINING OF DIZZINESS, HEART PALPATIONS, AND APPEARED PALE. CLIENT STATED HISTORY OF LOW BLOOD PRESSURE. BLOOD PRESSURE TAKEN ABOUT 1420. 120/90. EMT NOTIFIED THAT THEY MAYBE NEEDED. EPINEPHRINE BROUGHT TO CAR. ENCOURAGED CLIENT TO TAKE SLOW, DEEP BREATHS. AFTER 10 MINUTES, STATED FELT MUCH BETTER. PARKING ATTENDANT STATED CLIENT'S COLOR HAD RETURNED. ENCOURAGED TO WAIT FOR ANOTHER 10 MINUTES BEFORE DRIVING AWAY.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,UNKNOWN,UNKNOWN,STATES HAS HISTORY OF LOW BLOOD PRESSURE,,UNKNOWN,"['Dizziness', 'Pallor', 'Palpitations']",1,PFIZER\BIONTECH,IM 924365,MT,56.0,F,"Patient reported redness and swelling at injection site the day after vaccination associated with pain and feeling of inability to move her arm. Today, 1/6/21, patient reports improvement of symptoms. She still has redness, swelling, and pain at the site though.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,MIL,,,,,,"['Injected limb mobility decreased', 'Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 924366,AZ,34.0,F,Nose bleed that stopped within a few minutes,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,OTH,"Metformin, wellbutrin, levothyroxine, liothyrine,",Hypothyroidism PCOS Depression Anxiety,,"Body aches, Fever, fatigue from ProQuad Flu Vax in Aug. 2019","gluten, PCN",['Epistaxis'],1,PFIZER\BIONTECH,IM 924367,CA,39.0,F,"Pain in my left arm, continuous ache, worse when I move it. So far it has not stopped hurting.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,"Multivitamin, vitamin D, Zoloft",No,No,,No,"['Pain', 'Pain in extremity']",1,MODERNA,SYR 924368,,48.0,F,"C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling in nose, lips and mouth and eye lid swelling 12 hours after vaccine was given. Took Benadryl at 2230 and again at 12/29 0430. Called us to report s/s at 10:30 on 12/29. States symptoms are subsiding but still has eyelid swelling. Told to follow up with PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['Chest discomfort', 'Dizziness', 'Hypoaesthesia', 'Nausea', 'Paraesthesia', 'Paraesthesia oral', 'Paranasal sinus discomfort', 'Swelling of eyelid']",1,PFIZER\BIONTECH,IM 924369,KS,42.0,F,"had swelling of mouth, flushed face, treated with 50mg of diphenhydramine. symptoms resolved within one hour",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PHM,,,,,,"['Flushing', 'Mouth swelling']",1,PFIZER\BIONTECH,SYR 924370,CA,59.0,F,"Post vaccination I waited required 15 minutes. Upon exiting building, presented with sever dizziness, near syncopal episode, blurred vision, chest tightness, tachycardia, weakness, shortness of breath. . Returned to vaccination room, in obvious distress. Ushered by staff to chair. Unable to obtain BP via electronic machine, obtained manual , after about 10 or so minutes NIPB 106/69. Remained in room for 45 more minutes, symptoms slowly resolved. Remained with mild to moderate dizziness x 4 days. Headache, chills, chest tightness, weakness, lethargy, x 7 days..",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,None,None,Arthritis Migraines,,None,"['Asthenia', 'Chest discomfort', 'Chills', 'Dizziness', 'Dyspnoea', 'Headache', 'Lethargy', 'Presyncope', 'Tachycardia', 'Vision blurred']",1,PFIZER\BIONTECH,IM 924371,TX,23.0,M,"Approximately 2 minutes after receiving vaccine, patient exhibited a numbness in the tongue and deeper areas of the mouth. BP 134/80 HR 78. Slight numbness has remained fairly constant at 11:55am. Patient reported symptoms subsiding (or less worrisome). Patient clinically stable. Patient released at 12:10pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,"Vyvanse, T3/T4, VitD",None,Hypothyrodism,,None,['Hypoaesthesia oral'],1,MODERNA,IM 924372,SC,65.0,M,The patient had already had a flu vaccine this season on 9/8/2020 and the nurse who gave it did not see that he had already had one and gave him a second vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"HCTZ, Meloxicam, Tamsulosin",None,Essential Hypertension,,Lisinopril,['Extra dose administered'],,SANOFI PASTEUR,IM 924373,TX,45.0,F,"Approximately 11 minutes after receiving vaccine, patient began experiencing partial numbness to the tip of the tongue. BP 212/126 HR 97 O2=98% @12:00pm. Patient reports that the numbness is subsiding. BP 171/112 HR 86 O2=99% @12:18pm. Patient clinically stable. Patient released from clinic at 12:25pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Vitamins,None,None,,None,['Hypoaesthesia oral'],1,MODERNA,IM 924374,MI,40.0,F,Top of Right shoulder has been very soar and painful. This is week 3 of symptoms. My range of motion is limited and I have swelling on the top of my shoulder as well. Can hear popping and clicking in my shoulder when I try to do range of motion as well.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,OTH,Ramipril 5mg daily Vitamin C 500mg daily Zinc 50mg daily Vitamin D3 daily Multivitamin daily,None,None,,NKDA,"['Injected limb mobility decreased', 'Injection site pain', 'Injection site reaction', 'Joint noise', 'Swelling']",1,PFIZER\BIONTECH,IM 924375,SD,50.0,F,"COVID-19 Vaccine EUA. Red, raised, warm, and itchy bump. Treatment of Tylenol 1000 mg. Applied Benadryl ointment to affected area.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,levothyroxine,none,none,,none,"['Erythema', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA, 924376,TX,34.0,F,half dollar size swelling at the injection site with mild erythema and tenderness. No treatment needed. Swelling and tenderness is going down over time.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,"multivitamin, probiotic, elderberry gummies",none,eczema,swelling to injection site with allergy shots,none,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",2,PFIZER\BIONTECH,SC 924377,OR,41.0,F,"Pt described a film in throat, tightness in throat, mucus in throat, and reported nausea. HR was 87, BP 142/90 RR 16, O2 sats on RA 99%. Pt was reluctant to seek care but after nausea continued and pt became slightly SOB she agreed and went to the ER for treatment. Pt was treated in ER and discharged home.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,unknown,none,unknown,,no known allergies,"['Dyspnoea', 'Increased upper airway secretion', 'Nausea', 'Throat tightness']",1,MODERNA,IM 924378,VA,30.0,F,"Swollen at the injection site, hard lump the size of half a golf ball, warmness, fever, headache, chills, and backache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,None,None,None,,None,"['Back pain', 'Chills', 'Feeling hot', 'Headache', 'Injection site induration', 'Injection site mass', 'Injection site swelling', 'Pyrexia']",1,MODERNA,SYR 924379,TX,54.0,F,I had off and on body aches and a pretty severe headache for three days but no fever but nausea.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,01/22/2021,32.0,UNK,I take adderall.,No,I have asthma,2018 Flu vaccine /shingles within 10 days of the vaccine,"I am allergic to ibuprofen, morphine and codeine.","['Headache', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,IM 924380,WI,33.0,F,"Anaphylaxis requiring epinephrine and ER visit, no hospitalization required",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Xolair, Breo ellipta, monteleukast, Zyrtec",None,Asthma,Flu shot with latex cap resulting in anaphylaxis,"Yes; banana, almond, pineapple, dilaudid, flouroquinolones",['Anaphylactic reaction'],2,PFIZER\BIONTECH,SYR 924382,KY,60.0,F,"When given shot I immediately had a hot lightning pain shoot all the way to my elbow. It went away quickly. About an hour after my lips and face felt like it was tingling. The following day I felt severe body ache, low grade fever, and headache. At times my face still feels funny and I have had a headache every day for the past 6 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,OTH,"Benazapril, aspirin, calcium, magnesium,zinc , vitamin D, probiotics",I received a pneumonia vaccine on 12/11/20. I was covid positive on 12/14/20 in isolation quarantine until 12/24/20,I have diabetes that is controlled by diet and exercise. No medication.,,"Sulfa and some antibiotics. Peanuts, tree nuts and shell fish","['Facial discomfort', 'Headache', 'Immediate post-injection reaction', 'Injection site pain', 'Pain', 'Paraesthesia', 'Paraesthesia oral', 'Pyrexia']",1,MODERNA,SYR 924383,MA,49.0,F,"I had the vaccine on the 23rd December I was monitored for 15 mins. My throat felt scratchy and itchy, I left at 3pm by 3:15 my head started hurting, mild. at 7pm I had a pounding headache, chills, body aches on the 24th AM I could not warm up my body was shivering I went to work at 8 am I thought I had a fever and I checked it was 100.2 when I got home my temp was 101 and 102.9 and my body aches were horrible I couldn't move nausea no appetite, shortness of breath, I did a telemed and talked to my primary and she said this was all related to the vaccine, she prescribed something for the nausea was asked to get a covid test and it came back negative, I started getting better Dec 27th .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"Vizal , tylenol",history of asthma,"asthma, interstitial fasciitis",,"skin fruits, wheat","['Chills', 'Decreased appetite', 'Dyspnoea', 'Feeling cold', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Throat irritation']",1,PFIZER\BIONTECH,SYR 924384,,25.0,F,"Shortly after receiving the Covid vaccine EE states she has a dry throat, water given, the stated, ""It feels like it did when I had my allergic reaction to Gain detergent. Seriously feels like I have cotton balls in my throat and it seems to be getting worse. Rapid response team notified, observed, monitored and reassured EE BP 156/74 HR 89 O2 sat 99%, BP 141/70 HR 81, O2 sat 99% EE was allowed to go home after close obs for greater than 30 min EE states she felt anxious and just wanted to go home, her mom was picking her up and bringing Benadryl with her",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/20/2020,0.0,UNK,,,,,,"['Anxiety', 'Dry throat']",UNK,PFIZER\BIONTECH, 924385,OH,30.0,F,"3 hours after vaccine had chills, fatigue, flush face, and body aches- only lasted about 4 hours. But the next day had chest pain and heart palpitations",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,PUB,Unknown,Unknown,Denies,,Ancef (antibiotic),"['Chest pain', 'Chills', 'Fatigue', 'Flushing', 'Pain', 'Palpitations']",1,MODERNA,IM 924386,CO,40.0,F,"I received the vaccine at 1050hrs on 12/16/20. At around 0900hrs on 12/18/20, I began to experience severe fatigue. At ~1330 on the same day, I had a mildly elevated temperature - normal baseline for me is 97.6, with that reading at 99.4. Due to the fatigue, I slept from 1400 hrs until 0500 on the following day, 12/19/20. No other symptoms to report besides a tender injection site for the first 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/18/2020,2.0,PVT,,,,,,"['Body temperature increased', 'Fatigue', 'Hypersomnia', 'Injection site pain']",1,PFIZER\BIONTECH,IM 924387,OH,45.0,M,"Onset of symptoms: 01/04/2021@12:00PM Temperature: 102F Fatigue, muscle ache, diarrhea, nausea, ""heaviness in the chest"" Individual was tested yesterday to rule out COIVD19 with PCR (molecular test) and the antigen test. Both test came back today: negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,PUB,,,,,Penicillin,"['Body temperature increased', 'Chest discomfort', 'Diarrhoea', 'Fatigue', 'Myalgia', 'Nausea', 'SARS-CoV-2 test negative']",UNK,MODERNA,IM 924388,LA,39.0,F,"Pain, tenderness, swelling, and knot at the Injection site. Also a headache for more then 29 hours, fever, nausea, vomiting, dizziness, muscle and joint pain, fatigue, difficulty catching my breath.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,SEN,None,"Difficulty breathing, asthma, sinsus",Asthma,,Topamax,"['Arthralgia', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Headache', 'Injection site nodule', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 924389,TN,52.0,F,"Redness,hardness,and inflammation became present at right deltoid immediately after injecting vaccine. After pt sat in vehicle with medical staff present redness disappeared and knot still present. Pt not in distress or discomfort. Pt left in passenger seat with husband driving approximately 10:50AM.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,Epipen Bre Ellipta 200-25mcg INH Ventolin Inhaler (2 puffs/day as needed) Montelukast Sod (10mg/1xday) Vitamin D2 (1.25mg/1x week) Levothyroxine (50mcg 1x/day AM) Xildra 5% (1 drop per eye 2x day) Nature's Truth Iron o/c (65mg/1x day) Alle,None,"Palandromic rheumatism(fibromyalgia, chronic fatique, arthritis symptoms) Thyroid nodules Meniere's Disease (completed treatment) Mild hearing loss,hyperacuasis Asthma, associated with allergies Chronic Dry Eye TMJ (completed 3 years of treatment) Seborrheic Dermatitis Plantar Fascisitis",,"Restasis-anaphylaxis-active ingredient,cyclosporin Iodine Contrast: throat swelling Decadron: extreme pain Cleocin: rash,vomiting Amoxicillin: rash,vomiting Meds containing specific ingredients: gluten,sulfates,corn,mold,soy,MSG,squash,shrimp","['Immediate post-injection reaction', 'Injection site erythema', 'Injection site induration', 'Injection site inflammation', 'Injection site nodule']",1,MODERNA,IM 924390,CA,40.0,F,"I started seeing a squiggly bright circle. It started as a spot then grew to a bright outlined circle. I also started to get a headache. I took 3- 200mg ibprofen. About 10 minutes later, the vision problem went away.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,None,None,,Sulfa antibiotics,"['Headache', 'Visual impairment']",1,PFIZER\BIONTECH,SYR 924391,MO,44.0,F,"Pounding headache, neck pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,"Diabetes, cancer",,,,"['Headache', 'Neck pain']",1,PFIZER\BIONTECH,SYR 924392,NC,30.0,F,"Chills, fever 101.5 (oral), headache, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,NONE,Tested positive for Covid on 12/07/2020,NONE,,NONE,"['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 924393,OH,72.0,U,No reaction or side effects.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,,,PUB,"Diazide, Valium, Tylenol w/codeine, Lisinopril,Oxybutynin, Trazadone,Biotin,Vit.C,Vit. D3, Colace, Multiple Vitamins,Echinacea/goldenseal,Fiber cap,Vit K2, Calcium,Fibrolief,CBD oil","Fibromyalgia, Osteopenia, Osteoarthritis","Fibromyalgia, Osteoarthritis, Osteopenia",,Chlormycetin,['No adverse event'],1,MODERNA,IM 924394,AZ,27.0,F,Facial swelling angioedema,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Lexapro Levothyroxine,No,Hypothyroidism,,No,"['Angioedema', 'Swelling face']",UNK,PFIZER\BIONTECH, 924395,MN,48.0,F,"Pfizer-Biotech COVID-19 Vaccine EUA Vaccine administered 12/30/20 1202 PM Starting 1/1/2021 - mild headache, numbness in both hands but more significant in the left hand, left foot numbness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,WRK,None,none,none,Similar reaction to influenza vaccine. Tolerates FLUBLOCK or egg free vaccine,None known,"['Headache', 'Hypoaesthesia']",1,PFIZER\BIONTECH,IM 924396,AZ,62.0,F,Syncope,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,,,,,Venafer,['Syncope'],1,PFIZER\BIONTECH,IM 924397,OK,68.0,F,Received vaccine at 1545; c/o itching and rash at 1556 bp 186/82-78 anxious; 1559 Benadryl 50 mg po given; rash red and raised scattered across hand and torso; 1606 146/74-68-20 rash is flat and better less itching; 1623 165/66- 84; 1630 pt itching on right upper extremity and whelps noted. Soumedrol 125 mg IV given; 1702 feels better and rash less red; 1711 resolved,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Norvasc, Lovasa, HCTZ, Omeprazole; Multivitamin; Vitamin C, Zinc, Garlic tablet,",None,Hypertension,,Aspirin,"['Anxiety', 'Pruritus', 'Rash', 'Rash erythematous', 'Rash papular', 'Urticaria']",1,MODERNA,IM 924398,FL,66.0,F,"fever, chills, shivering, headached, body aches, joint aches, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,"multivitamins, omega 3, vitamin d, probiotic, restasis, atorvastatin 10 mg",none,osteoarthritis,,none,"['Arthralgia', 'Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,SYR 924399,FL,57.0,F,"On day 9 post vaccine my injection site became hard, began to itch, ache ,swell and is hot to touch. Issue is ongoing as this is reported. Taking Benadryl and applying cortisone to the area.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,WRK,"probiotics, vitamin D3/k2 fish oil",,Chronic cyclic benign neutropenia,,NKA,"['Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 924400,AK,30.0,F,"CO came to me at 1105 C/O fast heart beat and feeling a little SOB, thinking she was possibly having an anxiety attack. She was scared to get the COVID-19 vaccine. Then she said she did feel SOB and throat feels tight. I grabbed the EPI pen and injected 0.3mg into lateral right thigh. Brought patient to our emergency room, administered Benadryl 25mg (2 caps) po. Started IV NaCl 1000 mL in RAC. Administered famotidine 20mg/2ml IPV over 2 minutes. Currently on slow IV drip, 2nd bag. Patient is doing well. She was initially shaky after the EPI pen but throat did not feel tight less than 10 minutes after injection. Currently is relaxed as I monitor her. Vitals have been stable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,"None today, last night she took Vitamin C, Vitamin D and multivitamin","Stuffy nose, possibly from environmental allergy, Had flu shot, Fluarix on 12/1/2020. No side effects from flu shot.",Anxiety,,"NKDA, no food allergies, + seasonal allergies, like pollen and environment","['Blood glucose', 'Dyspnoea', 'Haemoglobin', 'Heart rate increased', 'Throat tightness', 'Tremor']",1,MODERNA,IM 924401,,,M,severe fatigue body ache chills,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/03/2021,1.0,UNK,,,,,,"['Chills', 'Fatigue', 'Pain']",1,MODERNA,SYR 924402,IN,26.0,F,"The following day, 01/05/2021, I had extreme fatigue, a fever of 100.5, and nausea. The fever subsided by the following day, 01/06/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,UNK,,"Positive for covid one month prior, December 8th",,,,"['Fatigue', 'Nausea', 'Pyrexia']",1,MODERNA,SYR 924403,WA,38.0,F,"Provider arrived for her Covid vaccine. After vaccine was administered she had an immediate localized reaction of tenderness and slight redness. No other symptoms. Provider was placed in the observation area and given and ice pack for the area and made aware that we do have oral Benadryl available. After about 2-3 min Genoveva alerted me that she was now having some itching/scratchiness to the back of her throat and requested Benadryl. 25 mg PO with water was administered and she was immediately escorted to the ED for evaluation with an RN, per protocol.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,,,,,fentanyl,"['Erythema', 'Immediate post-injection reaction', 'Local reaction', 'Tenderness', 'Throat irritation']",1,PFIZER\BIONTECH,IM 924404,CA,33.0,F,"Body aches, sore arm, cold sweats, fever, fatigue, feeling over heated, and loss of appetite.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PVT,Ortho Tri-Cyclen Lo,None,None,,NKDA,"['Cold sweat', 'Decreased appetite', 'Fatigue', 'Feeling hot', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 924405,WV,52.0,F,"LEFT DELTOID AREA WHERE PT HAD COVID VACCINATION HAS SMALL RED RASH 5 INCHES BY 5 INCHES NOT RAISED NO WHELPS. DENIES ANY FEVER, SHORTNESS OF BREATH, ITCHING.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/05/2021,6.0,PVT,,12/2/2020 COVID POSITIVE PCR,,,"ASPIRIN, AUGMENTIN, CIPRO, ERYTHROMYCIN, LEVAQUIN","['Injection site reaction', 'Rash erythematous']",1,MODERNA,IM 924406,MN,41.0,F,"Shortly after vaccination, client felt slight tightness in the chest and shortness of breath. Approximately 5 minutes after vaccination, client began having tingling in the right arm (same arm as vaccination). Tingling spread to head and neck area and client began to feel warm. O2 saturations were 100%. Pulse was normal. Client had a general feeling of ""unwell"". Client was monitored for 30 minutes after vaccination. Symptoms were stable, and client was sent home with husband. Instructions given to client to watch for worsening symptoms and call their healthcare provider if symptoms worsen.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PUB,Losartan,,,,Oranges,"['Chest discomfort', 'Dyspnoea', 'Feeling hot', 'Malaise', 'Paraesthesia']",1,MODERNA,IM 924407,TX,49.0,F,"First 2 days after vaccine, arm soreness at site of vaccine, resolved. Starting on 01-05-21 (8 days post vaccination) developed headache, runny nose and sore throat. On 01-06-21 reports small amounts of coughing. Will go for COVID testing tomorrow 01-07-21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,OTH,"Diflucan, Crestor QD, Vitamin C, D, & E, Cranberry, Fish Oil, Probiotic",Recurrent yeast infection,None,,"Bactrim, Ceftin, Doxycycline. Seasonal allergies","['Cough', 'Headache', 'Oropharyngeal pain', 'Rhinorrhoea', 'Vaccination site pain']",1,MODERNA,IM 924408,,41.0,M,"Dr walked into employee health requesting steroids. States has already taken Benadryl. Reddened rash with hives noted arms and neck. States he doesn't want to go to the ER just needs RX for steroids. Noted to his coworkers, RX number given. Rec'd Covid vaccine on 12/20/2020",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/23/2020,3.0,UNK,,,,,,"['Rash', 'Rash erythematous', 'Urticaria']",UNK,PFIZER\BIONTECH, 924409,OR,39.0,F,"10 MINUTES after the injection, I became very hot and flushed, with headache, palpitations, weakness, and shortness of breath. I sat down, my heart rate was 110 on my I watch. I was breathing heavy and feeling sweaty. The healthcare providers had me lie down on a stretcher and gave me oxygen with my feet elevated. After about 20 minutes, I felt better. Later that day, I came home and slept for 2 hours. The next day, (today) I came home early from work because I feel very tired and having difficulty concentrating. But the other symptoms have gone away.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Seroquel, Mirtazapine, Buprenorphine, Ativan, Baclofen",none,none,,"gabapentin, Lyrica","['Asthenia', 'Disturbance in attention', 'Dyspnoea', 'Fatigue', 'Feeling hot', 'Flushing', 'Headache', 'Hyperhidrosis', 'Impaired work ability', 'Palpitations']",1,PFIZER\BIONTECH,IM 924410,SD,76.0,M,Adult failure to thrive; Chronic hypoxemic respiratory failure; Generalized weakness,Not Reported,,Not Reported,Yes,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,"AMLODIPINE BESYLATE 5MG TAB ASPIRIN 81MG EC TAB LEVOTHYROXINE (SYNTHROID) 88MCG TAB TAMSULOSIN HCL 0.4MG CAP FLUTICASONE 500MCG/SALMETEROL 50MCG INHL DISK 60 ROSUVASTATIN CA 20MG TAB CHOLECALCIFEROL 25MCG (1,000UNIT) TIOTROPIUM 2.5MCG",,"Hypertension, COPD with oxygen dependence, hypothyroidism, osteoporosis",,None,"['Adult failure to thrive', 'Asthenia', 'Respiratory failure']",1,MODERNA,IM 924411,CA,34.0,M,"Reported feeling flushed, increased heart rate tingling fingertips difficulty focusing eyes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Zoloft 150mg,n/a.,Panic attacks and anxiety,,"Celcor, PCN","['Flushing', 'Heart rate increased', 'Paraesthesia', 'Vision blurred']",1,PFIZER\BIONTECH, 924412,CA,56.0,M,pain from my arm up the shoulder to the head on back of my left ear and rash on my arm and around my neck.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,WRK,none,none,neck and lower back pain,,none,"['Pain', 'Rash']",6,MODERNA,SYR 924413,MS,38.0,F,RECEIVED FIRST DOSE MODERNA COVID. LOCAL SITE REACTION APPEARED TO BE CONSISTENT WITH CELLULITIS,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"ZOFRAN, LIPITOR, LEXAPR, TRAOZODONE, OZEMPIC, TRESIBA, METFORMIN, CYCLAFEM, ADVAIR, ATIVAN, OLMESARTAN, DUONEB",,"DM, HTN, DYSLIPID,ANXIETY, DEPRESSION",,PENICILLIN,"['Cellulitis', 'Full blood count normal', 'Injection site reaction']",UNK,MODERNA, 924414,,23.0,F,"Chills, fever, headache, muscle aches, fatigue beginning around 3pm 1/5/21 and ending around noon 1/6/21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924415,VA,27.0,M,100.4 fever,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PUB,,,,,,['Pyrexia'],1,MODERNA,IM 924416,,46.0,F,"12/23: developed soreness 12/30: developed runny nose, congestion, cough 12/31: fever 100 deg F and chills",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/23/2020,0.0,UNK,,,,,,"['Chills', 'Cough', 'Pain', 'Pulmonary congestion', 'Pyrexia', 'Rhinorrhoea']",1,PFIZER\BIONTECH,IM 924417,IL,52.0,M,Moderate ankle pain left x 1.5 days Hamstring cramping moderate x 1 day Fatigue - moderate x 1 day,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/21/2020,2.0,PVT,,None,,,Codeine and sulfa,"['Angiogram', 'Arthralgia', 'Fatigue', 'Fibrin D dimer', 'Muscle spasms', 'Peripheral swelling', 'Ultrasound Doppler']",1,PFIZER\BIONTECH,IM 924418,GA,51.0,M,"Vaccination administered at 3:42pm. Member voiced he had a dry throat and was provided water. He was observed for 15mins without any noticeable concerns noted. He was scheduled for his 2nd vaccine and released. Member returned to 2nd floor conference room C at 4:37pm as he indicated his tongue felt thick and swallowing wasn't ""natural"". He advised he sat in his car for a while and came back in and took 2 benadryl. I escorted member down to ACC and handed him off with report. He was in no acute distress, able to talk and ambulate. While checking into ACC he indicated he felt the benadryl was helping and felt a little better. (Initially during the 15 minute observation, member advised his mouth was dry and asked for water, which after drinking he said he was fine and that it helped. He was in no distress at that time. )",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,No medications,Acute Sinusitis December 2019,No past chronic medical history noted,,No known allergies,"['Dry throat', 'Dysphagia', 'Tongue disorder']",1,MODERNA,IM 924419,MS,36.0,F,"I recieved my injection at 1:00pm. My arm became sore around 3:30pm as expected. I became very tired around 5pm. Around 6:30 I experience heat on the left side of my neck up to the back of my left ear. Also tingling, mild swelling, and drooping on left side of face that lasted a couple of hours. The next day I still experienced the heat feeling in left side of neck up to the back of left ear, fatigue, and soreness in arm. But by 3pm I felt fine and haven't had any problems since.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,No,No,No,,No,"['Facial paralysis', 'Fatigue', 'Feeling hot', 'Pain in extremity', 'Paraesthesia', 'Swelling face']",1,PFIZER\BIONTECH,IM 924420,OH,24.0,F,"Fever (102.8�F), improved with Tylenol, lasted about 4 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,Kyleena IUD,N/a,N/a,,"Augmentin, penicillin",['Pyrexia'],1,MODERNA,IM 924421,VT,54.0,F,Severe local rash and pain that started 7 days after administration.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,"Metoprolol, Lisinopril, MVI",Palpitations,"DM II , diet control Htn sp Bariatric Surgery",,,"['Pain', 'Rash']",UNK,MODERNA,IM 924422,TX,49.0,F,"Had sore arm 2 days following vaccine. On 01-05-21 developed headache, runny nose and sore throat. Slight cough on 01-06-21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,OTH,"Diflucan, Crestor, Vitamin C, D & E, Cranberry, Fish Oil, Probiotic",Recurrent yeast infection,None,,"Bactrim, Ceftin, Doxycycline, Seasonal Allergies","['Cough', 'Headache', 'Oropharyngeal pain', 'Pain in extremity', 'Rhinorrhoea']",1,MODERNA,IM 924423,MI,60.0,M,"DIZZY , VOMITING, SWEATING 15 MIN AFTER VACINATION LASTED 5 MIN THEN 2 -3 HOURS OF CHILLS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,"TOPROL XL, FLONASE, VIT B12, ZYRTEC, LIPITOR ASA,NORVASC, ALBUTEROL,",NO,"ALLERGIC RHINITIS. GERD, FATTY LIVER, HYPERLIPIDEMIA,, HTN,",ONCE WITH IMMUNIZATION AS A CHILD,SULFA,"['Chills', 'Dizziness', 'Hyperhidrosis', 'Vomiting']",1,PFIZER\BIONTECH,IM 924424,MA,25.0,F,"6 days after injection developed severe armpit pain and lymph node swelling. Day 7 woke up with hard, red, warm bump below site of injection with excruciating pain and limited arm movement. Seen by MD and started on antibiotics for cellulitis.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,PVT,Birth control,,,,,"['Axillary pain', 'Cellulitis', 'Injected limb mobility decreased', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Lymphadenopathy', 'Ultrasound scan']",1,MODERNA,IM 924425,WA,36.0,F,"Per patient: ""I recieved the covid vaccine on 12/29/2020. Ten minutes later I broke out in a rash from chest down it was a burning and itching and red spots. They took me to ER and gave me medicine. Within 40 mins I felt better so I left to go home. I have been feeling really tired and weak. I went home on the 4th with weakness and I did vomit 1 time. I felt sick to my stomach all day. I came back to work today still feeling nausiated.""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Abdominal discomfort', 'Asthenia', 'Burning sensation', 'Fatigue', 'Nausea', 'Rash', 'Rash macular', 'Vomiting']",1,PFIZER\BIONTECH,IM 924426,CA,33.0,F,"Patient reported Flu-like symptoms and achiness at 12:00 PM on 1/4/21. There was bilateral neck pain and headache at 2:00 AM on 1/5/21, and a hacking cough throughout the day. Patient experienced chills at 6:00AM. Patient called in sick to work on 1/5/21. Patient alternated between ibuprofen and tylenol, and symptoms have seemed to resolve by 3:15 PM on 1/6/2021 3 hours after taking 2 grams of tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Cough', 'Headache', 'Impaired work ability', 'Influenza like illness', 'Neck pain', 'Pain']",1,MODERNA,IM 924427,FL,48.0,F,I experienced rigors and high fever to 105.00 Palpitations Severe headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Headache', 'Palpitations', 'Pyrexia']",1,MODERNA,IM 924428,MI,26.0,F,Pt experienced a pre-syncopal/vasovagal episode. She was laid supine and observed for 25-30 minutes. She began to feel better and was able to sit and then stand with no symptoms. She felt able to leave the clinic on her own and was advised to seek medical attention should symptoms return or worsen.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,['Presyncope'],1,PFIZER\BIONTECH,IM 924429,OK,30.0,M,"Patient had received the Moderna vaccine and was in observation, when he started feeling lightheaded. I took his blood pressure and pulse. BP 115/70, pulse 48. I had him to stay seated and I would check him again. At that time RN came into the room and retook his BP- BP 90/40 P60 R18, Pt then placed onto the floor and feet elevated. Pt became very pale and continued to complain of lightheadedness. we continued to observe pt. Pt explained that he was feeling a lot better. Continued to lay on the floor with feet elevated. BP 138/92 P-62 R-16. Color returned to normal Pt reported that he was feeling better . Placed pt in upright position and RN helped him to chair. RN continued to monitor pt for 15 minutes and pt was sent home. He had no more lightheadedness before he left.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PUB,,,,,,"['Dizziness', 'Pallor']",1,MODERNA,IM 924430,MI,49.0,M,"after 5 minutes states her fingers felt weird -numb and felt like her hear was racing, very anxious started to hyperventilate. Took her to ER via WC . During transfer stated her fingers were twisting (noticed definite contractures in both hands. States her heart was beating very fast. Denies any allergies but did states she has history of low potassium and has had issues with medications nad vaccines in the past. However no sx like this but does get ""a little loopy"" even when taking motrin. Instructed her to notify any provider prior to any vaccinations of the above sx. If I would have know any off this I would have highly recommended her to get authorization from her PCP prior",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,unknown,unknown,unknown,,Nkda,"['Anxiety', 'Feeling abnormal', 'Full blood count', 'Hyperventilation', 'Hypoaesthesia', 'Joint contracture', 'Palpitations']",1,PFIZER\BIONTECH,SYR 924431,UT,43.0,M,"Sweats, body aches, headache on the day of vaccination. Next day the patient experienced regional lymphadenopathy and arm weakness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,PVT,,,,,"levofloxacin, lisinopril, Toradol","['Headache', 'Hyperhidrosis', 'Lymphadenopathy', 'Muscular weakness', 'Pain']",1,MODERNA, 924432,PA,48.0,F,"Started on 4th day, around 3 am, woke up with severe muscle aches, extensive lower back pain(unable to walk properly), dizziness, severe nausea. 5th day- nausea, headache, muscle aches. No fever. 6th day(today) not getting better, still very nauseous, severe headache, dizziness, stomach is upset. Symptoms dont seem to be getting better.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/03/2021,4.0,WRK,"Lexapro, Seroquel, lipitor",None,Asthma- controlled/severe during allergy season,,Severe Seasonal allergies to pollen ( March- June),"['Abdominal discomfort', 'Back pain', 'Dizziness', 'Gait disturbance', 'Headache', 'Myalgia', 'Nausea']",1,PFIZER\BIONTECH,IM 924433,,60.0,F,"Rec'd Covid vaccine after 15 min obs stated she felt ""swooney, dizzy, like"" BP 168/86 HR 68 states she has a hx of HTN she usually runs 120's/70's Monitored for another 25 min BP ranging 157/87 - 173/86, prior to leaving states she was not feeling dizzy anymore BP 164/88 HR 69, and wanted to go back to work. Could not find anyone to take care of her patients and was concerned. Coworker states they would monitor her.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,UNK,,,,,,"['Dizziness', 'Feeling abnormal']",UNK,PFIZER\BIONTECH, 924434,OH,27.0,M,"Vaccine given @ 12:36PM Patient reported feeling hot and dizzy. @12:45PM Pt began shaking and stated he felt weak. BP: 253/149 (Pt was shaking during evaluation) EMS called @ 13:00 Pt left @ 1;14PM with EMS HR: 89, O2 Sat Room Air: 99%",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PUB,Unknown,,Cardiac condition,,Unknown,"['Asthenia', 'Dizziness', 'Feeling hot', 'Tremor']",UNK,MODERNA,IM 924435,MS,30.0,M,"nausea, vomiting, headache, fever, body chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PUB,none,None,None,,Cehclor,"['Chills', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",UNK,MODERNA,IM 924436,,56.0,F,Vaccine injection site developed into a big red welt since 1/4/21. Potential infection. Started on antibiotics 1/5/21.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/04/2021,6.0,UNK,,,,,,"['Injection site erythema', 'Injection site reaction', 'Urticaria']",1,MODERNA,IM 924437,IL,25.0,F,Fever of 100.1,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,None,None,None,,Cipro,['Pyrexia'],1,MODERNA,SYR 924438,CA,39.0,F,"Nausea, Fatigue, Dizziness, Shortness of breath, Lethargic, Soar throat, Swollen tonged, and rash on injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Dizziness', 'Dyspnoea', 'Fatigue', 'Injection site rash', 'Nausea', 'Oropharyngeal pain', 'Swollen tongue']",1,MODERNA,IM 924439,OK,59.0,F,"1740 received the vaccine; 1755 began occasional dry cough and raspy voice noted 168/80-100-20; started IV line and Solumedtrol 125 mg given IV; 1803 continued dry cough voice less raspy states cough less tight feeling; 1815 151/76-88-16 dry cough still; 1826 ambulate in the hallway then increased wheezing, dry cough and raspiness; 1843 given albuterol HHN ; kept her and observed overnight and left in the am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Triamterene HCTZ; Vitamin C; Quecertin; zinc, Vit B1; Vitamin D3; Pepcid; ASA; Symbicort MDI; Proair MDI",none,"Asthma, hypertension",,Cats and pet dander,"['Cough', 'Dysphonia', 'Wheezing']",1,MODERNA,IM 924440,MN,50.0,F,Pfizer-BioNTech COVID-19 Vaccine EUA left arm and leg persistent paresthesias for two weeks,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/23/1920,,PVT,vitamin d supplement,,,,norco,"['Angiogram', 'Angiogram normal', 'Blood folate normal', 'Blood thyroid stimulating hormone', 'Paraesthesia', 'Vitamin B12 normal']",1,PFIZER\BIONTECH, 924441,IL,42.0,F,"Diarrhea ,chills, vomiting/nausea, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Advil,no,no,,,"['Chills', 'Diarrhoea', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,SYR 924442,OR,31.0,F,"I had a little bit of nausea, headache, rapid heart rate the whole time and a sore arm. My estimated date of delivery is 04/25/2021. I am 23 weeks gestation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,UNK,"I take prenatal vitamins, unisem, vitamin B6, arithromycin, azelaic acid.",No,No,,No,"['Exposure during pregnancy', 'Headache', 'Heart rate increased', 'Nausea', 'Pain in extremity']",1,MODERNA,IM 924443,IL,33.0,F,Sore arm after 2 hours of vaccine given Low grade fever 99.9,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,No,No,Thyroid disease,,No,"['Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 924444,TX,33.0,F,Complaining of scratchy throat consistently clearing her throst. Unable to speak in complete sentenses due to clearing her throat. No shortness of breath and no difficutly breathing. Throat redness minimal and airway patent. Vital signs with in normal limits. No itching or redness noted on body and no hives present. Able to swallow water.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,OTH,,,,Influenza,"Penicillin, Bees, Vodka, Deer, Pineapples","['Aphasia', 'Electrocardiogram', 'Pharyngeal erythema', 'Throat clearing', 'Throat irritation']",1,MODERNA,IM 924445,,47.0,F,"Patient states that about 5 minutes after vaccine they felt ""pins and needles"" sensation in their left arm and hand. Covid vaccine was given in left deltoid. Patient waited 30 minutes after vaccination with no new symptoms. Patient denies the need for any further medical attention. Patient left with a companion.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,['Paraesthesia'],1,PFIZER\BIONTECH,IM 924446,NY,29.0,F,"redness/swelling/firm/tenderness at injection site, lymphadenopathy. starting day 8 post vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/05/2021,8.0,PVT,claritin & prevacid,none,none,,"shellfish, penicillin, sulfa drugs, clindamycin","['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy']",1,MODERNA,IM 924448,CA,37.0,F,Sore arm lasting 24-36 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,WRK,None,,Gastroparesis,,None,['Pain in extremity'],UNK,MODERNA,SYR 924449,,51.0,F,"On 1/5, developed fever 101 F, chills, Headache, back ache, and throbbing pain left arm",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,,,,,,"['Back pain', 'Chills', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 924450,TX,60.0,F,Patient had an asthma attack approximately 45 minutes after receiving the injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,Albuteral Sulfate atorvastatin glimepride hydrochlorothiazide metformin vascepa levothyroxine baby aspirin Singular Losartan,None,Asthma,,None,"['Asthma', 'Condition aggravated']",1,MODERNA,IM 924451,TN,46.0,F,Left arm heaviness with tingling.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,None,None,None,Arm tingling,NKA,"['Limb discomfort', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 924452,IN,42.0,F,"Couldn?t move head/neck without moderate to severe pain, lymph nodes on affected side where injection was give were hard and extremely painful to palpate. Neck and jaw pain day three extremely bad migraine causing me to miss work",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/04/2021,1.0,PVT,None,None,None,,Sulfa,"['Impaired work ability', 'Lymph node pain', 'Lymph node palpable', 'Migraine', 'Neck pain', 'Pain', 'Pain in jaw']",1,MODERNA,SYR 924453,OH,57.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Approximately, 1 hr after receiving COVID-19 vaccine, noted general pruritus without rash, mild scleral injection. No other systemic symptoms. Pt treated with Benadryl 25mg x1. Symptoms resolved within 30-45 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,MIL,,,,,"PCN allergy, also reports hx of pruritus/rash several hours after previous shingrix vaccine","['Ocular hyperaemia', 'Pruritus']",1,PFIZER\BIONTECH,IM 924454,NY,26.0,F,"Patient began having flushing and hives, chest tightness, shortness of breath, voice changes - began ~20 minutes after occurrence. Given IV benadryl 50 mg immediately - noted some improvement of symptoms. Symptoms persisted, arrived in ER, given IM epi 0.3 mg, PO prednisone 50 mg, and PO pepcid 20 mg approximately 1 hour after administration",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,none,migraine headaches,,none,"['Chest discomfort', 'Dysphonia', 'Dyspnoea', 'Flushing', 'Tryptase', 'Urticaria']",1,PFIZER\BIONTECH,IM 924455,OK,76.0,F,"0840 Patient received vaccine. No reported allergies to any medications or immunizations. COVID19 pre-vaccination checklist completed. Patient moved to observation. 0852 patient complained of tightness in throat and slight shortness of breath. 0853 RN took BP 180/100, R 18, P66. Patient was sitting upright and took off jacket. 0858 Patient reports symptoms are the same. BP 172/108. 0859 Patient reports difficulty breathing and continued tightness in throat. RN administered 50mg IM Diphenhydramine. 0908 Patient reports that symptoms have started to improve. Reports continued some tightness but no longer having difficulty breathing. Patient reports that she is feeling some better. Family arrives. Patient explains that she has had the need for Benadryl with insect stings and had extreme reactions to some other items that were not previously reported to RN. Patient was observed and was feeling better. Instructed patient to contact PCP to report reaction and follow-up with PCP. Instructed patient to call 911 immediately with any further adverse reactions after returning home. Family to drive patient home and continue to monitor patient. 1500 patient called back to explain that she was feeling better. Some swelling in tongue. Patient follow-up with PCP today. PCP to continue to follow. No further medication needed at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,Aspirin,,,,Latex,"['Dyspnoea', 'Throat tightness']",1,MODERNA,IM 924456,CA,85.0,F,"Patient did not display any obvious signs or symptoms; the vaccination was administered at approximately 10:00 AM and the patient continued throughout her day without any complaints or signs of adverse reaction. Patient was helped to bed by the nursing assistant estimated at around 9:00 PM. The facility received notification from the lab around 11:00 PM that the patient's COVID-19 specimen collection from Sunday, 1/3/21, detected COVID-19. When the nursing staff went to the room to check on the resident and prepare her to move to a COVID-19 care area the patient was found unresponsive, no movement, no chest rises, noted regurgitated small amount of food to mouth left side, lying on left side. Pupils non reactive.",Yes,01/05/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,SEN,"Lexapro, famotidine, Namenda, Seroquel, simvastatin, Trazodone; Tamsulosin; Docusate sodium; Polyethylene glycol; Celebrex; Acetaminophen",COVID-19 detected after vaccination; asymptomatic,"Hyperlipidemia; Alzheimer's disease; Atherosclerotic heart disease of native coronary artery w/o angina pectoris; Osteoarthritis; Major depressive disorder, single episode, unspecified; unspecified severe protein-calorie malnutrition",,No known allergies,"['Pupil fixed', 'Regurgitation', 'Respiratory arrest', 'SARS-CoV-2 test positive', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 924457,UT,59.0,F,"I?m having pain in my arm pit, with a little swelling. It?s getting worse, and it?s making my arm hurt underneath",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,"Thyroid medication, trazodone, mild high blood pressure medication. Amitrptaline",,,,,"['Axillary pain', 'Oedema peripheral']",UNK,MODERNA,SYR 924458,ME,30.0,M,"Patient experienced significant swelling of arm, back, and facial region, headache, reports kidney pain and lip and throat numbing, as well as overall body aches. Patient took Benadryl 50mg to reduce swelling with success. Symptoms subsided completely after 4 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PHM,Prednisone for back pain.,None,Asthma,,"Shellfish, bees, penicillins, cephalosporins, sulfas.","['Headache', 'Hypoaesthesia oral', 'Pain', 'Peripheral swelling', 'Pharyngeal hypoaesthesia', 'Renal pain', 'Swelling', 'Swelling face']",1,PFIZER\BIONTECH,IM 924459,KS,22.0,F,"Woke up in middle of night muscle arm pain stiffness, headache, nausea. 6 hours later still has fever, 101.1.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PUB,Escitalopram Oxalate,no,no,,no,"['Headache', 'Musculoskeletal stiffness', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,SYR 924460,MI,40.0,F,Very fatigue the next day after vaccine. I had whole body tiredness. My arm was very sore and started about 3am . The site was fine but the deltoid and tricep muscles were very sore.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,None,None,None,,Sulfa drugs,"['Fatigue', 'Injection site pain', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 924462,,47.0,F,"Rec'd Covid vaccine 10 minutes afterwards, employee stated she felt weird in her chest, states she didn't know if it was anxiety, state pain 4/.10 offered employee to be evaluated - refused requested to sit and be monitored BP 132/72, HR 71 POX 98% repeat vs employee states chest tight refused ED eval and RRT B/P 137/77 HR 70 POX 98% still refusing ED state just wants to be monitored for a few minutes 1745 BP 140/79 HR 70 POX 98% final VS at 1751 129/77, HR 70 POX 99% Employee states she feels more comfortable now and is ready to go home. She further states she knows what to do.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,UNK,,,,,,"['Chest discomfort', 'Chest pain']",UNK,PFIZER\BIONTECH, 924463,CA,48.0,F,"Administration Error - upon injection, the needle was not fully injected into the patient's arm. An unknown amount of drug squirted onto the patient's arm and did not make it in. It was recommended to receive another complete dose as we didn't know exactly how much had been received but the patient was uncomfortable with that and she requested we only give her 0.2ml instead of 0.3ml. We drew up another 0.2ml and administered that in addition to what she received initially. No side effects reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,,,,,,"['Exposure via skin contact', 'Intentional product use issue', 'No adverse event', 'Product administration error', 'Underdose', 'Wrong technique in product usage process']",1,PFIZER\BIONTECH,IM 924464,IA,61.0,F,"coughing up blood, significant hemoptysis -- > cardiac arrest. started day after vaccine but likely related to ongoing progression of lung cancer",Yes,01/06/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,,"COPD, lung cancer","COPD, lung cancer",,,"['Cardiac arrest', 'Condition aggravated', 'Haemoptysis', 'Lung neoplasm malignant']",UNK,PFIZER\BIONTECH, 924465,AZ,46.0,F,"Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of right toe. Blood pressure and heart rate mildly elevated beginning around 10:40 pm 1/5/21. Spoke with a triage nurse twice late pm 1/5/21 and early am 1/6/21. Advised self monitoring. Unable to sleep more than about 1 hr at a time-woke up sweaty. No temp. Woke up without dizziness/nausea but had dizziness when eating cereal and looked down. Saw general practice physician 1/6/21 after 10 am 1/6/21. Given anti-dizziness med. prescription. Dizziness/nausea, Tired/heaviness in legs gone when saw physician. Still mild altered sensation in right leg and big toe numbness that comes and goes. Elevated blood pressure at physician. Bloodwork ordered and scheduled for Saturday.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,"Loratadine, lisinopril, Advil, morning complete dietary supplement by Activatedyou.",,High blood pressure seasonal allergies with sinus pain/pressure,,Codiene makes me nauseous. Lately bananas and banana products have caused burning in stomach and some diarrhea.,"['Blood pressure increased', 'Chills', 'Dizziness', 'Fatigue', 'Heart rate increased', 'Hyperhidrosis', 'Hypoaesthesia', 'Insomnia', 'Limb discomfort', 'Nausea', 'Sensory disturbance']",1,PFIZER\BIONTECH,SYR 924466,UT,25.0,F,WHILE WAITING THE 15 MINUTES AFTER VACCINATION CLIENT EXPERIENCED RASH STARTING AT NECK AND THEN PROGRESSING ALL OVER HER BODY. STATES FELT ITCHY. NOTIFIED PARKING ATTENDANT. EMT SUMMONED. DENIED BREATHING DIFFICULTIES. EMT GAVE OXYGEN AND BENADRYL. FAMILY MEMBER CAME TO PICK UP CLIENT AND GIVE RIDE HOME.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,UNKNOWN,UNKNOWN,UNKNOWN,,UNKNOWN,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 924467,MA,44.0,F,"0912: Pt honks horn, this RN immediately to car side. Pt reporting tachycardia. Pulse check 106, BP 154/81. Pt states it came on suddenly, no CP, no SOB, no tongue swelling, no numbness/tingling, no throat itching or swelling. Pt monitored by this RN. After about 5 minutes pt reports feeling like HR coming down, HR 88 BP recheck 160/82. Pt reports no allergies, no adverse reactions to any previous vaccines (has received flu shot and Tdap in last 4 months). Pt did eat this morning. 1000: Pt observed in car, feeling WNL. BP recheck 133/76. Escorted to bathroom by this RN w/out issue. Pt states she feels comfortable driving, symptoms have completely resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,Birth Control,None,None,,None,['Tachycardia'],1,MODERNA,IM 924468,TX,41.0,F,"I had the shot and my only symptom was bruising at the injection site and sore arm. After a few days my arm no longer hurt, but the bruise remained. 6 days after my injection, I experienced mild itching at the injection site. Day 7 I noticed my arm was red, swollen, warm to touch, and itchy. Day 8, my arm continued to swell and the area that was red was larger and very warm to touch at the injection site. My arm was also beginning to feel heavy. I contacted and saw my pcp on day 8 and was told to take an antihistamine. I took clarity and my symptoms are starting to improve.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,PVT,adderall propanolol,none,adhd SVT Graves,,none,"['Injection site bruising', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Limb discomfort', 'Pain in extremity']",1,MODERNA,IM 924469,CA,43.0,M,Soreness in arm,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,['Pain in extremity'],1,MODERNA,SYR 924470,NC,30.0,F,"1215-Noted pt sitting on the floor fanning herself after receiving her COVID vaccine. 1220-Pt ambulates to stretcher for further evaulation of clinic staff, FNP. Patient reported no previous adverse reaction to vaccines, but did note an anaphylactic nut allergy. Pt reported a milder version of the symptoms she is experiencing today after her initial vaccine Dec 17, 2020. Initial HR 64 SPO2 74% room air(employee wearing dark fingernail polish and reporting tingling in her hands) Pt instructed to breath slowly in through nose, out through mouth. 1225 BP 150/95 HR 85 SPO2 99% Pt given some water and crackers and reports eating NO food today other than a few cookies. Pt reports feeling better, color has now returned to pt. 1235- BP systolic 180s. pt advised to be seen in the ED for further evaluation. 1240 patient taken to ED by this RN; FNP; and second RN for further evaluation. 2L SPO2 put on pt en route based on previous low oxygenation. 1245- Pt arrived in ED, pt began reporting blurred vision; handoff to ED staff. Evaluated by ED staff, medicated with 1L NS bolus, 125mg IV Methylprednisone; 20mg IV Famotidine, 50mg IV Benadryl. 1640-employee reported to ED complete resolution of symptoms . Employee discharged from ED with prescription for an Epi-pen and prednisone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,None,None,History of Drug/Alcohol abuse,,Almonds-anaphylaxis,"['Paraesthesia', 'Skin discolouration', 'Vision blurred']",2,PFIZER\BIONTECH,IM 924471,MO,49.0,F,Acute cellulitis on the Left upper arm,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,PVT,,,Leukocytoclastic vasculitis,,,['Injection site cellulitis'],1,MODERNA,IM 924472,VA,51.0,F,"Fatigue, chills fever joint aches and pains along with femur bones aching/hurting as well as my rib cage sore and achey. Fever went as high as 102.4. Plus have noticed a small cough. I received the vaccine on Monday morning and by that evening I could not move with fever and pain. The symptoms started to subside around 4:00 am Wednesday 1/6/2021. Currently it is 18:30 and I feel better temp is 99.1. No joint aches but with a small cough.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Arthralgia', 'Bone pain', 'Chills', 'Cough', 'Fatigue', 'Mobility decreased', 'Musculoskeletal chest pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 924473,MI,40.0,F,Whole body fatigue the next day. Arm was very Sore. The site was fine but the deltoid and tricep was very sore. I have regular yearly flu shots with no issues.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,None,None,None,,Sulfa drugs,"['Fatigue', 'Myalgia', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 924474,KS,22.0,F,"Arm pain muscle stiffness around inj site. Headache, fever, 101.1. 6 hours later still running fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PUB,Escitalopram Oxalate,no,depression,,no,"['Headache', 'Injection site reaction', 'Musculoskeletal stiffness', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 924475,TX,51.0,F,"She had headache after receiving the vaccine, about 30min after, her BP was 150/86, pulse 74; there was no redness or swelling, non-tender, no warmth",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,WRK,unknown,,newly diagnosed thyroid disease,,chemotherapy used for thyroid treatment,['Headache'],1,MODERNA,IM 924477,AR,25.0,F,within 15 minutes she said a bit dizzy I didn't think it was an anaphylactic reaction I told her to follow up in ER if it got worse,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PHM,,,,,,['Dizziness'],1,MODERNA,IM 924479,,26.0,F,"Redness, swelling, hives at injection site. Hives spread down arm and to neck, patient began trembling. Benadryl given patient sent to emergency department. Checked out in ED, HR 110 & reports nausea and headache. Nothing else abnormal. Patient observed and hives seemed to resolve.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Headache', 'Injection site erythema', 'Injection site swelling', 'Injection site urticaria', 'Nausea', 'Tremor', 'Urticaria']",1,MODERNA,IM 924481,AK,27.0,F,"Approx 3 min after vaccine administration hives and redness began to develop on chest and quickly ascend upwards to face. Had swollen/""thickening""/tightness feeling in neck. HR 115-120, sweaty and shaking slightly. 50mg PO Benadryl administered immediately. Taken to Emergency Department where IV SoluMedrol and Pepcid were given with improvement of symptoms. Vital signs and symptoms improved by discharge from Emergency Department.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Loestrin birth control Singulair Symbicort Vitamin B12 injections Vitamin D supplements,none,Asthma Crohn's Disease,"slight flushed feeling during first dose of Covid vaccine, symptoms resolved within 1 min.",Bactrim - hives Cephalosporins - hives Shellfish - vomiting,"['Erythema', 'Hyperhidrosis', 'Muscle tightness', 'Skin hypertrophy', 'Swelling', 'Tremor', 'Urticaria']",2,PFIZER\BIONTECH,IM 924482,TN,51.0,F,Palpatations and systemic burning sensation. Lasted approx. 2 minutes then goes away; 2 episodes within 5 minutes of each other.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,"Pepcid, Diamox, vitamin B",None,"Lyme disease, PUTS, chronic increased ICP",,Topemax,"['Burning sensation', 'Palpitations']",2,PFIZER\BIONTECH,IM 924484,WA,46.0,M,Fatigue & Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,SEN,,,,,No,"['Fatigue', 'Headache']",1,PFIZER\BIONTECH,IM 924485,MO,28.0,F,"Notes vaccination at site lower than the deltoid (mid triceps area). Noticed bruising at the site, then a few days later developed redness, and itching over the area. No other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,PVT,,,,,,"['Injection site bruising', 'Injection site erythema', 'Injection site pruritus', 'Product administered at inappropriate site']",1,MODERNA,IM 924487,GA,50.0,F,swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ went down chills/fatigues soreness to injection site( which was excepted),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,None,None,None,,No Known Allegies,"['Chills', 'Fatigue', 'Injection site pain', 'Paraesthesia', 'Swelling face', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 924488,CO,29.0,F,"Several hours after receiving the vaccine I started to break out in hives and felt incredibly fatigued. Symptoms gradually improved over the next two days. Last night the vaccine injection site became hot, swollen, and incredibly itchy. Symptoms have not worsened but have not improved since taking 50mg of Benadryl at 3:30 PM today",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,"Zyrtec, Trazodone, Sertraline Hcl, women's daily vitamin",None,"Asthma, frequent sinus infections, allergies",In 2013 while living in city I received the flu vaccine and became very ill with the flu two days later. I was seen at urgent ca,Penicillin,"['Fatigue', 'Hypersensitivity', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Urticaria']",1,MODERNA,IM 924489,CA,31.0,F,Left supraclavicular lymphadenopathy with associated tenderness. Started 1 week after vaccination given.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,,,,,,"['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 924490,WV,45.0,F,"Coughing, abdominal pain, nausea, vomiting, diarrhea, headache, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,"Tramadol, B12, Benicar, Toprol xl, junel fe, lasix",Sinus infection,"High PB, tachycardia, neck injury. Bulging discs in lower back, sciatica, migrains",,"Keflex, biaxin, imitrex, zpack, macrobid, bactrim,HCTZ,","['Abdominal pain', 'Cough', 'Diarrhoea', 'Fatigue', 'Headache', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 924491,CA,50.0,M,"Welt on injection site, (left arm), redness and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PVT,none,none,none,,Aspirin,"['Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Urticaria']",1,MODERNA,IM 924492,UT,26.0,F,"I had nausea all day, heart rate over 120, pelvic & back pain, chills, normal temp of 98.6. Throughout the day my heart rate was at 125 even at sitting . My blood sugars were completely normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,UNK,"I take prenatal vitamins, novalog, 81mg asprin",No,I am diabetic,,No,"['Back pain', 'Chills', 'Nausea', 'Pelvic pain']",1,PFIZER\BIONTECH,IM 924493,OR,30.0,F,"15 weeks today, healthy pregnancy, due date is June 30th. I had a lot of arm soreness and fatigue. Felt like I could not get up or do anything.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,"Prenatal, Vit b6 and vit b3",,,,,"['Exposure during pregnancy', 'Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 924494,PR,44.0,F,Pain in the site for 2 days Swollen area for 8 days Warm to touch in injection site 7 days (12/30/2020-today).,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,Aceteminophen,No,No,,Nka,"['Injection site pain', 'Injection site warmth', 'Swelling']",1,MODERNA,IM 924495,,40.0,F,"Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing, lead to difficulty breathing and turning pale. Staff stuck me with an EpiPen in my right thigh and EMT was called and Benadryl was administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,WRK,Miralax Flonase Sumatriptan 100 mg PRN Mirena IUD Elderberry Vitamin,Steatocystoma Multiplex Migraines Allergies,Scoliosis,,Sulfa Drugs Minocycline Keppra Codeine Hazeenut,"['Chest X-ray', 'Dyspnoea', 'Laboratory test', 'Pallor', 'Palpitations', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 924496,NJ,67.0,M,"Severe muscle aches, severe headache, fever high as 100.8, chills , severe diarrhea. complete loss of appetite, fatigue weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,Benicar 20mg Daily,None,None,,None,"['Asthenia', 'Decreased appetite', 'Diarrhoea', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 924497,AR,55.0,F,"General malaise, muscle twitching, headache, joint soreness, chills, and swollen and painful lymph node under right auxiliary. Same arm as vaccine administered",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,SEN,"Synthroid, neurontin,celexa, robaxin, atorvastatin, atarax, montelukast, Prilosec, melatonin",,"Hypothyroidism, COPD, neuropathy, cad, insomnia, depression",,None,"['Arthralgia', 'Chills', 'Headache', 'Lymph node pain', 'Lymphadenopathy', 'Malaise', 'Muscle twitching']",1,MODERNA,IM 924498,TX,23.0,M,"Approximately 6 minutes after receiving vaccine, patient experiencing left arm was feeling heavy. Patient felt like the arm was feeling ""weak"". May have had some tingling in the fingers. Initial BP 137/72 HR 95 O2=97%. Heaviness in the arm dissipating after 20 minutes. At 25 minutes, patient starting feeling a dull pain in forearm ascending to the left side of the neck with some intensity, but subsiding to a very dull pain. Tingling in the fingers subsided, but very mild at 30 minutes. At 5:35pm, BP 147/75 HR 91 O2=98%. At 5:45pm patient reports some mild tingling in fingers. Pain in the neck area and arms feel more like a stiffness than pain. Patient released from clinic at 5:50pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,None,Asthma,,None,"['Limb discomfort', 'Muscular weakness', 'Musculoskeletal stiffness', 'Neck pain', 'Pain in extremity', 'Paraesthesia']",1,MODERNA,IM 924499,NY,68.0,F,"Does not have the lot#. Redness, swelling, area is very warm. This started this morning. Feels tired, under the weather. Little dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,WRK,"Lioitor, aspirin 81mg",no,hyper cholesterol,,no,"['Dizziness', 'Erythema', 'Fatigue', 'Feeling abnormal', 'Skin warm', 'Swelling']",1,MODERNA,SYR 924500,PR,66.0,F,"Bruise in the vaccination area, nine days after the vaccination inflammation, hot and reddish, under the bruise area, the effected area has continued to grow and is already large to the middle of the forearm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/04/2021,9.0,OTH,,no,"Hypertension, Thyroid",,PENICILLIN,"['Condition aggravated', 'Injection site erythema', 'Injection site haematoma', 'Vaccination site swelling', 'Vaccination site warmth']",1,MODERNA,SYR 924502,CA,30.0,M,"Patient complained of chest tightness shortly after vaccine administration. VS initially displayed tachycardia, tachypnea, and elevated BP. With controlled breathing and prone position, along with O2 the patient's VS stabilized and the chest tightness and SOB resolved. After a 90 minute observation period, he felt well enough to return home with his wife.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,WRK,,,,,NKDA,"['Blood pressure increased', 'Chest discomfort', 'Dyspnoea', 'Laboratory test', 'Tachycardia', 'Tachypnoea']",1,MODERNA,IM 924503,MI,58.0,F,LEFT SHOULDER AND NECK TIGHTNESS WITH FACIAL TINGLING AFTER LEAVING CLINIC. REFERED TO PRIVATE PHYSICIAN,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,PVT,"ASA, CALCIUM AND VIT D SUPLIMENT,TOPROL XL, PRACHOLCOL",NO,IRRITABLE BOWL SYNDROME,,"ALMONDS CARROTS, CLAMS, MORPHINE, HASZEL NUTS","['Joint stiffness', 'Muscle tightness', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 924504,TX,31.0,F,dizziness numbness and tingling down feet nausea no vomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,vit c vit d Prenatal vitamins zyrtec,none,anemia fibroids Epstein Barre virus 2019,,none,"['Dizziness', 'Hypoaesthesia', 'Nausea', 'Paraesthesia']",1,MODERNA,IM 924505,OR,35.0,F,Really bad arm soreness the first and second day the third day I had Muscle aches tiredness and fatigue.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/04/2021,2.0,PVT,Fibro synthroid Vitamin D Zoloft Prenatal vitamins,No,Thyroid disease & pregnancy,,no,"['Fatigue', 'Myalgia', 'Pain in extremity']",UNK,MODERNA,IM 924506,CA,64.0,F,Experienced moderate headache and associated nausea 15 minutes after vaccination. Symtpom resolved in 30 minutes wuth acetaminophen and Compazine 5 mg orally x1,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,No,No,No,,"Sulfa, tetanus, gadolineum","['Headache', 'Nausea']",1,MODERNA,IM 924507,WI,18.0,F,Time course: Received Pfizer COVID vaccine 1515. Had immediate reaction. See next page.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,sertraline 25mg po daily; Alesse 1 tab po daily,none documented,,,NKDA,"['Asthenia', 'Cold sweat', 'Dizziness', 'Electrocardiogram normal', 'Feeling abnormal', 'Feeling jittery', 'Hyperventilation', 'Immediate post-injection reaction', 'Mobility decreased', 'Nausea', 'Palpitations', 'Retching', 'Tremor', 'Vomiting']",1,PFIZER\BIONTECH,IM 924508,CA,44.0,F,"15 minutes after the injection, I got some itching on my right shoulder near the injection site. I waited around a bit longer and the itching and heat started to grow down my arm and across my chest and back. I was asked to go to the ER as it was not resolving. At about one hour, I started to get some mild chest pain, My BP was 173/101 and around 100+ for heart rate. O2 was 100% . ER staff did an EKG. The ER DR gave me Pepcid, Benadryl and Prednisone and 1 liter of normal saline. I was observed for about 3 hours. I went home and was feeling much better. The next 3 days I had a moderate headache and sore arm. I took Tylenol. I had some hot flushes and mild spikes of temperatures 100-101F, through the next couple of days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"METFORMIN, Armour Thyroid 30 MG, Metoprolol Succinate ER 25 mG, Vyvanse 30 MG , LEVOTHYROXINE 75MCG, VITAMIN B COMPLEX, VITAMIN C, VIT D3, ASHWAGANHDA125MG, BERBERINE SUPPLEMENT, benaGene stabilized oxaloacetate supplement, Heme Iron, As","COVID exposure with symptoms around Nov 23, 2020, NEG Covid and antibody test,","Hypothyroid, ADD, endometriosis, insulin resistance, gallbladder stones, chronic kidney stones, UTIs,","Tdap Red, hot large wheel and blisters around site and PPD red, hot large wheel","Iodine contrast, Demerol, macrobid, Omnicef, Ingested Arnica, whey and gluten sensitivity","['Body temperature increased', 'Chest pain', 'Electrocardiogram', 'Feeling hot', 'Headache', 'Hot flush', 'Injection site pruritus', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 924509,MI,23.0,M,"Pt was tachycardic, felt heaviness, and was sore in left arm with shot. Patient was laid supine and observed for 30 minutes. He drank 3 bottles of water and felt much better. He was able to leave the clinic on his own and advised to seek medical attention if symptoms returned or worsened.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Discomfort', 'Pain in extremity', 'Tachycardia']",2,PFIZER\BIONTECH,IM 924510,CA,52.0,F,"Right shoulder (injection site), right back, HA 12/24/20-12/27/20. Right-sided back tingling on starting 12/24/20. Fatigue and chills 12/28/20. Occasional right back tingling resolved 12/31/20.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,"Lisinopril, Lovastatin, Amlodipine, Zyrtec",n/a.,"hypertension, high cholesterol",,"Azithromycin, sensitive to cleaning solutions (like Clorox), smoke, injectable contrast dye (doesn?t remember name).","['Chills', 'Fatigue', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 924511,ME,38.0,F,1/6/21 (7 days after injection) developed itchy induration to left shoulder at injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,PVT,Daysee (oral contraceptive - levonorgestrel-ethinyl estradiol) levothyroxine omega 3 prenatal vitamin calcium,none,hypothyroid (Hashimoto's) irritable bowel depression frequent UTi,,none known,"['Injection site induration', 'Injection site pruritus']",1,MODERNA,IM 924512,FL,50.0,M,"Moderate LUE pain, back ache, head ache, appetite loss",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Trazadone 12.5 mg, valerian root extraxt",Na,,,"Fish, chicken, turkey, avocado, banana","['Back pain', 'Decreased appetite', 'Headache', 'Pain in extremity']",1,MODERNA, 924513,AZ,29.0,F,"I had patient report that she had localized swelling and lymphadenopathy. I confirmed this on physical exam. She had localized increased warmth over the left upper outer arm where the vaccine was given at the deltoid. There was a raised area of skin in a serpiginous pattern circumferentially 3.5 across and 4.5cm in length. It was blanching and not firm. She had 1 soft lymph node palpable at the left axilla, tender and 1.5cm in size. She has had no other symptoms other than pain at the injection site for 2 immediately days after the injection was given. I advised that she fill out the information for v-safe and asked that she report any further program to both v-safe and our office.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,09/09/2020,09/09/2020,0.0,WRK,,,,,,"['Injection site pain', 'Injection site warmth', 'Lymph node pain', 'Lymph node palpable', 'Lymphadenopathy', 'Pallor', 'Swelling']",1,MODERNA,IM 924514,WI,30.0,F,"8am on 12/31/20 she got fever of 100.2 degrees F and body aches and dry throat. Hives at 6PM the same night on r arm and r temple. Took benadryl x1 dose and hives went away. Also took some claritin. Low grade temp, body aches and dry throat lasted until the evening of 1/1/2021. She did not see any healthcare professional other than covid testing on 1/4/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,depo shot,No,no,,penicillin & bactrim,"['Dry throat', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Urticaria']",1,MODERNA,IM 924515,CA,64.0,F,Headache associated with nausea and chills approximated 15 minutes after vaccination. Symptoms resolved after 30 minutes with acetaminophen and Compazine 5 mg orally once,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,NO,No,No,,"sulfa, tetanus, gadolineum","['Chills', 'Headache', 'Nausea']",1,MODERNA,IM 924516,CA,61.0,M,"Redness, heat 4 inch circle, warm you can feel through the clothing.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,"turmeric, antacid",no,no,,"no, hayfever","['Erythema', 'Skin warm']",1,MODERNA,SYR 924517,CA,43.0,F,"Lip and nose tingling, lip swelling, metallic test in mouth Sent to the ED for 2 hours given Dexamethasone and Benadryl . Symptoms resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,PVT,Multi Vitamins,None,None,,None,"['Dysgeusia', 'Lip swelling', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 924518,NC,28.0,F,Enlarged and tender supraclavicular lymph node on left side.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,UNK,Singular Pro air HFA Flovent HFA Effexor Xyzal Zinc Vitamin D Vitamin C Probiotic,None,Asthma Allergies Eczema Anxiety,,"Allergy to mold, trees, weeds, cats, horses","['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 924519,OR,58.0,F,"6 minutes after receiving the injection the patient became dizzy complaining of rotatory vertigo and complained of increased thirst. She was placed on a stretcher in the observation area and given 3 glasses of water 09:45. She complained of light sensitivity and a cloth was placed over her eyes. SaO2 98% HR 63 BP 150/82 RR 18 CBG 95. when after a few minutes she did not feel better. IV access was obtained and she was given a 1 L bolus of LR. after an hour she felt better, and was sent home with family for the rest of the day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Blood glucose normal', 'Dizziness', 'Photophobia', 'Thirst', 'Vertigo']",UNK,MODERNA,IM 924520,MA,30.0,F,"1st vaccine 12/28/2020. 1/5/2021 new onset of rash from the shoulder halfway down toward elbow. slightly itchy but not painful or tender to touch. no raised bumps. just redness. this was at the injection site, same arm same area though first noticed 1/5/2021 not immediately after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,WRK,"Birth Control, fiber",,,,Bactrim,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 924521,IN,39.0,F,"Myalgias, chills, nausea/vomiting, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,Alesse Celexa Multivitamin,None,None,,PCN,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 924522,MI,51.0,F,"COUGH, TOUNGE TINGLING , SCRATCHY THROAT 15 MIN POST VACCINE. EPI AND BENADRLY GIVEN IN CLINIC EMERGENCY DEPT GAVE DECADRON",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/23/2020,,PVT,"XANAX, NORVASC, WELBUTRIN,ZYRTEC, FLEXERIL, VIT D, FLONASE,,STNTHROID",NO,ASTHMA,,"FENTAYL, PENICILLIAN, HYDROMORPHONE,","['Cough', 'Paraesthesia oral', 'Throat irritation']",1,PFIZER\BIONTECH,IM 924523,NY,41.0,F,"Red blotchy rash over chest and around neck. Felt warm, but not itchy or painful. Had a telehealth visit with my PA due to never having a reaction to a vaccine before other than a sore arm at site. He prescribed Benadryl. The rash started within a few hours after being vaccinated. Rash lasted 4-5 hours. The time frame is estimated for both onset and duration as I was working and not near a mirror.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,Not disclosing,,,,Ramipril ----Causes a cough,"['Feeling hot', 'Rash', 'Rash erythematous', 'Rash macular']",1,MODERNA,IM 924524,MN,31.0,F,"PATIENT REPORTING ITCHING AT 30 MINUTES POST INJECTION. AT 1.5 HOURS POST INJECTION PATIENT REPORTED ITCHY THROAT AND NUMBESS OF LEFT SIDE OF FACE. AT THAT TIME ADVISED TO GO TO EMERGENCY ROOM. NEXT DAY WHEN I FOLLOWED UP WITH PATIENT, SHE REPORTED HER AIRWAY STARTED TO CLOSE AND SHE RECEIVED EPINEPHRINE, AFTER 5 HOURS HER STARTED TO CLOSE AGAIN AND RECEIVED ANOTHER DOSE OF EPINEPHERINE, WAS RELEASED FROM HOSPITAL ROUGHLY 15-16 HOURS AFTER GOING TO ER.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/05/2021,01/05/2021,0.0,PHM,UNKNOWN,UNKNOWN,UNKNOWN,"ANAPHYLAXIS TO INFLUENZA VACCINE, UNKNOWN DATE",ANAPHYLAXIS TO INFLUENZA VACCINES,"['Hypoaesthesia', 'Obstructive airways disorder', 'Pruritus', 'Throat irritation']",1,MODERNA,IM 924525,FL,39.0,F,"Patient complained of tingling and numbness in left arm at completion of the 15 minute observation time. Neuro-Vascular assessment was performed by and was found to be within normal limits. Capillary refill was brisk, skin was dry and warm to touch, no localized reaction was observed at the injection site, bilateral grip was of equal strength and quality. Observation period was extended for an addition 15 minutes, with no worsening of symptoms. Patient was offered follow up examination and medical care at the in-house Urgent Care, which the patient denied any further medical treatment at that time. Patient advised to continue to monitor for neurological changes, loss of mobility or sensation, signs and symptoms of anaphylaxis and if experiencing worsening symptoms, to seek immediate emergency medical care.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,None Reported,None Reported,None Reported,,Percocet Latex,"['General physical condition normal', 'Hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 924528,IN,61.0,F,"dizzyness within minutes. was told by nurse onsite this was not an adverse reaction. the paperwork they gave stated otherwise. after about 30-40 mins the dizzyness subsided. no treatment. chest pain. not sure if heart or lungs. was not due to eating as symptom was steadily getting worse across 3 days whether I ate or not. was difficult to eat due to the pain. didnt matter if was sitting, standing or laying down. felt like saran wrap around my heart...sqeezing it...with pain. pain stayed centered in chest. behind sternum. still there, but tonight does seem a little better. was not intermittetent but was more pain sometimes and less pain sometimes. longterm outcomes unkn.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,UNK,shark liver oil,none,none,,"penicillin, latex, nsaids, morphine, bananas, cats, artificial sweeteners, herbicides/pesticides, corn/corn products, oxycodone","['Chest discomfort', 'Chest pain', 'Dizziness']",UNK,PFIZER\BIONTECH,IM 924531,ID,19.0,F,"Hives, closing of throat, sweeling of tounge, swollen hands, itchy eyes",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PHM,,No,,,Omnicef and sulfa,"['Eye pruritus', 'Oropharyngeal discomfort', 'Peripheral swelling', 'Swollen tongue', 'Urticaria']",1,PFIZER\BIONTECH,SYR 924532,FL,59.0,F,sore spot small lump with red area around vaccine spot and etching,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Omeprazole ,collagen, B complex vitamin D Bupropion",headhish before baccine,none,,penicillin,"['Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,SYR 924533,CA,30.0,F,"Heart rate was high, felt nauseous, light-headed on and off. BP was high for two after it was given. Took Bendaryl two hours after and heart rate slowly went down to normal. Headache and Sore throat, a little difficult to swallow.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,none,none,none,,Ceclor,"['Dizziness', 'Dysphagia', 'Headache', 'Heart rate increased', 'Hypertension', 'Nausea', 'Oropharyngeal pain']",1,MODERNA,SYR 924534,CA,29.0,F,Received the vaccine on 12/31/2020. Symptoms: -Soreness developed later on in the evening and remained very sore and tender for a couple days. -A light headache occurred and went away within a few hours. - After 5 days on of having the vaccine on 1/05/2021 I developed a itching sensation on my arm And developed a rash on my arm (deltoid) where the vaccine was administered. It is a square shaped rash on my left arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,PVT,Minocycline for the past 2 months,No Illnesses,No chronic or long standing health conditions,,No know. allergies,"['Headache', 'Injection site rash', 'Pain', 'Pruritus', 'Tenderness']",1,MODERNA,SYR 924535,NY,28.0,F,Hives on neck 8 hours later,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,Generess FE,None,None,,No,['Urticaria'],1,MODERNA,IM 924536,VA,81.0,F,"On Tuesday, Jan 5 pm swelling four by six inches on upper right arm very red hot area . Area still the same at 7:30 pm on January 6.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/06/2021,3.0,SEN,,,Low blood count,,"sulfa, pencillin","['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",UNK,PFIZER\BIONTECH,SYR 924537,AL,49.0,F,"bp 100/54 synocopalepisode; experienced nausea, was anxious prior to injection; states this has happened with another injection in past. is now awake, alert and oriented; 911 called-evaluated by ems; refused transport; observed an additional15 min. s/s resolved; denies sob, rash, edema, etc.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Anxiety', 'Nausea', 'Syncope']",1,PFIZER\BIONTECH,IM 924538,MI,38.0,F,FELT WARM SCRATCHY THROAT. OBSERVED,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,SYNTHROID,NO,HYPOTHYROIDISM,,"CIPRO , STADOL",['Throat irritation'],1,PFIZER\BIONTECH,IM 924539,CA,40.0,F,"At 10:12 am, Client c/o of sore throat, tightness in throat that relieve quickly, nausea, dry heaves, flushed, light headed and dizziness. Called for EMT. They arrive at 10:25 am and transported her to the local hospital for observation. 01/06/21-Treatment in hospital blood draw, medications given Zofran, Decadron, Benadryl, and Pepcid, and IV fluids. Discharged home at 1244.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,"Albuterol Inhaler, Nortriptyline, baclofen",none,"osteio arthritis, joint hyper mobility, chronic migrans, fibromyalgia, IBS,",,"Penicillin and mushrooms, and nsaid.","['Blood test', 'Dizziness', 'Flushing', 'Nausea', 'Oropharyngeal pain', 'Retching', 'Throat tightness']",UNK,MODERNA,IM 924540,NM,55.0,F,she had sores in her mouth start and to throat,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/06/2021,2.0,OTH,"multivitamin, magnesium","pneumonia from Dec 2 to 29th, 2020.",none,,"ASA, PCN, Codiene","['Oropharyngeal pain', 'Stomatitis']",1,MODERNA,IM 924541,WV,61.0,F,"Diarrhea, near syncope, extreme fatigue. Started 30 hours post injection & continued x 48 hours. Site soreness/edema 24 hours after injection that increased to extreme sensitivity at site after 30 hours which lasted 24 hours. Left deltoid swollen x 1/2 more than usual size started 36 hours after injection and lasted 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,"Melatonin Restoril Benadryl Vitamin D3 10,000 IU/week",None,Recovered from spinal injury.,,"PCN, Penicillin derivatives, Erythromycin, Bactrim, latex","['Diarrhoea', 'Fatigue', 'Injection site hypersensitivity', 'Injection site oedema', 'Injection site pain', 'Injection site swelling', 'Presyncope']",1,MODERNA,IM 924542,KY,41.0,F,"Dizziness, fever, chills, body aches, severe headache. Taken Tylenol and ibuprofen for fever and pain for 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"Vit D3, Vit B12, multivitamins, Vit C, Magnesium, Zinc",none,none,,NKA,"['Chills', 'Dizziness', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 924543,IN,44.0,F,"Cold chills,body aches and major headache that lasted about 12 hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,None,None,None,,Reglan,"['Chills', 'Headache', 'Pain']",1,PFIZER\BIONTECH,SYR 924544,IN,22.0,F,"The next day, I had a fever of 100, body aches, sore shoulder, and headaches after getting the vaccine. It's been two days already, and I'm still down with a fever, bad headaches, dizziness, and a sore shoulder - I put ice pack, which didn't really work. Whenever I stand, I feel like I'm gonna pass out. I've been in bed for the past two days, and I can't work.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,No,No,No,,"Green chilies, Mushroom, Bell Peppers, Jalapenos, Olives","['Arthralgia', 'Dizziness', 'Dizziness postural', 'Headache', 'Impaired work ability', 'Mobility decreased', 'Pain', 'Pyrexia']",1,MODERNA,SYR 924545,MA,49.0,F,"Fever (101F), body aches, joint pain, headache, left upper abdominal pain (under base of ribs) all lasting apx 16hrs. Then the next 24 hrs just mild HA and some body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Qysmia,None,None,,No,"['Abdominal pain upper', 'Arthralgia', 'Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 924546,SD,34.0,F,"My arm started out sore with redness at the injection site, it decreased after a few days. Then the redness came back bigger in size than it was previously. My axilla started having pain, that pain is consistent and doesn?t subside with any intervention. The pain seems to be increasing by the day. I have not sought evaluation on this, hoping it will go away soon.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,UNK,Prozac Wellbutrin Trazodone Multivitamin,,Depression,,Sulfa Drugs,"['Axillary pain', 'Injection site erythema', 'Injection site pain']",1,MODERNA,IM 924547,,35.0,F,"Noted had history of various allergies. Received vaccine at 6:06 pm and about 10 minutes later noted headache. BP 150/70; p 86. Then neck pain, bilateral leg soreness, and hip pain; R foot tingling, felt warm, itching, no rash noted. Treated with 25mg benadryl at 0624 pm; BP 130/82. And went to ED for evaluation via wheelchair/personnel.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Feeling hot', 'Headache', 'Neck pain', 'Pain in extremity', 'Paraesthesia', 'Pruritus']",1,PFIZER\BIONTECH, 924548,IL,28.0,M,"Adverse Reactions: Chills, Nausea, Low Grade Fever (100.5-100.6), Lethargy, muscle pain Treatment: Ibuprofen 200mg: 4 tabs (800 mg) taken once for single dose Outcome: Fever lowered, however, lethargy remained all day. The next morning (12/31/2020) I felt completely fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,,,,"Same as described before, Flu vaccine - back around 2015",Penicillin,"['Chills', 'Lethargy', 'Myalgia', 'Nausea', 'Pyrexia']",UNK,MODERNA, 924549,OR,52.0,F,"On 1/5/2021- Pt. noticed left eye lid was starting to swell in the corner of her eye at 1 pm. It then became bigger and started to shut her eye. Her right eye then started to swell around 2 pm and she began to have difficulty talking and swallowing. She was not short of breath but felt like her throat was tightening. She arrived to work at 2:50 pm and informed her boss who sent her to the employee health department. She reported having oral Benadryl and was going to take that. Anesthesiology evaluated her, felt it was a progressive allergic reaction, and recommended evaluation at an urgent care or ED. She later developed hives, her lower lip became swollen. She was later evaluated at Emergency Department. She will be able to provide you with information on the doctor, treatment. She was prescribed a course of prednisone and will have allergy testing scheduled. MD indicated uncertain if caused by vaccine. She missed work on 1/6 due to the ongoing reaction which had improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,PVT,Patient has recent history of breast cancer and treatment. We are not her PCP or oncologist so we do not have a complete medical history.,No other reported illnesses.,See history of breast CA. Uncertain of other medical history since not PCP.,,She states she never had any allergies or allergic reactions until this year following cancer chemotherapy treatments.,"['Blood test', 'Dysphagia', 'Eye swelling', 'Hypersensitivity', 'Impaired work ability', 'Lip swelling', 'Swelling of eyelid', 'Throat tightness', 'Urticaria']",1,MODERNA,IM 924550,WI,58.0,M,"Patient reported a fever and tingling to his face in the morning on 12/17/20. EHS followed up with him at 11:30 am on 12/17. He reported that the fever had resolved, and he was no longer having tingling to his face. He denied paralysis to his face, shortness of breath, and chest pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/17/2020,1.0,PVT,,,,,No known allergies,"['Paraesthesia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 924551,NE,47.0,F,"Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon. Patient states that she received her second Covid vaccination yesterday and began developing symptoms today. States she had a temperature of 102. She is a nurse here in the rehabilitation center. She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools. She has had no urinary symptoms. She denies any leg swelling or pain. No history of DVT or pulmonary embolism. No recent travel, immobilizations, surgeries, bedrest or history of malignancy. No hemoptysis. Again, no cough. Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history - Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen. Symptoms are consistent with side effects of the Covid vaccine. She does not appear ill appearing. She has no fever at this time. She does state that her symptoms are somewhat improved. Chest x-ray and labs are otherwise unremarkable. Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen. This is the patient's second dose of vaccine for Covid.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,MECLIZINE 25mg PO TID PRN dizziness,,,See item 18,"cephalosporins, indomethacin, ketoprofen, penicillins","['Blood glucose increased', 'Blood potassium decreased', 'Body temperature increased', 'Cardiac monitoring', 'Chest X-ray normal', 'Electrocardiogram normal', 'Heart rate increased', 'Pain', 'Pyrexia', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 924552,,40.0,F,body aches and sore arm. body aches started up on the 6th of January. Headache as well and a cough.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,UNK,,,,,,"['Cough', 'Headache', 'Pain', 'Pain in extremity']",1,MODERNA,SYR 924553,WA,23.0,F,"Started 45 minutes after, feeling faint and fatigued. Next morning feeling generalized pain fatigue later in the day had a temp and feeling chills as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Viibryd Levothyroxine Wellbutrin Enskyce Liothyronine,,Hypothyroidism,,NKDA,"['Body temperature abnormal', 'Chills', 'Dizziness', 'Fatigue', 'Pain']",2,PFIZER\BIONTECH,IM 924554,CA,38.0,F,Numbness and tingling on the injection site and the left side of your face. Also reports a metallic taste in her mouth,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,"Motrin, as well as regular medications",,,,,"['Dysgeusia', 'Hypoaesthesia', 'Injection site hypoaesthesia', 'Injection site paraesthesia', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 924555,TX,53.0,F,Tested positive for COVID on 01/06/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/06/2021,10.0,PVT,Amlodipine 5 mg daily Celebrex 50 mg daily Pantroprozole 40mg daily DiviGel 1% daily,Localized Scleroderma Raynaud's disease HTN,Localized Scleroderma Raynaud's disease,,PCN,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 924556,NY,35.0,F,"Heart racing 120 bpm, felt numbness on left side, lasted about 5 minutes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,Vitamin C Multivitamin Magnesium,Denies,Seizures Brain and breast tumor,,Penicillin Codeine Mushroom,"['Hypoaesthesia', 'Palpitations']",1,MODERNA,IM 924557,TX,22.0,F,"a day after receiving the vaccine, she felt some soreness to injection site and arm, unable to raise arm up; felt achy, fatigued then at the end of the day, noticed fever, temperature going up from 97 to 99 to100, then as high as 101 F over a 4 hour time frame; she took ibuprofen 400mg that night then awoke this morning feeling better; she has not taken any more fever reducing medications and has no fever today even though her arm is still sore, she can move it more now and just sore to touch",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,WRK,Metronidazole 500 mg 1 PO BID x 7 days (on 5th day),infection,unknown,,Unknown,"['Fatigue', 'Injection site pain', 'Mobility decreased', 'Pain', 'Pyrexia', 'Tenderness']",1,MODERNA,IM 924558,CA,43.0,F,"Patient presented for Moderna COVID vaccine and was asked to wait 15 min post vaccine for monitoring. Patient presented with numbness, tingling sensation in the neck and left wrist pain with weakness including 4th and 5th digit. Injection was administered in opposite arm (right). Tingling sensation then escalated to whole body with nausea and dizziness. BP reading was 149/78 and 160/74 with 15 min intervals. EMS was contacted at 1355 to transport patient to the ED. Numbness and tingling in the knee, unable to use left hand to text and left side whole body. Patient is able to elevate both arms at same level. EMS arrived at 1408 and transported patient to the ED at 1411",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Dizziness', 'Hypoaesthesia', 'Mobility decreased', 'Nausea', 'Paraesthesia']",1,MODERNA,IM 924559,IN,28.0,F,"On January 6, the area around the injection site started itching. I then noticed it was more tender. The area is now red, raised, swollen, tight and warm. The area is about the size of a deck of cards. I have now taken 50mg of diphenhydramine PO and 1000mg of Tylenol PO.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"Sertraline 100mg daily, Women?s Daily Multivitamin",None,Depression,,None,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Skin tightness']",1,MODERNA,IM 924560,OH,37.0,F,Broke out with pimples all over body,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,01/05/2021,12.0,PVT,Vitamin d vitamin B Multivitamin,None,None,,Penicillin,['Acne'],1,MODERNA, 924561,MN,34.0,F,"Fever up to 102 accompanied by headache, fatigue and significant body aches. Onset of severe symptoms about 12.5 hours after administration, treated with Tylenol (1gm q6H) and ibuprofen 600mg q6H alternating. Fever initially unresponsive to antipyretic. 24 hours post-administration has decreased to 99.4.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,WRK,None,None,None,,Latex,"['Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924562,NY,36.0,F,"Approximately 7 minutes after the vaccination was given, my face became red and flushed and I experienced a sensation of heat in my body. I recieved additional monitoring by staff and felt better approximately 20 minutes later",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Wellbutrin 300xl,None,Low platelets,"Age 14, fainting after first dose of hepatitis b vaccine",None,"['Erythema', 'Feeling hot', 'Flushing']",1,MODERNA,IM 924564,MA,28.0,F,"I received my first dose of the Moderna COVID-19 vaccine on 12/29/2020 and to date, have had mild symptoms, which I have reported via the V Safe Check Ins. To date, I experienced some injection site soreness with redness for a few days post vaccine and had minimal swelling on the day after vaccination. This evening, I noticed a sudden onset of severe swelling at the site of the injection accompanied with redness, which as noted above, had previously resolved approximately 3 days post vaccination. In addition, the area surrounding the injection site is now warm to the touch and is mildly itchy. In taking the temperature of the injection site versus the rest of the arm, it is running about 3 degrees warmer than the rest of my arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,WRK,None,No known other illnesses at time of vaccination and up to one month prior,None,,No know allergies,"['Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 924565,CO,44.0,F,"Swelling, redness and pain at injection site. Parameters of inflammation marked to monitor for worsening. Still monitoring have not had to seek medical attention yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,WRK,"Zyrtec, Omeprazole, Lisinipril, Buproprion, Premarin, prednisone","COVID positive on 11/17/2020,","Asthma, HTN, GERD",,Seafood,"['Injection site erythema', 'Injection site inflammation', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 924566,CO,25.0,F,"My left arm began to swell around the site where I got the vaccine. It became very warm, bright red, and felt hard to the touch. It was also incredibly painful, such as when my shirt was just resting on it, as shirts do. This lasted for 2 days and it still has some redness and sensitivity. The joints on my hands and wrist also became swollen and incredibly sore, and this has still not gone away.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/03/2021,8.0,PVT,Venlafaxine 37.5 mg Modafinil 200 mg 2x/day Xyrem 9 grams/night Sunosi 150 mg Ropinirole 0.25 mg Gabapentin 300 mg Iron supplement B12 vitamin OTC generic allergy pill,None,Narcolepsy Scoliosis,,None,"['Arthralgia', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Joint swelling']",1,MODERNA,SYR 924567,NV,21.0,F,"Client felt dizzy, mouth and upper throat went numb, chest tight, shakey, felt terrible. Seeing double and nauseated. went to ER and received IV benadryl and relieved many symptoms but had heart rate escalating and dizzy continuously. Body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,Denies,Denies,Denies,,Denies,"['Blood test normal', 'Chest discomfort', 'Diplopia', 'Dizziness', 'Electrocardiogram normal', 'Feeling abnormal', 'Heart rate increased', 'Hypoaesthesia oral', 'Nausea', 'Pain', 'Pharyngeal hypoaesthesia', 'Tremor']",1,MODERNA,IM 924568,NY,58.0,F,"Approximately 8 days after receiving the Moderna injection, I had a reaction in my upper arm (left arm-the one I received the vaccination in). My upper arm broke out in what looked like a bright red rash in the area of the injection. The first thing that happened was it started itching, so I scratched it, then realized the area was very warm, so I looked and noticed the bright red color of it. Also, at the same time, the area felt almost bruised when I scratched, but it wasn't bruised to look at, maybe under the skin it was bruised? It got to be about 4 inches by 2-3 inches and then within a couple days, it went away. I did put hydrocortisone cream on it off and on. As an interesting aside---when I had the first dose of Shingrix I broke out with a rash below the area where they gave me the vaccination. This rash happened within a day or so of the vaccine, whereas with the Moderna, it was a tad more than a week later. This was also my left arm. With Shingrix though, it was a bit larger and raised up a bit. That only lasted for a few days also. I don't remember which arm I had the second Shingrix vaccine in, but I do not remember any adverse reaction after receiving it.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/30/2020,8.0,PVT,"Metoprolol, levothyroxine, pravastatin, ibuprofen",None,"Migraines, BPPV, arthritis in feet and knees.","Only a rash in the arm where I received the Shingrix vaccine, which I explained earlier in this report.",None known of.,"['Feeling hot', 'Injection site bruising', 'Injection site rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,SYR 924569,NH,38.0,F,Shoulder bursitis pain immobility,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PUB,"Metoprolol , lipitor",None,Htn,,None,"['Arthralgia', 'Bursitis', 'Mobility decreased']",UNK,MODERNA,IM 924570,MO,48.0,F,Itching,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,1) alprazolam 0.25mg TID; 2) aspirin 325 mg daily; 3) dicyclomine 20 mg QID; 4) dicyclomine 10 mg PRN TID; 5) Farxiga 5mg daily; 6) ketoconazole 2% topical cream daily to affected area; 7) Lipitor 10 mg daily; 8) Novolog Flezpen U-100 Insu,DM,1) Type 2 DM; 2) Major Depression 3) Obstructive sleep apnea 4) Essential hypertension 5) HTN 6) Atrial tachycardia 7) Gastritis 8) Fibromyalgia 9) Syncopal vertigo 10)Syncope symptom 11) Dyspnea 12) abdominal pain syndrome,Itching with other past vaccinations,1) adhesive; 2) ativan; 3) Cipro; 4) Coconut; 5) Dilaudid; 6) Erythromycin; 7) Fluorescein; 8) Mastisol adhesive; 9) Morphine; 10)Stadol ; 11) Toradol,['Pruritus'],1,PFIZER\BIONTECH,IM 924571,WI,40.0,F,"The first 2 days after the shot my arm was sore. That went away and then on 1/5/21 my arm became sore, red, raised and warm around the injection site. It still is 1/6/21 along with body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,Sertraline buspirone claritin tylenol lisinopril Allergy drops prescribed by an allergist,Cold symptoms 1 week before with 2 negative covid tests,Hypertension anxiety depression Seasonal allergies,Red raised area around the site after some of my yearly flu shots. Within 1 day,Compazine Seasonal,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Pain in extremity']",1,MODERNA,IM 924572,CA,32.0,F,During post vaccination monitoring pt began to complain of tingling in her throat and palpitations. Was sent from chair to gurney. At that time was evaluated. Symptoms included elevated BP and HR. 911 called at 1304 and pt sent to ED,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Blood pressure increased', 'Heart rate increased', 'Palpitations', 'Pharyngeal paraesthesia']",1,MODERNA,IM 924573,MO,61.0,M,"LOW GRADE FEVER, 99.9, MILD BODY ACHES, MILD MALAISE LASTED ABOUT 24 HOURS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,"LISINOPRIL, PROTONIX, ASPIRIN, OMEGA-3 OIL, ATORVASTATIN",URI,"HTN, HYPERLIPIDEMIA",,,"['Malaise', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 924574,TX,44.0,F,1 week after I felt welts on my arm around the injection site that we're itchy. I took Benadryl and applied an ice pack. The next day where the welts were my arm is now red and warm feeling.; Slightly itchy. My arm has felt heavy like a swollen feeling although not swollen - as if my arm was asleep.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PHM,Birth control pill. Brand name Nortel.,None,None,,Seasonal allergies - Cedar,"['Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Injection site warmth', 'Limb discomfort', 'Swelling', 'Urticaria']",1,MODERNA, 924575,CA,45.0,F,Had a flushed feeling across her chest no shortness of breath or rash noted . Was given 50 mg Benadryl watched for another 30 minutes no other issues. Stable and is feeling fine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,"C, d and Zinc Monocycline . probiotic",None,None,,Allergy to PCN,['Flushing'],1,MODERNA,IM 924576,MA,53.0,M,"Fairly rapid onset of excess fatigue, difficulty keeping eyes open associated with oscillating vision, near simultaneous distortion of sound (at the time was watching a show using my phone, and the actors no longer sounded like themselves), sense of subtle disequilibrium, and a sense of intense heat involving my upper abdomen and lower chest, centered around my xiphoid process as if being pressed up against a space heater, the latter symptom was non-painful, perhaps the best example is the feeling one has after receiving intravenous contrast dye for CT imaging although more the ""warmth"" was more intense. Lasted 90-120 minutes before going to sleep, then gone by morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,Aspirin 81 mg daily. Multivitamin one tablet daily. Vitamin B12 1000 mcg daily. Vitamin B complex one tablet daily. Vitamin D3 2000 units daily. Olmesartan 40 mg daily. Lamotrigine 150 mg QAM and 300 mg QHS. Rosuvastatin 10 mg QHS. Cetiri,None.,Seasonal allergies. Essential hypertension. Seizure disorder.,,Penicillin as child but reaction unknown.,"['Balance disorder', 'Fatigue', 'Feeling hot', 'Illusion', 'Somnolence', 'Visual impairment']",1,PFIZER\BIONTECH,IM 924577,WA,9.0,M,"Patient was admitted to the hospital, critically ill and intubated in the ICU with encephalomyelitis consistent with acute disseminated encephalomyelitis (ADEM) associated with MOG-IgG positivity (or MOGAD). Course complicated by respiratory failure, paroxysmal sympathetic hyperactivity, optic neuritis, staph aureus tracheitis requiring antibiotics and ongoing encephalopathy. - underwent thorough infectious work up, multiple MRIs, lumbar puncture and brain biopsy - underwent several days of electroencephalogram (EEG) - Received 5 days IV methyl prednisone followed by a slow taper - Received 6 days of plasma exchange or PLEX - Received IVIg 2mg/kg (and will received monthly IVIg for 6 months)",Not Reported,,Not Reported,Yes,,Not Reported,N,09/24/2000,11/04/2020,7346.0,PVT,,none.,none.,,No known allergies,"['Acute disseminated encephalomyelitis', 'Bacterial tracheitis', 'Biopsy brain', 'CSF test', 'Central nervous system inflammation', 'Critical illness', 'Cytogenetic analysis', 'Electroencephalogram', 'Encephalomyelitis', 'Encephalopathy', 'Endotracheal intubation', 'Immunoglobulin therapy', 'Intensive care', 'Lumbar puncture', 'Magnetic resonance imaging', 'Optic neuritis', 'Paroxysmal sympathetic hyperactivity', 'Plasmapheresis', 'Respiratory failure']",,SANOFI PASTEUR,IM 924578,MA,68.0,F,"Moderna vaccine EUA within 4 minutes i began to feel faint, heart started pounding ,immediate headache and was very shaky. I was laid down, cold compress. It came in waves over a period of 20 minutes. I was given a few sips of water. When it did not resolve I was taken to the ER and given IV fluids. The doctor said I had an adverse reaction to something in the vaccine. The chief of Infectious disease thought I had a vaso vagel response. While I am nervous to get the second vaccine , I will go forward and get it..",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/01/2021,,PVT,"furosemide, metformin, omeprazole, amlodipine. loratadine",none,"diabetes, high blood pressure gastric reflux",,"penicillin, erythromycin CT contrast dye, shellfish,","['Dizziness', 'Electrocardiogram abnormal', 'Headache', 'Nervousness', 'Palpitations', 'Presyncope', 'Tachycardia', 'Tremor']",1,MODERNA,IM 924579,MA,52.0,F,"Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated pupils), loss of BP, rapid heart rate, uncontrollable rigors/trembling. Rushed down hall to ED via stretcher. Received IV fluids, IV steroids, IV benedryl, IV pepcid, IV ativan.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/20/2020,0.0,PVT,Pepcid,Not that I know of,History of controlled SVT (supraventricular tachycardia),,Flu Vaccine circa 2013/2014 Had a flu vaccine in 2020 w/out incidence,"['Atrial tachycardia', 'Blood pressure decreased', 'Chills', 'Confusional state', 'Dizziness', 'Electrocardiogram abnormal', 'Heart rate increased', 'Hypoaesthesia', 'Immediate post-injection reaction', 'Mydriasis', 'Paraesthesia', 'Tremor']",1,PFIZER\BIONTECH,IM 924580,FL,21.0,F,"1/5/21-About an hour after receiving vaccine, I had mild nausea, my left arm kind of hurt after receiving the vaccine.. which is weird because I got it in my right arm. 1/5/21- Around 8:00 PM I noticed raised red bumps on both of my forearms.. it?s worse on the right arm. It looked like a mild rash. Around 10:00 PM I developed chills, muscle aches, my right arm was in a lot of pain, I had a slight headache, nausea, and my temperature kept going up. I?ve been taking Advil/ Tylenol to try and get my temperature down.. but after every dose wears off my temp goes back up. I kept waking up multiple times in the middle of the night. In the middle of the night around 2AM, my temperature was as high as 102.9. Later on in the night around 4AM, my chills had stopped and I actually felt really warm. 1/6/21- I woke up about 6:30 AM and had to call out of work. My temp was about 98 something at this point and I still had muscle aches. I slept most of the day and my temp continues to go over 100 now every time a dose of Advil wears off. I still have muscle aches and there is still a lot of pain at the injection site. My arm doesn?t hurt as bed as it did though. However, the rash on my forearms is still there. On my right forearm it looks worse than it did yesterday.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Body temperature increased', 'Chills', 'Feeling hot', 'Headache', 'Impaired work ability', 'Injection site pain', 'Myalgia', 'Nausea', 'Pain in extremity', 'Rash', 'Rash erythematous', 'Rash papular', 'Sleep disorder']",1,MODERNA, 924581,NY,46.0,F,"The first AE was simple and was the next day--headache/malaise with a possible facial droop (and right side of my face felt funny) that resolved in 24 hours with 600mg of ibuprofen. I did Zoom with a neurologist who checked up on me later and by then I felt better. What I want to report is that I got a GIANT HIVE exactly one week later at the injection site--raised, white, itchy, indurated, with satellite hives and surrounding erythema. I am a doctor and called an allergist colleague and did FT who concurred it looked like a histamine reaction.. I took 20mg Zyrtec and 400mg ibuprofen. It looked much better the next day. Now it is just red and flat--about 8.5 x 5.5 cm. I have great pictures. Very strange that the injection site was fine and then I got this reaction there.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,"levothyroxine, wellbutrin, diazepam, OCP",None,Hypothyroidism,,"Sulfa (delayed reaction) and then environmental: ragweed, dust, pollen, mold, grass","['Headache', 'Histamine abnormal', 'Injection site discolouration', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria', 'Malaise']",1,MODERNA,IM 924582,CO,61.0,F,Reported feeling minor SOB and felt like her throat was closing about 30-40 minutes after receiving the vaccines. States that she was driving home when she started having DOB. She took OTC Benadryl PO and the issue resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,Gabapentin PO daily; Ibuprofen 300 mg PO prn and Omeprazole PO prn,None,Chronic Back Pain,,Aspartane,"['Dyspnoea', 'Throat tightness']",UNK,PFIZER\BIONTECH,IM 924583,TN,23.0,F,"For past two days since and continuing... fever (tmax 101.6) & GI upset. Diarrhea (frequency) , nausea, stomach pain, poor appetite. And arm pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,UNK,Multivitamin & Zyrtec,None,None,,Amoxicillin / penicillins,"['Abdominal discomfort', 'Abdominal pain upper', 'Decreased appetite', 'Diarrhoea', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 924584,CT,39.0,M,"Fever, chills, myalgias, arthralgias, weakness, nightmares.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2020,01/05/2021,367.0,WRK,"Biktarvy, mesalamine,",,"Hiv, ulcerative colitis",,Nsaids,"['Arthralgia', 'Asthenia', 'Chills', 'Myalgia', 'Nightmare', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924585,IN,38.0,F,"I got my 1st shot Monday evening. I was fine, arm started hurting about 9pm which was to be expected. Tuesday I woke up within 20mins I was nauseous and threw up multiple times. My body was achy and just felt ""blah"". Was weak and dizzy when I stood up. I felt like my insides were on fire (like the worst temperature you've ever had) but didn't have a fever. Felt like my brain was going to swell out of my head and it was the worst headache. I slept all day. Woke up long enough to call the dr and fell back asleep. Halfway through the day I ended up with a fever of 102 (it went down after a few hrs). Today I woke up still feeling weak and somewhat dizzy, spacey.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,Tested positive for covid 12/19.,,,,"['Asthenia', 'Burning sensation', 'Dizziness', 'Feeling abnormal', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'Somnolence', 'Vomiting']",1,MODERNA,IM 924586,FL,61.0,M,Severe night sweats for 3 nights in a row. Severe fatigue for 2 weeks. No fever. No cough. No sick contacts and no contacts became sick.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,PVT,none,none,HTN,,none,"['Fatigue', 'Night sweats']",UNK,PFIZER\BIONTECH,IM 924587,CA,36.0,F,"She arrive at 3:43 and she was nervous before the vaccination for COVID19 ( Morena) because has had anaphylactic reactions to Flonase. She was feeling well up to 15 min post vaccination when she felt she is going to pass out w/o loosing consciousness. She felt weak and feeling fainted when we transferred her to the stretcher. Her BP was 163/106 P=112, Pulse Ox 100% at 16:09. She was resting, received O2 lit per min, she was feeling chest tightness when she used her inhaler Albuterol 2 puffs X2 within 5 min. She was feeling weak and stating ""I am going to pass out."" Her repeat BP=152/110, P=94 with pulse Ox 100% at 16:12 911 called and arrived at 1643",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,PVT,Albuterol 90 mcg Inhaler,,,,Flonase; Anaphylactic reaction,"['Asthenia', 'Chest discomfort', 'Dizziness', 'Nervousness']",1,MODERNA,IM 924588,CO,61.0,F,The individual was premedicated with 25 mg of Benadryl IM in the L arm. She was given the COVID Pfizer vaccine approximately 10-15 minutes after receiving Benadryl. Reported feeling like her throat started closing about 10 minutes after receiving the vaccine. She was provided with 2 doses of PO Bendaryl that she would take home with her. Instructed to take Benadryl PO q 8 hours for the next 72 hours. Family came to pick her up to take her home. She reported feeling better prior to leaving.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Gabapentin PO daily; Ibuprofen 300 mg PO daily and Omeprazole PO daily,None,Chronic Back Pain,,Aspartane,['Throat tightness'],UNK,PFIZER\BIONTECH,IM 924589,CA,,F,"Patient received the second dose of the covid vaccine on 01/06/2021. c/o of fever, chills, hot flashes (face), numbness of the Left buttock, soreness of Left breast, dizziness, headache few hours after the injection. She is concerned about the numbness of the Left buttock and sore Left breast. The injection site was on the Left arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Breast pain', 'Chills', 'Dizziness', 'Headache', 'Hot flush', 'Hypoaesthesia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 924591,TN,26.0,F,"Abdominal rash beginning approximately 2 hours after vaccine administration. Severe sharp right shoulder pain beginning approximately 2 hours after injection, lasting 3 days, resulting in inability to move arm away from rib cage. Excessive fatigue despite rest that has continued into Day 6, and has not recovered from this at the time of this report. Patient has been unable to participate in daily life or attend work shifts.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,PUB,Multivitamin. Vitamin D supplement,,Peripheral neuropathy,,"Sulfa, lexapro, bee stings","['Fatigue', 'Impaired work ability', 'Injected limb mobility decreased', 'Injection site pain', 'Loss of personal independence in daily activities', 'Rash']",1,MODERNA,IM 924592,MO,56.0,F,"Chills, body aches began about 12 hours after injection. Side effects lasted approximately 24 hours. Tylenol resolved side effects for about 3 hours after taking it. Had to wait additional time to take more.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,,,"HRB, depression",,"Stadol, septra, statins","['Chills', 'Pain']",2,PFIZER\BIONTECH,IM 924593,CO,52.0,M,"On 1/3/2021, I broke out with shingles outbreak in my face. I have never had this before.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,01/03/2021,17.0,PVT,None,None,None,,None,['Herpes zoster'],1,PFIZER\BIONTECH,IM 924594,KS,43.0,F,"1815: pt complained mild dizziness, O2:97 %, BP: 115/83, HR: 86, pt given 50 mg Benadryl orally, ate some almonds and chips, not redness or swelling at site 1830: pt stated she was feeling better, requested to go home",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,"Protonix, Wellbutrin, Allegra, Synthroid, Thrintellix",,"Depression, Reflux, migraines",,"Latex and Benzoin, hx of mild local reaction to MMR vaccine",['Dizziness'],2,PFIZER\BIONTECH,IM 924596,KY,59.0,M,"Approximately 4 hours after injection, laid down to sleep, was woken up by moderate pain in/ around the right hip bone, It was progressed to thigh being very tender/sore, as well as whole right leg ached/hurt with feelings of neuropathy. About 8 hours after injection continues to get worse, with right calf ""burning situation"" and soreness to the touch on right thigh. Cold chills Arm appears to be fine. No pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,Levothyroxine 112mcg Sertraline 100mg 1x a day Clonazepam 2mg ( 2 at night) Vitamin D12 1x weekly 325 mg Asprin daily cardvadel 25 mg 2x's a day B12 sub-lingual 1 am. Daily Vitamin,Sinus Infection about 2 weeks before vaccination,Hashimoto's Thyroid Disease ALS diagnosis,,NKA,"['Arthralgia', 'Burning sensation', 'Chills', 'Neuralgia', 'Pain in extremity', 'Pain of skin']",1,MODERNA,SYR 924597,CA,48.0,U,"I received the vaccine at 7:30 am on 1/4. At 11 pm, I had electric tingles in my lips and my throat felt ice cold and like mental. At 11:30pm I developed significant tachycardia. My base line resting heart rate is 68-87. I heart rate was 120-130. My rate was pounding out my chest. At 3 am on 1/5, I went to the ER because of the persistent tachycardia and developing chest pain. I has SVT and PVCS. Tool tylenol 1 g and benadryl 50 mg. By 7am by symptoms resolved. Exhausted the whole rest of the day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2020,01/04/2020,0.0,PVT,"Clartin 10 mg po qday; , Alvesco 160 mcq 2 puffs inhaled twice a day.",,,,environmental allergies,"['Chest X-ray', 'Chest pain', 'Electrocardiogram', 'Fatigue', 'Heart rate increased', 'Laboratory test', 'Oropharyngeal discomfort', 'Palpitations', 'Paraesthesia oral', 'Supraventricular tachycardia', 'Tachycardia', 'Troponin', 'Ventricular extrasystoles']",1,MODERNA,IM 924598,MN,55.0,F,Developed sore arm and fever 100-101F by 2AM 1-4-2021. Resting heart rate increased to 90-136 beats per minute (usual resting heart rate 60-65 beats per minute) by 6AM.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,SEN,None.,Tested positive for COVID 19 12-21-2020.,None,,Sulfa,"['Blood test', 'Electrocardiogram normal', 'Heart rate increased', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 924599,WA,58.0,F,"Headache, nausea, dizziness, swelling in injection site arm and pain from site location to wrisg",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,"Topomax, Imitrex, Aimovig, atorvastatin, Lisinopril, LaMotrigine, Lexapro, 80mg Aspirin, vitamin D, Norco 5/325, Fioricet",,"MS, Chronic migraine, Chronic pain syndrome, chonic lower Lumbar with sciatica left side, Chronic left shoulder pain",,,"['Arthralgia', 'Dizziness', 'Headache', 'Injection site pain', 'Injection site swelling', 'Nausea', 'Pain in extremity']",1,MODERNA,IM 924600,OH,37.0,F,Patient experienced left sided facial tingling and left sided head ache,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,,,Hx of stroke,,Iodine,"['Headache', 'Paraesthesia']",1,MODERNA,IM 924601,NY,28.0,F,Redness with swelling and warmth at site of the vaccine ... 1 week after I got it. Is that normal?,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,PVT,Lialda 4g/day Skyla iud,No,No,,None,"['Vaccination site erythema', 'Vaccination site swelling', 'Vaccination site warmth']",UNK,MODERNA, 924602,IA,46.0,F,Rash on upper body,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,WRK,Colestipol,None,None,,None,['Rash'],1,MODERNA,IM 924603,IL,28.0,M,"Patient returned about 2 hours after receiving vaccine complaining of chest tightness, shortness of breath and arm and chest pain. Patient declined rapidly and could not breath. Called 911 and administered 1 dose of Epipen 0.3mg. Patient's breathing improved immediately. Patient went to ER for further workup.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PHM,Unknown,Unknown,Unknown,,Penicillin allergy,"['Chest discomfort', 'Chest pain', 'Dyspnoea', 'General physical health deterioration', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 924604,OH,34.0,F,"1/6/21: 1245 am. Chills. Fever, headache, body aches, fatigue 1/6/21: 1:30pm tmep 99.7, body aches. Fatigue. Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Keppra, keflex (for acne), vitamin c, vitamin d, folic acid, multi vitamin",None,"Epilepsy, depression",,None,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924605,MI,59.0,F,Mild itching began at the injection site on approximately 1/1/21 and the itching has become more intense. Redness and slight swelling at the injection site began on 1/5/2021. Swelling is definite raised area similar to a hive and is just under 2 inches in diameter. All symptoms are contained at the injection site and have not required any treatment thus far.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PVT,Toprol XL 10 mg 1/2 tablet daily Multivitamin Probiotic Methyl-Sulfonyl-Methane 1000mg 2 capsules daily Cranberry Extract Loratidine 10mg. daily prn Xanax .25 mg prn for anxiety,None known,Wolff-Parkinson-White Syndrome,,Mold and pine.,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria']",1,MODERNA,IM 924606,OH,33.0,F,"For 3 days following the day I received the vaccine, my injection site was red, itchy, hard and a swollen lump the size of a quarter,maybe even nickel sized. After day 3, the lump had subsided and so had the itching, pain and redness. Now today, day 7 after receiving the vaccine, my injection site is itching so badly it almost burns, it is swollen and back to a red lump nearly the size of a half dollar. I have also developed a dry cough and have overall not felt well since 1/4/2021. Please advise",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PVT,"Lantus, Toujeo, Wellbutrin, paxil, Lisinopril, atorovarsatin, ferrous sulfate, vitamin B12, doxycycline",,Diabetes type 1,,None,"['Cough', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Malaise']",1,MODERNA,IM 924607,WI,28.0,F,"Monday night of vaccine got extreme chills, muscle aches, joint aches. Woke up with a fever of 100.8. Very fatigue. Pounding headache and fatigue all day Tuesday on 1/5/2021. Tuesday night I felt better and was able to get some energy back. Tuesday morning woke up with sore throat. Around 9am got extremely tired and laid down. Started wheezing, throat starting itching and I started coughing. Called on call nurse at health center and they advise me to go to hospital to get checked out. Went to hospital. They gave me Benadryl and prednisone for my symptoms. Kept me for 30 minutes and I fell asleep. Was discharged and prescribed prednisone for the next 5 days if symptoms persist. My diagnosis was adverse drug reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,OTH,"Zoloft, Buspirone and Miralax",Covid 19 virus 12/17-12/28,Depression and Anxiety,,Sulfa medication,"['Arthralgia', 'Chills', 'Cough', 'Fatigue', 'Headache', 'Myalgia', 'Oropharyngeal pain', 'Pyrexia', 'Throat irritation', 'Wheezing']",1,MODERNA,IM 924608,TX,30.0,F,Fever 100.4 (12/31/2020) Fever 101.2 (01/06/2021),Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,None,None,None,,None,['Pyrexia'],1,MODERNA,IM 924609,NJ,28.0,F,Rash and inflammation about 4 inches long and 2 inches wide at the vaccination site. Began on morning of the 7th day after the vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,Junel FE 1/20; 40 mg of Doxycycline,None,None,,None,"['Vaccination site inflammation', 'Vaccination site rash']",1,MODERNA,SYR 924610,NY,64.0,M,dizziness (not true vertigo) started when I woke up to go to work 5:30AM accompanied by nausea. Mild headache came on about noon Dizziness subsided about 3PM and headache about 8PM Nausea lasted until 1/6/2021 about noontime No treatment done for any of the above,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Losartan-hctz 100-25 mg Rosuvastatin 20 mg Pepsid 20 mg,none,hypertension hyper cholesterol,"shingles vaccine, 64 yrs, 9/2020, fever for 3 days, sore arms",sulfur aspirin,"['Dizziness', 'Headache', 'Nausea']",1,PFIZER\BIONTECH,SYR 924611,IL,38.0,F,I couldn?t breath and my blood pressure was abnormally elevated for a prolonged time. It made my head spinned and pressured. My heart was racing rapidly and feeling fainted,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,WRK,"Zyrtec , pantoprazole, Amiovig",None,Dermatomyositis,,None,"['Blood gases', 'Blood pressure increased', 'Blood test', 'Dizziness', 'Dyspnoea', 'Head discomfort', 'Palpitations', 'Vertigo']",UNK,MODERNA, 924612,NV,44.0,M,"Fever, chills, tiredness, muscle pain, joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,"Multi vit, 2000 IU Vit. D, 3000mg Vit. C",None,None,,None,"['Arthralgia', 'Chills', 'Fatigue', 'Myalgia', 'Pyrexia']",UNK,MODERNA,IM 924613,OH,72.0,F,"Chest pain, itching . Pt transported to ER per EMS",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,"Aztreonam, Metformin, Lipitor, Darvocet",,"DM, high cholesterol",,"Keflex, Erythromycin, clindamycin, Tegretol, Flagyl, Vit d3, fragrances, chemicals yellow dye","['Chest pain', 'Pruritus']",1,MODERNA,IM 924614,CA,23.0,F,"arm soreness , dizziness, nausea, headache, new onset cough , body ache, chills, low grade fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,none,none,none,,nkda,"['Chills', 'Cough', 'Dizziness', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 924615,MI,57.0,F,Lymphadenopathy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,"Vitamin d, c, multivitamin",None,None,,Erythromycin,"['Lymphadenopathy', 'Ultrasound scan']",1,PFIZER\BIONTECH,IM 924616,OR,36.0,F,"local swelling, pain, itching, and erythema at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,WRK,Vitamin D supplementation Zoloft 75 mg daily,none,depression and anxiety,,none,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 924617,WA,59.0,F,"Extreme Dizziness, Blurry Vision, Near fainting and Nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/27/2020,1.0,PVT,Metformin,,DM,,Oral Prednisone,"['Dizziness', 'Nausea', 'Presyncope', 'Vision blurred']",1,PFIZER\BIONTECH,IM 924618,CA,62.0,F,"after initial, expected, deltoid aching pain which lasted for a few days, very mild achiness has persisted. at approximately 1.5 weeks (17d), I noticed actual weakness when I attempted to lift weights (5#) above my shoulders. isolated to the left arm, which was the injection site. Exercising now, daily, with very slow response and increased aching. despite history of intermittent radiculopathy, there had been no weakness prior to the vaccine. Is this a reported vaccine AE?",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,WRK,"Climara 0.035mg weekly patch Lorazepam 0.5mg 1/2-1 tab pro, avg 1/2 tab qHS Biotin most days. Magnesium 400mg most nights Vitamin D3 50mcg Vit C 500-1,000mg/d Ibuprofen 600mg OR Aleve 1-2 tabs (220-440mg), 4-5d/wk, once daily. Tylenol 6",none,"neck pain. radiculopathy, positional, of left arm since ~July 2020. psoriasis",,"Clindamycin, Erythromycin, Septra (rash)","['Exercise tolerance decreased', 'Injection site muscle weakness', 'Injection site pain']",UNK,PFIZER\BIONTECH,IM 924619,WA,36.0,F,"Usual sore arm and headache right after the vaccine, followed by body aches, fevers, chills, joint pains, sore throat, cough, swollen lymph nodes, and now a facial rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,PVT,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Lymphadenopathy', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Pyrexia', 'Rash', 'Streptococcus test negative']",1,PFIZER\BIONTECH,IM 924620,,50.0,F,"Itching on R side of neck started 23 hours after injection. Applying OTC steroid cream to itching area 30 minutes after the onset made skin burn. Progressed to large hives and very painful/burning skin along R side of neck over 1.5 hours. 25 mg Benadryl stopped spread of hives but pain persisted. Benadryl taken over the next 24 hours. Hives and skin pain resolved after 24 hours, redness over neck resolved after 2 days, a single scab like lesion remained for one week.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,"Elderberry, Vitamin C, Cranberry supplement, Flonase nasal spray, Claritin gel tab - all taken once daily",None,None,,"Penicllin, Sulfa drugs","['Erythema', 'Pain of skin', 'Pruritus', 'Scab', 'Skin burning sensation', 'Skin lesion', 'Urticaria']",1,MODERNA,IM 924621,NJ,32.0,F,Raised induration rash at injection sire,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,PVT,Birth control,N/a,N/a,,Penicillin,"['Injection site induration', 'Injection site reaction', 'Rash papular']",UNK,MODERNA, 924622,AK,29.0,M,"Client called into Health Center and stated that he got the Moderna vaccine at the clinic this am, 11:00 am. He states that by 3:30 pm he noticed that his eyeball was very red (red Crayola color red but not itchy). He took 25 mg of Benadryl at 4 pm and stated that it was already improving with the Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,None,No,None,,"Erythrocin, Sulfamethoxazol, dytheria toxoid",['Ocular hyperaemia'],1,MODERNA,IM 924623,CA,29.0,M,"101. Fever, chills, body aches , fatigue, malaise, swollen tenderness lymph node lt armpit.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,MULTI VITAMIN,NONE,NONE,,NKDA,"['Chills', 'Fatigue', 'Lymph node pain', 'Lymphadenopathy', 'Malaise', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 924624,MA,53.0,F,I had my vaccine at 910am 12/30/2020. I was sitting in the chair and one of the people walking around checking on people asked me how I was doing . I told her I was feeling a little foggy. She gave me a bottle of water and kept checking on me every few mins. At around 935 she took me into the back with the medics to get my vitals. They hooked me up to their defib machine for my vitals. My BP was 190/111. They did it manually and it was 180/110. I was starting a headache. By the time I left my BP was 165/99. I then went to work. At lunchtime my BP was 148/99. I still had a headache for the rest of the day,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,Metoprolol Succ 50mg.1xday am Trazadone 50mg 1xday pm Atorvastatin 40 mg 1xday pm Famotidine 40mg 1xday pm Humira 40 mg every 2 weeks multivitamin turmeric fish oil probiotic,none,Rheumatoid arthritis hypertension cholesterol Interstitial cystitis IBS,,Sulfas Kiwis,"['Feeling abnormal', 'Headache']",1,MODERNA,IM 924625,NJ,28.0,F,"1.5 inch x 1.5 inch red, swollen, hard, and warm area located about 2 inches from injection site. Area was noticed at 3:00pm 7 days from vaccine date as it was itching - a new symptom.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,WRK,None,None,None,,None,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 924626,UT,43.0,M,Excessive salivation,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,No otc or herbal ptoducts and no prescription or supplements,None,None,,None,['Salivary hypersecretion'],1,MODERNA,IM 924627,MO,36.0,F,"localized swelling, redness, warm to touch, knot x7 days (still continues)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PUB,"Allegra, Levothyroxine",None,"low thyroid, seasonal allergies",,None,"['Erythema', 'Nodule', 'Skin warm', 'Swelling']",1,MODERNA,IM 924628,OH,34.0,F,"1/6/2021 1245 am: chills, fever. Body ache, left arm aching, headache, fatigue 1:30pm: chills, fever, body aches, headache fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Keppra (epilepsy), keflex( acne), vitamin c, vitamin d, vitamin b12. Folic acid",None,"Epilepsy, depression",,None,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924629,CO,32.0,F,"6 days after the shot swollen nodule appeared on injection side above the clavicle below the carotid artery. Nodule is about a nickel size, discomfort when palpated.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/06/2021,6.0,PVT,Daily vitamin gummies with omega 3,,Alpha beta adrenergic hypotension,,Sulfa,"['Discomfort', 'Nodule', 'Swelling']",1,MODERNA,SYR 924630,CA,29.0,F,"FEVER, CHILLS, AND MUSCLE PAIN",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Chills', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 924631,,39.0,F,1 week post injection: redness and swelling at site and pain in left axillary lymph nodes,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,N/a,N/a,N/a,,Sulfa,"['Injection site erythema', 'Injection site swelling', 'Lymph node pain']",1,MODERNA,IM 924632,GA,47.0,F,Headache and fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,WRK,"fluoxetine, fluticasone, Xyzal",none,PMDD,,seasonal allergies,"['Fatigue', 'Headache']",UNK,MODERNA, 924633,NJ,46.0,F,"Received at 9am. Continued arm pain so at 10pm I took Tylenol. Then by 11pm I had shakes, fever 100.4 after Tylenol, weakness all over, massive headache, dizzy, and nausea. I tried to tolerate and wait it out by 11am 1:6/2021 I felt some what better. Fever gone. Headache continues.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/05/2021,4.0,PVT,None,None,None,,Percocet,"['Asthenia', 'Dizziness', 'Headache', 'Nausea', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tremor']",1,MODERNA,SYR 924634,TX,44.0,F,Patient was vaccinated and in the waiting area. 5 minutes after the vaccine patient alerted staff she was having a rapid heart beat. EMS was onsite and responded. EMS personnel monitored patient for a short time. Patient stated she forgot to take her anxiety medication this morning. Patient returned to her vehicle and waited approx 5 more minutes and felt well enough to go home (husband was driving). Informed patient to call 911 or present to nearest emergency room if she starts feeling like she is having additional issues. Patient left site claiming to be feeling fine.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PUB,,,,,,['Heart rate increased'],1,MODERNA,IM 924635,MA,34.0,F,"Patient's left arm became itchy 5 minutes after receiving vaccine. Given 50mg Benadryl PO, itching spread throughout body but did not progress to hives. Patient declined to be transported to ED for monitoring.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,None,None,None,,Morphine Percocet,['Pruritus'],1,PFIZER\BIONTECH,IM 924636,AR,28.0,F,I received my vaccine at 1215 on 12/31/20. At 1800 on 12/31/20 I began to feel mild shortness of breath. I then became dizzy at 1805. At 1815 I developed blurred vision. The dizziness and blurred vision prevented me from standing. I was able to walk with assistance at 1915. The blurred vision lasted until 1915. The dizziness lasted until 2230. At 2000 I had muscle aches and joint pain and could not get comfortable. Muscle aches and joint pain lasted until 1-1-21 at 1930. I did not seek medical treatment. (I working in the ER and did not feel it was severe enough to check in because the shortness of breath was mild and went away shortly after the dizziness began at 1815). I took Benadryl 50 mg at 1930 and 1000mg of Tylenol.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,UNK,None,None,None,,Ceclor,"['Arthralgia', 'Discomfort', 'Dizziness', 'Dyspnoea', 'Mobility decreased', 'Myalgia', 'Vision blurred']",1,PFIZER\BIONTECH,IM 924637,NJ,33.0,F,"Large (4 inches) hot, itchy welt at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/05/2021,7.0,SCH,"Ocrevus infusion, vitamin d3, multivitamin, zyrtec",,Seasonal Allergies Multiple Sclerosis,,Penicillin,"['Injection site pruritus', 'Injection site urticaria', 'Injection site warmth']",1,MODERNA,IM 924638,MI,34.0,F,"I initially had chills, myalgias, headache, and nausea (starting later that evening), which I recognized as normal immune reactions. It lasted until about 24 hours after the vaccine. Over the last week, I?ve had horrible insomnia, waking up multiple times throughout the night with difficulty falling back asleep. I didn?t think much of it other than it?s very unlike me until a handful of other coworkers vaccinated around the same have also been experiencing this.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,"Multivitamin, vitamin c, elderberry, zinc, vitamin D, calcium, protonix, synthroid",None,"Celiac disease, GERD, hypothyroidism",,"Gluten, casein, latex","['Chills', 'Headache', 'Initial insomnia', 'Insomnia', 'Myalgia', 'Nausea', 'Sleep disorder']",1,PFIZER\BIONTECH,IM 924639,MA,62.0,F,"Approximately 4-5 min after leaving the facility in my car after my 15 minute check, I began to feel throat tightness -upper pharynx/larynx region - like something was stuck or like I swallowed something - no difficulty breathing, just constant throat clearing like something was stuck on both sides of my upper pharynx/larynx region. I was monitored by EMS and given 50 mg IM Benadryl. After 30 - 40 min. symptoms cleared.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"Pepcid 20-40 mg every evening Vit D 1,000 IU daily Multi Vit Daily Nasonex two sprays at night",None,"Environmental Allergies - tested 30 yrs ago - mold Lichen Planus - oral Chronic Nasal Congestion Arthritis - hallux rigidus, cervical",,None,"['Sensation of foreign body', 'Throat clearing', 'Throat tightness']",1,MODERNA,IM 924640,MD,36.0,F,I suffered an ocular migraine 5 days post vaccine. Never had one before. Very scary. Zigzag spot in both fields of visions for 10 minutes followed by kaleidoscope vision in the left field for 5 mins. No headache after.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/23/2020,5.0,PVT,Oral contraceptives,None,Asthma,,Penicillin Nickel,"['Migraine', 'Visual impairment']",1,PFIZER\BIONTECH,IM 924641,MI,17.0,U,Patient was under the age of 18 when she received the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PHM,unknown,None,None known,,none,['Product administered to patient of inappropriate age'],1,MODERNA,IM 924642,UT,57.0,M,developed hives today 1/6 after receiving COVID shot on 1/3/2021. The hives are on arms and legs and are itchy. referred to PCP today . Treatment course is currently unknown..,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 924643,VA,27.0,F,"Unspecified general vertigo, general weakness, and occasional nausea starting from morning after vaccination that has been steadily improving day by day. Have tried meclizine OTC to no effect. Vertigo is mild and not impairing. Able to keep balance fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,SEN,None,None,None,,None,"['Asthenia', 'Nausea', 'Vertigo']",1,PFIZER\BIONTECH,IM 924644,TX,51.0,F,"Patient received vaccine, 15 minutes post vaccine patient alerted personnel that her left hand was itching and felt warm on the inside. Patient refused to have EMS check her out, but she wanted to inform staff how she was feeling. Patient was having no other symptoms. Patient stated her hand was feeling better after approx 5 minutes. Patient informed to report to v-safe and call 911 or go to the nearest emergency room if her symptoms worsen. Patient verbalized understanding.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PUB,,,,,,"['Feeling hot', 'Pruritus']",1,MODERNA,IM 924645,NY,42.0,F,"Joint Pain, Cold Chills, Fever of 101.3 Symptoms started roughly 28 hours after injection. Took extra strength Tylenol x2 and drank powerade. Symptoms were resolved by morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Centrum Complete multi-vitamin, Vit-D supplement, Estroven Sleep supplement",none,"Ulcerative Colitis, Non-Celiac gluten sensitivity",same reaction and symptoms to flu vaccines.,"gluten, Onion, Garlic","['Arthralgia', 'Chills', 'Pyrexia']",1,MODERNA,IM 924646,CT,37.0,F,"Moderna COVID-19 Vaccine EUA Chills,swollen lymph nodes on left arm, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,PVT,Levothyroxine,No,Hypothyroidism,,None,"['Chills', 'Fatigue', 'Lymphadenopathy']",1,MODERNA,IM 924648,NY,42.0,F,bells palsy of right eye,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,synthroid vit D3,none,hypothyroidism,,sulfa,['Facial paralysis'],2,PFIZER\BIONTECH, 924649,OH,24.0,F,"When getting the vaccine, person giving shot didn?t make sure needle was screwed onto syringe completely. When needle was in arm and plunger was pushed, contents of vaccine went all down arm. A second injection was given in the same arm. 8 days later, I woke up to swollen, hot red arm at injection site. A swollen and hard lymph node was also felt underneath armpit of the injected arm",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/06/2021,8.0,PVT,Oral contraceptive Doxycycline spironolactone,None,None,,NKA,"['Exposure via skin contact', 'Extra dose administered', 'Induration', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Lymphadenopathy', 'Needle issue']",1,MODERNA, 924650,OH,19.0,F,"Nausea, injection site pain, body aches, headache, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,"Zyrtec, tri-lo-marzia",,Allergies,"Yes, dizziness and nausea following hpv vaccine","Mold, dust mites, amoxicillin, sertraline","['Dizziness', 'Headache', 'Injection site pain', 'Nausea', 'Pain']",1,MODERNA,IM 924651,CA,24.0,M,"Patient received the vaccine around 2:50PM; checked in around 2:46PM. He was seated during his monitoring phase when the nurse reported that the patient was complaining about: ? Dizziness ? Lightheadedness ? Weakness of extremities & general overall weakness ? Fast heartbeat ? These were noted to be part of the signs of severe allergic list for the vaccine. Upon assessment around 3PM, the nurse noted that the patient said he felt some of the symptoms were improving; no shortness of breath noted or facial swelling or rashes. Patient offered juice and crackers and advised to stay and continue monitoring. Patient compliant with plan. Around 305PM patient reassessed and patient started complaining of increasing weakness and dizziness and racing heartbeat. Patient also noted to have labored breathing, pale, clammy and tripoding. Vitals taken = 101/64; 100% in room air; HR = 80; RR = 32; lung sounds clear to auscultation. Patient kept on vital sign monitoring and noted that saturations started decreasing to 90%, then 80%, then down to 70% in a span of several minutes + HR = reduced to 55. Patient also stated he was feeling faint & started feeling very weak & stopped talking & having difficulty breathing. MERT called and patient placed in a wheelchair & oxygen administered. Patient continued to look worse and not as responsive. MERT arrived around 317PM and took another set of vitals and brought patient to ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Unknown,No known history,None reported,,None reported,"['Asthenia', 'Dizziness', 'Heart rate increased', 'Muscular weakness']",1,MODERNA,IM 924652,,28.0,F,arm pain at injection site; fever (102.5); body aches; chills,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,UNK,"Prenatal vitamin, calcium, vitamin d",,,,,"['Chills', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 924654,MA,61.0,F,"Swelling of R jaw, unable to open mouth completely, difficulty eating, some discomfort. I took Motrin for pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,"Omeprazole 40mg, Magnesium with Protein, Fiber",none,"Cancer(s) Colon, breast, endometrial, vaginal",,NKDA,"['Discomfort', 'Mastication disorder', 'Pain in jaw', 'Swelling face', 'Trismus']",1,MODERNA,IM 924655,NV,49.0,F,"Delayed redness, pain and swelling left arm with perceived fever, chills and body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PUB,"Tirosint, Omeprazole, Mulitvitamin, Probiotic",none,OSA Hypertriglyceridemia Hypotyroid Bipolar Barret's Esophagus,,"Cipro, Macrodantin, Amoxicillin, Demoral, Floxin, Percocet","['Chills', 'Erythema', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 924656,VA,30.0,F,I started to notice pain and slight swelling in my left axilla less than a week after receiving my vaccine. There is also swelling at the injection site that goes away and returns.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,OTH,"Spironalacrone, Mirena IUD",,,,NKA,"['Axillary pain', 'Injection site swelling', 'Oedema peripheral']",1,MODERNA,IM 924657,OH,67.0,F,"5 minutes after injection, my feet and palms itched and I was lightheaded but I tried to shake it off and it faded over the next 10 minutes. I did report it and stayed longer and was ok. Then i went straight home and layed down because i did not sleep well night before (was on call ) i awoke 1 hour post injection dry heaving, very nauseated, mild headache, achy, itchy over different parts of my body and weak. Sat up and my face was getting itchier, lips started to swell, tongue started to swell and itch, throat felt like someone was strangling me, had trouble swallowing and trouble breathing. took 2 benadryls immediately and went out into cold air, thought about calling 911 but got better in 10-15 minutes. never have had a reaction like this in my life. have had hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the benadryl worked and I slept due to the benadryl for 5 hours, when I woke up the benadryl wore off and it started again. took more benadryl, and it improved. before bedtime, the benadryl wore off and I had a hard time swallowing my night time meds like my throat was swollen. Took 2 more benadryls, today I am weak and nauseated and ate very little and feel like my face is still red and itchy. I told my sister and she said she is allergic to PEG which i later noted was in the vaccine. i am very disappointed that I had this reaction- I have desparately wanted this vaccine as a medical worker with a lot of covid patients- I onlu hopr this one shot will protect me enough because it is clear to me that i cannot take this vaccine again.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"atenolol 25 mg per day, claritin 10 mg per day, evamist one spray per day, pepcid 20 mg per day, vit b12 3000 mcg per day, vit d 5000 units per day, prenatal gummy vitamin one per day,tylenol 500 mg per day, benadryl 50 mg per day",none,"chronic gastritis, tachycardia, kidney stones. food allergies",swine flu vaccine 1978? was very sick and couldn't walk well,"aspirin, NSAIDS, flexeril, percocet, thiomerosol in any product, caffeine or stimulants, allergic to milk, ?to eggs, ?to bluberries and strawberries, severe to cheese esp cheddar, ?to onions, ? to garlic, ?to grapes, severe intolerance to alcohol","['Asthenia', 'Decreased appetite', 'Dizziness', 'Dysphagia', 'Dyspnoea', 'Erythema', 'Fear', 'Headache', 'Lip swelling', 'Nausea', 'Pain', 'Pharyngeal swelling', 'Pruritus', 'Retching', 'Swollen tongue', 'Throat tightness', 'Tongue pruritus']",1,MODERNA,IM 924658,FL,92.0,F,"Severe Hypotension, Redness, Warmth and sensitivity all over skin surfaces, lack of responsiveness, low oxygen saturation.",Not Reported,,Yes,Yes,2.0,Not Reported,N,12/26/2020,01/05/2021,10.0,SEN,"Caltrate, Vitamin B, Azopt, Ensure, Sertraline, Dulcolax, Benzonatate, Tylenol, Melatonin, Flonase, Imodium, Ativan.","L98.9 Disorder of the skin and subcutaneous tissue, unspecified-Scalp(Primary, Admission), R41.841 Cognitive communication deficit, R13.10 Dysphagia, unspecified, R13.12 Dysphagia, oropharyngeal phase, C44.311 Basal cell carcinoma of skin of nose, R26.81 Unsteadiness on feet, M62.81 Muscle weakness (generalized), R53.1 Weakness, Z74.09 Other reduced mobility, Z74.1 Need for assistance with personal care, D51.9 Vitamin B12 deficiency anemia, unspecified, D64.9 Anemia, unspecified, E87.6 Hypokalemia, F03.90 Unspecified dementia without behavioral disturbance, F32.9 Major depressive disorder, single episode, unspecified, G47.00 Insomnia, unspecified, H40.9 Unspecified glaucoma","L98.9 Disorder of the skin and subcutaneous tissue, unspecified-Scalp(Primary, Admission), R41.841 Cognitive communication deficit, R13.10 Dysphagia, unspecified, R13.12 Dysphagia, oropharyngeal phase, C44.311 Basal cell carcinoma of skin of nose, R26.81 Unsteadiness on feet, M62.81 Muscle weakness (generalized), R53.1 Weakness, Z74.09 Other reduced mobility, Z74.1 Need for assistance with personal care, D51.9 Vitamin B12 deficiency anemia, unspecified, D64.9 Anemia, unspecified, E87.6 Hypokalemia, F03.90 Unspecified dementia without behavioral disturbance, F32.9 Major depressive disorder, single episode, unspecified, G47.00 Insomnia, unspecified, H40.9 Unspecified glaucoma",,"PCN, Sulfa","['Erythema', 'Hypotension', 'Oxygen saturation decreased', 'Sensitive skin', 'Skin warm', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 924659,VA,66.0,F,Severe pain in left arm. Felt like arm had been wrenched from shoulder socket. Pain radiated down arm from shoulder to wrist. Could not lift arm more than halfway to the front or side for 3 days. Took 6 days for all pain to dissipate.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,,None,None,,Penicillin The malaria drug that you take weekly rather than daily,"['Feeling abnormal', 'Joint range of motion decreased', 'Pain', 'Pain in extremity']",UNK,MODERNA, 924660,VA,32.0,F,"Bronchospasm 1.5 hours post injection relieved by 1 puff of albuterol. 12 hours post injection headache. 24 hours post injection chills, aches, malaise, low grade fever. Overall mild discomfort at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Levothyroxine, Losartan, Metformin, propranolol, nortriptyline, omeprazole, vitamin D gummy",None,"Asthma, IBS, hypothyroid, migraines, PCOS,","Pertussis vaccine, approx. 6 months, 1989, fever, arm swelling","Penicillin, Ceclor, mold, pertussis vaccine (childhood), Vancomycin","['Bronchospasm', 'Chills', 'Headache', 'Injection site discomfort', 'Malaise', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924661,CA,34.0,F,"Left armpit pain without mass for 4 days, delayed reaction that did not start until 7 days after vaccine. Initial vaccine reaction w mild sore arm on side of vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/29/2020,6.0,PVT,None,None,None,,"Seasonal allergies, mild","['Axillary pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 924662,,46.0,F,"Redness and burning in eyes, followed by shaking chills and fever with headache and fatigue. Lasted 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Eye irritation', 'Fatigue', 'Headache', 'Ocular hyperaemia', 'Pyrexia']",1,MODERNA,IM 924663,,38.0,F,"I received my COVID-19 vaccine on 12/20/2020, all was fine despite a sore arm. Around the 48-hour mark, I developed extreme dizziness and I received medical care at ER on the 23rd of December.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/23/2020,3.0,PVT,,,,,,"['Dizziness', 'Electrocardiogram', 'Laboratory test', 'Magnetic resonance imaging', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 924664,HI,92.0,F,"At approximately, 1855, I was alerted by caregiver, resident was not responding. Per caregiver, she was doing her rounds and found resident in bed, unresponsive, mouth open, observed gurgling noises and tongue hanging out of mouth. This primary caregiver observed resident at baseline and ambulating after dinner at approximately, 1800 less than an hour prior to incident. This PCG called 911 for EMS and gave report of incident. Resident was taken to Medical Center Emergency Department. At ER, CT scan and X-ray was performed. Per report from ER RN, CT scan and x-ray revealed an intracranial aneurysm and fluid in the lungs. Per RN, resident was still unresponsive and was admitted to Medical Center for observation and comfort measures. This primary caregiver reported to RN, resident recently received the first dose of COVID-19 vaccine on 1/2/21. Primary caregiver received a call from Castle RN at 0700, resident expired at 0615.",Yes,01/06/2021,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/05/2021,3.0,SEN,Metoprolol succ ER 50mg 1 tab PO daily Omeprazole DR 20mg 1 cap PO daily Amlodipine besylate 5mg 1 tab PO daily Aspirin 81mg 1 tab PO daily Carbamazepine ER 100mg 1 tab PO TID Docusate 100mg 1 cap PO daily Multivitamin 1 tab PO daily Olmesa,none,"history of stroke, hyperlipidemia, dementia, GERD, and macular degeneration",,Hydrochlorothiazide,"['Computerised tomogram abnormal', 'Death', 'Intracranial aneurysm', 'Pulmonary oedema', 'Unresponsive to stimuli', 'X-ray abnormal']",1,MODERNA, 924665,MD,46.0,F,"I received the vaccine Dec. 28th, 2020 in my left deltoid. There were no issues until January 5, 2021 in the evening when my arm started to itch. There was increased erythema, mild edema, and urticaria. The area is still red and itchy and while the erythema has increased outside the marked area on my deltoid, it has diminished in how vibrant it is.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,Levothyroxine 100 mcg PO daily.,,,,Bactrim No other allergies,"['Injection site erythema', 'Injection site pruritus', 'Oedema', 'Pruritus', 'Urticaria']",1,MODERNA,IM 924666,OH,49.0,F,Itching and redness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,PUB,"Nifedipine, synthroid, HCTZ, fish oil, Vitamin D, Flonase",None,"Hypothyroid, hypertension",,None,"['Injection site erythema', 'Injection site pruritus']",UNK,MODERNA, 924667,TX,26.0,F,"Moderna COVID-19 Vaccine EUA; 99.5 fever, chills, muscle aches, night sweats",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,"Birth control pill, Zyrtec, symbicort",None,Asthma,,NKDA,"['Chills', 'Myalgia', 'Night sweats', 'Pyrexia']",1,MODERNA,IM 924668,MA,38.0,F,"Tingling in nose and lips within minutes of vaccination. No treatment needed. Self-resolved within a few minutes. Same symptoms a few days later, again no treatment needed. Lasted only a few minutes. This was also along with painful injection site, chills and body aches. Swollen lymph node in left underarm. Non-pain rash that developed 1 week after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"Vit C, B12, and Vit D",none,None,,PCN as a child,"['Chills', 'Injection site pain', 'Lymphadenopathy', 'Pain', 'Paraesthesia', 'Paraesthesia oral']",1,MODERNA,IM 924669,CO,36.0,F,"Itching, splotchy rash on torso",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,MIL,,None,None,,"Bee venom, fire ants","['Rash', 'Rash macular', 'Rash pruritic']",1,MODERNA,IM 924670,AZ,31.0,F,"Headache the afternoon/evening the shot was given. Skin reaction 2 inches in diameter at injection sight for 9 days that is red, sore, hard, hot to the touch, and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PUB,none,none,none,,none,"['Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Skin reaction']",1,MODERNA,SYR 924671,VA,50.0,F,"Approximately 2 hours post injection, my left arm started to feel warm and itchy. I was wearing a thick hoodie and when I pulled my sleeve up, it was covered with hives and welts. My lower lip started to feel full and nose started to feel runny. I was close to a pharmacy when I discovered the hives so I went and bought Tylenol and Benadryl and took it immediately. After that, I headed to the emergency room of the facility where I got my covid 19 -Pfizer injection. When I got there, my right arm started to feel itchy as well and I also broke out in a rash on my left upper chest. They gave me a steroid injection and steroid taper prescription. When I got home that night, my right forearm broke out in hives. The next couple of days, my left arm intermittently had hives.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,"Synjardy, Metformin, Amlodipine, Lisinopril, Premarin Cream, Clobetasol, Elidel, triamcinolone, Zyrtec, Calcium, Vit D, Biotin, Vit B-12, Epipen-food allergies",,Diabetes and Hypertension,,"Meds-Polymycin, Neosporin, Bacitracin Food-Calamari and Crabs","['Lip swelling', 'Pruritus', 'Rash', 'Rhinorrhoea', 'Skin warm', 'Urticaria']",1,PFIZER\BIONTECH,IM 924672,MT,57.0,F,Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left eye and left forehead above the eye. The patient reported feeling ?out of sorts? with a tingling or numbness from her shoulder to her neck and tingling in the left side of her face. She felt light headed when standing and her feet hurt. She was given diphenhydramine 25 mg and observed for an hour and a half at which time she reported feeling better . Her temperature was 97.5 F at 13:23 and 97.9 at 13:45. She left work early and went to the walk-in clinic later that evening. She reported that the clinic said all of he vital signs were normal and they did not note any specific problems. She took second diphenhydramine 25 mg. She was contacted at around 8:30 AM on 1/6/2021 and reported that she was feeling better.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,"Metformin, atorvastatin, citalopram",None,Diabetes,,Prozac -upset stomach,"['Dizziness', 'Erythema', 'Eye pain', 'Feeling abnormal', 'Flushing', 'Headache', 'Hyperhidrosis', 'Hypoaesthesia', 'Pain in extremity', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 924673,OR,51.0,F,"Patient related complaints of burning sensation in her right hand and fingertips. 119/77, 99.4, 18, 88, 98% on room air. Patient was observed for 45 minutes and stated that she felt fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,,,,"Pneumonia vaccine, first stated anaphylaxis, then said it wasn't. Vague on when the incident occurred.",,"['Body temperature increased', 'Burning sensation']",UNK,MODERNA,IM 924674,AZ,36.0,F,"Days 1-6 after receiving vaccine, arm developed a large (half-dollar sized), red, firm, swollen area that was hot to touch; it turned into a bruise and then was completely gone by day 6 (12/28/2020). On 1/1/2021, I noticed that my arm was again sore; upon inspection, I found that the welt had returned. It was again large, red, swollen, hot to touch and very itchy. As of today (1/6/2021), it is just a slight bruise.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,01/01/2021,10.0,WRK,Escitalopram 20mg daily Tizanidine 2mg daily,None,Migraine,,Penicillin Zomig Imitrex,"['Contusion', 'Erythema', 'Induration', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Skin warm', 'Urticaria']",1,MODERNA,IM 924675,VA,45.0,M,Fever 102 and taken Tylenol 650 mg q8h for 3 dose Fever spike again twice in 24 h Symptoms resolved on 01/06/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Protonix 40 mg bid,GERD,None,,No,['Pyrexia'],2,PFIZER\BIONTECH,IM 924676,GA,59.0,F,"On day after vaccine had chills and fever(99.7) for ~ 24 hours. Also had muscle and joint pain, very sore arm at injection site, mildly swollen lymph nodes. All noted on handout to be possible side effects. ***Day 2 after vaccine has very red rash all over neck, chest, abdominal and back areas with some itching that lasted ~ 72 hours but was less visible each day after initially noted. No medical treatment sought as resolved on its on",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Losartan Potassium,25 mg, Calcium 600 w/D 3, Vitamin C, 500 mg, Zinc, 50 mg, Vitamin D3, 50 mcg, Aspirin, 81 mg",None,HTN(dx ~ 2 years),,"Macrobid, Keflex, Loratadine, Lisinopril","['Arthralgia', 'Chills', 'Injection site pain', 'Lymphadenopathy', 'Myalgia', 'Pruritus', 'Pyrexia', 'Rash', 'Rash erythematous']",1,PFIZER\BIONTECH,IM 924678,VA,29.0,F,"Still have a welt, hot to the touch, and knot after a week from getting the vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,UNK,None,"Nausea, headache, redness, swelling at injection site, and welt (knot)",Chronic kidney disease High blood pressure Anxiety Depression,,Cephalexin Augmentin Doxycycline Lidocaine Duloxetine,"['Headache', 'Injection site erythema', 'Injection site nodule', 'Injection site reaction', 'Injection site swelling', 'Nausea', 'Urticaria']",2,MODERNA,SYR 924679,WY,29.0,F,"Severe hives 4 hours after injection, red and hot around injection site for 3 days now",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PUB,"Qbrexa, fluoxetine, diclofenac, topiramate",None,Migraines,,None,"['Injection site erythema', 'Injection site warmth', 'Urticaria']",1,MODERNA,SYR 924680,CO,48.0,M,At 1pm on January 6th I became fatigued and had a low grade fever of 99.1,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"multivitamin, probiotic, fish oil, vitamin D.",,,,,"['Fatigue', 'Pyrexia']",1,MODERNA,IM 924681,FL,,F,"Left temporal H/A, stabbing that comes and goes. B/P 207/107. Sent to ER",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,['Headache'],1,MODERNA,IM 924682,TX,60.0,F,"Stiff neck, headache, ear ache, fatigue, arm ache and weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Zinc, vitamin D, Ajovy",,Migraines,,,"['Asthenia', 'Ear pain', 'Fatigue', 'Headache', 'Musculoskeletal stiffness', 'Pain in extremity']",1,MODERNA,SYR 924683,CO,78.0,M,Dry cough,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,Losartan 50mg 2Xdaily Toprol 12.5mg /day Thyroxine 50mcg/day,none,none,,none,['Cough'],1,PFIZER\BIONTECH,IM 924684,SD,20.0,F,"Pain in left arm from 1/5 at 8am to 1/6 at 1pm. Ibuprofen did not help and it was hard to be able to move arm or it be touched. Fever, body aches, joint pain, and chills on 1/5 for about 7 hours. Tylenol and Ibuprofen did not break fever or body aches. 1/6 no body aches, fever, chills but very slight pain in left arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"Sprintec birth control, Adderall XR, Nitrofurantn, Ibuprofen",Probable Covid-19 on 12/23,Mitral Valve Prolapse,,None,"['Arthralgia', 'Chills', 'Injected limb mobility decreased', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 924685,NY,32.0,F,left axillary lymph node swelling and pain that started 5 days post vaccination of the same side arm. swelling and pain subsided in 3 days and completely disappeared. symptoms were mild.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/22/2020,5.0,PVT,None,none,none,,none,"['Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 924686,NY,35.0,F,"Cellulitis like reaction. Area where injected started with a red like rash and spreading down arm. Very painful, hard and red. Took Benadryl and Motrin. Will keep monitoring. If it becomes worse will go to ER. About 2 hours after injection I noticed the redness and throughout the day it was spreading. The This same thing happened the last 2 times I had the flu shot and they gave me antibiotics before. I was able to catch I t early this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,Birth control and a multivitamin,None,None,Flu shot in sept 2020 and sept 2019. ER diagnosed me with cellulitis from the flu shot. I was 34 and 35.,None,"['Cellulitis', 'Erythema', 'Induration', 'Pain in extremity', 'Rash erythematous']",UNK,MODERNA, 924687,TX,66.0,M,"Moderna COVID-19Vaccine EUA Arm soreness, headaches, nausea, chills, fatigue, dizziness; started the morning after I received the injection and lasted 24 hours. 48 hours later I still have fatigue and headaches. (It is noteworthy that I had COVID in October, recovered at home, in bed for 3 weeks. This was very similar)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PUB,"Olmesartan; Pantoprazole; Lipitor; Zinc, Vitamin C, Vitamin D",None,Chronic pyelonephritis - right kidney;,,None,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pain in extremity']",1,MODERNA,IM 924688,ND,19.0,F,"Patient became woozy when she returned to her second floor work area. Her colleagues came to get me in the auditorium. When RN and I reached patient she was very weak, she was sitting in a chair. I instructed her colleauges to call 911 immediately. Patient was having a little trouble breathing. I think she was scared. I gave her 10 mlL of benedryl and RN administered a 0.5 mL dose of epinephine in her left arm. Patient was helped to the floor and her feet were elevated. RN put on a blood pressure cuff. Before she could get a reading, the paramedics were there and took over. Patient was transported to Hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,OTH,Unknown,None reported,No chronic disease or health concerns.,,None reported,"['Asthenia', 'Dizziness', 'Dyspnoea', 'Fear']",1,MODERNA,IM 924689,WA,46.0,F,"Every bone in my body hurt, I was unable to get out of bed until 4:00pm because of a overwhelming not well feeling (a little Nauseous and dizzy but not to the point I was throwing up I also had a low-grade fever 99.7 and could not get warm. Over the past 2 hours I am feeling a little better where I can walk short distances and type in my phone I did not go to the doctor or hospital",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,Tamoxifen Venlafaxine ER Multi vitamin Vitamin D,None,None,,None,"['Bone pain', 'Dizziness', 'Feeling cold', 'Malaise', 'Mobility decreased', 'Nausea', 'Pyrexia']",1,MODERNA,SYR 924690,NC,38.0,F,"Three to four hours after vaccine had bruising, major loss of range of motion, severe sharp pain, elevated temp and chills due to reaction of injection site Treatment given 24 hrs later- strong antibiotics, anti inflammatory, exercise, and three days out of work Due to loss of function of left arm due to inflammation",Not Reported,,Not Reported,Not Reported,,Yes,N,01/05/2021,01/05/2021,0.0,PUB,"Benadryl, vitamin d, vitamin b12",None,Pericardial effusion (fluid around heart) mostly resolved after surgery few months ago Year around allergies,,None,"['Body temperature increased', 'Chills', 'Contusion', 'Impaired work ability', 'Inflammation', 'Injection site reaction', 'Joint range of motion decreased', 'Musculoskeletal disorder', 'Pain']",1,MODERNA,IM 924691,MA,36.0,F,"Left arm soreness for 24 hours. On 1/6/21 evening, I noticed raised red rash at the site of injection. It is itchy. This is new.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,,,PVT,Vitamin d3 5000 units daily,None,Had elevated cholesterol in summer 2020 but improved to normal with diet and exercise on recheck in November 2020,,Allergy to Bactrim (increased lfts) and nickel allergy,"['Injection site reaction', 'Pain in extremity', 'Rash papular', 'Rash pruritic']",UNK,MODERNA,IM 924692,MO,40.0,F,"On day 7 I developed significant itching to injection site along with large area of induration, redness and heat. It continues into today. Tender to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,"Synthroid, lexapro, melatonin",,"Diabetes, anxiety, hypothyroidism",,Pcn,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 924693,WA,40.0,M,"Fevers, chills, myalgias",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,Cetirizine,none,none,,Seasonal allergies,"['Chills', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924694,NC,29.0,F,At 6 am the morning after vaccine I experienced extreme fatigue. Chills. Extreme perspiration. Low grade fever. Vomiting. Nausea. Sore arm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PHM,Prenatal vitamins. Bore thin drone birth control,None,None,Flu vaccine one time 8 years ago had flu like symptoms. Has been fine with flu shot since,None,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 924695,TX,35.0,F,Left arms swollen and painful to touch. Headaches and very painful body aches and muscle aches. Occurrences started 01/06/2021 at approximately 5:30 am.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,,,Asthma,,"Allergic to nuts, tea ,ibuprofen","['Headache', 'Myalgia', 'Pain', 'Peripheral swelling', 'Tenderness']",1,MODERNA,SYR 924696,IN,24.0,F,Severe left arm pain. Body aches that started 30 hours after vaccine and lasted 24 hours. Decrease in the amount of breast milk I was producing for 3 days. Congestion.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,UNK,,,,,,"['Pain', 'Pain in extremity', 'Respiratory tract congestion', 'Suppressed lactation']",1,MODERNA,IM 924697,TN,25.0,F,"Patient received the vaccination on 12/30, later that evening and into the morning the patient had pain and redness at the injection site, patient took 2 Tylenol and noticed the effects went away 24 hours after receiving. On 1/6 around 2 pm patient noticed redness and fever at injection site. Around 8 pm, pain at injection site started and patient notified the pharmacy. Patient was advised to take Motrin and use an ice pack on the injection site. Patient unable to take temperature at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,WRK,None,None,None,,None,"['Injection site erythema', 'Injection site pain', 'Pyrexia']",1,MODERNA,IM 924698,NY,48.0,F,Swelling and pain in right axillary lymph node. Started 1 week after vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/29/2020,7.0,PVT,"Ibuprofen, Tylenol",None,None,,Clindamycin,"['Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 924699,,29.0,M,"c/o lightheadedness, flushing",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,cats,"['Dizziness', 'Flushing']",1,MODERNA,IM 924700,TX,36.0,F,symptoms started about 8 hours after with sore left arm and general body aches. increasing symptoms over the next 12 hours. severe body aches. unable to life left arm. fatigue. muscle pain all over body. headache nausea. neck stiffness. runny nose. chills. pain with inspiration. fever. 102.3 was the peak I was able to record at about 30 hours post vaccine. the fever finally broke approx 48 hours post vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,PVT,Cymbalta 80 mg po daily,,Major Depression,,Demerol Levaquin Medrol,"['Chills', 'Fatigue', 'Headache', 'Joint range of motion decreased', 'Musculoskeletal stiffness', 'Myalgia', 'Nausea', 'Pain', 'Pain in extremity', 'Painful respiration', 'Pyrexia', 'Rhinorrhoea']",1,MODERNA,IM 924701,GA,44.0,M,"?Moderna COVID-19 Vaccine EUA Headache, fatigue, chills, weakness, dizziness, fever and R shoulder soreness. Last for about 18 hrs. soreness lasted 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,"Aspirin 81, Vitamin D, MVI",None,Obese,,None,"['Arthralgia', 'Asthenia', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Pyrexia']",UNK,MODERNA, 924702,IN,42.0,F,"Received vaccine 1/4/21 at 11:40am. Started at 1/5/21 3am with severe aching in knees, lower back & pelvis, nausea, vomiting, headache, fever up to 103, fatigue. Symptoms lasted until 1/6/21 9pm. Took ibuprofen & Excedrin around the clock to control body aches & fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,"Hydrochlorothiazide, Mobic, Lexapro, Vitamin D,",None,"Hypertension, anxiety, depression, chronic back pain",,Lortab,"['Arthralgia', 'Back pain', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pelvic pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting']",1,MODERNA,IM 924703,NJ,56.0,F,"Anxiety, fever 101.4, lightheaded, dizzy, nausea and vomiting, sensitivity of hands and feet, headache, body aches. Lasted about 24 hours. Tylenol relieved headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/05/2021,4.0,PVT,,,,,,"['Anxiety', 'Dizziness', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Sensitive skin', 'Vomiting']",1,MODERNA,IM 924705,AK,25.0,F,"Less than 15 minutes after receiving vaccination, the patient began noticing tingling and muscle twitching from the right elbow down to her hands that began to progress in the severity of twitching. There were not other symptoms reported by the patient, breathing was NOT affected, and sensation was not painful. The patient was not treated but observed for a full 30 minutes. The patient was comfortable leaving and instructed to return to clinic if worsening of symptoms or new symptoms developed. 2 hours later the patient called the clinic and informed that her symptoms had resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,Humiara (adalimumab),,Rheumatoid arthritis,,None,"['Muscle twitching', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 924706,IL,34.0,F,"Evening of the 18th I became dizzy and nauseated, worsening the next day. It felt like how I have patients describe migraines where noises make them feel dizzy, but I did not get a headache. Movements, lights and noises made the symptoms worsen. I was feeling better by the 21st and now symptoms have resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/18/2020,2.0,PVT,Multivitamin,None,None,,Amoxicillin,"['Dizziness', 'Hyperacusis', 'Motion sickness', 'Nausea', 'Photophobia']",1,PFIZER\BIONTECH,IM 924707,ND,28.0,F,"Patient developed fatigue and fever after a few hours. The next day she chills, body aches, headache, continued fever. Took Tylenol to treat. Arm is sore and she is unable to use it; swollen but no rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Phentermine, and BCP",None,None,HPV caused chills and body aches for 12 hours,Naproxen,"['Chills', 'Fatigue', 'Headache', 'Mobility decreased', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 924708,NY,33.0,F,"I have a history of migraines, but since starting emgality injections in september, had been doing much better. I only had 1 migraine in November an hasn't had any in Dec until 12/30 (6 days post vaccine). I took my rescue medication (ubrelvy), and the migraine came back again the next day, so I took my medication again. On 1/1 the headache was really bad and the medication did not work. All I could do was sleep and when waking up from a nap I took my medication again, and it didn't help again. This is the first time my migraine has not responded to my medication. I still had the headache on 1/2.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/30/2020,6.0,PVT,"Ortho tri cyclen lo, sertraline, topiramate, crestor, coq10, allegra, emgality, ubrelvy",,"Migraines, hyperlipidemia, anxiety",,"Augmentin, penicillin","['Migraine', 'SARS-CoV-2 test negative']",1,MODERNA,IM 924709,NJ,50.0,F,"One hour after the vaccine was administered, my jaw hurt then my face went numb on both sides. I was driving when this happened. When I arrived at home my daughter immediately told me my face had a droop on the right side Facial numbness has continued. I notified occupational health and spoke with a Dr. He advised to monitor and no treatment at this time",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,B complex vitamin daily,None,None,,Erythromycin,"['Facial paralysis', 'Hypoaesthesia', 'Pain in jaw']",UNK,MODERNA,IM 924710,OH,43.0,F,I had body aches and chills. Took Motrin 800 mg. Started at 830pm on 1/4/2021 and got better 1/6/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,"Hi potency multivitamin, super b complex, liquid calcium with vitamin d3, montelukas-t sod, junel",None,None,,None,"['Chills', 'Pain']",1,MODERNA,IM 924711,OH,25.0,F,"12/29 Pain + swelling at injection site, nausea, headache, muscle and joint pain, fever 12/30 Pain + swelling at injection site, muscle and joint pain 12/31 Pain at injection site 1/1 No symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,"Albuterol inhaler, Nuvaring birth control, multivitamin, fish oil, vitamin D3, zinc, probiotic",None,Asthma,,None,"['Arthralgia', 'Headache', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,IM 924712,HI,41.0,F,"Arm soreness for 3days. Rash appeared around injection site about 5-6 days ago, not sure. Site is itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,MIL,Prozac,None,"Anxiety, Vertigo, back pain","Small pox, 2008, headaches, fever, general sickness",None,"['Injection site pruritus', 'Injection site rash', 'Pain in extremity']",1,MODERNA,SYR 924714,WI,26.0,M,"Fever Tmax 101.6, diffuse body aches, frontal headache, fatigue, malaise; lasted for ~4 hours, until I took 650mg acetaminohen x2; then symptoms improved and continued to improve throughout the rest of the day. In the evening hours, symptoms were pretty much gone. I took 650mg acetaminohen x2 again. On the following day after onset of symptoms, no symptoms were noted. Symptoms, in my opinion, were out of proportion to what has been described as average in the literature and what seem to be the common side effects of peers who have received the same vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,None,None,None,,None,"['Fatigue', 'Headache', 'Influenza virus test negative', 'Malaise', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 924715,,35.0,F,"Injection site arm soreness, bad headache, fatigue that began about 6 hours after the vaccine and then lasted for 24 hours, but improved over time",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"Bystolic, Seasonique, Digestive Advantage Lactose Formula, Flonase",None,"PVCs, hypertension, lactose intolerance, menstrual migraines",Influenza in October 2020- had a bad headache for consecutive 2 days,None,"['Fatigue', 'Headache', 'Injection site pain']",1,PFIZER\BIONTECH,SC 924716,IN,24.0,F,"I felt very fatigued starting around 6pm. Severe chills began around 9pm, followed by a fever. The fever went from 100.1 to 102.2 over the course of about an hour (11:30pm-12:30pm), at which time I took 400mg of ibuprofen. The fever was 102.1 thirty minutes after taking the ibuprofen. Along with the fever I experienced tachycardia, body and muscle aches, and moderate to severe deltoid pain at the injection site. I believe the fever broke around 3:00am. The fatigue and body aches lasted about 24 hours since they began, but the majority of the rest of my symptoms were gone after the fever. The arm pain at injection site was noticeable and painful for about 72 hours before subsiding.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None,None,None,,Allergy to hair dye one time,"['Chills', 'Fatigue', 'Injection site pain', 'Myalgia', 'Pain', 'Pyrexia', 'Tachycardia']",1,PFIZER\BIONTECH,IM 924717,MN,31.0,F,"Severe left deltoid pain. Pain both at rest and with use. Hurts more with use. Feels like I was ""punched in the arm."" At rest it's so painful I can't focus on other things.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,Sertraline 75mg once daily,,Anxiety disorder,,Allergy to PCN and minocycline -rash to both,['Pain in extremity'],UNK,MODERNA,IM 924718,NY,51.0,M,"Tiredness, Chills, Fatigue, Coughing starting on Day 1. Loss of taste and smell on Day 3. Also tested positive on SARS-CoV-2 Antigen (rapid Covid-19 swab) on 1/6/2021, 2 days after administration of the Moderna vaccine. Question - Is taking the Moderna vaccine giving a positive test on the Covid Antigen test?",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,SCH,Allegra,None,None,,None,"['Ageusia', 'Anosmia', 'COVID-19', 'Chills', 'Cough', 'Fatigue', 'SARS-CoV-2 test positive']",1,MODERNA,IM 924719,WV,52.0,F,Fever of 103 F two nights in a row. Aches as bad as when I had Covid-19 in October. Shortness of breath. Fatigue.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,Zoloft singular melatonin,None,Depression anxiety seasonal allergies,,Sulfa drugs Ampicillin,"['Dyspnoea', 'Fatigue', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924720,PA,35.0,F,Moderna COVID-19 Vaccine EUA Adverse events noted: Approximately 2 pm-altered sensation in maxillary lip and nose Approximately 4 pm-tingling on scalp just above nape of neck 6:18 pm-tingling in right hand Each of the above events lasted about one minute From approximately 6 pm to present-significant amounts of sneezing and a runny nose.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,Centrum multivitamin Excedrin Rogaine Beyaz,None,Raynauds Low iron Migraine headaches with aura,,No known allergies,"['Paraesthesia', 'Rhinorrhoea', 'Sensory disturbance', 'Sneezing']",UNK,MODERNA,IM 924721,MO,25.0,M,"Started off with chills, headache and fatigue around 1am. I was also sweating profusely. I took my temp and it was 100.3. Was not able to sleep more than 4hours. I also had terrible nightmares during the little time I was asleep. I started to feel better around 11am that next morning however, I?ve had diffuse abdominal pain and several episodes of diarrhea throughout the afternoon and evening.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,No,No,No,"I had chills, and fatigue after my first Covid-19 dose. Symptoms started roughly 16-18hrs after injection",No,"['Abdominal pain', 'Body temperature increased', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Insomnia', 'Nightmare']",2,PFIZER\BIONTECH,SYR 924722,IL,96.0,F,"Severe shortness of breath, administered inhaler, hydralazine with no improvement. Dr. notified. Sent to ER",Not Reported,,Not Reported,Yes,,Not Reported,U,01/02/2021,01/06/2021,4.0,SEN,"Tylenol, amlodipine, ASA, Atorvastatin, combivent, cyclobensap","neck fracture, CKD 3, HTN, HL, edema, heart disease",asthma,,"cortisone, morphine",['Dyspnoea'],UNK,PFIZER\BIONTECH,IM 924723,MI,29.0,F,"PRESYNCOPE BP 70 SYSOTLICALLY, IV INITIATED AND TAKEN TO EMERGENCY DEPT",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,PVT,"JUNEL 1/20,",NO,NO,,NO,['Presyncope'],1,PFIZER\BIONTECH,IM 924727,UT,56.0,F,Raised heart rate within an hour of vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PUB,Singular Synthyroid Zyrtec Pantoprazol Baby aspirin Trintellix Ativan Lamictal Trazadone Sprevia inhaler Symbicort inhaler,Loop recorder inserted surgically on 12/14/2020. Cold/sore throat 12/28/2020 and Covid test was negative,Asthma History of TIA Severe depressive disorder and anxiety Hypothyroidism Gerd/IBS,,Penicillin Sulfa Ceplalaxin Senna laxative,['Heart rate increased'],1,MODERNA,SYR 924728,CA,26.0,M,"Fatigue, feeling drained, fever, headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Tylenol,None,None,,None,"['Asthenia', 'Fatigue', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 924729,MT,48.0,F,"3""X3"" hard lump, swollen, warm to touch, rash and significant itching to area on left upper arm that started 3 days after vaccination. On 1-5-21 I took 50mg of Benedryl to help with swelling and itching with no response. On 1-6-21 I took one dose of Xyzal with no response.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/31/2020,3.0,PVT,"Levothyroxin, Losartan, Hydrochlorothyozide, Prozac, Vit D, Vit C",none,"Asthma, hypertension, depression, environmental allergies","tetanus vaccine in approx 2015 caused red swelling, hot to touch area on arm. This went away within a week.",Sulfa,"['Induration', 'Peripheral swelling', 'Pruritus', 'Rash', 'Skin warm']",1,MODERNA,IM 924730,IN,42.0,F,"Flu-like body/muscular aches, severe pain at injection site. Continued to worsen for 24 hours. Noticable improvement after 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Pristiq, vitamin c",None,None,,None,"['Influenza like illness', 'Injection site pain', 'Myalgia']",1,MODERNA,IM 924731,OK,65.0,F,"I woke up at 2:30 in the morning with severe chills that lasted on and off for over twelve hours. I also had diarrhea and and a headache. My sense of taste is also off, nothing taste right.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,"Multi-vitamin, claritin, apple cider vinegar",none,Pro-lapse mitrovalve,,"caffeine, cephalosporins, ciprfloxacin, and erythromycin","['Chills', 'Diarrhoea', 'Headache', 'Taste disorder']",1,MODERNA,IM 924732,KY,34.0,F,Shingles rash outbreak,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,WRK,,,,,,['Herpes zoster'],1,MODERNA,SYR 924735,MI,41.0,F,"TOUNGE SWELLING , FELT HOT 5 MIN AFTER POST INJUCTION. EPINEPHRINE GIVEN. ED VISIT",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,"ACYCLOVIR, PRENATAL VIT",NO,HSV,,CODIENE,"['Feeling hot', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 924736,WA,48.0,F,"One week after the injection, I had urticaria and angioedema near the site of the injection. I still have it. It goes between better and worse but hasn?t gone away.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PHM,Bcp,None,None,,None,"['Angioedema', 'Injection site reaction', 'Injection site urticaria']",UNK,MODERNA,IM 924737,TX,32.0,F,"Tender Axillary lymphandopathy on 01/05/2021 (day 6) Injection site redness, swelling, induration, and itching on 01/06/2021 (day 7)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PVT,None,None,None,,None,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 924738,OR,52.0,M,Left armpit lymph node swollen to the size of a grape and painful.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,OTH,"Omeprazole, levothyroxine",,,,Sulfa,"['Axillary pain', 'Lymphadenopathy']",1,MODERNA,IM 924739,GA,29.0,M,"It started with mild irritation in my throat that made cough (dry cough). Then I started to have severe chills, body fatigue and coughing stopped. I now have fever (100.8) runny nose, my eyes hurt, still having body fatigue but less chills. I'm taking acetaminophen and Advil.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,SCH,None,None,None,,no known allergies,"['Chills', 'Cough', 'Eye pain', 'Fatigue', 'Pyrexia', 'Rhinorrhoea', 'Throat irritation']",UNK,PFIZER\BIONTECH, 924740,TX,24.0,F,"Redness, swelling, hot to touch 4in by 3 in, itchy at injection site going on day 9 and getting bigger Hives to face 3 hours after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PHM,Ibuprofen,NONE,None,,NKA,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Urticaria']",1,MODERNA,IM 924741,,30.0,F,"After 48 hours my arm felt fine 7 days after my first vaccine my arm got swollen (like a big lump) , warm, red and tender to touch again I?ve also had unusual tiredness during the past 7 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,None,None,None,,None,"['Erythema', 'Fatigue', 'Pain in extremity', 'Peripheral swelling', 'Skin warm']",1,MODERNA,SYR 924743,KS,23.0,M,"Sore arm, body aches, and nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PUB,None,None,None,,None,"['Nausea', 'Pain', 'Pain in extremity']",1,MODERNA,IM 924744,NH,51.0,F,"15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but then felt presyncopal. Sat down, drank water and ate a cookie. The feeling did not subside. After about another 20 minutes, felt tingly all over. After about 5 minutes of that, the tip of my tongue started too tingle. I alerted the staff and they checked my pulse (nl in the low 60s) and my BP (normal SBP 112). They gave me liquid Benadryl 25 mg and the tingling immediately stopped but I still felt lightheaded. They transported me to the ED. I was given 1 L of fluid and monitored and rested for about an hour, then I felt fine. No other tests or meds given",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,PVT,citalopram 10 mg daily,none,none,,none,"['Dizziness', 'Paraesthesia', 'Paraesthesia oral', 'Presyncope']",1,PFIZER\BIONTECH,IM 924746,WA,56.0,F,"Lightheadedness was the first 2 days after the vaccine (arm discomfort). Felt numbness on the left upper lip 2-3 hours after vaccine, but noted facial droop 3 days later. Numbness is improving at this time. Some fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/21/2020,3.0,PVT,,,Hypothyroidism d/t Hashimoto's thyroiditis PCOS Cervical Segment dysfunction,,ASA Sulfa Adhesive and Tape,"['Dizziness', 'Facial paralysis', 'Fatigue', 'Hypoaesthesia oral', 'Limb discomfort', 'SARS-CoV-2 antibody test positive']",1,PFIZER\BIONTECH,IM 924747,FL,34.0,F,"Since the vaccine I have been having right sided hearing loss. Two days after my first dose I felt like I was underwater when talking to people, as their speech was distorted. I also felt pressure in my ear, as if it was filled with fluid, and was unable to ""pop"" my ears. I was evaluated by an ENT and there was no infection or fluid in my ear. It started to get better a little. After my second dose, the symptoms worsen. My hearing loss was back worse than the original time and this time I had tinnitus constantly. I also had chills, fevers, myalgia, back pain, and headaches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,01/04/2021,19.0,WRK,Flonase,none,none,,no known allergies,"['Acoustic stimulation tests abnormal', 'Back pain', 'Chills', 'Headache', 'Myalgia', 'Pyrexia', 'Tinnitus']",2,PFIZER\BIONTECH,IM 924748,AZ,49.0,F,"Immediately following injection: warm flushing feeling to right side of my neck and face. One hour after: fatigue, dizziness and nausea 12 hours: fatigue (slept for 19 hrs post injection) , dizziness, nausea 24 hours: fatigue, dizziness 48 hours: dizziness Present day: dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,PVT,Zinc Vitamin B Vitamin C Vitamin D3 Turmeric,None,None,,None,"['Dizziness', 'Fatigue', 'Hot flush', 'Hypersomnia', 'Immediate post-injection reaction', 'Nausea']",UNK,MODERNA,IM 924749,UT,39.0,F,Cellulitis like symptoms at site Of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PUB,Bupropion,None,None,,None,['Injection site cellulitis'],UNK,MODERNA, 924750,MI,49.0,F,"THROAT TIGHTNESS, FINGERS WARM. EPI GIVEN. TRANSFERED TO ER",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,PVT,"ASA, VUIT D,PEPCID,INSULIN (NOVOLOG AND GLARGINE)MOBIC,CRESTOR",NONE,"SLEEP APNEA, DM TYPE 2. OSTEO ARTHRITIS",INFLUENZA VACCINE,"NICKLE, HYDROMORPHONE , SHELLFISH, CLONIDINE,MORPHINE","['Epinephrine', 'Feeling hot', 'Throat tightness']",1,PFIZER\BIONTECH,IM 924751,UT,42.0,F,"swelling at site of injection, itching, hot one week after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,lisinopril baby aspirin,none,permpartum cardiomyopathy,,monistic 7,"['Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 924752,IL,42.0,F,"Had soreness of the injection site for two days after the administration. Then no issues. On the 8th day noticed Swelling and pain at the injection site, difficulty in raising the arm. Contacted my healthcare provider who advised to report to CDC, take anti-inflammatory and cold compress",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,OTH,none,none,none,,None that I know of,"['Injection site pain', 'Injection site swelling', 'Mobility decreased']",1,MODERNA,IM 924753,CA,66.0,M,"Became weak on Monday 12/28/20 in the evening and fell off the chair . Was semi-unconscious for 5 minutes . When I came to my wife took my BP 88/60 . I felt weak that evening and went to bed early. I woke up fine that next day. No symptoms since. No medical follow required,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/28/2020,5.0,PVT,"Trazodone, lexapro, Effexor, atarax, Zyrtec",No,Insomnia and depression,,No,"['Asthenia', 'Depressed level of consciousness', 'Fall']",1,PFIZER\BIONTECH,IM 924754,KS,44.0,M,Itchy and small red rash about the size of a silver dollar. No pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,PUB,Simvistatin,None,None,,NKDA,"['Pruritus', 'Rash erythematous']",1,MODERNA,SYR 924755,NY,23.0,F,"Rash on dorsal surface of right hand Tx: lotion, Aleve Rash not yet resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,None,None,GERD,,None,['Rash'],1,PFIZER\BIONTECH,IM 924756,WV,56.0,F,"Approximately 3 1/2 hours after I received my vaccine I was sitting and talking on the phone. All of a sudden my hands, arms and head became numb and I had a feeling of pressure. I took 25 mg of Benadryl and within about 15 minutes the symptoms were gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PHM,Armour thyroid 30 mg,None,Psoriasis,,Wheat,"['Head discomfort', 'Hypoaesthesia']",1,MODERNA,SYR 924757,CA,28.0,M,"Malaise, Headache, Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,WRK,None,None,OSA,,Adhesives,"['Headache', 'Malaise', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924758,VA,35.0,F,"Hives on face, neck, arms Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,None,None,None,,"Soy, corn, wheat, almond","['Fatigue', 'Urticaria']",1,MODERNA,IM 924759,TX,41.0,F,"Pain at injection site, body aches, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,UNK,None,None,None,,None,"['Chills', 'Injection site pain', 'Pain']",UNK,MODERNA, 924760,MI,60.0,F,BLOTCHES OVER ENTIRE BODY NO OTHER SYMPTOMS. TREATED WITH BENADRLY OBSRVED 30 MIN AND RASH RESOLVED,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,ELEVIL,NO,CHRONIC AIR,,SULFA,['Rash macular'],2,PFIZER\BIONTECH,IM 924762,AZ,38.0,F,"Moderate skin reaction. Became raised, red, and slightly painful. Created a golf ball size circle of irritation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PUB,Zoloft Iron,None,PCOS Migraines Sleep apnea,,NKA,"['Erythema', 'Pain of skin', 'Skin irritation', 'Skin reaction', 'Skin swelling']",UNK,MODERNA,SYR 924763,WA,31.0,F,"reported all over body hives, swelling at vaccine site and slight swelling at the mouth around lips",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,none,none,none,,none,"['Injection site swelling', 'Lip swelling', 'Mouth swelling', 'Urticaria']",1,MODERNA,SYR 924764,UT,33.0,F,"About 12 hours after I received the second dose of the covid vaccine, I started to get severe chills and headache followed by fever that lasted all night and was up to 101.4 F. The fever improved this morning around 9 am, however I continued to have headache, myalgia, and fatigue all day. I also have intermittent nausea and difficulty standing or walking around because of feeling like I will pass out. I feel slightly improved tonight but still not normal. I called the employee health this morning to inform them.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Vitamin B12, vitamin D",None,None,,None,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924765,,29.0,F,"Jan. 4: felt dizzy and sluggish rest of day Jan. 5: injection site swollen, very painful where she was having difficulty raising the right arm, chills, headache, fever Jan. 6: fever and right arm soreness She?s taking over the counter meds",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Chills', 'Dizziness', 'Headache', 'Injected limb mobility decreased', 'Injection site pain', 'Injection site swelling', 'Pain in extremity', 'Pyrexia', 'Sluggishness']",1,MODERNA,IM 924766,WA,55.0,F,"MODERNA COVID-19 Vaccine: Left arm below shot large red area appeared with tender spot in cneter or shot area. It is hot, raised with size has growing since Monday to size of hand over biceps area. I have applied cortozone -10 , and anti ich topical to area with out results. I took benadryl on 1..6.20. Honestly looks like a infected bug bite or skin infection. Intially had a solid fluid hard area.. no w area just tender.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/03/2021,7.0,WRK,multi vitamin,"none at time, two weeks earlier cold",none,,none,"['Injection site erythema', 'Injection site pain', 'Injection site warmth']",UNK,MODERNA,IM 924767,NY,60.0,M,Shaking chills achy knees hurt,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,None,None,No,,None,"['Arthralgia', 'Chills', 'Pain']",1,MODERNA,IM 924768,AR,27.0,F,"Woke up next day (12/30) with a hot red mark and bruising around injection site and soreness and pain. Later noticed lots of swelling in deltoid. Took the temperature of red spot that afternoon and it was 100.2 F. On 1/5 in the morning it appeared to be going away, but that night came back. 1/6 morning had soreness and now looks kind of like a bullseye",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PHM,"Montelukast 10, levocetirizine 5 two to three per day, venlafaxine ER 150, famotidine 40, azelistine nasal spray. Flovent 220",None,"Asthma, alpha gal syndrome, dermigraphica, vasomotor sinusitis",,"Rosemary and alpha 1,3 alpha galactose","['Injection site bruising', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 924769,MO,38.0,F,"About 1 minute after receiving the vaccine, I suddenly felt hot and sweaty. After about 20 minutes, I began experiencing mild itching on my face, chest and upper body (no hives or rash) and my face was flush. At about 40 minutes, began experiencing nasal congestion, runny nose and and a slight tickle in the back of my throat. A few hours later, all symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Depo provera, generic Zrytec, Berberine, Turmeric.",,,,"Compazine, Benzoin.","['Feeling hot', 'Flushing', 'Hyperhidrosis', 'Nasal congestion', 'Pruritus', 'Rhinorrhoea', 'Throat irritation']",1,PFIZER\BIONTECH,SYR 924770,,59.0,F,"Jan. 5: developed redness (more than quarter size), itchiness and the site was warm to touch She?s taking over the counter meds.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/05/2021,8.0,UNK,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 924771,MI,52.0,F,"RAPID HEART RATE 150-160, SHAKY FEELING 10 MIN POST VACINATION",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,PVT,"ZOLOFT, LAMICTAL, SYNTHROID",NONE,DEPRESSION,,"CLINDAMYCIN,AMOX, BIAXIN, DOXYCYCLINE,ZITHROMAX PCN,, SULFA","['Heart rate increased', 'Nervousness']",1,PFIZER\BIONTECH,IM 924772,IL,69.0,M,Moderate Left Arm for 3-4 days Pain Clear runny nose on day 4 post vaccine. Last 2 hours. disappear spontaneously,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,multivitamins,None,T2DM Hypertension,,None,"['Pain in extremity', 'Rhinorrhoea']",1,PFIZER\BIONTECH,IM 924773,AZ,45.0,F,"Fatigue, dizzy, flu like ache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,"Fluoxetine HCL 20 MG, Levothyroxine 50MCG",None,"Hypothyroidism, Chronic Depression",,None,"['Dizziness', 'Fatigue', 'Influenza like illness', 'Pain']",1,MODERNA,IM 924774,,51.0,M,Jan. 1: developed redness & soreness to left upper arm (injection site) Jan. 5: injection site with increased redness and painful to touch He?s taking over the counter meds.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/01/2021,3.0,UNK,,,,,,"['Injection site erythema', 'Injection site pain']",1,MODERNA,IM 924775,CA,27.0,F,"Fever, Headache, Fatigue, and Stomach ache, Nausea, Muscular pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,None,None,None,,None,"['Abdominal pain upper', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,IM 924776,NC,46.0,F,Red splotches on body - mainly arms,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,PVT,,,Auto-immune disease (lupus),Itching at the injection site after flu vaccination,Latex,"['Rash erythematous', 'Rash macular']",1,PFIZER\BIONTECH,SYR 924777,MI,31.0,F,"SCRATCHY THROAT , FULL FEELING IN BACK OF THROAT , TREATED WITH BENADRYL. OBSERVED AND RELEASED FROM CLININC",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,NO,NO,PREDIABETES,,AMOX,"['Feeling abnormal', 'Oropharyngeal discomfort']",1,PFIZER\BIONTECH,IM 924779,CA,46.0,F,As of 1/5/2021 i experienced itchiness at the injection site. The next morning more itchiness and redness and swelling at the injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,WRK,"pantoprazole, tylenol,",none,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA, 924780,CO,37.0,M,"I experienced fever, chills, muscle pain and fatigue. Took 3 doses of ibuprofen over a span of about 18 hours. Symptoms just went away about 36 hours after I received the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,"vitamin d, ibuprofen",,,,none,"['Chills', 'Fatigue', 'Myalgia', 'Pyrexia']",UNK,MODERNA, 924781,OR,44.0,F,"Had tingling in feet shortly after vaccine. Waited 15 minutes, was cleared to go home, on walk to car, migraine aura started. I rarely get migraines. Got worse and worse as I drove home, could barely see. Severe headache followed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,"Vitamin D, iron, vitamin C",None,Psoriasis,,Sulfa,"['Condition aggravated', 'Headache', 'Migraine with aura', 'Paraesthesia']",1,PFIZER\BIONTECH,SYR 924782,CA,28.0,M,Swollen lymph node in left armpit for the past 3 days. Somewhat sore.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,PVT,None,None,None,,Mangos,"['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,SYR 925669,MS,36.0,F,"01/05/2021 at 1451: Received Covid-19 Vaccine (Moderna) IM to L deltoid, during drive-thru 1512: Patient c/o feeling hot/flushed, confused/light-headed, states ""heart racing."" Appears pale in color. Patient was placed supine with legs elevated. BP 164/100, HR 94, RR 24, unable to determine O2sat, patient with gel manicure, would not register. Denies SOB. Denies chest pain. Patient remained A&O x4. Assisted and monitored by RN; second RN; third RN; and Fire Department. EMTs contacted. 1523: BP 142/86, HR 82, RR 20, color returned, A&O x4. Assited to sitting position. Reports ""feeling better"". Refused to go hospital/ER for further observation. 1523 patient contacted her father to come to Health Dept. to pick her up and take her home to avoid driving. Patient remained with RN until arrival of father. Fire Department remained with patient as well. 1545 Patient's father arrived to take her home, RN reports to writer that patient became SOB and light headed, and pain upon transfer to her father vehicle. EMS contacted, unable to obtain IV access x1 attempt. EMS placed patient on non rebreathing and transported to Emergency Department.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PUB,None reported per patient,None reported per patient,None reported per patient,,None reported per patient,"['Confusional state', 'Dizziness', 'Dyspnoea', 'Feeling hot', 'Flushing', 'Impaired driving ability', 'Pain', 'Pallor', 'Palpitations']",1,MODERNA,IM 925671,ME,21.0,F,(Reported) Fever 100.2 degree F body aches/HA/pain at injection site/fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,,,PVT,BCP/ nasal saline,None,None,,None,"['Fatigue', 'Injection site pain', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,IM 925672,MN,44.0,M,Employee reported throat was starting to swell; epinepherine was given at 9:30am.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,OTH,,,,,Reports allergies to: shellfish and bees,"['Epinephrine', 'Pharyngeal swelling']",1,PFIZER\BIONTECH,IM 925673,TX,87.0,F,Fever 100.3 degrees Ache body ARm swollen with rash,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,"Clonazepam, ASA, Lovastatin, Losartan, Quetiapine, Escitalopram",No,"Dementia, Breast Cancer",,PCN,"['Pain', 'Peripheral swelling', 'Pyrexia', 'Rash', 'SARS-CoV-2 test']",1,MODERNA,IM 925674,TX,73.0,F,"12/31/2020 Weakness, acid reflux, 1/1/2021 Weakness, chills, diarrhea No fever, cramps in abd. 1/5/2021 1320 pm - Left message. 1/6/2021 1021 pm - "" "".",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,"Sucralfate, Calcium, Pantoprazole",GERD,"GERD, Back Pain",,Codeine,"['Abdominal pain', 'Asthenia', 'Chills', 'Computerised tomogram thorax', 'Diarrhoea', 'Gastrooesophageal reflux disease', 'Influenza virus test', 'SARS-CoV-2 test']",1,MODERNA,IM 925675,IA,24.0,F,"right upper arm red, swollen, warm to touch and painful",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,,,,,None,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 927797,VA,44.0,F,"Individual received COVID 19 vaccine. Started to feel dizzy approx. 15 minutes after vaccine. Pt then started to have hypertension and increased confusion. EMS called, pt transported to hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,WRK,blood thinner,"(R) PE, Hypertension, leen+ transfusion for low H/N",,,,"['Condition aggravated', 'Confusional state', 'Dizziness', 'Hypertension']",1,MODERNA,IM 927808,NE,59.0,F,"Symptoms started about 3 hrs after receiving Moderna COVID vaccine. Lightheadedness, headache, extreme fatigue, body (back mainly, legs) feel heavy & leg heaviness started next day. heaviness resolved in 3 hours. Next day fever T=98.5 B/P=136/80, P=84 & fatigue is improved. Referred to Dr - PCP",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,Victoza injection daily,Diabetes Type 2,None,,NKDA,"['Discomfort', 'Dizziness', 'Fatigue', 'Headache', 'Limb discomfort', 'Pyrexia']",1,MODERNA,IM 927818,NY,55.0,F,"1/5 Chill-fever 101.6 @6:45A Reaction 9pm 116 Resolved. Went to ED, covid rapid (-) prior covid (-) Antibodies result (-) 2nd dose",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2020,01/05/2020,0.0,PVT,Synthroid 75mg- Nexium Vit D,Cataract Sur Nov/Oct,0,,Aspirin/PTU,"['Chills', 'Pyrexia', 'SARS-CoV-2 antibody test negative', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 927827,MS,43.0,F,"01/05/2021 @ 15:41 Received COVID-19 Vaccine (moderna) IM to L deltoid 1543: Patient c/o ""anxious feeling"" and dizzy. pt placed supine with legs elevated. BP 106/60, patient reports is a normal BP for her; HR 74, RR 20. Denies SOB, denies Chest pain, 1545: Patient reports ""feeling better,"" assisted to sitting position. Denies any further complaints, refuses need for EMS/ER refused to contact family member for transport. Report she has never had a reaction to a vaccine in the past. She reports hx of anxiety and feelings of anxiety ""in these situations."" Patient is A&O x4. VS stable. Patient reports ""feeling ok to drive."" No further s/sx.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,Losartan 20mg daily; Prozac 40mg Daily,HTN; Anxiety; Panic Disorder,,,PNC; Sulfa; Keflex,"['Anxiety', 'Condition aggravated', 'Dizziness']",1,MODERNA,IM 927828,RI,24.0,F,"C/o fever, chills, headache & stomach ache 1 day after receiving first dose",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,Unknown,Unknown,Unknown,,None,"['Abdominal pain upper', 'Chills', 'Headache', 'Pyrexia', 'SARS-CoV-2 test']",1,MODERNA,IM 927829,NY,60.0,U,Pt. reports (L) deltoid and arm soreness x 3 days following vaccine. Pt. states 'persistent lightheadedness and headaches unrelieved by Ibuprofen with slight double vision.',Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,PVT,,,,,,"['Diplopia', 'Dizziness', 'Headache', 'Injection site pain', 'Pain in extremity']",UNK,MODERNA,IM 927830,FL,71.0,F,"Abdominal pain, chills, n/v, dark urine, elevated LFT's, Bilirubin in urine. Patient currently admitted to hospital",Not Reported,,Not Reported,Yes,,Not Reported,N,12/22/2020,12/22/2020,0.0,PVT,"Synthroid, Tagamet, Lipitor, Protonix",None,"Hypthyroid, GERD, Arthritis",,NKA,"['Abdominal pain', 'Bilirubin urine present', 'Chills', 'Chromaturia', 'Laboratory test', 'Liver function test increased', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH, 927849,MA,42.0,F,"Raised, Red, itchy bump (larger than quarter size) under the site of injection. Painful/sore when pressed on. Last for 5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/30/2020,8.0,PVT,None,None,None,,"Ibuprofen, Percocet","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 927863,MI,34.0,F,"Skin over injection site reddened, raised, and tender. Increased warmth over site. Moderna COVID-19 Vaccine EUA",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,01/06/2021,21.0,PVT,Vitamin C/Vitamin D3 albuterol 90mcg inhaled prn,None,asthma,,zithromax,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 927878,KY,38.0,F,"Headache, Body aches, swollen eyes/face, dry scratchy feeling when breathing, low grade fever I called staff with pharmacy COVID Vaccination team and notified her of the adverse reaction. The employee was seen at the medical clinic by ""staff"", Dr, nurse practitioner. Employee was informed that these were all common side effects + she should go ahead and take the second vaccine when it's scheduled on 1/26/21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,SEN,NONE,NONE,Rheumatoid Arthritis,,PenicilliN,"['Eye swelling', 'Headache', 'Pyrexia', 'Respiration abnormal', 'Swelling face']",1,PFIZER\BIONTECH,IM 927918,WA,74.0,F,Started out as a localized bruise several days after injection. On Saturday 1/2/21 noticed a pink spot where the bruise occured. The spot was 4 inches long & 2 inches wide. Spot is warm to touch & was itchy. The spot remained the same until 1/5/21. It did not take anything to help with itching,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/01/2021,8.0,WRK,Vitamin D,None,None,,NKA,"['Contusion', 'Pruritus', 'Skin discolouration', 'Skin warm']",1,MODERNA,IM 927932,WI,38.0,F,"20 minutes post immunization patient developed hives over face and neck, stated tongue felt like it was tingling, patient felt flushed and warm and stated she ""just didn't feel right"" patient evaluated by provider - claritin 20mg given, vitals taken after another 30 minutes of being observed patient stated she""felt better""-hives gone",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Synthroid, Omeprazole, Vitamin D, Elderberry gummy, Nexplanon",none,,,"Amoxicillin, sulfa, erythromycin, PCNS, venom - honey bee, wasp","['Feeling abnormal', 'Feeling hot', 'Flushing', 'Paraesthesia oral', 'Urticaria']",1,PFIZER\BIONTECH,IM 927936,MO,,M,"Patient reports that he began feeling tightness in his throat just a couple of minutes after receiving vaccine. Reported symptoms to RN at 0936. During assessment, he reported an increase in severity of symptoms. Epinephrine administered & patient transferred to ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,PVT,,,,,,['Throat tightness'],1,PFIZER\BIONTECH,IM 927938,HI,73.0,M,Received Moderna vaccine on 12/29/2020. 12/30/2020 fever of 100.4 Tylenol given and monitored and fever went down. 12/31/2020 Chest x-ray completed and sent to the hospital and admitted with pneumonia. 1/3/2021 reported by the hospital that Covid-19 results were positive. He had had Covid-19 positive results back on 11/4/2020 prior to vaccine.,Not Reported,,Not Reported,Yes,,Not Reported,U,12/29/2020,12/30/2020,1.0,SEN,,,,,,"['Chest X-ray abnormal', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 927940,SD,91.0,U,I was informed by the staff that pt. had fainted about 1/2 hour after receiving The Covid vaccine. The staff immediately called 911 & EMS arrived in about 15 minutes *Collapsed approx. 30 min after shot Arrived 11:45AM & she was responsive WEIGHT: 149.8 as of 12/20/20,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,SEN,,,,,none listed,['Syncope'],1,PFIZER\BIONTECH,IM 927941,CA,28.0,F,Employee called to report that she developed headache and body aches this morning rated 7/10. She is 26 week pregnant. Instructed her to notify her PCP or OBGyn.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,UNK,,,,,,"['Headache', 'Pain', 'Pregnancy']",1,MODERNA,IM 927942,FL,68.0,F,patient presents with redness and swelling of vaccine site. Treatment: Cephalexin 500 mg one QIDx7d,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/04/2021,5.0,OTH,"Letrozole, Synthroid, Simvastatin, Lisinopril",,"Hypertension, Thyroid Disease, Elevated Lipids, Heart murmur",cellulitis with subsequent hospitalization following tetanus vaccine - no additional info,NKDA,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 927943,CA,65.0,M,"Patient c/o Cough, Headache, Fatigue Body aches x 2 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,,,PVT,"Cyclobenzapine 5 mg BID, Nabumetone 750mg",NONe,NONe,Sore Arm,,"['Cough', 'Fatigue', 'Headache', 'Pain']",1,MODERNA,IM 927944,CA,62.0,M,"PATIENT REPORTED A SORE ARM THE DAY FOLLOWING THE VACCINATION. THE PAIN SUBSIDED BY THE END OF THE SECOND DAY. ON DAY 4, THE PATIENT AWAKENED WITH FEVER, HEADACHE, BODY ACHES, CHILLS, SEVERE FATIGUE, SOB AND COUGH. ON MONDAY, JANUARY 4, THE WAS GOT FEELING ANY BETTER AND WITH TO SEE A PROVIDER AT MEDICAL CENTER. HE WAS GIVEN A CHEST X RAY AND LABS. HE WAS GIVEN A RAPID FLU AND COVID ANTIBODY PCR TEST BOTH NEGATIVE. HE DID NOT REPORT TO THE HEALTH DEPARTMENT AND THE HOSPTIAL DID NOT THINK FEEL THE SYMPTOMS WERE RELATED TO COVID VACCINATION. HEALTH DEPARTMENT ONLY FOUND OUT TODAY DURING F/U PHONE CALL WITH PATIENT. PATIENT IS RECOVERING AT HOME. AS OF TODAY, HE FEELS HE IS GETTING BETTER.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/26/2020,4.0,PUB,NONE,NONE,ASTHMA,,NKDA,"['Blood creatinine increased', 'Blood urea increased', 'Chest X-ray normal', 'Chills', 'Cough', 'Dyspnoea', 'Fatigue', 'Full blood count abnormal', 'Glomerular filtration rate decreased', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia', 'White blood cell count decreased']",1,PFIZER\BIONTECH,IM 928084,,52.0,F,"SkinRash, Rash, 6cm x 2cm circular area of erythema rt deltoid. no discharge, skin is intact Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,OTH,,,,,,"['Injection site erythema', 'Injection site rash', 'Rash']",1,MODERNA,IM 928098,,48.0,F,SkinRash,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,OTH,,,,,,['Rash'],1,MODERNA,IM 928107,,34.0,F,Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,['Pyrexia'],1,PFIZER\BIONTECH,IM 928119,,33.0,F,"Headache, Myalgia, NauseaVomiting, Injection site pain Headache 5 minutes after injection. Nausea and vomiting 1 hour after injection. Body aches and injection site pain also reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 928132,,49.0,M,Dizziness & Sedation,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Dizziness', 'Sedation']",1,PFIZER\BIONTECH,IM 928141,,67.0,F,Headache Fatigue; Arm soreness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 928149,,40.0,M,"Dizziness, HYPERtension, flushing, tingling on one side of the body- opposite side from injection Narrative: dizziness, tingling, flushing, on left side of head down to left foot immediately after injection at 1148. BP increased to 168/104 with HR of 103 at 1211.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/05/2021,,OTH,,,,,,"['Body temperature increased', 'Dizziness', 'Flushing', 'Hypertension', 'Immediate post-injection reaction', 'Paraesthesia']",1,MODERNA,IM 928160,,33.0,F,"Dizziness, NauseaVomiting, HYPOtension, pallor Narrative: 1207 - felt dizzy, tingling, turned pale, felt nauseated. Laid down in chair, BO 107/70 HR 75 1225 BP 122/85 HR 71 standing, felt stead released back to work at 1223.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Dizziness', 'Hypotension', 'Nausea', 'Pallor', 'Vomiting']",1,MODERNA,IM 928190,,39.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Headache'],1,PFIZER\BIONTECH,IM 928191,,42.0,F,Headache Injection site pain/soreness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Headache', 'Injection site pain']",1,PFIZER\BIONTECH,IM 928192,,48.0,F,Headache Neck stiffness Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Headache', 'Musculoskeletal stiffness']",1,PFIZER\BIONTECH,IM 928212,,51.0,M,Myalgia Pain at injection site and arm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Injection site pain', 'Myalgia', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 928221,,25.0,M,"Headache, NauseaVomiting, chills, low grade fever, arm soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Headache', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 928228,,48.0,M,"Headache, Fever, Diarrhea, temp 99.0 very achey, sweating",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Diarrhoea', 'Headache', 'Hyperhidrosis', 'Pain', 'Pyrexia']",1,MODERNA,SC 928242,,37.0,F,"Headache, Myalgia, felt warm-feverish Narrative: Taking OTC NyQuil every 4-6 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,Influenza vaccine-has cold-like symptoms,,"['Feeling hot', 'Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 928244,,27.0,F,"Rash Rash to left of inj sire and growing, red warm, itchy. Swollen lymph nodes L side neck",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,OTH,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth', 'Lymphadenopathy']",1,MODERNA,IM 928250,,26.0,F,Numbness in hand Narrative: Numbness in left fingers lasted 10-15 minutes,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Hypoaesthesia'],1,PFIZER\BIONTECH,IM 928252,,48.0,F,"Myalgia FATIGUE,eyelids and forehead, itching. At injection site sore,swelling,reddness and itching. Also going from hot feeling to cold.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/31/2020,3.0,OTH,,,,,,"['Eyelids pruritus', 'Fatigue', 'Feeling of body temperature change', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Myalgia', 'Pruritus']",1,MODERNA,IM 928257,,45.0,F,itching at site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,OTH,,,,,,['Injection site pruritus'],1,MODERNA,IM 928261,,47.0,F,"Dizziness, Headache, Lightheadedness; Injection site pain Narrative: Dizzy and lightheaded 14 minutes after injection. Headache and injection site pain for 2 days after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Dizziness', 'Headache', 'Injection site pain']",1,PFIZER\BIONTECH,IM 928268,,58.0,F,Metallic taste; injection site pain Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Dysgeusia', 'Injection site pain']",1,PFIZER\BIONTECH,IM 928285,,39.0,F,"Dizziness, NauseaVomiting, Arm soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Dizziness', 'Nausea', 'Pain in extremity', 'Vomiting']",1,PFIZER\BIONTECH,IM 928292,,43.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Headache'],1,PFIZER\BIONTECH,IM 928301,,49.0,M,"SkinRash Sore arm Narrative: Redness about the size of a quarter on left hand, sore arm day after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Erythema', 'Pain in extremity', 'Rash']",1,PFIZER\BIONTECH,IM 928311,,36.0,F,"UrticariaPruritus Mild throat constriction, peri-orbital swelling Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Periorbital swelling', 'Pruritus', 'Throat tightness', 'Urticaria']",1,MODERNA,IM 928321,,30.0,F,"Narrative: Pt treated with Mehtylprednisolone 125mg IV, Diphenhydramine 50mg IV, Famotidine 20mg IV",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,['Unevaluable event'],1,MODERNA,IM 928336,,73.0,M,"Hx. DM. Noted during observation he was forgetful but able to verbalize but speech noted to slur, Juice given 120/90, 78, 18. c/o of tightness in chest and was transported to ED for evaluation in stable condition. 140/78, 68, 18. Acu chceck 240 in ED. Di Narrative: After vaccine, during observation seemed forgetful but able to verbalize. Speech noted to slur, History of DM verbalized by pt. Juice given 120/90, 78, 18. c/o of tightness in chest and was transported to ED for evaluation in stable condition. 140/78, 68, 18. Acu chceck 240 in ED. Discharged asymptomatic from ED to f/u with PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/18/2020,0.0,OTH,,,,,,"['Blood glucose increased', 'Chest discomfort', 'Dysarthria', 'Memory impairment']",1,PFIZER\BIONTECH,IM 928345,,31.0,F,Headache Narrative: Mild headache started 2 minutes after injection,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,['Headache'],1,PFIZER\BIONTECH,IM 928356,,61.0,F,Dizziness Narrative: Dizzy 10 minutes after injection,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 928371,,36.0,F,Dizziness Narrative: Dizzy approximately 2-3 minutes after vaccine injection,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 928381,,62.0,F,Injection site soreness Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,['Injection site pain'],1,PFIZER\BIONTECH,IM 928708,,49.0,F,erythema and itch at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,OTH,,,,,,"['Injection site erythema', 'Injection site pruritus']",UNK,MODERNA, 928714,,48.0,F,"Headache, Myalgia, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia']",1,MODERNA,IM 929253,,35.0,M,"Headache, Myalgia, Fever, Pain at injection site; then 1/5/2021, headache, weakness, fever; resolving today",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,"yes, pain at site with Flu shot",,"['Asthenia', 'Headache', 'Injection site pain', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 929289,,37.0,F,NauseaVomiting severe back pain that causes nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/06/2021,6.0,OTH,,,,,,"['Back pain', 'Nausea', 'Vomiting']",1,MODERNA,SC 930325,,30.0,F,"Headache fatigue, pain at injection site, mental fog",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Fatigue', 'Feeling abnormal', 'Headache', 'Injection site pain']",1,PFIZER\BIONTECH,IM 930369,,46.0,F,"Headache, Myalgia, Arthralgia, NauseaVomiting, chills/ pain inj site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,"yes flu vac tender at site, chills,body aches",,"['Arthralgia', 'Chills', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 930387,,55.0,F,"Myalgia, NausaVomiting, injection site pain Narrative: Reports severe body aches 13-72 hours following the vaccine, severe nausea, fatigue for 7 days, injection site pain for 7 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Fatigue', 'Injection site pain', 'Myalgia', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,IM 930401,,41.0,F,"Headache, Myalgia, sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/31/2020,3.0,OTH,,,,,,"['Headache', 'Myalgia', 'Oropharyngeal pain']",UNK,MODERNA,IM 930409,,52.0,M,Diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/03/2021,4.0,OTH,,,,,,['Diarrhoea'],1,MODERNA,IM 930429,,67.0,M,"Myalgia, NauseaVomiting, WEAKNESS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Asthenia', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 930435,,65.0,F,"Dizziness, Headache, NauseaVomiting, terrible vertigo 2 days after vaccine, also very nauseated Narrative: Did not have to seek any medical attention, symptoms began to resolve after 3 days, but was off of work for a day. Mostly recovered, just slight vertigo.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,"yes-used to feel sick after taking Influenza vaccine w/preservatives, now takes preservative free and has no side effects.",,"['Dizziness', 'Headache', 'Impaired work ability', 'Nausea', 'Vertigo', 'Vomiting']",1,PFIZER\BIONTECH,IM 930436,,28.0,F,"Headache, Myalgia & Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,MIL,,,,,,"['Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 930437,,40.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 930438,,42.0,F,Myalgia fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,MIL,,,,,,"['Fatigue', 'Myalgia']",UNK,MODERNA, 930439,,40.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 931854,,65.0,M,"Inflammation, erythema 2 x 3 cm area of injection visit site r upper arm. Will see his PCP today for evaluation",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,01/04/2021,13.0,MIL,,,,,,"['Injection site erythema', 'Injection site inflammation']",1,MODERNA,IM 931855,,56.0,F,SkinRash & UrticarriaPruritus,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,OTH,,,,,,"['Pruritus', 'Rash', 'Urticaria']",1,MODERNA,SC 931856,,47.0,F,"required intervention- acetaminophen and ""Nyquil"" taken",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,MIL,,,,,,['Unevaluable event'],1,MODERNA,IM 932148,,51.0,M,"Fever temp 99.7 in Occ Health, tired",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Fatigue', 'Pyrexia']",1,MODERNA,SC 932149,,41.0,F,Dizziness & NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Dizziness', 'Nausea', 'Vomiting']",1,MODERNA,IM 932150,,61.0,M,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Headache'],1,MODERNA,IM 932151,,44.0,F,influenza-like illness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,['Influenza like illness'],1,MODERNA,IM 932152,,45.0,M,Fever aching,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,MIL,,,,,,"['Pain', 'Pyrexia']",1,MODERNA,SC 932153,,33.0,F,Fever & NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 932154,,47.0,F,"Dizziness, Headache, Diarrhea, NauseaVomiting & Tachycardia acetaminophen for h/a . symptoms still occurring today",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Diarrhoea', 'Dizziness', 'Headache', 'Nausea', 'Tachycardia', 'Vomiting']",1,MODERNA,IM 932155,,58.0,M,"Headache, Myalgia, NauseaVomiting, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 932156,,54.0,F,Arthralgia Pain and swelling at injection site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,OTH,,,,,,"['Arthralgia', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 932157,,62.0,M,"Diarrhea, NauseaVomiting, chills, malaise, myalgia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,"""sore arm""",,"['Chills', 'Diarrhoea', 'Malaise', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 932158,,64.0,M,"Dizziness, Headache & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,MIL,,,,,,"['Dizziness', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 932159,,36.0,M,"Headache, Fever, Diarrhea & NauseaVomiting Narrative: Did not require medical attention. States 1/3/21 was the worse of it all. Today, 1/5/21, no longer having the side effects, however, taking Tylenol and temp is 99F and has slight headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,OTH,,,,,,"['Diarrhoea', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 932160,,44.0,M,"nausea, fatigue, disorientation",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Disorientation', 'Fatigue', 'Nausea']",1,PFIZER\BIONTECH,IM 932170,,65.0,F,"Headache, Myalgia & Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,01/04/2021,,OTH,,,,,,"['Headache', 'Myalgia', 'Pyrexia']",UNK,MODERNA,IM 932177,,59.0,F,UrticariaPruritus,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 932183,,47.0,M,"UrticariaPruritus blistering of hands self report, no medical evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,01/01/2021,10.0,OTH,,,,,,"['Blister', 'Pruritus', 'Urticaria']",1,MODERNA, 932188,,42.0,F,"Headache, Myalgia, fatigue,golfball size reddness at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Injection site erythema', 'Myalgia']",1,PFIZER\BIONTECH,IM 932190,,42.0,F,"Headache, NauseaVomiting, body aches and cramps",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,MIL,,,,,,"['Headache', 'Muscle spasms', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,IM 932191,,39.0,F,"Erythema, itching and swelling wheal",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,OTH,,,,,,"['Erythema', 'Pruritus', 'Swelling', 'Urticaria']",1,PFIZER\BIONTECH,IM 932192,,35.0,F,"ErythemaMultiform Pop can size redness at injection Grown in size pain, warmth",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Erythema multiforme', 'Injection site erythema', 'Injection site pain', 'Injection site warmth']",UNK,MODERNA, 932193,,60.0,M,Rash,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/04/2021,,OTH,,,,,,['Rash'],1,MODERNA,IM 932196,,30.0,F,"Began experiencing her lip quivering on the right side of her mouth, specifically her lower lip, also the gums underneath where her lip is quivering feels numb. Just feels the sensation, but states her lips/face are symmetrical.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/05/2021,14.0,MIL,,,,,,"['Facial spasm', 'Hypoaesthesia oral']",1,PFIZER\BIONTECH,IM 932213,,29.0,F,"Headache fatigue, sore arm,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Pain in extremity']",1,MODERNA,IM 932216,,38.0,F,"NauseaVomiting fatigue, tingling Narrative: Dentist with tingling down left arm into 5th digit-started Jan 4. Before that she has left arm pain, fatigue. Nausea and fatigue has resolved. Still has tingling down arm-complains of left neck stiffness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Fatigue', 'Musculoskeletal stiffness', 'Nausea', 'Paraesthesia', 'Vomiting']",1,MODERNA,IM 932220,,62.0,F,"Myalgia, Fever, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Fatigue', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 932222,,66.0,M,Myalgia chills Narrative: reported chills and muscle aches for 48 hours following vaccine administration,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Chills', 'Myalgia']",1,MODERNA,IM 932226,,53.0,F,"Dizziness, Headache & Nausea Vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Dizziness', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 932229,,51.0,F,"Headache insomnia, chest tightness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chest discomfort', 'Headache', 'Insomnia']",UNK,MODERNA, 932231,,44.0,F,Tachycardia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,['Tachycardia'],1,MODERNA,IM 932232,,34.0,F,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 932233,,61.0,F,"Headache, Myalgia, muscle spasms, generalized weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Asthenia', 'Headache', 'Muscle spasms', 'Myalgia']",1,MODERNA,IM 932234,,58.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,['Headache'],UNK,MODERNA, 932235,,55.0,F,"Myalgia, Arthralgia, Rash, ErythemaMultiform & NauseaVomiting Narrative: required alt ibuprofen and acetaminophen and rash appeared with hives on 1/2/2021 and Benadryl was needed",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Arthralgia', 'Erythema multiforme', 'Myalgia', 'Nausea', 'Rash', 'Urticaria', 'Vomiting']",1,MODERNA,IM 932236,,53.0,F,Has reported history of anaphylaxis to aspirin. Symptoms have started to resolve at this time with use of acetaminophen,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,OTH,,,,,,['Ill-defined disorder'],1,MODERNA,ID 932237,,63.0,M,"some mild ""itching""in throat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Throat irritation'],UNK,MODERNA, 932239,,61.0,F,Myalgia & Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/04/2021,,OTH,,,,,,"['Myalgia', 'Pyrexia']",1,MODERNA,IM 932240,,55.0,F,Headache Burning bilateral eyes,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/06/2021,2.0,OTH,,,,,,"['Eye irritation', 'Headache']",1,MODERNA,IM 932241,,59.0,F,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA, 932242,,57.0,F,Dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 932243,,37.0,F,"Left Upper Extremity Numbness Narrative: 1- My left arm (arm I received the vaccine in) got pins and needles feeling in it about 1 hour post vaccine, and it continued through the evening as well as in my legs, forehead, and upper cheeks on my face. Best way to explain it is that feeling you get when your arm falls asleep and is waking up. I've spoke to a few others who had similar feeling in their vaccine arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 932244,,46.0,M,"Headache, Myalgia, Fever, fever, chills, sweating, back pain, pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Back pain', 'Chills', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Pain', 'Pyrexia']",1,MODERNA,SC 932245,,42.0,F,Headache Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,,,,['Headache'],1,PFIZER\BIONTECH,IM 932246,,54.0,F,Headache & Myalgia Narrative: required intervention with ibuprofen 400mg,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 932247,,36.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2020,12/29/2020,335.0,OTH,,,,,,['Headache'],UNK,MODERNA, 932248,,36.0,F,"employee reports painful and swollen lymph nodes in armpit, axillary lymphadenopathy radiating down to arm of injection site 5 days post vaccination administration. employee took tylenol BID, adverse event lasted 2-3 days and resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/28/2020,5.0,OTH,,,,,,"['Injection site lymphadenopathy', 'Lymph node pain', 'Lymphadenopathy']",UNK,MODERNA, 932249,,53.0,F,"Headache, Myalgia, Fever & NauseaVomiting Narrative: Employee missed 2 days of work due to chills, headache, nausea, vomiting and temperature up to 100.7. Currently has headache. Plans to return to work tomorrow.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 932250,,36.0,F,"Headache, Myalgia, chills required treatment with topical ""biofreeze"", acetaminophen 650mg and ibuprofen 400mg",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia']",1,MODERNA,IM 932251,,45.0,M,"injection site reaction, redness and itching",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/23/2020,,OTH,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site reaction']",1,MODERNA,IM 932252,,46.0,F,"SkinRash, Rash, sevdere fatigue and facial hives",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Fatigue', 'Rash', 'Urticaria']",UNK,PFIZER\BIONTECH,IM 932253,,56.0,F,"Headache, Myalgia, Tachycardia, Significant chills also reported. Required employee to be away from work, reported greater than 16 hours of sleep second to the overwhelming fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Hypersomnia', 'Impaired work ability', 'Myalgia', 'Tachycardia']",2,PFIZER\BIONTECH,IM 932254,,57.0,M,Arthralgia & Fever Narrative: required acetaminophen for temp control,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Arthralgia', 'Pyrexia']",1,MODERNA,IM 932255,,52.0,F,"arm pain, flulike symptoms, flushes Narrative: required intervention of ibuprofen 400mg and ""Zyrtec-D""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Flushing', 'Influenza like illness', 'Pain in extremity']",1,MODERNA,IM 932257,,50.0,F,Arthralgia,Not Reported,,Not Reported,Not Reported,,Not Reported,N,11/16/2020,12/18/2020,32.0,OTH,,,,,,['Arthralgia'],1,PFIZER\BIONTECH,IM 932258,,53.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Headache'],1,PFIZER\BIONTECH,IM 932259,,60.0,F,SkinRash Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,OTH,,,,,,['Rash'],1,MODERNA, 932260,,50.0,M,Rash,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/03/2021,4.0,OTH,,,,,,['Rash'],1,PFIZER\BIONTECH,IM 932261,,55.0,M,"Dizziness, Headache, chills, fatigue, tachycardia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Tachycardia']",1,MODERNA,IM 932262,,63.0,M,The employee had COVID test on 12/28 that as positive and was asymptomatic. Subsequent COVID testing on 12/29 and 12/31 were negative. He was tested as part of routing surveillance,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/28/2020,6.0,OTH,,,,,,"['Asymptomatic COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 932263,,53.0,F,"Patient complains of redness, itching and swelling at injection site that has progressively worsened since receiving vaccine. Patient states redness and swelling have a diameter of two inches at injection site. Narrative: Patient complains of redness, itching and swelling at injection site that has progressively worsened since receiving vaccine over one week ago. Patient states there is a two inch diameter of redness and swelling at injection site and itching has worsened. Patient advised to see primary care provider if symptoms continue to worsen and do not resolve.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 932264,,38.0,F,"Headache & Rash Narrative: 7-8 days after initial vaccination headache, pain at injection site and rash below injection site. Itching feeling. Patinet took motrin and tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/01/2021,8.0,OTH,,,,,,"['Headache', 'Injection site pain', 'Injection site rash', 'Pruritus', 'Rash']",1,MODERNA,IM 932363,,34.0,M,tingling lips and scratchy tongue Narrative: Within minutes of receiving vaccine patient reported tingling lips and tongue feeling scratchy. Administered at outpatient clinic so taken to urgent care where they were treated with Methylprednisolone Inj 125mg IPV and Diphenhydramine Inj 25mg IVP,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Paraesthesia oral', 'Tongue pruritus']",1,MODERNA,IM 932374,,38.0,M,"Headache, Myalgia, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Headache', 'Malaise', 'Myalgia']",1,MODERNA,IM 932375,,52.0,F,"Dizziness & UrticariaPruritus Hx of Guillan Barre with prior influenza vaccination. Anxious regarding hives. Transferred from observation area to ED (located within 50 feet from observation area). Treated with IV Benadryl, IV Solumedrol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,yes - Guillan Barre Syndrome following Influenza vaccination several years ago,,"['Anxiety', 'Dizziness', 'Pruritus', 'Urticaria']",UNK,MODERNA,IM 932376,,42.0,F,"Headache, ErythemaMultiform, L arm soreness, fatigue, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Chills', 'Erythema multiforme', 'Fatigue', 'Headache', 'Pain in extremity']",1,MODERNA,IM 932377,,37.0,F,"Headache, Myalgia, Fever, NauseaVomiting, ""chills, face felt swollen""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Swelling face', 'Vomiting']",1,MODERNA,IM 932378,VA,59.0,F,"Headache, Myalgia, lips tingling/12/26 had cold sore , RT ear pain went walk-in stated both eardrums bulging rt side face numbness",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Ear pain', 'Headache', 'Hypoaesthesia', 'Myalgia', 'Oral herpes', 'Paraesthesia oral']",1,MODERNA,IM 932379,,54.0,F,"c/o lightheadedness, sob for short period. resolved. stated, ""feeling weird, maybe I'm anxious."" Vitals stable, Given Juice PO. 145/89, 74, 20, 100% O2sat. D/C'd after 30 minutes in stable condition 117/67, 65, 20, 100% O2 sat..",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Anxiety', 'Dizziness', 'Dyspnoea', 'Feeling abnormal']",UNK,PFIZER\BIONTECH,IM 932380,,37.0,F,"fatigue, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/05/2021,5.0,OTH,,,,,,"['Chills', 'Fatigue']",1,MODERNA,IM 932381,,59.0,F,"Headache, Myalgia, Arthralgia, Fever, CoughWheeze & Syncope",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Arthralgia', 'Cough', 'Headache', 'Myalgia', 'Pyrexia', 'Syncope', 'Wheezing']",1,MODERNA,IM 932382,,65.0,F,"Dizziness states tired after working 12 hour night shift. Recovered after juice and water. Narrative: c/o dizziness after vaccine given following working a 12 hour night shift. States, ""tired after shift"". Given orange juice and water. Recovered. d/c stable 130/81, 79, 18, o2 sat %.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 932383,,1.08,F,"NauseaVomiting History of vasovagal episodes; c/o warm feeling and nausea without vomiting. Recovered Narrative: 10 minutes after vaccine admin. c/o/ warmth and nausea. Triaged by the ER nurse and observed for 45 minutes. Discharged in stable condition 133/84, 104, 18",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Feeling hot', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 932384,,57.0,F,"Myalgia Per patient: ""started haveing sinus drainage and muscle aches 2 days after and still going on no temperature, no diarrhea or loss of taste or smell"" Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/29/2020,,OTH,,,,,,"['Myalgia', 'Paranasal sinus hypersecretion']",1,MODERNA,IM 932385,,70.0,F,"Headache Received shot at around noon - felt really tired/fatigued/""wilty"" worn out hours later that afternoon which lasted for the next 3 days. Woke up with moderate headache next morning, if had to work that day, would not have been able to.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Fatigue', 'Feeling abnormal', 'Headache', 'Impaired work ability']",1,MODERNA,IM 932386,,53.0,M,Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/04/2021,6.0,OTH,,,,,,['Pyrexia'],UNK,MODERNA, 932387,,40.0,F,Headache & UrticariaPruritus,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/05/2021,5.0,OTH,,,,,,"['Headache', 'Pruritus', 'Urticaria']",UNK,MODERNA, 932388,,44.0,F,Mild tingling and numbness symptoms started on her right side of face then later radiating to right arm and right lower extremity. Denies any weakness Narrative: will be seeing her PCP,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 932389,,42.0,F,"Headache, Myalgia, NauseaVomiting, chills, pain at injection site Narrative: will report to work",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Chills', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 932390,,38.0,F,Fatigue and injection site soreness. Narrative: Patient awakened this AM with injection site soreness and fatigue. She did not come to work today stating she felt too tired,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Fatigue', 'Impaired work ability', 'Injection site pain']",1,PFIZER\BIONTECH,IM 932391,,68.0,F,"Rash erythema, warmth, and itchiness to site of injection Narrative: erythema, warmth, and itchiness to site of injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/31/2020,,OTH,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,MODERNA,IM 932392,,46.0,F,"UrticariaPruritus Narrative: 0933 PT STATES SHE FELT ""ITCHY""/ VS- 133/89; P-93; SAT 98%; TEMP 98.3. 0957 PT STATES NOW ITCHING TO PALATE; FEELS ""SWOLLEN""; NO NOTED OBSTRUCTION TO AIRWAY NOTED; EMS CALLED; 1015 PT DECLINED TRANSPORT TO ER VIA EMS; REMAINS STABLE; SAT 98%; DENIES DIFFICULTY BREATHING. 1035- BENADRYL 25MG PO ONCE ORDERED BY DR, AND GIVEN BY RN. VSS; P-74; R-16; SAT-99%; BP-133/79; TEMP-98.6;PT ABULATED TO OFFICE; HUSBAND TO DRIVE PT HOME LATER TODAY.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Oral pruritus', 'Pruritus', 'Swelling', 'Urticaria']",1,PFIZER\BIONTECH,IM 932393,,65.0,M,"Angina Hx. of HTN, DM, pacemaker presented with CP that radiated to bilateral jaw/chin. VSS. Narrative: After covid19 vaccination, c/o CP with radiation to jaw/chin. denied SOB, nausea or diaphoresis. Monitored for 30 minutes with CP resolved but jaw/chin sensation remained. Brought to ED at 15:25 in stable condition. . In ED, stable vitals, a-paced rhythm w/o ST changes per ED note. Offered OBS admission for further cardiac workup but patient declined and was discharged in stable condition with no CP or jaw/chin sensations present.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,OTH,,,,,,"['Chest pain', 'Pain', 'Pain in jaw']",1,PFIZER\BIONTECH,IM 932394,,34.0,F,Sedation Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,['Sedation'],UNK,MODERNA, 932395,,45.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/29/2020,,OTH,,,,,,['Myalgia'],1,PFIZER\BIONTECH,IM 932396,,51.0,F,"c/o lightheadedness and light headache. Cold pack applied to nape of neck, head down, felt better and returned to work Narrative: c/o lightheadedness and mild headache. resolved and returned to work",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,OTH,,,,,,"['Dizziness', 'Headache']",1,PFIZER\BIONTECH,IM 932399,,49.0,F,"UrticariaPruritus HOT flashes, prickly skin of jaw line to chest EMP was injected in the ER due to a previous flu vax reaction 2 years. She did consequently have a migraine headache upon awakening this AM which prevented her from working. Treated with Benadryl 25mg PO in the ER, monitored via cardiac monitor and then she was discharged with 25mg of Benadryl that she took when she got home at 1630.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,MIL,,,,"yes, had hot prickly skin",,"['Cardiac monitoring', 'Hot flush', 'Impaired work ability', 'Migraine', 'Paraesthesia', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 932401,,31.0,F,"Myalgia, Fever, CHILLS Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pyrexia']",UNK,MODERNA, 932402,,45.0,F,"Headache, Myalgia, fatigue, stomach ache Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Abdominal pain upper', 'Fatigue', 'Headache', 'Myalgia']",UNK,MODERNA, 933628,,26.0,F,"Myalgia, Fever, LYMPHADENOPATHY",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/27/2020,3.0,OTH,,,,,,"['Lymphadenopathy', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 933633,,57.0,F,"Headache, Myalgia, bodyache;chills;ha;sorethroat;nasal congestion Narrative: day 1-5: bodyache;chills 12/31: ha 1/3:ha; chills; sorethroat;nasal congestion",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Nasal congestion', 'Oropharyngeal pain', 'Pain']",1,MODERNA,IM 933639,,53.0,F,"Headache, Myalgia & Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pyrexia']",UNK,MODERNA,IM 933646,,51.0,F,"Headache, NauseaVomiting, FATIGUE Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/03/2021,3.0,OTH,,,,,,"['Fatigue', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 933649,,41.0,F,5 INCH CIRCL SIZE REDNESS AT INJECTION SITE; ITCHY,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/05/2021,5.0,OTH,,,,,,"['Injection site erythema', 'Injection site pruritus']",UNK,MODERNA, 933658,,41.0,F,"1/3/21: SWOLLEN, SORE LYMPH NODES TO LEFT AXILLA, INJECTION SITE ITCING, SWELLING, WARMTH, REDNESS & department visit TENDERNESS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/03/2021,6.0,UNK,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 933663,,43.0,F,"thrombocytopenia, bleeding gums, bruised eyelids Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Eyelid disorder', 'Gingival bleeding', 'Thrombocytopenia']",1,MODERNA,IM 933669,,53.0,F,"Myalgia, Fever, ErythemaMultiform, pharyngitis Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Erythema multiforme', 'Myalgia', 'Pharyngitis', 'Pyrexia']",1,MODERNA,IM 933675,,41.0,F,"Headache Per nursing: ""took Moderna on last Thursday on January 31st,2020. C/o migraine headache on Friday morning. States had sore throat and sore tongue since before taking the vaccine but states feels like it's getting worse. Employee also c/o feels like her to Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Glossodynia', 'Headache', 'Oropharyngeal pain']",1,MODERNA,IM 933682,,46.0,F,"Headache, Myalgia, Fever, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 933686,,62.0,M,rib pain/shortness breath/Pulmonary Embolus and viral pneumonia Narrative: Development of symptoms beyond the 48-72 window. Tested at time of ER visit Negative for Covid. Repeated Covid NP swab on 01/05/2021. Was not hospitalized overnight discharge home on oral anticoagulant medications.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/29/2020,6.0,OTH,,,,,,"['Dyspnoea', 'Musculoskeletal chest pain', 'Pneumonia viral', 'Pulmonary embolism', 'SARS-CoV-2 test negative']",1,MODERNA,IM 933691,,45.0,F,"SkinRash, Rash, 5cm round red non-raised area. Slightly warm to touch. Denies itching Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/04/2021,11.0,OTH,,,,,,"['Rash', 'Rash erythematous', 'Skin warm']",1,MODERNA,IM 933697,,70.0,F,"Myalgia, Fever & ErythemaMultiform Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Erythema multiforme', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 933741,,44.0,F,"Headache, Myalgia, Arthralgia, Fever, Rash & NauseaVomiting Narrative: required to remain out of work and still having arm soreness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/31/2020,,OTH,,,,,,"['Arthralgia', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Rash', 'Vomiting']",1,MODERNA,IM 924783,WA,55.0,F,"A week after shot, developed a red, raised, indurated warmer 2 in x2 in area in the area of the injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,none,none,none,,food allergies,"['Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 924784,MI,57.0,F,"WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WIT SCRATCHY THROAT AND RED NCK AND CHIN. THEATED WITH BENADRYL AND DECADRON FROM THE ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,"DIPROSOME CREAM, WELLBUTRIN SR",NO,DEPRESSION,,"CHOCHOLATE, MILK, STATINS, TETRACYCLINES","['Erythema', 'Feeling hot', 'Heart rate abnormal', 'Nausea', 'Oropharyngeal discomfort']",1,PFIZER\BIONTECH,IM 924785,AK,84.0,F,Patient felt faint/lightheaded. Blood pressure decreased to 96/60. It quickly rebounded and she returned to baseline within 15 minutes.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,SEN,"Combivent, Bacid, aspirin, Buspar, calcium-vitamin D, Coreg, Colace, Airduo, Lasix, gabapentin","CHF, Pharyngoesphageal dysphagia","Hypertension, PEG tube",,Sulfadiazine,"['Blood pressure decreased', 'Dizziness', 'Syncope']",1,PFIZER\BIONTECH,IM 924786,NV,40.0,F,"Headache, chills, body-ache, fever, nausea, vomiting, and weakness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,WRK,Tylenol MVI,GERD HTN,GERD HTN,,Morphine Lisinopril Metformin,"['Asthenia', 'Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 924787,MI,45.0,F,"CLAMMY SKIN , LABORED BREATHING , DRY COUGH, TREATED WITH BENADRLT . SENT TO ER, PLACED ON DECADRON.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/03/2021,2.0,PVT,"STNTHROID,TOPROL XL,",NO,"HYOPOTHROIDISM,",,"CLINDAMYCIN. MORPHINE, SULFA","['Cold sweat', 'Dyspnoea']",1,PFIZER\BIONTECH,IM 924788,HI,24.0,F,"Patient was complaining of vertigo at 11:05 am after vaccination about 10 minutes after; BP:106/60, P:72, R:22, O2:99% Reclined back in seat, gave snack/water, was better when patient closed her eyes. At 11;15, tried to move her outside of car to cot, was unable to move because was too dizzy. Was assessed by Dr., and vertigo got worse with position change and was seeing spots. Hx of migraines about every 3 months. By half an hour after her vaccination, she was unable to move, so family was called to pick her up from clinic. Advised to follow up with PCP today and discuss decision about dose #2.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,Unknown,None,None,,None,"['Dizziness', 'Movement disorder', 'Vertigo', 'Visual impairment']",1,MODERNA,IM 924789,NV,40.0,F,HEADACHE FEVER CHILLS NAUSEA VOMITING WEAKNESS BODY ACHE,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,WRK,Tylenol MVI,GERD HTN NEUROPATHY,GERD HTN NEUROPATHY,,Morphine Lisinopril Metformin,"['Asthenia', 'Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 924790,TN,31.0,F,"Muscle aches, joint pain, fatigue, nausea, chills, fever, delirium from fever. Symptoms lasted 22 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Melatonin, multi vitamin, vitamin D",None.,None.,,"Penicillin, amoxicillin, Tagamet, biaxin, omnicef, crab","['Arthralgia', 'Chills', 'Delirium', 'Fatigue', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH, 924791,MA,40.0,F,Day 8- arm tender and painful/flu like symptoms of feverish and body aches. Bad backache and neck pain. Day 9- arm with redness; hot; painful; swollen. dull headache and neck ache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,WRK,"Zyrtec, Magnesium, Advair, Singulair, Nasacort, Olopatadine",,Asthma and Allergies,,"Sulfa, Avocado, Pinapple, Shell Fish, Almonds, Hazelnut, Brazillian Nut, Eggs,","['Erythema', 'Headache', 'Influenza like illness', 'Neck pain', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Pyrexia', 'Skin warm', 'Tenderness']",1,MODERNA,SYR 924792,TX,60.0,F,"1/6/21 - 3pm. Experiencing chills, headache, heart rate at 103/min sitting. - 10:06 pm, chills, headache, fever 99.6 - 10:38 pm, chills headache, fever 100.1 - 11:05pm, chills headache, fever 101.5 -",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,None,None,I have used a CPAP for 12 years.,,"Latex, penicillin, codeine","['Chills', 'Headache', 'Pyrexia', 'Tachycardia']",1,PFIZER\BIONTECH,IM 924793,CO,32.0,F,"Arm was sore at injection site first two days; similar to when you get flu shot but about 3x worse ( was hard to lift arm). At got better and was normal by day 3. Today, 7 days from day of injection, I woke up with my left arm (injection side) sore and inflamed, arm was warm to touch and hurt when I pushed. There's a mass of dense/sore area, sort of feels like a dense lump. Area around on skin is itchy - has been this way all day. Tonight the swollenness and itchiness is traveling into left armpit as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PUB,none,none,none,,allergic to kiwis and mussles (as in shellfish but not all shellfish just mussles),"['Injected limb mobility decreased', 'Injection site inflammation', 'Injection site mass', 'Injection site pain', 'Injection site pruritus', 'Oedema peripheral', 'Pruritus', 'Skin warm']",1,MODERNA,SYR 924794,WA,35.0,F,"At 8:35 AM Pacific Time on 1/6/2021, I removed my long-sleeve shirt and noticed redness and swelling on my upper left arm. This is the site where I received my first dose of the COVID19 (Moderna) vaccine. This is the first time seeing any redness and swelling on the injection site. Before experiencing redness, swelling and slight warm feeling on my upper left arm, I only experienced mild pain and soreness. Mild pain and soreness went away on 1/5/2021. In addition to redness and swelling, my upper left arm feels slightly warm. After taking a shower, I made sure to not put any lotion on my upper left arm. I got dressed, and I took one tablet of Diphenhydramine HCl 25 mg to help reduce redness and swelling. I went to bed at approximately 10:50 AM. I woke up at approximately 6:50 PM and checked my upper left arm. The redness and swelling went down on my upper left arm, but it still feels slightly warm. I will continue to monitor it for the next several days.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/06/2021,8.0,PVT,"Acetaminophen 500 mg, Losartan Potassium 100 mg, Vitamin D, Vitamin C, Fish Oil",None,"Hypertension, Obesity",,Amlodipine,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA, 924795,KS,61.0,M,Sore shoulder progressing to bilateral neck and headache over the course of the day 1/6/21,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,Losartan/hctz Loratidine Aspirin,None,HTN,,IV iodine,"['Arthralgia', 'Headache', 'Neck pain']",2,PFIZER\BIONTECH,IM 924796,NE,46.0,F,"Moderate body aches, fatigue, headache, low grade fever. Lasted about 18 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,"Otc ibuprofen, hydrochlorothiazide",None,Hypertension,,Penicillin,"['Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 924797,IL,45.0,M,"Got fever on 2nd January morning, fever was there continuously till 3rd January. Fever varies 101.3 to 101.5 degree F Took Tylenol twice a day 12 hrs interval (1000 mg/ dose) 4th January morning onwards there is no fever Still I feel Chills, Fatigue and muscle pain moderately exist. My PCP (Dr.) and her nurse denied to schedule appointment in person on 01-06-2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,SCH,None,NONE,NONE,,None or not known,"['Chills', 'Fatigue', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 924800,,42.0,F,Wheezing Rapid breathing Throat itching and tightness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,Losartan hctz,Cough-took steroids for it until three days before vaccination,HTN,,Cytotec Bactrim,"['Respiratory rate increased', 'Throat irritation', 'Throat tightness', 'Wheezing']",UNK,PFIZER\BIONTECH,IM 924801,WA,35.0,F,"At 8:35 AM on 1/6/2021, I noticed redness and swelling on my upper left arm as I removed my long-sleeve shirt. I also noticed that my upper left arm was slightly warm after touching it. This is the first time I have experienced redness, swelling and warmth on the injection site. After I got my first dose of the COVID19 (Moderna) vaccine, I experienced mild pain, soreness and muscular/body aches for several days. I longer experienced these particular symptoms on 1/5/2021. To treat the redness and swelling, I took one 25 mg tablet of Diphenhydramine HCl at approximately 10:00 AM. I went to bed 50 minutes later. I woke up at approximately 6:50 PM. I checked my upper left arm and saw that the redness and swelling went down. However, my upper left arm still feels slightly warm. I will continue to monitor my current symptoms for the next few days.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/06/2021,8.0,PVT,"Acetaminophen 500 mg tablets, Losartan Potassium 100 mg tablet (taken by mouth once a day), Vitamin D supplement, Vitamin C supplement, Fish Oil supplement",NONE,"Hypertension, Obesity",,Amlodipine,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Myalgia', 'Pain']",1,MODERNA,IM 924802,TX,28.0,F,Significant arm soreness and generalized body aches about 9-10 hours after the vaccine. Lasted about 24 hours and prevented me from performing daily activities or working.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Oral contraceptive pills, biotin and vitamin D supplements",None,None,,None,"['Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 924803,OR,49.0,F,Developed red welt (hive like) at site if injection 9 days after receiving the vaccine. Rash is raised and approx 3X2 inches. It itches and warm to the touch but not painful. I do not have a fever or any other adverse reactions at this time. When I 1st received the vaccine I had pain at the injection site and up/down the arm for approximately 48 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,01/06/2021,36.0,PVT,"Vitamin C, Vitamin D3, Zinc and Apple Cider Vinegar gummies",None,None,,No known allergies,"['Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site urticaria', 'Injection site warmth']",1,MODERNA,IM 924804,NC,32.0,F,Started heavy period within 4 hours of vaccination. Period isn?t due for 3 more week.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,SEN,None,None,None,,None,['Menorrhagia'],1,MODERNA,IM 924805,AK,39.0,F,Pt was administered Moderna Covid-19 Vaccine EUA at a Covid Vaccination clinic. Pt experienced dizziness and shakiness and tingly lips. Pt waited at site for approx. 60 minutes and felt well enough to leave,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PHM,,,,,,"['Dizziness', 'Paraesthesia oral', 'Tremor']",1,MODERNA,IM 924806,TX,70.0,F,"pain at first, redness. Redness went away after a few days. Redness returned and expanded on arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,Estradiol Montelukast,none,colon cancer survivor,,"lobster, codeine, erythmycin","['Erythema', 'Pain']",1,MODERNA,SYR 924807,KY,49.0,F,Anaphylactic reaction,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Multi vitamin, Vitamin D, Claritin",None,None,,"Penicillin, sulfa, morphine, codeine, lortab, Percocet, shellfish and nuts",['Anaphylactic reaction'],1,PFIZER\BIONTECH,SYR 924808,AK,22.0,F,Patient passed out about 3 minutes after Moderna Covid19 vaccine EUA administration and came to really quickly and decided to move to a chair. No difficulty breathy per paramedics but when they arrived she passed out a second time and paramedics opted to take patient to hospital for observation.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/01/2021,,PHM,,,Type 1 Diabetic,"passed out, worries about vaccines",,['Loss of consciousness'],1,MODERNA,IM 924809,DE,56.0,F,I had vaccine at 0800 on Monday morning 1/4/21 by 0100 on 1/5/21 woke up with chills and fever of 39.4 then came tremendous aches in bilateral hips and legs; migraine headache; had fever most of the day; also nauseous unable to eat,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,none,no illness at the time of vaccination and up to one month prior,none,,no drug allergies ( possible agave food allergy,"['Arthralgia', 'Chills', 'Migraine', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 924810,AK,61.0,F,Patient 3/19/1959 started to feel dizzy and nauseated after her Moderna Covid 19 immunization. Had patient sit for extended observation. Started feeling better around 10pm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PHM,Patient 3/19/1959 started to feel dizzy and nauseated after her Moderna Covid 19 immunization. Started to feel a bit better by 10pm.,,,,,"['Dizziness', 'Nausea']",1,MODERNA,IM 924811,OH,52.0,M,"Moderate pain at injection site immediately after injection. This spread to involve pain throughout the posterior upper arm for about 6 days before resolving. Did get moderate relief with use of ibuprofen 600 mg PO Q 8 hrs PRN. Received vaccine on 12/23/20 at 6pm. Woke up at 5am to go to work on 12/24/20 and felt flu-like symptoms with subjective fever (did not measure), joint pain, and diffuse myalgias. Symptoms progressed over the next three hours and culminated in about half an hour of significant rigors with uncontrolled shivering. Ibuprofen dose of 600mg orally did help symptoms enough to allow me to finish my shift but I needed two more doses every 8 hours before symptoms resolved in 24 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,WRK,,,,,,"['Arthralgia', 'Chills', 'Influenza like illness', 'Injection site pain', 'Myalgia', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA,IM 924812,,27.0,F,"Roughly 10 hours after receiving 2nd dose of the vaccine, woke with chills and severe body aches. Took 400 mg ibuprofen and put on additional layers and was eventually able to sleep for a couple more hours. Chills improved during mid-day, but body aches remained. Approaching 22-24 hours post vaccine, chills and body aches worsened. Took oral temperature in the evening which read 100.5 F. Took additional 400 mg ibuprofen and fluctuated between hot and cold for the rest of the evening. Awoke the next day(~36 hours post dose) and fever was gone but mild chills and body aches remained. Symptoms virtually gone by early afternoon (slightly before 48 hours after dose).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Oral contraceptive,None,None,,No known allergies,"['Chills', 'Pain']",2,PFIZER\BIONTECH,IM 924813,TX,25.0,F,"Fever, severe myalgia, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Yaz birth control,Nond,None,,None,"['Chills', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924814,AK,49.0,M,"Had a slight headache a few hours after the injection, three hours later felt tired and headache worsened but improved with 500mg Tylenol. That night fatigue got worse but headache improved. Went to bed at 9pm and had severe chills and shaking, heart was beating fast. Chills lasted for several hours. Increased heart rate all night and could not sleep at all. Fitful night sleep and started to sweat in the Early morning. Woke up for work at 5:30 am and had headache, dizziness, and flu-like symptoms with joint and muscle aches. Had sweats all day today. Went home early from work and slept from 9:30 am to 4:30 pm. Most symptoms improved now but feel like I still have a fever and sweats.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Heart rate increased', 'Tremor']",2,PFIZER\BIONTECH,SYR 924815,NC,20.0,M,"Side effects included fever and chills about 24 hours after the shot. In general, I felt like you would when an individual is in early flu stages. Fever was 100.2 and chills progressed throughout the night.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,WRK,Cholestipol,,Short Bowel Syndrome,,,"['Chills', 'Pyrexia']",1,MODERNA,IM 924816,CA,60.0,F,"intensely pruritic rash, starting around neck initially and then presenting in perianal area, moving up lower back with sharp linear demarcations, also perinasal bilat . Also on eyelid with periorbital edema rt>lt. Typical appearance of contact derm with raised indurated intensely pruritic lesion except almost exact opposite in distribution (flexoral/internal aspects of skin) and no known exposures. Now day two and rash is becoming more well demarcated, more red and inflamed and spreading in distribution face, neck and lower back. There is no logical explanation for this rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/05/2021,12.0,PVT,Nortriptyline 10 mg q hs MVI,none,ho RAD mild,,nka,"['Dermatitis', 'Dermatitis contact', 'Erythema', 'Periorbital oedema', 'Rash pruritic', 'SARS-CoV-2 test negative', 'Skin induration']",1,PFIZER\BIONTECH,IM 924817,TX,32.0,F,"As soon as I received my shot it was like an electric shot from the injection shot, up the back of my neck, into my brain. I was instantly woozy and disoriented. They moved me to observation. My hemiplegic migraine started within 10 minutes of the vaccine. I take a preventative every day, and to be honest after the vaccine it was like I had never, ever taken my preventatives. The migraine I got that day is the worst one I have experienced since the first one I ever got. Now on top of the migraines, the vaccine gave me waves of new symptoms. I was having spells of intense heat flashes, with wooziness, and nausea. So the new symptoms were paired with the hemiplegic migraines that, if you aren?t familiar with, mimic strokes because my whole left side tends to go limp, and I struggle with speech, and cognitive issues. So it really wasn?t all too long before the nurse kindly suggested that I didn?t look great and we should head to the ED. They treated the migraine, gave me a CT, everything came back fine. They reached out to my neurologist, gave me some fluids, really they wanted to keep me a little longer, but I know the migraine drill and just wanted to go home and sleep and eat. I promised to follow up with my neurologist and fill out my CDC form. Over the next week the migraine and extra symptoms seemed to slowly but surely let up. The only note worthy thing was really that my left side would get extra tender at times. Not just my injection site, but it was almost like all my nerve endings all over my left side were on fire at times and a pinch on the thigh may as well have been a stab, or a pat on the back a punch. It was pretty intense at times. And just when I thought it was all over my menses started, you see my hormones trigger my migraines. And once again it was like I wasn?t on a preventative. I had an intense Migraine start. I was able to take my bail out medication (sumatriptan) though and get to work. I moved forward with my day, and just when I thought all was normal, I got one of those brutal heat flashes, the room started moving, and I was nauseous. Unfortunately I was in full PPE, I almost passed out, I had to get a coworker to help, they had to get my supervisor. It was a big, unnecessary-necessary, pride-wounding scene. Now I am not a scientist or a doctor, but I might speculate that people with neurological deficits, like myself, are going to have a harder time with this inactive Covid strand. I would much rather be immune to Covid then catch it though, so whatever I can do to help, and protect myself and family and friends and neighbors, I will absolutely do... But I imagine there is probably an adjustment to be made here for the neurologically impaired. Thanks for your time, and let me know if you have any questions.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,WRK,Sumatriptan Bupropion topiramate Seroquil Vitamin D Iron Magnesium Vitamin C Women?s one a day B 12 Omega 3 Fiber Calcium Biotin Probiotic Sudafed,Seasonal Allergies,Hemiplegic migraine IBS Bipolar,,Dyclomine,"['Computerised tomogram', 'Disorientation', 'Dizziness', 'Hemiplegic migraine', 'Hot flush', 'Instillation site paraesthesia', 'Nausea', 'Tenderness', 'Vertigo']",1,PFIZER\BIONTECH,SYR 924818,WA,36.0,M,"Very sore arm. Started on my shoulder, moved to the rest of my left arm after I was working for about half an hour. I took two ibuprofen and it all stopped aside from soreness around the injection point. Which is still a little sore now at 11:10. I also had some dizziness around 3:30 pm (2+ hours after receiving the shot)",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,OTH,None.,None.,None.,,None.,"['Dizziness', 'Injection site pain', 'Pain in extremity']",1,MODERNA,SYR 924819,CA,39.0,F,"Rash at injection site 8 days following vaccine. Site became swollen, red and very warm to touch for 72 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,PVT,,,,,Sulfa,"['Injection site erythema', 'Injection site rash', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 924820,CO,81.0,M,"COUGH, RIGORS, NAUSEA, VOMITING, URINARY URGENCY/FREQUENCY, DYSURIA - FOUND TO HAVE LLL PNEUMONIA, CONCERNING FOR POSSIBLE CYRPTOGENIC ORGANIZING PNEUMONIA",Not Reported,,Not Reported,Yes,,Not Reported,N,12/31/2020,01/02/2021,2.0,PVT,,,,,"PENICILLIN (UNKNOWN, REMOTE REACTION)","['Chills', 'Cough', 'Dysuria', 'Micturition urgency', 'Nausea', 'Pneumonia', 'Pollakiuria', 'Vomiting']",1,MODERNA,IM 924821,PA,29.0,M,Pfizer-BioNTech COVID-19 Vaccine EUA Injection given at 1420. He was watched for 15 minutes following vaccine administration without incident. Returned endorsing dizziness and nausea at 1455. Was tachycardic with HR in 130s with elevated BP with systolic in 150s. Given hydration and vitals monitored for about 45-55 minutes. Vitals downtrended and began to normalize. Stood to leave and became diaphoretic and weak. Placed in wheelchair for transfer down the hall to the ER and became unresponsive on the way. Was given epinephrine 0.3 mg to L thigh. Given IV fluids and acetaminophen. Returned to usual state of health and was discharged home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Adderall XR, trazodone, mirtazapine",none,"ADHD, PTSD, insomnia",,"clonazepam, ambien, lorazepam","['Asthenia', 'Blood pressure increased', 'Chest X-ray normal', 'Dizziness', 'Full blood count normal', 'Hyperhidrosis', 'Laboratory test normal', 'Nausea', 'Tachycardia', 'Troponin normal', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 924822,,82.0,F,"PATIENT DEVELOPED PROGRESSIVE NEW DYSPNEA, DIFFERENT FROM HER BASELINE. SHE HAS BEEN HOSPITALIZED TWICE FOR PERSISTENT DYSPNEA AND CENTRALIZED CHEST PAIN, WHICH HAS OTHERWISE HAD NEGATIVE WORK UP.",Not Reported,,Not Reported,Yes,,Not Reported,U,12/29/2020,12/31/2020,2.0,PVT,,,,,ATIVAN METOPROLOL,"['Chest pain', 'Dyspnoea']",1,MODERNA,IM 924823,CO,35.0,F,"Severe panic attacks beginning three days after vaccination. They have continued since then, decreasing in frequency and severity but persisting still. Have discussed with my physician. I have no prior history of panic attacks. I am checking ""office visit"" under Item 21 as I have communicated via email with my physician but not been into the office.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/25/2020,4.0,WRK,"Lamictal 200mg once daily, Wellbutrin XL 150mg once daily, multivitamin daily and other supplements PRN.",None,"Allergies, depression",,"Allergic to peanuts, walnuts, beef, penicillins",['Panic attack'],1,PFIZER\BIONTECH,IM 924824,NE,50.0,F,"Abdominal bloating, nausea, vomiting, abdominal pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,UNK,"Multivitamins, ativan, levithyroxine, calcium, escatalopram",None,"Obesity, asthma, hypothyroidism, anxiety, hx depression",,None,"['Abdominal distension', 'Abdominal pain', 'Nausea', 'SARS-CoV-2 test negative', 'Vomiting']",1,MODERNA,SYR 924825,MN,33.0,M,"I literally feel the worst I have ever felt in my life. Profusely sweating, whole body hurts, practically can?t move my left wrist hurts so bad and insomnia. I feel like a sepsis patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,None,COVID-19 late November/early December,None,,None,"['Arthralgia', 'Feeling abnormal', 'Hyperhidrosis', 'Insomnia', 'Pain']",1,MODERNA,IM 924826,NV,29.0,M,"Fever, chills, body aches, fatigue, and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924827,PA,21.0,F,Chills Body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,Spironolactone Depo-Provera injection,,Asthma,,Amoxicillin Claforan,"['Chills', 'Pain']",2,PFIZER\BIONTECH,IM 924828,FL,48.0,F,"12/23-12/25 immediate localized injection site reaction. 12/29-1/6 delayed type hypersensitivity, rubor. 1/6 treatment started, methylprednisolone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/29/2020,6.0,PUB,"Losartan-HCTZ, vitamin B complex, C and D multivitamin, loratidine",None,High blood pressure,,"ASA, penicillins, 3rd generation cephalosporins, sulfa drugs, cipro, clindamycin, gentamicin","['Erythema', 'Hypersensitivity', 'Injection site reaction']",1,MODERNA,IM 924829,MI,41.0,F,"Fever of 103.0, extreme fatigue, headaches, chills & body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,SEN,Levothyroxine 50mcg Multivitamin Calcium + Vit D3,Common cold approximately one week prior,Hypothyroidism,,Penicillins & Bactrim,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 924830,ME,42.0,F,"Roughly 12 hours after receiving dose number 2, I started to have body aches, general malaise, a headache, eye pane, and left ear pain. Around midnight, I started to experience severe chills along with the body aches. I woke up around 4:30 a.m. with a fever, 38.8?C orally. All other symptoms continued as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Levothyroxine Lilletta IUD,None,Hashimoto's thyroiditis,,None,"['Chills', 'Ear pain', 'Headache', 'Malaise', 'Ocular discomfort', 'Pain']",2,PFIZER\BIONTECH,IM 924831,CA,27.0,F,"Persistent throbbing headache started around midnight on 12/21/20. The headache did not subside with Tylenol, rest, nutrients, or hydration. The headache worsened with any head movements and made completing activities difficult. The headaches stopped by the morning of 12/23/20.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/21/2020,1.0,PVT,"Junel, Levothyroxine",No illnesses,Hypothyroidism,,No known allergies,['Headache'],1,PFIZER\BIONTECH,IM 924834,CO,48.0,F,"Tiredness first day after dose, second day 1/5/21 after 4PM extreme nausea, diarrhea, sore throat, and some SOB or labored breathing. Felt better after 1/6/21 after 4PM.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,SEN,Adderal ER 30 mg capsule taken once daily Adderal fast acting 15 mg tab taken once daily hours after first (above),None,None,,None,"['Diarrhoea', 'Dyspnoea', 'Fatigue', 'Nausea', 'Oropharyngeal pain']",1,PFIZER\BIONTECH,IM 924835,MA,23.0,F,"103.5 Fever that wouldn?t come down with Tylenol, chills, sharp headache, tachycardia, site pain, dizziness, body aches, nausea All symptoms started 11 hours after first dose of vaccine (3AM), went to hospital 15 hours after symptoms started and was treated for 9 hours until all symptoms abruptly stopped",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,None,"Diagnosed with covid December 1st, recovered 3 and a half weeks prior to vaccine",None,,None,"['Blood test normal', 'Chest X-ray normal', 'Chills', 'Dizziness', 'Electrocardiogram normal', 'Headache', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia', 'Tachycardia', 'Troponin normal', 'Urine analysis normal']",1,MODERNA,IM 924837,MA,40.0,F,8 days after receiving vaccine. Noticed redness swelling itching at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,"mybetriq, multivitamin, vitamin C",,Hepatitis B,,"Vicodin, seafood","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 924838,FL,66.0,F,"While waiting 15 minutes after the injection, I begin to feel my heart bounding. I checked my heart rate on my Apple watch, it was 165. The heart rate slowly came down to the 120's after approximately 30 seconds and remained their for thirty minutes. I felt better and left the vaccination location. Shortly after, while driving home my heartrate went up to 152 for approximately the same amount of time so I drove to my doctors office and explained what happen. They told me to go to the emergency room. By then my heartrate was 109 and I was feeling better. I did not feel the need to go to the emergency room, which I live less than a mile from the nearest hospital. Eventually my heartrate settled at 70-80's nearly 4 hours after the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,Losartan 50 mg daily - Norvasc 5 mg twice per day,None,"Hypertension, Sleep apnea",,None,['Palpitations'],UNK,MODERNA,IM 924839,,26.0,F,"Migraine, stomach upset",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,MIL,none,none,none,,none,"['Abdominal discomfort', 'Migraine']",1,MODERNA,IM 924840,IN,38.0,F,"Rash of arms and trunk, swollen and sore tongue, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,PVT,Wellbutrin XL 300 mg daily,None,Anemia,,None,"['Fatigue', 'Glossodynia', 'Rash', 'Swollen tongue']",1,MODERNA,IM 924841,FL,73.0,F,"Husband verbalized that wife was very anxious about the process and vaccination and after receiving the vaccine she was texting and reading while he was driving and she felt dizzy, She was evaluated by Rescue and at 1:35 pm was released to her home feeling good.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,Steion 10 mg,High Cholesterol,None,,None,"['Anxiety', 'Dizziness']",1,PFIZER\BIONTECH,IM 924842,OH,30.0,M,"Fever of 102.4 F, chills, decreased appetite, night sweats.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/17/2020,1.0,PVT,Generic Multivitamin,None,None,,NOne,"['Chills', 'Decreased appetite', 'Night sweats', 'Pyrexia']",1,PFIZER\BIONTECH,IM 924843,OH,34.0,F,"Raised, red, warm welt days 2-4 after vaccination with soreness. Not unusual for me after a vaccine, disappeared by day 5. Reappeared as a raised, red, warm welt without soreness on day 7 after vaccine. No other symptoms noted.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,Multivitamin Probiotic Prozac Spironolactone Adaptalene Cream Metolazone Cream,,,,NKDA,"['Erythema', 'Swelling', 'Tenderness', 'Urticaria']",1,MODERNA,IM 924844,OH,30.0,M,"Fever of 101.7F while taking 500mg of acetaminophen every 6 hours. Chills, night sweats, headache, fatigue, backache/myalgias.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,Multivitamin,"COVID-19 series 1 reaction with fever, chills, decreased appetite, fatigue, sweats.",None,,None,"['Back pain', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Night sweats', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924845,IA,37.0,F,"Migraine-like headache, low grade temp, extreme exhaustion, congestion",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/02/2021,3.0,PVT,Humira,Crohns Disease,Crohns Disease,,Sprionolactone,"['Fatigue', 'Migraine', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 924846,NY,51.0,F,"When giving the first dose, the vaccine leaked from the needle. Sprayed onto vaccinator and down patient arm. Unsure dose amount received. Call placed to Moderna for further direction.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Needle issue']",1,MODERNA,IM 924866,VA,70.0,U,"myelitis; postherpetic neuralgia; cardiovascular event; balance problems; Information has been received from a lawyer regarding a case in litigation referring to an elderly patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 15-MAY-2008, at the age of approximately 70 years old, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by health care providers (reported as providers) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: postherpetic neuralgia, myelitis, cardiovascular event and balance problems. The outcome of the events was not reported. Upon internal review, myelitis was determined to be medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,05/15/2008,,,UNK,,,,,,"['Balance disorder', 'Cardiovascular disorder', 'Myelitis', 'Post herpetic neuralgia']",UNK,MERCK & CO. INC.,OT 924869,CA,,U,"hemorrhage; stroke; intracranial infarction; Information has been received from a lawyer referring to a patient (pt) of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 22-FEB-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as after zoster vaccine live (ZOSTAVAX) inoculation), the pt suffered hemorrhage, stroke and intracranial infarction. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Th pt also experience mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events hemorrhage, stroke and intracranial infarction was not recovered. The reporter considered the events hemorrhage, stroke and intracranial infarction to be disability. Upon internal review, the events hemorrhage, stroke and intracranial infarction were determined to be medically significant.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/22/2016,,,UNK,,Routine health maintenance,,,,"['Cerebral infarction', 'Cerebrovascular accident', 'Haemorrhage']",UNK,MERCK & CO. INC.,OT 924870,UT,,U,"other zoster-related conditions; shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/ or administered by a healthcare provider at the medical office for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by healthcare providers at the medical office for shingles and other zoster-related conditions. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).",Not Reported,,Not Reported,Yes,,Not Reported,N,,,,PVT,,,,,,['Herpes zoster'],UNK,MERCK & CO. INC.,OT 924879,,,F,"had a severe reaction to PNEUMOVAX 23; This spontaneous report was received from a female patient of unknown age referring to herself. The patient's medical history, concurrent condition and concomitant medication were not provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis. On an unknown date, the patient had a severe reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) previously and was hospitalized. No additional adverse event details provided due to consumer being unable to be transferred to agent. The outcome of vaccination complication was unknown. The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was related.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,['Vaccination complication'],UNK,MERCK & CO. INC., 924884,,56.0,M,"positive COVID test; positive COVID test; fever; chills; sore throat; cough; nasal congestion; runny nose; little diarrhea; tiny bit of shortness of breath; Caller received the COVID-19 vaccine on 17Dec2020 and is scheduled to take the second dose on 5Jan2021.; Caller received the COVID-19 vaccine on 17Dec2020 and is scheduled to take the second dose on 5Jan2021.; sore arm; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable physician (patient himself). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), via intramuscular route on 17Dec2020 at single dose (dose 1, left deltoid) for COVID-19 immunization. The patient medical history included non-smoker. Concomitant medications were reported as none. The patient was scheduled to take the second dose on 05Jan2021, also reported as 08Jan2021. The patient experienced sore arm for 24 hours afterwards on Dec2020. Patient experienced mild COVID symptoms such as fever, chills, sore throat, cough, nasal congestion, runny nose, little diarrhea, and tiny bit of shortness of breath on 24Dec2020, but stated he was better now. The patient was positive in the COVID test on 28Dec2020. He wanted to know if it was normal to get COVID after getting the vaccine and if he should get the booster shot if he gets better. He commented that testing positive for COVID was medically concerning. The patient did not require supplemental oxygen (including high flow ECMO) or receive a mechanical ventilation. Treatment included over the counter medication. No additional testing was done. The patient was not hospitalized. Outcome of the event sore arm was unknown; cough was not recovered; fever, chills, sore throat, nasal congestion, runny nose, little diarrhea, tiny bit of shortness of breath was recovering. No follow-up attempts are needed. Information about lot/batch number was already obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: Non-smoker,,,"['Chills', 'Cough', 'Diarrhoea', 'Dyspnoea', 'Nasal congestion', 'Oropharyngeal pain', 'Pain in extremity', 'Pyrexia', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 924885,NV,58.0,F,"2days after my 1st Covid vaccine I broke out into a rash with hives requiring me to go to the ER; 2days after my 1st Covid vaccine I broke out into a rash with hives requiring me to go to the ER; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EH9899, expiry date was not provided) solution for injection, via an unspecified route of administration on left arm on 17Dec2020 08:00 at a single dose for Covid-19 immunization. Medical history included eczema, chronic kidney disease, thyroid disease. Patient had known allergies. The patient was not pregnant. Concomitant medications included apixaban (ELIQUIS), allopurinol (ALLOPURINOL), levothyroxine (LEVOTHYROXINE), iron (IRON), magnesium (MAGNESIUM). The patient reported that 2 days after her 1st Covid vaccine, she broke out into a rash with hives requiring her to go to the ER on 19Dec2020 12:00. She also visited a physician. She was treated with steroids, Atarax, and Epi shot. The events were reported as non-serious. Outcome of the events was not recovered. No follow-up activities are needed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of urticaria and rash due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/19/2020,2.0,PVT,ELIQUIS; ; ; ;,,Medical History/Concurrent Conditions: Allergy NOS; Chronic kidney disease; Eczema; Thyroid disorder,,,"['Rash', 'Urticaria']",1,PFIZER\BIONTECH, 924886,NJ,,U,"tested positive within 2-4 days of the vaccine; tested positive within 2-4 days of the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the first of 2 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse had questions about patients that received the first dose of the COVID 19 vaccine. One patient tested positive within 2-4 days of the vaccine and this patient had a known exposure to a COVID positive person. The nurse wanted to know if this patient should receive the second dose. The outcome of the events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of SARS-CoV-2 test positive and LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520414 Same reporter, drug, and events; different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 924887,AZ,40.0,F,"Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 18Dec2020, and was tested positive for COVID yesterday, 29Dec2020. States that she knows she only has had the first dose and states her exposure level was high, states that she cannot believe she made it this far before testing positive. Second dose scheduled for 08Jan2021, wanting to know if she should get the second dose since she was now positive. The outcome of the events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/29/2020,11.0,UNK,,,,,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 924888,CA,56.0,F,"positive Covid results with symptoms; positive Covid results with symptoms; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension (diagnosed 3-4 years ago), hyperlipemia (diagnosed 3-4 years ago), supraventricular tachycardia since 2017, and asthma; all ongoing. Family history included hypertension. She has no history of adverse reactions or allergies to any vaccines received previously. The patient's concomitant medications were not reported. The patient explains that she got the COVID-19 vaccine on 20Dec2020. Afterward she had some coughing, so she went for a rapid test and found she tested positive after the vaccine. The patient was wondering if this has been reported previously, where someone tested positive after getting the vaccine. She has never tested positive before. She got the results on 28Dec2020 that she was positive. She was now in a hotel quarantining. She was looking trying to find information on this occurring. Since she was in the hotel, she would prefer to use email as communication for follow-up. The patient noticed the cough on 25Dec2020. She works nights so she stayed home on the 26Dec2020. Then on 27Dec2020 she had the test done and on 28Dec2020 the results were given to her and she was positive. Her second dose was due on 10Jan2020 and it was before the 14 days of quarantine will be up. She was checking to see is there anywhere else she can get the second dose. The patient explains that she has been researching and she wanted to get it because she was with elderly family members. She wanted to know how she was tested positive, what test was used as she had the rapid test. There were no treatments for the events. The caller patient was also experiencing a cough, sore throat, and nasal congestion. There was no shortness or anything else going on at this point. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/27/2020,7.0,UNK,,Asthma; Hyperlipemia (diagnosed 3-4 years ago); Hypertension (diagnosed 3-4 years ago); Supraventricular tachycardia,Medical History/Concurrent Conditions: Hypertension,,,"['Cough', 'Nasal congestion', 'Oropharyngeal pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 924889,,,U,"positive person for Covid after receiving the Covid vaccine; positive person for Covid after receiving the Covid vaccine; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer-BioNTech COVID-19 Vaccine, lot/batch number and expiry date were unknown), via an unspecified route of administration on unknown date at single dose, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was a positive person for Covid after receiving the Covid vaccine on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 924890,CA,34.0,F,"Also had dizziness while sitting down. Felt like I would have fallen if I stood up so I sat for 20mins.; Mental confusion; couldn't gather my thoughts or write what I wanted to say; mental 'fog'; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 34-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm, on 28Dec2020 13:15 at single dose for COVID-19 immunization. Medical history allergy to penicillin. The patient is not pregnant during the time of vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and cefalexin (KEFLEX) and experienced allergies to both. The patient experienced mental confusion, mental 'fog', ""couldn't gather my thoughts or write what I wanted to say"", also had dizziness while sitting down (felt like I would have fallen if I stood up so I sat for 20mins) all on 28Dec2020 at 13:15. The patient did not receive treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 28Dec2020 at 13:45 (reported as events subsided after 30 minutes). The reporter assessed the case as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Cognitive disorder', 'Confusional state', 'Dizziness', 'Thinking abnormal']",1,PFIZER\BIONTECH, 924891,GU,,F,"Her measured blood pressure at 7:35 am was 180/80 but came down to 146/62 at 9:37 am; arms had some pain; chills; headache; a stiff neck pain at the back of her neck; a stiff neck pain at the back of her neck; a trembling pain; This is a spontaneous report from a contactable consumer. This is the 1st of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated on Dec2020, ""she reported that she herself felt fine but her arms had some pain. She was having chills, a headache, a stiff neck pain at the back of her neck, and a trembling pain. Her measured blood pressure at 7:35 am was 180/80 but came down to 146/62 at 9:37 am. Her pulse was at 62 bpm, Caller is asking for recommendations"". The outcome of ""her measured blood pressure at 7:35 am was 180/80 but came down to 146/62 at 9:37 am"" was recovering and other events was unknown. Information about Lot/batch no has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520380 same reporter/drug, different patient/event",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/01/2020,,UNK,,,,,,"['Chills', 'Headache', 'Musculoskeletal stiffness', 'Neck pain', 'Pain', 'Pain in extremity', 'Tremor']",UNK,PFIZER\BIONTECH, 924892,FL,89.0,M,"extremely lightheaded; like he was about to fall down; This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is the 1st of 2 reports. An 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL0140), intramuscular on the right arm on 30Dec2020 10:10 at single dose for vaccination. Medical history included covid-19 on Jul2020 and had it fairly severe and almost died and he mentions he was overweight. There were no concomitant medications. The patient previously took flu shot (INFLUENZA VACCINE), a couple of months ago. He mentions he was in the military so he had a lots of shots in his life but he has never had a reaction like this. The patient stated that on 30Dec2020 10:30, ""he became extremely lightheaded, like he was about to fall down. He sat down and is currently sitting down. This lightheadedness started about 20 minutes after the injection. When probed for the outcome, the caller explains it might be improving a little. The lightheadedness is not still not gone, but it has not worsened. When probed for seriousness criteria, the caller explains he is just resting and sitting. He would say its not serious but it could be medically significant. He states he isn't sure if this is something that happens to just people who have had COVID before. He states none of his friends or relatives have this type of reaction. He lives in a retirement home and everybody is getting the injection. This is the second day of injections. He doesn't know if anybody had a reaction to the COVID-19 vaccine here"". The outcome of the events were recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of lightheadedness and pre-syncope due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520862 same reporter/drug, similar event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,,,Medical History/Concurrent Conditions: COVID-19; Overweight,,,['Dizziness'],1,PFIZER\BIONTECH,OT 924893,PA,57.0,F,"Vomiting/threw up; Headache; muscles got rigid and tight in her neck; muscles got rigid and tight in her neck; sick; She doesn't know if she had the flu bug or not; She also had very high blood pressure. It was through the roof/Blood pressure was high and she was concerned she would have a stroke; Muscle soreness; Arm soreness; This is a spontaneous report from a contactable healthcare professional (physical therapist). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 21Dec2020 08:15 at a single dose for COVID-19 immunisation; and sumatriptan from 25Dec2020 to an unspecified date at unknown dose and frequency (standard unknown dose/ She only gets 9 pills a month) for migraine. Medical history included ongoing migraine, obesity (She would say she was kind of obese), coeliac disease (She had Celiac disease and cannot eat gluten which was diagnosed since she was 4), chronic back pain (this was diagnosed a couple of years before she took the COVID vaccine), spinal stenosis (this was diagnosed a couple of years before she took the COVID vaccine), and pain (she took hydrocodone for pain but did not take any that day). Concomitant medication included hydrocodone for pain. Prior Vaccinations (within 4 weeks) and events following prior vaccinations were none. The patient had the vaccine on 21Dec2020, and she got sick on Christmas day. She was vomiting at 14:00 and did not know if it was a side effect or not. She did have arm soreness muscle soreness at 15:00, that evening and the next day too. She normally gets a migraine once a month. She does not normally throw up with a headache though. The vomiting started when she threw up twice on 25Dec2020, then once on morning of 26Dec2020. She also had very high blood pressure. It was through the roof. She did not know if that was related to drug for migraine or vaccine. She also had the headache at 14:00 the whole time. She believed she threw up before she took Sumatriptan. The muscles got rigid and tight in her neck and she doesn't think she took it. She threw up and then she took it. She did not have a lot or expiration. There was no ER nor physician's office required. She would have it if her car was not buried in snow. Her blood pressure was high and she was concerned she would have a stroke. It was usually around 110/70 and was always very low usually. She did not know if it was accurate, but it was 165/124 at one point and she did know her pulse was accurate. She did not provide her pulse rate. She did not know if she was throwing up because her blood pressure was high and did not know if blood pressure was high because of Sumatriptan. She only gets 9 pills a month. She did not know if high blood pressure was one of the side effects. It was not a real safe medication to take once a day. She only took it once a month and only once that day. She had never thrown up with migraines before and was just concerned. She doesn't usually take her blood pressure and doesn't know if the Sumatriptan always makes it go up or not. She doesn't know if she had the flu bug or not. The action taken in response to the events for bnt162b2 was not applicable, while for sumatriptan was unknown. Clinical outcome of sickness and influenza was unknown, for headache was recovered on 27Dec2020, while for the other events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the elevated BP and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,PVT,,Migraine,Medical History/Concurrent Conditions: Celiac disease (She has Celiac disease and cannot eat gluten. This was diagnosed since she was 4.); Chronic back pain (This was diagnosed a couple of years before she took the COVID vaccine.); Obesity (She would say she is kind of obese); Pain (She takes Hydrocodone for pain but did not take any that day.); Spinal stenosis (This was diagnosed a couple of years before she took the COVID vaccine.),,,"['Headache', 'Hypertension', 'Malaise', 'Muscle rigidity', 'Muscle tightness', 'Myalgia', 'Pain in extremity', 'Vomiting']",UNK,UNKNOWN MANUFACTURER, 924894,CA,45.0,F,"allergic reaction; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK 5730, expiry date unknown) via unspecified route of administration at left arm on 30Dec2020 08:30 at single dose for Covid-19 immunization in a hospital facility. The patient was not diagnosed with Covid-19 prior vaccination. Medical history was none. Concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 at 08:45, the patient experienced allergic reaction which resulted to patient visiting doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. The patient received treatment of epinephrine, decadron and Benadryl due to the event. The patient was not Covid tested post vaccination. The outcome of the event allergic reaction was recovering at this time of the report. The reporter considered the event non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Allergic reaction cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Hypersensitivity'],1,PFIZER\BIONTECH, 924895,PA,34.0,F,"peripheral neuropathy type symptoms; tingling of the feet, legs, hands, arms; This is a spontaneous report from a contactable Other Health Professional (patient). A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at Left arm on 22Dec2020 10:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypothyroidism. The patient had no known allergies. Concomitant medication included levothyroxine and multivitamin. No other vaccine in four weeks. The patient was not sure if this was related to the vaccine or not. The patient didn't know if anyone else was having peripheral neuropathy type symptoms such as tingling of the feet, legs, hands, arms. The symptoms started a few days ago. The patient did not even sure if it related to the vaccine. Adverse event start date was 27Dec2020. Covid was not tested post vaccination. The outcome of the events was not recovered. No treatment received for the events. Information on the lot/batch number has been requested.; Sender's Comments: The temporal relationship between the onset of the event and administration of the vaccine does not support a causal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/27/2020,5.0,PVT,,,Medical History/Concurrent Conditions: Hypothyroidism,,,"['Neuropathy peripheral', 'Paraesthesia']",1,PFIZER\BIONTECH, 924896,PA,61.0,F,"Mild- moderate tenderness in left deltoid; This is a spontaneous report from a contactable physician. A 61-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number=EK 9231, via an unspecified route of administration, in left arm, on 30Dec2020 at 13:45 (at the age of 61 years-old for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included allergic rhinitis, a distant history of thyroid cancer and an allergy to iodine. Concomitant medication included biotin (BIOTIN), cetirizine (CETIRIZINE), fish oil (FISH OIL), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), levothyroxine sodium (SYNTHROID). . The patient has not had any vaccinations in 4 weeks. The patient has taken other medications (concomitant medications) within 2 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 31Dec2020 at 0700 the patient experienced mild- moderate tenderness in left deltoid. The patient was not hospitalized for the event nor received any treatment. The clinical outcome of the mild- moderate tenderness in left deltoid was recovering. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,; ; ; FLONASE [FLUTICASONE PROPIONATE]; SYNTHROID,,Medical History/Concurrent Conditions: Allergic rhinitis; Iodine allergy; Thyroid cancer (distant h/o thyroid cancer),,,['Vaccination site pain'],1,PFIZER\BIONTECH, 924897,TX,,F,"feels pretty sick; Nauseous; going to the bathroom a lot; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported for a female patient of an unspecified age received BNT162b2, via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. Medical history included tooth extraction and bone graft, and was not feeling real well after that. The patient's concomitant medications were not reported. Patient received COVID vaccine on 28Dec2020. Patient stated she feels pretty sick since getting the COVID-19 Vaccine, saying she is mainly nauseous and going to the bathroom a lot; all from 30Dec2020. The patient said she went to the dentist, and got an antibiotic. She was prescribed Amoxicillin 500mg, three times a day, by her dentist. She said she took her first dose of Amoxicillin 500mg this morning (31Dec2020). She said after she took the first Amoxicillin 500mg dose, she thought she better check to see if it is OK to take an antibiotic after receiving the COVID-19 Vaccine. She did not necessarily think the nausea and going to the bathroom a lot had to do with receiving the COVID-19 Vaccine. She wanted to know if she takes an antibiotic after receiving the COVID-19 Vaccine, will the antibiotic cause a problem with the COVID-19 Vaccine. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product events most likely due to patient underlying contributory factors",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/30/2020,2.0,UNK,,,"Medical History/Concurrent Conditions: Bone graft (tooth extraction and bone graft, and was not feeling real well after that.); Feeling unwell (tooth extraction and bone graft, and was not feeling real well after that.); Tooth extraction (tooth extraction and bone graft, and was not feeling real well after that.)",,,"['Frequent bowel movements', 'Malaise', 'Nausea']",UNK,PFIZER\BIONTECH, 924898,IN,34.0,F,"tested positive for covid; tested positive for covid; fever; headache; runny nose; nasal congestion; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first single dose of BNT162B2 (Solution for injection, lot number: EK5730, exp date: Mar2021), intramuscular (injected in left upper arm ) on 20Dec2020 12:30 to 20Dec2020 12:30 at 0.3 mL for immunisation. The vaccine was administered in a hospital and not in a military facility. Medical history included birth control. The patient had no other history. NO ER or physician's office required Prior Vaccinations (within 4 weeks). Patient had no relevant family history. Concomitant medication include unspecified birth control.There was no previous immunization. Patient, who was a Respiratory therapist, got the covid vaccine on 20Dec2020 (Sunday). She first stated she doesn't have any side effects and just had a question. Patient had COVID Symptoms on 26Dec2020 21:00 which was minimal like a runny nose. She further reports that on 26Dec2020 she started to have nasal congestion. On 27Dec2020 the nasal congestion worsened, and she started having a headache. She then experienced a 102.6 fever on 28Dec2020 (Monday). She has since tested positive for Covid on 28Dec2020 11:30. Patient asked if it was ok that she received the 2nd dose after testing positive for covid. Investigation assessment was not performed. There was no prescriber. She received at work because she was a front line healthcare worker. The patient does not have SARS-CoV2 antibodies at diagnosis but never tested for antibodies. The patient was not in the hospital, nor was admitted in ICU. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. No Multiorgan failure. The patient did not receive any additional therapies for COVID-19. The patient did not require the initiation of new medication or other treatment or procedure. PCR on 28Dec2020 (Saturday) Results: just detected. No units available. No reference ranges provided. Standard range was not detected. It was just detected or not detected ranges. No other test or diagnostic imaging performed. The patient had not been treated with immune modulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. No pre-existing diseases worsened during the SARS-CoV2 infection. The patient was recovering from event positive for covid and runny nose; nasal congestion was not recovered and outcome of the other events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/26/2020,6.0,PVT,,,Medical History/Concurrent Conditions: Birth control,,,"['COVID-19', 'Headache', 'Nasal congestion', 'Pyrexia', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 924899,PA,37.0,F,"had side effects of ""tongue feels swollen and globus sensation in my throat.""; had side effects of ""tongue feels swollen and globus sensation in my throat.""; she did not have a lot of injection site pain, it very minimal.; bruise or ecchymosis at the injection site; bruise or ecchymosis at the injection site; This is a spontaneous report from a contactable physician (patient) via a Pfizer sponsored program Pfizer First Connect. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899) via intramuscular on 19Dec2020 09:00 on left deltoid at a single dose for COVID-19 prophylaxis. The patient medical history, family history and relevant tests were reported as none. Current concomitant medications included multivitamin took 2 chewable gummies sporadically for years as supplementation therapy. The patient previously took Flu shots she got a sore arm. It was not bad. Tetanus gives her a sore arm, but that was all. Caller wanted to know what she should do for preparation to safely get second dose of Covid vaccine and how to fix what she was feeling right now, making sure it doesn't get worse, considering she is still having symptoms. Caller stated that she had side effects of tongue felt swollen and globus sensation in her throat. The transferring agent stated that he has a caller on the line that was calling about the Covid-19 Vaccine and reported that the patient got the shot on the 19Dec2020 and was inquiring about to proceed with her weird side effects. Caller had not told her physician about her symptoms yet. Caller clarified that she said a half an hour after the dose on 19Dec2020 09:30 she said that she had a Globus sensation or like a lump in her throat. Caller also reported that the back of her tongue felt swollen. Caller said that the Globus sensation was intermittent and it was not as prominent now as it was. Caller said that it was medically significant, but she has not sought medical treatment yet. Caller said that she still had a bruise or ecchymosis at the injection site. She said that the injection was high but reported that she did not have a lot of injection site pain, it very minimal. No emergency room or physician office required. The outcome of the event tongue felt swollen and globus sensation in her throat was recovering and the outcome of the event a bruise or ecchymosis at the injection site was not recovered and the outcome of the event minimal injection site pain was unknown.; Sender's Comments: There is a plausible chronological association between vaccine administration and onset of the events. Causality cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/01/2020,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Injection site bruising', 'Injection site haemorrhage', 'Injection site pain', 'Product administered at inappropriate site', 'Sensation of foreign body', 'Swollen tongue']",1,PFIZER\BIONTECH,OT 924900,PA,35.0,F,"had a reaction of bells palsy with mild symptoms 5 minutes of receiving covid vaccine; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; This is a spontaneous report from a contactable Other Health Professional reported that a 35-year-old female patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications was not reported. The patient experienced a reaction of bells palsy with mild symptoms 5 minutes of receiving Covid vaccine. ""facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better, patient was vaccinated 10 days ago on 21Dec2020. Patient was treated with 60mg of Prednisone for 5 days which was started today."" Question is regarding the 2nd dose of Covid vaccine, whether or not she should have it. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. .; Sender's Comments: There is a positive chronological association between vaccine administration and onset of the events. Causality cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,PVT,,,,,,"['Ear discomfort', 'Eyelid function disorder', 'Facial paralysis', 'Facial paresis', 'Hypoaesthesia']",1,PFIZER\BIONTECH, 924901,WA,45.0,F,"felt flushed; itch and felt tightness in her throat; itch and felt tightness in her throat; fatigue; arms and legs feel heavy; This is a spontaneous report from a contactable nurse (patient herself). A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: Ek5730, expiration date: unknown), via an unspecified route of administration on the left arm on 30Dec2020 at 08:00 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included Hashimotos, Celiac, nonalcoholic fatty liver, and known allergies to gluten, eggs whites and eggs yolks, mustard seed, and penicillin. Concomitant medications included cetirizine hydrochloride (ZYRTEC), thyroid (NATURE THROID), and an unspecified women's multivitamin. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Dec2020 at 08:15, also reported as within 10 minutes, the patient felt flushed and at 20 minutes, she started to itch and felt tightness in her throat. The patient left after 30 minutes to go home and take diphenhydramine (BENADRYL). The patient worked at night and slept most of the day except to take BENADRYL and call out from work. Also on 30Dec2020, she noticed fatigue when she woke in the afternoon and her arms and legs felt heavy. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of itch and felt tightness in her throat. She had been on BENADRYL 50 mg every 4-6 hours. The itching and throat tightness remained unchanged. She had used an albuterol inhaler 3 times. The patient did not receive treatment for the other events. The patient was not recovered from the events ""felt flushed, itch and felt tightness in her throat, fatigue, and arms and legs feel heavy.""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,ZYRTEC [CETIRIZINE HYDROCHLORIDE]; NATURE THROID,,Medical History/Concurrent Conditions: Allergy to plants; Celiac disease; Egg allergy; Gluten sensitivity; Hashimoto's disease; Nonalcoholic fatty liver disease; Penicillin allergy,,,"['Fatigue', 'Flushing', 'Limb discomfort', 'Throat irritation', 'Throat tightness']",1,PFIZER\BIONTECH, 924902,TX,,F,"now have a positive cov-19 test results; now have a positive cov-19 test results; This is a spontaneous report from a contactable nurse reporting for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, on an unspecified date, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient took first round of cov-19 shot and due to take 2nd one Saturday but now have a positive cov-19 test result. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 924903,PA,40.0,F,"Swollen and numb upper lip; Swollen and numb upper lip; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), via an unspecified route of administration in the left arm on 31Dec2020 at 12:30 PM (at the age of 40-year-old) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus, high cholesterol, and hypothyroidism. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included atorvastatin (LIPITOR), metformin, sitagliptin (JANUVIA), empagliflozin (JARDIANCE), and dulaglutide (TRULICITY). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 07:00 AM, the patient experienced swollen and numb upper lip. The events were reported as non-serious. The patient did not receive any treatment for the swollen and numb upper lip. The clinical outcome of the swollen and numb upper lip was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,LIPITOR [ATORVASTATIN]; ; JANUVIA [SITAGLIPTIN]; JARDIANCE; TRULICITY,,Medical History/Concurrent Conditions: Diabetes; High cholesterol; Hypothyroidism,,,"['Hypoaesthesia oral', 'Lip swelling']",1,PFIZER\BIONTECH, 924904,IN,32.0,F,"Painful, swollen lymph node in left axilla, same side as injection site; Painful, swollen lymph node in left axilla, same side as injection site; This is a spontaneous report from a contactable healthcare professional (the patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number Ek5730), intramuscularly in the left arm on 22Dec2020 at 16:00 (at the age of 32-years-old) as a single dose for COVID-19 immunization. There was no medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included tramadol, cyclobenzaprine hydrochloride (FLEXERIL), ibuprofen (ADVIL), paracetamol (TYLENOL), all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020, the patient experienced painful, swollen lymph node in left axilla, same side as injection site. No treatment was given for these events. The clinical outcome of painful, swollen lymph node in left axilla, same side as injection site was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/29/2020,7.0,PVT,; FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]; ADVIL; TYLENOL,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,OT 924905,WA,28.0,F,"swollen lymph node in her left axilla/lymphadenopathy; pain in her left axilla; able to palpate a swollen lymph node in her left axilla; This is a spontaneous report from a contactable physician (the patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1685), intramuscularly in the left arm on 17Dec2020 at 11:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. There was no medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included famotidine and fexofenadine hydrochloride (ALLEGRA), both for unknown indications from unknown dates and unknown if ongoing. The patient previously took and had an allergy to amoxicillin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 23Dec2020 at 13:00, the patient developed pain in her left axilla (6 days after vaccination). The patient was able to palpate a swollen lymph node in her left axilla. It continued to become more painful requiring ibuprofen and hot compresses. By 31Dec2020, her symptoms had largely resolved. She saw her physician who also felt the lymphadenopathy and had no other explanation than possible vaccine side effect. The clinical outcome of pain in her left axilla, swollen lymph node in her left axilla/lymphadenopathy, able to palpate a swollen lymph node in her left axilla was recovered on 31Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/23/2020,6.0,PVT,ALLEGRA;,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Axillary pain', 'Lymph node palpable', 'Lymphadenopathy']",1,PFIZER\BIONTECH, 924906,NY,46.0,F,"Contracted covid 19 virus after receiving first dose of vaccine; Contracted covid 19 virus after receiving first dose of vaccine; This is a spontaneous report from a contactable nurse. A 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Eh9899), intramuscular in left arm on 17Dec2020 18:00 at a single dose for covid-19 vaccination. Vaccine was administered in the hospital. There were no relevant medical history. The patient had no known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID). On 27Dec2020 20:00, the patient contracted covid 19 virus after receiving first dose of vaccine. The outcome of the event was recovering. The patient did not received any treatment. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient did not have COVID prior to vaccination. The patient was tested for COVID post vaccination. The patient had nasal swab on 31Dec2020 and had a positive result.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/27/2020,10.0,PVT,SYNTHROID,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 924907,MI,50.0,M,"Fever 37.8 chills injection site pain; Fever 37.8 chills injection site pain; Fever 37.8 chills injection site pain; This is a spontaneous report from a contactable nurse, the patient. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection in the left arm on 31Dec2020 at 08:15 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. Medical history included Type2 DM (diabetes mellitus), hypertension, obesity, gout and Covid-19. Concomitant medications included unspecified medication(s). The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was previously diagnosed with COVID-19. On 01Jan2021 at 14:00, the patient experienced fever 37.8, chills and injection site pain. Treatment was provided for the events fever, chills and injection site pain included acetaminophen (TYLENOL 650mg). The outcome of the events fever, chills and injection site pain was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,UNK,,,"Medical History/Concurrent Conditions: COVID-19 (if covid prior vaccination: Yes); Gout (Type2DM (diabetes), hypertension, obesity, gout); Hypertension (Type2DM (diabetes), hypertension, obesity, gout); Obesity (Type2DM (diabetes), hypertension, obesity, gout); Type 2 diabetes mellitus (Type2DM (diabetes), hypertension, obesity, gout)",,,"['Body temperature', 'Chills', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 924908,,,F,"tested positive following the first dose of vaccine; tested positive following the first dose of vaccine; This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she has a patient who tested positive following the first dose of vaccine and inquiring as to second dose recommendations. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: There is scant information at this point. Case will be reevaluated based on additional information during the follow-up",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 924909,FL,43.0,F,"heart palpitations starting 3 days after receiving vaccine; This is a spontaneous report from a contactable Nurse reporting for self. A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 18Dec2020 08:45 as a single dose (Dose 1), right arm (age at vaccination 42-years old) for COVID-19 immunization. The patient is not pregnant and did not receive any other vaccine in the 4 weeks prior to the COVID-19 vaccine. Medical history included diabetes mellitus, drug hypersensitivity, and allergies sulfa. the patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (PRILOSEC), aripiprazole (ABILIFY), zolpidem tartrate (AMBIEN), famciclovir (FAMVIR), semaglutide (OZEMPIC), and cetirizine hydrochloride (ZYRTEC). On 21Dec2020 at 16:00, the patient experienced heart palpitations starting 3 days after receiving vaccine. The event was reported as non-serious. No treatment was received for the event. The palpitations were resolving. The patient wasn't COVID tested post-vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/21/2020,3.0,PVT,PRILOSEC [OMEPRAZOLE]; ABILIFY; AMBIEN; FAMVIR [FAMCICLOVIR]; OZEMPIC; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Diabetes; Sulfonamide allergy (allergies:sulfa),,,['Palpitations'],1,PFIZER\BIONTECH,OT 924910,TX,33.0,F,"Dizziness; Nausea; This is a spontaneous report from a contactable other hcp, the patient. This 33-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly in the right arm on 28Dec2020 at 07:45 (at the age of 33-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was reported as none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication was reported as none and no other medications were received within 2 weeks of the vaccination. On 28Dec2020 at 08:00, the patient experienced dizziness and nausea. No therapeutic measures were taken as a result of the events. The events resulted in the patient requiring a doctor/clinic visit. The clinical outcome of dizziness and nausea was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dizziness', 'Nausea']",UNK,PFIZER\BIONTECH, 924911,CA,45.0,F,"Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Sleep affected- awake 22 hours; Hyperactive anxiety reaction; This is a spontaneous report from a contactable nurse reporting for herself. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EJ1685 /expiration date: not provided), via an unspecified route of administration in the left arm, on 28Dec2020 at 07:45 AM (at the age of 45 years old) as a single dose for COVID-19 vaccination. Relevant medical history included penicillin allergy. The patient did not have any chronic diseases or illnesses. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 at 10:00 AM, the patient experienced hyperactive anxiety reaction- restless, impulsive and hyperactive. The patient could not sit still or control fidgeting and her sleep was affected, as she was awake 22 hours. The patient did not receive treatment for the events. The outcome of the events hyperactive anxiety reaction- restless, impulsive and hyperactive and sleep was affected was recovered on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Anxiety', 'Impulsive behaviour', 'Insomnia', 'Psychomotor hyperactivity', 'Restlessness']",1,PFIZER\BIONTECH, 924912,MN,68.0,M,"joint pains; muscle aches; malaise; chills; fatigue; very mild headache; This is a spontaneous report from a contactable physician reporting on himself. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL0140/expiration date: not provided), via an unspecified route of administration, on 30Dec2020 at 05:00 PM (at the age of 68 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history included hypertension, gout, dyslipidemia, and dysthymia. The patient did not have any known allergies to any medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within two weeks were taken but were not provided. The patient did not receive any other vaccines on the same date or within 4 weeks prior to the COVID vaccine. On 31Dec2020, at 08:30 PM, the patient experienced joint pains, muscle aches, malaise, chills, fatigue, and very mild headache. The patient did not receive and treatment for these events. The outcome of the events joint pains, muscle aches, malaise, chills, fatigue, and very mild headache was recovering. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Dyslipidemia; Dysthymia; Gout; Hypertension,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Malaise', 'Myalgia']",1,PFIZER\BIONTECH, 924913,,,M,"sore arm; aches and pains for a couple of days; a little headache; I received results yesterday and I am positive; I received results yesterday and I am positive; This is a spontaneous report from a non-contactable physician (patient). A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date was unknown, via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first covid vaccine dose on 19Dec2020, and due to get his second dose on 09Jan2021. The problem is he tested for the covid virus on Wednesday 26Dec2020 (was negative). He was tested again on the 30Dec2020, because his wife and son had tested positive on the 26Dec2020, he received the results yesterday and he is positive. He asked if he should proceed with the 2nd dose, another test on the 30th and tested positive. He reports that, other than initial side effects from the vaccine administration, sore arm, aches and pains for a couple of days, never had fever, a little headache for a day or two, he feels fine. The outcome of the events ""a little headache"" was recovered on an unspecified date while outcome of the other events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/30/2020,11.0,UNK,,,,,,"['Exposure to SARS-CoV-2', 'Headache', 'Pain', 'Pain in extremity', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 924914,TN,30.0,F,"Injection site pain; headache for 2 days; neck and lower back joint pain; neck and lower back joint pain; fever of 101; nausea; chills; neck and lower back joint pain; lethargy; This is a spontaneous report from a contactable Nurse (the patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899, expiration date unknown), intramuscularly, on 31Dec2020 at 07:30 (at the age of 30-years-old) an unspecified dose in the left arm for COVID-19 vaccination. Medical history included anxiety and depression from unknown dates. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 01:00 the patient experienced vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101 degrees, nausea, chills and lethargy. The patient did not receive any treatment for the events. The clinical outcomes of vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101degrees, nausea, chills and lethargy were reported as recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Anxiety; Depression,,,"['Arthralgia', 'Back pain', 'Chills', 'Headache', 'Lethargy', 'Nausea', 'Neck pain', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 924915,AK,,F,"Dry mouth and throat; Dry mouth and throat; This is a spontaneous report from a non-contactable consumer, the patient. An adult female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number Gl5730), via an unspecified route of administration in the left arm on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medication was none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Dec2020 the patient experienced dry mouth and throat. The events were reported as non-serious. The patient did not receive any treatment for the dry mouth and throat. The clinical outcome of dry mouth and throat was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/18/2020,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dry mouth', 'Dry throat']",1,PFIZER\BIONTECH, 924916,,,F,"swelling; tenderness; a red lump at the injection site; a red lump at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient was Covid 19 positive in Aug2020. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced swelling, tenderness, and a red lump at the injection site. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,,,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['SARS-CoV-2 test', 'Swelling', 'Tenderness', 'Vaccination site erythema', 'Vaccination site mass']",UNK,PFIZER\BIONTECH, 924917,,,M,"tested positive with COVID; tested positive with COVID; This is a spontaneous report from a contactable nurse. A male patient (Age:22 Units: unspecified) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 15Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the 1st dose last 15Dec2020 and tested positive with COVID on 25Dec2020. The outcome of the event was unknown. He will have the COVID result 04Jan2021 to check if he was still positive. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/15/2020,12/25/2020,10.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 924918,CA,48.0,F,"Sore arm and fatigue after 30 minutes; Sore arm and fatigue after 30 minutes; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231), via an unspecified route of administration in the left arm 02Jan2021 at 12:00 PM (at the age of 48-year-old) as a single dose for COVID-19 immunization. Medical history included asthma, gastritis, and hypothyroidism. The patient had allergy to Sulfa. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine, formoterol fumarate, mometasone furoate (DULERA), salbutamol (ALBUTEROL HFA), omeprazole (PROTONIX), and alprazolam (XANAX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jan2021, at 12:30 PM, the patient experienced sore arm and fatigue after 30 minutes. The events were reported as non-serious. The patient did not receive any treatment for the sore arm and fatigue after 30 minutes. The clinical outcome of the events sore arm and fatigue after 30 minutes was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,PHM,; DULERA; ALBUTEROL HFA; PROTONIX [OMEPRAZOLE]; XANAX,,Medical History/Concurrent Conditions: Asthma; Gastritis; Hypothyroidism; Sulfonamide allergy,,,"['Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH, 924919,,25.0,F,"Fever; Chills; Itchy neck outside; Itchy throat; Stiff shoulder; Pin and needles; joint pain in shoulder and arms; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 25-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EL1284, expiration date: unknown), intramuscularly on the right arm on 31Dec2020 at 15:30 at a single dose for COVID-19 immunization administered at the hospital. The patient's medical history and concomitant medications were not reported. The patient had no known allergies; no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Dec2020 at 19:00, the patient experienced fever, chills, itchy neck outside, itchy throat, stiff shoulder, pin and needles, and joint pain in shoulder and arms. The reporter assessed the events as non-serious. The patient did not receive any treatment for the events. The patient was recovering from all the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Arthralgia', 'Chills', 'Musculoskeletal stiffness', 'Paraesthesia', 'Pruritus', 'Pyrexia', 'Throat irritation']",1,PFIZER\BIONTECH,OT 924920,,38.0,F,"headache; This is a spontaneous report from a contactable consumer, the patient. This 38-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 03Jan2021 (at the age of 38-years-old) as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medication were not reported. On 03Jan2021 (reported as early today), the patient reported she feels fine, but has a little bit of a headache. She did not know if her headache was due to the vaccine or other reasons. The patient wanted to know if she could take ibuprofen. The clinical outcome of the headache was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,UNK,,,,,,['Headache'],UNK,PFIZER\BIONTECH, 924921,,,F,"could not taste or smell; could not taste or smell; nasal congestion; Achyall over; Vomited; Migraine; lungs started burning; persistent dry cough; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 21Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced achy all over, vomited, migraine, lungs started burning, and persistent dry cough on 21Dec2020 and could not taste or smell and nasal congestion on 22Dec2020 at 15:00. The clinical course was reported as: The patient felt a little achy, then vomited. She had a migraine for 2 hours, lungs started burning, and had a persistent dry cough. The patient was achy all over. At about 3:00 PM the next day, the patient could not taste or smell and had nasal congestion. The patient stated that this could be typical for positive COVID-19 infection. The patient was later getting better and feeling better. The clinical outcome of achy all over, vomited, lungs started burning, persistent dry cough, could not taste or smell, and nasal congestion was recovering and of migraine was recovered in Dec2020. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,UNK,,,,,,"['Ageusia', 'Anosmia', 'Cough', 'Migraine', 'Nasal congestion', 'Pain', 'Pulmonary pain', 'Vomiting']",UNK,PFIZER\BIONTECH, 924922,,,F,"developing a left facial droop; Bell's palsy; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable physician reported that a female patient of an unspecified age received the first dose of bnt162b2 (COVID-19 Vaccine) via an unspecified route of administration on an unspecified date in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician reported that the patient received the COVID-19 vaccine roughly two weeks ago (Dec2020) and is developing a left facial droop, they are concerned if that is a sign of facial Bell's palsy. It's left side and it's a facial droop. The physician was concerned if patient is developing Bell's palsy and they are wondering if she should get the second dose or not. The physician further stated that her patient got the vaccine like about 2 weeks ago and developed Bell's palsy three days after the administration of the vaccine (Dec2020) and of course she won't be able to get to see because we are all booked up until yesterday and that is like about a week ago, after the onset of Bell's palsy. Outcome of the event was unknown. Information about lot and batch has been requested.; Sender's Comments: The event is considered possibly related to the suspect product based on the assumed positive temporal association. The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular the following relevant information is not available: patient's medical history and concomitant medications, exact vaccination date, event outcome. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,['Facial paralysis'],1,PFIZER\BIONTECH, 924923,FL,61.0,F,"Cold/ cold like symptoms; Sore throat; Congested/ sore throat; Sore arm; I was hurting for a day; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscular on left arm at single dose for COVID-19 immunization on 23Dec2020 at 61-year-old. No medical history or concomitant medication. Yesterday (30Dec2020), the patient woke up with a sore throat, it was like getting cold with a sore throat, congested, the patient had cold like symptoms, seemed like the patient was getting a cold. The patient just took decongestant medication. After waking up this morning (31Dec2020) the patient did not have taken anything. The patient got tested for COVID (for antigen not a PCR) yesterday (30Dec2020) and was negative. The patient did not have got any fever, just sore arm a week ago (Dec2020). She was hurting for a day and then she was good, everything good. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/01/2020,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Nasopharyngitis', 'Oropharyngeal pain', 'Pain in extremity', 'SARS-CoV-2 test', 'Upper respiratory tract congestion']",1,PFIZER\BIONTECH,OT 924924,FL,40.0,M,"lost his sense of smell/cannot smell anything; Sore throat; sweating a lot; Fever; chills; body felt cold; This is a spontaneous report from a contactable consumer (patient) reported that a 40-year-old male patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: EH9899 and Expiration Date: 31Mar2021) via an unspecified route of administration on 21Dec2020 14:30 at single dose in left arm for Precaution (covid-19 immunization). NDC number of Pfizer COVID Vaccine: 59267-1000-2. The patient's medical history and concomitant medications was reported as none. The patient works in a hospital and got the first shot. Before he got the vaccine, he did not have any symptoms and felt great. They told him he may feel some symptoms for a couple of days. Now, he was getting symptoms of COVID 2 nights ago (around 20:00 28Dec2020) such as fever, chills, body felt cold, fever. Last night (30Dec2020) when he slept, he sweated a lot. Maybe it is one of the reasons. He did not have a fever, but he sweated a lot. He felt like his shirt was wet in the morning. He also had sore throat and lost his sense of smell on 06:00 31Dec2020. It is weird. He never had that before. He doesn't know what the do. If it was normal or it was symptoms of COVID. Second one will be on 12Jan2020. Should he get tested for COVID. Wanted to know if he should get the second dose. The outcome of events, fever, chill, felt cold, sweating a lot was recovering. The outcome of sore throat and cannot smell anything was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/28/2020,7.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Anosmia', 'Chills', 'Feeling cold', 'Hyperhidrosis', 'Oropharyngeal pain', 'Pyrexia']",1,PFIZER\BIONTECH, 924925,PA,,U,"nurse got Covid after getting the vaccine; nurse got Covid after getting the vaccine; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that a nurse got Covid after getting the vaccine. The reporter wanted to know if the chills were common. She wanted to know if it is okay to feel chills every now and then. She wanted to know how people would know if they are positive when getting the vaccine. The outcome of the event was unknown. Information about the lot/batch number has been requested.; Sender's Comments: Based on the limited information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Chills']",UNK,PFIZER\BIONTECH, 924926,MI,49.0,F,"a strong, whole body heat, and flushing; a strong, whole body heat; tachycardic; Palpitations; This is a spontaneous report from a contactable Nurse(patient). This Nurse reported for similar events for 6 patients. This is 1st of 6 reports. A 49-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at the 49 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The registered nurse and 5 other registered nurses she worked with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a weird reaction right after she was injected with the COVID-19 Vaccine. She had a strong, whole body heat, and flushing. She said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. The patient said she had no other symptoms after receiving the COVID-19 Vaccine. The reporter said there were 5 other registered nurses that received the COVID-19 Vaccine at the same time and had the same exact symptoms she experienced. The reporter said stated the registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter stated she did not know if the patient had received any other vaccines at the same time as the COVID-19 Vaccine, and if the patient had received any other vaccines within the last 4 weeks. The patient works at a hospital but didn't received any medical treatment. The patient just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association. Case will be reevaluated based on follow-up information ,Linked Report(s) : US-PFIZER INC-2021001363 same reporter/drug/event, different patient.;US-PFIZER INC-2021001364 same reporter/drug/event, different patient.;US-PFIZER INC-2021001195 same reporter/drug/event, different patient.;US-PFIZER INC-2021001204 same reporter/drug/event, different patient.;US-PFIZER INC-2021001329 same reporter/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['Feeling abnormal', 'Feeling hot', 'Flushing', 'Immediate post-injection reaction', 'Palpitations', 'Tachycardia']",UNK,PFIZER\BIONTECH, 924927,MN,,F,"headache; body ache; chills; runny nose; sore throat; diarrhea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself; occupation/specialty: hospital worker) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on 30Dec2020 at 18:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient mentioned that the paper works she had stated that the side effects would start within an hour, but in her case, she experienced side effects over 24 hours that's Friday on 01Jan2021, such as headache, body ache, chills, runny nose, sore throat, and diarrhea. She wanted to know if she was infected with Covid, because of her job or she was having side effects because of the vaccine. The outcome of all the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/01/2021,2.0,UNK,,,,,,"['Chills', 'Diarrhoea', 'Headache', 'Oropharyngeal pain', 'Pain', 'Rhinorrhoea']",1,PFIZER\BIONTECH, 924929,AZ,81.0,M,"got symptoms of mild cold; running nose; cough; This is a spontaneous report from a contactable physician (patient). A 81-years-old male patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, unspecified route to administration on 23Dec2020 (at the age of 81-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension and mild diabetes Concomitant medication included nebivolol hydrochloride (BYSTOLIC), clonidine, hydralazine, losartan, nifedipine. The physician got symptoms of mild cold, running nose and cough in Dec2020. ""It just came a last two days and it's been cough and runny nose. I don't have a fever."" Outcome of the events mild cold, running nose and cough was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/01/2020,,UNK,BYSTOLIC; ; ; ;,,Medical History/Concurrent Conditions: Diabetes; Hypertension,,,"['Cough', 'Nasopharyngitis', 'Rhinorrhoea']",UNK,PFIZER\BIONTECH, 924930,,,U,"headache; feeling like having a temperature; was not high and it was 95; felt like tired; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number, expiry date were unknown) via an unspecified route of administration on 31Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 01Jan2021 almost like 11 o'clock, the patient started with headache and was feeling like having a temperature but when checked, temperature was not high and it was 95, the patient felt like tired. The patient stated ""I remember they said after you put in this, this is may be what happen. So, is it still in there is it still, so my question is can I take a some medicine or I need to wait till later with no medicine."" The outcome of the events headache, body temperature decreased, fatigue was unknown. Follow-up activities are possible, information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/01/2021,1.0,UNK,,,,,,"['Body temperature', 'Body temperature decreased', 'Fatigue', 'Headache']",UNK,PFIZER\BIONTECH, 924931,NJ,47.0,M,"Sore arm at injection site; Fever; Chills; body aches; This is a spontaneous report from a contactable physician (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on left arm on 21Dec2020 13:30 at single dose for COVID-19 immunization. Medical history included COVID-19 from Apr2020 to an unknown date and dust allergy. Concomitant medication included ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient experienced sore arm at injection site, fever, chills, body ache (mini COVID as compared to when he had COVID in early April) on 22Dec2020 03:00 (reported as 12-13 hours later). Symptoms controlled with Tylenol for about 15-20 hours. The patient underwent lab tests and procedures which included nasal swab on 09Dec2020, 14Dec2020, and 16Dec2020, results are all negative. The outcome of the events was recovered. Information about Lot/Batch number is requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYR,,Medical History/Concurrent Conditions: COVID-19; Dust allergy,,,"['Chills', 'Pain', 'Pyrexia', 'SARS-CoV-2 test', 'Vaccination site pain']",1,PFIZER\BIONTECH, 924932,CA,56.0,M,"Feeling of swelling in throat within 30 minutes of vaccine; This is a spontaneous report from a contactable physician (patient himself). A 56-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand Pfizer, lot EK9231, expiry date not reported), intramuscularly in the left arm on 02Jan2021 12:00 at single dose, for Covid-19 immunisation. Medical history included seasonal allergy and mild allergic rhinitis. There were no concomitant medications. The patient experienced feeling of swelling in throat within 30 minutes of vaccine, lasted 5+ hours, mostly by 9 hours on 02Jan2021. He took Singulair, Pepcid, Albuterol, Intranasal steroids and Phenylephrine as treatment. The outcome of event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Allergic rhinitis; Seasonal allergy,,,['Pharyngeal swelling'],1,PFIZER\BIONTECH,OT 924933,,,M,"extreme fever; chills; shortness of breath; This is a spontaneous report from a contactable physician (patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. Medical history included hospitalization due to COVID-19 (severe case several months prior but less than 90 days). The patient's concomitant medications were not reported. The patient experienced extreme fever, chills, and shortness of breath on an unspecified date. The clinical outcome of extreme fever, chills, and shortness of breath was recovered on an unspecified date. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,PVT,,,Medical History/Concurrent Conditions: COVID-19; Hospitalization (severe case several months prior but less than 90 days),,,"['Chills', 'Dyspnoea', 'Pyrexia']",1,PFIZER\BIONTECH, 924934,,,M,"green bret syndrome and he died from it; Initial information was received on 05-Jan-2021 regarding an unsolicited valid serious social media case from a consumer. This case is linked to case 2021SA003660 (same reporter). This case involves male patient (of an unknown age) who had green bret syndrome and he died from it (Guillain-Barre Syndrome) after receiving NFLUENZA VACCINE. Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed serious green bret syndrome and he died from it (Guillain-Barre Syndrome) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. On an unknown date, the outcome was reported as fatal for the event Guillain-Barre syndrome. It is unknown if an autopsy was done. The cause of death was reported as Guillain-Barre syndrome. Information on the lot number was requested.; Sender's Comments: This was a poorly documented social media case involves male patient (of an unknown age) who had Guillain-Barre Syndrome and died from it, after receiving INFLUENZA VACCINE. Time to onset is unknown. Additional information regarding patient's relevant medical history, health condition at the time of vaccination, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: green bret syndrome",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Death', 'Guillain-Barre syndrome']",UNK,UNKNOWN MANUFACTURER,OT 924939,IL,34.0,M,Left leg paresthesias. Isolated to lateral aspect of lower leg and stops at ankle. Has been ongoing for about 3 weeks off and on. It is intermittent and did go away for a week or so but recently returned. It has not progressed and appears to be localized.. Evaluated by neurology 1 week after symptoms with a normal neurological exam.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/18/2020,1.0,PVT,MVI,None,None,,Pcn,"['Laboratory test normal', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 924940,KS,17.0,F,"""Moderna COVID-19 Vaccine EUA"" Vaccine administered to wrong age patient. No known allergies or medical conditions. Nurse who administered vaccine did not know vaccine not approved for anyone under the age of 18.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,OTH,,,,,,['Product administered to patient of inappropriate age'],1,MODERNA,IM 924941,GA,55.0,F,About 30 minutes after shot - mouth dryness then slight difficulty swallowing. Took Benedryl and cleared up within the hour,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"AREDS 2, Centrium multivitamin, B12",cold,none,,only seasonal allergies,"['Dry mouth', 'Dysphagia']",1,MODERNA,SYR 924942,KS,45.0,F,Diarrhea Chills Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,Losa Losartan Potassium 25 mg 1 tab q daily Bupropion Hydrochloride XR 300 mg 1 tab q daily,None,Endometriosis,,NKDA,"['Chills', 'Diarrhoea', 'Pyrexia']",1,MODERNA,IM 924943,NY,34.0,F,"Fever, aches, headache, Tylenol and rest. Recovered after 1 day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 924944,GA,55.0,F,"Redness, small bumps, soreness and small lump at injection site that was not there the day before. Soreness is compared to the soreness at injection site shortly after getting the vaccine but a little worse.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,"AREDS 2, Centrium multivitamin, B12",cold,,,seasonal allergies only,"['Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site rash']",1,MODERNA,SYR 924945,VA,45.0,F,My right neck shoulder region started hurting approximately 7 hours after the vaccination and progressively increase in pain. I took Tylenol 1300mg on Tuesday evening. I woke up Wednesday morning with some discomfort and decided to take another dose of Tylenol 1300mg approximately 10:00 am. The pain increased and I took another dose of Tylenol 1300 mg approximately 1500. Tylenol was not relieving my discomfort and approximately at 1800 I took Celebrex 200 mg . I went to bed at 2200. Lying down was difficult. I could not turn my head from side to side without excruciating pain. I finally went to sleep. I woke up Thursday morning pain free.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Arthralgia', 'Mobility decreased', 'Neck pain']",1,MODERNA,IM 924946,NJ,29.0,F,"Onset of fever, chills, muscle aches/joint pain, headache 11 hours after injection. Fever, chills, and severe muscle aches/joint pain lasted for about 24 hours. Milder muscle aches and headache lasted for about 36-48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"Sertraline, Tretinoin, B-12, Lamisil",,"Hypertrophic cardiomyopathy, anxiety, depression, silent reflux",Muscle pain at injection site,,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924947,NH,53.0,F,"Dizziness muscle aches, chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,WRK,Levthyroxine lisinopril hctz norvasc,No,Bronchitis,,Vicodin codiene aspirin biaxin percocet,"['Chills', 'Dizziness', 'Fatigue', 'Myalgia']",1,MODERNA,IM 924948,FL,57.0,F,"40 minutes post shot - became extremely flush and hot; face and neck redness that lasted about an hr.. 8 hrs. post injection had extreme itching in upper body (stomach, arms, back and head). Also experiencing nausea and headache since onset of itching. Taking Benadryl, Pepcid and Zyrtec.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,"Multi Vitamin, morainga, tumeric",,,,Keflex; sulfa products,"['Erythema', 'Headache', 'Hot flush', 'Nausea', 'Pruritus']",1,MODERNA,IM 924949,ME,55.0,F,"Day 7 after vaccine, noted itching and swelling to left deltoid. Day 8 after vaccine, noted increased swelling, redness, itching and heat. Entire left deltoid area affected Day 9 after vaccine, redness extended past margins, itching and heat continued. Swelling subsided somewhat. Seen at Urgent Care. No medications received. Instructed to monitor and call for antibiotics next day if s/s continue or worsen Day 10 after vaccine, swelling subsiding, redness turning pink, continued with warmth and itching Day 11 after vaccine through today Day 14, itching continues, scab at site of injection noted.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/31/2020,7.0,PVT,"Dietary supplements: Mag/Ca, Berberine, Vit D, Probiotic, Omega, B-50 complex",None,Constipation,"Tetanus vaccine 2016, similar reaction however less severe",None,"['Injection site erythema', 'Injection site pruritus', 'Injection site scab', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 924950,PA,30.0,F,"Patient c/o dizziness, nausea, diaphoresis, tinitus. Patient states this occurs after every vaccination due to her fear of vaccinations/needles. Patient moved to a cot via wheelchair and placed in trendelenberg for approximately 30 minutes. Offered water, crackers. Symptoms resolved and she exited clinic without difficulty, accompanied by a friend.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,"Klonopin, Vibrax, B12, Apple Cider Vinegar",None,"Depression, Anxiety DO, PTSD",Same as episode in this report for any vaccination,Latex,"['Dizziness', 'Fear of injection', 'Hyperhidrosis', 'Nausea', 'Tinnitus']",1,MODERNA,IM 924952,OH,43.0,F,"diarrhea, headache,chills,sweats,nausea welt the size of a small orange that is red and hot with a rash",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"bumetanide, hydrochlorathyzide, synthroid",n/an/a,"hypothyroid, hypertension",,,"['Chills', 'Diarrhoea', 'Erythema', 'Feeling hot', 'Headache', 'Hyperhidrosis', 'Nausea', 'Rash', 'Urticaria']",2,MODERNA,IM 924953,NY,58.0,F,"On my way home, about 30 minutes after the vaccine, my throat became tight and my lips and tongue were tingly. At 4 pm I took a Benadryl. At 7pm I took a second one and went to bed at 7:30. In the morning these symptoms were gone",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Pravastatin 40mg, One a Day women's multi vitamin, Caltrate 600+D3, bid, Osteo Bi-Flex, bid, D3 50mcg, B12 500mcg.",,,,NKA,"['Paraesthesia oral', 'Throat tightness']",1,MODERNA,SYR 924954,MA,57.0,F,"Two hours after receiving the vaccine, I had extreme headache, this lasted for over 24 hours, after that the next 2 days was a lighter headache and some light brain fog feeling. The day after the vaccine had some mild chest pain, 5 minutes worth and than went away. Left arm hurt but just the usual with a shot. 6 days after vaccine, I had a rash and bump over my right ear, itchy arms and hands and neck area.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,Levothyroxin,None,"Hashimotos, Hypothyroidism",,None,"['Chest pain', 'Feeling abnormal', 'Headache', 'Pain in extremity', 'Pruritus', 'Rash']",1,MODERNA,IM 924955,PR,41.0,F,"Fever 104, chills, nauseas, swollen lymph's armpits, severe headaches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PUB,Phentermine,No,No,,None,"['Chills', 'Headache', 'Lymphadenopathy', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924956,,29.0,F,"Fever, severe chills for around 4 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,Taytulla,,,,,"['Chills', 'Pyrexia']",1,PFIZER\BIONTECH,IM 924957,NY,44.0,F,"Patient felt dizzy 30 minutes post injection, required extra observation and rest time to dissipate. She was slightly hypertensive 145/88 mm/Hg and 147/91 mm/Hg. Heart rate was consistently in the 80 BPM range.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,"Latex, Penicillins","['Dizziness', 'Hypertension']",1,MODERNA,IM 924958,NY,35.0,M,"Patient developed metallic taste in mouth post vaccination, gingerale helped to alleviate it.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,Penicillin,['Dysgeusia'],1,MODERNA,IM 924959,TX,29.0,F,A week after receiving the vaccine I woke up with hives like symptoms at the injection site (right arm) and on my chest. There is also a lump that developed on my right collarbone within the past two days.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,WRK,None,No,No,,"Dairy, gluten","['Injection site urticaria', 'Neck mass', 'Urticaria']",1,MODERNA,IM 924961,PA,49.0,F,"Swelling, redness, warmth at injection site 8 days after injection, began 01/07/21 and still currently present",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,"Fexofenadine, 180mg once daily Norethindrone, 1 tablet daily Multi-vitamin",Sinus infection,,,"Disperse blue Dog dander Tree, grass pollen Mold","['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 924962,IA,56.0,M,"Generalized fatigue, right knee pain and swelling. Muscle pain and weakness around right lower extremity.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,PHM,lorazepam,,high blood pressure,,,"['Arthralgia', 'Fatigue', 'Joint swelling', 'Muscular weakness', 'Myalgia']",1,MODERNA,IM 924963,OH,53.0,F,"Began with very painful and swollen injection site the first night. Tuesday during the day I took Tylenol and it helped. Tuesday evening I was hit with extreme chills and body aches. Injection site was very hot, painful, red and swollen. Stayed wrapped in a blanket for hours. Lasted into my sleep. Had a low temp in the morning on Wednesday (99.7) Seemed to have the"" sweats "" most of the day. Injection site was still hot, red and swollen. Today feeling better but injection site is still painful and has a mounded lump.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Metformin Atenolol pravastatin triamterene -hydrochlorothiazide omeprazole glipizide,none,diabetes hypertension high cholesterol tacacardia,,lisinopril,"['Chills', 'Hyperhidrosis', 'Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 924964,DE,51.0,F,Vertigo - started 2 hours after injection and lasted 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,None,none,None,,"Tea, honey, mushrooms, bactrim DS, neosporin, PCN",['Vertigo'],UNK,MODERNA,IM 924965,CT,33.0,M,"After the standard soreness after injection lasting approx 3 days, symptoms dissipated. At around 7 days post injection, acute onset of profound redness, swelling and pain was noted to the injection site. Now at 10 days, redness and swelling still present, however symptoms have decreased in severity. Now I have muscle twitching at the injection site as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,PVT,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Muscle twitching']",1,MODERNA,IM 924966,NY,18.0,M,Was nervous about getting the shot. Felt clammy and hot. Felt weak and had a headache. A Code was called and he was transported to the emergency room for monitoring.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Asthenia', 'Cold sweat', 'Feeling hot', 'Headache', 'Nervousness']",1,MODERNA,IM 924967,CT,33.0,F,"7 days after, sore arm, red rash approximately size of palm of hand, warm to touch,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,,None,None,,None,"['Feeling hot', 'Pain in extremity', 'Rash erythematous']",1,MODERNA,SYR 924968,FL,41.0,F,woke up 1/6/21 @ 4am with chills and nausea. Took a Zofran. Awoke again at 5am with fever of 100.6 F. Fever did not respond to 600 mg ibuprofen. Later that day developed headache and body aches. Pain at injection site present as well.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,none,rhino virus,none,,Sulfa drugs,"['Chills', 'Headache', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924969,SD,54.0,M,Rapid onset chills 103 temp injection site tenderness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,rosuvastatin 10 mg tablet aspirin 81 mg Multi vitamin,n/a Healthy. Feeling good,mild hypercholesterolemia,,,"['Chills', 'Injection site pain', 'Pyrexia']",1,MODERNA,SYR 924970,SC,34.0,M,"Right testicular pain, diagnosed R epididymititis, treated with levaquin 500 gm qd x10d",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,MIL,amlodipine,none,HTN,,NKDA,"['Chlamydia test', 'Culture urine', 'Epididymitis', 'Gonorrhoea', 'Testicular pain', 'Urine analysis']",1,MODERNA,IM 924971,PR,52.0,M,RASH IN THE LEFT ARM WHERE THE THE VACCINE WAS ADMINISTER. THE EMPLOYEE TAKE ZYRTEC FOR TWO DAYS,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,LISINOPRINE 10MG,NONE,HIGH PRESSURE,,NONE,['Vaccination site rash'],2,PFIZER\BIONTECH,IM 924972,MA,45.0,F,Chills and body aches for 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,none,none,none,,none,"['Chills', 'Pain']",UNK,MODERNA, 924973,TX,37.0,F,5 mins after injection heart rate increased ton170 and blood pressure increased to 180/00 showed no signs of anxiety. Symptoms subsided within 2 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,Tramadol 50mg,Recently had food poisoning,"Sick sinus syndrome, NAFLD, sarcoidosis, cardiac pacemaker",,Demerol and sulfa,"['Blood magnesium', 'Blood pressure increased', 'Electrocardiogram', 'Full blood count', 'Heart rate increased', 'Immediate post-injection reaction']",1,MODERNA,SYR 924974,IN,26.0,F,"on 7th day post vaccination, I had left upper arm swelling, rash, and pain where there had previously been none. Freckles on that upper arm scabbed over and peeled. This event lasted less than 2 hours. No medications taken, no medical care received. No further reaction since then.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/27/2020,7.0,OTH,"lexapro 10mg oral birth control pill, daily",none,anxiety,,none,"['Injection site pain', 'Injection site rash', 'Injection site scab', 'Injection site swelling', 'Skin exfoliation']",1,PFIZER\BIONTECH,IM 924975,FL,64.0,F,"fever, chills, headache, muscle and joint pain, duration 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,none,none,none,,none,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 924976,KS,58.0,F,"Eight days after shot given woke up with severe headache. About noon that day my left arm started itching real bad and was itching it. One of the nurses I work with said there was welts on my skin. I could feel 3 lumps and was warm to touch and red. I notified my supervisor and was told to contact my doctor's office. They called me later and told me to take anti-histamine and cool compress to the area, which I did. Was very tired and went to bed early.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,WRK,"Centrum Silver daily multivitamin Sertraline 50mg daily Nabumetone 750mg 2 daily Take HUMIRA INJECTION 40 SQ bi weekly and did so on January 1st, 2021",Psoriatic Arthritis and preparing for a right knee revision on January 18th of 2021,"Psoriasis, Psoriatic Arthritis",,Sulfa medications cause skin rash,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site pruritus', 'Injection site warmth', 'Urticaria']",1,MODERNA,SYR 924977,,41.0,F,Developed weals on chest and Back. took anti- histamine and condition resolved,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,,,,,,['Urticaria'],UNK,MODERNA, 924978,VA,32.0,F,Decreased range of motion and pain to shoulder since vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,Xyzal,none,none,,Seasonal allergies,"['Arthralgia', 'Joint range of motion decreased']",1,MODERNA,IM 924979,VA,54.0,F,"Rash (pruritic) was first noticed the morning after injection. Started on one wrist and expanded throughout arm. Started the same way on the other arm a few hours later. By the evening, the rash encompassed both arms and started at both ankles. After 24h, the rash was over all 4 extremities. Took benadryl (50mg once) without effect on rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,WRK,"Supplements - calcium, MG, MVI",spider bite one month prior occipital neuralgia due to spider bite,None,,Sulfa Questionable tetracycline,['Rash pruritic'],1,PFIZER\BIONTECH,IM 924980,GA,37.0,F,"chills, sweating, tachycardia , leg cramps, headache,back and neck ache evaluated in ED, EKG, IV fluids, dehydration, elevated ketones 01/5/2021 03:30am 01/07/2021 Reported Feeling better, discomfort in lymph nodes under arm , Temp 99.. sweating, HR +80",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,IUD,none,none,,"sulfa, seasonal allergies","['Axillary pain', 'Back pain', 'Chills', 'Electrocardiogram normal', 'Headache', 'Hyperhidrosis', 'Lymph node pain', 'Muscle spasms', 'Musculoskeletal discomfort', 'Tachycardia', 'Urine ketone body present']",2,PFIZER\BIONTECH,IM 924981,OH,41.0,F,"I received Vaccine on 12/23/2020. On 12/30/2020 I started to get a red welt on my arm at the site of the injection. It was warm to the touch but didn't hurt really bad. Thursday the 12/31/2020, the welt got bigger and warmer, I started to draw lines around the redness and monitor the progress, each day it grew a bit bigger. Started itching and burning. I took motrin and used ice on this. I don't use OTC medicated stuff as I am allergic to a lot of it, and seemed like it was cellulitis. Monday 1/4/2021, I got to work my arm was just red, inflamed and I was just miserable, the redness and pain were worse, painful to touch. I went to a walk in clinic that told me they suspected cellulitis, and gave me prednisone, and Keflex. I continued to ice the area, it started to feel better late Tuesday 1/5/2021 & redness went down. I have pictures if this is helpful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PVT,"Collagen, vitamin C, Vitamin D, Ashwagdha Root, Lexapro, Depakote, Ajovy, Amitriptyline, Eliquis, Vitamin B12, Calcium, Magnesium, Zinc.",No,"Depression, headaches.",,"Neosporin, Bactroban, (contact Dermatitis) Levaquin, and Erythromycin.","['Cellulitis', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Urticaria']",1,MODERNA,IM 924982,SC,49.0,F,Pain in the arm of injection that lasted for 2 days and 1 week later armpit pain which is still hurting as of 1/7. Can't feel any swelling of lymph nodes. This also occurred in the arm of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PHM,"Metoprolol xl, levothyroxine,pantoprazole,vit d,fiber gummies,ester c, fish oil,probiotic",No,Hypothyroidism,,Some ingredient in Delsym,"['Axillary pain', 'Pain in extremity']",1,MODERNA,IM 924983,MA,45.0,F,"Woke up in night sweats, nausea, severe headache with neck and back pain. right shoulder pain and tingling right hand.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,WRK,Lexapro - 5 mg Calcium with Vitamin D Vitamin C Omeprazole,None,anxiety disorder,,wellbutrin augmentin Penicillin almonds snow peas,"['Back pain', 'Headache', 'Injection site pain', 'Nausea', 'Neck pain', 'Night sweats', 'Paraesthesia']",1,PFIZER\BIONTECH,SYR 924984,NH,23.0,F,First symptom was pain in my arm. Then I spiked a low grade fever. Then I got nauseous. Around 7pm I vomited and at 3:30 am I aggressively dry heaved. Throughout the whole time my arm was in pretty serious pain and still is. I woke up this morning and my fever got worse. Nausea still but so far no vomiting.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2020,01/06/2021,366.0,UNK,Birth control.,None,"Asthma, SIBO",Pertussis at age 2. Sever swelling in leg of injection,"Sulfa, pertussis","['Nausea', 'Pain in extremity', 'Pyrexia', 'Retching', 'Vomiting']",1,MODERNA,IM 924985,NY,47.0,F,"Vaccine 12/28; 1/2- had stuffy nose; 1/3-had runny nose and cough; 1/4- had increased shortness of breath, dry cough, diarrhea, and loss of taste/smell; body temp fluctuated between sweating and cold on 1/3 and 1/4, but no fever; Reported symptoms at PCP visit on 1/4- COVID test done, but still pending",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/02/2021,5.0,PVT,,,,,,"['Ageusia', 'Anosmia', 'Cough', 'Diarrhoea', 'Dyspnoea', 'Hyperhidrosis', 'Nasal congestion', 'Nasopharyngitis', 'Rhinorrhoea', 'SARS-CoV-2 test']",UNK,MODERNA,IM 924986,TX,29.0,F,"Fever to 101.4F, headache, nuchal ridigity, tachycardia low 100s, nausea, muscle aches, extremely sore arm with injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,Spironolactone 25mg,None,None,,None,"['Headache', 'Myalgia', 'Nausea', 'Nuchal rigidity', 'Pain in extremity', 'Pyrexia', 'Tachycardia']",2,PFIZER\BIONTECH,IM 924987,MI,33.0,M,I sat in a chair after I received the vaccine. After 10 minutes I stood up and my legs were tingling and felt heavy. I was slightly lightheaded too. I sat back down for a few more minutes and then I went back to work. The the tingling stopped but my legs felt heavy for 3 days. I am feeling normal now. I am aware of orthostatic hypotension and the possibility of it being from sitting in the chair and pinching nerves. I just wanted to report this in case it is a problem.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Lisinopril 40mg, Amlodipine 2.5mg, Fish Oil 1200mg(2 capsules twice a day), Pepcid 20mg daily, vitamin D2 50,000 units Monthly(taken Wednesday December 30,2020) and Allopurinol 200mg daily",None,"IgA Nepheopathy, Hemachromatosis, Hypertension, high Uric acid level-currently all controlled",,NKA,"['Dizziness', 'Limb discomfort', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 924988,MA,59.0,F,nausea- onset within 10 minutes of vaccine. Ongoing vomiting- one instance 24 hours after vaccination diarrhea- onset 6-8 hours after vaccination. Ongoing mild headache- intermittent. ongoing,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,None,Sinus infection. Treated successfully with 10 days Doxycycline,none,,No known allergies,"['Diarrhoea', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 924989,AL,49.0,F,"Headache , joint pain, body aches, fever 100.4, soreness and redness at the injection site 24-48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,Protonix Zyrtec Claritin Womens health Glucosamine Chondroitin turmeric Cymbalta Zoloft,none,Osteoarthritis Anemia Elevated WBC,,Bactrim Percocet Penicillin,"['Arthralgia', 'Headache', 'Injection site erythema', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,SYR 924990,NY,28.0,F,"Patient complained of dizziness, numbness to fingers and toes, blurred vision. Patient anxious. Vital signs taken and stable. Fingerstick 137.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,No Known Allergies,"['Anxiety', 'Dizziness', 'Hypoaesthesia', 'Vision blurred']",1,MODERNA,IM 924991,,30.0,F,Patient c/o diarrhea and fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,WRK,unknown,unknown,unknown,,none reported,"['Diarrhoea', 'Fatigue']",1,MODERNA,IM 924993,NY,25.0,F,Hot Flashes lasting 2 days. Sweating profusely lasting 2 days. Arm Soreness/pain lasting 3 days - 500mg Acetaminophen q4-6hours PRN Headache 45 mins after injection - 500mg Acetaminophen Fatigue lasting 3 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,WRK,Zyrtec 20mgs,None,None,,NKDA,"['Fatigue', 'Headache', 'Hot flush', 'Hyperhidrosis', 'Pain in extremity']",1,MODERNA,IM 924994,OH,46.0,F,"Rash, Swelling, redness at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,WRK,multivitamins and elderberry,None,None,,None,"['Injection site erythema', 'Injection site rash', 'Injection site swelling']",1,MODERNA,IM 924995,CT,48.0,M,"Right hand falls asleep multiple times per day....fairly certain not from sleeping on it or otherwise. Numb, tingly sensations in right hand and wrist area.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,SCH,"Lisinopril, Metaprolol, Fluoxetine HCL, Montelukast",None,Asthma,,Naproxen,"['Hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 924996,DE,43.0,M,"H/A, High blood pressure, Nausea, Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,Vitamins,None,None,,None,"['Fatigue', 'Headache', 'Hypertension', 'Nausea']",UNK,MODERNA,IM 924997,NC,39.0,F,"Joint and Muscle pain, Fatigue, headache and soreness at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Synthroid, Armor and Creon",None,"Graves, Hashimoto",,"Erythromycin, morphine","['Arthralgia', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia']",1,PFIZER\BIONTECH,IM 924998,OH,32.0,F,"Redness, swelling, itching at injection site that developed on day 7 post vaccination (with vaccine administration being day 0). The affected area is approximately 1.5 inches x 2 inches in diameter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,Prenatal multivitamin,None,"Hypothalamic amenorrhea, infertility",,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 925000,GA,35.0,M,"left arm into neck pain, headache, low grade fever, nausea, body aches, treated with rest 01/07/ still has headache",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,none,none,none,,none,"['Headache', 'Nausea', 'Neck pain', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925002,CA,31.0,F,Low back pain Bodyache Injection site pain,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Back pain', 'Injection site pain', 'Pain']",UNK,PFIZER\BIONTECH, 925003,NC,57.0,F,"Bell?s Palsy upon waking, minor",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,Spironolactone Hydroxichoroquine Levothyroxine Tylenol Benadryl Magnesium Vitamin C Vitamin D Zinc Zyrtec,Migraine Seasonal allergies Plantar fasciitis Foot neuroma,Dermatomyositis,,Penicillin Sulfa Codeine,['Facial paralysis'],1,MODERNA,SYR 925004,IL,26.0,M,Moderna COVID-19 Vaccine EUA Body shakes (first 10 hours) Joint soreness (first 24 hours) Muscle weakness (since injection) Body sweats (12 hours post shot to 24hours post) Temperatures over 100 (Since 4pm day of shot) Piercing headache (since 4pm day of shot) No appetite (since 4pm day of shot),Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PUB,,,,,,"['Arthralgia', 'Decreased appetite', 'Headache', 'Hyperhidrosis', 'Muscular weakness', 'Pyrexia', 'Tremor']",1,MODERNA,IM 925005,FL,47.0,F,"Starting 6 hours after the vaccine was given, I had severe pain that lasted for 3 full days and prohibited me from moving my arm. It felt like my shoulder was broken. The pain has mostly subsided, but I still do not have full range of motion. In fact, I cannot take off my own shirt, because I can't do the movement of pulling and lifting my shirt over my head. It hurts, but at the same time feels like a pressure point that limits the movement. Heat seems to make it feel better for a few minutes, as well as deep tissue massage - but this only lasts for a few minutes. I feel handicapped. At this point I DO NOT want the 2nd dose because it could injure my shoulder more. And I don't want it in my other arm for fear of having two arms that I can't use.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,"Vitamin D, Vitamin C, B-complex",None,None,,No Known Allergies,"['Joint range of motion decreased', 'Pain', 'Vaccination site movement impairment']",1,MODERNA,IM 925006,VA,52.0,F,after 1 week of getting the vaccine. My left arm at the injection sight. Is red going down my arm and hot to touch,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,Cozaar 50mg Norvasc 5mg,,High Bp Celiac Disease,,Penicillin Sulfa,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,IM 925007,VA,43.0,F,"Immediately after injection I began feeling soreness and injection site. For the next 7 days I experienced erythema, edema - quarter sized, itchiness, and warmth at the injection site. Day 8 the itchiness was worse. Day 9 the area is erythematous and edema- the size of an open hand, warmth to the entire are, itchiness to area and my 1st and 2nd digits of my right hand. My colleague examined the area upon arrival to the clinic 1/7/2021 determined it was infected and provided an Rx for antibiotics.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,PVT,"HCTZ, Metoprolol, Venaflaxine",None,"HTN, Depression",,Latex,"['Immediate post-injection reaction', 'Infection', 'Injection site erythema', 'Injection site oedema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 925008,FL,44.0,F,"Reddened 2 inches diameter. inflamed, itchy, warm at injection site. Started out smaller. Started Claritin 1/6/21. Less reddened 1/7/21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,Armour thyroid,Na,Hashimotos,,Biaxin=hives Levothyroxine=rash,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 925009,MA,37.0,F,Low grade temp 100.2 Body aches Chills Headache Metallic taste in mouth Pain and bruising in Right arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,Atorvastatin,None,High cholesterol,Localized cellulitis from flu vaccine 2010,"Dilaudid- adverse reaction, dizzy, lightheaded, weak. Flu vaccine 2010- cellulitis","['Chills', 'Contusion', 'Dysgeusia', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 925010,IA,42.0,F,"Moderna COVID-19 Vaccine EUA Itching, hot, red swollen, raised area of about 8 inches by 4 inches on arm injection site. Took benadryl and put ice on it. Lasted about 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,PVT,Citalopram 10mg Cetirizine 10 mg,,,,Augmentin Bactrim Clindamycin Lamisil,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 925011,FL,51.0,F,"I woke in the morning with nasal congestion. Around 0800 I started with fatigue and malaise. At 1000 I had a temperature of 100.4, took Tylenol 500 mg, and laid down. I got up an hour later feeling fine. Around 1600 hours I felt malaise again and warm. I checked my temperature and it was 100.2. I took Tylenol 500 mg again. I went to bed at 2030 and woke Friday morning feeling completely normal. All of the symptoms had resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Multivitamin, Synthroid 125 mcg, Atorvastatin 10 mg, Vitamin D, Claratin, Fish OIl",None,Hypothyroidism,,"Latex, Seasonal allergies","['Fatigue', 'Malaise', 'Nasal congestion', 'Pyrexia']",1,PFIZER\BIONTECH, 925012,FL,23.0,F,"Moderna COVID-19 Vaccine EUA The day of the vaccine, I was fine besides my arm hurting- the one I got the shot in. That night I went to sleep at 830PM. I woke up a little before 1030PM shaking with chills and nauseated. I couldn't sleep the whole night, going between sweating and shaking. The next day 1/6/21 I was still unwell, didn't go into work, felt weak and sore the whole day and noticed my underarm of the arm I received the shot was swollen and painful,. Today 1/7/21, my underarm is still painful and swollen, but the nausea has subsided. Still slightly going between sweating and being chilled.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Wellbutrion xl 300mg Femynor (oral contraceptive) magnesium 300mg probiotic ashwaganda,none,none,flu vaccine- sore arm,none,"['Asthenia', 'Axillary pain', 'Chills', 'Hyperhidrosis', 'Injection site abscess', 'Malaise', 'Nausea', 'Swelling', 'Tremor']",1,MODERNA,IM 925013,NY,35.0,F,Patient went home after vaccination. Patient took Nyquil with Benadryl at home. Felt mouth numbness and came back to vaccine Pod. Patient evaluated by Resident. Symptoms improved. Vital signs taken.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,,,,No Known Allergies,['Hypoaesthesia oral'],1,MODERNA,IM 925014,MI,28.0,F,Moderna COVID-19 Vaccine EUA,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,SEN,"Birth control (Larissia), cetirizine, multi vitamin, Ibuprofen",Had COVID-19 a month and 7 days prior of the vaccination,None,,None,['Unevaluable event'],1,MODERNA,SYR 925015,NC,56.0,F,"12/29/2020 swollen, red, pain and heat at injection site. Redness has expanded to 6 in long and wide with huge knot. Pt has felt fatigued",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,"Ambien selca, vitamin C, Miralax, vitamin D, Protonix, Azathioprine",,,,,"['Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 925016,OH,59.0,F,"Chills, fever,. slight headache, extreme exhaustion",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,vitamin C Vitamin D Vitamin# Fish oil Calcium,,,,Bactrim,"['Chills', 'Fatigue', 'Headache', 'Pyrexia']",UNK,MODERNA, 925017,RI,40.0,F,"Redness, pain, lump and itchiness at injection site. This went away after 3-4 days. On day 8 after injection all symptoms returned specifically at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2019,12/30/2019,1.0,WRK,omeprazole,none,none,,allergic to sulfa drugs,"['Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,SYR 925018,PA,52.0,F,Approximately 20-30 minutes after receiving the vaccine I noticed around my eyes and upper lip was tingling and felt numb. I continued to close up my desk to leave work for the day thinking it would just go away in few minutes. When I got to my vehicle I took two Benadryl capsules and drank a bottle of water and waited nearby the hospital emergency department parking area for 30 - 40 minutes. The numbness had eased and I drove home. Tuesday and today (Wednesday) I have felt very tired and fatigued.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Blepharospasm', 'Fatigue', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 925019,GA,48.0,F,"Fever (100.8 F), chills, headache, body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,WRK,Calcium,I had COVID. Symptoms started on 12/9.,None,,None,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 925020,MN,52.0,M,"I started feeling bad in my body. This morning when I was come home and go to bed to sleep, I had a fever. I do not know which Covid vaccine I received. Today when I go to work, I am going to go to the ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,No,No,No,,No,"['Malaise', 'Pyrexia']",UNK,PFIZER\BIONTECH, 925021,NJ,25.0,F,"Nausea, fever of 101.4, headache, soreness in arm of insertion site. Treated with Tylenol. Resolved within 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"nortriptyline, oral birth control, vitamin c, probiotics, multivitamin, cranberry tablet, biotin, vitamin b complex, melatonin, apple cider vinegar",N/a,Tension headaches,,N/a,"['Headache', 'Injection site pain', 'Nausea', 'Pyrexia']",1,MODERNA,IM 925022,NY,30.0,F,"Woke up on day 8 after getting vaccine with large warm lump on left arm all around the injection site Warm to touch, red and looks irritated",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/06/2021,8.0,PVT,None,None,None,,None,"['Injection site erythema', 'Injection site irritation', 'Injection site mass', 'Injection site warmth']",1,MODERNA, 925023,GA,42.0,F,"I had previous diagnosis of COVID-19 in September 2020. No one asked me that question prior to vaccination. After the vaccination, I had a fever for 1.5 days, muscle aches, weakness, nausea, diarrhea, headache, fatigue, cough. I had a rash that appeared after I got COVID-19, the rash never went away. After the vaccination, the rash became redder, enlarged, and spread.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,Cymbalta MVI Birth Control Pills,None,"I had Covid-19 around Sept 1st, 2020",,Wellbutrin,"['Asthenia', 'Cough', 'Diarrhoea', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Rash']",1,PFIZER\BIONTECH,IM 925024,,59.0,F,headache; chest tightness and cough. Albuterol for Rx. Started later same day and still present; No other allergic signs Tested subequently for COVID 19 by PCR and negative,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,tamoxifen,,,,nkda,"['Chest discomfort', 'Cough', 'Headache', 'SARS-CoV-2 test negative']",1,MODERNA,IM 925025,WV,64.0,M,"EE had COVID vaccine at approx 10:20a today. EE reports to EH with rash on abd. and arms. Denies SOB, facial swelling, o2 sats 96%, P 72.BP 116/62. 25 mg Benadryl given at 1350. Released from EH at 3p, EE cont. to deny SOB or other sx. Rash ?less hot?. EE to report to UC or ER if sx worsen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,['Rash'],UNK,PFIZER\BIONTECH,IM 925026,OK,76.0,M,"Having Peeing / semi diarrhea problems. Lucky I had a catheter with me; first time needed in a year. Semi diarrhea was something new. Did not eat anything after breakfast, fruit as usual that morning. Bad Headache went away after 48 hours. Felt good after that. Had no fever, ever.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,Avodart,none,none,,none,"['Diarrhoea', 'Headache']",1,MODERNA,IM 925027,VA,51.0,F,Had body aches and fatigue for 4 days. Sore throat developed after second day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/29/2020,6.0,WRK,"Multi vitamin, Vitamin D3 5000 IU",None,"Raynaud's disease, pre-diabetes",,Naproxen - anaphylaxis Ibuprofen - GI bleed,"['Fatigue', 'Oropharyngeal pain', 'Pain']",1,PFIZER\BIONTECH,IM 925028,MD,31.0,F,"About 15-30 mins after injection, hives, rash, itchiness. I was given 25mg of Benadryl. Symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Lamictal, spirnolactone, buspar, probiotic, metformin, birth control, klonopin",GI disturbance,"Asthma, depression, anxiety, pcos",,"Chg, Wellbutrin, celexa","['Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 925029,KY,29.0,M,"severe pain, swelling in arm, numbness in arm and neck",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,none,none,none,,none,"['Hypoaesthesia', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,SYR 925030,CT,22.0,F,Fever of 100� beginning 6 hours after injection and lasting for 10 hours before declining to a 99� fever. Stiff neck and headache radiating from the base of the skull. Excessive pain in the injection arm. General achiness throughout the body. Nausea and fatigue.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Aczone, Trentinoin, Doxycycleine",Chlamydia,Asthma,,"Sulfa based medication, penicilin based medication","['Fatigue', 'Headache', 'Injection site pain', 'Musculoskeletal stiffness', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 925031,VA,56.0,F,Round red rash at injection site with swelling has appeared 1.5 weeks after the vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,UNK,"Calcium, multi vitamin, vitamin C, Vitamin B12",none,none,,tetracycline,"['Injection site erythema', 'Injection site rash', 'Injection site swelling']",UNK,MODERNA, 925032,TX,35.0,M,"Unilateral left conjunctivitis began 1/5/2021, began presumptive treatment with antibacterial eye drops 1/6/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,UNK,None,None,NOne,,NKDA,['Conjunctivitis'],1,PFIZER\BIONTECH,SYR 925033,AL,45.0,F,"SEVERE PAIN IN ARM & NECK FOLLOWED BY BODY ACHES, CHILLS, FEVER AND FATIGUE.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,,NONE,NONE,,PENICILLIN,"['Fatigue', 'Neck pain', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 925034,MI,52.0,M,Patient developed Bell's Palsy on 1/1/2021 and was seen in the Emergency department and started on oral steroids. I saw him 1/6/2021 and he continued to have left sided facial nerve palsy/paralysis.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/01/2021,9.0,PVT,"levothyroxine, amlodipine, fenofibrate, hydrochlorothiazide, rosuvastatin, losartan, aspirin, fish oil, vitamin D3, metformin.",none,"Hypertension, hypothyroidism, hyperlipidemia, type 2 diabetes",,"lisinopril, codeine","['Electrocardiogram normal', 'Facial paralysis', 'Full blood count normal', 'Laboratory test normal']",1,PFIZER\BIONTECH,IM 925035,,48.0,M,woke up this morning feeling slight numbness on my left cheek. The sensation is very similar to when I receive a numbing shot from my dentist for dental work. The feeling of numbness comes and goes with varying levels of intensity. Sometimes twitching my cheek can make it go away; but it keeps occurring.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/07/2021,7.0,PVT,,,,,,"['Hypoaesthesia', 'Muscle twitching']",UNK,PFIZER\BIONTECH, 925036,TX,36.0,F,"C/o aches, chills, headache and fever that began the next morning at 6:00 am after receiving the vaccine. Treatment include Advil.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925037,RI,59.0,F,"9 hours post injection: fever. 20 hours post injection: chills, fever, body aches, malaise, headache. Body aches lasted 36 hours. Fevers lasted 48 hours. Headache lasted 120 hours. Other symptoms lasted72 hours. Face still feels hot 5 days later.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,OTC Magnesium and Multi Vitamin supplements,"Recovered from Covid-19 on Dec. 14th, 2020",Osteoporosis (not treated with medication),,Similar reaction to Boniva,"['Chills', 'Feeling hot', 'Headache', 'Malaise', 'Pain', 'Pyrexia']",1,MODERNA,IM 925038,PA,54.0,F,Moderna COVID-19 Vaccine EUA gastrointestinal upset/diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/25/2020,3.0,PVT,Lexapro Multivitamin menopause support,none,anxiety,,none known,"['Abdominal discomfort', 'Diarrhoea']",1,MODERNA,IM 925039,MN,59.0,F,SOB started Saturday 01/02/2021 continued SOB Sunday 01/03/2021 and on Monday 01/04/2021 went to clinic and saw a provider. Resulted in bilateral pulmonary emboli treated with Lovenox and Coumadin.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,WRK,,,,,,"['Computerised tomogram abnormal', 'Dyspnoea', 'Pulmonary embolism']",UNK,PFIZER\BIONTECH, 925040,NY,33.0,F,"red/raised/itchy rash to left deltoid, ~10cm/5cm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,PVT,"Levothyroxine 75 mcg PO daily, vitamin D 2,000 IUs daily",none,Hashimoto's thyroiditis,,none,"['Erythema', 'Peripheral swelling', 'Pruritus', 'Rash']",1,MODERNA,IM 925041,NM,56.0,M,"At 01:30, 1/7/21, I developed Extreme chills, then body became hot but temperature was normal, At around 02:30, my whole body ached with a sharp pain just above my right wrist and a sharp pain at the ball of my right foot. It's 07:05 right now and still have body aches, pain in right foot and right wrist.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,"Rosuvastatin 5mg, Metoprolol 100mg, Metformin 500mg, Bayer 81mg, Multivitamin, Fish Oil 2000mg, D3 25mg, B12 1000mg and A 2400 mg. Omerprazole 20mg and cholestyramine 4gram",None,2 dissecting Superior mesenteric artery,,Certain fruits and cat scan contrast,"['Arthralgia', 'Chills', 'Feeling hot', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 925042,OH,26.0,F,Tachycardia-heart rate 148 for 45 minutes Metallic taste in mouth Lower abdominal pain (cramp like),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Birth control-Junel fe,,,,Allergic to tree nuts,"['Abdominal pain', 'Dysgeusia', 'Tachycardia']",1,MODERNA,IM 925043,MI,52.0,M,Patient developed left side Bell's Palsy 8 days after receiving vaccine. He was seen in the Emergency Department and started on Prednisone,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/01/2021,9.0,PVT,"amlodipine, aspirin, Vitamin D3, fenofibrate, hydrochlorothiazide, levothyroxine, losartan, metformin, fish oil, rosuvastatin,",None,"Diabetes, Hypertension, hyperlipidemia, hypothyroidism",,"codeine, lisinopril","['Electrocardiogram', 'Facial paralysis', 'Full blood count normal', 'Metabolic function test']",1,PFIZER\BIONTECH,IM 925045,NJ,31.0,F,"Had initially had heaviness in chest but tolerable. Injection site was red with bump for 2 days, then resolved. evening of 1/6/21 itchiness returned to injection site and now today 1/7/21 injection site has a warm, red itchy area that is 50 mm in diamter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/30/2020,29.0,OTH,just takes vitamins and cetrizine 10mg routinely. diphenhydramine 25mg because history of allergy reactions. took all on day of vaccination,none,none,similar itchiness with hot red bump on arm after flu shots x 2-3 days,has rash like reaction to flu shots but does ok with FluBlok,"['Chest discomfort', 'Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 925046,OH,35.0,M,"It was reported that ""the vaccination leaked half way out of his arm. """,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,N/a,,,,No known medication allergies,['Incorrect dose administered'],UNK,MODERNA, 925047,TX,40.0,F,"rash on arms and torso; shortness of breath, and body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,Tylenol for fever and aches Benadryl for rash Mulitvitamin,No,No,,amoxicillin augmentin zithromax,"['Dyspnoea', 'Pain', 'Rash']",2,PFIZER\BIONTECH,IM 925048,VA,31.0,F,My lymph nodes under my right arm is swollen and tender. The pain started Tuesday 1/5/2020 around 8am,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Iron and B-12 pills over the counter,none,Anemica,,none,"['Lymph node pain', 'Lymphadenopathy']",UNK,MODERNA, 925050,TX,19.0,F,"My arm became incredibly sore within an hour. I woke up in the middle of the night aching like I had the flu. The body aches were so intense I couldn?t dress myself in the morning. All of my lymph nodes in my neck, ribs, and collar bones were incredibly swollen and hurt when touched. I rotated Tylenol and Advil with no relief. My fatigue was like no other. My headache wouldn?t go away either. 48 hours after the vaccine, I still had body aches and swollen lymph nodes in my neck to the point of pain when turning my neck.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Allegra 180 BID, Alyacen QD, Metoprolol 25mg QD, Lexapro 10mg QD",Mast Cell Activation Syndrome suspected by immunologist,,,Sulfa,"['Fatigue', 'Headache', 'Lymph node pain', 'Lymphadenopathy', 'Neck pain', 'Pain', 'Pain in extremity']",1,MODERNA,IM 925051,FL,48.0,F,I started with palpitations lasting for approximately half an hour reaching 122. I took Motrin 800 mg after I got the vaccine by that evening about 11 o?clock I started getting chills and I started spiking fevers very uncomfortable muscle muscle aches bodyaches frontal headache fatigue x 2 days. I still have body aches and joint pain with a mild frontal headache,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,Eliquis Uptrava Adcirca Letaris Leyothyroxine Toprol,None I was dx with covid on June 22 and had it for 6 weeks.,ASD with pulmonary hypertension,,Nkda,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Pain', 'Palpitations', 'Pyrexia']",1,MODERNA,IM 925052,OH,46.0,F,"The morning after the vaccine , I experienced extreme fatigue, achy, muscle soreness. Tylenol provided some relief but then wore off after about 5 hours. Still achy, muscle soreness the 2nd day after. I was diagnosed with COVID end of Nov.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Cymbalta,Diagnosed with COVID on 11/30/2020,None,,None,"['Fatigue', 'Myalgia', 'Pain']",1,MODERNA,IM 925053,CT,27.0,F,Extreme fatigue (slept for 2 days straight) and some nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,Enbrel injection Synthroid 50 mcg Balcoltra birth control,None,"Rheumatoid arthritis, lupus",,No known allergies,"['Fatigue', 'Nausea']",1,MODERNA,IM 925054,SC,31.0,F,"Painfully swollen axillary lymph nodes on side of injection, painfully swollen cervical lymph nodes bilaterally, nausea, headache. Did not have any other symptoms and did not feel it warranted a dr appointment. Read the covid19 vaccine information sheet and saw all were known side effects. Resolved by 12/21/2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/18/2020,2.0,WRK,"Adderall 15mg XR, oral contraceptive",none,,,"latex, kiwi","['Headache', 'Lymph node pain', 'Lymphadenopathy', 'Nausea']",1,PFIZER\BIONTECH, 925055,TX,32.0,F,on day 7 during the day my arm start itching around injection site and area around started swelling. Today (day 8) area is more swollen but doesn't really itch.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,PUB,"Claritin, vitamins- c and d",,,,not that I know of,"['Injection site pruritus', 'Injection site swelling']",UNK,MODERNA, 925056,CT,55.0,F,Fever of 101.4 and Body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Sertraline and estradiol,None,None,,No,"['Pain', 'Pyrexia']",1,MODERNA,UN 925057,,30.0,M,"Globus sensation, throat swelling but able to breath, talk and keep water down. 20-30 mins after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,None,None,None,,None,"['Pharyngeal swelling', 'Sensation of foreign body']",1,PFIZER\BIONTECH,IM 925058,OH,35.0,M,"It was reported that ""the vaccination leaked halfway out of his arm.""",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,N/a,,,,No reported allergies to medications.,['Incorrect dose administered'],1,MODERNA, 925068,PA,43.0,M,shingles on v1 verve,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,PHM,"irbesartan 300, fexofenadine 180, amlodipine 10, atorvastatin 20, basaglar, novolog",none,"htn, insulin dependent diabetic",,lisinopril (angioedema),['Herpes zoster'],1,PFIZER\BIONTECH,IM 925069,IL,48.0,M,"15 hours after the vaccine I came down with fever, headache, chills, and body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Metformin, Lisinopril",None,Diabetes,,None,"['Chills', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 925070,MI,86.0,M,"Fever up to 101.9 varying throughout the day and lasting into next day (today) @ 100.1 this AM. Tx - Tylenol and fluids, rest, observ.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"trulicity, novolog, Omega 3, jardiance, atorvastatin, Pantoprozol, aspirin, losartan, Vit D 3, Laasix, sucralfate, allopurinol",none,"Diabetes, CRF, CoVid - April -'20, - w esophageal ulcer, this adverse event was a fever - to 101.9 F lasting > 24H",,Ace inhibitors,['Pyrexia'],UNK,MODERNA,IM 925072,OH,34.0,U,"12/23/2020 VACCINATION 12/24/2020 COULD NOT RAISE ARM PAST NIPPLE LINE. COULD NOT TOUCH IT; SWOLLEN, BIG KNOT, HOT TO THE TOUCH. 12/25/2020 STILL COULD NOT RAISE ARM, HOT TO THE TOUCH. CALLED URGENT CARE AND TELEMED CALL. 'SOUNDS LIKE A HEMATOMA UNDER INJECTION SITE THAT IS INFECTED. WILL START YOU ON ANTIBIOTICS'. WITHIN 2 DAYS, PRETTY MUCH PAIN FREE. STILL SORE BUT ABLE TO MOVE ARM. KNOT DISAPPEARED. NO LONGER HOT TO THE TOUCH. STILL SOME RED AROUND INJECTION SITE.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PUB,,,,"INFANT, REACTION TO PERTUSSIN VACCINATION. NO REACTION NOW WITH TDAP",PENICILLAN,"['Injected limb mobility decreased', 'Injection site haematoma', 'Injection site infection', 'Skin warm', 'Swelling']",UNK,MODERNA,SYR 925074,FL,43.0,F,"A week after i received the first injection and after the initial knot had gone away, i noticed that there was a new knot and red welt at the injection site and a smaller knot and welt adjacent to it. Both are still there this morning",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,OTH,"Allegra for seasonal allergies, ibuprofen and Aleve for headaches and other soreness",Nasal congestion,Asthma brought on by seasonal allergies - was not an issue at the time of the Vaccine,,"allergic to penicillin, pollen, dust","['Injection site pain', 'Injection site vesicles']",1,MODERNA,IM 925075,OH,66.0,F,"Headache, nausea, really bad chills that woke her out of her sleep",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,"Lisinpril 40mg, Atorvastatin 40mg, Meloxicam 7.5mg, fish oil 1200mg one twice a day, cranberry pill 250 mg one twice a day, Hydrochlorothiazide 25mg, Sertraline 50mg, Stool softner 250mg one twice a day",none,"High blood pressure, high cholesterol",,none,"['Chills', 'Headache', 'Nausea']",1,PFIZER\BIONTECH,IM 925076,PR,59.0,F,MODERATE LEFT AXILLARY PAIN WORSENS WITH ARM MOVEMENT MODERATE LEFT CERVICAL PAIN AND LEFT SHOULDER PAIN,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,WRK,"VITAMIN C, PANADOL,",,,,IODIDE,"['Arthralgia', 'Axillary pain', 'Neck pain']",2,PFIZER\BIONTECH,IM 925077,GA,46.0,F,"nausea, fever, body chills,headache, tx with Motrin",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Menacycline, Lysine, Magnesium",none,asthma,,none,"['Chills', 'Headache', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925078,NY,39.0,M,"12/29/2020 2 hr after vaccination patient became hypotensive, decreased oxygen levels was transferred to Hospital currently inpatient at hospital - admitted for cardiac arrest",Not Reported,,Not Reported,Yes,10.0,Not Reported,N,12/29/2020,12/30/2020,1.0,SEN,"Reglan 5mg, Maalox Advance 20mg, Prednisone 2.5 mg, Metoprolol succinate ER 25mg, Prednisone Lisinopril 2.5 mg, Eliquis 5mg, Atorvastatin 80mg, Gabapentin300mg, Tylenol 325mg x2, multivitamin, iron 325mg, magnesium oxide 400mg, zinc 220mg,",,"acute cerebral vascular insufficiency, aphasia, cerebral infarction, gastro reflux, vitamin deficiency, long use systemic steroid, central pain syndrome, dermatitis, cardiomyopathy, crones disease, SOB",,,"['Cardiac arrest', 'Hypotension', 'Oxygen saturation decreased']",1,PFIZER\BIONTECH,IM 925079,NY,51.0,M,"I experienced insidous onset of rapid heart rate with palpitations after approximately 2-3 minutes of inoculation. This episode lasted about 1-2 minutes. I was not expecting this having no prior history of adverse response to vaccines. I also felt a flushing sensation in my head. My breathing felt slightly more difficult. No sweating, throat closure or itching. I did not measure pulse and instead tried to breathe/meditate to bring it down. I estimate it was about 140 bpm . Breathing/meditation brought it down but it was still elevated when the nurse checked me after 20 minutes. I remained onsite an additional 15 minutes until I felt well enough to leave but my heart rate was still somewhat elevated, about 20 bpm higher than my usual. My heart rate seemed to fluctuate throughout the evening and my sleep was subsequently very poor. I feel much better this morning, just the usual arm soreness after a vaccination. I have reached out to my primary doctor concerning whether she feels this event would warrant my not getting the second dose or perhaps having a prescribed epipen on my person. Having no personal history but a family history of severe heart disease (father had first MI at age 42, second at 44 followed by triple bypass and CHF) this incident with my heart rate certainly raised some anxiety. I had a routine EKG done in June which was normal, I am a physical therapist and in good health. I am hoping to have the next vaccine in a proper medical facility. I have read CDC recommendations to not have the second shot if certain adverse responses are experienced and I am not certain whether this would qualify. I have no history of adverse reactions to vaccines. Considering the role of anxiety versus the insidious and nearly immediate onset of rapid heart rate with palpitations and persistent elevated heart rate for more than 12 hours, I feel this event was primarily driven by the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,"Lithium 600, Depakote 500, Gabapentin 600, Lamictal 25",None,Bipolar disorder,,"Sensitive to dairy, no history of anaphylaxis","['Dyspnoea', 'Flushing', 'Heart rate increased', 'Injection site discomfort', 'Palpitations']",1,MODERNA,IM 925080,VA,35.0,F,"HEADACHE, EXTREME FATIGUE ON WEDNESDAY AND BOTH WORSED THEN DEVELOPED ON SUNDAY MUSCLE ACHES, DIARRHEA, SORE THROAT WENT TO URGENT CARE ON 12/29/2020 (TUESDAY) TESTED FOR STREP AND COVID",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,MIL,"Spironolactone, labetalol, escitalopram",none,high blood pressure,,none,"['Diarrhoea', 'Fatigue', 'Headache', 'Oropharyngeal pain', 'Pain', 'SARS-CoV-2 test negative', 'Streptococcus test negative']",1,PFIZER\BIONTECH,IM 925081,MI,63.0,F,8 days after injection I've developed inflamed area about 5 inches by 3 inches. Raised area like hives,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"levothyroxine, Maxalt, gabapentin, vitamin C, Zinc",none,"Hypo-Thyroid, IBS, Spondyloarthropathy",,supha,"['Inflammation', 'Urticaria']",1,MODERNA,SYR 925082,NH,38.0,F,"hive like appearance at injection site, next day 1/1 followed by redness and hot to the touch, worse on 1/2 went away by 1/3. returned with redness and hot to the touch on 1/5 worse on 1/6 starting to go away today 1/7",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/31/2020,7.0,WRK,mirena IUD omeprazole,none,asthma intermittent,,milk- mild latex-mild,"['Injection site erythema', 'Injection site urticaria', 'Injection site warmth']",1,MODERNA,IM 925083,GA,38.0,F,"I think there should be a warning against drinking alcohol after the vaccine . Had the same amount as I usually do, 2 mixed drinks, but felt exaggerated affects and dizzy. Speaking to others- 1 glass of wine felt like 2-3.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,UNK,Multivitamin and Prevacid 40 mg once a day,None,None,,Rocephin Sulfa Augmentin,"['Alcohol interaction', 'Dizziness']",1,PFIZER\BIONTECH,SYR 925084,GA,69.0,M,"Injection site pain, headache, muscle pain, chills, joint pain, nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2020,01/06/2021,366.0,PVT,"Metformin 2 500 MG daily, 1 Fenofibrate 145 MG daily, Januvia 100MG daily, Simvastatin 20 MG daily and 1 Adult Multivitamin daily.","Diabetes, Hypertension, Vitamin D Deficiencies, and High Cholesterol.",Diabetes,"site pain, joint pain, muscle aches",None that I am aware of.,"['Arthralgia', 'Chills', 'Headache', 'Injection site pain', 'Myalgia']",1,PFIZER\BIONTECH,IM 925085,MN,38.0,M,Stomach Cramping Vomiting Diarrhea Nausea Body Weakness Chills Sweating profusely without a fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,WRK,Cymbalta Buspirone Inderal Magnesium Vitamin-D Prilosec,None,None,,None,"['Abdominal pain upper', 'Asthenia', 'Chills', 'Diarrhoea', 'Hyperhidrosis', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 925086,IN,42.0,F,"usual adverse reactions included body aches, chills, low grade temp (below 100.0F)runny nose, head congestion. Around 8:30pm, eyes began watering and burning, migraine type pain on left side of head began. At 6am January 7, 2020 left side of face was swollen and sensitivity to light present, pressure and discomfort only on that side of face. Eye swollen and continuously watering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,,,,"Tdap booster age 35/36 approximately 2014, caused tachycardia, chest tightness and difficulty breathing. vaccine details other ",,"['Body temperature increased', 'Chills', 'Eye irritation', 'Eye swelling', 'Facial discomfort', 'Lacrimation increased', 'Migraine', 'Pain', 'Photophobia', 'Rhinorrhoea', 'Swelling face']",1,MODERNA,IM 925087,PA,40.0,F,"Welt on arm noticed on 1/6/21. Next morning on the 7th, noticed it was bigger, red, swollen and warm. Called my workplace's health line and got antibiotics.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"Unithroid, multi-vitamin, prilosec",,,,Penicillin,"['Erythema', 'Peripheral swelling', 'Urticaria']",1,MODERNA,IM 925088,PA,34.0,F,"Swollen throat, hives, and itchy body.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,SEN,,,,,,"['Pharyngeal swelling', 'Pruritus', 'Urticaria']",1,MODERNA,IM 925089,PA,57.0,F,"Site redness, swelling, tenderness, swelling of lymph nodes. Chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PHM,,None,None,,None,"['Chills', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy']",UNK,MODERNA, 925090,TX,60.0,F,"Employee with low grade fever, chills and shaking starting at 2am. Tmax at 5:30 am of 101.2. Self medicated with Motrin with some improvement of symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,,,,,,"['Chills', 'Pyrexia', 'Tremor']",2,PFIZER\BIONTECH,IM 925091,IN,44.0,M,"Started to feel tired the next day at or around 9 AM. At or around 1230, took temp for the first time and it was 100.2 . Took again in two hours, the same. Took IBUPROFEN. At 430, took temp again, 99.6. Then took IBUPROFEN again 4 hours after 430. Went to sleep, slept through the night. Woke up and took temp, it was normal and was not elevated. No current concerns to note.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,Currently taking buspar and Zoloft.,none known,High blood pressure in the recent past.,,none known,"['Body temperature increased', 'Fatigue']",UNK,PFIZER\BIONTECH, 925092,NJ,49.0,M,"Headache, Fatigue, Body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,"Talmasartan 80mg, Amlodipine 5mg",None,Liver Hemangiomas,,None,"['Fatigue', 'Headache', 'Pain']",1,MODERNA,IM 925095,IA,25.0,F,"3:00am - vomiting, headache, dizziness, chills, nausea, fever, extreme fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,WRK,none,none,none,,none,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",UNK,MODERNA, 925096,CA,66.0,M,"Moderate injection site pain, mild loss of appetite, mild headache, mild fatigue and mild nausea. No treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,"Omeprazole, Verapamil, Atorvastatin, Aspirin 81mg, Zovirax, Metformin, Glipizide",None,Type 2 Diabetes,,None,"['Decreased appetite', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea']",UNK,MODERNA,IM 925097,IL,39.0,F,"One week after vaccine, lump at site of vaccine with redness and warmth at the site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,WRK,,,,,,"['Injection site erythema', 'Injection site mass', 'Injection site warmth']",1,MODERNA,IM 925098,,,U,"Dry tongue, fast heart beat, redness and inflammation on vaccination area, inflammation of node in the vaccination arm and joint and muscle pain. Chills, headache and change of taste.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,AH1N1,,"['Arthralgia', 'Chills', 'Heart rate increased', 'Injection site erythema', 'Injection site inflammation', 'Myalgia', 'Taste disorder', 'Tongue dry']",1,MODERNA,IM 925099,PA,50.0,F,"CHILLS, FULL BODY SKELETAL ACHES AND FEVER",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,OTH,none,none,none,,penicillin rash,"['Bone pain', 'Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925100,NC,31.0,F,Moderate fatigue and extreme arm pain 24 hours after shot. Arm pain subsided after 3 days but swelling and redness still present as of 1/7/2021. Very mild itching at injection site as of 1/1/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,"Prozac, Lithium, Adderall",None,None,,None,"['Erythema', 'Fatigue', 'Injection site pruritus', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,SYR 925101,,21.0,F,"Low grade fever, chills, body/joint aches/pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,UNK,,,,,Penicilin,"['Chills', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 925102,PA,55.0,F,Injection inadvertently given subcutaneously (should have been an intramuscular shot),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,crestor. HCTZ,none,diabetes T2,,none,['Incorrect route of product administration'],UNK,PFIZER\BIONTECH,SC 925103,NJ,64.0,F,Palms of hands turned red and blotchy after 10 -15 minutes. Pharmacist gave patient benadryl. Symptoms abated after aprox 30 minutes,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PHM,Estradial 0.0375 patch,none,none,,no,"['Erythema', 'Rash macular']",2,MODERNA,IM 925104,CT,42.0,F,"Pt received vaccine and ten minutes later began complaining of numbness to her face and heart palpitations. At the this time she denied dyspnea, difficulty swallowing, chest pain, nausea/vomiting. She also experienced facial flushing, nausea/vomiting, and diarrhea. She was given 50mg of diphenhydramine intramuscularly. She seemed to make a full recovery.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,"aspirin 81mg tab, buspirone 10mg tab, doxycycline 100mg tab, clotriamazole cream, metoprolol tart 25mg tab",,"anxiety disorder, hypertension, nonrheumatic tricuspid valve disorder",,"hydrocodone, metronidazole","['Diarrhoea', 'Flushing', 'Hypoaesthesia', 'Nausea', 'Palpitations', 'Vomiting']",1,MODERNA,IM 925105,IN,36.0,F,"Got vaccine at 1100am Starting at about 1100pm, I developed shaking chills, myalgia, Frontal Headache, nausea. I had redness and soreness at site of injection. Symptoms resolved within 24hrs with help from Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,None,None,None,,None,"['Chills', 'Headache', 'Injection site erythema', 'Injection site pain', 'Myalgia', 'Nausea', 'Tremor']",UNK,PFIZER\BIONTECH, 925106,NJ,52.0,F,"Cold sore on left corner of mouth, resolved in 1 day with Abreva & Valtrex; mild dizziness for about an hour, injection site tenderness resolved in 1 day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,"Advair, Singulair, Citalopram, Esomeprazole, Claritin generic, Fluticasone",None,"Asthma, Gerd",,None,"['Dizziness', 'Injection site pain', 'Oral herpes']",1,MODERNA,IM 925107,NY,49.0,F,"Arm became increasingly sore at The site throughout the day. Around 1130 last night I got the chills &started to feel achy. I took my temperature there was no fever. Around 330 this morning I woke up feeling much worse with the chills achiness took my temp it was 100.6 took some Motrin. I went back to bed very hard time sleeping because I felt so terrible. Woke up this morning so far no fever but feel achy, still have chills and really fatigued.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,UNK,None,Respiratory infection 12/21/20,None,,None,"['Chills', 'Fatigue', 'Injection site pain', 'Malaise', 'Pain']",1,MODERNA,IM 925108,IN,54.0,F,"Fever of 101 , chills and severe headache for 36 hrs. Sick, weak, no appetite, I felt like I did when I had Covid in June of 2020. Injection site has red raised area that measures 3""x2"". The injection site area seems to grow larger each day. The area is sore and itches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PUB,"vit D3, Multivitamin, levothyroxine, cholersterol med.",no,asthma,,sufla,"['Asthenia', 'Chills', 'Decreased appetite', 'Headache', 'Illness', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Pyrexia']",1,MODERNA,SYR 925109,FL,37.0,F,Pruritic aculopapular rash across abdomen and lower extremities,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,UNK,Prozac,None,None,,None,['Rash pruritic'],2,PFIZER\BIONTECH,IM 925110,MS,40.0,F,Headache and severe stomach pain lasting 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,,,Migraines and bipolar,,Sulfa,"['Abdominal pain upper', 'Headache']",1,PFIZER\BIONTECH, 925111,IN,50.0,F,"Lethargy/fatigue, mild headache (off and on) since approx. 5.5 hrs after vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"bupropion 300XL, magnesium, vitamin D3",,,,,"['Fatigue', 'Headache', 'Lethargy']",1,PFIZER\BIONTECH,SYR 925112,IN,26.0,F,Skin hurting Restlessness Fever Headache Shortness of breath Seeing flashes Malaise Muscle aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Insulin Omeprazole Loraditine,Covid-19,Type 1 diabetes,Flu shot- I was 21. Date was or close to 1/2015. Fatigue and restlessness,Zaditor,"['Dyspnoea', 'Headache', 'Malaise', 'Myalgia', 'Pain of skin', 'Photopsia', 'Pyrexia', 'Restlessness']",1,PFIZER\BIONTECH,SYR 925113,PR,73.0,F,"Strong nausea, vomiting and pallor.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,UNK,,,,,,"['Nausea', 'Pallor', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 925114,ID,45.0,F,"Patient started to have itching on her right side of the neck, then the itching started in the right arm where shot was givien. Patient had redness on the right deltiod. Patient did not have any shortness of breath. Was given 2 tabs of 25mg benadrly @ 5:40 pm. Patient was watched for 30 mins. Patient did have itching that spread to the whole body. Patient said last night she cont to have itching all over the body. She took 2 more benadrly @ 10:00 pm. Patient reports that she is still having itching today 01/07/2021. Took a allergy tab in the am. Patient also reports feeling swollen in the face, neck and hands.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Burpropion 150 mg, Kelnor, Metoprolol ER 25 mg, Methimazole 5 mg",None,"Hypertension, Hyperthyroidism, depression and Anxiety",,coconut and Bee stings,"['Injection site erythema', 'Injection site pruritus', 'Peripheral swelling', 'Pruritus', 'Swelling', 'Swelling face']",1,MODERNA,IM 925115,AR,37.0,F,"Fever, Severe headache and body aches, Tachycardia 120-150, Shortness of breath, Hypertension 160/110",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"Singulair, Flonase, Seasonique, Multivitamin,",none,Asthma,,Environment,"['Blood pressure increased', 'Dyspnoea', 'Headache', 'Pain', 'Pyrexia', 'Tachycardia']",2,PFIZER\BIONTECH,IM 925116,,22.0,M,"Moderna COVID-19 Vaccine: Fever (101.5), tenderness at injection site, headache, nausea, body aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,UNK,,,,,Anaphylaxis to peanuts and tree nuts,"['Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA, 925118,KY,49.0,F,"?Pfizer-BioNTech COVID-19 Vaccine EUA Pfizer Covid 19 vaccine 30mcg/0.3ml Vaccine administered on 12-31-20 at 3:38 pm. Pfizer vaccine Lot EL0142. 0.3ml IM, left deltoid. states felt dizzy after receiving injection. left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 1-1-21; knot grew to ~5x5 cm max size over 48 hrs. Itchy, but painful if tried to scratch. Took Benadryl 1-3-21, took Zyrtec 1-4-21. Evaluated at Employee Health on 1-5-21. Some dizziness with position change. Exam: No fever. No orthostatism to BP. Pulse 77-- >94 from lying to standing. Left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Instructed to take OTC antihistamine (Zyrtec) daily until 7 days after symptoms resolve. PMH significant for Covid 19 infection (positive test Oct. 28, 2020). Hospitalized 11-4-20 for decreased O2 saturation. Treated with Remdesivir. Post-Covid infection shortness of breath/dizziness. A picture of the affected area is available if requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/01/2021,1.0,PVT,,"PMH significant for Covid 19 infection (positive test Oct. 28, 2020). Hospitalized 11-4-20 for decreased O2 saturation. Treated with Remdesivir. Post-Covid infection shortness of breath/dizziness.",,,,"['Dizziness', 'Dyspnoea', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Limb discomfort']",1,PFIZER\BIONTECH,IM 925119,,45.0,M,Developed acute inspiratory wheeze approximately 6 hours after the vaccination was received. Wheeze persisted for 30 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,MIL,"Vitamins A,D,E, and C",none,"tinnitus, PTSD",,Levaquin allergy,['Wheezing'],1,MODERNA,IM 925120,FL,28.0,F,"had a 102 degree fever for about 15 hours which started the evening of 1/5/21, which also included chills and muscle aches. The muscle aches lasted about 24 hours. The injection site was my left arm and I now have swelling in my left axilla which started the evening of 1/6/21 and is still currently swollen. I am an ultrasound technologist and was able to scan myself this morning when I came back to work. It appears I have a cluster of reactive lymph nodes in the area of swelling within my left axilla, the largest measuring 3.0 cm. It is very tender in the area of swelling and the pain radiates down my left arm. I had a lot of pain at the injection site that lasted for about 24 hours, it is now subsiding. However, for the last 24 hours it has been very painful to bend my arm. Any time I tried to bend my arm it sent a throbbing pain down to my left hand, it is still occurring today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Birth control pills,no,no,,none,"['Chills', 'Injection site pain', 'Lymph node pain', 'Lymphadenopathy', 'Myalgia', 'Pain', 'Pain in extremity', 'Pyrexia', 'Swelling']",2,PFIZER\BIONTECH,IM 925121,MD,48.0,F,"On January 4th we were made aware of the following: A few minutes after receiving the vaccine at 8 am on 12-23-2020, the associate suffered from a severe headache 8/10, tingling sensation, BP checked Systolic in 180s, Extremely weak and tired, Severe nausea and dry heaving. Rapid response called, and associate was sent to ER. Headache 7/10. 1 gram Tylenol. Associate states ?Shaking, and I experienced delayed response when questioned by staff. 1 liter saline. Hives treated with Benedryl. In ER from 8am to 11:30am. It was determined that this was not an anaphylactic response. Associate went home with a headache 4/10. Groggy all day from Benedryl. I still have headaches constantly in frontal lobe. The headache pain Can rise from 2 / 10 to 8 /10. The constant headache is in the left frontal lobe. When the headache increases, It radiates into the temporal area as well. Dec 31, I went to Patient First. I was given Toradol IM, but the headache didn?t go away. I was given Flexeril, but it doesn?t help the pain. I am now using Excedrin to take the edge off. Associate is awaiting physician?s return call, but Dr. is out of town. Another doctor in the clinic would not see associate, as they don?t cover other physician?s patients. No fever, no respiratory symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,,"Hypertension well controlled, Diabetes well controlled.","Hypertension well controlled, Diabetes well controlled.",,IV Dye,"['Asthenia', 'Fatigue', 'Headache', 'Hypokinesia', 'Nausea', 'Paraesthesia', 'Retching', 'Somnolence', 'Tremor', 'Urticaria']",1,PFIZER\BIONTECH,IM 925122,,57.0,F,Muscle spasms in neck within 1 hour of receiving vaccine. Severe cramp L calf less than 24 hours after receiving vaccine. Both these symptoms continued until medical evaluation on 07 Jan.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,OTH,JANUVIA,DM II,DM II,,NSAIDS,"['Muscle spasms', 'Muscle tightness', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 925124,OH,51.0,F,"Nausea, diarrhea, vomiting, malaise, joint pain, muscle pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,WRK,Effexor Atorvastatin Omeprazole Famatodine,None,GERD HIGH CHOLESTEROL GENERAL ANXIETY DISORDER,,Seasonal allergies,"['Arthralgia', 'Diarrhoea', 'Malaise', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 925125,IN,40.0,F,"Developed chills, fever (102), headache, body aches, back pain, sore arm at injection site. I had covid March 2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,WRK,None,None,None,,None,"['Chills', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 925126,PR,43.0,F,"Intense pain at vaccination site, can't use my arm for anything, fever 38.9C that only goes down with ibuprofen. Chills, pain all over the body, can't put my feet on the floor because of plantar pain on my feet. Rib pain and axillary pain on my left side, lack of appetite, throat pain, stomach pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,WRK,"losartan, toprol,metformin,amlodipine,vit d 3,",no,"diabetes, hypertension, anemia, vitamin D deficiency",,Penicillin,"['Abdominal pain upper', 'Axillary pain', 'Chills', 'Decreased appetite', 'Injection site pain', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'Vaccination site movement impairment']",2,PFIZER\BIONTECH, 925127,FL,47.0,F,"Fatigue, fogginess, difficulty concentrating, sleepiness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,Effexor ER 150mg EVE multi vitamin Vit D3 5000UI B100,none,Depression,,none,"['Fatigue', 'Feeling abnormal', 'Mental impairment', 'Somnolence']",UNK,MODERNA,IM 925128,NJ,64.0,F,Tightening in the throat.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,"Atorvastatin, Metoprolol, Ticagrelor, Aspirin.",,"Coronary artery disease (since May) Bilateral hip dysplasia 1 pack-a-day smoker, 50 yrs.",,No known allergies.,['Throat tightness'],1,PFIZER\BIONTECH,IM 925129,NJ,44.0,F,"Since I got the vaccine, my left eye bothers me in way that I have a watery, itching , red eye & feeling of sand on it. It bothers me more at night, it started at the same night of vaccination (1/4/21). Today is 1/7/21 and still bothering me.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,Levothyroxine 88mcg 1 tab po daily dexilant 60 mg 1 tab po daily Align 1 tab po daily Vit C 1000 mg 1 envelope daily Losartan 50 mg 1 tab po daily,,High Blood pressure Mitral & Atrial valve Leakage,,Natural pistachio Latex,"['Eye irritation', 'Eye pruritus', 'Lacrimation increased', 'Ocular hyperaemia']",1,MODERNA,IM 925130,NY,47.0,F,"Tongue tingling, confusion, anxiety, increased blood pressure, dry throat, increased heart rate,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,"Epinephrine, Benadryl, Ibuprofen",Hypertension,Hypertension,Flu,"Latex, flu vaccine, mangoes, peaches, kiwis, pistachios, apricots, wheat","['Anxiety', 'Blood pressure increased', 'Confusional state', 'Dry throat', 'Heart rate increased', 'Paraesthesia oral']",1,MODERNA,SYR 925131,IN,33.0,M,"Loss of appetite, Chills, fever, chest pain. Took a gram of Tylenol per day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Vit D,None,None,Chills with flu shots,NKA,"['Chest pain', 'Chills', 'Decreased appetite', 'Pyrexia']",1,MODERNA,IM 925132,PA,24.0,F,Swollen lymph node near collarbone,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,WRK,,,,,,['Lymphadenopathy'],1,PFIZER\BIONTECH,IM 925133,IN,49.0,M,"Fatigue, approximately 11am day of (may have been exacerbated by less sleep the night before), (lasted 36 hours). Chills (lasted an hour or so), spiked fever (lasted maybe 8 hours mostly while sleeping), muscle soreness/tightness (shoulders/neck, Lasted 12-15 hours,) Headache ( lasted about 12-15 hours, and I never get headaches).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/06/2021,,PVT,"Jardiance, Losartan, amodipine, Zyrtec, metfromin, simvastatin",None,"Diabetes, hypertension","COVID-19 1st dose. Chills, fever, fatigue",None,"['Chills', 'Fatigue', 'Headache', 'Muscle tightness', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 925134,TX,56.0,F,"Day 1 post vaccine arm hurt and a 2"" x 2.5"" raised red area around vaccine site. Felt this way for a few days. Redness and pain started fading after 4-5 days. Day 8, I still have a little pain but the site is itching and there is now a deeper red area with some discoloration. I am on Day 9 post vaccine now.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PUB,"Metroprolol 50 mg, levothyroxine 88 mcg, Prilosec OTC, prescribed allergy drops (in place of allergy shots), allegra",migraines,migraines,Allergy injections at age 19,quinalones,"['Injection site discolouration', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,IM 925135,MS,48.0,F,"Fever, headache, chills, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,Effexor XR 75mg Lisinopril 20mg Claritin 10mg Aciphex 20mg,None,None,,Demerol and Sulfa,"['Chills', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,SYR 925136,PR,31.0,F,"Fever, chills, body ache, nausea, dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,Complete Vitamins,none,none,,none,"['Chills', 'Dizziness', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA, 925137,IL,46.0,F,"Having pins and needles in left hand, today having it in right hand as well, no treatment at this time still having symptoms this morning at time of report",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,None,None,None,,None,['Paraesthesia'],2,PFIZER\BIONTECH,IM 925138,IN,46.0,F,"T= 101.5, Severe joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"Duloxitine 120mg, ASA 81mg, Vit C, Vit D, Multivitamin, Elderberry, Fish Oil, Cinnamon with Chromium, Calcium with D",None,Depression,,Nobe,"['Arthralgia', 'Pyrexia']",UNK,MODERNA,IM 925139,WI,43.0,F,Developed shingles symptoms 5 days following the vaccine in the T1 dermatome distribution on same arm in which vaccine was administered,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/04/2021,4.0,OTH,,,,,,['Herpes zoster'],1,MODERNA,IM 925140,NH,42.0,F,"After a week the arm is still tender with a red mark at the injection site that is itchy, red and hurts to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"Ortho Tricyclen, Wellbutrin, Lexapro, and Hydroxyzine",None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Pain in extremity']",1,MODERNA,IM 925141,PA,49.0,M,"Temporary loss of taste followed by decreased hearing in the left ear. There were in addition to joint pains, pain the rt arm, body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/05/2021,2.0,PVT,None,None,"Migraines, seasonal allergies",,"NSAIDS , but okay with selective COX-2 inhibitors","['Ageusia', 'Arthralgia', 'Hypoacusis', 'Pain']",2,PFIZER\BIONTECH,IM 925142,IN,32.0,M,The vaccine was given at hospital on 12-24-2020 at about 10:30am and five minutes after my heart rate dropped significantly and they had to wheel me in to the emergency room. They checked my oxygen levels and monitored my heart rate.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,,,,,,"['Electrocardiogram', 'Heart rate decreased']",1,PFIZER\BIONTECH,IM 925143,FL,48.0,M,Developed Herpes Zoster on Left Forehead,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,Bystolic,,HTN,,None,"['Herpes virus test', 'Herpes zoster']",2,PFIZER\BIONTECH,IM 925144,IN,42.0,M,"Low grade fever, chills, muscle aches and mild headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,UNK,None,None,None,,None,"['Chills', 'Headache', 'Myalgia', 'Pyrexia']",UNK,MODERNA,IM 925146,WY,41.0,F,Rash on trunk. Started with 2 lesions and they have spread.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PUB,,,,,"Sulfa, Penicillin, latex",['Rash'],1,MODERNA,IM 925147,PA,43.0,F,Severe headache that brought tears due to pain. Chills. Nausea. Burp up bile. Exhausted. Subsided after 7 hours. Intermittent headaches that only last for a few minutes and then subside.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/31/2020,30.0,PUB,None,None,Obese,,Skin allergy to nickel,"['Chills', 'Eructation', 'Fatigue', 'Headache', 'Nausea', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 925148,TN,62.0,M,felt like I had covid starting 12 hrs after vaccine for about 20 hours. I had previously had covid,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PUB,none,non,none,,none,['Influenza like illness'],1,MODERNA,IM 925149,TN,54.0,M,"Approx: 12 hours after vaccination, started with severe headache extreme cold chills with fever of 101.8, extreme body aches along with Nausea. Treatment of Tylenol as directed by medication suggested dose and time. NOTE: I had a positive COVID test on December 9th",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,UNK,"Metformin, Glimepiride, Metoprolol, Lipitor",Tested positive for Covid-19 on December 9th with symptoms starting the night before,Diabetic,,NKA,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,SYR 925150,PR,52.0,F,"Swollen left cheek area, compatible with effects reported with dermal fillers on patients in clinical trials. I had dermal fillers placed on cheeks in early 2019. Today swelling is almost gone. Took antihistamines Claritin, Monday, Tuesday and Wednesday. Spoke with a collegue regarding the reaction. I am wondering about my second dose and same kind of reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/04/2021,2.0,PUB,no,no,no,,no,['Swelling face'],1,MODERNA,IM 925151,OK,57.0,F,"Chills, body aches, fever, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Estrace, Levothyroxine, Zoloft, Bystolic, Zyrtec, Ambien, Singulair",None,Hypothyroidism,,"Morphine, Sulfa, Chloraprep","['Chills', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925152,OK,46.0,F,"Left arm sore upon administering. Around 5pm soreness increasing, ice used. 10pm at bedtime continued ice, unable to move arm, pain radiating from shoulder to fingers. Midnight awoken due to pain, unable to move arm, nauseous, chills, feeling like I could pass out. Only able to sleep minimal due to pain. 4am still unable to use arm. 8am nauseated, zofran taken, crackers and Tylenol. 9am, still nauseous, arm soreness not worsening",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,"Armour thyroid, progesterone, phentermine, Pepcid, Allegra, multivitamin, fish oil, vit d, zinc, testosterone cream",None,None,,NKDA,"['Chills', 'Dizziness', 'Insomnia', 'Nausea', 'Pain', 'Pain in extremity', 'Vaccination site movement impairment']",1,MODERNA,IM 925153,TX,35.0,F,C/o fever of 101 next day. Treatment include Tylenol. Symptoms resolved. Patients feels much better has been return back to work.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,,,,,,['Pyrexia'],2,PFIZER\BIONTECH,IM 925154,FL,84.0,F,Deceased,Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,PUB,Avorstatin Aspirin Oxycodone,NONE,COPD,,None,['Death'],UNK,MODERNA, 925156,NJ,67.0,F,"Received Moderna vaccine on Dec. 29 with just some muscle ache at injection site for about 3 days, then soreness disappeared. during night of Jan. 6th, I noticed soreness again at site and in morning of January 7 I have some redness, and slight swelling with minor soreness at injection site. The time frame is odd, since I received injection more than a week ago.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,PHM,"Vitamin D and a Zinc,Calcium andVitaminC supplement (for Hair, skin and nails)",no,no,"Flu Vaccine in Setptemer 2020 arm sore at injection site immediately after vaccine for a day and then gone, no redness",no,"['Injection site discomfort', 'Injection site erythema']",1,MODERNA,IM 925157,TX,27.0,F,"Extreme swelling, redness, and itching at place vaccine was injected one week after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,UNK,Birth control,None,Asthma,,Penicillin,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA, 925158,TX,43.0,M,"a full body rash. Last night temp was 103.7 without drugs and 102.1 with drugs. Headache, dizzy, Nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,none,"COVID-19, Strep, Pneumonia, Flu all 12/19/2020 onset for all.",,,none,"['Dizziness', 'Headache', 'Nausea', 'Pyrexia', 'Rash']",1,MODERNA,IM 925159,VA,28.0,F,"Moderna COVID-19 Vaccine EUA. Around 7pm on 06Jan21, symptoms began with a headache, increased heart rate, inability to sleep/relax. On 07Jan21, Migraine headache, inability to sleep/relax, increased heart rate, passed out, lightheaded, back pain, neck pain, weak, fever, chills, hot, dehydrated (even with large consumption of water). Took two motrin and an hour nap, which severely decreased above symptoms but still experienced them.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,MIL,"Viorelle, multi vitamin, vitamin c, zinc/magnesium/d3 vitamin",,,,,"['Asthenia', 'Back pain', 'Chills', 'Dehydration', 'Dizziness', 'Feeling hot', 'Headache', 'Heart rate increased', 'Insomnia', 'Loss of consciousness', 'Migraine', 'Neck pain', 'Pyrexia']",1,MODERNA,IM 925160,WI,26.0,F,"Stomach ache, headache, joint and muscle soreness, fatigue, extreme soreness and pain at injection site, and malaise.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,None,None,Asthma,,None,"['Abdominal pain upper', 'Arthralgia', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Myalgia']",1,MODERNA,IM 925161,MA,59.0,F,"Severe headache came on suddenly. Neck, shoulder and body aches Extreme fatigue NO elevated temperature",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,WRK,Amlodipine 10 mg Daily Atenolol 50 mg Daily Spironolactone 100 mg Daily Albuteroll MDI prn,none,asthma HTN,,Lisinopril,"['Fatigue', 'Headache', 'Pain']",1,PFIZER\BIONTECH,IM 925162,NC,,F,"Patient was riding in a car and began feeling dizzy and passed out, this happened ten times and over the evening and decided to go to the ER the next morning at 7am. These episodes lasted 5 minutes or so and then she was able to regain consciousness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/05/2021,5.0,PUB,None,None,Hx of Cytomegalovirus,,Allergic to Bee Stings,"['Chest X-ray', 'Computerised tomogram head', 'Dizziness', 'Drug screen', 'Electrocardiogram', 'Full blood count', 'Laboratory test', 'Loss of consciousness', 'Magnetic resonance imaging']",1,MODERNA,IM 925163,IL,56.0,F,"""Hot, Blotchy"" given Benadryl 25mg liquid, po x1 dose. Resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,PVT,,none reported,unknown,,None reported,"['Feeling hot', 'Rash macular']",1,PFIZER\BIONTECH,IM 925165,IN,20.0,F,"An hour after I became super itchy -8:00am 12:30- chills began 1:30 body aches 6- low grade fever, fatigue Next day- sore throat, headache, body aches, chills, fever of 104.6 I was shaking so bad from being cold Then I had night sweats",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,None,,,,Allergic- to morphine,"['Chills', 'Fatigue', 'Feeling cold', 'Headache', 'Night sweats', 'Oropharyngeal pain', 'Pain', 'Pruritus', 'Pyrexia', 'Tremor']",1,MODERNA,SYR 925166,CO,25.0,F,"headache, diarrhea, fatigue, chills, sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/03/2021,3.0,PVT,,,,,,"['Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Oropharyngeal pain', 'SARS-CoV-2 test negative']",1,MODERNA,IM 925167,WI,39.0,F,"Sever left arm pain, neck pain, bilateral shoulder pain, right arm pain, headache, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Lisinopril/hctz 10-12.5-1 daily, famotidine 20-1 daily, cetirizine hydrochloride 10mg-1tablet daily, iron 65 mg-1 tablet daily, one a day women?s formula multivitamin-1 daily, amitriptyline 10-5 tablets daily",None,"HTN, migraines, Gerd, Irritable bowel, obesity",,Tequin,"['Arthralgia', 'Headache', 'Nausea', 'Neck pain', 'Pain in extremity']",1,MODERNA,IM 925168,TX,51.0,F,chills and severe body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/18/2020,2.0,PVT,"Losartan, montelukast, propranolol, ASA 81 mg",none,,,none known,"['Chills', 'Pain', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 925169,WI,29.0,F,Migraine started about 24 hours after getting the 2nd shot on 1/4 at 9:20,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,wellbutrin,None,I usually get migraines,,amoxicillin,['Migraine'],2,PFIZER\BIONTECH,IM 925171,FL,51.0,F,Pfizer-BioNTech COVID-19 Vaccine EUA swelling in throat approximately 30 minutes after injection. Took oral Benadryl 50mg and symptoms began to subside about 15-20 minutes later with full resolution in about 1 hour.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,Prilosec Multi-vitamin,None,Asthma H/O SVT H/O ITP,,Aspirin Ibuprofen Shellfish Bee Stings,['Pharyngeal swelling'],1,PFIZER\BIONTECH,IM 925172,MS,45.0,F,"Headache approximately 6 hours after vaccine.. identified it identical to the headache i had when I had covid 10/5/20. Woke up at 1am and head to toe body aches, hips, feet, back, knees... Tylenol 500mg took at 838 am 1/7/20",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Treshiba 200/ml 25 U daily, Magnesium 400mg 2 bid, forfiveo XL 450mg qd, colchicine 0.6mg qd, Inspra 25mg 2 qd, torsemide 50mg qd, kcl 10meq 2 bid, lexapro 20mg qd, brilanta 90mg bid, asa 81 qd, metoprolol 25mg 2 am 1 pm, vitamin c 100mg bi",none,"Rheumatoid Arthritis, STEMI 12/2019, DM, CAD, Chronic systolic heart failure, thyroid nodules, HTN, Hyperhydrosis, OSA, Hyperlipidemia, low magnesium, hyokalemia",,Avelox,"['Headache', 'Pain']",1,MODERNA,IM 925173,IN,45.0,F,Burning sensation. Started in left side of neck went to left shoulder then spread out all over body. Headache and fever,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,"Tylenol, vitamin C, multivitamin",None,Migraines,,"Thimersol, sulfa, acyclovir, zithromax, doxycycline","['Burning sensation', 'Headache', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 925174,PA,16.0,F,No reported adverse reaction...Just that patient was given Moderna and is < 18 yrs of age.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Proair Flovent,,Asthma,,NKDA,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA, 925175,IN,63.0,F,My trunk area starting itching. I developed a fine rash on chest/ abdominal area. A few hive like weals appeared on abdominal area. No other symptoms. I took Benadryl 50 mg . After a while itching subsided. No further issues.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,Losartan potassium 25mg/day Lexapro 5mg /day,None,None,,None,"['Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 925176,CO,55.0,F,left arm swelling around injection site onset one day after injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/01/2021,1.0,PVT,"ibuprofen, omeprazole","October, November, December: cough",osteoarthritis,,nkda,['Injection site swelling'],1,MODERNA,IM 925178,ME,56.0,F,"red rash to injection site that is warm, hard and spreading over the left upper extremity",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site rash', 'Injection site warmth']",1,MODERNA,SYR 925179,NY,58.0,M,"Fever, chills, headache, body on day after vaccination. The persistent ventricular ectopy and anxiety days 2-4 after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/17/2020,1.0,PVT,"Losartan,Lipitor, Aspirin",None,"Hypertension, Hyperlipidemia, Prostate Cancer, Asthma",,None,"['Anxiety', 'Chills', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 925180,TX,45.0,F,"IMMEDIATE 10 MINUTES IN TO 2 HOURS LATER I FELT DIZZY, NAUSEA, LIGHT HEADED, PRESSURE IN EYES, BURNING SENSATION FROM EARS TO THROAT, BLOOD PRESSURE WENT HIGH TO SYSTOLIC PRESSURE OF 180'S, EXTREME PAIN AT INJECTION SIGHT, WAS GIVEN ZOFRAN AND BENADRYL AT 1HR MARK. LATER IN EVENING I HAD FEVER, EXTREME PAIN AT INJECTION SITE AND TO THE NECK AND BACK AND DOWN TO FOREARM, NEXT DAY I HAVE EXTREME PAIN IN ALL PREVIOUSLY MENTIONED AREAS AND FATIGUE AND OVERALL BODY ACHES AND SINUS PRESSURE",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"ROSVUSTATIN, DAYQUIL, NYQUIL, INSULIN, MOTRIN","COLD/CONGESTION , GASTROENTERITIS",DIABETES,"FLU VACCINE IN 2012, 2013, 2014","FLU VACCINE 2012, 2013, 2014; FLUOROQUINOLONES","['Burning sensation', 'Dizziness', 'Eye oedema', 'Fatigue', 'Hypertension', 'Injection site pain', 'Nausea', 'Pain in extremity', 'Paranasal sinus discomfort', 'Pyrexia', 'Throat irritation']",1,MODERNA,IM 925181,IL,61.0,M,"""Pain like a torn rotator cuff, i couldn't lift my arm. After about 2 weeks i was back to 80% mobility. on 1/7/21 i am almost back to 100%. No other symptoms""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/20/2020,2.0,PVT,,none reported,,,none reported,"['Pain in extremity', 'Vaccination site movement impairment']",1,PFIZER\BIONTECH,IM 925182,IN,51.0,F,"Fever, severe chills, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,WRK,"Carvedilol, potassium, Lipitor, valsartan, levonorgestrel",None,"Hypertension, hyperlipidemia",,"Pcn, e-mycin, tequin, minocycline,","['Chills', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 925183,IN,27.0,F,"Myalgias, chills, fatigue, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Adderall,None,"Eczema, ADHD",,None,"['Chills', 'Fatigue', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH,IM 925184,CA,45.0,F,Headache Nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Headache', 'Nausea']",1,MODERNA,SYR 925185,VA,26.0,F,"patient received vaccine 0818, in observation area 08:30 reported that she felt cold, sweaty palms and decreased sensation in hands, ate yogurt 2 hours prior to vaccine 08:32 bp: 124/85, o2sat 99%, hr 94, drinking pepsi, ate peanut butter crackers and granola bar 08:40 patient reports palms less sweaty, bp 141/63, hr 90, 1 glucose tablets administered 08:50 glucometer 130, bp 130/65, hr 83 9:10 T 98.0 oral, bp 125/78, hr 83, patient reports hands no longer cold, palms not sweaty, sensation normal in hands 9:22 patient left to go home, states she felt normal",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,unknown,none,none,,watermelon,"['Feeling cold', 'Hyperhidrosis', 'Sensory loss']",2,PFIZER\BIONTECH,IM 925187,IA,60.0,F,"Extreme fatigue, muscle aches ,joint pain. Have slight headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,"Synthroid, Allegra, Sudaphed, Vitamin C, Vitamin D, Fish Oil, Hair and Nail Supplement, Calcium Chewable.",None,"Hypothyroid, Diabetes, Arthritis. History of two strokes and Aneurysm.",,"Anaphylactic reaction to Aspirin, Ibuprofen.","['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 925188,AL,27.0,M,"fatigue, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,none,none,none,,none,"['Chills', 'Fatigue']",2,PFIZER\BIONTECH,IM 925189,NY,58.0,F,"Injection site is red, hard and itchy - 5 days after injection- still the same today 7 days after",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PVT,tylenol,none,childhood asthma,"Shingles vaccine 2019 2 dose, 58 years, chills fever, headache, sore arm","Allergic to mold, dust, cat and dog dander","['Injection site erythema', 'Injection site induration', 'Injection site pruritus']",1,MODERNA,IM 925191,AR,58.0,F,"I received the vaccine at 8:30 am, felt fine before and afterward, until about 4:30pm. I started having chills, then joint pain and headache, my skin hurt to touch it, an overall feeling of blah. about 6:30pm I started running a low grade temp of 100. I took 2 extra strength Tylenol and went to bed. At 10pm my temp was 101, I took 600mg of Ibuprofen. I woke up at 12.35am and could tell that my fever was down, but my body still ached and I still had a headache. I went back to sleep, woke up about 6:30am and my fever was 100.2 with chills, skin pain, joint pain, and headache. I have taken 2 more Tylenol extra strength.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,Flecainide 50mg BID Propranolol 10mg BID Mobic 15 mg daily Claritin 10mg daily,none,Heart arrhythmia Arthritis,,Sulfa drugs Psyllium,"['Arthralgia', 'Chills', 'Headache', 'Pain of skin', 'Pyrexia']",1,MODERNA,IM 925192,,35.0,F,"Sore lymph nodes in injection arm started 6 days after injection, injection site reaction started almost a full week after injection. Swelling, itching, redness, warmth, soreness. Symptoms are still present 48 hours after they began",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,UNK,"Bupropion, citalopram, Zyrtec, nortel, keratin",None,None,,Sulfa and ceclor drugs,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Lymph node pain']",1,MODERNA,IM 925193,IN,26.0,M,"Extreme fatigue, chills, loss of appetite. I just tried to sleep the whole day after the vaccine and it seems to have gotten a little better two days after the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PUB,,,,,,"['Chills', 'Decreased appetite', 'Fatigue']",UNK,MODERNA,IM 925194,GA,43.0,F,"Patient states that approximately 8 days after receiving vaccine (Moderna COVID- 19 Vaccine EUA), she experienced redness and swelling at and around the injection site. States area was 6 cm tall by 10 cm wide. States contacted her private provider who referred her back to the Health Department. States went to Urgent Care where she received steroids and antibiotics. States the area has improved however does remain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PUB,Amlodipine as needed,None,None,,NKA,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 925195,NC,52.0,M,"Immediate ""medicine-y"" taste in mouth, lasted about 15 minutes. Given benadryl 50mg orally. Vitals checked, seen by PA and extended monitoring time",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Lisinopril, HCTX, zyrtec",hx of hypertension,,,nkda,"['Dysgeusia', 'Immediate post-injection reaction']",1,MODERNA,IM 925196,NJ,44.0,F,9 days after the injection itchiness started on my left upper arm. After several scratches to alleviate the itchiness I checked the site & noticed that where the vaccine was administered was red & warm to the touch. It progressively started getting more itchy. Then the muscle soreness started. It felt as if I just had the injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,PVT,Levothyroxine 112 mcg; Excedrin,,Hashimoto's Thyroiditis,,"Hazelnuts, Chestnuts, Walnuts, Percocet, bee stings,","['Injection site erythema', 'Injection site pruritus', 'Injection site warmth', 'Myalgia', 'Skin warm']",1,MODERNA,IM 925197,ID,67.0,M,"red rash appeared around injection site 10 days after vaccination or 1/1/21. In addition fatigue, body aches and headache were experienced in the two days following. Rash progressed from upper deltoid to elbow. Only slightly pruritic. Symptoms treated with acetaminophen (headache/body aches) and cetirizine (rash). body and headache resolved 1/4/21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/01/2021,9.0,PVT,multivitamin,none,none,,NKA,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site rash', 'Pain', 'Rash pruritic', 'SARS-CoV-2 test']",1,MODERNA,IM 925198,NC,22.0,F,.8 ml vaccine administered by vaccinating nurse. Further Education provided regarding recommended dose. Clinician states that the just in time training that was provided information that .8 ml was the recommended dose. Client made aware of the error; medical provider onsite assess client immediately post and again after 45 min observation time prior to discharge from clinic site. no signs or symptoms of adverse reaction observed by RN or reported by client. Client aware that state immunization branch has been notified and that adverse event reports will be filed at both Pfizer website and on federal VAERS website.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,unknown,unknown,unknown,,none,"['Incorrect dose administered', 'No adverse event']",1,PFIZER\BIONTECH,IM 925199,AZ,61.0,M,"soreness at injection site, fatigue, mild nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,MIL,"Metformin, Pioglitazone, Ezetimbe, Losartan, Glyburide, Aspirin",NONE,Diabetes II,,Demerol,"['Fatigue', 'Injection site pain', 'Nausea']",UNK,MODERNA,IM 925200,MA,43.0,F,"following day after vaccine I woke with with moderate headache hip , joint and muscle pain. 1/4 the pain went away. on 1/6 the pain has came back and it is more severe. I called employee health and I am waiting on call back from them.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,WRK,No,no,back pain,flu shot - 2009,no,"['Arthralgia', 'Headache', 'Myalgia']",UNK,MODERNA,SYR 925201,,36.0,F,"Reports developed half dollar sized whelp, red, hot and bruised 5 inches below injection site on 1/6/21. Rash on chest started, took Benedryl 25mg PO, woke up 1/7/21 took another Benedryl 25 mg PO and started with itching on torso and back. Reported had some nausea evening of 1/6/21 took Pepto Bismal. Instructed to seek further medical evaluation with rash/itching continuing to spread.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/06/2021,8.0,UNK,,,,,"Percocet, Bactrim, Dicloxacillin","['Injection site bruising', 'Injection site erythema', 'Injection site warmth', 'Nausea', 'Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 925203,OK,56.0,F,Arm hurts and woke up with headache fever and body aches 12 hrs after vaccine was administered.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,no,no,no,,sulpha,"['Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925204,IN,34.0,F,"Chills, fatigue, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,None,None,None,,None,"['Chills', 'Fatigue', 'Headache']",UNK,PFIZER\BIONTECH, 925205,NE,36.0,F,"On the night of 01/04, she developed a sore throat, headache, and bilateral ear pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/04/2021,5.0,PUB,"Desvenlafazine, phentermine, birth control",,,,,"['Ear pain', 'Headache', 'Oropharyngeal pain']",1,MODERNA,IM 925206,TX,34.0,M,"FEVER OF 101 STATUS POST DAY ONE AS WELL AS CHILLS, MALAISE AND WEAKNESS,HEADACHE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,none,none,none,,levaquin po,"['Asthenia', 'Chills', 'Headache', 'Malaise', 'Pyrexia']",2,MODERNA,IM 925208,VA,58.0,F,Arm redness and pain at injection site. Achy.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Unknown,Diabetes and High Blood Pressure,See above,,None - seasonal only,"['Injection site erythema', 'Injection site pain', 'Pain']",1,MODERNA,IM 925209,TX,47.0,F,headache for 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,synthroid @ 0.25 mcg birth control pill,none,allergies to pollen,,latex,['Headache'],1,MODERNA,IM 925210,IN,46.0,M,"Significant muscle pain and muscle fatigue. Initially only at injection site, but spread to entire left arm within 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Metformin, simvastatin",,Diabetes (type II),,None,"['Injection site pain', 'Injection site reaction', 'Muscle fatigue', 'Myalgia']",1,MODERNA,IM 925211,,27.0,M,"Fatigue, muscle pain, chills, fever, headache, injection site swelling and pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,UNK,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 925212,SD,25.0,F,"Appears to be a localized reaction, then became surrounded by an area of cellulitis. Area is red, warm to touch, itchy and tender to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,SCH,"adapalene topical cream, azelastine nasal spray, dapsone topical gel, fluticasone propionate nasal spray, Vitamin D",,,,NKDA,"['Cellulitis', 'Erythema', 'Local reaction', 'Pruritus', 'Skin warm', 'Tenderness']",1,MODERNA,IM 925213,KS,58.0,M,Pain in whole right arm (injection side) Fatigue Muscle Ache all over,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,MIL,None,None,Diabetes and heart Disease,,Bactrim,"['Fatigue', 'Pain', 'Pain in extremity']",UNK,MODERNA, 925214,LA,62.0,F,"Chills, no fever. %hours after heart palpitations followed by nausea and vomiting. Temp up to 102.4. Lasted 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,WRK,"Fishoil, Vitamin C, MVI, Caltrate",None,None,,"PCN, Valium","['Chills', 'Nausea', 'Palpitations', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 925215,FL,42.0,F,hypnopompic hallucination,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,WRK,none,none,none,,none,['Hypnopompic hallucination'],1,PFIZER\BIONTECH, 925216,NE,49.0,F,"DEVELOPED HIVES ON BACK, THAT THEN WENT DOWN THE RIGHT ARM. ARM GOT VERY HOT TO THE TOUCH AND INJECTION SITE GOT HARD. LAST A FEW HOURS AND THEN HIVES WENT AWAY. NO MEDICINE WAS TAKEN TO HELP RESOLVE.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,,,,,,"['Injection site induration', 'Skin warm', 'Urticaria']",1,PFIZER\BIONTECH,IM 925217,AL,38.0,F,"Vomiting, nausea, fever, severe back pain, other myalgias, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,None,None,None,,Beef and Pork,"['Back pain', 'Full blood count', 'Headache', 'Influenza A virus test', 'Influenza B virus test', 'Myalgia', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test', 'Streptococcus test', 'Urine analysis', 'Vomiting']",1,MODERNA,IM 925218,VA,28.0,F,"06Jan21-Unable to sleep, increased heart rate, headache. 07Jan21- Increased heart rate, headache, back pain, neck pain, passed out, weak, fever, chills, hot, dehydrated (even after consuming lots of water all day). Took motrin and one hour nap, decreased symptoms severity but did not get rid of them.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,MIL,"viorelle, multi vitamin, vitamin c, zinc/d3 vitamin",,,,,"['Asthenia', 'Back pain', 'Chills', 'Dehydration', 'Feeling hot', 'Headache', 'Heart rate increased', 'Insomnia', 'Loss of consciousness', 'Neck pain', 'Pyrexia']",1,MODERNA,IM 925219,OR,66.0,F,"Woke up Thursday am with hives on right lower abdomen and leg getting progressively worse throughout the day. By that afternoon had back pain in right back and continuing hives. Woke up Friday with numbness to right leg, hives, and back pain all on right side of body. Had numbness to foot, face but especially thigh, back and across upper buttocks. Saturday hives subsiding, numbness receding to face, upper thigh and foot only on right side of body. Sunday, back pain some improved, no hives or hives minimal, numbness persists upper thigh face and foot on right side of body. Monday, Tuesday and Wednesday the same. Woke up Thursday with shingles rash to upper thigh back, numbness to foot face and upper thigh persist only on right side of body. Darn!!!",Not Reported,,Not Reported,Not Reported,,Yes,N,12/30/2020,12/31/2020,1.0,PVT,"Lysine, levothyroxine, B complex, Emergency C Estraidiol patch",none,hypothyroid,"Flu, , does not regularly get Flue vaccine as have had several episoede of flu illness last flu vaccine three years ago a half ",Septra,"['Back pain', 'Herpes zoster', 'Hypoaesthesia', 'Rash', 'Urticaria']",1,MODERNA,IM 925220,,39.0,F,fever of 101.0,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,['Pyrexia'],UNK,PFIZER\BIONTECH, 925221,PR,44.0,M,"General malaise, body ache, fever 38.1 C, mild cough, nasal congestion.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Metformin 1000 BID, Advair 250/50, Atacand 32, Cardizem",Bronchitis,"brochial asthma, hypertension, DM type 2",,"Penicilline, eggs and seafood","['Cough', 'Malaise', 'Nasal congestion', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925222,VA,23.0,F,"On 1/5/21 I developed chills, body aches, and a sore arm. As of 1/6/21 the chills and body aches have stopped.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/05/2021,4.0,PVT,Tylenol,,,,Codeine,"['Chills', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 925223,IA,45.0,F,"Within 15-20 minutes of the vaccine I was Vomiting, diarrhea and had very severe stomach pains lasting a few hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Verapamil,Covid and just had recovered 12/14/2020,None,,Vicodin and Kelflex,"['Abdominal pain upper', 'Diarrhoea', 'Vomiting']",1,MODERNA,IM 925224,NY,25.0,F,"Right after shot administered to my left arm, left numbness and tingling feeling on left arm and hand. After a few hours numbness on arm disappeared but the ring and pinky finger are thingy and numb. Hand feels cold, don't have feeling on 2 fingers in left hand as of 1/7/21 at 10:21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,,,Asthma,Flu vaccine,,"['Hypoaesthesia', 'Paraesthesia', 'Peripheral coldness']",UNK,PFIZER\BIONTECH,SYR 925226,,35.0,F,"35 y.o female present to the ER after receiving the first dose to her COVID 19 vaccine. Initially experiencing a metallic taste in her mouth, palpitations, and nausea. She felt lightheaded but did not lose consciousness. Her symptoms rapidly improved. Her vital signs remained normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,,,,,PVT,None,,Healthy/No known comorbidities,,,"['Dizziness', 'Dysgeusia', 'Nausea', 'Palpitations']",UNK,PFIZER\BIONTECH,IM 925227,,43.0,F,"Pt received vaccine on 12/18 and developed erythematous, pruritic hives on 12/21. Was rx'd hydroxyzine without significant benefit (has brief relief is sx but recur before next hydroxyzine dos is due). Pt was seen twice in the ED for these sx. Pt was told sx were related to muscle strain. Pleuritic chest pain and cough. Ongoing cutaneous and respiratory adverse reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,,,,,PVT,Prednisone; hydroxyzine; REMICADE INFUSION,,Immune-compromising condition,,,"['Adverse reaction', 'Cough', 'Erythema', 'Muscle strain', 'Pleuritic pain', 'Pruritus', 'Urticaria']",UNK,PFIZER\BIONTECH,IM 925236,,57.0,F,"57 yo F, healthcare worker, with history of asthma and penicillin allergy who presented to emergency department for reaction to COVID-19 vaccine. Patient received first dose of COVID-19 vaccine (Pfizer) and immediately became flushed, erythema to trunk and face, and intensely pruritic. No signs of airway involvement or wheezing. Vitals were stable. Patient was treated with benadryl which improved symptoms. Anaphylactoid reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,,,,,OTH,ADDERALL; gabapentin; ondansetron; Montelukast; albuterol HFA; amlodipine; lubiprostone; fluoxetine; alprazolam,,Asthma/COPD; Diabetes mellitus (DM); Hypertension (HTN),,,"['Adverse reaction', 'Anaphylactoid reaction', 'Erythema', 'Flushing', 'Immediate post-injection reaction', 'Pruritus']",UNK,PFIZER\BIONTECH,IM 925241,,37.0,M,"37 y.o. male presents for evaluation of headache, dizziness. Pt is employee here and had his COVID 19 vaccination, 1st dose, earlier today. States that he had felt fine for about 20-30 minutes s/p injection. Began to develop mild headache, gradually worse, now about 4/10. Not thunderclap. No associated focal weakness/numbness. No visual change/loss. No n/v. No hx of same. + associated vertigo worse w/ movement, resolved when at rest, mostly when he looks to right. No other complaints at this time. Required urgent care visit along with meclizine 25mg given orally symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,,,,,UNK,,,"Right sided abdominal pain; right hand paresthesia, ulnar nerve entrapment at left ulnar groove; biliary dyskinesia",,,"['Dizziness', 'Headache']",1,PFIZER\BIONTECH,IM 925242,TN,50.0,F,"Did well till one week later and arm developed fever, swelling and allergic red reaction around injection site and whole arm sore and hard, tender to touch severe itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PUB,"Hydroxychloroquine 400mgs,Armour Thyroid two doses (1 tablet 120mgs & 15mgs) Lisinopril 5mgs, Sertraline 100mgs, Vitamin D3 5,000, Vitamin B-12, Vitamin C, Melatonin 5mgs, Spironolactone 100mgs.,Multi-Vitiamin Womens 50+, Glucosamine, Aspri",Autoimmune Diseases/Thyroid,Same as above since 2014,,Bactrim,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 925243,WI,60.0,F,"Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. without any issues. Came home, had 2 glasses of wine, as usual, at 1:00 a.m. feeling body aches and headache continued sleeping, woke up at 9:00 a.m. with dry heaves with phlegm with small streaks of blood, rapid heart rate, fatigue with body aches, pain in location of injection, occasional headache, loss of appetite. The body aches, fatigue continued the following day, appetite returned slightly. Thankful these were my scheduled days off from work. Third day after injection body aches dissipating able to go out of the house to do errands.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"None I had the vaccine at 10:30 a.m. on Monday 1-4-21, and went to work from 1:45 pm. through 10:00 pm without issues. When I returned home, had 2 glasses of wine, as my usual, and started to feel a headache and body aches around 1:00 am",None,Seasonal allergies,,None,"['Decreased appetite', 'Fatigue', 'Headache', 'Heart rate increased', 'Injection site pain', 'Pain', 'Retching', 'Sputum discoloured']",2,PFIZER\BIONTECH,IM 925244,OH,25.0,F,"Cervical lymphadenopathy of only one lymph node (left-side), discovered 5 days post-vaccine. Localized rash discovered 8 days after vaccine. Stopped taking Zyrtec 4 days post-vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PUB,"Nadolol, daily multivitamin, Zyrtec",None,Migraines,Localized rash after influenza vaccine 10/2020,Adhesive bandages,['Lymphadenopathy'],1,MODERNA,IM 925245,TN,21.0,F,Deep red rash on face and chest with severe itching,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Zyrtec 10mg Tablets daily,none,none,,"tests have shown nothing specific, but allergies occur randomly","['Pruritus', 'Rash', 'Rash erythematous']",1,PFIZER\BIONTECH,IM 925246,,27.0,F,"chills, nausea, body aches, headache, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 925248,NJ,34.0,F,"Joint pain, body aches, feeling feverish with no fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/06/2021,5.0,UNK,"Tizanidine, tramadol, ciproflaxin",,,,None,"['Arthralgia', 'Pain', 'Pyrexia']",1,MODERNA,SYR 925250,PA,38.0,F,My face became flush and broke out rash on back and shoulder.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/25/2020,2.0,WRK,Sertraline 50Mg a day and Omeprazole 20Mg a day.,None,None,,"Seasonal allergies: Penicillin, ceclor, sipro,","['Flushing', 'Rash']",1,PFIZER\BIONTECH,IM 925251,MD,29.0,F,"Severe pain at injection site (right arm) and entire right arm since 8 pm 1/6/21. And hard nodule/swelling at the injection site noted this am at 5 am, 1/7/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Hydrochlorothiazide, Pepcid",none,Migraines,,Penicillin,"['Injection site induration', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 925252,CO,42.0,M,"Fever, body aches, chills, dizzyness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Bupropion, citalopram",,Depression,,penicillin,"['Chills', 'Dizziness', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925253,KS,48.0,F,"Tired, trouble getting to sleep and staying asleep. Arm pain, body aches, tired and sluggish. Mild nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,UNK,Tizanidine 4mg,None,Fibromyalgia,,None,"['Fatigue', 'Insomnia', 'Nausea', 'Pain', 'Pain in extremity', 'Sluggishness']",1,MODERNA,SYR 925254,TX,40.0,F,"I woke the next morning with flu like symptoms my arm was hurting, I was feelin tired and really couldn't get out of bed. As the day progressed I got chills, started running a fever, It went up to 104 and my heart rate went up and down from 120-165 so I went to the ER. They gave me fluids and ran a whole bunch of test, tested me for Covid and Sepsis and everything came back normal and negative for Covid. They monitored my heart rate and once it started getting back to normal, they ended up letting me go home, I was there from 8pm to about 3am. After that I felt tired and felt like when I had Covid back in November. I started feeling better about Sunday, still a little tired but felt more back to normal. My heart rate is still getting back to normal so my Dr is following me on that.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/22/2020,12/23/2020,1.0,WRK,,,,,Levaquin,"['Chills', 'Fatigue', 'Full blood count normal', 'Heart rate irregular', 'Influenza like illness', 'Mobility decreased', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative', 'Septic screen']",1,PFIZER\BIONTECH,SYR 925255,KS,58.0,F,"Received vaccine 12-28 with no reactions observed until 1-6, when awoke with red feverish area approx 4 1/2 x 2 1/2 inches rt upper arm where vaccine was given. Observed in Health Department 1-7, area of redness has decreased to approx. 2 1/2 X 2 1/2 inches.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/06/2021,9.0,PUB,"Bp, cholesterol and thyroid meds",None,"Diabetes, hi cholesterol, high bp, low thyroid",,None,"['Injection site erythema', 'Injection site warmth']",UNK,MODERNA,IM 925256,OK,30.0,F,"12/26/2020 WOKE UP, STOMACH HURTING, DIARRHEA. MALAISE. CYCLE BETWEEN BOTH, ALL DAY. WENT TO ER SAME DAY; EVENING. COULD NOT GET A STOOL SAMPLE. VITALS WERE GOOD. ADMINISTERED IV FLUIDS. 12/27 STOMACH STILL HURTING BUT NOT AS SEVERE.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/26/2020,,PUB,BIRTH CONTROL,,,,,"['Abdominal pain upper', 'Diarrhoea', 'Malaise']",1,PFIZER\BIONTECH,SYR 925257,,30.0,F,"fever, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 925258,NH,57.0,F,"The next morning, 12/24 and I woke up my head was very heavy and I was dizzy and I had a hard time getting out of the bed, my leg felt like jello, like sea legs, like I was on a boat. That continued all day and I also had chills and did not feel good later in the day. I did not work 12/24 and 12/25 I felt a little better but my legs specially my thighs felt really heavy. Saturday the dizziness continued and then that is when I went to the UC (12/26) to get a covid test (rapid and sent out one both negative). The dizziness improved, I still have a funny heavy feeling on my upper tights. I had a little numbness on my hands on the 12/24 and 12/25but it seems to have resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,"Losartan, hydrochlorothiazide, potassium. protonix, estradiol, multivitamin, stool softener, Tylenol/ ibuprofen as needed",No,No,the very first time about 10 years ago I got the flu vaccine I felt like I was hit by a tractor but I still take the flu shot ev,penicillin,"['Chills', 'Dizziness', 'Head discomfort', 'Hypoaesthesia', 'Limb discomfort', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 925259,CO,82.0,F,"Nausea, vomiting, diarrhea, headache beginning about 11 hours after vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,,,,,Penicillin inj - hives,"['Diarrhoea', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 925260,RI,50.0,F,Day after vaccine: Upper back and neck stiffness and ache; injection site swollen/ache; eyes stinging; extreme lethargy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,Wellbutrin Allergy med,Some sinus pressure,,"2018 flu vaccine 48 yrs old fever, chills, lethargy ; body aches",Sulfa,"['Back pain', 'Eye pain', 'Injection site pain', 'Injection site swelling', 'Lethargy', 'Musculoskeletal discomfort', 'Musculoskeletal stiffness']",2,PFIZER\BIONTECH,SYR 925261,TN,58.0,F,"Within an hour of receiving the injection I lost 100% of my hearing in my right ear. Starting with some ringing, vertigo and then just silence. I called the Pfizer hotline, and they took down some information and then directed me to call the COVID hotline which resulted in pretty much the same. As it was Christmas day and the weekend, I waited to contact my Primary Physician on 12/30/20. She saw me immediately and sent me to a Specialist the next day to see Dr. for my hearing loss. There I was given an audiological assessment where my right ear was found to have moderately severe to profound sensorineural hearing loss in the right ear.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/25/2020,12/25/2020,0.0,PVT,Premarin .625 SUMAtriptan 50 mg (as needed for migraines) Diclofenac 1% gel for arthritis pain,,,Penicillans shot at 15 years old and broke out in a Rash,Penicillans,"['Audiogram abnormal', 'Deafness neurosensory', 'Deafness unilateral', 'Tinnitus', 'Vertigo']",1,PFIZER\BIONTECH,SYR 925262,NE,28.0,F,"Rash started on 1/6 around the injection site. Developed into L axillary lymphadenopathy, fatigue, myalgias, and headache. Erythema does recede with benadryl but does not resolve. was a little wheezy on 1/6. She has h/o anaphylaxis due to latex and has an epi pen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,ADDERALL XR 20 MG QAM,,"F98.8, D68.0, E56.9, F32.9, R23.8",,LATEX,"['Fatigue', 'Headache', 'Injection site rash', 'Lymphadenopathy', 'Myalgia', 'Wheezing']",1,MODERNA,IM 925263,WV,63.0,M,Rash resembling shingles to left mid back/side,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,OTH,,No,,,NKA,['Rash'],1,MODERNA,IM 925264,OK,77.0,M,PT was found deceased in his home on 1/5/2021,Yes,01/07/2021,Not Reported,Not Reported,,Not Reported,N,12/31/2020,,,OTH,"Norco 5/325 1 tablet every 6 hours as needed. Warfarin 4mg , 2 tablets orally Monday and Friday Torsemide 100mg, 1/2 tablet orally once a day Sabcubitril-Valsartan 24/26mg 1/4 tablet orally twice a day Gabapentin 300mg, tablet once daily Ca",CHF HTN DM 2 CKD Obesity DDD,CHF HTN DM 2 CKD Obesity DDD,,NKDA,['Death'],1,MODERNA,IM 925265,ME,29.0,F,"Welted, Red, Raised, Swollen, Hot, Change in size/color. Gets better, then gets worse. Large area of effect.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"Entivyo, Zoloft, Verapamil, Vitamin D, Calcium, Potassium",,Crohns Disease,,Erythromycin & Doxycycline,"['Injection site erythema', 'Injection site rash', 'Injection site warmth', 'Urticaria']",UNK,MODERNA,IM 925266,OK,30.0,F,"12/26/2020 DIARRHEA, MALAISE, SEVERE STOMACH PAINS. WENT TO ER. ADMINISTERED IV FLUIDS. 12/27/2020 STARTED TO FEEL BETTER.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/26/2020,,PUB,BIRTH CONTROL,,,,,"['Abdominal pain upper', 'Diarrhoea', 'Malaise']",UNK,PFIZER\BIONTECH,SYR 925267,,35.0,F,"EMPLOYEE NOTICED AN INCREASE IN HER HEART RATE APPROXIMATELY 5 MINUTES AFTER RECEIVING THE MODERNA COVID VACCINE. SHE NOTIFIED MONITORING NURSE WHO BEGAN COLLECTING VITAL SIGNS AND ESCALATED TO LEAD. LEAD, OBSERVED EMPLOYEES PULSE OF 125. EMPLOYEE REMAINED SEATED IN MONITORING ROOM FOR 35 MINUTES. PROVIDED HER WITH WATER TO DRINK. PULSE REASSESSED 35 MINUTES AFTER ADMINISTRATION AND REST AND PULSE WAS STILL ELVATED AT 118. EMPLOYEE INSTRUCTED TO CONTACT PCP OR URGENT CARE WITH ANY CONCERNS OR IF OTHER SYMPTOMS DEVELOP. EMPLOYEE DROVE SELF HOME AS SHE HAD NO OTHER CONCERNS.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,['Heart rate increased'],UNK,MODERNA, 925268,NC,29.0,F,Stomach cramps started a few hours after the vaccination. My menstrual cycle started about 24 hours after the vaccination. I was not due to start until the following week after the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,SEN,,,"Type 1 diabetes, hashimoto hypothyroid",,,['Abdominal pain upper'],1,MODERNA,IM 925269,WI,40.0,F,"Elevated heart rate and BP, headache, dry mouth, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,SEN,,,,,,"['Blood pressure increased', 'Dizziness', 'Dry mouth', 'Heart rate increased']",UNK,MODERNA,IM 925270,TX,38.0,F,"Shot given in left arm. Muscle fatigue in left arm, left side of neck and left chest.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PHM,"Klonopin, Lexapro",,Obesity,,,['Muscle fatigue'],UNK,MODERNA, 925271,OH,49.0,F,"About 2 hours after the shot, the injection area started to hurt. By the end of the first day, my left shoulder muscles were painful (pain grade: 2~3 out of 10). This pain subsided in about 3 days. Starting from 1/2/2021, a red, warm, and itchy papule is visible around the injection site, measuring up to 4 cm. Meanwhile, a mildly painful (2-3/10) lymph node could be palpated in my left axilla. The pain exacerbates upon pressure (4/10). The swelling and mild pain persist until today. Only occasional tylenol and topical anti-itch cortisol cream were used.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,Vitamin C supplement 1000 mg daily,None,None,"Flu vaccine on 9/26/2020; injection site muscle pain for 2 days, 49 yo at time of vaccination",Penicillin,"['Arthralgia', 'Injection site erythema', 'Injection site pain', 'Injection site papule', 'Injection site pruritus', 'Injection site warmth', 'Lymphadenitis']",1,MODERNA,IM 925272,IN,48.0,F,Throbbing pain in arm. Later I started to have heart palpitations and aching all over my body. Around 7am the next day I ran a low grade fever and felt flushed also both hands felt like I had severe arthritis. I ending up sleeping most of the day on January 6th. Today January 7th I feel much better but still have pain in my left arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,None,None,None,,Sulfa,"['Flushing', 'Pain', 'Pain in extremity', 'Palpitations', 'Pyrexia']",1,MODERNA,IM 925273,PA,38.0,F,I became flush in my face and broke out with a rash on my arms and back. I just took Benadryl at home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,WRK,None,None,None,,None,"['Flushing', 'Rash']",1,PFIZER\BIONTECH,IM 925274,NY,36.0,M,"Pain at the injection site upon injection that increased over time, eventually with swelling and redness. Starting the following day I developed a headache and had an increased temperature, eventually a fever reaching 100.7 F. Temperature has returned to normal the following day. Pain at the injection site persists.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,covid-19,,,Penuicillin,"['Headache', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Pyrexia']",1,MODERNA,IM 925275,,62.0,F,"chills, fever, joint pain, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Arthralgia', 'Chills', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 925276,WV,20.0,F,"Chills, Headache, Muscle or Body Aches",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,SEN,Birth Control Patch,None,None,,Nasonex,"['Chills', 'Headache', 'Myalgia']",UNK,PFIZER\BIONTECH,IM 925277,AL,47.0,F,"Shaking chills, myalgia and bone pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,Aimovig Motrin,None,Migraines,,Latex,"['Bone pain', 'Chills', 'Myalgia', 'Tremor']",2,PFIZER\BIONTECH,IM 925279,IL,28.0,F,"""About 10 to 15 minutes after the vaccine, I started itching on my eyelids and neck. The nurse gave me Benadryl and it went away. My eye lids got scabby, but it could have been from scratching them""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Eyelid margin crusting', 'Eyelids pruritus']",1,MODERNA,IM 925280,FL,43.0,F,"I initially developed left arm soreness in the evening of administration of the injection. The following day I developed chills and myalgias. On 1218 2021, I developed shooting pain down my right leg. Later that evening I developed persistent tingling and numbness in my hands, both, as well as tingling and numbness in both my feet. Since that time I have had persistent tingling and numbness. These symptoms have persisted since this time. They are worse with cold weather. Not associated with any weakness however I do have some increased fatigue ability in my right forearm, which may be unrelated.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/18/2020,2.0,PVT,NEXIUM Calcium supplements,GERD,GERD,,No,"['Chills', 'Fatigue', 'Hypoaesthesia', 'Limb discomfort', 'Myalgia', 'Pain in extremity', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 925281,IA,55.0,F,severe chills and fatigue that last until 12/26/2020,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"Advair, Progesterone, Triametrine, Amlodipine; Trazadone, Metformin, Aldactone, Iron,, Vitamin C",None,"Asthma, COVID (hospitalized 5/19/20 - 5/23/20)",,Lasix and penicillin,"['Chills', 'Fatigue']",1,MODERNA,IM 925282,PA,16.0,F,No adverse reaction noted. Pt was just noted to be < 18 after vaccine administration.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,Proair Flovent,,Asthma,,NKDA,['Product administered to patient of inappropriate age'],1,MODERNA, 925283,KY,40.0,F,"Redness, swelling and intense itching at injection site 7 days after vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,PUB,Propranolol 20mg,,,,Allergy to Sulfa drugs,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA,SYR 925284,,25.0,F,Red and blotchy skin along with dizziness and tachycardia that resolved in 30 minutes. Patient was monitored and given something to drink.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,"['Dizziness', 'Rash macular', 'Tachycardia']",1,MODERNA,IM 925285,WI,47.0,F,Severe headache & neck ache even after taking Tylenol - reduced to mild at time of survey Mild all over body aches - on going at time of survey Pain when bending joints - resolved at time of survey Moderate radiating pain from shoulder to elbow of the injection arm - on going at time of survey,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,St. John's Wort Tylenol 500 mg Vit B complex CoQ10 Zinc Picolinate Zicam,None,None,,None,"['Arthralgia', 'Headache', 'Injection site pain', 'Musculoskeletal discomfort', 'Pain']",1,MODERNA,IM 925286,IL,38.0,F,"I was feeling fine prior to receiving the vaccine on 1/2/21. After getting the vaccine, 9hrs later I developed a fever of 102 that lasted for 9 hrs, body aches, chills, and vomiting. The fever lasted on and off until 1/4/21, body aches and nausea continued until 1/5/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,Prozac 30 mg once a day,none,none,,none,"['Chills', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting']",1,MODERNA,IM 925287,NY,36.0,F,"Arm soreness (start within 10 minutes) Chills, body ache, mild fever: started within 14 hours, continuing 24+ hours (present)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,"metformin, 2000mg Wellbutrin, 450mg Aldactone, 100mg",None,Polycystic Ovarian Syndrome,,"Eggplants, Walnuts: tongue pain/itchiness. No history of severe allergic reaction or anaphylaxis","['Chills', 'Limb discomfort', 'Pain', 'Pyrexia']",1,MODERNA,IM 925288,KS,37.0,F,"injection site is red, swollen, and warm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,Prenatal Vitamin Vitamin D,,,,none,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 925289,TN,30.0,F,"Patient developed localized injection site induration, itching, and pain initially after vaccine that subsided after 2 days. On day 8, local injection site reaction returned again more severe with well demarcated redness, tenderness, and itching. No systemic allergy symptoms such as wheezing, urticaria, or facial/airway swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,Ibuprofen and Benadryl,None,None,,Not to my knowledge,"['Injection site induration', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,IM 925290,,30.0,F,"fever, vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Pyrexia', 'Vomiting']",UNK,PFIZER\BIONTECH, 925291,FL,47.0,F,Pt c/o of warm sensation going up left arm into neck.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,,HTN,,"Ace ihibitors, Diovan, Lisinopril",['Limb discomfort'],1,MODERNA,IM 925292,NJ,32.0,F,"shortness of breath, chest pains, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,none,none,ulcerative colitis,flu vaccine in 2018,none,"['Chest pain', 'Dizziness', 'Dyspnoea']",1,MODERNA,SYR 925293,AZ,30.0,M,Malaise and joint aches for 1.5 days. Right upper axillary (proximal armpit area) lymph node swelling and tenderness for around 3-4 days then gradually less pain with dissipation of swelling over 2-3 days (after initial 3-4 days) before back to normal.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,None,None,None,,Seasonal and Feline,"['Arthralgia', 'Lymphadenitis', 'Malaise']",1,PFIZER\BIONTECH,IM 925294,WV,27.0,F,"Headache, Temperature, Body Aches, Chills, Sweaty",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,SEN,"Zyrtec, Multi Vitamin",Sinus Infection 1 week ago,No,,"PCN, Bactrim","['Chills', 'Headache', 'Hyperhidrosis', 'Pain']",UNK,PFIZER\BIONTECH,IM 925295,IA,55.0,F,severe chills and fatigue that last until 12/26/2020,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,None,Asthma and Covid hospitalization 5/19/20 - 5/23/20,,Lasix and penicillin,"['Chills', 'Fatigue']",1,MODERNA,IM 925296,VT,54.0,F,"Local reaction at vaccine site 10 days after shot, red, warm, hard, itchy. Had hospitalist look at and they recommended Benadryl. Symptoms resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/03/2021,10.0,PVT,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",UNK,MODERNA, 925297,CA,55.0,F,Migraine sore arm nausea body aches stiff elbows,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Joint stiffness', 'Limb discomfort', 'Migraine', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,SYR 925298,NC,87.0,M,"Starting about 16-18 hours after shot - fever 102+, nausea (couldn't eat) , headache, body sore all over (like flu), weak as a kitten. Symptoms lasted for about 36-48hours. Took 2 extra strength tylenol three time during period of reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,SEN,"Aspirin 81mg; Atorvastatin 10mg; Diltiazen 240mg; Furosemide 10mg; Fenofibrate 80mg; Rabeprazole 20mg; tramadol 50mg; Trianterene Hctz 37.5mg; Vitamin D3 1,000; Multivitamin; PreserVision AREDS2",None,Bovine aorta heart valve; pacemaker; chronic lower back pain,,None,"['Asthenia', 'Headache', 'Influenza like illness', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 925299,NJ,52.0,M,"1/5/21 -10:45 AM - Received vaccine. 1/5/21 - 10:30 PM - 1/6/21 - 3:00 PM - Generalized 7-8/10 pain in muscles and joints, weakness and 100- 101F temp. 1/6/21 - ~1:00 - 5:00 AM - 4 or 5 SEVERE full body muscle spasm from my neck/jaw to toes preceded by cold chills. I was unable to move or break away as my muscles were being painfully squeezed-lasted roughly 10-15 seconds or more. It was painful and terrifying. I was also incredibly thirsty. 1/6/21 - 3:00 PM - Sore muscles and 3 areas on my spine feeling tender, moderate numbness and tingling down my right leg and foot.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,"venlafaxine, cetirizine, vitamin D3",None,None,,None,"['Arthralgia', 'Asthenia', 'Chills', 'Hypoaesthesia', 'Muscle spasms', 'Myalgia', 'Paraesthesia', 'Pyrexia', 'Tenderness', 'Thirst']",1,MODERNA,IM 925300,OK,40.0,F,"AROUND 10PM THE DAY OF VACCINATION DEVELOPED HEADACHE, LOW GRADE FEVER, CHILLS, FATIGUE, MUSCLE ACHES AND JOINT PAIN. SHE MISSED WORK THE NEXT DAY, DID NOT SEE PHYSICIAN, DID NOT TAKE ANY MEDICATION. SYMPTOMS LASTED 18 HOURS, AND SHE WAS COMPLETELY BETTER WITHIN 48 HOURS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,UNKNOWN,NONE,NONE,,NONE,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 925301,IA,44.0,F,"dizziness, chills, sweating, headache, nausea, restlessness, tachycardia",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,none,COVID 19 diagnosed on 12/7,none,,erthromycin,"['Chills', 'Dizziness', 'Headache', 'Hyperhidrosis', 'Nausea', 'Restlessness', 'Tachycardia']",UNK,MODERNA,IM 925302,,43.0,F,"anaphylactic reaction 2 hours post vaccine, given 2 rounds of epi in the ED in addition to allergic reaction meds, still with rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Anaphylactic reaction', 'Rash']",UNK,PFIZER\BIONTECH, 925303,MD,58.0,F,"Sore arm , sore throat, myalgia, chills fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,Losartin amlodapine vitamin d,None,Hpt,,Penicillin,"['Chills', 'Fatigue', 'Limb discomfort', 'Myalgia', 'Oropharyngeal pain']",2,PFIZER\BIONTECH,IM 925304,PA,31.0,F,"Moderna Vaccine: fever (101.6 Deg. F) starting early next morning, soreness of arm (a few hours after injection), Headache (minimal)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,SCH,"Sertraline, allegra, omeprazole",None,"Eosinophil esophagitis, allergies, anxiety",,"peanuts, tree nuts, dogs, cats, trees, weeds","['Headache', 'Limb discomfort']",1,MODERNA,IM 925305,,49.0,F,"Labored breathing, tightness in the back of the throat, headache, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Dizziness', 'Dyspnoea', 'Headache', 'Throat tightness']",UNK,MODERNA,IM 925306,NE,50.0,M,Pain/Swelling in R side lymph nodes (underarm area),Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,WRK,"Generic zyrtec, zinc, echinacea complex, flaxseed oil, dhea",None,seasonal/pollen and dust allergies,,NKA,"['Axillary pain', 'Lymphadenitis']",1,MODERNA,IM 925307,MD,39.0,F,"Drunken feeling/light headedness(2 days-unsafe to drive), light chest pain(1 day), right earache(1 day), slight headache(1 day-took tylenol), severe left arm muscle pain(2 days) then light left arm muscle pain(2 more days)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Armour thyroid, aimovig, amitriptyline, multi-vitamin, vitamin B12",Seasonal allergies,"Hashimoto thyroiditis, adhd, asthma, fibromyalgia, osteoarthritis,",,"Nickel, gold, blue dye, eggs, tree nuts","['Chest pain', 'Dizziness', 'Ear pain', 'Headache', 'Pain in extremity']",1,MODERNA,IM 925309,FL,59.0,M,Severe itching in arms 30 minutes after injection. No SOB or facial swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,MIL,"Lisinopril, hydrochlorathiazide, atorvastatin, gabapentin, exenatide microspheres",None,"Diabetic, hypercholesterolemia",,PCN - anaphylaxis,['Pruritus'],2,PFIZER\BIONTECH,IM 925310,,39.0,F,"fever, vomiting and rash",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Pyrexia', 'Rash', 'Vomiting']",UNK,PFIZER\BIONTECH, 925311,IN,51.0,U,Red raised warm area at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/05/2021,8.0,UNK,"Amlodipine, estradiol",,Hypertension,,Sulfa,"['Injection site erythema', 'Injection site rash', 'Injection site warmth']",1,MODERNA,IM 925312,IL,27.0,F,"Fatigue, Headache, Body aches for 1 day, helped with 1 gm of tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,Bisolvi,,,,PDS Suture,"['Fatigue', 'Headache', 'Pain']",UNK,PFIZER\BIONTECH, 925313,WV,27.0,M,"Within ~5-7 minutes of receiving the first dose of the pfizer vaccine in my right shoulder, I started to feel lightheaded/dizzy and disoriented. Heart rate increased a bit. Slightly labored breathing. Started feeling overall strange throughout body, general malaise. Didn't advance beyond this. Took 50mg of benadryl shortly after and symptoms improved over the following hour.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,None,None,None,,None,"['Disorientation', 'Dizziness', 'Dyspnoea', 'Feeling abnormal', 'Heart rate increased', 'Malaise']",1,PFIZER\BIONTECH,IM 925314,NJ,,F,UNBEARABLE PAIN FROM MY NECK TO RIGHT ABOVE MY ELBOW ON MY LEFT ARM.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,MOTRIN,NONE,HIGH BLOOD PRESSURE,,NONE,"['Neck pain', 'Pain in extremity']",1,MODERNA,SYR 925315,,36.0,F,"Hives, itching, wheezing, tachycardia, high b/p, difficulty breathing",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Omeprazole, Zyrtec, unisom, vit D",None,"Ehlers-Danlos syndrome, central sleep apnea, migraines, r/o mast cell activation syndrome",,Taxol,"['Dyspnoea', 'Hypertension', 'Pruritus', 'Tachycardia', 'Urticaria', 'Wheezing']",1,PFIZER\BIONTECH,IM 925316,CT,59.0,F,"Vaccination 1/5 @ 10:30 am - mild left arm discomfort @ injection site, otherwise no symptoms On 1/6 eve, approximately 10 pm, noted worsening to severe pain in left anterior shoulder/ subclavicular area into axilla with prominent & well delineated area of swelling & tenderness, most prominent in & just below axilla, associated with numbness & tingling down the ulnar side of arm to 2 fingers (ring & little finger).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Levothyroxine sodium 100 mcg tablet daily Skelaxin 800 mg tablet, twice daily Cyclobenzaprine HCL 10 mg tablet, twice daily Nabumetone 500 mg tablet, twice daily Zolpidem Tartrate 5 mg table daily @ hs Adult multivitamin 1 daily",none,Hoshimoto's thyroiditis Fibromyalgia Arthritis Bursitis Lumbar back pain with radiculopathy History of Lyme disease,,Penicillin Reglan Compazine Phenothiazines ETOH (ingested alcohol) - no issues w/ topical skin prep alcohol,"['Arthralgia', 'Axillary pain', 'Hypoaesthesia', 'Limb discomfort', 'Lymphadenitis', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 925317,,22.0,F,vomiting and fever,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Pyrexia', 'Vomiting']",UNK,PFIZER\BIONTECH, 925318,OH,45.0,F,"Localized cutaneous reaction of increasing size, 10 x 20 cm, erythematous macule.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,WRK,none,none,none,,none,"['Rash erythematous', 'Skin reaction']",1,MODERNA,IM 925319,KY,39.0,F,"I am not sure if this was a result of the vaccine or not and am trying to be helpful! I woke up 1/4/2020, feeling nauseous. I vomited about 6 times that day and had diarrhea. Next morning, my face was flushed. I had a low grade fever of 99.5, and checked my BP. On my home machine, my pulse was 135. I decided to go to the hospital. My Apple Watch measured my heart rate to be 150 at one time. At the ER, I was diagnosed with sinus tachycardia and dehydration. I was placed on oxygen as my levels were between 90-93, and I was given IV fluids. I have felt fatigued since then, some nausea, and mild diarrhea still.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/04/2021,2.0,PVT,"Meloxicam, sertraline, methyldopa",Back pain,"Depression, anxiety, high blood pressure, sleep apnea",,None,"['Diarrhoea', 'Fatigue', 'Flushing', 'Nausea', 'Pyrexia', 'Sinus tachycardia', 'Vomiting']",1,PFIZER\BIONTECH, 925320,NY,39.0,F,"(1/5/21 at 3:45pm) About 20 minutes after the vaccination I felt weak and with a headache, for the rest of the day. (1/6/21) It was my day off, I was still weak and headache I took Tylenol for the pain. (1/7/21) About 3:00 am I had a lot of headache I got up and took 2 Tylenols,the pain continued but more bearable I went to work at 6am always with a headache and feeling weak. From work they sent me home so that I could take the Covid Test, and also do this report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,None,None,None,,None,"['Asthenia', 'Headache']",1,PFIZER\BIONTECH,SYR 925321,MI,51.0,F,"had, headache, body aches, chills ,GI upset, heartburn, sweats the next day. then 2 days later had loose stools, day 3 swollen lymph nodes in my next. day 4 rash on my back that was red, itched, burned . went away about 12 hours after they came.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/03/2021,1.0,UNK,,,,,,"['Abdominal discomfort', 'Chills', 'Diarrhoea', 'Dyspepsia', 'Headache', 'Hyperhidrosis', 'Lymphadenopathy', 'Pain', 'Pruritus', 'Rash erythematous']",UNK,PFIZER\BIONTECH, 925322,ME,32.0,F,"Almost immediately after the injection patient's arm began to feel cold and then numbness started from her upper arm down into her hand. The nurse who administered the vaccine inspected the injection site and did not see any issues. The patient stayed in the area for 50 minutes for monitoring. Her vital signs were taken and were within normal limits, she ambulated in the room and moved her right upper extremity freely including coordination exercises. Numbness/coldness was still present at 13:42, but slowly improved. As of 01/07/2021, patient's arm numbness has resolved but has had intermittent tingling in legs and feet. Continuing to monitor.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Hypoaesthesia', 'Peripheral coldness']",1,MODERNA,IM 925323,AL,37.0,F,103 fever severe body aches chills and fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,None,None,None,MMR two years old hives,Sulfa Doxycycline Morphine Milk Tylox Rocephin,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925324,FL,31.0,F,"Fever of 102 Chills uncontrollably shaking muscle aches severe headache pain and redness at injection site- warm and hard All symptoms lasted around 24 hours of first onset. The injection site is still painful , red and hard.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,Possible Covid,,,,"['Chills', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site warmth', 'Myalgia', 'Pyrexia', 'Tremor']",UNK,MODERNA,SYR 925325,,63.0,F,flashing lights in left eye that have turned to floating spots,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/04/2021,5.0,UNK,estradiol patch,none,none,,none,"['Photopsia', 'Vitreous floaters']",7+,MODERNA,IM 925326,TX,72.0,M,Fever;pain in toe,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,Atorvastin; lisinopril;metoprolol;amlodipine,Mild URI,ASCVD;HTN;hyperlipidemia,,NKA,"['Pain in extremity', 'Pyrexia']",1,MODERNA,IM 925327,,39.0,M,"fever, vomiting, rash and ears burning",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Ear discomfort', 'Pyrexia', 'Rash', 'Vomiting']",UNK,PFIZER\BIONTECH, 925328,PR,56.0,F,"Pain on injection site, turned red, swollen & hard.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,no,high blood presure,no,,no,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 925329,IN,21.0,M,"Full body muscle aches, pain at injection site, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,None,None,None,"Flu vaccine - muscle aches, pain at site. Unable to provide dates, unable to provide brand",None,"['Headache', 'Injection site pain', 'Pain']",1,PFIZER\BIONTECH,SYR 925330,WA,33.0,F,Severe Achyness Fever 100.2 Headache Stomach ache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,None,None,None,"Headache, Tiredness",Penicillin,"['Abdominal pain upper', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 925331,VT,56.0,M,Very tired day after symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,,,,,,['Fatigue'],UNK,MODERNA, 925332,ME,63.0,F,"11 days post vaccination, patient experienced itching, redness, warmth, and swelling at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/03/2021,11.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 925333,,28.0,F,Warmness and tingling in arm and face. Redness to face and chest. Informed to seek medical help if any further symptoms arise with concern.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,"['Erythema', 'Paraesthesia', 'Rash']",1,MODERNA,IM 925334,MD,42.0,F,Injection site was at the top of the arm with possible injection into the shoulder joint. Approximately 4 hours after the injection the patient began having severe pain and limited ROM of her shoulder.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Arthralgia', 'Injection site movement impairment', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 925335,NH,56.0,F,"7 days post vaccination LUE w/ enlarging red, hot, itchy circular lesion: 6 cm x 4 cm; no fever, ascending lymphangitis. Localized pruritus at site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,OTH,"Atorvastatin, Paroxetine, Lorazepam, Aspirin, Vitamin D",,Hyperlipidemia Anxiety,,NKDA,"['Injection site erythema', 'Injection site pruritus', 'Lymphangitis']",UNK,MODERNA,IM 925336,IL,35.0,M,"""The next couple of days i was extremely tired, slept for several hours in a row and was not even aware of it. 12/23 I started feeling light headed and shakey and couldnt get my heart rate down when attempting a light work out. I felt so bad i took the rest of the week off. 12/30 it hit me again with really bad stomach cramps, fever, light headed and shakey again. i took covid and flu tests and it was all negative. it was so bad i was in bed from new years eve at 9p till 1/1/21 4p and i missed another week of work""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/23/2020,3.0,PVT,,,,,,"['Abdominal pain upper', 'Dizziness', 'Fatigue', 'Pyrexia', 'Tremor']",1,PFIZER\BIONTECH,IM 925337,MS,30.0,F,"Patient became flushed and hot. Cheeks, forehead & nose became red. Nervous. Pulse 102. Resp 20. Administered Benadryl. """,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,None Noted,Asthma,Not Noted,,NKA,"['Erythema', 'Hot flush', 'Nervousness']",1,MODERNA,IM 925338,NJ,23.0,F,"12/29/20 -Sore arm, 12/30/20-12/31/30 sore arm and headaches 1/4/20- 1/5/20 - body aches and headaches, coughing 1/6/20-1/7/20 head aches, body aches, congestion, tiredness, no taste or smell Tested positive for COVID 19",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,WRK,Larissia,,,detected Covid test,,"['Ageusia', 'Anosmia', 'COVID-19', 'Cough', 'Headache', 'Limb discomfort', 'Nasal congestion', 'Pain', 'SARS-CoV-2 test positive']",1,MODERNA,SYR 925339,IN,30.0,M,"Body aches, chills, sweating, nausea, and general weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,None,None,None,,"Sulfa, Penicillin","['Asthenia', 'Chills', 'Hyperhidrosis', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 925340,NY,34.0,M,"Few minutes after vaccine, upon arriving to observation area, patient felt briefly dizzy and diaphoretic. reported slightly scratchy throat. Reports not having breakfast. VS HR 104, hypertense, 94% w/ surgical face mask. Noted to have slight blanching erythematous macules on forehead. No pruritus, SOB, stridor, cough, vomiting, abdominal pain, diarrhea. Symptoms resolved within minutes of onset without intervention. RRT called. - no intervention recommended, patient declined transfer or further intervention, opted for observation. Observed x30 minutes without event and discharged to follow up with doctor.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,antihypertensive (Altase),none,hypertension,,NKDA,"['Dizziness', 'Hyperhidrosis', 'Hypertension', 'Pallor', 'Rash', 'Rash erythematous', 'Rash macular', 'Throat irritation']",1,PFIZER\BIONTECH,IM 925341,MO,58.0,M,Facial redness and tingling sensation,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Erythema', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 925342,CA,30.0,F,"5 days after injection started a light headache. 6 days after injection joint pain, in hips and tailbone. feeling fatigue, nausea. with decreased appetite. Night time of day 6 stomach cramps with diarrhea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,WRK,"Zyrtec, flonase nasal spray",,,,seasonal allergies,"['Abdominal pain upper', 'Arthralgia', 'Coccydynia', 'Decreased appetite', 'Diarrhoea', 'Fatigue', 'Headache', 'Nausea']",2,PFIZER\BIONTECH,IM 925343,MO,58.0,F,"Sore arm, following day fatigue , swollen lymph node right neck and sore axilla on right side. Third day, swollen lymph node to left neck lasting several days . Did not prevent me from doing anything.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Protein shakes, multivitamin, calcium with vit D, probiotic, cranberry",none,"hypertension, hypothyroidism, high cholesterol",,Latex,"['Axillary pain', 'Fatigue', 'Lymphadenopathy', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 925344,GA,32.0,F,"On 12-21-2020, elevated heart rate and persistent 12-22-2020 with chest discomfort. On 12-23-2020, I went to the emergency room because my chest pain got worse and peaked. The ER blood pressure was also elevated 200/100.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/21/2020,1.0,PVT,,,,,Neosporin,"['Chest X-ray normal', 'Chest discomfort', 'Chest pain', 'Electrocardiogram normal', 'Full blood count', 'Heart rate increased', 'Hypertension', 'Metabolic function test']",1,PFIZER\BIONTECH,IM 925345,FL,40.0,F,"First day out had pain behind right ear, thought it was muscle but went into my head, lasted 4-5 days now I have severe tenitus in right ear and my head has not felt right since. Like my hearing hoes in and out. I thought it would go away but it?s been two weeks. My head feels cloudy and my right eye feels messed up like blurry. No other injury have occurred. This all started a day after the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,Vitamins,No,No,,No,"['Ear pain', 'Feeling abnormal', 'Headache', 'Hypoacusis', 'Tinnitus', 'Vision blurred']",1,MODERNA,IM 925347,KY,47.0,F,"Began aching all over around 10:30pm the day of vaccine. The following day (January 6), I experienced 102 fever and violent chills, headache, blurry vision and eye pain off and on throughout the day (alternated acetaminophen and ibuprofen). The following day (today, Jan 7), I have a low grade fever and fatigue with some lung pain, labored breathing. I had COVID the end of Oct into Nov. and lab tests the end of Nov showed antibodies but I continued with the vaccine since it was recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"buspar 5 mg bid, 125 mcg levothyroxin, daily multivitamin",shingles that began Dec 9 and lasted 7 days-started Valtrex within 24 hours,none,,none,"['Chills', 'Dyspnoea', 'Eye pain', 'Fatigue', 'Headache', 'Pain', 'Pulmonary pain', 'Pyrexia', 'Vision blurred']",1,MODERNA,IM 925348,MI,22.0,M,"I have had heavy lungs since the day after receiving the vaccine. It is hard to breathe, and hard to get a full breath. Their is slight discomfort when I inhale.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,MIL,50 MG of Sertraline 150 MG of Bupropion,None,None,,None,"['Discomfort', 'Dyspnoea', 'Pulmonary pain']",1,MODERNA,IM 925349,TX,40.0,F,Headache began 5 minutes after shot. Took 500 mg Tylenol. About 4 hours later began feeling weak and muscle aches. Took 600mg ibuprofen. At 1am had massive headache body aches chills to the core. Took more Tylenol. At 5:30am fever of 100.4 and flu like symptoms. Called into work.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Tamoxifen, biotin, prenatal vitamins",None,History of breast cancer and skin cancer,,None,"['Asthenia', 'Chills', 'Headache', 'Influenza like illness', 'Myalgia', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 925350,TN,62.0,F,"Nausea, fatigue, chills, soreness at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/01/2021,5.0,UNK,"Nexum, progesterone, estradiol, don peridone,",None,None,,None,"['Chills', 'Fatigue', 'Injection site pain', 'Nausea']",1,MODERNA, 925351,MI,22.0,F,"I developed some small areas of rashes all over my body I had a rather large patch behind my right knee and lots of small rashes everywhere concentrated on my arms and lower back. They were all over. I am allergic to penicillin, I don't know and the rash that I got it looked like the one that I get from when I get penicillin. I looked up the ingredients and it seems they have a polyethoglycol like penicillin. I consulted with the nurse at the vaccine station and she suggested cold showers, not get overheated it is not life threatening but it is still going on and some have started scabbing over but they are still here and they are itchy. The nurse also recommended OTC hydrocortisone cream and Benadryl but it has not really effective. I am thinking about going to see my PCP to se of something else can be done about it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,Lexapro 10mg,No,No,,penicillin,"['Rash', 'Rash pruritic', 'Scab']",1,PFIZER\BIONTECH,SYR 925352,IA,27.0,F,"Day 6 post shot: low grade fever, Body Aches, Chills, Tiredness, Headache and nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/05/2021,6.0,WRK,"Prozac, Ibuprofen, Mucinex night time Cold and Flu, excedrine",,Asthma,,,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 925353,NJ,32.0,F,"dizziness, chest pain, shortness of breath",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,none,none,ulcerative colitis,flu vaccine in 2018,none,"['Blood test', 'Chest X-ray', 'Chest pain', 'Dizziness', 'Dyspnoea', 'Electrocardiogram']",1,MODERNA,SYR 925354,OR,56.0,F,"2 hours, after receiving injection, started feeling nausea, slight headache, very slight sore arm; 3-4 hours later took 3 ibuprofen due to the headache. Feeling light headedness. Next morning, sore arm was heavy, headache, body aches, temp 99, and nausea; felt unwell; took 3 ibuprofen. Time off from work to just lay flat and rest for the day.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,Citalopram; Lisinopril; Atorvastatin; Claritin-D; Aspirin 85mg; D3; Gelatin;,None,Asthma; Seasonal Allergies.,,None,"['Dizziness', 'Headache', 'Impaired work ability', 'Limb discomfort', 'Malaise', 'Nausea', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,SC 925355,MI,29.0,F,"I began noticing red spots on both breasts, then chest, stomach, back, and right arm have began to increase in burning sensation with no discoloration. It feels like I have a rash but no redness or swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,SEN,Prenatal and omega-3,,,,,"['Burning sensation', 'Erythema']",1,MODERNA,SYR 925356,KY,33.0,F,Moderna COVID-19 Vaccine EUA 1/6/21 site of reaction began to itch. Patient did scratch the area and itching persists. Patient looked at injection site where a large swollen (3 inch by 1 inch) reddened and swollen area noted. 1 dose of 25 mg benedryl taken around 11 PM on 1/6/21. As of today site (5inch by 2 inch) swollen area noted with and torso itchy. 1/7/21 reddened splotchy areas noted on chin chest top of legs and persistent itching all over. Arm continues to be warm to touch. All reactions appear to be on skin. No difficulty breathing or other reactions noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PUB,Zoloft 25 mg daily,None,Endometriosis,,NKA,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Pruritus', 'Rash macular', 'Skin warm']",1,MODERNA,IM 925357,OH,43.0,F,Left arm burned where injection was given. Tingling/ numbness in left forearm and hand since injection. Twitching in forearm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Hydrochlorothiazide, potassium chloride, buspar, levothyroxine",none,"hypothyriodism, anxiety, high blood pressure",,"amoxicillin, biaxin","['Hypoaesthesia', 'Injection site pain', 'Muscle twitching', 'Paraesthesia']",1,MODERNA,IM 925358,PA,57.0,M,"Developed left lower leg discomfort on day 5 post-vaccination with dose 1 of Moderna COVID-19 vaccine. Developed worsening pain, swelling and mild erythema of the left lower leg distal to the knee over the next 48 hours. Seen on 1/05/2021, and STAT venous duplex ultrasound ordered, which revealed a prominent deep vein thrombosis partially occlusive, partially nonocclusive extending from the left femoral vein distally. Started on anticoagulation with apixiban. No signs/symptoms of pulmonary embolus. No precipitating event that would raise risk of acute DVT (He does not have any open areas of his skin concerning for infection in the leg. No recent injury to the leg. No recent surgeries or period of immobility. No prior personal history of DVT, provoked or unprovoked. He does not smoke. He does drink alcohol in small amounts, to moderate amounts on occasion. No history of alcohol misuse or abuse.). He has chronic HIV infection, well controlled. He does have a family history of DVT (his mother had 1 provoked and 1 non-provoked DVT).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,PVT,"bictegrav/emtricit/tenofov ala (tablet) BIKTARVY 50-200-25 mg, Take 1 tablet by mouth daily. famotidine (tablet) PEPCID 20 MG, Take 20 mg by mouth daily. fexofenadine HCl (tablet) ALLEGRA 180 MG, Take 180 mg by mouth daily as needed. triamc",None,HIV disease (HCC) Diagnosed January 2009. Diagnosed during acute seroconversion. MSM transmission. No history of opportunistic infections. Hyperlipidemia Insomnia Rosacea Allergic Rhinitis to Pollen GERD Erectile dysfunction,,No Known Allergies,"['Deep vein thrombosis', 'Erythema', 'Limb discomfort', 'Pain in extremity', 'Peripheral swelling', 'Ultrasound Doppler abnormal']",1,MODERNA,IM 925359,FL,23.0,F,"Itchiness, chest pain, cough, chills, sneezing, body aches, headaches, shortness of breath, fatigue and spitting up flem.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/04/2020,,PVT,Metformin,None,None,,,"['Chest pain', 'Chills', 'Cough', 'Dyspnoea', 'Fatigue', 'Headache', 'Pain', 'Pruritus', 'Sneezing']",1,PFIZER\BIONTECH,SYR 925360,UT,52.0,F,Cellulitis at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,OTH,Synthroid,NONE,HYPOTHYROIDISM,,NKDA,['Injection site cellulitis'],1,MODERNA,IM 925361,IN,30.0,F,"Fever up to 102, chills, nausea, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,SYR 925362,TX,33.0,F,"dec 30, a 50 cent piece size red raise lump about the size of a tennis ball with a blister at injection site showed up. Dec 31 it was red raised, hot to touch, aprox the size of a soft ball, blister about the size of a small pea, as the day progressed it wrapped around the upper part of my arm doubling in size, still red, hot, swollen. Jan1st. redness is lighter but still spreading reaching into inner arm, swelling still prominent. Jan 1st clindamycin was started. Swell still prominent, redness has lightened a bit but still spreading, Jan2nd, swelling still noted, not near as bad, redness has lightened to pink, still able to see outline of swelling. Jan 3 no redness noted, itching started. jan4-7, no redness or swelling itching off and on, scab where blister was.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/28/2020,5.0,PVT,none,none,none,,"sulfa,pcn","['Condition aggravated', 'Injection site erythema', 'Injection site mass', 'Injection site pruritus', 'Injection site swelling', 'Injection site vesicles', 'Injection site warmth', 'Scab']",1,MODERNA,IM 925363,DC,39.0,F,"Dizziness and weakness - lasting approximately 45 minutes. Slight dizziness continues now (approx 11am) but is subsiding, but continues. Pfizer's information sheet said this may be a sign of an allergic reaction. No medical follow up seems necessary right now, but important to report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"lortidine, flonase, vitamin D",N/A; negative COVID test on 1/3/2021; Returned from travel on 12/30/2020,Asthma,,"seasonal allergies, allergy to mold, dust and pet dander, no allergies to medications","['Asthenia', 'Dizziness']",1,PFIZER\BIONTECH,SYR 925364,PA,49.0,F,Metallic taste in mouth beginning about 10 minutes after injection. Lasted for 1 hour. No treatment. No other associated symtpoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,"valcyclovir, melatonin, magnesium, lithium orotate, zinc, vitamin C, vitamin D",Herpes cold sore 1 week prior,no,,"iodine dye , avocado, CT contrast dye (1988)",['Dysgeusia'],1,MODERNA,IM 925365,,46.0,F,"Received covid shot 1-4-21. Has chills, body aches and runny nose.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PVT,,,,,,"['Chills', 'Pain', 'Rhinorrhoea']",1,PFIZER\BIONTECH,IM 925366,IN,51.0,F,Urinary Tract Infection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Advair 250/50 Tamoxifen Montelukast (singulair),,Asthma and Allergies Breast Cancer (6 years ago),,Penicillin Sulfa Nuts Milk Eggs Dust Pets,['Urinary tract infection'],1,PFIZER\BIONTECH, 925367,ME,70.0,F,"About 10 days after receiving her vaccine, the patient developed redness, swelling and itching at the site of vaccination. It was warm to touch. Patient sought care from PCP, it did not appear to be infected, no antibiotics were prescribed.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,01/03/2021,10.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 925368,NE,38.0,F,"AT APPROXIMATELY 5PM ON DAY OF VACCINATION, DEVELOPED SORENESS IN LEFT ARM. AROUND 10PM SHE EXPERIENCED EXTREME PAIN, COULDN'T LIFT HER ARM OR MOVE THE FINGERS ON THAT ARM. IT ADVANCED TO HER NECK AND BACK, SEVERE HEADACHE, STATING IT FELT LIKE SHE HAD BEEN HIT IN THE HEAD WITH A HAMMER. SHE ALSO FELT HEART POUNDING AND HAD CHEST PAIN. DESCRIBES ALL THE PAIN AS THROBBING. SHE RAN FEVERS (HIGHEST WAS 100.3) AND HAD CHILLS. DIDN'T GET OUT OF BED UNTIL 11:30 THE FOLLOWING MORNING.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,,"['Back pain', 'Chest pain', 'Chills', 'Feeling abnormal', 'Headache', 'Hypersomnia', 'Mobility decreased', 'Neck pain', 'Pain', 'Pain in extremity', 'Palpitations', 'Pyrexia']",1,PFIZER\BIONTECH,IM 925369,KS,40.0,F,"Itching, redness, soreness at injection site, about half dollar size- 1 week post vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,UNK,"Vit C, Vit D, iron co-factors, women's health supplement, magnesium, monolaurin",none,none,,nkda,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,IM 925370,TN,44.0,F,"Itching, swelling, redness larger than size of silver dollar on arm at injection site beginning one week after first dose. Began while exercising on 1/6/21 and continues to worsen as of 1/7/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,OTH,"Vitamin D, elderberry with zinc",no,no,,"gastrointestinal reaction to some dairy (ice cream, milkshakes, cream cheese)","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 925371,NC,39.0,F,Hives and itch all over,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,None,None,Fatty liver,,"Any cillin, sulfa, lasix","['Pruritus', 'Urticaria']",1,MODERNA,IM 925372,TX,31.0,M,"EE called to report symptoms of fever 102.3, general body aches and chills started today at 5.30am Treatment modality include taking Tylenol. He will continue to monitor symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925373,MI,29.0,F,"Pt presented to our office for redness, swelling and painful site where she had received the COVID vaccine from Moderna on 12/29/2020. She presented today, 1/7/2021 with the adverse event. The size of site was approximately 11cm, hard, and warm to touch. She reports immediately after the vaccine, the injection site was slightly painful and sore but went away until 01/04/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/05/2021,7.0,PUB,None,None,None,,Augmentin,"['Immediate post-injection reaction', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",3,MODERNA,IM 925374,IL,60.0,F,"""Hot, flushing, took Benadryl liquid po several doses, i had chest tightness and could not take a full breath until the next morning""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,none reported,,,"Ceclor, Demerol, Tree nuts, Neurontin, Tegretol, Ultram","['Chest discomfort', 'Dyspnoea', 'Feeling hot', 'Flushing']",1,MODERNA,IM 925375,CT,58.0,F,"On day 7 post vaccine (1/6/2021) patient developed itching at the site of the vaccine then was seen today 1/7/2021 for redness and swelling to the site. Patient with 2.5inchx3inch area to lateral arm/lower deltoid region of erythema and induration. Area slightly warm to touch. Area not tender. No abscess or drainage noted. Full range of motion of the extremities noted. Denies any systemic symptoms. Denies any chest pain, difficulty swallowing, shortness of breath, vomiting, dizziness. Patient also endorsed some bilateral lateral pectoral/anterior should soreness - this area slightly tender but patient does endorse exercising and believes it to be related to that. Advised supportive measures at home (warm/cold pack, tylenol or ibuprofen as needed for pain). Patient also given course of keflex 500mg TID for possible early cellulitis. RN will call patient to check on patient in 2 days",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,PVT,,,,,No known food or medication allergies,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity', 'Tenderness']",1,MODERNA,IM 925376,MI,22.0,F,"About 12 hours after the vaccination I started developing a rash. I noticed it at first behind my right knee and as the hours passed it started all over my body, arms, legs, chest, back. It was very itchy. The next day it did not get any better and I went see the nurse at the vaccine clinic at my work where I received the shot at. she looked at the area on my back and arms and legs and suggested Benadryl and OTC hydrocortisone cream. I have been using it but I still have some rash, some areas it is already drying out and scabbing and I believe it is because one of the ingredients of the vaccine is a polyethylene glycol that is also encountered in penicillin and I get bad rashes if administered penicillin. Nothing life threatening but the itching is very aggravating and the rashes not pleasant to look at.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,Lexapro 10mg,No,No,,penicillin,"['Rash', 'Rash pruritic', 'Scab']",1,PFIZER\BIONTECH,SYR 925377,IL,60.0,F,"APPROXIMATELY 24 HOURS AFTER THE INJECTIONS I RAN A FEVER OF 100.7, BODY ACHES OVER ALL JOINTS, EXTREME FATIGUE AND HEADACHE ADN THE INJECTION SITE WAS PAINFUL. I HAD THE COVID VIRUS DIAGNOSED 10/23/2020 WITH THE EXACT SAME SYMPTOMS EXCEPT I RAN A HIGHER TEMP",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,WRK,"TYLENOL, ASPIRIN, MOTRIN",NONE,"HAYFEVER, POLYMYALGIA RHEUMATICA",,NIACIN,"['Fatigue', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 925378,NE,38.0,F,"Moderna COVID-19 Vaccine EUA In arm where vaccine was given: pain, redness, swelling, heat Prescribed cephalexin for suspected cellulitis by my PCP. Currently on day two of a seven day course of treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,Flonase,,lactose intolerance,,,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 925379,FL,39.0,F,"Moderate to severe itching at all prior scar sites, some decades old. Severe itching/discomfort surrounding Nexplanon implant. Previously broken/fractured bones, and site of 20 year old rotator cuff tear, all throb with dull pain as if they are new injuries. General feeling of malaise, lack of appetite, and mental fogginess. All symptoms continue to persist still 48 hours after vaccination. Also experienced fever of approx. 102 degrees for roughly 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,None,None,None,,None known,"['Decreased appetite', 'Feeling abnormal', 'Implant site pruritus', 'Itching scar', 'Malaise', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 925380,NM,33.0,F,"1420: Vaccine administered. 1425: Reported right arm numbness distal from injection site. Circulation intact. ROM intact. 1452: Complains right arm numbness, right hand cooler to touch than left. 1500: Complains of right arm numbness- temp 97.0 Resp 16 HR- 67 BP- 130/85 1515: Reports somewhat improvement of numbness. Temp- 97.2 Pulse- 78 Resp- 16 BP- 124/86 1530: Reports somewhat improvement of numbness. Temp- 97.5 Pulse- 70 Resp- 18 BP- 114/79 1545: Reports right arm still tingling no more or less than previously reported. Temp- 97.1 Pulse- 74 Resp- 17 BP- 116/79",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,Unknown,None reported,,,None reported,"['Hypoaesthesia', 'Paraesthesia', 'Peripheral coldness']",1,PFIZER\BIONTECH,IM 925381,IN,36.0,F,"Immediate headache, lightheaded, increase in blood pressure",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,WRK,,,Lupus,Received IV Benadryl after flu shot several months ago,,"['Blood pressure increased', 'Dizziness', 'Headache']",UNK,MODERNA,IM 925382,FL,39.0,F,"Day of vaccine, quarter-sized red mark at site of vaccination - raised, hot, swollen. Each day size of mark increased to day four at 5 inches wide by 6 inches high. Continues to feel warm and painful. Seen in the ED - given Septra DS in case of cellulitis, and tramadol for pain. Some nausea and vomiting day 3. (possibly from the pain) Patient was positive for COVID19 the week prior to Thanksgiving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"birth control, Topamax, Synthroid",no,"migraines, hypothyroidism",,penicillin (childhood - reaction unknown),"['Nausea', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling', 'Vaccination site warmth', 'Vomiting']",1,MODERNA,IM 925383,WI,64.0,M,Moderate to severe muscle pain at injection site lasting 4-5 days. Overall body aches lasting 2 days. High Fever (over 101) with intermittent periods of chills and then sweating for 48 hours which turned into an nocturnal fever (100.1) the second 48 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Flomax 0.4 mg daily, Zetia 10 mg q HS, Allopurinol 300 mg daily, Vitamin D 2,000 units daily, Aspirin 81 mg daily",Viral sinus infection. Positive Covid one month prior to vaccination.,"Gout, prostatic hyperplasia",,No know allergies.,"['Chills', 'Hyperhidrosis', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 925384,AZ,26.0,F,"PATIENT IS EXPERIENCING BODY ACHES, FATIGUE, NAUSEA, HEADACHE, AND EYE PAIN.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,MIL,BIRTH CONTROL,NONE,NONE,,AMOXICILLIN,"['Eye pain', 'Fatigue', 'Headache', 'Nausea', 'Pain']",1,MODERNA,IM 925385,IN,58.0,F,"low grade fever, rapid heart rate, body aches, joint pain, headache, weakness, fatigue, sore arm, light headed",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,UNK,Unknown,Unknown,Unknown,,Unknown,"['Arthralgia', 'Asthenia', 'Dizziness', 'Fatigue', 'Headache', 'Heart rate increased', 'Pain', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA,IM 925386,NJ,62.0,F,"Slightly dizzy right after the injection. Chills occured. Wthin 4 hours, pressure in chest which went into an irregular heart beat. I went to sleep woke up no irregular beats but severe chills, loss of appetite for 8 days. Lost 5 lbs. Followed up with medical Dr. She told me to contact you and not to take the second shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PUB,"synthroid, HCTZ, beta blocker, calcium channel blocker, vitamin C, vitaminD3",none,"Thyroid removal, 1.2020- had graves disease which created created heart issues",,"aspirin, floxin, anti thyroid medications","['Chest discomfort', 'Chills', 'Decreased appetite', 'Dizziness', 'Heart rate irregular']",1,MODERNA,IM 925387,ME,70.0,F,"About 10 days after vaccination, patient developed an itchy, red and swollen area at the vaccination site. Approximately 20x10 cm and 2 cm thick. Did not appear to be infected.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/24/2020,01/03/2021,10.0,PVT,,,,,,"['Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site swelling']",UNK,MODERNA,IM 925388,KS,65.0,M,Shingles. Next morning,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/1920,,OTH,"Losartin, amalopine",None,Copd,,None,['Herpes zoster'],1,MODERNA,IM 925390,WA,39.0,M,"Extremely sore ""dead"" arm",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Injected limb mobility decreased', 'Pain in extremity']",1,MODERNA,IM 925391,MI,22.0,F,"About 12 hours after receiving the vaccine I noticed some itchy rash behind my right knee. Soon the rash started spreading all over my body. Legs, arms, chest and back. The next day I saw the nurse at the vaccine station at my work where I received the vaccine and she looked at my rashes and suggested cold showers, Benadryl and a hydrocortisone cream. I have been applying it but I still have rashes and some have been drying out and scabbing. It is very itchy and the rashes are not pleasant to look at. I intend to see my PCP to see if something else can be done about the rashes. I was reading about the ingredients and I believe it is a polyethylene glycol that the vaccine has and penicillin has too that probably caused the rashes.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,Lexapro 10mg,No,No,,penicillin,"['Rash', 'Rash pruritic', 'Scab']",1,PFIZER\BIONTECH,SYR 925392,PA,25.0,F,"Fatigue, weakness, lightheadedness, nausea, injection site soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"Larin, culturelle, multivitamin",None,None,,None,"['Asthenia', 'Dizziness', 'Fatigue', 'Injection site pain', 'Nausea']",1,MODERNA,IM 925393,TN,39.0,F,"Moderna COVID-19 Vaccine EUA A rash approximately the 2"" long by 1"" wide developed. It worsened the next day, but then started to go away and is almost completely gone now.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/04/2021,7.0,PVT,"Vitamin D, Multivitamin",None,None,,None,['Rash'],1,MODERNA,IM 925394,IN,28.0,M,"Fever and myalgias started approximately 36hrs after administration. Fever, myalgias, headache, drenching night sweats continued for over 24hrs until approximately 72hrs post administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"Lexapro, Claritin, Tylenol",,Ulcerative colitis Depression,,Pistachios,"['Headache', 'Hyperhidrosis', 'Myalgia', 'Night sweats', 'Pyrexia']",1,PFIZER\BIONTECH,IM 925395,FL,46.0,F,Localized rash- monitoring site,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/07/2021,9.0,PVT,Cozaar Estrodial,None,Hypertension,,None,['Rash'],1,MODERNA,IM 925396,FL,63.0,F,"Temp of 102 with chills and body aches and pains, incision site of left ORIF became red and inflamed and I had to go to the emergency room where I was given doxycycline b.i.d. for seven days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,WRK,"Gabapentin 600 mg bID daily, lisinopril 40 mg daily Synthroid 150 MCG daily Calcium citrate 600 mg daily vitamin D 5000 units daily Lipitor 20 mg daily, Vitamin B 12 50 MCG?s daily, omeprazole 20 mg bid, Hiprex 1gm daily, Trilogy one puff d",ORiF of left fibula,"Barrett?s esophagus, osteopenia, macular degeneration to the right eye, Arthritis, hypertension, hyperlipidemia,",,"Chantex, morphine","['Body temperature increased', 'Chills', 'Dermatitis', 'Erythema', 'Pain']",1,PFIZER\BIONTECH,IM 925397,AZ,42.0,F,"About 1 hr post vaccination, patient developed jittery feeling (like she chugged espresso), cold feeling in the chest. Pt reported eating breakfast and being adequately hydrated. Patient returned to vaccine clinic, remained seated for about 30 minutes, drank water, and feeling dissipated.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,lidocaine (2008) - has had after,"['Feeling abnormal', 'Feeling cold', 'Feeling jittery']",2,PFIZER\BIONTECH,IM 925398,TX,48.0,F,"Pain and soreness in left shoulder and arm. Difficulty lifting arm due to the pain. Pain improved on third day, but still present.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,WRK,none,none,,,none,"['Injected limb mobility decreased', 'Injection site pain', 'Pain', 'Pain in extremity']",1,MODERNA,SYR 925400,,65.0,M,Fever after receiving vaccine - started same day,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,WRK,,COVID positive mid-December,,,,['Pyrexia'],1,PFIZER\BIONTECH,IM 925401,NY,37.0,F,"Sudden onset redness, itching and swelling of left upper arm at injection site and distally extending to elbow, prescribed cephalexin for favored developing cellulitis. Symptoms resolved within 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/06/2021,14.0,PVT,Albuterol inhaler Symbicort inhaler Sertraline cetirizine trazodone Vitamin C,none,asthma environmental allergies depression anxiety irritable bowel syndrome,,oral azithromycin latex,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 925402,CA,26.0,M,"Throat tightness 1 min post vax. Taken to ED from vax site. No meds, observation x 4 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/20/2020,0.0,PVT,,,,,,"['Immediate post-injection reaction', 'Throat tightness']",1,PFIZER\BIONTECH, 925403,AZ,60.0,F,"Vaccine on December 30th @ 8:30 am. Fine all day until 1:00am next morning 12/31 it woke me up with fever, bad body aches hurt to touch me, left arm I couldn't move painful, nausea and bad headache this went on for 2 days(12/31 & 01/01). Next 2 days (1/02 & 1/03) was recovering with just soreness, anxiety and headache(Migraine Med help), tired and shortness of breath9inhaler0. Was like having Covied again.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Tylenol, aspirn",none,none,,"codeine, depo-Medro, flagyl, Percocet, Tylenol with codeine, hydrocodone, fresh fruits, veggies","['Anxiety', 'Dyspnoea', 'Fatigue', 'Headache', 'Injected limb mobility decreased', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'Tenderness']",1,MODERNA,SYR 925404,WI,40.0,F,"0625-Employee began to have elevated heartrate, heart pounding in her chest. Color pale. VS-HR-157, B/P-135/105. O2 sats-100% 0630-Ambulated to ED room. HR-148, B/P-150/83, O2sats-100%. Drank apple juice and ate a cracker. Experiencing dizziness, chills and heart racing. 0640-Hr-105-110, B/P-113/71, O2 sats-100%. Feeling better, shaking incontrollable chills. 0700-HR-104, B/P-121/79, O2 sats-100%. Spoke with ED physician-observe for 1 hour and reevaluate. Denies swelling, itching or difficulty breathing. Her mouth is very dry. Tolerating fluids without issues. 0715-HR-97, B/P-118/70, O2 sats-100%. Continues to experience waves of dizziness and chills. Episodes are spacing out further and not lasting as long. 0730-HR-90's, B/P118/70, O2 sats-100%. Tolerated ambulating to bathroom without problems. States just not feeling herself. Has opted to go to the clinic for evaluation. Assisted to clinic-tolerated ambulating without problems.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Unknown,None known,None Known,,Unknown,"['Chills', 'Dizziness', 'Dry mouth', 'Electrocardiogram', 'Feeling abnormal', 'Heart rate increased', 'Pallor', 'Palpitations', 'Tremor']",1,MODERNA,IM 925405,FL,65.0,F,Pt got hives around neck in complete circumference. Looked like mosquito bites. Itchy,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,bystolic,no,no,,possible sulpha drug allergy,"['Arthropod bite', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 925406,,59.0,M,"high fever, muscle and body aches, headache, fatigue, diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,UNK,"Prezcobix, Descovy, Paroxetine, Carvedilol, Losartan potassium, Ropinirole, Coq10, Stress tabs, Aspirin 81mg, Trazadone, Clopidogrel, Rosuvastatin",,HIV,,omoxicyllan,"['Diarrhoea', 'Fatigue', 'Headache', 'Myalgia', 'Pain', 'Pyrexia']",UNK,MODERNA, 925407,GA,47.0,F,"03:00AM contraction painfully cramps stomach and low back, nausea, felt like throwing up but couldn't chills r side of body pain -stabbing pain feeling, unable to lift arm overhead, felt like head swelling, severe headache; Goody's powder eased headache. 6AM -8PM fatigues, down feeling, loss of appetite, slight windedness, chills, nausea ,headache, r side body in pain severe arm pain. Today only soreness in arm and some cramping in lower back",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Metoprolol and Norvasc, hydrochlorothiazide, lisinopril, Claritin, biotin , albuterol",,High blood pressure,,penicillin and morpheein,"['Abdominal pain upper', 'Back pain', 'Chills', 'Decreased appetite', 'Depressed mood', 'Dyspnoea', 'Fatigue', 'Head discomfort', 'Headache', 'Injected limb mobility decreased', 'Muscle spasms', 'Nausea', 'Pain', 'Pain in extremity']",1,MODERNA,IM 925408,MD,47.0,F,Approximately 30 minutes after vaccination she had swelling and redness in her hands and small hive and redness on her chest. Symptoms lasted for about 2 hours and she took benedryl.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Erythema', 'Peripheral swelling', 'Urticaria']",UNK,PFIZER\BIONTECH,IM 925409,WA,56.0,F,"Patient complained of dizziness, wheezing, cough, and nausea. BP 180/110, P 72, O2 saturation 99% RA; 3:23PM BP 180-110, P 84, O2 sat 99% RA; 3:35PM BP 210/100 P88, O2 sat 98% -- > called emergency services; 4:25PM BP 140/92. Paramedics administered 1 dose 25mg diphenhydramine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,SEN,,,,,,"['Cough', 'Dizziness', 'Nausea', 'Wheezing']",1,PFIZER\BIONTECH,SYR 925410,TN,49.0,F,"Sore injection sight for 3 days. Heart Palpitations started on 1/1/2021. Increased Blood Pressure (prior to vaccine maintained after vaccine my bp increased to 124/97 on Jan 5 and by Jan 6 it was 157/112 pulse 143. Shortness of breath, dizziness, difficulty with breathing after exertion, increased joint pain and muscle weakness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PVT,Carveidilol 25mg Twice Daily Furosemide 40mg Daily Montelukast 10mg At Bedtime Topamax At Bedtime Diclofenac Sodium 50mg Twice Daily Lisinopril 40mg At Bedtime Maximum D3 325mcg Once Week Bupropion ER/SR 150 mg Twice Daily G,Seasonal Allergies,Blood pressure Asthma,,Norvasc Benedryl Doxycycline Augmentin,"['Arthralgia', 'Blood pressure increased', 'Dizziness', 'Dyspnoea', 'Dyspnoea exertional', 'Injection site pain', 'Muscular weakness', 'Palpitations', 'SARS-CoV-2 test negative']",UNK,MODERNA, 925411,CA,36.0,F,"Lightheadedness, chest pain/pressure, flushed skin of chest, tingling BLE > BUE. Taken to ED from vax site. Improved but still with lightheadedness and rash of upper chest. Given IVF and benadryl injx. Observation x 3 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/21/2020,0.0,PVT,,,,,,"['Chest discomfort', 'Chest pain', 'Dizziness', 'Flushing', 'Paraesthesia', 'Rash']",1,PFIZER\BIONTECH, 925412,ME,49.0,F,"After 5 minutes of having the vaccine I experienced right sided tongue tingling followed by a funny taste. 5 minutes after that my arm started itching from the injection site. I took ibuprofen pm that had Benadryl in it to help. I was fine all night after taking the ibuprofen with Benadryl. This morning 1/7/21, I have a sour metallic taste which has not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"I took propanol 10 milligrams prior to taking the vaccine for anxiety. Then after the shot because of the reaction, I took ibuprofen pm with Benadryl in it because I didn?t have regular Benadryl to take.",None,Born with hip dysplasia.,,"Percocet, sulphur drugs, any SSRI meds, and IV contrast","['Dysgeusia', 'Injection site pruritus', 'Paraesthesia oral']",1,MODERNA,SYR 925413,AK,37.0,F,"Extensive pruritus and mild urtiaria with premedication with Benadry, zyrtec and pepcid.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,"Ibuprofen, eggs, shellfish","['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 925414,FL,50.0,F,Headache fever chills aches nausea vomiting dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PVT,None,Cancer survivor,Gluten allergy,,Milk acetometiphan codeine products z pack antibiotics,"['Chills', 'Dizziness', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",1,MODERNA,SYR 925415,WI,59.0,M,"Fatigue, Dizziness, Sore Arm at the administration site onset-morning after adminstration",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"Meloxicam, Atorvastatin, Ibuprofen, pepcid, aspirin",none,GERD,"Seasonal Influenza, 9/22/20, Flulaval, fatigue, dizziness, sore arm",Codeine,"['Dizziness', 'Fatigue', 'Injection site pain']",1,PFIZER\BIONTECH,IM 925416,PR,23.0,F,"Chills, headache, generalized pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,,,Hypothyroidism,,,"['Chills', 'Headache', 'Pain']",UNK,PFIZER\BIONTECH, 925417,NY,31.0,F,"one week after the vaccination the injection site became red, hot and tender to touch, and mild soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"levothyroxine, junel 1.5",,"hashimoto hypothyroidism, mild asthma, eczema",,"sulfa, peaches","['Injection site erythema', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 925418,NY,46.0,F,"Received the Vaccine on a Monday morning, Next day started with a bad cold. By Tuesday night I had to use my inhaler, take cold/cough medicine to help me stop coughing. By Wednesday Had a bad cough, tightness in the chest, and lots of congestion. Left arm was very sore. Called work who told me to go to the ER for covid test. Tried to get into my doctor's office who would not see me and told me to get a covid test. Tried to get into Facility who told me I would require two appointments. One to see a doctor and another to get a Covid test. Also, it would be a three to four-hour wait. Felt so sick that I took myself to an ER in order to be seen. Mysaturation was good in the ER but HR was in the 120s. They did an EKG, gave me an albuterol inhaler, IV fluids, IV steroids, and a chest X-ray. They did a Covid test which was negative as well as other bloodwork. Then sent me home. My husband also started with a cold the Sunday night before my vaccine so I do not know if that might have been where I got sick?",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,Metformin Januvia Valsartan with Hydrochlorthiazide Levothyroxine Zocor Vit E,,"Asthma, HTN, Hypothyroid, Type 2 Diabetes",,Bactrim,"['Blood test', 'Chest X-ray normal', 'Chest discomfort', 'Cough', 'Electrocardiogram', 'Heart rate increased', 'Malaise', 'Nasopharyngitis', 'Pain in extremity', 'Respiratory tract congestion', 'SARS-CoV-2 test negative', 'Urine analysis']",1,PFIZER\BIONTECH,SYR 925419,ND,25.0,M,Sore arm/injection site began roughly 4 hours after receiving vaccine. No treatment used. Pain continue into second day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,UNK,Emtricitabine / Tenofovir (Truvada) Fish Oil Multivitamin,,,,,['Injection site pain'],1,MODERNA,IM 925420,FL,39.0,F,"Starting the day of vaccination (1/4/21), patient developed quarter-sized red spot at injection site (hot, swollen, painful). Reaction continued to progress daily to dark red 5 inch by 6 inch circular mark on day 4. Patient experienced N/V day 3 as the result of the pain. Patient went to the ER 1/7/21, and received Bactrim in case of cellulitis and tramadol for pain. (Of note, the patient was positive for COVID19 the week of November 15th)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Topamax, Synthroid, birth control",no,"migraine, hypothyroidism",,penicillin (reaction unknown),"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 925421,CA,39.0,F,"Sxs 10 minutes post vax with nausea, lightheadedness, flushed. Taken to ED from vax site. Given IVF, Zofran inj.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/23/2020,0.0,PVT,,,,,,"['Dizziness', 'Flushing', 'Nausea']",1,PFIZER\BIONTECH,IM 925422,,59.0,F,"Client came to observer 30 minutes post vaccination stating she felt light headed. Clinic lead staff assessed indicating client weak, dizzy, flushed and diaphoretic. EMS called. Epinephrine .3 mg administered by auto injector. EMS arrived, assessed client, encouraged client visit walk in clinic for evaluation and released client. Client left clinic stating she felt fine and walked unassisted out of building.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,codeine,"['Asthenia', 'Dizziness', 'Flushing', 'Hyperhidrosis']",1,MODERNA,IM 925423,AZ,40.0,M,"PATIENT IS EXPERIENCING A HIGHER FREQUENCY IN THEIR ALLERGIC SYMPTOMS. SNEEZING, MODERATE LETHARGY, CONGESTION, ALLERGIC RHINITIS",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,MIL,OTC ZYRTEC,NONE,ALLERGIES,,"LATEX, NEOSPORIN","['Hypersensitivity', 'Lethargy', 'Respiratory tract congestion', 'Rhinitis allergic', 'Sneezing']",1,MODERNA,IM 925424,ME,74.0,F,Vaccine given outside of schedule. Dose 1 administered on 12/21/2020. Dose 2 Administered on 1/7/2021 (Day 16),Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Unknown,,"Asthma, Hypertension",,None Known,['Inappropriate schedule of product administration'],2,PFIZER\BIONTECH,IM 925425,NJ,38.0,F,Infection at injection site. Enlarged painful axillary lymph node.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PHM,Synthroid Lo Loestrin Singluair Flonase Daily multivitamin Melatonin,At the time of my vaccination I was unaware that I was suffering from gallstones.,Hashimoto Hypothyroidism Asthma,,None,"['Blood test', 'Injection site infection', 'Lymph node pain', 'Lymphadenopathy', 'Ultrasound scan']",1,MODERNA,IM 925426,CA,27.0,F,"Dizziness, blurred vision, nausea. Taken to ED from vax site. Given IVF, Zofran inj.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/23/2020,0.0,PVT,,,,,,"['Dizziness', 'Nausea', 'Vision blurred']",1,PFIZER\BIONTECH, 925427,TX,49.0,F,"Nausea, tick to mouth, headache, muscle aches, fatigue, bruising, chills and low grade fever of 99.4 beginning at 8PM on 1/6/2021. Vaccine given at 7:30 AM on 1/6/2021. Still experiencing body aches as of 10am on 1/7/2021 but all other symptoms have improved. No treatments given.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,,,,Similar reaction occurred after 1st dose of the COVID vaccine.,,"['Chills', 'Contusion', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Tic']",2,PFIZER\BIONTECH,IM 925428,CO,28.0,M,"I got the shot and immediately started feeling shooting pain down my arm. It was given at high angle and higher on the arm than I have ever gotten a vaccine. I have had severe shoulder pain shooting down. my arm and into my wrist since then, lost 80% mobility without pain, and have trouble sleeping. I went to the ER where an ultrasound showed nothing. I went to my PCP four hours later, then my occupational health clinic an hour later. I took a ton of steroids which helped slightly, but the pain has returned.",Not Reported,,Not Reported,Not Reported,,Yes,N,10/15/2020,10/15/2020,0.0,WRK,,,,,,"['Arthralgia', 'Insomnia', 'Mobility decreased', 'Pain', 'Product administered at inappropriate site', 'Sleep disorder']",1,UNKNOWN MANUFACTURER,IM 925429,KS,59.0,M,"Left Chest Pain that was sharp for about 5 minutes. Blood pressure initially was 196/96. Blood pressure came down, and I completed a full day of seeing patients. I then reported in the evening to the ER for testing. No Heart Attack or Blood Clot was diagnosed. So, this was musculoskeletal pain at the left costochondral region.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/21/2020,3.0,PVT,None,None,None,,None,"['Blood test', 'Chest X-ray', 'Chest pain', 'Electrocardiogram', 'Hypertension', 'Musculoskeletal chest pain']",1,PFIZER\BIONTECH,IM 925431,ME,27.0,F,Rubor experienced on right arm at the site of injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,PVT,,,,,,['Injection site erythema'],1,MODERNA,IM 925432,IL,63.0,F,"Received the vaccine on 12/29/20 and noticed by arm was tender for two days and subsided. This morning 1/07/20 noticed my Left arm had redness around injection site 6 1/2 cm wide by 9 1/2 cm in length. My left arm is warm, swollen, and a little tenderness when I touch it.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/07/2021,9.0,WRK,"Lisinopril/HCTZ 10/25 mg, Calcium 1200 mg, Vitamin D",No,Hypertension,,No Known Allergies,"['Injection site erythema', 'Peripheral swelling', 'Skin warm', 'Tenderness']",1,MODERNA,IM 925433,WY,49.0,M,"at injection site- pain, bruising small swelling. treatment warm moist packs next day some reduction of all symptoms at 48hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,omeprazole,,,,tetanus anti toxin,"['Injection site bruising', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 925434,MD,74.0,F,"Headache, dizziness, chest tightness, scratchy throat; No treatments provided in clinic. Patient monitored until EMS arrived. Patient care handed over to EMS.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,MIL,,,,,,"['Chest discomfort', 'Dizziness', 'Headache', 'Throat irritation']",2,PFIZER\BIONTECH,IM 925435,CA,54.0,F,"Sxs 90 minutes post vax. SOB, palpatations, nausea, tachycardia. Presented to ED. CXR/EKG normal, labs normal, given Zofran inj.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/24/2020,1.0,PVT,,,,,,"['Chest X-ray normal', 'Dyspnoea', 'Electrocardiogram normal', 'Laboratory test', 'Nausea', 'Palpitations', 'Tachycardia']",1,PFIZER\BIONTECH, 925436,NY,61.0,F,"upper left arm has a large red area, firm, warm to touch, itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,"Simvastatin, Lisinopril, Atenolol, Multivitamin, Super B vitamin, Vitamin D 3, Calcium, Vitamin C, Vitamin B12",none,"Hashimotos, Hyperlipidemia, Hypertension",,Avalox,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth', 'Reaction to preservatives']",1,MODERNA,IM 925437,FL,59.0,F,"Itching, redness, swelling, heat at injection site. Continues to itch occasionally.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,WRK,"lexpro, wellbutrin",none,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 925438,FL,67.0,M,Pt had a freezing sensation on arm that was injected and both feet felt like the were frozen in blocks of ice.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Simvastatin,no,no,,no,"['Feeling cold', 'Peripheral coldness']",1,PFIZER\BIONTECH,IM 925439,TX,22.0,F,"1/5/21 received shot around 12:00pm. a few hours later left arm pain started. 1/6/20 left arm pain still there, nausea started. late afternoon, slight body aches started. 1/7/21 woke up with severe body aches. headaches. throat is extremely sore and red. nauseated. chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,150MG bupropion 10MG amphetamine,none,none,,none,"['Chills', 'Headache', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Pharyngeal erythema']",2,MODERNA,SYR 925440,CO,60.0,F,30-40 min felt flush skin on body face bright red. Numbness tingling in hands and feet. Took some advil. Over next two days on and off hot flashes tingling numbness on hands and feet. Very cold feet couldn't get warmed up till wrapped up on heating pad. �o fever but felt chills. Sore arm site of injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,UNK,"Warfarin. Lisinopril, trulicity,allopurinol, jenuvia, oxybutrin, bit D ,glimerperide, omperizole",,"Hc of PE s. Multiple , bilateral 3 years ago. Type 2 DM. Hx of gout",,,"['Chills', 'Erythema', 'Flushing', 'Hypoaesthesia', 'Injection site pain', 'Paraesthesia', 'Peripheral coldness']",2,PFIZER\BIONTECH,IM 925441,IN,50.0,F,"Chills, fatigue, nausea, dyspnea, fever, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,"Singulair, aspirin, multivitamin, cinnamon, vit B2, vit D3, magnesium, turmeric",None,Asthma,,Artifical sweeteners,"['Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia']",UNK,MODERNA,SYR 925442,MA,67.0,F,"I received the vaccine yesterday 1/6/21. Today, 1/7/21, I went for my walk this morning and felt off balance/swayed to the right a bit at one point. I don't think lightheadedness precipitated this, but it unnerved me. I steadied myself and finished the walk without a problem. I checked and surface/pavement was uneven. My temp is 97.5 and I feel fine now but am just a little nervous that is a possible reaction to the vaccine. I had a reaction to the second dose of the hepatitis B vaccine 10 yrs ago, I fainted in early morning hours after getting up to go to bathroom. I had received the second dose at about 11:30a the day before, and developed flu like symptoms by afternoon with a fever and ended up dehydrated which I think contributed to my fainting at about 3a when I got up to void. I had a concussion and was treated with IV fluids at the local ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"levothyroxcin 50mcg, q.d., metoprolol 50mg, q.d., Aspirin 81 mg, q.d., calcium, 500 mg, 2 tabs b.i.d., Vitamin D3, 2000iu, 2 tabs, probiotic daily, vitamin E 300mg, daily, Fish oil 1 tab, bid, Zinc citrate, daily, lutein/zeaxantin two tab",none,High blood pressure Hypothyroidism,"I had a reaction to the second dose of the hepatitis B vaccine 10 yrs ago, I fainted in early morning hours after getting up to ",? Allergy to adjuvant in Hepatitis B vaccine,"['Balance disorder', 'Nervousness']",1,MODERNA,IM 925443,TX,70.0,M,"EE report pain at the injection site , malaise, headache and joint pain. He took Tylenol and symptoms resolved within 6 hours. He is working today 01/07/21 and feels fine with no complaints",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Arthralgia', 'Headache', 'Injection site pain', 'Malaise']",2,PFIZER\BIONTECH,IM 925445,IN,34.0,F,"Vomiting- onset 35 mins from injection, stopped 1 hour after injection Nausea- onset 35 mins from injection. Lasted about 48 hours from injection. Fatigue- onset about 12 hours after injection. Lasted about 48 hours from injection Headache, moderate- onset about 12 hours from injection. Was intermittent for 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,"Symbicort, tylenol",None.,Asthma,,Bupropion,"['Fatigue', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 925446,AL,24.0,F,headache resolved within 15 minutes of observation,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,['Headache'],1,PFIZER\BIONTECH,IM 925447,KY,77.0,F,"Softball size, raised, red area with warmth around the injection site. (Right Deltoid) Started on Keflex 500mg TID X 7 days and ice packs to area until redness resolved Reaction on 12/27/20 Resolved on 1/3/2020",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/27/2020,5.0,SEN,Aspirin 81mg Zinc 50mg Multiple Vitamin,Covid-19 positive on 12/4/2020,Parkinson's Disease Anxiety Hypertension Hyperlipidemia Major depression disorder,,Thorazine,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 925448,WI,24.0,F,"Elevated blood pressure, tingling of the tongue within a few minutes of receiving the vaccine. Sent to ED and treated with Benadryl 25mg. Followed up at 10:15am 1/7/2021 and she is doing ok.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Zofran, Sumatriptan and Ibuprofen",Migraines,,,nka,"['Blood pressure increased', 'Paraesthesia oral']",1,MODERNA,IM 925449,,48.0,F,left hand numbness - resolved spontaneously followed by headache and HTN all resolved spontaneously,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,NKDA,"['Headache', 'Hypertension', 'Hypoaesthesia']",UNK,PFIZER\BIONTECH, 925450,AK,39.0,F,Pt felt throat begin to tighten,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,Bee stings,['Throat tightness'],1,MODERNA,IM 925451,FL,70.0,F,8 hours after the injection I got a terrible headache. Then severe chills that were at the core of my insides. They were so painful. Then body aches and a sore arm. This lasted until today 1/7/2021. I still have a slite headache. I took Tylenol and Advil. Nothing helped.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,none,none,pneumonia/ asthmas,,none,"['Chills', 'Headache', 'Pain', 'Pain in extremity']",UNK,MODERNA,IM 925452,TX,48.0,F,Left arm redness swelling hotness itching and pain one full well after injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,Birth control kurvelo,None,None,,None,"['Erythema', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Skin warm']",1,MODERNA,SYR 925453,VA,27.0,F,"heart rate of 140, chest pain sharp right side of chest. started two hours after vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Aldactone, Bentyl",none,migraines,,none,"['Chest pain', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 925454,MT,46.0,F,"Migraine, lethargy and lower back muscle spasms reported by patient",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,SEN,fioricet prn for migraines,,Migraines ~2x per year,,,"['Condition aggravated', 'Lethargy', 'Migraine', 'Muscle spasms']",1,MODERNA,IM 925455,IA,86.0,F,RESIDENT COMPLAINS OF BODY ACHES AND HURTS TO MOVE. RESOLVED WITHIN 24 HOURS.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,SEN,,,,,,['Pain'],1,PFIZER\BIONTECH,IM 925456,MD,,F,"Following day after vaccine in the morning I experienced Fatigue, Low grade fever 100.5, Chills and muscle ache. I was also very Tired. I took some tylenol. 1/7/21 Im feeling better temp 99.8",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,WRK,"Calcium, prolee injection",no,osteoporosis,,sulfa,"['Chills', 'Fatigue', 'Myalgia', 'Pyrexia']",1,MODERNA,SYR 925457,TN,56.0,M,"Pt diagnosed with COVID-19 on 12/9/2020 (symptom onset 12/6). Had fully recovered and completed isolation period. Had vaccine on 12/27, developed fatigue, dry cough and mild SOB after that. Developed chest pain (substernal stabbing discomfort) on 12/28 and presented to ED on 12/29. Work up was benign. Pt discharge home that same night.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,12/28/2020,1.0,PUB,"Montelukast; doxycycline, omeprazole",Pt diagnosed with COVID-19 on 12/9/2020 (symptom onset 12/6).,GERD,,erythromycin,"['Atelectasis', 'Chest X-ray abnormal', 'Chest pain', 'Cough', 'Dyspnoea', 'Electrocardiogram normal', 'Fatigue', 'Laboratory test normal', 'Pneumonitis', 'Pulmonary fibrosis']",1,MODERNA,IM 925458,CA,54.0,F,"Considerable swelling, redness, warm to the touch",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,WRK,"multivitamins, valacyclovir, lisinopril, glucosamine, fish oil, biotin",high blood pressure,high blood pressure,,bee polen,"['Erythema', 'Skin warm', 'Swelling']",1,MODERNA,IM 925459,CT,36.0,F,"Signs: localized injection site hive in addition to smaller hives on both legs and a dime-sized hive to the face. Symptoms: 1:00 am shooting pain with complete numbness to the contralateral arm which lasted approx. 2 minutes and completely resolved. 4am sweats & chills, but afebrile. Itching to a very small area on the left pointer finger almost immediately after receiving the shot, but this resolved by around 10pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Loratadine 10mg, daily",None known; however - experiencing generalized hives over the past month. Covid test was negative and the hives were resolved prior to 1/6/21. I have been taking the Loratadine 10mg for approximately 2 weeks.,None,,"Latex - generalized hives Food sensitivities to raw vegetables and some fruits - produces generalized hives, but only when immunity is compromised for another reason.","['Chills', 'Hyperhidrosis', 'Immediate post-injection reaction', 'Injection site urticaria', 'Pain', 'Pain in extremity', 'Pruritus', 'Pyrexia', 'Urticaria']",1,MODERNA,IM 925460,NY,36.0,M,"Very sore including flank pain, weak and very tired. The tiredness and side pain resolved within 24 hours. There was swelling and hardness to the injection site. The injection site became a red circle with raised bumps that lasted for 9 Days. The site was itchy and irritated days 4-9. The site on day 10 appear to be back to pre vaccine status.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/27/2020,1.0,PVT,None,None.,Mild Hypertension.,,No known allergies.,"['Asthenia', 'Fatigue', 'Flank pain', 'Injection site induration', 'Injection site irritation', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling']",1,MODERNA,IM 925461,CT,31.0,M,"within 6-8 hours started with holocephalic headache, myalgia, low-grade temp and chills, nausea and fatigue. Incident last ~ 24 hours then abated with Tylenol and Advil",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,none,none,none,,none,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925462,OH,42.0,F,"Vaccine received on 12/23. Pt reports diarrhea on 12/25. On 1/2, injection site became swollen, warm, and itchy. on 1/3 the swelling greatly increased and PCP was notified. PCP saw patient on 1/4 and gave her a steroid shot and antibiotics for possible cellulitis.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/25/2020,2.0,PVT,None provided,unknown,unknown,,NKDA,"['Diarrhoea', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 925463,PA,36.0,M,"Right frontal headache and pain progressively. OTC medications dulled the pain, but it continued despite conservative management with OTC medications, rest, and increase in fluids.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,,,,,,['Headache'],UNK,MODERNA,IM 925464,NC,59.0,F,"Day after the vaccine all day long I felt light headed, like an out of body event,I did not like the way I felt. Dizziness and weaker than normal. Approx. 26 hours later I lost my sense of taste and my eye site was blurred and it is still today Jan. 7, 2021. My taste buds are still not back . My tongue feels rough and I am almost feeling like I have Gerd. A lot of saliva but sour like. Headache , dizzy like and sore arm on day 2all day long.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SCH,"Vitamin D, daily vitamin, Mobic, 20 mg adderall(I took the adderall after lunch","loose bowels, headache, body aches, weakness occasional shortness of breath","Arthritis, adhd",,"reaction to latex and cephalexin, seasonal allergies","['Ageusia', 'Asthenia', 'Autoscopy', 'Condition aggravated', 'Dizziness', 'Dysgeusia', 'Gastrooesophageal reflux disease', 'Headache', 'Pain in extremity', 'Salivary hypersecretion', 'Tongue rough', 'Vision blurred']",1,MODERNA,IM 925465,IN,55.0,F,"Bad headache after vax then 1 day later received the Shringrex vaccine. Dr advised her that it was okay to receive Shringrex vaccine even though just received the Moderna vaccine a day before. After Shringrex vax, headache became worse, started to feel fatigued. Whole body felt like it was burning from the inside out, felt like it was on fire, excessive amount of sweating.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Phenytoin, Citalopram, multivitamin, calcium",,epilepsy,,iodine,"['Burning sensation', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Inappropriate schedule of product administration']",UNK,MODERNA,IM 925466,CT,48.0,F,"Swelling, redness, hardness, and itching at injection site. Headache, fatigue. S/sx have persisted for a 10 days thus far.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,"Pantoprazole, Zoloft, lisinopril, multivitamin, calcium, B-12",None,"Hypertension, anxiety, depression",,None,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site indentation', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 925467,AR,39.0,M,"FEVER,CHILLS,FATIGUE",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Chills', 'Fatigue', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925469,WI,53.0,F,"Day following vaccination had significant diarrhea and nausea. Lasted about 24 hours. Then 7 days after vaccination, 1/6, awoke with large reddened area at injection site, warm to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"Vit D daily, ambereen, claritin",none,"seasonal allergies, IBS",,codeine,"['Diarrhoea', 'Injection site erythema', 'Injection site warmth', 'Nausea']",1,MODERNA,IM 925470,NY,61.0,M,Muscle pain and 100.7 fever,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,SCH,water pill for prostrate,none,none,,possible Penicillin,"['Myalgia', 'Pyrexia']",UNK,MODERNA,IM 925471,NY,22.0,F,quarter sized red bump on the upper left arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"gianvi, victoza",none,none,,None,['Injection site swelling'],1,MODERNA,IM 925472,TN,44.0,F,I develop COVID-19 after vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/22/2020,1.0,WRK,"Zyrtec , B complex, Permian, Vitamin B and C, Fish oil",I was experiencing a headache prior.,I have endometriosis.,,Surfer drugs,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 925473,WI,44.0,F,"5d after vaccine I developed a R sided trigeminal neuralgia of branches 1 & 2. By d10 I developed the rash consistent with herpes zoster, including ophthalmic involvement of the R eye. I have not previously had shingles, but did have varicella as a child. I went to the ER as it was the middle of the night on the weekend and as a physician I realized the eye involvement required immediate treatment. I have since had to see the ophthalmologist x2. The shingles itself is improving, and the eye has healed with steroids and valtrex. I did still receive my 2nd booster shot on 1/5/21 and thus far have not had any additional effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/22/2020,5.0,PVT,none,none,migraines,,ragweed,"['Ophthalmic herpes zoster', 'Rash', 'Trigeminal neuralgia']",1,PFIZER\BIONTECH,IM 925474,KY,49.0,F,"Moderna COVID 19 Vacdine EUA Achy skin, broke out in sweat, nausea, fever, headache, trouble sleeping",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,"Lisinopril 10 mg, baby aspirin, otc prilosec",Had COVID 19. Symptoms began on Dec 18 2020,Hypertension,,Bactrim,"['Headache', 'Hyperhidrosis', 'Insomnia', 'Nausea', 'Pain of skin', 'Pyrexia']",UNK,MODERNA, 925475,IA,66.0,F,"WENT TO SLEEP ON 1/6/21 WITHOUT ANY ADVERSE EVENTS. WHEN AWOKE ON 1/7/21 AT 07:00AM, HAD A RASH ON ARMS AND BELLY. RASH IS NOT ITCHY.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/01/2021,,SEN,,,,,,['Rash'],1,PFIZER\BIONTECH,IM 925476,VT,36.0,U,Head ache day after vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,,,,,,['Headache'],UNK,MODERNA, 925477,ME,46.0,F,Left arm (where pt received injection) warm yesterday and today red and indurated. Took benadryl this AM with no effect. ER evaluation: redness and reaction on L upper arm 8 days post COVID vaccination. Cellulitis of left upper extremity with Vaccine reaction. Treated with Cephalexin 500 MG 4 times daily �and discharged.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/07/2021,8.0,OTH,metoprolol tartrate 25 MG Tab Levonorgest-Eth Estrad 91-Day (SEASONIQUE) 0.15-0.03 &0.01 MG Tab levoTHYROxine 25 MCG Tab albuterol HFA 108 (90 BASE) MCG/ACT AERs,none known,H/O seasonal allergies Dysmenorrhea Acquired hypothyroidism Obesity (BMI 30.0-34.9) Palpitation,,Gluten Lactose,"['Cellulitis', 'Injection site erythema', 'Injection site induration', 'Injection site reaction', 'Injection site warmth']",1,MODERNA,IM 925478,TX,50.0,F,"Large raised area at injection site, accompanied by redness. Did not start until 7 days after the dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,WRK,none,none,none,,none,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 925480,IN,44.0,M,"Joint achiness started approximately 5 hours after the shot, then a severe head-ache started at 2am (8-9/10). This was followed by a fever of 102.7 via temporal scanner that lasted 30+ hours (on Tylenol and Ibuprofen). Nausea was intermittent, HA and Fever were constant for approximately 30 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Vitamin D, Zinc",None,None,,None,"['Arthralgia', 'Headache', 'Nausea', 'Pyrexia']",1,MODERNA,IM 925481,IN,51.0,F,Urinary Tract Infection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Advair 250/50 Tamoxifen Montelukast (generic singular),,Asthma Allergies Breast Cancer - 6 years ago,,Penicillin Sulfa Eggs Nuts Milk Cats Dogs Dust,['Urinary tract infection'],1,PFIZER\BIONTECH, 925482,NY,54.0,F,Significant nasal congestion for several days. No nasal discharge.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,Red Rice herbal supplement Losartan Metformin Cod Liver oil capsules,,Hypertension Diabetes Mellitus II,,Seasonal allergies Dust,['Nasal congestion'],1,PFIZER\BIONTECH,IM 925483,FL,67.0,M,One hour after the shot I became very light headed. I had a difficult time walking. My heart felt like it was racing. My left arm where the shot was given is sore 22 hours later,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,"AMLODIPINE BESYLATE 10 MG TAB TABLET blood pressure ATORVASTATIN 80 MG TABLET high cholesterol, ELIQUIS 5 MG TABLET afib blood clots EZETIMIBE 10 MG TABLET high cholesterol FLUOXETINE HCL 40 MG CAPSULE depression Changed to( Sertraline",None,Heart,,Amoxicillin-pot clavulanate,"['Dizziness', 'Gait disturbance', 'Injection site pain', 'Palpitations']",1,MODERNA,SYR 925484,CA,34.0,F,"3 hours after injection, soreness and pain on the arm, light headedness, dizzy, tired and headache, night of vaccine-- > day 1 after vaccine-- > headache , soreness on the arm, chills, sweats, body is hot, heart pressure day 2 after vaccination (AM) chest (feels like costcochondritis)",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,WRK,,,,,,"['Body temperature abnormal', 'Cardiac discomfort', 'Chills', 'Costochondritis', 'Dizziness', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Pain in extremity']",1,MODERNA,IM 925485,,22.0,M,"Moderna COVID-19 Vaccine EUA Fever & nausea (24 hours), pain injection site (72 hours), headache, body aches, fatigue (48 hours)",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,UNK,,,,,Anaphylaxis to peanuts and tree nuts,"['Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA, 925486,WI,38.0,F,"Headache, extreme fatigue, extreme exhaustion with sleepiness, and nausea. Pain from injection site up to neck and across to head.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,,,,,"vancomycin, sulfa","['Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Neck pain', 'Somnolence']",1,MODERNA,IM 925487,IN,39.0,M,"Headache, fatigue, sore eyes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,UNK,"Hyzaar, omeprazole, ibuprofen, asa","Covid 19, 1st round",,,Amoxicillin,"['Eye pain', 'Fatigue', 'Headache']",2,PFIZER\BIONTECH,IM 925488,CO,41.0,F,Moderate joint aches and nausea. Started 18 hours after the vaccine and lasted 24 hours. Very sore right arm lasting about 72 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,Levothyroxine Citalopram Adderrall,None,None,,None,"['Arthralgia', 'Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 925489,FL,26.0,F,"At approx 0700 on 1/6/2021, I had severe pain in my left axillary lymph nodes. Pain is still present.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Metformin, synthroid, birth control",,"Hashimotos, PCOS",,Ciprofloxacin,['Lymph node pain'],2,PFIZER\BIONTECH,IM 925490,PA,44.0,F,"Injection given 12/26/2020. On 1/2/2021 around 1:40 pm injection site erupted into a painful, red, itchy hot rash. Seen in Urgent Care on 1/3/2021 where doctor diagnosed probable cellulitis and advised time off of work. Given antibiotics and steroid cream to treat. Seen for follow up with same doctor but in occupational health on 1/6/2021. Doctor extended course of antibiotics and did not release me for work. At time of this writing, I am still being treated and my next appointment with occupational health is 1/14/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,PVT,Levothyroxine 25 mcg/day Mirena IUD Duac face cream Lorazepam 0.5 mg at night Vitamin D3 4000IU/day Vitamin B12 2500 mcg/day Albuterol inhaler as needed (not taken recently),,Hashimotos thyroid Anxiety (exacerbated after Mirena insertion) Mild asthma Mild pollen allergies Slightly high cholesterol,,"Prometrium (hives) Pollen, especially tree (upper respiratory reactions) Nickel (contact rash) Spironolactone (not tolerated, but not true allergy)","['Cellulitis', 'Impaired work ability', 'Injection site reaction', 'Injection site warmth', 'Rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,SYR 925491,TX,38.0,F,"8 days after my injection I developed a large red, swollen, hot, raised circle at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,PVT,Prilosec 2X a day Plexus Bio Cleanse 2X a day,,Hashimoto's Disease,,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 925492,FL,63.0,F,"2 days after injection Swelling, redness, warm, itchy to left arm, then 1/6 red swollen and itchy, area getting bigger. 1/7 swelling, turning more red and burning, hot to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,Multi Vitamin; Probiotic; Fish Oil; Lisinopril; CoQ-10; Osteo Bi Flex,Arthritis; High Cholesterol,Arthritis; High Cholesterol,,None,"['Burning sensation', 'Erythema', 'Peripheral swelling', 'Pruritus', 'Skin warm']",1,MODERNA,IM 925493,DC,33.0,F,"About 12 hours after receiving the shot, I woke up with chills, body aches, and nausea. Fever peaked at 100.4. Could not sleep for 4 hours, probably related to the fever. Took 400mg of motrin after 2 hours of fever, temperature was normal by 10 am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,none,none,none,,none,"['Chills', 'Nausea', 'Pain', 'Pyrexia', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 925494,PA,41.0,F,"Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then itchy throat, probably about an hour, as that got worse throat started swelling. Took 50mg prednisone 2 benadryl and albuterol inhaler. Breathing got better and hives went away but still had swollen throat and took pepcid. Headache afterwards but that's typical of an allergic reaction. I can't be sure it was from the vaccine or not but nothing I did yesterday would normally trigger that reaction",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/06/2021,2.0,SEN,"Zyrtec, symbicort, melodic, omeprazole, and Ashwagandha",Asthma,Asthma,,Fruits vegetables soy milk bleu cheese walnuts plants,"['Anaphylactic reaction', 'Headache', 'Pharyngeal swelling', 'Respiratory tract congestion', 'Sneezing', 'Throat irritation', 'Urticaria', 'Wheezing']",1,PFIZER\BIONTECH,IM 925496,IA,56.0,F,Extreme debilitating headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Thyroid, Daily Vitamin, Albuterol Inhaler",None,Asthma,,"Darvon, Singulair, PABA, ?Latex",['Headache'],1,MODERNA,IM 925497,TN,54.0,F,"Pt stated she felt dizzy and lightheaded. She laid down and VS were taken. BP 120/85, HR 67. Pt recovered and left.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,,,auto immune disorder,,,['Dizziness'],1,PFIZER\BIONTECH,IM 925498,OH,64.0,F,"fever 100.6 chills diarrhea x3 days decreased appetite x 3 days brick on chest, resolved after first day weak sinus drainage nausea x 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PUB,"Humera, Lefiunomive, Simvistatin, Hydoxychloroquine, Vitamin D3, Calcium, Multivitamin, Iron, tylenol prn",RA,RA,,seasonal,"['Chest discomfort', 'Chills', 'Decreased appetite', 'Diarrhoea', 'Nausea', 'Paranasal sinus hypersecretion', 'Pyrexia']",1,MODERNA,IM 925499,PR,28.0,M,nause and headache,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,WRK,No,No,No,,No,"['Headache', 'Nausea']",2,PFIZER\BIONTECH,IM 925500,MS,61.0,F,"site discomfort first day Day 2 woke with a severe headache, more discomfort at injection site, muscle soreness difficultly lifting arm, fatigue Day 3 same as above not as severe, new symptom joint pain in right shoulder",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,none,none,none,,codeine,"['Arthralgia', 'Fatigue', 'Headache', 'Injected limb mobility decreased', 'Injection site discomfort', 'Myalgia']",1,MODERNA,IM 925501,VT,49.0,F,"7 days after vaccine developed local red, rash at injection site. Rash resolved on its own",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/31/2020,7.0,PVT,"7 days after vaccine developed local red, rash at injection site. Rash resolved on its own",,,,,"['Injection site rash', 'Rash erythematous']",UNK,MODERNA, 925502,TX,46.0,F,"redness, swelling, erythema, and itching at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 925503,NJ,44.0,F,"Headaches, neck spasm with blurred vision at times started 3 days after administration of Moderna COVID-19 Vaccine EUA.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,WRK,None,No,No,,shellfish,"['Headache', 'Muscle spasms', 'Vision blurred']",1,MODERNA,IM 925504,OH,42.0,F,"Extreme weakness, profuse sweating, severe headache, body aches, Temp 102.4, nausea and vomiting, fatique",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,None,,None,,Bactrim DS,"['Asthenia', 'Body temperature increased', 'Electrocardiogram', 'Fatigue', 'Full blood count', 'Headache', 'Hyperhidrosis', 'Metabolic function test', 'Nausea', 'Pain', 'SARS-CoV-2 test', 'Vomiting']",1,PFIZER\BIONTECH,IM 925505,CA,33.0,F,Itchy red warm to the touch hard on the injection site raised up at the injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,UNK,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 925506,FL,49.0,F,Left axillary lymph node swollen and very painful Hard to move left arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Synthroid,None,Hypothyroidism,,None,"['Injected limb mobility decreased', 'Lymph node pain', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 925507,NY,53.0,F,"INJECTION SIDE REDNESS, WIDE SPEARD HIVES, AND ICHYNESS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,amlodopine,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site urticaria']",1,MODERNA,IM 925508,OH,58.0,F,"Moderna COVID-19 Vaccine EUA - 12/31/20 Patient was fatigued and slight headache, arm had bump, hard and very sore. 1/1/21: Patient was hot, sweaty and fever, very tired, arm had bump, hard and sore. 1/2/21: Patient was hot, sweaty and fever off/on, very tired, arm had bump, hard and tender. 1/3/21: Patient had no symptons except arm still had bump, hard and tender. 1/6/21: Patient where shot was given still bump, hard, turned red (like small rash just in that area) and very itchy. 1/7/21: Patient where shot was given still bump, hard, red (like small rash just in that area) and itchy (not as itchy as 1/6/21).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,"Premarin 0.625 (3 x week), Lisinopril 20/12.5 (2 in morning), Bystolic 5 mg (1 at night), multi-vitmain (4 a week).",None,High Blood pressure,Flu Shot - get very mild flu like symptons,"Estropipale (muscle aches), Carvedilol (swelling/muscle aches) and Latax bandaids","['Fatigue', 'Feeling hot', 'Headache', 'Hyperhidrosis', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Pyrexia']",1,MODERNA,SYR 925509,TX,41.0,F,"24-48 hrs site red, swelling, pain, sore arm, severe fatigue, hive to arm and neck of injection site, 48-96 nausea and diarrhea X24hrs, severe migraine, improving fatigue and hives. treated with rest, advil , and Benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,WRK,"singular, Flonase nasal spray, mig relief (vit B12+magnesium), centrum daily women's vitamin, D3, oral progesterone, topical testosterone, Zyrtec, Ambien, glucosamine chondroitin, Nexium",none,"GERD, migraines, seasonal allergies with allergy injections, insomnia",,seasonal allergies,"['Diarrhoea', 'Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site urticaria', 'Migraine', 'Nausea', 'Pain in extremity', 'Urticaria']",1,PFIZER\BIONTECH,IM 925510,WA,40.0,F,"I received the vaccine at 0930 am 1/6, about 6 hours later I started feeling extreme fatigue and a slight sore throat. I left work early at that time. When I got home I couldn't stay awake and fell asleep around 6pm. Then starting having GI distress cramping, pain and diarrhea around 9pm-11pm. At 2 am I woke up with chills and fever, I took a Tylenol around 3-4 m and then broke out if huge sweat, then finally fell asleep. 1/7/21 I mostly have soreness, headache and fatigue now.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,"Multivitamin, Vit D3, Vit C",None,None,,None,"['Abdominal discomfort', 'Chills', 'Diarrhoea', 'Fatigue', 'Gastrointestinal pain', 'Headache', 'Hyperhidrosis', 'Impaired work ability', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'Somnolence']",2,PFIZER\BIONTECH,IM 925511,PA,31.0,F,"Starting roughly 50 hours post vaccine I had site swelling and low grade fever (tmax 100.5), resolved on its own. Then, one week following vaccine return of site induration and itching with itchiness spread to whole arm and shoulder. Induration roughly 3-4 inches. Pain is 4/10, itching 8/10. Arm is warm feeling and some itchiness and warm feeling progressing up left side of face.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/01/2021,4.0,WRK,"Zoloft 200mg, Wellbutrin 150mg, Amlodipine 5mg, one a day vitamins",None,Hypertension,,Penicillin,"['Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Pain', 'Pruritus', 'Pyrexia', 'Skin warm']",1,MODERNA,IM 925512,FL,85.0,M,"Dizzy during observation period immediately after vaccine administration during occupational vaccine drive. Then the patient still decided to go back to work. Upon going back to work was noted to be flushed in the face. And was noted to have high blood pressure. Ultimately was sent to on-site ER for evaluation. Upon questioning, unclear if patient ate or drank prior to administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Unknown,unknown,unknown,,Unknown,"['Dizziness', 'Flushing', 'Hypertension', 'Immediate post-injection reaction']",1,MODERNA,IM 925513,MO,38.0,F,"Just about 15 mins after recieving vaccination, I experienced increased shortness of breath, feeling weak, slight headache, and my heart seemed to race. When I shared this with the pharmasist, she did not offer to take vitals nor seemed concerned. She suggested that I was experiencing anxiety, and that it was not a typical reaction to the vaccine. However, each day since vaccine I have continued to have episodes of shortness of breath. Today, 3 days after the vaccine, I had more shortness of breath than I had since first contracting Covid-19(which was on 10th of Dec). I also was having to stop walking several times every 5 mins or so in order to catch my breath, feeling weakness and fatigue. My sense or taste/smell is gone as well. I was so short of breath today, work was worried anough about me they urged me to go home and call my doctor. I now have a tele-visit set up with my doctor today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,SEN,"Neurotin, Prozac","Tested positive for Covid-19 on 12/10/20 and was symptomatic up to the day of vaccination. I was still expeiencing occasionally shortness of breath but other symptoms had deminished. I told the pharmacist that gave me the vaccination I was still short of breath that morning but said it would be okay to still recieve the vaccine. After the vaccine, my heart was racing and had some increased shortness of breath. I talked to another pharmasist about 20 mins after recieving and shared with her my symptoms. She suggested that it was anxiety and not a side effects from the vaccine. I was hoping they would check my vitals but they did not. Today, I have experienced great increase in short of breath and have had a migraine. The days after recieving vaccine, I had other Covid symproms re-immerge including loss of smell/taste, fatigue, dizziness.",,,"Reglan, Tramadol, Cymbalta, blueberry food allergy","['Ageusia', 'Anosmia', 'Asthenia', 'Dyspnoea', 'Fatigue', 'Headache', 'Palpitations']",1,MODERNA,IM 925514,MO,32.0,F,"I had a COVID vaccine on Dec 28th. My arm hurt a little but nothing bad. I felt like shot was given sub q at the time but didn?t worry about it. It was little red, but as the week has gone by it have gotten red, larger, firm. I have included picture.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/01/2021,4.0,PVT,,,,,,"['Incorrect route of product administration', 'Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Pain in extremity']",1,MODERNA,SC 925516,ND,72.0,F,"client has red area approximately 2-3 inches in diameter over injection site arm. Area is slightly warm and some slight swelling is present. RN, recommended to patient to monitor site closely, use ice and Tylenol/Ibuprofen as needed and consult with primary healthcare provider or other healthcare provider if no improvement.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,PUB,,None,None,,NKA,"['Injection site erythema', 'Skin warm', 'Swelling']",1,MODERNA,SYR 925517,UT,49.0,F,Patient reported numbness and tingling in arm as well as lip tingling after receiving first dose of COVID vaccine. Monitored for 45 min and given 50 mg of Benadryl.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,,,,,sulfa,"['Hypoaesthesia', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 925518,OR,30.0,M,"Headache, muscle and joint aches, and fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,No,No,No,,No,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia']",UNK,MODERNA,IM 925519,NY,68.0,F,Redness and swelling at injection site 8 days post vaccine- took OTC anti-inflammatories,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,PVT,None,None,None,,None,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 925520,IN,49.0,F,"Numbness of mouth,blurry vision for 24 hrs post vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,UNK,None,None,None,,Penicillin,"['Hypoaesthesia oral', 'Vision blurred']",2,PFIZER\BIONTECH,IM 925521,,89.0,F,"Numbness in arm of injection site, x 3 days. Now resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,,['Injection site hypoaesthesia'],1,PFIZER\BIONTECH,IM 925522,AR,44.0,F,"FEVER,BODY ACHES, AND HEADACHE",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925523,VT,64.0,F,"Mild headache, pressure over forehead/eyes. Feeling feverish. Temp 97.6 oral. Generalized aches and pains. Slight dizziness. The next day, all symptoms gone. Injection site/sore arm for 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None,None,GERD Known PVC's. Normal heart,"Many PVC's, almost constant heart palpitations, documented with Holter Monitor (3100 in 24 hours) after flu vaccine in 2011. 55 ",None,"['Discomfort', 'Dizziness', 'Headache', 'Injection site pain', 'Pain']",1,PFIZER\BIONTECH,IM 925524,MO,35.0,F,"Moderate tingling to arms, itching throat, and flushing. Vital Signs 1315 - HR 91, RR 24, SPO2 99% Vital Signs 1320 - BP 125/88, HR 86, RR 20, SPO2 100% Vital Signs 1335 - BP 109/80, HR 84, RR 16, SPO2 98% Vital Signs 1345 - BP 123/90, HR 89, RR 16, SPO2 100%",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Flushing', 'Paraesthesia', 'Throat irritation']",1,MODERNA,IM 925525,TN,88.0,M,10 minutes after vaccine was administered fever and diarrhea started. Extra Strength Tylenol was administered every 4 hours. Over the Counter anti-diarrhea was given. Highest temperature was 102.8. Ibuprofen was given when the fever was highest,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,OTH,Spirono / HTCZ 25/25 Levothyroxin 100 MCG Nifedipine Extended Release 30MG Triamt/HTCZ Cap 37.5 -25 Levetiracetam 500 MG Pot Chloride 10 MEQ ER Sanguenol Nitric Oxide Baby Asprin Omega Q-Plus,none,Nigh Blood Pressure,,none,"['Diarrhoea', 'Pyrexia']",2,MODERNA,IM 925527,VT,66.0,F,BP 132/80 HR 82 RR 18 O2 99% Developed Hives 5-7 minutes after injection. No respiratory distress. Given 50 mg of PO Benadryl and hives lessened. No worsening of symptoms. Has a history of hypersensitivity reactions. Released after 1 hr with strict instructions to self monitor.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,,,,,Has a history of hypersensitivity reactions.,['Urticaria'],UNK,MODERNA, 925528,UT,49.0,F,Patient reported some numbness and tingling in arm as well as lip tingling after receiving first dose of COVID vaccine. Monitored for 45 min and given 50 mg of Benadryl. Patient reported feeling better and was sent home.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,WRK,,,,,Sulfa,"['Hypoaesthesia', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 925529,SC,57.0,M,"After receiving the vaccine within 15 mins I had a metallic taste in my mouth. I exp fatigue and couldn't sleep I went to ER HR 180/10, elevated HR/BP, muscle joint pain and tremendous back pain. After I followed up with my PCP still elevated BP 140/70 as a result I'm on blood pressure medication. I was advised to stay on this new medicine until I receive the second dose of the vaccine. Also was told to take Benadryl and Tylenol before taking 2nd Covid vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/17/2020,0.0,PVT,Estrogen patch,No,No,,"Septra, Sulfur drugs","['Arthralgia', 'Back pain', 'Blood creatinine increased', 'Blood pressure increased', 'Dysgeusia', 'Electrocardiogram', 'Fatigue', 'Fibrin D dimer increased', 'Heart rate increased', 'Insomnia', 'Myalgia']",UNK,PFIZER\BIONTECH, 925530,NY,31.0,M,"About 12 hours after receiving the shot (11:30pm) I experienced fatigue, body aches, and chills. I took 650 APAP and 400mg Advil, drank some water and went to bed. I woke up this morning still feeling slightly achy but no chills and no fatigue. These side effects are common and known based on the VIS provided to me but felt the need to still report it for documentation purposes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Descovy Anastrazole Testosterone cypionate,None,None,,None,"['Chills', 'Fatigue', 'Pain']",1,MODERNA,IM 925531,TX,41.0,F,"Swollen clavicular lymph node, arm soreness, body aches. Taking tylenol and motrin for arm soreness and body aches with improvement.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,,,,Same reaction to first dose of vaccine.,,"['Lymphadenopathy', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 925532,CO,21.0,F,Left arm swelling and itching. Swelling extending to hand.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PUB,None,None,None,,None. though she is now know to be allergic to the Moderna COVID 19 vaccine,"['Peripheral swelling', 'Pruritus']",1,MODERNA,IM 925533,FL,40.0,F,"fist size red area with some burning and itching. On day 6, red area began increasing in size and burning and itching increased significantly",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,"multi-vit, vit D, zinc",none,none,,none,"['Burning sensation', 'Cellulitis', 'Erythema', 'Hypersensitivity', 'Pruritus']",1,MODERNA, 925534,KY,90.0,F,"Raised, red area with warmth and tender to touch. On right deltoid around injection site Kelflex 500mg TID x 7 days and ice packs until redness is resolved Reaction 12/27/2020 Resolved 12/29/2020",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/27/2020,5.0,SEN,KEFLEX; Aricept 10mg Aspirin 81mg Seroquel 25mg Vitamin D 5000 Zinc 50mg Coreg 3.125 Multi-vitamin Namenda 10mg,Covid-19 Positive on 12/1/2020,Alzheimer's Disease Major Depression Disorder Spinal Stenosis Dementia Osteoarthritis,,,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 925535,MO,53.0,F,"Severe hypotension, loss of consciousness, vertigo. Unresponsive. Transported to ED by RN at bedside.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Hypotension', 'Loss of consciousness', 'Vertigo']",1,MODERNA,IM 925536,FL,49.0,F,Swollen and very painful left axillary lymph node. Hard to move the arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Cynthroid,None,Hypothyroidism,,None,"['Limb discomfort', 'Lymph node pain', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 925537,CA,34.0,F,"12/21 VACCINE 11:30. BY 12:30 , TINGLING/NUMBNESS ON L CHEEK BONE. 12/22 I STARTED FEELING MORE NUMBNESS AND PRESSURE ON L CHEEK, TINGLING OF LIPS ON L SIDE, HA ON L SIDE. WENT TO THE ER AROUND 5PM. I TOOK SOME IBUPROFREN, TYLENOL. 12/23 SOMEWHAT RESOLVED FOLLOWING WEEK; SWOLLEN LYMPHNODES ON L SIDE , BACK OF HEAD. COVID TEST; NEGATIVE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,levothyroxine daily; vit D,,thyroid CA 2013,,Penicillan; sulfa,"['Blood test normal', 'Discomfort', 'Headache', 'Hypoaesthesia', 'Lymphadenopathy', 'Paraesthesia', 'Paraesthesia oral', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,SYR 925538,FL,,F,"soreness in arm, fatigue, body aches, headache, pressure behind eyes, blood blister to right arm. runny nose, scratchy throat, racing heart rate",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,WRK,None,None,None,,"Pineapple, Dust. sunscreen","['Blood blister', 'Fatigue', 'Headache', 'Ocular discomfort', 'Pain', 'Pain in extremity', 'Palpitations', 'Respiratory viral panel', 'Rhinorrhoea', 'SARS-CoV-2 test', 'Throat irritation']",1,PFIZER\BIONTECH,IM 925539,UT,46.0,F,About two minutes after vaccination the patient began to experience itchiness and throat tightening. Was administered 50 mg capsules Benadryl PO and continued to have worsening symptoms. A physician on site ordered her sent to the Emergency Department for further treatment and observation. She was given famotidine and prednisone and had significant improvement of her symptoms. She was discharged to home,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Imitrex 100 mg tab PO daily PRN Sertraline 100 mg tab PO daily Wellbutrin SR 150 mg/12 hours extended release tab PO BID,UNKNOWN,"cervical radiculopathy, chronic tension headaches, fatigue, depression, hypertension, major depressive disorder, sleep disorder, snoring, somnolence",,Grass,"['Pruritus', 'Throat tightness']",1,PFIZER\BIONTECH,IM 925540,ND,72.0,F,Patient presented today with red area approximately 2-3 inches in diameter over injection site. Area is slightly warm and slight swelling is present.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,PUB,unknown,none,none,,NKA,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 925541,CA,25.0,F,"tightness in back of throat, itching all over body",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,none,,,NKA,"['Pruritus', 'Throat tightness']",1,MODERNA,IM 925542,NY,30.0,M,"On 1/1/21 (4 days post dose 1), patient developed sudden onset substernal chest pain that resolved and recurred the next day on 1/2/21. Patient was seen in the emergency department. VS were reported WNL, EKG with diffuse ST elevations and subtle PR depressions consistent with pericarditis. ECHO did not show evidence of effusion or tamponade. CXR and basic labs were unremarkable including troponin WNL. Patient sent home with colchicine and NSAIDS with plan for outpatient cardiology follow up. Of note, patient had COVID-19 in April 2020 with documented positive antibodies at that time.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/01/2021,4.0,PVT,,,,,Cefprozil (Hives),"['Chest X-ray normal', 'Chest pain', 'Echocardiogram normal', 'Electrocardiogram PR segment depression', 'Electrocardiogram ST segment elevation', 'Electrocardiogram abnormal', 'Laboratory test normal', 'Pericarditis', 'Troponin normal']",1,PFIZER\BIONTECH,IM 925543,LA,61.0,F,"2 days after receiving 1st vaccine, began with hives and itching to arms face and torso. Also after 24 of receiving 2nd dose began with hives and itching to face hands and arms.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/18/2020,2.0,PVT,Lexapro 20 mg daily Synthroid 75mg daily Aspirin 81 mg daily,None,Depression Hypothyroidism,,None,"['Biopsy', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 925544,WI,47.0,F,"Initial itchiness to injection site just after administration and then itchiness, mild redness and induration for 2 days, then resolution of all issues until 1/6/20 when site became mildly red, indurated and itchy again. This AM awoke with significant redness, induration, pain and itchiness that has increased in size over the past several hours go a softball size and now am also having chills, low grade temp, achiness and nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,Paxil,None,None,,None,"['Chills', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Nausea', 'Pyrexia']",1,MODERNA,IM 925545,IN,42.0,F,"Transient weakness, numbness in bilateral lower extremities and cold left arm. Patient rested and symptoms resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Asthenia', 'Hypoaesthesia', 'Peripheral coldness']",1,PFIZER\BIONTECH,IM 925546,WY,73.0,F,Woke today with swollen itchy red rash at injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,PUB,Unknown,Unknown,None,,None,"['Injection site reaction', 'Injection site swelling', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 925548,MO,54.0,F,"Fever for about 36 hours, headache, sore, red, hot, swollen arm, joint and muscle aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,PVT,,,,,Amoxicillin & Tetnus,"['Arthralgia', 'Erythema', 'Headache', 'Myalgia', 'Pain', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 925549,OK,37.0,F,Just a raised red rash on my arm that the vaccine was given in. It does have some heat to it.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,PVT,"Phentermine, Trulance",none,none,,none,"['Rash', 'Rash erythematous', 'Rash papular', 'Skin warm']",UNK,MODERNA,IM 925550,VT,63.0,F,"1 1/2 weeks after injection developed itching and swelling to site which has progressed to cover most of left upper arm with reddened, swollen area",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/03/2021,10.0,PVT,none,none,none,,"cephalosporins, thimerosol","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA,IM 925551,TX,43.0,F,report soreness at the injection started on 01/06/21 at 5:pm and today she began with achiness and headache with no fever which she states is tolerable at this time. There was no home remedies. continues to work and She will continue to monitor symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Headache', 'Injection site pain', 'Pain']",2,PFIZER\BIONTECH,IM 925552,CT,51.0,F,"Initially post vaccination, patient had redness, swelling and heat at the vaccination site, in addition to head ache. This resolved. On day 9 patient noted, site was itchy, quarter size ""bump"", and redness. Continues to experience headaches. As of 1/7, redness and swelling are gone, continues with headaches and reports intermittent sharp pain to anterior deltoid region. Upon inspection of the area, no redness but small area of selling noted, lower deltoid.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PUB,"Meloxicam, Hydroxychloroquine",,rheumatoid arthritis,,milk - lactose intolerance,"['Headache', 'Injection site erythema', 'Injection site pruritus', 'Vaccination site swelling', 'Vaccination site warmth']",1,MODERNA,IM 925553,TX,41.0,F,"site red, swelling, pain, hives, nausea, diarrhea, severe fatigue, severe migraine, hives to arm and neck side of injection 24-96hrs. Treated with rest, advil, Benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,WRK,"singular, Flonase nasal, Nexium, Zyrtec, oral progesterone, topical testosterone, womens daily centrum, migrelief (b12+magniesium), glucosamine chondroitin, Ambien, vit D3",none,"migraines, GERD, insomnia",,"seasonal allergies, with allergy shots","['Diarrhoea', 'Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site urticaria', 'Migraine', 'Nausea', 'Urticaria']",1,PFIZER\BIONTECH,IM 925554,MO,40.0,F,"Arm became warm, red and swollen. Itchy. Not painful. No fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,01/03/2021,8.0,PVT,,,,,,"['Erythema', 'Peripheral swelling', 'Pruritus', 'Skin warm']",1,MODERNA,IM 925555,,22.0,F,"Extreme arm pain, 102 fever, chills, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Chills', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,MODERNA, 925556,,81.0,M,Expired 1/05/2021,Yes,01/06/2021,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,SEN,,"Acute on chronic heart failure, sepsis","CAD, CKD, DM type 2, CHF, Hx TIA, Atrial fibrillation",,,['Death'],1,PFIZER\BIONTECH, 925557,AZ,38.0,F,Facial numbness on the right side since Saturday 1/2/2020 woke up to half of my face numb the tip of my tongue tingled . and pressure on my right eye and I was not able to focus. I have headaches that come and go. my back is achy since last week and yesterday half of my body felt numb.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,EmergenC packet no other medication,Fever blister on the right side of my lip started 12/16/2020 ended 12/24/2020.,none,,"Penicillin, echinacea, shrimp","['Back pain', 'Headache', 'Hypoaesthesia', 'Ocular discomfort', 'Paraesthesia oral', 'Vision blurred']",1,PFIZER\BIONTECH,SYR 925558,,37.0,M,"After receiving vaccine, pt complains of extreme dizziness, rapid pulse and chest pain that continued to get worse. Rapid response was called for pt assessment. After continued symptoms, pt was brought to ED for further work up",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,"['Chest pain', 'Dizziness', 'Heart rate increased']",1,PFIZER\BIONTECH,IM 925559,CA,50.0,F,"SWELLING,REDNESS,TENDERNESS, ITCHINESS,SORENESS 8 DAYS AFTER VACCINATION.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/06/2021,8.0,OTH,"Vitamin D3, C, K2, Probiotic & Thyroid spplement",,,,Fresh vegetables & Pollen,"['Erythema', 'Pain', 'Pruritus', 'Swelling', 'Tenderness']",1,MODERNA,IM 925560,CA,34.0,F,"small rash on shoulder blade, 2 quarters in size itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,UNK,,,,,,['Rash'],1,MODERNA,SYR 925561,NJ,64.0,F,"Swollen lymph on left under arm, golf ball size induration left arm, area is red and hot, pain in scapula and pins and needles in left arm, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,Na,Na,Na,,Na,"['Arthralgia', 'Erythema', 'Headache', 'Induration', 'Lymphadenopathy', 'Paraesthesia', 'Skin warm']",1,MODERNA,IM 925562,AR,59.0,F,Tested positive for COVID 19 on 1/5/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PVT,"Nifedipine, furosemide,levothyroxin, k+,mult- bit, fish oil",,"Hypertension, diabetes, bell?s parley",,Sulfur,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,SYR 925563,IN,60.0,F,"restlessness throughout body same night, next morning woke up with body aches, nausea, pain in joint/muscles, shaking , headache, fever 100. Took Tylenol arthritis",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,,,hypertension,,"codeine, Lisinopril","['Arthralgia', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Restlessness', 'Tremor']",1,MODERNA,IM 925564,IL,53.0,F,"arm pain, runny nose, extreme fatigue, fever highest 101.5 .symptoms resolved after 2 days. took over the counter analgesic",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PUB,"Lisinopril, Lantus Insulin. Humalog insulin, Synthroid, Lexapro, Synthroid, Protonix, Xanax, Multivitamin, Potassium",none,"Diabetes Type 1, Hypertension, Hypothyroidism, Hypokalemia",,none,"['Fatigue', 'Pain in extremity', 'Pyrexia', 'Rhinorrhoea']",1,MODERNA,IM 925565,NY,34.0,F,Reported Chills and fever of 103F. Symptoms resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Chills', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925566,OR,47.0,F,"Headache for 3 days so far. Swelling of lower extremities, joint pain, difficult to concentrate/decision making.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,"Levothyroxine, liothyronine, oral contraceptive, l-tyrosine, citicoline",none,none,,"Amoxicillin, penicillin, sulfa meds, zoloft, wellbutrin Allergic to unidentified preservatives in foods","['Arthralgia', 'Disturbance in attention', 'Headache', 'Peripheral swelling']",1,MODERNA,IM 925567,WI,30.0,M,"Malaise, fatigue, headache, muscle aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Fatigue', 'Headache', 'Malaise', 'Myalgia']",UNK,MODERNA, 925569,FL,26.0,F,"The day after I got the vaccine, I had extreme headache, sore arm, and fever of 38.5 degree Celsius. I decided to take cold-warm shower, and Metamizole 1mg. The fever went down a couple of hours after. I continued with the medication the next day for the headache. At night of the next day, I had nausea. Three days after the shot, I have not taken any more medications, no more fever, sore arm, nor nausea, but still have a mild headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,SCH,,,,,,"['Headache', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 925570,IN,38.0,F,Swelling around the throat including tonsils & lymph nodes within 5 minutes of vaccine administration.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Birth control, Zyrtec, Elderberry, Zinc, vitamin D",None,None,,,"['Lymphadenopathy', 'Pharyngeal swelling', 'Tonsillar hypertrophy']",1,PFIZER\BIONTECH,IM 925571,NY,61.0,F,"Immediately after receiving the vaccine, patient developed sensation of throat numbness in the back of the throat. Patient denied SOB, wheezing, throat swelling, stridor, rash, chest pain, tongue swelling. One dose of diphenhydramine 25 mg PO suspension and referred to the Mount Sinai emergency department. Sensation resolved after a total of 30 minutes (10 minutes after receiving diphenhydramine). Vital signs and physical exam were WNL with the exception bilateral submandibular adenopathy. Patient was observed in the ED for approximately one hour with no clinical change and was subsequently discharged home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,None reported,None reported,,No known drug allergies,"['Immediate post-injection reaction', 'Lymphadenopathy', 'Pharyngeal hypoaesthesia']",1,PFIZER\BIONTECH,IM 925572,MO,51.0,F,"Right arm, warm, firm pink, itchy and burning feeling and tired, went to employee Health on 1/7/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/06/2021,6.0,PVT,,,,,,"['Burning sensation', 'Erythema', 'Fatigue', 'Induration', 'Pruritus', 'Skin warm']",1,MODERNA,IM 925573,MD,51.0,F,"Reports that several hours after receiving the vaccine, she noticed her lower lip was tingling and felt full. Over the next 24-48 hours she developed painful oral lesions on the inner and outer surface of her lower lip. These were fixed lesions; some eroded and crusted over. Presented to primary care clinic on 31DEC2020 and was diagnosed with HSV. She was prescribed a course of PO valacyclovir and topical acyclovir ointment. All lesions are now fully resolved; however, she reports resulting tingling sensation. Reports she was feeling well on 12/28 and in the days leading up to the vaccine. No known sick contacts. Denies any previous history of HSV lesions. Reports history of acute Varicella infection in her early 20's. Suspect this was a reactivation of HSV or VZV triggered by vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Allegra 180mg daily Flonase 2 sp/n daily Patanol eyedrops prn Losartan HCTZ Metoprolol Estradiol Hypromellose opt gtt mineral oil/petrolatum opt carboxymethylcellulose gtts Fioricet Biotin OTC Colon cleanse po daily Alka-seltzer PRN Diclof,None reported,"Rhinitis, GERD, HTN, Osteoarthritis",,Pineapple and kiwi cause oral irritation. Phenergan causes nightmares.,"['Herpes simplex', 'Herpes virus test', 'Lip erosion', 'Lip pain', 'Oral discomfort', 'Oral disorder', 'Paraesthesia oral', 'Scab', 'Varicella zoster virus infection']",1,MODERNA,IM 925574,VA,48.0,F,"Pt reported right sided facial swelling (no numbness or tingling) after admin of 2nd COVID19 vaccine. Pt had been diagnosed with COVID19 on 12/27 between both vaccines. SHe denied any numbness, tingling, weakness, tongue swelling, lip swelling, dysphagia, wheezing or shortness of breath. no eyelid swelling. no rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Mucinex DM,COVID19 disease (diagnosed 12/27/2020),None,,NKDA,['Swelling face'],2,PFIZER\BIONTECH, 925575,GA,52.0,F,"redness at vaccine site, feverish, swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,PHM,ozempic,none,none,,none,"['Injection site erythema', 'Pyrexia', 'Swelling']",UNK,MODERNA, 925576,TX,47.0,F,"redness, itching, swelling at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 925577,CO,81.0,F,Arm appears red and swollen at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,PVT,.numerous,None,Heart pacemaker/defibralator,,None,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,SYR 925578,VA,62.0,F,Soreness and redness at injection site - very red 1/5/21 with low grade fever. Better today - not as red.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,Polia every 6 months for osteo,None,Osteo,,None,"['Injection site erythema', 'Injection site pain', 'Pyrexia']",1,MODERNA,IM 925579,PA,36.0,F,"Dizziness, flushing,nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Dizziness', 'Flushing', 'Nausea']",1,MODERNA,IM 925580,MO,32.0,F,"Employee here with COVID vaccine reaction that started the day after her injection in left upper arm deltoid area. The initial reaction was a red area that did seem to go away then became itchy and redness spread. Area is red, swollen itching and warm to the touch. Measures 9 X 9.5cm and outlined in ink for monitoring. Explained conservative measures including cool compresses, and is allowed by PCP OTC IBU, and antihistamines. If the area worsens becomes taught or streaks develop advised to seek further care with PCP or walk in clinic. Employee verbalized understanding and agrees with plan.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/29/2020,1.0,PVT,,,,,PPD,"['Injection site erythema', 'Injection site pruritus', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,IM 925581,,26.0,F,fever 101.4 and muscle aches and elevated heart rate all responded to acetaminophen,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,UNK,,,,,,"['Heart rate increased', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 925582,NY,52.0,F,"Reported difficulty breathing, rash at injection site, throat closing. Used Epi pen ( history of allergies). Transferred to ED",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Dyspnoea', 'Injection site rash', 'Throat tightness']",1,PFIZER\BIONTECH,IM 925583,,36.0,F,transient right sided facial droop lasting 2-3 seconds 4 days after COVID-19 shot #1 of 2,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/21/2020,4.0,MIL,hydroxyzine and flexeril,,,,allergy to MSO4 (nausea / vomiting),['Facial paralysis'],1,PFIZER\BIONTECH,IM 925584,,38.0,F,"Swelling of hands, throat, and cheeks. Itching/tingling back of tongue. Resolved after 45 minutes. Took Benadryl 50 mg.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,Wellbutrin 150 mg xl daily,,Raynaud's,,"penicillin- hives, nickel","['Paraesthesia oral', 'Peripheral swelling', 'Pharyngeal swelling', 'Swelling face', 'Tongue pruritus']",1,PFIZER\BIONTECH,SYR 925585,,52.0,M,"Fever, Chills, Sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,unknown,unknown,unknown,,unknown,"['Feeling cold', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 925586,NY,42.0,M,"Scaled 0-10 Pain at the injection site (6): Can not raise left arm higher than shoulder level Fatigue (8) New or worsened muscle pain (8) New or worsened joint pain (8) Nausea (9): took zofran Vomiting (8) Fever (7): 101F: took tylenol 650 mg Q3 hours since 23:00 on 1/6/2021, 3:00, 6:00, 8:00, 11:00 Chills (8) Other: Burning on urination, eyes burning, left side face tingling,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Arthralgia', 'Chills', 'Dysuria', 'Eye irritation', 'Fatigue', 'Injected limb mobility decreased', 'Injection site pain', 'Myalgia', 'Nausea', 'Paraesthesia', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 925587,MO,38.0,F,"Symptoms of Covid seemed to reimmerge right after recieving the vaccine including signifant, shortness of breath, weakness, fatigue, loss of taste/smell, nausea, and migraine headaches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,SEN,None,"Tested and diagnosed Covid positive on 12/10/20. Symptoms started a day before tested. I have had shortness of breath lingering but it had improved and was sent back to work. I continued to have minor fatigue and occasionally shortness of breath. About 10 mins after recieving the vaccine on 1/4, I started to feel some heart palpatation, increased shortness of breath and some weakeness. I spoke to a pharmacist that was giving the vaccines and she was not concerned about my symptoms and suggested it was anxiety. I also told her I wasnt feelimg myself. Today, 3 days after reciving vaccine, I have had several episodes where I had to stop walking, take a break and catch my breath. I have had a migraine for 3 days and feel very fatigued. Also loss of taste and smell is gone again. I am feeling like I felt when I first got Covid.",N/a,,"Reglan, Cymbalta, Tramadol, blueberries","['Ageusia', 'Anosmia', 'Asthenia', 'Condition aggravated', 'Dyspnoea', 'Fatigue', 'Migraine', 'Nausea']",1,MODERNA,IM 925588,CO,33.0,F,"Localized reaction near injection site 5 days post vaccination. Red/defined/raised/itchy. Improved on day 6, still some itching which pt took antihistamines for.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/28/2020,5.0,PVT,"acyclovir, sertraline",,,,pineapple which pt admits to eating a little of the day before,"['Erythema', 'Injection site reaction', 'Local reaction', 'Pruritus', 'Swelling']",1,MODERNA,IM 925589,AK,62.0,F,"Approximately 25-30 minutes after administration of vaccine, patient complained of a soreness of her right throat and felt a sensation of swelling. Clinical exam revealed a small area of erythema on right side of posterior pharynx. No edema was noted. No skin rash or changes. No soft tissue and no facial/throat swelling. Lungs were CTA bilaterally. VS remained stable. Treated with Benadryl 25mg capsule PO x1. Symptoms resolved within 20 minutes. Patient remained in observation for an additional hour. Discharged home in stable condition, symptoms completely resolved. Given PO Benadryl to take home use prn.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,Onglyza 5mg Metformin ER 500mg Losartan 50mg/HCTZ 12.5mg Jardiance 25mg Gabapentin 300mg Fluticasone 250mcg/salmeterol 50mcg INH Albuterol INH Epipen 0.3mg/0.3mL autoinjector,No known illness.,Diabetes Hypertension Asthma Obesity,influenza reaction of unknown significance and timeframe/details unknown. Patient has received this vaccine since and did well. ,"Anaphylaxis to Tylenol Sinus Severe Congestion Daytime formula Hives to Iodine, Aleve, Nexporium Multiple seasonal allergies. H/o severe reaction to an epidural, specific unknown. H/o mild reaction to influenza vaccine but has had since without problem.","['Oropharyngeal pain', 'Pharyngeal erythema', 'Pharyngeal swelling']",1,MODERNA,IM 925590,NC,50.0,F,"The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pfizer EK5730) receipt 16 DEC 2020. She reports no immediate reaction except experienced a dry throat which she noted after her 30 minute wait, but no urticaria, SOB, wheezing, oral/face/throat/tongue edema, flushing, pruritic, CP n/v/d. She states about 3 hours later she developed a dermatitis initially to her legs. The lesions were raised, pink, initially nonpruritic, fixed but no vesicles, pustules or bruising. She took a shower which exacerbated the symptoms with erythematous patches and severe burning sensation. She reports she was seen in ER and her spouse noted lesions to her neck and ears. Her eyes felt swollen. She left ER due to the wait and obtained Benadryl OTC. She saw her PCP in the morning. She received IM dexamethasone and oral prednisone dose pack. She continued to not feel well. She experienced heart palpitations, feeling hot and flushed, fatigue and headache which she treated with Tylenol. She treated the dermatitis with Zyrtec 10-20 mgs q1-2 x daily, but sometimes took Benadryl. Last dose was Benadryl at midnight, Zyrtec 10 at 0600 and has one day of prednisone left. She also experienced bilat tingling in her feet starting day 5. which the left resolved but her right foot continued. She has no paresis, paralysis, altered gait, tripping or fall, difficulty emptying her bladder. She saw PCP on 05 January. ESR was normal . Overall symptoms improved but continued r foot numbness, pain to her legs. She reports PCP ordered CXR and abdominal series which were normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/16/2020,0.0,MIL,,,Idiopathic urticaria,,,"['Abdominal X-ray', 'Chest X-ray normal', 'Dermatitis', 'Dry throat', 'Erythema', 'Eye swelling', 'Fatigue', 'Feeling hot', 'Flushing', 'Headache', 'Hypoaesthesia', 'Malaise', 'Pain in extremity', 'Palpitations', 'Paraesthesia', 'Skin burning sensation', 'Skin lesion', 'Skin swelling']",1,PFIZER\BIONTECH,IM 925591,OH,50.0,F,Patient woke up on 1/7/2021 (8 days after vaccination) with a large red dot at the injection site. The area itches.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,"Zoloft, Synthroid, lisinopril, omeprazole, Zocor, elderberry, zinc, Vitamin C, Vitamin D3",None,"Hypothyroidism, hypertension, high cholesterol, depression, GERD",,"Milk, Keflex","['Injection site erythema', 'Pruritus']",1,MODERNA,IM 925592,KY,66.0,F,"At 8:30 pm , sudden increase in Blood pressure 192/90 , pulse rate at 108 Palpitation Lasted for 30-45 min then gradual decline to normal at 130/80 Laid in bed & drinking water",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Lipitor 10 mg once a day Multivitamin Vit C 500 mg once a day,None,None,,Epinephrin for dental work,['Blood pressure increased'],UNK,MODERNA,IM 925593,GA,45.0,M,"I am an anesthesiologist reporting my own event: injection received 0900. At 1400 I began low grade fever and not feeling well. By 1600 I had extreme fatigue and severe mental fogginess. This fogginess lasted approximately 24 hours. Other reactions included chills, fever, myalgia, arthralgia, headache as expected. I feel the mental effects could put patients in danger if healthcare practitioners are not aware of the possibility of this and receive the vaccine while on duty. I did not experience this with the first dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Advair, albuterol, omeprazole, singulair",none,asthma,,NKDA,"['Arthralgia', 'Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Malaise', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925594,NY,56.0,F,"Reports Itchy throat, difficulty breathing. Has a history of multiple allergies. Transferred to ED. Symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Dyspnoea', 'Throat irritation']",1,PFIZER\BIONTECH,IM 925595,MO,32.0,F,"I had a COVID vaccine on Dec 28th. My arm hurt a little but nothing bad. I felt like shot was given sub q at the time but didn?t worry about it. It was little red, but as the week has gone by it have gotten red, larger, firm.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/01/2021,4.0,PVT,,,,,,"['Erythema', 'Incorrect route of product administration', 'Induration', 'Pain in extremity']",1,MODERNA,SC 925596,NJ,32.0,F,Soreness in arms and nausea.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"Aurovela 24 FE, Valacyclovir",None,None,,None,"['Nausea', 'Pain in extremity']",1,MODERNA, 925597,ND,31.0,F,"Muscle aches, headache, nausea, 1 episode of passing out",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,SEN,Multivitamin,,,,,"['Headache', 'Loss of consciousness', 'Myalgia', 'Nausea']",1,MODERNA, 925598,UT,44.0,F,"Patient has history of anaphaylyxsis, she pre medicated at home this morning with Zyrtec 20 mg and Famotadine 40 mg prior to going to F13 clinic for her covid vaccination. Patient stayed an hour after vaccine administration to be monitored. She came to ER for further monitoring and allergic reaction concerns and received 2 doses of 25 mg diphenhydramine. She was reporting itching of her trunk and arms, itchy throat, and hot flashes. She was monitored in ER, she maintained airway and stayed on RA the entire visit.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,WRK,,,,,Morphine,"['Hot flush', 'Pruritus', 'Throat irritation']",1,PFIZER\BIONTECH,IM 925599,NJ,39.0,M,Pt felt fine until 24 hrs later when he experienced chills lasting though the night and now he has severe headache.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Cinthroid,no,no,,no,"['Chills', 'Headache']",2,PFIZER\BIONTECH,IM 925600,PA,53.0,F,"- approximately 1 hour after receiving the vaccination, the injection site was hard, swollen, red circle approximately size of a half dollar, and sore to touch. now, 48 hours after ae currently on going. - later in the evening, same date of vaccination, I felt itchy all over, itchiness resolved approximately 3 hours after itching began.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Synthroid 50mg,none,none,,Chlorhexidine,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Pruritus']",1,MODERNA,IM 925601,OH,61.0,F,"Day 2 diahrea and vomited for 1 hr. (thought food poisoning) on day 8 right arm swelled up size approximately 2"" x 3"". On day 9, 2/3 of right arm swollen, firm and warm to touch. Showed 2 physicians, advised to apply topical benadryl and oral benadryl taken.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/31/2020,2.0,PVT,"multi vitamin, Vit D3, VitC, zinc",none,none,,sulfa,"['Diarrhoea', 'Induration', 'Peripheral swelling', 'Skin warm', 'Vomiting']",1,MODERNA,IM 925602,MS,24.0,M,"Chills, fever, aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,,,,,,"['Chills', 'Pain', 'Pyrexia']",1,MODERNA,IM 925603,MI,29.0,F,"Pt received vaccine on 12/29/2020. On 01/05/2021, she noted large, approximately 11cm, red, swollen, warm and painful area at the site of the injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,None,None,None,,Augmentin,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 925604,WI,30.0,F,Shortly after receiving the vaccine: lightheadedness lasting a few hours. The day after sore arm at the injection site. 3 days after until present: major fatigue.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Norethindrone birth control,,,,"Biaxin- rash, flagyl-rash","['Dizziness', 'Fatigue', 'Injection site pain']",1,PFIZER\BIONTECH,IM 925605,MO,35.0,F,"Moderate tingling to arms, itching throat, and flushing. Vital Signs 1315 - HR 91, RR 24, SPO2 99% Vital Signs 1320 - BP 125/88, HR 86, RR 20, SPO2 100% Vital Signs 1335 - BP 109/80, HR 84, RR 16, SPO2 98% Vital Signs 1345 - BP 123/90, HR 89, RR 16, SPO2 100%",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Flushing', 'Paraesthesia', 'Throat irritation']",1,MODERNA,IM 925606,MT,53.0,F,"Cellulitis - redness, swelling, painful lump at injection site aprox 4 inch diameter",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/07/2021,9.0,OTH,None,,,,Latex,"['Injection site cellulitis', 'Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site swelling']",1,MODERNA,SYR 925607,NV,50.0,F,Injection site redness or pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,"Levothyroxine, Progesterone, Aleve, Culturelle",none,hypothyroidism,,Benzoperoxide,"['Injection site erythema', 'Injection site pain']",1,MODERNA,IM 925626,IL,,U,"herpes zoster; post herpetic neuralgia; vision problems; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided. On or about 07-FEB-2017, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to the patient vaccination, the patient presented herpes zoster, post herpetic neuralgia and vision problems. As a direct and proximate result, the patient had been treated by a medical provided. Additionally, the symptoms had been resulted in physical limitation not present prior vaccination. The patient sustained severe and permanent injuries; the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. As a direct and proximate result, the patient suffered severe and permanent physical injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reporter considered the event of herpes zoster, post herpetic neuralgia and vision problems to be related to zoster vaccine live (ZOSTAVAX).",Not Reported,,Not Reported,Not Reported,,Yes,N,02/07/2017,,,UNK,,,,,,"['Herpes zoster', 'Post herpetic neuralgia', 'Visual impairment']",UNK,MERCK & CO. INC., 925627,AK,,U,"outbreaks of herpes zoster; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided. On an unspecified date, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to the patient vaccination, the patient presented multiple outbreaks of herpes zoster. As a direct and proximate result, the patient had been treated by a medical provided. Additionally, the symptoms had been resulted in physical limitation not presented prior vaccination. The patient sustained severe and permanent injuries; the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. As a direct and proximate result, the patient suffered severe and permanent physical injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reporter considered the event multiple outbreaks of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).",Not Reported,,Not Reported,Not Reported,,Yes,N,,,,UNK,,,,,,['Herpes zoster'],UNK,MERCK & CO. INC., 925632,WI,61.0,F,"worry; frustration; regrets/wishing she would have never taken it; phlegm; can't talk; taking her voice, she felt like she was losing her voice; scary/""scaring"" her; coughing/cough; difficult for her to catch her breath/lost her breath, couldn't catch her breath/couldn't breath; allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date 30Apr2021) intramuscular on 29Dec2020 09:16 at 0.3 mL, single for Covid-19 immunization in a hospital. Medical history included diabetic, allergy reactions, blood pressure (abnormal), cholesterol (abnormal); all ongoing, and reaction to dust. Concomitant medications included ongoing amlodipine;hydrochlorothiazide;valsartan for blood pressure, ongoing potassium for unspecified indication, BP pills (unspecified) and has cholesterol medications. The patient informed that yesterday (29Dec2020), she got the COVID vaccine shot at work, received it at 9:16 am and was monitored for 30 minutes post administration. The patient went to work and was holding the babies. The patient worked in transport in the NICU at a hospital. Few hours after the injection, while working in the NICU, she experienced coughing to the point where it was difficult for her to catch her breath. The patient started coughing so bad, she had no control. She mentioned trying to drink water and continued coughing more. The patient lost her breath, couldn't catch her breath, she had to call for the charge nurse (manager), as she couldn't breath and they took her to the ER and consulted at the ER of her facility. The patient informed that she kept coughing and couldn't catch her breath. They made her drink water. The patient has allergies, so she always has an epi pen with her. The patient felt like she had an allergic reaction to the vaccine. The doctor there explained that her symptoms were not related the Covid-19 vaccine she received earlier. The patient specified that the last time she had a similar reaction was at work and was due to dust. The patient explained that she was perfectly fine before receiving the vaccine, laughing, and so what can her symptoms be related to, if it was not the vaccine. The patient was coughing all night, can't get rid of the cough. She has called her doctor. The nurse said just to watch herself for now. The patient informed that she was supposed to go back to work tomorrow and she was afraid to go around the babies. The patient informed that today (30Dec2020), she gargled apple cider vinegar and salt water, and phlegm came out. The patient continued saying that she has still been coughing, can't talk and that it was scary. The patient informed that she was taking her voice, she felt like she was losing her voice. It was ""scaring"" her. She was unsure if it was the Pfizer vaccine. The patient attempted to reach her HCP and that she cannot be seeing at her clinic due to her cough. The patient mentioned that she won't have access to a respiratory clinic until Tuesday. The patient expressed her concerned about returning to work with babies and asked if she should return to work tomorrow. The patient pursued verbalizing her worry and frustration. The patient asked if she can decide not to get the second dose. The patient voiced her regrets on receiving the first dose of the COVID-19 vaccine. She stated wishing she would have never taken it and that all who have an EpiPen should not receive it. The outcome of the event cough was not recovered, Dyspnoea, Allergy to vaccine, Productive cough, Speech disorder, Aphonia, Nervousness, Anxiety, Frustration tolerance, Depressed mood was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,;,Allergic reaction (carries epi pen at all times); Blood cholesterol abnormal; Blood pressure abnormal; Diabetic (10 to 13 years),Medical History/Concurrent Conditions: Dust allergy,,,"['Anxiety', 'Aphonia', 'Cough', 'Dyspnoea', 'Fear', 'Frustration tolerance decreased', 'Productive cough']",1,PFIZER\BIONTECH,OT 925633,TN,54.0,F,"her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her left side, a cold spike feeling up her shoulder and neck and up to her face; upper esophageal sphincter got tight and felt funny like she was going to throw up; her whole body was shaking- her head, hands, and legs; feeling giddy; blood pressure was up; being stressed; was going to throw up/transient nausea; felt a little funny; This is a spontaneous report from a contactable Nurse(patient). A 54-year-old female patient received BNT162B2 (lot number EL0140), via an unspecified route of administration at left deltoid on 30Dec2020 14:28 at the 54 years old at 0.3 mL single for where she works she was exposed to patients who need rehab that were exposed and getting COVID. The patient medical history included Primary Essential Tremors and ongoing (had these for about 10-11 years. Her mother and grandmother also had them. Normally they were very fine, small tremors that people didn't notice. She can hold and turn her head and hide it) and Sulfa drug allergy (would get shortness of breath). The concomitant product was none. The patient previously took flu vaccine and experienced preservative made neck twitch and joint sores. Yesterday the patient got the COVID Vaccine and had a pretty significant adverse event. She was calling to report it and to see if she should get the second dose of the vaccine. The patient was also a licensed speech pathologist. She received the vaccine yesterday at 2:28 PM. She was allergic to Sulfa drugs and would get shortness of breath, so they wanted her to wait 30 minutes for monitoring. She was feeling giddy on 30Dec2020, but she ran into a friend that she had not seen before quarantine, so they were talking. It was exciting. After her 30 minutes she went to her car and felt a little funny. She thought she was hungry so she ate half a banana and had some water. She had an appointment to get to so she started to drive off, and by the time she got to the interstate she was feeling funny. She got on her left side, a cold spike feeling up her shoulder and neck and up to her face on 30Dec2020. This was like the precursor. Then on 30Dec2020 her face started to go numb. It felt like a dental block you would get with Lidocaine. It went from her temple area, below her eye all the way to her lips. It was midline on the left side. She was breathing fine. She was trying to figure out if she should pull over or call(Number), but her airway did not close up. Her upper esophageal sphincter got tight and felt funny like she was going to throw up. She drove to the hospital close to her house which is affiliated with where she got the vaccine. She normally had primary tremors, small to where people do not notice. But her whole body was shaking- her head, hands, and legs on 30Dec2020. She looked like a bobble head. But she could still breath. They took her right in and they did an EKG to make sure it was not her heart. Her blood pressure was up on 30Dec2020, she assumes for being stressed. They monitored her. They gave her Pepcid and Benadryl. She did not want any nausea medications. She stayed for about 2 hours and slept some from the Benadryl. Her face slowly became less numb. The numbness went away started from her lips and outward to her check and temple area. Then it just felt funny. When she touched it, which she never lost sensation, it was like, whose face is this? It was strange. She is not numb anymore. It took a while for it to go away, and it still felt weird. When she woke up this morning it was completely gone. She had recovered completely from all of these things. The only thing she has now was some transient nausea. It was very mild. It comes and goes. It had improved. She had not taken anything for it. The events Feeling funny, her face started to go numb, upper esophageal sphincter got tight, a cold spike feeling up her shoulder and neck and up to her face, Her whole body was shaking- her head, hands, and legs, were all assessed as Medically significant. The outcome of the event Nausea was recovering, the events Felt giddy, blood pressure was up, Stress was recovered on 31Dec2020, the other events were recovered on 30Dec2020. The reporter considered there was a reasonable possibility that the events Feeling funny, a cold spike feeling up her shoulder and neck and up to her face, Face started to go numb from her temple area, below her eye all the way to her lips, upper esophageal sphincter got tight , whole body was shaking- her head, hands, and legs, Nausea, were related to the product BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,,Essential tremor (had these for about 10-11 years),Medical History/Concurrent Conditions: Sulfonamide allergy (get shortness of breath),,,"['Blood pressure increased', 'Dizziness', 'Electrocardiogram', 'Feeling abnormal', 'Feeling cold', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Nausea', 'Oesophageal disorder', 'Stress', 'Tremor']",UNK,PFIZER\BIONTECH, 925634,,,U,"DVT; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The nurse asked if there is any DVT cases reported following the administration of Pfizer-BioNTech COVID-19 Vaccine. E-transmitting duplicate AE caller already reported a DVT case post vaccination. Caller also asked ""Why is there's a statement indicating that individuals with a history of bleeding disorder or taking anti-coagulant should contact their vaccination provider? How did they prove 95 % efficacy? Why aren't antibodies produced after the 1st dose of Covid-19 vaccine?"" The outcome of the event DVT was unknown. Information on Lot/batch number has been requested.; Sender's Comments: Very limited information was provided for this individual patient, such as pre-existing medical history, suspect administration details, clinical course and relevant supportive lab data for the reported Deep vein thrombosis (DVT). Pending further details, the Company would handle this reported DVT related to the administration of BNT162B2, COVID-19 immunization, for reporting purpose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Deep vein thrombosis'],UNK,PFIZER\BIONTECH, 925635,PA,49.0,F,"throat swelling; Initially had headache; dizziness; irritability; Throat tingling; difficulty swallowing; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EJ1685) as the first dose via an unspecified route of administration in the left arm on 29Dec2020 06:00 for COVID-19 immunization. Medical history included fibromyalgia, asthma, prediabetes, and carpal tunnel syndrome. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no previous allergies to vaccines. The patient allergies to medications which included: doxycycline, medroxyprogesterone acetate (DEPO-PROVERA), metoclopramide (REGLAN), gluten. The patient initially had headache, dizziness and irritability, throat tingling, throat swelling, and difficulty swallowing started around 12 hours after injection, event onset date reported as 29Dec2020 18:00. The events resulted in emergency room/ department or urgent care. The events were reported as non-serious by HCP. Treatment received for the events included diphenhydramine and hydroxyzine embonate (HYDROXYZINE PAMOATE). The outcome of the events was recovering.; Sender's Comments: The reported pharyngeal swelling together with other symptoms was likely related to the single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Asthma; Carpal tunnel syndrome; Fibromyalgia; Prediabetes,,,"['Dizziness', 'Dysphagia', 'Headache', 'Irritability', 'Pharyngeal paraesthesia', 'Pharyngeal swelling']",1,PFIZER\BIONTECH, 925636,MI,37.0,F,"Moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection; Moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection; This is a spontaneous report from a contactable physician (patient). A 37-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 17:15 at single dose on her left arm for covid-19 immunization. Medical history included known allergies to penicillin. The patient had no other medical history. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient was not received list of any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection on 23Dec2020. These events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient had received prednisone to treat the events. The outcome of the events was not recovered.; Sender's Comments: A possible contribution role of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of sensorineural hearing loss in left ear and headache cannot be excluded due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/22/2020,12/23/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Deafness neurosensory', 'Headache']",1,PFIZER\BIONTECH, 925637,CA,46.0,F,"jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around her mouth went numb; heart palpitations; I had hives on my chest; a wave of heat rush up her back; This is a spontaneous report from a contactable nurse (patient). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in left arm on 22Dec2020 10:30 at first single dose for COVID-19 immunization. Medical history included ectopic pregnancy, hay fever. Concomitant medication received within 2 weeks included: loratadine, colecalciferol (vitamin D), olly womens multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. About 15 minutes after the vaccine the patient experienced jaw tightening and muscle spasms. The patient was given oral Benadryl 50 mg. About 5 minutes after taking the Benadryl, her entire face and around her mouth went numb. The patient began having heart palpitations and felt a wave of heat rush up her back. She had hives on her chest. The patient received 1 dose of epinephrine from an Epi-Pen and transported to the emergency room for further treatment. Adverse event start date: 22Dec2020 11:00 AM. Events were considered as non-serious. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event included: Benadryl, Epinephrine, Solumedrol, Pepcid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Test Name: SARS-CoV-2 by PCR (Nasal Swab) on 30Dec2020: Negative. Outcome of the events was not recovered.; Sender's Comments: The temporal relationship is suggestive of an acute anaphylactic reaction. Based on the temporal relationship and the known pattern of response, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,PVT,; VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: Ectopic pregnancy; Hay fever,,,"['Feeling hot', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Muscle spasms', 'Muscle tightness', 'Palpitations', 'SARS-CoV-2 test negative', 'Urticaria']",1,PFIZER\BIONTECH, 925638,,29.0,F,"Joint pain; loss of balance; increased drowsiness; Headaches induced by allergies; Limited neck mobility/lessened neck pain but still limited mobility; Scalp tenderness and sensitivity; Significant migraines/debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness); Sharp pains in neck/Neck pain; Sharp pains in neck, ear, head pain (similar to an ear infection pain); head pain/sharp pains in lower head/covers whole head, pulsating, sharp pain/Increase in headaches but no longer centralized to back of head/ headaches induced by allergies; Nausea; Neck stiffness; This is a spontaneous report from a contactable Other Health Professional (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection, lot number was unknown, via an unspecified route of administration in the right arm on 22Dec2020 07:30 at a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient was not pregnant. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received vaccine in Tuesday (22Dec2020). The following Sunday (27Dec2020) at 12:00, she had nausea and neck stiffness. On Monday (28Dec2020), she had sharp pains in neck, ear, head pain (similar to an ear infection pain), and nausea. She used teledmed appt and got antibiotics (unspecified). On Tuesday (29Dec2020), she had significant migraines, limited neck mobility, sharp pains in neck and lower head, scalp tenderness and sensitivity which felt like whiplash when she moved her head w/ her head feeling ""swimmy"". She tried to see urgent care but was to go to ER. On Wednesday (30Dec2020), there was lessened neck pain but still limited mobility, increased in headaches but no longer centralized to back of head. She went to ER and they said that she had headaches induced by allergies. She mentioned that she never had migraines or allergies in her life. They also reported no ear infection. She did complete CT Scan with no concerning results on 30Dec2020. On Thursday (31Dec2020) & Friday, she no longer has neck pain but with continued nausea, joint pain, debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness). The events were reported as non-serious. The treatment received for the adverse events included fluids, pain & nausea meds. The patient was not diagnosed with Covid prior to vaccination. She was tested for covid post vaccination on 30Dec2020 through a nasal swab with negative result. The outcome of the events neck stiffness, ear pain, scalp tenderness and sensitivity, and 'Headaches induced by allergies' was unknown; while neck pain was recovered on 31Dec2020. The outcome of the events 'significant migraines/debilitating migraines', nausea, limited neck mobility, head pain/Headache, joint pain, loss of balance, and increased drowsiness was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the event migraine cannot be excluded based on a compatible temporal relation between vaccination and onset of event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/27/2020,5.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Balance disorder', 'Computerised tomogram normal', 'Dizziness', 'Ear pain', 'Headache', 'Hyperacusis', 'Migraine', 'Mobility decreased', 'Musculoskeletal stiffness', 'Nausea', 'Neck pain', 'Pain', 'Pain of skin', 'Photophobia', 'SARS-CoV-2 test negative', 'Sensitive skin', 'Somnolence']",1,PFIZER\BIONTECH, 925639,ID,34.0,F,"Miscarriage; patient was pregnant while taking BNT162B2; patient was pregnant while taking BNT162B2; This is a spontaneous report from a contactable Other Health Professional. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly on 22Dec2020 06:00 AM at single dose at Arm Right at Hospital for COVID. Medical history included ongoing sleep apnoea. There were no concomitant medications. There were no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced miscarriage on 29Dec2020 13:00. The patient was pregnant while taking BNT162B2. The patient was 4 Weeks pregnant at the onset of the event. Patient last menstrual period date was 24Nov2020. The Pregnancy due to deliver was on 07Sep2021. The pregnancy resulted in spontaneous abortion. Since the vaccination, the patient has been tested for COVID-19 on an unknown date with unknown results. Nasal Swab on 28Dec2020 was Negative. There was no treatment received for the adverse event. The outcome of event was recovering.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agency, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,PVT,,Sleep apnoea,,,,"['Abortion spontaneous', 'Exposure during pregnancy']",1,PFIZER\BIONTECH,OT 925640,NJ,60.0,M,"DVT left calf; This is a spontaneous report from a contactable Physician (patient). A 60-year-old male patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular on 20Dec2020 08:00 at single dose on right arm for COVID-19 immunization. Medical history included Gastric reflux. The patient had no known allergies. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medications included omeprazole (PRILOSEC) and ergocalciferol (VIT D). The patient had not received other vaccine in four weeks. The patient experienced deep vein thrombosis (DVT) left calf on 27Dec2020 09:00 which resulted emergency room visit. Treatment received for the event included Xarelto. The outcome of the event was not resolved. Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/27/2020,7.0,PVT,PRILOSEC [OMEPRAZOLE]; VIT D,,Medical History/Concurrent Conditions: Reflux gastritis,,,['Deep vein thrombosis'],1,PFIZER\BIONTECH,OT 925641,,,F,"reaction to excipient; kidneys tried to shut down; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. A female patient of an unspecified age received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), and potassium (MANUFACTURER UNKNOWN); both via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history included ongoing kidney issues from an unknown date, allergic to antibiotics and pain pills from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, the patient experienced: kidneys tried to shut down and reaction to excipient; which were assessed as medically significant. The consumer stated, ""I looked at the ingredient list: potassium is listed. I have kidney issues and potassium is really bad, my kidneys tried to shut down on me. I'm allergic to ""antibiotics and pain pills."" The clinical outcome of the events, renal failure and reaction to excipient, was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,Kidney disorder,Medical History/Concurrent Conditions: Allergy to antibiotic; Drug allergy,,,"['Reaction to excipient', 'Renal failure']",UNK,UNKNOWN MANUFACTURER, 925642,TN,61.0,F,"Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Mental impairment cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,WRK,LEXAPRO; ; IBUPROFAN,,Medical History/Concurrent Conditions: Breast cancer; Sulfonamide allergy,,,"['Anxiety', 'Asthenia', 'Blood pressure increased', 'Burning sensation', 'Disturbance in attention', 'Dizziness', 'Heart rate increased', 'Mental impairment', 'Peripheral coldness', 'Speech disorder', 'Tremor']",1,PFIZER\BIONTECH, 925643,,,U,"reported increased hand stiffness after vaccination; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation. Medical history included psoriasis and psoriatic arthritis. The patient's concomitant medications were not reported. The patient previously took adalimumab (HUMIRA) and non compliant with Humira. The patient had psoriasis and psoriatic arthritis, reported increased hand stiffness after vaccination on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported ""psoriasis and psoriatic arthritis with increased hand stiffness after vaccination"" and the administration of BNT162B2, based on the reasonable temporal association. The patient's pre-existing medical condition of psoriasis and psoriatic arthritis might have provided alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Psoriasis; Psoriatic arthritis,,,['Musculoskeletal stiffness'],UNK,PFIZER\BIONTECH, 925644,NY,85.0,F,"Confirmed DVT in the left leg; COVID test (PCR swab): positive on 26Dec2020; COVID test (PCR swab): positive on 26Dec2020; This is a spontaneous report from a contactable other healthcare professional. An 85-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# ELO140, expiration date: Mar2021), via an unspecified route of administration in arm (deltoid; unknown side) on 23Dec2020 at single dose for Covid-19 immunisation. Medical history included type 2 diabetes mellitus from 2017 and ongoing, high blood pressure from 2017 and ongoing, atrial fibrillation (A-Fib) from 2019 and ongoing. The patient's concomitant medications were not reported. The patient was administered first dose of the COVID vaccine on 23Dec2020 and then was swabbed for COVID on 26Dec2020, and then on 28Dec2020 her PCR swab was positive for COVID. She was asymptomatic until she started complaining of leg pain. She ordered an ultrasound for the patient on 30Dec2020, and it confirmed a deep vein thrombosis (DVT) in left leg. The patient was being treated with anticoagulant apixaban (ELIQUIS) currently. Caller stated that this could be that it (DVT) is from COVID, but her real question was, could it be from the vaccine? In Pfizer's information packet for patients, there is section on what to tell your provider prior to getting vaccinated. One of the things on there is if you have a bleeding disorder or are on an anticoagulant. There is no explanation as to why it was in the packet of information. Caller has looked everywhere and can not figure out why that is on the FAQ/packet information. The patient was due for the second dose on 13Jan2020, but she was worried and hesitant to approve it. The patient underwent lab tests and procedures which included COVID test (PCR swab): positive on 26Dec2020, ultrasound of the left leg: confirmed DVT on 30Dec2020. The outcome of events was not recovered.; Sender's Comments: There is not a reasonable possibility that event ""COVID test (PCR swab): positive"" is related to BNT162B2 vaccine. The event occurred 3 days after vaccination, when vaccine was not expected to achieve the effect. The event DVT of legs is not considered related to BNT162B2 vaccine. The patient had underlying diabetes and cardiovascular disorders, which are considered as risk factors for DVT. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/26/2020,3.0,UNK,,Atrial fibrillation (Verbatim: A-Fib); Blood pressure high (Verbatim: High Blood pressure); Type 2 diabetes mellitus (Verbatim: Type 2 diabetes mellitus),,,,"['Deep vein thrombosis', 'Pain in extremity', 'SARS-CoV-2 test positive', 'Ultrasound scan abnormal']",1,PFIZER\BIONTECH, 925645,PA,40.0,M,"Patient was poorly responsive to her inhalers that she used for asthma; Persistent shortness of breath and chest tightness starting within a few days after vaccine; Persistent shortness of breath and chest tightness starting within a few days after vaccine; This is a spontaneous report from a contactable physician (patient). A 40-year-old male patient received the first single dose of BNT162B2 (Solution for injection, lot number: EK5730, exp date not reported), via an unspecified route of administration (vaccine location: left arm) on 18Dec2020 04:15 for COVID-19 immunization. Medical history included allergy induced asthma, allergies to cats and dust, and occasional seasonal allergies. Concomitant medication included other vaccine/s received within 4 weeks prior to the COVID vaccine: first dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX, GlaxoSmithKline) administered as single dose via unspecified route of administration (vaccine location: left arm) on 08Dec2020. There were no other medications the patient received within 2 weeks of vaccination. The patient experienced persistent shortness of breath and chest tightness starting within a few days after vaccine (24Dec2020). Patient was poorly responsive to her inhalers that she used for asthma (onset date not reported). She rarely needed the, used about once or twice a year). It was constant, but with periods of improvement followed regression. Will likely seek medical evaluation as it's been over a week now and rather concerning. The patient did not consider the events shortness of breath and chest tightness as serious. Treatment for the adverse events shortness of breath and chest tightness included fluticasone propionate, almeterol (ADVAIR), albuterol, and unspecified anti-allergy medications. Patient did not have covid prior vaccination. Patient was tested for COVID post vaccination wherein patient tested negative for COVID via Covid test rapid on 30Dec2020. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of shortness of breath and chest tightness was not recovered and unknown for the other event.; Sender's Comments: Based on the time association, the possible contribution of BNT162B2 to the events shortness of breath , chest tightness and asthma aggravated cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/24/2020,6.0,PVT,,,Medical History/Concurrent Conditions: Allergic asthma; Allergy to animal; Dust allergy; Seasonal allergy,,,"['Chest discomfort', 'Dyspnoea', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 925646,,,U,"diabetes was high; seeing double vision; Headache on the right side; This is a spontaneous report from a contactable nurse. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) dose number 1, via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had the vaccine in a hospital on a Friday (18Dec2020). No side effect was noted over the weekend. On 21Dec2020, when the patient woke up, s/he was seeing double vision, so s/he went to the doctor; they ran some test (unknown result). Because the patient was having headache on the right side in Dec2020, s/he went back to the doctor on 23Dec2020; the patient was sent to the eye doctor and they ran all kind of test. On 24Dec2020, the only thing they could find was that the patient's diabetes was high, so they kind of felt that what that could have been was kind of coincidental. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The mentioned ""diabetes was high"" is likely an intercurrent disease, unlikely related to the administration of BNT162B2, the COVID-19 immunization. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/01/2020,,PVT,,,,,,"['Condition aggravated', 'Diabetes mellitus', 'Diplopia', 'Headache', 'Laboratory test abnormal']",1,PFIZER\BIONTECH, 925647,MD,45.0,M,"joint pain; it doesn't seem to be feeling well; sweating; Fever; chills; night sweats, that he will randomly start sweating; headache; muscle pain/mild muscle aches; gastric upset; Fatigue; he had mild arm soreness right after he got the vaccine; This is a spontaneous report from a contactable Other-HCP (patient). This 45-year-old male Other-HCP received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, NDC number: 59267-1000-1) on 22Dec2020 at single dose in his right arm for COVID-19 immunization. Medical history and concomitant drug were not reported. It was reported that patient experienced Fever on 27Dec2020 with outcome was recovered on 29Dec2020, chills and night sweats on 27Dec2020 with outcome was not recovered, Headache on 27Dec2020 with outcome was not recovered, muscle pain 27Dec2020 with outcome was not recovered, gastric upset on 27Dec2020 with outcome was Recovering, Fatigue on 27Dec2020 with outcome was unknown, arm soreness on 22Dec2020 with outcome was not recovered, joint pain with outcome was unknown, it doesn't seem to be feeling well with outcome was unknown, sweating with outcome was unknown. All events were serious (medical significant). Caller stated that he thought having a reaction to the vaccination, spoken with Occupational Health at his job and with a doctor, stated everyone is a bit stumped. Caller stated he has had for over a week now, fever, chills, night sweats, that he will randomly start sweating, headache, joint pain, gastric upset, and it doesn't seem to be feeling well. Stated the joint pain is actually more muscle pain. Stated he got the vaccination on Tuesday 22Dec2020, stated he has been having these symptoms for over 5 days now. Stated he does not think this is something infectious, that no one in his family is getting sick, his wife or child are not catching it from him. Stated he tried to do research online for data about delayed side effects, would like to know if we have any information on delayed side effects. Stated he considers these events medically significant because he cannot be cleared to go back to work. Stated he had mild arm soreness right after he got the vaccine, states he had mild muscle aches Wednesday and Thursday, then they went away and came back all on Saturday night and Sunday. Stated he is worried about getting a second vaccine. Stated he tested negative for the COVID on 29Dec2020. Stated he has a CBC and other blood work scheduled for today, results unknown at this time. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,UNK,,,,,,"['Abdominal discomfort', 'Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Malaise', 'Myalgia', 'Night sweats', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 925648,MI,,F,"Tachycardia; Palpitations; had a strong, whole body heat, and flushing; had a strong, whole body heat, and flushing; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 4th of 6 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said her friend is a registered nurse, and received the COVID-19 Vaccine on Monday, 28Dec2020. She said her friend stated she, and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. She had no other symptoms after receiving the COVID-19 Vaccine. There is unknown whether the patient received the treatment or not. The outcome of the events was recovered on 28Dec2020. Information on lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events flushing, feeling hot, tachycardia and palpitations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['Feeling hot', 'Flushing', 'Palpitations', 'Tachycardia']",UNK,PFIZER\BIONTECH, 925649,,,F,"It sounds like to be an allergic reaction; She passed out; Tachycardia; Nausea; Lightheadedness; This is a spontaneous report from a non-contactable physician. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 at single dose to be vaccinated for her protection. Medical history was none. The patient's concomitant medications were not reported. Patient took the Pfizer COVID-19 vaccine and next day she had a very serious reaction. She did not know that if it was due to the vaccine. But she had tachycardia requiring her to go to the emergency room and she passed out and she had nausea and lightheadedness as well. It sounds like to be an allergic reaction. Given the seriousness of tachycardia and passing out as well as the lightheadedness and nausea it sounds too severe just to be a mild immune response. So, it was sort of rare immune response or it was unrelated it was unknown at this time. Outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the compatible time association, the contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No",,,"['Dizziness', 'Loss of consciousness', 'Nausea', 'Tachycardia']",UNK,PFIZER\BIONTECH, 925650,MI,,F,"strong, whole body heat, and flushing; strong, whole body heat, and flushing; Tachycardia; Palpitations; This is a spontaneous report from a contactable Nurse. This Nurse reported for similar events for 6 patients. This is 2nd of 6 reports. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said her friend was a registered nurse, and received the COVID-19 Vaccine on Monday, 28Dec2020. She said her friend stated she, and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient said she became tachycardia and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. She had no other symptoms after receiving the COVID-19 Vaccine. It was unknown whether the patient received the treatment or not. The outcome of the events was recovered on 28Dec2020. Information on lot/batch number has been requested.; Sender's Comments: The reported transient events of whole body heat, flushing, tachycardia and palpitations were likely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship and clinic course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['Feeling hot', 'Flushing', 'Palpitations', 'Tachycardia']",UNK,PFIZER\BIONTECH, 925651,MI,,U,"Serious, weird reaction/had a strong, whole body heat, and flushing; Serious, weird reaction/had a strong, whole body heat, and flushing; Serious, weird reaction/tachycardic; Serious, weird reaction/had palpitations; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is 5th of 6 reports. A patient of unspecified gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter did not know if the patient had received any other vaccines at the same time as the COVID-19 Vaccine, and if the patient had received any other vaccines within the last 4 weeks. It was reporter that the reporter's friend texted her last night, on 30Dec2020, at around midnight. The reporter, and 5 other registered nurses she works with in a hospital, received the COVID-19 vaccine at the same time and had the same exact symptoms she experienced. They had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a weird reaction right after being injected with the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient became tachycardic and had palpitations that lasted a few minutes. The tachycardia and palpitations then slowly resolved in less than 5 minutes. The patient had no other symptoms after receiving the COVID-19 Vaccine. The registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. For treatment information, the reporter didn't believe the patient received any medical attention. Reporter believed that the patient just waited symptoms out, and within 5 minutes the symptoms had gone away. The outcome of the events was recovered on 28Dec2020. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events flushing, feeling hot, tachycardia and palpitations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['Feeling hot', 'Flushing', 'Palpitations', 'Tachycardia']",UNK,PFIZER\BIONTECH, 925652,,,U,"Back of my right leg has a quarter size oblong shape lump it's little bit red but not warm to the touch; Back of my right leg has a quarter size oblong shape lump it's little bit red but not warm to the touch; Back of my right leg has a quarter size oblong shape lump it's little bit red but not warm to the touch, it may be a blood clot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 30Dec2020 18:30 SE for immunization. The patient's medical history and concomitant medications were not reported. Patient received the Pfizer Vaccine the day of reporting: 30Dec2020 at about 06:30 (tonight). Patient felt fine and still felt fine but when was going to rub some lotion on the back of right leg, has a quarter size oblong shaped lump (onset date not reported) which was little bit red but not warm to the touch. Patient didn't do anything to make it happen. Patient doesn't know if it may be a blood clot which was patient's question. ""The blood clot something may be concerned about."" Patient asked ""Is this a blood clot, it could go to my heart and I could die tomorrow? So I am going to call my family doctor but thank you."" The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,,,UNK,,,,,,"['Erythema', 'Limb mass']",UNK,PFIZER\BIONTECH, 925656,MA,30.0,F,"Redness, swelling, itchiness at injection site (left deltoid) that began 7 days after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,None,None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 925657,ND,60.0,F,"Patient presented to the ED with c/o of injection site reaction of firmness approximately baseball sized to the left deltoid and redness. This is not what triggered the visit. The reason for the visit was that she felt itchy all over, and this started at approximately 4:30 pm. Patient was given IV normal saline, benadryl 50 mg IM and Pepcid 20 mg IV. Patient had significant improvement in itching and was discharged from the ED at 6:10 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,PHM,Fluconazaole 150 mg; Furosemide 20 mg; losartan 25 mg;,COVID-19,"HTN; renal calculi, tobacco abuse; obesity; chronic pain of right knee; snores;",,No Known Allergies,"['Blood albumin decreased', 'Blood creatinine decreased', 'Blood glucose increased', 'Blood urea nitrogen/creatinine ratio increased', 'Blood urea normal', 'Injection site erythema', 'Injection site induration', 'Mean cell volume normal', 'Monocyte count normal', 'Monocyte percentage', 'Pruritus', 'Red cell distribution width normal']",1,MODERNA,IM 925658,NY,32.0,M,Parasthesia on injection arm and parasthesia on ipsilateral skull base,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Prozac, omeprazole",,Depression,,,['Paraesthesia'],1,PFIZER\BIONTECH,IM 925659,TX,36.0,F,"There is swelling, hardness, redness and pain at the site of injection with some itching. The area also feels warm compared to other arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,None,none,none,,Sulfa drugs: Nausea/vomiting,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 925660,IN,39.0,F,"Woke up at 3am with the chills took my temp was 99.8. Took my morning medicines and then some ibuprofen, was having body aches and severe chills. Went back to bed and took my temp an hour later was 101.0. Had body aches, chills, thirst, weakness, headache for the rest of the day. Temperature went from 99.0 to the highest of 102.0. Got ahold of covid 19 hotline at work, they said it was a reaction to the shot and should be gone within 72hrs. If not then I would need to get covid tested. Got ahold of my pcp and they ordered a covid test but I told them what the hotline had said and that I would wait to get one done. It has been 24 hour since and now I no longer have a fever and am feeling better just tired.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"Lisinopril, hydrochlorothiazide, lexapro, metoprolol,",None,High b/p...taken care of with medication,,Phenobarb,"['Asthenia', 'Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Pain', 'Thirst']",UNK,PFIZER\BIONTECH,SYR 925661,NY,49.0,F,"Right after injection had vaccine taste in her mouth bodycache, chills, headache, nosebleed left nostril,could not move had joint pain, nausea and loss of appetite ,arm tenderness swollen"" Popeye arm"" temp 99.5",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PVT,,,,,,"['Arthralgia', 'Body temperature increased', 'Chills', 'Decreased appetite', 'Dysgeusia', 'Epistaxis', 'Headache', 'Immediate post-injection reaction', 'Mobility decreased', 'Nausea', 'Pain', 'Peripheral swelling', 'Tenderness']",1,MODERNA,IM 925662,MO,28.0,F,"1 week out injection site red, warm, swollen, itchy, slightly painful visiting PCP January 11th.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/04/2021,7.0,PVT,,,,,"sulfa, mouth wash, coconut","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 925663,FL,34.0,F,dry heaving and nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Human chorionic gonadotropin negative', 'Nausea', 'Retching']",1,MODERNA,IM 925664,CT,57.0,F,"On 1/5/21 pm sore arm . On 1/5/21 noontime 1000 mg Tylenol. On 1/6/21 5 am body aches during early am got up at 5 am. Took Tylenol 1000mg. Went to work. Around 9am of 1/6/21 chills more pronounced body aches. Temp 99.3. Continued to feel poorly, rechecked temp 1.00 pm. Now 99.9. Sent home. At 2:15 pm temp 104.00. More severe chills and body pain, nauseous. Toast for dinner, Tylenol again at 6 pm , recheck temp 100.8. Went to bed. 1/7/22 am some body aches, not as severe, nauseous and migrai. Type headache. Did no take temp, because didn't feel one. Call to nurse at covid vaccine holiness. Check temp while on phone 97.4.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,"Vitamin D 2000 iu, vitamin c, calcium, prantoprazole 40 mg",,Psoriatric arthritis,,"Percocet , otezla. Hydroxychloroquie methotrexate.","['Body temperature increased', 'Chills', 'Feeling abnormal', 'Migraine', 'Nausea', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 925665,IN,68.0,F,"1-5-2021 uncontrollable Shaking of entire body Fever started at 99.1 at 9:30 pm by 11:30 fever was 101.1. I took 2 tylanol at 9:30 and 2 more at 11:30 pm and went to bed the shaking had subsided by about 11:00pm and woke up about 1 am and the fever was gone. I woke up at 5 am on 1-6-2021 with the shaking, but no fever and the shaking just lasted about 45 minutes. I had a headache off and on 1-6-2021 and of course the sore arm. I was very tired the 2nd day, too.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,Carvedilol Cinnamon Niacin Lutein Beta Carotene Zinc Preservision Flonase Warfarin Spironolactone Montelukast Elderberry Vitamin C Citirizine D3 Fish Oil,Sinus drainage due to allergies is ongoing problem.,Allergies to dust and polen,,Erythromycin Preservatives in personal hygiene products,"['Fatigue', 'Headache', 'Pain in extremity', 'Pyrexia', 'Tremor']",1,MODERNA,SYR 925666,NY,35.0,M,"01/06 -Upon waking: generalized body ache, more intense left arm ache -12PM: intermittent chills without rigors -4PM: diffuse tension headache rated 1/10 -No other signs and symptoms 01/07: no change compared to 01/06.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,None,None,None,Headaches related to Tdap vaccinated 2010. Resolved after 24hours. Unknown brand name.,None,"['Chills', 'Pain', 'Pain in extremity', 'Tension headache']",1,PFIZER\BIONTECH,IM 925670,ME,63.0,F,"fatigue on onset. 7th day, left arm felt heavy, tingly, injection site had a lump, red with lumps inside the lump. Went to clinic 01/05/21, Dr marked the site. Advised to apply ice and use topical benedryl (I did not have at home). Next day, worsened, injection site, very red, itchy, burning, and had redness had spread beyond the markings of Dr. On 01/06/21 went to clinic, saw PAC. Put me on antibiotics. Stated allergic reaction and looked like cellulitis too. Today arm is less swollen, but still red and itchy. Going back to clinic to see Dr Friday 01/08/21 at 10:30 am",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,WRK,Vitamin D Q Saturday,no,no,,"Coffee, corn, carrots, Bakers yeast, Candida yeast","['Cellulitis', 'Fatigue', 'Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site pruritus', 'Limb discomfort', 'Paraesthesia']",UNK,MODERNA,IM 925676,VA,61.0,M,"Previously had Covid 19 May of 2020, received the Moderna vaccine on 12/31/20. That evening temp of 102.4, SI joint back pain, body aches until Saturday 1/2/21, also has shaky hands, feels anxious, nervous, racing thoughts, foggy + restless. Difficulty sleeping Blood pressure 156/101",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PUB,PCP,None,"Atenalol 10mg Afib - 81mg aspirin, GERD Nexium 40mg",,,"['Anxiety', 'Arthralgia', 'Body temperature increased', 'Feeling abnormal', 'Insomnia', 'Nervousness', 'Pain', 'Restlessness', 'Tachyphrenia', 'Tremor']",2,MODERNA, 925712,PA,25.0,F,"Patient experienced headaches the evening after injection, the day following vaccination patient reports dizziness, shaky legs, and face/throat numbness and tingling. Emergency room visit on 1/4/2021. Patient reports botox lip injections approximately 6 months prior.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,WRK,,,,,,"['Dizziness', 'Headache', 'Hypoaesthesia', 'Paraesthesia', 'Pharyngeal hypoaesthesia', 'Tremor']",1,MODERNA,IM 925736,OK,,U,"herpez zoster; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided. On an unspecified date, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to the patient vaccination, the patient presented herpes zoster. As a direct and proximate result, the patient had been treated by a medical provided. Additionally, the symptoms had been resulted in physical limitation not presented prior vaccination. The patient sustained severe and permanent injuries; the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. As a direct and proximate result, the patient suffered severe and permanent physical injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).",Not Reported,,Not Reported,Not Reported,,Yes,N,,,,UNK,,,,,,['Herpes zoster'],UNK,MERCK & CO. INC., 925740,LA,,U,"herpes zoster; post herpetic neuralgia; Information has been received regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, anatomical location, lot number and expiration date were not provided). On an unspecified date (reported as ""shortly after receiving the vaccine""), the pt suffered herpes zoster and post herpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of the vaccine, the pt's symptoms resulted in physical limitations not present prior to using the product, and experienced mental and emotional distress due to resulting physical limitations and seriousness of the condition. The pt suffered serious, severe, progressive, permanent, and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reported events were not resolved. The events of herpes zoster and post herpetic neuralgia were considered to be related to zoster vaccine live (ZOSTAVAX) by the reporter. Upon internal review, the events of herpes zoster and post herpetic neuralgia were considered to be disabling.",Not Reported,,Not Reported,Not Reported,,Yes,N,,,,UNK,,,,,,"['Herpes zoster', 'Post herpetic neuralgia']",UNK,MERCK & CO. INC.,OT 925742,TN,23.0,F,"Fatigue and overall lethargic feeling/Sore throat; Dark colored urine despite pushing fluids; Frequent urination; Migraine; Swollen joints and could not move arm that received vaccine in; Swollen joints and could not move arm that received vaccine in; Stomach pains, nausea, diarrhea, swollen lymph nodes; Stomach pains, nausea, diarrhea, swollen lymph nodes; Stomach pains, nausea, diarrhea, swollen lymph nodes; Stomach pains, nausea, diarrhea, swollen lymph nodes; Chills, body aches, spiked fever of 102.; Chills, body aches, spiked fever of 102.; Chills, body aches, spiked fever of 102.; Fatigue and overall lethargic feeling; Fatigue and overall lethargic feeling; Sore throat; The initial case was missing the following minimum criteria: Invalid for no adverse effect. Upon receipt of follow-up information on (31Dec2020), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EH9899, Expiry Date: Mar2021), intramuscular at Deltoid Left on 29Dec2020 07:20 at single dose for COVID-19 immunization. Medical history included covid-19 from Nov2020 to an unknown date (had covid in the middle of November), surgeries from an unknown date and unknown if ongoing (She also had previous surgeries and has foreign objects in her body. Those areas were super hot. Those antibodies were like rejecting those foreign bodies because they were super hot.) There were no concomitant medications. Received call from RN calling about the Pfizer COVID vaccine. She got the vaccine on Tuesday and had a terrible reaction to it and she called a couple of different hotlines and spoke with the people who administered it. She confirmed that she did not report to Pfizer though. The people at her work that she spoke with told her to go to an Urgent care. They told her she should not get it within 90 days of having COVID. She had COVID in the middle of Nov2020. She went ahead and got it on Tuesday and had this terrible reaction. She would like to know if she should get the second dose or wait until 90 days after she had COVID and start again. There was no prescriber. She received it as part of the (hospital name withheld) front line health worker precaution. She thought that this was a normal reaction, but was told it was not. Fatigue and overall lethargic feeling happened exactly 12 hours after receiving. She works night shift and that is her base line. Pretty much everything hit after that within an hour. She was told low grade fever was normal, but not 102. She never spikes fevers, so it is medically significant. It persisted for 24 hours and is better today. She is on the 48 hour mark now. Stomach pains, nausea, diarrhea, lymph node swelling all over, including swelled armpits and groin area, Migraine, Frequent urination, were also listed as side effects. She was trying to push more fluids but her urine was dark color more than normal, despite pushing fluids. Swollen lymph nodes in her groin and armpits were concerning. Her head is lumpy. Meaning, she can feel swollen lymph nodes in back of neck area. Migraine was consistent through 24 hours and now has improved. Urine color remains dark and she will keep an eye on color. She had swollen joints, but really terrible swollen joints, and she could not move the arm that she got the vaccine in. She could not lift to above shoulder height. AE Details and time of onset: Sore Throat 12:00 on 29 Fatigue and overall lethargic feeling 20:00 Chills, body aches, spiked fever of 102: 21:00 Stomach pains, nausea, diarrhea, swollen lymph nodes- 21:00 Migraine- 21:00 Frequent Urination 23:00 Dark colored urine despite pushing fluids 23:00 Swollen joints and could not move arm that received vaccine in: 21:00. ER or physician's office required: Went to urgent care 36 hours after administration. No treatment given. She just wanted to make sure no additional infection was causing anything weird. All test were negative. Prior Vaccinations (within 4 weeks): none. Events Swollen joints and could not move arm that received vaccine in, Stomach pains, nausea, diarrhea, swollen lymph nodes, Chills, body aches, spiked fever of 102 were serious with criteria of medically significant, while the other events were non-serious. The outcome of the event Fatigue and overall lethargic feeling/Sore throat (Condition worsened) was unknown, the outcome of the events Swollen joints and could not move arm that received vaccine in, Chills, body aches, spiked fever of 102., Migraine, Dark colored urine despite pushing fluids, Frequent urination was recovering, while the outcome of the other events was not resolved.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported events due to temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,,,Medical History/Concurrent Conditions: COVID-19 (had covid in the middle of November); Surgery,,,"['Abdominal pain upper', 'Chills', 'Chromaturia', 'Diarrhoea', 'Fatigue', 'Injected limb mobility decreased', 'Joint swelling', 'Laboratory test normal', 'Lethargy', 'Lymphadenopathy', 'Migraine', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pollakiuria', 'Pyrexia']",UNK,PFIZER\BIONTECH,OT 925743,IL,48.0,F,"anaphylactic reaction; neuropathy in fingers, toes, roof of mouth/lips; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL0140) at single dose on left arm on 30Dec2020 at 09:00 for COVID-19 immunization. Medical history included asthma (controlled); hypertension diagnosis 1 year ago; allergies to medications, food and environmental. Concomitant medications in two weeks included antihypertensives - amlodipine and losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Dec2020 at 9:15 AM, the patient experienced anaphylactic reaction within 10 minutes of administration, neuropathy in fingers, toes, roof of mouth/lips. Neuropathy continued to date. The adverse events resulted in emergency room/department or urgent care. The patient received treatment Epinephrine IM (intramuscular) and IV (intravenous) steroids. The outcome of events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of anaphylactic reaction and neuropathy peripheral due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including serum tryptase and nerve conduction studies, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,;,,Medical History/Concurrent Conditions: Asthma; Drug allergy; Environmental allergy; Food allergy; Hypertension,,,"['Anaphylactic reaction', 'Neuropathy peripheral']",1,PFIZER\BIONTECH, 925744,,,F,"brain felt swollen; glands were also swollen; bad headache; minimal arm pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. Medical history included lupus-like history and chronic Lyme disease. The patient's concomitant medications were not reported. The patient stated she received the first vaccine dose on 30Dec2020 and had minimal arm pain, fatigue that went to a very bad headache on Thursday (31Dec2020). By Friday headache and fatigue were terrible until this morning. Her brain felt swollen and her glands were also swollen on 03Jan2021. The patient stated that she called healthcare professional (HCP) and was told that her body was ""having an auto immune response"", ""due to a lupus like history and a history of chronic Lyme disease and to hydrate well"". It was so hard to talk, she was so fatigued. Her doctor compared it to like an encephalopathy. The patient was feeling better today but was concerned about taking the second dose. She works in a facility with a lot of Covid-19 patients. The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product to the development of event brain felt swollen cannot be totally excluded. Medical history of lupus-like history and chronic Lyme disease may provide plausible alternative explanations for the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Lupus-like syndrome; Lyme disease,,,"['Brain oedema', 'Fatigue', 'Headache', 'Lymphadenopathy', 'Pain in extremity', 'Speech disorder']",1,PFIZER\BIONTECH, 925745,NY,34.0,F,"numbness and weakness in left arm; numbness and weakness in left arm; had a brachial plexus pathology; her grip and fine motor are affected in her left arm/she could not do her job; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), via an unspecified route of administration in right arm on 21Dec2020 at single dose for Covid-19 immunisation. Medical history included ongoing birth control. No other medical history. Concomitant drug included other medication she took for birth control. On 29Dec2020, the patient experienced numbness and weakness in left arm, had a brachial plexus pathology, went to the emergency department on 30Dec2020 and was seen by one of the facility doctors and stated this doctor had her on steroids for treatment. She got the vaccine in her right arm, stated her grip and fine motor are affected in her left arm. States this was disabling since she could not do her job. She was following up with neurology on Monday (unspecified), that she had a CT scan of her neck and it was normal. Only other medication she was taking was for birth control, but she did not feel like it was relevant. The outcome of events numbness and weakness in left arm was recovering, while outcome of other events was unknown. This case was reported as serious, seriousness criteria was disabling.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/21/2020,12/29/2020,8.0,UNK,,Birth control,,,,"['Brachial plexus injury', 'Computerised tomogram neck', 'Fine motor skill dysfunction', 'Grip strength decreased', 'Hypoaesthesia', 'Impaired work ability', 'Muscular weakness']",UNK,PFIZER\BIONTECH, 925746,,35.0,F,"it hits a nerve; perceived it along the face still and the arm; Bell's Palsy; numbness in a small area of her tongue; right eye was irritated a little dry; right eye was irritated a little dry; right sided ear pain; fluid in the ear but no infection; This is a spontaneous report from a contactable health care professional (nurse practitioner). A 35-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on the right side on 21Dec2020 for Covid-19 immunization. Medical history included intermittent hives. Concomitant drug included ongoing cetirizine hydrochloride (ZYRTEC) 5 mg for intermittent hives. The reporting nurse practitioner saw a patient on 31Dec2020 who was vaccinated on 21Dec2020 and had a Bell's Palsy reaction (reported as not serious). She did some research and saw no more incidents in the general population but she wanted to report this. She also wanted to get more information on if the patient should proceed with dose number 2 of the vaccine. The patient developed the Bell's Palsy within 5 minutes after getting the vaccine. She thought it was because she was anxious to get the vaccine, so she brushed it off. The Bell's Palsy was still occurring but per the patient it had improved. On exam she did not have any weakness, facial droop or dumbness with sharp or dull testing. The patient perceived it along the face still and the arm. The reporting nurse practitioner said that the arm was probably not Bell's Palsy, but more related to getting the vaccine in the arm and it hits a nerve. Patient stated that her smile was also unequal and it was difficult for her to close her right eye, although now (as of 31Dec2020) she can. Her right eye was irritated a little dry. Regarding treatment, the patient was started on steroids on 31Dec2020. She did not start her on an anti-viral as she did not want it to impact her immunity to the vaccine. The patient also complained of right sided ear pain. She was unsure if that was related to the Bell's Palsy, but it was also on the right side. There was fluid in the ear but no infection. The pain was still ongoing. The patient also mentioned numbness in a small area of her tongue when she first got the vaccine. This was still ongoing. Outcome of Bell's Palsy was resolving. Outcome of the event numbness in a small area of her tongue, right sided ear pain was not resolved. Outcome of the other events was unknown. The reporting nurse practitioner stated that this was not serious as this was a mild case and was thankfully resolving. The reporting nurse practitioner comment that nothing of history was relevant besides for the last several months (as of 31Dec2020) the patient had been taking 5mg of cetirizine hydrochloride for intermittent hives. She wondered if she had not been taking it how she would have reacted or if the reaction would have been more severe. Information on the lot/Batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of Bell's Palsy cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,UNK,ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Hives,,,"['Dry eye', 'Ear pain', 'Eye irritation', 'Eyelid function disorder', 'Facial asymmetry', 'Facial paralysis', 'Hypoaesthesia oral', 'Injection site nerve damage', 'Middle ear effusion', 'Pain']",1,PFIZER\BIONTECH, 925747,MO,47.0,F,"Pitting edema/Edema: It was her feet, ankles, and 3/4 way up her shins.; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730, expiry date: Mar2021), intramuscular in the left deltoid on 17Dec2020 at 07:15 at single dose for COVID-19 immunization. Medical history included ongoing neuralgia since 2003 (has nerve pain in her face and neck. It has never caused swelling and that she has had it for a long time. Symptoms started 17 years ago, became apparent in 2009), ongoing hypothyroidism since 2003 (Diagnosed about 17 years ago. Nothing has changed medication wise). The patient's concomitant medications were not reported. The patient reported that she got the vaccine on 17Dec2020. On 25Dec2020, her shoes felt snug and by the next day she had 4 plus pitting edema. She could not fit in the shoes. She had the pitting edema for several days. She said that she went and bought compression stockings to help with the edema. It was her feet, ankles, and 3/4 way up her shins. It was more of the pedal area that was pitting. The patient further reported that she never had pitting edema before and the only thing new she had was the vaccine. Therapeutic measures were taken as a result of the event which included compression stockings. The patient was recovering from the event.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported event pitting edema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/26/2020,9.0,PVT,,Hypothyroidism; Neuralgia (.),,,,"['Oedema', 'Oedema peripheral']",1,PFIZER\BIONTECH,OT 925748,MI,24.0,F,"a strong, whole body heat, and flushing; a strong, whole body heat, and flushing; Tachycardia; Palpitations; This is a spontaneous report from a contactable Nurse. This Nurse reported similar event for 6 patients. This is 3rd of 6 reports. A 24-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Pfizer employee reporting on behalf of a friend, reported her friend texted her last night, 30Dec2020, at around midnight. The nurse and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. Caller said she had a strong, whole body heat, and flushing. She said she became tachycardic and had palpitations that lasted a few minutes. Caller said there were 5 other registered nurses that received the COVID-19 Vaccine at the same time and had the same exact symptoms she experienced. Outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 vaccine cannot be excluded for events flushing, feeling hot, tachycardia and palpitations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['Feeling hot', 'Flushing', 'Palpitations', 'Tachycardia']",UNK,PFIZER\BIONTECH, 925749,MI,49.0,F,"she had a strong, whole body heat, and flushing; she had a strong, whole body heat, and flushing; Tachycardia; Palpitations; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 6th of 6 reports. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said her friend is a registered nurse, and received the COVID-19 Vaccine on Monday, 28Dec2020. She said her friend stated she, and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. She had no other symptoms after receiving the COVID-19 Vaccine. The registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter did not know if the patient received any other vaccines at the same time as the COVID-19 Vaccine, and if had received any other vaccines within the last 4 weeks. The patient works at a hospital but doesn't believe that she received any medical attention. she believed just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020. Information on lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported whole body heat, flushing, tachycardia and palpitations, and the administration of BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Feeling hot', 'Flushing', 'Palpitations', 'Tachycardia']",UNK,PFIZER\BIONTECH, 925750,MO,65.0,F,"Rash; Welts; she had a very sore arm; This is a spontaneous report from a contactable nurse (patient herself). A 65-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid Vaccine, lot EH9099 or EH9899), via an unspecified route of administration in her left deltoid on 22Dec2020 09:32 at single dose for Covid-19 immunisation. Medical history included broken toe for 3 weeks. This was from her taekwondo and doesn't complain. No history of all previous immunization with the Pfizer vaccine considered as suspect drug. There were no additional vaccines administered on same date with Covid-19 vaccine. There were no concomitant medications. On 24Dec2020, she broke out in a rash on different parts of her body. She said the rash would come and go. She said she then had welts appear on different parts of her body and the welts would come and go. She said on the 3rd day, she had rash and welts together only on her trunk. She said on days 4, 5, and 6, she would have either a rash or welts come and go on different parts of her body. She clarified she had the rash and welts on her hands, wrists, ankles, and body. She reported that the rash and welts were serious-medically significant. On 22Dec2020, she had arm soreness and was just inconvenient and uncomfortable. She said she was not saying that what she was experiencing was related to receiving the COVID-19 Vaccine, but she doesn't know what else can be causing the rash and welts. She said she hasn't changed anything she has been eating or doing. She said she was worried about taking the 2nd COVID-19 Vaccine dose. She used Hydrocortisone 1% cream, Equate brand (reported to be expired) and took an oatmeal bath. She also took Benadryl and brand of Zyrtec called Wal-Zyr. Her height was 175cm, weight was 63kg. The rash and welts recovered on 30Dec2020; arm soreness recovered on 23Dec2020. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events rash and urticaria cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,,,"Medical History/Concurrent Conditions: Toe injury (She said she has had a broken toe for 3 weeks from her taekwondo, and doesn't complain.)",,,"['Pain in extremity', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH, 925751,,,F,"Saturation down to 84%; Temperature of 101.3; Rapid pulse having some difficulty; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, on 30Dec2020, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The reporter is working in long term in Nursing care facility. It was reported that they have a resident who recovered from COVID. They are having some questions following the guidelines stuff, just kind of asking some more questions. Just one of their resident had temperature of 101.3, saturation down to 84%, 'frustration' at 24% and rapid pulse having some difficulty. The patient was put in her bed. The reporter contacted the doctor in house. 'The reporter wanted to see if any of the recommendation were for (incomplete sentence). The long term care facilities recovered COVID, the reporter wanted to know any of the lasting short term and any guideline for treating. They were all recovered COVID, all of two of the resident two weeks or more out and we (Further clarification was unknown) just had the vaccine yesterday' (as reported, pending clarification). Outcome of the events was unknown. Information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,,,UNK,,,,,,"['Body temperature increased', 'Frustration tolerance decreased', 'Heart rate increased', 'Oxygen saturation decreased']",UNK,PFIZER\BIONTECH, 925753,NY,46.0,F,"Fainting; Red Palms; blotching; sweating profusely; heart palpitations; Chest pain; Elevated BP; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 09:15 at single dose on left arm (Lot number: ek9231) for COVID-19 immunisation. Medical history included asthma, bronchitis, mitral valve regurgitation, herpes, depression, ADHD. COVID prior vaccination: Yes. Known allergies: tramadol, milk products. No other vaccine in four weeks. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion, and, losartan/hydrochlorothiazide. The patient experienced red palms/blotching, sweating profusely, heart palpitations, chest pain and fainting, elevated BP, all on 28Dec2020 09:15. All these events required Emergency room visit. Therapeutic measures were taken as a result of the events included 50 mg of Benadryl, 60 mg of Prednisone, omepresol. No COVID tested post vaccination. Outcome of events was recovered with sequelae.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,ADDERALL; ; LOSARTAN/HYDROCHLOROTHIAZIDE,,Medical History/Concurrent Conditions: ADHD; Asthma; Bronchitis; COVID-19; Depression; Herpes infection; Milk allergy; Mitral valve disease,,,"['Blood pressure increased', 'Chest pain', 'Erythema', 'Hyperhidrosis', 'Palpitations', 'Rash macular', 'Syncope']",1,PFIZER\BIONTECH, 925754,,,U,"I have a sleep problem almost eight hours; I was so tired; Headache; My arm was sore for 24 hours; so stiff; This is a spontaneous report from a contactable physician. A 69-year-old patient of an unspecified gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVD-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dose of the vaccine and had a pretty significant reaction, one say serious to moderate reaction. The patient's question was do they know yet if you take a second shot was your reaction get even worse because the patient had a sleep problem almost eight hours. The patient was so tired, had headache and so stiff, arm was sore for 24 hours. The patient was a little afraid to take a second shot. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agencys, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Fatigue', 'Headache', 'Musculoskeletal stiffness', 'Pain in extremity', 'Sleep disorder']",1,PFIZER\BIONTECH, 925755,NY,50.0,F,"feeling close to loss of consciousness; intense chest pressure/tightness; shortness of breath; chills while driving home; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the left arm, on 02Jan2021 at 11:30 (at the age of 50-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included ibuprofen (MANUFACTURER UNKNOWN). The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home on 02Jan2021 at 12:00. The patient did not receive any treatment for the events. The clinical outcome of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath cannot be excluded, considering the plausible temporal relationship. The underlying predisposing condition of penicillin allergy may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,,,,,,"['Chest discomfort', 'Chills', 'Depressed level of consciousness', 'Dyspnoea']",1,PFIZER\BIONTECH, 925756,LA,66.0,F,"Right sided facial & top lip Numbness & recurring pain; Right sided facial & top lip Numbness & recurring pain; Right sided facial & top lip Numbness & recurring pain; This is a spontaneous report from a contactable consumer reporting for herself. A 66-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via unspecified route of administration on 29Dec2020 13:30 on left arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. Medical history included Hypertension, Reflux and low back pain. Concomitant medications included ibuprofen, dicycloverine hydrochloride (BENTYL), Valsartan and omeprazole. The patient previously took codeine, Bactrim, Zyrtec and experienced allergies. The patient experienced Right sided facial and top lip Numbness, recurring pain on 31Dec2020 16:00. All events resulted in emergency room visit and Hospitalization on 31Dec2020 for 1 day. The patient underwent lab tests and procedures, which included Cat scan, MRI, ultrasound of heart and labs on unspecified dates, Nasal Swab/Covid 19 test on 01Jan2021 with negative result. The outcome of the events were not resolved.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/29/2020,12/31/2020,2.0,PVT,; BENTYL; ;,,Medical History/Concurrent Conditions: Hypertension; Low back pain; Reflux gastritis,,,"['Computerised tomogram', 'Echocardiogram', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Laboratory test', 'Magnetic resonance imaging', 'Pain', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 925757,NY,58.0,F,"hives on her legs; a slight rash on abdomen (started morning on the next day when she woke up) and it spread to her legs (leg rash started 2 days later in the morning); This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 29Dec2020 10:30 at single dose for COVID-19 Immunization. No medical history. No family medical history. There were no concomitant medications. Patient received first dose last Tuesday, 29Dec2020, at the hospital. The next day, she had a slight rash on abdomen (started morning on the next day when she woke up) and it spread to her legs (leg rash started 2 days later in the morning). It was a pretty severe case of hives on her legs now (31Dec2020). Spread to legs and now has hives on legs was reported as worsened. Physician's office visit involved. She had a question. Her doctor prescribed a dosing pack of prednisone to get rid of the hives and her question was, will it affect the effectiveness of the vaccine if she takes it, also, is it ok to get 2nd dose in 2 weeks. She confirmed she had not taken the prednisone yet. There was no prescriber. She received it because she is a healthcare worker. Patient asked if there is any recommendation on getting pre medicated with ex: Benadryl before getting the vaccine. No previous history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect product. No medications prior vaccinations (within 4 weeks). No test done. This is a serious report. The slight rash on abdomen, spread to legs and now has hives on legs was considered medically significant per reporter. The outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events rash and urticaria cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Rash', 'Urticaria']",1,PFIZER\BIONTECH,OT 925758,AK,,M,"experienced eye puffiness; light headed ness; scratchy throat; This is a spontaneous report from a non-contactable consumer via Pfizer Sales Representative. A male patient (Health care worker) of an unspecified age and gender received BNT162B2(Pfizer BioNTech COVID-19 vaccine) via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient experienced eye puffiness, light headed ness and scratchy throat 10 minutes after vaccination in Dec2020. Reaction was not considered anaphylaxis. Patient received epinephrine, Pepcid and Benadryl in the ED, felt completely back to normal within an hour and was released. Event took place after use of product. The outcome of events was recovered in Dec2020. No follow-up attempts are possible; information about batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Dizziness', 'Periorbital swelling', 'Throat irritation']",UNK,PFIZER\BIONTECH, 925759,CA,21.0,F,"1825 Pt received the Pfizer vaccine. Patient sat in chair being monitored for 15 minutes. At 1832 pt felt lightheaded and fainted, emergency response CALLED. Patient appeared pale and diaphoretic. RNs assisted patient down to the floor with head supported with jacket and legs elevated. 1837 Patient's vital signs BP: 101/59, HR: 60, o2: 97%. Patient woke up stating that she is ok. Emergency response arrived 1838. Continued to monitor patient, @ 1845 BP: 110/71, HR: 64, o2:98%. Pt states feeling better, offered juice, pt able to tolerate 1 cup of apple juice with no complications. 1850 patient states feeling better, assisted patient to sitting position from lying down. VS obtained BP: 96/57, HR: 72, o2: 97%. Emergency response recommended patient to to the Emergency Department, but patient refused. States that she is going to go home. Advised that she call for a ride, and patient agreed. 1855 Assisted patient in the standing position, BP: 99/63, HR: 65, o2: 96%. Pt was able to tolerate more apple juice, denies any lightheaded, dizziness or headache. Patient stated that her ride was on the way. Patient agreed and continued to be monitored for another 15 minutes. Pt discharged @ 1915 in stable condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Not known,Not known,Not known,,No,"['Dizziness', 'Hyperhidrosis', 'Pallor', 'Syncope']",1,PFIZER\BIONTECH,IM 925760,NH,44.0,F,"Severe joint pain, migraine headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Abilify, metroprolol, duloxetine, Effexor XR, lamotrigine, pantoprazole, sprintec birth control, b12, amlodipine",N/a,"Anxiety, depression, obesity, high blood pressure, migraines",,"Toradol, soma, ibuprofen, metformin","['Arthralgia', 'Migraine']",2,PFIZER\BIONTECH,IM 925762,ID,32.0,F,"Large red area with prominent swelling, appearing 1 week after vaccine administration. Warm to touch and itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,None,"Sinus infection, treated with Augmentin",None,,None,"['Erythema', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,IM 925763,IL,60.0,F,"""Hot, flushing. took Benadryl liquid several doses, chest tightness and shortness of breath, resolved by next morning""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,tree nuts gabapentin ceclor demerol tegretol ultram,"['Chest discomfort', 'Dyspnoea', 'Hot flush']",1,MODERNA,IM 925764,AR,36.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA After receiving the vaccine developed symptoms later that evening, fatigue, muscle aches (nighttime only) and headache that was relieved with Tylenol .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PUB,"yzal, Vitamin C & D Probiotic, Metformin, Topamax, Zoloft",seasonal allergies and cold,seasonal allergies,,NKDA,"['Fatigue', 'Headache', 'Myalgia']",UNK,PFIZER\BIONTECH, 925765,OH,30.0,F,Pt presented back to clinic on 1/7/21 and shared adverse event of numbness/tingling on right side of face and right leg (same side as vaccine was given). She was treated by PCP for potential bells palsy.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,unknown,none,Raynaud's syndrome (2016 note in EMR),,Latex,"['Facial paralysis', 'Hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 925766,NJ,74.0,M,"Second day (Tuesday 1/5/21) swelling and some soreness on inside of throat right side. Wednesday 1/6/21 swelling had spread significantly to inside the right side of mouth and tongue also affecting right jaw. By 3 Pm that day my tongue was numb and swollen on the right side as well as the right side of my mouth and jaw. I could only chew, eat, and swallow effectively on the left side of my mouth using the left side of my tongue to negotiate eating. I could only this with small amounts of food. By that evening about 4 hours later I could eat , chew etc. pretty good but the swelling & discomfort remained but reduced to a functional level. Today, Thursday 1/7/21, the soreness and discomfort remains inside throat, mouth, tongue and jaw all on the right side.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PHM,None,None,none,,None,"['Discomfort', 'Dysphagia', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Mastication disorder', 'Mouth swelling', 'Oropharyngeal pain', 'Pharyngeal swelling', 'Swelling face', 'Swollen tongue']",UNK,MODERNA, 925767,,60.0,F,12/30: received Moderna Vax Jan. 1: left upper arm (injection site) with redness and swollen Jan. 6 & 7: left upper arm still with redness and tender to touch She?s been taking over the counter meds and hasn?t required a visit to her PCP.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/01/2021,2.0,UNK,,,,,,"['Injection site erythema', 'Injection site swelling', 'Tenderness']",1,MODERNA,IM 925768,NY,33.0,F,"After 6-10 minutes of the injection , I started having shooting pain from the injection site, through my left clavicle area to around the back of my neck. After 15 minutes those muscles described started tensing and my muscles in the back of my neck tightened to the point I can?t look left to right (turning motion). It?s now Almost 3 hours after and symptoms remain same.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,,None,"Diabetes, asthma, PCOS, chronic pain, depression, anxiety",,Levaquin Toradol,"['Injection site reaction', 'Mobility decreased', 'Muscle tightness', 'Neck pain', 'Pain']",1,PFIZER\BIONTECH,IM 925769,DE,46.0,F,"Chills, body sore, temp 101.2",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,"Protonix,",None,None,,Bactrim DS,"['Body temperature increased', 'Chills', 'Pain']",UNK,MODERNA,IM 925770,MN,60.0,F,"joints became achy and continued to be extremely achy thru the night with extreme headache until about 6pm 1/6/21, ran a fever thru the night also Felt as though I had COVID again as was positive on 11/2/2020",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,MIL,none,none,IBS,,none,"['Arthralgia', 'Headache', 'Pyrexia']",UNK,MODERNA, 925771,,46.0,F,"Headaches, body aches, fever, chills, x3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 925772,NY,34.0,F,"Received the vaccine 1/5 at 8:09 am. She was observed for 15 minutes and had no symptoms. Next day, 1/6, she called work to say she had chills and headache and would not be reporting to work. At 2:00 pm, she felt her heart racing, and noticed face and lip swelling and tightness in her throat. She called her PMD who directed her to go to urgent care. At urgent care, she got an EKG, IV fluids, IV steroids, and IV antihistamine. Symptoms resolved within 2 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Zyrtec 10mg po daily - seasonal allergies Lexapro 20mg po daily,None,Celiac Disease,,No.,"['Chills', 'Electrocardiogram normal', 'Headache', 'Lip swelling', 'Palpitations', 'Swelling face', 'Throat tightness']",1,MODERNA,IM 925773,IA,58.0,F,"The following morning after patient received the vaccine, she developed a severe headache and sensitivity, dizziness, weakness and fatigue, body aches, and developed an elevated temperature with a temp of 100.7*F. She also described herself as having ""brain fog"". She reports these were all of the same symptoms she experienced in October when she was previously positive with COVID19.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,None,Previously lab confirmed COVID19 positive on 10/12/20,"Chronic arthritis to bilateral knees, history of asthma",,Tramadol- causes GI upset,"['Asthenia', 'Body temperature increased', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Headache', 'Pain']",1,MODERNA,IM 925774,AL,55.0,F,"edema of eyelids, SOB",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,none,none,none,,none,"['Dyspnoea', 'Eyelid oedema']",2,PFIZER\BIONTECH,IM 925775,VT,44.0,F,"BP 140/100 HR 90 RR 18 O2 99 Temp 97.8 Sudden onset of Left arm pain, rash, redness 5 minutes after infection. No respiratory distress or worsening symptoms. Stayed and observed for 30 minutes and then released",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Erythema', 'Pain in extremity', 'Rash']",UNK,MODERNA, 925776,OH,44.0,F,Patient had swelling at the injection site and all down her arm and hand. The swelling was painful and she could not get her wedding ring on her fingers.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"multivitamin, olive leaf, oregano, Wellbutrin, Welchol, Synthroid",None,,,"Avelox, Cherries","['Injection site swelling', 'Pain', 'Peripheral swelling']",1,MODERNA,IM 925777,MI,39.0,F,"Felt sharp pain under jaw, then facial numbness. Then quickly developed facial swelling, left eye swelling and tongue swelling. Then felt like throat closing up within 7 minutes of receiving vaccine. Received vaccine in the clinic, was transported to Emergency Room. In ER received Epinephrine, steroids, Benadryl and Pepcid.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,None,"None, just tree nut allergy with history of anaphylaxis to tree nut last episode 2011.",,Tree Nuts,"['Anion gap', 'Blood calcium decreased', 'Blood chloride increased', 'Blood creatinine normal', 'Blood glucose increased', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea normal', 'Carbon dioxide decreased', 'Eye swelling', 'Haematocrit normal', 'Haemoglobin normal', 'Hypoaesthesia', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Pain in jaw', 'Platelet count normal', 'Red blood cell count normal', 'Red cell distribution width normal', 'SARS-CoV-2 test negative', 'Swelling face', 'Swollen tongue', 'Throat tightness', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 925779,WA,55.0,F,"Patient initially experienced headache, body aches, arm pain, and swelling under the armpits. Patient managed symptoms with ice packs. Symptoms have resolved as of 1/6/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,NKDA,"['Headache', 'Oedema peripheral', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 925780,UT,38.0,F,"Within 5 minutes of vaccination patient began to experience tachycardia and throat tightening. She was given 25 mg cap Benadryl PO and assistance was called when her heart rate reached 150 BPM about a minute later and further climbed to 188 BPM. She was transported to the Emergency Department where she was administered epinephrine, lorazepam, methylprednisolone, racepinephrine, and lactated ringers. She spent several hours in the Emergency Department and was discharged home but returned later that night at 06:00 PM for return of symptoms (tachycardia: 185 BPM, anxiety) and was administered Benadryl, solumedrol, Pepcid, Ativan, and Lactated Ringers. She was diagnosed with acute allergic reaction, nascent anaphylaxis, and panic attack. She went home again after this second ED visit. On Monday, 1/4/21, the patient reported to Employee Health with resumption of symptoms. Calming techniques were discussed and she went to a quiet area for 15 minutes to compose herself. Employee Health Nurse referred patient to Employee Assistance Program for anxiety care.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Alprazolam 0.25 mg tab PO daily PRN Ketoconazole 1% topical shampoo topical application once Q3D Medrol Dosepak 4 mg tab Rizatriptan 10 mg tab PO daily Zyrtec-D 5 mg-120 mg tab extended release PO BID,UNKNOWN,"Obesity, panic attacks, seborrheic dermatitis of scalp",,NSAIDS,"['Anaphylactic reaction', 'Anxiety', 'Chest X-ray normal', 'Condition aggravated', 'Electrocardiogram P wave abnormal', 'Electrocardiogram QRS complex normal', 'Electrocardiogram QT prolonged', 'Fibrin D dimer normal', 'Heart rate increased', 'Hypersensitivity', 'Panic attack', 'Sinus tachycardia', 'Tachycardia', 'Throat tightness', 'Troponin normal']",1,PFIZER\BIONTECH,IM 925781,NY,27.0,F,"chills/sweats, head ache, body ache, joint pain, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Effexor 150mg,,Anxiety,,Shellfish,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Pain']",2,PFIZER\BIONTECH,IM 925782,NE,99.0,F,"DEVELOPED FATIGUE,SHAKINESS, AND NAUSEA.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,,,,,,"['Fatigue', 'Nausea', 'Tremor']",1,PFIZER\BIONTECH,IM 925783,MD,44.0,F,supraclavicular enlarged lymph node- painful to palpation,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,"Synthroid, Vitamin D",,"Hypothyroidism, Endometriosis",,,"['Lymphadenopathy', 'Pain']",UNK,MODERNA,IM 925784,KS,33.0,F,"Redness, pain, swelling, warmth at the injection site- starting 1/7/20",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,OTH,Doxycycline 100 mg every other day for 1-2 more weeks Aczone- daily Amzeeq-daily Tretinoin .1%- daily Juice Plus- daily VitalBiome by Plexus- daily ProBio5 by Plexus- daily,None,None,,Latex,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 925785,FL,61.0,F,"coughing, fever, headache, nausea, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,"rosuvastatin 20mg, escitalopram 10mg, zyrtec, nexium, biotin 1,000mcg, centrum",,,,,"['Cough', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia']",1,MODERNA, 925786,MN,86.0,F,"Nausea, fatigue hit suddenly the next morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,SEN,Na,None,lymphedema,,Brevibloc,"['Fatigue', 'Nausea']",1,MODERNA,IM 925787,OH,38.0,F,"1/6/2021- Fever, headache 1/7/2021- diarrhea, headache, sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"Prilosec 40 MG, Metformin 500MG, Wellbutrin 150 MG, Probiotic 50 billion",,"GERD, Back pain",,"Nexium, Nitrile","['Diarrhoea', 'Headache', 'Oropharyngeal pain', 'Pyrexia']",1,MODERNA,IM 925788,TX,74.0,M,"Patient report headache, body aches and fatigue 2 hours post vaccine. Home remedies include Ibuprofen on 01/06/21 and two doses of Ibuprofen this morning 01/07/21. Patient remains working. He reports no improvement in symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 925789,VT,45.0,F,"Began to develop ?tickle in throat? 8 minutes after injection, no rash, no respiratory distress, VS stable. Observed for 30 minutes and then released. Symptoms resolved with Benadryl. 25 mg of Benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,,['Throat irritation'],UNK,MODERNA, 925790,IN,28.0,F,"Arm soreness, fever (101.5F), chills, rigors, headache, and body aches. The fever and chills were refractory to ibuprofen and required both ibuprofen and Tylenol to break. The fever and chills continued for 24 hours and the headache/body aches continued for 36 hours, the arm soreness has improved but is ongoing.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,UNK,Synthroid,None,"Hypothyroidism, obesity",,Ephedrine,"['Chills', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925791,NM,39.0,F,Perioral numbness & mild edema.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,None,,,,"Bactrim, Strawberries","['Hypoaesthesia oral', 'Oedema']",2,PFIZER\BIONTECH,IM 925792,ME,63.0,F,"Fatigue, in 7th day, left arm felt heavy, tingling, upper arm injection site had redness, a large bump with small lumps inside. Went to see Dr. marked it...Said apply topical benadryl and ice it (I did not have topical benedry). Next day it was redder, warm to the touch and had spread. Went to see another provider and out me on antibiotic. Allergic reaction and cellulitis.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,WRK,Vitamin D once a week,No,No,,"Carrots, corn, bakers yeast, Candida yeast, coffee","['Cellulitis', 'Fatigue', 'Hypersensitivity', 'Injection site erythema', 'Injection site mass', 'Injection site swelling', 'Injection site warmth', 'Limb discomfort', 'Paraesthesia']",UNK,MODERNA,IM 925793,MN,36.0,F,"Immediately after injection, I felt a warm feeling flow from the injection site and across my chest. No shortness of breath or chest pain. Felt slightly light-headed. Drank water and ate some food to closely monitor. Very sore Left deltoid starting about 8 PM on 12/31/20 (same day as the vaccine administration). It was so sore that it woke me up a few times at night and 1/1/21 I had to take Ibuprofen 400 mg to alleviate the pain. Had a dull headache all day 1/1/21 and very tired. Slept that night from 9 pm - 8 am next day. No symptoms since 1/3/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Norethindrone once daily, Zyrtec 10 mg once daily, 1000 mg Vitamin C daily, Magnesium 250 mg daily. Albuterol inhaler 1-2 puffs as needed PRN, Epi-Pen as Needed for anaphylaxis. Ibuprofen/Tylenol as needed for pain.",None,"Asthma, Hepatitis B, Chronic back and left knee pain, Plantar Fasciitis, Depression, Anxiety",,"Tree Nuts, fresh apples/peaches/pears/plums, shrimp, cat & dog dander, seasonal allergies. Gluten intolerance.","['Dizziness', 'Fatigue', 'Feeling hot', 'Headache', 'Immediate post-injection reaction', 'Injection site pain', 'Injection site reaction', 'Sleep disorder']",1,PFIZER\BIONTECH,IM 925794,OH,28.0,F,"Diminished lung capacity with SOB and slight cough upon exhalations, intermittent. Started day of vaccination and continues.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,UNK,Synthroid Birth Control Daily Vitamin,,Hashimoto?s,,,"['Cough', 'Dyspnoea', 'SARS-CoV-2 test negative']",1,MODERNA,IM 925795,TX,49.0,F,"Fever, chills, feet felt frozen-Sat day & evening w/ABD pain Exhausted-she slept, next day Sunday@02 or 03 sleeping clothes all wet-she had to change her clothes, Sunday-she feels drained, She laid in bed Saturday & Sunday drank water and took Motrin. Monday-too weak to work. Body aches, headache. Monday severe ABD cramps-heating pad to help/nauseated. Tuesday diarrhea starts. Wednesday-left side of her back-pain-diarrhea & Tired. No SOB. Drinking Pedialyte and taking Motrin-she said IF she gets worse she will go to the Urgent Care-near her home.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,MIL,vitamins,2 weeks ago-ear infection,none,,none noted,"['Abdominal pain', 'Asthenia', 'Back pain', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Peripheral coldness', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 925796,WI,40.0,F,"RN received her first dose of the Moderna Covid Vaccine on 1/6/2021 at approximately 0615 at hospital. Within 5-10 minutes patient noted that her heart was racing and pounding in her chest. Hospital RN went and assessed patient- color pale, heart pounding. HR-157, B/P-135/105, O2 sats-100%. 0630-Ambulated with patient to ED area and sitting in recliner. C/O of dizziness, chills and heart continues to race. HR-148, B/P-150/83, O2 sat-100%. Patient given warm blankets. Patient had not eaten yet this morning so was given apple juice and cracker. Tolerated well. Patient states her mouth is tingly and is very dry. Drinking fluids with out problem. 0640-Feeling better, chills- given warm blankets. HR-105-110, B/P-113/71, O2 sats-100%. 0700-Spoke with ED physician-plan to observe for 1 hour if no improvement will evaluate further in ED. Patient denies any swelling, itching, difficulty breathing. HR-104, B/P-121/79, O2 sats-100%. 0715-Patient is experiencing waves of chills, dizziness and then feeling better. HR-97, B/P-118/78, O2 sats-100%. 0730-Patient continues to feel better but has waves of dizziness and chills. HR-90's, B/P-118/70, O2 sat-100%. Patient was able to tolerate walking to BR without problems. Patient has opted to go the Health Clinic for further evaluation. Family is coming to pick up Patient following this. Patient hasw been instructed to register for V-safe, complete the Covid Intake form and call the Covid Hotline. Patient tolerated walking to the clinic without issue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Chills', 'Dizziness', 'Dry mouth', 'Electrocardiogram', 'Pallor', 'Palpitations', 'Paraesthesia oral']",1,MODERNA,IM 925797,IN,48.0,M,"Fever, exhaustion back pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"Asprin , Toprol, fiber supplement","Felt bad, negative Covid tests, mild bronchitis. No fever or coughing 2 weeks prior",HBP,"Unknown , very sick with a fever for a couple of hours",,"['Back pain', 'Fatigue', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 925798,,61.0,F,"Headaches, body aches, chills, x 3 days now resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/1988,12/30/1988,0.0,SEN,,,,,,"['Chills', 'Headache', 'Pain']",1,PFIZER\BIONTECH,IM 925799,MO,34.0,F,"Injection site reaction, hot to touch, pain and tenderness, redness, swelling to size of half dollar Pain lasted approximately 24 hours. Swelling, redness, and heat lasted approximately 30 hours Ice pack to site frequently, Tylenol and ibuprofen twice",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,"Zyrtec, birth control Drospirenone/Ethy EST, Vyvanse, Lexapro, Buspar",none,"generalized anxiety, binge-eating disorder",,,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 925800,TX,71.0,F,Headache began morning after vaccine was received. Improves with tylenol. Still having intermittent headaches. Has followed up with her PCP.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/18/2020,1.0,WRK,,,,,,['Headache'],1,PFIZER\BIONTECH,IM 925801,CT,62.0,M,"Fever 102.1, bone, joint, muscle pain, chills, headache, malaise, sore arms lasted 24 hours, took Tylenol, which cut fever and made me feel a little better, and the next day I felt normal again. I had no reaction to 1st dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Synthroid Nasonex, vitamins",none,none,,no,"['Arthralgia', 'Bone pain', 'Chills', 'Headache', 'Malaise', 'Myalgia', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925802,TX,53.0,M,"bad headache, nausea and vomiting, chills, dizziness, fatigue, weak , 102 fever. Took Tyelonol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,stage 3 kidney failure,,,"['Asthenia', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",UNK,MODERNA,IM 925803,CA,51.0,F,"1 wk after administration: Redness, swelling, warm/hot to touch, tender to touch, very mild itching Seen in ER treated for cellulitis/rash Sent home with 7 days course of antibiotics and antihistamines. Improvements seen after 1 full day of antibiotics.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/02/2021,7.0,PVT,Ferrous sulfate 325 mg Vitamin B12 500 mcg Vitamin B-6 100 mg Ibuprofen 600 mg,None,Migraine Mild sleep apnea Premenstrual Dysphoric Disorder,,Lidocaine,"['Erythema', 'Pruritus', 'Skin warm', 'Swelling', 'Tenderness']",1,MODERNA, 925804,GA,29.0,F,SORE RIGHT ARM. INJECTION SITE SWELLING,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/01/2021,,PUB,,,,,SEAFOOD,"['Injection site swelling', 'Pain in extremity']",1,MODERNA,IM 925805,MO,28.0,F,"01/05/21: nausea 01/06/21: nausea and headache 01/07/21:nausea, head ache, muscle/joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,UNK,"omeprazole, proair, loratadine, ibuprofen",none,"asthma, adhd, ptsd, anxiety",,"sulfa, penicillin, codeine","['Arthralgia', 'Headache', 'Myalgia', 'Nausea', 'SARS-CoV-2 test negative']",1,MODERNA,IM 925807,CT,37.0,M,"The afternoon post vaccination I developed injection site soreness and fatigue. That evening about 13 hours later I develops chills, rigors, fever, myalgia, light headedness, headaches, palpitations, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Levemir, metformin, losartan, fish oil, B12, Vitamin D",,"Hypertension, diabetes",,Shellfish,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Palpitations', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925808,CA,46.0,F,"Chills, fever, extreme body aches, nausea Ibuprofen 400mg taken every 4-6 hours. Fever broke after 15 hours but returned within 4-6 hours. Easier to manage on second day with ibuprofen. Loss of appetite and nausea. Compazine taken forever nausea. Currently 50 hours post vaccination, had to miss work due to symptoms. Fever free for 12 hours , co tinge to have loss of appetite and body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Vit D Fish oil Singulair B complex,,Asthma,,Sulfa Pepcid,"['Chills', 'Decreased appetite', 'Impaired work ability', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925809,NY,59.0,F,"Soreness at the injection site, headache, fatigue. The soreness appeared first, then the rest appeared about 6 hours later",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Vitamin D,None,"Rosacea, hay fever/dust mites, vertigo","Soreness at injection site, flu shot",None,"['Fatigue', 'Headache', 'Injection site pain']",UNK,MODERNA,SYR 925810,GA,42.0,F,"The first 2 days after my shot I had a very sore arm, but no redness or swelling. After 2 days, the pain went away. One week later my arm started to hurt again and became red and swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,PVT,Vitamin D,Cold? Tested negative for Covid. Symptoms were headache and nasal congestion/post nasal drip.,None,,Penicillin (hives) Nickel,"['Erythema', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 925811,IL,65.0,F,"Moderna COVID-19 Vaccine EUA first dose. fever, chills, body aches, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,Losartan 100 mg daily Vitamin D3 2000 IU daily Multivitamin daily,NONE,Hypertension,,NONE,"['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,MODERNA, 925812,CT,24.0,F,"15 Minutes after injection: facial numbness on left side, neck, jaw and ear pain, Rash from face to legs. 24 Hours After: Muscle Tension, headache, light headed, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,"Beyaz, Vyvanse, adderall",,,,,"['Chills', 'Dizziness', 'Ear pain', 'Headache', 'Hypoaesthesia', 'Muscle tightness', 'Neck pain', 'Pain in jaw', 'Rash']",1,MODERNA,SYR 925813,CO,49.0,F,"Fever, chills, shaky",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,,,,,,"['Chills', 'Pyrexia', 'Tremor']",2,PFIZER\BIONTECH,IM 925814,CA,30.0,M,"Patient stated he was ""feeling flushed"", observed flushed cheeks, itchy lips, tingling tongue. Had him sit for vital signs, after a few minutes employee asked if he wanted fresh air and he felt fine enough to walk, she escorted him outside. They came back in after a few minutes and he sat down and drank some water. They retook vital signs and he said he was feeling better. 0742 vital signs 121/79, 02 sat 99, HR 87. 0757 vital signs 119/79, O2- 98, HR 77. Took Benadryl 1 hour after reaction and improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,n/a.,Sinusitis,Anxiety,,Zofran,"['Flushing', 'Lip pruritus', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 925815,VA,57.0,F,"I felt achy 24 hours after the exam but after 72 hours started feeling worse and developed a fever which progressed to a head cold and further progression to full Upper Respiratory infection, viral in nature. 168 hours later, lost sense of taste and smell and had some GI discomfort.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,WRK,"Atorvastatin 20mg daily multivitamin, calcium, fish oil",None,None,,NKA,"['Abdominal discomfort', 'Ageusia', 'Anosmia', 'Nasopharyngitis', 'Pain', 'Pyrexia', 'Viral upper respiratory tract infection']",1,PFIZER\BIONTECH,IM 925816,NV,47.0,M,"Monday morning I woke up with itchy red hives in several parts of my body, Tuesday morning since the symptoms were not any better (legs, torso) I decided to go to the walk in clinic at work and they suggested me to take some OTC Benadryl and it did work the same day and the rest of the day. The next day around lunch time the hives came back again I had a very red and tingling area around my neck and in my head. I returned to the walk in clinic and they gave me shot of Benadryl and prednisone and another drug I do not remember.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/21/2020,3.0,PVT,"Lisinopril and simvastatin, insulin (Novolog)",no,Type 1 diabetic,,No,"['Erythema', 'Paraesthesia', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,SYR 925818,WA,37.0,F,"Approximately 20 minutes after the first (and second) vaccine, I experienced numbness on my left side. Both times I was vaccinated in my left arm. The first shot I experienced numbness to my left face, neck, ear and eventually my left arm and leg. I had no trouble with movement, the sensation felt dull. There was no associated pain. Numbness resolved completely after 2 days. The second shot, I again about 20 minutes following experienced numbness to my left face and ear. This time it resolved after a few hours. Also, two days following the first shot, I experienced severe nerve pain in my low neck/ upper back radiating down my right arm. As I do not remember injuring it, I am unsure if this is related to the vaccine or not. It has lessened in severity over time but is still present 3 weeks later.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/16/2020,0.0,UNK,"Zoloft, Vitamin D",None,Crohns disease,,Doxycycline,"['Hypoaesthesia', 'Neuralgia', 'Pain']",1,PFIZER\BIONTECH,IM 925819,IL,59.0,F,""" by 8pm that night, i had nausea, body aches, back pain, diarrhea and arm pain. Except for the arm pain, symptoms lasted 24 hours. The arm pain lasted from 12/28/20 to 1/2/21""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,Chlorhexidine,"['Back pain', 'Diarrhoea', 'Nausea', 'Pain', 'Pain in extremity']",1,MODERNA,IM 925820,DE,64.0,U,"Right Deltoid 5cm X 5cm area is red and warm to touch. Hard induration, slight swelling. No fevers, cough, fatigue, muscle aches, Itching at site, rash or respiratory issues. No GI issues or loss of appetite. No relief from cold compress",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/01/2021,2.0,UNK,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 925822,TX,40.0,F,"On January 01, 2021 this 40-year-old female the patient reported pain at the injection site, patient was then treated with Tylenol 650 mg. On January 02, 2021 the patient continued to complain of pain on her right arm, site was warm to touch, with a red appearance. The patient was then treated with Tylenol 650 mg, and Benadryl 50 mg once. That same day the provider accessed the patients reported events and ordered ice pack placement, and Tylenol as needed for pain. On January 07, 2021 I spoke with the provider to follow-up on this ADR; the provider confirmed that the patients' events had resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 925823,,38.0,F,"Itchiness on right side of body, Mild headache, running nose and moderate soreness around injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/07/2021,2.0,UNK,,,,,,"['Headache', 'Injection site pain', 'Pruritus', 'Rhinorrhoea']",1,PFIZER\BIONTECH,SYR 925824,NC,57.0,F,Migraine red Spots all over Itchy Tired Generally feel bad Tired Chills and pouring sweat Joint pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,MIL,Synthroid Los art an HCTZ Vicodin Meloxicam Vyvanse Quetipine Ropinerole Cyrtizine Multivitamin D3 E Super C,None,thyroid HBP Pain Bipolar 1 COPD,,erythromycin Tramadol,"['Arthralgia', 'Chills', 'Fatigue', 'Feeling abnormal', 'Hyperhidrosis', 'Migraine', 'Pruritus', 'Rash']",1,MODERNA,IM 925825,TX,59.0,F,"Dizziness, Headache, Pain in joints,chills, Pain at site, swollen and red",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PUB,Celexa 40 mg and HCTZ 25 mg,Covid 19,"HTN, anxiety",,Tramadol,"['Arthralgia', 'Chills', 'Dizziness', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 925826,,35.0,F,Numbness in right arm. Loss of feeling in fingers x 3 days. Following up with PCP.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,SEN,,,,,,"['Hypoaesthesia', 'Sensory loss']",1,PFIZER\BIONTECH,IM 925828,UT,56.0,F,left leg / left arm -- numbness / tingling / cold / severe headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,none,none,none,,none,"['Feeling cold', 'Headache', 'Hypoaesthesia', 'Laboratory test', 'Magnetic resonance imaging', 'Paraesthesia']",UNK,MODERNA, 925830,MO,26.0,F,"Burning at injection site - Start: 5 mins after injection, End: 7 mins after injection Sore arm - Start: 2 hrs after injection, End: Evening of 1/6/21 Night sweats - Night of 1/4/21 (moderate-severe), Night of 1/5/21 (mild)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Bupropion XL 300 mg PO QHS Cetirizine 10 mg PO QAM Multivitamin PO QAM,None,Asthma,,Eggs - yolk and whites Shrimp Iodine Morphine Oxycodone Hydrocodone,"['Injection site pain', 'Night sweats', 'Pain in extremity']",1,MODERNA,IM 925831,CA,56.0,F,"Fever, body aches, and body rash on Day 2",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,Triamterene 25 mg QD,No,No,,No,"['Pain', 'Pyrexia', 'Rash']",2,PFIZER\BIONTECH,SYR 925832,TX,25.0,F,EE reported muscle aches that started on 01/6/2020 at 9: 00 AM. Muscles aches completely resolved without the use of medication. She reports feeling fine no other complaints.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,,,,,,['Myalgia'],2,PFIZER\BIONTECH,IM 925833,NY,63.0,M,"Patient was monitored for 1 hour after receiving his vaccine as requested by his primary care provider due to history of reaction to a previous vaccine. Patient monitored by EMS provider x 1hr, no s/s adverse reaction. Patient started walking out of facility on his own and came back reporting he felt dizzy. He was initially hypertensive with a pulse of 70, respiratory rate 12, systolic BP 188. We had him lay down and about 10 minutes later his blood pressure was 140/70. After another 10 minutes or so we had him sit and drink water but his dizziness, while improved, did not go away and he started to have chills and was visibly shaking so 911 was called as we did not feel he could drive himself home. Patient was monitored in the emergency department at Hospital x 1hr and released with blood pressure WNL.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,Symbicort,None,Asthma,"HDCV Pre-exposure Rabies Vaccine, patient age ~40 years","Penicillin. History of previous reaction to HDCV Pre-exposure rabies vaccine in 1998, experiencing fever and nausea after dose 1, and temporary blindness (15min) after dose 2. No other doses of HDCV pre-exposure rabies vaccine were given after 2nd dose.","['Chills', 'Dizziness', 'Hypertension', 'Tremor']",1,MODERNA,IM 925834,KY,54.0,M,Facial drooping No treatment Symptoms have improved but not completely resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,PVT,"Atenolol, Fenofibrate",None,HTN; Hyperlipidemia,,NONE,['Facial paralysis'],1,MODERNA,IM 925835,OH,37.0,F,"VOICEMAIL MESSAGE LEFT BY CLIENT- UNABLE TO REACH MY PHONE CURRENTLY - THIS INFO GIVEN-CLIENT STATES 72+ HOURS POST VACCINE, LEFT DELTOID AT INJECTION SITE WARM, RED AND TENDER, WHICH IS INCREASING . PURITTIS NOTED. ALSO LEFT SIDED LYMPHADENOPATHY , NO PARTICULAR SITE NOTED. NO OTHER SYMPTOMOLOGY VOICED.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PUB,UNKNOWN,NONE,UNKNOWN,,UNKNOWN,"['Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Lymphadenopathy']",1,MODERNA,IM 925836,TX,37.0,F,"Woke up in the morning on Wednesday 01/06/2021 with nausea and injection site arm pain that I could barely left my arm up. Around noon I started to feel hot with chills (I took a Tylenol). Around 3:30 pm I started to feel hot again, I took my temperature and I was at 100 F. I then took ibuprofen. I started to feel some fatigue, chills, and lower back pain around 4:30 pm and went home from work. I went home and fell asleep until 7 pm. The nausea was constant throughout the whole day. After 7 pm most of my symptoms subsided except the back pain. The back pain and arm pain improved next morning Thursday 01/07/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Birth Control: Enskyce once a day,none,none,,none,"['Back pain', 'Body temperature increased', 'Chills', 'Fatigue', 'Feeling hot', 'Injected limb mobility decreased', 'Injection site pain', 'Nausea', 'Pain in extremity']",1,MODERNA,IM 925837,NH,58.0,F,"Developed symptoms 1 week after injection. Red, raised area on arm, size of a quarter.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,PVT,,,,,,"['Erythema', 'Peripheral swelling']",1,MODERNA,IM 925838,,60.0,F,"Fatigue, body aches, headache x 1 day now resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,,"['Fatigue', 'Headache', 'Pain']",1,PFIZER\BIONTECH,IM 925839,OH,39.0,F,"12/31/2020 @ 0700- Client awoke with stuffy nose and ""did not feel right"". 1/3/2021- Starting in AM: Headache and fatigue that are continuous. Taking Tylenol, Excedrin, and Advil PM. 1/7/2021- Advised client to get Covid Testing and go to Urgent Care, as she has no PCP at this time. 1/7/2021 @ 1230- Client states has Covid test scheduled at 1430 today at Urgent Care.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PUB,Multi-vitamin and Depo-Provera,None,None,,Penicillin- Generalized swelling and hives,"['Fatigue', 'Feeling abnormal', 'Headache', 'Nasal congestion']",1,MODERNA,IM 925840,CA,41.0,F,"Itchy, rash, super hot, and swollen at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,UNK,,,,,,"['Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 925841,OH,44.0,F,"1/5/2021 Woke up with chills, body aches, fatigue, headache, GI cramping/upset, severe headache, pain at injection site that moved through neck/shoulder. Later in the day, began breaking out into sweats, headache worsened, very fatigued. Symptoms lasted over 48 hours. Had taken tylenol and slept and drank fluids throughout this time to help. 1/7/2021 Woke up feeling much better. Only symptom is pain at injection site. Called professional ouchline through employer to update due to missing 2 days of work on 1/6/2021 and 1/7/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,Levothyroxine Cabergoline Vit D Women's multivitamin,None,Hypothyroidism Prolactinoma,,None,"['Abdominal discomfort', 'Arthralgia', 'Chills', 'Fatigue', 'Gastrointestinal pain', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Neck pain', 'Pain']",1,MODERNA,SYR 925842,FL,48.0,F,Patient felt warm and dizzy and fainted twice during monitoring period.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Prozac,Unknown,Depression,,NKDA,"['Differential white blood cell count', 'Dizziness', 'Electrocardiogram', 'Feeling hot', 'Full blood count', 'Metabolic function test', 'Syncope', 'Troponin', 'Urine analysis']",1,MODERNA,IM 925843,WA,61.0,M,Very bad chills developed overnight approx Arm is very sore,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Pain in extremity']",1,MODERNA, 925844,WA,37.0,F,"37yoF presenting 8 days s/p left deltoid administration of her first dose of Moderna COVID vaccine with localized urticarial skin reaction about the injection site (1.5cm in diameter) with secondary site of urticarial skin eruption over the lateral arm approximately 10cm inferior to this which is approximately 5cm x 3cm. Denies any other symptoms associated with vaccine administration except localized arm soreness. No fevers, chills, night sweats. No prior diagnosed COVID infections. Not recently ill. Seasonal allergies historically, but no vaccine adverse effects. No anaphylactoid symptoms. No headaches, myalgias. Treatment with antihistamines and topical corticosteroids prescribed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,MIL,None,None,,,None,"['Injection site urticaria', 'Pain in extremity', 'Skin reaction']",1,MODERNA,IM 925845,AZ,35.0,F,"Relatively severe pain in joints (knees, ankles, shoulders) where there was none previously. Still ongoing as of today (01/07/2021). OTC anti-inflammatories taken with very little relief.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/28/2020,2.0,PVT,Humira Mirena MVI,none,Psoriasis,,none,['Arthralgia'],1,PFIZER\BIONTECH,IM 925846,PA,47.0,F,"Developed red area at injection site, hot to touch, itchy, burning, increasing in size",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 925847,,60.0,F,"Fatigue, body aches, headache x 1 day now resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,,"['Fatigue', 'Headache', 'Pain']",1,PFIZER\BIONTECH,IM 925848,TX,27.0,F,"Soreness from site of shot that radiated to most of my muscles and joints including shoulders, back, wrists, hips, and thighs. I also experienced nausea and a slight headache. I was unable to sleep because of my symptoms for at least 5 hours. I still am having some symptoms or aching as of 11:30am on 01/07/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,SCH,N/a,,,,Peanuts,"['Arthralgia', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Pain', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 925850,NJ,30.0,F,"After she got home she noticed she had headache, nausea, injection site was warm, hot, and itchy. 01/01/2021 she had ""usual"" side effects including headache, body aches, chills which subsided on their own. 01/02/2021 she started having heart palpations that later subsided on their own. 01/03/2021 heart was racing again, elevated HR up to 125 bpm measured by patient, plus dizziness; both of which again eventually subsided on their own. 01/04/2021 she had vomiting (30 min of constant fluid loss) and diarrhea (twice just prior to the vomiting). She called me (PCP) 01/05/2020 to discuss this reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Levothyroxine 75 mcg daily, liothyronine 5 mcg daily",None,Hashimoto's thyroiditis,,"Naproxen (hives), Sulfa drugs (hives)","['Blood thyroid stimulating hormone', 'Chills', 'Diarrhoea', 'Dizziness', 'Full blood count', 'Headache', 'Heart rate increased', 'Injection site pruritus', 'Injection site warmth', 'Metabolic function test', 'Nausea', 'Pain', 'Palpitations', 'Thyroxine free', 'Tri-iodothyronine free', 'Vomiting']",1,MODERNA,IM 925851,FL,72.0,M,Little red dots on torso,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/07/2021,2.0,OTH,"Amlodepine, vitamin B, folic acid and multi-vitamin",None,None,,Biaxin,['Skin discolouration'],UNK,MODERNA, 925852,IN,43.0,F,"Low grade fever, dizziness, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,None,None,None,,None,"['Dizziness', 'Fatigue', 'Pyrexia']",1,MODERNA,SYR 925853,IL,32.0,F,"""My arm was sore for the first 24 hours, but the next morning I noticed that my hands were red. Otherwise I just felt tired, and my skin felt hypersensitive""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,,,,,Sulfa antibiotics,"['Erythema', 'Fatigue', 'Pain in extremity', 'Sensitive skin']",1,PFIZER\BIONTECH,IM 925854,TX,58.0,F,"body aches, weakness, sore throat, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,metformin,,"high blood pressure, cholesterol, diabetes",,,"['Asthenia', 'Headache', 'Oropharyngeal pain', 'Pain']",1,PFIZER\BIONTECH,IM 925855,MN,81.0,M,"Starting on 1/2/2021 patient started experiencing intermittent tremors of upper /lower extremities that have been impacting on his mobility including transfers, ADLs and eating. Staff has now given the resident cups with lids to decrease spilling with meals. Provider was updated on resident's condition on 1/5/2021. On interview on 1/6/2021 resident stated he was feeling better, less tremor. Still felt unstable with transfers. Was able to eat and drink normally 1/6 and 1/7/2021. On exam on 1/6/2021 no tremor seen with rest or movement. In update from nursing staff 1/7/2021 no tremor noted, back to baseline. Had been on Losartan K 25 mg daily which was d/c'd 1/6/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/31/2020,01/02/2021,337.0,SEN,"APAP 650 mg daily, ASA 325 mg daily, Effexor 150 mg daily, Finasteride 5 mg daily, Metformin 1000 mg BID, Metoprolol 25 mg BID, Oscal/calcium carb/vit D 500/200 mg-units 1 tab BID, Pioglitazone HCl 45 mg daily, Pravastatin 40 mg daily","UTI, treated starting 12/7/2020 with 250 mg of Cipro BID x 7 days. Experienced physical decline after getting sick with UTI","diabetes, diabetic neuropathy, atrial fib, hypertensive kidney disease, age related decline, depression, BPH",,Nickel,"['Anion gap decreased', 'Blood calcium normal', 'Blood chloride decreased', 'Blood creatinine normal', 'Blood glucose normal', 'Blood potassium increased', 'Blood sodium decreased', 'Blood urea increased', 'Carbon dioxide normal', 'Feeling abnormal', 'Glomerular filtration rate normal', 'Glycosylated haemoglobin', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Tremor']",1,MODERNA,IM 925856,AR,50.0,F,"Pfizer BioNTech COVIS 19 Vaccine EUA developed body aches, chills, malaise, vomiting the morning after the vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,"HCTZ, Vitamin D",none,HTN,,None,"['Chills', 'Malaise', 'Pain', 'SARS-CoV-2 test', 'SARS-CoV-2 test negative', 'Vomiting']",2,PFIZER\BIONTECH,IM 925857,OR,42.0,F,"Wheezing, shortness of breath, macular itchy rash at site and distal sites, headache, fatigue and joint pain at 7-8 pm. Benadryl improved eruption, albuterol and airduo and assisting with wheezing but symptoms return after 2-4 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,Airduo Albuterol inhaler Flonase,N/a,Asthma Insomnia GERD,,Latex sensitivity,"['Arthralgia', 'Dyspnoea', 'Fatigue', 'Headache', 'Injection site rash', 'Rash macular', 'Rash pruritic', 'Wheezing']",1,MODERNA,IM 925858,MI,47.0,F,Itchiness and Hives all over body,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,Norethedrone,None,None,,Sulfa,"['Pruritus', 'Urticaria']",1,MODERNA, 925859,,50.0,F,"Fatigue, body aches, headache x 3 days now resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,SEN,,,,,,"['Fatigue', 'Headache', 'Pain']",1,PFIZER\BIONTECH,IM 925860,GA,66.0,F,"Patient complained of facial and lip tingling and numbness. Patient was A&O x 4, no abnormal breathing, V/S where: 1st attempt at 10:36AM: BP 180/98; P -100; RR-20, 2nd attempt at 10:40AM: BP 170/88; P-88; RR 20, 3rd attempt at 10:48AM : BP 168/88; P: 86; RR-18, and 4th attempt at 11:06AM: BP 120/78; P-80; RR-16. Patient received 25mg (12.5mg/5mL) of oral Benadryl at 10:45AM after initially refusing, reports decrease in the amount of tingling. Patient asked to stay for full hour of monitoring, patient refused stating that she felt better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,PCN,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia', 'Paraesthesia oral']",1,MODERNA,IM 925862,TX,42.0,F,"Patient stated 15 minutes post vaccination she felt tingling to her right hand for about 4 hours. Reports palpitations 30 minutes post vaccine. Unknown duration as per patient.. Patient denies any palpitations, chest pain, or shortness of breath at time of phone interview. At about 9pm on the day of vaccine patient reports a rash all over her body. Describes it as bumpy and very itchy, getting worse. Patient reports taking Benadryl. States it helped with the itching but rash is continuing to spread. Denies respiratory complaints at time of phone interview. Patient instructed to see her provider as soon as possible for evaluation and treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,MIL,Topamax Lasix 10m daily,,Intracranial Hypertension,,Demerol Sulfa medications Gut Sutures Derma bond Latex,"['Palpitations', 'Paraesthesia', 'Rash', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 925863,WA,37.0,F,"37yoF presenting today 8 days s/p left deltoid administration of her first dose of Moderna COVID vaccine with new localized skin reaction about the injection site (1.5cm in diameter) with secondary site of urticarial skin eruption over the lateral arm approximately 10cm inferior to this which is approximately 5cm x 3cm. Denies any other symptoms associated with vaccine administration except localized arm soreness. No fevers, chills, night sweats. No prior diagnosed COVID infections. Not recently ill. Seasonal allergies historically, but no vaccine adverse effects. No anaphylactoid symptoms. No headaches, myalgias. Antihistamines and topical corticosteroids prescribed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,MIL,None,None,None,,None,"['Injection site reaction', 'Skin reaction']",1,MODERNA, 925864,CA,37.0,F,"5 min after injection, pt developed L shoulder pain radiating to clavicle 4/10, now increasing to 6-7/10 and has decreased mobility of shoulder. sporadic burning sensation in arm between elbow and wrist.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,400mg gabapentin 200mg lamictal 200mg wellbutrin 75mg effexor.,,,,,"['Burning sensation', 'Injected limb mobility decreased', 'Injection site pain', 'Pain']",1,PFIZER\BIONTECH,IM 925865,OH,37.0,F,"PHONE MESSAGE RECEIVED WITH ENTERED INFO- UNABLE TO CONTACT X2. CLIENT IS HEALTHCARE PROVIDER. SYMPTOMS BEGAN 72HR+ POST VACCINATION. TENDERNESS, REDDNESS AND EDEMA AT INJECTION SITE. ""ITCHY"". THESE SYMPTOMS CONTINUE TODAY. ALSO NOTED L-SIDE LYMPHADENOPATHY- NOT SPECIFIC SITE",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PUB,UNKNOWN,NONE,UNKNOWN,,UNKNOWN- NO ANAPHALXIS TO ANYTHING,"['Injection site erythema', 'Injection site oedema', 'Injection site pain', 'Lymphadenopathy', 'Pruritus']",1,MODERNA,IM 925866,MA,57.0,F,"temp and chills began at 6pm(1/5/20) , starting at 99.9 and the highest was 101.2 lasted until 1/7/21 at 2AM-also had headache,body aches and nausea . on 1/7 at 7AM I noticed increase pain in my rt arm with a distinctive red area at the vaccine site approximately 3 inches around and swollen lymph nodes in the rt under arms. Had to call out of work for two days so far. I am covid recovered from 4/1/20",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,WRK,"Insulin,cozar,HCTZ,metformin",none,"type 2 diabetes,high blood pressure",,none,"['Body temperature increased', 'Chills', 'Headache', 'Injection site erythema', 'Lymphadenopathy', 'Nausea', 'Pain', 'Pain in extremity']",UNK,MODERNA,IM 925867,UT,36.0,F,"Pt reports numbness/tingling in hand and fingers on the right. Pt received 2nd dose of COVID-19 in right upper arm approximately 5 minutes prior to time of RRT. Observed pt from 1146 to 1205. Pt maintained stable vital signs throughout observation period, maintained a strong regular pulse ranging from 80 - 90 bpm. Maintained oxygen saturation on room air between 98-100%. At time of release, pt was still exhibiting numbness in fingers and palm of right hand. Good range of motion with right arm. Denies any symptoms other than the above stated. Provided pt of option to be seen in the emergency department, but pt declined, and stated that she would like to wait and if her symptoms persisted or worsened, she would come back to the ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,WRK,,,,,Metronidazole,"['Hypoaesthesia', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 925868,MO,63.0,M,"One week after the vaccination, sudden onset of severe itching at the site, with a raised red bump at site of needle puncture. The itching is severe, bad enough to prevent sleep, and there is redness around the injection site followed by burning pain. It has been a day since the itching started, and it has not let up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,OTH,None,None,None,,None,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Sleep disorder']",1,MODERNA,IM 925869,AR,50.0,F,"Pfizer BioNTech COVID 19 Vaccine EUA developed body aches, chills, malaise, vomiting the morning after the vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,"HCTZ, Vitamin D",none,HTN,,none,"['Chills', 'Malaise', 'Pain', 'SARS-CoV-2 test', 'SARS-CoV-2 test negative', 'Vomiting']",2,PFIZER\BIONTECH,IM 925870,NC,22.0,F,"Severity of symptoms: At their worst the symptoms were mild in the emergency department and the symptoms are unchanged. Pt is an employee here. Just received the Covid vaccine in the left arm. Shortly after vaccination she started to feel anxious with nausea. No vomiting, rash or swelling. No CP or SOB. Felt flushed without diaphoresis.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Vraylar, Celexa, Trazodone, Sprintec",None noted,Bipolar disorder; Depression; Asthma; Von Willebrand Disease,,"Latex, Natural Rubber","['Anxiety', 'Flushing', 'Nausea']",1,MODERNA,IM 925871,KY,52.0,F,"MY UPPER ARM/MUSCLE WHERE I GOT THE SHOT IS EXTREMELY SORE. IT IS STILL SORE I THOUGHT THE SORENESS WOULD GO AWAY . I CANT LIFT MY ARM LEVEL TO THE GROUND IT IS SO SORE I CANT HARDLY SLEEP ON IT , WAKES ME UP OUT OF A DEAD SLEEP, WHEN I PUT DEODORANT ON IT HURTS TO LIFT MY ARM TO THAT LEVEL. IT IS A STRUGGLE TO PUT MY ARM OVER MY HEAD.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,WRK,"ALENDRONATE 70 MG, LEVOTHYROXINE .075MG, VITAMIN D3, PANTOPRAZOLE 40MG, CALCIUM CITRATE D",,"HYPOTHYROIDISM, CELIACS DISEASE",,"EGG WHITE, PEANUTS, SOYBEAN, MILD, CLAM, SHRIMP, SALMON, WALNUTS, CHESTNUTS, CODFISH, SCALLP, WHEAT, CORN, SESAME SEED","['Injected limb mobility decreased', 'Injection site pain', 'Sleep disorder']",1,MODERNA,SYR 925872,,34.0,F,"Dizzy,hot,shaky and felt a brief shortness of breath. Continued to monitor. At discharge no further problems blood pressure 124/63 heart rate 97. Skin pink warm and dry. Respirations even and unlabored.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,"['Dizziness', 'Dyspnoea', 'Feeling hot', 'Tremor']",1,MODERNA,IM 925873,OH,47.0,F,"At 1 am the evening of her vaccination she awoke with fever of 102. fever lasted 3 days ranging from 100-102. Along with the fever she had sever headache, describing it as migraine and dizziness. on day 2 she developed diarrhea and localized reaction at injection site. inflamed, red, half way down to her elbow. complaining that lips have been tingly since onset of adverse reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PUB,"Metformin, Clonidine HCL, Fluoxetine HCL, Amlodipine","None, but recently recovered from COVID-19. resolution of symptoms was 12-16-20.","Hypertension, pre-diabetic, obesity",,None,"['Diarrhoea', 'Dizziness', 'Injection site erythema', 'Injection site inflammation', 'Local reaction', 'Migraine', 'Paraesthesia oral', 'Pyrexia']",1,MODERNA,IM 925874,WA,29.0,F,"~3 hours after injection: soreness at injection site After waking up the next morning: 101F fever, fatigue, muscle soreness, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 925875,IA,41.0,F,"STARTING ON 12/24/2020 I developed burning and itching in both feet and along both deltoids. This resulted in raised red pruritic wheals. I dosed Benadrly and used hydrocortisone cream to the area. Throughout the night, the rash appeared on both thighs, knees, back of the arms and along the back of the lower legs. Again raised pruritic wheals. It would improve with anti-histamine use. this continued until 12/29/2020. No persistent symptoms. There are no other changes in medicine, OTC medication use, no changes in foods/soaps etc.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/24/2020,3.0,PVT,Synthroid Calcitriol Calcium Vitamin D Yaz Spirolactone,none,Hypothyroidism (s/p total thyroidectomy and radioactive iodine secondary to papillary thyroid cancer at age of 14) Hypoparathyroidism (s/p total parathyroidectomy secondary to papillary thyroid cancer at age of 14),,none,"['Burning sensation', 'Hypothyroidism', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 925876,,64.0,F,"Fever, chills, body aches, headache, Fatigue, several days, now resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 925877,NY,32.0,F,"I had reduced taste no fever, no muscle aches no chills, no cough or shortness of breath. I decided to go to the ER to get a covid test because I was scheduled to work that day and I did want to make sure I was not positive due to the loss of taste but if I was not working that day I would not have got medical care. I did have loss of taste for some more days but after that it was resolved (around 3 days).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/26/2021,34.0,PVT,No,No,asthma,,No,"['Ageusia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,SYR 925878,NY,38.0,F,Arm pain at site where injected. Fever start nexted after noon with head and body aces,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Dietary supplement vitamins,None,RSD,,None,"['Headache', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,SYR 925879,,32.0,F,Hives & rash on the anterior/posterior neck,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/07/2021,10.0,WRK,,,,,,"['Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 925880,WA,43.0,F,"Hives of right side of body , lower and upper body .. Also in armpits... Sore arm after injection for a few days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/26/2020,7.0,PVT,None,celiac disease,None,,Penicillin,"['Pain in extremity', 'Skin test', 'Urticaria']",1,PFIZER\BIONTECH,IM 925881,IN,60.0,F,Severe Body aches cough fever 100.8 chills diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,None,,Rad,,None,"['Chills', 'Cough', 'Diarrhoea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 925882,WA,37.0,F,"4 days after injection: Soreness in arm, swollen and painful lymph node in armpit until evening of 1/6/21. 1/5/21 (1 week after injection), 5pm: swelling, redness, burning, hardened tissue around injection site on left shoulder. 1/6/21: Worsened swelling, redness, hardened tissue which continued to cover upper arm. Turned into hives (first time ever having that kind of allergic reaction). Took a Benedryl before bed. 1/7/21: symptoms improved by at least 50%. Much less pain in armpit. Redness and some tenderness still present in left shoulder. Another Benedryl taken this morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,UNK,Daily multi-vitamin,,,,Adverse reaction to Prednisone.,"['Axillary pain', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site urticaria', 'Lymph node pain', 'Lymphadenopathy', 'Pain in extremity']",1,MODERNA,IM 925883,SD,41.0,F,"Light headedness, skin flushing, syncope",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Unknown,,,,None,"['Dizziness', 'Flushing', 'Syncope']",2,PFIZER\BIONTECH,IM 925884,TX,68.0,F,Rash behind the ears. Applied Hydrocotizone and took Bendaryl,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PUB,None,None,None,,None,['Rash'],1,MODERNA,SYR 925885,GA,40.0,F,"Sensitive to temperature, chills , fever, sweats, headache, tx with tylenol, with no relief, 01/07/2021 faint headache only",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,"oestrin, Flonase, Xyzal, Propanolol",none,none,,seasonal allergies,"['Chills', 'Headache', 'Hyperhidrosis', 'Pyrexia', 'Temperature intolerance']",1,PFIZER\BIONTECH,IM 925886,AZ,52.0,M,"Swollen under left armpit that irradiates to my arm, L+ right side of my chest and L+ neck side. It caused pain and discomfort since last night.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,multivitamins,none,none,,none,"['Discomfort', 'Oedema peripheral', 'Pain', 'Peripheral swelling', 'Swelling']",2,PFIZER\BIONTECH,IM 925887,,49.0,F,Received Pfizer lot EL1284 on 12-31-2020 in right arm. That night she developed a fever and her armpits swelled up that she was not able to put her arm down. It lasted several days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Oedema peripheral', 'Pyrexia']",1,PFIZER\BIONTECH,IM 925889,FL,61.0,F,"Pt c/o ""heaviness"" to left arm",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,,,,perfume/cologne,['Limb discomfort'],1,MODERNA,IM 925890,PA,33.0,M,"Tachycardia, elevated BP. Monitored patient and he felt better. Did recommend that he go to the ER for follow-up and escorted him there.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Adderall,rectal bleeding,,,Amoxicillin,"['Blood pressure increased', 'Blood thyroid stimulating hormone normal', 'Full blood count normal', 'Metabolic function test normal', 'Tachycardia', 'Thyroxine free normal']",1,PFIZER\BIONTECH,IM 925891,IN,49.0,F,"flushing, itching /burning of ears, tightness of throat, cough, generalized itching",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,"Wellbutrin, Buspirone, protonix, allegra, vit C, Vit B12, Vit D, iron",na,"anaphylactic allergies, asthma",,"Wheat, tree nuts, melons, strawberry, mango","['Cough', 'Ear discomfort', 'Flushing', 'Pruritus', 'Throat tightness']",UNK,MODERNA,IM 925892,CT,27.0,F,Patient received vaccination yesterday morning. About an hour after receiving became shaky and felt flushed. States feeling did resolve after approximately 15 minutes. Woke up this morning with red bumps on the face that resembled small hives she has had in the past from allergens. Patient reports she did use a new facemask last night as well. Spots have gone down over the course of the morning. She used cold towel and topical benadryl and that has helped a little bit. Patient appears well and in good overall health no fever nausea or vomiting. Pt has no further concerns at this time.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,MIL,denies,denies,denies,,PCN and sulfa - states severe (anaphylactic),"['Flushing', 'Rash', 'Rash erythematous', 'Tremor', 'Urticaria']",1,MODERNA,IM 925893,FL,70.0,F,"Was referred by Dr for evaluation of reaction to first COVID vaccine. First vaccine on 12/21/2020 Pfizer-BioNTech. Administered by her place of work. Vaccine was administered in left arm. Had same symptoms as when she had COVID in 10/2020 these symptoms lasted for 12 hours. Started the following day 24 hours after vaccine administration. Symptoms include injection site redness for 6 days, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, and overall feeling of un wellness lasting 12 hours. First symptoms was eyelid heaviness and weakness. No treatment, symptoms resolved on their own. Second vaccine due 1/11/2021. Was covid positive 10/2020- no appetite, aches, chills, sweating, weakness, heavy eyelids, fatigue, ongoing for 3 weeks. Has had difficulty in the past to flu vaccines with local injection site reactions. 09/2020 flu vaccine no symptoms. Has had pneumonia vaccine with no difficulties. Has not received shines vaccine yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,WRK,Amlodipine Besylate 5 MG Tablet 1 tablet Orally Once a day. Aspirin 81 81 MG Tablet Delayed Release 1 tablet Orally Once a day. Lisinopril 40 MG Tablet 1 tablet Orally Once a day. Metoprolol Tartrate 50 MG Tablet 1 t,"Hypertension Heart disease Hypothyroid Breast cancer Thoracic aortic aneurysm, without rupture",,FLU LOCAL,Demerol Percocet,"['Arthralgia', 'Asthenia', 'Chills', 'Discomfort', 'Fatigue', 'Headache', 'Injection site erythema', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,IM 925894,,39.0,F,"Body aches, chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,,"['Chills', 'Fatigue', 'Pain']",1,PFIZER\BIONTECH,IM 925895,NY,34.0,F,"Sore arm, body aches after day 2 of getting vaccinated, which was to be expected. I was concerned about last night on 1/6/21, where my L arm became extremely itchy, swollen and broke out in hives. Today, remains extremely itchy, swollen/raised and there is a red square over the injection site. The area of redness and swelling measures to be 3 inches by 3 1/2 inches and does not appear to be getting any larger as the day goes on. I did take 12.5 mg of benadryl, which has resolved some of the itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,PVT,25 mg metoprolol HS Sprintec birth control HS,None,None,,Seasonal allergies in spring/summer,"['Injection site erythema', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Urticaria']",1,MODERNA,IM 925896,WA,39.0,F,bruising redness itching hives headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,WRK,Amoxicillin Multivitamin,Streptococcus (throat),None,,Adverse reaction to bee stings,"['Contusion', 'Erythema', 'Headache', 'Pruritus', 'Urticaria']",1,MODERNA,IM 925897,OH,42.0,F,"Patient received the vaccine 12/30/20, her reaction began 1 week later on 1/6/21 in the afternoon. Patient developed an itchy, red knot at injection site; 2 inches in diameter and warm to the touch. Patient still has the knot on her arm at the time I am reporting this. She has not taken any medication for it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"Requip, Omeprazole",,,,Penicillin,"['Injection site erythema', 'Injection site nodule', 'Injection site pruritus', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 925899,IN,34.0,M,Injection site soreness Fever lasting ~12 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,PVT,Meloxicam (MOBIC) 15 mg once a day for shoulder pain,No,No,,No,"['Injection site pain', 'Pyrexia']",1,MODERNA,IM 925900,,25.0,F,"Persistent headaches for more than 3 days, chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/03/2021,2.0,UNK,,,,,,"['Chills', 'Fatigue', 'Headache']",UNK,PFIZER\BIONTECH, 925901,NY,,U,"Shortly after receiving vaccine, felt warm/nausea. moderate soreness (L) arm. Also, numbness peri-orbital area and (L) cheek. Today 1-6-21, she has persistent intermittent nausea, warmth throughout Body (afebrile) + continues with numbness (L) side face maxillary (all) and part mandiBular Branch. No redness/swelling (L) arm, mod. discomfort",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,"Ibuprofen, Tylenol Both prn, Super B complex, Probiotic, CA + Mg","Previous Bell's Palsy, 2012 Removal meningioma",,,SeasonaL,"['Feeling hot', 'Hypoaesthesia', 'Limb discomfort', 'Nausea', 'Pain in extremity']",1,MODERNA,IM 925902,PA,41.0,F,Approximately 36 hours post 2nd dose of vaccine I experienced intermittent fever and severe chills (rigors) over a 6 hour period not relieved by ibuprofen; tmax 103. All symptoms resolved by the 48 hour post vaccine mark,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,WRK,"Vitamin D, albuterol",,asthma,,NKDA,"['Chills', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925903,FL,73.0,M,"Awakened from sound sleep in morning of January 6th (~8 days post vaccination) with intense pruritis (itching) of left shoulder and arm (injection site and bicep region). When I arose in the morning, I noticed a wide (approximately 3-inch band) of erythema (redness) extending from injection site in left shoulder and extending along outer aspect of bicep to about 2 inches above antecubital fossa (bend of elbow). I applied roll-on topical anesthetic (4% lidocaine) and 1% hydrocortisone cream, which diminished but did not completely eliminate the itching. Last night, I added OTC Benadryl 25 mg orally, 1 dose. Today, itching is less, but still present. On upper left arm and shoulder the erythema is slightly less, while redness is more intense, but sharply demarcated at the base of the bicep (about 1 inch above the elbow crease. Seems likely this is a delayed allergic reaction. Unless instructed otherwise, will likely not proceed with second dose of vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,OTH,"rosuvastatin 5 mg daily (before bed) Lumigan (bimatoprost) 0.01% ophthalmic solution 1 drop both eyes at bedtime, daily aspirin 81 mg 2 tabs twice a day Metformin 1000 mg daily Acetyl-L-Carnitine 500mg Twice daily",None,Dyslipidemia (well controlled),,"iodine contrast dye (urticaria, mild)","['Eosinophil count normal', 'Eosinophil percentage', 'Injection site erythema', 'Injection site pruritus', 'White blood cell count normal']",1,MODERNA,IM 925904,IN,33.0,F,"Fever, chills, body/joint aches, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Fluboxamine,None,None,,None,"['Arthralgia', 'Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,MODERNA,SYR 925906,KS,39.0,F,"Patient received her # 1 moderna on 12/30/2020. Eight days later on 01/07/21 she woke up and felt a ""bee sting sensation"". She looked at her arm and noticed below the injection site was a reddened area approx 2.5 inches long by 2.0 inches wide. The ""bee sting sensation"" has gone away shortly after noticing the reddened are and now is just tender to the touch. Encouraged patient to put Ice on the reddened area and or Tylenol or Ibuprofen if needed for pain or swelling. Patient will report back to me tomorrow. The health department will monitor this situation over the next couple of days. Encouraged patient to follow up with her primary care physician for worsening symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PUB,"Ginger, Magnesium, D3, Tumeric",None,None,,None,"['Feeling abnormal', 'Injection site erythema', 'Injection site pain']",1,MODERNA,IM 925907,,44.0,M,Nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,,['Nausea'],1,PFIZER\BIONTECH,IM 925908,NY,61.0,F,"6-8 minutes after the shot felt a sensation from left shoulder slowly sweeping across body, going into face and neck to the inside of left eye. Face had a weird feeling also. Headache, tonged tingling. Left and went to the car. Face was red and swollen all over. Skin looked like she was skiing in the middle of winter. She went back inside the hospital to her department on the 5th floor and stayed about 30 minutes. Then she went home. Half bottom lip was swollen, Both eyes got itchy, glassy, watery. Behind sinuses hurt really bad. Next day pain in hips both knees. Took 2 full days for the redness to go away from face. Had dark circles under eyes. Took Claritin. Hair has been shedding, sever brain fog at work. Her employer told her to take some time off from work . Upper teeth hurt.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,"Dexilant, lo grade steroid shot every 6months.",no,"GERD, asthma",,"chemical sensitivity to scented products, dust, mold cat dander","['Alopecia', 'Arthralgia', 'Dark circles under eyes', 'Erythema', 'Eye pruritus', 'Feeling abnormal', 'Glassy eyes', 'Headache', 'Lacrimation increased', 'Lip swelling', 'Pallor', 'Paraesthesia oral', 'Sinus pain', 'Swelling face', 'Toothache']",1,MODERNA,SYR 925909,AZ,44.0,M,"Had manageable bodyaches but following day triggered his Migraine headaches which is what patient came in for primarily. Symptoms managed with fluids, tylenol, reglan with improvement and was subsequently discharged from the ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,None,"prediabetes, obesity",,None,"['Basophil count decreased', 'Basophil percentage decreased', 'Eosinophil count decreased', 'Eosinophil percentage decreased', 'Haematocrit normal', 'Haemoglobin normal', 'Immunoglobulins decreased', 'Lymphocyte count decreased', 'Lymphocyte percentage increased', 'Mean cell haemoglobin concentration', 'Mean cell haemoglobin increased', 'Mean cell volume normal', 'Migraine', 'Monocyte count decreased', 'Monocyte percentage', 'Neutrophil count increased', 'Neutrophil percentage increased', 'Pain', 'Platelet count normal', 'Red blood cell count normal', 'Red cell distribution width normal', 'White blood cell count increased']",UNK,MODERNA,IM 925910,TN,33.0,F,"I have had extreme muscle pain and tightness in my left arm, shoulder and neck since 12-30-2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,Effexor Methimazole Buspar,None,None,,,"['Injection site pain', 'Injection site reaction', 'Muscle tightness', 'Myalgia']",1,PFIZER\BIONTECH,IM 925911,CA,29.0,F,"Patient received vaccine @ 1910. Patient sat in recovery area. Pt reported to RN that she was feeling faint and a bit of heaviness. Assisted patient to the floor with head supported with jacket in supine position with feet elevated. Patient did not faint. Obtained vitals 1914 BP: 103/68, HR: 67., o2: 97%. Patient denies being pregnant, but states that she has started a diet. Pt states eating yogurt prior to receiving the vaccine. Continued to monitor patient, no change in status. 1920 BP 129/75, HR: 80, o2: 98%. Patient states feeling better, asked to sit up, still on the floor. 1930 BP: 119/77, HR: 71, o2: 98%. Offered patient apple juice, pt able to tolerate PO liquids. 1940 patient assisted to sit up in chair BP: 134/89, HR: 72, o2: 100%. Patient continued to remain stable with improvement, no feeling of faint or heaviness. 1950 patient transitioned to standing position BP: 118, HR: 75 , o2: 95%. Pt walked around clinic to see if she could tolerate walking. Pt states having to drive home, asked if a ride was available, pt stated no. Pt states feeling fine to drive home. Pt discharge @ 2000 in stable condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Not known,Not known,not known,,Not known,"['Discomfort', 'Dizziness']",1,PFIZER\BIONTECH,IM 925912,ND,25.0,F,Cellulitis to injection site with swollen lymph nodes under that arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,SCH,,None,None,,None,"['Injection site cellulitis', 'Lymphadenopathy']",1,MODERNA,IM 925913,ME,44.0,F,"LEFT UPPER ARM REDNESS, HOT TO TOUCH AND BURNING SENSATION WITH ITCHING",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,PVT,"LEXAPRO, MACROBID",NONE,,,"SULFA, REGLAN","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 925914,MI,35.0,F,"I received my Moderna Covid vaccine around 7:30am on 12/29/2020. On 1/5/2021 at around 8:30pm, I noticed an itchy, erythematous, wheal just anterior to the injection site in the left deltoid. This evolved into hives in about an 8cm annular region on the left deltoid shortly after. The following day, there was an erythematous macular area on the left deltoid approximately 8cm in diameter consistent with a local injection site reaction. It is still present today on 1/7/2021 but is not worsening. I'm reporting because I am a PA and the lapse in onset of injection site reaction following injection seemed somewhat prolonged (7 days). I have no additional symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,"Prenatal vitamin, Zyrtec 10mg once a day, Rhinocort, Vitamin D3 5000 IU QD",none,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Injection site urticaria', 'Rash macular', 'Skin reaction']",1,MODERNA,IM 925915,NY,46.0,F,"about 20 minutes after receiving vaccine, lip tingling and feeling ?woozy? for the majority of the rest of day; headache, joint swelling/pain in back, neck, injection arm, including wrist with decreased ability to rotate which is still present on 01/06/2021;injection site soreness/throbbing - reports having many allergies and history of migraines",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Arthralgia', 'Back pain', 'Dizziness', 'Headache', 'Injection site pain', 'Joint range of motion decreased', 'Joint swelling', 'Neck pain', 'Pain', 'Pain in extremity', 'Paraesthesia oral']",UNK,MODERNA,IM 925916,KS,27.0,F,Vasovagal Syncope w/ orthostatic hypotension for ~5 hours following.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,UNK,Adderall,None,None,,NKDA,"['Orthostatic hypotension', 'Syncope']",1,MODERNA,IM 925917,NY,47.0,F,"Roughly 9 days after first vaccine, noticed your right hand middle finger became purple, with pins and needs sensation. This was followed by some swelling. Improved over 24 hours. Still feeling ""tight"" in knuckles.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/06/2021,9.0,PVT,"Levothyroxine, claritin, multivitamin, biotin",No,Hoshimoto disease,,,"['Joint stiffness', 'Paraesthesia', 'Skin discolouration', 'Swelling']",1,PFIZER\BIONTECH,IM 925918,IL,54.0,F,"pain/swelling at injection site (expected) worsening of regular joint pain in addition to new joint pain ocular migraines (had aura 3 or 4 times that next week, this is something I do not experience frequently, hadn't had one for at least 15 years prior to the vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/22/2020,4.0,PVT,"Levothyroxine, Metoprolol, Xanax, Lisinopril, Evening Primrose Oil, Vitamin D, Vitamin C",Psoriatic Arthritis (not on any meds for it currently) High Blood Pressure Hypothyroid (subsequent to radioactive iodine for Grave's disease),See Item 11,,"Kiwi fruit, Septra. I also have an adverse reaction to Epinephrine (severe headache and pass out, dentist realized it was the epinephrine and quit using it on me)","['Arthralgia', 'Condition aggravated', 'Injection site pain', 'Migraine with aura']",1,PFIZER\BIONTECH,IM 925919,FL,46.0,F,Lower lip twitching,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,01/01/2021,14.0,UNK,,,,,,['Muscle twitching'],UNK,PFIZER\BIONTECH, 925920,NY,62.0,F,On Day 5 after vaccination I woke up with pain under my left arm and noted large swollen lymph node (presumed lymph node),Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,PVT,"ASA, Isosorbide Mono Er, Amlodipine Besylate, Lipitor, MVI, Vit D3, Calcium, Magnesium, Vit C",none,"MI due to Cardiovasospasm, borderline ITP, PAI 1 deficiency (bleeding disorder), high cholesterol",,none,"['Axillary pain', 'Lymphadenopathy']",UNK,MODERNA,SC 925921,NY,55.0,M,Moderna COVID-19 Vaccine EUA Eczema flared-up unexpectedly in anterior left forearm and on radial side of wrist. Both flare-ups happen occasionally but neither had happened for over 12 months before vaccination.w,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/29/2020,3.0,PUB,None,None,"Occasional eczema flare-ups, chronic",,None,"['Condition aggravated', 'Eczema']",1,MODERNA,IM 925923,CA,28.0,F,"on the day of the vaccination 12/30/20, I experienced an allergic reaction on both of my feet. they both were swollen with red blothches. 1/6/21 I noticed that my arm was swollen and red, I have a big red blotch at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,none,none,none,,none,"['Injection site erythema', 'Peripheral swelling', 'Rash macular']",1,MODERNA,IM 925925,NY,52.0,M,1 day after the vaccine he had a low grade fever... 1 week later he had a seizure and then multiple ones in the ER...,Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,12/28/2020,01/04/2021,7.0,WRK,"Leviteracetam for seizures because he had a first time seizure after testing positive for COVID-19. Gabapentin Osteo Bio Flex Vitamin D, Vitamin C",None,None,,None,"['Computerised tomogram', 'Electroencephalogram', 'Magnetic resonance imaging', 'Pyrexia', 'Seizure']",2,MODERNA, 925926,IL,52.0,F,"""by 11am the next day i felt tired, nauseated, fever of 101F and chills, diarrhea, abdominal cramps. i had to call into work. it lasted 24 hours""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,,,,,Penicillins,"['Abdominal pain', 'Chills', 'Diarrhoea', 'Fatigue', 'Impaired work ability', 'Nausea', 'Pyrexia']",1,MODERNA,IM 925927,AR,57.0,F,"Pfizer BioNTech COVID 19 vaccine EUA 0530 on 01/06/21 took naproxen for injection site pain. 0600 on 01/06/21 reports extreme fatigue and continued sore arm at injection site. 1000 started having chills and generalized muscle aches. Temperature elevated to 101.2 at 1545, took Tylenol and temp went down to normal range with 1-2 hours back to 100.0 at 1815. Reports dizziness during that time as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,multivitamin,non\e,none,,none,"['Body temperature increased', 'Chills', 'Dizziness', 'Fatigue', 'Injection site pain', 'Myalgia', 'SARS-CoV-2 test', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 925928,NY,61.0,M,"tingling from fingers thru body to toes, cold sweats, flushing, elevated BP/Pulse (170/110,130) Date of Onset: about 40 min after receiving vaccine. Patient went to ED and received Medrol, benadryl, and famotidine,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,,,,,reports he can not use any OTC items with PEG,"['Blood pressure increased', 'Cold sweat', 'Electrocardiogram', 'Flushing', 'Heart rate increased', 'Paraesthesia']",UNK,PFIZER\BIONTECH,SYR 925929,AZ,33.0,F,"The recipient experienced itchiness all over her body, as well as the sensation of throat closing. Patient was treated with epinephrine, diphenhydramine, famotidine and methylprednisolone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Amitriptyline; Eletriptan; Epinephrine; Aimovig Autoinjector; Topiramate; Venlafaxine,Migraine; Anxiety,Migraine; Anxiety,,Clarithromycin and Strawberries,"['Full blood count', 'Metabolic function test', 'Pruritus', 'Throat tightness']",1,MODERNA, 925930,,46.0,F,Localized cellulitis injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/24/2020,1.0,PVT,,,,,,['Injection site cellulitis'],1,MODERNA,IM 925931,FL,37.0,M,"Patient received the Moderna Covid Vaccine at 1700. By 1725, patient complained of tingling in his RUE, posterior neck, and frontal head. He also reported lightheaded and dizzy. VS were WNL. Rapid Response Team ( RRT) called 1804. RRT arrived at 1808. PO Benadryl 25mg given and symptoms began subsiding. The patient no longer felt lightheaded or dizzy. Dr. visited the patient at 1810. No new orders. Patient left at 1830.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Dizziness', 'Paraesthesia']",1,MODERNA,IM 925932,TN,29.0,F,Patient started having right side facial dropping on. Patient went to ED and followed up with PCP on 1/6/21 and treated with oral steroids for 6 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,PUB,"Vitamin D, Metformin, Fibrin, Hydroxychloroquine",,"anxiety, depression, neuropathy, and migraines",,"Lamictal, Penicillin, Sulfa",['Facial paralysis'],1,MODERNA,IM 925934,NY,51.0,M,"I am a medical doctor. Approximately 1 hour and 15 minutes after the injection I started feeling severely dizzy. My heart rate at that time was 85-90/min and BP was 140/90. Pulse OX was normal. The dizziness improved gradually and lasted for approximately 4 hours. I did not take any medication. Next day, on 1/5/2021 I still felt a little dizzy and I had muscular pain on my L arm. The symptoms completely disappeared on 1/6/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,None,None,"CAD, hyperparathyroidism",,None,"['Dizziness', 'Myalgia']",1,PFIZER\BIONTECH,IM 925935,GA,43.0,F,"I am a medical doctor. Approximately 1 hour and 15 minutes after the injection I started feeling severely dizzy. My heart rate at that time was 85-90/min and BP was 140/90. Pulse OX was normal. The dizziness improved gradually and lasted for approximately 4 hours. I did not take any medication. Next day, on 1/5/2021 I still felt a little dizzy and I had muscular pain on my L arm. The symptoms completely disappeared on 1/6/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,,,,,None reported,['Paraesthesia'],1,MODERNA,IM 925936,AZ,44.0,F,"Started the night of the shot with arm soreness , by 12/31/20 I had a fever of 101.4, leg aches, horrible headache Tylenol did not help it at all, nausea , chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Midodrine, singulair, protonix , vit E, vit C , vit D, fish oil, calcium with magnesium and zinc, mtv , B12",None besides seasonal allergies,Postural orthostatic tachycardia syndrome GERD Allergies,,"Suprax, erythromycin","['Chills', 'Headache', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 925937,TX,59.0,F,"Half of day after receiving the shot the left arm was sore after vaccine. Itchy on right on red ,hot and swollen after the allergy shot . Itching whole body and also the roof of mouth and the back of throat was itching . Head aches . No new symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/23/2020,4.0,PVT,"Crestor 5mg, Immunity vitamins, Benaydril for the recactions",no,Enviromental allergies,,No Allergies to pollien enviromental,"['Headache', 'Oral pruritus', 'Pain in extremity', 'Pruritus', 'Throat irritation']",1,PFIZER\BIONTECH,IM 925938,SC,57.0,F,"Within 5 minutes of receiving the vaccine, I had changes to the hard palate. The ridges on the hard palate (plicae) became completely smooth and remained this way for 36 hours. No treatment was needed. Pharmacist instructed me to report this into VAERS.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,"Arimidex, multivitamin, Vitamin D, Calcium, Prednisone taper-finished the day before vaccine",Contact dermatitis (12/30/20)- treated with Prednisone,History of stage 1 breast cancer diagnosed 11/2016,,Penicillin Oysters,['Oral disorder'],1,PFIZER\BIONTECH,IM 925939,CO,55.0,F,itchy raised hive-like rash appeared about 1 week after vaccine was given at injection site spreading to approx. 10x6cm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,"WP thyroid, HRT, many supplements including fish oil, digestive enzymes, mvi, b12 and B vitamins.",none,"hypothyroidism immune deficiency, recent dx CVID",,"minocycline, bacitracin","['Injection site pruritus', 'Injection site rash', 'Injection site swelling']",UNK,MODERNA, 925940,UT,42.0,F,"Patient reports that she received her shot for COVID on 12/30 and within a day it was sore, painful at the injection site with an area of redness and induration. Progressed into a decrease range of motion and pain in neck, arm, and back. PCP prescribed muscle relaxant and icy hot to affected area. It is improving as of today the redness and swelling have improved but still decrease ROM in R arm, shoulder, and hand.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,Still recovering from COVID-19 infection since October,,none,"['Back pain', 'Injected limb mobility decreased', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Joint range of motion decreased', 'Neck pain', 'Pain in extremity', 'Swelling']",1,MODERNA,IM 925941,,35.0,F,"Chills, headache, fever, sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,unknown,,,,,"['Chills', 'Headache', 'Oropharyngeal pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 925942,,50.0,F,"tinnitus, face tingling, lymph pain, general muscle pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,,,,,,"['Lymph node pain', 'Myalgia', 'Paraesthesia', 'Tinnitus']",2,PFIZER\BIONTECH,IM 925943,TX,53.0,F,"Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injection site swelling, injection site redness, nausea, swollen lymph nodes, sneezing, runny nose, dizziness and weakness, and slight chest pressure. Symptoms came and went but the palm sized redness and swelling at the injection site with extreme itching continues to this day. Used cold compresses, topical lotion for allergies, and Vaseline but nothing helped. Will try Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,MIL,Levothyroxine and Modafinil,None,Hypothyroidism and Narcolepsy (no cataplexy),Injection site irritation to flu vaccine and tetanus shot,"Coconut, latex, nickel, silicone","['Asthenia', 'Chest discomfort', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Hot flush', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy', 'Nausea', 'Pyrexia', 'Rhinorrhoea', 'Sneezing']",1,PFIZER\BIONTECH,IM 925944,IL,28.0,F,"Per patient report, localized reaction started a few hours after. Continues to worsen. Arm now large, swollen, about the size of a golf ball per patient. Red and hot to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Erythema', 'Local reaction', 'Peripheral swelling', 'Skin warm']",1,MODERNA,IM 925945,CO,60.0,F,lyphedema and pain at L axillary and fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PUB,levothyroxine,None,hypothyroidism,,None,"['Axillary pain', 'Fatigue', 'Lymphoedema']",1,MODERNA,IM 925946,,58.0,F,"low grade fever, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,,,,,,"['Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925947,AZ,29.0,F,Redness and swelling surrounding injection site (3in diameter) Swollen lymph node in armpit.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,Birth Control Pills,,,,,"['Injection site erythema', 'Injection site swelling', 'Lymphadenopathy']",UNK,MODERNA,SYR 925948,IN,68.0,F,Dizziness especially in the morning and with position changes. No treatment. Has happened since Tuesday am.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Multiple vitamins, melatonin, baby aspirin",None,MGUS,,None Known,['Dizziness postural'],1,MODERNA,IM 925949,MI,59.0,F,"Large knot (2 1/4 x 2 1/4), warm and red at injection site. started to itch on the 5th, didnt think too much about it then got progressively worse on the 6th w the knot developing and red/warm. today 1/7, the knot is reducing slightly but the redness is spreading.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,"CoQ10, Vit D, Zinc, Emergencee Immune drink, Atorvastatin, ProBio5 & Biocleanse (Plexus)",none,high cholesterol,,no,"['Injection site erythema', 'Injection site nodule', 'Injection site warmth', 'Pruritus']",UNK,MODERNA,IM 925950,TX,52.0,M,"LOCAL SORENESS AT SITE DAY 1 DAY 2 SORNESS ON SITE AND UPPER ARM GOING INTO SHOULDER DAY 3 @ 3AM FELT HEANEYNESS IN CHEST, SEVER BODY ACHES, PRODUCTIVE COUGH, COUGHING UP ACID TASTE",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,PVT,VIT D VIT C ZINC WITH QUERCETIN,ASTHMA,ASTHMA,,NO,"['Arthralgia', 'Chest X-ray', 'Chest discomfort', 'Dysgeusia', 'Injection site pain', 'Pain', 'Productive cough']",2,MODERNA,IM 925951,,62.0,F,Patient report HA and fever. Treatment include Tylenol .,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925952,TX,63.0,F,"Chills,low grade fever for 2 days,body pain from neck to knees for 7 days. Some pain still exists but is getting better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/03/2021,3.0,PUB,Multivitamin and Black Cohash,None,None,,None,"['Abdominal pain', 'Arthralgia', 'Chest pain', 'Chills', 'Neck pain', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 925953,IN,27.0,F,"Fever 100, body aches, severe headache, nausea, earache, soreness in arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,None,None,None,,"Penicillin, amoxicillin, augmenton, clindamyaxin, keflex","['Ear pain', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 925954,AK,32.0,F,"Fatigue, Aches and myalgias, shoulders, neck and back, and syncopal episode (passed out in bathroom no injuries continues to monitor) recovered well",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Multivitamin,none,Seasonal allergies Hypothyroidism Irritable bowel syndrome,,Birch house dust mite grass pollen dog dander cat dander Birch Mild weed pollen house dust mite grass pollen dog dander cat dander weed pollen,"['Fatigue', 'Loss of consciousness', 'Myalgia', 'Pain', 'Syncope']",UNK,MODERNA, 925955,IN,54.0,M,"Generalized pain, fatigue, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"pantoprazole 40mg BID, Vitamin D 2000U daily, multi vitamine 2 tabs a day",GERD,"GERD, loss of smell, BPH",mild fatigue,no,"['Chills', 'Fatigue', 'Pain']",2,PFIZER\BIONTECH,IM 925956,MN,38.0,M,"Fever max if 101.4, muscle aches and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Atorvastatin,None,None,,None,"['Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 925957,MA,69.0,F,after 6 days bright red area (circular) around injection site (no itching or rash),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,WRK,"ibuprofen 400 mgm qd , lorazepam 0.5 at bedtime",none,"osteoarthritis (knees, hands)",,"peanut oil, lisinopril",['Injection site erythema'],1,MODERNA,SYR 925958,UT,36.0,F,"01/04/2021 9am - vaccine administered - felt fine, went climbing. 3pm mild fatigue began. 6pm injection arm was practically unusable, had to get help to undress, extreme chills with trembling that made it difficult to breath. Hands turned pale and where hard to use. 8:30pm fever reached 103 F and extreme body aches and joint pain began. Splitting headache also began. The trembling stopped but a dry cough began. Between 8:30pm and 11pm fever fluctuated wildly from 101 F into the 103 F until at 11pm the fever reached 104 F. 11pm Fever peaked at 104 F, took two advil and a cool shower as my brain felt like it was on fire and I had the worst headache of my life. I felt confused and disoriented. With in minutes of taking a cool shower and putting icepacks on my neck and wrists fever dropped to 103 F range. 01/05/2021 Fever fluctuated in the 101 F- 103 F range until 4am, awoke with sheets completely soaked in sweat. 7am - 12pm fever stayed within 101 F range. Extreme fatigue, moderate joint pain, moderate body aches, moderate headache. Was unable to get out of bed without major effort. 7pm temperature returned to normal range 97.3 01/06/2021 8am moderate fatigue, felt confused, disoriented and dizzy. Arm was useable but very painful and ROM limited 7pm extreme fatigue 01/07/2021 10am extremely dizzy and disoriented temperature 96.9",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PUB,Mirena IUD,none,none,,erythromycin,"['Arthralgia', 'Burning sensation', 'Chills', 'Confusional state', 'Cough', 'Disorientation', 'Dyspnoea', 'Fatigue', 'Headache', 'Injected limb mobility decreased', 'Pain', 'Pallor', 'Pyrexia', 'Tremor']",1,MODERNA,IM 925959,,37.0,F,fever chills rash swelling redness,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/29/2020,1.0,PVT,,,,,,"['Chills', 'Erythema', 'Pyrexia', 'Rash', 'Swelling']",1,MODERNA,IM 925960,PA,27.0,F,"Nausea/vomiting, fevers, painful supraclavicular lymphadenopathy, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Simponi Ursodiol Lexapro,None,Ulcerative colitis Primary sclerosing cholangitis Anxiety,,None,"['Lymphadenopathy', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 925961,FL,67.0,F,cellulitis surrounding injection site right upper arm,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,PVT,multivitamin,none,none,,NKA,['Injection site cellulitis'],1,MODERNA,SYR 925962,PR,51.0,F,From the second day of had been administered the area turned red swollen and the days went by and the rash is bigger and it has been 12 days and it still the same,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/27/2020,1.0,UNK,No,,,,No,"['Injection site erythema', 'Injection site swelling', 'Rash']",1,MODERNA,IM 925963,FL,37.0,F,"tachycardic, feeling flushed and as though throat is closing.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Cetrizine 10 mg PO Daily,Unknown,IBS Seasonal Allergies,,"Oranges, Flaxseed, Horseradish, IV Contrast, Benzoyl Peroxide","['Blood glucose normal', 'Flushing', 'Full blood count normal', 'Metabolic function test', 'Tachycardia', 'Throat tightness']",1,MODERNA,IM 925964,NC,48.0,F,"Arm red and itchy at injection site. This reaction just started today, 1-7-2021. (One week after injection) Up until today the only reaction I had was pain at the injection site that subsided on 1-3-2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PUB,"Synthroid, phentermine, ozempic, farxiga, vitamin D3, metformin, atorvastatin, oxybutynin, losartan, celexa",None,"Diabetes, hypothyroidism, PCOS, high blood pressure, high cholesterol","I get a similar localized reaction whenever I get the flu vaccine, including this year, but it usually happens within a day of r",Unknown,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,IM 925965,CT,46.0,F,"On the 6 day after injection, site became itchy at night. Woke up on the 7th day after injection to the injection site described as large, red, swollen, sore, hot to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/07/2021,7.0,PVT,"Vita B Complex, Vita C, Magnesium, Biotin, Vita D",,,,Penicillin allergies (GI) as an infant-not anaphylaxis,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 925966,MD,22.0,F,"Beginning with right arm pain after injection, and the day after with slight bruising to the injection site. Then after eight days a rash appeared just below the injection site with slight swelling and itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/06/2021,8.0,WRK,,NONE,NONE,,NONE,"['Injection site bruising', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Pain in extremity']",1,MODERNA,SYR 925967,,51.0,F,fever 102F aches,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925969,WA,63.0,F,"This is a self report: two days after the vaccine I developed severe heart burn ( something I have never experienced). Several over the counter medication were used without relief. . The heart burn was followed by a horrible gastric disturbance. I experienced abdominal pain, cramping and rectal pain. During this time my temperature remand between 100.0 - 101.0 with fatigue and malaise. I have also noticed several welts on my body. I?m typically a very health person and have never experienced any of these experiences before.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/02/2021,3.0,UNK,None,None,None,,None,"['Abdominal pain', 'Body temperature increased', 'Dyspepsia', 'Fatigue', 'Gastric disorder', 'Malaise', 'Muscle spasms', 'Proctalgia', 'Urticaria']",UNK,PFIZER\BIONTECH,SC 925970,PA,62.0,F,"within 20 minutes: metallic taste in mouth, tingling and numb lips/tongue - resolved with OTC antihistamine use",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,OA of the knee,OA,,Penicillin Biaxin Bee Stings,"['Dysgeusia', 'Hypoaesthesia oral', 'Paraesthesia oral']",UNK,MODERNA, 925972,CA,36.0,F,"Induration, redness, warmth. Spreading each day. No response to antibiotics or anti histamines. Dx with cellulitis a d delayed local reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/03/2021,8.0,WRK,"Xarelto, plaquenil, metoprolol, gabapentin",None,"History of DVTs in arms, sleep apnea",,"Sulfa, macrobid","['Cellulitis', 'Erythema', 'Induration', 'Local reaction', 'Skin warm']",1,MODERNA,IM 925973,NJ,25.0,F,"Received Moderna COVID-19 vaccine around 8:00 am on 1/4/2021. Same day in the afternoon, developed left facial numbness and right facial weakness, which had exacerbated on the next two days. On 1/5/2021, went to ED of Medical Center. Was evaluated by ED doctor and ED attending and was diagnosed with Bell's Palsy. Neurology consulted. Steroids were not recommended as it would make vaccine not effective. Lyme test was obtained (reported negative). Was discharged later on 1/5/2021 and was advised to follow up with OMS and neurology.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,UNK,Ibuprofen,Migraine,None,,None,"['Borrelia test negative', 'Facial paralysis', 'Facial paresis', 'Hypoaesthesia']",1,MODERNA,IM 925974,MA,55.0,F,"Same evening body aches and injection site was painful. In 24 hrs my lymph nodes were swollen, also neck and arm pit. I also had headaches and body aches across my shoulder, neck and back.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,No,No,No,,No,"['Headache', 'Injection site pain', 'Lymphadenopathy', 'Pain']",1,PFIZER\BIONTECH,SYR 925975,IL,33.0,F,"Patient's arm was feeling tight after the injection, The sleeve seemed to be tightening her arm and after the injection she felt all the blood rush down her arm and she stated the injection site came out a bit and had a little bump. She went to the observation area and was feeling faint and light headed. She was taken to a separate room and she became a little faint and was given some water and kept longer for observation. After about an hour shes feeling much better and her color as returned and only feeling slightly light-headed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,SEN,OCP,NONE,NONE,,NONE,"['Dizziness', 'Injection site mass', 'Limb discomfort', 'Vital capacity normal']",1,PFIZER\BIONTECH,IM 925976,,36.0,F,"fever 99.7F, chills headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Chills', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925977,WA,53.0,F,"onset of redness, swelling, and heat at injection site. diagnosed with cellulitis",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,WRK,"hydrocholorthiazide, lisinopril, levothyroxine, potassium, vitamin D, vitamin B",none,"hypothyroidism, HTN",,reglan,"['Cellulitis', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 925978,WA,76.0,M,"Localized swelling, redness and itching 6 cm in diameter at injection site. it developed about 7 days after the injection",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/05/2021,7.0,PVT,atorvastatin lisinopril chlorothalidone ASA,,in good health,,sesame oil,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Swelling']",1,MODERNA,IM 925980,CA,39.0,F,"site soreness (started within 3 hours of injection and is still sore 2 days later) , sleep disturbance night of injection, elevated temp of 100deg (started at 0200 on the 6th and lasted for 24 hours), whole body aches esp neck and back pain (Started when temp started and has lasted after temp has stopped for a total of 31 hours). Migraine with sensitivity to light (started at 0400 on the 6th and lasted for 5 hours). Nausea and heartburn (started on the 6th at 1845 lasting 5 hours despite taking famotidine)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"multi vitamin and hair and nails supplement (biotin, silica, Vit C, proline, zinc, copper, flaxseed oil and gotu kola)",none,none,,sensitivity to plums and raw almonds,"['Body temperature increased', 'Dyspepsia', 'Injection site pain', 'Migraine', 'Nausea', 'Pain', 'Photophobia', 'Sleep disorder']",1,PFIZER\BIONTECH,IM 925981,IL,54.0,F,"9 days after injection developed injection site reaction of redness, swelling, itching, warm to touch along with mild rash on bilateral lower extremities.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/07/2021,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Rash']",1,MODERNA,IM 925982,NM,28.0,M,"fever, headache, coughing, fatigue, loss of smell",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,none,none,none,,nickel,"['Anosmia', 'Cough', 'Fatigue', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 925983,NY,34.0,F,"Itching after injection with redness. 3 hours later with raised 2 inch hive at injection site with associated warmth, redness. Did not spread from that area. 2inch diameter.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,UNK,"Multivitamin, ibuprofen",,,,"Latex, kiwi, shellfish, bee venom","['Injection site erythema', 'Injection site pruritus', 'Injection site urticaria', 'Injection site warmth']",UNK,MODERNA,IM 925984,MN,38.0,M,"Fever max 101.4, muscle aches with headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Atorvastatin,None,None,,None,"['Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 925985,,34.0,F,"Fever 104.0F, chills, aches",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925986,MN,23.0,F,"1/4/21 noon C/O nausea and Headache, 1/5/21 C/O body aches, ""COVID symptoms"", fever, chills, headache, and body rash. Symptoms improved expect for rash which patient states is very itchy. NP instructed her to take Claritin daily, use hydrocortisone cream, and Benadryl at night time. Patient is also reporting all symptoms to VSAFE.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,,,,,,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Rash', 'Rash pruritic']",1,MODERNA,IM 925987,NJ,53.0,F,Very achy and tired the following day. very tender at injection site for three days following injection. Bruising at injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/27/2020,1.0,OTH,"Vitamin D, Zinc, Zyrtec, baby aspirin",No,None,Got severe flu-like symptoms after flu shot in 1992,"Strawberries, pineapple","['Fatigue', 'Injection site bruising', 'Injection site pain', 'Pain']",1,PFIZER\BIONTECH,IM 925988,MO,35.0,F,"Woke up with chills, headache, weak, felt like fainting, arm pain. Called off work. Fever of 100.4.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/28/2020,1.0,PVT,no,no,no,flu shot,no,"['Asthenia', 'Chills', 'Dizziness', 'Headache', 'Impaired work ability', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 925989,GA,67.0,F,"Patient complained of facial flushing. Denies respiratory distress, is A& O x 4, V/S are: 1st attempt at 11:20 AM: BP 176/78; P-88; RR 20, 2nd attempt at 11:32 AM: BP 130/72; P-82; RR-18. Patient offered monitoring for 1 hour, refused ,patient was stable, reports minimized facial flushing, no respiratory distress reported. Patient encourage to go to the ER if having any trouble breathing, verbalized understanding.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,['Flushing'],1,MODERNA,IM 925990,CO,86.0,F,"3 cm.X6 cm. raised, red, pruritic rash at site of vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,PVT,"Eliquis, Metoprolal, Thyroid, Coenzme, Q10, Simvastatin, Vit D3, Vit B12, simethacone",None,"Type 2 diabetes, history of one episode of atrial fibrillation, hypercholesterolemia",,None known,"['Injection site erythema', 'Injection site rash', 'Rash pruritic', 'Vaccination site swelling']",1,MODERNA,IM 925991,CO,57.0,M,"Severe Body Aches, Fever little over 100 degrees F, Chills. Started about 9 hours after injection - lasted 7-8 hours. Arm pain but that was no big deal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Losartan,COVID,HTN,,NKDA,"['Chills', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 925992,OH,73.0,F,"PHONE MESSAGE- UNABLE TO REACH FOR FURTHER INFO X2. STATES NO REACTION UNTIL 1/4/2021- BILATERAL ""THROBBING"" LEGS - NO RELIEF WITH OTC NSAIDS",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/04/2021,2.0,PUB,UNKNOWN,NONE STATED,UNKNOWN,,UNKNOWN,['Limb discomfort'],1,MODERNA,IM 925993,,38.0,F,"low grade fever, arm swelling, aches, chills fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/24/2020,1.0,PVT,,,,,,"['Chills', 'Fatigue', 'Pain', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 925994,,53.0,F,"vaccine administered at 1040. 30 minutes of observation occurred. At 1126, patient returned to clinic reporting dizziness, and generalized redness on her body. Vital signs taken- temp 99.2, HR 108, O2 96%, BP 192/96, RR 18. First Responder called. Pt offered water and reported her throat was closing. Epipen was administered. VS after Epi 96% on 2L O2, HR 117, BP 192/101. Pt reported lips starting swell (not observed by RN). First Responder team arrived. Report given. First Response team transported patient to the ED for further evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,,,,,,"['Dizziness', 'Erythema', 'Lip swelling', 'Oropharyngeal discomfort']",1,MODERNA,IM 925995,MN,48.0,F,"Nausea, chills, fever, body aches, headache, rash on arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,"Sertraline, Zyrtec , aspirin",None,None,,None,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Rash']",1,MODERNA,IM 925996,TX,34.0,M,"Pain in the injection site a couple of hours after injection. Felt slight dizziness on the day of administration (on and off). The headache started to appear around 3pm the following day and continues on 2 days after. Feeling weak. Diarrhea also started two days after the administration. Noticed body aches in upper and lower body. Four days after the administration, no more pain in the injection site. Diarrhea had subsided but the headache is still there on and off.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,WRK,Vitamin C,None that I am aware of.,,,NKDA,"['Asthenia', 'Diarrhoea', 'Dizziness', 'Headache', 'Injection site pain', 'Pain']",1,MODERNA,IM 925997,NY,30.0,F,"Nausea, fever, chills, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,,,01/07/2021,,PVT,Plaquenil,No,Lupus,,No,"['Chills', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 925998,NY,42.0,F,bouts of tachycardia at rest >100bpm lasted for about 3 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Vit D , zinc and Vit C",none,hx of hodgkins lymphoma in remission since 2005,,vicodin,['Tachycardia'],1,MODERNA,IM 925999,WI,52.0,F,"Chills/ slight headache for two days after - still able to work, just didn't feel ""normal"". Developed hives/welts on chest up neck and onto chin on 1/6/21 in the evening along with a slight headache. Had a virtual visit with Urgent care and was prescribed Prednisone and zyrtec for the next 5 days and told to report.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,"simvastatin, sertraline",none,none,,"shellfish, latex, seasonal","['Chills', 'Feeling abnormal', 'Headache', 'Urticaria']",1,MODERNA,IM 926000,IL,31.0,F,"2nd day-nausea, arm site pain which subsided. day 5-7 -severe itching around injection site. swelling and erythema as well",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PHM,none,none,,,amoxicillin,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Nausea']",1,MODERNA, 926001,,44.0,F,"fever 101.0, chills, aches",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 926002,KY,53.0,F,"(unsure if this relates to vaccination) Had an extreme allergic reaction at 10 pm Monday night (Jan 4, 2021), then another at 3 am Tuesday morning. Took benadryl 25 mg with each episode. At 6:15 am I passed completely out at sink, hitting my head hard on hardwood floor. Went to ER for scans. All scans were clear of brain and chest, awaiting heart results, with further testing for allergens coming up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/05/2021,6.0,PUB,Ortho Novum (birth control pill),"Had two allergic reactions weeks prior to vaccination. Unsure of cause. First one minor, second one torso only.",,,None known,"['Blood test', 'Chest scan', 'Computerised tomogram normal', 'Head injury', 'Hypersensitivity', 'Loss of consciousness', 'Scan normal']",1,MODERNA,IM 926003,NE,39.0,M,"During administration of the vaccine, the RN noted that the vanishpoint syringe (automatic retractable needle syringe) began retracting too early before the RN had fully depressed the plunger and before all of the vaccine was in the patient's muscle. In addition, the RN noted that vaccine was leaking out of the syringe and down the patient's arm. The RN was unable to determine the exact amount that entered the patient and how much leaked out of the syringe. The RN spoke with Health Deparment's physician who was on-site. The RN and the physician looked at the syringe and discussed the incident. It was determined since some of the vaccine went into the patient, the dose should not be repeated for concerns of overdosing the patient. The patient was informed that a VAERS report would be filed and that we would attempt to contact moderna. The patient was advised to come for the second dose as scheduled on their card and that the patient could speak with their healthcare provider about whether or not a titer/antibody test should be run after the second dose to ensure the patient had adequate immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,,,,,,"['Syringe issue', 'Underdose']",1,MODERNA,IM 926004,CT,64.0,F,"I have a dr appt next week, I did have some mid numbness on the top of my leg that I have had for a while, thought it might have been related to my knee surgery over 10 years ago, and developed leg cramps that I contributed to my diet most recently, so not sure if this is related or just bad timing",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,none,none,none,,right leg got numb and became drooped cant move big toe very well leg felt heavy and I walk different with the right foot,"['Gait deviation', 'Hypoaesthesia', 'Limb discomfort', 'Muscle spasms', 'Peroneal nerve palsy']",1,MODERNA, 926005,,46.0,F,"fever 100.3, lymph pain, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,,,,,,"['Lymph node pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 926007,CA,72.0,M,PHLEBITIS OF LEFT BASILIC VEIN,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/29/2020,3.0,PVT,UROXATROL SOTALOL ELIQUIS MULTIVITAMIN LIIPO-FLAVANOID,NONE,NONE,,NKDA,"['Phlebitis', 'Ultrasound scan abnormal']",1,MODERNA,IM 926008,CA,57.0,F,Received vaccine on 1/6/2021 at 10:30 AM. Sneezing and runny nose since 1/6/2021 10:00 PM.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,Atenolol 50 mg daily,nonw,Hypertension,,none,"['Rhinorrhoea', 'Sneezing']",1,PFIZER\BIONTECH,IM 926009,,25.0,M,"Headache, fever, chills, fatigue around 18 hours after shot. Additionally, I woke up the morning after to pain in my toe, which spread to my foot and groin lymph nodes. I eventually went to the ER and was told my toe was infected. I had previously had a small cut on my toe and the doctor believes that the inflammatory response my body initiated from the vaccine exacerbated this infection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,UNK,None,,,,None,"['Fatigue', 'Feeling cold', 'Groin pain', 'Headache', 'Localised infection', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 926010,OK,48.0,F,"An irregular shaped Blister at site of vaccination was noticed a day after the first vaccine dose, and which then burst producing clear liquid with open skin when the bandage was removed. It healed later with a scar.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,None,,None,,Not known,"['Blister rupture', 'Injection site scar', 'Injection site vesicles']",1,PFIZER\BIONTECH,IM 926011,CO,33.0,F,"Left arm itching and localized rash/hive at injection site started on day 5-6 after injection. ~3x3in. Rash lasted for ~5d, itching for ~7d. Daily zyrtec taken day 1-3 of rash. Of note, acyclovir (new medication) taken 1 day (2 doses) before rash development and then stopped",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/29/2020,6.0,PVT,Mirena IUD,None,GI bleed from AVMs,,Cutaneous pineapple lip allergy,"['Injection site rash', 'Injection site urticaria', 'Pruritus']",1,MODERNA,IM 926012,,34.0,M,"Patient describes chest pain, shallow breathing, sharp chest pain, patient has previous cardiac problems and could recognize. He also reports feeling fatigued and flushed (hot flashes), body aches, headache mildness, injection site pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,Regular medications,,,,,"['Chest pain', 'Fatigue', 'Flushing', 'Headache', 'Hot flush', 'Hypopnoea', 'Injection site pain', 'Pain']",UNK,PFIZER\BIONTECH, 926013,PA,35.0,F,"Began with fatigue on day 2 and sore arm, day 3 temp of 101.6, chills, body aches, continued through day 5.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,None,None,None,,None,"['Body temperature increased', 'Fatigue', 'Pain', 'Pain in extremity', 'SARS-CoV-2 test negative']",1,MODERNA,IM 926014,KS,60.0,F,"Vomited twice in 2 hours could not eat headache fatigue 3 days ate very little because did not feel like eating Rash on right behind check and down a little bit on thigh very red painful and swelling I am on SMZ-TMP DS Tab 800-160 twice a day rash still there but not as painful. Fever as high as 102.7 for several hours on 01/03/2021 then ran in the 101.5 range for 01/04/2021, then on 01/5/2021 it ran in the low 100's. It is getting better every day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/03/2021,3.0,PVT,Novalog Trujeo Warfarin Citalopram Ramipril Pantoprazole Clopidogrel Hydroco FeroSul,"had surgery on my foot and had a wound vac on, Surgery was on 11/22/20",Diabetes,,Codien makes me sick to stomach and Pennicillian gives me diar,"['Decreased appetite', 'Erythema', 'Fatigue', 'Headache', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Rash', 'Vomiting']",UNK,MODERNA,SYR 926015,CA,50.0,F,"Pt given 2nd dose of pfizer vaccination given by LVN RN informed that pt was not feeling well at 0834 by LVN. RN informed front desk to call rapid response at 0835. Pt transferred from waiting area to wheel chair then to gurney 0836 vs: bp:151/109 hr:95 02sat: 90 room air- complaint of dizziness, feeling like she is going to pass out, headache 6/10, diaphoretic hands bilaterally, tearful, feeling like she is going to pass out, complaint of congestion, notes she has history of htn and sleep apnea, pt states that she was not feeling well since administration of vaccination however did not inform LVN. 0837:2L o2 via nasal canula 0840: vs: BP 138/75 hr:83 02 sat:94 97.7 temp: on 2L nasal cannula, rapid response arrived report given, pt still feeling the same. 0845: vs bp: 133/84 hr: 79 o2sat: 94 0850: rapid response nurse cleared pt to be discharged, pt given option of going to ED for observation however declined at the time. 0851: pt sat up repeat o2sat: 95 on room air- states that she is feeling better, stating ""I think I just have to go home and take a nap"" 0855: pt requesting to be discharged, encouraged to have someone drive her home states she will call her sister- pt never picked up phone to call sister- then insisted she is fine to dive herself home. 0856: cleared with -supervisor that pt okay to be wheeled down to car by LVN be wheeled down to car- pt given ed precautions. 0907: LVN reported that pt elected to go to ED as she was experiencing dizziness per LVN. In ED pt given IV Benadryl 25 mg, tordol 15mg iv, 1 liter Lactated ringers, 4 mg Zofran iv",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,"lisinopril (PRINIVIL, ZESTRIL) 20 MG tablet sig:Take 1 tablet (20 mg) by mouth daily tranexamic acid (LYSTEDA) 650 MG Sig: Take two tabs (1300mg) three times daily for 5 days during very heavy vaginal bleeding motrin 600mg 1 every 6 hour",unknown,hypertension and sleep apnea,,Depo-Provera neomycin,"['Dizziness', 'Hyperhidrosis', 'Malaise', 'Nasal congestion', 'Presyncope', 'Tearfulness']",2,PFIZER\BIONTECH,IM 926016,KY,60.0,F,"""very sore arm for 2 days, difficulty lifting arm, pain woke me in the night. Also developed fever and nausea which only lasted about 6 hours""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,none reported,"['Mobility decreased', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Sleep disorder']",1,MODERNA,IM 926017,FL,70.0,F,"HIGH BP AND PULSE BETWEEN 9:30 PM AND MIDNIGHT THE EVENING AFTER THE VACCINE: 175/99 PULSE 149, 151/79 PULSE 115, 154/73 PULSE 139, 163/77 PULSE 137.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,"Eliquist 5mg, Aspirin 81mg, Verapermil 120mg, Rosuvastatin 5mg, Levothyroxine 125mcg, Culterelle Probiotic, Vitamin D3 5000mg, Vitamin B-12 500mcg, VitaFusion Calcium & D3 500mg/25mcg, Natures Bnty Hair,Skin,Nails 5000mcg, Ducosate Sodium",,AFIB/ heart flutters. sleep apnea. Arthritis. Hypothyroidism. Allergies,,"Drugs: Morphine, Codeine, Tylox, Oxycotin, Oxycodone, Kinesed, some anesthesia>>>severe urticaria, hives, nausea, vomiting Foods: Melon >>> swelling, hives, vomiting ; Black or red Pepper, hot sauce, hot spicy seasoning>>>choking Animals: Cats>>> hives, sneezing, swelling, Sinusitis Other: Hay Fever, Pollen, Dust>>>Sneezing, swelling, hives, Sinusitis","['Heart rate increased', 'Hypertension']",2,MODERNA,IM 926018,NE,39.0,F,"Swollen Rash and itching in Left arm, increasing in size over 2-3 days. Has had to take Benadryl to relieve itching at night.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PUB,,,,,,"['Pruritus', 'Rash papular']",UNK,MODERNA,IM 926019,IL,40.0,F,"Day 9 developed redness, swelling, heat, hardness & itching at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/07/2021,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 926020,WI,40.0,F,"at 1210 patient received the moderna vaccination o. 5ml in her left arm she went to sit down and at 1218 she stated she doesn't feel right she got all panicky and restless. we placed a pulse ox on her her HR was high 160's oxygenation 100% BP 158/88 she said her heart felt like it was racing and she was all hot and her lips were tingly.... another RN present said her lips looked a little blue at one point rapid response called . Patient stated she felt a little better, heart rate was in 120's rapid response team decided to send her to the ER for observation",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,no,,,,"['Cyanosis', 'Feeling abnormal', 'Feeling hot', 'Heart rate increased', 'Palpitations', 'Panic reaction', 'Paraesthesia oral', 'Restlessness']",1,MODERNA,IM 926021,MD,69.0,F,"Vaccine recipient complained of ""some left-sided numbness in her ears and arms"" almost immediately. Report received second-hand from the vaccine clinic director.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,,,,,['Hypoaesthesia'],1,PFIZER\BIONTECH,IM 926022,,45.0,F,"Low-grade fever, myalgia, general malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,Enalapril maleate 5 mg BID,"COVID-19, 45 days prior",Hypertension,,Currently none. Anamnestic data about allergy to dust.,"['Malaise', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 926023,TN,42.0,F,At 3:30 am 1/7/2021 I woke up to my whole body head to toe covered in hives/rash and my lips were swelling. I took 2 Benadryl and slept. At 6 am lip swelling went down but hives are all over still. At 8 am I took another Benadryl. It is now 12:30 and still there and itching.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/07/2021,5.0,PUB,Levothyroxine,,,,None,"['Lip swelling', 'Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 926024,TX,26.0,F,"Moderna COVID-19 Vaccine EUA Rash at injection site on the morning of Day 6, no pain or itching, and rash went away by 7pm that night. Rash returned at injection site with itching on day 8 (today). The itching is intermittent so far today.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/05/2021,6.0,PVT,,,,,Ancef,"['Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 926025,IN,38.0,M,"fever 1/5/21 102F chills same evening 1/6/21 chills and fever about 4am. Elevated heart rate all day headache, joint pain, muscle soreness, fever all day approximately 11pm felt much better. heart rate returned to normal, temperature 100f 1/7/21 local pain in injection site. no more fever. normal heart rate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,100 mg vitamin d b complex vitamin multivitamin for men 50+ Omega 3-6-9 vitamin,Cold symptoms 12/19/2020-12/23,none,,none,"['Arthralgia', 'Chills', 'Headache', 'Heart rate increased', 'Injection site pain', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 926026,FL,24.0,F,12-15 hours after the injection I woke up with moderate to severe body aches and fatigue. These two symptoms lasted about 12-18 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,None,None,None,,None,"['Fatigue', 'Pain']",1,PFIZER\BIONTECH,IM 926027,CT,19.0,F,"Begin with abdominal pain on December 30 when she woke up, continued with nausea, then headaches, loss of appetite and by Sunday January 3, 2021 swollen lymph node in left arm pit. Was seen on January 4, 2021, told to call or return if it gets worse. As of today she still has a swollen lymph node and swelling and redness around her injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,Vitamin D 2000 cu fluticasone propionate 50 mcg cetirizine hydrochloride 10 mg lo loestrin FE 1-10,none,none,,Augmentin,"['Abdominal pain', 'Decreased appetite', 'Headache', 'Injection site erythema', 'Injection site swelling', 'Lymphadenopathy', 'Nausea']",1,MODERNA,IM 926029,TX,38.0,F,developed angioedema of lower lip more than one hour after injection continued to progress even at 12 hours after. Had associated wheezing but no respiratory.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,none,none,none,,"strawberry, pineapples, minocycline, doxycline","['Angioedema', 'Wheezing']",1,MODERNA,IM 926030,TX,54.0,F,Stomach cramps and vomiting. Vomited once then felt fine. Resolved in one day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Rouvastatin; Unithroid; Famotidine; Vit D2; Losartan/HCTZ; Sertraline; Ozempic; Celebrex; Hydroxyzine; Colace,None,Hypertension; Hypothyroidism; Papillary thyroid cancer; Hyperlipidemia; Gerd.,,None,"['Abdominal pain upper', 'Vomiting']",1,PFIZER\BIONTECH,IM 926031,MT,49.0,F,"Throat tingling 10 minutes after shot administered. Sent to ER for treatment (solumedrol, famotidine, diphenhydramine administered)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,['Pharyngeal paraesthesia'],UNK,MODERNA, 926032,AZ,58.0,F,Stiff neck severe headache severe diarrhea and nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/05/2021,2.0,OTH,"Benadryl, allpurinol",None,None,,"Sulfa, quinolones, contrast","['Diarrhoea', 'Headache', 'Musculoskeletal stiffness', 'Nausea']",1,PFIZER\BIONTECH,IM 926033,,37.0,F,Pt reported immediate redness and lump to injection site and shortly after developed flushing to face/neck/arms with itching about 10 minutes after vaccine. Pt received Benadryl PO with recovery. Provider notified and approved course of treatment. No other f/u concerns at this time.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Flushing', 'Immediate post-injection reaction', 'Injection site erythema', 'Injection site mass', 'Pruritus']",1,PFIZER\BIONTECH,IM 926034,WA,41.0,F,"Fever of 101, diarrhea, vomiting, fatigue, nauseous, no appetite, arm red and swollen at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Prazocin, Promethazine, Montelukast, Pepcid",Positive COVID-19 12/6,,,"Clindamycin, penicillin's, Sulfa antibiotics","['Decreased appetite', 'Diarrhoea', 'Fatigue', 'Injection site erythema', 'Injection site swelling', 'Nausea', 'Pyrexia', 'Vomiting']",UNK,MODERNA,IM 926035,MD,54.0,F,"Information relayed second hand from vaccine clinic director. Recipient c/o muscle pain immediately after the Moderna injection on 12/29/2020 and congestion and body aches 3 days after the injection. Now yesterday, 8 days after the injection she has a circular red area below the injection site that is slightly warm to touch, itchy and swollen. She is taking Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PVT,,,,,,"['Immediate post-injection reaction', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Myalgia', 'Pain', 'Respiratory tract congestion']",1,MODERNA,IM 926036,ND,25.0,F,"Localized reaction at the site of injection- pain, redness, warm to touch, and swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"venlafaxine, aviane",sinus infection,none,,no known medical allergies,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Local reaction']",1,MODERNA,IM 926037,CT,40.0,F,"Rash and redness, pain (similar to sunburn or bruise) ghat developed 7 days post vaccine. Small bump at injection site that was also noted day 7.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/04/2021,7.0,PUB,Wellbutrin XL 300 mg/daily,None,None,,NKDA,"['Erythema', 'Injection site swelling', 'Pain', 'Rash']",1,MODERNA,IM 926038,UT,28.0,F,Red arm Hard bumps under skin Soreness in arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,Tylenol,,,,Penicillins,"['Erythema', 'Pain in extremity', 'Rash papular']",1,MODERNA,IM 926039,KY,40.0,F,"Swelling, redness, and warmth of the upper arm a week after injection. Cold compress and Tylenol administered with no relief redness and swelling spreading across arm. Shoulder, neck and arm pain. Also experiencing nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,Took Tylenol 400mg prior to injection.,,,,"Pertussis vaccine, Levaquin, Latex,","['Arthralgia', 'Erythema', 'Nausea', 'Neck pain', 'Pain in extremity', 'Peripheral swelling', 'Skin warm']",UNK,MODERNA,IM 926040,NY,47.0,F,"headache/sneezing/runny nose occurring 16hours after vaccination lasting 24hours total fever/chills/fatigue, highest reading 100.7, occurring 19 hours after vaccination lasting 12 hours total generalized GI distress without nausea/vomitting starting within 2 hours of vaccination and lasting over 36hours; difficult to discern from my typical GI issues but certainly seemed to be heightened",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Vit D and calcium supplement,"heightened allergies few wks before vaccination with mild sneezing, covid neg test on 12/11/20","seasonal allergies, new history of GI distress and food allergies starting at age 40, no specific diagnosis",,"Med: biaxin Food: gluten sensitive, dairy, peanuts, apples environmental allergies seasonally","['Abdominal discomfort', 'Chills', 'Condition aggravated', 'Fatigue', 'Headache', 'Pyrexia', 'Rhinorrhoea', 'Sneezing']",UNK,MODERNA, 926041,CA,36.0,F,"Hives on left arm initially below injection site, but gradually growing in size up towards injection site. Zyrtec has helped. Hives still present but getting better.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/02/2021,9.0,WRK,"Claritin, vitamin D, vitamin B12, multivitamin",,"Venous insufficiency, dry eye, patellofemoral syndrome",,"Shellfish, dust, pollen",['Injection site urticaria'],1,MODERNA,IM 926042,PA,41.0,F,"Developed shortness of breath, swelling of tongue, persistent cough within 5 minutes of vaccination. Was treated with EpiPen and kept in ER for observation overnight. Symptoms resolved.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Famotidine, Protonix",,GERD,,"Allergy to sulfa, latex, bee-stings","['Cough', 'Dyspnoea', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 926043,NM,49.0,F,"rt. orbital numbness, lip numbness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,None,None,No,,Bactrim Strawberries,"['Hypoaesthesia eye', 'Hypoaesthesia oral']",2,PFIZER\BIONTECH,IM 926044,FL,55.0,F,"Vaccine administered at 11:15 AM. At 12:00 pm the top of my head became very hot, my face felt hot and red with raised rash, my scalp became very itchy, my heart felt like it was beating out of my chest and I had pounding in both ears. My bilateral forearms began to itch and then developed hives. I notified my Supervisor that I was having a reaction. I was checked in to ER (where I am an RN). My blood pressure was elevated 180's systolic and my heart rate was 180BPM and short of breath. An IV was started and I was given Normal Saline Bolus, Solu-medrol 125MG and Benadryl 25MG IV. Prior to medications, my throat felt itchy and ""tight"" but resolved once medication given. The itching and hives continued to spread to my upper back, neck, bilateral feet and behind my bilateral knees. After approximately 1 1/2 hrs itching and hives continued then I was given Pepcid IV and Benadryl 25mg PO which after 40 minutes my itching and hives resolved. I was later discharged home with a prescription of Methylprednisolone 4MG dose pack. Symptoms resolved until approximately 1:30 am on 5/7/2021 when I awoke to pounding in my ears and the feeling once again my heart was beating out of my chest. My heart rate was 132BPM, I became hot and diaphoretic, short of breath. My scalp felt it was on fire and then I broke out in hives. I immediately took Prednisone, benadryl and pepcid. I took a cool shower, got dressed and drove to the hospital down the road and sat in the parking lot just in case my throat became itchy and tight (which it did not). The hives and itching began to resolve after an hour. My heart rate went back to 67BPM and shortness of breath resolved as well. I called Employee Health at hospital and made a report of symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Vyvanse 40Mg 1 tab daily AM, Fluoxetine 10MG 1 tab daily HS , Estra 0.5mg/Noreth 0.1mg 1 tab daily , Tizanidine 2mg (PRN)",,ADHD,Shingle Vaccine 2018 unknown mfg etc. I had hives/itching at inj site,"Codeine, Morphine, Statins including Zocor, Pineapple, Green peppers","['Blood pressure increased', 'Dyspnoea', 'Erythema', 'Feeling hot', 'Hyperhidrosis', 'Laboratory test normal', 'Palpitations', 'Pruritus', 'Rash', 'Rash papular', 'Skin burning sensation', 'Skin warm', 'Throat irritation', 'Throat tightness', 'Urticaria']",1,PFIZER\BIONTECH,IM 926045,VA,31.0,F,7 days after injection. Developed large irregular oval shaped irritation/reaction at site of injection. Skin was Red. Hot to touch. Raised. Hardened/thickened tissue. Size 11 cm x 5 cm. Itchy face two-three days prior to reaction at arm. Minimal itchiness at injection site or reaction,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/06/2021,8.0,OTH,None,None,None,,None,"['Injection site erythema', 'Injection site induration', 'Injection site irritation', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Pruritus']",1,MODERNA,SYR 926046,OH,48.0,F,"general fatigue, body aches, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Fatigue', 'Nausea', 'Pain']",1,MODERNA,IM 926047,PR,28.0,F,Left axilar pain ( lymph nodes inflammation).,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/03/2021,6.0,WRK,,,,,,"['Axillary pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 926048,PA,59.0,F,"Patient's states that she woke up at 3 am on 1/7/2021 with left sided facial swelling and lip swelling and she went back to sleep and woke up again around 5:30 am and swelling had gone down, and then at 10:30 am patient reports that left facial swelling and left lip swelling completely resolved. Pt. denies taking anything to resolve swelling of left face and lip.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,"yes- spironolactone 25 mg po twice daily, atorvastatin 80 mg po daily, fosinopril 40 mg po daily, pramiprexole 0.25 mg po daily, aspirin 81 mg once daily, metoprolol tartrate 25 mg po twice daily, vitamin d/calcium, vitamin c 500 mg po dail",denies,denies,,denies,"['Lip swelling', 'Swelling face']",1,PFIZER\BIONTECH,IM 926049,CO,54.0,F,"1/7/20 circular redness, itching in upper left arm at injection site, not noticed previously.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/07/2021,9.0,PVT,levothyroxine,none,hypothyroid,,none,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 926050,AZ,52.0,F,She states that she is nauseous since the vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,,,,,,['Nausea'],UNK,MODERNA, 926051,IL,58.0,F,"""By around 7p that evening 12/17/20, i was unable to life my arm to undress. the next morning the injection site was a little tender but i could move the arm""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,,,,,Codeine,"['Injection site pain', 'Loss of personal independence in daily activities', 'Mobility decreased']",1,PFIZER\BIONTECH,IM 926052,MO,48.0,F,"Shortly after receiving the vaccine, the patient reported feeling flushed and hot with rash, shaking, shivering, and pain in upper chest, which the patient described as being normal because of her COVID pneumonia. I would rate the reaction as moderate. Diphenhydramine 25mg capsule was given by mouth, ice water was offered. Patient was closely monitored but no further intervention was necessary. After about 25 minutes, symptoms subsided and patient decided to leave.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Prednisone Recently received dexamethasone inj.,Said she was still COVID+ and was still experiencing a few symptoms from it. She said her physicians advised her to go ahead with the vaccine anyway. I advised of the potential for increased sensitivity to the vaccine because of the recent infection. She understood and consented anyway.,Environmental allergies of undisclosed type.,,Declared previous allergy immunotherapy but did not specify specific allergies.,"['COVID-19 pneumonia', 'Chest pain', 'Chills', 'Hot flush', 'Rash', 'Tremor']",1,PFIZER\BIONTECH,IM 926053,GA,40.0,F,Localized swelling/redness/warmth/soreness that started on the day after vaccine. I thought it was just a normal vaccine reaction because I have had those in the past. It seemed to get a little smaller and less red/warm in the next few days but then started to get more red and swollen in the past 24-48 hours. It has been a week since the vaccine. It is itching some now for the past 2 days as well.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,"Levothyroxine 50mcg, ashlyna",none,hypothyroid,,sulfa,"['Erythema', 'Pain', 'Pruritus', 'Skin warm', 'Swelling']",1,PFIZER\BIONTECH,IM 926054,OK,37.0,F,"Patient began to have tingling under her right eye and face, then she began to have a rapid pulse (156), she felt chest heaviness, contact clinic. Clinic suggested taking patient to the hospital to be evaluated. Patient decline the ride to clinic but stated she would have her spouse take her to the hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/28/2020,0.0,PUB,,,,,,"['Chest discomfort', 'Heart rate increased', 'Paraesthesia']",UNK,PFIZER\BIONTECH,IM 926055,NY,50.0,F,"Noticed a 2-3 inch hard, red itchy patch near injection site. Started on Day 8 post-vaccination. Used hydrocortisone 2.5% cream once. Resolving on Day 11 post-vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/04/2021,8.0,OTH,levothyroxine 125 mcg orally daily,,"thyroid cancer, hypothyroid",,sulfa iodine,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus']",1,MODERNA,IM 926056,KY,51.0,M,"Injected in the right arm. Woke up this morning to the right underarm lymph node swollen and tender to the touch. No redness, no rash, not warn to the touch. Fatigue and body aches also accompany the adverse effects this morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,Lisinopril Adderall,None,None,,None,"['Fatigue', 'Lymphadenopathy', 'Pain', 'Tenderness']",UNK,MODERNA,IM 926058,FL,21.0,F,"Localized redness in a circular shape at and surrounding injection site. Along with redness, the area of skin is itchy, raised, and hot to the touch. Symptom developed 7 days after receiving dose 1 of the COVID 19 Moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,Methylphenidate 20 mg Blisovi Fe 1.5/30 birth control pill,None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Local reaction']",1,MODERNA,SYR 926060,IL,30.0,F,"On 1/4/21 patient had itching to both hands(possibly from dry skin). On 1/6 patient stated her left hand swelled at around 1:00pm, then her first two fingers on her right hand swelled and first two fingers on her left hand were numb for approximately 45 minutes. Patient was seen by her primary care provider, no treatments have been done at this time. Dr. thought patient was having a systemic response when she woke up this morning (1/7/21) with no swelling or any other problems.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/06/2021,9.0,PUB,Emagality-for migraines Ativan- PRN (has not used in over 3 weeks),,Migraines,,Ceclor-hives Augmentin-hives,"['Hypoaesthesia', 'Peripheral swelling', 'Pruritus']",UNK,MODERNA,IM 926061,CO,33.0,F,"Pt. was vaccinated on 12/31/20 @ 11:07 a.m. with Moderna Vaccination. Pt. experienced some tingling on the tip of her tongue. She did not have any difficulty swallowing or breathing. She was noted to have some PVC's and because of the PVCs and the tingling in the tongue she was transported to the Emergency Room. Pt is 28 weeks pregnant with due date 03/24/21. Pt. was placed on heart monitor and noted to have PVCs , no runs noted.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,Triamterene Hydrochlorothiaz (Maxzide) Pre-Natal Vitamin,,Tinnitis,,No known allergies,"['Blood magnesium decreased', 'Cardiac monitoring', 'Exposure during pregnancy', 'Paraesthesia oral', 'Ventricular extrasystoles']",1,MODERNA,IM 926062,ND,25.0,F,"localized reaction- pain, redness, warm to touch, inflamation",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"venaflexine, aviane",sinus infection,none,,none,"['Erythema', 'Inflammation', 'Local reaction', 'Pain', 'Skin warm']",1,MODERNA, 926063,WA,56.0,F,1 week plus 1 day post vaccination my Left arm started to itch near the injection site and a red rash developed about 3 inch x 1 inch in size slightly below the actual injection point - it is still itchy and red my face also feels slightly flushed on and off,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,thyroid medication,,Hypothyroidism,,none none,"['Flushing', 'Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Rash erythematous']",1,MODERNA,IM 926064,IN,39.0,F,"At approximately 3am (11 hrs after vaccine), had chills, body aches, severe headache, dizziness. Chills lasted about 4-5 hours, body aches x 24 hrs, and headache 24 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Spironolactone 50 mg QD for acne Microgesting FE 1.5/30 for acne,None,None,,Benzyl Peroxide,"['Chills', 'Dizziness', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 926065,OH,39.0,M,"CLIENT WITH STATED HISTORY OF VASO-VAGAL REACTIONS TO ""STRESS"" . RECEIVED VACCINE- IMMEDIATE NO REACTION- TO OBSERVATION AREA- 5 MIN. LATER, BECOMING DIZZY, NAUSEATED, PALE. MOMENTARILY LOSS OF CONSCIOUSNESS. DIAPHORESIS. BP 120/60. PLACED ON COT WITH LEGS ELEVATED. COLOR RETURNED OVER 30-40 MIN. NAUSEA LESSENING; 12/30/2020- AGAIN SPOKE WITH CLIENT- OCCATIONAL WEAKNESS, SWEATY , VERY MINIMAL DIZZINESS WITH EXERTION. MILD LETHARGY- ALL STAYING SAME. REPORTING ON CDC-VSAFE SITE.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/26/2020,0.0,PUB,UNKNOWN,UNKNOWN,UNKNOWN,"SAME VASOVAGAL SWEATY, DIZZINESS, PALE",UNKNOWN,"['Asthenia', 'Dizziness', 'Hyperhidrosis', 'Lethargy', 'Loss of consciousness', 'Nausea', 'Pallor']",1,MODERNA,IM 926066,NC,63.0,F,?Moderna COVID?19 Vaccine EUA?,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,WRK,,,,,,['Unevaluable event'],1,MODERNA,IM 926067,CO,32.0,F,Large lump on right delt- Elbow to shoulder Fever Bodyaches Rash on Face and Chest,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,,,,,Dilaudid Pumpkin Nickle,"['Injection site mass', 'Pain', 'Pyrexia', 'Rash']",1,MODERNA,IM 926068,AZ,50.0,F,"COVID symptoms - fever, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,,,,,,"['Fatigue', 'Pyrexia']",UNK,MODERNA, 926069,NJ,54.0,F,Patient felt numbness around her nose and lips about 2 hours post vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,"Amlodipine 5 mg, Atorvastatin 40 mg, Losartan/HCTZ 100-25 mg, Vitamin D",,"Hypertension, hyperlipidemia, obesity, prediabetes",,Penicillin,['Hypoaesthesia'],1,MODERNA,IM 926070,FL,39.0,F,"Yesterday was day 8 and i woke up with my arm hot, itchy, red and had a welt about 2 inches round. its gotten slightly bigger today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,WRK,"baby aspirin, birth control, multi vit, zinc, vit c, quercetin, zyrtec, magnesium",,,,sulfa and piroxicam enviromental allergies,"['Erythema', 'Pruritus', 'Skin warm', 'Urticaria']",UNK,MODERNA,IM 926072,PA,38.0,F,"Metallic taste in mouth, tingling in tongue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Dysgeusia', 'Paraesthesia oral']",1,MODERNA,IM 926073,NE,85.0,F,Swollen red rash at injection site and running down the interior arm to elbow. Itching with spreading over 2-3 days. Needed to take Benadryl at night for past 3 nights.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PUB,"Metoprolol, and Diazide",,Did have Covid-19 in October of 2020,,,"['Injection site rash', 'Injection site swelling', 'Pruritus', 'Rash erythematous']",1,MODERNA,IM 926074,LA,41.0,F,"Around midnight on 1/7/21, I started to have a pain in my left arm. It hurts to move my arm. The pain included the entire left side of the arm above the elbow, including the bone and muscle pain. At 8 am- 12:45 pm on 1/7/21, I put an ice pack on the injection site and it provided no relief. I took a Tylenol at 11:45 am and it brought the pain level down from a 7 to a 6. I took a picture this morning of the site and there is a little swelling at injection site, almost looks like a rash, and the area is extremely tender to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2020,01/07/2021,367.0,OTH,"Losartan, amlodipine",N/a,Hypertension,,Azithromycin,"['Injection site pain', 'Injection site rash', 'Injection site swelling', 'Pain']",1,MODERNA,IM 926075,GA,54.0,F,"Received the vaccine on 12/30/2020, I had sore arm and slight itchy arm for 2 days. On 1/6/21 my arm started feeling itchy, a slight burn and turned red around the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PUB,Valsartan-hctz 160-25 mg Sertraline hcl 25 mg Alprazolam 0.5 mg,none,high blood pressure,,none,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Pain in extremity', 'Pruritus']",1,MODERNA,SYR 926076,KS,30.0,F,"Fever for 8 hours with max 101.7, Tylenol taken x2 doses Chills and body aches for 30 hours Sore arm for 60 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/20/2020,1.0,OTH,Prenatal vitamin Norethindrone,None,None,,None,"['Chills', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 926077,TX,22.0,F,"Employee contacted Employee Health on 01/05/2021 after receiving COVID vaccine #1 complaining of cough, sinus headache, redness and streaking across eyelids, congestion, facial swelling that spread down her cheeks and chin area - took OTC Benadryl, fell asleep, and when she awaken, swelling to face had worsened - went to ER",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,unknown,unknown,none,,none,"['Cough', 'Erythema of eyelid', 'Eyelid disorder', 'Respiratory tract congestion', 'Sinus headache', 'Swelling face']",UNK,PFIZER\BIONTECH,IM 926078,GA,38.0,F,After leaving the facility the pt. returned and advised she was having chest tightness and dizziness. After sitting at the site for approximately one hour pt. advised still having what she described as chest tightness. Pt. was given 25mg Benadryl PO taken on scene. Pt. was healthcare worker and was advised to seek further medical attention if symptoms persist.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,Unknown,Unknown,None,,None,"['Chest discomfort', 'Dizziness']",1,MODERNA,IM 926079,CA,32.0,F,"Fever 101.9F, chills, fatigue, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/06/2021,3.0,PVT,none,none,none,,none,"['Chills', 'Fatigue', 'Headache', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 926081,MA,51.0,F,"severe red rash/hives on bilateral arms. Very itchy. spread drom hands up to shoulders, Benadryl and Prednisone taper",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,"Lisinopril, Breo-eplita, atorvastin, Vitamin 2, daily vitamin, Xyzol, Paroxetine",none,asthma,,"Bees, penicillin, Amoxicillin,sulfur, Keflex, poison ivy","['Rash', 'Rash erythematous', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 926082,AZ,71.0,F,"She had a fever, fatigue and some shortness of breath",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,,,,,,"['Dyspnoea', 'Fatigue', 'Pyrexia']",UNK,MODERNA, 926083,AR,47.0,F,"knot on right side shoulder blade...not hard, feels like fluid is in it. pain and discomfort under arm on right side",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,OTH,,shingles,,,penicillin,"['Axillary pain', 'Nodule']",1,PFIZER\BIONTECH,SYR 926084,MD,61.0,F,Within several minutes after receiving the vaccine she began experiencing chest tightness. She was given oxygen and benedryl but the chest tightness worsened and EMS was called. She was transported to the ED.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,,,,,['Chest discomfort'],1,PFIZER\BIONTECH,IM 926085,FL,69.0,F,"""bad taste in mouth, tongue feels funny, numb."" B/P 102/60 P 68",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,None,,Augmentin,"['Hypoaesthesia oral', 'Paraesthesia oral', 'Taste disorder']",1,PFIZER\BIONTECH,IM 926086,IN,28.0,F,"1 week and 2 days later my arm where the injection was given is red, painful, swollen, warm to the touch, and itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,UNK,Vitamin D and b12,Na,Asthma,,Na,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 926087,KS,30.0,F,"Chills and body aches, 30 hours Fever, 8 hours, max 101.7, Tylenol Soreness and injection site, 48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,WRK,Prenatal vitamin Norethindrone,None,None,,None,"['Chills', 'Injection site pain', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 926088,UT,24.0,F,"Complaining of rubber taste in throat after receiving 1st shot. Pt vitals remained stable throughout RRT. Pt released back to work, advised to come to the ED if symptoms worsened or persisted.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,,,,,latex and bleach- dermatitis,['Taste disorder'],1,PFIZER\BIONTECH,IM 926089,CA,57.0,F,Complained of tingling of the lips and felt very nervous. Was assessed and BP and pulse were normal. Has hx of anxiety. Pt reassured and monitored for 1 hour and then left after reporting that she felt better. She texted back at 3 pm when she got home and said she was feeling better. Took Allegra at home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,"Meloxicam, B12, C, D, Mag, turmeric, bromelain",Bike injury.,n/a.,,n/a.,"['Nervousness', 'Paraesthesia oral']",1,MODERNA,IM 926090,UT,23.0,F,"I received my first dose of the Moderna vaccine on 12/28/2020. On 01/04/2021 night, I had a red lump on the injection site that was slightly itchy. The following day, the lump was still there, it was red and hot, but not painful. The redness had spread towards my chest but did not go past my armpit. The size of the lump has decreased since then, nearly gone today on 01/07/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/05/2021,8.0,UNK,None,None,None,,None,"['Erythema', 'Injection site erythema', 'Injection site mass', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 926091,OH,39.0,M,Moderna COVID-19 Vaccine EUA I contracted COVID-19 on 11/24/2020. I received the first dose of the Moderna COVID-19 vaccine around 9:40AM on 1/6/2021. At around 9:45PM on 1/6/2021 I started to feel very nauseous and vomited twice within the hour.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,None.,None.,None.,,None.,"['Nausea', 'Vomiting']",1,MODERNA,SYR 926092,MS,45.0,M,"Presented to the ED with a chief complaint of LUE pain. Patient recently received the COVID-19 vaccine and is now experiences some redness, swelling and pain to the area which started about 7 hours after vaccine administration. Skin is also warm to the touch. He called his PCP who advised taking antihistamines and icing the area. Patient received single oral doses of both cephalexin 500 mg and diphenhydramine 25 mg in the ER at 1020 on 1/7/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Cetirizine 10 mg PO Daily Ondansetron 8 mg PO Q6H prn N/V Promethazine 25 mg PO Q6H prn N/V Pseudoephedrine 30 to 60 mg Q4H prn congestion Rizatriptan 10 mg BID prn headache Rosuvastatin 20 mg PO Daily,"12/13-12/17: Presented to outpatient clinical with severe headache, SOB, fatigue and chest pain. Was negative for COVID, flu and strep even with repeat testing. Received treatment for bacterial sinus infection which included 10 days of cephalexin 500 mg PO TID and 3 doses of IM ceftriaxone on different days. Patient suspects he was truly positive for COVID.",GERD Sleep apnea Cholecystectomy (09/17/2020),,Codeine - N/V Hydromorphone - N/V,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 926093,UT,34.0,M,"I got the 1st dose of the Moderna vaccine on 12/28/2020. 7-8 days later I started feeling itchiness. Rash was red, warm to the touch, and after a couple of days it spread. At least 6 co-workers also expressed the similar symptoms 7-8 days later after administration of the shot. No treatment done except for use of heating pad for one night. Will set up a doctor's appt.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,WRK,none,none,none,,none,"['Pruritus', 'Rash erythematous', 'Skin warm']",1,MODERNA,IM 926094,RI,52.0,F,"Day 3 bilateral swollen glands with bilateral ear pain Resolved by day 5 Day 9 Left arm redness (like 1st degree burn) swelling, pain/itching along whole upper arm and bicep area to the present. Taking Zyrtec daily",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/29/1920,,OTH,"Metropalol, Zyrtec",Hx. Epstein Barr Syndrome,HTN Seasonal allergies,,"Tegretol, eggs, and cats","['Ear pain', 'Erythema', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Lymphadenopathy', 'Pain in extremity', 'Peripheral swelling', 'Pruritus']",1,MODERNA,IM 926095,NJ,39.0,F,"When I got my first shot of the vaccine , I had some of the symptoms mentioned including a headache but after 24 hours , everything went away, however a few days after after , my headache Came back and has not gone away ever since , yesterday , I went to get my second vaccine but thankfully my headaches haven?t gotten worst.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/21/2020,5.0,PVT,Omega 3 Shark cartilage tablets Selenium Vitamin b complex Vitamin c Zinc Vitamin d Multi vitamin Biotin gummies for hair and nails,None,Chocolate cyst to my left ovary,,None,['Headache'],1,PFIZER\BIONTECH,IM 926096,NY,44.0,F,"According to patient on 1/6/21 around 9:00 PM,, one week post 1st dose Moderna injection, left arm injection site started to itch. On the morning of 1/7/2021, patient noted site was red, warm and tender to touch. Reported to RN and MD and observed erythema approximately 1 "" circle around injection site, warm to touch with slight swelling. Itching somewhat subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,OTH,"Multivitamin, Ibuprofen prn",No,Degenerative osteoarthritis,,Demerol,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 926097,CA,31.0,F,"Body Aches, Chills, Fatigue, Headache, Cough, stuffy nose",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,Just Birth Control,None,None,,None,"['Chills', 'Cough', 'Fatigue', 'Headache', 'Nasal congestion', 'Pain']",UNK,MODERNA, 926098,OR,46.0,F,"Patient while waiting after receiving her second COVID Vaccine dose started to feel short of breath, anxious and shaky. She was taken to the ED, where they took a set of vitals, listened to her lungs (clear) and completed an EKG.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Mirena,None,None,,"Acetaminophen, Amoxicillin, Hydrocodone-Acetaminophen, Simvastatin, Oxycodone-Acetaminophen","['Anxiety', 'Dyspnoea', 'Electrocardiogram normal', 'Nervousness', 'Vital signs measurement']",2,PFIZER\BIONTECH,IM 926099,WI,53.0,F,"Felt like skin, head to toe was ""on fire"" and mild hives (burning- similar to past reactions with things) - I took 50mg benadryl [I have an epi pen but chose to try benadryl first as my symptoms were only skin and I was breathing fine (pulse ox was 98 which is normal for me); also had racing heart and was only a little above my norm of 80's -90's, but did not feel PVCs or irregularity, aches, chills, fatigue, eye pain, severe headache on weds night night and thursday; drove 2 hrs home to cabin for new years the next day on thursday (new years eve) (I am working for COVID - epidemiologist, retired nurse), aches, cold/chills/severe headache remained (took 1000 of tylenol in the morning and then before going to bed that night); in bed at 2000pm because I was so tired and felt ""sick."" the next day I had no symptoms when I woke up. My arm was not even hardly sore in the two days that I did not feel bad; I could feel the injection but it was not painful like previous vaccines that I had received. Before the vaccine I called my ex housemate who is a trauma nurse practitioner and she advised me to take tylenol and not aspirin after I get the vaccine; I did not administer 1000mg tylenol and benadryl (50mg) to myself until bedtime that even after my symptoms began)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,UNK,"levothyroxine, acyclovir, fluoxetine, serevent, qnasl, Flovent, singulair, vitamin D3, vit b12, MVI women's",none,"hashimotos thyroiditis (hypothyr); chronic HSVI; recurrent shingles, asthma (RAD/EIA), menopause",Military - bootcamp,"molds, ash trees","['Chills', 'Fatigue', 'Feeling cold', 'Headache', 'Malaise', 'Pain', 'Pain in extremity', 'Palpitations', 'Skin burning sensation', 'Urticaria']",1,MODERNA,IM 926100,PA,40.0,F,"Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at injection site, and then swelling and tingling in left hand. and head ache. Symptoms didn't subside until day 3. Still have pain in left arm that radiates down to elbow. All other symptoms subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,Levothyroxine 25MCG Adderall 30mg Cyanocobalamin 1000MCG/ML,none,Hypothyroidism ADD/ADHD Vit D deficiency Anatomical Narrow Angle Glaucoma Migraines,,Adhesive tape: rash Codeine Sulfate: Itching Dilaudid: throat swelling Mucinex: vomiting,"['Headache', 'Injection site swelling', 'Myalgia', 'Pain in extremity', 'Paraesthesia', 'Peripheral swelling']",1,PFIZER\BIONTECH,IM 926101,IL,54.0,F,"Within 30 minutes of receiving the vaccine, I experienced mild chest tightness and a mild cough. Later that day I experienced fatigue, headache, and chills. The next day I felt like I had the flu but went to work anyway. I became lightheaded and nauseous at work and was sent home. I spent all day in bed with a fever of 100 degrees, chills, and fatigue. The fever persisted until about 10 pm, at which time I began to feel better. My arm is also extremely red and sore at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Lisinipril, Diltiazem, Aleve",None,Elevated blood pressure,,Augmentin,"['Chest discomfort', 'Chills', 'Cough', 'Dizziness', 'Fatigue', 'Headache', 'Impaired work ability', 'Influenza like illness', 'Injection site erythema', 'Injection site pain', 'Nausea', 'Pyrexia']",1,MODERNA,IM 926102,OR,31.0,F,"VACCINE ERROR: First dose of COVID-19 vaccine (PFizer, lot EJ1865) was given on 12/20/2020. The second dose was given on 1/5/2020 (16 days after initial dose). No adverse reaction was noted at the time of this submission",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Inappropriate schedule of product administration', 'No adverse event']",2,PFIZER\BIONTECH,IM 926103,NY,38.0,F,"According to patient on 1/6/21 around 11:00 PM, one week post 1st dose Moderna injection, right arm injection site started to itch. On the morning of 1/7/2021, patient noted site was red, warm and tender to touch. Reported to RN and MD and observed erythema approximately 1/2 "" circle around injection site, warm to touch with slight swelling. Continues to itch. Patient was pre-medicated with Benedryl 50 mg. po.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,OTH,"Vitamin C & D, Protonix, Allegra, Singular",none,none,,"Walnuts, Flu vaccine, Sudafed","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 926104,MA,45.0,F,"One week after vaccine was administered, red rash appeared in area below injection site. Itchy but does not require medical attention.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PUB,"Ocella, general multivitamin",none,none,,shellfish,"['Injection site rash', 'Pruritus', 'Rash erythematous']",1,MODERNA,IM 926105,GA,25.0,F,"vaccine administered at 12:18pm, client ambulated to observation area. @12:23pm client complained of nausea and vomiting, redness noted to chest and neck. Client given 20ml Benadryl PO*1 @ 12:27pm. Client moved from chair to floor @ 12:34pm. Client complained of tightness in chest, lungs clear no wheezing noted. 0.5mg Epi administered RT @ 12:33pm. 911 called at 12:32pm, arrived @ 12:42pm. Client alert and oriented to person, place and time. Redness centralized to chest and neck, not noted on abdominal area or arms. Client transported to local hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,,,,,"Penicillin, Amoxicillin, HCTZ, Augmentin Bromfed DM","['Chest discomfort', 'Erythema', 'Nausea', 'Vomiting']",1,MODERNA,IM 926107,NY,32.0,F,"According to patient on 1/6/21 around 400 PM,, one week post 1st dose Moderna injection, right arm injection site started to itch. On the morning of 1/7/2021, patient noted site was red, warm and tender to touch. Reported to RN and MD and observed erythema approximately 1 "" circle around injection site, warm to touch with slight swelling. Itching somewhat subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,OTH,None,None,None,,None,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 926108,WY,22.0,F,"Shortness of breath, body ache, headache, sore scratchy throat, chest pains, vomiting and nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Hailey birth control,Covid-19 11-16-20 to 12-7-20,None,Light headed after penicillin,Sulfa,"['Chest pain', 'Dyspnoea', 'Headache', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Throat irritation', 'Vomiting']",UNK,MODERNA,IM 926109,KS,49.0,M,"Moderna COVID-19 Vaccine EUA I developed a hard red and warm welt on my arm approx 3cm x 4 cm in size about 2 hours after the vaccinatin. 48 hours later there is still a red , warm and hard area at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,MAGNESIUM LOSARTAN EFFEXOR ASPIRIN IRON MIDAMOR VITAMIN C VITAMIN D PRAVASTATIN,NONE,MIGRAINES HTN HYPERLIPIDEMIA,,CT CONTRAST MORPHINE,"['Erythema', 'Induration', 'Injection site erythema', 'Injection site induration', 'Injection site warmth', 'Skin warm', 'Urticaria']",1,MODERNA,IM 926110,IA,44.0,F,tingling in both hands - along ulnar nerve to 4th/5th fingers - severe - reports 8/10 discomfort BILATERALLY - felt like she was going to pass out and have diarrhea and vomit at same time - these symptoms awakened her from sleep at 11:45pm; sxs lasted about 15 minutes and then abated; tingling in 4th/5th fingers BILATERALLY persists today- though much less intense - reports at level of 1/10; never did vomiting and never had diarrhea; never passed out; feeling well today - able to run 4 miles and teach yoga and work at a physical therapist,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,none,no,no,,lactose latex,"['Discomfort', 'Dizziness', 'Nausea', 'Paraesthesia', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 926111,NY,65.0,F,"Moderna COVID-19 Vaccine EUA On the 7th day after the inoculation I woke up a with a headache and swelling under my left arm, in the lymph nodes. The nodes were quite tender (hard) to the touch as was the area around them. No fever or chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/07/2021,9.0,PUB,,,,,,"['Headache', 'Induration', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 926113,IN,54.0,F,"Low Grade fever temp 100.0, Body aches and joint aches, fatigue,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Levothyroxine 225mcg,No,Thyroid cancer 9 years ago,,"Bananas, Cipro, Latex, Penicillin, Compazine, Clindamycin,","['Arthralgia', 'Fatigue', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 926114,NY,41.0,F,"Itchy Vesicular rash on arms, legs, abdomen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/04/2021,2.0,PVT,HCTZ Nifedipine,Poison ivy 12/27,CHTN,,"Cat, dogs, horses, hay fever","['Rash', 'Rash pruritic', 'Rash vesicular']",1,MODERNA,IM 926115,TX,54.0,F,"On day one, I felt the typical soreness to site. Starting day 2, a headache presented. Starting day 3, in addition to the headache, fatigue, body aches and a knot and soreness at the site. It is day 9 now post... and body aches & fatigue continue. In addition, the injection site is inflamed (swollen, red and hot). I am an RN and one of the docs I work with suggested I may have possible cellulitis at the site and I need to watch it for worsening.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PVT,"NP Thyroid, multi-vitamins, Vit D3",none,hypothyroid,,none,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site inflammation', 'Injection site nodule', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Pain']",1,MODERNA,IM 926116,NJ,27.0,F,I didn't have an adverse reaction until 6 days after the injection. The injection site became red and swollen and my whole body has been itching for 2 days now since 1/05/2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PVT,Lo loestrin fe,,,,penicillin and dairy products,"['Injection site erythema', 'Injection site swelling', 'Pruritus']",1,MODERNA,IM 926117,NV,34.0,F,Patient received dose #1 of Moderna Covid vaccine at about 8:15am at a mass vaccination event for Tier 1 recipients. Within 3-5 minutes the female patient reported a sensation of her throat being swollen and reported mild difficulty breathing. She was noted to be mildly tachypneic and tachycardic. Patient was observed over the next few minutes. She was diaphoretic and reported her symptom of difficulty breathing was getting worse. Oxygen at 2-3 liters per minute was administered. BP 170/95. Epinephrine 0.3mg was subcutaneously administered at 8:27am. 911 was called. Patient reported improvement in symptoms within one minute of receiving the epinephrine. Oxygen and monitoring continued. Patient remained tachycardic but her respiratory rate decreased and her diaphoresis improved. Paramedics arrived at about 8:40 am and patient was transported via ambulance to ER in stable condition.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,Latex,"['Dyspnoea', 'Hyperhidrosis', 'Pharyngeal swelling', 'Tachycardia', 'Tachypnoea']",1,MODERNA,IM 926118,OH,35.0,F,"Patient notified the pharmacist who administered the vaccine on 1/6/21 stating presence of a nodule/bump, tenderness and warmth at the injection site. The pharmacist advised to seek medical advice in case of infection. Patient says the provider recommended to monitor for now and thinks it may be an allergy. Pharmacist will continue to follow up with patient to make sure symptoms are improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,PVT,,,,,,"['Injection site nodule', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 926119,MA,58.0,F,Raised rash on right arm at and around insertion site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,One a day vitamin,none,none,,none,"['Injection site reaction', 'Rash papular']",1,MODERNA,IM 926120,LA,31.0,M,"I had general symptoms of covid-19. Fatigue, loss taste and smell.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/22/2020,5.0,WRK,Lexapro,None,None,,Shellfish,"['Ageusia', 'Anosmia', 'COVID-19', 'Fatigue', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 926121,CA,51.0,F,"L hand felt sweaty and arm ""felt numb"" at 10:25AM. Vital signs are as follows: P 105 BP 140/88, O2sat 100% T 99.6. Grip strength WNL and no deficits noted on exam. No adverse reactions to previous shots or similar event happening in the past. Repeat VS P 100 BP 158/82 O2sat 100",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,"metformin XR, pravastatin, singulair",,DM2,,NKDA,"['Hyperhidrosis', 'Hypoaesthesia']",1,MODERNA,IM 926122,NY,50.0,F,"Pfizer Vaccine 45 min after dose, needed to clear my throat allot. Took Claritan and quieted down. By 8 pm left side neck ache. By 3 am the next day lots of trouble with throat and swallowing. Moderate to sever neck pain, muscle tight and contracted like cervical dystonia. Took another claritan. 2 hours later 25 mg Bendadryl. 830am called healthcare clinic and was seen. ""Immune response"" Not ""allergy"" Recommends not getting shot number 2",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,none,none,"chronic viral infections EBV, Herpes",Egg postive flu shot-Sever coughing for months,"Compazine, Phenergan, Ultram, Sulfa, eggs, casein, gluten","['Muscle tightness', 'Neck pain', 'Pharyngeal swelling', 'Throat irritation']",1,PFIZER\BIONTECH,IM 926123,CA,66.0,F,"Had initial redness, swelling and pain at injection site. Resolved after 2-3 days, then mildly itchy. One week later, swelling, pain, itching have recurred. Day 8 with 5x8 cm red, tender, itchy swelling left deltoid at injection site. Unexpected after reviewing published side effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,OTH,"Pradaxa 150 mg bid, Advair inhaler BID, Centrum multivitamin, Vit. D, Gulcosamine",DVT 12/22/20,None,,"Possible rash with Ampicillin 30 years ago, seasonal allergies","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Pain', 'Pruritus', 'Swelling']",1,MODERNA,IM 926124,OR,24.0,F,"01/06/2021 Due to Lisinopril allergy, patient observed for 30 minutes after vaccination. As she was leaving, patient stated her throat felt dry and stratchy. Patient denied shortness of breath, rash, hives, dizziness, headache, and nausea. Patient escorted to Dr. for evaluation and management. Dr. ordered 25mg Benadryl PO, medication was administered at 1528 and patient was monitored by medical staff. Patient reports feeling much better at 1615. 01/07/2021 0810 Patient reports all symptoms resolved on 01/06/2021 by 2000.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Unknown,Unknown,Unknown,,Lisinopril,"['Dry throat', 'Oropharyngeal discomfort']",1,MODERNA,IM 926125,NY,29.0,F,"in the subject's own words: I received vaccine on 12/28. on Monday 1/4 I noticed the site of injection was reddened and raised along with mild itching. on 1/6 the redness is twice the size. Patient spoke face to face with subject and another pharmacist together on 1/6. Subject reports it is not painful. she tried ice and she tried benadryl but neither really helped. She showed it to Doctor who described it as erythema but not cellulitis. It is approximately 7 inches in length. on 1/7 she reports it is the same size, less red, not warm and minimal itch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,Not recorded at this visit,Not recorded at this visit,Not recorded at this visit,,Not recorded at this visit,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 926126,MS,53.0,M,"Headache, chills, fever 99.3, nausea, severe arm pain, tired, sleepy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Vitamin C, Jardiance, Trulicity, Crestor, Carvedilol, Lisinopril, 81mg aspirin",no,"diabetes, 5 heart stents, high blood pressure.",tetanus as a child,"Levaquin, metformin, tetanus,","['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Somnolence']",1,MODERNA,SYR 926127,DE,56.0,U,"Patient states ""On Tuesday 1/5/21 around 11:30 a.m. I started feeling sick like I had the flu. I had muscle aches, fatigue, shortness of breath, headache, nausea and diarrhea. The only thing I didn't have is the fever."" Patient seen her primary health provider on Wednesday 1/6/21 who listened to her lungs and just told her to take it easy. Patient is currently working from home",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,,,UNK,,,,,,"['Diarrhoea', 'Dyspnoea', 'Fatigue', 'Headache', 'Influenza like illness', 'Malaise', 'Myalgia', 'Nausea']",1,MODERNA,IM 926128,NY,23.0,F,Neon yellow urine.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/04/2021,1.0,PVT,,,,,,['Chromaturia'],1,PFIZER\BIONTECH,IM 926129,PA,38.0,F,"I received my vaccination on December 29, 2020. January 7, 2021, at around 4:00am I woke up and my injection site had become itchy, hard and hot to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/07/2021,9.0,PVT,"Prozac- 20 mg, Align probiotic, vitamin D3",None,None,With the flu shot but it was right after the injection.,None,"['Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,SYR 926130,CA,38.0,F,"She had a vaccine on 12/24 and was fine. On 12/31 she had onset of hives on the Left arm below the injection site . She was seen twice in the ED , was given a course of Keflex In case it was developing cellulitis- however was told it was likely a delayed reaction. For the next few days she had tingling and pin in the arm. She is now feeling fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/07/2021,14.0,PVT,None known,none known,none,,"Iodine, Seafood","['Injection site urticaria', 'Paraesthesia', 'Skin reaction']",1,MODERNA,IM 926131,OH,22.0,F,"Client advised that after about 10 minutes of receiving vaccine, she started with headache and pain in middle-upper back. Her BP was 120/69 with HR of 92.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,Unknown,Unknown,Unknown,,None,"['Back pain', 'Headache']",1,MODERNA,IM 926132,VA,23.0,F,"Itchy, red painful area with blisters near site of injection. Started 1/6/2021 and progressively has gotten worse.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/06/2021,8.0,WRK,,,PCOS,,,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site vesicles']",1,MODERNA,IM 926133,WI,44.0,M,"Patient had a flu shot (Fluzone Quadrivalent, P-Free)(Lot: UJ471AA) on 12/29/2020 and was given the Moderna vaccine (Lot: 011L20A) on 1/5/2021. Patient has been notified and is aware. Patient is currently not experiencing any symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,,,,,,"['Contraindication to vaccination', 'No adverse event']",1,MODERNA,IM 926135,CA,35.0,F,Headache Dizzy Nausea vomiting dry heaving,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,UNK,,,,,,"['Dizziness', 'Headache', 'Nausea', 'Retching', 'Vomiting']",1,MODERNA,SYR 926136,PA,53.0,M,"After receiving the shot I walked up to sit down in the bleacher seats, Talked to the doctoer to set up my reaction site and after he left I felt a wave of panic and felling that my breathing was suffering. Then felt tingleing in my tounge. Just feeling of breath issue. MY blood pressure was high a liitel bit 140-100 and my heart rate was 88.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,SCH,none,none,none,,none,"['Dyspnoea', 'Hypertension', 'Panic reaction', 'Paraesthesia oral']",UNK,MODERNA,IM 926137,ME,1.0,M,"Pt showed at the ER on 12/25/2020 after falling mid walk. Pt left hand was rhythmically opening and closing. Head was twitching and left arm and left leg twitching-sx lasted 10min. Fever of 103 documented by EMS, vaccines 1 wk prior to the ER visit. Sx resolved 2 hrs after seizure. Diagnosed with ? atypical febrile seizure. Patient then sent to Center where he had an EEG and neurology consult. Dx with complex febrile seizure- had felt possible febrile seizure vs epilepsy vs genetic predisposition secondary to TMPRSS3 genetic mutation.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,12/18/2020,12/25/2020,7.0,PVT,none,no- did have a fever,Deaf- has cochlear implant,,none,"['C-reactive protein', 'Differential white blood cell count', 'Dyskinesia', 'Electroencephalogram', 'Fall', 'Febrile convulsion', 'Full blood count', 'Metabolic function test', 'Muscle twitching', 'Pyrexia', 'SARS-CoV-2 test negative', 'Seizure']",1,MERCK & CO. INC.,SC 926138,,40.0,F,"Patient describe itching of back. Red, slightly raised rash noted across shoulders. Administered 25 mg Benadryl PO. Patient waited additional 20 minutes. Rash persists. Patient described sensation of slight itching on legs. Denies and shortness of breath or itching of throat. Patient advised not to drive if she felt any sleepiness. She verbalized understanding.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Pruritus', 'Rash erythematous', 'Rash papular']",UNK,PFIZER\BIONTECH,IM 926140,TX,63.0,F,"Within 8 hours of vaccine receipt, I began to experience left-sided tinnitus. During the first vaccination; I experienced muscle soreness at the site of injection; mild fatigue the next day (12/14/2020). After the second vaccine, I experienced increased muscle pain, with decreased ROM of the left shoulder due to pain. Within 12 hours, I experienced diffuse myalgias. After 16 hours, I experienced a fever (101F) with chills (resolved within 24 hours). There was significant fatigue the first 36 hours after the second vaccine administration. I took two doses of Tylenol on the first day. No rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,Losartan 25 mg daily Levothyroxine 100 mcg daily Aspirin 81 mg daily,none,Hypertension; hypothyroid,,shell fish erythromycin,"['Chills', 'Fatigue', 'Injected limb mobility decreased', 'Injection site pain', 'Injection site reaction', 'Myalgia', 'Pyrexia', 'Tinnitus']",2,PFIZER\BIONTECH,IM 926141,OK,49.0,F,"SWEATS, HEADACHE,BODY ACHES,CHILLS,TEMP .OF 101.1 ,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,SEN,ELDERBERRY. VITAMIN C,NONE,NONE,,NKDA,"['Body temperature increased', 'Chills', 'Headache', 'Hyperhidrosis', 'Pain']",1,PFIZER\BIONTECH,IM 926142,GA,38.0,F,"Pt in clinic for 1st COVID vaccination. Nurse reviewed screening checklist, nurse queried pt related to severe reactions to any injected medications or immunization previously. Pt denied any severe reaction history to injected medications or immunizations. Pt was administered COVID Pfizer injection approx. 0900. At approx. 0910 pt returned to nurses room reporting having stomach cramping. Pt reports attempted to use bathroom without success. Nurse notified Lead Nurse, NP. Emergency kit obtained, vital signs collected while Lead Nurse consulted Nursing Director, DNP, per consultation Lead Nurse contacted 9-1-1. Pt SpO2 stable in high 90's, pt did not present with difficulty breathing at that time, pt reported ongoing stomach pain and itching on abdomen. Pinprick petechiae observed on thoracic area, pt actively scratching. Per Lead Nurse, NP consultation with Nursing Director, DNP IM Bendaryl advised. Pt notified nurses of PMH allergy to Benadryl. Pt indicated when school-aged had anaphylactic reaction to penicillin and given IV Benadryl at that time, resulting in hives. Pt further reported allergic reaction to unknown facewash when 18 years old, when presented at MD office at that time was given IV Benadryl, subsequently sent to hospital at that time for severe reaction. Per consultation with Nursing Director epinephrine indicated. Nurse, RN administered epi-pen autoinjector 3mg at 09:22 (lot #G200810X, expiration 12/2021). Post epinephrine administration pt experienced nausea with vomiting and expressed feeling anxious. Pt affect became more somnolent with stomach upset. EMS arrived to clinic and pt consented to transport. Transfer of care to EMS approx. 09:45. RN",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,,,PMH Breast cancer with treatment with lymphnode removal and remission 2019,,"Benadryl, IV Penicillin facewash (unknown)","['Abdominal discomfort', 'Abdominal pain upper', 'Anxiety', 'Nausea', 'Petechiae', 'Pruritus', 'Scratch', 'Somnolence', 'Vital signs measurement', 'Vomiting']",1,PFIZER\BIONTECH,IM 926143,OK,29.0,M,Temp 99.4- 24 hours Short of breath - on going N/V - 3 days Productive cough. - on going Chills - 3 days Sweats - 3 days Headache- 24 hours Tiredness - 4 days,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,01/03/2021,13.0,WRK,,,,,,"['Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Influenza A virus test negative', 'Influenza virus test negative', 'Productive cough', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 926144,OK,77.0,M,"THE NIGHT OF VACCINATION DAY, RESIDENT BEGAN C/O SEVERE PAIN IN THE INJECTION ARM. THE DAY AFTER THE VACCINE, HE BEGAN HAVING MOOD ISSUES, VERBAL AGGRESSION/OUTBURSTS (ABNORMAL FOR THIS RESIDENT), DIZZINESS AND A SEVERE HEADACHE HE RATED AT 10/10 PER PAIN SCALE THAT DID NOT RESOLVE WITH SEVERAL DOSES OF PAIN MEDS.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,"BUSPAR, ASPIRIN, ZYRTEC, KLONOPIN, LASIX, GABAPENTIN, KEPPRA, TOPROL XL, REMERON, MULTIVITAMIN, PRILOSEC, PAXIL, PRAVACHOL, RANEXA, FLOMAX, VITAMIN B-1, VITAMIN B-12, TYLENOL, ANTACID SUSPENSION REG STRENGTH, GUAIFENESIN SYRUP, EXCEDRIN E.S",,"GEN ANXIETY DIS, DEPRESSION, HYPERTENSION, GERD, CAD, ANGINA, CONSTIPATION, HYPERCHOLESTEROLEMIA, NEUROPATHY, MOOD DIS, BIPOLAR MANIA, INSOMNIA, ERECTILE DYS, EXTRAPYRAMIDAL REACTION, SEIZURE DIS, BPH, ALLERGIC RHINITIS, CHF",,"PENICILLINS, SULFA ANTIBIOTICS, CIPROFLOXACIN","['Aggression', 'Anger', 'Condition aggravated', 'Dizziness', 'Headache', 'Injection site pain', 'Mood altered', 'Pain']",1,PFIZER\BIONTECH,IM 926145,TX,42.0,F,Mild axillary lymphadenopathy on left side ( same side as the site of administration) starting on day 9 progressing to mild lymphangitis by day 11 extending to mid arm. Resolved by day 20 without any treatment,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/29/2020,9.0,PVT,None,None,None,,None,"['Lymphadenopathy', 'Lymphangitis']",1,PFIZER\BIONTECH,IM 926146,MD,42.0,F,"Immediately after the vaccination she experienced chest pain, tachycardia, and throat tightness. She was given benedryl and epinephrine and EMS was called.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,Severely allergic to nuts and bees. She does carry an epi pen.,"['Chest pain', 'Immediate post-injection reaction', 'Tachycardia', 'Throat tightness']",1,PFIZER\BIONTECH,IM 926147,MA,45.0,F,"For the first few days: sore arm but was otherwise fine. About a week later, noted itching, redness, and swelling around the injection site. A couple days after that, developed general itchiness and some eye irritation; no rash or fever. Symptoms improving with antihistamine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/01/2021,4.0,UNK,,,,,,"['Eye irritation', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Pain in extremity', 'Pruritus']",1,MODERNA,IM 926148,TX,35.0,F,"severe back pain, headache, injection site reaction, fatigue, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Back pain', 'Fatigue', 'Feeling cold', 'Headache', 'Injection site reaction']",2,PFIZER\BIONTECH,IM 926149,TN,48.0,F,"Headache, soreness at injection site, extreme muscle aches and fatigue lasting from 12/25 to 12/30.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/01/2020,,WRK,,,,,,"['Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,SYR 926150,CA,40.0,F,GI upset with lower abdominal cramping and pain the two mornings after receiving the vaccine. Worse on day 2. Improved with eating.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,PVT,"multivitamin, probiotic, vitamin D3",none,none,,sulfa,"['Abdominal discomfort', 'Abdominal pain lower']",1,PFIZER\BIONTECH,IM 926151,VA,40.0,M,"shortly after receiving the vaccine (approximately 5-15 mins), patient developed a burning headache. Upon interview of patient, he states he had not had anything to eat or drink today and walked to this appointment (4 blocks approximately). Pharmacist monitoring patient noted the extreme heat in the room, gave patient water to drink, and walked with him in the hallway away from the hot room for about 30 minutes. Patient states he felt much better and reports his headache had improved enough to return home. Pharmacist had patient fill out safecare event for hospital reporting and gave patient numbers to call if feeling ill again.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Wellbutrin, Lexapro, amlodipine/benazepril at home; patient had taken Wellbutrin/Lexapro but had not taken his blood pressure medication (was due to take when he returned home around lunch)",none noted,"depression, hypertension",,none,['Headache'],1,MODERNA,IM 926152,NJ,56.0,F,"Headache, feeling chills and hot flashes, shortness of breath, rash on face, feeling ""mosquito bites"" all over body",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,PVT,"Sleeping medication, Xanax (as needed)",,,,"Ampicillin, seafood, lactose","['Chills', 'Dyspnoea', 'Headache', 'Hot flush', 'Paraesthesia', 'Rash']",1,PFIZER\BIONTECH,IM 926154,WV,46.0,M,"Fever, chills, soreness at injection site and muscle aches lasted about 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Chills', 'Injection site pain', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 926155,IN,25.0,F,"Headache, body/muscle aches, weakness, chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Zoloft 50mg Albuterol inhaler Melatonin 5mg,N/a,Asthma IBS,,N/a,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pain']",1,PFIZER\BIONTECH,IM 926156,KS,33.0,F,Felt sickly and had an anxiety feeling with a facing heart. Last a few hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Anxiety', 'Malaise', 'Palpitations']",1,MODERNA,IM 926157,WI,34.0,F,Erythematous rash that started 2 days after the vaccine in the area of injection and lasted 2 days; 1 week after injection developed hives over the injection site that resolved; 8 days-present blanchable erythematous rash surrounding injection site. No systemic symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,OTH,Flonase Allegra,None,Seasonal Allergies,,None,"['Injection site erythema', 'Injection site rash', 'Injection site urticaria', 'Pallor', 'Rash erythematous']",1,MODERNA,SYR 926158,NJ,49.0,F,"This was the vaccine recipient's 2nd vaccination. They had no issues with the 1st vaccination. Vaccine recipient reported that after 10 minutes of receiving the 2nd vaccine they developed a headache that felt like a migraine. The vaccine recipient took Advil, then a few minutes later started sweating, felt clammy, and hot. The symptoms started to pass 15 minutes later. That night they reported that their chest felt tight but it went away before bedtime. This morning 1/7/2021, vaccine recipient reported feeling tired and mind felt foggy. They were able to continue to go to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,Propanolol,None,None,,None,"['Chest discomfort', 'Cold sweat', 'Fatigue', 'Feeling abnormal', 'Feeling hot', 'Hyperhidrosis', 'Migraine']",2,PFIZER\BIONTECH,IM 926159,SD,38.0,F,"Received shot 12/23/2020 with only mild headache and tiredness the day following the shot. On 1/3/2021 to present I had swelling, redness and itching around injection site. On 1/6/2021 I had seemed medical assistance and was prescribed hydrocortisone 2.5%, Claritin, Pepcid and Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/03/2021,11.0,PVT,None,Mild headache and tiredness,Gastroesophageal reflux disease with esophagitis,Influenza vaccination,"Coconut, Hydromorphone, localized allergic reaction to flu shot","['Condition aggravated', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 926161,NV,31.0,F,"My injection site has become swollen (2cm diameter) itchy, warm, and red. This is above the dermis and just occurred today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,WRK,Ibuprofen Vitamin d Folic acid Iron infusion,,Anemia,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA, 926162,NJ,56.0,F,"headaches, hot flashes, chills, rash on face, feeling like ""mosquito bites"" all over body",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,PVT,"Xanax, sleep medications",,,,"Seafood, ampicillin, lactose","['Chills', 'Headache', 'Hot flush', 'Paraesthesia', 'Rash']",1,PFIZER\BIONTECH,IM 926163,NY,24.0,F,"Had fever of 102 since 5:30pm yesterday. Headaches, chills, and body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,no,COVID19 on Dec 2,no,"Flu shot, she had fever",no,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 926164,,52.0,F,"Raised, warm, hard lump on left arm at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,,,,,,"['Injection site induration', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 926165,IL,26.0,F,"fatigue and headache later in the evening of the vaccine, as well as the following day. +chills the following day. Symptoms improved day 3. Mild redness and swelling (3 cm induration) to injection site. Mild tenderness. COVID 19 test done on day 3 (day of office visit, test negative)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Chills', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site swelling', 'SARS-CoV-2 test negative', 'Tenderness']",UNK,MODERNA,IM 926166,PA,56.0,F,"Pt. states that she received vaccine and ten minutes after vaccination she started coughing, having tachycardia hr in the 110s, fullness feeling to head, chest irritation. Went to ER, discharged same day. On drive home she started having bilateral lower extremity weakness and felt super sleepy. 01/01/21 symptoms resolved. 01/02/21 woke up with chills at 2am, went back to sleep, woke back up at 5 am same day and symptoms resolved. 01/03/21-mild headache-took Tylenol sinus-headache resolved. Pt. states that she has felt fine ever since.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,"yes, hctz, atorvastatin, levothyroxine, hel and smoothe supplement",denies,"hypothyroidism, htn, high cholesterol",,denies,"['Chest discomfort', 'Chills', 'Cough', 'Head discomfort', 'Headache', 'Muscular weakness', 'Somnolence', 'Tachycardia']",1,PFIZER\BIONTECH,IM 926167,TX,39.0,F,"Back pain, body pain, headache, stuffy nouse. Went to do covid test and came positive",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,SEN,Yes vitamins,No,Hodgkins Disease diagnosed in 2000,,Penicillin,"['Back pain', 'Headache', 'Nasal congestion', 'Pain', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 926168,IN,54.0,M,"I woke up the morning after the vaccine with a moderate headache. Felt very tired, no energy. Later in the day it seemed as though I had COVID again. Winded very easily, no strength, body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"Amitriptylin 25 mg daily, Rosuvastatin 10mg daily, Dayquil x2, Butal/acetamn/cf 50-325-40, Motrin 200 mg 3 pills,","COVID-19 Nov 27,2020.","High cholesterol, Migraines,",,Nasonex,"['Asthenia', 'Dyspnoea', 'Fatigue', 'Headache', 'Pain']",1,PFIZER\BIONTECH,IM 926170,VT,32.0,F,"HA, body aches. Feels poorly. Did not come to work",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Feeling abnormal', 'Headache', 'Impaired work ability', 'Pain']",UNK,MODERNA, 926171,WA,61.0,F,"Woke up this morning (the day after receiving the vaccine) with chills, fever of 101.9 & diarrhea. Called my manager at work. Went back to bed. Around 8am took 2 Tylenol extra strength 225 caplets, 500mg each. 3 hours later temp down to 99.2. My normal is 97.6",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"Meloxicam, echinacia, B12, Vit D",none,Arthritis,,none that I know of,"['Chills', 'Diarrhoea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 926173,IN,41.0,F,I Initially just had a sore left arm which felt better the next day. I woke up the morning after the Vaccine (1/6/21) and experienced right jaw pain which extend it to my ear which was worse during chewing and talking. Today on January 7 it is still present however seems milder,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Vitamin,None,Overweight,,Penicillin,"['Ear pain', 'Pain', 'Pain in extremity', 'Pain in jaw']",1,PFIZER\BIONTECH,SYR 926174,FL,44.0,F,"Pain at the injection site began the day of vaccination, and remained until yesterday (1/6/2021). During this time there was no redness or swelling. On 1/6/2021 arm became dark red swollen and hot with small blisters at the vaccination site (3inx2in) and, swelling and redness has extended down to the elbow on all sides of the arm. Also 1/6, experienced joint pain and chills in mid afternoon and fever of 100F. Treated with Advil 1/6. Some mild joint pain remains 1/7. Medrol dose pack started 1/7 for the arm pain and swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,"Enalapril, Cardizem, Synthroid",none,"asthma, hypothyroid, proteinuria, hypertension",,none,"['Arthralgia', 'Chills', 'Injection site erythema', 'Injection site pain', 'Pyrexia', 'Vaccination site swelling', 'Vaccination site vesicles', 'Vaccination site warmth']",1,MODERNA,IM 926176,PA,18.0,F,Arm hurt after vaccine but developed numbness radiating from shoulder to fingers and around should to back. Arm is painful with tingling and numbness. Started 14 days after getting vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,01/03/2021,13.0,PVT,Birth Control,None noticeably present at time but was tested COVID positive on 12/26/20,None,,"Pencillin, amoxicillin sulfa drugs","['COVID-19', 'Hypoaesthesia', 'Pain in extremity', 'Paraesthesia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,IM 926177,IN,24.0,F,"fever, body aches , chills, joint pain, headache, sore soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,"multi vitamin, amoxicillin",covid 19,,,,"['Arthralgia', 'Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 926178,,69.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,['Unevaluable event'],UNK,PFIZER\BIONTECH, 926179,ID,48.0,F,"Heavy nausea, cold/clammy hands (all day), headache, body chills, fatigue, body pain, back pain, discomfort",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,None,COVID POSITIVE 12/28/2020 COVID SYMPTOMS 12/24/2020,,,None,"['Back pain', 'Cold sweat', 'Discomfort', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Peripheral coldness']",1,MODERNA,SYR 926180,IN,26.0,M,"Fever, chills, headache, brain fog",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Singulair, Insulin",No,Type 1 diabetes,,,"['Chills', 'Feeling abnormal', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 926181,ID,61.0,F,Livedo Reticularis. A red/purple pattern on the back of both legs.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/27/2020,1.0,PVT,"Humira, Cardizem, Sulindac, Aspirin 81 mg, Myrbetriq, Zolpedim, Zyrtec, Vit-D, Zinc, Calcium, multi-vitamin",,"Autoimmune disorder, immunocompromised, taking Humira injections. Also have Prinzmetal angina.",Flu vaccine (containing eggs) - allergic to eggs,"Gadolinium, sulfa, codeine, wasps & yellow jackets, eggs, cow's milk",['Livedo reticularis'],1,PFIZER\BIONTECH,IM 926182,NJ,56.0,F,"Headache, chills, hot flashes, rash on face, feeling like ""mosquito bites"" all over the body",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,PVT,"Xanax, sleep medications",,,,"Ampicillin, seafood, lactose","['Chills', 'Headache', 'Hot flush', 'Paraesthesia', 'Rash']",1,PFIZER\BIONTECH,IM 926183,NM,59.0,F,"stomach cramps, nausea, dizziness, subjective fevers, bilateral swelling cervical nodes, denies sore throat, mild headache, denies respiratory difficulties. States that with 1st vaccine had hives inside rt elbow and wrist,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,None,None,No,Hives inner aspect rt elbow and wrist with 1st dose Covid-19,None,"['Abdominal pain upper', 'Dizziness', 'Lymphadenopathy', 'Nausea', 'Pyrexia', 'Urticaria']",2,PFIZER\BIONTECH,IM 926184,OH,52.0,F,"Developed severe headache, posterior neck pain, body aches, chills fatigue fever 100.1 nausea, dry heaves started at 10 PM l/6",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,none,none,"hypothyroid, osteoporosis, COVID long hauler",,none,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Neck pain', 'Pain', 'Pyrexia', 'Retching']",1,MODERNA,IM 926185,NY,64.0,F,"I woke up on 1/6/2021 with a headache and swollen, hard, lymph nodes under my left arm (same arm as shot). No Fever, No Chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/06/2021,8.0,PUB,"Pregabalin, Sertraline, Trazadone, Omeprazole",,Fibromyalgia,,None,"['Headache', 'Induration', 'Lymphadenopathy']",1,MODERNA,IM 926186,VA,58.0,F,"Patient complained of itching and redness on neck, tingling around lips, apprehension, heart palpitations. BP 172/82, HR 128. Fifteen minutes later BP 180/90, HR 80. Patient monitored in clinic by physician, no medications administered. Discharged home ambulatory with spouse.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,,,,,,"['Anxiety', 'Erythema', 'Palpitations', 'Paraesthesia oral', 'Pruritus']",1,MODERNA,IM 926187,IL,67.0,M,"Employee was scheduled by manager to receive second dose of vaccine. Employee presented to clinic, didn't have vaccination card and received the Pfizer vaccine. Afterwards it was found that this employee's first dose was Moderna and was given on 12/29/2020. Employee did not have any adverse effects, just received second dose too soon and with the wrong manufacturer.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Incorrect dose administered', 'No adverse event']",2,PFIZER\BIONTECH,IM 926188,TX,50.0,F,"Moderna COVID-19 Vaccine EUA tingling and numbness in the mouth, tongue, & throat",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,Lisinopril 10mg Tri-Sprintec,none,high blood pressure obesity,,none,"['Hypoaesthesia oral', 'Paraesthesia oral', 'Pharyngeal hypoaesthesia', 'Pharyngeal paraesthesia']",UNK,MODERNA, 926189,OK,77.0,M,"THE NIGHT OF VACC DAY, C/O SEVERE INJ ARM PAIN. THE FOLLOWING DAY, HE BEGAN DISPLAYING VERBAL AGGRESSION AND OUTBURST TOWARDS STAFF WHICH IS OUT OF NORMAL FOR HIM, INCREASED DIFF REMEMBERING SHORT TERM, C/O DIZZINESS AND SEVERE HEADACHE RATED 10/10 ON PAIN SCALE NOT RELIEVED WITH SEVERAL DOSES OF PAIN MEDS AND RANDOM DIZZINESS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,"BUSPAR, ASPIRIN, ZYRTEC, KLONOPIN, LASIX, GABAPENTIN, KEPPRA, TOPROL XL, REMERON, MULTIVITAMIN, PRILOSEC, PAXIL, PRAVACHOL, RANEXA, FLOMAX, VITAMIN B-1, VITAMIN B-12, TYLENOL, ANTACID SUSPENSION REG STRENGTH, GUAIFENESIN SYRUP, EXCEDRIN E.S",,"GEN ANXIETY DIS, DEPRESSION, HYPERTENSION, GERD, CAD, ANGINA, CONSTIPATION, HYPERCHOLESTEROLEMIA, NEUROPATHY, MOOD DIS, BIPOLAR MANIA, INSOMNIA, ERECTILE DYS, EXTRAPYRAMIDAL REACTION, SEIZURE DIS, BPH, ALLERGIC RHINITIS, CHF",,"PENICILLINS, SULFA ANTIBIOTICS, CIPROFLOXACIN","['Aggression', 'Anger', 'Dizziness', 'Headache', 'Injection site pain', 'Memory impairment']",1,PFIZER\BIONTECH,IM 926190,WI,55.0,F,Exactly one week after shot developed pain in back left flank. Over several days it moved to left side and front. One week later a rash developed. It is diagnosed as shingles. I?m now on Valtrex . I was also working night shift for several months which also may be the cause. I submit this because I?m not stressed. I don?t get sick. Maybe my immunity was suppressed by vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/31/2020,8.0,PVT,"Levothyroxine, Vit D, Lisinopril, Amlodipine",None. No illness for years.,"High blood pressure, high cholesterol",,Sensitivity to statins- I develop pain walking and standing so I don?t take these.,"['Flank pain', 'Herpes zoster', 'Rash']",1,PFIZER\BIONTECH,SYR 926191,AK,56.0,F,"Itching, hives, hoarse throat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,"Bp meds, steroids, singular, entivyo, reflux meds","Crohn?s disease, minere?s disease",Crohn?s,Medications listed,"Banana, avocado, cipro, Remicade, Entyvio Humira, Tetanus","['Dysphonia', 'Pruritus', 'Urticaria']",1,MODERNA,SYR 926192,MD,46.0,F,Patient c/o dizziness about 5 minutes post-vaccination. Denies SOB or CP. Transported to ED by dritical care transport team where she started to c/o headache upon arrival.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,,,"CVA, migraines, anxiety, depression",,NKDA,"['Dizziness', 'Headache']",2,PFIZER\BIONTECH,IM 926193,IN,44.0,F,"Fever, headache, violent chills, body aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,None,None,High blood pressure,,None,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,SYR 926194,AL,61.0,M,dizzy,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,,,,none,['Dizziness'],2,PFIZER\BIONTECH,IM 926195,VA,23.0,F,"Itchy, red painful area with blisters near site of injection. Started 1/6/2021 and progressively has gotten worse.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/06/2021,8.0,WRK,none,none,PCOS,,none,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site vesicles']",1,MODERNA,IM 926196,,43.0,F,arm pain started same day as receiving vaccine and continues the next day but milder mild headache started the morning after receiving the vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Headache', 'Pain in extremity']",UNK,MODERNA,SYR 926197,NJ,47.0,F,"Left arm redness, swelling and pain Fever 9.99 Fon 1/5/2021 at 9 pm I took 2 Tylenol 500 mg tab 102 F on 1/6/2021 at 6:30 am I took Tylenol again around 7:30 am 2 tab of 500 mg . Fever returned around 4 pm for which I took Tylenol again and later in the evening I took total of 600 mg of Advil 200 mg . On 1/7 /2021 no fever but arm swelling and redness is much larger with induration 4-5 cm diameter Arm swelling still has not resolved as of today therefore I answered unknown to the following question.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,None,None,None,,None,"['Erythema', 'Induration', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 926198,MO,44.0,M,"Client noticed this afternoon when showering that his left armpit region was swollen approximately the size of a tennis ball and tender. Client declines any fever, redness, not warm to the touch either. Client states that he thinks it feels like enlarged lymph node",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,PUB,Lisinopril Multivitamin Loratidine Famatodine,,HTN,,NKA,"['Lymphadenopathy', 'Tenderness']",1,PFIZER\BIONTECH,IM 926199,OH,46.0,F,"12/28/20: Within 90 minutes of vaccine, heart palpitations, upset stomach, lightheaded/ woozy, pain to injection site, unable to raise arm easily, diaphoretic. 12/29/20: continued with heart palpitations off and on, lost total control of my left hand for about 10 to 15 minutes large tremors. continued with pain at injection site, unable to raise arm easily. Arm pain continued daily, occasional heart palpitations mostly within first 3 days of vaccine, continued to have weird sensation throughout my left arm w/ slight heaviness. On 1/6/21: Left armpit swelling noted with pain that increased with touch, red- raised/swollen- hot area noted to left injection site. 1/7/21: Same symptoms but swelling to left armpit slightly better, still tender, still strange left arm sensation from shoulder to fingertips- not able to use hand/ arm at 100%- have difficulty holding things and typing with left hand periodically, still has swollen reddened warm area at injection site to left deltoid.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,"Larin 24, Fish Oil, MVI",none,None,,Bactrim,"['Abdominal discomfort', 'Axillary pain', 'Dizziness', 'Hyperhidrosis', 'Injected limb mobility decreased', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Limb discomfort', 'Motor dysfunction', 'Musculoskeletal disorder', 'Oedema peripheral', 'Pain in extremity', 'Palpitations', 'Sensory disturbance', 'Tenderness', 'Tremor']",1,MODERNA,IM 926200,NC,24.0,F,"Within 25-30 minutes, patient began having ""itching in her throat"" and tachycardia on assessment",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,,,,,contrast dye,"['Tachycardia', 'Throat irritation']",1,PFIZER\BIONTECH,SYR 926201,OH,34.0,M,"Chills, myalgias, moderately severe fatigue, mild nausea, dizziness/orthostatic dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/06/2021,5.0,PVT,None,None,None,,None,"['Chills', 'Dizziness', 'Dizziness postural', 'Fatigue', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,IM 926202,GA,43.0,F,"metallic taste, numbess tonque and left arm, no treatemnt at present",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,none,none,none,,pcn,"['Dysgeusia', 'Hypoaesthesia', 'Hypoaesthesia oral']",2,PFIZER\BIONTECH,IM 926203,OH,48.0,F,"She reported pain and swelling on left deltoid, rash present measured 8 X 6.5cm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,PVT,"Multivitamin 45+, Biotin supplement, Motrin 400mg, Tylenol 650mg",none,none,,penicillin,"['Injection site pain', 'Injection site rash', 'Injection site swelling']",1,MODERNA,IM 926204,AZ,74.0,M,Mild dizziness immediately after vaccination was administered. Lasted approx 5 minutes and self resolved. Normal neuro examination per provider.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Aspirin, Amlodipine, Cholecalciferol, Atorvastatin, Lisinopril",None,"Type II DM, HTN",,Penicillin,"['Dizziness', 'Immediate post-injection reaction']",1,PFIZER\BIONTECH,IM 926205,TX,55.0,F,First dose of vaccine administered on 1/6/2021 at 1:33pm. Headache and fever started 1/7/2021 around noon. Reports taking Tylenol to help alleviate symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,,,,,,"['Headache', 'Pyrexia']",1,PFIZER\BIONTECH,IM 926206,CA,48.0,M,at about 1730 pm on 12/30/2020 patient experienced chills. He took 1 Tylenol tab 500 mg. He went to bed and in the am the Chills had subsided.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,"timolol, travitan, rhoppresa- eye drops for gylcoma",none,None,,dairy products,['Chills'],UNK,MODERNA,IM 926207,IN,23.0,M,"Early on in the day of 1/6/21, I felt very sluggish and spaced. My boss asked me early in the day if I was okay because she said that I seemed ""out of it."" It wasn't to the point that I was unable to work, but it was a noticeable difference from my typical state. At 11:31 AM, I texted my wife and said ""I feel gross and weird today."" When she asked me how so, I replied, ""I just feel run down, my neck hurts, and I can't focus."" My arm was more sore than it typically is from the flu shot, but it wasn't unbearable. As the day went on, I felt the cloudiness in my head start to dissipate a bit and I started to feel a little better. By dinnertime, I was feeling sick to my stomach and was not able to eat very much. I chose to head to bed around 9 because I was feeling pretty ill (my neck had really started feeling sore again and my stomach was very upset.) At 1:30 AM on 1/8/21, I woke up with a horrible headache. I get migraines from time to time, but this was unlike anything I had ever felt before. It felt like my head was in a vise and I was very close to asking my wife to take me to the ER. I never go to the doctor, but it legitimately scared me. My neck was extremely sore and my head hurt so bad that even laying it on a pillow hurt. I was extremely nauseous as well. I took a few extra strength Tylenol and laid my neck on a heating pad with an ice back on my forehead. The sound of our humidifier was too much for me, so I also out in earplugs. After an hour or so, I fell back asleep. When I woke up this morning, I still had a headache and I took an Excedrin. To this point, I have felt a little sick to my stomach, but the intense headache has been kept at bay. My neck is still sore but it is also somewhat better.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,,,,,None that I know of.,"['Abdominal discomfort', 'Disturbance in attention', 'Fatigue', 'Fear', 'Feeding disorder', 'Feeling abnormal', 'Headache', 'Hyperacusis', 'Injection site pain', 'Malaise', 'Nausea', 'Neck pain', 'Pain', 'Sluggishness', 'Tension headache']",1,MODERNA,IM 926208,IN,47.0,F,"pain at injection site as well and shoulder (posterior/anterior), radiating down arm",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Injection site pain', 'Pain', 'Pain in extremity']",1,MODERNA,IM 926209,NY,62.0,F,"about an hour after injection, i noticed a bitter taste in the back of my throat and upper back toward tonsils and is still there for now. i am fine.. i just wanted you to. know it has that side effect. i plan to get the second part of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,"heart meds: cozaar, digoxin, metoprolol ex, kdur, losartan potassim, klonopine, lexapro",no,dilated cardiomyopathy,the original shingles vaccine by merck live vaccine. made my arm swell and created a sunburn on my right arm and i had to get a,adenosine injection,['Dysgeusia'],UNK,MODERNA,IM 926210,PR,50.0,F,"general malaise, joint pain (hands, elbows, knees, ankles)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,none,none,none,,cephalosporin,"['Arthralgia', 'Malaise']",1,MODERNA,IM 926211,PA,32.0,F,Angioedema of the lips began about 14 hours after vaccine administration. Progressed to full facial swelling by 18 hours without respiratory compromise. Developed body urticaria. Resolved with time and oral prednisone.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,No,No,No,,No,"['Angioedema', 'Swelling face', 'Urticaria']",2,PFIZER\BIONTECH,IM 926212,CO,30.0,F,"One week later woke up to swelling around injection site, feels like a bee sting. Hard, itchy, warm and lymph nodes on that side are painful and very sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/07/2021,7.0,PVT,no,none,none,,no; allergic to hornets,"['Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Lymph node pain']",1,MODERNA,IM 926213,MI,89.0,F,Redness at injection site (R) Deltoid,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/05/2021,3.0,UNK,,,,,,['Injection site erythema'],UNK,MODERNA,IM 926214,AR,43.0,F,"14 hrs after vaccination developed fever 101.4, headache, myalgia and chills. decreased the next day but head ache and low grade fever remain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Synthroid , zitalopram, multi-vits",none,hypothyroidism,,None,"['Chills', 'Headache', 'Myalgia', 'Oral herpes']",2,PFIZER\BIONTECH,IM 926217,WI,27.0,F,"I received the vaccine at 2pm on January 5, 2021. At 8pm I started to feel tightness in my chest. Then it kept getting worse, and developed a burning feeling when I breathe. It has been intense since then.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,SEN,Buproprion 100 mg Tylenol Ibuprofen Miralax,,Fibromyalgia Chronic Fatigue,,Sertraline Peroxatine Lexapro,"['Chest discomfort', 'Chest pain', 'Painful respiration']",1,MODERNA,IM 926218,OR,47.0,M,Numbness noted in tongue and back of mouth/throat starting morning after injection. No other associated symptoms noted,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,SEN,,,,,,"['Hypoaesthesia oral', 'Pharyngeal hypoaesthesia']",1,PFIZER\BIONTECH,IM 926219,TX,39.0,F,"Rubella type rash on my body. Itching and burning going on 8 days now and nobody can figure it out. Steroids, Benadryl aterax no change",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,,,,,Mango,"['Burning sensation', 'Laboratory test normal', 'Pruritus', 'Rash', 'Rubella']",1,MODERNA,IM 926220,WA,52.0,M,"Patient is a 52 y.o. male. Chief Complaint Patient presents with ? Allergic reaction � � Reaction to Covid Vaccine � � � Is patient concerned about a specific cause for the current symptoms? Yes Covid Vaccine Onset of symptoms: 0830. Symptoms include: difficulty breathing and/or wheezing, rapid heart rate or palpitations and generalized redness. Rash distribution: Face. How are symptoms changing over time? improving. � Patient describes symptoms as moderate. Has patient tried any treatment for these symptoms?No What makes the symptoms better? Rest and time What makes the symptoms worse? Nothing � Patient states that the shortness of breath and the increased heart rate started after about 4 minutes - then went away but came back much stronger at 10 minutes post vaccination � No itching, wheezing, cough - just flushed and chilled Increased HR and jittery � Did have surgery recently � Did have Moh's procedure in the fall and had a reaction to the lidocaine - increased heart rate, increased blood pressure � Associated symptoms: � o Fever No � o Sore throat No � o Recent illness No � o Exposure to person(s) with similar rash No � Patient has flu vaccine documented this season. �Patient Active Problem List Diagnosis ? Migraine ? Obstructive sleep apnea syndrome ? Calculus of gallbladder without cholecystitis without obstruction ? Hemiplegic migraine without status migrainosus, not intractable ? Low HDL (under 40) ? History of nonmelanoma skin cancer ? Encounter for screening colonoscopy ? Essential tremor � Medical History Past Medical History: Diagnosis Date ? Acquired hypothyroidism � ? Chronic kidney disease � � Stage 2 ? Chronic migraine with aura 01/04/2013 ? Colon polyps � ? Color blind � ? Enlarged prostate � ? GERD (gastroesophageal reflux disease) � ? Hemiplegic migraine � ? Hx of febrile seizure � ? Kidney stones � � x 1 - 2001 ? Nodular basal cell carcinoma (BCC) 09/08/2020 � bcc nod, rt cheeck and rt medial cheek ? Obstructive sleep apnea syndrome 11/04/2013 � Home sleep testing on 10/31/13 with apnea/hypopnea index = 9 and low oxygen saturation = 90%. Auto-PAP titration pending. Surgical History Past Surgical History: Procedure Laterality Date ? Colonoscopy � 04/10/2020 � ksc ? Hx lap cholecystectomy N/A 12/23/2020 � LAPAROSCOPIC CHOLECYSTECTOMY ? Hx of mohs/skin cancer surgery and repair � 09/08/2020 � bcc nod, rt cheek ? Hx of mohs/skin cancer surgery and repair � 09/08/2020 � bcc nod, rt medial cheek ? Hx wisdom teeth extraction � � ? Upper gi endoscopy � 04/10/2020 � ksc Objective: BP 116/74 | Pulse 84 | Temp 97.9 �F (36.6 �C) (Oral) | Resp 18 | SpO2 97% General:well-hydrated, well nourished, no acute distress HEENT: ENT exam normal, no neck nodes or sinus tenderness Lung: clear to auscultation bilaterally Heart: regular rhythm, tachycardia noted and no murmurs, clicks, or gallops. Extremities: extremities normal, atraumatic, no cyanosis or edema Skin: flushed (face and neck and chest primarily) , no hives Neuro: alert, orientation normal, speech normal � 9:30 AM Improving symptoms Decreased HR, although patient states if feels like it is cycling, flushing is almost resolved No hives or shortness of breath Mild jittery feeling �",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,Magnesium 250 MG tablet Take by mouth 2 times daily. � � ? Cholecalciferol (VITAMIN D3 PO) Take by mouth. � � ? Verapamil HCl ER (Verelan SR) 240 MG capsule (24 hour) Take 1 capsule by mouth every day. 90 Cap 3 ? Tamsulosin HCl 0.4 MG cap,hx of Migraines had a laparoscopic Cholecystectomy on 12/23/2020,"RIGHT handed 52 y.o. male with a past medical history consistent with objective sleep apnea on CPAP, renal stone (2001), BPH, chronic migraine with aura and hemiplegic migraine . hx of Basal Cell Carcinoma of the skin in the past.",,"Sulfa Antibiotics Rash, Nausea and Vomiting Triptans [Sumatriptan]Adverse Drug Reaction","['Chills', 'Dyspnoea', 'Electrocardiogram normal', 'Erythema', 'Feeling jittery', 'Flushing', 'Heart rate increased', 'Palpitations', 'Rash', 'Tachycardia', 'Wheezing']",1,MODERNA,IM 926221,OH,64.0,F,"Patient contacted provider 12/26 with following symptoms: Dry cough, diarrhea, fatigue for 7 days. Covid test ordered and positive. presented to ED on 12/31 and admitted into hospital. Still inpatient as of 1/7/2021.",Not Reported,,Not Reported,Yes,8.0,Not Reported,N,12/18/2020,12/19/2020,1.0,PVT,"Levothyroxine 50mcg daily , Aloglitpan Benzoate 25mg daily, alendronate 70mg once weekly.",11/20/20 appointment for mid-thoracic back pain.,"Essential Hypertension, Hyperlipidemia, Hypothyroid, Type 2 diabetes with renal complication, without insulin , Chronic renal disease., BMI 36.58",,NKA,"['Blood immunoglobulin G', 'Cough', 'Diarrhoea', 'Fatigue', 'Full blood count', 'Liver function test', 'Metabolic function test', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 test positive', 'T-lymphocyte count']",1,PFIZER\BIONTECH,IM 926222,WI,34.0,M,"left upper arm muscle pain, left shoulder pain, some discomfort in left forearm and left elbow, decreased ROM left arm and left shoulder",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,,,,,,"['Arthralgia', 'Joint range of motion decreased', 'Limb discomfort', 'Myalgia']",1,PFIZER\BIONTECH,IM 926223,NJ,34.0,F,Felt a faint pain behind my left breast around 30 minutes after receiving the vaccination. I also got the vaccine on my left arm. The dull or faint pain is not constant and I will randomly feel it since receiving the vaccine. This is some thing that I have experience in the past when I have had too much caffeine but in the past it was more prominent whereas right now it?s very light and faint and dull,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,None,None,None,,None,['Breast pain'],UNK,PFIZER\BIONTECH, 926224,NV,31.0,F,"Injection site just became swollen, red, warm, and itchy. It looks like a big bite and with redness is about 5cm in diameter. I have taken loratodine but it hasn?t helped.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,WRK,N/a,None,Anemia,,NKDA,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 926225,IN,59.0,F,"When driving home my throat started to feel like it was closing. I drank cold water the entire way home. I kept debating on turning around but was able to drink water. This started 15 minutes into my drive home, 30 minutes after shot. Once home I ate dinner and drank more water. This feeling last a couple hours. Am concerned about booster.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Daily vitamin. Lexapro 10mg. Fish Oil,None,None,,None,['Throat tightness'],1,PFIZER\BIONTECH, 926226,OH,48.0,M,"Incident occurred at a COVID19 mass vaccination clinic. Within 5-10 minutes after vaccination, client complaint of dizziness, nausea, and right eye was twitching and drooping. Client stated that they had a history of penicillin allergy with a hives/rash reaction. Client checked his sugar and it was at 138. EMS that was on-site checked vitals @11:22 BP 160/100 pulse 72 resp 16 pupils NTL , alert and verbal, skin normal, respirations normal; @11:33 BP 160/105. Client initially refusing transport by EMS. After 45 minutes of blood pressure not dropping, client agreed. @11:50 EMS transport by EMS. Hospital has attempted to reach client for follow up of outcome but has not received return call.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PUB,"stated he took an antihistamine, otherwise unknown",stated cleared from positive COVID19 isolation 3 weeks prior,"HTN, diabetes type II",,stated penicillin- hives,"['Blepharospasm', 'Blood glucose normal', 'Blood pressure increased', 'Dizziness', 'Eyelid function disorder', 'Nausea']",1,MODERNA,IM 926227,VT,45.0,F,"Fever and body aches, feels poorly. Stayed home from work",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Feeling abnormal', 'Impaired work ability', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 926228,MN,41.0,F,"fatigue - onset about 1230, I usually don't take naps but I took a 4 hour nap that day headache - onset about 1230, lasted the rest of the day and intermittently the next few days injection site pain x 3 days - moderate, pain would wake me in my sleep if I rolled onto affected side",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,"Zoloft, Wellbutrin, Topamax, Zyrtec",none,anxiety (controlled) headaches (controlled) allergic rhinitis,,none,"['Condition aggravated', 'Fatigue', 'Headache', 'Injection site pain', 'Sleep disorder', 'Somnolence']",1,PFIZER\BIONTECH,IM 926229,AL,48.0,M,"Fatigue that requires daily naps and 12-14 hours of sleep daily. Shortness of breath, despite normal saturation 97% on room air. Dyspnea with exertion with normal sinus rhythm rate in 80s. Cheat tightness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/19/2020,1.0,PVT,Aspirin 325 mg daily Bystolic 5mg daily Nexium daily Centrum MVI D3 daily,"Covid positive with one week hospitalization July 3, 2020. Required oxygen by Nasal cannula. Received Remdisivir which caused liver enzyme elevations. EF decreased to 40% from 50% from Covid. Received convalescent plasma, melatonin, Pepcid, decadron 6mg x 10 days. Had steroid withdrawal due to lack of tapering. Bystolic 5 mg started to keep HR below 100.",Mild hypertension and gerd,,Sulfa-hypotension Percocet-itching,"['Chest discomfort', 'Dyspnoea', 'Fatigue', 'Hypersomnia', 'Oxygen saturation normal']",1,PFIZER\BIONTECH,SYR 926230,PA,40.0,F,Patient experienced an episode of SVT and then sinus tachycardia for approximately 6 hours after injection,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Symbicort Levothyroxine Myrbetriq vitamin D vitamin C Calcium,,Asthma Hashimotos Thyroiditis Overactive bladder,,Penicillin Clindamycin,"['Echocardiogram', 'Electrocardiogram', 'Full blood count', 'Laboratory test', 'Sinus tachycardia', 'Supraventricular tachycardia']",1,MODERNA,IM 926231,PA,41.0,M,"injection site pain, triedness, headache, muscles pain, chills, fever, joints pain feeling unwell, weakness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,no,Flu two weeks before,none,,no,"['Arthralgia', 'Asthenia', 'Chills', 'Fatigue', 'Headache', 'Influenza virus test negative', 'Injection site pain', 'Malaise', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH,IM 926232,AL,42.0,F,"chills, cold sweats, diarrhea, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"multi vitamin, collagen, chondroitin, zyrtec, advil (3 hours & 7 hours after vaccine)",none,none,,none,"['Chills', 'Cold sweat', 'Diarrhoea', 'Myalgia']",2,PFIZER\BIONTECH,SYR 926233,TX,42.0,F,"Moderna COVID-19 Vaccine EUA: Persistent swelling, redness, inflammation and soreness at injection site 8+ days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,"Multivitamin, Progesterone (100 mg/day)",none,Lymphangioleiomyomatosis,,"Latex, bell peppers, vitamin E (Atopic dermatitis)","['Injection site erythema', 'Injection site inflammation', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 926234,MI,82.0,F,"Weakness, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/05/2021,3.0,SEN,,,,,,"['Asthenia', 'Pain']",UNK,MODERNA,IM 926235,FL,69.0,F,"Migraine headache, Heart palpitations, Site redness and edematous with pruritus lasting longer than a week and size of a silver dollar",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Vit B12, Zinc, Magnesium. Garlic, Amitriptyline, Motrin, Excedrin Migraine, Norvasc",None,"High Blood Pressure, Migraines",,"Cortisone, Alcohol, Erythromycin","['Injection site erythema', 'Injection site oedema', 'Injection site pruritus', 'Migraine', 'Palpitations']",1,MODERNA,IM 926236,NY,64.0,F,Patient received injection at 1130 and immediately was dizzy. She then waited her 15 minutes and felt fine and went back to work (in the same building). She ate lunch and then blurry vision started around 1400. She then came back down and was evaluated by a nurse. She was asked to sit and be monitored and at 1420 she reports distantly blurry vision. Vital signs were within normal limits and patient concurrs normal for her.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,"mexotrexate, prozac, propranolol, folic acid, atorvastatin, calcium with d, osteo biflex, vitamin b complex, fish oil,",none,"high cholesterol, anxiety, depression, psoriatic arthritis",,,"['Dizziness', 'Vision blurred']",1,MODERNA,IM 926237,IA,56.0,F,arm soreness from 12/31/20 to 1/5/21. fatigue 12/31/20 to 1/4/21.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,WRK,,,"asthma, hypertension, hypothyroidism.","warmth, redness, swelling, itchiness at injection site with flu shot.",,"['Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 926238,NM,59.0,F,"Moderna COVID -19 Vaccine EUA: Day 1, sore arm (expected) up to Day 5; Days 2 to today: extreme tiredness like mono, and vertigo upon turning head, lifting head from pillow or putting head down on pillow to go to sleep. I cannot turn suddenly, pick items up from the floor, or rotate without having vertigo. It is especially extreme when lying down to go to sleep or getting up in the morning. Days 3-5 Body aches as if I was getting the flu. I no longer have a sore arm or body aches, but the vertigo has not changed. I went to hospital 1/4/21 about the problem with vertigo and they told me to see my personal doctor if I still have the problem on 1/11/21. They gave me Meclizine 25 mg 2 capsules every 8 hours, however I am working and the label says not to use when driving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,"Metformin, 1,000 mg 2X a day with food; Fenofibrate, 48 mg, 1X a day with food; Lisinopril, 20 mg, 1X a day; Simvastatin, 80 mg, 1X a day at bedtime; Pantoprazole Sodium, delayed-release 40 mg as needed. Supplements and vitamins: B12 5,000",None known.,Type II Diabetes; Very high Cholesterol; just started on high blood pressure medicine in November.,,Amoxicillin; Penicillin; Sulfa; Hydrocodone; Juniper (severe).,"['Fatigue', 'Infectious mononucleosis', 'Influenza like illness', 'Pain', 'Pain in extremity', 'Vertigo positional']",1,MODERNA,IM 926239,GA,37.0,F,"Pfizer BioNTech COVID-19 Vaccine EUA; when patient was in 15 minute observation she reported feely dizzy and getting ""tunnel vision."" Patient sat down on the floor of her own accord without injury or difficulty. Had patient elevate her legs above heart level. Checked patients vitals, her blood pressure was low, but O2, respiration and pulse were within normal range. Patient was shaking and reported her tongue felt ""tingly"" and ""heavy on my chest."" Patient reported she had a smoothie prior to coming in for her appointment. She was given sprite. Patient felt better, but approximately 7 minutes later reported her stomach felt queezy. Blood pressure had improved and other vitals were still stable. Patient still reported her tongue felt ""tingly,"" but no swelling, trouble breathing, or throat tightness. Patient was picked up by her father 45 minutes later and was able to ambulate to the car (with supervision) of her own accord without assistance.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,,,,,Acetaminophen Codeine Shellfish,"['Abdominal discomfort', 'Blood pressure decreased', 'Chest discomfort', 'Dizziness', 'Paraesthesia oral', 'Tremor', 'Tunnel vision']",1,PFIZER\BIONTECH,IM 926240,MA,35.0,F,"All mild symptoms in list except stomach issues. Fever, joint and muscle pains, headache, exhaustion, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,UNK,Lamectil Synthroid May have skipped doses,No,Epilepsy Asthma Hypothyroid,,Percocet,"['Abdominal discomfort', 'Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 926241,OH,40.0,M,"WARM, REDDENED AREA ON ARM OF INJECTION. THE REDDENED AREA MEASURES ABOUT 4X5 INCHES AND IS LOCATED APPROXIMATELY 2 INCHES BELOW THE VACCINATION INJECTION SITE. THE AREA BECAME RED AND WARM 9 DAYS AFTER VACCINATION. PREVIOUS TO THIS REACTION, I ONLY EXPERIENCED PAIN IN THE ARM OF INJECTION ON DAYS 2-3 POST VACCINATION.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/06/2021,9.0,PVT,DAILY VITAMINS; AIRBORNE,NO,,,PENICILLIN,"['Injection site erythema', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 926242,IL,62.0,F,"I had the 1st Pfiser Covid Vaccine on 12/21/20 and on 12/24/20 I had abdominal pains resulting in diarrhea turning into bright red bleeding by the late morning on 12/25/20. I continued to bleed for hours (only when cramping) and ended up going to an ED for severe abdominal pain, bleeding, nausea and general weakness. The ED doctor said it was from internal hemorrhoids and the diarrhea and was not sure it was related to the Covid Vaccine and possible being an intestinal flu but I felt like I needed to report. I also had nausea and vomiting the evening of 12/26/20 lasting about 12 hours. It took me a few days of Zofran and Imodium to get it in control and the bleeding did stop by 12/27/20.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/24/2020,3.0,PVT,Lipitor 20mg qd Losartan/Hydrochlorathiazide 50mg/12.5mg qd Asa 81 mg qd Zinc 25 mg qd D3 1000IU qd,None,Minor Hypertension Elevated CHOL,,None,"['Abdominal pain', 'Asthenia', 'Diarrhoea', 'Full blood count', 'Haemorrhoids', 'Laboratory test', 'Muscle spasms', 'Nausea', 'Rectal haemorrhage', 'Vomiting']",1,PFIZER\BIONTECH,IM 926243,KY,38.0,F,"Two days after receiving vaccine employee began to experience a discomfort in right chest wall upon inspiration. Upon physical assessment there was not redness, swelling or limited mobility of extremity, no noted lymph node inflammation detected. Thus far discomfort has caused no loss of sleep or other activity.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,OTH,None,None,,,None,['Chest discomfort'],1,MODERNA,IM 926244,,30.0,F,Day 6 - developed rash/hives and swollen area over injection site. Then developed hives on face. Hives on face disappeared after 4 hours. Rash/hives/swollen arm is still present 24 hours later.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/06/2021,6.0,WRK,Kelnor 1/35 - birth control,Sinus infection,Ulcerative colitis,,Mushrooms,"['Injection site rash', 'Injection site swelling', 'Injection site urticaria', 'Urticaria']",1,MODERNA, 926245,IL,58.0,M,"01/06/2021 2nd dose: Sore arm, metallic taste in mouth mild nausea tired feeling 12/17/2020 1st dose Pfizer vaccine :Sore arm, metallic taste in mouth mild nausea tired feeling and headache .",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,"Rosuvastatin, Crestor, Zetia, Plavix , baby aspirin vitamin D, Latanoprost eye drop, aleve",,Glaucoma coronary heart disease asthma diverculitis,,,"['Dysgeusia', 'Fatigue', 'Headache', 'Nausea', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 926246,MI,89.0,F,Redness at injection site (R) Deltoid,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/05/2021,3.0,SEN,,,,,,['Injection site erythema'],UNK,MODERNA,IM 926247,KY,64.0,F,"I was feeling fatigue night after injection. Next morning I passed out, woke up sweaty. Then started vomiting and having severe leg cramps. Called employee health and they said to go to emergency department.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,WRK,"Norvasc 5mg, lisinopril 40mg, pravastatin 20mg, Synthroid 112mcg, potassium 99mg, biotin 10,000mg, glucosamine 1500mg, chondroitin 1200mg, fish oil 1200mg, flaxseed oil 1300mg, probiotic",none,"hypertension, hypothyroidism, high cholesterol",,"sulfur medications, wheat products, shell fish","['Activated partial thromboplastin time', 'Antibody test', 'Blood thyroid stimulating hormone', 'Computerised tomogram head', 'Fatigue', 'Full blood count', 'Hyperhidrosis', 'International normalised ratio', 'Loss of consciousness', 'Metabolic function test', 'Muscle spasms', 'N-terminal prohormone brain natriuretic peptide', 'Troponin', 'Urine analysis', 'Vomiting']",1,MODERNA,IM 926248,MD,43.0,F,"Known allergic reactions-requesting vaccine. Had personal EpiPen with her. Itchy throat, watering eyes.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Lacrimation increased', 'Throat irritation']",1,MODERNA,IM 926249,TX,68.0,M,Chills lasting 20 minutes starting 3 hours after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Benicar Lovistatin Metformin,None,Type 2 diabetes High blood pressure,Rash from shingles vaccine,None,['Chills'],UNK,MODERNA, 926251,FL,47.0,F,"12/28-12/29: arm/injection site soreness, then subside; 1/3-1/4-itchiness, increased pain/tenderness at injection site; 1/5-injection site tender/red/sore/swelling with increased area (used IB profen/topical cortisone); 1/6-same as 1/5 but milder and less redness; 1/7-mild tenderness with most other symptoms resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/03/2021,6.0,WRK,women's daily multivitamin,None,lower back arthritis,,NKA,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Pain in extremity']",1,MODERNA,SYR 926252,VA,34.0,F,"numbness of throat and back half of tongue, ear pressure, chest pain, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,multivitamin,none,none,,mushrooms,"['Blood pressure increased', 'Chest pain', 'Ear discomfort', 'Electrocardiogram normal', 'Hypoaesthesia oral', 'Nausea', 'Pharyngeal hypoaesthesia']",UNK,MODERNA,IM 926253,NY,62.0,F,"Very sore arm, unable to lift or move, stiff neck",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,"Hyzaar, Fexofenedine, Black Cohosh, Multivitamin, Calcium",none,none,,"Sulfa, Penicillin, mango, latex, pineapple, scents of roses, scents of pine cones, scents of lilies","['Joint range of motion decreased', 'Movement disorder', 'Musculoskeletal stiffness', 'Pain in extremity']",UNK,PFIZER\BIONTECH,SYR 926254,,62.0,M,Shortness of breath and chills after vaccine administration,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PUB,,,,,,"['Chills', 'Dyspnoea']",1,MODERNA,IM 926255,,41.0,F,"Received the Moderna vaccination on 12/28/20 (1st dose). Developed induration, redness & itching at injection site after vaccine. Still present on day 7.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus']",1,MODERNA,IM 926256,MN,60.0,F,"redness below injection site. Ice pack applied to 10 minutes. Then a large blister appeared, and a cluster of small blisters.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,,none,"MS, anemia, depression, DM",,,"['Injection site erythema', 'Injection site vesicles']",1,MODERNA,IM 926258,WI,41.0,F,PARATHESIA OF LOWER LIP,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,['Paraesthesia oral'],1,PFIZER\BIONTECH,IM 926259,VT,49.0,F,Fever and body aches. Stayed Home,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 926260,TX,33.0,F,"Moderna Covid-19 Vaccine EUA Redness and swelling in left arm, itching at injection site. Kept track by outlining and it went from 5 cm on day 2 to 9 cm on day 3. Diagnosed with cellulitis at injection site as well. Treatment of steroid shot, antibiotics, ice and Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PUB,Gabapentin Nortryptoline Zinc D3 B complex Ibuprofen Tylenol,Lupus Covid (diagnosed on 11/08/2020),Lupus,Age 21- flu vaccine- same reaction Age 23- meningitis vaccine- same reaction,Codeine Flu shot Meningitis shot Doxycycline Beef Seasonal allergies,"['Erythema', 'Injection site cellulitis', 'Injection site pruritus', 'Peripheral swelling']",1,MODERNA,SYR 926261,NJ,31.0,F,"On 1/4 2021, 7 days post injection she devloped a 4x6 mildly pruritic erythematous rash at the vaccination site. It is slowly fading",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,NONE,NONE,NONE,,NONE,"['Injection site rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 926263,TX,40.0,F,EE reports facial swelling with pressure and HA at 3:00 pm went to the ER at 6:00 pm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Discomfort', 'Headache', 'Swelling face']",2,PFIZER\BIONTECH,IM 926264,ND,32.0,F,"Developed abdominal pain, nausea, vomiting, fever and cough within 12 hours of receiving COVID 19 vaccine. Had COVID 19 in November of 2020. Severe enough symptoms to go to the ED. Received IV fluid, and zofran. Admitted to observation status and received IV pain medication for headache, enema, due to obstipation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,Neurontin 300 mg; ceterizine 10 mg; citalopram 20 mg; mirvaso 0.33% topical; ibuprofen 600 mg; tylenol 1000 mg;,,"anxiety, depression, recurrent pyelonephritis; rosacea; TBI",,Reglan,"['Abdominal pain', 'Blood alkaline phosphatase normal', 'Blood glucose normal', 'Blood lactic acid decreased', 'Blood sodium normal', 'Constipation', 'Cough', 'Enema administration', 'Headache', 'Nausea', 'Protein total decreased', 'Pyrexia', 'Red blood cell count decreased', 'Vomiting']",1,MODERNA, 926265,MD,22.0,F,My tonsils have swollen. Negative strept and covid test. Never had swollen tonsils before. No swollen glands associated,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,UNK,Enskyce,,Asthma,,,"['SARS-CoV-2 test negative', 'Streptococcus test negative', 'Tonsillar hypertrophy']",1,MODERNA,IM 926267,CO,55.0,F,Large knot on my arm where injection was given. Also spot is also red. It has gotten larger and redder since it started 2 days ago.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,None.,none,none,,Erythromycin,"['Injection site erythema', 'Injection site nodule']",1,MODERNA,SYR 926268,OH,27.0,F,Severe endometriosis flare up on right ovary. Lasted several hours pain radiated down right thigh.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,"Orilissa, Mirena",None,Endometriosis,,None,"['Condition aggravated', 'Endometriosis', 'Pain', 'Pain in extremity']",1,MODERNA,SYR 926269,MD,74.0,M,"Pt last seen at 1200 by nurse for ID band check. No visible signs of distress noted. Pt states ""I just want to be left alone"". 1230 nurse was called to pt room. Pt was noted unresponsive, no pulse and respiration noted. CPR started immediately, at 1239 first shock given. 1245 EMT took over, at 1319 EMT called time of death",Yes,01/05/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,SEN,"Acetaminophen Tablet 325 MG, Enulose Solution 10 GM/15ML (Lactulose Encephalopathy), HYDROcodone-Acetaminophen Tablet 5-325 MG, Milk of Magnesia Suspension 400 MG/5ML (Magnesium Hydroxide, Potassium Chloride ER Tablet Extended Release 20 ME","Fracture of right superior and inferior pubic rami, fracture of the right sacral alla, and fracture of the L3 vertebral body. UNSPECIFIED PROTEIN-CALORIE MALNUTRITION","Abdominal aortic aneurysm CHRONIC OBSTRUCTIVE PULMONARY DISEASE tobacco abuse, EtOH abuse Ambulatory dysfunction, debility, high risk for falls, deconditioning, ambulatory dysfunction/debility/deconditioning/high fall risk/generalized weakness MAJOR DEPRESSIVE DISORDER, RECURRENT, UNSPECIFIED PERSONAL HISTORY OF MALARIA",,No Known Allergies,"['Cardioversion', 'Death', 'Pulse absent', 'Respiratory arrest', 'Resuscitation', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 926270,ME,45.0,F,Immediately after receiving the dose employee didn't feel well. She was monitored (in her vaccination seat) with a pulse oximeter and heart rate which read 70% and 30 BPM. The vaccination clinic employees administered 1dose of epi and called a rapid response. The rapid response team arrived within 2 minutes and she was brought to the ED,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,['Malaise'],2,PFIZER\BIONTECH,IM 926271,CA,28.0,F,sluggish headache threw up sore arm fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,UNK,,,,,,"['Fatigue', 'Headache', 'Pain in extremity', 'Sluggishness', 'Vomiting']",1,MODERNA,SYR 926272,OH,45.0,F,"Headache within hour of receiving vaccine, patient took Tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,N/a,N/a,N/a,,Yes,['Headache'],1,PFIZER\BIONTECH,IM 926273,OK,40.0,F,"After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flashes and nausea, pain in left hip. Got really sleepy. Had problems with left hip, problem getting out of car very stiff. Couldn't stand on the left leg. Had stinging with every step. Burning sensation in the hip. Right arm started having nagging pain with tingling, took Tylenol. Tried to get out of bed, left hip felt like something was poking with fire. Saw bumps on hip, left back. Upper arm was still having tinge. Took Benadryl. Next morning woke up with lesions on left hip, some ruptured that felt like acid and then form a scab. The right arm started with the lesions. Went to urgent care. Dr. diagnosed patient with shingles. Patient questions the Shingles at her age. Pt was given Valtrex for the shingles.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PUB,"Lisinopril, Norvasc, Neurontin, Tylenol",flu in December. Took Tamiflu.,"high bp, Spinal surgery4 years ago, chronic migranes.",,"penicillin, iv contrast dye","['Arthralgia', 'Burning sensation', 'Dysstasia', 'Headache', 'Herpes zoster', 'Hot flush', 'Joint stiffness', 'Joint swelling', 'Nausea', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Scab', 'Skin lesion', 'Somnolence', 'Swelling']",1,PFIZER\BIONTECH,SYR 926274,FL,29.0,F,"Fever, chills, sweats, poor appetite Just a note: I was previously diagnosed with Covid in June 2020 wondering if that is a factor in having side effects",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,Birth control,,,,Sulfa,"['Chills', 'Decreased appetite', 'Hyperhidrosis', 'Pyrexia']",1,MODERNA,SYR 926275,VT,40.0,F,Body aches. Stayed home from work,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Impaired work ability', 'Pain']",UNK,PFIZER\BIONTECH, 926277,MA,60.0,F,"sore arm for 48 hours after vaccine however the 1:30 AM 12/27, spiked a fever to 101.7 oral with generalized aches, pains and GI of diarrhea, loss of appetite. fever persisted for 48 more hours reduced fever by taking 220 mg naproxen every 12 hours. Had COVID nasal swab 12/27 and again on 12/30 BOTH NEGATIVE. No real respiratory symptoms. No contacts at home with COVID. Was not working since 12/23, wears surgical mask or N95 with all patient interactions ( patient is an allergist immunologist with medical group)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/27/2020,4.0,PVT,"Pepcid 20 mg daily, flax seed, chondroitin sulfate, soluble fiber 2 tablets, Losartan 50 mg nightly Amlodipine 5 mg nightly, Divigel 1 mg/ml ,",none,Hypertension and GERD,tetanus Pertussis Diphtheria 14 years ago Arthus reaction,none,"['Decreased appetite', 'Diarrhoea', 'Pain', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 926278,CA,35.0,F,Arm feeling hot and swollen and a low grade fever. Patient reports taking Tylenol and feeling better afterward,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,WRK,"Multivitamins, Sertraine and Claritin as needed",,,,,"['Peripheral swelling', 'Pyrexia', 'Skin warm']",UNK,MODERNA, 926279,NJ,39.0,F,Hives and Itchiness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Tylenol, Benadryl, & Zrytec",,,,Latex,"['Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,IM 926280,NJ,34.0,F,"Approximately 4 hours after vaccine administration, I developed hives on my right arm. Afterward my eyes began to itch. The inner corners of both eyes swelled, along with upper and lower eyelids.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Vyvanse Toprol XL,,Baseline Tachycardia ADHD,,Sulfa medications,"['Eye pruritus', 'Eye swelling', 'Swelling of eyelid', 'Urticaria']",1,MODERNA,IM 926281,,60.0,F,Burning starting at left ear and radiating down to jaw.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,,,,,,"['Burning sensation', 'Ear discomfort']",1,MODERNA,IM 926282,NY,39.0,F,"Increased heart rate, tongue and lip swelling, dizzyness, sweating.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,"Aubagio, Metoprolol, Sertraline, Gabapentin, Birthcontrol, Vitamin D, Lactobacillus",,Multiple Sclerosis,,Copaxone allergic reaction,"['Dizziness', 'Heart rate increased', 'Hyperhidrosis', 'Lip swelling', 'Swollen tongue']",1,MODERNA,IM 926283,NV,31.0,M,"Administration error: Pfizer vaccine given as dose 1 on 12/17/2020, Moderna vaccine given as dose 2 on 1/7/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,None,None,None,,None,['Interchange of vaccine products'],2,MODERNA,IM 926284,IN,40.0,F,"Headache, Clammy Skin, Dizziness, Lower extremity Weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Cold sweat', 'Dizziness', 'Headache', 'Muscular weakness']",1,MODERNA,IM 926285,NV,66.0,F,"The patient states on 12/18/2020 at approximately 1430 a rash on both arms appeared. The rash has lasted several weeks. The rash continues to be present on 01/06/2020. No itchiness. Patient also states on 12/18/2020 at approximately 1700, she started with chills which got progressively worse throughout the evening, fever (99.8 F), patient states this temperature is 'high' for her, body aches, shortness of breath and a cough. All these symptoms got worse enough where she thought she had to call 911. However, the symptoms eventually subsided that night and she did not need to call 911. The body aches, chills and ""fever"" lasted for about 2 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,None,None,No,,"Anaphylaxis to bee stings, anaphylaxis to cephalexin, rash to ondansetron IV","['Chills', 'Cough', 'Dyspnoea', 'Pain', 'Pyrexia', 'Rash']",1,PFIZER\BIONTECH,IM 926286,WI,49.0,F,"Raised, red, warm and itching at the injection site starting on 1-6-2021. No treatment 1-7-2021 same symptoms other than a little less itching",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/06/2021,6.0,PVT,birth control pills (Emoquette) simvastatin 20 mg (Zocor) multi vitamin calcium supplement Osteo Bi-Flex,None,mild hyperlipidemia palpitations family history of CAD colon adenomas,Once in 20+ years had flu like symptoms after a influenza vaccine. Approximately 19 years ago. Age 30. Have had many influenz,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 926287,NY,64.0,F,Patient received vaccine at 1130 and immediately felt dizzy per patient. She did not state this to registered nurse at the time. Patient waited the 15 mandatory minutes and then reported back to work which is upstairs. At 1400 patient reported back down stating she had blurry vision. She was asked to sit and be monitored again and writer did this form. Patient stated her vision is blurry on and off and has not improved. Patient was evaluated and vital signs normal which patient concurred with. She was advised to follow up with primary or emergency care. Patients daughter works here as well and was agreeable to have patient be evaluated by HCP in ED to rule out any other causes.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,"mexotrexate, calcium with d, atorvastatin, prozac, propranolol, osteo biflex, fish oil",none,"hypertension, high cholesterol,",,no,"['Dizziness', 'Immediate post-injection reaction', 'Vision blurred']",1,MODERNA,IM 926288,UT,29.0,F,"generalized itchiness, itchy scratchy throat, vertigo. She was monitored for 2 hours and these symptoms resolved with 50mg oral Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Claritin 10mg, Benadryl 50mg",None,seasonal/environmental allergies; GERD,,"Nickel, NSAIDS, seasonal/environmental allergies; history of immunotherapy","['Pruritus', 'Throat irritation', 'Vertigo']",1,MODERNA,IM 926289,FL,57.0,F,"Severe headache, severe sore throat, severe body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,No,None,None,,None,"['Headache', 'Oropharyngeal pain', 'Pain', 'Pharyngitis streptococcal', 'Streptococcus test positive']",1,MODERNA,IM 926290,MI,23.0,F,"Presented to ED 1/3/2021 Tachycardia, fever, headache and myalgia. Complaints of shortness of breath.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,PVT,None,Covid positive within 3 weeks of vaccine,None,,None known,"['Angiocardiogram', 'Blood lactic acid', 'Dyspnoea', 'Electrocardiogram', 'Full blood count', 'Headache', 'Metabolic function test', 'Myalgia', 'Pulmonary embolism', 'Pyrexia', 'Tachycardia']",1,PFIZER\BIONTECH,IM 926291,TX,56.0,F,"Extreme body ache, intermittent chills,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,PVT,"Amlodipine, Labetalol",none,high blood pressure,reports flu like symptoms p flu vaccine,"Sulfa, erythromycin, avocado","['Chills', 'Pain']",1,MODERNA,IM 926292,OK,58.0,F,"NAUSEOUS, MUSCLE ACHE, FEVER, HEADACHE, SORE AT INJECTION SITE AND UNDER ARM AREA",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PUB,"SYNTHYOID, LEVERTHYROXIN, VALSARTIN, AMLODIPIN, FLUXETINE, DELUXETINE",NONE,"ASTHMA, ARTHRITIS",,NONE,"['Axillary pain', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Pyrexia']",UNK,MODERNA,IM 926293,IL,55.0,F,"Dizziness, slight headach and tiredness. The dizziness and started the day after 01-06-21 and the tiredness started 01-07-21. I, also, had a shingles vaccine 15 days prior to taking this vaccine which i told them about and wrote on my form.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,WRK,"Metformin, atorvastatin, triamterene-hctz, fluticasone propionate, breo ellipta 200/25, and albuterol","Asthma, hypertension, type 2 diabetes and hx of rectal cancer",Asthma,,Lactose,"['Dizziness', 'Fatigue', 'Headache']",1,MODERNA,IM 926294,OK,45.0,F,"12/31/2020: Around 2pm, feeling dizzy and rapid heartbeat. 3:30pm, rapid heartbeat. 6pm rapid heartbeat 01/01/2021: 6am, rapid heartbeat. 8pm, rapid heartbeat 01/02/2021: 8am, rapid heartbeat. 2pm, rapid heartbeat 01/03/2021: 1:30pm, rapid heartbeat lasted until around 3pm. 01/04/2021: 7am, rapid heartbeat. around 8pm, rapid heartbeat. 01/05/2021: 10am rapid heartbeat The first two days I experienced the rapid heartbeat, I almost had an anxiety attack but I learned to breath through my nose and I would be okay after that. Today is January 7 and i haven't experienced anything in the last two days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Singular, Wixela, Albuterol inhaler, Potassium, water pills and Centrum vitamins",None.,Asthma,,None.,"['Dizziness', 'Heart rate increased']",2,PFIZER\BIONTECH,SYR 926295,MN,17.0,F,"Patient was given Moderna vaccine, but was found that she was only 17 during billing process.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,SEN,unknown,unknown,unknown,,unknown,['Product administered to patient of inappropriate age'],1,MODERNA,IM 926296,FL,29.0,F,"Fever, chills, sweats, loss of appetite. Note: i previously had Covid in June 2020 so I wonder if that?s why I has a bigger reaction to the vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,Birth control,,,,Sulfa,"['Chills', 'Decreased appetite', 'Hyperhidrosis', 'Pyrexia']",1,MODERNA, 926297,CA,38.0,M,"Fever(38C), muscle aching, lethargy,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Multiple vitamin,No,"HIV, undetectable",,No,"['Lethargy', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 926299,UT,29.0,F,"Generalized itching, scratchy itchy throat, vertigo. She was monitored for 2 hours and symptoms resolved with 50mg oral benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Claritin 10mg, Benadryl 50mg",None,Seasonal/Environmental Allergies; history of immunotherapy,,"Nickel, NSAIDS","['Pruritus', 'Throat irritation', 'Vertigo']",1,MODERNA,IM 926300,NJ,31.0,M,"Facial palsy, feeling cold, oral numbness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PUB,,,,,,"['Facial paralysis', 'Feeling cold', 'Hypoaesthesia oral']",1,MODERNA,IM 926301,NC,38.0,F,"right 2nd toe numbness that spread to great toe and then midfoot. The next day the left foot was numb. Some paresthesias in hands but that quickly resolved. Right foot still feels ""asleep"" most of the time, regardless of positioning. No weakness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/23/2020,2.0,WRK,none,none,none,,none,"['Hypoaesthesia', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 926302,CA,32.0,M,"c/o ""itchiness"" on arm and back; observed red raised descending rash from nape of neck to lower back and banding clavicle area; elevated B/P 167/111 HR 89/79; became anxious and diaphoretic; declined treatment/transport to ED however agreed to walk over to ED accompanied by RN. Evaluated by ED Triage RN , not checked in ED. Also reported has chest tightness with reaction. Patients reported ED doctor told him to take Benadryl. But he was working and wanted to continue to work so took Zyrtec instead. Still have the rash just above the injection site?comes and goes.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,PVT,Stopped taking in October-- Losartan. No others.,,"hypertension, anxiety, hx of skin cancer two times, history of allergic reactions which epi-pens were described for some.",,"Shells fish, bee stings, (an antibiotic), and a lot environmental allergies.","['Anxiety', 'Chest discomfort', 'Hyperhidrosis', 'Hypertension', 'Injection site rash', 'Rash', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",1,PFIZER\BIONTECH,SYR 926303,CO,38.0,F,"After 1 week of no problems, Cellulitis in left hip (injection site) treating with Augmentin.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,"Elmiron, omeprazole, zyrtec, Wellbutrin, cymbalta, fish oil, probiotic, Vit D",None,"Fibromyalgia, chronic major depression",,Sulfa,['Injection site cellulitis'],1,MODERNA,IM 926304,FL,75.0,F,"Chills, headache, diarrhea, muscle pain 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,Lisinopril/HTC20-12.5 ARMOUR Thyroid 60mg Metoprolol Tart 50mg Zyrtec Bayer Aspirin low dose,no,no,,Codeine,"['Chills', 'Diarrhoea', 'Headache', 'Myalgia']",1,MODERNA,SYR 926305,IL,73.0,M,"Injection Site: Swollen and Pain-it seems it lasts longer than 24 hours. At the time of this report, S/S still continue. Fever, Muscle pain, Malaise, Headache All longer than expected",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,OTH,None,None,HTN,,None,"['Headache', 'Injection site pain', 'Injection site swelling', 'Malaise', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 926306,VT,22.0,F,"I received the Moderna COVID vaccine on 12/29. I had some minor swelling and soreness the first couple days after receiving the vaccine, but these symptoms both went away after a couple of days. A week later on 1/5, I noticed that the area where I had been injected was very swollen, red and itchy. It was localized to this year. There was some slight bruising around the top of where the swelling started. The area was not sore. There is still some redness and itching on 1/7 but the swelling has mostly gone down. I work in a community health center and had a PA I work with look at the reaction. I took some Benadryl as directed on 1/5 but have not treated the symptoms further.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PUB,ethinyl estradiol; norgestimate birth control,None,None,,None,"['Injection site bruising', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Pain', 'Swelling']",1,MODERNA,IM 926307,OH,45.0,F,"woke up at 0400 on 1/7 with headache, low grade temp (99.8), chills, and as day went on I became nausea, tired and my joints in my hips ached along with my back and neck. I got home from work took 2 Tylenol and slept from 7pm till 4am on 1/8. on 1/8 I woke feeling back to normal minus some arm tenderness and a small red circle at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,WRK,"multi vitamin, v-d, omeprazole, iron, B12",none was positive for covid-19 10/10/20,none had weight loss surgery 2yrs ago,,nka,"['Arthralgia', 'Back pain', 'Chills', 'Fatigue', 'Headache', 'Injection site erythema', 'Nausea', 'Neck pain', 'Pyrexia', 'Tenderness']",UNK,MODERNA,SYR 926308,ME,53.0,F,"Arm became red, itchy and warm one week post vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/25/2020,01/02/2021,8.0,PVT,,,,Influenza Vaccination,,"['Erythema', 'Pruritus', 'Skin warm']",UNK,MODERNA,IM 926309,LA,35.0,F,"Fever 102.4, severe fatigue, chills, aches, HA; Tylenol with reduced fever. Fever for 24 hours, symptoms gradually resolved in 3 days from initiation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/15/2020,12/16/2020,1.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 926310,,42.0,F,"I had visual aura with migraine which is a normal event for me. This time, however, it was accompanied by confusion and memory loss that lasted about 15 minutes. I couldn?t say names of people known to me or read a list on my counter. In 25 years of migraines I have never had these symptoms with my migraine. I took an over the counter migraines medicine which resolved the symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/19/2020,2.0,PVT,None,None,History of migraines,,None,"['Amnesia', 'Confusional state', 'Migraine with aura']",1,PFIZER\BIONTECH,IM 926311,VT,43.0,F,"Body aches and chills, no fever. Felt poorly. Sent home from her shift.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Chills', 'Feeling abnormal', 'Impaired work ability', 'Pain']",UNK,PFIZER\BIONTECH, 926312,MI,30.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 17 hours post vaccination, I woke with moderate body aches, moderate headache, moderate congestion, mild chills (NO fever), mild nausea, and significant overall fatigue. Symptoms ongoing for 8 hours, however chills and nausea are gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,OTH,,Mild sinus congestion and pressure,,,,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Respiratory tract congestion']",1,PFIZER\BIONTECH,IM 926313,MI,46.0,F,"I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on the 3rd and 4th day, I had chest pain radiating to left arm and jaw. Fever and chills reported 100.2 in fever. Severe right arm pain. I have difficulty lifting objects. I have recovered from the chest pain and abdominal pain but the arm pain is still bothersome and continues to be hurtful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/26/2020,4.0,PVT,"Vitamin D., Vitamin C, Eldererry",No,No,,"Medications (Amoxicillin, Ketoconazole)","['Abdominal pain', 'Blood test', 'Chest pain', 'Chills', 'Computerised tomogram abdomen', 'Mobility decreased', 'Pain in extremity', 'Pain in jaw', 'Pyrexia', 'Urine analysis']",1,PFIZER\BIONTECH,IM 926314,IL,33.0,F,"Pt stated that her arm started to fell heavy and then her chest, throat felt ""itchy"". Heart rate was 96-104, blood pressure 140/100, SpO2 100%. Rested with legs elevated. Benadryl 25 mg 1 tab given. Nurse Practitioner evaluated pt. Lungs clear, symptoms improved and was sent home after 1 1/2 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PUB,unknown,unknown,unknown,,none,"['Chest discomfort', 'Limb discomfort', 'Throat irritation']",1,MODERNA,IM 926315,MD,58.0,F,"Extreme sharp throbbing pain in left arm at injection site. Unable to move top half of my arm without stabbing pain. .Have to keep my arm straight at my side. I can bend at the elbow, as long as I don't move upper arm. Soreness from wrist to neck and shoulder. I first noticed the pain and stiffness about 5 hours after shot, and then it increased and was extremely painful and I was unable to sleep lying down. Had to sit up in a recliner most of the night. Arm continues to have sharp , stabbing, throbbing pain 24 hours later",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,OTH,"Levothyroxine and Lexapro. Vitamin D3, B Complex, and iron.",None,None,,None,"['Arthralgia', 'Injected limb mobility decreased', 'Injection site pain', 'Musculoskeletal stiffness', 'Neck pain', 'Pain', 'Pain in extremity', 'Sleep disorder']",1,MODERNA,IM 926316,NC,55.0,F,"Swollen, sore lymph nodes",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,PVT,Escitalopram Bupropion Zyrtec Levothyroxine Saxenda,None,none,,Pine nuts,"['Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 926317,OH,55.0,F,"I awoke at 3:30am in severe, excruiting pain in entire left arm! I took some ibuprofen and propped arm on pillow to relieve pain. Did not work at all! Reported off of work at about 4am. Waited until appropriate hour and called Nurse Access hot line. I notified of symptoms of swelling of left side, face, neck, shoulder, arm to finger tips. itchy watery eyes , a little nausea and headache. Was advised to contact Doctor for appt. Doctor had no available appointments and advised to go to urgent care. Went to Urgent care and was treated with steroid shot and given Tylenol, benedryl, and Pepcid oral medications. Dr. prescribed prednisone 20mg twice daily along with Tylenol, Pepcid, Flonase, clariton and benedryl as nee",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,,,,,,"['Eye pruritus', 'Headache', 'Impaired work ability', 'Lacrimation increased', 'Nausea', 'Pain in extremity', 'Peripheral swelling', 'Swelling', 'Swelling face']",1,MODERNA,IM 926318,GA,49.0,F,"Nausea, Headache, Weakness, Shortness of breathing, elevated heart rate, light-headed. Just felt bad (Still having some of these problems)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Tylenol,"Some headaches, shortness of breath, some dizziness",,,"Brand Ultracet, Triptan family, Iodine, Shellfish & Chocolate","['Asthenia', 'Dizziness', 'Dyspnoea', 'Feeling abnormal', 'Headache', 'Nausea', 'Tachycardia']",2,PFIZER\BIONTECH,IM 926319,NH,42.0,F,"On day 7 post injection- developed redness, swelling, itching and hard lump. On day 9 symptoms increased and size of redness spread to 3 inches in diameter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,Latuda Lithium Atorvastatin Pristiq CoQ10 Fish Oil Magnesium Turmeric,,Bipolar Sacroiliitis Chronic Migraines,,,"['Injection site erythema', 'Injection site induration', 'Injection site mass', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 926320,WI,44.0,F,"Received Moderna vaccine on 12/28/20. Patient texted me a picture of her arm which is swollen, red and indurated. Induration measures 3x4 inches. Also complained of itching. Has used hydrocortisone cream with no improvement.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/01/2020,,PVT,,,,,,"['Erythema', 'Induration', 'Peripheral swelling', 'Pruritus']",1,MODERNA,IM 926321,SD,38.0,F,"Received Vaccination on 12/23/2020; mild headache and tiredness on 12/24 and 12/26. 1/3/2021 swelling, redness, and itching localized to injection site Sought medical advise on 1/6/2021; prescribed hydrocortisone 2.5%, Claritin, Pepcid and Benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/03/2021,11.0,PVT,None,None,Gastroesphageal reflux disease with esophagitis,,,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 926322,MN,17.0,F,Patient was 17 years old,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,SEN,unkown,unkown,unkown,,unkown,['Product administered to patient of inappropriate age'],1,MODERNA,IM 926323,ME,50.0,F,"Site of injection became red, itchy, and warm with a hard spot",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,01/03/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",UNK,MODERNA,IM 926324,NY,64.0,F,"Five minutes after receiving the Pfizer Covid-19 vaccine, the pt. informed the RN that she was feeling ""itchy"" on her right arm, her right scapula and across her abdomen. She was given the vaccine in her left arm. The pt did not have any rash or hives noted. The PA spoke with the pt and 50 mgs Benadryl was given p.o.(@ 1450). The pt stayed to be observed and after an additional 40 minutes (@ 1531) she said she was feeling better and was going to her unit to work (eve shift). The pt. spoke to her Nurse Manager upon arrival back to her unit and was sent home instead of working. Her unit was called at 4pm and we were informed that the pt went home, as she was concerned of being too tired to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,None,None,None,,None,"['Impaired work ability', 'Pruritus']",1,PFIZER\BIONTECH,IM 926325,MI,30.0,F,"Headache back of neck, twmples and eyebrows, really sore injection site. Fatigue, Malase, nausea off and on, decreased appetite. Feeling dehydrated, chills/ at times painful sensitive skin similar to the flu. Muscle aches throughout the body.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,"Omega-3, Vit D 250mcg, sprintec 28day,",None.,"Hx Asthma, Eczema, Major Depression.",,Citrus fruits,"['Chills', 'Decreased appetite', 'Dehydration', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Myalgia', 'Nausea', 'Neck pain', 'Pain of skin']",1,PFIZER\BIONTECH,IM 926326,CA,44.0,F,"Facial numbness bilaterally with headache 3 hours post injection. 15 hrs post injection: 101 temperature, severe chills and joint pain (making it difficult to walk), body aches and extreme fatigue. Headache continued but facial numbness subsided. Symptoms less severe at 48hrs, low grade temp and body aches persisted, joint pain resolved. All symptoms resolved at 72 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Bupropion HCL 150mg BID,None,None,,None,"['Arthralgia', 'Body temperature increased', 'Chills', 'Fatigue', 'Gait disturbance', 'Headache', 'Hypoaesthesia', 'Pain']",2,PFIZER\BIONTECH,IM 926327,VA,61.0,M,Patient reports low back pain fever and anxiety began 2300 on the day of vaccination. He states he is unable to sleep and feels an adrenaline rush but denies shortness of breath or chest pain. The fever and back pain resolved over the subsequent days however the jittery feeling persisted and he presented to the ED 1/6/2021. Patient was treated to diphenhydramine and symptoms resolved,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Aspirin 325 mg daily Atenolol 25 mg daily atorvastatin 10 mg daily esomeprazole 40 mg daily tadalafil 5 mg daily,,"Afib, HTN",,NKA,"['Anxiety', 'Back pain', 'Electrocardiogram', 'Feeling jittery', 'Full blood count', 'Insomnia', 'Metabolic function test', 'Pyrexia', 'Urine analysis']",UNK,MODERNA, 926328,KY,48.0,F,"Vomiting and Diarrhea 20 times, fever 103, redness at injection site, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,none,Covid test pending,None,,Allergy to K-Flex,"['Diarrhoea', 'Injection site erythema', 'Laboratory test', 'Myalgia', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test', 'Vomiting', 'X-ray abnormal']",1,MODERNA,IM 926329,NJ,42.0,M,Maculopapular rash on both upper extremities with itching,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/31/2020,30.0,PVT,"Claritin, Vit C, Vit D",None,None,,None,"['Pruritus', 'Rash', 'Rash maculo-papular']",1,PFIZER\BIONTECH,SYR 926331,IN,58.0,M,Extreme injection site pain. Headache. Nausea. Chills. Fever to 101 F. Fatigue. Muscle and joint pain. Loss of appetite. Still ongoing on day 2. I wonder if people who have had the virus should be being told to get the vaccine since I suspect intense reaction is due to pre existing immunity.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Metformin. Lisinopril. Metoprolol. Jardiance. Atorvastatin. Basaglar. Aspirin,None,Diabetes. Tachycardia,,None,"['Arthralgia', 'Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,IM 926332,MA,25.0,F,"About 9 hours after receiving the vaccination (11:30 pm on 1/6/21), I developed fatigue, fever of 100.0 F, body aches, bone pain, mild chills, and mild nausea. I also have moderate left arm pain where I received the vaccine. It is now 3:00pm 1/7/20 and the fever, chills, nausea, and body aches have subsided, however the fatigue and left arm pain still persists.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,UNK,Sronyx (oral contraceptive),None,None,,No,"['Bone pain', 'Chills', 'Fatigue', 'Injection site pain', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 926333,NY,54.0,F,"Subject received vaccine at 0845 in 1/6. Felt chest tightness, cough wheezing 15-20 min later. Took personal albuterol inhaler and waited in car 50 minutes Reported to employee health office Sent to ED for SOB, wheezy, tingling in tongue per MD note. (arrived 0958) Nebulizer administered. Chext X-ray negative for acute disease. ED MD states: Asthma exacerbation Left 1143",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Not recorded at this visit,,"Asthma, Diabetes mellitus, Endometriosis, Migraine, Osteoarthritis, Ovarian cyst, Psoriasis",,Not recorded at this visit,"['Asthma', 'Chest X-ray normal', 'Chest discomfort', 'Cough', 'Dyspnoea', 'Paraesthesia oral', 'Wheezing']",1,PFIZER\BIONTECH,IM 926334,AL,57.0,F,"CHILLS, FEVER, BODY AND HEAD ACHES",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,,NONE,RHEUMATOID ARTHRITIS AND HEART DISEASE,,SULFA,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 926335,ME,43.0,F,"Site of injection became red, itchy, warm and tender. It got larger over a two day period.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,01/03/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",UNK,MODERNA, 926336,MI,21.0,F,Body aches and chest pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/04/2021,2.0,PVT,Flonase Albuterol Adderal,Covid positive one month prior Acute pharyngitis 3 days prior to vaccination,asthma,,Sulfamethoxaxole Bactrim Codiene Aluminum Chloride Keflex Macrobid,"['Chest pain', 'Electrocardiogram', 'Full blood count', 'Metabolic function test', 'Pain']",1,MODERNA,IM 926337,NJ,57.0,F,Synovitis both knees which have knee replacements,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,WRK,"Synthroid, Prozac, Dexilant, Activella, Claritin D",None,"Hypothyroidism, Osteoarthritis, GERD, anxiety",,"Penicillin, Morphine","['Synovitis', 'X-ray']",1,MODERNA,IM 926338,UT,25.0,F,"?Moderna COVID-19 Vaccine EUA? The day I got the vaccine all that happened was a dead arm and then when I was driving home after the 15 minutes of waiting in the parking lot, I got a metallic taste in my mouth, but it didn't last very long. The next day my arm was sore to move, but not at the injection spot, if looking at my arm (someone else) it was down 3 inches and to the left about 1 inch. The next day that same spot was still sore but to the touch, then it went away. What is more interesting and concerning is that on 1/6/2021 (a week after I got the shot), I noticed 3 little bumps on my arm (9:45pm), in that same location that was sore to move and touch on day 2 and 3 but they also were itchy. When I woke up the next morning (6:15 am) the area had spread to the size of my palm (3 inch by 3 inch roughly) it was all red, hard to the touch, stilly itchy and I had the feeling of a dead arm again. One of the nurses at my work drew a circle around the red spot so we could watch to see if it was still growing , by roughly 11:45 am it had grown an additional 2 inches.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,WRK,None,None,None,,None,"['Dysgeusia', 'Injected limb mobility decreased', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site reaction', 'Pain', 'Pain in extremity', 'Rash pruritic']",1,MODERNA,IM 926339,OH,51.0,M,"The following day in the afternoon, I began have soreness in my muscles and body aches, then a headache. Short time later I began have an upset stomach all while having a running nose. A few hours later I had some diarrhea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PUB,"Valsartan, Levothyroxine, Testosterone",,,,,"['Abdominal discomfort', 'Diarrhoea', 'Headache', 'Myalgia', 'Pain', 'Rhinorrhoea']",UNK,MODERNA, 926340,MI,22.0,M,"At 2300 hours on 1/6/2021, I began to feel chills and was spiking a fever. At 0030 on 1/7/2021, I experienced nausea and vomiting. I subsequently experienced three additional episodes of nausea and vomiting throughout the night until 0500 on 1/7/2021. I had a fever until 1400 on 1/7/2021. I did not treat my fever until 1300 on 1/7/2021, at which time I took 15 mL of children's ibuprofen by mouth. As of 1500 on 1/7/2021, I feel weak and my nausea and vomiting has not returned.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,None,None,None,,None,"['Asthenia', 'Chills', 'Nausea', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 926341,MO,37.0,F,"Patient stated she had severe diarrhea and vomiting approximately 2 hours after she received the vaccine. She went to a walk-in clinic and they gave her benedryl 12.5mg and Zofran 4mg. She was not feeling better, and later went to the ER where she received 1000ml of Normal Saline, Tylenol 650mg and Zofran 4mg",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,none reported,none reported,none reported,,none,"['Diarrhoea', 'Malaise', 'Vomiting']",1,PFIZER\BIONTECH,IM 926342,VT,42.0,F,Tolerated vaccine and 15 minute wait with no issues. Went home and noticed widespread hives. Took 50 mg of Benadryl at home and hives resolved. No other symptoms. Worked normal shift today,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,['Urticaria'],UNK,MODERNA, 926343,CA,53.0,F,tingling in ankle down to toe,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,"Vitamin D, omeperozole, pantoprazole",none,"GERD, acid reflux, IBS,",,ampicillin,['Paraesthesia'],1,MODERNA,IM 926344,SC,48.0,F,"I received my covid -19 vaccine at work at hospital. I sat for my fifteen minutes after vaccination and felt fine. When I got home two hours later from work and got in the shower, I noticed that I had a red, slightly raised, pinpoint and very defined red rash. The rash was all over my abdomen, my back and my neck. The areas felt warm but I did I not have itching, pain or any other anaphylaxis symptoms. The rash faded entirely in the next 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,None,None,None,,None,"['Rash', 'Rash erythematous', 'Rash papular', 'Skin warm']",1,PFIZER\BIONTECH,SYR 926345,CA,29.0,F,"Patient describes soreness on the arm that is hot to the touch, headache, she took Tylenol, body sweats and nausea and also reports sore throat. Patient reports she is having all symptoms except arm soreness.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/01/2021,2.0,WRK,,,,,,"['Headache', 'Hyperhidrosis', 'Nausea', 'Oropharyngeal pain', 'Pain in extremity', 'Skin warm']",UNK,MODERNA, 926347,CA,46.0,F,"Day 1: strong ache in all joints, mild nausea, headache Day 2: swollen lymph nodes in left arm & neck, severe back ache low temp 99-100.3 Day 3: @ 0300 fever 101.5, chills (rigors 3hrs), very bad headache, neck pain, joints and lymph swelling. Had both regular and Rapid covid test and rapid was negative. Awaiting FLU swab and regular Covid test. Day 4: continued fevers 99-100.9, back and neck pain, milder headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,WRK,"Claritin, pepcid, ibuprofen",None,None,,"Sulfa, erythromycin","['Arthralgia', 'Back pain', 'Chills', 'Headache', 'Influenza virus test', 'Lymphadenopathy', 'Nausea', 'Neck pain', 'Pyrexia', 'SARS-CoV-2 test', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 926348,CA,34.0,F,"Developed arm pain and nausea in the evening after an afternoon vaccination. Resolved somewhat with acetaminophen, famotidine, Tums, ginger ale, and bed rest. Arm pain worsened by morning and nausea delayed ability to eat breakfast. Resolved somewhat again with acetaminophen and famotidine, but worsened throughout the morning. Developed mild chills and fatigue throughout the morning as well. Pregnancy information: 31 weeks and 1 day pregnant at time of administration. Little to no nausea after first trimester. Diagnosed with gestational diabetes early in second trimester. Currently well-controlled with diet/exercise. Due date 3/9/21. Encouraged by OB to receive vaccine. Still planning on receiving 2nd dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,"Prenatal vitamins, loratadine, famotidine intermittently, Tums intermittently",Gestational diabetes,"Intermittent GERD, overweight, PCOS",Arm pain with previous flu vaccines and Tdap vaccines,Penicillins and macrolides/ketolides,"['Chills', 'Exposure during pregnancy', 'Fatigue', 'Nausea', 'Pain in extremity']",1,MODERNA,IM 926349,MD,37.0,F,Several minutes after the vaccination was administered she began experiencing numbness and tingling down her right arm to her fingers.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 926350,MI,62.0,F,Left arm started yesterday after injection was completed on 12/28/20 with red itchy rash.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,SEN,Acetaminophen,Urinary Tract Infection,"CVA, Hemiplegia, hemiparesis, dysphagia , hypertension, GERD, osteoporosis, cardiac murmur, depression",,NKA,"['Injection site reaction', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 926351,OK,29.0,F,"Fever of 101, chills, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 926352,NY,36.0,F,"36F w/ Hx of HTN w/ HA and dizziness following COVID vaccine dose today. Symptoms began about 7 minutes post vaccination, no airway complaints, vomiting/nausea/abdominal pain, no chest pain, wheezing or SOB, no rash. VS wnl throughout course of observation in vaccine POD. Airway intact, no stridor, no signs of respiratory distress. Given PO fluids. Symptoms persisted resulting in transfer to Emergency Department for further evaluation and monitoring. Did not require additional interventions or any medications while in vaccine POD.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,unknown,none,hypertension,,NKDA,"['Dizziness', 'Headache']",1,PFIZER\BIONTECH,IM 926353,NC,24.0,F,"lip/tongue swelling, tingling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,,,"obesity, anxiety",,contrast dye,"['Lip swelling', 'Paraesthesia', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 926354,IN,51.0,F,"Patient started experiencing extreme fatigue and headache on 1/6/2021. She arrived at work on 1/7/2021 and was experiencing extreme fatigue, severe headache, welts, naussea, and feeling of walking on broken bones. Patient was advised to go home from work.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PUB,Unknown,none,"Obesity, Diabetes, Other","After initial dose of covid-19 vaccine, the patient experienced severe headache, and fatigue",none,"['Fatigue', 'Gait disturbance', 'Headache', 'Impaired work ability', 'Nausea', 'Urticaria']",2,PFIZER\BIONTECH,IM 926355,CA,57.0,F,Red silver dollar sized circle on her arm,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,UNK,,,,,,['Erythema'],1,MODERNA,SYR 926356,,43.0,F,"states that she has severe itching on left arm, radiating to back. Taken to private observation area with EMT staff. Has hives on left side of back and left arm. Very itchy. 1055 BP 138/98; HR 98; 96% sats on r/a; RR 20. 1058 gave benadryl 50 mg by mouth. Gave ice pack for itching. Place on left side of back with raised red papule. States relieves itching. Continued to observe. 11:02 BP - 124/88; P- 90 strong and regular; 99% sats on r/a. Swelling decreasing, no signs of severe allergic reaction. Papules decreasing in redness. 11:15 Left side itching, redness and papules diminished. Now has them present on right arm and right upper back. P-89; sats 98% on r/a RR-16. 11:18 c/o swelling under left side of tongue with red raised papules on face and head. EMT called ambulance. 1122 unit arrived. 1140 Patient declined transport. Husband with patient. Husband states he is transporting patient per personal vehicle to hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,Albuterol as needed; EPI pen not used since a teenager,no,Asthma,,"Iodine, wheat, milk, zucchini, pet dander","['Erythema', 'Papule', 'Pruritus', 'Swelling', 'Swollen tongue', 'Urticaria']",1,MODERNA,IM 926357,MA,64.0,F,"Sensation in throat, followed by mild SOB, and seemingly troubles ?clearing? throat. Took a Claritin about 45 mins after injection with complete symptom relief",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Lipitor, ASA, Multi-Vit, L-Carnidine, Calcium, Vitamin D, Chromium Picolinate, Lexapro",None,Cough-variant Asthma,,"Biaxcin, Tetracycline, Simvastatin","['Dyspnoea', 'Throat clearing', 'Throat irritation']",UNK,MODERNA,SC 926358,KY,66.0,M,"Developed body rash right after the vaccine, joint pain. Tested positive for COVID about five months ago.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,WRK,"Atorvastatin, Plavix, Celebrex","joint and muscle pain, swelling in hands and wrists",cardiovascular disease,,no,"['Arthralgia', 'Rash']",1,MODERNA,IM 926359,MN,45.0,F,around 1500 Vomited x 1; HTN 190's/ 116-118; flush cheeks bilaterally; dizzy; weak;,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,,,HTN nighttime insomnia right shoulder pain,,methylprednisolone,"['Alanine aminotransferase normal', 'Anion gap normal', 'Aspartate aminotransferase normal', 'Asthenia', 'Basophil count normal', 'Basophil percentage', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bilirubin normal', 'Blood calcium decreased', 'Blood chloride normal', 'Blood creatine phosphokinase normal', 'Blood creatinine normal', 'Blood glucose normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea nitrogen/creatinine ratio', 'Blood urea normal', 'Carbon dioxide normal', 'Condition aggravated', 'Dizziness', 'Eosinophil count decreased', 'Eosinophil percentage decreased', 'Flushing', 'Glomerular filtration rate normal', 'Haematocrit normal', 'Haemoglobin normal', 'Hypertension', 'Lymphocyte count normal', 'Lymphocyte percentage', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Mean platelet volume increased', 'Monocyte count normal', 'Monocyte percentage', 'Neutrophil count', 'Neutrophil count normal', 'Neutrophil percentage', 'Platelet count normal', 'Protein total normal', 'Red blood cell count normal', 'Red cell distribution width normal', 'Vomiting', 'White blood cell count normal']",1,PFIZER\BIONTECH,IM 926360,OK,26.0,M,"Marked increase in seizure activity. I seizure on 1/2/21, then a cluster of about 20 e\seizures on 1/3/21, followed by 3 seizures on 1/5 and 2 on 1/6. He was seizure free for approximately 10 months prior to vaccination.. Treated on 1/3 with Nayzilam nasal spray X2 to stop seizures per doctor's order.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/03/2021,3.0,OTH,"Briviact, Clobazam, Linzess, Omega-3, Polyethylene glycol, Vimpat",,"Developmental delay, Epilepsy/seizures, gastroparesis, esophageal reflux,",,Lamictal,"['Condition aggravated', 'Seizure']",1,MODERNA,IM 926361,VA,36.0,F,"I have intense burning sensation in my left buttock cheek and thigh but no rash. I went to my gynecologist , first thinking I may have a yeast infection but she did not see a rash and couldn't diagnose me. She told me that my pain was probably neurological. She took my blood and sent it to a lab for possible yeast infection and STDs. She prescribed me Clotrimazole and Betamethasone Diporopionate 1%. I went to my PCP on Wednesday because the burning intensified and I thought that I may have shingles. I have a stuffy nose and my sense of smell isn't very good right now. My PCP gave me a Covid test and told me that she can not test me for shingles because I do not have a rash. She did prescribed me Gabapentin 100mg . I am awaiting Covid test and Lab results",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/05/2021,3.0,PVT,none,none,none,,none,"['Anosmia', 'Burning sensation', 'Nasal congestion', 'Pain', 'SARS-CoV-2 test']",1,MODERNA,SYR 926362,OH,39.0,F,Approximately 20 minutes after receiving the COVID vaccine my face became numb. The numbness gradually increased until I could not feel the right side. Numbness lasted approximately 4 hours. My eye also began to twitch as well. The eye twitching is still an issue.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/28/2020,0.0,PVT,,,,,,['Hypoaesthesia'],1,MODERNA,IM 926363,LA,58.0,F,"sweats, chills, headaches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,none,none,"htn, hyperlipidemia, Gerds,",,none,"['Chills', 'Headache', 'Hyperhidrosis']",2,PFIZER\BIONTECH,IM 926364,PA,49.0,F,"12/31/20- fever, headache, arm stiffness 01/06/21-enlarged axillary lymph nodes ipsilateral 01/07/21- rash, itching, swelling of injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PVT,"Estrogen, progesterone, testosterone, armor thyroid, centrum multivitamin, vitamin D, Allegra, Benadryl",None,None,,"Gluten sensitivity, seasonal allergies, sulfa drugs","['Headache', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Lymphadenopathy', 'Musculoskeletal stiffness', 'Pyrexia']",1,MODERNA,SYR 926365,CA,25.0,F,"Experienced stomach upset, nausea, fever 101.4, body aches, inability to focus",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,WRK,vitamin c,None,none,,None,"['Abdominal discomfort', 'Disturbance in attention', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 926366,MA,32.0,F,"Significant swelling (15cm in diameter), redness, warmth, pain on left arm worsened at day 8 post vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/04/2021,6.0,UNK,,,,,,"['Erythema', 'Pain in extremity', 'Peripheral swelling', 'Skin warm']",1,MODERNA,IM 926368,IL,25.0,F,"Received second vaccine on 01/04/21 at 1230 and began having axillary lymph node swelling and tenderness the following morning (01/05/21) along with headache and severe fatigue. Fatigue and headache have subsided, but axillary swelling remains. Axillary tenderness beginning to subside.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/08/2021,4.0,WRK,,,,,NKA,"['Fatigue', 'Headache', 'Lymph node pain', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 926369,CA,57.0,F,red raised silver dollar sized spot on arm,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,UNK,,,,,,"['Erythema', 'Swelling']",1,MODERNA,SYR 926370,NH,42.0,F,"Started on day 7 post injection. Redness, swelling, itching and hard lump. On day 9 the redness and itching increased and is hot to the touch. To start benadryl tonight(day 9), zyrtec in am and prednisone for 5 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,Latuda Lithium Atorvastatin Pristiq CoQ10 Fish oil Magnesium,,Bipolar Sacroiliitis Migraines,,,"['Erythema', 'Mass', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,IM 926371,WI,60.0,F,"1/6/21: Received Moderna COVID vaccine. Just wanted to let you know that I am experience some ?flu? like symptoms after my vaccination which sounds like are normal for some folks. Temp 99.6 just now was 99.1 when I came in this morning. Freezing/chills, cough, pain and redness at site, joint aches. 1/7/21 at noon temp 101.2.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Arthralgia', 'Body temperature increased', 'Chills', 'Cough', 'Feeling cold', 'Influenza like illness', 'Injection site erythema', 'Injection site pain']",1,MODERNA,IM 926372,ME,59.0,F,"Injection site became red, itchy, and swollen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/31/2020,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA,IM 926373,MA,31.0,M,"Fever (101F) , fatigue, headache, general muscle pain starting at ~4:00AM on the day after first vaccination and resolving overnight the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,WRK,,,,,,"['Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 926374,PA,31.0,M,"Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccinated 7am 1/5/21. Low fever of 99, chills, malaise, and body aches started 8pm 1/5/21. Headache around 12am 1/6/21. The date and time currently is 3pm 1/7/21 and symptoms are persisting but more mild.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,none,none,"psoriasis, COVID - 19 in September 2020",,none,"['Chills', 'Headache', 'Malaise', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 926375,FL,64.0,F,"Injection site arm is swollen, red, hot bubbly red rash around the site, hot itches. Taking Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,OTH,Losartan 100,no,no,,penicillin,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site reaction', 'Injection site swelling', 'Injection site vesicles', 'Injection site warmth', 'Rash erythematous']",1,MODERNA,SYR 926376,ME,42.0,F,"Injection site became itchy, red, warm, and sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",UNK,MODERNA,IM 926377,AZ,64.0,F,"Reported to me by onsite staff: Patient seemed to tolerate the vaccine fine at time of administration. Following day (appx 24 hours) following administration, patient was having fever and unresponsive. Patient also had local, large, hard hematoma at injection site. It is worth noting that the patient had recently completed CDC recommended isolation protocol, and was symptom free at time of administration - determining they were qualified to get vaccine. The facility is also aware that the patient's present condition could be related to an active COVID 19 infection / relapse.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/04/2021,1.0,SEN,,,,,,"['Injection site haematoma', 'Injection site induration', 'Pyrexia', 'Unresponsive to stimuli']",1,MODERNA,IM 926378,MO,42.0,F,"Nausea- 01/03/2020-01/05/2020 Fever-99.2-101.4 01/02/2020-01/05/2020 leg pain - aching in calves 01/02/2020-01/05/2020 Injection site -redness, heat, swelling and whitening around the redness 01/06/2020-present",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,PVT,Spironolactone,None,"High Blood Pressure, Diabetes",,"Codeine, coconut","['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 926379,GA,58.0,F,"QUARTER SIZE RAISED RED, ITCHY SPOT AT INJECTION SITE STARTING OVER 1 WEEK POST INJECTION",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,PVT,NO MEDICATIONS,NONE,NONE,,NONE,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA, 926380,MD,39.0,F,"About 1 hour after receiving the vaccine she began to feel dizzy, felt like she was going to pass out, racing heart and pupils became constricted.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Dizziness', 'Miosis', 'Palpitations']",UNK,PFIZER\BIONTECH,IM 926381,TX,48.0,F,"On day 7 after receiving the vaccine, a fist sized welt emerged at the injection site. It's 7cm diameter, red and hot. I've been taking Benadryl for 2 days and it has diminished a little but is still there and red/hot.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PVT,"synthroid, progesterone",,,,none,"['Injection site erythema', 'Injection site reaction', 'Injection site warmth', 'Urticaria']",UNK,MODERNA,IM 926382,KY,22.0,M,"Fever, chest pain, cough, headache, chest tightness, shortness of air and fatigue. Symptoms began about 5pm on 1/6/21. Came to the emergency room on 1-7-21. Negative for COVID per PCR test.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,unknown,none,none,,NKA,"['Chest discomfort', 'Chest pain', 'Cough', 'Dyspnoea', 'Fatigue', 'Full blood count', 'Headache', 'Metabolic function test', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 926383,MS,40.0,F,"fast and racing heartbeat, chest pain, dizzy and weak, shortness of breath only lasted 2 days after vaccine was given and then stopped.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"welubutrin, vitamin d, b12",,,,,"['Asthenia', 'Chest pain', 'Dizziness', 'Dyspnoea', 'Heart rate increased', 'Palpitations']",1,MODERNA,IM 926384,MI,21.0,F,"Lightheaded, dizziness, body aches, chills, tachycardia, hypertension, 101.4, swelling and redness around the site, headache, diarrhea. Headache, diarrhea, swelling and redness have not gone away. Went to ER after reaction started, was evaluated in ER. Physician stated it was typical vaccine side effects, no treatment or epi was needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,WRK,Birth control-Jule,None,None,,None,"['Body temperature increased', 'Chills', 'Diarrhoea', 'Dizziness', 'Headache', 'Hypertension', 'Injection site erythema', 'Injection site swelling', 'Pain', 'Tachycardia']",1,MODERNA,IM 926385,FL,57.0,F,"On Jan 6 at 05:30 a.m. while I'm applying lotion on my arms I noticed the redness on my left upper arm, the site is tender, swollen with redness, shoulder pain, itchiness and warm to touch. Today, Jan. 7 I went to my Dr's appointment I was seen by ARNP and she said she will prescribe Lotrisone cream.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,01/06/2021,14.0,PVT,"Aspirin, Vitamin D3, Vitamin E, Vitamin C, Vitamin B-12, B-Complex, Pepcid",None,Narrow angle glaucoma,,No Known Allergies,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 926386,IN,56.0,F,"Severe arm pain starting 4 hrs after injection. Headache. Next morning woke up with severe headache, stomach ache and diarrhea. Generalized fatigue that lasted all day. Woke up 1/7/2021 symptom free.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,Sertraline 100mg Melatonin 10mg,None,None,,NKDA,"['Abdominal pain upper', 'Diarrhoea', 'Fatigue', 'Headache', 'Pain in extremity']",1,MODERNA,IM 926387,GA,55.0,F,Patient tested positive for COVID-19 on 1/4/21.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/04/2021,13.0,PVT,,,,,,"['SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 926388,WI,61.0,F,"Vomiting x 4, Ear Ache, Sore throat, Chills, Myalgia",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,None,None,None,,None,"['Chills', 'Ear pain', 'Myalgia', 'Oropharyngeal pain', 'Vomiting']",1,MODERNA,IM 926389,OH,29.0,F,"CLIENT STATES SHE FEELS LIKE A ""LUMP IN HER THROAT"". DENIES ANY TROUBLE BREATHING OR SWALLOWING. NO EDEMA OF LIPS, FACE OR TONGUE. RESP REG WITH EASE. SKIN PINK, WARM AND DRY. NO NOTED RASH OR HIVES. SYMPTOMS RESOLVED AFTER 10 MIN WITHOUT ANY TREATMENT.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,"ZYRTEC, PEPCID, PRENATAL VITAMINS (NOT PREGNANT OR SEEKING PREGNANCY)",NONE,NONE,,NONE,['Sensation of foreign body'],3,MODERNA,IM 926392,CA,28.0,F,"Symptoms: Headache, Fever, Body Aches, Chills, Nausea, and Vomiting 12/30/2020: Headache started night of vaccination. 12/31/2020: Early next morning experienced chills and nausea. This was followed by vomiting, body aches, and fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,None,None,None,,None,"['Chest X-ray', 'Chills', 'Dehydration', 'Electrocardiogram', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Tachycardia', 'Vomiting']",1,MODERNA,IM 926393,OK,39.0,F,"Patient began experiencing arm redness/swelling approximately the size of 2x2. Reaction started day 3 and increased daily. Patient taking OTC pain reliever and benadryl. States that it feels like a ""bee sting.""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,WRK,,,,,"Penicillin, Sulfa drugs","['Erythema', 'Pain', 'Peripheral swelling']",1,MODERNA,IM 926395,MA,34.0,F,Administration of vaccine completed around 10.00 AM. At 2.00 PM onset of swelling around insertion site. Site warm to the touch and itchy.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,unknown,unknown,unknown,,unknown,"['Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA,IM 926396,NY,36.0,F,"Swollen and painful lymph node in my left axilla. Went to my OB office and they were able to palpitate it and estimate its size at 1cm. They sent me for a mammogram and ultrasound to be sure it wasn't cancerous. Outcome was inflamed node, most likely from vaccine reaction",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PVT,"Lo Loestrin FE Birth control, Levothyroxine 150ug",common cold,"hypothyroid, psoriasis",,none,"['Inflammation', 'Injection site reaction', 'Lymph node pain', 'Lymphadenopathy', 'Mammogram normal', 'Ultrasound breast normal']",1,MODERNA,SYR 926397,IN,51.0,F,"Patient experience severe headache, welts, nausea, extreme fatigue, and reported feeling like walking on broken bones. All over body pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,unknown,unknown,"obesity, diabetes, other",Patient experienced extreme fatigue and severe headache after the initial dose of Pfizer covid vaccine,none,"['Fatigue', 'Gait disturbance', 'Headache', 'Nausea', 'Pain', 'Urticaria']",2,PFIZER\BIONTECH,IM 926398,WI,43.0,F,"Received Moderna COVID vaccine on 1/6/21. On 1/7/21 stated that her right upper arm was red, swollen and warm to touch from injection site into axilla.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 926399,ME,47.0,F,"arm soreness on the day following the vaccine, that lasted for two days. supraclavicular lymphadenopathy that started four days after vaccine. CT done to rule out other lymphadenopathy, none seen, no other sx, so lymphadenopathy thought related to vaccine. the lymphadenopathy has been present for 12 days now and is just starting to go down now.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,WRK,mirena IUD in place,none,none,,clindamycin,"['Computerised tomogram abdomen', 'Computerised tomogram thorax', 'Lymphadenopathy', 'Pain in extremity', 'Vaccination complication']",1,MODERNA,IM 926400,OK,37.0,F,"HEADACHE, BODY ACHES, LEFT ARM SORE AT INJECTION SITE, DIZZINESS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,SEN,TYLENOL,NONE,DIABETES,,NKDA,"['Dizziness', 'Headache', 'Injection site pain', 'Pain']",1,PFIZER\BIONTECH,IM 926401,AR,45.0,F,"I had some aches and pains. I was tired the next morning. I started having chills and became dizzy. My hands started to tingle and remained that way for three days. I developed a cough, sore throat, and fever. The fatigue was really bad for a few days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/22/2020,1.0,WRK,"fluid pill, potassium.",,,3 years ago after my flu shot I got the flu.,,"['Blood test', 'Cardiac monitoring', 'Chills', 'Cough', 'Dizziness postural', 'Fatigue', 'Oropharyngeal pain', 'Pain', 'Paraesthesia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 926402,,32.0,F,"Arm/back pain, chills, fever, lethargy, joint pain for 36 hours - unable to work one day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Arthralgia', 'Back pain', 'Chills', 'Impaired work ability', 'Lethargy', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 926403,WA,26.0,F,"Initial reaction (within 5 min) was minor chest tightening and at the 15 min mark I started to get hives, I let the nurses know of my reaction and they provided me with Benadryl, I then stayed for about an hour after. It has now been about a week, hives still present and starting to present as a rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,PVT,Benadryl,none,Unknown allergies,,Peaches - Had one anaphylactic episode,"['Chest discomfort', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 926404,WA,72.0,M,"About 30 minutes after the administration of the vaccine, his case manager came to ask for assistance because the client was feeling unsteady and his speech seemed slower than it normally is. She was worried about an allergic reaction. He did seem a little shaky. They had him sit on a bench outside for fresh air. He said this was helping. I took his radial HR. It was regular, 70 bpm. I was unable to get his blood pressure due to a broken cuff. He was feeling much better at that point. He did eat breakfast. He said his arm felt fine. No rash or hives observed and no shortness of breath. His case worker brought him some water. We sat there for about 15 minutes. He felt much better and the case worker said he seemed back to 'normal'.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,"docusate 250mg twice daily, clozapine 100mg at bedtime, desvenlafaxine ER 150mg am, Viibryd 30mg daily, simvastatin 40mg at bedtime, melatonin 3mg at bedtime, meloxicam 15mg daily, lisinopril 10mg daily, benztropine 0.5mg hs, aripiprazole 2",None that the pharmacy is aware of.,"schizophrenia, osteoarthritis, constipation, benign prostatic hypertrophy, hypertension",,molindone,"['Anxiety', 'Gait disturbance', 'Speech disorder', 'Tremor']",UNK,MODERNA,IM 926405,MO,46.0,F,"""I don't know if this is related to the vaccine from this morning or not, but I started having a HA around 8:30 am or so. No other symptoms."" ""I do get HAs, but typically it is behind my left eye. I would rate it a 3-4 at this time and I have not had a chance to take any ibuprofen for it, but I will. It started about 8:30 and has continued and gradually worsened.""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,UNK,,,,,,['Headache'],1,MODERNA,IM 926406,GA,50.0,M,Numb upper lip. Lasted 12 hours. Bendryl may have helped.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Lezoceterizin, Singulair, Breo, Flonase, vitamin supplement, vitamin d3, calcium",None,Allergies/Asthma,,NKDA or food,['Hypoaesthesia oral'],1,PFIZER\BIONTECH,IM 926407,IL,33.0,F,"Pt experiences red, hot, swollen and raise bump at the site of injection. The size of the redness has increased over couple days.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/05/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 926408,WI,55.0,M,1/6/21 received Moderna COVID vaccine. Stated that later in the evening had burning in chest and extreme fatigue. 1/7/21 still feeling fatigued and flu like symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Chest pain', 'Fatigue', 'Influenza like illness']",1,MODERNA,IM 926409,MD,45.0,F,"Soon after the vaccination she began having arm pain that lasted for 3 days. That has resolved, but now she is having nerve pain in her right thumb.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,,,,,,"['Axillary pain', 'Immediate post-injection reaction', 'Neuralgia', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 926410,NE,50.0,F,"achy muscles, joint pain, fatigue, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,high blood pressure meds Tylenol Ibuprofen,no,no,,no,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH,IM 926411,TX,44.0,F,"EE reports symptoms fever of 102.0 not going down with Ibuprofen, joint and muscle pain, congestion and cough. Treatment include Ibuprofen with no improvement. Referred for COVID testing.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Arthralgia', 'Cough', 'Myalgia', 'Nasal congestion', 'Pyrexia']",2,PFIZER\BIONTECH,IM 926412,OH,67.0,F,"Moderna COVID-19 Vaccine EUA Generalized body aches especially back, ribs, and sternum, chills lasting throughout the night, but all dissipated within 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,"Losartan, Metoprolol, Amlodipine, Synthroid, Atorvastatin, Leflunomide, Leucovorin, Methotrexate, Remicade, Plaquenil, Magnesium, Zinc, Turmeric, Biotin, Ativan, Multivitamin, Calcium, Flexeril",,RA Chronic back issues Hypertension Asthma Hypothyroid PVCs,,Daypro Neomycin Ophth. Ointment Tincture of Benzoin,"['Chills', 'Pain']",1,MODERNA,IM 926413,IN,28.0,F,"The spot of injection is red, painful, and swollen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,"Cal/mag/zinc, vitamin D, shatavari, ashwagandha, brahmi",None,None,,NKA,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,SYR 926414,WI,31.0,F,Left axillary swelling developed on day 2 after vaccination. Measuring approximately 6 cm x 6 cm. Site is visibly mildly swollen. Feels firm. Tender to palpation.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,WRK,"Duloxetine 60 mg, loratadine 10 mg",None,None,,None,"['Injection site induration', 'Injection site pain', 'Injection site swelling', 'Oedema peripheral']",2,PFIZER\BIONTECH,IM 926415,NY,45.0,M,"Headache, chills, shortness of breath, fever, body aches from shoulders to feet, fatigue, slight confusion. Honestly, I feel worse now when compared to when I actually had covid. Took Tylenol. When Tylenol wears off symptoms come back.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,OTH,None,Covid 12/2/2020 - 12/14/2020,None,,Sulfa,"['Chills', 'Confusional state', 'Dyspnoea', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 926416,WI,63.0,F,"Patient reported onset of chills, aches, fatigue, nausea, dizziness within 24 hours of receiving 1st dose of Moderna COVID-19 vaccine. Post COVID-19 infection onset 12/24/2020. Had been released back to work and sx free 01-04-2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Chills', 'Dizziness', 'Fatigue', 'Nausea', 'Pain']",1,MODERNA,IM 926417,CA,48.0,F,"Tingling of the lips, strange taste of ink, increase BP systolic at 190 diastolic at 105, Heartrate 110-120. On site physician at bedside in recovery area. Emergency services requested due to unresolved symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,Unknown,30 days within testing positive for COVID-19,Diabetes,,Unkown,"['Blood pressure increased', 'Paraesthesia oral', 'Taste disorder']",1,MODERNA,IM 926418,IA,29.0,M,"Client went to bed Tuesday evening feeling more tired and temperature of 99.4. Woke up Wednesday feeling worse with body aches, shaking, fever of 100.2 and headache. Took Tylenol throughout the day and had a loss of appetite but woke up Thursday morning feeling better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,None,None,Leaky Heart valve- born with,,Penicillin,"['Body temperature increased', 'Decreased appetite', 'Fatigue', 'Headache', 'Malaise', 'Pain', 'Tremor']",1,MODERNA,IM 926419,GA,37.0,M,1 WEEK POST VACCINATION WITH NEW ONSET LOSS OF TASTE. COVID PCR TESTS X2 ARE NEGATIVE.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,SYMBICORT SINGULAIR ZYRTEC BENADRYL,NO,ASTHMA,,NO,"['Ageusia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 926421,IN,46.0,F,Shingles outbreak 5-7 days after infection in C6-C7 dermatome of left arm (injection was in right arm) limiting the use of this arm and causing excruciating pain and discomfort.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/29/2020,7.0,PVT,Sertraline 100mg qd,None,Obesity (BMI 30),,NKDA,"['Discomfort', 'Herpes zoster', 'Mobility decreased', 'Pain']",1,PFIZER\BIONTECH,IM 926422,IN,43.0,F,"Low grade fever (99.9 - 100.6), flu-like symptoms - severe headache, body aches, muscle pain and weakness. Onset of all symptoms began 24 hour after vaccine administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,WRK,"Ibuprofen, Tylenol, Philips Colon Health Probiotic, Omega 3",None,"Psoriasis, psoriatic arthritis, hypertension",,None,"['Asthenia', 'Headache', 'Influenza like illness', 'Myalgia', 'Pain', 'Pyrexia']",1,MODERNA,IM 926423,KS,66.0,M,"Extreme chilling, no fever, weak, achy all over. Lasted 8 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,unknown,none,Covid - 19 - 11/2020 Coronary Heart Bipass - 5/2020,,No known allergies,"['Asthenia', 'Chills', 'Pain']",1,MODERNA,IM 926424,ND,27.0,F,"Presented to Urgent Care 01/05/2021 Pt. States swelling started the night prior. Provider describes it as left upper arm finds a patch about the size of a silver dollar which is red, warm, + tender with some indentation in the center. No red streaking up the arm, shoulder",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,PVT,Albuterol Sulfate Ativan Azelastine - fluticasone betamethasone Valerate Clindamycin Phosphate Elidel Epi-Pen Ketoconazole minocycline Sertraline Symbicort Triamcinolane acetate,Anxiety Depression Hypoglycemia Mild intermittent asthma Perennial Allergic rhinitis,Asthma Rhinitis Anxiety Depression Hypoglycemia,,NKDA,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Ultrasound scan']",1,MODERNA,IM 926425,CO,75.0,F,"Initially with erythema and arm soreness that resolved within 1-2 days. On day 6 after injection, she developed significant itching and recurrence of erythema at vaccine site. She was treated for cellulitis with antibiotics and topical steroids for itching. She has long history of skin sensitivity and rash with previous vaccines.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/05/2021,6.0,PVT,,,,Rash with pneumococcal vaccine in 2009,,"['Cellulitis', 'Erythema', 'Injection site pruritus', 'Pain in extremity', 'Vaccination site erythema']",1,MODERNA,IM 926426,CA,43.0,F,"Developed a hard knot almost a week later it feels warm, itchy, and a little tender.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/03/2021,6.0,WRK,"Dexilant, Amlodipine, Famotidine",NONE,NONE,,NONE,"['Nodule', 'Pruritus', 'Skin warm', 'Tenderness']",1,MODERNA,IM 926427,MI,46.0,F,"01/06/2021 r eyelid swollen, face and upper lip; provider gave epi -- reduced some swelling. L wrist swelling today 1/07/2020 sinus tachycardia 140-150.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,eye wash (no name given),,"Diabetes, Hypotension, elevated Lipids",,,"['Electrocardiogram abnormal', 'Joint swelling', 'Lip swelling', 'Sinus tachycardia', 'Swelling face', 'Swelling of eyelid', 'Tachycardia']",1,PFIZER\BIONTECH, 926428,CA,28.0,F,"12/30/2020: Symptoms began with a headache 12/31/2020: Woke up early morning with chills and nausea. Symptoms followed with a fever, vomiting, and body aches. I went to the emergency room and was told I had tachycardia and dehydration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,None,None,None,,None,"['Chest X-ray', 'Chills', 'Dehydration', 'Electrocardiogram', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Tachycardia', 'Vomiting']",1,MODERNA,IM 926429,PA,45.0,F,"Patient called, stating swelling of arm and lymph nodes within 24 hrs of injection and lump at site. Applied ice and heat. States it is getting better but if ""ball"" does not get any better would like to be seen. Agreed with aptient",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Injection site mass', 'Lymphadenopathy', 'Peripheral swelling']",UNK,PFIZER\BIONTECH, 926430,WA,33.0,F,"swelling of eyes 10 minutes post vaccination, then tongue swelling and tingling lips. no shortness of breath, Given IM diphenhydramine. Some improvement of swelling 20 minutes after diphenhydramine, swelling of tongue and lips totally resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,,,,,"shellfish, mango, peanuts","['Eye swelling', 'Paraesthesia oral', 'Swollen tongue']",1,MODERNA,IM 926431,SC,84.0,M,Loss of taste and smell for past 4 days,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,PVT,"Celcoxib 200 mg, Citalopram 10 mg, Loratadine 10 mg, Losartan 100 mg, Metformin 1000 mg, Omeprazole 20 mg, Pravastatin 20 mg, Propranolol 120 mg",Beginning bronchitis,Annual bronchitis,,None,"['Ageusia', 'Anosmia']",1,MODERNA,IM 926432,NY,,F,"Itchiness, rash",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/06/2021,14.0,UNK,"Oral Contraception, Vyvance, Prozac",,,,Latex,"['Pruritus', 'Rash']",1,MODERNA,IM 926433,FL,88.0,F,Hemmoragic Stroke. Began with vision difficulty in the morning. Then I noticed she had left sided neglect. Went to ER. Treated with Andresxa (to counteract Elaquis). In SICU for 2 nights then telemetry unit for 3 nights. CUrrently in Rehab.,Not Reported,,Not Reported,Yes,5.0,Yes,N,12/28/2020,12/31/2020,3.0,PVT,"Elequis, Amiodoron, pravastatin, losartin, synthroid, timalol","high bp, high cholesterol,","deaf in rt ear - rt vestibular schwanoma,",,none,"['Computerised tomogram abnormal', 'Haemorrhagic stroke', 'Intensive care', 'Neurologic neglect syndrome', 'Visual impairment']",1,MODERNA,IM 926434,ME,57.0,F,"After being given the vaccine the patient was asked to wait 15 minutes before returning to work. After 5-10 minutes she reported shortness of breath and an anaphylactic type reaction. Patient was administered an Epi-pen by a nurse and the facility, and reported feeling ""a little better."" She was also given oxygen and put on a pulse oximeter. Her O2 sat was 99% throughout. She reported before that she had no allergies and no adverse reaction to a vaccine in the past, but after this happened she said something similar also happened in the past with a flu shot. Patient believes this reaction was due to anxiety and not an allergy. 911 was called and arrived about 15-20 minutes after administration and patient was taken to the hospital. A nurse called the hospital 2 to 3 hours later and they reported she was ""doing fine"" and would be discharged home later today.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,SEN,"UNKNOWN, NONE REPORTED",NONE REPORTED,NONE REPORTED,SIMILAR EVENT DESCRIBED DUE TO A FLU SHOT PER PATIENT. OTHER INFORMATION UNKNOWN.,NONE REPORTED,"['Anaphylactoid reaction', 'Anxiety', 'Dyspnoea']",1,PFIZER\BIONTECH,IM 926435,IN,28.0,M,"I had diarrhea in the morning and then my symptoms progressed to include chills, body aches, lightheadedness, and fatigue. The injection site was also very painful. When I woke up this morning, I didn?t have any symptoms other than a little bit of fatigue and slight soreness in the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Injection site pain', 'Pain']",1,MODERNA,SYR 926436,TX,72.0,M,"Besides just having a sore arm at point of injection, I have had a pox come up on my right forearm. I did have my first shingles shot on November 18th, 2020 at the clinic here. I think it is a single pox and thought I would bring it to your attention. I have had the shingles before so I know what they look like and feel like. Since there is only one, I don't plan on going to my dermatologist to confirm that it is a pox plus I am not sure if the Covid shot is a side effect that caused the pox or not. It is not painful although itching and not responding much to antiseptic cream. I plan to go for my second Covid shot on January 26 and I am looking forward to it. I don't go for my second Shingles shot until February 17. There is a possibility that it could be something else besides a pox but wanted to bring it to your attention just in case. Thanks.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,"Omeprazol, Simvastatin, Levothyricin",None,None,,None,"['Injection site pain', 'Pruritus', 'Pustule']",UNK,PFIZER\BIONTECH, 926437,NE,40.0,F,"1/5/2021 - Day 1: R) deltoid pain at injection site around 1600, mild headache viewing around 2100 when going to bed. I took ibuprofen prophylactically to prevent pain getting worse. 1/6/2021- Day 2 around 00:00, I was woken up out of bed with severe body aches all over. Mostly to bilateral hip joints and lower. Arm pain and headache were barely noticeable d/t other pain. Pain radiated to arms down to both shins. It hurt to touch skin and took ibuprofen around 0130-0200. It was so bad I couldn't roll my body up without assistance and I'd need to use restroom for almost 2 hours at this point. Had to call out of work because I knew this pain wouldn't go away in a few hours in addition to lack of sleep, I knew it'd be better to rest with OTC, rest, And heating pad. Later this day I was still feeling the same, went to store to get something for body aches. It wasn't until I was in this store, when my left femur bone hurt so bad I had to grab onto a shelf. I felt my bone was about to break - scary. (My1 st time experience the bone pain symptom) Later at home same day, spent an hour going back and forth to bathroom with large loose/water diarrhea. I slept most of the day, as I was too fatigued to do simple tasks. Went to bed around 21:00 after taking ibuprofen, laying on heated and covered in electric blanket. 1/7/2020 woke up at 05:50 to get ready for work and instantly felt the pain again and headache, I'm usually not so tired after sleeping, so contributed that to same fatigue. Although is not pounding, still dull. 1/7/2021 0900 took my HCTZ, Propranolol, and Potassium. Today the pain is not as high, but better than yesterday. I expect to feel a lot better tomorrow to go into work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,None,None,"idopathic uritcaria elevated blood pressure at times, but no consistent high",,"Sulfa, levaquin","['Arthralgia', 'Bone pain', 'Diarrhoea', 'Fatigue', 'Fear', 'Headache', 'Impaired work ability', 'Injection site pain', 'Insomnia', 'Mobility decreased', 'Pain', 'Pain in extremity', 'Pain of skin']",1,MODERNA,IM 926439,MN,30.0,F,"Injection site swelling, redness, itchiness lasting more than 1 week. Swelling and redness is splotchy and 1-2 inches surrounding injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,SEN,Fluoxetine Spironolactone Viviscal B12 Vitamin,None,Obesity,,Ibuprofen-hives,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Rash macular']",1,MODERNA,IM 926440,NY,54.0,M,"Cold sweats, fever of 100, pain the my joints",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,None,None,Asthma,,Amoxicillin,"['Arthralgia', 'Cold sweat', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 926441,WI,30.0,F,I received my vaccination at my place of work. Local pharmacy came in to administer them. In less then a minute of recieving the vaccination I experienced a tightness in my chest and difficulty breathing. I told my symptoms to the pharmacist that was there. I had to take my mask off due to the difficulty breathing. I sat down and was trying to catch my breath. Roughly 10 -15 minutes passes then my throat began to swell. My extremities were feeling tingly and I was very dizzy. I sat with my neck extended to maintain my airway until they could locate some benedryl. My voice was wheezy when attempting to answer questions the pharmacist was asking. The pharmacist wanted to administer the EpiPen but I would not allow her to because then they would have to call 911. It took about 45 minutes in total to locate benedryl. I took 50 mg. Roughly 15 -20 minutes after taking the benedryl I was able to breath with ease. I waited about another 15 minutes at the facility to ensure I was ok. I was told I would not be recieving the second dose due to my anaphylactic reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,None,None,None,,"Avocado, broccoli","['Chest discomfort', 'Dizziness', 'Dyspnoea', 'Paraesthesia', 'Pharyngeal swelling', 'Wheezing']",1,MODERNA,IM 926442,CO,32.0,F,Fever 101.2 and body aches the day after receiving vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/17/2020,1.0,PVT,,,,,,"['Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 926443,MO,25.0,F,Patient received Pfizer COVID vaccine intramuscularly in the right arm. Patient reported initially she has a shellfish allergy. Patient was being monitored in designated location when the patient reported her tongue was becoming numb and experiencing dizziness. Onset of symptoms was about 7 minutes after her shot. The patient denies difficulty breathing . Patient was sent to the emergency room where labs were drawn with no critical results. Patient was discharge on a medrol dose pack and discharged from the ED after feeling better.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Aspirin Fondaparinux Methylprednisolone Prenatal,,-Frequent UTI's in child hood -DNCX X1,,1)fish -Shell fish allergy- Reaction listed: Anaphylaxis 2)heparin 3)iodine,"['Dizziness', 'Hypoaesthesia oral']",1,PFIZER\BIONTECH,IM 926444,NC,64.0,F,"Flu-like illness (fevers, rigors, chills) and one episode of presyncope due to orthostatic hypotension upon getting up the day after the vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"calcium citrate, nexium, hctz",none,hypertension,,"losartan, prilosec","['Chills', 'Electrocardiogram', 'Influenza like illness', 'Orthostatic hypotension', 'Presyncope', 'Pyrexia']",1,PFIZER\BIONTECH, 926445,TX,34.0,F,"Headache, chills and significant body aches (back, neck, arms, legs) starting about 4 hours after administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Daily women's vitamin Biotin supplement,None,Asthma Migraines,,None,"['Chills', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 926446,OH,56.0,F,Red welted area at site of injection. Hot and risen about 2x2inches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Warfarin,,Factor V deficiency,,"Sulfates, bandaids","['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Urticaria']",UNK,MODERNA, 926447,MD,56.0,M,"Starting on 1/4/21 he began having a severe headache, extreme fatigue, vertigo and lower back pain. The symptoms lasted about 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/04/2021,4.0,PVT,,,,,,"['Back pain', 'Fatigue', 'Headache', 'Vertigo']",1,PFIZER\BIONTECH,IM 926448,CA,45.0,F,"During the vaccination step of injection, a leak was noted. Since there was vaccine liquid outside of the syringe, it was likely that less than the drawn up 0.5 ml was given to the patient. Patient was notified of incomplete dose and told that she would need to be revaccinated. She verbalized understanding and was re-vaccinated with correct dose. Patient had no signs or symptoms of any adverse reaction during the 15 min post vaccination holding period.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PUB,unknown,unknown,unknown,,unknown,"['Immunisation', 'No adverse event', 'Syringe issue', 'Underdose']",1,MODERNA,IM 926449,NC,23.0,M,"Patient described dizziness, decreased heart rate (67 bpm). Thought may be anxiety driven but had patient put feet up and wait an additional 15 minutes. Lasted less than 30 minutes, patient stated fine and left clinic shortly after 30 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,not available,not available,Anxiety,,not available,"['Dizziness', 'Heart rate decreased']",1,MODERNA,IM 926451,CA,41.0,M,Sore swollen throat Fatigue Sore arm,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Fatigue', 'Oropharyngeal pain', 'Pain in extremity', 'Pharyngeal swelling']",1,MODERNA,SYR 926452,MO,64.0,F,"At twelve hours post injection I awoke with severe chills even though I did not have a temperature. After taking 1000 mg of Tylenol the chills past in approximately an hour. The rest of the day I had extreme fatigue, headache, lethargy, and loss of appetite. By the next morning I still had the fatigue and weakness which improved gradually over the next 12 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,PVT,"Toprol 100 mg daily, Protonix in AM, Norvasc 5 mg. daily, Loratidine 10 mg at hs, Myrbetriq 25 mg. at hs, Calcium with Vit D 600 mg at HS, Cranberry",no,Mitral Valve Prolapse,,no,"['Asthenia', 'Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Lethargy']",UNK,PFIZER\BIONTECH,IM 926453,GA,40.0,F,"1 WEEK POST-VACCINATION, WARM, RAISED, RED ITCHY 4X4CM AT INJECTION SITE",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,CARDIZEM JANUNET BIRTH CONTROL TRINTELIX ADDERALL,NO,DIABETES ASTHMA POTTS,,NO,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 926454,FL,62.0,F,"Following vaccination the patient had progressively worsening abdominal pain over the next 24 hours. Presented to the ER and was initially thought to have appendicitis. However, it was then discovered during surgery that the appendix was surgically absent. The surgeon did not that the patient did have a ""Round, infarcted ligamentous tissue was wrapped around ascending colon. """,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,,,Hyperlipidemia DJD,,"Avelox, Dilaudid, Percocet, Pylera","['Abdominal adhesions', 'Abdominal pain', 'Surgery']",1,MODERNA,IM 926455,,42.0,F,"1300 vaccine received 1310 pt reported feeling dizzy. VS 97.6, BP 134/83, HR 68 O2 99% room air. 1315- persistent dizziness, first responder called and patient transferred to bed. 1318: VS O2 100% room air, HR 85, BP 165/89, temp 97.1 1319: First responder team arrived. Patient denied needing to be seen in the ED. 1320-1330 patient continued to lay supine. At 1330, patient was able to sit and dangle with no dizziness. Shortly after, patient ambulated and felt fine. Patient discharged from clinic and told to report to Employee Health or ED if symptoms return, or new symptoms occur.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,,,,,,['Dizziness'],1,MODERNA,IM 926456,MO,30.0,F,"Started having severe chills on saturday Jan 2, 2021 resolved with acetaminophen and rest. The next day it kept coming back and more symptoms became present. Symptoms: chills, fever (100.7F), diarrhea, shortness of breath, cough, fatigue, muscle and body aches all over and loss of appetite. OTC meds have helped, but does not resolve. Still unable to get out of bed or function due to severity of cough and shortness of breath as of today Thursday Jan 7th, 2021. This has been going on for 6 days now.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,WRK,acetaminophen,None,None,Flu Vaccine,None,"['Chills', 'Cough', 'Decreased appetite', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Myalgia', 'Pain', 'Pyrexia', 'SARS-CoV-2 antibody test negative', 'SARS-CoV-2 test negative']",1,MODERNA,IM 926457,VA,32.0,F,"L arm muscle achiness, mild fatigue, mild headache- completely resolved 36 hrs after administration. No treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,WRK,Prenatal vitamins,None,Breastfeeding,,Pommelo,"['Fatigue', 'Headache', 'Myalgia']",1,PFIZER\BIONTECH,IM 926458,PA,45.0,F,patient called stating she had swelling of arm with lymph nodes.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Lymphadenopathy', 'Peripheral swelling']",1,PFIZER\BIONTECH,IM 926459,,34.0,F,"Arm pain, induration, and erythema at injection site 1 inch appeared 8 days after vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/27/2020,01/04/2021,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pain']",1,MODERNA,IM 926460,KY,74.0,F,"had COVID in October and got doses of plasma. started about midnight after the vaccine: Fever 101.9, shaking, O2 sast 80s, hr 120, arms and leg joint ached terribly, headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,prednisone 2.5mg,,"Gaint Cell Arthritis, PMR",,"allergy to nickel, codeine, ultram, all pain medicines, tylenol","['Arthralgia', 'Headache', 'Pyrexia', 'Tremor']",1,MODERNA,SC 926461,AR,44.0,F,"Pfizer BioNTech COVID 19 vaccine EUA- Chills, nausea, muscle aches, headache. Motrin 400 mg taken Q4-6 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,"Zoloft, Metoprolol",none,none,,none,"['Chills', 'Headache', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,IM 926462,,91.0,M,Patient developed hypoxia on 1/4/2021 and did not respond to maximal treatment and passed way on 1/5/2021,Yes,01/05/2021,Not Reported,Yes,,Not Reported,,12/28/2020,01/04/2021,7.0,UNK,"Lorazepam, pantoprazole, miralax, senna plus, carbodopa-levodopa, metoprolol, mirtazipine, quetiapine","dementia, Upper gastrointestinal bleed","Advanced dementia, Parkinson's' disease ,chronic kidney disease, sciatica, hyperlipidemia",,no known food or medication allergies,"['Absence of immediate treatment response', 'Death', 'Hypoxia']",1,PFIZER\BIONTECH,IM 926463,WA,42.0,F,"Tingling/numbness in neck, throat and roof of the mouth. Heart Palpitations",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,none,,,none,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Palpitations', 'Paraesthesia oral', 'Pharyngeal hypoaesthesia', 'Pharyngeal paraesthesia']",1,MODERNA,IM 926464,OK,47.0,F,"7 days post injection, red, itchy lumps appeared at the injection site. Day 8 post injection, diffuse swelling, but no longer multiple lumps. Area measures approximately 2.5x1.5 inches, is uniformly inflamed, uneven circular shaped, and is bright red. Redness has spread slightly since onset likely due to gravity (downward migration is slight). Day 2 experienced extreme fatigue, no other symptoms Day 3 sore at the injection site, no other symptoms Day 4 sore at the injection site, no other symptoms Days 5-7 no symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,OTH,none,None.,None.,,"Keflex, theophylline, sulfa drugs.","['Erythema', 'Fatigue', 'Inflammation', 'Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site pruritus', 'Swelling']",1,MODERNA,IM 926465,AL,41.0,F,"24 hours post-vax woke with severe dizziness severe, fatigue, and muscle aches. Fever from 12/21 -12/22 21, peak temp 102.9. However, I am breastfeeding and suspect I may have had mastitus. Took measures to hydrate and express milk to ensure that was treated. Spoke to NP in the ER unit, did not take prescribed meds since fever broke.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/20/2020,1.0,WRK,Post natal vitamins,No,No,,"Sulfa, ceclor","['Breast feeding', 'Dizziness', 'Fatigue', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 926466,RI,55.0,F,Patient reported rapid and immediate fatigue post vaccination and nose bleed. Patient oxygen saturation rate remained over 95% during 3 hours of monitoring post injection. One hour post injection patient noted right sided frontal headache that did increase in severity. Patient BP increase to 151/88 and was 130/80 at discharge,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,"fluoxetine, trazadone, ibuprofen, vitamin",HTN,"HTN, anxiety",,Losartan,"['Epistaxis', 'Fatigue', 'Headache', 'Immediate post-injection reaction']",1,MODERNA,IM 926467,WV,64.0,F,"left deltoid swollen, red and painful. No bruising",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PHM,,,,,none,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 926468,OH,42.0,F,"Night of vaccination approx. 4 hours after began feeling flushed, dizziness, arm soreness, severe body aches, nausea. Continued through night worsening on/off with chills. Had episode for 4 hours where had numbness in hands bilat. Still feels fatigue, achiness today. Attempted to work today but kept getting flushed and dizzy so was sent home.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Lodine, Zyrtec",No,Neurocardiogenic syncope- rarely has issues with any more,Flu vaccinations has had reactions if has preservatives,"Rubber, multiple antibiotics, preservatives","['Chills', 'Dizziness', 'Fatigue', 'Flushing', 'Hypoaesthesia', 'Impaired work ability', 'Nausea', 'Pain', 'Pain in extremity']",1,MODERNA,IM 926469,OK,47.0,F,"approximately 30 minutes after administration of vaccine, patient experienced tingling throat, cough and self-reported flushing. She was given Benadryl 50mg",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,unknown,unknown,unknown,,iodine contract,"['Cough', 'Flushing', 'Pharyngeal paraesthesia']",1,MODERNA,IM 926470,CA,28.0,F,"Pt c/o shortness of breath 2.5 hours after vaccine. Also reports hives, headache, dizziness and nausea since last night.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,,,ASTHMA,,REGLAN,"['Blood test', 'Dizziness', 'Dyspnoea', 'Full blood count', 'Headache', 'Nausea', 'SARS-CoV-2 test', 'Troponin', 'Urticaria']",1,PFIZER\BIONTECH,IM 926471,AL,39.0,F,"Right eye itching, swelling, watering",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Lisinopril, ozempic, atorvastatin, celexa, ibuprofen",,"High blood pressure, high cholesterol, type 2 diabetes",,,"['Eye pruritus', 'Eye swelling', 'Lacrimation increased', 'Reaction to preservatives']",1,MODERNA,SYR 926472,PR,48.0,F,"After 10 minutes of vaccine administration patient report metallic taste, she was oriented to stay in the observation area of the vaccine administration site for 10 additional minutes. At 12:00pm patient report throat itching ""like chocking"". Shock anaphylactic code (RR) was activated. At 12:03pm Epinephrine 0.3mg/1ml was administrated to the left thigh. Venous access was obtained and Solu-Cortef 200mg, Benadryl 50mg and O2 were administrated. Patient vital signs were blood glucose 121mg/dl, Oxygen Saturation 100%, BP 150/90 mmHg. Patient was transfer with the RR code team to the ER for observation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Neurontin 300mg Cataflan 50 mg,None,Degenerative disc disease Skin Cancer,,NKA,"['Blood glucose normal', 'Choking sensation', 'Dysgeusia', 'Throat irritation']",1,PFIZER\BIONTECH,IM 926473,SD,30.0,F,"When vaccine was administered, seemed high on my arm. I had immediate soreness and shoulder discomfort, I was told this was normal. It continued to progress and I eventually had decreased ROM, weakness and sharp shooting pain in my shoulder. Working at OI, I consulted provider, xrays were obtained and I was evaluated. He strongly suggested an MRI be obtained as well. That was completed the same day as my evaluation on 12/31/2020 (1 week and 2 days after the vaccine was administered). The provider informed me that they have had patients with similar situations that were evaluated for frozen shoulder after having a vaccine d/t administration site and vaccine going into subacromial space. He does report that this was my case/situation, upon my exam, I had severe inflammation with this as well-he is now having me follow up for a surgical consultation for my shoulder to be repaired. Today's date is 1/7/2021, I have these same ongoing symptoms that have continued since day of administration, without diminishing in severity. He is unable to provide an injection d/t my upcoming second dose of the COVID vaccine this next week, 1/12/2021. He strongly suggests that my 2nd vaccine be administered elsewhere-advised NOT be administered in the same shoulder OR in opposite to cause these symptoms to flare. He advised in gluteus if possible to avoid any further issues if at all possible.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/22/2020,12/22/2020,0.0,OTH,"Novolog, Trokendi, Metoprolol, Biotin, Vitamin D, Vitamin C, Potassium",,Type 1 Diabetic POTS Migraines,,Morphine Tomatoes,"['Arthralgia', 'Immediate post-injection reaction', 'Inflammation', 'Joint range of motion decreased', 'Magnetic resonance imaging joint', 'Muscular weakness', 'Musculoskeletal discomfort', 'Pain', 'X-ray limb']",1,PFIZER\BIONTECH,IM 926474,MN,25.0,F,"Hives over entire body started Sunday night (01/03/2021). No change in hives, worsening with heat and at night. Was seen in urgent care (on 01/05/2021) and given a topical cream (Triamcinolone Acetonide) that did nothing. Seen by dermatologist (1/07/2021) and given IM steroid injection and a methylprednisone pack for 6 days. Symptoms improved with IM injection. But still in the process of completing the steroid pack.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,PVT,Junel Birth Control Vitamin B12,,,,,['Urticaria'],1,PFIZER\BIONTECH,IM 926475,AZ,21.0,M,"RASH AT SITE, SHORTNESS OF BREATH, DIZZINESS, INCREASED HEARTRATE, T-101, CHILLS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,NONE,NO COVID POSITIVE ON 12/7/2020,,,NONE THAT IS AWARE OF,"['Body temperature increased', 'Chest X-ray', 'Chills', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Heart rate increased', 'Injection site rash']",1,MODERNA,IM 926476,ME,43.0,F,Mild headache and eye floaters in left eye only,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Biotin, multi-vitamin, Veranique",,,,,"['Headache', 'Vitreous floaters']",1,MODERNA,IM 926477,,42.0,F,"Delayed (7 days) injection site swelling, induration, heat.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/27/2020,01/03/2021,7.0,PVT,,,,,,"['Injection site induration', 'Injection site swelling', 'Injection site warmth', 'Skin reaction']",1,MODERNA,IM 926478,NY,59.0,M,"Sore arm, tingling in hand and fingers. severe nausea and head ache. fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,none,none,none,,sensitive to ASA,"['Fatigue', 'Headache', 'Nausea', 'Pain in extremity', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 926479,OK,31.0,F,"Day 1: nausea, severe stomach cramps, pain in the injection site Day 2: fatigue, tiredness, headache, chills Day 3: fatigue, raised area, itching in the arm, pain in arm Day 4: nausea, diarrhea, itching in arm, raised bump at injection site, itchy throat, cough, runny nose",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Humara injection two times/month, Advair discus, Allegra",,"rheumatoid arthritis, hashimoto's disease, Irritable bowel syndrome",,,"['Abdominal pain upper', 'Chills', 'Cough', 'Diarrhoea', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Nausea', 'Pain in extremity', 'Pruritus', 'Rhinorrhoea', 'Swelling', 'Throat irritation']",1,PFIZER\BIONTECH,SYR 926480,MO,53.0,F,"Approximately 2 hours after the vaccine she reported a ""spot on her arm"" where the vaccine had been given, a headache and back ache. She did go to the chiropractor on 1/4, but states it did not help. She saw an allergy specialist on 1/5. As of 1/7/20 0830am she still had a headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Back pain', 'Headache', 'Injection site reaction']",1,PFIZER\BIONTECH,IM 926481,IA,23.0,F,"On day 1 (day I was vaccinated) I experienced severe pain in my arm where I was injected with the vaccine 3 hours after receiving it. I couldn't use my arm for the rest of the day and had to take Tylenol to help with swelling and pain. Pain was dull and throbbing. The next morning I woke up to body chills, a low grade fever, muscle aches, vomiting, exhaustion/fatigue, coughing, and diarrhea. The injection site was still very tender, sore, and swollen with limited mobility. All symptoms subsided within two days other than fatigue and a sore arm. On day 3 I developed a cough that lasted 4-5 days. Other than a cough, I had no other symptoms after that. My arm was better with no pain and easy to use. Then on day 8 my arm started to swell again and I developed a distinct rash at the injection site. The skin around the area was hot to touch and very hard and tender. I took ibuprofen and rubbed out the arm to help. I contacted my provider and she examined the arm, concerned I was having a reaction and possibly developing cellulitis. On day 9 the rash spread to the whole upper arm and shoulder were hot to touch/feverish, painful, hard, and still swollen. The swelling has continued to move up my arm. I am seeking medical attention today on 1/7/21 for treatment of possible cellulitis.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,"Armour thyroid, Phentermine, Vitamin ADK, Vitamin B12, Protandim NRF2 supplement, Probiotics, Berberine supplement, & Adrenal complex supplement.",Unknown,Hypothyroidism,,"Gluten, Bees/Wasps, Latex, & Sulfa drugs.","['Chills', 'Cough', 'Diarrhoea', 'Fatigue', 'Injected limb mobility decreased', 'Injection site induration', 'Injection site pain', 'Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Myalgia', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Vomiting']",2,MODERNA,SYR 926482,NM,27.0,F,bodyaches chills mild tachycardia HR 120s,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Chills', 'Full blood count normal', 'Metabolic function test normal', 'Pain', 'Tachycardia']",UNK,MODERNA,IM 926483,AR,37.0,F,"Pfizer BioNTech COVID 19 vaccine EUA- fever, headache, fatigue. Fever lasted less than 23 hours. no medications still have slight HA",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,none,none,non e,,sulfa drugs,"['Fatigue', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH,IM 926484,AL,58.0,F,"tongue felt numb, denied shortness of breath. Benadryl 25mg given po, no rash, patient left after 20 minute observation after Benadryl given.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,['Hypoaesthesia oral'],2,PFIZER\BIONTECH,IM 926486,TX,61.0,F,"I am itching all over my body. My left hand has swelling in it. It hurts and where it is swollen it is sore. My arm is weak. It is hard to lift my left arm up and put it across my chest because that hurts. It hurts in my lymph nodes and my joints. I had to go the the ER on 12/31/20 because of this. they gave me a shot of Prednisoneand Hydroxyzihe that helped for a coupled of days and then I had to go back to the ER on 1/6/21 because of the same symptoms. They gave me Benadryl,prednisone and pepcid. I am still itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,"Oxcarbazepine,meloxicam,Zelnorm,TemzepamAmlodipine,TrazodoneLevothyroxine","Hypothyroid, biopolar high blood pressure ,stiff joints",bipolar high blood pressure hypothyroid stiff joints,,Sulfa,"['Arthralgia', 'Headache', 'Lymph node pain', 'Mobility decreased', 'Muscular weakness', 'Peripheral swelling', 'Pruritus']",1,MODERNA,IM 926488,TX,31.0,F,"EE reports fever of 100.3, achy, muscle and joint pain, and HA. Treatment with Tylenol with no improvement. She will continue to monitor.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Arthralgia', 'Headache', 'Myalgia', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 926489,MI,79.0,M,Resident was noted yesterday to have red itchy rash to his left arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,SEN,"Senna, Miralax,",None,"Heart failure, hypertensive heart disease with heart failure, diverticulosis of intestine, dementia, Type 2 diabetes mellitus.",,"Nortriptyline, latex, bandaids","['Rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 926490,MD,40.0,F,"Patient received vaccine and completed 15 minute observation without incidence. Patient went home. Patient's mother-in-law (MIL) was working as a MD today. About 2:15pm, the MIL notified a staff RN in the clinic that her daughter-in-law (patient) was c/o of tachycardia. The patient called her PCP who recommended she use her prescribed epi-pen and go to the ED. The MIL told the staff RN that the patient had a history of allergies and carried an epi-pen. The MIL left the clinic at that time and we have not heard any update from her or the patient. In Item 21, I selected ""Emergency Room,"" but do not know for certain if the patient went to the ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,Unknown,Unknown,None listed on screening checklist,,"No severe allergy reaction to vaccine listed on screening checklist. Per mother-in-law (who was volunteering at today's clinic charting), patient has history of allergies and carries an epi-pen. Mother-in-law did not state what patient is allergic to.",['Tachycardia'],1,MODERNA,IM 926491,WI,26.0,F,"Temporal thermometer reading got up to 105 F, brought down to 102.9 with Tylenol(1,000 mg taken) along with tepid bath and pushing cool oral fluids, headache lasting throughout day making sensitivity to light and noise without being dizzy. ibuprofen taking q6 to help with headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"Tylenol, multivitamin, vitamin D, Vitamin C, Synthroid, ibuprofen",,hypothyroidism,,NKDA,"['Body temperature increased', 'Headache', 'Hyperacusis', 'Photophobia']",2,PFIZER\BIONTECH,IM 926492,UT,37.0,F,"31st December 2020: mild tingling down left arm within 10 minutes of injection. Sore arm at vaccine site. 1st January 2021: increasingly sore left arm at site. 2nd - 3rd January 2021: moderately sore arm, mild dry cough and mild neck and head ache. Tiredness. 4th January 2021: moderate headache not completely relieved by pain medication, muscle aches, nerve type pain both sides of neck, fatigue. Took day off work. 5th January 2021: as with 4th January plus some loss of smell and taste, some nausea, occasional sneezing and mild sore throat. Had appointment with doctor; doctor recommended covid test also to double check. Day off work. 6th January 2021: had covid test morning. Ongoing symptoms same. Easing headache now though, more stomach irritability with eating, cannot taste or smell completely now. Needed another day off work. 7th January 2021: Awaiting covid test results, cannot work due to this and also still unwell. Ongoing symptoms including muscle aches, neck ache and feeling of nerve pain left more than right side of neck. Improved stomach, not as irritable. Another day required off work.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,Prenatal multivitamin every second day; vitamin C,No.,"Mild asthma, controlled",,No.,"['Ageusia', 'Anosmia', 'Cough', 'Epigastric discomfort', 'Fatigue', 'Headache', 'Impaired work ability', 'Malaise', 'Myalgia', 'Nausea', 'Neck pain', 'Neuralgia', 'Oropharyngeal pain', 'Paraesthesia', 'SARS-CoV-2 test', 'Sneezing', 'Vaccination site pain']",1,MODERNA,IM 926493,GA,44.0,F,PT DEVELOPED A MILD HIVES RASH AND ITCHY SCALP ROUGHLY 30 MINUTES AFTER VACCINATION. PT WAS GIVEN 50MG BENADRYL. PTS HIVES AND ITCHING STARTED TO FADE ROUGHLY 15 MINUTES AFTER BENADRYL WAS ADMINISTERED. PT HAD NO PROBLEMS BREATHING.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,SEN,,,,,MEAT ALLERGY,"['Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 926494,MA,29.0,F,Large itchy area of erythema and swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,PVT,N/a,None,None,,None,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA,IM 926495,,,U,"Blurred vision one eye right side blood sugar , headache, throat mild swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Blood glucose normal', 'Headache', 'Pharyngeal swelling', 'Vision blurred']",1,PFIZER\BIONTECH,IM 926496,TX,34.0,F,30 min after administration the left side of my face went slightly numb. I also got a really bad head ache and nausea. Also neck stiffness on the same side of injection side. Next day numbness in face had gone away. But head ache and nausea was the same if not worse. Also stiffness in neck was still there.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,Warafin 14mg,none,Blood Clotting issue. I have a Protein C and S deficiency,,cinnamon,"['Headache', 'Hypoaesthesia', 'Musculoskeletal stiffness', 'Nausea']",1,MODERNA,SYR 926497,IL,38.0,F,"initial mild soreness then later in day 12-29-20 developed 3 in knot red and warm, gradually spread to 10 inch diameter red, warm and painful. continues red and warm to touch and painful today",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PUB,"Lisinopril, Adderall, Prilosec, Albuterol, topical eczema cream and Kenalog injection ( last dose April 2020), melatonin",none,"asthma, eczema",,"adhesive tape ,CT dye","['Erythema', 'Induration', 'Pain', 'Skin warm']",1,MODERNA,IM 926498,MN,32.0,F,"Started with fatigue, dizziness, red face, headache on 1/6/2021 Upon waking on 1/7/2021, Whole body pains/ aches, soreness in all joints and worse on whole left side of body, extremely tired and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Citrizine Vitamin D Singular Prenatal vitamins,None,Marfan syndrome Celiac disease,,"Shellfish, gluten, mint essential oils, cinnamon, naproxen, wheat, gluten, grass, dust mites, bees","['Arthralgia', 'Dizziness', 'Erythema', 'Fatigue', 'Headache', 'Pain']",1,PFIZER\BIONTECH,SYR 926499,IN,20.0,F,Patchy red spots at Injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Birth Control,None,None,,None,"['Injection site reaction', 'Rash erythematous']",1,MODERNA,IM 926500,IL,45.0,M,"Patient received vaccination approximately at 10:45 am, he had told immunizer he had felt nervous and had fainted previously with other vaccinations. Patient was monitored after vaccination patient said he felt dizzy, approximately 11:15 am he feel forward from chair and was attended to by staff. EMTs were called and patient was taken to hospital for observation. After vaccination pt had blood pressure readings of 130/80 5 min after 150/80 15 minutes after his blood sugar readings reported by family member on scene were 325 the previous evening and 255 the morning before he came in. EMTs took a blood sugar reading 365 upon their arrival.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,SEN,Pt diabetic,pt diabetic with history of fainting after immunizations,pt diabetic with history of fainting after immunizations,pt self reported but actual vaccine unknown,none,"['Blood glucose increased', 'Dizziness', 'Fall', 'Nervousness']",1,PFIZER\BIONTECH,IM 926501,NJ,33.0,M,"Patient called stating: Nausea, muscle pain, light headed",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Dizziness', 'Myalgia', 'Nausea']",1,PFIZER\BIONTECH,IM 926502,IL,39.0,F,Right sided facial numbness and tingling,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/24/2020,3.0,WRK,Pravastatin,,High cholesterol,,Sulfa,"['Hypoaesthesia', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 926503,FL,69.0,F,"Injection site is tender, red & hard. About 3 inches in diameter. Applying heat and taking ibuprofen starting today 1/7/2021. No fever or other symptoms. contacted family physician. I will call him tomorrow, 1/8/2021, if no improvement.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PUB,hydrochlorothiazide multi-vitamin calcium losartan,no,no,,no,"['Injection site erythema', 'Injection site induration', 'Injection site pain']",1,MODERNA,IM 926504,NM,58.0,F,On January 6 i developed a rash on the injection site and 1 day after skin is peeling off,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/06/2021,8.0,PVT,Multivitamin Calcium vitamin Biotin Fish oil,None,None,,Latex,"['Injection site rash', 'Skin exfoliation']",UNK,MODERNA, 926505,GA,63.0,F,"Extremely tired, nauseous, body pain, headache, low grade temperature. Started the evening of the vaccine 1/5/21 and symptoms has gotten worse.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Ibprophen, vitamin c, turmeric",None,HTN,,"Tylenol, asa, codeine","['Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 926506,GA,60.0,F,"Body aches, fever, chills, headache, weakness, no appetite, nausea . Thus started in the middle of the 1st night till the middle of the night the 2nd night",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,MIL,"Valsarten, Effexor, simvastin, estradiol, clonazapam",None,"Anxiety, HTN, hyperlipedemia",,Nka,"['Asthenia', 'Chills', 'Decreased appetite', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 926507,NC,54.0,F,Patient stated that she was feeling nauseous about 15 minutes after administration. Patient stated that she ate some food and took som acetaminophen and was feeling better as of 2:42 PM.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,not available,not available,not available,,not available,['Nausea'],1,MODERNA,IM 926508,KS,60.0,F,Fever as high as 103.5. Chilling and dizziness. Last about 12 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,unknown,Covid - 19 Oct. 2020,Mitral Valve Replacement Kidney stones,,No known allergies,"['Chills', 'Dizziness', 'Pyrexia']",1,MODERNA,IM 926509,WI,39.0,F,"Dizziness, severe headache, abdominal pain, diarrhea, nausea, fatigue, and muscle pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Setraline, vit c & d, magnesium, iron, stool softener",,,,Vicodin and Amitriptyline,"['Abdominal pain', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,IM 926510,TX,39.0,F,"Approx 2 minutes after injection I felt warm, flush, tachycardic, dizzy, my hands were shaking and my throat felt numb and a little swollen. I was still able to swallow and symptoms did improve after 15 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Multivitamin,None,None,,None,"['Dizziness', 'Flushing', 'Pharyngeal hypoaesthesia', 'Pharyngeal swelling', 'Skin warm', 'Tachycardia', 'Tremor']",1,PFIZER\BIONTECH,IM 926511,TX,41.0,F,"A red circle about 1"" in diameter appeared on my right arm beginning the morning of 1/1/21. The circle was not in the same place as the injection site. By 1/4/21 the circle was fine and gone. The circle appeared again 1/6/21, and was more itchy and deeper in color. When I awoke the morning of 1/7/21 the circle had gotten larger in size and also other small circles appeared further up my arm. I took a antihistamine medication, Benadryl medication and have iced my arm today, but the circle and bumps are spreading further. My arm is very warm, itchy and tingly. I contacted my clinic and they suggested I report the adverse event via the VAERS.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,UNK,"Birth control pills, multivitamin, turmeric capsule, melatonin",None,None,,None,"['Erythema', 'Paraesthesia', 'Pruritus', 'Rash', 'Skin warm']",1,MODERNA,SYR 926512,AZ,21.0,M,"HEADACHE, SHORTNESS OF BREATH, INCREASED HEARTRATE, FEVER, MUSCLE ACHE, NAUSEA RASH AT SITE, CHILLS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,NONE,COVID + ON 12/7/2020,NONE,,NONE,"['Chest X-ray', 'Chills', 'Dyspnoea', 'Electrocardiogram', 'Headache', 'Heart rate increased', 'Injection site rash', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,IM 926513,OR,49.0,M,"moderate injection site pain and swelling, fatigue after 1 day from vaccination, day 2 from vaccination developed unwell feeling and congestion, scratchy voice, and worsening fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/07/2021,2.0,WRK,,"fatigue, muscle ache, congestion one week prior to vaccine",none,,"ampicillin, bee venom","['Condition aggravated', 'Dysphonia', 'Fatigue', 'Injection site pain', 'Injection site swelling', 'Malaise']",1,PFIZER\BIONTECH,SYR 926514,WA,43.0,M,"Physician came in to get 2nd Pfizer vaccine early. Two physicians came in together (husband and wife) and stated they were able to schedule early. One was given the vaccine and the other was not. When he showed the RN the vaccination card, she noted it was early, but provider stated he was going to Germany for 18 days and needed it early. Vaccine given. Second provider was counseled that it was too early and was not given vaccination. No adverse reactions reported but this is a medication error as dose 2 was given too early.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Inappropriate schedule of product administration', 'No adverse event']",2,PFIZER\BIONTECH,IM 926515,,53.0,F,"Delayed injection site swelling, erythema, small vesicles at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site swelling', 'Injection site vesicles']",1,MODERNA,IM 926516,CA,42.0,F,fatigue body chills dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,UNK,,,,,,"['Chills', 'Dizziness', 'Fatigue']",1,MODERNA,SYR 926518,OH,63.0,M,"RASH STARTED IN THE ANTERIOR WAIST , AND BIALTERAL LOWER LEGS ABOUT 30 HOURS AFTER VACCINATION. THE RASH EXTENDED TO THE ANTRIOR PELVIS, THIGH , UPPER ABDOMEN, ANTERIOR NECK AND FOREARM, AND EXTEND TO THE UPPER ARM IN 48 HOURS. THEN ABDOMINAL RASH DESAPPERED. NO-MINIMAL ITCHING, NO FIEVER , NAUSEA OR DIARRHEA. MINIMAL HEADACH AND ABDOMINAL PAIN. NO TREATMENT.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"MTOPROLOL 50 MG, LISIONOPRIL 10 MG, SIVASTATIN 20 MG, ASPIRIN 81 MG, VIATMIN D3 1000UNIT, MULTIVIATMIN, VITAMIN C 500MG",NONE,HYPERTENSION,,"PENICILINS, CEPHALOSPORIN, CLINDAMYSIN","['Abdominal pain', 'Headache', 'Rash']",1,MODERNA,IM 926519,NJ,56.0,F,"Pfizer-BioNTech COVID- 19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2020. On 12/26/2020, the area on the left arm where the vaccine was administered started to get sore again, numb to the touch, and was throbbing sometimes. She reported that when she raises her arm up, it feels like something is tearing and sometimes feels weak. On 12/27/2020, she woke up with vertigo which subsided but has been lightheaded ever since and feeling off-balance. She also reported to have loud noises coming from her ears described as hissing sounds. This has been constant. She noted that years back, on two separate times she received chemotherapy treatment which really affected her ears. It felt like there was pressure and same kind of noises. She is pending occupational health follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/26/2020,7.0,WRK,"Calcium, Magnesium, Zinc, Vitamin D, Allegra, Protonix, Levothyroxine, Irbesartan",None,History of Cancer,,Penicillin,"['Asthenia', 'Balance disorder', 'Dizziness', 'Injection site hypoaesthesia', 'Pain', 'Tinnitus', 'Vaccination site pain', 'Vertigo']",1,PFIZER\BIONTECH,IM 926520,TX,47.0,F,"Headache, fever, muscle pain, joint pain, chills, fatigue, pain at injection site, overall not feeling well",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,None,NONE,Anemia Hypercholesteremia,,"Penicillin, Sulfa","['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 926521,NE,,M,"Temp of 103.7, heart rate 120, respirations 36, Blood pressure 164/60, Oxygen level 94% @ 2 liters per nasal canola. States does not feel well. Flushed face with heavy breathing. Transported to Medical Center ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,SEN,"DOXYCYCLINE, HUMALOG, DILTIAZEM, LISINOPRIL, HYDROCHLOROTHIAZI",,"COPD,",,"Chlorphenromine, erythromycin, influenza virus vaccine.","['Body temperature increased', 'Dyspnoea', 'Flushing', 'Malaise']",1,PFIZER\BIONTECH,SYR 926522,,29.0,F,"Lips and mouth felt numb, tongue felt thick. Able to breathe without problems. Observed for 1 hour and 15 minutes. Released from observation. Was on hold to talk with medical provider when she left.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PUB,,,,,,"['Hypoaesthesia oral', 'Tongue disorder']",1,MODERNA,IM 926524,CA,36.0,M,"Fever, Body Aches, Headache, Tachycardia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,None,Covid-19 12/5/2020,None,,None,"['Chest X-ray abnormal', 'Electrocardiogram abnormal', 'Full blood count normal', 'Headache', 'Interstitial lung disease', 'Laboratory test normal', 'Pain', 'Pyrexia', 'Tachycardia']",UNK,MODERNA,IM 926525,FL,60.0,F,"large round reddened area at injection site, slightly hard to the touch, warm, itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/03/2021,4.0,PVT,"synthroid, multi-vitamin",,hypothyroid,,"Sulfa, Cefalosporins","['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",UNK,MODERNA,IM 926526,CO,47.0,F,"Tingling/numbing of lips and sides of tongue within 10 minutes of COVID Moderna vaccination. Tongue tingling resolved withing 15 minutes, lip tingling resolved within 20 minutes per patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,unknown,unkown,unknown,,"Percocet, Vicodin, antipsychotic medications.","['Hypoaesthesia oral', 'Paraesthesia oral']",1,MODERNA,IM 926527,SC,27.0,F,After I got the vaccine I started exp chills and body ache on 12/22.I went to employee health to get tested. Since then I returned to work on 1/4 still can't smell/taste .I have to wait 90 days until I receive my 2nd dose Covid vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/22/2020,5.0,PVT,Birth Control,No,No,,No,"['Ageusia', 'Anosmia', 'COVID-19', 'Chills', 'Influenza virus test negative', 'Pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 926528,CA,26.0,F,"Moderna COVID-19 Vaccine EUA 12/28- vaccinated, felt like I was punched in the arm, headache 8 hours later 12/29-very bad pain at injection site and weakness in that arm, intense headache throughout the entire day, body aches especially in knees and back, exhaustion, mild nausea 12/30- pain and weakness at injection site, mild headache, mild joint pain, throat felt scratchy, mild itchy rash on waist (red/pink with some bumps, golf ball sized) 12/31- pain and weakness at injection site, mild head and joint aches 1/1- 1/5 head ache 1/5 - 1/7 itchy, puffy, red rash at injection site, tennis ball sized, hot to touch, puffiness feels firm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,WRK,Lysine Vitamin B-12 Vitamin C,Herpes (HSV-1) Scoliosis,Herpes (HSV-1) Scoliosis,,shellfish,"['Arthralgia', 'Back pain', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site reaction', 'Injection site warmth', 'Muscular weakness', 'Nausea', 'Oropharyngeal discomfort', 'Pain', 'Rash', 'Rash erythematous', 'Rash pruritic', 'Skin swelling']",1,MODERNA,SYR 926529,GA,54.0,F,"1 WEEK POST-INJECTION--NEW ONSET 5X5CM RAISED, RED, ITCHY AT INJECTION SITE",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,PVT,ALDACTONE NEXIUM VITAMIN D TUMERIC MOBIC,NONE,STATES NONE (ALTHOUGH IS ON MEDICATION),,NO,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 926530,NY,44.0,F,"Starting at 10pm, fever (103), chills, rigors, night sweats, headache, muscle aches,. Intense fatigue. Now at 41 hours after symptoms started, fever down to 101s but symptoms persist (slightly better in intensity). Feel absolutely terrible.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,UNK,None,None,None,,None,"['Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Myalgia', 'Night sweats', 'Pyrexia']",1,MODERNA,IM 926531,NE,90.0,F,"01/06/2021 - 08:08 Complaining of fullness in the midepigastric area. Upset stomach. Dizzy. Nauseated. Temperature is 98.1, pulse 56, respirations 19, oxygen saturation 93% on room air and blood pressure 133/73. HGB 8.8.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,SEN,"LOSARTAN,SIMVASTATIN,PROMETHAZINE HCL-CODEINE PHOSPHATE,",,"hypertension, asthma, dementia, gi bleed.",,"Erythromycin, Lidocaine, aspirin, penicilin","['Abdominal discomfort', 'Abdominal distension', 'Computerised tomogram abdomen', 'Dizziness', 'Haemoglobin decreased', 'Nausea']",1,PFIZER\BIONTECH,IM 926532,MO,85.0,M,all over body rash,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,SEN,,,,,,['Rash'],UNK,MODERNA,IM 926533,IN,27.0,F,"Hives across chest and upper abdomen (developed around start of symptoms 1800-1830 1/5/21), dizziness, full body aches continuing 48 hours after vaccine received",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Prenatal vitamin, ondansetron, doxylamine succinate and B6, Claritin, famotidine, acetaminophen",,Pregnancy,,"Pineapple, seasonal","['Dizziness', 'Pain', 'SARS-CoV-2 test', 'Urticaria']",1,MODERNA,IM 926534,CA,31.0,F,Diarrhea for about 12 hours; took imodium and it went away; went to get co-vid testing because I had to work the next day. Covid test was negative.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/26/2020,5.0,PVT,Famotidine 80 mg/day Spironolactone 50 mg/day,none,GERD,,allergy to Ofloxacin,"['COVID-19', 'Diarrhoea', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 926535,TX,34.0,F,"Chills, fever, full body muscle aches, diarrhea, nausea, headache, sore throat, ear pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,UNK,"Labetolol, famotidine, prenatal, emergen-c packet, vitamin D",Miscarriage (3 weeks ago),"Asthma, HTN, GERD",,"Latex, shellfish","['Chills', 'Diarrhoea', 'Ear pain', 'Headache', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 926536,NJ,51.0,F,"After receiving the first dose of the Moderna vaccine on 1/4/21 at 8:30 am, all was well and I returned to work. As the day went on the only encounter I had was soreness at the injection site. But, the next day, Tuesday 1/5/21 @ around 10:00 in the morning while showering a notice that I had lump that looked to be swollen under my left arm where the injection was administered. I thought it was the medicine working its way through the body, and would resolve in a few days. But on today, Thursday 1/7/21 it is still there. So since I had to work today, I decided to go to Medical Center at my job for someone there to witness what was going on. Person, from Medical Center gave me the number to the hotline and advised me to call immediately. So I returned to my floor and placed the call.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,,NONE,Hypertension,,NONE,"['Axillary mass', 'Injection site pain', 'Oedema peripheral']",UNK,MODERNA,SYR 926537,WA,56.0,F,"Rash, itching, facial flushing/redness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,UNK,None,None,None,,Penicillin,"['Erythema', 'Flushing', 'Pruritus', 'Rash']",2,PFIZER\BIONTECH,SYR 926538,NJ,56.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2020. On 12/26/2020, the area on the left arm where the vaccine was administered started to get sore again, numb to the touch, and was throbbing sometimes. She reported that when she raises her arm up, it feels like something is tearing and sometimes feels weak. On 12/27/2020, she woke up with vertigo which subsided but has been lightheaded ever since and feeling off-balance. She also reported to have loud noises coming from her ears described as hissing sounds. This has been constant. She noted that years back, on two separate times she received chemotherapy treatment which really affected her ears. It felt like there was pressure and same kind of noises. She is pending occupational health follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/26/2020,7.0,WRK,"Calcium, Magnesium, Zinc, Vitamin D, Allegra, Protonix, levothyroxine, irbesartan",None,History of Cancer,,Penicillin,"['Asthenia', 'Balance disorder', 'Dizziness', 'Hypoaesthesia', 'Pain', 'Pain in extremity', 'Tinnitus', 'Vertigo']",1,PFIZER\BIONTECH,IM 926539,OK,46.0,F,Sore arm- lasted 3 days. Moderate intensity Fatigue- 24 hours Nausea and dizziness-2 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,Lyrica Sertraline Busipar Turmeric Magnesium Oxide Toviaz Bactrim Zyrtec Prevacid,,,,,"['Dizziness', 'Fatigue', 'Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 926540,CO,47.0,F,"Tingling/numbness to lips, sides of tongue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,unown,unknown,unknown,,"Percocet, Vicodin, antipsychotics","['Hypoaesthesia oral', 'Paraesthesia oral']",1,MODERNA,IM 926541,TX,45.0,F,Patient presented to clinic stating that she had started to run a fever as high as 102 and pain to lymph nodes under left axilla and neck,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,none,None,None,,NKDA,"['Lymph node pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 926542,AL,41.0,F,"tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. Heart rate was normal and skin felt normal to touch per medical staff. Patient denied shortness of breath, itching, no rash noted. Medical Authority, assessed patient, ordered Benadryl 25mg po. Patient intially denied need to take Benadryl, advised patient will need to be observed in emergency department. Patient did not want to go to the ED and instead took Benadryl 25mg po. Patient was monitored for 1 hour and 10 minutes, 55 minutes after Benadryl given. Patient felt ready to leave at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Feeling hot', 'Heart rate normal', 'Hyperhidrosis', 'Palpitations', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 926543,NC,48.0,F,"Patient stated that she had a headache and felt like she was having an out of body experience. She later complained that she was experiencing pain in her temples, occipital lobe and sinus cavity, with a pounding sensation. At 2:30 PM she stated she was feeling better and left the clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,UNK,not available,patient states that she has lung damage from chemical exposure and has suffers from migraines.,Respiratory issues and migraines. There may be others that I am unaware of.,,not that aware of,"['Autoscopy', 'Headache', 'Sinus pain']",1,MODERNA,IM 926544,CA,50.0,F,"On 1/3/2021 (4 days after first dose). I have 2 vesicular lesions on right hand, 3/4 digits, very similar to HSV type finding. Round, red, fluid filled lesions, 2-4mm, non pruritic and slightly tender. Not a adverse event, but a strange skin finding that I wonder could be due to Covid vaccine? Definitely resembles Covid toes/fingers but very mild. I?ve never had before so very strange. Thought I would report it. I have pictures should want. Otherwise I?m fine! Not even a sore arm!",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/03/2021,4.0,OTH,,No,No,,No,['Skin lesion'],1,MODERNA,IM 926546,CT,28.0,F,Perioral numbness Lump in throat Difficult swallowing,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,SEN,Unknown,None,None,,Pork Peanuts Ibuprofen,"['Dysphagia', 'Hypoaesthesia oral', 'Sensation of foreign body']",1,PFIZER\BIONTECH,IM 926547,TX,51.0,M,Vaccine received on 1/6/2021 at 0810. Symptoms of fever (tmax 102.5) and body aches began at 18:00 on 1/6/2021. Still has fever but improves with tylenol.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,,,,,,"['Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 926548,NC,32.0,F,"Dr notified of patients symptoms at 1423 and follow up at 1430. Orders received to follow 25 mg dose benadryll with 25mg more. 1449 HR increased to 117, O2 sat 94 %. Epi held and EMS called. 1449 EMS arrival, patient transported to MC.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,Unknown,Unkown,None known,,Ibuprofen,['Heart rate increased'],1,PFIZER\BIONTECH,IM 926550,NY,32.0,F,"Muscle aches throughout body, chills, nausea, vomiting. Muscle aches and chills worse the day after, almost completely gone day after that. Threw up around 7 hours after the vaccine. Only slight nausea after that.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Chills', 'Myalgia', 'Nausea', 'Vomiting']",UNK,MODERNA, 926551,MS,46.0,F,"fever, chills, tiredness, headache, nausea, vomiting, and stomach ache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,None,COVID-19 Dec. 18-Dec. 28 2020,"High Blood Pressure, High Cholesterol, Depression, Anxiety, Asthma, Acid Reflux, and Migraines",,Septra and Codeine,"['Abdominal pain upper', 'Chills', 'Fatigue', 'Headache', 'Influenza virus test negative', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,SYR 926552,IN,34.0,F,"diarrhea, cramping, nausea, severe sweating, low temperature (95F), dizziness, weakness - unable to get off the bathroom floor at work duration of symptoms: 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,,none,none,,none,"['Asthenia', 'Body temperature decreased', 'Diarrhoea', 'Dizziness', 'Hyperhidrosis', 'Mobility decreased', 'Muscle spasms', 'Nausea', 'SARS-CoV-2 test']",1,MODERNA,IM 926553,CA,30.0,F,"Headache, arm pain, and chill",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,SEN,,,,,,"['Chills', 'Headache', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 926554,,41.0,F,after receiving vaccine patient has hives on arm & body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,WRK,,,,,,"['Pain', 'Urticaria']",2,PFIZER\BIONTECH,IM 926555,,45.0,F,"nausea, hot flashes were noted, pt BP 162/98; Spo2 98%; HR 69. Pt given water and waited for extended period. Pt stated she felt better and was able to ambulate independently. A/O x4",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Hot flush', 'Nausea']",UNK,PFIZER\BIONTECH,IM 926556,MN,41.0,F,"I developed a rash ( almost the size of a credit card) Wednesday morning at the site of injection. The rash has since increased in size, but not by much. It still itches, but I have not itched it. It's not a terrible itch, but annoying. No other symptoms noted at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PUB,Prozac 20mg daily,none,none,,none,"['Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 926557,UT,20.0,F,"Swelling in the entire arm, extreme pain in the injection site, headache, minor hives on legs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,"Sertraline/Zoloft, BuPropion/WellButrin",,Obesity,,Allergy to melons and sulfa drugs,"['Headache', 'Injection site pain', 'Peripheral swelling', 'Urticaria']",1,MODERNA,IM 926558,MN,24.0,F,"Fatigue, nausea, headache, hives on tops of feet",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Just started taking some vitamins - biotin, Krill Oil, Vit D No prescriptions","Just a minor sore throat, but no sore throat today",Only the physical urticaria,Would have the same type of reaction after the flu vaccine,NKDA Cilantro Has a really high chance to have hives develop on her body. * Physical urticaria,"['Fatigue', 'Headache', 'Nausea', 'Urticaria']",2,MODERNA,IM 926559,CO,49.0,F,"Medical Imaging Associate - Received vaccine on 12/18/20 @ 0845hrs. Associate has developed neck/arm soreness, chills, and hives/welts on her face, neck, back, and thighs. The associate is taking Benadryl and self-monitoring her symptoms currently from home. The associate was instructed to seek medical attention if symptoms worsen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,,,,,,"['Chills', 'Neck pain', 'Pain in extremity', 'Urticaria']",1,PFIZER\BIONTECH,IM 926561,TX,38.0,F,"This 38 -year-old female patient reported that soon after she received the injections she napped and felt the nap was due to the vaccine. Then, at 1700 the patient was asked how she felt and the patient stated that she felt very very good. In the morning of December 31, 2020, the patient reported pain at the injection site, the patient was then treated with Tylenol 650 mg at 0934 with positive results. On the evening the patient reported anxiety, a sore throat and pain to the left arm due to recently receiving her COVID vaccination. The patient was then treated with Hydroxyzine 25 mg PRN, Cepacol Lozenge, and Tylenol 650 mg; the medications were effective.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Anxiety', 'Injection site pain', 'Oropharyngeal pain', 'Pain in extremity']",1,MODERNA,IM 926563,IL,65.0,F,"Sore arm in evening. Next day early in AM shaking and chills and pain, headache, fever 101.6, fatigue ; PM loose bowel movement and vomit (1x)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Prempro, Spironalactone, Pantoprazole, simvistatin, plavix, melatonin,","12/15/2020 Fever 7 days Augmentin for sinus infection, Covid-19 test 12/14/2020- negative",Kidney disease,,codeine,"['Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 926564,NC,33.0,M,I am now having nose bleeds. It a constant but slow bleed.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/28/2020,27.0,UNK,None,None,None,Anthrax,None,['Epistaxis'],2,MODERNA,IM 926565,TN,39.0,F,"local reaction redness, tenderness, edema, warm to touch, fatigue -patient monitored for progression of symptoms 1 week later symptoms reappeared except there is absence for edema and tenderness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,"Synthroid, Mobic, Zyrtec, albuterol inh.",None,"hypothyroidism, seasonal allergies",Influenza vaccine 2018/2019,"Compazine,promethazine","['Erythema', 'Fatigue', 'Local reaction', 'Oedema', 'Skin warm', 'Tenderness']",1,MODERNA,IM 926567,TX,50.0,F,"MIGRAINE HEADACHE BEGAN ABOUT 2 HOURS POST INJECTION, BODY ACHES BEGAN ABOUT 3:30PM, THROBING PAIN AND SWELLING TO INJECTION SITE BEGAN AT APPROXIMATELY 10:00 PM. TOOK TYLENOL 500MG AT 1:45pm THEN AGAIN AT 10:30 pm, also applied ice to injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,MIL,PRENATAL ONCE DAILY MULTI VITAMIN DAILY VITAMIN C DAILY VITAMIN D DAILY SYNTHROID 137.5 MG DAILY,NONE,HYPOTHYROIDISM Dx ABOUT 29 YRS AGO,,NKDA,"['Injection site pain', 'Injection site swelling', 'Migraine', 'Pain']",1,PFIZER\BIONTECH,IM 926568,,77.0,M,patient declined 12/30/2020 and was transferred to hospital where he did not respond to treatment and passed away 1/4/2020,Yes,01/04/2021,Not Reported,Yes,,Not Reported,,12/28/2020,12/30/2020,2.0,UNK,"alprazolam, amlodipine, ASA, cilostazol, advair, lamotrigine, ,losartan, metoprolol,omprazole,simvastatin",chronic medical problems as noted below,"dementia, peripheral vascular disease, COPD, hypertension, GERD, S/P CVA with stent of left carotid ,right common iliac and right external iliac arteries, CDK,diabetes",,"clopidigrel, sulfa, vicodin","['Absence of immediate treatment response', 'Death']",1,PFIZER\BIONTECH,IM 926569,GA,19.0,F,"patient c/o sore throat, feeling tired and muscle aches after vaccination. Has been taking tylenol and feeling better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,,,,,,"['Fatigue', 'Myalgia', 'Oropharyngeal pain']",1,PFIZER\BIONTECH,IM 926571,CA,57.0,F,"One week after receiving vaccination right deltoid area became itchy, bumpy, are hardened with slight discoloration",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,PVT,"Calcium, Calcitriol 0.25 mcg, HCTZ 50 mg, Magnesium Oxide, Prometrium 100 mg, Estradiol 0.5 mg, Multivitamin",None,Idiopathic hypoparathyroidism,,NKA,"['Injection site discolouration', 'Injection site induration', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 926572,IN,18.0,F,3 inch long rash around vaccination site. Sharp shoulder pains above vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,,,,,,"['Vaccination site pain', 'Vaccination site rash']",UNK,MODERNA,SYR 926573,PA,36.0,M,Patient called stating he woke with a fever 100.7. Will call and report if no better,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,PVT,,,,,,['Pyrexia'],1,MODERNA,IM 926574,IN,20.0,F,Patchy red spots at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Birth Control,None,None,,None,['Injection site rash'],1,MODERNA,IM 926575,MD,33.0,F,"The vaccination site became red, hard to the touch, warm and inflamed on 1/4/20 (similar to a bad sting). On 1/5/20, the left arm could not be moved without being in pain. On 1/6/20 there was slight eye swelling on the left eye that persisted until 1/7/20, but did subside. The vaccination site is still red, hard, and warm on 1/7/20, but the pain has subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,None,Sinus Infection one week prior - fully recovered at time of vaccination,Obesity,,None,"['Eye swelling', 'Injected limb mobility decreased', 'Injection site erythema', 'Pain', 'Pain in extremity', 'Vaccination site induration', 'Vaccination site inflammation', 'Vaccination site warmth']",1,MODERNA,IM 926576,KS,57.0,M,Employee reports chilling and aching all over.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,Unknown,none,high Blood Pressure,,No known allergies,"['Chills', 'Pain']",1,MODERNA, 926577,CO,54.0,F,"After receiving the COVID-19 vaccination the patient experienced the following adverse events itching and red blotchy skin upper mid chest, lower neck. tingling of the lips 1/6/21 approx 1310 patient began to report itching of right arm and tingling. Sx progressively developed redness itchiness, mid upper neckline, reported feeling swelling. VITAL SIGNS at 1324: BP 188/110, HR 81, 02 100% RA, RR 20,.During vital signs, patient reported swelling on her neck, she refused to be transported to ED by WC, walked to ED, a/ox3. Once patient checked in to ED, she began to report tingling of the upper lips. She was then checked into ED room, this RN remained at her side until she was taken to the back. VAERS documented. Patient advised 2nd contraindicated.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,unknown,unknown,unknown,,None,"['Erythema', 'Paraesthesia', 'Paraesthesia oral', 'Pruritus', 'Rash macular', 'Swelling']",1,MODERNA,IM 926578,MO,46.0,F,"Presented to ER 12/23/2020 with Lightheadedness, chills, nausea, vomiting, rash. Iv fluids and antiemetics administered, pt reported feeling better. RX for Medrol Dosepak given.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,PVT,,,,,Bupropion,"['Chills', 'Dizziness', 'Nausea', 'Rash', 'Vomiting']",1,PFIZER\BIONTECH,IM 926579,WA,26.0,F,An hour after receiving the first dose of the Moderna vaccine I experienced mild blurry vision. This lasted about 30 minutes then went away with no other problems.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,None,None,Obesity,,None,['Vision blurred'],1,MODERNA,SYR 926581,MT,50.0,F,"Red around injection site, firm to the touch, warm, neck muscle soarness (above injection site)",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/07/2021,10.0,PVT,non,non,non,,penicillin,"['Injection site erythema', 'Injection site induration', 'Injection site warmth', 'Myalgia', 'Neck pain']",UNK,MODERNA,SYR 926582,FL,57.0,F,"Red,swollen,raised circle/bump at/below injection site-VERY painful & itchy. Dizzy & somewhat nauseous on 1/6/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,,none,,,,"['Dizziness', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Nausea']",1,MODERNA,IM 926583,MO,34.0,F,"Approx 8 hours after injection developed soreness in L arm, as well as L-sided cervical, axillary, breast, and inguinal lymphadenopathy. Woke up in the middle of the night that night with awful chills. Fever of 101.4 F that persisted throughout the next day along with severe fatigue and body aches. Symptoms began resolving after approx 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Fluoxetine 20 mg daily Mirena IUD,None,None,,None,"['Chills', 'Fatigue', 'Lymphadenopathy', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 926584,NC,47.0,F,"Pt received vaccine felt light headed lowered to floor 96HR 99% no respiratory distress, no allergic rx, no loc. EMS called pt declined transport vs wnl FSBG 93 EMS left and pt lightheaded again lowered to floor MD/EMS called and pt taken to the hospital",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,Unknown,Unknown,Unknown,,"Prednisone, Adhesive",['Dizziness'],1,PFIZER\BIONTECH,IM 926585,OR,51.0,F,Bad taste in mouth within 15 minutes of shot. Head to toe flushing and feeling hot and prickly within 1 hour of shot. shortness of breath and wheezing followed. Treated with PO Benadryl and zantac and albuterol inhaler.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,"Zyrtec, levothyroxine, spironolactone, metoprolol succinate, calcitriol, liothyronine, buproprion",none,"postsurgical hypothyroidism, HTN, seasonal allergies, dysthymia",,,"['Dyspnoea', 'Feeling hot', 'Flushing', 'Pain', 'Taste disorder', 'Wheezing']",1,MODERNA,IM 926586,FL,64.0,M,blistering on top of fingers just below nails,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,01/04/2021,18.0,PVT,lisinopril 10mg,none,mild hypertension,,none,['Blister'],1,PFIZER\BIONTECH,IM 926588,MD,25.0,M,"Patient received covid vaccine and went to observation room for 15 minutes. While sitting in observation room patient began c/o of dizziness. Staff RN in observation room elevated patient's feet on a second chair. Patient had normal pulse ox, HR and RR. After another 10-15 minutes, patient began c/o of chest pain and EMS was called. Ambulance took patient to ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,Unknown,Unknown,None (per screening checklist),,Unknown,"['Chest pain', 'Dizziness']",1,MODERNA,IM 926589,UT,30.0,F,"For 48 hours following injection, mild to moderate injection site pain was experienced. 5 days after the injection, symptoms including headache, body aches, fatigue lasting 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/04/2021,5.0,PVT,"Amitriptyline 25 mg, Flonase, Vitamin D",None,None,,Latex,"['Fatigue', 'Headache', 'Injection site pain', 'Pain']",1,PFIZER\BIONTECH,IM 926590,GA,30.0,M,"Client returned to Clinic reporting ""Tightness in the back of his throat"". Denied difficulty breathing or other symptoms. Patient was clearing his throat periodically. Patient states he has anxiety, so he also believes that is adding to his symptoms. After checking vitals administered epi and dial 911. Patient had started to clear his throat more often. Continued to monitor patients symptoms and did not have any worsening of symptoms and after approximately 5 minutes, he stated he felt better. EMS arrived and discussed with patient and he elected to refuse transport to the hospital. He has a buddy in the parking lot who drove him here.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,none reported,none reported,none reported,,none reported,"['Anxiety', 'Throat clearing', 'Throat tightness']",1,PFIZER\BIONTECH,IM 926591,NJ,48.0,F,Approximately 10 minutes after receiving the vaccine pt reported flushed area near chest. Denied itching or dyspnea. Speech clear. md notified and requested patient take benadryl 25mg oral now - given to patient. patient is under observation for 1 hour of time.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,not known,not known,not known,,"cefazolin - reaction reported as anaphylaxis, hydromorphone, diazepam",['Flushing'],1,MODERNA,IM 926592,TX,36.0,F,"redness, sore, warm, raised, tingling, hard. applied warm compress",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PVT,vitamins,none,none,,"tramadol, flagyl, minocycline","['Erythema', 'Induration', 'Pain', 'Paraesthesia', 'Skin warm', 'Swelling']",1,MODERNA,IM 926593,NH,38.0,U,"left arm felt sore. She was nauseous, dizzy and had body aches, including back pain and pain extending down left leg into foot. Left arm became swollen to the hand as the day progressed and has had difficulty moving the shoulder",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,UNK,,,,,None,"['Back pain', 'Dizziness', 'Joint range of motion decreased', 'Nausea', 'Pain', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 926594,FL,57.0,F,"Achiness, fatigue, fever, nausea, headache, loss of appetite, arm soreness Tylenol, Zoltan, rest, stay home from work 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,Warfarin 6 mg /3 mg alt days Melatonin 10 mg day Trazadone 50 mg day Vit D Trintellix 10 mg,No,Blood clotting disorder,,No,"['Decreased appetite', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 926595,AK,66.0,M,I developed a hive/rash below and above my waist line on my stomach area. I also felt bloated in my lower stomach. I noticed it when I was undressing for bed. It was a mild reaction that came and went quickly once I laid down to go to sleep. Some belching relieved the bloating in my stomach.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PHM,"Creon DR 36,000, Vitamin D3 10,000 IU, Magnesium Glycinate 1000 mg, DGL1200mg, Psyllium Husk Powder, Gaviscon 500mg.","GERD, LPR, Diarrhea","Gerd, LPR, Diarrhea",,"molds, plant pollen, mercury","['Abdominal distension', 'Eructation', 'Rash', 'Urticaria']",1,MODERNA,SYR 926596,MN,42.0,F,Left arm and fingers became numb for over 24hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,No,No,No,,No,['Hypoaesthesia'],1,PFIZER\BIONTECH, 926597,ND,37.0,F,"1-6-21 Left arm numbness and tingling, 1-7-21 Headache, body aches and chills,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Topomax, Hydroxyzine,",none,none,,none,"['Chills', 'Headache', 'Hypoaesthesia', 'Pain', 'Paraesthesia']",1,MODERNA,IM 926598,CO,64.0,F,Post COVID vaccination (received on 12/14) Had MULTIPLE episodes of palpitations lasting several minutes. These palpitations started the evening of 12/14 and continued throughout 12/15/2020,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/14/2020,12/15/2020,1.0,PVT,,,,,,['Palpitations'],1,PFIZER\BIONTECH,IM 926599,,33.0,F,Delayed (9 days) injection site erythema (hives)/itching -2 inches.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/25/2020,01/03/2021,9.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site urticaria']",1,MODERNA,IM 926600,MO,65.0,M,Patient did not report any signs or symptoms of adverse reaction to vaccine. Patient suffered from several comorbidities (diabetes and renal insufficiency). Patient reported not feeling well 01/06/2021 and passed away that day.,Yes,01/06/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,PHM,Unknown,"Diabetes, renal insufficiency","Diabetes, renal insufficiency",,"Penicillin, ibuprofen","['Death', 'Malaise']",1,MODERNA,IM 926601,CA,42.0,F,"swelling, hardness, itching at site. took Benadryl and warm compress",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,OTH,,,,,sulfa,"['Injection site induration', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 926602,VA,31.0,F,"Presumed right arm muscle injury. Several hours after the injection my arm was extremely sore and painful. The joint was painful as well. No redness or swelling. It was tender to touch. I was having difficulty reaching my arm up or moving it upward. Ex: it hurt to lift my hand to touch my face. I also couldn?t let it fall. If I got my arm above my head I would have to assist it down. I couldn?t sleep that night because of the pain. I was having trouble with pushing movements in that arm. And also letting it hang dependently (like letting my arm hang when I hinged forward). I started taking Motrin 24 hours after the injection. Motrin helped, so I took it Friday and Saturday. Sunday, my arm felt 99% back to normal. Monday and Tuesday I didn?t notice anything. Wednesday morning I woke up with the same pain again and difficulty moving my arm. Wednesday night, I couldn?t sleep again because of the pain/couldn?t get my arm in a comfortable position. I?m taking Motrin, with not as much relief as before. I?ve applied heat and I?ve tried to stretch it as well. The only way i really know how to describe it? is that it feels as if my deltoid was injured. And my other muscles are fine. It?s hindering my movement in that arm. It is again, tender to touch my deltoid area. The tightness has extended in to my shoulder and neck. It has now been 8 days since my vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,Vitamin C Elderberry Vitamin D Prenatal Multivitamin Fiber Supplement,None,None,,NKA,"['Arthralgia', 'Joint stiffness', 'Mobility decreased', 'Muscle tightness', 'Pain in extremity', 'Sleep disorder', 'Tenderness']",1,MODERNA,IM 926603,ME,49.0,F,"Flush, tingling, palpitations. Observed for 2 hours. 150/90, pulse 72, SPO2 99% -> 140/90, 68, SPO2 99%. Felt better, sent home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,none,none,history of lyme disease,,"tree nuts, environmental","['Flushing', 'Palpitations', 'Paraesthesia']",UNK,MODERNA,IM 926604,NY,44.0,F,"At day 8 noted itching, then reddness, swelling and sensitive to touch below injection site of right upper arm. It was also warm to touch. showed DO and I am giving several of these injections to staff and community and have noted more than eight occurrences of the same result and I have asked these individuals to report to us or online to document this adverse reaction. I am on day 10 at this time and it is still the same.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,"Vitamin C, E MVI Turmeric Omega",None,None,,"Sulfa, Latex and wool","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 926605,MD,52.0,F,"12/31/20 developed headache, some blurry vision, nausea and splotchy rash. Took Benadryl around 2100 and went to sleep. Woke up with tongue swelling and difficulty speaking, decided to go to emergency room on 1/1/21. When she first presented she had significant swelling noted to her tongue. SoluMedrol IV, Pepcid IV, and Benadryl IV given in ED. Also administered 0.3 mg Epinephrine. Discharged with Pepcid and Prednisone for 3 days and Benadryl prn",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,Prevacid 15 mg once a day Losartan 50 mg once a day Advil 200mg 4 tabs,None,Hypertension Acid Reflux,,"Oral Cipro (6 years ago, Hives)","['Aphasia', 'Headache', 'Nausea', 'Rash macular', 'Swollen tongue', 'Vision blurred']",1,MODERNA,IM 926606,MD,40.0,M,"About 40 minutes after I received the injection in my right arm, my right arm began to tingle all the way to my fingertips. The sensation lasted for approximately 30-40 minutes, then subsided. No other reactions so far after that. No loss of mobility in my arm or hand.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,None,None,"2017/2018- diagnosed with stage 4 Non-Hodgkins Lymphoma (NHL), treated with chemotherapy. April 2020- NHL returned in liver, treated with radiation.",,None,['Paraesthesia'],1,MODERNA,SYR 926608,OH,72.0,F,"itching, chest tightness, dizziness, shortness of breath no angioedema or anaphylaxis",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,? cyclobenzaprine (FLEXERIL) 10 mg tablet Take 1 tablet by mouth every 8 hours as needed for Muscle Spasm or Pain for up to 5 days. ? insulin glargine (LANTUS SOLOSTAR U-100 INSULIN) 100 unit/mL (3 mL) Inject 65 Units subcutaneously daily a,none,sarcoidosis DM asthma HTN history of septic joint,,"Allergies: Aspartame Swelling, Itching Comment:Swelling on face, severe itching Aztreonam Itching Benadryl [Diphenhyd* Rash, Itching Cipro [Ciprofloxaci* Rash, Itching Clindamycin Rash, Itching Comment:Chest pain when given for labial abscess in 9/2019. MI was ruled out, felt to be S/E from clindamycin Covid-19 Vaccine, M* Shortness of Breath Darvocet-N 100 [Pro* Rash, Itching Erythromycin Rash, Itching Flagyl [Metronidazo* Rash, Itching Fragrances Swelling Keflex [Cephalexin] Keppra [Levetiracet* Shortness of Breath Comment:SOB, CP, itching Lipitor [Atorvastat* Myalgia Losartan Shortness of Breath Metformin Intolerance Comment:Fatigue, joint pains, elevated CK Penicillins Rash, Hives, Itching Sulfa (Sulfonamide * Rash, Hives, Itching Tegretol [Carbamaze* Rash, Itching Terbutaline Sulfate Other: See Comments Comment:Dizziness,fogg feeling, possible SOB, leg edema, high sugars Vitamin D [Cholecal* Itching Comment:Patient states allergy is to High Dose Vit D3, Physician has changed to lower dose Vit D3","['Chest discomfort', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Metabolic function test', 'Pruritus', 'Troponin']",1,MODERNA,IM 926609,GA,42.0,F,"Diarrhea, nausea, Temp 102, body achestx with Ibuprofen with some relief",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,Vitamins,none,none,,latex sensitivity,"['Body temperature increased', 'Diarrhoea', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 926610,OH,49.0,F,"6 hours post vaccine-- > arm soreness 12 hours post vaccine-- > fever, chills, headache, body aches, sharp hip and thigh pain bilaterally 24 hours post vaccine-- > symptoms continued; taking OTC Advil 30 hours post vaccine-- > fever 102.2 with continued symptoms;taking OTC Advil 36 hours post vaccine-- > symptoms start to resolve with temp of 99.1",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,UNK,,none,psoriasis,,Anaprox,"['Arthralgia', 'Chills', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA, 926611,MO,16.0,M,1/6 a rash developed at the injection site and by 1/7 it had spread to the belly and chest.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,,,,,none,"['Injection site rash', 'Rash']",1,PFIZER\BIONTECH,IM 926612,,48.0,F,Approximately 10 minutes after receiving the vaccine pt reported flushed area near chest. Denied itching or dyspnea. Speech clear. Dr. notified and requested patient take benadryl 25mg oral now- administered to patient. patient monitored for 1 hour post vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,,,,cefazolin- reaction is anaphylaxis,['Flushing'],1,MODERNA,IM 926613,KY,46.0,F,"Large circular area developed 9 days after injection. Arm is sore, area is tender to touch. Area is swollen, red, and warm to touch. Feels like hard knot.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,PVT,Prempro 0.45 daily Omeprazole 40mg daily,,,,,"['Injection site erythema', 'Injection site indentation', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 926614,NH,38.0,F,"Blood in urine, pain in abdominal area and side lower back kidney area",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,Dextroamphetamine ibuprofen,"None, no symptoms other than normal every day allergies",None,,"Tree nuts, tomatoes, redmeat, ketamine demerol iron infusion","['Abdominal pain', 'Back pain', 'Blood urine present', 'Computerised tomogram']",1,MODERNA,SYR 926615,SC,64.0,F,I exp headache and diarrhea The next day after I was urinating blood. I went to my PCP I got Culture and given antibiotics.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,No,No,No,,Insect,"['Blood urine present', 'Culture', 'Diarrhoea', 'Headache']",1,PFIZER\BIONTECH, 926616,PA,60.0,F,"Moderna vaccine vial was opened on 12/30/2020, and the vial was placed back into the fridge later that afternoon, like 2-3 hours after puncture. The opened vial was reused for this patient the next morning for an injection when it should have been discarded. No adverse events occurred",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 926617,TX,26.0,F,"Around 11pm started having chills. Around 3:00am. fever, started shaking, had temperature 104 around 5: AM vomited and is having headache, had trouble breathing like someone was pushing on her chest last night. Now she is talking normal. Headache is bad and the light hurts her eyes.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,no,no,no,,no,"['Body temperature increased', 'Dyspnoea', 'Feeling cold', 'Headache', 'Photophobia', 'Pyrexia', 'Tremor', 'Vomiting']",1,MODERNA,IM 926618,MO,34.0,F,Body Aches and chilling,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,,,,,PENICILLINS,"['Chills', 'Pain']",1,PFIZER\BIONTECH,IM 926619,TX,47.0,F,"Approximately 5 minutes after receiving vaccine, patient experienced itching on upper lip and itching on left upper arm. Appears to have a petechial rash with redness on left upper arm. Itching is stable and not getting worse. Left arm feels a little heavy with some unusual sensation. Initial BP 155/91 HR=80. O2=98%. Repeat BP 137/90 HR=77 O2=97%. Patient declined Benadryl because the symptoms are stable and patient did not want to get sleepy from the Benadryl and patient wanted to return to work. Patient clinically stable. Patient released at 10:15am.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Progesterone,None,"lactose-intolerance, hormone imbalance, vitamin D deficiency",,"cucumber, water melon, bell pepper, strawberries, etc.","['Limb discomfort', 'Lip pruritus', 'Petechiae', 'Pruritus', 'Rash', 'Rash erythematous', 'Sensory disturbance']",1,MODERNA,IM 926620,KY,66.0,M,"18 hours after injection, patient described fever of 102.5 degrees, chills, shakes, and nausea. All symptoms resolved within 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,,No,,,Quinolones,"['Chills', 'Nausea', 'Pyrexia', 'Tremor']",1,MODERNA,IM 926621,GA,73.0,F,"Lot# is on card at work. Had COVID in April. Flu like symptoms. Tired, ached from head to toe. No appetite. Went home and slept for 5 hours. Next day felt a little better. Today she is back to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,"Boniva, once/month, Oxybutynin 5mg 2x/day, Rosuvastatin 20mg 1x/day, Xarelto 20mg evening, Timorol Malcate 2x/day. Amlodipine 5mg 1x/day. Zinc, Vitamin C. VitaminD3, Cor-omega, Ultra probiotic, Chromium.",no,A-fib.,,no,"['COVID-19', 'Decreased appetite', 'Fatigue', 'Influenza like illness', 'Pain']",1,PFIZER\BIONTECH,SYR 926622,TX,23.0,M,"Approximately 10 minutes after receiving vaccine patient began to experience some mild discomfort on the left neck (mild ""stiff neck""), heavy arm or discomfort, and mild tingling in the fingers. Initial BP 149/92 HR 91. Patient clinically stable at 30 minutes post-vaccination. Neck pain gone 30 minutes post-vaccination; patient only feels pain at injection site. BP 143/95 HR 86 O2=98%. Patient released from clinic at 2:22pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Metformin,None,"Diabetes, Migraines",,Shell fish,"['Injection site pain', 'Limb discomfort', 'Musculoskeletal discomfort', 'Musculoskeletal stiffness', 'Neck pain', 'Paraesthesia']",1,MODERNA,IM 926623,VT,53.0,F,"Started having tongue swelling about 1 hour after injection, treated myself at home with Benadryl. Around midnight increased tongue swelling, throat tightness and shortness of breathe. Went to emergency room and treated with epinephrine, steroids, Benadryl, Pepcid and required a nebulizer (duoneb). Discharged home from ER with prescription s for Prednisone, Pepcid and Benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Zyrtec,singular,Flonase,advair,vitC, B12,lyrica,",NoneAl,Allergy induced asthma. Anaphylaxis from allergy shots in the past,,"Hydrocodone, environmental allergies","['Swollen tongue', 'Throat tightness']",1,PFIZER\BIONTECH,IM 926624,CA,49.0,F,Bumps Welts Hot to touch Red super painful for a day 5 inches in diameter,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/06/2021,8.0,UNK,,,,,,"['Erythema', 'Pain', 'Skin warm', 'Urticaria']",1,MODERNA,SYR 926625,CA,28.0,F,"I developed gingivitis, it started on the right bottom side the day after the vaccine and now the inflammation is on all of my gums",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,None,None,None,,None,"['Gingivitis', 'Noninfective gingivitis']",1,MODERNA,IM 926626,TX,47.0,F,"During 15 minute observation period post vaccine: Patient develop tightness in the throat and had trouble breathing. Reported head pounding, throat swelling and sweaty feet. BP of the patient was taken by Nurse faculty at the facility and recorded at 201/110. Heart Rate was recorded at 180. Benadryl was given to the patient.(50mg total) Patient was taken to hospital by staff at facility at 11:02am. Confirmed check-in at 11:25am.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PHM,Not Know,Not Know,Not Know,,Not Know,"['Dyspnoea', 'Headache', 'Hyperhidrosis', 'Pharyngeal swelling', 'Throat tightness']",1,PFIZER\BIONTECH,IM 926627,TX,56.0,F,"Fever, chills, fatigue, itching",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,Levothyroxine 50 mcg-DLY Atenolol 50 mg DLY Chlorthalidone 25mg-DLY Lipitor 20mg-DLY Effexor 150mg-DLY Zyrtec-DLY Vitamin D 5000IU-DLY Celebrex 200mg-BID,None,Hypertension Hypothyroid,,Biaxin,"['Chills', 'Fatigue', 'Pruritus', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 926628,PA,36.0,F,"Post injection day 8 - red, itchy, raised, hive like bump at the injection site. Improving on day 9, however red bump still present. Headache also day 9.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,PVT,None,None,None,,"Penicillin, nickel","['Headache', 'Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site urticaria']",1,MODERNA,IM 926629,NY,36.0,F,"That night of the vaccine I started to have difficulty lifting my arm, then around 12:30am I was taking a shower and started feeling body ached and chills. Around 8 hours later I woke up with night sweats, and fever or 99.0 Fever started getting higher through out the day. The day after my temp was at 101. On the third day temp went away and I just felt fatigue, but I got chest tightness and the urge to clear my throat and some mucus came up. The chest tightness was two day and the mucus three days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,Baby Aspirin (daily) Vitamins- daily Immune shroom,"Sinus discomfort, dry nose, scratchy throat",Adult on set Asthma,,Penicillin,"['Chest discomfort', 'Chills', 'Fatigue', 'Mobility decreased', 'Night sweats', 'Pain', 'Pyrexia', 'Secretion discharge', 'Throat clearing']",1,MODERNA,SYR 926630,TX,30.0,F,"Left sided Migraine that lasted 3 days. I took BC powder, Excedrin, and my regular prescribed migraine meds. Nothing helped, it was relentless. I am still having some pain but not as severe. I did not seek treatment as I hate the shots they used to do before my Topamax was prescribed. I had been migraine free for a little over year before this shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/04/2021,5.0,WRK,"Topamax, Lexapro, Paxil, Amitriptyline",none,"depression, ptsd",,apricots,['Migraine'],1,PFIZER\BIONTECH,SYR 926631,PA,50.0,F,"warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u - stick neck, shoulder pain + heat, left cheek swollen been taking tylenol and benadryl saw PCP - received rx for prednisone",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,,no,,,Penicillin - shivers/tachycardia (20 years ago),"['Arthralgia', 'Blood pressure increased', 'Burning sensation', 'Chest discomfort', 'Dyspnoea', 'Feeling hot', 'Joint warmth', 'Musculoskeletal stiffness', 'Nausea', 'Swelling face']",1,PFIZER\BIONTECH,IM 926632,CO,29.0,F,I did have a headache and slight fever not to long after I got the shot. The next day my arm was super painful. Several days after the shot my arm where the injection site is was red. It then started going back to normal color. Two days ago it itched a little then the redness appeared back again and now it is hot to the touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/01/2021,3.0,PVT,"sertraline trazodone glimeperide montulekast januvia gabapentin vitamin c magesium,calcium and zinc biotin equate allergy relief",,Type 2 Diabetic,,lilies mustard clindaymyacin,"['Erythema', 'Headache', 'Injection site erythema', 'Pain in extremity', 'Pruritus', 'Pyrexia', 'Skin warm']",1,MODERNA,IM 926633,,61.0,F,Hematoma at the site of injection after 3 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/03/2021,4.0,PVT,none,none,none,,allergies to kiwi allergies to latex,['Injection site haematoma'],1,MODERNA,SYR 926634,MA,35.0,F,"Fatigue, headache and muscle pain (on site of injection).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,"Sertraline, HCl 25mg",,,,,"['Fatigue', 'Headache', 'Injection site pain']",1,MODERNA,IM 926635,CO,29.0,F,"I received the pfizer COVID vaccine Wednesday 12/16. I noted an erythematous raised warm painful confluent blanching rash on 12/18. So far I have not has SOB, fatigue, N/V - any other systemic sx.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/18/2020,2.0,PVT,,,,,,"['Pallor', 'Rash erythematous', 'Rash papular', 'Skin warm']",1,PFIZER\BIONTECH,IM 926636,PA,36.0,F,"Moderna COVID?19 Vaccine EUA Moderna vaccine vial was opened on 12/30/2020, and the vial was placed back into the fridge later that afternoon, like 2-3 hours after puncture. The opened vial was reused for this patient the next morning for an injection when it should have been discarded. No adverse events occurred",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 926637,CT,55.0,F,"12 hours after injection I had chills, body aches, fever, headache, nausea, vomited, diarrhea. Temperature was in the 101.5 range for more than 24 hours, About 30 hours with a fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,WRK,synthyroid,Nothing,hypothyroidism,,"Asprin, penicillin,","['Body temperature increased', 'Chills', 'Diarrhoea', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test', 'Vomiting']",2,PFIZER\BIONTECH,IM 926638,VA,38.0,F,5days after the shot had raised rashes right below the injected site and itchy. 2 days later the raised area has flattened but the rash site got bigger and less itchy.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/04/2021,5.0,PUB,Only vitamins,Acid reflux,None,,Shellfish,"['Injection site reaction', 'Rash papular', 'Rash pruritic']",1,MODERNA,SYR 926639,MA,56.0,F,"C/O left arm pain radiating down arm and up neck; pointed to mid-sternal area and reported ""chest twinge"". Radial pulse measured 88- pulse felt weak. Brought over to EMS for evaluation, monitor shows HR 87, BP 185/98 (160/88 manual), O2 99% on RA. HR came down to 79, BP 142/80. Around 0910 c/o nausea and dizziness. 0915 called daughter to drive her home, refused to transfer with EMT to hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,,,,,,"['Chest pain', 'Dizziness', 'Nausea', 'Neck pain', 'Pain', 'Pain in extremity', 'Pulse abnormal']",1,PFIZER\BIONTECH,IM 926640,NC,43.0,F,"Dizzy, lightheaded, shortness of breath, tachycardic Vaccine given at approximately 1612 Benadryl given at 1614. 1615 Epi in L thigh. Pt transported to ED by wheelchair",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,Unknown,Unkown,Unknown,,None,"['Dizziness', 'Dyspnoea']",1,PFIZER\BIONTECH,IM 926641,MO,47.0,F,"Pt phoned in to clinic with complaints of severely swollen, red, itchy, tender left upper arm. Pt denies any systematic reactions at this time. Referred to follow-up with PCP, pt stated she is going to send him a picture of her arm per MD request. Per pt, Dr. instructed her to elevate, ice, and to take ibuprofen/anti-histamine as well. Pt stated it started getting much better last night and is going to follow-up with PCP for order to continue series or not.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,PUB,"Vitamin D, Flonase, and Zyrtec",None,None,,Wellbutrin and Trazadone hives,"['Erythema', 'Peripheral swelling', 'Pruritus', 'Tenderness']",1,MODERNA,IM 926642,NJ,49.0,F,Patient reports arm became numb right after receiving the COVID-19 vaccine. Two hours later patient reports the numbness being limited to the bottom of the arm and hand. Patient states to being able to use hand but reports there is numbness and tingling.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,,,,,Tetanus and sulfa allergy listed with reported hives reaction,"['Hypoaesthesia', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 926643,MI,41.0,F,Insomnia lasting for 5 days at this time an continuing,Not Reported,,Not Reported,Not Reported,,Not Reported,,11/29/2020,01/02/2021,34.0,WRK,"Vitamin c, zinc",None,Controlled asthma,,None,['Insomnia'],UNK,PFIZER\BIONTECH, 926644,IL,64.0,F,"Pt reports running a temperature of 102.5 with chills that started at about 1700 and lasted 10-12 hours. After temperature lowered to ""low grade temp"" and patient reported fatigue for 2-3 days. Also reported ""lymph glands"" swollen in right side of neck, right axillary area and tenderness extending down right arm to elbow. Symptoms have resolved at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,Losartan Bid,none reported,Hypertension,,NKDA,"['Body temperature increased', 'Chills', 'Fatigue', 'Injection site pain', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,SYR 926645,OH,43.0,F,"I received Moderna dose 1 on December 29th, 2020 around 10:30 a.m. I did experience chills, body aches, extreme fatigue, pain and swelling at injection site for about 36 hours. However, symptoms seems to resolve after a couple of days. On Tuesday, January 5th around 5 p.m. at the injection site in my right arm it began to itch. By 9 p.m. I had a huge red circle around 3 inches in diameter around the injection site, it was sore, swollen, warm to the touch. itchy and lymph nodes under right axilla were swollen. I contacted my Dr. immediately the morning of Wednesday, January 6th and after assessing me she felt it was a skin infection. She prescribed Doxycycline antibiotic and Zyrtec by day, Benadryl by night. I began the antibiotic treatment with first dose on 1/6/21 at 1:30 p.m., dose 2 9:00 p.m. and dose 3 on Thursday, January 7th 2020 around 8:00 a.m. I have responded well to the treatment and already my arm is much improved. My Dr. felt it could have been the technique of the administration of the vaccine that caused infection. However, I wanted to report in case anyone else with this batch also experienced similar response.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,PVT,Women's Vitamin,None,Chronic Sinusitis,,Bactrim and Penicillin,"['Chills', 'Fatigue', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Lymphadenopathy', 'Pain', 'Skin infection']",1,MODERNA,IM 926646,CA,51.0,M,"25min after. Rapid heart rate, drop in blood pressure ER visit 1 Day 1-3headache, neck ache Day 4 heart palpitations/dizziness ER visit 2 Day 5 Heart palpitations/dizziness ER visit 3 Day 6 mild heart palpitations, bone aches in left ankle Day 7 general weakness, aching joints, tired all week, ankle still aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Symbicort, multivitamin, potassium",,No,Flu shot,"Seasonal allergies, flu shot, codein, mild wheat","['Arthralgia', 'Asthenia', 'Blood pressure decreased', 'Bone pain', 'Chest X-ray', 'Dizziness', 'Electrocardiogram', 'Fatigue', 'Full blood count', 'Headache', 'Heart rate increased', 'Neck pain', 'Palpitations', 'SARS-CoV-2 test negative']",UNK,MODERNA, 926647,IL,67.0,F,"100 degree fever, body aches, chills, insomnia overnight. Other symptoms still persist . I was unable to work today as scheduled due to these symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,Metoprolol tartrate 25mg BID,None,Osteoarthritis Hypertension,,Ancef,"['Chills', 'Insomnia', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 926648,NM,24.0,F,"Rapid heart rate >170, flushing, chills, shaking, increased blood pressure",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,None,None,,"Amoxicillin, Bactrim","['Blood pressure increased', 'Chills', 'Flushing', 'Heart rate increased', 'Tremor']",2,PFIZER\BIONTECH,IM 926649,IL,51.0,M,"PAPULAR RASH/DERMATITIS AFFECTING BOTH UPPER EXTREMITIES, NECK AND BEHIND EARS, HAPPENED 3.5 HOURS AFTER THE DOSE",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,NONE,NONE,NONE,,NONE,"['Dermatitis', 'Rash', 'Rash papular']",2,PFIZER\BIONTECH,IM 926650,OH,53.0,F,"Soreness to left arm and neck, extreme itching of hands and feet, feeling of being on fire from inside/out, fatigue. Treatment: Tylenol and Benadryl. Lasting 2 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,None,None,Arthritis Lichens sclerosis,,None,"['Burning sensation', 'Neck pain', 'Pain in extremity', 'Pruritus']",1,MODERNA,IM 926651,,57.0,F,"pt c/o tingling in B/L arms and head. pt stated she was a ""bit"" dizzy at first but sx subsided. Pt sat in view of Rn for extended time period. VS 198/108 HR92 SPO2 97. Pt VS rechecked BP 148/90 SPO2 97 HR 94 pt stated she felt better. Pt ambulated independently, RR even and unlabored, NAD noted, Skin NFR. Pt declined transport to ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Dizziness', 'Paraesthesia']",UNK,PFIZER\BIONTECH,IM 926652,WI,30.0,F,"One hour after administration adverse events noticed: major headache that continued on and off for 7+ days, metallic taste with fullness of throat on and off for a few days, following day neck and upper shoulder soreness on and off for 7 + days, general fatigue on and off for 7+ days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,Vaginal Progesterone,None,"PCOS, endometriosis","Yes chills, fatigue, body aches with flu vaccine in 2019 the night after vaccination",Seasonal,"['Arthralgia', 'Dysgeusia', 'Fatigue', 'Headache', 'Neck pain', 'Throat tightness']",1,MODERNA,IM 926653,KS,28.0,F,"Patient received the Moderna COVID vaccine and 24 hours later her eyelids were puffy. She had also experience puffy eyelids when she had COVID. At that time, she sought medical guidance and everything else was ruled out. No itching and no watery eyes.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,,Had COVID 90 days prior and experience eyelid swelling for 6 weeks with it.,,,,"['Condition aggravated', 'Swelling of eyelid']",1,MODERNA,IM 926654,ME,56.0,F,"50 minutes after administration of the vaccine, the patient started to feel like her throat was somewhat itchy and tight. There was no wheezing or difficulty breathing. IM benadryl was administered immediately, and blood pressure taken--which was found to be elevated. Blood pressure continued to elevate further to the 180s/110s, and patient developed a ""pounding headache"" She also complained of pressure behind her eyes and ""a funny feeling in my face"" (bilateral). She was given 0.1mg of clonidine and was taken to the hospital by EMS",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,"Amlodipine, Dexilant, hydroxychloroquine, lisinopril, tizanidine",none,"htn, GERD (? indication for hydroxychloroquine)",,"lortab, potassium cultivate, red dye, aspirin, azithromycin (and others that she was unable to remember)","['Blood pressure increased', 'Facial discomfort', 'Headache', 'Ocular discomfort', 'Throat irritation', 'Throat tightness']",1,MODERNA,IM 926655,FL,59.0,F,"Dizziness, generalized weakness, and palpitations, and chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,"ESTRADIOL 0.01% VAGINAL (ESTRACE 0.01% VAGINAL) 2 GM VAGINAL DAILY CYANOCOBALAMIN (VITAMIN B-12) 1,000 MCG IM DAILY HYDROmorphone (DILAUDID) 2 MG PO Q4H PRN traMADol (ULTRAM) 50-100 MG PO Q6H PRN ENOXAPARIN (LOVENOX) 40 MG SUBQ DAIL",Unknown,Hpertension,,NKDA,"['Blood glucose', 'Chills', 'Dizziness', 'Electrocardiogram', 'Full blood count', 'Metabolic function test', 'Myocardial necrosis marker', 'Pain', 'Palpitations']",1,MODERNA,IM 926656,MD,51.0,F,"Patient reported she felt her blood pressure was going down 8 minutes after getting vaccinated. Patient complained of dizziness and palpitations. Vital signs were checked: 190/100(L) PR 121 HR was regular. RR 20 BT 98.2.. Rechecked blood pressure: 160/98(R) PR 72. Called 911 at 3pm, and the patient reached her family. Rescue squads arrived at 3:08pm. Patient sent to Shady Grove Hospital with ambulance..",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,NONE,NONE,NONE,,NONE,"['Blood pressure decreased', 'Dizziness', 'Palpitations']",1,MODERNA,IM 926658,,41.0,F,Delayed onset (9 days) injection site induration.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,01/04/2021,9.0,PVT,,,,,,['Injection site induration'],1,MODERNA,IM 926659,NY,45.0,F,Patient complained of having an itchy throat. Patient seen by Resident and examined. Vital signs stable. Patient given Benadryl for itchy throat.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,"Tree Nuts, Shellfish",['Throat irritation'],1,PFIZER\BIONTECH,IM 926660,MO,55.0,M,chills and body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,,,,,none,"['Chills', 'Pain']",1,PFIZER\BIONTECH,IM 926661,KS,57.0,F,Reported Chilling and headache for approximately 8 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,Unknown,none,none,,No known allergies,"['Chills', 'Headache']",1,MODERNA,IM 926662,MO,32.0,F,Local reaction because vaccine was given SubQ not IM,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Incorrect route of product administration', 'Local reaction']",1,MODERNA,SC 926663,CO,41.0,F,"Fever, chills, body aches, ( muscle and joint pain), pain at injection site, nausea, 1 episode of vomiting, abdominal pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Advair Allegra Ventolin Multivitamin,N/a,Asthma Allergies,,PCN Aspirin,"['Abdominal pain', 'Arthralgia', 'Chills', 'Injection site pain', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 926664,FL,38.0,F,left foot swelling and pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,none,none,"gingivitis, obesity",,none,"['Pain in extremity', 'Peripheral swelling']",2,MODERNA,SYR 926665,FL,31.0,F,Facial flushing with extension to anterior neck approximately 10 minutes status post vaccination. Mild pruritis forehead reported. Denies SOB and other symptoms. Epinephrine x 1 administered 15 minutes after vaccination left thigh. After epinephrine felt better and transported to ER via ambulance without incidence.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,MIL,None listed,Denies,Unknown,,Denies,"['Flushing', 'Pruritus', 'Tachycardia']",1,PFIZER\BIONTECH,IM 926666,PA,61.0,F,left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the same today - did register for V-safe,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,"amlodipine, propranolol",,"sinusitis, high blood pressure, osteoarthritis",,"topamax, levothyroxine","['Dizziness', 'Feeling abnormal', 'Headache', 'Hypoaesthesia', 'Peripheral coldness']",1,PFIZER\BIONTECH,IM 926667,,21.0,F,"Pt received Pfizer-COVID vaccine (under EUA) yesterday 16 Dec 2020 at approx 1700. She did not have any immediate problems after vaccination. . She woke up today feeling achy and feverish, and measured her oral temp at 1000 as 101.4 at home. She drank fluids, but took no meds -- repeat oral temp at 1200 was 99.0. . Other sxms include sore arm at vaccination site with min redness but no swelling. . She additionally reports nasal congestion and sore throat that began 1 day prior to vaccination, that she attributed to her seasonal allergies. No meds for allergies. No cough or SOB. No headache or neuro sxms. No GI sxms. . She was concerned about fever and went to drive-thru COVID testing at approx 1300... results due back in 24h. She has no known COVID contacts. . She works in sterile processing at NMCSD with no direct patient contact usually; She is on night shift now. - Fever and achy symptoms, as above, in previously healthy hospital worker, with onset approx 18h after receipt of COVID-Pfizer vaccine, dose #1. With questionable URI-like sxms one day prior to vaccination, COVID testing was very reasonable -- and results are pending now. If COVID test negative, this most likely represents mild-moderate systemic reaction to vaccine. Advised no work this evening, rest at home, increase clear fluids, and take Motrin 400mg q4-6h as needed for subjective fever or achiness -- use/precautions reviewed. Will follow-up tomorrow with this team by phone. If vaccine reaction, expect sxms to lessen rapidly and resolve over next 1-2 days. Indications for urgent care -- including marked worsening of sxms or new sxms -- reviewed. She also has number for 24/7 Immunization Support. Will file VAERS, since work missed for sxms. Will encourage enrollment in VSAFE as well. Advised that, if mild-moderate systemic reaction determined most likely source of sxms, dose #2 of COVID-Pfizer vaccine will still generally be recommended. Pt expresses understanding and appreciation of all issues.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/17/2020,1.0,MIL,Detrol,URI symptoms prior to vaccine.,"Overactive bladder, Seasonal allergies",,Latex,"['Impaired work ability', 'Injection site erythema', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive', 'Vaccination site pain']",1,PFIZER\BIONTECH,IM 926668,FL,44.0,F,Shingles outbreak with no previous history,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/06/2021,14.0,PVT,,,,,,['Herpes zoster'],1,MODERNA,IM 926669,MO,39.0,F,"Presented to ER 12/31/2020 red rash to chest, arms became splotchy, cough and shortness of breath. 25mg Benadryl and 1000mg Tylenol administered Chest x-ray completed-No acute intrathoracic process. RX for Prednisone 50mg PO daily for 5 days given",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PVT,,,,,"Aspirin, Latex, Adhesives","['Chest X-ray normal', 'Cough', 'Dyspnoea', 'Rash', 'Rash erythematous', 'Rash macular']",1,MODERNA,IM 926670,VA,33.0,F,"Moderate headache, back pain, R arm muscle soreness, moderate fatigue, loss of appetite, hot flashes/chills alernating",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,WRK,Prenatal vitamins,None,Breastfeeding,Covid vax #1,Pommelo,"['Back pain', 'Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Hot flush', 'Myalgia', 'Pain in extremity', 'Reaction to previous exposure to any vaccine']",2,PFIZER\BIONTECH,IM 926671,CO,26.0,F,"I experienced side effects from the COVID vaccine, including notable fatigue, chills/shaking, body aches for approximately 2 days. The third day I woke up without any symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,PVT,,,,,,"['Chills', 'Fatigue', 'Pain', 'Tremor']",1,PFIZER\BIONTECH,IM 926672,MO,47.0,F,"Pt phoned into clinic with complaints of severely swollen, red, itchy, tender left upper arm a week after receiving vaccination. Referred to follow-up with PCP. Pt stated she did phone MD, however was not seen in office. Pt stated, her PCP wanted her to take a picture and send; she was also instructed to elevate, ice, and take ibuprofen/antihistamine for relief. Pt arm started to improve last night with no systematic problems at this time. Following up with PCP regards continuation of vaccination series.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,PUB,"Vitamin D, Flonase, and Zyrtec",No,No,,Hives with Wellbutrin and Trazadone,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 926673,KS,30.0,M,"Tuesday- Headache, temp from 97 to 98.1. Took Tylenol. Headache didn't go away. Wednesday- temp ranged from 100.0 to 101.0 Thursday- no temperature",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Body temperature increased', 'Headache']",1,MODERNA,IM 926674,NJ,50.0,F,"at the injection site, burning at insertion site radiating down the arm, then extreme fatigue with blurry vision and my face started burning at this time took claritin ready tabs x2 . mild sob they took my BP it was over 170/90 hr was over 90 they took it every 15 min until it started lowering and the reddness and burning in my face got better and my vison cleared up and was allowed to go home. 3 hours after the shot started feeling short of breath , was on the phone with the allergist and was told to take my inhaler , albuterol 2 puffs and allegra 180mg. and had extreme fatigue and chills and body aches, took 2 tylenol and took a nap. 7hours after the shot all symptoms had resolved except for the arm site pain and a mild headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,allegra 360mg po,none,allergies,,"fragrances, cipro , cat scan injectable dye","['Burning sensation', 'Chills', 'Dyspnoea', 'Erythema', 'Fatigue', 'Headache', 'Injection site pain', 'Pain', 'Vision blurred']",1,MODERNA,IM 926675,AZ,24.0,F,"Pfizer-BioNTech COVID-19 VACCINE EUA; Throat swelling/closing up; SOB, dizziness 15 min post injection; lasting about 5 min but dizziness remains",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"nalocone nasal prn, prenatal vitamin, senokot S",,,,penicillins,"['Dizziness', 'Dyspnoea', 'Pharyngeal swelling']",1,PFIZER\BIONTECH,IM 926676,MN,42.0,F,"Started with a head ache and sore arm last night. Today she has a strong headache, her arm hurts, is achy, and is having intolerable hip pain. Is taking ibuprofen for comfort.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,Citalopram and ibuprofen.,none,none,,none,"['Arthralgia', 'Headache', 'Pain', 'Pain in extremity']",7+,MODERNA,IM 926677,KS,39.0,F,Large raised bump under skin at injection site. The area is about 2 inches in diameter and hot to touch. the raised bump is itchy and slightly tender,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PUB,Damphetamine 20mg ibuprofen 200mg,asthma,asthma,,"penicillin, sulfa and ceftin","['Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,MODERNA,SYR 926678,AL,48.0,F,"numbness left arm to elbow and left upper cheek, denies shortness of breath, denies itching, no rash noted, Initially refused Benadryl po instead requested to stay for observation for an additional 15minutes. Symptoms persisted, denies shortness of breath, ithcing, denies swelling of tongue, At 1500 Benadryl 25mg given po, patient stayed for observation for 15 minutes and was ready to leave at that time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,['Hypoaesthesia'],UNK,PFIZER\BIONTECH,IM 926679,OH,26.0,F,"Fever, diaphoretic, full body muscle aches, swollen and painful lymph nodes in the right side of the neck, muscle pain at the injections site in right arm, metallic taste in mouth, fatigue, headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,WRK,None,Positive COVID test on 12/16/2020,None,,None,"['Dysgeusia', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Lymph node pain', 'Lymphadenopathy', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 926680,,38.0,F,"EE reports, HA and body aches that improved with Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,,,,,,['Pain'],UNK,PFIZER\BIONTECH, 926681,SD,39.0,M,Swelling under my armpit.....black and blue....tender to touch...noticeably different than my right armpit in terms of swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,PVT,"baby aspirin, vitamin D3, and Zinc - taken since early November when I got COVID Meloxicam - 1mg tablet - take 1 tablet 1 time per day - started on Dec. 29th",,,,penicillin and bee stings,"['Contusion', 'Lymphadenopathy', 'Tenderness']",1,PFIZER\BIONTECH,SYR 926682,NV,37.0,F,"On 01/06/21 increased ""pounding"" heart rate started within minutes of vaccine administration. 01/06 at 08:03 am: BP= 143/86, HR= 72, O2 sats= 96% RA; at 08:12 am: BP= 130/83, HR= 68, O2 sats= 97% RA; at 08:20 am: BP= 141/80, HR= 61, O2 sats= 96% RA; 08:30 am: BP= 129/83, HR= 68, O2 sats= 97% RA",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,NuvaRing,None,None,COVID-19 Pfizer,NKDA,"['Heart rate increased', 'Palpitations']",2,PFIZER\BIONTECH,IM 926683,,68.0,F,Dealyed (7-8 days) appearance of rash on left hand followed by rash on both arms and legs.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/31/2020,7.0,PVT,,,,,,['Rash'],1,MODERNA,IM 926684,NY,45.0,F,"tachycardia, palpitations, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Albuterol, Pepcid, Ellipta, Nulev, Prevacid, Vit D",,"GERD, Anxiety",Flu Vaccine last year with palpitations,"Amoxicillin,","['Chest X-ray', 'Electrocardiogram', 'Full blood count', 'Metabolic function test', 'Nausea', 'Palpitations', 'Tachycardia', 'Troponin']",1,MODERNA,IM 926685,MA,56.0,F,rash on my upper thighs; left more inflamed than the right. Eventually went away. Ittchy.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/20/2020,2.0,PVT,"Keppra, prozac, norvasc, vitamin D, vitamin C, tumeric",,"hypertension, depression, obesity",,Dilantin-entire body hives,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 926686,IL,49.0,F,Pt developed cellulitis near the injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,Singulair,None,Diabetes,,"Bees, coconut, latex",['Injection site cellulitis'],UNK,MODERNA,IM 926687,NM,52.0,F,"The day of injection/shot I had a low grade fever, shot location was hot to the touch, red and had little red spots and I had a headache. A few days later I felt like I was getting a cold and very sleepy. I took some cold meds for 3 days and cold symptoms went away. The only thing that has not gone away is the sleepiness. All I want to do is sleep and if I don't get any sleep I get a headache. I do a few things when I get up then I have to go take a nap, get up do some more and go take a nap. and I can sleep all night long.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,PHM,"omeprazole, Zetz, Clonazepan, Lisinopril, Simvastatin, Motoprolol, Vitamin D, Potassium",none,"History of Leukemia, in remission for 35 years. Week heart,",,"Vicodin, Latex, Kiwi, all Melons, Avocados,","['Headache', 'Injection site erythema', 'Injection site rash', 'Injection site warmth', 'Pyrexia', 'Somnolence']",1,MODERNA,SYR 926688,PA,32.0,F,Tachycardia to ~110 bpm baseline mid 80 HX of POTS,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,,,,,,['Tachycardia'],1,PFIZER\BIONTECH,IM 926689,TX,27.0,F,"15 minutes after administration: began experiencing light headedness, nausea, and tightness in chest 1 hour after administration: began experiencing tightness in throat, irregular heart beat, and hypertension, anxiety/feeling of impending doom",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,UNK,Microgestin Fe 20,Ear infection 2 weeks prior,,,Acai berry,"['Anxiety', 'Chest discomfort', 'Dizziness', 'Heart rate irregular', 'Hypertension', 'Nausea', 'Throat tightness']",2,PFIZER\BIONTECH,IM 926690,NY,30.0,F,"Chills, myalgias, rash to chest and ear that is pruritic (started day after the vaccine and continued to day 3 post vaccine). No signs of anaphylaxis.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,None,None,None,,Amoxicillin,"['Chills', 'Myalgia', 'Rash', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 926691,TX,43.0,F,"CHILLS,FEVER,LOTS OF PAIN ON LEFT ARM ,SWOLLEN ARM",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,none,none,none,,,"['Chills', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 926693,CO,52.0,F,"Nauseous, lightheaded, Itching at injection site, red, swollen, hot, lump like ""a plum"" painful to touch ""down to elbow""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Metformin, Atorvastatin, Lantus, Enbrel",No,"Diabetes, Rheumatoid Arthritis",,"Sulfa (sick to stomach immediately), shellfish (facial swelling), Bees (extreme swelling at site of sting)","['Dizziness', 'Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Nausea']",1,MODERNA,IM 926694,CA,44.0,F,Patient stated she had an elevated heart rate and suffers from anxiety/panic attacks. She stated she had not taken her Ativan today. HR was 133 and lowered to 78 after sitting in a chair with legs elevated on another chair. Pt was in a talkative mood and showed no outward signs of distress. She was reassured and after 30 min pt stated she felt well enough to leave.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,Unknown,unknown,Anxiety/panic attacks,,No known allergies,"['Heart rate increased', 'Logorrhoea']",1,MODERNA,IM 926695,,50.0,F,"Facial and chest redness b/p180/90 Heart rate 97 pso2 98% Reported some itching released at 2:19 redness continues for further report of itching. b/p 142/78 heart rate 86 pso2 97% Respirations even and unlabored, skin pink warm and dry. Patient stated she was ready to go home. Informed to seek medical attention for further problems.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,"['Erythema', 'Pruritus']",1,MODERNA,IM 926696,VT,54.0,F,arm became swollen and also had hives. The hives and swelling got worse throughout the day with some throbbing. The day after the injection I could barely lift my arm. I also has an extremely stiff neck to where it was difficult to move it. This was a day or so after the injection to right about a week or so after. Also a very bad headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,01/04/2021,13.0,PVT,"Tramadol, Topamax, Zofran, Vistaril, Norvasc, Inderal, Indocin, Candesartan, Nurtec, Namenda, Pepcid, Lipitor, Tizanidine, Synthroid, wellbutrin XL, Doc-Q-Lace, Ativan, Miralax,","migraines, colitis","migraines, colitis, degenerating disc in back",,"Codeine, Midodrine, Adhesive Tape, Prednisone, Hymenoptera Allergenic Extract","['Headache', 'Mobility decreased', 'Musculoskeletal stiffness', 'Pain', 'Peripheral swelling', 'Urticaria']",1,MODERNA,IM 926697,PA,42.0,F,Large welt with erythema; cannot lift arm due to pain,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Erythema', 'Mobility decreased', 'Pain', 'Urticaria']",1,MODERNA,IM 926698,CA,42.0,F,"Body aches, chills, nausea, swollen glands and heart palpitations.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Zyrtec, Iron, Vitamin D, and prilosec",,,,,"['Chills', 'Lymphadenopathy', 'Nausea', 'Pain', 'Palpitations']",UNK,MODERNA,SYR 926699,AZ,29.0,F,FATIGUE,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,,,,,,['Fatigue'],1,MODERNA,SYR 926700,CO,41.0,F,Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine until about 3pm. Just typical arm pain. Moderate/Severe Fatigue set in around 3-6pm. Needed to nap from 4-5pm (extremely unsusual). Felt fine the next day. Moderate congestion in ears starting around the same time (6 hours after) and is persisting 30 hrs later. Feel like my ears will not pop and trying to yawn a lot. Also felt pretty bad sinus congestion starting at 7pm 12/21 (10 hrs after vaccine). Could not breathe through nostrils. Treated with sinus rinse and sudafed.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/21/2020,0.0,PVT,,,,,,"['Ear congestion', 'Ear discomfort', 'Fatigue', 'Feeling abnormal', 'Nasal congestion', 'Pain in extremity', 'Sinus congestion']",1,PFIZER\BIONTECH,IM 926701,MO,57.0,M,"severe pain, swelling to injection site that turned into cellulitis causing need for antibiotic treatment",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,SEN,AS ORDERED BY PHYSICIAN,"SEVERE PVD, OBESITY",SEVERE PVD,,NKDA,"['Cellulitis', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 926702,CA,39.0,F,"Fatigue, irritability, difficulty concentrating. Nausea around 8pm. Soreness at injection site 9pm. Body aches. Woke up around 1pm itchy, took allergy pill. Soreness in arm increased. Extreme fatigue, slept until 1pm. Headache, fatigue, sore arm, body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Adderall, ibuprofen",None. Haven?t been sick for years.,No,,Keflex,"['Disturbance in attention', 'Fatigue', 'Headache', 'Injection site pain', 'Irritability', 'Nausea', 'Pain', 'Pain in extremity', 'Pruritus']",1,MODERNA,IM 926703,OK,35.0,M,"Guillain Barre syndrome/AIDP event. Paresthesia and nerve pain developed in bilateral legs 4 hours after shot and progressed slowly for 4 days in intensity and area involved. Symptoms progressed distally to superior. On the 5th day symptoms progressed rapidly and involved bilateral legs up to the groin, left arm up to lateral shoulder, and right hand. I went to the hospital and was admitted to start IVIG treatment for Guillain Barre Syndrome/AIDP.",Not Reported,,Yes,Yes,2.0,Yes,N,12/29/2020,12/29/2020,0.0,PUB,None,None,Bradycardia at rest. History of Guillain Barre Syndrome/AIDP in 2010.,,None,"['Blood test', 'Guillain-Barre syndrome', 'Immunoglobulin therapy', 'Magnetic resonance imaging', 'Neuralgia', 'Neurological examination', 'Paraesthesia']",1,MODERNA,IM 926704,NY,48.0,F,"Itchy throat & hotness in eyes. Rapid Response Team called. Benadryl given, Patient returned to work after 1 hr.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"mirtazepiine, Vit D3, Motegrity",Constipation,,,Surgilube rash,"['Abnormal sensation in eye', 'Throat irritation']",1,MODERNA,IM 926705,FL,64.0,F,"Left arm pain and decreased ROM onset same day as vaccination 12/28 and improved over the next few days. 12/30 patient with improved symptoms and 1/4 patient reported all symptoms resolved. 01/06, patient reports reccurance left arm pain, advised to come to company care for evaluation. Treatments and outcomes ongoing at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,"Synthroid, Cartia XL, Enalapril, Eliquis",none,"thyroidectomy, a.fib, htn",,NKA,"['Injected limb mobility decreased', 'Pain in extremity']",1,MODERNA,SYR 926706,CT,29.0,F,"sneezing, itchy throat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Copper IUD,,,,"aspirin, naproxen","['Sneezing', 'Throat irritation']",1,MODERNA,IM 926707,PA,60.0,F,Single raised bump at inject site - no redness or pain,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/07/2021,9.0,PVT,,,,,,['Injection site swelling'],1,PFIZER\BIONTECH,IM 926708,,45.0,F,"Delayed onset (8 days) injection site induration and itching along with joint pain and myalgias, Resolved 3 days later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/01/2021,8.0,PVT,,,,,,"['Arthralgia', 'Injection site induration', 'Injection site pruritus', 'Myalgia']",1,MODERNA,IM 926709,NY,43.0,M,"12/17/2020 Vaccine L shoulder. 12/18 muscle aches, feverish, fatigue. @ night because itchy location on back; reddish and inflamed. 12/19 morning ecstatic 12/20 numbness on penis 12/21 lesions on gland penis; spots pigmented Referred to dermatology; prescribed topical steroid cream. Lesion numbness and itching subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/18/2020,1.0,PVT,,Lesion on lower buttocks; biopsied; lichen planus (diagnosed after vaccination),,,,"['Biopsy skin abnormal', 'Erythema', 'Fatigue', 'Genital hypoaesthesia', 'Lichen planus', 'Myalgia', 'Pigmentation disorder', 'Pruritus', 'Pyrexia', 'Skin lesion']",1,PFIZER\BIONTECH,SYR 926710,CA,54.0,M,"Four days after receiving the vaccine - developed flu like symptoms: headache, temperature, body aches, chills. Following day developed pain and swelling in left armpit. Two days after that a large red welt developed on left deltoid (site of injection).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,PVT,None,None,Arthritis,,None known,"['Axillary pain', 'Body temperature increased', 'Chills', 'Headache', 'Influenza like illness', 'Injection site erythema', 'Injection site urticaria', 'Oedema peripheral', 'Pain', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 926712,NY,55.0,F,"Patient' bilateral hands itchy, red, and swollen Benadryl 25mg po at 16:15 Prednisone 40mg po at 16:42",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Lisinopril, Lipitor, Co Q10, Vitamin D3, Multivitamin, Omega 3",none,"Hypertension, Hyperlipidemia",,none,"['Erythema', 'Peripheral swelling', 'Pruritus']",1,MODERNA,IM 926715,NY,35.0,F,"Immediately following shot, I had soreness in my arm that gradually worsened throughout the day. Around 8 pm the pain radiated up my shoulder across the top of my back. Around 10 pm I was suddenly hit with a wave of fatigue where my husband was unable to wake me from the couch to go to bed. I woke up around 8:30 am on 1/7/21 with a debilitating headache, tingling in my fingertips, and unsteadiness while walking. I was advised to go to the ED who gave no treatment other than recommending OTC pain meds, benedryl and rest. I returned home and took all the recommendations. At 4:41 pm, there has been no change with symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Labetolol Hydrochlorothyazide Amlodipine Lexapro Probiotic Omeprazole,None,High blood pressure Melanoma,,Adhesives and contrast dye,"['Arthralgia', 'Asthenia', 'Back pain', 'Balance disorder', 'Fatigue', 'Headache', 'Immediate post-injection reaction', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Somnolence']",1,MODERNA,IM 926716,CO,33.0,F,"I received the vaccine on 12/18. Sore arm the next day (as expected), but then 2 days later, on 12/21 & 12/22 I was SUPER tired in the afternoon/evening. Seems better 12/23. Felt totally fine otherwise, but definitely had significant fatigue that is not normal for me at all. I still plan to get the 2nd dose as scheduled.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,,,,,,"['Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 926717,RI,29.0,F,"5 hours after injection patient had sudden onset difficulty speaking, nausea and vomiting, and sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Adderall,,,,,"['Aphasia', 'Full blood count', 'Human chorionic gonadotropin', 'Metabolic function test', 'Nausea', 'Oropharyngeal pain', 'Vomiting']",2,PFIZER\BIONTECH,IM 926718,CT,27.0,F,"I received my vaccine in the left arm on January 4, 2021 around 2:20P.M. On January 6, 2021 around 4:30PM I noticed a rash that itched on my right arm. The rash consisted of small pimple like clusters along the length of my arm. On January 7, 2021 the same rash appeared on both my left and right arm and continued to itch. Prior to the rash there was some tenderness in the left arm at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,PVT,IUD,Migraine disorder. Costochondritis,,,None,"['Dermatitis acneiform', 'Injection site pain', 'Laboratory test', 'Rash', 'Rash pruritic']",1,MODERNA,SYR 926719,CA,50.0,F,"Numbness and tingling in fingers and arm. It has slowly gone away but is still lingering. Cognitive impaired, dizzy, disoriented",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,UNK,,,,,,"['Cognitive disorder', 'Disorientation', 'Dizziness', 'Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,SYR 926720,CO,29.0,F,Injection site is red after going back to normal skin color and it has been itchy and hot to touch,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/07/2021,9.0,PVT,"Glimeperide Januvia Vitamin C Equate Allergy Relief Biotin Gabapentin Montulekast Calcim, Magnesium and Zinc Sertraline Trazodone",,Type 2 Diabetic,,Lilly Flowers Mustard Clindamycin,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",2,MODERNA,IM 926721,TX,52.0,F,"Patient with low grade fever (tmax 99.6), body aches, and pain at injection site. Taking motrin with some relief.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,,,,Rash at injection site 9 days after receiving 1st dose of the COVID vaccine.,,"['Injection site pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 926722,NY,50.0,F,"Patient at around 14 minutes post vaccine became very hot, developed rash to upper chest/neck going up left side of neck and began to itch. She stated she had atrial tachycardia and didn't want epinephrine. She was given Benadryl 50mg/ml IM right gluteus maximus lot #80010 exp 8/2022. vitals were 130/86 88 20 before benadryl at 1920. icepacks provided, after 10 minutes started feeling better, she was discharged at 2000 and dc vitals were 124/82 72 18, redness/rash resolving. She called her primary care provider, Dr. during this time who advised to take benadryl at 2300 and if any symptoms returned or worsened to go to emergency room by EMS.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,Unknown,After the vaccine she stated that she has atrial tachycardia,Unknown,,"After the vaccine she did share that she did have allergies to medications, including the flu vaccine, she did not disclose before the vaccine","['Erythema', 'Feeling hot', 'Pruritus', 'Rash']",1,MODERNA,IM 926723,OR,37.0,F,I suffered from a miscarriage. 12 weeks along. It had been a healthy pregnancy otherwise.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/25/2020,6.0,WRK,Over the counter,,,,,"['Abortion spontaneous', 'Ultrasound scan']",1,PFIZER\BIONTECH,IM 926724,,50.0,U,"Delayed (7 days) injection site erythema, swelling and diagnosed as cellulitis. Treated with Doxycycline.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,01/02/2021,9.0,PVT,,,,,,"['Injection site cellulitis', 'Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 926725,IN,25.0,F,"Severe nausea, sluggishness, body aches, headaches, cold and hot flashes, swollen injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Birth control,,,,,"['Headache', 'Hot flush', 'Injection site swelling', 'Nausea', 'Pain', 'Sluggishness']",UNK,MODERNA, 926726,OH,28.0,F,Estimated due date: 03/05/2021 All I had really was exhaustion and I had to go lay down. I probably took an hour nap and it felt better. I still felt sluggish but a little better. There is no way I could have worked that day the way I was feeling.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,prenatal vitamins,none,asthma,,none,"['Exposure during pregnancy', 'Fatigue', 'Impaired work ability', 'Sluggishness']",1,PFIZER\BIONTECH,SYR 926728,NY,43.0,M,"1/5/2021 vaccination. Similar to first vaccine reaction. 'Worst body chills'. Seven hours; feverish. Tylenol, Advil. 1/6 morning - feverish, body aches No new lesions",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/18/2020,1.0,PVT,,Lesion on lower buttocks; biopsied; lichen planus (diagnosed after vaccination),,,,"['Chills', 'Lichen planus', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 926729,VT,52.0,F,"Approximately 10 minutes after receiving vaccine patient complaint of itchy eyes and hands. Upon review, patient eyes red and swollen, palms of hands red and sweaty, chest rashy, ears red. Injection site WNL.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Sertraline 200mg daily, atorvastatin 10mg daily, bupropion sr 100mg daily, naproxen dr 500mg bid,.",,"depression, anxiety, hypercholesterolemia",,"anaphylaxis to bees, hives with coconut","['Erythema', 'Eye pruritus', 'Eye swelling', 'Hyperhidrosis', 'Ocular hyperaemia', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 926730,,49.0,F,"Client emailed back and reported that after she left she had itching, flushing and cough. Reported that she took benadryl and it resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,"['Cough', 'Flushing', 'Pruritus']",UNK,MODERNA,IM 926731,KS,41.0,F,I experienced extreme pain to my left arm but not at the injection site. I experienced swelling and redness to my left arm with a hot sensation upon palpation. My pain got so bad that I had to ice it.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,WRK,Participant did not want to mention.,No,High Blood Pressure,,"Penicillin, Keflex","['Erythema', 'Pain in extremity', 'Peripheral swelling', 'Skin warm']",1,MODERNA, 926732,,24.0,F,"Sore arm with it 2 hours of the vaccine administration second dose, fatigue onset 4 hours after vaccination second dose , lightheadedness and nausea onset 5 hours post administration second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,WRK,,Seasonal allergies,Interstitial cystitis,,"Capsaicin, codiene, figs","['Dizziness', 'Fatigue', 'Nausea', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 926733,MN,33.0,F,"Vaccine received at 3:00 PM on 1/4/2021 10:00 PM: fatigue 1/5/2021: 01:45 AM: Fever 104 F, Chills, Body aches, headache, severe pain in arm of injection. 04:00 AM: Fever 101 F 08:00 AM: Fever 100.4 F. Tylenol taken. Headache and body aches throughout the day. 1/6/2021: headache and body aches most of the day ALL Symptoms gone by 48 hours post vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,none,none,none,,none,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 926734,IN,53.0,F,Bells Palsy?left facial droop and left facial numb/tingling,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/07/2021,15.0,PVT,"Montelukast, Effexor XR, Premarin, Metoprolol, Allegra",None,"Migraines, Allergies, venous insufficiency",,Penicillin,"['Facial paralysis', 'Hypoaesthesia', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 926735,OH,78.0,F,"DECEMBER 30 2020 BUMP , SWEELING AND ITCHING AT INJECTION SITE AND HALF DOWN MY ARM. USE SARNA AND FELT BETTER IN ABOUT A DAY JANUARY 4TH 2021 SWELLING AND INTENSE ITCHING ON MY RIGHT ARM AND CHEST ACCOMPANIED BY A RED RASH. USED SARNA AND ICE PACK. FELT BETTER AFTER A DAY OR TWO.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,PUB,ELQUIS CITALAMPRAM LOSARTAN CARDIZEM XANAX,NONE,HIGH BLOOD PRESSURE AFIB,,PENICILLIN,"['Abdominal distension', 'Injection site pruritus', 'Injection site swelling', 'Peripheral swelling', 'Pruritus', 'Rash erythematous']",1,MODERNA,IM 926736,MO,34.0,F,"1) fever/chills/feverish ~96 h 2) severe myalgia ~36h 3) Chest Pain ~1-2 h 4) SOA ~24 h 5) Altered taste ~12h 6) No appetite ~48h 7) Fatigue (couldn't stay out of bed) ~24h 8) Nausea, intermittent ~24h 9) Brain fog ~6h 10) Nasal congestion ~72h 11) Full body COVID like rash with itching on 1/2 ~36h 12) Arm sore/stiff (severe) ~24h 13) Vasovagal episode ~10min",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Mvi Elderberry Magnesium sulfate Vitamin D,COVID 11/14/20,None,,Amoxicillin,"['Chest pain', 'Chills', 'Decreased appetite', 'Fatigue', 'Feeling abnormal', 'Hypersomnia', 'Musculoskeletal stiffness', 'Myalgia', 'Nasal congestion', 'Nausea', 'Pain in extremity', 'Pruritus', 'Pyrexia', 'Rash', 'Syncope', 'Taste disorder']",1,PFIZER\BIONTECH,IM 926738,OH,45.0,F,Anaphylaxis - throat itching and Shortness of breath,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,Unknown,Unknown,Unknown,,Potential allergies from multiple sources,"['Anaphylactic reaction', 'Dyspnoea', 'Throat irritation']",7+,MODERNA,IM 926739,NC,32.0,F,"Severe, SEVERE flu like symptoms which nearly prompted a trip to the emergency room. I could not change my own clothes my myalgias and joint pain were so severe. I was sobbing in my kitchen and my fianc� had to help me move around the house. I was slowing my speech and mentation. Severe headache. I made my fianc� wake me up every two hours to make sure I wasn?t decompensating.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,"Xiidra, DayQuil day of vaccination bc I had a head cold, and norethindrone",I had a head cold at the time of the vaccine. It was not COVID I had a negative PCR covid test that morning,Endometriosis,,None,"['Arthralgia', 'Crying', 'Headache', 'Influenza like illness', 'Loss of personal independence in daily activities', 'Mental impairment', 'Myalgia', 'SARS-CoV-2 test negative', 'Slow speech']",1,PFIZER\BIONTECH,IM 926740,WA,32.0,F,12/29-12/31--Left arm pain from injection. Arm pain subsided and was no longer an issue. 1/6- Injection site began to hurt again and minor swelling. A rash occurred later that night. 1/7-rash is now bigger around the injection site. Itching tenderness continues to worsens throughout the day.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,PVT,"Levothyroxine, Prenatals, Vit D, iron, Fiber",No illness,Hypothyroid,,clindamycin,"['Injection site pain', 'Injection site rash', 'Injection site swelling', 'Pain in extremity', 'Pruritus', 'Tenderness']",1,MODERNA,SYR 926741,NY,56.0,F,"burning rash /hives on back of head treatment zertec . less red ,less burning after 1 hour .",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,WRK,"dulera,tordoza singular","asthma , hashimotos ,fibromyalgia","asthma ,hashimotos ,fibromyalgia , tiatian medal from acdf",,allergic to bee venium,"['Burning sensation', 'Rash', 'Urticaria']",UNK,MODERNA,IM 926742,WI,31.0,F,"Redness, swelling, burning/pain, war to the touch, increasing 72 hours after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,,COVID-19 on 11/30,,,,"['Burning sensation', 'Erythema', 'Pain', 'Skin warm', 'Swelling']",UNK,MODERNA, 926743,WA,43.0,F,"Immediate flushing of skin, tachycardia, impaired cognition",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,none,none,none,,none,"['Breath sounds normal', 'Cognitive disorder', 'Electrocardiogram', 'Flushing', 'Immediate post-injection reaction', 'Tachycardia']",2,PFIZER\BIONTECH,IM 926744,MO,53.0,F,Chilling and body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,,,,,"AMOXICILLIN, AMPICILLIN, PENICILLIN","['Chills', 'Pain']",1,PFIZER\BIONTECH,IM 926745,IL,46.0,M,"5 days after vaccine dose, began with COVID-like symptoms. Fever (101�), fatigue, body aches, headache, and skin burning sensation. Had a rapid COVID test today, which was negative, but symptoms still persist after 2 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,PHM,"Sertraline, protonix",None,None,,NKA,"['Fatigue', 'Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test', 'SARS-CoV-2 test negative', 'Skin burning sensation']",1,PFIZER\BIONTECH,IM 926746,TX,33.0,F,"Patient presented for covid 19 vaccine 1/7/2021. Vaccine given at 11:11 AM. Patient asked to wait 30 min. after injection due policy in place. At 11:14AM patient states ""is it hot in here, I feel dizzy"" Patient assisted to the floor, legs elevated. That is when patient began to shake. BP 142/78 O2 94 Pulse 111. Patient was responsive but unable to open eyes and answer questions, nodding appropriately to questions given by Provider on staff. Provider called to scene. Provider assessed patient, stridor noticed by Provider and 0.3mg of Epi given by IM. EMS was called to clinic. At 11:19AM BP 142/78. EMS arrived at 11:23AM and stayed with patient, no change in status. EMS took patient to hospital. Patient discharged same day and per patient ""doing well other than sore and tired"".",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,No,,,,"['Dizziness', 'Eyelid function disorder', 'Fatigue', 'Feeling hot', 'Pain', 'Stridor', 'Tremor']",1,MODERNA,IM 926747,NC,55.0,F,"Sore arm next day. Then on Jan 1 arm was red and inflamed and tight. Got vaccine on 12/30/20. Took ibuprofen and Tylenol. By Sunday 1/3/21 swelling was down, not red, only a little bump there. Then on 1/6/21 it was itchy, red circle, warm, inflamed and sore. On 1/7/21 arm is even worse.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,WRK,"Zyrtec, omeprazole, sprintec, melatonin, ambien, atenolol",none,"dysmenorrhea, insomnia",,none,"['Erythema', 'Inflammation', 'Pain', 'Pain in extremity', 'Pruritus', 'Skin tightness', 'Skin warm', 'Swelling']",1,MODERNA,IM 926748,NV,14.0,M,Medication Error - 0.5 mgs of Moderna Vaccination administered to person less than 18 years old (14 year old patient). No Symptoms or complaints. Parent contacted - advised to watch for any untoward signs or symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,unknown,unknown,unknown,,unknown,['Product administered to patient of inappropriate age'],1,MODERNA,IM 926749,ME,35.0,M,"Received first dose of Moderna on 1/1, felt hot flashes, tachycardia and dizzy after 30 seconds but did not inform nurses. Felt better during the 15 minute waiting period but 10 minutes after felt bad. 1 hour after vaccine had an allergic reaction similar to his shellfish allergy: pale, tachycardia, itchy face, dizzy with blackspots and took Benadryl. Denies SOB and airway closing. Denies any reactions to other vaccine. Next dose scheduled for 1/29. As per CDC recommendations, he may get the 2nd dose of vaccine but will advise to stay for at least 30 minutes to monitor for symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,,,,,shellfish,"['Dizziness', 'Hot flush', 'Pallor', 'Pruritus', 'Tachycardia']",1,MODERNA,IM 926750,ID,56.0,F,Started feeling hot and flushed less than 24 hours after injection. No fever. Have been having 4-5 episodes throughout the day since. No treatment needed. I just wanted to report just in case .,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PVT,None,None,None,,None,"['Feeling hot', 'Flushing']",1,PFIZER\BIONTECH,IM 926751,CA,52.0,F,"day 3 post vaccine - left axilla pain/swelling. day 4 post vaccine - left axilla pain/swelling and chest/left breast swelling, tenderness day 5 post vaccine - left axilla pain/swelling and chest/left breast swelling, tenderness notified doctor - started motrin 400mg three times/day day 6 post vaccine - left axilla pain/swelling (swelling is much less in chest/breast) day 7 post vaccine - left axilla musch less pain/swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/03/2021,3.0,PVT,Levothroid and Metformin,,hyperlipidemia,,,"['Axillary pain', 'Breast swelling', 'Breast tenderness', 'Oedema peripheral']",UNK,MODERNA,IM 926752,OR,42.0,F,"Modern a COVID-19 Vaccine EUA Nausea, headache, body aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PUB,"Multivitamin, probiotics",None,None,,"Lamacil, artificial cinnamon","['Fatigue', 'Headache', 'Nausea', 'Pain']",UNK,MODERNA, 926753,IL,23.0,F,body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,ibuprofen,no,none,,no,['Pain'],1,MODERNA,IM 926754,NV,31.0,F,"Myalgias, headache, chills, low grade fever, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,UNK,Oral contraceptive,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 926755,NM,70.0,F,"Vaccine Candidate received vaccine approxat 2:30pm, was monitored for 15 min no complications at the time, went home. Around 5:30pm while walking into her home she became unresponsive, was assisted in a siting position, became incoherent, mumbling and started to convulse to the right side of her r upper extremity. Foaming at the mouth and stopped breathing, CPR was initiated for 1-2 min, EMS arrived was transported to Medical Center. She was admitted and is currently hospitalized. MD reports this event is highly unlikely related to the vaccine given her medical history but suggested to report being its a new vaccine. Current status: stable.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"warfarin, lisinopril, atenolol, Lasix, potassium, Tylenol","rheumatic heart disease, hx of stroke, brain hemorrhage, open heart X3 with valve replacement, VP shunt","rheumatic heart disease, hx of stroke, brain hemorrhage, open heart X3 with valve replacement, VP shunt",,codeine,"['Computerised tomogram', 'Electroencephalogram', 'Foaming at mouth', 'Incoherent', 'Laboratory test', 'Magnetic resonance imaging', 'Respiratory arrest', 'Resuscitation', 'Seizure', 'Speech disorder', 'Unresponsive to stimuli']",1,MODERNA,IM 926756,ID,56.0,F,"In less than 24 hours following the immunization, feeling of ""flush"" and ""warm inside"" without fever. Probably 6-8 times per day lasting greater than 30 min. This ""warmth"" or ""flush"" feeling continues to this day. I am peri-menopausal, but have not had ""hot flashes"" prior to the administration of the COVID immunization.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,none,none,none,,none,"['Feeling hot', 'Hot flush']",1,PFIZER\BIONTECH,IM 926757,,,U,"Left arm not just sore like usual after some vaccines. Could barely lift my arm and was sore all the way to the elbow. Soreness started about 8 hrs after the injection. Other side effects not unusual, just chills (without fever), aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Chills', 'Fatigue', 'Injection site pain', 'Mobility decreased', 'Pain']",2,PFIZER\BIONTECH,SYR 926758,NY,46.0,F,5 minutes after receiving vaccine pt felt flushed and had palpitations and trouble breathing. They hooked her up to a monitor. Rhythm was sinus tach with HR 130. O2 was 99%. Episode lasted 7 minutes and then symptoms completely resolved. She feels fine since then.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,none,none,none,,shellfish - lip swelling,"['Dyspnoea', 'Flushing', 'Palpitations', 'Sinus tachycardia']",1,MODERNA,IM 926760,AL,46.0,F,"Redness, tenderness and pain at the injection site with significant swelling. Tylenol was taken upon the onset of swelling and pain. Advised to apply hot compress to the site overnight and will check again in the morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,MIL,None,None,None,,None,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 926761,AZ,26.0,F,Sob that was better after taking off mask- EMT on sight see documents scanned into chart,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,['Dyspnoea'],UNK,PFIZER\BIONTECH,IM 926762,TX,36.0,F,Started a low grade fever not over 102. Red and swollen at the injection. Took Benadryl and put ice on it because the redness kept getting larger. The redness went away but then came back. Took Benadryl and iced it and the redness went away.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/02/2021,2.0,PHM,"Singulair, Vitamins",no,Arthritis,,no,"['Injection site erythema', 'Injection site swelling', 'Pyrexia']",1,MODERNA,IM 926763,MD,30.0,F,"SORE THROAT, LIGHT HEADINESS; TREATMENT: GAVE 25MG OF DIPHENHYDRAMINE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,MIL,,,,,,"['Dizziness', 'Oropharyngeal pain']",1,PFIZER\BIONTECH,IM 926764,OH,54.0,F,PATIENT WAS ADMINISTERED 1ML INSTEAD OF 0.5ML DOSE. NO S/SX OF ADVERSE REACTIONS.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'No adverse event']",1,MODERNA,IM 926765,IN,25.0,F,"upper arm where i got the shot began to swell intensely. injection site was hot and painful to the touch. swelled up to about the size of a mandarin orange. swelling went down on day three, however a week and a half later i still have a red circle about the size of a US half dollar coin.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,PVT,Zoloft and Lamictal.,none,none,,none,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Oedema peripheral']",1,MODERNA,IM 926766,IA,52.0,F,"constant ringing in ears since vaccine, softer and high pitched, it is constant at a softer level and then increases to higher and louder. no dizziness, lightheadedness, nausea, visual disturbances, numbness or tingling - it is just the ringing.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,"multivitamin, iron",none,,,none,['Tinnitus'],1,PFIZER\BIONTECH,IM 926767,OR,35.0,F,"Was taken to ED on 12/21 from vaccine clinic with throat tightness, generalized itching, facial swelling. Received Epi injection x 1. benadryl, pepcid and Dexamethasone, was stable and sent home. On 12/22 back to ED for recurrent itching, tightness in throat, and face fullness. Pt was stable, advised to continue Pepcid and Benadryl, and given rx for Medrol dose pack to have available prn if symptoms worsened.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,WRK,Unk,Unk,Unk,,Unk,"['Pruritus', 'Swelling face', 'Throat tightness']",1,PFIZER\BIONTECH,IM 926768,CA,41.0,F,"Hives, fatigue, and fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Nortriptyline, Amlodipine, multivitamins, vitamin d3",none,hypertension,,"iodine, shellfish","['Fatigue', 'Pyrexia', 'Urticaria']",1,PFIZER\BIONTECH,IM 926769,CA,42.0,M,"Pimples around face, on forehead, in random spots, around chest/breast area soreness in arm around the injection area fogginess shaky on the inside for 40 minutes",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/07/2021,2.0,UNK,,,,,,"['Acne', 'Feeling abnormal', 'Injection site pain', 'Nervousness']",1,MODERNA,SYR 926770,AL,30.0,F,When patient presented to get immunization she reported previous mild reaction of hives with flu immunization. She reported prior to receiving her flu immunization she would take 50mg diphenhydramine. We had her take 50mg diphenhydramine & then wait 30 minutes prior to receiving the first COVID-19 dose. After receiving the vaccine we had her stay in the room directly in front of us for 30 minutes so we could monitor her. It was noted she seemed to be having difficulty breathing & at that point we administered the first epinephrine 0.3mg dose. She reported feeling better & her color got better. We continued to closely monitor her & in approximately 7 to 8 minutes her breathing became labored again. A second epinephrine 0.3mg dose was administered & we called to have her transported to the hospital.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,SEN,50mg diphenhydramine,miscarriage on 1/5/2021,asthma,"adverse event of mild skin hives, influenza immunization, unknown date/type/brand/pt age","latex, Percocet, dairy products","['Dyspnoea', 'Pallor']",1,PFIZER\BIONTECH,IM 926771,NY,33.0,F,"Patient reports experiencing bright red blood in stool beginning ~ 30 hours after 1st dose of Covid19 Moderna Vaccine. She also reports experiencing fatigue and headaches. Stool guaiac positive on exam. Referral to GI and lab tests conducted today, lab tests pending. Pt has a history of iron deficiency anemia requiring IV Feraheme transfusion.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Vienva 0.1-20 mg-mcg tablet, 1 tablet daily","Iron deficiency anemia, beta thalassemia trait","Iron deficiency anemia, beta thalassemia trait",,No known allergies,"['Blood iron', 'Fatigue', 'Full blood count', 'Haematochezia', 'Headache', 'Metabolic function test', 'Occult blood positive', 'Vitamin B12']",1,MODERNA,SYR 926772,FL,26.0,F,"Itching, swelling, redness and hardness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/31/2020,7.0,PVT,No,No,No,,No,"['Erythema', 'Induration', 'Pruritus', 'Swelling']",1,MODERNA,IM 926773,AR,44.0,F,They did not provide lot number. I was diagnosed with COVID-19.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/26/2020,2.0,PUB,Omeprazole. Ramacade infusions every 8 weeks. Vit b12 injections monthly.,,"Crohns disease, raynauds syndrome.",,"Penicillin, Latex,","['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 926774,CA,49.0,F,"Patient reports Disoriented, patient feels like she was drugged, dizziness, facial numbness on the lft side, especially on the cheek, coming from neck. Back of head. numbness and tingling feeling on the back of the head and both arms and the hands. Patient reports headache as well. Also feeling fatigued",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,Regular daily,,,,,"['Disorientation', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Headache', 'Hypoaesthesia', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 926775,MA,71.0,M,"Mild bilateral upper extremity redness, without rash nor hives. Denies any respiratory symptoms. Benadryl 25 mg po given/ tolerated well with symptoms subsided within 25 minutes.Discharged to home in stable condition",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,,,,,NKDA,['Erythema'],1,MODERNA,IM 926776,MO,59.0,F,"CHILLS, BODY ACHES",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/07/2021,2.0,PVT,,,,,LISINOPRIL,"['Chills', 'Pain']",1,PFIZER\BIONTECH,IM 926777,KS,51.0,F,"36 hours after receiving the vaccine I was awakened at 4:00 AM 12/20/20 by muscle fasciculations- mostly in my legs. It was very bothersome and caused difficulty sleeping for a few days. The second week after the vaccine it seemed to get better. I?m due for my second dose tomorrow and the fasciculations are back as of a few days ago, around 1/4/21. I?m wondering if I should get the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/20/2020,2.0,PVT,Flonase nasal spray prn Valcyclovir 1000mg prn Aleve prn,None,Seasonal allergies Genital herpes,,None,"['Muscle twitching', 'Sleep disorder']",1,PFIZER\BIONTECH,IM 926778,NY,63.0,M,"Person had a fever of 102.4, pulse rate of 118, he was non-responsive with edema of the right calf & ankle this morning when he was assessed.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/06/2021,01/07/2021,1.0,PUB,,"none known, person did","Developmentally disabled, history of lower extremity edema",,None known,"['Oedema peripheral', 'Pyrexia', 'Unresponsive to stimuli']",1,MODERNA,IM 926779,OH,28.0,F,"After receiving vaccine, woke up around 3 am experiencing nausea, loss of vision x 1-2 minutes, syncope, difficulty breathing, numbness & tingling in hands and feet. Measured temperature of 102 F. Slept most of the next day and missed work x 1 day. The following day was improved but still with moderate fatigue and nausea. Took ibuprofen with some improvement.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,,None,History of syncope,,Allergic to aspirin No history of vaccine related allergies or adverse reactions,"['Blindness', 'Body temperature increased', 'Dyspnoea', 'Fatigue', 'Hypoaesthesia', 'Impaired work ability', 'Nausea', 'Paraesthesia', 'Somnolence', 'Syncope']",2,PFIZER\BIONTECH,IM 926780,IL,86.0,M,"Low grade temp, achy, weakness, decreased appetite.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,SEN,,,,,,"['Asthenia', 'Decreased appetite', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 926782,,27.0,F,"Pt experienced vertigo, spinning and headaches after vaccine administration",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Headache', 'Vertigo']",1,PFIZER\BIONTECH,IM 926783,IL,55.0,M,Sub centimeter sore L lay tongue with resultant adenitis. Gone in < 48 hrs.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,OTH,,,,,,"['Glossodynia', 'Lymphadenitis']",1,PFIZER\BIONTECH,IM 926784,OH,57.0,M,PATIENT ADMINISTERED WRONG DOSE OF 1ML INSTEAD OF 0.5ML. NO S/SX OF ADVERSE REACTION NOTED.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Extra dose administered', 'No adverse event']",1,MODERNA,IM 926785,CA,22.0,F,"at 12:24 pm, 10 minutes after receiving vaccine, pt reports feeling dizzy and throat tightness. pt denies short of breath, or any pain 12:29 pm pt evaluated by EMS BP 122/87, P 70, O2 Sat 100% 12:33 pm pt transported to hospital for evaluation",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,"Wellbutrin, gabapentin",na,na,,na,"['Dizziness', 'Throat tightness']",1,PFIZER\BIONTECH,IM 926786,CA,42.0,M,"fogginess for about 45 minutes shaky on the inside for about 45 minutes pimples around face, on breast and chest area, forehead soreness on injection arm",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/07/2021,2.0,UNK,,,,,,"['Acne', 'Feeling abnormal', 'Injection site pain', 'Nervousness']",1,MODERNA,SYR 926787,MN,53.0,F,"Resident had the COVID vaccine 12/30/2020. 12/31/20, resident has been in bed all shift. Staff became concerned when resident was not easily aroused. Resident displayed signs of tremors, twitching, confusion, in and out of consciousness, low O2 sats, elevated pulse and fever, fatigue and weakness. Writer called NP. NP stated this is most likely a reaction d/t the COVID vaccine. She gave orders for Benadryl 25mg IM x1 now and Tylenol 1000 mg now. NP also stated resident will not be getting the second dose of vaccine. Will continue to monitor and update NP if worsening symptoms. After receiving Benadryl and Tylenol at 145pm, resident began to appear as though she was feeling better and was talking to talk, fever had gone down. Tonight resident is not easily aroused, lethargic, continues to have tremors and twitches, almost appearing as convulsions. When asked if she knows where she is or what day it is, resident can properly answer. Resident denies SOB but staff has noted loud squeals while breathing. NP was updated and gave new orders to give Benadryl 25 mg IM x1 if needed and Ok to send resident to ED. Resident currently refuses to go to the hospital. Will continue to monitor. BP 152/112, P 116, T 99.1, O2 87-91. Resident's O2 at 1205am was 80% on 3LPM. Resident unable to be aroused from sleep by writer. NAR called to assist. NAR could not arouse resident. Writer and NAR attempted to reposition resident and resident's breathing became more labored. Resident turned back to previous position and writer called on call MD at approx. 1220am. MD returned call approx. 1235am with orders to send resident to ED. 911 called and ambulance arrived about 1245am. History of present condition given to EMTs and they stated resident would be going to Hospital. Writer has attempted to contact Hospital ED x3 but have been unable to get through. An EMT did just call to clarify when vaccine was given, what symptoms have been present and when they started. She said she has everything she should need and she will let Hospital ED staff know to call if they need anything else. Writer will again attempt to contact them though. Resident's temp was 97.5 and BG 128. When EMTs arrived they got an O2 reading of 60%. Resident did open her eyes a couple times during transfer from bed to stretcher and while stretcher was going outside but no responses from resident were made.",Not Reported,,Yes,Yes,6.0,Not Reported,Y,12/30/2020,12/31/2020,1.0,SEN,"gabapentin, asa, oxycodone, fentanyl, flexiril, requip, omeprazole, keflex, symbicort, restasis, spiriva, synthroid, tylenol, simvastatin, lasix, aldactone",,"DM2, COPD, chronic uti/ neurogenic bladder, CKD, obesity, depression,",,"bee stings, abilify, flowers,","['Asthenia', 'Blood glucose normal', 'Breath sounds abnormal', 'Confusional state', 'Consciousness fluctuating', 'Depressed level of consciousness', 'Dyspnoea', 'Fatigue', 'Heart rate increased', 'Lethargy', 'Muscle twitching', 'Oxygen saturation decreased', 'Pyrexia', 'Seizure like phenomena', 'Tremor']",UNK,MODERNA,IM 926788,TX,18.0,M,"Red, blotchy rash forming on and below chest and neck appearing about an hour after vaccination. Not itchy. Resolved within an hour.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,Multivitamin Montelukast Cetirizine Guafenisin Fish Oil Glucosamine,No known,No known,,No known,"['Rash', 'Rash erythematous', 'Rash macular']",1,MODERNA,IM 926789,NY,40.0,M,"approximately 5 minutes post vaccine pt reported feeling tachycardia and bilateral hands tingling. HR noted to be 117 -122, BP 125/79 RR 16 NAD, Lungs CTA bilaterally no wheeze, neck: no stridor, no oral changes. Pt HR 92 after 10 minutes, and reported resolve of symptoms. Pt monitoring extended for a total of 1 hour, no recurrence or progression of symptoms. discussed use of Epi, pt has own epi pen on hand. Pt to discuss with allergist tomorrow, will use Epi if needed as discussed, and instructed go to the ED if any progression of symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,"prn Flovent HFA , prn Claritin prn albuterol , prn Flonase ,",none,Asthma Eosinophilic Esophagitis,,Food allergy not specified,"['Paraesthesia', 'Tachycardia']",UNK,MODERNA,IM 926790,FL,44.0,F,"Following administration of the first dose of COVID-19 vaccine (Pfizer), pt reported feeling tired and having a ""metallic taste"" in her mouth. Pt reported very little fluid or food intake prior to the vaccine. Given Gatorade and crackers; monitored for 30 min. Symptoms resolved. Patient received 2nd dose of vaccine on 1/6/2021 and no adverse reactions were reported during the 30 minute monitoring period.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,PVT,None known,None known,None known,,None known,"['Dysgeusia', 'Fatigue']",1,PFIZER\BIONTECH,IM 926791,CA,53.0,F,"Injection site soreness for ~24 hours (nothing more than the usual I've experienced with other types of vaccinations), then developed acute urticaria over 35% of my body on evening of Jan 4th. Distribution is very symmetrical involving upper arms, back of arms, pits, belly, small area of chest, front of thighs and center of back. No known exposure to possible allergens, bite, etc. Pruritis and hives have persisted. Pruritis decreases with histamine and topical medication such as diphenhydramine, fexofenadine and hydrocortisone cream 1%. No decrease in number, minimal change in appearance. Urticaria are an ongoing issue in this week however have never had a reaction to anything like this. Otherwise I am normothermic, normal SpO2 on room air, no dyspnea, normal GI, just itchy! And ugly blotchy... Sigh.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,OTH,"Atenolol, Vits B12, C, D3, E, Calcium, Mg, Zn, Evening primrose oil, Biote implant (est/test), melatonin",None,"Exercise induced asthma(infrequent), intermittent arrhythmia (PVCs, early tachycardic rise, occasional), microscopic colitis (remission), plantar fasciitis, Dupuytren's",,"None known, only hay fever and occasional heat related eczema","['Injection site pain', 'Pruritus', 'Rash macular', 'Urticaria']",1,MODERNA,IM 926792,OK,82.0,M,Pt. received 1st dose of Moderna on 12/28/20 and on 01/06/21. Pt. was evaluated by ARNP and Dr. will follow up,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,,,,,,['Inappropriate schedule of product administration'],2,MODERNA,IM 926793,IL,34.0,F,"1/7/21 Patient reported that she had an immune system response a week after she received the Covid vaccine on 12/22/20 that sent her into a Lupus flare up. Her Lupus had been under control, but this was the worst flare-ups that she has had. She said she could not even move and her husband had to pick her up. She had head to toe joint pain and rated this a 10. She also had had headache and extreme fatigue. She saw a physician and she was tested for Covid, strep and influenza, which were all negative. She was prescribed emergency steroids. She did not miss any work because she was on scheduled PTO time. Saw her Rheumatologist ion 1/6 and her hydroxy-chloroquine dose was doubled. Still having fatigue, headaches and joint pains, which she said are not her usual Lupus symptoms. She saw her Rheumatologist again yesterday and he is recommending that she not receive the second vaccine dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/29/2020,7.0,OTH,"Hydroxy-chloroquine, Baby aspirin",,Lupus,,,"['Arthralgia', 'Condition aggravated', 'Fatigue', 'Headache', 'Influenza virus test negative', 'Mobility decreased', 'SARS-CoV-2 test negative', 'Streptococcus test negative', 'Systemic lupus erythematosus']",1,PFIZER\BIONTECH,IM 926794,NY,44.0,F,"Eight days after receiving vaccine (today) I began to notice itching, redness, swelling at the injection site as well as it was warm to touch. Will seek medical attention if it worsens or doesn't improve.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/07/2021,8.0,WRK,none,none,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 926795,OH,67.0,M,"Patient is employee who got shot at 2pm during our employee vaccine clinic. At 9pm he had difficulty walking, describes limping due to right hip and right knee pain/numbness. Pain improved after sleeping. Has artificial joints in right hip and right knee.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,unknown,unknow n,right knee and right hip replacement,,unknown,"['Arthralgia', 'Gait disturbance', 'Hypoaesthesia']",1,MODERNA,IM 926796,CA,32.0,F,"Vitamin C, Amlodipine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Vitamin C, Amlodipine",no,hypertension,,Contrast dye and latex,['Unevaluable event'],1,PFIZER\BIONTECH,IM 926797,SD,93.0,M,"had a vaccination on 12/31/2020 late morning passed away early morning 01/01/2020. This is a 93 year old with significant heart issues. EF of 20% among other comorbidities. He died suddenly approximately 0430, it is unlikely it was related to receiving the vaccine.",Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,SEN,,"This is a 93 year old with significant heart issues?EF of 20% among other comorbidities. He died suddenly approximately 0430, it is unlikely it was related to receiving the vaccine",Heart disease,,,['Sudden death'],1,MODERNA,IM 926798,NV,17.0,F,"Medication error: first dosage of Moderna Covid Vaccine 0.5 cc given to patient under 18 years of age (17 years old). No complaints or adverse reactions noted. Parent (EMT) contacted & advised to observe for any adverse reaction, if any.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,unknown,unknown,unknown,,unknown,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 926799,OH,55.0,M,PATIENT RECEIVED WRONG DOSE OF VACCINE AT ADMINISTRATION. PATIENT RECEIVED 1ML INSTEAD OF 0.5ML DOSE. NO S/SX OF ADVERSE EFFECTS NOTED AT THIS TIME.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'No adverse event']",1,MODERNA,IM 926800,CA,32.0,F,Lightheadedness Fatigue Dizziness Sore arm Nausea Malaise,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,WRK,None,None,None,,None,"['Dizziness', 'Fatigue', 'Malaise', 'Nausea', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 926801,IL,41.0,F,"I received the injection around 2:15 pm. There were no immediate effects. By late afternoon/early evening, my arm was a bit sore and later started to feel warm near the injection site. However, I otherwise felt fine. At 9 pm, I suddenly became very dizzy and passed out for several minutes. When I regained consciousness, I felt a little short of breath, which resolved within 20 minutes or so. However, I was also extremely nauseous, which got worse any time I tried to move. This continued for several hours. I also alternated between being very warm and chills during this time - it was like waves of heat. I did not have a fever. Later, my head began to hurt and I took tylenol to help with that. I also had diarrhea. These symptoms began to gradually lessen after a couple of hours and I was able to fall asleep around 12:30 pm. I woke up hot and sweaty several times throughout the night. The following day, 1/6, I was very tired and had a headache and could not eat much, but otherwise felt much better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,Loratidine 10 mg for allergies,None,"None; I do have a previous history of vasovagal syncope, but have not passed out in eight years.",,None,"['Chills', 'Decreased appetite', 'Diarrhoea', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Feeling hot', 'Headache', 'Injection site warmth', 'Loss of consciousness', 'Nausea', 'Pain in extremity', 'Sleep disorder']",1,MODERNA,SYR 926802,IA,27.0,F,"Reports symptoms started 1/7/21 7 AM with pounding headache, nausea, rapid heart rate. Had chills that shook her in night. Went to work. HR has been 100 since awakening. Injection site is red and inflamed. B/P 142/100. Instructed to go to urgent care. Urgent care sent her to Emergency Dept. Per Dr., ED provider, he wanted VAERS completed. Patient has tachycardia 140-150. No rash or swelling. Has body aches and Headache. Temp is 100.3. Undecided if will be admit to hospital at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,Unknown,Unknown,Unknown,,unknown,"['Body temperature increased', 'Chills', 'Headache', 'Heart rate increased', 'Injection site erythema', 'Injection site inflammation', 'Nausea', 'Pain', 'Tachycardia']",1,MODERNA,IM 926803,MA,36.0,F,Patient reported having heaviness in her throat and upper eyelids. She was complaining of chest palpitations and fast heartbeat. Patient conveyed to nurse her symptoms 20 mins after sitting when she was about to leave facility. She presents alert and orientated times three. Handoff to EMT team. Vital signs are stable. POC 81. She began scratching her right arm marks noted but she states they are old bites. She reports her eyes feel heavy and her vision is cloudy. Advised to rest on stretcher. She declines to go to the ER. She was observed for 45 mins. Snack provided. She states she will return to work she states she feels much.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,Zoloft 50 mg daily Ambien 10 mg daily taken last evening,,,,NKA,"['Asthenopia', 'Discomfort', 'Heart rate increased', 'Palpitations', 'Vision blurred']",1,MODERNA,IM 926804,CA,21.0,M,Sore arm after injection about 12 hours after that lasted a full day or longer. Severe headaches and migraines approximately 2 days after injection. 5-6 Days after vaccine developed swollen lymph nodes in right arm pit and intermitten pain to move arm that lasted for 2-3 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/03/2021,5.0,OTH,None,None,None,,No allergies aware of,"['Headache', 'Injected limb mobility decreased', 'Injection site pain', 'Lymphadenopathy', 'Migraine']",1,MODERNA,IM 926805,CA,42.0,F,"12 minutes post vax felt warm, dizzy, hypotensive, syncope. Transferred to ED, monitored and discharged. On 12/24/2020 developed cyanosis to lips. Returned to ED and placed on 5 day steroid therapy and diphehydramine. Mildly improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/23/2020,0.0,PVT,,,,,,"['Cyanosis', 'Dizziness', 'Feeling hot', 'Hypotension', 'Syncope']",1,PFIZER\BIONTECH,IM 926806,CO,61.0,F,"Chills, fatigue, nausea starting about 30 hours after vaccine was given. It is now the following day and my symptoms are getting a little better. Chills and nausea are gone, but I?m still very fatigued. I have been resting a lot, and drinking a lot of fluids. I notified my local caregiver and the agency where vaccine was administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Omega-3, D3, probiotics",None,"Reactive airways, overweight",,Lisinopril,"['Chills', 'Fatigue', 'Nausea']",1,MODERNA,IM 926807,NJ,63.0,M,Diffuse body aches upon awakening. Temp at 4:00 PM 101.7F,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PUB,"Multivitamin QD, beet root 1000 mg QD, ASA 81 mg QD, bupropione 300 mg QD, Famotidine 20 mg QoD, Omeprazole 20 mg QoD, Amlodipine-Benazepril 10-29 mg QD.",None,Well controlled HTN and GERD. Dysthymia.,,None,"['Body temperature increased', 'Pain']",1,MODERNA,IM 926808,NM,33.0,F,"The morning after I received the shot in my right arm, I woke up and jumped out of bed to turn off my alarm. My right leg buckled and completely gave out. It felt like there was not a muscle or bone in the leg. I melted down on top of my leg, twisting my ankle and my knee. I ended up with my knee twisted behind me as I hit the floor and my nightstand. I don't know if you would call it muscle fatigue or weakness, it felt like muscle paralysis, but it only lasted less than a minute before it was gone, however, the damage was already done. I hurt my knee very badly because I had no control over my leg muscles. I've never had anything like that happen before.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,Daily Multi-Vitamin,,Migraines and headaches,,None,"['Coordination abnormal', 'Fall', 'Gait disturbance', 'Ligament sprain', 'Paralysis']",1,PFIZER\BIONTECH,SYR 926809,FL,53.0,F,Dizziness from 12/29/20 . Ongoing but has been decreasing as of 1/6/21,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,WRK,"Lotrel, Levothyroxine, Neurontin, Zolpidem, Melatonin, Ibuprofen",,"HTN, Hashimoto's Thyroiditis, Restless Legs, Anemia",,Calamine and Caladryl lotion,['Dizziness'],1,MODERNA,IM 926810,LA,,F,"Patient complained of itching of tongue, mouth, and lips. Given po Benadryl 50mg, 40mg Pepcid po, and Xyzal 5mg po. Complained of hoarseness also. Observed slight puffiness of lower lip. Patient discharged 3 hours later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Prozac Mirena Protonix,none,thyroid nodule,,Codeine,"['Dysphonia', 'Lip pruritus', 'Lip swelling', 'Oral pruritus', 'Rhinoscopy', 'Tongue pruritus']",1,PFIZER\BIONTECH,IM 926811,AL,51.0,F,"After receiving vaccine, reported a headache and was monitored for 30minutes. Recipient experienced arm swelling, and pain and redness at injection site, which was relieved by Benadryl. This swelling, redness and pain occurred about 3 additional times over the week and was relieved by Benadryl. On 01/07 (7d post vaccine) she reports significant arm swelling (twice the size of other arm), redness and hard lumps at the injection site. As instructed she followed up with her PCP who diagnosed as vaccine allergic reaction and instructed that she not receive the second dose of the vaccine. She was treated with IV and oral steroids.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,,,,,No known allergies,"['Headache', 'Hypersensitivity', 'Injection site erythema', 'Injection site induration', 'Injection site mass', 'Injection site pain', 'Injection site swelling', 'Peripheral swelling']",1,MODERNA,IM 926812,PR,59.0,F,"Swelling, redness on injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/04/2021,9.0,UNK,None,High cholesterol,High cholesterol,,None,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,UN 926813,MA,32.0,F,"Patient c/o itchy, numb feeling in upper left arm. Fingers mobile, pink. No numbness down arm. No CP, SOB, palpitations, itchy throat. Denies any other complaints. Seen by EMS. Right upper arm red, flushed. Redness not extending down arm. VSS-BP-162/100,HR 115-120. T-97.5. States mother in law had MI today and she has been stressed and drinking caffeine. She will take Benadryl when she gets home and call MD for any questions or concerns, follow instructions per handout. She is aware to seek emergent care if needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,Adderall,None known,ADD,,"Shellfish, Amoxicillin, Sulfa","['Erythema', 'Flushing', 'Hypoaesthesia', 'Pruritus', 'Skin discolouration', 'Stress']",1,MODERNA,IM 926815,,32.0,F,large red raised circle at injection site. Chills and fatigue.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,PVT,,,,,,"['Chills', 'Fatigue', 'Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 926817,TX,72.0,M,"headache, muscle aches, low grade fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,Sulfamethoxazole-Trimethoprim,None,None,,Weed and tree spores,"['Headache', 'Myalgia', 'Pyrexia']",1,MODERNA, 926818,,32.0,F,"Localized rxn at injection site. Red, raised circle.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site swelling', 'Local reaction']",1,MODERNA,IM 926819,PA,60.0,M,Could not get out of bed had really bad back pains.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,1 a day multi vitamin Plant sterols (for colesterol),None,None,,No,"['Back pain', 'Mobility decreased']",1,MODERNA,SYR 926820,CO,45.0,F,"Exactly 7 days later, the area below the site of injection was slightly swollen, red, and itchy. I was prescribed a cortisone ointment and allergy medicine from my doctor. The doctor had the same reaction about 6-7 days after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,Zinc/Vit D/Protonix,A cold,asthma,,Shellfish and hayfever,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 926821,CA,49.0,F,"felt drugged, bumping into things, everything going in slow motion both arms were numb an tingly, also hands flushed feeling over neck facial numbness on the left check headache dizziness neck pain throat pain numbness and tingling on right arm fatigue feels unwell",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,UNK,,,,,,"['Bradykinesia', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Flushing', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia', 'Malaise', 'Neck pain', 'Oropharyngeal pain', 'Paraesthesia']",1,PFIZER\BIONTECH,SYR 926822,MD,38.0,F,Lymph node under left arm painful on Day 7 after the vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PUB,none,Stuffy nose the day of that had just started.,none,,none,['Lymph node pain'],1,MODERNA,SYR 926823,ND,86.0,M,Patient wasn't feeling well on Jan 2nd. felt like someone is pushing on his chest and is Short of breath. b/p 119-69 P 62 R 26 no temp. patient evaluated in ED symptoms subsided quickly and returned to normal environment. Same similar symptoms occurred again on Jan 6th. symptoms again subsided quickly. NO previous history of any cardiac disease.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/02/2021,4.0,PVT,,,,,,"['Cardiac telemetry', 'Chest discomfort', 'Dyspnoea', 'Electrocardiogram', 'Malaise', 'Troponin increased']",1,MODERNA,IM 926824,WA,38.0,M,"Headache and pain in neck. Intermittent, usually lasting about 3 hours. Had experienced for several days after vaccine administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,WRK,,,,,,"['Headache', 'Neck pain']",1,MODERNA,IM 926825,UT,32.0,M,"12 minutes after vaccine had left sided chest pain and mild shortness of breath. In the evening the same day developed chills and diffuse muscle pain. Following was lightheaded, waves of Tachycardia (resting HR 50s would go as high as 120s at rest). Symptoms came in waves of chest pain, SOB, lightheaded and tachycardia throughout. Patient seen in clinic 1/7/2021 with symptoms slightly improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,"Dolutegravir, Truvada, Zofran, Fish Oil, Vitamin D, Vitamin C",None,HIV-well controlled,Bells Palsy with Influenza,"Fluoxetine, Raltegravir, Stribild, Sulfa, Epinephrine","['Chest X-ray normal', 'Chest pain', 'Chills', 'Differential white blood cell count normal', 'Dizziness', 'Dyspnoea', 'Electrocardiogram normal', 'Full blood count normal', 'Metabolic function test', 'Myalgia', 'SARS-CoV-2 antibody test', 'Tachycardia', 'Troponin']",1,PFIZER\BIONTECH,IM 926826,MA,41.0,F,"On 12/25, I woke up feeling fatigued with slight body aches. I had significant soreness in my left arm where I received the vaccine, radiating down to my forearm. At approximately 7-8pm, I felt extremely cold. I then noticed I had a flat, red rash on my face, chest, upper back, and shoulders. There was no difficulty breathing, swallowing, or associated itching. My temperature was 99.0. I went to bed at approximately 10pm, with no change in the rash. I woke up the next morning at about 6am. The rash was gone, and I felt well. On 12/31, I developed moderate itching in the area of my left upper arm. I noticed swelling, redness, and warmth in what felt like the exact area where I received my injection. This continued into 1/1 except the itching had resolved, and I felt point tenderness as well as a cool, tingling sensation in my left upper arm. On 1/2 there was a shadow of redness in the area of my left upper arm, but the warmth, swelling, and tingling sensation had resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/25/2020,2.0,WRK,Vitamin B Complex Vitamin C 1000mg Calcium plus D 500mg/800units Magnesium 500mg Ashwaganda 4200mg Progesterone topical cream Flonase Probioitic,None,None,,None,"['Fatigue', 'Feeling cold', 'Injection site coldness', 'Injection site erythema', 'Injection site pain', 'Injection site paraesthesia', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Pain in extremity', 'Rash', 'Rash erythematous']",1,MODERNA,IM 926827,CA,37.0,F,"Per RN ->Patient received her Pfizer vaccine at 0835. At 0845, she came to me and reported that her shoulder was achy and the pain rated 4/10 was radiating to her back. I checked the injection site and arm and it was not red, raised, or warm. Pt did not have any other symptoms, just the achy shoulder. Pt also reported a brief burning sensation in her shoulder that subsided within 1 minute. She later felt that same sensation in her forearm and it also subsided. It was recommended that she go to the ED for monitoring since the pain was radiating further from her shoulder. ED RN took her in at 0905 and I left.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Back pain', 'Burning sensation', 'Injection site pain', 'Pain']",1,PFIZER\BIONTECH,IM 926828,,27.0,F,"localized rxn to left arm injection site. Hot to touch, red, itchy, painful. ABX ordered.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/06/2021,8.0,PVT,,,,,,"['Erythema', 'Local reaction', 'Pain', 'Pruritus', 'Skin warm']",1,MODERNA,IM 926829,HI,62.0,F,"REDNESS, WARMTH, PAIN AND SWELLING TO AREA JUST BELOW INJECTION SITE. ONSET YESTERDAY,1/6/2021( 7 DAYS POST INJECTION). SYMPTOMS ARE WORSENING WITH TIME, AND THE AREA IS INCREASING(DOUBLED SINCE YESTERDAY) IN SIZE. CURRENTLY DIAMETER MEAURES 3 1/2 IN ACROSS AND JUST OVER 3 1/4 INCH VERTICALLY. I DON'T HAVE ANY OTHER SIDE EFFECTS.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PUB,NONE,NONE,NONE,,NONE,"['Injection site erythema', 'Injection site pain', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 926830,NY,28.0,F,"Received vaccine at 7:30 am. Afterwards felt diaphoretic, lightheaded, nauseous, and became flush. Rapid Response Team activated and team assessed patient. Patient stated symptoms resolved as RRT team arrived. Patient waited an additional 20 minutes and had a complete resolution of symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Junel Fe,,,,Seasonal rhinitis,"['Dizziness', 'Flushing', 'Hyperhidrosis', 'Nausea']",1,MODERNA,IM 926831,MD,32.0,F,"I started having swelling from the shoulder down, I had site soreness nausea vomiting headache chills fever body aches general malaise lack of appetite, worse than the flu symptoms. I still have some mile symptoms and chills on occasion. The worst of the symptoms is over. I took theraflu and hydrated I only went to the Dr for a note for work",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,MIL,"prozac, vitamin supplement, tylenol",reaction from the first covid vaccine,no,,morphine,"['Chills', 'Decreased appetite', 'Headache', 'Injection site swelling', 'Malaise', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,SYR 926833,NH,58.0,F,"Approx 2 min after getting vaccine I felt lightheaded. I noticed my heart was pounding and racing. I got help and Sat in office with nurse. My pulse was 140's ,I felt sweaty and shaky. Whole episode lasted approx 10 minutes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,"Multivitamin, garlic, Vit D, turmeric, zyrtec, flonase estradiol patch",None,None,,"Codeine, levaquin, walnuts, kiwifruit, latex","['Dizziness', 'Heart rate increased', 'Hyperhidrosis', 'Palpitations']",2,PFIZER\BIONTECH,IM 926834,NC,55.0,M,"fever, headaches, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,none,none,none,,none,"['Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 926835,CT,46.0,F,"At approximately 3:45pm on Tuesday, January 5, I developed a sore throat, chills, sore neck, and headache. These symptoms resolved by the following morning. Again on Wednesday, January 6, at approximately 3:30pm I developed the same symptoms. Again they resolved by the morning. Today, January 7, at approximately 4:15pm I developed the same symptoms. Each time my temperature has been no higher than 98.8. I went for a rapid and PCR COVID test on the evening of Tuesday, January 5. Both tests came back negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,OTH,"Sertraline, 50 mg",None,None,,None,"['Headache', 'Neck pain', 'Oropharyngeal pain', 'SARS-CoV-2 test negative']",1,MODERNA,IM 926837,CO,22.0,F,"Patient received the Moderna COVID19 vaccine in the left arm and waited 15 minutes after administration. She felt fine and decided to drive home. After about a half hour, she noticed that she had some right-sided facial numbness, with the most sensation in the right side of her mouth and her eyelid. After an additional 15 minutes, she states that it is not improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PHM,Probiotic supplement with unknown name,None,None,"vasovagal reaction to a TdaP 10 years prior, at around age 12","Kiwis, bananas, latex",['Hypoaesthesia'],1,MODERNA,IM 926838,CA,43.0,F,"First day tingling menthol feeling in mouth and jaw. Arm was sore. Mild headache, Shoulder pain, Mild pain arm. 12/17-12/18 arm pain got worse every day. 12/19 couldn't sleep at night. 12/20 limited motion in arm. Called doctor12/21. Took 400mg ibuprofen. Took Medrol for shoulder pain. 12/22 not able to sleep. Dr. wrote rx for Flexerol. Continued to take meds. Went back to work 12/23 with some pain. By 12/26 much better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,MIL,"Metformin, Levothyroxine, Fish Oil Multivitamin, Zyrtec, probiotic capsule",no,"diabetes, hypothyroid",,no,"['Arthralgia', 'Headache', 'Insomnia', 'Mobility decreased', 'Pain in extremity', 'Paraesthesia oral']",1,PFIZER\BIONTECH,SYR 926839,FL,34.0,F,"Increased BP, nausea, lymph node under right arm swollen, fever,aches, chills, dizziness. Also unbearable pain in that arm. Ended up with a trip to the ER with diagnoses of cellulitis to the right arm, (same as vaccinated arm). Currently taking antibiotics.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,SEN,None,None,None,,None,"['Blood pressure increased', 'Cellulitis', 'Chills', 'Dizziness', 'Lymphadenopathy', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 926840,AZ,54.0,M,"Date of vaccine 12/7/2020-Patient had very sore painful left deltoid and had to take Tylenol pain level 7 out of 10 and interrupted sleeping. 2nd day-12/18/2020-Patient had left sided body weakness, pain at injection site, pain all on left side of body taking Motrin. On 3rd day symptoms all subsided and were gone. No fevers or chills during any symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,,,,,,"['Asthenia', 'Injection site pain', 'Pain', 'Sleep disorder']",1,PFIZER\BIONTECH,IM 926841,,27.0,F,"Localized rxn to injection site. Warm to touch, red area, itchy. Also reports throat swelling when received the vaccine but resolved with benedryl. No difficulty breathing.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/05/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth', 'Local reaction', 'Pharyngeal swelling']",1,MODERNA,IM 926842,MN,36.0,M,First dose was given 12/21/20 and second dose was given 1/6/2020 at day 16.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,Unknown,Unknown,Unknown,,Unknown,['Inappropriate schedule of product administration'],2,PFIZER\BIONTECH,IM 926843,WI,20.0,F,"body aches day after, vomiting beginning day of and continuing until 12/31, went to ER for fluids and zofran",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,SEN,Lamotrigine 100 mg viibryd 30 mg trazodone 100 mg,,,,penicillin amoxicillin cefuroxime clindamyacin,"['Differential white blood cell count normal', 'Full blood count normal', 'Lipase normal', 'Metabolic function test normal', 'Pain', 'Pregnancy test negative', 'Vomiting']",1,MODERNA,SYR 926844,CA,38.0,F,Bell?s Palsy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,01/04/2021,18.0,PVT,None,None,None,,None,"['Blood test', 'Computerised tomogram head', 'Facial paralysis']",1,PFIZER\BIONTECH,IM 926846,IL,54.0,F,"shoulder pain... which didn?t seem connected to the vaccine... which progressed to pins and needles in the L shoulder, numbness into both hands...of the left arm. And neck pain... cervical radiculopathy in the L arm... pain and pins/needles into L thumb. It reached its peak with 4 nights of disturbed sleep starting on the date mentioned. I didn?t keep track of the symptoms other than that because I didn?t initially associate the symptoms to the vaccine until early this week. Symptoms have since improved and are (almost) resolved; I was advised to have the the 2nd vaccine today as scheduled - which was recommended lower on the deltoid and on the opposite shoulder.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/31/2020,14.0,OTH,"Tylenol and Ibuprofen immediately prior/after vaccination: total: 3 doses of one, other or both.",None. History of L shoulder dislocation and L sided neck pain never requiring treatment or medications/OTC or otherwise prior to vaccination.,"See above. I will not allow me to copy and paste it here. History of R leg sciatica, also without need for medical interventions.",,None.,"['Arthralgia', 'Cervical radiculopathy', 'Hypoaesthesia', 'Neck pain', 'Sleep disorder']",1,PFIZER\BIONTECH,IM 926847,MN,31.0,F,"Body aches, chills, headache, skin burning. Took Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Headache', 'Pain', 'Skin burning sensation']",2,PFIZER\BIONTECH,SYR 926848,AZ,30.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,,,,,,['Unevaluable event'],UNK,PFIZER\BIONTECH,IM 926849,RI,60.0,F,initially sore and red but now 10 days later continue to have an area of red raised warm skin on right arm and it it also frequently itchy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PUB,"Metoprolol, Lisinopril, Omeprezole",None,"HTN, GERD, mild asthma",,"PCN, Sulfa, psyllium and bananas","['Erythema', 'Local reaction', 'Pain in extremity', 'Peripheral swelling', 'Pruritus']",1,MODERNA,IM 926850,WA,38.0,F,"Post Second dose, my right arm is numb from elbow down to the proximal side of my hand. My pinky finger and ring finger are numb. Restless arm. Pain is all the way up to my neck.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Levoxyl, biotin",None,Hypothyroidism,,Nkda,"['Hypoaesthesia', 'Neck pain', 'Pain in extremity', 'Restless arm syndrome']",1,PFIZER\BIONTECH,IM 926851,TX,31.0,F,"On Monday January 4, I had a headache around 3pm around 5 pm I became nauseated and vomiting. Throughout the night I started coughing and had fever. I took Tylenol and made an appointment the following morning with doctor. They tested me for covid. My rapid came back negative as did my send out. I?m still having diarrhea and a really bad cough.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,01/04/2021,34.0,PVT,None,None,None,,Cipro,"['Cough', 'Diarrhoea', 'Headache', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting']",UNK,MODERNA, 926853,TX,47.0,M,"Employee received 1st dose of Moderna vaccine on 12/23, remained for 15 min in observation post vaccination, no complications or reaction at the time, went home. 9 days later 1/1/2021 employee begat to have small rash to R hand/arm, they began to swell into hives. right Hand became swollen unable to close into a fist. Multiple test/labwork run no findings at this time. MD's unable to identify etiology, no new soap, hygiene products etc have been used. He was placed on steroid tx and was out of work for a wk, returned to work 1/7/2020. Symptoms have resolved at this time, MD is advising to get 2nd dose but will be under supervision.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/01/2021,9.0,PVT,Tylenol,None,None at this time,,None,"['Blood test normal', 'Full blood count normal', 'Peripheral swelling', 'Rash', 'Renal function test normal', 'Urine analysis normal', 'Urticaria']",1,MODERNA,IM 926854,MA,59.0,F,"Patient noted mid left side of tongue slight numbness . denies difficulty swallowing, nor resp. distress. Patient given benadryl 25 mg po at 0950. Patient handed to parametics with continued monitoring. Remains alert and oriented x3, VSS 138/80 HR 90 and O2 at 99%, no evidence of rash/hives at present. At 1020 BP 142/78 HR 72 with no worsening of S&S, speech clear, tolerating po fluids without difficulty, no change of tongue .AT 1040, dose of benadryl 25 elixir given per patient request due to concerns that no change of tongue numbness. Accessed tongue to be within nml findings. At 1050, patient cleared for discharge to home with her friend. Gait stable and patient as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,,,,adverse reaction noted to H1N1 vaccine in the past and developed hives,Adverse reaction to H1N1 vaccine/ developed hives. Now on a flu protocol per Dr. Patient today was pre-treated with allegra 60 mg po and tylenol 650mg at home 0845 per M.D. recommendations.,['Hypoaesthesia oral'],1,MODERNA,IM 926855,MA,20.0,F,"I woke up with sever stomach pain and nausea. I could not lay down or else it would hurt worse. By the afternoon this turned into chest pain, shortness of breath, headache, sweating, back and muscle pain, and a fever of 101.4.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/05/2021,3.0,SEN,None,None,None,,Over the counter Nausene,"['Abdominal pain upper', 'Back pain', 'Chest pain', 'Dyspnoea', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 926856,TX,34.0,F,"Estimated due date: 04/10/2021 I started to get very flush and warm, dizzy so I had to sit down for a moment (I had to stop the procedure I was doing in order to sit down and drink some water). I kept trying to hydrate and had a headache the rest of the day and it went through the evening and night. I did not take anything and went to bed with the headache and woke up and felt fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,centroid,no,no,,no,"['Dizziness', 'Exposure during pregnancy', 'Feeling hot', 'Flushing', 'Headache']",1,PFIZER\BIONTECH,SYR 926857,,42.0,F,"Fever, chills, headache, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,WRK,,,,,,"['Chills', 'Headache', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 926858,CA,46.0,F,"Pt reported swelling, warmth itching at injection site, currently 6cm X 6cm pt reports it was much larger. No other symptoms reported. Use ice as needed to provide comfort and continue to monitor.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,None,None,None,,None,"['Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 926859,TX,39.0,F,"Redness, swelling, warmth, and itching at injection site since day 2. Had soreness but that has dissipated. Itching has increased and I am utilizing over the counter hydrocortisone for relief. Contacted PCP today - advised to report and try antihistamine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,"Omeprazole, topiramate, naltrexone, bupropion",Only severe acid reflux,"Acid reflux, Bariatric patient, degenerative disc disease, migraines",,"Sensitivity to adhesives, allergic reaction to epidural shot at time of child?s birth (hives)","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Pain']",1,MODERNA,SYR 926860,VA,39.0,F,Cervical lymphadenopathy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/26/2020,25.0,PVT,"Advair, omeprazole, ibuprofen",None,Asthma,,Benadryl,['Lymphadenopathy'],1,PFIZER\BIONTECH,IM 926861,CA,33.0,M,"Patient is describing headache, related to previous COVID diagnosis, dry throat, fever at 100.8 degrees, chills and nasaea, body aches, paint at the injection site, leading to pain in hands, patient describes numbness in the left hand, which is where the injection site was.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Multivitamins, Tylenol",,,,,"['Chills', 'Dry throat', 'Headache', 'Hypoaesthesia', 'Injection site pain', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA, 926862,NJ,24.0,F,"Chills, feeling feverish, hot, tired, exhausted.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,no,no,no,,no,"['Chills', 'Fatigue', 'Feeling hot', 'Pyrexia']",1,MODERNA,SYR 926863,OR,101.0,F,"Resident reported feeling nauseous and wanted to vomit and did not. Had an episode of diarrhea and needed assistance as she was unable to make it to the restroom (this is not her normal) and was noted to have extremity tremors. Legs and arms were noted to be shaking and resident had c/o not being able to walk steady because of it. Resident was assisted with a shower and after relaxed with no further complaints. Was treated with PRNs for nausea with 20ml of Geri-Lanta Suspension and diarrhea with 15ml of Loperamide HCl Suspension . Pulse was noted at 101 and all other vitals WNL. Resident reported she had not consumed much fluids during the day. Was instructed on hydration and fluids were provided. Resident per post COVID-19 Vaccination protocol was administered PCR COVID test with NEGATIVE results and placed ""under evaluation"" status and placed in ""Special Droplet/Contact Precautions."" Resident reports today ""feeling good"" and has no further noted or reported episodes of diarrhea, nausea or extremity tremors or changes in her gait.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,SEN,None,Has had no acute illnesses recent or within the last several months prior to receiving the vaccine.,"UNILATERAL PRIMARY OSTEOARTHRITIS, LEFT KNEE VITAMIN D DEFICIENCY, UNSPECIFIED MAJOR DEPRESSIVE DISORDER, RECURRENT, MILD HYPOTHYROIDISM, UNSPECIFIED GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS MALIGNANT NEOPLASM OF RECTUM ANEMIA, UNSPECIFIED (PRIMARY) HYPERTENSION",,"Only known allergies: Codeine, Tylenol #3","['Diarrhoea', 'Gait disturbance', 'Nausea', 'SARS-CoV-2 test negative', 'Tremor']",1,PFIZER\BIONTECH,IM 926865,KY,48.0,M,"Patient developed lower L leg and ankle pain 12 hours after vaccine was given. Described as tingling pain. Very sore to touch. No fever, leg swelling, color change.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"amlodipine, aspirin, Descovy, Repatha, Jardiance, Xyzal, losartan, Toprol XL, Ozempic",None,"Allergic rhinitis, anxiety, asthma, type 2 DM, coronary artery disease, empty sella syndrome, nonalcoholic fatty liver disease, h/o syphilis, hypertension, hyperlipidemia, irritable bowel syndrome, migraine, sleep apnea, panhypopituitarism, vitamin D deficiency",,"Atorvastatin, pine nuts","['Arthralgia', 'Blood uric acid', 'Pain in extremity', 'Paraesthesia', 'Tenderness']",1,MODERNA,IM 926866,CA,,F,"Patient received the covid vaccine on 01/06/2021. C/o bodyache, temperature of 99.6, fatigue, and sore arm (no swelling or redness). Denies any ocular, respiratory, or GI symptoms She is breast feeding her infant without any issue.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Fatigue', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 926867,PA,24.0,F,"1/5 2200: Injection site soreness, fatigue 1/6 0600: Fever 99.9, chills, body aches, fatigue, nausea Treated with tylenol and zofran 1/7 1400: resolution of symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Lexapro Vitamin B Vitamin C Prevafim,,Anxiety,,Walnuts Chia Seeds,"['Chills', 'Fatigue', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 926868,PA,49.0,F,"Today was my second dose of the COVID vaccine and just a few short minutes after the injection the injection site start itching. At just about the 15 min wait time after ionjection a nurse asked if i was feeling ok. I told her i was feeling gine but my arm was very itchy. She checked the site and I had redness all around the site and welt size hives around the site. She asked me to stay 15 min longer and I agreed. Shortly after that the hive started to spread to my neck and chest area and I became lightheaded and faint feeling. I became very hot. They gave me and injection of benadryl and since my BP was high and my syptoms were not going away completly I was taken to the ER for monitoring and IV fluids. There I was given more Benadryl, steroids, Pepcid and IV fluids and monitored. I felt much better and was released to go home with a RX for 4 days of steroids.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"BCP, vitamins",none,none,,PCN,"['Blood pressure increased', 'Dizziness', 'Feeling hot', 'Injection site erythema', 'Injection site pruritus', 'Rash', 'Urticaria']",2,PFIZER\BIONTECH,IM 926869,NM,35.0,F,Started having migraine with aura with both 1st and 2nd vaccine dose.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,none,none,none,,none,['Migraine with aura'],2,PFIZER\BIONTECH,IM 926870,CA,44.0,F,Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hurt swollen lymph nodes tingling on the left side of her face,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Axillary pain', 'Burning sensation', 'Dysgeusia', 'Fatigue', 'Lymphadenopathy', 'Neuralgia', 'Pain', 'Paraesthesia']",1,PFIZER\BIONTECH,SYR 926871,TX,58.0,F,"Patient arrived to clinic today reporting adverse reaction to Moderna COVID vaccine received on 12/30/20. She states she experienced pain immediately after injection, and small amount of localized redness and swelling. She reports hx similar reaction to a previous vaccine approximately 5-6 years ago although this is not well documented. She arrived to clinic today to report this reaction and states she continues to have localized redness and swelling. Today is Day 8 after vaccine. Upon inspection, patient has area of redness and edema approximately 3 x 4 inches in size, slightly below right deltoid. She reports self treating at home with Tylenol and Benedryl topical cream and experienced temporary relief. Denies SOB, hives, nausea/vomiting, itching, rash, fever, headaches, or any other symptoms. Advised patient speak with PCP today regarding treatment for localized reaction as well as advice regarding receiving the second dose of vaccine. Patient agreed with plan and verbalized her understanding. She will contact her PCP and if not available will utilize virtual urgent care via the app.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,unknown,denies,unknown,"Patient states she had a similar reaction to a previous vaccine, possibly varicella, 5 years ago but this is not well documented",none known,"['Erythema', 'Immediate post-injection reaction', 'Injection site erythema', 'Injection site oedema', 'Pain', 'Swelling']",1,MODERNA,IM 926872,OH,37.0,F,PATIENT RECEIVED WRONG DOSE OF VACCINE AT ADMINISTRATION - RECEIVED 1ML INSTEAD OF 0.5ML. NO S/SX OF ADVERSE REACTIONS NOTED AT THIS TIME.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Extra dose administered', 'No adverse event']",1,MODERNA,IM 926873,WI,85.0,M,"Fever, Confusion, Weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,SEN,"Metoprolol, Losartan, Pravastatin, Terazosin, Finasteride, Furosemide, Q10, D3, Tramadol, Spiriva, Potassium, Wafarin",Patient was diagnosed with COVID on 11/25/2020,"Anemia COPD, Edema, Atrial Fibrillation, GERD, Hypokalemia, Hyperlipidemia, Hypertension, Type 2 Diabetes, Neuropathy, BPH",,Prednisone,"['Asthenia', 'Confusional state', 'Pyrexia']",1,MODERNA,IM 926874,SC,28.0,F,"During initial screening, patient did not report history of food allergies and the Screening form specifically asks for any past allergic reactions to vaccines or other injectable medications. Patient received vaccination without any problems. Patient came from Immunizations Clinic to post vaccination observation area with her chalk in no distress after 1min of receiving her 1st dose of Pfizer COVID Vaccine. She stated she felt like she was having difficulty swallowing. The patient denied allergy to Benadryl and 25 Mg was offered her immediately, which she took. Physician was at side by this time and EMS was notified. Co-workers with patent said her face appeared ""puffy"" Four minutes after initial symptoms her vitals were as follows: BP 118/79 Sao2 99% on room air HR 97 Physician ordered Epipen and EMS was arrived and placed patient on gurney. Epipen 0.3.mg IM delivered by paramedic. Six minutes after initial symptoms report wasgiven to EMS and patient was taken to the hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,MIL,Brexpiprazole 1mg; 1 tablet by mouth daily Escitalopram 20mg; 1 tablet by mouth daily Loratadine 10mg; 1 tablet by mouth daily,,,,"Not reported in HR, but patient reported severe food allergies to physician at the time of event, patient carries Epi-pen","['Dysphagia', 'Swelling face']",1,PFIZER\BIONTECH,IM 926875,CO,41.0,F,"approx. 4 inch red, raised and itchy rash at and around injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/31/2020,7.0,PVT,"omeprazole, probiotics, albuterol","asthma, GERD",asthma,,"allergies to weeds, grasses, walnuts, kiwis","['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Rash pruritic']",1,MODERNA,IM 926876,LA,31.0,F,"Joint pain, headache, temp of 100.8. Onset day after injection, lasting ~12hr",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,none,none,none,,none,"['Arthralgia', 'Body temperature increased', 'Headache']",1,MODERNA,IM 926877,NM,20.0,F,"15 minutes after inoculation she developed obvious cutaneous flushing, pruritus, and hives with no other symptoms. She was initially given 50mg diphenhydramine PO. Approximately 45 minutes later she reported chest pain and her vital signs were checked and she was tachycardia at 102 BPM. Her BP was 128/74. EMS was activated and she was given 0.3mg of epinephrine IM after which her flushing and pruritus immediately resolved. She described continued mild chest tightness but over stated that she felt much better.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,MIL,Unknown,None,None,,Shrimp?,"['Chest discomfort', 'Chest pain', 'Flushing', 'Pruritus', 'Tachycardia', 'Urticaria']",1,PFIZER\BIONTECH,IM 926878,CA,31.0,F,"Severe Migraine x4 days Nausea, chills, runny nose, loose stool 2x for 1-2 days Cellulitis along injection site started on 1/7/2021 Treatment for to today for observation and Triamcinolone cream 0.5%, and xyzal",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/07/2021,7.0,WRK,None,"severe migraine, chills,nausea, loose stool, runny nose",None,,Benzoyl Peroxide,"['Chills', 'Diarrhoea', 'Injection site cellulitis', 'Migraine', 'Nausea']",1,MODERNA, 926879,MA,46.0,F,sudden itchiness of injection site with raised red hives. eventually growing to one large lump. Talked to immediate supervisor. Went to ED to show Dr. took zyrtek.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,WRK,"levothyroxine 150mcg turmeric, vit d, vit c, krill oil",,,,seasonal allergies,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria', 'Mass']",1,MODERNA,IM 926880,AR,30.0,F,"13 hrs post vaccination started with fever (101), body aches and chills. Today just fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"ACTs,",None,None,,None,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 926881,IL,56.0,F,"Patient was feeling nauseous after the vaccination. Went and ate lunch. When she came back from lunch, she passed out and a code blue was called. She never lost a pulse, but when in the ER she could not speak. She responded to commands without speaking. About 30 minutes later, she finally spoke.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Cholecalciferol 1000 units daily, clobetasol cream, cyanocobalamin 500 mcg daily, fish oil 1,000 mg, meloxicam 15 mg daily, pregabalin 75 mg BID, probiotic daily.",None,"Migraines, scoliosis, vertigo, eczema, cervical neuralgia, and arthritis",,"Adhesive tape, Cymbalta causes severe headaches, Dimetapp decongestant, Latex, lidocaine, antihistamines messes with heart and almost passes out","['Aphonia', 'Computerised tomogram', 'Loss of consciousness', 'Magnetic resonance imaging', 'Nausea']",2,PFIZER\BIONTECH,IM 926882,AZ,37.0,F,"Symptoms started as a cold chill, shaking, and weakness. This started a little after I breastfed my baby. I felt as if my blood sugar levels dropped. I have eaten very light meals earlier. Symptoms lasted for about 40 - 60 min. By 9 pm and after dinner I was back to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Prenatal vitamins Caltrate 600+D,mild asthma,,,Shellfish,"['Asthenia', 'Blood glucose decreased', 'Chills', 'Feeling cold', 'Tremor']",1,MODERNA,SYR 926883,TX,29.0,F,"1/5/20 : 7 AM - and noticed swollen, red, and firm raised area just under injection site. Warm to the touch and slightly itchy like sunburn. 6 PM - Area is doubled in size (about the size /shape of a thumb), much redder, and in a well-defined elongated oval shape. Hot to the touch, firm and painful swelling that made sleeping difficult. Took Aleve and iced it. 1/6/20 7 AM - Red area has spread out into a less defined circle about 2in in diameter. Less swollen and painful but still hot to the touch. 6 PM - Area has spread into tear-drop shape about the size of my palm. Drew a line around the area. Still causes some difficulty sleeping. 1/7/20 - Area is less red and not as painful but I can still feel the original area swollen under the skin and hot to the touch. Spread slowed significantly and mostly stayed in the lines.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PUB,VYVANSE; Melatonin; Clotrimazole,Ear infection,ADHD; Overweight; Contact dermatitis,,Pollen; Contact dermatitis; Oral allergy syndrome,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Sleep disorder', 'Sunburn']",1,MODERNA,IM 926884,MN,23.0,F,"At around 1 pm on 1/5/2021, my right face started feeling weird. There was a tightness/tingling sensation starting below the right eye down to my whole cheek. This reaction was present until the following day, 1/6/21 and seemed to resolve on the morning of 1/7/21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,iron supplements,,,,shellfish,"['Feeling abnormal', 'Paraesthesia', 'Skin tightness']",1,PFIZER\BIONTECH,SYR 926885,OR,101.0,F,"Resident reported feeling nauseous and wanted to vomit and did not. Had an episode of diarrhea and needed assistance as she was unable to make it to the restroom (this is not her normal) and was noted to have extremity tremors. Legs and arms were noted to be shaking and resident had c/o not being able to walk steady because of it. Resident was assisted with a shower and after relaxed with no further complaints. Was treated with PRNs for nausea with 20ml of Geri-Lanta Suspension and diarrhea with 15ml of Loperamide HCl Suspension . Pulse was noted at 101 and all other vitals WNL. Resident reported she had not consumed much fluids during the day. Was instructed on hydration and fluids were provided. Resident per post COVID-19 Vaccination protocol was administered PCR COVID test with NEGATIVE results and placed ""under evaluation"" status and placed in ""Special Droplet/Contact Precautions."" Resident reports today ""feeling good"" and has no further noted or reported episodes of diarrhea, nausea or extremity tremors or changes in her gait.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,SEN,No,No acute illnesses at vaccination and no illnesses up to one month prior to receiving vaccination .,"UNILATERAL PRIMARY OSTEOARTHRITIS, LEFT KNEE VITAMIN D DEFICIENCY, UNSPECIFIED MAJOR DEPRESSIVE DISORDER, RECURRENT, MILD HYPOTHYROIDISM, UNSPECIFIED GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS MALIGNANT NEOPLASM OF RECTUM ANEMIA, UNSPECIFIED (PRIMARY) HYPERTENSION",,"Allergies: Codeine, Tylenol #3","['Diarrhoea', 'Heart rate increased', 'Mobility decreased', 'Nausea', 'SARS-CoV-2 test negative', 'Tremor']",1,PFIZER\BIONTECH,IM 926886,CT,50.0,F,Soreness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/04/2021,3.0,WRK,,,,,Sulfa,['Injection site pain'],UNK,MODERNA, 926887,MS,59.0,F,"1508- Patient complains of itching on arms and face, red palms, red watery eyes, and mild clearing of throat. RN x3 at patient's side. Pulse: 60BPM, Resp: 20, O2 Sat 100% RA. 1510- Benadryl 50mg PO given. Pt anxious and crying at present. Itching and redness of face, arms, and chest continues. Denies Shortness of breath, trouble swallowing, or itchy throat. 1516- Pt sipping on water with fan blowing on patient. Resp.18, O2 Sat 100% RA, Pulse 48-50BPM. Palms remain red and pt. continues to complain of itching on arms and chest. Denies trouble swallowing, itchy throat, or shortness of breath. 1528- BP 158/92, Pulse: 50, Resp. 16. Pt is calm and states is ""feeling much better"". Denies itching of face or arms, shortness or breath. 1535- BP:138/96, Pulse: 52. 1540- Respirations even and unlabored at 16 BPM. No acute distress noted at present. Denies shortness of breath or itching. Pt released from the vaccination clinic and returned to her department walking with another RN. Instructed patient to seek medical attention or go to the emergency department immediately if symptoms return.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,None,"['Anxiety', 'Crying', 'Erythema', 'Lacrimation increased', 'Ocular hyperaemia', 'Pruritus', 'Throat clearing']",1,MODERNA,IM 926888,,17.0,M,"Patient is 17 years old, and signed up for vaccination with Pfizer vaccine, however decided to attend an earlier clinic with his Mother. At the earlier clinic, only the Moderna vaccine was available, and the vaccinator did not realize his age, and administered Moderna vaccine. It was not realized until after vaccination that he was due to receive the other vaccine because of his age. Patient attended the vaccine clinic with his Mother both were aware of the mistake. Patient had no ill effects after receiving the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,,,,,,"['Interchange of vaccine products', 'No adverse event', 'Product administered to patient of inappropriate age']",UNK,MODERNA, 926890,NY,64.0,F,redness/swelling at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,,,,"PCN, Demerol, iodine","['Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 926891,OR,41.0,F,"Pain and swelling at the injection site, approximately 36 hours' duration after onset. Nausea and diarrhea, approximately 18 hours' duration after onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,none,none,obesity,,sulfa antibiotics,"['Diarrhoea', 'Injection site pain', 'Injection site swelling', 'Nausea']",UNK,MODERNA,SYR 926892,WA,55.0,M,"Patient received 0.5mL Moderna Covid19 vaccine at mass vaccine clinic on 12/30. This patient was a walk thru and not a patient of HP at this time. Daughter reported to ARNP,RN Director Clinical Support on 01/03 the following outcomes: Patient first exhibited the first signs of reaction started about 60 hours after vaccine: hives only (no difficulty breathing, dizziness, lightheadedness); applied hydrocortisone cream, took diphenhydramine. Patient slept for a few hours then woke up for lunch. Around 12:30-1:00 the patient exhibited three episodes of syncope. Emergency services was called after the first. Firefighters couldn't find BP, was in 70s by doppler only. Patient taken to hospital for care. Discharged from ED around 5, suspecting hypotension 2/2 to diphenhydramine use. Monitored vitals at home; became severely hypotensive (BP 70s/40s both with automatic monitor and manual read) and lethargic again about an hour or so after, but normotensive again right before about to call ambulance. Pt claimed to be okay and had some dinner. Fourth episode of syncope, ambulance was called. Patient remains at hospital ED since, still in observation unit. BP's normalized but itching returns periodically. IV steroids and diphenhydramine. Took head CT yesterday; no word on the results. Stable and alert enough since yesterday to communicate with us with his phone. Patient is scheduled for an echo to be done today. No hx of severe allergic reaction. Treated for active TB 30 years ago, shingles x2 in the past few years; otherwise healthy 55 y/o male. Pt discharged 01/04 to home with fatigue and malaise. Not additional symptoms reported since then. Provider doing full cardiac and neurologic work up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/02/2021,3.0,OTH,"Patient received 0.5mL Moderna Covid19 vaccine at mass vaccine clinic on 12/30. This patient was a walk thru and not a patient of HP at this time. Daughter reported to ARNP,RN Director Clinical Support on 01/03 the following outcomes:",none,"No hx of severe allergic reaction. Treated for active TB 30 years ago, shingles x2 in the past few years; otherwise healthy 55 y/o male.",,none,"['Blood pressure decreased', 'Computerised tomogram head', 'Electrocardiogram', 'Fatigue', 'Hypotension', 'Laboratory test', 'Lethargy', 'Malaise', 'Pruritus', 'Syncope', 'Urticaria']",1,MODERNA,IM 926893,TX,36.0,F,mucosal erosions and hives,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/29/2020,12.0,OTH,"ocps, nsaids x 1",none,asthma,,none,"['Mucosal erosion', 'Urticaria']",UNK,PFIZER\BIONTECH, 926894,TN,34.0,F,"Dose was administered at 10:16am. Pain at injection site as well as redness and swelling began around 5:00pm on the same day. Pain, redness, and swelling have continued for 24 more hours and has not yet gone away. The swelling is like a hard knot below the skin?s surface, but it protrudes a bit at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,Fluoxetine 10mg,None,None,Shoulder injury due to IM vaccine being given too high.,NKA,"['Injection site erythema', 'Injection site induration', 'Injection site nodule', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 926896,AR,30.0,F,"13hrs post vaccination fever of 101, body aches,fatigue. today just fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,ACT,none,none,,none,"['Fatigue', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 926898,UT,51.0,F,Red itchy warm swollen rash to left upper arm and vertigo which started one week after injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,UNK,"Multivitamin, biotin, l-lysine, vitamin d",None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Vertigo']",1,MODERNA,IM 926899,CA,28.0,F,"Patient received the covid vaccine on 1/26/2021 Two hrs post injection c/o pain/soreness at site. Four hrs post injection c/o general body ache, slight headache, fever 99.7. Denies any respiratory, ocular, or GI symptoms. Note - injection lot # not available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Headache', 'Injection site pain', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 926900,IL,47.0,F,"Initially my arm was sore for about 36 hours. Yesterday on day 7 after my shot, the injection site was increasing in tenderness. By today the injection spot is swollen and I am unable to lift my arm over my head. No fever, or chills. I do have body aches which originally I was thinking was from moving snow and ice.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,WRK,,,,,"cloves, clams and seasonal allergies","['Injected limb mobility decreased', 'Injection site pain', 'Injection site swelling', 'Pain', 'Pain in extremity']",1,MODERNA,SYR 926901,,44.0,F,"Generalized Weakness, arm sore, sore throat, runny nose",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,UNK,,,,,,"['Asthenia', 'Oropharyngeal pain', 'Pain in extremity', 'Rhinorrhoea']",1,PFIZER\BIONTECH,IM 926902,MT,38.0,F,"Headache at the ""back of the skull"" that occurred 2 hours after the vaccine and went away by the afternoon",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,,['Headache'],UNK,PFIZER\BIONTECH,IM 926903,WA,39.0,M,"Very sore arm at site. Mild headache, tired, slight itchy throat. 1 day after getting the shot. Head alittle foggy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Modafinil.,None,Fair,,None unknown,"['Fatigue', 'Feeling abnormal', 'Headache', 'Injection site pain', 'Throat irritation']",1,MODERNA,IM 926904,TX,23.0,F,"Fast Heart rate after an hour and half of injection and shortness of breath . Next morning i woke up sweating and my heart rate was 130 and shortness of breath followed. I then developed a rash the same day which was red and bumpy i also felt really lethargic and fatigued. Day three the rash had a line straight through the middle of it and was itchy the rash was spreading horizontally. After day three I felt better with the only side effect being shortness of breath from time to time. Now on the 7th of Jan I develop the rash again except its raised, the line is back and it itches internally. I don't feel bad , it's just concerning that it came back stronger all the sudden. I don't know if I will be allowed to get the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PHM,,,Fast heart rate naturally,,,"['Condition aggravated', 'Dyspnoea', 'Erythema', 'Fatigue', 'Heart rate increased', 'Hyperhidrosis', 'Lethargy', 'Pruritus', 'Rash', 'Swelling']",1,MODERNA,SYR 926905,CT,50.0,M,"localized raised redness, rash",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/07/2021,8.0,PVT,"Probiotic, creatine",neg,neg,,lactase,"['Erythema', 'Rash', 'Swelling']",1,MODERNA,IM 926906,TX,34.0,F,"I believe I had the Virus already a few days before I received the vaccine. I felt fatigue on Monday after receiving the vaccination. On Tuesday I woke up with sinus issues and felt fatigue all day. Wednesday evening, I lost sense of smell and taste.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Adderall,I believe I was exposed to COVID a few days before my vaccination. I just tested positive on 01/07/21,,,,"['Ageusia', 'Anosmia', 'COVID-19', 'Fatigue', 'SARS-CoV-2 test positive', 'Sinus disorder']",1,MODERNA,SYR 926907,FL,70.0,F,"Size of penny at shot site. Another one beside it, warm, itchy, bubbly or dry skin.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,OTH,"Lorazepam, Lisinopril, baby aspirin, calcium, fish oil.",no,no,,no,"['Injection site dryness', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 926908,IL,33.0,F,"Estimated due date: 02/16/2021 Essentially I just had tiredness, body aches and fever (101.8F), the reason I could not go to work is because I was extremely tired and unable to focus. Symptoms lasted 12-18 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,prenatal vitamin and daily stool softener,no,no,,no,"['Disturbance in attention', 'Fatigue', 'Impaired work ability', 'Pain', 'Pyrexia']",1,MODERNA,SYR 926909,MN,34.0,M,"Immediate pain and loss of range of movement of left shoulder. Physical examination today demonstrates a healing injection site which is fairly superior on the left shoulder, and abduction of the left shoulder which is limited secondary to pain. Patient's physician's impression is that he has a subdeltoid bursitis which was temporally associated to the COVID-19 vaccination. (SIRVA)",Not Reported,,Not Reported,Not Reported,,Yes,N,01/06/2021,01/06/2021,0.0,PVT,None,No acute illness,"Irritable bowel syndrome with diarrhea, eczema, osteopenia, positive human leukocyte antigen b27",,None,"['Bursitis', 'Immediate post-injection reaction', 'Injected limb mobility decreased', 'Injection site pain', 'Shoulder injury related to vaccine administration']",1,PFIZER\BIONTECH,IM 926910,AZ,42.0,F,"Employee was being observed right after vaccine and B/P 146/104, started having left sided head, neck, ear, jaw throbbing pain and a headache, then pain went into left groin area-employee stated, ""It's like I can feel it moving all through my lymphatic system. Then after about another 5 minutes employee became lightheaded and ""fainty"" like feeling and then was nauseated with continued left sided pain as listed above. After about 10 minutes B/P 146/116, employee was transported to the emergency department for further evaluation. 2nd day-12/30/2020-employee had body aches all over, extreme fatigue and headache. 3rd day-12/31/2020-employee was just tired and fatigued. 4th day-1/1/2021-employee had no symptoms and felt much better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Dizziness', 'Ear pain', 'Fatigue', 'Groin pain', 'Headache', 'Nausea', 'Neck pain', 'Pain', 'Pain in jaw']",1,MODERNA,IM 926911,AZ,62.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,,,,,,['Unevaluable event'],UNK,PFIZER\BIONTECH,IM 926912,,73.0,M,"BPPV moderate, nothing else",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/05/2021,4.0,UNK,"Several, basically I developed BPPV of moderate severity, otherwise I am fine.",None,None,,None,['Vertigo positional'],UNK,PFIZER\BIONTECH, 926913,CA,35.0,F,"tachycardia, sweating, dizziness and nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,na,"HYPOTHYROIDISM ADHD, COMBINED PRESENTATION MIGRAINE W AURA THYROID NODULE ACNE � NUTRITION TREATMENT FOR VEGETARIANISM � ATOPIC DERMATITIS � NEUTROPENIA, UNSPECIFIED � GILBERT SYNDROME � CERVICAL LYMPHADENOPATHY � COPPER DEFICIENCY",,na,"['Dizziness', 'Hyperhidrosis', 'Nausea', 'Tachycardia']",2,PFIZER\BIONTECH,IM 926914,NY,40.0,F,"Anxiety, hives, tingling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,Unknown,None known,Hashimotos Disease,,"States various seasonal, medication, and other unidentified allergies","['Anxiety', 'Paraesthesia', 'Urticaria']",1,MODERNA,IM 926915,TX,29.0,F,RED CIRCULAR RASH AND LUMP UNDER SKIN. SKIN IS VERY ITCHY,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PHM,QUETIAPINE / VENLAFAXINE . ORAL CONTRACEPTIVE (CYRED),NONE,NONE,,NO KNOWN,"['Pruritus', 'Rash erythematous', 'Skin mass']",1,MODERNA,IM 926917,LA,52.0,F,Extreme dizziness/ vertigo with difficulty walking,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,SEN,,,,,Possibly penicillin,"['Blood test normal', 'Computerised tomogram normal', 'Dizziness', 'Electrocardiogram normal', 'Gait disturbance', 'Magnetic resonance imaging normal', 'Urine analysis normal', 'Vertigo']",UNK,MODERNA,SYR 926918,MO,17.0,F,No adverse event noted. Patient is 17 years old (17.5) and the approved age for this vaccine is 18. This was inadvertently missed at check-in. Patient suffered no untoward effects,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PHM,unknown,,,,NKA,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 926919,OR,37.0,M,Rash warm to touch at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,SEN,N/a,None known,None known,,None known,"['Injection site rash', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 926921,CO,35.0,F,"Rash left arm, shoulder, stomach - very itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,"Zaleplon, Escitalopram, Estarylla",No,Valley Fever,,"PCN (anaphylaxis) , Neomycin (infection)","['Pruritus', 'Rash']",1,MODERNA,IM 926922,AZ,45.0,M,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/07/2021,3.0,PVT,,,,,,['Unevaluable event'],UNK,PFIZER\BIONTECH,IM 926923,CO,57.0,M,Headache. Fever. 103.5 temperature. Sleepy. Chills. Sore at injection site. Eyes hurt.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/04/2021,3.0,OTH,None,Covid 19 on 12/7/20,Fatigue. I lose focus. Cannot remember things sometimes. Still sore at injection site. Constant slight headache. Very hard time falling asleep. Lethargy.,,None,"['Chills', 'Eye pain', 'Headache', 'Injection site pain', 'Pyrexia', 'Somnolence']",1,MODERNA,SYR 926924,MA,64.0,F,"Woke morning after, 1/4/21 with nausea and headache; by 10:30 a.m. body aches, chills and temp 100.3; Tylenol at that time; To bed at 11:30 a.m. Woke at 5pm with body aches, chills and fever 102.4; Motrin at that time; Morning of 1/5/21 temp 100 most of date with headache, body aches and fatigue; Afebrile by that evening; Morning of 1/6 woke with headache and fatigue; shortness of breath and tachycardia with exertion. Normal HR w/rest. Morning of 1/7 woke with headache that resolved w/Motrin - worked all day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,PVT,"Trazodone, Fluoxetine, Raloxifene, Singulair, Topamax, Levothyroxine, Calcium, Vit D",None,Asthma,,Erythromycin,"['Body temperature increased', 'Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'SARS-CoV-2 test negative', 'Tachycardia']",1,MODERNA,IM 926925,FL,31.0,F,"Today redness, swelling, pain. Redness is very big.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,WRK,birth control,no,no,,no,"['Erythema', 'Pain', 'Swelling']",1,MODERNA,IM 926926,MD,26.0,F,"Vomitting, Fever, Chills, Headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,Valcyclovir Biotin Vitamin C Olly Stress Gummies Cranberry Supplement L-Lysine Women's Multivitamin Women's Probiotic Spironalactone,,,,Seasonal Allergies,"['Chills', 'Headache', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 926927,NC,50.0,F,"Red rash over entire body. Not raised but itchy. Mottled appearance. Started on arm of injection site then spread to both arms, both legs and torso. Approximately 45 minutes after reaction started took diphenhydramine 25 mg x 1 dose. Reaction started to ease off within 1 hour but did not completely resolve until the next morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,"progesterone, estradiol 0.75 mg patch, Vit D3, Calcium Carbonate, Ashwagandha, MVI, fish oil, collagen powder, fiber, red ginseng, Vit C, Best Rest (made by PURE),",NONE,NONE,,NONE,"['Livedo reticularis', 'Pruritus', 'Rash', 'Rash erythematous']",1,MODERNA,IM 926928,SC,31.0,F,"Patient reported to COVID Vaccine administration site two days post vaccination for Pfizer COVID vaccine to report an itchy red, raised bump/hard nodule at the vaccine site. Vitals were as follows: BP 137/74 O2 Sat on RA 99.9% HR 93 Physician evaluated the patient and instructed to apply compress and report to ER if symptoms worsen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/07/2021,2.0,MIL,Citalopram 20mg; Take two tablets by mouth daily,,,,Hydrocodone/acetaminophen - Itchy/Nausea,"['Erythema', 'Injection site nodule', 'Injection site swelling', 'Pruritus']",1,PFIZER\BIONTECH,IM 926929,TX,38.0,F,"ABOUT 5 HOURS AFTER THE IMMUNIZATION, PATIENT STARTED TO HAVE A HEADACHE. THEN PATIENT STARTED EXPERIENCING NAUSEA, LOSS OF APPETITE, FEVER, BODYACHES, AND COUGH AND HAS BEEN HAVING THESE SYMPTOMS EVERY DAY.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PHM,"ADDERALL, WELLBUTRIN XL, CLONAZEPAM, HCTZ, FLUOXETINE, DICYCLOMINE, LISINOPRIL, FIORICET",NONE,HYPERTENSION FROM HEART CONDITION,,"CLINDAMYCIN, BIAXIN, FENTANYL","['Cough', 'Decreased appetite', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 926930,TX,30.0,F,"Physician reported today 01/07/2020 that patient seen today for left arm pain, complained of reaction worsening and affecting her work. On exam she had a large 5x5cm tender mass in posterior upper arm triceps area, consistent with possible sterile abscess. Ordered an ultrasound to be sure and the extent and to determine treatment if any.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/02/2020,12/07/2020,5.0,PVT,None,,None,,None,"['Impaired work ability', 'Limb mass', 'Pain in extremity', 'Tenderness', 'Ultrasound scan']",1,MERCK & CO. INC.,SC 926931,TX,27.0,F,"Redness, warm to touch, and swelling at injection site. Treatment-Benadryl and cold compresses",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/21/2020,1.0,PVT,None,Type 1 Diabetes,Type 1 Diabetes,MMR booster,Zofran,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 926932,NY,41.0,F,"Rash upper chest, light headed, hypertensive, tachycardic",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,Unknown,none disclosed,none reported,,NKA,"['Dizziness', 'Hypertension', 'Rash', 'Tachycardia']",1,MODERNA,IM 926933,OR,50.0,F,"3 hours after injection- headache and dizziness. 8 hours post injection; nausea, diarrhea, temperature, chills, muscle pain, malaise, worsening headache. Flet like flu like symptoms. AE's lasted into the late afternoon with some relief of most symptoms but diarrhea every 30 minutes.. The next day 1/7/2021; fever still present at 100.9, and malaise as well as fatigue and muscle pain- though decreased from the day before. About 30 hours after injection- vomiting started ocurring. Vomiting subsided about 5 hours later with continued nausea. As of 1/7/2021 @16:04 temperature, nausea, muscle pain, fatigue, and malaise still continuing.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"sonota, celebrex, vitamin D, probiotics, flexeril (prn)","FMS, OA, IBS","same as above; IBS, FMS, OA",flu vaccine gives me mild flu symptoms for 12-24 hours post dose,"allergic to wheat, soy, dairy, lavendar, pine trees, cats,","['Chills', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Influenza like illness', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 926934,MT,37.0,M,"Pt awoke and had seizure like activity, went to hospital in neighboring county.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,Unknown,unknown,none,,Amoxicillian,['Seizure like phenomena'],UNK,MODERNA,IM 926935,TX,38.0,F,Pt states the she developed facial swelling a couple of hours after injection. Pt took benadryl and swelling resolved. Pt never complained of tongue or lip swelling or difficulty breathing.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,unknown,none,unknown,,none,['Swelling face'],1,MODERNA,IM 926936,CA,64.0,F,"Patient felt cold, lightheaded and had tingling sensation. Followed by chest pain and shortness of breath. Patient was transferred to stretcher for monitoring. Dose of Solumedrol 125mg was given at 13:42. Dose of Benadryl was given at 13:45. Dose of Epi-pen was given at 14:06 and patient showed some improvement. Then ambulance arrived and patient was taken to hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,,,,,,"['Chest pain', 'Dizziness', 'Dyspnoea', 'Feeling cold', 'Paraesthesia']",1,MODERNA,IM 926937,CA,37.0,F,itchiness below injection site 15 minutes after the injection,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,none,none,none,,none,['Injection site pruritus'],1,PFIZER\BIONTECH,IM 926938,IN,29.0,F,Severe chills with shivering Sweating Severe back and neck pain Headache Nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,UNK,Sprintec,No,Narcolepsy ideopathic hives,,Bactrim - anaphylaxis,"['Back pain', 'Chills', 'Headache', 'Nausea', 'Neck pain']",2,PFIZER\BIONTECH, 926939,WI,56.0,F,"swelling, heat, redness, itching, pain at injection site with onset 7 days after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,"citalopram, esomeprazole, lorazepam, multivitamin",none,"hyperlipidemia, prediabetes, GERD, anxiety",,sulfadiazine,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 926941,CO,83.0,M,"Reaction occurred 9 days after injection: injection site pink and swollen; no fever, pain, other symptoms. No previous complaints Doctor visit on 1/7",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,"Levothyroxine 75 mcg Escitalopram 10mg Vitamins & Minerals Curcumin, MSM, SAMe, PS100, Alpha Lipoic Acid",None,Hypothyroid,,Sulfa drugs,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 926942,VA,33.0,F,Site of injection became very itchy today and noticed large sore knot about the size of a small apple.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PUB,"Birth control pill , women?s multivitamin, zinc",,,,,"['Injection site nodule', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,SYR 926943,FL,55.0,F,"Injection site swollen, raised, itchy, red, hot. Ice pack, benedryl, advil. Slowly went away and then came back again on 01/04/21 woke up 6:00 am injection site raised, itchy, red, hot, swollen. Used hydrocortisone cream and benedryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"Multi Women's Vitamins, Vitamin D, Vitamin B complex",,,,"Sulfa, penicillin, aspartame, phenylketonurics artificial sweetener,","['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling']",1,MODERNA,IM 926944,LA,33.0,F,"Staff member received vaccine .At the 15 minute mark, she reported a headache with pressure behind right eye,slight dizziness. It was described as a rapid onset migraine headache with photosensitivity .She was escorted to empty room with staff and laid down. she was examined per Dr.At the 20 minute mark, she developed a light red rash and began itching. The itching began at the face, radiated to arms and legs and then trunk. No c/o SOB, chest pain or increased heart rate. She reported that it felt like someone poking a finger to her left chest wall for 5 minutes-gently.B/P elevated and monitored by staff for 3.5 hrs and was able to go home with staff/family.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Adipex 37.5mg on saturday and Topmax 50 mcg x 2 days.,Sinusitis last week,PCOS - polycystic ovarian syndrome,,NKDA or food allergy known,"['Blood pressure increased', 'Chest discomfort', 'Dizziness', 'Migraine', 'Ocular discomfort', 'Photosensitivity reaction', 'Pruritus', 'Rash erythematous']",1,MODERNA,IM 926945,IL,24.0,F,"Stated she felt nauseated and threw up. then began to feel itchy and noticed rash on back, stomach, and right foot. Everything else was fine. Denied difficulty breathing.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Nausea', 'Pruritus', 'Rash', 'Vomiting']",2,PFIZER\BIONTECH,IM 926946,WA,36.0,F,"About 24 hours after receiving the vaccine, I had a fever of 100.4 and chills. This lasted for about 6 hours before bed. I woke up in the morning and the fever and chills were gone. I feel like this was a normal immune response but my employer asked me to fill this out.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,WRK,"Gianvi (birth control), Claritin, multivitamin",None,"History of GI issues, IBD.",I often get a slight fever after the flu vaccine,None,"['Chills', 'Pyrexia']",1,PFIZER\BIONTECH,IM 926947,NY,36.0,F,Fever 101.3 with severe body aches and terrible headache since last night until now. It has been more than 24hrs since I received a vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,Tylenol and time to time Motrin 400mg.,No,No,,No,"['Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 926948,NY,38.0,F,post vaccine syncope episode rule out out cva,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,,,MIL,none reported,none reported,none reported,,none reported,"['Computerised tomogram', 'Syncope']",UNK,MODERNA,IM 926949,NH,38.0,F,"Woke up this morning, a week after vaccination. Localized reaction at injection site, itchy, blotchy, swollen and firm slightly larger than the size of a baseball. Also running low grade fever of 100.2. Had been feeling completely normal for the 48 hours prior.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PUB,Aspirin,None,"Provoked DVT in 2007, negative for blood clotting issues. Possible autoimmune issues - recurrent Iritis and occasional minor Alopecia",,None,"['Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Pyrexia', 'Rash macular']",1,MODERNA,SYR 926950,FL,47.0,F,"12/28/2020- received 1st vaccine 12/29/2020- very sore noticed around the 31st redness and swelling appeared 01/05/2021- while in the shower it became extremely itchy, I scratched it. Then forgot about it. 01/06/2021- woke up it was significantly swollen, significantly redder felt like a ball, a little warm to the touch. did not itch it, 01/06/2021 around 4:30 pm s/w Dr. she put me on Benedryl and Keflex. 01/07/2021 swelling and redness have gone done but size has increased. the diameter of the redness is about 3 to 4 inches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,PVT,Adderall and prozac,possible cold or sinus infection,none,,,"['Erythema', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,SYR 926951,ID,30.0,F,"Soreness in right shoulder and wrist night of injection, swelling of right wrist overnight 12/28. Symptoms resolved by mid-day 12/19. Soreness in shoulder and wrist returned evening of 1/6 and persisted through daytime 1/7. Have not yet resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,PVT,None,None,Asthma,,None,"['Arthralgia', 'Injection site pain', 'Joint swelling']",1,MODERNA,IM 926952,LA,34.0,F,"Myalgia all over the body, headache, nausea, vomiting x1, intermittent sheivering and feeling hot",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Feeling hot', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 926953,IL,50.0,F,"Nausea, Chills, Achiness, pain from head to toes",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"MULTIVITAMINS, ESTROGEN",NONE,NONE,,PCN,"['Chills', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 926954,CA,46.0,F,"Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body aches, fast heartbeat. Speech slurred, jaw locking. Taken to ER where she works.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,WRK,no,no,no,,no,"['Asthenia', 'Dizziness', 'Dysarthria', 'Dyspnoea', 'Heart rate increased', 'Pain', 'Paraesthesia', 'Trismus', 'Vertigo', 'Vision blurred']",1,PFIZER\BIONTECH,SYR 926955,CA,31.0,M,"Pt called and stated that he has had a severe headache since vaccine 2 days ago, one episode of nausea and vomiting. Pt spoke to Dr. and provider recommended Tylenol 500 mg TID. Also told pt he he can take ibuprofen, or benadryl sparingly. Report to ER if symptoms worsen. Call and make appt at clinic if symptoms persist for more than 7 days post vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,None,None,NOne,,None,"['Headache', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 926956,SC,25.0,F,"Patient receive the Pfizer COVID Vaccine earlier in the day. She called the Clinic line at 1500 and spoke with a nurse. She said she went to sleep and awoke with numbness in her right hand with pain. She complained of pain radiating from her biceps to her elbow. She states she has a headache along with lower back pain. She states she has nausea, vomiting, and that she feels really bad. She is able to move her right hand but states "" it hurts"". Reported to physician and patient instructed to call Emergency Services.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,MIL,,,,,NKDA,"['Arthralgia', 'Back pain', 'Feeling abnormal', 'Headache', 'Hypoaesthesia', 'Nausea', 'Pain', 'Pain in extremity', 'Vomiting']",1,PFIZER\BIONTECH,IM 926957,WI,25.0,F,"Itching on arms, legs, & back began within 5 minutes of administration. Writer noticed patient itching. No rash appeared. No additional symptoms appeared. Patient kept for additional observation x 2 hours total. MD also assessed patient, recommended Benadryl 25mg to be given which patient took. Patient reported that Itching continued for about 48 hours and then stopped, never worsening. No rash or any other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,['Pruritus'],1,PFIZER\BIONTECH,IM 926958,OR,47.0,F,"Mild throat swell, nausea, blurred vision",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,SEN,Vitamins & ibuprofen,,,,None,"['Blood glucose normal', 'Nausea', 'Pharyngeal swelling', 'Vision blurred']",1,PFIZER\BIONTECH,IM 926959,NC,59.0,F,"Patient felt dizzy quickly progressed to hoarse voice, cough and expressed difficulty breathing",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,,,asthma,,shellfish,"['Cough', 'Dizziness', 'Dysphonia', 'Dyspnoea']",1,PFIZER\BIONTECH,IM 926960,MA,29.0,F,"On 1/3 I developed a rash along my right side, under my right arm pit and along right breast. This progressed the following days, became itchy and painful. The pain was shooting. I saw my PCP office on 1/6 and was diagnosed with Shingles.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,01/03/2021,17.0,UNK,Multivitamin,None,None,,None,"['Herpes zoster', 'Pain', 'Rash', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 926961,OR,58.0,F,"Vaccinated on December 21, 2020. No arm pain, nothing. On December 27th at 4:00 PM sudden onset worst bone pain ever unrelieved with Tylenol, malaise and nausea. December 28th at 1:00 AM awoke in pain and ""on fire"" I have never been so hot, truly felt like my skin was on fire. Tympanic thermometer 99.0F. Awoke feeling fine and went to work thinking this was SE however symptoms recurred later that morning so I went for testing as I could not differentiate between SE vs illness. Covid negative. If this was a delayed response to vaccine, wanted to report: severe bone pain unrelieved w Tylenol , malaise, nausea, 48 hours. thanks, NP",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/27/2020,5.0,WRK,none,none,none,"Severe illness after first influenza vaccine, ill 5 days.",adverse to promethazine - involuntary muscle movement allergies to citrus hives adverse effect -Marcaine- hypotension,"['Bone pain', 'Malaise', 'Nausea', 'Pain', 'SARS-CoV-2 test negative', 'Skin burning sensation']",1,PFIZER\BIONTECH,IM 926963,WI,51.0,F,Fever 103.3 Dizziness Nausea Left arm pain Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,SEN,None,None,None,,"Nickel, morphine","['Dizziness', 'Fatigue', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 926964,AZ,30.0,F,"muscle aches, confusion, fatigue, lymph nodes tenderness in underarms and jaw 1/7/20",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Confusional state', 'Fatigue', 'Lymph node pain', 'Myalgia']",UNK,PFIZER\BIONTECH,IM 926965,HI,63.0,F,"Vaccine area warm to touch, red and itchy. lump is size of width of orange.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PVT,vitamin d,none,asthma,,mahi mahi (fish),"['Injection site erythema', 'Injection site mass', 'Injection site pruritus', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 926966,IN,66.0,F,"Awoke in the middle of the night with spiking fever 101.5, headache, muscle aches, diarhea, In bed from Monday night to Wednesday morning started feeling better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"Cymbalta, Trazadone, Tramadol, Premarin,",none,CREST,,no,"['Diarrhoea', 'Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 926967,TN,55.0,F,"Initially arm sore and swollen on 2nd day. Had body aches, chills, diarrhea, tiredness day 3-5 with continued arm site swollen and sore. On 1/5/20, swelling was decreased to about size of nickel and less sore. On 1/6, arm became more sore, noticed increased swelling and now redness to arm site 1/6 evening. 1/7 Arm remains swollen, red, warm to touch. No drainage. Reported to superviser 1/7 am.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,WRK,"Lisinopril, Atorvastatin, ASA, Fish Oil, Magnesium, Zinc, Vit D, MVI, St John's Wart, Proair MDI PRN","None, I was fine until had immunization","Asthma, HTN, cholesterol, Vit D deficiency","dT - swelling and redness to arm that happened within hours, went away on own within 3 days","Tetanus/Diptheria, Honey, Latex","['Chills', 'Diarrhoea', 'Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 926968,MN,45.0,F,"DIffues hives over chest, abdomen, back, arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Birth Control Pills,"None, but significant side effects from the vaccine (fever, chills, body aches, severe headache)",none,,None,"['Chills', 'Headache', 'Pain', 'Pyrexia', 'Urticaria']",2,PFIZER\BIONTECH,IM 926969,GA,59.0,F,"VERY RAPID HEART BEAT, PULSE, 5:30PM .Lasting now about 45 mins",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,WRK,"Singular, Zyrtec",,none,,none,['Heart rate increased'],1,MODERNA,IM 926970,OR,27.0,F,"Stomach pain to the point of vomit, extreme nausea, lasting for over a week and a half, dizziness, swollen arm, itchy arm up to 10 days latter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,Prozac,,Gilbert's Disease,,,"['Abdominal pain upper', 'Dizziness', 'Nausea', 'Peripheral swelling', 'Pruritus']",1,MODERNA,IM 926971,MA,28.0,F,"Pt reported difficulty breathing, tightness in her throat and felt very dizzy. She was noted to be red faced along with redness in her throat and chest. Pt given Benadryl 25 mg liquid po at 0925 am and coaching for slowed breathing and symptoms recovery. She reported feeling better gradually and with in 15 minutes pt felt much better she declined ER transport",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,Lamictal daily for epilepsysy,,Epilepsy,,NKA,"['Dizziness', 'Dyspnoea', 'Erythema', 'Pharyngeal erythema', 'Throat tightness']",1,PFIZER\BIONTECH,IM 926972,NY,62.0,F,"Under the injection site there was a large raised red spot. Approximently 2""x5"". it was itchy and my arm was swollen. As of today 01/07/2021 it is still visible but not as bad.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,Biotin,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Peripheral swelling']",UNK,MODERNA, 926973,IL,52.0,F,"Temp 101, Oral Chills, body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"Synthroid, Prempro, Lunesta, levofloxacin, ProAir, fluticasone, promethazine",none,Thyroid disorder,,Sulfonamides,"['Body temperature increased', 'Chills', 'Pain']",2,PFIZER\BIONTECH,IM 926974,,54.0,M,"localized swelling, hand/wrist numbness, anxious",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,,,,,penicillins,"['Anxiety', 'Hypoaesthesia', 'Swelling']",1,PFIZER\BIONTECH,IM 926975,,37.0,F,"c/o tickle in throat, lump on throat and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,augmentin,"['Headache', 'Sensation of foreign body', 'Throat irritation']",1,MODERNA,IM 926976,CA,44.0,F,Patient began experiencing fuzzy tongue and itchiness all over within 15 minutes of receiving vaccination. Patient was provided 50mg Benadryl and observed for 15-20 minutes at which point they began improving. Patient was checked in on after about an hour and was doing okay.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PHM,,,asthma,,eggplant,"['Paraesthesia oral', 'Pruritus']",1,PFIZER\BIONTECH,IM 926977,TX,34.0,F,"Currently pregnant. The patient was being observed, and after 10 minutes, she reported being lightheaded, dizzy, and nauseated. Stated did not eat, Vital signs were within normal limit, no c/o of breathing difficulty. The patient was offered some snacks, and cold water. A few minutes later, the patient felt a little better, continued to monitor the patient. The patient was stable, escorted to the car, ate more snacks, felt better, and was released. The patient was educated to register for V-Safe and to call PCP. Followed up later, she got home safely. 12/30/2020: followed on the patient, reported doing much better. Informed nurse that she felt better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PUB,,,,,,"['Dizziness', 'Exposure during pregnancy', 'Nausea']",1,MODERNA,IM 926978,OR,46.0,F,"Patient received 1st dose Moderna Vaccination at 1405, went to sit in observation area and began to feel lightheaded and faint within first few minutes. Escorted to cot to lie down at 1412. 1415 VSS: BP 140/82 HR: 98 steady, RR:18 98% on RA with no visual rash, or difficulty breathing. Pt. reported that she was rushing in to clinic to get the vaccination and was often hot, face flushed at this time though pt reported that this was her baseline. Reported that she continued to feel faint, ABC all within normal limits. VSS continued to be stable with no signs of trouble breathing. Pt remained A&Ox5. 1425: pt reported tingling in hands bilaterally. VSS remained stable, tingling grew stronger in left FA dissipated in the R FA. Pt reported that she continued to feel as if she was unable to sit up, that this would cause her to pass out and that this sensation came in waves. Pt. was monitored for 20 minutes prior to receiving 50mg IM Benadryl in LUA and Code Green was called. Patient taken to ED for further observation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,"Reported that she took Zyrtec, medication for DM, medication for HTN and Celebrex for the first time this AM under the instruction of her PCP to prepare for the COVID Vaccine.","none currently, historical over the past month is unknown","DM, HTN",,nkda,"['Dizziness', 'Dizziness postural', 'Paraesthesia']",1,MODERNA,IM 926979,ID,54.0,F,"Arm from top of shoulder to elbow is very swollen, hot, painful, itchy. Swollen Glands, We have pictures, wont let them load",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/06/2021,6.0,WRK,Trulicity,none,WPW,,"Yes, unknown allergy, but needs EpiPen","['Feeling hot', 'Lymphadenopathy', 'Pain in extremity', 'Peripheral swelling', 'Pruritus']",UNK,MODERNA,IM 926980,IL,29.0,F,"moderate pain at injection site, feels like she cannot lift arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,none,none,none,,none,"['Injected limb mobility decreased', 'Injection site pain']",UNK,MODERNA, 926981,WA,59.0,F,"Pt received .5ml Moderna vaccine in left deltoid at approximate 0915. At 0920 noticed tingling in lips, notified RN at 0930, also reported thickness of tongue. Pt denies difficulty swallowing, denies changes in heart rate/heart palpitations, denied difficulty breathing and dizziness. Pt calm but concerned of symptoms.0940 - Notified health care provider, completed patient assessment, ordered Benadryl 25mg p.o. to be picked up at the pharmacy. 0950 - Vital signs BP 124/80, HR 69, Resp 16, Temp 98.1, O2 sat 97%, 0955 - Escorted to pharmacy to pick up medication. 1005 - Observed patient self-administer 25mg Benadryl by mouth, escorted patient to her office. Pt monitored for 2.5 hours - 1220 symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,MIL,"cymbalta, synthroid",None,"hypothyroid, fibromyalgia",,NKDA,"['Paraesthesia oral', 'Tongue disorder']",1,MODERNA,IM 926982,MT,29.0,F,"erythema, swelling, heat- increased to size of entire upper arm from shoulder to elbow",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,PVT,,,,,Morphine- seizures,"['Erythema', 'Skin warm', 'Swelling']",1,MODERNA,IM 926983,CA,43.0,F,"ED Note: This is a 43-year-old female with history of asthma who presents for evaluation of chest tightness. The patient is an employee and received her COVID-19 vaccine, first dose 20 minutes prior to ED arrival. She subsequently developed chest tightness and wheezing. She used he albuterol r inhaler and now feels improved. She says that she has been having increased asthma exacerbations lately because of the change in weather. She has had no prior allergic reaction to any vaccine. She denies any hives. Denies any throat tightness. Her symptoms at this point have resolved. Monitored in ED x 4 hrs. No treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"Albuterol, citalopram",n/a.,asthma,,Contrast dye- itchy,"['Chest discomfort', 'Condition aggravated', 'No reaction on previous exposure to drug', 'Wheezing']",1,PFIZER\BIONTECH,IM 926984,TN,47.0,F,"Tongue swelling, face felt funny, and throat pain. See above in report for times. Dexamethasone 10mg IM in clinic. Benadryl OTC as directed. Pepcid 20mg daily po x 7 days",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PUB,"Pt received COVID 19 Vaccine, Moderna 025L20A at Health Department Vitamin D2 10mcg po daily Levothyroxine Sodium 137mcg po daily",None noted,"ASTHMA , THYROID DISEASE, DIVERTICULITIS LEFT SHOULDER REPAIR, TORN LEFT AC/ SPURS, APPENDECTOMY, HYSTERECTOMY, THYROIDECTOMY, 09/2020 BLADDER SLING",,Codeine Keflex,"['Facial discomfort', 'Oropharyngeal pain', 'Swollen tongue']",1,MODERNA,IM 926985,MI,63.0,F,"Injection site soreness started the evening of the date the vaccine was given. Inflammation about the size of an avocado was noticed 24 hours after injection. Soreness and redness increased over the next 24 hours along with mild swelling. The redness started to improve 48 hours after injection, and it resolved about 60 hours post injection. No treatment was necessary.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Injection site erythema', 'Injection site inflammation', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 926986,MN,37.0,F,"Quarter sized, hard, swollen, warm to touch area to left arm at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PUB,None,None,None,,None,"['Injection site induration', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 926987,GA,16.0,F,Administered vaccine to a 16yr old,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,Outpatient Medications at End of Encounter on as of 8/4/2020 Disp Refills Start End Carbamide Peroxide (DEBROX) 6.5 % Otic Drop 15 1/1 11/25/2019 Sig - Route: USE AS DIRECTED 7 drop once day for 7 �min for 5 �days prior to ear cleaning -,"as of 8/4/2020 ICD-10-CM Priority Class Noted - Resolved ECZEMA L30.9 8/2/2013 - Present CONGENITAL BILAT FLAT FOOT Q66.51, Q66.52 8/15/2016 - Present",,,No known allergies,['Product administered to patient of inappropriate age'],1,MODERNA,IM 926988,WA,59.0,F,"Pt received .5ml Moderna vaccine in left deltoid at approximate 0915. At 0920 noticed tingling in lips, notified RN at 0930, also reported thickness of tongue. Pt denies difficulty swallowing, denies changes in heart rate/heart palpitations, denied difficulty breathing and dizziness. Pt calm but concerned of symptoms.0940 - Notified health care provider, completed patient assessment, ordered Benadryl 25mg p.o. to be picked up at the pharmacy. 0950 - Vital signs BP 124/80, HR 69, Resp 16, Temp 98.1, O2 sat 97%, 0955 - Escorted to pharmacy to pick up medication. 1005 - Observed patient self-administer 25mg Benadryl by mouth, escorted patient to her office. Pt monitored for 2.5 hours - 1220 symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,MIL,"cymbalta, synthroid",None,"hypothyroid, fibromyalgia",,NKDA,"['Paraesthesia oral', 'Tongue disorder']",1,MODERNA,IM 926989,FL,20.0,F,"Pain at injection site, chills, cough, sore throat, runny nose, congestion, headache, fatigue, nausea, delirium, chest pain for 4 days now.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Vitamin C and Vitamin D,None,None,,Bactria/Sulfa Drugs,"['Chest pain', 'Chills', 'Cough', 'Delirium', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Oropharyngeal pain', 'Respiratory tract congestion', 'Rhinorrhoea', 'SARS-CoV-2 test', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 926990,ND,29.0,F,"Numb tongue, cheek and lip. Felt puffy and slightly swollen. Airway and breathing maintained. Symptoms occurred ~25-30 mins after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,None,slight runny nose,No,,Sage and pollen,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Skin swelling', 'Swelling']",1,MODERNA,IM 926991,MA,38.0,F,"On Tuesday 1/5/2021 at 2:30 PM I started to feel my injection site become itchy. By 6:30 AM on Wednesday (1/6/2021) I started to have redness, warmth and swelling at the injection site which increased in area size though out the day. Today is 1/7/2021 and at this time the area has grown slightly and is still red, warm and swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,WRK,Daily Multivitamin,,,,NKA,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 926992,MN,32.0,F,Sore arm and loose stool 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,"Vitamin E, anti histamine",,,,Lactose,"['Diarrhoea', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 926993,MN,32.0,F,"Persist nausea, headaches, migraines, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/24/2020,23.0,UNK,Nexplanon,,,,Penicillin,"['Headache', 'Malaise', 'Migraine', 'Nausea']",1,PFIZER\BIONTECH,IM 926994,DE,35.0,M,"Light Headedness, Extreme Tiredness, Neck Muscle Aches",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,SEN,Melatonin,None,COVID Oct 2020. Still having SOB on exertion.,,None,"['Dizziness', 'Fatigue', 'Myalgia', 'Neck pain']",1,PFIZER\BIONTECH,IM 926995,IL,49.0,F,"12:14pm Received vaccine and returned to office after 15 minute observation period. 2:30pm developed headache, 3pm developed nausea, vomiting and dizziness, flushing of skin. Rapid Response called at 3:52pm and patient sent to Emergency Room at 4pm. VS on arrival were BP 144/105, HR 146, RR 22, T 97.9, O2 sat on Room air 98%. ED treatment included IV of 0.9NS (1L), EKG, IV Zofran 4mg, IV Benadryl 25 mg, IV Ativan 0.5mg, IV Compazine 10mg. Also had CT head.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Alprazolam, Furosemide, Hydroxychloroquine, Leflunomide, Levothyroxine, Lidocaine, Losartan, Melatonin, Potassium Chloride, Prednisone, Spironolactone,",none,"lupus, pituitary adenoma, fibromyalgia, hypertension, hypothyroid",,"Azathioprine (pancreatitis), Milnacipran (incr liver enzymes), Sulfa (rash), Methotrexate (nausea, vomiting), Savella (incr liver enzymes)","['Computerised tomogram', 'Dizziness', 'Electrocardiogram', 'Flushing', 'Headache', 'Nausea', 'Sinus tachycardia', 'Vomiting']",2,PFIZER\BIONTECH,IM 926996,OR,46.0,F,"Patient received 1st dose Moderna Vaccination at 1405, went to sit in observation area and began to feel lightheaded and faint within first few minutes. Escorted to cot to lie down at 1412. 1415 VSS: BP 140/82 HR: 98 steady, RR:18 98% on RA with no visual rash, or difficulty breathing. Pt. reported that she was rushing in to clinic to get the vaccination and was often hot, face flushed at this time though pt reported that this was her baseline. Reported that she continued to feel faint, ABC all within normal limits. VSS continued to be stable with no signs of trouble breathing. Pt remained A&Ox5. 1425: pt reported tingling in hands bilaterally. VSS remained stable, tingling grew stronger in left FA dissipated in the R FA. Pt reported that she continued to feel as if she was unable to sit up, that this would cause her to pass out and that this sensation came in waves. Pt. was monitored for 20 minutes prior to receiving 50mg IM Benadryl in LUA and Code Green was called. Patient taken to ED for further observation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,"Employee Reported that she had taken her regular medications for DM, HTN, along with Zyrtec and then a first time dose of Celebrex per PCP recommendation to prepare for her COVID Vaccination today.","none presently, unknown if any historical illness over the past month.","DM, HTN",Tetanus Vaccine as a child,"arrhthromycin, tentanus toxoid","['Dizziness', 'Feeling hot', 'Flushing', 'Paraesthesia']",UNK,MODERNA,IM 926997,CT,34.0,F,"developed redness and swelling at injection site 6 days after vaccination. Mild itching at site, denies pain at site of injection after initial discomfort on day of injection that resolved. Mild axillary discomfort noted on side of injection, physical exam not performed as this interview was conducted over telephone, patient does not report axillary swelling or palpable lymphadenopathy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/06/2021,6.0,PVT,no current medications,None,None,,No known allergies,"['Injection site discomfort', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Skin discomfort']",1,MODERNA,IM 926998,CA,60.0,F,"Began with itchiness at the injection site which shortly turned into a swollen and raised injection site, hot to the touch, then it got really painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/31/2020,4.0,WRK,No,No,No,,No,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 926999,AR,30.0,F,"5 minutes after vaccination patient reported heart racing and dizziness. Blood pressure and heart rate were checked. Both were elevated at 146/90 and 133. Patient told to take slow deep breaths. Blood pressure and heart rate checked 15 minutes later. They were lower than first reading, but still elevated. About 5-10 minutes later, patient stated her throat felt a little tight. Patient was given 50mg of benadryl 12.5ml/5ml. Nurse practitioner came from urgent care clinic connected to the pharmacy to evaluate. Patient was taken to a room at the urgent care to have vitals monitored and to lay in a supine position. Patients' vitals normalized, and patient was released around 5:05pm. Patient was given instructions to take benadryl later this evening from aprn, and to go to the er if any problems develop with breathing.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PHM,unknown,none reported,none reported,,none reported,"['Blood pressure increased', 'Dizziness', 'Heart rate increased', 'Palpitations', 'Throat tightness']",1,MODERNA,IM 927000,NH,36.0,F,"~15 minutes post vaccination patient began to have ""pins and needles"" originating in left arm and then moving to legs. Also states that she had sensation of feeling ""off balance"". This did not get worse with change in position or head movement. It progressed to feeling ""shaky"". VS were obtained and were HR of 68 and regular, BP of 134/82, RR of 14. Pupils PERL with normal EOM. Good tactile sensation bilaterally. Moving extremities with purpose. Skin color was initially normal but became pale while feeling shaky. Patient was placed in a near supine position in her vehicle and was observed 1:1. She was given apple juice which improved her shakiness and she regained color in face. She was able to get out of vehicle and ambulate without assistance with a steady, independent gait. She stated that she was back to her baseline before leaving.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,,,,,,"['Balance disorder', 'Nervousness', 'Pallor', 'Paraesthesia']",1,MODERNA,IM 927001,WI,27.0,M,"13:42 (7 minutes after vaccination) - developed lightheaded, BP75/26, HR 90, patient laid self to the floor 13:44 - BP 94/43, HR 48 - continue laid down 13: 48 - BP 111/60, HR 58 13:50 - 128/67, HR 81",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Vitamin D 5000 units daily Caffeine 200 mg daily,None,None,"at childhood, unknown types of vaccine, tolerated flu vaccine ok on recent years",None,['Dizziness'],1,MODERNA,IM 927002,CA,31.0,M,"Patient C/O flushed and feeling hot. vital signs at 1350 were BP= 130/81; P=83 ; R=16 ; T= 98.9. patient was observed for 20 minutes. At 1410, the patient was stable and stated that the symptoms have resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,None,None,None,,NKA,"['Feeling hot', 'Flushing']",1,MODERNA,IM 927003,NC,48.0,F,red rash began to appear at injection site approximately 3 days after injection; slightly itchy and hot to touch; lessened but still red and itchy currently,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/03/2021,5.0,OTH,"multi-vitamin, vitamin, Zyrtec, viscera",migraine,migraines,,sulphate,"['Injection site rash', 'Injection site warmth', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,SYR 927004,TX,48.0,F,"Site injection pain (days 1-3) 12/30/2020, Days 6-present (1/6/2021-present) nausea, dizziness/headaches, muscle pain, joint pain, arm weakness/unable to lift my arm, fatigue/tiredness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,WRK,"Losartan Potassium 50mg, Escitalprolam 20 mg, Xyzal 5mg, Flonase, Anastrazole 1mg, Multivitamin, Vitamin D, CoQ10, Glucosamine Chrondoitin, Olopatadine .1%",lymphedema R arm from breast cancer surgery and radiation treatment,"HTN, breast cancer (R), partial hysterectomy in 1/2020, radiation treatment 3/2020, lymphedema, anxiety, seasonal allergies/hay fever",,"Allergic to adhesive glue in tape and bandaids, pollen, dust, pet dander, grass, Atovastatin","['Angiogram', 'Arthralgia', 'Cardiovascular evaluation', 'Dizziness', 'Electrocardiogram', 'Fatigue', 'Headache', 'Injection site pain', 'Laboratory test abnormal', 'Mobility decreased', 'Muscular weakness', 'Myalgia', 'Nausea']",1,PFIZER\BIONTECH,IM 927005,IL,43.0,F,Temp 101. Chills,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"Lisinpril, Vitamin, Baby ASA",none,HTN,,NKA,"['Body temperature increased', 'Chills']",2,PFIZER\BIONTECH,IM 927006,SC,68.0,F,"Diffuse polyarthropathy starting the day after vaccination and continuing for 7+ days. Currently treating with abx for concern of possible cellulitis, and prednisone 60mg for polyarthropathy. Currently admitted.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,"clopidogrel, carvedilol, atorvastatin, aspirin, albuterol, torsemide, buproprion",None,"HFrEF, CAD, HTN, COPD, depression, OSA, ckd",,"latex, nickel","['Arthropathy', 'C-reactive protein increased']",1,PFIZER\BIONTECH,SYR 927007,NY,57.0,F,I have significant tenderness in my left arm pit. I cannot lie on that side to sleep and it hurts all day. I put warm compresses on it to no avail. It also appears to be a little swollen.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"zinc, vitamin D, multivitamin",NIL,NIL,,NIL,"['Axillary pain', 'Sleep disorder', 'Tenderness']",1,MODERNA,IM 927008,NC,47.0,F,"Sudden severe headache followed by severe joint pain (elbows, knees, neck and back) and axillary and left arm lymphedema and left breast swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,"Prevacid, duloxetine, requip, trazodone, vitamin b-12",None,"Depression/anxiety, adrenal adenoma",,"Sulfa, codeine, bees","['Arthralgia', 'Breast swelling', 'Headache', 'Lymphoedema']",2,PFIZER\BIONTECH,IM 927009,,46.0,F,"Hives on January 31st, took Benadryl. Hives from trunk, leg, and arms. Low grade fever (100) Fatigue entire time. On 1/5/21 arm was fine, on 1/7/21, approx. 3"" welt at the injection site (Right Deltoid). Fever continues.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,UNK,"Wellbutrin XL, Trazadone, Percocet discontinued on 12/31.",,,,Monostat,"['Fatigue', 'Injection site urticaria', 'Pyrexia', 'SARS-CoV-2 test negative', 'Urticaria']",1,MODERNA,IM 927010,CA,54.0,F,"Fever, chills, headache, dry cough, left calf pain, tremor in left thumb",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Chills', 'Cough', 'Headache', 'Pain in extremity', 'Pyrexia', 'Tremor']",1,PFIZER\BIONTECH,IM 927011,AL,68.0,M,"myalgias, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,"metoprolol, atorvastatin, apixaban, tricagalor",(none),atrial fibrillation,,(none),"['Malaise', 'Myalgia']",UNK,PFIZER\BIONTECH,IM 927012,ME,60.0,F,"On day 8 following vaccine, I noticed that the site of injection was red and raised. It had not been up t then. Red, raised area was about 2"" x 3"". No pain, no other symptoms. I massaged area in a hot shower. Also, had a headache in the middle of the night same date that was 5/10 pain and required 2 extra strength Tylenol-not normal for me. I called my PCP. She offered to see me, but did not require it. I chose not to be seen; I just wanted to make sure I wasn't overlooking something.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,PVT,"Vitamin D3 1,000; Zinc, 50 mg; Flax Seed Oil; stool softener 100 mg (2) x daily. ; benzoyl peroxide topical 10% (5)x weekly on face; clindamycin 1% (5)x weekly.",None.,childhood asthma,,sulfa drugs and amoxicillin; eggplant.,"['Headache', 'Injection site erythema', 'Injection site swelling']",2,MODERNA,IM 927013,ID,30.0,F,"The vaccinator reported: He administered the vaccine to the patient and as he withdrew the needle from patient's arm, there appeared to be liquid ""running down"" the patient's arm the vaccinator believed was vaccine. The patient reported this is very normal for her and confirmed this happens every time she receives a vaccination. Clinic staff were unsure if immediate re-does was appropriate. Staff did not immediately re-dose and contacted Moderna via phone for further instruction/recommendation. Initial Moderna representative indicated he would be unable to answer question regarding re-dose, and stated he would advance the question/situation to company patient safety division. Representative did explain it would most likely be some time before patient safety division returned contact. As of the time of this report, staff still has not heard back yet from Moderna. Staff explained the situation to the patient, advised her to monitor for any adverse reactions, and recommended contacting her PCP and staff is things worsened. Decision was made to maintain the patient's schedule for her 2nd dose until Moderna contacts staff to advise them of any other best next steps. Staff follow up with patient several times via phone call to inquire about any adverse reactions. The patient describes redness/soreness/warm to the touch at injection site, however states this is also normal following any vaccination administration. The patient did confirm she will follow up with her PCP after staff's last check-in phone call.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Incorrect dose administered', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Needle issue']",UNK,MODERNA,IM 927014,AK,72.0,F,"extremely stiff neck for 4 days; itching on back and shoulder area for 2-3 days, swelling of the eyes for 2-3 days; itchy rash on medial aspect of vaccinated arm for 2-3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,"lisinopril, metoprolol, timolol, nifedipine",,"acute angle-closure glaucoma, angiodysplasia of colon, hemorrhagic stroke, hypertension, myocardial infarction, vitamin D deficiency",,"erythromycin, azithromycin, multiple foodsac","['Eye swelling', 'Musculoskeletal stiffness', 'Pruritus', 'Rash', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 927015,MO,62.0,F,"Size of a quarter, red, warm to touch right below the inj site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,"Levothrone, Lexapro, Trazodone, Lorazepam, Vit D, C, calcium. Actonel.",no,"hypothyroidism, osteoporosis",,"Cephalexin, Amoxicillin, Mucinex, Azithromycin","['Injection site erythema', 'Injection site warmth']",1,MODERNA,SYR 927016,,33.0,F,Injection site redness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,PVT,none,none,none,,none,['Injection site erythema'],1,MODERNA,IM 927017,,45.0,M,Slight headache within 20 minutes of vaccine. Very sore arm pain radiating from injection site for 2days plus.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,OTH,,,,,,"['Headache', 'Injection site pain', 'Pain']",1,MODERNA,IM 927018,,45.0,F,Patient had a headache that did not prevent her from returning to work.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,None,None,None,,None,['Headache'],1,MODERNA,IM 927019,DC,46.0,M,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,Juluca,,HIV,,Sulfa,['Headache'],2,PFIZER\BIONTECH,IM 927020,CA,63.0,M,Injection site soreness that was worse over night Headache this morning that would not go away. Has been taking Ibuprofen and Tylenol and just now Tramadol in repeated doses for relief. Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Fatigue', 'Headache', 'Injection site pain']",1,MODERNA,SYR 927021,PA,76.0,F,"Patient immediately became flushed and hot. It lasted 5-10 minutes, returned to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,SEN,unknown,,,,unknown,"['Feeling hot', 'Flushing', 'Immediate post-injection reaction']",1,PFIZER\BIONTECH,IM 927022,NJ,63.0,F,"Patient complained of dizziness, was moved into a different room. Vital signs taken by on-site doctor. Cold compress provided. Pretzel and water given patient had not eaten today. At 10:10 reported feeling better. Patient left site with husband that was already at site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,,,,,,['Dizziness'],1,MODERNA,IM 927023,MN,36.0,M,On/Off Head Cold On/Off Hot/Cold Chills One Hour of the Runny Defecation. Loss of Apatite General Feeling of being Unwell,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,(None),(None),(None),,Allergic to peas and lentils.,"['Chills', 'Decreased appetite', 'Diarrhoea', 'Feeling of body temperature change', 'Malaise', 'Nasopharyngitis']",2,PFIZER\BIONTECH,SYR 927024,UT,44.0,F,"At day 8 post vaccine I have redness, itching and warm skin at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,PVT,"Lamictal, lithium, Seroquel, metformin, yasmin, Hair La Vie supplement",None,"Bi-polar 1, PTSD",,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,SYR 927025,,36.0,F,Patient began to feel itchy around scalp and neck. Patient never continued to throat or tongue issues but was given 25mg of Benadryl for prevention. She returned to work within 30 minutes with no continuation of symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,None,None,None,,None,['Pruritus'],1,MODERNA,IM 927026,TX,51.0,F,Nausea Chills Fever Body aches Severe Headache Low back pain Symptoms lasted 48 hours Treated the symptoms and stayed in bed,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PHM,"Benicar HCTZ Omeprazole Effexor Wellbutrin Singular Zyrtec Vitamin D, C, Zinc and Elderberry",None,Hypertension Asthma Allergies,,Cardizem,"['Back pain', 'Chills', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 927027,NJ,36.0,F,"Shortly after the patient was administered a first dose of Covid-19 vaccine at around 3:05 pm on 1/07/21, the patient experienced troubled breathing, chest tightness and wheezing for several minutes. The patient described her condition as, ""my throat feels like it is closing up."" An epipen was given at 3:12 pm and the patient reported improvements at 3:16 pm (four minutes after the epipen was given). Emergency services was called and reported to the scene at 3:12 pm where they noted the patients improved condition, after the epipen was administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,SEN,None Reoported,None Reported,Asthma,,None Reported,"['Chest discomfort', 'Dyspnoea', 'Throat tightness', 'Wheezing']",1,PFIZER\BIONTECH,IM 927028,NM,36.0,F,"Dizziness/woozy feeling almost immediately. Over the subsequent hour, she reported tingling in her face and side of her mouth. She had mild tachycardia around 99 bpm, BP of 132/88, respiration of 18, and O2 sat of 96 She also reported slight difficulty swallowing. No hives, rash, or any obvious facial swelling. She received 50 mg IM diphenhydramine about 45 minutes after she was vaccinated. Her tachycardia improved after the injection. She was sent to the local ER for observation and went home three hours later without additional incident. She slept through the night and is reportedly more or less back to normal today.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,SEN,Unknown,None known,None known,,None,"['Dizziness', 'Dysphagia', 'Immediate post-injection reaction', 'Paraesthesia', 'Paraesthesia oral', 'Tachycardia']",UNK,MODERNA,IM 927029,PA,44.0,F,Arm pain - day 2 through 4 Lymphadenopathy left neck - day 5 and contiues Shoulder Ache - day 5 and continues,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,WRK,"Norethindrone 2.5mg daily, Zyrtec 5mg daily, Flonase 2 sprays each nostril daily",None,None,,"Morphine (vomiting), Chocolate","['Arthralgia', 'Lymphadenopathy', 'Pain in extremity', 'Ultrasound scan']",1,MODERNA,IM 927030,IL,26.0,M,"Redness and harden area to injection site,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,"Omeprazole, Nuvigil, Krill oil, Hydrochlorthiazide",None,none,,NKA,"['Injection site erythema', 'Injection site induration']",1,MODERNA,IM 927031,UT,23.0,F,"Skin itching, dizziness, nausea and lump in throat. Not anaphylactic reaction. Rest, Benadryl and claritin OTC and she was back to normal after 1 hour and monitored another hour before leaving.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,"Zoloft, Omeprazole, Trazodone",none,"Gerd, Depression, Recent Covid infection, food allergies",,"Levocetirizine, fruit and veggie allergies","['Dizziness', 'Nausea', 'Pruritus', 'Sensation of foreign body']",1,MODERNA,IM 927032,KY,62.0,F,Fever 104.8 for 24 hours Bone pain for 24 hours Dizziness Injection site pain continues,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Zoloft Valtrex Norvasc Estrace Provera Mevacor,None,Hypothyroidism Depression Hypertension,,Sulfa Penicillin,"['Bone pain', 'Dizziness', 'Injection site pain', 'Pyrexia']",1,MODERNA,IM 927033,OR,46.0,F,"Had vaccine and felt ill for the rest of the day. Woke up on 12/31 and had a fever and felt achy. On 1/1/21, had hives on arms, legs, and trunk. Took benedryl and by 1/3/2021, the hives subsided. Continued to have a low grade fever of (100) and still felt achy. On 1/5/2021, arm felt fine, but still had a fever. Work up on 1/7 and now has a red welt at the injection site that is hot to touch and is about 3 inches in diameter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,"Wellbutrin, Trazadone. Recently took percocet for a rib fracture.",None,None,,Monostat,"['Injection site rash', 'Injection site urticaria', 'Injection site warmth', 'Malaise', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Urticaria']",1,MODERNA,IM 927034,OH,58.0,M,"Woke up at midnight with severe body aches, headache, stomach ache, diarhea,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,Gabapentin; Viibryd; Propranolol; Verapamil; Lorazepam; Atorvastatin; Trazodone; Hyoscamine; Quetiapine; Nexium; Sumatriptan,None,Anxiety; Depression; Migraine,,morphine,"['Abdominal pain upper', 'Diarrhoea', 'Headache', 'Pain']",UNK,MODERNA,IM 927035,NV,35.0,F,"1 week post vaccination I received a routine allergy immunotherapy injection. Just prior to the immunotherapy vaccination site was noted to have hardened area(less than 1in). 30 minutes post immunotherapy vaccination site was noted to be swollen, hardened area was larger(2inches), hot to the touch. For the rest of the evening I was fatigued and had a headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,MIL,"Ibuprofen, Vitamin D, Flonase, Sudafed, Singulair, Zyrtec, Omeprazole, Orilissa",,"Endometriosis, environmental allergies, GERD",,"Sulfa, Levaquin, Latex, Artificial Cinnamon","['Condition aggravated', 'Fatigue', 'Headache', 'Injection site induration', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 927036,KS,34.0,M,"Body aches overnight then a spell of dizziness, nausea and almost fainting and sweating profusely around 9:30am the following day. Continued body aches and headache for remainder of the day.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,"Fish oil, vitamin D, Metamucil fiber",None,None,,None,"['Dizziness', 'Hyperhidrosis', 'Nausea', 'Pain', 'Presyncope']",2,PFIZER\BIONTECH,SYR 927039,CA,24.0,F,Patient complained of dizziness and fatigue during 20 minute post injection monitoring period. She had elevated BP 183/90 and HR 102. Paramedics were called and she was transferred to the hospital for further evaluation.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,SEN,HTN medication,Unknown,Unknown,,Unknown,"['Blood pressure increased', 'Dizziness', 'Fatigue']",1,PFIZER\BIONTECH,IM 927040,TX,23.0,F,"On day of injection: axillary tenderness, resolved. 1 week after injection (1/7/21): redness, swelling, and warmth over site of injection, ongoing",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,OTH,Women's One-a-Day Cranberry supplement,no,no,,no,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Tenderness']",1,MODERNA,IM 927041,PA,27.0,M,"Fever as high as 101.6, body aches, severe pain at injection site, convulsions/chills, nausea, cough, migraine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,Lamotrigine 75mg daily,,,,,"['Chills', 'Cough', 'Injection site pain', 'Migraine', 'Nausea', 'Pain', 'Pyrexia', 'Seizure']",1,PFIZER\BIONTECH,SYR 927042,UT,23.0,F,"10 minutes after receiving vaccine she began to feel itchy, dizzy and nauseas. She also had a lump in her throat but did not have respiratory distress. She was placed in supine position and monitored. She was given oral benadryl and Claritin and by 45-1 hr was feeling better. By 2 hours she was feeling normal and allowed to leave",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,"zoloft, trazodone, omeprazole",Covid 19,"Depression, Gerd, food allergies",,"xyzal, food-fruit and veggies","['Dizziness', 'Nausea', 'Pruritus', 'Sensation of foreign body']",1,MODERNA,IM 927043,NJ,55.0,F,"Received the Moderna COVID-19 vaccine EUA on 12/27/2020, the next day my arm was sore and red. Had minor muscle aches of my shoulders and neck. This went away by the second day. No more symptoms until the 8th day after injection (1/4/2021). Woke up in the morning with injection site swelling, itching, redness, arm pain, and minor sore throat which lasted 24-48 hours. No treatment was needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,01/04/2021,8.0,PVT,Vitamin D Osteo-Biflex Vitamin C,,,,Penicillin,"['Erythema', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Myalgia', 'Oropharyngeal pain', 'Pain in extremity']",1,MODERNA,IM 927045,WA,61.0,F,"1/4 2pm stuffy sinuses/slight nausea, injection site hard, increased warmth, sore. 8pm - feeling very cold, intense chills and shaking by 10pm, temp 99.8, 100.4 @ midnight. Started dosing with 1000mg Tylenol q 6hours ATC. 1/5 6am - temp 102.8, cont with Tylenol. Temp never below 100.8 all day, slept a lot. Noted white circle around injection site, redness extending down deltoid, edema and firmness. 6 pm - temp at 102.3, by 9 pm finally feeling temp ?break? (started perspiring). 11 pm - temp at 99.9. 1/6 7 am temp at 100.6, injection site/arm still red but not as painful and is itchy now. 1 pm - temp at 98.9. Stopped taking Tylenol. 11 pm - temp 100.3. 1/7 8 am - temp 98.4 and have remained afebrile. L arm with decreased soreness, still red and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"1000mg calcium citrate QD, 125mcg D3 QD, 100mcg K2, QD, ES Hair, Skin and Nails - 3 capsules QD, AREDS 2 - 2 capsules QD, Melatonin 5 mg nightly, 1000mg Tylenol BID",No - but please note I was COVID + on 10/19/2020,None,,"NKDA, no food allergies, allergy to nickel","['Body temperature increased', 'Chills', 'Erythema', 'Feeling cold', 'Injection site erythema', 'Injection site induration', 'Injection site oedema', 'Injection site pain', 'Injection site warmth', 'Nasal congestion', 'Nausea', 'Pain in extremity', 'Pruritus', 'Tremor']",1,MODERNA,IM 927046,MO,61.0,F,"Injection was given to me on 12/29/20. On 1/6/21, I noticed a small red area, under the bruise from where the injection had been given. It was about 2 inches by 3 inches in size. On 1/7/21, the area has increased in size - it's about doubled in size. No itching. It's soft. It is warm, but not hot.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,WRK,"Metformin, Valterx, Calcium, Vitamin D3, MVI, Vitamin B12, Melatonin, Mg+",none,"impaired fasting glucose, Herpes type 2, controlling outbreaks with daily 500mg Valtrex History of Hormone Positive Breast Cancer, in 2006.",,"Sulfa, Lodine, Adhesive, Nickel","['Injection site bruising', 'Injection site reaction', 'Injection site warmth']",1,MODERNA,IM 927047,TX,30.0,F,"Patient reported felt injection site was red, hard, painful and itchy 8 days after injection. She was seen by her provider and he ordered her antibiotic Augmenten which she has not yet picked up from pharmacy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,WRK,None,HTN,HTN,,None,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,IM 927048,HI,31.0,F,12-13 hours post injection experienced low grade fever (100 degrees) chills and body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Oral birth control Apri,None,None,,Codeine,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 927049,MD,37.0,F,"Redness, swelling, welt, and warm to touch about 1 inch radius from injection site, more swelling located medial to injection site. It went down after about 3 days, and then on 1/7/21, I woke up with pain at the injection area and redness again. Around 3:30/4pm that same day, my arm had even more redness and swelling than the day after the shot and was hot to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,01/01/2021,31.0,OTH,"Vit D, B12, women daily vitamin.",None,IBS,,NKA,"['Erythema', 'Injection site erythema', 'Injection site pain', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Peripheral swelling', 'Skin warm', 'Urticaria']",1,MODERNA,IM 927050,TX,24.0,F,"12 hours of chills, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Chills', 'Headache']",2,PFIZER\BIONTECH,IM 927051,IN,46.0,F,Swollen knot about the size is a silver dollar at the injection site that lasted 3 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/07/2021,4.0,UNK,None,None,None,,Neomycin,"['Injection site nodule', 'Injection site swelling']",1,PFIZER\BIONTECH,SYR 927053,HI,31.0,F,Fever to 102.7F Rigors Nausea Myalgia All began morning after second vaccine and worsened throughout day,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,None,None,None,,Sulfa and Zithromax antibiotics (hives),"['Chills', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 927054,CA,40.0,F,"Eight days after the vaccine, I experienced a rash and swelling at the site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,WRK,"B Complex, Vitamin D3",none,none,,none,"['Injection site rash', 'Injection site swelling']",1,MODERNA,IM 927055,CA,73.0,F,"Itchy, bump, red, got bigger swollen, hard. Arm pain. Was given doxycycline.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,PVT,"Coreg, 12.5mg, Plavix75mg, Crestor5mg.",no,no,,no,"['Erythema', 'Induration', 'Pain in extremity', 'Pruritus', 'Swelling']",1,MODERNA,SYR 927056,AR,87.0,F,"Malaise, diarrhea, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,"Hydrocodone, antibiotics, heart medication",None,,,Penicillin,"['Diarrhoea', 'Malaise', 'Nausea']",1,MODERNA,SYR 927057,OH,28.0,F,"December 30- received shot: soreness in arm. December 31- Nightmares, suicidal thoughts, hearing voices, January 1- unable to stay awake slept entire day/night January 2- dizzy, nausea and vomiting, diarrhea, body aches, muscle spasms. 24 hours January 3- Weak and sore, I went to rapid care on the 2nd, they did a rapid covid test -negative, stated that it was possibility from the shot. I then received 1000 ml of fluid iv and 4mg Zofran IV push.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,Lo Loestrin Fe allegra vit d 3 paxil metformin atarax,none,"depression, anxiety, Pre diabetic",,Lactose Intolerant Sulfa,"['Asthenia', 'Diarrhoea', 'Dizziness', 'Hypersomnia', 'Muscle spasms', 'Nausea', 'Negative thoughts', 'Nightmare', 'Pain', 'Pain in extremity', 'SARS-CoV-2 test negative', 'Vomiting']",1,MODERNA,IM 927058,WI,56.0,F,"Globus sensation in throat, was better the next day and gone on the day after",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/19/2020,2.0,WRK,"Losartan HCTZ, fish oil, garlic, calcium, multivitamin",None,"Back pain, hypertension",,Amlodipine,['Sensation of foreign body'],UNK,PFIZER\BIONTECH,SYR 927059,IN,26.0,F,Sore arm for about 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,"Effexor, Apri",,,,oxycodone,['Pain in extremity'],1,MODERNA,SYR 927060,CT,57.0,M,"Fever 100.8, headache, chills, injection site pain, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,AM HCTZ -25 mg ASA 81 mg Losarten-100 mg Cardizam 120 mg Famotidine (Pepcid) 40 mg B12 5000 mcg Alpha Lipoic Acid 200 mg Chromium 800 mcg Vitamin C 1000 mg Folic Acid 800 mcg DHEA 50 mg X-Clear Nasal spray (Saline and Xyletol) TID QID P,None,"Bicuspid Aortic Valve, Aortic Aneurysm without dissection, Seasonal Allergies, GERD, HTN",,NKDA,"['Chills', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 927061,CA,47.0,F,Patient C/O burning in the ear. systolic BP ranging between 176 and 200; Diastolic BP ranging between 100 and 118. Paulse ranging between 79 and 81.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,Metoprolol 25 mg daily,Unknown,Hypertension,,NKA,['Ear discomfort'],1,MODERNA,IM 927062,CA,49.0,M,"pain at injection site, low grade fever 99.8, headache, chills, joint pan, fatigue/exhaustion all started about 24 hours after receiving vaccine, took Tylenol. felt better next day, still soreness at injection site but other symptoms improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"Daily multi-vitamin, Goli apple cider vinegar gummy supplement, 500mg vitamin C","Tested positive for Covid on December 9, 2020",None,,Lactose intolerant,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pyrexia']",1,MODERNA,IM 927063,CA,60.0,F,"Measured today 6cmX6cm swelling, redness, warm at injection site, reports itchy woke up with the follow day 12/29/20. Called clinic due to concern it has been a week and site still irritated. Recommended cold pack to arm will follow up on Monday 1/11/21. No other complaints.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,Vit-D3 2000units daily Hydrocodone/Acetaminophen 10mg/325mg Baclofen 10mg PRN,None,Low Back Pain Vit D3 deficiency,,Sulfa Drugs Celebrex,"['Injection site erythema', 'Injection site irritation', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 927064,TX,29.0,F,"Onset of chills at around 10pm (normal temperature). Early morning around 4am on 1/3/2021 I was woken up by severe arm pain (arm injected) and generalized body aches. Around 7am 1/3/2021 my temp was 99.7. Around 10am my temp rose to 100 and all morning I had chills. Chills and fever subsided after Tylenol but then I started having chills again around 3pm with my temp raising once again to 99.8. The whole day I also had a headache, generalized body aches, looked flushed, had moderate arm pain on arm injected. When I woke up on 1/4/21 all symptoms were gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,Synthroid 88mcg daily taken at 5am same day,,Hypothyroidism,,Penicillin,"['Body temperature increased', 'Chills', 'Flushing', 'Headache', 'Injection site pain', 'Pain']",1,MODERNA,IM 927065,MS,39.0,F,"woke up with fever and sore throat on 22nd; went to job and got tested and tested positive; on the 23rd developed right upper lobe pneumonia; on 27th was hospitalized with three lobe pneumonia; On 22nd received got zpack - azithromycin and sudafed; received at hospital doxicycleln IV ; ivermectin and went home with them, as well. Hospital",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,Flecinide 100 mg/day,none,vitriol fibulation,,none,"['Chest X-ray abnormal', 'Computerised tomogram normal', 'Laboratory test abnormal', 'Oropharyngeal pain', 'Pneumonia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 927066,IA,56.0,F,"Started with muscle aches and weakness in the right arm on Jan 7th, this afternoon I have a red lacy rash all down my arm a little itchy. Headache and lips tingle .",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,OTH,"losartan, insulin, vitamin D, Trimethoprim Wellbutrin ,",,"Diabetic, asthma",,"Environmental allergies , black walnuts","['Headache', 'Muscular weakness', 'Myalgia', 'Paraesthesia oral', 'Pruritus', 'Rash erythematous']",1,PFIZER\BIONTECH,IM 927068,FL,46.0,F,Within 5 minutes had pulse 160 and bp 180/100; five minutes after receiving the Moderna vaccine. The reaction lasted about 15 minutes and resolve without any medication or intervention. Reports she ?felt like garbage ?the rest of the day. Local medics are saying that this was an anaphylactic reaction and are refusing to offer the second vaccine dose . Patient states she felt more like an ?adrenaline dump? or maybe an ?infusion reaction?,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Thyroid supplements,Hypothyroidism,Remote allergic rhinitis treated with allergen immunotherapy,,,"['Anaphylactic reaction', 'Feeling abnormal']",1,MODERNA,IM 927069,UT,19.0,F,"Clammy, dizzy, nauseas, left arm pain and numb throat. She was monitored on exam table and she rested and was given Benadryl and Claritin and started to feel better by 45-60 minutes. By 2 hours she was completely normal and cleared to leave.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,none,none,none,,none,"['Cold sweat', 'Dizziness', 'Nausea', 'Pain in extremity', 'Pharyngeal hypoaesthesia']",1,MODERNA,IM 927070,OR,27.0,F,"Pt c/o hot flush and racing heart rate, BP was 132/78, P 86, R 18. Pt denied SOB, throat tightness, swelling of lips or tongue, nausea. HR was regular but became irregular after a few minutes. Pt transported to emergency room for treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,unknown,unknown,unknown,,"raw honey, bee stings","['Heart rate irregular', 'Hot flush', 'Palpitations']",1,MODERNA,IM 927071,IL,40.0,F,"On Monday January 4th I received my Covid-19 vaccine at work, at 410pm. That evening went uneventful. The following day, Tuesday January 5th I woke up with a sore right arm and a slight headache. The headache increased in intensity throughout the day, developing also body aches and a fever of 100.4. The symptoms seemed to improve slightly after taking Tylenol. The next day, Wednesday January 6th I felt much better, the body aches were almost gone, I had no fever and no headache. When I got home from work I noticed hives all over my arms, anterior and posterior neck - going into the hairline, face, especially around my mouth, chest, abdomen, upper and lower back. The affected areas were itchy and I also felt a slight burning/stinging sensation on my neck. Even though I did not notice any hives on my legs, my right ankle was itchy, as well. I took Claritin 10 mg and I did not notice much difference. When I woke up today, Wednesday January 7th the hives were still present on my arms, chest, abdomen and back and they looked like dissipating. It is currently 6:12 pm on January 7th and my hives are almost gone",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,SEN,"Vitamin C 1000 mg daily, Zinc 50 mg daily, Magnesium Glycinate 665 mg daily, Vitamin D3 5000 units daily, N-Acetyl-L- Cysteine 600 mg daily",None,None,,None,"['Burning sensation', 'Headache', 'Pain', 'Pain in extremity', 'Pruritus', 'Pyrexia', 'Urticaria']",1,PFIZER\BIONTECH,IM 927072,CT,27.0,F,"Delayed raised, red inflamed hive at injection site about 2 inches in diameter. Developed 8 days following injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,SCH,Escitalopram,N/a,Migraines,,None known,"['Injection site erythema', 'Injection site inflammation', 'Injection site swelling', 'Injection site urticaria']",1,MODERNA,IM 927073,NY,31.0,F,"Significant arm pain at site of injection starting at 5pm. Then developed vague aching throughout lower back, shoulder, and hips. Progressed to shooting pains (mild) into both legs and down both arms into fingers and toes. muscle aches and pains persisted until 4pm on 1/7. Also developed inflamed lymph node under left arm pit.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,None,None,,None,"['Arthralgia', 'Back pain', 'Injection site pain', 'Lymphadenopathy', 'Myalgia', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 927075,TX,22.0,F,"received 2nd dose of Pfizer COVID-19 vaccine @ 1355. At approximately 1630 began to feel heart racing and lightheaded. Hear rate in 130's without exertion. Patient walked over to the ED, heart rate when up to 170's and patient was treated in ED and discharged at approx. 2200.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Olly Women's Multi-vitamin,was treated by emergency room for adverse event and was diagnosed with a UTI during visit.,no,,NKA,"['Blood test', 'Dizziness', 'Electrocardiogram', 'Palpitations', 'Urine analysis']",2,PFIZER\BIONTECH,IM 927076,MA,26.0,M,"At 4:00pm the patient became anxious immediately after receiving the COVID-19 Moderna vaccine and after a minute of being observed he complained of sweats, feeling feverish, light headedness, muffled hearing. seeing spots and sudden urge to urinate. Blood pressure was 132/80 at time of event. Immediately he was given Gatorade and water and visibly became less diaphoretic and anxious after five minutes. By 4:20 pm the patient stated he was feeling ""back to normal"" and was assessed by a physician and was released after 30 minute of observation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,SCH,Unknown,"No illness at the time of vaccination, unknown prior history",Unknown,,No known allergies,"['Anxiety', 'Dizziness', 'Hyperhidrosis', 'Hypoacusis', 'Immediate post-injection reaction', 'Micturition urgency', 'Pyrexia', 'Visual impairment']",1,MODERNA,IM 927077,IN,34.0,F,"Fever, headache, sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,,,,,,"['Headache', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA,IM 927078,WA,34.0,F,"Fever, chills, tiredness, swollen lymph node (under armpit), upset stomach. This all occured after 10pm the day of the shot",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,pencillian,"['Abdominal discomfort', 'Chills', 'Fatigue', 'Lymphadenopathy', 'Pyrexia']",2,PFIZER\BIONTECH,IM 927079,IL,28.0,F,"She does note that she received the 1st dose of the Moderna vaccine earlier at about 0830 on 1/7. Patient reports that approximately 1-2 hours PTA in the ED, she began experiencing pain in her right wrist that has progressively worsened. She denies injury to the area and was not doing anything in particular when the pain 1st began. She states that she has not been sleeping any differently than usual. She denies a history of wrist pain or injury. She has not yet taken anything for the pain, but reports that is severe and present on the thumb side of her right hand over the pad and on the wrist. She does also have numbness in the right hand on both sides of the thumb and on the pointer finger as well as the area between the 2 digits on her hand. She states that she has a slight tingling sensation in her other fingers, but it is not numb. She states that she has trouble moving at her wrist and her thumb and pointer finger, but thinks it is because she is having so much wrist pain. She has not been experiencing any other symptoms. Patient also had 2 episodes of emesis in the ED. She was mildly tachycardic and had numbness to light touch and pinprick over the index finger and thumb on her right hand; also had weakness on flexion/extension at the wrist and index finger/thumb. She was ultimately given some IVF, diphenhydramine, methylprednisolone, famotidine, ketorolac, and fentanyl.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,"Acute pain of right shoulder Bifid uvula BMI 40.0-44.9, adult (HCC) Borderline personality disorder (HCC) Controlled substance agreement signed GAD (generalized anxiety disorder) Gastroesophageal reflux disease with esophagitis High serum thyroxine (T4) High serum triiodothyronine (T3) History of nonepileptic seizure Hypertension Hyperthyroidism Low TSH level Palpitations Persistent depressive disorder Postablative hypothyroidism PTSD (by history) Scoliosis Tachycardia Thyroiditis, acute �Scoliosis Bifid uvula - 3/1/96 Depression - 4/14/2008 Bulimia - 4/14/08 Acne - 4/23/08 ABO incompatibility reaction - 1/8/93; 1/7/93 OM (otitis media) - 2/1/98; 1/1/98; 5/28/97; 6/13/94; 4/30/94; 1/19/94; 12/30/93; 12/6/93; 11/8/93; 10/25/93; 10/4/93 Varicella - 5/96 Seborrheic dermatitis - 6/13/94 Lice - 1/23/95 Pericardial effusion - 10/21/2008 Kidney stone UTI (urinary tract infection) Postoperative nausea and vomiting Hyperthyroidism MYRINGOTOMY - 2/16/94 URETEROSCOPY - 7/23/2012 URETEROSCOPY - 8/8/2012 SHOULDER SURGERY",,"sumatriptan, escitalopram","['Arthralgia', 'Blood magnesium', 'Electrocardiogram', 'Full blood count', 'Hypoaesthesia', 'Metabolic function test']",1,MODERNA,IM 927080,MA,26.0,F,"The injection site is bright red, swollen, hot to the touch, itchy, and feels hard. There is some pain in the area and it hurts to lift my arm, and underneath in the armpit region. This is the first day this has happened since getting the injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,WRK,"Daily vitamins, Apri birth control, omeprazole",Anemia and eczema,Anemia and eczema,,"Sulfa meds, nickel, seasonal allergies, and some unknown contact allergies have appeared over time","['Axillary pain', 'Injected limb mobility decreased', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 927081,CA,49.0,F,9 x 5 cm area of raised redness and pain left arm starting on on day 8,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,"Duloxetine, estrogen, progesterone",None,None,,None,"['Pain in extremity', 'Rash erythematous', 'Rash papular']",1,PFIZER\BIONTECH,IM 927082,OH,39.0,F,"Fever 101.1, headache, muscle soreness for 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,Gabapentin 300mg 1 capsule a day,"COVID19 - symptoms started on 2020.12.21, positive test on 2020.12.23",none,,NKA,"['Headache', 'Myalgia', 'Pyrexia']",,MODERNA,ID 927083,FL,43.0,F,"I received my first vaccine dose (Modern) on Monday 12/28/20, and by Saturday morning 1/2/21 I woke with severe axillary lymph node swelling and soreness on the same side as the vaccine injection ( they were swollen to about softball size). The injection site was also very red, raised, itchy, and hot to the touch. By Monday morning 1/4/21, nothing had changed taking ibuprofen and I consulted with a female GI doctor I work for. She recommended that I see me PCP. I was able to get in that same morning to the PA, and she called the Dr for further consultation after examining me. He advised not getting the second dose of the vaccine and prescribed mthyprednisolone (medrol) 6 day pack.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,WRK,Escitalopram20mg daily Vitamin D 2000units daily Vitamin B12 2000mcg daily,,,,NKA,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 927084,OH,27.0,F,"Adverse reaction 7 days after vaccine: 1"" diameter hard lump at vaccine injection site, no itching, slight warmth to touch after I massaged shoulder. No adverse reactions up to this point beyond slight tenderness at injection site for the 24 hours after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PUB,Ibuprofen 400mg 2 hours prior to vaccine,No known,Obesity,,Occasional allergy to bananas (mild angioedema),"['Injection site induration', 'Injection site mass', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 927086,,16.0,F,Moderna vaccine given to patient under the age of 18.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Product administered to patient of inappropriate age'],1,MODERNA,IM 927087,MI,52.0,F,"12/22 vaccination. Felt fine. Arm sore 12 hours 12/26 - sudden sharp pain in chest, palpitations. HR irregular. waiting 15 min. Went to the ER. Frequent PVCs; occasionally over the years. Discharged home. Not sure if related to vaccine as under a lot of stress.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/26/2020,4.0,PVT,"Xeljanz 5mg 2x daily; Xyzal 5 mg 1xday; vit d3, calcium supplement; aimovig 1/month",,"rheumatoid arthritis, migraines, asthma",,"suptra, bacitracin","['Chest pain', 'Electrocardiogram', 'Heart rate irregular', 'Pain in extremity', 'Palpitations']",1,PFIZER\BIONTECH,SYR 927088,ID,55.0,F,"within 10 minutes of receiving vaccine pt complained of itchiness on and around injection site, no swelling or redness so we gave Benadryl 25mg and pt was fine afterwards. monitored after for 30 minutes with no issues",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,SEN,,,,,latex,['Injection site pruritus'],1,PFIZER\BIONTECH,IM 927089,OR,28.0,M,"01/06/2020 Patient complained of dizziness 45 minutes after vaccination, resolved in 15 minutes 01/07/2020 Patient complained of Headache, dizziness, nausea onset at 0400.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,Unknown,Unknown,unknown,,Unknown,"['Dizziness', 'Headache', 'Nausea']",1,MODERNA,IM 927090,CO,29.0,F,"Next morning, I woke up with severe positional headache (headache with standing or sitting up, resolved completely with ibuprofen and tylenol within 20 minutes). The next morning I also had a sore left deltoid, and soreness extending into my left chest and shoulder, which diminished throughout the day after ibuprofen and tylenol. I also had a left swollen armpit, which I interpreted as swollen lymph nodes. My left armpit was sore and was visibly swollen compared to the right. The left lymph node is still visibly swollen as I report this (approximatley 36 hours after vaccine administration), and is sore but less sore than initially. Of note, when I received the first vaccine in this series, my left deltoid was more sore than with the second administration, but soreness was limited to the deltoid and resolved within 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"prenatal vitamin, calcium",no,no,,NKDA,"['Axillary pain', 'Lymphadenopathy', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 927091,CA,43.0,F,Rash over my back /neck/torso . Fever /body aches /left lower abdominal pain and cramping /diarrhea /lower back pain /headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Albuterol inhaler,,Asthma,,,"['Abdominal pain', 'Abdominal pain lower', 'Back pain', 'Diarrhoea', 'Headache', 'Pain', 'Pyrexia', 'Rash']",2,PFIZER\BIONTECH,IM 927092,TN,34.0,F,"Next morning after shot. Red, hot to touch, arm soreness, fatigue. Next morning arm burning, swollen, itchy. Temp 99.8.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PUB,"Multi vitamin, baby aspirin, Ferosul 1 every other day, Drisdol 1.25mg 1x/wk.",strep throat.,"connective tissue disorder unsp, lupus anticoagulant disorder. Vitamin D dif. iron dif.",Flu,penicillin,"['Body temperature increased', 'Burning sensation', 'Erythema', 'Fatigue', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Skin warm']",1,MODERNA,SYR 927093,FL,51.0,F,"CELLULITIS OF THE LEFT ARM, REDNESS, AND WARMTH PT TOOK IBUPROFEN AND USED ICE PACK",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,WRK,IBUPROFEN,NONE,NONE,,NONE,"['Cellulitis', 'Erythema', 'Skin warm']",1,MODERNA,ID 927094,UT,75.0,F,Much itching and rash on upper and lower back,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,"Excedrine, Sudafed, synthroid, calcium citrate, vit. D, vit.C, D mannose",Urinary tract infection,"Arthritis, and osteoporosis Inflammatory bowel disease, Many allergies, Interstitial cystitis",Flu vaccine,"Sulfas, penicillins, most antibiotics, and pain medicines, dairy, nuts, all fish, citrus, soy, corn, beef, pork","['Pruritus', 'Rash']",1,MODERNA,IM 927095,FL,64.0,M,"2 weeks post-vaccination acute onset of headache, body aches, abdominal pain, and severe chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/06/2021,13.0,PVT,Celebrex Losartan Rosuvastatin Welbutrin Tamsulosin Tylenol,,Arthritis Seasonal allergies HTN Depression,,,"['Abdominal pain', 'Chills', 'Headache', 'Pain']",UNK,MODERNA, 927096,MA,60.0,M,"Day 2 (12/29/20): Fever (<100 degrees), Mild muscle aches, Fatigue Day 3 (12/30/20): Fatigue, Muscle aches Day 4 (12/31/20): Alternating chills and profuse sweating starting at 8am, Full body flushing, Grand Mal Seizure at 4:30pm",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,Venlafaxine 150mg daily Ibuprofen 600mg 2x/week,None,Mild osteoarthritis,,,"['Blood test', 'Chest X-ray', 'Chills', 'Computerised tomogram abdomen', 'Computerised tomogram head', 'Computerised tomogram thorax abnormal', 'Echocardiogram', 'Fatigue', 'Flushing', 'Generalised tonic-clonic seizure', 'Hyperhidrosis', 'Legionella test', 'Magnetic resonance imaging brain', 'Myalgia', 'Pulmonary embolism', 'Pyrexia', 'SARS-CoV-2 test', 'Scan with contrast', 'Streptococcus test', 'Ultrasound abdomen']",1,MODERNA,IM 927097,,41.0,F,Arm soreness and weekends 20-48hrs after vaccine. Fatigue 24 hrs after vaccine. Prolonged migraine 3-5 days after vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,UNK,,,,,,"['Fatigue', 'Migraine', 'Pain in extremity']",1,MODERNA,SYR 927098,IL,55.0,F,"Patient complained of palpitations 30 minutes after receiving the COVID19 vaccine. She had this same reaction after the first dose. She felt her heart racing and throat closing with chest pain. She received diphenhydramine 25 mg IV, famotidine 20 mg IV, and methylprednisolone 80 mg IV.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Metoprolol succinate, hydrocodone/acetaminophen, diphenhydramine, ascorbic acid, aspirin, atorvastatin, cyclobenzaprine, lisinopril/hctz, melatonin, multiple vitamin, nucynta",None,"SVT history, HTN, HLD, CAD, RSD, GERD",Increased heart rate and blood pressure. Throat swelling with first dose of COVID19,"Erythromycin, amlodipine, augmentin, diltiazem, codeine, contrast, gentamicin ointment, hydralazine, lyrica, nitrofurantoin, clopidogrel, nifedipine, trandolapril/verapamil, tramadol","['Chest pain', 'Palpitations', 'Throat tightness']",2,PFIZER\BIONTECH,IM 927099,,47.0,F,"Large localized reaction at injection site. Pain, swelling, redness, lumps under the skin and intense itching lasting for just over 1 week and unresolved but slowly improving. Initial reaction was approximately 10 cm in diameter and lasted for 5 days. Current reaction is approximately 5 cm but itching is worsening.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"ESCITALOPRAM, IBUPROFEN, ALBUTEROL, CYANOCOBALAMINE","ASTHMA, PERNICIOUS ANEMIA, DEPRESSION","ASTHMA, PERNICIOUS ANEMIA, DEPRESSION",,"PENICILLIN, ERYTHROMYCIN, TETRACYCLINE, SULFA, BENADRYL, PSEUDOEPHEDRINE SULFATE, ADHESIVE TAPE, SAGE, MOLD, JUNIPER TREES, RABBITS, HAMSTERS, GUINEA PIGS","['Erythema', 'Injection site reaction', 'Local reaction', 'Mass', 'Pain', 'Pruritus', 'Swelling']",1,MODERNA,IM 927100,,47.0,F,About 10 minutes after Covid vaccination was given patient experienced itching up and down left arm (which was the arm the injection was given in). Patient describes itching as mild. Vitals 1820: BP:129/94 P:83 SaO2: 99% Itching still present but has not worsened or moved to more areas of body. Vitals 1830: BP: 132/88 P: 85 SaO2: 99 Patient states itching has lessened somewhat. Patient denies the need for further care or medication. Patient was able to stand/walk without dizziness and had no other symptoms or complications. After her 30 minute wait time was complete patient left.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,['Pruritus'],1,PFIZER\BIONTECH,IM 927101,MA,32.0,M,"Received my vaccine on Wednesday 12/30/20. The following Tuesday 1/5/21, I woke up with uncomfortable swollen Axillary lymph nodes. Thursday evening (1/7/21) I noticed redness and slight swelling at the injection site. Swollen nodes continue.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/05/2021,6.0,PVT,Montelukast Sodium 10mg 1xDaily Olopatadine Hydrochloride Nasal Spray,,,,Occasional minor itching to pitted fruits,"['Discomfort', 'Injection site erythema', 'Injection site swelling', 'Lymphadenopathy']",1,MODERNA,IM 927102,FL,37.0,F,2 to 3 inch raised fevered circular whelp stated 7 days after injection. Took Zyrtec and Chlorphenamine and put a cold compress on site.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,PVT,"Adderall 20mg, Cymbalta 60 mg, Zyrtec 10mg, Chlorphenamine 4mg, Prilosec 40mg, Singulair 10mg, Epi-Pen prn",Nothing,Migraines and PCOS,,Peanuts causes anaphylaxis and Verapamil causes hives,"['Injection site reaction', 'Injection site warmth', 'Urticaria']",UNK,MODERNA,IM 927103,WA,41.0,F,"Vomiting, diaphoresis",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,,,Diabetes Psoriasis RA,,metformin nuts,"['Hyperhidrosis', 'Vomiting']",2,PFIZER\BIONTECH,IM 927104,UT,35.0,F,"Severe headache, muscle weakness, tingling sensation on left side, dizzy, feeling itchy but no rash, red and hot cheeks come and go, from day 1 until Day 8. Today new swelling, itchy, redness and hard lump at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PUB,Sertraline 100mg,,,,Sulfa Penicillin,"['Dizziness', 'Erythema', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site mass', 'Injection site pruritus', 'Injection site swelling', 'Muscular weakness', 'Paraesthesia', 'Pruritus', 'Skin warm']",1,MODERNA,IM 927105,CA,59.0,F,Fever that went away with tylenol.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,,,,['Pyrexia'],2,PFIZER\BIONTECH,IM 927106,TN,40.0,F,"9:02am rec'd vaccine approx 9:10am - severe itching that started on the left side and crossed over to the right side and included small hives on my chest 9:38am, I took 2 - 25 mg benadryl tablets advised by the nurse at the testing center approx 10am, the itching was worsening and was advised to take another 25mg benadryl approx 10:10am was feeling relief and left the vaccine distribution site 10:45 am arrived home and and slept for the rest of the day experienced arm soreness for 4 days post vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,OTH,Synthroid celexa,none,seasonal allergies,,biaxin clendamician omnicef keflex cipro doxycycline,"['Pruritus', 'Urticaria']",1,MODERNA,IM 927107,MI,34.0,F,"Red, swollen, itchy injection site beginning 7 days after injection. Redness continued through day 9 after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,UNK,"Prenatal vitamins, birth control",None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 927108,NY,46.0,F,"12 hours after vaccine I felt chills, headache, fever, dizziness, weakness, pain and swelling to injection site, body aches, lymph node swelling. 36 hours after, still have piercing headache, fever, body aches, lymph node swelling, weakness, on and off chills and dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,,,"Diabetes, asthma, divertculosis, linear morphea, hypothyroidism, anemia, fatty liver",,,"['Asthenia', 'Chills', 'Dizziness', 'Headache', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 927110,CA,44.0,F,"Approximately 10 minutes after vaccination developed increased heart rate, dizziness, and shakiness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Welbutrin xL 450 mg one daily,None,none,,none,"['Dizziness', 'Heart rate increased', 'Tremor']",UNK,PFIZER\BIONTECH, 927111,IL,30.0,M,"The vaccination was administered on Saturday evening, December 19th, 2020. The next morning around 10 am I began to feel nauseous and light-headed. That feeling waxed and waned all day and improved in the evening. The next morning on Monday, December 21st I was 10/10 nauseous and near vomiting. I went to work but had to leave because of nausea. Ultimately I vomited upon returning home and was nauseous with abdominal pain and achy all day. The next morning on Tuesday, December 22 nausea continued but with a rating of around 6/10. Then came the intense headache, body aches, and fatigue. This continued into the next day (Wednesday, December 23) prompting me to get COVID tested and take off of work on Thursday, December 24th. Nausea improved (5/10) on December 24th but fatigue, abdominal pain, and body aches did not. December 25-27 were slow improvements with nausea, abdominal pain, and fatigue but were limiting activities of daily living. By Monday, December 28th most symptoms had cleared.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/20/2020,1.0,PVT,nasonex,none,none,,"penicillin, celcor, sulfa, bactrim","['Abdominal pain', 'Dizziness', 'Fatigue', 'Headache', 'Impaired work ability', 'Loss of personal independence in daily activities', 'Nausea', 'Pain', 'SARS-CoV-2 test', 'Vomiting']",1,PFIZER\BIONTECH,IM 927112,GA,49.0,F,"@12:45pm Pt c/o slight dizziness w/nausea, blurred vision after 5 minutes and diaphoretic, obtained v/s (stable) assisted laying down on stretcher. Bottle water offered and took several sips. � @12:54pm Dr arrived for provisder Assessment and noted stable just continue monitoring. Waiting for longer observation for 20 more minutes. Pt states,""I feel a lot better."" � Pt taking Ceftriaxone currently and finished prednisone x2 days after a course of several days. � Pt advise to call if s/sx return or get worse. � Allergies updated and Covid-19 vaccine added, suggested ""not recommended for 2nd dose"" and 2nd dose appt canceled.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Medications Outpatient Medications at End of Encounter on as of 1/7/2021 Disp Refills Start End Montelukast (SINGULAIR) 10 mg Oral Tab 90 1/1 3/16/2020 3/15/2024 Sig - Route: TAKE 1 TAB PO QHS - Oral Class: Historical Med Levothyroxine (,Problem List Date Reviewed: 3/16/2020 as of 1/7/2021 ICD-10-CM Priority Class Noted - Resolved INTERMITTENT ASTHMA (Chronic) J45.20 3/16/2020 - Present ACQUIRED HYPOTHYROIDISM (Chronic) E03.9 3/16/2020 - Present,,,"Allergies Allergies as of 1/7/2021 Severity Noted Reaction Type Reactions Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-s (pfizer) Not Specified 01/07/2021 � Allergy Nausea and/or Vomiting, Other Diaphoretic, nausea, lightheadedness, dizziness and blurred vision 5 minutes afterwards","['Dizziness', 'Hyperhidrosis', 'Nausea', 'Vision blurred']",1,PFIZER\BIONTECH,IM 927113,CA,57.0,F,"at 4:08 pm, 10 minutes after receiving vaccine pt reports feeling dizzy and has bilateral rash on arms. pt was evaluated by EMS. BP 124/80, P 82, O2 Sat 100%. pt reports feeling better and declined EMS transport to hospital and left AMA 4:26",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,,,,,,"['Dizziness', 'Rash']",1,PFIZER\BIONTECH,IM 927114,OR,20.0,F,"01/06/2021 Patient complains of sore throat onset 2030 01/07/2021 Patient continues to have sore throat, temperature 100.1 at 1300 with headache and body aches. Pt also found out she had direct exposure to COVID on 01/04/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Body temperature increased', 'Headache', 'Oropharyngeal pain', 'Pain', 'SARS-CoV-2 test negative']",1,MODERNA,IM 927116,WI,59.0,F,"Patient reported headache-like symptoms with pressure, tightness and extreme fatigue. Patient also reported worsening tinnitus which started 12/22/2020, prior to the vaccine administration date.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/30/2020,2.0,WRK,"cetirizine, famotidine, GAVISCON EXTRA RELIEF FORMULA PO, albuterol inhaler HFA as needed, flonase nasal spray","asthma, GERD, allergic rhinitis to mold",none,,"environmental allergies to mold, latex, hydrocodone","['Condition aggravated', 'Fatigue', 'Head discomfort', 'Headache', 'Tension headache', 'Tinnitus']",1,PFIZER\BIONTECH,IM 927117,,63.0,F,"Patient describes a red, itchy rash at the injection site in a 3"" diameter. She also reports nausea and a headache for 2 days. The rash was warm to the touch",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/27/2020,1.0,WRK,,,,,,"['Headache', 'Injection site reaction', 'Injection site warmth', 'Nausea', 'Rash erythematous', 'Rash pruritic']",UNK,MODERNA, 927118,ID,36.0,M,Hives on torso and upper extremities,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,None,None,None,Same reaction with first covid vaccine.,None,['Urticaria'],2,PFIZER\BIONTECH,IM 927119,CA,45.0,F,"When patient initially received the vaccination, she complained of mild dizziness. She went home after monitoring and returned to work the PM shift rested. Approximately 45 minutes into the shift, she c/o dizziness. She had elevated BP 209/102 and HR 108 and at one point had a syncopal episode. Emergency services was called and she was transferred to the hospital for further evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,SEN,HTN medication,Unknown,Unknown,,Unknown,"['Blood pressure increased', 'Dizziness', 'Heart rate increased', 'Syncope']",1,PFIZER\BIONTECH,IM 927120,AS,48.0,F,"Itching on arm in area of injection site, reports feeling weird, eyes are reddened and itchy. Patient reports feeling short of breath but no noted drop in oxygen saturation. Oral diphenhydramine 50mg administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,None reported by patient,None on record,None on record,,Augmentin--unknown reaction type,"['Dyspnoea', 'Eye pruritus', 'Feeling abnormal', 'Injection site pruritus', 'Ocular hyperaemia']",2,PFIZER\BIONTECH,IM 927121,NY,61.0,F,Pt stated that she was feeling a tickle in her throat 10 minutes after administration of the vaccine. Pt stated that her throat is dry and feels a sensation to cough. Pt stated that started feeling swelling of the tongue 30 minutes after administration of the vaccine. Pt was given water and says that it helped relieve itching. Pt was given benadryl 25mg IM and is being monitored. Charge nurse is taking over monitoring and care of patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,"levothyroxine - 75mg once daily losartan - 25mg once daily pantoprazole - 40mg once daily creon - 24,000 units with meals",pt denies,"pancreatitis (IGG4 related), hypothyroidism",,"latex: itchiness, blisters kiwi: itchiness in the throat, hard to swallow okra: hard to swallow, itchiness in the throat morphine: trouble breathing penicillin: lightheadedness, itchy","['Cough', 'Dry throat', 'Pruritus', 'Swollen tongue', 'Throat irritation']",1,PFIZER\BIONTECH,IM 927122,PA,49.0,F,Patient reported weakness and pain in neck and back,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,unknown,unknown,unknown,,unknown,"['Asthenia', 'Back pain', 'Neck pain']",1,PFIZER\BIONTECH,IM 927124,NM,46.0,F,Patient received IMZ on 12/30/20. One 1/7/21 at approximately 2:00pm she developed 2 raised areas on her arm with a valley between. There was also pain in the arm at that area.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PHM,Patient took a Tylenol 8 days after vaccination,none,none,,none,"['Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 927125,GA,50.0,F,"patient had Covid 19 vaccine from Pfizer with lot #EJ1686 with expiration date 3/2021 on 1/7/2021 and after 45 minutes, she came back and stated she has chest tightness, lip swelling, chest congestion, shortness of breath, asthma-like symptoms with mucus type in her chest. her BP at that time was 184/109. She was given 1 EpiPen and 2 Benadryl 25mg tablets.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,not available,"no, her temp. taken at the time vaccinated 96.3",not available,,Cephalosporins and Penicilline,"['Asthma', 'Blood pressure increased', 'Chest discomfort', 'Dyspnoea', 'Lip swelling', 'Respiratory tract congestion']",1,PFIZER\BIONTECH,IM 927126,WV,39.0,F,Fever High heart rate Chills,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Chills', 'Heart rate increased', 'Pyrexia']",1,PFIZER\BIONTECH,IM 927127,WA,33.0,F,Felt my arm was about to fall it was sever pain I couldn't touch it or do anything with it I also had lower back ache.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,PVT,prenatal vitamins,No,No,,No,"['Back pain', 'Pain in extremity', 'Tenderness']",UNK,MODERNA,SYR 927128,PA,32.0,F,"Tingling in left arm about 30 minutes after administration, followed by numbnes in the pinky and ring fingers for approximately 12 hours. Moderate left arm pain for approximately 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Cymbalta 35mg daily, imitrex 100mg as needed",None,Migraines,,None,"['Hypoaesthesia', 'Pain in extremity', 'Paraesthesia']",1,MODERNA,IM 927129,OH,49.0,F,"About an hour after the injection I had pain and burning going down my left side and in the left side of my chest that lasted about 45 min. I was fine for the next 12 hr. Around midnight I started with chills, joint pain body aches and a headache. I woke up around 2 am with a fever. All day on the 6th I felt horrible with body aches, joint pain and a severe headache. Around 10 pm on the 6th I started again with chills fever chest pain SOB Cough and vomiting (3 episodes throughout the night.) My lungs currently feel like they are on fire and I continue to have chest tightness, joint pain Severe headache and a cough. I am approximately 56 hr post second vaccination. I had no problems with the first vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,UNK,None,None,None,,None,"['Arthralgia', 'Chest discomfort', 'Chest pain', 'Chills', 'Cough', 'Dyspnoea', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 927132,CA,31.0,F,Unrelated to vaccine. Related to method of injection. Pt stated she felt ?like a nerve in my arm had been hit?. Medics assessed her further and she AMA?d from their care.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,Unknown,Unknown,Unknown,,Unknown,"['Injection related reaction', 'Neuralgia']",UNK,MODERNA,IM 927133,MN,55.0,F,fever feeling of unwell fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"CS-Progeterone 80 Taurine. 1,000 mg- Black Cohosh- 300 mg Magnesium 400mg",Per-menopause symptoms,none,,steri strips Bioxin,"['Fatigue', 'Malaise', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 927134,VA,30.0,M,"fever, soreness in arms and legs, headache, fatigue, began last night around midnight (january 7)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,,,,"30 years old, flu shot on 10/3/20",,"['Fatigue', 'Headache', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 927135,CA,51.0,F,"Patient had her first dose of Pfizer covid 19 vaccine. She was observed for 30 minutes, 15 minutes longer than normal as a precaution, due to her allergies. Patient continued to moniter her oxygenation saturation and did not report a drop in oxygen saturation, however, she reported a funny feeling in her throat, difficulty swallowing and shortness of breath. She was escorted to the emergency department via wheelchair for further observation and treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,"vBariatric Vitamin Regimen: Multivitamin with iron, B12, B1, Vitamin D and calcium citrate plus D chews (sometimes) Doc-senna 2 tabs BID, docsenana 2 tabs daily, Bisacodyl 5 mg PO Bisacodyl 5mg at bedtime miralax 1x a day ergocalciferol 12",,"GERD (GASTROESOPHAGEAL REFLUX DISEASE) SEVERE OBESITY (BMI >= 40) HX OF BARIATRIC SURGERY HX OF GASTRIC BYPASS SURGERY CHRONIC PAIN ADRENAL INSUFFICIENCY, UNSPECIFIED ASTHMA, UNSPECIFIED HYPOTHYROIDISM ANXIETY MAJOR DEPRESSION, RECURRENT SUPRAVENTRICULAR TACHYCARDIA, PAROXYSMAL FIBROMYALGIA PITUITARY CYST ATRIAL FIBRILLATION, PAROXYSMAL COMPLEX MIGRAINE HEMIPLEGIA, LEFT NONDOMINANT SIDE HEMIPLEGIC MIGRAINE CHOLEDOCHOLITHIASIS CORONAVIRUS COVID-19 RULED OUT GASTROPARESIS SINUS BRADYCARDIA POLYCYSTIC OVARIES HX OF GESTATIONAL DM ATOPIC DERMATITIS ERYTHEMA NODOSUM HX OF DM RESOLVED POST BARIATRIC SURGERY AFTERCARE FOR BARIATRIC SURGERY ABNL ABDOMINAL IMAGING OPIOID MEDICATION AGREEMENT LETTER RENAL CALCULUS IRON DEFICIENCY WO ANEMIA FEEDING OR EATING DISORDER, OTHER SPECIFIED MONITORING OPIOID THERAPY SCREENING FOR DEPRESSION CASE / CARE MGMT, CHRONIC PAIN MGMT SOAPP SCORE LESS THAN 4, SCREENER OPIOID ASSESSMENT PATIENTS W PAIN 5 QUESTIONS GENETIC COUNSELING HYPERMOBILITY SYNDROME DIABETES MELLITUS RULED OUT AFTER EVALUATION OVERUSE DISORDER OF SOFT TISSUES, RIGHT SHOULDER OVERUSE DISORDER OF SOFT TISSUES, RIGHT FOREARM RIGHT MEDIAL EPICONDYLITIS CHRONIC PAIN COUNSELING ADMINISTRATIVE ENCOUNTER FOR LEVEL III PAIN GROUP SERIES URETERAL CALCULUS CERVICAL SPONDYLOSIS ARTHRITIS OF LEFT HIP",,"Nsaids, Non-selective [non-steroidal Anti-inflammatory Agents] High GI Bleeding Higher risk GI Bleed �in sleeve gastrectomy. If absolutely necessary please cover with a proton pump inhibitor. Adhesive Tape Not Specified Plastic tape causes skin irritation Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-s (pfizer) Not Specified Cough Fever, cough, wheezing Epinephrine Not Specified Patient states allergic to EPI Erythromycin Base Not Specified 1999-03-16;ANAPHYLAXIS Morphine Sulfate Not Specified Hallucinations pruritis Prochlorperazine Not Specified Other. 2000-09-12;dystonic rxn Reglan [metoclopramide] Not Specified Dystonic Reaction Had dystonia at high dose 40 mg/day.able to tolerate 20 mg/day Seroquel [quetiapine Fumarate] Not Specified dystonia Valium [diazepam] Not Specified","['Cough', 'Dysphagia', 'Dyspnoea', 'Oropharyngeal discomfort', 'Pyrexia', 'Wheezing']",1,PFIZER\BIONTECH,IM 927136,PA,39.0,F,Nausea and vomiting within 30-45 minutes Fatigue and sore muscles the following day,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Labetolol Nifedipine,,Hypertension,,Penicillin,"['Fatigue', 'Myalgia', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,SYR 927137,NJ,48.0,F,"Within 2 - 3 minutes of receiving the vaccine in my left deltoid muscle, the upper half of my left middle finger felt numb, had tingling and felt very cold. There was significant color change: it turned white and my pulse oxygen level could not be measured in that finger. It took approximately 25-30 minutes to go back to normal. I?ve never had any type of reaction to a vaccine or injectable medication in the past. No treatment was necessary and no additional symptoms have been noted this evening / 6 hours later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Emgality, Multivitamin, Vitamin D3",None,Migraine headaches,,None,"['Feeling cold', 'Hypoaesthesia', 'Paraesthesia', 'Skin discolouration']",1,MODERNA,SYR 927138,TX,40.0,F,Moderna COVID-19 Vaccine EUA Pain in arm for 24 hours Have redness at injection site Itch at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,WRK,Synthroid 88mcg Cranberry supplement Vitamin D supplement,None,Hypothyroid,,Sulfa,"['Injection site erythema', 'Injection site pruritus', 'Pain in extremity']",1,MODERNA,IM 927139,RI,48.0,F,"1633 - patient c/o dizziness and tingling to lips. 1641 - BP 167/63, pulse 80, anxious, Benadryl 25 mg PO administered. Requested water, 2 bottles given. 1643 - BP - 142/91, pulse 75. RN continue to monitor. 1700 - States feels much better. No further complaints voiced, continue to closely monitor. 1707 - Discharged to home in stable condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Anxiety', 'Dizziness', 'Paraesthesia oral']",1,MODERNA,IM 927141,GA,50.0,F,"PATIENT COMPLAINED OF LIGHTHEADEDNESS, VOMITING X2, GAGGING, DROWSY, UNSTABLE, TACHYCARDIC HR 110, BP 142/91",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,,,NONE,,NKDA,"['Balance disorder', 'Dizziness', 'Retching', 'Somnolence', 'Tachycardia', 'Vomiting']",1,PFIZER\BIONTECH,IM 927142,PA,57.0,F,Patient reported pain and weakness,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,SEN,unknown,unknown,none,,"penicillin, codeine","['Asthenia', 'Pain']",1,PFIZER\BIONTECH,IM 927143,TX,34.0,F,"Day 1 (1-5-21): sore arm bruise Day 2 (1-6-21): more severe sore arm and bruise Day 3 (1-7-21): sore arm that's getting better. Red, inflamed, hot to touch at injection site. 1in x 2in in size.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,PVT,Ibuprofen and benefiber,None,None,,Shrimp,"['Contusion', 'Injection site erythema', 'Injection site inflammation', 'Injection site warmth', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 927144,CA,53.0,F,"lump (undulation), itchy, red at vaccine site - 2 days later it is less of a lump, not itchy or red - no other symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,01/05/2021,9.0,WRK,Lisinopril-Hydrochlorothiazide 20-25 mg per tablet,,high blood pressure,,,"['Injection site erythema', 'Injection site mass', 'Injection site pruritus']",1,MODERNA, 927145,CT,38.0,F,LOCALIZED WELL DEMARCATED REACTION DEVELOPED 8 DAYS AFTER VACCINATION AT SITE ON LEFT ARM. PRURITIC INITIALLY BUT NOW DISCOMFORT WITH LOCALIZED ADENOPATHY AND FATIGUE,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,HCTZ 25MG QD LISINOPRIL 5MG QD,NONE,HYPERTENSION,,NKDA,"['Fatigue', 'Local reaction', 'Vaccination site discomfort', 'Vaccination site lymphadenopathy', 'Vaccination site pruritus']",1,MODERNA,IM 927146,CT,72.0,M,I awoke at 3 AM with shaking chill and muscle aches of moderate intensity (5 on a scale of 1 to 10). I took 400 mg of ibuprofen and symptoms subsided substantially in 30 minutes. Much milder symptoms persisted for 24 more hours and then almost completely resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Lisinopril 5 mg daily Vitamin D 2000 IU daily Rosuvastatin 5 mg twice weekly,None,Borderline elevated hypertension,,Penicillin ---Rash Sulfa drugs---Rash,"['Chills', 'Myalgia', 'Tremor']",2,PFIZER\BIONTECH,IM 927147,MI,63.0,F,I had a positive Covid 11/11/20. My main symptom was loose stools x 3 weeks,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PUB,I do not have my list,Positive for covid 11/11/20 Chronic sinusitis,Mild copd,,,['Diarrhoea'],1,PFIZER\BIONTECH,IM 927148,OR,36.0,F,"Within 5 minutes after Moderna dose 1 vaccine patient developed tingling around the lips and tongue. Patient has a history of anaphylaxis to Latex, and ceftriaxone. HR 86 and regular, BP 130/80, O2 96% on room air with mask on. After further evaluation patient c/o feeling winded like "" I just finished a walk pushing the stroller."" Lungs and throat sound clear. Discussed with patient the pros and cons of administering benadryl and or epi and that would require a visit to the ED for further evaluation. Patient concerned about how the drugs will affect her breast feeding. Through our conversation, the tingling of the lips and tongue has increased, patient is stable, decision made to wheel patient to the ED for evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,unknown,unknown,unknown,,"Ceftriazone - anaphylaxis Latex- Anaphylaxis, Hives, Rash","['Breast feeding', 'Dyspnoea', 'Paraesthesia oral']",UNK,MODERNA,IM 927149,PA,64.0,F,"Localized reaction, hot, hard, raised, reddened area (approximately 2"" in diameter) at injection site. Slightly painful and itchy. Did not occur until 8 days post injection. No treatment required.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,PVT,"Losartin, ozempic, metformin , metoprolol, Baby ASA, probiotic, atorvastatin, mega red krill oil",none,"controlled hypertension , DM II",,none known,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 927150,NM,40.0,F,"Bilateral muscle cramps/ spasm quadriceps. Deep, severe left hip pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PHM,"Birth control, bupropion, vit D, biotin",,,,Sulfa,"['Arthralgia', 'Muscle spasms']",1,MODERNA,SYR 927151,MN,49.0,F,Metallic taste in mouth started about 5 minutes after injection. lasted approximately for 1 hour,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,none,none,none,,none,['Dysgeusia'],1,PFIZER\BIONTECH,IM 927153,,61.0,F,"Patient describes headache and dizziness, also fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Dizziness', 'Fatigue', 'Headache']",UNK,PFIZER\BIONTECH, 927154,CA,27.0,M,Tingling in arm and head fogginess approx 10 min post vaccination. Assessed by paramedics and refused transport AMA.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,Salcylate,Denies anything else,Back Pain,,Morphine,"['Feeling abnormal', 'Paraesthesia']",UNK,MODERNA,IM 927155,HI,34.0,F,"Patient reported an ""itchy throat"" described as a ""mild reaction"". Remained under observation for additional time, no intervention or additional treatment provided.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,,,,,,['Throat irritation'],1,PFIZER\BIONTECH,IM 927156,MA,26.0,F,"Nausea, chills, low grade fever, headache, lethargy, right arm soreness. I woke up around 5am and noticed these symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"Cholecalciferol, spironolactone",Began menstrual cycle on day of vaccine (I have a history of fever/nausea/vomiting at the beginning of my cycle. It only happens maybe one or two times a year).,,,No,"['Chills', 'Headache', 'Lethargy', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 927158,NC,76.0,F,Developed a severe headache within 2-3 hours of receiving vaccine. Took 2 Tylenol. Headache abated but did not resolve. Within the next 2-3 hours felt tingling in my left upper lip. It grew worse and headache worsened. Lip felt like it was swelling but no change was seen. Then left side of face began to ache. Took 2 more Tylenol. Texted my primary care physician who recommended Benadryl in case it was an allergic reaction. Took Benadryl about 4:30 or 5:00. Left work and went home. Had severe headache. Took my blood pressure. It was 185/68. Had some old Propanolol 10 mg from 2 years earlier and took one and a Prednisone 10mg. By 9:00 pm still felt bad with facial pain and tingling. BP decreased to 148/89. Took another Benadryl and went to bed. Face ant lip better in the morning. Arm sore for 2 days. Developed body and joint aches for the past 2-3 days. Slowly resolving.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,Synthroid,None,Graves Disease/Hypothyroidism,,None,"['Arthralgia', 'Blood pressure increased', 'Facial pain', 'Feeling abnormal', 'Headache', 'Lip swelling', 'Pain', 'Pain in extremity', 'Paraesthesia oral']",1,MODERNA,IM 927159,PA,56.0,F,Patient reported fever and body aches for 8 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,SEN,unknown,unknown,unknown,,unknown,"['Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 927161,VA,33.0,F,localized reaction red bump. hot to touch. not painful,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,PVT,phentermine,no,no,,no,"['Erythema', 'Local reaction', 'Skin warm', 'Swelling']",1,MODERNA,SYR 927162,TX,54.0,M,Patient developed dyspnea on exertion noted 7 days after his vaccine; Note that he had fully recovered from COVID infection one month prior with cardio on bicycle without drop off of performance metrics. DOE was noticeable on bike rides - almost had a syncopal episode on a bike hill climb at post injection day 10; medrol dose pack started - symptoms resolved in one week. No sign of desaturation noted on pulse oximetry; patient elected NOT to pursue the second vaccination shot given the side effects.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/15/2020,12/22/2020,7.0,PVT,Enbrel Zyrtec Tamsulosin Fish Oil Vit C. Naprosyn,Post- mild COVID course 1 month prior to vaccine (Pfizer vaccine),Psoriatic arthritis Eosinophilia esophagitis GERD Seasonal allergies,,Cephalosporins-- > rash (PCN OK) No food allergies,"['Computerised tomogram normal', 'Dyspnoea', 'Presyncope', 'Pulmonary function test normal']",1,PFIZER\BIONTECH,IM 927163,HI,34.0,F,Patient reported tingling and numbness to one side of face and spreading down her neck. Patient transferred to E.D. for observation.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,,,,No history of allergic reaction.,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 927164,WA,57.0,F,"ON 12/31/2020 I HAVE A HAD SLIGHT FEVER, HEADACHE , NAUSEA, BODY ACHES, CHILLS, HAND TREMORS, DIZZY AND LIGHTHEADED THAT LASTED FOR 3 DAYS. SINCE THEN I HAVE A BAD HEADACHE, FEELING NAUSEA AND VERY LIGHT HEADED AT TIMES.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Levothyroxine, Llothyronine and Sertraline",none,Hypothyroidism,"PNEUMONIA VACCINE ARM VERY PAINFUL AND SWOLLEN, COULD NOT MOVE IT FOR TWO DAYS",NKA,"['Chills', 'Dizziness', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Tremor']",UNK,PFIZER\BIONTECH, 927165,WA,44.0,M,"33 hours post vaccination: experienced heartburn, discomfort followed by urticaria on my neck, trunk, armpit, and back. Took diphenhydramine. Woke up with no itching by some swelling of left eyelid. At 1500 1/7/21, some outbreak of urticaria on my back, underarm, neck, trunk area, and groin area. Took lower dose of diphenhydramine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,none,torn leg muscle (abductus magnus) 12/5/20,none,,none,"['Discomfort', 'Dyspepsia', 'Swelling of eyelid', 'Urticaria']",1,MODERNA,IM 927166,AZ,27.0,F,"Beginning January 2nd, 11 days after my covid vaccine I developed right sided back pain. Two days later I had an area of papules on my anterior thigh the size of a half dollar. The right sided back pain then began to radiate around to my hip and the rash began to be painful. My right thigh eventually began to tingle and and the pain increased in severity. On Jan 7th I presented to the acute care clinic at the Clinic and was diagnosed with shingles.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/02/2021,11.0,PVT,Drospirenone birth control pill,None,None,,None,"['Arthralgia', 'Back pain', 'Herpes zoster', 'Pain', 'Papule', 'Paraesthesia', 'Rash']",1,PFIZER\BIONTECH,IM 927167,MA,16.0,F,"Entered observation @ 1935. Mother stated to this nurse @ 1950, that daughter felt ""light-headed"". Water was given. @ 1954, patient started to gag. Went to restroom. @ 1958, she was walked with this nurse and others to ""bed"" that's located in vaccination clinic. Mother explained to this nurse and others that her daughter shows s/s of these symptoms upon each vaccination. Lightheadedness and nausea lasted for about 10-15 minutes. Cold compress was applied to help relieve s/s from vaccine. States she felt better around 2005. Left observation @ 2005, showed no s/s of distress.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,,,,States that she usually has same reactions to any vaccine she takes,,"['Cooling therapy', 'Dizziness', 'Nausea', 'Retching']",1,PFIZER\BIONTECH,IM 927168,OH,46.0,M,"About 24 hours after injection I developed severe side effects as a result. The side effects included; Fever (up to 103.0), body chills, SEVERE vertigo, weakness, back pain, abdominal pain (cramping), diarrhea and joint pain. The side effects took about 3 days to relieve with abdominal cramping and diarrhea lasting for about 1 week.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PUB,,,,,,"['Abdominal pain', 'Arthralgia', 'Asthenia', 'Back pain', 'Chills', 'Diarrhoea', 'Pyrexia', 'Vertigo']",1,MODERNA,IM 927169,UT,44.0,F,"Counting day of vaccination as Day 1. Only mild soreness. Day 2-small red welt on left deltoid surrounding injection site. This continued to grow, red rash expanding from injection site. Sore, itching. By day 5 had gone with only bruising, but still itchy. Yesterday was Day 8. Noticed soreness and red welt was back around injection site. Today day 9 redness continued to grow-itchy and sore. Called ask HR and they recommended calling medical provider. Diagnosed with cellulitis and given 7 day course of antibiotics, claritin to help with itching. Instructions to let vaccination site know. Will complete antibotics 01/15/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/06/2021,8.0,WRK,,,,,,"['Cellulitis', 'Injection site bruising', 'Injection site erythema', 'Injection site pain', 'Injection site rash', 'Pain', 'Rash', 'Rash erythematous', 'Rash pruritic', 'Urticaria']",1,MODERNA,IM 927170,OH,37.0,M,"A few minutes post-vaccination, the patient developed a splitting headache that radiated from the neck up over the head. He had pain down his arm and leg on the opposite side (as well as itching-arm only)the vaccine was administered in. Nausea developed and became worse as time passed. No injection site reaction or trouble breathing reported. Once patient reported that his muscles hurt and he hurt everywhere EMS was called. The patient was transported to Hospital and discharged prior to the end of the clinic with Tylenol and Tums.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,SEN,,,,,Splitting headache with TB test,"['Headache', 'Injection site pruritus', 'Myalgia', 'Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 927171,PA,54.0,F,"Patient reported feeling, tired achy fatigued and a fever of 100 degrees",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,unknown,unknown,unknown,,unknown,"['Fatigue', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 927172,AZ,61.0,F,cobid vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,UNK,l-thyroxine 50mcg Pravastatin tab 20mg Lisinopril tab 5mg,none,none,,none,['Unevaluable event'],2,PFIZER\BIONTECH,SYR 927173,CA,41.0,F,"14 minutes post vaccination the individual complained of dizziness and itching in her throat. Vitals signs were obtained, including oxygen saturation, the individual was assessed my a medical provider and orders were given to administer 50 mg of Diphenhydramine IM. The individual was monitored for 30 additional minutes. After 30 minutes vitals were obtained, the individual denied any symptoms. Individual was instructed to follow up with primary care provider.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,None,,Autoimmune Condition,,Peanut,"['Dizziness', 'Throat irritation']",1,MODERNA,IM 927174,CA,35.0,F,"Three minutes after receiving the first dose of the Pfizer\BioNTech COVID19 vaccine today (time 11:34 am), this vaccine study participant developed swelling of both cheeks and ""was able to bite on both cheeks"" as well as vague flushing of the cheeks. She did not immediately report these symptoms but returned to the site of her injection (research study site) and reported the cheek swelling and facial flushing to our study nurse. She denied lip/tongue/airway swelling, difficulty breathing, nausea or vomiting, diarrhea, cough, wheezing, shortness of breath, rapid breathing, fever, headache, paresthesias, rapid heart rate, chest pain, or other symptoms at that time. I am a sub-I for Pfizer\BioNTech vaccine study and authorized an immediate dose of Benadryl 50 mg orally which she received. I examined her at 12:40 pm and she had a reassuring physical exam as follows: Constitutional: Appearance: Normal appearance; well-hydrated and alert; no retractions, tachypnea, nasal flaring, or audible wheezing/breath sounds. No pallor. HEENT: Head: Normocephalic and atraumatic. Nose: Nose normal without visible discharge. Mouth: Mucous membranes are moist. Cheeks: Minimal edema of both cheeks is present; no visible erythema on exam. Eyes: Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equally round and symmetric. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm, HR 80-90. Pulses: Normal pulses in left wrist 2+/2+; warm hands. Pulmonary: Effort: Pulmonary effort is normal; RR 12-14. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Neurological: Mental Status: She is alert; speech and comprehension are normal. The patient still felt unusual by 2:00 pm and was referred to our Emergency Room for further evaluation. In our ER, she had the following vital signs and exam findings: BP 140/87 | Pulse 73 | Temp 98.1 �F (36.7 �C) | Resp 16 | SpO2 100% Gen: well appearing, no apparent distress, speaking in full sentences, no dysphonia Head: normocephalic, atraumatic, no hematoma Eyes: pupils equal reactive to light, extraocular movements intact ENT: hearing grossly normal, oral mucosa moist without edema/angioedema Resp: speaking in full sentences, clear to auscultation bilaterally, no rubs/crackles/wheeze, normal effort Abd: normoactive bowel sounds, nontender nondistended, no rebound/guarding, no organomegaly, faint/resolving urticaria abd x2 Ext: no deformities, no joint swelling, no edema, faint patchy erythema bilateral upper arms Neuro: alert, nonfocal Psych: AAOX3, normal affect/mood � I walked to our emergency room and reexamined her, and the only new finding were some pink small nonraised popular lesions on her abdomen and proximal arms, but she had no urticaria. Her lungs remained CTA and she was otherwise as before. The emergency room only gave famotidine 20 mg to her and discharged her with an EpiPen to use at home (they specifically felt she did not need it in the ER), but gave her oral cetirizine 10 mg to take daily for the next few days. I asked her how she felt upon discharge from the ER and she felt fine/normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Escitalopram 20 mg daily, Wellbutrin 75 mg daily, Topamax 50 mg daily, Flonase daily as needed for allergic rhinitis symptoms, EpiPen 0.3 mg IM as needed for beesting.",No antecedent illness within past 30 days.,"Major depressive disorder, recurrent, in remission; migraine with aura; mild intermittent asthma; beesting allergy (without diagnosis of bee venom anaphylaxis); hypertension; cervical HPV LGSIL.",,History of beesting allergy without full anaphylaxis; allergist prescribed EpiPen for future beestings.,"['Flushing', 'Swelling face']",1,PFIZER\BIONTECH,IM 927175,TX,79.0,F,"A week after vaccine was administered I have redness, swelling and itching on vaccine site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2020,01/06/2021,343.0,PVT,"atenolol. losartan, citalopram buspirone",none,Chronic sinus problems and allergic rinithis,,hay fever and sulfa,"['Injection site erythema', 'Injection site pruritus', 'Vaccination site swelling']",UNK,MODERNA, 927176,NY,37.0,F,"Sore arm second day Right armpit and right front shoulder pain including clavicular area pain starting the fifth day Bump on right area started day 7 Day 8 large rash, itching near injection side Increase sweating from right armpit starting day 7",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/03/2021,4.0,PVT,"Pepcid, Folic acid, Tylenol",None,Subclinical hypothyroidism,,NKDA,"['Axillary pain', 'Hyperhidrosis', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Oedema peripheral', 'Pain in extremity']",1,MODERNA,IM 927177,TX,41.0,F,"12/29/2020-around 5:00 pm-sore throat and headache for couple of hours; minor blurry vision. Pain at injection site-hurt to raise arm to head 12/30/2020-little bit of nausea throughout day off and on-around 5:00 pm-fever (99.5), chills, headache, body aches, increased constant nausea. Moderate pain at injection site, redness 12/31/2020-fever (99.5-100.4), chills, nausea, headache, body aches until about 4:00 pm. Redness, swelling, moderate pain at injection site-(pain improved-able to move arm more than before), some minor itching off and on at injection site. 1/1/2021-Nausea, headache. Redness, swelling, pain at injection site-(Pain improved), injection site hard and hot to touch. Some minor itching off and on. Receive steroid shot from urgent care and took Benadryl 1/2/2021-Redness, swelling improved. Minor itching off and on. Took Benadryl. Had touch diarrhea. 1/3/2021-Swelling almost gone, redness almost gone. Minor itching off and on. Little nausea. Took Benadryl 1/4/2021-Swelling and redness gone. Minor itching once or twice-nausea briefly once. Took Benadryl 1/5/2021-Itching off and on-minor",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,Duloxetine-30 mg Montelukast-10 mg Atorvastatin-10 mg Metoprol-25 mg ER Pantoprazole-40 mg,Sinus Infection,Irritable Bowel Syndrome Generalized Anxiety Disorder Unspecified Tachycardia Chronic Fatigue GERD Hypercholesterolemia,,Reaction to scorpion sting-nausea,"['Chills', 'Diarrhoea', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vision blurred']",1,MODERNA,SYR 927178,,34.0,M,"On the day of vaccination my arm was sore but at night i had a fever, chills, muscle aches and headache associated with insomnia. Symptoms started to get worse the next day of vaccination as I was hardly moving my left arm and i had to get off work early because i couldn't stand on my feet for a long time. finally on the third day symptoms started to improve.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,,,,,,"['Chills', 'Dysstasia', 'Headache', 'Impaired work ability', 'Injected limb mobility decreased', 'Insomnia', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 927179,ND,30.0,F,"Moderna vaccine around 2 this afternoon Had initial reaction of flushing and tachycardia; nurse monitored her and symptoms went away about 15-20 minutes later. Around 5:15 pm this evening felt like ""a flip switched"" and suddenly felt flushing and itching, hives to chest, and became very lethargic. EpiPen given at 5:50 and all symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,none,none,sarcoidosis,,"PCN, Omnicef, Bees = anaphylaxis Vicodin=vomit Neosporin=Hives","['Flushing', 'Lethargy', 'Pruritus', 'Tachycardia', 'Urticaria']",1,MODERNA,IM 927180,OR,30.0,F,"Soreness for 1-2 after injection. Splotchy rash at injection site on day 3. Itching, hives, rash, and hot to the touch at the injection site and tender lymph nodes in the underarm area 7 days later.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,,,,,NSAIDs,"['Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site urticaria', 'Injection site warmth', 'Lymph node pain', 'Rash macular']",1,MODERNA,IM 927181,CA,43.0,F,"Soreness for 1-2 after injection. Splotchy rash at injection site on day 3. Itching, hives, rash, and hot to the touch at the injection site and tender lymph nodes in the underarm area 7 days later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,None,None,None,,Contrast Dye used in CT Scan,"['Dizziness', 'Dysphagia', 'Throat irritation']",1,MODERNA,IM 927182,MO,23.0,F,"Patient returned to clinic diaphoretic, nausea and vomiting per ED co-worker.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Hyperhidrosis', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 927183,AZ,61.0,F,cobid 19,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,pravastatin 20mg lisinopril 5mg L Thyroxine 50mcg,none,none,,none,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,SYR 927184,NJ,54.0,F,Approximately 45 minutes later on my drive home my face on the left side started to feel numb. It started on my cheek and gradually ran up to right under my left eye and down to under my chin. It lasted for about an hour then gradually started to disappear. I got a little nervous but checked all signs that I was not having a stroke.. I ate dinner and calmed down. I also took a Tylenol 500 mg and drank a lot of water It?s gone now. It?s now 8:29 pm. Just feeling tired now.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,Prozac Telmesarten htz,None,High blood pressure,,None,"['Fatigue', 'Hypoaesthesia', 'Nervousness']",1,MODERNA,IM 927185,AK,34.0,F,"Rash, to upper torso, itching on bilateral upper extremities.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,MIL,"Lunesta, Cyclobenzaprine",,"EEO, Eosinophilic Esophagitis, Lupus, Tertiary Lyme's, Anemia",,propranolol,"['Pruritus', 'Rash']",1,MODERNA,IM 927186,,26.0,F,12/23/20- mild arm soreness 12/24-12/25- (worse) very tender arm at injection site 12/24-12/25- extreme fatigue (literally no energy) 12/24- for a couple to several days- restless sleep/insomnia 12/24- (off an on for a few days) headache and runny nose All symptoms resolved within a week. Only took Tylenol or ibuprofen for headache/arm soreness. Massaged arm to help soreness and applied a cold compress.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,,,"Narcolepsy, sleep apnea, migraines, inappropriate sinus tachycardia",,,"['Cooling therapy', 'Fatigue', 'Headache', 'Injection site pain', 'Insomnia', 'Pain in extremity', 'Restlessness', 'Rhinorrhoea']",1,PFIZER\BIONTECH,IM 927187,MN,21.0,F,"Fatigue since an hour after injection, muscle pain since an hour after injection, site soreness sense 30 min after injection, chills for 45 minutes starting an hour after injection, and nausea for 45 minutes starting an hour after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,SCH,"Birth control, fluoxetine, spironolactone, b complex, citirizine",N/a,N/a,,"Tree and plant pollen, cats, ibuprofen","['Chills', 'Fatigue', 'Injection site pain', 'Myalgia', 'Nausea']",1,MODERNA,IM 927188,TX,47.0,F,"Fatigue, malaise, body aches, mild headache starting 12 hours after vaccination Fever of 101.3 24 hours after vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,WRK,Beyaz,none,None,,Sulfa,"['Headache', 'Malaise', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 927189,CA,74.0,M,Patient was vaccinated at 11am and was found at the facility in his room deceased at approximately 3:00pm. Nurse did not have cause of death,Yes,01/07/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,unknown,stroke,"hypertension, atrial fibrillation, atherosclerosis,",,none,['Death'],1,PFIZER\BIONTECH,SYR 927190,HI,45.0,F,"Allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms, started approximately 10 minutes after receiving vaccine. Reaction resolved with no treatment. Patient developed Bell?s Palsy 2-3 days after vaccine. Currently being treated with high dose steroids and acyclovir.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,Fluticasone propionate 50MCG/ACT nasal spray Epinepherine 0.3MG/0.3ML (EpiPen),None,Past medical hx of mitral valve prolapse,,Cephalosporins and nut (peanut-derived),"['Facial paralysis', 'Paraesthesia', 'Paraesthesia oral', 'Rash', 'Rash erythematous', 'Vaccination complication']",1,PFIZER\BIONTECH,SYR 927191,AR,59.0,M,"PT COMPLAINED OF HEADACHE, SHORTNESS OF BREATH, INCREASED HEART RATE AND CHEST PAIN. PT TOOK IBUPROFEN 400MG FOR HEADACHE. RESTED FOR ABOUT 30 MINUTES AND FELT BETTER. HAD A NURSE MONITOR HIM FOR ANOTHER 30 MINUTES.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PHM,,,,,,"['Chest pain', 'Dyspnoea', 'Headache', 'Heart rate increased']",1,MODERNA,IM 927195,,,M,"Patient reports an episode of dizziness about 2 hours after receiving the Moderna vaccine, lasting a little over an hour. He reports now that the symptoms seem to be overall improved, it is now 4.5 hours after the vaccine injection. Symptoms improved with rest, hydration, a snack and also took Sudafed as he thought it might be ear congestion initially.. Denies weakness, changes in his breathing, new swelling, confusion. Pt declined office visit appt. Agreed to go to ED/UC for new/worse/return of symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,,,,,,['Dizziness'],1,MODERNA,IM 927196,NY,31.0,F,Patient developed substernal chest pressure 5/10 Patient was given Benadryl 50 mg IM Immediately Continued observation Patient then developed nausea and continued chest pressure 5/10 Given Dexamethasone 4 mg IM at 10:30 Continued observation Patient then developed some eyelid edema and upper lip fullness Patient given Epinephrine 0.3 mg IM at 10:43 am NO trouble breathing NO tongue swelling No throat tightness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,none,none,PCOS Migraine,,an antibiotic - unclear which one,"['Chest discomfort', 'Electrocardiogram normal', 'Eyelid oedema', 'Full blood count normal', 'Lip swelling', 'Liver function test normal', 'Metabolic function test normal', 'Nausea']",1,MODERNA,IM 927197,PA,26.0,F,left arm soreness - pain radiating down arm to thumb & pain with movement (immediately after vaccination) unable to lift arm above chest height (4 hours after vaccination) mild burning sensation in upper left arm (4 hours after vaccination),Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,Desvenlafaxine Bupropion Buspirone,,"Depression, anxiety",,Azithromycin (Zithromax),"['Immediate post-injection reaction', 'Joint range of motion decreased', 'Pain', 'Pain in extremity', 'Skin burning sensation']",UNK,MODERNA,IM 927198,AR,48.0,F,"Very sore arm 1st day. 2nd day sore arm and lymph nodes under left arm where I got injection ,chills ,fever ( on Wed 6th pm) fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Verapamil 120 qam,240mg qpm Dexilant 60mg Estradiol 2mg Simvastatin 40mg Trazodone50mg Gabapentin 300mg qhs Benicar 40 mg Diclofenac 75 mg am m.w.f 75mg pm Metoprolol 50mg qhs Vit A ,D, C Zinc",Covid Dec 20th positive,,,None,"['Chills', 'Fatigue', 'Lymph node pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 927199,,22.0,F,CG received the Moderna vaccine on 12/23/2020 at 1700 had mild arm pain for two days then was fine. On 12/28/2020 noticed the pain was back and I now have a medium sized lump in my armpit that was causing pain. On 12/31/2020 began to have a rash around the injection site that was increasing in size and limiting arm mobility. PCH EH sent CG to WorkMed and CG was given Rx for Keflex which was completed on 01/07/2021--CG stated symptoms are greatly improve.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/28/2020,5.0,WRK,,,,,,"['Axillary pain', 'Injected limb mobility decreased', 'Injection site rash', 'Mass', 'Pain in extremity']",1,MODERNA,IM 927200,CA,42.0,F,"Patient reported swelling, redness, itching, hot to touch above her left breast. Patient took diphenhydramine",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,unknown,unknown,none,,none,"['Erythema', 'Pruritus', 'Skin warm', 'Swelling']",1,PFIZER\BIONTECH,SYR 927203,TX,37.0,M,"Patient complained of being lightheaded after immunization. Patient checked out by EMS, began feeling better shortly thereafter. Patient advised to call 911 or go to the nearest emergency room for any additional issues as needed. Also advised to sign up for v-safe. Patient left site stating he felt better.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PUB,,,,,,['Dizziness'],1,MODERNA,IM 927205,AK,46.0,F,"Fatigue, extreme headache, mild fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,None,None,None,,None,"['Fatigue', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 927206,GA,35.0,F,"12 hours post vaccination woke up and barely could lift right arm, chills, body aches, headache, fever 99.8, extreme fatigue for about 18 hours. Took 650 mg with 800 mg Motrin twice. Symptoms resolved after 18 hours. Fatigue lasted for over 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/27/2020,1.0,PVT,,Covid + on 11/27/20,No.,,NKA,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 927207,MN,45.0,F,"At approximately 8 hours post vaccine I began to have Sudden onset bilateral joint pain mostly in my elbows but knees and hips as well. Then my neck started really hurting. I got a headache. Nausea and powerful chills that made my whole body violently shake. My core temperature Dropped to below 96, high 95s. Over a period of two hours I have stabilized my body temperature, the shaking has stopped. However the headache and muscle aches persist. No respiratory symptoms have developed. I feel as if I am recovering, over a period of about four hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,Zoloft 100mg,Nome,Dermatomyocitis- in remission,,NkA,"['Arthralgia', 'Body temperature decreased', 'Chills', 'Headache', 'Myalgia', 'Nausea', 'Neck pain', 'Tremor']",2,PFIZER\BIONTECH,IM 927208,LA,61.0,F,"Fever 101.7 Chills, Body Aches, Generalized Weakness, Head Ache, Diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,UNK,"Synthroid, Atoravastatin,Metformin, B12 injections , multi Vit , Iron Supp",None,"Insulin Resistance, Pernicious Anemia",,Quinolone,"['Asthenia', 'Chills', 'Diarrhoea', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 927210,NJ,46.0,M,"1.) Redness, pain, and swelling of arm several inches *below* the needle-puncture site (starting within hours of injection) 2.) Transient tachycardia with heart rate to the 130s. Lasted a few minutes. Spontaneously resolved (occurred 31 hours after injection)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"Naproxen prn - for redness, swelling, and pain that oddly occurred several inches below the injection site.",none,none,,Reported rash to penicillin as infant (have had cephalosporins since),"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Tachycardia']",1,MODERNA,IM 927212,TX,54.0,F,"Immediate swelling of injection site; appeared to be flushed; stated she ""didn't feel right""; complained of some tightness in her throat; she is a pharmacist as well and we discussed NOT immediately administering an EPI PEN. She requested the liquid Benadryl option I suggested. I administered 25mg liquid Benadryl and within 5 minutes she was feeling better. I kept her for observation for 45 minutes and continued to monitor her all day. She felt ""dizziness/drowsiness"" which was attributed to the Benadryl. No further complaints of allergic like reaction after Benadryl was administerd.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PHM,Mobic 15mg qd; Protonix 40mg qd; Pristiq 100mg qd; Xyzal 5mg qd; Detrol La 4mg qd; Singulair 10mg qd,Allergies,HTN,,NKDA,"['Feeling abnormal', 'Flushing', 'Immediate post-injection reaction', 'Injection site swelling', 'Throat tightness']",1,MODERNA,IM 927213,NY,24.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Initally ater the vacine I experienced soreness and swelling at the site of injection. 7 hours after reciving my first dose of the vaccine I started experiencing numbness in my right arm/hand. No weakness, just numnbess & altered sensation in the right arm. Over the next 8 hours I felt the numbness spread to the entire right side of my body, down my leg, up my back, my abdomen, neck, and side of my face. In the morning I went to the emergnecy department to be evaluated per the reccomendation of employee heath and my PCP. The checked my labs and they were normal, I recived 1L NS bolus. I then followed up with my PCP after.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,"Claritin, Birth control, Flonase",None,Asthma,,None,"['Blood creatine phosphokinase normal', 'Full blood count normal', 'Hypoaesthesia', 'Injection site pain', 'Injection site swelling', 'Metabolic function test normal', 'Sensory loss']",1,PFIZER\BIONTECH,IM 927214,TX,43.0,F,"I received the vaccination at 0844 on Jan 4, by 1400 my arm was incredibly sore but I experienced no other symptoms until about 1600 when I began to feel a chill. By that time my arm hurt so bad I did not want to move it. When I woke up for work on Jan 5 I was exhausted and feverish. I took my temperature about 0600 and it was 101, by 0900 my temp had spiked to 103.8. Using fever reducers I was able to bring my temperature down later in the afternoon on Jan 5. By the time I woke up on Jan 6 I felt completely fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,MIL,Amitiza Wellbutrin,None,None,,None,"['Chills', 'Fatigue', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 927215,CA,52.0,F,Body aches Chills Fever of 101.3 F Joint pain Headache Dry cough,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/06/2021,2.0,UNK,,,,,,"['Arthralgia', 'Chills', 'Cough', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 927216,,30.0,F,"Day 1-2: sore arm Day 3: splotchy rash at injection site Day 7: rash larger than 2"" across, hives, itchiness, hot to the touch, and tender lymph nodes under the arm at/near the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,,,,,,"['Injection site pruritus', 'Injection site reaction', 'Injection site urticaria', 'Injection site warmth', 'Lymph node pain', 'Pain in extremity', 'Rash macular']",1,MODERNA,IM 927217,TX,66.0,F,"Patient complained of being lightheaded after immunization. Patient checked out by EMS, she began feeling better shortly thereafter. Patient advised to call 911 or go to the nearest emergency room for any additional issues as needed. Also advised to sign up for v-safe. Patient left site stating she felt better.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PUB,,,,,,['Dizziness'],1,MODERNA,IM 927218,AL,56.0,M,"Moderate COVID symptoms: body aches, fatigue, headache, brain fog",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,none,none,none,,none,"['Fatigue', 'Feeling abnormal', 'Headache', 'Pain']",UNK,MODERNA, 927219,RI,36.0,F,"Tachycardia, diaphoresis, headache, neck pain, muscle aches, fatigue. Everything but fatigue lasted approx 12 hours, fatigue about 4 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,melatonin,,obesity,,pollen allergies with significant oral allergy syndrome,"['Fatigue', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Neck pain', 'Tachycardia']",1,PFIZER\BIONTECH,IM 927221,MN,31.0,F,"Headache, significantly muscle/body aches, joint pain, significant fatigue. Continual, intermittent shooting abdominal pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,Prenatal vitamin and magnesium supplement,Sinus infection,POTS,,Seasonal allergies,"['Abdominal pain', 'Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Pain']",1,PFIZER\BIONTECH,SYR 927222,NV,52.0,F,"Received vaccine, went to observation area, sat down, 2 minutes later felt very flushed, hot, skin became red, and almost fainted. Similar to vasovagal experience without nausea at that time. Staff took me to nursing station, and I felt better within 10 minutes of laying down on ice pack, drinking water. Stayed there for an hour and got a ride home in case. Blood pressure was very elevated afterwards for several hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,"Armour thyroid, Zyrtec, spirolactalone",none,"interstitial cystitis, herniated disc S1-L5",,none,"['Blood pressure increased', 'Dizziness', 'Erythema', 'Feeling hot', 'Flushing']",UNK,MODERNA, 927223,TX,36.0,F,"Nausea, hives, anaphylactic shock, throat swelling, hypotension, headache, dizziness, weakness . The symptoms returned at 1:25pm the best day as well. I?ve now had two anaphylactic reactions",Not Reported,,Yes,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,Zoloft,None,None,,Latex,"['Anaphylactic shock', 'Asthenia', 'Blood test', 'Dizziness', 'Headache', 'Hypotension', 'Nausea', 'Pharyngeal swelling', 'Urticaria']",1,MODERNA,IM 927224,IN,39.0,F,"cellulitis suspected--hot red arm, doctor gave keflex has lasted 7 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PVT,unk,unk,unk,,unk,"['Erythema', 'Skin warm']",1,MODERNA,IM 927225,CA,46.0,F,"Within 30-45 minutes after injection, became ill with extreme dizziness, facial/neck swelling, skin pale, diaphoretic, c/o nausea with vomiting x1. Taken to ED. Treated with Benadryl 50mg IV, Zofran 4mg SL, meclizine 25mg PO, and 1 liter of 0.9% Normal Saline IV. Symptoms improved, discharged to home at 6pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,None,None,None,,None,"['Blood pressure orthostatic normal', 'Dizziness', 'Hyperhidrosis', 'Malaise', 'Nausea', 'Pallor', 'Swelling', 'Swelling face', 'Vomiting']",2,PFIZER\BIONTECH,IM 927226,AR,20.0,F,"Stayed fir Observation for 15 minutes then left. 25 minutes after injection, developed rash and swelling on arm, chest, face with rapid heart rate and shallow/rapid breathing. Called number on vaccine sheet and was sent to ER but was turned away due to over crowding (COVID) and told to go to PCP, which was two hours away. Went to urgent care instead and was immediately treated with steroids and antihistamine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Sprintec,None,"Irritable bowel syndrome, Severe reflex, Severe lactose intolerance",,"Hydrocodone, latex, severe lactose intolerance","['Heart rate increased', 'Hypopnoea', 'Rash', 'Respiratory rate increased']",1,PFIZER\BIONTECH,SYR 927227,MN,21.0,F,"Arm soreness at injection site, body aches, headaches. All occurred approximately 12:00pm the day after the injection and lasted 8 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,"Lexapro 20mg, Wellbutrin 100mg, Amitriptyline 10mg",,Chronic fatigue,,,"['Headache', 'Injection site pain', 'Pain']",1,PFIZER\BIONTECH,SYR 927229,CO,72.0,M,"On 12/6/2021 Resident reported via telephone to this nurse he was having NVD, fever(100.4), SOB, HA and hypoxia; this nurse to resident cottage, assessment confirms reported S/S, dispatched ambulance to transport to ED for treatment of COVID-19 S/S S/P positive COVID-19 test from nasal swap on 3 Jan 2021. Family, MD, other staff, DON notified; called in report to Hospital. The resident was treated in the ER and returned on 12/6/21 after about 6 hours at the hospital. Resident returned from ED for tx of Covid-19; resident in stable condition, treated with Prednisone and dexamethasone discharged back. New orders for Prednisone PO x 4 days. F/U with PCP or return if worsening symptoms. Resident reported on 1/7/2021 he is feeling good and has no s/s of COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,SEN,"CertaVite Senior/antioxidant tablet, Aspirin 81mg, Paroxetine 40mg, Primidone 50mg, Metoprolol Tartrate 25mg, Flomax 0.4mg, Finasteride 5mg, Spiriva Respimat 2.5mcg/act, Oscal 500/200 D-3 tablet, Lorazepam 1mg, Mucinex, Atorvastatin 20mg, C","The resident was reported to be positive for COVID-19 on 1/5/2021 from a sample collected during routine bi-weekly testing on 1/3/2021. The resident was asymptomatic for COVID-19 at time of testing and on 1/5/2021. The resident was placed in isolation for COVID-19 on 1/5/2021. Resident developed COVID sx on 1/6/2021. Treated for COPD exacerbation in early December exhibited by cough and SOB. The resident had been tested for COVID-19 numerous times in the past month with not detected results reported on 12/2, 12/6, 12/9, 12/13, 12/16, 12/20, 12/23, 12/27 and 12/31/2020.","Smoker 50+ years quit 2018. He uses supplemental oxygen at 2-3 LPM for treatment of COPD. He is currently being treated for hypertension, anxiety and depression.",,Latex,"['COVID-19', 'Diarrhoea', 'Dyspnoea', 'Headache', 'Hypoxia', 'Nausea', 'SARS-CoV-2 test positive', 'Vomiting']",1,MODERNA,IM 927230,CA,63.0,F,"Itching, throat tightness. Pt was evaluated by Provider, VS monitored, benadryl 25mg PO X1 dose. Pt full recover within 30min and monitored for another 30 min, discharged to home with husband who is a PA-C.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Vitamin B complex, Allegra, Ranitidine, Hydroxysine, Bupropion, Levothyroxine, Multi-Vitamin",,"Hyperlipidemia, Anxiety, Hypothyroid, Depressive disorder, obesity",,"Sulfa, Codeine, Ultram, Nubain, Tegretol","['Pruritus', 'Throat tightness']",1,MODERNA,IM 927231,TN,59.0,F,"Redness, swelling and itching",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PUB,Soolantra Atorvastin Iron B12 Diclofenac Magnesium Vitamin c Levothyroxine,None,Hypothyroidism,,None,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA,SYR 927232,PR,41.0,F,"Itching at the injection site, then the area became red, hot, swollen and tender. Treatment: cold press",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,OTH,Complex B Vitamin D Vitamin C EmergenC,None,None,,Aspirin Sulfa,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 927233,TX,24.0,F,"The following two days, I had a migraine. I also had swelling and tenderness at the vaccination site for 6 days afterwards.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Tri-Sprintec,None,Postural Orthostatic Tachycardia Syndrome,,None,"['Migraine', 'Vaccination site pain', 'Vaccination site swelling']",1,MODERNA,IM 927235,TX,31.0,F,"Pain, swelling, and soreness 1 day after the vaccine. Then pain, swelling, soreness, warmth, and redness 2 days after that has gotten worse. Itching started today, nine days after the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,None,None,None,,None,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Pruritus']",1,MODERNA,IM 927236,KY,35.0,F,"1. Noticing a sharp headache for about 10 seconds either in the occipital lobe region or temporal lobe region on the right side of my head every now and then. It has happened about 8 times since vaccine administration. The first time being about 25-30 minutes after vaccination. 2. I have also noticed a sharp pain in the back of my right thigh/upper buttock region that feels either like a nerve or muscle pain. It usually is most noticeable when I first stand up from a sitting position or laying position. If I don't put as much pressure on the heel of my right foot, it isn't as bad and ibuprofen has helped the pain subside, but it has been constant. This was first noticed about 4-5 hours after vaccination received.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Sertraline and generic Zyrtec, Juice Plus gummies","Not an illness, but I started my cycle/period that day. No illnesses known.",Crohn's Disease dx in 2005 and surgery in 2005 (right colectomy at the site of large and small intestine and appendix also taken out at that time). Glasses or contacts for vision.,,None known,"['Headache', 'Limb discomfort', 'Musculoskeletal pain', 'Myalgia', 'Neuralgia', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 927237,NY,25.0,F,"01/03/21 soreness in left armpit 01/04/21 to present swelling of lymph nodes and increased soreness, pain spreading to left breast and upper back 01/07/21 rash near left armpit",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/03/2021,7.0,PVT,Lo loestrin FE,,,,penicillin,"['Axillary pain', 'Back pain', 'Breast pain', 'Lymph node pain', 'Lymphadenopathy', 'Rash']",1,MODERNA,IM 927238,CA,30.0,F,body itchiness on right hand and left upper body. Soreness at the injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,none,,herpes,,none,"['Injection site pain', 'Pruritus']",1,PFIZER\BIONTECH,SYR 927239,KY,40.0,F,"At first, the injection site was a little swollen, red, itchy, warm to the touch, and painful. These symptoms weren't problematic at first and in fact, seemed to go away. Then exactly 1 week after receiving the vaccine the injection site became significantly inflamed, itchy, warm to the touch, and very warm to the touch. I never ran a fever but have become concerned about infection at the site of injection. My upper right arm at the largest portion of the muscle is at a circumference of 15 1/4 inches and my left is 16 3/4 inches at it's largest.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PUB,Vitamin D and Vitamin C Oracea - 40mg Fluoxetin -10mg,none,rosacea of face,,none,"['Discomfort', 'Injection site erythema', 'Injection site inflammation', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 927240,WI,51.0,F,Itching at injection site that began 7days after the injection. A red puffy area developed the next day. It is oval shaped about 2 inches by 1.5 inches and is itchy. I have used one application of topical Benadryl and it has not helped.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,01/06/2021,36.0,WRK,"Tums, vitamin D",None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 927242,TN,53.0,F,"Injection site redness, itching, swelling, and pain began 6 days after injection. Redness has expanded over last 2 days. Have been treating myself with over the counter Advil, Benadryl, & Pepcid",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,OTH,4000 IU Vitamin D,None,Atopic dermatitis,,None known,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 927243,MO,,U,"Fever, Headache, Body Aches, tiredness � 2 days finds, Tylenol and ibuprofen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,PVT,,,,,,"['Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 927244,NV,28.0,F,Swelling pain redness hives heat,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,WRK,"Cymbalta, LDN, microgestin, zinc, astralagus, vitamin c, mushroom defense, lysine, klonopin",None,Fibromyalgia,,None,"['Erythema', 'Feeling hot', 'Pain', 'Swelling', 'Urticaria']",1,MODERNA,IM 927245,NJ,48.0,F,"redness swelling ,pain, heat, hard, itching to upper arm arm that began on the 7th day after the vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,metoprolol Effector XR,none,hypertension Mitral value prolapse Bi polar disorder,,augmentin,"['Erythema', 'Induration', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Skin warm']",1,MODERNA,IM 927246,PA,49.0,F,"About 1.5 hours after injection: migraine, bad sinus pressures, major fatigue and chills. All symptoms lasted about 22 hours. I still have a minor headache and fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Metformin, zolpidem, venlafaxine, topiramate, rizatriptan as needed, solifenacin succinate, B12 monthly injection, vitamin D, multivitamin, Tylenol",None,"Diabetes, lymphedema in both legs, spinal stinosis, arthritis in both knees, complete alc tear in right knee",,"Naproxen Sodium, adhesive","['Chills', 'Fatigue', 'Headache', 'Migraine', 'Paranasal sinus discomfort']",1,PFIZER\BIONTECH,SYR 927247,TX,67.0,M,"Patient complained of sweaty hands, ""unsettled stomach"" after vaccination. Patient checked out by EMS, began feeling better shortly thereafter. Patient advised to call emergency services or go to the nearest emergency room for any additional issues as needed. Also advised to sign up for v-safe. Patient left site stating he felt better.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PUB,,,Hypertension,,,"['Abdominal discomfort', 'Hyperhidrosis']",1,MODERNA,IM 927249,TX,48.0,M,"1010: Informed patient feeling tired, dizzy and warm feeling to chest/neck/head: BP: 152/94; HR:80; RR:20; O2 sat:99%; remained with patient. Patient was able to hold a conversation and knew where he was at. 1015: BP:160/94;HR:72;RR:22; O2 sat:99%; patient stated he was feeling better after placed in a cot in a supine position; applied a cool, wet towel to posterior neck. Asked patient if he wanted something to eat/drink and he responded he did. Drink, cookies/snacks given to patient. Tolerated snacks/drink w/o complications 1020: BP:162/94: HR:68; RR: 24; O2 sat:99%; remained with patient, stated he was feeling better but now feeling fuzzy brained, confused and pins/needles to bilateral extremities. 1040: BP: 152/90; HR:68; RR:20; O2 sat 99%; Patient indicated he needed to go to restroom; a male staff took patient to restroom, no problems, no dizziness. This nurse did not want patient driving home so he called his wife. 1050: BP:154/88; HR:70; RR:18; O2 sat 99%; patient stated he was feeling much better and no longer had the confusion feeling or the pins/needles feeling to bilateral lower extremities. 1115: BP:148/90; HR:70; RR:16; O2 sat 99%; patient's wife showed up and he was discharged to her care. This nurse informed patient wife what had happened and she verbalized understanding. Patient ambulated out with this nurse and difficulty. Patient placed in car and he was able to place seatbelt on himself. Airway never compromised at this visit. 1920: this nurse called and left message for patient to report how he was feeling 1940: Patient called and stated he was feeling really good. Stated he had not answered because he had gone to pick up his car from the COVID-19 clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,Wellbutrin Metformin Viibryd,None,Hypercholesteremia High Blood Pressure Diabetes - Type 2 Depression,,None,"['Confusional state', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Paraesthesia', 'Skin warm']",1,MODERNA,IM 927250,NC,49.0,F,These symptoms began at 11:23 am and still present at the time this form is being filled out. Vertigo Nausea (no vomiting) Chills (no fever) Tremors Headache Approximately 5 hours after injection: (still present at time of filling out this form) Pain in left upper arm at injection site down arm. Muscular pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PUB,Effexor Nuvigil,None,Viral Meningitis Depression,,Sulfa Morphine Stadol,"['Chills', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Tremor', 'Vertigo']",1,MODERNA,IM 927251,TN,59.0,F,"9th day post vaccine., red, swollen and itchy at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,"Losartan, Spiriva, Breo, Simvastatin, Montelukast, Citalopram, Omeprazole",Upper Respiratory Infection,"HTN, Asthma, Allergies, Hypercholesterolemia, GERD, Anxiety",,Lisinopril,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",2,MODERNA,IM 927252,TX,64.0,F,"Swelling, large raised area at vaccine site. Hot to touch, uncomfortable. Symptoms began at 8pm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,none,none,COPD,,none,"['Injection site swelling', 'Skin warm']",1,MODERNA,SYR 927253,CT,42.0,F,"Headache Nausea Fatigue noticed at 9 am on 1-7-2021, Fever 100.4-101 F started at 6 PM.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"Levothyroxine, Metoprolol, Tytlenol",none,Hypothyroidism Asthma,,no,"['Fatigue', 'Headache', 'Nausea', 'Pyrexia']",1,MODERNA,IM 927254,TX,29.0,F,Patient received vaccine at a drive-through event. As she parked her car she saw another vaccine recipient walking to the ambulance for treatment and started feeling very anxious with a faster heart rate. RN spoke to patient on site and she had no other complaints. Patient monitored for a total of 30 minutes without further complaint. Patient advised to call emergency services or go to the nearest emergency room for any additional issues if needed. Also advised to sign up for v-safe. Patient left site stating she was feeling better (also saw other vaccine recipient return to car quickly and she said that helped).,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PUB,,,,,,"['Anxiety', 'Heart rate increased']",1,MODERNA,IM 927255,IL,36.0,F,"On day 8 post injection, site became sore and reddened with mild edema present . Site is warm to the touch. Area is being monitored and has not increased in size.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,01/06/2021,36.0,PUB,Multivitamin,None,None,,PCN/Latex,"['Injection site erythema', 'Injection site oedema', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 927256,OR,41.0,F,My arm was sore for the first 3 days which was not unusual. The pain completely resolved. Now 8 days later I woke up with a sore arm that is warm to touch and some swelling. I also have a rash and redness on the arm where I recieved the vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,None,None,None,,None,"['Injection site erythema', 'Injection site rash', 'Pain in extremity', 'Peripheral swelling', 'Skin warm']",1,MODERNA,SC 927257,ID,24.0,F,"10 minutes after vaccine was given, patient had onset of throat tightness, difficulty breathing, flushing, and rash. Patient was immediately treated with 0.3 mg of epinephrine and within approximately 60 seconds began having improvement in her symptoms. EMS was called and patient was taken to the ER via EMS for ongoing observation. Patient was feeling improved but not back to baseline prior to leaving the clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"EpiPen, Wellbutrin, Sertraline, Montelukast, Sprintec",None,None,"Hives to flu vaccine with preservatives, no reaction to flu vaccine without preservatives","Shellfish, Sulfa drugs","['Dyspnoea', 'Flushing', 'Rash', 'Throat tightness']",1,MODERNA,IM 927258,TX,50.0,F,"Patient complained of being nauseous, dizzy, weak and fatigued immediately after immunization. Patient checked out by EMS, began feeling better shortly thereafter. Patient advised to call 911 or go to the nearest emergency room for any additional issues as needed. Also advised to sign up for v-safe. Patient left site stating she already feeling better.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PUB,,,,,,"['Asthenia', 'Dizziness', 'Fatigue', 'Immediate post-injection reaction', 'Nausea']",1,MODERNA,IM 927259,VA,51.0,F,"AT 7:45 AM ON SATURDAY, 01/02/2021, I STARTED HAVING DIZZINESS, LIGHT-HEADEDNESS, AND PALPITATIONS. THE MORNING OF 01/05/2021, I DEVELOPED CHILLS WITHOUT FEVER. WENT TO MY FAMILY PRACTICE, LIFETIME MEDICINE, AND WAS SEEN BY NIDA ARIF, PA FOR ABOVE PERSISTING SYMPTOMS. AN EKG WAS DONE IN THE OFFICE RESULTING IN NORMAL SINUS RHYTHM. AS OF 01/06/2021, CHILLS, DIZZINESS AND LIGHT-HEADEDNESS RESOLVED. PALPITATIONS CONTINUE TO PERSIST AS OF 01/07/2021 WHEN THIS REPORT WAS FILLED OUT AND SUBMITTED.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/02/2021,1.0,PVT,"NORVASC 5MG DAILY OTC MULTIVITAMIN, VITAMIN C, VITAMIN D, CALCIUM",NONE,HYPERTENSION,,CIPRO AVOCADO LATEX,"['Chills', 'Dizziness', 'Electrocardiogram normal', 'Palpitations']",1,PFIZER\BIONTECH,IM 927260,WI,87.0,F,"No adverse effects noted after vaccination. Patient with cardiac history was found unresponsive at 16:45 on 1/6/21. Abnormal breathing patterns, eyes partially closed SPO2 was 41%, pulseless with no cardiac sounds upon auscultation. CPR and pulse was regained and patient was breathing. Patient sent to Hospital ER were she remained in an unstable condition had multiple cardiac arrest and severe bradycardia and in the end the hospital was unable to bring her back.",Yes,01/06/2021,Not Reported,Yes,1.0,Not Reported,N,12/28/2020,01/06/2021,9.0,SEN,"Vit D3, Miralax, Spironolactone, Tramadol, Metoprolol Succinate, MOM, Ferrous Gluconate, Ondansetron, Nitroglycerin Sublingual PRN, PreserVision AREDS, Fluticasone Propionate Suspension, Lisinopril, Clopidogrel Bisulfate, Campor-Methol-Met",Digestive Surgery for bowel obstruction,"HTN, AAA, Chronic Diastolic Heart Failure, Diabetes Type 2, Paroxysmal atrial fibrillation, bradycardia, Hx of STEMI, Hx of CVA, HX of uterine cancer,",,"Codeine, Meperidine, Morphine, Estrogens, Penicillins, Tetanus Toxoids","['Blood lactic acid increased', 'Bradycardia', 'Cardiac arrest', 'Computerised tomogram head normal', 'Death', 'Heart sounds abnormal', 'Pulse absent', 'Respiration abnormal', 'Resuscitation', 'SARS-CoV-2 test negative', 'Unresponsive to stimuli', 'White blood cell count increased']",1,MODERNA,IM 927261,TN,25.0,F,"Severe skin burning and irritation. Severely red/raw blotchy rash all over extremities. It started the day after the vaccine by the second day it has spread all down my legs and arms, and very painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2020,01/06/2021,367.0,WRK,None,Covid-19 in month of December.,None,,None,"['Erythema', 'Pain in extremity', 'Rash', 'Rash macular', 'Skin burning sensation', 'Skin erosion', 'Skin irritation']",1,MODERNA,IM 927262,ID,24.0,F,"10 minutes after vaccine was given, patient had onset of throat tightness, difficulty breathing, flushing, and rash. Patient was immediately treated with 0.3 mg of epinephrine and within approximately 60 seconds began having improvement in her symptoms. EMS was called and patient was taken to the ER via EMS for ongoing observation. Patient was feeling improved but not back to baseline prior to leaving the clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"EpiPen, Wellbutrin, Sertraline, Montelukast, Sprintec",None,None,"Hives to flu vaccine with preservatives, no reaction to flu vaccine without preservatives","Shellfish, Sulfa drugs","['Dyspnoea', 'Flushing', 'Rash', 'Throat tightness']",1,MODERNA,IM 927263,CA,27.0,F,"Patient received first dose of Moderna Vaccination at 15:32. Approximately 30 minutes later patient began feeling itchiness in her throat and anxious. Pt was placed on a Non-rebreather at 15 L. Pt's vitals were BP: 134/81, HR: 113, O2: 100% on 15 L NR, RR: 26. PA at bedside with verbal order for Epinephrine 0.3 mg. EpiPen give to left upper thigh at 16:32. Pt's heart rate increased to 110's-140's. Pt's itchy throat remained the same. Pt began having symptoms of a dry throat as well. Pt administered Benadryl per PA at 16:40. Pt began experiencing nausea at approximately 16:50. Zofran 4 mg ODT administered sublingual at 16:50. EMS was activated and arrived approximately 16:55. Report given and pt transferred to ECRMC for further workup and assessment. Vitals remained stable throughout.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,Montelukast 10 mg Cetirizine 5mg/Pseudoephedrine 120mg Sertraline 100 mg Tylenol 325 mg,Generalized Anxiety Disorder,Generalized Anxiety Disorder,,NKA,"['Anxiety', 'Dry throat', 'Nausea', 'Throat irritation']",1,MODERNA,IM 927264,CA,39.0,F,"Moderna COVID?19 Vaccine EUA fever, pain, edema and swollen lymph node",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,,,,,,"['Lymphadenopathy', 'Oedema', 'Pain', 'Pyrexia']",1,MODERNA,IM 927265,WA,38.0,F,"Low grade fever, site soreness, fatigue, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,Clorthalidone. Losartan,None,Hypertension,,Compazine,"['Fatigue', 'Headache', 'Injection site pain', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 927266,FL,26.0,F,"Day 1: Itching began about 30-40 minutes after injection. Welts began appearing 2 hours later on arms, legs, and back. Took Benadryl 36.5 mg every 4 hours. Day 2: Woke up with hives all over body, including face , started Prednisone 10 mg x3 tablets and continued benadryl 25mg every 3-4 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,None,"None one month prior, history of COVID September 12th 2020.",None,,None,"['Pruritus', 'Urticaria']",1,MODERNA,IM 927267,TX,3.0,F,Acute cerebellar ataxia,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,11/06/2020,11/13/2020,7.0,PVT,Children?s multi vitamin,None,None,,None,"['Cerebellar ataxia', 'Electroencephalogram', 'Lumbar puncture', 'Magnetic resonance imaging']",UNK,GLAXOSMITHKLINE BIOLOGICALS, 927268,OR,53.0,F,axillary and arm pain on date of immunization and also myalgias and low grade temperature of 100.1 on 1/5/21 develop facial and neck swelling and redness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,multivitamin,none,none,,"mango causes oral mucosal swelling, question of allergy to amoxicillin (details unclear)","['Axillary pain', 'Body temperature increased', 'Erythema', 'Myalgia', 'Pain in extremity', 'Swelling', 'Swelling face']",1,MODERNA,IM 927269,NH,43.0,F,"Moderna COVID-19 Vaccine EUA Oval, red, raised skin around injection site @ 8 days post vaccination. Slight soreness and itching. 9 days post vaccination; red area has increased in size, approx 5 x 2 inches. Swelling and redness very slightly reduced. Itching and soreness the same. Staff health examined but had no conclusive treatment. Four other employees called to report similar reactions from the same vaccine clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,flonase nasal spray 1x/day,"cold symptoms 3 weeks prior, negative covid test result",none known,,none known,"['Injection site erythema', 'Injection site swelling', 'Pain', 'Pruritus']",UNK,MODERNA,IM 927270,MN,27.0,F,Muscle/joint soreness to the extent that the patient is unable to dress herself/complete basic activities of daily living without assistance. ***Patient is an RN. Injection site appears to have been given outside of the deltoid muscle (too high),Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,WRK,Daily Multivitamin,None,None,,Doxycycline,"['Arthralgia', 'Loss of personal independence in daily activities', 'Myalgia', 'Product administered at inappropriate site']",UNK,MODERNA,IM 927271,IN,27.0,F,Severe chills that started about 11 hours after the injection. Moderate muscle aches.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Chills', 'Myalgia']",UNK,MODERNA, 927272,AK,56.0,F,"Patient received COVID vaccine at 0939, during observation period reported tingling of tongue and lips approx. at 1010. Benadryl 25mg by mouth administered. Patient continued to be monitored for additional 1hr. Benadryl improved symptoms, patient denied SOB and remained calm throughout. Swelling and tingling improved. Patient went back to work in hospital where received vaccine. Patient confident in monitoring return of symptoms while on site working. Patient reports list of allergies and has dealt with symptoms of allergic reactions before. This RN checked on patient after vaccine clinic and residual tingling remained but otherwise patient ""felt good"". Called patient at 1707 to follow up. Patient reports minor residual burning on lip otherwise other symptoms resolved. Continues to denies difficulty breathing, "" I feel fine""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,,,,,"nuts, raw fruit/vegetables due to birch tree allergy, oral latex sensitivity, carrots (raw and cooked) coconut, environmental allergies : birch, maple, alder trees, cats and dogs. antibiotics, and some pain medications adverse effects from general anesthesia and sun exposure","['Oral discomfort', 'Paraesthesia oral', 'Swelling']",1,PFIZER\BIONTECH,IM 927273,FL,71.0,F,Rash on Chest and Arms,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,PVT,Amlodipine,none,none,,none,['Rash'],1,MODERNA,SYR 927274,NY,52.0,F,"Temperature 103.1, chills, muscle and joint pain, fatigue, weakness dizziness, headache, nausea rest and fluids, acetaminophen started at 0400 am on 1/6 symptoms started to resolve by 2000 (8pm) on 1/6",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,metoprolol 25mg daily zoloft 25mg daily norvasc 5 mg daily vitamin D 2000 international units daily Vit B complex daily,none,hypertension,,none,"['Arthralgia', 'Asthenia', 'Body temperature increased', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Nausea']",UNK,PFIZER\BIONTECH,IM 927275,PA,51.0,F,"Fever, headache, fatigue, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,OTH,Multi vitamin. Probiotics,,,,,"['Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 927276,PR,41.0,F,"Itching at the injection site, then the area became red, hot, swollen and tender. Treatment: cold press",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,OTH,Vitamin D B Complex Vitamin C EmergenC,None,None,,Aspirin Sulfa,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 927277,CO,28.0,F,"Mouth numbness, elevated bp and pulse, severe chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PHM,,none,hx of panic attack,,"bananas, kiwi, latex","['Blood pressure increased', 'Chills', 'Heart rate increased', 'Hypoaesthesia oral']",1,MODERNA,IM 927278,CA,41.0,F,I broke out in full body rash resembling hives 6 days after receiving vaccine. Rash was very itchy and spread to nearly whole body. I was seen by PMD on 1/5/2021 and prescribed prednisone burst (50mg qday X 5days) as well as topical steroid cream and also Zyrtec.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,PVT,None,None,None,,None,"['Rash', 'Rash pruritic']",1,MODERNA,IM 927279,NY,35.0,F,"The patient presented on the 9th day post-vaccine administration with a significant 7 cm x 5 cm firm urticarial lesion at the site of her vaccination with pruritus and surrounding erythema. Prior to this point, she was asymptomatic other than a small amount of soreness at the vaccination site with no reaction, lesions or pruritus.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,PVT,2. ALPRAZolam Tab 0.5 mg sig: one tablet orally one time daily as needed for anxiety 3. Fluticasone Propionate Nasal Suspension 50 MCG/ACT sig: 4. Lexapro Tab 20 mg sig: 1 tablet orally every day 5. multivitamin sig: one orally daily 6. Par,NONE,"Anxiety, Thyroid nodule",,No known allergies,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site urticaria']",1,MODERNA,IM 927280,TX,49.0,F,"3? x 3? red, swollen, warm itchy patch at injection site. No treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/06/2021,6.0,WRK,"Testosterone, hydroxyzine 10mg, rosuvastatin, Claritin, b complex, vitamin c, vitamin e, NAC, zinc, copper, magnesium, ashwaganda, 5 HTP, gelatin caps.",None,None,,"Buckwheat, erythromycin","['Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA,IM 927281,WI,44.0,F,"Did really have any reaction until 1/07/21. Woke up with my arm throbbing, then noticed my arm was super warm to touch, very red, as the day went on the symptoms progressed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,IBUPROFEN,None,"Asthma, fibromyalgia, arthritis",,Sulfa drugs and cymbalta,"['Erythema', 'Pain', 'Pain in extremity', 'Skin warm']",1,MODERNA,SYR 927282,GA,47.0,F,"Initially I had normal side effects of pain, swelling, redness at the injection site for three days from 12/31/2020-1/2/2021. The symptoms resolved. Then I experienced itching at the injection site late 1/6/2021 after reporting V-safe. On 1/7/2021 I woke up with itching, redness, swelling. As the day progressed the injection site was red, indurated (6 cm x 4 cm), painful, itchy. I contacted my doctor's office and received antibiotics for cellulitis.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,WRK,"lovastatin, pantoprazole, doxepin",None,None,,None,"['Injection site cellulitis', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 927283,WV,66.0,F,Patient complained of bilateral hand swelling and swelling in the left neck area. No itching or pain. No rash. No fever. No swelling of tongue or lips. No dyspnea or wheezing. Symptoms dissipated over 24 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Peripheral swelling', 'Swelling']",UNK,PFIZER\BIONTECH,IM 927284,WV,48.0,M,swollen neck lymph node of left side. Lymph node still swollen at day 20 and continuing.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/19/2020,1.0,PUB,Vitamin c Lisinopril 20,none,none,,none,['Lymphadenopathy'],1,PFIZER\BIONTECH,IM 927285,NH,44.0,F,"On day 8 my arm was itchy then turned red , swollen ,hard and warm to the touch...I drew A circle and by the end of the day it grew quite a bit..i was seen in my Occupation Health Office and was prescribed Clymdamicin for possible cellulitis..I will monitor and follow-up with my PCP",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,WRK,Lexapro. Linsopril,No,No,,PCN and Sulfa,"['Erythema', 'Induration', 'Peripheral swelling', 'Pruritus', 'Skin warm']",1,MODERNA,IM 927286,WI,39.0,F,"1st night severe rash over torso, arms, and face. 2 days later vomiting and diarrhea. The whole week after vaccine horrible migraines.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,B-12,,,,Compazine,"['Diarrhoea', 'Migraine', 'Rash', 'Vomiting']",1,PFIZER\BIONTECH,SYR 927287,CO,34.0,M,"Itchy rash developed in the early afternoon on injection day. Rash persists and got worse four days later. Rash began on upper arm of injection site and spread throughout the body including both upper arms and forearms, shins, calves, side of torso",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,"Men?s probiotic, men?s daily vitamin, Prevacid",N/a,"Irritable Bowl, asthma",,Mustard Peanut Tree nuts Pineapple Ragweed Mold Grass,"['Injection site rash', 'Rash', 'Rash pruritic']",1,MODERNA,SYR 927289,NC,52.0,F,Shortness of breath and wheezing,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Metoprolol, Ezetimibe, Levoxyl, Pepcid, Xyzal, Linzess, Reglan, Lipitor, Metformin, Protonix, Imdur, Losartan, Singular, Prednisone, VitaminD, Calicum, Multivitamin, Aspirin",,"Diabetes, Asthma, High Blood Pressure, High Cholesterol, Hypothyroidism, GERD","Only with allergy shots, caused asthma attack.",Ace inhibitors and Cantin,"['Dyspnoea', 'Wheezing']",1,PFIZER\BIONTECH,IM 927290,TN,33.0,F,"Eyelid swelling on one side, which was the side of vaccination, 8 hours after the dose, quite visible but only mildly bothersome",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,None,Covid diagnosed 12/19 (2 days after vaccine dose1),None,,None,"['COVID-19', 'Swelling of eyelid']",2,PFIZER\BIONTECH,IM 927291,CA,46.0,F,"Pfizer vaccine 12/19. Reports intermittent dizziness, brain fog, severe headaches, nausea, shortness of breath, left axillary lymphadenopathy, elevated blood pressure which onset on 12/31. COVID-flu negative, normal labs, CT thorax and brain MRI negative. Has been to ED and is returning today due to continued symptoms. Reported symptoms to VSafe",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/31/2020,12.0,PVT,,,,,SILVADENE MOTRIN SULFA,"['Blood pressure increased', 'Computerised tomogram thorax normal', 'Dizziness', 'Dyspnoea', 'Feeling abnormal', 'Headache', 'Influenza virus test negative', 'Laboratory test normal', 'Lymphadenopathy', 'Magnetic resonance imaging brain normal', 'Nausea', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 927292,PR,28.0,F,"Rash (purple points) in my left leg, appears two days after the vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,UNK,None,None,None,,None,['Rash'],1,MODERNA,SYR 927294,OH,32.0,F,"Fever (99.6F, my baseline is 97.6F) developed wround 3pm 1/7/2021 - joint pain 6/10 without meds (begane around 11pm and worsened overnight.) - body aches developed by morning - fatigue (all say 1/7/2021, 2 hour nap, 8 hours of sleep at night, still fatigue. Worked 1/2 day) Discontinued meloxicam to alternate between acetaminophen and ibuprofen. Fever will decrease. Joint pain becomes 4/10",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,Vit D Meloxicam Allegra Xyzal Qnasl Mirena,Treated for bacterial upper respiratory infection 12/9/2020,Ehlers-Danilo?s Syndrome,Leg stiffness and difficulty walking following hepatitis B (5/6 years old) Extreme fatigue and malaise day after flu shot every ,Mold Cats and dogs Peas Coconut Onion,"['Arthralgia', 'Fatigue', 'Pain', 'Pyrexia']",1,MODERNA,SYR 927296,KS,21.0,M,Moderate to Severe Stomach cramps,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PUB,,,,,Penicillin,['Abdominal pain upper'],1,MODERNA,IM 927297,OH,36.0,F,"I am a healthcare provider. I had prophylactically premedicated with Tylenol prior to receiving my covid-19 vaccine. Immediately following the vaccine I had mild / moderate pain at injection site and muscle soreness at injection site. Roughly 20-24 hours after receiving the vaccine, I developed moderate headache, fatigue, fogginess, full body aches, nausea and upset stomach. I continued on Tylenol twice daily. After a good night?s sleep, I felt better the following morning and all symptoms had resolved within 48 hours post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"Lialda 2.4g bid, plaquenil 200mg bid, Tylenol 1000mg bid, vitamin d 2,000IU daily",None,"SLE, ulcerative colitis, migraine headaches",,Bismuth (pepto bismol),"['Abdominal discomfort', 'Fatigue', 'Feeling abnormal', 'Headache', 'Injection site pain', 'Nausea', 'Pain']",1,MODERNA,IM 927298,NY,57.0,M,"Dizziness, nausea, fever, night sweats",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,"Metoprolol, levothyroxine, atorvastatin, aspirin, Centrum Silver men?s Vitamin, vitamin C, zinc",None,"A fib, asthma",,Nkda,"['Dizziness', 'Nausea', 'Night sweats', 'Pyrexia']",UNK,MODERNA,IM 927299,CO,36.0,F,"Fever, chills, arthralgias",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,None,None,None,,None,"['Arthralgia', 'Chills', 'Pyrexia']",2,PFIZER\BIONTECH,IM 927300,MD,26.0,F,"Swelling of injection site was still visible after eight days. Site is approximately 4 inches in diameter, raised, firm, and warm to the touch. No fever or other noticeable symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PVT,Adderall 20 mg Lexapro 20 mg,None,None,,Ceclor,"['Injection site induration', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 927301,IN,46.0,F,Fever 36-48 hours Headache Chills Nausea Aches/ sore muscles,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Trulicity Lisinopril,,,,Na,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 927302,NY,34.0,M,"20 minutes after got a rash in the neck, took allegra 180mg, same day 1 hour after same left arm pain, next day shivers, chills, body aches took Tylenol 1gr every 8 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Tylenol 1 gram once allegra 180mg once after the rash and hive,None,"GERD, Take Esomeprazole 40mg BID",,Ibuprofen,"['Chills', 'Pain', 'Pain in extremity', 'Rash']",2,PFIZER\BIONTECH,IM 927303,TX,67.0,M,"On day1st Very Sore and Painful arm by evening started with chills Day 2 chills, fever, over 100 and lethargic, body ache Day3 when visited physician head Headache, fever and high blood pressure which is still persistent after day5",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,PVT,"Crestor10mg, Aspirin81mg, Vitamin c, omega fish oil",None,High cholesterol,,None,"['Chills', 'Headache', 'Hypertension', 'Lethargy', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SC 927304,NV,31.0,F,"48 hours post vaccine I started having sore throat, cough, fever for the next three days. Later I got tested positive. 5 days after vaccine I was experiencing SOB but all symptoms were gone after 10 days post injection. Not sure if I was exposed to people with covid prior to receiving the vaccine. I also do work with covid patients at work",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,PVT,OTC Tylenol,None,None,,None,"['COVID-19', 'Cough', 'Dyspnoea', 'Oropharyngeal pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 927305,CA,44.0,M,Fever - 100.7,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,Atenolol,None,HTN,,None,['Pyrexia'],UNK,PFIZER\BIONTECH, 927306,IN,56.0,M,"At around 10pm.i began to feel warm, began to experience a nasty headache, chills , myalgias, and this continued for about 30 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Zero,Zero,Zero,Shingrix,Zero,"['Chills', 'Feeling hot', 'Headache', 'Myalgia']",1,MODERNA,IM 927307,FL,58.0,M,"ear fullness and loss of hearing on left ear, 4 days after getting vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/02/2021,5.0,UNK,,,,,,"['Deafness unilateral', 'Ear discomfort']",UNK,MODERNA, 927308,TX,80.0,F,"rash all over body started day after vaccine administration, spreading",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Losartan, Synthroid, Premarin",none,"hypertension, hypothyroidism, polymyalgia rheumatica, hormone replacement therapy",,"vancomycin, codeine",['Rash'],1,PFIZER\BIONTECH,IM 927309,CA,57.0,F,Sore arm hard lump and mild rash in vaccination site. Headache for week then turning into migraine headache. By day 9 all symptoms have subsided,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,,None,High blood pressure,,"Kiwi, Penicillin","['Headache', 'Migraine', 'Pain in extremity', 'Vaccination site induration', 'Vaccination site pain', 'Vaccination site rash']",1,MODERNA,SYR 927310,OH,54.0,F,"Blood in stool, lots of blood",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,Eliquis Fish oil B-12 Iron,None,Factor 5 clotting disorder,,Penicillin Demerol Clindamycin,['Haematochezia'],1,MODERNA,IM 927311,MA,39.0,F,"Received Moderna COVID-19 Vaccine EUA - one day later had redness, swelling and pain circling about 1 inch around the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,,,,,bactrim,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 927312,PR,32.0,F,"About 5 min after the administration of the second dose of the vaccine I began to experience tachycardia, difficulty to breath, sweating, numbness in arms and legs and trembling of limbs. I have not history of allergies.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,Protonix 40mg po daily Pepcid 20mg po daily,,,,Penicillin Sulfa,"['Dyspnoea', 'Hyperhidrosis', 'Hypoaesthesia', 'Tachycardia', 'Tremor']",2,PFIZER\BIONTECH,IM 927314,VA,33.0,F,"Malaise, fever of 100.6, chills, feeling of shortness of breath, headache, myalgias, arthralgias Lasting less than 6 hours Relieved by oral antiflammatory",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,None,None,None,,None,"['Arthralgia', 'Chills', 'Dyspnoea', 'Headache', 'Malaise', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 927315,MO,53.0,F,"fever, headache, chills, body aches--alternating tylenol and Ibuprofen, rest, staying hydrated x 2 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"lisinopril, toujeo, synjardy, pravastatin, xarelto, glipizide, mirtazipine, duloxetine, bupropion",None,"Type 2 Diabetes, Hypertension, Depression",,latex,"['Chills', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 927316,IL,29.0,M,20 hours after injection I experienced swelling of both hands as well as very itchy palms. This lasted 1 hour and subsided on it's own. No intervention.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"Escitalopram, centrum multi vitamin, L-arginine, caffeine",None,None,,None,"['Peripheral swelling', 'Pruritus']",1,MODERNA,IM 927317,IN,30.0,F,"Body aches, headache starting at 10:00 pm and persisting through the following evening (approximately 24 hours)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,"Adderall xr 20 mg, IR 10 mg Zytrec, Flonase",None,None,,None,"['Headache', 'Pain']",1,MODERNA,IM 927318,CT,44.0,M,"Received Moderna COVID vaccine yesterday (1/6) at 8:10 am. After about 3 hours, began to experience dizziness, nausea and fatigue that progressively worsened throughout the day. Went home after work, fell asleep and did not eat dinner due to lack of appetite from nausea and dizziness. Woke up in AM following day (1/7), feeling somewhat better, but still slightly dizzy. Appetite has returned and was able to eat regular meals today.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Daily multivitamin (Centrum),none,none,,none,"['Decreased appetite', 'Dizziness', 'Fatigue', 'Nausea']",1,MODERNA,SYR 927319,NE,42.0,F,"noticed a warm, hard, painless, itchy area at injection site several days after the pain from the injection had resolved. it is not painful, but it is tender to touch, it is about 2.5 cm across, and circular in shape",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,"Zoloft, Melatonin, Benadryl",,depression,,none,"['Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 927320,OH,29.0,F,"The injection site was itchy and upon further inspection is red, tender, and swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,PVT,Mirena IUD,None,None,,NKA,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 927321,CA,,U,Rash at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,PUB,,,,,,['Injection site rash'],1,MODERNA,IM 927322,TX,29.0,F,"Tachycardic 145, SOB, headache, nausea, fatigue, fever, weak, dizzy, ground glass lungs suspicious infiltrate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Vitamins,"Covid +, pneumonia, atelectasis, myocarditis, pleurisy.",Short of breath and tachycardia,,None,"['Asthenia', 'Condition aggravated', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Headache', 'Laboratory test', 'Lung infiltration', 'Nausea', 'Pyrexia', 'Tachycardia', 'X-ray abnormal']",UNK,MODERNA,IM 927323,NV,31.0,M,"Fever 100.8, shortness of breath, chills, myalgias, weakness, shortness of breath worse with exertion, chest tightness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Asthenia', 'Chest discomfort', 'Chills', 'Dyspnoea', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 927324,FL,44.0,F,"7 days after injection, site became swollen, red, warm and itchy. Remained red and warm for 1-2 days. Also, 2 other areas within 3 inches, on arm became red and warm. Eyes became itchy, blood shot, irritated, 3 days after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,PVT,"sertraline, levothyroxine, vitamin D, B12, Claritin",,Hashimoto's hypothyroidism,,,"['Eye irritation', 'Eye pruritus', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Ocular hyperaemia']",1,MODERNA,IM 927325,CA,50.0,F,"one wk later arm painful, large lymph note at site of injection and myalgias.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,WRK,nothing,none,none,,NKDA,"['Myalgia', 'Pain in extremity']",UNK,MODERNA,IM 927326,OH,60.0,F,2 hours after my vaccine. My right side of my neck became stiff from the back of my head all the way to right shoulder. Lasted for 24 hours. Then I slept for 17 hours straight and had malaise and fatigue for 6 days after that. I am still with low energy level and my mood I'd irritatabl. Now with a small amount of swelling on left side of lip which is not getting bigger but lip feels thick. Bilateral cheeks slight swollen.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,None,None,None,,NoneNone,"['Fatigue', 'Irritability', 'Lip swelling', 'Malaise', 'Musculoskeletal stiffness', 'Swelling face']",1,MODERNA,IM 927327,WA,57.0,F,"Severe body/joint aches and fatigue, chills, headache, abdominal pain/distension",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,PVT,"Citalopram, omeprazole, losartan, hctz, vitamin d, glucosamine/msm, armory thyroid, lovastatin, fishpond, ca/mg, multivitamin, potassium",None,"High blood pressure, gerd, thyroid, depression",,"Sulfa, penicillin, erythromycin","['Abdominal distension', 'Abdominal pain', 'Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Pain']",1,MODERNA,IM 927328,ID,34.0,F,"Swelling, redness, itching, hot to touch, swollen lymphnode in left underarm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/06/2021,10.0,PVT,"Losartan, Junel, trintellix, spironolactone",None,Hypertension,,None,"['Erythema', 'Lymphadenopathy', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,SYR 927329,,55.0,F,"12/30: noticed redness, warmth, soreness to left upper arm (injection site) Since 12/30 to current, the left upper arm is still tender to touch with the same redness. Taking over the counter meds.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,UNK,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 927331,,50.0,F,"12/29/2020- received Moderna vaccine- felt mild tingling sensation in gums that resolved in 15 min Jan 2 - Mild itchiness to injection site with soreness Jan 7 - itchiness in throat and felt a lump in throat, also noticed tingling in gums Symptoms have resolved after taking over the counter medication",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,UNK,,,,,,"['Injection site pain', 'Injection site pruritus', 'Paraesthesia oral', 'Sensation of foreign body', 'Throat irritation']",1,MODERNA,IM 927332,AL,42.0,F,"24 hours after injection -injection site moderately sore 48 hrs - site sore and itchy 7 days - red, swollen/hard and itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,PVT,Zyrtec Vyvanse Omeprazole,,Asthma,,Erythromycin Levaquin,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 927333,KY,34.0,F,"Shortness of breath, asthma attack, headache, muscle aches, joint pain, sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"Gabapentin, Nexium, Xyzal, Singular, Klonopine",,"IBS, GERD, Asthma, Cramp fasciculation syndrome",,"Z-pak, Penicillin","['Arthralgia', 'Asthma', 'Dyspnoea', 'Headache', 'Myalgia', 'Oropharyngeal pain', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,IM 927334,IL,50.0,F,"severe headache, joint pain, muscle aches, chills, increased heart rate",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Prevacid, Flonase, Astelin, Fosamax, Hydrodiuril, Omega-3, Vitamin D, Calcium, Glucosamine/Chondroitin, Claritin",None,Osteoporosis,,Environmental allergies,"['Arthralgia', 'Chills', 'Headache', 'Heart rate increased', 'Myalgia']",1,MODERNA,IM 927335,OH,50.0,F,"Headache(4days), nausea(2days), body ache(3days), fatigue(3days), bruising of the arm injected(5days), hive at injection site for 5days. All symptoms started 24 hours after vaccine was given.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,WRK,,Had covid on the 11/7/2020,Chronic sinus sufferer.,,"Penicillin, codeine, Bactrim, percocet, ultram, oranges, shrimp Allergic to bees","['Contusion', 'Fatigue', 'Headache', 'Injection site urticaria', 'Nausea', 'Pain']",1,MODERNA,SYR 927336,,49.0,F,Patient sitting for about 20 minutes and feet felt hot/on fire; no shortness of breath. BP 118/84; pulse 84; p ox 99%. Has had same sensation when had allergic reaction to bactrim. Monitored for another 15 -20 minutes; took gatorade. Wanting to go home and take liquid benadryl.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Feeling hot'],1,PFIZER\BIONTECH, 927337,MD,34.0,F,"Very mild headache on day of admin of 2nd dose. Difficulty sleeping. Then awoke with intense body aches at 3am could not go back to sleep. Muscle and joint pain, body aches, and intermittent headache with pressure. Still experiencing.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"Started prednisone 3 day taper today but symptomd happened well before and the prednisone actually made me feel better until it wore off, today?s dose is 60mg. Also on. Vyvanse 60mg, ocella (yasmin)",No,No,,"No, sulfa sensitivity","['Arthralgia', 'Head discomfort', 'Headache', 'Insomnia', 'Myalgia', 'Pain']",2,PFIZER\BIONTECH,IM 927338,OR,45.0,F,"Redness, warmth, itching swelling that started 8 days after receiving the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,WRK,Tecfidera,None,MS,,NKDA,"['Erythema', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,IM 927339,AR,55.0,F,"Pharmacist noticed the patient trying to clear her throat and she said she thinks she just needed a drink. When the drink did not help she was given 12.5mg of diphenhydramine at 4:57pm. It was recommended and offered for her to take 25mg of diphenhydramine but patient stated it made her too drowsy. After a few minutes, the patient stated it felt like her throat was tightening so she was given the other 12.5mg of diphenhydramine given at 5:03pm. She stated her heart was racing and her head was pounding. Her blood pressure was 164/72 and pulse 117. She stated her chest was feeling tight and at 5:11 an EpiPen was administered and call to 911.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PHM,"metoprolol succinate 25mg, aspirin 81mg, pravastatin 40mg",,,,None,"['Chest discomfort', 'Headache', 'Palpitations', 'Throat clearing', 'Throat tightness']",1,PFIZER\BIONTECH,IM 927340,TX,38.0,F,"Swelling/ redness/ soreness/warmth on the site of vaccination which started the next day(12/31/2020) up to current day (1/07/2021), also I noticed it is slightly itchy and less sore. I don't have fever or any other reaction, just this one. It has been 8 days and it has not gone away yet, but it is not getting worse. The size of the swelling is the same.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,SCH,none,none,none,,none,"['Injection site pruritus', 'Vaccination site pain', 'Vaccination site reaction', 'Vaccination site swelling', 'Vaccination site warmth']",1,MODERNA,IM 927341,MP,42.0,F,"About 5 minutes after the shot, I started to feel a tightness in my throat. It lasted a couple of minutes and then passed. Then about 45 minutes after I started to feel a heaviness/ache in my upper chest. This feeling continued for days. Around day four I began to have a feeling of great pressure in my throat, particularly when swallowing. I noticed that my heartrate was elevated, but that might have been because the feeling was very stressful. The feeling would increase when I turned my head to the side or put my chin down.This feeling persisted for 3 days. After three days the feeling changed slightly and started feeling more like the sensation one gets when you have food stuck in your throat. As I type this, it is 8 days after the vaccine and I still feel this sensation in my throat.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,Ashwagandha,,,,"Reglan, phenobarbital, doxycycline, cat hair","['Chest discomfort', 'Chest pain', 'Discomfort', 'Heart rate increased', 'Sensation of foreign body', 'Throat tightness']",1,PFIZER\BIONTECH,SYR 927342,TN,33.0,M,Swollen left supraclavicular lymph node - same side as injection,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,"Tylenol, ibuprofen, melatonin",None,None,,None,['Lymphadenopathy'],UNK,PFIZER\BIONTECH, 927344,OR,58.0,F,"runny nose, cough, headache and body aches for five days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,PVT,losaratin,none,none,,morphine,"['Cough', 'Headache', 'Pain', 'Rhinorrhoea', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH, 927345,MA,47.0,F,"ON THE 7TH DAY AFTER THE VACCINE, RED, RAISED RASHES DEVELOPED ON CHEST AND ABDOMEN, AND CONTINUED TO SPREAD ON SIDES OF THE BODY , WAIST AND BUTTOCKS. ON THE 8TH DAY IT CONTINUES TO SPREAD MORE ON GROINS, THIGHS, UPPER BACK AND BILATERAL ARMPIT. BENADRYL TAKEN AND HYDROCORTISONE CREAM APPLIED WITH LITTLE EFFECT, WILL START METHYLPREDNISOLONE TOMORROW",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,SEN,"ATENOLOL, WIXELA INHALER, VITAMINS D,E&C, PROBIOTIC","ASTHMA, HYPERTENSION",ASTHMA,,"CHLORAMPHENICOL, DICLOFENAC, KETOROLAC, SHELLFISH,","['Rash', 'Rash erythematous', 'Rash papular']",1,PFIZER\BIONTECH,IM 927346,WA,77.0,M,"At about 15 minutes post injection patient stated he thought he may feel a little ""wheezy"" Expiratory wheezes in full right lung. No shortness of breath. BP 148/90, Heart rate 63. O2% 98. Temp 98. Peak Flow 350. Dr. saw patient and ordered hydroxyzine 25mg po. Patient was observed another 30 minutes. He remained stable and then discharged at 5:25pm. Patient will contact Dr. if he continues to have symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Azelastine nasal solution Clopidogrel Bisulfate 75mg Donepezil 5mg Flonase Fluoxetine 10mg Fenofibrate 145 mg Glucosamine 500mg Hydrocortisone rectal cream 2.5% Metafolbic Methocarbamol Naproxen Niacin Omeprazole Pravastatin Sodium 40mg Si,Unknown,Allergic Rhinitis Chronic Kidney disease stage 3 Coronary atherosclerosis Hiatal hernia Mild depression Obstructive sleep apnea,,Codeine-nausea,"['Peak expiratory flow rate', 'Wheezing']",1,MODERNA,IM 927347,UT,34.0,F,"I developed a moderately severe headache, body aches, fatigue and nausea within a few hours of the vaccine. These symptoms persisted into the next day, but had decreased in severity after about 24 hours. I still had a mild headache and body aches (specifically back, neck, and R shoulder pain) the next two days. Three days after, I started feeling worse. The headache again became moderately severe, as well as the neck and back pain, fatigue and nausea. This has continued through today (day 8 post-vaccine). I still have a moderately severe constant headache (dull with throbbing with exertion or movement in neck), back and neck pain and stiffness, mild nausea, and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,WRK,Multivitamin,Chest cold Dec 27-29th.,none,,None,"['Arthralgia', 'Back pain', 'Condition aggravated', 'Fatigue', 'Headache', 'Musculoskeletal stiffness', 'Nausea', 'Neck pain', 'Pain']",1,MODERNA,IM 927348,CA,71.0,F,"chills, nausea, headache, bodyaches--treated with fluidsand rest",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,"Colchicin 0.6mg 1 daily x 7 days, ASA 81 mg. 1 daily x 1month, Vitamin C, 12 daily, Vitamin D3-2 daily, Fosamax 70 mg, 1 weekly",Covid 19 -tested positive 12/24/2020,osteoporosis,,codeine sensitivity,"['Chills', 'Headache', 'Nausea', 'Pain']",1,MODERNA,IM 927350,AK,45.0,F,"Was fatigued and had headache since about hour after shot day before, and was nauseated morning after shot but was tollerable. About 1 pm was sitting at my desk when felt flush and neck hurt. Noted rash across neck and upper torso, swelling at lymph node L side neck area. Area was painful to light touch. Pt (self) went to urgent care to be further evaluated by someone else other than patient, once there began to get worse. All over tingling but significant at fingers, toes and mouth lips. Unable to talk clearly, but never became confused. So tired unable to stay awake; difficult to rouse. No difficulty with breathing; Epi was not needed or given. Transported to hospital via EMS due to inability to stay awake and difficulty speaking/unable to stand without assistance. It was very hard to talk - to get the words out - but I never did have any decline in mental thought process and was never disorientated. Looked intoxicated however. At hospital when pt transferred from stretcher to bed, pt doubled over due to abdominal discomfort - it was where the EKG stickers were. All reflexes noted to be hyper - MD kicked on accident when checking reflexes. the EKG stickers felt like being punched or slapped. Needed assistance transferring. All over numbness/tingling noted. Breathing never affected. Symptoms resolved after a few hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,SCH,none,none,"asthma, angina, rhynards syndrome",,"penicillins, avalox, percidan (aspirin)","['Blood glucose normal', 'Blood potassium decreased', 'Blood test normal', 'Dysarthria', 'Fatigue', 'Flushing', 'Headache', 'Lymphadenopathy', 'Nausea', 'Neck pain', 'Paraesthesia', 'Rash', 'SARS-CoV-2 test negative', 'Tenderness', 'Toxicologic test normal']",1,MODERNA,IM 927351,FL,22.0,F,"Indigestion, constipation Very sore arm radiating from site of injection starting 5 hours after injection and lasting for about 24 hours following injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,UNK,"Prozac, 40mg Fluticasone Zyrtec Birth control",,Depression,,"Pollen, omnicef","['Constipation', 'Dyspepsia', 'Injection site pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 927352,OH,39.0,F,"I had my vaccine on 12/30/2020 and in 01/07/2021 I had redness, swelling and a rash at the injection site. I also had pain and my arm felt warm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,"Percocet, tramadol, baclafin",Was tested for Covid after having mild symptoms for two weeks after exposure to covid positive family member,"Factor V Leiden, degenerative disc disease of spine,",,No,"['Injection site erythema', 'Injection site rash', 'Injection site swelling', 'Pain in extremity', 'Skin warm']",UNK,MODERNA, 927353,OR,58.0,F,"01/07/21 @ 03:00 A.M> Woke with Severe Headache too soon to take medications Nausea @ 04:55 A.M. took Ondancatron 8 mg, Promethazine 25 mg, Hydrocodone 1/2 - 10-325, Tylenol 500 mg, and Benedryl 25 mg. 11:00 A.M. Hands/Ankles and Feet swollen - Rings were very tight on my fingers. 02:00 P.M Walked to work 1/4 mile - and was sent home again 1/4 mile - upon reaching home I was short of breath - NOT Normal for me. Severe Headache all day, but nausea has subsided. Some itching of injection site earlier in day, now just sore if touched.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,"Hydrocodone - 1/2 of 10-325 mg , Tylenol 650 mg, Cyclobenziprine 10 mg, Loratadine 10 mg - All the prior taken at 01:55 PM 01/06/21",None,Migraines and Lower Back C4 /C5 Pain,,"Medications: Insaids, most Antibiotics, and no food allergies known.","['Dyspnoea', 'Headache', 'Injection site pain', 'Injection site pruritus', 'Joint swelling', 'Nausea', 'Peripheral swelling', 'Skin tightness']",1,MODERNA,SYR 927354,GA,60.0,M,"Low grade fever, malaise, headache, mild body aches, sort of out of it at times. Stated feeling bad within 2hrs of shot. Tx-rest, lots of sleep, Tamiflu. Felt bad for 2days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"Valsartan, hctz, fentanyl patch, hydrocodone, amlodipine",None,Hypertension. Chronic pain,,Shellfish,"['Altered state of consciousness', 'Feeling abnormal', 'Headache', 'Malaise', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 927355,WA,60.0,F,"12 hours post injection 7:30p, low grade fever 99F, queasy, brain fog and exhaustion. Fever went away over night, the rest of the symptoms stayed through the day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Losartan 100mg, Metoprolol succinate 25mg",,"High Blood pressure, anxiety","10/2020 Flu vaccine, similar event as with the Pfizer Covid vaccine","Sensitive to Sulfa, Opiates","['Fatigue', 'Feeling abnormal', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,IM 927356,AR,39.0,F,"On day 2, red are below the injection site. Faded away after a couple days. Day 9, itchy rash at the same site below the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,PHM,"Zoloft, multivitamin",,,,Sulfa,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 927945,RI,61.0,M,"Next day. 12/31/20 - severe muscle pain myalgia, could not ambulate well 1/1/21 - chills severe shaking chills N/V & diarrhea severe shivering, freezing causing difficulty breathing lasted 1/2 hour",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,UNK,Lisinopril verapamil prednisone,,HTN,,Avelox,"['Chills', 'Diarrhoea', 'Dyspnoea', 'Feeling cold', 'Gait inability', 'Myalgia', 'Nausea', 'Tremor', 'Vomiting']",1,MODERNA,IM 927947,MI,85.0,M,Noted left arm soreness without swelling or redness. Shoulder was sorer the next day. Upon arising noted BL facial swelling/tightness similar to past reaction with lisinopril. 0 lip/tongue swelling. Swallow and breathing is normal.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,,,PVT,,,,,,"['Arthralgia', 'Pain in extremity', 'Swelling face']",1,MODERNA,IM 927954,ME,36.0,F,"Dose administered on 12/28/2020. Patient experienced slight pain at injection site and symptoms resolved by next day. On 1/5/2021 patient experienced large, hot, circular rash about the size of a baseball at the injection site. Patient also experienced numbness of left arm,left face and tongue. She also had a headache and mild diarrhea. She was advised to seek care at the emergency room. She was seen at the ED. The incident was determined to be an allergic reaction and was given diphenhydramine 50mg IV and famotidine 20mg IV as well as ondansetron 4mg. Patient was discharged to home with instructions to take diphenhydramine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,PVT,"Escitalopram, Clonazepam, Hydroxyzine, fluticasone, Lamotrigine, Levothyroxine, montelukast, omeprazole, ondansetron",None,"GAD, GERD, Hypothyroidism",,Fluvoxamine,"['Blood magnesium', 'Diarrhoea', 'Electrocardiogram', 'Full blood count', 'Headache', 'Hypersensitivity', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Injection site pain', 'Injection site rash', 'Injection site warmth', 'Metabolic function test', 'SARS-CoV-2 test', 'Urine analysis']",1,MODERNA,IM 927955,MD,53.0,F,Rash started on 1/5/21 at injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,PUB,None,,"hypothyroidism, hyperlipidemia",,,['Injection site rash'],1,MODERNA,IM 927956,FL,61.0,F,"States about 3 hours after receiving Moderna vaccine experienced headache, nausea, chills. The symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Vitamin D, Calcium, Estrogen, Crestor",None,"increased cholesterol, post menopausal osteopenia",,NKDA,"['Chills', 'Headache', 'Nausea']",1,MODERNA,IM 927957,IA,72.0,F,Started the afternoon of 12/30/2020 a headache then by evening I started to have an upset stomach. Next day this continued only more severe plus I had chills and fever. Then I started to have dry heaves and all symptoms continued for 4 days. Also was light headed and arm soreness but that was least of my worries.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Lisinopril, levothyroxine, citalopram, rovastatin prilosec",None,None,,"PCN, Biacin, Indocin, sulfa, tetracycline, ceftin, sular","['Abdominal discomfort', 'Chills', 'Dizziness', 'Headache', 'Pain in extremity', 'Pyrexia', 'Retching']",1,MODERNA,IM 927977,NY,56.0,F,She developed a red are on her left deltoid region last evening .The redness is about the size of a half dollar .The surrounding area on her deltoid is warm to the touch .Denies any itching or pain at the site. .She was seen by NP no treatment needed at this point .Her vaccine was done on 12/29/2020.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,WRK,"magnesium, loratadine, omega 3",none,none,,penicillin,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,IM 927994,NY,35.0,F,"Vaccination at 0639 0650 erythematous rash across neck & upper chest - observation extended to 30 min denied: SOB, lightheadedness throat tightness or scratchiness 0655 25mg Benadryl liquid given VS BP 130/90 HR 100, O2 Sat 100% 0705 VS BP 130/92 HR 88 O2 Sat 100% 710 returned to work feeling well",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,WRK,"citalopram, propanolol",None,None,,PCN | sulfa | Bananas,"['Rash', 'Rash erythematous']",2,PFIZER\BIONTECH,IM 928002,NY,50.0,F,"Pt states initial mild erythema at site after injection - resolved 1-2 days 1/5/21 8 days later noted erythema, swelling pain warmth at site. 10 cm x 10 cm advised to use topical ice, take 25mg oral Benadryl. 1/6/21 swelling resolved erythema spreading - referred to PCP",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,01/03/2021,8.0,WRK,none,none,none,,sulfa kiwi fiorcet banana,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 928009,NY,55.0,F,"Covid vaccination @ 1306, 30 min observation 1333 noted flush over neck & upper chest VS BP 138/82 HR 75 O2 Sat 98% 0 SOB, throat swelling, cough, lightheaded nausea observation extended to 30 min 1335 25 mg liquid Benadryl given 1352 VS BP 124/80 HR 84 O2 Sat 100% Returned to work feeling well",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,"Progesterone cream, vitamins",,left vocal cord paralysis,,ASA Betadine Latex,"['Cough', 'Dizziness', 'Flushing', 'Nausea', 'Pharyngeal swelling']",1,MODERNA,IM 928015,NY,49.0,F,"-vaccinated @ 1450 , at 1455 nausea VS BP 132/84 HR 90 O2 Sat 99% 1500 SOB, wheezing, lightheadedness throat scratchy, pale VS BP 164/84 - observation ended - transported to ED by Emergency Team received 0.3mg epinephrine IM 50mg Benadryl IM , albuterol nebulizer x 1 Discharged from ED @ 1715",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,ProAir Allegra Vit D Albuterol Singular MVI,asthma,asthma migraines,,PCN Sulfa Strawberries ASA Macrolides Solumedrol,"['Dizziness', 'Dyspnoea', 'Nausea', 'Pallor', 'Throat irritation', 'Wheezing']",1,MODERNA,IM 928021,NY,58.0,F,"Vaccination at 1039 1057 reported itchiness at site. 1059 10mg Claritin oral given 1111 itchiness resolved denied: SOB, throat tightness, scraty observation extended to 30 min returned to work feeling well",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,"Synthroid, Vitamin D",None,Hypothyroidism,,None,"['Dyspnoea', 'Injection site pruritus', 'Throat irritation', 'Throat tightness']",1,MODERNA,IM 928037,MS,31.0,F,"Patient received the Moderna vaccine at County Hospital on 01/05/2021 at approx. 12 noon. She continue her work as normal throughout the day. She began having symptoms around 1700 the same day which consisted of left side facial decrease in sensation that continued to progress until the following day when it plateau'd. She was seen in the office on 01/06/2021 for continue decreased sensation of the left side of face and left eye pain. Patient had no other symptoms to mention. After assessment, the patient was diagnosed with a very mild case of Bell's Palsy. She was started on a high tapered dose of Prednisone over the next 2 1/2 weeks.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Adderall, Doxycycline, Wellbutrin",None,"Depression, ADHD",,NKDA,"['Eye pain', 'Facial paralysis', 'Paraesthesia']",1,MODERNA,IM 928065,NY,59.0,F,"Within 1 hr - slightly swelled/itchy nose => resolved within few hrs Within 3 hrs - the sensation of swollen lips (not visible), Zyrtec 10 mg BID started => almost resolved in 72 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Ca w/ vot D,,,,FiSH,"['Lip swelling', 'Nasal oedema', 'Pruritus']",UNK,MODERNA,IM 928435,FL,70.0,M,"Arm soreness, next day - body achiness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,"atorvastatin (20mg), Vitamin D (6000mg)",none,Sleep apnea (OSA),,none,"['Pain', 'Pain in extremity']",1,MODERNA,IM 928487,TX,27.0,F,"Vaccine given on (L) arm deltoid @ 3:35pm Client reported at 3:40 that her body is shaking, rapid heartbeat, dizziness at 3:40. Denied any shortness of breath or chills. BP 128/44 pulse 78 Respiration 18. Symptoms lasted 5 minutes, later at 3:55 Client stated her throat had felt strange but that she no longer felt it. Client Remain in clinic for observation for 45 minutes. Client Denied any further symptoms. Stating feels fine. 01/07/21 Phone call spoke with client she states the symptom Never returned and feels fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,,None per client,None per client,,,"['Dizziness', 'Heart rate increased', 'Oropharyngeal discomfort', 'Tremor']",1,MODERNA, 928503,NY,52.0,F,"Employee returned to vaccine clinic 3 hours post vaccine with red rash on face and neck, and very mild throat discomfort. Evaluation by Dr. and treated with Benadryl 25mg po and Pepcid 40mg oral. Symptoms resolved after medications.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"MVI. Vit. D3 ,Losartan, Pantoprazole, Premarin",12/22/2020 viral symptoms. Negative COVID test,none,,"Naproxen, Latex (rash) ,Oxycodone, Acetaminophen","['Oropharyngeal discomfort', 'Rash', 'Rash erythematous']",1,MODERNA,IM 928515,OK,74.0,M,"Previously well controlled non-insulin dependent type 2 diabetic (A1c 6.9 on 12/10/2020) developed polydipsia, polyuria, extreme fatigue, feeling off balance to point he does not feel comfortable driving (son drove him to appt). CBGs 330s-530s since. Less than 1 mo ago when here for DM his CBGs were 115-130s. No other medication, dietary changes, or illness to account for the abrupt change. Also reports he had vision loss on drive home following the vaccine administration. Vision loss resolved spontaneously after approx. 30 min. Presented to clinic for evaluation 01/05/21 for above listed symptoms. Concern for possible HHS/DKA so was sent to ER. Labs ruled out DKA/HHS, was given IVF and insulin, discharged home to to follow up in next few days.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/03/2021,4.0,OTH,"amlodipine, Victoza, atorvastatin, gabapentin, losartan, metformin, omeprazole",none,"hypertension, type 2 diabetes, diabetic neuropathy, gerd, hyperlipidemia, BPH, tobacco use",,myrbetriq (dizziness),"['Anion gap decreased', 'Balance disorder', 'Blindness transient', 'Blood chloride decreased', 'Blood creatinine increased', 'Blood glucose increased', 'Blood ketone body', 'Blood sodium decreased', 'Chest X-ray normal', 'Fatigue', 'Full blood count normal', 'Glucose urine present', 'Impaired driving ability', 'Insulin therapy', 'International normalised ratio normal', 'Nitrite urine absent', 'Polydipsia', 'Polyuria', 'Protein urine present', 'Prothrombin time normal', 'Specific gravity urine increased', 'Troponin increased', 'Urine leukocyte esterase positive']",1,PFIZER\BIONTECH,SYR 928549,PR,42.0,F,"patient states started with symptoms of facial paralysis on 12/24/2020 Patient states pain on left side of face and cephalic region on 12/25/2020 and went to ER, where was diagnosed with Facial Paralisis",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,01/04/2021,18.0,PUB,,,HTN,,,['Facial paralysis'],UNK,PFIZER\BIONTECH,IM 928713,,54.0,F,SkinRash Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/30/2020,3.0,OTH,,,,,,['Rash'],1,MODERNA,IM 928739,MS,50.0,F,"Patient was waiting in 15 minute waiting area after recieving vaccine. Patient called for nurse. Patient informed RN that she felt like her throat was closing up. Patient had her own personal pulse oximeter with a reading of 84%. Patient had redness at site of injection Epinephrine 1mg administered IM in (L) ventrogluteal Diphenhydramine 50mg administered IM in (L) ventrogluteal, O2 started on patient by paramedics on site. IV attempted in (L) ac without success. IV started in (R) ac with NS 0.9% Ambulance arrived at approximately 1450",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PUB,"Synthroid, Wellbutrin, HCTZ, Ambien",none,"hypothyroidism, depression",,"PCN, Sulfa","['Injection site erythema', 'Oropharyngeal discomfort']",1,MODERNA,IM 928807,OH,33.0,F,"Patient complains of tachycardia at rest, palpitations, SOB, chest tightness. Patients BP elevated above her normal BP. HR 118-136 for over an hour at rest. 25mg Benadryl given IM and patient advised to rest, monitor HR/BP. If chest pressure, SOB increase, refer to ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PUB,Nuvaning-vaginal,none,none,,None,"['Blood pressure increased', 'Chest discomfort', 'Dyspnoea', 'Palpitations', 'Tachycardia']",1,MODERNA,IM 928832,CO,52.0,M,"Date and time of vaccination: 12/17/21 19:30 Age at vaccination 52Y 10M Adverse symptoms: - Visual migraines 12/19,12/20,12/21 with loss of vision/aura for about 30m-1h, mild headache followed. -numbness, intermittent in left ring and pinky finger 12/19,12/20,12/21",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/19/2020,2.0,PVT,,,,,,"['Blindness transient', 'Headache', 'Hypoaesthesia', 'Retinal migraine']",1,PFIZER\BIONTECH,IM 928857,TX,47.0,F,"Blister to Lip 2 days after COVID Vaccine. C/W herpes labialis also (R) sided chest pain, mild, unclear causality. Also induration & swelling (L) injection site. NO skin redness (-) axillary temperature. TxT with acyclovir.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,WRK,"Botox, Ajovy, Nuvaring, multivitamin, tylenol",Migraines,Migraines,,"Keflex, Levoquin","['Chest pain', 'Injection site induration', 'Injection site swelling', 'Lip blister', 'Oral herpes']",1,MODERNA,IM 928889,AZ,37.0,F,"Patient reported that on 1/7/2021 she began to experience symptoms of feeling flushed, warm and nauseous. Shortly after she began to develop hives to her chest, arms, face and thighs and felt itchy. She then took a 25mg Benadryl tablet. She denied experiencing any difficulty swallowing, facial /throat swelling or difficulty breathing during this episode. Symptoms began to improve after taking oral Benadryl 25mg. Patient then contacte her tele-health doctor and was prescribed the following medications: Allegra, Medrol dose pack and Famotidine. Pt reports that she had not yet started these additional medications but notes improvement in her initial reported symptoms at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/07/2020,,PVT,Zyrtec otc,none,environmental allergies,,Keflex-hives,"['Feeling hot', 'Flushing', 'Nausea', 'Pruritus', 'Urticaria']",1,MODERNA,IM 928902,NY,23.0,M,"Complain of slight headache on the scale of 1/10 post vaccination - pt sateted he didn't eat lunch, electrolytes and nutrition given, vital signs BP 122/82 P 82 R 15, T 98.2 O2 sat 99% RA. Pt said problem resolved after prolonged monitoring",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Fluconazole, Antifungal pill, Echinacea",Rt great toe fungal infection,None,,NKDA,['Headache'],1,MODERNA,IM 928952,NY,59.0,F,"tongue swells, some swelli in Throat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2020,,,UNK,DiovaN,,Ulcerative colitis,,Spices,"['Pharyngeal swelling', 'Swollen tongue']",UNK,MODERNA, 928995,HI,60.0,F,"5 mins after Covid vax given, pt reported vertigo. Hx of vertigo. Ate breakfast, but few hours before. Reclined seat, gave water & snack BP: 116/70 After 10 mins (11:20am) felt better - released.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,unknown,none,"unknown, except hx of vertigo",,no,['Vertigo'],1,MODERNA,IM 929255,,48.0,F,"Headache, Myalgia, Arthralgia, chills, dry mouth, fatigue Narrative: Pt experienced arthralgia, chills, dry mouth, fatigue, headache, myalgia on same day after given covid vaccine. Pt treated with acetaminophen 650mg oral.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Dry mouth', 'Fatigue', 'Headache', 'Myalgia']",1,MODERNA,IM 929264,,52.0,F,"Headache, Myalgia, Arthralgia, chills, warm flushes, light sensitivity Narrative: Pt experienced arthralgia, chills, warm flushes, headache, light sensitivity myalgia on same day after received covid vaccine. Pt treated with Tylenol PM 650 mg PO, Nyquil cold an flu caps PO",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Hot flush', 'Myalgia', 'Photophobia']",1,MODERNA,IM 929270,,65.0,M,"Headache, Fever, Rash, malaise, aches Narrative: Pt reported itchy rash, malaise, aches, headache, fever on same day after given covid vaccine. Pt did not take any treatment medications.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/05/2021,4.0,OTH,,,,,,"['Headache', 'Malaise', 'Pain', 'Pyrexia', 'Rash pruritic']",1,MODERNA,IM 929275,,47.0,F,"Headache, Myalgia, Fever, arm soreness, chills Narrative: Pt experienced arm soreness, chills, fever, headache, mayalgia on day after covid vaccine admin. Pt self treated with acetaminophen 650mg oral.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 929286,,53.0,F,"Headache, Arthralgia, low back pain, arm pain, brain fog Narrative: Pt reported low back pain, arthragia, headache, arm, brain fog on day after given covid vaccine. Pt self treated with ibuprofen 400mg.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Arthralgia', 'Back pain', 'Feeling abnormal', 'Headache', 'Pain in extremity']",1,MODERNA,IM 929293,,61.0,F,"Myalgia, Fever, chills, fatigue, painful red arm Narrative: Pt experienced chills, fever, fatigue, myalgia, painful red arm on day of vaccination administration. Pt did not treat symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Erythema', 'Fatigue', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 929295,,57.0,F,Myalgia Abdominal pain Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/03/2021,11.0,OTH,,,,,,"['Abdominal pain', 'Myalgia']",1,MODERNA,IM 929297,,31.0,F,"SkinRash Rash was on knees, thighs & pelvis Narrative: Pt experienced as rash on thighs, knees and pelvis on same day vaccine received. Treated with topical Benadryl cream and topical hydrocortisone cream.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Rash'],1,MODERNA,IM 929303,,49.0,F,Headache & NauseaVomiting Narrative: Pt experienced nausea and headache on day of vaccine administration relieved with ibuprofen 400mg oral,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 929306,,35.0,F,Myalgia chills Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Myalgia']",UNK,MODERNA, 929311,,47.0,F,Headache Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,['Headache'],1,MODERNA,IM 929314,,66.0,M,Tinnitus Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,OTH,,,,,,['Tinnitus'],1,MODERNA,IM 929344,,64.0,F,"Headache, Myalgia, pain at injection site Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Injection site pain', 'Myalgia']",1,MODERNA,IM 929351,,60.0,F,"Myalgia, Arthralgia, Fever, Local adenopathy, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Lymphadenopathy', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 929355,,35.0,M,"Dizziness, RespDepression, passed out Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Dizziness', 'Loss of consciousness', 'Respiratory depression']",1,PFIZER\BIONTECH,IM 931853,,50.0,M,"Patient received Pfizer Covid 19 vaccine at 1400. He felt fine initially. At 1600 developed lightheadedness, slight headache and intermittent tingling to his left fingers. He reports itching to his extremities. He has not noticed a rash. He denies syncope, nausea, vomiting, sore throat, congestion, chest pain, SOB, palpitations, weakness, slurred speech, abdominal pain, diarrhea. He denies history of prior allergic reactions. No new medications. he is not anxious. Denies rash likely related to vaccine administration at 1400; seen in the urgent care at 1600 and discharged after treatment and evaluation at 1858. Inventions: ekg no acute findings; methylPrednisonolone 125 mg IV; diphenhydramine 25 mg IV; famotidine 20mg po; odansetron 4mg IV home with Benadryl 25 mg Q6 hours for 5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,,,,,UNK,,,Healthy/No known comorbidities,,,"['Dizziness', 'Electrocardiogram normal', 'Headache', 'Paraesthesia', 'Product administered at inappropriate site', 'Pruritus']",UNK,PFIZER\BIONTECH,SC 932397,,54.0,M,"Headache, Myalgia, Fever, CoughWheeze & Diarrhea Narrative: Took acetominophen. Symptoms improving past 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Cough', 'Diarrhoea', 'Headache', 'Myalgia', 'Pyrexia', 'Wheezing']",1,MODERNA,IM 932398,,64.0,M,Myalgia Numbness in injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Injection site hypoaesthesia', 'Myalgia']",1,PFIZER\BIONTECH,IM 932400,,47.0,F,"Dizziness, UrticariaPruritus, HYPERtension, facial flushing, face felt warm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Dizziness', 'Feeling hot', 'Flushing', 'Hypertension', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 933411,,34.0,F,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 933413,,36.0,F,"Myalgia, Fever, Chills and low-grade temp.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 933420,,62.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 933425,,38.0,F,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia']",UNK,MODERNA, 933428,,37.0,F,"Headache, Myalgia, Arthralgia, lightheaded",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Arthralgia', 'Dizziness', 'Headache', 'Myalgia']",1,MODERNA,IM 933429,,32.0,M,"Headache, Myalgia, CoughWheeze, Diarrhea, congestion, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/21/2020,3.0,OTH,,,,,,"['Cough', 'Diarrhoea', 'Fatigue', 'Headache', 'Myalgia', 'Sinus congestion', 'Wheezing']",1,PFIZER\BIONTECH,IM 933431,,49.0,M,Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,['Pyrexia'],1,MODERNA, 933437,,62.0,M,"Myalgia, Fever, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 933440,,31.0,M,"Myalgia, Fever, Diarrhea, GI upset and arm pain (started 12/29), all other symptoms including chills started this morning, flushed",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Abdominal discomfort', 'Chills', 'Diarrhoea', 'Flushing', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,MODERNA, 933442,,53.0,F,"Headache Weakness, Myalgia, Arthralgia, Weakness, Nausea, Palpitations Narrative: Medication and self-care instructions: drink plenty of fluids, take motrin if needed.please return if symptoms worsen or persist.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/23/2020,2.0,OTH,,,,,,"['Arthralgia', 'Asthenia', 'Headache', 'Myalgia', 'Nausea', 'Palpitations']",1,PFIZER\BIONTECH,SC 933446,,67.0,F,"Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/23/2020,,OTH,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA, 933454,,43.0,M,"Headache, Myalgia, Fever, Fatigue, Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA, 933459,,42.0,F,"Dizziness, Headache, Myalgia, Fever, CoughWheeze,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/19/2020,2.0,OTH,,,,,,"['Cough', 'Dizziness', 'Headache', 'Myalgia', 'Pyrexia', 'Wheezing']",1,PFIZER\BIONTECH,IM 933462,,30.0,F,Fever & Diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Pyrexia']",1,MODERNA,IM 933468,,44.0,F,Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Pyrexia'],1,PFIZER\BIONTECH,IM 933470,,47.0,F,"Headache & Fever Narrative: Contacted Employee Occupational Health to report symptoms, already starting to improve after 24 hours post-vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Pyrexia']",1,MODERNA,IM 933475,,60.0,M,"Headache, Myalgia, Fever & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 933502,,63.0,F,influenza like symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,['Influenza like illness'],1,MODERNA,IM 933507,,53.0,M,"Myalgia, NauseaVomiting Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Fatigue', 'Myalgia', 'Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 933508,,67.0,M,"Patient was ""just off COVID Isolation on 12/24/(20)"" Worked entire day post injection. Noticed discomfort when arrived home at 1600 hours. ""Stomach was bothering me"". Patient h/o ""chronic stomach pain, I had hernia surgery in 2018"". Describes discomfort as ""sharp pain"" an 8/10 on 10 Pain Scale. Pointed to entire abd area when asked location of pain. At 1600 hours, ""took some Tylenols, 2 Tylenols, with water, laid down don't remember if I slept, wife got home at 8:30(pm), got up ant ate"". Patient post dinner noticed right arm discomfort, sharp 8/10 on a 10 Pain Scale, pain radiated past elbow to mid-forearm. Abd pain had alleviated, but RUE Discomfort continues. ""I laid back down for the night."" States in past, when received other immunizations does not have arm pain. States next morning after injection, ""could barely move my arm, I took a shower, let the warm water comfort it, but couldn't lift arm high, pain continued'. In addition to RUE and abd discomfort, had c/o HA. Denies h/o Headaches. Patient HA onset was immediately prior to dinner on 12/28/20 7/10 on 10 Pain Scale describes HA as ""pressure"" in (B) orbitals and forehead. HA continues, 12/29/20 morning, HA pain level was 6-7 / 10. Did not take any pain relief medications, only took his prescription medications. Denies any trauma to head, abd or RUE. Active Problems from Agency pertaining to his visit: Incisional hernia K43.2 05/29/2018 Asthma J45.30 11/22/2016 Type 2 diabetes mellitus E11.9 11/11/2015 Hepatitis C K73.2 11/11/2015 Chronic pain G89.21 11/04/2015 Sciatica M54.31 10/21/2015 Pain Disorder associated with Psych 01/06/2015 Occupational maladjustment V62.29 11/12/2014 Asthma attack (SONMED CT 708038006) 06/12/2016 : 98.7F oral, HR 83 bpm, RR 16, B/P 133/86, SaO2 on RA 94%. Unable to lift right arm past wrist (20 degrees). As compared to LUE, the RUE is very tender to touch, unable to measure completely, but there appears to be a raised, non-draining area approximately ten (10) cm in diameter. No erythema. No additional warmth. Patient discomfort from injection site (band-aid was still on arm) radiating past elbow to mid-forearm. Appears to be in discomfort as removes shirt for inspection with slow guarded movements. Facial grimaces and verbal complaints of pain present also as removed shirt. Had not had normal BM this morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Abdominal discomfort', 'Abdominal pain', 'Head discomfort', 'Headache', 'Injected limb mobility decreased', 'Injection site discomfort', 'Injection site swelling', 'Limb discomfort', 'Pain', 'Pain in extremity', 'Tenderness']",1,MODERNA,IM 933509,,54.0,M,"Dizziness, Headache, Myalgia, stomach ache, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,OTH,,,,,,"['Abdominal pain upper', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia']",1,MODERNA,IM 933510,,47.0,F,"Myalgia, Arthralgia, Fever, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 933511,,52.0,M,"Myalgia, Arthralgia, Fever & NauseaVomiting Pt self reported fever, myalgia, arthralgia, nausea. Pt self treated with ibuprofen 200mg.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Arthralgia', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 933512,,57.0,F,"Myalgia, Fever, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 933513,,42.0,F,SkinRash,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/25/2020,01/02/2021,8.0,OTH,,,,,,['Rash'],1,MODERNA,IM 933514,,53.0,F,Fever malaise,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Malaise', 'Pyrexia']",1,MODERNA,IM 933515,,62.0,F,CoughWheeze,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Cough', 'Wheezing']",1,PFIZER\BIONTECH,IM 933518,,,M,Rash,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/31/2020,9.0,OTH,,,,,,['Rash'],1,MODERNA,IM 933519,,53.0,F,ErythemaMultiform,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/24/2020,2.0,OTH,,,,,,['Erythema multiforme'],1,MODERNA,IM 933520,,31.0,F,Itchy and redness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,OTH,,,,,,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 933521,,65.0,F,"Headache, Diarrhea & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 933522,,42.0,F,"Rash & UrticariaPruritus telephone nurse visit. advised to ice site, take OTC apap PRN and OTC antihistamines for itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/01/2021,4.0,OTH,,,,,,"['Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 933523,,50.0,M,"Headache, Fever, fatigue, weakness, sore throat Narrative: 12/29 - received vaccine. 12/30 - woke up with a fever and scratchy throat and headache. Since then the symptoms have lingered. Jan 2- 3 he developed more fatigue. Jan 4 - fever to 101 and headache. He also feels weak and has intermittent scratchy throat. Also had injection site soreness. He has Rheumatoid Arthritis for which he's taking actimira, and methotrexate (immunesupressants). Will test him today (1/4) for COVID-19. 1/5 - COVID-19 test is negative. Employee reports resolution of all symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Asthenia', 'Fatigue', 'Headache', 'Injection site pain', 'Oropharyngeal pain', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 933524,,49.0,F,Rash swelling and heat at the injection site and now severe itching,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/01/2021,8.0,OTH,,,,,,"['Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site warmth']",1,MODERNA, 933525,,44.0,F,"Diarrhea Fatigue; Eye - Redness, swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Diarrhoea', 'Eye swelling', 'Fatigue', 'Ocular hyperaemia']",1,MODERNA, 933526,,46.0,F,SkinRash Dyspnea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/31/2020,9.0,OTH,,,,,,"['Dyspnoea', 'Rash']",1,MODERNA, 933527,,55.0,M,NauseaVomiting HA Narrative: went home for rest and fluids,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/04/2021,,OTH,,,,,,"['Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 933528,,55.0,F,Headache enlarged lymph gland,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Headache', 'Lymphadenopathy']",1,MODERNA,IM 933529,,54.0,F,"Headache, Myalgia, Diarrhea, NauseaVomiting, injection site soreness initially, then on the 30th arm was very sore, runny nose, shoulder/neck aches, severe N/V/D, severe fatigue Narrative: Did not need to seek medical care. Stayed at home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Pain', 'Pain in extremity', 'Rhinorrhoea', 'Vomiting']",1,PFIZER\BIONTECH,IM 933530,,28.0,M,Rash & Purpura,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Purpura', 'Rash']",1,MODERNA,IM 933531,,42.0,F,ErythemaMultiform,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,08/18/1979,12/24/2020,15104.0,OTH,,,,,,['Erythema multiforme'],1,MODERNA,IM 933532,,59.0,M,ErythemaMultiform,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,['Erythema multiforme'],1,MODERNA,IM 933533,,52.0,F,"Myalgia, CoughWheeze, UrticariaPruritus, NauseaVomiting, Syncope, itching; chest congestion; fatigue body ache; n/v for the first 24 hrs of vaccinating employee Narrative: 12/29 developed itching and chest congestion that flared up my asthma. 12/30 still itching and chest congestion/ having bad fatigue, body aches, nausea and diarrhea lasted for 24 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Asthma', 'Condition aggravated', 'Cough', 'Diarrhoea', 'Fatigue', 'Myalgia', 'Nausea', 'Pain', 'Pruritus', 'Respiratory tract congestion', 'Syncope', 'Urticaria', 'Vomiting', 'Wheezing']",1,MODERNA,IM 933538,,1.58,M,"Myalgia, CoughWheeze, chills, sore throat, fatigue Did not have to seek medical care, just waiting for symptoms to subside.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,OTH,,,,,,"['Chills', 'Cough', 'Fatigue', 'Myalgia', 'Oropharyngeal pain', 'Wheezing']",1,PFIZER\BIONTECH,IM 933544,,62.0,F,"Headache, Myalgia, Local arm myalgia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Headache', 'Local reaction', 'Myalgia']",1,MODERNA,IM 933550,,38.0,F,"Fever Congestion, Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Pyrexia', 'Respiratory tract congestion']",1,MODERNA, 933555,,60.0,F,NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Nausea', 'Vomiting']",1,MODERNA, 933558,,29.0,F,Metallic Taste,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Dysgeusia'],1,MODERNA, 933564,,50.0,F,"Headache Pain at the insertion site, right shoulder pain, and headache. Did not take any medication for reported symptoms. Narrative: Reports pain at the insertion site, right shoulder pain and headache starting 1/3. She reports has not taking any medication for reported symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,OTH,,,,,,"['Headache', 'Injection site pain']",1,MODERNA,ID 933569,,47.0,F,"Myalgia, Fever, Rash, malaise Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Malaise', 'Myalgia', 'Pyrexia', 'Rash']",1,MODERNA,IM 933575,,53.0,F,"Myalgia, Arthralgia, Fever, NauseaVomiting, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/29/2020,,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA, 933580,,40.0,F,swollen lymphnodes in left ear to arm area Narrative: employee went to PCP. They determined the employee had an ear infection and prescribed antibiotics,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Ear infection', 'Lymphadenopathy']",1,MODERNA,IM 933584,,35.0,F,"Dizziness, Myalgia, Fever & CoughWheeze Narrative: Employee reports having no s/s until the morning after her first dose. Reports fever 99.3, chills sore arm, dizziness , cough and body ache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Chills', 'Cough', 'Dizziness', 'Myalgia', 'Pain', 'Pain in extremity', 'Wheezing']",1,MODERNA,IM 933588,,31.0,M,Myalgia Chills,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,OTH,,,,,,"['Chills', 'Myalgia']",1,MODERNA, 933595,,66.0,F,BlurredVision,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,['Vision blurred'],1,MODERNA,IM 933600,,55.0,F,"Headache, Myalgia, Fever, CHILLS/ FATIGUE Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 933606,,42.0,F,"Agitation, Depression, Myalgia, sore right arm Narrative: Employee states, ""I did experience the sore arm, though mine lasted about a week. I received my vaccine the morning of the 21st and by the evening I was experiencing what I have been called ""tantrum moodiness"". Short fuse, unreasonably angry, felt like crying, yelling, arguing. By the next day some general malaise that led to aching, especially it seemed in connective tissue. More moodiness, crying, some yelling. By Wednesday it seemed to resolve.""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,"['Agitation', 'Anger', 'Crying', 'Depression', 'Malaise', 'Mood altered', 'Myalgia', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 933613,,48.0,F,"3""X1"" AREA OF PAIN, REDNESS, WARMTH, INDURATED ON 12/30/20 LASTING 48 HOURS; STATES HEADACHE FROM 12/29-12/31/20; REDNESS SUBSIDED BUT HAS RETURNED IN PAST 2 DAYS WITH PRUTITUS, REDNESS AT INJECTION SITE TO LEFT DELTOID.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Erythema', 'Headache', 'Induration', 'Injection site erythema', 'Injection site pruritus', 'Pain', 'Skin warm']",1,MODERNA,IM 933615,,32.0,F,PAIN IN THE LEFT ARM PIT REGION 2 DAYS AFTER,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/29/2020,5.0,OTH,,,,,,['Axillary pain'],1,MODERNA,IM 933619,,62.0,M,"Syncope Hx of syncopal episodes during any procedures, per ED note. Narrative: c/o of feeling flushed and pt. asked to lay down @11 am in the observation area. Staff able to get pt. to cart before she ""passed out."" She immediately responded but RRT was called to assess the patient. BP low, per RRT (84/54 P 53, 108 /65 P 51) and pt. was taken to the ED at 1112. No SOB, nausea noted. Per ED and final report was that the reaction was not an allergic reaction nor a side effect of the injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,OTH,,,,,,"['Flushing', 'Hypotension', 'Loss of consciousness']",1,PFIZER\BIONTECH,IM 933624,,31.0,M,"c/o shaking and was pale, per assessment. VSS. RRT assessed. Narrative: pt. noted to be shaking and had labored breathing when brought to Observation area after vaccination. RRT called and recommended additional 30 min. monitoring. 121/76, P 72, R 20, O2 sat. 98% Discharged in stable condition at 4:15PM.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,OTH,,,,,,"['Dyspnoea', 'Pallor', 'Tremor']",1,PFIZER\BIONTECH,IM 933742,,59.0,F,"NauseaVomiting dry mouth, sore R arm Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Dry mouth', 'Nausea', 'Pain in extremity', 'Vomiting']",1,MODERNA,IM 933743,,35.0,F,Fever exhaustion Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Fatigue', 'Pyrexia']",1,MODERNA,IM 933744,,33.0,F,"Headache, Fever, took temp at work 99.5-99.8 @ 0700. retook temp 100.3 @ 104.5. temp taken 1115 was 98.0 in EOH Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Headache', 'Pyrexia']",1,MODERNA,SC 933745,,26.0,F,"Large knot in arm that is hot, red and painful Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,OTH,,,,,,"['Erythema', 'Nodule', 'Pain in extremity', 'Skin warm']",1,MODERNA, 933746,,63.0,F,"Headache, NauseaVomiting, Sore throat,fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Nausea', 'Oropharyngeal pain', 'Vomiting']",1,PFIZER\BIONTECH,IM 933747,,56.0,F,"Myalgia 1/2/2021 REPORTS HANDS/LEGS MOTTLED AND COLD, EXTREME FATIGUE THAT LASTED UNTIL ABOUT NOON 1/4/2021; STILL WITH CHILLS, FATIGUE Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/02/2021,5.0,OTH,,,,,,"['Chills', 'Fatigue', 'Livedo reticularis', 'Myalgia', 'Peripheral coldness']",1,MODERNA,IM 933753,,46.0,F,SkinRash swollen and itchy at vaccination site. started 2 days later. Increasing swelling until Jan 5 and now improving Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/05/2020,,OTH,,,,,,"['Injection site pruritus', 'Vaccination site swelling']",1,MODERNA,IM 933760,,39.0,F,"pain, swelling, itching in injection site Narrative: With PMD appt. 1/4/21 at 5PM. was advised to take meds.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,01/02/2021,11.0,OTH,,,,,,"['Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 933769,,54.0,F,"Myalgia, Fever, Chills, loss of taste/smell Narrative: tested COVID positive in 1/4/21 from household exposure she learned about after she had the immunization",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Ageusia', 'Anosmia', 'COVID-19', 'Chills', 'Exposure to SARS-CoV-2', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA, 934447,,61.0,M,Myalgia Chills fatigue body ache; sore arm day 2,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Myalgia', 'Pain', 'Pain in extremity']",1,MODERNA,IM 934453,,38.0,F,"PAIN TO LEFT AXILLARY AREA, SWELLING AND INDURATION TO INJECTION SITE STARTED 12/24/20, 12/31/20 REDDENED AREA ~4IN IN DIAMETER AT INJECTION SITE THAT LASTED A FEW DAYS; REPORTS THOSE SYMPTOMS RESOLVED NOW; HOWEVER, HAS CLEAR FLUID FILLED VESICULAR RASH T",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Axillary pain', 'Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Rash vesicular']",1,MODERNA,IM 934458,,53.0,F,Angioedema Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Angioedema'],1,MODERNA,IM 934463,,54.0,F,"Headache ""L side face/ear full-as day progressed it went away. h/a worsened overnight"". Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Ear discomfort', 'Headache']",1,MODERNA,IM 934464,,58.0,M,"Dizziness, Headache, malaise, pain and limited ROM in injected arm Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Dizziness', 'Headache', 'Injected limb mobility decreased', 'Malaise', 'Pain in extremity']",1,MODERNA,IM 934468,,67.0,M,"Dizziness, Headache, Bilat LE edema, runny nose, periods of disorientation w/in 24 hours Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Disorientation', 'Dizziness', 'Headache', 'Oedema peripheral', 'Rhinorrhoea']",1,MODERNA,IM 934518,,34.0,F,Myalgia & Arthralgia,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,OTH,,,,,,"['Arthralgia', 'Myalgia']",UNK,PFIZER\BIONTECH,IM 934528,,48.0,F,"UrticariaPruritus Started with urticaria/pruritus around 3rd day, then redness, swelling, induration, itching started 1/2/201, resolved to redness 1/5/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/26/2020,3.0,OTH,,,,,,"['Erythema', 'Induration', 'Pruritus', 'Swelling', 'Urticaria']",1,MODERNA,IM 934532,,42.0,F,"Dizziness, Myalgia, SORE ARM DAY 2 AND 3; DIZZY/ FATIGUE-DAY 5-7 UPTO DAY 14 SORE ARM DAY 2 AND 3; DIZZY/FATIGUE- DAY 5-7 UPTO DAY 14",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Dizziness', 'Fatigue', 'Myalgia', 'Pain in extremity']",1,MODERNA,IM 934537,,56.0,F,"Dizziness, NauseaVomiting, R arm pain, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,OTH,,,,,,"['Dizziness', 'Fatigue', 'Nausea', 'Pain in extremity', 'Vomiting']",1,MODERNA,IM 934551,,52.0,F,Headache & Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 934556,,52.0,M,"Headache, Myalgia, Fever, Diarrhea, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Diarrhoea', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 934561,,56.0,M,"Redness, swelling, warmth, itching around the injection site lasting 48-72 hours, symptoms subsided then returned on 1/2/201; Employee advised use of oral or topical antihistamine .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 934566,,53.0,F,"Myalgia, Fever, Sore arm; ringing in ear Narrative: Day Two: Soreness around injection site, body aches, low grade fever, fatigue Day three: Soreness around injection site, Body aches, fatigue Day four: Fatigue Day five: Periodic ringing in right ear",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Fatigue', 'Injection site pain', 'Myalgia', 'Pain', 'Pain in extremity', 'Pyrexia', 'Tinnitus']",1,MODERNA,IM 934571,,34.0,F,"Myalgia, Arthralgia, local site reaction and fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Injection site reaction', 'Local reaction', 'Myalgia']",UNK,MODERNA, 934572,,34.0,F,"Headache, Myalgia, Fever, (Temperature 100.8) Narrative: Chills, aches, fatigue, headache, temperature 100.8 for 2 days. (Missed 2 days of work, plans to return to work tomorrow.)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pain', 'Pyrexia']",1,MODERNA,IM 934586,,61.0,F,mild itching and swelling around the injection site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/03/2021,6.0,OTH,,,,,,"['Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 934626,,42.0,F,"Agitation, Dizziness, Sedation, NauseaVomiting, FELT HUNGOVER, FOGGY HEAD, HOT FLASHES, TIRED, ANXIOUS, NAUSEA",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,UNK,,,,,,"['Agitation', 'Anxiety', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Hot flush', 'Nausea', 'Sedation', 'Vomiting']",UNK,MODERNA, 934640,,45.0,F,"INJECTION SITE RED, WARM HARD Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/02/2021,2.0,OTH,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site warmth']",UNK,MODERNA, 934652,,57.0,F,Headache pain in injection site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Headache', 'Injection site pain']",1,MODERNA,IM 936859,,39.0,F,"Headache ""runny nose"" Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/02/2021,,OTH,,,,,,"['Headache', 'Rhinorrhoea']",1,MODERNA,IM 936860,,45.0,M,Left Upper Extremity Numbness Narrative: 15 minutes after vaccination developed Numbness and Tingling down his arm. Slowly resolving,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 936861,,46.0,F,"Headache, Myalgia, NauseaVomiting, HEADACHE, CHILLS, BODY ACHE, NAUSEA",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Vomiting']",UNK,MODERNA, 936862,,34.0,M,"Headache, Fever, pain in injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Headache', 'Injection site pain', 'Pyrexia']",1,MODERNA,IM 936863,,55.0,F,"Lymphadenitis Narrative: 2.5 days after injection, noted tenderness and swelling of lymph nodes in axilla of the arm where she received the shot. possible mild fatigue. denies fever, chills, other s/s of illness or other AEs other than localized tenderness in area of injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,OTH,,,,,,"['Chills', 'Injection site pain', 'Lymphadenitis', 'Lymphadenopathy', 'Pyrexia']",1,MODERNA,IM 936864,,49.0,F,"Headache, Myalgia, Arthralgia, Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Myalgia']",1,MODERNA,IM 936873,,30.0,F,"Dizziness, Headache, Tachypnea, soreness in arm, runny nose, severe fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Dizziness', 'Fatigue', 'Headache', 'Pain in extremity', 'Rhinorrhoea', 'Tachypnoea']",1,MODERNA,IM 936885,,53.0,F,"Dizziness, Headache, Arthralgia, fatigue, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Dizziness', 'Fatigue', 'Headache']",1,MODERNA,IM 936896,,29.0,M,"Myalgia, Diarrhea, ""chills"" no fever Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Diarrhoea', 'Myalgia']",1,MODERNA,IM 936907,,60.0,F,"Dizziness, Headache, Myalgia & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,yes shingles injection site pain/very hard size of baseball in 11/2019,,"['Dizziness', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 936916,,22.0,M,Headache arm where she recieved injection is sore. Narrative: Employee awoke with headache this morning at 0430. Employee has not taken any OTC meds for headache. Employee was instructed to take OTC acetaminophen/ibuprofen.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Headache', 'Injection site pain']",1,MODERNA,SC 936927,,31.0,F,"Dizziness, Headache, Myalgia, RespDepression, Palpitations, arm soreness and discoloration, chills Narrative",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Chills', 'Dizziness', 'Headache', 'Myalgia', 'Pain in extremity', 'Palpitations', 'Respiratory depression', 'Skin discolouration']",1,PFIZER\BIONTECH,IM 936937,,67.0,M,Rash Narrative: Rash on bilateral upper arms.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Rash'],UNK,MODERNA, 937003,,44.0,F,"Fever, Diarrhea, NauseaVomiting, pain and swelling at injection site Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Diarrhoea', 'Injection site pain', 'Injection site swelling', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 937011,,53.0,F,"Myalgia, Fever, CHILLS Narrative: CHILLS, FEVER, BODY ACHES LASTED UNTIL 1/1/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pain', 'Pyrexia']",UNK,MODERNA, 937017,,66.0,F,ErythemaMultiform Redness at injection site has increased and up to 8 cm. Has warmth at injection site..,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/05/2021,10.0,OTH,,,,"Yes reddness and swelling at injection site,16 years,tetanus vaccine",,"['Erythema multiforme', 'Injection site erythema', 'Injection site warmth']",1,MODERNA,IM 937018,,47.0,M,Myalgia & Fever Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Myalgia', 'Pyrexia']",1,MODERNA,IM 937019,,49.0,F,Dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 937020,,64.0,M,"CoughWheeze some mild congestion, scratchy throat post nasal drip Narrative: 12/29 Tested positive COVID",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/28/2020,5.0,OTH,,,,,,"['COVID-19', 'Cough', 'Respiratory tract congestion', 'SARS-CoV-2 test positive', 'Throat irritation', 'Upper-airway cough syndrome', 'Wheezing']",1,MODERNA,IM 937021,,34.0,F,"Headache, Myalgia, pain, swelling & swollen lymph nodes to injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/03/2021,5.0,OTH,,,,,,"['Headache', 'Injection site lymphadenopathy', 'Lymphadenopathy', 'Myalgia', 'Pain', 'Swelling']",1,MODERNA,IM 937022,,48.0,F,"NauseaVomiting, HYPERtension, facial reddness to the chest. Went to the ER Narrative: Reports having facial redness to the chest. Had severe nausea and hypertension. Went to the ER and discharged later that day. Still having nausea today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,"yes FLU VACCINE,18 YEARS",,"['Erythema', 'Hypertension', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 937023,,53.0,F,Myalgia & Fever Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Myalgia', 'Pyrexia']",1,MODERNA,IM 937024,,39.0,M,"Headache, NauseaVomiting, UPSET STOMACH Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Abdominal discomfort', 'Headache', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 937025,,65.0,F,"Dizziness restlessness, insomnia, lightheadedness, sore arm, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Dizziness', 'Insomnia', 'Pain', 'Pain in extremity', 'Restlessness']",UNK,MODERNA,IM 937026,,53.0,M,"Headache, Fever, lethargic,chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Headache', 'Lethargy', 'Pyrexia']",1,MODERNA,IM 937027,,41.0,F,"Headache, Arthralgia, arm pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/02/2021,2.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Pain in extremity']",1,MODERNA,IM 937028,,69.0,M,"NauseaVomiting cold chills, sweat, head congestion",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Feeling cold', 'Hyperhidrosis', 'Nasal congestion', 'Nausea', 'Vomiting']",1,MODERNA,IM 937029,,48.0,F,NauseaVomiting low back pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/12/2020,12/30/2020,18.0,OTH,,,,,,"['Back pain', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 937030,,58.0,M,"LEFT FACIAL AND TONGUE NUMBNESS - WORK UP CVA NEG Narrative: Developed left facial and tongue numbness 4 hours after vaccine - went to ER and admitted for 2 days, negative workup for CVA or other acute etiology. Symptoms resolved prior to discharge from hospital",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Laboratory test normal']",1,PFIZER\BIONTECH,IM 937031,,43.0,F,Reported face feeling warm. no other complaints. Refused to be taken to ED,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,['Feeling hot'],1,MODERNA, 937032,,51.0,M,Tingling to fingers which lasted for 10 min post injection Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,yes,,['Paraesthesia'],UNK,MODERNA, 937033,,52.0,F,Headache & Nausea Vomiting Narrative: Declined ED visit,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Headache', 'Nausea', 'Vomiting']",1,MODERNA, 937034,,39.0,M,"Confusion, Myalgia & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Confusional state', 'Myalgia', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 937036,,71.0,M,"SkinRash, Rash & ErythemaMultiform Narrative: employee reports skin rash at injection site erythema spreading to entire left upper arm. no itching or swelling. reports taking antihistamine (Claritin) q day, 1% hydrocortizone BID, and applying ice PRN. skin rash improving with treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/01/2021,9.0,OTH,,,,,,"['Erythema multiforme', 'Injection site erythema', 'Injection site rash', 'Rash']",1,MODERNA,IM 937037,,56.0,F,"Myalgia, Rash & UrticariaPruritus Narrative: Patient developed rash/blisters on the roof of her mouth, within two days this had crossed midline and onto the tongue. She saw her PCP who felt that with the fatigue and muscle aches this could be a reaction to the Moderna vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/01/2021,4.0,OTH,,,,,,"['Fatigue', 'Myalgia', 'Oral mucosal blistering', 'Oral mucosal eruption', 'Pruritus', 'Tongue blistering', 'Tongue eruption', 'Urticaria']",1,MODERNA,IM 937038,,34.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Headache'],1,PFIZER\BIONTECH,IM 937039,,50.0,M,"Headache, Myalgia, Fever & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Fear', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 937045,,28.0,M,"Headache Fatigue, chills Off work for 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Impaired work ability']",1,MODERNA,IM 937054,,61.0,M,"Headache, Myalgia, low grade temp, fascial redness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Erythema', 'Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 937057,,66.0,M,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,['Headache'],UNK,MODERNA,IM 937062,,37.0,F,NauseaVomiting Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Nausea', 'Vomiting']",UNK,MODERNA, 937069,,59.0,F,"Headache, Myalgia, Feeling feverish; woke up sweating",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Headache', 'Hyperhidrosis', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 937071,,34.0,F,Hives on arm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/29/2020,7.0,OTH,,,,,,['Urticaria'],UNK,MODERNA, 937077,,61.0,F,"Fever, Diarrhea, throat tightness, dyspepsia, injection site pain Narrative: Experienced throat tightness immediately after the vaccination. Observed by occupational health. Recovered with rest.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Dyspepsia', 'Immediate post-injection reaction', 'Injection site pain', 'Pyrexia', 'Throat tightness']",UNK,MODERNA,IM 937095,,38.0,F,NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Nausea', 'Vomiting']",1,MODERNA,IM 937107,,67.0,M,"Headache, Myalgia, sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pain in extremity']",UNK,MODERNA,IM 937115,,41.0,M,Myalgia & Arthralgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Arthralgia', 'Myalgia']",UNK,MODERNA, 937136,,33.0,F,"Rash post nasal drip with sore throat. reports woke morning after injection with localized tenderness and rash (red, blotchy non-raised, skin intact, no sloughing, no pustules, etc.) in area surrounding the injection site. She also reports post nasal drip with sore throat, which she often gets with flu shots. She reports rash was slightly larger today (measured 4.5 x 4.5 cm) so she came to clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Injection site pain', 'Injection site rash', 'Oropharyngeal pain', 'Rash erythematous', 'Rash macular', 'Upper-airway cough syndrome']",1,MODERNA,IM 937141,,57.0,F,"Headache, Fever, Body aches Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 937145,,49.0,F,"Fever body aches, pain in arm, flushing",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Flushing', 'Pain', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA,IM 937151,,38.0,F,"Agitation, Diarrhea, Tachycardia, Tingling in upper extremities, started having carpopedal spasms, Pale, anxious. Narrative: Patient brought over to the ER via gurney after receiving her covid vaccine. Patient was nearing the end of her 15"" of observation when she felt her heart was racing. Initial VS was 123/78, HR 143 with saturations of 100%",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Agitation', 'Anxiety', 'Diarrhoea', 'Pallor', 'Palpitations', 'Paraesthesia', 'Tachycardia', 'Tetany']",1,MODERNA,IM 937157,,56.0,F,"Headache, Myalgia, Arthralgia, lump right axillae; pain on arm Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/28/2020,4.0,OTH,,,,,,"['Arthralgia', 'Axillary mass', 'Headache', 'Myalgia', 'Pain in extremity']",1,MODERNA,IM 937160,,32.0,M,"Fever right arm pain, chills, exhaustion Narrative: Vaccine 12/28 1700 12/28 - 12/29 - overnight woke up several times feeling sick. He had chills. Temp was 99-100. Exhaustion. 12/30 - this morning symptoms his symptoms are still present but improved. Chills, exhaustion. Hasn't checked his temperature this morning. Right arm - hurt on 12/28 and resolved as of 12/30. He took off from work 12/29 - 12/30. 12/31 - Symptoms have all resolved as of later 12/30.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Impaired work ability', 'Malaise', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 937168,,60.0,M,Headache chills/flushing,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/27/2020,4.0,OTH,,,,,,"['Chills', 'Flushing', 'Headache']",UNK,MODERNA, 937171,,63.0,F,"Myalgia, Fever, CoughWheeze, Fever 102, pain in R arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Cough', 'Myalgia', 'Pain in extremity', 'Pyrexia', 'Wheezing']",UNK,MODERNA,IM 937178,,48.0,F,Rash itching./redness at the site,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/29/2020,7.0,OTH,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash']",UNK,MODERNA, 937185,,54.0,F,"Headache, Myalgia, ""I feel flushed""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Flushing', 'Headache', 'Myalgia']",1,MODERNA,IM 937191,,62.0,F,"Headache, Myalgia, Fever, stiff arm, fatigued, and loss of appetite",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Decreased appetite', 'Fatigue', 'Headache', 'Musculoskeletal stiffness', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 937204,,54.0,F,Headache & Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/28/2020,,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 937210,,39.0,M,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/29/2020,,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 937217,,63.0,M,"Myalgia, Fever, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 937223,,65.0,F,"Headache, Myalgia, Fever, NauseaVomiting, Chills, soreness L arm Narrative: Tmax 101 F",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,Adverse Event to the Zoster Vaccine,,"['Body temperature increased', 'Chills', 'Headache', 'Myalgia', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 937234,,36.0,F,Myalgia fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Fatigue', 'Myalgia']",UNK,MODERNA, 937242,,46.0,F,Dizziness & NauseaVomiting Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Dizziness', 'Nausea', 'Vomiting']",1,MODERNA,IM 937246,,42.0,F,Rash day 1-3 mild arm soreness;day 4 she is reporting hives to injection site area and swollen lymph nodes to right neck. Narrative: reports on day 1-3 mild arm soreness. On day 4 she is reporting hives to injection site area and swollen lymph nodes to right neck.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Injection site urticaria', 'Lymphadenopathy', 'Pain in extremity', 'Rash']",1,MODERNA,IM 937252,,42.0,F,Myalgia & NauseaVomiting Narrative: She had covid in the past 90 days and has body aches like she felt during the Covid illness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Myalgia', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,IM 937256,,51.0,F,"Headache, Fever, fatigue, muscle spasms 12/29 received the vaccine. Woke up tired on 12/30. That night woke up with muscle spasms all over her body and took her temp which was 101. The muscle spasms stopped at 0300 on 12/31. After that she developed a migraine. Headache last 22 hours and then just went away. She was tired the following day 1/1. All symptoms resolved on 1/2. She received the first vaccine in the ED and is scheduled to receive the second one in the ED as well. She has h/o anaphylaxis to food and bugs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Migraine', 'Muscle spasms', 'Pyrexia']",1,PFIZER\BIONTECH,IM 937260,,46.0,F,"Headache, Myalgia, NauseaVomiting, Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",UNK,MODERNA, 937269,,52.0,F,"Headache, Myalgia & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia', 'Nausea', 'Vomiting']",UNK,MODERNA, 937270,,57.0,F,"Headache, Myalgia, UrticariaPruritus, NauseaVomiting, Swelling at injection site Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Headache', 'Injection site swelling', 'Myalgia', 'Nausea', 'Pruritus', 'Urticaria', 'Vomiting']",UNK,MODERNA, 937271,,71.0,M,Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,['Fatigue'],UNK,MODERNA, 937272,,51.0,F,"c/o itching palms 15 minutes after immunization that did not travel to any other areas. No other c/o Narrative: Vaccine given at 1410 and c/o itching on palms at 1425. Pt. stated sensation was ""faint and subtle, gradually became more noticeable after 15 minutes post vaccination. Cetirizine 10mg, given po at 1440: BP 155/89, P 72, R20, O2Sat. 99%. @ 1500: BP 144/90, 75, 18, 100% o2sat; @ 1510 and prior to discharge: BP 136/85, 79, 18, 100% o2sat. Stated, ""it's still itchy but it's feeling better."" Denied any breathing difficulty or itching in other areas, except Rt. palm. d/c'd back to work at 1510 in stable condition. RN explained Cetirizine and effects/possible sleepiness/drowsiness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Pruritus'],1,PFIZER\BIONTECH,IM 937273,,35.0,M,HYPERtension Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Hypertension'],1,MODERNA, 937274,,47.0,M,"Myalgia Chills Narrative: Employee reports body aches, chills, has taken Tylenol. Employee left work early. Condition improved, not yet resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Chills', 'Impaired work ability', 'Myalgia', 'Pain']",1,MODERNA,IM 937279,,1.25,F,Headache Narrative: Reported Headache this morning,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,OTH,,,,,,['Headache'],1,MODERNA,IM 937286,,39.0,M,"Myalgia both arms, neck and back",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/02/2021,2.0,OTH,,,,,,['Myalgia'],1,MODERNA,IM 937294,,52.0,M,Myalgia & NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/03/2021,3.0,OTH,,,,,,"['Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 937296,,69.0,M,"Sore right arm, flush for 10 minutes within 15 minutes of vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Flushing', 'Pain in extremity']",1,MODERNA,IM 937301,,32.0,F,"Lymphadenopathy & Breast Pain Narrative: Individual reported to EOH provider Symptoms of Lymphadenopathy, breast pain. Also test COVID + after vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/04/2020,,OTH,,,,,,"['Breast pain', 'COVID-19', 'Lymphadenopathy', 'SARS-CoV-2 test positive']",1,MODERNA,IM 937302,,34.0,F,"Light tingling/numbness on Right side down to hands and toes, then through whole body. Began feeling light-headed briefly. Narrative: Patient sat through most of anticipated monitoring time without incident, the reported tingling and numbness developing on the right side which fairly quickly expanded to entire body. Reported mild light-headedness. Continued to monitor closely without other intervention required. Patient stood up, reported feeling better and resolution of symptoms with that movement. Continued to monitor a few more minutes. Patient left area symptom-free at 12:00 with teaching of appropriate calls to make or where to return to should she be further symptomatic.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Dizziness', 'Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 937308,,62.0,M,Rash,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/31/2020,9.0,OTH,,,,,,['Rash'],1,PFIZER\BIONTECH,IM 937313,,46.0,M,"Headache, Myalgia, NauseaVomiting, FATIGUE, NASAL CONGESTION,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/25/2020,01/02/2021,8.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia', 'Nasal congestion', 'Nausea', 'Vomiting']",1,MODERNA, 937320,,38.0,F,"Rash Narrative: Pt called w/questions about taking OTC benadryl for a rash that is on her arms and legs and some on her trunk that she reports began last night, five days after receiving dose #1 of the covid vaccine on 12/30/20. Denies any other symptoms at present and is primarily concerned about reporting her rash. No history of anaphylaxis in her medical history or other allergies to food or medications are known to her. Rash appeared scattered to trunk and extremities x4, red, raised, dry bumps that do not itch at present. Agreed that 25-50mg oral benadryl would be a good choice to start, which she states she will do. She in an APRN and states she feels comfortable recognizing new or additional symptoms for which she should seek medical attention, such as difficulty breathing, rapid heart rate, worsening of rash, swelling off her face, throat or lips, or dizziness/weakness. She has family at her home as well and is not alone.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,OTH,,,,,,"['Rash', 'Rash erythematous', 'Rash papular']",1,MODERNA,IM 937333,,45.0,M,Palpitations & Hypertension,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Hypertension', 'Palpitations']",1,MODERNA,IM 937341,,42.0,F,"lymphadenopathy left axilla, induration and pruritus at injection site. Narrative: Per patient: ""So I received the injection in my left arm and now have a itchy, sore knot at the injection site. That's not the issue. My nodes under my arm are swollen and painful for which I've been taking NSAIDs with little relief. ""Really noticed it Saturday [1/2/21]. Been using a warm compress which helps a little but not much. Haven't seen anyone yet.""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,OTH,,,,,,"['Axillary pain', 'Injection site induration', 'Injection site nodule', 'Injection site pain', 'Injection site pruritus', 'Lymphadenopathy']",1,MODERNA,IM 937347,,79.0,M,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/30/2020,,OTH,,,,,,"['Headache', 'Myalgia']",1,PFIZER\BIONTECH,IM 937349,,47.0,M,"injection site pain, lymphadenopathy Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/02/2021,4.0,OTH,,,,,,"['Injection site pain', 'Lymphadenopathy']",1,MODERNA,IM 937399,,29.0,F,Itching at injection site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/04/2021,,OTH,,,,,,['Injection site pruritus'],UNK,MODERNA, 937512,,39.0,M,NAD with c/o tongue lips and rt side of face tingling ca 8 min after receiving COVID vaccination. Reaction most noticed in right cheek.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Paraesthesia', 'Paraesthesia oral']",1,MODERNA,IM 937522,,44.0,F,Arm soreness for 12/25 and 12/26-resolved 12/27 Pain in left axillary area on 1/1/2021 as well as arm soreness returned. Axillary pain resolved on 1/2/2020 and arm soreness resolved on 1/3/2020. Arm soreness for 12/25 and 12/26-resolved 12/27 Pain in left axillary area on 1/1/2021 as well as arm soreness returned. Axillary pain resolved on 1/2/2020 and arm soreness resolved on 1/3/2020.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,"['Axillary pain', 'Pain in extremity']",1,MODERNA,IM 937533,,47.0,F,"Tachycardia Lightheadedness and perioral paresthesia after vaccination; in addition to tachycardia, feeling of ""tiredness"" not felt prior to vaccination, didn't feel ""quite right"" Narrative: Employee seen in ED; most symptoms resolved without intervention. Give a script for diphenhydramine for home use. Does not appear to have been given any medications while in the ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Dizziness', 'Fatigue', 'Feeling abnormal', 'Paraesthesia oral', 'Tachycardia']",1,MODERNA,IM 937541,,32.0,M,"Myalgia, Fever, chills Myalgias chills low grade temp for 24 hrs. Returned to work and symptoms resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 937553,,63.0,F,"Headache, Myalgia, CoughWheeze, Syncope, Fatigued, chills, night sweats, mild shortness of breath, cough. Takes coumadin for protein s deficiency. Tested + for COVID on 1/4/21 Narrative: Fatigued, chills, night sweats, mild shortness of breath, cough. Takes coumadin for protein s deficiency, sees hematology. Currently taking prn tylenol, scheduled to see hematology. Tested positive for COVID on 1/4/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['COVID-19', 'Chills', 'Cough', 'Dyspnoea', 'Fatigue', 'Headache', 'Myalgia', 'Night sweats', 'SARS-CoV-2 test positive', 'Syncope', 'Wheezing']",1,PFIZER\BIONTECH,IM 937562,,54.0,M,"CoughWheeze SOB, cough Narrative: Cough, SOB. Pt tested positive for covid on 1/4/21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,OTH,,,,,,"['COVID-19', 'Cough', 'Dyspnoea', 'SARS-CoV-2 test positive', 'Wheezing']",1,MODERNA,IM 937572,,51.0,F,"Headache, Myalgia, Fever, Rash & Urticaria Pruritus",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pruritus', 'Pyrexia', 'Rash', 'Urticaria']",UNK,PFIZER\BIONTECH,IM 937577,,46.0,F,"b/l weakness in numbness starting in arm receiving vaccine shot at 0846 developed numbness in arm receiving injection which gradually spread to both arms grew to include weakness. After 30 minutes symptoms began to ease and she was released without intervention. VSS throughout. BP in 130s/80s, HR 70s, sats upper 90s. Employee kept at vaccination site until symptoms began to ease.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/24/2020,,OTH,,,,,,"['Hypoaesthesia', 'Injection site hypoaesthesia', 'Muscular weakness']",1,MODERNA,IM 937587,,45.0,F,"SkinRash chills Narrative: macular rash over the trunk anterior chest, abdomen, back and both arms",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Chills', 'Rash', 'Rash macular']",1,PFIZER\BIONTECH,IM 937596,,52.0,F,"Dizziness, Tachypnea, CoughWheeze, Palpitations, shortness of breath, throat tightness Narrative: VAccine administered at 12:15pm. At 1230pm, employee noted new cough and onset of sob/throat tightening. O2 sat 96-97% on RA, HR 110-120's, BP 123/90. Employee with a long history of environmental/food allergies, occasionally requiring epi-pen. Epi-pen (0.3mg) administered IM x1. 25 mg IV benadryl administered x1. Employee reported symptom improvement after this medication administration and was taken to the ED for further eval. In ED given IV famotidine 20mg x1. Employee monitored without any further adverse reaction. Discharged home with RX for Famotidine 20 mg twice a day for 5 days and Zyrtec 10 mg twice a day for 5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Cough', 'Dizziness', 'Dyspnoea', 'Palpitations', 'Tachypnoea', 'Throat tightness', 'Wheezing']",1,MODERNA,IM 937602,,39.0,F,Headache & Myalgia Narrative: Telephone evaluation,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 937611,,51.0,M,Metallic taste within 5 min of injection Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,OTH,,,,,,['Dysgeusia'],1,MODERNA, 937620,,44.0,F,"Headache & Fever Narrative: Employee reports experiencing headache and fevers that started a few hours after vaccine was administered, incapacitated from coming to work but not severe enough to seek medical care.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,OTH,,,,,,"['Headache', 'Impaired work ability', 'Pyrexia']",1,PFIZER\BIONTECH,IM 937646,,37.0,F,"Angioedema tingling on botton lip and chin Narrative: Patient vitals were taken on two occasions - 15 minutes apart and were stable. Patient verbalized feeling ok. No signs of edema, pain or any other discomfort.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/28/2020,,OTH,,,,,,"['Angioedema', 'Paraesthesia', 'Paraesthesia oral']",1,MODERNA,IM 937656,,57.0,F,"Headache chills, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache']",UNK,MODERNA,IM 937669,,59.0,F,"Fevers, chills, aches & pains",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 937671,,43.0,M,"Dizziness mild shortness of breath, asthma exacerbation Narrative: used albuterol inhaler at home which did help.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/02/2021,2.0,OTH,,,,,,"['Asthma', 'Dizziness', 'Dyspnoea']",1,PFIZER\BIONTECH,IM 937680,,41.0,F,"Dizziness light headed, itchiness on head, ears felt hot and red, elevated BP and elevated HR Narrative: Tool Prednisone, Hydroxazine, and Zyrtec- all previously prescribed medications for general allergies.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Blood pressure increased', 'Dizziness', 'Erythema', 'Heart rate increased', 'Pruritus', 'Skin warm']",1,PFIZER\BIONTECH,IM 937683,,33.0,F,Fever fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,OTH,,,,,,"['Fatigue', 'Pyrexia']",1,MODERNA,IM 937688,,40.0,F,"Myalgia, UrticariaPruritus, swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,01/03/2021,7.0,OTH,,,,,,"['Myalgia', 'Pruritus', 'Swelling', 'Urticaria']",1,MODERNA,IM 937693,,40.0,M,"Headache, Arthralgia & Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Pyrexia']",1,MODERNA,IM 937694,,42.0,M,neuralgia,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Neuralgia'],1,MODERNA,IM 937700,,34.0,M,"Headache, Myalgia, Fever, Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA, 937702,,49.0,F,"dyspnea on exertion, peaked on 12/31/20, now much improved but not completely resolved as of 1/4/21 Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,OTH,,,,,,['Dyspnoea exertional'],1,MODERNA,IM 937718,,38.0,F,"Fatigue, Swollen lymph node to the right axilla Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/02/2021,5.0,OTH,,,,,,"['Fatigue', 'Lymphadenopathy']",1,MODERNA,ID 937731,,37.0,M,Myalgia malaise Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Malaise', 'Myalgia']",1,MODERNA,IM 937747,,43.0,F,Myalgia Muscle twitching and spasms Narrative: Employee reports post vaccination on 12/31/2020 about 6hrs post vaccination she developed shooting pains in right arm radiating down her arm and into her neck. She states these symptoms progressed through out her entire body into the evening. She developed muscles twitching and spasm all over.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Muscle spasms', 'Muscle twitching', 'Myalgia', 'Neck pain', 'Pain', 'Pain in extremity']",1,MODERNA,IM 937942,,47.0,M,Myalgia & Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Myalgia', 'Pyrexia']",1,MODERNA,IM 937943,,36.0,F,Dizziness & Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Dizziness', 'Headache']",1,MODERNA,IM 937945,,42.0,F,"Headache, Myalgia, REDNESS, SWELLING, WARMTH, INDURATION TO INJECTION SITE ON LEFT DELTOID WITH PRURITUS; FATIGUE Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site indentation', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Myalgia']",1,MODERNA,IM 937946,,37.0,F,ErythemaMultiform urticaria/ injection site pain/swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,01/01/2021,10.0,OTH,,,,,,"['Erythema multiforme', 'Injection site pain', 'Injection site swelling', 'Urticaria']",1,MODERNA,IM 937947,,42.0,F,"Headache, Myalgia, Arthralgia & Nausea Vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,N,11/30/2020,01/04/2021,35.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 937948,,74.0,F,"ErythemaMultiform employee reports redness and warm to touch at injection site Narrative: telephone nurse triage, employee reports redness and warm to touch at injection site 9 days post vaccine administration. applied ice pack to site, but no medication or further treatment needed. employee will continue to monitor if site does not improve.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/02/2021,9.0,OTH,,,,,,"['Injection site erythema', 'Injection site pain']",1,MODERNA,IM 937949,,42.0,F,"Headache, Fever, NauseaVomiting, T102.5 No vomitting symptoms ended x 1 day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Body height', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 937951,,50.0,F,"Myalgia, Fever, sweating Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Hyperhidrosis', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 937952,,45.0,M,"Headache, Myalgia, pain in injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Headache', 'Injection site pain', 'Myalgia']",1,MODERNA,IM 937953,,62.0,F,"watery eyes, chills, sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/04/2021,6.0,OTH,,,,,,"['Chills', 'Lacrimation increased', 'Oropharyngeal pain']",1,MODERNA,IM 937955,,56.0,M,Myalgia pain at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Injection site pain', 'Myalgia']",1,MODERNA,IM 937956,,41.0,F,R AXILLARY adenopathy DAY 6- 10 RESOLVED Narrative: R AXILLARY adenopathy Day 6- 10 RESOLVED,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/29/2020,5.0,OTH,,,,,,['Lymphadenopathy'],1,MODERNA,IM 937957,,47.0,M,"Myalgia, Fever, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Fatigue', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 937958,,28.0,F,"Headache, Fever, NauseaVomiting, Fatigue, Chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA, 937959,,41.0,M,"Myalgia nerve damage, unable to move or lift arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Mobility decreased', 'Myalgia', 'Nerve injury']",UNK,MODERNA,IM 937960,,56.0,F,2 hour right sided facial numbness around mouth,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,['Hypoaesthesia oral'],1,MODERNA,IM 937962,,63.0,F,"Headache, Myalgia, Fever, SkinRash, Rash, mild symptoms Narrative: employee reports recovering from side effects, but developed rash she feels similar to shingles she had in the past",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pyrexia', 'Rash']",1,MODERNA,IM 937963,,46.0,M,"Headache, Myalgia, Fever, chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 937965,,27.0,M,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/04/2021,,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 937966,,49.0,F,"Dizziness, Headache, pins and needles injection site, one side shoulder, arm, neck pain, weakness, generalized weakness Narrative: employee considered response mild, needed a heat pack for pain relief, staying in bed on Jan 5. Taking 800 mgm ibuprofen every eight hours, has not recovered yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,"yes, stated 25 years ago flu vaccine, age 24, sick in bed, high fever, pain in all joints, out of work 3 weeks",,"['Asthenia', 'Dizziness', 'Headache', 'Injection site pain', 'Neck pain', 'Pain in extremity', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 937967,,40.0,F,"Headache sore arm, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Pain in extremity']",1,MODERNA,IM 937968,,47.0,F,"Headache, Myalgia, Fever, neck pain, chills, lightheaded Narrative: Reports that she had chills, severe body aches, fever, neck pain, fatigue, headache, and lightheadedness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Neck pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 937969,,64.0,F,UrticariaPruritus right eye swelling and itching employee presented to ED day after vaccine. was given prednisone and hydroxyzine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Eye pruritus', 'Eye swelling', 'Pruritus', 'Urticaria']",1,MODERNA,IM 937970,,61.0,M,Axillary pain and swelling left underarm 12/31/2020,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/31/2020,3.0,OTH,,,,,,"['Axillary pain', 'Oedema peripheral']",1,MODERNA,IM 937971,,47.0,F,"Headache, CoughWheeze, Fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/29/2020,,OTH,,,,,,"['Cough', 'Fatigue', 'Headache', 'Wheezing']",1,MODERNA, 937972,,55.0,F,"Headache, Arthralgia, Fever, Fatigue, Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Pyrexia']",1,MODERNA, 937973,,39.0,F,"Dizziness, Headache, NauseaVomiting, Red/swollen below injection site x 12 days. No vomitting 1/4/21 Went to employee health. No treatment-will follow up w/PCP",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Dizziness', 'Headache', 'Injection site erythema', 'Injection site swelling', 'Nausea', 'Vomiting']",1,MODERNA,IM 937974,,59.0,F,"Headache, Myalgia, Fever, NauseaVomiting, Fatigue, Chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA, 937977,,36.0,F,"Headache, NauseaVomiting, tired, sleeping more Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/28/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Hypersomnia', 'Nausea', 'Vomiting']",1,MODERNA,IM 937978,,55.0,F,"Headache, Myalgia, CHILLS/ LETHARGY/ SORE THROAT / PERIOD OF SHORTNESS OF BREATH Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Chills', 'Dyspnoea', 'Headache', 'Lethargy', 'Myalgia', 'Oropharyngeal pain']",1,MODERNA,IM 937980,,54.0,M,"Diarrhea, NauseaVomiting, chills, injection site pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Diarrhoea', 'Injection site pain', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 938182,,54.0,F,"SkinRash, Rash, Red circular area approx. 5cm that first appeared on 12/28/2020, she also reports itching at site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Erythema', 'Injection site pruritus', 'Rash']",1,MODERNA,IM 939698,,52.0,F,"Headache, Diarrhea, NauseaVomiting, lethargy, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Diarrhoea', 'Headache', 'Lethargy', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 939699,,37.0,M,"Myalgia, Arthralgia, SkinRash, Warmth, itching, and swelling at injection site. Narrative: On 2nd - 5th day post vaccination, employee experienced arthralgia and myalgia. On 6th post vaccination, employee developed swelling, itchiness, and redness at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,OTH,,,,,,"['Arthralgia', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Myalgia']",2,MODERNA,IM 939700,,59.0,F,"CoughWheeze Throat swelling, lump in throat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Cough', 'Pharyngeal swelling', 'Sensation of foreign body', 'Wheezing']",UNK,MODERNA, 939701,,49.0,F,cellulitis and lymphadenitis Narrative: emp developed redness and axillary lymphadenopathy in her lt axilla,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Erythema', 'Lymphadenopathy']",UNK,PFIZER\BIONTECH,IM 939702,,42.0,M,"Dizziness, Headache, Myalgia & fever Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,"['Dizziness', 'Headache', 'Myalgia', 'Pyrexia']",UNK,MODERNA, 939703,,35.0,F,"redness, swelling, warmth to injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA, 939704,,27.0,F,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Headache', 'Myalgia']",UNK,MODERNA, 939705,,40.0,F,Angioedema & UrticariaPruritus,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Angioedema', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 939706,,72.0,M,Dizziness Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Dizziness'],1,MODERNA,IM 939707,,47.0,M,Rash Cellulitis,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,01/02/2021,9.0,OTH,,,,,,"['Cellulitis', 'Rash']",1,MODERNA,IM 939708,,44.0,M,"Dizziness, Fever & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,OTH,,,,yes Anthrax Vaccine,,"['Dizziness', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 939709,,49.0,F,"Headache, Myalgia, Diarrhea & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Diarrhoea', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 939710,,47.0,F,"Headache, Myalgia, Fever, UrticariaPruritus, NauseaVomiting, temp 101.0 then 99.5 Chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Pruritus', 'Pyrexia', 'Urticaria', 'Vomiting']",1,PFIZER\BIONTECH,IM 939711,,42.0,F,"tired, muscle aches, sore arm, joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/27/2020,,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Myalgia', 'Pain in extremity']",1,MODERNA, 939712,,68.0,F,"Headache fatigue Narrative: vaccine date 12/28. On 12/30 in the afternoon developed severe headache, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Fatigue', 'Headache']",1,MODERNA,IM 939713,,71.0,M,"NauseaVomiting fatigue, hot flashes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/02/2021,3.0,OTH,,,,,,"['Fatigue', 'Hot flush', 'Nausea', 'Vomiting']",1,MODERNA,IM 939714,,60.0,M,Arthralgia Inflammation under axilla on 1/2/2020 arounf 10am,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,OTH,,,,yes,,"['Arthralgia', 'Inflammation']",1,MODERNA,IM 939715,,57.0,F,"Headache, Myalgia, Fever, NauseaVomiting, T 99.6, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,yes/shingles vaccine similar symptoms but no N/V,,"['Body temperature increased', 'Chills', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 939716,,64.0,F,Headache fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache']",UNK,MODERNA, 939717,,55.0,F,"Headache, Myalgia & Fever Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 939718,,58.0,F,"hives, burning sensation around mouth",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Burning sensation', 'Urticaria']",1,PFIZER\BIONTECH,IM 939720,,59.0,F,unilateral swollen glands (right side) Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/03/2021,5.0,OTH,,,,,,['Lymphadenopathy'],UNK,MODERNA, 939722,,35.0,F,Headache Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Headache'],UNK,MODERNA, 939816,,54.0,F,NauseaVomiting dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Dizziness', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 939839,,1.08,F,warm sensation chest area,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Chest discomfort', 'Feeling hot']",1,PFIZER\BIONTECH,IM 939854,,56.0,F,Rash Narrative: large rash at site of vaccine in left arm upper,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/31/2020,9.0,OTH,,,,,,['Vaccination site rash'],1,MODERNA,IM 939862,,25.0,F,"Headache, NauseaVomiting, chills, fatigue Narrative: reports about 30 hours after vaccine developed a headache. about 48 hours had flu-like s/s, chills, nausea, fatigue, denies other s/s. These flu like s/s resolved within 24 hours, but headache continues, in milder form.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Influenza like illness', 'Nausea', 'Vomiting']",1,MODERNA,IM 939867,,33.0,F,"Headache, Myalgia, Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia']",1,MODERNA,IM 939871,,63.0,F,"Headache tingling hands and lips, tongue felt thick/swollen Narrative: 12/30 given vaccine in the ED due to a shellfish allergy for which she carries an epipen. Pt experienced mild symptoms c/w allergic reaction after receiving Pfizer COVID vaccine #1. Symptoms included tingling lips and sensation of swollen tongue. She was given Diphenhydramine 50mg PO. Condition did not progress and her symptoms resolved within about one hour of oral Diphenhydramine. She was observed for 3 hours and discharged to home with prescriptions for an epipen and benadryl. Employee states - ""15 min after the vaccination my hands got tingly on the palms. 5-10 min after that the front of my lips were tingly then my tongue felt thick. I also got a headache They gave me benadryl pills in the ED and within 10 min tingling on my lips went away and my tongue felt normal. My headache also went away."" She was discharged from the ED back to work and reports no other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Headache', 'Paraesthesia', 'Paraesthesia oral', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 939877,,64.0,F,Headache & Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Pyrexia']",1,PFIZER\BIONTECH,IM 939885,,,M,Headache & NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/1983,12/30/2020,13851.0,OTH,,,,,,"['Headache', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 939892,,35.0,F,"Dizziness, Headache & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Dizziness', 'Headache', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 939897,,63.0,F,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],1,PFIZER\BIONTECH,IM 939905,,58.0,F,Headache & Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/30/2020,,OTH,,,,,,"['Headache', 'Pyrexia']",1,PFIZER\BIONTECH,IM 939910,,62.0,F,L arm cellulitis,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/31/2020,9.0,OTH,,,,flu shot,,['Cellulitis'],1,MODERNA,IM 939913,,36.0,M,Myalgia Narrative: Employee reports all over muscle soreness and almost immediate onset s/p injection. Symptoms resolved within 36 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Myalgia'],2,PFIZER\BIONTECH,IM 939917,,46.0,F,"Myalgia, Fever, Pain in arm and armpit, swelling at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Axillary pain', 'Injection site swelling', 'Myalgia', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA, 939945,,57.0,F,Headache & Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 939950,,51.0,F,"CoughWheeze fatigue, runny nose, chest congestion Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Cough', 'Fatigue', 'Respiratory tract congestion', 'Rhinorrhoea', 'Wheezing']",1,MODERNA,IM 939958,,47.0,F,"swelling of left axilla with redness, and hot to the touch",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Erythema', 'Oedema peripheral', 'Skin warm']",1,MODERNA,IM 939976,,52.0,F,"Arthralgia, Diarrhea, NauseaVomiting, Chills, fatigue, Positive COVID test 9/11/2020",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Diarrhoea', 'Fatigue', 'Nausea', 'Vomiting']",1,MODERNA,IM 939980,,36.0,M,"Fatigue, Cough Narrative: On the day of vaccination patient reported cough and fatigue. Went and received a chest x-ray.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Chest X-ray', 'Cough', 'Fatigue']",1,MODERNA,IM 939982,,50.0,F,"Myalgia,SkinRash, Rash, HYPERtension, Pain at the insertion site, myalgia, rash to neck & back, itchiness to the throat Narrative: Developed pain at the insertion site and myalgia on 12/31/2020 1 hour after vaccination. On 01/01/21 developed rash to the neck & back and itchiness to the throat. She was seen at ER on 01/01 with a temp of 36.8 C, B/P 175/90, and HR 102. She was given Solu-u-Medrol 125mg IVP, Pepcid 20mg IVP, and Benadryl 25mg IVP. Symptoms resolved and B/P post treatment 125/80. Discharged home with Prednisone 40mg x 5day PO, Vistaril 25mg Q 6 hours PRN, and Pepcid 20mg x 5 days PO. Reports today 01/2/21 rash completely resolved. Has a history of allergic reaction to antibiotics. Reports had an anaphylaxis reaction to cephalosporin 4 years ago requiring a Epi injection in the ER. Reports history of allergic reaction to antibiotics; PCN, Macrolide, and Fluoroquinolones treated with High Dose Steroids.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Hypertension', 'Injection site pain', 'Myalgia', 'Rash', 'Throat irritation']",1,MODERNA,ID 939992,,40.0,F,"Redness, warmth to injection site; 5x6cm area of redness, warmth on left deltoid when seen by EOH on 12/21/2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,OTH,,,,,,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,IM 939994,,34.0,F,arm pain Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,['Pain in extremity'],UNK,MODERNA,IM 939999,,55.0,M,Arthralgia right arm soreness; numbness & tingling upper lip 12/29 12:15 received the vaccine. 12/30 0600 woke up with a sore arm and joint aches. 12/31 woke up with numbness and tingling across her enter upper lip. It is constantly present. Her sore arm and joint aches have improved. She denies all other symptoms. 12/31 later in the day her lip tingling resolved as did her sore arm and joint aches.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Arthralgia', 'Hypoaesthesia oral', 'Pain in extremity', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 940002,,1.08,M,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia']",UNK,MODERNA, 940003,,41.0,F,"Headache, Myalgia & Fever Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 940004,,39.0,M,"Headache, Myalgia, Fever, fatigue Narrative: Called Occ Health to report flu like s/s, fever, fatigue, full body myalgias, headache onset approx. 30 hours post injection. improved some this AM, but not completely resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Influenza like illness', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 940005,,56.0,F,"WARMTH, SWELLING, PAIN BEGAN ON 12/26/20 AND WORSENING SINCE THAT TIME. 8x8cm ERYTHEMATOUS, INDURATED, CALORIC AREA NOTED UPON ASSESSMENT 12/30/20.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/26/2020,3.0,OTH,,,,,,"['Erythema', 'Feeling hot', 'Induration', 'Pain', 'Swelling']",1,MODERNA,IM 940006,,38.0,M,"Headache, Myalgia, Fever, Diarrhea, Tachycardia, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia', 'Tachycardia']",1,PFIZER\BIONTECH,IM 940007,,58.0,F,"Headache, Arthralgia, Shoulder pain, chills, headache, backpain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Arthralgia', 'Back pain', 'Chills', 'Headache']",UNK,MODERNA,IM 940008,,28.0,M,"Headache fatigue, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Pain']",1,MODERNA,IM 940009,,57.0,M,"Myalgia submandibular, posterior neck, L groin lymphadenopathy, axillary lump. Narrative: employee developed first a tender axillar lump, then shortly after submandibular, L groin, and posterior neck lymph adenopathy with localized myalgias. The axillar lump appears to likely be a localized mild folliculitis.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/28/2020,5.0,OTH,,,,,,"['Axillary mass', 'Folliculitis', 'Lymphadenopathy', 'Myalgia']",1,MODERNA,IM 940010,,37.0,F,RespDepression,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Respiratory depression'],UNK,MODERNA,IM 940011,,56.0,F,"Myalgia, NauseaVomiting, per patient: ""extreme soreness in my left shoulder where the vaccine was administered, and a extreme case of upset stomach""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Abdominal discomfort', 'Injection site pain', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 940012,,64.0,F,"Headache, Myalgia, Arthralgia, Fever, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 940013,,44.0,F,"body aches, chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Chills', 'Pain']",1,MODERNA,IM 940014,,62.0,F,"Dizziness, Headache, Myalgia, & CoughWheeze Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Cough', 'Dizziness', 'Headache', 'Myalgia', 'Wheezing']",1,MODERNA,IM 940015,,1.08,M,"bilateral numbness cheeks and jaw, difficulty swallowing Narrative: College med student received COVID vaccine 30mins later had numbness in both cheeks and jaw, 40mins after vaccine he had difficulty swallowing. No SOB, No resp distress, no noticeable swelling of tongue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Dysphagia', 'Hypoaesthesia']",1,PFIZER\BIONTECH,IM 940016,,44.0,F,"fever, headache Narrative: 10 hours after receiving vaccine patient experienced fever of 101.2, headache and unable to get out of bed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Headache', 'Mobility decreased', 'Pyrexia']",1,MODERNA,IM 940017,,43.0,F,"Headache headache, sore thraot, body aches, nasal congestion and fever Narrative: On day after vaccination patient experienced headache, sore throat, body aches, nasal congestion and fever of 101. Took OTC Ibuprofen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Headache', 'Nasal congestion', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 940018,,62.0,M,itchy stomach,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/31/2020,7.0,OTH,,,,,,['Pruritus'],UNK,MODERNA, 940019,,64.0,M,Myalgia fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Fatigue', 'Myalgia']",UNK,MODERNA, 940020,,64.0,F,"arm muscle aches, backache, low grade temp Narrative: On day 1 and 2 patient experienced arm muscle aches, back ache and low grade temp of 99.7. Took OTC Motrin.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Back pain', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 940021,,26.0,F,Myalgia CHILLS ; FATIGUE Narrative: CHILLS; FATIGUE AND MYALGIA DAY 2 AND CONTINUES TO HAVE SOME FATIGUE AND MYALGIA TODAY,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Myalgia']",1,MODERNA,IM 940022,,63.0,M,Arm pain on day 1 and day 2,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Pain in extremity'],1,MODERNA,IM 940023,,40.0,F,"fatigue, achy, headache, malaise Narrative: on day 2 patient reported, fatigue, body aches, headache and malaise. Took OTC Tylenol and Nurtec prescription.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Malaise', 'Pain']",1,MODERNA,IM 940024,,43.0,M,"Headache, Myalgia & Arthralgia",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Myalgia']",1,MODERNA,IM 940025,,26.0,M,Induration and redness at injection site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/23/2020,,OTH,,,,,,"['Injection site erythema', 'Injection site induration']",1,MODERNA,IM 940026,,42.0,F,"Chills, soreness and stiffness in neck and back Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Back pain', 'Chills', 'Musculoskeletal stiffness', 'Neck pain']",1,MODERNA,IM 940027,,45.0,F,"sore arm at injection site, sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Injection site pain', 'Oropharyngeal pain']",1,MODERNA,IM 940028,,33.0,F,"headache, pain in joint/muscles, chills, fatigue, injection site pain and swelling Narrative: Took OTC Motrin",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Myalgia']",1,MODERNA,IM 940031,,,F,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,OTH,,,,,,['Myalgia'],1,MODERNA,IM 940037,,69.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 940044,,43.0,F,"neck swelling, hard to turn head Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Musculoskeletal stiffness', 'Swelling']",1,MODERNA,IM 940052,,56.0,F,UrticariaPruritus Arm pain Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/06/2021,6.0,OTH,,,,,,"['Pain in extremity', 'Pruritus', 'Urticaria']",UNK,MODERNA, 940059,,47.0,F,"Dizziness, Headache, Arthralgia, Fever, CoughWheeze, Diarrhea, sore throat, chills, injection site pain Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Cough', 'Diarrhoea', 'Dizziness', 'Headache', 'Injection site pain', 'Oropharyngeal pain', 'Pyrexia', 'Wheezing']",1,MODERNA,IM 940177,,51.0,F,"body aches, chiils, fatigue, cough, congestion Narrative: On day 3 experienced body aches, chills, fatigue, cough, sinus congestion and feel like she was hit by a bus",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/27/2020,3.0,UNK,,,,,,"['Chills', 'Cough', 'Fatigue', 'Pain', 'Sinus congestion']",1,MODERNA,IM 940179,,52.0,M,"Diarrhea, NauseaVomiting, reported runny & itchy nose lasting approximately 4 hours post-immunization Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Diarrhoea', 'Nasal pruritus', 'Nausea', 'Rhinorrhoea', 'Vomiting']",1,MODERNA,IM 940273,,31.0,F,"Injection site redness and pai, swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 940299,,49.0,M,"Nausea, hot/cold chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,"['Chills', 'Feeling of body temperature change', 'Nausea']",1,MODERNA,IM 940311,,54.0,M,"SkinRash, Rash, 8cm Oval red rash surrounding injection site. Itching started on 12/30/20. Area is non-raised with no warmth noted.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/29/2020,7.0,OTH,,,,,,"['Injection site erythema', 'Injection site rash', 'Pruritus', 'Rash']",1,MODERNA,IM 940319,,50.0,M,Fever Chills,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Chills', 'Pyrexia']",UNK,MODERNA, 940321,,62.0,F,"Myalgia, Fever, NauseaVomiting, diaphoresis lasting approximately 2 hours, feeling fatigued, onset of symptoms 0245 12/29/2020",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Fatigue', 'Hyperhidrosis', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 940329,,1.08,M,"Headache fatigue, arm swollen, insomnia Narrative: Call in to notify of headache, insomnia, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Insomnia', 'Peripheral swelling']",1,MODERNA,IM 940335,,28.0,F,Myalgia & Fever Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,OTH,,,,,,"['Myalgia', 'Pyrexia']",1,MODERNA,IM 940336,,33.0,F,"Headache, Myalgia, Arthralgia, Fever, Diarrhea, Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Arthralgia', 'Diarrhoea', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",UNK,MODERNA, 940343,,46.0,F,"Agitation, Headache, Myalgia, Fever & Tachycardia Narrative: approx. 21 hours after receiving vaccination patient started to feel flushed, skin of neck and face red, fever of 101.4, tachycardia, regular rate of 120-140 over two hours, states she feels like there is a lump in her throat. States she does not feel good and she does feel anxious which is abnormal for her. The headache started earlier in the day. She has taken 2 Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Agitation', 'Anxiety', 'Erythema', 'Flushing', 'Headache', 'Malaise', 'Myalgia', 'Pyrexia', 'Sensation of foreign body', 'Tachycardia']",1,MODERNA,IM 940353,,74.0,F,lightheaded,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 940361,,61.0,F,"Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction lasted 3 days, employee did not report to work on day 3 after vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/17/2020,1.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Impaired work ability', 'Injection site pain', 'Myalgia']",1,PFIZER\BIONTECH,IM 940375,,42.0,F,Myalgia & Fever Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 940386,,36.0,M,"Fever runny nose congestion Narrative: T 100 on 12/29, allergy like sx on 12/31",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/29/2020,7.0,OTH,,,,,,"['Body temperature increased', 'Pyrexia', 'Respiratory tract congestion', 'Rhinorrhoea']",1,MODERNA,IM 940442,,36.0,F,Headache & NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 940491,,55.0,F,Fever Chills Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Chills', 'Pyrexia']",UNK,MODERNA, 940492,,25.0,F,"ErythemaMultiform Redness, swelling, itching, pain over left deltoid began 2 days after injection and worsening since that time; upon exam 12/30/2020, 4x5cm area of erythema, induration and heat over left deltoid.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,OTH,,,,,,"['Erythema multiforme', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 940493,,46.0,F,"Sedation, Myalgia, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Fatigue', 'Myalgia', 'Sedation']",UNK,MODERNA, 940494,,36.0,F,"Headache, Myalgia, fatigue, hot flashes Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,,,,"yes FLu shot nausea, fatigue",,"['Fatigue', 'Headache', 'Hot flush', 'Myalgia']",1,MODERNA,IM 940495,,41.0,F,Influenza-like illness Narrative: Improved within 6 hrs-no medications taken,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Influenza like illness'],1,MODERNA,IM 940501,,57.0,M,"Headache, Myalgia, Arthralgia, Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia']",1,MODERNA, 940511,,33.0,F,"Lymphadenopathy (Axillary, Left Groin, Submandibular)",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/02/2020,,OTH,,,,,,['Lymphadenopathy'],1,PFIZER\BIONTECH,IM 940518,,40.0,M,"Drowsy, injection site pain, chills, aches/pains, weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Asthenia', 'Chills', 'Injection site pain', 'Pain', 'Somnolence']",1,PFIZER\BIONTECH,IM 940523,,51.0,M,"HEADACHE, GENERALIZED ACHES AND PAINS Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,,,OTH,,,,,,"['Headache', 'Pain']",1,PFIZER\BIONTECH,IM 940531,,60.0,M,"DIZZINESS, HYPERTENSION, TACHYCARDIA Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Dizziness', 'Hypertension', 'Tachycardia']",1,PFIZER\BIONTECH,IM 940535,,55.0,F,"INJECTION SITE PAIN, BREAST PAIN",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/21/2020,0.0,OTH,,,,,,"['Breast pain', 'Injection site pain']",1,PFIZER\BIONTECH,IM 940540,,75.0,F,"Dizzy, lightheaded, hypertensive",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Dizziness', 'Hypertension']",1,PFIZER\BIONTECH,IM 940544,,42.0,F,"NauseaVomiting, HYPERtension, Tachycardia, throat swelling Narrative: Went home after vaccine and starting vomiting, throat swelling. HR and BP elevated Went to ER was given beta blockers, in hospital for observation.",Not Reported,,Not Reported,Yes,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Blood pressure increased', 'Heart rate increased', 'Hypertension', 'Nausea', 'Pharyngeal swelling', 'Tachycardia', 'Vomiting']",1,MODERNA, 940547,,43.0,F,"Headache, Myalgia, HYPERtension, Angina, bilateral hand swelling Narrative: vaccinated in R) arm reports pain went down right arm into forearm and had bil hand swelling. Reported soon after chest pain and headache. BP elevated 190/122 P 64 did come down to 152/91 P 65. EMS called to transport for work up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/03/2020,,OTH,,,,,,"['Angina pectoris', 'Blood pressure increased', 'Chest pain', 'Headache', 'Hypertension', 'Myalgia', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 940551,,48.0,M,Headache & Tachycardia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/31/2020,10.0,OTH,,,,,,"['Headache', 'Tachycardia']",UNK,MODERNA, 940559,,24.0,F,Rash left arm pain,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/02/2020,12/25/2020,23.0,OTH,,,,,,"['Pain in extremity', 'Rash']",1,MODERNA,IM 940562,,41.0,F,injection site redness 9 days after injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,OTH,,,,,,['Injection site erythema'],1,MODERNA,IM 940571,,21.0,M,"NauseaVomiting chest tightness, throat tightness Narrative: This is a 20 year old who had a sensation of throat tightness immediately after his covid vaccine. He was transported to the ED. Treated with epi pen, solumedrol, benadryl, and pepcid. Also reports nausea which was treated with ondansetron 4m IV. Symptoms have not reoccurred. Prescription also given for epi pen. Discharged to home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Chest discomfort', 'Immediate post-injection reaction', 'Nausea', 'Throat tightness', 'Vomiting']",1,PFIZER\BIONTECH,IM 940576,,47.0,M,"Dizziness Narrative: About 20 min after injection felt pulse fast, and light headed dizzy, put ice pack on back of neck stayed extra 25 min with resolving b/p 151/80 pulse was 101 98 percent oxygen sats on room air, last b/p 130/83 pulse 80. No further symptoms or complaints all resolved. Left clinic with instructions to go to the ED any worsen symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/02/2021,,OTH,,,,,,"['Dizziness', 'Heart rate increased']",1,PFIZER\BIONTECH,IM 940581,,40.0,F,"REDNESS, SWELLING TO INJECTION SITE STARTED ON 12/23/20. 8x12 AREA OF BLANCHABLE REDNESS, CALORIC, INDURATION NOTED UPON EXAM WITH EOH ON 12/31/20.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/31/2020,9.0,OTH,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 940585,,46.0,F,"REDNESS, PAIN, SWELLING AND ITCHING TO RIGHT DELTOID INJECTION SITE INITIALLY APPEARED APPROXIMATELY 24 HOURS AFTER RECEIVING VACCINE, WENT AWAY AND RETURNED 12/30/2020 WITH WORSE SYMPTOMS. SEEN BY EOH 12/31/2020 WITH 5x6cm INDURATED, WELL DEMARCATED, ERYTHEMATOUS ARE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Induration', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Rash erythematous']",1,MODERNA,IM 940589,,34.0,M,R subclavicular lymph node swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/01/2021,9.0,OTH,,,,,,['Lymphadenopathy'],1,MODERNA,IM 940594,,43.0,F,Headache Narrative: headache on 12/26,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/26/2020,4.0,OTH,,,,,,['Headache'],1,MODERNA,IM 940600,,40.0,F,Myalgia & Fever Narrative: Fever 100 advised to stay home if febrile.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Myalgia', 'Pyrexia']",1,MODERNA,IM 940608,,64.0,M,"Headache & Myalgia Narrative: myalgias, headache, stayed home from work for a day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/28/2020,5.0,OTH,,,,,,"['Headache', 'Impaired work ability', 'Myalgia']",1,MODERNA,IM 940613,,29.0,F,Myalgia & Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,OTH,,,,,,"['Myalgia', 'Pyrexia']",1,MODERNA,IM 940625,,56.0,F,"Headache, Myalgia, Fever, R axillary lymph node swelling, fatigue Narrative: T 100, decreased to normal range with acetaminophen, r axillary lymph node swelling, headache fatigue, myalgia.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/29/2020,5.0,OTH,,,,,,"['Fatigue', 'Headache', 'Lymphadenopathy', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 940627,,51.0,F,"Headache, Myalgia, Injection site pain Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Headache', 'Injection site pain', 'Myalgia']",1,MODERNA,IM 940632,,51.0,F,"Dizziness, Headache, Myalgia, Fever, HYPERtension, Pt reported ""body felt hot while hands/feet were very cold."" Subjective fever, did not take temp., reported loss of taste, PCR covid tested on 12/30/2020 results negative Narrative: Pt remained at home and self-managed symptoms with OTC medications x48 hours. Reported for work approximately 72 hours after vaccine with no further issues reported. Had PCR covid test completed 12/20/2020 with negative results.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Ageusia', 'Dizziness', 'Headache', 'Hypertension', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 940633,,34.0,M,"Fever T 100.1, also expose to covid + husband within the last 5 days without mask",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/31/2020,,OTH,,,,,,"['Exposure to SARS-CoV-2', 'Pyrexia']",UNK,MODERNA,IM 940635,,51.0,F,"Dizziness Narrative: Pt received the vaccine at 9:28am. Approx 15-24 mins after the administration began to feel lightheaded, sweaty and flushed. Pt states this is not uncommon for her, has history of this after shots and occurs spontaneously throughout the day. Pt's face was flushed but did not develop any tongue or lip swelling, denied sob or respiratory difficulty. On exam op clear, no swelling to lips, tongue, no stridor, lungs cta bil, no wheezing, cor rrr s1s2 no m/g/r, abd soft nontender, ext no c/c/e, left upper ext injection site without redness or swelling. Vital signs were T 97.5, bp 154/97 p 95, o2 sat 97%, bp 146/80, p98, 100% 148/05 p 102 99%, 163/92 p83 o2 99%. Pt was observed for the next approx. 15-20 mins, given water and improved. Walked around the clinic with the pt who felt comfortable to be discharged. She was instructed to monitor her symptoms, follow up with her primary md regarding pretreatment prior to second vaccine and to go straight to the ED if her symptoms progress or worsen. Pt understood and agreed with instructions. Pt works in the facility and will be around medical personnel until 8pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,OTH,,,,"yes, pt states when she was young she would experience similar reactions to becoming flush, sweaty and dizzy according to her mo",,"['Dizziness', 'Flushing', 'Hyperhidrosis']",1,PFIZER\BIONTECH,IM 940646,,46.0,F,"Myalgia, NauseaVomiting, Reported neck stiffness, joint pain and nausea lasting approximately 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Arthralgia', 'Musculoskeletal stiffness', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 940652,,40.0,F,"Headache, Myalgia, left axilla enlarged lymph node Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Headache', 'Lymphadenopathy', 'Myalgia']",1,MODERNA,IM 940659,,56.0,M,"Headache, Myalgia & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 940668,,54.0,F,"Headache, Myalgia NA Narrative: Employee has h/o migraine headache that she uses replax intermittently for more than 10 years. Employee claimed after she got the covid vaccine , she developed light head. Then She started having headache that got worse progressively. She stated that she took her routine medication with no relief. She took more doses than usual, in addition to Tylenol. Stated that headache continued till the following day, that she called off work, 12/30/20. She said she slept the whole day yesterday and headache had subsided. She denied dizziness, nausea and vomiting.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Dizziness', 'Headache', 'Hypersomnia', 'Impaired work ability', 'Myalgia']",UNK,MODERNA,IM 940681,,42.0,F,"Myalgia Arm sore at injection site, decreased range of motion throughout",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Injection site pain', 'Joint range of motion decreased', 'Myalgia']",1,MODERNA,IM 940682,,64.0,F,"Dizziness, HYPERglycemia, Hx. DM c/o dizziness. Hs. DM. Accucheck was 345. took her sliding scale insulin and said she would take her BP med when she got home. BP 193/83, P. 60, O2sat 100%.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Dizziness', 'Hyperglycaemia']",1,PFIZER\BIONTECH,IM 940692,,51.0,F,"Dizziness, Headache, NauseaVomiting & HYPERtension Narrative: Seen in ED at hospital for ha fatigue muscle soreness dizziness and hypertension. CT head found incindental cyst on brain, eval by neurologist findings sx not related to finding.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/27/2020,5.0,OTH,,,,,,"['Computerised tomogram head abnormal', 'Dizziness', 'Fatigue', 'Headache', 'Hypertension', 'Myalgia']",1,MODERNA,IM 940693,,46.0,M,"Dizziness, Palpitations, erythema 3 cm area at injection site l arm Narrative: Palpitations intermittently today, hemodynamically stable on exam, and ekg nsr. Advised to hydrate rest and avoid caffiene alcohol stress rtc or seek er care if persist/worse. denies chest pain. Consulted with attending physician, employee plans to work today",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,OTH,,,,,,"['Dizziness', 'Electrocardiogram normal', 'Haemodynamic test normal', 'Injection site erythema', 'Palpitations']",1,MODERNA,IM 940696,,1.08,M,"fatigue, shoulder pain, chills, fever Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/23/2020,,OTH,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Pyrexia']",1,MODERNA,IM 940702,,77.0,M,Erythema induration 5 cm area warmth at vaccine site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,OTH,,,,,,['Vaccination site erythema'],1,MODERNA,IM 940705,,55.0,M,"Swelling, itching, redness and induration 1 week after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/30/2020,6.0,OTH,,,,,,"['Erythema', 'Induration', 'Pruritus', 'Swelling']",1,MODERNA,IM 940717,,66.0,M,"Nausea Vomiting c/o nausea, no vomiting Narrative: Felt nauseated about 15-20 min. after immunization. vss. Given water and felt better and said he felt ok to return to work. D/C'd in stable condition to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Nausea'],1,PFIZER\BIONTECH,IM 940721,,57.0,M,"Headache, Myalgia, Arthralgia, Fever & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 940734,,61.0,F,Arthralgia & Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Arthralgia', 'Pyrexia']",UNK,MODERNA,IM 940743,,47.0,F,"Myalgia, Arthralgia & Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Arthralgia', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 940748,,52.0,F,"Myalgia, Fever & CoughWheeze Narrative: PT was self-treating fever at home with appropriated OTC medications/dosage",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Cough', 'Myalgia', 'Pyrexia', 'Wheezing']",UNK,MODERNA,IM 940752,,47.0,F,"Headache, Arthralgia, Diarrhea, NauseaVomiting, fatigue, injection site pain Narrative: left work at noon on 12/31/20",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Arthralgia', 'Diarrhoea', 'Fatigue', 'Headache', 'Impaired work ability', 'Injection site pain', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 940763,,37.0,F,"Dizziness, Headache, NauseaVomiting, 12/30 worst migraine 12/31 migraine, severe nausea, lightheaded, dizziness 1/4 felt like fainting and went home from work 1/6 head heavy, dizziness. Narrative: 12/30 worst migraine took Midol and then Excedrin with no relief, 12/31 migraine, severe nausea, lightheaded, dizziness 1/4 felt like fainting and went home from work 1/6 head heavy, dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Dizziness', 'Head discomfort', 'Headache', 'Impaired work ability', 'Migraine', 'Nausea', 'Vomiting']",1,MODERNA,IM 940768,,44.0,F,ErythemaMultiform swelling at site of injection Narrative: employee experiencing swelling & redness in arm apx 10min post injection. vital signs stable at 133/82 HR 78 O2 97% T 98.4 RR16. no further symptoms after 30min monitoring. returned to clinic at 1430 with increased redness/swelling w/new onset of itching near injection site. VS: 138/83 HR 69 O2 96% T99 RR 16. Admin 50mg IV Benadryl. code team arrived and took to ED for further monitoring.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,UNK,,,,,,"['Erythema multiforme', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",UNK,PFIZER\BIONTECH, 940771,,37.0,F,golf ball size swelling in armpit on injection side. Left Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,OTH,,,,,,['Oedema peripheral'],1,MODERNA,IM 940776,,40.0,M,"Employee returned to vaccination area at 13:45, reported mild intermittent tingling in hands and feet bilat; primarily feet and primarily when he sat down. Also reported mild brief blotchiness to bilat lower forearms. Narrative: Mildly anxious, mild reactions to which he was unsure if he should return to vaccination site or not. Denied dizziness, light-headedness, palpitations. Reported mild feeling of a 'rush' ""kind of feeling, like, stimulated"". VS: at 13:46: BP 14977. O2 99%, P 79, T 36.3. Reported he had been continuing doing his duties without difficulty but didn't know if he should be concerned. Noted blotchiness on forearms under different lighting when he went to restroom. Blotchiness mild to moderate and mostly resolved before he left. VS at 14:02: BP 136/69, O2 99%, P 80, T 36.7. Reported tingling mostly resolved if he stretches his legs out some. Reported anxiety over ""the whole thing. It's just weird and I've been excited about the vaccine"". Reviewed S/S to be aware of, when to seek medical attention and that he was feeling completely stable and comfortable before he left. Positively reactive to increased information and seeing improvement in blotchiness. Left at 14:08.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Anxiety', 'Feeling abnormal', 'Paraesthesia', 'Rash macular']",1,PFIZER\BIONTECH,IM 940777,,46.0,F,"Myalgia, Fever, Rash, fatigue, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Myalgia', 'Pyrexia', 'Rash']",UNK,MODERNA, 940786,,41.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],1,PFIZER\BIONTECH,IM 940789,,59.0,M,"Myalgia, Arthralgia, 12/29 myalgias/arthralgias, soft stool 12/30 fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/29/2020,6.0,OTH,,,,,,"['Arthralgia', 'Faeces soft', 'Fatigue', 'Myalgia']",1,MODERNA,IM 940796,,42.0,F,Myalgia Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Fatigue', 'Myalgia']",1,MODERNA,IM 940802,,52.0,M,"BlurredVision, UrticariaPruritus, numness face and tongue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/31/2020,,OTH,,,,,,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Pruritus', 'Urticaria', 'Vision blurred']",1,PFIZER\BIONTECH,IM 940803,,40.0,F,"Headache arm soreness, redness Narrative: Rash noticed to injection site 12/31/2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Erythema', 'Headache', 'Injection site rash', 'Pain in extremity']",1,MODERNA,IM 940807,,57.0,F,"CoughWheeze c/o chest congestion. Hx. of asthma. Used her Albuterol inhaler and ""felt better"" Vaccinated at 1041 AM, c/o ""feels like chest congestion, tickling in throat"" at 1117. Hx. Asthma; used her Albuterol inhaler PRN at home and used it at 1117. after 2-3 minutes she said she felt better. BP148/71, P 88, R 16, O2Sat 96% at 1117; at 1125 BP 140/72, P 84, R 18, O2 sat 99%.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Cough', 'Pulmonary congestion', 'Throat irritation', 'Wheezing']",1,PFIZER\BIONTECH, 940814,,53.0,F,"Myalgia severe arm pain, redness",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Erythema', 'Myalgia', 'Pain in extremity']",1,MODERNA,IM 940817,,63.0,M,"Dizziness cough (allergies, per Pt.) noted; appeared anxious Narrative: c/o dizziness. given juice. HX. HTN. @0945 BP 170/81, P. 93, R 18, O2 96%; @ 0955 BP 143/76, P. 89, R 18, O2 97%; @ 1005, BP 175/82, P. 87, R. 18, O2sat 97%. Sent to ED for further evaluation. Given IV fluids for dehydration. resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,09/30/2020,12/29/2020,90.0,OTH,,,,,,"['Anxiety', 'Cough', 'Dehydration', 'Dizziness', 'Rhinitis allergic']",1,PFIZER\BIONTECH,IM 940818,,65.0,M,Fever 100.5 Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Pyrexia'],1,MODERNA,IM 940824,,49.0,F,"SkinRash flushed face noted with rash around neck Narrative: @1348 noted face flushed and rashes around neck. BP 132/80, P 96, R 18, O2 sat 100%, T 98.6 Given Cetirizine 10 mg po and observed for 30 minutes. @ 1405 BP 123/65, P 65, R 18. Resolved and d/c'd at 1410. Updated in employee record on database",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Flushing', 'Rash']",1,PFIZER\BIONTECH,IM 940825,,,M,Headache & Diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/31/2020,7.0,OTH,,,,,,"['Diarrhoea', 'Headache']",1,MODERNA,IM 940826,,44.0,F,"Headache chills, fatigue, body aches Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pain']",UNK,MODERNA, 940832,,38.0,F,"Dizziness, Headache & RespDepression Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Dizziness', 'Headache', 'Respiratory depression']",1,MODERNA,IM 940834,,62.0,F,extreme tiredness and chills,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Chills', 'Fatigue']",1,MODERNA,IM 940836,,1.08,F,Myalgia Throbbing pain on both arms,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Myalgia', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 940841,,52.0,F,"Dizziness, HYPOtension, blurred vision Narrative: Reaction at 30 min- Dizziness, blurred vision, B/P dropped to 95/55- She stayed in ER until 11am, No Sxs of breathing issues or SOB. She was NOT admitted, just observed until B/P went up. Vaccine was given in the ED- reason not given.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Blood pressure decreased', 'Dizziness', 'Vision blurred']",1,PFIZER\BIONTECH,IM 940843,,43.0,F,"Right arm red, sore, tender at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Injection site erythema', 'Injection site pain']",1,MODERNA,IM 940845,,49.0,F,Tachypnea Panic Narrative: Employee experienced panic response w/tachycardia up to 105 BPM. BP stable 144-147/84-90 throughout response. Benadryl 50mg admin @1650. Code team arrived assessed employee and took to ED,Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/29/2020,,OTH,,,,,,"['Panic reaction', 'Tachypnoea']",UNK,PFIZER\BIONTECH,IM 940846,,41.0,F,"Fever, Tachycardia, CHILLS Narrative: PULSE WAS 115 FOR ABOUT 3 HOURS. TOOK TYLENOL AND NO FEVER, CHILLS OR HIGH PULSE NEXT MORNING",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Chills', 'Heart rate increased', 'Pyrexia', 'Tachycardia']",UNK,MODERNA, 940853,,43.0,F,UrticariaPruritus,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Pruritus', 'Urticaria']",1,MODERNA,IM 940854,,48.0,F,"Headache, Myalgia, Rash, Hypoglycemia, subjective tachycardia (heart racing) Narrative: Within minutes of vaccination, employee experienced sternocleidomastoid tenderness/tightness on the side of the vaccination with a feeling of her heart racing. She was transferred to the ED. Evaluation revealed mild rash, vital signs stable, normal oxygen saturation, no SOB, normal sinus rhythm on EKG. No evidence of pulmonary involvement, lung sounds clear. Assessment: Mild allergic reaction. After 5 hours of observation in the ED, patient experienced resolution of her subject tachycardia. She was treated for a headache with APAP during her stay, and reports improvement. She also had a mild hypoglycemia and was given ginger ale and graham crackers. Discharged to home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Hypoglycaemia', 'Muscle tightness', 'Myalgia', 'Rash', 'Tachycardia']",1,PFIZER\BIONTECH,IM 940858,,49.0,F,"NauseaVomiting Narrative: Seen in the ED for nausea with 1 episode of vomiting after receiving COVID- 19 vaccine. Questionable covid 19 vaccine reaction of nausea. No evidence of serious allergic reaction, no rash, no trouble breathing. Nausea improved with zofran. No indication for benadryl or other allergy medications at this time. Patient has been observed in the ER for several hours and no new symptoms developed. Will DC home with strict return precautions.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 940863,,43.0,M,"SWEATING ANXIETY, HEADACHE, NAUSEA, SWEATING AT APPROXIMATELY 1410. HR 100-105. OBSERVED 5 MINUTES. DENIED SOB. NO TACHYPNEA, RASH OR ORAL SWELLING. NO AUDIBLE WHEEZING OR STRIDOR. SENT TO ER AT 2:19 FOR OBSERVATION. OBSERVED 1 HOUR.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Anxiety', 'Headache', 'Hyperhidrosis', 'Nausea']",UNK,PFIZER\BIONTECH,IM 940867,,1.08,M,RespDepression,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Respiratory depression'],UNK,MODERNA, 940869,,44.0,F,"SkinRash & Tachycardia Narrative: Staff member received the vaccine approximately @ 1030hrs. States she felt flush, tachycardic right after the vaccine. They developed a rash on her neck, chest and face.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/29/2020,,OTH,,,,,,"['Flushing', 'Rash', 'Tachycardia']",1,MODERNA,IM 940870,,39.0,M,"Headache hot flashes. fatigue, runny nose",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Hot flush', 'Rhinorrhoea']",UNK,MODERNA, 940872,,51.0,F,"Headache, Sedation, CHILLS Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Chills', 'Headache', 'Sedation']",UNK,MODERNA, 940875,,33.0,F,SkinRash COLD SENSATION RADIATES DOWN LEFT ARM Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Feeling cold', 'Rash']",1,PFIZER\BIONTECH,IM 940876,,51.0,M,"Headache, Sedation & Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Headache', 'Pyrexia', 'Sedation']",UNK,MODERNA, 940879,,57.0,F,Myalgia & Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Myalgia', 'Pyrexia']",1,MODERNA,IM 940881,,34.0,M,"Headache, Myalgia, UrticariaPruritus, NauseaVomiting, metallic taste, LN Swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Dysgeusia', 'Headache', 'Lymphadenopathy', 'Myalgia', 'Nausea', 'Pruritus', 'Urticaria', 'Vomiting']",1,MODERNA,IM 940882,,66.0,M,"Myalgia, NauseaVomiting, Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Fatigue', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 940885,,42.0,F,"Myalgia, Fever, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 940886,,56.0,F,"SkinRash, CoughWheeze & Syncope",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Cough', 'Rash', 'Syncope', 'Wheezing']",1,PFIZER\BIONTECH,IM 940887,,48.0,F,"Dizziness, Headache, Myalgia, Fever, NauseaVomiting, l arm swollen at site, no redness/warm to touch, extreme fatigue (malaise)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Dizziness', 'Fatigue', 'Headache', 'Injection site swelling', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 940888,,32.0,F,"Pt. c/o of tingling and tightness in the back of the throat and a warm feeling over her body. Alert and oriented Narrative: Pt. c/o of tingling and tightness in the back of the throat and a warm feeling over her body. 126/77, P 81, R 18 O2 sat at 96.1% at 1420; @ 1435 106/67, P. 65, R 16, O2 sat 99%; @ 1444 BP 115/63, P 67, R 17, O2 sat 100%.Symptoms resolved ay 1435 and denied any c/o. D/c'd in stable vs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Feeling hot', 'Pharyngeal paraesthesia', 'Throat tightness']",1,PFIZER\BIONTECH,IM 940889,,56.0,M,Feels very cold like ice on left arm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,yes. Shingrix on 11/2020. Felt chills and headache,,['Feeling cold'],1,PFIZER\BIONTECH,IM 940890,,51.0,F,"Myalgia, Arthralgia, Redness at injection site; Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Injection site erythema', 'Myalgia']",1,MODERNA,IM 940891,,34.0,F,cellulitis Narrative: left arm cellulitis surrounding injection site approx 5 in in diameter,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,OTH,,,,,,['Injection site cellulitis'],1,MODERNA,IM 940892,,52.0,F,Myalgia Chills; Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Myalgia']",1,MODERNA,IM 940893,,29.0,M,"Myalgia, Arthralgia, Fever, 100.1 fever Narrative: right arm pain at site of injection fell ill a couple hours after",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Arthralgia', 'Injection site pain', 'Malaise', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 940894,,56.0,F,Diarrhea & NauseaVomiting Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 940895,,49.0,F,"Headache, Myalgia, Arthralgia, chills, pain at injection site Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Injection site pain', 'Myalgia']",UNK,MODERNA, 940896,,51.0,F,"UrticariaPruritus Itching Narrative: employee c/o itching to scalp, leg, and face; 25mg diphenhydramine PO administered. employee reported symptoms have resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/31/2020,,OTH,,,,,,"['Pruritus', 'Urticaria']",1,MODERNA,IM 940897,,65.0,F,"Palpitations Pt. felt like she was having palpitations. VS stable. Narrative: c/o dizziness and palpitations about 20 min. after getting covid 19 immunization; described by pt. as a ""very fast heartbeat"". P. 96 regularly in the 60's normally, per pt. @ 1320, BP 127/64, P 96, R 16, O2Sat 96%; at 1324 BP 124/57, P 88, R 16, O2 sat. 97%; @ 1337, BP 130/67, P 89, R 16, O2 sat..98%. d/c'd back to work at 1350 resolved. Updated in employee record.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Dizziness', 'Heart rate increased', 'Palpitations']",1,PFIZER\BIONTECH,IM 940898,,49.0,F,Headache & NauseaVomiting Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/22/2020,5.0,OTH,,,,,,"['Headache', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 940899,,66.0,F,"Dizziness severe arm soreness and reduced ROM, severe fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Dizziness', 'Fatigue', 'Joint range of motion decreased', 'Pain in extremity']",1,MODERNA,IM 940900,,30.0,F,"Dizziness, Headache, Myalgia & Fever Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Dizziness', 'Headache', 'Myalgia', 'Pyrexia']",UNK,MODERNA,IM 940901,,34.0,F,"Headache, Myalgia, NauseaVomiting, Chills and pain at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Chills', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 943404,,52.0,M,SORENESS AT INJECTION SITE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 943422,,38.0,F,Fever & CoughWheeze,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/26/2020,2.0,OTH,,,,,,"['Cough', 'Pyrexia', 'Wheezing']",UNK,MODERNA,IM 943454,,57.0,F,Myalgia Painful injection site with redness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Injection site erythema', 'Injection site pain', 'Myalgia']",1,MODERNA,IM 943459,,58.0,M,"Myalgia, Fever, Diarrhea, Injection site sore, stiff neck and upper back, feet& calves swollen, chills, temp 100.0 degrees",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Body temperature increased', 'Chills', 'Diarrhoea', 'Injection site pain', 'Musculoskeletal stiffness', 'Myalgia', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 943465,,47.0,M,"Headache, Fever, chills, trouble sleeping Narrative: Reports that he woke up at 1 am with chills, headache, trouble sleeping, and temp of 101 degrees",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Chills', 'Headache', 'Pyrexia', 'Sleep disorder']",1,MODERNA,IM 943473,,53.0,M,"Dizziness, Headache, Myalgia, Arthralgia & Diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Arthralgia', 'Diarrhoea', 'Dizziness', 'Headache', 'Myalgia']",1,MODERNA,IM 943476,,41.0,M,Headache migraine,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/30/2020,,OTH,,,,,,"['Headache', 'Migraine']",1,PFIZER\BIONTECH,IM 943480,,43.0,F,Headache Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,OTH,,,,,,['Headache'],1,PFIZER\BIONTECH,IM 943485,,40.0,M,"Headache, Myalgia & NauseaVomiting Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia', 'Nausea', 'Vomiting']",UNK,MODERNA, 943489,,31.0,F,Fever & Nausea Vomiting Narrative: fever of 99.9 and N/V.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 943494,,47.0,F,"Headache, Myalgia & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 943499,,35.0,F,Headache FATIGUE,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache']",1,MODERNA,IM 943508,,42.0,M,"Headache, Diarrhea & NauseaVomiting Narrative: a few hours after the injection, he developed diarrhea, nausea, vomit once, and headache. The diarrhea, vomit and nausea resolved by the next AM, but the headache continued for 2 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 943512,,42.0,F,UrticariaPruritus SMALL HIVES,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 943517,,58.0,F,"Dizziness, Arthralgia, congestion",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Arthralgia', 'Dizziness', 'Respiratory tract congestion']",1,MODERNA, 943522,,65.0,F,"NauseaVomiting Narrative: Received vaccine on 12/28/2020 . Was doing well until one hour before the call. C/O of abdominal cramp, distention, nausea. No vomiting, temperature was 99.7F. No similar episodes before. No rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Abdominal distension', 'Abdominal pain', 'Body temperature increased', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 943527,,56.0,F,"Headache, Myalgia, Chills, edema (L upper extremity)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Oedema peripheral']",1,MODERNA, 943530,,69.0,M,"Headache, Myalgia, NauseaVomiting, Fatigue, ""Brain Feels Foggy""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Fatigue', 'Feeling abnormal', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 943540,,46.0,F,Headache generalized weakness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,"['Asthenia', 'Headache']",1,MODERNA,IM 943545,,25.0,F,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia']",1,PFIZER\BIONTECH,IM 943558,,47.0,F,"Headache, Fever, ""low grade fever, chills, fatigue, and headache. I went to bed early and felt better this morning. Only residual feeling I have today is arm discomfort at injection site.""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Injection site discomfort', 'Pyrexia']",1,MODERNA,IM 943569,,36.0,M,"CoughWheeze Fatigue, shortness of breath Narrative: Symptoms MAY be Covid; will test for Covid",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Cough', 'Dyspnoea', 'Fatigue', 'Wheezing']",1,MODERNA,IM 943574,,42.0,F,"Headache, CoughWheeze, ErythemaMultiform, fatigue, chills, low temp, swollen glands, injection site hard, red, ""itchy""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Chills', 'Cough', 'Erythema multiforme', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Lymphadenopathy', 'Pyrexia', 'Wheezing']",1,MODERNA,IM 943580,,36.0,F,"Rash, UrticariaPruritus, EMPLOYEE STATES ITCHING AND RASH DEVELOPED ON 12/25/20 ON LT BUTTOCK WHICH HAS CONTINUED UNTIL NOW; NO FOLLOW-UP;",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/25/2020,2.0,OTH,,,,,,"['Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 943581,,56.0,F,"Headache cold/chills; Itchy (head, arms, legs); stomach ache; fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Abdominal pain upper', 'Chills', 'Fatigue', 'Headache', 'Nasopharyngitis', 'Pruritus']",1,MODERNA,IM 943594,,64.0,M,Myalgia pain at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Injection site pain', 'Myalgia']",UNK,MODERNA, 943601,,62.0,M,Myalgia sore arm for 48 hours Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Myalgia', 'Pain in extremity']",UNK,MODERNA, 944392,,34.0,M,"Dizziness & HYPOtension Narrative: Pt reported feeling dizzy and faint about 10 min post vaccination. Pt was noticeably diaphoretic. Vital sign machine was unable to take BP initially, but next readings came back low 90s/60s. Pt was observed for additional 15 minutes and felt better so was released.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,Pt reported he gets similar reactions to vaccinations and blood draws in the past,,"['Dizziness', 'Hyperhidrosis', 'Hypotension']",1,MODERNA, 946913,,61.0,F,Dizziness THROAT FELT TIGHT Narrative: Anaphylactic reaction to injectable medication in past (gadolinium contrast),Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Dizziness', 'Throat tightness']",1,MODERNA,IM 946922,,62.0,M,Dizziness Fatigue Narrative: The patient is improving daily as of 12.30.2020.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Dizziness', 'Fatigue']",1,MODERNA,IM 946932,,59.0,F,"Headache, Arthralgia & CoughWheeze Narrative: reports 10 hours post injection, arthralgias and spasms in low back and hips, resolved within 12 hours. She reports the next day, 14 hours mild knee pain (no h/o knee pain), completely resolved. 40 hours out developed headache, initially responsive to Tylenol, then stopped being so, kept her awake at night had a cough for three hours while awake last night), and then today she is leaving work early because of 7/10 headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Arthralgia', 'Cough', 'Headache', 'Impaired work ability', 'Muscle spasms', 'Sleep disorder', 'Wheezing']",1,MODERNA,IM 946940,,60.0,U,"Headache, Myalgia & Nausea Vomitin",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 947168,,52.0,F,NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Nausea', 'Vomiting']",1,MODERNA,IM 947175,,38.0,M,"UriticariaPruritus, NauseaVomiting, Pain and difficulty moving left arm, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Fatigue', 'Mobility decreased', 'Nausea', 'Pain in extremity', 'Pruritus', 'Urticaria', 'Vomiting']",1,MODERNA,IM 947181,,46.0,F,"Dizziness, Myalgia, ErythemaMultiform & Diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Diarrhoea', 'Dizziness', 'Erythema multiforme', 'Myalgia']",1,MODERNA,IM 947183,,67.0,M,"Myalgia, Fever, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Fatigue', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 947192,,45.0,F,"Rash Narrative: Employee received Covid 19 vaccine (Pfizer) at 2:30 pm, developed rash 4:30pm, presented to clinic on 12/30/2020 rash still present with some itching. Seen by MD advised Benadryl and to seek medical attention for any increase in symptoms such as SOB.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH,ID 947202,,21.0,M,"NauseaVomiting, HYPERtension, Tachycardia, chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,yes,,"['Chills', 'Hypertension', 'Nausea', 'Tachycardia', 'Vomiting']",1,MODERNA,IM 947209,,67.0,F,"UrticariaPruritus Tingling of upper lip and under eyes Narrative: 12:45 stated upper lip felt fingly and under eyes; VS 73, r 16, BP 1589/90, sat 98%. ambulated to MD office Evaluated by Dr. Benadryl ordered (25mg PO x 1 dose) and given at 1305). Ambulated back to personal office, called friend to pick up after work. 1330, 72, 16, 96%, 135/82, denies worsening of symptoms, no rash or hives noted. No symptoms of difficulty breathing, swelling of face or tongue, increased heart rate, rash or dizziness or head ache. Assessment and follow up by M.D.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Paraesthesia', 'Paraesthesia oral', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 947212,,61.0,F,"ErythemaMultiform Narrative: Redness below injection site, warm to touch, sore on palpation",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/31/2020,9.0,OTH,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 947353,,58.0,F,"Headache, Fever, chills, temp 104.0 last night this AM 102.0, this evening 101.7, pain at inj site red w/edema Narrative: temps of 104.0last night , 102.0 this am now 101.7",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/28/2020,,OTH,,,,,,"['Chills', 'Headache', 'Injection site erythema', 'Injection site oedema', 'Injection site pain', 'Pyrexia']",1,MODERNA,IM 947367,,40.0,F,Dizziness Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,['Dizziness'],1,MODERNA,IM 947375,,50.0,F,Diarrhea CHILLS Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Chills', 'Diarrhoea']",1,MODERNA,IM 947384,,41.0,F,"Headache arm sore, axilla sore with swollen lymph nodes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Axillary pain', 'Headache', 'Lymphadenopathy', 'Pain in extremity']",1,MODERNA,IM 947418,,63.0,F,"HYPERtension, Syncope Hx. HTN and did not take BP meds in the morning. also anxious about immuniation. Narrative: History of recent stress test with pending results. pt. c/o lightheadedness while seated in recliner during observation. Per pt., she feels anxious after witnessing another person have a syncopal event. BP 240/98, P 76, R 22, O2 sat. 99% at 0935. RRT in the area so they assessed the pt. and convinced her to go to ED to be checked out. D/c'd per w/c to the ED with RRT. ED reported BP 190/108 in the ED. States she did not take BP meds in the morning and was anxious about her immunization today. ED reported she took her Losartan at 4pm. Discharged from the ED. Recorded on employee medical file on database.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Anxiety', 'Dizziness', 'Hypertension', 'Syncope']",1,PFIZER\BIONTECH,IM 947446,,64.0,F,Headache & NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 947457,,67.0,M,"Headache, Myalgia, chills, malaise, runny nose Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Chills', 'Headache', 'Malaise', 'Rhinorrhoea']",1,MODERNA,IM 947462,,59.0,M,"UrticariaPruritus Narrative: pt was given 50mg diphenhydramine orally and itching resolved within 15""; she ambulated out of clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Pruritus', 'Urticaria']",1,MODERNA,IM 947468,,62.0,M,"Headache, Fever & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Headache', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 947474,,48.0,F,"HYPERtension & Tachycardia Narrative: Tachycardia at 160 within 5"" of injection with mild hypertension from 128/90 to 167/95 for 2-3""; resolution to HR of 110 and BP 139/80 within 5"". Transferred to ED for further monitoring in stable condition, awake, alert and cooperative, mentation intact.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Hypertension', 'Tachycardia']",1,MODERNA,IM 947486,,35.0,F,"Narrative: Nausea and anxiety reported. Relieved by putting head to knee. BP 160/81, P 66, R 20, O2 sat. 97% at 1150; BP 153/74, P 51 , R 20 @ 1155; BP 127/75, P 51, R 18, O298%. Given water to drink; vital improved. Symptoms resolved and was monitored for 30 min.. Verbalized she felt better and was d/c'd to work. Documentation created by MA, RN on form and filed in medical file.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Anxiety', 'Nausea']",1,PFIZER\BIONTECH,IM 947497,,44.0,F,"sore throat, esophageal pain, globus sensation Narrative: 12/23/2020 - felt like she had a lump in her throat. This persisted to 12/24/2020. on 12/25/2020 developed centralized chest pain and discomfort. No history of heartburn or indigestion. 12/25/2020 - went to ER. Diagnosed with esophageal spasm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Chest discomfort', 'Chest pain', 'Oesophageal spasm', 'Sensation of foreign body']",UNK,MODERNA,IM 947505,,37.0,F,"Myalgia, Fever, sinus congestion Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Myalgia', 'Pyrexia', 'Sinus congestion']",1,MODERNA,IM 947509,,49.0,M,"UrticariaPruritus 9X7 cm induration Narrative: 9X7 cm pruritic, erythematous , warm induration 7d after Vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,OTH,,,,,,"['Induration', 'Pruritus', 'Rash erythematous', 'Skin warm', 'Urticaria']",1,MODERNA,IM 947519,,63.0,M,Arthralgia arm pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Arthralgia', 'Pain in extremity']",1,MODERNA,IM 947529,,47.0,F,"Headache, Myalgia, Fever, Diarrhea, chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Diarrhoea', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 947540,,51.0,F,"UrticariaPruritus & NauseaVomiting Narrative: 1000-Patient stated right hand itching no hives seen; VS-126/84;P-76;R-16;SAT-100%; MD at bedside to evaluate. Denies Respiratory difficulties; CP. 1007-Patient states nauseated, RRT at bedside, patient trying to vomit, turned to right side. Dr. from RRT ordered Epi 0.3mg/ml to be given, Epi administered to left thigh, EMS called. 1015- VS; P-69;R-16;BP-110/72, Sat-98, EMS on scene. Patient A & O x4. No difficulty breathing, loaded on EMS stretcher. 1022- VS-127/63; P-73; R-16: Sat-96 and capnography-41. Patient left T205 via EMS at 1022.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Nausea', 'Pruritus', 'Urticaria', 'Vomiting']",1,PFIZER\BIONTECH,IM 947548,,37.0,F,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,OTH,,,,,,['Myalgia'],1,PFIZER\BIONTECH,IM 947558,,57.0,F,"Headache, Myalgia, NauseaVomiting, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA, 947565,,51.0,F,"Headache, CoughWheeze, NauseaVomiting, Chest tightness Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,OTH,,,,,,"['Chest discomfort', 'Cough', 'Headache', 'Nausea', 'Vomiting', 'Wheezing']",1,MODERNA,IM 947575,,64.0,M,"Fever chills, headaches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Chills', 'Headache', 'Pyrexia']",1,MODERNA,IM 947582,,42.0,M,"Myalgia, Arthralgia, neck, shoulder pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Arthralgia', 'Myalgia', 'Neck pain']",1,MODERNA,IM 947588,,44.0,F,SkinRash Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,['Rash'],UNK,PFIZER\BIONTECH,IM 947597,,43.0,F,"Headache & Fever Narrative: Employee reports having chills, fever 100.4, headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Chills', 'Headache', 'Pyrexia']",1,MODERNA,IM 947610,,38.0,M,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia']",1,PFIZER\BIONTECH,IM 947623,,38.0,F,"Headache, Myalgia, malaise, pain at injection site. Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Headache', 'Injection site pain', 'Malaise', 'Myalgia']",1,MODERNA,IM 950272,,51.0,F,"Headache joint pain, weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Arthralgia', 'Asthenia', 'Headache']",UNK,MODERNA, 950273,,47.0,F,"fatigue, malaise Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/30/2020,10.0,OTH,,,,,,"['Fatigue', 'Malaise']",UNK,MODERNA, 950274,,41.0,M,CoughWheeze Chest congestion,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/29/2020,6.0,OTH,,,,,,"['Cough', 'Pulmonary congestion', 'Wheezing']",UNK,MODERNA, 950275,,63.0,F,ABDOMINAL CRAMPING,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Abdominal pain'],1,MODERNA,IM 950276,,1.08,M,"Headache, Myalgia, fever 100.9",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 950277,,20.0,M,"Headache, Myalgia & Arthralgia Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/30/2020,,OTH,,,,,,"['Arthralgia', 'Headache', 'Myalgia']",UNK,MODERNA,IM 950278,,47.0,M,erythema warmth swelling at injection site 3 cm area,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,OTH,,,,,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 950279,,36.0,F,"SkinRash History of allergy to Fluarix (SOB and hives, treated with Benadryl and recovered); latex and seafood Narrative: Dr. present assessed employee. Mild localized uticaria left upper arm. Resolved after observation 40 min.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,yes,,"['Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 950280,,40.0,F,"Palpitations & HYPERtension Narrative: 143/94 98, 100% on RA, 98.2 degrees, rr 14 at 1457. 158/96, 97, 100% on RA, rr 16 at 1501. Denied headache, rash, SOB, uticaria. 138/87, 85, 100% on RA at 1530. Denied dizziness and palpitations. History of palpitations. History of anaphylaxis allergy to IV iodine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/30/2020,,OTH,,,,,,"['Hypertension', 'Palpitations']",1,PFIZER\BIONTECH,IM 950281,,54.0,M,"Patient complained a ""metallic"" taste soon after receiving he vaccine. Symptoms resolved within 30 minutes. No other symptoms or side effects reported. Patient complained a ""metallic"" taste soon after receiving he vaccine. Symptoms resolved within 30 minutes. No other symptoms or side effects reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Dysgeusia', 'Immediate post-injection reaction']",1,PFIZER\BIONTECH,IM 950282,,41.0,F,Myalgia fatigue Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Fatigue', 'Myalgia']",UNK,MODERNA, 950283,,39.0,M,Headache & Tachycardia Narrative: 1/5 received the vaccine. Woke up in the middle of the night with heart rate to 115-116. Resting heart rate is normally 45. This morning his heart rate was still elevated to 100 range. Has slight headache which developed 1/6 around 9:30. He drank water and it's improved. His heart rate is about 95 BPM at 10:30 on 1/6. He denies all other symptoms. He didn't sleep well because of the fast heart rate so he feels fatigued today.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Heart rate increased', 'Sleep disorder', 'Tachycardia']",2,PFIZER\BIONTECH,IM 950284,,65.0,F,Myalgia fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Fatigue', 'Myalgia']",UNK,MODERNA, 950285,,32.0,F,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 950286,,51.0,M,Myalgia fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Fatigue', 'Myalgia']",UNK,MODERNA, 950287,,46.0,M,"Fever L arm pain, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Fatigue', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 950288,,53.0,F,"SkinRash, Rash, 8 days post shot has redness to sight, warm and slightly swollen. size 4inchX5inch pink/red area. Escorted to ER for follow up cares. Narrative: Mild cellulitis at Moderna injection site. No systemic signs Prescribed Cephalexin and told to follow up with PCP",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,OTH,,,,,,"['Injection site cellulitis', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Rash']",1,MODERNA,OT 950289,,66.0,F,"Dizziness, Arthralgia, PAIN AT INJECTION SITE,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Arthralgia', 'Dizziness', 'Injection site pain']",UNK,MODERNA,IM 950290,,56.0,F,"NauseaVomiting Per patient: ""I had severe nausea for 2 days. For 1 1/2 days, I stayed in bed"". Soreness at injection site since day of vaccination. Narrative: Further information per patient: ""I felt the nausea as soon as I woke up Friday morning. I took meclizine and stayed in bed. The nausea continued to Saturday but I was able to drink something and get out of the bed. I never was able to eat anything Friday or Saturday but got out of bed and sat on the sofa, Saturday. Sunday morning I felt much better and was back to my baseline. My arm is still painful since 12/31 but it's not infected"".",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Decreased appetite', 'Injection site pain', 'Nausea', 'Vomiting']",1,MODERNA,IM 950291,,49.0,M,"Headache chills, 99 degree F temp, tired for 24 hours, soreness at injection site, body aches, mild nausea Narrative: employee gave consent for information to be share with FDA and CDC, felt that event was not over yet, still experiencing some chills at time of interview, Jan 6, 2021, 10:30am.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pain']",UNK,PFIZER\BIONTECH, 950292,,58.0,F,Headache Narrative;,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Headache'],UNK,MODERNA, 950293,,45.0,F,extreme fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Fatigue'],UNK,MODERNA, 950294,,37.0,F,Headache neck pain/injection site soreness Narrative: injection site soreness lasted 24 hours; neck soreness for 36 hours; headache for several days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,OTH,,,,,,"['Headache', 'Injection site pain', 'Neck pain']",1,PFIZER\BIONTECH, 950295,,46.0,M,flu like symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,OTH,,,,,,['Influenza like illness'],1,MODERNA,IM 950296,,57.0,M,facial flush Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/06/2021,,OTH,,,,,,['Flushing'],1,MODERNA,IM 950297,,42.0,F,SkinRash,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,OTH,,,,,,['Rash'],UNK,MODERNA,IM 950298,,37.0,F,"Headache, ErythemaMultiform & UrticariaPruritus Narrative: p vaccine fatigue, tired. 12/31/2020 fatigue body ache no fever,temp 99. redness soreness ejction site c hard bump. HX of migraines. 1/4/2021 itchy ness at injection site. 1/5/2021migrain to R side of head, R ear pressure, itchy ness, redness, swelling, warm to touch at injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Condition aggravated', 'Ear discomfort', 'Erythema multiforme', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Migraine', 'Pain', 'Pruritus', 'Urticaria']",1,MODERNA,IM 950299,,51.0,F,"Large, red, raised, painful injection site reaction with bruising up to 2 weeks later Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Injection site bruising', 'Injection site erythema', 'Injection site pain', 'Rash papular']",1,PFIZER\BIONTECH,IM 950300,,24.0,F,"ErythemaMultiform, UrticariaPruritus, also swollen lymph nodes, tightness, painful, tender to touch and some movement on injection site armpit Narrative: 5 days post vaccination swollen lymph nodes on injection site armpit. tightness, painful, tender to touch and some movement on injection site armpit. No treatment used. Erythema and itchiness at injection site as well. Hydrocortisone 1% PRN applied to area.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,OTH,,,,,,"['Erythema multiforme', 'Injection site erythema', 'Injection site movement impairment', 'Injection site pain', 'Injection site pruritus', 'Lymphadenopathy', 'Pruritus', 'Skin tightness', 'Urticaria']",1,MODERNA,IM 950301,,42.0,F,"Nausea, Fatigue, flushing Narrative: Patient experienced 3 days of nausea, fatigue and flushing. Took over the counter Pepcid and Naproxen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Fatigue', 'Flushing', 'Nausea']",1,MODERNA,IM 950302,,66.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Headache'],UNK,MODERNA, 950303,,40.0,M,Influenza-like illness Narrative: Pt took ibuprofen for symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Influenza like illness'],1,MODERNA,IM 950304,,66.0,M,Dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Dizziness'],UNK,MODERNA, 950305,,40.0,F,"Dizziness, Headache, Myalgia & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Dizziness', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 950306,,44.0,M,Headache & Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Headache', 'Pyrexia']",1,MODERNA,IM 950307,,55.0,F,"Headache, NauseaVomiting, Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 950311,,50.0,F,"Headache, Myalgia & Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 950313,,42.0,F,"sore throat, muscle chest tightness, throat irritation Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Chest discomfort', 'Muscle tightness', 'Oropharyngeal pain', 'Throat irritation']",1,MODERNA,IM 950315,,62.0,F,"Headache, Fever, Rash, UrticariaPruritus, fatigue,pain,itching, swelling and warm to touch at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pruritus', 'Pyrexia', 'Rash', 'Urticaria']",1,MODERNA,IM 950317,,29.0,F,"Headache,Myalgia, chills, felt hot all over but temp normal, nasal congestion, injection site soreness Narrative: 12/29 got vaccine. 12/30 feet and hands felt cold. then she felt hot all over. her temp was normal. Then she developed nasal congestion and a headache. Later in the evening she developed body aches and injection site soreness. She took tylenol. 12/31chills have resolved. She has ongoing body aches, feels hot, headache. She called in sick 12/31. Symptoms resolved as of Jan 2.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Body temperature normal', 'Chills', 'Feeling hot', 'Headache', 'Impaired work ability', 'Injection site pain', 'Myalgia', 'Nasal congestion', 'Pain', 'Peripheral coldness']",1,PFIZER\BIONTECH,IM 950319,,1.08,F,Headache & Arthralgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Arthralgia', 'Headache']",1,MODERNA,IM 950321,,52.0,F,"Headache, Myalgia, nasal congestion, rhinorrhea, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/29/2020,2.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Nasal congestion', 'Rhinorrhoea']",1,MODERNA,IM 950323,,52.0,F,Diarrhea numbness of face/tongue Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Hypoaesthesia', 'Hypoaesthesia oral']",1,PFIZER\BIONTECH,IM 950326,,53.0,M,"Headache, Myalgia & Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,"yes, only tireness persists",,"['Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 950329,,55.0,F,Fever & CoughWheeze Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,OTH,,,,,,"['Cough', 'Pyrexia', 'Wheezing']",1,MODERNA,IM 950333,,51.0,F,Dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Dizziness'],1,MODERNA,IM 950338,,56.0,F,"Headache Narrative: EMployee reports ""horrible"" headache, chills, body aches. Employee was unable to attend work and called in sick.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/31/2020,,OTH,,,,,,"['Chills', 'Headache', 'Impaired work ability', 'Pain']",1,MODERNA,IM 950340,,62.0,F,"Headache weakness, lost of taste Narrative: Informed employee to go get COVID tested since employee reported loss of taste, headache, muscle aches, and weakness. Employee understood and stated that she would.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/30/2020,6.0,OTH,,,,,,"['Ageusia', 'Asthenia', 'Headache', 'Myalgia']",UNK,MODERNA, 950343,,47.0,F,"Myalgia, NauseaVomiting, Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Fatigue', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 950345,,60.0,F,"allergy like symptoms, runny nose",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/30/2020,6.0,OTH,,,,,,"['Hypersensitivity', 'Rhinorrhoea']",UNK,MODERNA, 950348,,74.0,M,Myalgia & Arthralgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Arthralgia', 'Myalgia']",UNK,MODERNA, 950372,,36.0,F,"Headache, Myalgia & Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pyrexia']",UNK,MODERNA,IM 950375,,60.0,U,fatigue; itching at injection site (no rash or reddness) Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Fatigue', 'Injection site pruritus']",1,MODERNA,IM 950377,,43.0,M,"Headache, Myalgia, NauseaVomiting, Fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 950379,,52.0,M,Headache & NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Headache', 'Nausea', 'Vomiting']",UNK,MODERNA, 950382,,39.0,F,Headache & NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Headache', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 950384,,51.0,M,"Dizziness, Headache, Myalgia, CoughWheeze, self report temp: 100.9 on 12/29; ~99.0 on 12/30 Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Body temperature increased', 'Cough', 'Dizziness', 'Headache', 'Myalgia', 'Wheezing']",1,MODERNA,IM 950388,,50.0,F,Diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,['Diarrhoea'],UNK,MODERNA, 950392,,63.0,F,Headache Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/28/2020,,OTH,,,,,,"['Fatigue', 'Headache']",1,MODERNA,IM 950396,,39.0,F,"lymphadenopathy, arm swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/29/2020,6.0,OTH,,,,,,"['Lymphadenopathy', 'Peripheral swelling']",1,MODERNA,IM 950400,,36.0,F,"Headache, Fever, UrticariaPruritus, NauseaVomiting, per patient: ""fever 102... Tylenol that brings it down to 99.7, severe H/A, N/V, Hoarseness, tongue itching""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Dysphonia', 'Headache', 'Nausea', 'Pruritus', 'Pyrexia', 'Tongue pruritus', 'Urticaria', 'Vomiting']",1,MODERNA,IM 950403,,42.0,M,Dizziness & Tachycardia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Dizziness', 'Tachycardia']",1,MODERNA,IM 950407,,62.0,F,"Dizziness, Myalgia, Arthralgia & HYPERtension Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Arthralgia', 'Dizziness', 'Hypertension', 'Myalgia']",1,MODERNA, 950411,,27.0,F,"Fever Injection site pain, neck discomfort",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Injection site pain', 'Musculoskeletal discomfort', 'Pyrexia']",1,MODERNA,IM 950415,,23.0,F,"RespDepression & Bradycardia Narrative: Pt escorted in wheelchair to extended monitoring room approx 8 min after injection of potential antigen. As pt entered doorway, her head hyperextended and she lost consciousness in wheelchair. Pulse not palpable. Pupils dilated. Administered EpiPen to right lateral thigh. Pt gained consciousness in wheelchair and was transferred to stretcher. Remained diaphoretic and pale. Placed on NC 2 L. After stabilized, transferred to ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Bradycardia', 'Hyperhidrosis', 'Loss of consciousness', 'Mydriasis', 'Pallor', 'Pulse absent', 'Respiratory depression']",UNK,PFIZER\BIONTECH, 950418,,39.0,F,"Dizziness, NauseaVomiting, Palpitations, Tachycardia, None Narrative: Employee experienced listed symptoms appox. 1800 on 12/30. Has made it difficult to perform daily routine. All non listed vitals within normal limits.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,OTH,,,,Timeresol reaction d/t preservative. Localized.,,"['Dizziness', 'Loss of personal independence in daily activities', 'Nausea', 'Palpitations', 'Tachycardia', 'Vomiting']",1,MODERNA,IM 950422,,60.0,F,"Headache, Myalgia, exhaustion",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia']",1,MODERNA,IM 950425,,39.0,F,Headache malaise,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Headache', 'Malaise']",1,MODERNA,IM 950428,,49.0,F,"Myalgia, Fever, swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Hyperhidrosis', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 950431,,59.0,F,Teeth pain and loss of taste,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Ageusia', 'Toothache']",1,MODERNA,IM 950433,,36.0,F,SkinRash,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,OTH,,,,,,['Rash'],1,MODERNA,IM 950436,,58.0,M,"Myalgia, Fever, swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Myalgia', 'Pyrexia', 'Swelling']",1,MODERNA,IM 950438,,55.0,F,"Fever 101 temp and malaise since vaccination on 1/4/21 @0930, symptoms began 24 hrs later (body aches and induration at injection site). Febrile on 1/5@1430 to 101. Fever at 100.5 this morning. No recurrence but still very fatigued.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,,,,yes - flu vaccine body aches.,,"['Fatigue', 'Injection site induration', 'Malaise', 'Pain', 'Pyrexia']",1,MODERNA,IM 950443,,43.0,M,"Tachypnea, Angina, Tachycardia, Sore Muscles Narrative: Started feeling ill on the 28th. Drove himself to get checked out at the hospital. Hospital sent him home. Called EMS at 12/30/2020 @ 0200 and was hospitalized for 1 day. He is more stable now but still has these symptoms at a moderate level.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Angina pectoris', 'Malaise', 'Myalgia', 'Tachycardia', 'Tachypnoea']",1,MODERNA,IM 950447,,67.0,F,Rash,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,['Rash'],1,MODERNA,IM 950450,,52.0,M,Myalgia Injection site pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Injection site pain', 'Myalgia']",UNK,MODERNA,IM 950454,,55.0,F,"Headache, Fever, Tachycardia, rigor, lightheaded, back ache, BP 80/50, admitted to ER for observation from 11 am to 5 pm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Back pain', 'Chills', 'Dizziness', 'Headache', 'Pyrexia', 'Tachycardia']",1,PFIZER\BIONTECH,IM 950457,,49.0,F,"Headache, Myalgia, ARM PAIN,CHILLS,LIGHT HEAD Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Chills', 'Dizziness', 'Headache', 'Myalgia', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 950465,,25.0,M,"NauseaVomiting chills, ""brain zaps""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Chills', 'Nausea', 'Paraesthesia', 'Vomiting']",1,MODERNA,IM 950471,,39.0,M,"Arm pain, felt ""spacy-mental fog"" for about 6 hours Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Feeling abnormal', 'Pain in extremity']",1,MODERNA,IM 950473,,32.0,F,"Headache, Fever, 99- 100.0",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Headache', 'Pyrexia']",1,PFIZER\BIONTECH,IM 950477,,55.0,F,CoughWheeze Itchy throat Received 1st dose of Moderna Vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Cough', 'Throat irritation', 'Wheezing']",1,MODERNA,IM 950485,,31.0,M,"Headache, Arthralgia, Fever, R arm soreness, chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Pain in extremity', 'Pyrexia']",1,MODERNA, 950490,,55.0,F,Headache chills,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Chills', 'Headache']",UNK,MODERNA, 950496,,38.0,F,"Dizziness, Headache, Myalgia, Arthralgia, NauseaVomiting, Injection site pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Arthralgia', 'Dizziness', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 950501,,42.0,F,"Diarrhea left arm pain; abdominal pain 12/22 - vaccinated 12/23 onset of left arm pain and couldn't lift her arm. 12/24 arm pain improved. 12/25 felt normal and healthy 12/26 stomach sharp pain, diarrhea and felt shaky. 12/30 tested negative for COVID-19. 12/31 - symptoms persisted through today and have improved for the first time today. Left with only mild abdominal ache. Not sure the abdominal symptoms are related to the vaccine. She was advised to seek medical care if symptoms persist or worsen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Abdominal pain', 'Diarrhoea', 'Mobility decreased', 'Nervousness', 'Pain in extremity', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 950505,,50.0,F,"Headache, Myalgia, Fever, Headache, sore muscles, fever and sore throat Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Headache', 'Myalgia', 'Oropharyngeal pain', 'Pyrexia']",UNK,MODERNA,IM 950507,,31.0,F,"Headache, Myalgia, Arthralgia, NauseaVomiting, Injection site pain, fatigue, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 950508,,63.0,F,Headache FAtigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache']",1,MODERNA,IM 950509,,43.0,F,redness pain edema at inj site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Injection site erythema', 'Injection site oedema', 'Injection site pain']",1,PFIZER\BIONTECH,IM 950510,,38.0,F,"FEELING FLUSHED, MILD FACIAL FLUSHING Narrative: 0825 C/O FEELING HOT , MILD FACIAL FLUSHING 120/84 P101 99% RA R 18 0837: 50MG BENADRYL GIVEN IM, 0841: C/O DRY MOUTH, FEELING SHAKY 0834: 124/83 P 102 99.4 100% RA 0850: C/O DRY MOUTH, COLD 0840: 118/77 P: 104 100% RA 100% RA.... 0855: 118/84 P101 100% RA T 99.0 0905: TRANSPORTED BY EMT",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Dry mouth', 'Flushing', 'Hot flush', 'Nasopharyngitis', 'Nervousness']",1,PFIZER\BIONTECH,IM 950511,,51.0,F,"Headache, Myalgia, Arthralgia, NauseaVomiting, Fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA, 950512,,50.0,F,Headache Left arm pain Narrative: 12/29 - onset of left arm pain. 12/30- onset of headache. 12/31 headache still present but improve. Arm is mildly sore - much better,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 950513,,62.0,F,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,['Myalgia'],1,MODERNA, 950514,,31.0,F,"Rash erythema, swelling and itching to site of injection Narrative: employee presented with itching, erythema, and swelling to site of injection past 48 hours of injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/28/2020,5.0,OTH,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 950551,,38.0,F,"Myalgia Chills,fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Myalgia']",1,PFIZER\BIONTECH,IM 950557,,53.0,F,"flushed and lips tingling within minutes of vaccination. After 30 min, nearly resolved. Employee declined PO Benadryl but was provided one ""to go"".",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Flushing', 'Paraesthesia oral']",1,MODERNA,IM 950563,,51.0,F,"Rash, NauseaVomiting, pruritus Narrative: Developed dry heaves, rash and itching 9 min after receiving COVID vaccine (1st dose) during observation; Epipen given in vaccination room; transferred to R by ambulance. In ER she was given Diphenhydramine 25 mg PO and Famotidine 20 mg PO. Observed for 1-1/2 hours and discharged.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Nausea', 'Pruritus', 'Rash', 'Retching', 'Vomiting']",1,PFIZER\BIONTECH,IM 950575,,36.0,F,flushed feeling,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Flushing'],2,MODERNA,IM 950580,,56.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,['Myalgia'],1,MODERNA, 950581,,1.08,F,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Headache', 'Myalgia']",2,MODERNA,IM 950582,,49.0,F,Employee reported on 12/30/20 that she noticed a pea-size knot on left chest wall below clavicle with soreness after vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,OTH,,,,,,['Nodule'],1,MODERNA,IM 950583,,40.0,F,"Sedation, Myalgia, Diarrhea, pain and chills also reported Narrative: Employee notes approximately 48 hours of COVID like symptoms, similar but milder than what they experienced with the infection. Noted extreme fatigue, pain, diarrhea, chills and muscle aches with resolved after approximately 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,OTH,,,,,,"['Chills', 'Diarrhoea', 'Fatigue', 'Myalgia', 'Pain', 'Sedation']",1,PFIZER\BIONTECH,IM 950584,,45.0,F,"Headache, Myalgia & Angina",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/27/2020,4.0,OTH,,,,,,"['Angina pectoris', 'Headache', 'Myalgia']",1,PFIZER\BIONTECH,IM 950585,,65.0,F,"Fever, NauseaVomiting, fatigue, numbness and tingling right arm and leg.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Fatigue', 'Hypoaesthesia', 'Nausea', 'Paraesthesia', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 950586,,34.0,F,"Rash, UrticariaPruritus, Injection site rash, pruritus Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,OTH,,,,,,"['Injection site rash', 'Pruritus', 'Rash', 'Urticaria']",1,MODERNA, 950587,,41.0,F,Metallic taste in mouth,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Dysgeusia'],UNK,PFIZER\BIONTECH,IM 950588,,44.0,M,Myalgia & Arthralgia,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Arthralgia', 'Myalgia']",1,MODERNA, 950589,,56.0,M,Myalgia Mild left arm soreness 1 hour after receiving the vaccine and generalized malaise/myalgia Narrative: Employee reports mild left arm soreness 1 hour after receiving the Vaccine and generalized malaise/myalgia.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Malaise', 'Myalgia', 'Pain in extremity']",1,MODERNA,IM 950590,,31.0,F,UrticariaPruritus HIVES ON ARM AND BACK Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Pruritus', 'Rash', 'Urticaria']",UNK,PFIZER\BIONTECH,IM 950591,,52.0,M,"Dizziness, Palpitations & HYPERtension Narrative: Employee received vaccine this AM at approximately 0853 this AM, Patient was monitored for 30 minutes after receiving vaccine based on employees verbal report of having a prior reaction to the flu vaccine about 10 years ago. The employee reported having heart palpitations and it felt like ""heart was beating out of chest"" while on duty after the observation period was complete. The employee returned to the vaccine clinic for further evaluation and was assessed and vitals were taken. Employee was noted to have a heart rate around 105-110s and a BP of 170s/ 90s which the employee stated was ""unusual"". The employee was then monitored for an additional 30mins, which after 15 mins the employee stated ""I'm feeling really bad"" , employee reported dizziness and stated ""I feel like I'm going to pass out. The employee was started on 2L 02 via face mask and transported to the ER for further evaluation. Vitals were reassessed and found to be within normal limits. Patient verbally reported feeling much better at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/31/2020,,OTH,,,,,,"['Dizziness', 'Feeling abnormal', 'Palpitations']",1,MODERNA,IM 952088,,51.0,M,NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 952089,,50.0,F,"Patient reports scratchy throat, metallic taste in mouth, ""weird"" feeling on tongue, ""rash"" on tongue, denies tongue swelling, denies throat swelling. Benadryl 50mg PO given. Patient states symptoms did not worsen after Benadryl given. Patient reports scratchy throat, metallic taste in mouth, ""weird"" feeling on tongue, ""rash"" on tongue, denies tongue swelling, denies throat swelling. O2 saturation 99%. Benadryl 50mg PO given. Patient states ""feeling better"" and symptoms did not worsen after Benadryl given.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Dysgeusia', 'Paraesthesia oral', 'Throat irritation', 'Tongue eruption']",1,MODERNA,IM 952090,,1.08,M,"Dizziness, Headache, Myalgia, Arthralgia, Fever, mental foggy arthralgias/myalgias, chills. 12/31 fever resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Dizziness', 'Feeling abnormal', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 952091,,34.0,M,Felt Cold tingling in 4th and 5th Fingers to right hand Narrative: Pt at on site 15min observations immediately after receiving Covid-19 Vaccination Informed monitor staff of 4th and 5th finmgers on right have felt cold Monitor checked VS: BP=134/85 P=73 O2-98% BP=127/74 P=73 BP-115-75 P=73 O2-am98% Situation resolve by 1045,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/30/2020,,OTH,,,,,,"['Paraesthesia', 'Peripheral coldness']",1,PFIZER\BIONTECH,IM 952099,,53.0,F,"Dizziness, Myalgia, difficulty sleeping, dizziness arm pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Dizziness', 'Myalgia', 'Pain in extremity', 'Sleep disorder']",1,MODERNA,IM 952107,,35.0,M,"Headache, Myalgia, Arthralgia, Fever, Diarrhea, Tachycardia, HA resolved 12/29, aches chills conts. 12/31 all symptoms resolved, Covid tested negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Diarrhoea', 'Headache', 'Myalgia', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tachycardia']",1,MODERNA,IM 952117,,51.0,M,Dizziness & Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Dizziness', 'Headache']",1,MODERNA,IM 952123,,48.0,M,"Dizziness After 5 minutes after being vaccinated, pt began to feel lightheaded and dizzy and slightly short of breath, heart rate was 160 and BP was 128/90 with 100% O2 sats on 6L. After that her heart rate started to come down two minutes later to 129",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Dizziness', 'Dyspnoea', 'Heart rate increased']",1,MODERNA,IM 952124,,20.0,F,Myalgia & Arthralgia,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Arthralgia', 'Myalgia']",1,MODERNA,IM 952125,,32.0,M,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 952126,,45.0,F,"Dizziness Little wave of dizziness 100/62 HR62 O2 99%, 100/67 HR 73 Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 952127,,64.0,M,"Headache, Myalgia, Arthralgia, Fever, Right arm pain, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 952128,,36.0,M,"Headache, Fever, chills, HA and temp resolved 12/31 Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Chills', 'Headache', 'Pyrexia']",1,MODERNA,IM 952129,,37.0,M,"Left arm pain, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,"['Fatigue', 'Pain in extremity']",1,MODERNA,IM 952130,,45.0,U,"left arm pain, swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 952131,,22.0,M,"Fever soreness at injection site and arm, feels warm Narrative: No OTC meds necessary, just began.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Injection site pain', 'Injection site warmth', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 952132,,52.0,M,"Rash Injection site pain, rash, warmth and edema.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/29/2020,5.0,OTH,,,,,,"['Injection site oedema', 'Injection site pain', 'Injection site rash', 'Injection site warmth']",1,MODERNA,IM 952133,,48.0,F,Injection site pain/discomfort,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Injection site discomfort', 'Injection site pain']",1,MODERNA,IM 952134,,38.0,F,Dizziness Injection site pain,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Dizziness', 'Injection site pain']",1,MODERNA,IM 952135,,33.0,M,"Myalgia, Arthralgia, pain in Rt deltoid/shoulder with ROM>above shoulder, weakness . no sensory deficit. 12/31 arm better with IB.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Arthralgia', 'Asthenia', 'Joint range of motion decreased', 'Myalgia']",1,MODERNA,IM 952136,,1.08,F,"Headache, Myalgia, Fever, CoughWheeze, malaise, congestion Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Cough', 'Headache', 'Malaise', 'Myalgia', 'Pyrexia', 'Respiratory tract congestion', 'Wheezing']",1,MODERNA,IM 952137,,66.0,M,"Headache, Myalgia & UrticariaPruritus",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pruritus', 'Urticaria']",UNK,PFIZER\BIONTECH,IM 952138,,46.0,F,"Dizziness Left leg tingling intermittingly, BP163/107 HR 75, BP110/119 HR79 O2 98%",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Dizziness', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 952139,,59.0,F,"Headache, Myalgia, Arthralgia, Fever, SkinRash, Rash, UrticariaPruritus, NA Narrative: Employee had the Covid 19 vaccination at 14:40 pm, 12/29/20, at 15:30 pm she developed hives at the site of injection , that spread gradually to involve the whole body. There was associated itching all over the body. She stated that she took Benadryl 50mg po one time. The hives started improving and completely subsided by late night Employee claimed that she had 101.4 temperature that is responding to Tylenol 650mg q6h prn, currently 15:30,12/30/20 , the temperature is 100.4 she relates to generalized body ache, joints pain, denied shortness of breath, wheezing. Employee could not come to work today because of the fever and body ache. But she did not seek medical attention",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Arthralgia', 'Impaired work ability', 'Injection site urticaria', 'Pain', 'Pruritus', 'Pyrexia', 'Urticaria']",1,MODERNA,IM 952140,,59.0,F,Angioedema swelling and redness of face; eyes swollen Narrative: Employee was seen in the clinic the following day and symptoms had resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Angioedema', 'Erythema', 'Eye swelling', 'Swelling face']",1,PFIZER\BIONTECH,IM 952141,,50.0,F,"Fever fever, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Fatigue', 'Pyrexia']",1,MODERNA,IM 952142,,31.0,M,"fatigue, arm pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/26/2020,2.0,OTH,,,,,,"['Fatigue', 'Pain in extremity']",1,MODERNA,IM 952143,,55.0,M,"Myalgia, Arthralgia, Arm pain, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Myalgia', 'Pain in extremity']",1,MODERNA, 952144,,48.0,F,c/o funny taste 10 min after vaccination Narrative: 10 min after vaccination employee c/o funny taste. Denies numbness/tingling to lips or tongue. No difficulty swallowing. Monitored pt for 30 minutes. Emploees states funny taste has resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/30/2020,,OTH,,,,,,['Taste disorder'],1,PFIZER\BIONTECH,IM 952145,,64.0,F,"Difficulty breathing and swallowing, dry mouth Narrative: Employee vaccinated in COVID Vaccine Clinic, within 10 minutes developed throat tightness and difficulty swallowing with a dry mouth.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/30/2020,,OTH,,,,,,"['Dry mouth', 'Dysphagia', 'Dyspnoea', 'Throat tightness']",1,MODERNA,IM 952146,,34.0,F,"Headache, Fever, Fatigue Headache, fatigue, and fever starting one day after receipt of the vaccine and continuing though 5 days after vaccine. Tested negative for Covid-19 via PCR test on day 5 after vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Pyrexia', 'SARS-CoV-2 test negative']",UNK,MODERNA,IM 952147,,55.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 952148,,51.0,F,"Headache, Myalgia, Fever, NauseaVomiting, Fatigue, Chills, Joint Pain, Headache, Myalgia, Fever, Nausea Narrative: Used OTC ibuprofen and acetaminophen",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 952149,,69.0,F,Per recipient [at injection site] hard knot that is about the circumference of a golf ball and it is red. It is tender to the touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site nodule', 'Injection site pain']",1,MODERNA,IM 952150,,61.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 952151,,39.0,F,"Headache, Myalgia, Arthralgia & NauseaVomiting Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",UNK,MODERNA,IM 952152,,41.0,M,Left Axillary lymph nodes tender to palpation (swollen glands),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/28/2020,5.0,OTH,,,,,,"['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 952153,,68.0,M,Myalgia Body Aches Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/26/2020,2.0,OTH,,,,,,"['Myalgia', 'Pain']",1,MODERNA,IM 952154,,47.0,F,"Headache, Myalgia, NauseaVomiting, fever T 99.5 F",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 952155,,55.0,F,"Dizziness, Headache, Myalgia, sore throat, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Oropharyngeal pain']",1,MODERNA,IM 952156,,58.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 952158,,45.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 952165,,46.0,F,facial flushing Narrative: Reported facial flushing following vaccine administration,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Flushing'],1,MODERNA,IM 952186,,41.0,F,"Sedation, Myalgia, Immediate post vaccine, employee reported feeling ""funny"" almost like she was intoxicated. this passed after a few hours. Narrative: Employee missed greater than >1 days of work second to symptoms (aches and extreme fatigue)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Fatigue', 'Feeling abnormal', 'Immediate post-injection reaction', 'Impaired work ability', 'Myalgia', 'Pain', 'Sedation']",1,PFIZER\BIONTECH,IM 952201,,65.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 952210,,64.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 952238,,56.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 952239,,34.0,M,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia']",1,PFIZER\BIONTECH,IM 952240,,46.0,M,Myalgia fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Fatigue', 'Myalgia']",UNK,MODERNA, 952241,,67.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 952244,,39.0,F,"6x6cm indurated, erythmatous, caloric area to right deltoid, well demarcated",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Injection site erythema', 'Injection site induration']",1,MODERNA,IM 952254,,45.0,F,"Myalgia chills Narrative: 44yo Nurse Assistant. In Employee Health at 0915 hours w/ c/o myalgias, LUE pain and chills. Endorses received Moderna Vaccination on 12/29/20 at approximately 3:45pm in Left Deltoid. Uneventfully completed her tour on unit. Took 600mg of Ibuprofen prior to vaccination at 3:00pm. TOD ended at 8:00pm. Went to sleep as soon as arrived home, did not eat dinner due to tiredness from the 12 hour shift. Awoke 12/30/20 at 5:45(am) with chills and severe LUE pain. LUE pain radiates from injection site to elbow. Influenza Vaccine in September or October 2020, denies ever having a reaction other than mild injection site discomfort. Endorses h/o Influenza Type A in 2019 or 2018. PMHx: None other than Obesity. Allergies: Denies. Afebrile. 98.8F oral, HR 82bpm, RR 20, B/P 109/75 (states ""normal"" Systolic is in the 90's), SaO2 on RA 97% LUE very tender to touch, not excessively warm, no erythema, appears to be a raised, non-draining area approximately eight (8)cm in diameter; tender from injection site (band-aide was still on) to elbow. Appears to be in great discomfort with very slow guarded movements and extreme facial grimaces and grunts when asked to undress left arm for inspection. Donning Winter Coat and hat and endorses feels chilly. 11yo daughter at home not ill. States does not usually get ""colds"".",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Feeling cold', 'Injected limb mobility decreased', 'Injection site discomfort', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Pain', 'Pain in extremity']",1,MODERNA,IM 952258,,57.0,F,"Headache, Diarrhea, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Diarrhoea', 'Fatigue', 'Headache']",UNK,MODERNA,IM 952259,,36.0,F,Rash Narrative: hivea at injection site five days after injection. No therapies at ED. She has had this rash before at site of bee stings,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/28/2020,5.0,OTH,,,,,,['Injection site urticaria'],1,MODERNA,IM 952260,,58.0,F,Headache SWELLING AT INJECTION SITE AND PAIN; HA Narrative: DAY 1 AND DAY 2 SWELLING AT INJECTION SITE AND PAIN HA,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 952261,,41.0,F,"nasal congestion, sore throat Narrative: reported congestion and sore throat following vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Nasal congestion', 'Oropharyngeal pain']",1,MODERNA,IM 952262,,63.0,M,"Myalgia, Fever, ErythemaMultiform, CHILLS,SWELLING AND PAIN AT INJECTION SITE",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Chills', 'Erythema multiforme', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 952263,,42.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 952264,,46.0,F,"Myalgia chest pain, bronchial spasm Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,OTH,,,,,,"['Bronchospasm', 'Chest pain', 'Myalgia']",1,PFIZER\BIONTECH,IM 952265,,66.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 952266,,59.0,F,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 952271,,40.0,F,"NauseaVomiting flushing Narrative: Recipient experienced nausea and flushing s/p vaccination, which lasted about 15 minutes prior to spontaneously resolving. No other issues include no vomiting, shortness of breath, dizziness or diarrhea. No reported prior reactions to vaccinations. States she was feeling anxious about vaccination and had eaten prior to coming to clinic. Vital signs T98.2F, BP 104/70 (stated normal range for recipient), HR51 (stated normal range for recipient), SpO2 99% on RA. Exam benign, able to tolerate oral intake of fluids (declined offer of food) and ambulate prior to leaving vaccination area. Observed another ~8 minutes prior to request to go home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Flushing', 'Immunisation anxiety related reaction', 'Nausea']",1,MODERNA,IM 952279,,52.0,M,"Headache, NauseaVomiting, Hypertension, lightheadedness Narrative: 51 year old female presented to ED post first dose of COVID-19 vaccine on 12/28/20. Sxs reported include feeling lightheaded, mild nausea and headahce. Nausea resolved 45 minutes after injection, but headache persisted, no facial swelling or difficulty, swallowing, no continued nausea or abdominal pain. Patient was administered a one-time dose of ibuprofen 800mg in the ED at 1510, recovered, and was discharged from ED on 12/28/20 at 1535.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Dizziness', 'Headache', 'Hypertension', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH, 952287,,31.0,M,Myalgia right shoulder pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Injection site pain', 'Myalgia']",1,PFIZER\BIONTECH,IM 952293,,34.0,F,NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,OTH,,,,,,"['Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 952300,,55.0,F,"Headache, Myalgia, tireness Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia']",1,PFIZER\BIONTECH,IM 952316,,38.0,M,"HYPERtension Hot flush Narrative: BP 148/109 HR 88, patient monitored for an additional 15 minutes, repeat BP 147/97 HR 72. Patient recovered and referred to PCP for follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Hot flush', 'Hypertension']",1,PFIZER\BIONTECH,IM 952325,,63.0,M,"Myalgia, Fever, chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 952333,,55.0,F,"Headache, Myalgia, CoughWheeze, NauseaVomiting, Palpitations, Syncope, Arm pain, chills and overall weakness Narrative: Employee was unable to work second to symptoms, missing >1 days of work at time of this report.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Asthenia', 'Chills', 'Cough', 'Headache', 'Impaired work ability', 'Myalgia', 'Nausea', 'Pain in extremity', 'Palpitations', 'Syncope', 'Vomiting', 'Wheezing']",1,PFIZER\BIONTECH,IM 952340,,57.0,M,"Myalgia Fatigue, drowsy Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/29/2020,,OTH,,,,,,"['Fatigue', 'Myalgia', 'Somnolence']",1,MODERNA,IM 952525,,36.0,U,Fever Chills Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Chills', 'Pyrexia']",1,MODERNA,IM 952526,,35.0,F,"Myalgia, Fever, Diarrhea, Tachycardia, chest tightness, SOB, 12/29 After vaccination felt chest tightness, shortness of breath, tingling in her throat, heart racing. She stayed and was monitored for an hour. When she got home she took Benadryl which helped her sleep. She continues to have mild shortness-of-breath today. Her left arm is sore and she has body aches. Her temp is 100.6 today. 12/30 1712: While speaking on the phone with her she is speaking in full sentences without apparent dyspnea. 12/31 had bad night - high fever 101.5 at 0100 overnight last night. This morning feels tired, lethargic, and no appetite. She still has body aches. No fever this morning. 1/4 - employee reports she is doing much better today. She says she had a rough weekend but is much better today. She able to get back to her running usually runs 25 miles/week.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chest discomfort', 'Decreased appetite', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Lethargy', 'Myalgia', 'Pain', 'Pain in extremity', 'Palpitations', 'Pharyngeal paraesthesia', 'Pyrexia', 'Tachycardia']",1,PFIZER\BIONTECH,IM 952527,,42.0,M,left cervical lymph node enlargement,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/11/2020,12/21/2020,10.0,OTH,,,,,,['Lymphadenopathy'],1,PFIZER\BIONTECH,IM 952528,,55.0,F,Rash Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/23/2020,,OTH,,,,,,['Rash'],1,PFIZER\BIONTECH,IM 952529,,59.0,M,"Headache, Myalgia & Fever Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 952537,,33.0,M,"Arthralgia, UrticariaPruritus, NauseaVomiting, stomach cramps Narrative: 12/29 approximately 15 min after vaccination, employee reports onset of ""foggy brain"", stomach cramps, and widespread itching. He was transferred to the ED. Evaluation revealed no rash and the physical exam was normal. He was treated with 50 mg of benadryl PO and observed in the ED for about 90 minutes and discharged back to work. He was given a prescription for hydroxyzine 25 mg po q 6 hours x 5 days. On 12/30 - he reports his arm is sore and he still feels itchy. Now he has some nausea and his joints hurt. He plans to stay home from work to rest today. He had to leave work early yesterday (works night shift). 12/31 - reports he feels better but still has a headache and feels achy. He hasn't taken the hydroxyzine because his itching is not as intense. 1/4 employee reports his symptoms have improved and has mild achiness, fatigue, and itching which he describes as 1-2 on a scale of 1-10.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Abdominal pain upper', 'Arthralgia', 'Feeling abnormal', 'Headache', 'Impaired work ability', 'Nausea', 'Pain', 'Pain in extremity', 'Pruritus', 'Urticaria', 'Vomiting']",1,PFIZER\BIONTECH,IM 952545,,27.0,F,Headache Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/30/2020,2.0,OTH,,,,,,['Headache'],1,MODERNA,IM 952553,,62.0,M,"Angina Upper lip swelling/tickling and tongue tingling Narrative: 61 year old female with HTN and asthma with multiple allergies to meds and prior angioedema in past. Presented for her first dose of COVID19 vaccine; after the injection she felt her upper lip tingling and tongue. NO SOB, no throat symptoms, no change in voice, no rash, no hives. NO N/V. She did have some chest tightness. Diphenhydramine IV, famotidine IV, and methylprednisolone IV one-time doses given in ED with surveillance. Patient recovered, denied previous sxs, and was discharged from ED with a family member. ED physician note documents patient ""will take"" following medications at home (however no outpatient prescriptions found): Benadryl 50 mg po Q8H x 5 days, prednisone 40 mg po daily x 4 days, and famotidine 20 mg po BID x 5 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Angina pectoris', 'Asthma', 'Chest discomfort', 'Hypertension', 'Lip swelling', 'Paraesthesia oral']",1,PFIZER\BIONTECH, 952558,,47.0,F,SkinRash swelling Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Rash', 'Swelling']",1,PFIZER\BIONTECH,IM 952567,,34.0,F,"Headache, Rash, UrticariaPruritus, NauseaVomiting, lethargy Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/29/2020,,OTH,,,,,,"['Headache', 'Lethargy', 'Nausea', 'Pruritus', 'Rash', 'Urticaria', 'Vomiting']",2,MODERNA,IM 952572,,42.0,F,"Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, body aches, fever, HA, joint pain, nausea, chills, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 952581,,52.0,M,CoughWheeze Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/18/2020,2.0,OTH,,,,,,"['Cough', 'Wheezing']",UNK,PFIZER\BIONTECH, 952590,,56.0,F,Headache heartburn/dyspepsia; injection site pain and stiffness of the left arm Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Dyspepsia', 'Headache', 'Injection site pain', 'Musculoskeletal stiffness']",UNK,MODERNA,IM 952598,,24.0,M,"Myalgia, Fever, Chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 952623,,53.0,M,"Myalgia, Fever, freezing head to toe, uncontrollable shaking, 101 degree F temp, sour stomach, body aches, fatigue Narrative: Patient took OTC advil and omeprazole to treat reaction",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Dyspepsia', 'Fatigue', 'Feeling cold', 'Myalgia', 'Pain', 'Pyrexia', 'Tremor']",1,MODERNA,IM 952630,,44.0,F,"Dizziness, Headache, Myalgia, Fever, HA, body ache, chills, 101 degree F fever, sore throat, dizziness Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Chills', 'Dizziness', 'Headache', 'Myalgia', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 952645,,,M,Fever Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/30/2020,,OTH,,,,,,['Pyrexia'],1,MODERNA,IM 952655,,56.0,M,Headache Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,OTH,,,,,,['Headache'],UNK,PFIZER\BIONTECH, 952663,,36.0,F,"Headache, Myalgia, Diarrhea & NauseaVomiting Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Diarrhoea', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 952675,,59.0,F,"Headache, Myalgia, Fever, FATIGUE, CHILLS, ARM PAIN Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 952681,,56.0,M,Headache & Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/30/2020,,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 952688,,38.0,F,"Tingling on right side of face, ""zapping"" sensation, no drooping, no awkward smile, no abnormality with eye Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,OTH,,,,,,['Paraesthesia'],UNK,MODERNA,IM 952696,,24.0,F,Myalgia & Fever Narrative: Fever to 102,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Myalgia', 'Pyrexia']",1,MODERNA,IM 952703,,58.0,F,Dizziness & HYPERtension Narrative: DIZZY; BP 166/90 MM HG; 149/84 MM HG; 150/86 MM HG,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Dizziness', 'Hypertension']",1,MODERNA,IM 952708,,58.0,F,"ErythemaMultiform, UrticariaPruritus, Injection site pain, heat, ulceration Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/29/2020,6.0,OTH,,,,,,"['Erythema multiforme', 'Injection site pain', 'Injection site ulcer', 'Injection site warmth', 'Pruritus', 'Urticaria']",1,MODERNA, 952714,,43.0,F,"Myalgia REDNESS, SWELLING AROUND INJECTION SITE LASTING 48 HOURS, HARD KNOT, INCREASED REDNESS DURING THAT 48 HRS; REDNESS GONE ABOUT 72 HOURS LATER THEN ITCHING STARTED LASTING TO PRESENT DAY; AREA NOW WITH 6X6 INDURATED, CALORIC, ERYTHEMIC AREA TO RIGHT DELTOID Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,OTH,,,,yes,,"['Injection site erythema', 'Injection site induration', 'Injection site nodule', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Myalgia']",1,MODERNA,IM 952725,,46.0,F,Dizziness & Headache Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/30/2020,,OTH,,,,,,"['Dizziness', 'Headache']",1,MODERNA,IM 952726,,42.0,F,"SkinRash & Rash Narrative: Vaccine on 12/22/2020. That evening at 10:30PM, started w/ itching and rash (erythematous) on chest and abdomen. Resolved with Benadryl 50mg.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Pruritus', 'Rash', 'Rash erythematous']",1,PFIZER\BIONTECH,IM 952727,,35.0,M,"Headache shortness of breath, injection site pain Narrative: patient reports shortness of breath resolved with rest; no treatment needed for headache or injection site pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Dyspnoea', 'Headache', 'Injection site pain']",UNK,MODERNA,IM 952728,,52.0,M,"left arm pain, right thigh Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Pain in extremity'],1,MODERNA,IM 954165,MD,21.0,U,"Five (6) vials of Moderna COVID vaccine (NDC:80777-0273-99 (5010700) Lot #011J20A) that was supposed to contain (10) doses per vial contained only (9) doses. (Medical Group) received 250, 5ML (10) dose vials in a shipment received 12/22/2020. At onset of vaccinations, the immunizations Clinic noted five of the vials did not contain the appropriate amount of vaccine as stated per the manufacturer. No adverse impact. No mission degradation. PQDR is submitted to address this discrepancy on current and future vaccine shipments.",Not Reported,,Not Reported,Not Reported,,Not Reported,,,12/23/2020,,UNK,,,,,,"['Manufacturing product shipping issue', 'No adverse event', 'Product packaging quantity issue']",UNK,MODERNA, 927357,CA,28.0,F,Hives-like appearance on both arms within 10 minutes of administering vaccine. Resolved by itself in 30-40 minutes.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,None,None,None,,None,['Urticaria'],1,MODERNA,IM 927358,CA,34.0,F,"45 min later after receiving the vaccine I felt a lump in my throat. No other symptoms of an allergic reaction. Took benadryl with improvement of symptoms. Had intermittent difficulties swallowing seven hours afterwards. Went to the ED and was prescribed prednisone/ pepcid/benadryl. Symptoms improved but next day felt intermittent difficulty swallowing again. Returned to the ED and was given IV solumedrol and, IV pepdcid, IV benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/27/2020,26.0,PVT,Synthroid,No,Hypothyroidism,,No,"['Dysphagia', 'Sensation of foreign body']",1,PFIZER\BIONTECH,IM 927359,AR,31.0,F,"Patient alerted pharmacist to feeling light headed at 12:10pm. Patient was instructed to sit down on the floor. She stated she felt hot and hadn't eaten all day. She was given a few bites of apple sauce and some Dr. Pepper to drink in case of low blood sugar. She was also given 25mg of diphenhydramine in case of an allergic reaction after the vaccine adminstration at 12:15pm. A few minutes later, she began shaking and stated she thought she was having an anxiety attack. At this time, the patient requested we call 911 because that would make her feel better and so we did.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PHM,Omeprazole 20mg Escitalopram 20mg Lamotrigine 25mg,,,,Azithromycin; brompheniramine-PE-codeine; hydromorphone; metronidazole,"['Anxiety', 'Dizziness', 'Feeling hot', 'Tremor']",1,PFIZER\BIONTECH,IM 927360,TX,21.0,M,"Symptoms started during bedtime and woke me up. Began with severe full body chills and full body muscle shaking and weakness during the night of 1/5 and early morning of 1/6, around 1000 to 0200. Slight headache began during that time as well. Upon waking at 0900 on 1/6, chills and shaking decreased to mild severity, muscles still felt moderately weak and shaky, headache had increased in severity to a severe throbbing pain that worsened upon standing and walking, and moderate visual photosensitivity began. The headache persisted until I took 2 tablets of ibuprofen 200 mg, which is when the severity decreased to moderate after a few hours and then mild by bedtime. The photosensitivity persisted through the day and did not decrease much by bedtime. Upon waking 1/7, there was only a mild headache and mild photosensitivity that faded completely within a few hours, no medication required. No more symptoms in the afternoon.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,"All topical skin medications for eczema, acne: Hydrocortisone butyrate ointment 0.1% Tacrolimus ointment 0.1% Pimecrolimus cream (Elidel) 1% Clindamycin phosphate and tretinoin gel 1.2%/0.025%",None,Eczema,,None,"['Chills', 'Headache', 'Muscular weakness', 'Pain', 'Photosensitivity reaction', 'Tremor']",2,PFIZER\BIONTECH,IM 927361,AZ,61.0,F,Moderna covid 19 vaccine EAU,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Celebrex, estradiol, paxil, abilify, losartan, metformin, norco, morphine, phentermine, klonipin, modafinial, calcium, b complex, stool softener",None,"Diabetes, back pain, high cholesterol, obesity, depression, anxiety",,"Ceftin, clindamycin, vancomycin, augmentin, ativan,",['Unevaluable event'],UNK,MODERNA, 927362,FL,36.0,F,"2 hrs after vaccine felt sweating, clammy. Gas pains and cramps began. Loose stool once. 7 pm arm was sore and throbbing 6 of 10, injection site flushed and warm to the touch 9pm pain worsened to 8of 10. Unable to grab toothbrush with left arm sharp pain 10 of 10. Unable to sleep on left side due to pain and pressure . 6:00 am Thursday pain worse and unable to lift arm above the shoulder. Was unable to drive with left hand. All day today bad gas and abdominal cramps.by the end of the work day I was unable to hold anything in my left hand, body aches started, legs tight and achy. Frontal headache. Took Tylenol extra strength q 6 hrs, nsaid 800mg bid. And aleve, no relief",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,None,No,No ( hormones low) Dx with covid 7/2020,,PCn,"['Abdominal pain', 'Cold sweat', 'Diarrhoea', 'Flatulence', 'Headache', 'Hyperhidrosis', 'Injected limb mobility decreased', 'Injection site erythema', 'Injection site warmth', 'Muscle tightness', 'Pain', 'Pain in extremity', 'Sleep disorder']",1,MODERNA,IM 927363,CA,26.0,F,Had chills fever and body ache starting 01/07/21 Temperature went as high as 102.0 took ibuprofen and came down 97.9,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,OTH,Insulin,Diabetes,Diabetes,,None,"['Chills', 'Pain', 'Pyrexia']",1,MODERNA,IM 927364,TX,43.0,F,"On day 7, a red rash appeared just below the injection site and is indurated, hot, and tender. It spread in size within the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,"Zyrtec, spironolactone, fluticasone, valacyclovir",None,None,,Sulfa drugs,"['Induration', 'Rash erythematous', 'Skin warm', 'Tenderness']",1,MODERNA,IM 927365,,24.0,F,"Morning 8 days after injection, emergence of rash above injection site and redness and swelling at injection site. Morning 9 days after injection rash became a larger hive and doubled regular Zyrtec dosage. Morning 10 days after injection symptoms gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,UNK,"Zyrtec, Sronyx, Zoloft",N/a,N/a,,Minocycline,"['Injection site erythema', 'Injection site swelling', 'Rash', 'Urticaria']",1,MODERNA,SYR 927367,MO,60.0,F,"Tire on day one-slept for 18 hours. Day 2: Woke up and was mildly achy, not wanting to do anything and red large swelling in my right deltoid. Very tender. Also, edema starting in my right axilla extending down my lateral chest about 7"". Day 3 to 7: Achiness is gone. Edema and swelling continue. Eventually the red swollen area became itchy. The edema under my arm (not a lymph node) was tender when my arm was close to my body. Woke me up during the night frequently. Very hard to sleep.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,Naproxen and Benadryl,none,hypothyroidism,"Influenza- site tenderness, Pain and weakness adducting arm",Nickel,"['Fatigue', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Insomnia', 'Oedema', 'Pain']",1,MODERNA,IM 927368,CT,27.0,F,"Initially had (unconcerning) soreness/pain at the injection site hours 6 through ~60 after the vaccination. Soreness completely resolved after hour 60 then on day 7 post vaccination my arm began to feel tender again. Day 8 post vaccination it is painful at the injection site and the pain is only moderate but somewhat limiting. I have no other sx and did not injure or over-use my muscle. I don?t intend to take any medication for the discomfort. There is no redness/swelling at the site, just pain like there was immediately following the vaccine. I stopped getting VSAFE check ins after my third day of no symptoms which is why i?m completing this form.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,pre natal vitamins (been taking since 2017) vitamin D3 (been taking since 2018),none,none,"age 21, hepatitis B booster, syncope - possible vasovagal episode? never reported. never had that occur with other vaccinations",none,['Injection site pain'],1,MODERNA,IM 927369,CA,45.0,F,"I got the vaccine on 12/18/20 on my left arm and on 12/28/20, 10 days after I started to have pain on my upper left arm and the next day the pain went to my armpit, back and forth from my upper left arm to my armpit and this went on for at least 5 days. On 01/02/21, 15 days after I notice red bumps on my upper left arm and as days went on red bumps show in my armpit, left back, and chest. The pain went from sharp to burning. On 01/06/21 I got the 2nd dose of the vaccine and I told the injection person about the red bumps. I told him that they look like hives. He spoke with the medical doctor about it and doctor said it was ok for me to get the 2nd dose of the vaccine. They think it was a delayed reaction. They have me monitored for 30 mins after the 2nd dose of the injection before I leave the site. I still have pain and red bumps so I went to see my primary doctor on 01/07/21. The doctor said that I have shingles. I told him that I never had shingles before and he said maybe the vaccine trigger it. He prescribed me some medications for the shingles. I don?t know if the vaccine trigger the shingles or just coincidence but I want to report this maybe someone might have the same experience. Thank you.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,01/02/2021,15.0,WRK,Vitamin,No,No,,No,"['Axillary pain', 'Herpes zoster', 'Pain in extremity', 'Rash erythematous']",1,PFIZER\BIONTECH,SYR 927370,IN,27.0,F,"Arm soreness at injection site began a few hours after injection. About 18 hours after vaccine was given, experienced body aches, and tingling/numbness in arm that had injection and legs. Around this time also felt a little dizzy/light-headed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,"Keppra, Minocycline",,Epilepsy,,,"['Dizziness', 'Hypoaesthesia', 'Injection site pain', 'Pain', 'Paraesthesia']",UNK,MODERNA,IM 927371,VT,50.0,F,"Left arm, shoulder and neck swelling and severe pain for 9 days. On day 9, area vaccinated swelling (lump) and draining (weeping).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,"Melatonin 6mg, D3-2,000iu, omeprazol, Vitamin C 500 mg, aspirin.","Trigeminal Neuralgia, hemicrania continua, obesity, asthma, Crohn's,",Same,,"Shrimp, sulfa drugs, codeine, phenegran, gabapentin, molds, dust.","['Arthralgia', 'Injection site extravasation', 'Injection site swelling', 'Neck pain', 'Pain in extremity', 'Peripheral swelling', 'Swelling']",UNK,MODERNA, 927372,CA,79.0,M,"Vertigo, elevated BP",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/04/2021,6.0,OTH,"nortriptyline, tamsulosin, advair",,"COPD, IBS",,sesame,"['Blood pressure increased', 'Vertigo']",1,MODERNA,IM 927373,IN,27.0,F,"Approximately 24 hours after receiving dose 1 of the Pfizer vaccine, I began having chills and vomited. My fatigue became more severe as well. Later that evening my fatigue persisted and I noticed a rapid heart rate via my Watch. My resting heart rate which usually is about 80 BPM was at 100 while laying down and not engaged in any physical activity. When I stood I was dizzy and had poor balance. While my entire arm no longer hurt, the injection site showed a bump as well. When I awoke the next day my heart rate appeared normal again, and I wasn't especially fatigued compared to before I got the vaccine. I did experience another minor gastro-intestinal episode later that afternoon, but otherwise my symptoms appeared to have passed aside from the fatigue. By the end of my work day I was very tired again, although it is uncertain if this is due to the vaccine or from my continued recovery from Covid and adjusting to the physical demands of going back to my job in-person. Because I received my vaccine on the same day as my first day back to work, I have no experience working post-covid before having the vaccine to compare my current state of fatigue to. On the evening of 01/07 I noted that fatigue was slightly less pronounced. I do not currently have a primary care doctor but will be calling to try to gain an appointment so that my second dose can be monitored.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"Junel FE birth control, 1.5. 1 tablet daily. Vitamin D3 5000 IU daily.",Tested positive for Covid-19 on 12/19/2020.,Congenital eye disorders including Sclerocornea and glaucoma. Obesity. History of adrenal insufficiency with cortisol dependence in childhood with continued monitoring. Genetic abnormality treated similarly to Turner Syndrome.,,Seasonal alergies. Treated well with Zyrtec OTC. Reacted negatively in the past to valium.,"['Balance disorder', 'Chills', 'Dizziness', 'Fatigue', 'Gastrointestinal disorder', 'Heart rate increased', 'Injection site mass', 'Vomiting']",1,PFIZER\BIONTECH, 927374,TX,39.0,F,"8th day post vaccination, injection site is red, indurated, warm To touch and itchy. Mild discomfort associated with symptoms (4/10 on pain scale)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"Lansoprazole otc, np thyroid, iron + vit C. Spironolactone, sprintec. Vit D. B12 ODT. Aspirin 81mg",,Hypothyroidism,,NKFDA,"['Discomfort', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 927375,WA,34.0,M,"Light-headedness, dizziness, headache. Feelings of being cold/hot with high lability. Facial pressure. Exacerbating throughout the day and continuing into the following day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,None,None,None,,None,"['Affect lability', 'Dizziness', 'Facial discomfort', 'Feeling cold', 'Feeling hot', 'Headache']",2,PFIZER\BIONTECH,IM 927376,IN,36.0,F,"Fatigue, tired, muscle weakness, trouble breathing, pain in site of injection, clouded mind",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/01/2021,,PVT,Potassium citrate Probiotics Muiltvitamims Magnesium,None,IBS Asthma Allergies,,Milk Penicillin Trees Mold,"['Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Injection site pain', 'Muscular weakness']",1,PFIZER\BIONTECH,IM 927377,WA,59.0,F,"Left thigh: reddened circle around injection site, 4 inches in diameter. Skin appears blanched around the outside border of the reddened area .",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/06/2021,6.0,PVT,Multi B complex vitamin Letrozole 2.5mg Pepcid 20mg Melatonin 6mg,none,"Hx: breast cancer, mastectomy with reconstruction 2017",Muscle weakness in deltoid with Shingrix x 4 months,none,"['Injection site erythema', 'Pallor']",1,MODERNA,IM 927378,CO,39.0,F,"Moderna COVID?19 Vaccine EUA Premedicated with benadryl and phenergan prior to injection. No pain at time of injection. 2.5 hours later, arm started to be sore at site, fever of 101.4, diarrhea x 1 episode. Went outside and fresh air helped, felt much better. Fatigue and very mild body aches, arm soreness (no more than flu shot, less than tetanus) . 630pm: Acid reflux was the worst side effect I experienced. I asked a co-worker who received the same vaccine the day prior to me. She also had bad reflux. Even with a history of GERD, I do not need to take PPI's any longer and I needed to take an omeprazole the night of my vaccine, which helped some. Took tylenol 500mg and went to bed. Woke up today (the following day after vaccine feeling normal with arm soreness which got better throughout the day. I would describe my symptoms as mild. The MD I work with said I should report these to Moderna just so they can track all symptoms that people are experiencing post vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,UNK,"Phenergan, Imitrex, Melatonin, Vitamin D, Vitamin C, Zinc, Benadryl","mild cold started 4 days prior to vaccine and ended 1 day prior to vaccine (sneezing, runny nose, negative covid19 PCR test)",Chronic Migraines HPV w/cervical dysplasia GERD Vit D deficiency Iron deficiency anemia,"Flu vaccine around 30 years old when someone put the vaccine into my bursa. Arm pain, redness and swelling of entire upper arm ","Penicillin, Amoxicillin, Demerol, Nortriptyline","['Diarrhoea', 'Fatigue', 'Gastrooesophageal reflux disease', 'Injection site pain', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 927379,TX,36.0,F,"Rash that began on vaccinated arm 24hrs later and spread to entire body lasting 48 hours. Took Benadryl for 2 days to combat symptoms. Then on 01/07/2021 a week after receiving the vaccine a large hot welt developed randomly at the vaccine site, temp of the welt was 104 degrees but body temperature was normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PVT,NONE,NONE,NONE,,NONE,"['Injection site mass', 'Injection site warmth', 'Rash']",1,MODERNA,IM 927380,UT,54.0,F,"Extreme fatigue, swollen lymph node near collarbone, nausea on day two post second vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,UNK,Estradiol and amlodipine,,Hypertension,,Penicillin,"['Fatigue', 'Lymphadenopathy', 'Nausea']",UNK,PFIZER\BIONTECH,IM 927381,MD,53.0,F,Muscle cramping worse in both legs (anterior thighs and calf?s) also hands and arms. No treatment,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,MIL,Losartan 100mgs daily - pm Verapamil 240mgs daily - am Claritin 10mgs daily- am Prilosec 40mgs daily - pm Vitamin D 1000u daily- am Multivitamin 1 tablet daily - am Biotin 600mgs Daily - pm Diclofenac 75mgs Daily- am Naproxen 2 tablets Dai,None,"HTN. GERD, Seasonal Allergies, Pancytopenia, Scoliosis, DDD",,Lisinopril- cough HCTZ- hydrochlorithiazide - palpitations,['Muscle spasms'],1,MODERNA,SYR 927382,AL,45.0,F,"Extreme soreness and stiffening to left shoulder, which continues as of now. Nausea lasting only hours later that evening.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,65 mg iron,None,None,,Sulfa Meds,"['Arthralgia', 'Musculoskeletal stiffness', 'Nausea']",1,MODERNA,IM 927384,,30.0,M,"12-24 hours after vaccination: high fever 102+, chills, nausea, fatigue, headache, arm occasionally twitching near injection site, very sore arm, irritability",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,UNK,none,none,none,,NKA,"['Chills', 'Fatigue', 'Headache', 'Irritability', 'Muscle twitching', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 927385,OR,26.0,F,"-non-raised, non-itchy, red rash on and around site of injection (asymmetrical). warm to touch. blanching. no pain. nsometimes soreness. no other notable skin changes on arm. onset 1/7/2021, 8 days after injection. noticed around 18:30. has not significantly spread at time of submitting vaers (22:20). - no treatment at this time. monitoring. -arm soreness, onset day 1 after injection until day 4 after injection. no treatment. transient, resolved day 4",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,lorazepam prn. multivitamin. vitamin c prn.,none,"anxiety, depression","trumenba, 2017, age 23 - severe chills, fatigue, sweats following vaccine in left arm; soreness. resolved after 1-2 days.",nkda,"['Injection site rash', 'Injection site warmth', 'Pallor']",1,MODERNA,IM 927386,TX,31.0,F,"Redness, swelling, itching, burning within first 24 hours. Very painful large red hive like welp with big knot that progressed the first 24 hours. Redness hot to the touch. Headache for 12-14 hours beginning 6-7 hours post injection. Body aches & chills, no fever during first 12 hours. Extra strength Tylenol did lessen symptoms (pain, aches, chills but not swelling or redness). 48 hours after injection: became very itchy, still firm knot at site with redness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PHM,"Methylphenidate 20mg, Propranolol ER 60mg, daily Prenatal w/ DHA/EPA, Omeprazole 20mg.",No illnesses prior.,Endometriosis.,,Sulfa allergy.,"['Burning sensation', 'Chills', 'Erythema', 'Headache', 'Pain', 'Pruritus', 'Swelling', 'Urticaria']",1,MODERNA,SYR 927387,,46.0,M,"7/10 arm soreness, radiating pain to neck/temporal lobe on same side as shot. Duration of 1.5 days. No pain meds necessary.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,UNK,"Otc dietary supplements (folate, zinc, magnesium, selenium, multivitamin)",Minor seasonal allergies,None,,None,"['Headache', 'Neck pain', 'Pain', 'Pain in extremity']",1,MODERNA, 927388,WI,26.0,F,"Headache, muscle pain, minor neck stiffness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,,,Hypothyroidism,,,"['Headache', 'Musculoskeletal stiffness', 'Myalgia']",1,MODERNA,IM 927390,CA,56.0,F,Injection site is swollen and red and looks like I was stung by a bee,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,"Adderall XR15, Synthroid 50 MCG","Reactive hypoglycemia, Hashimoto?s thyroiditis. -AB blood type.",None,,None,"['Injection site erythema', 'Injection site swelling']",UNK,MODERNA, 927391,CA,29.0,F,I was administered 5 times the recommended dose. At this time I am not experiencing any adverse effects to the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,SEN,None,None,None,,None,"['Incorrect dose administered', 'No adverse event']",1,PFIZER\BIONTECH,IM 927392,WA,56.0,M,"Severe chills, fatigue, shivering. Unable to do daily activities. Symptoms started 5 days after the COVID vaccine and have lasted for 7 days so far.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/31/2020,5.0,OTH,None,None,High blood pressure Obesity,,None,"['Chills', 'Fatigue', 'Loss of personal independence in daily activities', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,SYR 927393,HI,52.0,F,Injection site pain Muscle pain Headache Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Metformin Januvia Lisinopril Metoprolol Atoravastatin Singulair Lyrica Low dose aspirin Tizanidine Trazadone,,Diabetes Asthma Heart disease High Cholesterol,,Shellfish Iodine Vicodin Steroids,"['Fatigue', 'Headache', 'Injection site pain', 'Myalgia']",1,PFIZER\BIONTECH,SYR 927395,,37.0,M,"Fatigue, congestion",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,MIL,,,,,,"['Fatigue', 'Nasal congestion']",1,MODERNA,SYR 927396,NC,63.0,F,"20 mins after receiving vaccine, sensation of ""wave"" through brain with almost loss of consciousness. BP 151/93, 10 minutes later BP 130/83. Severe Dizziness and intense anxiety attacks commenced within 24 hours and lasted for 7-8 days. These were accompanied by sensation of pressure in brain and headache. Treatment with hydroxyzine 25mg once or twice a day reduced intensity of anxiety attacks but did nothing to help with the dizziness. Headaches were intermittent during this period. Almost all dizziness subsided by day 12 post vaccine. Headaches subsided by day 5.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,OTH,"Fexofenadine, Vit D, synthroid, Piroxicam",,EDS (Ehlers Danlos Syndrome),,"sulfa , tropical fruits,","['Anxiety', 'Blood pressure increased', 'Dizziness', 'Feeling abnormal', 'Head discomfort', 'Headache']",1,PFIZER\BIONTECH,IM 927397,KY,25.0,M,"Fever and chills beginning day of vaccination, resolved 3 days post-vaccination. No treatment required.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Pyrexia']",1,MODERNA,IM 927398,CA,60.0,M,"shoulder pain, shoulder swelling, right axillary adenopathy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Arthralgia', 'Lymphadenopathy', 'Swelling']",1,MODERNA,IM 927399,CA,1.5,M,"on the next day after the vaccine, he began to have a fever up to. 102 Fahrenheit rash spreads to this day throughout the body with itching, the child also has strange behavior, fatigue. the attending physician denies us an appointment and tells us to call 911.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/18/2020,1.0,PVT,tylenol,covid-19,no,,no,"['Abnormal behaviour', 'Fatigue', 'Pruritus', 'Pyrexia', 'Rash']",UNK,MERCK & CO. INC.,IM 927400,CT,37.0,M,Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Allopurinol Colchicine,,Gout,,NKA,['Pyrexia'],2,PFIZER\BIONTECH,IM 927401,FL,67.0,F,"Almost 18 hours after the injection, my arm was painful, I began to run a fever above 102 degrees, I was so achey, I had to get help to get off the commode. It hurt to roll over in bed. I lost my taste and smell. It lasted approximately 24 hours. I had Covid in June, 2020 and had all of the exact symptoms, 100 times worse than when I had Covid. 9 days later, I had fever above 102 again, chills, shaking for approximately 6 hours again. Is this a normal reaction?",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/29/2020,28.0,WRK,"Ibuprofen, Omega 3, Vitamin D3, Modafinil, Celexa",none,"Past medical history of Stage 1 Breast Cancer, treated with lumpectomy and radiation.",,Sulfa,"['Ageusia', 'Anosmia', 'Chills', 'Pain', 'Pain in extremity', 'Pyrexia', 'Tremor']",1,MODERNA,IM 927402,MD,55.0,F,By the evening pounding headache not relieved by Tylenol. Body hurts nausea still dizziness restless,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/07/2021,6.0,PVT,Multi-vitamin fish oil. Calcium st john wort dhea,None. 9 days after first vaccine I experienced dizziness and nausea but thought I had vertigo. Then received second vaccine this morning and by the evening I felt awful,None,,None,"['Dizziness', 'Headache', 'Nausea', 'Pain', 'Restlessness']",3,PFIZER\BIONTECH,IM 927403,NY,65.0,F,"Approximately 20 to 30 minutes after receiving the vaccine, I had what appeared to be a seasonal allergic reaction, in which I could not stop sneezing and my eye tearing. This continued throughout the evening and night but not as intense as when it first began. I awoke at 1:00 AM to a very intense sneezing and eye tearing, but on only the left side of my face and eventually both sides. I took Allegra D and did get relief. The sneezing (allergic rhinitis) reaction continued but after almost an hour of taking the Allegra D , it was not as intense. My face also appeared swollen but only with respect of atypical allergic rhinitis intense reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,"Dexilant; Losartan Potassium, Eliquis, Zrytec",,,,Sulfa,"['Lacrimation increased', 'Sneezing', 'Swelling face']",1,MODERNA,IM 927404,WI,44.0,F,"Injection site pain for 72 hours post injection (Dec 30-Jan 2) At injection site a raised red hard swelling 6cm round, very itchy. First noticed Jan 6 and is beginning to recede, but is still present.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,SEN,None,Seasonal allergies,"Seasonal allergies, arthritis",,"Cow milk products, soy, corn","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA,IM 927405,OH,39.0,F,Red circle with raised edges at site of injection. Area continues to be slightly red. No other symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/04/2021,11.0,PVT,,,,,,"['Injection site erythema', 'Injection site rash']",1,MODERNA,IM 927406,TX,59.0,F,"Rash with itching. 01/04/2021 prednisone 60mg, 40mg, 20mg-3 day taper.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/26/2020,5.0,PVT,"lotensin, carvedilol, spironolactone, hydralazine, synthroid, famotidine, Vit D-3, Vit C, Magnesium, Turmeric, Acetaminophen, Ibuprofen, Tramadol, Melatonin, Gabapentin, Methocarbamol",,"Hypothyroidism, HTN, obesity and herniated lumbar disc with chronic back pain.",,HCTZ-dizziness and ears ringing. Hydrocodone-itching. Demerol-shortness of breath.,['Rash pruritic'],1,PFIZER\BIONTECH,IM 927407,CA,63.0,F,"2 days after vaccination had fever of 101.5, sore throat, and felt achy",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/04/2021,2.0,PVT,unknown,none known,positive COVID 10/4/2020,,unknown,"['Oropharyngeal pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 927408,CO,47.0,F,"Chills, body & joint aches, headache, fatigue, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,WRK,"gabapentin, tylenol",no,peripheral neuropathy,,none,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Malaise', 'Pain']",1,PFIZER\BIONTECH,IM 927409,CA,48.0,F,"Fever/chills, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PVT,,unknown,COVID 11/1/2020,,unknown,"['Chills', 'Nausea', 'Pyrexia']",1,MODERNA,IM 927410,FL,28.0,F,"I received the COVID 19, vaccine January 7, 2021. Around 12:30 AM on January 8 I felt nauseous, was very clammy and ending up fainting. I will be calling out my primary due to this issue. I still need a second dose and unsure if I should get one now.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,None,None,Seasonal allergies,,"Ibuprofen, Benadryl","['Cold sweat', 'Nausea', 'Syncope']",2,MODERNA,IM 927411,MI,60.0,F,"Severe headache one hour after injection. Followed by nausea, chills, muscle aches and fever of 101.5",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"Losartan, Amlodipine, Bentyl",None,Hypertension Irritable bowel syndrome,,"Shrimp , Spinach, Diovan, Metoprolol, Penicillin, Keflex, Z-pack","['Chills', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",UNK,MODERNA,SYR 927412,OK,56.0,F,"Fever 102.9, chills, body aches, pain at injection site, nausea, cough",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,None,No,Hypothyroidism Sjogrens Rheumatoid arthritis,,Morphine Penicillin Phenergan,"['Chills', 'Cough', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 927414,CA,49.0,F,"Shot almost unnoticeable at time of injection and no discomfort on first day. Arm a little sore on second and third day. On by the fourth day arm was become uncomfortable with red raises area around injection site warm to the touch and lymph node involvement. Arm and lymph node pain have continued to progress. Red raised area about 3"" diameter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,PVT,unknown,unknown,unknown,,unknown,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Lymph node pain', 'Pain in extremity']",1,MODERNA,IM 927415,CT,28.0,M,4 days later after the vaccine my left eye turned really red with crust and mucus coming out. I went to walk in clinic and was being treated for pink eye. I was started on an antibiotic eye drop. A day later my right eye started to have the same problem. I scheduled an appt with a eye specialist where he examined both eyes and said I had a major infection. I was started on steroid eye drops which I am still taking but seems my eyes are not getting better. I have a follow up with another specialist next week for further testing. I have been out of work due to this matter.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,WRK,One a day vitamin Allegra D Vitamin C Flonase nasal spray,,,,Cough medicine- Delsyum,"['Conjunctivitis', 'Culture', 'Eye discharge', 'Eye infection', 'Eyelid margin crusting', 'Impaired work ability', 'Ocular hyperaemia', 'Ophthalmological examination']",2,MODERNA, 927416,,48.0,M,Persistent fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/19/2020,1.0,MIL,,,,,,['Fatigue'],1,PFIZER\BIONTECH,IM 927417,VA,56.0,F,"Chills, fever, nausea, vomitting, diarrhea, and body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/08/2021,7.0,OTH,"Vitamin D, Magnesium, probiotics, calcium, Hair skin and nails. Zyrtec",None,Controlled atrial fibrillation,,"codeine, benadryl, coumadin","['Chills', 'Diarrhoea', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 927418,TX,51.0,F,"one week after 1st round, 1/4/21, area where vaccinated was swollen, itchy, red and emanating heat",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,OTH,none,none,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 927419,,58.0,F,"Jan 5, 2021 - Fatigue, nausea, diarrhea, headache, unable to get out of bed. Sore arm. Jan 6, 2021 - Very dizzy, nausea, headache. Seen at clinic. Blood pressure elevated. Normal heart rate. Prescribed extra dose of Lisinopril for the high blood pressure and Zofran for the nausea. Sore arm. Jan 7, 2021 - Fatigued, no longer dizzy but feeling lightheaded. Mild headache, mild nausea. Arm pain resolved. Jan 8, 20214 - All symptoms resolved except for mild to moderate fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,MIL,"Lisinopril, Vit D, Calcium, Albuterol rescue inhaler",None,Hypertension - well controlled. Asthma & Allergies - well controlled,,"Bactrim, Compazine,Piroxicam, Latex, Gluten, Sorbitol PIROXICAM 2. MASTISOL ADHESIVE (GUM MASTIC/STORAX/METHYL SALICYLATE/ALCOHOL) Reactions: RASH 3. TINCTURE OF BENZOIN (BENZOIN) Reactions: RASH 4. OTHER Comment: LATEX, GLUTEN 5. FLOMAX (TAMSULOSIN) 6. COMPAZINE (PROCHLORPERAZINE) 7. FRUCTOSE 8. SORBITOL 9. LACTOSE","['Blood pressure increased', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pain in extremity']",UNK,MODERNA,IM 927420,VA,43.0,F,"Fever 101, body aches, severe headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/07/2021,6.0,PVT,Seroquel 25 mg daily Lexapro 30 mg daily clonazepam 0.5 mg prn Vitamin d daily Famotidine 40 mg daily Zyrtec 10 mg daily Meloxicam daily,None,"Depression, anxiety, high blood pressure, acid reflux",,None,"['Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 927421,PR,59.0,F,"HEADACHE STARTED1/7/2021 STARTED1/8/2021 WITH FACIAL AND NASAL REDNESS, PRURITUS NO SOB WAS TOLD TO TAKE BENADRYL 50MGS STAT AND IF WORSENS WILL GO TO ER",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,"SYNTHROID,TYLENOL, BENADRYL,CARDEZARTAN,HCTZ, METFORMIN",DENIED,"HTN, HYPOTHRYROIDISM,THRYOID CA, DM, FIBROMYALGIA, ARTHRITIS , GASTRITIS",,SULFA IODIDE SHELLFISH,"['Erythema', 'Headache', 'Pruritus']",2,PFIZER\BIONTECH,IM 927422,GA,39.0,M,"12 hours after injection - arm in severe pain, severe headaches, fever, body aches, chills, generalized joint pains",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Multivitamin,Possible COVID-19,None,,None,"['Arthralgia', 'Chills', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 927423,OH,37.0,M,"Cold chills, body aches, headache about 8 hours after the vaccinne was administered. Symptoms subsided 20 hours later. At around 6:30 the following day the chills came back for about 8 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Monolucast.,,,,,"['Chills', 'Headache', 'Pain']",1,MODERNA,SYR 927424,OH,46.0,F,"Fever 12 hours after covid vaccine. Temp of 103.4 at highest. General fatigue, shivering and sweats.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Entivyo infusion every 8 weeks,Chronic Ulcerative Colitis,Ulcerative Colitis,,,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Pyrexia']",1,MODERNA,IM 927425,FL,48.0,F,"about 7-8 mins after getting injection, I felt faint (put myself on floor because I knew I was going down if I didn't) cold clammy, nauseated, BP dropped, HR wnl, After about 20 mins, I felt fine. Went to work, did develop a migraine afterwards, some body ache and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,birth control loloestrin,none,none,,none,"['Blood pressure decreased', 'Cold sweat', 'Dizziness', 'Fatigue', 'Feeling cold', 'Migraine', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,IM 927426,,60.0,F,"Chest pain Abdominal pain Fever, severe chills, diaphoresis Seizure like activity for two night",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Abdominal pain', 'Chest pain', 'Chills', 'Hyperhidrosis', 'Seizure like phenomena']",2,PFIZER\BIONTECH,IM 927427,VT,55.0,F,"Sudden onset severe diarrhea, accompanied by nausea (no vomiting), chills, severe fatigue, and diffuse rash over LE initially, then to UE. No rash on trunk. Diarrhea resoled in 4 hours after 3 doses of Imodium. Remained afebrile. Benadryl 25mg taken that night, and the next night as rash continued to be itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/28/2020,1.0,WRK,Took 1 ibuprofen directly after having vaccine,none,asthma,,severe tree nut allergy with h/o anaphylaxis,"['Chills', 'Diarrhoea', 'Fatigue', 'Nausea', 'Rash', 'Rash pruritic']",1,MODERNA,IM 927428,GA,78.0,F,"Nausea, chills, constipation",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,OTH,"Clarinet,Synthroid, Rouvasstatin,Singulair, Trokendi, all daily. Prolix twice a year.","Covid, diagnosed 12 December, light case.",None,,Chocolate,"['Chills', 'Constipation', 'Nausea']",UNK,MODERNA,IM 927429,FL,70.0,F,"She verbalize she develop headache, nausea, dizziness. She was evaluated onsite by Rescue and released home feeling better at 10:25 am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,None,None,None,,to eye drops,"['Dizziness', 'Headache', 'Nausea']",1,PFIZER\BIONTECH,SYR 927430,MN,40.0,F,Headache started at 1pm and was gone by 7:30pm Very sore arm Then the nausea and diarrhea started and lasted until 5am Then chills started from 3:00am until 7:00am Then fatigue continued throughout the day- I slept for 15hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,None,Rash on face,None,,Morphine: hallucinations,"['Diarrhoea', 'Fatigue', 'Headache', 'Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 927431,,37.0,M,"7 hours after first COVID-19 dose he experienced dysosmia x 1 hour which spontaneously resolved (not a/w dyspnea, cough, fever, lost of taste, nausea, or vomiting). He did not seek medical attention.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/18/2020,0.0,MIL,,,,,,['Parosmia'],1,PFIZER\BIONTECH,IM 927452,FL,,U,"hearing loss; other zoster-related conditions; other zoster-related conditions; Information has been received on 04-JAN-2021 from a lawyer regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On unknown dates, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by healthcare providers at hearing aid centers for hearing loss and other zoster-related conditions. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of hearing loss and other zoster-related conditions to be related to zoster vaccine live (ZOSTAVAX). Upon internal evaluation, the event of hearing loss was determined to be medically significant.",Not Reported,,Not Reported,Yes,,Not Reported,N,,,,PHM,,,,,,['Deafness'],UNK,MERCK & CO. INC.,OT 927453,TX,67.0,U,"vision loss; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a currently 74-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about an unknown date in 2014, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) by a pharmacist at the pharmacy, for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient was treated by a healthcare provider for the following injury resulting from the patient's zoster vaccine live (ZOSTAVAX) use: vision loss. The outcome of vision loss was not provided. The reporter considered the event of vision loss to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of vision loss was considered to be medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PHM,,,,,,['Blindness'],UNK,MERCK & CO. INC.,OT 927454,NC,,M,"shingles; death; This spontaneous report was received from a lawyer concerning a case in litigation and refers to a 80 year old male patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On or about 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions. On an unknown date (reported as ""subsequent to vaccination""), the patient experienced shingles and was treated with unspecified medications. On 07-JUN-2016, the patient died. The caused of death and if an autopsy was performed were not reported. The outcome of shingles was unknown. The reporter considered death and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).",Yes,06/07/2016,Not Reported,Not Reported,,Not Reported,N,,06/07/2016,,UNK,,,,,,"['Death', 'Herpes zoster']",UNK,MERCK & CO. INC., 927458,CO,,F,"Anaphylactic reaction; This case was reported by a consumer via call center representative and described the occurrence of anaphylactic reaction in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and PNEUMONIA VACCINE. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown. The reporter considered the anaphylactic reaction to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The reporter did not have Lot number or expiry date or brand name of flu shot. The patient had anaphylactic reactions to flu and pneumonia shots. The reporter considered the anaphylactic reaction to be related to PNEUMONIA VACCINE. The reporter did not consent to follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Anaphylactic reaction'],UNK,UNKNOWN MANUFACTURER, 927459,VA,,U,"Syringe leaked of suspension: less than 0.5 given to patient; Syringe leaked of suspension: less than 0.5 given to patient; A report was received from a nurse concerning a patient of unreported age who was participating in the mRNA-1273 Emergency Use Program and experienced syringe leaked of suspension: less than 0.5 given to patient. The patient's medical history was not provided. No concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 on 22 Dec 2020. On 22 Dec 2020, while administering the first of the two planned doses of mRNA-1273 to the patient, some of the suspension dripped out of the syringe. The nurse was not aware of how much leaked out. She stated it was a dribble. Action taken with mRNA-1273 in response to the event was not applicable. The outcome for the event, experienced syringe leaked of suspension: less than 0.5 given to patient, was considered resolved on 22 Dec 2020. The reporter did not provide an assessment for the event, experienced syringe leaked of suspension: less than 0.5 given to patient.; Reporter's Comments: This case concerns a patient of unreported age and sex, experienced an unexpected event of suspension leaked from the syringe: less than 0.5 given to patient. The event occurred on 22 Dec 2020 during administration of the first dose of the study medication. The sponsor considered the event as related to mRNA-1273.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PUB,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Underdose'],1,UNKNOWN MANUFACTURER, 927461,NY,,U,"The needle came off syringe and the patient did not receive a full dose; A spontaneous report was received from a pharmacist concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced the non-serious event the needle came off syringe and the patient did not receive a full dose. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 011J20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Dec 2020, the pharmacist reported that while administering the vaccine to the patient, the needle came off the syringe, and the patient did not receive a full dose. The patient had already left the office, and the pharmacist currently had no patient identifiers at the time. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, the needle came off syringe and the patient did not receive a full dose, was considered resolved on 22 Dec 2020. The reporter did not provide an assessment for the event, the needle came off syringe and the patient did not receive a full dose.; Reporter's Comments: This case concerns a patient of unreported age and sex, who experienced an unexpected event of the needle coming off syringe and the patient did not receive a full dose. The event occurred on 22 Dec 2020 during the administration of the first dose of the study medication. The sponsor considered the event as related to the mRNA-1273.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Underdose'],1,UNKNOWN MANUFACTURER,OT 927462,AZ,,U,"Syringe malfunctioned and leaking during administration; A spontaneous report was received from a pharmacist concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced syringe malfunctioned and leaking during administration. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 22 Dec 2020, a health care provider administered the mRNA-1273 vaccine to a patient. During the administration, the syringe malfunctioned and leaked during administration. The health care provider was uncertain if the patient received the full dose of the vaccine or how much of the vaccine was spilled. The patient had no observable symptoms and did not receive any treatment for the event. Action taken with mRNA-1273 in response to the event was not reported. The event, syringe malfunctioned and leaking during administration, was considered resolved on 22 Dec 2020. The reporter did not provide an assessment for the event, syringe malfunctioned and leaking during administration, to study drug.; Reporter's Comments: This case concerns a patient of unreported age and sex. The patient's medical history is not provided. The patient experienced an unexpected event of syringe malfunctioned and leaking during administration. The event occurred on 22 Dec 2020 during administration of the first dose of the study medication. The sponsor assessed the event as unrelated to the mRNA-1273 vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Underdose'],1,UNKNOWN MANUFACTURER,OT 927463,DE,,U,"Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 48-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 48-year-old subject who experienced the unlisted event of administered vaccine that was not stored in recommended temperature. The sponsor considers the event as Unassessable, because the event is a storage error.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/21/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Product storage error'],1,UNKNOWN MANUFACTURER,OT 927464,AZ,,U,"Syringe malfunctioned and leaking during administration; A spontaneous report was received from a pharmacist concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced syringe malfunctioned and leaking during administration. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 22 Dec 2020, a health care provider administered the mRNA-1273 vaccine to a patient. During the administration, the syringe malfunctioned and leaked during administration. The health care provider was uncertain if the patient received the full dose of the vaccine or how much of the vaccine was spilled. The patient had no observable symptoms and did not receive any treatment for the event. Action taken with mRNA-1273 in response to the event was not reported. The event, syringe malfunctioned and leaking during administration, was considered resolved on 22 Dec 2020. The reporter did not provide an assessment for the event, syringe malfunctioned and leaking during administration, to study drug.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered without any associated adverse events.; Sender's Comments: No adverse event",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Underdose'],1,UNKNOWN MANUFACTURER,OT 927484,MA,,M,"Severe allergic reaction; anaphylactic reaction; A spontaneous report was received from a physician, who was also a male patient who received Moderna's COVID-19 Vaccine and developed a severe/anaphylactic allergic reaction. The patient's medical history, as provided by the reporter, included a shellfish allergy and elevated Immunoglobulin E. He reported no history of adverse events following other immunizations, that all his immunizations were up to date, and that he gets the flu shot annually. Products known to have been used by the patient, within two weeks prior to the event, included pantoprazole, vitamin D, and vitamin B12. On 24 Dec 2020, minutes prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 intramuscularly for COVID-19 infection prophylaxis. Within minutes, the patient felt dizzy and his heart was racing. His throat felt swollen and he experienced shortness of breath (""heavy breathing"") with no wheezing or stridor, but with chest tightness that he felt was possibly related to anxiety about receiving the vaccine and the potential for allergic reaction. No supplemental oxygen was required. Vital signs showed a heart rate of 145, with normal blood pressure (BP) and oxygen saturation. After a few more minutes, he started to feel numbness and tingling in his mouth and tongue. He experienced diaphoresis (""drenched in a cold sweat""), skin pallor (""skin was severely pale""), felt faint, and reported that his blood pressure was undetectable by a monitor. He did not lose consciousness and denied any skin rash. The patient felt he was developing an allergic reaction and self-administered his personal epinephrine auto-injector. He felt better within five to six minutes after self-administration of epinephrine and was taken by stretcher to the Emergency Department for further evaluation and treatment of shortness of breath, dizziness, palpitations, and numbness. The patient was evaluated, treated, observed, and discharged four hours later. Treatment provided for the events while in the Emergency Department included diphenhydramine hydrochloride, intravenous (IV) fluids, IV steroids, and famotidine. On 25 Dec 2020, the patient felt fully recovered. On 26 Dec 2020, the patient felt dizzy and reported experiencing a ""rapid heart rate"" of 70-120 with a systolic BP that was abnormal for him at 150 mmHg. He also reported that he felt premature atrial contractions, for which he took his wife's propranolol. His heart rate came down, but he still felt flushing and dizziness for a few more hours. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, severe/anaphylactic allergic reaction, was considered resolved on 26 Dec 2020. The reporter assessed the event of severe/anaphylactic allergic reaction as related to Moderna's COVID-19 Vaccine due to the temporal association and the similarity of symptoms previously experienced with severe/anaphylactic allergic reactions to shellfish.; Reporter's Comments: Company Comment: This case concerns a male patient with medical history of shellfish allergy , who experienced an unexpected events of severe allergic reaction; anaphylactic reaction, dizzy, faint, heart racing, tongue prickled and went numb, cold sweat, blood pressure plummeted, shortness of breath, numbness and skin was pale..The onset of event occurred 15 hrs the first dose of vaccine administration . The events are assessed as possibly related to vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,UNK,PANTOPRAZOLE; VITAMIN D NOS; VITAMIN B12 NOS,,"Medical History/Concurrent Conditions: Fish allergy (Anaphylaxis; Severe; began at age 11, most recent episode in 2012); Immunoglobulin E increased; Shellfish allergy (Clam chowder); Shellfish allergy (Clam chowder); Shellfish allergy (Anaphylaxis; Severe; began at age 11, most recent episode in 2012)",,,"['Anaphylactic reaction', 'Blood pressure immeasurable', 'Blood pressure systolic abnormal', 'Chest discomfort', 'Cold sweat', 'Dizziness', 'Dyspnoea', 'Flushing', 'Heart rate increased', 'Hyperhidrosis', 'Hypersensitivity', 'Hypoaesthesia oral', 'Pallor', 'Palpitations', 'Paraesthesia oral', 'Pharyngeal swelling', 'Supraventricular extrasystoles']",1,MODERNA,OT 927488,,46.0,F,"had an occurrence on Monday of an outbreak of herpes; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse reporting for herself. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously took valaciclovir hydrochloride (VALTREX). Patient stated ""I stopped taking my Valtrex a week before getting the vaccine. I got the vaccine on Friday. I started having symptoms again and started taking it again"". Patient also stated ""I've been told that effectiveness of flu vaccine might not be as good for people taking this medication"". Patient was inquiring about taking Valtrex medication before/during her 2 dose vaccine. She stated that she is a nurse in healthcare and she received an email. She received her first dose of the Covid vaccine on a Friday and had an occurrence on Monday of an outbreak of herpes. She stated she was taking Valtrex to suppress her symptoms for a year and stopped taking her medication a week before receiving the vaccine. She stated that she tested for Covid a week before receiving the vaccine as well due to exposure at work. She stopped the medication and panicked thinking it would have an interaction since reading information regarding flu vaccine. Patient states she could not get up with HCP regarding stopping her Valtrex so she called Pfizer. She spoke to someone at Pfizer that asked her if it would be okay to relay her information to someone else and she said yes. Then she received a weird email from [Company name] that said they were made aware a person that was under your care received the flu vaccine. Patient states she does not administer vaccines, she works at the hospital. Patient states she called the company and they did not have any information. She also called her HCP who told her to contact Pfizer to see what the email is all about. Her HCP told her to restart her medication and there is no interaction with Valtrex. Her HCP informed her that the only time she should stop taking her Valtrex is if she was receiving the shingles vaccine or a live vaccine. The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Herpes virus infection'],1,PFIZER\BIONTECH, 927489,OH,58.0,F,"Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; caused her to go into the flare; Muscle joints pain; Extremely tired; Muscle joints pain; Experiencing flu like symptoms; Body ache; Headache; sick; feeling bad; The initial case was missing the following minimum criteria: specific product. Upon receipt of follow-up information on 01Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (BNT162B2 also reported as Covid 19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on 17Dec2020 at a single dose for covid-19 vaccination. Medical history included having something called Adult Still's which is bad Rheumatoid Arthritis. The patient's concomitant medications were not reported. The patient reported that she got the vaccine and was experiencing sever cramps in her legs and thighs, and muscle joints pain. She mentioned on a scale of 1-10 it is 20. The patient also experienced flu like symptoms which were body ache and extremely tired. The patient reported that she called because she received her first Covid shot on 17Dec2020 and she was really sick from then, she was talking like super sick. In Dec2020, she had muscle cramps, headache, no fever but like she had the flu. She has something called Adult Still's which is bad Rheumatoid Arthritis, so it caused her to go into the flare but she was still sick. She was still feeling bad. She was still having muscle pains in her leg. The patient mentioned that she had to go to the emergency room because she could barely move her leg. They told her that it was a combination of Adult still's and her Covid 19 shot, so they gave her some medications. They gave her Lyrica 75 mg, twice a day and it messed me up that she couldn't even function. So, now she had to come home from work and now she was still having the leg cramps and just not feeling well so what can she do to feel myself better. The outcome of the event cramps in legs was not recovered while the outcome of the other events was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: Rheumatoid arthritis (have something called Adult Still's which is bad Rheumatoid Arthritis); Still's disease,,,"['Arthralgia', 'Condition aggravated', 'Fatigue', 'Feeling abnormal', 'Headache', 'Illness', 'Influenza like illness', 'Muscle spasms', 'Myalgia', 'Pain', 'Pain assessment', 'Screaming']",1,PFIZER\BIONTECH, 927490,PA,45.0,M,"sore throat, cough, and headache; sore throat, cough, and headache; sore throat, cough, and headache; This is a spontaneous report from a contactable nurse. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), via an unspecified route of administration on 24Dec2020 as single dose for COVID-19 immunization. There was no medical history and no concomitant medications. The patient experienced sore throat, cough, and headache on an unspecified date. No treatment was given for the events. The outcome of sore throat, cough, and headache was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Cough', 'Headache', 'Oropharyngeal pain']",UNK,PFIZER\BIONTECH, 927491,,54.0,F,"throwing up; fever; body aches; her whole intestines hurt; it was horrible; thought she had contracted COVID-19; thought she had contracted COVID-19; tired; This is a spontaneous report from a contactable consumer. A 54-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140), via an unspecified route of administration on left arm on 17Dec2020 at 19:15, at a single dose for vaccination. Medical history included ongoing ulcerative colitis, onset date was unknown, but when she was about 25 years of age. Concomitant medication included ongoing azathioprine for ulcerative colitis, started probably 5-10 years ago and taken daily since. In the past, she took different products for ulcerative colitis off and on when she had an episode. This patient reported she was administered her first Pfizer COVID-19 Vaccine injection on 17Dec2020 and was just kind of tired on 17Dec2020; but she had onset of serious reactions to the COVID-19 Vaccine starting 18Dec2020 for 2 days straight and then as suddenly as the events started they suddenly stopped after 2 days with no lasting effects. She called to ask if there is any data about if the second dose of the COVID-19 Vaccine will be just like the first shot or if the events are just hit or miss; she is really hoping not to be that sick again with the second dose. Serious reactions to the COVID-19 Vaccine further described as sick for like 2 days straight. Afternoon of 18Dec2020 she was throwing up; had fever; body aches; thought she had contracted COVID-19 in between injection and onset of symptoms; she had no lung issues; her whole body hurt; she could not stop throwing up; her whole intestines hurt; it was horrible; she could not hold anything down for like 2 straight days and then just left on 20Dec2020. Scheduled date for second dose was on 06Jan2021, she has no plan to change dose schedule. The outcome of the event of tired recovered in Dec2020, while other events recovered on 20Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,UNK,,"Ulcerative colitis (Verbatim: Ulcerative colitis, onset date unknown, but when she was about 25 years of age.)",,,,"['Fatigue', 'Gastrointestinal pain', 'Malaise', 'Pain', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH, 927492,IA,53.0,F,"felt really tired; sore arm/ arm was sore to touch and to lift it up/ hurt to touch; chills; fever; body aches; snoring bad; freezing/ can't get warm; shaking; felt terrible; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the right arm on 28Dec2020 13:15 at a single dose for COVID-19 immunization. She has had the Coronavirus before and wanted to know if previously having the virus might make her side effects worse. She had COVID 19. She got her positive result on 06Aug2020. Her husband had it too. She knows what it is like. She didn't have to go to the hospital, but she had a severe enough case. She had the fever, dry cough, body aches, nausea, and poops. She has been getting body aches after having COVID really intense. She gets tired very easily. She had fibromyalgia was diagnosed more than 10 years ago and ongoing, before the year 2000; acid reflux was diagnosed five or six years ago; high blood pressure was diagnosed back in 2007; high cholesterol; wheezing for a couple of years and depression. The patient was also taking a water pill. Concomitant medication included omeprazole ongoing for acid reflux, hydrochlorothiazide (HYDROCHLOROTH, 25 mg) ongoing, losartan 100 mg ongoing, desvenlafaxine 75 mg ongoing for depression, montelukast 10 mg ongoing for wheezing, atorvastatin calcium ongoing for cholesterol. When asked for the lot number the patient said that she thinks it is EL1284 but it could possibly be ELI284. On 28Dec2020, the patient felt really tired, has a sore arm with chills, fever and body aches. The same day she got the vaccine she had felt fine. She came home and did a few things. She sat down for a minute and then it was like wham. She told her husband she was done. She went to sleep fast and slept for a couple of hours. She went to work the next morning and her arm was sore to touch and to lift it up. Sometimes when you get the flu shot it is like that too. She does not have any red marks where it was injected. She only knows where it was because it hurt to touch. She got really tired at work about 11:30AM. Her body started aching. She was being tested twice a week for Corona COVID. She had just been tested on 28Dec2020 morning before the vaccination and was negative. On an unspecified in Dec2020, she was freezing and shaking. She cannot get warm. It was like that for a couple of hours. Usually her temperature runs low. It was up to 100.1 degrees Fahrenheit which is high for her because she usually is on the lower end. She felt really ugh.The symptoms after the vaccine reminded her of when she had COVID. She had a low fever and body aches and felt terrible. Her boss wanted to know if she had the flu. The patient does not think so because it would be ironic the day after she gets the shot. She was assuming it was the side effects from this. She further clarified wham as that she was really tired and it came over her really quick. She sat in the chair and got a blanket. Her husband said she was snoring bad (28Dec2020). Two hours later the dogs woke her up and she thought it was the middle of the night. It wasn't it was early. On unspecified date in Dec2020, she had a bout and her body started aching. A day after, she does not feel that bad, does not have fever and her body was not aching. That night when she got home she could not sleep on her arm because it was sore. The next day was when it was hard to lift it. She had the injection in the right arm, which is the arm she uses. It was still sore to touch. She has fibromyalgia. She is not sure if that is why she is aching. She is not sure if that kicked it in high gear. The vaccine was administered in a Long Term Care Center. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The events did not result to emergency room nor physician visit. The outcome of the event fever and body aches recovered on an unspecified date in Dec2020; outcome for all other events was unknown. Information on the lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/01/2020,,UNK,; HYDROCHLOROTH; ; ; ;,Fibromyalgia,Medical History/Concurrent Conditions: Acid reflux (esophageal) (Acid Reflux was diagnosed five or six years ago.); Blood pressure high; COVID-19 (\); Depression; Diuretic therapy; Fatigue; General body pain; High cholesterol; Wheezing,,,"['Body temperature', 'Chills', 'Fatigue', 'Feeling cold', 'Malaise', 'Pain', 'Pyrexia', 'SARS-CoV-2 test', 'Snoring', 'Tremor', 'Vaccination site pain']",1,PFIZER\BIONTECH, 927493,MT,28.0,F,"Post-viral rash on day 10-13 after vaccine administration; Extreme fatigue; This is a spontaneous report from a contactable pharmacist (patient). A 28-year-old female patient received BNT162B2 (lot number and expiry date not reported), via an unspecified route of administration on the left arm on 17Dec2020 at 16:00 at single dose for COVID-19 immunization. Medical history included migraine, PCOS from an unknown date and unknown if ongoing and known allergy to kiwi. Concomitant medication included naproxen and methocarbamol (ROBAXIN). The patient experienced extreme fatigue and post-viral rash on day 10-13 after vaccine administration on 27Dec2020. Therapeutic measures were taken as a result of post-viral rash which included treatment with Benadryl (in case of allergic reaction). The patient did not recover from the events. Information about Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/27/2020,10.0,WRK,; ROBAXIN,,Medical History/Concurrent Conditions: Fruit allergy; Migraine; Polycystic ovary,,,"['Fatigue', 'Viral rash']",1,PFIZER\BIONTECH, 927494,,31.0,M,"I have start developing a red bruise like the bubbles on my arm; it seems more like under skin there is a bubble and not like inflammatory muscles; I have start developing a red bruise like the bubbles on my arm; it seems more like under skin there is a bubble and not like inflammatory muscles; administered via sub cutaneous with a half inch needle; This is a spontaneous report from a contactable Pharmacist reporting for himself. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730 and expiry date: 31Mar2021), Subcutaneously on 29Dec2020 at 16:40 at single dose at Left Deltoid at Hospital for Prevention. There were no medical history or concomitant medications. There were no prior vaccinations within 4 weeks, no family medical history, and no additional vaccines administered on same date of Pfizer suspect. The patient wanted to know what the recommendations are if the COVID Vaccine was administered subcutaneously. He clarified he received the COVID Vaccine, but he believed it was administered via sub cutaneous with a half inch needle on 29Dec2020 at 16:40. He knew with other vaccines such as the Flu Vaccine, if it is not given intramuscularly, a patient is subject to revaccination. The patient wanted to know if he needs to be revaccinated with the COVID Vaccine since it wasn't an intramuscular injection. Relevant Tests were None. On 01Jan2021, the patient stated that he had started developing a red bruise like the bubbles on his arm; it seemed more like under the skin there was a bubble and not like inflammatory muscles. The patient reported that the shot was given with the half inch of needle because it was only recommended with the one inch or larger; so actually, he was trying to find it on the mail. The question he wanted to ask was if it went to the deep muscle enough or possibly into the tissue. But over the last, like 24 hours, he has started developing a red bruise like the bubbles on his arm. It didn't feel like he ever had any muscle pain or anything and it seemed more like under the skin there was a bubble and not like inflammatory muscles. The patient's weight was reported as 104.33 kg or 230 pounds. The patient did not receive any treatment for the events. Outcome of the events was unknown. Causality between the event ""I have start developing a red bruise like the bubbles on my arm; it seems more like under skin there is a bubble and not like inflammatory muscles"" and BNT162B2 was reported as related. Follow-up (01Jan2021): New information received from a contactable pharmacist includes additional events (contusion, blister), an additional laboratory data, and the clinical course of the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Other Conditions: No",,,"['Blister', 'Contusion', 'Incorrect route of product administration', 'Weight']",UNK,PFIZER\BIONTECH,OT 927495,FL,50.0,M,"positive COVID-19 test with symptoms; positive COVID-19 test; gastritis; diarrhea; This is a spontaneous report from a contactable other hcp (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685; expiry date was not reported), via an unspecified route of administration on the upper right arm on 21Dec2020 at single dose for COVID-19 immunization. Medical history included blood pressure high, attention deficit hyperactivity disorder (ADHD), hypertension all from an unknown date and unknown if ongoing, and was a former smoker. Concomitant medication included lisinopril and methylphenidate. The patient reported that after he received the vaccine, he tested positive for Covid on 30Dec2020. The patient further reported that he ended up getting significant gastritis on Christmas Eve, which he didn't think about acquiring COVID, he had had the vaccine, he ate a bunch of holiday fare, so he thought he had got a stomach bug or something like that. He says he had considerable diarrhea on Christmas morning, but no fever or chills, then those symptoms resolved by Saturday, and he didn't think about it, he didn't have any issues. He says that he went to get tested, which they do frequently, and his temperature was checked frequently at the places he goes and he had no fever, and is still not febrile now. He says that he gets a weekly COVID test which allows for him to enter different facilities, and this was the first time in 9 months that he tested positive since this all came out. He says he has worked in some heavy duty places, but he wears his PPE, his respirator, his shield, and still did this stuff after he got the vaccine, he didn't let his guard down since it might take a while for immunity to kick in, but he still didn't think that it could be possible to have COVID on Christmas Eve, he was rather surprised he was positive. The patient confirms that he hasn't had the second dose of the vaccine yet. He says that his diarrhea improved on day or two starting after he had been having bloating on Christmas Eve and Christmas morning. He says his diarrhea resolved, he took no medication for it, and had no change in his heart rate or breathing, no problems anywhere else, he didn't feel that bad, except for the going to the bathroom. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Dec2020. The outcome of the events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this subject cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/24/2020,3.0,UNK,;,,Medical History/Concurrent Conditions: ADHD; Blood pressure high; Ex-smoker; Hypertension,,,"['Abdominal distension', 'Diarrhoea', 'Gastritis', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 927496,,,U,"Reported to get the vaccine, and within a couple of hours or days, test positive for COVID; Reported to get the vaccine, and within a couple of hours or days, test positive for COVID; This is a spontaneous report from a contactable other HCP received from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient reported to get the vaccine, and within a couple of hours or days, test positive for covid. The outcome of the event was unknown Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of SARS-CoV-2 test positive and LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520145 different patients, same drug and event",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 927497,OK,31.0,M,"Cough; Fever; body aches; Tested positive for COVID after the first dose of the vaccine/tested positive for COVID-19; Tested positive for COVID after the first dose of the vaccine/tested positive for COVID-19; This is a spontaneous report from a contactable physician reporting for himself from a Pfizer sponsored program, IBCC (Inbound Call Center for HCPs). A 31-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) intramuscular Deltoid Left, on 17Dec2020 9:00, single dose for COVID-19 immunisation. Relevant medical history included seasonal allergies and asthma. Concomitant medications were reported as none. The patient took the first dose of the COVID-19 Vaccine and he is schedule on 07Jan2021 for his second dose. After the first dose he tested positive for COVID on 30Dec2020. The patient got tested for COVID-19 around 10:30 a.m. The patient hasn't seen a physician and he doesn't don't plan on it. The patient had a cough on an unspecified. Early on he had a fever and body aches but that passed after the first day. Caller clarifies the fever and body aches started Sunday and were gone by Tuesday morning. The cough started on Monday and is still ongoing and persisting. The patient was not hospitalized in response to the events. Outcome of the event cough was not recovered, the events fever and body aches recovered on an unspecified date, while it was unknown for tested positive for COVID after the first dose of the vaccine.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the SARS-CoV-2 test positive, LOE and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/30/2020,13.0,PVT,,,Medical History/Concurrent Conditions: Allergy; Asthma,,,"['Cough', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 927498,VA,,F,"Test positive for COVID after the first vaccine dose; Test positive for COVID after the first vaccine dose; This is a spontaneous report from a contactable Physician. This Physician reported similar events for 2 patients. This is the 2nd of 2 reports. A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 vaccination. The patient's relevant medical history and concomitant medications was not reported. The patient was tested positive after the first dose of the vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520651 same reporter/product/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 927499,VA,,F,"Test positive for COVID after the first vaccine dose; Test positive for COVID after the first vaccine dose; This is a spontaneous report from a contactable Physician. This Physician reported similar events for 2 patients. This is the 1st of 2 reports. A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration in left deltoid on 16Dec2020 at a single dose for COVID-19 vaccination. There were no relevant medical history and concomitant medications. The patient was test positive for covid after the first vaccine dose on 27Dec2020 with outcome of not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID 19 test positive and LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520645 same reporter/product/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/27/2020,11.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 927500,,32.0,F,"Numbness to face around nose area.; This is a spontaneous report from a non-contactable nurse (the patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 30Dec2020 at 13:30 (at the age of 32-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On an unspecified date, the patient experienced numbness to face around nose area. The clinical outcome of numbness to face around nose area was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,,,UNK,,,,,,['Hypoaesthesia'],1,PFIZER\BIONTECH,OT 927501,MA,25.0,F,"Cold sweats; Fever of 102; Headache; Fatigue; Nausea; Pain in arm; This is a spontaneous report from a contactable nurse. A 25-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number=Ec0142, via an unspecified route of administration, in right arm on 30Dec2020 at 19:30 (at the age of 25 years-old) as a single dose for COVID-19 immunization. The patient did not receive any vaccinations 4 weeks prior to vaccination with COVID-19 and also had not taken any other medications in 2 weeks. The vaccine was administered at a hospital. Prior to the vaccination, the patient had not been tested for COVID-19. Medical history included an allergy to Kiwi fruit. There were no concomitant medications. On 30Dec2020, the patient experienced cold sweats, fever of 102, headache, fatigue, nausea and pain in arm. The patient was not hospitalized for the events and no treatment was administered. The clinical outcome of the events of cold sweats, fever of 102, headache, fatigue, nausea was recovering. After vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Fruit allergy,,,"['Body temperature', 'Cold sweat', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 927502,TX,,F,"positive for COVID-19 after 1st dose; positive for COVID-19 after 1st dose; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse was inquiring about receiving the second dose of vaccine after testing positive for COVID-19 after 1st dose. Outcome of the event was unknown. Information on Lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 927503,,,M,"came out positive for Covid-19; came out positive for Covid-19; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 29Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient came out positive for covid-19 on 30Dec2020 and inquired if he should still get the 2nd dose. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 927504,LA,38.0,F,"Got her first dose of the Covid vaccine, tested positive afterward; This is a spontaneous report from a contactable Health Care Professional (the patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EK5730, expiration date unknown) intramuscularly, on an unspecified date (at the age of 38-years-old) at an unspecified dose in the right arm for COVID-19 immunization. Medical history included asthma from an unknown date. The patient's concomitant medications were reported as ""supplements."" The patient stated that she got her first dose of the COVID vaccine, tested positive afterward (COVID-19). The patient states that she is ""still going to be in her 10 day window to get that second dose. She is wondering if she can still get it or if she has to start over."" When probed for any laboratory test, the reporter stated ""I had a COVID test before the vaccine so I guess that's a lab test"" (CONFIRMATION PENDING with regard to timing COVID test in relation to vaccine administration).The clnical outcome of COVID-19 was not provided.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Asthma (Verbatim: Asthma),,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 927505,KS,43.0,F,"testing positive for covid/ they have had a patient have a positive COVID test after vaccine was given; testing positive for covid/ they have had a patient have a positive COVID test after vaccine was given; This is a spontaneous report from a contactable pharmacist via medical information team and a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730, expiration date 31Mar2021), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history included ongoing asthma. The reporter was not aware of any allergies, adverse reactions to previous vaccines, significant medical history or any relevant family medical history of the patients. Concomitant medications were reported as none. It was reported that that they had a patient who had a positive COVID test after vaccine was given. The patient who received the vaccine on 18Dec2020 now testing positive for COVID. The patient received the first vaccine dose on 18Dec2020. She tested positive 30Dec2020. They wanted to give her monoclonal antibodies (Bamlanivimab) but they don't know how that would interact with the vaccine. Also, they didn't know how the product and the positive test would play into her already having the first dose and getting the second dose. The second shot would be due on 08Jan2020. The patient was not at the facility at the point of reporting, they had been talking to her by phone. The type of test done was unknown. No treatments known. The outcome of the event ""positive COVID test after vaccine was given"" was not recovered. The event was assessed as medically significant, and unrelated to vaccine by reporter. The seriousness assessment option was made due to her history of asthma.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 cannot be completely excluded for reported ""positive COVID test after vaccine was given"".",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/30/2020,12.0,UNK,,Asthma,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 927506,MA,58.0,M,"Heart rate increased; Swelling arm; Arm soreness; soreness at the vaccine injection site; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686, expiration date unknown) via an unspecified route of administration on 28Dec2020 at 13:00 (at the age of 58-years-old) at an unspecified dose in the upper left arm for COVID-19 vaccination. Medical history was reported as ""no pre-existing conditions."" He mentioned that he reviewed his allergies with a pharmacist prior to vaccination but did not specify what his allergies were. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was a tobacco user from an unknown date. The patient also reported a history of pneumonia which was reported to have occurred on seven different occasions following each of seven different vaccinations with the flu vaccine (manufacturers unknown) prior to 2013. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. He stated that after receiving the COVID 19 Vaccine he had side effects. He said the side effects went away at twenty four hours later, but he is still having one side effect, and has a concern. He clarified that he has an elevated heart rate since getting the COVID 19 Vaccine. He said he has never had an elevated heart rate before getting the COVID 19 Vaccine. He reported his heart rate is normally low, between 62-65. He said when he was at work on 28Dec2020 his heart rate was OK, but prior to going to bed that night his heart rate was 93 - 95. He said he thought at first he was just stressed. He also reported the COVID 19 Vaccine is the only thing he has taken. He mentioned that his heart rate has been down to 93, but then up to 105, and higher. He specified that he first presented with an elevated heart rate between 4:00 5:00PM on Tuesday, 29Dec2020. He said the elevated heart rate subsided enough for him to sleep later that day. He said he then started work around 10:00AM today, 30Dec2020, and felt the elevated heart rate in himself, and didn't say anything to anyone at work. He said when his heart rate got bad, it was about 12:30PM today and that today (30Dec2020) at work he didn't feel right at lunch, so he took his oxygen level and heart rate. He said his heart rate was 141. He said he called his primary care doctor, but didn't go to the emergency room. He said he doesn't have chest pain. He said he said something about his heart rate to a staff member at work, and the staff member tested his heart rate, and told him it was 141. He said he spoke to the nurse at his doctor's office, and the nurse said the doctor couldn't do much, and that he could go to emergency room or their practice's urgent care that is open until 7:00PM. He said he tried to go to the hospital emergency room, but ended up driving by because the hospital was so busy they were triaging patient's in the parking lot. The patient also experienced arm swelling and arm soreness following the vaccination on 28Dec2020. He said he could feel the soreness at the vaccine injection site when he moved his left arm. He stated that the swelling was down to his biceps and it resolved within 12- to 14 hours after the vaccination. As treatment, the patient took a generic 81 mg Baby Aspirin (UPC Number: 050428323922, Lot Number: P110657 Expiration Date: May2020) on 30Dec2020 between 3:00 and 3:30. The patient stated that the generic 81mg baby aspirin was an expired product. The clinical outcome of heart rate increased was not recovered and the clinical outcome of arm swelling, arm soreness and vaccination site soreness was recovered on 28Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,Medical History/Concurrent Conditions: Allergy; Pneumonia; Smoker (he has no preexisting conditions),,,"['Body temperature', 'Heart rate', 'Heart rate increased', 'Oxygen saturation', 'Pain in extremity', 'Peripheral swelling', 'SARS-CoV-2 test', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 927507,KS,59.0,F,"Contracted Covid; Contracted Covid; This is a spontaneous report from a contactable Other Health Professional (patient). A 59-year-old female patient received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration at left arm on 21Dec2020 18:00 at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). The patient received the unspecified concomitant medications within 2 weeks of vaccination; patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was contracted COVID on 29Dec2020 20:00. The event resulted in Doctor or other healthcare professional office/clinic visit. Patient received the treatment Monochrome antibiotic for event. The patient received the COVID test post vaccination on 29Dec2020. The COVID test type post vaccination was Nasal Swab, COVID test name post vaccination was RNA, COVID test result was Positive. The patient was not COVID prior vaccination. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered. Information on the Lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the vaccination with BNT162B2 in this patient cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/29/2020,8.0,PVT,,,Medical History/Concurrent Conditions: COPD,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 927508,VT,49.0,F,"100.7 temperature/her temperature and it was 101.7; she was up all night/she didn't sleep; It is very painful; migraines; she felt warm; joint pain; dull headache; tenderness at the injection; chills; as had joint pain and fatigue ever since her COVID-19 diagnosis in October/the arthritis has flared from it; fatigue/joint pain and fatigue are getting worse; This is a spontaneous report from a contactable consumer. A 49-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on the left arm on 30Dec2020 10:40 at single dose for covid-19 immunisation. Medical history included from Feb2020 and ongoing she is currently a breast cancer patient/she had breast cancer, has lymphedema in the right due to breast cancer and on 31Oct2020, she tested positive for COVID and that ever since she was positive, her joints and skin, shins and upper arms and legs are really tender, and hips, wanted to know if that is normal. Had joint pain and fatigue ever since her COVID-19 diagnosis in October. There were no concomitant medications. The patient previously took H1N1 shot and her arm got really big and they watched for cellulitis discomfort. The patient stated on Dec2020, ""received the COVID-19 vaccine on 30Dec2020 and is reporting 100.7 temperature, dull headache, tenderness at the injection, chills, joint pain and fatigue. She reported that she has had joint pain and fatigue ever since her COVID-19 diagnosis in October. The patient contacted COVID, she tested positive on 31Oct2020, and still has no taste or smell, and the biggest thing right now, that ever since she was positive, her joints and skin, shins and upper arms and legs are really tender, and hips, wanted to know if that is normal. She wants to know, where it has gone into the joint, the arthritis has flared from it, from her testing positive, it will be 9 weeks tomorrow since she had COVID, and she is not 100%, and yesterday she had the COVID vaccine, her first dose, and she was up all night, her joints and muscles were in a lot of pain, but she had been like that, and this morning she took her temperature and it was 101.7. Does it mean can't have the shot in 3 weeks? She has had health issues this year, she had breast cancer, and her oncologist wanted her to have the vaccine, but it concerns her with all the pain in her joints swelled, and wanted to know if it is a side effect due to COVID. States she is still coughing, she wants to know if Pfizer thought this was a side effect of COVID, since she tested positive in October, will she have to live like that? It is very painful. Her shot went fine at 10:40 yesterday morning, fine, but she has been experiencing stiffness and joint pain, and she contacted COVID in October, thinks this doesn't have to do with the shot, this has been this way since October, and her husband said to ask- will it be like this since she contacted COVID, and the only thing, this morning she had a headache, but she didn't sleep and she gets migraines it she doesn't sleep, and she took her temperature, she felt warm and it was 101.7. Her temperature was 101.7 about a half hour ago (31Dec2020), she takes her temperature now, states it is now 100.8. Stated that she probably needs to speak to her doctor for her questions. Got up a 1am and took Ibuprofen. Her joints were so sore from when having COVID and so she went back to sleep and slept off and on. Got up at 4am this morning with the dull headache, it was not enough to be considered a migraine, so she took another 800mg Ibuprofen. Headaches: states it is just a dull headache, she hasn't taken Ibuprofen yet this morning, she is not a big medicine person, she is trying to see if it will go away, but if it is worse she will take migraine medicine"". The outcome of ""as had joint pain and fatigue ever since her COVID-19 diagnosis in October/the arthritis has flared from it"", ""she was up all night/she didn't sleep"", ""It is very painful"", ""migraine"" and ""she felt warm"" were unknown. Other events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/01/2020,,PVT,,Breast cancer (she is currently a breast cancer patient/she had breast cancer),Medical History/Concurrent Conditions: Arthritis; COVID-19; Fatigue; Lymphedema,,,"['Arthralgia', 'Arthritis', 'Body temperature', 'Body temperature increased', 'Chills', 'Fatigue', 'Feeling hot', 'Headache', 'Insomnia', 'Migraine', 'Pain', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 927509,CA,43.0,F,"extremely high heart rate (142bpm); muscle aches; chills; O2 sats ""dropped to 97%""; This is a spontaneous report from a contactable healthcare professional (HCP) for herself. A 43-year-old female patient received first dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) at a single dose on 28Dec2020 at 13:30 for Covid-19 immunization. The patient had recently diagnosed with Covid-19 and ""recover/off quarantine"" on 12Dec2020. Concomitant medications were not reported. After vaccination, the patient experienced extremely high heart rate (142bpm), muscle aches, chills, O2 saturation dropped to 97%. The patient did seek medication attention/went to ER. She had to miss work. High heart rate resolved on the same day and other events resolved after 48 hours. The patient stated that she believed she took it too soon because she still had the antibodies from Covid, the doctors were saying they were not sure it was from vaccine, but she was sure it was. The patient made up her mind to not take the 2nd dose as she was scared. She stated that she did not want to go through that again, she could have had cardiac arrest. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,,,"Medical History/Concurrent Conditions: COVID-19 (recently diagnosed with covid-19. ""recover/off quarantine"" 12Dec2020)",,,"['Chills', 'Heart rate', 'Heart rate increased', 'Myalgia', 'Oxygen saturation', 'PO2 decreased']",1,PFIZER\BIONTECH, 927510,WA,58.0,F,"Rash on neck and chest; Rash on my face across my nose and cheeks; This is a spontaneous report from a contactable other HCP (healthcare professional) who reported for herself. A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EK5730) via an unspecified route of administration on 28Dec2020 at 15:00 (at the age of 58-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included arthritis, hypothyroidism and chronic back pain and arthritis in back; all from unspecified dates and unspecified if ongoing. It was reported that the patient did not have any allergies to medications, food or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date. Concomitant medications (taken in two weeks) included duloxetine hydrochloride, levothyroxine, nortriptyline and methocarbamol (ROBAXIN); all taken for unspecified indications from unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Dec2020 at 19:00 the patient experienced a ""rash on my face across my nose and cheeks"" and on 30Dec2020 the patient experienced ""rash on neck and chest"". It was reported that ""the evening after my vaccine I developed a rash on my face across my nose and cheeks. The next day I developed a rash on my neck and chest and the rash on my face was gone. I still have a rash on my neck and chest. No fever or other symptoms."" It was reported that the adverse events were non-serious and did not require treatment nor hospitalization. The clinical outcome of the event ""rash on my face across my nose and cheeks"" was recovered/resolved on an unspecified date and the outcome of the event ""rash on neck and chest"" was not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,WRK,CYMBALTA; ; ; ROBAXIN,,"Medical History/Concurrent Conditions: Arthritis (chronic back pain / arthritis in back); Chronic back pain (chronic back pain / arthritis in back); COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?:Yes); Hypothyroidism",,,['Rash'],1,PFIZER\BIONTECH, 927511,,,M,"He lost the sense of smell on 28Dec2020 and later tested positive; He lost the sense of smell on 28Dec2020 and later tested positive; He lost the sense of smell on 28Dec2020 and later tested positive; This is a spontaneous report from a contactable other healthcare professional (HCP). A male patient (respiratory therapist) of an unspecified age received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as the first dose via an unspecified route of administration on 16Dec2020 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. He lost the sense of smell on 28Dec2020 and later tested positive in Dec2020. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/01/2020,,UNK,,,,,,"['Anosmia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 927512,,,F,"I came down with a COVID infection; I came down with a COVID infection; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not reported) via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient came down with a COVID infection on 23Dec2020 with outcome of unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event ""came down with a COVID infection"" based on the known safety profile. However the short duration of 5 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/23/2020,5.0,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 927513,KS,64.0,F,"Rash occurred approx 48 hrs after receiving vaccine. Both arms, lower legs, feet, neck.; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899) intramuscular at first dose on 17Dec2020 at single dose for covid-19 immunisation in left arm in hospital. Medical history was not reported and no known allergy, no allergies to medications, food, or other products. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), atorvastatin, fish oil and 'women's 50+ MV'. The patient experienced rash occurred approximately 48 hours after receiving vaccine, both arms, lower legs, feet, neck on 19Dec2020. No treatment for event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of event was resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/19/2020,2.0,PVT,EFFEXOR; ;,,,,,['Rash'],1,PFIZER\BIONTECH,OT 927514,RI,47.0,F,"Rash on both legs; nausea; diarrhea; runny nose; epigastric pain; cough; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number ej1685) on 20Dec2020 13:15 at single dose intramuscularly in the left arm for COVID-19 immunization. Relevant medical history included unspecified allergies (known allergies: Yes. Allergies to medications, food, or other products: yes). There were concomitant medications. The patient experienced rash on both legs, nausea, diarrhea, runny nose, cough, epigastric pain on 20Dec2020 20:00, which resulted in emergency room/department visit or urgent care. The reporter (patient) considered the events were non-serious. It's unknown if any treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. On 25Dec2020, the patient was tested for COVID-19 (Nasal Swab) and the result was negative. The patient recovered with lasting effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/20/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Allergy,,,"['Abdominal pain upper', 'Cough', 'Diarrhoea', 'Nausea', 'Rash', 'Rhinorrhoea', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 927515,CA,,F,"Stomatitis; lips completely peeled off; submandibular lymph nodes; headache; This is a spontaneous report from a contactable physician. A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via intramuscular in left arm on 17Dec2020 11:00 at first single dose for COVID-19 immunization. Medical history reported as none. No other concomitant medications were received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. The patient experienced stomatitis on day 11 post vaccine (lips completely peeled off) Day 14- submandibular lymph nodes and headache. Adverse event start date: 27Dec2020 16:00. Events were considered as non-serious. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/27/2020,10.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Headache', 'Lip exfoliation', 'Lymphadenopathy', 'Stomatitis']",1,PFIZER\BIONTECH,OT 927516,AL,50.0,F,"sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; numbness; tingling; burning sensation in throat and the back of tongue; burning sensation in throat and the back of tongue; mild nausea; allergic reaction; dizzy, light-headed; ashen pale; head felt heavy; Burning and itchiness on chin persists; Burning and itchiness on chin persists; This is a spontaneous report from a contactable nurse (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm on 29Dec2020 12:00 at first single dose for COVID-19 immunization. Medical history reported as none. No known allergies. Concomitant medication the patient received within 2 weeks of vaccination included ergocalciferol (VIT D), linum usitatissimum seed oil (FLAX SEED OIL), cyanocobalamin (VITAMIN B12) and multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 2 min after shot the patient was dizzy, light-headed, ashen pale, and head felt heavy. After sitting and lying down about 45 min, the patient felt numbness, tingling, and a burning sensation in throat and the back of tongue. MD took O2 sat (99%) and heart rate (72). The patient felt mild nausea for 5 min. MD gave her Pepcid 20 mg as antihistamine. About 30 min later, the patient noticed sores and redness at the back of throat and tongue. The patient consulted MD and she advised the patient to go to employee health clinic. The clinic MD stated the patient was probably having some kind of allergic reaction to vaccine. The patient was given steroid shot and Benadryl 25 mg PO (per oral) and observed for 90 min. The patient left and was given Medrol Dose pack if symptoms persisted after 2 days. The patient was told to take Benadryl 25 mg PO (per oral) 4-6 hours and Pepcid 20 mg PO (per oral) BID (twice a day) for 1-2 days. Redness, sores at back of throat and tongue persist. Burning and itchiness on chin persists. The patient had no difficulty breathing at any time. Adverse event start date was reported as 29Dec2020 12:15 PM. Events were non-serious. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included: Benadryl 25 mg PO and a steroid shot IM. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events sores and redness at the back of throat and tongue, burning and itchiness on chin persists not recovered, of other events was recovered with sequel.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/01/2020,,PVT,VIT D; FLAX SEED OIL; VITAMIN B12 [CYANOCOBALAMIN],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Dizziness', 'Facial pain', 'Glossodynia', 'Head discomfort', 'Heart rate', 'Hypersensitivity', 'Hypoaesthesia', 'Nausea', 'Oropharyngeal pain', 'Oxygen saturation', 'Pallor', 'Paraesthesia', 'Pharyngeal erythema', 'Pruritus', 'Throat irritation', 'Tongue discomfort', 'Tongue erythema']",1,PFIZER\BIONTECH, 927517,NJ,62.0,M,"Felt pinched when the vaccine was administered; soreness at the muscle site; little muscle soreness from the vaccine; Postnasal drip in throat; Feeling warm then really hot; Feeling weak; Clammy; sweaty; As if he was going to pass out; almost like a vagal reaction if you got a needle or were scared; vagal reaction but delayed; Heart might have been beating fast; Experience is like the dizziness related in the signs of a severe allergic reaction; Experience is like the dizziness related in the signs of a severe allergic reaction; Anxiety; anxious; This is a spontaneous report from a contactable physician (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in left deltoid, on 30Dec2020 10:30, at a single dose, for COVID-19 immunization. The patient's medical history included ongoing mild intraocular pressure. The patient's concomitant medication included unspecified eye drops for a mild intraocular pressure. The patient previously took tetanus vaccine and experienced vagal reaction and passed out (in his childhood). The patient's past COVID tests were always negative. On 30Dec2020, the patient received it at a facility where he is a physician on staff, and they started giving it that day. It was administered by a pharmacist who was very clean and professional, and everything was fine. The patient received the COVID-19 vaccine in the left deltoid and felt pinched when the vaccine was administered, and he felt fine. He did not have any immediate reaction. He sat down, then got up and was standing talking to some colleagues, and about 10 to 15 minutes later, they were talking and felt a little postnasal drip in throat. His colleagues said that is what they felt as well. About 10 minutes later, the patient was feeling warm then really hot to the point where he felt the need for cool air. He added feeling weak and clammy as if he was going to pass out. He started to feel weak and warm and almost like a vagal reaction if you got a needle or were scared. It was almost like he felt hot, sweaty, and weak and feeling like he needed to get to a cool place and sit down. The patient's heart might have been beating fast, but he did not check his pulse. The patient went outside where the temperature was in the thirties and cold. The patient broke out in sweat and felt weak. The patient sat down, and it was cold outside, and he felt better. It passed and he felt fine after that. The symptoms lasted 10-15 minutes top, and it was resolved after the peak. The patient had soreness at the muscle site which got better overnight; little muscle soreness from the vaccine. The patient then got better and felt no other symptoms. He looked up the side effects and talked to the pharmacist. He spoke with a pharmacist, who provided the information on the reported adverse reaction of the COVID-19 vaccines and the signs of a severe allergic reaction included in the PI. He is not an allergic type person. He is familiar with those reactions and never had any trouble. He wasn't quite sure if it was related but then said it is probably somewhat related. The patient explained that he doesn't have any of the reported adverse reactions in the PI; but his experience is like the dizziness related in the signs of a severe allergic reaction in the PI, and he did feel that his heartbeat was fast. He is fine now though. The patient asked if his event is related to the vaccine and what is the impact on getting the second dose when reacting to the first. The patient was thinking that this event is a vagal reaction but delayed. He also explained that he was speaking with his colleagues, right after receiving the COVID-19 vaccine, regarding postnasal drip reaction. The patient also wondered if anxiety related to this discussion could have triggered his symptoms. Originally, he thought it was just him. But after talking to colleagues, maybe he was just a little anxious. He did not feel anxious going in. He did not need any intervention. He did not take any diphenhydramine hydrochloride (BENADRYL) or anything. He sat and rested, and it passed. He has been fine since. He needs a second dose in 3 weeks. There is not a lot of information about the side effects. It was not like he got a rash. He did not have any swelling of the tongue or throat. He just wanted to find out about if he should get the second dose. He really wanted to get the second dose. He just wanted to know if this was common or a concern and should he take the second dose. There were a lot of people getting the vaccine and this was not anything that stopped anyone from getting it. He is just trying to make sure and see how likely it was that it was related to the vaccine and how does it affect him getting the second dose. The patient was recovering from ""Felt pinched when the vaccine was administered; soreness at the muscle site; little muscle soreness from the vaccine"". The outcome of ""Postnasal drip in throat"" and ""Anxiety; anxious"" was unknown. The patient recovered from the other events on 30Dec2020. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/01/2020,,UNK,,Intraocular pressure abnormal,,,,"['Allergy to vaccine', 'Anxiety', 'Asthenia', 'Cold sweat', 'Dizziness', 'Feeling hot', 'Heart rate', 'Heart rate increased', 'Presyncope', 'SARS-CoV-2 antibody test', 'Upper-airway cough syndrome', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 927518,CA,37.0,M,"Numbness to right arm; This is a spontaneous report from a contactable nurse (patient) reported for himself. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: PfizerBiontech; lot number: 4c9231) intramuscularly at right arm on 30Dec2020 at 09:45 AM at a single dose (dose number: 1) for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was nursing Home/Senior Living Facility. No relevant medical history and concurrent conditions. No known allergies (no allergies to medications, food, or other products). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced numbness to right arm on 30Dec2020 at 03:30 PM. The event was reported as non-serious. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The outcome of event was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 included COVID test post vaccination (COVID test type post vaccination: Nasal Swab; COVID test name post vaccination: Color) on 29Dec2020 was negative. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Hypoaesthesia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 927519,MN,29.0,F,"Anaphylactic reaction; hives in the first 10 minutes of the vaccine; This is a spontaneous report from a contactable Other Health Professional (Physician Assistant). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she is treating a patient in ICU that got the COVID-19 vaccine on 29Dec2020. The patient developed hives in the first 10 minutes of the vaccine and had an anaphylactic reaction 1 hour later. Seriousness of events was reported to be hospitalization. Outcome of the events was unknown. The reporter also mentioned that it was not a mild reaction and patient was still in the ICU, 48 hours later. Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reaction and hives cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,12/29/2020,12/29/2020,0.0,UNK,,,,,,"['Anaphylactic reaction', 'Intensive care', 'Urticaria']",UNK,PFIZER\BIONTECH, 927520,,57.0,F,"Return of redness, itching, swelling at injection site one week after injection.; Return of redness, itching, swelling at injection site one week after injection; Return of redness, itching, swelling at injection site one week after injection; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Dec2020 at 07:30 (at the age of 57-years-old) as a single dose for Covid-19 vaccination. Medical history included Multiple Chemical Sensitivity (affecting my respiratory tract) from an unknown date. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 20:30, the patient experienced a return of redness, itching, swelling at injection site one week after injection. Therapeutic measures were not taken for the redness, itching, swelling at injection site. The clinical outcome of the events redness, itching, swelling at injection site was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/31/2020,8.0,UNK,,,Medical History/Concurrent Conditions: Multiple chemical sensitivity,,,"['Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site swelling']",UNK,PFIZER\BIONTECH, 927521,AL,52.0,F,"I shoulder pain in the joint.; This is a spontaneous report from a contactable other HCP, the patient. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899), via an unspecified route of administration on 31Dec2020 at 10:15 (at the age of 52-years-old) as a single dose, via intramuscular route of administration in the left arm for COVID-19 vaccination. Medical history was not reported. The patient had no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 18:00, the patient experienced l shoulder pain in the joint. The patient did not receive any treatment for the event. The clinical outcome of the l shoulder pain in the joint was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PVT,,,,,,['Arthralgia'],1,PFIZER\BIONTECH,OT 927522,,25.0,F,"Warmth of injection site; nausea; body aches; splitting headache; dizziness; Low grade fever; extreme tiredness; This is a spontaneous report from a contactable nurse, the patient. A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899), via an unspecified route of administration on 31Dec2020 at 10:00 (at the age of 25-years-old) as a single dose, in the right arm for COVID-19 vaccination. Medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), ibuprofen, paracetamol (TYLENOL), and fexofenadine, all from unknown dates for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin and famotidine, both from unknown dates to unknown dates for unknown indications, and experienced allergy. On 31Dec2020 at 17:00, the patient experienced warmth of injection site, body aches, splitting headache, dizziness, low grade fever, extreme tiredness, and nausea. The patient did not receive any treatment for the events. The clinical outcome of the events warmth of injection site, body aches, splitting headache, dizziness, low grade fever, extreme tiredness, and nausea was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,BENADRYL; ; ; TYLENOL,,,,,"['Body temperature', 'Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Vaccination site warmth']",1,PFIZER\BIONTECH, 927523,MD,60.0,F,"Sudden onset nausea; Swelling at injection site.; abdominal cramps; single episode loose stool; This is a spontaneous report from a contactable nurse, the patient. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140), via an unspecified route of administration on 30Dec2020 at 09:15 (at the age of 60-years-old) as a single dose, in the right arm for COVID-19 vaccination. Medical history included lymphedema, lipedema, depression, osteoporosis, osteoarthritis, hypothyroid, malabsortion with vitamin deficiencies, anemia, and allergy to latex. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, however it was reported the patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took thimerisol and influenza vaccine both from unknown dates to unknown dates for unknown indications and experienced allergy. On 30Dec2020 at 10:00, the patient experienced sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site. The patient did not receive any treatment for the events. The clinical outcome of the events sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Anemia; Depression; Hypothyroidism; Latex allergy; Lipedema; Lymphedema; Malabsorption; Osteoarthritis; Osteoporosis; Vitamin deficiency,,,"['Abdominal pain', 'Diarrhoea', 'Nausea', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 927524,,,F,"She tested positive PCR; She tested positive PCR; This is a spontaneous report from a contactable Nurse. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. Resident inoculated on 17Dec. She tested positive PCR on 29Dec2020. Currently in quarantine and asymptomatic. She was scheduled for dose 2 on 06Jan2021. This still fell in quarantine period. The nurse wanted to know if the patient could get the second dose on 06Jan, if not when should she get second dose. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 vaccine cannot be completely excluded for reported event ""test positive PCR"".",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/29/2020,12.0,UNK,,,,,,"['Quarantine', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 927525,KS,30.0,F,"shortness of breath/progressed until I went to urgent care; I started to really bad cough and then it actually got worse and worse; I was so weak like I am breastfeeding, I couldn't even hold my baby; extreme fatigue; I couldn't stay awake for more than a few hours at a time; Headache; lung problem; This is a spontaneous report from a contactable physician (the patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EH9899, via an unspecified route of administration on 16Dec2020 13:00 at single dose for COVID-19 immunisation. Medical history included history of reaction to mango (like face swelling and just a rash) and then gluten intolerant: if she eat it she doesn't have difficulty breathing. She never had problems with asthma in the past. The patient previously took BENADRYL for shortened like when she had a reaction with mango many years ago. In the past the patient had problems with cold and problems having bad cough that linger but she never needed Albuterol or steroids before. The patient had flu vaccine a month before, administered in deltoid left. The patient's concomitant medications were not reported. The patient experienced extreme fatigue on 19Dec2020 with outcome of recovering, shortness of breath/progressed until she went to urgent care on 21Dec2020 with outcome of recovering, She started to really bad cough and then it actually got worse and worse on 21Dec2020 with outcome of recovering, She was so weak like she was breastfeeding/She couldn't even hold her baby on 19Dec2020 with outcome of recovered on 20Dec2020, She couldn't stay awake for more than a few hours at a time on Dec2020 with outcome of unknown, headache on Dec2020 with outcome of unknown, lung problems on Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included chest x-ray: normal on unspecified date; SARS-COV-2 test: negative on 23Dec2020. The vaccine was administered at Hospital Facility. The patient was treated with steroids (20mg for 5 days) and an albuterol inhaler (2 puff every 4 hour). The events required visit to Emergency Room. The events were non serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/01/2020,,PVT,,,Medical History/Concurrent Conditions: Cold; Cough; Fruit allergy (like face swelling and just a rash); Gluten intolerance,,,"['Asthenia', 'Chest X-ray', 'Cough', 'Dyspnoea', 'Fatigue', 'Headache', 'Hypersomnia', 'Lung disorder', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 927526,MO,33.0,F,"Approximately 45 mins after receiving vaccine I felt like I was going to pass out. Laid down at home, heart racing. BP was 178/100 and HR 120 in supine. Drank juice on way to ED; Approximately 45 mins after receiving vaccine I felt like I was going to pass out. Laid down at home, heart racing. BP was 178/100 and HR 120 in supine. Drank juice on way to ED; Approximately 45 mins after receiving vaccine I felt like I was going to pass out. Laid down at home, heart racing. BP was 178/100 and HR 120 in supine. Drank juice on way to ED; This is spontaneous report from a contactable healthcare professional (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284), intramuscular at the right arm on 29Dec2020 07:15 at a single dose for COVID-19 immunization. Medical history included depression. No known allergies. The patient is not pregnant. No COVID prior vaccination. Facility type (vaccine) was hospital. No other vaccine in four weeks. Concomitant medications (in two weeks) bupropion hydrochloride (WELLBUTRIN XL), vitamin B complex, bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), ergocalciferol (VIT D), zinc and L-lysine. On, 29Dec2020 at 08:00, approximately 45 minutes after receiving vaccine she felt like she was going to pass out. Laid down at home, heart racing. BP was 178/100 and HR 120 in supine. The patient drank juice on way to emergency department and started feeling better about 1 hour later. The events resulted in emergency room/department or urgent care. No treatment for the events. The events were assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,WELLBUTRIN XL; ; PROBIOTIC [BIFIDOBACTERIUM LACTIS]; VIT D; ; L-LYSINE [LYSINE],,Medical History/Concurrent Conditions: Depression,,,"['Blood pressure increased', 'Blood pressure measurement', 'Heart rate', 'Palpitations', 'Presyncope']",1,PFIZER\BIONTECH,OT 927527,TN,68.0,F,"I tested positive for COVID 9 days after receiving the vaccine; I tested positive for COVID 9 days after receiving the vaccine; Rhinorrhea; aches; fatigue; cough; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the first of the two reports. A 68-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the left arm on 21Dec2020 at 09:30 at a single dose for COVID-19 immunization. Medical history included hypertension. The patient had no known allergies. Concomitant medications included losartan (LOSARTAN), amlodipine (AMLODIPINE), and atorvastatin (ATORVASTATIN). On 28Dec2020, the patient had rhinorrhea, aches, fatigue, and cough. The patient had no COVID prior vaccination, and when tested post vaccination showed a positive result. It was reported that the patient was tested via nasal swab (PCR SARS) and showed positive for COVID on 30Dec2020, 9 days after receiving the vaccine. The patient had no other vaccines in four weeks. No treatment was administered for the events. The events had not resolved. Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events drug ineffective and SARS-COV-2 test positive cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021001246 Same reporter, same drug, similar events, different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/28/2020,7.0,PVT,; ;,,Medical History/Concurrent Conditions: Hypertension,,,"['Cough', 'Fatigue', 'Pain', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 927528,FL,73.0,F,12:15 Client verbalize tightness with inhalation below the right breast. Client was evaluated by onsite paramedics and release to go home at 12:27 pm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,None,None,"HTN, GERD, Hyperlipidemia, Hepatitis, Astio valve replacement",,"Ambien, Codeine",['Chest discomfort'],1,PFIZER\BIONTECH,SYR 927529,CA,45.0,F,"Bilateral tinnitus (non-stop); This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 21Dec2020 at 10:15 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included chronic sinus infections in the past. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE), strength reported as 1/28, azelastine HCI nasal spray, montelukast sodium tablet. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 21Dec2020 at 12:00 (reported as since the vaccination), the patient experienced bilateral tinnitus (non-stop). The patient did not receive treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the bilateral tinnitus (non-stop) was not resolved. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,PVT,JUNEL FE; AZELASTINE HCL;,,Medical History/Concurrent Conditions: Sinus infection (Chronic sinus infections in the past.),,,['Tinnitus'],1,PFIZER\BIONTECH,OT 927530,NJ,50.0,F,RASH - NO TX YET INJECTION SITE SWELLING AT 10 POST INJECTION,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,PVT,"duloxetine, diltiazem, zyrtec, monteleukast,pantoprozale, metformin, spironolactone,",sinus issue,high blood pressure,,no none allergies,"['Injection site swelling', 'Rash']",1,MODERNA,IM 927531,MA,31.0,F,"Headache 24 hours after but nothing; uncontrollable/teeth chattering; chills; Fever; all over muscle aches; Injection site is sore and surrounding area is red; Injection site is sore and surrounding area is red; This is a spontaneous report from a contactable Other HCP. This 31-year-old female Other HCP (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date was not reported) on 30Dec2020 at 11:00 AM (at the age of 31-years) as single dose, Intramuscular into right arm for immunization. Medical history included COVID-19 virus test positive from 30Nov2020 to an unspecified date. Allergies were reported as none. Concomitant medications included magnesium citrate, magnesium oxide, riboflavin, tanacetum parthenium (MIGRELIEF) and curcuma longa rhizome, piper nigrum fruit (TURMERIC +). On 31Dec2020 (00:45), patient experienced headache 24 hours after vaccine but nothing to keep her from my normal activities. About 36-40 hours post vaccine on 01Jan2021 patient awoke with uncontrollable/teeth chattering chills with 101 Fahrenheit (F) fever and muscle aches. Fever broke after taking Tylenol severe. Temp at 5:30AM back down to 98.5F. Temp creeping up again to 99.5F at 11AM. Injection site is sore and surrounding area is red on 01Jan2021. The patient is experiencing all over muscle aches. The patient received treatment and controlled the fever with Tylenol. Lab data included body temperature 101, 98.5, 99.5 Fahrenheit all in Jan2021. Events 'Headache', 'teeth chattering', 'chills', 'fever', 'muscle pain', 'muscle pain' and 'Injection site is sore and surrounding area is red' were recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,MIGRELIEF; TURMERIC +,,Medical History/Concurrent Conditions: COVID-19,,,"['Body temperature', 'Chills', 'Headache', 'Myalgia', 'Pyrexia', 'Vaccination site erythema', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 927532,KS,35.0,F,"I am a healthcare worker and received the vaccine on 12/30/2020. Yesterday, 1/7/2020, I began noticing redness, swelling and itching around the injection site in my left deltoid. Today the redness has progressed to about a 1.5-2 inch diameter around the injection site. It is also mildly painful and swelling and itching have increased moderately.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2020,01/07/2021,365.0,OTH,Spironolactone 25 mg po daily Tri-lo sprintec 1 tab daily Multivitamin Melatonin 3 mg qhs,,None,,"Droperidol, (panick attack)","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 927533,IN,67.0,F,"sore at injection site; This is a spontaneous report from a contactable Other HCP. This 67-year-old female nurse (patient) received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported) on 30Dec2020 09:00 (at the age of 67-years) as single dose, unspecified route into left arm for immunization. Medical history included hypertension, depression, and hyperlipidemia. Known allergies: crestor, ANSAIDS, red dye, lavendar. Concomitant medications include hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), amlodipine (AMLODIPINE), bupropion hydrochloride (WELLBUTRIN), and atorvastatin calcium (ATORVASTATIN CALCIUM). Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 31Dec2020 at 6 AM the patient experienced 'sore at injection site'. No treatment was received as a result of the event. The outcome of event 'sore at injection site' was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,LISINOPRIL HCTZ; ; WELLBUTRIN;,,Medical History/Concurrent Conditions: Depression; Drug allergy; Hyperlipidemia; Hypertension,,,['Vaccination site pain'],UNK,PFIZER\BIONTECH, 927534,IN,34.0,M,"Twenty minutes after the vaccine was administered, I experienced nausea and vomiting. I was unable to tolerate food. The next morning and throughout the rest of the day, I had serious pain at the injection site, headaches, fatigue, dry throat, loss of appetite, persistent nausea, and dizziness. The fatigue, nausea, headache, and dizziness has currently persisted 2.5 days after I received the vaccine. This morning, 2.5 days after I received the vaccinne, I developed a cough.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Lisinopril, acetaminophen, hydrochlorothazide, vitamin D",,Hypertension,,Mushrooms,"['Cough', 'Decreased appetite', 'Dizziness', 'Dry throat', 'Fatigue', 'Food intolerance', 'Headache', 'Injection site pain', 'Nausea', 'Vomiting']",1,MODERNA,IM 927535,PA,58.0,F,Approximately 2 days after receiving the vaccination patient reported red petechial like rash beginning on her legs and spreading to abdomen and arms.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/23/2020,2.0,PVT,,,,,NKA,"['Haematocrit normal', 'Haemoglobin normal', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin normal', 'Mean platelet volume normal', 'Petechiae', 'Platelet count normal', 'Red blood cell count normal', 'Red blood cell sedimentation rate normal', 'Red cell distribution width normal', 'SARS-CoV-2 test negative', 'White blood cell count']",1,PFIZER\BIONTECH,IM 927536,IL,37.0,F,"Slight fever, 99.4, (ordinarily I run lower than normal), severe body aches, and chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Blood pressure medications, atorvastatin, Celebrex, enbrel, prednisone, thyroid med",None,"Rheumatoid arthritis, hypothyroid, hypertension and high cholesterol",,Allergy to amoxicillin,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 927537,MN,39.0,M,"Initial symptoms were fatigue, malaise, headache. Fever started sometime during the night, which was accompanied by chills and rigors. Fever at 0600 on 1/8/2021 was 105.7.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Multivitamin Zyrtec Pepcid Lisinopril,No,Hypertension,,No,"['Chills', 'Fatigue', 'Headache', 'Malaise', 'Pyrexia']",2,PFIZER\BIONTECH,IM 927538,NY,39.0,M,"My heart beat shot up from 72 to 116 within first few minutes of vaccination, I was having chills . It has been 8 days since I received the vaccine , my resting heart beat is still more than 100 BPM.; congested nose; I was having chills; extreme fatigue; This is a spontaneous report from a contactable Other HCP. This 39-year-old male Other HCP (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO140; Expiration date was not reported) on 24Dec2020 14:30 (at the age of 39-years) as single dose, unspecified route into left arm for immunization. Medical history was reported as none. Allergies were reported as none. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 24Dec2020 the patient experienced 'My heartbeat shot up from 72 to 116 within first few minutes of vaccination. It has been 8 days since I received the vaccine, my resting heartbeat is still more than 100 BPM', 'I was having chills', 'congested nose', and 'extreme fatigue'. No treatment was received as a result of the events. Lab data included on 24Dec2020 heartbeat 72 to 116 and Jan2021, reported as still more than 100 beats per minute. The outcome of events 'My heartbeat shot up from 72 to 116 within first few minutes of vaccination. It has been 8 days since I received the vaccine, my resting heartbeat is still more than 100 BPM', 'I was having chills', 'congested nose', and 'extreme fatigue' were not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No,,,"['Chills', 'Fatigue', 'Heart rate', 'Heart rate increased', 'Nasal congestion']",1,PFIZER\BIONTECH, 927539,FL,50.0,F,"Severe site pain, Severe stomach cramps, body aches (after 6 hours), vagovasal response, diarrhea, chills, fever, sweating (after 28 hours) Moderna COVID-19 Vaccine EUA",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Synthroid 100mcg, Mobic 15mg, vitamin b12, vitamin d 500mg",none,none,,"Latex, Composine, Shellfish","['Abdominal pain upper', 'Chills', 'Diarrhoea', 'Hyperhidrosis', 'Injection site pain', 'Pain', 'Presyncope', 'Pyrexia']",1,MODERNA,IM 927540,AZ,44.0,F,"Sore throat; cough; difficulty in breathing; tiredness; sleepiness; myalgia; arthralgia; headache; metallic taste in the mouth; burning in the eyes; chills; shaking; This is a spontaneous report from a contactable physician, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK5730) solution for injection on 24Dec2020 at 09:30 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no relevant medical history. There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Dec2020 at 07:00, the patient experienced sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking which lead to doctor or other healthcare professional office/clinic visit. Treatment was provided for the events sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking with NSAIDs. The outcome of the events sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking was not recovered. Since the vaccination, the patient has been tested for COVID-19 on 30Dec2020 via Nasal Swab and Antigen test and both were negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,WRK,,,,,,"['Arthralgia', 'COVID-19', 'Chills', 'Cough', 'Dysgeusia', 'Dyspnoea', 'Eye irritation', 'Fatigue', 'Headache', 'Myalgia', 'Oropharyngeal pain', 'Somnolence', 'Tremor']",1,PFIZER\BIONTECH, 927541,WV,36.0,F,"Sore arm began around 4:00pm, around 7:00pm I was developing body aches and a headache. By 9:00pm I had fever and chills and body aches all over. Fever and chills seemed to subside by 4:00am, headaches and body aches are still present but not as severe.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,SCH,None,COVID,None,,"Sulfa drugs, mango, poison Ivy","['Chills', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 927542,NY,62.0,F,"46 hours after receiving vaccine, experiencing twinges of moderate to severe headache and/or ear pain left side, similar to symptom experienced when I contracted Covid in Mar2020; 46 hours after receiving vaccine, experiencing twinges of moderate to severe headache and/or ear pain left side, similar to symptom experienced when I contracted Covid in Mar2020; This is a spontaneous report from a contactable healthcare professional, the patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK5730) solution for injection in the left arm on 30Dec2020 at 13:15 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included COVID-19 in Mar2020. Concomitant medications included atorvastatin, colecalciferol (VITAMIN D) and cetirizine. The patient no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19 in Mar2020. On 01Jan2021 at 10:30 (about 46 hours after receiving vaccine), the patient experienced twinges of moderate to severe headache and/or ear pain left side, similar to symptom experienced when I contracted Covid in Mar2020. No treatment was provided for the events ear pain and headache. The outcome of the events ear pain and headache was unknown. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/01/2021,2.0,PVT,; VITAMIN D [COLECALCIFEROL];,,Medical History/Concurrent Conditions: COVID-19,,,"['Ear pain', 'Headache']",1,PFIZER\BIONTECH, 927543,NY,58.0,M,"Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; This is a spontaneous report from a contactable nurse. A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, in left arm, on 30Dec2020 at 07:30 (at the age of 58 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a hospital. There was no medical history. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), celecoxib (CELEXA [CELECOXIB]), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), rosuvastatin calcium (CRESTOR). The patient did not receive any other vaccines in the 4 weeks prior to this vaccination and other medications (concomitant medications) were taken in the past 2 weeks. Prior to the vaccination, the patient had not been tested for COVID-19. On 30Dec2020 at 0745, the patient experienced dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site. The patient was not hospitalized for the events nor was treatment received. The clinical outcome of the events of dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site, was recovered on an unspecified date. After receiving the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,WELLBUTRIN; CELEXA [CELECOXIB]; ASPIRIN [ACETYLSALICYLIC ACID]; CRESTOR,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Chills', 'Dizziness', 'Headache', 'Nausea', 'Neck pain', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 927544,AZ,29.0,M,Nausea for 30 minutes in the middle of the night,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PUB,"Escitalopram 7.5mg/d, multivitamin, cetirizine 10mg/d",None,None,,Seasonal,['Nausea'],1,MODERNA,SYR 927545,MN,37.0,F,"exactly one day later I felt was feeling severe fatigue, nausea, headache at the base of my head and diarrhea for 1.5 days; exactly one day later I felt was feeling severe fatigue, nausea, headache at the base of my head and diarrhea for 1.5 days; exactly one day later I felt was feeling severe fatigue, nausea, headache at the base of my head and diarrhea for 1.5 days; exactly one day later I felt was feeling severe fatigue, nausea, headache at the base of my head and diarrhea for 1.5 days; This is a spontaneous report from a contactable health care professional nurse, the patient. A 37-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 30Dec2020 13:00 as a single dose for COVID-19 vaccination. The patient had no known medical history or allergies. Concomitant medication included sertraline hcl (ZOLOFT). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested . Facility where the most recent COVID-19 vaccine was administered was at a Hospital. On 31Dec2020 13:00, the patient experienced exactly one day later I felt feeling severe fatigue, nausea, headache at the base of my head and diarrhea for 1.5 days. No treatment was given for the events. The clinical outcome of feeling severe fatigue, nausea, headache at the base of my head and diarrhea was recovered. Information regarding lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,Zoloft,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Diarrhoea', 'Fatigue', 'Headache', 'Nausea']",1,PFIZER\BIONTECH,OT 927546,IL,29.0,F,Left axillary lymphedema (swollen under arm pit). Can?t sleep on that side or lay arm flat on that side. Right side is perfectly fine. Slight left neck swelling also. Significant injection site pain with mild redness and swelling. Joint/muscle pain. These events also occurred after my first covid Pfizer but not until day 4-5 and very mild. I have not taken any medication as of yet.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,No,No,No,Pfizer covid vaccine shot 1. Same as current ADE but less mild and delayed by 4-5 days,No,"['Arthralgia', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy', 'Myalgia', 'Swelling']",2,PFIZER\BIONTECH,IM 927547,VA,49.0,F,"Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; This is a spontaneous report from a contactable health care professional nurse, the patient. A 49-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899) in the left arm on 22Dec2020 14:30 as a single dose, for COVID-19 immunization. Medical history includes Lupus, Endometriosis, Epilepsy from an unknown date and unknown if ongoing. Concomitant medication included belimumab (BENLYSTA), prednisone (PREDNISONE), topiramate (TOPAMAX), levetiracetam (KEPPRA), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). The patient previously took Percocet [oxycodone hydrochloride; oxycodone terephthalate; paracetamol], Sulfa Drugs and hibiclens and experienced drug hypersensitivity. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient experienced sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea on 23Dec2020 07:00. Events continues through now 10 days later and still feel horrible. The events resulted in a physician office visit. The patient underwent lab tests that included SARS-CoV-2 test Nasal Swab (Both rapid and PCR) on 30Dec2020; influenza test and Streptococcus test on an unspecified date. The results of all laboratory tests influenza Streptococcus test and COVID (Both rapid and PCR) were negative. No treatment was received given for the events. The clinical outcome of sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,BENLYSTA; ; TOPAMAX; KEPPRA; VITAMIN D [ERGOCALCIFEROL],,Medical History/Concurrent Conditions: Endometriosis; Epilepsy; Systemic lupus erythematosus,,,"['Arthralgia', 'Chest discomfort', 'Diarrhoea', 'Fatigue', 'Headache', 'Investigation', 'Nausea', 'Neck pain', 'Oropharyngeal pain', 'Pyrexia', 'SARS-CoV-2 test', 'Streptococcus test']",1,PFIZER\BIONTECH, 927548,ME,49.0,F,"Stated approximately 5 minutes after receiving vaccine she developed tingling of the tongue, itching to extremity the vaccine was administered in and experienced a initial metal taste that has since turned sour. Patient spoke with PCP and encouraged to not get the second dose of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Dysgeusia', 'Paraesthesia oral', 'Pruritus', 'Taste disorder']",1,MODERNA,IM 927549,AZ,55.0,F,"Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; hives on neck; This is a spontaneous report from a contactable health care professional nurse, the patient. A 55-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9844), intramuscular in the left arm on 20Dec2020 13:45 as a single dose, Lot number EK5730 for COVID-19 vaccination. Medical history included ongoing complex regional pain syndrome. The patient previously took Ceftiaxone, tizanidine, vancomycin, triamcinone, duloxetine and experienced drug hypersensitivity. Concomitant medication were taken within two weeks but details not provided. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 14:00 the patient experienced flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes. No treatment was given for the events. The clinical outcome Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,UNK,,Complex regional pain syndrome,,,,"['Eye pain', 'Flushing', 'Heart rate', 'Heart rate increased', 'Hyperhidrosis', 'Lip swelling', 'Paraesthesia', 'Pharyngeal swelling', 'Throat irritation', 'Urticaria']",1,PFIZER\BIONTECH,OT 927550,,24.0,M,"Mild erythema with complaints of itching at injection site 7 days after injection. Physician treated with Triamcinolone Acetonide 0.025%, Cream, Topical APPLY TO AFFECTED AREAS TOPICALLY TWICE A DAY FOR 2 DAYS",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,MIL,,,,,,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 927551,IL,47.0,F,"swollen supraclavicular lymph node; headache; chills; soreness to injection site for 2 days; This is a spontaneous report from a contactable nurse, reporting for a patient. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, via intramuscular on 22Dec2020 at 14:45 (at the age of 47 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included asthma, celiacs, and hypertension from an unknown date. The patient had known allergies to shellfish, latex, sulfa, Levaquin, Morphine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydrochlorothiazide, zyrtec, dicyclomine, ibuprofen, benadryl, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 23Dec2020, the patient experienced soreness to injection site for 2 days (23Dec2020 and 24Dec2020). On 26Dec2020 at 16:00, she started having chills and headache. On 27Dec2020 chills were to the point where she couldn't get warm. Shivering chills. She remained afebrile just bad chills for 2 days. On 28Dec2020, she noticed swollen supraclavicular lymph node to left clavicle area which was painful to touch and approximately quarter in size. It was not as painful today and swelling was starting to subside. The patient did not receive treatment for the events. The clinical outcome of soreness to injection site for 2 days was recovered on 25Dec2020. The clinical outcome for headache, chills, and swollen supraclavicular lymph node was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,HCTZ; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; DICYCLOMINE; ; BENADRYL,,Medical History/Concurrent Conditions: Asthma; Celiac disease; Hypertension; Latex allergy; Shellfish allergy; Sulfonamide allergy,,,"['Chills', 'Headache', 'Injection site pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,OT 927552,VA,35.0,F,"severe dizziness, chest palpitations, extreme muscle weakness, projectile vomiting- all x15 minutes, followed by fever of 101.1 after tylenol. general fatigue, headaches for rest of day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"severe dizziness, chest palpitations, extreme muscle weakness, projectile vomiting- all x15 minutes, followed by fever of 101.1 after tylenol. general fatigue, headaches for rest of day.",none,none,,nkda,"['Dizziness', 'Fatigue', 'Headache', 'Muscular weakness', 'Palpitations', 'Pyrexia', 'Vomiting projectile']",2,PFIZER\BIONTECH,IM 927553,ME,45.0,F,"approximately 15 minutes after the vaccine was administered I developed numbness in my tongue, metallic taste in mouth, and headache and a fullness feeling in ears. 1 and 1/2 hours later I developed neck pain and numbness in the left side of my face that lasted for 48 hours. Benadryl was taking for 2 days to help with the reaction. Day 3 after the vaccine symptoms seemed to resolve except for a slight feeling of numbness in left cheek but much better than first 2 days and almost gone completely.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,"Fish oil, multi vitamin, vitamin D, probiotic",No illnesses prior for last month,no none health issues,hives and swelling from TDAP approximately 7 years ago - Benadryl resolved the hives after one dose,NKA,"['Dysgeusia', 'Ear discomfort', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Neck pain']",1,MODERNA,SYR 927554,NY,27.0,F,"Got 1st shot at 1430 1/4/21. Was sent back to my unit (OR). At 1455 got full body flush followed by tingling lips, tight throat, trouble swallowing and SOB. No obvious signs of swelling of the lips. Used inhaler for SOB which helped marginally. After 1.5 hrs tingling in lips and flushed skin went away. Throat tightness and SOB still remained but weren't progressing so went home after my shift. Later that night around 2100 took 1 25mg Benadryl. Tightness in throat and SOB improved. The next morning 1/5/21, I reported to work for my shift. Tightness and SOB was manageable at this point. At 0800 the tightness in my throat, trouble swallowing and SOB got significantly worse. I was scrubbed into a surgery and had to call for a replacement so I could take Benadryl. I took 1 25mg tablet and 2 puffs of my inhaler and went back to my case. After the Benadryl and inhaler, the tightness in my throat and SOB became slightly more manageable. At 1240 the symptoms came back and I took another Benadryl and 2 puffs of my inhaler with slight relief of symptoms. Stayed the rest of my shift continuing my inhaler as needed and a Benadryl every 4 hrs. At 1600 I developed a headache at the front of my head above my eyes like a weight was sitting there. The next day when I woke up 1/6/21, the tightness in my throat, SOB and headache were worse so I had to call into work. The headache that morning had progressed to 7 out of 10 pain and the pain then included my neck where it attaches to the skull. At 0830 I called employee health and they advised my to go to an urgent care. I was checked over by a PA and was prescribed prednisone 40 mg for 5 days along with Benadryl every 4 hrs and inhaler as needed. I was also nasal swabbed for Covid. After taking the steroid, the headache and neck pain, tightness in throat went away. The SOB also improved. Currently taking the steroid, Benadryl (every 4 hrs) and inhaler 2 puffs as needed. Symptoms are mostly controlled. 1/7/21 tried to cut back the Benadryl to every 6 hrs. Noticed a huge difference in my breathing and had an increase in SOB so went back to every 4 hrs. 1/8/21 still taking steroid and Benadryl every 4 hrs and inhaler. SOB is worse today even with taking Benadryl. Have an appointment with my PCP to talk about getting the 2nd shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Prozac, Multivitamin",,"asthma, depression","PPD, redness and itching around injection site","Clindamycin, penicillin, gluten, dairy","['Dysphagia', 'Dyspnoea', 'Flushing', 'Headache', 'Impaired work ability', 'Neck pain', 'Paraesthesia oral', 'SARS-CoV-2 test negative', 'Throat tightness']",1,PFIZER\BIONTECH,IM 927555,FL,58.0,F,"Severe bodyache with joint pain severe (Knee pain and upper back), chills, headache but more pain in right side headache with right ear tinnitus, sometimes cough, runny nose and metal taste in mouth.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,none,none,Insulin insufficient,,"codeine, demerol, flagil, pcn ,eggplant and latex","['Arthralgia', 'Back pain', 'Chills', 'Cough', 'Dysgeusia', 'Headache', 'Pain', 'Rhinorrhoea', 'Tinnitus']",2,PFIZER\BIONTECH,IM 927556,WA,54.0,F,"I woke up 6 hours after the vaccine with significant swelling in my face; This is a spontaneous report from a contactable nurse, the patient. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL0140, via an unspecified route of administration on 29Dec2020 at 07:30 (at the age of 54 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergies to azithromycin and compazine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 29Dec2020, the patient stated she woke up 6 hours after the vaccine with significant swelling in her face. It did not affect her breathing. She took 50 mg Benadryl . The swelling was gone 4 hours later. The clinical outcome of swelling in her face was recovered on 29Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,['Swelling face'],1,PFIZER\BIONTECH, 927557,NJ,37.0,F,"patient presented with delayed localized reaction one week post reaction - redness, warmth, and pain to the touch. she did not report reaction after initial injection but this was a delayed reaction she is now experiencing. she did not take any medications to treat symptoms. she was advised to seek medical evalauation in the emergency room for this reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/07/2021,7.0,PVT,not known,no,no,,none,"['Erythema', 'Pain', 'Skin warm']",1,MODERNA,IM 927558,,25.0,F,"Injection site pain; sore arm; muscle aches; fatigue; fever; headache; This is a spontaneous report from a contactable consumer (patient herself). A 25-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EK9231, expiration date: unknown), via an unspecified route of administration on the left arm on 31Dec2020 at 15:45 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. The patient had no known allergies; no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jan2021, the patient experienced injection site pain, sore arm, muscle aches, fatigue, fever, and headache. The reporter assessed the events as non-serious. The patient did not receive any treatment for the events. The patient was recovering from all the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Fatigue', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 927559,NY,28.0,F,"Mouth sores; This is a spontaneous report from a contactable other healthcare professional, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot Number: Er9231, via an unspecified route of administration on 30Dec2020 at 09:00 (at the age of 28 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included herpes simplex virus 1 from an unknown date, and known allergies to some fruits and vegetables (mild itching), and Neosporin. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included Benzoyl peroxide and tretinoin face cream, and vitamin D, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 31Dec2020, the patient experienced mouth sores. Treatment was not received for the event. It was also reported that since the vaccination, the patient has been tested for COVID-19 using a nasal swab on 31Dec2020, with results of negative. The clinical outcome of mouth sores was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,; ; VIT D,,Medical History/Concurrent Conditions: Food allergy (known allergies: Some fruits and vegetables (mild itching)); HSV infection; Itching (known allergies: Some fruits and vegetables (mild itching)),,,"['SARS-CoV-2 test', 'Stomatitis']",1,PFIZER\BIONTECH, 927560,MD,27.0,M,"Symptoms: Chills, headache, nausea, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,MIL,,,,,,"['Chills', 'Fatigue', 'Headache', 'Nausea']",1,MODERNA,IM 927561,FL,,F,"She also complained of all the COVID signs and symptoms; She also complained of all the COVID signs and symptoms; left cervical, axillary, clavicular and periscapular lymphadenopathy; left arm and shoulder pain; left arm and shoulder pain; This is a spontaneous report from a contactable physician. An adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection, lot number was unknown, intramuscular in the left arm on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient is not pregnant. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that after receiving the Pfizer COVID-19 vaccine in the left deltoid, the patient experienced left cervical, axillary, clavicular and periscapular lymphadenopathy in Dec2020 with outcome of not recovered. She also complained of left arm and shoulder pain and all the COVID signs and symptoms in Dec2020 with outcome of not recovered. The onset was within a day of immunization. She has a history of COVID-19, she had Covid prior vaccination. It was unknown if the patient tested for Covid post vaccination. The onset date of the events was reported as Dec2020. The events was reported as non-serious and it was unknown if the patient received treatment for the events. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the suspected LOE, COVID 19 and other reported events due to temporal relationship. Of note, it is reported that the patient had a history of COVID-19, and she was diagnosed with COVID 19 infection prior to the vaccination. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics , counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: COVID-19 (She has a history of COVID-19),,,"['Injection site pain', 'Lymphadenopathy', 'Pain in extremity']",1,PFIZER\BIONTECH,OT 927562,OH,40.0,F,Rash and pain at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/06/2021,6.0,PVT,None,None,None,,NKDA,"['Injection site pain', 'Injection site rash']",1,MODERNA,IM 927563,MA,34.0,F,"Moderna COVID-19 Vaccine EUA- fever, chills, sweats, headache, nausea, pain in arm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,Junel,Covid-19,,,,"['Chills', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 927564,PA,56.0,M,"Have a sore, reddened throat with significant uvula swelling. Diminished sense of taste.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/07/2021,5.0,WRK,None,tested positive for Covid 19 on 12/3/2020 but remained asymptomatic,none,,None,"['Enlarged uvula', 'Hypogeusia', 'Oropharyngeal pain', 'Pharyngeal erythema']",1,PFIZER\BIONTECH,IM 927565,PR,52.0,F,"muscular and arthrosis pain over 3 days, occasionally severe pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,no,diabetes,no,,no,"['Myalgia', 'Osteoarthritis']",2,PFIZER\BIONTECH, 927566,MN,26.0,F,"a slight sore throat and cough with a slight fatigue; a slight sore throat and cough with a slight fatigue; body aches; chills; fatigue; mild fever; diarrhea; nausea; This a spontaneous report from a contactable nurse (patient). A 26-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EJI685, unspecified route of administration on 30Dec2020 15:45 (at the age of 26-years-old) as 1 single dose in the right arm for COVID-19 immunization. Medical history included Polycystic ovarian syndrome (PCOS) and anxiety. Concomitant medication included ascorbic acid (VITAMIN C) colecalciferol (VITAMIN D), zinc and birth control. The patient was allergic to sulfamethoxazole and trimethoprim (BACTRIM) antibiotics. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The next morning after receiving the vaccine the patient had full body aches, chills, fatigue, mild fever, diarrhea, and nausea. These all resolved within 24 hours as the next day (2nd day after vaccination). The patient felt much better, and only had a slight sore throat and cough with very slight fatigue.The full body aches, chills, fatigue, mild fever, diarrhea, nausea, a slight sore throat and cough with a slight fatigue did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events full body aches, chills, fatigue, mild fever, diarrhea, nausea, a slight sore throat and cough with a slight fatigue. Outcome of the events full body aches, chills, fatigue, mild fever, diarrhea, and nausea was recovered. Outcome of the events a slight sore throat and cough with a slight fatigue was recovering. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL];,,Medical History/Concurrent Conditions: Anxiety; Polycystic ovarian syndrome,,,"['Chills', 'Cough', 'Diarrhoea', 'Fatigue', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 927567,OH,34.0,F,Clavicular lymphadenophathy on the same side as the injection,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/08/2021,8.0,PVT,None,NONE,NONE,,NKDA,['Lymphadenopathy'],1,MODERNA,IM 927568,CA,59.0,M,"Tachycardia/HR going up to 140 /minute; Blood pressure went up to 157/94; This is a spontaneous report from a contactable physician (patient himself). A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration (left arm), on 21Dec2020 at 16:30, at a single dose, for COVID-19 immunization. Relevant medical history included coronary artery disease (CAD) prior percutaneous coronary intervention (PCI) in 2004. The patient has no known allergies. Concomitant medications in two weeks included aspirin, ramipril, ezetimibe, simvastatin (VYTORIN), vitamin D3, and diclofenac. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The vaccine was administered in the hospital. On 21Dec2020, within 3 minutes of receiving the vaccine (at 16:45), the patient developed tachycardia with heart rate (HR) going up to 140 /minute and blood pressure went up to 157/94. Heart rate returned to 90s within few minutes while his blood pressure slowly returned to baseline 134/84 after 2 hours. The patient did not receive treatment for the events. The patient recovered from the events on the same day (21Dec2020). Since vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,ASPIRIN [ACETYLSALICYLIC ACID]; ; VYTORIN; ; VITAMIN D3,,Medical History/Concurrent Conditions: Coronary artery disease; Percutaneous coronary intervention,,,"['Blood pressure increased', 'Blood pressure measurement', 'Heart rate', 'Tachycardia']",1,PFIZER\BIONTECH, 927569,MD,24.0,F,"Soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 24-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL1284, intramuscularly on 30Dec2020 (at the age of 24-years-old) as a 1 single dose in the left arm for COVID-19 immunization. Medical history included type one diabetic and celiac disease. The patient had a medical history of allergies to iodine, shellfish, seafood and fish. Concomitant medications was unknown. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On unspecified date, the patient experienced soreness at injection site. The soreness at injection site did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the event. Outcome of the event Soreness at injection site was recovered. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,,,PVT,,,Medical History/Concurrent Conditions: Celiac disease; Fish allergy; Iodine allergy; Seafood allergy; Shellfish allergy; Type I diabetes mellitus,,,['Vaccination site pain'],1,PFIZER\BIONTECH,OT 927570,PA,49.0,F,"Chills with goose bumps, headache, severe aches, weakness/fatigue which began ~ 7 hours after injection and progressively worsened over 24 hours, ~40 hours after injection symptoms were gone. -took advil, increase fluids and went to bed to sleep ~ 7 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,"Prilosec, Toprol, Vitamin D, Lipitor, Tramadol, Xanax",,"Undifferentiated Connective Tissue Disease, IC, mitral valve prolapse, GERD",Tetanus at age 4; mild seizures; high fever,"PCN, Tetanus, Inapsine","['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Pain', 'Piloerection']",1,PFIZER\BIONTECH,IM 927571,NY,21.0,F,"tested positive for Covid test; tested positive for Covid test; difficulty breathing; chills; fluctuating fever; nausea; weakness; weakness/extreme fatigue; loss of taste and smell; loss of taste and smell; muscle pain; cough; sore throat; nasal drip; dizziness; fast heartbeat; injection site pain; anxiety; crying; This is a spontaneous report from a contactable healthcare professional. This 21-year-old female patient reported for herself that she received BNT162B2 1st dose on 31Dec2020 10:00 AM intramuscular at left arm for COVID-19 immunisation. Medical history included known allergies: Penicillin and Covid-19. Concomitant therapy included BC as reported. The patient experienced difficulty breathing, chills, fluctuating fever, nausea, dizziness, weakness, fast heartbeat, tiredness, loss of taste and smell, muscle pain, injection site pain, anxiety, cough, sore throat, nasal drip, crying, extreme fatigue, Etc on 31Dec2020 at 06:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency. The patient was hospitalized for 1 day and received treatment included blood thinner rivaroxaban (XARELTO) and had 2 weeks quarantine. The patient had Covid prior to vaccination and tested positive for Covid test post vaccination on 01Jan2021. The outcome of the events was not resolved. Information on Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the suspected LOE, SARS-CoV-2 test positive and the other reported events due to temporal relationship. Of note, it is reported that the patient had history of COVID 19 infection prior to the vaccination. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/31/2020,12/31/2020,0.0,PHM,,,Medical History/Concurrent Conditions: COVID-19; Penicillin allergy,,,"['Ageusia', 'Anosmia', 'Anxiety', 'Asthenia', 'Chills', 'Cough', 'Crying', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Heart rate increased', 'Injection site pain', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Pyrexia', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 927572,OH,67.0,M,Severe myalgia for one week,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,,,,Flu Vaccine,NKDA,['Myalgia'],1,PFIZER\BIONTECH,IM 927573,OK,45.0,F,"typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting so sore I couldn't lift it; Within a few hrs I lost the ability to move it at all for a few hrs; overwhelmed with fatigue; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; nauseous; dizzy; No fever but I felt hot & flushed.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: Ek9231), via an unspecified route of administration on the right arm on 31Dec2020 09:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included lupus.The patient also had allergies to penicillin (PCN). It was also mentioned that the patient COVID twice (Mar2020 until 2020&Nov2020 until 2020). Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and bupropion hydrochloride (WELLBUTRIN). It was reported that the patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient reported that she had a very slight reaction after administration & took diphenhydramine (BENADRYL). She described that approximately at the 11-hour mark (31Dec2020 20:00), her arm was getting so sore and she couldn't lift it. Within a few hours, she lost the ability to move it at all. Also, she was getting overwhelmed with fatigue & she had a feeling that can best be described as the feeling of death entering my bones. Every bone hurt and her ribs were so sore she couldn't take deep breaths. The patient would wake up crying in pain & her pain tolerance was very high. She felt nauseous & dizzy and was the worst night of her life. She took acetaminophen (APAP) 1000mg & meloxicam 15mg that night with no relief. She narrated that she had COVID twice (Mar & Nov) & that night that she experienced; she would rather have COVID 1000 more times than ever have this pain she was in. It was also mentioned that she had no fever, but she felt hot & flushed. At the 23hour mark (01Jan2020 20:00), her symptoms became typical flu body aches which was 100% manageable & was a relief after what she had. It was mentioned that she still had terrible fatigue and couldn't do normal activity (in Jan2021). The patient was not sure if she will take the 2nd shot after this. Outcome of the event of fatigue was not recovered; unknown for ""couldn't do normal activity"" and recovering for the remaining events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,VYVANSE; WELLBUTRIN,,Medical History/Concurrent Conditions: COVID-19; Lupus syndrome; Penicillin allergy,,,"['Bone pain', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Hot flush', 'Loss of personal independence in daily activities', 'Musculoskeletal chest pain', 'Nausea', 'Pain', 'Vaccination site movement impairment', 'Vaccination site pain']",1,PFIZER\BIONTECH, 927574,TX,50.0,F,"10 hrs. after receiving the vaccine, I started getting chills followed by muscle pain. My eyes were burning. I went to bed under 3 blankets and couldn't get warm. 5 hours later, the chills went away, but the pain persisted. 3 hours later, I took tylenol for the pain and felt much better 1 hour later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"simvastatin, synthroid",none,none,,NKA,"['Chills', 'Eye irritation', 'Feeling cold', 'Myalgia']",2,PFIZER\BIONTECH,IM 927575,CO,45.0,M,"polyneuropathy; facet joint diagnosis/new left forefoot paresthesia; This is a spontaneous report from a contactable physician (patient). A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot EJ1685) at the first dose in left arm on 17Dec2020 12:45 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered at Doctor's office/urgent care. Medical history included ongoing back pain (thinking it was due to running/physical therapy overuse injury). No allergies to medications, food, or other products. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. It was reported that 20Dec2020 morning: new left forefoot paresthesia. no weakness. Patient thought this might be due to the back pain he had been watching for 3 months, thinking it was due to running/physical therapy overuse injury. On 21Dec2020 sports medicine physician evaluation. numbness was gone, facet joint diagnosis, MRI lumbar ordered (still pending). On 24Dec2020 9 pm, paresthesia both hands and feet, no weakness nor other symptoms those continued and were slightly worse on 27Dec2020 morning, including face/teeth. no other symptoms; 27Dec2020 afternoon: internal medicine physician evaluation, working diagnosis polyneuropathy. Neurologist appointment will be 07Jan2021, 2 hours before 2nd shot was scheduled. The patient had been tested for COVID-19 test type post vaccination: negative on 22Dec2020. No treatment for event. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of polyneuropathy and facet joint diagnosis/new left forefoot paresthesia due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including nerve conduction tests, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/21/2020,4.0,PVT,,Back pain,Medical History/Concurrent Conditions: Injury,,,"['Facet joint syndrome', 'Paraesthesia', 'Paraesthesia oral', 'Polyneuropathy', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 927576,GA,35.0,F,"Fever (101F), chills, nausea, myalgias, injection site soreness extending to shoulder and down to elbow, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Flonase, azelistine, zyrtec",None,Asthma,,Penicillin,"['Chills', 'Fatigue', 'Injection site pain', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 927577,NC,62.0,F,"Back pain; Muscles felt really tightened up and stiff when getting out of bed and throughout the day (worst complaint); slight nausea/nausea; slight fatigue; slight headache; slightly stiff neck; right arm pain; The muscles knot up under her rib cage/muscle tightness; This is a spontaneous report from a contactable other health care professional. A 62-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), intramuscularly in the left arm on 29Dec2020 at 06:30 at a single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis from an unknown date and unknown if ongoing. Concomitant medications included ergocalciferol (VIT D), levothyroxine (MANUFACTURER UNKNOWN); both taken for an unspecified indication from an unspecified date to an unspecified date. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergy from an unspecified date to an unspecified date, influenza vaccine (FLU VACCINE) for an immunization on an unspecified date (received within two weeks of vaccination). The patient experienced the following events and outcomes: muscles felt really tightened up and stiff when getting out of bed and throughout the day (worst complaint) (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight nausea/nausea (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight fatigue (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight headache (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slightly stiff neck (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, right arm pain (non-serious) on 30Dec2020 with outcome of unknown, back pain (non-serious) on 31Dec2020 with outcome of unknown, the muscles knot up under her rib cage/muscle tightness (non-serious) in Dec2020 with outcome of unknown. The patient received the COVID-19 vaccine on 29Dec2020 at work, and she had been experiencing adverse events since. The worst side effect she was experiencing was muscle tightness. At the time of the report, the patient got up at 09:00, and her ""back was killing her."" The patient was achy. The patient would tighten up really tight under both rib cages, and it made her nauseous. The patient had been taking ibuprofen (ADVIL) and ibuprofen (MANUFACTURER UNKNOWN since she received the vaccination. The patient received the vaccine in her left arm, but her right arm hurt the next day. The next day after that (30Dec2020) she woke up and the right side of her back around the kidney area hurt. It was the right side lumbar. The next morning after that, ""her entire back was killing her down the middle of her spine. From her head all the way down."" Since then, it came and went. The patient could not say if it was persisting, improving or worsening for any of the symptoms. ""It just grabs her."" The day before the report, the patient thought she was doing better. The patient cleaned the house, and then sat down to eat. The past two nights, it had ""hit her really hard during supper time."" Both of her sides of her back would tighten up; ""tense up like waiting for an impact before a wreck."" The patient's back would seize up. The patient could not get comfortable; and would start pacing. Then, she would try to lay down. Last night, it took a half an hour to loosen back up. ""It knots up like crazy. It was bad enough, she thought she was going to pass out."" The patient did not know if it was the combination of eating supper or what. The patient thought if she got up that maybe she would feel better. The patient started pacing around. The patient went outside because she thought maybe fresh air would help. When it would tighten up under her rib cage, it made her nauseous. The patient did not know if it was a ""vagus nerve thing or what."" The patient was close to throwing up. The muscles knot up under her rib cage. The patient's back felt like she fell off a horse. It was weird to her that her left arm never bothered her. ""Nothing stays the same."" Sometimes it was her entire arm or part of the arm that hurt. Like on top of her forearm. The patient thought she was doing good and then it would come back. When she moved her arm upward, she felt it. The patient said she could deal with the arm pain. It was the knotting up pains that were the worst. The patient tried calling an institute (name withheld) because it happened while eating dinner the other night. The institute (name withheld) ""nurse was useless."" The pain was across her sacroiliac area. The patient had been ""living on Advil and ibuprofen for her back pain."" The patient had been taking them together. The patient worked nights, and she was planning on going to work the night before the report, but she had to text her boss and tell her she could not come in. The patient was in good health; had perfect blood pressure and her sugar was normal. The patient was not diabetic. The patient's labs were always normal. The patient was really dreading that second shot. ""The flu shot kicked her butt for a couple of days, but this was way worse."" The patient started reading up on the COVID vaccine, and it said usually younger people had severe side effects. That old people have less of a response. The patient did not know why she was experiencing such side effects. At the time of the report, it was day 7 or 8, and she was still feeling bad. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/01/2020,,PVT,VIT D;,,Medical History/Concurrent Conditions: Hashimoto's thyroiditis,,,"['Back pain', 'Blood glucose', 'Blood pressure measurement', 'Fatigue', 'Headache', 'Investigation', 'Muscle discomfort', 'Muscle tightness', 'Musculoskeletal stiffness', 'Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH,OT 927578,OH,57.0,F,arm more sore than first shot; diarrhea- mild,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,none,none,mild asthma migraine,,none,"['Diarrhoea', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 927579,NY,67.0,F,"Dizziness when getting up after lying down. Did not have prior to receiving the vaccine. It continues to occur every day.; This is a spontaneous report from a non-contactable nurse (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Eh9899/expiration date unknown), via intramuscular route of administration, on 24Dec2020 at 07:15 AM (at the age of 67 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included hypertension and known allergies to chocolate, strawberries. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Ramipril, Atorvastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Ramipril, Atorvastatin within 2 weeks of vaccination. On 25Dec2020, at 07:00 AM, the patient experienced dizziness when getting up after lying down which she did not have prior to receiving the vaccine. It continues to occur every day. No treatment was received for the event dizziness when getting up after lying down. The outcome of the event dizziness when getting up after lying down was not recovered. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,PVT,;,,Medical History/Concurrent Conditions: Food allergy; Hypertension,,,['Dizziness postural'],1,PFIZER\BIONTECH, 927580,,,F,"fever; cough; cold; body aches; This is a spontaneous report from a contactable nurse, the patient. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ), via an unspecified route of administration on 22Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, over a week after the patient received the vaccine, the patient started to develop symptoms of fever of a 100.9 degrees Fahrenheit, cough, cold, and body aches. She reported that her husband was sick and had similar symptoms on 31Dec2020. The clinical outcomes of the fever of 100.9 degrees Fahrenheit, cough, cold, and body aches were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,UNK,,,,,,"['Body temperature', 'Cough', 'Nasopharyngitis', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 927581,CT,36.0,F,"In addition to my first report, I want to add: Pain and soreness in my left armpit/breast area since 12/25 that started mild and is moderately sore and painful. It seems to be getting worse.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/25/2020,2.0,OTH,"Beep, Montelukast, Nasal Spray, Claratin, Glucosamine, Calcium",None,Asthma and Allergies,,"Penicillin, Lactose, Tree Pollen, Dust, Pet Dander","['Axillary pain', 'Breast pain']",1,PFIZER\BIONTECH,SYR 927582,MO,34.0,F,"Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EH9899, expiration date: unknown), intramuscularly on the left arm on 31Dec2020 at 11:00 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. The patient had no known allergies; no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jan2021, the patient experienced left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection. The reporter assessed the events as non-serious. The patient did not receive any treatment for all the events. The patient was not recovered from the events ""left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection.""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Vaccination site erythema', 'Vaccination site hyperaesthesia', 'Vaccination site induration', 'Vaccination site pain', 'Vaccination site swelling', 'Vaccination site warmth']",1,PFIZER\BIONTECH,OT 927583,CA,48.0,F,"19Dec2020 100 degree temp - self resolved/fever; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 48-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) intramuscular (left arm) on 18Dec2020 at 11:30, at a single dose, for COVID-19 immunization. Relevant medical history included psoriasis. Concomitant medications included unspecified vitamins and herbal supplements. The patient previously received gluten and penicillin and experienced allergies. Patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive other vaccines 4 weeks prior vaccination. The vaccine was administered in the hospital. The patient received the vaccine on 18Dec2020. On 19Dec2020, at 19:00, the patient had 100-degree temperature (self-resolved). On 24Dec2020, the patient had a 101 fever which was resolved with Tylenol. The patient had fever of 102.1 on 30Dec2020, 101.4 on 31Dec2020, 102.8 on 01Jan2021, and 101.9 on 02Jan2021 which were not resolved with Tylenol. Outcome of the event was not recovered. Since vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/19/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy; Psoriasis,,,"['Body temperature', 'Pyrexia']",1,PFIZER\BIONTECH,OT 927584,VA,43.0,F,"Patient develops mild hives and flushing of the neck and face approx. 1 hour after receiving dose #1 of the Pfizer-BioNTech COVID-19 vaccine. She self-ambulated to the clinic where she was assessed, vitals taken (which were stable), and offered an injection of Benadryl 25mg IM, which she accepted. Patient was continually monitored and reassessed 15, 30, and 60 minutes after her arrival at which time she was starting to feel better, less flushed, with a visible reduction in her mild hives. Patient was released to her own self-care and stated she would be calling her husband to pick her up from work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,MIL,,,,,Sulfa,"['Flushing', 'Urticaria']",1,PFIZER\BIONTECH,IM 927585,IL,45.0,F,"My arm where I received the shot is now hurting more and I can't lift my arm up out in front of me are straight up in the air.; My arm where I received the shot is now hurting more and I can't lift my arm up out in front of me are straight up in the air.; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) via an unspecified route of administration (right arm), on 18Dec2020 at 06:15 a.m., at single dose, for COVID-19 immunization. The patient has no relevant medical history. Concomitant medications included vitamins and calcium chews (one a day) and cetirizine hydrochloride (ZYRTEC). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccine four weeks prior vaccination. The vaccine was administered in the hospital. On 01Jan2021, the arm where patient received the shot was now hurting more. Patient can't lift her arm up out in front of her and straight up in the air. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,01/01/2021,14.0,PVT,ZYRTEC,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Joint range of motion decreased', 'Vaccination site pain']",1,PFIZER\BIONTECH, 927586,VA,28.0,F,"Some nausea; Got a pulsating headache; Shortly after receiving the vaccine I felt a flushed feeling in my cheeks.; My left arm also was extremely hard, sore, and tender/swollen.; My left arm also was extremely hard, sore, and tender/swollen.; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), intramuscular on 22Dec2020 16:00 at single dose at arm (for confirmation) for COVID-19 immunization. Medical history included anxiety. The patient's concomitant medications were not reported. On 22Dec2020 17:00, Shortly after receiving the vaccine the patient felt a flushed feeling in her cheeks. The patient's left arm also was extremely hard, sore, and tender/swollen. About an hour afterwards, 18:00 I got a pulsating headache that lasted for 3 days. It was only mildly relieved with Tylenol and ibuprofen. It felt similar to a migraine and accompanied with some nausea on 23Dec2020 day 2. The patient received treatment for the events. The outcome of the events was recovered on an unspecified date in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Anxiety,,,"['Flushing', 'Headache', 'Nausea', 'Pain in extremity', 'Peripheral swelling']",1,PFIZER\BIONTECH,OT 927587,MD,26.0,F,Paresthesia's throughout arms and legs over the last few days. 25 minutes after shot I had severe pins and needles (falling asleep sensation) in my left leg. Progressed to numbness/squeezing sensation in my left lower leg and numbness in L hamstring throughout the rest of the day. Wednesday I had numbness/squeezing sensation in both of my lower legs and feet and numbness throughout both hamstrings and quads. Wednesday night I had numbness throughout my right forearm after my legs started to improve slightly. Thursday I had less consistent numbness throughout my legs and forearms though still present and started getting tingling into my left hand. This morning (Friday) I have tingling occasional tingling into my lower legs and left hand.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,UNK,,,,,Ceclor,"['Hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 927588,GA,50.0,M,"Sore arm for day and a half; onset of chills, body aches, low grade fever.; onset of chills, body aches, low grade fever.; onset of chills, body aches, low grade fever.; This is a spontaneous report from a contactable nurse (patient). A 50-year-old male patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0142), via an unspecified route of administration on the right arm on 31Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital. There were no concomitant medications. It was reported that the patient was the patient diagnosed with COVID-19 prior to vaccination on 12Dec2020 (pending clarification). On 31Dec2020 22:00 (approximately 14 hours after vaccination), the patient had a sore arm for day and a half and onset of chills, body aches, low grade fever were noted. It was mentioned that the symptoms were treated with acetaminophen (TYLENOL) and ibuprofen. The patient was not tested for COVID-19 since the vaccination. The patient recovered from sore arm on 02Jan2021 10:00 (day and a half) and from the remaining events on 01Jan2021 14:00 (lasted for approx. 16 hours off/on).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,Medical History/Concurrent Conditions: COVID-19,,,"['Chills', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH, 927589,GA,36.0,F,"sore arm immediately. then 10 hours after the shot, chills, headache, and back pain followed by fever up to 104.7, abdominal pain, nausea and vomiting, myalgia, and cough.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,tylenol 650mg at 110am and then ibuprofen 600mg at 220am.,none,"asthma, seasonal allergies, eczema, migraines, IBS",,lamotrigine,"['Abdominal pain', 'Back pain', 'Chills', 'Cough', 'Headache', 'Myalgia', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,SYR 927590,,72.0,F,"she experienced signs and symptoms of allergic reactions which was progressing; fever; body ache; tired; feels like she doesn't have enough energy; dry cough; This is a spontaneous report from a contactable nurse. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 30Dec2020, the patient experienced signs and symptoms of allergic reactions which was progressing. Mentioned that she had fever, fever with temperature ranging from 98.7�F-102.2�F, body ache, tired and feels like she doesn't have enough energy, dry cough. Wants to know how long does the symptoms last. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/30/2020,2.0,UNK,,,,,,"['Asthenia', 'Body temperature', 'Cough', 'Fatigue', 'Hypersensitivity', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 927591,KS,38.0,F,"Chills; Aches; Sweating; Dyspnea; Wheezing; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in left arm, on 21Dec2020, at a single dose, for COVID-19 immunization. The patient had no medical history and no concomitant medications. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 21Dec2020, the patient experienced chills, aches, sweating, dyspnea, wheezing, and fatigue. The events are considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Dyspnoea', 'Fatigue', 'Hyperhidrosis', 'Pain', 'Wheezing']",1,PFIZER\BIONTECH, 927592,UT,61.0,F,"Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) solution for injection via an unspecified route of administration on left arm on 22Dec2020 02:30 at a single dose for Covid-19 immunization. Medical history included CREST Syndrome, type 2 diabetes, osteoarthritis, allergies to Sulfa and Dermabond tape. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergy. The patient took other medications in the last two weeks. On 26Dec2020, the patient experienced average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also, she experienced achiness, and tiredness on 26Dec2020. No treatment received for the events. The patient was not diagnosed with Covid-19 and has not been tested prior to vaccination. Outcome of the events was unknown. No follow-up activities are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/26/2020,4.0,PVT,,,Medical History/Concurrent Conditions: Adhesive tape allergy; CREST syndrome; Osteoarthritis; Sulfonamide allergy; Type 2 diabetes mellitus,,,"['Blood glucose', 'Blood glucose increased', 'Fatigue', 'Pain']",1,PFIZER\BIONTECH, 927593,TN,38.0,F,"Headache; She was pregnant at the time of vaccination; She was pregnant at the time of vaccination; She was pregnant at the time of vaccination; This is a spontaneous report from a contactable nurse (patient). A 38-year-old pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) solution for injection, via an unspecified route of administration on left arm on 01Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included diabetes, and depression. Concomitant medications included escitalopram oxalate (LEXAPRO), ascorbic acid, biotin, minerals NOS, nicotinic acid, retinol, tocopherol, vitamin b NOS, vitamin D NOS (PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS]), progesterone (PROGESTERONE), and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient reported she was pregnant at the time of vaccination on 01Jan2021 15:00. She was at 9 weeks gestational period and will be due to deliver on 01Aug2021. The patient experienced headache on 02Jan2021 16:00 but did not receive any treatment. Outcome of the event headache was recovering while for the other event was unknown. No follow-up activities are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,PVT,LEXAPRO; PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS; ; VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: Depression; Diabetes,,,"['Headache', 'Maternal exposure during pregnancy', 'Off label use', 'Product use issue']",1,PFIZER\BIONTECH, 927594,TX,36.0,M,"left eyelid began to twitch and to this day has been off and on everyday; This is a spontaneous report from a contactable healthcare professional. A 36-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) solution for injection, intramuscular on left arm on 18Dec2020 08:00 at a single dose for COVID-19 immunization. Medical history included seasonal allergies. Concomitant medication included liothyronine. On 19Dec2020 at 23:00, patient reported his left eyelid began to twitch and up to this day it has been off and on everyday. No treatment was given. The event was reported as non-serious. The patient was not diagnosed of Covid-19 prior to vaccination and has not been tested for Covid-19 since vaccination. Outcome of the event was unknown. No follow-up activities are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/19/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Seasonal allergy,,,['Blepharospasm'],1,PFIZER\BIONTECH,OT 927595,PA,44.0,F,"Increased left hand pain. More pain than typical arthritis pain; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration at the left arm on 30Dec2020 17:00 at a single dose for COVID-19 immunization at a hospital. Medical history included ventricular septal defect (VSD), psoriasis, inflammatory arthritis, and migraines. Concomitant medications included fish oil, magnesium, paracetamol (TYLENOL ARTHRITIS). The patient previously took naproxen and experienced allergies. The patient experienced increased left hand pain that was more pain than typical arthritis pain on 31Dec2020, 12:00. The patient did not received any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient has not recovered from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,; ; TYLENOL ARTHRITIS,,Medical History/Concurrent Conditions: Inflammatory arthritis; Migraine; Psoriasis; VSD,,,['Pain'],1,PFIZER\BIONTECH, 927596,NJ,30.0,M,"The patient complained of dizziness, itching, immense sweating within one hour of the vaccine administration. Over the next 12-24 hrs the patient had bloody emesis, diarrhea and noticeable swelling of tongue/lips.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,MIL,None reported,None reported,Unknown,,NKA,"['Diarrhoea', 'Dizziness', 'Haematemesis', 'Hyperhidrosis', 'Lip swelling', 'Pruritus', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 927597,MT,47.0,F,"rash dots on back of both hands/rash on shoulders and mid-back/rash on upper legs/rash on lower legs and arms; This is a spontaneous report received from a contactable nurse (who is also the patient). A 47-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EH9899), intramuscular in left arm, on 17Dec2020 13:00, at single dose, for COVID-19 immunization. Medical history included ulcerative colitis diagnosed in 2002, and ""Allergies to medications, food, or other products: Sulfa medications - cause rash"". The patient is not pregnant. Concomitant medication included mesalamine, lithium, lamotrigine and an unspecified birth control pill. It was reported that on 23Dec2020 15:00 (also reported as 17:00, pending clarification), she noticed rash dots on back of both hands. On 26Dec2020 15:00, she noticed rash on shoulders and mid-back. On 28Dec2020 17:00, she noticed rash on upper legs. On 29Dec2020 17:00, she noticed rash on lower legs and arms. On 01Jan2021, she went to urgent care for evaluation and was treated with methylprednisolone dose pack. The patient did not receive any other vaccines with 4 weeks prior to BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovering. The reporter assessed the report as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/23/2020,6.0,PVT,MESALAMINE; ;,,Medical History/Concurrent Conditions: Drug allergy; Rash; Ulcerative colitis (diagnosed in 2002),,,['Rash'],1,PFIZER\BIONTECH,OT 927598,,51.0,M,"got COVID-19 from his son and tested positive; got COVID-19 from his son and tested positive; This is a spontaneous report from a contactable physician. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got COVID-19 from his son and he tested positive 31Dec2020. The patient's son got the COVID-19 virus on 20Dec202020. The patient is due to have 2nd vaccine on 07Jan2021. Outcome of the events was unknown. Information on batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/01/2020,,UNK,,,,,,"['COVID-19', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 927599,MI,35.0,F,"Chills, muscle pain, headache, pain at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Headache', 'Injection site pain', 'Myalgia']",1,PFIZER\BIONTECH,SYR 927600,OK,26.0,F,"Arm pain at injection site; fever of 101; chills; severe body aches; mild headache; nausea; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot numbe: EK5730), via an unspecified route of administration on the left arm on 31Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included anxiety, and covid prior vaccination: Yes. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. The patient experienced arm pain at injection site, fever of 101, chills, severe body aches, mild headache, nausea on 01Jan2021. The patient received no treatment. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,ZOLOFT,,Medical History/Concurrent Conditions: Anxiety; COVID-19,,,"['Body temperature', 'Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Vaccination site pain']",2,PFIZER\BIONTECH, 927601,MI,43.0,F,"Pain on injection site in couple of days; tiredness; headache; muscle pain; joint pain; weakness; mild fever; sore throat; profused sweating; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EL0140, expiration date unspecified), via an unspecified route of administration on 29Dec2020 10:30 at single dose at left arm, for COVID-19 immunization. Medical history included allergies to seafoods occasionally. There were no concomitant medications. The patient was not pregnant at the time of vaccination. On 31Dec2020 23:00, the patient experienced pain on injection site in couple of days, tiredness, headache, muscle pain, joint pain, weakness, mild fever, sore throat and profuse sweating. Therapy for the events included Tylenol 500 mg. It was reported that the patient was vaccinated at the hospital. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. The patient underwent a lab test and procedure which included nasal swab which was negative on 11Nov2020. Outcome of events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/31/2020,2.0,PVT,,,"Medical History/Concurrent Conditions: Seafood allergy (Allergies to medications, food, or other products: Seafoods occasionally)",,,"['Arthralgia', 'Asthenia', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Oropharyngeal pain', 'Pyrexia', 'SARS-CoV-2 test', 'Vaccination site pain']",1,PFIZER\BIONTECH, 927602,NV,68.0,F,"Lip tingle; Tongue- back, Each side-felt full; Eye lids dropped; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 68-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand Pfizer, lot EK5730, expiry date not reported), intramuscular in the left arm on 21Dec2020 16:15 at single dose, for Covid-19 immunisation. Medical history included asthma. Prior to vaccination the patient was not diagnosed with COVID-19. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included liothyronine, levothyroxine sodium (LEVOXYL), ergocalciferol (VIT D) and fluticasone propionate (FLOVENT). The patient experienced lip tingle, tongue- back, each side-felt full, eye lids dropped on 21Dec2020 16:15. He went to professional office/clinic visit/Emergency room/department or urgent care. An unknown treatment was given to the patient. The outcome of events was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,WRK,; LEVOXYL; VIT D; FLOVENT,,Medical History/Concurrent Conditions: Asthma,,,"['Eyelid disorder', 'Glossitis', 'Paraesthesia oral']",1,PFIZER\BIONTECH,OT 927603,CO,34.0,F,"Near syncope; lightheaded/dizzy; vision narrow; Tingling in lips; This is a spontaneous report from a contactable physician. A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), via an unspecified route of administration on 20Dec2020 09:00 in left arm at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient experienced near syncope, lightheaded, dizzy, vision narrow and tingling in lips on 20Dec2020 09:30 AM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment given to the patient for the events. The outcome of the events was recovered on unspecified date. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dizziness', 'Paraesthesia oral', 'Presyncope', 'Visual impairment']",1,PFIZER\BIONTECH, 927604,MN,,F,"R knee pain and effusion 1 week after receiving the vaccine; R knee pain and effusion 1 week after receiving the vaccine; This is a spontaneous report from a contactable physician. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0104), intramuscular at the left arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization at a hospital in an emergency room/department or urgent care. Medical history included hypothyroidism, allergies with sulfa. The patient's concomitant medications were not reported. The patient experienced right knee pain and effusion 1 week after receiving the vaccine on 30Dec2020, 06:00. The patient an unspecified NSAIDS as a treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient has not recovered from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PVT,,,Medical History/Concurrent Conditions: Hypothyroidism; Sulfonamide allergy,,,"['Arthralgia', 'Joint effusion']",1,PFIZER\BIONTECH,OT 927605,IL,28.0,M,"Coughing; This is a spontaneous report from a contactable other healthcare professional. A 28-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration on 02Jan2021 12:00 single dose (left arm, dose 1) for COVID-19 immunization. Medical history included bipolar disorder from an unknown date. No other vaccine in four weeks was given. Patient took other unspecified medications in two weeks. The patient has no COVID prior vaccination. The patient was not tested for COVID post vaccination. Patient has no known allergies. The patient experienced coughing on 02Jan2021 12:30 with outcome of not recovered. Treatment was not given. The reporter considered the event as non-serious. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PHM,,,Medical History/Concurrent Conditions: Bipolar disorder,,,['Cough'],1,PFIZER\BIONTECH, 927606,IL,43.0,F,"Temporary blurred vision; increased her nearsightedness from -1.25 to -1.75; corneal edema/ Corneal topographies showed swelling in the cornea; This is a spontaneous report from a contactable other healthcare professional. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140), intramuscular (left arm, dose number 1) on 01Jan2021 16:45 at single dose for COVID-19 immunization. Medical history included known allergies to penicillin and sulfa antibiotics, hormonal migraines, and gluten intolerance from an unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC), and spironolactone from unspecified dates for unspecified indications taken within two weeks. No other vaccine was taken within four weeks. Patient has not COVID prior vaccination. Patient has not been tested for COVID post vaccination. The patient experienced temporary blurred vision in the right eye on 02Jan2021. Patient stated that she is an optometrist so she performed a variety of tests and determined she had corneal edema. Corneal topographies showed swelling in the cornea, increased her nearsightedness from -1.25 to -1.75. By the time she left work 7 hours later, her vision and corneal topographies returned back to normal. Treatment was not given for the events. Event outcome was recovered on 02Jan2021. The reporter assessed the event was non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/02/2021,1.0,PHM,ZYRTEC [CETIRIZINE HYDROCHLORIDE];,,Medical History/Concurrent Conditions: Gluten intolerance; Migraine; Penicillin allergy; Sulfonamide allergy,,,"['Corneal oedema', 'Myopia', 'Topography corneal', 'Vision blurred']",1,PFIZER\BIONTECH,OT 927607,NV,23.0,F,"Sore arm where vaccination was administered; Intermittent nausea; Increased heart rate; anxiety; Tiredness; This is a spontaneous report from a contactable nurse (Patient). A 23-year-old female patient received the first dose of bnt162b2 (PFIZER COVID 19 VACCINE, lot number: EH9899, Batch/lot number: EK5730 as reported), via an unspecified route of administration at Right arm on 16Dec2020 17:00 at a single dose for COVID-19 immunization. Medical history included General Anxiety Disorder, depression, and COVID-19. The patient had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), levonorgestrel (NORTREL[LEVONORGESTREL]). The patient experienced sore arm where vaccination was administered, intermittent nausea for 3 days, increased heart rate and anxiety for 1.5 days, and tiredness; all on 16Dec2020. There was no treatment for the adverse events. The patient did not test positive for COVID post vaccination. The event Nausea recovered in 19Dec2020, while patient recovered from the other events in Dec2020. The vaccine was administered at the hospital. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were considered as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,PVT,LEXAPRO; NORTREL [LEVONORGESTREL],,"Medical History/Concurrent Conditions: Anxiety disorder (General Anxiety Disorder); COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?:Yes); Depression",,,"['Anxiety', 'Fatigue', 'Heart rate', 'Heart rate increased', 'Nausea', 'Vaccination site pain']",1,PFIZER\BIONTECH, 927608,HI,36.0,F,"vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; It appears I have eye shadow; peeling/dryness of skin around lips; peeling/dryness of skin around lips/It appears I have eye shadow but peeling is not visible; burning and itch of lip region; burning and itch of lip region; muscle spasm; Neuralgia; medium-severe headache; nausea; sensitive to light; mild confusion; lack of concentration; This is a spontaneous report from a contactable nurse (patient herself). A 36-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), intramuscular in 28Dec2020 08:30 at a single dose in the left arm as COVID vaccine. Medical history included history of Grave's disease at age 19 which has resolved without medication for many years. The patient had no known allergies: no allergies to medications, food, or other products. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient had no other vaccine in four weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not taking any daily medications. On 28Dec2020 (day 1), patient had no significant symptoms. On 29Dec2020 (day 2), patient had medium-severe headache, nausea, sensitive to light, mild confusion and lack of concentration. On 30Dec2020 (day 3), patient had muscle spasm that wake from a sound sleep in biceps tendon region, and neuralgia in left upper and lower extremities. On 31Dec2020 (day 4), patient had peeling/dryness of skin around lips, burning and itch of lip region. On 01Jan2021 (day 5), patient had post vaccination burning, itching redness to eye lids. Patient realized patient should photo her journey. It appeared patient have eye shadow but peeling was not visible due to moisturizer and bacitracin ""ito"" try and sooth the pain. Patient can send at additional request since patient can't upload. The patient was not tested for COVID post vaccination. Therapeutic measures were taken as a result of the event ""peeling/dryness of skin around lips/it appeared patient have eye shadow but peeling was not visible"". No treatment received in response to the other events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The outcome of the events medium-severe headache, nausea, sensitive to light, mild confusion, lack of concentration, muscle spasm, neuralgia in left upper and lower extremities, dryness of skin around lips, ""peeling/dryness of skin around lips/it appeared patient have eye shadow but peeling was not visible"", burning and itch of lip region, post vaccination burning, itching redness to eye lids, and ""it appeared patient have eye shadow"" was not recovered. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,UNK,,,Medical History/Concurrent Conditions: Graves' disease (at age 19),,,"['Confusional state', 'Disturbance in attention', 'Dry skin', 'Erythema of eyelid', 'Eyelid irritation', 'Eyelids pruritus', 'Headache', 'Lip pruritus', 'Muscle spasms', 'Nausea', 'Neuralgia', 'Oral discomfort', 'Photophobia', 'Skin discolouration', 'Skin exfoliation']",1,PFIZER\BIONTECH,OT 927609,CA,20.0,F,"palpitations; 3 days straight skin rash with itching on her left leg; muscle soreness on arm of injection site; muscle soreness on arm of injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 20-year-old female patient received the first dose of bnt162b2 (Covid 19 vaccine, brand: Pfizer) via an unspecified route of administration in right arm on 31Dec2020 10:00 at a single dose for COVID-19 immunization in a hospital. Medical history included GERD and Strep throat, both from unknown dates. Concomitant medication included benzylpenicillin (PENICILLIN). The patient did not receive other vaccine in four weeks. The patient experienced palpitations - 3 days straight skin rash with itching on her left leg, muscle soreness on arm of injection site, all on 31Dec2020 11:00. The events were reported as non-serious. The patient did not receive treatment for the events. The patient had not recovered from the events. Information on the lot number/Batch number was requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,PENICILLIN,,Medical History/Concurrent Conditions: GERD; Streptococcal sore throat,,,"['Pain in extremity', 'Palpitations', 'Rash pruritic', 'Vaccination site pain']",1,PFIZER\BIONTECH, 927610,MI,49.0,F,"Some skin rashes as reaction when there is an allergen; Rash/They red bumps and itches; Rash/They red bumps and itches; This is a spontaneous report from a contactable other hcp. A 49-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140), intramuscular (arm left) on 28Dec2020 12:00 at single dose (dose 1) for COVID-19 immunization. Medical history included psoriasis from an unknown date and allergies to medications, food, or other products (unspecified). The patient was taking unspecified concomitant medications including a vaccine within 2 weeks. Patient did not receive other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 with unknown results. On 29Dec2020 04:00, the patient had some skin rashes as a reaction when there is an allergen. After the vaccines, she has been having occasional rashes that pops at different places. They were red bumps and itches. She stated she needed to keep antihistamines CLARITIN/BENADRYL on the clock. Event outcome was not recovered. The patient underwent lab tests and procedures which included COVID test (Nasal swab): negative on 24Nov2020. Event outcome was not recovered. Patient considered the events as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,UNK,,,Medical History/Concurrent Conditions: Allergy NOS (unspecified); Psoriasis,,,"['Dermatitis allergic', 'Rash papular', 'Rash pruritic', 'SARS-CoV-1 test', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 927611,NY,,F,"nausea; vomiting/Severe bout of vomiting this morning; vertigo; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right deltoid on 30Dec2020 at 15:00 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Jan2021 at 05:00, the patient experienced nausea, vomiting/severe bout of vomiting, and vertigo. The patient experienced these same symptoms again on 02Jan2021 at 20:00. The clinical outcomes of nausea, vomiting, and vertigo were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/02/2021,3.0,UNK,,,,,,"['Nausea', 'Vertigo', 'Vomiting']",1,PFIZER\BIONTECH, 927612,CA,55.0,M,"Mild soreness left arm for one day post vaccination; This is a spontaneous report from a contactable physician (patient). A 55-year-old male patient received bnt162b2 (BNT162B2 also reported as Covid-19 vaccine; lot number: EJ1685; expiration date: unknown), via an unspecified route of administration left arm on 19Dec2020 05:00 PM at a single dose for covid-19 vaccination. The patient has no medical history. The patient has no known allergies. The patient was not patient diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medications the patient received within 2 weeks of vaccination. It was reported that the patient received the COVID-19 vaccine in a hospital on 19Dec2020 05:00 PM. On 20Dec2020, the patient had mild soreness left arm for one day post vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient considered the events as non-serious. No treatment received for the adverse event. The outcome of the event was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/20/2020,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Myalgia'],1,PFIZER\BIONTECH, 927613,MI,24.0,M,"Fatigue; Headaches; This is a spontaneous report from a contactable healthcare professional. A 24-year-old male patient received bnt162b2 (BNT162B2 also reported Covid 19 vaccine; lot number: EJ1686; expiration date: unknown), via an unspecified route of administration on 29Dec2020 15:30 at a single dose for covid-19 immunization. Medical history included sulfa antibiotics. The patient's concomitant medications were not reported. The patient previously took amoxicillin but had allergies. The patient was not patient diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medications the patient received within 2 weeks of vaccination. The patient reported the headache started 20 hours post vaccination (30Dec2020 11:30) which did not resolved with acetaminophen but was resolved after night's sleep (12-18 hours later). The patient also had fatigue which was worst on the first full day after shot but was back to normal after 3 days. The outcome of the events was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,UNK,,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,"['Fatigue', 'Headache']",1,PFIZER\BIONTECH, 927614,WI,34.0,M,"was diagnosis with COVID-19 through nasopharyngeal swab today, 02Jan2021; was diagnosis with COVID-19 through nasopharyngeal swab today, 02Jan2021; This is a spontaneous report from a contactable pharmacist (patient himself). A 34-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EJ1685, expiry date not reported), via an unspecified route of administration in his right arm on 23Dec2020 15:30 at single dose, for Covid-19 vaccination. The patient's medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included bupropion. The patient informed that he was diagnosed with Covid-19 through nasopharyngeal swab (COVID-19 Nucleic Acid Amplification test) on 02Jan2021 01:00 and Influenza virus test was unknown results (02Jan2021). It was unknown if there was a treatment used. The outcome of event was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/02/2021,10.0,PVT,,,,,,"['COVID-19', 'Influenza virus test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 927615,TN,64.0,F,"redness at injection site; Mildly tender injection site; slight swelling at injection site; This is a spontaneous report from a contactable nurse. A 64-year-old non-pregnant female patient received bnt162b2 (BNT162B2 also reported as COVID-19 vaccine; lot number: EL 3246; expiration date: unknown), via an unspecified route of administration left arm on 02Jan2021 15:45 at a single dose for covid-19 vaccination. Medical history included HTN (hypertension) and controlled PAT (paroxysmal atrial tachycardia). Concomitant medication included unspecified medication. The patient previously took cephalexin [reported as Cephlexin]. The patient was not patient diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the COVID-19 vaccine in a public health clinic/facility. It was reported that the patient had mildly tender injection site, slight swelling and redness at injection site on 02Jan2021 08:00 PM. The reporter did not consider the event serious. The patient was not tested for COVID-19 since the vaccination. The patient did not received treatment for the adverse event. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PUB,,,Medical History/Concurrent Conditions: Hypertension; Paroxysmal atrial tachycardia,,,"['Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 927616,CA,29.0,F,"Headache and nausea with vomiting; Headache and nausea with vomiting; Headache and nausea with vomiting; This is a spontaneous report from a contactable Other HCP (patient). A 29-year-old female patient received the first dose of BNT162B2 (Lot number and expiry date not reported), intramuscular on 30Dec2020 07:15 at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. On 01Jan2021, the patient experienced headache and nausea with vomiting. No treatment received for all the events. The outcome of the events was recovered on an unspecified date. The following information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,,,,,,"['Headache', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,OT 927617,NC,32.0,F,"Body aches, low grade fever, chills 4 days after vaccine; Body aches, low grade fever, chills 4 days after vaccine; Body aches, low grade fever, chills 4 days after vaccine; This is a spontaneous report from a contactable other HCP (patient). A 32-year-old female patient received the first dose of BNT162B2 (lot number: EJ1685), via an unspecified route of administration on 28Dec2020 09:45 at single dose in the right arm for COVID-19 immunization. Medical history included hypothyroidism from an unknown date. Concomitant medication included levothyroxine and topiramate. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced body aches, low grade fever, chills 4 days after vaccine on 01Jan2021 15:30. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 02Jan2021. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/01/2021,4.0,WRK,;,,Medical History/Concurrent Conditions: Hypothyroidism,,,"['Chills', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 927618,,34.0,F,"herpes zoster on the left and mid back in the L1 distribution; This is a spontaneous report from a contactable physician (patient). A 34-year-old non pregnant female patient received bnt162b2 (lot number: EK9231), via an unspecified route of administration on 22Dec2020 in left arm at single dose for Covid-19 immunization. Medical history was none. There were no other medications the patient received within 2 weeks of vaccination. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On unspecified date, the patient experienced herpes zoster on the left and mid back in the L1 distribution. She was not otherwise immunosuppressed and never had zoster before. The event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered with sequel (reported as Recovered with lasting effects). Therapeutic measures were taken as a result of the event which included Valacyclovir. The event was considered as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Herpes zoster'],UNK,PFIZER\BIONTECH, 927619,GA,22.0,F,"On the third morning after the shot, at 3 a.m., was awakened to a racing heart. The racing heart was on and off until getting out of the bed at 7 a.m.; Oe spot was visible on the upper left arm; Rash on lower right leg above the ankle; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 31Dec2020 at 13:30 at a single dose for COVID-19 immunization at the Public Health Clinic facility (as reported). The patient's medical history and concomitant medications were not reported. The patient has no known allergies. The patient is not pregnant. The patient was has not received any other vaccine in four weeks and has not have other medications in two weeks. On 31Dec2020 at 17:30, patient reported of rash on lower right leg above the ankle appeared the evening of the shot. Then one spot was visible on the upper left arm the day after the shot (01Jan2021). On the third morning after the shot (03Jan2021), at 3 A.M., patient was awakened to a racing heart. The patient reported that the racing heart was on and off until getting out of the bed at 7 A.M. The patient did not receive treatment in response to the events. The patient assessed the events as non-serious. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PUB,,,,,,"['Macule', 'Palpitations', 'Rash']",1,PFIZER\BIONTECH, 927620,IN,49.0,F,"fever of 2-3 degrees; slept most of the day; didn't feel well at all; headache; achey; tired/exhausted; sore arm; woke her up briefly; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the right arm on 31Dec2020 10:00 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included spending 4-6 hrs/day face-to-face with Covid patients for months since early Apr2020. The patient has no known allergies. The patient has no covid prior vaccination, and she was not tested for covid post vaccination. The patient's concomitant medication included multivitamin. The patient did not receive other vaccine in last four weeks. The patient was vaccinated on 31Dec2020 at 10am for her 1st Pfizer vaccine. No symptoms for 6-8 hrs. By bedtime at 06:00 PM, she experienced headache, achey, tired, and sleeping on her sore arm woke her up briefly. Next day on 01Jan2021, more achey, exhausted, fever of 2-3 degrees, slept most of the day and didn't feel well at all. She could tell that her body was fighting something, but she is much better 48 hours out. The patient did not receive any treatment for the reported adverse events. She stated she had no regrets. She stated that she loves Pfizer, because it has given hope. She just wasn't expecting any side effects after the 1st vaccine, only for the 2nd. Anecdotally, it seemed her hospital coworkers who have had Covid react more to the 1st vaccine, possibly for them, 1st vaccine is like the 2nd. She doesn't know if she has had Covid, but as an Acute Care PT on Covid units, she spends 4-6 hrs/day face-to-face with Covid patients for months since early Apr2020. She stated that possible her immune system already recognizes Covid. She is curious. No complaints, only curious. Again, she said thank you. She stated that she has seen too many good people die this year, thus, she didn't hesitate on the vaccine. The outcome of the events was recovered in Jan2021. The report was considered non-serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Occupational exposure to COVID-19 (face-to-face with Covid patients for months since early Apr2020),,,"['Fatigue', 'Headache', 'Malaise', 'Middle insomnia', 'Pain', 'Pain in extremity', 'Pyrexia', 'Somnolence']",1,PFIZER\BIONTECH, 927621,NY,50.0,F,"I experienced rigors; Extreme fatigue; Fever spiked to 102.4 in the evening, the day after vaccine.; Very mild headache and very mild queasiness; Very mild headache and very mild queasiness; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at the left arm on 31Dec2020 at 11:45 at a single dose for COVID-19 immunization in the hospital. The patient has not have any vaccines in four weeks and did not take any medications in two weeks. The patient is not pregnant. Medical history included asthma, grade 1 casein allergy, environmental allergies, mild hypertension and high cholesterol. Concomitant medications included montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), nifedipine (PROCARDIA) and atorvastatin (LIPITOR). On 31Dec2020 at 09:00 PM, approximately 9 hours after receiving the vaccine, the patient experienced rigors which lasted much of the night. Extreme fatigue. Patient reported that ibuprofen was taken with no relief. Tylenol taken the next day. Fever spiked to 102.4 in the evening, the day after vaccine. The patient did not record her temperature overnight during rigors. The patient also reported of a very mild headache and very mild queasiness. The patient also took Benadryl, self-administered per MD. The symptoms were gone by the morning of the second day. The patient assessed the events as non-serious. The patient recovered from the events on an unspecified date in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination. Information about Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,SINGULAIR; ALLEGRA; PROCARDIA [NIFEDIPINE]; LIPITOR [ATORVASTATIN],,Medical History/Concurrent Conditions: Asthma; Environmental allergy; High cholesterol; Hypertension; Milk protein allergy,,,"['Body temperature', 'Chills', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH, 927622,TX,55.0,M,"Joint pain; Pain at injection site; Fever of 100.4; This is a spontaneous report from a contactable healthcare professional. A 55-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 17Dec2020 14:00 in right arm at single dose for COVID-19 immunization. Medical history included allergies to Ovaltine from an unknown date and unknown if ongoing. Concomitant medication included atorvastatin calcium (LIPITOR). On 25Dec2020, the patient experienced pain at injection site x 2 days, fever of 100.4 and joint pain at day 7. The facility where the most recent COVID-19 vaccine was administered was in a military base. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event pain at injection site was recovered in Dec2020 and the outcome of the remaining events was recovered on unspecified date. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/25/2020,8.0,MIL,LIPITOR [ATORVASTATIN CALCIUM],,Medical History/Concurrent Conditions: Food allergy,,,"['Arthralgia', 'Body temperature', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 927623,,64.0,M,"fever; chills; nausea; headache; fatigue; had a local reaction of a ""patch of inflammation, redness, burning sensation- similar to a 2nd degree burn.""; had a local reaction of a ""patch of inflammation, redness, burning sensation- similar to a 2nd degree burn.""; had a local reaction of a ""patch of inflammation, redness, burning sensation- similar to a 2nd degree burn.""; This is a spontaneous report from a contactable physician (patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on 19Dec2020 at a single dose for Covid-19 immunization. Medical history included pneumonia from 03Aug2020 to 08Aug2020. Concomitant medications were not reported. Patient had the first COVID-19 vaccine dose on 19Dec2020. Patient said he had a ""pretty strong reaction"" of fever, chills, nausea, headache, fatigue in Dec2020. Felt ill until day 2, started feeling better on day 3. Patient also had a local reaction of a ""patch of inflammation, redness, burning sensation- similar to a 2nd degree burn"" in Dec2020. Patient also mentioned he had his blood work last 30Dec2020 and confirmed he has IgG antibodies. Patient then asked ""I want to get the second dose, is it okay to get the vaccine?"" The outcome of the events 'fever, chills, nausea, headache, fatigue' was recovering while unknown for the other events. Information about Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: Pneumonia,,,"['Blood test', 'Chills', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia', 'Vaccination site erythema', 'Vaccination site inflammation', 'Vaccination site pain']",1,PFIZER\BIONTECH, 927624,MD,53.0,F,"swollen/sore lymph node in left neck/clavicle area after about several days; swollen/sore lymph node in left neck/clavicle area after about several days; This is a spontaneous report from a contactable nurse (patient herself). A 53-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Solution for injection; lot number: EL0140; expiration date: not known), via an unspecified route of administration on 24Dec2020 08:00 (left arm) at single dose for covid-19 immunisation. Medical history included depression, hypertension (HTN), and high cholesterol. The patient had allergies with sulfa and beta blockers. The patient's concomitant medications were not reported. The patient previously took pravastatin sodium (PRAVACHOL) and experienced allergies. The patient was vaccinated at a hospital and was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2 vaccine and received other medications within 2 weeks of vaccination but were unspecified. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced swollen/sore lymph node in left neck/clavicle area after about several days on an unspecified date (reported as ""01Dec2020"", pending clarification). The reported events were non-serious. The patient did not receive treatment for these reported events. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,,,PVT,,,Medical History/Concurrent Conditions: Depression; Drug allergy; High cholesterol; Hypertension; Sulfonamide allergy,,,"['Blood cholesterol', 'Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH, 927625,PA,31.0,F,"On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity; On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity; On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity; Developed diffuse, pinpoint, non-pruritic, flat rash to trunk.; redness, and itching at injection site; redness, and itching at injection site; Developed mild hives at injection site/large, urticarial hives at injection site; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231), intramuscular from 28Dec2020 08:00 at single dose in the right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took cephalosporin and experienced allergies. The patient developed mild hives, redness, and itching at injection site on days 2 and 3. Symptoms resolved entirely on days 4 and 5. On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity. On 30Dec2020, she developed diffuse, pinpoint, non-pruritic, flat rash to trunk. Rash resolved with Benadryl. Extremity pain and burning persists despite Benadryl. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any other medications within 2 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did receive treatment for the events which included Benadryl and Pepcid. The events resulted in emergency room/department or urgent care. The outcome of the events ""Developed mild hives at injection site/large, urticarial hives at injection site"", ""On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity"" was unknown; for events ""Paraesthesia"" and ""pain in extremity"" was not recovered; and for the other events was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,,,,,,"['Burning sensation', 'Pain in extremity', 'Paraesthesia', 'Rash', 'Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site urticaria']",1,PFIZER\BIONTECH,OT 927626,,,F,"small rash that has been getting larger; This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age (reported as age: 30, unit: unknown) received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 19Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Laboratory employee received her first dose of vaccine on 19Dec2020. On 01Jan2021, she developed a small rash that has been getting larger that she has been treating with Benadryl. She is calling to see if she can receive the second dose. The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,01/01/2021,13.0,UNK,,,,,,['Rash'],1,PFIZER\BIONTECH, 927627,,,F,"mild hives on the chest a few hours after receiving the vaccine; her asthma kept flaring up with shortness of breath; her asthma kept flaring up with shortness of breath; breastfeeding; breastfeeding; This is a spontaneous report from a contactable consumer (patient). This consumer reported for both herself and baby. This is a mother report. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is a breastfeeding mother. The patient experienced mild hives on the chest a few hours after receiving the vaccine and her asthma kept flaring up with shortness of breath. She took Benadryl and everything went away. Outcome of the events was recovered. The patient asked if she had side effects to the vaccine is it ok for her to get the second dose. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003624 mother/baby",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Asthma', 'Dyspnoea', 'Off label use', 'Product use issue', 'Urticaria']",UNK,PFIZER\BIONTECH, 927628,VA,42.0,F,"whole body ached/shingles like pain in my butt/legs/groin to where my skin hurt to touch it/pain was excruciating/the vaccine amplified the pain; sore arm; progressed to Flu like symptoms; Arthritis in her knee/vaccine amplified the pain; This is a spontaneous report from a contactable healthcare professional. A 42-year-old female patient received bnt162b2 (BNT162B2; also reported as COVID-19 vaccine; lot number: EH 9899; expiration date: unknown), intramuscular left arm on 30Dec2020 20:30 at a single dose for covid-19 vaccination. Medical history included arthritis in my knee, labrum hip tear, HSV2 (herpes simplex virus type 2), haven't had an OB [pending clarification] in over 2 years and herpes. Concomitant medication included omeprazole (PRILOSEC), ondansetron (ZOFRAN MELT), alprazolam (XANAX; reported as Xanax ER), lamotrigine (LAMICTAL), famotidine (PEPCID AC) , colecalciferol (VITAMINS D3; reported as vitamin D), ascorbic acid (VIT-C) and zinc. The reporter stated that after the vaccine (31Dec2020 12:00), the patient had a sore arm and it progressed to Flu like symptoms and pain in her joints. Her whole body ached. The patient mentioned that she has arthritis in her knee and a labrum hip tear, and the vaccine amplified the pain. She also has HSV2 and she haven't had an OB in over 2 years, and she had a bad OB and shingles like pain in her butt/legs/groin to where her skin hurt to touch it. The pain was excruciating. The patient did not received treatment for the adverse event. The patient considered the event as non-serious. She received the COVID-19 vaccine in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,PRILOSEC [OMEPRAZOLE]; ZOFRAN MELT; XANAX; LAMICTAL; PEPCID AC; VITAMINS D3; VIT-C;,,Medical History/Concurrent Conditions: Cartilage injury; Herpes simplex type II; Knee arthritis; Obliterative bronchiolitis (havent had an OB in over 2 years); Shingles,,,"['Arthralgia', 'Influenza like illness', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,OT 927629,MD,24.0,F,"also had a very hoarse voice; throat starting feeling a little tight; This is a spontaneous report from a contactable Other HCP (patient). A 24-year-old female patient received first dose of BNT162B2 (Lot number: EK9231), intramuscular on 31Dec2020 15:45 at single dose in the left arm for COVID-19 immunization. Medical history included chronic sinusitis from an unknown date and seasonal allergies from an unknown date. Concomitant medication included azithromycin. The patient previously took penicillin and experienced allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that within 10 minutes of receiving the vaccine on 31Dec2020, the patient's throat started feeling a little tight. However, she did not have trouble breathing. The feeling continued for the next 3 hours. She also had a very hoarse voice. The ER suggested that she will be seen. They did an exam and gave her Benadryl which completely resolved her symptoms. The events resulted in emergency room/department or urgent care.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,"Medical History/Concurrent Conditions: Chronic sinusitis; Seasonal allergy (Allergies to medications, food, or other products: Penicillin, seasonal allergies)",,,"['Dysphonia', 'Investigation', 'Throat tightness']",1,PFIZER\BIONTECH,OT 927630,,,F,"she received the Pfizer vaccine on 29Dec2020. She tested positive for coronavirus on 01Jan2021. Is the efficacy of the vaccine after the second dose?; tested positive for coronavirus; This is a spontaneous report from a contactable nurse reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. VA nurse calling stating that she received the Pfizer vaccine on 29Dec2020. She tested positive for coronavirus on 01Jan2021. She wanted to know how to proceed with getting her second vaccine, and if the efficacy of the vaccine is after the second dose. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and Coronavirus test positive cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/01/2021,3.0,UNK,,,,,,['Coronavirus test positive'],1,PFIZER\BIONTECH, 927631,MI,57.0,F,"had intermittent abdominal pain that hit at 72 hours (late last night, early this morning); began with nausea and it comes in waves/continues in waves along with the nausea, it comes and goes from moderate severe to low grade; headache; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID 19 vaccine on Wednesday close to noon and reported that, ""I didn't notice any symptoms until yesterday morning (02Jan2021), I began with nausea and it comes in waves. I did have headache that began Friday evening (01Jan2021) and continues in waves along with the nausea, it comes and goes from moderate severe to low grade. I then had intermittent abdominal pain that hit at 72 hours (late last night, early this morning, 03Jan2021). No diarrhea associated with it. I can't find abdominal pain on the paperwork that was provided to me. is this also one of the expected or reported side effects?"" The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/01/2021,2.0,UNK,,,,,,"['Abdominal pain', 'Headache', 'Nausea']",1,PFIZER\BIONTECH, 927632,CA,62.0,M,"Constant tinnitus; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the first dose of bnt162b2 (Covid 19 vaccine, brand: Pfizer) lot no: EJ1685, via an unspecified route of administration in right arm on 29Dec2020 11:00 at a single dose for COVID-19 immunization. The patient had no other medical history. No known allergies. Concomitant medication included fish oil, allium sativum (GARLIC), ascorbic acid (VITAMINS C), vitamin D, vitamin K, and multivitamin. The patient did not receive other vaccines within 4 weeks prior to the covid vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced constant tinnitus on 30Dec2020 12:00. The event was reported as non-serious. The patient did not receive treatment for the event. The patient had not recovered from the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PUB,; GARLIC [ALLIUM SATIVUM]; VITAMINS C; VITAMIN D [VITAMIN D NOS]; VITAMIN K [VITAMIN K NOS],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Tinnitus'],1,PFIZER\BIONTECH, 927633,,,F,"received vaccine on 17Dec2020, then tested positive for coronavirus on 25Dec2020; received vaccine on 17Dec2020, then tested positive for coronavirus on 25Dec2020; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received vaccine on 17Dec2020, then tested positive for coronavirus on 25Dec2020. The patient was calling to inquire if she can get second vaccine. Outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/25/2020,8.0,UNK,,,,,,['Coronavirus test positive'],1,PFIZER\BIONTECH, 927634,,,F,"headache; sore throat; pulse stayed up from 120 - 140 bpm; didn't sleep other than that first night except for about 2 hours at a time.; felt like I was about to get a cold, but then it went away; immediately felt sleepy; couldn't function and wasn't feeling well; tired /fatigue; This is a spontaneous report from a non-contactable Nurse. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 22Dec2020 at single dose for COVID-19 immunization. Relevant medical history included high blood pressure. Concomitant medications included vitamin B. Patient informed that since an unspecified date in Dec2020 after receiving vaccine she immediately felt sleepy, she asked other's that I work with if they felt sleepy. (None reported feeling sleepy). Patient went back to work and took Vitamin B and Coca Cola. She went to sleep 8 pm that evening and stayed asleep all night, and woke up at 6:-6:30 am. On 23Dec2020 she called out of work because so tired. I went to work the next day (Thursday, 24Dec2020) and couldn't function, she wasn't feeling well but stayed for her entire shift. She woke up the next day with a sore throat. From Wednesday (23Dec2020) her pulse stayed up from 120-140 bpm. The pulse went back to normal on the following Wednesday, it took a week for it to get back to normal. She didn't sleep other than that first night except for about 2 hours at a time. Patient felt like she was about to get a cold, but then it went away. She took her soup and didn't go to work for a week. Patient returned to work on Monday the 28Dec2020. All of her symptoms (fatigue, headache, sore throat) subsided on Wednesday 30Dec2020. Patient also reported that a Co-worker told her that the day after the vaccine said she had chills, not feeling well. Her friend said she will call to report and did not want to provide any demographic information on her behalf. Another Nurse - felt congested and worried. (Yesterday), also no demographic information provided. The Provider (he participated in the clinical trial and had the placebo) received the vaccine the same day as she and he will be calling also. He had body aches and headache. No follow up attempts are possible; Information on lot/batch cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/01/2020,,UNK,VITAMIN B,,Medical History/Concurrent Conditions: Blood pressure abnormal,,,"['Fatigue', 'Headache', 'Heart rate', 'Malaise', 'Nasopharyngitis', 'Oropharyngeal pain', 'Pulse abnormal', 'Sleep disorder', 'Somnolence']",UNK,PFIZER\BIONTECH, 927635,,,F,"chills; headache; body ache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (age: 41; unit: unknown) received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Solution for injection; lot number and expiration date: not known), on 24Dec2020 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got vaccinated on 24Dec2020 and after 1 week, which was exactly last Friday afternoon (01Jan2021), she started to experienced chills, headache and body ache. The patient wanted to know if this is normal and how long before it goes away. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,01/01/2021,8.0,UNK,,,,,,"['Chills', 'Headache', 'Pain']",UNK,PFIZER\BIONTECH, 927636,,32.0,M,"Mild to moderate pain at injection site.; Severe tension headache that started approximately 24 hours after injection and lasted approximately 18 hours; This is a spontaneous report from a contactable physician (patient). A 32-year-old male patient received the first dose of bnt162b2 (COVID 19 vaccine, brand: Pfizer) lot no: EH9899, via an unspecified route of administration in left arm on 27Dec2020 12:30 at a single for COVID-19 immunization in workplace clinic. There were no relevant medical history and concomitant medications. The patient had no COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. No known allergies. The patient did not receive other vaccines in four weeks or other medications in two weeks. On 28Dec2020 at 12:00 pm, the patient experienced mild to moderate pain at injection site. Severe tension headache that started approximately 24 hours after injection and lasted approximately 18 hours. The events were alleviated by single acetaminophen (TYLENOL) and sleep. The events were reported as non-serious. The patient recovered from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/28/2020,1.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Tension headache', 'Vaccination site pain']",1,PFIZER\BIONTECH, 927637,TX,40.0,F,"Dizziness; Diarrhea; Sore Arm; Headache; Fatigued; Chills; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at the left arm on 31Dec2020 13:00 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient experienced dizziness, diarrhea, sore arm, headache, fatigued, and chills on 01Jan2021. The patient did not received any treatment for the evets. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19 via a blood test in Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks. The patient recovered from the events on an unknown date in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,,,,,,"['Chills', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Pain in extremity', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 927638,MA,51.0,F,"feeling very shaky and dizzy when I stand up.; feeling very shaky and dizzy when I stand up.; This is a spontaneous report from a contactable other health professional (patient). A 51-year-old female patient received the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19, lot number and expiry date not reported), intramuscular on 03Jan2021 13:15 at a single dose on right arm for COVID-19 immunisation. Medical history included none. The patient had no known allergies to medications, food, or other products. There were no concomitant medications. The patient reported, ""I'm feeling very shaky and dizzy when I stand up on 03Jan2021 14:30. No treatment was given for the events. The outcome of the events was unknown. The events were considered as non-serious. Facility where the most recent COVID-19 vaccine was administered was in Nursing Home/Senior Living Facility. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications received within 2 weeks of vaccination. Prior to vaccination and since the vaccination, the patient was not diagnosed with COVID-19. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dizziness postural', 'Nervousness']",1,PFIZER\BIONTECH,OT 927639,CO,44.0,M,"Injection site soreness only first 24hrs.; fatigue; chills; fever of 99.8 F; body aches; headache; vomiting; Diarrhea; This is a spontaneous report from a contactable other health professional (patient). A 44-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 22Dec2020 14:00 at single dose at right arm for COVID-19 immunization. Medical history included Asthma, no Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included budesonide, formoterol fumarate (SYMBICORT), omeprazole. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that injection site soreness only first 24hrs. At 30 hrs, fatigue, chills, fever of 99.8 Fahrenheit (F), body aches, headache, vomiting and diarrhea. These lasted for 24hrs. Diarrhea persisted for 48 hrs. To the best of his knowledge he had not ever been exposed to Covid. The events onset date reported as 23Dec2020 23:00 (pending clarification). Treatment received for the adverse event reported as ""Called nurse line"". The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/23/2020,1.0,PVT,SYMBICORT;,,Medical History/Concurrent Conditions: Asthma,,,"['Body temperature', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Pain', 'Pyrexia', 'Vaccination site pain', 'Vomiting']",1,PFIZER\BIONTECH, 927640,,,F,"became positive for covid 19; became positive for covid 19; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) via an unspecified route of administration on 22Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient she received covid vaccine on 22Dec2020 and on 30Dec2020 became positive for covid 19. The patient wanted to know when she can schedule her 2nd dose. Outcome of the event was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/30/2020,8.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 927641,,44.0,F,"slight cough; diarrhea; shortness of breath; no sense of smell; positive for covid 19 virus; positive for covid 19 virus; feel tired; sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 20Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was Diagnosed with covid 19 virus on the 31Dec2020, she was set to have the second vaccine on the 10Jan2021. She wanted to know if she can get the second dose and if so, when. Also asked if she should get tested before taking the 2nd dose of the covid 19 vaccine. Her Adverse effects are sore arm on vaccination day (20Dec2020), and she began to feel tired on 27Dec2020 and thought that was normal. She went to a Christmas eve party 24Dec2020 and no one was masked, friend had several people from work tested positive. was tested and was positive for covid 19 virus on 31Dec2020. She also was experiencing slight cough, diarrhea (which is normal for her), shortness of breath is improving and she had no sense of smell but she was able to taste. The outcome of event shortness of breath is recovering. The outcome of other events was unknown. No follow-up attempts are possible. information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/20/2020,0.0,UNK,,,,,,"['Anosmia', 'COVID-19', 'Cough', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Pain in extremity', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 927642,PA,30.0,F,"Low grade fever; Tingling face and tongue; Muscle aches; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, intramuscular on left arm on 02Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included fibromyalgia. The patient was not pregnant. Patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced low grade fever, tingling face and tongue, muscle aches, and fatigue, all on 03Jan2021 06:00. The events were reported as non-serious. Patient was not diagnosed with COVID-19 and has not been tested for COVID-19 prior to vaccination. Outcome of the events was recovering. Information on the Lot/Batch Number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Fibromyalgia,,,"['Fatigue', 'Myalgia', 'Paraesthesia', 'Pyrexia']",1,PFIZER\BIONTECH,OT 927643,MA,42.0,F,"Fever up to 100.8 (unknown unit); chills; shaking; general muscle aches; generalized sensitive skin; mild headache lasting 1 day; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EK5730, intramuscular on Right arm from 22Dec2020 09:45 to 22Dec2020 09:45 as single dose for COVID-19 immunization. Medical history included hypertension, and glaucoma. Concomitant medication included losartan (LOSARTAN), hctz (HCTZ), fluticasone propionate (FLONASE), and latanoprost (XALATAN). On 24Dec2020 08:30 am, the patient experienced fever up to 100.8 (unknown unit), chills, shaking, general muscle aches, generalized sensitive skin, mild headache lasting 1 day. The patient was not tested for Covid post vaccination. The patient is not pregnant. The outcome of the events was recovered on 25Dec2020. No treatment was received for the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,PVT,; HCTZ; FLONASE [FLUTICASONE PROPIONATE]; XALATAN,,Medical History/Concurrent Conditions: Glaucoma; Hypertension,,,"['Chills', 'Headache', 'Myalgia', 'Pyrexia', 'Sensitive skin', 'Tremor']",1,PFIZER\BIONTECH,OT 927644,,,F,"she has a suspected exposure to a COVID19 patient/develops symptoms is unable to get the 2nd dose in time; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient herself). A female patient of an unspecified ag received bnt162b2 (BNT162B2 also reported as PFIZER COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on unspecified date at single dose, for Covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient was asking if she can get her second shot if she had a suspected exposure to a COVID19 patient and if she developed symptoms and was unable to get the 2nd dose in time, when will the new schedule be. The outcome of event was unknown. Lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Suspected COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Suspected COVID-19'],UNK,PFIZER\BIONTECH, 927645,,,M,"flu-like symptoms; feel sick; This is a spontaneous report from a contactable nurse (patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was experiencing flu-like symptoms on an unspecified date. Patient feel sick for almost a week now as of this report. Outcome of the events was unknown. Information about Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,,,UNK,,,,,,"['Influenza like illness', 'Malaise']",1,PFIZER\BIONTECH, 927646,,,F,"headache (with progression to migraine on 30Dec2020); headache (with progression to migraine on 30Dec2020); This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration dates were unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunisation. Patient was told she was exposed to a Covid positive patient on the day prior to receiving her vaccine (28Dec2020). The patient's concomitant medications were not reported. Patient experienced a headache with progression to migraine on 30Dec2020, off and on since 30Dec2020. Outcome of the events was unknown. She was asking if she gets tested for Covid, will the test results be affected by the vaccine. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,UNK,,,Medical History/Concurrent Conditions: Exposure to COVID-19,,,"['Headache', 'Migraine']",UNK,PFIZER\BIONTECH, 927647,CA,51.0,F,"Muscle pain; Shortness of breath; Tiredness; Nausea; Sweating; Mild soreness at infection site; Mild soreness at infection site; This is a Spontaneous report from a contactable Other HCP (patient). A 51-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number=EH9899), on 30Dec2020 12:00 PM, Intramuscularly at single dose (first dose), (vaccine location=Left arm) for COVID-19 immunization. Medical history included Covid; Hypertension; Diabetes Type 2. Concomitant medications were not reported. Patient was no Known allergies. Patient experienced Muscle pain, shortness of breath, tiredness, nausea, sweating, mild soreness at infection site on 02Jan2021 09:00 AM. Patient did not receive any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient did not have been tested for COVID-19. The outcome of the events was not recovered. This case was assessed non-serious by reporter. And the events did not result in Death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,OTH,,,Medical History/Concurrent Conditions: COVID-19; Hypertension; Type 2 diabetes mellitus,,,"['Dyspnoea', 'Fatigue', 'Hyperhidrosis', 'Myalgia', 'Nausea', 'Vaccination site infection', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 927648,TX,62.0,F,"Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Weakness/generalized weakness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162b2 (Pfizer, Lot number: 5730), via an unspecified route of administration at right arm at 22Dec2020 21:00 at single dose for covid-19 immunization. Medical history included Mayonaise allergies. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. At 31Dec2020 06:00, the patient experienced Weakness, nausea, occasional dry cough, generalized weakness, neck and lower back soreness, and sore throat which has now dissipated. Tested Positive for COVID-19 on 02Jan2021 (also reported as 01Jan2021, pending clarification). The covid test type post vaccination was Nasal Swab, Covid test name post vaccination was COVID-19 PCR ROCHE c6800(NTX), RNA SARS CoV2 TGT1, PAN SARS RNA TGT2. No treatment received for events. The events result in Emergency room/department or urgent care. The patient was not pregnant. The outcome of the events were nor recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/31/2020,9.0,PVT,,,Medical History/Concurrent Conditions: Food allergy,,,"['Asthenia', 'Back pain', 'Cough', 'Nausea', 'Neck pain', 'Oropharyngeal pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 927649,,,F,"shoulder pain; shoulder pain, from the injection site; shoulder pain, from the injection site, began to spread through the pectoral muscle; shoulder pain, from the injection site, began to spread through the pectoral muscle and through the chest/soreness of my left arm and chest; soreness of my left arm; swollen lymph node in my collar bone, like a goose egg; pain from my left collar bone to my sternum; swollen lymph node in my collar bone, like a goose egg, and is tender to touch; discomfort; This is a spontaneous report from a non-contactable consumer via Medical information team. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. Medical history included Crohn's disease from an unknown date and unknown if ongoing. The patient stated, ""started experiencing effects that night; (L) shoulder pain, from the injection site, began to spread through the pectoral muscle and through the chest, and my left side. No other issues, no other reactions, just soreness of my left arm and chest and a swollen lymph node in my collar bone, like a goose egg, and is tender to touch. I chatted with my gastroenterologist, I have Crohn's disease and am on a biologic medication. My doctor stated that this could just be an immune response. I am having pain from my left collar bone to my sternum that is always persistent all the time and flares at times, when doing some movement. The area is tender to touch but I feel discomfort all the time through that left side. I also feel this when I take a deep breath. I even experience this with a flu shot, but doesn't last this long. I will be going to see my doctor so that he can evaluate me."" The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,,,UNK,,,Medical History/Concurrent Conditions: Crohn's disease,,,"['Arthralgia', 'Bone pain', 'Chest pain', 'Discomfort', 'Lymph node pain', 'Lymphadenopathy', 'Myalgia', 'Pain in extremity', 'Vaccination site pain']",1,PFIZER\BIONTECH, 927650,SC,35.0,F,"Heart palpitations; elevated heart rate and bp; elevated heart rate and bp; initially burning/tingly injection site; initially burning/tingly injection site; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then throat got hoarse; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the right arm, on 03Jan2021 at 14:30 (at the age of 35-years-old) at a single dose for COVID-19 immunization. Medical history included asthma (no medication used), irritable bowel syndrome (IBS) and reflux, headaches, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included pantoprazole sodium sesquihydrate (PROTONIX), venlafaxine (MANUFACTURER UNKNOWN) taken for headaches, curcuma longa (TURMERIC; MANUFACTURER UNKNOWN), and probiotics (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse on 03Jan2021 at 14:30. The events were reported as non-serious. The events required a visit to the emergency room. The patient underwent lab tests and procedures which included: BP: elevated and heart rate: elevated, both on 03Jan2021. Therapeutic measures were taken as a result of the events, which included treatment with diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), and famotidine (PEPCID). The clinical outcome of heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,PVT,PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; ; TURMERIC [CURCUMA LONGA];,,Medical History/Concurrent Conditions: Acid reflux (esophageal); Asthma (no medication used); COVID-19 (Prior to vaccination); Headache; Irritable bowel syndrome,,,"['Blood pressure increased', 'Blood pressure measurement', 'Dysphonia', 'Heart rate', 'Heart rate increased', 'Hypoaesthesia oral', 'Palpitations', 'Paraesthesia oral', 'Pharyngeal hypoaesthesia', 'Pharyngeal paraesthesia', 'Vaccination site pain', 'Vaccination site paraesthesia']",1,PFIZER\BIONTECH, 927651,,,F,"big bump/bigger than a dollar coin; soreness over 24 hours; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 48, unknown unit) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration dates were unknown), via an unspecified route of administration on 25Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had soreness over 24 hours on Dec2020. She was wondering if the person who administered it, administered it subcutaneous instead of intramuscularly. Since 25Dec2020 until 03Jan2021, there was a big bump. There was no pain when patient touched it but she felt like it's getting bigger. It wasn't as big. It's bigger than a dollar coin. It was like a raisin. Outcome of the event of big bump was not recovered while for the other event was unknown. Patient was not sure what size needle was used and went back to ask the nurse. When she drew the needle out, there was medication that. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/25/2020,12/01/2020,,UNK,,,,,,"['Pain', 'Vaccination site mass']",UNK,PFIZER\BIONTECH, 927652,,,F,"felt pain on injection site; headache; very achy; cold; This is a spontaneous report from a contactable healthcare professional reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on 24Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took thimerosal and experienced drug allergy. Patient stated that she got the Covid vaccine last 24Dec2020 and felt fantastic for 12 hours and after that she felt pain on injection site, headache, very achy and cold for 2 days in Dec2020 and then it went away. Then last Friday, she experienced the same signs and symptoms and had herself swabbed yesterday and got a negative result. She wanted to know if this is a delayed reaction to the vaccine or if she could be having Covid since she is an HCP is usually exposed to patients. Patient also mentioned that she is allergic to Thimerosal. She mentioned that she is allergic to Thimerosal and wants to know if the Covid vaccine contains any derivatives which may be similar to it. Escalating to inquiry to Second line. Offered to provide list of ingredients which she could check with local pharmacist if it does contain Thimerosal derivatives but insisted that there may be scientists or pharmacists from Pfizer who can check on this information. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/01/2020,,UNK,,,,,,"['Headache', 'Nasopharyngitis', 'Pain', 'SARS-CoV-2 test', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 927653,ID,,F,"nasal congestion; sinus pressure; nausea; extreme fatigue; tingling in hands and feet; Patient reported not able to get out of bed and sleeping most of the day; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This female consumer (in her late 30's) reported for herself that she received BNT162B2 single dose in Dec2020 for COVID-19 immunisation. Medical history included autoimmune disease (not disclosed). Concomitant drugs were not provided. The patient received vaccine on Monday and by Thursday began experiencing nasal congestion, sinus pressure, nausea, extreme fatigue, tingling in hands and feet. Patient reported not able to get out of bed and sleeping most of the day in Dec2020. At report, these symptoms had not subsided. The outcome of the events was not resolved. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/01/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Autoimmune disorder,,,"['Fatigue', 'Nasal congestion', 'Nausea', 'Paraesthesia', 'Paranasal sinus discomfort', 'Somnolence']",UNK,PFIZER\BIONTECH, 927654,CT,,M,"Arm soreness; This is a spontaneous report from a contactable consumer who reported for a patient. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EH9899) via an unspecified route of administration on 22Dec2020 at 06:45 (at an unspecified age) as a single dose in the left arm for COVID-19 immunization. Medical history included allergies to sulfa and nuts, from unspecified dates and unspecified if ongoing. Other medical history was reported as ""none"". Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was reported that it was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccination. On 22Dec2020 the patient experienced ""arm soreness"". It was reported that treatment was not received for the adverse event. The clinical outcome of the event ""arm soreness"" was recovered/resolved on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Allergy to nuts; Sulfonamide allergy (known allergies:Nuts and sulfa drugs),,,['Pain in extremity'],1,PFIZER\BIONTECH, 927655,TN,41.0,F,"Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General aches; fatigue; This is a spontaneous report from a contactable healthcare profess. A 41-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899), intramuscular on 29Dec2020 14:45 at a single dose for Covid-19 immunization. Medical history included colitis ulcerative. Concomitant medications included infliximab (REMICADE), calcium D, sertraline hydrochloride (ZOLOFT), and probiotics. The patient previously took ampicillin sodium (OMNIPEN) and BACTRIM DS and experienced allergies. On 30Dec2020, at 04:45 PM, the patient experienced abdominal cramping and diarrhea on pm overnight, injection site soreness/arm pain, general aches and fatigue. The patient did not receive any treatment for the events. The patient has no Covid prior to vaccination and did not take Covid test post vaccination. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,REMICADE; CALCIUM D [CALCIUM;COLECALCIFEROL]; ZOLOFT;,,Medical History/Concurrent Conditions: Ulcerative colitis,,,"['Abdominal pain', 'Diarrhoea', 'Fatigue', 'Pain', 'Pain in extremity', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 927656,PA,65.0,F,"my hands swelled up/My hands, my feet swollen; My hands, my feet swollen, red and itchy/my hands swelled up, they were red and they were itchy; My hands, my feet swollen, red and itchy/my hands swelled up, they were red and they were itchy; Lymphadenopathy under both arms, red, swollen; the shoulder was swollen and the clavicle area was also swollen; sore arm; It was red like a bubbly rash like a size of pea; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 17Dec2020 17:00 at single dose for COVID-19 immunisation. Medical history included hypertension, hyperlipidaemia. Concomitant medications included lisinopril, amlodipine besilate (NORVASC), ezetimibe (ZETIA), rosuvastatin, fexofenadine, ergocalciferol (VITAMIN D), vitamin a [retinol], vitamin c [ascorbic acid], tocopherol (VITAMIN E), thiamine (VITAMIN B1) , vitamin b2 [riboflavin], niacin, vitamin b6, folic acid, cyanocobalamin (VITAMIN B12) , biotin, pantothenic acid. Registered Nurse stated, ""I received the first dose of Pfizer vaccination on Thursday, 17Dec2020 at 5 PM. I began to have an adverse reaction on Friday, 18Dec2020 at 11 PM and then until the Saturday, 19Dec2020 until after dinner I had (Incomplete sentence). You want me to break it down like what the time and what the affect was? Okay 11 PM on Friday 18th my hands swelled up, they were red and they were itchy. I couldn't get the itching to stop. Hand cream or cold water they finally subsided with cold water and I was able to get sleep. Then I woke up Saturday, 19Dec2020 at 6 AM then was my hands, my feet swollen, red and itchy. Itching was just like, I did not know what to do about it. Used cold water and that rested for about 4 hours. After that stopped I had a rash on my arms, my leg and my abdomen and it just came out of nowhere. It was red like a bubbly rash like a size of pea. You think I looked at I thought what I was going to do. I went I got a cool shower another 4 hours that subsided not completely but enough where it wasn't scary anymore, it was bearable. Closer to dinner time I had Lymphadenopathy under both arms, red, swollen then I took another 4 to 5 hours to subside. During this I have sore arm that was slightly swollen. The arm was swollen, the shoulder was swollen and the clavicle area was also swollen and that's my reaction. I work in healthcare and I was just at a point I went to work, I reported the incident and I filed a VARIS report. I talked to my administrator she said I should call Pfizer, let them know. I spoke to my primary doctor, to let him know. I just wanted to report this to someone.""Registered Nurse stated, ""My work place. It was offered in '(Name)' hospital (not clarified)."" Treatment: Registered Nurse stated, ""I took Tylenol. I took it three times and that would have been a '1000 mg' each time (Not clarified).""When probed for the Causality, Registered Nurse stated, ""Yes."" The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/01/2020,,PVT,; NORVASC; ZETIA; ; ; VITAMIN D [ERGOCALCIFEROL]; VITAMIN A [RETINOL]; VITAMIN C [ASCORBIC ACID]; VITAMIN E [TOCOPHEROL]; VITAMIN B1 [THIAMINE]; VITAMIN B2 [RIBOFLAVIN]; NIACIN; VITAMIN B6; ; VITAMIN B12 [CYANOCOBALAMIN]; ;,,Medical History/Concurrent Conditions: Hyperlipidemia; Hypertension,,,"['Erythema', 'Lymphadenopathy', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Rash vesicular', 'Swelling']",1,PFIZER\BIONTECH, 927657,TN,91.0,M,"Slight sore arm; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration from 02Jan2021 09:45 at single dose for Covid-19 immunization. The patient medical history included heart issues. Concomitant medications were not reported. The patient has received other unspecified medications in two weeks. The patient previously took Penecillon and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced slight sore arm on 02Jan2021 (15:45). There was no treatment received for the adverse event. The outcome of event was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PUB,,,Medical History/Concurrent Conditions: Heart disorder,,,['Pain in extremity'],UNK,PFIZER\BIONTECH, 927658,,,U,"Took the COVID vaccine; Rapid Antigen Test turned out positive, PCR test came out negative; Took the COVID vaccine; Rapid Antigen Test turned out positive, PCR test came out negative; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient took the COVID vaccine, and a few days later they took the Rapid Antigen Test, the COVID test. And it turned out positive. The person took other tests as well, PCR test which came out negative. The reporter didn't know if there was any research or data if that was done maybe during clinical trials of whether it is possible to come out positive on an antigen test which tests for bio-protein. The reporter believe that was what in the vaccine. The reporter guess the vaccine causes the reaction in the body to make that protein in the body. The reporter wonder if it was possible it could be false positive on one of those tests because of the vaccine, because of the way that rapid test works. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 927659,,,M,"Got tested positive; Got tested positive; This is a spontaneous report from a contactable nurse from a Pfizer-sponsored program Pfizer First Connect. A male patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, Expiry Date: 31Mar2021), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Transferring agent stated, ""I have a nurse (reporter) on the other line. She is currently on hold. She is reporting an adverse event about COVID Vaccine because she is saying that their doctor (Incomplete sentence). I mean, the nurse on the other line is working at the vaccine clinic. One of their doctors in the clinic had COVID Vaccine on 17Dec2020. I mean, the Doctor got positive or tested positive on 23Dec2020. Should that mean that the COVID Vaccine or the first dose of COVID Vaccine did not take effect for the Doctor itself because the Doctor got positive? They would like to know if they should still need to take second dose of COVID Vaccine."" When paraphrased the concern, reporter stated, ""Correct. And the question is would he need to get his second dose. It is said that it's two doses."" The outcome of the events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event test positive based on the known safety profile. However the short duration of 6 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/23/2020,6.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 927660,MI,,F,"body aches; headache; mild discomfort; This is a spontaneous report from a contactable physician (patient) via a Pfizer sponsored program Pfizer First Connect and Medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her vaccine 02Jan2021 and was experiencing body aches and headache in Jan2021. The patient asked if she can take Tylenol, ibuprofen or Excedrin or some version of a pain reliever. The patient was having mild discomfort in Jan2021. The outcome of the events was unknown. Information about Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/01/2021,,UNK,,,,,,"['Discomfort', 'Headache', 'Pain']",UNK,PFIZER\BIONTECH, 927661,KS,72.0,F,"Blood vessels across forehead were very enlarged like a big varicose vein; very sore to the touch; Every place I touched my head where a blood vessel ran is where the pain was; Terrible chills; Ran the temperature about a 100; Really bad headache; Slight soreness in my arm; Cough; Temporal arteritis; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, Expiry Date: Mar2021), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. Medical history included sinus issues, allergy, hormone replacement therapy. Concomitant medication included estradiol as hormone replacement, metronidazole (METROGEL), vitamins and supplements. Patient stated, ""I had the COVID injection 19Dec, the first one, afterwards there was a slight soreness in my arm to take couple of days, that was it, until this past Monday (28Dec2020) which was the 9th day afterwards, I started having chills, terrible chills, ran the temperature about a 100 and had a really bad headache. Woke up the next day (29Dec2020), I had noticed the blood vessels across my forehead were very enlarged like a big varicose vein and were very sore to the touch. I realized that my headache, every place I touched my head where a blood vessel ran is where the pain was. I've googled all my symptoms and the word that comes up when I read about is - Temporal arteritis. I didn't know if there was any possibility that was connected with that injection. Along with the chills and the fever, I had also had a cough and a headache."" Patient stated, ""I have been taking Ibuprofen two 200 mg tablets, once today and once last night"" as treatment. The outcome of everts was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/01/2020,,UNK,; METROGEL,,Medical History/Concurrent Conditions: Allergy; Hormone replacement therapy; Sinus disorder,,,"['Body temperature', 'Chills', 'Cough', 'Giant cell arteritis', 'Headache', 'Pain in extremity', 'Pyrexia', 'Varicose vein', 'Vascular pain']",1,PFIZER\BIONTECH, 927662,AR,,F,"Anaphylactic reaction; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on deltoid (unknown which) on 31Dec2020 at 0.3 mL, single for COVID-19 immunization. There were no medical history and concomitant medications. The patient experienced anaphylactic reaction on 31Dec2020. The event required emergency room visit for observation and treatment.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reaction cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Anaphylactic reaction'],UNK,PFIZER\BIONTECH, 927663,MI,34.0,M,"feeling like he was going to pass out; throat was really dry within 15 minutes; Was very shaky. He was not falling over but had to be very careful with his steps.; burning sensation like a really bad acid reflux in chest that went to his back; he felt off. It is hard to explain.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), via an unspecified route of administration on 31Dec2020 07:20 at single dose for covid-19 immunization. Medical history included ongoing acid reflux, gout, anxiety depression. Ongoing Concomitant medication included allopurinol from Dec2020 for Gout, fluoxetine hydrochloride (PROZAC) at 20mg daily from Dec2020 2 weeks ago for Anxiety depression, omeprazole from Dec2020 3 weeks ago for Acid reflux (esophageal), calcium carbonate (TUMS ANTACID) from 2019 as needed for acid reflux. He experienced some unusual side effects that were not listed on the web. His boss advised him to call. Within a few minutes on 31Dec2020 after getting the vaccine he was feeling like he was going to pass out but didn't. His throat was really dry within 10-15 minutes on 31Dec2020. He was very shaky. He was not falling over but had to be careful with his steps. After getting the vaccine you have to sit and be monitored for 15 minutes. After that he was ok enough. He thought this was an expected reaction. He usually reacted to things though he didn't know why. He did fine with the flu shot. He had burning sensation like a really bad acid reflux in chest that went to his back on 31Dec2020. His throat was no different compared to like when you were going to get sick. He had drank a ton of water and his throat was still dry. He was not shaky but he felt off. It was hard to explain. Investigation assessment was no. The outcome of shaky and feeling like he was going to pass out was recovered on 31Dec2020, of dry throat was not recovered, of burning sensation was recovering, of others was unknown. Information on Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,UNK,; PROZAC; ; TUMS ANTACID,Acid reflux (esophageal); Anxiety depression; Gout,,,,"['Burning sensation', 'Dry throat', 'Feeling abnormal', 'Presyncope', 'Tremor']",UNK,PFIZER\BIONTECH, 927664,PA,0.75,M,"ate more than usual; vomited; refused to take any daytime naps; Baby had 3 breast feeding sessions after patient received vaccine; This is a spontaneous report from a contactable consumer. This consumer reported information for both mother and baby. This case is the baby report. A 9-month-Old male patient received BNT162B2 (lot number EL0104), transmammary on 30Dec2020 18:45 at 9 Months at single dose for COVID-19 immunization. The medical history was not reported. The patient was not allergies to medications, food, or other products. The concomitant medications were levothyroxine sodium (SYNTHROID), calcitriol, calcium, fish oil and multivitamin. On the day following the vaccine, the baby refused to take any daytime naps, ate more than usual, and vomited on 31Dec2020 10:00 AM. None of these were typical behavior for the baby. Baby had 3 breast feeding sessions after patient received vaccine, and then was eating frozen reserves. We do not know at this point whether the baby will revert to his norm or whether the change in behavior will continue. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not allergies to medications, food, or other products. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020521814 same vaccine, different patient and AE.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,SYNTHROID;,,,,,"['Exposure via breast milk', 'Increased appetite', 'Insomnia', 'Vomiting']",UNK,PFIZER\BIONTECH,OT 927665,MN,,M,"Tested positive for COVID after having received the vaccine; Tested positive for COVID after having received the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 2 patients. This is second of 2 reports. A 7-decade-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiration date Mar2021), via an unspecified route of administration on 19Dec2020 at 0.3 mL, single in the left deltoid for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that on 30Dec2020, the patient tested positive for COVID after having received the vaccine. The reporter said that they had been vaccinating people at their work. The reporter had vaccinated two people now who within about a week after, they tested positive for COVID. The patient was exposed to COVID outside of work. This patient was a healthcare worker (Doctor) in his 60's, weight within normal limits. He seemed healthy. He was fit. He showed up for work everyday. He was vaccinated on 19Dec2020, then tested positive for COVID yesterday, on 30Dec2020. The reporter was wondering if the patient should still get the second dose in 3 weeks, or wait 90 days after tested positive. The reporter needed to know whether to stick with the 21 day time period for the second dose, or wait 90 days. They had been telling people who were already positive, or who had COVID in the past, to wait 90 days to get the vaccine. The reporter had read all of the literature and looked online and could not find any information on this. The outcome of the event ""tested positive for COVID after having received the vaccine"" was not recovered. The event was assessed as non-serious, and unrelated to vaccine by reporter. She did not think, with either of these patients that them getting COVID had anything to do with the vaccine. She thought it was a coincidence and they were obviously exposed prior to receiving the vaccine.; Sender's Comments: Based on the information currently available, the reported event ""tested positive for COVID"" which was further reported as getting COVID by the nurse, was likely related to patient's exposure to SARS-CoV-2 virus prior to vaccination, and unlikely causally related to BNT162B2 vaccine. Further information like confirmative virus genome /nucleic acid detection needed for more meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021001215 Same drug and events, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/30/2020,11.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 927666,,,F,"Got the vaccine and developed COVID; Got the vaccine and developed COVID; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) from a contactable physician. This pharmacist reported similar events for two patients. This is the second of two reports for Infection Control Nurse's daughter. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the vaccine and 10 days later, got COVID, so, she got swabbed on unknown date. The patient was wondering if she needed to start over or if she was okay to get the second dose. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported ""got COVID"", based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.,Linked Report(s) : US-PFIZER INC-2021001217 same reporter/product, similar events, different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PVT,,,,,,"['COVID-19', 'Viral test']",1,PFIZER\BIONTECH, 927667,MN,,M,"Tested positive for COVID after having received the vaccine; Tested positive for COVID after having received the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 2 patients. This is 1st of 2 reports. A 7-decade-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EJ1685, expiration date: Mar2021), via an unspecified route of administration on 18Dec2020 at left deltoid, at 0.3 mL, single for covid-19 immunization. Medical history included ongoing diabetic. Concomitant medication included insulin for diabetic; pioglitazone hydrochloride (ACTOS) for diabetic and all ongoing. The patient received the vaccine on 18Dec2020 and then less than a week later, on 23Dec2020 was positive for COVID. The reporter said that they had been vaccinating people at their work. The reporter had vaccinated two people now who within about a week after, they tested positive for COVID. The patient was exposed to COVID outside of work. This patient was a healthcare worker (Doctor) in his 60's, weight within normal limits. The reported stated that obviously this person was exposed prior to getting the vaccine and was not symptomatic. But she needed to know, should she stick with the 21 day time period for the second dose or wait 90 days. The patient described COVID as the flu with an attitude. He was staying home and resting. The reporter did not think, with either of these patients that them getting COVID had anything to do with the vaccine. She thought it was a coincidence and they were obviously exposed prior to receiving the vaccine. The event was assessed as non-serious, and unrelated to vaccine by reporter. The outcome of the events was not recovered.; Sender's Comments: There is not a reasonable possibility that event ""tested positive for COVID"" is related to BNT162B2 vaccine. Patient most likely was exposed to SARS-CoV-2 virus prior vaccination.,Linked Report(s) : US-PFIZER INC-2021001199 Same drug and events, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/23/2020,5.0,UNK,; ACTOS,Diabetic,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 927668,,,F,"Patient got the vaccine and 10 days later got Covid; Patient got the vaccine and 10 days later got Covid; Sinus drainage; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) from a contactable physician. This pharmacist reported similar events for two patients. This is the first of two reports for Infection Control Nurse. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the vaccine and 10 days later, got COVID. So, the patient got swabbed because of the sinus draining but she was not ill. The patient was not sick she got some sinus drainage. The outcome of event was unknown. The patients were wondering if they need to start over or if they were okay to get the second dose. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. However, the duration of 10 days since the vaccine first dose is short, and it is unlikely patient would have fully developed immunity. Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021001212 same reporter/product, similar events, different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Paranasal sinus hypersecretion', 'Viral test']",1,PFIZER\BIONTECH, 927669,TN,,M,"patient tested positive for COVID 1 week after vaccination; patient tested positive for COVID 1 week after vaccination; This is a spontaneous report from a contactable physician (patient's wife). This physician reported similar events for two patients. This is the second of two reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, on 21Dec2020, single dose, for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient tested positive for COVID on 28Dec2020 (1 week after vaccination). Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/28/2020,7.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 927670,FL,22.0,F,"chills and not feeling very good; chills and not feeling very good; rapid COVID test positive; rapid COVID test positive; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. This case is serious, the other one is non-serious. A 22-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EH9899) intramuscular at left deltoid on 22Dec2020 19:00 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. No other vaccines given at the same time. The patient received a flu shot back between 27th or 28th Nov2020 in her left deltoid. Caller reported getting the COVID vaccine on the 22Dec2020 and feeling fine before that. On the 28Dec2020 she started feeling chills and not feeling very good and that hasn't gone away. The patient went and got a rapid COVID test and it came back positive, not sure if it was because of the vaccine having antigens in it or she came into contact with it or if she just weakened immune system from the shot. The patient wanted to know if that was true. Then stated she and her mom got the COVID vaccine and her mom received it on the 23Dec. On the 29Dec her whole family started to get sick and experiencing the same things she experienced. The patient was not feeling well at the time of the call. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : 2021001266 same reporter/ drug, different patient/event",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/01/2020,,UNK,,,,,,"['Chills', 'Feeling abnormal', 'Malaise', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,OT 927671,PA,39.0,F,"PCR was positive last night; PCR was positive last night; This is a spontaneous report from a contactable Other Health Professional (Patient) reported that a 39-year-old female patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: EH9899 and Expiration Date unknown) via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. The patient's medical history was unknown. The concomitant medications were reported as none. The patient experienced received the Pfizer's COVID Vaccine on 18Dec2020 (later clarified) at work, at (Institution name) and she just wanted to report that on 23Dec2020, her husband developed symptoms, he was positive on the 26Dec2020 and then she was just converted and her PCR was positive last night on 30Dec2020 (later clarified). Patient think her husband exposed then she was exposed. Treatment included Advair is twice a day and albuterol is three times a day. The outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID-19 PCR test positive based on the known safety profile. However the short duration of 12 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity. Of note, the patient was exposure to COVID-19 (her husband developed COVID-19).",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/30/2020,12.0,PVT,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 927672,,33.0,F,"Legs were swollen; had swollen legs like edema; I had a rapid heart rate/Quick heart rate like my pulse, it's not that high but for me it was high it was like 112, 115 as my resting heart rate, it's just been having like heart palpitations; I had a rapid heart rate/Quick heart rate like my pulse, it's not that high but for me it was high it was like 112, 115 as my resting heart rate, it's just been having like heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, expiration date: Mar2021), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. Medical history included patient had sort of allergic reaction not to a vaccine but 'a bad reaction'. There were no concomitant medications. The patient received COVID Vaccine on 18Dec2020 and ended up on Christmas she went to take a bath that was on 24Dec2020 or 25Dec2020 and noticed that her legs were all swollen and she was not used to that at all having swollen legs. She did work on her feet but she wasn't working on her feet for that week, so she just didn't know what was causing the swelling and within the last couple of days in Dec2020 she had a quick heart rate like her pulse, it's not that high but for she it was high it was like 112, 115 as her resting heart rate, so it's just been having like heart palpitations kind of, she just wanted to report that and kind of see if other people were getting that as a symptom possibly from vaccine. She had in her past had sort of allergic reaction not to a vaccine but 'a bad reaction'. She had swollen legs like edema, so she was just hoping. And then the patient stated that she wasn't tired at the starting, so she wasn't tired the same day' (could not be clarified further). No treatment was received for all events. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: Allergic reaction,,,"['Heart rate', 'Heart rate increased', 'Oedema peripheral', 'Palpitations', 'Peripheral swelling']",UNK,PFIZER\BIONTECH, 927673,,,U,"Left side of mouth, like the outer 10 percent of upper lower lip and the corner of my mouth went numb for about 45 minutes; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had a weird little side effect where the left side of mouth, like the outer 10 percent of upper lower lip and the corner of my mouth went numb for about 45 minutes and then completely resolved. The patient asked when giving the second one should the patient expect a similar response. The information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,['Hypoaesthesia oral'],1,PFIZER\BIONTECH, 927674,MA,41.0,F,"chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest in supine); headaches; nasal/sinus congestion; fatigue; dehydration; dizziness; sore throat; GI issues; Sore arm; This is a spontaneous report from a contactable other hcp (patient). A 41-year-old female patient received first dose of BNT162B2 (COVID-19 vaccine, lot number EK5730), via an unspecified route of administration on 28Dec2020 11:00 at single dose on left arm for COVID-19 immunization. Medical history included COVID-19, hyperthyroidism, Grave's Disease, benign PVCs (Premature ventricular contractions), PACs (Premature atrial contraction) from an unknown date and unknown if ongoing, allergies, Penicillin allergy, allergy to pineapple, kiwi and pomegranate, and NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list) from an unknown date and ongoing. Concomitant medication included cetirizine, fluticasone, propylthiouracil. The patient previously took clindamycin and methimazole and experienced drug allergy. On 28Dec2020 the patient experienced sore arm (like flu vaccine) the day of the vaccination. Early the following morning (on 29Dec2020 04:00) developed chills & shivering. Progressed to high fevers (peaked 102.7), tachycardia (noted to be 148 standing, 120's at rest in supine), headaches, nasal/sinus congestion, fatigue, associated dehydration & dizziness. Subsequent sore throat & GI issues. Symptoms lasted 4-5 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included covid test type post vaccination (nasal swab): negative on 02Jan2021, body temperature: high fevers (peaked 102.7) on 29Dec2020, tachycardia: noted to be 148 standing, 120's at rest in supine on 29Dec2020. No treatment received for the adverse events. The outcome of the events was resolved on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,; ;,"Allergy; Allergy to animals (NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list).); Allergy to plants (NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list).); Dust allergy (NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list).); Environmental allergy (NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list).); Fruit allergy; Penicillin allergy; Pollen allergy (NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list).)",Medical History/Concurrent Conditions: COVID-19; Graves' disease; Hyperthyroidism; Premature atrial contraction; Premature ventricular contractions,,,"['Body temperature', 'Chills', 'Dehydration', 'Dizziness', 'Fatigue', 'Gastrointestinal disorder', 'Headache', 'Investigation', 'Oropharyngeal pain', 'Pyrexia', 'SARS-CoV-2 test', 'Sinus congestion', 'Tachycardia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 927675,,,U,"Severe Lightheadedness/Dizziness; Nausea; My hands wouldn't stop shaking; My heart was beating very fast; I cannot move my arm; It is hurting pretty bad and it is kind of swollen; I am feeling like hot again/My ears like my neck was like on fire; I cannot move my arm; It is hurting pretty bad and it is kind of swollen; I cannot move my arm; It is hurting pretty bad and it is kind of swollen; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 11:00 AM at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the vaccine on 30Dec2020 at 11 O' clock. Four minutes after the patient was given this injection and also now the patient mean today (30Dec2020) after like 3 to 4 minutes like it was given to the patient. The patient had severe lightheadedness, dizziness, nausea, hands wouldn't stop shaking, the patient's ears like the patient's neck was like on fire, the patient felt like the patient's heart was beating very fast. The patient mean the patient's arm the patient knew that it will be a little sore from it. But it was more than just like, like the patient cannot move my arm. It was hurting pretty bad and it was kind of swollen and right now the patient was feeling like hot again. The patient asked that what can the patient do. The outcome of the events was unknown. Information about Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,UNK,,,,,,"['Dizziness', 'Feeling hot', 'Heart rate increased', 'Mobility decreased', 'Nausea', 'Pain in extremity', 'Peripheral swelling', 'Tremor']",UNK,PFIZER\BIONTECH, 927676,GA,34.0,F,"feeding flush with increased heart rate 99; feeding flush with increased heart rate 99; B/P114/24; This is a spontaneous report from a contactable nurse. A 34-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular at left arm on 28Dec2020 11:44 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the vaccine at 11:44 AM, approximate 10 mins later (28Dec2020 11:54), the patient complained of (reported as c/o) feeding flush with increased heart rate (HR) 99, respiratory rate (reported as R) 18, blood pressure (B/P) 120/80, oxygen saturation (reported as sats) 99%. On 28Dec2020 11:49 AM, lab data included B/P 114/24, HR 76, R 16, sats 99%, temp 98.1. On 28Dec2020 11:54 AM, lab data included B/P116/75, HR 70. No treatment received for the adverse events. The events outcome was recovered on an unspecified date in Dec2020. No COVID prior vaccination, it was unknown if the patient had been tested for COVID-19 since the vaccination. It was not reported as serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Blood pressure diastolic decreased', 'Blood pressure measurement', 'Body temperature', 'Flushing', 'Heart rate', 'Heart rate increased', 'Oxygen saturation', 'Respiratory rate']",1,PFIZER\BIONTECH,OT 927677,TX,,U,"tested positive for the Covid antigen with no signs or symptoms; tested positive for the Covid antigen with no signs or symptoms; This is a spontaneous report from a contactable consumer(an administrator of skilled nursing facility). A patient of unspecified age and gender received BNT162B2 (Covid vaccine) , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated the pharmacy did a Pfizer vaccine clinic at his facility, stated that after looking at the FAQs he would like to know if they should not expect a positive antigen test after the vaccine, states the reason he was asking was because the patient they tested today(31Dec2020) that got the vaccine tested positive for the Covid antigen with no signs or symptoms. Outcome of event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/31/2020,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 927678,,28.0,F,"Fever the morning after; sore arm; headache; chills; body aches; developed a rash around injection site, chest, neck, and face; developed a rash around injection site, chest, neck, and face; This is a spontaneous report from a contactable other HCP (patient). A 28-years-old female patient (pregnant: No) received first dose bnt162b2 (BNT162B2 lot number: EH9899), intramuscular on Left arm on 30Dec2020 12:00 at single dose for covid-19 immunisation. Medical history included known allergies: Penicillin, Sulfa, Other-medical-history: Allergy induced asthma. No other-vaccine-in-four weeks. No other-medications-in-two weeks. Since 30Dec2020 13:00 Started with sore arm and headache shortly after injection. Since 30Dec2020 6-8 hours later chills and body aches started. At some point in the same time range, developed a rash around injection site, chest, neck, and face. Fever the morning after on 31Dec2020. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Treatment received for AE included Steroid and Benadryl Injection. The event outcome was recovering. No-covid-tested-post-vaccination. The events were non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Allergy; Asthma; Penicillin allergy; Sulfonamide allergy,,,"['Chills', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia', 'Rash', 'Vaccination site rash']",1,PFIZER\BIONTECH,OT 927679,,,U,"given the Covid 19 vaccine and subsequently tested positive for SARS CoV2 a day or so later; given the Covid 19 vaccine and subsequently tested positive for SARS CoV2 a day or so later; This is a spontaneous report from a non-contactable healthcare professional via Pfizer sales representative. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, from an unspecified date, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient was given the COVID 19 vaccine and subsequently tested + for SARS CoV2 a day or so later on an unspecified date. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 927680,MN,47.0,F,"Allergic reaction; Hives on back; Flushed; Chills; Swollen tongue; Burning tongue; This is a spontaneous report from a contactable consumer (patient). This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 07:00 at single dose on left arm for COVID-19 vaccination. There were no medical history and concomitant medications. The patient previously took flu shot. Vaccination Facility Type was hospital. Patient did not receive any other vaccines at time COVID-19 vaccine given and no vaccines given 4 weeks prior. Patient got the Pfizer COVID-19 vaccine on 29Dec2020 and had an allergic reaction to it. Had hives on her back, was flushed, had chills, and swollen tongue on 29Dec2020. There was swelling on either side of tongue not in the center. Swelling seemed to bounce around sides of tongue. Patient mentioned she also had burning sensation of tongue first on 29Dec2020 and then the swelling was after that. Adverse events hives, flushed, chills, burning sensation of tongue and swelling of tongue required a visit to emergency room. Patient was seen in the emergency room and given diphenhydramine hydrochloride (BENADRYL) and an Epi-pen to take home. This all happened after receiving the vaccine on 29Dec2020. Patient wasn't getting any better/feeling better and went back to the emergency room on 30Dec2020. Patient was treated with dexamethasone and told her to take diphenhydramine hydrochloride every 4 hours, her last dose was at 2pm 31Dec2020. Patient said all events still persisting, but there maybe a little more swelling of the tongue, but not much. Patient had had a flu shot before, but never had anything to happen like this. Outcome of allergic reaction, hives, flushed, chills and burning tongue was not recovered, outcome of swollen tongue was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Flushing', 'Hypersensitivity', 'Swollen tongue', 'Tongue discomfort', 'Urticaria']",1,PFIZER\BIONTECH, 927681,WI,,F,"Severe nausea; heaving; vomiting; coughing; fever of 101.2; feeling dizzy; achy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's mother) reported that a female patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. Relevant medical history included mild case of Covid in mid-Nov2020. The patient's concomitant medications were not reported. The patient works at a hospital delivering food to patients rooms. She received her first dose of the vaccine on 30Dec2020 and 12-14 hours later (unspecified date in Dec2020), she started feeling dizzy and achy. This was followed by heaving, vomiting, coughing, and a fever of 101.2 on 31Dec2020. At the time of the report, it was her third day with fever. When receiving her first dose, she was asked if she had a mild case of Covid, or if she was hospitalized and needed an IV drip, and she stated she had a mild case. The reporter wanted to know if the patient should have been given the first dose of the vaccine to begin with. The patient also experienced severe nausea on an unspecified date. The patient underwent further lab tests and procedures, which included a positive corona virus disease (CoVid) test in mid-Nov2020. The outcome of all the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Body temperature', 'Cough', 'Dizziness', 'Nausea', 'Pain', 'Pyrexia', 'Retching', 'SARS-CoV-2 test', 'Vomiting']",1,PFIZER\BIONTECH, 927682,,45.0,F,"sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 45-year-old female patient received first dose of bnt162b2 (BNT162B2 also reported as COVID-19 vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unspecified date at single dose, for Covid-19 immunisation. Medical history included rheumatoid arthritis and allergic reactions (unspecified). Concomitant medications were not reported. After receiving the first dose of the vaccination the patient experienced a sore arm on an unspecified date. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Allergic reaction; RA,,,['Pain in extremity'],1,PFIZER\BIONTECH, 927683,CA,42.0,U,"tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable Nurse reported for self. This 42-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 22Dec2020 08:00 on Left arm at single dose (Lot # EH9899) for covid-19 immunisation. Medical history, concomitant medications were none. The patient tested positive for Covid in 25Dec2020. The patient was scheduled to receive the second dose in 08Jan2021 so should the patient get it. (Further clarified the dates and years). Outcome of the events were unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/25/2020,3.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 927684,IN,47.0,F,"excessive sleeping; Extreme fatigue; temp 100; sore throat; loss of balance; Muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration in the left arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization. The patient's medical history included COVID-diagnosis from Mar2020 that resulted in blood clots and pneumonia both on 2020, and allergies to shellfish, eggs, peanuts. The patient was not pregnant. Concomitant medications included acyclovir [aciclovir], levothyroxine sodium (SYNTHROID), apixaban (ELIQUIS), escitalopram oxalate (LEXAPRO), and bupropion hydrochloride (WELLBUTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Dec2020 06:00, the patient experienced extreme fatigue, temperature of 100, sore throat, loss of balance, muscle weakness, and excessive sleeping. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent other lab tests and procedures which included COVID test nasal swab was negative on 28Dec2020. Outcome of the events was not recovered. The events were considered non-serious by the reporter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/25/2020,2.0,WRK,ACYCLOVIR [ACICLOVIR]; SYNTHROID; ELIQUIS; LEXAPRO; WELLBUTRIN,,Medical History/Concurrent Conditions: Clot blood; COVID-19; Egg allergy; Peanut allergy; Pneumonia; Shellfish allergy,,,"['Balance disorder', 'Body temperature', 'Fatigue', 'Hypersomnia', 'Muscular weakness', 'Oropharyngeal pain', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 927685,NJ,26.0,M,"Left axillary, supraclavicual, and cervical chain lymphadenopathy > 1-week post-injection.; since the vaccination, has the patient been tested for COVID-19?: Yes; since the vaccination, has the patient been tested for COVID-19?: Yes; This is a spontaneous report from a contactable healthcare professional. A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on the left arm on 21Dec2020 20:00 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced left axillary, supraclavicual, and cervical chain lymphadenopathy > 1-week post-injection on 22Dec2020 16:00. in which the patient received no treatment. It was also reported on Dec2020, ""since the vaccination, has the patient been tested for COVID-19?: Yes"". The patient has other pending test. The outcome of left axillary, supraclavicual, and cervical chain lymphadenopathy > 1-week post-injection was not recovered and other events was unknown.; Sender's Comments: Based on the information provided, the COVID-19 test positive are possibly related to drug ineffective of BNT162B2 vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/01/2020,,PVT,,,,,,"['Laboratory test', 'Lymphadenopathy', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 927686,AL,28.0,F,"I have like tingling and it is not really numbness but feels like my hands are asleep; I have like tingling and it is not really numbness but feels like my hands are asleep; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EK5730), via an unspecified route of administration on at single dose for preventive measure for Covid. Medical history included postural orthostatic tachycardia syndrome, migraine, cardiac disorder and ventricular tachycardia. Concomitant medication included sertraline hydrochloride (ZOLOFT), topiramate (TROKENDI XR) and nadolol. The patient stated that on 31Dec2020, ""I have like tingling and it is not really numbness but feels like my hands are asleep"". The patient underwent lab tests and procedures which included weight: 130 lbs on an unspecified date. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PVT,ZOLOFT; TROKENDI XR;,,Medical History/Concurrent Conditions: Cardiac disorder; Migraine; Postural orthostatic tachycardia syndrome; Ventricular tachycardia,,,"['Hypoaesthesia', 'Paraesthesia', 'Weight']",UNK,PFIZER\BIONTECH, 927687,,,U,"One of my partners was the same way, tested positive after getting the vaccine; One of my partners was the same way, tested positive after getting the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 2 patient. This is the second of 2 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Pfizer biontech Covid-19 Vaccine, solution for injection, lot number and expiation date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was tested positive after getting the vaccine. The outcome of the event was unknown. Information on Lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (SARS CoV2 test positive) with BNT162b2 can not be fully excluded.,Linked Report(s) : US-PFIZER INC-2020510419 same reporter/ drug/similar events, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 927688,IL,28.0,F,"Dizziness for hours; vomiting; sleepiness; This is a spontaneous report from a contactable healthcare professional. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the right arm on 30Dec2020 16:00 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient known allergies: amoxicillin. The patient experienced dizziness for hours, vomiting, sleepiness on 31Dec2020 22:00. The patient received no treatment. The outcome of the events was recovering. Information on the lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dizziness', 'Somnolence', 'Vomiting']",1,PFIZER\BIONTECH,OT 927689,,42.0,F,"Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; This is a spontaneous report from a non-contactable nurse. A 42-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the left arm on 19Dec2020 11:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine. The patient experienced deep ache left deltoid at injection site with severe nerve pain when lifting left arm on 23Dec2020 16:30. The patient received no treatment. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/23/2020,4.0,PVT,,,,,,"['Neuralgia', 'Vaccination site movement impairment', 'Vaccination site pain']",1,PFIZER\BIONTECH, 927690,CA,37.0,M,"Following day, had minor lower body half aches and chills; Following day, had minor lower body half aches and chills; Typical arm soreness similar to flu shot.; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH 9899), via an unspecified route of administration in the right arm on 29Dec2020 at 15:45 at a single dose as COVID vaccine. The patient had no other vaccines within four weeks prior to the COVID vaccine, was not diagnosed with COVID prior to vaccination, and was not tested for COVID post vaccination. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. Past drug history included flu shot. On 30Dec2020 at 10:00 AM, the patient experienced typical arm soreness similar to flu shot. The following day, 31Dec2020, he had minor lower body half aches and chills. The patient received no treatment for the events. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,UNK,,,,,,"['Chills', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 927691,AR,35.0,F,"acute mild edema to affected forearm with light bruising of unknown origin without known injury; acute mild edema to affected forearm with light bruising of unknown origin without known injury; unknown origin without known injury, tenderness to touch; Tennis elbow of opposite vaccine extremity around same time as vaccine, just after; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in the right arm on 10Dec2020 in a hospital at a single dose for COVID vaccination. Medical history included anxiety and chronic migraines with aura. The patient has no known allergies. The patient was not pregnant at the time of vaccination, did not receive any other vaccine in four weeks, was not diagnosed with COVID prior to the vaccination, and was not tested for COVID post-vaccination. Concomitant medications included desvenlafaxine succinate (PRISTIQ), bupropion hydrochloride (WELLBUTRIN), and cyclobenzaprine. In Dec2020, the patient had tennis elbow of opposite vaccine extremity around the same time as the vaccine, just after. On 01Jan2021 at 04:00 AM, the patient experienced acute mild edema to affected forearm with light bruising of unknown origin without known injury, tenderness to touch. The patient did not receive any treatment for the events. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect). Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/10/2020,12/01/2020,,PVT,PRISTIQ; WELLBUTRIN;,,Medical History/Concurrent Conditions: Anxiety; Chronic migraine,,,"['Contusion', 'Epicondylitis', 'Oedema', 'Tenderness']",1,PFIZER\BIONTECH, 927692,CO,56.0,M,"fever 103.5; Chills; achy; has no energy; This is a spontaneous report from a contactable consumer (patient's wife). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231), intramuscular (right deltoid) on 30Dec2020 0900, at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient has been in bed since 30Dec2020. The patient was achy, has no energy, and has chills on 30Dec2020. Patient also has a fever with temperature of 103.5 on 31Dec2020. Reporter asked if this was normal. Event outcome for achy and chills was recovered on 31Dec2020, not recovered for has no energy and unknown for fever 103.5.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,,,,,,"['Asthenia', 'Body temperature', 'Chills', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,OT 927693,MI,59.0,F,"Bottom lip is not crooked or nothing like it but inside it is kind of little swelled; Mouth is kind of swollen up; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: Apr2021), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had the COVID shot on Tuesday (29Dec2020) and thinks her mouth is kind of swollen up. Her bottom lip is not crooked or nothing like it but inside it is kind of a little swelled. The patient started experiencing the adverse events in the morning of 31Dec2020. No treatment was administered for the events, and the patient was advised to contact primary healthcare professional. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/31/2020,2.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Lip swelling', 'Mouth swelling']",UNK,PFIZER\BIONTECH, 927695,KS,,F,"stuffy nose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration on 31Dec2020 at single dose for Covid-19 immunization. Medical history included exposed prior to the vaccine. Concomitant medications were not reported. The patient informed that she got the vaccine on 31Dec2020 and was recently told she had been exposed prior to the vaccine. The patient currently has a stuffy nose and was wondering if she should get tested. The outcome of the event stuffy nose was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,,,UNK,,,Medical History/Concurrent Conditions: Suspected COVID-19 (prior to the vaccine),,,['Nasal congestion'],UNK,PFIZER\BIONTECH, 927696,FL,,F,"she woke up sick and was having the same symptoms as her husband so she was positive; she woke up sick and was having the same symptoms as her husband so she was positive; This is a spontaneous report from a contactable pharmacist reported for herself. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller stated that she was a pharmacist and on Tuesday last week that she received the Pfizer BioNTech Vaccine. Stated that her husband tested positive yesterday (on 29Dec2020). Stated that she was positive that she was positive because that was her husband. Stated that she woke up sick and was having the same symptoms as her husband so she was positive. Stated that she was due for second dose in 2 weeks. Stated that she received the vaccine last week and was negative. The patient underwent lab tests and procedures which included covid test: negative in Dec2020. The outcome of the events was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,OTH,,,,,,"['Malaise', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH, 927697,NJ,33.0,F,"1 big whelp that is red, hot to touch on arm/gotten an inflammation; This is a spontaneous report from a contactable pharmacist (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730, Expiration Date 31Mar2021), via an unspecified route of administration into left arm on 29Dec2020 16:45 at 0.3 mL, single for preventive as front line healthcare worker. Medical history included compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, chronic sinusitis (took allergy medication for that). Family medical history was None. No Relevant test. Concomitant medication included fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA-D), levocetirizine dihydrochloride (XYZAL) and montelukast sodium (SINGULAIR). No additional vaccines administered on same date of the BNT162B2. The patient experienced 1 big whelp that is red, hot to touch on arm - immediately after, so around 16:45. They were required to stay in clinic for 15 minutes after receiving it, and it was immediately after 16:45 on 29Dec2020. She didn't believe she received it intramuscularly. She believed the needle was a little short to be the 1 inch needle. Now she had a huge red whelp on left arm where she was vaccinated. She was not sure if she need to report it or not. She also wanted to know if there were studies about alternate routes. If it was not given intramuscularly, would she need to receive an additional dose? It was one big whelp. You can see bumps superficially. It was not where the muscle was. She was quite fat on her arm. It is superficial, right on skin. You would usually have to press on skin if it was intramuscular. This you just press on skin lightly, and it was red. She was not able to answer question about serious criteria for both events. With anything, she probably should not have gotten an inflammation. She does not have a lot or expiration or dose for any of those. Right after administration of injection. No emergency room or physician's office required. The outcome of event was not recovered. lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,ALLEGRA-D [FEXOFENADINE HYDROCHLORIDE;PSEUDOEPHEDRINE HYDROCHLORIDE]; XYZAL; SINGULAIR,,Medical History/Concurrent Conditions: Chromosomal abnormality NOS; Chronic sinusitis (took allergy medication for that); Diabetes; Immunocompromised; Obesity; Respiratory disorder,,,['Vaccination site inflammation'],UNK,PFIZER\BIONTECH, 927698,,,U,"symptomatic of Covid; symptomatic of Covid; inoculated on 15Dec2020; patient was scheduled on 04Jan2021 for 2nd dose; inoculated on 15Dec2020; patient was scheduled on 04Jan2021 for 2nd dose; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via an unspecified route of administration on 15Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was inoculated on 15Dec2020 and currently on 28Dec2020 the patient was symptomatic of Covid. The patient was scheduled on 04Jan2021 for 2nd dose. The outcome of the events symptomatic of Covid was unknown. Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/15/2020,12/15/2020,0.0,UNK,,,,,,['Adverse event'],1,PFIZER\BIONTECH, 927699,NC,50.0,F,"dizziness; itching/small hives on forearm (same side as injection but not at injection site); hives on chin/upper lip; This is a spontaneous report from a contactable pharmacist (patient). A 50-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration (arm right) on 02Jan2021 08:15 at single dose for Covid-19 immunization. Medical history included asthma, hypothyroidism, and migraines. Concomitant medications included cetirizine hydrochloride (ZYRTEC), famotidine, salbutamol (ALBUTEROL), fluticasone propionate (FLOVENT), and fluticasone propionate (FLONASE). The patient previously took Keflex [cefalexin] and experienced drug allergies: hives, angioedema. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 30 minutes after the injection on 02Jan2021 (08:45 AM), the patient experienced dizziness and itching/small hives on forearm (same side as injection but not at injection site). Vital signs were measured, all was normal. It was also reported that 36 hours after the injection, the patient got hives on chin/upper lip. The patient was treated with Benadryl, Pepcid, and Zyrtec to stop itching and resolve the hives. Benadryl was taken at home, upon advice from nurse. The outcome of events was recovered on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ; ALBUTEROL [SALBUTAMOL]; FLOVENT; FLONASE [FLUTICASONE PROPIONATE],,Medical History/Concurrent Conditions: Asthma; Hypothyroidism; Migraine,,,"['Dizziness', 'Pruritus', 'Urticaria', 'Vital signs measurement']",1,PFIZER\BIONTECH, 927700,CA,,M,"got the vaccine within the past 24 hours and resulted positive for the test; got the vaccine within the past 24 hours and resulted positive for the test; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on an unspecified date in 2020 at a single dose for COVID-19 immunization. There were no medical history or concomitant medications. The patient got the vaccine within the past 24 hours and resulted positive for the test, the patient took 48 hours ago like was that going to some adverse reaction like patient had the positive results before knowing the result patient got the vaccine so at present patient was just kind of anxious about what going to happen. Next shot will be due on 20Jan2021. The outcome of events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No,,,"['Anxiety', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 927701,NC,50.0,M,"Minor nausea; Mild Headache; Tiredness; Chills; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK5730), via an unspecified route of administration in the left arm on 18Dec2020 07:00 at a single dose for COVID-19 immunization. The patient was vaccinated in a facility. Medical history included histoplasmosis, degenerative disc disease, and penicillin allergy. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included diclofenac sodium, methocarbamol, diphenhydramine hydrochloride (BENADRYL), and atorvastatin (LIPITOR). The patient did not receive other vaccine in the last four weeks. On 18Dec2020 16:00, the patient experienced minor nausea, mild headache, tiredness, and chills for about 18 hours. The patient did not receive any treatment for the reported adverse events. The outcome of the events was recovered on 19Dec2020 10:00. The report was considered non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,MIL,DICLOFENAC NA; ; BENADRYL; LIPITOR [ATORVASTATIN],,Medical History/Concurrent Conditions: COVID-19 (prior vaccination); Degenerative disc disease; Histoplasmosis; Penicillin allergy,,,"['Chills', 'Fatigue', 'Headache', 'Nausea']",1,PFIZER\BIONTECH, 927702,DC,28.0,F,"Chills; subjective fevers less than 100; fatigue; soreness at injection site; This is a spontaneous report from a contactable physician (the patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 16Dec2020 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 16Dec2020, the patient experienced chills, subjective fevers less than 100, fatigue, and soreness at injection site 24 hours. The clinical outcome of chills, subjective fevers less than 100, fatigue, was recovered on an unspecified date. The clinical outcome of soreness at injection site 24 hours was recovered on 17Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,PVT,,,,,,"['Body temperature', 'Chills', 'Fatigue', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 927703,FL,37.0,F,"tested positive for Covid a week after receiving the vaccine; tested positive for Covid a week after receiving the vaccine; patient stated that she was pregnant; patient stated that she was pregnant; patient stated that she was pregnant; This is a spontaneous report from a contactable nurse (patient) from a Pfizer sponsored program. A 37-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), via an unspecified route of administration on 18Dec2020 at left deltoid for Covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced tested positive for Covid a week after receiving the vaccine on 28Dec2020 (as reported), the patient stated that she was pregnant. The patient underwent lab tests and procedures which included Covid test: positive on 28Dec2020. The outcome of events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/18/2020,0.0,UNK,,,,,,"['Exposure during pregnancy', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 927704,NY,40.0,F,"acute bilateral numbness in my thumb and first 3 fingers, with loss of dexterity; acute bilateral numbness in my thumb and first 3 fingers, with loss of dexterity; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: FK1730, via an unspecified route of administration at Left arm from 19Dec2020 09:15 to 19Dec2020 09:15 at SINGLE DOSE for COVID-19 immunization. Medical history reported as none. Concomitant medication included acetylcarnitine (ACETYL L CARNITIN), magnesium, colecalciferol (VITAMIN D), and probiotics. On 29Dec2020 16:30, the patient developed acute bilateral numbness in her thumb and first 3 fingers, with loss of dexterity. It lasted approximately 30-45 minutes, and then improved somewhat but it continues to be present in all digits. The patient was not diagnosed with COVID-19 prior to vaccination and post vaccination. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/29/2020,10.0,PVT,ACETYL L CARNITIN; ; VITAMIN D [COLECALCIFEROL];,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Fine motor skill dysfunction', 'Hypoaesthesia']",1,PFIZER\BIONTECH, 927705,VA,50.0,F,"vomiting; severe headache; This is a spontaneous report from a contactable nurse. A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH9899, expiry date not reported), intramuscular on 30Dec2020 16:00 at a single dose in the left arm as Covid vaccine. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. The patient had no known allergies; no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no other medications the patient received within 2 weeks of vaccination. Patient received vaccine on 30Dec2020 at 4pm. On 01Jan2021, at approximately 3am, patient woke up with a severe headache, and approximately 6am, patient started vomiting which lasted until after 7pm. The headache was not as intense but it was still there today. Since the vaccination, the patient has not been tested for COVID-19. No treatments received in response to the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The outcome of the events headache and vomiting was reported as recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,,,,,,"['Headache', 'Vomiting']",1,PFIZER\BIONTECH,OT 927706,,,U,"Injection site pain; Muscle pain; Joint pain; Fever up to a 100.2; Nausea; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot: EK9231, via an unspecified route of administration on 01Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated, ""I had the COVID shot today (01Jan2021). This morning I had the first shot of the medicine Covid-19 Vaccine Pfizer. This is what is happening. I had the shot around may be 10-10:30. I felt great all the day and after 7 O?clock I started getting injection site pain, muscle pain, joint pain, and fever up to a 100.2, nausea on 01Jan2021. Is there anything that I can do home for the fever especially? Let me give you the number that I got on my vaccination record card. It is Pfizer EK9231 (not clarified)."" The patient further stated, ""I wanted someone to tell me if I can take Tylenol. Do I have a situation like to go to the hospital?."" The patient was advised to visit the nearest emergency room or can contact the physician as the department is closed. The patient further stated, ""I will probably go to the hospital if I threw or some temperature if it is higher. I got to do something. I got so many symptoms. I had probably 19 in Nov, in Nov I spent three days on bed in Hospital. It is fine now and I was in hospital. I do not know what is happening now. It was good all the day but then at night these things."" The patient underwent lab tests and procedures which included body temperature: 100.2 on 01Jan2020. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['Arthralgia', 'Body temperature', 'Myalgia', 'Nausea', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 927707,,,U,"had the vaccine and later tested positive for COVID-19; had the vaccine and later tested positive for COVID-19; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunisation. Medical history included that the patient previously was positive from the virus COVID-19. The patient's concomitant medications were not reported. The patient that had the vaccine and later tested positive for COVID-19. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,Medical History/Concurrent Conditions: COVID-19 virus test positive,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 927708,IL,52.0,F,"Chills; Shaking; Patient was bad and cold; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231, Expiration Date: 30Apr2021), via an unspecified route of administration in left arm, on 31Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included blood pressure. The patient had unspecified concomitant medications. The patient took this shot on 31Dec2020 at her job at medical center (EDF, environmental service; it's housekeeping). The patient was fine during the daytime. The patient made it to her home and now she got the chills and was shaking on an unspecified date. When the patient was asleep, that is when she started feeling chills and the shake. The patient was bad and cold, and she got a bad chill. The patient wanted to report and asked if it was going to go away. No treatment was administered for the events. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,,,UNK,,,Medical History/Concurrent Conditions: Blood pressure abnormal,,,"['Chills', 'Feeling cold', 'Tremor']",UNK,PFIZER\BIONTECH, 927709,TX,66.0,F,"Pounding heart rate, it is faster than normal; can hear her heartbeat in her ears; Felt like she had fever and felt like kind of warmish; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL0140), via an unspecified route of administration, on 30Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included seasonal allergy, brain aneurysm, psoriasis, diabetic, blood pressure, immunosuppressant, cholesterol, and stent in brain. The patient's concomitant medications included metformin, semaglutide (RYBELSUS), valsartan for blood pressure, acetylsalicylic acid (ASPIRIN), ustekinumab (STELARA) as immunosuppressant for psoriasis, and an unspecified statin for cholesterol. The patient took the COVID vaccine yesterday morning (30Dec2020) at the hospital and she had like a pounding heart rate, it is faster than normal, but it is pounding. The patient can hear her heartbeat in her ears. The patient took her blood pressure and it is normal at 123/78 something like that. Heart rate is an over - little 72, 75, little bit fast but not tachycardia. The patient felt like she had fever and felt like kind of warmish, but her temperature is 98.2. As treatment, the patient took an over-the-counter medication, paracetamol (TYLENOL). The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,; RYBELSUS; ; ASPIRIN [ACETYLSALICYLIC ACID]; STELARA,,Medical History/Concurrent Conditions: Aneurysm cerebral; Blood cholesterol abnormal; Blood pressure abnormal; Brain stent insertion; Diabetic; Immunosuppressant drug therapy; Psoriasis; Seasonal allergy,,,"['Blood pressure measurement', 'Body temperature', 'Feeling hot', 'Heart rate', 'Palpitations']",UNK,PFIZER\BIONTECH, 927710,CA,49.0,M,"Sharp pain and it's going down his neck; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELI1284 or ELI284 [pending clarification], Expiration Date: Apr2021), intramuscular, on 31Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included hypertension. The patient's concomitant medication included losartan for hypertension. On 31Dec2020, the patient had the COVID vaccine and he kept getting a sharp pain and it's going down his neck; it is at the opposite side where the shot was injected. The patient didn't know if it's a side effect. No treatment was administered for the event. The outcome of the event was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Hypertension,,,['Neck pain'],UNK,PFIZER\BIONTECH,OT 927711,NJ,54.0,M,"Ankle Joint Pain; This is a spontaneous report from a contactable physician (patient). A 54-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm from 26Dec2020 14:00 to 26Dec2020 14:00 as SINGLE DOSE for COVID-19 immunization. Medical history included hypertension and allergies. The patient's concomitant medications were not reported. On 28Dec2020, the patient experienced ankle joint pain. On 31Dec2020, the patient was tested for COVID-19 post vaccination via nasal swab and tested negative. The outcome of the event was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/28/2020,2.0,PVT,,,Medical History/Concurrent Conditions: Allergy; Hypertension,,,"['Arthralgia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 927712,FL,,F,"soreness at the injection site.; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is the first of 2 reports. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at 12:00 pm at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced the ""usual reaction"", soreness at the injection site on an unspecified date with outcome of unknown. This report is assessed as non-serious. Patient asked if this was normal and if was ok to use paracetamol (TYLENOL) or ibuprofen (MOTRIN) after getting the vaccine. Outcome of event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021004657 same reporter/drug, similar event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,,,UNK,,,,,,['Vaccination site pain'],UNK,PFIZER\BIONTECH, 927713,CO,27.0,F,"I received high temperature of a 100.1; Muscle aches; muscle pain; Body aches; nausea; I was developing soreness at the injection site of the arm; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration, on 31Dec2020 at 12:20, at a single dose, as preventive measure for COVID. The patient has no relevant medical history. There were no concomitant medications. The patient received the vaccine on 31Dec2020 about 12:20. On the same day, midafternoon, patient developed soreness at the injection site of the arm. The following day (01Jan2021), in the morning, she had a high temperature of a 100.1 along with some muscle aches/ muscle pain, body aches, and nausea. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 927714,GA,68.0,M,"I felt kind of cold; had a little bit of fever; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer stated, she works at university hospital and she got the Covid 19 shot. The side effect, she felt kind of cold and had a little bit of fever, on an unspecified date. The consumer stated, 'I am warm now. When I was at work there, I was in a room and it just got cold to me.' She stated that she is supposed to take the next shot, the date 23Dec2020. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Feeling cold', 'Pyrexia']",1,PFIZER\BIONTECH, 927715,OK,29.0,M,"Cervical and clavicular lymphadenopathy on the left side; Some tenderness in neck; This is a spontaneous report from a contactable physician (patient). A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 17Dec2020 at 11:45, at a single dose, for COVID-19 immunization. The patient had no medical history and no concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. On 27Dec2020, the patient experienced cervical and clavicular lymphadenopathy on the left side (same side as the vaccine shot was received). The patient first noticed some tenderness in neck about 10 days after vaccine was administered. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/27/2020,10.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Lymphadenopathy', 'Neck pain']",1,PFIZER\BIONTECH, 927716,,24.0,F,"Her (consumer) right leg hurts when she sits down; Pain starts shooting down from her arm to her leg; Injection site is red and swollen; Injection site is red and swollen; know it is supposed to be swollen for few days but today it is still swollen, its red. I do have little bit pain on it; Vaccine administrator put the vaccine in the wrong part of the arm; She put further behind her arm; This is a spontaneous report from a contactable consumer. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. Medical history included acne. Concomitant medication included spironolactone for acne. The patient was reporting an adverse reaction to the COVID-19 Vaccine. She had two concerns. One concern was that she found that the vaccine administrator put the vaccine in the wrong part of the arm, she said, she put further behind her arm, these were her words and she complains that her right leg hurts when she sits down. She said, she works 12 Hours a day and the pain starts shooting down from her arm to her leg, the injection site is red and swollen and she was not taking any medication to alleviate the symptoms. On 31Dec2020, it was reported that the patient was little bit concerned the area, she stated, ""I know it is supposed to be swollen for few days but today it is still swollen, its red. I do have little bit pain on it but I was a little bit concerned because I was told by my coworkers and nurses. I am not sure they put it in the right area so I guess the nurse administered the vaccine, she put it like instead of like where they normally put the vaccine, she put it at the side of my arm like, not like behind my arm like normally, I was a little bit of concerned. Another symptom that I have been feeling that whenever I sit down my left leg hurts so much like I have been on my feet like, I am working for 12 hours straight away so I have been working on my feet for pretty much the entire day so every time I sat down only my side hurts, on the side where I take the vaccine, I don't know if there is everything to do with that, it is like tolerable pain but (sentence incomplete)."" No treatment for the events. The outcome of the events injection site is red and swollen was not recovered and unknown for the other events. Information on batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/01/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Acne,,,"['Pain in extremity', 'Product administered at inappropriate site', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",UNK,PFIZER\BIONTECH, 927717,CA,34.0,F,"Severe muscle pain and soreness on opposite side of vaccine.; Pain and soreness to shoulder, arm, neck and back; Pain and soreness to shoulder, arm, neck and back; Pain and soreness to shoulder, arm, neck and back; Pain and soreness to shoulder, arm, neck and back; Range of motion highly affected not responding to self treatments or other meds; This is a spontaneous report from a contactable nurse reporting on herself. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 29Dec2020 at 11:00 AM (at the age of 34 years old) as a single dose for COVID-19 vaccination. Relevant medical history included anxiety. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020, the patient experienced severe muscle pain and soreness on opposite side of vaccine, and pain and soreness to shoulder, arm, neck and back and range of motion highly affected. not responding to self treatments or other meds. The events resulted in a physician's office visit. The patient did not receive any treatment for the events severe muscle pain and soreness on opposite side of vaccine, and pain and soreness to shoulder, arm, neck and back. The patient received treatment for the event range of motion highly affected but it was not responding to self-treatments or other medications. The outcome of the events severe muscle pain and soreness on opposite side of vaccine, and pain and soreness to shoulder, arm, neck and back and range of motion highly affected was not recovered. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Anxiety,,,"['Arthralgia', 'Back pain', 'Joint range of motion decreased', 'Myalgia', 'Neck pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 927718,,,F,"menstrual pain has been magnified; her period came one week early; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (age: 45; unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 21Dec2020 to 21Dec2020 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter/patient is an RN that got vaccinated with the first dose of the COVID vaccine in the 21Dec2020. According to her she had nothing different aside that and her period came one week early, and the menstrual pain has been magnified. She wonders if the vaccine could have caused this. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,,,UNK,,,,,,"['Dysmenorrhoea', 'Menstruation irregular']",1,PFIZER\BIONTECH, 927719,NC,55.0,F,"Body ache / pain; Tiredness; Headache; my head is still throbbing; Muscle pain; Chills; Little bit of nausea; Ear ringing; Left eye was twitching a lot; At 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) solution for injection, intramuscular on her arm on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included neuropathy in feet and thyroid condition. The patient's concomitant medications were not reported. Patient reported she was having some of the symptoms like the body ache and just the normal and not the really difficult symptoms or whatever just the tiredness, headache, muscle pain and chills, and pain and a little bit of nausea but last night her ears were ringing and her left eye was twitching a lot and she hadn't taken her temperature because she really didn't think she had a temperature. Then she decided to go ahead and take it and at 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101 and the information in the packet doesn't say like if she can take Tylenol or Motrin trying to get this headache to go away. The patient did not receive any treatment for the events. Outcome of the event headache was not recovered, ear ringing was recovering, left eye was twitching a lot was recovered, while the other events was unknown. No follow-up activities are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,,,UNK,,,Medical History/Concurrent Conditions: Neuropathy; Thyroid disorder,,,"['Body temperature', 'Chills', 'Fatigue', 'Headache', 'Muscle twitching', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Tinnitus']",1,PFIZER\BIONTECH,OT 927720,MN,57.0,F,"Headache; Dizzy; Fever; Nausea; This is a spontaneous report from a contactable Other HCP (patient herself). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unknown route, on 30Dec2020 at 08:45 at single dose for COVID-19 immunisation. Vaccine location was arm right. The patient was not pregnant. Relevant medical history included hypothyroidism, osteoporosis and COVID-19 (prior to vaccination). No known allergies. Relevant concomitant medications included levothyroxine and alendronate sodium (FOSAMAX). The patient was vaccinated at Workplace Clinic, age at vaccination was 57-year-old. No other vaccine was received in four weeks. Since the vaccination, the patient has not been tested for COVID-19. The patient developed nausea 20 minutes after vaccine (on 30Dec2020, at 09:05), then headache, dizzy, fever started about 2 hours after (on 30Dec2020, at 10:45). The patient was not treated for the events. The outcome from the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,WRK,; FOSAMAX,,Medical History/Concurrent Conditions: COVID-19 (If COVID prior vaccination: Yes); Hypothyroidism; Osteoporosis,,,"['Body temperature', 'Dizziness', 'Headache', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH, 927721,NJ,43.0,F,"Left arm (site of injection) soreness/pain Left underarm; Swollen lymph nodes; This is a spontaneous report from a contactable Nurse (patient herself). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142X-31-21), via an unknown route, on 29Dec2020 at 21:30 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was not pregnant. Relevant medical history included hypothyroidism, hypertension and COVID-19 (prior to vaccination). Relevant concomitant medications included amlodipine. The patient was vaccinated at hospital, age at vaccination was 43-year-old. No other vaccine was received in four weeks. On 30Dec2020 at 12:30 the patient developed 'left arm (site of injection) soreness/pain left underarm' and 'swollen lymph nodes'. Post-vaccination COVID test was not performed. The patient was not treated for the events. She was recovering from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,,,Medical History/Concurrent Conditions: COVID-19 (if covid prior vaccination: Yes); Hypertension; Hypothyroidism,,,"['Lymphadenopathy', 'Vaccination site pain']",1,PFIZER\BIONTECH, 927722,CT,,F,"Flu like symptoms; headache; body aches; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular in Dec2020 (reported as mid-Dec) at single dose for Covid-19 immunization. Medical history included Covid-19 on an unspecified date in 2020 (before vaccination). The patient's concomitant medications were not reported. It was reported that the patient had been ill with COVID earlier in the year and was glad she could receive the vaccination. The patient reported that she had her first shot in mid-Dec and would soon be getting her second. She wasn't sure if she'd have side effects but indicated the 24hours the hospital gave them after vaccination was adequate for her flu like symptoms mainly headache and body aches to pass. She took some Tylenol and felt fine the following day. The outcome of events was recovered on an unspecified date. It was unknown whether patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was also unknown if the patient received other medications the patient received within 2 weeks of vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/01/2020,0.0,PVT,,,Medical History/Concurrent Conditions: COVID-19,,,"['Headache', 'Influenza like illness', 'Pain']",1,PFIZER\BIONTECH,OT 927723,,,U,"fatigue; Severe throat pain, it's hard to swallow any liquid right now; It really hurts to talk; Severe throat pain, it's hard to swallow any liquid right now; It really hurts to talk; Diarrhea; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 30Dec2020 15:20 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had the vaccine two days ago on Wednesday at about 3:20 PM and have been feeling like very fatigue. The patient added ""like I know injection site pain is normal but I have been having diarrhea as well and severe throat pain, it's hard to swallow any liquid right now"". The patient further stated that it started this morning with the throat pain and can't swallow anything and really hurts to talk. The outcome of events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,,,UNK,,,,,,"['Diarrhoea', 'Dysphagia', 'Fatigue', 'Oropharyngeal pain', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 927724,,,F,"feeling some tingling again where she had shingles awhile back; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history included shingles from an unknown date and unknown if ongoing she (had shingles awhile back). The patient's concomitant medications were not reported. The patient previously took Valtrex which she had to stopped taking a day and half before the vaccine. On an unknown date, the patient felt some tingling again where she had shingles awhile back and would like to known if she could go back to Valtrex or would it interfere with the vaccine. Outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Shingles (she had shingles awhile back.),,,['Paraesthesia'],UNK,PFIZER\BIONTECH, 927725,MI,60.0,F,"arm was sore; she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach; inherited some type of reaction like a rash, its itchy; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EJ1685, Expiry Date: Mar2021, via an unspecified route of administration on left arm from 29Dec2020 to 29Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, Hypertension (verbatim: Blood Pressure High), thyroid disorder (verbatim: Thyroid), cholesterol. The patient's concomitant medications were not reported. The patient stated she got her vaccination on 29Dec2020, that's Tuesday and her arm was sore the next day (30Dec2020) but she have inherited some type of reaction like a rash, its itchy, her hands are itching like crazy, she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach that's not so itchy it's the hands that's itchy. The patient was asking what should she do. The outcome of the events was unknown. When asked for treatment for the events, the patient stated, ""I was doing some, I take an Aleve, Aspirin and then I was taking some Benadryl capsule for allergy.""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,UNK,,,Medical History/Concurrent Conditions: Asthma; Blood pressure high (Verbatim: Blood Pressure High); Cholesterol; Thyroid disorder,,,"['Pain in extremity', 'Rash', 'Rash pruritic']",UNK,PFIZER\BIONTECH, 927726,AZ,,U,"I am having the most wicked head pains, headache; This is a spontaneous report from a contactable other healthcare professional (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration from 31Dec2020 to 31Dec2020 as single dose for COVID-19 immunization. The patient's medical and concomitant medications were not reported. The patient stated ""I didn't know what I am experiencing is normal or not but I am having the most wicked and I have high pain tolerance, but I am having the most wicked head pains, headache. Is that normal?"". The outcome of the event was unknown. Information regarding the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,,,UNK,,,,,,['Headache'],UNK,PFIZER\BIONTECH, 927727,TX,81.0,F,"Nausea; Diarrhea; Mild headache; This is a spontaneous report from a contactable consumer (patient herself). This 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 30Dec2020 at single dose for COVID-19 immunisation. No relevant medical history was provided. Relevant concomitant medications included sertraline, levothyroxine and furosemide. Facility where the most recent COVID-19 vaccine was administered was Nursing Home/Senior Living Facility. Age at vaccination was 81-year-old. No other vaccine was received in four weeks. On 01Jan2021 at 12:00 AM, the patient had nausea, diarrhea and mild headache. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/01/2021,2.0,OTH,; ;,,,,,"['Diarrhoea', 'Headache', 'Nausea']",UNK,PFIZER\BIONTECH, 927728,TN,77.0,F,"rash occurred on a recent surgical wound/rash developed on the back crease of her legs and neck/severe rash that got worse/general practitioner got steroids to help with itching; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3246, via an unspecified route of administration to left arm from 02Jan2021 to 02Jan2021 as SINGLE DOSE for COVID-19 immunization. Medical history included spinal surgery and surgical wound, a 7 inch scar along her back/she had spinal surgery and has a 7 inch scar, she had no problems. There were no concomitant medications. The patient reported a rash that developed after receiving vaccine on 02Jan2021. On 03Jan2021, her rash occurred on a recent surgical wound, a 7 inch scar along her back. The rash also developed on the back crease of her legs and neck. She has been managing her symptoms with Benadryl. The patient was asking is others has reported this side effect. The patient is also asking if she can get the second dose of the vaccine. Her surgeon suggested perhaps not receiving second vaccine. It was further reported as, ""got Pfizer COVID-19 Vaccine on Saturday. Next day had a severe rash that got worse. Saw her general practitioner this morning and got steroids to help with itching. No further details provided, wants to know if she should forgo the second shot. The patient stated she was fortunate to get the Pfizer vaccine, later clarified as Pfizer COVID vaccine, Saturday in the early am, then on Sunday, developed a rash over part of her body, she can control with Benadryl, the itching, but the weird part, is a month ago, she had spinal surgery and has a 7 inch scar, she had no problems, like no reaction to glue, but the rash is concentrated down both sides of the scar. She had an appointment with her surgeon today, and showed it to him, since she thought it was unusual, and he said she may not want to take the second dose, it was not a terrible rash all over her body, mainly concentrated to the area of her back, and it is like a little bit on the back of her neck, not even anything she would notice, but it is there. The patient stated she can't get through to the Health Department, and she has a card to say to have the second dose on 23Jan2020, but she can't get through. States thanks so much, this is a miracle event and in a year's time, even if she did get a rash. The rash is a little more pronounced, but she has been rubbing it trying to not scratch, but it doesn't seem to be spreading any at all. States she is healthy. Seeking more information about getting the second dose after experiencing a rash. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/03/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Spinal operation; Surgical wound,,,['Rash pruritic'],UNK,PFIZER\BIONTECH, 927729,,52.0,F,"dizziness; muscle aches; chills; fatigue; subjective fever; sore throat; headache; congestion; This is a spontaneous report from a non-contactable consumer, the patient. This 52-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration from 30Dec2020 (at the age of 52-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included depression from an unknown date and unknown if ongoing and dyslipidaemia from an unknown date and unknown if ongoing. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included citalopram (CITALOPRAM) and atorvastatin (ATORVASTATIN). On 30Dec2020, the patient experienced dizziness, muscle aches, chills, fatigue, subjective fever, headache, congestion and sore throat. The adverse events resulted in a doctor or clinic visit. Therapeutic measures included Tylenol and Nyquil. The clinical outcome of dizziness, muscle aches, chills, fatigue, subjective fever, headache, congestion and sore throat was not resolved. It was also reported that since the vaccination, the patient was tested for COVID-19 on 04Jan2021 via nasal swab, results pending. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,;,,Medical History/Concurrent Conditions: Depression; Dyslipidemia,,,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Nasal congestion', 'Oropharyngeal pain', 'Pyrexia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 927730,VA,31.0,F,"face was kind of swollen/swelling in her cheek and her face on the left side; swelling in her eye; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1284, via an unspecified route of administration from 31Dec2020 to 31Dec2020 as single dose for COVID-19 immunization. The patient has no medical history. The patient's concomitant medications were not reported. On 01Jan2021, the patient experienced face was kind of swollen, have some swelling in her eye and her cheek and her face on the left side. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/01/2021,1.0,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No",,,"['Eye swelling', 'Swelling face']",UNK,PFIZER\BIONTECH, 927731,GA,41.0,F,"Axillary swelling.; Neck and hand pain in the injection arm.; Neck and hand pain in the injection arm.; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular in right arm on 28Dec2020 at single dose for COVID-19 immunization. The vaccine was administered at workplace clinic. There were no medical history and concomitant medications. The patient has no known allergies. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced axillary swelling, neck and hand pain in the injection arm on 29Dec2020. No treatment was given for the events. The outcome of the events was not recovered. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Neck pain', 'Pain in extremity', 'Swelling']",UNK,PFIZER\BIONTECH,OT 927732,,,U,"Severe anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the second of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe anaphylaxis on an unspecified date. The outcome of the event was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003207 same drug/event; different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Anaphylactic reaction'],UNK,PFIZER\BIONTECH, 927733,,,U,"severe anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 6 patients. This is 5th of 6th reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced severe anaphylaxis on an unspecified date. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003207 same drug/event and different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Anaphylactic reaction'],UNK,PFIZER\BIONTECH, 927734,,,U,"severe anaphylaxis; This is a spontaneous report from a non-contactable Consumer. This Consumer reported similar event for six patient. This is 6th of sixth reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe anaphylaxis on an unspecified date with outcome of unknown. No follow-up attempts are possible. Information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003207 same drug/event and different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Anaphylactic reaction'],UNK,PFIZER\BIONTECH, 927735,,,U,"My whole, that really my back, it is not my side, it's like a muscle, all muscle don't tighten up; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date in 2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient just got a shot on Wednesday at the patient's job and over maybe two hours ago, the whole, that really the back, it was not the side, it's like a muscle, all muscle don't tighten up like, so was that, can be one of the side effects, like the joint was (sentence Incomplete). The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Hypotonia'],1,PFIZER\BIONTECH, 927736,NJ,23.0,M,"Chills; headache; fatigue; This is a spontaneous report from a non-contactable other HCP (patient). A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via intramuscular route of administration, on 22Dec2020 at 03:00 PM (at the age of 23 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Dec2020, at 03:00 PM, the patient developed chills, headache, fatigue 24 hours after the 1st dose. Treatment was received for the events chills, headache, fatigue 24 hours after the 1st dose included one Advil standard dose with relief. The outcome of the events chills, headache, fatigue 24 hours after the 1st dose was recovered on unknown date. Since the vaccination, the patient had been tested for COVID-19 (via saliva COVID test) on 30Dec2020 with negative result. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,WRK,,,,,,"['Chills', 'Fatigue', 'Headache', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 927737,,53.0,F,"Headache; Sore arm; Swelling of the feet; This is a spontaneous report from a contactable consumer (patient herself). This 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 23Dec2020 at single dose for COVID-19 immunisation. She was working as a receptionist in a nursing home. Age at vaccination was 53-year-old. No relevant medical history and concomitant medications were provided. On unknown date after vaccination, the patient developed headache, sore arm, and swelling of the feet. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,,,UNK,,,,,,"['Headache', 'Peripheral swelling', 'Vaccination site pain']",1,PFIZER\BIONTECH, 927738,PA,41.0,F,"Fever; Chills; Vomiting; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm from 02Jan2021 08:00 to 02Jan2021 08:00 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 03Jan2021 03:30, the patient experienced fever, chills, vomiting, and diarrhea. The patient underwent lab tests and procedures which included Sars-cov-2 (Nasal Swab) test on Jan2021: with negative result post vaccination. The outcome of the events was recovering. No treatment was given for the events. No follow-up attempts are possible, information about batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,UNK,,,,,,"['Chills', 'Diarrhoea', 'Pyrexia', 'SARS-CoV-2 test', 'Vomiting']",1,PFIZER\BIONTECH, 927739,,,F,"Fever; Soreness in arms; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as vaccine for COVID. Medical history included did have COVID early on. Concomitant medications were not reported. The patient experienced fever, soreness in arms on unspecified dates. She had a vaccine on Wednesday, and she did have a typical side effect- two days of fever and soreness in arms, the typical. Her question was, ""Now, if you have the side effects, the first go around. When I am going to get the second go round, well, how did they go out on the study? Did most people that got them on the first go around get them both?"" She had COVID early on; one would think her body would already have what it needed to, that's why she was surprised that she was getting side effects. The outcome of the events was recovered. Information on the Lot/Batch Number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: COVID-19 (COVID early on),,,"['Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH, 927740,VA,32.0,F,"2 swollen lymph nodes appeared 10 days after vaccination; This is a spontaneous report from a contactable other healthcare professional (hcp). A 32-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH9899, expiry date not reported), via an unspecified route of administration on 22Dec2020 14:30 at a single dose in the left arm for Covid-19 immunization. The patient had no medical history. Patient had no covid prior to vaccination. The patient had no known allergies: no allergies to medications, food, or other products. The patient was not pregnant at the time of the vaccination. The patient had no other vaccine in four weeks. The patient had birth control as other medication in two weeks prior to vaccination. Patient 2 swollen lymph nodes on 30Dec2020 20:30, which was also reported as appeared 10 days after vaccination in the hospital. They were located above left clavicle half way from middle of chest to arm, and easily palpable. No treatment received in response to the event and it resulted to emergency room/department or urgent care. The patient was not tested for COVID post vaccination. The outcome of the event 2 swollen lymph nodes was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/30/2020,8.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Lymphadenopathy'],1,PFIZER\BIONTECH, 927741,IL,55.0,F,"sick; Cold; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 via an unspecified route of administration on 30Dec2020 at a single dose as Covid vaccine. Medical history included did have Covid on unspecified date. There were no concomitant medications. It was reported that the patient got her vaccine Covid shot on the Wednesday (30Dec2020) and now she's sick again on 02Jan2021; she could still smell everything (still smell it again) and could still taste everything, so none of that has gone away. She thought she came up with the cold on 02Jan2021. She was not sure if it was just cold. She had already been and had that her full shot. She had not been tested for Covid again. She asked if she should go tested again. The reason for no lot number was because she didn't know that. That's from work, they could provide the lot. No treatment was received for the events. Lab data included tested for Covid: did have Covid on unspecified date. The outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,UNK,,,Medical History/Concurrent Conditions: COVID-19 (did have Covid),,,"['Illness', 'Nasopharyngitis', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 927742,MO,58.0,F,"second day post vaccine woke w/102.2/ fever fever broke by day 3; first day after vaccine developed chills and the worst headache of my life along w/fatigue; first day after vaccine developed chills and the worst headache of my life along w/fatigue; first day after vaccine developed chills and the worst headache of my life along w/fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old female patient received first single dose of BNT162B2 (Pfizer, lot number: ett9899, exp date not reported), via an unspecified route of administration (vaccine location: Left arm) on 30Dec2020 11:00 for COVID-19 immunization. The vaccine was administered in a hospital. Medical history included osteoarthritis bilateral knees. The patient was not pregnant. Concomitant medication include amoxicillin, clavulanate potassium (AUGMENTIN), ascorbic acid (VITAMIN C ACID), meloxicam, and calcium carbonate (CAL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and there were no other medications within two weeks. On 31Dec2020 22:00, the first day after vaccine, patient developed chills and the worst headache of her life along with fatigue. On 01Jan2021, second day post vaccine, she woke with 102.2 fever; chills were gone, headache mild, fatigue present. The fever broke by day 3 (02Jan2021). No treatment was provided for the events. The events were considered as non-serious by the reporter. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. The patient recovered from the fever on 02Jan2021, chills recovered on 31Dec2020, while outcome of headache and fatigue was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,AUGMENTIN [AMOXICILLIN;CLAVULANATE POTASSIUM]; VITAMIN C ACID; ; CAL,,Medical History/Concurrent Conditions: Osteoarthritis knees,,,"['Body temperature', 'Chills', 'Fatigue', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH, 927743,AZ,63.0,F,"heart rate in the 120's which last 15 minutes while at rest; Left arm deep aching; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in the left arm on 30Dec2020 12:00 at a single dose for COVID-19 immunization at the hospital. Medical history included pulmonary embolism (PE's x 2) and left nephrectomy for kidney cancer (CA). Concomitant medications included apixaban (ELIQUIS), losartan and hctz. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020 18:00, the patient experienced heart rate in the 120's which lasted 15 minutes while at rest and left arm deep aching for 2 days. Outcome of the events was recovered. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,ELIQUIS; ; HCTZ,,Medical History/Concurrent Conditions: Kidney cancer; Nephrectomy; Pulmonary embolism,,,"['Heart rate', 'Heart rate increased', 'Pain in extremity']",1,PFIZER\BIONTECH, 927744,CA,28.0,M,"Congestion; Nostrils are really like dry inside; back was hurting; Body ache; Muscle ache; Sweats; Body fatigue; Sore in arm; This is a spontaneous report from a contactable nurse. A 28-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included antidepressant therapy. Concomitant medication included sertraline hydrochloride (ZOLOFT) as an antidepressant therapy. On 28Dec2020, patient was sore in her arm. On 29Dec2020, the next day patient woke up, she had body fatigue and muscle aches and had the sweats and was fine the next day. On 30Dec2020, Wednesday, the patient's back was hurting and has a body ache. And on 01Jan2021, patient stated she was like super congested. There was no back ache or anything but just has a really bad congestion and stated her nostrils were like really dry inside. Therapeutic measures were taken as a result of congestion, nostrils were like dry inside with spray nose with normal saline and the use of a humidifier. The patient recovered from the event, back pain; has not recovered from the events, congested and nostrils were like really dry; and outcome of all other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,UNK,ZOLOFT,,Medical History/Concurrent Conditions: Antidepressant therapy,,,"['Back pain', 'Fatigue', 'Hyperhidrosis', 'Myalgia', 'Nasal congestion', 'Nasal dryness', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 927745,PA,54.0,F,"Some muscle soreness around injection site. Started about 10 hours after injection and lasted about 24 hours; This is a spontaneous report from a contactable other health care professional. A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 31Dec2020 11:30 at single dose, at left arm for COVID-19 immunization. Medical history included arthritis. On 31Dec2020 21:30, it was reported that the patient experienced some muscle soreness around injection site. Started about 10 hours after injection and lasted about 24 hours. The patient did not receive treatment for the event. The outcome of the event was recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Arthritis,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 927746,WA,40.0,F,"bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; intense migraine; nauseous stomach; I have not been this sick; This is a spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received the first dose of BNT162B2, Lot number: Ek5730, intramuscular on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 24Dec2020 03:00, the patient experienced intense migraine and nauseous stomach. On 24Dec2020 07:00, she started throwing up, chills, legs shaky and her symptoms had lasted from Christmas Eve until 29Dec2020. On 27Dec2020, patient's tongue was burning and two days later she had a bloody tongue. She stated, ""I have not been this sick as far as I can remember it was awful. I am a healthy person I get the flu shot and any vaccine/shot necessary and have never been sick like this"". Since the vaccination, the patient had been tested for COVID-19. She had a nasal swab and SARS cov 2 RNA for which she had a negative result on 29Dec2020. Stated that the test came back negative so these reactions had to be her body fighting off the vaccine. She stated she is no longer puking, no longer shaky or chills but faithfully at 3 am she woke up and had an intense migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. The outcome of the events ""chills"", ""legs shaky"" and ""throwing up/puking"" was recovered on 29Dec2020. The outcome of the other events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/24/2020,,PVT,,,,,,"['Chills', 'Malaise', 'Migraine', 'Nausea', 'SARS-CoV-2 test', 'Tongue discomfort', 'Tongue haemorrhage', 'Tremor', 'Vomiting']",1,PFIZER\BIONTECH,OT 927747,,,F,"Patient's arm hurt (pain at injection site); This is a spontaneous report from a Pfizer sponsored program ""from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on an unspecified date, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient's arm hurt (pain at injection site). Clinical outcome of the adverse event was unknown at time of this report. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination site pain'],UNK,PFIZER\BIONTECH, 927748,AZ,62.0,F,"Itching; This is a spontaneous report from a contactable consumer reporting for herself. A 62-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration in the left upper arm on 02Jan2021 13:00 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced itching on 02Jan2021 with outcome of not recovered. The patient got the COVID vaccine on 02Jan2021 around 1 o'clock. That evening (5-6 hours after getting) the vaccine she started itching and has been itching since then. The itching is on her body, back, and stomach. She has been itching since, it comes and goes. Itching worsened. It also worsens in the evening, night, and morning. As treatment the patient took a baby loratadine (CLARITIN).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Pruritus'],1,PFIZER\BIONTECH, 927749,KS,59.0,F,"Nausea; Migraine headache; Chills; Joint pain; This is a spontaneous report from a contactable Nurse. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 30Dec2020 10:30 at Left arm at single dose for covid-19 immunization. Vaccine was administered at hospital and not administered at military site. Medical history included ongoing spondylolisthesis diagnosed 15-20 years ago and overweight. Her vertebrae were not in physical alignment. The patient was given steroids, but it didn't help. Steroids didn't do anything. There was no name or NDC/Lot/Exp of steroids. The patient no longer has steroids. Her back will hurt when she gains weight. Height was now under 5 feet 5 inches (164 cm). The patient had no family medical history. There were no concomitant medications. No additional vaccines administered on same date of pfizer suspect and no prior vaccinations within 4 weeks. No adverse events follow prior vaccinations. The patient experienced multiple side effects 10 hours after the vaccine and lasted 20 hours. Side effects started 20:00 - 21:00 on 30Dec2020. Side effects were classified as: Nausea, migraine headache, chills, and joint pain. The events was waxing and waning. On 31Dec2020, side effects were 75% gone by 16:00. Joint pain was completely going by 22:00-23:00 on 31Dec2020. Chills were gone between 08:00-09:00 on 31Dec2020. Nausea and migraine headache stayed until 16:00-17:00 on 31Dec2020 and then it went away. At the time of vaccination, there was a low-pressure center coming through. There was also an ice and snowstorm. She was wondering if the headaches and joint pain were due to the weather. The patient took no medication or treatment for spondylolisthesis and wondered if that had something to do with it. The patient really want to have second shot in two weeks. Investigation assessment was no. The outcome of the events was recovered on 31Dec2020. Causality assessment by primary reporter via global introspection was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,Overweight; Spondylolisthesis (Diagnosed with Spondylolisthesis 15-20 years ago. Her vertebrae are not in physical alignment.),Medical History/Concurrent Conditions: Back pain (back will hurt when she gains weight),,,"['Arthralgia', 'Chills', 'Migraine', 'Nausea']",1,PFIZER\BIONTECH, 927750,,,U,"All of a sudden I got flushed in the face; Swelling; This is a spontaneous report from a contactable consumer. A 74-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284), via an unspecified route of administration on 03Jan2021 16:04 at single dose for COVID-19 immunization. The patient's medical history was not reported. It was reported that patient is taking an unspecified blood thinner. The patient reported ""My first Covid-19 Pfizer and had not any symptoms or any problems but all of a sudden got flushed in the face, and started little tiny bit of a swelling on an unspecified date and no problem it is already gone away. The outcome of the events was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,,,UNK,,,,,,"['Flushing', 'Swelling']",1,PFIZER\BIONTECH, 927751,CA,58.0,F,"Severe body ache; it has reached to the back area on both sides; nausea; vomiting; pain below her ribs; Stomach upset; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received bnt162b2 (Covid Vaccine) lot no: EK5730, expiry date: 23Dec2020 (as reported), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. Medical history included pre-diabetes, hypertension, and flu all from unspecified dates. Concomitant medication included losartan and metoprolol succinate both for hypertension, and atorvastatin (LIPITOR) and acetylsalicylic acid (ASPIRIN) both for preventative for stroke. The patient received the Covid vaccine by Pfizer on 18Dec2020. Then on Saturday (unspecified date), the patient started having symptoms like Covid symptoms. She had severe body ache. She stated it has reached to the back area on both sides and she never had this before. She had nausea and vomiting but she only vomited once. At the time of report, she was still sick and stated that she felt like she was not getting well. Patient's causality for the events was yes and explained because she never had this kind of symptoms before. She always had the flu but the severity of it where it goes out below her ribs, she never had that. It was like her stomach was upset and she had the pain below her ribs. The patient had not recovered from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,,,UNK,; ; LIPITOR [ATORVASTATIN]; ASPIRIN,,Medical History/Concurrent Conditions: Flu; Hypertension (Verbatim: Hypertension); Pre-diabetes,,,"['Abdominal discomfort', 'Abdominal pain upper', 'Back pain', 'Nausea', 'Pain', 'Vomiting']",UNK,PFIZER\BIONTECH, 927752,,,F,"This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first vaccine a week ago. It was reported that the patient had a migraine today and wants to know if there's any side effects of any medication or reactions to migraine medication she is taking at onset of migraines only. She wanted to know if she could take it. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,,,UNK,,,,,,['Migraine'],1,PFIZER\BIONTECH, 927753,MA,43.0,F,"I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; discomfort 4-5 on a 0-10 scale; I also noted stollen lymph nodes in my neck, throat, and subclavicular areas.; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142) (Brand: Pfizer), via an unspecified route of administration from 31Dec2020 14:30 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant. The facility type vaccine was Nursing Home/Senior Living Facility. Medical history included hypertension, aneurysm of ascending aorta, erbs-duchenne palsy right arm, asthma, seasonal allergies. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), diltiazem (DILTIAZEM SR), sertraline hydrochloride (ZOLOFT). The known allergies included PCN, bananas, passion fruit. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. 12h post vaccine at 01Jan2021 08:30 AM, patient began having muscle and joint aches throughout her body, discomfort 4-5 on a 0-10 scale. She also noted stollen lymph nodes in her neck, throat, and subclavicular areas. Patient didn't receive treatment for the adverse events. The outcome of events was recovered in Jan2021. Patient didn't experience Covid prior vaccination. She took Covid tested post vaccination, covid test type post vaccination Nasal Swab on 02Jan2021, the covid test result negative. The events were reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,ALLEGRA; Diltiazem SR; ZOLOFT,,Medical History/Concurrent Conditions: Aneurysm of ascending aorta; Asthma; Fruit allergy; Hypertension; Palsy; Penicillin allergy; Seasonal allergy,,,"['Arthralgia', 'Discomfort', 'Lymphadenopathy', 'Myalgia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 927754,IL,28.0,F,"chills; low grade fever; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the right arm on 31Dec2020 11:45 at a single dose for COVID-19 immunization. The patient's medical history included allergies to dairy and infection. Concomitant medication included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) on 10Dec2020 for immunization. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 01Jan2021 06:00, the patient woke up with chills and low grade fever. These were same symptoms as when she had the actual infection. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious by the reporter. The following information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Infection; Milk allergy,,,"['Chills', 'Pyrexia']",1,PFIZER\BIONTECH, 927755,GA,56.0,F,"itching to lower left arm; redness noted in the size of about a half dollar on lower left arm; This is a spontaneous report from a contactable nurse. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899) intramuscular in the left arm on 29Dec2020 at single dose for COVID-19 immunisation. Relevant medical history included hives and allergy to coconut and acetylsalicylic acid (ASA). Concomitant medications were not reported. The patient had been observed and released but she returned at 15:21 on 29Dec2020 with itching to lower left arm and redness was noted in the size of about a half dollar on lower left arm. Corrective treatment taken as a result of the events included 25mg of diphenhydramine orally. Patients vitals were taken (results unknown) and additional observation was done. The patient was left with supervising nurse. The patient was called the following day, 30Dec2020, and she reported that she was doing fine; she recovered from the events on 30Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Food allergy; Hives,,,"['Erythema', 'Investigation', 'Pruritus']",1,PFIZER\BIONTECH,OT 927756,CO,30.0,F,"Fever; aches; fatigue; injection site soreness for 5 days; loss of appetite; This is a spontaneous report from a contactable healthcare professional. A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), intramuscular on left arm on 18Dec2020 16:30 at a single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medication included birth control medication (unspecified) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Prior to vaccination, patient was not diagnosed with Covid-19. On 19Dec2020 at 09:00 AM, patient experienced fever, aches, fatigue, injection site soreness for 5 days and loss of appetite. No treatment was received for the reported adverse events. Since the vaccination, the patient has not been tested for Covid-19. The outcome of the events was recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,,,,,,"['Decreased appetite', 'Fatigue', 'Pain', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 927757,FL,51.0,M,"He is not feeling well; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. He has been participating in the clinical trial for the COVID-19 vaccine and he has been calling his clinical trial site since Tuesday with no response. The patient was not feeling well on an unspecified date. Therapeutic measure was taken as a result of the event and included treatment with ibuprofen (ADVIL). Outcome of the event was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Malaise'],UNK,PFIZER\BIONTECH, 927758,LA,,F,"tested positive for COVID after receiving the COVID Vaccine; tested positive for COVID after receiving the COVID Vaccine; This is a spontaneous report from a contactable other HCP from a Pfizer-sponsored Program Pfizer First Connect. A female patient (sister) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller stated that her sister tested positive for COVID after receiving the COVID Vaccine. Caller stated that her sister is a respiratory therapist and she has it (COVID) at the same time as the caller. Caller's sister tested positive at the same time as the caller on 01Jan2021. Caller's sister received the COVID Vaccine from a different facility from the caller. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/01/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 927759,,26.0,F,"Red blood vessels in eyes, worse in left eye; watery eyes; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), via an unspecified route of administration in the right arm on 29Dec2020 08:15 at a single dose for COVID-19 immunization. The patient's medical history included mild von willebrand's, situational anxiety, allergies to penicillin, and Visian ICL surgery in August. The patient was not pregnant. Concomitant medications included calcium carbonate, famotidine, magnesium hydroxide (PEPCID COMPLETE), ethinylestradiol, etonogestrel (NUVARING), fexofenadine hydrochloride (ALLEGRA), and hydroxyzine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 31Dec2020 07:00, the patient experienced red blood vessels in eyes, worse in left eye. She also had watery eyes. No pain. No treatment was received for the adverse events. Outcome of the events was recovered with sequel. The events were considered non-serious. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,WRK,PEPCID COMPLETE; NUVARING; ALLEGRA;,,Medical History/Concurrent Conditions: Contact lens therapy (Visian ICL surgery in August); Penicillin allergy; Situational anxiety; Von Willebrand's disease,,,"['Lacrimation increased', 'Ocular hyperaemia']",UNK,PFIZER\BIONTECH, 927760,IN,31.0,F,"nausea; slight headache; This is a spontaneous report from a contactable Other-HCP (patient). A 31-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=Bl1284), intramuscular at Left arm on 04Jan2021 16:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included narcolepsy, cataplexy, anxiety. Concomitant medication included oxybate sodium (XYREM), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), doxepin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jan2021, received injection 2 hours later at 07:30 PM, the patient experienced nausea and slight headache. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,XYREM; ADDERALL;,,Medical History/Concurrent Conditions: Anxiety; Cataplexy; Narcolepsy,,,"['Headache', 'Nausea']",1,PFIZER\BIONTECH,OT 927761,GA,22.0,F,"with hives noted to abd, chest, and back area.; redness noted to arm as and around injection site.; patient presented digging at areas and reported itching.; patient reports feeling sleepy.; This is a spontaneous report from a contactable nurse. A 22-year-old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot Eh9899) via Intramuscular on 29Dec2020 at single dose in left arm for COVID-19 immunisation. Medical history and concomitant medications were not reported. Mass vaccine Clinic being held at patients work location. Patient was initially monitored for 15 minutes but returned later at 13:53 (also reported as 14: 53, pending clarification) with hives noted to abd, chest, back area. Redness noted ta arm to around injection site. Patient presented digging at areas and reported itching. Vitals taken and due to presentation patient was given 50mg Diphenhydramine to L gluteal area. Staff present continued to monitor and take vitals for an additional 30 minutes. Patient's redness and largely reduced and itching. Patient reported feeling sleepy. Left In care at charge nurse at facility. Spoke with patient the next day to check on the patient and she reported that the patient said she see. Additional information was the patient slept well but was feeling fine. Treatment for events ""with hives noted to abd, chest, and back area"" ""redness noted to arm as and around injection site"" ""patient presented digging at areas and reported itching"" was included Diphenhydramine. Outcome of events ""redness noted to arm as and around injection site"" and ""patient presented digging at areas and reported itching"" was recovered on 29Dec2020, while outcome of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Pruritus', 'Somnolence', 'Urticaria', 'Vaccination site erythema', 'Vital signs measurement']",1,PFIZER\BIONTECH,OT 927762,TX,54.0,F,"Complained arm where she received vaccine was getting sore and very heavy.; Complained arm where she received vaccine was getting sore and very heavy.; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sales representative. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm on 04Jan2021 morning at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received COVID vaccine this morning (04Jan2021) and complained arm where she received vaccine was getting sore and very heavy. The events took place after use of product. She took Tylenol and stated that she feels better. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Vaccination site discomfort', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 927763,,,F,"Her arm is achy after getting the vaccine; This is a spontaneous report from non-contactable consumer(patient) via Pfizer Sales Representative. A female patient of an unspecified age received BNT162B2 (lot number unknown), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's arm was achy after getting the vaccine on an unknown date. The outcome of the event was unknown. No follow-up attempts are possible, information about lot/batch cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain in extremity'],UNK,PFIZER\BIONTECH, 927764,IL,30.0,F,"palpitations; shortness of breath; ears burning; This is a spontaneous report from a contactable physician. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 04Jan2021 08:00 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced palpitations on 04Jan2021 08:00, shortness of breath on 04Jan2021 08:00, ears burning on 04Jan2021 08:00. All events were nonserious. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. No treatment was received. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. the patient has not been tested for COVID-19 since the vaccination. No allergies to medications, food, or other products. The outcome of the events was resolved in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Burning sensation', 'Dyspnoea', 'Palpitations']",UNK,PFIZER\BIONTECH,OT 927765,MI,52.0,F,"muscle spasming; muscle spasming or twitching; shaking; my muscles are weak; This is a spontaneous report from a contactable nurse (reporting for herself). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685) via an unspecified route of administration, on 20Dec2020, single dose for COVID-19 immunization. Relevant medical history was none. Concomitant medications were not reported. The patient started having like muscle spasming or twitching and like shaking a little bit like her muscles were weak on an unspecified date. Outcome of the events were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,,,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No",,,"['Muscle spasms', 'Muscle twitching', 'Muscular weakness', 'Tremor']",UNK,PFIZER\BIONTECH, 927766,NY,,F,"period two weeks early; This is spontaneous report from a contactable Nurse. This Nurse reported similar events for 3 patients. This is the third of 3 reports, reporting for one of the colleagues. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Registered nurse calling regarding the COVID 19 vaccine. She was wondering if people were reporting if they got their periods early? She got her period two weeks early and mentioned she also has two colleagues who had that as well on an unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021002844 same reporter/drug/AE, different patient;US-PFIZER INC-2021004222 same reporter/drug/AE, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Menstruation irregular'],UNK,PFIZER\BIONTECH, 927767,MD,,U,"hives; This is a spontaneous report from a contactable physician reported for a patient. A patient of unspecified age and gender received first dose of BNT162B2 (Pfizer product, lot number unknown), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced hives that began 24 hours post the first dose of the BNT162B2 vaccine. It resolved with one dose of Claritin. No other symptoms at all. The outcome of the event was resolved. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,['Urticaria'],1,PFIZER\BIONTECH, 927768,TX,31.0,F,"Lightheadedness x 3-4 hours until after eating a full meal; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received first dose of BNT162B2 (Pfizer product, lot number EK9231), intramuscular on 29Dec2020 16:30 at single dose on left arm for COVID-19 immunization. Medical history was none. The patient's concomitant medications included OTC Vitamins/Supplements. No allergies to medications, food, or other products. The patient experienced lightheadedness x 3-4 hours until after eating a full meal on 29Dec2020 16:30. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. No treatment received for the adverse event. The outcome of the event was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['Dizziness'],1,PFIZER\BIONTECH,OT 927769,NY,,F,"period two weeks early; This is Spontaneous report from a contactable Nurse. This Nurse reported similar events for 3 patients. This is a 2nd of 3 reports. A patient of unspecified age and gender started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Registered nurse calling regarding the COVID 19 vaccine. She is wondering if people were reporting if they got their periods early? She got her period two weeks early. Mentions she also has two colleagues who had that as well. States she does not have information to provide for her colleagues and declined to report regarding her colleagues. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021004161 same reporter/drug/AE, different patient;US-PFIZER INC-2021002844 same reporter/drug/AE, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Menstruation irregular'],UNK,PFIZER\BIONTECH, 927770,TN,54.0,F,"Chills; fever; fatigue/tiredness; headache; body aches; diarrhea; nausea; This is a spontaneous report from a contactable pharmacist (patient). A 54-year-old female patient received her first dose of BNT162B2 Lot # EJ1685, via an unspecified route of administration at Arm Left on 30Dec2020 11:00 at single dose for COVID -19 immunization. Medical history included Hypothyroid. She was not pregnant. There were no known allergies. Concomitant medication in two weeks included levothyroxine, mometasone furoate (FLONASE), ibuprofen, iron, biotin, and unspecified ""B"". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Started 03Jan2021 10:00 AM, the patient experienced chills, fever, fatigue, tiredness, headache, body aches, nausea, diarrhea resulted in [Doctor or other healthcare professional office/clinic visit]. No treatment was received for all events. The patient did not have Covid prior vaccination and Covid was not tested post vaccination.The outcome of all the events was not resolved. The pharmacist considered all the events as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/03/2021,4.0,PVT,; FLONASE [MOMETASONE FUROATE]; ; ;,,Medical History/Concurrent Conditions: Hypothyroidism,,,"['Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 927771,MN,33.0,F,"muscle pain; cough; fever/have high fever above 102; injection site pain; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, intramuscular on right arm on 28Dec2020 17:00 at a single dose for COVID-19 immunization. Medical history was reported as none. Patient was not pregnant. Patient has no known allergies. The patient's concomitant medications were not reported. The patient reported she experienced symptoms like fever, injection site pain on 28Dec2020 (also reported as 09Dec2020, for clarification), muscle pain on an unknown date, and cough in Jan2021. She had high fever above 102 on 29Dec2020, one day after the vaccination and on the 5th day she started to cough. Patient did not receive any treatment for the events. Outcome of the events was not recovered. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'Cough', 'Myalgia', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 927772,CA,65.0,F,"Abdominal cramps; ""someone's pulling my hair""; headache; muscle pain; feeling sick; feeling warm; This is a spontaneous report from a contactable Nurse reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unspecified route of administration in the left arm on 02Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included amlodipine (unknown manufacturer) and multivitamins. On 02Jan2021 at 03:00 AM the patient experienced abdominal cramps, ""someone's pulling my hair"", headache, muscle pain, feeling sick, feeling warm with outcome of recovering. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. No follow up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Hypertension,,,"['Abdominal pain', 'Feeling abnormal', 'Feeling hot', 'Headache', 'Malaise', 'Myalgia']",1,PFIZER\BIONTECH, 927773,,,F,"chills; not feeling well; This is a spontaneous report from non-contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration and date at a SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date (the day after the vaccine), the patient had chills and not feeling well. Outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Chills', 'Malaise']",UNK,PFIZER\BIONTECH, 927774,,,U,"felt congested; worried; This is a spontaneous report from a non-contactable nurse. A patient of unspecified age and gender started to received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Jan201, the patient felt congested and worried. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/02/2021,,UNK,,,,,,"['Anxiety', 'Nasal congestion']",UNK,PFIZER\BIONTECH, 927775,,,M,"body aches; headache; This is a spontaneous report from a contactable nurse. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry unknown), via an unspecified route of administration on 22Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced body aches and headache on an unknown date. The outcome of the events was unknown. No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,UNK,,,,,,"['Headache', 'Pain']",UNK,PFIZER\BIONTECH, 927776,NJ,,F,"This health care worker who received the vaccine was happy to get a headache like she normally does with other vaccines; This is a spontaneous report from a non-contactable consumer. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache; it was specified that this health care worker who received the vaccine was happy to get a headache like she normally does with other vaccines. The patient recovered from the event on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,['Headache'],1,PFIZER\BIONTECH, 927777,GA,35.0,F,"fever 101; myalgias; arthralgias; headache; injection site pain; This is a spontaneous report from a contactable physician. A 35-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular in the left arm on 22Dec2020 16:00 at single dose for covid-19 immunisation. Medical history included autoimmune thyroiditis, allergy to Sulfa and amoxicillin; clavulanic acid (AUGMENTIN). The patient had concomitant medications. On 23Dec2020 04:0 the patient experienced fever 101, myalgias, arthralgias, headache and injection site pain with outcome of recovered. The patient received paracetamol (TYLENOL) and Ibuprofen as treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Autoimmune thyroiditis; Sulfonamide allergy,,,"['Arthralgia', 'Body temperature', 'Headache', 'Myalgia', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 927778,,54.0,F,"Starting to get really achy; Temperature is 101.7/ fever; Not feeling well; Injection site swelling; Injection site pain; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at a single for COVID-19 immunization. Medical history were reported as none. The patient's concomitant medications were not reported. On 31Dec2020, the night patient's arm didn't get sore till the night and it started swell at the injection site. Patient knew that the site pain was to be expected. On an unknown date, as the day progressed, patient started to get really achy and had a temperature of 101.7 when checked, she was just not feeling well. Outcome of the events was unknown Information on batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'Malaise', 'Pain', 'Pyrexia', 'Vaccination site pain', 'Vaccination site swelling']",UNK,PFIZER\BIONTECH, 927779,RI,25.0,F,"Neck developed a rash; This is a spontaneous report from a non-contactable consumer (patient). A 25-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EH9899) via an unspecified route of administration in right arm on 18Dec2020 20:30 single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. No allergies to medications, food, or other products reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced neck developed a rash on 20Dec2020 20:00 with outcome of unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/20/2020,2.0,WRK,,,,,,['Rash'],1,PFIZER\BIONTECH, 927780,MA,29.0,F,"strange feeling in my throat; Shaking; I felt like a fever was coming on/temp of 102; fatigue; extremely sore arm; This is a spontaneous report from a contactable nurse, who is also the patient. This 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) via an unspecified route of administration in the left arm on 17Dec2020 at 09:00 at single dose for COVID-19 immunisation. Vaccination facility type: workplace clinic. The patient did not receive other vaccines in four weeks. Relevant medical history included asthma, hypothyroidism, seasonal allergy, allergy to pine nuts and almonds and past drug history included allergy to levofloxacin (LEVAQUIN). Concomitant medications included ethinylestradiol/norethisterone acetate (LOESTRIN), levothyroxine sodium (SYNTHROID), fluticasone furoate (VERAMYST), levocetirizine dihydrochloride (XYZAL) and montelukast sodium (SINGULAIR). On 17Dec2020, within a few minutes of receiving the vaccine, the patient noticed a strange feeling in her throat. The patient stated that it was difficult to describe, but only lasted a minute or so. That night (17Dec2020), as she was getting ready for bed, she felt like a fever was coming on, but she checked her temperature and it was 97.6 (her normal temperature). She woke up around midnight shaking, with a temperature of 102. She took ibuprofen and it came down to 100.8 before she fell back asleep. In the morning, her temperature was down to 98.5 and she did not experience any additional fevers. The only other symptoms she experienced were fatigue and an extremely sore arm. These lasted about two days. The patient recovered from the events strange feeling in her throat on 17Dec2020 and she recovered from the fever on 18Dec2020; the patient recovered from the other events in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient was tested for COVID-19 with a nasal swab on 31Dec2020 which was negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,WRK,LOESTRIN; SYNTHROID; VERAMYST; XYZAL; SINGULAIR,,Medical History/Concurrent Conditions: Allergy to nuts; Asthma; Food allergy; Hypothyroidism; Seasonal allergy,,,"['Body temperature', 'Fatigue', 'Oropharyngeal discomfort', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test', 'Tremor']",1,PFIZER\BIONTECH, 927781,,,F,"Nausea; fevers; chills; body ache; headache; muscle and joint pain; muscle and joint pain; fast heart rate of 92 at resting; injection site pain; extremely fatigue; weakness; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. elt9899) on an unspecified date, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced nausea, fevers, chills, body ache, headache, muscle and joint pain, fast heart rate of 92 at resting, injection site pain, extremely fatigue and weakness. Clinical outcome of the events was unknown at time of this report. The case was assessed as non-serious. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Arthralgia', 'Asthenia', 'Chills', 'Fatigue', 'Headache', 'Heart rate', 'Heart rate increased', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 927782,OK,41.0,F,"Random heart palpitations; tachycardia; mild chest tightness; occasional fatigue; This is a spontaneous report from a contactable other HCP (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), via an unspecified route of administration on 23Dec2020 07:00 at single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies from an unknown date. The patient previously took oxycontin and experienced allergies. Concomitant medications included women multivitamins. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient experienced random heart palpitations, tachycardia, mild chest tightness and occasional fatigue five days after receiving the vaccine on 28Dec2020 12:00. No known underlying health issues before the vaccine. The patient did not receive any treatment for the events. The outcome of the events was not recovered. The events resulted in Emergency room/department or urgent care.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/28/2020,5.0,PVT,,,Medical History/Concurrent Conditions: Seasonal allergy,,,"['Chest discomfort', 'Fatigue', 'Palpitations', 'Tachycardia']",1,PFIZER\BIONTECH, 927783,,,U,"after getting the vaccine concerning hypersensitivity; reported lip swelling; This is a spontaneous report from contactable Physician via Pfizer Sales Representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The physician reported that patient experienced an adverse event after getting the vaccine concerning hypersensitivity and reported lip swelling in a patient after COVID-19 vaccination. The outcome of the events was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Allergy to vaccine', 'Lip swelling']",UNK,PFIZER\BIONTECH, 927784,,51.0,M,"I am still sick; Fever/my fever was up to 101.7. It is down to 99 now but I still have the fever; Chills; Aches; joints ache; Some muscle pain; Headache; Tiredness; Injection side swelled up; feeling poorly; This is a spontaneous report received from a contactable nurse (who is also the patient). A 51-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: 28Dec2020 (as reported)), via an unspecified route of administration, on 28Dec2020, at single dose, as a preventive measure for Covid. Medical history included blood pressure abnormal (reported as blood pressure). Concomitant medication included amlodipine besilate and amlodipine besilate (NORVASC 5 mg) both for blood pressure. The patient reported, ""I received my first dose of Covid19 vaccine on Monday (28Dec2020) and it is now Friday and I am still sick and I am wondering how long these symptoms typically take to get better from because it seems like it is day 5 now so"". When probed for events the patient stated, ""Everything on the list, fever, chills, aches, my joints ache, some muscle pain, headache, tiredness, injection side swelled up. I was not nauseas or anything like that. I still have fever today. I did not get symptoms till like 2 days later and then my fever was up to 101.7. It is down to 99 now but I still have the fever."" The patient mentioned, ""I kind of like started feeling poorly on the 29th (29Dec2020) late at night but on the 30th (30Dec2020) I had fever and everything."" The patient underwent lab tests and procedures which included blood pressure measurement: is always good on an unspecified date, body temperature: 101.7 on 30Dec2020, body temperature: 99 on 01Jan2021 (reported as ""I did not get symptoms till like 2 days later and then my fever was up to 101.7. It is down to 99 now but I still have the fever""), and laboratory test: unknown results on Dec2020 (reported as ""I did go for full series of stuff, checkup but that was more than 2 weeks ago""). The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,UNK,AMLODIPINE [AMLODIPINE BESILATE]; NORVASC,,Medical History/Concurrent Conditions: Blood pressure abnormal,,,"['Arthralgia', 'Blood pressure measurement', 'Body temperature', 'Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Illness', 'Laboratory test', 'Myalgia', 'Pain', 'Pyrexia', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 927785,FL,,M,"soreness at the injection site.; 4 days later symptoms at the injection site got worse, now red and hot and swollen; 4 days later symptoms at the injection site got worse, now red and hot and swollen; 4 days later symptoms at the injection site got worse, now red and hot and swollen; This is a spontaneous report from a contactable consumer (patient wife). This consumer reported similar events for 2 patients. This is the 2nd of 2 reports. A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at 12:00 pm at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced the ""usual reaction"", soreness at the injection site, 4 days later symptoms at the injection site got worse, now red and hot and swollen on an unspecified date with outcome of unknown. This report is assessed as non-serious. Consumer asked if this was normal and if was ok to use paracetamol (TYLENOL) or ibuprofen (MOTRIN) to help bring down the swelling. Outcome of events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021002891 same reporter/drug, similar event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,,,UNK,,,,,,"['Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling', 'Vaccination site warmth']",UNK,PFIZER\BIONTECH, 927786,AZ,61.0,F,"Headache; Nausea; Vomiting; Diarrhea; I just ache all over; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Solution for injection; lot number: EJ1685; expiration date: not known), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included hypertension. The patient's concomitant medications were not reported. The patient had been feeling fine after her last vaccination when she took it at a hospital on 29Dec2020 until today (01Jan2021), in which she experienced headache, nausea, vomiting, diarrhea, and she just ache all over. The patient stated it was not serious and just wanted to make sure she was not supposed to be doing something. The patient did not receive treatment for these reported events. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/01/2021,3.0,UNK,,,Medical History/Concurrent Conditions: Hypertension,,,"['Diarrhoea', 'Headache', 'Nausea', 'Pain', 'Vomiting']",1,PFIZER\BIONTECH, 927787,,,F,"Excruciating left shoulder pain; This is a spontaneous report from a contactable consumer. A female patient (reporter's girlfriend) received a single dose of BNT162B2 (COVID-19 Vaccine, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (Vaccine location: arm left) on an unspecified date for COVID-19 immunization. Medical history included trauma in shoulder, so she got metal in there. The patient's concomitant medications were not reported. The patient, who was a nurse Practitioner, got her vaccine on an unspecified date (reported as Tuesday) in her left arm and she had developed excruciating left shoulder pain. Reporter stated ""it's not cleared, can't really figure it out;"" patient had a history of trauma in that shoulder, so, she has got metal in there, so reporter just wanted to know if the company has heard from any other people complaining the same thing after getting the injection. The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,"Medical History/Concurrent Conditions: Shoulder injury (she has a history of trauma in that shoulder, so, she has got metal in there.); Shoulder operation",,,['Arthralgia'],UNK,PFIZER\BIONTECH, 927788,MA,65.0,F,"shakes; chills; headaches; body aches; general malaise; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not provided) via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included Crohn's disease. The patient's concomitant medications were not reported. The patient previously took pneumococcal vaccine in 2020 (reported as last year) and she got a flu shot every year with no issues. She had no issues with vaccines in the past. Patient stated that she was calling about the Pfizer BioNtech Vaccine EUA. Patient stated that she had 1st dose 21Dec2020 and then she had reaction on 22Dec2020 23Dec2020 and part of 24Dec2020, she was scared to death, she was having shakes, chills, headaches, body aches. Due to this she would like to know if it is okay to get the second dose. Her second dose is schedule for 11Jan2021. On 22Dec2020 she had the general malaise, like she was punk'ed. She was home that night and got the shakes. All side effects ended on 24Dec2020 by dinner time. Patient stated that they didn't give her anything after getting the vaccine, they just gave information like this phone number, and websites. They gave stuff to read. She got the vaccine at (Hospital name). She has had no positive tests for Covid prior to the vaccine. She had 1 negative test at the end of Aug2020, and that was because she went to hospital for a total knee and they did Covid test then. She has had no antibody tests. Patient stated that she did vaccine reaction reporting on the website provided, she did the online reporting. The outcome of the events was recovered on 24Dec2020. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Crohn's disease,,,"['Chills', 'Headache', 'Malaise', 'Pain', 'SARS-CoV-2 antibody test', 'Tremor']",1,PFIZER\BIONTECH, 927789,WA,47.0,F,"tongue swelling; This is a spontaneous report from a contactable nurse. This 47-years-old female nurse reported that she received BNT162B2 (lot EL0140) 1st dose intramuscular at Left Deltoid on 28Dec2020 9:38 for COVID-19 vaccination. Medical history was none. Concomitant drug was not provided. The patient reported in the evening on 28Dec2020, she noticed her tongue swelling. She started to notice her tongue swelling shortly after dinner, probably around 6:30-7 in the evening. She was a little bit on pins and needles regarding this reaction. It happened quite a few hours later after receiving the vaccine. She was thinking should she go to urgent care or emergency room or not. Her tongue was still swollen but it seemed like over the week, the swelling had gotten better. However, the swelling came back. So really overall, the swelling hasn't gotten much better. She hasn't been drooling due to the swelling. She hasn't had issues with eating, drinking, swallowing or breathing. She just had ridges around her tongue. Her tongue felt a little bit heavy. The question she had was how long was this going to take before the swelling went away and was it safe her to take the booster shot (second vaccine)? The swelling was still persisting. The outcome of the event was not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Swollen tongue'],1,PFIZER\BIONTECH,OT 927790,KS,,F,"sunburnt skin on her buttocks/major sunburn; contact dermatitis; It is an inflammatory type thing; Skin reaction; peeling with a major sunburn; a lot of itching; This is a spontaneous report from a contactable consumer (patient's daughter). A 97-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not provided), via an unspecified route of administration in Dec2020 at a single dose as COVID 19 vaccine. The patient's medical history and concomitant medications were not reported. Patient received the vaccine on the 3rd of 4th week of Dec2020 in the facility (assisting living facility) in which she lives. She has experienced ""sunburnt skin"" on her buttocks, also reported as sunburn symptoms on buttocks, since (Dec2020). The PA in the facility indicated/called it to be contact dermatitis and was treating with steroids. Reporter has not been able to look at it and has confidence in what they were saying. The patient felt it was related to the vaccine. Reporter would like to know if Pfizer has seen that kind of skin reaction. It is an inflammatory type thing and was peeling with a major sunburn and a lot of itching. Treatments received in response to the events reported. The outcome of the events sunburnt skin on her buttocks/major sunburn, contact dermatitis, ""an inflammatory type thing"", skin reaction, peeling, and itching was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Dermatitis', 'Dermatitis contact', 'Pruritus', 'Skin exfoliation', 'Skin reaction', 'Sunburn']",UNK,PFIZER\BIONTECH, 927791,WV,38.0,F,"Taste metallic; This is a spontaneous report from a contactable health care professional (patient, a Psychologist). This 38-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730) at single dose via an unknown route at left arm on 04Jan2021 15:45 for Covid-19 immunization. Medical history included sinus infection before getting the covid vaccine and this has never happened; the sinus infection was still ongoing at the moment, it started in Dec2020, she was prescribed amoxicillin for it and she was still completing it. Additional medical history included pernicious anemia, Celiac disease, Hashimoto's disease, Sulfa allergy, and Stevens Johnson syndrome. Patient also reported ""she hasn't had symptoms at all"". She further reported that in the past she has had a reaction to Sulfa, it was about 3 years, due to this she got Steven Johnsons' Syndrome , she was hospitalized because of this, it was not fun 0 out of 0 she would not recommend. She has had no positive test for Covid Prior to the vaccine. She has had 1 negative test, it was May2020. She had no issues with vaccines in the past. She did have an issue with the TB Test, explaining that about 6 years ago, the issue was that she got a reaction from getting the TB Test, she got dermatographic urticaria, she was instructed to never get the test again and to get X rays instead. Patient confirms allergy was to Sulfa like the antibiotic. She had no Lot or Exp it has been discarded. Concomitant drugs included ongoing amoxicillin 500mg 1 capsule by mouth twice a day from 28Dec2020 for sinus infection. Patient began to notice the metallic taste within 15 minutes of receiving the vaccine (onset date on 04Jan2021). She didn't think anything of it till she noticed it stuck around. She just had a bad taste in the mouth. It tastes weirdly metallic. Outcome of the event was not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,UNK,AMOXICILIN,Sinus infection,Medical History/Concurrent Conditions: Celiac disease; Dermatographic urticaria; Hashimoto's disease; Pernicious anemia; Stevens Johnson syndrome (she was hospitalized because of this); Sulfonamide allergy,,,"['Dysgeusia', 'SARS-CoV-2 test', 'Tuberculin test']",1,PFIZER\BIONTECH, 927792,FL,30.0,M,"He received his first dose on 22Dec2020, then on 29Dec2020, he tested positive COVID.; He received his first dose on 22Dec2020, then on 29Dec2020, he tested positive COVID.; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable healthcare professional (patient) reported for himself that a 30-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 22Dec2020, at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The healthcare professional is physician assistant. He received his first dose on 22Dec2020, then on 29Dec2020, his COVID 19 test revealed positive. He is supposed to get a second dose on 14Jan2021. He wondered if he is going to be able to take second dose or not. He doesn't have a prescribing doctor. He got it (vaccine) at work/at the hospital he works at. Outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/29/2020,7.0,PVT,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 927793,,,U,"little bit of a fever 37.8; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced little bit of a fever 37.8 on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,,,UNK,,,,,,"['Body temperature', 'Pyrexia']",UNK,PFIZER\BIONTECH, 927794,AZ,,M,"body aches; fever; headache; chills; This is a spontaneous report from a contactable consumer, who is also the patient. This male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. In Dec2020, the patient experienced body aches, fever, headache and chills; the patient specified that he received the vaccine on 23Dec2020 and for 13 days he had been experiencing body aches, fever, headache and chills. The patient was taking ibuprofen (ADVIL) and he responded well to that, but when it wears off the symptoms return. At the time of the report, the outcome of the events was unknown. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/01/2020,,UNK,,,,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 927795,,40.0,M,"Injection Site Soreness/Pain; This is a spontaneous report from a Non-contactable other HCP. This other HCP reported for a 40-year-old male patient that received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EK5730), intramuscular on 04Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 40-year-old. Vaccine location was Left arm. The patient's medical history and concomitant medications were not reported. The patient experienced Injection Site Soreness/Pain. The event was reported as non serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,,,UNK,,,,,,['Vaccination site pain'],UNK,PFIZER\BIONTECH,OT 927796,MO,49.0,F,"Fatigue; She said it felt like painful poking/""needle pokes"" on the inside of her left elbow and the inside of her left wrist; ""Needle pokes"" on the inside of her left elbow & left wrist. She said what she was experiencing was like pins & needles, but with just the needles.; This is a spontaneous report from a contactable consumer (ophthalmic technician, also patient herself). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 29Dec2020 11:44 at single dose on her left upper arm (non-dominant arm) for COVID-19 immunization. Medical history included ongoing lupus from 1993. The patient had no concomitant medications were received. No additional vaccines administered on same date. No emergency room and physician office were visited. The patient had no prior vaccinations (within 4 weeks). The patient took part in a COVID-19 Vaccine program and had fatigue as a side effect. She received the COVID-19 Vaccine on 29Dec2020 at 11:44AM. Reported she started experienced fatigue at around 7:00-8:00PM. She said she all of a sudden became really tired, like she hit a brick wall. She said she could still do stuff, but was really tired. She said the fatigue lasted about 24 hours. She said she generally experiences fatigue in winter, but this fatigue was more than the usual fatigue. Reported she also experienced ""needle pokes"" on the inside of her left elbow and the inside of her left wrist. She said what she was experiencing was like pins and needles, but with just the needles. She said it felt like painful poking, but the pain was not severe and only lasted a half hour. Reported she recently had full blood work done with her primary care doctor, and all was fine. She said she also had some testing done with her gynecologist, and all was fine, saying there was nothing weird. The patient declined any treatment. The outcome of the event fatigue was recovered on 30Dec2020. The outcome of the event She said it felt like painful poking was recovered on 29Dec2020. The outcome of the rest event was recovered in Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,Lupus erythematosus,,,,"['Arthralgia', 'Fatigue', 'Full blood count', 'Investigation', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 927798,MO,,F,"Fever; Fatigue; Joint pain; Headache; This is a spontaneous report from a contactable consumer (patient's co-worker). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included had the COVID-19 virus 3 weeks before getting the COVID-19 Vaccine in 2020. The patient's concomitant medications were not reported. The patient had a lot of side effects after taking the COVID-19 vaccine: fever, fatigue, joint pain, and headache on unknown date. The outcome of events was unknown. Information requested on Lot/ Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: COVID-19 (had the COVID-19 virus 3 weeks before getting the COVID-19 Vaccine),,,"['Arthralgia', 'Fatigue', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH, 927799,CA,30.0,F,"a little fatigue; minor body aches; her arm was a little sore; This is a spontaneous report from a contactable nurse . A 4-decade-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Was notified on 04Jan2021 while the reporter scrolling on Facebook a friend of her who is a nurse who got the Pfizer COVID-19 vaccine and had side effects. Someone on had asked if the patient had any affects, patient stated a little fatigue and minor body aches. The reporter went back to and took a screenshot of the post that was dated from 23Dec2020. Patient was in her late 30's. Patient received vaccine on 23Dec2020 and she worked at Hospital name. This then triggered her to look into her other nurse friends. Apologizes for not having much information to provide on patient, she hasn't spoken to patient in 6 years. Mentioned that post only mentioned her arm was a little sore, but that was with any vaccine. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,,,PVT,,,,,,"['Fatigue', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 927800,TX,54.0,F,"Fatigue; Fatigue; got pain in her arm/ pain in her arm at the injection site; got pain in her arm/ pain in her arm at the injection site; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Right Upper Arm on 03Jan2021 (around 9:15 to 9:30AM) at single dose for COVID-19 immunization. Medical history included ongoing lupus (diagnosed about 2-1/2 years before 04Jan2021) and fatigue with lupus. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient said later in the evening of 03Jan2021, she got pain in her arm she got the COVID-19 Vaccine. She received her first check-in call after receiving the COVID-19 Vaccine, and at that time she had no pain in her arm. She clarified the pain in her arm at the injection site started in the evening of 03Jan2021. On 04Jan2021 she had fatigue. She stated she got fatigue sometimes with her lupus. No treatment received for the adverse events. No emergency room or physician office involved. The patient reported she saw her rheumatologist and had blood work done. The outcome of pain in arm at the injection site was recovering, of fatigue was not recovered. The information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,OTH,,Lupus syndrome,Medical History/Concurrent Conditions: Fatigue,,,"['Blood test', 'Disease recurrence', 'Fatigue', 'Pain in extremity', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 927801,,53.0,F,"My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; It is just red and swollen and warm; This is a spontaneous from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included hypertension. Concomitant medication included lisinopril for hypertension. On an unknown date, her arm was rather red and huge almost looks like a, not a Hematoma but its about that big. She didn't feel bad otherwise. It was just red and swollen and warm. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,,,UNK,,,Medical History/Concurrent Conditions: Hypertension,,,"['Erythema', 'Feeling hot', 'Peripheral swelling']",UNK,PFIZER\BIONTECH, 927802,NJ,54.0,F,"some arm pain (unspecified) following the injection; shoulder and neck stiffness after going to sleep that night; This is a spontaneous report from a non-contactable nurse. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration on 03Jan2021 (Sunday) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The nurse reported some arm pain (unspecified) following the injection on 03Jan2021 and shoulder and neck stiffness after going to sleep that night. The nurse reported that her arm pain resolved the next day on 04Jan2020. The outcome of event ""shoulder and neck stiffness after going to sleep that night"" was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/01/2021,,UNK,,,,,,"['Musculoskeletal stiffness', 'Pain in extremity']",1,PFIZER\BIONTECH, 927803,,,U,"I feel bad; I feel like having body aches; I have like flu symptoms, I feel I am low; I have like flu symptoms, I feel I am low; This is a spontaneous report from a contactable consumer (patient). This patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 29Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient reported got the vaccine on 29Dec2020 and thinks got the side (sentence incomplete). The patient felt bad, felt like having body aches until today the patient had like flu symptoms. The patient felt low, the patient doesn't know it's just side effects or just regular flu. Outcome was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,,,UNK,,,,,,"['Depressed mood', 'Influenza like illness', 'Malaise', 'Pain']",UNK,PFIZER\BIONTECH, 927804,AK,,F,"experienced increased heart rate; shortness of breath; skin rash; redness; This is a spontaneous report from a non-contactable consumer. This report was received via a sales representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via an unspecified route of administration on an unspecified date in Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known previous allergies or adverse reactions to vaccines. The female healthcare worker experienced increased heart rate, shortness of breath, skin rash and redness 10 minutes after vaccination in Dec2020. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Dyspnoea', 'Erythema', 'Heart rate', 'Heart rate increased', 'Rash']",UNK,PFIZER\BIONTECH, 927805,,,U,"very mild tenderness at injection site; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced no side effects to report so far besides very mild tenderness at injection site on an unspecified date with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 927806,CO,,U,"30 minutes after vaccine, had a really weird taste in mouth for about 2 hours; This is a spontaneous report from a contactable consumer reported for self. This patient started to receive received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Jan2021 11:30 at single dose (believe that the LOT# is EK9231) for covid-19 immunisation. Due date for the next dose: 23Jan2021. Medical history and concomitant medications were none. The patient received vaccine 02Jan2021 at 11:30 am and were required to stay until 11:45, 15 minutes after the dose. The patient left in about 15 minutes after that, so, 30 minutes after vaccine on 02Jan2021 at 12:00, the patient had a really weird taste in mouth for about 2 hours. The patient asked if that is something that has been reported as being common. Outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Dysgeusia'],1,PFIZER\BIONTECH, 927807,,,M,"As the day progressed he realized he couldn't smell as much, he still can smell but not very well; Taste diminished; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). This male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was feeling fine earlier today and as the day progressed he realized he couldn't smell as much, he said he still can smell but not very well and his taste has been diminished as well and he wanted to know if these were possible side effects of vaccine. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Anosmia', 'Hypogeusia']",UNK,PFIZER\BIONTECH, 927809,AL,50.0,M,"Heart was little bit racing; This is a spontaneous report from a contactable physician report for self. This 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 in the morning at single dose for COVID-19 immunization. Medical history included borderline hypertension. There were no concomitant medications. Patient probably took some medication in the past but nothing now. The patient took the vaccine in the morning on 30Dec2020, after took the vaccine he sit in the room for monitoring for 15 minutes, after 1 or 2 minutes patient felt like heart was little bit racing, he didn't have any other problems like no shortness of breath, no difficulty breathing, no rash or anything like that and he took some bottled water and started drinking, few minutes later, it may have lasted for 5 minutes, it subsided. No emergency room or physician office visited. The patient's question was whether he could take second shot or not which is probably given in 3 weeks. The outcome of event was recovered on 30Dec2020. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Borderline hypertension,,,['Palpitations'],1,PFIZER\BIONTECH, 927810,,30.0,M,"Low grade fever; Sore mouth; Sore throat; still so weak; This is a spontaneous report from a contactable nurse (patient). This 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EK5730), via an unspecified routed of administration, on 31Dec2020 at single dose for COVID-19 immunisation. Age at vaccination was 30-years-old. Medical history was none. Concomitant medications included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient just wanted to know how long a low grade fever is in the patients, it's been like three days now she still has low grade fever, mouth sore, sore throat and she is still so weak. The patient was treated with Tylenol. Outcome was not recovered. The reporting nurse considered the events related to the vaccine because the events started after that.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,,,UNK,VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Body temperature', 'Oral pain', 'Oropharyngeal pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 927811,FL,,F,my arm is feeling sore; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the first dose of the vaccine and she wanted to know if she can take Tylenol for the pain on her arm. Her arm is feeling sore. Event outcome was unknown. Information about Lot/Batch has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,,,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 927812,TN,79.0,F,"It is very red on the top and the bottom of the both the hands; Hand rash; This is a spontaneous report from a contactable consumer reporting for the mother. A 79-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, EL3246), via an unspecified route of administration, on 02Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 79-years-old. Medical history included diabetic. Concomitant medications included insulin glargine (LANTUS) and insulin lispro (HUMALOG) for diabetic. The patient got the vaccine on 02Jan2021 and she had no side effects or anything but the morning on 03Jan2021 when she woke up her hands have rash and it is very red on the top and the bottom of her hands, both the hands. She always has lab work done. Outcome was unknown. No treatment was received for the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/03/2021,1.0,UNK,LANTUS; HUMALOG,,Medical History/Concurrent Conditions: Diabetic,,,"['Erythema', 'Investigation', 'Rash']",UNK,PFIZER\BIONTECH, 927813,TX,72.0,M,"Last night I had the severe chills and fever that went up to 100.1; Last night I had the severe chills and fever that went up to 100.1; This is a spontaneous report from a contactable consumer (patient herself). This 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 28Dec2020 on the evening at single dose for COVID-19 immunisation. The patient did not have a relevant medical history and relevant concomitant medications. The patient was vaccinated at hospital, age at vaccination was 72-year-old. On unknown date in 2021 (last night, as reported), the patient had the severe chills and fever that went up to 100.1 (units unknown). Blood work was done about week and half ago and results were not provided. The patient took two paracetamol (TYLENOL) about 11:00 pm last night for the events. The patient verbally stated ''I don't know if I am having a delayed reaction to the vaccine or if I am having some kind of viral infection, something else but I want to report this possible reaction''. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Blood test', 'Body temperature', 'Chills', 'Pyrexia']",UNK,PFIZER\BIONTECH, 927814,PA,44.0,F,"Pain in actual site my shoulder is actually throbbing; Sore throat; This is a spontaneous report from a contactable consumer. A 44Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 02Jan2021 at single dose for COVID-19 immunization. The patient did not have medical history or concomitant medications. Patient informed she received the vaccine, her first round of dose yesterday at 2'O clock (02Jan2021) and she was experiencing pain in her shoulder, that was actually throbbing. She also noticed it within a couple of hours, she had a sore throat. Treatment received included Aleve. At the time of the reporting event outcome was unknown. Information on lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Oropharyngeal pain', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 927815,VA,52.0,F,"fever 99.7; Body ache; Headache; This is a spontaneous report from a contactable nurse reported for self. This 52-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Jan2021 at single dose (LOT# EL1284) for covid-19 immunisation. The patient got vaccine yesterday (01Jan2021) and had a side effect. The patient had a fever 99.7, body ache, headache on 02Jan2021 and wanted to know if can take anything. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/02/2021,1.0,UNK,,,,,,"['Body temperature', 'Headache', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 927816,MN,63.0,F,"Her temp got up to, she think it was to '38.7'; Muscle ache but at the injection site for sure; Neck pain; Chills; headache; This is a spontaneous report from a contactable nurse (patient). This 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK4176), via an unspecified route of administration, on 02Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 63-years-old. Medical history was none. Concomitant medications were unknown. Nurse stated she got her shot yesterday in the morning on 02Jan2021. So, she had had just muscle ache but at the injection site for sure and headache, neck pain and then last night starting around 6 O'clock fever and chills. Her temp got up to, she think it was to 38.7 (not clarified further) was when she finally tried to get out of bed to take it. So, she is taking Tylenol a 1000 mg around the clock every 6 hours. The patient is feeling much better but she doesn't want to go through another night like that. Outcome was unknown. For the reporting nurse fever and chills were related to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'Chills', 'Headache', 'Myalgia', 'Neck pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 927817,,,U,"sore arm; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program Corporate (Pfizer) Social Media Platforms. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on Dec2020. The patient outcome of the event was unknown. This follow-up is being submitted to notify that the batch number is not available despite follow-up attempts made. Follow-up attempt have been completed and no further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/01/2020,,UNK,,,,,,['Pain in extremity'],UNK,PFIZER\BIONTECH, 927819,OR,,F,"Only side effect that she got that's on her arm; This is a spontaneous report from a contactable consumer (patient's sister). This is the second case out of two cases. A female patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The reporter stated her sister got her vaccine at her hospital and also side effects was ''on the arm'' (not clarified). She got this shot in ''the organ'' (not clarified), also had ''organ'' (not clarified). The only side effect that she got that's on her arm. Outcome was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PVT,,,,,,['Limb discomfort'],UNK,PFIZER\BIONTECH, 927820,CA,,U,"Pernio what is known familiarly as Covid toe; gout; Pain and redness in one of the toes on my feet; Pain and redness in one of the toes on my feet; This is a spontaneous report from a contactable physician (patient). This patient of unknown age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, two weeks before the report (Dec2020) at single dose for COVID-19 immunisation and ''on that would been 21st'' (as reported). Medical history and concomitant medications were unknown. On Thursday 31Dec2020 began to experience a pain and redness in one of the toes on the feet. The patient originally thought it was gout and treated it with non-steroidal anti-inflammatory medications but it is gone, it has got better with the anti inflammatory (treatment). It is now come back as the patient gave it another look today (03Jan2021) and the patient is wondering if developed pernio, what is known familiarly as Covid toe. Outcome was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/31/2020,30.0,UNK,,,,,,"['Chillblains', 'Gout', 'Pain in extremity', 'Plantar erythema']",1,PFIZER\BIONTECH, 927821,,,F,"subjective myalgias; severe-symptomatic hypercalcemia; persistent flu-like symptoms; proteinuria; IgA-Kappa MM (multiple myeloma); Initial information received on 30-Dec-2020 regarding an unsolicited valid serious case issued from a literature article. Discussion: Our case is unique in that the patient initially had anormal serum calcium level that had increased rapidly to over 22 mg/dl within a period of 24 hours, had no renal failure or any bone involvement; and had a normal quantitative serum light chain measurement. It is theorized that the inactivated influenza vaccine given prior to presentation unmasked an atypical presentation of MM (Multiple Myeloma). This may be attributed to a vaccination induced cytokine storm, especially IL-6 mediated (Interleukin), that may be the key in the pathophysiology of hypercalcemia related to MM (Multiple Myeloma). This case involves a 65 years old female patient who had IgA (immunoglobulin)-kappa mm (multiple myeloma) (plasma cell myeloma), subjective myalgias (myalgia), severe-symptomatic hypercalcemia (hypercalcemia), persistent flu-like symptoms (influenza like illness) and proteinuria, after receiving vaccine INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient had severe-symptomatic hypercalcemia (hypercalcemia, non-serious), within a period of 24 hours after vaccination. On an unknown date, the patient presented with serious subjective myalgias (myalgia) 5 days following vaccination and was hospitalized for this event. Vital signs were stable. CBC (complete blood count) and BMP (basic Metabolic Panel) were unremarkable. Serum calcium was 10.8 mg/dl. The patient was discharged on supportive therapy. On an unknown date, patient presented a day later with persistent flu-like symptoms (influenza like illness, non-serious event, latency unknown). Laboratory revealed serum calcium being above 22 mg/dl, normal renal function, total protein, albumin, ACE (angiotensin-converting enzyme) levels; clear UA (urine analysis) with no albuminuria; low PTH (parathyroid hormone) and 1, 25-(OH)2 (dihydroxy)-Vitamin D3 levels; elevated PTHrP (Parathyroid hormone-related protein) & viscosity levels. On an unknown date, 24-hour urine collection of patient revealed non-serious proteinuria (550 mg), unknown latency following vaccination. Peripheral blood smear revealed rouleaux formation. CT (computerized tomography) scans of the chest, abdomen and pelvis revealed no obvious malignancy. Quantitative immunoglobulins revealed elevated IgA (immunoglobulin A) (2415 mg/dl), and concurrent suppression of IgG (immunoglobulin G) and IgM (immunoglobulin M) levels. Quantitative serum light chain measurement revealed normal levels of kappa and lambda, with an elevated Kappa: Lambda ratio of 2:1. On an unknown date, the patient's SPEP (serum protein electrophoresis ), UPEP (urine protein electrophoresis) and serum immunofixation test revealed serious IgA-Kappa MM (plasma cell myeloma, medically significant event, latency unknown). Patient was treated with aggressive intravenous crystalloids, loop diuretics, calcitonin, pamidronate, and hemodialysis. Her calcium subsequently normalized to 10.1 mg/dl. Bone-marrow biopsy revealed intracytoplasmic kappa-restricted monoclonal plasma cells that occupied 40% of the marrow. Bone survey was negative for lytic lesions. Patient was started on bortezomib, lenalidomide, dexamethasone and monthly zoledronic acid. At the time of reports, the patient has not recovered from the event plasma cell myeloma, as it was reported that she has not attained remission from myeloma yet. While the patient recovered from the event hypercalcemia and myalgia. The outcome was unknown for the events Influenza like illness and proteinuria. There will be no be information on the batch number for this case.; Sender's Comments: This case concerns a 65 years old female patient who had plasma cell myeloma, hypercalcemia, influenza like illness and proteinuria, after vaccination with INFLUENZA VACCINE. The time to onset is compatible. However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of individual vaccine cannot be assessed.",Not Reported,,Not Reported,Yes,,Not Reported,N,,,,UNK,,,,,,"['Angiotensin converting enzyme', 'Biopsy bone marrow abnormal', 'Blood 1,25-dihydroxycholecalciferol', 'Blood albumin', 'Blood calcium increased', 'Blood immunoglobulin A increased', 'Blood immunoglobulin G decreased', 'Blood immunoglobulin M decreased', 'Blood parathyroid hormone decreased', 'Computerised tomogram abdomen', 'Computerised tomogram normal', 'Computerised tomogram thorax normal', 'Electrophoresis protein abnormal', 'Full blood count normal', 'Haemodialysis', 'Hypercalcaemia', 'Immunology test', 'Influenza like illness', 'Light chain analysis abnormal', 'Light chain analysis normal', 'Metabolic function test normal', 'Parathyroid hormone-related protein', 'Plasma cell myeloma', 'Protein total', 'Protein urine present', 'Proteinuria', 'Red blood cell rouleaux formation present', 'Renal function test normal', 'Rouleaux formation', 'Urine analysis normal']",UNK,UNKNOWN MANUFACTURER,OT 927832,OH,25.0,M,"Fatigue all day after injection, Fevers (tmax 100.7), chills, headache, body ache, nausea began 12-14 hours after injection. Still present 24 hours post injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Lexapro 20 mg,No,None,,None,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 927833,MI,48.0,F,"Pfizer-BioNTech COVID-19 vaccine: Extremely sorry injection site, chills, sweating, body aches, stuffy nose, headache, feeling ""foggy"".",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Claritin D & saxenda,N/a,Asthma,,"Pollen, dander, mold, dust","['Chills', 'Feeling abnormal', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Nasal congestion', 'Pain']",1,PFIZER\BIONTECH,IM 927834,FL,69.0,F,"Injection site is red, swollen, hot. Muscle aches, feverish, headache general malaise. I took Tylenol, Advil and used ice for the headache.. The side effects didn?t start until day after the vaccine. This is the third day post vaccine side effects are starting to subside.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,"Plaquinil, celexa, flexeril, synthroid, prevesid, calcium, buspar",,"Lupus, sjorgens, cancer survivor",Pneumonia,"Numerals, methotrexate","['Headache', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Malaise', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 927835,OH,36.0,F,"On day 5 post vaccination I had some axilla pain in my right arm. I couldn't see anything - no redness, nothing swollen, just some pain. It did not warrant medication to be treated. Then on post vaccination day 6, I woke up in the middle of the night to an inflamed area at my vaccination site and by morning the area had spread. As of now it is measuring at 4 cm and is raised, swollen, red, and mildly itchy. From 1/7 to 1/8 it has not changed and may be mildly improved. As a pharmacist, I wanted to report since it seemed to happen beyond the 72 hrs described in the common adverse events reported. As of 1/8, I can still sense the axilla pain but it is not as bad.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/06/2021,6.0,PVT,sertraline 75 mg PO daily,none,"anxiety, but overall very healthy",,none,"['Axillary pain', 'Injection site erythema', 'Injection site inflammation', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 927836,NC,21.0,F,"Vaccine was administered 12/30/2020 and as of 930am 12/31 I was throwing up and running a fever. I left work at 10:30 after realizing how bad I felt and went home. I slept for roughly five hours, from 11am to 3:30ish and then continued to throw up. I could not life my arm past my chest because it was so swollen and sore. I stayed at home and skipped new year's, going back to sleep around 1030pm. It was not fun",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,Birth control,,,,"Penicillin, sulfa drug","['Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Vomiting']",1,MODERNA, 927837,UT,27.0,M,"High grade fever, body aches, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Propranolol, hydrocodone",,Crohns disease,,,"['Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 927838,NC,39.0,F,Swollen Lymph node under right arm size of orange,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,PVT,"Synthryoid, Armor, Creon",none,"graves, Hashimoto",,"Erythromycin, Morphine",['Lymphadenopathy'],1,PFIZER\BIONTECH,IM 927839,TX,42.0,F,Report HA that improved with Tylenol,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,['Headache'],2,PFIZER\BIONTECH,IM 927840,OH,33.0,F,"Pain at site in injection arm followed by increasing redness, warmth, swelling and hardness surrounding injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/07/2021,9.0,PVT,none,none,none,,none,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 927841,,41.0,F,"Patient received COVID-19 vaccine. After receiving vaccine patient c/o nausea and feeling ""something in throat"". Vital signs obtained at 1853 175/96, HR 68, temp 98.3 and o2 sat 99%. Repeat VS at 1903 167/103, HR 78, O2 sat 100%. Having pulse ox desaturations while speaking. Patient transported to ED in stable condition. Patient monitored in ED with resolution of symptoms and was discharged.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,reported penicillin allergy but tolerates amoxicillin,"['Blood pressure increased', 'Nausea', 'Oropharyngeal discomfort']",1,PFIZER\BIONTECH,IM 927842,KY,54.0,F,"Can?t raise arm or sleep in that side, chills, fever, horrible headache, achy, queasy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,Valsartan,No,Hypertension,Flu symptoms,No,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,SYR 927843,FL,66.0,F,She verbalize she develop pain in left leg and dizziness. She was evaluated onsite by Fire Rescue and released home feeling better at 9:51 am.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,Lizinophil 20 mg,HBP,None,,None,"['Dizziness', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 927844,CT,52.0,F,"Moderna COVID-19 Vaccine EUA Swelling, red rash, warm to touch and itchy at vaccine site beginning 1 week after vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"levothyroxine, progesterone, estrogen, alendronate, Restasis eye drops fish oil, Ocuvite, multivitamin, melatonin",none,osteoporosis spine/nerve pain,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA,IM 927845,GA,38.0,F,"Severe pain in the arm after injection, nausea, and still having hives to the site after 8 days later",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PUB,Adderall 15 mg once a day Allegra 180 mg in am Zyrtec 10 mg at night,,Asthma,,"Penicillin, Levaquin, Doxycycline,","['Asthma', 'Injection site urticaria', 'Nausea', 'Pain in extremity']",1,MODERNA,IM 927846,,33.0,F,"1 day after COVID shot #1, she experienced vomiting lasting 18 hours with spontaneous resolution. She notified V-SAFE and was directed to get COVID-19 testing - result negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/17/2020,1.0,MIL,,,,,,"['SARS-CoV-2 test negative', 'Vomiting']",1,PFIZER\BIONTECH,IM 927847,UT,54.0,F,"approx 1 week after vaccine administration, injection site became red and indurated, tender to touch approx 5 inches x 4 inches around. border drawn around it and it was noted to spread beyond bounds. PCP ordered Keflex antibiotic for treatment",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,Keflex,cold and other minor illnesses,,,None,"['Injection site erythema', 'Injection site induration', 'Injection site pain']",1,MODERNA,IM 927848,PA,45.0,M,I noticed a lump above my left clavical. Not sure if it is a swollen lymphnode. It is painful to palpation and still present.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/01/2021,4.0,WRK,none,none,MS,,none,"['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 927850,PA,44.0,F,"Abdominal pain, light headedness, headache started on 01/01/2021. All other symptoms resolved but persistent, significant headache has not resolved yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/01/2021,3.0,UNK,"Prevacid, Pepcid, oral contraceptive",,Gerd,,,"['Abdominal pain', 'Dizziness', 'Headache']",1,MODERNA,IM 927851,TX,67.0,M,Sore arm where Vacine was injected the next morning,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Bystolic,None,None,,None,['Injection site pain'],UNK,MODERNA, 927852,NJ,39.0,F,About 3 minutes after I received the vaccine I became flushed for just a few moments and had a strange taste in my mouth. I could feel a tingle in my mouth at the same time. I became panicked of course but the flushing quickly subsided. The mouth sensation lasted a bit longer but there was no airway compromise at all.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,D?TERRA LLV vitamins Vitamin D3 Black seed cumin oil Turmeric Probiotic,None,None,,Augmentin,"['Flushing', 'Paraesthesia oral', 'Taste disorder']",1,PFIZER\BIONTECH,IM 927853,NY,59.0,F,"Around the injection site there is a raised red, painful, warm and itchy spot. It started on 01/07/21 last night it was a 2 "" x 2"" area. This morning it is 3"" x 4"".",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,OTH,amlodipine 2.5 mg daily ; atorvastatin 10 mg every other day; propranolol er 80 mg daily; duloxetine hcl dr 60 mg daily; vitamin d3,,"hx of breast cancer. high blood pressure, high cholesterol, migranes",,tetracycline/tramicyine,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,SYR 927854,OH,58.0,F,"Had itching and tingling in left arm on 1/7/2021. That evening noticed red, raised, warm area about the size of a baseball at sight of injection. Treated with cortisone cream which seemed to improve somewhat.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,OTH,"Multivitamins, Vitamin D3, Gingko Biloba, Magnesium",None,None,,"Erythromycin, Bactrim - Rash","['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Paraesthesia', 'Pruritus']",1,MODERNA,IM 927855,NY,32.0,F,"CHILLS, HEADACHE, BODY ACHE, SORE IN VACCINE AREA, NAUSEA, DIARRHEA,COUGH",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,"IRON, VITAMIN C",,,,,"['Chills', 'Cough', 'Diarrhoea', 'Headache', 'Injection site pain', 'Nausea', 'Pain']",UNK,PFIZER\BIONTECH, 927856,NJ,61.0,F,"At approximately 3:30 pm the next day (27 hours later), I noticed significant tearing from both eyes, while outside walking. When I returned home, and checked in the mirror, I noticed significant puffiness around the eyes (though not to the point of closure or impaired vision), especially in the inner corners (L>R). I contacted my PCP at 4:45 pm and was instructed to go to the Urgent Care. I was seen there and evaluated, then was discharged without any treatment plan. I had no other symptoms and felt great, and even felt the puffiness had subsided a little bit by the time I left the clinic. Today, 1/8/2021, at 7:30 am awakening, the eyes are quite puffy again, and my nose actually appears a bit swollen on the sides near the eyes. I hear clicking sounds in my sinuses and have a small amount of sinus pressure. I applied ice packs to the eye lids in an effort to reduce swelling, which seems to help a little. Please note that I had botox in my forehead and around the outside corners of the eyes, and dermal filler under the eyes (12/7/2021), this being the first time for the filler.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,Fluoxetine Nutrafol Cucurmin Milk Thistle vitamin d3,,fibrotic liver due to shunt (single blood supply - unknown etiology),"60 years of age at the time of the second shingrix vaccination on 1/16/2020. Flu-like symptoms with fever, headaches, malaise pr",Sulfa drugs,"['Lacrimation increased', 'Paranasal sinus discomfort', 'Periorbital swelling']",1,MODERNA,IM 927857,MO,33.0,M,"Rapid swelling, redness, itching, and warmth developed in the exact location of the injection. Swelling was egg-shaped, approximately 3 cm x 4.5 cm. Subsided over the course of three days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/26/2020,8.0,PVT,Glucosamine - chondroitin,None,TB positive skin reaction. No history of infection,,Banana,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 927858,NC,43.0,F,"rash on chest and back - light red, mildly itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,PVT,"gabapentin, losartan, buspar, prozac, allegra, singulair",,"multiple sclerosis, hypertension, chronic sinusitis",,Benazapril,"['Rash', 'Rash erythematous', 'Rash pruritic']",UNK,PFIZER\BIONTECH,IM 927859,NY,39.0,F,Numbness and tingling on whole left side of body from head to toes on side vaccine was administered. Swelling to left arm/hand.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,Allegra Tylenol Motrin,none,none,,none,"['Hypoaesthesia', 'Oedema peripheral', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 927860,TX,41.0,F,"Symptoms - ? EE reports pain at injection immediately after injection. EE reports ?nickel size? knot on her arm almost immediately after, worsening to 2x2 size this morning (1/8). 1/7 morning: body aches, chills, feelings of unwell. Unsure of fever as she has been rotating Tylenol and motrin. EE reports she saw RN at campus this morning for inspection of injection site. Home remedies? - ice pack to injection site and rotating Tylenol (last dose 20:30 1/7) and motrin (last dose 23:00 1/8) Any improvement? ? mild improvement Recommendation? EE encouraged to continue to ice injection site and to rotate Tylenol and motrin. EE encouraged to continue to monitor symptoms and to call vaccine support with further questions and/or concerns. EE denied history of COVID-19 exposure without proper PPE and denied recent travel. EE educated to manange per Illness in the Workplace Policy. EE encouraged to fill out V-safe. EE verbalized back understanding and denied further questions at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Chills', 'Injection site mass', 'Injection site pain', 'Malaise', 'Pain']",UNK,PFIZER\BIONTECH, 927861,VT,35.0,F,"Day 6 after receiving vaccine, slightly swollen and sore left axilla nodes. Day 8 starting to resolve",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/06/2021,6.0,PVT,Valtrex,Shingles,,,,"['Axillary pain', 'Lymphadenopathy']",1,MODERNA,IM 927862,OH,41.0,F,"Pt received vaccine at 0733 and developed itchiness, swelling and hives on face and neck. 25mg of Benadryl given at 0800. Vitals signs within defined limits sating well on RA. Pt observed for an additional 15 minutes with no other side effects noted.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,,,,,"allergies to nickel, metal, dust","['Pruritus', 'Swelling face', 'Urticaria']",1,MODERNA, 927864,MI,47.0,F,"Moderna COVID-19 Vaccine: Yesterday, 1 week post injection - bright red rash at injection site, warm to touch, feels like a hard bump at the site, whole upper arm hurts (my arm hurt for a few days after the injection, then was OK) I called my PCP's office. They stated to monitor, use Tylenol, warm compress. Seek medical visit if it gets worse. Today: I still have a rash, warm to touch, my arm doesn't hurt as bad. My mom thinks it might be spreading. She works in my PCP's office and they recommended reporting it here and monitoring.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/08/2021,9.0,PHM,Flonase Tylenol,none,"Asthma, psoriasis, rhinitis",,none,"['Injection site mass', 'Injection site rash', 'Injection site warmth', 'Pain in extremity']",UNK,MODERNA,SYR 927865,TX,66.0,F,"Sore arm, the arm where injection was dosed",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,None,None,None,,None,['Injection site pain'],UNK,MODERNA, 927866,ME,37.0,M,"The day (Dec. 24th) after Covid vaccine patient had bad headache, felt very sluggish and nauseated x3d. 4th d, patient's eyes started turning red and burning as well as a rash on face.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/24/2020,1.0,PVT,none,None,"Irritable bowel syndrome, hypothyroidism,",,Hydrocodone,"['Eye irritation', 'Headache', 'Nausea', 'Ocular hyperaemia', 'Rash', 'SARS-CoV-2 test', 'Sluggishness']",1,MODERNA, 927867,NJ,61.0,M,"Moderna 10 PM, started to shiver, head ache freezing, fever, went to sleep, had night mares, took Tylenol, sleep till 3:30 PM, went back to sleep at 6Pm and woke up 6am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,"Carvedilol 25mg , Amlodipine besylate 5 mg, Atorvastatin 10mg, Esomeprazole 40 mg, Losartan potassium 100 mg,",,High blood pressure,,,"['Chills', 'Feeling cold', 'Headache', 'Nightmare', 'Pyrexia']",UNK,MODERNA,SYR 927868,OH,44.0,F,15 post vaccination started to complain of her lips tingling. It progressed to itchy eyes and started getting a little itchy all over. Her lips went from feeling itchy to feeling waxy. Gave benadryl at 5;15 pm. Patient started felling less itchy and lips were feeling a little better at 5:30. continues to monitor patient until 5:45pm patient stated she was feeling better and felt comfortable going home. Patient left clinic at 5:50pm. Called and checked on patient at 7:00pm and she stated all symptoms were gone that she was just tired from the benadryl,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,On antibiotics for UTI started taking on 01/04/2021. Gave benadryl while on clinic for symptoms of allergic reaction,"UTI, COVID 19",,,latex,"['Eye pruritus', 'Paraesthesia oral', 'Pruritus']",1,MODERNA,IM 927869,FL,45.0,F,Patient states that she was vaccinated on 1/4/2021. She is stating that she is in pain and went to get a MRI a few days ago. The doctors told her that she has fluid in the joints from post vaccination. The doctor also mentioned to her that she needs to see an orthopedic surgeon to remove the liquid.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PUB,,,,,Mangos,"['Joint swelling', 'Pain']",1,MODERNA,IM 927870,VA,36.0,F,"On day 6 my arm begin to be sore again just like when I received the vaccine. It was sore for about 3 days. It was also red, warm, and swollen. On day 7 I noticed a rash on my arm at the injection site. It began to spread down my arm. There has also been itching too. I am now on steroids on day 2 of the pack. Rash has began lighten some and swelling and warmth has resolved still itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/04/2021,6.0,PVT,Adapalene Gel for face Spirlactone for acne Eucrisa for eczema,,Eczema (hand dermatitis),,Nickel and cobalt (showed on allergy testing September 2020),"['Erythema', 'Injection site pruritus', 'Injection site rash', 'Limb discomfort', 'Peripheral swelling', 'Skin warm']",UNK,MODERNA,IM 927871,MN,28.0,F,"About 12 hours after the shot, I had significant chills, body aches, fever, severe nausea that induced vomiting (unable to keep down water). 12 hours then after these symptoms is when things began to slowly subside. Just ended up missing work for two days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Zoloft 25 mg and Nexplanon subdermal contraceptive,None,"GERD, anxiety/depression",,None,"['Chills', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 927872,TX,35.0,F,"Sore arm, headache, neck ache, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,"Mirena IUD, sertraline",None,Anxiety and depression,Annual flu shot causes sore arm. TDaP at 34 yo also caused sore arm,Ceclor,"['Headache', 'Limb discomfort', 'Musculoskeletal discomfort', 'Nausea']",1,MODERNA,IM 927873,FL,74.0,F,"Mild swelling in throat , treated with med similar to bennidrill",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Multi vitamin Calcium D3 Saffron,None,None,,Sulfur drugs,['Pharyngeal swelling'],2,MODERNA,IM 927874,NY,36.0,F,"Patient developed erythema about a week post injection at the site, 1.5 X 2.5 inches. She was instructed to seek medical intervention in the ED",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,PVT,,,,,nitrofurantoin,"['Antibiotic therapy', 'Injection site erythema']",1,MODERNA,IM 927875,ME,63.0,M,"increase temperature 99.6-103, elevated Blood Pressure 196/128, Heart Rate 115, mild light headedness, no shortness of breath, alert and oriented",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,None,,,"10/29/2020, Influenza, FLUBLOK QUADRIVALENT",none noted,"['Blood pressure abnormal', 'Body temperature increased', 'Dizziness', 'Heart rate increased']",1,MODERNA,IM 927876,NH,78.0,F,"Injection site : Itching, large pink blotching area, hot to touch, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,OTH,"BREO ELLIPTA, incruse ellipta, albuterol hsa",,COPD,,codeine,"['Injection site pruritus', 'Injection site rash', 'Injection site warmth', 'Nausea', 'Rash macular']",1,MODERNA,IM 927877,CA,57.0,F,My arm started itching and there was a red mark on my arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,Gabapentin Benzonatate Omeprazole,None,Asthma,,Compozine Bananas Eggplant,"['Erythema', 'Pruritus']",1,MODERNA,SYR 927879,PR,53.0,F,"On Day #8 after vaccination (1st dose) of Moderna Covid-19, developed a 3 cm sore red welt hot to the touch and minor pain in the area of vaccine inoculation. I have applied 1% hydro cortisone cream and took benadryl 25mg and night and today on the morning. Area is less red and swollen but still hot to the touch. I still have fluocinonide cream that used on my nails. and fingers after an allergic episode to UV light gel nail polish and recently applied to the area to see if it helps.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,OTH,"Progesterone 400mg, Vit C, Vit B12, Caltrate, simvastatin 20mg, Cardesartan 8mg, zyrtec, Biot� hormone replacement therapy started December 14, 2020",None.,"Spondylolisthesis L5,S1, Cervical Radiculopathy C8 with numbness affecting little finger of left hand, vertigo, nasal allergies.",,No. Have had prior dermatitis related to regular use of latex gloves. Have nasal allergies and allergies to UV light gel nail polish and acrylic nails.,"['Injection site erythema', 'Urticaria', 'Vaccination site pain', 'Vaccination site swelling', 'Vaccination site warmth']",UNK,MODERNA,IM 927880,MI,42.0,F,Lightheaded and full sensation in throat 20 minutes after shot,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,PVT,Xyzal,None,Asthma,,"Food intolerances: walnuts, chickpeas, seasonal allergies","['Dizziness', 'Throat irritation']",1,PFIZER\BIONTECH,IM 927881,FL,64.0,M,vertigo,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,PVT,diabetes meds,diabetes 2,diabetes 2,,no,['Vertigo'],UNK,PFIZER\BIONTECH,IM 927883,MI,41.0,M,Bilateral rash and itchiness in palms and fingers. lasted 15-20min. Resolved with 10mg Cetirizine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,none,none,none,,none,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 927884,OH,49.0,F,"At approximately 945pm-I developed a very rapid heart rate while sitting on the couch at home. I tried to break this by bearing down, and also coughing. None of this helped. I had my husband call 911. Squad arrived-at that time my heart rate was 222 bpm. I was taken by ambulance to hospital in which i was given 6 of adenosine by IV which converted me.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,Atenolol 50mg,,"hypertension, hyperlipidemia",,"IVP dye, Robitussin","['Brain natriuretic peptide', 'Electrocardiogram', 'Full blood count', 'Heart rate increased', 'Metabolic function test', 'X-ray']",1,MODERNA,IM 927885,AZ,61.0,M,"left eye itchy on 1/4, left eye swollen on Wednesday and red, resolved on own, no treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/07/2021,3.0,PVT,,,,,,"['Eye pruritus', 'Eye swelling', 'Ocular hyperaemia']",1,PFIZER\BIONTECH,IM 927886,OH,65.0,F,"6 days post vaccine, arm felt a little itchy by the next day area was red, erythematous, slightly warm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,WRK,"Atorvastin Ca 40 mg QD, Asprin 81 mg QD, Vitamin D3 25mcg QD, Multi vitamin QD",None,Familial Lipidemia,,Latex,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 927887,NE,55.0,F,"usual right arm soreness, then settled in right wrist area tingling, pain, weakness, and itchy type feeling in wrist",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/03/2021,3.0,PVT,"Jaurdiance, Metformin, Protonix, Plavix, Mobic, Vit D3 5k, CoQ10, probiotics 25m, Losartin, Singular, Xyzal",None,"Fibromyalgia, Diabetes type 2, IBS",,"ASA, Cymbalta, Ultra, Sulfurs, Codeine, Penicillin; latex contact","['Asthenia', 'Limb discomfort', 'Pain', 'Paraesthesia', 'Pruritus']",1,PFIZER\BIONTECH,IM 927888,MD,52.0,F,"Following day (Wed) my right eye was irritated and became itchy later on. Had Dr look at it and she started me on hot compresses with orders to start eye drops with antihistamine if this did not help. Did hot compresses felt a bit better on Thurs. Fri eyes were worse, started Eye drops. Saturday ears were itchy and sore with drainage--thought infected. Sunday both eyes were red, itchy oozing,, ears still oozing and sore--went to Urgent care. They said no ear infection and started me on Eye drops with steroids but could not get them until Monday around 5pm. Corners of mouth started cracking open as well. Monday started steroid drops. Wednesday eyes were much worse and felt like glass in them. called Dr. She said to stop steroid drops and go back to antihistamine drops and start Claritin. Started immediately and I started putting Ivarest in my ears. Eyes have stopped oozing but are still red. Ears are clearing up and not as sore. Mouth is starting to clear up",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,WRK,"Furosemide, Levothyroxine 200mcg 1x per day, Chlorthalidone 25mg, 1x per day Hydrocodone-7.5-325mg (1-2 per day as needed) typically I take 1/2 twice a day probiotic",sniffles day before but thought it was from sinus,Ulcerative Colitis--not flared up Arthritis in knees and SI joint,,"allergic to Flaygyll, lisinopril, losartan, Augmentin, tetracycline","['Dry mouth', 'Ear pain', 'Ear pruritus', 'Erythema', 'Eye irrigation', 'Eye pruritus', 'Ocular hyperaemia', 'Otorrhoea']",1,MODERNA,SYR 927889,KY,42.0,F,"The evening of the vaccination I had a knot under the skin, was sore for several days but went away. 7 days after vaccine the injection site started itching really bad and the knot under my skin started getting larger. Day 9 around 8pm I noticed a large pink spot with a lighter center at the injection site 7 cm X 8 cm round/oval, slightly raised, swollen, itchy, and slightly warmer than surrounding skin. I took diphenhydramine 50 mg. I first notified my manager and reported the event to employee health nurse. The employee health nurse asked me to report the reaction to this website and contact PCP if symptoms got worse. Day 10 morning swelling and discolorization improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"levothyroxine sodium 75mcg daily, bupropion HCL XL 300mg daily, phentermine 37.5 mg daily, vitamin D2 50,000 units 1.25 mg weekly",low vitamin D level,"hypothyroid, depression/anxiety, overweight,",,Tree nut allergy,"['Injection site induration', 'Injection site mass', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 927890,DC,37.0,M,"Statement of Incident: A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020. On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured. One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable. Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with agency concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken: The Chief, Medical Staff and the Commander were notified to report the patient safety error. The team identified ten patients who did or possible did receive the invalid vaccine. After consulting with Risk Management, the Healthcare Resolution Specialist and agency, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible. Eight patients were revaccinated on 6 Jan 2021. Two declined revaccination and plan to get Dose 2 as previously scheduled. A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,MIL,,,,,,['Product storage error'],UNK,MODERNA, 927891,FL,58.0,F,Positive covid result on 1 -7-2021,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/12/2020,12/31/2020,19.0,PVT,Magnesium,,High blood pressure,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH,SYR 927892,NY,36.0,F,Moderna COVID-19 Vaccine EUA,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PUB,"Wellbutrin 150mg QD, Zoloft 50mg QD, Klonopin 0.5mg TID, Omeprazole 20mg QD, Bariatric multivitamin.",None.,None.,,"None known to any medication, food, or other products.",['Unevaluable event'],1,MODERNA,IM 927893,GA,45.0,F,red bumpy rash around the injection site--hot to touch and itches. Where the needle went in is white,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,WRK,wellbutrin lo lo estrin adderall,,narcolepsy,,floxen antibiotics,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,MODERNA,IM 927894,NY,58.0,F,"Severe itching, hotness & red at injection site - this symptom started on Day 8 following vaccine (it is now Day 9).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,"Estradiol, Calcium, Vit C, Glucosamine",None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,SYR 927895,TN,33.0,F,"Within 5 min of vaccine developed LEFT chest & neck rash / hives. Within 10 min entire neck / chest rash / hives with palpitations, tachycardia, flushing, & itching occurred. Took Benadryl 25 mg with no improvement. Monitored in ER for 2 hrs with additional dose of Benadryl 25 mg given. Rebound rash occurred about 24 hrs after injection, but no further rash / hives. Left supraclavicular lymph node swelling noted 3 days after vaccine administered. Saw PCP 01/08/2021 with persistent lymph node swelling. Starting Medrol dose pak to see if improvement occurs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Lo loestrin Fe,No,None,,TB skin test,"['Electrocardiogram', 'Flushing', 'Lymphadenopathy', 'Palpitations', 'Pruritus', 'Rash', 'Tachycardia', 'Urticaria']",1,MODERNA,IM 927896,PA,44.0,F,"Initially the recipient felt tightness in her throat, which she relates is similar to past episodes of anaphylaxis .",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,Unknown,No known illnesses at the time of vaccination,Unknown,,Shell Fish,['Throat tightness'],1,MODERNA,IM 927899,FL,55.0,F,"I experienced after taking a shower a rash, was red, blotchy down my torso and down to both of my legs which lasted a couple of hours. I talked to my HCP gave me a metrodose pack was also put on an anti histamine medication. I take quick warm showers. I called my oncologist who is recommending to see an allergist specialist and have an appointment next Tuesday. On 12-9-2020 had a swap to her nose. Yesterday after taking a hot shower, I still continue with rash on my body.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,"Xyzal PRN 5mg, Insulin pump with novalog, Spirinolactone 25mg, Ramapril 10mg, Simvastatin 40mg, Metoprolol 15mg, Levothyroxine 15mcg, Keppra 500mg, Troncandi, Vitamin D 2 1.5mg",Had right shoulder surgery on 12-09-2020.,"AML in 1992, Bone marrow transplant in 1993, Long term effects from transplant and had left carotid artery blockage, in 2018 had seizures, tremors and diagnosed with type 1 diabetes, hypothyroidism in 2016, cataract surgery in 2016, in 2010 had iron overload from blood transfusion received from treatment of her leukemia.",,"Regalan, Zonisamide, Plevto, Depatale, Tegaderm pate (upper arm and chest)","['Erythema', 'Rash', 'Rash macular']",1,MODERNA,IM 927900,IA,36.0,F,"1 week after receiving the vaccine, I developed a rash around the injection site that was warm to the tough, and was itchy. It?s been 2 days since that started and now the rash is the size of my hand.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"Escitalopram 20mg daily, vitamin d 5000 units daily, buspirone 15mg bid, multivitamin",,Obesity,,Sulfa/nauseous,"['Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,MODERNA,IM 927901,,31.0,M,"Statement of Incident: A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020. On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured. One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable. Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with MILVAX concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken: The Joint Base Medical Staff and the Medical Squadron Commander were notified to report the patient safety error. The team identified ten patients who did or possible did receive the invalid vaccine. After consulting with Risk Management, the Resolution Specialist and MILVAX, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible. Eight patients were revaccinated on 6 Jan 2021. Two declined revaccination and plan to get Dose 2 as previously scheduled. A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,MIL,,,,,,['Product storage error'],UNK,MODERNA, 927902,TX,33.0,M,tingling around eyes that resolved after 20 minutes,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,none,none,none,,unknown,['Paraesthesia'],1,MODERNA,IM 927903,MI,31.0,M,"Started with nausea, next day had joint pain, fatigue and nausea with diarrhea and fever of 101F. Day 3 had muscle pain, fatigue and severe diarrhea and fever of 100 F with acetaminophen started around the clock. Day 4 had migraine and nausea and diarrhea and fever of 100F. Day 5 has diarrhea throughout night approx every 30 minutes and extreme fatigue and headache. Symptoms have not yet subsided. One day 5 post vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,SEN,None,None,None,,None,"['Arthralgia', 'Diarrhoea', 'Fatigue', 'Headache', 'Migraine', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,IM 927904,,43.0,F,"Small red, raised area at site of injection. Warm to touch",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/05/2021,7.0,WRK,Unithroid,None,Hypothyroidism,,None,"['Injection site erythema', 'Injection site inflammation', 'Injection site warmth']",1,MODERNA,IM 927905,IN,41.0,F,I have developed a swollen/painful lymph node under my Lt armpit area.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"Birth control, Zoloft, Vit D, Prilosec",None,Anxiety,,None,"['Axillary pain', 'Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 927906,,55.0,F,"Statement of Incident: A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020. On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured. One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable. Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with Health Authority concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken: Chief, Medical Staff and the Commander were notified to report the patient safety error. The team identified ten patients who did or possible did receive the invalid vaccine. After consulting with Risk Management, the Healthcare Resolution Specialist and Health Authority, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible. Eight patients were revaccinated on 6 Jan 2021. Two declined revaccination and plan to get Dose 2 as previously scheduled. A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,MIL,,,,,,['Product storage error'],UNK,MODERNA, 927907,FL,37.0,F,2 days after vaccination client noticed lesions on right buttock. Diagnosed with Shingles 1/7/21. Rx Acyclovir by Internal Medicine MD.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PUB,TYLENOL PRN AND TRAZADONE HS,NONE,NONE,,CODEINE - HIVES,"['Herpes zoster', 'Skin lesion']",1,MODERNA,IM 927909,MI,38.0,F,"patient developed hives on heck, erythema/redness all up arms and neck, itchy on arms and feels warm behind ears. patient reports she has had many allergies (non-drug) in the past and has received allergy shots. patient received Famotidine and Prednisone in ED and discharged home",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,,,,no known drug allergies,"['Erythema', 'Multiple allergies', 'Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,IM 927910,TX,36.0,F,"Fever, chills, body aches and pain at the injection. Treatment is Tylenol. Patient will continue to monitor",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Chills', 'Injection site pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 927911,,37.0,M,"Statement of Incident: A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020. On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured. One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable. Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with program concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken: The clinic, Medical Staff and the office were notified to report the patient safety error. The team identified ten patients who did or possible did receive the invalid vaccine. After consulting with AFMRA Risk Management, the NCR Market Healthcare Resolution Specialist and program, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible. Eight patients were revaccinated on 6 Jan 2021. Two declined revaccination and plan to get Dose 2 as previously scheduled. A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented. Note: this patient was one of two who declined a second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,MIL,,,,,,['Product storage error'],UNK,MODERNA, 927912,PA,43.0,F,"Sore arm for 36hrs, followed by pain in right armpit 2-4 days post injection. 7 days after injection, developed an itchy rash at the injection site that continues to grow in size and is now 4"" x 3"" in diameter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,WRK,"B12 and B vitamin complex, Iron supplements",,,,Codeine and Acetaminophen,"['Axillary pain', 'Injection site pruritus', 'Injection site rash', 'Limb discomfort']",1,MODERNA,IM 927913,MI,48.0,F,"3pm, day after vaccine, general malaise, fatigue, body aches, no fever. Slept for 2.5 hours and woke up feeling better. Went to bed early and feel fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PUB,"Synthyroid, .75 mcg Pristiq, 50mg Supplements: Iron, Vitamin D3",Head cold 1-2 weeks prior,None,,Penicillin,"['Fatigue', 'Malaise', 'Pain']",UNK,PFIZER\BIONTECH, 927914,CT,40.0,F,"12 hours from vaccine #2, I started with rigors, myalgias/arthralgias, severe headache, temperature 100-101, nasal congestion, and profound fatigue. Symptoms resolved after 36 hours with Tylenol/Advil and supportive care. Sent for COVID Rapid PCR which was negative; missed 1 day of work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Estradiol patch,None,Endometriosis; migraines,,None,"['Arthralgia', 'Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Impaired work ability', 'Myalgia', 'Nasal congestion', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 927915,ME,42.0,F,"elevated Blood Pressure 154/104, Heart Rate 57; arm numbness/tingling, arm cold to touch",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Heart rate decreased', 'Hypertension', 'Paraesthesia', 'Peripheral coldness']",1,MODERNA,IM 927916,AZ,40.0,M,"Body aches, chills, headaches, refused MD follow up at time of report",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,SEN,,,,,,"['Chills', 'Headache', 'Pain']",1,PFIZER\BIONTECH,IM 927917,,37.0,M,"Statement of Incident: A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020. On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured. One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable. Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with Agency concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken: The contacts were notified to report the patient safety error. The team identified ten patients who did or possible did receive the invalid vaccine. After consulting with Risk Management, the Agency and Agency, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible. Eight patients were revaccinated on 6 Jan 2021. Two declined revaccination and plan to get Dose 2 as previously scheduled. A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented. Note; this was one of the two patients who chose not to get revaccinated until the scheduled second dose",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,MIL,,,,,,['Product storage error'],UNK,MODERNA, 927919,,45.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,MIL,,,,,,"['Product storage error', 'Unevaluable event']",UNK,MODERNA, 927920,IL,33.0,F,"Began feeling light headed the evening of the vaccine, overnight developed shaking chills, fever of 104 with headache. Took ibuprofen which brought temperature down to 99. Still (on day 2) having some sweats & nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Chills', 'Dizziness', 'Hyperhidrosis', 'Nausea', 'Pyrexia', 'Tremor']",2,PFIZER\BIONTECH,IM 927921,NC,36.0,M,"Shingles left flank, mild case so far",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/08/2021,17.0,PVT,N/a,Na,Na,Tetanus causes arm pain,N/a,"['Burning sensation', 'Herpes zoster', 'Rash vesicular']",1,PFIZER\BIONTECH,IM 927922,WV,22.0,F,Developed a very sore arm about 36 hours post injection. About 48 hours post injection developed swelling; redness; itching and pain at injection site. Acetaminophen used but ineffective.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,Trisprint Tech; Sertraline;,None,None,,Nickel,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Limb discomfort']",1,PFIZER\BIONTECH,IM 927923,NY,24.0,M,"Awoke at 7:30am with increased injection site soreness in upper L arm and a headache with fatigue, symptoms resolved after I took a single dose of naproxen sodium 220 mg at 2pm and currently feel no side effects",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,None,None,IBS-D,,None,"['Fatigue', 'Headache', 'Injection site discomfort']",2,PFIZER\BIONTECH,SYR 927924,CA,49.0,F,"Vertigo, diapharesis, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/04/2021,5.0,WRK,"Zyrtec, Flonase, Azestaline, MVI, vitamin C, Vit D, Albuterol prn, Tylenol. Herbal Tea Moringa & Ginger.",Sinus infection 2-3 weeks prior,"Allergy to dust mites, exercise induced Asthma not on daily meds.",,Allergy to dust mites,"['Hyperhidrosis', 'Nausea', 'Vertigo']",1,MODERNA,IM 927925,NY,39.0,F,Left side numbness and tingling on same side vaccine administered. Mild swelling to arm and hand.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,Allegra Tylenol,None,None,,None,"['Injection site hypoaesthesia', 'Injection site paraesthesia', 'Peripheral swelling']",1,PFIZER\BIONTECH,IM 927927,WV,43.0,F,"1/7/2021 Woke up at about 6am with sore arm, muscle/joint pain, low grade fever 100.4. treated with ibuprofren and tylenol 1/8/2021 Took more ibuprofren at 4am, 'feel just fine'. *I think that severity of the symptoms, which i was expecting, the 2nd dose was more 'hard hitting' then the first; More side affects with muscle and joint pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2020,01/07/2020,1.0,SEN,,,,,,"['Arthralgia', 'Myalgia', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 927928,PA,45.0,F,"Initially had localized redness, tenderness and swelling at injection site. This resolved and came back 7 days later, although with less pain and increased warmth to the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,WRK,"Plaquenil, lamictal, Wellbutrin, pristiq, vitamin D, mega red, magnesium, zinc, esomeprazole, vitamin b12, multivitamin, calcium, biotin",none,"GERD, Sjogren's, bipolar, chronic sciatica, vitamin D deficiency",,latex,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 927929,,47.0,F,"Statement of Incident: A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020. On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured. One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable. Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with agency concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken: The Medical Staff and the Medical Squadron Commander were notified to report the patient safety error. The team identified ten patients who did or possible did receive the invalid vaccine. After consulting with Risk Management, the Market Healthcare Resolution Specialist and agency, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible. Eight patients were revaccinated on 6 Jan 2021. Two declined revaccination and plan to get Dose 2 as previously scheduled. A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented. Note: this is one of the two patients who will defer a repeat dose and proceed to 2nd dose at 28 days",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,MIL,,,,,,"['Expired product administered', 'Immunisation', 'Product storage error']",UNK,MODERNA, 927930,VT,57.0,F,"Fever of 102 degrees F. or higher (temp was 102 degrees 2 hours after taking ibuprofen), shaking chills, headache, nausea, severe generalized body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Allegra,None,None,,"PCN, Compazine","['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 927931,IN,62.0,F,Swollen lymph nodes in left ancillary and into the left breast.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Allegra 180mg, levothyroxine 0.075mg,estradiol 1mg,aspirin 81mg,calcium w/vitamin D bid",,"Hypothyroidism, seasonal allergies, osteopenia",Small pox,"Biaxin, small pox vaccine",['Lymphadenopathy'],2,PFIZER\BIONTECH,IM 927933,TX,51.0,F,"patient ""did not feel right""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,none,none,none,,"naproxen, sulfa",['Feeling abnormal'],1,MODERNA,IM 927934,MI,47.0,F,"Developed fever, chills that evening, achiness, headache, arm pain through 1/7/21 evening. Was to the point of being unable to function and leave couch which is unusual for her.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,None,No. Tested positive for COVID in November,No,,None,"['Abnormal behaviour', 'Chills', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia', 'Vision blurred']",1,MODERNA,IM 927935,DC,41.0,M,"Statement of Incident: A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020. On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured. One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable. Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with Agency concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken: Agency, Medical Staff and Others were notified to report the patient safety error. The team identified ten patients who did or possible did receive the invalid vaccine. After consulting with Risk Management, the Resolution Specialist and Agency, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible. Eight patients were revaccinated on 6 Jan 2021. Two declined revaccination and plan to get Dose 2 as previously scheduled. A Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,MIL,,,,,,"['Expired product administered', 'Immunisation', 'Product storage error']",UNK,MODERNA, 927958,CT,50.0,F,"dizziness at first that lasted half hour along with heart rate increase, and slight headache. an hour after injection, body aches, lethargic, a stronger headache, injection sight (left arm) was very sore. Later, aprox 3-4 hours, as symptoms subsided (headache, body aches, lethargic, heart rate returned to normal a few hours after injection), a new symptoms arise with numbness in my left leg from the knee down to my foot ,injection sight and arm soreness, and the back of my throat felt ""funny"" and dry it lasted aprox an hour (fyi: drank plenty of water throughout these symptoms). I took my normal medication. Went to sleep. Woke up and numbness was gone. Injection sight is still a bit sore but not as intense. I am feeling well today with little or no symptoms at all.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Lexapro, Rosuvastatin, Alprazolam, Losartan, Trazodone, and pro air(prn)",,,,"Bees, spiders, strawberries","['Dizziness', 'Dry throat', 'Headache', 'Heart rate increased', 'Hypoaesthesia', 'Injection site pain', 'Lethargy', 'Pain', 'Pain in extremity', 'Throat irritation']",1,MODERNA,IM 927959,FL,62.0,F,"Itching, redness, Swelling, warmth, discomfort in left arm that started 7 days after vaccine was given. Much better now but still with smaller area of sight redness and slight itching",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,WRK,"Vitamin B12, multivitamin centrum silver, coQ10",None,None,Shingrex 08/15/2029,No known allergies,"['Erythema', 'Limb discomfort', 'Peripheral swelling', 'Pruritus', 'Skin warm']",1,MODERNA,SYR 927960,,30.0,F,"Statement of Incident: A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020. On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured. One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable. Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with agency concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken: The Medical Staff and the Medical Squadron Commander were notified to report the patient safety error. The team identified ten patients who did or possible did receive the invalid vaccine. After consulting with Risk Management, the Healthcare Resolution Specialist and agency, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible. Eight patients were revaccinated on 6 Jan 2021. Two declined revaccination and plan to get Dose 2 as previously scheduled. A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,MIL,,,,,,"['Expired product administered', 'Immunisation', 'Product storage error']",UNK,MODERNA, 927961,OH,58.0,M,"Localized reaction to injection site with swelling, redness, and tightness at site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,PVT,Levothyroxine,,Hypothroidism,,,"['Injection site erythema', 'Injection site reaction', 'Injection site swelling', 'Local reaction', 'Muscle tightness']",1,MODERNA,IM 927963,CT,28.0,M,"Erythema, itchiness and warmth around the injection site. No pain. Slight induration.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"Vitamin C daily, vitamin D weekly",Mild asthma,Mild asthma,,None.,"['Induration', 'Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 927964,WI,54.0,F,"Had my 1st Moderna COVID-19 vaccine at 0745, on 12/30/20. On 1/6/20 at approximately 0400 while taking a showering I noticed a hematoma on Left Deltoid area. During the day of 1/6/20, my Left Deltoid area became increasingly red, swollen & painful. On Thursday, 1/7/20, the Left Deltoid area continued to increase in redness, warmth & swelling. I had the area of Left Deltoid marked with a skin marker at work on 1/7/20, during the day the redness & swelling increased beyond the skin marker. After work on 1/7/20, I went to an Urgent Care, I was diagnosed with Cellulitis and prescribed antibiotics. I also was unable to go work on Friday, 1/8/20, related to pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,PVT,Gabapentin; Vit D; Vit C,None,None,,NKA,"['Cellulitis', 'Impaired work ability', 'Injection site erythema', 'Injection site haematoma', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 927965,MI,50.0,F,Insomnia for 3 nights following,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,none,none,none,,none,['Insomnia'],1,PFIZER\BIONTECH,IM 927966,GA,38.0,F,"Woke up in am day after shot with sever body aches, headache and nausea. That lasted for 24 hours. Injection site was swollen right after it was administered and red and warm to the touch for 5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,Tri-sprintec (birth control) Xyzal,None,Psoriasis Eczema,,Augmentin,"['Headache', 'Immediate post-injection reaction', 'Injection site erythema', 'Injection site swelling', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,SYR 927967,WV,43.0,F,"1/5/2021 received vaccination 1/6/2021 woke up at 6am with sore arm, muscle/joint pain, low grade fever of 100.4 . Treated with Tylenol and Ibuprofren. *I expected the second dose to be more 'hard hitting' then the first. The muscle / joint paint was a 6/10. 1/7 woke up at 4am and took Ibuprofren 1/8/ 'today i feel great'",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2020,01/07/2020,1.0,SEN,,,,,,"['Arthralgia', 'Myalgia', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 927968,NY,60.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,PVT,"Ropinirol, Omeprozole, Vitamin D",None,None,,None,['Unevaluable event'],UNK,MODERNA, 927969,WI,44.0,F,"Symptoms started 1/1/21 Pm. Headache, ear ache, chills, fever. COVID and influenza swabbed 1/5/21 both negative. Symptoms continued ear infection 1/6/21, nausea and chest pain. 1/7/21 vomiting and diarrhea started. Going in for COVID swab this am. And seeing a provider.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,"Vitamin D, Aspirin 81 mg, bupropion, metoprolol, escitalopram",Na,"Asthma, clotting disorder, SVT",,Na,"['Chest pain', 'Chills', 'Diarrhoea', 'Ear infection', 'Ear pain', 'Headache', 'Influenza virus test negative', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting']",1,PFIZER\BIONTECH,SYR 927970,,60.0,F,"Statement of Incident: A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020. On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured. One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable. Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with AGENCY concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken: Agencies were notified to report the patient safety error. The team identified ten patients who did or possible did receive the invalid vaccine. After consulting with Risk Management, the Healthcare Resolution Specialist and AGENCY, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible. Eight patients were revaccinated on 6 Jan 2021. Two declined revaccination and plan to get Dose 2 as previously scheduled. A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,MIL,,,,,,['Product storage error'],UNK,MODERNA, 927971,MT,32.0,M,Cold Flashes Migraine,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Feeling cold', 'Migraine']",1,MODERNA,IM 927972,KY,47.0,F,"On the 8th day after the vaccine I soreness in the R deltoid, arm felt warm and when I looked there was a large red area with some raised redness. My arm was also itching. Day 9 the area was larger, but had the same itching, warmth, redness and raised area, also had some hives on top of upper R shoulder. Day 10 the area was slightly smaller, still itching and tender. Taking 25mg Benadryl twice daily for the itching. This is day 10 as I turn this in.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PUB,"HCTZ, Celexa, Zinc, MVI, Oral Contraceptive",,,,PCN,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site urticaria', 'Injection site warmth', 'Pruritus']",1,MODERNA,IM 927973,OH,36.0,M,"5 minutes after receiving the Moderna COVID vaccine, patient reported numbness/tingling on the inside of his mouth and tongue. No changes in vitals. Patient given Benadryl 50 mg once. 20 minutes later, patient reported no symptoms. Monitored for an additional hour, no symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,none,,,,,"['Hypoaesthesia oral', 'Paraesthesia oral']",1,MODERNA,IM 927974,IL,46.0,F,"On day 9 developed redness, itching, swelling, hardness, heat & pain at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/07/2021,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 927975,IA,31.0,F,"Initially began with sore arm one day after vaccination (12/30), The next Wednesday (1/6), the vaccinated arm was sore, and later in the day developed small red areas near the vaccination area. The next morning the entire vaccination area was red, hot to the touch, swollen, and aching, and the redness had developed into an 11x7 cm area. The area continued to expand and later developed hives on chest, hips, legs in addition to joint pain (hips, left arm shoulder to wrist) and severe chills. Sought treatment and receive Keflex for cellulitis, since treatment the redness has improved but the area has continued to expand.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,Levothyroxine - 100 mcg daily,Recent recovery from a cold,Hypothyroidism,,Penicillin,"['Arthralgia', 'Cellulitis', 'Chills', 'Injection site erythema', 'Pain in extremity', 'Urticaria', 'Vaccination site pain', 'Vaccination site reaction', 'Vaccination site swelling', 'Vaccination site warmth']",1,MODERNA,IM 927976,PR,47.0,M,"a. Injection site tenderness which has improved in less than 24 hrs. b. chills, unquantified fever onset approximately 12 hrs after vaccine administration which improved with acetaminophen 1000mg once. Following morning, chills reappeared and improved with acetaminophen 1000mg once.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,"Micardis/Hydrochlorothiazide, Simvastatin",,"Hypertension, Hyperlipidema, Obstructive Sleep Apnea",,No history of allergies,"['Chills', 'Injection site pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 927978,TX,50.0,F,mouth tingling,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PUB,lisinopril,none,hypertension,,sulfa,['Paraesthesia oral'],1,MODERNA,IM 927979,AL,50.0,F,"sudden skin flushing from head to toe with feeling of extreme heat, feeling of doom and uneasiness that occurred within 3 minutes of injection, no tachycardia, hypertension noted, no wheezing, lungs clear, no SOB, treated with Benadryl and Pepcid with close observation for 30 minutes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,"Losartan, ASA, Synthyroid, Trazadone",none,"HTN, thyroid cancer, pemphigoid",,none,"['Anxiety', 'Feeling hot', 'Feeling of despair', 'Flushing']",1,PFIZER\BIONTECH,IM 927980,ME,53.0,F,"DAY 8 AFTER INJECTION- ITCHY, RED, SMALL WELT AT INJECTION SITE DAY 9-INCREASED SIZE OF REDNESS, WARM TO TOUCH, TENDER DAY 10- INCREASED AREA OF REDNESS, HOT TO TOUCH, MORE TENDER",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,LEVOTHYROXINE VITAMIN D APPLE CIDER VINEGAR GUMMI,NONE,NONE,,SHELLFISH,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site warmth', 'Urticaria']",1,MODERNA,IM 927981,GA,56.0,F,"Pt experiencing and c/o left nasal burning, left upper lip tingling progressing to numbness with slight swelling noted, scattered patchy hives to upper front chest, sharp HA above right eye, denies SOB, no acute respiratory distress noted or reported, slurring of words shortly after onset of other symptoms. Pt repeating ""something ain't right"". Pt received Moderna COVID vaccine at 4:35pm with no reactions or side effect noted within the post 15 and 30 minutes. EMS notified at 5:49pm. MD notifed and ordered Benadryl 50mg IM (given at 5:53pm), EpiPen and DepoMedrol 40mg IM if needed. No respiratory distess noted, pt denies SOB. EMS arrived and transported pt to ER.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,"Taking Fioricet 50-325-40 MG Tablet, Sig: 1 tablet- 2 tablets as needed for tension headache Orally Once a day Taking Escitalopram Oxalate 10 MG Tablet, Sig: 1 tablet Orally Once a day Start Date: 04/02/2020 Taking Depo-Estradiol 5 MG/M",,"N95.8 Other specified menopausal and perimenopausal disorders J30.2 Other seasonal allergic rhinitis F34.1 Dysthymia N95.1 Hot flashes due to menopause Z79.890 Postmenopausal HRT (hormone replacement therapy) G43.909 Migraine J45.901 Unspecified asthma with (acute) exacerbation J40 Bronchitis R74.8 Elevated liver enzymes R60.9 Edema J31.0 Rhinitis, unspecified type",,"MSG - ANGIODEMA, Celexa, Cipro - rash and trouble breathing, Imitrex - stops her from breathing, Amitriptyline HCl - drowsiness, Concerta, Ritalin, Tamiflu, Topamax - memory loss, Depakote - Bell's palsy, Gabapentin, Inderal LA - Lack of therapeutic, Cymbalta, sertraline - headaches","['Dysarthria', 'Headache', 'Hypoaesthesia oral', 'Lip swelling', 'Nasal discomfort', 'Paraesthesia oral', 'Repetitive speech', 'Urticaria']",1,MODERNA,IM 927983,VA,68.0,F,"Developed SOB and fatigue 1 day after vaccine, went to urgent care and tested positive for COVID at urgent care. Returned to our ED after going to urgent care again on 1/7/21, had o2 sat of 84% on room air, impoved to 98 on 3 liters. Was transferred to another facility for admission.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,celexa,none,anemia,,codeine,"[""Allen's test"", 'Base excess decreased', 'Blood bicarbonate normal', 'Blood pH normal', 'COVID-19 pneumonia', 'Computerised tomogram thorax abnormal', 'Dyspnoea', 'Fatigue', 'Lung infiltration', 'PCO2 decreased', 'PO2 normal', 'Pneumonia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 927984,MI,55.0,F,"VERY sore joint (couldn?t walk using my knees). Very exhausted, migraine headache and slight nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/18/2020,17.0,WRK,Estradiol,None,None,,None,"['Arthralgia', 'Fatigue', 'Gait inability', 'Migraine', 'Nausea']",1,PFIZER\BIONTECH,SYR 927985,NY,55.0,F,"At 330 am I got the chills and could not go back to sleep, after an hour went back to sleep around 530 am started running a fever of 100.3 and had a severe headache and body aches. Fever went down with tylenol, but had headache all day. Fever did come back later in the day resolved with Tylenol. Next day fine but did have cold sores inside mouth . Head ache on 1/8 no fever or anything.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,"Buspar, estrodial, vitamin D",no,no,,"Imetrex , Quinolones, clams","['Chills', 'Headache', 'Oral herpes', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 927986,SC,32.0,M,"Patient received his first Covid vaccine on 1/7/2021 at 12:00p. At 0000 on 1/8/2021 he started having vomiting, diarrhea, and chills. Pt had ambulance take him to ED. Pt given fluids and nausea medications and discharged home at 8:30a the same day. Pt discharged with nausea meds as well as pain meds. Covid test was collected at time of discharge.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"bp meds, cholesterol meds, anxiety meds","chronic itching being treated by doctor, chronic constipation, rectal bleeding treated by doctor","High blood pressure, high cholesterol, chronic itching",,none,"['Blood test', 'Chills', 'Diarrhoea', 'SARS-CoV-2 test', 'Vomiting']",1,MODERNA,IM 927987,MD,39.0,F,"Redness and swelling at the site of injection. The swelling was gradual and reached the size of a golf ball. It was also warm and painful to touch. The pain has receded, but there is redness and it appears the swelling has just spread out over the arm, instead of out like a golf ball.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,"vitamins, pro-biotics, Claritin, 400 mg Vitex, 1000 mg Borage oil",none,asthma,,"Erythromycin, pet dander, grass","['Injection site erythema', 'Injection site pain', 'Injection site warmth']",UNK,PFIZER\BIONTECH,SYR 927988,FL,25.0,F,"5-6 hours after vaccination, started having cramps at injection site. Vaccine given around 7:45am. Overnight, so 16-24 hours later spiking fevers to 103, severe body aches, headaches, nausea, and vomiting. Currently 26 hours out from vaccine and still having all symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Womens one a day multivitamin, Allegra, Singulair",none,none,,none,"['Headache', 'Injection site reaction', 'Muscle spasms', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 927989,WV,22.0,F,The evening of receiving the vaccine she experienced itching eyes. The next morning her rt eye was swollen and she had red spots on face and forehead. Her arm was swollen and she experienced a knot at the injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/08/2021,2.0,PVT,,,,,None reported,"['Erythema', 'Eye pruritus', 'Eye swelling', 'Injection site nodule', 'Peripheral swelling', 'Rash']",1,PFIZER\BIONTECH,IM 927990,NV,31.0,F,"1 week after vaccine I developed a small circular red rash at my injection site. In 24 hours it grew to a red circular rash approximately 5x6 inches. The rash is warm to the touch and itchy. I also developed a severe headache and chills with the rash. I was seen at the urgent care clinic for it and they suspect it might be cellulitis and prescribed me keflex. After being on keflex for one day, the rash is still growing in size. 3 other people at my workplace who received the vaccine have reported similar rashes 1 week after receiving the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,Vegetarian women?s multi vitamin with iron (brand- 365 everyday value) Pantoprazole 40mg daily Ativan .5mg daily,None,Gastric sleeve surgery in December 2019,,"Sulfa meds, grapefruit","['Chills', 'Headache', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth', 'Rash erythematous']",1,MODERNA,SYR 927991,ME,42.0,F,"After injection, area was sore to touch and did have some swelling. All of that was gone by 1/5/2021. Started to itch morning on 1/7/21 and swell again, with the central area of the swelling being hot to the touch. Still an ongoing issue at time of this report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,WRK,"lisinopril 20 mg, amlodopine 5mg, pantoprazole 20mg, cetrizine 5mg",none,high blood pressure,,"oxycodone, seasonal allergies, mold","['Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 927992,MA,24.0,F,"Day 0: Fatigue began in approximately 3 hours, felt sleepy went to sleep early Day 1: Next day, felt a bit tired til about 5pm when fatigue began to set in again. Somewhere between 5-8pm the, began to feel feverish and got a headache, mild body soreness. Required ibuprofen 200mg x1. Overnight had a fever and two episodes of sweating, chills, shaking. Felt hyperalgesia when I would wake up (normal for me with viral illness). Day 2: resolved completely by morning. Arm soreness: Day 0: not too bad Day 1: peaked around 5pm, limited ROM due to pain, swollen at site. Decreased as other symptoms increased. Day 2: still mildly sore but no need for meds or limit in ROM. Day 3: mild pain persists, no other sx",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Bupropion 300mg daily,None,Depression/Anxiety,,None,"['Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Injection site swelling', 'Mobility decreased', 'Pain', 'Pyrexia', 'Tremor']",1,MODERNA,IM 927993,KS,41.0,F,"one week after receiving injection, right arm at injection site developed redness, rash, hot to touch, painful, itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PUB,lexapro,none,none,,none,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,MODERNA,IM 927995,NE,49.0,M,Rash (hives) on my torso.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,,none,none,,pennicillin,"['Rash', 'Urticaria']",UNK,MODERNA, 927996,MA,37.0,F,Soreness in the arm where injection was hard to lift arm Fatigue Chills Body aches Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,mirena,COVID positve,none,,none,"['Chills', 'Fatigue', 'Injected limb mobility decreased', 'Injection site pain', 'Pain']",1,MODERNA,SYR 927997,MT,57.0,F,"Dry heave, headaches, muscle aches, sore injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Headache', 'Injection site pain', 'Myalgia', 'Retching']",1,MODERNA,IM 927998,NY,57.0,M,"chills, vomiting, fever, headache, body ache, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 927999,NJ,33.0,F,Low Grade Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PUB,"Prenatal vitamin, Aspirin 81mg, Vitamin B-12 2500 mcg",None,Reynaud's,,None,['Pyrexia'],1,MODERNA,IM 928000,CT,28.0,F,"Day 2: arm pain Day 8: new onset skin reaction at site of injection and below (left deltoid); swollen, red, itchy/painful, 3 quarter-sized hives",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/07/2021,10.0,SCH,"Wellbutrin, Lamictal, OCP, Prozac, Prazosin, Zyrtec, Flonase",none,depression/anxiety,,none,"['Erythema', 'Injection site reaction', 'Pain in extremity', 'Pruritus', 'Skin reaction', 'Urticaria']",1,MODERNA, 928001,GA,58.0,M,"Moderna COVID-19 Vaccine EUA Pt was diaphoretic and shaking post vaccination with the Moderna vaccine. Also became nauseous. Gave employee something to drink, monitored vitals, and had him stay in the monitoring area. Also gave employee 4mg ODT zofran for nausea. Employee's BP normalized and stated he was ok to go to work. Also stated he had never had this reaction from another vaccine and no known drug allergies.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,,,,"['Blood pressure abnormal', 'Hyperhidrosis', 'Nausea', 'Tremor']",1,MODERNA,IM 928003,TX,42.0,F,"tachycardia, palpitations, and shaky hands",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,"synthroid, claritin, tylenol",none,"hypothyroidism, anxiety",,unknown,"['Palpitations', 'Tachycardia', 'Tremor']",1,MODERNA,IM 928004,,62.0,F,"Patient 00037022 DOB 03-21-1958 received 2nd dose Pfizer lot EL1284 on 1-6-2021 in left arm. She has not had history of reaction before. Starting from midnight that night she has fever between 100.6-101.2, body aches and stiff neck. She also has swollen left arm pit, head ache, Pruritus breathing. She has a history of afib and last night she had two runs of it and took metoprolol.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Atrial fibrillation', 'Headache', 'Lymphadenopathy', 'Musculoskeletal stiffness', 'Pain', 'Pruritus', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928005,NH,38.0,F,"awoke with acute severe R flank and RLQ pain, gross hematuria, dx pyelonephritis",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,PVT,"Adderall, multivitamin",none,"constipation, ADD",,"amoxicillin, iron dextran, ketamine, demerol","['Abdominal pain lower', 'Computerised tomogram abdomen abnormal', 'Culture urine', 'Flank pain', 'Haematuria', 'Pyelonephritis', 'Renal injury']",1,MODERNA,IM 928006,KY,33.0,F,On 01/05/2021 patient noted itching at the injection site and a bumpy patch. Then on Wednesday morning she noted redness and a knot at the injection site. She has been taking ibuprofen to try to help symptoms. She did have discomfort at the site but can use her arm normally per her report.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PUB,"Losartin/HCTZ, Amlodopine, Citalopram, Vitamin D, Multivitamin, Omprazole, Loratidine, & Ibuprofen.",None.,High Blood pressure,,NKA,"['Injection site discomfort', 'Injection site erythema', 'Injection site nodule', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 928007,KS,29.0,F,6 hours post vaccine patient developed a bad headache; 12 hours post vaccine patient developed a temperature of 102 degrees tympanic; 36 hours post vaccine patient developed hives on both feet. 48 hours post vaccine patient's headache and fever were gone and mild hives remained on the feet.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Body temperature increased', 'Headache', 'Urticaria']",2,PFIZER\BIONTECH,IM 928008,FL,40.0,F,"Fatigue, confusion including disorientation and perceptual disturbances that fluctuated throughout the day. Two episodes of orthostasis and severe tinnitus lasting about 5 minutes each.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/06/2021,3.0,PUB,ZOLOFT 100MG DAILY; MELATONIN 0.5MG AT BEDTIME,ONE MONTH PRIOR HAD STEROID INJECTION BILATERALLY FOR CARPAL TUNNEL,,,CELEBREX-RASH,"['Confusional state', 'Disorientation', 'Fatigue', 'Illusion', 'Orthostatic hypotension', 'Tinnitus']",UNK,MODERNA, 928010,IN,27.0,F,"Hives, itching, burning, fatigue, chills, nausea, low grade fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,"Camerese Lo, Escitalopram",,,,No known allergies,"['Burning sensation', 'Chills', 'Fatigue', 'Nausea', 'Pruritus', 'Pyrexia', 'Urticaria']",1,MODERNA,IM 928011,FL,34.0,M,"Moderna COVID-19 Vaccine Woke up with a headache and chills around 2:30am. Tried to sleep it off. Woke up at 5:00am with 103.1 fever, nausea, headache, body aches, chills. Drank fluids and took ibuprofen, fever under control, aches subsiding. Headache lingering. Chills gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,UNK,,,,,Penicillin,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,SYR 928012,LA,50.0,F,"Patient had local reaction. Hives at site, redness on neck and face. Benadryl 25mg given po. Patient monitored about30 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,none,None,None,,None,"['Erythema', 'Injection site urticaria', 'Local reaction']",UNK,PFIZER\BIONTECH,IM 928013,NV,44.0,F,I had fever and arm was sore. I felt fatigue and very tired.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,WRK,"Sentoid, Liothyronine",None,Thyroid cancer,,None,"['Fatigue', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 928014,,28.0,M,"Muscle aches, followed by swollen lymph nodes noted in armpit of arm injected with the vaccine. Noted 2 swollen lymph nodes. Low grade fever prior to going to bed. By the morning symptoms had resolved other than swollen lymph node which remained swollen over next few days.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,UNK,,,,swollen lymph node in neck following flu vaccine several years prior,,"['Injection site swelling', 'Lymphadenopathy', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928016,WA,27.0,M,I started to feel achy all over my body. I was having chills as well. I was still able to work throughout the day 1/7/21. I've had a pain in my right arm pit that hasn't gone away. I feel a lump that is moveable and about 1 cm in diameter that is painful constantly and when I message it in my right arm pit. I feel fine otherwise 1/8/21 morning and am still going to work.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,MIL,Multivitamin Calcium Magnesium Iron,None,Chronic lower back pain,,None,"['Axillary mass', 'Axillary pain', 'Chills', 'Pain']",2,PFIZER\BIONTECH,IM 928017,VT,42.0,F,"9 days following vaccination, developed a red, warm, tender rash a little larger than the size of a sliver dollar",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,PVT,Metoprolol Succinate 50mg daily Losartan Potassium 50mg daily Tremfya 100mg injection every 8 weeks (last injection 12/17/20) Fluoxetine 20mg daily,None,"Hypertension, Psoriasis",,"Latex, bananas, walnuts","['Erythema', 'Rash', 'Skin warm', 'Tenderness']",1,MODERNA,IM 928018,TX,59.0,F,arm tingling,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,none,none,none,,sulfa,['Paraesthesia'],1,MODERNA,IM 928019,LA,30.0,F,"Patient complained of itching of tongue, mouth, and lips. Given Benadryl 50mg po, Pepcid 40mg, and Xyzal 5mg. Shortly after complained of hoarseness. No respiratory, GI or cardiovascular symptoms. ENT consulted. patient observed for 3 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Dysphonia', 'Laryngoscopy abnormal', 'Lip pruritus', 'Oral pruritus', 'Tongue pruritus']",1,PFIZER\BIONTECH,IM 928020,MI,40.0,F,"Itching was noted at the injection site five days post injection. On day seven, a raised rash/welt was noted at the site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/06/2021,6.0,PVT,none,none,asthma,,"amoxicillin, ceclor","['Injection site abscess', 'Injection site pruritus', 'Injection site rash', 'Injection site reaction', 'Rash papular', 'Urticaria']",1,MODERNA,IM 928022,MT,58.0,M,"Injection site pain, lethargic, headache, chills, muscle/joint pain, sore throat; increased severity of chronic tinnitus",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/21/2020,3.0,PVT,,,,,,"['Arthralgia', 'Chills', 'Condition aggravated', 'Headache', 'Injection site pain', 'Lethargy', 'Myalgia', 'Oropharyngeal pain', 'Tinnitus']",1,PFIZER\BIONTECH,IM 928023,OK,56.0,M,"Difficulty swallowing, macular rash on trunk and neck, pain and tightness in L shoulder, neck and ear.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Isosorbide, Synthroid, clonazepam, furosemide, albuterol MDI, tramadol, Fiorinal, Ambien, Cozaar, clonidine, aspirin, Lipitor, Plavix, nitrogylcerin tablets, tizanidine, Ranexa.","Coronary Artery Disease, Hypertension, Hyperlipidemia, Intervertebral Disk Degeneration, Peripheral Vascular Disease","Coronary Artery Disease, Hypertension, Hyperlipidemia, Intervertebral Disk Degeneration, Peripheral Vascular Disease",,None reported.,"['Dysphagia', 'Ear pain', 'Injection site pain', 'Joint stiffness', 'Neck pain', 'Rash', 'Rash macular']",1,MODERNA,IM 928024,TX,40.0,F,Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and right side facial tingling with difficulty to swallow occurred 45 minutes after receiving the vaccine. Patient took 50 mg of Benadryl after 10 minutes there was improvement and after 30 minutes it completely resolved. She woke up the next morning with HA and diarrhea she took Tylenol and will monitor.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Diarrhoea', 'Dysphagia', 'Headache', 'Odynophagia', 'Paraesthesia', 'Paraesthesia oral', 'Swollen tongue']",2,PFIZER\BIONTECH,IM 928026,IN,26.0,F,"Started with headache around 3pm the day after the vaccine administration. Took Advil around 4pm, with no relief. Nausea started shorty after eating dinner at 6pm. Around 7pm, went to bed and started getting chills and felt feverish (did not have thermometer to record temp). Napped for 3 hours and felt better after. Next morning, feeling milder headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Hydroxychloroquine 200mg BID Duloxetine 60mg qD Gabapentin 60mg qD Contrave 2 pills BID,,"Lupus, anxiety",,Sulfa drugs,"['Chills', 'Headache', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928028,IA,59.0,F,"Noticed itching of the injection site area on 1/7, the next morning it looked like a local reaction with redness, warm and sore to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,"Dexilant, Levothyroxine, Tylenol, Spirntec",None,None,,NKA,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 928029,PA,66.0,F,Started with sore throat on 1/3/2021 in afternoon by evening throat was swollen could not handle my secretions with pain 10/10. Went to the ED in the morning and was admitted with epiglottitis. No fever only low wbc count of 13.9 concerned it is a delayed reaction to vaccine,Not Reported,,Not Reported,Yes,3.0,Not Reported,N,12/20/2020,01/03/2021,14.0,PVT,"Effexor, Clonopin, Amilodpin, Protonix",none,"HTN, Barrett Esophagus, OSA",,none,"['Computerised tomogram abnormal', 'Computerised tomogram neck', 'Endoscopy abnormal', 'Epiglottitis', 'Full blood count', 'Oropharyngeal pain', 'Pharyngeal swelling', 'SARS-CoV-2 test', 'Secretion discharge', 'Streptococcus test negative', 'White blood cell count increased']",1,UNKNOWN MANUFACTURER,IM 928030,FL,70.0,M,Client verbalize tingling of the tongue and tip of fingers. Client evaluated by onsite paramedic. Client symptoms was not resolved and client was advised to seek additional evaluation but refused. Client was released at 2:10 pm accompanied by spouse.,Not Reported,,Not Reported,Not Reported,,Not Reported,,06/29/1950,01/07/2021,25760.0,PUB,None,None,GERD,,Iodine,"['Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 928031,NY,55.0,F,Shingles outbreak in mouth involving right side of hard palate and fever peaking at 101. 4 orally on 01/07/21. Began with minor itching and irritation in mouth on 01/06/2021 midmorning. Began treatment with Valacyclovir 1 gm twice a day to take for 7 days at 1:00 pm. I am using Orajel topically on the lesions and Boost nutritional supplement drink for food source currently.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/06/2021,2.0,PVT,"Precose 50 mg three times a day , Daily Multi-vitamin","Covid-19 positive on December 19, 2020. Asymptomatic and released from isolation on December 30, 2020. Passed screening questionnaire prior to Covid-19 immunization received on January 4, 2021.",Hypoglycemia,,Iodine and shellfish,"['Herpes zoster', 'Oral herpes', 'Oral pruritus', 'Pyrexia', 'Stomatitis']",1,MODERNA,IM 928032,IL,29.0,F,"12 minutes after receiving vaccine. Metallic taste in mouth, tingling in back of throat, numbness in mouth and hands. Zyrtec given. Symptoms cleared within 45 minutes of receiving Zyrtec. 4 hours post vaccine arm pain at injection site, muscle aches in other arm and joint pain in hips. Fatigue and neck rigidity. All symptoms resolved after 48 hours post vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Prenatal vitamins,N/a,N/a,,"Amoxicillin, penicillin, azithromycin, bees","['Arthralgia', 'Dysgeusia', 'Fatigue', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Injection site pain', 'Myalgia', 'Nuchal rigidity', 'Pharyngeal paraesthesia']",1,MODERNA,IM 928033,,39.0,F,Received Pfizer lot EL1284 on 1-4-2021 in left arm. On 1-5-2021 started to swollen lymph node in left arm pit.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PVT,,,,,,['Lymphadenopathy'],2,PFIZER\BIONTECH,IM 928034,,38.0,F,fever after vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,['Pyrexia'],2,PFIZER\BIONTECH,IM 928035,IN,43.0,F,"I was warm and sweaty after shot around 10am for and about hour . Then at 11:30am my arm , armpit and neck started hurting . Next every part of my body became achy at different times starting with lower back then shoulders and moved to other areas last was my inner legs . Finally I had chills ..... woke up next day feeling good but arm where I was injected hurt only",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/06/2021,5.0,PVT,No,No,No,,No,"['Axillary pain', 'Chills', 'Hyperhidrosis', 'Injection site pain', 'Neck pain', 'Pain', 'Pain in extremity', 'Skin warm']",1,MODERNA,SYR 928036,MA,28.0,F,Patient began experiencing itching at the injection site and then all over her body. She started feeling very warm and developing hives. She was given diphenhydramine 25mg by mouth. 911 was called and she was taken to the ER. The ambulance arrived about 5 minutes after 911 was called.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,SEN,Unknown,Unknown,Unknown,,"Eggplant, sulfur, penicillins, clindamycin","['Feeling hot', 'Injection site pruritus', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 928038,DE,25.0,F,"Low grade fever, extreme fatigue, nausea, and body aches. Lasted 24hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PUB,None,None,None,,None,"['Fatigue', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 928039,LA,36.0,F,"Patient had numbness, itching, tingling in left face. Given Benadryl 25mg, Pepcid 40mg po. symptoms responded rapidly. No complaints of GI, respiratory, cardiovascular symptoms. Observed almost an hour and a half.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,"hypertension, obstructive sleep apnea, prediabetes",,Iodine,"['Hypoaesthesia', 'Paraesthesia', 'Pruritus']",UNK,PFIZER\BIONTECH,IM 928040,MA,67.0,F,I had no adverse events at all until yesterday when the injection site became very slightly itchy and I rubbed it a little. This produced a red blotchy spot. Today it is twice the size of yesterday. I did apply moisturizing cream to the site yesterday morning prior to it being red.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,Atorvastatin; oxybutinin; Lisinopril; aspirin,None,"High blood pressure, controlled",,Bactrim,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Rash macular']",1,MODERNA,IM 928041,LA,28.0,F,"Patient complained of chest tighness about 20 minutes after vaccine. Benadryl 25mg given, BP 220/120. Pepcid 40mg po, Xyzal 5mg po, and tylenol 975 po given for headache. Patient given Toradol 30mg IM for continued complaints of chest tightness. patient monitored for 3 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Norvasc, HCTZ, Klonopin",none,"hypertension, obesity, Hx of COVID-19",,none,"['Chest discomfort', 'Electrocardiogram', 'Headache']",UNK,PFIZER\BIONTECH,IM 928042,PA,28.0,F,"Site of injection remained swollen for 8 days. On day 8, site become red, hot, and itchy. Area of swelling and redness increased throughout the day, about 11 cm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,UNK,none,none,none,,penicillin,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 928043,NJ,26.0,F,"Low grade fever, extreme fatigue, nausea, body aches, GI upset, all lasted approximately 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PUB,Spironolactone 100 mg BID; Cetirizine 10 mg QD; Sprintec QD;,,,,,"['Abdominal discomfort', 'Fatigue', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 928044,GA,52.0,F,Shortly after receiving the vaccination pt. complained tightening in thought area. Assessment revealed no obvious signs of edema or anaphylactic incident. Pt. administered 50mg Benadryl PO. Pt. monitored 1 hour+ with no changes in condition and no additional complaints.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,,,Unknown,,Shell Fish,['Skin tightness'],1,MODERNA,IM 928045,OH,55.0,F,"On 01/06/21, I noted itching in the area and hives. Throughout the day, the hives appeared to resolve and left a reddned area. I outlined the area with a marker and it has increased. It appears to be cellulitis; however, as I am a healthcare provider, I know that the area was thoroughly cleaned prior to injection. I am starting a dose of Keflex today (01/08/21).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,"Bystolic, metformin, lisinopril, fish oil, amtrtritpyline, simvastatin",NOne,"DM type 2, Hypertension, hypercholesterolemia",Experienced cellulitis with MMR vaccine (booster) several years ago around 2010. Have received the influenza vaccine yearly wit,"Imitrex and ""mycins""","['Cellulitis', 'Erythema', 'Pruritus', 'Urticaria']",1,MODERNA,IM 928046,TX,45.0,F,mouth tingling,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,none,none,none,,sulfa,['Paraesthesia oral'],1,MODERNA,IM 928047,MT,18.0,F,"headache, injection site pain",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Headache', 'Injection site pain']",1,PFIZER\BIONTECH,IM 928048,PA,29.0,F,"pt's arm at injection site became ithcy, red, and swollen. started on 1/6/2021, got worse on 1/7/2021, pt reports its a little bit better 1/8/2021. it is still swollen, not as itchy, not as tender to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,PVT,zoloft and a multivitamin,none,none,,no known allergies,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 928049,MN,48.0,F,"10 hours after receiving vaccination in my right arm I awoke with and experienced severe pain and inability to move arm without severe pain. Upon waking and checking into my arm further, it was noted that Bandaid looked to be placed very high on the arm. Severe pain and decreased range of motion continued for 3 days. Used ice/heat and Aleve. Right arm continues to ache at 1 week post injection but greatly improved. Presumed injected in error into shoulder joint.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/01/2021,1.0,PUB,"VItamin D3, Zinc, Multivitamin, Magnesium",None,Seasonal Allergies,,None,"['Injected limb mobility decreased', 'Pain', 'Pain in extremity', 'Product administered at inappropriate site']",1,MODERNA,UN 928050,IN,40.0,F,"Injection site and surrounding area is red, swollen, itching and warm to touch. Spoke with NP, via online portal, who stated to keep an eye on area.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,none,none,hyperlipidemia,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 928051,CO,50.0,F,"20 minutes after vaccine, cold chills sweat. 30 minutes after shortness of breath blochy rash neck/ torso. went to urgent care, wouldnt let me enter becuase didnt have a phone on to call. Went home, took 50 mg benadryl pepcid PO. took albuterol inhaler due to tachypnea. tried to wait it out at home. apporox 0200, rigors/ seizure tachypnea continued with respirations ranging 32-38/min. took 600 mg ibuprofen and albuterol inhaler, additional 50 mg benadryl. continued blocky rash. next day, called urgent care asking for appointment, thought needed steroid, they instructed to go to ED to check for covid. explained to them not covid, but allergic reaction. afraid to go to ED in thinking may need to get intubated. approx 1030 am, had 2 addtional episodes of rigors/ seizure. temp never above 99.0 F. found epi pen in house and used it. no further rigors, no further tachypnea, rash disappeared.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,estridiol 0.05 mg/day thyroxine 113 mcg/day wixella 500/50,none,asthma hypothyroid,,mushrooms cidex OPA,"['Chills', 'Cold sweat', 'Dyspnoea', 'Rash macular', 'Tachypnoea']",2,PFIZER\BIONTECH,IM 928052,,63.0,F,"Patient experienced paresthesia in the face from the eyebrow down to the chin within a few hours after the first dose of the Pfizer COVID-19 vaccine. Aside from the paresthesia under the eye that lasted approximately 48 hours, the remainder of this effect slowly improved within hours. The patient has no contributing medical conditions, chronic or short-term medication use, or drug allergies.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,,['Paraesthesia'],1,PFIZER\BIONTECH,IM 928053,MN,,M,the following morning I went to go work out and I started smelling cigarette smoke out of nowhere. Every breathe I take I smell cigarettes.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,multi Vite,no,no,,enviormental,['Parosmia'],1,PFIZER\BIONTECH,SYR 928054,NY,38.0,F,"Headache, nausea, fever, chills for approximately 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,PVT,none,none,none,,none,"['Chills', 'Headache', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,IM 928055,AZ,38.0,F,"stomach sickness , seen at hospital,",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/30/2020,2.0,PVT,,,,,,['Abdominal discomfort'],1,PFIZER\BIONTECH,IM 928056,IA,37.0,F,"On 1/8/21 notice red, warm, raised, , swollen hardened area to upper arm, around site of injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,PVT,none,none,none,,none,"['Injection site erythema', 'Injection site induration', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 928057,TX,30.0,F,"Allergic reaction, hives, wilts, itching,redness 30 min after taking benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/01/2021,9.0,PVT,Prenatal vitamins and vitamin D,,,,,"['Erythema', 'Hypersensitivity', 'Urticaria']",1,PFIZER\BIONTECH,IM 928058,AZ,47.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,['Unevaluable event'],1,PFIZER\BIONTECH,IM 928059,TX,45.0,F,mouth tingling,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,none,none,none,,sulfa,['Paraesthesia oral'],1,MODERNA,IM 928060,NY,36.0,F,"Patient returned one week after vaccination to report redness, swelling, and bruising in the left arm that was still present. NP on site examined the site and reported no infection but referred patient to call the COVID hotline.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,12/30/2020,3.0,PVT,Unknown,None reported,None reported,,None reported,"['Injection site bruising', 'Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 928061,MT,18.0,F,"headache, injection site pain",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Headache', 'Injection site pain']",1,PFIZER\BIONTECH,IM 928062,MA,85.0,M,"vomiting later on 01/05/21. Lethargy and hypoxia in pm of 01/06/21. Hypotension am of 01/07/21. Hospitalized, intubated, cardiac arrest, died 01/07/21.",Yes,01/07/2021,Not Reported,Yes,1.0,Not Reported,N,01/05/2021,01/05/2021,0.0,SEN,ACETAMINOPHEN CARBIDOPA-LEVODOPA CARBIDOPA-LEVODOPA ER CITALOPRAM HBR DONEPEZIL HCL EUCERIN FINASTERIDE FLOMAX LATANOPROST OMEPRAZOLE QUETIAPINE FUMARATE QUETIAPINE FUMARATE SENNA LAX,"Parkinson's Disease with advanced dementia, dysphagia. Alcoholism in remission. HTN. BPH. GERD","Parkinson's Disease with advanced dementia, dysphagia. Alcoholism in remission. HTN. BPH. GERD",,angioedema due to ACE and ARB meds,"['Blood lactic acid increased', 'Cardiac arrest', 'Death', 'Endotracheal intubation', 'Hypotension', 'Hypoxia', 'Laboratory test', 'Lethargy', 'Liver function test', 'Lung infiltration', 'Pancytopenia', 'Pulmonary congestion', 'Pulmonary imaging procedure abnormal', 'Troponin', 'Vomiting']",1,PFIZER\BIONTECH, 928063,IN,57.0,F,"Numbness in both legs, lasting till the next day. Fuzzy head.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,UNK,"Advil, multivitamin",No,No,,No,"['Feeling abnormal', 'Hypoaesthesia']",1,MODERNA,SYR 928064,,37.0,F,"Experienced moderate tension headache that same evening; asymptomatic the following 2 days. At 2:00 am on 1/7/21 and 1/8/21, I woke up to severe face/ears/neck/and chest itching without rash. No trouble breathing. Upon waking had small welts that resolved within an hour. Contacted PCP, continuing to monitor should symptoms persist throughout the following nights. If symptoms persist for 1 week, will schedule an appointment with PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/07/2021,3.0,PVT,No,No; however I just found out I treated a patient on 1/4/21 who tested positive for COVID on 1/7/21.,No,,No,"['Pruritus', 'Tension headache', 'Urticaria']",1,PFIZER\BIONTECH,IM 928066,IN,47.0,F,"Chills, body ache, headache, soreness under arm. injection site soreness - yesterday evening Sweats, headache, soreness under arm - this morning",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,WRK,multi vitamin (evening prior) Cranberry supplement (that morning) Vitamin C supplement (that morning) Naproxin (evening prior) Tylenol (that morning & evening prior) Hydrochlorothiazide (that morning) Cetirizine hydrochloride (evening prior,Migraine Headache,Sleep Apnea Obesity,"Flu shot, light reactions",No,"['Axillary pain', 'Chills', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Pain']",1,MODERNA,SYR 928067,IN,50.0,F,"Redness, swelling, itching at injection site Noticed the next morning, took Benadryl 1/7/21 at 9pm Still the same today 1/8/21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"Mirena, sertraline, potassium citrate, omeprazole, hydrochlorathozide",None,"High blood pressure, high cholesterol, kidney stones",,"Amoxicillin, bandaid adhesive","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 928068,NJ,56.0,F,"Very Tired around 3pm December 30th, High Blood Pressure 190/140, chills, fever 99.9 After Rest and Tylenol, started to feel better 2 days later",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,WRK,Levothyroxine 100MCG/ Letrozole 2.5MG/ Nasacort Nasal spray/ Relizen Bonafide/AREDS2 Preser Vision/Bone Strength/Vitamin D3 50MCG/Calcium 1200MG/Acid Controller,"November 10, Negative COVID test In June I did have a Positive Anti-Body Test for COVID-19",,,None aware of,"['Chills', 'Fatigue', 'Hypertension', 'Pyrexia']",UNK,MODERNA, 928069,GA,37.0,F,"Reddened area approx. 3"" in diameter, warm to touch, itchy. SOB, dizziness, intermittent nausea, intermittent diarrhea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,Nexium 40mg daily,none,none,,none,"['Diarrhoea', 'Dyspnoea', 'Erythema', 'Nausea', 'Pruritus', 'SARS-CoV-2 test negative', 'Skin warm']",1,MODERNA,IM 928071,IN,34.0,M,"Joint pain, chills, aches, neck stiffness, dizziness, fever of 100.5",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,"5,000 IU of Vitamin D once per day.",None.,None.,,None.,"['Arthralgia', 'Chills', 'Dizziness', 'Musculoskeletal stiffness', 'Pain', 'Pyrexia']",1,MODERNA,SYR 928072,KY,39.0,F,Arm pain Pain in lymph nodes Chills Headache Eye pain Back if neck pain and sore Muscle soreness entire body Nauseous Tired Pretty much felt like I had covid all over again. Per vaccine information sheets we are encouraged to report these side effects Swearing after after about Tylenol,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,Lopressor Omeprazole Claritin Vitamin d Vitamin c Zinc Trazadone Tylenol Ibuprofen,Covid positive 21 days prior to vaccine. Recovered/ No symptoms at time of vaccine. Except for some lingering fatigue when waking up on mornings.,Acid reflux Mild high. Blood pressure-normal with meds Quit smoking 21 days prior to vaccine when tested positive for covid Elevated blood sugar l,,None,"['Chills', 'Eye pain', 'Fatigue', 'Headache', 'Lymph node pain', 'Myalgia', 'Nausea', 'Neck pain', 'Pain in extremity']",1,MODERNA,IM 928075,MT,24.0,F,"Headache, Injection Site Pain",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Headache', 'Injection site pain']",1,PFIZER\BIONTECH,IM 928076,NY,46.0,F,"12/28 approximately 30 minutes after vaccine - face very red. Neck and upper chest itching. Itching resolved after about 30-40 minutes. Redness resolved after a few hours. On 1/1 , swollen lymph node in neck, painful. On 1/5 , painful lymph nodes in neck, across clavicle area to armpit. Today, 1/8, lymph nodes still swollen and painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,None,None,None,,NO known allergies,"['Arthralgia', 'Axillary pain', 'Erythema', 'Lymph node pain', 'Lymphadenopathy', 'Neck pain', 'Pruritus']",1,MODERNA,IM 928077,CT,34.0,F,Observed redness to the area of the injection site approximately 7 days after the injection. The site was warm to the touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/07/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,IM 928078,FL,28.0,F,"The day after my first vaccine, I felt overall achy and chills, this only lasted approx 6 hrs then I went to bed. The day after my second vaccine, the entire day I felt extreme arm pain, full body aches, chills and had a fever. It was hot in my room and I was wearing multiple layers of clothing and laying under my blankets, shivering. It was very uncomfortable and lasted much longer but I had heard the second vaccine was a bit more intense so I figured this was to be expected. The following morning I woke up feeling like brand new.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Birth control,None,None,,None,"['Chills', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928079,IN,27.0,F,"Day off: Arm sore One day after: Lump, arm sore, body aches, trouble breathing 2nd day to current: injection site lump is sore and itches, trouble breathing, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Sertraline 100 mg,No,None,,"Avocado, broccoli","['Dyspnoea', 'Injection site mass', 'Pain', 'Pain in extremity', 'Pruritus']",1,PFIZER\BIONTECH,SYR 928080,FL,42.0,F,"Headache, Fatigue, Body Aches, Lightheaded onset day after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,"Protonix,Saxenda,Abilify,Wellbutrin,Adderall,Singular,Zyrtec,Advil,Ambien,Tamazepam",,"Migraine,Asthma,Bipolar",,"Morphine,Codeine,Hydrocodone,DHE","['Dizziness', 'Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 928081,MI,57.0,F,Patient experienced lower lip swelling and tingling. Patient given 12.5 mg of Benadryl and monitored for 30 minutes. Symptoms resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"levothyroxine, simvastatin",,"hypothyroid, HLD",,fish,"['Lip swelling', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 928082,NY,63.0,F,Large hive hot sore at injection site. Approximately 5 inches one week AFTER injection,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"trazadone, amitza, prozac",none,none,,seasonal allergies,"['Injection site pain', 'Injection site urticaria', 'Injection site warmth']",1,MODERNA,IM 928083,TX,41.0,F,Temperature at 6:00 am of 100.6 Temperature at 6:30 am of 100.7 Temperature at 8: 15 am 99.6 nausea for a brief period of time headache ongoing,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PUB,"ibuprofen, zyrtec,","headache off and on not constant, runny nose at times",none,,none,"['Body temperature increased', 'Gaze palsy', 'Nausea']",UNK,MODERNA,IM 928085,FL,70.0,M,Client verbalize tingling of the tongue and tip of fingers. Client evaluated by onsite paramedic. Client symptoms was not resolved and client ws advised to seek additional evaluation but refused . Client was released at 2:10 pm accompanied by spouse.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,None,None,GERD,,Iodine,"['Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH, 928086,MN,34.0,F,The next day after shot I developed an induration of site and it became very itchy for 24 hours. Red welt stayed in place about half dollar size for 2 days then went away. Then a week later same symptoms developed. And left a bruise from welt and itching. Lasted 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,PVT,Multi-vitamin,None,None,,No,"['Injection site bruising', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 928087,NY,48.0,F,"within an hour of getting the vaccine, I started with a headache. After about 2 hrs I was dizzy, tingling down my left arm, stiffness in left arm and neck. I was given the vaccine around 230 pm. By late evening I was lethargic. today is Friday I continue to have the same symptoms but also to include, nausea, vomiting, body aches, chills, congestion, and shortness of breath, I have occasionally felt a heart arrhythmia.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,"milk thistle, lemon balm, mullein, lavender, black seed oil, turmeric, Fd guard, papaya enzymes, chlorella multivitamin, calcium/magnesium/zinc, omega3/vitamin d,","lyme arthritis, celiac, IBS","celiac, pancreas divisum, chronic lyme disease, mycoplasma, IBS, fibromyalgia, bartonella, encephalitis, inflammatory disease, stroke",,"penicillin, gadolinium, gluten","['Chills', 'Dizziness', 'Dyspnoea', 'Headache', 'Lethargy', 'Musculoskeletal stiffness', 'Nausea', 'Pain', 'Paraesthesia', 'Respiratory tract congestion', 'Vomiting']",1,MODERNA,IM 928088,CO,31.0,F,"within 5 minutes of the vaccine administration patient had numbness/tingling of her lips, tongue, and face. She was given Benadryl, which she states improved her symptoms and she was able to sleep. This morning (day after vaccine) she states that her tingling feeling has returned to her face, lips and tongue and she feels a globus sensation and constriction within her throat. She has taken a benadryl this morning with no improvement. Patient was recommended to seek care in the ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"mulitvitamin, fexofenadine, biotin-silicon diox-L-cystine",none known,"hypothyroidism, GERD, palpitations",,"penicillins, ambien, gluten, lactose","['Hypoaesthesia oral', 'Paraesthesia oral', 'Sensation of foreign body', 'Throat tightness']",1,PFIZER\BIONTECH,IM 928090,TX,30.0,F,"Allergic reaction: hives, wilts, redness, itchiness, abdominal pain Treated with Benadryl and went away in 30 min or so",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/01/2021,9.0,PVT,"Vitamin D, prenatal vitamin",None,None,,None,"['Abdominal pain', 'Hypersensitivity', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,SYR 928091,GA,44.0,F,"Moderna COVID-19 Vaccine EUA We had at least 7 different patients all receive their Moderna vaccine on the same day complain of the same thing 7-8 days later. They all had delayed injection site reaction, swollen arm, and warm to touch. All advised to use a warm compress and take antihistamines or tylenol/ibuprofen as needed. This appears to be quite a common response. I want to report it but not submitting all 7 patients separately. As far as I know, they have all resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,PVT,,,,,,"['Peripheral swelling', 'Skin warm']",1,MODERNA,IM 928092,IN,36.0,M,"Chills, body aches, tiredness and fever. Rest, fluids and tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,None,None,,Penicillin,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",1,MODERNA,IM 928093,MI,32.0,F,Pfizer-BioNTech COVID-19 Vaccine EUA At 10pm on January 6th she started having chills and a headache. She than started with a fever and body aches. Fever 100.5 on 1/7/21 after Tylenol. Symptoms are still persisting. temp was 99.5 this morning 1 hour after taking Tylenol.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Prozac and omeprazole,COVID + December 18th,Asthma -well controlled. No medications,,Vicodin-Nausea,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 928094,WI,49.0,F,"Nausea, Headache, Fever, Sweats, Sore Arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Potassium, Lexapro, Flonase, Pantoprazole, Chlorthalidone, Pepcid",None,"Fibromyalgia, HTN, History of breast cancer",,"Aspirin, Bee stings, Bee Venom","['Headache', 'Hyperhidrosis', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 928095,MT,33.0,F,"difficulty breathing, light headedness, burning on the left side of chest/was seen in the ER, symptoms subsided",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Chest pain', 'Dizziness', 'Dyspnoea']",1,PFIZER\BIONTECH,IM 928096,OH,55.0,F,"Woke up at 0300 next morning and got up to bathroom. Ended up getting dizzy, passing out and dislocating shoulder. Husband found her on floor. As day continued, still was shaky, nauseated, lightheaded and had headache. Finally passed by Thursday evening.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Hydrochlorothiazide daily Potassium twice daily Gabapentin twice daily,No Was really sick in March and thinks was COVID but was never tested,Complex regional pain syndrome left foot post-op,"had shingles vaccine 3 weeks prior to COVID vaccination and had all listed side effects. Otherwise, no",No,"['Dizziness', 'Headache', 'Loss of consciousness', 'Nausea', 'Tremor']",1,MODERNA,IM 928097,PA,43.0,F,"Tuesday night, hot to touch area where it was given, lump, sore until Wednesday like the flu shot, 2 inch red circle around injection site, solid red circle, lump is not visible to the eye but there when touching, placed warm compress on it Wednesday and ice Wednesday afternoon, as of today it is not as sore or hot but is still warm to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PUB,"Adderall xr, gabapentin, metformin, Prozac, atenolol, protonic, trazadone, singulair, carbamazetine, vitamin iron, vitamin d,",,"adhd, Gerd, Potts, asthma, restless leg syndrome , left leg muscle spasm, depression, anxiety, seasonal allergies, ovarian cyst",,"pcn, erythromycin, amoxicillin,","['Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 928099,NY,30.0,F,Mild chills - onset 8-12 hours after Body aches - onset 8-12 hours after Fatigue - onset 8-12 hours after,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,Nexplanon implant Magnesium Vitamin B12 Vitamin D3 Riboflavin Biotin Vitamin C,None,Migraine headaches,,Nickel,"['Chills', 'Fatigue', 'Pain']",2,PFIZER\BIONTECH,IM 928100,IN,30.0,M,"GI upset ? 10pm 1/6 to 12pm 1/7 Headache, chills, myalgias? 8am 1/7 to 8am 1/8",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,No,No,,None,"['Abdominal discomfort', 'Chills', 'Headache', 'Myalgia']",UNK,MODERNA,SYR 928101,AZ,56.0,F,"Fever, congestion, breathing issues, headache, backache",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,"Trazadone, Thyroid meds- Synthroid and Liothyrine , Rovastatin, Zoloft",No,No,,"Penicillin, Laytex","['Back pain', 'Dyspnoea', 'Headache', 'Pyrexia', 'Respiratory tract congestion']",UNK,MODERNA,IM 928102,OH,36.0,F,"Chills, fever 104.4, nausea, headache, body ache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Tylenol, vit c and zinc",Na,Na,,Nka,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",UNK,MODERNA, 928103,TX,31.0,F,"Once I got home from work I started feeling nauseous, throbbing headache, soreness in my arm with a welt on the injection site. Around 11pm I started vomiting violently through the entire night with sweats and chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Chills', 'Headache', 'Hyperhidrosis', 'Injection site reaction', 'Nausea', 'Pain in extremity', 'Urticaria', 'Vomiting']",1,MODERNA,SYR 928104,CO,50.0,F,"approx 20 after injection 1420, started getting chills, cold sweat, elevated heart rate, shortness of breath and blocky red rash on neck and torso. immediately drove to urgent care, was not allowed in for treatment due to did not have phone on med to call for appointment. went home, took 50 mg benadryl and pepcid po. had tachypnea and continued blocky rash on neck and torso with chest tightness. took albuterol inhaler. approx 0200 had rigors/ seizure. with continued prior symptoms. took additional 50 mg benadryl and albuterol inhaler. temp 99.0. in am 1/6 called urgent care to make appointment thought neded steroid. they said to go to ED. was afraid to go to ED in fear would be intubated as had before for allergic reaction. took additonal 50 mg benadryl, pepcid and zyrtec along with a shot of epi pen. within minutes, all symptoms ressolved. will be calling place where I got vaccinated today to report. 1/8/21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,estridole 0.05 mg patch levothyroxine 113 mcg wixella 500/50 inhaler,none,asthma hypothyroid,,mushrooms Cidex OPA,"['Chest discomfort', 'Chills', 'Cold sweat', 'Dyspnoea', 'Heart rate increased', 'Rash', 'Rash erythematous', 'Seizure', 'Tachypnoea']",1,UNKNOWN MANUFACTURER, 928105,,27.0,F,"Hives, Redness, itchy, leg tremors, nervous 25 mg Benadryl PO administered",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Erythema', 'Nervousness', 'Pruritus', 'Tremor', 'Urticaria']",2,PFIZER\BIONTECH,IM 928106,,36.0,F,"Pfizer-BioNTech COVID-19Vaccine EUA I received my shot on 01/06/2021 at 0830 a few minutes after receiving the vaccine I became dizzy and lightheaded. I let the nurse in the observation area know and honestly didn't think much of it. It lasted about a minute or two. I was fine for several hours after just experienced the normal soreness and kind of achy tired feeling. Around 1700 I began to itch, my whole right arm and upper torso area was itchy. I did not take any medications for this and it subsided around 2000.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,Allegra Multivitamin 81 mg ASA,,polycythemia vera (genetic) seasonal allergies,,"Gluten, PNC and ceclor","['Dizziness', 'Fatigue', 'Pain', 'Pruritus']",1,PFIZER\BIONTECH,IM 928108,GA,25.0,F,"12/23 VACCINATION 12/24 WOKE UP TO ARM PAIN, FATIGUE, CHILLS, MUSCLE ACHES. TEMP IN AFTERNOON OF 101.0 TOOK TYLENOL; 99.5. TEMPERATURE PERSISTED 3-4 DAYS BETWEEN 100-102. TREATED WITH TYLENOL.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PUB,,,,"FLU; 24 HOURS OF CHILLS, FATIGUE","CELEBREX, TREE NUTS","['Body temperature increased', 'Chills', 'Fatigue', 'Myalgia', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 928109,RI,48.0,F,Not feeling well,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,UNK,Unknown Jardiance 25 mg tablet Unknown Metformin Hydrochloride 500 tablet Unknown ONE TOUCH DELICA LANCETS Unknown ONE TOUCH VERIO TEST STRIPS apply one drop of blood to test strip Unknown Tylenol 325 mg capsule Unknown ven,N.A,"Z98.890 Status post breast lumpectomy I10 Primary hypertension F33.41 MDD (major depressive disorder), recurrent, in partial remission Z85.3 History of malignant neoplasm of right breast N92.6 Missed periods G47.33 Obstructive sleep apnea (adult) (pediatric) F41.1 GAD (generalized anxiety disorder) F90.0 ADHD (attention deficit hyperactivity disorder), inattentive type Z87.891 Former smoker R53.82 Chronic fatigue N95.1 Perimenopausal symptoms K76.0 Hepatic steatosis K21.9 Gastroesophageal reflux disease, esophagitis presence not specified E11.65 Uncontrolled type 2 diabetes mellitus with hyperglycemia PHDMP Diabetes Management Program G25.81 Restless leg syndrome G47.8 Sleep paralysis E11.9 Type 2 diabetes mellitus without complication, without long-term current use of insulin",,N.K.D.A.,['Malaise'],UNK,MODERNA, 928111,GA,47.0,F,"Day of shot soreness in left deltoid that ran from shot site to inner arm started about four hours after shot and lasted 24-72 hours. No redness at that time. Pain went away then returned Day 8. Day 8, today January 8th, woke up to pain again in left arm starting at injection site running to inner arm. Redness is mild at site of injection, as it runs to inner arm gets redder and then ends with a warm, red, swollen lump. Lump is not in lymph node, it is on inner side of left arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,PVT,Tylenol,No,None,,"Talwin, Celebrex, Enviromental allergies","['Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 928112,TN,41.0,F,"Red, itchy bumps on several places throughout the body.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,WRK,"Triamterene, Wellbutrin, Metoprolol, Omeprazole, Vitamin D, Magnesium, Potassium, Melatonin",None,"Fibromyalgia, Minears Disease",,Shellfish,"['Rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 928113,IN,25.0,F,"severe arm pain, dizziness (spins) anytime I woke in the middle of the night starting at 12am on 01/01/2020, when trying to get out of bed at 0800 on 01/01/2020 I continued to have severe dizziness to the point I couldn't walk, vomitting, in ability to keep anything down by mouth, muscle pain, severe arm pain in arm vaccine was given. At 2pm I was still having moderate dizziness, nausea, and began to have a headache. For a week I continued to have mild dizziness, headache, extreme fatigue, brain fog, and swollen lymph node pain in the armpit of the arm I received the vaccine in (right side). I continue to have mild brain fog and headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,WRK,Prenatal vitamin and 6400u vitamin D,,,,"sulfa, errythromycin , latex, adhesive","['Dizziness', 'Fatigue', 'Feeling abnormal', 'Headache', 'Mobility decreased', 'Myalgia', 'Nausea', 'Pain in extremity', 'Vomiting']",1,PFIZER\BIONTECH,IM 928114,VT,56.0,F,"35 minutes After vaccination.... complaints of chest tightness, ""funny"" tongue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,WRK,,,,,,"['Chest discomfort', 'Tongue discomfort']",1,PFIZER\BIONTECH,IM 928115,TX,68.0,M,"Moderna COVID-19 Vaccine Day 1 after injection, malaise, fatigue, dizziness. Day 2 after injection, major nausea with significant bouts of vomiting lasting approximately 12 hours. when that resolved, severe and recurrent diahrea for another 8 hours. I will decline the 2nd dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,"Xarelto, Lipitor, Coreg, Lasix",None,None,,No,"['Diarrhoea', 'Dizziness', 'Fatigue', 'Malaise', 'Nausea', 'Vomiting']",1,MODERNA,IM 928116,FL,52.0,F,Patient developed pale pink erythema and swelling below vaccination site. Given Keflex and prednisone,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,PUB,Synthroid vitamin d,None,hypothyroidism,,None,"['Erythema', 'Swelling']",UNK,MODERNA, 928117,MT,54.0,F,"body aches, vomitting for 12 hrs, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Nausea', 'Pain', 'Vomiting']",1,PFIZER\BIONTECH,IM 928118,KS,41.0,F,"7 days after vaccine, right arm at injection site area became red, swollen, hot to touch, developed hives, and itched.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PUB,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria', 'Injection site warmth']",1,MODERNA,IM 928120,CA,56.0,M,body ache arm sore chest pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,UNK,none,none,none,,none,"['Chest pain', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 928121,IN,48.0,F,Rt side of my face was numb for about an hour,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Nexium OTC Munti Vitamins OTC Iron OTC Culturell Complex B,,GERD,,Contrast Dye,['Hypoaesthesia'],1,MODERNA,IM 928122,NY,61.0,F,"Moderna COVID-19 Vaccine EUA Began with headache, flushed face then sore arm about 6 hours after injection. Within 2 hours after I had severe chills, worsening headache with severe light sensitivity and nausea, severe heartburn, severe muscle aches, fever of 102.8, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,"Vitamin A, C, D, B-12, multi vitamin, probiotic, biotin",None,None,,"seasonal allergies - dust, pollen, mites, trees, grasses","['Chills', 'Dyspepsia', 'Fatigue', 'Flushing', 'Headache', 'Impaired work ability', 'Myalgia', 'Nausea', 'Pain in extremity', 'Photophobia', 'Pyrexia']",1,MODERNA,SYR 928123,VA,32.0,M,"employee reported fever and chills beginning 3:30am. He treated w/ Tylenol, no effect and then later took Ibuprofen. At 11:50 am on 1/7 his temp was down to 99.7.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Chills', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928124,GA,44.0,F,"Moderna COVID-19 Vaccine EUA We had a minimum of 7 reports (likely more) of patients receiving the Moderna vaccine and having injection site reaction starting 7-8 days later. Each complained of the area being swollen and warm to touch and red. All advised to monitor the area, use a warm compress, and use supportive care like benadryl, ibuprofen, and tylenol as needed. As far as we know all resolved. Appears to be a very common reaction to this particular vaccine. I will not be reporting them individually but noted many reports after the first dose in the series.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,PVT,,,,,,"['Injection site reaction', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 928126,IN,33.0,F,Headache and fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"Phenergan, Pristiq",,"Crohns Disease, chronic migraine, fibromyalgia",,"NSAIDs, amitryptaline","['Fatigue', 'Headache']",1,MODERNA, 928127,AZ,47.0,F,"Throat flem, body tingles, EMS screened, increased observation time, resloved in 15 min",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Paraesthesia', 'Productive cough']",1,PFIZER\BIONTECH,IM 928128,MI,34.0,M,"headache, achy all over, bruising to under arm, increased fatigue, poor endurance. the morning after is when symptoms started",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,SEN,0,0,0,,0,"['Asthenia', 'Contusion', 'Fatigue', 'Headache', 'Pain']",1,MODERNA,IM 928130,OH,40.0,M,Full vaccine not administered. Small amount leaked from injection site- received about 85% of dose,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None reported,None reported,None reported,,None reported,"['Exposure via skin contact', 'Injection site extravasation', 'Underdose']",1,MODERNA,IM 928133,KS,68.0,F,"She got lump in throat, hives in mouth, no cardiopulmonary sx. We gave her epi",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Sensation of foreign body', 'Urticaria']",1,MODERNA,IM 928135,NY,49.0,F,"Localized reaction starting 6 days post injection the area about the size of a tennis ball became red, swollen, hard, hot with minimal pain and itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/04/2021,6.0,PVT,none,none,none,,keflex seldane tincture of benzoin,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Local reaction']",1,MODERNA,IM 928136,CT,48.0,M,"Chills, Muscle Aches, Fever 101",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"Lipitor, ASA, Zyrtec",,Heart Disease,,Seasonal,"['Chills', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928137,MA,60.0,F,"On day 10 after the vaccine, 1/7/2021, a rash developed at the injection site. Initially a red circle about the size of a nickel. Has now spread to about a 2-3 inch area of pink/redness. Occasional itchiness. Slight warmth to the touch. No pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/07/2021,10.0,PVT,"Omeprazole, Citalopram, Loratadine",None,None,,Allergic to PCN,"['Injection site rash', 'Injection site warmth', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 928139,AL,37.0,M,"Rash, initial presentation bilateral anterior thighs. Painful to touch. Pain in soles of feet. Joint pain, left knee. 1/7/21 Spread of rash to posterior hands and anterior fingers. 1/8/21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,PVT,"One-a-day multivitamin, fish oil, magnesium, vit D3, sildenafil 60mg PRN",None,"Hypertension, Obstructive Sleep Apnea, ED",,Ceclor - hives,"['Arthralgia', 'Pain in extremity', 'Rash', 'Tenderness']",1,MODERNA,IM 928140,MT,44.0,F,"fever, neck stiffness, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Headache', 'Musculoskeletal stiffness', 'Pyrexia']",1,PFIZER\BIONTECH,IM 928142,IN,37.0,F,"Soreness and aching to left arm approximately 3hrs after vaccine. Nausea with dry heaves, body aches, sweats, extreme fatigue, and headache by 7:00 am the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,Lexapro 20 MG once daily,Covid 19 positive on 12-26-20,None,,,"['Fatigue', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pain', 'Pain in extremity', 'Retching']",UNK,PFIZER\BIONTECH,SYR 928143,WI,34.0,F,"January 06, 2021 ?11:50am shot received Right arm ?21:00 right neck pain ?22:00 right ear pain ?22:24 right headache and neck pain January 07, 2021 ?07:00 sore throat ?07:00 fatigue, extreme January 8, 2021 ?07:00 fatigue still extreme",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Dupilomab; albuterol; atrovent; duo neb; albuterol neb; trazodone; hydroxyzine; lamictal; pregabalin,Asthma; endometriosis; sleep apnea; anxiety; mood disorder,Asthma; endometriosis; anxiety;,,Bee venom,"['Ear pain', 'Fatigue', 'Headache', 'Neck pain', 'Oropharyngeal pain']",1,PFIZER\BIONTECH,SYR 928144,AZ,37.0,M,"FELT FLUSED FEELING, LEFT ARM /LEFT HAND TINGLING - LEFT FACILITY AFTER VITAL SIGNS TAKEN BY EMS ON SCENE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Flushing', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 928145,GA,35.0,F,"sore arm with raised, warm, red, itchy bump at injection site measuring 1in wide by 2in long lasting 10 days (site still discolored on 11th day). No treatment. Chest tightness, difficulty breathing, asthmatic cough starting a few hours after injection and lasting 4 days. Used albuterol rescue inhaler four times a day (2 puffs each time) for all 4 days. Extreme fatigue and inability to stay awake the day of injection and the day after. No treatment other than sleeping more.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"clarinex, simbicort, singulair, rhinocort spray, nortryptaline, orthotricyclen lo",none,"asthma, endometriosis, chronic migraines",,ibuprofen,"['Chest discomfort', 'Cough variant asthma', 'Dyspnoea', 'Fatigue', 'Hypersomnia', 'Injection site discolouration', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Somnolence']",1,MODERNA,IM 928146,FL,48.0,F,"I started feeling achy (body aches) at night and took Tylenol and the next day at work I started having abd pain, joint pain and headache, and at home I checked my temp and it was 100.8F and my heart rate was fast, my lungs felt tight and a Tylenol and the symptoms continued for another day and gradually went away with exception of my joint pains. I also had tingling on my arms, back of my head, legs and my neck. I went to a neurologist and an allergist . My PCP does not want to make a decision about whether or not I should have the second dose before I see those.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,01/21/2021,31.0,PVT,"Vitamin D (400ou daily), as needed inhaler",No,"mild asthma, environmental allergies",for the 1st time ever I had itching after receiving my flu shot that I received 09/2020 - got it at pharmacy (multidose vial),sulfa,"['Abdominal pain', 'Arthralgia', 'Body temperature increased', 'Headache', 'Heart rate increased', 'Pain', 'Paraesthesia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,SYR 928147,NE,47.0,F,"Warm to touch upper left deltoid, large size swollen knot that is red on upper left deltoid, it seems to be getting larger. first noticed on 01/06/21 about 4:30 pm and as of today 1/08/21 the area is still swollen, red and warm to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,,,Na,,"Peanuts, Walnuts and all tree nuts","['Injection site erythema', 'Injection site mass', 'Injection site swelling', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 928148,MA,37.0,F,Severe localized reaction. Inflammation from Axcillary to fingers. Severe pain causing difficulty moving arm and completing ADLs. Swelling and hot lump on arm. Seen by doctor for reaction,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,Atorvastatin,,,Cellulitis from flu vaccine 2010,Dilaudid,"['Inflammation', 'Limb mass', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Pain in extremity', 'Peripheral swelling', 'Skin reaction', 'Skin warm']",1,MODERNA,IM 928150,MI,32.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA on January 6th at 10:00pm individual started having chills. She then started having a headache, fever, and body aches. Temp yesterday was above 101 with the use of Tylenol. Today her symptoms are persisting and temp was 99.5 1 hour after Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Prozac and omperazole,COVID+ December 18th,Ashtma-well controlled. No medications,,Vicodin-Nausea,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 928151,PA,52.0,F,"Developed shortness of breath 10 minutes after receiving vaccine. also developed hoarseness, elevated blood pressure, red rash (not hives) on neck and left deltoid area. Was taken to Emergency Room by ambulance.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Premedicated for three days prior to vaccine with Advair inhaler BID. Albuterol inhaler prn.,COVID long hauler.,COVID long hauler with asthma since COVID illness in March 2020.,"FluMist - chest tightness, tingling lips, difficulty swallowing.","tree fruit, latex.","['Blood pressure increased', 'Dysphonia', 'Dyspnoea', 'Injection site rash', 'Rash', 'Rash erythematous']",1,MODERNA,IM 928152,OH,44.0,F,"Redness and soreness noted day after, then 1 week later severe redness, soreness, and slight swelling at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,PVT,Birth Control Pill,none,none,,NKDA,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 928153,IN,33.0,M,Onset lethargy feeling ?down? and drained of energy and ?foggy?,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,UNK,None,None,Obesity,,None,"['Asthenia', 'Depressed mood', 'Feeling abnormal', 'Lethargy']",1,PFIZER\BIONTECH,IM 928155,AR,41.0,F,"Upon waking in am on 1/7/21 noted rash had developed on chest and neck. Experienced extreme pain length of spine as well as in left arm. Pain to excruciating to stand, walk or sit. Was physically able to move legs but anything that required movement felt extreme pain in spine. Went to physicians office on 1/7/21, Prednisone was ordered. Blood work done which revealed elevated liver enzymes, will return to physician's office on 1/11/21 for repeat labs. Rash on chest and neck is better on 1/8/21 however remains blotchy. All treatment orders were Prednisone, lab work, Tylenol, and heating pad. Return to physician on 1/11/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,"COVID-19 Infection, diagnosed on 12/11/20, recovered 12/21/20.",,,,"['Blood test abnormal', 'Dysstasia', 'Gait disturbance', 'Hepatic enzyme increased', 'Mobility decreased', 'Pain', 'Pain in extremity', 'Rash', 'Rash macular', 'Spinal pain']",2,MODERNA,IM 928156,NC,41.0,F,"Lethargy onset approximately 4 hours after dose. SOB while supine. 1 day later continued lethargy and orthopnea, plus imms site soreness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,MIL,,,,,Coconut (anaphylaxis),"['Chest X-ray normal', 'Dyspnoea', 'Electrocardiogram normal', 'Injection site pain', 'Lethargy', 'Orthopnoea']",2,PFIZER\BIONTECH,IM 928157,CA,57.0,M,Severe lower back pain mimicking kidney infection/stone pain at belt line. Unable to walk/breathe/sit or turn.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/18/2020,1.0,PVT,OxyContin 325/10,Fibromyalgia,"Fibromyalgia, chronic back pain.",,"Fentanyl, azithromyecin","['Back pain', 'Blood test', 'Computerised tomogram abdomen', 'Computerised tomogram pelvis', 'Urine analysis']",1,PFIZER\BIONTECH,SYR 928158,MA,34.0,F,11 days after vaccine hive rash just below site of injection of moderna vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/07/2021,11.0,PVT,Clobetasol,,Eczema,,,"['Injection site rash', 'Injection site urticaria']",1,MODERNA, 928159,IA,27.0,F,"Fever started on 1/7 at around 7:00am, highest was 100.2, Took tylenol Nausea, headache, body aches as well",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,tylenol,none,none,,none,"['Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 928161,PA,63.0,F,"Redness, warmth, swelling and pain post injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/08/2021,9.0,PVT,,,,,,"['Erythema', 'Pain', 'Skin warm', 'Swelling']",1,MODERNA,IM 928162,,54.0,F,"Patient received vaccine on Wednesday. Then Thursday at 11 am she stated she started to feel achy, nauseated and feverish. At about noon patient vomited. She took 2 Motrin at about 1 pm, slept the afternoon, took more Motrin at 7 pm, went back to bed later that night and by Friday morning felt fine. Her injection site is red, warm to touch, tender, and a firm area felt.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site warmth', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 928163,MT,50.0,F,"inject site soreness, dizziness, headache, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Chills', 'Dizziness', 'Headache', 'Injection site pain']",1,PFIZER\BIONTECH,IM 928164,IN,54.0,F,Sore arm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,None,High blood pressure,,Shell fish,['Pain in extremity'],UNK,MODERNA,SYR 928165,MI,29.0,F,"Swollen lymph nodes with pfzier covid vaccine, resolved in ~12-18 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,WRK,"Iron, claritin, flonase, Balziva birth control, olly multivitamin",allergies/sinuses,allergies/sinuses,,"bactrim - tongue swelling, SOB azithromycin - hives on calf as child",['Lymphadenopathy'],UNK,PFIZER\BIONTECH, 928167,NC,61.0,F,"Headache, fever, joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PUB,"Vitamin D, C and Magnesium",None,None,,None,"['Arthralgia', 'Headache', 'Pyrexia']",1,MODERNA,IM 928168,TX,,F,3 days after shot My mother has tenderness and redness the size of a cookie at the Injection site possibly warm to touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/08/2021,3.0,PVT,"metformin, anastrazole, atovastatin, meloxicam",COVID - 12/1/2020,"Diabetes, osteoarthritis, breast cancer 5 years ago",,no,"['Injection site erythema', 'Injection site pain']",UNK,MODERNA,SYR 928169,UT,23.0,F,"vitals, observation, water",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,Gabapentin 300 mg cap- migraine headache,Pt denies,migraine headaches,,Lortab Reglan,['Unevaluable event'],UNK,MODERNA,IM 928170,MI,57.0,F,"Patient complained of generalized itching at 0900. Denied shortness of breath, sweating, hives. 25 MG of IM Benadryl given at 0936. Patient observed observed after. Patient stated denied itching following Benadryl administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,['Pruritus'],1,PFIZER\BIONTECH,IM 928171,CA,43.0,M,"I'm feeling fatigued, cold/slight chills, lost of apatite, slight nausea, and body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,WRK,None.,None.,None,,None.,"['Chills', 'Decreased appetite', 'Fatigue', 'Feeling cold', 'Nausea', 'Pain']",1,MODERNA,IM 928173,ND,57.0,F,"Nausea, headache, fever, body aches, fatigue. Was seen in clinic and had outpatient treatment consisting of IV fluid, benadryl, fentanyl, tylenol, toradol, and a dose of doxycyline IV due to unable to take oral dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,Doxycycline 100 mg; zanaflex 4 mg; vitamin c 1000 mg; calcium plus d;,COVID-19; RLL pneumonia,,,No known allergies,"['Alanine aminotransferase normal', 'Blood albumin decreased', 'Blood bilirubin increased', 'Blood glucose increased', 'Eosinophil percentage decreased', 'Fatigue', 'Headache', 'Lymphocyte count decreased', 'Lymphocyte percentage decreased', 'Monocyte percentage', 'Nausea', 'Neutrophil percentage increased', 'Pain', 'Protein total decreased', 'Pyrexia']",1,MODERNA,SYR 928174,AR,37.0,M,"Injection site/upper arm soreness, joint pain, insomnia, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PHM,Atorvastatin Vitamin C Zinc,COVID-19 within 3 weeks (tested negative at time of immunization),None,,NO Known Allergies,"['Arthralgia', 'Chills', 'Injection site pain', 'Insomnia']",1,MODERNA,IM 928175,,35.0,M,Just noticed tennis ball size lump under left armpit,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,UNK,N/a,N/a,N/a,,N/a,['Lymphadenopathy'],2,PFIZER\BIONTECH,IM 928176,NV,20.0,M,"01/08/2020 1:00AM injection site pain, chills, nausea, temp 102. headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,OTH,,,,,,"['Body temperature increased', 'Chills', 'Headache', 'Injection site pain', 'Nausea']",1,MODERNA,SYR 928177,FL,68.0,F,"Swelling, blistering at site. Muscle aches, dull headache, severe fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,OTH,,,Hypothyroidism High blood pressure controlled with medication,,Avalon or dexramathophan,"['Fatigue', 'Headache', 'Injection site swelling', 'Injection site vesicles', 'Myalgia']",UNK,MODERNA, 928178,MT,59.0,F,"body aches, sore throat, chills just doesn't feel well",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Chills', 'Malaise', 'Oropharyngeal pain', 'Pain']",1,PFIZER\BIONTECH,IM 928179,CA,,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/01/2021,01/07/2021,6.0,OTH,None,None,None,,Aspirin,['Unevaluable event'],UNK,MODERNA, 928180,IL,30.0,F,"Localized reaction starting the following day. On 1/7/2021 this area was red, warm, slightly indurated and measured 9 cm x 5 cm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,Oral birth control,None,None,,"Penicillin, Citalopram","['Injection site erythema', 'Injection site induration', 'Injection site warmth', 'Local reaction']",1,MODERNA,IM 928182,MT,32.0,F,"Muscle aches, fever, chills. Onset 1/8/21 - employee unable to work next shift due to muscle ache pains",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,birth control,none,none,,none,"['Chills', 'Impaired work ability', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928183,TX,40.0,F,Severe Headaches Body aches Fatigue Chest pain allergies worsened,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/31/2020,3.0,UNK,"Apri 0.15/0.03mg Allegra, Zyrtec",Seasonal Allergies,,,NKA,"['Chest pain', 'Condition aggravated', 'Fatigue', 'Headache', 'Pain', 'SARS-CoV-2 test negative', 'Seasonal allergy']",UNK,PFIZER\BIONTECH,IM 928184,NC,44.0,F,within an hour of receiving the vaccine my skin was hot and red.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,SCH,,,aortic stenosis,,none,"['Erythema', 'Skin warm']",1,MODERNA,IM 928185,AZ,52.0,F,"c/o light headedness, ems evaled pt. declined further treatment. or eval symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 928186,MN,34.0,F,"Left clavicle lymph node is tender and swollen, with swelling radiating to base of neck and up to left ear.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,PUB,None,None,None,,Fish oil,"['Ear swelling', 'Lymphadenopathy', 'Swelling', 'Tenderness']",1,MODERNA,IM 928188,PA,54.0,F,"About 25 minutes after receiving the shot patient became dizzy, jittery and had some palpitations. She was in the parking garage and called 911. She was taken to ED and treated with IV fluids. Her potassium was low and was replaced. Felt better after fluids and was discharged",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,,,,,,"['Blood potassium decreased', 'Blood test', 'Blood thyroid stimulating hormone decreased', 'Chest X-ray', 'Dizziness', 'Electrocardiogram', 'Feeling jittery', 'Palpitations']",1,PFIZER\BIONTECH,IM 928189,NY,49.0,F,"the reaction started 6 days post injection - about the size of a tennis ball the area became red, swollen, hard, hot with minimal pain and itching",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,PVT,NONE,NONE,NONE,,KEFLEX SELDANE TINCTURE OF BENZOIN,"['Erythema', 'Nodule', 'Skin warm', 'Swelling']",1,MODERNA,IM 928193,IN,44.0,F,"Sore arm, Joint pain, Fever, Fatigue, Back pain(muscles in back), Headache x 2 days so far",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"Advair, Lyrica, Levalbuterol, Cyclobenzaprine, Topiramate, Omeprazole, Montelukast Vitamin D3, Mg, Turmeric","Asthma, Complex Regional Pain Syndrome, Fibromyalgia, Functional Myoclonus,","Asthma, Complex Regional Pain Syndrome, Fibromyalgia",,"PNC, Lactose intolerance","['Arthralgia', 'Back pain', 'Fatigue', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 928194,FL,51.0,F,"9 days after vaccine, woke up with red swollen itchy injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/08/2021,9.0,UNK,"zoloft, synthroid and prinivil",None,"High Blood pressure, thyroid disease",,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 928195,GA,22.0,F,Patient called from home and told the CNO she was experiencing fever and chills.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Chills', 'Pyrexia']",1,MODERNA,IM 928197,IN,39.0,F,chills and body aches starting at 3:30 am lasting throughout the day. injection site soreness and axillary lymph node soreness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Chills', 'Injection site pain', 'Lymphadenopathy', 'Pain']",2,PFIZER\BIONTECH,SYR 928199,CA,66.0,M,Adminstration Error : COVID-19 vaccine (IM) given in the Left Ventrogluteal area.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/18/2020,0.0,WRK,,,,,PCN,['Product administered at inappropriate site'],1,PFIZER\BIONTECH,IM 928200,ID,63.0,F,"24 hours after receiving the first dose of covid vaccine, I started having a really bad headache that I could not get rid of even with taking 1000mg of tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,['Headache'],1,PFIZER\BIONTECH,IM 928201,OH,39.0,M,"Moderna COVID-19 Vaccine Vomiting, stomach upset",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/08/2021,2.0,PUB,"Mucus D 600mg, once daily",none,"lactose intolerance, developmentally disabled",,lactose intolerance,"['Abdominal discomfort', 'Vomiting']",1,MODERNA,IM 928202,FL,46.0,F,"Right arm soreness x2 days Right arm warm around injection site x2 days swollen lymph nodes in neck right side, noticed next morning and still current No treatment",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,none,none,none,,Doxycycline- body aches,"['Injection site pain', 'Injection site warmth', 'Lymphadenopathy']",1,MODERNA,IM 928203,MD,64.0,F,Headache persisting7 days,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,OTH,Omeprazole 40mg daily; Singulair 10mg daily; Lipitor 5mg daily; Estring,,"Seasonal allergies, GERD, Hyperlipidemia",,,['Headache'],1,MODERNA,IM 928207,MT,20.0,F,"injection site pain, tiredness, Headache, chills, swollen lymph nodes, feels very unwell",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Malaise']",1,PFIZER\BIONTECH,IM 928208,NJ,45.0,M,"chills, fever fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,SEN,unknown,,,,unknown,"['Chills', 'Fatigue', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 928209,NM,49.0,F,"Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepcid, prednisone",Not Reported,,Yes,Not Reported,,Not Reported,U,01/01/2021,01/07/2021,6.0,PVT,"Losartan, Symbicort, vitamin B complex, loratadine",None,"Hypertension, rheumatoid arthritis, asthma, allergies",,"NKDA, lactose intolerant, possible latex allergy (rash)","['Cough', 'Dyspnoea', 'Headache', 'Lip swelling', 'Nausea', 'Swollen tongue', 'Urticaria']",1,PFIZER\BIONTECH,IM 928210,VA,36.0,F,"Initial fever of 101.6F, now resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,,,,,,['Pyrexia'],1,PFIZER\BIONTECH,IM 928211,MO,26.0,F,"The night of the shot I got a headache, body aches, throwing up, chills, fever, felt dizzy, my whole arm was really swollen, red and hurt. Fast forward to 1-6-2021 I have had a headache ever since and started getting a reaction at the injection site which consist of being swollen, red, a large knot under the red area, the area is really warm and sensitive to touch. I also have pain going up the left side of my neck and down my armpit/lymphatic system.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,none,none,none,,"NSAIDS, Morphine, Zucchini","['Axillary pain', 'Chills', 'Dizziness', 'Erythema', 'Headache', 'Injection site erythema', 'Injection site nodule', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Neck pain', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Vomiting']",1,MODERNA,SYR 928213,IN,50.0,F,Fever of 103 for almost 12 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/06/2021,5.0,OTH,Estrogen Myrbetriq Paxil,,,,,['Pyrexia'],1,MODERNA,SYR 928214,,32.0,F,"Unilateral facial edema/puffiness, fatigue, tenderness at the injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,WRK,Venlafaxine,None,"Obesity, polycystic ovarian syndrome",,NKA,"['Face oedema', 'Fatigue', 'Injection site pain', 'Swelling face']",1,PFIZER\BIONTECH,IM 928215,FL,39.0,F,"Next morning, felt nauseous, vomited, joints and muscle pain, fatigue, bad headache, 101.2 fever",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,WRK,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 928216,KY,26.0,F,"Approached by vaccination staff reporting that a patient who had just received the Moderna COVID-19 vaccination was not feeling well at approximately 1:45 pm. Upon assessment, patient complained of itching all over her body, chest/throat tightness and difficulty swallowing. Called nurse to the scene to assess vital signs and patient continued to complain of above symptoms. Administered (1) epinephrine pen (0.3 mg) to patient's right thigh at 1:50 pm as 9-1-1 was called per protocol. EMS arrived and provided emergency care. Patient was transported to local ER at 2:00 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,Unknown,None reported,None reported,,"Latex, PCN, Lortab","['Chest discomfort', 'Dysphagia', 'Malaise', 'Pruritus', 'Throat tightness']",1,MODERNA,IM 928217,CO,59.0,F,"CDC called and requested I complete this report, but I do see these reactions within the normal range reported to us prior to getting vaccine. 6 hrs after 2nd shot fever of 99, headache, and arm pain. 20 hrs after shot significantly worse headache, arm pain and fatigue to point of not getting up, not walking around, and not interested in eating until later in the day. 30 hrs after shot I was up and eating normally, but continued headache 46 hrs after shot but ibuprofen adequate to cover pain today.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Vit. D, Cranberry supplements",None,Neck tension Of NOTE- History of Covid-19 infection (tested positive on 8/21/2020). Case was moderately severe with 3 months short term disability secondary to fatigue and cognitive deficits that took months to clear to allow resuming work. Never hospitalized for it.,,None,"['Decreased appetite', 'Fatigue', 'Headache', 'Pain in extremity']",UNK,PFIZER\BIONTECH,IM 928218,IN,33.0,F,"Arm soreness, flu like symptoms, chills, sinus pain, overall sick feeling.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,UNK,Arm birth control insert,none,none,flu shot,none,"['Chills', 'Influenza like illness', 'Malaise', 'Pain in extremity', 'Sinus pain']",1,PFIZER\BIONTECH,SYR 928219,VA,115.0,F,"Nausea, diarrhea, tiredness, aches, tachycardia",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,WRK,,,,,,"['Diarrhoea', 'Fatigue', 'Nausea', 'Pain', 'Tachycardia']",1,PFIZER\BIONTECH,IM 928220,AZ,46.0,F,"c/o anxiety ems screened vitals,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,['Anxiety'],1,PFIZER\BIONTECH,IM 928222,,34.0,F,"My upper arm surrounding the injection site got swollen. My arm became hard, hot, and red. It was sore like someone had punched me in the shoulder. It lasted for ~2 days. The first day it was swollen, I felt like I was starting to get sick with a mild headache, and I felt feverish even though I checked my temperature and it was 97 degrees. The second day I no longer felt like I was getting sick and the arm pain was decreasing although it was still swollen, hard, and hot to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,UNK,none,none,none,,"penicillin, nickel","['Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Malaise', 'Pyrexia']",UNK,MODERNA,SYR 928223,MT,57.0,F,"Rash on trunk, Itchiness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 928224,NJ,37.0,F,"first I only had pain in my arm where it was given, throughout the day the pain increased and it became hard to move my arm much, there was some swelling at the site. Later that night I started to have a headache and the next morning I felt so tired and groggy it was hard to get up. I continued to feel exhausted and have difficulty focusing due to the headache and tiredness the entire day. I woke up feeling better the next morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,none,none,none,,"nuts, environmental allergies, NKDA","['Fatigue', 'Headache', 'Injected limb mobility decreased', 'Injection site pain', 'Injection site swelling', 'Somnolence', 'Vision blurred']",UNK,MODERNA, 928225,,39.0,F,"Rash (erythematous, itchy) over injection site that started 1 week after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/07/2021,7.0,PVT,levonorgesteral IUD sertraline,None,asthma,,None,"['Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 928226,OH,49.0,F,"Redness and swelling, size of egg to injection site, in addition itchiness at injection site.Overall had feelings of being achy, tired and sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/29/2020,5.0,PVT,"Effexor, Birth Control Pill",Congestion,None,,Amoxicillin,"['Fatigue', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Pain']",1,MODERNA,IM 928227,VA,115.0,F,"Redness at injection site, pain at injection site, HA, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,WRK,,,,,,"['Dizziness', 'Headache', 'Injection site erythema', 'Injection site pain']",1,PFIZER\BIONTECH,IM 928229,FL,48.0,F,cellulitis and redness of skin. Warm on touch,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/07/2021,9.0,WRK,"Tylenol, Ice Pack",Unknown,Unknown,,Unknown,"['Cellulitis', 'Erythema', 'Skin warm']",1,MODERNA,IM 928230,PA,30.0,F,"Approximately 5 minutes after receiving vaccine her right eye became blurry. No other symptoms. No headache. BP 137/82 Pulse 92. Within 5 more minutes her right eye went dark. She was taken to ED. They did a CT scan and diagnosed her with ocular migraine. She was given benadryl, compazine and IV fluids. Symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,,,,,,"['Blood test normal', 'Computerised tomogram normal', 'Ophthalmoplegic migraine', 'Vision blurred']",1,PFIZER\BIONTECH,IM 928231,TX,46.0,F,"Lymphadenopathy. Lymph nodes under left arm (side of vaccine administration) became swollen and painful. Lasted for approximately 1 week. No treatment, did not see anyone for it. I did not take any over the counter pain medication either. It gradually went away on its own.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,PVT,"Levothyroxine 75mcg PO QD, Fish Oil, Multivitamin, Vit D3",None,None,,"Novahistine, Penicillin","['Lymphadenopathy', 'Vaccination site pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH,IM 928232,MI,33.0,F,Feeling of lump in throat and lightheadedness. Benadryl 50 mg IM given. Symptoms resolved within 2-3 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,"Cyproheptadine, multivitamin",none,"headaches, chronic sinusitis (non-allergic)",,"Glalinium dye, eggplant, pinenuts","['Dizziness', 'Sensation of foreign body']",UNK,PFIZER\BIONTECH,IM 928233,TX,61.0,F,"had slight red rash day following injection that was located one inch below injection site. That mostly resolved within 4 days. On 1/4/2021, the same area turned bright red, raised and extremely itchy ..now 2 inches x 1 inch. Grew larger over course of several days and is now oval shape bright red and warm to touch roughly 5 inches h x 3 inches wide taking benadryl, zyrtec, pepcid , and using topical clobetasol to area still ongoing. have seen my asthma allergy doctor",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PHM,"serevent , pulmicort, singulair , detrol la ,mucinex , zyrtec, biotin, vitamin d, co Q 10 , syntyroid, multivitamin",asthma cardiac arrhythmia hematuria osteoporosis arthritis,asthma cardiac arrhythmia hematuria osteoporosis arthritis,,iodine dye,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site reaction', 'Injection site warmth', 'Rash erythematous']",UNK,MODERNA,IM 928234,TX,53.0,F,About 9 days after injection in the evening I started feeling fatigued. the 10 day I and ran a temperature of 100.2 so I took ibuprophen I also had some hip pain. I Called the urgent care and scheduled PCR COVID test for 1/8/21. 1/8/21 I started feeling better. No fever. i think it was a delayed reaction,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/06/2021,9.0,PUB,Azithromycin,stye,no,,no,"['Arthralgia', 'Body temperature increased', 'Fatigue', 'SARS-CoV-2 test']",1,MODERNA,SYR 928235,LA,45.0,F,"Left arm became sore at injection site 7 days post injection, today is 9 days post injection and left arm is swollen with a red area the size of 2 golf balls",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,WRK,"Quasense Birth control, Lipitor, Lexapro, Biotin",None,None,,None,"['Injection site erythema', 'Injection site pain']",1,MODERNA,IM 928236,TN,45.0,F,8 hours after receiving Moderna injection I spiked a fever. Highest temp was 102.6 - fever lasted for approx. 12 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,"Vyvanse, vitamin B, vitamin D, probiotic",none,autoimmune disease,,none,['Pyrexia'],1,MODERNA,SYR 928237,AZ,59.0,F,"tingling tounge and flushed, monitored until resolution,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Flushing', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 928238,VA,39.0,U,"Pain in arm, aches in body",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,WRK,,Had COVID 10/2020,,,,"['Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 928239,NJ,42.0,F,"Left shoulder pain since injection. Nine days after vaccine was given developed an enlarged left suprclavicular lymph node, then on day 10 developed red warm painful patch below the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,PVT,"Wellbutrin 300mg QD,and Nexium 40mg daily, Ibuprofen 600mg as needed",none,GERD and Depression,,"Penicillin, Ancef and Minocycline","['Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Lymphadenopathy']",UNK,MODERNA, 928240,PA,33.0,F,"Less than 5 minutes after vaccine, nose drained, weird taste in mouth, tingle in nose and on tongue. Throat and tongue swelled, couldn?t speak. Dizzy and slurring speech. Was taken to ambulance outside, BP was 191/101. Given beta blockade. Confused and dizzy for next 2 hours in ER. Evaluated for stroke and given a 12-lead ECG. Given benedryl and prednisone. Felt better after 3 1/2 hours. Continued steroids for 5 days and had to take benedryl every 4 hours for 3 days or swelling/itching/bad taste in mouth would return. Sore arm on day 3.",Not Reported,,Yes,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"Zoloft, prenatal vitamins, DHA",None,None,,"Nickel, grass, latex, dairy? all mild skin reactions","['Confusional state', 'Dizziness', 'Dysarthria', 'Electrocardiogram', 'Mouth swelling', 'Oral pruritus', 'Pain in extremity', 'Paraesthesia', 'Paraesthesia oral', 'Pharyngeal swelling', 'Rhinorrhoea', 'Swollen tongue', 'Taste disorder']",1,MODERNA,IM 928241,KY,45.0,F,On day 9 the injection site started itching and was very aware of the exact spot. The next morning I woke up with a visibly raised area on and around the injection site. It feels itchy and achy. I have a slight tingling sensation down the underside of my right arm from my armpit to my palm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,Fluoxetine 25mg 2t qd Oxybutynin 10mg ER 1t qd Vitamin D,None,None,,None,"['Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Paraesthesia']",1,MODERNA,IM 928243,IN,28.0,F,"Symptoms started around midnight on 1/7/2021 Symtpoms: Burning red face, entire body was itchy, tongue and inside of the mouth was itchy, rash on upper body and swollen inflamed painful lips.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PUB,Buproprion Prozac Zinc Vitamin C B-100 Complex Melatonin,Tested positive for COVID in early December,Asthma Severe Allergies,,Ceclor,"['Burning sensation', 'Erythema', 'Lip swelling', 'Oral pruritus', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH,SYR 928245,NC,48.0,F,"Lethergic/very tired two days post injection, and on 1/5/2021 golf ball size warm to touch red area at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/05/2021,6.0,PVT,"Mobic 15 mg daily. Norvasc 10 mg daily, Lipitor 10 mg daily, Prilosec 40 mg daily",None,"High blood pressure, GERD, high Cholesterol, foot pain",,Morphine,"['Fatigue', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Lethargy']",1,MODERNA,SYR 928246,MT,25.0,F,"headache, went away, injection site and redness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Headache', 'Injection site erythema']",1,PFIZER\BIONTECH,IM 928247,PR,59.0,F,"ON DAY # 8 AFTER VACCINE; HEADACHE, REDNESS, SWELLING. TREATMENT OTC: TYLENOL, BENADRYL, CALADRYL LOTION PLUS COLD COMPRESSES",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,SCH,"LANSOPRAZOLE, CALTRATE 600, VIT D3 -1000 MG, IBANDRONATE 150 MG, VIT B COMPLEX",NO,NO,,NO,"['Erythema', 'Headache', 'Swelling']",1,MODERNA,IM 928248,OH,33.0,F,"red, raised, warm to touch rash on upper left arm below injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,IC Clobazam 2.5 mg/ml susp Carafate 1gm/10ml susp Levetiracetam 100 mg/ml solution Amitriptyline 75 mg tap Clonazepam .5 mg Baclofen Omeprazole 2mg/ml Amino Acid Mix IC Sodium Chloride TAURINE Culturelle,none,TBI CP secondary to TBI seizures esophageal reflux spastic quadraplegic scoliosis,,"Maxipime, Reglan, antihistamine","['Injection site erythema', 'Injection site rash', 'Injection site reaction', 'Injection site warmth']",1,MODERNA,IM 928251,WV,60.0,F,"Approximately 20 minutes post injection patient felt tingling/numbness in the left pinkie finger, migrated to right pinkie finger with one hours. Acetaminophen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,declined to provide,none,hypertension,,None,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 928253,VA,54.0,F,"Headache, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,WRK,,,,,,"['Headache', 'Nausea']",1,PFIZER\BIONTECH,IM 928254,MO,46.0,F,"Soreness in the left arm, 2 inch ribbon of rash a few inches below the injection site, (headache/migraine occurred 24 hours after the vaccine for a few days)",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,"Multivitamin, vitamin C, Vitamin D, Fish oi, and Digestive enzyme",Sinus infection,IGA deficiency and autoimmune disease,,Mold,"['Headache', 'Injection site rash', 'Migraine', 'Pain in extremity']",1,MODERNA,IM 928256,CA,22.0,F,"On 12/30/2020 I received my 1st dose of Pfizer vaccine. Felt fine, no symptoms or side effects until 12/31/2020 I did get hives on my arm site where I received the vaccine and those hives then started to spread throughout my body. I started having hives and rashes all over for a total of 6 days . Itching, swelling on my ears, arm, wrist, hands, back etc... took Benadryl for the 6 days and it helped for the 1st 2 days of my adverse event after that the Benadryl did nothing. Me and my PCP has agreed it was a possible delayed allergic reaction to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Ear swelling', 'Injection site urticaria', 'Joint swelling', 'Peripheral swelling', 'Pruritus', 'Rash', 'Swelling', 'Urticaria']",1,PFIZER\BIONTECH,IM 928258,IN,30.0,F,"Over night on 01/06 I experienced chills and was very cold. At times I was extremely warm. The next morning I had a fever and my joints, muscles, head and even my skin was hurting. My fever never came down to normal even with advil and I was extremely tired all day. The arm that had the injection is extremely sore with splotches of red (which is expected.) Today, 01/08, I woke up in a pool of sweat. My head is still hurting and I still have a fever. My arm is still sore but my skin and joint pain has improved. I am still very cold. Have been wearing my winter coat in my house even with the heat and the fire place on. I had to take the last two days off work.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"Vitamin D, zyrtec, melatonin",None,None,,None,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Impaired work ability', 'Myalgia', 'Pain in extremity', 'Pain of skin', 'Pyrexia', 'Rash macular']",1,PFIZER\BIONTECH,SYR 928260,TX,26.0,F,redness and swelling a week after injection .,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,UNK,,,,,,"['Erythema', 'Swelling']",1,MODERNA, 928262,IN,23.0,M,"Day of injection: weakness and site pain Next day: Fever, skin hot but shivering cold (chills), headache, body aches Day 2: same as next day but less severe",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,,,Bicuspid aortic heart valve,,"Codein, Nickel","['Asthenia', 'Chills', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia', 'Skin warm']",UNK,MODERNA, 928263,MT,25.0,F,"headache, went away, injection site and redness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Headache', 'Injection site erythema']",1,PFIZER\BIONTECH,IM 928264,MA,50.0,M,"I developed symptomatic palpitations that started on 12/23 in the early morning, awaking me from sleep. Palpitations became so frequent that I went to my PCP's office, where I was found to have an abnormal rhythm on my EKG (non-sustained V-tach, runs of 4-5 beats at a time). I then went to hospital where I was admitted to observation in the ED for monitoring.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/23/2020,5.0,PVT,Amlodipine 5 mg,None,Hypertension,,NKDA,"['Blood magnesium normal', 'Electrocardiogram normal', 'Full blood count normal', 'Heart rate abnormal', 'Metabolic function test normal', 'Palpitations', 'Sleep disorder', 'Troponin normal', 'Ventricular arrhythmia', 'Ventricular extrasystoles']",1,PFIZER\BIONTECH,IM 928265,TX,38.0,F,"Nausea, dizziness and swelling of lips started 1-2 hours after receiving COVID vaccine, took Benadryl with improvement of symptoms, the following day noticed that the swelling of lips had come back, still nauseated and dizzy to a lesser degree. Patient was treated with Methylprednisolone acetate 40 mg IM, advised to take Pepcid 20 mg PO BID and Benadryl 25-50 mg PO PRN. As of today (01/08/2021) patient is feeling better, lips are not swollen, no nausea or dizziness reported, she is back to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Trazodone 150 mg PO daily Citalopram 10 mg PRN anxiety,None,Anxiety Insomnia,,"Minocycline, Doxycycline, Phenergan Oranges, Strawberries, Pineapple flavor","['Dizziness', 'Lip swelling', 'Nausea']",UNK,MODERNA,IM 928266,FL,36.0,F,"soreness at injection site, fatigue, chills, body aches, joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,"vitamin B and C, fish oil",None,None,,NKA,"['Arthralgia', 'Chills', 'Fatigue', 'Injection site pain', 'Pain']",2,PFIZER\BIONTECH,IM 928267,NC,43.0,F,"on day 7 after getting vaccine, injection site became extremely itchy. Over the course of the day became very red and swelling increased to size of a baseball.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PUB,Cymbalta Ambien Levothyroxine Phentermine Gabapentin Tramadol,,Hyshimotos Disease restless leg syndrome Anxiety,,Benzoyl Peroxide-redness and swelling of face,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 928269,FL,75.0,F,Continuous itching at the site since symptoms first began. It is still itching 1.5 days since I received the shot. There is no swelling or redness.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,Glucosamine Chondroitin,NONE,NONE,,NONE,['Injection site pruritus'],1,MODERNA,SYR 928270,CA,31.0,F,"LARGE (20 BY 20 CM.) ERYTHEMATOUS MASS AT INJECTION SITE SIX DAYS FOLLOWING INJECTION, NO TREATMENT BY INDIVIDUAL, I AM INFECITON PREVENTION: ON 1/6/2021 I VIEWED AND RECORDED THE ARM SWELLING, ADVISED OTC BENADRYL 25 MG WHEN NOT DRIVING AND IMMEDIATE APPLICATION OF A COLD COMPRESS. ON 1/7/2021 BY PHONE THE INDIVISDUAL STATED SHE WA SNOT ANY BETTER AND I REFERRED HER TO HER PHYSICIAN.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,WRK,NONE,NONE,PANCREATITIS,,NONE,"['Injection site erythema', 'Injection site mass', 'Peripheral swelling']",1,MODERNA,IM 928271,PR,43.0,M,"AT 3AM STARTED WITH FEVER AND CHILLS , HEADACHE, SEVERE BODYACHE, LOWER BACK PAIN AND FATIGUE TAKING TYLENOL EVER 4 HRS SINCE 3AM 1/8/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,WRK,ACETAMINOPHEN,NO,NO,,NO,"['Back pain', 'Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928272,VA,34.0,F,"Chills, tiredness, headache, malaise, swelling in arm",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,WRK,,,,,,"['Chills', 'Fatigue', 'Headache', 'Malaise', 'Peripheral swelling']",2,PFIZER\BIONTECH,IM 928273,,51.0,F,"Axillary soreness /pain in the same arm of the injection site. Urticaria, covering most of the deltoid muscle, with slight swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/07/2021,7.0,UNK,,,,,sulfa,"['Axillary pain', 'Peripheral swelling', 'Urticaria']",1,MODERNA,IM 928275,TX,33.0,M,"Symptoms - ? at time of vaccine, pain at injection site, worsening overnight. EE reports arm as feeling heavy. EE reports unable to sleep over night and tossed and turned. EE reports feeling chilled this am and took temperature. Tmax 102.2 taken at 08:45. EE reports + runny nose and congestion. EE denies travel and COVID-19 exposure without proper PPE. Home remedies? - motrin 600 mg at 08:55 Any improvement? ? none at this time Recommendation? After completely algorithm, EE meets criteria to be COVID tested and removed from work at this time. EE provided with EH command center and instructions to notify them need for COVID-19 testing. EE educated to notify his manager. EE verbalized back understanding and denied further questions at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Injection site pain', 'Limb discomfort', 'Nasal congestion', 'Pyrexia', 'Rhinorrhoea', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 928276,AZ,73.0,M,"headache neck stiffness, resolved during observation period.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Headache', 'Musculoskeletal stiffness']",1,PFIZER\BIONTECH,IM 928277,NE,57.0,F,Egg sized swelling/red/firm area over injection site 12/30/20 to 1/1/21. I had been taking Zyrtec prior to that. I was more concerned when that area resolved and then a larger softball sized area reformed on 1/6/21 which is red/dark red hard and raised. I was off Zyrtec by then and had started Lisinopril on 1/1/21 for high BP.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,WRK,Zertec,post nasal drip elevated BP,allergies- stopped taking Zyrtec 12/30/20 before starting medication for BP elevated BP- started treating 1/1/21 with Lisinopril,,antibiotics nickel,"['Injection site erythema', 'Injection site induration', 'Injection site swelling']",UNK,MODERNA,IM 928278,IA,37.0,F,"Patient did not have any symptoms on the day injection was given. The next day was running an elevated temp over 101F , Noticed a lump on left shoulder. Site very tender and has continued to spread up neck and down to breast. Also states she has tingling in fingers. Site where injection given is slightly swollen and tender. Had her come to our",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PHM,,,,,,"['Body temperature increased', 'Breast tenderness', 'Injection site mass', 'Injection site pain', 'Paraesthesia', 'Tenderness']",UNK,MODERNA,IM 928279,SC,59.0,F,"An area (approximately the size of a medium orange) of itchy bumps came up on my chest several hours after the injection. It is not painful and I did not notice it anywhere else, just the area on the upper right side of my sternum.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PUB,"singulair, HR therapy, blood pressure meds, chantix, Vitamin D, Volteran","early December, respiratory issues (severe cold, chest congestion) , Covid test- Negative",Annual Bronchitis every winter (normally only once at season change),,sensitivity to codeine (makes me itch),"['Rash', 'Rash pruritic']",UNK,MODERNA, 928280,TX,58.0,F,"started shaking chills late evening 1/7 (did not take temp). In morning 1/8 leg weakness, generalized weakness/fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,,,,,,"['Asthenia', 'Chills', 'Fatigue', 'Muscular weakness', 'Tremor']",1,MODERNA,IM 928281,VA,35.0,F,Intermittent numbness in hands,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,,,,,,['Hypoaesthesia'],1,PFIZER\BIONTECH,IM 928282,TX,51.0,F,"My arm was swollen , Large welt at the injection site. My hands were itching and swelling Inside of my mouth was tingling Hard to breathe Bad Headache 12/23/2020 Benadryl- IV",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,Tramadol risperdal Citalopram Vitamin C Vitamin D Synthroid,,Lupus Rheumatoid arthritis,"tetanus- Welts , hives. Eyes swollen shut, Hard time breathing .",tetanus,"['Dyspnoea', 'Headache', 'Injection site reaction', 'Paraesthesia oral', 'Peripheral swelling', 'Pruritus', 'Urticaria']",1,MODERNA,IM 928283,WI,38.0,F,Clinic Manager reports that EE received first dose Covid-19. EE reports that after 15 minutes EE became unwell and was sweating. EE reports that EE was seen in clinic by providers and had elevated blood pressure and hives,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,,,Unknown,,,"['Blood pressure increased', 'Hyperhidrosis', 'Malaise', 'Urticaria']",1,PFIZER\BIONTECH,IM 928284,CA,61.0,F,Tonsils swollen Throat felt like it was closed,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Throat tightness', 'Tonsillar hypertrophy']",1,MODERNA,SYR 928286,IA,36.0,F,"1/4/21: Severe headache, not relieved with OTC meds or prescription migraine meds. 1/7/21: itchy rash/hives on arm, legs, back and under chin. One dose of Benadryl at that time with no relief.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,WRK,,,,,,"['Headache', 'Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 928287,IL,50.0,F,"01/08/2020 2:00AM extreme pain in arm at injection site ; 11:00AM chills, jaw pain, fever 103. 2, Tylenol reduced fever to 100.8, body aches and joints, slight cough",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Lisinopril, Hydrochlorothiazide, Flordipine Vitamin D 4,000IU, Vitamin C 1,500MG",Covid 19 12/04/2020-12/18/2020,"High Blood Pressure, palenkinises disease",,,"['Arthralgia', 'Chills', 'Cough', 'Injection site pain', 'Pain', 'Pain in jaw', 'Pyrexia']",1,PFIZER\BIONTECH,IM 928288,IL,68.0,F,Resident sent to hospital with respiratory distress and low oxygen,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,SEN,,,,,,"['Oxygen saturation decreased', 'Respiratory distress']",1,MODERNA,IM 928289,MT,45.0,F,vomitting,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,['Vomiting'],2,PFIZER\BIONTECH,IM 928290,IN,35.0,F,"Fast heart rate, dizziness, fatigue, fever, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,None,None,None,,None,"['Dizziness', 'Fatigue', 'Heart rate increased', 'Pain', 'Pyrexia']",1,MODERNA,IM 928291,WI,69.0,F,symptoms:chest and stomach pain Has markedly elevated liver function tests that were normal 2 weeks prior to immunization Is being admitted the hospital to monitor liver function test.,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/04/2021,01/05/2021,1.0,SEN,"Cevimeline, diphenhydramine, escitalopram, fluticasone, folic acid, hydroxychloroquine, loratadine, multivitamins, pantoprazole, Synthroid. methotrexate and etanercept. These two medications were last taken on 12/28/2020 and then held by",,"hypothyroidism, sjogren's syndrome, sicca syndrome, celiac sprue",,gluten and penicillin,"['Abdominal pain upper', 'Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood alkaline phosphatase increased', 'Blood bilirubin increased', 'Chest pain', 'Hepatic enzyme increased', 'Liver function test increased']",1,MODERNA,IM 928293,PA,38.0,F,"?Moderna COVID?19 Vaccine EUA? - Flu like symptoms including body aches, muscle pains, joint pains, red/blotchy face, minor itchy ness, tired, fatigue , pain at the injection site, left arm pain, feeling of swollen hands/joints",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Zoloft, Nuvigil, Ritalin",None,Just continuous issues since having Covid in May 2020,,"Walnuts, almonds, dairy, eggs, environmental","['Arthralgia', 'Erythema', 'Fatigue', 'Influenza like illness', 'Injection site pain', 'Joint swelling', 'Myalgia', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Rash macular']",1,MODERNA,SYR 928294,OR,30.0,U,VACCINE ERROR: This was the second dose in the series. Second dose was administered 16 days after the first dose. Initial dose was given 12/20/2020.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,unknown,unknown,unknown,,unknown,['Inappropriate schedule of product administration'],2,PFIZER\BIONTECH,IM 928295,VA,115.0,F,Redness at injection site and pain in arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,,,,,,"['Injection site erythema', 'Injection site pain']",1,PFIZER\BIONTECH,IM 928296,KS,59.0,F,Mild headache and injection site soreness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Daily: Zoloft 100mg Bupropion 100mg Vitamin D 2000 IU Mag citrate 200mg Prevacid OTC Vitamin B+,No,GERD SAD,,"Penicillin, macrodantin, Septra","['Headache', 'Injection site pain']",1,PFIZER\BIONTECH,IM 928297,NC,34.0,F,"Extreme redness, swelling, burning, blistering at injection site starting 1 week after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PUB,Sprintec birth control Lexapro,None,None,,None,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site vesicles']",UNK,MODERNA,IM 928298,,59.0,F,"Patient developed dry mouth and dificulty swallowing 11 min after vaccination, lasted 30 min. Has lingering post nasal drainage.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PUB,"Lisinopril, simvastatin, sertraline",,"mild intermittent asthma, anxiety",,Sulfa Drugs,"['Dry mouth', 'Dysphagia', 'Upper-airway cough syndrome']",UNK,PFIZER\BIONTECH, 928299,MN,44.0,F,"Chills, headaches, extreme fatigue, muscle soreness, ongoing redness below the injection site, elevated heart rate, mild shortness of breath. I slept 11.5 hours the next night after receiving the vaccine, which seemed to help with symptoms. *I had a Covid infection in August 2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"Wellbutrin, Zoloft, multivitamin, Renafood, Vitamin D, CBD",None,"Depression, anxiety, chronic fatigue, PTSD",,"Tetracycline Honey, bananas, avocados, yellow squash","['Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Heart rate increased', 'Injection site erythema', 'Myalgia']",UNK,MODERNA,IM 928300,AZ,33.0,U,anxiety went home and took antianxiety.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,PVT,,,,,,['Anxiety'],1,PFIZER\BIONTECH,IM 928302,TN,38.0,M,BELLS PALSEY ON LEFT SIDE ON DAY 11 AFTER VACCINE. FUNCTION HAS ALMOST FULLY RESOLVED AFTER A MEDROL DOSE PACK WAS STARTED.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,01/01/2021,11.0,PUB,none,none,none,,No known allergies,"[""Bell's palsy""]",1,PFIZER\BIONTECH,IM 928303,WI,33.0,F,"Swelling of tongue, lips and face. Hives. Benadryl administered on site. Rapid Response team called. Patient was transported to ED. In ED received IV solumedrol, IV fluids and EPI X 1. Full recovery. Discharged from ED to home on 4 days of prednisone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"MVI, Effexor-XR, Junel FE, Loratadine, Gabapentin",None reported,"Back pain, headaches, ADHD",,"Cyclobenzaprine, Lactase, Latex","['Lip swelling', 'Swelling face', 'Swollen tongue', 'Urticaria']",1,PFIZER\BIONTECH,IM 928304,AZ,35.0,F,BODY ACHE (LEFT UPPER ARM) POST COVID VAC. SHOT,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,PVT,,,,,,"['Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 928305,WI,31.0,F,"fever, chills, body aches, extreme fatigue, headache, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/03/2021,4.0,UNK,"famotidine, escitalopram, melatonin, claritin",,,,none,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 928306,MI,56.0,F,"I became ache all over, fever of 100.7. Severe headache and nausea. That has past and now, can not taste and smell and congested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Wellbutrin 300mg, Losartan 15 mg",no,no,,morphine,"['Ageusia', 'Anosmia', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 928307,,30.0,F,"Patient received the Covid-19 vaccine. 10 min after the vaccine she reported a feeling that her heart was racing, felt light headed, no throat tightness. Her initial b/p was 150/95 HR 145 sao2 100% Slightly pale in appearance. After about 5 minutes she reported feeling better, she drank water, ate pretzels. She was observed to a total of 30 minutes. Recheck of her B/P 144/80 HR 76 100 % sao2 . Pt left on her own accord Ambulatory. She will follow up in the ED if her symptoms return or for any concerns.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Dizziness', 'Pallor', 'Palpitations']",2,PFIZER\BIONTECH,IM 928308,IN,57.0,F,"About one minute after receiving the injection, ( approximately 9 AM) I felt my heart rate increase to about 100 bpm, and I just did not feel right. I told the nurses I didn't feel right, and I sat down for about 10 minutes and drank 3 glasses of water. Initially I felt better, but then I felt weak and ""not right"", so I lay down on a cot for approximately 40 minutes. My B/P was elevated (165/95), which is very high for me. I did not have any trouble breathing. I continued to drink water, and eventually my B/P lowered, and I felt better. I took an antihistamine (10 mg Zyrtec) when I arrived home at 11:00 AM, and felt very tired until about 3:30 PM, when I felt just about back to normal. I was assessed by an ER physician at the clinic site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Multi vitamin daily, magnesium supplement daily",none,none,,"Sulfa drugs (sensitivity, causes a headache) Bee stings (required epi-pen use for multiple bee stings 7/2015)","['Asthenia', 'Blood pressure increased', 'Fatigue', 'Feeling abnormal', 'Heart rate increased']",1,MODERNA,IM 928309,TX,36.0,M,"Patient noted on vaccine follow-up that developed fever, chills the evening after vaccine. Patient obtained COVID test that was positive. No symptoms were experienced prior to vaccine. Likely unknown exposure to COVID prior to vaccine. Patient did not note need for hospitalization for COVID and recovering at home. Feels better at the time of follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['COVID-19', 'Chills', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 928310,NY,44.0,F,"Next few days had a normal reaction-fatigue, joint pain that lasted for approximately 3-4 days. 8 days later developed a reaction at injection site-redness, swelling, warm to touch, nerve pain radiating down arm. Treated with OTC Antihistamine, ibuprofen and topical cortisone cream. Also, nasal congestion and slight sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,PVT,None,None,Mild asthma,,None,"['Arthralgia', 'Fatigue', 'Injection site erythema', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Nasal congestion', 'Neuralgia', 'Oropharyngeal pain', 'Pain', 'Pain in extremity']",UNK,MODERNA,IM 928312,CO,56.0,F,"Swelling, red blotches, itchy( on arm where the vaccine was given)severe headache, pain in left side by hip bone, sharp pain, cotton mouth(extremely thirsty) and tightens of chest",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,"Aspirin 81mg,fenofibrate 67mg,Vitaman B-121200mcg, Bupropion 450mg,Rosuvastatin 40 mg, Nortripyyline 10mg, Estriol/Estradiol Compound 5.6/1.4mg, Progesterone 200mg",None,IBS and high cholesterol,,Sulfa,"['Arthralgia', 'Chest discomfort', 'Erythema', 'Headache', 'Oral discomfort', 'Peripheral swelling', 'Pruritus', 'Rash macular', 'Thirst']",1,MODERNA,SYR 928313,NJ,,U,"2nd day after getting the vaccine I woke up and my joints were hurting especially my knees. 1/2 My arms started hurting and the injection site swelled up about the size of my arm and it turned red, hard and itchy. I also felt very tired. The symptoms went away about a week later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,WRK,"potassium citrate, hydrochlorotchiazide",no,seasonal allergy,,no,"['Arthralgia', 'Fatigue', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Monoplegia']",1,MODERNA,SYR 928314,NJ,52.0,M,Severe nasal congestion within hours. Loss of smell and taste. Following day of vaccine received my Positive PCR test results for Covid 19. Tested negative 12 days prior.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,UNK,Vitamin C - multi vitamin- and zinc,None,None,,None,"['Ageusia', 'Anosmia', 'COVID-19', 'Nasal congestion', 'SARS-CoV-2 test positive']",1,MODERNA,SYR 928315,,28.0,F,"Day 7 injection site is red, swollen and itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,None,None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 928316,NC,42.0,F,severe migraine lasting more that 24 hours with out relief from Imitrex,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,celexa claritan,,asthma migraines,,avocados codeine penicillin,['Migraine'],1,MODERNA,SYR 928317,AZ,46.0,M,Taste of metal in my mouth for approximately 1 hour.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,"Simvastatin, warfarin, vardanafil",None,Lupus anti- coagulant syndrome,,Penicillin,['Dysgeusia'],1,MODERNA,IM 928318,CO,50.0,F,"headache, sore throat, runny nose, arm pain that migrated to the axilla and down the side of the body, joint pain ( hands, wrist, feet, hips, knees, spine, neck), insomnia, general malaise, fatigue, and lower grade fever. Most symptoms lasted about 7 -10 days. However, it is now day 20 after the initial vaccine and I still have joint pain that has not gone away. esp in hands, wrists, and feet. When I sleep I still wake up with all my joints hurting it gets better as I start moving but the wrist, hands, and feet pain has not gone away. This pain will wake me in the night when I change positions. I called my doctor today to inquire if it is a good idea if I should take the second dose because the first dose made me so dibiliated. Awaiting for a response. I am due to take the second vaccine on 2/9/21.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/19/2020,12/19/2020,0.0,PVT,none,none,"Raynaud's syndrome, spondylolisthesis","Flu vaccine/ quaderavlent every year/ symptoms last about 5 days then goes away. face swelling, body aches, pains, joint pain, l",preservatives in clothing and furniture.,"['Arthralgia', 'Asthenia', 'Axillary pain', 'Fatigue', 'Headache', 'Insomnia', 'Malaise', 'Oropharyngeal pain', 'Pain in extremity', 'Pyrexia', 'Rhinorrhoea', 'Sleep disorder', 'Spinal pain']",1,PFIZER\BIONTECH,IM 928319,CA,35.0,F,"Tachycardia 160?s, Sharp Left Jaw Pain, Left Facial Swelling, Tingling/Numbness Roof of Mouth and Tongue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,One a day Women?s Vitamin,None,"Hypothyroidism, restarted meds 1/8/2021","Flu Vaccination October 2020, Tachycardia","None Recent similar but mild reaction to Flu Vaccine on Oct 30, 2020","['Hypoaesthesia oral', 'Pain in jaw', 'Paraesthesia oral', 'Swelling face', 'Tachycardia']",1,PFIZER\BIONTECH,IM 928320,KS,59.0,F,Mild headache and injection site tenderness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/17/2020,1.0,PVT,Daily: Zoloft 100mg Bupropion 100mg Vitamin D 2000 IU Mag citrate 200mg Prevacid OTC Vitamin B+,No,GERD SAD,,"Penicillin, macrodantin, Septra","['Headache', 'Injection site pain']",1,PFIZER\BIONTECH,IM 928322,OH,56.0,F,Pt has hives for 2-3 days after injection starting 2 hours after injection. She also stated redness/itching to injection site. In addition fatigue after injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Metformin,none,Pre- diabetic,,Sulfa,"['Fatigue', 'Injection site erythema', 'Injection site pruritus', 'Urticaria']",UNK,MODERNA,IM 928323,FL,68.0,F,Soreness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,Sertraline 50 mg/d,None,None,,None,['Injection site pain'],1,MODERNA,IM 928324,MT,45.0,F,"dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness negative Covid test",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Chest discomfort', 'Cough', 'Dizziness', 'Fatigue', 'Heart rate increased', 'Injection site pain', 'Respiratory tract congestion', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 928326,MA,28.0,F,Fever (chills and sweating) Sharp pain in arm of injection Nausea and vomiting Full body aches Low energy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Zoloft Tri-Sprintec birth control Vitamin D3 supplement,No,No,,"Allergies to foods: wheat, gluten, soy, fish, peanuts, dairy","['Asthenia', 'Chills', 'Hyperhidrosis', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",1,MODERNA,SYR 928327,MN,37.0,F,"started feeling ""funny"" about 30 minutes after her second covid vaccine. She returned to the covid vaccine clinic at 0928. She had returned to work in the clinic and let her coworkers know how she was feeling. She was given 50 mg PO liquid Benadryl at 0907 due to tingly, full-feeling tongue, and stated her ""teeth and face feel funny"". VS at 0915: BP 128/85, P 88, O2 100%. VS 10 mintues later (30 min after Benadryl) were: BP 118/74,P 77,O2 100%. She reports that the tingling and fullness of her tongue is much better. Her color is normal, and she is visiting with staff. Will plan to monitor for one hour.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Zoloft 50 mg B12 shot - last dose Monday Zinc Vitamin D,None,None,,NDKA,"['Feeling abnormal', 'Hyperaesthesia teeth', 'Paraesthesia oral', 'Tongue discomfort']",2,PFIZER\BIONTECH,IM 928328,PA,27.0,F,"Fever, chills, severe dizziness. Unable to even sit at the side of the bed without baseline out. (I do have pots but have been fully function without any currently symptoms of that)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Lialda, prenatal vitamins","Ulcerative colitis, pots",See above,,None,"['Chills', 'Dizziness', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928329,FL,67.0,M,Exacerbation of psoriasis on hands,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/04/2021,6.0,UNK,"Pravastatin Aspirin Advil Vitamin c, d,",Psoriasis,,,,"['Condition aggravated', 'Psoriasis']",UNK,MODERNA,IM 928330,TX,44.0,F,"Symptoms - ? 1/7 at approximately 2:00 pm: feelings of nausea; 10:00 pm: myalgias, midnight: chills and fever (Tmax 101.3). EE denies COVID-19 exposure without proper PPE and denies travel. Home remedies? - none Any improvement? ? at time of call at approx. 9:10 am, EE reports significant improvement in symptoms and denies fever at this time Recommendation? EE encouraged to continue to monitor her symptoms and to call vaccine support line with further questions/concerns. EE verbalized back understanding and denied further questions at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Chills', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928331,TN,45.0,F,"After the vaccine few hours later my left arm went numb. I went to the ER physician told me that was not a reaction to the vaccine and prescribed me a prescription for Prednisone, Allergy medication. I missed a total of I hour 1/2 from work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PUB,"Nexium, Tylenol, Benadryl",No,"Allergies, Irritable bowel Syndrome, Heartburn",,"Iodine, Mushrooms, Dust, Mold, Flowers, Avocados, Strawberries","['Hypoaesthesia', 'Impaired work ability']",1,MODERNA,IM 928333,NM,76.0,M,"Fever, coughing, drowsiness, generalized weakness. Was found to be hypercalcemic (corrected calcium 14) and admitted 1/2-4. No prior history of hypercalcemia.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,insulin detemir 10 units daily losartan 25mg daily simvastatin 60mg daily glipizide 5mg daily vitamin D calcium,none known,sarcoidosis h/o colon cancer in remission,,lisinopril - swelling,"['Adjusted calcium increased', 'Asthenia', 'Blood calcium increased', 'Cough', 'Hypercalcaemia', 'Pyrexia', 'Somnolence']",1,MODERNA,IM 928335,,59.0,M,"pt was awoken at 11pm with severe abdominal pain from the diaphragm and wrapping around to the right flank and back. pt described the pain as ""burning"" and she had 1 episode of vomiting. The next day she found ""2 red circles"" on her left lower back.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Abdominal pain', 'Burning sensation', 'Erythema', 'Vomiting']",1,MODERNA, 928337,MT,45.0,F,"dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness y negative Covid test",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Chest discomfort', 'Cough', 'Dizziness', 'Fatigue', 'Heart rate increased', 'Injection site pain', 'Nasal congestion', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 928338,,27.0,F,"Complained of dizziness and feeling like she will pass out. Client in back of Jeep lying down with feet elevated. 11:35am client states less dizzy and sitting up drinking soda. 12:01 vital signs stable; ambulating well, color pink, denied dizziness, pruritus. Left site in stable condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PUB,,,,,,['Dizziness'],1,MODERNA,UN 928339,CO,,F,"Developed a infrapopliteal DVT in the left leg two days after vaccine was received. I also had minor knee surgery on December 18, four days prior to receiving the vaccine. No risk factors/medical history for developing a DVT.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/24/2020,2.0,PVT,oxycodone 5mg Q4h,,,,none,"['Deep vein thrombosis', 'Ultrasound scan']",1,PFIZER\BIONTECH,IM 928340,SC,54.0,F,right arm started tingling about 15 minutes after vaccine. Rash started on left wrist/forearm area. Took Benadryl and Zyrtec...symptoms subsided.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,unknown,unknown,unknown,,unknown,"['Paraesthesia', 'Rash']",1,PFIZER\BIONTECH,IM 928341,MN,69.0,F,"Patient ran a fever of 100.2, had redness, swelling, and hardness at the injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,SEN,"Lipitor, Omeprazole, Remeron, Gabapentin, Nortriptyline, Lamictal, Xanax, Cymbalta, Xarelto",11/23/2020 Covid +,"DM, Spinal Stenosis, Alzheimer's, Dementia, Anxiety, GERD, Hyperlipidemia, tremors, chronic pain, Fibromyalgia",,"Codieine, Diatrizoate, Hydrocodone, Dilaudid, Oxycodone","['Full blood count normal', 'Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Metabolic function test normal', 'Pyrexia']",1,MODERNA,IM 928342,GA,53.0,M,"Moderna COVID-19 Vaccine EUA Patient stated they had the following symptoms -Uncontrolled shaking, fever, Arrhythmia, dizziness, mental status change, nausea, skin reaction",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,,,,"['Arrhythmia', 'Dizziness', 'Mental status changes', 'Nausea', 'Pyrexia', 'Skin reaction', 'Tremor']",1,MODERNA,IM 928344,CO,79.0,M,"Pfizer-BioNTech COVID-19 Vaccine EUA: Within fifteen minutes of receiving vaccine patient experienced lightheadedness and dizziness. Remained awake alert and oriented and able to stand and ambulate. Initial vital signs were within normal rnage except blood pressure 152/67 mmHg. Patient denied chest pain, palpiatations, shortness of breath, difficulty breathing, nausea, vomiting, and pain. Patient stated they had not eaten yet that day and was immediately given juice, food, and water. One hour after vaccination patient stated symptoms were resolving. One hour and fifteen minutes after vaccination patient stated lightheadedness and dizziness returned and were slightly worse and developed a new symptom of ""ear and head pressure"". Repeat vital signs were within normal ranges except blood pressure was 139/92 mmHg. After discussion with healthcare provider decision made to transfer patient to urgent care/emergency department.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,PVT,"albuterol, apixaban, ascorbic acid, aspirin, atorvastatin, carvedilol, cyanocobalamin, diphenhydramine-acetaminophen, ezetimibe, ferrous sulfate, finasteride, fluticasone propionate, furosemide, ipratropium, irbesartan, omeprazole, tamsulos",none reported,"pacemaker, premature ventricular contractions, atrial fibrillation, cardiomyopathy, GERD, trochanteric bursitis, hip pain, low pack pain, sciatica, diabetes mellitus",,"meperidine, alkylamine antihistamines, cobalt, ethylenediamine, formaldehyde, gold sodium thiomalate, quaternium 15, zinc","['Dizziness', 'Ear discomfort', 'Head discomfort']",1,PFIZER\BIONTECH,IM 928346,MN,47.0,F,When injected noted sharp shooting pain up shoulder. Site was three fingers down and also above arm pit. Site confirmed by site contact as well. Ice applied,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Multivitamin, Red Rice Yeast, Vit D3, Sudafed daily",None,None,,Seafood,"['Injection site pain', 'Pain']",1,PFIZER\BIONTECH,IM 928347,IN,33.0,F,"Within a 5-8 minutes of receiving the vaccine, I became very dizzy and lightheaded. The nurse had me lay down and took my blood pressure. It was up to 145/94, unusual for me. I am normally under 120/80. I rested and had some water and orange juice. I felt weak but did not lose consiousness. After 30 minutes, my blood pressure was down to 131/87 and she thought it was okay for me to go home. On my drive home, the left side of my face/cheek was tingling. I still felt very weak but the dizziness had subsided. My fingers were also very cold. I laid down at home and around 6:45 PM, my cheek was still tingling, so I went back to the clinic. They sent me over to the ER. Everything came back normal, except my blood pressure was still elevated in the 140s/90s and the doctor stated I'd had a mild adverse reaction. When I got home, I went to bed. While I was in bed, I noticed my mouth area felt slightly numb. I went to bed and felt tired, but normal, in the morning. On 12/31/2020 and 1/1/2020 I experienced very bad arm pain that kept me up at night. I experienced a heaviness and throbbing sensation. It was very hard for me to move from side to side while laying down at night. During the day, the pain felt moderate, but at night was very severe. Over-the-counter pain medication helped some. The pain subsided after 2-3 days. One week after the vaccine, on 1/6/2021, I noticed pain at the injection sight again. On the night of 1/6/2021, the pain was severe again. I couldn't rotate from side to side without extreme pain and heaviness, and also felt the heaviness in my chest plate (not heart, but the bone of my chest). It kept me up most of the night. In the morning, the pain subsided to a mild pain. I applied heat and took ibuprofen the night of 1/7/2021 and noticed an improvement of pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,OTH,"fish oil, vitamin B-12 (600 mg), Vitamin D (1,000 iu), occasional usage of ibuprofen and/or acetaminophen",none,none,,some topical allergies to skin,"['Asthenia', 'Blood pressure increased', 'Chest discomfort', 'Dizziness', 'Fatigue', 'Hypoaesthesia oral', 'Injection site pain', 'Limb discomfort', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Peripheral coldness', 'Sleep disorder', 'Vaccination complication']",1,MODERNA,UN 928348,FL,74.0,F,"Chills, slight temperature, headache joint pain. Chills have continued off and on. Headache still present after9 hours, joint ache continues.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PHM,"Simvastatin, triampterine, baby aspirin, calcium with D3, Vit D3, B-16, Vit. C, iron, tart cherry extract.",None,"Arthritis, slight elevated cholesterol.",,None,"['Arthralgia', 'Chills', 'Headache', 'Pyrexia']",1,MODERNA,SYR 928349,OK,40.0,F,"Patient received dose #2 at 2:35 pm, at 2:45 pm onset of severe pruritis, shortness of breath with rapid onset of dyspnea. Epinephrine Injection, USP Auto-Injector 0.3 mg administered. Code blue called. This occured in hospital setting, emergency department responded to vaccination clinic. Oxygen therapy, Methlyprednisolone 125 mg IV push, Diphenhydramine 50 mg IV push.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Unknown.,No known.,Unknown diagnoses.,,"Latex, Penicillin, Shellfish","['Dyspnoea', 'Pruritus']",2,PFIZER\BIONTECH,IM 928351,,29.0,F,"Fatigue, headache, joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Arthralgia', 'Fatigue', 'Headache']",UNK,PFIZER\BIONTECH, 928352,AZ,30.0,F,"light headed, sore throat, swollen throat, body and muscle aches and fatigue, encouraged to seek medical attention.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Dizziness', 'Fatigue', 'Myalgia', 'Oropharyngeal pain', 'Pain', 'Pharyngeal swelling']",1,PFIZER\BIONTECH,IM 928353,MN,65.0,F,"On 12/31/20 at 2:00pm I developed a HA, with chills, & body aches. My right arm started to swell, redness from injection site approx. 6 inches very painful On Jan 1st temp 100.9 HA body aches and slept all day in bed. The redness in my arm finally went away on 1/7/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PUB,Propranolol for b/p,none,none,,none,"['Body temperature increased', 'Chills', 'Headache', 'Hypersomnia', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Pain']",UNK,MODERNA,IM 928354,TX,51.0,F,"Headache , Swollen at the injection site with Large welts, Throat tingling and swollen Hard to breath IV -Benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,Tramadol risperdal Citalopram Vitamin C Vitamin D Synthroid,,Lupus Rheumatoid arthritis,"Tetanus-Eyes swollen shut, hard to breathe",Tenics,"['Dyspnoea', 'Headache', 'Injection site swelling', 'Pharyngeal paraesthesia', 'Pharyngeal swelling', 'Urticaria']",1,MODERNA,IM 928355,TN,47.0,F,Day 9 same hot red injection site with the addition of two baseball size hot red swollen areas below then on day 10 they were softball size then on day 11 they are one huge hot red swollen area with a more blanched center and the injection site above is still red itchy and hot,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,Vitamin D3,None,None,,PCN FLAGYL MANGOS,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pallor']",1,MODERNA,SYR 928357,IN,35.0,F,chills started about6 1/2 hrs after shot extremely sleep about 8-9 hr after over all body aches started same time as chills all last right at 24 hrs,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,UNK,,,,,penicillin,"['Chills', 'Pain', 'Somnolence']",1,MODERNA,SYR 928358,WV,21.0,F,"Pfizer 1st dose- Not even five minutes after receiving the vaccine I started sweating, dizziness, headache, nausea and getting hives on both arms. They made my crew take me to the ER. When they took my vitals my O2 was 88% and they put me on 4lpm, HR was upper 110s and my BP was 160s/100s... The next day I couldn?t walk, keep my eyes open, had a headache, my whole body was aching and sore. I ended up sleeping for over 20 hours that day, couldn?t eat my husband had to actually help me walk to the shower and bathe me because I kept almost passing out.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Buspar Lexapro,N/a,"Asthma, anxiety, obesity",,Amoxicillin,"['Decreased appetite', 'Dizziness', 'Gait disturbance', 'Headache', 'Hyperhidrosis', 'Hypersomnia', 'Loss of personal independence in daily activities', 'Nausea', 'Pain', 'Urticaria']",1,PFIZER\BIONTECH,IM 928359,,29.0,F,"Fatigue, headache, joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Arthralgia', 'Fatigue', 'Headache']",UNK,PFIZER\BIONTECH, 928360,,29.0,M,Client complained of dizziness at 11:09. Will call for a ride home. Offered to call 911 (client refused) Suggested client go to ED. Client left to home in a LYFT; stated he has no other way home; instructed to go to the ED,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,,,History of adult Onset Stills Disease in remission 7 yrs per client.,,,['Dizziness'],1,MODERNA,UN 928361,IN,52.0,F,"Fever 101.5, aches, chills, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,Advil tylenol,None,None,,Sulfa,"['Chills', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928362,NJ,32.0,F,a swollen round raised bump as in a swollen lymph node on the the left side of the neck area. painful when I touch it. it appeared this morning.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/08/2021,4.0,PVT,,,,,sulfa,"['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 928363,NJ,44.0,M,"FEVER 102.1 , CHILL AND BODY PAIN FOR 28 HOURS. AFTER THAT NO SYMPTOMS AND FEELING BETTER, JUST TOOK TYLENOL 500MG THRICE A DAY.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,"I got my vaccine at 4 pm and I took my usual prescription meds at 8 pm after dinner ( metoprolol succinate 25mg, statin 10mg, Pepcid 10mg at bed time). I went to bed around 10:30pm and then at midnight I woke up with chill, feverish feeling","Sore throat, cough, congestion, seasonal allergies, heart burn","Pre diabetic, hypertensive BP, seasonal allergies.",,No known allergies.,"['Chills', 'Pain', 'Pyrexia']",UNK,MODERNA, 928364,IN,42.0,M,"Fever, chills, injection site pain, headache, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Vitamin C Zinc Flonase Claritin,,,Flu shot,Penicillin,"['Chills', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",UNK,MODERNA,SYR 928365,IN,39.0,F,"Edematous, red, itchy rash all over body. It started on my face and bilateral arms and then went to my neck, torso and legs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PUB,None,None,None,,None,"['Erythema', 'Oedema', 'Rash', 'Rash pruritic']",2,PFIZER\BIONTECH,IM 928366,MN,37.0,F,"EE reports that EE received 1st Covid-19 vaccine on 12/29/2020. EE report that later that evening EE began experiencing the following signs and symptoms of injection site pain, joint pain, headache, fatigue, and muscle pain. EE reports that EE was extremely fatigued on 12/30/2020 that EE was not able to work. EE called in to work on 12/30/2020. EE reports that EE has RTW work today, but is still experiencing the symptoms, but with improvement.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Fatigue', 'Headache', 'Impaired work ability', 'Injection site joint pain', 'Injection site pain', 'Myalgia']",1,PFIZER\BIONTECH,IM 928367,GA,65.0,F,"Tongue feels thick in back of throat. Denies respiratory distress, headache. Received Covid vaccine at 10:32. 11:18 Client continues to deny respiratory distress. States less feeling of thickness to tongue. Offered benadryl - client refused. 11:32 Client states she no longer has feeling of tongue thickness and is leaving to go home. Disposition: Stable upon leaving to go home; offered benadryl and refused benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,,Unknown,Unknown,,Unknown,['Tongue disorder'],1,MODERNA,IM 928368,,62.0,F,"chills, fever, muscle ache, joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Arthralgia', 'Chills', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 928369,FL,51.0,F,"Patient started experience burning in the eyes and bilateral tinnitus. She denied any rash, hives, swelling, facial edema, or pharyngeal edema, wheezing, shortness of breath, or chest pain. She was given Benadryl at the time and observed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Eye irritation', 'Tinnitus']",1,MODERNA,IM 928372,NC,57.0,F,"Fever 101.5, Chils, Rigors, Headache, body ache, much pain at site of injection Treated with tylenol, benadryl Next day at time of report, symptoms had not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Symbicort, Singular, Synthroid, Zoloft",None,asthma,,None,"['Chills', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928374,CT,21.0,F,"On 12/31/2020 I had a headache and I was tired. Over then next two days my arm was very sore. That subsided by 1/02/21. On 1/07/21 I woke up around 8 AM with my arm being sore again and at ejection site I had a red circle. The ejection site was also swollen. I took a benedryl and the pain subsided but the red circle continued to grow. On 1/08/21 the circle got even bigger (even with taking two 25 mg tablets of benedryl before bed) and it?s warm to the touch. Also on 1/07/2021 at around 6 pm I began menstrual spotting (this would be in the dead middle of my usual cycle). It continued into today ,1/08/2021. This is unusual for me as I have never experienced spotting in the middle of my cycle. Also on today 1/08/2021 my arm soreness has returned as the red circle is growing bigger around the ejection site (approximately 3 1/2 inches by 2 inches). I?m also experiencing extra tiredness and a headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,Birth control: drospirenone and ethinyl estradiol tablets 3mg/0.02mg,No,Occasionally anemic Summer of 2019 had mono very badly it effects my liver and I turned yellow for a few months. No long term effects from that besides what I think is a bad immune system.,,Sulfa Latex sensitive,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Menstrual disorder', 'Pain in extremity']",1,MODERNA,SYR 928375,AZ,35.0,F,"body aches hours after vaccine, rest, encouraged if needed to f/u with provider as needed",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,,,PVT,,,,,,['Pain'],1,PFIZER\BIONTECH,IM 928376,WI,40.0,F,"Pfizer-BioNTech COVID-19 Vaccine Approximately 24 hours after injection I felt dyspnea with minimal exertion and at rest while wearing my hospital mask, which I attributed to the cheap quality of the mask. Breathlessness was relieved after I took it off. I shoveled snow with no problem over the weekend, and was off work. Three days later, on 1/3 around 7 pm, I experience the same feeling while wearing the same type of mask, and it was relieve when I took it off. The following day, 1/4 around 2pm, while wearing a different disposable mask in the grocery store, felt extremely overheated and realized I was having difficulty breathing with minimal exertion. This time the feeling did not pass when I left the store/removed my mask, and residual effects of not being able to easily take a deep breath stayed with me the entire day. The feeling was gone in the morning, but did eventually re-occur the next day (tightness in my lungs not allowing for easy deep breaths) on 1/5 near the end of a shift where I had been wearing yet a different type of disposable mask. The symptoms starting around 4:30 pm and lasted throughout the rest of the evening. At this point I notified employee heath and scheduled a covid test. The next two days, on 1/6 and 1/7, the same type of dyspnea persisted throughout the day; while at rest, not relieved, and with no other symptoms (no cough, fever, etc.) Ibuprofen appears to relieve the discomfort, and I have returned to work, however the symptoms are still present if I am not taking Ibuprofen. Possibly some kind of pleurisy. My lung sounds are clear.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,"Reclipsen daily, L-Arginine 200 mg TID, Vitamin E 400 units daily , probiotic daily, prenatal vitamin daily",none,none,,none,"['Chest discomfort', 'Discomfort', 'Dyspnoea', 'Feeling hot', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 928377,IA,29.0,F,"Well at injection site, swollen arm around injection site, nausea, fatigue. Resolved on 01/08/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,UNK,Norethindrone Albuterol inhaler,,Asthma,,Beauty products,"['Fatigue', 'Injection site swelling', 'Nausea']",1,PFIZER\BIONTECH,SYR 928378,FL,95.0,F,"Congestion Shortness of breath Tachycardia Transferred out 911. Per hospital, patient had a myocardial infarction, is unresponsive, and on hospice services.",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/06/2021,01/07/2021,1.0,SEN,On: Norvasc 5mg daily Losartan 50mg daily Menest 0.3mg daily Vitamin C 500mg twice a day,,HX of CHF Pneumonia HTN Cardiac Murmur Osteoarthritis,,"Vasotec, Zocor, and Cymbalta","['Dyspnoea', 'Hospice care', 'Myocardial infarction', 'Respiratory tract congestion', 'Tachycardia', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 928379,IN,38.0,F,"1150 Post injection my tongue started to feel numb and tingling. Tongue started to swell. Over the next 20 minutes the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue, up my cheeks, and underneath my eyes on both sides. Because it kept slowly progressing I took 25 mg oral Benadryl. About 20 minutes after the Benadryl I noticed that my tongue didn?t feel or look as swollen. Within an hour I would say 95% better. I just had some trace numbness on my cheeks bilaterally. Symptoms returned again about 12 hours later. Again took Benadryl, this time 50 mg. All symptoms have resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,OTH,Adderall Effexor XR,None,Narcolepsy with cataplexy,,Naproxen Erythromycin,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia oral', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 928380,,81.0,M,"Patient received two doses of the COVID-19 vaccines. 1st on 12/18/20 and second one on 1/5/2021., On 1/6/2021, he tested positive for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 928382,IN,34.0,F,"Body aches, fatigue,fever Tylenol to treat Resolved in 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,UNK,None,None,None,,None,"['Fatigue', 'Pain', 'Pyrexia']",1,MODERNA,IM 928383,MA,28.0,F,Soreness in affected arm Fatigue Nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,Spironolctone Multivitamin Nortrel birth control Apple cider pills,N/a,N/a,,Metrogel,"['Fatigue', 'Nausea', 'Pain in extremity']",1,MODERNA,IM 928384,CA,52.0,M,Developed an itchy rash over left anticubital area.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/17/2020,1.0,PVT,Vitamins,None,,,None,"['Rash', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 928385,IA,35.0,F,"Fever, body aches, chills, diarrhea, joint swelling, leg swelling, skin tenderness, extreme joint pain, nausea, upper back and neck pain, headache, skin redness not at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,40mg fluoxetine 81mg aspirin,None,"Depression, ADD",,None,"['Arthralgia', 'Back pain', 'Chills', 'Diarrhoea', 'Erythema', 'Fibrin D dimer normal', 'Headache', 'Joint swelling', 'Metabolic function test normal', 'Nausea', 'Neck pain', 'Pain', 'Pain of skin', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 928386,OH,59.0,F,5 days after vaccine swollen lymph node and swollen neck near collar bone. 7 days after vaccine red swollen itchy at injection site. No signs prior to that except soreness at injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PUB,"Biotin 500 mg, Tofrinil 50 mg, Ativan .5 mg, Atenolol 25 mg",none,Elevated Heart Rate,,Morphine,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Lymphadenopathy', 'Swelling']",1,MODERNA,IM 928387,ME,45.0,F,"headache, chills, body aches and generalized unwell feeling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,zoloft,none,none,,hazelnuts,"['Chills', 'Headache', 'Malaise', 'Pain']",2,PFIZER\BIONTECH,IM 928389,IA,58.0,F,"Severe Body pain, temp, nausea and vomiting, Severe Headache - described as ""48 hrs of the worst pain I have ever endured.""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"Benicar, Previstatin, Wellbutrin, Jardianace",None,Diabetes and High Blood Pressure,Onsite itching from flu shot,Sulfa meds and Phenergan,"['Body temperature increased', 'Headache', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,IM 928390,DE,92.0,F,1/3/2021 developed facial drooping later to be diagnosed by ER on 1/4/2021 as Bels Palsy status post COVID-19 Vaccine administered on 12/28/2020. The long-term outcome is unknown. The patient returned to the center and was doing well.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/03/2021,6.0,SEN,,,,,,"[""Bell's palsy"", 'Facial paralysis']",1,PFIZER\BIONTECH,IM 928391,VA,35.0,M,"About a week later I noticed itchiness at site of injection. The next day a red welt had appeared around injection site and was hot to the touch. I applied ice and took an Aleve PM as it was time for bed. Next morning I wake up for work and redness has subsided some and is no longer as hot. I still reported it to my manager and Lab Director, who also reported it to the Pharmacy dept and advised me to report it here.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/07/2021,9.0,PVT,"Multivitamins, fish oil, garlic",None,None,,Nickel,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth', 'Urticaria']",1,MODERNA,IM 928392,TX,71.0,F,"One week after injection, injection site became inflamed, warm to touch and large rash surrounding the injection. Slight fever of 99",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,OTH,"Sertraline 50 mg, multi vitamin, calcium, vitamin d, levothyroxine 25 mcg, , stool softner",none,none,,None,"['Injection site inflammation', 'Injection site rash', 'Injection site warmth', 'Pyrexia']",1,MODERNA,IM 928393,,44.0,M,"fever, flu symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Influenza', 'Pyrexia']",UNK,PFIZER\BIONTECH, 928394,CA,32.0,F,"Recieved 2nd dose of COVID-19 vaccine at 7:56am. Walked back to clinic . Around 0900 started feeling throat tightening and throat itching, reports bilat hand felt numb. Walked back to vaccine clinic with co-worker . Reports ALG to Amoxicillin=rash/throat swelling. Employee A/O x 4, color pink, no difficulty breathing, tongue not swollen, but anxious. Moved to Employee Health Services (EHS) for observation are via w/c. Given 50 mg of po Benadryl. VS and pulse ox monitored. V/S and O2sat remained with normal limits. At 11:00am, Employee reported the her throat swelling and itchiness had resolved. D/C home, escorted by husband (HCW). Follow-up call made by health care provider at 17:36pm, employee reported her symptoms had resolved and she took a long nap.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,UNK,,,,,Amoxicillin,"['Anxiety', 'Somnolence', 'Throat irritation', 'Throat tightness']",2,PFIZER\BIONTECH,IM 928395,MA,25.0,F,"Nausea immediately following injection that continued for 24 hours, Stoke like symptoms that began six hours after injection that persist currently (48 hours +) including severe headache (resolved after 24 hours with 800mg ibuprofen Q3, Benadryl 25mg Q3 ), confusion, cognitive impairment, vision changes (L), drift in the upper extremity (L), dizziness, lack of coordination, and difficulty with depth perception. Neck stiffness from 12 hours post injection to 48 hours post injection. Negative for fever, vomiting, hemiparesis, difficulty with speech or word finding, facial droop,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,"lo loestrin fe, Cetirizine",,Celiac disease,"gardasil, age 12, Syncope post injection","sulfa, gluten containing products, latex","['Altered visual depth perception', 'Cognitive disorder', 'Confusional state', 'Coordination abnormal', 'Dizziness', 'Headache', 'Immediate post-injection reaction', 'Musculoskeletal stiffness', 'Nausea', 'Neurological symptom', 'Upper motor neurone lesion', 'Visual impairment']",1,MODERNA,IM 928396,WA,38.0,M,Starting the morning of Jan 8th I became moderately body sore and tired. I have bouts of being slightly nauseous. The injection site is very tender.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,None,None,None,,None,"['Fatigue', 'Injection site pain', 'Nausea', 'Pain']",1,MODERNA,SYR 928398,FL,29.0,F,"Onset Headache, Body Aches, Chills, Fatigue 10 hours after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,,,,None,"['Chills', 'Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 928399,OH,46.0,F,"About 1 week after, pt had localized reaction of redness, swelling and tenderness. After two days started to decrease .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,PVT,None,none,Osteoporosis,,NKDA,"['Erythema', 'Skin reaction', 'Swelling', 'Tenderness']",1,MODERNA,IM 928400,IA,58.0,F,"Severe reaction to the Covid Vaccine Severe Body pain, temp, nausea and vomiting, Severe Headache48 hrs of the worst pain I have ever endured.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"Benicar, Wellbutrin, Jardiance, Prevastatin",None,Diabetes and high blood pressure,Flu shot - itchiness at injection site,Sulfa Meds and Phenergan,"['Body temperature increased', 'Headache', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,IM 928401,GA,57.0,F,"Patient has seronegative spondyloarthropathy auto immune condition. Has not had any issues in a while. A few days after receiving the Moderna vaccine, developed some mild arthritic symptoms in R hand, R hip and sternum and eventually the right side of neck going up into skull area. Pt developed a fever blister under nose. Pt did not have a fever. In addition to the voltaren patient takes daily, added some ibuprofen. Symptoms are improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/02/2021,3.0,PVT,,,,,,"['Arthritis', 'Oral herpes']",1,MODERNA,IM 928402,PA,36.0,M,"chills, rigors, fatigue, temp 101.8",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,OTH,,,,,,"['Body temperature increased', 'Chills', 'Fatigue']",2,PFIZER\BIONTECH,SYR 928403,MI,30.0,F,"Fever, chills, muscle and joint pain, headache; improved with ibuprofen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 928404,MI,28.0,F,Chills and 99.7� fever 26 hours after injection. Very painful arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,"Multivitamin, omega 3 Fatty Acid (algae based), turmeric supplement",None,None,,Erythromycin,"['Chills', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 928405,VA,35.0,F,Hard knot/muscle stiffness at injection site 8 days after receiving dose. Itching and pain lasting approximately 2 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,UNK,"Biotin, Vitamin D, Allegra",None,None,,None,"['Injection site mass', 'Musculoskeletal stiffness', 'Pain', 'Pruritus']",1,MODERNA,SYR 928406,MO,56.0,M,"Arm redness, swelling. Developed 7d after vaccination and appearance consistent with cellulitis.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/08/2021,7.0,UNK,"Lisinopril/HCTZ, Atorvastatin, Nexium.",,"HTN, Hyperlipidemia",,NKDA,"['Cellulitis', 'Erythema', 'Peripheral swelling']",1,MODERNA,IM 928407,,61.0,F,Delayed onset of injection site reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/07/2021,10.0,PVT,,,,,,['Injection site reaction'],1,MODERNA,IM 928408,MI,61.0,F,"1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after receiving the vaccine, at 2 PM started with itching of scalp, arms, legs, rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck. Took 50 mg Benadryl w/ some relief. 630 PM symptoms reoccur, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER at 830 PM",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,PVT,"Omeprazole , atorvastatin - RX meds Over the counter med- Zyrtec Dietary Supplements - Fish Oil, Calcium with Magnesium and Zinc, Vitamin D 3, CoQ10",none,none,,allergic to Sulfa and Cipro,"['Discomfort', 'Dysphagia', 'Fatigue', 'Injection site pain', 'Pruritus', 'Rash pruritic', 'Swelling', 'Swelling face', 'Urticaria']",1,PFIZER\BIONTECH,IM 928409,NJ,59.0,F,"Mild soreness at right armpit noted on day 5 or 6 post vaccine administration. Day 7 noted right upper arm swelling, redness, firmness warmth. Day 8 redness swelling and warmth increased w odd sensations locally. Intermittent chills no fever. Apt w PCP to evaluate diag cellulitis. ATB odered. Doxycycline 100 mg 2x day for 7 day",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,OTH,"Vit C, Vit D, MVI. As needed Ibuprofen",none,none,,Cefzil,"['Axillary pain', 'Chills', 'Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site warmth', 'Sensory disturbance']",1,MODERNA,IM 928410,,31.0,F,"fever, chills, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Chills', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 928411,ME,50.0,F,"Localized injection site reaction on day 6, including itch and burning pain, cellulitis appearing reaction, redness, hardness developed on day 7, redness continuing on day 8, 9, 10 with soreness, itching and arm pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,WRK,Pepcid,no,no,,None known,"['Injection site cellulitis', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Pain', 'Pain in extremity']",1,MODERNA,IM 928412,CO,39.0,F,"Fever, body aches, chills, nausea and vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 928413,TX,31.0,M,"Pt report fever of 100.6, left shoulder blade pain and swelling of the left arm pit. Treatment include Tylenol will continue to monitor.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Arthralgia', 'Oedema peripheral', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928414,OH,33.0,F,"Headache, nausea, body aches, fever 103f, severe rigors unrelieved by Tylenol and Motrin for 6 hours the night of the injection. Continued low grade fevers (100.4-100.8) and malaise, nausea, headache for the next two days. And sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Tylenol,24 hour GI flu 2 weeks prior (rapid covid negative),None,,None,"['Chills', 'Headache', 'Malaise', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 928416,IN,54.0,M,"Body aches began about 11-12 hours after dose and continued for about 40 hours after dose. Severe chills began about 4:00 am, 19 hours after dose and lasted several hours. Chills returned two to three times over the next 20 hours. Low-grade fever began about 8:00 am, 23 hours after dose. Fever peaked to 101.2 F about 36 hours after dose. All symptoms resolved within 48 hours after dose. Fever and pain were reduced with use of acetaminophen. Two doses of 1000mg taken. One around 9:00 am on 1/6/21 and another around 9:00 pm on 1/6/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"famotidine, cetirizine, hydrochlorothiazide, multivit, vit c",,"hypertension, migraines, irritable bowel syndr., allergic rhinitis, obesity","Shingrix first dose. Bodyaches, fever, diarrhea, headache, nausea. Age 54",cephalexin,"['Chills', 'Pain', 'Pyrexia']",1,MODERNA,IM 928417,MN,39.0,F,"Vaccine was given above deltoid area, given in shoulder area. Right shoulder started to swell. Pain in right arm starting in shoulder and runs down the entire arm. Pain continues 1 week after receiving the injection. Mild swelling continues in right shoulder. Having numbness in right hand.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/24/2020,0.0,WRK,Unknown,Unknown,Unknown,,Unknown,"['Hypoaesthesia', 'Injection site pain', 'Injection site swelling', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 928418,NY,31.0,F,"On day 8 post vaccination the injection site became rapidly inflamed, hot to touch, itchy, swollen, tender. Unsure if injection site reaction versus cellulitis.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,WRK,"Vitamin b12, vitamin d3, dha omega 3",None,Ptsd,,"Clindamycin, walnuts, pecans","['Injection site inflammation', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 928419,,37.0,F,Swelling at the injection site Hot to touch at fever site Hardness at injection site Redness at injection site On ongoing and worsening for over a week Started Benadryl yesterday,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,WRK,Liquid multi vitamin Liquid zinc Liquid vitamin c Birth control ( levonorgestrel & ethinyl estradiol tablet),N/a,N/a,,N/a,"['Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site warmth']",1,MODERNA, 928420,MT,24.0,F,Tested COVID + on 01/04/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/04/2021,6.0,PUB,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,MODERNA, 928421,AR,45.0,F,"On 12-16-2020 I received my first Pfizer injection and 5 days after I experienced lymphadenopathy to my neck, left arm and under the arm and clavicle. My lymph nodes are swelling and I am concerned since I never had my lymph nodes swell up. On my second injection 01-06-2021, I continue with lymph node swelling and my symptoms do not seem to go away. I went to see my doctor, that said it was probably a reaction to the Pfizer injection and he is recommending that in February 2021, if I still have swelling to my lymph nodes then lab work will be performed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/22/2020,6.0,PVT,None reported,None reported,None reported,,Shellfish,['Lymphadenopathy'],2,PFIZER\BIONTECH,IM 928422,IN,48.0,F,"High fever ongoing 16 hours now. Headache, shaking, muscle pain, vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Headache', 'Myalgia', 'Pyrexia', 'Tremor', 'Vomiting']",1,MODERNA,IM 928423,CA,35.0,F,Dizzy Headache Nausea Body Ache Chills Brain Fog,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,"['Chills', 'Dizziness', 'Feeling abnormal', 'Headache', 'Nausea', 'Pain']",1,MODERNA,SYR 928424,KY,40.0,F,"Severe headache about 12 hours , severe nausea 18 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Biotin Zoloft Zyrtec Wellbutrin Spirinolactone Linzess Miralax,None,Asthma,,Latex,"['Headache', 'Nausea']",1,PFIZER\BIONTECH,SYR 928425,,46.0,F,"Employee began experiencing pain and decreased ROM in shoulder hours after injection. She was evaluated by ortho, and IR was determined that injection was placed too high and went into her bursa.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,UNK,,,,,,"['Injection site pain', 'Joint range of motion decreased', 'Product administered at inappropriate site']",UNK,MODERNA, 928426,WI,63.0,F,"fever, muscle aches,headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"atorovastin,Bupropion,Fluoxitine,Protonix,Lantus,Iron,Ocuvitr,Multivitamins,Montulukast Metformin,Lisinopril,Ozempic,Vit d",none,"Asthma, Hypertension,Type 2 Diabetic,Hypothroid",,Sulfa,"['Headache', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 928427,NC,59.0,F,"Arm Pain, Swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/01/2021,9.0,PVT,,,,,,"['Pain in extremity', 'Swelling']",1,MODERNA,IM 928428,,44.0,M,"Posterior headache, nape and upper back pain Low grade fever for about 18 hrs Armpit tenderness on the side of injection",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Axillary pain', 'Back pain', 'Headache', 'Injection site pain', 'Neck pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928429,CT,59.0,F,fever-low grade starting 8 hrs after injection lasting 36 hrs-99.3-100.5 bilateral axillary tenderness lymph node swelling bilaterally-neck lasting 36 hrs mild headache eye swelling/itch all symptoms relieved with Benadryl 50-75mg x2 doses and Tylenol 500mgx2,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,HCTZ,none,HBP/seasonal allergies/asthma activity induced,,bees/spiders/wasp stings-emycin and sulfa drugs,"['Eye pruritus', 'Eye swelling', 'Headache', 'Lymphadenopathy', 'Pain of skin', 'Pyrexia']",1,MODERNA,IM 928430,MA,62.0,F,"body aches, low grad temp, nausea that led to one episode of dry heave vomiting, weakness & fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,New Chapter 55+ every woman's one daily multi New Chapter Plant Calcium Bone Strength Nordic Naturals Ultimate Omega + CoQ10,none,Hashimotos thyroiditis osteoporosis,,neosporin/neomycin/garamycin/erythromycin/sulfa; rash alcohol/general anesthesia; very nauseous and sick feeling alendronate: gi upset denosumab: back of throat numbness,"['Asthenia', 'Fatigue', 'Nausea', 'Pain', 'Pyrexia', 'Retching', 'Vomiting']",2,PFIZER\BIONTECH,IM 928431,MI,34.0,F,Numbness and tingling over entire body. Settled to left side. Still present 9 days post vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,None known,None,Multiple Sclerosis,,None known,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 928432,PA,59.0,F,From Patient: I received my shot on 12/30/20. When I got to my car I was having some face numbness and tingling. I went back to work I also had some weakness and being tired but that went away and weakness in my legs but that went away didn?t last long. The numbness and tingling in my face and neck did not go away. My arm is still sore. I did go to the er last night cause my blood pressure was high at home and face still numb and tingling. Just thought I better check things out. Dr wasn?t sure if it was a reaction from the covid shot he was checking for stroke issues all tests he ran were good.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Blood pressure increased', 'Hypoaesthesia', 'Pain in extremity', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 928433,MT,70.0,M,Moderna COVID-19 Vaccine EUA. Welts and itching on left arm started Jan 7 in the evening. This started either at or very close to the injection site. By the morning of the 8th the area was no longer itching but there was a red rash still visible.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,PVT,Aspirin 82mg once per day Iron 65mg once per day Fomatidine and Omeprazole as need Acetaminophin as needed,None,Minor high blood pressure *average 130/80) - constantly monitored but not currently being treated,,Allergic reaction to contrast used in CAT scans. Two instances - hives only. Pretreated before second instance.,"['Pruritus', 'Rash erythematous', 'Urticaria']",UNK,MODERNA,IM 928438,OK,,U,"vision loss; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 01-JUN-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation), the pt was treated by a physician for vision loss (blindness) and other zoster-related conditions (ill-defined disorder). On an unknown date, he was admitted to the hospital due to the events. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of this report, the outcome of blindness and ill-defined disorder was unknown. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, blindness was considered a medically significant event.",Not Reported,,Not Reported,Yes,,Not Reported,U,06/01/2014,,,PHM,,,,,,['Blindness'],UNK,MERCK & CO. INC.,OT 928441,SC,73.0,F,"Guillain Barre syndrome; Syncopal episode; Acute inflammatory demyelinating polyneuropathy (AIDP); GASTROPARESIS; Insomnia; Poor short-term memory; Spinal stenosis in cervical region; polyneuropathy; Numbness; weakness; Chest pain; Lower extremity pain/bilateral leg pain; Malignant tumor of breast; Lightheadedness; Muscle weakness; Fatigue; This case was reported by a lawyer and described the occurrence of demyelinating polyneuropathy in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced demyelinating polyneuropathy (serious criteria GSK medically significant) and guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the demyelinating polyneuropathy and guillain barre syndrome were unknown. It was unknown if the reporter considered the demyelinating polyneuropathy and guillain barre syndrome to be related to Shingrix. The initial information received on 10 December 2020, via medical records. As per records, she was alcohol user for 2 to 4 times a month. As per records, she had history of orthostatic hypotension, gastroparesis, retention of urine, unspecified. As per records, he had concurrent 28 April 2019, of spinal stenosis in cervical region, Microscopic colitis, Essential hypertension, dyslipidemia and hypothyroidism. As per records, the female patient received shingles vaccine in 2012. As per records, on 12 September 2019, she had Shingrix (PF) 0.5 ml intramuscular suspension. On 25 November 2019, she had Cobalamin deficiency, muscle weakness, lightheadedness, fatigue, acute inflammatory demyelinating polyneuropathy, In October 2019, she was hospitalized. On 06 January 2020, she was hospitalized for Guillen Barre and chronic diarrhea. On 07 January 2019, breast cancer screening. As per records dated 30 April 2020, she had malignant neoplasm of nipple and areola, left female breast. She also had dyslipidemia, acute inflammatory demyelinating polyneuropathy, cobalamin deficiency. As per records dated 13 February 2020, she had adult hypothyroidism, bilateral renal artery stenosis, Chest pain, chronic pain of lower extremity, dyspnea on exertion, lipedemia, lower extremity pain, syncope, Guilliain-barre syndrome onset date 21 November 2019. As per records, she had gotten the shingles vaccination in September 2019, and developed symptoms of bilateral leg pain and then had a syncopal episode. She was then admitted to the hospital. As per records dated 21 September 2020, she had Guillain-Barre syndrome a year ago. She was hospitalized and in rehab for an extensive amount of time. It thought that might have occurred after her shingles vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,U,09/12/2019,11/25/2019,74.0,UNK,,Alcohol use (2 to 4 times a month); Colitis microscopic; Dyslipidemia; Essential hypertension; Hypothyroidism; Nonsmoker; Spinal stenosis in cervical region,,,,"['Chest pain', 'Demyelinating polyneuropathy', 'Diarrhoea', 'Dizziness', 'Dyslipidaemia', 'Dyspnoea exertional', 'Fatigue', 'Guillain-Barre syndrome', 'Hypothyroidism', 'Lipoedema', 'Malignant nipple neoplasm female', 'Muscular weakness', 'Pain', 'Pain in extremity', 'Renal artery stenosis', 'Syncope', 'Vitamin B12 deficiency']",UNK,GLAXOSMITHKLINE BIOLOGICALS,IM 928447,NC,,M,"patient has Diabetes; High Cholesterol; Thyroid problems; received 1st dose of Engerix B in 2010 and did not complete the series yet; This case was reported by a pharmacist via call center representative and described the occurrence of diabetes in a adult male patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. On an unknown date, the patient received the 1st dose of Engerix B and the 2nd dose of Engerix B. On an unknown date, more than 2 years after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced diabetes (serious criteria GSK medically significant), blood cholesterol increased, thyroid disorder and incomplete course of vaccination. On an unknown date, the outcome of the diabetes, blood cholesterol increased, thyroid disorder and incomplete course of vaccination were unknown. It was unknown if the reporter considered the diabetes, blood cholesterol increased and thyroid disorder to be related to Engerix B. Additional details were reported as follows: The age at vaccination was not reported. The patient received the 1st dose of Engerix B in 2010. The reporter stated that the patient had diabetes, thyroid problems and high cholesterol but was not aware if these conditions were prior to dose 1 of Engerix B. The reporter consented to follow up. All patient identifiers were reported, no batch number or expiration date reported when asked. The patient received the 1st dose in 2020 and did not complete the series till the time of reporting which led to incomplete course of vaccination. The reporter asked should they have to revaccinate or administering 2nd and 3rd dose would be ok.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Blood cholesterol increased', 'Diabetes mellitus', 'Incomplete course of vaccination', 'Thyroid disorder']",2,GLAXOSMITHKLINE BIOLOGICALS, 928448,,68.0,F,"Pain is so bad / had an episode of passing out; Severe pain behind her right knee; Severe pain / left bicep; Unable to walk without a walker; Swelling behind her right knee; This case was reported by a consumer via call center representative and described the occurrence of passed out in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 4th November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In November 2020, less than a week after receiving Shingrix, the patient experienced passed out (serious criteria hospitalization and GSK medically significant), knee pain (serious criteria hospitalization), muscle pain (serious criteria hospitalization), unable to walk (serious criteria hospitalization) and swelling of knees (serious criteria hospitalization). On 4th January 2021, the outcome of the knee pain, muscle pain and unable to walk were recovered/resolved. On an unknown date, the outcome of the passed out was recovered/resolved and the outcome of the swelling of knees was unknown. It was unknown if the reporter considered the passed out, knee pain, muscle pain, unable to walk and swelling of knees to be related to Shingrix. Additional details were reported as follows: The case is reported by husband of patient. He stated that his wife received the second dose of Shingrix and about 3 to 4 days later, she began to experience severe pain behind her right knee and left bicep. She also had swelling behind her right knee. The pain was so bad, she had an episode of passing out. She went to the emergency room and was kept overnight for observation and then discharged. She was unable to walk without a walker. Provided medical disclaimer and advised to follow up with his wife's health care professional. The reporter did not consent to follow-up. Note: Reaction end date is given for pain and swelling behind right knee and pain in left bicep but outcome given as not recovered. Captured outcome as recovered as reaction end date is given. Discrepant information reported in XML and narrative for onset date of events. Events onset date captured as per narrative.",Not Reported,,Not Reported,Yes,,Not Reported,Y,11/04/2020,11/01/2020,,UNK,,,,,,"['Arthralgia', 'Gait inability', 'Injection site pain', 'Joint swelling', 'Loss of consciousness', 'Myalgia', 'Walking aid user']",2,GLAXOSMITHKLINE BIOLOGICALS,IM 928449,IN,31.0,F,Redness around injection site the day after. Swelling like a lump or knot under skin and pain increase second day. Third day itchy skin at injection site but less pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,OTH,"Pantoprazole, Klonapin, Tri-Sprintec, Viibryd, Wellbeing, ibuprofen",None,"Migraines, IBS, Anxiety, depression",,None known,"['Injection site erythema', 'Injection site pruritus', 'Mass', 'Pain', 'Swelling']",UNK,MODERNA,IM 928450,,58.0,M,"Received a COVID-19 vaccination in his left arm and 9:15 on 12/182020 and states that he felt some swelling sensation in his throat. He received 25 mg of Benadryl there initially and then a few minutes later got another 25. He had no chest pain or shortness of breath. He had no difficulty swallowing. He has had somewhat of a similar reaction in the past when he is exposed to cat hair. He was sent to ED by EMS for further evaluation. No rash. Arrived 10:16am, given pepcid, declined steroids and discharged at 11:47am. Felt normal within 2-3 hrs after receiving the vaccine. Given EpiPen for second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/18/2020,0.0,UNK,,,,,,['Pharyngeal swelling'],1,PFIZER\BIONTECH,IM 928451,NC,46.0,F,"Shoulder, Trapezius pain..severe. Severe headache. All occurring days afterwards",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/04/2021,4.0,PVT,,,,,,"['Arthralgia', 'Back pain', 'Headache']",UNK,MODERNA,IM 928452,AZ,37.0,F,"-on 1/6/21 my right arm started feeling sore -on 1/7/21 when I woke up in the morning I was very cold for four hours. My feet remained cold the entire day. I also woke up with a headache which lasted all day. In the late afternoon my body started aching which lasted all night. On my right arm well below the injection site my skin pigmentation changed; there is a patch of skin which is now lighter. -on 1/8/21 my head still hurts, my neck area feels very sore. I still have the skin color change on my arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,allegra womens daily vitamin magnesium retin-A,none,none,,allergic to PCN and Sulfa,"['Feeling cold', 'Headache', 'Neck pain', 'Pain', 'Pain in extremity', 'Peripheral coldness', 'Skin discolouration']",1,MODERNA,SYR 928453,TX,46.0,U,"Approximately 1 hour after receiving dose #1 of Moderna COVID vaccine, I was sitting at work desk and suddenly felt flushed/hot throughout body; told nearby co-workers I felt light-headed; nearby co-workers then noticed I became quiet, sat and stared into space for about a 30 second timespan while sitting at desk; Co-workers then noticed I was confused and seemed to lose a span of time; Co-workers assisted me to lay down and made suggestion to go to ED. I refused to go to ED and continued to be confused for about 15 mins. Patient returned to baseline state and did not recall the events; I then agreed to go to ED; Co-workers wheeled me to ED where an EKG was done and released after an hour of observation.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,"Zoloft, Iron, Vyvanse",none,none,,none,"['Confusional state', 'Dissociative amnesia', 'Dizziness', 'Electrocardiogram', 'Feeling hot', 'Flushing', 'Social avoidant behaviour', 'Staring']",1,MODERNA,SYR 928454,OK,93.0,M,DIZZINESS,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,SEN,NORVASC PLAVIX DEPAKOTE SPRINKLES COLACE ARICEPT CYMBALTA LASIX NAMENDA PRILOSEC FLOMAX TYLENOL MOM POLYETH GLYC POW,NONE,COPD,,CODEINE,['Dizziness'],1,PFIZER\BIONTECH,IM 928455,,42.0,F,Started with hives approximately 15 minutes after and then went into full Anaphylaxis. Required epi and Benadryl.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,WRK,,,,,,"['Anaphylactic reaction', 'Urticaria']",2,PFIZER\BIONTECH,IM 928456,ID,28.0,F,"Fever, chills, flu like symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Chills', 'Influenza like illness', 'Pyrexia']",1,MODERNA,IM 928458,PR,40.0,M,"Nausea and dry heave, diarrhea once, epigastric pain. 18 hours post injection. Treated with Maalox 60 ml single dose. Symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,MIL,omeprazole 20mg once a day,none,"Chronic smoker, hearing impaired",,"shellfish - angioedema, does not carry an epipen","['Abdominal pain upper', 'Diarrhoea', 'Nausea', 'Retching']",1,MODERNA,IM 928459,NJ,31.0,M,"1. Pulsing pain at dose administration site at 11 pm. -No treatment, went to sleep. 2. (12 hrs after administration). Woke up at 1:00 am with severe chills. Lasted 2 hours. -Threw on sweats and another blanket, went back to sleep. 3. Woke up at 6:30 am with intense body and head pain. ""was a cant get comfortable in any position type of pulsing pain"" Something im accustomed to when i get the Flu. I rolled around in pain for 4 hours while trying to go back to sleep; it even hurt to breathe deeply. - took Tylenol at 11am and the symptoms never came back. *Note. I think i suffered so much pain in the 4 hours that it lasted with me until even now as i write this. Hard to describe, but my entire body has had this tiny ache that has not gone away. Not a big deal to me, but just wanted it documented. I am selecting recovered even with that tiny ache still apparent because physical pain usually takes time to heal. Assuming that's all it is.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,none,none,none,,none,"['Chills', 'Headache', 'Injection site pain', 'Pain', 'Painful respiration']",1,PFIZER\BIONTECH, 928460,OH,58.0,F,"Injection given in Left Deltoid. No complaints at this time of injection. Arrived in waiting area at 0725. At 0750 C/o feeling warm, skin clammy, alert and oriented x 3. Felt like a hot flash. BP 141/75, P=74. At 0754A states feeling much better, skin warm, dry. BP 139/69, P=67 At 0757 Patient chatting, alert and oriented x 3, skin warm, dry BP 169/93, P = 76. patient left observation room with husband who drove her home",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Blomplexi, Buproprion, Calcium, Vit B-12, Biotin, MVI, Protonix, Zoloft, Diovan HCT",none,none,,Lisinopril,"['Cold sweat', 'Feeling hot']",1,MODERNA,IM 928461,FL,67.0,M,"Anaphylactic reaction, Severe edema and raised red rash entire body, Severe itching ,Soft tissue edema of throat. Swelling of, eyes, lips, face. Multiple trips to ER, treated with steroids, Benadryl, prevacid. , CURRENTLY IN ICU ON EPINEPHRINE DRIP, STEROIDS, MULTIPLE MEDS",Not Reported,,Yes,Yes,5.0,Not Reported,N,12/29/2020,01/03/2021,5.0,PVT,"Metformin, Lisinopril, Simvastatin, Ozempic , pantopazol",none,Diabetes,,Cephlasporin,"['Anaphylactic reaction', 'Computerised tomogram abnormal', 'Eye swelling', 'Intensive care', 'Laboratory test', 'Lip swelling', 'Oedema', 'Pharyngeal oedema', 'Pruritus', 'Rash', 'Rash erythematous', 'Rash papular', 'Swelling face']",1,MODERNA,IM 928462,CT,64.0,F,"Hot , raised, itchy rash below injection site on Left Arm resembling cellulitis",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,"Citalpram, Amlodipine, Pravastatin, Vitamin D ,Multivitamin. B Complex, Magnesium",none,"Hypertension, Wolf- Parkinson White Syndrome, Anxiety",,none,"['Injection site cellulitis', 'Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Rash pruritic']",1,MODERNA,IM 928463,MN,43.0,F,"I had pretty severe symptoms about 12 hours after the vaccine. I received the vaccine on 1/6 at 8 am. Serve headache, body aches, chill, fever. They lasted about 12 hours and then most of today just overall fatigue. I now have discomfort in my back and chest. Is this normal?",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Chest discomfort', 'Fatigue', 'Headache', 'Musculoskeletal discomfort', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928464,RI,69.0,F,"Upon leaving observation, pt stated her lips felt ""tingly"". No edema present to site. Pt, recieved (2) Benadryl 25mg from this nurse to take w/ her. Pt was currently @ work, and did not want to take meds @ present time. Left observation @ 11.02.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,,,,,,['Paraesthesia oral'],2,PFIZER\BIONTECH,IM 928466,MT,69.0,F,Developed facial swelling. Diphenydramine administered.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,SEN,,,,,,['Swelling face'],UNK,MODERNA, 928467,TX,37.0,F,"Symptoms - ? EE reports beginning at approximately 19:00 (1/7) chills and myalgias. EE reports she tossed and turned last night so woke up feeling pretty tired. EE reports today she feels okay minus feeling a bit tired. EE denies fever, COVID-19 exposure without proper PPE and recent travel. Last day of work and shift - ? unknown Home remedies? - none Any improvement? - yes Recommendation? EE encouraged to continue to monitor her symptoms and to call vaccine support line with further questions/concerns. EE verbalized back understanding and denied further questions at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Chills', 'Fatigue', 'Myalgia', 'Poor quality sleep']",2,PFIZER\BIONTECH,IM 928469,TX,79.0,F,"It has been over a week. Early this week 1/5 I noticed continued mild pain, itching, redness and a keloid on left arm at site of injection. Very uncomfortable, especiall itchiness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PHM,"Calcium, D3, Zinc,Magnesium",None,Osteoporosis,,None known.,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Keloid scar']",1,MODERNA,IM 928470,TX,43.0,F,On day 2 evening the 5th I developed severe arm soreness. Could not lift or put pressure on it. That evening I developed fever that lasted a full day. On the 8th I have numbness and tingling on the same left arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,no,no,no,,no,"['Hypoaesthesia', 'Mobility decreased', 'Pain in extremity', 'Paraesthesia', 'Pyrexia', 'Tenderness']",1,MODERNA,IM 928471,OH,28.0,F,"1/8: 10:00- began to develop increased soreness and fatigue 14:00 began to develop fever, chills, headache, nausea l, muscle soreness, bone pain, fatigue onset and are consistently present.. Required to leave early secondary to symptoms. Tylenol administered 20:00 lip and facial edema noted to onset. Nausea and dry heaving onsets, feeling of malaise. Fever of 102.3. tylenol given 23:30 lip edema worsening. Pain worsening. Weakness onsets . Continued fever of 101.3. 50 mg of benadryl and pepcid administered 1/9 4:00 bone pain and chills improced. Continued fatigue, muscle aches, headache and nausea. lip edema not improved. Mild facial edema noted. Increased difficulty swallowing noted and dry heaving continues. Care sought in ED. IV decadron and benadryl administered 6:30 discharged from ED with zyrtec, prednisone taper and pepcid scripts. Countinued home monitoring 11:00 lip edema stable. Fever improved. Fatigue, soreness, headache continue to be present, but improved",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Birth control,COVID 19 diagnosed 12/15/20- all symptoms resolved,Asthma- no issues in the past 5 years,,History of amoxicillin mono rash,"['Asthenia', 'Bone pain', 'Chills', 'Dysphagia', 'Face oedema', 'Fatigue', 'Headache', 'Impaired work ability', 'Malaise', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Retching']",1,MODERNA,IM 928472,MD,39.0,F,"Moderna COVID-19 Vaccine EUA 7 days after the first injection of the Moderna vaccine, the area of my left shoulder where the vaccine was given became red, mildly sore, raised and warm. It was an area about 4 inches long and 2 inches wide. I also experienced some discomfort in my left underarm at the same time. My arm was sore, but not as sore as it was in the initial 24 hours after receiving the vaccine. I did not have a fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,PUB,Daily multivitamin,None known,None known,,None known,"['Injection site discomfort', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 928473,IN,54.0,M,"Have had sniffles and a scratchy throat with dry cough. Symptoms usually associated with a cold. Unsure if related to vaccine, but haven't been around anyone sick.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"Zyrtec, Protonix, Metformin, Glipicide, Ozempic and Linsipril.",None,Diabetes,,None,"['Cough', 'Rhinorrhoea', 'Throat irritation']",1,MODERNA,SYR 928474,CA,40.0,F,"Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right side headache, sore arm at site, nausea, dizziness, lethargic",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,SEN,Allegra was taken in the morning,None,Seasonal allergies,,No knows allergies,"[""Bell's palsy"", 'Dizziness', 'Ear pain', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Injection site pain', 'Lethargy', 'Nausea', 'Pain in jaw', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 928475,NJ,40.0,F,"Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is already elevated for me. About 9:30 my temp was 101.8F and they sent me home. I just had the chills and fever. I got home and developed a headache and around 1PM I started feeling really dizzy. The temperature did not subside and the next day I woke up and I couldn't function, I felt really dizzy I kept laying down and drinking water, I could not keep anything down my stomach did not feel well. I felt like I had to vomit. When I sat down in the toilet then my ears started ringing pretty bad all of a sudden I could not hear anything and I passed out in the toilet. My husband found me and tried to wake me up. After that I still feel dizzy. I did not have any appetite either. I could barely hold water. The next day I was not as dizzy but my stomach was still upset but I could hold some soup down but then started with diarrhea. Employee health kept calling me everyday and I did the the telehealth appt and I also had a little bit of a rash in my chest that appeared all of a sudden red like a streak. The dizziness I had for the first 4 days, diarrhea did not come until the 3rd day and I had it for 2 days and my temperature was back to normal on the 4th day. Everything started to get better (my stomach stopped feeling queezy) around the 4th day but still felt fatigued until about 12/29/2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,PVT,No,No,Polycystic ovary syndrome,,No,"['Abdominal pain upper', 'Chills', 'Decreased appetite', 'Diarrhoea', 'Dizziness', 'Erythema', 'Fatigue', 'Headache', 'Loss of consciousness', 'Malaise', 'Pyrexia', 'Rash', 'SARS-CoV-2 test negative', 'Tinnitus', 'Vomiting']",1,PFIZER\BIONTECH,SYR 928476,WI,62.0,M,Patient stated his arm from his elbow to his shoulder was warm for 1 hour. He also stated he was achy and he had joint aches more then usual.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Arthralgia', 'Injection site warmth', 'Pain']",1,PFIZER\BIONTECH,IM 928477,PA,44.0,F,"very fatigue and sore arm, headache, the night of the shot. 01/06/2021, Very fatigue, chills, fever, body aches, red spot where shot was given, slight headache, 01/07/2021 cough, sob, asthma like symptoms, headache, body aches, slight fever. 99.9, loose stools, 01/08/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,"very fatigued, slight fever, body aches, red spot where shot was given, headaches, loose stools. cough, sore throat. SOB, ( such as having an issue with my asthma)",none,history of asthma,,"bendryl, compazine, phergergan, reglan, iodine, sulfa, bee stings, bleach, codiene","['Asthma', 'Chills', 'Cough', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Headache', 'Injection site erythema', 'Pain', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA,IM 928478,UT,40.0,F,"Warm, swollen, erythematous spreading rash",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PUB,"Levothyroxine, Claritin",None,None,,"Sulfa antibiotics, Penicillins, Macrobid","['Rash erythematous', 'Skin warm']",1,MODERNA,IM 928479,TX,35.0,M,"I felt nothing for the 15 minute waiting period after the shot. About 35 minutes after the shot (while driving home) I noticed tingling on the tip of my tongue with mild lightheadedness, sweating, and shortness of breath. I pulled over, drank some water, and all these symptoms went away in less than a minute. I felt a little malaise on the drive home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"multivitamin, vitamin d, vitamin c, quercetin",none,none,,none,"['Dizziness', 'Dyspnoea', 'Hyperhidrosis', 'Malaise', 'Paraesthesia oral']",1,MODERNA,IM 928480,IA,61.0,F,"patient reports fasting high blood sugar >200 12+ hours after vaccination - she is diabetic on oral metformin and has never had elevated blood sugar >140 with fasting; controlled HgA1C at 6.1%; felt dizzy, nauseated, HA and sweaty as if she may pass out - never passed out",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,"Lipitor; metformin, losartan, co-enzyme Q-10",diabetes type 2 with oral medication control with metformin only and HgA1C 6.1 hypertension hyperlipidemia,same as above,,"penicillin, codeine, morphine, tramadol","['Blood glucose increased', 'Dizziness', 'Headache', 'Hyperhidrosis', 'Nausea']",2,PFIZER\BIONTECH,IM 928481,NC,60.0,F,Left Eye Swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,,no,,,,['Eye swelling'],1,MODERNA,IM 928482,KS,52.0,F,5 minutes after injection had internal thickening of throat and difficulty swallowing. After a couple of minutes swallowing improved but throat thickening continued for another approximately 15 minutes. At 50 minutes after the injection had faint tingling around the mouth and mild throat internal throat thickening again. Took 25 mg of Benadryl. No further s/s.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,WRK,"Lamictal, Pristiq, Topamax, Amlodipine, Losartan, Hydroclorothiazide, Wellbutrin, Magnesium, Potassium",,"depression, IBD, hypertension, vestibular migraines, Parkinsonism, hx of middles ear adenoma",,"Bactrim (throat swelling), Frova (hyper), Lisinopril (cough), Pepcid (palpitations) , Zofran (itchy throat), Sulfa (rash)","['Dysphagia', 'Paraesthesia oral', 'Pharyngeal paraesthesia', 'Throat tightness']",1,PFIZER\BIONTECH,IM 928483,CO,40.0,M,"Lethargy 10-15 minutes after vaccination. He said he could not stay awake. He said he felt himself going to sleep (chin going to chest); someone asked if he was ok. He then woke up and put his head back and hit it (""just a bink on the wall.""). Brought to ED via w/c from vaccination monitoring room. Assessed by this RN and as he explains it, he had a loss of consciousness. Ambulated to ED with steady gait; denied dizziness. He states he took a Percocet at 10AM on date of vaccination. He said he has taken Percocet in the past for sciatica and has never had this lethargy and what he reports as a loss of consciousness in the past.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,"Amlodipine, losartan, and labetalol for high blood pressure. Tacrolamus and mycophenolic for immune suppression s/p kidney transplant in 2018. Vitamin D and fiber",high blood pressure. immune suppression since kidney transplant in 2018.,high blood pressure. immune suppression since kidney transplant in 2018.,,Lisinopril causes angioedema,"['Glomerular filtration rate', 'Lethargy', 'Loss of consciousness', 'Somnolence']",1,MODERNA,IM 928484,ID,54.0,F,"Fever, headache, flu like symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Headache', 'Influenza like illness', 'Pyrexia']",1,MODERNA,IM 928485,MN,32.0,F,"Patient had her COVID injection on 12/29 and she developed numbness/tingling later that night in her arms, around 9pm (had vaccine at 2pm). She saw provider on 12/31/20 and was given gabapentin to try. She has been taking it twice daily and it helps a little. She said that the numbness seems to be getting less. She said it was all the way from the shoulder to the hands/fingers, now it's just in her hands and fingers. (Both sides, not just injection site). Circulation is good.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,UNK,,,,,,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 928486,,58.0,M,"Received a COVID-19 vaccination in his left arm and 915 this morning on 12/18/2020 and states that he felt some swelling sensation in his throat. He received 25 mg of Benadryl there initially and then a few minutes later got another 25. He had no chest pain or shortness of breath. He had no difficulty swallowing. He has had somewhat of a similar reaction in the past when he is exposed to cat hair. He was brought to the ED by EMS for further evaluation. No rash. Arrived 10:16am, received pepcid, declined steroids and discharged at 11:47am. Symptoms resolved within 2-3 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/18/2020,0.0,UNK,,,,,,['Pharyngeal swelling'],UNK,PFIZER\BIONTECH,IM 928488,NJ,48.0,F,"Developed fever ( Tmax 101), headache, nausea, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Aleve,None,None,,None,"['Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA, 928489,NC,33.0,M,"Fever, Headache, Malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,None,None,None,,None,"['Headache', 'Malaise', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928490,NJ,41.0,M,"Urticaria L. deltoid at Moderna vaccination site, Itching and redness that is localized to L. deltoid.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,PVT,Olmesartan 20mg,None,"HTN, GERD",,Penicillin,"['Injection site erythema', 'Injection site pruritus', 'Local reaction', 'Vaccination site urticaria']",UNK,MODERNA,IM 928491,NJ,40.0,F,"Day 8 following first dose of Modern swelling at injection site, indurated when palpated and itchy about 2.5-3 inches in diameter. Surface of skin is intact and otherwise unchanged.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,None,None,None,,"NKDA, None.","['Injection site induration', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 928492,MD,45.0,F,"(Right Arm) Swelling from shoulder to finger tips, Soreness from Neck(Right side) , shoulder blade, down arm to wrist, Hurts to move are especially to even with shoulder. I had trouble driving as Transit driver it made it too difficult for me to complete my whole shift( left half way through my shift).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,Losartan 100mg- once daily Hydrochorothizide 25mg- once daily Wellbutrin SR 200 mg -twice daily Fluticadone 50 mcg- once daily,"UTI, Fluid Build in both ears, Inflamed Sinuses, Stuffy Nose","ASTHMA, IBS, High Blood Pressure, Seasonal Allergies",,Mild Dermatitis Latex Sensitive,"['Arthralgia', 'Impaired work ability', 'Mobility decreased', 'Neck pain', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,SYR 928493,ME,25.0,F,after vaccine developed sensation of tongue swelling. No objective signs of swelling. Recieved 25 mg of benedryl with no improvement in 15 mins. She was very nervous and we decided to monitor her in ED. Also recieved famotidine there. Felt better and was discharged after an hour,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,sertraline,None,None,,None,"['Nervousness', 'Swollen tongue']",1,MODERNA,IM 928494,NH,31.0,F,"Sore arm, fatigue, feeling cold, sinus pressure and nasal congestion. Taking Tylenol and Benadryl, helping minimally .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,SEN,"Altavera, Claritin",,Asthma.,,"Only seasonal allergies, and household like dust and cigarette smoke.","['Fatigue', 'Feeling cold', 'Nasal congestion', 'Pain in extremity', 'Paranasal sinus discomfort']",1,PFIZER\BIONTECH,SYR 928495,GA,73.0,F,"1/8 3a after getting the vaccine had a fever of 101.00 treated with Advil, Nausea, weakness, chills. Not going to see a professional or go to urgent care because I have had covid in the past and I know a few people who have experienced this after the shot",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PUB,"advil, femera, protonix",Covid pos 11/29/2020,no,,no,"['Asthenia', 'Chills', 'Nausea', 'Pyrexia']",1,MODERNA,SYR 928496,OK,31.0,F,"Eye swelling, lip swelling and rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,PVT,"Mini pill birth control, Trazadone, Tizanidine, Zomig, Wellbutrin, One A Day vitamin, riboflavin, magnesium, b-12, vitamin D3, Botox Q3 months (migraines), Aimovig",None,"Migraines, anxiety, depression",,Latex,"['Eye swelling', 'Lip swelling', 'Rash']",2,PFIZER\BIONTECH,IM 928497,FL,66.0,F,Patient felt dizzy and experienced syncope. Left leg felt weaker than normal. Lactated ringers and meclizine 25 mg PO once provided in the emergency department. Patient was discharged from the emergency department.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,Neuropathy,,Penicillin,"['Computerised tomogram normal', 'Dizziness', 'Magnetic resonance imaging normal', 'Muscular weakness', 'Syncope']",1,MODERNA,IM 928498,NC,37.0,F,"16 Dec 2020 @1303: received dose at 0820, reports onset of chills and N/V sometime after 0900, >10 episodes, intermittent lightheadedness. Also mid-sternal, non-radiating CP described as ""burning and heaviness"" that began approx. 6 min before ED arrival. Given 1L NS IV, GI cocktail PO, and Zofran, Benadryl, Solumedrol, and Pepcid IVP. Reported complete resolution of symptoms at 16 Dec 2020 @1529.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,MIL,"Rizatriptan, Klonopin, Trazadone, Wellbutrin, D3",,"BH issues, IBS",,NKA,"['Chest discomfort', 'Chest pain', 'Chills', 'Dizziness', 'Electrocardiogram normal', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 928499,TN,48.0,M,On 12/25/20 I developed blisters at the injection site. It was painful and itched. Rash spread down my arm over the next week to my wrist. The rash is still present. My doctor is treating me for possible shingles and started me on an antibiotic for infection. I developed severe body aches and fever on 12/30 that lasted another 4 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,PUB,None,No,None,,No,"['Injection site pain', 'Injection site pruritus', 'Injection site vesicles', 'Pain', 'Pyrexia', 'Rash']",1,MODERNA,SYR 928500,OR,55.0,F,"I got the shot 8:15 p.m. on Tuesday the 5th of January. Wednesday my right arm was a little sore. On Thursday I felt fine until 6:00p.m. then I got an upset stomach and diarrhea. I took Imodium ad. This morning I still have diarrhea not as bad, but now I have the chills and a fever of101 degrees.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,PVT,GlipiZide 10 milligrams every morning.,no,Tendinitis of the left arm. IBS.,,crest toothpaste,"['Abdominal discomfort', 'Chills', 'Diarrhoea', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 928501,ID,32.0,F,fever and chills. i took medication to help with the fever and it did work. no medication was helping my symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,I took Tylenol 1000mg,none,none,,none,"['Chills', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 928502,MA,58.0,F,"12:00AM severe shaking chills, nausea, severe headache, fever 101.4 Tylenol and Motrin broke fever 3.30 AM ; headache still persists",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,,,high blood pressure,,,"['Chills', 'Headache', 'Nausea', 'Pyrexia', 'Tremor']",1,MODERNA,IM 928504,CO,30.0,F,"Adverse events: Morning of 1/7/2021, vaccine site started itching and got small hives, then throughout the day turned red, developed a hard mass, and became hot. Treatment: currently taking 600 mg of ibuprofen 3x per day and using cold compresses for 2 days. Drew a circle around the infested site and monitoring. Prescribed cephalexin if symptoms worsen and told to return to urgent care or see my pcp if I have to start antibiotics and symptoms still continue to worsen Outcome: redness seems to be decreased this AM and maybe slight decrease in size. Will continue with treatment course and address from there.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/07/2021,7.0,PVT,Low dose hormone IUD - Mirena,,Exercise induced asthma,,Apples and carrots,"['Injection site erythema', 'Injection site pruritus', 'Injection site urticaria', 'Vaccination site induration', 'Vaccination site warmth']",1,MODERNA,SYR 928505,CA,38.0,F,Sore Knees Hurt to bend knees hurt to stand up stomach pain throwing up,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Abdominal pain upper', 'Arthralgia', 'Dysstasia', 'Vomiting']",1,PFIZER\BIONTECH,SYR 928506,MA,35.0,F,"1 week after vaccination development of redness/hive-like rash/warmth/pruritis/pain distal to injection site. Have been monitoring, no medication started.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,multivitamins,none,none,,none,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth', 'Urticaria']",1,MODERNA,IM 928507,IN,54.0,F,Soreness at the site with swelling and red warm circle around injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,None,None,None,,Dye from CT Scan,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA,SYR 928508,OH,28.0,F,"Pt had reaction of redness and swelling to injection site. Second day of reaction increased swelling at injection site as well and lymph nodes in this arm swollen. Also stated it was hard, warm and swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,none,none,none,,nkda,"['Induration', 'Injection site erythema', 'Injection site swelling', 'Lymphadenopathy', 'Peripheral swelling', 'Skin warm']",1,MODERNA,IM 928509,MD,58.0,F,"AT APPROXIMATELY 8 AM , I BEGAN A ""SNEEZING FIT"" OF 12 OR SO CONSECUTIVE FORCEFUL SNEEZES. IT CONTINUED FOR SEVERAL MINUTES. I HAVE NASAL CONGESTION SINCE 8 AM (IT IS NOW 11:15 AM), SNEEZING, AND I AM CONSTANTLY BLOWING MY NOSE. I AM EXPERIENCING SEVERE COLD SYMPTOMS. I HAVE SORENESS IN THE ARM THE VACCINE WAS GIVEN. OTHERWISE I AM FEELING FINE.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PUB,"VITAMIN D, DAILY MULTI VITAMIN, GABAPENTIN,",None,"HTN , SCIATICA",,LISINOPRIL,"['Nasal congestion', 'Nasopharyngitis', 'Pain in extremity', 'Sneezing']",1,MODERNA,SYR 928510,MA,35.0,F,"Severe Light headedness and dizziness lasted for about 4 days Headache , Muscle ache , Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/23/2020,2.0,PVT,Dulera Zyrtez Lexapro Singulair Vitiam D flonase Omeprazole famotidine,None,Asthma Allergies depression Migraines,Protessive tdap - High Fever,Advair Kiwi Melon Latex Pertussis Vaccine,"['Chills', 'Dizziness', 'Myalgia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,IM 928511,TX,70.0,F,Moderna Covid-19 Vaccine EUA Rash and itching on left arm that was injected with the vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/07/2021,6.0,PVT,None,none,6 year survivor of uterine cancer,,Mold and dust - not on any allergy medication,"['Pruritus', 'Rash']",1,MODERNA,IM 928512,ND,40.0,F,"At about 10 minutes after administration, patient felt a bit lightheaded. She was given apple juice and was able to bring her mask down from her face and lightheaded feeling quickly resolved. BP 148/83 p 74.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Lexapro 20mg daily Albuterol inhaler- used prior to putting mask on before coming to vaccine clinic today.,,Asthma Anxiety psoriasis,Has felt dizzy after receiving flu shot in the past,Penicillin Sulfa,['Dizziness'],1,PFIZER\BIONTECH,IM 928513,MI,72.0,F,Resident passed away in her sleep,Yes,01/06/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,"Amiodarone Hcl, Carvedilol, Ferrous sulfate, Eliquis (cont)","Atrial fibrillation, Anemia, 1st degree AV block, CDK stage 4,","CDK stage 4, Atrial fibrillation, 1st degree AV block, Patient was under hospice care",,"Aldactone, contrast dye",['Death'],1,MODERNA,IM 928514,OH,21.0,F,"After shot, I had swelling of lips, hives on neck and arms, and red marks on hands. This was about 5 minutes after shot. Next day I had chills, nausea, headache, sore throat, and shakes. Started the afternoon of the next day. My arm has been red and itchy since the day, but it is increasing becoming warmed, bigger, and itchier every day since.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,Sprintec Citalopram,,,Menigencocal vaccine - 2017,"Peanuts, tree nuts - Epi pen Had an allergic reaction to the Menigencocal vaccine - hives and passed out","['Chills', 'Erythema', 'Headache', 'Lip swelling', 'Nausea', 'Oropharyngeal pain', 'Pruritus', 'Skin warm', 'Tremor', 'Urticaria']",1,MODERNA,SYR 928516,IN,24.0,F,"Body aches, headache, stomach ache, chills, nauseous, all at 9:00 pm 1/7/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PUB,None,None,None,,None,"['Abdominal pain upper', 'Chills', 'Headache', 'Nausea', 'Pain']",1,MODERNA,SYR 928517,FL,48.0,F,"Cellulitis, redness and warmness at injection site. Pt used tyelnol /Ice packs. Advise pt to watch the site. If area grows, go to urgent care",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/07/2021,9.0,WRK,Tylenol/ice-pack,none/unknown,none/unknown,,none/unknown,"['Injection site cellulitis', 'Injection site erythema', 'Injection site warmth']",1,MODERNA,ID 928518,NY,65.0,F,next day chills fever 102.3 body aches. pain at injection site an down the left arm all day..,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,none,none,none,,epinephrine,"['Chills', 'Injection site pain', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA, 928519,MI,25.0,M,"Rapid onset of headache, muscle aches, joint pain, and fever the evening after getting the shot. Injection arm soreness, general weakness. Minor cough, and possible throat swelling. Swollen lymph nodes. Treated fever with cool washcloth to the head all night . Fever reached a maximum of 103 �F at midnight. Around 5:30am took ibuprofen. All symptoms subsided by late morning around 9:30am, except for slight headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,None,Sore throat secondary to insufficient oral hygiene.,None,,None,"['Arthralgia', 'Asthenia', 'Cough', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Myalgia', 'Pharyngeal swelling', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928520,MN,37.0,M,"lower back pain , headache , fever",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,unknown,none,,,unknown,"['Back pain', 'Headache', 'Pyrexia']",UNK,PFIZER\BIONTECH, 928522,NV,65.0,F,8 days after vaccine right arm is still very sore with swelling and there is a defined red area that is 4cm diameter that is warm to touch,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/03/2021,4.0,OTH,inhaled steroid for asthma,none,asthma,,none,"['Erythema', 'Pain in extremity', 'Peripheral swelling', 'Skin warm']",1,MODERNA,IM 928523,MI,34.0,F,Been experiencing mild symptoms of the following since Tuesday morning post first dose of vaccination: Headache Body aches Fatigue/Tiredness Diarrhea Loss of Appetite Overall Head Fog Sore throat,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PHM,None,None,None,,None,"['Decreased appetite', 'Diarrhoea', 'Fatigue', 'Feeling abnormal', 'Headache', 'Oropharyngeal pain', 'Pain']",1,MODERNA,SYR 928524,CA,40.0,F,Arm itching red swollen at the sight of the injection hot to touch,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/07/2021,7.0,UNK,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 928525,,26.0,M,Injection was administered it directly below my acromion process approximately 1.5 inches above the deltoid IM site. There is a small hematoma at the site of injection which was not into a muscle.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/17/2020,0.0,WRK,,,,,,['Injection site haematoma'],1,PFIZER\BIONTECH,IM 928526,CA,68.0,F,"5 days after the vaccine, my right ear became itchy and red, then became swollen, Next day left ear became itchier than the right ear and swelled more. Took Xyzal in day and Benadryl at night. It has continued on , on the 9th day, my head became itchy. On the morning of the 10th day, my face looks red and rashy with my right eye swollen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,PUB,"Levothyroxine 50 mcg, Estroven Calcium with Vitamin D",,Thyroid,,Sulfa,"['Ear swelling', 'Erythema', 'Eye swelling', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 928527,NJ,57.0,F,"Soreness, redness, itching to injection site Severe headache Nausea, vomiting and diarrhea Symptom last about 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,WRK,None,None,High BP controlled Asthma controlled Seasonal allergies controlled,,Sulfer Shellfish?,"['Diarrhoea', 'Headache', 'Injection site erythema', 'Injection site pruritus', 'Nausea', 'Pain in extremity', 'Vomiting']",1,PFIZER\BIONTECH,IM 928528,TX,50.0,F,"that day, headache and arm soreness started. Headache and soreness tolerable with Tylenol for 2 days. Day 8 - on 01/06/21 - fingers, hands, and feet incredibly sore. Painful to do anything with fingers - staple, put on earrings, grip anything, etc. Feet hurt to walk. Joints in fingers swollen - can't wear rings. NP is my primary care - but she didn't administer the vaccine. Vaccine was done at Facility - offered and administered by the pharmacist.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,UNK,"Morning meds: Synthroid 150 mcg , B12 2500mg , Biotin 10000mg, Multivitamin Night meds: Melatonin 4mg, Magnesium 250mg, Colace",none,hypothyroidism,Flu shots make joints/bones ache,"Sulfa - throat itches PCN - face, lips swell","['Headache', 'Motor dysfunction', 'Pain', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 928529,TX,47.0,F,"Pt report bilateral cheek tingling. Treatment include Benadryl,",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/08/2021,2.0,PVT,,,,,,['Paraesthesia'],2,PFIZER\BIONTECH,IM 928530,LA,70.0,F,"The patient came into the pharmacy the morning following her vaccination 1/8/21 complaining of extreme pain on her right side near her ribs, stomach and lower back. She experienced this pain the same night of receiving her vaccine, and it disrupted her sleep. She also complained of difficulty breathing up on inhalation, saying that it hurts to inhale.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PHM,,,DIABETES,,"PHENAPHEN W/ CODEINE, BACTRIM","['Abdominal pain upper', 'Back pain', 'Dyspnoea', 'Musculoskeletal chest pain', 'Painful respiration', 'Sleep disorder']",1,MODERNA,IM 928531,VT,64.0,F,Dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,,,,,,['Dizziness'],2,PFIZER\BIONTECH, 928532,OH,39.0,F,"3x5 cm red induration that occured on day 8 post vaccination. Area is tender, bright red, and hard to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,PVT,Lisonipril 20 mg,None,Hypertension,,Bee stings,"['Injection site erythema', 'Injection site induration', 'Injection site pain']",1,MODERNA,IM 928533,IN,45.0,F,"Headache, Diarrhea with cramping",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,UNK,Vitamins,na,,,na,"['Diarrhoea', 'Headache', 'Muscle spasms']",2,PFIZER\BIONTECH,IM 928534,MN,35.0,F,"Redness, swelling, hot to touch, itching all at site of injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,PUB,"Nexium, escitalopram",,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 928535,KS,41.0,F,"Kept pt. for 30 minutes as precaution because of her previous history of allergic reactions to Morphine and Flagyl. At 30 minutes patient c/o being hot, feeling dizzy and having a HA. b/p was 140/90, HR 110, SaO2 96%. Did hear few upper airway expiratory wheezed. Called Doctor and she came and assesessed pt and ordered Benadryl 50 mg IM. Given at 3:10. Pt was also given 1000 mg Tylenol for fever of 100.6. Pt. was monitored and returned to baseline in 50 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,unknown,none,unknown,,"Morphine (rash), Flagyl hives for days","['Dizziness', 'Feeling hot', 'Headache', 'Pyrexia', 'Wheezing']",1,MODERNA,IM 928536,NH,37.0,F,"Ears ringing, fatigue, diarrhea, headache and dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/08/2021,7.0,PVT,,,,,,"['Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Tinnitus']",1,PFIZER\BIONTECH,SYR 928537,NY,61.0,F,"severe chills, fever to 101.9 (for 24hr), fatigue, next day diarrhea, nausea (no vomitting), diarrhea lasted over 24 hr. Day 3 lost voice, day 4 seen by medical provider for shortness of breath with activity (covid-19 swab done at that visit; no results as of this report)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Aphonia', 'Chills', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test']",1,MODERNA,IM 928538,CA,31.0,F,"I received my first dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness and shakiness. 12/24-30 fatigue, malaise. 12/31-1/4 Increased fatigue and malaise, migraines, body aches, intermittent dry cough, lightheadedness, photophoibia. 1/5-1/8 Intermittent lightheadedness, slowly improving body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,PVT,"Kurvelo birth control, one a day multi vitamin, vitamin d-3, ibuprofen and Tylenol for pain",,,,Pollen,"['Cough', 'Dizziness', 'Fatigue', 'Malaise', 'Migraine', 'Pain', 'Photophobia', 'SARS-CoV-2 test negative', 'Tremor']",1,PFIZER\BIONTECH,IM 928539,MN,60.0,F,Significant nausea that came on about 24 hours after the injection. No vomiting. Symptoms are significantly improved and subsiding at the time of this report.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,UNK,Niacinamide 500 mg Glucosamine Supplement,None,None,,Sulfa Environmental (dust) Lactose intolerance Sulfate intolerance,['Nausea'],1,PFIZER\BIONTECH,IM 928540,OH,56.0,F,"Tachycardia lasting 10 hours. ER visit with troponin, D dimer and labs drawn, ekg, chest xray . IV fluids with meds. Tachycardia slowly resolved late into the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,Levothyroxine,Covid 19 diagnosed 11/29/20,hypothyroidism,,"Dilaudid, Nubaine, Flagyl","['Chest X-ray', 'Echocardiogram', 'Electrocardiogram', 'Fibrin D dimer', 'Laboratory test', 'Specialist consultation', 'Tachycardia', 'Troponin']",1,MODERNA,IM 928541,CA,56.0,F,"Fever, runny nose, cough, tightness in chest, fatigue and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,None,None,Asthma,Influenza vaccine over 10 years ago - date unknown,"Allergic to bees, macadamia nuts and ibuprofen, relafen, lodine","['Chest discomfort', 'Cough', 'Fatigue', 'Headache', 'Pyrexia', 'Rhinorrhoea', 'SARS-CoV-2 test negative']",1,MODERNA,IM 928542,TN,49.0,F,"EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, she felt warm but she had a coat on and her eyes started to hurt and she felt tired but she works night shift. She felt this was normal for working the night before and having stayed up to get the vaccine. After her wait period she went to her car and remembers feeling warm for having to walk in the cold. Her right side of face became reddish purple and warm. She sat in car for a few minutes. As she drove her face started to swell and turn all red. When she arrived home she had heavy pressure middle of face-nose area. Her face continued to turn reddish purple with a rash on right side of face and down to her neck. She felt her sinuses and throat swell with irritation and in throat and wheezing. Her mom is a nurse and they waited to see if it worsen or got better. She decided since she could breath she would not go to hospital. After about 5 hours she felt much better. She continued to have a headache for 4 days. She had swelling and soreness of left arm for a couple of days. She continued to go to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,"Vit D3, Zyrtec, Synthroid, protonix, birth control, tylenol, imitrex",Healthy,MTHFR Gene and C677T mutation,,Bees,"['Discomfort', 'Erythema', 'Eye pain', 'Fatigue', 'Feeling hot', 'Headache', 'Pain in extremity', 'Pharyngeal swelling', 'Rash', 'Swelling face', 'Wheezing']",1,PFIZER\BIONTECH,IM 928543,IA,51.0,F,"Soreness in left arm at injection site similar to receiving flu vaccine. On 1/7/21 I had a headache, stiff/achy neck and shoulders and some chills. Upon waking on 1/8/21 my left armpit is sore and swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/08/2021,2.0,PVT,,None,None,,Latex sensitivity,"['Axillary pain', 'Chills', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Musculoskeletal stiffness', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 928544,ID,32.0,F,chills and fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,I took Tylenol 1000mg,none,none,,none,"['Chills', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 928545,CA,41.0,F,Sore arm Headache- all over pain like a sinus infection body sweats nausea weakness dry heaves fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,,,,,,"['Asthenia', 'Facial pain', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pain in extremity', 'Retching', 'Sinusitis']",1,PFIZER\BIONTECH,SYR 928546,MA,56.0,M,"fever, chills, body aches, fatigue, sweating also arm pain ongoing",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Pain', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA,IM 928547,MD,36.0,M,"Moderna COVID-19 Vaccine EUA Beginning roughly 29 hours after vaccination, began feeling significant pain on left arm and shoulders (side of injection site), making it difficult to raise arm. At 36 hours, pain when laying on that side or putting pressure on it. Cold chills and elevated temperature throughout second day, culminating in low grade fever that lasted one hour. General fatigue and dehydration throughout this period as well with periodic headaches. Symptoms mostly vanished by 48hr mark.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"Vitamin D, Flonase",,Asthma and allergies,,Penicillin,"['Chills', 'Dehydration', 'Fatigue', 'Headache', 'Injected limb mobility decreased', 'Injection site pain', 'Pain', 'Pain in extremity', 'Pyrexia', 'Tenderness']",1,MODERNA,SYR 928548,FL,72.0,M,"I experienced a chemical-like smell in my nose on the evening I received the vaccination (Jan.5), and on the next 2 days (Jan 6 and 7). The smell was sporadic and diminishing over the course of 3 days, and was no longer experienced on January 8.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Atorvastatin 10mg; Alfuzosin 10mg; 2 Tylenol capsules 500mg each; Vitamin D2 2000 IU; Vitamin B12 1000IU; Centrum Silver multivitamin for Men; Doxylamine Succinate tablet 12.5mg;,None,Sleep Apnea; enlarged prostate; Arthritis,Shingles Vaccination; 2nd shot with Shingrix: fatigue with aches and pain at injection site for 3 days. Received at age 71 on ,"allergic to pistachio and almond nuts,",['Parosmia'],1,MODERNA,SYR 928550,CA,50.0,F,0807: itchiness & sensation of heat in R arm ; sensation traveled down arm & across shoulder to L arm & bilateral ears,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PUB,benadryl PRN,,diverticulitis,,"peanuts, morphine, codeine","['Ear pruritus', 'Feeling hot', 'Pruritus']",1,MODERNA,IM 928551,WI,33.0,F,"I saw patient for a video visit on 1/7/2021. She reported rash at injection site 4 hours after vaccine. Fever to 104.6 at 6:00pm 1/5/2021. Numbness in tips of hands and toes. Widespread bodyaches. Swelling in lymph nodes of neck. Cough, Stuffy nose. In my clinical judgment, I also suspect a coincident viral upper respiratory infection in additional to vaccine adverse effect.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Multivitamin Sertraline 100mg,Left otitis media 12/17/20,generalized anxiety disorder,,Penicillins Bee venom Adhesive,"['Cough', 'Hypoaesthesia', 'Injection site rash', 'Lymphadenopathy', 'Nasal congestion', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vaccination complication', 'Viral upper respiratory tract infection']",1,MODERNA, 928552,SC,43.0,F,"DAY 9 - Redness/bump/sore at administration site (prior to day 9 no redness, arm was sore the first two days)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,SEN,"Multivitamin, Zinc, Vitamin C",None,None,,None,"['Injection site erythema', 'Injection site pain', 'Injection site rash']",1,MODERNA,IM 928553,VT,48.0,M,Tingly tongue and dry mouth; states had it with last vaccine. dizzy and nausea after getting to the Emergency Department,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Dizziness', 'Dry mouth', 'Nausea', 'Paraesthesia oral']",2,PFIZER\BIONTECH,IM 928554,TX,49.0,F,Patient report fever of 101.2 and chills. Treatment include Tylenol with improvement.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/08/2021,2.0,PVT,,,,,,"['Chills', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928555,FL,70.0,F,"Patient reported symptoms of chest pain, headache and dizziness. EKG, continuous telemetry, oxygen and labs were done. Chest pain lessened, headache remained the same and patient was given Tylenol. MD felt headache was probably r/t pre existing osteopathic changes in her neck and shoulder. Patient received meclizine and acetaminophen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,"erythromycin, Reglan, Toradol, Zithromax, Niacin SR","['Chest X-ray normal', 'Chest pain', 'Computerised tomogram normal', 'Dizziness', 'Electrocardiogram normal', 'Headache', 'Laboratory test', 'Troponin normal']",1,MODERNA,IM 928556,,22.0,F,not feeling well,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,,,,,['Malaise'],UNK,PFIZER\BIONTECH, 928557,MI,47.0,F,"10 minutes or so after injection, I had a strange sensation, became extremely shaky, sweaty and had tachycardia (152). Never became dizzy. No respiratory issues. Self resolved in a matter of minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Synthroid Vitamin D Iron Vitamin C,None,"Hashimoto thyroiditis Anemia Idiopathic V-tach (no meds, care of cardiologist)",,Penicillin,"['Condition aggravated', 'Feeling abnormal', 'Hyperhidrosis', 'Tachycardia', 'Tremor']",1,MODERNA,IM 928558,IA,57.0,F,Patient c/o fatigue and cough on 1.4.2021 and was encouraged to be tested for COVID. We were notified that the patient was hospitalized on 1.7.2021 with COVID symptoms and positive test results. She is currently on a ventilator and dialysis.,Not Reported,,Not Reported,Yes,,Not Reported,U,12/30/2020,01/04/2021,5.0,PUB,,,Lupus,,,"['Cough', 'Dialysis', 'Fatigue', 'Mechanical ventilation', 'SARS-CoV-2 test positive']",UNK,MODERNA,IM 928559,,26.0,F,"Onset of symptoms was day +7. Symptoms include: red rash just below injection site. Site is warm, red, and tender. About the size of a tennis ball.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,WRK,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Rash erythematous']",1,MODERNA,IM 928560,KS,57.0,F,hives almost an inch on left arm and hand with reddish and brown color,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,"Methylthenidatela, Aleve PM",,,,,"['Skin discolouration', 'Urticaria']",1,MODERNA,IM 928561,ID,19.0,F,"30 minutes after injection, had sore arm, ""hurting"" while breathing, increased heart rate, increased blood pressure; after arriving at ER, more than 1 hour after injection, had vomiting x 3, hives/welts on chest and arms, fever and chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,,,,,,"['Blood pressure increased', 'Chills', 'Heart rate increased', 'Pain in extremity', 'Painful respiration', 'Pyrexia', 'Urticaria', 'Vomiting']",1,PFIZER\BIONTECH,IM 928562,NH,62.0,F,"V safe was checking in with me for the first 7 days. I initially on the first day after having the shot had a headache and Very sore arm. The soreness lasted only one day and then no other symptoms until day 8. On day 8, the injection site was red, itchy and raised. Then yesterday, day 9 my are was tender to touch, VERY RED and HOT and expanding all over my arm, now in the back of my arm. All the time remaining afebrile. V-safe will only check in with me once a week from day 7, for 5 weeks, I am told so I wanted to report this. I am waiting for a call from my PCP. She is considering cellulitis, that is how red and hot it is but it is only tender, not hurting or requiring any pain medication. I have good range of motion, too.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/06/2021,8.0,PVT,"Lisinopril 10 mg. day; HCTZ 25mg. day and Klor-Con M10 MEQ day. Centrum Silver Women over 50, once a day",None,"High Blood pressure, High Cholesterol, Dermatoymositis",,No Known allergies to foods or medications,"['Cellulitis', 'Erythema', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity', 'Skin warm', 'Tenderness']",1,MODERNA,IM 928563,,36.0,F,"Seven days after vaccination a new, itchy, large erythematous patch appeared on the left arm around the site of vaccination and has not resolved currently.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,UNK,None,,None,,None,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 928564,OK,49.0,F,Numbness noted left lower lip area noted when woke up the morning after COVID19 Vaccine. The numbness subsided before noon same day,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/17/2020,1.0,OTH,Vitamin D3 Ibuprofen,,Hypothyroidism,,NKDA,['Hypoaesthesia oral'],1,PFIZER\BIONTECH,IM 928565,CT,22.0,F,Patient reported lightheadedness and feeling nauseas and faint about 2 minutes after vaccination. Placed supine for about 5 minutes with good effect. Water provided. Reported she did not eat breakfast this morning. Patient was in recovery for 30 minutes. Patient reported feeling well. Advised patient to complete VAERS side effect report. Picked up by boyfriend at 10:40. Advised patient to eat before next vaccine visit. Advised patient to lay down at next vaccine appointment. Patient stable at discharge.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,unknown,unknown,none,,nka,"['Dizziness', 'Nausea']",1,MODERNA,IM 928566,IL,35.0,M,"fever, chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Chills', 'Fatigue', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928567,,31.0,F,"Arm pain began on 1/2 at approximately 4 pm and gradually worsened. Was significantly improved by the next morning; however, lower back pain began around 4 pm on 1/3 and gradually worsened, peaking on 1/4 and 1/5. This is still slowly improving. Appears to be some sort of sacroiliac joint inflammation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,None.,None.,None.,,None.,"['Arthritis', 'Back pain', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 928568,WV,22.0,F,"Immediately after vaccination, the upper left arm had a small welt and the arm and shoulder.was very painful--she was unable to lift her arm. The next day, she was quite ill; she was extremely fatigued and slept 20 hours. The following day the symptoms disappeared. A week later the site of the vaccination became hot and a welt began to form. A day later, the welt expanded and is continuing to expand and is currently 3 inches in diameter. She is experiencing fatigue additionally. *Please note that her menses have begun 2 weeks before it should.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PUB,sucralfate ondansetron norethindrone pantoprazole metoprolol amitriptyline simethicone losartan hyoscyamine,none,high blood pressure anxiety irritable bowel syndrome,,"Crustaceans (shrimp, crab, lobster, etc) Sulfa medications","['Fatigue', 'Illness', 'Immediate post-injection reaction', 'Injected limb mobility decreased', 'Injection site pain', 'Pain in extremity', 'Urticaria']",1,MODERNA,SYR 928569,MA,39.0,M,"Pt c/o feeling lightheaded, ""seeing spots"" 10min s/p covid-19 vaccine. Pt notes that sx exactly the same as he experiences with blood draws, blood donations. NO LOC. EASED TO SUPIME POSITION. VITALS AS NOTED. SX RESOLVED W/O TX, VITALS AS NOTED. ADVISED TO NOTIFY STAFF OF THIS NEAR SYNCOPAL EPISODE WHEN HE RETURNS FOR DOSE #2. 10:50 BP 89/52 10:55 BP 92/56 IMPROVED 10:59 BP 116/74 ASYMPTOMATIC DX: NEAR SYNCOPE POST VACCINATION. RESOLVED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,None,"COVID positive on Dec. 6, 2020",None,,None,"['Dizziness', 'Presyncope', 'Visual impairment']",1,MODERNA,IM 928570,ME,34.0,F,hives on the left arm which progressed to the right arm and chest over 1 hour. Received 50mg on Benadryl,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,fluoxetine,none,none,,none,['Urticaria'],1,MODERNA,IM 928571,OH,36.0,F,"Upon vaccination, I had mild soreness in my right arm muscle on day 1 and day 2 (I have been reporting to the VSafe app). There were NO other symptoms or side effects including NO redness, lump/swelling, itching, etc. I felt fine. I woke up Wednesday, January 6th at 8am to some itching on my injection site. When lifting my shirt to look at it, I found a quarter sized, red swollen lump that was a little sore and hot to touch. I contacted my hospital employee COVID phone hotline and spoke with a nurse who transferred me to a doctor (11am) I sent a photo and described my arm. Dr. stated that it was unlikely an allergic reaction due to it being 1 week later. She diagnosed me with cellulitis and started me on Bactrim antibiotic. I took my first dose at 8pm on 1/6 and at 2:30am I woke up with stomach cramps and diarrhea. I woke up again on 1/7 with an elevated temperature at 99 and feeling nausea, diarrhea, fatigue, slight body aches and a large, red hot touch spot on my left ankle (I had a spider bite on my left ankle in Sept 2020 that was treated with Bactrim it healed no issues but this flare up occurred same spot). I continued to take the Bactrim (3 pills total since receiving the rx) and still felt sick. I spoke again with a new COVID hotline doctor on the phone APRN CNP who stated she believes I in fact do not have cellutitis but rather an allergic reaction to the Moderna vaccine and therefore I should cease taking the Bactrim and start Benadryl. I did that at 7pm 1/7 went to bed woke up and my ankle was better as was my arm although you can still see the circle. I followed up on 1/8 with APRN CNP via secure messaging with photos and she stated again I likely am allergic and to monitor.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"Birth control, pro-biotic, Zyrtec, Vitamin D, Tylenol or Advil as needed",None,None,,"Tobradex, Augmentin, nickel, general seasonal allergies","['Abdominal pain upper', 'Body temperature increased', 'Cellulitis', 'Diarrhoea', 'Fatigue', 'Hypersensitivity', 'Injection site pruritus', 'Malaise', 'Mass', 'Myalgia', 'Nausea', 'Pain', 'Skin warm', 'Swelling']",1,MODERNA,SYR 928572,,77.0,F,Facial drooping on 1/4/2021 6 days after the vaccine suffered a mild TIA or bells palsy event. appointments for a CT scan. Has mild facial drooping on the side that is already affected by TIA / cerebral hemorrhage. The long-term or permanent outcome is unknown.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/04/2021,5.0,SEN,,,,,,"[""Bell's palsy"", 'Cerebral haemorrhage', 'Facial paralysis', 'Transient ischaemic attack']",1,PFIZER\BIONTECH,IM 928573,WV,56.0,F,Moderna COVID-19 Vaccine EUA Sore at the injection sight Sinus drainage (Possibly unrelated to vaccine),Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,SCH,"Fluoxitine, multivitamin, vit C & E",Recent D&C on Monday of the week I was vaccinated.,PTSD,,Penicillin. cyflosporans,"['Injection site pain', 'Paranasal sinus hypersecretion']",UNK,MODERNA,SYR 928574,,42.0,F,"body aches, chills, headache, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 928575,LA,37.0,F,"-headache at the time of vacciene relieved totally with acetaminophen -post vacciene days 1 and 2 soreness in the muscle of the vacciene, totally relieved by tylenol and excersize -day 7 post vacciene, I woke up with right arm pain, itching and erythemia. i took tylenol and drank lots of water as well as moved my arm with daily activity -day 8 post vacciene continued symptoms same as day 7 just increased itching and redness, took benadryl 25mg and 500mg tylenol and proceeded with daily activities reporting today, day nine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,OTH,"No prescription medications, just taking a daily multivitamin and omega-3 supplement",none,eczema,,"PCN, Latex","['Erythema', 'Headache', 'Injection site pain', 'Pain in extremity', 'Pruritus']",1,MODERNA,IM 928576,WI,75.0,F,"Dizziness, causing 2 days missed work, lasting 4 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/04/2021,4.0,PVT,,,,,,"['Dizziness', 'Impaired work ability']",1,PFIZER\BIONTECH,IM 928577,PA,59.0,F,Numbness on the left side of face and ear. Lasted only about 4 hours from about 5pm to about 9pm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,"Tylenol, Magnesium, vitamin C",None,no,,Sulfa drugs,['Hypoaesthesia'],1,PFIZER\BIONTECH,IM 928578,,42.0,F,"I had my 2nd vaccine on 01/06/2021 and where the injection was done is now a big red spot around the area and has spread a tiny bit and it's warm to the touch with a hard bump. No other symptoms, except tired. no fever ect",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Fatigue', 'Injection site erythema', 'Injection site induration', 'Injection site warmth']",2,PFIZER\BIONTECH,IM 928579,NE,58.0,F,"Severe shivering and a temperature up to 103. My symptoms first started with a sore arm about 10 pm on the evening after getting the Moderna vaccine. Then at 1:30 am today I started getting severe chills and my temperature was 98.5 at 01:30 am, then 99.9 at 2:15 am, then 102.2 at 3:30 am with slightly less chills, then at 04:00 am I took Tylenol 1000 mg. At 4:35 am my temperature was 103.1 and minimal to no chills. At 05:30 am my temperature was 102.7 and my whole body felt hot and I did not have any chills. At 9:00 am my temp was100.3. At 10:30 am I began to have some chills again. My temperature at this time is 100.8 and I have a little bit of a headache too.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PUB,"Levothyroxine 0.025 mg daily Rosuvastatin 10 mg daily Vitamin D3 5,000 IU daily Elderberry 50 mg daily",None,Hypothyroidism,,NKA,"['Body temperature increased', 'Chills', 'Feeling hot', 'Headache', 'Pain in extremity']",1,MODERNA,IM 928580,,46.0,F,"EE received Moderna COVID vaccine and several hours later noted pain in shoulder / arm. Pain increased and ROM decreased. Employee was evaluated by clinician and it was determined that vaccine administration location was incorrect, and vaccine had been injected into bursa of shoulder. Steroid therapy and PT advised by clinician(s)",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,UNK,,,,,,"['Arthralgia', 'Mobility decreased', 'Pain in extremity', 'Product administered at inappropriate site']",UNK,MODERNA, 928581,NC,,F,5 minutes after received the shot I began to have tightness in chest and throat my BP went up high. Facility called the ambulance and I went to the hospital. ER stated I should f/u with cardiologist upon discharge as well as PCP.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,Methinisol,no,no,,penecillin,"['Chest discomfort', 'Electrocardiogram', 'Hypertension', 'Laboratory test', 'Myocardial necrosis marker', 'Throat tightness']",UNK,MODERNA,SYR 928582,MI,46.0,F,Arm is reddened around injection site the size of a 50 cent piece with some redness extending up to the neck. and neck lymph nodes are swollen,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,WRK,effexor and wellbutrin,none,depression and anxiety,,none,"['Erythema', 'Injection site erythema', 'Lymphadenopathy']",1,MODERNA,IM 928583,OR,29.0,M,Immediate induration without erythema or pain with needle retraction after vaccine given. Area marked with sharpe. Approximately the size of a nickel. A picture of the reaction site was taken with patient phone. He was encouraged to continue to document his reaction with more photos and report the reaction to vsafe patient was instructed to consult with his PCP if needed. He was instructed to seek immediate medical attention at urgent care or the emergency department if needed.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Immediate post-injection reaction', 'Injection site induration', 'Injection site pain']",2,PFIZER\BIONTECH,IM 928584,,42.0,F,"body aches, chills, headache, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 928585,KS,49.0,M,"On the evening of 1/6 patient started to develop flu like symptoms that continued through the morning of 1/7. Patient then begin to develop swelling in the left armpit/axillary region. As of 1/8 swelling was the size of an orange or grapefruit and described as being ""almost like subcutaneous swelling."" As of 1/8 the swelling could be seen through his shirt and looked like hypertrophy. Patient has taken photos for documentation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Metoprolol succinate 50 mg daily Aspirin 81 mg daily,None,Possible COVID-19 infection in March of 2020 that led to paroxysmal atrial fibrillation.,,None,"['Hypertrophy', 'Influenza like illness', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 928586,NY,36.0,F,"Chills, rigors, fever to 102F, headache, myalgias. All began around 7pm, persisted throughout night, fever broke at ~5am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928587,IL,37.0,F,Body aches and fever 100.4,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Multi vitamin,None,None,,None,"['Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 928588,MI,29.0,F,Fatigue Painful arm- both to touch and w/ mobility Unable to lift arm w/o extreme pain Swelling- localized at inj site Warmth- at inj site Numbness (minimal) in L hand Hand- slight redness,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PHM,None,none,none,,"Compazine, pristiq","['Erythema', 'Fatigue', 'Hypoaesthesia', 'Injection site swelling', 'Injection site warmth', 'Mobility decreased', 'Pain', 'Pain in extremity', 'Tenderness']",1,MODERNA,IM 928589,VT,44.0,U,"Flush, ""hot"", prickly, nausea syptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Hot flush', 'Nausea', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 928590,CA,31.0,F,"First dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness and shakiness. 12/24-30 Fatigue, malaise, soreness at injection site. 12/31-1/4 Migraines, increased fatigue and malaise, increased lightheadedness, body aches, intermittent dry cough. 1/5-1/8 decreased body aches, decreased fatigue, sustained lightheadedness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,PVT,"Kurvelo birth control, one a day women's multi vitamin, vitamin d, ib profen, Tylenol",None,None,,Pollen,"['Blood glucose increased', 'Cough', 'Dizziness', 'Fatigue', 'Injection site pain', 'Malaise', 'Migraine', 'Pain', 'SARS-CoV-2 test negative', 'Tremor']",1,PFIZER\BIONTECH,IM 928591,OH,38.0,F,"on 1/6/21, 9 days after 1st dose of moderna covid 19 vaccine, several inches below the injection site on my left arm began to feel tender to the touch, more firm than surrounding tissue, and warm. 2 days after these symptoms began they resolved (no longer firm tender or warm) but have been replaced by a large raised pink mark on my left arm in the same area that was previously tender warm and firm. the pink raised area has no discomfort.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,OTH,none,none,none,,none,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 928592,TX,85.0,M,"Red, blotchy, itchy spots on face",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/08/2021,2.0,PHM,"Triamterne/HCTZ, Rosuvastatin, Atenolol, Amlodipine",None,"None, healthy",,Folbee,"['Pruritus', 'Rash macular']",1,MODERNA,IM 928593,GA,29.0,F,"Milder sx initially with sore arm, myalgia's, subj. LGT. Lasted a couple of days and fine for 3 days. About 48+ hours ago developed HA, fever LG, myalgia's, and last night noticed oblong area of erythema and induration of right upper arm (14 cm x 9.5 cm). Warm, red , slightly tender to touch. No fluctuance. Seemed a bit better at time of visit and no fever in past 24 hours. Feeling better today. Size as above, confluent induration, mild warmth, erythema but not as red as pictures the night before.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,SCH,BUSPIRONE HCL 30 MG TABS; 1 TABLET TWICE DAILY SERTRALINE HCL 100 MG TABS; 4 TABLETS ONCE A DAY,None,"GAD, OCD, Osteopenia",,"No food, medication or immunization allergies","['Erythema', 'Headache', 'Injection site erythema', 'Injection site induration', 'Myalgia', 'Pain in extremity', 'Pyrexia', 'Skin warm', 'Tenderness']",1,MODERNA,IM 928594,TX,72.0,F,"Initially suffered a loss of taste about 4 hours after vaccination. Taste was better by 7 pm (8.5 hours after injection). After going to bed started to suffer chills and severe muscle aches. Took Motrin for the pain. Severe muscle aches and pain in sinuses continue at the time of submitting this report. My wife suffered similar side effects to the first Shingles. Additional Background information. my wife and I both tested positive for Covid on Nov 2 2020. We both took part in an phase 2 antibody trial. Since this is a double blind trial, we don't know who received the antibodies, but my wife's condition did not improve where mine improved almost immediately after the infusion",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PUB,None,None,None,Shingles,Sulfa,"['Ageusia', 'Chills', 'Myalgia', 'Sinus pain']",1,MODERNA,IM 928595,MI,38.0,F,Arm Pain and limited ROM in shoulder,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['Joint range of motion decreased', 'Pain in extremity']",1,MODERNA,IM 928596,FL,56.0,F,"Swelling, redness, hot to the touch, knot under the skin and pain if touched",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,WRK,"METPHROMIN, LISINOPRIL, SETRALINE, BUSPAR, SIMVASTIN, PROTONIX",,DIABETES,,,"['Erythema', 'Nodule', 'Skin mass', 'Skin warm', 'Swelling']",1,MODERNA,SYR 928597,PA,55.0,F,"Client developed swelling, redness, itchiness at injection site 9 days after receiving vaccine. Client states she had only mild soreness at the injection site the day after receiving the vaccine but it went away in a day",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PUB,"HCTZ, Welcol-cholesterol med, Vit. D, multivitamin",no,"High BP, cholesterol",,no,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 928598,AL,42.0,F,"patient complained of lightheadedness, patient initially declined any juice, patient was lowered back in recliner to wait through the 15 minute wait time. After 20 minutes patient agreed to take juice. after wait time of 30 minutes patient felt good to leave.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 928599,IN,38.0,F,"Low grade fever (99.5), aches, chills, nausea. Arm didn?t hurt as bad as 1st vaccination, but other symptoms were worse.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Na,None,Na,,Nka,"['Chills', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928600,,41.0,F,Employee received Pfizer COVID-19 vaccine and subsequently developed full body itching and reported feeling like tongue was swelling. Patient was given 50 mg PO Benadryl. No improvement patient was escorted to ED by RN for evaluation,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/18/2020,0.0,WRK,,,,,,"['Pruritus', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 928601,CO,33.0,F,"HA, Chest Tightness increased, patient felt hot, and inconsistent pulse, and felt as if she was going to pass out",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,WRK,sprilactone,no past COVID positive 11/13,POC,,Vicodin,"['Chest discomfort', 'Dizziness', 'Feeling hot', 'Headache', 'Heart rate irregular']",1,MODERNA,IM 928602,OH,35.0,F,"1/6/21 Large swollen lymph node noted to R axillary area, pain returned to R upper arm at injection site 1/7/21 large red circle appeared outlining injection site on R upper arm. Appointment with physician and antibiotic, Bactrim DS, ordered for cellulitis. Ultrasound R breast and R axillary ordered",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,PVT,"MVI, VIt D, Calcium, collagen, Nuvaring",None,None,,Augmentin- rash Morphine- Itching,"['Injection site erythema', 'Injection site pain', 'Lymphadenopathy']",1,MODERNA,IM 928603,,30.0,M,Patient reports about 3-4 days after the vaccine he started to have vivid dreams. He states the dreams lasted for about 1-2 weeks after they started.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/21/2020,3.0,MIL,,,,,,['Abnormal dreams'],UNK,PFIZER\BIONTECH, 928604,NY,36.0,U,"36 year old female, employee with no significant past medical history who presented to UCC s/p receiving first dose of COVID-19 vaccine and immediately thereafter developing chills and hypertension. RRT called with notable vital signs: BP 158/111, HR 101, T 36.5C, SpO2 99-100% RA. Patient received IV Benadryl 50 mg once. Vitals stabilized after observation.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,UNK,Prystiq,"generalized joint aches, psoriasis worsening, joint pain","psoriasis, seborrheic dermatitis",,"apples, walnuts, almonds, pears, peaches, uncooked","['Chills', 'Hypertension', 'Immediate post-injection reaction']",UNK,PFIZER\BIONTECH, 928605,AL,57.0,M,"Chills, low-grade fever, body aches, muscle and Joint and bone pain, sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,OTH,Lisinipril/hctz,"COVID 19 11/25/20 , symptoms appeared",Hypertension,,Penicillin,"['Arthralgia', 'Hypertension', 'Myalgia', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 928606,,60.0,F,"Progress Notes Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/6/2021 � Patient is a 60 y.o. female who was seen at SVH COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. � She denied any history of previous adverse reactions to vaccines. � She was given the Pfizer vaccination in the right deltoid muscle. � During her 15 minute waiting period after the injection, the patient began to experience throat tightness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. � This provider was notified of patient reaction and she was then assessed in the emergency bay area. � Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting. � No previous hx of vaccine reactions. � � ALLERGY REVIEW OF SYSTEMS: All other systems negative � � � Objective � Vitals Vitals: � 01/06/21 1705 01/06/21 1720 01/06/21 1724 BP: 134/82 (!) 145/84 134/72 Pulse: 94 80 77 SpO2: 97% 99% 100% � � Physical Exam Vitals signs and nursing note reviewed. Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Right Ear: External ear normal. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Musculoskeletal: Normal range of motion. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. � � � Assessment/Plan Treatment included: antihistamines and benadryl. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP. � � Diphenhydramine 25 mg given at 5:15 � Pt dismissed at 5:25.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,['Throat tightness'],UNK,PFIZER\BIONTECH, 928607,IL,58.0,F,"Felt ""not right"", minor 'thickness of my tongue', tightness of airway (all minor in severity)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,PVT,,,"Asthma, chronic renal disease, hypertension, obesity, peripheral edema,",,contrast,"['Feeling abnormal', 'Swollen tongue', 'Throat tightness']",1,PFIZER\BIONTECH,IM 928608,NY,32.0,F,The patient has almost immediate (2 minutes) redness and itching surrounding the site. She developed a 3.5? red circular rash with its center at the injection site. She did not develop any other symptoms. She was given Claritin with improvement in 30 minutes. She was observed for 1.5 hours and released with no further symptoms. She will take daily Claritin for a week. She has an allergic history (delayed hypersensitivity),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Albuterol, ibuprofen, Klonopin praxis in, Pristiq, omeprazole","Ehlers Danlos Syndrome, obesity, Seizure disorder, irritable bowel syndrome, meralgia paresthetica",,,"Augmentin, lanolin, adhesive","['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Rash erythematous']",1,MODERNA,IM 928609,FL,34.0,F,"On Sunday, January 3rd, I woke up to find a rash about 3 inches long, starting at the vaccination site. By Tuesday it had widened. I have photos of both Sunday and Tuesday?s rash, if you would like me to forward those to you. Wednesday night the rash had lightened in color, it was mostly just the outline, but had grown larger than my hand. It crept up towards my shoulder, underarm, and about half way down to my elbow. Thursday morning (yesterday) I called medical provider to make a Virtual Visit at 5:30pm same day. APRN, called me at about 12:20pm and told me to go to the ER right away. My throat felt swollen and constricted at the time, though I was able to breathe, drink and eat. Swallowing was a bit difficult. I was seen by PA, at the ER at MC. She evaluated me and said the reaction was bad, but not severe, and on the mend. She prescribed oral prednisone 20mg for the next five days. I did not need any steroid or Benadryl shots. She also said she feels comfortable with me getting the second COVID-19 vaccination, which is scheduled for 1/25.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/03/2021,8.0,PVT,Auvi-Q diclofenac Flonase hydrocortisone midol mylanta Levora-28,,,,cephalexin cornstarch lactose shellfish oats vaseline,"['Dysphagia', 'Pharyngeal swelling', 'Throat tightness', 'Vaccination site rash']",1,MODERNA,IM 928610,CA,50.0,F,"erythematous, lace-like, pruritic rash started 9 days after the vaccine on limbs and trunk",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/05/2021,9.0,WRK,Plaquenil Vitamin D3 Losartan/HCTZ Unisom,,HTN Rheumatoid Arthritis,,PCN and Keflex,"['Erythema', 'Rash', 'Rash pruritic']",1,MODERNA,IM 928611,OH,59.0,F,"After 7 days my injection site became ""itchy"", then bright red, mild swelling and very warm to the touch. Worsening after 24 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PUB,"Flecainide 50mg 1x/day, Vit D, E, Calcium and fish oil.",None,None,,No allergies.,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA, 928612,NE,59.0,F,"Chills, arm ache, vomiting, felt like breathing was heavy, fever, body aches, stomach pain in upper area.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"Fluvoxamine, Ziac, Synthroid, Omeprazole, Aspirin 81mg",Nasal Congestion,"Hypothyroidism, Restless leg syndrome, pernicious anemia, osteoarthritis of knees bilateral, hypertension, reflux disease",,"PCN, Tetracycline, Cefaclor, Sulfamethoxazole, Nifedipine, Amlodipine","['Abdominal pain upper', 'Chills', 'Dyspnoea', 'Pain', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 928613,,52.0,F,"Redness, swelling, warmth at injection site. Pain in armpit also.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/08/2021,9.0,UNK,,,,,,"['Axillary pain', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 928614,IL,52.0,F,"Day of vaccination a bruise developed. On day 9 (1-7-21) @ 8:15 am a localized reaction started. The area started itching then became red, hard, sore and warm. I put topical anti- itch cream on it twice during the first day. The final size on day 10 was 6cm X 7cm. I continue to apply anti itch cream and notify my HCP by telehealth.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/07/2021,8.0,PUB,,none,High blood pressure,,none,"['Contusion', 'Erythema', 'Induration', 'Local reaction', 'Pain', 'Pruritus', 'Skin warm']",UNK,MODERNA,IM 928615,IN,55.0,F,"48 hr. Flu like symptoms - fever 101.7, chills, severe body aches, headache and cramping.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,I didn't take anything until after I got home from work.,Was diagnosed with COVID on November 19th,Not to my knowledge. Just high cholesterol. which is treated with Praluent,,"Sulfa, adhesive tape (skin reaction), Grass, tree and weed pollen, dog, cat, dust, mold","['Chills', 'Headache', 'Influenza like illness', 'Muscle spasms', 'Pain', 'Pyrexia']",1,MODERNA,UN 928616,FL,32.0,M,"Patient had vasovagal syncope 10 minutes after Moderna vaccine administration. Patient was bradycardic (~40 HR) , pale, diaphoretic, and vomit x1 . Oxygen saturation at 100% at room air.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,None,,None,"['Bradycardia', 'Electrocardiogram abnormal', 'Full blood count normal', 'Hyperhidrosis', 'Metabolic function test normal', 'Pallor', 'Syncope', 'Vomiting']",1,MODERNA,IM 928617,MA,38.0,F,"Redness, swelling, at injection site. Seen by primary care provider, diagnosed with cellulitis and given doxycycline as treatment",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/04/2021,6.0,PVT,,,,,,"['Cellulitis', 'Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 928618,CA,62.0,F,Headache joint aches ache at the injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Arthralgia', 'Headache', 'Injection site pain']",1,MODERNA,SYR 928619,NJ,35.0,F,"Received vaccine on 1/6. Woke up on 1/7 at 1 AM with severe headache and chills. Took ibuprofen, which helped. The chills lasted for a couple hours. Still has slight headache and fatigue on 1/8.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Headache']",2,PFIZER\BIONTECH,IM 928621,FL,42.0,M,"Aches, diarrhea, vomiting, pneumonia, fever, chest pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/27/2020,1.0,PUB,Zquill,,Depression,,Iodine,"['Chest pain', 'Diarrhoea', 'Pain', 'Pneumonia', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 928622,FL,37.0,F,"Two days post vaccination, patient noticed redness and swelling at injection site. Then on day 7 post-vaccination, redness and swelling spread and itching began. Redness and swelling continued to spred from day 7-10. Patient saw her primary care physician who diagnosed it as a localized allergic reaction. They prescribed benedryl, Claritin and doxycycline.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,,Seasonal Allergies,"Asthma, Hypothyroidism, High Cholesterol",,"Ceclor, Penicillin, Latex, Mustard","['Hypersensitivity', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Local reaction']",1,MODERNA,IM 928623,,34.0,F,felt nausea/vomiting a few mins after getting vaccine. pt has prior hx of feeling similar symptoms in the past from other shots especially when she doesn't eat. only had coffee this morning,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,None,"['Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 928624,NY,66.0,F,"Pt reported a flushing feeling, then tightness in her chest; given 50 mg of diphenhydramine, then 0.3 mg of epinephrine IM. Pt's symptoms resolved. No further incidents",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,unsure,,"allergies, chronic hives",,"Multiple allergies, both environmental and to medications","['Chest discomfort', 'Flushing']",1,MODERNA,IM 928625,IL,17.0,M,"COVID VACCINE WAS GIVEN TO UNDERAGE PT. PT IS ONLY 17 YRS OLD, TURNS 18 IN MARCH. VACCINE NOT APPROVED FOR SOMEONE UNDER THE AGE OF 18. NURSING FACILITY WAS NOTIFIED. THEY SAID THEY WOULD NOTIFY PARENTS. PATIENT HAS NO ADVERSE SYSMPTOMS AT THE TIME VACCINE WAS GIVEN. FACILITY SAID THEY WILL MONITOR PT.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,SEN,,,CEREBRAL PALSY CONGENTIAL HYDROCEPHALUS SEIZURE,,,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 928626,NJ,36.0,F,"chills, body aches, headaches. lasting about 24 hours. improved with tylenol. Symptoms similar to those experienced with covid infection 2 weeks prior, but felt 10x worse.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,none,"covid positive on 12/15/2020. I was pregnant, delivered on 12/24/2020.",none,,none,"['Chills', 'Headache', 'Pain']",1,MODERNA,IM 928627,NC,38.0,F,Today morning one of the employee at nursing home had a reaction to Covid vaccine. I or technician gave the shot to her around 9 am to 9:15 am this morning initially she had no reaction to shot but around 10:30 am ( by this timewe were at the another clinic ) She called the nurse who was with us and informed us that she is having dizziness and feeling weird (we asked her to measure the blood pressure the reading was 122/99) then she mentioned she Is feeling good butin next 2 minutes she fainted and fell and hit her head on countertop then they called 911. My last conversation related to this incident was she is diagnosed with low blood pressure and they will do other test to make sure she is fine.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PHM,"VENLAFAXINE, TRAZODONE, PROPRANOLOL",,HISTORY OF HYPOTENSION,,NKDA,"['Dizziness', 'Fall', 'Feeling abnormal', 'Head injury', 'Hypotension', 'Syncope']",1,MODERNA,IM 928628,CA,62.0,F,Headache joint aches ache at the injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Arthralgia', 'Headache', 'Injection site pain']",1,MODERNA,SYR 928629,NJ,60.0,F,"Sore arm, chills, temp= 100 On 1/8/2021 temp=100.8, body aches, sore arm Took Tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Calcitrate Mg Ox,None,Osteoporosis Benign heart arrthymias,,Compazine,"['Body temperature increased', 'Chills', 'Pain', 'Pain in extremity']",1,MODERNA,IM 928630,MA,32.0,F,"Initial reaction of muscle soreness which subsided over 2-3 days, but eventual full body sensation of being hot/sweaty without measured change in body temperature through thermometer. The overheating occurred for 3 days before beginning to subside. It was accompanied by some slight chest pain on day 5 post-vaccine, which has also mostly subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/04/2021,5.0,WRK,"Seroquel 25 mg, omeprazole 20mg",,GERD,,"Lidocaine, penicillin, tylenol","['Chest pain', 'Feeling hot', 'Hyperhidrosis', 'Myalgia']",1,MODERNA,IM 928631,WI,37.0,M,"Chills, whole body muscle pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PUB,Daily Multi Viatimin,None,None,,None,"['Chills', 'Pain']",1,MODERNA,IM 928632,FL,43.0,F,"Headache, muscle aches, weakness, low grade of fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,pravastatin,none,none,,none,"['Asthenia', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928633,TX,50.0,F,"Patient complained of tingling in head, lightheaded and dizzy with a rapid heart rate. EMS on site for event, patient seen and released. Patient continued on site for an additional 30 minutes before heading home. Patient stated she feels better, closer to baseline but not completely normal. Referred her to sign up for v-safe and call 911 or go to the nearest emergency room if she has any further issues,",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PUB,,,,,,"['Dizziness', 'Feeling abnormal', 'Heart rate increased', 'Paraesthesia']",1,MODERNA,IM 928634,OR,53.0,F,"48 hours after the COVID 19 Vaccine I experienced SOB, cough and sore throat (along with the expected low grade fever, body aches and fatigue).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,PVT,None,None,Migraines,,"Vistaril, iodine, oxycodone","['Cough', 'Dyspnoea', 'Fatigue', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 928635,IA,62.0,F,"Patient reported feeling flushed and shaky after injection. Episode was short lived. After second episode it was decided to transport patient to ED for evaluation via wheelchair. ED notes: patients states she felt very flushed, cheeks were flushed, very slight itchiness in her mouth and tongue and very slight nausea and very shaky. Denied shortness of breath or chest pain. Medications given: 1815 diphenhydramine 50mg IV 1820 methylprednisolone 125mg IV Normal saline bolus 1840 famotidine 20mg IV 1817 hydroxyzine hydrochloride 50mg IM 1841 epinephrine 0.3mg IM 1823",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,labetalol 200mg lisinopril 20mg salmon oil magnesium oxide multivitamin loratadine 10mg amlodipine,,allergic rhinitis anxiety depressive disorder hyperlipidemia hypertension hypothyroidism neurogenic bladder obesity obstructive sleep apnea syndrome,,cashew nut lisinopril sulfa drugs,"['Flushing', 'Nausea', 'Oral pruritus', 'Tongue pruritus', 'Tremor']",1,MODERNA,IM 928636,CA,43.0,F,"Numbness and tingling of lips, and jaw numb, noted on her way home from hospital. Checked in with vaccine clinic to report symptoms and be monitored for 30 minutes.Took 50mg Benedryl. Symptoms resolved 12/28/2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,PVT,"Motrin, prn.",Viral infections-- swollen lymph nodes. Unknown virus. Treated two weeks prior to vaccine.,No.,MMR,"PCN, codeine","['Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 928637,IL,58.0,F,"Swelling of the tongue, feeling ""not right"", tightening of the airway (all mild and short duration)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,,,"Asthma, chronic renal disease, hypertension, peripheral edema, dyslipidemia",,"IV contrast, aspirin","['Feeling abnormal', 'Swollen tongue', 'Throat tightness']",1,PFIZER\BIONTECH,IM 928638,,35.0,F,"COVID-19 vaccination administered IM in left deltoid around 6am. Patient called pharmacy around 10am and complained that the injection was delivered too high and she was experiencing pain at the site. Vaccine placed high on L shoulder, just below acromion process, at or above humeral head. Seemingly placed between acromion process and humeral head, near or in soft tissue/bursa. Site pain is inflammatory in nature and does not seem to affect muscles, but instead is contained within joint itself.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/19/2020,0.0,WRK,,,,,,"['Injection site inflammation', 'Injection site pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 928639,CO,43.0,F,"Per patient report: ""Received my 2nd dose Jan. 5,2021 @ 1020 noticed pain and tenderness in Left arm injection site, armpit of the same side and radiating pain across neck and shoulder to right side by the next morning Jan.6. Late afternoon pain increased in left armpit significantly and noticed swelling, warmth and hardness along with stabbing pains in left forearm and hand throughout the night. """,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Arthralgia', 'Induration', 'Injection site pain', 'Injection site warmth', 'Lymphadenopathy', 'Neck pain', 'Pain']",2,PFIZER\BIONTECH,IM 928640,OK,50.0,F,"Immediately after client got her vaccine, she started feeling dizzy, and tingling ""all over her body."" She was monitored and placed in a reclining position which did not help her. At 11:30 am client reported feeling weak. EMS was called and client was transported to hospital. She was given IV fluids and monitored and released 2-3 hours after the incident. She has not had any other problems since taking the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,"fluoxetine, gabapentin, flexeril, vitamin D",none,none,,no known allergies,"['Asthenia', 'Dizziness', 'Immediate post-injection reaction', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 928641,NJ,30.0,F,Temperature increase day after vaccine from usual temp of 96.0 to 99.0 which decreased without medication after about 4 hours. Developed facial rash 2 days after vaccine that still remains on face. No issues breathing and no rash noted anywhere else on body.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PHM,"Multivitamin, vitamin C, probiotic, biotin, zyrtec, nasonex",None,Allergic rhinitis and seasonal allergies,,"Longstanding seasonal and environmental allergies to grass, trees, pollen, dust, mold, dogs, and cats",['Rash'],1,MODERNA,IM 928642,OH,61.0,F,"Patient was brought to the ED after receiving the Moderna vaccine for difficulty breathing. Per RN progress note: ""Pt arrived via wheelchair from auditorium, pt had received her first COVID vaccine left deltoid, approx. 10 minutes later pt appeared to have an anaphylactic reaction, pt arrives wheezing and tachypneic, labored breathing with accessory muscle use."" The patient was placed on supp oxygen and received epinephrine 0.5mg IM x1, Benadryl 50mg IV x1, hydrocortisone 200mg IV x1, lorazepam 1mg IV x1. Pt discharged after 6 hour observation with Rx's for EpiPen, prednison, Benadryl, and famotidine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Cymbalta, Breo Ellipta, Ventolin, carvedilol, amlodipine, lisinopril, dulaglutide",,"Asthma, T2DM, diabetic neuropathy, HTN, depression",,"N/A: According to medical record and the vaccine pre-screening questionnaire, pt does not have a history of severe allergies or anaphylaxis.","['Anaphylactic reaction', 'Dyspnoea', 'Tachypnoea', 'Use of accessory respiratory muscles', 'Wheezing']",1,MODERNA,IM 928643,PA,37.0,F,"developed raised striatians to abdomen and left and right flank area on 12/18/20 at 12 am, no treatment, resolved on 12/20/20 at 12 am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,OTH,multivitamin 20 mg prozac daily,denies,denies,,bees-severe swelling,['Rash papular'],1,PFIZER\BIONTECH,IM 928644,OK,59.0,M,"General Side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and fever. I have experienced all these side effects every day for the last 10 days. Additional side effects are: Sweating profusely every night. Not being able to sleep very well nearly every night. Stomach upset if I eat or if I do not eat. I am only able to eat very bland food since anything else upsets my stomach. I can not drink carbonated beverages since they upset my stomach. As of yesterday I started getting little red sores on my back. This morning it moved to my chest in addition to my back.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,"Metformin 500 mg 2x a day, Lisinopril 2.5mg, Atorvastatin 20mg",None,Type 2 diabetes,,No,"['Abdominal discomfort', 'Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Influenza virus test negative', 'Myalgia', 'Nausea', 'Night sweats', 'Pyrexia', 'SARS-CoV-2 test negative', 'Skin ulcer', 'Sleep disorder']",1,MODERNA,IM 928645,MN,55.0,F,"9 6:30 Pm 01/07/2021 broke out into a rash on arm and leg , side headache and front headache, Waive of extreme tiredness . Arm at the site started to itch and swell huge , very hot and sensitive to the touch",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,OTH,"Atenolol, Levothyroxine lisinopril, cranberry supplement Fish Oil Aspirin , CBD oil, B multi vitamin",No Possible Kidney stone,High Blood pressure,Flu Vaccination back in the early 90's,"Bupropion , Metals, Kiwi, Indoor outdoor allergies","['Fatigue', 'Headache', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Rash']",1,MODERNA,SYR 928646,MI,37.0,F,Rash on left arm and chest,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,SEN,Unknown,None at time of vaccination.,None,,NKA,['Rash'],1,MODERNA,IM 928647,AL,44.0,F,"Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became hard to breathe, my fingers were tingling and my mouth got very dry. I pulled over and called 911. The paramedics stated my BP was within normal limits of around 140/80. My normal is closer to 90/65. Once symptoms resolved I attempted to drive home. Once again, the same symptoms returned. I pulled over. I then made my way to a safe location and waited for family to come. Since the event I have had times of mild labored breathing while walking. While driving I become very anxious and the feelings of an anxiety attack return. I saw my nurse practitioner 2 days ago who referred to the driving anxiety as a form of PTSD and prescribed Prozac and Xanax. I have not take the Xanax, but have taken two nighttime doses of Prozac. Yesterday, I did not feel as though I had taken medication. My drive to work was uneventful. My drive home involved tightening of the chest, labored breathing and anxiety. This morning I cannot tell if I am feeling the vaccine or Prozac in my system, but I feel off. Swimmy headed, watery mouth, heaviness in my arms and shoulders. I need guidance on taking the 2nd vaccine or if I should seek further medical treatment. I have added a vit B vitamin a day to my regimen since the date of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,"Bromalan, vit C, Zinc 25mg, women's multi vit, tumeric",None,"Mild feelings of anxiousness, treated for mild anxiety 3-4 years ago with Xanax as needed, never needed to refill rx",,Sulfa drugs,"['Anxiety', 'Chest discomfort', 'Dyspnoea', 'Feeling abnormal', 'Limb discomfort', 'Palpitations', 'Post-traumatic stress disorder', 'Thirst', 'Tremor']",1,PFIZER\BIONTECH,SYR 928648,NH,40.0,M,"fever 101, severe body aches, nausea, loss of appetite, gi upset, fatigue x 2 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,UNK,none,none,mild hypertension,,none,"['Abdominal discomfort', 'Decreased appetite', 'Fatigue', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 928649,CA,40.0,F,"Nausea, cold sweats, vomiting, mild hives",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,Amlodipine 10 mg daily,None,Hypertension,,None,"['Cold sweat', 'Nausea', 'Urticaria', 'Vomiting']",1,MODERNA, 928650,AZ,47.0,M,"BACK/ABD. PAIN, IRREGULAR BOWEL MOVEMENT",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Abdominal pain', 'Back pain', 'Bowel movement irregularity']",1,PFIZER\BIONTECH,IM 928651,MI,38.0,F,Low grade fever and body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 928652,UT,60.0,F,"Dizziness with first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in left deltoid. Monitored vitals, which remained stable. Patient thought it was more of a mental effect because of something that a friend told her about the vaccine. Patient was reassured and when she felt better, was released back to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 928653,VA,38.0,F,"fever, body aches, vomiting, diarrhea. BP 210/110, felt ""raspy"" in chest",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Bupropion 150mg 1 po BID Diclofenac 75mg PRN Hydrocodone5mg-Acetaminophen 325mg PRN Hyoscyamine 0.125mg PRN Methocarbamal 750mg TID Phentermine 30mg 1 po QD Prazosin 1mg q PO QHS,,PTSD,,Aspartame,"['Diarrhoea', 'Pain', 'Pyrexia', 'Rales', 'Vomiting']",1,MODERNA,IM 928654,CO,36.0,F,"1/7/21 @ 16:25 Dizziness, headache, nausea. Epinephrine administered",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,,,,,"Avocado, possible sulfa","['Dizziness', 'Headache', 'Nausea']",1,MODERNA,IM 928655,CO,55.0,M,"Chills, HA, body aches, back pain, upset stomach, fatigue, burning sensation in throat as he breathes in",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,,Past COVID 11/30/20 - symptomatic,,,,"['Abdominal discomfort', 'Back pain', 'Chills', 'Fatigue', 'Headache', 'Pain', 'Throat irritation']",1,MODERNA,IM 928656,MI,38.0,F,"HTN, Blurry Vision, Blood shot eyes",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Hypertension', 'Ocular hyperaemia', 'Vision blurred']",1,MODERNA,IM 928657,NJ,55.0,F,"within 5 minutes became lightheaded, flushed, tachycardia , itching in both hands Given Benadryl 25 mg , Pepcid , solu-medrol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,Hypothyroid heart mumur,,,Bee venom protein,"['Dizziness', 'Flushing', 'Pruritus', 'Tachycardia']",1,PFIZER\BIONTECH,IM 928658,NM,64.0,M,"Vasovagal- Lightheaded, weakness with standing- patient said he was not dizzy. Stood up/ sat down 3x. Outcome: Rest, recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,,,,,,"['Asthenia', 'Dizziness', 'Presyncope']",1,PFIZER\BIONTECH,IM 928659,OH,32.0,F,"First develop axillary pain starting on 1/5 then noticed that the injection site was becoming swollen. On 1/6 I was nauseous on and off throughout the day had to take Zofran. 1/7 the swelling on my arm worsened with redness and warm, axillary pain continued, and had some nausea with diarrhea as well. Today, 1/8 injection site is less red but still swollen with axillary pain, and I can palpate and enlarged axillary lymph node.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,PVT,Sprintec oral contraceptive,None,IBS,,None,"['Axillary pain', 'Diarrhoea', 'Erythema', 'Injection site swelling', 'Lymphadenopathy', 'Nausea', 'Peripheral swelling', 'Skin warm']",1,MODERNA,IM 928660,PA,37.0,F,patient states that on 12/18/20 she developed a raised rash to abdomen and left and right flank area,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,OTH,multivitamin and prozac,denies,depression,,bees-swelling,"['Rash', 'Rash papular']",1,PFIZER\BIONTECH,IM 928661,TX,32.0,F,"Patient complained of feeling anxious with a rapid heart rate immediately after immunization. Patient checked out by EMS, began feeling better shortly thereafter. Patient advised to call 911 or go to the nearest emergency room for any additional issues as needed. Also advised to sign up for v-safe. Patient left site stating he felt better.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PUB,,,,,,"['Anxiety', 'Heart rate increased', 'Immediate post-injection reaction']",1,MODERNA,IM 928662,NY,50.0,F,"On December 25th I had mild chest pain and then on January 1st, 2021 I had severe chest pain that persisted and on January 3rd I was admitted into the hospital. My Ddimer was elevated and my Troponin levels were elevated. An angiogram was performed and Dr. injected nitro into my arteries because they were constricted from Coronary Spasms.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,12/23/2020,01/01/2021,9.0,PVT,Synthroid Imitrex,None,Graves Disease Gerd,,Penicillin Sulfa drugs,"['Angiogram abnormal', 'Arteriospasm coronary', 'Chest pain', 'Fibrin D dimer increased', 'Troponin I increased', 'Vasoconstriction']",UNK,PFIZER\BIONTECH,IM 928663,AR,20.0,F,"100.0 fever, aches, chills, nausea, headache, sore arm, fatigue. last night had trouble breathing",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,birth control,Covid19 positive 12/10,,"age 1, varicella vaccine, high fever, rash all over body",penicillin,"['Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA,IM 928664,CO,61.0,M,"Ache began in neck/shoulders after chills. This happened around lunch 1/7/21. Took acetomenphin . Chills and aches continued until into the night. Took Temperature around 2:30 am 1/8/21 and it registered 99.8. Took more acetomenphin and sweated it off. Aches and chills continue today, 1/8/21 into lunchtime. Taking acetomenphin approximately every 4-6 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PUB,"Lisinopril, Amlodipine, centrum vitamins","Hypertension, Gout",Gout,,Allopurinol. Colcris Shellfish,"['Arthralgia', 'Chills', 'Hyperhidrosis', 'Neck pain', 'Pain']",1,MODERNA,SYR 928665,NH,44.0,F,"nausea, lightheaded within 30 minutes no other symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"allegra, albuterol, nexium",none,"asthma, GERD, allergies",,"amoxicillin, tree nuts, molds, animals, pollen, beets, grapes, cherries, dust, mites","['Dizziness', 'Nausea']",1,MODERNA,IM 928666,IL,26.0,F,"24 hours later a 100.8 fever, chills, and muscle aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,Birth control-apri Velaxfaxine Linzess Ferocon,None,Endometriosis,,None,"['Chills', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 928668,IA,35.0,F,"AT APPROXIMATELY 2:00PM, DEVELOPED TEMPERATURE (100.5), REMAINED ELEVATED AT 3:35PM SAME DAY.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,SEN,,,,,,['Body temperature increased'],1,PFIZER\BIONTECH,IM 928669,TX,30.0,F,"Pain(3/10) to injection site x24hours. Swelling x14hrs. Still currently, red swollen, No self treatment",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,Clomiphane,NO,NO,,NKDA,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",UNK,MODERNA,IM 928670,TX,51.0,F,"I started few hours later started feeling thought it was stress. The next morning around 9am high moderate pain left leg jaw, chest hurt, sudden panic attack and I had to calm down for minutes. I informed my coworker I was having a reaction and then it stopped. Then I scheduled an appt with my PCP had lab work, EKG results was normal. On 12/24 still exp high mild left jaw pain, heart racing and chest pain .I was scheduled stress test on 12/30 was normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,"Over the counter Vit, Allegra,Biotine,V6, V12, Zinc, Aspirin, Losartan, Topamax, Singular, Myrbetriq Metformin, Blood Thinner, Folic Acid, Calcium, Garlic, Vertex, Glucosamine with Vit D, 2 Nasal sprays, Flonase, Azelastine",No,"Blood pressure, Hypertension, Pre Diabetic",,"Jelly Beeswax, Januvia, Baclofen, Latex (Band-Aids)","['Cardiac stress test normal', 'Chest pain', 'Electrocardiogram normal', 'Laboratory test', 'Pain in extremity', 'Pain in jaw', 'Palpitations', 'Panic attack']",1,PFIZER\BIONTECH,IM 928671,WI,32.0,F,Pfizer-BioNTechCovid-19 vaccine EUA. Headache and migraine lasting approximately 36 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/31/2020,3.0,WRK,"Adderall XR, ibuprofen",None,"ADHD, hyperhidrosis",,"Atenolol, topamax","['Headache', 'Migraine']",1,PFIZER\BIONTECH,IM 928672,UT,19.0,F,"Dizziness with Pfizer-BioNTech COVID-19 vaccine second dose 0.3 mL IM in right deltoid. Called RRT. Obtained vitals, which were stable. After monitoring, patient released without treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,['Dizziness'],2,PFIZER\BIONTECH,IM 928673,IL,32.0,F,"Between 3am-6am on Monday, January 4th, I experienced chills, fever, body and joint pains, nausea, and vomitted. Throughout Monday, I was weak and tired with a fever and body ache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,PVT,Birth control and multivitamin,None,None,,Benadryl and Vicodin,"['Arthralgia', 'Asthenia', 'Chills', 'Fatigue', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",UNK,MODERNA,IM 928674,IA,35.0,M,"hypertension, tachycardia,neck stiffness, anxiety",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,depakote symbalta,,treated osteoblastoma,,"environmental allergens mri contrast has had ""anaphylaxis""","['Anxiety', 'Hypertension', 'Musculoskeletal stiffness', 'Tachycardia']",2,PFIZER\BIONTECH,IM 928675,,37.0,F,"Night sweats, intermittent sweating for three days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/05/2021,4.0,WRK,None,None,None,,None,"['Hyperhidrosis', 'Night sweats']",UNK,PFIZER\BIONTECH, 928676,CA,57.0,M,"Extreme fatigue, upset stomach, vomiting several hours after injection. Fatigue lasted 3-4 days, felt week and tired.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"Lisinopril, Statin.",None,HTN,,NKDA,"['Abdominal discomfort', 'Asthenia', 'Fatigue', 'Vomiting']",1,MODERNA,IM 928677,TN,28.0,F,Fever Chills Body ache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,Levothyroxine Lisinopril,No,Hypothyroidism,,No,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 928678,TX,56.0,F,"Moderna COVID-19 Vaccine EUA I had chills, low grade fever of 99.4 initially, fatigue, lightheaded and felt like I was moving in slow motion. As the evening progressed, I felt worse and worse, had no appetite, very slight nausea, but no vomiting. During the night, my fever went up. I only checked it once and it was 100.1, but I was having severe chills, my knee joints were aching, as well as some of my fingers. The next morning I had a headache, and was dizzy (which may have been from not eating the night before). The symptoms continued throughout the day, but were managed fairly well with Tylenol. Additionally, my arm was extremely sore. It hurt to move it in any way. Even worse arm pain than with a Tetanus shot, which has always caused me a great deal of pain. Thankfully the symptoms only lasted about 28 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Synthroid, Rosuvastatin, Singulair, Zyrtec, Flonase, Omeprazole, Vitamin D3, Vitamin B12, Juice Plus Vitamins, Co-Q10",None,"Hypothyroidism, Prone to UTI's, due to rt. ureter smaller than left from birth with re-implantation of ureter done as a child, seasonal allergies, high cholesterol",,IVP dyes,"['Arthralgia', 'Chills', 'Decreased appetite', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Headache', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 928679,NC,57.0,M,accute Pancreatitis,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PUB,,,Diabetes,,Oysters,['Pancreatitis acute'],UNK,MODERNA,SYR 928680,CT,39.0,F,"At the 10-hour mark after receiving my second dose, I developed a blotchy rash on my chest and neck (no discomfort or itching). At the 12-hour mark I developed severe chills and body aches and exhaustion which came on very quickly. At (approx.) the 13-hour mark my temperature was 103.3 but it never got any higher than that. For the next 24 hours my temperature hovered around 101-102.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,"Buproprion, Lamictal, Concerta, multi-vitamin, Biotin, calcium +D",None,None,,NKDA,"['Chills', 'Fatigue', 'Pain', 'Pyrexia', 'Rash macular', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH,SYR 928682,OK,52.0,F,"On 1/6/2021 rash, redness, hot, itching, hematoma to injection site. Night sweats. Nausea. Side effects have not resolved at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,SEN,HCTZ,None,None,,Erythromycin,"['Injection site erythema', 'Injection site haematoma', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth', 'Nausea', 'Night sweats']",1,MODERNA,IM 928683,MA,41.0,F,Recipient reported a temp of 101.2,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,WRK,,,,,,['Body temperature increased'],2,PFIZER\BIONTECH,IM 928684,,49.0,F,"swollen around injection site/upper arm, warm to touch, redness and itchiness.",Not Reported,,Not Reported,Not Reported,,Not Reported,,,01/07/2021,,UNK,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 928685,KY,26.0,M,The day after the vaccine was given patient reports that he was sore and swollen at vaccine injection site. He also developed a headache later that day. He reports being able to use arm normally but it is still very sore. It was hot to the touch but is better now. He overall feels weak and tired and plans to see his PCP,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PUB,None,None,None,,Ritalin causes blood pressure to drop.,"['Asthenia', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity']",1,MODERNA, 928686,MN,55.0,F,"HA starting for 1 hour after injection, lasted for 24-26 hours despite Advil, Excedrine and Fiorocet Abdominal cramps with diarrhea starting 4 hours later, lasted another 4 hours (I get diarrhea very rarely)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"vitamin D, BP medication, Prilosec",none,high BP,,"PCN, Vicryl suture","['Abdominal pain', 'Diarrhoea', 'Headache']",1,PFIZER\BIONTECH,IM 928687,TX,25.0,F,"Pain and swelling at the site of the injection Heachaches, low grade fever, and muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PUB,Levothyroxine Lo-Lo Estrien,,Hashimottos,,,"['Headache', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 928688,OK,67.0,M,"Numbness, drooping mouth and nose area.....Bells Palsy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,PUB,Metoprol Lamactil Seroquel,None,No,,None,"[""Bell's palsy"", 'Hypoaesthesia']",2,PFIZER\BIONTECH,SYR 928689,,50.0,F,"Initial soreness x 3 days then: 12/29/20: itchy with a lump present, 12/30/30: worsening symptoms, redness measures 4cm x 2cm and the induration is 5 cm x 5cm, warm. No fever",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/12/2020,12/30/2020,18.0,UNK,Gabapentin B Complex Omega 3 fatty acids (OTC fish oil),None,Migraine Lyme neuropathy,,Apples Celery oil (anaphylaxis) Carrots (anaphylaxis) Parsley (anaphylaxis),"['Erythema', 'Induration', 'Mass', 'Pain', 'Pruritus', 'Skin warm', 'Tenderness']",1,MODERNA,IM 928690,TX,55.0,F,"01/07/2020 11:00AM 1in red mark on injection site, warm to touch, mild itch and slightly raised. Fever 103. Mild headache Follow up with PCP and red mark has increased in size 1 1/2in in size.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,"Metoprolol 50 mg , Trokendi, Vitamin D 5,000, Estradiol patch Pepcid, Zyrtec, progesterone 200, nortriptyline 40 mg",,"High blood pressure, migraines",,"Latex , Skelaxin","['Headache', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pyrexia']",1,MODERNA,IM 928692,TX,53.0,F,"Patient complained of restless, heart racing, anxious, felt like her blood pressure was up (did not take BP meds this morning) after immunization. Patient checked out by EMS. Patient advised to call 911 or go to the nearest emergency room for any additional issues as needed. Also advised to sign up for v-safe. Patient left site after being seen by EMS.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PUB,,,,,,"['Anxiety', 'Palpitations', 'Restlessness']",1,MODERNA,IM 928693,CA,27.0,F,"Injection site is red hot to touch Headaches going on for a week, since the injection",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,UNK,,,,,,"['Headache', 'Injection site erythema', 'Injection site warmth']",1,MODERNA,SYR 928694,NE,98.0,F,"AT 10:50 AM (5 MINUTES POST VACCINATION), FELT LIKE 'HEAD IS FILLING UP, MY LIPS ARE PUFFY, AND I HAVE NUMBNESS UNDER MY EYES AND NOSE'. RECEIVED BENADRYL 12.5MG AT 10:59AM. CONDITION RESOLVED BY 11:15AM. MD WAS NOTIFIED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,,,,,,"['Head discomfort', 'Hypoaesthesia', 'Lip swelling']",1,PFIZER\BIONTECH,IM 928695,IL,39.0,F,"Decreased range of motion, numbness and pain requiring pain medications more than one week after administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/03/2021,4.0,PVT,"Multivitamin, magnesium, probiotic, Vitamin D3",Strep Throat.,Obese,,None,"['Hypoaesthesia', 'Mobility decreased', 'Pain']",1,MODERNA,IM 928696,TN,48.0,F,"Approx 10 hrs after injection- headache and nausea, 12 hrs severe chills/fever x4 hrs then sweating x2 hours. Resolved at 24 hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PUB,"Zyrtec, Benadryl, gabapentin",none,"allergies, back problems",,sulfa,"['Chills', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pyrexia']",1,MODERNA,IM 928697,CO,34.0,F,"Pain at injection site and fatigue about 5 hours after injection, nothing I wouldn't consider ""normal"". Mild headache and nausea started 10 hours after injection. Took 1000mg Tylenol and went to bed. Nausea, fever symptoms w/ no fever, pale, extreme fatigue started the next morning. Took 1000mg Tylenol, attempted to go to work, went back home and back to bed to rest.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Nexplanon Fluoxetine 40 mg Phentermine 37.5 mg Topirimate Methimazole 2.5 mg,,Chronic Depression - under control by meds Graves Disease - under control by meds,,"Nickel, adhesive, mercapto mix","['Fatigue', 'General symptom', 'Headache', 'Impaired work ability', 'Injection site pain', 'Nausea', 'Pallor']",1,MODERNA,IM 928698,VA,45.0,F,"I have developed an itchy rash a week after my injection with raised papules on my hands, wrists, arms and upper legs. The site of my injection has a large (half-dollar size) red rash that is itchy and slightly raised. A visual examination by 2 providers that I work with (Family Practice office) today due to extreme itching. I was instructed to take Ranitidine and Zyrtec at approximately 9am. It is now 12pm and the itchiness is a little better.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,,None,None,,None,"['Injection site rash', 'Papule', 'Rash erythematous', 'Rash papular', 'Rash pruritic', 'SARS-CoV-2 test negative']",1,MODERNA,IM 928699,,52.0,F,"First dose of Pfizer COVID-19 vaccine administered to this individual. She reported dizziness and head feeling ""fuzzy"". Had patient drink water and juice. VS were BP 137/90 HR 91. She stated her HR routinely runs in the 90s. Observed her for greater than 30 minutes. Symptoms didn't worsen. She was awake, alert with a steady gait. Patient was released to home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,WRK,,,,,Sumatriptan (Chest tightness),"['Dizziness', 'Feeling abnormal']",1,PFIZER\BIONTECH,IM 928700,GA,24.0,F,"Rash. Large teardrop shape, red and risen up from the skin around the injection site. If I touch it, I notice that it?s itchy. Just noticed it this morning after showering, can?t think of any other reason for it to be there and there?s not any rashes elsewhere on my body. Currently icing it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/08/2021,9.0,SCH,Advil liquid gels prn Loratidine 10mg qd Sambucus gummies 2qd,None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling']",1,MODERNA,IM 928701,CA,68.0,F,Extreme acid stomach. Can on the night of the vaccine and nausea the next day. I still have the stomach acid.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,Calcium and multivitamin magnesium.,None,None,,,"['Dyspepsia', 'Nausea']",1,PFIZER\BIONTECH,SYR 928702,KY,26.0,F,"Patient reported expanded red petechia (red spots) on bilateral lower extremities including feet and knee area. Patient got CBC and went to PCP. CBC was normal except platelets low-normal 150,000. No itching, swelling, etc. This occurred about 9 days after vaccination. Improved gradually and mostly normalized 3 weeks out when receiving 2nd dose of vaccine. No other symptoms reported besides sore arm for 2 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/27/2020,9.0,PVT,Multivitamin,"Viral infection (fever, chills) 12/1/2020 - COVID negative",Petechaie intermittently on shins of both legs,,None,"['Full blood count normal', 'Pain in extremity', 'Petechiae']",1,PFIZER\BIONTECH,IM 928703,PA,64.0,F,"Pt. states that she developed nausea and vomiting for one day, no treatment, resolved on 01/06/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,denies,denies,denies,,penicillin-anaphylaxis,"['Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 928704,NM,42.0,F,"BP: 120/70 - Lightheadedness, syncope. Outcome: rested, stabilized.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,,,,,,"['Dizziness', 'Syncope']",1,PFIZER\BIONTECH,IM 928705,IL,30.0,F,"I developed nausea the night of the vaccine, the next morning I woke up with a headache behind my eyes, and fainted while getting ready for work that morning. I then had a really bad headache and slept the entire day. I was unable to go to work or care for my house or children.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PUB,none,none,none,,none,"['Headache', 'Impaired work ability', 'Nausea', 'Syncope']",1,MODERNA,IM 928706,VA,55.0,F,"Chil,bodyache, headache upset stomach",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,SEN,"Levothyroxine, omeprazole dr",None,None,,None,"['Abdominal discomfort', 'Chills', 'Headache', 'Pain']",1,PFIZER\BIONTECH,SYR 928707,CA,22.0,F,"Moderna COVID?19 Vaccine Chills (approximately 4 hours), muscle and joint ache (approximately 12 hours), fever (approximately 8 hours), syncope and ears ringing (momentary)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,None,None,None,,None,"['Arthralgia', 'Chills', 'Myalgia', 'Pyrexia', 'Syncope', 'Tinnitus']",1,MODERNA,IM 928710,AR,37.0,F,"Chills, Dizziness, Night Sweats, Headache, Nausea, Body Aches, Weakness, Fatigue and Joint Pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PHM,"Prenatal Vitamins, Microgestin, Biotin and Airborne",,,,Sulfa,"['Arthralgia', 'Asthenia', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Night sweats', 'Pain']",1,PFIZER\BIONTECH,IM 928711,CA,58.0,F,Red hot patch 4 x 2 inches on L arm Arm soreness for a week,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,UNK,,,,,,"['Pain in extremity', 'Rash macular']",1,MODERNA,SYR 928712,AZ,40.0,F,"0920 VAC. ; 0930: AFTER VAC. SHOT- NAUSEA/VOMITING, ""FOGGY FEELING""; 0930: VS: BP: 145/90, P: 89; T: 98.3 DEG. F; 02 SAT: RA: 97%; 0948: VS: BP: 129/82, P: 85, O2 SAT: 98 %R.A.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Feeling abnormal', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 928715,,63.0,F,"unable to sleep, photo sensitive, lack of appetite and migraine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/29/2020,1.0,UNK,,,,,,"['Decreased appetite', 'Migraine', 'Photosensitivity reaction', 'Sleep disorder']",1,MODERNA,SYR 928716,CT,50.0,F,Sore arm at the injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,"buspirone, fluoxetine, quetiapine, clozapine",Bi-Polar,Bi-polar,,,['Injection site pain'],1,MODERNA,IM 928717,CA,44.0,F,"Sxs started 15 minutes post vax, difficulty breathing, rash. Sent to ED. Sxs resolved by 12/29/2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/26/2020,0.0,PVT,,,,,,"['Dyspnoea', 'Rash']",1,PFIZER\BIONTECH,IM 928718,,35.0,F,"Patient complained of itching on back of neck and behind ears. Denied shortness of breath, difficulty breathing, rash or sweating. 25 MG IM Benadryl administered at 1019. Patient watched for 15 minutes following Benadryl administration. Patient denied any symptoms following.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PVT,,,,,,['Pruritus'],1,PFIZER\BIONTECH,IM 928719,VA,42.0,F,"Approximately 4 days after vaccine, employee noticed soreness and swelling in the armpit on the left side. This lasted about 4 days but got progressively better. On day 8 she noticed redness on her skin the size of a quarter that was not sore, itchy or warm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/02/2021,4.0,PVT,Lexapro,none,none,,Percocet,"['Axillary pain', 'Erythema', 'Oedema peripheral']",1,MODERNA,IM 928720,TX,37.0,F,"Patient complained of being lightheaded, headache, felt like BP was elevated after immunization. Patient checked out by EMS, began feeling better shortly thereafter. Patient advised to call 911 or go to the nearest emergency room for any additional issues as needed. Also advised to sign up for v-safe. Patient left site stating he felt better.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PUB,,,,,,"['Blood pressure increased', 'Dizziness', 'Headache']",UNK,MODERNA,IM 928721,ND,21.0,F,"Fever, body aches, very sore arm, headache, fatigue for 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/19/2020,1.0,UNK,Cryselle birth control,None,None,,None,"['Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 928722,CA,65.0,F,"Sxs 5 minutes post vax with tingling in LUE, but vaccine given in RUE. Tingling is persistent. No improvement. Persistent sxs.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/26/2020,0.0,PVT,,,,,,['Paraesthesia'],1,PFIZER\BIONTECH,IM 928723,WV,35.0,F,>Sore arm - Days 1 to 2 - Resolved without intervention >Gas/Diarrhea - Days 1 to 7 - Resolved without intervention >Engorged breasts - Days 3 to 5 - Resolved without intervention >Sore/uncomfortable (lump) under arm - Days 3 to 7 - Mostly resolved (no current intervention) >Red raised rash (nickle-sized and about 5 inches below injection site) - Days 8 to 9 - Mostly resolved (no current intervention),Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,PHM,"Synthroid 75mcg Lessina Women's One-A-Day Multivitamin Vitamin D 2,000iu",,Hashimoto,,Sulfa Latex,"['Breast engorgement', 'Diarrhoea', 'Pain in extremity', 'Rash erythematous', 'Rash papular']",1,MODERNA,IM 928724,,46.0,F,"Progress Notes COVID VACCINE CLINIC Subjective Patient is a 46 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. � She denied any history of previous adverse reactions to vaccines. � She was given the Moderna vaccination in the right deltoid muscle. � During her 15 minute waiting period after the injection, the patient began to experience increased breathing rate following right shoulder/clavicle pain. She denied rash, hives, welts, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. � This provider was notified of patient reaction and she was then assessed in the emergency bay area. � Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality and respiratory distress with increased work of breathing. � � � � ALLERGY REVIEW OF SYSTEMS: Patient complains of shortness of breath ( most likely from mild anxiety) and muscle aches � � Previous Reactions: none � Objective � Vitals Vitals: � 01/07/21 1136 01/07/21 1146 BP: (!) 140/92 129/70 BP Location: Right arm Right arm Patient Position: Sitting Sitting Cuff Size: Regular Adult Regular Adult Pulse: 88 76 Resp: 14 12 SpO2: 100% 100% � Physical Exam Vitals signs reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Head: Normocephalic and atraumatic. Right Ear: Hearing and external ear normal. Left Ear: Hearing and external ear normal. Nose: Nose normal. Eyes: General: No scleral icterus. Right eye: No discharge. Left eye: No discharge. Conjunctiva/sclera: Conjunctivae normal. Neck: Musculoskeletal: Normal range of motion and neck supple. No neck rigidity or muscular tenderness. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. No murmur. No friction rub. No gallop. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Chest: Chest wall: Tenderness ( right mid clavicle) present. Musculoskeletal: Normal range of motion. Skin: General: Skin is warm and dry. Neurological: Mental Status: She is alert and oriented to person, place, and time. Sensory: No sensory deficit. Gait: Gait normal. Psychiatric: Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. � � � Assessment/Plan Treatment included: avoidance measures and talking with the patient.. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. � Patient was thought to have a mild muscle spasm from the injection that may have cause a mild anxiety attack. Patient was fully cooperative the whole time and appreciative for team of medical staff. Patient's symptoms quickly resolved and she was able to leave without assistance. Patient declined assistance to her car. � � � �",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,"['Anxiety', 'Dyspnoea', 'Injection site pain', 'Injection site reaction', 'Muscle spasms', 'Musculoskeletal chest pain', 'Myalgia', 'Respiratory rate increased']",UNK,MODERNA, 928725,NC,37.0,F,"06 Jan 2021 @1336: Presented to ED about 15 minutes after vaccine with complaints of nausea, vomiting, chills, and chest tightness. During this visit, she received IV fluids, Benadryl and Zofran by mouth.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,MIL,"Rizatriptan, Klonopin, Trazodone, Wellbutrin, D3",,"BH issues, IBS",See VAERS #227223,NKA,"['Chest discomfort', 'Chills', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 928726,AL,32.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Adverse event: nausea, chills, injection site pain, tiredness, headache, muscle pain, feeling unwell Treatment: APAP 1000mg Q6Hrs Time course: injection site pain started ~3hrs after receiving vaccine; chills, headache started ~11-12hrs after vaccine; muscle pain, feeling unwell, nausea, tiredness started ~17-18hrs after receiving vaccine; majority of symptoms improved 48hrs after vaccine administration; some tiredness and feeling unwell remain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Wellbutrin XR 300mg daily One-a-day Prenatal vitamin Levothyroxine 25mcg QAM,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,IM 928727,OH,28.0,F,"Sudden extreme fatigue and mild nausea for about 2 hours. Then felt tachycardia and palpitations. Heart rate was checked by medical professional in household and was found to be 120 and irregular. This lasted approximately 2 minutes. At this time also felt shortness of breath which lasted 30 minutes. Once the tachycardia and shortness of breath ended, I was getting chills and continued to have nausea and extreme fatigue. Since the vaccination my arm has continued to be very sore. When I woke up on 1/8/2021 I am still very fatigued and still have a sore arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"Tylenol, Ibuprofen",None,exercise induced asthma,,Allergy to sulfa medication,"['Chills', 'Dyspnoea', 'Fatigue', 'Heart rate irregular', 'Nausea', 'Pain in extremity', 'Palpitations', 'Tachycardia']",1,MODERNA,IM 928728,FL,36.0,M,"Moderns COVID-19 Vaccine EUA Chills, Aching, Fatigue, Fever, Headache, Dizziness, Blurred vision",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Pain', 'Pyrexia', 'Vision blurred']",1,MODERNA,IM 928729,CT,48.0,F,"Client c/o tightness in throat 8 minutes after receiving Dose 1 of Moderna vaccine. Pulse 90,O2 sat.96,BP 150/110.Bendryl 50 mg po given,after10 minutes client c/o worse tightening of the throat,paleness and red raised rash noted on both arms and chest. Epi pen administrated O2 sat 98, pulse 80, BP 120/90. EMS called . Client transported to Hospital via ambulance.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,WRK,"Amnilyloadiadapine103F, severe diaphoresis. Most acute reaction lasted 8-12 hours. Sub-acute reaction of mild fever, generalized ache, and malaise 48 hours post. I am a health care provider, Certified Registered Nurse Anesthetist (CRNA).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,,none,none,,Sulfa Antibiotics,"['Chills', 'Hyperhidrosis', 'Malaise', 'Nausea', 'Pain', 'Pyrexia', 'Tachycardia', 'Tachypnoea', 'Tremor']",2,PFIZER\BIONTECH,IM 929655,FL,40.0,F,"After receiving the vaccine, I went into a waiting room for the post-vaccine 15 minute observation. Approximately 2 minutes after sitting down I felt a sensation that can be described as a wave through my body. It only lasted for 10 seconds; however, it was immediately followed by a rapid heartbeat. It almost felt as though I might pass out (I have never passed out before). I alerted a nurse, and she monitored me for the 15 minute duration. After about 2 minutes, I felt 'normal' again.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PUB,OMEPERAZOLE,NONE,FATTY LIVER,,"SEPTRA , ALL SULFA DRUGS AND TOPICAL CREAMS","['Dizziness', 'Feeling abnormal', 'Heart rate increased']",1,MODERNA,SYR 929656,IA,25.0,F,"Patient called and said she felt weak, her temp was 99.1, she was going from having chills to being hot, and it hurt to touch her body. I instructed the patient to call the CDC hot line at 1-800-232-4636",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,SEN,unknown,unknown,unknown,,unknown,"['Asthenia', 'Chills', 'Feeling hot', 'Pain']",1,PFIZER\BIONTECH,IM 929657,PA,35.0,F,"I started a little dizzy after the vaccine but could have been my cycle. Later that evening my arm was soar and swollen. I didn't take anything, a little difficult to sleep. The next day it started wearing off, I did ice the area.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,WRK,Excedrin (24 hrs prior to vaccine),,Sjogren's syndrome,,,"['Dizziness', 'Insomnia', 'Pain in extremity', 'Peripheral swelling']",1,PFIZER\BIONTECH,SYR 929659,MN,47.0,F,"Within 45 minutes, my neck and face became hot and red. No issues with breathing, 6 hours later, I received a rash over the arm in which I had the injection. Since the shot Monday, I have continued to have redness on neck and face and along with felling hot. I have been taking Benadryl since Monday and finally went to UC on Thursday 01/07/2021. At the appointment, I received a Decadron injection, which helped, but today I am back to red face/neck and warmth.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Inderal, Maxalt, Ibuprofen, Prilosec",No,Diverticulosis,,"Codeine, Sulfa","['Erythema', 'Feeling hot', 'Rash', 'SARS-CoV-2 test negative', 'Skin warm', 'Streptococcus test negative']",1,PFIZER\BIONTECH,IM 929660,AR,58.0,F,"2-3 minutes after the vaccination I developed a very fast heart rate, had a strange taste in my mouth, and for a brief second I thought my throat would close in. I was immediately taken to the ER and monitored for about 2 hours. During that time I had about 4 episodes of my heart rate going very high. I was told 120-150 beats/m. I was also told that I had PVC's and PAC's. I was released after 2 hours and had another episode of a fast heart rate on my way home. Since then I have had daily episodes of fast heart rate but not as long and not as intense. Last episode was 2 days ago.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,"Metoprolol , Omeprazole, Ambien, Vitamin C, Fish Oil, B12, Milk Thistle, Probiotics, Magnesium, Co Q10",no,"Spinal Stenosis, Hypertension",,"Dairy, Cow's Milk, Corn, Mold, Mildew, Dust Mites","['Blood creatine phosphokinase', 'Blood thyroid stimulating hormone', 'C-reactive protein', 'Differential white blood cell count', 'Electrocardiogram', 'Full blood count', 'Heart rate increased', 'Laboratory test', 'Red blood cell sedimentation rate', 'Renal function test', 'Supraventricular extrasystoles', 'Taste disorder', 'Throat tightness', 'Troponin I', 'Ventricular extrasystoles']",1,MODERNA,IM 929661,MN,58.0,F,dry cough started-1/6/2021 7:30pm-now deep bronchial cough overall muscle and joint achiness started 1/7/2021 5pm low grade fever (99.9) 1/7/2021 at around3pm nausea and diarrhea 1/8/2021 11am general malaise-started 1/7/2021 early morning,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,tyelnol PM omeprazole multi vitamin calcium supplement vit D trazadone hydroxazine,none,Ulcerative colitis,,nka,"['Arthralgia', 'Cough', 'Diarrhoea', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,IM 929662,ME,32.0,F,"One week after receiving vaccine my right deltoid was swollen, red and warm to the touch with heavy arm and discomfort down whole arm. This lasted several days. Treatment was antihistamine and ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,WRK,"Sertraline, xyzal, and Gianvi birth control",,,,"Penicillins, dust mites, percocet, sulfa antibiotics","['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Limb discomfort']",1,MODERNA,IM 929663,WI,27.0,F,"On friday 1/1 around 10 pm I developed some chills. Saturday morning 1/2 I woke up feeling like I was hit by a bus, I had body aches, muscle aches, fatigue, chills, fever, headache and sore throat. Throughout the day I took 1000mg of tylenol every 8 hours, 2000mcg of vitamin C and Zinc two times per day. My fever got as high as 102.1. Sunday I woke up feeling slightly better, but not much. Fever of 100 throughout the day with same course of treatment. Monday 1/4 I was feeling better, I did not have a fever but still had some fatigue, headache and a sore throat. Tuesday I was feeling improved just had fatigue and no appetite. By wednesday 1/6 I was feeling back to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,WRK,None,None,None,,None,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Myalgia', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",UNK,MODERNA,IM 929665,OH,53.0,M,"Headache, chills, night sweats, body aches, slight fever. Lasted from Tuesday at 11:00 pm to Thursday early morning 5:00am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,none,"['Chills', 'Headache', 'Night sweats', 'Pain', 'Pyrexia']",1,MODERNA,IM 929666,,35.0,F,"About 2:00 a.m. on 1/8/21, patient experienced diahhrea about 4 - 5 times during the night; vomited twice; injection site is sore; has severe nausea (8/10 scale); pateent has taken nothing for the symptons. The diahhrea and vomiting lasted until about 7:30 a.m.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Type II Diabetes: Humalog / insulin, Toujeou/insulin, Ozempic, Glimeperide, Lysinapril, Rosuvestatin, Zetia",tested Covid positive on 12/07/20,"Diabetes, hypertension",,No,"['Diarrhoea', 'Injection site pain', 'Nausea', 'Vomiting']",1,MODERNA,IM 929667,PA,58.0,F,"12 hrs post injection awoke with shaking chills with fever eventually 102. 2 more episodes of lesser chills in next 12 hrs, with gradual decrease in fever over 24 hrs to low grade 99. Had severe body aches/joint pains during this time which also slowly improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"Omeprazole, losartan, nature's valley multivits",none,"Peptic ulcer disease, HTN",,"Anectine, duramorph, latex","['Arthralgia', 'Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 929668,TX,43.0,F,"FATIGUE, MALAISE, INJECTION SITE PAIN, VERTIGO, HYPOTENSION",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,None,None,None,,None,"['Fatigue', 'Hypotension', 'Injection site pain', 'Malaise', 'Vertigo']",1,PFIZER\BIONTECH,IM 929669,WA,49.0,F,"Caregiver complained of a ""heavy"" throat and had redness and itching to her neck and chest area",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,unknown,none reported,none reported,,none reported,"['Erythema', 'Oropharyngeal discomfort', 'Pruritus']",2,PFIZER\BIONTECH,IM 929670,NY,22.0,F,"After vaccination, she reported to the ER. She stayed in observation for about 4 hours. States about 20 minutes afterward developed some sensation of tightness in her throat, upper chest pain, and some dizziness. Patient has a history of allergic reactions and in the past has had anaphylaxis she does carry a EpiPen. Patient took Benadryl prior to vaccine this morning and then again afterwards a total of 50 mg, did not notice any swelling of her face tongue or lip, there is no wheezing or difficulty breathing not noticed any rash or hives. Received Famotidine, methylprednisolone and IV fluids when in the ER. The next morning she was found be Covid Positive and they did not know it previous.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,See page 2,unknown,"Asthma, allergic rhinitis, depression, gerd, scoliosis, vit d deficiency",,"phenylephrine, sulfa, shelfish, blue, green, purple dye, rabbi","['COVID-19', 'Chest pain', 'Dizziness', 'SARS-CoV-2 test positive', 'Throat tightness']",1,MODERNA,IM 929671,NM,50.0,M,"Patient reported severe nausea, body aches, and chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PHM,,,,,,"['Chills', 'Nausea', 'Pain']",1,MODERNA,IM 929672,CT,48.0,F,"A week after receiving dose 1 of the Moderna COVID19 vaccine, I developed a red, raised, hot, itchy circle of about 1 1/2 inch diameter at my injection site. I took 2 Benadryl that evening. The next morning, I took a non-drowsy 24 hours anti-histamine. The red area continued to grow larger. Now, 9 days after the injection, the area is the size of a softball and is still hot, red, raised and itchy. It reminds me of the reactions I would get when I received allergy shots, except those reaction I had within 24 hours of getting my allergy shot instead of being delayed for a week. On day 9 post-vaccination, I also developed a red, itchy area of about 1 inch diameter on my back.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,None,None,Chronic venous insufficiency,,"Thimerosal, carrots, celery, apples, peaches, cherries, tree & weed pollen, dust mites, hazelnuts","['Erythema', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pruritus']",1,MODERNA,SYR 929674,TX,65.0,F,"Hives over neck, chest Benadryl 50mg PO",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,Hypothyroidism,None,,None,['Urticaria'],1,MODERNA,IM 929675,FL,,U,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,,,MIL,,,,,,['Unevaluable event'],1,MODERNA,SYR 929677,CO,81.0,M,"Patient presented to the emergency department with generalized body aches (head, abdomen, and chest) and nausea. Patient did not experience respiratory distress. Patient was given IV NS bolus and discharged home is stable condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,WRK,,,,,"Aspirin (bleeding), NSAIDs (bleeding)","['Nausea', 'Pain']",1,MODERNA,IM 929678,KS,49.0,F,Sore Throat Hard to Swallow Throat hot Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/22/2020,1.0,PVT,amlodipine 5mg Netoprolol Gabapentin Dulozetine,None,Low immunize system,Taltz Injection -,None,"['Dysphagia', 'Headache', 'Oropharyngeal pain', 'Streptococcus test']",1,PFIZER\BIONTECH,IM 929679,,40.0,F,"Body aches, chills, sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Chills', 'Pain', 'Pain in extremity']",1,MODERNA,IM 929680,ME,31.0,F,Paresthesias on right thigh. Feels like pins and needles or a cold ice pack applied and sensation moves from hip down to knee. Repeats multiple times daily everyday since vaccination. Occasional tingling and weakness in forearms and wrists bilaterally.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/03/2021,3.0,WRK,"Acetaminophen, Aviane",none,Post COVID-19 infection 10/2020,,"crab, shrimp, scallops (eye and tongue swelling)","['Feeling cold', 'Muscular weakness', 'Paraesthesia']",1,MODERNA,IM 929681,NE,32.0,F,"ON 1/4/21 AT 4:00PM, DEVELOPED DIZZINESS, CHEST TIGHTNESS, 'HEAVY' ARMS AND LEGS, HEADACHE, HYPERTENSION (DBP>100). WAS GIVEN 25MG DIPHENHYDRAMINE AT 4:25PM. SENT TO ER AT 5PM. REPORTS SHE WAS SENT HOME FROM ER AT 7:30PM WITH A DIAGNOSIS OF DEHYDRATION. PATIENT REPORTS SHE TAKES A NUMBER OF PSYCHOTROPIC DRUGS, INCLUDING VYVANSE, FLUOXETINE, AND WELLBUTRIN. SHE IS CURRENTLY ON A KETO DIET AND TOOK NAPROXEN EARLIER IN THE DAY.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,,,,,,"['Chest discomfort', 'Dehydration', 'Dizziness', 'Headache', 'Hypertension', 'Limb discomfort']",1,PFIZER\BIONTECH,IM 929683,FL,93.0,F,"Labored breathing with oxygen running at 4l/min, muscle weakness",Not Reported,,Not Reported,Yes,,Not Reported,U,01/06/2021,01/07/2021,1.0,SEN,"Levothyroxine, Lisinopril, Metoprolol, Prozac, Trazadone","Pneumonia, UTI with ESBL","A-Fib, Cardiomegaly, HTN, CHF, HLD, Hypothyroidism",,NKA,"['Dyspnoea', 'Muscular weakness']",1,PFIZER\BIONTECH,IM 929684,,53.0,F,"patient reports nausea, body aches and headaches and fatigue, sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,WRK,,,,,,"['Fatigue', 'Headache', 'Nausea', 'Pain', 'Pain in extremity']",UNK,MODERNA, 929685,MD,38.0,F,*Moderna* Headache that has lasted 3 days along with a stiff neck on the left side.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,,,"prednisone, morphine","['Headache', 'Musculoskeletal stiffness']",UNK,MODERNA,IM 929686,FL,31.0,M,"After administration of the first dose of the COVID19 vaccine (Pfizer) intramuscularly to the left deltoid, the patient experienced right hand tingling.� Patient was monitored for 30 minutes, at which point symptoms had resolved. This patient received his second dose of vaccine (from same lot # EH9899) on 1-6-20201 and no adverse reactions were displayed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,PVT,None Known,None Known,None Known,,None Known,"['No reaction on previous exposure to drug', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 929687,OH,41.0,F,The patient stated that her arm started itching and began to swell. Suggested she try Benadryl and if symptoms began to spread or worsen go to the ER.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PUB,Metoprolol and Atenolol,None,Heartburn,,Prednisone- increased blood pressure,"['Peripheral swelling', 'Pruritus']",1,MODERNA,IM 929688,VA,43.0,F,"I'm the safety pharmacist who is reviewing my ADR reports. Unsure if pt or provider also reported. Per the documentation in the database visit ""Received COVID-19 vaccine made by Moderna on 12/28/2020 and starting yesterday she developed body aches fever to 101. Starting this morning she started having blisters on her hands on the sides of her fingers and she also noticed that the inside of her lips are peeling. �She is not short of breath. She does not have chest pain. She does not have a rash on other parts of her body at this time. Her tongue is not swelling. She has no vaginal mucosal symptoms. PE Mouth-the inside of her lips on video look very irritated and slightly sloughing. I see no other ulcers in the mouth. Small blisters on the bilateral hands with mild erythema."" �",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/30/2020,2.0,UNK,,,,,Wellbutrin [bupropion Hcl]- Hives,"['Blister', 'Cheilitis', 'Erythema', 'Lip exfoliation', 'Pain', 'Pyrexia']",1,MODERNA,IM 929689,CA,61.0,M,"Fever to 103.7F, respiratory rate 36. Was transferred from facility to hospital. Since then has been found to have gram-negative rod bacteremia, although urinalysis was negative, urine culture pending. Patient has since defervesced after receiving 1 dose of cefepime. Overall the most likely cause of fever seems to be urosepsis w/ bacteremia, pending confirmation with urine & blood cultures.",Not Reported,,Yes,Yes,,Not Reported,Y,01/06/2021,01/07/2021,1.0,SEN,"HCTZ, losartan, carvedilol, aspirin",none,"h/o multiple strokes, vascular dementia (bedbound, unable to speak) trach for h/o resp failure, G-tube/tubefeed dep",,amlodipine (gum swelling),"['Bacteraemia', 'Blood culture', 'Blood lactic acid', 'Culture urine', 'Full blood count', 'Laboratory test', 'Liver function test', 'Pyrexia', 'Respiratory viral panel', 'SARS-CoV-2 test negative', 'Urine analysis normal', 'Urosepsis']",2,PFIZER\BIONTECH,IM 929690,LA,55.0,F,Facial flushing,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,none,none,none,,none,['Flushing'],4,MODERNA,IM 929691,OK,48.0,F,"Patient complained of being dizzy and then suddenly developed headache and chest tightness approximately 10-15 minutes after vaccine (Moderna) given. Blood pressure 152/100, pulse 89 bpm, 98% O2 room air, and 18 resp. Cot was brought over and client placed in lying position. Blood pressure 144/108, pulse 82 bpm, and 18 resp. Patient remained alert and oriented. Patient spoke to staff appropriately. EMS arrived at 1405 - Report given, patient transferred via stretcher to ambulance.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,Unknown,Unknown,Unknown,,Unknown,"['Chest discomfort', 'Dizziness', 'Headache']",1,MODERNA,IM 929692,NY,33.0,F,"Redness, bump under the skin, pain at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/08/2021,2.0,WRK,"Prenatal multivitamin, vitamin D, elderberry",Sinus Infection 3 weeks prior,None,,None,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 929694,OH,26.0,F,"The evening of 1/7/21 she developed a temp of 100.3 with body aches, and rash on bilateral arms/ chest. Took Motrin at night and had mild temp on 1/8 of 99. and 99.2",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/08/2021,2.0,PVT,,no,no,,no,"['Body temperature increased', 'Pain', 'Rash']",1,MODERNA,IM 929695,DC,26.0,F,"Hives, started 24 hours after vaccine administration, present for about 1 week after vaccine dose, improved with antihistamine therapy. no lip/tongue swelling, shortness of breath, vomiting, syncope, hypotension",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,,none,history of proteinuria,,none,['Urticaria'],1,PFIZER\BIONTECH,IM 929696,WA,26.0,F,"About ten hours after the injection, started having severe chills, N/V, severe headache, dizziness, fever, severe muscle soreness, active loss of smell and taste. General malaise and weakness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,,,"Asthma,",,"Percocet, watermelon","['Ageusia', 'Anosmia', 'Asthenia', 'Chills', 'Dizziness', 'Headache', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 929698,PA,56.0,F,Severe vision blurriness. Unable to distinguished a red light from a green light. It went away 24 hours later.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PUB,no,no,no,,no,"['Dyschromatopsia', 'Vision blurred']",UNK,MODERNA,IM 929699,NC,26.0,F,"lightheadedness, pulse increase to 112 bpm, temperature increase, headache/migraine, blurry vision.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,SEN,UNKNOWN,UNKNOWN,UNKNOWN,,UNKNOWN,"['Body temperature increased', 'Dizziness', 'Headache', 'Heart rate increased', 'Migraine', 'Vision blurred']",1,MODERNA,SYR 929700,NC,38.0,F,Pfizer-BioNTech COVID-19 Vaccine EUA. Burning in the arm during vaccination and after,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,None,,,,Codeine,"['Immediate post-injection reaction', 'Injection site pain']",1,PFIZER\BIONTECH,IM 929701,KY,32.0,F,"Severe lethargy, muscle aches/pains, and fever (101.2F) starting about 12 hours post vaccine. Fever reached a max of 105.4F at one point but generally held around 102.2F without use of Acetaminophen. Symptoms started subsiding around 36 hours post vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Mirena IUD,none,none,,no known allergies,"['Lethargy', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 929702,TX,35.0,F,"arm swelling, headache ,tired, chest tightness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,NONE,NONE,NONE,,NONE,"['Chest discomfort', 'Fatigue', 'Headache', 'Peripheral swelling']",1,MODERNA,IM 929703,ID,59.0,F,"Headache within 5 minutes. Within 3 minutes stomach pain, stiffness/tightness, stiffness/tightness in extremities legs, calves, arms, stomach, neck, all over tightness/stiffness. Dizziness, slight blurry vision, fuzzy feeling. All these symptoms persisted for 1 full week, with slight relief after 1 week, but continuing into second week.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,Gabapentin,none,heart burn GERD,,none,"['Abdominal pain upper', 'Chest discomfort', 'Dizziness', 'Feeling abnormal', 'Headache', 'Muscle tightness', 'Vision blurred']",1,MODERNA,SYR 929704,CO,82.0,F,"After first dose of Moderna COVID-19 vaccine, patient started to experience dizziness and lightheadedness. Patient was given water/juice and observed. Patient was discharged to home in stable condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,WRK,,,"Skin cancer (2017), Chronic renal insufficiency, glaucoma, peripheral vascular disease, hypothyroid, hypertension, hyperlipidemia, angina,",,"Nitrofurantoin (shortness of breath, rash, hypotension), Neosporin (irritation), Sulfa, Fentanyl (lightheadedness, vomiting, nausea)",['Dizziness'],1,MODERNA,IM 929705,PR,52.0,F,"LEFT AXILLARY PAIN AND EDEMA, GENERALIZED WEAKNESS AND MUSCLE PAIN WAS UNABLE TO GET OUT OF BED",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,"VITAMIN C, D3, B COMPLEX, LASIX, COREG, ASA 81MG, LIPITOR",VIRAL SYNDROME,"CHF, HTN, MIGRAINE, CAD",,QUINOLONES,"['Asthenia', 'Axillary pain', 'Bedridden', 'Myalgia', 'Oedema']",2,PFIZER\BIONTECH,IM 929706,FL,66.0,F,"For a few days after vaccine, arm was very sore then that stopped. A week after the vaccine, injection site felt itchy and then became red and hot (about a 2"" square around the injection site). That has continued for 2 days so far. I took a Benadryl on the 2 day and the redness subsided some.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PUB,"Levothyroxine, Vit D, Calcium, Multi-vitamin, echinachea",none,none,"Sore arm for 2-3 days after other vaccines (flu, shingles, hepatitis)",Penicillin,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 929707,PR,20.0,F,Patient present some flushing after vaccine administration,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,No,Unknown,Unknown,,Unknown,['Flushing'],1,PFIZER\BIONTECH,IM 929709,TX,28.0,F,"Had typical fever, chills, body ache & headache first 24 hours after vaccine. 48 hours later arm got red, hard and swollen below injection site. was painful to touch. a few hours that had splitting headache and neck pain and stiffness. had lab work done- all normal. took prophylactic antibiotics. arm was itchy now better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,PVT,"OTC Iron, Prenatal Vitamin, Zinc",had covid . tested positive 12/14/2020,,,NKDA,"['Chills', 'Erythema', 'Headache', 'Induration', 'Laboratory test normal', 'Musculoskeletal stiffness', 'Neck pain', 'Pain', 'Peripheral swelling', 'Pyrexia', 'Tenderness']",1,MODERNA,IM 929710,TN,64.0,F,"on day 10 after the vaccine my L arm got red and hot and about the size of a half dollar, now it is day 13 and the redness is larger about 3x5 in size still red and hot and a bit sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/05/2021,10.0,PUB,"trulicity,metformin,lisonipril,baby asprin,zoloft,nexium",no,diabetic type 2,,no known allergies,"['Erythema', 'Pain in extremity', 'Skin warm']",1,MODERNA,IM 929711,IA,25.0,F,"Starting in the evening on 1/6/21, night sweats and a severe headache that was not relieved with OTC meds. Signed off work on 1/7/21 due to symptoms. Fever of 100.6 that has resolved. 1/8/21 chills and sweats alternating throughout the day along with body aches and swollen lymph nodes, making it difficult to swallow.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,,,,,,"['Chills', 'Dysphagia', 'Headache', 'Hyperhidrosis', 'Lymphadenopathy', 'Night sweats', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 929712,CA,61.0,F,Soreness Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Headache', 'Pain']",1,PFIZER\BIONTECH,SYR 929713,CA,61.0,F,"25 minutes after shot started having tightness in my throat, then heart pounding. Pulled into ER on my drive home. Received medications, prednisone, benadryl and pepcid and was observed a few hours. Ok now. Still glad I got vaccine since I am in health care.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,"pepcid, zyrtec, multiple vitamin, magnesium",no,"allergies, asthma, arthritis, osteoporosis, glaucoma",,no,"['Palpitations', 'Throat tightness']",1,MODERNA,IM 929714,NJ,50.0,F,"Had vaccine on 1/4. On 1/7, redness developed around vaccine site. It's sore, itchy, bruised and warm to the touch but not raised. Pt marked site on 1/7 AM and on 1/8, it's still the same size.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/07/2021,3.0,PVT,"MVI, vitamin D",None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Vaccination site bruising', 'Vaccination site pain', 'Vaccination site warmth']",1,MODERNA,IM 929716,WA,42.0,M,"complaints of a headache, right side face swelling and numbness, and right sided chest pain",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,unknown,not reported,unknown,,not reported,"['Chest pain', 'Headache', 'Hypoaesthesia', 'Swelling face']",UNK,PFIZER\BIONTECH, 929717,PA,45.0,F,"1/6/2021: Started around 9:30pm with fever, Chills, Headache and body aches 1/7/2021: Continues with same symptoms mentioned above including nausea. Fever range from 101 - 102.4 Continued to take Tylenol and hydrate 1/8/2021: No fever in am. Started with a slight fever around 2:00pm at 99.5",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,None,Vasovagal Syncope,,None,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 929720,,30.0,F,Employee reports hair 6 days post vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/24/2020,6.0,UNK,,,,,,['Hair disorder'],1,PFIZER\BIONTECH,IM 929721,RI,49.0,M,"flushing, hypertension, tachycardia, cold, clammy",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,none reported,none,none,,none,"['Cold sweat', 'Feeling cold', 'Flushing', 'Hypertension', 'Tachycardia']",1,MODERNA,IM 929722,IA,34.0,F,Patient experienced fingers and toes swelling. Patient also has tightness in throat.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,SEN,,,,,,"['Peripheral swelling', 'Throat tightness']",1,PFIZER\BIONTECH,IM 929723,NY,92.0,M,"SOB, WEAKNESS, ABNORMAL VITAL SIGNS, UNRESPONSIVE VERBALLY",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,SEN,tamsulosin 0.4 mg capsule Eliquis 2.5 mg tablet Lantus Solostar U-100 Insulin 100 unit/mL (3 mL) subcutaneous pen finasteride 5 mg tablet Neurontin 100 mg capsule Namenda 10 mg tablet Depakote 250 mg tablet zinc sulfate 220 mg (50 mg) capsu,NONE,DM2 HTN BPH ALZHEIMER'S DISEASE,,NKA,"['Asthenia', 'Dyspnoea', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 929726,IL,43.0,M,"Fever, body aches, Mental fogginess",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,none,none,none,,NKA,"['Feeling abnormal', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 929727,IN,45.0,F,1st 3 days sore arm and red area about inch wide. This went away now day 9 large swollen red hard area making whole arm hurt,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,WRK,"Tamoxifen, metoprolol, synthroid, flecainide and omeprazole",None,"Hypothyroid, high blood pressure, he of breast cancer 2 yrs ago",,Only to adhesive like bandaids and tape,"['Erythema', 'Induration', 'Pain in extremity']",1,MODERNA,SYR 929728,NJ,44.0,F,"Got vaccine on the 23rd, on 25th got fever, chills, headache, and this happened for four days. Had shingles at the same time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/01/2021,9.0,WRK,Prozac,Shingles.,,,,"['Blood electrolytes normal', 'Chills', 'Condition aggravated', 'Full blood count normal', 'Headache', 'Herpes zoster', 'Laboratory test normal', 'Pyrexia', 'SARS-CoV-2 test negative']",UNK,MODERNA, 929729,CT,83.0,M,Rash on forehead and left eye swollen shut started the day after injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,High blood pressure,,,"['Eye swelling', 'Rash']",1,MODERNA,SYR 929730,SC,44.0,M,Immediately after injection I had no pain. I went to get tested and was positive for Covid.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/23/2020,2.0,PVT,"Nasal spray, multi-vitamins",None reported,None reported,,None reported,"['COVID-19', 'Immediate post-injection reaction', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 929731,KS,40.0,F,"Noted severe fatigue, diffuse pain, facial twitching on eye and mouth r side first day. Second day fatigue, and diarrhea, headache Third day-today abdominal pain, GI bleed",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,OTH,,N/a,Dx: autonomic nervous system dysfunction from Clinic a about 4 years ago,,"Sensitive to gluten, dairy and soy No food allergies that cause anaphylaxis Seasonal allergies","['Abdominal pain', 'Diarrhoea', 'Fatigue', 'Gastrointestinal haemorrhage', 'Headache', 'Muscle twitching', 'Pain']",1,MODERNA,SYR 929732,TX,57.0,F,"Pt report body aches, headache and fever of 101.5. Treated with Tylenol with mild improvement",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 929733,NC,45.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA, Itching that started about 3 minutes",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,,,,,"Peanuts, shell fish",['Pruritus'],1,PFIZER\BIONTECH,IM 929734,MD,46.0,F,"Chest tightness, headache, runny nose, mild cough.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,WRK,,,,"chest pain, age 46, December 2020 , COVID",Morphine,"['Chest discomfort', 'Cough', 'Headache', 'Rhinorrhoea']",2,PFIZER\BIONTECH,IM 929735,TX,49.0,F,"Eight days following the receipt of the vaccine in my right arm, I had pain, redness and mild swelling around the injection site. I marked the area with a marker and used ice and ibuprofen. However, the following morning, the redness and swelling had worsened, and I had fever up to 101.8. I was seen by a physician on Web that morning (1/1/2021) who diagnosed me with cellulitis and prescribed a 7 day course of Reflex. The symptoms improved within a day, and I have since completed the course with complete resolution.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,PHM,"Methimazole, Valtrex, Mutivitamin, Ultra-Mg, Vitamin D",None,"Hyperthyroidism, HSV",,None,"['Cellulitis', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Pyrexia']",1,MODERNA,IM 929736,UT,24.0,F,"Sore throat, swollen tonsils, head ache, dizziness, stomach pains",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,PVT,Cleanse more digestive vitamin,Sore throat,None,"Flu vaccine - sore throat, head ache, body aches",None,"['Abdominal pain upper', 'Condition aggravated', 'Dizziness', 'Headache', 'Influenza virus test negative', 'Oropharyngeal pain', 'SARS-CoV-2 test negative', 'Streptococcus test negative', 'Tonsillar hypertrophy']",1,MODERNA,SYR 929737,OH,35.0,F,"On 1/7/21 this individual called in to report that after her vaccine on 12/30/20 she noticed a lump under her skin at injection site that eventually went away. A few days later it returned and she reports it's itchy, reddened, and continues getting bigger. She tried Benadryl and ice with no results. I encouraged her to call her family doctor to see if they had any further recommendations.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,PUB,,,,,,"['Injection site erythema', 'Injection site mass', 'Injection site pruritus']",UNK,MODERNA,IM 929738,CT,46.0,F,"5 plus days of low grade temp, intermittent flushing, headache, body aches, tiredness . On day 7, left deltoid site became swollen within 2 hours to the size of a small baseball , red, tingling and painful- occupational health ordered covid test as well",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,Estrogen patch and lansoprazole,None,"GERD, total hysterectomy",,"Sulfa, latex, PCN","['Fatigue', 'Flushing', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site paraesthesia', 'Injection site swelling', 'Pain', 'Pyrexia']",1,MODERNA,IM 929739,CA,46.0,M,"Chills, body aches, head aches,fever and felt dizzy",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/01/2021,01/08/2021,7.0,PVT,None,None,None,,None,"['Dizziness', 'Feeling cold', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 929740,IL,59.0,F,"Very tired, nausea, extremely sore left arm, drained of energy. Unable to work the next day. Left arm a little itchy. Took Benadryl , slept and then felt better. Did fine with first shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,"Imgality injection once monthly Topamax 25 mg am, 75 mg pm Omeprazole 40 mg am Sudafed 10mg am Imodium 1/2 tab am Flonase 1 squirt each nares am",None,Mycobacterium Avium complex in lungs- being followed by pulmonologist.,,EES- Nausea Bactrim- sores down throat/ mouth,"['Asthenia', 'Fatigue', 'Impaired work ability', 'Nausea', 'Pain in extremity', 'Pruritus']",2,PFIZER\BIONTECH,SYR 929741,CA,36.0,F,"Patient came to the event and stated that she had amoxilin allergy. she had discussed with her doctor regarding the vaccine and decided to proceed. Given the allergy back, she was placed in the observation area closest to the clinical team. The team checked on her 5 mins after the dose and she said she was okay. At 10 minute mark, patient started feeling week and had rapid breathing. Help was called immediately. On site physician placed her flat on the ground. Vitals were checked with SBP 137. Her neck started showing rashes. On site physician ordered a dose of diphenhydramine 25mg PO and was administered approximately at the 20 mins mark. Patient was still weak but was responsive to all commands. Epipen was NOT given. Patient was taken to the clinic for further observation. Stable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,doctor on site gave diphenhydramine 25mg PO,unknown,unknown,,amoxicillin,"['Asthenia', 'Rash', 'Respiratory rate increased']",1,MODERNA,IM 929742,CO,72.0,F,"After first dose of Moderna COVID-19 vaccine, patient started to experience pruritus at the injection site. Patient then reported previous itching reaction to vaccines (not noted which vaccine). Patient was given 12.5 mg diphenhydramine at 1105 and then observed. At 1110 patient noted minimal itching and there was no redness/swelling at the injection site. Patient was monitored and discharged home at 1132.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,WRK,,,,unknown which vaccine/when,"Iodine (diarrhea, vomiting, rash), sulfa (blistering), Bacitracin (rash, itchy/watery eyes), betadine (rash), ceftriaxone (diarrhea), codeine (rash), penicillin (diarrhea), adhesive tape (rash)",['Injection site pruritus'],1,MODERNA,IM 929744,NV,68.0,F,"1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight headache, eyelid drop-bi-lat. Lasted 30 minutes. Day 2- symptoms returned approx 10:30 am - 3:00 pm. Nore intense included dizziness, shakes, overall malise, chest tightness. Later that day, mild diarrhea, mikd nausea. Day 3- woke with wheezing. Symptoms all continued for next 10 days off and on. The lip, tongue seemed to get shorter and shorter in duration. Also has mouth watering. Afternoon would bring on overall malaise issues. 2nd and 5th day, the worst. On 3 day went to urgent care, prednisone 40 mg x days, pepcid, zyrtec. Back to urge t care day 6, Ed day 8. Day 14 abd 15 awful chills, muscke ache and shaking.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,PVT,"Levoxyl .88 daily, lio-thronine .5 Bid, flovent 110 2 puffs bid. Vit D3 4000 daily, magnesium citrate 250 daily.",None,"Asthma- controlled, thyroid.",,None,"['Chest X-ray normal', 'Chest discomfort', 'Chills', 'Diarrhoea', 'Dizziness', 'Electrocardiogram normal', 'Eyelid ptosis', 'Headache', 'Laboratory test normal', 'Malaise', 'Musculoskeletal discomfort', 'Myalgia', 'Nausea', 'Paraesthesia oral', 'Salivary hypersecretion', 'Tremor', 'Wheezing']",UNK,PFIZER\BIONTECH,SYR 929747,CA,58.0,F,Severe arm pain. Unable to open and close fingers. Back hurts Chills Cough,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,"['Back pain', 'Chills', 'Cough', 'Mobility decreased', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 929748,FL,48.0,F,"Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, malaise, myalgia, dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,"vitamin D 1000u, zinc, vitamin C 500, multivitamin",no,thyroid nodule,,Tapazole,"['Dizziness', 'Erythema', 'Malaise', 'Myalgia', 'Nausea', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Tenderness']",2,PFIZER\BIONTECH,SYR 929749,OK,26.0,F,Unknown,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,Unknown,Unknown,Unknown,,Unknown,['Unevaluable event'],1,MODERNA,IM 929750,IL,32.0,F,"Sore at injection site on day of vaccine, day2 - woke up in early AM achey & chilled. During the day continued with fever of 101.7, extreme arm pain (hard to move arm), muscle aches, chills, fever max of 104.1. Injection site swollen, warm, painful with pain radiating down arm. Day 3 slight headache, fever of 100.6, injection site still red & swollen but better. Day 4 PCP consulted, advised to use cool or warm compresses to arm. Day 5 injection site slightly swollen, a little warm.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PVT,,,,,,"['Chills', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Mobility decreased', 'Myalgia', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 929751,MT,33.0,F,Large rash around injection site starting one week post vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PUB,"Restasis, prenatal vitamins, sublingual allergy drops",none,none,,Azithromycin,['Injection site rash'],1,MODERNA,IM 929752,PA,40.0,F,"Employee woke with sensory disturbance on left side of face itchy sensation, left eyelid and bottom lip droop, left ear pain. She was ordered steroids by her PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,"Zoloft, Buspar, Multivitamin",None reported,None reported,,Penicillin,"['Ear pain', 'Eyelid disorder', 'Lip disorder', 'Pruritus', 'Sensory disturbance']",UNK,PFIZER\BIONTECH,IM 929753,PA,30.0,F,Fatigue; chills; low-grade fever; muscle aches; nausea; headache; mental fogginess,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,IM 929754,OR,32.0,F,"The first day after my vaccination, my range of motion was limited in my right arm. The second day after vaccination, my right deltoid was sore. The next few days, I had no issues or reactions. 8 days after my vaccination my right deltoid began to itch and when I looked at it there was a patch of redness, which was swollen and warm to touch. The redness went half way around my deltoid, but did not include the injection site. I applied ice, took aleve. Over the following 30 hrs, the symptoms dissipated.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/06/2021,8.0,UNK,,,,,,"['Injected limb mobility decreased', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 929755,PR,26.0,M,EVALUATED IN EMERGENCY ROOM BY DR. WHO ASSESSED PATIENT AND RECOMMENED LORATADINE 10MG DAILY AND GILTUSS EVERY 6 HR FOR COUGH (Evaluated in emergency room by Dr. who assessed patient and recommended loratadine 10mg daily and giltuss every 6 HR for cough),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,no,no,no,,benadryl,['Cough'],2,PFIZER\BIONTECH,IM 929756,CA,50.0,F,"For the first 3-4 days following administration the site was red, raised and hot. It also appeared that placement of the injection was SubQ tricep area instead of IM at biceps. Site was clear from day 5-10. On day 10, site was red, hot and tender. Primary care physician informed.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/08/2021,9.0,PVT,Levothyroxine Ibuprofen,None,Hypothyroidism Sjogrens Cutaneous lupus Migraines,"Site tenderness, redness, heat and swelling",NKA,"['Incorrect route of product administration', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 929759,NY,28.0,F,"2 hours after receiving the vaccine, patient noticed blochiness on chest and fever. Last 2 hours and the went away.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,COVID infection 10 days prior to vaccination (last day of syptoms on 12/27th),No,,Penicillin - Hives,"['Electrocardiogram', 'Pyrexia', 'Rash macular']",1,PFIZER\BIONTECH,IM 929760,OR,42.0,M,New erythema area on left deltoid. Area covers most of deltoid area and is slightly warm to the touch. Patient stated he noticed it this am.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/08/2021,9.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,IM 929761,,44.0,F,Patient experience feeling of throat closing 60 minutes after administration.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,WRK,Celebrex Losartan Epi pen Topamax,None known,Hypertension Migraine,,Shrimp Iodine,['Throat tightness'],1,MODERNA,IM 929762,OH,26.0,F,"Developed chills, muscle aches and unable to lift her arm with injection site the evening of her shot. She had to call off work on 1/8/21",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,no,no,,,"['Chills', 'Impaired work ability', 'Injected limb mobility decreased', 'Myalgia']",1,MODERNA, 929763,LA,51.0,F,"Nausea, headache, chills, and body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,none,none,none,,none,"['Chills', 'Headache', 'Nausea', 'Pain']",5,MODERNA,IM 929764,WA,45.0,M,The patient was found deceased at home about 24 hours after immunization. Date of Death:: 12/29/2020; estimated time of death 6:00pm,Yes,12/29/2020,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,"Hydrochlorthiazide (by record, not confirmed)",,"Hypertension, sleep apnea, obesity. based on medical record",,no known allergies recorded in medical record,['Death'],1,MODERNA,IM 929765,KY,28.0,F,Patient experienced numbness and tingling around 15min after dose was received.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,"Buspar, ergocalciferol, lo loestrin, paxil",,generalized anxiety,,"Latex, Latuda, Amben","['Hypoaesthesia', 'Paraesthesia']",UNK,PFIZER\BIONTECH,IM 929766,,37.0,F,Neuropathy in vaccinated arm a few minutes after receiving vaccination. Resolved within an hour.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,['Neuropathy peripheral'],2,PFIZER\BIONTECH,SYR 929767,NY,39.0,F,"Rash following first dose Second dose: rash, fatigue, body aches, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,Benadryl due to rash following first dose,None,None,,Severe Allergy to penicillin,"['Fatigue', 'Pain', 'Pyrexia', 'Rash']",2,PFIZER\BIONTECH, 929768,NE,63.0,F,"EVENING OF 12/30/20, DEVELOPED BODY ACHES AND NAUSEA THAT LASTED APPROXIMATELY 12 HOURS.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,,"['Nausea', 'Pain']",1,PFIZER\BIONTECH,IM 929769,OK,54.0,F,"Fatigue ,chills,headache, nausea,lightheaded",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,Hydroxyzine,None,asthma,,penicillin,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Nausea']",UNK,PFIZER\BIONTECH, 929770,PR,28.0,M,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,none,none,none,,Iodine,['Unevaluable event'],1,PFIZER\BIONTECH,IM 929771,NY,32.0,F,"Chills s/p covid vaccine. Denies nausea, dizziness, light headedness, CP, or abdominal pain. No treatment required.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,,,,,,['Chills'],1,PFIZER\BIONTECH,IM 929772,AK,56.0,F,"Raspy voice, hives on lips, itching at mucus membranes. Started around 1/6 at 1500 and carried over to around 0900 on 1/7. Client states she is used to this kind of reaction and managed it the same way she does with other reactions. 50mg Benadryl in two 25mg doses 6 hours apart, 10mg singulair, and her daily 20mg of prednisone. She did have an epi-pen on hand, but did not use (no difficulty breathing, no swelling in throat or mouth).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,"20mg prednisone, 40 mg lisinopril, both daily. Client states she often pre-medicates with 25mg Benadryl prior to vaccinations, just in case.",Client states none.,"Crohn's disease, hypertension, both managed","Anaphylactic reaction to a tetanus vaccine approximately six years ago. Client did not state brand name, just that it was a teta","Latex, including bananas and avocados, ciprofloxacin, Humira, Remicade, Entyvio, and tetanus vaccinations - all anaphylactic reactions","['Dysphonia', 'Pruritus', 'Urticaria']",1,MODERNA,IM 929773,TN,29.0,F,"At time of injection, left arm was sore and small welt appeared that went away after about 3 days. On 1/6/2021 I noticed a welt at injection site that was hot and felt hard. Welt has continued to spread on arm, some elbow and arm pain on left arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,PVT,Pregabalin 150mg x3 Yaz .02mg Trazadone 50mg Tizanidine 4mg Synthyroid .025mg Meloxicam 15mg Methocarbamol 750mg Women?s multivitamin Biotin Probiotic B12,None,RSD Thyroid problems Anemia,,None,"['Arthralgia', 'Injection site induration', 'Injection site reaction', 'Injection site warmth', 'Pain in extremity', 'Urticaria']",1,MODERNA,SYR 929774,,31.0,M,I felt fine the rest of yesterday but started to feel really tired and worn down late last night. I took my sleeping pill like normal and went to bed. I woke up feeling really achy and cold so I went to take some Tylenol in case I had a fever. Started feeling dizzy and light headed and I passed out. I cut my foot on the glass I dropped and scraped my back as I fell. I don?t remember being blacked out very long. I just remember sitting on the floor feeling really lethargic. My whole body felt tingly and my ears were ringing really bad. Was able to get up and get back to bed. Decided to go back to sleep and not go to the ER. This morning I?m still a little dizzy but mostly just have a headache and am extremely tired. I plan to get into my doctor today so I will keep you updated. Just wanted to let you know what happened so you could report it.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,,,Migraines,,,"['Dizziness', 'Fall', 'Fatigue', 'Headache', 'Lethargy', 'Limb injury', 'Loss of consciousness', 'Pain', 'Paraesthesia', 'Skin abrasion', 'Tinnitus']",1,PFIZER\BIONTECH,IM 929775,OK,69.0,F,"Nausea, Chills, Muscle pain, tired",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PUB,"Multi Vitamin, Sertraline, estrodial, Vitamin D 50,000 once a week",no,none,,no,"['Chills', 'Fatigue', 'Myalgia', 'Nausea']",2,MODERNA,SYR 929776,NJ,61.0,F,Vaccine was erroneously injected too high on arm approximately one fingerbreadth below acromion so it was not placed in the deltoid muscle as intended. Therefore the immune response will not be optimal and shoulder injury could develop.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,"Pravastatin, Losartan, levothyroxine, metformin","Hypertension, Hypothyroid, Hashimoto's thyroiditis,Increased cholesterol, borderline diabetes, obesity",see above,,mome,['Product administered at inappropriate site'],1,MODERNA,SYR 929777,CA,20.0,F,Pt complaining of dizziness and SOB and had mild hives at injection site and posterior shoulder. Pt was given Benadryl IM and transported to hospital by paramedic ambulance.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,SEN,None,None,None,,Codine,"['Dizziness', 'Dyspnoea', 'Injection site urticaria']",1,MODERNA,IM 929778,CA,62.0,F,"Shoulder pain in injection site , not able to raise shoulder. Tingling in fingertips",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,WRK,Regular vitamins and anastrozole,,,,,"['Injected limb mobility decreased', 'Injection site pain', 'Paraesthesia']",UNK,MODERNA, 929779,OH,66.0,F,"Had Moderna vaccine on Dec, 30, 2020. starting 1/5/202 feeling lightheaded, blood pressure high, chills off and on, no fever, redness at the site of the shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PVT,"Levothyroxine 100 mg 1vx daily, Monelukast SOD10 mg 1x daily, Valacyclovir HCL 500 mg 1x daily, Bayer Asprin 81 mg 1x daily, Flovent HFA 110 mg 2 puffs 2xs daily, Ventolin HFA rescue inhaler 90 mg as needed, Nasacort 24 hour 2xs daily, CVS","Thyroid {Hypo}, Cholesterol, Asthma, seasonal allergies, Arthritis.",same as above question #11,,"no, but Bendral makes me overly sleepy.","['Chills', 'Dizziness', 'Hypertension', 'Injection site erythema']",1,MODERNA,IM 929780,IN,24.0,F,"On January 7th all of my symptoms began. 7:30am: woke up feeling uneasy. Not much of a headache or no fever. 12:30: woke up from nap. Severe body aches (with sharp stabbing like pain accompanying them. Chills, severe headache . All of these symptoms accompanied me all night long. 3:30pm: I finally got a thermometer and had a fever of 100.7 which I then took 1000mg of Tylenol which helped. 7:30pm: body aches start coming back 9:30pm: headache, chills are back with a fever fever of 100.3 Took another 1000mg of Tylenol. 3:30pm: woke up from sleep to take more Tylenol, physically felt better. No fever was present and my temperature was back to 98.8. January 8 2:00pm: feeling back to normal essentially just tired. I have been sleeping a lot too with this vaccine..",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"I take Estrella which is a birth control, I also take a citalopram.",None,None,,None,"['Anxiety', 'Chills', 'Fatigue', 'Headache', 'Hypersomnia', 'Pain', 'Pyrexia']",1,MODERNA,IM 929781,IL,62.0,F,"103.5 temp, headache, fatigue. The temp broke after 24 hours and can back the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,"Omeprazole, amlodipine, synthroid, metformin, Lexapro, prem-pro, vit b12, probiotic",H-plyroic,"Htn, diabetic, gerd, hypothyroidism",,Vancomycin and other antibiotics,"['Body temperature increased', 'Fatigue', 'Headache']",1,MODERNA,IM 929782,MS,53.0,F,"received injection at 1015am; approx 1 1/2 hrs after receiving experienced extreme tiredness, dizziness, nausea, headache and muscle aches. towards the evening, started having joint pains and stomach pains. at approx midnight i had a migraine and at 3 am work up with joint and muscle pain and stomach pain along with nausea. on day 2 i had all the above symptoms. on day 3 i had some muscle ache. i mainly took acetaminophen extend release tablets",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,"cymbalta, lunesta, remeron, wellbutrone, calcium carb &vit d, spirolactone, adalate, acetaminophen extended release tablets. womens 50+ multi vitamin, vit b complex, metformin",none,"diabetic, raynauds, obesity, obstructive sleep apnea, depression, insomnia",,cipro,"['Abdominal pain upper', 'Arthralgia', 'Dizziness', 'Fatigue', 'Migraine', 'Myalgia', 'Nausea']",1,MODERNA,IM 929783,CO,55.0,F,"Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and had general body aches, which has continued into 1/8/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,SEN,N/a,N/a,N/a,,N/a,"['Feeling hot', 'Haemorrhage', 'Pain', 'Swelling', 'Urticaria']",1,PFIZER\BIONTECH,IM 929784,AR,56.0,F,"Unable to urinate after the injection with presentation next day to the Hospital ER on 12/19/2020. On evaluation, an in/out catheterization was required to empty the bladder with 1 liter output. She then was discharged home. She is a nurse and had to self catheterize once more prior to being able to urinate spontaneously. She is currently experiencing UTI symptoms of dysuria and urgency.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/18/2020,0.0,UNK,,,,,,"['Bladder catheterisation', 'Dysuria', 'Micturition urgency', 'Urinary retention', 'Urinary tract infection']",1,PFIZER\BIONTECH,SYR 929785,CO,53.0,F,"After second dose of Pfizer COVID-19 vaccine, patient started ""feeling weird"" and ""washed over"". Patient denied dyspnea, nausea, DM/hypoglycemia issues, known heart issues, swelling/itchiness, adverse event with first vaccine, and no adverse event to previous other vaccines. Patient had eaten lunch, but just come off of a shift and thought she might be dehydrated. Water was provided to the patient. Patient stated that she had intermittent lightheadedness/dizziness. Patient denied performance of vasovagal maneuver. Patient also experienced tachycardia and was clammy. Cool pack was provided to patient. Clinical course below: 1530 145/81, 105, 97%, 15 1535 119/81, 88, 96% 1540 126/75, 87, 96% 1542 pt felt another wave of lightheadedness, HR 103 1546 126/79, 90, 96% 1551 128/80, 91, 96% 1555 140/60, 79, 96% 1559 110/84, 87, 97% 1600 pt reports new scratchy throat 1602 25 mg Benadryl administered by RN 1603 discussed with Pharm D 1605 131/77 91, 97% 1611 145/79, 95, 98% Pt finished 12 oz of water and 4 oz of juice 1615 pt reports throat feeling better 1615 118/62, 69, 96% 1630 109/95, 99, 97% Pt stuck out tongue, no evidence of edema 1621 127/72, 84, 97% �At 1642, patient was discharged to family's care and taken home.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,WRK,,,,,"Aspirin (facial swelling), ibuprofen (facial swelling), NSAIDs (facial swelling), penicillins","['Cold sweat', 'Dehydration', 'Dizziness', 'Feeling abnormal', 'Oropharyngeal discomfort', 'Tachycardia']",2,PFIZER\BIONTECH,IM 929786,CA,50.0,F,"Patient experienced chills, fever, cramping, diarrhea, hypotension, weakness, fatigue and dizziness at approximately 12 am on 1/8/2021 at her home. Patient is recovering at home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PHM,None.,None,"Asthma, migraine headaches",,"Bactrim, Cipro, Penicillin","['Asthenia', 'Chills', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Hypotension', 'Muscle spasms', 'Pyrexia']",1,MODERNA,IM 929787,OH,35.0,F,1/6/2021 3:30 PM RECEIVED VACCINE 4:00 PM ONSET OF RASH/CHEST HEAVINESS 4:30 PM TOOK BENADRYL 25 MG PO AND PEPCID 20 MG PO 6:00 PM TOOK 2ND DOSE OF BENADRYL 25 MG PO 6:30 PM IMPROVEMENT OF RASH/CHEST HEAVINESS 1/7/2021 9:00 AM ONSET OF FATIGUE/MALAISE/INJECTION SITE PAIN/CHEST HEAVINESS 1/8/2021 9:00 AM MALAISE/INJECTION SITE PAIN,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,MIGRAINES,,"IMITREX, CIPRO, NUBAIN","['Chest discomfort', 'Fatigue', 'Injection site pain', 'Malaise', 'Rash']",1,MODERNA,IM 929788,NY,37.0,F,Reported itchy face covered with hives and one over eyelids very swollen. She was prescribed prednisone and symptoms resolved. Provided pictures in the email. She said her doctor advise not to take 2nd dose.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,,,,,,"['Pruritus', 'Swelling of eyelid', 'Urticaria']",1,PFIZER\BIONTECH,SYR 929789,VA,49.0,F,"Received first vaccine on 12/22/2020. 1/7/21 I developed symptoms of head congestion, headache and loss of taste & smell. 1/8/2021 tested positive for Covid.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/07/2021,16.0,PVT,"Prescriptions: Hydrochlorothiazide, bupropion HCL, naltrexone Dietary supplements: colon helper, turmeric curcumin complex",None,Hypertension Overweight,,No known allergies,"['Ageusia', 'Anosmia', 'COVID-19', 'Headache', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 929792,,47.0,F,"Patient developed headache almost immediately after vaccine administration that persisted with slight worsening. Her BP was found to be elevated 4 hours later to 180s/100s; on manual recheck, was 172/96. Given signs and symptoms consistent with hypertensive urgency, she was sent to the emergency room. She has a history of well-controlled HTN and has been adherent to her medications (including the day of vaccine administration); she has had no recent episodes of uncontrolled BP.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,"['Blood pressure increased', 'Headache', 'Hypertensive urgency', 'Immediate post-injection reaction']",1,PFIZER\BIONTECH,IM 929793,PA,53.0,F,"Felt severe itching pins needles on arms, wrists, chest & neck.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Prilosec, Topomax, Lipitor, Effexor, Asprin, Penicillin, vitamin B6, one women?s daily vitamin, vitamin B12",No,"Back pain, Anxiety",,CT Injectable dye,"['Paraesthesia', 'Pruritus']",2,PFIZER\BIONTECH,SYR 929794,PA,38.0,F,"The next morning I woke up and thought my mouth hurt then the more I thought about it I realized it didn't hurt but it was numb on the left side, like I had Novocain wearing off. It is getting a little better but is still numb a week later.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,"Mirena, Adderall, Strattera, Fish Oil, D3, CoQ10, Astaxanthin.",none,"Anxiety, ADHD",,none,"['Hypoaesthesia oral', 'Oral pain']",1,PFIZER\BIONTECH,SYR 929795,MN,36.0,M,"Arm sore within 5 hours, Headache within 10 hours that lasted for about 14 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,none,,none,,none,"['Headache', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 929796,OH,26.0,F,"Evening of shot she developed chills, muscle aches and can not lift her injected arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,no,no,,,"['Chills', 'Injected limb mobility decreased', 'Myalgia']",1,MODERNA,IM 929797,TX,65.0,F,Hives over Neck and Chest started after 5 minutes and resolved after 30 minutes of taking Benadryl 50 mg orally.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Euthyrox,None,Hypothyroidism,,None,['Urticaria'],1,MODERNA,IM 929798,MO,41.0,F,"I have no concerns about my reaction and did expect it but wanted to report for your information. I did report to v-safe. I had COVID-19 disease in September, so I was expecting to have a robust response to the vaccine. I received my Moderna vaccine on 12/29. I developed fever, shaking chills, and terrible body aches about 13 hours after the dose. I felt a bit better in the morning, so I went to work as usual but was still sore with body aches. I developed shaking chills, nausea, and worsening aches at lunch time and left work early because the nausea and chills were so significant. I slept the remainder of the day and by the morning of 12/31 felt well again. My symptoms probably lasted around 24-30 hours total. I did miss a half day of work but otherwise had no significant effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,PVT,,,,,Demerol,"['Chills', 'Impaired work ability', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 929799,GA,45.0,F,Moderna COVID-19 Vaccine EUA,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PUB,,,allergies,,,['Unevaluable event'],1,MODERNA,IM 929800,NJ,59.0,M,"Mild soreness at first. Next day, stomach started grumbling. Couldn't keep his eyes open, sweating,, weakness, abdominal pain, muscles aches, and vomiting this morning. no fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"Pentesa, Sertraline HCL, Mercaptopurine, Metronidazole, Metoprolol, Atorvastatin, Valsartan, Warfarin",no,Crohn's Disease,,no,"['Abdominal pain', 'Asthenia', 'Gastrointestinal sounds abnormal', 'Hyperhidrosis', 'Myalgia', 'Pain', 'Somnolence', 'Vomiting']",UNK,MODERNA,IM 929801,KS,48.0,F,"Pt started to feel dizzy after approx 15 minutes of receiving the vaccine, high blood pressure, swollen tongue, difficulty swallowing. EMS was called and pt was transported to hospital ER for further evaluation. Was released from hospital a couple hours later and feeling better since vaccine administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,,,,,,"['Dizziness', 'Dysphagia', 'Hypertension', 'Swollen tongue']",1,MODERNA,IM 929802,TX,50.0,F,Erythema and itching with cellulitis present at the injection site s/p injections 8 days later. Treatment with Keflex for 7 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PVT,None,None,None,,None,"['Injection site cellulitis', 'Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 929803,TX,42.0,F,"Initial Encounter: Per patient, she has had allergic reaction to sulfa drugs. When she took sulfa medication, she developed hives and tongue swelling. She denies having any respiratory or anaphylactic reactions. patient denies wanting to speak to her provider about getting the vaccine and has consented to get the vaccine today. patient is aware that she will be monitored for 30 minutes. 16:22: Patient is currently complaining of tongue tingling and concerns for tongue swelling. Patient escorted to room 11 with resource RN available. 1624: EE brought back to Obs room 11 for complaint of tingling to tongue. On assessment EE was alert and oriented, Sat probe placed and BP cuff, observed EE to have redness to chest and that continued to worsen as BP cuff placed. Clear to all lobes, no increased WOB. Per EE tongue felt tingley, no swelling observed to tongue, lips or face. VS obtained at 1624: HR 124, RR: 16, Pox: %99, BP: 159/102 tp Lt arm. Pt developed redness to Lt arm from elbow down to wrist. VS obtained again, HR: 114, RR: 16, Pox: %99, BP: unable to obtain as EE was moving arm. EE began complaining of increased itchiness in mouth and ""lip swelling"", writer and PCT both observed swelling to EE upper lip. Instructed to call 911, RN called back to Obs rm 11to assist. Epi pen administered to Rt quadricep at 1633, VS reassessed; HR: 116, RR: 16, Pox: %99, BP: 169/107 (126) Rt arm. Redness to Lt arm, chest and neck began to resolve and swelling to upper lip began to resolve, clear to all lobes. Dr. arrived to Obs rm 11 and was updated on events. EE remained alert throughout. EE's daughter notified via teams and was able to call and speak with her mom. EMS arrived and care transferred. Per EMS EE was to be transferred to Parkland. EE left on EMS stretcher with personal belongings. ~RN",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Unknown,None disclosed,None disclosed,,Sulfa,"['Erythema', 'Lip swelling', 'Oral pruritus', 'Paraesthesia oral']",1,MODERNA,IM 929804,IN,52.0,F,"Received vaccination the morning of 12/29/2020, experienced soreness in shoulder area. Hives began to swell at the injection site roughly 24 hours later. Red, circular, and raised but went away on its own. On 1/7/21 right eye began to swell below and above. Additionally, patient experienced aches in both shoulders, headache, and injection site raised again in hives through a 2x2 inch circle. left shoulder still feeling sore at the current time.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/30/2020,29.0,UNK,prescription medication,,high blood pressure,,allergy to a high blood pressure medicine called amodpehylne,"['Arthralgia', 'Erythema', 'Headache', 'Injection site pain', 'Injection site swelling', 'Injection site urticaria', 'Periorbital swelling', 'Skin swelling']",2,MODERNA,IM 929805,TX,16.0,F,"Patient is asymptomatic, but vaccine was given to a 16 year old, where manufacturer recommends 18 years and above.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Unknown,Unknown,Unknown.,,None reported from patient.,['Product administered to patient of inappropriate age'],1,MODERNA,IM 929806,CA,34.0,F,"Approx 30 minutes after vaccination, started feeling stomach upset, cramping. Approx 1.5 hours after vaccination, started feeling joint pain. Continued to work until the end of shift 1930. took Benadryl at 32130. Fell asleep; awoke next morning with aches; nasal congestion. Took Sudafed & came to work again (12/18/2020, 0700). Face started itching; then arms @t 0800 but continued working and finished shift. took Benadryl to relieve itching. Awoke early in morning to severe itching. Increased dose of Benadryl and fell asleep. Continued itching on Sat 12/19/2020 and having difficulty breathing. Used inhaler, Pepcid and Prednisone with good effect. Took off work Monday 12/21/2000, Tues 12/22/2020 and Wed 12/23/2020 (no meds taken). Returned to work on 12/24/2020, no fever, no exposure",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,birth control,conjunctivitis 11/2020; tested for COVID negative for in 11/2020,none,,"peanuts, walnuts. all nuts, bananas","['Abdominal discomfort', 'Abdominal pain upper', 'Arthralgia', 'Dyspnoea', 'Nasal congestion', 'Pain', 'Pruritus']",1,PFIZER\BIONTECH,IM 929807,CA,25.0,M,Slight fever and fatigue 12 hours post-vaccine injection,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Fatigue', 'Pyrexia']",1,MODERNA,IM 929808,NY,59.0,F,"Headache, fever, chills, back pain, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/06/2021,2.0,PVT,"Allegra, vitamin D, vitamin C","Severe pruritus, COVID-19, Fatigue",COPD,,"Sulfa, Macrodantin, Macrobid Diflucan","['Back pain', 'Chills', 'Fatigue', 'Headache', 'Pyrexia']",UNK,MODERNA,IM 929810,NJ,32.0,F,"Received 2nd dose of Covid vaccine on 1/6. On 1/7 at 0130 woke up with chills, severe headache, and body aches, but no fever. She took Advil, which helped but on 1/8 she still has headache and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 929811,NE,42.0,F,"ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, GOLF BALL SIZED RED AREA AROUND INJECTION SITE WHICH IS WARM TO THE TOUCH. AS OF THIS REPORTING IS AWAITING A CALL FROM HER PRIMARY PROVIDER.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,,,,,,"['Fatigue', 'Injection site erythema', 'Injection site warmth', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 929812,LA,51.0,F,none,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,none,none,none,,none,['Unevaluable event'],6,MODERNA,IM 929813,TN,76.0,F,PATIENT CALLED LCHD ON 1/6/21 TO REPORT REDNESS AND HEAT TO INJECTION SITE AT THIS TIME. PATIENT STATES THAT SHE TOOK BENADRYL AND WAS LIGHTENING UP IN COLOR.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/05/2021,13.0,PUB,NONE,NONE,NONE,,NONE,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,IM 929814,,51.0,F,"Pt states her arm was sore after she received the vaccine. She then experienced chills, joint pain, fever, and vomited when she returned home. On the following 2 days, Tuesday/Wednesday she had a fever between 100-102 F. By Thursday most symptoms had rectified, however she had a severe headache and abdominal discomfort. At time of my report (Friday), she states that the symptoms have mostly resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Abdominal discomfort', 'Arthralgia', 'Chills', 'Headache', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 929815,MA,60.0,F,Mild shortness of breath Severe bil lower extremity muscle spasms/cramps,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,WRK,,,Hypothyroidism HTN Asthma,,"NKDA , NKFA","['Dyspnoea', 'Muscle spasms']",2,PFIZER\BIONTECH,SC 929816,MO,26.0,F,"Employee here with COVID vaccine reaction was given the vaccine on 12/30/20 in left upper arm, noticed the area was red on 01/07/21. The area is red, swollen, warm to the touch, itching. The area measures 6 X 4.5cm borders not clearly defined. Explained conservative measures including cool compresses, if approved by PCP taking OTC IBU and antihistamines and hydrocortisone cream. Explained signs of cellulitis including skin tightness and red streaking, informed if the area worsens after trying conservative measure to go for further care with either PCP or walk in clinic. Employee verbalized understanding and agrees with plan.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/07/2021,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 929817,IN,47.0,F,Lymph node swollen under arm of injection site to the size of a golf ball also associated pain at lymph node site.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,"1000 mg omega 3 fish oil Tylenol , Naproxen, tramadol. Restasis / rhopressa / Travaprost / systane (otc)",,Fibromyalgia Glaucoma (POAG) Being treated for mild tbi -since 9-8-2020,,,"['Lymph node pain', 'Lymphadenopathy']",UNK,PFIZER\BIONTECH,IM 929818,CO,39.0,F,"1 week 1 day after vaccine. My arm started a small red spot and sore at injection site. Day 2 yesterday pain more noticeable, area larger, red, warm to the touch and noticed joint pain. Last night started body chills. This morning area very red, larger and more sore. Called pcp and was started on antibiotics",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,Ibuprofen Zyrtec Flonase,Severe sinus with headache for 2 weeks,Pre diabetic,,NKDA,"['Arthralgia', 'Chills', 'Injection site erythema', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 929819,OH,58.0,F,"12-24-2020 SOB, cough, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/24/2020,1.0,PVT,,,,,,"['Chills', 'Cough', 'Dyspnoea']",1,MODERNA,IM 929820,PA,39.0,M,"Hives, rash, shortness of breath and chest tightness one hour after receiving vaccine. Took zantac, zyrtec, benadryl, albuterol and prednisone at home. 24 hours later all symptoms but chest tightness have resolved. Patient is declining medical care.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Albuterol,Asthma,Asthma,,Seasonal,"['Chest discomfort', 'Dyspnoea', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 929821,RI,49.0,M,"flushing, hypertension, tachycardia, cold, clammy",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,none,none,none,,none,"['Cold sweat', 'Flushing', 'Hypertension', 'Nasopharyngitis', 'Tachycardia']",1,MODERNA,IM 929822,CA,37.0,F,Still has a dollar sized hive on her arm a week after her injection itchy,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,UNK,,,,,,"['Injection site pruritus', 'Injection site urticaria']",1,MODERNA,SYR 929823,VA,23.0,F,Blistered area approx 1 inch in length at injection site- was observed the day after receiving vaccine. States that she has taken OTC Benadryl for symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,None,None,None,,None per patient,['Injection site vesicles'],2,PFIZER\BIONTECH,IM 929824,AL,52.0,F,"Temp 102.3 ,Severe headache, whole body muscle aches, felt like I was on fire from the inside out.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Losartan Protonix Celexa Vitamin D Vitamin B Vitamin C Ginger Tumeric NAC Baby Asa Probiotic,No,Controlled HTN,,Penicillin,"['Body temperature increased', 'Burning sensation', 'Headache', 'Myalgia']",1,PFIZER\BIONTECH,IM 929825,PR,45.0,F,Swelling and redness around the eyes and lives. Treatment benadril 50 mg po stat.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,Diovan 320/25 mg,none,Asma,,"Aspirin, Yodo, marisco","['Eye swelling', 'Ocular hyperaemia']",1,PFIZER\BIONTECH,IM 929826,NE,42.0,F,"ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND A GOLF BALL SIZED RED AREA AROUND INJECTION SITE THAT IS WARM TO THE TOUCH. CURRENTLY AWAITING INSTRUCTIONS FROM PRIMARY PROVIDER.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,,,,,,"['Fatigue', 'Injection site erythema', 'Injection site warmth', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 929827,IL,30.0,F,Low grade fever 99.1. Chills. Body aches. Headache. Fatigue. Lasted from at least 6:30am to 10:00pm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PUB,"Lo lo estrin, Allegra 24 hour allergy medicine, spironlactone 150mg,",None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,SYR 929828,MO,49.0,F,"Pruritus, pain, erythema, and induration that has spread to entire back of upper arm (above the elbow)",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/05/2021,7.0,PVT,,,,,,"['Erythema', 'Induration', 'Pain in extremity', 'Pruritus']",1,MODERNA,IM 929829,CO,29.0,F,"Side effects included diffuse myalgias preventing sleep, fatigue, chills, mild headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,Generic yaz.,None.,None.,,None.,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 929830,OH,66.0,F,On 1/8/21 this individual called in to report that on 1/7/21 she started with a localized injection site reaction that is approximately the size of a 50-cent piece that is reddened and warm to the touch. She was unable to report this to her v-safe account,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/07/2021,8.0,PUB,,,,,,"['Injection site erythema', 'Injection site reaction', 'Injection site warmth', 'Local reaction']",UNK,MODERNA,IM 929831,CA,29.0,F,"dizziness, body pain in arm chest and back, painful to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,ultram,vaginal bleeding,none,,none,"['Back pain', 'Chest pain', 'Dizziness', 'Pain in extremity', 'Tenderness']",2,PFIZER\BIONTECH,IM 929832,IN,34.0,F,"I received my vaccine on 12/31/2020, that evening I had redness, swelling, and heat at the injection site. It went away by the 3rd day. On 1/8/2020 the redness, swelling, and heat at the injection site returned. The area is tender to the touch. I've taken Ibuprofen and will use an ice pack for the localized reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/08/2021,8.0,OTH,,,,,Cefzil Lactose Intolerance,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 929833,MT,34.0,U,"Skin redness about an inch around area of injection, very mild itchiness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/08/2021,9.0,PUB,"Prenatal vitamin, dha, stool softener, collagen, vitamin c",None,None,,Keflex,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,SYR 929834,CO,30.0,F,"Pt received first dose of Pfizer COVID vaccine on 12/22/20 on L deltoid. On 12/25/20 Pt began developing a rash on her left elbow. Rash then spread to the bilateral arms and became more concentrated, and scantly on the bilateral lower extremities. She denies any other symptoms. No improvement with hydrocortisone cream. Pt presented to Urgent Care on 12/29/20 for workup. Per provider ""On exam there is a concentrated erythematous papular rash that blanches with pressure on the bilateral upper extremities, right greater than left. It coalesces on the right arm as seen in picture below. It does feel rough in texture. No vesicular lesions, bulla, crusting. Few erythematous papular lesions that are scant on the bilateral lower extremities. Rash spares the palm and soles of feet. Exam otherwise unremarkable."" Pt treated with 12 mg dexamethasone PO and given prednisone 20 mg BID X 5 days for outpatient prescription. Patient was discharged without further escalation of care.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/25/2020,3.0,WRK,,,,,,"['Dry skin', 'Pallor', 'Rash', 'Rash erythematous', 'Rash papular']",1,PFIZER\BIONTECH,IM 929835,,34.0,F,"The following was reported by the vaccinated individual: I received my first dose of Pfizer Covid vaccination in my right deltoid on Monday January 4, 2021. 30 minutes post injection I began experiencing numbness and tingling in my left cheek, left arm and hand, and left leg & foot. This continued on Jan 5th. On Jan. 6th the symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 929836,WV,29.0,F,"Achy, tired, dull headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,SEN,None,None,None,,"PCN, Sulfa","['Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 929837,TX,42.0,F,"nitial Encounter: Per patient, she has had allergic reaction to sulfa drugs. When she took sulfa medication, she developed hives and tongue swelling. She denies having any respiratory or anaphylactic reactions. Patient denies wanting to speak to her provider about getting the vaccine and has consented to get the vaccine today. Patient is aware that she will be monitored for 30 minutes by nurse. 16:22: Patient is currently complaining of tongue tingling and concerns for tongue swelling. Patient escorted to room 11 with resource RN available. 1624: Patient brought back to Obs room 11 for complaint of tingling to tongue. On assessment Patient was alert and oriented, Sat probe placed and BP cuff, observed patient to have redness to chest and that continued to worsen as BP cuff placed. Clear to all lobes, no increased WOB. Per patient tongue felt tingley, no swelling observed to tongue, lips or face. VS obtained at 1624: HR 124, RR: 16, Pox: %99, BP: 159/102 tp Lt arm. Pt developed redness to Lt arm from elbow down to wrist. VS obtained again, HR: 114, RR: 16, Pox: %99, BP: unable to obtain as patient was moving arm. Patient began complaining of increased itchiness in mouth and ""lip swelling"", writer and PCT both observed swelling to patient upper lip. Instructed nurse to call 911, called back to Obs rm 11to assist. Epi pen administered to Rt quadricep at 1633, VS reassessed; HR: 116, RR: 16, Pox: %99, BP: 169/107 (126) Rt arm. Redness to Lt arm, chest and neck began to resolve and swelling to upper lip began to resolve, clear to all lobes. Doctor arrived to Obs rm 11 and was updated on events. Patient remained alert throughout. Patient's daughter notified via teams and was able to call and speak with her mom. EMS arrived and care transferred. Per EMS patient was to be transferred to hospital. Patient left on EMS stretcher with personal belongings. Reporter by nurse.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,unknown,Unknown,Nondisclosed,,sulfa's,"['Erythema', 'Lip swelling', 'Oral pruritus', 'Paraesthesia oral']",1,MODERNA,IM 929839,LA,51.0,F,"Low grade fever, headache, body aches (flu like symptoms)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,none,none,none,,none,"['Headache', 'Influenza like illness', 'Pain', 'Pyrexia']",6,MODERNA,IM 929840,NJ,34.0,F,"Dizziness- following day, until present time (continual) Arm weakness - 4 days after administering Leg weakness - 4 days after Muscle twitching / restless legs -4 days after",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/27/2020,1.0,WRK,"5,000mg biotin Nature made women?s multivitamin Calcium citrate 325 mg Vitamin D 25mg",,High Cholesterol Migraine with Aura,,"Zithromax- stomach issues Aspartame, sucralose- migraine","['Blood folate normal', 'Blood iron normal', 'Blood magnesium normal', 'Dizziness', 'Full blood count normal', 'Lipids normal', 'Muscle twitching', 'Muscular weakness', 'Restless legs syndrome', 'Serum ferritin normal', 'Vitamin B12 normal', 'Vitamin D']",1,MODERNA,IM 929841,CA,35.0,F,"Injection site soreness, fever 101F, chills/rigors, severe nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,None,None,None,,Erythromycin,"['Chills', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 929842,PA,37.0,F,About 34 hours after receiving the vaccine I started with severe stomach pain followed by vomiting every 20-40 min until 8:30 am; Following the vomiting I was still incredibly nauseous and still have intermittent stomach pain. I have NEVER had a vomiting episode like that ever in my life. I called my PCP at 8am and asked for a prescription for an anti-nausea medication which I have taken 5 doses of since receiving on 01/5/2021 at 12:00 PM. I'd like to state that other then going to receive my vaccine I have not been around anyone to have gotten a stomach bug. My husband whom I live with did not start throwing up either so I don't think it was anything I could have passed to him. I don't know that this was caused by the vaccine however I did want to report it incase. I am having the 2nd dose on 2/1/2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,None,None,Restricted Lung Disease,,None,"['Abdominal pain upper', 'Nausea', 'Vomiting']",1,MODERNA,IM 929843,NJ,32.0,F,"Received 2nd dose of Covid vaccine on 1/6. On 1/7 at 0130 woke up with chills, severe headache, and body aches, but no fever. She took Advil, which helped but on 1/8 she still has headache and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,none,none,none,,none,"['Chills', 'Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 929844,WV,48.0,M,"all joints hurt, right arm swollen from elbow down to fingers, tingle sensation in lower right arm and fingers",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,PUB,"Mobic, lisinopril",none,none,,none,"['Arthralgia', 'Paraesthesia', 'Peripheral swelling']",1,PFIZER\BIONTECH,IM 929845,OK,42.0,F,"immediately after to covid vaccine, client started c/o difficulty swallowing. She was transported to their emergency care area, vitals were monitored. Approx 10mins after this episode, she told them she has had this problem for the last 2 weeks. She denies shortness of Breathe or chest pain. Client was release to a family member. Her husband said she never had any other problems, except the shot made her ""tired and achey"". She was referred to her PCP for follow up>",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,"Diabetes oral medications, can't remember the name of them.",diabetes,diabetes,,none,"['Dysphagia', 'Fatigue', 'Immediate post-injection reaction', 'Pain']",1,PFIZER\BIONTECH,IM 929846,FL,30.0,F,"Moderna COVID-19 Vaccine EUA Within one hour of injection, my right arm was tingling and face felt flushed. Those symptoms lasted 30-45 minutes and resolved with no intervention. Within 6 hours of injection, pain at the injection site observed. Within 12 hours of injection, as well as pain at the injection site, general muscle aches and joint pain observed and resolved with no intervention within 24 hours of initial injection. Pain and tenderness at the injection site still observed within 24 hours of injection but better and slowly resolving with no intervention. No redness, warmth, swelling of injection site and throughout body observed within 24 hours of initial injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Sprintec; Ibuprofen; Women's Daily Vitamin; Hair, Skin, and Nail vitamins; Nasonex; Vistaril",None,None,,"Silver, fire ant bites","['Arthralgia', 'Flushing', 'Injection site pain', 'Myalgia', 'Paraesthesia']",1,MODERNA,SYR 929847,CA,29.0,F,"Sore arm, tenderness, weakness in arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,,,,,,"['Muscular weakness', 'Pain in extremity', 'Tenderness']",1,MODERNA,SYR 929848,AR,41.0,F,"Diarrhea, nausea, and fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,none,none,none,,none,"['Diarrhoea', 'Fatigue', 'Nausea']",2,PFIZER\BIONTECH,IM 929849,PR,32.0,F,"Headache began at 1:00 PM same day after receiving vaccine, with arm pain for 2 days. Unexpected menstruation on 1/6/2021, with intense menstrual pain more than experienced before.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Dysmenorrhoea', 'Headache', 'Pain in extremity']",1,MODERNA,IM 929851,IN,68.0,F,"Immediately sore right arm lasting approximately 1 day. Then after initial dose on the second day after first injection, I began with chills, headache, fatigue, body aches. By the second day after initial dose, I began with mucus cough and same symptoms with chills, headache, fatigue and body aches. I took Tylenol, cold and cough medication. It is the third day after injection, symptoms same, but slightly better, still extreme fatigue and body aches and chills and I took an Proventyl inhaler as needed. Note, I do not take Proventyl inhaler on a regular basis, I just felt the need as I was beginning to have a lot of bronchial mucus. The inhaler seems to help. I am waiting it out and did not contact my family physicians. I am hoping I will feel better soon. Still taking OTC medications and Tylenol, fluids and rest.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,OTH,"Vitamin D, Colistipol and Pepcid 20 mg.","None....healthy for page ----no underlying issues except for borderline cholesterol, GERD, and Osteopenia",.borderline elevated cholesterol which I am taking Colestipol. GERD - Pepcid OTC Vitamin D - Osteopenia,,"Codeine, Compazine, Phenergan, Morphine, Flouroquinolones","['Chills', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Productive cough']",1,PFIZER\BIONTECH,SC 929852,WV,38.0,F,"12-23-2020 Pain and swelling at the injection site and lymph nodes under her arm, HA, N&V, fever, bruising at the injection",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,PVT,,,,,,"['Headache', 'Injection site bruising', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 929853,SD,34.0,M,Red rash at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/05/2021,7.0,PVT,,,,,,"['Injection site rash', 'Rash erythematous']",1,MODERNA,IM 929854,,26.0,F,"Rigors, fever, headache and arm soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,none,none,none,,none,"['Chills', 'Headache', 'Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH, 929855,CT,46.0,F,"left arm pain and swollen lymph nodes in left arm pit generalized muscle aches, slight headache, slight fatigue started 12 hours after my second Pfizer dose, better with ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"venlafaxine, latoprasole, vit D, claritin,",non,anxiety GERD endometriosis,,none,"['Fatigue', 'Headache', 'Lymphadenopathy', 'Myalgia', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 929856,ME,31.0,F,"Paresthesias right upper extremity--numbness, pins and needles, cold-pack sensation travelling from hip to knee. Tingling and weakness in bilateral upper extremities.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,WRK,"acetaminophen, aviane",,post COVID-19 infection 10/2020,,"crab, shrimp, scallops (eye + tongue swelling)","['Feeling cold', 'Injection site hypoaesthesia', 'Injection site paraesthesia', 'Muscular weakness', 'Paraesthesia']",1,MODERNA,IM 929857,PR,38.0,F,The patient present some flushing after vaccine administration and he doctor give Benadryl 50 mg IM one dose.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,['Flushing'],1,PFIZER\BIONTECH,IM 929858,CO,34.0,F,"Eight days post vaccine woke up with warmth, erythema, pain, induration to the area suspicious for soft tissue infection/cellulitis. Symptoms starting to improve after doxy x48 hours, I plan to take a full ten day course.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,OTH,Motrin,None,Migraine,,None,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 929859,IL,50.0,F,"seizure activity, sent to the hospital for low blood pressure",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,SEN,carbidopa/levodopa daily multi vitamin lamotrigine rasagiline vitamin D zonisamide,none,cerebral palsy seizure disorder,,"NKDA, NKA","['Hypotension', 'Seizure like phenomena']",1,MODERNA,IM 929860,AZ,29.0,F,"Complaining of left deltoid site pain hot and red. Pt complaining of fatigue and feelings of SOB overnight when laying flat on back. Complaints of heat sweats overnight. States this morning she is not having SOB, but having pain from left elbow up to shoulder injection site. States no visible rash other than injection site redness. Encouraged to call 911 if she has SOB that is unrelieved. Also stated that she is having Headaches that are not relieved by tylenol. Gave pt a list of normal reactions including, headaches, body aches, fever, fatigue. Encouraged her to alternate tylenol and Ibuprofen for body aches and headaches. Encouraged pt to call 911 with SOB that is not relieved. Contacted physician.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,,,,,,"['Dyspnoea', 'Fatigue', 'Feeling hot', 'Headache', 'Hyperhidrosis', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Pain', 'Pyrexia']",1,MODERNA,IM 929861,CT,25.0,F,"A few hours after the shot my left arm was VERY sore. It felt as if someone had hit me with a metal rod. I started to feel chills and back pain around 7 pm. Throughout the night my arm was throbbing and I had a hard time sleeping. I woke up around 12 am to use the restroom. My body felt VERY heavy and weak. I woke up today (1 day after the shot) and felt better. However, my arm still has severe pain and I experiencing fatigue. I also feel like the back pain goes in and out.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,Birth Control,,"I got diagnosed with fifth disease when I was 22, which caused chronic urticaria.",,,"['Asthenia', 'Back pain', 'Chills', 'Discomfort', 'Fatigue', 'Pain', 'Pain in extremity', 'Sleep disorder']",1,MODERNA,SYR 929862,MT,38.0,F,"Shaking chills approximately 12 hours after 2nd dose received. Severe rhinitis during the day on 1/7/21 which resolved the next day, 1/8/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,UNK,,None,None,,Sulfa allergy,"['Chills', 'Rhinitis']",2,PFIZER\BIONTECH, 929863,TX,61.0,F,"Nausea, fever, body aches, headaches, same symptoms as when I had Covid19. Arm very sore still.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PUB,Olmesartan for blood pressure,none,blood pressure,,Ace inhibitors,"['Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 929864,TX,38.0,F,Reported numbness on the left side of face after receiving first dose of vaccination and left deltoid. Was transferred to emergency department at local hospital.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,SEN,Unknown,Unknown,Unknown,,No reported allergy history,['Hypoaesthesia'],1,PFIZER\BIONTECH,IM 929865,OR,48.0,F,"2 days after receiving vaccine, I am experiencing severe ""ringing"" in my ears. (Tinnitus)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,WRK,"Multi vitamins, Vitamin D, B-complex vitamin, glucosamine",None,None,,Macrobid Bactrim,['Tinnitus'],1,MODERNA,IM 929866,PR,45.0,F,"Fever, Headache, Shaking Chills, Discomfort in the body. I am taking Panadol every four hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,SEN,None,High triglycerides,None,,None,"['Chills', 'Discomfort', 'Headache', 'Pyrexia', 'Tremor']",2,PFIZER\BIONTECH,IM 929867,OH,29.0,F,"After vaccine was administered throat and tongue started tingling and worsened as 10 mins later. I was administer Allegra. After Allegra, I started getting redness and blotchy in my neck, jawline and abdomen. After 1 hour the Allegra lessened the redness and throat and tongue tingling. Next day 1/8/21 I had a fever, chills, nausea, headache and body aches. All reported to PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Nikki(birth control) Prozac Zyrtec Vitamin D Multi women?s vitamin,N/a,POTS PCOS,,Percocet Latex Nystatin,"['Chills', 'Erythema', 'Headache', 'Nausea', 'Pain', 'Paraesthesia oral', 'Pharyngeal paraesthesia', 'Pyrexia', 'Rash macular']",1,MODERNA,IM 929868,CA,30.0,F,"After 15 min from receiving vaccine I started feeling tightness in my throat, chest and my mouth , the nurse were walking around so I told the nurse I could not breath and the nurse told the doctor and the doctor looked into my mouth and saw my mouth and throat were swelling. I was taken into a clinic room and given a epi shot and another one less then ten mins. both given to left thigh . Along with oxygen. Ambulance came and given Benadryl and started and IV. they took me to the hospital. once I was at the hospital I was given a shot of prednisone and had a fast HR, was released 3 hours later (1/7/21) Was given RX by the ER doctor. Still have a sore throat, my tonsils are really really bright red , my tongue is still a little swollen with red dots and a tingle feeling.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,none,no,no,,tordol,"['Chest X-ray', 'Chest discomfort', 'Electrocardiogram', 'Mouth swelling', 'Oropharyngeal pain', 'Paraesthesia oral', 'Pharyngeal swelling', 'Swollen tongue', 'Throat tightness']",1,MODERNA,IM 929869,TX,34.0,F,"Fatigue, and chills no treatment initiated. will continue to monitor symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Chills', 'Fatigue']",2,PFIZER\BIONTECH,IM 929870,IN,54.0,F,Pain in left arm radiating up neck into jaw and temple. Within 10 minutes a very bad headache. Within 1 hour body aches.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Spironolactone Citalopram,None,Acne,,No,"['Headache', 'Pain', 'Pain in extremity']",1,MODERNA,IM 929871,TX,53.0,F,"10 minutes after vaccination patient stated that her left arm (injection arm) felt heavy and that her left jaw and left ear felt hot, numb, congested and swollen. Patient was having no problems breathing, no wheezing, no problem swallowing so we did not administer epinephrine. We called 911 in case symptoms escalated at 12:55pm. EMS was present in 5 minutes. EMS monitored patient but left store at 1:23 because patient did not want to go to emergency room and her symptoms were not worsening. Patient stated that her husband was home, very close by, and that he was a nurse practitioner and that he was going to monitor her at home. Patient purchased Benadryl liquid and Claritin tablets.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PHM,,,,,Shellfish and Seafood,"['Ear discomfort', 'Ear swelling', 'Feeling hot', 'Hypoaesthesia', 'Limb discomfort', 'Swelling face']",1,MODERNA,IM 929872,AZ,64.0,F,Sever hot flash raising heart rate high blood pressure 192/112 the paramedics stay with me for an 1hr in a half I had high blood pressure it started 20min after the vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,SCH,Regular Multi vitamins,No,No,,Sulfa,"['Heart rate increased', 'Hot flush', 'Hypertension']",UNK,PFIZER\BIONTECH,IM 929873,TX,32.0,F,"Approximately 13-14 hours after 2nd vaccine dose, developed generalized fatigue, myalgias, chills, and low grade fever (100.6F oral temp). Symptoms largely resolved within 24 hours; however, had persistent eye soreness (pain with lateral movement) through 72 hours post-vaccination for which additional evaluation was sought.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Albuterol inhaler PRN (pre-exercise),no known,mild intermittent asthma,,Cat allergy only,"['Chills', 'Eye pain', 'Fatigue', 'Myalgia', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 929874,WV,38.0,F,"12-23-2020 Pain and swelling at the injection site and lymph nodes under her arm, HA, N&V, fever, bruising at the injection",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,PVT,,,,,,"['Headache', 'Injection site bruising', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 929875,CA,24.0,M,"Patient walked out fine after receiving the vaccine. Was able to walk up to the registration desk and carried a conversation with the staffs. He sits down in the waiting area to be monitored. We heard his phone dropped, looked up and saw him tilting over on the right side was about to fall off the chair. Staff grabbed him and held him back onto the seat, proceeded to picked up his right arm and held him in place. He looked unconscious while staff held him. He came back to his senses approximately 10 seconds later. After he regained consciousness, staff took his blood pressure which was 111/44, SpO2 was 100%, and heart rate 58. Patient looked pale but not critical. Conversed with our staff and stated that this has happened before when he receives other vaccinations. Patient's father is a physician and reported that the patient is scared of needles and did not need any medications from anaphylaxis kit or crash cart. We gave him water and he left after sitting for a while.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Loss of consciousness', 'Pallor', 'Posture abnormal']",1,PFIZER\BIONTECH,IM 929876,MI,55.0,F,"pt reported ""throat feels itchy and is tightening"", epinephrine im given, vitals monitored Pulse ox 99-100%, Pt reported within 1 min of epinephrine administration, that she no longer felt that her throat was ""itchy and tightening"" response team arrived within 5 min, and pt was transported to ER",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,unknown,unknown,unknown,,"pcn, hornet, adhesive","['Throat irritation', 'Throat tightness']",1,PFIZER\BIONTECH,IM 929877,LA,67.0,F,"Patient appeared nervous upon receiving vaccine. Patient reported trouble swallowing ( has a history of radiation therapy on throat). When asked if breathing was restricted, patient was able to take long breaths with minimal additional effort. Shortly after, patient appeared to be close to passing out (not completely awake and alert), eyes dilated. The pharmacist who administered the vaccine then administered one dose of the epinephrine (Epi-pen LOT:0FM353/eEXP:NOC 21) while the staff member kept the patient stable in her chair. The facility was instructed to call 911. At 11:49 AM (7 minutes later), symptoms began to improve and the patient became more alert. EMS arrived around 12:00PM to take patient to hospital--patient refused and was back walking around the facility 5 minutes later. No further issues were reported with this patient (pharmacist administering the vaccine left the facility around 1:15PM)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,SEN,see patient for more info,"emphysema, TIA's (transient ischemic attacks), anxiety, COPD, smoker, see patient for more","emphysema, COPD, hypertension, see patient for more",,none listed,"['Dizziness', 'Dysphagia', 'Nervousness']",1,MODERNA,IM 929878,CA,31.0,F,"within about 5 minutes after the injection I got warm and flushed feeling all over my body, my body started feeling tingly all over even my tongue, but it never swole. My HR went up to the 160s, my BP was elevated to like 166/80. I was given 25mg benedryl, which calmed the flushed feeling and I was monitored for about 30 minutes and finally my BP and went back down to around 130/70 and my body normalized out besides the tingling which lasted the remainder of the day. I had a little nausea. I went back to work and finished out the day. I took more benedryl when I got home to help with the tingling feeling which finally deminished after about 24 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"Vit C, Prenatal Vitamin",no,no,"MMR-fever, chills-2015 or 2016 unsure","Contact allergy to nickle, Seasonal allergies","['Blood pressure increased', 'Feeling hot', 'Flushing', 'Heart rate increased', 'Nausea', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 929879,NE,41.0,F,COVID-19Vaccine EUA Sore arm for about 2 days Red area where shot was given size of 50 cent piece Chills that lasted about 10 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,daily vitamin metotorporol water pill,,,,penicillin,"['Chills', 'Injection site erythema', 'Pain in extremity']",UNK,MODERNA, 929880,FL,32.0,F,Patient experienced tingling in hands and anxiety after first dose of COVID 19 Vaccine (Pfizer). Patient was monitored for 30 minutes and did not require medical treatment.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,Adderall XR 25 mg po QAM,None known,ADHD,,Shellfish allergy (swelling),"['Anxiety', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 929881,CA,63.0,F,"Pt was complaining of being light headed, dizzy, and nauseous 15 minutes after vaccine administration. Pt was did not receive treatment and refused care. Pt was assessed by paramedics and signed out AMA.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,SEN,None,,None,,None,"['Dizziness', 'Nausea']",1,MODERNA,IM 929882,OR,46.0,F,"Appears to be localized Type 4 hypersensitivity reaction with large induration, redness, warmth that developed 7 days after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,None,none,none,,miconazole,"['Erythema', 'Hypersensitivity', 'Induration', 'Local reaction', 'Skin warm']",1,MODERNA,IM 929883,IN,68.0,F,"Initial right arm soreness. Second day after initial dose. chills, headache, fatigue, stuffy nose, cough, with lots of mucus and cough. Taking Tylenol, OTC cold medication and inhaler as needed. Waiting it out with rest, fluids, medication.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Vitamin D Colestipol 1 gram Pepcid 20 mg.,None,gastric reflux Osteopenia,,"Codeine, Compazine, Phenergan, Morphine, All Flouroquinolones","['Chills', 'Cough', 'Fatigue', 'Headache', 'Nasal congestion', 'Pain in extremity', 'Secretion discharge']",1,PFIZER\BIONTECH,SC 929884,IN,48.0,F,warmth to arms and ? chest tightness,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,None,,,,"Excedrin migraine, Motrin, ASA, codeine","['Chest discomfort', 'Skin warm']",1,MODERNA,IM 929885,IA,44.0,M,Patient received vaccination on Day 9 from symptom onset of COVID-19 disease after discharge from hospital. No adverse reactions at this time.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['COVID-19', 'No adverse event', 'SARS-CoV-2 antibody test positive']",1,MODERNA,IM 929886,IA,66.0,F,Mild to moderate localized soreness upper arm near site of injection without redness or notable swelling lasting 24-36 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,none,none,none,,none,['Injection site pain'],1,MODERNA,IM 929887,TX,54.0,F,"Area around injection site was initially red, raised and sore but went away after 2 days. Today is day 8 post-vaccine, and the area around the injection site is red, raised, and very itchy. Lymph node under arm feel swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,PVT,"Metformin 1000mg Zyrtec 10 mg biotin AZO urinary health probiotic Vitamin D (once a week prescription) Airborne Immunity Support (vitamin C, Zinc, Echinancea)",none,Pre-diabetic Prone to Kidney stones,,seasonal allergies lactose intolerance,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Lymphadenopathy']",UNK,MODERNA,SYR 929888,NY,53.0,F,"Following 1st Covid shot on 12/31; about 2 hours afterward experienced extreme fatigue, nausea, and dull headache. All mild and expected as possible side effects. No concerns. Symptoms continued and by 1/5; all symptoms had move to severe level and are still occurring today 1/8. Temperature spikes to 102.8; chills, severe headache especially in eye sockets, body aches, and heaviness in chest. Could not work on 1/7 and only for a bit on 1/8 (working from home). Became concerned and was flu and covid tested on 1/7; both negative. I was retested for Covid on 1/8 and still negative. I am not sure if maybe I am sick with something else and this is coincidence or if I am just experiencing issues from the vaccine that are a little different from others?",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,None,None,None,,None,"['Body temperature increased', 'Chest discomfort', 'Eye pain', 'Fatigue', 'Headache', 'Impaired work ability', 'Influenza virus test negative', 'Nausea', 'Pain', 'SARS-CoV-2 test negative']",UNK,MODERNA, 929889,NM,48.0,M,"Swelling/redness/pain at injection site, 1 week after vaccine injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PHM,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",UNK,MODERNA,IM 929890,PR,54.0,F,At night I felt fatigue and palpitations and could not sleep. Next morning the palpitations and fatigue went away but I start with a rash and very itchy and noticed my face swelling up. I took some prednisone I had home and Benadryl and went to the ER. They monitored me and medicated me and told me to keep with the Benadryl. On the 24th I started with the rash and on the 26th no more rash. My second dose is scheduled on the 13th and I will see my PCP on the 12th to decide if I should have the second dose. I am not allergic to anything and thought I would die on 12/24. I was swelling up in less than a minute after I woke up it was awful. I also have a consultation with an allergist on Tuesday before the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,High Blood pressure medication abupro,No,No,,None,"['Fatigue', 'Palpitations', 'Pruritus', 'Rash', 'Sleep disorder', 'Swelling', 'Swelling face']",1,PFIZER\BIONTECH,SYR 929891,NY,47.0,F,"Left cheek/chin, numbness, , left arm paresthesia,, left side weakness of mouth, left tongue numbness, left sided neck numbness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,None,,,,none,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Facial paresis', 'Full blood count normal', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia']",UNK,MODERNA,IM 929892,MO,32.0,F,"12/22/2020 Reported to ER rash on right arm and trunk/neck, heaviness on chest, tingling in face. Instructed to take 50mb Benadryl every 6 hours as needed. DX: Adverse Reaction to Coronavirus vaccine 12/30/2020 Reported to ER possible infection to right arm. Pain and redness around injection site. X-ray completed-No abscess noted. DX: Cellulitis around injection site. Instructed to use hot compresses. Bactrim Ds and Doxycycline prescribed. 12/31/2020 Reported to ER with complaint of right arm pain, general malaise, body aches, fever. No evidence of cellulitis at this time, no worsening erythema, no evidence of hives. DX: Protracted reaction to the vaccination. Prescription for Prednisone given and advised to take Pepcid twice a day for 5 days. Continue Benadryl as needed. Instructed to follow up with primary care doctor.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,PVT,,,,,"Amoxicillin, Cephalexin, Ciprofloxacin, Gentamicin, Levofloxacin, Nitrofurantoin, Penicillins","['Adverse reaction', 'Chest discomfort', 'Injection site cellulitis', 'Malaise', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Pyrexia', 'Rash', 'X-ray limb normal']",1,MODERNA,IM 929893,TX,40.0,F,"Received vaccine at 1730, then just before midnight my heart began to pound hard and very fast, and it made me feel short of breath or as though I had to cough. After about a minute I thought it might be SVT so I did a valsalva maneuver and it stopped. I was resting in bed, no alcohol or caffeine, and this has never happened to me before. Since then, I have felt at least one heart palpitation per day, sometimes many more. The last few days I have felt extremely fatigued and have had an odd sensation in my chest. On 1/7 I developed a dry cough, and was swabbed for Covid because I felt so bad. It was negative. This made me wonder if the odd sensation in my chest was related to my heart and not my lungs. I am due for my second vaccine today, and am unsure if I should get it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,"Zyrtec, Prilosec",None,"Seasonal allergies, occasional reflux",,Sulfa Humira Bactrim,"['Chest discomfort', 'Cough', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Palpitations', 'SARS-CoV-2 test negative', 'Supraventricular tachycardia']",1,PFIZER\BIONTECH,IM 929894,OH,32.0,F,"Severe chills lasting 4 hours, fever of 101.1, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,None,None,None,,None,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 929895,CA,41.0,F,"Arm swelling and tenderness from wednesday until friday After, could feel hardness and it was itchy from saturday through thursday Still feels hard but no longer itchy Day after felt throat and ear pain but went away within a day.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,UNK,,,,,,"['Ear pain', 'Induration', 'Oropharyngeal pain', 'Peripheral swelling', 'Pruritus', 'Tenderness']",1,MODERNA,SYR 929896,MO,34.0,F,"Moderna COVID?19 Vaccine Experiencing an Ulcerative colitis flare, i.e. abdominal cramping, rectal burning, increased stool (10 or more a day)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,"1.2 GM Lialda BID, Vit D 5,000 iu once daily, citalopram 50mg once daily",,Ulcerative colitis and anxiety,,contrast dye,"['Abdominal pain', 'Anorectal discomfort', 'Colitis ulcerative', 'Frequent bowel movements']",UNK,MODERNA,IM 929897,IL,39.0,M,"Moderna COVID-19 Vaccine EUA Injection site reaction. Redness, swelling, itching, warmth. diameter 3 inches. Began over a week after injection. Symptoms prior to this were only soreness immediately following injection that had resolved within 36 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,Aspirin,none,Born with one Kidney.,,"Penicillin, Nickel","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 929898,OH,67.0,M,"Chills, body aches, headache, nausea, backache been going on for 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,NKDA,"['Back pain', 'Chills', 'Headache', 'Nausea', 'Pain']",UNK,MODERNA, 929899,OR,48.0,F,"2 days after receiving vaccine, I am experiencing severe ""ringing"" in my ears. (Tinnitus)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,WRK,"Multi vitamin, Vitamin D, B-complex vitamin, glucosamine",None,None,,Macrobid Bactrim,['Tinnitus'],1,MODERNA,IM 929900,MO,46.0,F,"arm swollen, painful, and difficult to move. headache and stiff neck. body aches. chills. extreme fatigue. I got the shot Monday morning. the arm pain started that evening and by Tuesday morning I had all of the above. it was very difficult to make it through the work day. several times I had to put my head down on my desk and rest. after work I went home and went to bed and slept until Wednesday morning. the arm was still a little tender to the touch Wednesday but that slowly faded away.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,"fluoxetine, omeprazole, modafinil, Xarelto, bupropion",none,fibromyalgia,,none,"['Chills', 'Fatigue', 'Headache', 'Mobility decreased', 'Musculoskeletal stiffness', 'Pain', 'Pain in extremity', 'Pain of skin', 'Peripheral swelling']",1,MODERNA,IM 929901,WI,50.0,F,"I?m very dizzy, headache, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/08/2021,3.0,SEN,"Labetalol, prenatal multivitamin, aller-Zyr","Ear pain , pain on the back of my head",High blood pressure,,Sulfas,"['Dizziness', 'Headache', 'Nausea']",1,MODERNA,SYR 929902,NE,42.0,F,"ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND GOLF BALL SIZED RED AREA AROUND INJECTION SITE THAT IS WARM TO THE TOUCH. AT THIS TIME AWAITING FURTHER DIRECTION FROM PRIMARY PROVIDER.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,,,,,,"['Fatigue', 'Injection site erythema', 'Injection site warmth', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 929903,KS,78.0,F,"Patient received Moderna vaccine on 12/29/2020. Minimal discomfort the day after. Patient called today to report on 1/6/2021 she developed red, raised area at injection site. Warm to the touch and itchy. Today symptoms have improved. Patient reports she applied ice to injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,"Atorvastatin, Carvedilol, Lorsartan, Asa, ferrous fumarate, naproxen, tizanidine.",None,"Hypertension, Esophageal reflux, Coronary athersclerosis, pharyngoesophageal dysphagia, osteopenia, chronic kidney disease (stage 3)",,Codeine,"['Discomfort', 'Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Injection site warmth']",1,MODERNA,IM 929904,TX,61.0,F,"Employee received vaccine at 8:10AM. Slight throat tightness was reported at 8:24AM. Patient given Benadryl suspension 25 mg at 8:26am. Patient then reported throat felt, ""a little better"". Vital signs BP=189/88; P=90; Oxygen saturation 97% room air; Temp 97.3. At 8:30 patient reports throat feels ""worst"". Pt. noted to have bumps on tongue - 1 size of chick pea and smaller bumps on back of tongue. Oxygen sats 91%. Epi pen administered at 8:37am and EMS called. 8:45 SAFD on site.BP = 207/81; P=110;oxygen sat = 100% room air. 8:41 Bumps on tongue decreased in size. Oxygen sats 99% room air. 8:52 Paramedics arrive and patient taken to hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,WRK,Losartan; Vitamin D,None,Hypertension,,No Known allergies,"['Oropharyngeal discomfort', 'Throat tightness', 'Tongue eruption']",1,PFIZER\BIONTECH,IM 929905,MT,51.0,F,"headache, body aches, & joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Arthralgia', 'Headache', 'Pain']",1,PFIZER\BIONTECH,IM 929906,MI,30.0,F,"Headache, pain and warmth of injection site, and strange dreams",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Adderall XR 20 mg, Celexa 20 mg, Vitamin D2 400 IU, OTC Zyrtec, Lutein 40 mg w/ Zeaxanthin",,,,"Amoxicillin, Aspirin","['Abnormal dreams', 'Headache', 'Injection site pain', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 929907,IL,23.0,F,"Day 8 developed lymph node soreness & swelling in arm of injection, and swelling & redness around injection site. Still slightly swollen today. Patient did have a visit with primary care physician due to worry about lymph node swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/07/2021,7.0,PVT,,,,,,"['Anxiety', 'Injection site erythema', 'Injection site swelling', 'Lymph node pain', 'Lymphadenopathy', 'Peripheral swelling']",1,MODERNA,IM 929908,WV,66.0,F,"12-23-2020 Fever, chills, increased heart rate night of her injection",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,PVT,,,,,,"['Chills', 'Heart rate increased', 'Pyrexia']",1,MODERNA,IM 929909,CA,31.0,F,"Pt had reported feeling dizzy, then mouth swelling, and nausea. Pt was treated by ED staff after presenting back to vaccine clinic site. Pt received Epinephrine, Solu-medrol, and Benadryl, and is no longer experiencing any sxs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,None,Influenza Vaccine,Flu Vaccine,"['Dizziness', 'Mouth swelling', 'Nausea']",1,PFIZER\BIONTECH,IM 929910,KY,43.0,F,"The patient had a previous reaction to a flu vaccine. She was treated for Bell's Palsy related to the flu vaccine 3 years ago. The patient with the moderna vaccine started feeling left arm weakness and the arm felt heavy. She was unable to lift arm. She had a lump in her throat but minimal difficulty breathing and swallowing. She then reported right arm weakness and being unable to move either arm. She was having episodic type reactions. Every few minutes she would lose color and appear to be having difficulty breathing and swallowing but would come back to normal within a minute or two. After the 4th episode in which she stated she was going to pass out and could not move her legs, we had EMS called to come monitor the patient. EMS took vitals and monitored for and additional 20-30 minutes. The patient refused to leave with EMS and I continued to monitor for a short time longer for the duration of about 1.5 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PHM,None,None,None,Influenza,Codeine; Morphine; Pseudoephedrine,"['Dysphagia', 'Dyspnoea', 'Heart rate increased', 'Limb discomfort', 'Loss of consciousness', 'Mobility decreased', 'Movement disorder', 'Muscular weakness', 'Pallor', 'Sensation of foreign body']",1,MODERNA,IM 929911,TX,53.0,F,"Symptoms - ? EE woke up this am with body aches, chills, headache (endorses hx of migraine), and fever (Tmax 101.8). Last day of work and shift - ? supposed to work tonight but called off due to feeling ill Home remedies? - Tylenol at 0740 and sleep Any improvement? ? mild improvement Recommendation? EE educated to continue to monitor symptoms and call vaccine support with further concerns or questions. EE educated of changes in RedCap Survey and educated will need to be fever free for 24 hours before returning to work. EE reports she called off of work tonight as she is not feeling well. EE educated to continue to manage her symptoms and to follow the guidelines outlined in the TCH Illness in the Workplace Policy. EE denied COVID-19 exposure without proper PPE and denied travel. EE verbalized back understanding and denied further questions at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Chills', 'Headache', 'Illness', 'Impaired work ability', 'Malaise', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 929912,CA,50.0,F,"decreased sensation to light touch of right anterior distal thigh with intermittent shocklike pain starting on 12/24/20 which has gradually improved with only rare episodes of numbness as of today 1/8/20. No weakness, back pain or injury.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/24/2020,6.0,PVT,"turmeric, vitamin d, ginseng, ashwagandha, rhodiola, Motrin, Flonase, Claritin",none,"endometriosis, migraines, asthma",,sulfa penicillin,"['Hypoaesthesia', 'Paraesthesia', 'Sensory disturbance']",UNK,PFIZER\BIONTECH,IM 929913,CA,31.0,F,within 5 minutes after the vaccination I got hot an flushed all over. I was nauseated and my BP went to 166/80 HR 160s. My body began to feel tingly all over even my tongue but it never swelled. I was given 25mg of benedryl and monitored for 30 minutes and finally my body began to normalize and my BP went down to 130/70. I went back to work but when I got home I took more benedryl because my body still had the same tingly feeling. After about 24 hours all symptoms had subsided.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"Vit C, Prenatal Vitamin",no,no,MMR- hives and fever 2015 or 2016,"Contact allergy to nickle, Seasonal allergies","['Blood pressure increased', 'Feeling hot', 'Flushing', 'Nausea', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 929914,WA,49.0,F,"12 hours after injection I acutely developed headache, chills, sweating, muscle aches, nausea, hand and face swelling, swelling and tenderness around injection site, general flu-like symptoms making it difficult to sleep. I was able to go to work the next morning despite symptoms. Symptoms, other than mild soreness in arm where injected, resolved 36 hours after onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Chills', 'Headache', 'Hyperhidrosis', 'Influenza like illness', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Nausea', 'Peripheral swelling', 'Sleep disorder', 'Swelling face']",2,PFIZER\BIONTECH,IM 929915,HI,46.0,M,"Approx 8 hours after injection I suddenly became slightly dizzy and had moderate nausea. I also became very tired and fell asleep for about 1.5 hrs even though I was well rested. For the remainder of the night of 5 Jan and all day on 6 Jan I was fatigued and had moderate injection site pain. On 7 Jan, I felt much better (no fatigue or injection site pain) but had a very hard time mentally focusing. All symptoms resolved by the night of 7 Jan and as of 8 Jan feel normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,MIL,none,none,none,,none,"['Disturbance in attention', 'Dizziness', 'Fatigue', 'Injection site pain', 'Nausea']",1,PFIZER\BIONTECH,IM 929916,,38.0,F,"Within a few minutes of the vaccine, patient felt face flushing, metallic taste in mouth. Benadryl 25 mg po given without improvement in symptoms. Benadryl 25 mg po repeated and patient taken to ED. Was discharged home. Returned to ED about an hour later for chest pressure which resolved prior to arrival. Given Prednisone 40 mg po in ED and discharged home. Recommended no second dose of covid vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Chest discomfort', 'Dysgeusia', 'Flushing']",1,MODERNA,IM 929917,SC,41.0,F,"I woke up from sleep with severe chest pain at approx. 0400. It was sharp and radiated up to the left side of my neck. The pain was worse with breathing whether I was sitting up or lying down. My heart rate was 150 initially, but came down to 110's after a few minutes of waking up. My heart rate did not decrease with rest and the chest pain was not going away, so I drove to the emergency room to be checked. Before I left the house I used my albuterol inhaler once to see if it would make the chest pain and tightness any better. I received an EKG, mylanta mixed with lidocaine, IV pepcid and IV torodol to help relive the pain. The pain eased some (was a 8/10 when I awoke to a 2/10 after treatment). My blood was drawn, a chest x-ray was taken and the provider informed me all of my lab results, chest x-ray, and physical examination was normal. My EKG showed tachycardia and my heartrate did not drop below 100 beats per minute throughout the whole ER visit. My BP at the highest was 151/94. I have never had a problem with a fast heartrate or high blood pressure in the past. I was discharged with a diagnosis of pleurisy caused by a cough I have been having. I spent the rest of the day with chest pain and left arm pain from the site of the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,albuterol inhaler as needed; systane eye drops three times a day; advair inhaler twice a day; singulair 10mg daily,none,asthma sinusitis,,no known medications allergies,"['Chest X-ray normal', 'Chest discomfort', 'Chest pain', 'Cough', 'Electrocardiogram abnormal', 'Full blood count normal', 'Injection site pain', 'Metabolic function test', 'Neck pain', 'Pain', 'Pleurisy', 'Tachycardia']",1,MODERNA,IM 929918,TX,27.0,F,"Arm was abnormally sore to the point where it was all the way down my shoulder into my collar bone. About 24 hours after the 2nd dose, I noticed the area around my left collar bone was swollen . The area is painful to touch and contains a lump about the size of a dime. Pain is experienced when I attempt to cross my left arm over my body. Lump and pain still remains 51 hours after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,None,Unexplained diarrhea (9 days),,,None,"['Arthralgia', 'Pain', 'Pain in extremity', 'Skin mass', 'Skin swelling']",2,PFIZER\BIONTECH,IM 929919,IN,32.0,M,"Body aches, arm soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Sertraline,No,Depression Asthma,,NKA,"['Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 929920,ME,50.0,F,"7 Days after vaccine started with left axilla and arm tenderness, 8th day had itching and swelling at injection site, 9th day redness, swelling at injection site, area very warm to touch, malaise, muscle aches, headache. I will start antibiotics to rule out cellulitis vs vaccine reaction",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/06/2021,6.0,PVT,"Straterra, osteo bi flex",None,None,,Bactrim,"['Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Malaise', 'Myalgia']",1,MODERNA,IM 929921,WI,44.0,F,Small red area next to the right arm injection site with a golf size lump in the upper pole of the right breast leading into the right armpit area which started on 01/05/2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PVT,,,,,,"['Axillary mass', 'Breast mass', 'Injection site erythema']",1,MODERNA,IM 929922,MT,33.0,M,"fever, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Chills', 'Pyrexia']",2,PFIZER\BIONTECH,IM 929923,KY,28.0,F,"15 minutes post injection had numbness and tingling in left arm, complained of feeling cold, tingling started in her back too. Called for rapid response and patient was transported to ED>",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Feeling cold', 'Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 929924,MI,47.0,F,After 15 mins I felt like I couldn't breath. On the way home hour later hard to breath. I went to ER gave me Steroids and Pepcid. Since then I have taken Benadryl. On 12/30 at 10am I was exp reaction again went back to the ER. They provided me with breathing treatment and was sent home on Prednisone. I contacted my PCP to inform her that I have to continue taking Benadryl to help with sob and my voice changes. It seems like my lungs are affected due to taking the vaccine. I'm currently off and not able to receive comp due to the vaccine being voluntary.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/26/2020,0.0,PVT,,,"High blood pressure, Asthma, Hypothyroid",,"Seafood (Iodine),Bystolic","['Chest X-ray', 'Dysphonia', 'Dyspnoea', 'Electrocardiogram', 'Impaired work ability']",UNK,PFIZER\BIONTECH, 929925,WI,51.0,F,"Fever >101, rigor, chills, 15 hours post administration Cough from 6-18 hours post administration Fatigue from 6 - 20 hours post administration Muscle aches from 15 - 36 hours post administration Joint pain from 24 - 36 hours post administration",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"Lisinopril, hydrochlorothiazide",none,none,,none,"['Arthralgia', 'Chills', 'Cough', 'Fatigue', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 929926,PR,38.0,F,Patient present some flushing after vaccine administration,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,['Flushing'],1,PFIZER\BIONTECH,IM 929927,ME,39.0,F,"Within a minute or two of receiving the vaccine patient felt flush and was having trouble breathing. Adult epipen 0.3mg was administered in patient's right thigh. Also 50mg of diphenhydramine was administed in patient's left deltoid. Ten minutes later the patient was again having breathing problems. Second injection of adult epipen 0.3mg was administered in patient's right thigh. Patient was also given Lorazepam 2mg. Patient was taken to the Emergency room via ambulance. At the emergency room patient was given Prednisone and an additional 1mg Lorazepam. After observation, patient was sent home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,"Omeprazole 20mg 1 at bedtime; Synthroid (Brand) 25mcg 1 daily; Hydroxyzine Pamoate 50mg 1 twice daily; Buspirone 10mg 1 twice daily,",none,hypothyroidism,,"Flax seed, generic levothyroxine","['Dyspnoea', 'Flushing']",1,MODERNA,IM 929929,IL,51.0,F,"1 week after injection. Injection site became itchy, red and had a raised lump at site. Area was about the size of a golf ball. There is still a small bump at site 2 weeks later",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/31/2020,7.0,PVT,"Lopid 600mg 2x day, Multivitamin 1x day, fiber con 1x day, hydrochlorothiazide 12.5mg x1 day, Olmesartan-hydrochlorothiazide 20-12.5mg 1x day, tylenol ES as needed, Motrin 800 mg as needed, sudafed PE as needed,",sinus congestion,hypertension and high triglycerides,,prilosec fenofibrate,"['Injection site erythema', 'Injection site mass', 'Injection site pruritus', 'Injection site reaction']",UNK,MODERNA,IM 929930,NE,54.0,F,"ON 1/1/21, DEVELOPED SORE THROAT LASTING 2 DAYS. LOW GRADE FEVER (99.3 ON 12/31 AND 1/1. MUSCLES ACHES 1/1/21-1/3/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/01/2021,2.0,SEN,,,,,,"['Myalgia', 'Oropharyngeal pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 929931,TN,46.0,F,"she received vaccine at 8:30 am. At approximately 11:00 am she developed sudden onset hives, scratchy throat, swelling sensation of the throat, hoarse voice, difficulty breathing. Presented to the ED. Received IM Epi, IV Benadryl and Solumedrol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,after flu vaccination,,"['Dysphonia', 'Dyspnoea', 'Pharyngeal swelling', 'Throat irritation', 'Urticaria']",2,PFIZER\BIONTECH,IM 929933,OK,70.0,F,"Shortness of breath ,chest and stomach pain, fatigue very weak,headache, aches,vomiting, diarrhea. Vomiting and diarrhea started 2 days after vaccine. All others started 12 hours after vaccine except injection site 2 hours after injection. Still weak.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,PUB,None,None,None,,"Cipro, sulfur","['Abdominal pain upper', 'Asthenia', 'Chest pain', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Headache', 'Pain', 'Vomiting']",1,MODERNA,SYR 929934,TX,44.0,F,"At 3pm, I started to have a small allergic reaction. Symptoms started with sweaty palms, my tongue felt strange, my body felt weird particularly from my knees to my toes and I was easily winded moving around. Symptoms slowly progressed until I went to the dr and was prescribed prednisone and benedryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Orencia, methotrexate, myrbetriq, clonzap, Zyrtec, folic acid",None,"Rheumatoid arthritis, interstitial cystitis, seasonal allergies",,Penicillin,"['Dyspnoea exertional', 'Feeling abnormal', 'Hyperhidrosis', 'Paraesthesia oral']",1,MODERNA,SYR 929935,MD,52.0,F,"Low grade temp, chills, body aches, nausea and diarrhea, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,SEN,lisinopril 20mg and tylenol 325mg,none,hypertension,,nkda,"['Chills', 'Diarrhoea', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 929936,,41.0,F,"Patient / side effect / called out to work due to fever 99. to 100.4; chills, nausea, fever, body aches (5/10, from 8/10) / called out from work due to 100.8 fever / feeling better at the time of call / severe arm pain (6/10, from 8/10)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,OTH,Nortryptaline 30mg 1x day,No,Fibromyalgia,,Nsaids (can't take Motrin type meds); gluten allergy,"['Chills', 'Impaired work ability', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 929937,FL,25.0,F,"Patient states that she got her coronavirus vaccine and about 10 min later she felt very weak diffusely, felt her ears ringing and passed out. Patient was caught and lowered to a chair, thus did not hit her head. Patient states she has passed out before but this felt different. Patient felt her heart racing prior to passing out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,UNKNOWN,NONE,NONE,,NKDA,"['Asthenia', 'Culture urine', 'Human chorionic gonadotropin', 'Loss of consciousness', 'Metabolic function test', 'Palpitations', 'Tinnitus', 'Urine analysis']",1,MODERNA,IM 929938,FL,36.0,F,Started with just a very sore arm. Swelling of axillary lymph nodes. Woke up and blood pressure dropped (fainting). Then felt extremely hot and feverish (no actual fever).mild constant dizziness accompanied with nausea.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,None,None,None,,None,"['Blood pressure decreased', 'Dizziness', 'Feeling hot', 'Lymphadenopathy', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Syncope']",1,MODERNA,IM 929939,IN,21.0,F,Weakness and body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,UNK,Celexa 40mg 1x daily Adderall 20mg 2x daily Birth control 1x daily,None,None,,None,"['Asthenia', 'Pain']",1,MODERNA,SYR 929940,NE,27.0,F,She reports waiting the allotted time of 15 minutes after receiving the Covid injection. She reports after the 15 mins. that she returned to her work area where co-workers commented that she had a red blotchy hive looking rash around her neck and upper trunk area. She denied any itching or SOB and reports that the blotches were noted for approx. 3 hours after shot. She was instructed prior to 2nd Covid shot to contact PCP with understanding voiced.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,Birth Control Medication,Denies and illness at time of vaccine or one month prior.,Denies any chronic of long-standing health conditions.,,"NKA to medications, foods or other products","['Rash', 'Rash erythematous', 'Rash macular']",1,MODERNA,IM 929941,NY,55.0,F,"Wheezing, cough,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Ventolin, Singulair, Loratadine, Halcion,,prn, Bendadryl,prn, Albuterol neb,prn, Protopic, Lamisil, Omeprazole, dicyclomine",None,"Asthma, IBS, Hypothyroid, Dermatitis, Insomnia",,"Morphine, Codeine, Clindamycin","['Cough', 'Wheezing']",UNK,MODERNA,IM 929942,IL,70.0,F,fatigue body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,SEN,acetaminophen aripiprazole aspirin daily multi vitamin famotidine fluticasone lecithin levothyroxin loratadine calcium plus vitamin D senna plus trolamine cream vitamin c,none,moderate intellectual disability hypothyroidism osteopenia seasonal allergies depression,,NKDA,"['Fatigue', 'Pain']",1,MODERNA,IM 929943,MD,61.0,F,"Received flu shot in Left arm and did not feel anything so very surprised to next get TDAP in Right arm and immediately experience ""fireworks"" pain at injection site radiating down arm. Looked at needle as it was withdrawn and appeared longer than expected (I used to be a nurse). Pharmacy tech said I could go but was nervous to leave store so walked around and felt my right arm grow heavy and difficult to raise. Eventually drove home using left arm to steer. Took tylenol with little result. Following day called pharmacy who said DTAP is known to be uncomfortable and they ""never use needles longer than 1 inch."" By Wed 9/23 arm was not improving so called insurance advice nurse who said go to urgent care but declined to avoid unnecessary covid exposure. She said to wear arm sling and use Voltaren gel because I cannot tolerate NSAIDS. Following morning I had a virtual appointment with my primary care physician who said to minimize use of sling to avoid frozen shoulder, keep using Voltaren and ask physical therapist currently treating me for rehab post back surgery 6/2020 to add shoulder exercises, and let her know if still not better in 4 weeks at which time she would refer me to Physical Medicine specialist for nerve testing. I found I had to wear sling at work (part time librarian) but was able to get by at home without it. By 4 weeks the pain and limited range of motion was improving, by then I could drive and dress myself, but it took a further 2-3 weeks to resolve fully. Primary care physician at checked with immunizations clinic supervisor who asked if the pharmacy tech had been standing (and if I were sitting) for the injection. Yes to both. Immunization clinic chief said this (bad) practice can sometimes direct the needle into the nerve or joint capsule, which may have happened in my case. If you happen to follow this up with the pharmacy please note their paperwork has the injection sites reversed. I chose to have the flu shot in my left arm and the TDAP in my right arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,09/18/2020,09/18/2020,0.0,PHM,"Vitamin D, Magnesium, Flonase, Premarin cream",,,,"Flagyl, Celebrex, Dermabond wound adhesive","['Immediate post-injection reaction', 'Injection site pain', 'Joint range of motion decreased', 'Limb discomfort', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Pain']",UNK,SANOFI PASTEUR,IM 929944,WI,49.0,F,"Called back to closed POD site because patient had become pale, clammy and irregular pulse 9:00; BP 128/82 P- 88 bounding; able to talk and explain she felt poorly, was sipping on water. Sat with client for 30 mins, color clearly improved, BP 156/88 P 84 (BP reported as more normal) Blood sugar check at beginning 151 and again about 9:25 as 151. Was now feeling very tired and wanted to go home. Had patient call her provider for guidance and a ride to home. Provider requested that she take the rest of the week off. Patient went home to rest. Thursday still very tired and headache, today better but still has a headache",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,OTH,"Diabetic, medication list uncertain",,Diabetic,,KNA,"['Cold sweat', 'Fatigue', 'Headache', 'Heart rate irregular', 'Malaise', 'Pallor']",1,MODERNA,SYR 929946,MT,59.0,F,"sore throat and hives still from Covid vaccine bodyaches, sore throat, chills just doesn't feel well, hives",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,PVT,,,,,,"['Chills', 'Malaise', 'Oropharyngeal pain', 'Pain', 'Urticaria']",1,PFIZER\BIONTECH,IM 929947,NC,62.0,F,"Chills, headache, muscle pain, tiredness, and nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,MIL,ATENOLOL/CHLORTHALIDONE 50/25 TABS,,Hypertension,,PERCOCET,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,SYR 929948,IN,37.0,F,"On day 8 after getting my injection I started to experience an adverse reaction in the area of the injection site on my left arm. The injection area was indurated, warm, red, itchy and swelling. It swelled to the size of about 1 inch wide by 2 inches long. I had no prior issues with my injection aside from some arm soreness the day after the injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,none,none,Thalassemia- a form of anemia,,Penicillin,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 929949,MA,41.0,F,"Hives,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Claritan, Benadryl, Zolair",Autoimmune disorder NOS,,report of prior flu vaccine reaction,Non specific food allergies,['Urticaria'],2,PFIZER\BIONTECH,IM 929950,IN,26.0,F,"1/6/21: 8pm (1hour after shot): sore arm, relieved with heated blanket, slept through night with no issue 1/7/21: 7am (12 hours after shot): woke up with headache and dehydration, arm where injection occurred was sore and stiff, hit to move 11am: sudden and sever fatigue, beginning of swollen lymph node (left, side of injection), felt better after laying down for around 20 minutes and drinking water& 2excedrin tablets, sore arm continuing, felt feverish though no fever, nausea 6:30pm: sudden and intense fatigue, struggling to think straight, sore arm, exhaustion, headache (, nausea, unable to lift items with left arm without considerable pain 7:30pm: arrive home and lie down By 8pm: intense chills, headache, left lymph-node swollen so it was visible to the naked eye, hurt to swallow, racing pulse despite lying down, inability to complete ADLs/ get up to take medication, frustration to the point of crying, joint pain; 8:30pm took temperature registered at 97.4 (normal), was able to take 2 excedrin pills, shortly after body temperature was regulated, racing pulse continued 11pm: asleep 1/8/21 8am: groggy to wake, arm still aching but able to move, swollen lymph node to touch but no longer glaringly obvious, throat ache (not as much as night before), abdominal pain, hot shower and excedrin and water, slow to start but able to complete ADLs and resume work 12pm: first meal of day (soup and soaked bread), hurts to swallow at times, excedrin 3:30pm (present time) thoughts are clear, throat still hurts w/o drinking/eating, arm hurts but able to lift and carry normal amount without making noises of pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,None,None,Carrier of Fragile-X; Fibromyalgia,,Tramadol and Shellfish,"['Abdominal pain', 'Arthralgia', 'Chills', 'Crying', 'Dehydration', 'Fatigue', 'Frustration tolerance decreased', 'Grip strength decreased', 'Headache', 'Heart rate increased', 'Loss of personal independence in daily activities', 'Lymphadenopathy', 'Mental impairment', 'Musculoskeletal stiffness', 'Nausea', 'Odynophagia', 'Oropharyngeal pain', 'Pain in extremity', 'Pyrexia', 'Somnolence']",1,MODERNA,SYR 929952,TX,31.0,F,I had a fever of average 101.5 throughout the night and into the following morning. I also had one episode of vomiting at 11:40 pm on the same day I received the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,Sulfa drugs Topical corticosteroids and frangrances,"['Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,SYR 929953,TX,58.0,F,Red itchy rash at the injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,SCH,Estrace,None,None,,Aleve,"['Injection site rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 929954,AS,31.0,F,"Pt recieved injection at 1000, began feeling dizzy around 1045, pts sxs continued to worsen with nausea, and mouth swelling noted. Pt returned to the vaccine clinic and was escorted to the ED. In the ED she was evaluated by the provider, and given epinephrine, solu-medrol, and benadryl, and is now recovered from her reaction and being observed in the ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,None,None,None,,Influenza Vaccine,"['Dizziness', 'Mouth swelling', 'Nausea']",1,PFIZER\BIONTECH,IM 929955,NH,55.0,F,"Rapid palpations, Peripheral numbness, Nasal and lip numbness, Throat "" Fullness"", noted posturing. Timeline of Events 1425 Vaccine Administered, Left Deltoid 1429 Symptoms Onset 1430 20mL Benadryl Administered; BP (132/84), HR 88, check lung sounds: WNL 1433 BP second check (BP 134/84) 1438 Pt noted lips, and toes felt tingly 1439 second HR check (HR 80) 1445 third BP check (132/82); pt claims past hx of stroke (x2) and SVT 1446 EMS was called 1449 Pt reports feeling of tightness in tongue and lips; pt reports similar symptoms to red wine and Novocain 1455 EMS arrived 1458 Pt was loaded into gurney and ambulance 1500 Pt depart in ambulance to the hospital",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,OTH,"Synthroid, ASA","PMHx: , Cryptogenic stroke x 2 ( Remote w/o deficit 2010), Right carotid dissection2016, (Spontaneous), SVT, DVT, Hashimoto Thyroiditis",,,"Novocain, Red wine","['Hypoaesthesia', 'Hypoaesthesia oral', 'Oropharyngeal discomfort', 'Palpitations', 'Paraesthesia oral', 'Posturing']",1,MODERNA,IM 929957,NE,77.0,F,"Injection site on left arm of resident turned red, warm, and firm. Reaction began two days after injection. Chief nurse directed resident to contact their Primary Care Provider.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/07/2021,2.0,SEN,Not available - independent living,,,,Not available - independent living,"['Injection site erythema', 'Injection site induration', 'Injection site warmth']",UNK,PFIZER\BIONTECH, 929958,WA,46.0,F,"No adverse effects initially (only soreness for first 3 days). Exactly one week after injection, soreness, redness, swelling, heat, around injection site. Spread to cover almost all of upper arm down to elbow, and wrapped almost fully around arm. Very alarming. No other symptoms. Took ibuprofen and tried to ice it. 3 days later it is getting better. Took Allegra today. Not as swollen but still there.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,Wellbutrin,None,None,,Mangoes (slight),"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 929959,MO,32.0,F,"12/22/2020 Presented to ER with rash on right arm, trunk/neck, heaviness on chest and tingling in face. Dx: Adverse reaction to coronavirus vaccine Instructed to take 50mg Benadryl every 6 hours as needed 12/30/2020 Presented to ER for possible infection to right arm. Reports pain and redness around injection site. Dx:Cellulitis around the injection site. No definable abscess on x-ray. Prescription for Bactrim Ds and Doxycycline given. 12/31/2020 Presented to ER with complaint of right arm pain, general malaise, body aches, fever. Reports site erythema, right arm pain radiates down to right hand and into right side of neck. Dx: Protracted reaction to the vaccination. Prescription for Prednisone and Pepcid given. Advised to take Benadryl as needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,PVT,,,,,"Amoxicillin, Cephalexin, Ciprofloxacin, Gentamicin, Levofloxacin, Nitrofurantoin, Penicillins","['Chest discomfort', 'Injection site cellulitis', 'Injection site erythema', 'Injection site pain', 'Malaise', 'Neck pain', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Pyrexia', 'Rash', 'X-ray normal']",1,MODERNA,IM 929960,VA,59.0,F,"swelling, redness, itching and warmth to touch which has slowly increased in size. As of 1/8 is about 3 inches X 3 inches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,PVT,,,,,,"['Erythema', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,IM 929961,TX,66.0,F,"Swelling, redness painful injection area. Entire upper arm hot and swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,PVT,"hctz, Lisinopril, Losartan, Prilosec Vitamin D",none,hypertension GE Refux osteoporosis,,nkda or food,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 929962,CA,24.0,F,Rash on face the night of injection that resolved the following day. Severe right hip and knee pain 11 days after the injection that is still occurring till this day. Hip would pop and was painful to walk and lay down.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,01/01/2021,11.0,WRK,None,None,"Asthma, allergic rhinitis",,"Gentamicin , apples, grass, weeds, trees","['Arthralgia', 'Gait disturbance', 'Rash']",1,PFIZER\BIONTECH,SYR 929963,,34.0,F,"increased heart rate, SOB, Tingling, Hot flushed, Red chest, mouth dry",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,"['Dry mouth', 'Dyspnoea', 'Erythema', 'Heart rate increased', 'Hot flush', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 929964,FL,93.0,F,RESIDENT COMPLAINED OF CHEST PRESSURE AND DIFFICULTY BREATHING ABOUT 1 HOUR AFTER VACCINE ADMINISTRATION. SENT TO HOSPITAL FOR EVALUATION. RETURNED HOME 2 HOURS LATER. SPOKE WITH RESIDENT AT 830am ON 1/7/21 AND SHE REPORTED SHE FELT FINE AND FELT SHE MAY HAVE HAD A PANIC ATTACK. SPOKE WITH RESIENT AT 830AM ON 1/8/21 AND SHE REPORTED SHE FEELS FINE.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,SEN,UNKNOWN,,,,UNKNO,"['Chest discomfort', 'Dyspnoea']",1,PFIZER\BIONTECH,SYR 929965,TN,72.0,F,"PATIENT STATES SHE HAD REDNESS TO HER SITE OF VACCINE ON HER LEFT ARM ON 12/26/20. THE REDNESS SHORTLY AFTER WENT AWAY AFTER TAKING BENADRYL AND RETURNED ON 1/1/21. PATIENT TOOK BENADRYL ON 1/1/21 AND ON 1/2/21, REDNESS INCREASED AND PATIENT WENT TO ER. WHERE THEY GAVE HER PREDNISONE. WENT AWAY AND CAME BACK ON 1/5/21. WAS PERSCRIBED STEROID CREAM AND KEPHLEX ABX. ON 1/7/21 PATIENT NOW HAS RASH ON HER LOWER ABD. SHE WAS BEING SEE BY HER NURSE PRACTIONER ON 1/7/21. WHEN I SPOKE WITH HER ON 1/8/21, HER RASH SEEMS TO BE LESSENING.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/26/2020,3.0,PUB,none,none,none,,sulfa,"['Injection site erythema', 'Rash']",1,MODERNA,IM 929966,MT,43.0,M,"fever, muscle aches, joint pain staying home",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Arthralgia', 'Impaired work ability', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 929967,IL,41.0,F,"Achy body, headache, ear ringing, chills and a temperature.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Body temperature increased', 'Chills', 'Headache', 'Pain', 'Tinnitus']",2,PFIZER\BIONTECH,SYR 929968,IL,29.0,F,"Woke up with fever day after receiving second vaccine, Tmax 102.2 with associated headache, fatigue .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Tylenol, motrin",none,none,,none,"['Fatigue', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 929969,OH,23.0,F,"From 8am till about 10am I felt shaky after the injection. I dint feel like chills, had no temperature. I could not stop shaking, felt like a deep muscle shake. I felt shaky and jittery from 8am till 11am. I had a cup of tea where I was able to fall asleep. I had a telemedicine call and I spoke to a NP and she recommended to go to an ER but I did not go. I just felt very anxious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,WRK,"Vitamin C, Multi-vitamins",None reported,None reported,,None reported,"['Anxiety', 'Feeling jittery', 'Tremor']",1,MODERNA,IM 929971,TX,70.0,M,"Significant flare of PsO in surface area and thickness. I have never been on biologic and only use nonsteroidal topical creams (3% salicylic acid). The flare stared approximately Day 7 after 1st dose, and has continued to worsen exponentially. 2nd dose received today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/24/2020,6.0,OTH,"amlodipine, clopidogrel, Dexilant, ezetimibe, Flonase, hydroxyzine, Metformin, montelukast, rosuvastatin, Synthroid, aspirin (enteric coated), cetirizine, famotidine, fexofenadine, loratadine, folic acid, multivitamin, Vit B complex, VIt C,",none,"CAD, HTN, AODM, OSA, Asthma, PsO",,some statins,['Back pain'],1,PFIZER\BIONTECH,IM 929972,VA,41.0,F,"PT had aa mild reaction with hives and itchy skin on her upper chest and face. No airway or breathing involvement. Pt given 25mg Benadryl, symptoms began to resolve after 30-40 min.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,"Enbrel, Sulfasalazine and albuterol",mild back pain,rheumatoid arthritis,,Fruit and nuts (minor reactions) Shell fish (anaphylaxes),"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 929974,CO,28.0,F,Fever and headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/08/2021,7.0,UNK,,,,,,"['Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 929975,TX,72.0,F,"After Moderna vaccine I had chills started night of vaccine on 1/6/2021 and noon on 1/7/2021 extreme fatigue, nausea, chills and heart rate of 35 and oxygen in 90. On 1/8/2021 I am much better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,"Amlodipine Besylate 5 mg, Clopidogrel (Plavix) 75mg, Valsartan 80mg (Diovan), Ezetimibe 10mg (Zetia), Rosuvastatin Calcium 40mg, Myrbetriq 25mg, Women 50+ Multivitamin, Vitamin D-3 2000IU, Sunbiotic 365",none,"? High blood pressure disorder ? Acid reflux disease ? High cholesterol, LDL goal below 70 ? Impaired glucose tolerance ? Residual cognitive deficit as late effect of cerebrovascular accident (TIA Stroke 9/2014) ? Small vessel disease, cerebrovascular",,caffeine,"['Chills', 'Fatigue', 'Nausea']",1,MODERNA,SYR 929976,NJ,46.0,F,"Headache, Fatigue- on day 2 Bels Palsy- Day 4",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/07/2021,3.0,PVT,Levoxyl 127 mcg Duloxetine 40mg Nexium,none,Hypothyroidism from thyroidectomy on medication,,Penicillin Levaquin,"['Blood test', 'Facial paralysis', 'Fatigue', 'Headache', 'Magnetic resonance imaging']",UNK,PFIZER\BIONTECH,IM 929977,IN,33.0,F,"Developed rash, itching on arm and on chest, tingly feet and dry cough, dry mouth",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Synthroid, Mirena IUD, occasionally take ibuprofen and Pepcid AC",hypothyroid,Hashimoto's thyroiditis; hypothyroid; thyroid cancer history,,Sulfa,"['Cough', 'Dry mouth', 'Paraesthesia', 'Pruritus', 'Rash']",UNK,PFIZER\BIONTECH,IM 929978,ME,39.0,F,"Within a minute after receiving the vaccine, patient felt flush, face was very red, and was having serious trouble breathing. Adult epipen 0.3mg was administered in patient's right thigh. Diphenhydramine 50mg was also administered in patient's left deltoid. 10 minutes after administration, patient again was having severe trouble breathing. A second dose of adult epipen 0.3mg was administered in patient's right thigh. Patient was also given Lorazepam 2mg. Patient was then taken to the Emergency Room by ambulance. At the emergency room patient was given predisone and an additional Lorazepam 1mg. Patient was observed and then sent home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,"Vitamin D, Omeprazole 20mg, Synthroid (Brand) 25mcg, Hydroxyzine Pamoate 50mg twice daily, Buspirone 10mg twice daily",none,hypothyroidism,,"flax seed, levothyroxine (generic only)","['Dyspnoea', 'Erythema', 'Flushing']",1,MODERNA,IM 929979,HI,46.0,M,"Pfizer-BioNTech COVID-19 Vaccine Approx 8 hours after receiving the vaccine, I suddenly became slightly dizzy and moderately nauseous. I also became very tired even though I was well rested. The nausea and dizziness lasted approx 2-3 hours. At that time I developed moderate injection site pain. I was very fatigued for the remainder of the night and through the next day (6 Jan). I was no longer fatigued as of 7 Jan but starting that morning I had a very difficult time focusing mentally. That condition lasted until late on the evening of 7 Jan. As of 8 Jan, all symptoms have resolved and I feel fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,MIL,none,none,none,,none,"['Disturbance in attention', 'Dizziness', 'Fatigue', 'Injection site pain', 'Nausea']",1,PFIZER\BIONTECH,IM 929980,MI,58.0,F,"Start with the normal sore arm continues on day five, normal headache two days. On the second day, very stomach pain so bad could not sleep now for three days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Baby aspirin, Fish oil, Bystolic 2.5mg, Vitamin D-3 and Women's One a Day",None,Birt Hogg Dube Syndrome,,None,"['Abdominal pain upper', 'Headache', 'Pain in extremity', 'Sleep disorder']",1,PFIZER\BIONTECH,SYR 929981,CA,46.0,F,C/o nausea. no other symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,['Nausea'],1,MODERNA,IM 929983,AZ,41.0,F,"1st dose Moderna injection given on Dec. 29 2020. Left arm at injection site became itchy (and left side of body random itchiness.) Spot itchy for 1.5 days and bump appeared (looked like ant bite, but did not hurt.) Resolved after 2 days with no medial intervention or drugs. Today is 01/08/2021 and bump appears to have resolved, no itchiness or redness. No headache no body ache. Possible joint achiness for the 1.5 days. All resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,PVT,none,no illnesses,Remission Graves Disease. At time of reaction no issues with thyroid,,no known food allergies,"['Injection site pruritus', 'Injection site swelling', 'Pruritus']",1,MODERNA,IM 929984,FL,67.0,F,"Following administration of the first dose of the COVID19 vaccine (Pfizer) patient reported right sided lip tingling (no swelling or drooping), and a ""weird"" feeling in chest (no additional details provided). Patient appeared anxious, but declined feeling anxiety. Patient declined medical treatment/follow-up and her symptoms resolved. Note: Patient received second dose of COVID19 vaccine (same lot# EH9899) on 1/8/2021 with close monitoring and no adverse reactions occurred.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,None known,None known,None known,,"Aspirin (unknown reaction), Sufur (unknown reaction)","['Chest discomfort', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 929985,NE,56.0,F,"ON 1/4/21, DEVELOPED FEVER, ARM SWELLING, CHILLS, AND BODY ACHES AROUND 8PM AND LASTED ABOUT 24 HOURS.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,,,,,,"['Chills', 'Pain', 'Peripheral swelling', 'Pyrexia']",1,PFIZER\BIONTECH,IM 929986,KS,57.0,F,"Pt was given her first dose of the Moderna Covid-19 vaccine on 1/4/2021 at the health center. She then called us at the county health dept several times requesting the vaccine because she is a healthcare professional. She came to the health dept on 1/7/2021 and received another dose of the Moderna Covid-19 vaccine, without disclosing to us that she had received a dose 3 days earlier. . Making it a total of 2 doses only 3 days apart. Pt was contacted after it was realize and she stated that she did this because she did not think she actually received her first dose because she did not feel it. She has not reported any adverse effects .",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,,,,,,"['Inappropriate schedule of product administration', 'No adverse event']",2,MODERNA,IM 929988,OH,54.0,M,"Client complains of itching, burning, redness, swelling, warm to the touch at injection site. State he has used ibuprofen, benedryl, and ice pack to relieve symptoms. No improvement since started yesterday, but reports he is at work today and is not able to treat symptoms regularly. He will continue current treatment of symptoms and report any improvement/worsening over the next few days. He has been advised to seek emergency care if he should have worsening symptoms and/or has any difficulty breathing. He also reports he gets annual flu vaccines and was in the military and has not had reactions to vaccines like this in the past.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PUB,,,,,Flagyl,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 929989,VA,44.0,F,Tightness in throat 30 minute after administration of the vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,none,none,none,,none,['Throat tightness'],1,PFIZER\BIONTECH,IM 929990,TX,34.0,F,"Fever for 20 hours, acetaminophen Myalgias for 48 hours, acetaminophen headache for 24 hours, acetaminophen chills for 24 hours, acetaminophen tenderness at injection site for 48 hours, acetaminophen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"Citalopram, fiber, vitamin D, vitamin C, daily vitamin",,,,,"['Chills', 'Injection site pain', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 929991,PA,44.0,F,"redness, swelling, warmth, pain, firmness 7 days after vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,PUB,na,none,none,,"keflex, codeine, shellfish","['Erythema', 'Induration', 'Pain', 'Skin warm', 'Swelling']",1,MODERNA,IM 929992,TX,37.0,F,"Approximately 1 week post-injection (1-7-21), began feeling soreness return to injection site. Upon waking the next morning (1-8-21), site red, swollen, warm to touch, and tender. First drew border around redness at approximately 0845; by 1300, redness increased in diameter and has spread the width of my arm. Tenderness and swelling have increased as well to approximately a 5-6"" diameter. Have taken benadryl PO 25 mg. No other treatment/action at this point.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,,,"Migraines, metabolic syndrome, anxiety, depression",,"methergine, inderal","['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 929994,OH,37.0,M,"Body Aches, dizziness, and fever for over 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,Albuterol PRN,None,None,,NKDA,"['Dizziness', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 929995,NM,20.0,F,"Patient vaccinated in left arm on 12/31/20 on 1/8/21 noted spot of redness, swelling and pain. Not sure if this is a cellultis",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/08/2021,8.0,PHM,"Cephalexin, ibuprofen and benadryl",no,Pernio (Chiblains,,Penicillans,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 929996,CA,48.0,F,Bilateral arm numbness starting approximately 36 hours post administration of the vaccine. Symptoms are only in the middle of the night. No numbness when upright and moving around.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/06/2021,2.0,WRK,"MVI, vitamin d",,,,almonds,['Hypoaesthesia'],1,MODERNA,IM 929997,WI,86.0,M,"Patient received vaccine on 1/4/2021. He was in Hospice for CHF and renal failure, but was able to get up in his wheelchair and eat and take medications and talk. On 1/5/2021 am, he was noted to be very lethargic an could only mumble, could not swallow. No localizing neurologic findings. He was too lethargic to get up in chair.",Yes,01/07/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,SEN,"Amlodipine 5 mg daily, Dexamethasone 4 mg daily (for itching related to renal failure), Isosorbide dinitrate 30 mg daily, Levothyroxine 0.075 mg daily, Bisoprolol 5 mg BID, Furosemide 80 mg BID, saline nasal spray, Tylenol 1000 mg PO TID",none acute,"He was on hospice for about the last 1 month for CHF (EF 20-25%) and renal failure (creat 3-4). He was on hospice but was up and around and able to eat and take pills. The day after he had his injection, he was very lethargic and only mumbled. Was not able to take meds or eat. He was on hospice, so did not want work-up or treatment. He passed away on 1/7 am. We don't know if it was a coincidence that he died or if the vaccine caused him to deteriorate more quickly.",,"Losartan, lisinopril, metoprolol","['Death', 'Dysphagia', 'Feeding disorder', 'Lethargy', 'Mobility decreased', 'Speech disorder']",1,MODERNA,IM 929998,IN,39.0,F,"5 minutes after receiving shot I felt a strong headache come on. Tylenol did not alleviate the pain. Later in the day I began to feel flu like symptoms with fever reaching 100.3. Same symptoms Day 2. Now, day 3 I still feel flu like symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,none,on menstrual cycle at time of vaccination,none,,none,"['Headache', 'Influenza like illness', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 929999,NE,43.0,F,"ON 12/30/20, DEVELOPED ITCHING, IRRITATION OF VAGINAL AREA. WENT TO SEE HER DR. AND SAID SHE HAD A YEAST INFECTION.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,SEN,,,,,,"['Fungal infection', 'Vulvovaginal discomfort', 'Vulvovaginal pruritus']",1,PFIZER\BIONTECH,IM 930000,NJ,74.0,F,"Patient developed sudden onset of severe vertigo with nausea and vomiting. She became very week. Blood pressure was above usual level (149/88) and she had nystagmus with no other focal neurologic signs. She continues to be ""dizzy"" but no true vertigo now. She is weak and fatigued.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/07/2021,10.0,PUB,"pravastatin, clopidogrel, black yeast, ocular vitamins",none,ASHD with two stents,,none,"['Asthenia', 'Blood pressure increased', 'Dizziness', 'Fatigue', 'Nausea', 'Nystagmus', 'Vertigo', 'Vomiting']",1,MODERNA,IM 930001,NC,47.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA. Sweating, lightheaded",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,None,,,,None,"['Dizziness', 'Hyperhidrosis']",2,PFIZER\BIONTECH,IM 930002,NY,33.0,F,"9:30 AM - Recipient sent to observation area post administration- tolerated well. In observation area 5 min. later recipient began stating she feels dizzy, screaming she does not feel well, began shaking upper torso and extremities, eyes shut - placed on ground floor with elevated legs, applied 10L/min oxygen via mask, v/s taken (HR/PR/ Pupil reaction), EPIPEN 0.3mg administered @ 9:38 am, with good response as recipient seemed to calm down, no screaming, no shaking. At 9:52am EMS arrived and took over.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PUB,unknown,Unknown,Unknown,,NKA,"['Dizziness', 'Malaise', 'Screaming', 'Tremor']",1,MODERNA,IM 930003,,37.0,F,"Hx of anaphylaxis to bee stings. Rash and hives over upper chest began immediately following vaccine. Taken to ED and given IV Benadryl, Famotidine and Solu-medrol. Discharged home from ED. Recommended to not receive second dose of covid vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Immediate post-injection reaction', 'Rash', 'Urticaria']",1,MODERNA,IM 930004,OR,43.0,F,"8 days after vaccine was administered, the patient developed redness, swelling, warmth and hardness at the injection site. The redness is about the size of a fist. Person encouraged to seek treatment with their PCP or urgent care.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,PVT,unknown,unknown,unknown,,none,"['Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA,IM 930005,AZ,26.0,F,"initial; swelling of tongue, tingling and numbness in legs, syncope. later; HA",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,none,none,cholecystectomy one month prior to vaccination with chronic diarrhea since,,"cephalosporins, tramadol","['Chest X-ray', 'Computerised tomogram head', 'Headache', 'Hypoaesthesia', 'Lumbar puncture', 'Magnetic resonance imaging spinal', 'Metabolic function test', 'Paraesthesia', 'Swollen tongue', 'Syncope', 'Urine analysis']",1,MODERNA,IM 930007,NM,45.0,F,"Patient was at work and felt nauseous at around 0800 and took a Zofran. Then around 1030 she started to have lower chest (near the lower ribs) pain 9/10 pain and she was diaphoretic. We called 911 as we were concerned about an MI. She was transported via EMS to the hospital. They ran various tests and determined it wasn't cardiac or lung issues and was likely side effects from the COVID vaccine. On 1/8/21, Patient reports that she feels dizzy and is ""itching all over."" She took antihistamine and that helped the itching symptom.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,,,,,None,"['Chest X-ray', 'Chest pain', 'Computerised tomogram thorax', 'Dizziness', 'Electrocardiogram', 'Hyperhidrosis', 'Laboratory test', 'Nausea', 'Pruritus']",2,PFIZER\BIONTECH,IM 930008,NJ,46.0,F,About 3 hours after the injection I started to develop upper Left arm and shoulder pain. Later that night I couldn?t lift my arm without terrible pain. I was unable to sleep despite taking Advil 800mg and heat and ice. The next day 1/7 wasn?t any better. On 1/8 I woke up and noticed the left shoulder area was red and warm to the touch. A little over 2 inches in diameter. I went to my Dr office and they diagnosed cellulitis and prescribed Keflex 500mg 3 times a day. I just took the first dose on 1/8/2021 at 2:45pm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,"Metoprolol, Ativan, amlodipine, albuterol , flovent",None,"Asthma, hypertension, anxiety",,None,"['Injected limb mobility decreased', 'Injection site cellulitis', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Pain', 'Sleep disorder']",1,MODERNA,IM 930009,MN,61.0,F,"Severe chills /tremors 14 hours following the second injection that lasted uncontrollably for one hour, headaches, fatigue, abdominal pain that cleared 1/7 in the afternoon. The nausea was so bad I could not eat. Vomited only one time. I missed one day of work, slept the whole day, and night, too.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Rosuvastatin 10mg/day.,None,Past history of ulcerative colitis. Degenerative disk disease. Osteoarthritis.,,"Sodium metabisulfite, yellow number 5, penicillin, sulfa drugs.","['Abdominal pain', 'Chills', 'Fatigue', 'Feeding disorder', 'Headache', 'Nausea', 'Tremor']",2,PFIZER\BIONTECH,IM 930010,MN,87.0,M,"Resident displayed with confusion/shaking at 1400, condition worsens at time went. Resident unable to state where he is, knows his name. can tell you he does not feel right. Temp 97.3, p 88, O2 91%, Bp 214/116 Transferred to ED with fever, temp of 103, and shortness of breath, admitted to ICU Positive COVID-19 test at hospital. Diagnoses include acute COVID-19 pneumonia and hypoxia. PO had confusion, fatigue, weakness, hypoxia, increased BP",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,"Citrucel, acetaminophen 8 hour, systane ultra, gabapentin, pantoprazole sodium, vitamin c, vitamin d3, aspirin, atorvastatin calcium, cymbalta, norco, lantus solostar, loperamide, melatonin, toprol xl, flomax, preservision areds, vitamin b-",,"Peripheral vascular disease, chronic systolic heart failure, type 2 diabetes mellitus, essential hypertension, hyperlipidemia, chronic kidney disease stage 3 unspecified, gastro-esophageal reflux disease without esophagitis, hypothyroidism, acquired absence of left and right legs below the knee",,"Colestipol, Amitriptyline, Colestid, Niacin, Ondansetron","['Asthenia', 'Blood pressure increased', 'COVID-19 pneumonia', 'Confusional state', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Hypoxia', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Intensive care', 'Pyrexia', 'Respiratory syncytial virus test negative', 'SARS-CoV-2 test positive', 'Tremor']",1,MODERNA,IM 930011,CA,26.0,M,antiseptic taste in mouth,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,['Dysgeusia'],1,MODERNA,IM 930012,KS,27.0,F,Pt had several seizures about 15 minutes after receiving the vaccine. EMS was called/evaluated the patient. The patient planned to contact her primary care provider.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,OTH,Sertraline and Depakote,,Seizure disorder; Depression,,,"['Condition aggravated', 'Seizure']",1,MODERNA,IM 930013,FL,29.0,M,"fever, chills, body aches, decreased spO2 with ambulation, tachycardia",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,"Metformin, Trulicity",Sinus Tachycardia,DM2,,NKA,"['Chills', 'Laboratory test', 'Oxygen saturation decreased', 'Pain', 'Pyrexia', 'Tachycardia']",1,MODERNA,SYR 930014,CT,19.0,M,Tested Positive for COVID 19 No prior symptoms or known exposures Flu Like Symptoms occurred Day after Running nose 2 days after Sore Throat,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,None,None,None,,Penicillins,"['COVID-19', 'Influenza like illness', 'Oropharyngeal pain', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,MODERNA,SYR 930015,CA,46.0,M,"At injection site: Itchy pink rash, 3.5? long; swelling; and feverish to the touch. Muscle and joint pain in the immediate area.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,None,None,None,,None,"['Injection site joint pain', 'Injection site pain', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,SYR 930016,TX,59.0,F,"Fatigue, knot at inj site, Face scratching, rash all over face. Skin is peeling. It is spreading.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,PHM,"Diatelazam, flecainide, hctz, metformin, Eliquis",no,a-fib,,morphine,"['Fatigue', 'Injection site nodule', 'Pruritus', 'Rash', 'Skin exfoliation']",1,MODERNA,SYR 930017,CA,52.0,M,"Patient spoke to me this morning regarding some symptoms he had after his Pfizer COVID 19 vaccination yesterday. He said he had some pain at the injection site and mild headache in the afternoon; however, around 12 to 1 am in the morning, he was feeling heart palpitation and he felt his muscle twitching from his upper torso which went down to his thigh and no loss of consciousness. He said he checked his heart rate and it was 70 and he did not have any problems breathing. He said his heart palpitation felt better after taking some deep breaths. He said he no longer had heart palpitations or muscle twitching any more. He denied any other symptoms. Generally, he appeared well, no facial drooping, awake, alert, oriented, speech clear, and normal gait. (Today)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PUB,Unknown,Unknown,Unknown,,Unknown,"['Headache', 'Injection site pain', 'Muscle twitching', 'Palpitations']",1,PFIZER\BIONTECH,IM 930018,PA,34.0,F,"For the first 10 hours I had a sore arm. 10-12 hours I began having weakness, fevers, chills, bodyaches, low back pain, intermittent neck pain. Following day I had the same symptoms in addition to left sided axillary lymphadenopathy w/ numbness of L hand 4th & 5th fingers and mild cough. Currently I am about 52 hours post vaccine with left sided axillary lymphadenopathy and intermittent numbness of left 4th and 5th fingers. Other symptoms have improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,None,None,,None,"['Asthenia', 'Back pain', 'Chills', 'Cough', 'Hypoaesthesia', 'Lymphadenopathy', 'Neck pain', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 930019,NV,31.0,M,"Low grade fever (99.5F), shaking chills, body aches, joint pain, fatigue, right arm pain, nausea. Symptoms lasted 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,"Vitamin D, melatonin, finasteride",Covid 19 (October 2020),None,,None,"['Arthralgia', 'Chills', 'Fatigue', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 930020,NE,57.0,F,"On 12/30/2020 at 1000 she developed body aches in her shoulders and lower back. Reports having stiffness in the left hip area. Denies any fevers. Noted pressure in her head and discomfort in her left ear. These were s/s similar to when she was diagnosed with Covid on Nov. 17. Reports that since Covid her taste and smell has not come back fully but wondered if it was a little worse. She ended up completing her work day after taking Tylenol x1. At end of work day she reports feeling like ""she had Covid again"". Due to s/s she was not able to work on 12/31/2020. On 01/04/2020 she presents to work with a softball size area of redness, feverish to touch, hard to touch in left deltoid area where injection was given. She reports being afebrile or any other s/s at this time. She reports that after the injection her arm was sore but did not notice until the 01/01/2021 a hardened area in the left deltoid area. She was instructed to contact her PCP due to her concerns for taking the 2nd Covid vaccination with understanding voiced.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,PVT,"Esterdiol, Multivitamin, Pravastatin, Fish Oil, Vitamin C, Zinc, Vitamin D, Calcium and Tumeric",She was diagnosed with Covid on 11/17/2020. She returned back to work on 11/30/2020 and reports extreme exhaustion through 12/07/2020. She reports noticing after having Covid episodes of having a racing heart. She did follow-up with her Cardiologist and was scheduled for a Cardiac Stress Test on 12/31/2020.,Left hip replacement 05/2019,,Sulfa and Morphine Sulfate,"['Ageusia', 'Anosmia', 'Arthralgia', 'Back pain', 'Condition aggravated', 'Ear discomfort', 'Head discomfort', 'Impaired work ability', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site warmth', 'Joint stiffness']",1,MODERNA,IM 930021,PA,34.0,F,"Sudden onset of nausea, abdominal pain and sweats. Chills and diarrhea. Most symptoms subsided after a 1-2 hours, but lower abdominal pain and feeling of having a bowel movement continued.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Abdominal pain lower', 'Chills', 'Diarrhoea', 'Hyperhidrosis', 'Nausea', 'Rectal tenesmus']",1,MODERNA,IM 930022,IL,25.0,F,"Severe headache developed about 30min after administration. Relieved by sleep. Almost exactly 24hours later, around 2pm the day after administration, developed severe occipital h/a again with radiation down into neck. Mild chills, body aches, fatigue, and tachycardia about 28 hours after administration - duration about 5 hours. Again, around 2pm the second day after administration, developed the same occipital h/a and neck pain/stiffness as well as mild tachycardia.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,"Fluoxetine 40mg, Dexmethylphenidate 15mg, oral birth control, cranberry with vitamin C, vitamin D3, apple cider vinegar pills",,,,NKA,"['Chills', 'Fatigue', 'Headache', 'Musculoskeletal stiffness', 'Neck pain', 'Pain', 'Tachycardia']",1,MODERNA,IM 930023,KS,26.0,F,ITCHING OF TONGUE AND THROAT; REDNESS OF SKIN ON NECK AND SHOULDERS,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PUB,Unknown,None,Unknown,,Penicillin,"['Erythema', 'Throat irritation', 'Tongue pruritus', 'Vital signs measurement']",1,PFIZER\BIONTECH,IM 930024,FL,61.0,F,"Shortly after receiving the vaccine (1/5/21) while waiting the 15 mins I experienced phlegm in my throat and kept trying to clear it, that resolved within 7min, I felt strange ...kind of dizzy and felt weird out of body feeling. They gave me water and crackers and said try to eat something for second shot. After 30 mins I felt OK to leave. During the rest of the day I had a headache which worsen and next day (1/6/) the same and had that weird out of body sensation off and on. I also had mild achy feeling, fatigue and both hips and shoulders mild pain. I did take this day off from work. These symptoms resolved towards the end of that night. Doing much better today (1/8/21). I aslo had mild swelling and sore at the injection site which I expected like a flu shot. I have not had any reaction to any vaccination prior years.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"zyrtec 10mg, zafirlukast 20mg,progesterone 100mg, estradiol 0.05mg patch, alprazolam 0.5mg. B12 500mcg, turmeric curcumin with bioperine2600mg, melatonin 12mg, omega 3 fish oil800mg EPA and 600mg DHA, vitamin D3 50mcg",none,asthma,,"penicillin as a child, hay fever allergies trigger asthma","['Arthralgia', 'Autoscopy', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Headache', 'Impaired work ability', 'Injection site pain', 'Injection site swelling', 'Pain', 'Productive cough', 'Throat clearing']",1,MODERNA,IM 930025,IL,59.0,F,"Upon awakening, exhausted feeling, severe weakness, total body aches, chills, temp 97.4 orally, slight nausea. Notified supervisor at work, took Tylenol 1000 mg and slept for 2.5 hours. Woke up with symptoms much reduced and went to work",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Balsalazide 750 3 caps tid, venlafaxine ER 225 daily, Bariatric vitamins, B complex daily, B12 1000 mcg daily, iron 325 tid, Vitamin D3 5000 units SSTT and 10,000 units MWF, Restasis one drop each eye daily, Entyvio 300 mg IV every 8 weeks,",None,"Clinical depression, scoliosis and kyphosis, iron deficiency anemia, ulcerative colitis",,"Erythromycin, compazine","['Asthenia', 'Chills', 'Fatigue', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 930026,OH,31.0,F,"All the covid symptoms - sore throat fever, headache; shortness of breath; no taste; fatigue; tested positive on the 23rd for Covid. 2nd dose: 1/6/2021 (received in right arm) - in am; adverse events started in the pm of the 6th: (6 Pm) - fever, chill, sweats, headache - all night into the following day for the headache; took tylenol LATE IN EVENING for fever and so no fever when I woke up 7th - took last night (7th) - still had chills and headache. (day two still) - HAS BEEN TAKING TYLENOL FOR24 HOURS BECAUSE HEADACHE IS BAD IF IT COMES ON day two - symptoms are better now; military - so was coming off covid protocol - so it complicated going back to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/22/2020,6.0,PVT,none,none,none,,Sulphur,"['Ageusia', 'COVID-19', 'Dyspnoea', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Oropharyngeal pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 930027,IA,49.0,F,"I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in armpit lymph nodes was the size of a very large egg. I couldn't comfortably put my arm down at my side. Pain radiated down arm to elbow, and up neck into ears. I had fever of 100.1, but took ibuprofen to try and alleviate pain. The symptoms lasted about 5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,WRK,hydrochlorothyazide 25mg lycinopril 20mg atorvastatin calcium 10mg,none,HTN diabetes,rabies vaccination after animal bite. 3-4 years prior. I couldn't finish series. Vaccines given at Hospital. Adverse reacti,amoxocillin - hives i had a very severe reaction to the rabies vaccination about 3-4 yrs ago,"['Ear pain', 'Injection site inflammation', 'Injection site pain', 'Lymphadenopathy', 'Mobility decreased', 'Musculoskeletal discomfort', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 930028,IL,48.0,F,"immediately felt super warm, dizzy, lightheaded, nauseous jaw pain and lower neck pain clammy hands and weakness, EMT eventually checked my vitals while in the waiting room, extremely high blood pressure and rapid heart rate transferred me to the ED via ambulance",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,lexapro multivitamin align/probiotic,none,none,,sulfa allergy neosporin allergy,"['Asthenia', 'Cold sweat', 'Dizziness', 'Feeling hot', 'Heart rate increased', 'Hypertension', 'Immediate post-injection reaction', 'Nausea', 'Neck pain', 'Pain in jaw']",1,MODERNA,IM 930029,IN,29.0,F,"Fever, chills, weakness, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,None,None,None,,None,"['Asthenia', 'Chills', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 930030,NC,57.0,M,"Pt stated with itchy hives all over face when leaving clinic on 1/7/2021. Pt has hx of allergies, so took Benedryl when arriving to home. Pt also has Epi-pen but did not need to use medication. Hives subsided to look like smaller splotchy patches on face only. Condition continues to improve but has not subsided completely as of 1/8/2020 3:52 pm. No other sx per pt.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PUB,"Seraquil, Torbistatin, Metropalol, Restiril, another anxiety med that pt is unsure of name.",None,"Depression, PTSD, hypertension",,"Sulfa, penicillin, bees, almonds","['Pruritus', 'Urticaria']",1,MODERNA,IM 930031,IN,25.0,F,Symptoms started 01/07/21 I woke up with a lump on the right side of my jaw that is closing off half of my windpipe. I also have a second lump on the back of my neck; both are tender to the touch. I had a fever of 101.3 yesterday and today it has gone between 102.6 and 103.6. I have full-body chills.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/07/2021,3.0,PVT,"Ondansetron, gabapentin, lamotragine, mirtazapine, lithium, sertraline, Pantoprazole, Propranolol, dicyclomine, Vitamin C",None,,,"Antibiotics, specifically Metrodinazole","['Chills', 'Lymphadenopathy', 'Pyrexia', 'SARS-CoV-2 test', 'Tenderness']",1,PFIZER\BIONTECH,SYR 930033,FL,46.0,M,"Following administration of COVID-19 vaccine, patient experienced ""tingling in throat and lower legs"" plus dizziness. After monitoring for 30 minutes, patient reported symptoms started to resolve. Upon follow-up, patient reported that tingling in lower legs had resolved after 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,None known,None known,None known,,None known,"['Dizziness', 'Paraesthesia', 'Pharyngeal paraesthesia']",1,PFIZER\BIONTECH,IM 930034,CA,57.0,M,"Sore arm about 6-8 hours after injection lasted for 2 days. Stiff neck, experienced shortly after vaccine lasted about 16 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Fenofibrate 145 mg,None,None,,"Walnuts, Bees","['Musculoskeletal stiffness', 'Pain in extremity']",1,MODERNA,IM 930035,KS,55.0,F,Pt had tachycardia with a heart rate in the 160's after receiving the vaccine. She also had chest pain. EMS was called and took the patient to the emergency department for evaluation.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,OTH,Unknown,,,,Unknown,"['Chest pain', 'Tachycardia']",1,MODERNA,IM 930036,TX,52.0,F,"After the vaccine, my arm went numb. I ended up having fatigue, fever, and metallic taste in my mouth. My bones hurt, and my neck hurt really bad. that lasted for three days. I developed chills and a fever, I felt really sick. I had a COVID test and was positive.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,WRK,I take medication for my anxiety disorder. Claritin D,,,,,"['Bone pain', 'COVID-19', 'Chills', 'Dysgeusia', 'Fatigue', 'Hypoaesthesia', 'Malaise', 'Neck pain', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 930037,GA,64.0,F,"No injection site issue from elbow to wrist swallen red fevered area hand was difficult to be used for 12-24 hours to subside . Very large arm left 2 - inches red a swallen 12-24 hours welts all over body three to five inches. Continuing every day . 120 dexitrun Cycles 16th day woke up intergestion roof of mounth Employee health hospialize Adverse event allergiest umulize hopital, clarifein, swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/17/2020,0.0,PVT,Rosuvastatin 10 mg Multi viatium Vitiaum D D3 Osto Byflex,No,Heart disease Heart Stint,,No,"['Dyspepsia', 'Injection site erythema', 'Injection site swelling', 'Peripheral swelling', 'Urticaria']",1,PFIZER\BIONTECH,IM 930038,CA,36.0,F,"Approx 10-15 min post-vaccine, pt began to c/o flushing and bilat feet numbness/tingling. NIBP 172/90, HR 90s. No SOB, hypoxia. Benadryl 50 IM given @ 1756. Pt discharged from vaccine clinic to ED. NIBP 157/111, HR 102 @ time of discharge.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Unknown,none,"cardiac murmur, HA, HLD, palpitations",,,"['Dyspnoea', 'Flushing', 'Hypoaesthesia', 'Hypoxia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 930039,OH,22.0,F,Extreme body aches for 24 hours. Lower back pain. Nausea. Headache. Chills. Low grade fever.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,UNK,,,,,,"['Back pain', 'Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA, 930040,AR,31.0,F,"Approximately 18 minutes post injection, patient experienced itching and whelps on opposite limb as injection site. Diphenhydramine 25 mg chewable tablets given. Itching continued into legs and skin above lips. Prednisolone 40 mg liquid given. After 10 minutes, itching and whelps improved. Patient monitored for a total of 1 hr post injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Vitamin C 1000 mg daily (Spring Valley gummy) Zinc 44 mg daily (Spring Valley gummy) Vitamin D once weekly (Replesta 50,000 iu weekly wafer)",none,none,,"No known drug allergies food: wheat environmental: trees, cockroach, grass, etc.","['Lip pruritus', 'Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,IM 930041,CO,50.0,F,7 days after shot - headache and arm became very sore with red rash and swelling and hardness.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,None,None,None,,None,"['Headache', 'Induration', 'Pain in extremity', 'Peripheral swelling', 'Rash', 'Rash erythematous']",1,MODERNA,SYR 930043,NY,42.0,F,"Fevers, chills, body aches, blotchy skin",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Tylenol,None,None,,No known allergies,"['Chills', 'Pain', 'Pyrexia', 'Rash macular']",1,MODERNA,IM 930044,SC,41.0,F,Patient presented with blotchy skin and tightness in the chest. Blood pressure was 190/110. Patient was given some oxygen and blood pressure had decreased. Patient blood pressure was still high and complaining of chest tightness.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,SEN,,,,,none,"['Chest discomfort', 'Hypertension', 'Rash macular']",1,MODERNA,IM 930045,CA,30.0,F,"25 minutes after receiving the COVID-19 (Moderna) reported having difficulty swallowing and tightness throughout the throat, able to speak clearly. No facial or lip swelling noted. Respiratory effort unlabored, denied any GI symptoms or rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,unknown,unknown,unknown,,Reported having a history of Toradol injectable that was treated with Benadryl,"['Dysphagia', 'Throat tightness']",1,MODERNA,IM 930046,NJ,40.0,F,"fatigue, headache, nausea, dizziness, body aches which started on 01/08/2021 at 0730 am, took advil at 230 pm and tylenol at 330 pm on 01/08/2021. Pt. states that she is feeling much better after tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,OTH,denies,denies,denies,,denies,"['Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 930047,WV,67.0,M,Redness and swelling to site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,SEN,"Biofreeze, Azopt , Debrox, Vitamin D 3, Flonase, Kionex, lantanoprost, Synthroid, Neurontin, Miralax, Renavite, Senna, Sodium Bicarb, Tylenol, UTI Stat, Vitamin C, Zofran and Zoloft",,"CKD, Morbid Obesity, AV Fistula, Symbolic Dysfunctions, Dementia, Idiopathic peripheral Atonomic Neuropathy, Primary Open angle glaucoma , Dysphagia, Tinea Corpus , Cystitis, Osteoarthritis, Acute and Chronic Respiratory Failure, Vitamin D Deficiency, Delusional Disorders, Schizoaffective disorder, Gastric Ulcer, Full incontinence of Feces, HTN CKD, Peripheral Vascular Disease, Recurrent Pneumonia, Bilateral hearing loss, atherosclerotic heart disease, MRSA, Seborrhea capitis, polyneuropathy, obstructive and reflux uropathy, Seasonal allergic rhinitis, Age related Nuclear Cataracts, Paraplegia, TMJ, HTN, Depression, Hypothyroidism, Anxiety, Interstitial Cystitis with hematuria, Constipation, GERD, Dry Eye Syndrome BPH, Chronic Pain Syndrome",,NKA,"['Injection site reaction', 'Injection site swelling']",2,PFIZER\BIONTECH,IM 930048,VA,49.0,F,"Pain at site, shooting down the arm and unable to lift arm. Shoulder frozen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Vitamin D, Zinc, Vitamin C, Multi Vitamin, Zyrtec",None,None,,"Penicillin, Sulfa","['Injection site pain', 'Movement disorder', 'Pain', 'Periarthritis']",2,PFIZER\BIONTECH,IM 930049,NY,31.0,M,"Symptoms : Rash on forehead and neck. Muscle weakness. Headaches. Dizziness. Treatment: Zyrtec, Tylenol, & Motrin",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,No,No,No,,Penicillin,"['Dizziness', 'Headache', 'Muscular weakness', 'Rash']",1,MODERNA,IM 930050,IL,35.0,F,"Severe nausea and vomiting, unable to tolerate PO intake for over 48 hrs and severe vomiting for 36 hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,None,Factor V leiden carrier and beta thalassemia carrier,,Latex,"['Appetite disorder', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 930051,ME,39.0,F,"Patient received her vaccination on Monday, 1/4/21. She waited her 15 minutes of observation and then left. She states on her way home she started feeling that her tongue and left side of her face was a little bit numb. It continues to be numb and on examination the left side of her face has diminished sensation. Her left eye is droopy and she has a symmetrical eyebrow raises as well as smile. Her diagnosis is consistent with possible Bell's palsy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Multiple,None,PTSD Anxiety Eosinophilic Esophagitis Sleep apnea,,Oxycodone Calcitrene Corn Progesterone Flagyl Clindamycin Topirimate,"['Facial paralysis', 'Hypoaesthesia', 'Hypoaesthesia oral']",1,PFIZER\BIONTECH,IM 930052,CA,45.0,F,"minutes after the injection the tip of my tongue and lips began tingling and my tongue went numb, the roof of my mouth began to tingle and go numb as. NO difficulty swallowing or breathing, No changes in the vitals and I was given benedryl by mouth and observed for 30 minutes with no further issues and all symptoms resolved. My right arm was tingling and weak also but to date all symptoms has resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,PVT,Claritin,no,"Hashimoto Disease, Raynaud's Syndrome",,"Vicodin, fire ants","['Hypoaesthesia oral', 'Muscular weakness', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 930053,IN,35.0,F,Had chest tightness and heart beat flutters the afternoon and evening after getting shot on 1/02/21. Chest tightness and heart beat flutters continued and I saw Nurse Practitioner on 1/04/21 and EKG showed frequent premature ventriculations (pvcs). Then referred to cardiologist for follow-up and possible treatment. Currently on a heart monitor as of 1/06/21 and waiting to get into see cardiologist for treatment for continuing pvcs and chest pressure and sometimes pain as of 1/08/21. outcome is yet to be determined as of 1/08/21.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,levothyroxine 50mg multivitamin,none,hypothyroidism,,none,"['Cardiac flutter', 'Cardiac monitoring', 'Chest discomfort', 'Electrocardiogram abnormal', 'Ventricular extrasystoles']",1,MODERNA,IM 930054,IA,61.0,F,"redness, swelling Used a hot towel",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,Losartan 50mg tab daily,None,Hypertension,,NKDA,"['Erythema', 'Swelling']",1,MODERNA,IM 930055,TX,37.0,F,"4 days after had a small itchy area after soreness lessened, then at day 9 and 10 noticed a small area at injection site of red, itchy, swollen red patch in same area of injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,PVT,Advil,,None,,"One time had an allergic reaction to a TB spot test, other than that no allergies","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 930056,NY,28.0,F,"PATIENT STATUS POST MODERNA VACCINE RCVD 1425. SITTING IN NURSE STATION, PATIENT HAS SOB, DIAPHORESIS, CHILLS. 1508 PATIENT IS TRANSFERRED TO EXAM ROOM FOR EVAL. BP 100/60. SHE REPORTS A TIGHTENING IN THROAT. EPIPEN 0.3MG ADMIN IM AT 1515. VITAL SIGNS 118/78. HR 109. 02 SAT 97% ON 2L 02. 1522- PATIENT CONTINUES TO REPORT A SORE THROAT BUT NO DIFFICULTY BREATHING. 1535 PT IS TRANSFERRED BY EMS TO HOSPITAL",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,"PANTOPROZOLE, BUPROPRION, MELOXICAM",,,,NKDA,"['Chills', 'Dyspnoea', 'Hyperhidrosis', 'Oropharyngeal pain', 'Throat tightness']",1,MODERNA,IM 930057,WI,33.0,F,Rash and itching ended up in hospital and was diagnosed with Cellulitis on injection site and is receiving antibiotics from PCP.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Injection site cellulitis', 'Pruritus', 'Rash']",UNK,MODERNA,SYR 930058,,57.0,F,"Pt received the Moderna Covid-19 vaccine on 1/4/21. After receiving her first dose she then called the Health Department and asked to receive the vaccine, because she is a Nurse Practitioner. She then came to the health dept on 1/7/21 and did not disclose that she had already received the vaccine 3 days prior, and she received another dose of the Moderna Covid-19 vaccine. The pt received a total of 2 Moderna Covid-19 doses only 3 days apart. The pt was contacted but states she did not feel the first shot so she did not think she actually received anything. That prompted her to get a second shot. She has not had an adverse effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,,,,,,"['Inappropriate schedule of product administration', 'No adverse event']",UNK,MODERNA,IM 930059,CA,36.0,F,"Approx 10-15 min post vaccine, pt began to c/o bilat foot numbness & flushing. NIBP 172/30, HR 90s. Benadryl 50 given IM. Pt discharged to ED, NIBP 157/111 HR 102.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,unknown,none,"cardiac murmur, HA, HLD, palpitations",,NKA,"['Flushing', 'Hypoaesthesia']",1,PFIZER\BIONTECH,IM 930060,IA,31.0,M,"Started feeling very fatigued around 6/7 PM on 1/7/21. Ate dinner shortly after and took my normal sleeping pills as previously listed. Around 12:30 AM on 1/8/21 I woke up feeling very cold. I got up, used the restroom and grabbed some acetaminophen (1000mg). I took the medication and started feeling very dizzy and light headed. After that all I remember is sitting on the kitchen floor feeling like my body was buzzing/tingling. My ears were also ringing really badly. I attempted to get up but was unable to get orientated for what I believe was about 15-30 minutes. I called my BF at 1:10 AM after I was able to get up and moving. I elected not to go to the ER because I didn?t want to directly expose myself to COVID. I stayed up for about another hour, drank some water and ate some crackers. I took 25mg of diphenhydramine and went back to sleep. The rest of the day up to writing this I have been very fatigued and achy. Mild dizziness and confused feeling. I didn?t hit my head but I have about a four inch scrape down my back and a small cut on my foot from the broken glass.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,OTH,"Aimovig 140mg injection monthly, administered Jan 1st, 2021 Zolpidem 10mg nightly Gabapentin 600mg nightly Irwin naturals power to sleep PM two capsules as directed on bottle, nightly D-amphetamine ER 30mg",None,Chronic migraines ADHD Insomnia Depression,,No known allergies,"['Confusional state', 'Disorientation', 'Dizziness', 'Fatigue', 'Feeling cold', 'Limb injury', 'Pain', 'Paraesthesia', 'Skin abrasion', 'Tinnitus']",1,PFIZER\BIONTECH,IM 930061,IL,45.0,F,"chills in evening after vaccination, chills next day in AM then nausea and body aches, temp 102.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,,,"Type 2 diabetes, high blood pressure and asthma","Flu shot, age 33-34, body aches for 2 days",Metformin,"['Body temperature increased', 'Chills', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 930062,FL,32.0,M,"Fatigue, mild fever (99.5) Onset of fatigue early in the morning, fever around midday.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,None,None,None,,NKA,"['Fatigue', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930063,CA,62.0,M,"Patient c/o Itchy rash over his abdomen, shortness of breath, itching inside his throat and feeling as if his throat was mildly closing. Patient received Benadryl 25mg IM, Solu-Medrol 125mg IV and Pepcid 20mg PO. Patient was sent out to ER for further evaluation. Patient returned from ER at 2349 with no new orders. ,No any acute distress reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,"Buspar30mg, Lisinopril20mg, Metformin 1000mg, Methadone 5mg,","Diabetes, High blood pressure, Acid reflux, Low back pain,","Asthma, Costochondritis, essential hypertension, Klinefelter syndrome, Schizoaffective disorder",,"Penicillin, Aspirin, Ibuprofen","['Dyspnoea', 'Rash', 'Throat irritation', 'Throat tightness']",1,PFIZER\BIONTECH,IM 930065,SC,36.0,F,"Patient had her first dose of the COVID vaccine and was waiting in the lobby when she asked another patient to get help. When staff arrived she was grey, dizzy, having difficulty breathing with rapid respirations and overall not feeling well. Pulse Ox was 88 on room air so she was placed on oxygen and the EpiPen was used. EMS was called. She began improving with the oxygen and after the 0.3mg of Epi. EMS transported her to the ER and at her request her boyfriend was notified.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Dizziness', 'Dyspnoea', 'Malaise', 'Respiratory rate increased', 'Skin discolouration']",UNK,PFIZER\BIONTECH, 930066,NV,67.0,F,"Mild symptoms the next day (12/31/2020): fatigue, low grade headache minor injection site soreness. I took Ibuprofen, rested, had lots of liquids, and was fine the day after (01/01/2021) No other symptoms until exactly one week later (01/06/2021). I noticed the injection site on my left arm was itching and a bit sore. A 5""x3"" red rash appeared at injection site. I took one Acetaminophen PM that night. The red rash is still there. These appear to be minor reactions but the red rash is never one I have had before with any vaccinations. It seems strange it didn't appear until a week later. No difference in skin lotion I have used. I wanted to report effects for data collection purposes since it is a new/emergency vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,OTH,"Levothyroxine, (daily), Sumatriptan (as needed), Magnesium (daily), Red Yeast Rice (daily), vitaminD3 (daily), Glucosamine Chondroitin (daily), Ibuprofen (as needed), Acetaminophen PM (as needed)",none,migraines (about 2x/month),,none known,"['Fatigue', 'Headache', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Rash erythematous']",1,MODERNA,IM 930067,TN,76.0,F,Patient called to notify that the patient's arm was red and hot to touch on 01/05/21. Patient took Benadryl at home and it gave it some relief.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/05/2021,13.0,PUB,none,none,none,,nka,"['Erythema', 'Skin warm']",1,MODERNA,IM 930068,NC,78.0,F,redness and fever at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,OTH,,,,redness and fever at injection site. flu shot 78 yrs of age,,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,SYR 930069,AL,36.0,M,"Pt was vaccinated at 1125 At 1157 pt was observed - with rash around neck, chest and back, dry mouth and slurred speech, heavy arms, tingling in arms. Pt was very hard to communicate with - could not articulate - pt was taken to the ER via wheelchair and examined.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Adderall XR 25 BID - last taken this morning Lexapro 10mg PO Qday - last taken last night,,,,"first dose - PFIZER pt reported feeling feeling tired, confused, and tinglining in both arms that started 30 minutes after first injection Toradol - pt reports feeling confused, lightheaded, lethargic after receiving IM Toradol 3 years ago","['Dry mouth', 'Dysarthria', 'Full blood count', 'Limb discomfort', 'Metabolic function test', 'Paraesthesia', 'Rash']",2,PFIZER\BIONTECH,IM 930070,CA,58.0,F,Severe Headache Rash starting on neck and chest Chills Fever Vomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Chills', 'Headache', 'Pyrexia', 'Rash', 'Vomiting']",1,PFIZER\BIONTECH,SYR 930071,LA,80.0,F,"Patient states she had complete loss of hearing for 2-3 hours the evening after receiving the vaccination. She states that she took a Tylenol dose, and her hearing came back to normal a few hours later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PHM,UNKNOWN,,UNKNOWN,,IODINE,['Deafness'],1,MODERNA,IM 930072,MD,52.0,F,Chills for hours body would not get warm. Left arm pit is swollen with some pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Vitamin D, Zinc",None,None,,None,"['Axillary pain', 'Chills', 'Feeling cold', 'Oedema peripheral']",1,MODERNA,IM 930073,WI,53.0,F,"Associate stated anxious to needles at 1400 and had flu vaccine anxiety in past. at 1403, felt sweaty and asked to lie down. 1405 had cold compress, 15 ounces apple juice, sat 40 minutes post vaccine. At 1440 ambulated to bathroom with assistance and stated she felt better at that time. Associate left to her work environment ( Lab) at hospital as she stated she was fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,none stated by associate,none stated,none stated,,none stated by associate,"['Fear of injection', 'Hyperhidrosis', 'Laboratory test normal']",1,PFIZER\BIONTECH,IM 930074,MO,62.0,F,"Fine pin point rash and itching noted 45 minutes after shot given. Rash noted to neck,spine,hips,upper back,upper chest and bend of both arms.Benadryl 25 mg OTC 1/6/21 and 1/7/21.Itching. Itching decreasing 1/8/21. Having copious side effects also of injection site pain,tiredness,headache,joint and muscle pain,nausea,lymphadenopathy and feeling unwell.1/6/21,1/7/21 but feeing better when tylenol 500mg ing system to relieve aches and pains",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,"Viactiv,Aspirin 81mg and B12 1000mcg",mouth and lip cold sores,,,"Demerol,Keflex,Versed, Latex,Cat dander,Spring pollens,ivy and sumac","['Arthralgia', 'Fatigue', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Malaise', 'Myalgia', 'Nausea', 'Pain', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 930075,WI,35.0,F,"12/24/2020 @ 0600: The site of the injection (right deltoid) was incredibly red, swollen, and extremely painful; the site was noticeably elevated from the base of skin. Never did I develop a temperature. This continued until 12/26/2020 when the symptoms dissipated. 1/5/2021 @ 0600: I woke up to my right arm feeling sore and area where I had received the vaccine was warm and a thin red circular outline could be seen. Also note that a few months ago I had injections in my legs due to vein insufficiency. Interestingly enough, during the same time frames, when my arm would become red and painful, so would my right knee.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,"Wellbutrin, Levothyroxine, Methylphenidate, Humalog & Lantus",none,"Type 1 Diabetes, Anxiety, Depression, Hypothyroidism",,NKDA,"['Arthralgia', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 930076,CO,44.0,F,"I came home around 5:30pm after receiving the injection at 3PM and felt very drowsy. I was drowsy and my head felt really heavy on my shoulders. After another hour at 6:30 pm, I felt a strong headache coming on. Throughout the evening I was drowsy and went to bed early. In the middle of night, I woke twice due to headaches. This morning 1/8/2020, my headaches continued even after I took 1000mg of acetaminophen at 11:00am. That was my first dose of any type of pain medication. I thought the side effects would go away therefore I delayed taking any pain medication. I usually do not have headaches and healthy. My arm is very sore at the injection site as compared to when I received the flu shot in November. It is almost 2:30pm almost 24 hrs from the injection and my headache continues.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Synthroid 75mcg,None,Hypothyroid,,Neomycin Thiermosol Gold Nickel Augmentin Grass,"['Head discomfort', 'Headache', 'Injection site pain', 'Sleep disorder', 'Somnolence']",1,MODERNA,IM 930077,AZ,27.0,M,"Major Headaches, nausea, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Advil, Tylenol, Ibuprofen, Nasacort, Pepto",,,First dose of Covid-19,,"['Headache', 'Nausea', 'Pain', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 930078,GA,54.0,F,"Patient complaints of tingling in left hand and tingling of lips 15 minutes after injection. BP 151-99, pulse 97, pulse ox 97%. Benadryl 25 mg 2 tabs by mouth administered. Vitals monitored for an additional hour and the patient denied tingling of lips and hands when leaving the clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,None,,History of stroke and HTN,,"Iodine, sulfa, eggs","['Paraesthesia', 'Paraesthesia oral']",1,MODERNA,IM 930079,TX,20.0,F,"Swelling of throat and tongue, anaphylaxis, hives, redness, swelling",Not Reported,,Yes,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,SCH,,,Mast Cell Activation Syndrome,Varicella and hep B,,"['Anaphylactic reaction', 'Erythema', 'Pharyngeal swelling', 'Swelling', 'Swollen tongue', 'Urticaria']",1,MODERNA,SYR 930080,NE,57.0,F,"On 12/29/2020 at approx. 1000 she reports having body aches in her shoulders and lower back. She denied any s/s prior to this other than a tender arm at injection site. She reports also noticing stiffness in her left hip area but with walking tended to help some. She medicated herself with Tylenol at that time. By 1300 she reports that she felt like she had Covid again. She reports having headache, pressure in her head and left ear area, fatigue and reports being afebrile. The above s/s were symptoms that she had experienced when diagnosed with Covid. She also reports that she had not fully recovered with her taste and smell and thinks that it may be some worse on 12/29/2020 then prior. She was not able to work on 12/30/2020 with Covid like s/s. On 12/31/2020 she returns to work feeling some better. On 01/04/2021 she presents to work with a softball size redness, hard to touch and feverish to touch area on her left deltoid area where she received her injection. She does report that on 01/01/2021 noticing a hardened area in the left deltoid but denies any other s/s. She was instructed to contact her PCP due to her questions regarding the taking of her 2nd Covid vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/29/2020,1.0,PVT,"Esterdiol, Multivitamin, Pravastatin, Fish Oil, Vitamin C, Zinc, Vitamin D, Calcium, Tumeric",She was diagnosed with Covid 11/17/2020. She returned back to work on 11/30/2020 experiencing severe exhaustion through 12/07/2020. She also reports that she had episodes of a racing heart rate since the diagnosis of Covid and had seen her cardiologist on 12/17/2020. She is too have a Cardiac evaluation with a stress test on 12/31/2020.,Left hip replacement 05/2019,,Sulfa and Morphine Sulfae,"['Arthralgia', 'Back pain', 'Ear discomfort', 'Fatigue', 'Head discomfort', 'Headache', 'Injection site erythema', 'Injection site induration', 'Joint stiffness', 'Pyrexia']",1,MODERNA,IM 930081,NE,42.0,F,"shoulder joint pain, injection was given in joint.... I am now on prednisone, physical therapy, if this doesnt help will need a MRI .",Not Reported,,Not Reported,Not Reported,,Yes,N,12/30/2020,12/31/2020,1.0,PVT,"birth control pill,",none,none,,"macrobid, sulfa, minocycline, cephalexin,codeine","['Arthralgia', 'Product administered at inappropriate site']",1,MODERNA,IM 930082,KS,70.0,M,"Rash on the chest, back and upper arms. Rash was rash, Scattered and raised. Ichy. Started 24 hours after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,SEN,,,,,NKA,"['Rash', 'Rash papular']",1,PFIZER\BIONTECH,IM 930083,,24.0,F,"Quarter sized mark at injection size that is erythematous, warm, and painful to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,UNK,Melatonin Valerian Root Lexapro Macrobid,UTI,,,Allopurinol Flomax Bactrim,"['Injection site erythema', 'Injection site pain', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 930084,IL,37.0,F,Headache Itching Hives Swelling Pain Redness Treatment Benadryl and prednisone,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,Sumatriptan Citalopram Famotadine Pantoprazole Fluticasone Allegra Birth control Sudafed Mucinex Aspirin,None,Migraine Acid reflux Depression Seasonal allergies,,None known,"['Erythema', 'Headache', 'Pain', 'Pruritus', 'Swelling', 'Urticaria']",1,MODERNA,IM 930085,MA,44.0,F,"Inadvertent administration of dose into triceps subcutaneous area, rather than IM deltoid.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,None,None,None,,None,['Incorrect route of product administration'],1,MODERNA,SC 930086,TX,77.0,M,Patient's spouse states that approximately 1.5 hours after receiving vaccine patient was at home and found to be confused and non- verbal. Unable to verbally express what was wrong. Spouse called into the clinic was triaged via phone and advised to go to the ER for further evaluation.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,Metoprolol Succinate 25 mg oral tablets,,"GERD, HTN, CAD, ED, BPH, Memory Loss, Hypercholesteremia",,Latex Sulfa Drugs,"['Aphasia', 'Arteriogram carotid', 'Computerised tomogram head', 'Confusional state', 'Full blood count', 'Laboratory test', 'Lipids', 'Magnetic resonance imaging head', 'Oesophagogastroduodenoscopy', 'Scan with contrast']",1,MODERNA,IM 930087,IL,41.0,F,"sore arm the first day, then fine. on evening of day 8, my arm was sore again, and itchy. the next morning it was red and swollen. it continues to be swollen and red, and it is spreading to a larger area of my arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PUB,na,na,na,,pcn allergy,"['Erythema', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Swelling']",1,MODERNA,IM 930088,FL,34.0,F,"about 5-10 minutes after administration, my lips began to move and shake uncontrollably and became tingling and a bit numb. Soon right after my heart rate was very fast, highest 160's. My throat felt weird but I never had any difficulty swallowing or breathing and my mouth, lips, or tongue never became swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,No,no,history of SVT (sinus ventricular tachycardia),,shellfish,"['Dyskinesia', 'Electrocardiogram', 'Heart rate increased', 'Hypoaesthesia oral', 'Oropharyngeal discomfort', 'Paraesthesia oral', 'Sinus tachycardia']",1,PFIZER\BIONTECH,IM 930089,IL,34.0,F,"received the covid vaccine 12/30/2020 that night I had a very bad sore arm lasted 3 days that night at around 6pm I experience tiredness, cold chills and body aches and a low grade fever a temperature was 99.8 I took a nap I typically never nap. My symptoms since the vaccine I have been feeling very tired id say more sleeping and eyes feeling heavy throughout the day and on and off headache I have had a cough which I have had lingering for the past month. These are my symptoms currently fatigue, tired and on and off headaches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,multivitamin,cough,,,shell fish,"['Asthenopia', 'Chills', 'Cough', 'Fatigue', 'Feeling cold', 'Headache', 'Hypersomnia', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 930090,OR,26.0,F,"Swelling, pain, hot to the touch, tenderness around vaccine site. Hives spreading all over body and face.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PVT,"Venlafaxine, Alprazolam, Birth Control pill",none,"Anxiety, Depression",,Cephalexin,"['Urticaria', 'Vaccination site pain', 'Vaccination site swelling', 'Vaccination site warmth']",1,MODERNA,IM 930091,,43.0,F,"Pt presented to Emergency department with left arm pain after receiving the Moderna COVID-19 vaccine roughly 3 days ago. Patient states she was injected, left shoulder Tuesday evening, 60 hours prior to evaluation. She had pain in the left shoulder since then, relieved with ibuprofen but recurrent and intense when the medicine wears off. She states that during injection she felt pain that went down to her middle digit. She has normal neurologic function, normal motor function, no obvious infectious symptoms, and exam is benign.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,None,No past medical history,No past medical history,,No allergies,"['Immediate post-injection reaction', 'Injection site pain', 'Pain', 'Pain in extremity']",1,MODERNA,IM 930092,WV,92.0,F,"Raised red area to deltoid, itching at site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,SEN,"Allopurinol, Fentanyl, Calcium Vitamin d3, Centrum Silver, Vitamin D, Flonase, Iron, Biofreeze, lexapro, modular protein, Neurontin, oxygen, senna plus, synthroid, toprol xl, uti state, vitmain c and zinc.",,"Alzheimer's, av block, acute on chronic CHF, COPD, CKD, DM II with diabetic poly neuropathy, anorexia, vitamin d def, idiopathic gout, OA, Vascular Dementia, Obstructive and reflexive uropathy, cardiomegaly, morbid obesity, osteoporosis, Anemia, dry eye syndrome, dyspnea, HTN CKD, hypothyroidism, Obstructive Sleep Apnea, Recurrent Pneumonia, Presbyopia, Biateral hearing loss, tachycardia, tinea ungums , Tinea capitis and barbae, hallus valgus, dysphagia, arthropathy, allergic rhinitis, hypokalemia, cardiac pacemaker, PVD, Spinal Stenosis, COPD, SOB, HLD, GAD, HTN, Constipation, GERD, Depression, Chronic Pain",,"codiene, buspar, cymbalta and tamiflu","['Erythema', 'Injection site erythema', 'Injection site pruritus']",2,PFIZER\BIONTECH,IM 930093,MI,42.0,M,Hives all over body and top lip swollen,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,PVT,"Xyosted, multi vitamin",No,No,,Bactrim,"['Lip swelling', 'Urticaria']",1,PFIZER\BIONTECH,SYR 930094,WI,42.0,F,got a rash all over my cheeks and chin and chest with a severe headache. 2nd day rash went to bottom half of my body and still on cheeks and chin with itching with red mark and swollen lymph nodes.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,Ibuprofen and tylenol,None,None,,"PCN, Sulfa, Bactrum, Latex, Meloxicam","['Erythema', 'Headache', 'Lymphadenopathy', 'Pruritus', 'Rash']",1,MODERNA,IM 930095,WA,56.0,F,Left shoulder pain and tenderness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/26/2020,6.0,WRK,None,None,None,,None,"['Arthralgia', 'Tenderness', 'X-ray limb']",UNK,PFIZER\BIONTECH, 930096,KS,45.0,F,"Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/7/2021 � Date: 1/7/2021 � Subjective Patient is a 45 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. � She denied any history of previous adverse reactions to vaccines. � She was given the Pfizer vaccination in the left deltoid muscle. � During her 15 minute waiting period after the injection, the patient began to experience throat tightness and sinus drainage. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. � This provider was notified of patient reaction and she was then assessed in the emergency bay area. � Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting. Pt took allegra this am for allergies. � ALLERGY REVIEW OF SYSTEMS: All other systems negative � � Previous Reactions: She states with first shot a few hours after her shot she had a rash on her mid back. and and lower extremities. Pt also had a head ache. Symptoms lasted 5 days. � � Objective � Vitals Vitals: � 01/07/21 1248 01/07/21 1303 01/07/21 1321 01/07/21 1334 BP: (!) 150/87 130/71 137/87 123/73 Pulse: 94 86 75 76 SpO2: 97% 99% 98% 99% � � � � Physical Exam Vitals signs and nursing note reviewed. Constitutional: Appearance: Normal appearance. She is well-developed. HENT: Head: Normocephalic. Jaw: There is normal jaw occlusion. Right Ear: External ear normal. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Musculoskeletal: Normal range of motion. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Findings: Rash (on chest) present. Rash is macular. Comments: Flushing over the cheeks and bridge of the nose. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Behavior is cooperative. Thought Content: Thought content normal. Judgment: Judgment normal. � � � Assessment/Plan Treatment included: antihistamines. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP.Pt told if symptoms worsen or changed she is to be seen in the ER. � Diphenhydramine 25 mg oral given at 12:55pm. � Pt okay to go home with dad driving at 14:22 pm. � � Electronically Signed 1/7/2021 2:03 PM � � �",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,"['Headache', 'Rash', 'Sinus operation', 'Throat tightness']",UNK,PFIZER\BIONTECH, 930097,PA,41.0,F,"Facial swelling, numbness of the lower left jaw, sore throat, coughing, congestion, sneezing, headache, tenderness and soreness at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,levothyroxine 75 mcg QD,none,hypothyroid,,"Imitrex, lactose intolerance","['Cough', 'Headache', 'Hypoaesthesia', 'Injection site pain', 'Oropharyngeal pain', 'Respiratory tract congestion', 'Sneezing', 'Swelling face']",1,MODERNA,IM 930098,IN,39.0,F,"The area is swollen, red, hot. I had chills, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,None,Hypothyroidism,None,,Amoxicillin. Sulfa,"['Chills', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Myalgia']",1,MODERNA,SC 930099,TN,30.0,F,"Severe flu like symptoms, fever over 101, chills, body aches, headache, nausea/loss of appetite, fatigue, soreness in the arm from injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,OTH,"birth control, multi-vitamin, vitamin D, claritin, flonase, finasteride",none,none,,none,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Influenza like illness', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 930100,TX,59.0,M,"Got the vaccine in left arm on 12/31, sat for 15 minutes for observation. After leaving and driving home, started feeling worse pain in left arm and numbness around the left ear and left cheek. Went back, they examined and observed for another hour, then released. It went away and returned; has been intermittent since. Left V2/3 distribution",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,PVT,Flomax 0.4mg daily,none,BPH,,NKA,"['Hypoaesthesia', 'Malaise', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 930101,PA,38.0,F,"While waiting ini observation area pt reported ""not feeling well"" was given water and asked to stay for aditonal amoutn of time. SOrtly after she reported ""feeling like i am goinog to pass out"" . Lightheaded dizzy, no other physical complaints. Pt is cool, lips pale.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Dizziness', 'Feeling cold', 'Malaise', 'Pallor']",2,PFIZER\BIONTECH,IM 930102,FL,59.0,F,"Following 15 minutes of monitoring after receiving the COVID19 vaccine, the patient experience dizziness upon standing and reported tingling in lower limbs. Patient was monitored for an additional 20 minutes and symptoms resolved. Patient had no other complaints.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,"Adderall, estradiol cream",None known,None known,,None known,"['Dizziness postural', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 930103,OR,44.0,F,"Patient was given covid vaccine 1 at 1:10 PM and had face and neck urticaria within 5 min. Denied throat tightness, or breathing difficulties. Was taken to ED for observation. PMHX includes anxiety, HTN; Meds: Amlodipine, acyclovir; Allergies to Betadine, Erythromycin, Fentanyl, Minocycline, PCN, Versed, and reactions include dyspnea and Hives",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Amlodipine, acyclovir",,"anxiety, HTN",,"Betadine [Povidone-Iodine] Rash Erythromycin Unknown � � Causes ""stomach pain"" Fentanyl Hives and Rash � � With moderate sedation on 7/19/19 Minocycline Pruritus and Dyspnea � � Scratchy throat Penicillins Hives and Rash Versed [Midazolam Hcl] Hives and Rash","['Tryptase', 'Urticaria']",1,PFIZER\BIONTECH,IM 930104,WI,27.0,F,"1 week after injection, injection spot was very itchy, redness, and raised.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA,SYR 930105,CO,33.0,F,"Redness, swelling, warmth at injection site, area ~2 in by 4 in on 1/8/21 and was about half the width and length on 1/7/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,Oral contraceptive,None,None,,None,"['Erythema', 'Injection site warmth', 'Swelling']",2,PFIZER\BIONTECH,IM 930106,VA,45.0,F,"Fatigue, fever 100.7, moderate headache, chills, muscle ache, joint pain, restlessness, fatigue, wooziness, mild nausea, mild abdominal pain. No asthma symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,"Asthma- albuterol, symbicort, Flonase, sertraline",Asthma Anxiety,Asthma Anxiety,,"Sunflower seeds, shellfish, pollen, molds, animal dander","['Abdominal pain', 'Arthralgia', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Restlessness']",2,PFIZER\BIONTECH,IM 930107,OR,39.0,F,"within 5 minutes of the vaccine she developed diffuse itching and flushing. described similar reaction which presented to hives with both penicillan and quinapril. never had respiratory, cardiovascular, or gastrointestinal symptoms. BP and HR normal. no hives developed. itching resolved within 10 minutes. she did take diphenhydramine upon onset of itching and then required several other doses throughout the night for itching. never developed hives or other systemic symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Nucala,none,asthma autoimmune disorder,,penicillin quinapril,"['Flushing', 'Pruritus']",7+,MODERNA,IM 930108,,46.0,M,"pt resturned several hours after injection and stated that he was feeling chest tightness, and slightly SOB Pt was taken to ER for evaluation",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,methotrexate,,,,Septra Phenylpropanolamine,"['Blood pressure increased', 'Chest discomfort', 'Dyspnoea', 'Electrocardiogram normal', 'Full blood count normal']",2,PFIZER\BIONTECH,IM 930109,FL,93.0,F,She began with an earache and dizziness. Pain got so severe that she could no longer take it. Went to the doctor which she was put on pain medications. Went to ER on 1/6 and on 1/7 went to her PCP. Still in severe pain.,Not Reported,,Not Reported,Yes,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,"Insulin, Jardiance, Januvia, Levemir, Novalog, Lipitor",kidney failure,Diabetes,,nokidney failure,"['Dizziness', 'Ear pain']",1,PFIZER\BIONTECH,IM 930110,KS,50.0,F,"After injection, was feeling flushed, dizzy, and off balance. When I got home, I was ok until about 4am on Sunday January 3rd, 2020, I woke up with chills, fever of 102.00, nausea, sore throat, body was achy and left arm was severely bruised and sore. I was like this for Sunday & Monday, finally Monday night around 7pm, my fever broke. I was finally able to return to work on Tuesday, I was still quite tired and worn out from the weekend.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,PVT,"Wellbutrin, Citalopram, Estradiol, Omeprazole, & Xarelto",,Chronic back issues & pulmonary embolism,,Celebrex & Keflex,"['Chills', 'Contusion', 'Dizziness', 'Fatigue', 'Flushing', 'Gait disturbance', 'Impaired work ability', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 930111,AK,26.0,F,"Lightheadedness, pounding headache, overall body soreness, feeling hot and/cold, sweating when hot, chills when cold, extreme fatigue and weariness. As of the writing of this form, I am still experiencing some lightheadedness, and this morning, I felt very warm, but I overall feel much better.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Fluoxetine, liquid form",,"Eosinophilic esophagitis, corn allergy",,"Corn derivatives, such as corn starch","['Chills', 'Dizziness', 'Fatigue', 'Feeling hot', 'Feeling of body temperature change', 'Headache', 'Hyperhidrosis', 'Pain']",2,PFIZER\BIONTECH,IM 930112,AZ,58.0,F,"Fever, to 101.8, chills, body aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Armour thyroid, vitamin D, calcium, vitamin B12",None,None,,None,"['Chills', 'Fatigue', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,IM 930113,IN,52.0,F,"Fever, chills, nausea, lymph node enlargement with pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Losartan, HCTZ, Metoprolol, Norvasc, ASA, Loratidine, Tylenol, Ibuprofen, Pepcid",None,"HTN, Seasonal Allergies",,"Shellfish, Latex","['Chills', 'Lymph node pain', 'Lymphadenopathy', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,IM 930114,NM,38.0,F,"Patient complained of dry, tight, scratchy throat after receiving vaccine. Patient monitored and instructed to monitor at home.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,None documented,Unknown,Anxiety,,"Latex, penicillin, gluten, wheat","['Dry throat', 'Throat irritation', 'Throat tightness']",1,PFIZER\BIONTECH,IM 930115,FL,35.0,F,"No adverse events until day 8 post vaccination. Woke up in the morning with a rash over my right deltoid where the vaccination was administered. It was itchy and painful, and developed into a 2-inch circumferential welt. This was present for approximately 36 hours and disappeared without treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/01/2021,8.0,PVT,None,None,Migraines,,None,"['Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Urticaria']",1,MODERNA,IM 930117,PA,59.0,F,"Oral Herpes outbreak, severe",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,UNK,,,,Smallpox,,['Oral herpes'],UNK,PFIZER\BIONTECH,IM 930118,KS,29.0,F,"Arm soreness, chills, achiness, lymphadenopathy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,UNK,Prenatal vitamins,None,None,,None,"['Chills', 'Lymphadenopathy', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 930119,CT,48.0,M,"Chills, fever, night sweats, nausea, bad headaches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,"Sumatriptan, propecia",None,Migraines,,None,"['Chills', 'Headache', 'Nausea', 'Night sweats', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930120,PR,37.0,F,Local pain,Not Reported,,Not Reported,Not Reported,,Not Reported,,,,,OTH,,,,,Shellfish,['Pain'],1,MODERNA,IM 930121,IL,25.0,F,"Light red rash about 2in high, 3in wide at widest part at site of injection. Noticed at around 8am 1/8/21, size has not changed as of time of report. Slightly warm to the touch, no pain, no white streaks, no raised areas, and no soreness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/08/2021,9.0,WRK,"Lamictal, Concera, Xanax, Ambien (been prescribed for multiple years)",None,None,,Coppertone Sport Sunscreen (developed hives),"['Injection site reaction', 'Injection site warmth', 'Rash erythematous']",1,MODERNA,IM 930122,CT,47.0,F,"Vaccine given on 12/30/21 Pain only at injection site for 3 days (Advil relieved it), then back to normal 01/08/21, woke up with moderate pain, swelling, redness, and very minor itch (no rash) at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/08/2021,9.0,PVT,"Estradiol, Buspirone, Lamotrigine, Montelukast, Dextroamphetamine, Breo, Women's One a Day multi-vitamin, Vitafusion D3",,"asthma, allergies",,"grass, bees, lobster, dust, pet dander, mold","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,UN 930123,MT,50.0,F,"muscle pain, chills, joint pain, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Arthralgia', 'Chills', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,IM 930124,AR,45.0,F,"Redness on face, neck, and arms, Tachycardia, HTN",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PHM,lisinopril 10mg qd,none,none,"Minor adverse event from first shot (runny nose, pain at injection site)",nkda,"['Erythema', 'Hypertension', 'Tachycardia']",2,PFIZER\BIONTECH,IM 930125,WA,51.0,F,"Sore arm x 3 days. 1 week post vaccination, Noted R armpit painful. No swelling palpable. On day 10post vaccine, noted lymphnodes on R side of neck painful and swollen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,PVT,"Atorvastatin, lisinopril/hctz. estradiol transdermal patch",none,HTN,,none,"['Axillary pain', 'Lymph node pain', 'Lymphadenopathy', 'Pain in extremity']",1,MODERNA,IM 930126,TX,57.0,F,Raised red rash the size of a silver dollar at the site of the injection. The rash feels hard underneath the skin.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"Atorvastatin, Levothyroxine, Lisinopril, Gabapentin, Omeprazole, L-Methyfolate, Trintellex, Methotrexate, Tylenol",rheumatoid arthritis,rheumatoid arthritis,,Sulfa based medications. Triple antibiotic ointment,"['Injection site induration', 'Injection site reaction', 'Rash erythematous', 'Rash papular']",1,MODERNA,IM 930127,FL,56.0,F,Tingling of your tongue and face was flushed. All symptoms resolved within one hour without taking any Benadryl.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Multiple Vitation Melatonin Daily Triamertine Daily Atenolol at night,Cold Symptoms (not COVID),Mitral valve issue Hypertension,,PCN Sulfa Wasp (bee sting),"['Flushing', 'Paraesthesia oral']",1,MODERNA,IM 930128,FL,58.0,F,I received my second dose of Pfizer COVID19 in my left arm . It was administered just under the acromion process. I am currently experiencing posterior shoulder pain with pain radiating down my arm to my fingers. I have been seen by my primary provider and have been prescribed gabapentin and Tylenol 3. I will follow up with my provider on 01-10-21.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,"Desvenlafaxine ER 50 mg, Fluticasone 50 mcg, Rosuvastatin Calcium 10mg Fenofibrate 145 mg Omeprazole 40 mg Bupropion SR 150mg Losartan Potassium 50 mg Carvedilol 3.125",,HTN Hyperlipidemia Depression Anxiety,,Sulfa - anaphylaxis,"['Arthralgia', 'Pain']",2,PFIZER\BIONTECH,IM 930130,TX,38.0,F,"Symptoms - ? evening of 1/7 began with abd pain and diarrhea, morning of 1/8 reported to work and left half way through shift after feelings of chills, nausea. Patient reports she went home, took her temperature 99.7, took a nap and then re-took temperature at 1:40 pm (Tmax 100.8), no meds taken. Last day of work and shift - ? today Home remedies? - nap Any improvement? ? mild improvement Recommendation? Patient educated to continue to monitor her symptoms and to rotate Tylenol and motrin for fever and pain management, patient verbalized back understanding. Patient educated to continue to manage her symptoms and to follow the guidelines outlined in the Illness in the Workplace Policy. Patient denied COVID-19 exposure without proper PPE and denied travel. Patient verbalized back understanding and denied further questions at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Abdominal pain', 'Body temperature increased', 'Chills', 'Diarrhoea', 'Impaired work ability', 'Nausea', 'Somnolence']",UNK,PFIZER\BIONTECH, 930131,IL,41.0,F,"Patient reports seconds after receiving the vaccine she felt a strange sensation in her chest which she has a difficulty characterizing but describes as ""a strange sensation"". Vitals at that time demonstrated tachycardia and hypertension which she was referred to the ED for further evaluation. She does admit that she has anxiety and felt this may be contributing to the symptoms. She reports she is already starting to feel improved. She is noted to have some redness over her left ear and feels it is a little warm but no other rash. She denies any associated shortness of breath, dizziness or lightheadedness, arm or jaw pain, associated nausea, vomiting, back pain, lip or tongue swelling. No fevers, chills, or cough. Patient was given one dose of diphenhydramine 50 mg PO Once and monitored in the emergency room. Symptoms completely resolved and was hemodynamically stable. Patient discharged home from the emergency room.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Medication list from November 2019- compliance/adherence not assessed during encounter. Aspirin, atorvastatin, fexofenadine, fluticasone nasal spray, hydroxychloroquine, hydroxyzine, losartan, montelukast, mycophenolate, prednisone, sertra",,"history of lupus and associated chronic kidney disease, hypertension",,Hydrocodone,"['Anxiety', 'Electrocardiogram normal', 'Erythema', 'Feeling abnormal', 'Hypertension', 'Immediate post-injection reaction', 'Sinus rhythm', 'Skin warm', 'Tachycardia']",1,MODERNA,IM 930133,NE,33.0,F,"She reports not having any symptoms other than a tender deltoid area after her vaccination. She reports feeling fine the morning of 12/24/2020 when she went to work. Pt. reports approx. 4 hours after being at work that she became dizzy, clammy, noted head pressure and spots in front of her eyes as if she were going to pass out. She reports that she did have breakfast prior to coming to work. Noted her blood pressures to be elevated 141/102. She was monitored for 45 mins. taking BP every 15 mins. ranging from 155/112 with the lowest obtained being 150/90. With the drinking of fluids at the end of the 45 mins. she did feel like she was getting back to her normal self. She was instructed due to elevated BP to seek care at her clinic with her PCP. She did return to work on 12/25/2020 reports that she felt much better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,"Diclofenac Sodium, Omeprazole, Multivitamin, Abilify, Celexa, Flonase Allergy Relief, and Xanax",Denies any illness at time of vaccination or up to one month prior of vaccine.,Hx. of anxiety and Psoriatic Arthritis,,Sulfa,"['Blood pressure increased', 'Cold sweat', 'Dizziness', 'Head discomfort', 'Injection site pain', 'Visual impairment']",1,MODERNA,IM 930134,MI,25.0,F,"I had a skin reaction (welts) over my shoulders, stomach, and back. I took OTC anti-itch cream. The reaction only lasted two days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,PVT,none,none,exercise induced asthma,,none,"['Skin reaction', 'Urticaria']",1,MODERNA,IM 930135,MA,48.0,F,"15 min after vaccination dizzy, nausea, 30 min later sob and tight chest, vomit (x1) . F/U with ER visit pt left ER after having EKG exam, pt was not discharged and left at own will. Symptoms continue for patient dizziness, nausea, chest tightness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,OTH,"Synthroid, metformin",,,cannot recall vaccine but does recall memory of adverse event,,"['Chest discomfort', 'Dizziness', 'Dyspnoea', 'Electrocardiogram normal', 'Nausea', 'Vomiting']",1,MODERNA,IM 930136,MT,50.0,F,"muscle pain, chills, joint pain, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Arthralgia', 'Chills', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,IM 930137,TX,68.0,F,"Patient was vaccinated on 12/29/20, started having itching, redness, and swelling at injection site on 1/05/21. Went to ED on 01/08/21 with worsening itching, redness, and swelling at injection site. Treated in ED with steroids and sent home on oral steroids same day.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/05/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 930138,NY,25.0,F,"Light sensitivity, headache, fever of 101F. Symptoms resolved,",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Headache', 'Photophobia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930139,KY,46.0,F,Employee states she woke up this morning and injection site was swollen (about size of an egg) and super tender. Also states itching. Also noted that she started having ear pressure and slight congestion and had covid test on 1/6/21 that was positive.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/08/2021,9.0,PVT,,,,,,"['COVID-19', 'Ear discomfort', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,MODERNA,IM 930140,NY,26.0,F,"Fever, chills, body ache, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Lexapro, Wellbutrin, melatonin",None,None,,None,"['Chills', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 930141,MI,60.0,M,Onset of swelling in neck. Reported via phone that he has 2 lumps that began yesterday. He also said he started experiencing an allergic rash on his back. Advised to seek medical care.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/07/2021,2.0,OTH,,Had Covid 2-3 months prior,,,,"['Dermatitis allergic', 'Rash', 'Swelling']",UNK,PFIZER\BIONTECH,IM 930142,FL,68.0,F,Patient experiencing Chest pain and elevated troponin. Patient taken to the cath lab and treated for suspected stress induced cardiomyopathy.,Not Reported,,Not Reported,Yes,,Not Reported,U,01/05/2021,01/08/2021,3.0,OTH,Nortriptline Multivitamin,,,,No Known Allergies,"['Chest pain', 'Stress cardiomyopathy', 'Troponin increased']",1,PFIZER\BIONTECH,IM 930143,MD,55.0,F,"Tingly lips, felt like throat was swelling. I was able to breath fine. Given Prednisone and Prevacid and symptoms went away.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Benazapril/HCTZ 20/12.5 md Rosuvastatin 40mg Bupropion Multi vitamin Omega 3 Apple Cider gummies,Double ear infections 2 weeks prior,High Blood pressure High cholesterol,,Augmentin,"['Paraesthesia oral', 'Pharyngeal swelling']",1,PFIZER\BIONTECH,IM 930144,NM,40.0,F,"I had arm soreness that I needed to take Tylenol and I was exhausted no energy I had a hard time walking around the hospital I almost fell asleep on my desk. I fell asleep that night and felt fine the next day! Advanced maternal age because I'm 40 so I'm high risk, Low on Vitamin D3 early in my pregnancy, beginning of Dec I was lightly anemic, due date Feb 9th",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"prenatal, iron, Vitamin D3",no,migraines,,no,"['Asthenia', 'Fatigue', 'Gait disturbance', 'Pain in extremity', 'Somnolence']",1,PFIZER\BIONTECH,SYR 930145,MO,40.0,M,"Strong chills, shaking, fever up to 101 and head ache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,SEN,Pantoprazole 40 MG,COVID recovered on 1/2/2021,,,Sulfa,"['Chills', 'Headache', 'Pyrexia', 'Tremor']",1,MODERNA,IM 930147,VA,52.0,M,SKIN RASH ON LOWER LEG BELOW THE CALF TO THE TOP OF THE FEET BOTH RIGHT AND LEFT. STARTING PEDNESONE ORALLY QID X 3 DAYS THEN TAPER,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,UNK,none,none,none,,nka,['Rash'],1,MODERNA,IM 930148,IL,53.0,M,"Server pain at the injection site to the point it is hard to move the arm, and it woke me up when I rolled onto it. Migraine headache with visual pain and nausea. I have taken Tylenol and ibuprofen for the pain and discomfort and I have also been icing the injection site. I missed work today because of the migraine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Amlodipine, Digestive enzymes, Escitalopram, Vitamin B-12, Omeprazole, Truvada, Vitamin D-3, Tylenol, Ibuprofen, Vitamin C, Gabapentin.",None,"HTN, Chronic Bronchitis, Gastric bypass, GERD, Depression, Anxiety.",,"Penicillin, Ace Inhibitors, Meperidine, Nifedipine.","['Eye pain', 'Impaired work ability', 'Injection site pain', 'Migraine', 'Mobility decreased', 'Nausea']",2,PFIZER\BIONTECH,IM 930149,TX,30.0,F,"Rash on left arm started appearing on 1/7 and has gotten larger on 1/8. Pain in arm started mid day on 1/8, not just at injection site, but throughout all of the top half of my arm and into the left shoulder/shoulder blade. There is a raised bump on the left arm as well that just appeared on 1/8. Arm aches and itches too.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PHM,,,,,none,"['Arthralgia', 'Injection site pain', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Rash']",1,MODERNA,SYR 930150,TX,26.0,F,"DPH (after the Lot number); I started with a very severe pounding tension headache - 6:00 am; very severe fatigue; very severe arm pain at injection site. And then unable to complete daily functions: do to headache; suffered from headache - took one gram tylenol to address a low grade fever that day and the headache, too. fever subsided with tylenol. Headache was relentless; I tried 600 mg of ibuprofen as well to treat headache with no success; Started to suffer severe pain; couldn't open eyes from pressure of headache. Went to ER due to never having such a severe headache before. Tests did not show pathology that would cause headache. Was given one liter of IV fluids. Was given 25 mg of Benadryl ; 10 mg of Compazine. Along with toradol. And 20 meq of potassium. Also tested for covid and was negative. And discharged home. FOllowing day: mild headache and with resolution of left arm pain. By the 27th it felt like headache was resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,PUB,none,headaches,headaches,,none,"['Computerised tomogram', 'Fatigue', 'Full blood count', 'Injection site pain', 'Loss of personal independence in daily activities', 'Metabolic function test', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tension headache']",1,MODERNA,IM 930152,MT,45.0,M,"chills, no appetite, symptom free today",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/08/2021,2.0,PVT,,,,,,"['Chills', 'Decreased appetite']",1,PFIZER\BIONTECH,IM 930153,MI,41.0,M,ITP Plt 2,Not Reported,,Yes,Yes,1.0,Not Reported,N,01/05/2021,01/07/2021,2.0,PUB,Atorvastain 10mg Levothyroxine 112mcg Prilosec 20mg Insulin,,"Insulin dependent Diabetes HX of ITP 2014, in remession",,PCN,"['Condition aggravated', 'Immune thrombocytopenia', 'Platelet count decreased']",1,PFIZER\BIONTECH,IM 930154,OH,60.0,M,Notified today that he passed away. No other details known at this time.,Yes,01/08/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/08/2021,3.0,PUB,unknown,unkown,unknown,,Sulfa,['Death'],1,MODERNA,IM 930155,UT,39.0,F,"Employee reports 1/4 he had a sore arm, later that night HA, fever, chills. 1/5 1600 headaches progressed to migraine with extreme fatigue. 1/6 evening he went to ED due to symptoms and history of blood clots in the brain. CT was done in the ED. It showed signs of COVID in the CT chest. COVID test negative. 1/7 AM SOB and cough started. HA continues but manageable, dizziness and a crawling feeling under skin. 1/8 AM tightness in chest, crawling under skin increased, HA, dizziness and slight bodyaches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Warfarin Lipitor Tylenol,None,High Cholesterol Unknown clotting disorder,,None,"['Chest discomfort', 'Chills', 'Computerised tomogram head normal', 'Computerised tomogram thorax abnormal', 'Cough', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Formication', 'Headache', 'Migraine', 'Pain', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative']",UNK,MODERNA,SYR 930156,NY,88.0,F,"Received 2 doses of this vaccine today, no adverse outcome as of this time",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,SEN,Acetaminophen Amlodipine Docusate Sodium Remeron Ensure Enlive,Dysphagia Hypertension Hyperlipidemia Dementia,Dysphagia Hypertension Hyperlipidemia Dementia,,NKA,"['Extra dose administered', 'Inappropriate schedule of product administration', 'No adverse event']",1,MODERNA,IM 930158,CA,39.0,F,"headache, myalgia, nausea, vomiting, and facial swelling x3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/18/2020,1.0,PVT,"Krill oil, biotin, apple cider vinegar",none,none,,mild allergy to crabs,"['Headache', 'Myalgia', 'Nausea', 'Swelling face', 'Vomiting']",1,PFIZER\BIONTECH,IM 930159,MI,59.0,F,"Strong stomach cramps leading to diarrhea, about 5 instances, followed by strong stomach cramping with blood clotting discharge with 9 instances, lasting about 16 hours, with the clotting reducing each time",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/01/2021,,PVT,None,None,None,,None,"['Abdominal pain upper', 'Diarrhoea', 'Haematemesis']",1,MODERNA,IM 930160,,35.0,F,"Pt states she started feeling flushed, started getting hives around neck, and tightness of the right leg",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,MIL,,,,,,"['Flushing', 'Limb discomfort', 'Urticaria']",2,PFIZER\BIONTECH,IM 930161,OH,40.0,F,5 x 6 cm erythematous macular weal over left deltoid,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,WRK,none,none,none,,none,"['Injection site rash', 'Injection site urticaria', 'Rash macular']",1,MODERNA,IM 930162,,51.0,F,"Patient received second Pfizer vaccine on 1.5.21. On 1.7.21 at 2:40pm the patient experienced aches and weakness that evening, took tylenol with relief. 1/8/21 patient woke up in the middle of the night with fever, blister on the inside of her lip, and her right cheek twitching. 1/8/21 patient went to PCP to be checked out. Discovered redness and bruising at the injection site. Patient has had relief with tylenol and zyrtec.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,,,,,TDAP reaction 21 years ago. Developed a knot and unable to move arm for 2 weeks.,"['Asthenia', 'Injection site bruising', 'Injection site erythema', 'Lip blister', 'Muscle twitching', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930163,KS,34.0,F,Was seen at ER,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,,,,,"sulfa, hydrocodone, tree nuts",['Unevaluable event'],1,MODERNA,IM 930164,NM,60.0,M,"Approximately 2 hours after receiving the vaccine I felt a heat flash, people setting in the area asked if I was OK as my face was red. It cleared in approximately a minute. The 2nd heat flash came on about 5 to 10 minutes later and cleared about a minute later. The 3rd heat flash came on about another 5 to 10 minutes, again clearing at about 1 minute. Next I felt like my head was in a fog, found it very hard to focus, and was forgetting what I was doing. I walked over to the office, my supervisor asked if I was ok as she said it looked like my eyes were glazed over, my head was still in a fog. This cleared by 2:30 p.m.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Rosuvastatin calcium, Acyclovir, Vit C, Vit A, Vit D, D-mannose, Magnesium, B-complex, Turmeric, Cosamin, Zinc, CoQ10",,Arthritis,,Anacin,"['Disturbance in attention', 'Erythema', 'Feeling abnormal', 'Glassy eyes', 'Hot flush', 'Memory impairment']",2,PFIZER\BIONTECH,IM 930165,UT,21.0,F,"within 5 minutes of recieving the vaccine, felt light headed, nauseated and had a dry mouth. Pt was placed supine with legs up and monitored. Symptoms resolved within 15 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,,,,,,"['Dizziness', 'Dry mouth', 'Nausea']",1,MODERNA,IM 930166,MT,34.0,F,welt on injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,PVT,,,,,,['Urticaria'],1,PFIZER\BIONTECH,IM 930167,TX,65.0,F,Treated in ED the same day as vaccination for left facial tingling and numbness. Diagnosis from ED of Left 5th nerve Transient Palsy. Resolved in 72 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Hypoaesthesia', 'Paraesthesia', 'Paralysis']",1,MODERNA,IM 930168,VA,28.0,F,"Small red hives, itching, bilateral arms and chest. Noted 30 min after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,,"none, per pt","none, per pt",,Cats and dogs allergy,"['Erythema', 'Pruritus', 'Urticaria']",1,MODERNA,IM 930169,SC,29.0,F,"Tachycardia-160 for about 10-20 minutes about 10-15 after injection, HR 120-130 for about 1 hour, clamminess, shaky, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,None,,None,"['Cold sweat', 'Dizziness', 'Tachycardia', 'Tremor']",1,PFIZER\BIONTECH,IM 930170,WI,39.0,F,"one week after injection the injection site was itchy, red, swollen, and warm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA,SYR 930171,IL,20.0,M,Fever 102.9 at 1:45pm Ibuprofen 400mg given at 1:50pm,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,SEN,,,,,,['Pyrexia'],1,MODERNA,IM 930172,ID,39.0,F,"Left arm lymph soreness. Left leg (sometimes in both) warm sensation with numbness and tingling below knee in calf and foot, not constant. Standing and walking helps relieve symptoms at times but seems to be more constant then on 1/6 and 1/7. Encouraged client to seek emergency medical treatment as to determine cause of the numbness and tingling.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PUB,no,no,no,,no,"['Feeling hot', 'Hypoaesthesia', 'Limb discomfort', 'Lymph node pain', 'Paraesthesia']",1,MODERNA,IM 930173,MT,34.0,F,welt on injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/08/2021,2.0,PVT,,,,,,"['Injection site reaction', 'Urticaria']",1,PFIZER\BIONTECH,IM 930174,FL,44.0,F,"Following administration of COVID19 vaccine (Pfizer), patient experienced a ""scratchy feeling"" in her throat and feeling that her throat might be closing up. She denied any other symptom. Patient had no history of anaphylaxis. Patient was monitored until symptoms resolved. No treatment was required. Note: Patient received second dose of vaccine (from same lot# EH9899) on 1/6/21 and no adverse reactions were observed after 30 minutes monitoring. Patient reports that she felt much less anxious when receiving the second dose of vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,PVT,None known,None known,None known,,None known,"['Throat irritation', 'Throat tightness']",1,PFIZER\BIONTECH,IM 930175,KS,18.0,F,"Notes COVID VACCINE CLINIC Subjective Patient is a 18 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She denied any history of previous adverse reactions to vaccines and denies reaction to her first dose. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience throat tightness. She denied difficulty breathing, difficulty swallowing, wheezing, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms and tongue swelling. � ALLERGY REVIEW OF SYSTEMS: Patient denies facial swelling, chest tightness, shortness of breath, rash and dizziness + throat tightness: � � Previous Reactions: Denies previous reactions to vaccinations. � Objective � Vitals Vitals: � 01/08/21 1143 01/08/21 1204 01/08/21 1227 BP: (!) 144/89 131/81 104/76 Pulse: (!) 125 (!) 109 99 Temp: 98 �F (36.7 �C) � � SpO2: 99% 99% 98% � Physical Exam Vitals signs and nursing note reviewed. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling of lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. � Assessment/Plan Treatment included: benadryl 25mg po and solumedrol 125mg IM. Follow up response to treatment: good. Patient had improvement in throat tightness. Does mention being lightheaded after. Patient discharge: Stable to go home and follow up with PCP. Patient called a friend for a safe drive home. She was instructed to go home and rest for the remainder of the day. Denies having any symptoms on discharge. Discharged at 1229. � If she experiences any adverse symptoms in the future, advised to F/U in ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,['Throat tightness'],UNK,PFIZER\BIONTECH, 930176,OK,45.0,F,"Chills, fever, body aches, joint pain, painful lymph nodes in armpit, headache, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Famotadine - 300 mg daily Vitamin D - 5000 IU,none,none,,none,"['Arthralgia', 'Axillary pain', 'Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 930177,CA,47.0,F,"4 cm diameter circular erythema at the injection site, axillary lymphadenopathy on the vaccine side, scapular and neck pain on the same side as vaccine injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/07/2021,7.0,WRK,none,none,none,,none,"['Arthralgia', 'Injection site erythema', 'Injection site lymphadenopathy', 'Neck pain']",UNK,MODERNA, 930178,WI,44.0,F,shoulder pain in the joint space causing paresthesia in the hand and arm with intermittent pain in the forearm. loss of full range of mobility in the shoulder. this has been ongoing x 1 week.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/04/2021,2.0,WRK,omega 3 multivitamin MSM,,,,,"['Arthralgia', 'Mobility decreased', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 930179,MN,35.0,F,"L axilla swelling x 5 days, not improving. VEARS completed. Advised her to see MD as this is most likely from the injection, but could also be from another cause - including Covid infection.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PVT,,,,,,['Lymphadenopathy'],2,PFIZER\BIONTECH,IM 930180,OH,45.0,F,"On 1/6/2021 Patient noticed itching at injection site. On the next day 1/7/2021, Patient stated that the injection site was red, swollen, warm to touch and sore to touch. Patient followed up with her health care provider. Health care provider recommended that Patient take ibuprofen for the swelling and also prescribed an antibiotic, but Patient was told to wait to take the antibiotic for 2-3 days to see if it resolves without taking the antibiotic. Patient stated that she originally had pain at the injection site on the evening of the injection (12/29/2020) and the next day (12/30/2020, but it resolved after that.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PUB,"Claritin, probiotic, prilosec",none,"High Blood Pressure, seasonal allergies",,none,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 930181,PA,27.0,F,"Moderna COVID?19 Vaccine EUA. States she experienced fatigue 24 hours after and immediately felt like she had swelling/lump under her skin. States last night she started with itchiness over the injection site. Today she has developed warmth and redness. She denies discharge, fevers, shortness of breath, cough, wheezing, swelling of mouth or throat, n/v, or rash elsewhere. She denies receiving any other vaccines in that arm since then or injury to that arm. She reports the nurse did clean her arm with alcohol swab prior to vaccination and a bandage was placed. She did report her symptoms to employee health and was told to be seen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,PVT,? Omeprazole 20 MG Oral Capsule Delayed Release (PriLOSEC) Take 1 Cap by mouth daily as needed for Heartburn. 1 hour before the first meal of the day 30 Cap 1 ? fluticasone (FLONASE) 50 MCG/ACT nasal spray Administer 2 Sprays into each nost,None,"Dysmetabolic syndrome X � HTN (hypertension), benign � Insulin resistance � Lynch syndrome � Migraine � Obesity, morbid (HCC)",,NKDA,"['Fatigue', 'Injection site erythema', 'Injection site pruritus', 'Injection site warmth', 'Mass', 'Skin swelling']",1,MODERNA,IM 930183,OH,42.0,F,"Developed red area with in duration and pain to touch initially a single lesion on right forearm on 1/5/21. Initially lesion got larger over first 12 hours. It then became itchy on 1/6/21 in the morning with a second smaller lesion just proximal to the first one. Thought it was hives. On evening of 1/6/21 developed similar lesions on left knee and posterior left ankle. Took Allegra and Zyrtec that evening. Lesions on right forearm looked like bruises on 1/7/21 with resolution of lesion on left knee. Lesion on left ankle has stayed red, swollen, itchy, and painful. Did not respond to Allegra, Zyrtec, or benadryl. I went to primary care provider on 1/8/21 at 2:45 PM. I had labs drawn and received prescription for steroids.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,"Multivitamin, fiber supplement, Vit D supplement, glucosamine-chindrotin, melatonin, losartan, buspirone, pantoprazole, fluoxetine",No,"Hypertension, anxiety, depression",,Latex,"['Antinuclear antibody', 'Blood immunoglobulin E', 'C-reactive protein', 'Erythema', 'Full blood count', 'Liver function test', 'Pain', 'Pruritus', 'Red blood cell sedimentation rate', 'Rheumatoid factor', 'Skin lesion', 'Tenderness']",1,MODERNA,IM 930184,IL,70.0,F,fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,SEN,acetaminophen aripiprazole aspirin daily multivitamin famotidine fluticasone lecithin levothyroxine loratadine calcium plus vitamion d senna plus vitamin c,none,moderate intellectual disabilities hypothyroidism osteopenia seasonal allergies depression,,NKDA,['Fatigue'],1,MODERNA,IM 930185,MA,29.0,F,"Pain in left arm in injection site and under arm, armpit and side of breast. Pain feels like shards of glass. By day 3, swelling in left arm and lymph nodes under arm, armpit, and side of breast. Tingling in left arm down to fingertips and ""dead arm"" feeling.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/08/2021,4.0,WRK,"Sertraline, Velivet oral contraceptive, PRN Ativan",None,Anxiety/Depression,,Penicillins,"['Axillary pain', 'Breast pain', 'Injection site pain', 'Lymphadenopathy', 'Monoplegia', 'Paraesthesia', 'Peripheral swelling', 'Swelling']",UNK,PFIZER\BIONTECH,IM 930186,TN,21.0,F,"Vomiting, nausea, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,None,Nond,None,,None,"['Chills', 'Nausea', 'Vomiting']",1,MODERNA,IM 930187,WA,18.0,F,"Patient had seizure 10 minutes after injection. No history of seizures, but brain tumor resection about a year ago. 911 was called; EMS evaluated and had patient transported to hospital",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,None known,None,None. Had brain tumor resection end of 2019,,None,['Seizure'],1,MODERNA,IM 930188,NM,60.0,M,"Approximately 2 hours post vaccination a heat flash came over my body, co-workers setting around me asked if I was ok as my face was red, cleared about 1 minute later. About 15 minutes later a 2nd heat flash came over my body and cleared about 1 minute later. About 15 minutes later the 3rd heat flash came across my body and cleared about 1 minute later. Approximately 30 minutes later my head was in a fog, I could not focus, thoughts left my mind. When returning to my office my manager asked if I was ok and said my eyes were glossed over and my face was red. All this cleared around 2:30 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Rosuvastatin calcium, acyclovir, Vit A, Vit B, Vit D, D-mannose, Magnesium, B-complex, Turmeric, Cosamin, Zinc CoQ10",,Arthritis,,Anacin,"['Erythema', 'Feeling abnormal', 'Glassy eyes', 'Hot flush', 'Mental impairment']",2,PFIZER\BIONTECH,IM 930189,WI,54.0,F,7 days after injection patient developed redness and itching around injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/07/2021,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus']",UNK,MODERNA,SYR 930190,FL,25.0,F,"Rash that stayed near the site of injection, but has traveled a little inferior of the site. Just bumps - not itchy or hot to touch Nausea that has stayed since the day after the injection. But I've been able to keep food down. Severe stiffness in left arm that made it hard to lift arm - only stayed for 2 days and then it cleared",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,,,iron-deficiency anemia,,Vancomycin - seizures; seasonal allergies,"['Injection site rash', 'Musculoskeletal stiffness', 'Nausea']",1,MODERNA,IM 930191,UT,24.0,F,"covid vaccine given at 1309 approv 3-5 minutes later felt cold, lightheadedness, tingling, nausea. No shortness of breath VSS. No rash, swelling. Feels cold to touch, pale. placed in supine position with blanket. Not as lightheaded Nausea improving s/p ondansetron 4 mg ODT @ 14:00.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,WRK,clindamycin-benzoyl peroxide; spironolactone 50 mg BID; viorele daily; mupirocin 2% topically daily; albuterol prn; adderall 20 mg TID; bupropion XL 300 mg;,none,"depression, vocal fold dysfunction, acne","Flu vaccines: since youth has developed hypotension, syncope after flu vaccines. Has been able to tolerate other vaccines. Ha","Flu vaccine: hypotension/syncope Alcohol: hives, syncope Haldol: worsening anxiety","['Dizziness', 'Feeling cold', 'Nausea', 'Pallor', 'Paraesthesia', 'Peripheral coldness']",1,MODERNA,IM 930192,IL,33.0,F,"Developed fever of 100.6, chills and was tachypneic. Presented to Hospital Emergency department on 1/8/21 at 6 am. Discharged at 10am.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,,,,,Latex,"['Chest X-ray normal', 'Chills', 'Electrocardiogram normal', 'Laboratory test normal', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tachypnoea']",2,PFIZER\BIONTECH,IM 930193,SD,28.0,F,"Arm started swelling around site. Sore, achy pain radiating down the arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"Lexapro Pamelor Mirena Hair, skin, and nails Zinc Flax seed oil",,Raynauds anxiety depression,HPV vaccine,norethindrone-eth estradiol bacitracin-polymyxin B,"['Injection site swelling', 'Pain', 'Pain in extremity']",1,MODERNA,UN 930194,NM,39.0,F,Itching/redness at injection site and up neck. Administered 50mg Benadryl PO . Staff called and observed for 30 min. Discharge to husband's care.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,"atorvastatin 20mg qhs, isosorbide mononitrate 60mg ER qmorning, multivitamin, omperazole 20mg qday, sertraline 50mg qday, tizanidine 2mg prn muscle spasm,",unknown,"anxiety and depression, coronary artery spasm, hyperlipidemia,",,Latex (anaphylaxis),"['Erythema', 'Injection site erythema', 'Injection site pruritus']",1,PFIZER\BIONTECH,IM 930195,VA,24.0,F,"Around 4pm I started to feel sick and i started to feel really cold, chills. I got a migraine so I laid down. Around 7pm I started feeling nauseous and started throwing up around 730p. Around midnight I started getting really hot. I checked my temp it was 101. 230a I woke up and checked temp it was 102.9. Symptoms lasted until around noon next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,no,COVID Pos- 12/21/20,no,,bananas,"['Body temperature increased', 'Chills', 'Feeling cold', 'Feeling hot', 'Malaise', 'Migraine', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH, 930196,MD,42.0,F,Lymph node swelling right axillary,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,01/03/2021,18.0,WRK,"Alive women?s vitamins, probiotic",,,,,"['Axillary mass', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 930197,AZ,35.0,F,"Body aches, fatigue, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Sertraline,,none,,none,"['Fatigue', 'Headache', 'Pain']",UNK,PFIZER\BIONTECH, 930198,OH,32.0,F,"Worsening pain, soreness, red raised warm welt 3cm diameter, malaise worsening getting into hours 20-24 post injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,OTH,"Venlafaxine, multivitamin",None,Depression/ anxiety,,None,"['Erythema', 'Malaise', 'Pain', 'Skin warm', 'Swelling', 'Urticaria']",1,MODERNA,SYR 930199,CO,30.0,F,"0756:15 minutes after immunization she stated that she felt itchy. Her back felt itchy. Hives were noted on her left arm. Felt she was going to pass out. 0800: Taken to ED. Evaluation revealed tachycardia, c/o throat constriction, wheezes heard on auscultation of lungs, hives noted on chest. Treated with Decadron, Benadryl, Famotidine and Ativan. She was observed for 5 hours before being discharged.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,UNKNOWN,NO,NO,,STATED ALLERGIES TO MULTIPLE ANTIBIOTICS.,"['Dizziness', 'Pruritus', 'Tachycardia', 'Throat tightness', 'Urticaria', 'Wheezing']",1,MODERNA,IM 930200,IA,39.0,F,hives/rash on arm,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/27/2020,01/07/2021,11.0,UNK,multivitamin,None,None,,None,"['Rash', 'Urticaria']",1,MODERNA,SYR 930201,IL,20.0,M,fever 102.9 at 1:45pm 1/8/21 ibuprofen 400mg given 1:50pm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,SEN,,,,,,['Pyrexia'],1,MODERNA,IM 930202,IN,32.0,F,"Very sore arm starting day of administration lasting for 2 days; resolved. Headache and fatigue on day of vaccine starting about 4 hours after administration; resolved by the time I woke up the next morning. Lymphadenopathy and tenderness in the armpit and supraclavicular nodes on the same side the vaccine was administered starting 1/1/2021, four days after the vaccine was administered and is not yet resolved, although the tenderness started to improve after 1 week on 1/7/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,PVT,One a day Women?s Vitamin D3,None,Seasonal allergies,Only arm soreness at injection site with previous vaccines,None,"['Fatigue', 'Headache', 'Lymphadenopathy', 'Pain in extremity', 'Tenderness']",1,MODERNA,SYR 930203,CA,30.0,F,"25 minutes after the administration of COVID-19 (Moderna) vaccine, reported complaints of throat tightening and difficulty swallowing, respiratory effort unlabored, no retractions, facial or lip swelling noted. Denied any GI symptoms or rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,unknown,unknown,unknown,,"reported history of allergic reaction to Toradol injectable, developed a rash all over face that was treated with Benadryl .","['Dysphagia', 'Throat tightness']",1,MODERNA,IM 930204,CA,67.0,M,"High fever first two days ranging 101.7 to 103.9 F, and severe fatigue and body aches all over and loss of appetite. Fever was highest around 2AM to 7AM. Symptoms still continue more than 48 hours after vaccination. Important: I had Covid infection in March 2020 with2 weeks of high fever and cough and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/06/2021,5.0,PVT,"Olmesartan, Atenolol, Aspirin 81mg, Levothyroxine, Lipitor",No active illness,"CAD, Hypothyroid.",,None Known,"['Decreased appetite', 'Fatigue', 'Pain', 'Pyrexia']",1,MODERNA,IM 930205,PA,61.0,F,Patient developed itchy rash right A/C space and distal. She reported she has had this reaction before to vaccines and brought Benadryl with her. Resolved after 15 minutes,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,Reports previous rash to other vaccines,['Rash pruritic'],UNK,MODERNA,IM 930206,NM,39.0,F,Itching/redness at injection site and up neck. 50mg Benadryl PO given. Rapid Response called and observed for 30 min. Discharged to husband's care.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,"atorvastatin 20mg qhs, isosorbide mononitrate 60mg ER qmorning, multivitamin, omperazole 20mg qday, sertraline 50mg qday, tizanidine 2mg prn muscle spasm",unknown,"anxiety and depression, coronary artery spasm, hyperlipidemia",,Latex (anaphylaxis),"['Erythema', 'Injection site erythema', 'Injection site pruritus']",1,PFIZER\BIONTECH,IM 930207,TX,59.0,F,"Arm is red, swollen, painful, 3in wide in1/2 long in size.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PHM,"Lexapro 20mg, Wellbutrinxl300mg, ambien10mg, Singulair10mg, Xyzal5mg, Flovent110, Neurontin300mg.",no,"asthma, depression",,no,"['Erythema', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,SYR 930208,NY,44.0,F,"Pain, swelling, redness, extreme induration and tenderness at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/31/2020,30.0,PVT,None,None,None,,NSAIDs,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 930210,CA,32.0,F,"Patient experienced numbness from shoulder to finger tips starting 5 minutes after the injection. 15 minutes later, numbness decreased and pt feels tingling in hand and fingers. ""It's like I fell asleep on my hand.""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,Ibuprofen PRN (twice per month); Airborne gummies,None,Dermatitis/eczema,,None,"['Hypoaesthesia', 'Injection site hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 930211,,41.0,F,Headache and vomiting nausea and gastro problems,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,WRK,,,,,,"['Gastric disorder', 'Headache', 'Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH, 930212,,53.0,F,2nd dose was given on day 15 after first dose. No adverse event occurred.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,['No adverse event'],2,PFIZER\BIONTECH,IM 930213,OH,25.0,F,"I felt fine the rest of the day after I received the vaccine. However, I woke up at 4am the next day with intense cold chills, suspected fever (no thermometer to confirm), and it felt like my arm had been stabbed (much worse pain than usual flu vaccine discomfort). I took some ibuprofen and Nyquil. The next morning when I woke up I felt extremely fatigued and had whole body muscle aches. The cold chills returned around 2pm. I had a slight head ache. I took some Dayquil and rested. The 2nd day after my vaccine I still had some fatigue and muscle aches, but no more episodes of cold chills or fevers. I continued to take ibuprofen and Dayquil. The 3rd day after my vaccine I woke up feeling a bit more back to normal and the pain at my injection site was pretty much gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Sprintec,COVID-19 at end of November 2020,,,"Mild allergy to apples, peaches, pears, cherries, kiwis","['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 930214,WV,57.0,M,"Patient received 1st dose Moderna COVID19 on 12/30/20. On 1/7/21 he noticed itching at injection site, then on 1/8/21 he noticed solid circular redness and warmth at injection site. Area is tender to touch. There is right axillary lymphadenopathy as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,"Ibuprofen prn, MegaMen Joint formula",none,osteoarthritis,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth', 'Lymphadenopathy', 'Tenderness']",1,MODERNA,IM 930216,NM,60.0,M,"Approximately 11:00 am I got crazy chills, put on my coat, and turned a heat lamp on, this lasted about 30 minutes. After the chills my mind went in to a fog, found it very hard to concentrate, and felt like I was moving in slow motion. Also had some GI upset, but discharge. The fog lasted until 4:00 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/08/2021,2.0,PVT,"Rosuvastatin calcium, acyclovir, Vit A, Vit B, Vit D, D-mannose, Magnesium, B-complex, Turmeric, Cosamin, Zinc CoQ10",,Arthritis,,Anacin,"['Abdominal discomfort', 'Chills', 'Feeling abnormal']",2,PFIZER\BIONTECH,IM 930217,NY,37.0,F,"About 16 hours after injection (woke up the next morning) with myalgias, headache, chills, fever to 100. Feeling flu like.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/08/2021,7.0,PVT,None,None,None,,None,"['Chills', 'Headache', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 930218,MN,17.0,F,Patient was administered the Moderna vaccine despite being only 17 years old and the CDC not recommending the vaccine for people under 18 years old.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,SEN,,,,,NONE,['Product administered to patient of inappropriate age'],1,MODERNA,IM 930219,GA,31.0,F,Redness and swelling at the injection site as well as soreness when raising arm in both deltoid and tricep.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/08/2021,11.0,PHM,,,,Fever with TDAP at age of 18,,"['Injection site erythema', 'Injection site swelling', 'Pain']",1,MODERNA,IM 930220,,50.0,F,"itching, welp",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,"['Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,IM 930221,FL,39.0,F,"Headache, Shortness of breath, Chills, Body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,"Losartan-HTZ, Trintellix, Lamotrigen",No,"Hypertension, Anxiety",,No known allergies,"['Chills', 'Dyspnoea', 'Headache', 'Pain', 'SARS-CoV-2 test negative']",1,MODERNA,IM 930222,MS,23.0,F,Preauricular lymphadenopathy and tenderness initially noted on the R side. Progressive bilateral tenderness prompted symptom reporting.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,Prozac Adderall,N/a,ADHD,,N/a,"['Lymphadenopathy', 'Tenderness']",1,PFIZER\BIONTECH,IM 930223,NY,54.0,F,"COVID 19 vaccine received 12/23/20 left deltoid. She has been experiencing left jaw/TMJ joint pain since Sunday 1/3/20 worse in the morning,. patient describes it as a dullness on the left side of face. Denies any trauma to area. No hx of TMJ. Denies any facial droop, or dry eye, no weakness. She tried NSAIDs with no improvement, however pain with opening her mouth.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,01/03/2021,11.0,PVT,,,,,"Cephalosporin, Compazine","['Arthralgia', 'Facial discomfort', 'Oral pain', 'Pain in jaw']",UNK,PFIZER\BIONTECH, 930224,WA,41.0,F,"HIVES STARTED AFTER TWO DAYS OF COVID VACCINE . STILL HAVE HIVES, TAKING ZYRTEC AND BENADRYL",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/05/2021,2.0,PHM,"LEVOTHYROXINE 75MCG, VITAMIN B12 1000MCG",NONE,THYROID DISEASE,,PENICILLIN,['Urticaria'],1,MODERNA,IM 930225,NJ,57.0,F,"Swollen, redness, itchiness, hard to touch was felt that evening of the vaccine and its getting bigger in diameter. Its the 8th day and it is throbbing and seems like the redness is getting bigger in diameter. It is hard and hot to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,Fish oil Cambigan (eye drop) Prednisolone Acetate 1% (eye drop),,,,Lansoprazole Delayed-release Amoxicillin Clarithromycin LATEX,"['Erythema', 'Pain', 'Pruritus', 'Skin warm', 'Swelling', 'Tenderness']",1,MODERNA,IM 930226,AL,37.0,F,"5 min after injection: radiating nerve pain down left arm. 5 hours after: sore LT upper arm and LT mid-rib cage. Next morning 01/06: arm less sore, LT rib cage stabbing pain to take a deep breath; some RT rib cage tenderness; rib cage pain worse with prolonged sitting. Unable to lay flat or on sides. Only able to lay probe or with upper body elevated. Noticed congestion mainly at night and early morning. 01/07: arm tender; still experiencing some LT rib cage pain with deep breaths; still experiencing discomfort with laying flat on back or on sides. Congestion mild but noticed it during the day, as well. Everything tastes bland except spicy foods which were intolerable. Tested for COVID, both negative. 01/08: Woke up with chills and night sweats. LT rib cage tender, no problem with deep breaths. Left side of neck stiffness. Sudden onset of right side moderate sore throat/jaw pain/ear pain, happened within minutes. Congestion still present.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Tylenol PRN Adderall 15mg BID PRN Valtrex 500mg QD Calcium/Vitamin D supplement Melatonin 10mg PRN HS,None,GERD Depression Anxiety Headaches,,Sulfa Sensitivity to latex powder,"['Chills', 'Discomfort', 'Ear pain', 'Injection site pain', 'Musculoskeletal chest pain', 'Musculoskeletal stiffness', 'Neuralgia', 'Night sweats', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Pain in jaw', 'Painful respiration', 'Respiratory tract congestion', 'SARS-CoV-2 test negative', 'Taste disorder', 'Tenderness']",1,MODERNA,IM 930227,FL,63.0,F,Red rash adjacent to upper arm injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,"hydroxychloroquine, zinc, vit c, b complex, vit d",UTI,IGA and IGM levels low,,cefipime,"['Injection site rash', 'Rash erythematous']",1,MODERNA,IM 930228,NY,88.0,F,Received two doses of Moderna vaccine today,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,SEN,ACETAMINOPHEN AMLODIPINE DOCUSATE SODIUM REMERON ENSURE ENLIVE,DYSPHAGIA HYPERTENSION HYPERLIPIDEMIA DEMENTIA,DYSPHAGIA HYPERTENSION HYPERLIPIDEMIA DEMENTIA,,NKA,"['Extra dose administered', 'Inappropriate schedule of product administration']",1,MODERNA,IM 930229,PA,28.0,F,Patient reported dizziness with flushing and rapid heart rate. VS 97.1 68 20 118/80. Resolved after 15 minutes. Patient also reported she just drank rapidly a double expresso coffee.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Dizziness', 'Flushing', 'Heart rate increased']",1,MODERNA,IM 930230,CT,22.0,F,"Moderna COVID-19 Vaccine EUA At about 10:00pm Wednesday, I started to have a headache and feel tired. My temperature was mostly normal (99.4F) when I went to bed around 2:00am. When I woke up at 12:00pm Thursday, my temperature was 103.9F. By 12:30pm, it was 102.9F. I had a very bad headache, sore throat, nausea, and some light-headedness. My fever went down throughout the day with 2 doses of Tylenol at 1:00pm and 6:30pm. The sore throat, nausea, and light-headedness resolved during the evening, but my headache was constant until I went to bed. Today (Friday), I woke up with a slight headache but no fever or other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,none,none,none,,none,"['Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Oropharyngeal pain', 'Pyrexia']",1,MODERNA,IM 930231,CO,30.0,F,"My jaw, cheeks and wrists went numb. It lasted around 30-40 minutes and then went away.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Aller-tec,None,Anovulation,,None,"['Hypoaesthesia', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 930232,,51.0,M,2nd dose was given on day 15 after first dose. No adverse event occurred.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,['No adverse event'],2,PFIZER\BIONTECH,IM 930233,TX,25.0,M,Patient reported fever of 101 degrees and went to the ER due to previous history of seizures due to fever. Received Tylenol in the ER and fever subsided.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PHM,,,,,,['Pyrexia'],1,MODERNA,IM 930234,CO,23.0,F,"Immediately following the vaccine, I got chills, and my face tingled. I developed tonsillitis. Had to take a day off work for a COVID test, was negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,WRK,Birth control.,,,,Penicillin,"['Chills', 'Immediate post-injection reaction', 'Mononucleosis heterophile test', 'Paraesthesia', 'SARS-CoV-2 test negative', 'Streptococcus test', 'Tonsillitis']",1,PFIZER\BIONTECH,IM 930235,CO,44.0,M,"Hospital on 1/2 - then again on 1/5, transferred and admitted to hospital, discharged 1/6 Abnormal reflex/weakness back pain paresthesia and weakness of legs abdominal pain evaluation for possible GBS post covid 19 vaccine",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/30/2020,01/02/2021,3.0,OTH,Multivitamin daily Ambien 5mg daily/nighttime,,History of Bells Palsy,,,"['Abdominal pain', 'Asthenia', 'Back pain', 'Computerised tomogram spine', 'Muscular weakness', 'Paraesthesia', 'Reflexes abnormal']",1,MODERNA,IM 930236,CO,43.0,F,"Approximately 2 minutes following the injection client complained of ""tingling"" in mouth and lips. No visible ""rash/hive"" or swelling present. Able to swallow without difficulty. Vital signs within normal limits except for b/p noted as 150/110. States b/p has been elevated prior to this time. Oxygen saturations remained at 99%. Noted as being ""hot"" no flushing observed. Chewable Benadryl 50 mg administered and EMS contacted. Patient stated during this time that she had previously taken inhalers (both albuterol and steroid) prior to the clinic and admitted to having chronic breathing problems. Referred to Emergency Department. Refused ambulance and was taken to ED by private car.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,"Albuterol Inhaler, Steroid Inhaler",None Noted,"None Noted on screening however did verbalize chronic respiratory problems once the ""reaction"" occurred",,None Noted,"['Blood pressure increased', 'Feeling hot', 'Paraesthesia oral']",UNK,MODERNA,IM 930237,NE,48.0,F,"She reports on the evening of 12/29/2020 that she noted her arm/injection site was uncomfortable so took Tylenol. She comes to work on 12/30/2020 and by 1200 c/o's of chilling, extreme severe body aches, headache, feels like she has the flu, c/o's being tired but reports that she is afebrile. Pt. was instructed to contact her PCP and she reports that she was seen in the clinic on 12/30/2020. She reports being afebrile in the clinic but upon returning to her home she had a temp. of 101.6. On 12/30/2020 she reports having a temp spike of 103.6 and reports feeling as if she had ""Covid all over again"". She reports not being able to return to work until 01/04/2021 due to cont. s/s of body aches, headache, and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,"Metformin, Vitamin D, Tylenol, Migraine medication but uncertain of name, Gaviscon tablets.",On 11/10/2020 was diagnosed with Covid-19.,"Diabetes Type 2, Seasonal allergies that aggravate her asthma and has Psoriatic Arthritis but has not taken any Humera for approx. 6 months.",,"Seasonal allergies, Codeine and Biaxin","['Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Pain']",1,MODERNA,IM 930238,MA,33.0,F,"Headache, muscle/joint pain, low fever 99.4, chills, two episode of presyncopal events, and nausea. This started at 10pm 1/6 the night of the vaccine and continued untill Friday 1/8 12 noon. It is now the evening and my arms and back are still sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Citalopram,,,,Compazine,"['Arthralgia', 'Back pain', 'Chills', 'Headache', 'Myalgia', 'Nausea', 'Pain in extremity', 'Presyncope']",2,PFIZER\BIONTECH,SYR 930239,PA,60.0,F,"09:40 patient was in the car going home, reported nasal stuffiness and scratchy throat 10:00 returned to Vaccine Clinic; c/o above, received 50 mg oral Benadryl (VS, pulse ox and EKG wnl) 10:10 complained it was difficult to swall0w, 0.3mg Epinephrine via auto injector administered, peripheral IV started, 250 ml NS infused; ambulance called 10:20 ambulance arrived 10:29 patient transported to Hospital 1600 called patient who was just leaving the hospital; per patient she received oral steroids, Albuterol inhaler; discharged on Benadryl, oral steroids and orders to carry an Epi Pen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,,,,,,"['Dysphagia', 'Nasal congestion', 'Throat irritation']",1,MODERNA,IM 930240,IL,22.0,M,fever 102.3 at 1:45pm tylenol 650mg given at 1:55pm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,SEN,,,,,,['Pyrexia'],1,MODERNA,IM 930241,CA,61.0,F,Petechiae and itching at the injection site 9 days after injections,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/04/2021,8.0,PVT,Synthroid,None,Hypothyroidism,,None,"['Injection site haemorrhage', 'Injection site pruritus']",1,MODERNA,IM 930242,VA,43.0,F,"I fever 102.2 , weakness, fitage , chills, head aches and arm sores. 48 hours recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/17/2020,1.0,PVT,Metformin 1000 mg twice daily lavetalol 200 mg twice daily Vitamin D and B12,no,Diabeties High Blood Pressure,,no,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 930243,IN,55.0,F,"Extreme fatigue, considerable head congestion, sore throat, lots of fever blisters developed on mouth",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,UNK,"Metformin, Atacand, jareiance, advair, Singulair",None,"Diabetic, asthma",,"IVP iodine dye, PCN","['Fatigue', 'Head discomfort', 'Oral herpes', 'Oropharyngeal pain']",1,MODERNA,IM 930244,OH,44.0,F,"@ 8:56AM Nauseated, but reported no breakfast Prior to leave she said she was feeling ok to leave.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,,,,,"Penicillin, Keflex",['Nausea'],UNK,MODERNA,IM 930245,SC,40.0,F,Patient was given Covid Vaccine. She went to the waiting area to sit for the 15 min wait. She then came to the front desk to inform us that her heart rate was elevated and wanted to speak to a nurse. We then notified the nursing staff and took her to a room to be evaluated. After about 15-20 min nursing staff asked front desk to call 911.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,,,,,['Heart rate increased'],1,PFIZER\BIONTECH,IM 930246,UT,29.0,F,"Caregiver (CG) received the Moderna Vaccine ( lot # 037k20a) and the next day had high fevers and severe angioedema in my mouth and lips. I contacted employee health and my manager and made an appointment to see my PCP. Worked on 01/02/2021 and received the vaccine around 0800. CG is a NP and self-prescribed prednisone 50mg X2 days, ending 01/05/2021 which has improved the swelling. CG was planning to follow up with her provider 01/06/2021-notes not available in icentra @this time. CG is planning NOT to receive 2nd shot. CG missed work r/t SE. LOA packet sent to CG",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,WRK,,,,,,"['Angioedema', 'Pyrexia']",1,MODERNA,IM 930247,WA,31.0,F,"15 min after vaccine administration I was extremely dizzy/nearly fainted this lasted for 25 minutes. 2 days later I developed some redness at the sight of injection/itchiness. This got better. On day 7 after getting the vaccine I developed a firm, raised, HOT and extremely itchy area at the site of injection. This is measuring at 5cm by 5 cm on my Left deltoid. This continues to get larger and larger. I have also had daily headaches since the vaccine was given. I seen a doctor who recommended calling the CDC who then advised me to complete a VAERS report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,WRK,None,None,None,,None,"['Dizziness', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site reaction', 'Injection site warmth', 'Presyncope']",1,MODERNA,IM 930248,NY,45.0,F,"Pain, redness, swelling, extreme induration and tenderness, axillary pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,None,None,None,,None,"['Axillary pain', 'Erythema', 'Induration', 'Pain', 'Swelling', 'Tenderness']",1,MODERNA,IM 930249,,54.0,F,"12/28: Received Moderna Vax?developed some swelling and redness to right upper arm (injection site) Since Dec. 28 to current, still has the redness (bigger than quarter size), itchiness, and some swelling. She?s been taking over the counter meds for now.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 930250,CA,37.0,F,"1310c/o nausea 1312 vitals taken BP 156/85 P111 O2 sat100% 1317 still c/o nausea. Vitals BP 14./84 P101 MD stat called. 1318 c/o itching in head 1321 c/o hard to breathe. 1322 MD arrived. 1323 stated nausea subsiding. 1324 BP 121/81 P77 PO2 99 1327 Pt stated felt ""normal"" MD stated was ok to leave.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,,,,states was nauseated 2 hours after first vaccine,"Almond, coconut, Doxycycline, Walnut nut",['Nausea'],2,PFIZER\BIONTECH,IM 930251,KY,27.0,F,"Mild congestion starting the night of injection The day after injection I experienced a low grade fever, chills, extreme muscle soreness, headache, and soreness at the injection site. These symptoms lasted approx. 24 hours and then subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Lo loestrin birth control daily fluoxetine 5mg daily,none,none,,no known allergies,"['Chills', 'Headache', 'Injection site pain', 'Myalgia', 'Pyrexia', 'Respiratory tract congestion']",1,MODERNA,IM 930252,IL,56.0,F,Patient presented to the ED with complaints of mild diarrhea that started the day she received her vaccine. Doctor prescribed Lomotil and probiotic with instructions to follow up if diarrhea still present after 1 week.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,,['Diarrhoea'],1,MODERNA,IM 930253,WA,54.0,F,"10 minutes after injection patient was concerned she was having tightening in her throat. BP stable, lungs CTA. 50mg oral Benadryl administered and within 7 minutes patient reported feeling better. Patient waited an additional 20 minutes and then left.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Not known specifically. Patient stated after the fact that she takes xanax and oxycodone.,None known,Not known,,None known,['Throat tightness'],1,MODERNA,IM 930254,FL,66.0,F,Shot hurt. Arm was sore during the day. Hurt when I rolled over in bed Woke up with it sore and swollen. Hurt to try and hit golf club so didn?t play golf Cannot straighten arm straight up Hurts when I touch it. Feeling fine otherwise. Happy I received the shot.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,Atorvastatin 10 mg Levothroxine 75 mg Centrum Silver Women 50 mg Caltrate 600+D3 Vitamin D 1000mg,None,None,,Shellfish,"['Injection site pain', 'Pain in extremity', 'Peripheral swelling', 'Tenderness']",1,MODERNA,SYR 930255,NM,38.0,M,"Started having Nausea, vomiting and profuse sweating after vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,none,,,,Vicodin,"['Hyperhidrosis', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 930256,OH,48.0,F,Throat swelling following vaccination. Epipen administered at time of adverse event.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,,,Asthma,,,['Pharyngeal swelling'],UNK,MODERNA,IM 930257,MI,71.0,F,"Client expressed symptoms of allergic reaction evidenced by tingling in tongue approximately 10 min after Pfizer COVID vaccine at 2:32 pm. Client's VS monitored and airway assessed. VS within normal limits, airway patent, client alert and oriented. Client self administered Benedryl (at 2:36 pm as encouraged by registered nurse. Monitored client for ~50 min, VS remained stable, client remained alert and symptoms of tinging tongue diminished at 3:21 pm. Client left care of nurses and clinic at 03:27 pm after allergy symptoms were resolving and client was stable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,"Verapamil, maxide, advair, spiriva, albuteral, singulair",,"Dx asthma, hypertension",,"Latex, diluent in allergy shots, dilaudid, tetracycline",['Paraesthesia oral'],1,PFIZER\BIONTECH,IM 930258,,44.0,M,Dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 930259,CA,62.0,F,"Blurred vision, numbness in the mouth and high blood pressure. Benadryl 25 mg PO was administered approximately 1 hour post vaccination. Employee was instructed to see primary attending physician.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,SEN,"Synthroid 50mcg, multivitamins, vit C, zinc, Advil 2 x 250mg (night prior), Benadryl 25mg","Hypothyroidism, hx of COVID-19",Hypothyroidism,,NKA,"['Hypertension', 'Hypoaesthesia oral', 'Vision blurred']",1,MODERNA,IM 930260,TX,32.0,F,Low Heart Rate Very Low Blood Pressure Sweaty Dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,OTH,None,None,None,,None,"['Dizziness', 'Heart rate decreased', 'Hyperhidrosis', 'Hypotension']",UNK,MODERNA,IM 930261,IL,27.0,F,"Severe body aches and chills. High grade temperature. Fatigue, extremely tired, joint pain. Symptoms particularly reduced with ibuprofen 600 mg",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,None,None,Asthma,Mild Hives to extremities after first COVID-19 vaccine,No known drug allergies,"['Arthralgia', 'Chills', 'Fatigue', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930262,ME,54.0,F,"I went to bed with a headache 1/5/2021. Woke the next am with a red eye. No drainage, vision loss or pain. I sent photos to my PCP and eye doctor who both said it was conjunctiva hemorrhage. I feel a bit of pressure behind that eye. It is not consistent with conjunctivitis. I have never had this before. .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/06/2021,14.0,PVT,none,none,none,,NKA,"['Conjunctival haemorrhage', 'Headache', 'Ocular hyperaemia']",1,MODERNA,IM 930263,SC,40.0,F,Patient was given Covid Vaccine. She went to the waiting area to sit for the 15 min wait. She then came to the front desk to inform us that her heart rate was elevated and wanted to speak to a nurse. We then notified the nursing staff and took her to a room to be evaluated. After about 15-20 min nursing staff asked front desk to call 911.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,,,,,['Heart rate increased'],1,PFIZER\BIONTECH,IM 930264,NY,29.0,F,"Injection site became warm, swollen, and itchy 8 days after vaccine received. Still experiencing these symptoms 9 days after vaccine received.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,"Levothyroxine, prenatal vitamins",None,None,,"Penicillin, latex","['Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 930265,LA,33.0,F,Rash/hives on face,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,Aderrall Prozac Bystolic,,,,Eggs,"['Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 930266,MI,42.0,F,"Cellulitis, bump and redness by injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,"Hyoscyamine,Lysinopril, Citalopram, Rosuvastatin Junel Fe",,Irritable bowel,,Sulfurs,"['Injection site cellulitis', 'Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 930267,TN,41.0,F,"site swelling, itching along upper extremities, shoulders, and upper back. Itching treated with Benadryl x 2 doses with positive results",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,SEN,"Metformin, Symbicort, Desvenlafaxine, Bupropion, Quetiapine, Alprazolam PRN, Eliquis, Ferrous sulfate, Atenolol, Ventolin inhaler, B12, Zyrtec, Montelukast, Tylenol, Trimcinolone",no,"Polycystic ovarian syndrome, asthma, depression, anxiety, anemia and b12 deficiency, atrial fibrillation, idiosyncratic tachycardia, arthritis, seasonal allergies",,seasonal,"['Injection site swelling', 'Pruritus']",1,PFIZER\BIONTECH,IM 930269,TX,71.0,F,"Treatment with Bactrim DS for 7 days, beginning today. Patient developed rash after inoculation which resolved the following day; then reappeared one week later developed the same itchy, warm rash spreading down her left arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,Carbodopa/Levo tab 25-10 1/2 tab 3xday Trihexyphenidyl 2mg tam 1/2tab 2xday Lisonopril 2.5mg 1tab day Clonazepam .5mg 1 tab at bedtime B12 inj -1xweek fish oil 1000mg 4xday Claritin 5mg 1xday Restasis emu .05% 1 drop both eyes 2xday Senna-P,Parkinson's IBS (October),Parkinson's Hypertension,,Azithromycin,"['Injection site reaction', 'Injection site warmth', 'Rash pruritic']",1,MODERNA,IM 930270,GA,56.0,F,"Redness, itching, swelling at the injection site. The area is getting worst every day after the injection. The worst is on Day 9 (07Jan2021). It is a little better today Day 10 (08Jan2021).",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/29/2020,1.0,PHM,"Nexium, Vitamin D, Biotin, Tumeric , Collagen",None,None,Shingrix,"Cyclosporin, corn, scallops","['Condition aggravated', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 930271,MO,30.0,M,2X POSITIVE CV RAPID TEST. BD AND ABBOTT. CONFIRMED BY PCR,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,01/06/2021,14.0,UNK,BUPROPRION,NONE,NONE,,NONE,"['COVID-19', 'SARS-CoV-2 test positive']",1,MODERNA,IM 930272,IN,42.0,F,"Redness/warmth to arm surrounding injection site; hardness (firmness) surrounding injection site; Fever, muscle aches, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/06/2021,5.0,PVT,Lexapro 10mg Mulitvitamin Biotin,,Crohn's disease,,Ibuprofen Aspirin Latex,"['Headache', 'Injection site erythema', 'Injection site induration', 'Injection site warmth', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 930273,PA,61.0,F,"My lest arm remains swollen and red, slightly itchy at the injection site 11 days after my injection. I also developed a swollen lymph node in the armpit that remains tender and large. I read that this should only last 1-2 days so that is why I am reporting this.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,WRK,"Levothyroxine, Eliquis, Amiodarone, metoprolol, atorvastatin, vit D, multi vit and Zinc",none,"AFIB in NSR, hypothyroidism, small vessel disease, TIA",,Benadryl causes me to be hyper,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 930274,TX,40.0,F,"sore arm, headache, chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"LEVOTHYROXINE 88MCG, VITAMIN C, VITAMIN D, ROBITUSSIN COUGH SUPRESSANT",COVID (SYMPTOMS STARTED 12/21/20),HYPOTHYROIDISM,,PENICILLIN,"['Chills', 'Fatigue', 'Headache', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 930275,NJ,62.0,F,"My initial dose was on a Sunday evening. By Tuesday morning, my right arm was slightly sore and a bit red but gone by the next day. On the 8th day, my right arm was very itchy, large red welt, sore to touch and warm. The welt grew bigger for 3 days and itching and soreness increased. By the 4th day, itching and soreness began to subside. By the 5th day, the redness began to go away. 2nd dose scheduled for 1/24/21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,01/04/2021,8.0,PVT,rosuvastatin amlodipine tylenol,,IBS high triglycerides diverticulitis sinus,,"morphine, codeine, contrast, sulfa, cephalosporis, levofloxcin, metronidazole certain fruits, lamb, raw tomatoes","['Erythema', 'Pain in extremity', 'Pruritus', 'Skin warm', 'Tenderness', 'Urticaria']",1,MODERNA,SYR 930277,CA,50.0,M,"patient described feeling lightheaded, near syncope, 'almost passed out' 15 minutes after vaccine administration",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,none,none,none,,none,"['Dizziness', 'Presyncope']",1,MODERNA,IM 930278,AL,14.0,F,"Patient is 14 years old, and the vaccine is not indicated for patients under the age of 18. We have been checking in with the patient and the patient has not experienced any signs or symptoms of any adverse event.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,PVT,"Lamictal, Keppra, folic acid",none,epilepsy,,none,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 930279,CA,44.0,F,"On 1/7/21, at approx 1:05 PM, Maria noticed she was feeling very sleepy. Her co-workers noticed her left arm had bluish color, cold temp, and she had some tingling in her arm. Her blood pressure was elevated at 160/100. Patient was evaluated by Dr. and she recommended patient follow up in the ED. Patient was taken to ED by her Director. She states that ED staff told her this was a common reaction and that they would observe her for a couple hours. Her blood pressure decreased to less than 140/90. She states she was feeling better and returned to work at 4:40 PM to finish her shift.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Patient denies taking any OTC or prescribed medications.,Patient denies having any illness in the month preceding the injection.,None,,Patient denies any food or medication allergies.,"['Blood pressure increased', 'Cyanosis', 'Feeling cold', 'Paraesthesia', 'Somnolence']",1,MODERNA,IM 930280,PA,50.0,F,"Nausea, child, feeling unwell. NO fever",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/08/2021,2.0,PVT,Duloxitine 60 mg,,,,,"['Chills', 'Malaise', 'Nausea']",UNK,PFIZER\BIONTECH, 930281,OH,34.0,F,"12 hours post vaccine - pain and redness and injection site. Continued for 2 days then fully resolved. 7 days post vaccine- large red, hard welt that itches significantly. Cortisone cream minimally effective.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/07/2021,7.0,PVT,,None,,,None,"['Injection site erythema', 'Injection site pain', 'Pruritus', 'Urticaria']",1,MODERNA,IM 930282,WV,64.0,F,Rash noted several days after vaccination. Rash noted to occur to hands and upper chest. Benadryl taken to help control the rash with some effectiveness. Rash on chest has resolved now. Rash on hands noted to persist. Once Benadryl wears off the rash comes back. This has occured for 3 days in a row.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/05/2021,13.0,PVT,methylphenidate HCL Ocrevus solifenacin trimcinolone acetonide,None,,,None noted,['Rash'],1,MODERNA,IM 930283,FL,52.0,F,"Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Skin is sore from the fever. Headache, temp 100.3. Weak and loopy, slept all day. Hurts under the arm. SOB.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,"Valsartan, Albuterol, Zyrtec",no,"asthma, allergies, high bp.",,"To the environment, Shrimp, lamb, sweet potato, tree nuts, tea.","['Asthenia', 'Axillary pain', 'Chills', 'Cold sweat', 'Dyspnoea', 'Feeling abnormal', 'Feeling hot', 'Headache', 'Nasopharyngitis', 'Pain in extremity', 'Pain of skin', 'Pyrexia', 'Swelling']",2,PFIZER\BIONTECH,SYR 930284,CT,42.0,F,Headache lasted for a week..,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,Zoloft Daily,None,None,,TreeNut,"['Headache', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,SYR 930285,AZ,52.0,F,"HA,chills,muscle,joint pain,nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,WRK,Lisinopril 20mg Zyrtec Omprazole 20mg Multi vitamin,On December 20 I tested positive for the COVID virus but today?s symptoms are much much worse,"Asthma, HTN",,No,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Nausea']",7+,MODERNA,IM 930286,NM,42.0,F,"1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and aspirin. 1100 to 01/07/2021, 0200 severe lethargy lasting till around this time. Heart rate excess of 130, dizziness, severe weakness, muscle pain, fever 103 to 104 F. 650mg oral Tylenol and aspirin 325mg every 6 hours does not control temp. Intermittent periods of extreme perspiration. 0200 1/07/2021 to 1200, slow decline in body pain with ongoing Tylenol and aspirin every 6 hours. No more elevated temps. Injection site/arm remains painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"Levothyroxine, multivitamin, allegra",None,"Hashimotos, sjorgens",,None,"['Asthenia', 'Body temperature increased', 'Chills', 'Heart rate increased', 'Hyperhidrosis', 'Injection site pain', 'Lethargy', 'Pain']",2,PFIZER\BIONTECH,IM 930287,UT,34.0,F,Called immunization line and left message. Called client back. Complaining of generally not feeling well; extremely dizzy; HA; nausea; vomiting; diarrhea on 1-8-2021,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,UNKNOWN,UNKNOWN,UNKNOWN,,UNKNOWN,"['Diarrhoea', 'Dizziness', 'Headache', 'Malaise', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 930288,MT,58.0,F,"Bad headache, dizzy, very tired, nausea, blurred vision.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,SEN,"Losatan 100mg, Losartan HCTZ 12.5 mg, Amlodipine 10mg, Vitamin Code raw one vitamin for women",none,"HBP, obesity",influenza vaccine,Penicillian,"['Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Vision blurred']",UNK,PFIZER\BIONTECH, 930289,TX,23.0,M,"At 2:00am 12/19/20 I woke up to an episode of diarrhea and was left feeling nauseous. I woke up again at 4:30am with another episode of diarrhea and severe nausea which led me to throw up. I feel better after throwing up and proceeded to get rest before going to work at 6:00am. By 8:00am I had developed a severe headache, severe nausea, muscle fatigue and overall felt bad. When I got home I had become extremely nauseous and developed severe muscle fatigue and severe arthralgia and my headache had increased and became sweaty and dizzy. I slept from 9:00am to 2:00pm where the symptoms had gotten no better and the headache had gotten worse. I slept from 3:00pm to around 6:00pm with the same symptoms but managed to eat some soup and kept it down. I slept from 10pm to 12pm the next day 12/10/20. My fatigue and joint pain had somewhat dissipated but I was still experiencing severe nausea and a severe headache. By the end of 12/10/20 around 8pm my joint pain and muscle fatigue had gotten better but the nausea and headache were still there. 12/11/20 I was well enough to drive and receive a covid test. My nausea and headache did not go away until the end of day 12/11/20",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,None,None,None,,Sulfa drugs,"['Arthralgia', 'COVID-19', 'Diarrhoea', 'Dizziness', 'Feeling abnormal', 'Headache', 'Hyperhidrosis', 'Muscle fatigue', 'Nausea', 'SARS-CoV-2 test negative', 'Vomiting']",1,PFIZER\BIONTECH,SYR 930290,PR,51.0,F,"On January 5,2021, developed chills, muscle ache, headache, joint pain ,fever and left arm pain. Taken Acetaminophen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,Albuterol inhaler pump as necessary Acetaminophen 650 mg 2 tabs every 8 hours,NO,Bronchial Asthma,,ASA,"['Arthralgia', 'Chills', 'Headache', 'Injection site pain', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930291,IL,61.0,F,"3 INCH induration and moderate erythema, tender to the touch, causing local muscle ache and joint pain, and fatigue Used Voltaren (diclofenac) topical gel two times per day for 5 days, Tylenol PM before bed",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,PVT,"Vitamin D, Vitamin B12, Fish oil",none,hypertension,,Cipro,"['Arthralgia', 'Erythema', 'Fatigue', 'Induration', 'Local reaction', 'Myalgia', 'Tenderness']",1,MODERNA,IM 930293,WY,49.0,F,my hands are tingling,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,none,none,none,,none,['Paraesthesia'],1,MODERNA,SYR 930294,CO,46.0,M,"dizziness, not feeling well, felt better laying down, had headache which worsened upon sitting. Generalized rigors, has had in the past after and epidural. 96/64, HR 72, SPo2 99%. Taken to ED at 9:15 am. Given Ativan and observed for 4 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Undergoing Chemotherapy,,Cancer,,unknown,"['Chills', 'Dizziness', 'Headache', 'Malaise']",1,MODERNA,IM 930295,NY,51.0,F,"Left axillary lymph node enlargement - began day 2 after vaccination (1/1/21) and continues as of today 1/8/21. Left neck lymph node enlargement and sore throat began 1/6/21, pustule in left throat 1/7/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,Vitamin D supplements,none,none,,Penicllin,"['Lymphadenopathy', 'Oral pustule', 'Oropharyngeal pain', 'SARS-CoV-2 test']",1,MODERNA,IM 930296,CO,94.0,M,"Days 1-3 - fatigue, lightheadedness, shoulder pain. Day 7: redness, mild swelling, mild tenderness at injection site (no infection)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,"Amlodipine, allopurinol, casodex, monopril vitamin D",prostate cancer,"HTN, CKD, glaucoma, OA","Delayed immune response to horse antitoxin, years ago",Horse antitoxin (tetanus) - delayed vaccine reaction,"['Arthralgia', 'Dizziness', 'Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA, 930297,RI,29.0,F,"29-year-old previously healthy female presenting today with difficulty sleeping, sore throat, and nausea after receiving the second Pfizer COVID-19 vaccine around 10 AM. Patient says that after her first dose of the vaccine she had mild sore throat and hoarse voice that resolved spontaneously. She had her vaccine around 10, several hours later before coming to the emergency department between 2--230 she had the sudden onset of difficulty speaking with associated sore throat and nausea. She has had dry heaving but no large amounts of vomiting. She has not had stridor, wheezing, shortness of breath, syncope, or the development of a rash or hives. She has not had a reaction to her prior vaccines she does not have any other allergies in general. She has otherwise been well recently without infectious symptoms including fevers, chills, cough, and has not been exposed to Covid to her knowledge. Medications administered in ED included diphenhydramine 50 mg IV once, dexamethasone 10 mg IV once, famotidine 40 mg IV once, ondansetron 4 mg IV once. Had brief episode of shaking and R arm rigidity in the ED. Patient denies LOC during the episode, did not have a post ictal state, no tongue biting or episodes of incontinence. Given single event without LOC, less concern about episode being a seizure. Patient has had no further episodes of shaking since admission. CT brain was wnl, no FNDs noted on exam.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Adderall,,ADHD,,Adhesive tape (NOT allergic to latex),"['Blood creatine phosphokinase normal', 'Blood lactic acid', 'Computerised tomogram head normal', 'Dysphonia', 'Insomnia', 'Muscle rigidity', 'Nausea', 'Oropharyngeal pain', 'Retching', 'Speech disorder', 'Tremor', 'Vomiting']",2,PFIZER\BIONTECH,IM 930298,SD,62.0,F,2 days of fever and muscle aches with fatigue. 11 days of bicep pain radiating down to elbow and into armpit of left arm. Unable to use arm except for limited activity.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,Levothyroxin Escataloprin,Cold with sinus issues,None,,"Latex, bananas","['Axillary pain', 'Fatigue', 'Myalgia', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 930299,CA,62.0,F,"Tachycardia (HR in the 110s), felt warm, forearms visibly flushed, nausea 20 min post vax Observation and fluids Sxs resolved after 15 mins of close monitoring NKA",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,,,,,,"['Feeling hot', 'Flushing', 'Nausea', 'Tachycardia']",1,PFIZER\BIONTECH,IM 930300,NY,52.0,F,"Pain, heaviness, swelling, redness, itching, extreme induration and tenderness at injection site; severe headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,None,None,None,,None,"['Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Limb discomfort']",1,MODERNA,IM 930302,MO,,U,Cough shortness of breath r/t asthma,Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,OTH,,,,,,"['Asthma', 'Cough', 'Dyspnoea']",2,PFIZER\BIONTECH,IM 930303,NY,28.0,F,"First experienced arm pain at site of injection, chills and body aches within 13 hours of the 2nd COVID-19 Pfizer vaccine. 27 hours following administration of the vaccine in addition to body aches and chills, I then experienced headaches, fever of 101.8, and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Vyvanse 40 mg PO daily, Beyaz Birth Control 1 tablet PO daily",None,None,,NKA/NKDA,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930304,IL,50.0,F,Patient experienced swelling of the throat and numbness in the neck within 10-15 minutes of vaccine administration while still under observation. Two oral Benadryl tablets were given (50mg total) and epipen was administered in the left thigh. 911 was immediately called and patient was taken away in ambulance,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,SEN,Unknown,No,Hypothyroid,,Aspirin,"['Pharyngeal hypoaesthesia', 'Pharyngeal swelling']",1,PFIZER\BIONTECH,IM 930307,MD,41.0,F,"Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nurse and at that time my watch was beeping afib.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,,,WRK,"Ibasarin 300mg, zyertec 40mg, benadryl 50mg, pepcid Ac,",,"Pots, MCAS, SFN",,N/a,"['Atrial fibrillation', 'Electrocardiogram normal', 'Feeling hot', 'Laboratory test normal', 'Rash', 'Rash erythematous', 'Tachycardia']",1,PFIZER\BIONTECH,IM 930308,TX,24.0,F,"Redness, swelling and itching at injesction site of right deltoid",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PUB,None,None,None,,Bananas and avacodos,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 930310,TX,37.0,F,"Swelling, give, redness, pain, and hot to the touch",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/07/2021,8.0,PVT,"Metformin, montelukast",,Allergy induced asthma,,Triptans,"['Erythema', 'Pain', 'Skin warm', 'Swelling']",1,MODERNA,SYR 930311,CA,61.0,F,"Tachycardia (HR in the 110s), substernal chest pressure, dizziness 15 min post vax Observation and fluids Sxs resolved after 30 mins of close monitoring NKA",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,,,,,,"['Chest discomfort', 'Dizziness', 'Tachycardia']",1,PFIZER\BIONTECH,IM 930312,IN,38.0,F,"Chills, nausea, muscle aches, joint aches, fatigue, feve 102.0 Taking Tylenol, ibuprofen, promethazine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Trazodone, elevil, requip, Prozac, wellbutrin, promethazine, Maxalt, aimovig","Clinically diagnosed covid19 December 12th, 2021","Migraine, depression",,"Skelaxin, Nifedipine","['Arthralgia', 'Chills', 'Fatigue', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,IM 930314,NM,45.0,F,"Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection. Rapid Response called @1721, patient monitored.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Neck pain', 'Pain', 'Pain in extremity', 'Pain in jaw']",1,PFIZER\BIONTECH,IM 930315,CA,33.0,F,"With in 10 mins of receiving 1st dose, I started to feel hot and light headed, my body became very hot, I started to sweat and then my throat started to dry up and close. I notified the provider on watch that was monitoring me during my 15 mins after injection and as the walked me to the room I became more and more dizzy, my throat continued to swell and close, my mask was removed where my face was covered with a rash and hives . The dr. Gave me 50 mg benedryl, and a shot of epinephrine. After wards 911 was called, my heart rate was eventually brought down with the epinephrine as my symptoms began to be controlled. An inhaler was administered because I was short of breath. 3 hours later I was stabilized. I then was recommended to go to urgent care rather the emergency room since the wait was 13 hours to be monitored at the local hospital MLK. I went to urgent care near my home at Hoag hospital and they monitored me and gave me a steroid injection IM. I was discharged with an epi pen just in case abs to take benedryl every 6 hours . The following morning 1/8/21, at 8 am the swelling of my throat retuned I became light headed abs my tongue became numb. I was taken to fountain valley hospital where an IV was started, 500 mg of iv benedryl, another epinephrine injection was given abs I remained under surveillance for another 6 hours. They stated that a lot of people are coming with reoccurring episodes of anaphylaxis after the phizer injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,"Multivitamin , biotin,",None,None,,Pcn-hives,"['Blood calcium normal', 'Blood chloride normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea nitrogen/creatinine ratio', 'Blood urea normal', 'Dizziness', 'Dry throat', 'Dyspnoea', 'Feeling hot', 'Glomerular filtration rate normal', 'Haematocrit normal', 'Haemoglobin normal', 'Heart rate increased', 'Hyperhidrosis', 'Hypoaesthesia oral', 'Pharyngeal swelling', 'Platelet count increased', 'Rash', 'Red blood cell count normal', 'Shift to the left', 'Throat tightness', 'Urticaria', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 930316,MD,86.0,F,"Patient is an 86 year old dementia non-verbal patient at the Stadium Place Nursing and Rehabilitation center. She is generally not alert and has a lot of grunting and arm tremors. On January 8, 2021, she received the Pfizer Covid-19 vaccination on her right arm. About an hour later, the patient?s aid reports patient having a minor nosebleed. The nursing home facility staff noted that patient does not normally exhibit such symptoms. Of note, Pt is on 4 liters of oxygen around the clock and has a nasal cannula inserted in her nostrils. Nursing staff believes this nosebleed is possibly related to the covid 19 vaccine. In addition, nursing staff also attempted to take patient blood pressure but due to constant movements and tremors the reading could not be done. She was monitored for next few hours and no other symptoms has presented.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,SEN,,,,,,['Epistaxis'],1,PFIZER\BIONTECH,IM 930317,AR,38.0,F,"Patient reports developing around the injection site, radiating to hand. Says arm was warm to the touch with mild swelling. Also reports nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PHM,,None,Patient reports COVID infection back in june 2020,,none,"['Nausea', 'Skin warm', 'Swelling']",1,MODERNA,IM 930318,AZ,49.0,M,"Gave patient vaccine administration, after 20 minutes of monitoring patient stood up to leave and felt dizzy and light headed. He turned pale as well. I quickly had him sit down and called the provider in. We listened to heart and lungs, obtained vitals which were: P: 57 BP: 130/65 Temp: 97.5 SP02: 100% Continued to monitor, provider got a more advanced medical history from patient and provider felt like patient was stable enough to monitor for 20 more minutes with no interventions and leave. Patient is discharged",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,"Type 2 diabetes, end stage renal disease on dialysis, hyptertension","type 2 diabetes, ESRD",,None,"['Dizziness', 'Pallor']",1,MODERNA,IM 930319,TX,38.0,F,Sore arm for 3-4 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,"Fish oil, prenatal vitamins",Headache,Back pain,,None,['Pain in extremity'],1,MODERNA,SYR 930321,KY,33.0,F,"On 1/7/21 I noticed a slightly enlarged left supraclavicular lymph node. There was a small amount of edema in the area surrounding it. I applied heat to it and this seemed to relieve some of the swelling. Around noon on 1/8/21 the lymph node and the tissue sounding it had approximately doubled in size from the night before. I went to my local urgent care center. The doctor seemed to think that there is a very high probability that it is my body reacting to the vaccine, especially since I still currently have a visible bruise on my arm from the injection. The injection was on the same side as the swelling. She couldn't confirm that it is a reaction with 100% certainty, I was prescribed Keflex 500mg tabs TID for a week just in case there is an infection present. I am supposed to monitor the size of the swelling and follow up with a PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/07/2021,15.0,PUB,None,None,None,,NKA,"['Injection site bruising', 'Lymphadenopathy', 'Oedema']",1,MODERNA,IM 930322,WA,59.0,F,"Received dose #1 of Moderna on 12/31/2020 Day #1 - nothing Day #2-3 - mild tenderness at injection site Day # 8 - Left arm induration 6cm X 7cm i Around injection site: red, hot, tender with itching. Small central pustule at injection site surrounded by induration- pustule then resolved . Accompanied by headache & sore throat. Benadryl did not resolve left arm symptoms Tylenol helped headache Did not need to use Epi pen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,PVT,Benadryl Tylenol,None,Asthma,,"Shellfish, Bee Stings , carrots","['Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site pustule', 'Injection site warmth', 'Oropharyngeal pain']",1,MODERNA,IM 930323,CA,50.0,F,"Tachycardia (HR in the 110s), shortness of breath, chest pain 15 min post vax Observation and fluids Sxs resolved after 15 mins of close monitoring NKA",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,,,,,,"['Chest pain', 'Dyspnoea', 'Tachycardia']",1,PFIZER\BIONTECH,IM 930324,CT,58.0,F,"Pt had just been sent to observation area from vax station and reported that she was feeling ""very warm"" and that she was experiencing some ""heart palpitations"". I was called over to assess her. She was flushed in the face, BP was 134/80 with pulse of 80, regular. She denied shortness of breath or chest discomfort. She was wearing a warm sweater and hat, so we removed the hat and transferred her by wheelchair to a cooler area. She was still feeling weak, so we initiated a 911 call for EMS evaluation. EMS arrived on site within 4 minutes and performed evaluation. Pt was less flushed and stated she felt much better. She was not transported. Left clinic with her husband. I called her today to follow up. Other than some site tenderness and feeling ""a little light headed"" this morning, she feels fine. She stated that she took ibuprofen for the injection site tenderness. Her entire episode at the clinic last about 12-14 minutes from onset to time she left with her husband.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,"Levothyroxine, Fish Oil, Multivitamin, A-Red 2, minocycline, ASA 81 mg",None,"Hypothyroidism, Rosacea, ?autoimmune disorder, states her doctor told her that her RBCs were too small for iron to bind to which contributed to her anemia (I asked why she was getting the iron infusion)",,Severe reaction to a 10 minute iron infusion just over 4 years ago. Unsure of name.,"['Asthenia', 'Dizziness', 'Flushing', 'Injection site pain', 'Palpitations', 'Skin warm']",1,MODERNA,SYR 930326,LA,46.0,F,"Low grade fever, severe exhaustion x 8 days, muscle aches, joint pain. Low grade temp only lasted a few days, but aches, pain and exhaustion continues on day 9. I did have my antibodies checked in November and i still had positive antibodies from having Covid in July.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,WRK,none,none,none,,none,"['Arthralgia', 'Fatigue', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 930328,TX,41.0,F,anaphylaxis with immediate whole body swelling. Epinephrine 0.3mg IM administered,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Anaphylactic reaction', 'Immediate post-injection reaction', 'Swelling']",2,PFIZER\BIONTECH,IM 930330,TX,71.0,F,"Had covid in October. Felt like she did when she had covid. Painful joints, gross fatigue, no appetite, sore arm, low grade temp. No energy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Folic acid, Naproxen, levothyroxine, Prilosec, methotrexate, REMICADE infusion. Wellbutrin, Lomax.",no,"RA, Thyroid cancer survivor.",,Most narcotics,"['Arthralgia', 'Decreased appetite', 'Fatigue', 'Pain in extremity']",1,MODERNA,SYR 930331,CA,59.0,F,"Tingling around mouth 6-7 min post vax Observation and fluids Sxs resolved after 5 mins of close monitoring Allergies: Codeine, Latex, Iodine Contrast, Hydrochlorothiazide. No known food allergies, but consumed two foods new to her (yogurt parfait and Gatorade Zero) just prior to injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,,,,,,['Paraesthesia oral'],1,PFIZER\BIONTECH,IM 930332,TX,51.0,F,Rash to the upper arm a week after vaccination. A wheal of about 8in x 4in around the site of injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2000,01/07/2021,7312.0,PVT,None,None,None,,None,"['Injection site urticaria', 'Rash']",1,MODERNA,IM 930333,CA,36.0,F,"Felt I warm sensation through my whole body, got light headed and could feel my heart beating strong.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,UNK,"Elderberry, emergenc gummed, melatonin.",None,None,,None,"['Dizziness', 'Feeling hot', 'Palpitations']",UNK,MODERNA, 930334,NC,21.0,F,"Extremely sore arm, muscle twitching, strange nerve sensations since after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/27/2020,1.0,PVT,"Bromocriptine, Levothyroxine, Vitamin D",None,Pituitary Adenoma Hypothyroidism,,None,"['Feeling abnormal', 'Muscle twitching', 'Pain in extremity']",2,MODERNA,IM 930335,TX,59.0,F,Swelling and pain of knees. Ankles. Fingers. Toes. SOB. Extreme fatigue.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Levothyroxin Asa 81mg Estrogen 1mg Spironolactone 50mg,,,,Naproxen Anaprox Macrobid Sulfa Statins,"['Arthralgia', 'Dyspnoea', 'Fatigue', 'Joint swelling', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 930336,OH,53.0,F,Generalized arm soreness turned into severe right arm/shoulder pain with limited arm movement. Prescription provided for Medrol pack (steroids) dues to severed arm/shoulder inflammation.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,OTH,Synthroid 112 mcg PO daily,none,hypothyroidism Seasonal allergies,,"minocycline Allergy= Sever itching Seasonal allergies,: hay fever, dust mites, mold, rag weed, golden rod, grass","['Injected limb mobility decreased', 'Injection site inflammation', 'Injection site pain', 'Pain in extremity']",UNK,MODERNA,IM 930337,NM,26.0,M,I woke up around 3 am because of body aches. The body aches worsened and i checked and had a fever of 100.6 degrees Fahrenheit. My head started to pound and my pulse was accelerated to probably 80 bpm (normally rest at 60 bpm). I felt a little lightheaded and a bit nauseas. I took 2 200 mg tablets of EC ibuprofen and did not take Tylenol because i knew my immune response needed to take its course. it is about 3:33 in the afternoon and my body is still aching but my fever has dissipated and I still have a headache that throbs when I walk.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,SEN,none,none,none,,phenobarbitol,"['Dizziness', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 930338,KY,33.0,F,"Checked on patient frequently. Patient talking and using her phone 0930, 0935, 0945. Checked on patient again at 0950. She reported a bad headache. Patient reported feeling uneasy at 0955. Called for Medical Response Team. 0956 patient shaky but talking. 0957 patient hooked up to heart monitor. 1004 taken to Emergency Department.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,Citalopram 20 mg orally daily Lisdexamfetamine 30 mg orally daily Trazodone 50 mg orally every day at bedtime,Depression Dysmenorrhea Menometrorrhagia Menorrhagia,None reported,,Nubain,"['Anxiety', 'Blood glucose normal', 'Cardiac monitoring', 'Headache', 'Tremor']",1,MODERNA,IM 930339,MO,70.0,F,"Had my 2nd vaccine on Jan 7, 2021. My arm was sore when I went to bed that night. I woke at 5:15 AM feeling achy. I took my temp and it was 98.8F which is a temp for me since I run low, around 96.9F I got ready for work at the hospital and went in. around 0830 my temp was 99.5 and I was more achy and sore. I called Employee Health and they said to continue to monitor my temp and call back if it passes 100. Then around 3PM , my temp was 101.5F I remain very achy and have some occasional ear pain and a mild headache,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"NP Thyroid, Low dose Naltrexone, Melatonin, Vit C, D, E, omega 3, Bone Restore,",No illness but I did had a gum graft at the dentist 2 days before my second dose.,Hashimotos thyroiditis,,None,"['Body temperature increased', 'Ear pain', 'Headache', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 930340,TX,41.0,F,"Upon receipt of vaccine: pain/redness/swelling at injection site and headache (expected and resolved by 12/31/2020); then on 1/7/2021, redness returned with swelling consistent with hives, accompanied by intense, prolonged itching at the injection site. Swelling and redness persists.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PUB,"Kirkland Aller-Tec, Multivitamin, Vitamin D",None,"Essential Thrombocytosis, Von Willebrand Disease",,"Sulfa, unidentified type of fish","['Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria']",1,MODERNA,IM 930341,IL,31.0,F,"Heart palpitations, tachycardia, PVCs and shortness of breath, fatigue, weakness started on Monday (1/4), worsened over next 2 days. Saw primary doctor on 1/7 who called paramedics to take me to the ER due to EKG results and increased work of breathing. ER doctor suspects mild guillain-barre reaction, I will be following up with cardiology and pulmonology as soon as possible as they were unable to determine exact cause or fix the issues.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,01/04/2021,18.0,PVT,"Pantoprazole, Klonopin, Wellbutrin, Humira",none,"Ankylosing Spondylitis, Asthma, GERD, peptic ulcer disease, chronic gastritis, anxiety and depression",,none,"['Asthenia', 'Blood thyroid stimulating hormone', 'Chest X-ray', 'Computerised tomogram thorax', 'Dyspnoea', 'Electrocardiogram', 'Fatigue', 'Fibrin D dimer', 'Full blood count', 'Guillain-Barre syndrome', 'Metabolic function test', 'Palpitations', 'Tachycardia', 'Ventricular extrasystoles']",UNK,PFIZER\BIONTECH,IM 930342,OK,61.0,F,"Started with headache earlier in day, then arm pain at injection site by 530 pm , then my whole body hurt around the same time, 530 pm., about 130 am I woke up with chills and vomiting. Vomiting was short time, but aches and arm pain remained throughout next day. The body aches stopped by 1/6 am and the arm pain was mostly gone by 1/7. No treatment required.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Vit D, Zyrtec, Tagamet, naproxyn, Norco 7.5;",none,Neck and back pain and sciatica,"flu shot, just some injection site pain for a day or two","Penicillin, adhesive","['Chills', 'Headache', 'Injection site pain', 'Pain', 'Vomiting']",1,MODERNA,IM 930343,MA,49.0,F,delayed large hive at arm 8 days after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,PVT,,none,"thyroid nodules, vitamin d deficiency, atypical ductal hyperplasia of the breast",,Tegaderm,['Urticaria'],1,MODERNA,IM 930344,,27.0,F,"10:51 metallic taste in mouth 10:58 tongue numbness, not able to feel tongue and on roof of mouth 11:08 hr 100-113 resp 20 bp 124/72 11:10 progressibly more difficulty when swallowing, lungs cta, individual was anxious 11:12 transferred to ED via wheelchair",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2020,01/08/2020,0.0,UNK,,,,,,"['Anxiety', 'Dysgeusia', 'Dysphagia', 'Hypoaesthesia oral']",2,PFIZER\BIONTECH,IM 930345,CA,53.0,F,"Headache and lightheadedness 15 min post vax Observation, fluids, food Sxs resolved after 10 mins of close monitoring NKA",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Dizziness', 'Headache']",1,PFIZER\BIONTECH,IM 930346,WA,43.0,M,"Member received vaccine at clinic around 1002. He then returned to work at clinic. He reports he started feeling dizzy and nauseated around 1200. A medical emergency was called around 1215. Symptoms progressed to flushing, red raised rash and seeing spots. Member was given epi 0.3 mg IM and Benadryl 50mg IM with resolution of symptoms. Member was observed for 1 hour then discharged to home with a follow up phone visit 1/8/21 PM. He was advised to continue taking Benadryl 50 mg PO every 6 hours x 24 hours and was given an epi pen to use in case emergent symptoms returned.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Dizziness', 'Flushing', 'Nausea', 'Rash erythematous', 'Rash papular', 'Visual impairment']",1,MODERNA,IM 930347,NY,24.0,M,"Severe chills, uncontrollable shivering, severe headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,Bupropion,None,None,,None,"['Chills', 'Headache']",1,MODERNA,IM 930348,NJ,33.0,F,"I am breastfeeding. My daughter had seizure like episodes starting on Saturday 1/2, Sunday 1/3, Monday, 1/4 and 2 times on Tuesday 1/5.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,12/28/2020,01/01/2021,4.0,SEN,"Prenatal, sunflower lecithin",No,Pcos,,Tree nuts and shellfish,['Maternal exposure during breast feeding'],1,PFIZER\BIONTECH,SYR 930349,OK,34.0,F,"Severe pain, tenderness and swelling in L axillary, Ibuprofen, Tylenol and warm compress to site effected",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,Levothyroxine 75mcg Vitamin C Vitamin D Vitamin B12 Zinc Pre natal vitamin Fish oil Chlorthalizone Metoprolol Ibuprofen Hydroxizine Tylenol PM,NONE,Hypothyroidism High Cholesterol High blood pressure,,Yellow Jackets,"['Fatigue', 'Lymphadenopathy', 'Pain', 'Ultrasound scan']",2,PFIZER\BIONTECH,IM 930350,CA,40.0,M,"6 hours after injection, swelling around inject site, pain of deltoid. Next day: Mild chills, slight nausea, malaise, mild headache at 32 hours after injection, lasting 2 hours till went to bed. Woke up next morning tired, mild headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,UNK,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Malaise', 'Nausea']",UNK,MODERNA, 930352,KS,38.0,M,"Progress Notes (Physician Assistant) ? ? Family Medicine Cosign Needed Expand All Collapse All 1/8/2021 � Date: 1/8/2021 � Subjective Patient is a 38 y.o. male who was seen at COVID Vaccine Clinic today for his second dose of the COVID 19 vaccination. He denied any history of previous adverse reactions to other vaccines, but does note he had tingling to the right side of his face after his first dose that lasted 3 days. � He was given the Pfizer vaccination in the right deltoid muscle.During his 15 minute waiting period after the injection, the patient began to experience tingling to right side of face. He denied difficulty breathing, throat tightness, itching, lightheadedness and facial swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms. � ALLERGY REVIEW OF SYSTEMS: Patient denies chest tightness, shortness of breath, wheezing, rash and dizziness +right sided facial tingling.: � Previous Reactions: Patient states he had right sided facial tingling after receiving his first vaccination, but was not evaluated in the medical bay. He states the numbness and tingling lasted approx. 3 days. Denied weakness in right sided facial muscles at that time. � Objective � Vitals Vitals: � 01/08/21 1318 01/08/21 1337 01/08/21 1342 BP: (!) 153/101 137/88 125/85 Pulse: 69 71 60 SpO2: 98% 99% 98% � Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. � � Assessment/Plan Treatment included: antihistamines and Tylenol 1000mg. Tylenol was given by patients wife at 1331. Follow up response to treatment: Patient continues to have tingling to right side of his face. His respirations have decreased however and he is feeling better. BP and HR have improved throughout visit. Patient discharge: Stable to go home and follow up with PCP. Discussed returning to work for the remainder of the day. � Instructed to F/U in ER if symptoms worsen. � Electronically Signed 1/8/2021 1:44 PM � �",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,"['Blood pressure increased', 'Paraesthesia']",UNK,PFIZER\BIONTECH,IM 930353,MN,16.0,F,"Patient in clinic for chief complaint of possible side effect of the covid vaccine which she received yesterday. She states that she woke up at 0200 with chest tightness, achyness and headache. She rates the discomfort 7/10 last night and improved now to 5/10. She denies any worsening with any type of exertion and states that she can do simple things like take a shower, walk across the room, down the street or even stairs without any worsening. She denies any SOB or chest pain--just feels tight. Doesn't feel like she can't get a full breath or get the air out of her lungs either. She received her first of two doses of the Pfizer vaccine yesterday (4:23pm) and had no difficulty with the injection itself and then 9.5 hours later woke up from sleep with this chest tightness as well as achyness and headache. �She states that she had the exact same symptoms when she had positive covid test back in August of this year with the addition of fatigue which lasted for 5 days. At that time it was not felt necessary to do any further testing nor treat with steroids according to cardiology. She does have history of LV non-compaction cardiomyopathy and her last visit with cardiology was about 2 years ago and she had a normal EKG and echo only showed ""mild LV non compaction at the apex"" at that time. He did not need to see her again until she is 18 unless she has problems. She states that she generally does very well and other than this tightness she does not have any other significant symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,None,None,Cardiac murmur LV non-compaction cardiomyopathy,,Penicillin,"['Chest discomfort', 'Discomfort', 'Dyspnoea', 'Headache', 'Pain']",1,PFIZER\BIONTECH,IM 930354,TX,41.0,F,"Redness,swelling, tenderness, bruising, cellulitis, warmth, itching at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/01/2021,9.0,PVT,"zoloft, vraylar",none,Asthma,,Sulfa,"['Injection site bruising', 'Injection site cellulitis', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 930355,TX,72.0,M,"Pain in joints, pain in back and shoulder, fever101+. Gross fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"lisinopril 20mg, Rosuvastatin, flexeral",no,no,,no,"['Arthralgia', 'Back pain', 'Fatigue', 'Pyrexia']",1,MODERNA,SYR 930357,,24.0,F,Sore arm for 24 hours and headache on and off for 12 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Headache', 'Pain in extremity']",UNK,MODERNA, 930358,NY,40.0,F,"low-level headache (was able to go to work, but a bit miserable), tired/run down-lasted several hours (no more than 10) arm pain (at injection site)-it is a bit warm to the touch and a small bruise- still occuring (approximately 12 hours after it started this morning)",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,UNK,multi-vitamins with iron iron supplement elderberry plus supplement vitamin B,,,"flu shot-several years ago. Similar to what I am experiencing now with the COVID shot (arm pain and ok to do things, but somewha",raw parsnips many household cleaning products,"['Fatigue', 'Feeling abnormal', 'Headache', 'Injection site bruising', 'Injection site warmth', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 930359,IN,52.0,M,"Extreme Chills, Very Cold, Terriable Headache, Low Grade Fever, Very Weak, Upset Stomach. Felt like I had a bad case of the flu. I had to stay home from work 1/7/21 and 1/8/21 Most of the effects are gone but I still do not feel good but alot better than before. Its 2 Days after the shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,Testosterone CYP 200 MG/ML OIL Lisinopril 20 MG Tablet Multi Vitamin Vitamin C Melatonion Glucosamine,None,High Blood Pressure,,None,"['Abdominal discomfort', 'Asthenia', 'Chills', 'Feeling cold', 'Headache', 'Impaired work ability', 'Influenza like illness', 'Malaise', 'Pyrexia']",UNK,MODERNA,IM 930360,CO,45.0,U,Severe bloody nose that would not stop bleeding. 911 called and came to office. 911 used medication to stop the bleeding but could not. Went to ER and a balloon rocket was placed in nose after several hours of trying to get the bleeding under control.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/06/2021,4.0,UNK,,,,,,"['Epistaxis', 'Nasal cavity packing']",UNK,MODERNA, 930361,NC,30.0,F,"APROXIMATELY 25 MIN AFTER RECEIVING VACCINE DOSE C/O FEELING LIGHTHEADED, SOB,C/O FEELING WHEEZY, HAD NON PRODUCTIVE COUGH. VS 121/71, HR 66, RR24, O2 SAT 100% ON RM AIR. STATED SHE HAD SIMILAR SYMPTOMS A FEW YEARS AGO AFTER RECEIVING FLU SHOT WITH PRESERVATIVE BUT HAD FLU SHOT PAST FEW YEARS WITH NO PROBLEM,PATIENT WAS TAKEN TO ED AT MSMHC",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,"EPINEPHRINE PEN PRESCRIBED, ASTHMA INHALER",,,FLU SHOT A FEW YEARS AGO SIMILAR REACTION,SHELLFISH,"['Condition aggravated', 'Cough', 'Dizziness', 'Dyspnoea', 'Wheezing']",1,MODERNA,IM 930362,MT,67.0,M,On 12/25/2021 I started developing Covid symptoms & on 12/26/2021 I tested positive for covid. Just had a video chat with doctor and he recommended a covid test.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/25/2020,8.0,PVT,Vitamins doxazosin Tamsulosin,no,No,,No,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,IM 930363,CA,48.0,F,"Patient describes sore arm,",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/19/2020,1.0,WRK,,,,,,['Pain in extremity'],UNK,PFIZER\BIONTECH, 930364,CA,49.0,F,Reported rapid heart rate and chest heaviness and weakness. Symptoms resolved after 1 hour. Eval by MD on site. Employee put in Uber� and told to rest at home. Texted us later and said she arrived home safely and symptoms had resolved. During call 1/6 stated she is still having heaviness in her chest and is using her inhaler. she is following up with her PCP. .,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,PVT,"Albuterol inhaler, Estrogen, Progastrin, Magnesium, Ashwagandha, Vitamin D3",Asthma Postmenopausal Bleed,Asthma Postmenopausal Bleed,,None,"['Asthenia', 'Chest discomfort', 'Heart rate increased']",1,MODERNA,IM 930365,CA,39.0,M,"Dizziness and lightheadedness 20 min post vax Observation and fluids Sxs resolved after 30 mins of close monitoring NKA, but does have hx of asthma",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 930366,TX,62.0,F,Moderna COVID-19 Vaccine EUA Ten days after vaccination the injection site became tender. The eleventh day my left arm at the injection site became red and my arm was swollen and tender to the touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,OTH,"ZINC, VITAMIN D3, VITAMIN C, FISH OIL, HYDROXYCHLOROQUINE (ONE TABLET PER WEEK), PROVITALIZE (WEIGHT MANAGEMENT)",NONE,GOOD HEALTH,,NONE,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",UNK,MODERNA, 930367,OH,53.0,F,"right peripheral photopsia , with floaters and new onset of retina scarring.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,OTH,Synthroid 112 Mcg PO daily,None,hypothyroidism Seasonal allergies,,"Minocycline Seasonal Allergies: hay fever, rag weed, golden rod, grass, mold, dust mites","['Ophthalmological examination', 'Photopsia', 'Vitreous floaters']",UNK,MODERNA,IM 930368,CA,61.0,F,"Began with fatigue and progressed to fever 101.7, severe body aches, severe headache, malaise, cough lasting 24 hours at which time fever subsided with symptoms resolving. Headache persistent.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,COVID-19,None,,None,"['Cough', 'Fatigue', 'Headache', 'Malaise', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 930370,NC,57.0,F,"Pt developed papular pruritic rash over arms, legs abd, face, chest, back (entire body) within 12 hrs of receiving the vaccine. Slight tickle in throat. No fever, no shob, no vomiting at 24 hrs in. Was treated with steroids.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,"Synthroid, Seroquel, HCTZ, Losartan, ropinerole, Meloxicam, Vyvanse, hydrocodone-acetaminophen, flexeril, Wixela Inhub",none,"hypothyroidism, bipolar, htn, back pain after MVA, COPD",,"Buspar, Ibuprofen, hydroxyzine, Wellbutrin, naproxen, erythromycin, tetracycline, lamictal","['Rash', 'Rash papular', 'Rash pruritic', 'Throat irritation']",1,MODERNA,IM 930372,CA,38.0,F,"Received vaccine 1/5/21. On 1/8/21 she felt dizzy and nauseated and fatigued. Blood pressure, pulse, temperature, O2 level all within normal limits.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/08/2021,3.0,PHM,"Hydroxychloroquine, Wixela","celiac, sjogren's, rheumatoid arthirits",,,none,"['Dizziness', 'Fatigue', 'Nausea']",1,PFIZER\BIONTECH,IM 930374,MT,49.0,F,"Metallic taste in mouth after injection. Then 45 minutes later, had rapid heart rate and itching over the injection side. Later that night had itching throughout body. She has since had a HA.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Tylenol.,None,None,,"Cephalexin, doxycycline","['Dysgeusia', 'Headache', 'Injection site pruritus', 'Pruritus', 'SARS-CoV-2 test', 'Tachycardia']",1,PFIZER\BIONTECH,IM 930375,VA,21.0,F,"patient got vaccine at 13:34, went thru observation period, went back to work. Returned to vaccination clinic for complaints of right hand swelling and right arm was the site of vaccination. Patient had elastic wristband on right wrist. Patient does not report loss of sensation in hand, grips equal, no shortness of breath, no swelling of tongue or difficulty swallowing. bp 127/90, hr 108, o2 sat 98%. Benadryl 25 mg liq and Pepcid 20 mg tab administered. 15:20 bp 124/88, hr 112, o2 sat 97%, patient reports that hand was less swollen. and she feels better. 16: 10 patient reorts she feels much better, cap refill < 3 secs, grips equal, decrease swelling of hand, no shortness of breath, no racing of heart, no swelling of tongue or difficulty breathing. 16:30 patient reports they feel fine and left clinic",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,unknown,unknown,unknown,,nka,['Peripheral swelling'],2,PFIZER\BIONTECH,IM 930376,IL,54.0,F,body chills aches and headace,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,WRK,no,no,no,,no,"['Feeling cold', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 930377,CA,35.0,F,"Left hand weakness and tingling, dizziness, injection site throbbing 10 min post vax Observation, fluids, food Sxs largely resolved after 30 mins of close monitoring, returned to shift feeling a little lightheaded NKA",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Asthenia', 'Dizziness', 'Injection site pain', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 930378,IN,52.0,M,"Extreme Chills, Very Cold, Terriable Headache, Nausea, Diarrhea, low grade fever 99.2, No energy, Very Weak. Felt like I had a bad case of the flu. Had to take 1/7/21 and 1/8/21 off of work. My symptoms are better now at 5:49 pm on 1/8/21 but still feeling run down no energy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,Testosterone CYP 200 MG/ML OIL Lisinopril Vitamin C Glucosamine Melatonin Baby Asprin 80 mg,NONE,High Blood Pressure,,NONE,"['Asthenia', 'Chills', 'Diarrhoea', 'Fatigue', 'Feeling cold', 'Headache', 'Impaired work ability', 'Influenza like illness', 'Nausea', 'Pyrexia']",UNK,MODERNA,IM 930380,TN,42.0,F,Patient came through COVID vaccine line stating she had a reaction to the COVID vaccine she received 12/26. Patient's right upper arm had a large red area that was swollen and hot to the touch. Patient reported that it was very itchy. She stated that it did not swell and turn red until about 8-9 days after receiving the injection. Referred to PCP to rule out infection.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,01/04/2021,9.0,PUB,unknown,unknown,unknown,,NKA,"['Erythema', 'Peripheral swelling', 'Pruritus', 'Skin warm']",1,MODERNA,IM 930382,CA,41.0,F,Nausea Injection site really sore Tired Left arm was swelling Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Peripheral swelling']",1,MODERNA,SYR 930383,TX,37.0,F,"vaccine area is itchy, red and swollen on the area of vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,none,none,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA, 930384,WI,32.0,F,"Patient presented for her first vaccination. Patient stated she was very nervous and scared of needles. Patient's skin felt warm. RN talked with patient for close to 5 min and worked through deep breathing exercises to assist in calming her. After the dose, the patient stood up, walked to the opposite corner of the room, and put her long sleeved shirt back on under her scrub top. As the patient began to walk out the door. RN met patient and went to walk with her to the sitting/monitoring room. The patient said she felt dizzy. RN helped the patient to the floor, on her knees, and then to a laying down position. A pillow was placed under her head, cool cloth was placed on her neck. Patient's eyes were rolled back in her head. Patient's skin was warm to the touch. Patient was assisted from the floor to a chair. Patient was pivot transferred to a wheelchair, and transferred to the monitoring room for further monitoring. At this time, the patient stated she felt cold and her hands were very cold to the touch. Patient was monitored by RN. Patient was then transferred to the ED via wheelchair for further monitoring.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,not addressed,not aware of any,not aware,,none,"['Dizziness', 'Eye movement disorder', 'Feeling cold', 'Peripheral coldness', 'Skin warm']",1,MODERNA,IM 930385,CO,37.0,F,"nausea, headache, body aches, general malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,lisinopril 20/hctz 12.5 once daily,none,"diabetes, hypertension",,none,"['Headache', 'Malaise', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 930389,KS,38.0,F,abscess at injection site. Improved with anti-inflammatory medication and oral antibiotics (doxycycline 100mg BID),Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/06/2021,6.0,OTH,birth control pill,none,none,,none,['Injection site abscess'],UNK,MODERNA, 930390,VA,28.0,F,Had intense radiating nerve pain under the left armpit that extended half way down the upper part of the arm & had significant lymph node swelling in the left arm that started exactly one week after getting the vaccine. Lymph node swelling and nerve pain have persisted for at least 5 days now but is starting to decrease.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,PUB,"Nexplanon, Vyvanse, & Metoprolol",,History of SVT,,Penicillin & Cephalosporins,"['Axillary pain', 'Lymphadenopathy', 'Neuralgia', 'Pain']",UNK,MODERNA, 930391,WI,33.0,F,"Pt recieved her vaccine with her husband. 10 min after administration of the vaccine Pt's husband reported that the pt had arm tingling. PT then reported that she had difficulty swallowing and shortness of breath. Pt is a 33 year old female who presents to the ED for evaluation of an allergic reaction that began 10 minutes after the COVID-19 vaccine injection. The pt got the vaccine in her R arm. 10 minutes after injection, the pt began to feel pain and numbness in her R arm. She further c/o dizziness, dry mucous membranes, trouble swallowing, SOB, and a sore throat secondary to swallowing.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Crestor 20 mg Metformin 50 Levothyroxine 25mcg Zanzax 0.5 mg Lexapro 10 mirena device propranolol,Bariatric surgery f/u,"Pt has hx diabetes, HTN, Obstructive sleep apneia , seasonal allergies, anemia",,Contrast Media Bactrim,"['Dizziness', 'Dysphagia', 'Dyspnoea', 'Hypoaesthesia', 'Nasal dryness', 'Oropharyngeal pain', 'Pain in extremity']",1,MODERNA,IM 930392,KS,28.0,F,"patient had redness and itching at the injection site spreading to the entire arm. Redness further spread up the neck and patient had a tickle in her throat. Pulse 101, BP 126/88 and O2 was 98%. Pt was given an ice pack and benadryl then monitored until redness had receded and itching resolved. Pt given instructions to go immediately to the ER if symptoms resumed or she had other allergic reactions. Pt was also instructed to dose with benadryl at bedtime.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,unknown,Covid,unknown,,yes - multiple,"['Erythema', 'Injection site erythema', 'Injection site pruritus', 'Oropharyngeal discomfort', 'Pruritus']",1,MODERNA,IM 930393,CA,39.0,F,Generalized itchy rash of red areas,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,01/04/2021,34.0,WRK,,,,,,"['Full blood count', 'Rash erythematous', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 930394,CA,41.0,F,"EXACTLY 15 MINUTES AFTER THE VACCINE ADMINISTRATION WHEN I FELT LIKE MY THROAT IS CLOSING UP LIKE I CAN'T SWALLOW THEN I FELT MY HR IS BEATING FAST THEN MY FEET AND MY LEFT SIDE OF THE BODY FELT COLD. THAT'S WHEN I RAISED MY HAND AND CALLED FOR HELP. THEY IMMEDIATELY CAME AND ASSESSED ME. THEY PUT MY HEAD DOWN, GAVE ME 02 WITH 2L/MIN AND WET TOWEL ON MY FOREHEAD. THE INITAL BP WAS ABOUT 158/90 111 PER THE MCS. AFTER 20-30 MINUTES OF MONITORING MY SYMPTOMS STARTED TO GET BETTER, THEY TRIED TO SIT ME UP SO I CAN TAKE BENADRYL BUT I FELT DIZZY. SO THEY PUT BACK MY HEAD DOWN AND CALLED 911. TOOK 50 MG OF BENADRYL AND LATER SENT HOME BY PARAMEDICS.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,WRK,NONE,NONE,"ASTHMA, PSORIASIS, PSORIATIC ARTHRITIS",,"SULFAZALAZINE, PEPCID SHOT","['Dizziness', 'Dysphagia', 'Feeling cold', 'Heart rate increased', 'Peripheral coldness', 'Throat tightness']",1,MODERNA,IM 930395,WI,24.0,F,"Pfizer-BioNTech COVID-19 Vaccine Patient was administered vaccine at 0951. Patient reports not feeling well. Got a rush of feeling very warm and shaky. Upon assessment patient is pale, diaphoretic and has a rapid bounding pulse. Moved patient to exam room where we assisted her to lay down. Hooked her up to vitals machine for a set of vitals. HR-140-150, BP 146/88, O2 100%, R-24. Upon patient laying down she started to complain of her throat feeling hot and tingly. She began to develop a blotchy rash first noted above BP cuff on right arm, but quickly spread up neck and down trunk. Assessed mouth and throat, no swelling of tongue or lips noted. Patient still c/o feeling hot and tingly on neck and all the way down to her legs. Blotchy rash had subsided. HR dropping to 80-90 and BP came down to 124/82. O2 remained 100% throughout. Patient transferred to emergency department.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/24/2020,0.0,PVT,,,,,,"['Blood pressure increased', 'Feeling hot', 'Heart rate increased', 'Hyperhidrosis', 'Malaise', 'Nervousness', 'Pallor', 'Paraesthesia', 'Pharyngeal paraesthesia', 'Rash', 'Throat irritation']",1,PFIZER\BIONTECH, 930397,CA,41.0,F,"EXACTLY 15 MINUTES AFTER THE VACCINE ADMINISTRATION WHEN I FELT LIKE MY THROAT IS CLOSING UP LIKE I CAN'T SWALLOW THEN I FELT MY HR IS BEATING FAST THEN MY FEET AND MY LEFT SIDE OF THE BODY FELT COLD. THAT'S WHEN I RAISED MY HAND AND CALLED FOR HELP. THEY IMMEDIATELY CAME AND ASSESSED ME. THEY PUT MY HEAD DOWN, GAVE ME 02 WITH 2L/MIN AND WET TOWEL ON MY FOREHEAD. THE INITAL BP WAS ABOUT 158/90 111 PER STAFF THE MCS. AFTER 20-30 MINUTES OF MONITORING MY SYMPTOMS STARTED TO GET BETTER, THEY TRIED TO SIT ME UP SO I CAN TAKE BENADRYL BUT I FELT DIZZY. SO THEY PUT BACK MY HEAD DOWN AND CALLED 911. TOOK 50 MG OF BENADRYL AND LATER SENT HOME BY PARAMEDICS.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,WRK,NONE,NONE,"ASTHMA, PSORIASIS, PSORIATIC ARTHRITIS",,"SULFAZALAZINE, PEPCID SHOT","['Dizziness', 'Feeling cold', 'Peripheral coldness', 'Throat tightness']",1,MODERNA,IM 930398,AZ,25.0,M,"On December 16th, I received my 1st dose of the COVID-19 Pfizer vaccine at 11:49am. I was off of work for the remainder of the day and driving to an appointment at a different town. Between towns, during the drive fatigue settled in and I started to get drowsy. I switched seats and fell asleep for some time in the vehicle. I had fatigue for about 3-4 weeks following the 1st dose. On December 23rd, my symptoms started to get worse. Headaches increased, muscle pain/aches, chills, fatigue and this was the first day I had a temp of 100.4. I took some Tylenol and it made it bearable for me to continue to work throughout the day. From 12/20-26/2020, I kept feeling like I had a cold or the flu. Through the Holiday, I remained in bed and didn't have energy to do anything. I still had all the symptoms and decided on December 28th to call into work and get seen for a Telehealth. Some lab work were done and test results came back. I'm still working with my provider on figuring out what's going on with me.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/23/2020,7.0,PUB,ERGOCALCIFEROL (Vitamin D) TOPIRAMATE,H PYLORI - Positive (12/02/2020),COVID-19 Long Hauler (05/10/2020),,Not that I know of.,"['Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Helicobacter test positive', 'Impaired work ability', 'Influenza like illness', 'Laboratory test normal', 'Myalgia', 'SARS-CoV-2 test negative', 'Somnolence']",UNK,PFIZER\BIONTECH,SYR 930399,OR,29.0,F,"Had Throat and chest tightness, SOB, pruritis within 5 min of covid immunization. BP: 146/111, P 144; o2 99%, RR 16. She was given albuterol inhaler x 3, Epi-pen x 1, benadryl 25 mg with some iprovement. She was sent to ED. PMHx: tree nut allergy, Hashimoto's thyroiditis, hereditary hemochromatosis, PCOS; Taken to ED",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,albuterol 90 mcg/actuation inhalation HFA aerosol inhaler; MULTIVITAMIN ORAL; fexofenadine 60 mg oral tablet; montelukast 10 mg oral tablet,,"Asthma; Hashimoto's thyroiditis, hereditary hemochromatosis, PCOS",,? Cashews [Tree Nut] Anaphylaxis and Hives ? Hazelnut Anaphylaxis and Hives ? Pistachio Nut Anaphylaxis and Hives ? Flonase [Fluticasone] Headache,"['Blood pressure increased', 'Chest discomfort', 'Dyspnoea', 'Heart rate increased', 'Pruritus', 'Throat tightness']",1,PFIZER\BIONTECH,IM 930400,CA,49.0,F,"inflammation in the vaccinated shoulder (looks like an infected mosquito bite). Redness, itching",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,WRK,Tapazol,none,Graves Disease,,none,"['Erythema', 'Injection site inflammation', 'Pruritus']",UNK,MODERNA, 930402,,,U,"Throat felt clogged, almost passed out, This lasted about 30 secs about 10 mins after injection. Then became very hot and sweaty and started itching all over. This happened about 15 mins after injection and lasted all day. There is now a rash all over my face and small hives on my chest. I have taken 2 benadryl. This is now 7 hrs post injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Dizziness', 'Feeling hot', 'Hyperhidrosis', 'Pruritus', 'Rash', 'Throat tightness', 'Urticaria']",1,MODERNA,IM 930403,IL,39.0,F,I have a fast heart beat with exertion and SOB with exertion.Resting HR 74-80 with minimum exertion like walking around the house HR goes up to 111-136. Started happening from the time I got the vaccine and has not gone away.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,None,None,None,,None,"['Dyspnoea exertional', 'Heart rate increased']",1,MODERNA,IM 930404,FL,68.0,F,RASH ABOUT 3 INCHES CIRCLING VACCINE SITE ALL THE WAY AROUND ITCHY RAISED,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PUB,otc VITAMIN,,,,"INSECTS, PREVIOUS ANAPHYLACTIC REACTION TO BITE UNSPECIFIED INSECT, PROBABLY BEE SULFA- FAMILY ALLERGY","['Injection site pruritus', 'Injection site rash', 'Injection site swelling']",1,MODERNA, 930405,NM,40.0,F,"After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Rapid response called , patient observed for 30 minutes and walked to car. Patient then presented to emergency department at 12:06pm with concern for reaction and h/o heart mumur as a child. Patient referred to Urgent Care Clinic and presented at 12:30, endorsed headache and anxiety. Patient received acetaminophen 1,000mg PO x 1 dose, diphenhydramine 25mg PO x 1 dose, and ibuprofen 600mg PO x 1 dose in Urgent Care. Crackers and water given. Patient provided education on managing anxiety and discharged.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"SUMAtriptan (SUMAtriptan 4 mg/0.5 mL subcutaneous solution) 0.5 mL (4 mg), Subcutaneous, ONCE, PRN as needed for migraine headache, Special Instructions: may repeat once in 1 hour if needed ibuprofen (ibuprofen 600 mg oral tablet) norethi",Unknown,"Migraines, remote history of heart murmur 08/15/86, Seizure grand mal 08/15/86 (resolved)",,"contrast dye, phenytoin, iodine, terconazole, tramadol, cetirizine","['Anxiety', 'Chest discomfort', 'Dyspnoea', 'Headache', 'Photopsia', 'Tremor']",1,PFIZER\BIONTECH,IM 930406,MI,67.0,F,3 days there is rash lower groin. Burning sensation on the left side. Abdominal fold.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,"Norvasc, aspirin.",no,high bp. high cholesterol,,sulfur,"['Burning sensation', 'Rash']",1,MODERNA,SYR 930407,IA,53.0,F,"Nauseous for 30 minutes after vaccine, then reported itchy eyes that felt ""tight"" and stated she had this same reaction with latex allergy. Usually takes Benadryl for it. Treated by NP with po Zofran and po Benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,MIL,"Cymbalta, citalopram, clonazepam",none,anxiety,,"Penicillin, sulfa. mycins, latex","['Condition aggravated', 'Eye pruritus', 'Nausea', 'Ocular discomfort']",1,MODERNA,IM 930408,CA,60.0,F,When got shot my heart rate went up right away. Felt faint. Doctor took blood pressure and was very high. Had me lay down and took blood pressure several more times until it went back down to normal. Took about 20 minutes.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Hormone Replacement Therapy, Zyrtec, Multi-vitamin",None,None,,Amoxicillin,"['Heart rate increased', 'Hypertension', 'Immediate post-injection reaction']",1,PFIZER\BIONTECH, 930410,CA,34.0,F,"On 1/7/2021, I woke up around 0600. I took Allegra and Sudafed. At 0700, I got the shot; waited 30 min; felt fine and left. At 0745, I started itching and developing a headache (on my drive home). At 0800, restricted breathing; took 50 mg of Benadryl (resolved) and 1000mg acetaminophen for headache (unresolved). At 1200, 99.6 F temp with unresolved headache and felt nausea; took 4mg Zofran. At 1300, took 1000mg acetaminophen; temp was 101 F and stomach felt upset so I didn't want to take ibuprofen At 1900, took 1000mg acetaminophen, temp 100.2F; tried to have some soup; my stomach upset and hurts and feels worse with food At 2200, tempt 99.8 F; stomach hurts; achy; itchy; took 600 mg ibuprofen and 50 mg Benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Birth control Benadryl 50 mg on 1/6/2021 @ 2200 Allegra and Sudafed on 1/7/2021 @ 0600,previous allergic reaction to COVID vaccine (dose #1) on 12/17/2020,none,dose #1 of COVID19 vaccine,all nuts and bananas,"['Abdominal discomfort', 'Abdominal pain upper', 'Body temperature increased', 'Dyspnoea', 'Headache', 'Nausea', 'Pain', 'Pruritus']",2,PFIZER\BIONTECH,IM 930412,NH,31.0,F,"Flu-like symptoms including low-grade fever to 100.8, rigors, malaise, fatigue, myalgias (full body, not just right deltoid vaccination site). Also painful and tender right axillary lymphadenopathy. Symptoms began the morning following the second vaccination in the series and have so far lasted for the full day. (Note: I am reporting the symptoms on the day I am experiencing them; they are improved from this morning but not yet resolved.) Notably I had no symptoms after the first vaccination in the series except for very mild transient tenderness of the right deltoid at the vaccination site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,,,,,,"['Axillary pain', 'Chills', 'Fatigue', 'Influenza like illness', 'Lymphadenopathy', 'Malaise', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930413,PA,31.0,F,"Rigors, Fever 102 degrees, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930414,,,F,Numbness of face and light headed 4:37 pm b\p 152/90 pulse76 4:55pm b\p 112/60,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,"['Dizziness', 'Hypoaesthesia']",1,MODERNA,IM 930415,NJ,46.0,F,"Body aches, headache, flu-like symptoms beginning at approximately 4pm on 1/6/21 and lasting until 6am on 1/8/21. Frequent dizzy spells began on 1/8/21 at approximately 10am and continue through the time of this report at 6pm on 1/8/21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,"AREDS2, magnesium citrate, vitamin c, turmeric, vitamin d",,,,Sulfa,"['Dizziness', 'Headache', 'Influenza like illness', 'Pain']",1,MODERNA,SYR 930416,IL,46.0,F,"Case complains of chills, sweats, nausea, severe body aches, stiff neck, headache, restlessness, slight congestion, sinus pain, fatigue 10 hours after receiving immunization. Client slept for several hours and is somewhat better. Client states that she still feel awful and body aches remain.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PUB,,,,,,"['Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Musculoskeletal stiffness', 'Nausea', 'Pain', 'Respiratory tract congestion', 'Restlessness', 'Sinus pain']",1,MODERNA,IM 930417,MA,30.0,F,At the time of the injection I had some tingling in my arm. I had arm neck and shoulder soreness as well which continued for a few days. A couple of hours after the injection I began itching all over. I deduced that it could be an allergic reaction so I took an antihistamine and relaxed.I did not check for hives as I don't know much about allergic reactions. the Itching went away. On day 8 I had the itching again accompanied by hives. Once again I took an antihistamine and improved. On day 11 I had itching again and took an antihistamine. The antihistamine did not work as well this time. It is day 12 as I write this.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,PVT,birth control daily po. botox injections received for hyperhydrosis 4 weeks ago in armpits.,none,migraine. anxiety. ADHD. anemia.,,none,"['Arthralgia', 'Neck pain', 'Pain in extremity', 'Paraesthesia', 'Pruritus', 'Urticaria']",1,MODERNA,IM 930419,GA,33.0,M,I had the vaccine at 0800 on 1/7/2021. At approximately 1300 hours day of vaccine began having diarrhea. At 0200 on the 8th began running 102+ tempature. I have ran a temp on and off all day and have now developed a dry cough.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,None,Sore throat,Ibs,,Morphine and IVP dye,"['Body temperature increased', 'Cough', 'Diarrhoea']",1,MODERNA,IM 930420,IN,52.0,M,"Extreme Chills, Low Grade Temp 99.2, Very Cold, Terriable Headache, Nausea, Diarrhea, Very Weak. I had to take 1/7/21 and 1/8/21 off of work. I am feeling better now, its 6:00 pm on 1/8/21 but I still am feeling weak, headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,Testosterone CYP 200 MG/ML OIL LIsinopril 20 MG Tablet Vitamin C Melatonin Glucosamine Baby Asprin 80 mg,NONE,High Blood Pressure,,NONE,"['Asthenia', 'Chills', 'Diarrhoea', 'Feeling cold', 'Headache', 'Impaired work ability', 'Nausea', 'Pyrexia']",UNK,MODERNA,IM 930421,IN,51.0,F,"Hives on neck and swollen submandibular lymph nodes, swelling of left upper and lower eyelid- benadryl taken, swelling resolved within 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Crestor, Estradiol, vit d, ibuprofen, lysol, flonase",Sinus infection,,MMR,"Seasonal, environmental, dairy,eggs,bananas, onions","['Lymphadenopathy', 'Periorbital swelling', 'Urticaria']",1,MODERNA,IM 930422,FL,36.0,F,"Itchy 'all over', redness to chest and chin. Benadryl 25 mg po provided, improvement noted.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,"Sertaline, Lyrica, Rexulti, Prenatal vitamin, Ativan","Seizure disorder, pituitary gland tumor, 5 months post partum, LEEP procedure 12/2020 for cervical cancer.","Seizure disorder, pituitary gland tumor, 5 months post partum, LEEP procedure 12/2020 for cervical cancer.",,"Levaquin, Shellfish, Fish, Iodine, Betadine","['Erythema', 'Pruritus']",1,MODERNA,IM 930423,WA,80.0,M,"I received a call from the pharmacist at the clinic at 10:30 am on 1/8/2021, to let me know that a staff member at the facility we were at on Tuesday 1/5/2021 developed Bell's Palsy on 1/7/2021. Half of his face went numb and they feared the patient had a stroke. They rushed the patient to urgent care where it was determined it was Bell's Palsy and NOT a stroke. The patient is back home and recovering well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/07/2021,2.0,SEN,,,,,,"[""Bell's palsy"", 'Hypoaesthesia']",1,PFIZER\BIONTECH,IM 930424,SD,41.0,F,"Pfizer COVID-19 vaccine 1 (12/16/20) and 2 (1/5/21): Body aches, chills, fatigue, cold sweats, localized discomfort",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Yasmin,,"Asthma, lumbar back pain with radiculopathy",,Codeine,"['Chills', 'Cold sweat', 'Discomfort', 'Fatigue', 'Pain']",2,PFIZER\BIONTECH,IM 930425,OR,43.0,F,"8 days after vaccine redness, heat, swelling and feels hard around injection site. Area has been outlined and is getting worse. Person recommended to follow up with PCP or urgent care.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,PVT,unknown,unknown,unknown,,none,"['Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA,IM 930428,SC,33.0,M,"Fatigue, chills, fevers, myalgias, malaise, headache, stuffy nose started about eight hours after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Nasal congestion', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930430,CT,57.0,F,Waited 15 minutes after being administered vaccine-left facility and 30 minutes after receiving vaccine the sides of my tongue became numb/tingly. This subsided after 3.5 -4 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Doxycycline 20 mg 500 mg Calcium + 25 mcg D3 gummies x 2 Culterelle Probiotic x 1 capsule,12/1/2020 Kidney stone -12/16/2020 lithotripsy/ureteroscopy/cystourethroscopy procedure 1/5/2021 ureth stent removal,,,Raw almonds/tree nuts,"['Hypoaesthesia oral', 'Paraesthesia oral']",1,MODERNA,IM 930431,CT,,F,"Cardiac event, 2 days after vaccination, patient expired.",Yes,01/08/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,SEN,"Enteric Coded Aspirin, Atenolol, Centrum Silver, Citrical, Levothyroxin, Lisinipril, Phillips Colon Health Caps, Vitamin D",none,"Aortic Stenosis, Status post Tavr procedure, Hypothyroidism, Hypertension, Thoracogenic Scoliosis, Polymyalgia Rheumatica, Heart Valve Replacement, Hyperparathyroidism",,None,"['Cardiac disorder', 'Death']",1,PFIZER\BIONTECH,IM 930432,OH,31.0,F,"headache, fever, chills two days",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,none,COVID infection positive test from 12/23,none,,sulfa,"['Chills', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930433,CT,42.0,F,"After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the waiting area to be monitored and my tongue and lip started itching. I then started w/ a red rash to the R side of my neck. My body started to itch all over. I was brought into a treatment room and my vital signs were being taken when I started to have an increase in coughing, shortness of breath and vomiting. I was given an epipen and brought to the emergency room when I received Benadryl 50mg IV, Solumedrol 125mg IV, and Pepcid 20mg IV. Approximately 1 hour after receiving the medication my face again began to itch and I was given an additional dose of 25mg of Benadryl. My reaction resolved and I was discharged home with a prescription for prednisone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"biotin, vitamin c, vitamin d3, vitamin b12, multivitamin,",none,"s/p gastric sleeve, depression, arthritis, asthma,",,"coconut, codeine, penicillin, tessalon perles,","['Cough', 'Dizziness postural', 'Dyspnoea', 'Lip pruritus', 'Pruritus', 'Rash', 'Tongue pruritus', 'Vomiting']",2,PFIZER\BIONTECH,IM 930434,OR,35.0,M,"Noted tongue parathesias and sensation of tongue swelling after vaccination. Denies SOB, dizziness, C/P, pruritis or rash. BPMHx, no current meds, allergy sulfa.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,None,,,,Sulfa,"['Paraesthesia oral', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 930440,KS,22.0,F,"Patient received 2nd dose Pfizer vaccine tongue swelling, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,none,None,None,,Albuterol,"['Nausea', 'Swollen tongue']",2,PFIZER\BIONTECH,IM 930441,WV,55.0,F,"Within 5 minutes of receiving the shot I had and extreme flushing sensation and tingling go through my entire body, including my mouth and throat. The nurse could see me turning red and feel the heat on my body. My BP and HR were also high. After those symptoms started leaving I became extremely cold. My hands stayed so cold they could not get a reading on my oxygen level. I did not feel short of breath at any time. I had a total of 4 episodes like this with each one being smaller and leaving sooner. They gave me juice and a graniola bar, kept checking my temp and blood pressure. After an hour to hour and half I was released to my son and husband. I took a benedryl whenI left.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,"That morning I took... multivitamin, ommprazole, citalopram, probiotic",,,,"niacin, biaxin, prednisone, pets and seasonal","['Erythema', 'Feeling cold', 'Flushing', 'Heart rate increased', 'Hypertension', 'Paraesthesia', 'Paraesthesia oral', 'Peripheral coldness', 'Pharyngeal paraesthesia', 'Skin warm']",1,MODERNA,SYR 930442,CA,27.0,F,injection site was swollen and hot and doubled in size also reports fatigue and slight discoloration.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/07/2021,7.0,PVT,,,,,,"['Fatigue', 'Injection site swelling', 'Injection site warmth', 'Skin discolouration']",UNK,PFIZER\BIONTECH, 930444,PR,46.0,F,Injection site pain. Muscle pain. Joint pain. Chills. Headache. Eyes pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,OTH,Synthroid 175mg,None,Hypothyroidism,Influenza. Year 2016,Latex,"['Arthralgia', 'Chills', 'Eye pain', 'Headache', 'Injection site pain', 'Myalgia']",2,PFIZER\BIONTECH,SYR 930445,CO,33.0,F,"10 min post vaccine began c/o tingling in lips and tongue. stated felt like her throat was like a balloon being blown up. mild anxiety, no sob or diff breathing. no diff swallowing. brought from lobby to exam room. VS taken. 25mg of po benedryl given and 0.3mg epi given SQ at approx 09:20 sat with patient and monitored VS frequently approx q 10m for 60m. oxygen sats remained 98-99% on RA, resp were 20 ( initially with anxiousness down to 14 by discharge. P ave 80s BP ave 130/70s symptoms began to resolve by 30min and were resolved at 60min and pt was release d home pt called when she returned home ( 1hr drive ) and was feeling well with mild tongue thickness sensation . advised to repeat 25mg of benedryl po at 3pm and 9pm today advised to call Emergency Services for any return of sob diff breathing swallowing or sense of airway closing",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,,Asthma,,None,"['Anxiety', 'Paraesthesia oral', 'Pharyngeal swelling', 'Tongue disorder']",2,PFIZER\BIONTECH,SC 930446,KS,24.0,F,Dec 26th I woke up and I had a severe cough shortness of breath and chills I took sudafed and it helped a little but I was just sore and the 27th we went to an urgent care and tested positive for Covid I felt better by the 31st. I received my second covid shot and I had a fever 102.8 but I havent had symptoms since then,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/26/2020,9.0,PVT,Nuvaring,no,no,,no,"['COVID-19', 'Chills', 'Cough', 'Dyspnoea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,SYR 930447,IL,36.0,F,Running a fever of 100.7 Chills,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Omeprazole Allegra Seasonalle Metformin Hydroclorathiazide,None,Asthma High blood pressure,,Seasonal allergies,"['Chills', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930448,NV,51.0,F,Redness and swelling at injection site. This happened at the time of injection then went away and came back = 1 week after injection & is still there.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,UNK,,No,,,,"['Injection site erythema', 'Injection site swelling']",1,PFIZER\BIONTECH,IM 930449,WI,30.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Patient received vaccine and shortly after was in a chair and experienced a syncopal episode. Pt was caught by staff member, and lowered to the floor. Patient reportedly had two syncopal episodes with brief periods of tremoring. Patient reportedly has prior syncopal history. Patient was A&O x4 when med response arrived. Patient was lying on floor with feet up on chair. Patient had unsteady gait and required multiple staff members' assistance. Patient was then transported to emergency department. While in the elevator, patient had her 3rd syncopal episode. Patient syncopal episode lasted for approximately 20 seconds. Patient regained consciousness and was brought into emergency department.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Gait disturbance', 'Syncope', 'Tremor']",1,PFIZER\BIONTECH, 930450,CA,54.0,F,"Shortly after receiving the vaccine, the patient felt like her throat was swollen and her heart was racing. Her blood pressure was taken in the observation area, and it was elevated. She was monitored in the observation area, and then she was escorted to the Emergency Department for continued observation. Reaction resolved with no treatment while she was in the Emergency Department and she was discharged. She was instructed to follow up with her allergist.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Cetirizine,Recently seen an allergist,,,"Latex, Sulfa, Cephalosporins, Penicillin, Ibuprofen","['Blood pressure increased', 'Palpitations', 'Pharyngeal swelling']",1,PFIZER\BIONTECH,IM 930451,MA,28.0,F,"Entered observation as a ""30 minute"" Observant, r/t her past vaccine (Pfizer first dose). States she was dizzy for about 4hrs after 1st vaccination. Onset 45mins, after 1st vaccination. Became dizzy around (1710) while in observation. This nurse and staff assisted pt to bed to lay down in vaccination clinic. Denies SOB, chest pain, or trouble breathing when asked. Currently remains laying down on bed @ present time (1720). Cold compress applied to help alleviate s/s of dizziness. Still voices s/s of dizziness @ 1730. This nurse asked pt if she would like to be sent to ER. Pt voiced she was ""ok"", and did not want to be sent to ER. Pt called family @ 1730, r/t having a ride home. This nurse insisted to pt that she did not need to drive ""herself"". Pt, left w/ family @ 1750, voices slight dizziness upon leaving. Transported via w/c by this nurse w/ family. Left observation @ 1750.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,,,Lactose Intolerance,Stated she had 3-4hrs of dizziness 45mins from first dose of (Pfizer) she received on 12-18-20.,"Cooper, Seasonal Allergies","['Dizziness', 'Similar reaction on previous exposure to drug']",2,PFIZER\BIONTECH,IM 930452,FL,48.0,F,"COVID Moderna vaccine received 12/31/20. Jan. 7, 2021 R Deltoid started to have redness, itching, warm and hard to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/07/2021,7.0,PVT,"Metformin, Glipizide, Ocella-birth control, Januvia, Lipitor, Flonase, Vitamin C, Zinc, B-Complex, Sleepy time tea, gemfibrozil, protonix.",Fractured coccyx - healing,Diabetes,,Percocet,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 930453,,56.0,F,Patient reported feeling shaky and presented with increased HR and BP five minutes after injection. O2 100% RA. Patient provided with snacks and water. Status monitored during observation of 30 mins. All symptoms resolved at discharge from vaccine clinic.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Blood pressure increased', 'Heart rate increased', 'Nervousness']",2,PFIZER\BIONTECH,IM 930454,TX,41.0,F,"Swelling, redness, heat, itchiness and hardness at injection site that did not appear until one week after the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PUB,"Lexapro, hydroxychloroquine, zyrtec, burspar",No,Rheumatoid arthritis,,"penicillin, seasonal allergies, trees, grass","['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 930455,TN,54.0,F,"Onset January 7.,2021 of nausea, diarrhea, chills and body aches that lasted about 18 hours. Noticed on vaccination arm an area of about 2x2 inches that looked like red petechial hemorrhage that is sore to palpation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/07/2021,9.0,PVT,"Neurontin, Trazadone, Effexor XR, Premarin, Calcium",None,no,,Bactrim-Gi upset EES-Gi upset Lexapro-muscle aches,"['Chills', 'Diarrhoea', 'Nausea', 'Pain', 'Petechiae', 'Tenderness']",1,MODERNA,IM 930456,,36.0,F,"- Almost immediate onset of nausea, sore throat, headache, and sensation of fast heart rate; along with feelings of mild illness (like a cold) and arm pain which is consistent with other vaccination response. - Waited at clinic for 30 minutes as directed due to previous history of anaphylaxis to injected meds (among others). Reported feeling poorly to nurse monitoring people waiting at 30 minute mark, who encouraged waiting longer but did no further assessment. Waited another 15 minutes with no resolution or improvement. Decided to leave and monitoring staff said they could not keep patients if they wanted to leave. - Approximately 15 minutes later (1hr after injection), took one 25mg Benadryl liquid gel as nausea/headache/fast heart rate were consistent with prior allergic reaction and not with prior vaccine response. Those symptoms resolved after 1-2 hours; the feeling of mild illness lingered for approx. 3 days more.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,triamcinolone nasal spray (1-4 spray/side/day depending on symptoms),,"mild/intermittent asthma (associated with exertion and sinus/respiratory infections), ulcerative colitis (mild), eosinophilic esophagitis, myopia",,"latex, NSAIDs, opioids, midazolam, azithromycin, cefdinir, amoxicillin/clavulanate, singulair, ferrlecit, venofer, sulfites pineapple, mango, peanut, tree nut cats, dogs, rabbits, various environmental allergies","['Feeling abnormal', 'Headache', 'Immediate post-injection reaction', 'Malaise', 'Nausea', 'Oropharyngeal pain', 'Pain in extremity', 'Palpitations']",1,PFIZER\BIONTECH,IM 930457,OR,26.0,F,"Vaccinated in left arm 12/29 ? initial soreness Wed 12/30 -Headache onset; pain 5 (out of 10) Thursday 12/31- some pain/soreness in arms and legs; no HA Friday 1/1- pain worse (7 out of 10); temp 99.8; Sat 1/2 cough in the morning, soreness; in the evening pain worse; cough resolved; Sunday 1/3 extreme pain 10 out of 10; presented to the ED; prescribed Toradol and excedrin Numbness and pain in upper and lower extremities, particularly in R arm; 10 out of 10 pain; 101.0 temperature Monday 1/4 temperature down to 99.5 this am (has been taking Tylenol); still experience significant pain Headache that she describes as migraine worsens with standing up, walking, talking Pain in legs, if stands for more than 10 seconds she experiences extreme pain Denies SOB, wheezing, coughing The ED advised her to take Toradol for 48 hours and contact a PCP for follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,None known,None known,None known,,None known,"['Cough', 'Headache', 'Hypoaesthesia', 'Migraine', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 930459,NY,64.0,F,"-burning at injection site. -redness of the face, arms & hands -symtoms began 20 min. after administration of the vaccine -Given Claritin 5mg/5mL, 10mL orally.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,,,,,"eggs, nuts, mangos, beans, wool hydroquinone, rubber, sunscreen","['Erythema', 'Injection site pain']",1,MODERNA,IM 930460,PR,32.0,F,"3 hours after vaccination developed feverish, fatigue, headache and bone ache. Today persist with same symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,WRK,Synthroid 75 mcg daily,None,Hypothyroidism,,None,"['Bone pain', 'Fatigue', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930461,TX,46.0,F,"With in my arm got soar. About four hours later I started getting a head ache and feeling cold, I couldn't get warm, I felt very tired. About the next thirty hours I had body ache and head ache my arm got very heavy and hurt, I did not run a fever but felt very restless and achy. I was very tired and didn't work the following day, didn't have much of an appetite. I had some mild itching on my arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,Daily allergy medicine Montleukast Flonase Multi vitamin Vitamin D Calcium Magnesium Glucosamine,,,,Sufalaforin,"['Decreased appetite', 'Fatigue', 'Feeling cold', 'Headache', 'Impaired work ability', 'Limb discomfort', 'Pain', 'Pain in extremity', 'Pruritus', 'Restlessness', 'Temperature intolerance']",2,PFIZER\BIONTECH,SYR 930462,WI,40.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Patient experienced tingling tongue, odd taste on her tongue and neck swelling. Actions taken: Patient stated she had her own 50 mg of Benadryl with her and had taken it at 1305. She states she has other reactions to medications in the past and it feels the same way. Patient monitored, EMS called and care transferred. Patient was alert and oriented.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,WRK,,,,,,"['Paraesthesia oral', 'Swelling']",1,PFIZER\BIONTECH, 930463,MD,39.0,F,"Severe headache, lightheaded, low BP, feeling woozy, dizzy, halo around all lights, light sensitivity, general weakness, heavy eyes, itchy eyes, exhausted, difficulty concentrating, metal taste in mouth - have felt this way on and off since 30 minutes after getting the shot",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,Birth control,None,"Grade 1 heart murmur, environmental allergies",,Vioxx,"['Asthenia', 'Asthenopia', 'Disturbance in attention', 'Dizziness', 'Dysgeusia', 'Eye pruritus', 'Fatigue', 'Halo vision', 'Headache', 'Hypotension', 'Photophobia']",1,MODERNA,SYR 930464,CA,32.0,F,"On the 31st I developed COVID. Runny nose, back ache, and covid symptoms. I still can't smell nor taste.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/23/2020,4.0,WRK,,,,,,"['Ageusia', 'Anosmia', 'Back pain', 'Post-acute COVID-19 syndrome', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 930465,ME,49.0,F,"Fever 102.3, severe headache and ears aching, chills, body aches, injection site soreness, nausea Still present 33 hours later",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,"Vitamins, asprin",None,Auto immune symptoms,,Erythromycin,"['Ear pain', 'Headache', 'Injection site pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930466,LA,82.0,F,"Fever, shortness of breath and chest pain that resulted in a heart attack a few hours after vaccination",Yes,01/05/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,,,None,"['Chest pain', 'Dyspnoea', 'Myocardial infarction', 'Pyrexia']",1,PFIZER\BIONTECH,IM 930467,MO,30.0,F,"Soreness at the site about 3 hours after the injection followed by headache about 24 hours after. Then about 48 hours after, developed diffuse myalgia and drowsiness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,WRK,,,,,,"['Headache', 'Injection site pain', 'Myalgia', 'Somnolence']",1,PFIZER\BIONTECH,IM 930468,FL,44.0,F,"Beginning at 10:30 pm, I had severe chills and body aches through the night. It felt like the flu but no fever. I slept until 1:30 the next day (1/6) I noticed a rash on the outer border of my left shoulder blade around 1:30 on 1/6. I was tired but ok the rest of 1/6. I felt totally normal on 1/7.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,"Vitamin D, Vitamin D3, Oil of Oregano supplement",No,No,,No,"['Chills', 'Fatigue', 'Influenza like illness', 'Pain', 'Rash', 'Sleep disorder']",2,PFIZER\BIONTECH,SYR 930469,KS,37.0,F,"tongue swelling, throat swelling chest tightness, itching neck",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,None,,None prior to vaccine,"['Chest discomfort', 'Pharyngeal swelling', 'Pruritus', 'Swollen tongue']",2,PFIZER\BIONTECH,IM 930470,CA,33.0,F,"Local reaction slightly below injection site, warmth, redness, itchiness, swelling. Symptoms resolved after 7 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,01/03/2021,7.0,PVT,Multi-vitamin,none,none,,None that I know of,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Local reaction']",1,MODERNA,IM 930471,MI,29.0,F,25 minutes after injection numbness of throat and tingling/prickling at back of tongue. Another 10 minutes later entire tongue tingling/prickling. Another 5 minutes lips began tingling/prickling. Epi-pen administered by military staff present for vaccination. Taken to ER and received a dose of Benadryl and prednisone.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Zoloft, Claritin",None,Asthma,,"Seasonal, cats, guinea pigs, kiwi","['Paraesthesia oral', 'Pharyngeal hypoaesthesia', 'Pharyngeal paraesthesia', 'Throat irritation']",1,PFIZER\BIONTECH,IM 930472,FL,70.0,F,"Very tired, arm pain, burning in chest, stinging down arm, became a deep ache. fever 100.2.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"Synthroid, multivitamin,",no,no,flu shot 2000. Very ill.,"contrast dye, codeine,","['Chest pain', 'Fatigue', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA, 930473,TX,38.0,F,"on day 8, observed a red swelling around the injection site. no itchiness, just red and swollen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PHM,"claritin d, spironolactone, vit d, vit c, otc daily multivitamin","one month prior, beg of December, had bad ear infection and vertigo",,,"propranolol, latex skin allergy","['Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 930474,CA,66.0,M,"Woke up with mild fever, mild headache , fatigue and general malaise.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,None,None,Asthma Hypertension Shoulder and knee osteoarthritis Prediabetes,Flu-like symptoms after a Flu vaccine 5 years ago,None,"['Fatigue', 'Headache', 'Malaise', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930475,MT,35.0,F,"Petechiae running down left arm into hand and left chest. Noticed at approximately 10am 1/7/2021 progressively got worse at about 12:00pm contacted vaccine clinic. They told me I should go to the Emergency Room. Went to Emergency Room and had multiple blood tests performed, all came back okay. They told me to come back if it gets worse. 1/8/2021 petechiae seem to be resolving. Just interesting that it was just on the left side of my body where I received the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/07/2021,15.0,UNK,Multivitamin,none,none,,none,"['Blood calcium', 'Full blood count', 'Metabolic function test', 'Petechiae']",1,PFIZER\BIONTECH,IM 930476,TX,40.0,F,Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Lysine Zoloft Adzenys Evekeo Vitamin d Docusate sodium,None,None,,None,"['Differential white blood cell count', 'Full blood count', 'Glomerular filtration rate', 'Hyperhidrosis', 'Hypersensitivity', 'Loss of consciousness', 'Metabolic function test', 'Pharyngeal erythema', 'Pharyngeal swelling', 'Platelet count', 'Rash', 'Swelling face', 'Swollen tongue']",2,PFIZER\BIONTECH,IM 930477,TX,61.0,F,dizzinesss 30 minutes felt ok afterwards red blotchy shoulder where injection was for 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"estradiol, thyroid medication",,,mmr,,"['Dizziness', 'Injection site erythema', 'Injection site rash', 'Rash macular']",1,MODERNA,IM 930478,CT,39.0,M,Rash/welt at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,WRK,"Vitamin D, B vitamins, zinc, omega 3 algae, taurine, carnitine, creatine, turmeric",None,"Seasonal allergies, anxiety",,None,"['Injection site rash', 'Urticaria']",1,MODERNA,IM 930479,KY,30.0,F,"Developed palpitations and tachycardia with sustained HR in low 100?s (baseline is 55). Febrile to 103, chills, rigors, nausea/vomiting.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,UNK,None,None,None,,None,"['Chills', 'Heart rate increased', 'Nausea', 'Palpitations', 'Pyrexia', 'Tachycardia', 'Vomiting']",UNK,PFIZER\BIONTECH, 930480,WA,35.0,F,Last night I realized I have developed redness and swelling on the site of injection but after 9 days of receiving the injection. I?m also experiencing mild axillary tenderness. It is looking better today but I thought it was strange that those side effects took more than a week to show up. I did experience some pain for 3 days after the injection but it had completely resolved and my arm was looking totally normal until yesterday evening,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,OTH,"Vitamin D 2000 IU once a day Supplements: Collagen peptides Herbal: lion?s mane powder, tulsi tea",None,None,,Not known,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Tenderness']",UNK,MODERNA,SYR 930481,OH,38.0,F,"Fatigue, fever (went up to 104, chills/ sweating, unwell",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,SEN,Omperzole,None,None,,None,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Malaise', 'Pyrexia']",1,PFIZER\BIONTECH, 930482,IL,61.0,F,Chills. Nausea. Headache. Body aches. Flushed face,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,,Sinus infection,Kidney stones. Pulmonary embolism. Blood clots,,,"['Chills', 'Flushing', 'Headache', 'Nausea', 'Pain']",2,PFIZER\BIONTECH, 930483,SD,30.0,F,"generalized pruritis, left arm swelling, redness, tenderness. significant redness and warmth surrounding site of injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Effexor, cyclogyl, aldactone, midrin, tenormin, magnesium, vitamin d3, allegra, multivitamin",,"acid reflux, acute thyroiditis, allergic rhinitis, anxiety, constipation, goiter, hearing loss, hyperhidrosis, gestational hypertension, menorrhagia, migraine, seasonal allergies, superior semicircular canal dehiscence, dry eyes","varicella (12 years old), influenza (dermal? 5 years ago), reacts to TB skin test","adhesive, adhesive tape, doxycycline, kiwi, mango, paroxetine, scopolamine, sumatriptan","['Erythema', 'Injection site warmth', 'Peripheral swelling', 'Pruritus', 'Tenderness']",2,PFIZER\BIONTECH,IM 930484,WY,35.0,F,"Altered Mental Status began the middle of the night of 01/06/21 and 01/07/21 with worsening overall status- definitive symptoms unknown to this reporter, this person was admitted to the local hospital at approximately 1800 01/07/2021. This reporter was not told the admitting diagnosis or any defining symptoms, only that the person was admitted.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/06/2021,01/07/2021,1.0,SEN,Unknown,Unknown,Unknown,,Unknown,['Mental status changes'],1,PFIZER\BIONTECH,IM 930485,IL,41.0,F,"Patient received the vaccine at 220pm via IM in her Left Deltoid. She stated that 10min later her top pallet in her mouth started to swell where she couldn't eat or drink anything. She stated it was tingly. She took 4 Pepcid and stated it felt better. on 1/8 at 1pm she reported a sore arm, cloudy vision, shakiness and a temp of 99.8. She reported to her PCP and her PCP stated not to get the 2nd COVID-19 injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,"Cloralithidone, Vitamin D3 and B12",Positive for COVID-19,Venous Insufficiency,,Latex,"['Body temperature increased', 'Feeding disorder', 'Fluid intake reduced', 'Pain in extremity', 'Palatal swelling', 'Paraesthesia oral', 'Tremor', 'Vision blurred']",1,MODERNA,IM 930486,IN,33.0,M,"Severe muscle and joint pain. Body chills, no fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,UNK,,,,,,"['Arthralgia', 'Chills', 'Myalgia']",1,PFIZER\BIONTECH,SYR 930487,NC,86.0,M,Medical docter state patient has a acute cardiac attack,Yes,01/08/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,SEN,"calcium-D tablet, cholecalciferol, fish oil, melatonin, tylenol,",na,"bph, apraxia, , dysphagia, muscle weakness, alzheimers disease",,cephalexin,['Myocardial infarction'],UNK,MODERNA, 930488,NY,54.0,F,"Numbness left side of face and left side of mouth, numbness with tingling to left side of face Tightness on left face and irritation inside cheek tongue on left side",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/08/2021,7.0,PVT,Synthroid Lopressor Zetia,None,None,,Erythromycin Dilaudid,"['Glossitis', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia', 'Skin tightness', 'Stomatitis']",1,MODERNA,IM 930489,MA,58.0,F,Onset of episodes of l hand rash or pounding. No palpitation. No headache. No flushing. Vision. No vertigo. No out-of-body experience. Lasted <60 seconds every 3-4 hrs She was unsteady sitting when it occurred. Easing up as of 1/7/21 but still occurring at least 2x/day. Now SOB better,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,"Amlodipine, Estrace, Metformin, omeprazole, Orencia (on hold), Semaglutide",,"RA, GERD, HTN, Depression Osteoporosis",,"Doxycycline, Hydrochlorothiazide Hydrocodone, Penicillins","['Balance disorder', 'Dyspnoea', 'Rash']",1,MODERNA,IM 930490,TX,42.0,F,"Patient reported local reaction to the injection site such as bump, redness in circle, pain, burning. she got reaction on 2nd day post vaccination. patient reported that redness is still present on the injection site as of 1/8/21. patient is concerned for getting the second shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PVT,none,none,diabetes mellitus type 1,,none,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Local reaction']",1,MODERNA,IM 930491,NH,36.0,F,"~15 minutes post vaccination patient began to have ""pins and needles"" originating in left arm and then moving to legs. Also states that she had sensation of feeling ""off balance"". This did not get worse with change in position or head movement. It progressed to feeling ""shaky"". VS were obtained and were HR of 68 and regular, BP of 134/82, RR of 14. Pupils PERL with normal EOM. Good tactile sensation bilaterally. Moving extremities with purpose. Skin color was initially normal but became pale while feeling shaky. Patient was placed in a near supine position in her vehicle and was observed 1:1. She was given apple juice which improved her shakiness and she regained color in face. She was able to get out of vehicle and ambulate without assistance with a steady, independent gait. She stated that she was back to her baseline before leaving.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,,,,,,"['Balance disorder', 'Pallor', 'Paraesthesia', 'Tremor']",1,MODERNA,IM 930492,TX,64.0,M,"Tender at injection site. Raised red spot about 1"" x 1/2""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PHM,,,,,,"['Injection site pain', 'Rash erythematous', 'Rash papular']",UNK,MODERNA,ID 930494,VA,35.0,F,"patient received vaccine at 16:45 and moved to observation area. prior to vaccine patient reported that she faints when she gets shots, in the observation area at 16:50 reported she felt nauseated and not well. patient sitting down, elevated feet, bp 143/85, hr 94, o2 sat 96%, drinking water, no reports of swelling, racing heart, shortness of breath. 17:00 glucometer 122, bp 147/97. hr 90, o2sat 98%, patient says she feels nauseated, drinking gingerale. 17:30 patient feet on floor and says she does not feel dizzy. 17:50 patient walking around and reports mild nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,unknown,unknown,unknown,,nka,"['Blood glucose fluctuation', 'Malaise', 'Nausea']",1,PFIZER\BIONTECH,IM 930496,IL,51.0,F,"Today at about 10:20 am began feeling lightheaded, dizzy, with palpitations, HR 100-120s. Also, headache, mild muscle aches, chills. After about 2 hours, did not improve therefore was directed to the ED. EKG was normal. CBC, CMP, TFTs all normal. Was monitored for a couple hours and HR improved. At home it took until 17:40 for HR to consistently be 100 or less.. still feel fatigued, headache, and achy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,Metformin Plaquenil Vitamin D Vitamin. 12 Iron,None,Pre-Diabetes Lupus Migraine Thyroid nodule,,None,"['Chills', 'Dizziness', 'Electrocardiogram normal', 'Fatigue', 'Full blood count normal', 'Headache', 'Metabolic function test', 'Myalgia', 'Pain', 'Palpitations', 'Thyroid function test normal']",2,PFIZER\BIONTECH,IM 930497,WA,46.0,F,"Patient called from clinic about 1 hr after receiving Covid vaccine. She had visible lip swelling and lip itchiness that was worsening. She had no SOB, no C/P, no dizziness, no generalized itching or rash. She has history of allergic reaction to unknown substance leading to ED visit. I advised she go to ED for eval, a friend accompanied her, she did not feel ambulance was necessary.I called report to the ED Addendum on 1/1/2021: When I called, she said that one week later she had a similar reaction of lip swelling to another area of lips.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,cetirizine 10 mg oral tablet; ibuprofen 600 mg oral tablet; Multivitamins with Fluoride (MULTI-VITAMIN ),,,,Imitrex [Sumatriptan Succinate] Nausea She has history of allergic reaction to unknown substance leading to ED visit.,"['Lip pruritus', 'Lip swelling', 'Tryptase']",1,PFIZER\BIONTECH,IM 930500,TN,77.0,M,Moderna COVID-19 Vaccine EUA. Fever of 102.8 after 24 hours. Fever reduced by Tylenol and ice packs. No fever after 12 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PUB,"Venlafaxine Er 75 mg, Memantine 10 mg, Donepezil 10 mg, Atorvastatin 20 mg, lisinopril 5mg, Aspirin 81 mg, Omega 3 Fish Oil, Multivitamin, Move Free tablet",None,None,,None known,['Pyrexia'],1,MODERNA,IM 930501,VA,33.0,F,"Deltoid ache which has since resolved. Ache in Shoulder/axillary joint, has continued through today (3 weeks since the Vaccine dose). Hurts when I left my arm above shoulder height",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,,,Iron deficiency anemia (controlled with iron infusions).,,,"['Arthralgia', 'Injection site pain', 'Pain']",1,PFIZER\BIONTECH,IM 930502,TX,63.0,F,"Severe cough, 102 fever, chills, diarrhea, flu like soreness, sick to stomach, couldn?t sit up, felt generally horrible like I felt with covid back in October. Hoping tomorrow will be better.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Multivitamin, A, C, D, Zinc, synthroid, low dose aspirin, Pepcid AC, topamax",None,Asthma,,None,"['Abdominal discomfort', 'Chills', 'Cough', 'Diarrhoea', 'Influenza like illness', 'Malaise', 'Mobility decreased', 'Pyrexia']",UNK,MODERNA, 930503,,21.0,M,Moderna COVID-19 Vaccine EUA adverse event started as localized myalgia around injection site started around 4:30pm same day as the injection then progressed into a headache and fever of 101 by 11pm that night. Myalgia spread to the entire body and interrupted sleep at 2am. Heart rate was 110 while lying in bed. Took Nyquil for fever and at 1pm on 01/08/2021 fever is down to 99.1.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,None,None,None,,Seasonal allergies to pollen and grasses.,"['Headache', 'Injection site reaction', 'Myalgia', 'Pyrexia', 'Sleep disorder']",1,MODERNA,IM 930504,CT,51.0,F,Myalgias and chills,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,Levothyroxane,None,Hypothyroid,,NKDA,"['Chills', 'Myalgia']",2,PFIZER\BIONTECH,IM 930505,SD,70.0,M,"**Pt c/o 'chest pressure' 15 minutes after covid vaccine. Also c/o lightheadedness. Denies nausea. Pt placed in room and employee from Surgery came over to attach vital signs monitor. Dr. from ER happened to be in this area and checked on pt. Dr. from Surgery Dept. also here. 1700 Pt states he is much better, denies SOB, any chest pressure or pain and denies dizziness or lightheadedness. Pt dischrged at 1705 per ambulation to home. 1644: BP 155/73 P 75 SPO2 96 RA 1654: BP P 72 SPO2 97 T 98.5 1700: BP 146/77 P 67 SPO2 96",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,,none per pt,"DM, HPTN, Kidney failure(nephrectomy)",,pseudoephidrine,"['Chest discomfort', 'Dizziness', 'Nausea']",1,PFIZER\BIONTECH,IM 930506,MD,31.0,F,Started exp. central chest tightness and on site of sternum; interment; started about 5-10 min. after vaccination; last 30-60 seconds - tightness - however didn't feel short of breath or light-headed. It would come about a min. or two apart. Lasted for 30-45 min. Resolved on it's own. They transported me to ER. They listened to lungs; did not hear wheezing. My blood pressure was elevated a little initially - 130/90 which is elevated for me. And then it went back down within that 45 time frame. I was monitored there in ER. They wanted to monitor me in the ER so logistical reasons. Did not have rash or light headness. Released after an hour of observation and symptoms had resolved. Then went back to work. The place of vaccination and ER were the same hospital.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,MIL,GiANDI - Oral Birth Control; OTC multi-vitamin - Dolavant; tr treated with Botox for dystonia,no,Cervical dystonia; migraines,,no,"['Blood pressure increased', 'Chest discomfort', 'Electrocardiogram normal']",1,PFIZER\BIONTECH,IM 930507,AL,62.0,F,"1/8/21 4am woke up with hard chills and freeing no fever. Aching ALL over. felt like the flu. tylenol 1000, every 4-5 hours. began having sharp pains just above my left temple about 3 hours ago. Intermittent.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PHM,"xarelto, cymbalta, lowartan,rhythmol, mirapex, mobic, toprol xl.",none,"hx: AFib, HTN, Depression, Restless leg syndrome.",,Idoine,"['Chills', 'Facial pain', 'Influenza like illness', 'Pain']",1,MODERNA,SC 930508,CA,40.0,F,"Initial itching at injection site, observed and returned to work. Came back ~30-40 minutes later with itchiness in throat and hives to arm. Given Benadryl PO and observed for extended period of time. Symptoms not resolving. Patient transferred to Emergency Department for further care. At that point observed to have full body rash, SOB. Given Epi while in ED. Developed tachycardia, hypotension. Treatment continued.",Not Reported,,Yes,Yes,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,Phentermine (ADIPEX-P) 37.5 mg Oral Cap Hydrocortisone 2.5 % Top Crea cloNIDine HCL (CATAPRES) 0.2 mg Oral Tab tiZANidine (ZANAFLEX) 4 mg Oral Tab traZODone (DESYREL) 50 mg Oral Tab Multivitamin (MULTIPLE VITAMIN) Oral Cap,unknown,,,Acetaminophen-codeine Cymbalta [Duloxetine Hcl],"['Dyspnoea', 'Hypotension', 'Injection site pruritus', 'Rash', 'Tachycardia', 'Throat irritation', 'Urticaria']",2,PFIZER\BIONTECH,IM 930509,FL,39.0,F,"On 01/08/2021 patient came to facility to report swelling in left arm that started on the 01/06/2021 after the vaccination of Moderna. On 01/07/2021, patient reports severe swelling and pain in left arm, and not able to lift, move or turn her arm. Patient reports the pain went up to her neck and she is unable to move nor turn her head. Patient reported a fever on 01/07/2021 of 39C and took 2 pills of 200mg tylenol on 01/07/2021 at night. The next day on 01/08/2021 she reports feeling a lump on her left neck, and came to the facility to be examined.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,None,None,None,,None,"['Injected limb mobility decreased', 'Musculoskeletal stiffness', 'Neck mass', 'Neck pain', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 930510,NY,41.0,F,Employee reports stomach pains and diarrhea since am (1/8/2021). On sight Provider ordered COVID PCR and employee sent home to rest and keep hydrated.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/08/2021,2.0,PVT,"Cymbalta 30 mg po daily, Pro-Air Inhaler PRN, Orthro Tri-Ciclen",None,Depression. Asthma,,"Doxycycline, Tetracycline","['Abdominal pain upper', 'Diarrhoea', 'Impaired work ability', 'SARS-CoV-2 test negative']",1,MODERNA,IM 930511,WV,39.0,F,"Low grade fever, achy arm, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/08/2021,7.0,PHM,,,,,,"['Headache', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 930512,CA,34.0,F,"Pt received Pfizer COVID 19 Vaccine on December 17, 2020. No issues or complaints from DOSE 1. Pt reported to vaccination center on January 7, 2021, to receive second dose and patient received Moderna COVID 19 Vaccine in lieu of Pfizer. At the time of 2nd vaccination dose, no issues or concerns. On January 8, 2021, patient reported to work and was sent from nursing floor by her manager to be seen in ER as she had slight nausea today. PER ED NOTE: No rash/swelling or sob. vaccine was given yesterday. No cp or abd pain. Feels a little tired but otherwise fine per patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,,,,,Clindamycin;Keflex,"['Fatigue', 'Nausea']",2,MODERNA,IM 930514,SD,35.0,F,"Seven days post vaccine, a two inch diameter around the injection site became inflamed, red, swollen, hot to the touch, and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"Simvastatin, birth control, levothyroxine, losartan, spironolactone, effexor, buspar",None,Chronic hypertension (medically controlled),,None,"['Injection site erythema', 'Injection site inflammation', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 930515,MO,36.0,F,"Severe body aches, headache started about 2am, about 10 hours after administration. Fatigue. Fever started about 24 hours after administration, highest reading 101.3. All resolved about 48 hours after administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,,None,,,,"['Fatigue', 'Gaze palsy', 'Pain', 'Pyrexia']",2,MODERNA,IM 930516,CT,54.0,F,localized cellulitis,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,,,,,,['Cellulitis'],1,MODERNA,IM 930517,TX,63.0,F,"Patient reported local reaction to the injection site such as bump, redness in circle, pain, burning. she got reaction on 2nd day post vaccination. patient reported that redness is still present on the injection site as of 1/8/21. patient is concerned for getting the second shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,denies,denies,denies,,denies,"['Injection site erythema', 'Injection site pain', 'Injection site reaction', 'Injection site swelling', 'Local reaction']",1,MODERNA,IM 930518,MD,33.0,M,"After about 15 min: hr went to over 170bpm , flushed sensation, brain fog, was driving at the time and my brain wouldn?t figure out how to call 911 , eventually I figured it out but it took extreme mental effort. Paramedics came and my pulse was From 100 - 170 changing rapidly, bp 150-175/x changing rapidly, symptoms would come and go about 8 times on way to hospital. In ER same thing then about 2 hrs go by and then all started again. Pulse remained at 90- 100bpm at least until 2am. (My resting hr is between 40 and 50, my normal bp is usually sub 120/80) I later realized my hands were swollen, mostly on my left side. Lingering symptoms include brain fog, tiredness, and headache. Maybe an exasperating issue was I had low potassium levels likely making symptoms worse - I worked out heavily early in the morning, probably had low intake of potassium that day and day before, and maybe slightly dehydrated from my workout - I do Functional lifting, run, and other types of exercise regularly.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,None,None,"Dupuytrens, plantar fibromatosis, peyronies",,None,"['Blood potassium decreased', 'Blood pressure abnormal', 'Dehydration', 'Echocardiogram normal', 'Electrocardiogram normal', 'Fatigue', 'Feeling abnormal', 'Flushing', 'Headache', 'Heart rate increased', 'Peripheral swelling', 'Pulse abnormal']",1,MODERNA,IM 930519,WI,55.0,F,1/7/2021: 1200 PM H/A 1700 - 1100 PM Chills with continued shaking 1100 PM Febrile 102.5 1100 PM Swollen/Painful lymph nodes -left axilla,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,Metformin Terbinafine Venlafaxine Celecoxib Vit. D3,,DM-2 CLL Asthma,,,"['Chills', 'Headache', 'Lymph node pain', 'Lymphadenopathy', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930520,CO,39.0,F,Employee received COVID vaccine on 1/6/2020 and developed bilateral hip pain that night and then developed numbness and tingling in her buttocks and both legs on 1/7/2020. Employee was sent into Emergency Room.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Arthralgia', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 930521,CO,38.0,F,"cellulitis - prescribed antibiotic, which I am picking up this evening. Not sure of outcomes.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,UNK,"Birth control, fish oil, folic acid",,,,,['Cellulitis'],UNK,MODERNA, 930522,UT,40.0,F,"Severe body aches, chills, headache, fever, joint pain, back pain, fatigue, brain fog, diarrhea, loss of appetite",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,OTH,Alprazolam,None,None,,None,"['Arthralgia', 'Back pain', 'Chills', 'Decreased appetite', 'Diarrhoea', 'Fatigue', 'Feeling abnormal', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 930523,FL,33.0,F,Warm red itchy rash at injection site- occurred 9-10 days after injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,OTH,None,None,"PCOS, SVT",,None,"['Injection site reaction', 'Injection site warmth', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 930524,NM,74.0,F,"Hives, recurrent after 1 dose dexamethasone and benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,Famotidine Calcium acetate Acetaminophen Losartan Carvedilol,"ESRD, on HD Recovering from presumed non-COVID community acquired pneumonia","Hx of COVID infection, June 2020",,Penicillin Sulfa drugs,"['Full blood count normal', 'Urticaria']",UNK,PFIZER\BIONTECH, 930525,TX,51.0,F,"Patient received vaccine at 13:30. She started feeling anxious after receiving vaccine but went back to work. Patient received 50 mg of diphenhydramine at 14:30, she then started experiencing hives and shortness of breath. She was administer 0.3 mg of epinephrine into the thigh and EMS was called.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,SEN,Unknown.,Unknown.,Unknown.,,B-12 injections.,"['Anxiety', 'Dyspnoea', 'Urticaria']",1,PFIZER\BIONTECH,IM 930526,MI,50.0,F,"An incident occurred where a resident received the Covid vaccine twice. The facility incorrectly split the residents in two units. The resident that was listed in Unit 2 was actually from unit 1. The facility is a single floor building. The first dose was administered by team 2 at 12:01 PM and the second dose was given by team 1 at 12:48 PM. Prior to vaccinating the residents. A store intern, informed the nurse, that a consent form was missing and nurse insisted she had one and to vaccinate her. The consent form was actually with the Unit/team 2. The patient is alert and oriented and is not experiencing any symptoms or side effects. She has been checked on every 30 minutes and is doing fine. The facility?s administrator documented the incident apologized for the mistake.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,SEN,,,,,,"['Extra dose administered', 'No adverse event']",1,MODERNA,IM 930527,PR,28.0,F,rash and itching on both eyes. Administered Benadryl IM 50mg as ordered by doctor. Was kept under observation for 15 min. Patient left in stable condition.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,"['Eye pruritus', 'Rash']",UNK,MODERNA,IM 930528,NY,37.0,F,"1 minute after injection: light headed, dizziness 3 minutes: headache 15 minutes: chills, headache, dizziness , arm pain at injection site 40 minutes: malaise, headache, chills, dizziness, arm soreness at injection site All symptoms continued for over 24 hours before subsiding.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,None,No,,None,"['Chills', 'Dizziness', 'Headache', 'Injection site pain', 'Malaise']",1,MODERNA,SYR 930530,CA,52.0,F,Feeling hot and fatigued around 2:00pm. Itchy water eyes in the afternoon/evening. Took Claritin and that helped a little but symptoms lasted until next morning (12/29/20).,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,"Levothyroxine 75mcg Atorvastatin 20mg Isoflavonas: calcium, magnesium, vitamin D3 and K2 120mg Lysteda: Acid Tranexamico 650mg Complex B with diclofenac 3 injections",Diagnosed with Covid-19 illness 11/23/2020.,No,,General anesthesia not sure which one but this one is not used in the US (it is in Mexico). Patient forgets the name.,"['Eye pruritus', 'Fatigue', 'Feeling hot', 'Lacrimation increased']",1,MODERNA,IM 930531,UT,37.0,F,"At 6p.m I started developing a fever of 100 F , chills and became really tired. This continued throughout the night and the next day. I also experienced rigors from about 10:30 to 11:00 p.m. on 12/30/2020. I was completely exhausted as well. I occasionally felt nauseous but did not experience any vomiting or other GI symptoms. All symptoms resolved around 08:00 on 1/1/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Nausea', 'Pyrexia']",1,MODERNA,IM 930532,CA,30.0,F,throat felt different to swallow,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,,,Anxiety,,regaln,['Oropharyngeal discomfort'],1,PFIZER\BIONTECH, 930533,MT,36.0,F,"Heart palpitations, headache, body aches for 48 hours after receiving shot",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,vitamin D,None,None,,No,"['Headache', 'Pain', 'Palpitations']",1,PFIZER\BIONTECH,IM 930534,FL,32.0,F,Left Underarm soreness and tenderness lasting for 16 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/20/2020,3.0,PVT,Vitamin D3 Allegra 24 hour Zanaflex Omeprazole,,Asthma,,Environmental pollen allergies Azithromycin,"['Axillary pain', 'Tenderness']",UNK,PFIZER\BIONTECH,SYR 930536,TN,59.0,F,"3 weeks ago tomorrow, The day after my shot I was really tired. I went to bed and when I got up and had a fever, horrible joint and leg pain, horrible leg pain, terrible bouts of nausea until I couldn't puke anymore. I went into the ER and got fluids and they ran tests and everything was normal. ER said it could be a moderate reaction to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/25/2020,12/26/2020,1.0,WRK,"Synthroid, Prilosec. multivitamin",,"Gerd, hypo thyroidism",,,"['Arthralgia', 'Chest X-ray normal', 'Fatigue', 'Full blood count normal', 'Influenza virus test negative', 'Metabolic function test', 'Nausea', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting']",1,PFIZER\BIONTECH,IM 930537,NC,32.0,F,"Today 10 days post vaccination around 12pm Two spots in left arm formed, are one is slowly growing in size. One spot is red and warm to the touch (this is the one growing) it is slightly itchy. The other spot is a bruise with a red circular spot surrounding it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/08/2021,10.0,PVT,"Ambien CR, Celexa, Seroquel, Lamictal, klonopin",None,Obesity Insomnia Anxiety Depression,,Codeine,"['Contusion', 'Pruritus', 'Rash', 'Skin warm']",1,MODERNA,SYR 930538,CA,30.0,M,"Uncertain if truly caused by the vaccine. I had an ACL reconstruction done back in May of 2020. My knee has transient swelling that comes and goes, but is not particularly frequent. 3 days after receiving the vaccine, my knee swelled up and remained swollen for about 7 days. It has since gone back down. I did not have any acute injuries or remarkable events happen during this time other than the vaccine administration. Overall, uncertain if it was caused by vaccine, but it was odd enough to report.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/26/2020,3.0,UNK,None,None,None,,None,['Joint swelling'],1,PFIZER\BIONTECH,IM 930539,CA,47.0,F,"Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside my throat. Then I began to have difficulty swallowing my saliva. And then the lump inside my throat started to feel larger and larger. By this time Dr had already injected me with Epipen and the pharmacist injected me with Solumedrol and I still felt as if I was having difficulty breathing and then I was taken to ER and I really can't remember too much after that. I was very groggy and then I was discharged from ED about 9:30 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,PVT,multivitamins,None,"Hypertension, overweight",,"bee stings, hair dyes","['Dry throat', 'Dysphagia', 'Dyspnoea', 'Sensation of foreign body', 'Somnolence', 'Throat irritation']",1,PFIZER\BIONTECH,IM 930540,OR,35.0,F,"itching, hot, high blood pressure Blood pressure has gone down but is still high.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,UNK,None,None,Diabetes,,None,"['Feeling hot', 'Hypertension', 'Pruritus']",2,MODERNA,SYR 930541,TX,17.0,M,no side effects or symptoms at time of dose or observation time. reporting because of patient age,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PUB,unknown,unknown,"hypertension, obese",,unknown,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 930542,IN,22.0,M,"I?ve been experiencing mild fevers (99.4-100.3), migraines, soreness and fatigue approximately ~48 hours after receiving my booster",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/08/2021,2.0,MIL,None,None,None,,None,"['Fatigue', 'Migraine', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 930543,TN,59.0,F,"3 weeks ago tomorrow, The day after my shot I was really tired. I went to bed and when I got up and had a fever, horrible joint and leg pain, horrible leg pain, terrible bouts of nausea until I couldn't puke anymore. I went into the ER and got fluids and they ran tests and everything was normal. ER said it could be a moderate reaction to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/25/2020,12/26/2020,1.0,WRK,"Synthroid, Prilosec. multivitamin",,"Gerd, hypo thyroidism",,,"['Arthralgia', 'Blood test', 'Fatigue', 'Nausea', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting']",1,PFIZER\BIONTECH,IM 930544,CA,26.0,F,nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,OTH,,,,,,['Nausea'],1,MODERNA, 930545,,42.0,F,"Arm and facial swelling, metallic taste in mouth, dizzy and lightheaded within a few minutes after vaccine. Benadryl 50mg IM given then taken to the ED for further evaluation and treatment",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PVT,,,,,sulfa- rash lisinopril- angioedema,"['Dizziness', 'Dysgeusia', 'Peripheral swelling', 'Swelling face']",UNK,MODERNA,IM 930546,CA,62.0,F,"Fever 100.6 F , chill, headache, pain",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,UNK,none,none,,,none,"['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 930547,IN,29.0,F,2 hours after receiving vaccine started having severe pain in shoulder. Progressively got worse as the night went on. Jolting sharp pain with certain movements.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Phentermine, prenatal, vitamin c",None,None,,None,"['Arthralgia', 'Pain', 'Ultrasound scan']",UNK,PFIZER\BIONTECH,IM 930548,WA,45.0,M,"While on duty and in uniform as an emergency paramedic I received my second scheduled covid19 vaccination. Approximately five minutes after receiving C19 dose 2 vaccination (1335hrs). I experienced a syncopal episode while walking back to my work area and was lowered to the ground by another EMS provider. I was then placed in a wheelchair by the EMS provider and an RN and taken to the emergency department at Medical Center. (1337hrs) I regained alertness and felt severe nausea and general weakness and was assisted into in ER bed. Staff doctor attended along with RN . An assessment was completed, 12 lead EKG completed, IV established, 8mg Zofran administered, 1000ml of Normal Saline was bolused. Labs were drawn. ED staff continued to monitor me for the next 2 plus hours I was monitored for anaphylaxis and other symptoms. My symptoms of nausea mostly resolved and my strength returned. A Resident MD completed a final evaluation and determined it was safe for me to be discharged. (1607hrs)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,MIL,none,none,none,,Penicillin,"['Asthenia', 'Blood urea increased', 'Blood urea nitrogen/creatinine ratio increased', 'Electrocardiogram', 'Haematology test', 'Laboratory test', 'Nausea', 'Syncope']",2,PFIZER\BIONTECH,IM 930549,WV,58.0,F,"I had a mammogram on 1/6/2021. The mammogram showed that I had inflamed lymph nodes in my left breast, which is the same side on which I received the injection (left arm). I had an ultrasound the same day. The same radiologist read the mammogram and the ultrasound. There were multiple axillary lymph nodes on the left side.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/06/2021,13.0,PVT,,,,,,"['Lymphadenopathy', 'Mammogram', 'Ultrasound breast']",1,PFIZER\BIONTECH,IM 930550,FL,40.0,F,The next day had headache and right axillary swelling and tender right axillary lymph nodes.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,None,None,None,,None,"['Headache', 'Lymphadenopathy']",2,PFIZER\BIONTECH,SYR 930551,IN,23.0,F,"Nauseous, hot, cold, fatigue, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,MIL,"Escitalopram, montelukast",,,,,"['Fatigue', 'Feeling cold', 'Feeling hot', 'Headache', 'Heat therapy', 'Nausea']",2,PFIZER\BIONTECH,SYR 930552,WA,44.0,F,"I am a physician and received 2 doses of the Pfizer COvID vaccine. First dose 12/20/20. Second dose 1/6/2021. Forty- eight hours after second dose I had moderate to severe under eye swelling at site of dermal fillers I received May 20,2020 requiring steroids and antihistamine. I also had severe myalgias and fever 12 -36 hours after my second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,WRK,Atorvastatin History of under eye dermal fillers injected 5/20/2020 History of lip cheek fillers injected 12/09/2020,No,Asplenia since 1989,,None,"['Eye swelling', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930553,,54.0,F,"Patient reported red injection site, itchy throat and cough while being monitored. Patient was taken to emergency department for evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,Hydrochlorothiazide 25mg oral daily Promethazine/dextromethorphan Albuterol HFA daily as needed Propranolol 80mg oral daily,,High cholesterol Hypertension,,NKA,"['Cardiac monitoring', 'Cough', 'Injection site erythema', 'Oxygen saturation', 'Throat irritation']",2,PFIZER\BIONTECH,IM 930554,NC,53.0,F,Low back pain so I went to neuromuscular massage where I go 1-2x a month. My back seized up in so much pain I could not get off the table. I had to stay another hour and still had to crawl off onto the floor before I could drive home.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,SEN,"Lexapro 20 mg, Vyvanse 10 mg",Swollen left knee,No,,Narcotics,"['Back pain', 'Mobility decreased', 'Muscle spasms']",1,MODERNA,SYR 930555,OR,42.0,M,"Went to ED 6 days after vaccination. ""42yoM with a hx of covid-19 infection in 3/2020 with sequelae of chest pain, insomnia, SIBO, and distant hx of testicular malignancy who presents with chest pain and chest palpitations. �Pt received COVID vaccine on Monday, then started to have symptoms reminiscent of his original covid infection on Wednesday, including chills, myalgias, substernal chest pain, heart palpitations, and fatigue. Denies any fevers recorded at home. He feels like he has extra beats intermittently. Also reports some nausea, but denies vomiting or diarrhea. He has maintained good PO intake since symptoms started, but is worried he may be a bit dehydrated because he had a small AKI when he had covid back in March?. Etiology of chest pains unclear, but given all of the above workup, unlikely to be due to an acute cardiac or pulmonary etiology."" He continued to have palpitations for the next week and had further EKG's don thru urgent care.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/27/2020,6.0,PVT,None,Covid infection 3/2020 with prolonged course.,? Testicle cancer � ? Amblyopia � ? GERD (gastroesophageal reflux disease) � ? Migraine,,"? Adhesive Tape Rash � � Pt reports rash with ""certain type of plastic tape"" ? Iodinated Contrast Media Edema � � Pt reports ""facial swelling"" with contrast �","['Chest pain', 'Chills', 'Dehydration', 'Electrocardiogram', 'Electrocardiogram ambulatory', 'Fatigue', 'Myalgia', 'Nausea', 'Palpitations']",1,PFIZER\BIONTECH,IM 930556,TX,60.0,F,"Injection site was swollen and tender to touch from Thursday until Sunday, then subsided. On Thursday, injection area began to itch. Then large area surrounding site became firm. No pain. Size approximately that of human palm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PHM,Venlafaxine XR 75 mg,None,None,,None that I'm aware of.,"['Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA,IM 930557,NY,42.0,F,"Red,blotchy generalized rash and lethargy noted day after vaccine. Evaluated in Urgent Care, and sent for consult with allergist. Dr. prescribed course of prednisone and recommends employee not receive second dose. Dr. notes that employee has had positive COVID titers in the past.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,none,none,none,,NKA,"['Lethargy', 'Rash', 'Rash macular']",1,MODERNA,IM 930558,CO,70.0,F,"Patient was waiting out her 15 mins in the waiting room after receiving the first dose of her Moderna COVID19 vaccine when she began to fill like her tongue was a little swollen. Brought patient into an exam room and took her vitals at 1028 which were BP 135/83, HR 82, O2 96%, and RR 15. Also looked at patients throat to assess signs of angioedema or restricted airway. Patients tongue did appear swollen and was unable to clearly see the back of her throat. 1020 IM Benadryl 50mg was given per standing order and retook vitals at 1032 vitals remained stable at BP 131/52, HR 79, and O2 96%. Patient was moved to a more private room and laid down on a yoga matt for 15-20 min. She began to feel better and continued to be able to swallow and maintain airway. Tongue swelling does appear to have decreased. Could not see uvula but patient states she is not sure if you ever can she may have different anatomy. Vital taken for final time around 1100 and were BP 125/76 O2 96% and HR 74 which she says is normal for her. Made patient aware that after her husband drives her home that she should monitor symptoms and if they become worse she needs to call 911. Scheduled second dose of vaccine but told her to anticipate getting vaccine in Urgent care if okay with Director.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,unknown,unknown,unknown,,unknown,['Swollen tongue'],1,MODERNA,IM 930559,MI,46.0,F,Fine rash (almost petechiae appearance) upper body appeared 18 hrs post-injection - still present Facial flushing accompanying rash Severe body and joint aches appeared 18 hrs post-injection - responsive to ibuprofen-still present Severe headache appeared 16 hrs post-injection - responsive to Excedrin/Tylenol - still present Low-grade fever 100.1F (taken 3 hrs post ibuprofen),Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,"Zyrtec, Prilosec, B-complex vitamin, Vitamin D-3, Green Tea extract, Ibuprofen, Zinc, Elderberry, tranexamic acid",Nausea and diarrhea in the week prior accompanied by mild malaise. GI symptoms attributed to monthly menses but symptoms worse than normal and husband also had mild GI symptoms.,Obesity Sleep apnea uses CPAP menorrhagia,,Phenobarbitol,"['Arthralgia', 'Flushing', 'Headache', 'Pain', 'Pyrexia', 'Rash']",2,PFIZER\BIONTECH,IM 930560,OH,60.0,F,"shaking chills, fever, myalgias, fatigue increasing over course of 8-24 hours after injection; severe enough that could not work",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,"levothyroxine, metformin, pramipexole, bupropion, methylphenidate, zolpidem",none,"hypothyroidism, depression, insomnia, attention deficit disorder",,none,"['Chills', 'Fatigue', 'Impaired work ability', 'Myalgia', 'Pyrexia', 'Tremor']",1,MODERNA,IM 930561,OK,32.0,M,-Swollen left supraclavicular lymph nodes (1 medium and 1 large that are hard like marbles) -Entire left supraclavicular fossa region is swollen around hardened lymph nodes,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,UNK,Testesterone cypionate Adderall,Covid within 4 weeks prior to vaccine,None,,Allergy to Haldol - swollen uvula,"['Induration', 'Lymphadenopathy']",1,PFIZER\BIONTECH,SYR 930562,MI,49.0,F,"1/7/2021 I was extremely tired and could not raise left arm without assistance. I also, experience quit a bit of pain at the injection site. Arm pain decrease the next day and was able to raise arm without assistance. 1/8/2021 Tired and lightheaded. I felt like I would pass out if I did not sit down. Cannot stand on my feet longer than 30 minutes at a time. Also experience shortness of breath.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,"Singulair 10mg, Spiriva Respimat 1.25 mcg, Zioptan, and Nature's Bounty Hair, Skin, and Nails.",No,"Asthma, and Glaucoma",Varicella,"Penicillin, and Sulfur.","['Dizziness', 'Dyspnoea', 'Dysstasia', 'Fatigue', 'Injection site pain', 'Joint range of motion decreased']",1,PFIZER\BIONTECH,IM 930563,CO,24.0,F,"Client became dizzy 10 minutes into her waiting period. Laid prone X 10, drank juice then sat X 10 and escorted to husbands car.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,No,No,No,,No,['Dizziness'],1,MODERNA,IM 930564,CA,36.0,F,"During observation period, patient developed itching in her throat that did not resolve on its own. Was given 50mg PO of Benadryl and observe for another hour. Sx resolved and patient went home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"oxyCODONE (ROXICODONE) 5 mg Oral Tab Ondansetron (ZOFRAN) 4 mg Oral Tab Docusate Sodium (COLACE) 100 mg Oral Cap Ondansetron (ZOFRAN) 4 mg Oral Tab oxyCODONE (ROXICODONE) 5 mg Oral Tab STOOL SOFTENER 100 mg Oral Cap PAIN RELIEF,",,,,Codeine Imitrex [Sumatriptan],['Throat irritation'],1,MODERNA,IM 930565,CA,41.0,F,"Dizziness, unable to walk but she is okay now",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,Vitamin D,,,,,"['Dizziness', 'Gait inability']",UNK,PFIZER\BIONTECH, 930566,MA,35.0,F,Noticed a tingling sensation in her left arm radiating down to her fingertips on 12/31/2020. Redness at the injection site and hives on the left arm where injection was given. Patient went to ER on 01/01/2021 due to numbness and tingling. Received Benadryl at the ER.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,WRK,No,No,"Asthma, Anemia, Hypertension",,"Bactrim, Trimethoprim, Sulfamethazole Doxycycline","['Hypoaesthesia', 'Injection site erythema', 'Injection site urticaria', 'Paraesthesia', 'Urticaria']",1,PFIZER\BIONTECH,IM 930567,TX,17.0,F,patient had a syncopal episode at time of injection. lasted <10 seconds. Also reporting due to patient age 17 years old. Patient stated she thought she could take vaccine so she registered for it.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,none,none,none,,none,"['Immediate post-injection reaction', 'Product administered to patient of inappropriate age', 'Syncope']",1,MODERNA,IM 930569,ME,38.0,M,"12/30/20 pressure in neck (like someone cupping it), mild 12/31/20 myofacial fatigue, jaw fatigue/weakness making chewing difficult 1/2/21 numbness and tingling in hands, worse left. Global mild analgesia 1/3/21 paresthesias in hands and feet. Legs weak, left worse than right. Severe myofacial fatigue. Headache. Malaise. Severe neck pain 8/10, general body pain 5/10 1/4/21: lymphadenopathy left deep cervical chain. Significant, visible through skin, easily palpable. Other symptoms improved 50% 1/8/21 (today) lymphadenopathy ongoing and unchanged, still severe. Assessed by PCP, felt to be adverse event. Still some paresthesia in hands, malaise.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PVT,pantoprazole clonidine lamotrigine hyocyamine prn allegra prn,none,GERD spinal stenosis bipolar 2 disorder,,NKA,"['Headache', 'Hypoaesthesia', 'Jaw disorder', 'Lymph node palpable', 'Lymphadenopathy', 'Malaise', 'Mastication disorder', 'Muscle fatigue', 'Muscular weakness', 'Musculoskeletal discomfort', 'Neck pain', 'Pain', 'Paraesthesia']",1,MODERNA,IM 930570,MA,34.0,F,"Patient woke up at 10:30am on 1-6-21 with her (L) upper arm itchy. Area of injection was red, swollen, and hot to touch. Patient saw PCP on 1-6-21 and was prescribed a prednisone taper, Atarax, and betamethasone cream. As of 1-7-21 the area is still red and swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,none,none,no,,gluten,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 930571,MA,24.0,F,"On 1-721 at approximately 8pm. patient started with itching to the (L) deltoid. Patient then noticed that (L) deltoid injection site was red & swollen. Patient works in PCP office & was evaluated by PCP. Prescribed prednisone taper, Atarax, & betamethasone cream on 1-8-21. Still with redness/swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,none,no,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 930572,NH,29.0,F,(L) upper arm Cellulitis,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,PVT,,,,,,['Cellulitis'],UNK,UNKNOWN MANUFACTURER, 930573,AZ,50.0,F,"Patient reported the following to employer via email on 1/8/20201: ""I have been experiencing a reaction to the vaccine all week and this morning it got worse. I called my doctor and they want me to go to urgent care this morning. She told me that 100% of healthcare workers are seeing the same thing 7-10 days after the Moderna vaccination. My lymph node (armpit where vaccination was administered) is swollen and painful, neck hurts, and have a very low fever. The vaccination site is swollen, warm, hard and has a red circle below injection site that was the size of a nickel day 1 but now it takes up my entire deltoid region"".",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/07/2021,7.0,PVT,unknown,unknown,unknown,,unknown,"['Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site warmth', 'Lymph node pain', 'Lymphadenopathy', 'Neck pain', 'Pyrexia']",1,MODERNA,IM 930574,FL,34.0,F,"Severe nausea, fatigue Tunnel vision, and delayed speech. Lasting 15 min.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,UNK,,unknown,,,,"['Fatigue', 'Nausea', 'Speech disorder', 'Tunnel vision']",1,MODERNA,IM 930576,NY,53.0,F,(L) Deltoid has been warm since vaccine. She Noticed redness to injection site on 1/5/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,WRK,None,None,None,,None,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,IM 930577,NY,38.0,F,Developed site redness 9 days after vaccine. Arm is warm & hard at site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,WRK,"Baclofen, Topiramate",,Migraines,,None,"['Injection site erythema', 'Injection site induration', 'Injection site warmth']",1,MODERNA,IM 930578,NY,51.0,F,Notice lymph node swelling on left side on 1/7/20. Had vaccine 12/30/20. Just stopped sinus infection treatment on 1/7/21,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,WRK,"Rosuvastin, Humalog, tresiba",Sinus Infection,Diabetic,,"Sulfur , shellfish",['Lymphadenopathy'],1,MODERNA,IM 930580,TX,56.0,F,"1/2dollar size red circle @ injection site. Low grade fever Runny nose, itchy watery eyes, earache, allergy symptoms. Fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,Plaquenil. Benicar,SLE,SLE,,"Codeine, seasonal allergies, dairy","['Ear pain', 'Eye pruritus', 'Fatigue', 'Hypersensitivity', 'Injection site erythema', 'Lacrimation increased', 'Pyrexia', 'Rhinorrhoea']",UNK,MODERNA,IM 930581,OR,62.0,F,"Pfizer-BioTech COVID-19 Vaccine EUA 24 hrs post vaccination I started feeling fatigued, muscle and headaches which seemed to move around my body for about 24 hrs. At one point it seemed to settle into my hand. Knuckles swelled arthritis like. When walking up stairs I had significant muscle weakness in my legs and exertional dyspnea. Eyes felt ""feverish"" but had no fever. The next morning while trying to do a routine workout the same thing happened. It was a significant change to my normal condition. The dyspnea was the most concerning. The body aches settled into my lower back. Fatigue was moderate-moderately severe. As the day went on things waxed and waned. By the end of 72 hrs. most symptoms subsided. Friday 01/08/2021 I had a completely normal workout, no exertional dyspnea, fatigue subsided, no body aches. Back to normal. I would consider the symptoms to have been Moderate+.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,"linsinapril, synthroid, BiFlex",,"Hashimoto's, HTN",,None,"['Back pain', 'Dyspnoea exertional', 'Fatigue', 'Feeling hot', 'Headache', 'Joint swelling', 'Muscular weakness', 'Myalgia', 'Pain']",1,PFIZER\BIONTECH,IM 930582,TX,35.0,F,"5 hours after injection in left deltoid, my arm was was in pain/sore but just at injection site. Day 2 my arm was still in pain . Day 3 pain was gone and I felt ok. At day 8 injection site is itchy/ tender and I now have a welt. Day 9 itching is gone but now I have a welt and injection site is red and hot to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Vybriid 40 mg , one tab daily. Biotin 1,000 mg, Three tabs daily.",Depression,None,,None,"['Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Urticaria']",UNK,MODERNA,IM 930583,DC,37.0,F,"16 hours post shot, developed severe myalgias all over body, fever of 101, pain in my spine, back neck, most of my muscles. Nausea. Lightheaded, dizzy. Left neck, chest and armpit lymphadenopathy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,Multivitamin,,,,Solodyne,"['Axillary pain', 'Back pain', 'Dizziness', 'Lymphadenopathy', 'Myalgia', 'Nausea', 'Neck pain', 'Pyrexia', 'Spinal pain']",2,PFIZER\BIONTECH,IM 930584,UT,28.0,F,Reduced Breast Milk Production,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,UNK,Tylenol,,,,Penicillin Maxalt,['Lactation disorder'],1,MODERNA,IM 930585,IL,51.0,F,Day 9 swelling redness warmth on injection site 2 inch by 2 inch circle started dime size day one and has increased photo available,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/31/2020,30.0,OTH,Amitryptline 25 mg for migraines,None,Seasonal allergies asthma migraines,,Cephalaxin. Environmental Had similar reaction to ajovy shot for migraines,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 930586,TN,38.0,F,Moderate pain at the injection site for two days. Developed a rash on at injection site 9 days after. Itching comes and goes and is not severe itching. Very mild. The rash is about 3 inches by 2 inches in size.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,SEN,Vitamin D and C,None,None,,Penicillin,"['Injection site pain', 'Injection site rash', 'Pruritus']",1,MODERNA,SYR 930587,NH,28.0,F,"patient received the Moderna vaccine at 4:30 pm. Patient waited in observation lot for 15 minutes and proceeded to vacate the area. Patient returned to the site at 5:35 p.m. with hives on neck and tingle in throat. Pulse 92, 02 95%, and Blood pressure 142/92, and temp at 98.3. Patient has history of reaction to welbutrin. Patient administered 50 mg of Diphenhydramine HCL at 5:38 p.m. Pulse at 92, 02 99%, BP 134/84 and temp 98.4 at 6 p.m. Patient recovered and left in her friends vehicle at 6:53 p.m.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PUB,,,Asthma,,"latex, medications (welbutrin)","['Pharyngeal paraesthesia', 'Urticaria']",UNK,MODERNA,IM 930588,,52.0,M,"Patient had severe nausea/vertigo episode upon awakening on 1/8/21. Patient fainted and collapsed onto bathroom floor. He hit his head on the wall during the fall. Patient was found barely conscious by his wife right after the fall. Patient temperature, O2 sat and BP all within normal limits measured within 5 minutes of fall. Patient does have history of Meniere's disease x 5 years, but is well-controlled with medication and middle ear steroid injections. Patient has not had severe vertigo episode in 2+ years.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/08/2021,6.0,PHM,"Lisinopril, pravastatin, cyproheptadine, cetirizine, levothyroxine, azelastine nasal spray, budesonide nasal spray, Dupixent, glucosamine/chondroitin",,"Patient has history of Meniere's disease x 6 years, well-controlled by medication and past intra-ear treatments",,,"['Depressed level of consciousness', 'Head injury', 'Nausea', 'Syncope', 'Vertigo']",1,MODERNA,IM 930589,CO,33.0,F,"Within 5 minutes of administration felt tongue/throat tingling, then felt them starting to swell, making it difficult to swallow, flushing feeling, felt like I was getting tunnel vision (how you feel before you pass out). Reported symptoms to RN who administered shot. Given PO liquid benadryl and epi pen injection quickly- symptoms started to fade within 10-15 minutes, tongue tingly for a few hours. Monitored x 1 1/2 hours with frequent VS checks- HR/BP/SaO2 remained within normal limits",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Synthroid, Allegra, Multivitamin",,"Hypothyroidism, Asthma",,Seasonal allergies/animal dander,"['Dysphagia', 'Flushing', 'Paraesthesia oral', 'Pharyngeal paraesthesia', 'Pharyngeal swelling', 'Swollen tongue']",2,PFIZER\BIONTECH,IM 930590,KS,41.0,F,"The first day all I had was some soreness and by Wednesday it had faded. Thursday night 1/7 I started getting chills off and on. I felt like I couldn?t get warm. No fever. Took 800 mg of Ibuprofen l, went to bed. Still felt like I couldn?t get warm. At about 2:00 am I suddenly awoke to severe nausea and thought I was going to vomit, but it didn?t come up. Then, I felt like I was going to have diarrhea. No BM. Went back to bed eventually and continued to have chills and hot sweats back and forth. Nausea and stomach turning feeling off and on. No fever. Normal temperature. 1/8 stayed home from work due to nausea. Off and on during the day today and some light chills about 5 times so far. Some headache and possible shoulder stiffness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,PUB,"Ibuprofen, Arnica",None,None,,None,"['Abdominal discomfort', 'Chills', 'Feeling cold', 'Headache', 'Hyperhidrosis', 'Impaired work ability', 'Nausea', 'Pain']",1,MODERNA,SYR 930591,MI,34.0,F,Metallic taste in mouth and dry mouth that has persisted,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,Adderall,None,None,,Naproxen,"['Dry mouth', 'Dysgeusia']",1,MODERNA,IM 930592,CA,71.0,F,Mild headache Mild body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Headache', 'Pain']",1,PFIZER\BIONTECH,SYR 930593,WI,39.0,F,"No symptoms for about 12 hours. But woke up with arm sore, quite inflamed, red and hot at injection site. I don't get a reaction with other vaccines. My coworkers have had the same problem.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,Omeprazole Yasmin Cyclobenzaprine Duloxetine Sertraline Bisoprolol Bupropion Levothyroxine,Migraine,Migraines and tension headaches,,"Imitrex Cattails, pussywillows","['Inflammation', 'Injection site erythema', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 930594,NJ,52.0,F,"loss of conciousness , faint ,",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,WRK,"Metformin, Effexor xr , Zyprexa",unknown,"Diabetes , depression",,no,"['Loss of consciousness', 'Syncope']",1,MODERNA,IM 930595,MI,64.0,F,Stiff and sore neck 01/08/2021 10:00am to approx 2:00pm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Metformin, lisinopril, fish oil, citalopram, victoza",,"Diabetes, HBP",,,"['Musculoskeletal stiffness', 'Neck pain']",1,MODERNA, 930596,HI,38.0,M,"Officially I fainted, but I describe in detailed events of occurrence below. I was using my laptop doing some busy work while I waited the 15 minutes after taking the first shot of the Pfizer/BT Vaccine. I had the feeling that I could feel the vaccine coursing through my chest but I thought that was irrational and my mind and nerves playing tricks. I continued to work and let my mind wander for a moment. Next thing I know I was dreaming for a time and then I slowly awakened by the staff calling my name asking ""are you OK, do you know where you are?"" I was able to answer correctly, but my mind felt fuzzy/foggy where I felt as if I was running on automatic but my conscious mind was not in full control. At the time, It was hard to describe at the time how I was feeling as I was trying to note it down for future reference. All I could put down were simple words and I could not form full statements. Though I was very present in the moment. I can remember the name of the Nurses who I was talking to, and what we were talking about. They took me to be observed for about an hour longer. While I waited, I felt warm, especially in the areas of the back of my head and chest. I was not in any pain, but I was very thirsty. I was also getting pretty hot sitting there, but that may be because of the fact the ER Triage room has full glass wall in full sun. At the end of the hour the sun dropped lower in the sky I felt the normal cold refrigerated Hospital I am used to. I felt weak initially but by an hour I had regained most of my strength by the time the triage nurse took my vitals. After the physician looked over me and my report, they did not give me a reason of concern that would warrant keeping me and let me go home to rest.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,None,None,None,,None that I am aware of,"['Asthenia', 'Chest discomfort', 'Electrocardiogram', 'Feeling abnormal', 'Feeling hot', 'Syncope', 'Thirst']",1,PFIZER\BIONTECH,SYR 930597,FL,35.0,F,"Fever up to 102.7, tachycardia, joint pain, fatigue, and chills started approximately 20 hours after vaccine administration. Fever responded to 400 mg of ibuprofen. All other symptoms are persisting at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Sulfamethoxazole-trimethoprim and Zyrtec,Cutaneous abscess 1 week prior; SARS COVID-19 infection 7 weeks ago.,None,,None,"['Arthralgia', 'Chills', 'Fatigue', 'Pyrexia', 'Tachycardia']",1,MODERNA,IM 930598,NM,41.0,F,Within minutes rapid onset feeling of facial and neck flushing + rapid heartbeat + increased resp rate + shaking. Lasted approx 2 minutes. Subsided then returned a few minutes later for approx. 20 to 30 seconds then subsided. Left facility with no treatment. Onset of swollen tongue evidenced by scalloping approx. 1.5 to 2 hours after.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PHM,"Multivitamin+mineral, fish oil",None,None,,None,"['Flushing', 'Heart rate increased', 'Swollen tongue', 'Tremor']",1,MODERNA,IM 930599,OH,57.0,F,"headache, flushing, redness , warmth and hardness at injection site, weakness and extreme fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,5mg lisinopril,none,none,,none,"['Asthenia', 'Fatigue', 'Flushing', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site warmth']",1,MODERNA,IM 930600,SD,39.0,F,"8:45 am 12/24 - severe rash on my left hand; and wrist; a mild rash went to my arm, chest and back hairline and on my forehead. Benydryl - 25 mg. Went to ER after it spread at 11:00 am. Had another 25 mg benydryl and a pepsid 20 mg at ER. Rash lasted two days. Ended Dec. 26. It was also after I increased my seizure medicine on Monday 12/21. Received at 8:30 am today/8th - second dose of vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/24/2020,6.0,PVT,LAMOTRINE -150 MG (upped to this dose 2 times/day; was at 100 BID at time of vaccination; Kolonopin (clonASIPAN) - 1 mg tablet nightly; Trintellix - 10 mg 1 x/day; levoehyroxine - 75 mcgs 1x/day; iron 45 fg - 1x/day; Xertec 10 fg 1 x/day;,,"Asthma; seizures; depression, ptsd; hypothyroid disorder",,TAMIFLU,['Rash'],1,PFIZER\BIONTECH,IM 930601,OH,32.0,F,Migraine with nausea and vomiting that lasted approximately 7 hours and did not respond to typical treatment with Excedrin Extra Strength. Less severe events have been intermittent feeling of light-headedness that started an hour after vaccination and are still occurring 48+ hours later.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"ibuprofen, vitamin code raw prenatal multivitamin",none,Migraines- approximately 1 every 2-3 months,,none,"['Dizziness', 'Migraine', 'Nausea', 'Vomiting']",1,MODERNA,IM 930602,VT,44.0,F,"I had the worse headache I've ever had in my life, soreness in my arm. When I woke up in the morning it was pounding, spread to the right half of my head, nausea, photo sensitivity, vertigo. It took 36 to 48 hours before I could function. 48 to 72 hours later I had another headache with vertigo. I had complete vision loss in my left eye.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,UNK,,No,,,"I am allergic to compazene, tetracycline","['Blindness unilateral', 'Headache', 'Nausea', 'Pain in extremity', 'Photosensitivity reaction', 'Vertigo']",UNK,PFIZER\BIONTECH,IM 930603,TX,50.0,F,employee felt near syncope[al episode post vaccine administration,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,unk,unk,unk,,unk,"['Blood glucose fluctuation', 'Presyncope']",2,PFIZER\BIONTECH,IM 930604,FL,70.0,F,"Dizziness, throat and lung discomfort, swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,OTH,"Eliquis, crestor, vitamins D,C and calcium",None,"Intermittent afib, bradycardia, post-prandial hypoglycemia.",,"Shellfish, medical dye, iodine, barium and some commercial personal care products.","['Chest discomfort', 'Dizziness', 'Oropharyngeal discomfort', 'Swelling']",UNK,MODERNA,SYR 930605,CA,34.0,F,"not described in report, vitals: - BP 171/108, HR 87, 100% O2 - BP 171/127, 100% O2",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,patient could not remember,no,hypertension,,"baclofen, statins",['Unevaluable event'],2,PFIZER\BIONTECH,IM 930607,MO,36.0,F,Patient received first dose on 12/23/20. Patient received the second dose on 1/8/21. This date was out of the recommended 21 day revaccination (+/- 4).,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,WRK,,,,,,['Incorrect route of product administration'],2,PFIZER\BIONTECH,IM 930608,DE,29.0,F,Patient described Rash and itching approximately 2.5 hr after she received the pfizer covid -19 vaccine first dose. She received 1 dose of Diphenhydramine 25mg po. Few minutes later she complained difficulty sallowing and given Epinephrine 0.3mg IM and EMT was called in. She was transported to ER by EMTs,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,OTH,,,,,,"['Dysphagia', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 930609,OR,23.0,F,"The patient experienced diffuse itching after vaccination; was cleared to leave vaccine clinic, but persistent symptoms led her to seek care at ED. She was treated with Prednisone, hydroxyzine, famotidine. PMHx: depression and anxiety; no current meds; Allergies: Hydrocodone and Oxycodone which cause pruritis.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/26/2020,0.0,PVT,none,none,depression and anxiety,,Allergies: Hydrocodone and Oxycodone which cause pruritis,['Pruritus'],1,PFIZER\BIONTECH,IM 930610,NC,28.0,F,I RECIEVED THE VACCINE ON 12/29 @ 0900. THAT AFTERNOON I DEVELOPED A HEADACHE AND EXTREME FATIGUE. THE NEXT DAY 12/30 I DEVELOPED REDNESS AT INJECTION SITE AND STARTED TO BECOME HOT AND ITCHY. IT IS NOW 01/08/2021 AND I AM STILL BATTLING HEADACHE AND INJECTION SITE SORENESS.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"Cetirizine, Prilosec",,,,Allergy to sulfa drugs,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 930611,MA,71.0,M,"Developed hypercapnic respiratory failure, CHF exacerbation - readmitted to Hospital. In ICU with BIPAP",Not Reported,,Yes,Yes,,Not Reported,N,01/06/2021,01/07/2021,1.0,SEN,"Albuterol, metoprolol, fish oil, apixiban, insulin","Advanced diastolic heart failure and CKD. Returned from hospitalization one week prior for CHF exacerbation treated with BIPAP, IV diuresis","oxygen dependent COPD, type II DM, diastolic CHF, stage IV renal failure, personality disorder",,"statin, PCN","['Bilevel positive airway pressure', 'Cardiac failure congestive', 'Condition aggravated', 'Intensive care', 'Respiratory failure']",UNK,MODERNA,IM 930612,,29.0,F,"red skin, itching, injection site pain, dizzines. Given 25mg PO benadryl, and then 25mg more benadryl after symptoms continued. After the second dose of benadryl, s/s subsided enough for the staff member to go home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,SEN,,,,,,"['Dizziness', 'Erythema', 'Injection site pain', 'Pruritus']",1,PFIZER\BIONTECH,IM 930613,AK,37.0,F,"Major allergic reaction, became lightheaded with a near syncopal episode. Patient complained of tightness and itchiness in her throat.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,MIL,,,,,"Potatoes, bupropion, morphine,","['Dizziness', 'Hypersensitivity', 'Presyncope', 'Throat irritation', 'Throat tightness']",1,MODERNA,IM 930614,,61.0,M,Pt has nonresponsive episode on 12/30/20 30 minutes after receiving his 1st injection of moderna covid vaccine. Became responsive 3 minutes later. Pt current patient at LTC facility hx of CVA and pseudobuldar palsy,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,SEN,,,,,,['Unresponsive to stimuli'],1,MODERNA,IM 930615,MI,49.0,F,01/08 sent email to cancel the second dose. I called her and she states after the first dose after about 1.5 hours started getting tachy and palpations for about 6 hours following her shot. She states her resting HR was HR 130 for about an hour but she just sat and waited it out. She denies going to ER or calling she stated she had this happen about 6 years ago and just waitied it out. She stayed and worked stating she just did inservices and after about 6 hours felt better before she states she felt fine the next day except for sore arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,unknown,denied,unknown,,NKDA,"['Pain in extremity', 'Palpitations', 'Tachycardia']",1,PFIZER\BIONTECH,IM 930616,MN,35.0,M,"Moderna COVID-19 Vaccine EUA Injection site pain after injection. Upon waking up this morning, it was very difficult to get out of bed. My entire body felt stiff, and sore. I had a severe headache and get nauseous. Felt warm, temp was only 99. I made it to the couch where my day was spent sleeping. Very fatigued, very sore, and headache remains. Not able to keep food/liquids down.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,UNK,Men?s daily vitamin,None.,None,,Shellfish,"['Fatigue', 'Feeling hot', 'Headache', 'Injection site pain', 'Mobility decreased', 'Musculoskeletal stiffness', 'Nausea', 'Pain', 'Somnolence', 'Vomiting']",1,MODERNA,IM 930617,FL,45.0,F,"PT HAD A VASOVAGAL SYNCOPE EPISODE: ( SWEATING, NAUSEA, AND BLOOD PRESSURE DROPPING). PT WAS LAYED ON THE FLOOR IN A SUSPINE POSITIION WITH FEET ELEVATED. PT WAS PLACED ON A BLOOD PRESSURE MONITORING MACHINE. COLD COMPRESSIONS WERE APPLIED TO THE PATIENT'S BODY. PT WAS GIVEN A FEW CRACKERS AND SODA TO INCREASE BLOOD SUGAR. WITHIN MINUTES THE PT BLOOD PRESSURE BEGAN TO RISE AND PT FELT FINE. PT WANTED TO DRIVE HOME AND WAS ADVISED NOT TO DRIVE. PT CALLED FOR HER PARENTS TO COME AND PICK HER UP.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,NONE/ UNKNOWN,NONE/UNKNOWN,NONE/UNKNOWN,,CODEINE,"['Blood pressure decreased', 'Blood pressure increased', 'Hyperhidrosis', 'Nausea', 'Syncope']",2,PFIZER\BIONTECH,ID 930618,OK,53.0,F,"Upper left arm at injection site red, swollen, warm and pain. Area swollen approximately 7cm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Protonix Plavix Celexa Tylenol,None,Anemia History of CVA,,None,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",UNK,PFIZER\BIONTECH,IM 930619,NJ,30.0,U,"Soreness in arm, day 3-4 was extremely fatigued, I could not get up off the couch. Then I developed a runny nose and sore throat. I went and got tested for COVID and it was negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/23/2020,2.0,WRK,Omeprazole,,Reflux,,,"['Fatigue', 'Oropharyngeal pain', 'Pain in extremity', 'Rhinorrhoea', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 930620,OH,31.0,F,"Rash developed on chest. Red, not raised, slightly itchy but not severe. A flushed red rash. Took 25mg of chewable Benadryl and it subsided. 2 hours later right ear became red, hot, and itchy. A few raised bumps appeared on top of ear, slightly itchy. Sore arm at injection site but no other complaints at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,Birth Control Pill (Lo Estrin),None,None,,No known allergies,"['Erythema', 'Flushing', 'Injection site pain', 'Pruritus', 'Rash', 'Rash erythematous', 'Rash papular', 'Skin warm']",1,MODERNA,IM 930621,IL,58.0,F,"Difficulty swallowing. Sensation of lip swelling. Immediate Care response activated. IV Benadryl, Solumedrol and Pepcid given. Patient taken to Care Center for observation and further care.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Dysphagia', 'Lip swelling']",2,PFIZER\BIONTECH,IM 930623,CA,19.0,F,"Patient reported no adverse event or allergies at pre-screening so received vaccine around 1:55pm and around 3.25pm patient reported of headache, SOB, faster heart rate, having to stop in middle of sentence, chest hurting breathing in . Emergency services was called and patient was assessed while waiting for emergency services to arrive. At 3.39pm BP 125/80 mmHg, 84 bpm and oxygen stat. 97%, again at 3.42pm oxygen stat. 98% and pulse 81bpm",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,SEN,,NONE,NONE,,NONE,"['Chest pain', 'Dyspnoea', 'Headache', 'Heart rate increased']",1,PFIZER\BIONTECH,IM 930624,WI,25.0,F,"I received my shot at 2:30 pm. A few hours later my arm was very painful. I could hardly move my arm and it kept me up all night. Around 4 am I had a sore throat and a stuffy nose. At about 7 am I had a headache, fever of 37.6 Celsius, chills, and horrible body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Vitamin D, birth control",No,"Asthma, scoliosis with back/neck/hip pain",Very sore arm after anthrax shot (for work purposes). I forgot all of the adverse reactions (this was in 2019) but my symptoms g,No,"['Chills', 'Headache', 'Mobility decreased', 'Nasal congestion', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Pyrexia', 'Sleep disorder']",1,MODERNA,SYR 930625,MI,60.0,F,"First, let me say that I had a diagnosed case of Coronavirus in April of 2020 last year. I woke up about 12 hours - at about 3 or 3:30am - after receiving the vaccine to my teeth chattering and feeling like I was freezing. It felt about the same as it did when I have Coronavirus before. My head was hurting like a tension headache, I had a slight buzz in my ears, my neck, shoulders, back all hurt (body aches). I felt pressure in my chest but unlike when I had the virus, I could still breathe. Eventually instead of freezing, I got hot and my temperature went to 101.9. I checked it several times with 3 different thermometers. I became dehydrated quickly which I realized because I kept going to the bathroom. My niece brought me Gatorade which helped. I also took Naprxin 500mg. On Thursday morning I felt better. Now what remains to oday, Friday, 1/8 is a sore arm that feels HOT to the touch at the injection site. I admit I am not looking forward to Moderna shot #2. It gave me flashbacks of the Virus I suffered through for a month before being able to get a test and another month afterward from March 6 when I think I contracted it through May 15 when I tested negative. I wish I understood why this happened to me and if it will happen again. I am reporting this because my Test was arraigned via my job and my CIO said I should. A friend who I happened to see at the test site who tested a few patients after me has zero negative effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PHM,Lisinopril 2.5mg I took it before the vaccine. I didn?t take other meds but I also take Metformin and vitamin D,None,High Blood Pressure Pre-diabetic,,None I am aware of,"['Arthralgia', 'Back pain', 'Chest discomfort', 'Chills', 'Dehydration', 'Dyspnoea', 'Feeling cold', 'Feeling hot', 'Headache', 'Injection site pain', 'Injection site warmth', 'Neck pain', 'Pyrexia', 'Tension headache', 'Tinnitus']",UNK,MODERNA, 930626,MI,26.0,F,"Fatigue, chills, low grade fever for 36 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,Birth control,None,None,,None,"['Chills', 'Fatigue', 'Pyrexia']",UNK,MODERNA, 930627,NY,22.0,F,"Immediately after the vaccine a large welt formed at the site of vaccination. There also was a red rash that appeared around the site. Patient reported she didn't feel any pain. After about 20 minutes the swelling went down. She reported still not feeling any pain at the site. We observed patient for 30 minutes. Swelling went down, skin was not hot or flushed at the site. Patient was instructed to continue to monitor and would follow up with emergency room or primary care if she felt it was necessary. She was not given any medications while on site. She continued to feel fine with no trouble breathing, no dizziness, or any other complaints.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PUB,Unknown,,,,None listed,"['Immediate post-injection reaction', 'Injection site rash', 'Rash erythematous', 'Urticaria']",1,MODERNA,IM 930628,OR,50.0,F,Had altered mental status after vaccination. Potassium was low at 2.6; Lactate elevated at 5.7. Head CT was normal. PMHx: Diverticulitis and GERD. She has history of Airway constriction and Hives with lo dose aspirin,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,None known,,? GERD (gastroesophageal reflux disease) � ? Diverticulitis,,"? Covid-19 Vacc,Mrna(Pfizer)(Pf) Anaphylaxis ? Asprin Ec Low Dose [Aspirin] Airway Constriction and Hives","['Computerised tomogram head', 'Confusional state']",1,PFIZER\BIONTECH,IM 930629,NC,56.0,F,"Fatigue, body aches, cellulitis at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/06/2021,5.0,MIL,"Lipitor, Prilosec, Telmisartin, Vit D, Zyrtec, Flonase",,"HTN, HIGH CHOLESTEROL, GERD, DM",,Lactose,"['Fatigue', 'Injection site cellulitis', 'Pain']",2,PFIZER\BIONTECH,IM 930630,WA,57.0,F,"10 days after the vaccine injection, I developed an itchy, red, hard and hot spot at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/06/2021,9.0,PUB,Gabapebtin Copaxone HCTZ Fiber Vitamin D Womens Vitamins Zolpidem Metroprolol Pravastatin Duloxetine,None,Mulitple Sclerosis High Blood Pressure High Cholesterol Depression,,Latex Penicillin Neopmycin Band aid glue,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,MODERNA,IM 930631,IN,40.0,M,"Large lump at injections sight, size approximately 9cm round, tender to touch first day after injection, 2nd day area itchy and much less tender.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,SEN,"Tramadol, Duragesic",None,Pain,,Sulfa antibiotics,"['Injection site mass', 'Injection site pain', 'Injection site pruritus']",UNK,MODERNA,IM 930632,WA,34.0,F,Abscess at site of vaccination which appeared about one week after. Right shoulder/deltoid.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,01/08/2021,38.0,MIL,Hydroxyzine.,Subclinical hypothyroidism,Morbid obesity,,Lidocaine Cinnamon All anesthetics,['Injection site abscess'],UNK,MODERNA, 930634,PA,25.0,F,"12 hours post-dose woke up with chills, fever, headache, full body aches, injection arm swollen, red, and painful",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"Sertraline 200mg, bupropion 150mg XL",None,"Migraines, depression, anxiety",,None,"['Chills', 'Erythema', 'Headache', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930635,AL,38.0,F,Right axillary lymph node swollen and very painful,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,PVT,None,None,None,,Sulfa antibiotics,"['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,SYR 930636,NY,34.0,M,"Axillary lymphadenopathy - left side, starting around 24-36 hours after the second dose and continuing beyond at least 72 hours (current time). Some improvement in swelling with naproxen. Mild pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Lymphadenopathy', 'Pain', 'Swelling']",2,PFIZER\BIONTECH,IM 930637,NY,38.0,F,"Shaking chills, lasting 2-3 hours, onset about 10 hours after administration with associated fever Also had localized soreness at site of admin that began 4-6 hours after admin, and is still a little present 2 days post admin, but improving",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Lamisil, Quercetin, Elderberry, Zinc",,Alopecia Areata,Local soreness after tetanus and annual flu vacccines,Anthralin,"['Chills', 'Injection site pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930638,FL,68.0,M,"As a physician for over 40 years I tend not to pay attention to my symptoms if I develop the flu or a virus. I just put up with it I received a COVID-19 Moderna vaccination on January 7. Approximately 12 hours after I started to develop adverse reactions. These of Inc. severe myalgias, fever to 102, chills, headache, severe fatigue (to the point where it is difficult to get out of bed) Not much reaction at the injection site. Hydrogen saturation in the 90s and pulse in the 70s. I did contract Covid in March 2020. I was alone for two weeks. However no respiratory problems or hospitalization. I?m currently speculating that having had covered in March has resulted in a significant immune reaction from this vaccine. I would appreciate your input on this. Can I expect this again when I receive my second vaccine in one month? Thank you",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PUB,Syntheoid,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Mobility decreased', 'Myalgia', 'Pyrexia']",UNK,MODERNA, 930639,CO,32.0,F,"Numb face, bilateral arm numbness, difficulty breathing",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,Unknown,Unknown,,NKDA,"['Dyspnoea', 'Hypoaesthesia']",2,PFIZER\BIONTECH,IM 930640,CO,27.0,F,"Swelling, redness and itchiness around injection site one week after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 930641,FL,72.0,F,"Woke up at 3 am, temperature of 99.6, body aches, joint pain, brain fog and fatigue. Starting taking Advil and Tylenol every six hours. No respiratory issues.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Lyrica 100mg, Cymbalta 60mg, Tramadol 50mg, Ambien 5mg",no,"Radiation Enteritis, Lymphadema",flu vaccine had symptoms of flu,no,"['Arthralgia', 'Body temperature increased', 'Fatigue', 'Feeling abnormal', 'Pain']",1,MODERNA,IM 930642,TX,31.0,F,"Large lump 24 hrs after injection, headache, body ache.... Lump present for 5 days the disappeared ( i thought all was well no reaction. Jan. 7,2021 Then overnight the lump reappeared and arm is itchy really bad, site hot to touch arm swollen. Lump softball size, painful when bumped",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PHM,Ibuprofen 600mg,,Sciatica Asthma,,"Milk,","['Headache', 'Injection site mass', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pain']",1,MODERNA,SYR 930643,AZ,44.0,F,"High temp 1.5 days after shot, severe chills, body aches headaches, Symptoms are getting better but I?m into day 3 and still have a temp with moderate headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/01/2021,01/06/2021,5.0,OTH,,,,,"Sulfa, penicillin","['Chills', 'Headache', 'Pain', 'Pyrexia']",2,MODERNA,IM 930644,CA,25.0,F,"Upon administering vaccine at 9:50am, needle came detached from syringe. Was able to administer some of dose before syringe became completely detached, but at least half of dose (0.25ml) spilled out and was not injected. Consulted with MD, in-clinic. Per MD, administered 0.25ml (half dose) of Moderna Covid-19 vaccine 4 hours after 1st dose attempt (at 1:50pm).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,unknown,none,unknown,,unknown,"['Immunisation', 'Needle issue', 'Syringe issue', 'Underdose']",1,MODERNA,IM 930645,WA,35.0,F,"Roughly 4-5 minutes following my vaccination I felt a rush of lightheadedness, tension in my neck, difficulty obtaining a deep breath, flushed and sweating. My vitals were obtained by on on-site medic HR/BP were elevated and SO2 had dropped. I was under direct supervision of a medic for roughly 45 mins, vitals were taken again half way through and had normalized but were still high in comparison to my usual. The light headed feeling and flushed feeling did not subside and I was unable to drive myself home, I had to leave my vehicle and arrange a ride from my husband. Since returning home I have battled sweats, chills, increased pain in my left shoulder, increased headache, body aches, tension in my neck and shoulders, and diarrhea. It has been 24 hours and an intense headache/neck ache still remains, some fluctuating warm/cold body temps, and diarrhea are still persisting.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,,,,,Diary sensitivity,"['Blood pressure increased', 'Chills', 'Diarrhoea', 'Dizziness', 'Dyspnoea', 'Feeling of body temperature change', 'Flushing', 'Headache', 'Heart rate increased', 'Hyperhidrosis', 'Injection site pain', 'Joint contracture', 'Muscle tightness', 'Neck pain', 'Oxygen saturation decreased', 'Pain']",1,MODERNA,IM 930646,KY,42.0,F,"I woke up on 1/8/20 at 2:00 am with my left arm hurting badly. I felt feverish, chilled, with a headache and full body muscles aches. I checked my temperature at 7am and it was 100.5 oral. I could barely get out of bed all day. My temperature peaked at 101 despite taking 400mg of Ibuprofen at 9am. It is currently 8 pm on 1/8/20 and I still have a fever, muscle aches, headache and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,None,"Possibly, I received my first covid vaccine on 12/17/20 and developed a very sore arm and tiredness on 12/18/20. These symptoms lasted 2 days. However, on 12/23/20 I became sick with a low grade fever of 99.4, scratchy throat, head congestion, headache, and fatigue. I had a rapid test for covid on 12/24/20 and it was negative. I felt well on 12/26/20.",None,,"Penicillin, sulfa, doxycycline","['Chills', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative', 'Similar reaction on previous exposure to drug']",2,PFIZER\BIONTECH,IM 930647,MA,41.0,F,"I was sitting in observation at minute 10 or 11. All of the sudden I felt as though my heart was racing, I developed numbness and tingling of both my arms as well as my legs. I then develop tingling and numbness of my face. I felt dizzy and as though I was going to pass out. I then sought help",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,Wellbutrin and lexapro,None,None,,None,"['Dizziness', 'Electrocardiogram', 'Hypoaesthesia', 'Palpitations', 'Paraesthesia', 'Pregnancy test']",1,MODERNA,IM 930648,NY,32.0,M,severe injection site soreness (left arm) about 12-16 hours post moderna covid vaccine dose 1. Severe tension headaches daily on days 2-5 post vaccine that could not be linked to other causes,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,omperazole 40mg once daily,none,gastroesophageal reflux,,no known drug allergies.,"['Injection site pain', 'Tension headache']",1,MODERNA,IM 930649,IN,22.0,F,"Body aches, joint pain, fatigue, axillary lymph node swelling and pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,UNK,"Paxil, apri",no,POTS,,no,"['Arthralgia', 'Axillary pain', 'Fatigue', 'Lymphadenopathy', 'Pain']",2,PFIZER\BIONTECH,IM 930650,UT,62.0,F,"At 2 am, I woke up to severe chills and body aches, and horrible migraine. I checked my temperature and it was 100.7. It continued to climb to 102.8. I took Tylenol and Ibuprofen all night and all day and could not get relief. I missed a day of work because of this. I am still with fever as of 5:55 pm and the body aches and migraine. This was not explained to me. I feel like I did when I had Corona on the worst days. I am really praying that this ends so that I can go back to work tomorrow. I thought that someone was supposed to call and check on us each day....",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PUB,"Prozac, Topamax, Ropinirol, Trulicity",None,Type 2 Diabetes,,None,"['Chills', 'Impaired work ability', 'Migraine', 'Pain', 'Pyrexia']",1,MODERNA,SYR 930651,CA,32.0,U,"antiseptic taste in mouth, numb lips, resolved soon after.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,"['Hypoaesthesia oral', 'Taste disorder']",1,MODERNA,IM 930652,TN,50.0,F,Mild itching that started within 20 minutes of injection that I thought was a result of my sweater material. But itching increased over a couple hours of time even after changing clothes. No rash on body. Just itching all over. Benadryl helped calm itching and it finally started subsiding around 4 hours later.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,"Bystolic, Junel Fe, Vyvanse, Trazadone, Ibuprofen",None,High blood pressure,,Shellfish,['Pruritus'],UNK,PFIZER\BIONTECH,IM 930653,AK,37.0,F,"Season received the Pfizer-BioNTech COVID 19 vaccine today at 8:30 and scheduled for 30 minute wait time because of prior history of anaphylaxis (non-vaccine). Within a few minutes she developed light-headedness and dizziness, these symptoms continued to worsen so she notified our nurse who was observing post-vaccine patients. She was promptly wheeled to our anaphylaxis room at 8:50 and placed in semi-Trendelenburg position. In addition to light-headedness and dizziness. she reported mild neck tightness and throat fullness. She had facial flushing and conjunctival injection with some tearing. She was monitored for Vital Signs and Oxygen Saturation. Within 20 minutes her symptoms progressed to chest heaviness, increased effort to take a breath and shortness of breath. She was mildly tachycardic with HR 96, though did not become hypotensive, B/P was 140/92. She had no gastrointestinal symptoms. She was anxious and ""did not feel right"", but did not report ""impending doom"". At 9:05 Epinephrine 1:1000, 0.3mL was administered IM, upper-outer thigh. Symptoms began improving within 8 to 10 minutes and were mostly gone by 9:20. At 9:17 she was given Diphenhydramine Solution 25mg, Famotidine 20mg, Prednisone 20mg. Her vital signs and Oxygen Saturation remained stable. (see flow sheet) Patient was monitored by an RN for 2 hours in our anaphylaxis room, on monitors, full crash cart present.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Xopenex Ipratropium Bromide nasal Pantoprazole Synthroid Clobetasol B12 injection Epi-Pen,none,Sjogren's Disease Raynaud's Syndrome HLA-B27 positive Hypertension Tachycardia Asthma Perennial Allergic Rhinitis (dust mite),,Wasp Venom (sting- anaphylaxis) Morphine (rash) Demerol (rash) Levaquin (muscle pain) Macrobid (rash),"['Anxiety', 'Chest discomfort', 'Conjunctival hyperaemia', 'Dizziness', 'Dyspnoea', 'Flushing', 'Muscle tightness', 'Tachycardia', 'Throat tightness', 'Tryptase']",1,PFIZER\BIONTECH,IM 930654,WI,48.0,F,"1/29/20: Mild arm pain at 0030, applied cold pack and took ibuprofen. At 0445, woke up with rigors, uncontrolled shaking (not just chills) and temp was 100.4. Re-dosed with ibuprofen 600 mg (had taken 600 mg 4 hrs earlier). Three hours later fever to 102.6, and fever persisted for 2+days. Fever persisted for the first 36 hrs despite fever reducers. Extreme muscle aches (as bad/worse than when ill with Covid), headache, fatigue, joint pain, unable to get out of bed for 48+ hrs. See V-safe information as well for details. 12/30/20: to walk in/urgent care as recommended by my employer for Covid/influenza testing and tests all neg. Missed 3 days of work, unpaid. 1/2/2021: left arm/shoulder pain/joint pain and swelling, continued fatigue/headache but symptoms improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/01/2020,,WRK,"None Ibuprofen (600 mg) was taken that afternoon/eve, and 4 hrs before fever started (Ambien as needed hs, Gabapentin bid headaches/menopause s/p shingles 18 mos ago)",None,"Headaches, but nothing that affects me daily.",,None,"['Arthralgia', 'Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Impaired work ability', 'Influenza A virus test negative', 'Influenza B virus test', 'Injection site pain', 'Injection site swelling', 'Joint swelling', 'Mobility decreased', 'Myalgia', 'Pain in extremity', 'SARS-CoV-2 test negative', 'Tremor']",1,MODERNA,IM 930655,IN,35.0,F,"Upset stomache, nausea, bloating, insomnia, extreme body and joint pain, sensitivity to light, chest and back pain, head ache, dizziness. Spoke to Doctor and suggested rest, pushing fluids, and switching between Tylenol and ibuprofen every 6 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"Synthroid, loratadine, omeprazole, venlafaxine, vitamin c, probiotic, elderberry",,"Hypothyroidism, small fiber neuropathy, chronic migraines",,"Amoxicillin, vancomycin, erythromycin, keflex","['Abdominal discomfort', 'Abdominal distension', 'Arthralgia', 'Back pain', 'Chest pain', 'Dizziness', 'Headache', 'Insomnia', 'Nausea', 'Pain', 'Photophobia']",UNK,MODERNA,SYR 930656,,21.0,F,headache,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,WRK,trintellix zoloft trazodone prn for sleep buspar bid,,,,penicillin,['Headache'],1,MODERNA,IM 930657,CO,36.0,F,"10 minutes after injection given, member reported that she felt swelling in throat and mouth. Was given 1 dose of epi 0.3mg IM in left thigh. Also given diphenhydramine 50mg PO. No worsening in symptoms but no improvement either. Dr recommended patient be sent to ER for further observation. Patient transported to ER .",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Mouth swelling', 'Pharyngeal swelling']",1,MODERNA,IM 930658,MT,49.0,M,body aches and HA started at noon,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Headache', 'Pain']",2,PFIZER\BIONTECH,IM 930659,IN,26.0,F,"Flu-like symptoms (severe body aches, fever, headache, fatigue)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,Sertraline,None,None,,None,"['Fatigue', 'Headache', 'Influenza like illness', 'Pain', 'Pyrexia']",1,MODERNA,IM 930660,NY,43.0,F,"Chills, body shaking feeling very cold in hands, feet and shoulders /neck from 8pm til 11pm and then very warm. Restless due to pain throughout body and poor sleep Vs unable to sleep. Woke at 2:30 am to call into work. Checked temp at 101,6 (temps throughout Covid no higher than 98.5). Very tired and weak throughout 1/5/21 with lying in bed except to use bathroom abs brush teeth at 6pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Levothyroxine, elderberry gummies",Cough and severe headache 12/24/20 with positive Covid test 12/25/20,"Celiacs, hypothyroidism, sjrogrens",,Gluten/Celiacs,"['Asthenia', 'Body temperature increased', 'Chills', 'Fatigue', 'Feeling of body temperature change', 'Impaired work ability', 'Insomnia', 'Pain', 'Peripheral coldness', 'Poor quality sleep', 'Restlessness', 'Tremor']",1,MODERNA,IM 930662,WA,47.0,F,"Reported itchy throat, tongue, face apprx 10 mins after vaccine. Later that night she had all over body itching with no rash and mouth swelling, eye swelling. No SOB, or difficulty swallowing.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,unknown,,,,Gluten meal,"['Pruritus', 'Throat irritation', 'Tongue pruritus']",1,PFIZER\BIONTECH,IM 930663,MA,49.0,F,"With seconds after injection, at about 5:15 pm, there was a rush to my head. My nose became immediately and intensely congested to the point there was pressure, I felt heated and as I communicated that I may be having a reaction my throat started to swell. Then it suddenly released. A heat ban moved down my body to my abdomen. I waited for about 20-25 minutes and felt fine. Then about 45 minutes later, I experienced tingling in my lips and very mild congestion. The tingling and mild congestion would perhaps come on and subside with less intensity over the next hour. Very mild congestion continued on and off until the next afternoon.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,None,None,None,,"Egg and peppers intolerance, pet allergies.","['Feeling hot', 'Nasal congestion', 'Paraesthesia oral']",1,MODERNA,SYR 930664,TX,26.0,F,"DPH (after the Lot number); I started with a very severe pounding tension headache - 6:00 am; very severe fatigue; very severe arm pain at injection site. And then unable to complete daily functions: do to headache; suffered from headache - took one gram tylenol to address a low grade fever that day and the headache, too. fever subsided with tylenol. Headache was relentless; I tried 600 mg of ibuprofen as well to treat headache with no success; Started to suffer severe pain; couldn't open eyes from pressure of headache. Went to ER due to never having such a severe headache before. Tests did not show pathology that would cause headache. Was given one liter of IV fluids. Was given 25 mg of benydryl ; 10 mg of compazine. Along with toradol. And 20 meq of potassium. Discharged home with two prescription migraine medications. Resolution of symptoms by 27th. COVID Test was negative result.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,no,headache,headaches,,no,"['Eyelid function disorder', 'Fatigue', 'Head discomfort', 'Headache', 'Injection site pain', 'Loss of personal independence in daily activities', 'Pyrexia', 'Tension headache']",1,MODERNA,IM 930665,KY,45.0,F,Rash present at the top of the neck that appeared 30 minutes after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,SEN,,,,,,['Rash'],1,PFIZER\BIONTECH,IM 930666,CT,29.0,F,left upper arm cellulitis,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/07/2021,8.0,PVT,,,,,,['Cellulitis'],1,MODERNA, 930667,PA,53.0,F,"1/7/2020 in am- injection site size of a quarter, red, hot to touch, itchy, painful. Upper lip itchy for 3 hours. Late afternoon developed joint pain, muscle aches, fatigue, chills, headache, nausea. 1/8/2020 3am injection site size of 50 cent piece , red, hot to touch, itchy, painful , small bumps on upper arm and upper chest. Chills, headache, joint pain, muscle aches, fatigue, nausea and diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,Levothyroxine Zoloft Protonix Pravachol Lumigan Eye Drop,Covid 19 Swab taken 11/23/2020,Thyroid disease High Cholesterol Glaucoma Concussion,"Influenza vaccine. Injection site becomes red, hot, itchy",Epinephrine Red Dye Strawberry,"['Arthralgia', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Lip pruritus', 'Myalgia', 'Nausea', 'Rash']",1,MODERNA,IM 930668,CA,43.0,F,"This morning Friday 1/8/21 pt was given injection at 0912. At about 0930 pt C/O diaphoresis, lightheadness. Water was offered. BP taken manually in 80s. 911 was called. Pt suffering substernal pain. A/OX4 no fainting. Paramedics arrived at 0940, assessed pt and EKG performed. Paramedics encouraged for pt to go to her hospital, Pt declined and exited clinic on her own.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,unknown,none declared,none declared,,"unknown , pt denied any hx of anaphylaxis to anything","['Chest pain', 'Dizziness', 'Electrocardiogram', 'Hyperhidrosis']",1,MODERNA,IM 930669,AR,56.0,M,"patient begin to feel bad that night was admitted into hospital sometime in the next couple of days for dehydration, patient discharged home and then readmitted to hospital for positive covid testing after feeling very ill.",Not Reported,,Not Reported,Yes,3.0,Not Reported,,12/17/2020,12/17/2020,0.0,PVT,none reported,none reported,none reported,,none reported,"['Dehydration', 'Feeling abnormal', 'Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 930670,NY,48.0,F,The patient reported shortness of breast and difficulty breathing. The patient's husband stated that he witnessed the patient having a seizure. Patient advised to call EMS. EMS took the patient to hospital. The patient was stabilized after receiving emergency treatment.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Vitamin-D, Levathyroxine, and a Iron supplement",No,No,,Penicillian,"['Dyspnoea', 'Seizure']",1,PFIZER\BIONTECH,IM 930671,PA,51.0,F,"Tinnitus, generalized fatigue, muscle- specifically mid back, achiness, neck muscle/trapezius achiness, soreness at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Zyrtec,None,None,Injection site soreness,"Kefkex, amoxicillin, latex","['Back pain', 'Fatigue', 'Injection site pain', 'Pain', 'Tinnitus']",1,PFIZER\BIONTECH,IM 930673,CO,48.0,F,"1 week after injection I developed well demarcated, red, hot, painful induration at the injection that traveled slightly down the arm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,WRK,"levothyroxine, Mirecette, omeprazole, Ritalin LA, Zyrem, vitamin C and D and B12",None,"Hypothyroidism, narcolepsy, GERD, PCOS",,NKDA,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 930674,WI,38.0,F,"Light headed, dizziness, pain in left arm from shoulder to elbow, fluzzy and numb feeling on roof of mouth, sob, constricted throat, altered sense of taste. Episode lasted for about 30 minutes. I sat and rested, focusing on my breathing and not panicking. I did not seek medical attention.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,Zyrtec and Conception,None,Asthma,,Sulfa and Allegra,"['Dizziness', 'Dyspnoea', 'Hypoaesthesia oral', 'Taste disorder', 'Throat tightness']",1,PFIZER\BIONTECH,IM 930675,WA,65.0,F,"awakened at 0500 the following morning with a blinding migraine and nausea. Prior to that there were no sequelae. No redness or swelling at the injection site; mild generalized muscle aches. Took ibuprofen 600 mg tid for 36 hours. Additional -- difficulty concentrating, some word finding issues and fatigue. Symptoms resolved after 52 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,"fluoxetine 30 mg, caltrate bid, salmon oil","depression, chronic post nasal drip",none,,NKA,"['Aphasia', 'Disturbance in attention', 'Fatigue', 'Migraine', 'Myalgia', 'Nausea']",1,MODERNA,IM 930676,CA,36.0,F,12/23/2020 I started expecting the congestion on 12/25/2020 I lost taste and smell & I felt out of breath and also had diarrhea. 12/26/2020 a doctor called me I express my symptoms he ordered a test for covid & I tested positive. On Saturday 01/02/2020 visited the ER to get help to breath,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/24/2020,5.0,WRK,Wellbrutin Celexa Adderall,No,migraines depression and anxiety,,No,"['Ageusia', 'Anosmia', 'COVID-19', 'Diarrhoea', 'Dyspnoea', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,IM 930677,CA,39.0,F,"?Moderna COVID?19 Vaccine EUA? On day 1 I felt as though I might faint when sitting down. On day 2 I am having significant arm pain, low grade fever, sore throat and I am just not hungry. I feel nauseated when I think of food. I am just exhausted. My blood type is O positive if that matters",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,None,None,High Cholesterol,,None,"['Decreased appetite', 'Dizziness', 'Fatigue', 'Nausea', 'Oropharyngeal pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 930678,FL,45.0,F,"11 hours after vaccination (12 midnight), I noticed a small redness on the injection site. Right after I saw that, I took a shower and minutes after a shower I developed red itchy rash all over my arms and legs. Then my abdomen and back started to itch as well. Immediately I took 50 mg of Benadryl and went to sleep. Itch continued while I was trying to fall asleep. In the morning there was no rash on my body except for a small redness on my injection site. By the way, with the first shot that I had on December 19, 2020, Pfizer Lot # EH9899 in the same facility , I developed red, hot to touch, not raised rash all over my deltoid muscle of the left arm 2 days after the shot was administered and it lasted for 3 days with no change. Benadryl and Allegra did not help with shot # 1.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Vivelle dot, Norethidrone, Multivitamins,Fish oil, Probiotics, St John's Wart.",,,,"Codeine, Morphine, Maxalt","['Injection site erythema', 'Injection site warmth', 'Pruritus', 'Rash', 'Rash pruritic']",2,PFIZER\BIONTECH,IM 930680,WY,67.0,F,Patient presented to the vaccine clinic to receive her first dose of COVID vaccine. Administration and post vital signs went smoothly and vitals were stable. After patient left the facility it was discovered that the patient was given an undiluted dose of COVID vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,None,No known,No known,,No known,['Product preparation issue'],1,PFIZER\BIONTECH,IM 930681,TX,69.0,F,"redness, extensive swelling at injection site and ""fever"" at injection site. 7 days after injection intense itching started",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PHM,"flonase, singulair, valsartan, levothyroxin, pantprazole, dotti patch, simvastatin and meloxicam",not known,"hypertension, hypothyroid,allergies",,no known,"['Injection site erythema', 'Injection site swelling', 'Pruritus', 'Pyrexia']",1,MODERNA,IM 930682,TX,49.0,F,"Itching and burning raised rash on hands, wrists, injection site. Tx: Benadryl, cold compress",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,UNK,Vitamin D; Elderberry,,Juvenile rheumatoid arthritis,,None,"['Burning sensation', 'Injection site rash', 'Rash', 'Rash papular', 'Rash pruritic']",1,MODERNA,SYR 930684,WV,54.0,M,"""Moderna COVID-19 Vaccine Symptoms: chills, Fever 101, joint pain, headache, loose stools",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,SCH,Dose per day: Wellbutrin XL 450mg; Citalopram 40mg; Depakote 1000mg; Losartan 100mg; Flomax .4mg; Eliquis 10mg; ASA 80mg; Glucosamine chondroitin complex 2 tabs; Vitamin D3 5000IU; Zinc 50 mg; Vitamin E 400 IU; Prevagen Reg Strength; Suga,None,Post Covid-19 Pulmonary Emboli; High Blood Pressure; Bi-polar Disorder; obesity,,None,"['Arthralgia', 'Chills', 'Diarrhoea', 'Headache', 'Pyrexia']",1,MODERNA,IM 930685,MA,52.0,F,"Tues 1/5/21 heart flutter feeling shortly after vaccine administered (within 10 min.- went away Dizziness approx. 30 min later-went away 4pm- headache, dizziness, pain at injection site, lower back pain, scapulae pain 10pm-5am- chills, no fever Wed 1/6/21 shaking chills in/out of shower despite hot water; chattering teeth Chills and freezing all day at work- wore scarf all day and had personal heater directly on me as well as hospital heat- still freezing Felt feverish at times, though did not check temp, no sweating headache all day, severe achiness at injection site, scapulae area, lower back, hips, joints- Took Tylenol throughout day/eve Eve took 2 hr nap then bedtime around 10:30pm Shaking shills all night long/ more like rigors; husband woke me up to ask if OK as I was shaking entire bed. Freezing feeling continued No fever, did not feel hot; short time later completely soaked- nightshirt, blankets, hair as if I had been in shower Took Tylenol Thursday 1/7 Headache, achiness severe Continued feeling freezing cold ( I am NEVER cold)- could not get warm despite covered with blankets Took nap then went to bed Friday 1/8 woke with headache still- Tylenol though does not take away headache- have had continually since vaccine blisters on upper lips; blisters under both nostrils; swelling, pain of mucous membranes in nose L arm injection site red, very warm Entire upper arm hard and swollen Still with symptoms as of 8pm this eve",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,Prozac 60mg by daily Tylenol 1000mg by mouth 2 x day Multivitamin 1 by mouth daily,,"Osteoarthritis x 4 years- s/p Bilateral total knee replacements - Dec 28, 2019",,"Zantac, Reglan, Amoxacillin, Nutrasweet, Aspartame, Colophony, Rubber/adhesives","['Arthralgia', 'Back pain', 'Cardiac flutter', 'Chills', 'Dizziness', 'Feeling cold', 'Headache', 'Hyperhidrosis', 'Induration', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Peripheral swelling', 'Pyrexia', 'Tremor']",UNK,MODERNA,IM 930686,PR,50.0,F,Swollen Axillary Lymph Nodes up to the breast area.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Lisinopril 40mg,No.,"Hypertension, Anemia.",,"Tetracicline, Penincillin, Iodine",['Lymphadenopathy'],2,PFIZER\BIONTECH,IM 930687,,65.0,M,"Patient felt ""tickle/scratchiness in throat"" 10 minutes after vaccine; BP and pulse stable; no hives, itching, shortness of breath. Took 25 mg of Benadryl and monitored another 15 minutes. VSS; patient felt comfortable leaving; would be in hospital another hour or so,",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,"['Pharyngeal paraesthesia', 'Throat irritation']",1,PFIZER\BIONTECH, 930688,NM,60.0,F,"Facial flushing, different sensation to head and ears, anxiety, unable to think. Pt. evaluated by MD, Benadryl 50mg IM administered with 1 hour in clinic observation. Pt. with improved breathing and relaxation, vitals stable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"ALBUTEROL HFA 90MCG/SPRAY INHL,ORAL FLUTICASONE SOLN,NASAL SUMAtriptan TAB 25MG MULTIVITAMIN TAB FISH OIL CAP,ORAL 1000MG metFORMIN TAB,SA 500MG TIOTROPIUM INHL,ORAL 2.5MCG/ACTUAT diphenhydrAMINE CAP,ORAL 25MG PIOGLITAZONE TAB 30MG",Diabetes Mellitus GERD PTSD,Diabetes Mellitus GERD PTSD,,Acetaminophen Amoxicillin,"['Anxiety', 'Blood glucose increased', 'Flushing', 'Mental impairment', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 930689,AR,36.0,F,"Chills, fever, muscle aches, sweating spells, redness traveling down my arm under the injection site, severe arm pain, runny nose , increasing redness and swelling down anterior tricep under injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,OTH,Aczone Benzoyl peroxide gel Rizatriptan Benzoate,None,Celiac disease Raynaud?s syndrome,,Celiac; gluten,"['Chills', 'Hyperhidrosis', 'Injection site erythema', 'Injection site swelling', 'Myalgia', 'Pain in extremity', 'Pyrexia', 'Rhinorrhoea']",1,MODERNA,SYR 930690,NY,39.0,F,"I got the vaccine at 9:45am. I got a sudden sharp migraine after 3:15pm, which lasted till around 8pm. Around the same time I also experienced severe nausea, which lasted all night and I woke up with it today. I went to restroom to wash my hands and when I looked in the mirror I noticed 3 hives- 1 on my face under my left eye and 2 on my neck. My left eye was also itchy for about an hr or so.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Omeprazole (reflux disease), topiramate (migraines)",,"PCOS, IBS/ IBD, ulcerative colitis, reflux disease, migraines, chronic cough",,"Apples, chlorhexidine (when on skin)","['Condition aggravated', 'Eye pruritus', 'Migraine', 'Nausea', 'Urticaria']",1,MODERNA,IM 930691,MT,25.0,F,"body aches, nausea, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/08/2021,2.0,PVT,,,,,,"['Chills', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,IM 930692,CA,23.0,U,"sharp abdominal pain on left side, bloating. Pain subsided but bloating still present at time employee left work at 4:30pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,"['Abdominal distension', 'Abdominal pain']",1,MODERNA,IM 930693,CA,33.0,F,"4: 50 pm - 20 minutes after injection, pt reports feeling flushed, hot and itchy. pt denies breathing trouble. 5: 03 pm pt was evaluated by EMS BP 162/105, P91, O2 sat 100%, EKG done 5: 09 pm BP 136/84 P 86, O sat 100 %. Pt reports reports feeling better, declined transport to ED. Pt left AMA.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,"gabapentin, lithium, seroquel",none,none,,"latex, nuts, foods","['Feeling hot', 'Flushing', 'Pruritus']",1,PFIZER\BIONTECH,IM 930694,IN,58.0,M,Arm started getting sore then it ran through my body and I got very a hey and got a temperature. Also got chill. Went away 2 days after vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,,,,,,"['Chills', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 930695,FL,26.0,F,Flu-like body aches and shivers; increased pain with migraine; significant lethargy,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Rizatriptan; Aimovig,Migraine disease,Migraines,,Shellfish,"['Chills', 'Condition aggravated', 'Influenza like illness', 'Lethargy', 'Migraine']",1,MODERNA,SYR 930696,OR,39.0,F,"Had itchy hives on face and neck, some lip swelling, dizziness; Denied SOB or throat tightness. Pfizer vaccine was given at 11:45 AM and reaction onset at 11:55. VS at 12:10: BP 132/67; HR: 100; O2 96%; Epi given at 12:22; Was taken to ED for observation. Patient has PMHx of RA and Asthma; Meds include Methotrexate, Advair, Omeprazole, Vit D; Allergies to PCN and Percocet; Had anaphylactic reaction to sucralose for fit test.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Methotrexate, Advair, Omeprazole, Vit D",,RA and Asthma,,Allergies to PCN and Percocet; Had anaphylactic reaction to sucralose for fit test.,"['Dizziness', 'Lip swelling', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 930697,OH,24.0,F,"Aches, tiredness, joint pain, nausea, vomiting, injection site swelling and redness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,UNK,,,Chronic hives,,,"['Arthralgia', 'Fatigue', 'Injection site erythema', 'Injection site swelling', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,IM 930698,TN,34.0,F,Jaw pain in TMJ area on both sides starting approximately 36 hours after vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/08/2021,2.0,PUB,,,,,Sulfa Tetracycline,['Pain in jaw'],1,MODERNA,IM 930699,AZ,55.0,F,"Onset 1/6/21, injection site raised, red, warm to touch, swelling present, approximate size of a half dollar coin. On 1/8/21, size of welt increased to 5in x 3.5in with discomfort and soreness present, along with warm to touch. No fever present.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,Advil,,"Asthma, Reactive Airway Disease",,"Keflex, Sulfa drugs, Levaquin, Codeine","['Injection site discomfort', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Urticaria']",1,MODERNA,IM 930700,PA,53.0,F,"1/7/2020. AM- injection site size of a quarter, red, hot to touch, itchy , painful. Upper lip itchy x 3 hours . Afternoon chills, headache, joint pain, muscle aches, fatigue, nausea. 1/8/2020 3am injection site size of a 50 cent piece , red , hot to touch, itchy, painful, red bumps on upper arm and upper chest, chills, headache, joint pain , muscle aches, fatigue, nausea and diarrhea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,Levothyroxine Zoloft Protonix Pravachol Lumigan Eye Drop,11/23/2020 swabbed for Covid 19. Positive result,Thyroid Disease High Cholesterol Glaucoma Concussion,"Influenza vaccine , age late 40?s , vaccine given in fall , given at workplace.",Epinephrine Red Dye Strawberry,"['Arthralgia', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Lip pruritus', 'Myalgia', 'Nausea', 'Rash', 'Rash erythematous']",1,MODERNA,IM 930701,AK,37.0,F,Chest Heaviness/Pressure,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Chest discomfort'],UNK,PFIZER\BIONTECH, 930702,CA,49.0,F,Patient c/o generalized tingling 35 minutes after receiving vaccine. BP taken and was elevated 169/112. tachy at 101. patient brought to ED for further evaluation.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,motrin,Unknown,Unknown,,None,"['Blood pressure increased', 'Paraesthesia', 'Tachycardia']",1,PFIZER\BIONTECH,IM 930703,MD,68.0,F,"Sore throat, swollen lymph nodes, voice hoarse, no fever or cough ,started on third day after injection. Treated with Tylenol. Swollen glands improved today and throat improving but voice still hoarse.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/07/2021,3.0,WRK,"Amlodipine, Metropolol, Lisinopril, Synthroid, Famotidine",none,"Hypertension, left ventricular hypertrophy, obesity, hypothyroidism",,none,"['Dysphonia', 'Lymphadenopathy', 'Oropharyngeal pain']",1,MODERNA,IM 930704,OR,57.0,F,"At 1431, pt received the first dose of the Moderna COVID-19 vaccine. Hx of anaphylactic reactions to penicillin as a child. At 1445, pt started complaining of tongue swelling, which proceeded to increase in severity. At 1449, Epi-Pen administered (0.3 mg) in R deltoid. At 1450, 50 mg diphenhydramine IM administered in L deltoid, followed by an additional dose at 1452 in R deltoid. 911 was called between 1445 - 1450. Pt was moved to another exam room where she could lay down because she was hypotensive, lightheaded, and pale. O2 sats remained between 95-98%, BP 81/53-190/100, P 94-136, RR 16-24 throughout. Tongue swelling improved slightly after receiving Epi-Pen. EMS arrived and were able to start an IV before transporting her to the local hospital at 1502.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PUB,"Albuterol, Azithromycin, Flonase, Naproxen, Ditropan XL, Sudafed, tramadol, Flexeril, lisinopril",None,"Callus of foot, Chronic low back pain, Lumbar strain, obstructive sleep apnea, overactive bladder, essential HTN, HPV, Multiple Sclerosis, asthma, breast lump, depression",,"Penicillins, Morphine","['Dizziness', 'Hypotension', 'Pallor', 'Swollen tongue']",UNK,MODERNA,IM 930705,CA,53.0,U,Nausea but resolved soon after,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,['Nausea'],1,MODERNA,IM 930706,GA,38.0,F,"Redness, itching and swelling at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,PVT,Fluoxetine 40 mg daily Vitamin D Clonazepam 0.5 mg PRN,None,None,TB skin test,Gluten sensitivity,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 930708,MA,55.0,F,"Numbness and paresthesia around the lips and chin area. Metallic taste in mouth. Tip of Tongue feels as though I had something that was scolding hot, a mild sensation. It First happened a half hour after having the Moderna Vaccine Starting at 12:00 pm today 1/8/2021. Subsided approximately about a hour or so lat. Returning back around 6:30 pm this evening with mild numbness to my lips only and the same sensation to the tip of my tongue. No swelling and still have taste.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,none,none,"Emphysema, no medications are taken",,Erythromycin,"['Dysgeusia', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia', 'Paraesthesia oral']",UNK,MODERNA,IM 930709,LA,31.0,F,"12/17/2020 Recieved 1st Pfizer covid injection on 12/25/2020 messaged her PCP for a swollen lymph node, not painful, (stated she has noticed for two weeks) was seen in her office on 12/28/2020 Blood work, CBC, US neck recommended CT with contrast 12/30 ct was performed recommended FNA biopsy, states it could be reactive US guided biopsy is scheduled states she feels fine and no other concerns she is planning for 2nd vaccination today.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/24/2020,7.0,PVT,"Buspar, clonidine, adderal, YAZ, aldactone",,,,None known,"['Chest X-ray normal', 'Computerised tomogram thorax', 'Electrocardiogram T wave inversion', 'Electrocardiogram normal', 'Lymphadenopathy']",1,PFIZER\BIONTECH,SYR 930711,,38.0,F,First day: Warm Next day: Soreness on left arm at injection site Body Aches,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Injection site pain', 'Pain', 'Skin warm']",1,MODERNA,SYR 930712,AL,50.0,F,"Headache, chills , achy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,No,None,No,,None,"['Chills', 'Headache', 'Pain']",UNK,MODERNA,IM 930713,,39.0,F,"Tickle in throat / throat itching, Can't get a full swallow, anxious, jittery",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,Unknown- no access to snapshot in EMR,Unknown- no access to snapshot on EMR,Unknown- no access to snapshot on EMR,,"Latex, Codeine, Walnuts","['Anxiety', 'Dysphagia', 'Feeling jittery', 'Pharyngeal paraesthesia', 'Throat irritation']",1,PFIZER\BIONTECH,IM 930714,OR,43.0,F,"Dry throat progressed to cough that continued to severe cough, difficulty breathing, while driving. Pulled over and contacted paramedics. Outcome unknown at time of report",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,"levothyroxine, escitalopram, metropolol, losartan, spironolactone",,,,vancomyacin,"['Cough', 'Dry throat', 'Dyspnoea']",1,MODERNA,IM 930715,VA,27.0,F,"swollen left eye, hives on arms and legs, stuffy/runny nose",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,none,none,eczema,,penicillin and metals on skin,"['Eye swelling', 'Nasal congestion', 'Rhinorrhoea', 'Urticaria']",1,PFIZER\BIONTECH,IM 930716,,34.0,F,Redness and heat surrounding injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/08/2021,8.0,UNK,,,,,,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,UN 930717,UT,35.0,F,"Client c/o of SOB 15 min after vaccine was given, EMS was called 10 min later, EMS instructed to use epi pen. Epi was given per EMS. Client felt better. EMS transported client to medical facility.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PUB,albuterol,unknown,asthma,,"flu shot, latex, eggs, nuts, fruit",['Dyspnoea'],1,MODERNA,IM 930718,IN,38.0,F,"Within 3 minutes of receiving vaccine, associate became flushed, tachycardic, tingling to chest and abdomen, and weakness of legs. She was observed for 35 minutes by Drs. during this time period. Symptoms resolved in entirety during this time. Associate was later contacted by Dr. via phone follow-up 1 hour after leaving vaccine clinic and associate reports symptoms continue to be resolved and did not reoccur.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,None,,,,NKDA,"['Flushing', 'Muscular weakness', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 930719,PA,24.0,F,"Redness, swelling,itching, pain at injection site? about 2 inches in diameter",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Sertraline 50mg,,,,"Keflex, seafood","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 930720,CA,37.0,M,"4:15 pm- 10 minutes after injection pt reports feeling dizzy, cold, and throat dryness. Pt denies short of breath, chest pain or swallowing difficulties. 4:20 pm Pt evaluated by EMS. BP 140/108, P 95, O2 sat 100% 4:25 pm BP 142/99, P 94, O2 sat 100 %. pt reports feeling better and declined transport to ED",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PUB,"vitamin D, unsure name of anxiety medication",,anxiety,,,"['Dizziness', 'Dry throat', 'Nasopharyngitis']",1,PFIZER\BIONTECH,IM 930721,IN,50.0,F,"Extreme headache, very painful joints",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"Adderall, Ambien, Lexapro, Valium, Zanaflex, D3, Biotin, Evening Primerose",None,"Stroke (due to surgical error), BMI over 40",,Hydrocodone,"['Arthralgia', 'Headache']",1,MODERNA,SYR 930722,NM,57.0,F,Pt. started feeling tingling in lips and facial flushing within 2 minutes after administration. Dr. in clinic for pt. assessment. Pt. uneasy/anxious with increased facial flushing to face and some mild swelling to lips. Pt. with tingling sensation to right side of body. Benadryl 100mg IM administered immediatly per Dr.'s order. Epi-Pen also available if needed. Pt. with improved redness to face and lips after administration.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Percocet 5-325mg, albuterol HFA inhaler, albuterol SO4 nebulizer solution, apsirin 81mg, calcium 500mg/vitamin D 200 units, cyclobenzaprine 10 mg, cyclosporine ophthalmic emulsion, famotidine 20mg, folic acid 1mg, hydroychloroquine 200 mg,",,"hypertension, GERD, hypothyroidism, lupus, rheumatoid arthritis, asthma",,"leflunomide (dyspnea, rash, pruritis, nausea), methotrexate (anaphylaxis)","['Anxiety', 'Erythema', 'Flushing', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 930723,FL,32.0,F,"Fever, joint pain, back pain, headache Took 800 mg of ibuprofen twice with some symptom relief",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Advair, ventolin, singular, Zyrtec, super B complex, one-a-day women?s multivitamin, complete omega, joint complex, turmeric, jolessa",None,Asthma,,"Dust, pollen, mold, grass","['Arthralgia', 'Back pain', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930724,VA,36.0,F,Low grade generalized itching without rash beginning approximately 5 hours after injection; injection site soreness within an hour of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,none,none,none,,none,"['Injection site pain', 'Pruritus']",1,MODERNA,IM 930725,MO,53.0,F,"Entered post-monitoring area at 1750, notified RN of prior itching and hives post first dose COVID-19 vaccination. Reported that she had taken Benadryl 50mg PO after first vaccination. Pt reported today 1/7/20, she took medication prior to COVID-19 vaccination: Pepcid 40mg PO at 1626. Benadryl 25mg PO at 1626. 1810: pt c/o scalp itching, visible redness to itchy area on scalp. BP 158/84 (101), HR 82, regular rhythm, SpO2 97%, RR 18, Temp=97.5F 1812: 25mg Diphenhydramine HCL oral solution given PO for itching to scalp. 1818: BP 159/93 (108), HR 78, regular rhythm, SpO2 98%, RR 17, Temp =98 F 1822: Splotchy redness noted to pt's L lower arm, no itching. Redness noted to L upper chest with pt c/o itching to L upper chest area, R neck, nose and R toes itching. Pt denies difficulty breathing, swallowing. SpO2=98% 1830: BP 172/84 (105), HR 82, regular rhythm, SpO2 100%, RR 16, Temp=97.5 F Pt denies any new areas of itching, scalp, R toes, R neck and R chest area still itchy. No c/o difficulty swallowing or breathing. No throat clearing. 1837: pt notes improvement in scalp and nose itching. Redness to L arm and chest improved. 1845: BP 165/80 (102), HR 85, regular rhythm, RR 16, SpO2=99%, Temp =98.2 F Pt c/o itching again to R side of scalp with redness noted to scalp. 1850: 25mg Diphenhydramine HCL oral solution given PO for itching and redness to scalp. 1900: BP 153/87 (104), HR 85, regular rhythm, RR 12, SpO2=98%, Temp=97.6 F Pt reports mild scalp itching with some improvement since second dose of diphenhydramine. No other itching or redness noted. 1915: BP 171/86 (107), HR=80, regular rhythm, RR 12, SpO2=99%, Temp=97.4 F pt reports mild itching to L scalp and L chest, no significant redness noted. 1930: Pt denies worsening symptoms, no additional itching or redness. Gave pt discharge instructions to not exceed 100mg of Diphenhydramine in a 4 hour period. Recorded times and amounts of diphenhydramine given during post vaccine monitoring period. Pt denies feeling drowsy and is comfortable driving home. Directed patient to call emergency services from home with any worsening of rash or trouble breathing, feeling faint, or any other concerning symptoms. Pt's husband will be at home with pt, aware of additional monitoring needed post vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,asthma,itching and redness,"codeine, augmentin, oxycodone, nickel, penicillin, corn, watermelon, cantalope","['Dysphagia', 'Dyspnoea', 'Erythema', 'Pruritus', 'Rash macular', 'Urticaria']",2,PFIZER\BIONTECH,IM 930726,NC,44.0,F,"Fever to 101.4, rigors/ chills. Nausea and vomiting. Swollen axillary lymph nodes, body aches and headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Headache', 'Lymphadenopathy', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 930727,OR,36.0,F,"Instant bleeding at site, with arm swelling and pain--held firm pressure; followed by scratchy throat requiring 50 mg benadryl. Monitored x 30 minutes. Benadryl helped with scratchy throat, but arm was still very painful and swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,possibly asthma,,"milk, soy, almonds, eggs","['Immediate post-injection reaction', 'Injection site haemorrhage', 'Pain in extremity', 'Peripheral swelling', 'Throat irritation']",1,MODERNA,IM 930728,IN,56.0,F,Sore arm at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,UNK,Vit D Estrogen/Progesterone,,,,Sulfa,['Injection site pain'],UNK,PFIZER\BIONTECH, 930729,KY,48.0,F,"3 days of extreme pain and swelling and inflammation at injection area as well as headache, nausea and dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,"Cymbalta, Buspirone, Albuteral inhaler",None,"Anxiety, Depression",,None known,"['Dizziness', 'Headache', 'Injection site inflammation', 'Injection site pain', 'Injection site swelling', 'Nausea']",1,MODERNA,IM 930730,CA,31.0,F,"2:45 pm - 10 minutes after receiving vaccine pt reports throat tightness and sensation of lump in throat, and rash to face and chest 2:50 Pm pt evaluated by EMS and transported to Hospital pt reports is 10 weeks pregnant",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PUB,,,,,"corn, gluten, other foods","['Exposure during pregnancy', 'Rash', 'Sensation of foreign body', 'Throat tightness']",1,PFIZER\BIONTECH,IM 930731,NH,37.0,F,"Redness, pain swelling at the area for 2-3 days, then almost completely went away. Day 7, redness, swelling, hot area developed with off and on again low grade fever. Area spread downwards for 2 days, then stopped spreading, swelling gone, redness faded somewhat but red area is still present and low grade fever still off and on.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2000,01/05/2021,7312.0,OTH,Nuvaring,None,None,,None,"['Erythema', 'Feeling hot', 'Pain', 'Pyrexia', 'Swelling']",UNK,MODERNA,SYR 930732,TX,52.0,F,"Had minimal pain at injection site on night of vaccine 12/30/20 and the next day 12/31/20 with no redness or swelling at the site. On 1/1/21 the pain had gone and still had no redness or swelling at the site. Then on 1/7/21 around 1400 I noticed it was itching at the injection site and there was a 1cm area of redness and induration. By 2100 on 1/7/21 the redness and induration had grown to 5-6cm and area was warm. On 1/8/21 by 1500 the redness and induration had grown to 8cm and redness starting to go down the arm. At 1900 the area is still about 8cm and now left axillary lymphadenopathy has developed. I am a NP and am watching it, I will seek treatment tomorrow if no improvement or if it worsens.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,PHM,"Levothyroxine 125mcg, Estradiol 2mg",None,Hashimotos Thyroiditis,,"Penicillin, Bactrim","['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Lymphadenopathy']",1,MODERNA,IM 930733,IN,27.0,F,"Nausea. Vomiting. Migraine. Hot, but had constant cold chills Body aches, head to toe. Extremely tired. Super sore on injection site and about 4 inches surrounding.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Birth control patch,No,No,,No,"['Chills', 'Fatigue', 'Feeling cold', 'Injection site pain', 'Migraine', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,SYR 930734,TX,63.0,F,headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,unk,unk,"HTN, chronic smoker",,unk,['Headache'],2,PFIZER\BIONTECH,IM 930735,FL,42.0,F,"Moderna COVID-19 Vaccine My injection site started to get red, fevered to the touch, hard and itch and tingle. 7 days after my 1st dose of the vaccine (01/07/2021 . The red site is about the size of a ?playing card.? I have felt fine other than the place on my arm, NO trouble breathing, no rapid heart rate, no rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/31/2020,01/07/2021,342.0,PVT,Duloxitine 30 mg QD Losartan 50mg QAM HCTZ 12.5 mg QAM Celebrex 200mg QD Metformin 500 mg 1BID,,,,NKA,"['Injection site erythema', 'Injection site induration', 'Injection site paraesthesia', 'Injection site pruritus', 'Injection site warmth']",UNK,MODERNA,SYR 930736,IN,42.0,F,"Dizzy, lightheaded, left arm numb. O2 saturation 98%. HR 68 and strong. No SOB. Color pink. BP WNL. Laying down, drinking juice. After lying flat and drinking juice pt. began to feel better. Symptoms resolved and felt ok to leave. Encouraged to go to ED if symptoms worsen.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,WRK,Claritin,None,Exercise induced asthma,,"PCN, Sulfa","['Dizziness', 'Hypoaesthesia']",1,MODERNA,IM 930737,TX,61.0,M,"Approximately 18 hrs after vaccination, pt woke up with injection site soreness, Tmax 104, dizziness, myalgias, athralgias.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,Metformin Glipizide Lisinopril Dulaglutide,None,"BPH, HTN, HLD, DM",,NKDA,"['Arthralgia', 'Body temperature increased', 'Dizziness', 'Injection site pain', 'Myalgia']",1,MODERNA,IM 930738,TX,52.0,F,"Immediately after receiving vaccine patient reports numbness at the right arm, just below the elbow. Patient cleared by EMS, patient Patient advised to call 911 or go to the nearest emergency room for any additional issues as needed. Also advised to sign up for v-safe.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PUB,,,,,,"['Hypoaesthesia', 'Immediate post-injection reaction']",1,MODERNA,IM 930739,TX,35.0,F,"Large spot of irritated skin at injection site that has grown over a period of 5 days; took Benadryl capsules by mouth and applied Benadryl ointment, cold compress to the site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PVT,"Advair (115/21), Fluoxetine (20mg), Zyrtec (10mg)",Sinus infection,Asthma,,"Crustaceans (shrimp, crab, etc.)",['Injection site irritation'],1,MODERNA,SYR 930740,OR,61.0,F,"Blurry vision, hard time focusing, ""even with my glasses.""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,"RA, celiac, history of breast cancer requiring lumpectomy, radiation, chemo. Fibromyalgia.",,"nitroglycerin drug intolerance, reported as ""low BP""",['Vision blurred'],1,MODERNA,IM 930741,WA,32.0,F,cellulitis / skin reaction developing 4 days later Started cefadroxil for cellulitis and resolved completely after 2 days. Back to normal,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,PVT,"acyclovir, fluoxetine",one,"obesity, anxiety",,"adhesives, pcn","['Cellulitis', 'Differential white blood cell count normal', 'Full blood count normal', 'Skin reaction']",1,MODERNA,IM 930743,TX,50.0,F,"Right arm swelling, redness onset 9days after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,PHM,"Fluoxetine, levothyroxine, vit d3, multivitamin",None,"PMS, hypothyroidism",,None,"['Erythema', 'Peripheral swelling']",1,MODERNA,IM 930744,CA,33.0,F,"Large, swollen, indurated, erythematous wheel noticed at 7AM on 1/7/2021 Temperature was 99.9 at 11:07AM, 100.4 at 12:38PM, 101.6 at 2:08 PM, 102.3 at 5:30pm on 1/7/2021 During the day, significant muscular pain in the low back and throughout Took Tylenol for first time at 5:45pm with resolution of the fever causing significant sweating. Abdominal discomfort beginning 1/7/2021 with loose stool 1/8/2021 Fatigue all day 1/7/2020",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"bupropion XL 300mg daily, spironolactone 100mg BID, advair 250 BID, sprintec, melatonin 10mg QHS",,PCOS Covid-induced Asthma (Covid symptoms since 3/11/2020. Diagnosed 3/14/2020),Hepatitis B Vaccine <10 years old. Had a high fever.,,"['Abdominal discomfort', 'Back pain', 'Body temperature increased', 'Diarrhoea', 'Fatigue', 'Hyperhidrosis', 'Induration', 'Myalgia', 'Rash erythematous', 'Swelling', 'Urticaria']",1,MODERNA,IM 930745,CA,72.0,F,"Day of injection - sore injection site Day 1 post injection - headache, nausea Day 2 post injection - nausea Day 3 post injection - increasing nausea, gas Day 4 post injection - Loose stool x 7, gas, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,AM Meds: PRN: Fexofenadine 60mg Combivent Respiramat 20mcg/100mcg Spironolactone 25 mg Fiorinal w/codeine 3,,"Asthma, Left Bundle Branch Block, hypertension, diastolic dysfunction, hypothyroid, Migraines, dysplastic nevi, basal cell carcinoma nose (2007), basal cell carcinoma L thigh 2008, squamous cell CA R cheek (2013), Basal cell CA L eye inner canthus x 2 (last 2/2019), concussion (2002), G2 P2 pneumonia (2/2009), osteopenia (2018), diverticulitis (12/2019)",,"Allergies: Azithromycin (anaphylaxis) PCN (rash, hives after taking Augmentin) Percodan (side effect - itching)","['Diarrhoea', 'Flatulence', 'Headache', 'Injection site pain', 'Nausea']",1,PFIZER\BIONTECH,IM 930746,TX,61.0,F,Patient complained of being dizzy and having anxiety after immunization. Patient cleared by EMS. Patient advised to call 911 or go to the nearest emergency room for any additional issues as needed. Also advised to sign up for v-safe.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PUB,,,,,,"['Anxiety', 'Dizziness']",1,MODERNA,IM 930747,CA,53.0,U,Nausea but resolved soon after,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,['Nausea'],1,MODERNA,IM 930748,NM,51.0,F,Severe heartburn with gastric reflux. MD notified antacid prescribed. Pt. provided 15ml of ALOH/MGOH/SIMETHICONE 400/400/40MG/10ML. No SOB or chest pain noted. Heartburn pain decreased from 5/10 to 1/10 15minutes after medication administration.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"IBUPROFEN TAB CALCIUM 500MG/VIT D 200 UNIT TAB GABAPENTIN TAB 600MG LOSARTAN TAB 100MG ALBUTEROL/IPRATROPIUM 3MG/0.5MG/3ML NEB ALOH/MGOH/SIMETHICONE 400/400/40MG/10ML FUROSEMIDE TAB 20MG METFORMIN 1000MG TAB,ORAL 1000MG CARBAMAZEPINE",,Diabetes Mellitus Hypertension Osteoarthritis,,Codeine Topamax,"['Dyspepsia', 'Gastrooesophageal reflux disease']",1,MODERNA,IM 930749,CA,60.0,F,"L shoulder tightness and throbbing, light headedness, tightness in hand / jaw / shoulder",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,aspirin 81 mg,,"MI 2014, hypertension, anxiety, panic attacks",,,"['Dizziness', 'Limb discomfort', 'Muscle tightness', 'Musculoskeletal stiffness', 'Pain']",1,MODERNA,IM 930750,NJ,26.0,F,1) 100.4F body temperature. Body aches and fatigue. Lasted ~12 hours. 2) Injection site soreness. Lasted ~12 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,Escitalopram 10mg/day Vitamin D3 2000IU/day Vitamin C 1000mg/day Spirulina 3g/day Fish Oil 1g/day Magnesium 300mg/day,Anxiety,Eczema,"Injection site soreness (~12 hours long), 26 years old, Sept 2020, flu shot, N/A","Penicillin, peanuts","['Body temperature increased', 'Fatigue', 'Injection site pain', 'Pain']",1,MODERNA,IM 930751,IL,45.0,F,"Fever 102.5 x 24 hours at this time. Chills, body aches, headache and fatigue. Some chest discomfort",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Buspar Prozac prevacid,Covid 12/8/20,Asthma,,No,"['Chest discomfort', 'Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930752,OR,66.0,M,"Pt received 1st dose of Moderna COVID-19 vaccine on 01/04/2021 in L deltoid. Came back to clinic at 0800 on 01/06/2021 c/o excruciating pain in entire L arm radiating to neck, chest, and around his upper and lower back. States it started the evening of 01/04/2021 and progressively has gotten worse. States it woke him up at 0130 on 01/06/2021 and that he hadn't been able to get back to sleep because of the pain. Rated pain 9.5/10. No redness or s/s of infection at injection site. Some swelling present at the site. L forearm and hand were slightly erythematous, and he was unable to move arm or fingers much. RN had to assist with putting his jacket back on. States has tried ice packs, tylenol, ibuprofen, tramadol, gabapentin, and oxycodone with no relief. BP 143/93, P 77, RR 22, O2 sat 96%. Advised to call PCP and either wait until urgent care in town opens at 1100, or if he can safely drive to another city, go to urgent care there because they open at 0800. Advised if unable to drive to other city and can't wait until 1100, to go to the ER. On 01/07/2021, called pt in the evening to follow up. Pt stated he did go to the ER in town right after coming to the clinic, where they performed an ultrasound of his arm to check for retained fluid, but his results were normal. Pt states ER advised him to try hot packs on his arm and to return if he still found no relief. Pt states the hot packs did help some, but was still experiencing pain 6/10, but that the intensity of it had worn off a little and that it was becoming more manageable",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PUB,"tramadol, gabapentin, oxycodone",,Rheumatoid Arthritis,,Unknown,"['Back pain', 'Chest pain', 'Condition aggravated', 'Erythema', 'Injection site swelling', 'Musculoskeletal stiffness', 'Neck pain', 'Pain', 'Pain in extremity', 'Sleep disorder', 'Ultrasound joint']",UNK,MODERNA,IM 930753,MA,60.0,M,"I woke up at approximately 4:00 am with an extremely dry mouth. I went into the bathroom and took a drink of water. I returned to bed. I noticed that my breathing was becoming more rapid. I had trouble catching my breath. I sat up on the side of the bed. My heart was pounding and quick. My breathing was difficult. I woke up my wife. After about 5 minutes my symptoms improved. She took my pulse which was now at 62ppm. I laid back down in a reclined position. My symptoms of difficulty breathing and elevated heart rate quickly returned. My pulse was now up to 98 ppm. I sat up again. My symptoms gradually improved. Being unsure of what was going on my wife called 911. The ambulance arrived in about 8 minutes. I was about 60% better. Vitals were improving other than my blood pressure which was 180/100 Being unsure of what was happening, I was transported to Hospital. I had a chest x-ray, a chest CT scan with contrast to rule out a blood clot, blood work including tests to rule out MI x2. All test were negative. By about 6:30 am I was feeling at least 80% better. My breathing I felt had returned to normal. My pulse was down into the 50""s which is my normal range.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PUB,"lisinopril 10mg, rosuvastatin 10mg, baby aspirin, multi vitami Co-Q10 400mg",none,neutropenia,,none,"['Blood pressure abnormal', 'Chest X-ray normal', 'Computerised tomogram thorax', 'Dry mouth', 'Dyspnoea', 'Heart rate increased', 'Laboratory test normal', 'Palpitations', 'Respiratory rate increased', 'Scan with contrast normal']",UNK,MODERNA,IM 930754,AR,34.0,M,Onset of dizziness within moments of receiving the vaccine which has persisted for hours and has not let up but is mostly mild. Mild nausea at the moment.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,,,,,"Penicillin, Keflex","['Dizziness', 'Nausea']",1,PFIZER\BIONTECH,IM 930755,MN,40.0,F,"Increase in blood pressure, feeling of ""ice sensation down vaccination arm (Left), was ok during the 15 minute observation period then returned and requested EpiPen, felt swelling may be starting, 1 Epi pen administered and 911 called, EMS took patient to local hospital for additional observation and treatment if needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,SEN,unknown,none,none known,,"penicillin, biacin, erythromycin, morphine, ambien","['Blood pressure increased', 'Feeling cold', 'Swelling']",UNK,MODERNA,IM 930756,NH,36.0,M,"Fever, aches and arm pain. Did seem to resolve with Tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,,COVID-19 positive approximately one month ago,,,,"['Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 930757,TX,39.0,F,She has shortness of breath the next day,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/04/2021,1.0,WRK,,None,History of ashma,,None,['Dyspnoea'],1,PFIZER\BIONTECH,IM 930758,TX,36.0,F,Raynauds developed in third digit of the right hand. Tip was completely numb and white. Resolved after 20 minutes in hot water. No history of raynauds. Also headache and nausea and body aches.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Trintellix, restoril, vitamin d, women?s one a day, crazybulk supplements",None,None,,None,"['Headache', 'Hypoaesthesia', 'Nausea', 'Pain', ""Raynaud's phenomenon"", 'Skin discolouration']",1,MODERNA,IM 930759,WI,53.0,F,"11:40AM PATIENT STARTED FEELING RED/ITCHY/WARM 11:45AM 50MG DIPHENHYDRAMINE ORAL GIVEN 11:58AM BLOOD SUGAR 123. PULSE 72. PATIENT DRANK COCA COLA 12:21PM BREATHING HEAVY, THROAT FEELING OKAY/NOT SWOLLEN 12:30PM WOBBLY LEGS 1:20PM PATIENT CALLED PCP, SUGGESTED PATIENT GO TO ER DUE TO BLOOD SUGAR DOWN TO 55 WHILE EATING SANDWHICH AND AFTER HAVING SODA. 2:10PM PATIENT FEELING BETTER, BP DOWN, OK TO WALK 3:30PM WENT TO ER, 5PM DISCHARGED ON PREDNISONE FOR REACTION",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,"TYPE 1 DM, ASTHMA, TACHYCARDIA",,"GENTAMICIN, PHENOL","['Blood glucose decreased', 'Blood glucose increased', 'Blood pressure increased', 'Dyspnoea', 'Erythema', 'Muscular weakness', 'Pruritus', 'Skin warm']",1,MODERNA,IM 930760,GA,51.0,F,Severe headache intractable to NSAIDs and acetaminophen. Pain and swelling at injection site. Body aches and temp to 101.1,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,WRK,"Synthroid 88mcg, Vit D, ambien 10mg, melatonin, estrogen 1mg, MVI, fiorcet prn",None,"Hypothyroid, migraine, vit d deficiency",,"NKDA, NKFA","['Body temperature increased', 'Headache', 'Injection site pain', 'Injection site swelling', 'Pain']",1,MODERNA,IM 930761,NY,33.0,F,"Swollen, red rash on both legs that is itchy. Started a few hours after the vaccine and continued to get worse and more swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Lyrica Vyvanse Baclofen Trazodone Vraylar Ambien Valium Plaquenil Colchicine,Lupus Familial Mediterranean Fever Bipolar disorder ADHD,Lupus Familial Mediterranean Fever,,Erythromycin Augmentin,"['Peripheral swelling', 'Rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 930762,NJ,45.0,F,"Fever, chills, muscle and joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Birth control, Claritin, Prilosec, Vitamin C, Vitamin B12, 5-HTP",N/a,N/a,"Covid Pfizer, 45, 12/17/20, hives about 4 days later",Penicillin,"['Arthralgia', 'Chills', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 930763,TX,27.0,F,"On Wednesday January 6th, I started to have itching, swelling, and redness at the injection site. The injection site continued to swell and was warm/hard to the touch, with mild pain. I took Benadryl that night (Jan 6th). On the morning of January 7th, the swelling had gone down but redness and warmth at injection site was still present. I took Benadryl that night (Jan 7th) as well. Today, January 8th, the redness and warmth is still present.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"Wellbutrin XL, Adderall, Tylenol extra strength",None,"Anxiety, depression, adult ADHD",,"Sulfa drugs, Phenergan","['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 930764,DE,60.0,F,"Excruciating pain in left hip, lower back, and middle of back for the past two weeks. Coughing, tiredness, and headaches for the past two weeks.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,WRK,Venlafaxine HCl ER 150mg cap BusPIRone HCl 15 mg tab BuPROPion HCl XL 300mg tab Losartan Potassium 25mg tab Carvedilol 6.25 mg tab Atorvastatin mg tab Aspirin 81mg Symbicort 160-4.5 mcg inhaler PRN Albuterol hfa90 mcg inhaler PRN,None,Heart disease COPD,,Codeine,"['Arthralgia', 'Back pain', 'Cough', 'Fatigue', 'Headache', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 930766,CA,52.0,F,"Mid back pain, Right hip numbness, macular rash on administered arm",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,"multi-vitamin, acetaminophen",,controlled DM,,"keflex, latex","['Back pain', 'Hypoaesthesia', 'Rash', 'Rash macular']",UNK,PFIZER\BIONTECH, 930768,RI,42.0,F,Headache within 45 min of injection. Nausea and Headache after 24 hours. Currently almost 36 hours later I am still nauseous. I took Zofran. And extra strength tylenol. My blood sugars are running a little high despite insulin pump and frequent monitoring. No ketones. Temp is 100.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,SEN,Insulin Humalog via insulin pump 81 mg aspirin daily 25mg metoprolol succinate daily 50 mg. Losartan daily 10 mg lipitor daily 3mg trulance daily Vit d 2000u daily,N/a,Type 1 diabetes 1993 Nstemi 2018 Seasonal allergies,,Pcn,"['Blood glucose increased', 'Body temperature increased', 'Headache', 'Nausea']",1,PFIZER\BIONTECH,IM 930769,OH,56.0,F,"Fever 100.7, severe joint pain, chills, headache, stiffness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,Ability. Coumadin Lexapro d3 Vesicare. Prenatal Trintellix Lamictal Lythironine,No,Blood clotting disorder Depression,,No,"['Arthralgia', 'Chills', 'Headache', 'Musculoskeletal stiffness', 'Pyrexia']",1,MODERNA,IM 930770,NJ,48.0,F,"Extremely itchy all over. Redness on neck, chest, arms and trunk. Raised red areas over same",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/08/2021,2.0,PVT,Advil,Sinus Infection,None,,Percocet,"['Erythema', 'Pruritus', 'Rash', 'Rash papular']",UNK,MODERNA,IM 930771,CA,49.0,F,"developed flushed sensation, tingling all over, lightheadedness right after receiving Pfizer COVID-19 vaccine. By the time of assessment in ED, sxs have resolved other than residual numbness of lips.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,none,"['Dizziness', 'Flushing', 'Hypoaesthesia oral', 'Immediate post-injection reaction', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 930772,CA,58.0,F,"itchy throat, HR 108, BP 161/107 > 149/87",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,amlodipine,,hypertension,,"shellfish, seasonal allergies",['Throat irritation'],1,MODERNA,IM 930773,CA,89.0,F,Patient reported having light headedness and then developed chest heaviness. 911 was activated to respond to the facility.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,SEN,Not reported,None reported,"A-fib, CHF, Asthma",,"Sulfamethoxazole, Tramadol, NSAIDs, Latex, Vicodin","['Chest discomfort', 'Dizziness']",1,MODERNA,IM 930774,OR,28.0,F,"Pt developed firm, tender, indurated area at injection site 2cm after initial soreness wore off about 2-3 days ago. Also having some night sweats and mild sweating during the day. Temp of 99.3.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/07/2021,7.0,PVT,Sertraline,None,None,,NKDA,"['Body temperature increased', 'Hyperhidrosis', 'Injection site induration', 'Injection site pain', 'Night sweats', 'SARS-CoV-2 test negative']",1,MODERNA,IM 930775,IN,64.0,M,"Severe musculoskeletal pain, severe fatigue, poor memory, poor cognitive function, weight loss, loss of appetite, injection site pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,WRK,"Altace, ads, metro pro lol, maxzide",None,"CRF, CAD, HTN, Factor V Leiden",,None,"['Cognitive disorder', 'Decreased appetite', 'Fatigue', 'Injection site pain', 'Memory impairment', 'Musculoskeletal pain', 'Weight decreased']",1,MODERNA,IM 930776,SC,51.0,F,"Facial swelling, shortness of breath, nasal stuffiness, tachycardia >150, IV solumedrol, Benadryl and Pepcid Relief in symptoms upon discharge at 2330",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,"Levothyroxine, duloxetine, symbicort, albuterol, Flonase, lorazepam","Allergy symptoms due to running heat at home, dust",Mild asthma Allergies Hypothyroidism PTSD/depression,"Age:21, mild reaction to multiple vaccinations for work. Unknown which caused adverse reaction","Environmental, dust, bees, wasps, latex, penicillin, morphine","['Chest X-ray', 'Dyspnoea', 'Electrocardiogram', 'Laboratory test', 'Nasal congestion', 'Swelling face', 'Tachycardia']",2,PFIZER\BIONTECH,IM 930777,NY,36.0,F,"Patient presented to the emergency department with sensory loss and loss of reflexes, evaluated by neurology and diagnosed with Guillain- Barre Syndrome thought to be secondary to the Pfizer Covid Vaccine",Not Reported,,Yes,Not Reported,,Yes,N,12/23/2020,12/31/2020,8.0,PVT,,,,,,"['Areflexia', 'Guillain-Barre syndrome', 'Laboratory test', 'Magnetic resonance imaging', 'Sensory loss']",1,PFIZER\BIONTECH,IM 930778,TX,37.0,M,7cm diameter area of redness and induration. Mild local soreness and warmth.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,PVT,none,none,none,,none,"['Erythema', 'Feeling hot', 'Induration', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 930779,CA,62.0,F,"10:23pm felt a slight headache and nausea. Left work at 10:43pm since didn't feel good. While on road, my tongue started to tingle and then my lips started to tingle and both sides of face felt numb. This started around 10:50pm? Went to bed and woke up Sat with same tongue, lip tingleling and face numbness. Lips felt very swollen. Felt that way throughout the weekend. On Monday, went back to work place injection area and requested someone talk to me. Nurse practioner came out and spoke to me, asked about balance of facial features, no problem breathing or swallowing and gave me 25mg benadryl to take 3 times a day. Did nothing but make me sleepy. She calls me Tue am and told me to make an appt with PCP. Made phone appt for Wed. Dr calls me Wed am and gives me presciption for 60mg Prednisone to take for a week (at this time symptoms are the same). the first 3 days taking Prednisone the intensity of tingleling seems to lessen day by day. But on 4th day, the symptoms stopped lessening. Finished the meds anyway. Last 3 days, i've also had that mild headache back in addition to the numbness from face traveling up to my ears. Past few days the tingling in tongue isn't confined to just the edges of the tongue. It started with the first 1/4 of whole tongue and is today tingleling in the front half of whole tongue. One good thing so far is the past few days, my lips feel way less swollen and tingleling is lessening. So, riding this out, hoping it will end sometime this year. Will not be getting the second shot. Just so you know.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,"vitamin C, hair, skin nails capsule, vitamin D",none,pre diabetic,,"NSAIDS, Pravastatin, msg and tape adhesive","['Headache', 'Hypoaesthesia', 'Lip swelling', 'Malaise', 'Nausea', 'Paraesthesia oral', 'Somnolence']",1,PFIZER\BIONTECH,IM 930780,CA,26.0,F,"At 1545 patient c/o tingling lips. At 1600 patient c/o trouble swallowing and Epi 0.3mg administered at 1605 in R thigh. At 1613 patient reported trouble swallowing wasn't improving, 25mg po Benadryl given without difficulty and 911 called.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,SEN,Unknown,None,None,,NKDA,"['Dysphagia', 'Paraesthesia oral']",1,MODERNA,IM 930781,CA,24.0,F,"I woke up at 2am with a fever of 102.3, body aches, chills and headache. The fever lasted for 24 hours and the headache lasted 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,None,None,Asthma,,None,"['Chills', 'Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 930782,FL,31.0,M,"After receiving the injection, patient become disoriented. After waiting in the parking lot for 15 minutes, patient developed a few hives, was dizzy, chest was tight, and patient had overall discomfort. Patient went back into the facility and reported to staff and was given Benadryl, which slowly started to help. Patient eventually was able to leave, but symptoms, although got better with the benadryl, was uncomfortable for a while, and chest was tight, with dizziness. Hives went away after ingesting medication.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Lexapro, Prilosec, Propanolol",None,None,,"Sulfa Medications, Bananas, cats, Avacado","['Chest discomfort', 'Discomfort', 'Disorientation', 'Dizziness', 'Urticaria']",1,MODERNA,SYR 930783,TX,68.0,F,"fever, chills, bad stomach slow fever which increased",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PUB,"Levothoroxine, Vit D3, Probiotic, zinc, Wellbutrin,Hydrocholithide, Blood Pressure med,",,"vulnerable respiratory system. Have had Viral Pneumonia twice and in 2017 hospitalized with Bacterial Pneumonia , and Viral Pneumonia for eight days at hospital chronic cough",,Sulfa Drugs,"['Abdominal discomfort', 'Chills', 'Pyrexia']",UNK,MODERNA, 930784,CA,36.0,F,"Tingling lips for short duration, resolved without aid. No desire to be evaluated.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,SEN,,,,,,['Paraesthesia oral'],1,MODERNA,IM 930785,LA,41.0,M,"Really painful dead-arm, body got chills then switched to getting hot after a few hours, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,WRK,Levothyroxine,,,,,"['Chills', 'Fatigue', 'Hypoaesthesia', 'Pain in extremity']",1,MODERNA,SYR 930786,CA,61.0,F,"Tachycardic, HR to 108, BP 152/72, improved over 5 minutes sitting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,amlodipine,,hypertension,,penicillin,['Tachycardia'],1,MODERNA,IM 930787,NH,27.0,F,Approximately a 1 inch large lump in my left armpit. Painful. Have never had anything like this before,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/08/2021,6.0,PVT,Tri-sprintec (birth control) Biotin Femdophilus,None,None,,None,"['Axillary mass', 'Axillary pain']",1,MODERNA, 930788,NJ,49.0,F,"Patient reported dizziness after injection. Given gatorade and pretzel. Still reporting head fogginess and dizziness with clammy hands. 12:33 pm head fogginess was better, no further clamminess in hands. Stood up and reporting feeling better. Increased observation time to 30 minutes. At 45 minutes patient feeling better. Care provided by RN on staff .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,,,,,,"['Cold sweat', 'Dizziness', 'Feeling abnormal']",1,MODERNA,IM 930789,AZ,58.0,F,"Difficulty breathing; chest pain, headache. vital signs at 1148: BP 188/97; pulse 107. Vital signs at 1153: BP 162/99, pulse 99; respiration 22; Blood glucose at 98 milligrams per deciliter. At 1144 patient give Epinephrine using epi-pen. At 1145 patient on oxygen at 2L/minute.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,OTH,Lantus; Metformin two unknown blood pressure medication,Unknown,Diabetes and hypertension,,Iodine,"['Blood glucose normal', 'Chest pain', 'Dyspnoea', 'Headache']",1,MODERNA,IM 930791,IL,49.0,F,"Onset approximately 45 minutes to an hour after receiving, I began to feel very ""swimmy"" in my head, like I had consumed lot of alcohol in a short time. I felt a lot of pressure behind my nose, but not a stuffy nose. The woozy feeling also brought on some nausea. I felt like I couldn't focus, like I was in a daze or fog. This lasted throughout the following day. Left arm at sight of injection was sore starting 2 hours after shot, couldn't raise left arm x2 days. Still sore but manageable. I took a zofran for the nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Ritalin/Super C Complex/Bupropion/Valcyclovir/Cranberry,Urinary Tract Infection 3 weeks prior to vaccine,ADD,,Penicillin Sulfa,"['Disturbance in attention', 'Dizziness', 'Feeling abnormal', 'Injected limb mobility decreased', 'Injection site pain', 'Nausea', 'Paranasal sinus discomfort', 'Sensory disturbance']",1,MODERNA,IM 930792,WA,43.0,F,"One week after receiving the Covid vaccine, pt was seen by telemedicine in our clinic with symptoms of local cellulitis. The area was red, swollen and warm to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,none,none,none,,none,"['Cellulitis', 'Erythema', 'Skin warm', 'Swelling']",UNK,PFIZER\BIONTECH, 930793,AR,28.0,F,"Initially bleeding and swelling at injection site (believe it hit a blood vessel), immediately hit with a wave of dizziness, fast heart rate and tingling in throat. Since being home injection site has bruised and I have red streaking down the front of my arm with terrible pain and swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PHM,Prenatal vitamin Vitamin c Vitamin D3 Zinc,None,None,,No,"['Dizziness', 'Heart rate increased', 'Injection site bruising', 'Injection site haemorrhage', 'Injection site streaking', 'Injection site swelling', 'Pain in extremity', 'Peripheral swelling', 'Pharyngeal paraesthesia']",1,MODERNA,SYR 930794,IN,47.0,F,"Terrible headache for 19 hours which started 1 hour after shot. Headache again with heaviness 25 hours after shot including dizziness with bending. 35 hours after dose, had dull pain on the inside prominence of my right elbow (arm I got my shot). This pain lasted for 8 hours. Also accompanied with fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/08/2021,2.0,PVT,"Hydroxychloroquin, multivitamin, vitamin b12, vitamin d, iron, tylenol.",,"Sj�gren?s syndrome, herniated disc in neck",,Ibuprofen and Sudafed,"['Dizziness', 'Fatigue', 'Head discomfort', 'Headache', 'Injection site pain']",2,PFIZER\BIONTECH,IM 930795,IL,29.0,F,"fever 99.6 for 12 hours, soreness in upper arm and injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,none,none,none,,macadamia nuts,"['Injection site pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930796,GA,29.0,F,Day one left arm slightly swollen and sore. Day 2-3 redness present with soreness. small lump under skin. Headaches Day 4 redness growing in size (about size of quarter) with hard nodule under skin Day 5-10 enlarging redness (about 2.5inches by 2 inches diameter) dark red ring present with central clearing. Area is warm to touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,None,None,None,,Clindamycin,"['Erythema', 'Headache', 'Mass', 'Pain in extremity', 'Peripheral swelling', 'Skin warm']",1,MODERNA,IM 930797,OK,30.0,F,"Injection site swollen, tenderness, warm to touch, red, itchy, and pain when there is pressure.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/07/2021,8.0,PVT,None,Not ill.,No known health conditions.,,No known allergies.,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Ultrasound scan normal']",1,MODERNA, 930798,ID,53.0,M,"within 10 minutes of receiving vaccine, patient reported having neck tightness and chest tightness; patient was feeling warm and blood pressure was elevated; diphenhydramine 25mg was given and patient was taken to ER. ER reported it was a mix of a slight reaction and anxiety from receiving the vaccine. Patient was sent home from ER and is doing fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,,,,,,"['Anxiety', 'Blood pressure increased', 'Chest discomfort', 'Feeling hot', 'Hypersensitivity', 'Muscle tightness']",1,PFIZER\BIONTECH,IM 930799,HI,33.0,F,"Headache, bodyaches, and intermittent nausea and dry heaving peaking 26-32 hours post vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,,,,,,"['Headache', 'Nausea', 'Pain', 'Retching', 'SARS-CoV-2 test negative']",1,MODERNA,IM 930800,NY,71.0,F,Onset of tachycardia 5 minutes after injection which lasted 10-15 minutes. Resolved by itself.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,Premarin,none,none,,"Penicillin, shellfish, chocolate, lemon, cat hair, swordfish",['Tachycardia'],1,PFIZER\BIONTECH,IM 930801,OH,45.0,F,"Day 8 post vaccination a rash/hives developed under the injection site. Signs and Symptoms: redness, itching, swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,PVT,Metoprolol XL 25mg Daily,None,"Inappropriate sinus tachycardia, Asthma",,"Zithromax, Levaquin, Morphine","['Erythema', 'Injection site rash', 'Injection site urticaria', 'Pruritus', 'Swelling']",1,MODERNA,IM 930802,NJ,44.0,F,"Redness and itching on the left ear lobe and nose, lasted for about 1 hour and symptoms resolved on its own in 1 hour. Did not need to call physician.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"Atenolol, Sprintec,",None,hypertension,,None,"['Ear pruritus', 'Erythema', 'Nasal pruritus']",1,PFIZER\BIONTECH,IM 930805,FL,32.0,F,Large red area about 7 inches long and 4 inches wide with raised edges especially at bottom constant deep tenderness and armpit pain,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,01/08/2021,38.0,PVT,"Magnesium, panteprozole, metformin, saxenda, gabapentin, birth control, adderall, xarelto, integra,",,Lpr Prediabetic,,Sulfa drugs,"['Axillary pain', 'Erythema', 'Swelling', 'Tenderness']",1,MODERNA,IM 930806,AZ,36.0,F,"Itchy, hard, rough, burning",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/08/2021,8.0,PUB,Hydroxychloroquin Sulfasalazine Amlodipine Ibu,,,,Methotrexate,"['Burning sensation', 'Dry skin', 'Induration', 'Pruritus']",UNK,MODERNA, 930807,,31.0,F,"hyperthermia, tachycardia, chills, malaise, anxiety, sensitive skin/nerves, muscle and joint aches/pains.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,none,none,none,,none,"['Anxiety', 'Arthralgia', 'Chills', 'Hyperthermia', 'Malaise', 'Myalgia', 'Neuralgia', 'Sensitive skin', 'Tachycardia']",2,PFIZER\BIONTECH,IM 930808,ID,41.0,F,"0930 vaccine, and at 1030am (1 hour after vaccine injection) pt experienced red, hot rash from left deltoid injection site up to her neck. Pt states that she took Benadryl at 1230 and this rash and redness is now resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Injection site erythema', 'Rash erythematous']",2,PFIZER\BIONTECH,IM 930809,TX,47.0,F,"over 48 hrs after vaccination, significant erythema and edema of my injection site occured with tender skin. Expanded to approximately an area approximately 20 cm in diameter",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,WRK,"daily multivitamin, Vitamin D, ibuprofen, baby aspirin",none,"migraines headaches, vit D deficiency",,none,"['Injection site erythema', 'Injection site oedema', 'Injection site pain']",2,PFIZER\BIONTECH,SYR 930810,NY,43.0,F,"Fever, night sweat, headache, arm swelling, sore arm, extreme fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,UNK,None,None,None,,None,"['Fatigue', 'Headache', 'Night sweats', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,SYR 930811,WI,60.0,F,"Pfizer-BioNTech COVID-19 Vaccine Patient received Pfizer Covid-19 vaccine at 1043. Patient complained of tingling throat, no swelling noted. Patient alert, oriented and talking/answering questions appropriately. Voice noted to become hoarse with continued conversation. EMS alerted and took over care at 1107.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,WRK,,,,,,"['Dysphonia', 'Pharyngeal paraesthesia']",1,PFIZER\BIONTECH, 930812,NY,29.0,F,Body aches Chills Fatigue Tired Soreness in arm Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity']",1,MODERNA,SYR 930813,MN,37.0,F,"Sore arm for 72 hours Body aches, joint pain and fatigue starting at 27 hours post vaccination that lasted 12 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,WRK,None,No illnesses,"Anxiety /depression, hidradenitis suppurativa",,"Nickel, neomycin, framycin","['Arthralgia', 'Fatigue', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 930814,,31.0,F,"R shoulder/upper arm pain that began suddenly, gradually worsened from 7/10 - 10/10. Pain radiated to middle upper back. Nausea. Anxiety.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/29/2020,8.0,PVT,none,none,none,,none,"['Anxiety', 'Arthralgia', 'Back pain', 'Epistaxis', 'Pain']",1,PFIZER\BIONTECH,IM 930815,,37.0,M,"Started with headache then fatigue towards the end of the day. Overnight low grade fever, chills, severe myalgias and joint aches. In the morning nausea and dry wretching. Symptoms Vaccination was given around 10AM, Headache started immediately and the rest of them about 8-10 hrs later",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,None,None,,NOne,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Retching']",2,PFIZER\BIONTECH,IM 930816,MD,59.0,F,Hardness and warmth on 1/7/21 Redness noted on 1/8/21 at around 9:30 pm,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/07/2021,7.0,WRK,Omeprazole PO Zyrtec Vit. D Multi Vit Centrum,None,GERD,Flu vaccine Age 47 yo Hives two days after receiving vaccine Cannot recall brand name Date/year of event 2008,Flu vaccine ( hives 2 days after receiving) Ciproflixacin- Diarrhea and severe abdominal cramps,"['Erythema', 'Induration', 'Skin warm']",1,MODERNA,IM 930817,GA,41.0,F,"About 5minutes after vaccination had syncope episode, in and out for about 5-10, malaise, feeling like ? under anesthesia since then.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,None,None,None,,None,"['Malaise', 'Syncope']",1,PFIZER\BIONTECH,IM 930818,ID,41.0,F,"Within 1 hour of vaccine injection, she developed a red, hot rash traveling from injection site in left deltoid up her neck. She took Benadryl 2 hours later (1230) and this reaction is absent now.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Injection site erythema', 'Injection site rash', 'Injection site warmth']",2,PFIZER\BIONTECH,IM 930819,CT,,F,"Received first dose of Pfizer vaccine @ 4:30PM 12/28/2020. Full body rash starting @ 7:30PM day of injection lasting until today (Jan 8th 2021) although much less severe. Rash was hot to touch, not itchy, and very blotchy first few days. Dec 30-Jan 5 2021 low grade fever, chills, diarrhea, sore throat. Thought possibly COVID+; tested Dec 31 @ Hospital and was negative. No other allergic reactions such as throat swelling, itchiness, eye irritation at all. Alough I did take one Benadryl at ~9PM 12/28.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,,,PVT,"Adderall 10mg, Junel FE birth control pill, IV ketamine","treatment resistant major depression, ADHD","treatment resistant major depression, ADHD",,"Oral allergy syndrome (allergy=raw fruits, vegetables, & nuts)","['Chills', 'Diarrhoea', 'Oropharyngeal pain', 'Pyrexia', 'Rash', 'Rash macular', 'SARS-CoV-2 test negative', 'Skin warm']",1,PFIZER\BIONTECH,IM 930820,MO,36.0,F,Individual presented with a rash on her torso. It didn't look like hives--more like lines. Said she did not remember seeing this rash prior to receiving the Moderna vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,SEN,Non known,Non known,Non known,,Non known,['Rash'],1,MODERNA,IM 930821,OK,37.0,F,fever dizziness headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,WRK,PNV VITAMIN C ZINC EPINPEN PROAIR VIT D3 Vit E Aspirin Montekulast Pepcid Doxepin Sertralin Fluticasone,,Allergies severe Chronic Sinusitis Atrial fibrillation,,Pecan,"['Dizziness', 'Headache', 'Pyrexia']",1,MODERNA,IM 930822,ID,29.0,F,"Patient is a 29 y.o. year-old female that presented to the clinic today for a Moderna COVID-19 vaccine.� Moderna COVID-19 vaccine was administered at: Time: 1820 Date: 1/8/2021 � Patient presented with symptoms at time 1837. Patient's symptoms include the following: � Skin and Mucosal symptoms: Yes: Swelling of the throat and nose. Patient states that her nose started to feel funny and her throat was tight. She also noticed that her arm was red and swollen. � Respiratory Symptoms: No � Gastrointestinal Symptoms: No � Cardiovascular: No � The following actions were performed: Bendaryl 25mg administered as a single dose, patient brought to exam room by RN & MA. Vitals taken every 5 minutes while monitoring patient condition. At 1849 patient reported that her throat was feeling better. Patient had a localized reaction at the site of injection Left upper arm including redness, swelling and warm to touch. At 1903 RN reevaluated patient and reports that her redness is decreasing in her left arm and the throat/nose numbness was getting better. PA-C came into the room and evaluated patient. She said she sounds good and did not appear to be in distress. Patients husband drove her home after patient was monitored for approximately 40 minutes. Prior to patient leaving clinic RN advised patient of the 911/emergency room protocol . Patient verbalized understanding and was escorted out by RN to her car. � Incident reported to VAERS and database report completed � 1/8/2021 �",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Erythema', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Intranasal hypoaesthesia', 'Local reaction', 'Nasal congestion', 'Peripheral swelling', 'Pharyngeal swelling', 'Throat tightness']",1,MODERNA,IM 930823,MI,30.0,F,"Fatigue, body aches, chills, very sore site extremity all last about 24 hours, rigid neck, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Effexor,No,No,,No,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Nuchal rigidity', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 930824,MN,50.0,F,"1000 - Jan 6, I am a nurse, I was with a patient when I had to remove myself from patient care, as I was light-headed and dizzy and nausea. I took a Zofran to relief my intense nausea. I went home and slept for 2 hours. Also had body aches and a fever of 100.4 Temporally, and Chills. I ate little that night and went to bed as intense fatigue took over. I woke the next morning, and felt fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"Synthroid, Progesterone, Multivitamin, Vitamin B-Complex, Calcium+Vitamin D, Magnesium, Fish Oil,",None,"Auto-Immune, Rheumatoid Arthritis, Sjogrens, Lupus, Menopause",,"Sulfa, EES","['Chills', 'Dizziness', 'Fatigue', 'Impaired work ability', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 930825,CA,32.0,F,"Redness, itching, swelling, hard lump and hot to touch around injection site 8 days after vaccine was administered. Swelling/hard lump grew twice in size in 48 hours. PCP stated this is probably an delayed localized immune reaction of hives.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,WRK,Advair 2x daily,No,Asthma,,No,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Urticaria']",1,MODERNA,IM 930826,GA,35.0,M,"Events of 7 Jan 21 (~15 hrs after first dose) 0600 - woken by cold chills/shivering 0800 - chills subsided, but tingling sensation similar to drinking a large energy drink (ie. Monster) 1000 - muscle and joint aches throughout body, mild chills, very fatigued 1200 - headache begins. No change to muscle/joint pain, chills, or fatigue. Take ibuprofen for pain 1400 - peak of all pain and fatigue with massive headache, shivering chills and tingling throughout surface of skin. Very hard to focus on tasks. 1600 - most of the pain has gone away and barely noticeable. Headache, chills and tingling have mostly gone away. 1800 - all prior symptoms cleared. Only thing remaining is soreness where vaccine was injected. 8 Jan 21 0730 - After 9 hours of sleep, all symptoms remain cleared. 2200 - all symptoms remain cleared. Injection site soreness barely noticeable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,MIL,Clobetasol cream - as needed,None,Good health,,None,"['Arthralgia', 'Chills', 'Disturbance in attention', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Paraesthesia']",1,MODERNA,SYR 930828,VA,22.0,M,Headache. Nausea. Chills. Fatigue. Exhaustion. Vomiting. Joint pain. Lasting over 24 hours so far.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,,,,,Amoxicillin,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,SYR 930829,AZ,52.0,M,24 hours after injection fever began. Also Experienced chills and headache. 36 hours after injection fever peaked and then broke. 40 hours after injection symptoms subsided.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,None,None,None,,None,"['Chills', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 930830,GA,40.0,F,"Going to bathroom constantly, arm sore and swollen with a big knot/ more like a circular bruise, fever as if I had covid19 again, weak",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,,,Asthma,,Tomatoes and raspberries,"['Asthenia', 'Nodule', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 930832,NY,56.0,M,Itchiness starting with both hands front and back on day 7 progressing to itchiness to top of both feet and both elbows. Noticeable raised red lesions on day 9. Cortisone cream and lidocaine cream minimally effective. Will try one Benadryl cap before bed. Will consider pcp office visit if sx do not resolve by Monday (day 14).,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,OTH,Gabapentin 100 mg hs Tamsulosin 0.4 mg daily Docusate sodium 250 mg daily Zyrtec 10 mg daily Magnesium 100 mg daily Fish oil 1-2 daily,None,None,,Vicodin Percoset Penicillin,"['Erythema', 'Pruritus', 'Skin lesion', 'Swelling']",1,MODERNA,IM 930833,IN,23.0,F,Symptoms Lasted 12 hours: Achy Fever 99.5 headache sensitive to light cold but felt hot Took Tylenol to help with symptom,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,,N?A,,,,"['Feeling hot', 'Headache', 'Pain', 'Photophobia', 'Pyrexia']",1,MODERNA,SYR 930834,,59.0,F,"Developed severe chills, body aches, mild fever of 100.5. Lasted about 30 hours. Treated with Tylenol. Had to miss a day of work. Have lingering fatigue and headache after 2 days. Also morning after vaccination had about 5 minutes of tachycardia with HR of 165 bpm. Resolved after taking blood pressure which was 114/69 with HR of 85 bpm. No further episodes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Vit D, B12, flaxseed oil",None,None,,Cephalosporins (rash) Sunblock( hives) activated by sun exposure Grass (hay fever),"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia', 'Tachycardia']",2,PFIZER\BIONTECH,IM 930836,GA,57.0,F,"Elevated heart rate, shortness of breath, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,PUB,"Xanax, trazadone, Resterol",Sore throat,Fibromyalgia,,,"['Dyspnoea', 'Headache', 'Heart rate increased']",1,PFIZER\BIONTECH,SYR 930837,OH,30.0,F,"I know this is NOT a ""live vaccine"" but i did turn up positive for covid on 1/4/2021. my menstrual was delayed after shot by 2 days which is usual for me.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/31/2020,2.0,UNK,,,,,,"['COVID-19', 'Menstruation delayed', 'SARS-CoV-2 test positive']",1,MODERNA,IM 930838,IN,79.0,M,Elevated Temp 100.2,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,SEN,,,,,,['Body temperature increased'],UNK,MODERNA, 930839,OH,35.0,M,"Confusion, disorientation, memory loss, nausea, vomiting, brief episode, approximately 2 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/08/2021,11.0,PVT,Vitamin C,No,No,,Not that I?m aware of,"['Amnesia', 'Confusional state', 'Disorientation', 'Nausea', 'Vomiting']",1,MODERNA,IM 930841,AK,54.0,F,"Severe bilateral headache and chills with nausea and unlike any headache I have ever had. Treaty with Goody headache powder, 2 vicodin and 16 hours of sleep. Outcome, it went away though I missed a day of work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,OTH,armour thyroid 240 mg and irbesartan 300 mg,none,high blood pressure and removal of thyroid for thyroid cancer,,none,"['Chills', 'Headache', 'Nausea']",1,PFIZER\BIONTECH,IM 930842,AR,38.0,F,"Fever, injection site tenderness, body aches, joint pain, severe headaches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,Tylenol Took hydrocodone a couple days prior to vaccine Zyrtec,Allergies/ congestion Had a dental implant rod placed 3 days prior to vaccine but did well post placement,Asthma,,Sulfa drugs,"['Arthralgia', 'Fatigue', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 930844,IN,77.0,F,Elevated Temp 100.2,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,SEN,,,,,,['Body temperature increased'],UNK,MODERNA,IM 930845,NM,26.0,F,Headache Body ache Fatigue Painful soreness at the injection site Swollen lymph nodes on arm of injection site - painful sore ness Chest pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Vitamin C Zinc Magnesium Tylenol Vitamin B,None,None,,Amoxicillin Codeine,"['Abdominal distension', 'Chest pain', 'Fatigue', 'Headache', 'Injection site pain', 'Pain']",2,PFIZER\BIONTECH,SYR 930846,WI,44.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Given at Hospital L upper arm has been achy / painful at injection site and has not gone away, gets worse with some motions, has not been red or swollen Makes dressing, reaching, dishes, laundry, putting on a backpack, working with patients all painful (I am a physical therapist in the hospital) I have an old injury to the long head tendon of my biceps in the L arm and originally thought it just flared that up for some reason, but the pain is also more lateral by the injection site I have been resting it, trying not to aggravate it, using some tylenol as needed for sleeping as positioning is hard lately, and it's been hurting more towards the end of the day It is not getting better, and I feel like may be getting a little worse. I am going to start icing it this weekend too. It is starting to affect how I do my daily activities and my job - I am considering going to the doctor",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,"women's multivitamin, 1000 mg Vit D daily, metformin, levothyroxine, omeprazole, Claritin, Zyrtec, duloxotine, losartan, simvastatin, sumatriptan, topiramate, letrozole, norethindrone acetate, miconazole powder, tylenol, ibuprofen, miralax","tested negative for COVID-19 on Saturday Dec 26th (tested d/t sore throat, stuffy head, headache, fatigue)","migraines, hypothyroid, thrombophelia, factor V leiden heterozygous, OSA, dysmenorrhea, menometrorrhagia, connective tissue disorder, chronic pain, chronic fatigue, adneomyosis, endometriosis, DM II",,none,"['Injection site pain', 'Loss of personal independence in daily activities', 'Pain in extremity', 'SARS-CoV-2 test negative', 'Sleep disorder']",1,PFIZER\BIONTECH,IM 930847,CT,78.0,M,"Sore injection site, fever, chills,extreme muscle fatigue 24 hours after injection. Full ?recovery ? by 1/8(Friday)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"Prednisone5 mg, Ubiquinol,Turmeric,Folic acid,Calcium,ToprolXL,Xarelto ,Zetia,Niacin,Lasix,Atorvostatin PLUS. Keytruda infusion every 3 weeks",Dermatomyocitis and lung cancer,See item 11,,None,"['Chills', 'Injection site pain', 'Muscle fatigue', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 930848,TX,33.0,F,Anaphylactic shock. I was sent to the hospital. They weren?t able to get me stable at the clinic even after the epi pen injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,,,,,,['Anaphylactic shock'],UNK,MODERNA,IM 930849,,23.0,F,"Three hours after I received the vaccine, I began to feel extremely tired and had a headache. Five hours after, the injection site had a pinkish color and felt sore. Then it was difficult to move my arm due to the soreness that traveled from my right upper arm to my right shoulder. I went to bed after taking Tylenol due to the headache and body aches. I woke up on 01/08/2021 with a severe migraine and general body aches. I took Tylenol in the morning and spent the day sleeping due to the migraines, malaise, and body ache. Throughout the day, I also experienced hot flashes and minimal nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,,,,,,"['Fatigue', 'Headache', 'Hot flush', 'Injection site discolouration', 'Injection site pain', 'Malaise', 'Migraine', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 930850,WA,44.0,F,"Injection site was red, swollen/raised, itchy, painfull thru to today 01/08/2021. Bodily reactions are achy, fatigue, drowsy, headaches, mild temp up to 100.0 (01/07/2021). As of 01/04/2021, other than temperature differences, my other bodily symptoms we minimum to none. But the injection site reaction continues. Originally the symptoms started about 2.5hrs post injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Daily: 1500mg Gabapentine, 450mg Buproprion, 200mcg Levothyroxine, 6000iu Vitamin D3, 1950mg Calcium Citrate, 50mg Nortriptyline, 2.5mg Eliquis, Fluticasone spray, 10mg THC","None, other than still healing from nonunion reconstructive foot surgery (8/14/2020)","Mild asthma, L5S1 Herniated disc Sciatic nerve root impingement, Hemiplegic Migraines, Arthritis",,"Penicillin, Amoxicillin, Sumatriptan, Butabarbital, Chlorine, Bleach","['Body temperature increased', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Pain', 'Somnolence']",1,MODERNA,SYR 930851,IN,90.0,F,Elevated Temp 100.6,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,SEN,,,,,,['Body temperature increased'],UNK,MODERNA, 930852,UT,32.0,F,"About 10 minutes after getting the Modena vaccine my face started getting numb. The most predominant area is my forehead and right side of my face, and the corner of my mouth. At the dr office a rash was also noticed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,Albuteral but wasn't used day of vaccination,,Asthma,,,['Hypoaesthesia'],UNK,MODERNA, 930853,MI,52.0,F,"Developed fever, body aches, headache, uncontrollable shivering within 12 hours of administration. This lasted 72 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PHM,None,None (Had Covid infection mid November),None,,Cefzil,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 930854,NV,50.0,F,"First three days had a solid lump on left area and felt fatigue, muscle soreness and low grade fever. Went to work for three days still feeling fatigue and took the last two days off because I still have fatigue, muscle soreness and now a really bad headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,"Oxcarbazipine, Fluoxetine, Montelukast, Amitriptyline, Magnisium, Probiotic, Claritin, Vitamin D 3, Vitamin C, Cranberry, Biotin,.","Tested positive for COVID 19 on November 20, 2020","Seizures, result of brain tumor removal in 2011. Angiogram left me permanently blind in right eye.",,"Penicillin, Morphine, Oxycodone,","['Fatigue', 'Headache', 'Impaired work ability', 'Mass', 'Myalgia', 'Pyrexia']",1,MODERNA,SYR 930855,NY,54.0,F,"Starting on the second day after vaccine I started to get itchy, first my arms and back and eventually all over. On the third day I started to see pumps on my itchy skin. I started to take benadryl 25mg on the 26th and 27th. Doubled the dose to 50mg at night time for 5 days. Took medicated baths and Sarna cream, along with benadryl cream. The symptoms started to subside. I took only benadryl 25mg on January 2nd and 3rd. Now I am still somewhat itchy but only using topical creams. I do have seasonal eczema and dry and itchy skin in the winter but this was definitely something more than my winter symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,PVT,"Vit D, Vit C, Zinc",NONE,NONE,,NONE,"['Pruritus', 'Rash', 'Vaccination complication']",1,PFIZER\BIONTECH,IM 930856,NC,42.0,F,"Severe Chills when I went to bed the night after the injection . On and off fever the next day of vaccination. Took Tylenol (2) 500 mg every six hours , 3x that day. Fever was gone the second day after vaccination, slight chills that night.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,"Tamoxifen Citrate 20 mg, vit B complex, vit D, zinc, vit C, fish oil, tumeric curcumin, vit E, biotin, probiotic , multivitamin, elderberry",None,"Breast cancer survivor, currently on remission",,None,"['Chills', 'Pyrexia']",1,MODERNA,IM 930858,WI,42.0,F,01/07/2021 - Woke up at 10AM with pulsing pains in left side of chest. I took asprin and it went away. 01/08/2021- Woke up at 11AM with slight pulsing pains again in left side of chest. no medicine taken. It came and went as the day went on - felt similar to heartburn. Thought I should report cause I've never woken up with these pains prior to this.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,WRK,Trazadone for sleep previous night,no,,,red dye,['Chest pain'],1,PFIZER\BIONTECH,IM 930859,OR,44.0,F,"Migraine with auras (no previous hx of auras), currently for 2 days and ongoing. OTC meds and rizatriptan having no effect",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,"Quetiapine, Valbenazine, Adderall XR",None,"ADHD, tardive dyskinesia",,Lamotrigene,"['Migraine', 'Migraine with aura']",1,PFIZER\BIONTECH,IM 930860,KY,45.0,F,I started having flushing within a minute of receiving vaccine next I noticed I had heart palpitations I was told my skin was clammy then I had another episode I was taken to ER and decardron was given. I was observed in ER for few hours . Since that day I have heart palpitations every day along with chest pain sometimes I am not able to wean off steroids I also had diarrhea on 1/3 that lasted few days . These side effects are very scary every day heart palpitations I feel my heart would stop,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,Prednisone 2.5mg Allegra Bisoprolol Hydroxychloroquine Neurontin,No I started having flushing and heart palpitations immediately after vaccine I was given decadron in ER and observed for few hours. It has been three weeks I am not back to normal . I have heart palpitations every day sometime with chest pain. I am not able to come off steroids since then . I stopped hydroxychloroquine few days ago due to palpitations I also had mild diarrhea started on 1/3 and stayed few days,"I had cosackie infection feb 2019, I was bedridden for 3 months with chest pain, fatigue , palpitations I was treated for possible pericarditis and also given diagnosis of chronic fatigue syndrome . Since then I have been on steroids off and on negative autoimmune work up. Last time I had palpitations June 2020",,Amoxicillin Zithromax,"['Chest pain', 'Cold sweat', 'Diarrhoea', 'Electrocardiogram normal', 'Flushing', 'Palpitations']",1,PFIZER\BIONTECH,SYR 930861,NY,48.0,F,48 hour after vaccine still have low grade fever,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,Tamoxifen Blood pressure meds Water pill,None,,,Coding Penacilin,['Pyrexia'],1,MODERNA,SYR 930862,LA,39.0,F,"4 days after receiving vaccine, was awoken from sleep with high pitched tinnitus in right ear. I discovered in the morning that i could not hear out of that ear. My husband, a physician, examined ears and did not see any effusion. Consulted with a friend who is an ENT specialist, and he recommend initiating high dose steroids immediately. 2 days later, had audiology test in ENT office, and it revealed severe Sensiorneural hearing loss in right ear. The steroids were continued, and valtrex was added. I had MRI of head on 1/7/20 which did not reveal any abnormality.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,PVT,None,None,None,,None,"['Acoustic stimulation tests abnormal', 'Deafness', 'Deafness neurosensory', 'Magnetic resonance imaging head normal', 'Tinnitus']",1,PFIZER\BIONTECH,IM 930863,NY,39.0,F,"Arm started to itch a little and then swell up at the injection site with warmth, redness and arm pain. It initially lasted 5-6 days and the arm pain and redness lessened and now 8-9 days later it swelled up bigger, redder. More painful and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"Metformin, simvistatin",,DM and cholesterol,,Grass allergies,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity', 'Pruritus']",1,MODERNA,IM 930864,ME,37.0,F,"Fever, chills, body aches, severe headache, nausea, vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Prenatal vitamins Citalopram,None,Anxiety,,None,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,SYR 930866,TX,39.0,F,"Vagal presyncope. Tachycardia. Cold sweat, lightheadedness about 15min post injection. Having had multiple vagal episodes before, including with other vaccines, I oncreased my SVR by kneeling down. Symptoms resolved after 15min of continuous kneeling.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,"Allegra, Albuterol, Vitamin C, Vitamin D, Zinc, Loestrin",None,"Asthma, chronic idiopathic uritcaria, ezcema, history of multiple episodes of vasovagal presyncope/syncope","Japanese encephalitis, typhoid - given at same time - vasovagal syncope. Yellow fever - large indurated location reaction with l","Pollen, dander, dust mites, mold, horse, cat, benzoyl peroxide, cold temperature, pressure","['Cold sweat', 'Dizziness', 'Syncope', 'Tachycardia', 'Vascular resistance systemic increased']",1,PFIZER\BIONTECH,IM 930867,TX,33.0,F,Tachycardia and lightheadedness occurred about 10 minutes after injection and lasted for about 30 minutes,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,"Omeprazole, Candesartan, Metamucil, birth control, xyzal, folic acid, melatonin, magnesium, B12, Flonase",Chronic migraines,Chronic migraines,,None that I was aware of before vaccination,"['Dizziness', 'Tachycardia']",1,PFIZER\BIONTECH,IM 930868,NM,58.0,F,"Sudden onset headaches, high blood pressure, and vomiting two hours after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PHM,"potassium chloride, aspirin, beclomethasone, fluticasone, albuterol, omeprazole, atorvastatin, gabapentin, hctz, linsinopril, tramadol, tizanidine",NONE,"asthma, HTN, hyperlipidemia, GERD, chronic neck pain, arthritis, fibromyalgia, neuralgia",,codeine,"['Headache', 'Hypertension', 'Vomiting']",1,MODERNA,IM 930869,CA,50.0,F,She has a fever of 101.5 chills shakes eyes sensitive to light severe headache body and muscles ache weak fatigue mild neasua,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,OTH,None,No illness at time of shot But had. Coved =19,Heart murmur,,Yes,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Photophobia', 'Pyrexia']",1,MODERNA,SYR 930870,NY,29.0,F,Diagnosed with Shingles,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PUB,"Plaquenil, Levothyroxine, omeprazole, Procardia, flinstones chewable vitamins, b12, biotin, vitamin d, emergen-c.",,Rheumatoid Arthritis,,NKDA,['Herpes zoster'],1,MODERNA,SYR 930871,TX,37.0,F,"A large (half dollar size), raised hive appeared to the right of my injection site. I do get hives but never on my arm and they disappear within hours. This one persisted for hours and left a faint red spot 24 hours later. It is no longer raised.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/07/2021,8.0,OTH,Lexapro Lipitor Daysee,,High cholesterol,,Sulfa drugs,"['Injection site erythema', 'Injection site urticaria']",1,MODERNA,SYR 930872,IL,29.0,F,"Moderna COVID-19 Vaccine EUA Started with a headache around 9pm. Severe arm pain around injection site. Body chills and then body sweats. Restless sleep. By 6am still had a headache and nauseous. Slept until 11am, awoke with a severe headache and light sensitivity and some nausea. Slept from noon until 3pm and had a slight headache. Headache has been off and on and is present but manageable at time of this report.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,"Vitamin D, zinc and calcium, and a probiotic taken at 8am that day.",,,,Cefzil Zithromax Bactrim,"['Chills', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Nausea', 'Photophobia', 'Poor quality sleep']",1,MODERNA,SYR 930873,OR,40.0,F,"Fever, muscle/body aches. Stiff neck Arm VERY sore. Woke up the night after receiving with cold sweats and arm throbbing (like someone punching repeatedly in the arm) and sensitive to tje touch. Arm painful for 3-4 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Na,Na,Na,,Chlorhexadine,"['Cold sweat', 'Musculoskeletal stiffness', 'Myalgia', 'Pain', 'Pain in extremity', 'Pyrexia', 'Sensitive skin']",1,PFIZER\BIONTECH,IM 930874,LA,30.0,M,"Itching on the tops and sides of feet, on kneecaps, backs of hands, under armpits, and on chest/torso",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,"Biktarvy, Lipitor, fenofibrate, Valium, Adderall, Toprol, nexium, singulair",,"HIV, hypertrophic obstructive cardiomyopathy",,Latex adhesive,['Pruritus'],1,MODERNA,IM 930875,HI,34.0,F,"Given by DOH, immediate itching/palpitations medics sent her for evaluation tachycardic, a few hives on right cheek, wheezing no hypotension Given benadryl 25 mg IV, famotidine 20 mg IV with prompt resolution of sympotms Observed and discharged on oral anti histamines",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Cetirizine,,"eczema, asthma",,"Shellfish, late","['Immediate post-injection reaction', 'Palpitations', 'Pruritus', 'Urticaria', 'Wheezing']",1,MODERNA,IM 930876,TX,88.0,M,Death,Yes,01/08/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PHM,,,Prostate Cancer,,,"['Death', 'X-ray with contrast']",1,MODERNA,IM 930877,NM,20.0,F,"Excessive itchy skin over thighs, gluteal region, and knees",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,UNK,Sertraline,COVID-19,,,,['Pruritus'],1,MODERNA,IM 930879,TX,41.0,F,"Ipsilateral anterior axillary swelling/lymphadenopathy, beginning ~24 hours after administration, limiting L arm ROM x3 days. I was unable to lower my arm fully, and had significantly impaired movement due to pain and swelling. It is Improving as of report date, but still present (ROM essentially back to normal, only tender to palpation)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Dexilant, Advair, Wellbutrin, meloxicam, cyclobenzaprine, ambien, Trulance",None,"Asthma, axial spondyloarthritis, ehlers danlos type 3, CIC, anxiety",,"Penicillin, latex, baclofen, sulfa, oxycodone","['Hyperaesthesia', 'Laboratory test normal', 'Lymphadenopathy', 'Mobility decreased', 'Pain', 'Tenderness']",2,PFIZER\BIONTECH,IM 930881,AZ,19.0,M,"At time of vaccination ~5 minutes after the injection of the pfizer vaccine I developed a tightness in my throat, I was still waiting in line and I did not think much of it, therefore I did not alert the medical personnel about the reaction. Approximately @15mins after the injection I left the site and developed a sense of something wrong and did not feel ""right"", my chest became tight, hoarseness in my throat and speach, lightheaded, and I remember taking a sip of my coffee thinking it was more difficult to swallow than usual. May I note I was in the passenger seat and not driving the vehicle. I alerted my mother of the reaction, both sceptical because of my hx of no known allergies. We both figured as long as I can breath and I was still conscious, with no signs of cyanosis I would be fine. At around 10:45 I took my BP: which was 106/62 I typically run low. I then took two 25mg Benadryl capsules which did help the throat tightness to an extent, however the tightness in the chest, lightheaded and dizziness still persisted. I was aware of the potential for Bi-phasic anaphylaxis so we had an Epi-pen on stand by just in case. I was stable for the rest of the day. At approximately 10pm I did notice a small erythematous non-pruritic rash across my chest. The symptoms of the reaction did subside within 24hrs. I remained in stable condition and recovered with time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,OTH,None.,None,None,,None,"['Chest discomfort', 'Dizziness', 'Dysphagia', 'Dysphonia', 'Malaise', 'Rash', 'Rash erythematous', 'Throat tightness']",1,PFIZER\BIONTECH,IM 930882,CA,33.0,F,"Red, blotchy, hot to touch, itchy. Ongoing symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,"Post-natal multivitamin, fluoxetine 10mg, biotin & collagen gummies, green tea pills,",None,None,,"penicillin, azithromycin, fragrances","['Erythema', 'Pruritus', 'Rash macular', 'Skin warm']",1,MODERNA,IM 930883,ID,40.0,F,"Day8 after vaccine, lymph nodes in armpit of same arm that had vaccine became enlarged, tender. Injection site became red, burning, itching, and covered majority of deltoid.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,Adult Multivitamin Gummy daily,None,None,,None,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Lymphadenopathy', 'Tenderness']",1,MODERNA,IM 930884,MD,28.0,F,"Day 1 - Soreness at injection site (left deltoid) Day 2 - Soreness at injection site (left deltoid), fatigue, bilateral lymph nodes below ear and behind jaw sore Day 3 - Soreness subsiding, fatigue Day 4 - Soreness to injection site absent; lymph node(?) soreness and pain lateral chest/breast area anterior to axilla Day 5 - Soreness to lymph node remains Day 6 - Soreness to lymph node subsiding Day 7 - Soreness to left deltoid returned. Day 8 - Large flat area of erythema around and below injection site appeared, hot to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,PVT,None,None,None,,Augmentin and Clindamycin (hives),"['Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Lymph node pain']",1,MODERNA,IM 930885,,48.0,F,"Severe dizziness for about an hour with Temperature 100.4 while alternating Tylenol and Motrin that started about 27.5 hours after receiving vaccine. Temperature decreased to 99.4-99.7 and lasted for 2 days after. Pain in both hips, skin hurt to touch on back, headache, slight runny nose, malaise, and back pain lasted all day the second day after vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,MIL,,,,,Allergy to Adhesives and Tape,"['Arthralgia', 'Back pain', 'Body temperature increased', 'Dizziness', 'Headache', 'Malaise', 'Pain of skin', 'Rhinorrhoea']",1,MODERNA,IM 930887,KY,33.0,F,"Tightening of throat, itchiness in throat, dizziness, confusion, light headed, increased heart rate. Emergency room treated me with steroid, Benadryl, and epinephrine. I was sent home with a steroid pack, Benadryl, and an epipen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,spironolactone 100mg (for acne),None,None,,Penicillin,"['Confusional state', 'Dizziness', 'Heart rate increased', 'Throat irritation', 'Throat tightness']",1,MODERNA,SYR 930888,CA,55.0,F,"High fever 101degF for 36 hrs, headache, muscle pain, joints pain, stomach discomfort. Took Tylenol every 6 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,"Vitamin C, vitamin D3, zinc",None,None,,None,"['Abdominal discomfort', 'Arthralgia', 'Headache', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH,UN 930889,MN,48.0,M,"I had a myocardial infarction on December 27, 2020. I had received my first vaccination for COVID-19 on December 22, 2020. Not sure if these are related but I felt I should report it.",Not Reported,,Yes,Yes,3.0,Yes,Y,12/22/2020,12/27/2020,5.0,PVT,"Propranolol, Pepcid,cetrizine, losartan",None,"HTN, allergies",,Nkda,"['Angioplasty', 'Coronary artery occlusion', 'Electrocardiogram ST segment elevation', 'Myocardial infarction', 'Stent placement']",1,PFIZER\BIONTECH,IM 930890,NJ,60.0,F,Headache & Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,PVT,,,,,,"['Headache', 'Pyrexia']",1,PFIZER\BIONTECH,IM 930891,CA,48.0,F,"1 week after receiving the vaccine I developed cellulitis in the injection site. I went to my primary care, and was prescribed keflex for 7 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/06/2021,6.0,WRK,"Bcp, albuterol, qvar, fish oil, calcium, multivitamin, collagen, turmeric",None,"Photosensitivity, asthma",,None,['Injection site cellulitis'],1,MODERNA,IM 930892,GA,57.0,F,"Approx 20 mins after vaccination, just after leaving observation, pt began to complain of itching at scalp. She mentioned this to one of the vaccination nursing staff. This author arrived as discussion was taking place. Itching increasing to torso, began coughing. Denies dyspnea. Placed in wheelchair and taken to ACC without delay. ACC notifed of arrival and was taken directly to Triage. Arrival vitals: 131/85 81 98.5 R- 20 SPO2= 99 RA At ACC - treated with: - Benadryl 25mg IV - Famotidine 20mg IV - Solumedrol 125mg IV - Albuterol Inhaler Improved after meds.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,No routine meds. Meds administered today after reaction: Medication Administration from 01/08/2021 1331 to 01/08/2021 1647 Date/Time Order Dose Route Action Action by 01/08/2021 1404 diphenhydrAMINE Inj 25 mg (BENADRYL) 25 mg intraVENOUS,Migraines,,,"Morphine, Percocet, Percodan","['Cough', 'Pruritus']",1,PFIZER\BIONTECH,IM 930893,NY,27.0,F,"Right side of face (specifically lips) extremely swollen. Begun at 5am following morning following previous day 11:20 am injection received. Face swollen, left arm could not lift (at all), body temp rise to 101.1, pulse oximeter dropped to main number 73 number to right (small) 76- numbers were 95 + 98 2.5 weeks prior when positive for covid. Could not move without feeling dizzy/weak,extreme fatigue, slept for 18 hours day following injection when symptoms began. Face swelling (lips increased) 2 doses (2 pills per dose)4 hours apart of Benadryl did not reduce swelling. PC prescribed prednisone & took 4 pills initial dose (day 1), swelling decreased within 6 hours. Following day - extreme fatigue, stomach ache, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,UNK,"Sublocade injection monthly, gabapentin 600 mg X3 per day, adderal 20 mg X 1 per day",Covid - 2.5 weeks prior,"Nerve damage, autoimmune possible underlying tbd pending referral",,None,"['Abdominal pain upper', 'Asthenia', 'Body temperature increased', 'Dizziness postural', 'Fatigue', 'Injected limb mobility decreased', 'Lip swelling', 'Nausea', 'Oxygen saturation decreased', 'Swelling face']",1,MODERNA,SYR 930894,GU,75.0,M,"Low grade Fever, headache needing admission Intracranial hemorrhage with hypertension Medical management for hypertensive emergency Received surgical evacuation admitted in Intensive care,",Not Reported,,Yes,Yes,,Not Reported,U,12/29/2020,01/02/2021,4.0,PVT,Not on medications,Hypertension,Hypertension,,Possibly penicillin,"['Blood pressure increased', 'Brain herniation', 'Computerised tomogram abnormal', 'Computerised tomogram head', 'Haemoglobin increased', 'Haemorrhage intracranial', 'Headache', 'Hypertension', 'Hypertensive emergency', 'Hypotonia', 'Intensive care', 'International normalised ratio normal', 'Intracerebral haematoma evacuation', 'Platelet count normal', 'Pyrexia', 'Shift to the left', 'White blood cell count normal']",UNK,PFIZER\BIONTECH, 930896,OR,35.0,F,"Induration/swelling, redness, itching at injection site. Blotchy rash down left arm and up left shoulder. Itchy throat. Wheezing. Cough. Started 7 days after vaccine administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,WRK,Quetiapine Adderall Norethindrone Vitamin D Cetirizine Omeprazole,Asthma,,,Penicillin- rash Citrus foods- rash in mouth,"['Cough', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Rash', 'Rash macular', 'Throat irritation', 'Wheezing']",1,MODERNA,IM 930897,UT,48.0,F,"Shortness of breath, cough, rash on face and neck, arthralgia",Not Reported,,Yes,Not Reported,,Not Reported,U,01/01/2021,01/07/2021,6.0,WRK,"Liothyronine, levothyroxine,losartan,escitalopram, buspirone, gabapentin, vitamin d, iron, multivitamin",Currently being tested for autoimmune diseases,"Hypothyroidism, hypertension, chronic pain, osteoarthritis, depression",,"Lortab, had an allergic reaction to potassium citrate when tested for an N95 mask;dogs, cats, rabbits, some trees and weeds","['Arthralgia', 'Cough', 'Dyspnoea', 'Rash']",2,PFIZER\BIONTECH,SYR 930898,TX,50.0,F,"States she is not feeling good about 5-10 minutes after shot. States she has burning in chest(points to esophageal area up and down mid chest). Also pale and diaphoretic. Nausea. Cool wet rag and cool air provided. Felt bad for about 10 minutes: BP at this time 240/80. 20 minutes later, systolic BP had returned to normal. She acknowledged that she did not like shots but had not ever responded like this. Released home after 30 minute observation ad symptoms totally resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,"high blood pressure, obesity",,none acknowledged,"['Blood pressure systolic abnormal', 'Chest pain', 'Feeling abnormal', 'Hyperhidrosis', 'Nausea', 'Pallor']",UNK,MODERNA,IM 930899,OH,57.0,F,Fever chills body aches for 2 days was taking Motrin and Tylenol Tired since vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Vitamin b Vitamin D Baby ASA Zinc,December 4th positive fir Covid,None,,PCN,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",UNK,MODERNA,SYR 930900,AZ,50.0,F,NONE,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,,,OTH,NONE,NONE,NONE,,NONE,['Unevaluable event'],UNK,PFIZER\BIONTECH,SYR 930901,GA,32.0,F,"Severe migraines starting around 36 hours after first vaccination. Arm was sore after 2-3 hours of shot. Missed work 1/2 day on Thursday 1/7/2021 because I woke up at 6am with worst headache I?ve had, took Tylenol & it eased off, went into work at my health Dept I work at. Thursday night 1/7, I had headaches so bad I couldn?t sit up, putting ice packs on my head made it worse, ears ringing, started throwing up with severe stomach pains at 11pm on 1/7/2021. Took excederin & Dramamine around 11am Friday 1/8/21, been alternating Tylenol & excederin with some improvement in headache. Slept most all of today 1/8/21 with my highest fever getting up to 100 degrees Fahrenheit on Friday 1/8/21 at 11am. Currently it?s at 98. Bad body aches & feeling uneasy/shaky the night of 1/7/21",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/07/2021,2.0,PUB,"Lexapro, Seasonique birth control, Adderall, Benadryl (for allergies/sinuses), Tylenol (the day of vaccination & every 6-12 hours after vaccination)",,,,Bactrim,"['Abdominal pain upper', 'Feeling abnormal', 'Headache', 'Hypersomnia', 'Impaired work ability', 'Migraine', 'Mobility decreased', 'Pain', 'Pain in extremity', 'Pyrexia', 'Tinnitus', 'Tremor', 'Vomiting']",1,MODERNA,SYR 930902,NJ,52.0,F,"General Malaise, Light Headed, Palpitations & Nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Dizziness', 'Malaise', 'Nausea', 'Palpitations']",1,PFIZER\BIONTECH,IM 930903,NE,32.0,F,"At 7:10am yesterday 1/7/21 I received the covid vaccine. Immediately my lips went numb, and my left arm and hand went numb. I waited at the hospital for 15 minutes and then attempted to drive home. I got about 2 blocks away and noticed my face was numb all the way from my chin to my nose. I went back into work into employee health and let them know. They called the pharmacist who instructed me to go to the ER. While walking to the ER I began to have difficulty breathing, and throat tightness. They called a rapid response alert and I was taken on a stretcher to the ER. I felt dizzy, nauseous and the numbness to my face was from my mid neck up to the top of my hairline at the top of my face. My left hand and arm were still numb. When they took my vitals I was hypertensive BP approximately 155/86, I was also tachycardia HR 104-110. EKG was abnormal-sinus tachycardia HR 104, and probable left atrial enlargement. I began to have severe chills/shaking for approximately 1 hour. I was given 1 liter of normal saline IV, Benadryl 25mg IV, and Zofran 4mg IV. After inspection by the doctor my throat was not swollen, or closing so an epi pen was not administered. My oxygen saturation remained above 91%. After 3 hours of being monitored in the ER my numbness to my face started to improve so I was discharged home. Labs were taken in the ER and my potassium was 3.1, calcium was 8.1. The day prior at my primary care doctors office labs were taken and all my labs were normal including my potassium and calcium. My primary care physician believes the low electrolytes the day of the reaction were due to the reaction to the vaccine. I also had a repeat EKG today (1/8/21) the day after the reaction at my primary cares office and it was normal sinus rhythm with no abnormalities. Vitals were all within normal limits. Today (1/8/21) approximately 36 hours after the vaccine administration I have mild numbness to my face as well as moderate body aches. My primary care physician believes I should not have the second dose of the covid vaccine as she fears I would have a anaphalactic reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Daysee birth control 1 tab per day, omeprazole 20mg per day, trazodone 100mg nightly for sleep, multivitamin one per day, colace stool softener 1 per day, culturelle probiotic 1 per day, fish oil 1 per day",No illnesses,No chronic health conditions,,No allergies,"['Blood calcium decreased', 'Blood potassium decreased', 'Chills', 'Dizziness', 'Dyspnoea', 'Electrocardiogram abnormal', 'Hypertension', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Nausea', 'Pain', 'Sinus tachycardia', 'Throat tightness', 'Tremor']",1,MODERNA,IM 937407,,44.0,M,"Headache, Myalgia, Fever, NauseaVomiting, Hand erythema and swelling Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Erythema', 'Headache', 'Myalgia', 'Nausea', 'Peripheral swelling', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 937413,,43.0,F,"Headache, Myalgia, Fever, chills, generalized itching 7 days later Narrative: Took Benadryl and Zyrtec for the itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Pruritus', 'Pyrexia']",1,PFIZER\BIONTECH,IM 943154,,36.0,M,"Myalgia, Rash, Rash started back of neck/warm to touch. Neck muscle above shoulders pain Narrative: Employee went to Employee Health and was sent home 12/30/2020. No medications taken.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/29/2020,2.0,OTH,,,,,,"['Myalgia', 'Rash', 'Skin warm']",1,MODERNA,IM 943415,,31.0,F,"Headache, NauseaVomiting, Subjective Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Nausea', 'Pyrexia', 'Reaction to previous exposure to any vaccine', 'Vomiting']",UNK,MODERNA,IM 943435,,31.0,M,"Dizziness, NauseaVomiting, Tingling feeling Narrative: Patient returned after 1.5 hours. Monitored an additional 30 minutes. Tingling sensation and nausea diminished. Upon return at 1420: 130/84, HR 79 o2 98%; Recheck 1425: 118-81, HR 73 O2 97%; 1440 120/81, HR 73 O2 98%; 1455 127/85, HR 71 O2 99%. VSS stable. Per patient request, 25mg Diphenhydramine administered by staff Patient sent to ED for further observation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/29/2020,,OTH,,,,,,"['Dizziness', 'Nausea', 'Paraesthesia', 'Vomiting']",1,PFIZER\BIONTECH,IM 943448,,37.0,F,FLUSH THEN CHILLS Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/29/2020,,OTH,,,,,,"['Chills', 'Flushing']",1,PFIZER\BIONTECH,IM 943477,,44.0,F,"Headache, Myalgia, Fever, Temp 101.9 Temp 99.9 1/6 @ 0600",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,SC 943632,,51.0,M,"Agitation, Palpitations, HYPERtension, Tachycardia, Anxiety, clammy skin, nervousness Narrative: Employee with history of severe anxiety, panic attacks. States this is same symptoms as panic attack.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Agitation', 'Anxiety', 'Cold sweat', 'Condition aggravated', 'Hypertension', 'Nervousness', 'Palpitations', 'Tachycardia']",1,MODERNA,IM 943638,,42.0,M,"Headache, Myalgia, NauseaVomiting, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 943799,,39.0,F,"Headache upset stomach, metallic taste, loose stool Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Abdominal discomfort', 'Diarrhoea', 'Dysgeusia', 'Headache']",1,PFIZER\BIONTECH,IM 943891,,40.0,F,Dizziness Tingling Left arm to finger tips.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,OTH,,,,,,"['Dizziness', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 943897,,56.0,F,"Headache, Myalgia & ErythemaMultiform Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Erythema', 'Headache', 'Myalgia']",1,MODERNA,IM 943925,,1.08,F,"Myalgia, Arthralgia, tingling sensation in roof of mouth, thick tongue feeling ""tonsils touching my throat""....occured 6 minutes after injection. Flushed feeling and aches and pains started 90 minutes after injection, and flushed feeling continues through 6 hours. Narrative: tingling sensation in roof of mouth, thick tongue feeling ""tonsils touching my throat""....occured 6 minutes after injection. Flushed feeling and aches and pains started 90 minutes after injection, and flushed feeling continues through 6 hours (has not gone away).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Arthralgia', 'Flushing', 'Myalgia', 'Pain', 'Paraesthesia oral', 'Tongue disorder', 'Tonsillar hypertrophy']",1,MODERNA,IM 943933,,56.0,M,"Headache sore arm, chills Narrative; 12/18 0100 AM woke up with a sore arm. Went back to sleep then woke up in the morning with ongoing sore arm, chills, and headache. He took 400 mg ibuprofen. All symptoms resolved by mid-afternoon on 12/18.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,OTH,,,,,,"['Chills', 'Headache', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 943984,,40.0,F,"Headache, Angioedema, FATIGUE, THROAT TIGHTENING - DENIES DIFFICULTY BREATHING OR SWALLOWING",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Angioedema', 'Fatigue', 'Headache', 'Throat tightness']",1,MODERNA,IM 943994,,35.0,F,"Dizziness Narrative: employee felt light headed after vaccine, no interventions, passed quickly felt better after 20min wait time",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Dizziness', 'Loss of consciousness']",UNK,PFIZER\BIONTECH,IM 944004,,30.0,F,Dizziness Narrative: Pt felt dizzy and did not feel comfortable standing up ~ 10 minutes after vaccination. Pt reported she hadn't eaten in awhile and was given crackers to eat. She was observed for 15 additional minutes and felt better so was released.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Dizziness', 'Dysstasia']",1,MODERNA, 944108,,42.0,F,"Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination - bleeding at the injection site which the employee reports as filling the bandaid over the site. When she got home in the evening and took it off blood ran down her arm but the bleeding stopped immediately. This has resolved. 12/29 at about 2:00 employee reports onset of tingling in the fingers of her right hand - index, middle, ring, and pinky. For about 2 hours the tingling was intense. As of 12/30 this has markedly improved and the tingling is intermittent. Later in the evening of 12/29 she noticed the onset of muscle pains throughout her body but especially in her feet. She also became very fatigued. These symptoms linger on 12/30. On 1/1 employee reports symptoms muscle soreness had resolved. 1/4 tingling in her fingers/arm has improved but is still present. She will follow-up with her PCP if this symptom persists beyond 2-4 weeks.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Fatigue', 'Haemorrhage', 'Immediate post-injection reaction', 'Injection site haemorrhage', 'Myalgia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 944395,,55.0,M,Myalgia Dry mouth; pain and swelling of left arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Dry mouth', 'Myalgia', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 944398,,39.0,F,"Tachycardia (see above, tachycardia) Narrative: Recipient immediately felt ""bad"" s/p vaccination - vitals demonstrated HR 133. No other signs or symptoms of anaphylaxis. Tachycardia resolved within 1-2 minutes of rest without intervention to HR of high 70s-low 80s. BP 131/91, SpO2 98% on room air, temperature 98.4F. Recipient able to ambulate on own to exam room. Exam benign, including recipient's HR observed prior to/during/after exam to be high 70s. Tolerated oral intake without issue, no further intervention indicated. Recipient observed for 30 minutes after vaccine administration without further issue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Feeling abnormal', 'Immediate post-injection reaction', 'Tachycardia']",1,MODERNA,IM 944401,,41.0,F,"Myalgia, Arthralgia fatigue, polyuria and soreness in shoulder 12/27. weakness 12/28. pain upper UE is better, mild soreness conts in LE 12/29",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,"['Arthralgia', 'Asthenia', 'Fatigue', 'Myalgia', 'Pain in extremity', 'Polyuria']",1,MODERNA,IM 944404,,35.0,F,"tingling lips, thick tongue approx 7 minutes after administration of vaccine, lasted 1 minute Employee had tingling of her lips and felt like a thick tongue. She states it lasted 1 minute.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/29/2020,,OTH,,,,,,"['Paraesthesia oral', 'Tongue disorder']",1,MODERNA,IM 944406,,1.08,M,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia']",UNK,MODERNA, 944408,,1.08,M,Headache & Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 944410,,1.08,M,Headache & Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia']",UNK,MODERNA, 944411,,48.0,F,"Myalgia NUMBNESS, NUEropathy, tingling, pain bilateral calves Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Hypoaesthesia', 'Myalgia', 'Neuropathy peripheral', 'Pain in extremity', 'Paraesthesia']",1,MODERNA,IM 944413,,58.0,M,Myalgia & Arthralgia,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Arthralgia', 'Myalgia']",1,PFIZER\BIONTECH,IM 944417,,56.0,F,"Rash red, swollen, tender, warm at left arm injection site; fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Fatigue', 'Injection site pain', 'Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Rash erythematous']",1,MODERNA,IM 944421,,54.0,M,"Subtle tingling left earlobe and left jaw Narrative: Patient complains of occasional tingling ""pins and needles"" sensation in left ear, left jaw starting 2 days after vaccination . No other complaints. Has not followed up with physician. States sometimes ""it feels like its getting better""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/24/2020,2.0,OTH,,,,,,['Paraesthesia'],1,PFIZER\BIONTECH,IM 944424,,53.0,M,"Fever, NauseaVomiting, Tachycardia, COVID Vaccine administered 12/28 and nausea began pm with fever the following day with chills,fatigue,andtachycardia. Tmax102F",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Nausea', 'Pyrexia', 'Tachycardia', 'Vomiting']",1,MODERNA,IM 944427,,1.08,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Headache'],UNK,MODERNA,IM 944430,,47.0,M,"Dizziness, Headache, NauseaVomiting, achey, lightheaded",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,,"yes-spiked a temp w/ anthrax vacc 1999, 2004- broke out in cox pox after receiving small pox vacc",,"['Dizziness', 'Headache', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,SC 944434,,53.0,F,"Myalgia, Arthralgia, chills, goosebumps, temp 98.6, took tylenol 1000mg Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Myalgia', 'Piloerection']",1,MODERNA,SC 947873,,49.0,F,TIAStroke numbness of R face and RUE Narrative: I recommended transfer via 911 from clinic to nearest ER; she refused and signed out against medical advice. She plans to go to ER by private vehicle driven by a friend.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/29/2020,,OTH,,,,,,"['Hypoaesthesia', 'Transient ischaemic attack']",1,MODERNA,IM 947899,,68.0,F,HYPERtension & Tachycardia Narrative: Increased heart rate and blood pressure following vaccination. Required ER visit.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Blood pressure increased', 'Heart rate increased', 'Hypertension', 'Tachycardia']",UNK,MODERNA,IM 947907,,27.0,F,"lump in throat Narrative: lump in throat lasted about one hour, ED told her it was not an allergic reaction,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/22/2020,,OTH,,,,,,['Sensation of foreign body'],1,MODERNA,IM 950259,,58.0,F,"Appendectomy Narrative: Developed abdominal pain with nausea on 12/24/2020, went to ER and noted to have appendicitis, resulting in an appendectomy",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Abdominal pain', 'Appendicectomy', 'Appendicitis', 'Nausea']",1,MODERNA,IM 950260,,44.0,F,NauseaVomiting flushing,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,history of anaphylaxis,,"['Flushing', 'Nausea', 'Vomiting']",1,MODERNA,IM 950261,,62.0,F,"Confusion, Fever, SkinRash, Rash, Diarrhea, NauseaVomiting, HYPERtension, SWOLLEN TONGUE W/RASH; HIGH SED RATE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,"['Confusional state', 'Diarrhoea', 'Hypertension', 'Nausea', 'Pyrexia', 'Rash', 'Red blood cell sedimentation rate increased', 'Swollen tongue', 'Tongue eruption', 'Vomiting']",1,MODERNA,IM 950262,,,F,"Dizziness & Tachycardia 45yo female, rapid response call, here for palpitations, n/v, dizziness, ""feeling faint"" s/p getting covid vaccine at 8am. PT stated her reaction started 5/10 mins after vaccine and went away in 12 minutes. Denies hx of cardiac issues or in her family. No hx of tobacco use.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/28/2020,,OTH,,,,,,"['Dizziness', 'Palpitations', 'Tachycardia']",1,MODERNA,IM 950263,,51.0,M,"BlurredVision, Confusion, Dizziness, Headache, NauseaVomting, Mild/ Migraine and dizziness/ No known previous reactions Narrative: 10 minutes after injection she felt a migraine, with hx migraines. Vitals were stable. 20 minutes post injection she said she felt dizzy, woozy and slightly confused.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/28/2020,,OTH,,,,,,"['Confusional state', 'Dizziness', 'Headache', 'Migraine', 'Nausea', 'Vision blurred', 'Vomiting']",1,MODERNA,IM 950264,,,M,"BlurredVision, Headache, lightheadedness, visual disturbance, diaphoresis Narrative: has orthostatic hypotension - referred to emergency room",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/28/2020,,OTH,,,,,,"['Dizziness', 'Headache', 'Hyperhidrosis', 'Orthostatic hypotension', 'Vision blurred', 'Visual impairment']",1,MODERNA,IM 950265,,55.0,F,"Dizziness, NauseaVomiting, HYPERtension, lightheadedness, abdominal cramping Narrative: Employee reported nausea and lightheadedness approximately 5 mins of vaccine administration. BP was 155/86. Within a few mins she developed a headache and dizziness. BP check at this time 165/93. Employee escorted to ED for eval. She was given 1 liter Lactated Ringers and 4mg IV zofran, which resulted in symptom resolution. She was discharged home from the ED around 1:40 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Abdominal pain', 'Dizziness', 'Headache', 'Hypertension', 'Nausea', 'Vomiting']",1,MODERNA,IM 950266,,54.0,F,"Tachypnea, Tachycardia, Tingling in Arms, Flushing 911 was called and patient was transported to hospital emergency room",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/28/2020,,OTH,,,,,,"['Flushing', 'Paraesthesia', 'Tachycardia', 'Tachypnoea']",1,MODERNA,IM 950267,,45.0,F,"Metallic taste in her mouth, swollen lips and cheeks, slight difficulty breathing, thought to be d/t anxiety Narrative: Employee reported anaphylactic reaction to previous vaccination but apparently denied this in ED. Has allergy to penicillin, receives weekly iron infusions. Given Benadryl and sent home in stable condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/23/2020,,OTH,,,,"Per vaccination form, no information available",,"['Anxiety', 'Dysgeusia', 'Dyspnoea', 'Lip swelling', 'Swelling face']",1,MODERNA,IM 950268,,38.0,F,"RespDepression SOB, eye swollen, face red, pepcid, claritin",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Dyspnoea', 'Erythema', 'Eye swelling', 'Respiratory depression']",1,MODERNA,IM 950269,,53.0,F,Headache & NauseaVomiting Narrative: Employee reported headache approximately 15 mins after initial vaccine admin. BP at 15 min check 145/86. BP recheck ten minutes later 145/81. She also reported moderate nausea at this time. Employee escorted to ED for further eval. BP WNL on arrival to ED and no further intervention performed. She was discharged home.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/28/2020,,OTH,,,,,,"['Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 951292,,,M,"Dizziness, HYPOtension & Bradycardia Patient received the moderna vaccine at around 0750 on 1/5/2021. 0755 he reported feeling dizzy. Provider present, patient reclined. Pt PB approximately 70/35, bradycardic. 2L O2, Epi given. Brought to ER, BP increased to approximately 120/90 patient awake and talking.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,"yes patient reported having tingling in throat to flu vaccine in 2020, but did not have swelling or SOB.",,"['Bradycardia', 'Dizziness', 'Hypotension']",1,MODERNA,IM 951293,,36.0,M,"HYPERtension Elevated Temperature of 99.4F Narrative: Pt. referred to ED for eval of possible covid vaccine reaction ""a fever"" per pt.;denies CP/SOB/vomiting. Vaccine administered to R deltoid.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Hypertension', 'Pyrexia']",1,MODERNA,IM 951294,,42.0,F,"Dizziness, Headache, SkinRash, Rash & HYPERtension",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Dizziness', 'Headache', 'Hypertension', 'Rash']",1,MODERNA,IM 951295,,64.0,M,Myalgia & Diarrhea Narrative: Went to ER on 12/24/2020 for Body Aches and diarrhea.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/24/2020,2.0,OTH,,,,unknown,,"['Diarrhoea', 'Myalgia', 'Pain']",1,PFIZER\BIONTECH,IM 951296,,34.0,F,"Myalgia, Fever, Diarrhea, NauseaVomiting, fatigue, legs swelling;",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/28/2020,5.0,OTH,,,,,,"['Diarrhoea', 'Fatigue', 'Myalgia', 'Nausea', 'Peripheral swelling', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 951297,,61.0,F,"Dizziness Narrative: Employee was given the Moderna Covid vaccine at approximately 1106 am. Patient was placed on a 30 minute monitor due to her hx of having a severe allergic reaction to Penicillin. At the end of the 30 minutes (at approximately 1136), patient reported having dizziness. When questioned if this was a new symptom for her she reported that she has had vertigo in the past when she had a sinus infection but has not experienced vertigo recently. Patient's VS were immediately taken. Results 98.2-60-20-150/83 (Sitting-LA 156/87 (Sitting-RA) SAO2 98%-RA Pain=0. Patient denied chest pain, SOB, or itching/rash/hives, and was in no apparent distress. This nurse informed patient that 911 would have to be notified in order for her to be further assessed, and she agreed. 1142-911 was notified. Patient remained seated with no changes in condition. Leadership notified, and was on site at 1154, when EMT's arrived. Patient was transported off site at 1156.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Dizziness', 'Vertigo']",1,MODERNA,IM 951299,,53.0,F,"UrticariaPruritus Eventual 10cm round erythematous, painful, puritic induration was diag with cellulitis",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/25/2020,12/25/2020,0.0,OTH,,,,,,"['Cellulitis', 'Erythema', 'Induration', 'Pain', 'Pruritus', 'Urticaria']",1,MODERNA,IM 951300,,27.0,F,"Headache, Myalgia, Diarrhea, NauseaVomiting, Fatigue Narrative: 1/1/21; ED visit for dehydration. Covid negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/01/2021,3.0,OTH,,,,,,"['Diarrhoea', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 951301,,54.0,M,"RespDepression, Rash, paresthesia extremtiies (>24 hours post vaccine) Narrative: employee developed rash/hives 24 hours after vaccine; which progressed over time (initially arms, waist, then torso, face). She also began having shortness of breath. She took otc bendaryl day after vaccine but due to worsening of symptoms, she went to a community ER where she was treated with several doses of IV bendary, steroids, Pepcid, and zyrtec. Her symptoms have improved but she is still taking benadryl and steroid taper.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Dyspnoea', 'Paraesthesia', 'Rash', 'Respiratory depression', 'Urticaria']",1,PFIZER\BIONTECH,IM 951302,,30.0,F,"Tachycardia Narrative: Pt. received the Moderna COVID-19 vaccination at 1030. At 1040 pt. altered staff and stated that she felt like her heart was beating too fast. and that the back of her tongue felt tingly. Vitals were taken and found HR 130 bpm and SpO2 100% on RA, temp 99.1, BP 117/90. On site provider was notified and prescribed Benadry 50mg PO. Pt. was monitored for an additional 30 minutes. VS at 1100 were BP 116/85, HR 112, SpO2 99%. Sent to ED for observation until symptoms resolve.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/06/2021,,OTH,,,,,,"['Body temperature increased', 'Paraesthesia oral', 'Tachycardia']",1,MODERNA,IM 951303,,59.0,F,"NauseaVomiting, HYPERtension & Tachycardia Approx 15 mins after injection employee reported nausea was found to be tachycardia and hypertensive.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Hypertension', 'Nausea', 'Tachycardia', 'Vomiting']",1,MODERNA,IM 951304,,64.0,M,Dizziness & HYPOtension Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,"['Dizziness', 'Hypotension']",1,PFIZER\BIONTECH,IM 951305,,35.0,F,"Locked up for about 1-2 minutes then became diaphoretic Narrative: Employee was taken to the emergency department for further assessment. Came to after going into a state of ""locked up"" for about 1-2 minutes, then became diaphoretic. After 1-2 minutes, employee was able to speak, was alert and oriented and was transported for further evaluation to our ED. She was able to provide us with her personal information to submit this report.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Hyperhidrosis', 'Locked-in syndrome']",1,PFIZER\BIONTECH,IM 951306,,43.0,F,"Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling ""heaviness"" in legs ""can't move"" and ""left eye feels funny, like twitching and my blood pressure feels high"" Narrative: Pt reports high anxiety along with stated symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Abnormal sensation in eye', 'Anxiety', 'Dizziness', 'Limb discomfort', 'Mobility decreased', 'Muscle twitching', 'Nausea', 'Tachycardia', 'Vomiting']",1,PFIZER\BIONTECH,IM 951307,,33.0,F,"NauseaVomiting, Tachycardia, Shortness of breath, chest tightness Narrative: Onset of tachycardia within 15 minutes. Within one hour this worsened, and developed associated chest tightness and nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,unknown,,"['Chest discomfort', 'Dyspnoea', 'Nausea', 'Tachycardia', 'Vomiting']",1,MODERNA,IM 951308,,35.0,F,"Dizziness, NauseaVomiting, While being monitored, pt ran to the bathroom and then was observed holding onto wall/divider, ""felt like might fall down"" ""tingling in left arm and leg"", sweating. BP 100/80 PR 80, 115/87 PR 77, reports has drank 30-40 oz of water in the morning prior Narrative: Rapid Response called",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Balance disorder', 'Dizziness', 'Hyperhidrosis', 'Nausea', 'Paraesthesia', 'Vomiting']",1,PFIZER\BIONTECH,IM 951309,,41.0,F,"NauseaVomiting,HYPERtension & HYPERglycemia Narrative: Employee received vaccine. Seven minutes later, she began experiencing nausea and vomiting. She vomited, and a STAT team was called and we transported her to ER for evaluation. In ER, she had BP of 157/106, and blood glucose of 288. Other vitals were O2 saturation of 100%. She is diabetic and states her fingerstick glucose right before lunch at 12N was 120. After about 30 minutes observation in ER she was released, nausea subsided and she did not require antiemetic medication.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Blood glucose increased', 'Blood pressure increased', 'Hyperglycaemia', 'Hypertension', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 951310,,48.0,F,"Angina & Tachycardia Narrative: Employee transferred to the ER for further treatment. Employee given DIPHENHYDRAMINE INJ,SOLN 25MG/0.5ML IV Now dose and METHYLPREDNISOLONE INJ,SOLN 125MG/1VIAL IVP ONCE. 12 leads EKG showed Sinus Tachycardia. No other respiratory distress reported. The employee was closely monitor in ER for couple of hours. Employee reported feeling better after pharmacological interventions. Employee's health status improved. ED Provider sent patient home in stable condition with 5-6 Steroids PO treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/22/2020,,OTH,,,,Coma/12/2003/ Tetanus Toxoid,,"['Angina pectoris', 'Electrocardiogram', 'Sinus tachycardia']",1,PFIZER\BIONTECH,IM 951311,,43.0,F,RespDepression & HYPERtension Narrative: Employee reported difficulty breathing within 15 minutes of vaccine administration. She was given oral Benadryl and one dose of epinephrine per epi pen. She was taken to the ER for further evaluation.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Dyspnoea', 'Hypertension', 'Respiratory depression']",UNK,PFIZER\BIONTECH, 951312,,43.0,F,"Angioedema, HYPERtension & Tachycardia Acute mild allergic reaction //Patient placed in a cardiac monitor //Given Solu-Medrol as well as Pepcid //No evidence of anaphylaxis, epinephrine is not indicated at this time //No worsening of sx. vs improved. //will DC home with steroids.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Angioedema', 'Hypersensitivity', 'Hypertension', 'Tachycardia']",1,PFIZER\BIONTECH,IM 951313,,53.0,M,"Dizziness, HYPERtension, Light Headed Narrative: Subjective/Chief Complaint: 'lightheaded' Pt reports sudden onset of lightheaded approx. 10 mins after received Covid vaccine injection with SBP of 180 at the time. Currently c/o lightheadedness, denies n/v/cp/sob, pt reports no sickness symptoms before injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Dizziness', 'Hypertension']",1,MODERNA,IM 951314,,60.0,F,"RespDepression, CoughWheeze & Syncope Narrative: Patient started having shortness of breath about 20 minutes after injection. First reported as a cough then asked for water and was having difficulty breathing.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Cough', 'Dyspnoea', 'Respiratory depression', 'Syncope', 'Wheezing']",UNK,MODERNA,IM 951315,,35.0,M,"Dizziness, CoughWheeze, NauseaVomiting, HYPERtension, generalized itching, absent of rash or generalization monitored in emergency department, discharged without concern",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Cough', 'Dizziness', 'Hypertension', 'Nausea', 'Pruritus', 'Vomiting', 'Wheezing']",1,MODERNA,IM 951316,,42.0,F,"Diarrhea, NauseaVomiting, HYPERtension, Tachycardia, tingling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Hypertension', 'Nausea', 'Paraesthesia', 'Tachycardia', 'Vomiting']",1,MODERNA,IM 951324,,35.0,M,"@1052 pt c/o numbness and tingling in left arm and it intensified to left leg, right toes, left side of face. @1100 c/o of same numbness in addition to heaviness from the shoulders down and a little dizzy. @1115 pt stated he felt better and stated he felt Narrative: @1052 BP 123/85,Pulse 73, Res 16, SP02 99 RA: pt c/o numbness and tingling in left arm and it intensified to left leg, right toes, left side of face @ 1100 BP 117/78, Pulse 73, Rep 16, SP02 99 RA: c/o of same numbness in addition to heaviness from the shoulders down and a little dizzy. @ 1115 BP 132/77, Pulse 68, Rep 16, SP02 98 RA. pt stated he felt better and stated he felt numbness in left arm and left leg. Offered Benadryl pt declined and stated ""he was fine to leave."" Pt returned to clinic @1243 BP 137/89, Pulse 71, Rep 16, SP02 98 RA: c/o same tingling but migrated to neck but reported no shortness of breath. 1250: BP 137/89, Pulse 74, Rep 16, SP02 RA: eBenadryl given and code 99 called. Pt transported ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Dizziness', 'Hypoaesthesia', 'Limb discomfort', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 955550,,56.0,M,Headache Fatigue Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache']",1,MODERNA,IM 955582,,57.0,F,"Myalgia, Fever, arm pain Narrative: Reported that the morning of 12/24/2020 right arm was swollen and sore. By that evening she developed shaking chills, muscle aches, and fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 955585,,33.0,F,pain @ injection site. Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Injection site pain'],1,MODERNA,IM 955592,,36.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 955599,,53.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 955776,,55.0,M,"Headache, Myalgia, Fever, Tired, Temperature 100.1 with pulse 110",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",UNK,MODERNA,IM 955778,,48.0,F,"Headache, Myalgia, NauseaVomiting, chills Narrative: Reports chills, headache, nausea, vomiting, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 955779,,34.0,F,"Myalgia pain at site of injection, joint pain in entire arm on injection site (R). Malaise. Narrative: difficulty getting dressed due to pain in right arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Injection site joint pain', 'Injection site pain', 'Loss of personal independence in daily activities', 'Malaise', 'Myalgia', 'Pain in extremity']",1,MODERNA,IM 955781,,43.0,M,Headache Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Headache'],UNK,MODERNA, 957810,,31.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 957882,,58.0,F,"Headache, Myalgia & Fever Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/29/2020,,OTH,,,,,,"['Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 957883,,28.0,F,NauseaVomiting Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Nausea', 'Vomiting']",1,MODERNA, 957884,,47.0,F,"Headache, Myalgia, Fever & NauseaVomiting Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 957885,,59.0,M,Myalgia fatigue Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Fatigue', 'Myalgia']",UNK,MODERNA, 957886,,26.0,F,"Myalgia, Fever & NauseaVomiting Narrative: Employee states that symptoms did not start until the middle of the night after injection. States she woke up with ""severe"" arm pain, headache, dry mouth, nausea, body aches and fever. Highest noted to be 101.4",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/28/2020,,OTH,,,,,,"['Dry mouth', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 957958,,33.0,F,"Tachypnea, HYPERtension & Tachycardia Employee endorsed initial ""lightheadedness and flushing"" and mild difficulty breathing. Patient was hypertensive With BP Sys in 160s-170s and Dys 90s, Patient denies history of hypertension Patient was also experiencing tachycardia with HR ranging from the 90s- 110s. Patient reports ""Heart beating really fast"", and ""heart beating out of chest"" Patient was transferred to ER at 1330 for further evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/29/2020,,OTH,,,,,,"['Dizziness', 'Dyspnoea', 'Flushing', 'Heart rate increased', 'Hypertension', 'Tachycardia', 'Tachypnoea']",1,MODERNA,IM 957966,,40.0,F,"Headache Fever, 102.8. severe heartburn. Fever, 102.8. headache. Sever heartburn.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Dyspepsia', 'Headache', 'Pyrexia']",1,MODERNA,IM 957975,,42.0,M,Rash Narrative: Reported head to toe rash that started 12/28/2020 in the evening Will be seeing primary care provider,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Rash'],1,MODERNA,IM 957981,,54.0,F,Myalgia chills Reported horrible body aches and chills that started the evening of the injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pain']",1,MODERNA,IM 957989,,58.0,F,"Headache, ErythemaMultiform, 12/28/20 & 12/29/20 Pt notice a rash appear in shower the morning after vaccination was administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Erythema multiforme', 'Headache', 'Rash']",1,MODERNA,IM 957996,,57.0,M,Chest tightness and chest warmth,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,OTH,,,,,,['Chest discomfort'],1,MODERNA, 958003,,45.0,M,"SkinRash, Rash, NauseaVomiting, Palpitations, Feeling ""hot"" and ""clammy"" Narrative: Employee received vaccine around 10:30am. At around 10:45 employee reported palpitations, nausea, headache, and feeling ""hot"" and ""clammy"". BP 193/119 with a HR of 95. After 15 mins of rest, employee continued to feel poorly reporting a slight worsening of symptoms. Face appeared very flushed. BP on recheck 193/112 with a HR of 105. Employee escorted to ED for evaluation at this time. In ED, employee developed full body rash. Was given 50mg IVP benadryl and 125mg IVP methylprenisolone in addition to 1L of Lactated Ringers- all with symptom improvement. Allergy/Immunology consulted. Recommend serum tryptase level. If elevated, advised that employee should not receive second vaccine dose. Employee discharged home with RX for epi-pen, prednisone, and cetirizine. Of note, employee reports a history of Thalassemia. Has a hx of hives with PCN and a rash with cipro.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Cold sweat', 'Feeling abnormal', 'Feeling hot', 'Flushing', 'Headache', 'Nausea', 'Palpitations', 'Rash', 'Vomiting']",1,MODERNA,IM 958004,,37.0,M,Headache tingling to hands and feets Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Headache', 'Paraesthesia']",1,MODERNA,IM 958079,,33.0,F,"Headache, Myalgia, NauseaVomiting, shaking chills Narrative: Reports that one hour following the vaccine she developed a migraine and had nausea/vomiting, severe arm pain, and shaking chills",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Pain in extremity', 'Vomiting']",1,MODERNA,IM 958080,,57.0,M,Rash itchy rash along spine at level of high back.neck Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/27/2020,4.0,OTH,,,,,,"['Rash', 'Rash pruritic']",UNK,MODERNA, 958081,,53.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958087,,59.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958088,,44.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958095,,62.0,F,"Headache, Myalgia, Subjective fever, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 958096,,41.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958097,,57.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,['Myalgia'],UNK,MODERNA,UN 958098,,1.08,M,fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,['Pyrexia'],UNK,MODERNA,IM 958099,,46.0,F,"Headache Also reported ""fatigue and my throat glands seem swollen"" Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Lymphadenopathy']",1,MODERNA,IM 958100,,60.0,F,"Headache, Myalgia, NauseaVomiting, Mental fogginess Narrative: Pt reported headache x 3 days. She has fully recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Feeling abnormal', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 958101,,49.0,F,Headache & NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/26/2020,3.0,OTH,,,,,,"['Headache', 'Nausea', 'Vomiting']",UNK,MODERNA, 958103,,32.0,M,"Palpitations PT STATED ""HEART RACING"" AMB TO RM WITH STRETCHER.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Palpitations'],1,PFIZER\BIONTECH,IM 958108,,45.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958115,,74.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958130,,62.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958138,,56.0,F,"Headache, Myalgia, UrticariaPruritus, Knott on the arm at the site, urticarial rash only at the site of the injection Narrative: Employee taking Ibuprofen every 8 hours for the myalgias",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Headache', 'Injection site nodule', 'Injection site reaction', 'Myalgia', 'Pruritus', 'Urticaria']",1,MODERNA,IM 958139,,27.0,M,"Myalgia, Arthralgia & NauseaVomiting Narrative: Nausea and vomiting starting night of vaccine. Developed body aches, joint pain, and continued nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Arthralgia', 'Myalgia', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,IM 958146,,56.0,F,Headache Reported Sore arm and severe headache. Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Pain in extremity']",1,MODERNA,IM 958269,,60.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958279,,41.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958288,,28.0,F,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,['Myalgia'],1,MODERNA, 958298,,36.0,F,"Rash Narrative: Patient alerted the Covid Team/nurse she noticed a rash centrally located on her belly and her back. She states there is some mild redness and slight itching, denies any hives. She denies any pain or warmth to these sites. Suggested to patient she take benadryl to help resolve these symptoms. Patient voiced an understanding and advised patient to call with any questions or concerns. patient voiced an understanding.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Erythema', 'Pruritus', 'Rash']",1,MODERNA,IM 958302,,40.0,F,Dizziness & RespDepression Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/29/2020,,OTH,,,,,,"['Dizziness', 'Respiratory depression']",1,MODERNA,IM 958305,,49.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958306,,47.0,M,UrticariaPruritus,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Pruritus', 'Urticaria']",UNK,MODERNA, 958308,,28.0,F,Redness and mild pain at injection site. Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Injection site erythema', 'Injection site pain']",1,MODERNA,IM 958309,,59.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958310,,40.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958311,,33.0,M,Dizziness Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/29/2020,,OTH,,,,,,['Dizziness'],UNK,PFIZER\BIONTECH, 958320,,62.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958374,,48.0,F,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/28/2020,,OTH,,,,,,"['Headache', 'Myalgia']",1,PFIZER\BIONTECH,IM 958382,,59.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958387,,60.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958391,,47.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958395,,68.0,F,Myalgia & Arthralgia Symptoms started on 12/25/2020 and continued through 12/28/2020. Recommended to see rheumatologist.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,OTH,,,,"Yes, Shingles 07/2020, however resolved within 24 hours.",,"['Arthralgia', 'Myalgia']",1,MODERNA,IM 958397,,51.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958403,,64.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958413,,60.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958418,,32.0,F,"Myalgia, NauseaVomiting, Fatigue Narrative: Off work x 2 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Fatigue', 'Impaired work ability', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 958420,,46.0,F,Headache & Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 958427,,59.0,M,"Myalgia, Arthralgia, chills Narrative: body aches and chills persisted for 24hrs after vaccine. Some relief with 1000mg of acetaminophen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Myalgia', 'Pain']",1,MODERNA,IM 958435,,52.0,M,"Headache, Myalgia, NauseaVomiting, Fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 958441,,46.0,M,face and eyes numb x 2 hrs Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Hypoaesthesia', 'Hypoaesthesia eye']",1,MODERNA,IM 958443,,1.08,F,"death by suicide Narrative: death by suicide; 12/26/20, self inflicted gun shot wound; found deceased by family member",Yes,12/26/2020,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/26/2020,2.0,OTH,,,,,,"['Completed suicide', 'Death', 'Gun shot wound']",UNK,PFIZER\BIONTECH, 958450,,26.0,M,Fever fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Fatigue', 'Pyrexia']",1,MODERNA,IM 958457,,54.0,F,"Headache, Myalgia & Diarrhea Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/29/2020,,OTH,,,,,,"['Diarrhoea', 'Headache', 'Myalgia']",1,MODERNA,IM 958466,,58.0,F,Myalgia Narrative: Developed significant pain left trapezius and left side of neck following injection. Pain started to subside before she left clinic. On follow-up conversation pain completely resolved in 1-2 hours. No treatment required,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Back pain', 'Myalgia', 'Neck pain']",1,MODERNA,IM 958469,,62.0,M,Myalgia & Fever Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Myalgia', 'Pyrexia']",1,MODERNA,IM 958481,,58.0,M,Headache & NauseaVomiting Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 958484,,55.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 958488,,22.0,F,"BlurredVision, Dizziness & HYPOtension Narrative: Patient experienced blurred vision, dizziness, and hypotension within minutes of receiving the vaccine at the same time the employee across from her getting the vaccine was having a similar reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Dizziness', 'Hypotension', 'Vision blurred']",1,MODERNA,IM 958491,,38.0,M,Fever chills Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Chills', 'Pyrexia']",1,MODERNA,IM 958498,,55.0,F,extreme fatigue Narrative: Reported extreme fatigue following injection,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,OTH,,,,,,['Fatigue'],1,MODERNA,IM 960780,,62.0,F,"Headache, Myalgia, Chills, Rigors, Bloating",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Abdominal distension', 'Chills', 'Headache', 'Myalgia']",1,MODERNA, 960781,,29.0,F,"Headache, NauseaVomiting, Chills, sweats Narrative: Off work one day",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Chills', 'Headache', 'Hyperhidrosis', 'Impaired work ability', 'Nausea', 'Vomiting']",1,MODERNA,IM 961416,,35.0,M,"Headache, Myalgia, NauseaVomiting, left arm myalgia after vaccine on 12/23/2020; on 12/25/2020 lost taste with waxing waning headache and nausea through 12/26/2020; no symptoms on 12/27/2020; today 12/28/2020 has waxing waning headache and nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,OTH,,,,unknown,,"['Ageusia', 'Headache', 'Moaning', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 961424,,58.0,F,Rash & UrticariaPruritus,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,OTH,,,,,,"['Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 961430,,52.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Headache'],1,MODERNA,IM 961694,,58.0,F,"Arthralgia Arthralgia, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Arthralgia', 'Pain']",1,MODERNA,IM 961702,,32.0,F,tingling in the R arm and leg; swelling in the R side of the face/cheek Narrative: Employee reports after having vaccine felt tingling in her R arm; later R leg and facial/ cheek swelling on the Right side. Remained the same overnight and was seen the next day 12/29/2020. Benadryl order and employee sent home,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Paraesthesia', 'Swelling face']",1,MODERNA,IM 961707,,54.0,F,"Myalgia, Arthralgia, 12/25 2000 noticed sore arm 17:00 followed by myalgias arthralgia, extremities, and lower back, lower LE, fully resolved 12/29.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,"['Arthralgia', 'Back pain', 'Myalgia', 'Pain in extremity']",1,MODERNA,IM 961712,,52.0,M,"Myalgia, Fever, Sore throat, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Fatigue', 'Myalgia', 'Oropharyngeal pain', 'Pyrexia']",1,MODERNA,IM 961719,,34.0,F,"Headache, Myalgia, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia']",1,PFIZER\BIONTECH,IM 961724,,56.0,M,"Myalgia Loss of smell, generalized weakness Narrative: Received COVID-19 VACCINE on 12/23/2020. 24 hours after receiving the vaccine I had body aches, loss of smell and general weakness. All symptoms are gone except I still have loss of smell and easily get tired. Other than that I am feeling ok (12/282020).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Anosmia', 'Asthenia', 'Fatigue', 'Myalgia', 'Pain']",1,MODERNA,IM 961729,,51.0,F,Myalgia & Diarrhea Narrative: Employee called OHC to report side effects that occurred the night of vaccination and now getting better.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Diarrhoea', 'Myalgia']",1,PFIZER\BIONTECH,IM 961734,,31.0,F,"Tachycardia Narrative: Employee reported elevated Heart Rate for the last hour running in the 110's to 120's. Current heart rate is 124, with no other symptoms reported. Will continue to follow up with employee daily to check on status. Employee was reported to contact 911 or go to the nearest Emergency Room if symptoms worsen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Heart rate increased', 'Tachycardia']",1,MODERNA,IM 961740,,51.0,F,"BlurredVision, NauseaVomiting, Symptoms started eve of 12/28/2020 as above with marked generalized fatigue and pain on left deltoid. Feels better 12/29 with only left deltoid pain remaining.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Fatigue', 'Injection site pain', 'Nausea', 'Vision blurred', 'Vomiting']",1,MODERNA,IM 961746,,43.0,F,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Myalgia'],UNK,PFIZER\BIONTECH, 961754,,39.0,F,Dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Dizziness'],1,MODERNA,IM 961764,,39.0,M,"TINGLING BLE Narrative: Employee reported numbness/tingling to BLE almost immediately upon receipt of vaccine. Within one hour, he reported back to provider, that symptoms had not subsided. I tried to call him today to follow up but was unsuccessful in contacting him.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Hypoaesthesia', 'Immediate post-injection reaction', 'Paraesthesia']",1,MODERNA,IM 961778,,29.0,F,"Headache, Myalgia, NauseaVomiting, sore throat, congestion, neck sore to touch, neck stiffness Narrative: Recommend symptomatic treatment with Tylenol, ibuprofen, rest.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Headache', 'Musculoskeletal stiffness', 'Myalgia', 'Nausea', 'Neck pain', 'Oropharyngeal pain', 'Respiratory tract congestion', 'Vomiting']",1,MODERNA,IM 961786,,25.0,F,"Headache, Myalgia, Fever, Rash, NauseaVomiting, Chills Narrative: Unable to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/25/2020,12/26/2020,1.0,OTH,,,,,,"['Chills', 'Headache', 'Impaired work ability', 'Myalgia', 'Nausea', 'Pyrexia', 'Rash', 'Vomiting']",1,MODERNA,IM 961802,,45.0,M,"Myalgia & Fever Narrative: Employee has reported a low-grade fever, muscle and body aches, chills, flu-like symptoms. Informed employee if symptoms get worse call 911 or go to the nearest Emergency Room. Will continue to monitor employee daily.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Chills', 'Influenza like illness', 'Myalgia', 'Pain', 'Pyrexia']",1,MODERNA,IM 961819,,53.0,M,Diarrhea Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/29/2020,,OTH,,,,,,['Diarrhoea'],1,MODERNA,IM 961850,,37.0,M,"Headache, Myalgia, Fever, Body aches, low grade fever 99.5, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/28/2020,1.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pain', 'Pyrexia']",1,MODERNA,IM 961852,,54.0,F,Headache & Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Headache', 'Pyrexia']",1,MODERNA,IM 961853,,59.0,F,"Dizziness & NauseaVomiting Narrative: Employee reported dizziness that persisted for 45 minutes, incident occurred 17 hours following injection. Employee further reports that she did not eat breakfast and situation that precipitated event was bending over and standing upright quickly while assisting a patient. Employee has since fully recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Dizziness', 'Dizziness postural', 'Nausea', 'Vomiting']",1,MODERNA,IM 961854,,39.0,F,"Headache, Myalgia, Body aches, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pain']",1,MODERNA,IM 961855,,27.0,F,"Headache sweaty, chills Reports headache, sweaty, chills. Affecting work day.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Chills', 'Headache', 'Hyperhidrosis', 'Impaired work ability']",1,MODERNA,IM 961856,,43.0,M,"Headache, Myalgia, Diarrhea, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Diarrhoea', 'Fatigue', 'Headache', 'Myalgia']",1,MODERNA,IM 961857,,45.0,F,"Myalgia Chills, Rigors",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Chills', 'Myalgia']",1,MODERNA, 961858,,27.0,M,"Dizziness, Headache, chills, pain at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Chills', 'Dizziness', 'Headache', 'Injection site pain']",1,MODERNA,IM 961859,,45.0,F,"Headache, Myalgia, Arthralgia, NauseaVomiting, Received Vaccine 12/28/20 and developed symptoms that evening chills, subjective fever, arm soreness with increased warmth and nodule, and fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Nodule', 'Pain in extremity', 'Pyrexia', 'Skin warm', 'Vomiting']",1,MODERNA,IM 961860,,31.0,F,"Headache, Myalgia, Arthralgia, Fever, Rash, NauseaVomiting Fatigue Narrative: Able to to to work. Hx of COVID 9/18/2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,11/25/2019,12/26/2020,397.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Rash', 'Vomiting']",1,MODERNA,IM 961861,,55.0,M,SkinRash,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,OTH,,,,,,['Rash'],1,PFIZER\BIONTECH,IM 961862,,30.0,M,"Headache, Myalgia & Arthralgia",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Myalgia']",1,MODERNA,IM 961863,,40.0,F,Sore arm at site of injection only Narrative: Sore arm at site of injection only,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Injection site pain'],1,MODERNA,IM 961864,,39.0,F,"HYPERtension tingling lips Narrative: presented back to vaccine clinic 25 minutes after administration with c/o tingling lips. B/P 144/96, HR 78, O2 99% at 10:13, Benadryl 25 mg PO at 10:15. BP 140/87 at 10:20. Lips no longer tingling at 10:35. 10:39 BP 118/77, HR 76, O2 99%. No further monitoring needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/29/2020,,OTH,,,,,,"['Hypertension', 'Paraesthesia oral']",1,MODERNA,IM 961865,,53.0,F,"Headache, Myalgia, Arthralgia, Received COVID Vaccine 12/28 and developed symptoms 1 hour post-vaccination including nasal congestion, chills,and left arm soreness with a nodule at site of injection. Employee has chronic neck and back pain which were worsened after receiving the vaccine. The medications the employee is taking are her chronic meds for her chronic eck and back pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Arthralgia', 'Back pain', 'Chills', 'Condition aggravated', 'Headache', 'Injection site nodule', 'Myalgia', 'Nasal congestion', 'Neck pain', 'Pain in extremity']",1,MODERNA,IM 961866,,48.0,F,"Rash localized pain in area of injection Narrative: Reports awoke day after receiving vaccine with ""hot and raised"" rash surrounding area of injection. measure 4.5 * 3.5 cm, red, blotchy, slightly itchy rash, skin intact, no other clinical findings with regard to rash. She reports localized tenderness in area of rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/29/2020,,OTH,,,,,,"['Injection site pain', 'Injection site rash', 'Rash macular', 'Rash papular', 'Rash pruritic', 'Tenderness']",1,MODERNA,IM 961867,,33.0,F,"Headache, Myalgia, Arthralgia & Diarrhea Narrative: Resolved symptoms in 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Arthralgia', 'Diarrhoea', 'Headache', 'Myalgia']",1,MODERNA,IM 961868,,34.0,M,"Headache, CoughWheeze, congestion",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/28/2020,5.0,OTH,,,,,,"['Cough', 'Headache', 'Respiratory tract congestion', 'Wheezing']",1,MODERNA, 961870,,61.0,F,Arthralgia fatigue Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/23/2020,2.0,OTH,,,,,,"['Arthralgia', 'Fatigue']",1,PFIZER\BIONTECH,IM 961871,,44.0,F,"injection site at upper deltoid, Pain in mid shoulder with ROM above >90 13:30, at 15:30 pain increased in left shoulder with AROM. Shoulder and back warmth. Numbness in left cheek and left lip. All resolved, mild with arm pain with turning apply force c Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,OTH,,,,,,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Injection site pain', 'Injection site warmth', 'Pain', 'Pain in extremity', 'Skin warm']",UNK,MODERNA, 961873,,49.0,F,"Headache, Myalgia, Arthralgia, CHILLS Narrative: Employee was sent home from work",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Impaired work ability', 'Myalgia']",UNK,MODERNA,IM 961874,,40.0,M,feeling flush,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/28/2020,,OTH,,,,,,['Flushing'],1,MODERNA,IM 961875,,58.0,F,"Headache, Myalgia, Arthralgia, NauseaVomiting, Symptoms started evening 12/28/20 -Nasal Congestion Started, Arm soreness,Denies Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,She gets similar symptoms with annual influenza vaccine.,,"['Arthralgia', 'Headache', 'Myalgia', 'Nasal congestion', 'Nausea', 'Pain in extremity', 'Vomiting']",1,MODERNA,IM 961877,,28.0,F,"Headache, Myalgia, Fever, fatigue, feels hot but temp is normal. Narrative: 12/28 onset of ""feeling crummy"" - fatigue and ""really bad"" headache. She went home after work and went to sleep. 12/29 onset of feeling ""hot"" but her temperature is normal. Body aches, slight headache, and feeling ""clammy"". She took ibuprofen on 12/29 and is currently at work. Employee reports she usually feels mildly ill the day after a flu vaccine but this adverse reaction is much worse than that. 12/30 - employee reports she developed diarrhea and a temp to 99. Continues to have body aches and mild headache. 12/31 all symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Cold sweat', 'Diarrhoea', 'Fatigue', 'Feeling hot', 'Headache', 'Myalgia', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 961878,,24.0,F,"Myalgia, Fever, chills Narrative: Missed 1 d of work",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/25/2020,12/28/2020,3.0,OTH,,,,Similar symptoms follow influenza vaccine,,"['Chills', 'Impaired work ability', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 961880,,57.0,F,"Headache, Myalgia, Arthralgia & Fever Narrative: patients is too sick to come into work",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Impaired work ability', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 961881,,34.0,F,"Myalgia fatigue, itching/pain/erythema/swelling at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,OTH,,,,,,"['Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Myalgia']",1,MODERNA,IM 961883,,39.0,M,"URTICARIA/PRURITUS TO TORSO,BACK,CHEST",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/25/2020,2.0,OTH,,,,,,"['Pruritus', 'Urticaria']",1,MODERNA,IM 961885,,58.0,M,swollen glands around uvula,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/17/2020,1.0,OTH,,,,,,['Lymphadenopathy'],1,PFIZER\BIONTECH,IM 961886,,56.0,F,"swollen uvula, throat lymph edema, arm soreness. has history of anaphylaxis",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/22/2020,2.0,OTH,,,,,,"['Enlarged uvula', 'Pain in extremity', 'Pharyngeal oedema']",1,PFIZER\BIONTECH,IM 961887,,43.0,F,"Confusion, Headache, Myalgia & Fever Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Confusional state', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 961889,,56.0,F,Swollen lymph node to left axilla with tenderness; fatigue started 12/24/2020,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/28/2020,6.0,OTH,,,,,,"['Fatigue', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 961899,,59.0,F,"Tachycardia Narrative: VACCINE ADMINISTERED APPROX 1050AM, PT REPORTED PALPITATIONS AT APPROX 1102, VITAL SIGNS CHECKED, HER 110-120s, PT SENT TO ED VIA W/C ACCOMPANIED BY RN & MD",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/28/2020,,OTH,,,,,,"['Palpitations', 'Tachycardia']",1,PFIZER\BIONTECH,IM 961908,,38.0,F,LEFT ARM PAIN; LOCALIZED SWELLING/ERYTHEMA/AXILLARY LYMPHADENOPATHY LEFT Narrative: LEFT ARM PAIN: LOCALIZED SWELLING/ERYTHEMA/AXILLARY LYMPHADENOPATHY LEFT DEVELOPED 12-24 HRS POST VACCINATION- ALL SYMPTOMS RESOLVED 48 HRS LATER,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Erythema', 'Lymphadenopathy', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 961914,,48.0,F,"Myalgia, Fever, Sore throat, arm soreness Narrative: Symptoms reported 12/24 and Per Dr. visit report this employee felt well enough to work the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Myalgia', 'Oropharyngeal pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 961952,,27.0,F,"Dizziness, Myalgia & NauseaVomiting Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/28/2020,,OTH,,,,,,"['Dizziness', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 964306,,35.0,M,"Headache, Myalgia, NauseaVomiting, fever-100.3 F had two days of leave, rest at home",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/11/2020,12/23/2020,12.0,OTH,,,,,,"['Headache', 'Impaired work ability', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 964322,,60.0,F,"Headache, Myalgia, Fever, ErythemaMultiform, Pain in feet Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Erythema multiforme', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 964371,,56.0,F,"Rash, UrticariaPruritus, pain at site of injections x 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/28/2020,7.0,OTH,,,,,,"['Injection site pain', 'Rash pruritic', 'Urticaria']",1,MODERNA,IM 964378,,40.0,F,Headache pressure around head for 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,OTH,,,,,,"['Head discomfort', 'Headache']",1,PFIZER\BIONTECH,IM 964384,,69.0,M,"Arthralgia, Fever & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Arthralgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA, 964391,,50.0,F,"SkinRash, Rash, pain at injection site Approximately 4 hours after injection of Moderna COVID-19 vaccine to left arm employee started to experience pain to injection site that progressively got worse, to the point employee was not able to sleep on left side. Employee reports pain to injection as ""10"" on 0-10 scale at 0830 12/29/2020. In morning of 12/29/2020 employee noticed raised macular below injection site that is not itchy or painful. Size of rash 6 inches x 3 inches. Employee instructed to take picture of rash. Employee now concerned about getting second dose of COVID-19 vaccine. No medications used to treat pain or rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Injection site macule', 'Injection site pain', 'Injection site rash', 'Injection site swelling', 'Rash', 'Sleep disorder']",1,MODERNA,IM 964400,,23.0,F,"Headache, Myalgia, NauseaVomiting, Weakness Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Asthenia', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 964407,,62.0,M,"CoughWheeze congestion, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Cough', 'Fatigue', 'Respiratory tract congestion', 'Wheezing']",1,MODERNA, 964414,,62.0,M,"Headache, Myalgia, Diarrhea, NauseaVomiting, N/A Narrative: 1030hours received dose. 1130hours developed HA not alleviated with OTC Acetaminophen. 1200hours upset stomach, not alleviated with ""jell-o"" and clear soda, developed nausea. Had 4-5 bouts of BMs from time of dose to 1300hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/28/2020,,OTH,,,,,,"['Abdominal discomfort', 'Diarrhoea', 'Frequent bowel movements', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 964425,,48.0,M,"10 minutes after injection started having metallic taste, pressure to the left back tongue, left arm heaviness and fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/28/2020,,OTH,,,,,,"['Dysgeusia', 'Fatigue', 'Limb discomfort', 'Tongue discomfort']",1,MODERNA,IM 964428,,59.0,F,"tingling LUE, LLE, Left face and left side of tongue/cheek Narrative: condition C called",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/28/2020,,OTH,,,,,,"['Paraesthesia', 'Paraesthesia oral']",UNK,PFIZER\BIONTECH, 964435,,45.0,M,LEFT ARM PARASTHESIA HAD MILD TINGLING DOWN LEFT ARM,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/28/2020,,OTH,,,,,,['Paraesthesia'],1,PFIZER\BIONTECH,IM 964442,,59.0,F,"Angioedema, ErythemaMultiform, Employee reported on inhalation at the right upper lung lobe Narrative: Employee reported redness and swelling at the vaccination area. She also reported mild to moderated pain at the right upper lung lobe which occurs during inhalation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/28/2020,5.0,OTH,,,,,,"['Angioedema', 'Erythema multiforme', 'Injection site erythema', 'Painful respiration', 'Pulmonary pain', 'Vaccination site swelling']",1,MODERNA,IM 964448,,41.0,M,Diarrhea & NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Nausea', 'Vomiting']",UNK,MODERNA,IM 964450,,59.0,F,"ErythemaMultiform & UrticariaPruritus Narrative: URTICARIA, RASH HEAD TO TOE, PRURITUS after COVID Vaccine was given (evening)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Erythema multiforme', 'Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 964457,,32.0,F,"Headache, Fever, NauseaVomiting, Dx with COVID in September 2020 Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Headache', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 964462,,53.0,F,"UrticariaPruritus Narrative: Mild reaction R Arm and Left leg w/mild urticaria. Treated with 25mg Benadryl oral, observed for additional 30 minutes and released to home feeling well",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Pruritus', 'Urticaria']",1,MODERNA,IM 964475,,45.0,F,"Headache, ErythemaMultiform, UrticariaPruritus, NauseaVomiting, chills, body aches, abdominal pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Abdominal pain', 'Chills', 'Erythema multiforme', 'Headache', 'Nausea', 'Pain', 'Pruritus', 'Urticaria', 'Vomiting']",1,MODERNA,IM 964482,,52.0,F,"Headache, Myalgia, Fever, INJECTION SITE PAIN, STIFFNESS, PAINFUL LN B/L, JOINT PAIN TEMP 99.3 Narrative: 12/25-mile injection site pain 12/26-increased injection site pain, stiffness, painful lymph nodes on both sides, headache, body aches, joint pain and 99.3 temp. Completely resolved by 12/27",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,"['Arthralgia', 'Body temperature increased', 'Headache', 'Injection site pain', 'Lymph node pain', 'Musculoskeletal stiffness', 'Myalgia', 'Pain', 'Pyrexia']",1,MODERNA,IM 964491,,29.0,F,"Headache, Myalgia, NauseaVomiting, Chills, lethargic",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,"['Chills', 'Headache', 'Lethargy', 'Myalgia', 'Nausea', 'Vomiting']",UNK,MODERNA,IM 964501,,51.0,F,"injection site pain, lymphadenopathy Narrative: 12/18 received the vaccine. 12/19 injection site and upper arm pain. 12/20 onset of supraclavicular lymphadenopathy. Still present 12/28. Nodes are palpable, mobile, and non-tender.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/19/2020,1.0,OTH,,,,,,"['Injection site pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 964509,,39.0,F,eye twitching,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/23/2020,,OTH,,,,,,['Blepharospasm'],UNK,MODERNA, 964521,,1.08,F,Bleeding Epistaxis Narrative: Epistaxis shortly after getting the vaccine. Required UC visit to get it under control. Per MD note bleeding stopped after applying pressure for 15 minutes,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Epistaxis'],1,MODERNA,IM 964524,,43.0,F,"Myalgia, Diarrhea, LEFT deltoid, soreness redness and lump RESOLVED 12/28. periorbital edema/upper eyelids, diarrhea, myalgia and fatigue 12/25 all resolved 12/28. upper eyelids conts Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Eyelid oedema', 'Fatigue', 'Injection site erythema', 'Injection site mass', 'Injection site pain', 'Myalgia', 'Periorbital oedema']",1,MODERNA,IM 964539,,41.0,F,"Headache & Fever Narrative: Emp reports he had COVID vaccine Sat 12/26/20 and started running fever of 101.8 12/27/20. Emp states he checked his temp again today and now is 101.6. Emp reports he had COVID in June 2020. Emp states he called out of work today due to fever and is seeking further instructions on what to do next. Feels better, now, but still has headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/27/2020,1.0,OTH,,,,,,"['Headache', 'Impaired work ability', 'Pyrexia']",1,MODERNA,IM 964547,,52.0,M,"Headache, Myalgia, Arthralgia, Fever, Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 964555,,62.0,F,"Headache, CoughWheeze & NauseaVomiting Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Cough', 'Headache', 'Nausea', 'Vomiting', 'Wheezing']",1,MODERNA,IM 964561,,35.0,F,"Headache, Myalgia, Fever, CoughWheeze, NauseaVomiting, Fever 99.8 12/25 Sore throat 12/25 Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Cough', 'Headache', 'Myalgia', 'Oropharyngeal pain', 'Pyrexia', 'Wheezing']",1,MODERNA,IM 964567,,46.0,M,"Dizziness, Headache, Myalgia, Arthralgia, Headache Narrative: Worsening of chronic dizziness, and left arm pain (elbow, thumb), also had a severe headache on 12/27 (resolved several hours after taking Tylenol).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Arthralgia', 'Condition aggravated', 'Dizziness', 'Headache', 'Myalgia', 'Pain in extremity']",1,MODERNA,IM 964575,,51.0,M,"Dizziness, Headache, Nausea, NauseaVomiting, swelling pain at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,"['Dizziness', 'Headache', 'Injection site pain', 'Injection site swelling', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 964578,,58.0,F,"Headache, Arthralgia, Sever Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Headache']",1,MODERNA,IM 964579,,52.0,F,"Rash Rash to bilateral upper extremities, pruritus to bilateral lower extremities, fine, blanching rash Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,OTH,,,,,,"['Pallor', 'Pruritus', 'Rash']",1,MODERNA,IM 964580,,43.0,F,"Headache, Myalgia & Arthralgia Narrative: Mild symptom onset, presented to clinic to report. No further actions.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/21/2020,0.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Myalgia']",UNK,PFIZER\BIONTECH,IM 964581,,27.0,M,"Myalgia, Arthralgia, Fever, 100.1 fever. extreme fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/27/2020,1.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 964582,,49.0,F,UrticariaPruritus,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 964583,,47.0,M,"Myalgia, Tachycardia, fatigue, soreness at the injection site. Narrative: 12/21 employee received vaccine at 0930 - later in the afternoon he noted tachycardia to about 100. He was watching the rate on his Apple watch. The highest rate was 130. His only other symptom was fatigue which was bad enough on 12/22 that he had to go home. He saw his PCP on 12/22 for the tachycardia who ordered labs which were all normal. He is a resident so he asked anesthesia to do an EKG which showed sinus tachycardia. On 12/23 his heart rate average went down to 100. Today (12-28) his resting heart rate is 70-80 which is his baseline. He has not had recurrence of the tachycardia since 12/23. He also reports he had soreness at the injection site and myalgias both of which have since resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,"['Electrocardiogram', 'Fatigue', 'Injection site pain', 'Myalgia', 'Tachycardia']",UNK,PFIZER\BIONTECH,IM 964584,,57.0,F,"Dizziness, Headache, Myalgia, Fever, NauseaVomiting, Intermittent jaw pain and rib pain Narrative: Recommended that she seek emergent care",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Dizziness', 'Headache', 'Musculoskeletal chest pain', 'Myalgia', 'Nausea', 'Pain in jaw', 'Pyrexia', 'Vomiting']",UNK,PFIZER\BIONTECH, 964585,,55.0,F,"Rash fatigue; induration, pain and erythema at inoculation site on left arm Narrative: seen by MD on 12/28/2020 for persistent induration and erythema/pain though decreasing induration/erythema size",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/26/2020,0.0,OTH,,,,,,"['Fatigue', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Rash']",1,MODERNA,IM 964586,,49.0,M,"Headache, Myalgia, Photophobia, fatigue Narrative: Onset about 8 hours after receiveing vaccine. 24 after vaccine, H/A is much improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia', 'Photophobia']",1,MODERNA,IM 964587,,54.0,F,"Headache, Rash & NauseaVomiting Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Headache', 'Nausea', 'Rash', 'Vomiting']",1,MODERNA,IM 964588,,37.0,F,"sinus congestion, pain at injection site Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Injection site pain', 'Sinus congestion']",1,PFIZER\BIONTECH,IM 964592,,63.0,M,"Headache, Myalgia, Arthralgia, Flu-like symptoms, woke up slightly restless on eve of 23rd, increased nasal congestion, profound fatigue following 48hrs difficult moving/getting out of bed, severe low back pain, left deltoid sore x 3 days, chills no documented fever, alternating Acetam Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Arthralgia', 'Back pain', 'Chills', 'Fatigue', 'Headache', 'Influenza like illness', 'Injection site pain', 'Myalgia', 'Nasal congestion']",1,MODERNA,IM 964603,,39.0,F,"Headache, Myalgia, NauseaVomiting, Chills, fatigue, decreased appetite, decreased ability to taste on 12/26-present Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Taste disorder', 'Vomiting']",1,MODERNA,IM 964615,,34.0,F,"Headache, NauseaVomiting, lightheadedness, throat numbness, facial tingling Narrative: 12/28 Onset of lightheadedness within 5 minutes of vaccine followed by nausea. After 35 min she felt tingling on her face and felt like her throat was numb. She drank water with no problem. She checked her O2 sat and it remained 91 - 93%. She just had an O2 meter because her Mother-in-law gave it to her. No underlying lung problem. She continues to have mild nausea but other symptoms have resolved. She has been able to eat some food which is making her feel better. She says she is developing tenderness in her temples which feels like she's developing a headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Dizziness', 'Headache', 'Nausea', 'Paraesthesia', 'Pharyngeal hypoaesthesia', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 968200,,54.0,F,Headache Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Headache'],UNK,MODERNA, 968206,,69.0,M,"Sedation, Myalgia, Fever, extensive fatigue, low grade fever, and myalgia reported Narrative: Employee needed to leave work second to symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Fatigue', 'Impaired work ability', 'Myalgia', 'Pyrexia', 'Sedation']",2,PFIZER\BIONTECH,IM 968216,,54.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 968222,,61.0,F,"Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had immediate pain at the injection site. On Saturday at 7AM, she developed malaise and frequent stools but would not classify them as diarrhea as well as a headache. She has never had a fever. Today, she continues to feel weak but reports that she is improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,OTH,,,,,,"['Asthenia', 'Frequent bowel movements', 'Headache', 'Immediate post-injection reaction', 'Injection site pain', 'Malaise']",UNK,PFIZER\BIONTECH, 968226,,53.0,M,Headache malaise Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,OTH,,,,,,"['Headache', 'Malaise']",UNK,MODERNA, 968233,,75.0,F,MILD URTICARIA Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,['Urticaria'],1,PFIZER\BIONTECH,IM 968234,,50.0,M,injection site pain,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/23/2020,1.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA,IM 968239,,44.0,F,facial numbeness x 1h; bilateral Narrative: self limited bilateral facial numbness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Hypoaesthesia'],UNK,PFIZER\BIONTECH,IM 968245,,42.0,F,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA,IM 968250,,41.0,F,injection site pain,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/23/2020,1.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA,IM 968256,,61.0,F,"Headache, Myalgia, Arthralgia, decreased appetite, general malaise, some abdominal discomfort",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/17/2020,,OTH,,,,,,"['Abdominal discomfort', 'Arthralgia', 'Decreased appetite', 'Headache', 'Malaise', 'Myalgia']",1,PFIZER\BIONTECH,IM 968263,,57.0,M,"Headache, Rash, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Rash']",1,PFIZER\BIONTECH,IM 968266,,50.0,M,injection site pain Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/23/2020,1.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 968267,,35.0,M,"Headache, Myalgia & Diarrhea Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,OTH,,,,,,"['Diarrhoea', 'Headache', 'Myalgia']",1,PFIZER\BIONTECH,IM 968268,,52.0,F,injection site pain Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/23/2020,1.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA,IM 968269,,52.0,F,"Dizziness, Headache & Myalgia Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Dizziness', 'Headache', 'Myalgia']",1,MODERNA,IM 968270,,35.0,M,Leak of vaccine from needle / syringe Narrative: Leak from syringe / needle during administration of vaccination. Moderna contacted with the following recommendations: 1) Monitor patient for 30 minutes post vaccination. 2) No need to repeat vaccination and proceed with vaccination #2 per recommended schedule.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Syringe issue'],1,MODERNA,IM 968271,,58.0,M,Myalgia injection site pain Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Injection site pain', 'Myalgia']",UNK,MODERNA,IM 968272,,33.0,F,"Dizziness Narrative: About one hour after shot, developed dizziness, which continues at this time (2 hours). Hasn't fallen, gait is stable, hasn't taken any meds.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Dizziness'],1,MODERNA,IM 968273,,44.0,F,"Myalgia bottom lip feels heavy, jaw feels heavy, bottom lip and jaw numbness Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,"['Discomfort', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Myalgia']",1,PFIZER\BIONTECH,IM 968274,,64.0,F,pain and swelling at the injection site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Injection site pain', 'Injection site swelling']",UNK,MODERNA,IM 968275,,61.0,M,injection site pain Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/23/2020,1.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA,IM 968631,,59.0,F,"Headache, Myalgia, Arthralgia, Fever, chills, fatigue, injection site pain Narrative: Employee reported injection site pain on arm, as well as fever (101 F), chills, joint pain, muscle pain/body aches, and fatigue. Reports took ibuprofen (unknown dose/frequency).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 970331,,58.0,M,"Fever chills and low grade fever at bedtime, slight throat irritation with dry cough Narrative: Low grade fever, body aches, chills, body aches are the worse.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Chills', 'Cough', 'Pain', 'Pyrexia', 'Throat irritation']",1,PFIZER\BIONTECH,IM 970332,,51.0,F,"Headache, Fever, Chills, Cramping T101.4 Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,OTH,,,,,,"['Body temperature increased', 'Chills', 'Headache', 'Muscle spasms', 'Pyrexia']",1,MODERNA,IM 970349,,41.0,M,ErythemaMultiform Narrative: blister at site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,OTH,,,,,,"['Erythema multiforme', 'Injection site vesicles']",1,MODERNA,IM 970350,,41.0,F,"Headache, Myalgia, extreme fatigue, joint pain unable to complete household work. Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/25/2020,2.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Loss of personal independence in daily activities', 'Myalgia']",1,PFIZER\BIONTECH,IM 970397,,38.0,F,"Headache, Myalgia, Arthralgia, NauseaVomiting, Fatigue, Chills Narrative: Treated with acetaminophen and rest",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,UNK,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 970403,,40.0,F,"throat itching and mild throat swelling Narrative: aprox 40 mins ater vaccine,pt c/o throat itching and slight throat swelling.pt give PO 25 mg Benadryl with ease of symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/28/2020,,OTH,,,,,,"['Pharyngeal swelling', 'Throat irritation']",1,MODERNA,IM 970407,,33.0,F,"Headaches, Rash, locallized pain in area of shot, axillary tenderness. Narrative: Employee reports day after shot, developed headache, localized pain in area of shot, mild pain in axilla on side of shot, and small rash, red, about the size of quarter. Headache resolved within a day, localized pain resolved within a few days. Rash and mild axillary pain continues at day 6, rash has increased to 5cmx6cm, red, blotchy, flat, no sloughing.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Axillary pain', 'Erythema', 'Headache', 'Injection site pain', 'Pain', 'Rash', 'Rash erythematous', 'Rash macular', 'Tenderness']",1,MODERNA,IM 970413,,47.0,F,"Dizziness, Diarrhea, HYPERtension & Tachycardia Narrative: Employee felt flushed, tachy and dizzy. Initial vitals BP 180/116, P 125, Pulse Ox 100%. Given ice pack and monitored symptoms & vitals. No medications/treatment provided. Employee notes h/o stress induced HTN, no medications. Smoker, last >2 hours prior. BP and Pulse remained elevated and employee was transferred to the ED for further monitoring.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/28/2020,,OTH,,,,,,"['Blood pressure increased', 'Diarrhoea', 'Dizziness', 'Flushing', 'Heart rate increased', 'Hypertension', 'Stress', 'Tachycardia']",1,MODERNA,IM 970419,,27.0,M,Myalgia Fatigue Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/25/2020,12/28/2020,3.0,OTH,,,,,,"['Fatigue', 'Myalgia']",1,MODERNA,IM 970428,,48.0,M,"Headache, Fever, NauseaVomiting, FATIGUE, TIRED, fever, HA, nausea, vomiting, swollen glands",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,"same, got the flu shot 47, 11/20/20, quadrivalent",,"['Fatigue', 'Headache', 'Lymphadenopathy', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 970440,,61.0,F,Headache Narrative: headache resolved during observation period,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Headache'],1,MODERNA,IM 970445,,52.0,M,"Headache, HYPERtension, congestion Narrative: home to take daily zyrtec for congestion;",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Headache', 'Hypertension', 'Respiratory tract congestion']",1,MODERNA,IM 970452,,42.0,F,"Headache, HYPERtension, neck stiffness, left arm weakness, Narrative: individual states having these symptoms all the time, almost resolved when left with husband driving home",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Headache', 'Hypertension', 'Muscular weakness', 'Musculoskeletal stiffness']",1,MODERNA,IM 970520,,38.0,M,Diarrhea Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,,,,,,['Diarrhoea'],UNK,MODERNA, 970521,,66.0,F,"CoughWheeze, NauseaVomiting, fatigue, shortness of breath, sore throat Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/25/2020,12/25/2020,0.0,OTH,,,,,,"['Cough', 'Dyspnoea', 'Fatigue', 'Nausea', 'Oropharyngeal pain', 'Vomiting', 'Wheezing']",1,MODERNA,IM 970522,,30.0,F,UrticariaPruritus itching only at site of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Injection site pruritus', 'Injection site urticaria']",1,MODERNA,IM 970523,,60.0,F,Diarrhea Headache Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Headache']",1,PFIZER\BIONTECH,IM 970524,,32.0,F,"Dizziness, Myalgia, Fever, SkinRash, NauseaVomiting, Palpitations, Tachycardia, Tingling throat, lips, tongue. Lip swelling. Severe arm pain at site, sore throat, nasal congestion",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Dizziness', 'Injection site pain', 'Lip swelling', 'Myalgia', 'Nasal congestion', 'Nausea', 'Oropharyngeal pain', 'Palpitations', 'Paraesthesia oral', 'Pharyngeal paraesthesia', 'Pyrexia', 'Rash', 'Tachycardia', 'Vomiting']",1,MODERNA, 970525,,49.0,M,Throat felt tight Narrative: Throat felt tight. No wheezes/rhonci. Tongue without edema. Able to swallow. O2SAT 100% Vitals wnl,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Throat tightness'],1,MODERNA,IM 970526,,31.0,F,"Dizziness, Tachycardia, neck/throat pressure on right side Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Dizziness', 'Musculoskeletal discomfort', 'Tachycardia', 'Throat tightness']",1,MODERNA,IM 970527,,38.0,F,SORENESS AT INJECTION SITE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA,IM 970528,,27.0,F,"Headache, Myalgia, Arthralgia, Fever, Diarrhea, chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Diarrhoea', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 970529,,61.0,F,"Headache, Myalgia, CoughWheeze & NauseaVomiting Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Cough', 'Headache', 'Myalgia', 'Nausea', 'Vomiting', 'Wheezing']",UNK,MODERNA, 970530,,,M,"Myalgia, NauseaVomiting, Fatigue Narrative: I took my second shot yesterday around noon felt pretty tired around 10 PM and 2 o'clock was aching like crazy..i've been taking Tylenol and NSAIDS and tums. And I took twice tramadol 50 mg left over from five years ago. The only relief was a short gag throw up a few minutes ago. I i'm lucky I took the day off today and tomorrow. I think by early afternoon I'll be able to get back on the computer. But there was no way I could talk to anybody this morning. Even my hair hurts. Feel dehydrated.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Fatigue', 'Myalgia', 'Nausea', 'Pain', 'Pain of skin', 'Retching', 'Vomiting']",2,PFIZER\BIONTECH,IM 970531,,61.0,F,FATIGUE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Fatigue'],UNK,MODERNA,IM 970532,,45.0,F,"Headache, Myalgia, CoughWheeze, Diarrhea, NauseaVomiting, Tachycardia, Chills, Joint Pain, Very Sore Arm Narrative: Per received email from initial person reporting the ADR- ""The Chief Medical Officer came to assess her. It is my understanding that she was subsequently tested for COVID19 on 1/3/2021 and determine to be positive. It is unknown if there were any other appointments attended by the employee.""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Arthralgia', 'COVID-19', 'Chills', 'Cough', 'Diarrhoea', 'Headache', 'Myalgia', 'Nausea', 'Pain in extremity', 'SARS-CoV-2 test positive', 'Tachycardia', 'Vomiting', 'Wheezing']",1,MODERNA,IM 970533,,28.0,M,"Headache, Myalgia, Fever, chills, Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA, 970534,,39.0,M,"Headache chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache']",UNK,MODERNA, 970535,,58.0,F,SORENESS AT INJECTION SITE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA,IM 970536,,58.0,M,Dizziness Narrative: became pale. Minimal breakfast.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Dizziness', 'Pallor']",1,MODERNA,IM 970537,,53.0,F,"Myalgia fatigue, fever, Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Fatigue', 'Myalgia', 'Pyrexia']",UNK,MODERNA, 970538,,53.0,F,ErythemaMultiform Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,,01/06/2021,,OTH,,,,,,['Erythema multiforme'],1,MODERNA,IM 970539,,28.0,F,Palms became sweaty Narrative: Noted palms becoming sweaty after 30 minutes of having the vaccine. Initial blood pressure 86/55 P 84 (lying down) with 97 O2 Sat. Denied difficulty breathing. Interval blood pressure 97/57 p. 83 regular. Final blood pressure 137/74 (sitting) P. 90. Left in stable condition to continue being a part of the COVID vaccination team as check-out.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Hyperhidrosis'],1,MODERNA,IM 970540,,30.0,F,"periorbital edema, lip swelling Narrative: ED note: This is a 29 year old employee who got her COVID vaccine yesterday. This morning she noticed facial puffiness, mostly around her eyes. No swelling of lips, toungue, no trouble swallowing or speaking, no swelling of throat, no SOB, no n/v or dizziness. Here she had some mild periorbital puffiness that I would not be aware of if she did not point it out to me. There is no swelling of her lips, airway and no SOB or problems with her voice. Her symptoms are improving in the ER. I think it is unlikely that this delayed symptom is related to the vaccine, however, she also states she had some swelling of the right side of her lip yesterday (none today), so I'm going to prescribe her an epi-pen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Eye swelling', 'Lip swelling', 'Periorbital oedema', 'Periorbital swelling', 'Swelling face']",UNK,PFIZER\BIONTECH,IM 970541,,34.0,F,"Dizziness, Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, HYPERtension, fatigue, injection site pain/itching, chills Narrative: Employee reports feeling dizzy and ""foggy"" about 3 hours after receiving vaccine. Also reports nausea, diarrhea, headaches, fever/chills, fatigue, muscle aches, and injection site pain/itching. No medications taken for symptoms relief per report.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Chills', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Headache', 'Hypertension', 'Injection site pain', 'Injection site pruritus', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 970542,,29.0,F,"Dizziness, HYPERtension, elevated blood pressure Narrative: dizziness 10 min after injection and by was 139/75.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/26/2020,,OTH,,,,,,"['Dizziness', 'Hypertension']",1,MODERNA,IM 970543,,60.0,F,"Fever 12/24/20 @12:30 am woke up with severe chills (rigors) lasted 3 hours max was 103.7 f, extremely tiredness. 12/25/20 @ 12:00 midnight all symptoms resolved, fever gone. 12/25/20- much better just a little tired. Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Pyrexia']",1,MODERNA,IM 970553,,54.0,F,"Headache, Myalgia, Fever, Diarrhea, NauseaVomiting & Tachycardia Narrative: Vaccine received on 12-19-20. Symptom onset several hours later, needed to miss work on Monday 12-21-20 on account of symptoms. No immediate medical intervention required. Self-managed with tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Headache', 'Impaired work ability', 'Myalgia', 'Nausea', 'Pyrexia', 'Tachycardia', 'Vomiting']",1,PFIZER\BIONTECH,IM 970558,,36.0,F,"Dizziness lightheaded and sore throat, injection site soreness Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/26/2020,,OTH,,,,,,"['Dizziness', 'Injection site pain', 'Oropharyngeal pain']",1,MODERNA,IM 970562,,53.0,F,"UrticariaPruritus, HYPERtension, itching Narrative: after 30 minutes, redness resolved, elevated blood pressure returned to normal",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Erythema', 'Hypertension', 'Pruritus', 'Urticaria']",1,MODERNA,IM 970566,,23.0,F,"Headache, NauseaVomiting, Chills, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 970570,,71.0,F,"TINGLING TO LEFT DELTOID Narrative: C/O TINGLING TO LEFT DELTOID AFTER ADMINISTRATION OF VACCINE - NOTIFIED OCCUPATIONAL HEALTH PROVIDER DENIES, PA PT DECLINED ASSESSEMENT BY ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Injection site paraesthesia'],1,PFIZER\BIONTECH,IM 970702,,,F,"Headache, Myalgia, pain of upper legs and arms and slight headache Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 970723,,31.0,F,"UrticariaPruritus sweating, fatique, lymph node swelling Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/17/2020,1.0,OTH,,,,yes-Flu vaccine,,"['Fatigue', 'Hyperhidrosis', 'Lymphadenopathy', 'Pruritus', 'Urticaria']",UNK,PFIZER\BIONTECH, 970754,,39.0,F,"Headache, Myalgia, Arthralgia, malaise Narrative: States she compares the side effects similar to those she experiences after having a Flu vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Malaise', 'Myalgia']",1,PFIZER\BIONTECH,IM 970771,,30.0,M,Myalgia fatigue Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Fatigue', 'Myalgia']",UNK,MODERNA, 970784,,56.0,F,"Headache TIREDNESS SAME DAY. NEXT DAY, BAD HEADACHE, BACK WAS HURTING. TODAY 01/05/21 JOINT PAIN WHEN I WOKE UP. LEFT ARM JOINT PAIN AT ELBOW AND AT WRIST AND MY HAND AND FINGERS Narrative: 2 DAYS OF SAFETY LEAVE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Arthralgia', 'Back pain', 'Fatigue', 'Headache']",UNK,PFIZER\BIONTECH,IM 970800,,43.0,M,Palpitations facial warmth Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,OTH,,,,,,"['Feeling hot', 'Palpitations']",1,PFIZER\BIONTECH,IM 970823,,42.0,F,SORENESS AT INJECTION SITE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA,IM 971042,,48.0,F,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 971051,,43.0,F,"Fever, Angioedema, SkinRash & Rash Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Angioedema', 'Pyrexia', 'Rash']",1,PFIZER\BIONTECH,IM 971055,,53.0,F,Headache & Fever Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Headache', 'Pyrexia']",1,PFIZER\BIONTECH,IM 971057,,43.0,F,"Headache, NauseaVomiting, ITCHY THROAT Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Headache', 'Nausea', 'Throat irritation', 'Vomiting']",1,MODERNA,IM 971059,,48.0,F,"Headache, Arthralgia, Fever, FLUSHED Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Arthralgia', 'Flushing', 'Headache', 'Pyrexia']",UNK,MODERNA,IM 971062,,43.0,F,"Rash & UrticariaPruritus Narrative: Employee states she took Benadryl, Pepcid and zantac on her own.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 971066,,43.0,F,NauseaVomiting & HYPERtension Narrative: nausea and elevated blood pressure 141/91; reclined in chair for 10 minutes; nausea resolved and BP decreased to 127/82.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Blood pressure increased', 'Hypertension', 'Nausea', 'Vomiting']",1,MODERNA,IM 971070,,27.0,M,"severe bilateral upper trapezius, bilateral quads soreness Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Abdominal pain upper'],1,PFIZER\BIONTECH,IM 971076,,55.0,F,UrticariaPruritus itching; r supraclavical tenderness and swelling began 12/28 - Narrative: reports r supraclavical tenderness and swelling begining on 12/28 for which she is taking advil.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Pruritus', 'Swelling', 'Tenderness', 'Urticaria']",1,MODERNA,IM 971081,,49.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 971087,,47.0,F,"Lightheadedness up the back of neck and scalp Narrative: Started feeling light headed up back of neck and scalp. B/P 119/84, P 76, R 16, O2 Sat 98%. Left walking fine and stated she was ok.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Dizziness'],1,MODERNA,IM 971093,,39.0,F,"FLUSHING Narrative: At approximately 1700 she was brought to the observation room due flushing of her face. Color was returning to normal but then she reclined in chair and stated that she was not feeling right. She reported feeling lightheaded and shaky. Pulse was regular, skin warm/dry. 1705 administered Benadryl 50mg PO. Monitored until 1735, stated she felt food and denied any issues.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Dizziness', 'Feeling abnormal', 'Flushing', 'Tremor']",UNK,MODERNA, 971095,,61.0,F,"Headache, Myalgia, Fever, HA, MYALGIA, PAIN AT SITE WHOLE ARM, Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Headache', 'Injection site pain', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 971101,,33.0,M,"Headache, Myalgia, Fever, Rhinorrhea, fatigue, chills. Narrative: Temp was up to 99.6.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia', 'Rhinorrhoea']",1,MODERNA,IM 971107,,63.0,F,"Headache, Myalgia, Arthralgia & NauseaVomiting Narrative: Is taking Ibuprofen/ Advil, also took Zofran for nausea. Body aches are 10/10, sometimes improve down to 8/10.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Vomiting']",1,PFIZER\BIONTECH,IM 971113,,34.0,F,"Paresthesia in lips, hands and feet 15 mins to 3 hours post vaccine Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,Had this reaction after taking a diuretic for altitude sickness-NOT a vaccine,,"['Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 971120,,53.0,F,"Headache, Arthralgia, foggy feeling, back ache Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Arthralgia', 'Back pain', 'Feeling abnormal', 'Headache']",2,PFIZER\BIONTECH,IM 971123,,26.0,M,"Myalgia, Fever Chills, abdominal pain(mild)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Abdominal pain', 'Chills', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 971136,,20.0,F,Tingling and numbness of the upper and lower lip (left side) Narrative: Patient stated she felt a slight tingling and numbness of left side of the lower and upper lip. Symptoms resolved after about 30 seconds post-vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Hypoaesthesia oral', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 971151,,30.0,M,"Headache, Myalgia, Arthralgia, NauseaVomiting, CHILLS/BODY ACHES/FATIGUE Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Vomiting']",1,PFIZER\BIONTECH,IM 971155,,59.0,F,"SkinRash, ErythemaMultiform, Hematoma Narrative: Hematoma forms on left arm after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Erythema multiforme', 'Injection site haematoma', 'Rash']",1,MODERNA,IM 971163,,61.0,U,"Dizziness Narrative: Felt dizzy, foggy. Vital signs within normal limits.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Dizziness', 'Feeling abnormal']",1,MODERNA,IM 971168,,47.0,F,Dizziness resolved after about an hour,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 971171,,52.0,F,"Dizziness, Headache, Myalgia & Diarrhea Narrative: Vaccinated in the morning 12/20. Fell asleep early due to fatigue. Woke up not feeling well: headache, body aches, dizzy. Unable to go to work that day. By Tuesday able to return to work though experiencing loose stools.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/21/2020,1.0,OTH,,,,,,"['Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Impaired work ability', 'Malaise', 'Myalgia', 'Pain']",1,PFIZER\BIONTECH,IM 971175,,53.0,F,"Myalgia bilateral leg and right ankle pain, reports calf tightness and cramping to lower extremities Narrative: developed bilateral leg pain, tightness of calf muscles within one hour of receiving vaccine. Headache on 12/23/2020",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Muscle spasms', 'Muscle tightness', 'Myalgia', 'Pain in extremity']",2,PFIZER\BIONTECH, 971200,,45.0,F,"Headache, Myalgia, NauseaVomiting, lethargy; injection site soreness, loss of appetite Narrative: Vaccine 12/17 @6:00 pm. On 12/18/2020 - woke up with a headache and ""tight"" muscles. Progressively that day she felt lethargic. She also had soreness in her arm at the site of the vaccine. Within 24 hours she developed nausea and lost her appetite. She took alleve and went back to sleep. 12/20 - slept all day. 12/21 - woke up feeling much better with a mild headache. 12/22 felt back to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,OTH,,,,,,"['Decreased appetite', 'Headache', 'Injection site pain', 'Lethargy', 'Muscle tightness', 'Myalgia', 'Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 971227,,35.0,M,injection site pain and swelling Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Injection site pain', 'Injection site swelling']",UNK,MODERNA,IM 971254,,55.0,F,Headache Narrative: 12/22 1300 vaccinated. 12/22 1430 onset of headache. 12/23 headache persists. No medication necessary to treat he headache. She denies all other symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,OTH,,,,,,['Headache'],UNK,PFIZER\BIONTECH,IM 971259,,1.5,F,metallic taste immediately; last for several hours--resolved. swelling/tenderness anterior neck/most likely lymphadenopathy Narrative: phone call,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Dysgeusia', 'Swelling', 'Tenderness']",1,PFIZER\BIONTECH,IM 971263,,54.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,OTH,,,,,,['Headache'],1,MODERNA,IM 971269,,38.0,F,"Headache, NauseaVomiting, Palpitations, felt palpitations about 90 min post vaccine; lasted for about 15 min; headach and mild nausea next morning Narrative: phone cal",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Headache', 'Nausea', 'Palpitations', 'Vomiting']",1,PFIZER\BIONTECH,IM 971289,,50.0,F,fatigue Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Fatigue'],UNK,MODERNA, 971290,,59.0,M,"Dizziness, Constipation, Extreme Fatigue, pain in arm form shot Narrative: Significant impact on life as he missed work due to this",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/21/2020,1.0,OTH,,,,,,"['Constipation', 'Dizziness', 'Fatigue', 'Impaired work ability', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 971291,,43.0,F,"Headache, NauseaVomiting, itchy throat Narrative: itchy throat, headache , nausea - resolved without intervention",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Headache', 'Nausea', 'Throat irritation', 'Vomiting']",1,MODERNA,IM 971292,,52.0,M,"Dizziness & HYPERtension Narrative: Patient reports light headedness, dizziness, ""heavy"" feeling to monitoring staff. Patient given some water and monitored for 30 minutes by monitoring staff. BP 139/111 HR 75, recheck BP 141/99 HR 80 reported to this RN. Event reported to this RN at 1350, patient returned to workstation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Discomfort', 'Dizziness', 'Hypertension']",1,PFIZER\BIONTECH,IM 971293,,35.0,M,"Syncope Narrative: Complaint of lightheadedness 15 seconds after administration of vaccine. Patient lowered to floor safely by RN, followed by syncope and loss of consciousness. EMS called. Patient returned to baseline oriented with stable vital signs following event. Patient left clinic in stable condition after monitoring by RN for approximately 1 hour.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Dizziness', 'Loss of consciousness', 'Syncope']",1,PFIZER\BIONTECH,IM 971294,,49.0,F,"Dizziness, Headache & Myalgia Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Dizziness', 'Headache', 'Myalgia']",1,MODERNA,IM 971295,,53.0,F,"Myalgia, Arthralgia & Tachycardia",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Arthralgia', 'Myalgia', 'Tachycardia']",1,MODERNA,IM 971296,,59.0,F,"Headache, Myalgia, Fever fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/17/2020,,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 971297,,46.0,F,UrticariaPruritus Narrative: Emp self admin diphenhydramine 25mg and issue resolved within 60min of taking med.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Pruritus', 'Urticaria']",1,MODERNA,IM 971298,,39.0,F,"Headache, Myalgia, Arthralgia, Fever, Fatigue Narrative: Significant impact on life, as symptoms result in time out of work",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,,,,Similar symptoms to first flu shot (2015),,"['Arthralgia', 'Fatigue', 'Headache', 'Impaired work ability', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 971299,,41.0,M,"Headache, Myalgia, injection site pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Headache', 'Injection site pain', 'Myalgia']",UNK,MODERNA, 971300,,31.0,F,"NauseaVomiting chiills, fatigue, nausea Narrative: phone call.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 971301,,,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 971302,,39.0,F,"UrticariaPruritus 3.5 x 4 cm painful, red, warm induration Narrative: immed small site rxn grew to 3.5 x 4 cm within 24hrs remains painful",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Immediate post-injection reaction', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site urticaria', 'Injection site warmth']",UNK,MODERNA,IM 971303,,68.0,M,"Dizziness Narrative: After 15mins observation ended, pt stood up and felt light headed; VS taken, BP 152/68, HR 71, O2Sat 100%; pt observed for another few mins and at 1130, she said she's feeling fine and ready to leave; declined to go to ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 971304,,31.0,M,"Headache & Myalgia Narrative: reports next morning felt like he was ""hit by a truck"" ""severe headache and muscle aches""On 12/31, things didn't get much better. I felt like I had the flu. I woke up in a puddle of sweat but I was freezing, I still had muscle aches and I had a sore throat. Friday was better beside still having a little bit of a sore throat. (symptoms lasted over 48 hours)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,unknown,,"['Headache', 'Hyperhidrosis', 'Myalgia', 'Nasopharyngitis', 'Oropharyngeal pain']",1,PFIZER\BIONTECH,IM 971305,,39.0,M,Myalgia lip burning Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Myalgia', 'Oral discomfort']",UNK,MODERNA, 971306,,51.0,F,"injection site redness/swelling/pain/itching, body aches Narrative: Employee reports experienced injection site pain/redness/swelling/itching after receiving vaccine. Unknown duration of how long symptoms persisted. Reports was taking ibuprofen (unknown dose/frequency) for 3-4 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/31/2020,8.0,OTH,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Pain']",1,MODERNA,IM 971307,,57.0,F,"Dizziness, Headache, NauseaVomiting, arm sore at injection site,fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 971308,,48.0,F,NauseaVomiting localized pain at injection site for 3 days Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/06/2021,9.0,OTH,,,,,,"['Injection site pain', 'Nausea', 'Vomiting']",1,MODERNA,IM 971309,,33.0,M,"Headache, Fever, NauseaVomiting, chills, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 971310,,62.0,M,"Headache, Myalgia, reports redness running down arm the afternoon of and today is feeling flush, and mild shortness of breath Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Dyspnoea', 'Erythema', 'Flushing', 'Headache', 'Myalgia']",1,MODERNA,IM 971311,,42.0,F,"Headache Fatigue Narrative: 24 hours after vaccine administration onset of headache, malaise, feeling poorly - subsequently missed work 12/22 in order to rest; resolved by 12/23",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/21/2020,1.0,OTH,,,,,,"['Fatigue', 'Feeling abnormal', 'Headache', 'Impaired work ability', 'Malaise']",1,PFIZER\BIONTECH,IM 971312,,51.0,F,"Headache, Myalgia, FATIGUE SORENESS AT INJECTOIN SITE AND SORE NECK",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Neck pain']",UNK,MODERNA,IM 971313,,52.0,F,"Myalgia, Arthralgia, Fever, chills, injection site pain Narrative: Employee reported experienced fever (101 F), chills, body aches, joint aches, headaches, and injection site pain the evening after receiving the vaccine. Reports took ibuprofen and Tylenol (unknown dose/frequency). Reports felt better after taking Motrin (ibuprofen).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,"body aches, chills, vomiting after receiving flu vaccine about 20 years ago",,"['Arthralgia', 'Chills', 'Headache', 'Injection site pain', 'Myalgia', 'Pain', 'Pyrexia']",1,MODERNA,IM 971314,,62.0,F,"Myalgia, UrticariaPruritus, injection site pain/redness/swelling/itching, chills, fever, body aches, fatigue, swollen lymph glands Narrative: Employee reports injection site pain/redness/swelling/itching, chills, fever, body aches, fatigue, and swollen lymph glands after receiving vaccine. No further information provided in report.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Lymphadenopathy', 'Myalgia', 'Pain', 'Pruritus', 'Pyrexia', 'Urticaria']",1,MODERNA,IM 971315,,60.0,F,"Headache, Myalgia, Arthralgia, severe fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia']",1,MODERNA,IM 971316,,56.0,F,"Headache, Myalgia, Arthralgia, Diarrhea, NauseaVomiting, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Arthralgia', 'Diarrhoea', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 971317,,46.0,F,"chest tightness Narrative: Per EOH RN email, employee experienced tightness to the chest about 15 minutes after injection. Employee was seen by doctor and was recommended to report to emergency room, however employee ""refused and left AMA."" On 12/24 (next day), employee denies any problems/issues and was not in any distress. Employee reports albuterol inhaler (1 puff one time) for shortness of breath.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Chest discomfort'],1,MODERNA,IM 971318,,54.0,F,FATIGUE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Fatigue'],UNK,MODERNA,IM 971323,,42.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 971324,,,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 971325,,57.0,F,"Myalgia Narrative: Employee reported experiencing arm pain/soreness/swelling (3-4/10 on pain scale), which began about 1 hour after vaccine administration and lasted about 3 hours. Reports resolved gradually over next couple of days. Reports on day 4 post-vaccination, developed a headache (""sinus pressure"") that progressed over 3 days to headaches, muscle aches, nausea, diarrhea, and general malaise. Employee also reported cough and runny nose on 12/28/2020. COVID test scheduled (results unknown as of date of this entry). Employee to contact PCP for sinus symptoms as has a history of allergies/sinus infections.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/23/2020,0.0,OTH,,,,"mild headache, body aches after flu vaccine a few years ago",,"['Cough', 'Diarrhoea', 'Headache', 'Malaise', 'Myalgia', 'Nausea', 'Pain in extremity', 'Paranasal sinus discomfort', 'Peripheral swelling', 'Rhinorrhoea']",1,MODERNA,IM 971326,,47.0,F,ErythemaMultiform swelling Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,OTH,,,,,,"['Erythema multiforme', 'Swelling']",1,MODERNA,IM 971327,,35.0,F,"flushing of face/body, redness and warmth to injection site Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Flushing', 'Injection site erythema', 'Injection site warmth']",1,MODERNA,IM 971330,,33.0,F,"ErythemaMultiform, UrticariaPruritus, swelling Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,OTH,,,,,,"['Erythema multiforme', 'Pruritus', 'Swelling', 'Urticaria']",1,MODERNA,IM 974780,,46.0,F,"Headache, Myalgia, Fever, chills, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 974781,,66.0,M,"Dizziness, NauseaVomiting, FELT HOT Narrative: PATIENT EXAMINED BY PHYSICIN AND NURSES. FOUND TO BE IN NSR AND SATTING IN THE 90'S WITH A BP OF 90/62. PATIENT STATED NORMAL VITAL SIGNS FOR HER. PATIENT HELD FOR ADDITIONAL 30 MIN AND RE-EXAMINED BY PHYSICIAN BEFORE BEING RELEASED FROM VACCINE CLINIC.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/06/2021,,OTH,,,,,,"['Dizziness', 'Feeling hot', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 974782,,56.0,M,"Headache, Myalgia & Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pyrexia']",UNK,MODERNA,IM 974783,,37.0,M,Headache Fatigue Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,OTH,,,,,,"['Fatigue', 'Headache']",1,MODERNA, 974784,,39.0,F,"Fever body aches Narrative: Per email from (EOH RN): ""employee had an adverse drug reaction on 12/23/2020, day after vaccination. Symptoms: fever, body aches"". Per Employee Adverse Reaction Report, employee also reports chills, headaches, joint pain, and fatigue. Employee reports max temp on 12/23/20 was 101-102 F, with fever breaking overnight. No symptoms other than mild soreness at injection site on 12/24/2020. Employee reported took extra strength Tylenol (500mg), 2 doses 6 hours apart.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,,,,"Employee reports following series 4 of anthrax vaccination, developed painful swelling, soreness, erythema and blisters at injec",,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 974785,,42.0,F,"Headache, Myalgia, Fever, Tachycardia, temp 104.0, chills, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia', 'Tachycardia']",2,PFIZER\BIONTECH,IM 977005,,38.0,F,"Myalgia menstrual irregularity Narrative: Employee reports was due for menstrual period on 12/25/2020 and had not started it as of 12/28/2020. Reports menses is regular (28-30days) and has not been sexually active in previous 2 months. Reports feels pre-menstrual, but no menses. Reported that several other coworkers also reported menstrual irregularities after receiving COVID vaccine. Employee also experienced ""severe pain 10/10"" to injection site for several days (pain 10/10 on day 1, 10/10 on day 2, 5/10 on day 3). Reports took Tylenol (unknown dose/frequency) but did not feel any relief. Injection site pain has since resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/25/2020,2.0,OTH,,,,,,"['Injection site pain', 'Menstruation irregular']",1,MODERNA,IM 977006,,53.0,F,Soreness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA,IM 977007,,58.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 977008,,60.0,M,"Dizziness, Headache, Arm sore and painful. C/O feeling eye pressure",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Dizziness', 'Headache', 'Ocular discomfort', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 977009,,57.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 977010,,59.0,M,Myalgia Local arm pain; neck and shoulder pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Arthralgia', 'Myalgia', 'Neck pain', 'Pain in extremity']",1,MODERNA,IM 977011,,49.0,M,"Myalgia Sore throat, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Myalgia', 'Oropharyngeal pain', 'Pain']",1,MODERNA,IM 977012,,62.0,F,"Headache, Myalgia chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia']",1,PFIZER\BIONTECH,IM 977013,,47.0,F,"Dizziness, headache, inj site 8 days after redness and pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Dizziness', 'Headache', 'Injection site erythema', 'Injection site pain']",1,MODERNA,IM 977014,,42.0,F,"chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Chills', 'Fatigue']",1,PFIZER\BIONTECH,IM 977015,,51.0,F,"Fever Narrative: The day after vaccine administration, employee experienced fever of 101.1 F, body aches, fatigue, and swollen glands under the chin. Max temp was 101.1 F at 6am on 12/23/2020, down to 98.8 F by 10am on 12/23/2020, after employee took ibuprofen 800mg x 3. Employee instructed to continue monitoring temperature and other symptoms, and to follow up with PCP if symptoms persist or condition worsens",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Fatigue', 'Lymphadenopathy', 'Pain', 'Pyrexia']",1,MODERNA,IM 977016,,32.0,F,NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Nausea', 'Vomiting']",UNK,MODERNA,IM 977017,,67.0,F,Dizziness & NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,,yes shingrex redness to inj area,,"['Dizziness', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 977024,,56.0,F,"Headache Fatigue, sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,yes,,"['Fatigue', 'Headache', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 977042,,67.0,F,Sore arm,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,OTH,,,,,,['Pain in extremity'],1,MODERNA,IM 977046,,35.0,M,Myalgia Narrative: Muscle aches and soreness from 12/31 to 1/1,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Myalgia'],1,MODERNA,IM 977052,,37.0,F,"Headache, Myalgia, NauseaVomiting, Fatigue, Sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain in extremity', 'Vomiting']",1,MODERNA,IM 977059,,46.0,M,Headache Chills,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Chills', 'Headache']",1,MODERNA,IM 977067,,58.0,F,"Headache, Myalgia, Rash, NauseaVomiting, fatigue Narrative: headache Dec 29-31, swelling and redness at site without pain started Jan 1 to current, fatigue Jan 1 to current, headache resumed Jan 3 to current, mild morning nausea starting Jan 4 to current, body aches Jan 4 to current mostly in ankles, knees and low back. Note she is also reporting directly to CDC herself",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Arthralgia', 'Back pain', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site swelling', 'Myalgia', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,IM 977076,,50.0,M,"Myalgia, Arthralgia, Swelling/heat/redness/injection pain/ fatigue/lightheadedness/increased urination Narrative: Used OTC naproxen",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/02/2021,2.0,OTH,,,,,,"['Arthralgia', 'Dizziness', 'Erythema', 'Fatigue', 'Injection site pain', 'Myalgia', 'Pollakiuria', 'Skin warm', 'Swelling']",1,MODERNA,IM 977083,,69.0,M,"Myalgia, Fever, feeling tired, scratchy throat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Fatigue', 'Myalgia', 'Pyrexia', 'Throat irritation']",UNK,MODERNA, 977089,,41.0,F,"Headache, Myalgia, CHILLS Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia']",UNK,MODERNA,IM 977095,,60.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 977100,,56.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,,,,['Headache'],UNK,PFIZER\BIONTECH, 977106,,53.0,M,"SEVERE BACK PAIN Narrative: Patient states he is in bed with ""severe back pain"" and has not reported to work today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,OTH,,,,,,['Back pain'],UNK,MODERNA,IM 977116,,58.0,M,"CoughWheeze, NauseaVomiting, restlessness/no sleep",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Cough', 'Insomnia', 'Nausea', 'Restlessness', 'Vomiting', 'Wheezing']",UNK,PFIZER\BIONTECH, 977125,,32.0,M,"Headache, Arthralgia, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Headache']",UNK,PFIZER\BIONTECH, 977133,,61.0,M,Headache Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Fatigue', 'Headache']",UNK,MODERNA,IM 977138,,45.0,M,"Myalgia Sore throat, fatigue, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,OTH,,,,unknown,,"['Fatigue', 'Myalgia', 'Oropharyngeal pain', 'Pain']",1,MODERNA,IM 977147,,50.0,M,"Headache, Myalgia, Tachycardia, Chills, Injection site pain Narrative: Took OTC ibuprofen and tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Chills', 'Headache', 'Injection site pain', 'Myalgia', 'Tachycardia']",1,MODERNA,IM 977154,,47.0,F,Headache Narrative: Took OTC ibuprofen,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,OTH,,,,unknown,,['Headache'],1,MODERNA,IM 977160,,43.0,F,pain at injection site. Just below left elbow to the tip of fingers c/o burning and has shooting pain sensation.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Burning sensation', 'Injection site pain', 'Pain']",1,PFIZER\BIONTECH,IM 977167,,40.0,F,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,,,,,,['Myalgia'],UNK,MODERNA,IM 977172,,28.0,F,Rash Itchy and red,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,OTH,,,,,,"['Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 977180,,39.0,F,"UrticariaPruritus Reported lip numbness c/ injection, reported to monitor no action. Employee left and called staff and reported hives on upper and lower lips, lips warm to touch Narrative: Reported lip numbness c/ injection, reported to monitor no action taken. Employee left after 15mins. Employee reported hives on upper and lower lips, lips warm to touch ( text message) no action taken",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Feeling hot', 'Hypoaesthesia oral', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 977188,,61.0,M,"Myalgia & Diarrhea Narrative: Per employee, 14 hours after vaccination, felt abdominal cramps followed by watery diarrhea and sore left arm (vaccine site). No hx of changes in food prep nor diet 1/1/2021. Denied fever, some sniffles (chronic) diarrhea improving bowel movement mid morning following day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,OTH,,,,,,"['Abdominal pain', 'Diarrhoea', 'Injection site pain', 'Myalgia', 'Rhinorrhoea']",1,PFIZER\BIONTECH,IM 977193,,62.0,F,"SkinRash & CoughWheeze Narrative: Patient with small rash on neck, Dr. in to evaluate, patient given 17:00 Benadryl 50mg PO , patient at 1730 having wheezing, congestion take to ER by nurse pules ox 97% breathing unlabored",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/05/2021,,OTH,,,,,,"['Cough', 'Rash', 'Respiratory tract congestion', 'Wheezing']",1,MODERNA,IM 977199,,39.0,F,Rash & UrticariaPruritus Narrative: Employee was self-treating with Benadryl and Zyrtec and has since followed up with primary care provider.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 977217,,27.0,F,"Myalgia & Fever Narrative: Pfizer covid 19 mRNA given 1/4/2021 left arm vaccination site (IM) at 1:17 pm complained of muscle soreness Left arm 09:00 pm 1/4/2021. The next day - morning felt tired, muscle soreness, Headache esp bifrontal and retrobulbar. T 99.7 taken this morning and took Ibuprofen 600mg one tablet this morning. She still reported for work today but complained about these symptoms to Supervisor who consulted EOH providers Denied cough nor colds nor any upper respiratory symptoms A/P: Vaccine related side effects within 24 hours after vaccination Reported to facility admin Can return to work if she feels better tomorrow but without taking analgesics (ibuprofen) nor antipyretics (Tylenol) Informed Supervisor",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 977224,,35.0,F,"Dizziness, Myalgia, Sensation of throat selling and itching Narrative: Employee self-treated at home with OTC Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Dizziness', 'Myalgia', 'Pharyngeal swelling', 'Throat irritation']",1,MODERNA,IM 977234,,59.0,F,"Chills on evening of day 1, and then injection site redness on day 9 (1/5/21) Narrative: Patient used over the counter tylenol to treat event (unclear whether it was on day 1 or day 9 of injection)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Chills', 'Injection site erythema']",1,MODERNA,IM 977244,,59.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 977253,,25.0,F,"Myalgia, Fever, CoughWheeze, NauseaVomiting, Sore throat, arm pain Narrative: MD visit 1/4/21. CBC and Covid antibodies obtained. Started on azithromycin. Fever resolved w/in in 12 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/25/2020,12/28/2020,3.0,OTH,,,,unknown,,"['Cough', 'Full blood count', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 antibody test', 'Vomiting', 'Wheezing']",1,MODERNA,IM 977272,,62.0,F,"Dizziness, Headache, Fever, NauseaVomiting, headache, lethargic, vomiting fever, body soreness, light-headed",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Dizziness', 'Headache', 'Lethargy', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",UNK,MODERNA,IM 977275,,39.0,M,muscle soreness at injection site with loss of range of motion X 30 hours; fatigue Narrative: teleophone call,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Fatigue', 'Injection site pain', 'Joint range of motion decreased']",1,PFIZER\BIONTECH,IM 977276,,47.0,M,"sore arm, swelling/""knot"" at injection stie; this has resolved. But still experiencing pain/limited range of motion 3 weeks post vaccine Narrative: pain and limited ROM of arm; she is seeking care through her pcp; xray of her arm has been ordered by her pcp",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/16/2020,0.0,OTH,,,,,,"['Injection site nodule', 'Injection site swelling', 'Joint range of motion decreased', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 977279,,58.0,F,Rash Hard red bump Narrative: Came to Occupational Health to have it looked at,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/31/2020,3.0,OTH,,,,,,"['Induration', 'Rash erythematous', 'Swelling']",1,MODERNA,IM 977284,,52.0,F,Headache Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,OTH,,,,,,['Headache'],1,MODERNA,IM 977289,,52.0,F,Rash 9x7 delayed induration at and below inj site onset 7d after inj Narrative: NO meds required. 7d delayed onset,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,OTH,,,,,,"['Injection site induration', 'Injection site rash', 'Injection site reaction', 'Skin reaction']",1,MODERNA,IM 977292,,40.0,M,"Headache, NauseaVomiting, FATIGUE Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Nausea', 'Vomiting']",UNK,MODERNA,IM 977295,,56.0,F,"arm pain swollen, red and itchy Narrative: no issues until 8 days later swollen red itchy arm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,OTH,,,,,,"['Erythema', 'Pain in extremity', 'Peripheral swelling', 'Pruritus']",1,MODERNA,IM 977302,,23.0,F,"Local induration, numbness ate injection site Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,OTH,,,,,,"['Injection site hypoaesthesia', 'Injection site induration']",1,MODERNA,IM 977304,,61.0,M,"Headache, Diarrhea, chills Narrative: headache, tenderness on the left side of neck, mild chills, diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Chills', 'Diarrhoea', 'Headache', 'Tenderness']",1,MODERNA,IM 977476,,50.0,M,Bruise and lump at iinjection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Injection site bruising', 'Injection site mass']",UNK,MODERNA,IM 977489,,58.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 977495,,53.0,M,Soreness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA,IM 977500,,58.0,F,"12/29-developed a severe sore throat; Wednesday, 12/30/2020 with runny nose and nasal congestion. She continues to be congested Narrative: 12/29-developed a severe sore throat; Wednesday, 12/30/2020 with runny nose and nasal congestion. She continues to be congested",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,OTH,,,,,,"['Nasal congestion', 'Oropharyngeal pain', 'Rhinorrhoea']",1,MODERNA,IM 977583,,30.0,M,Rash,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Rash'],1,MODERNA,IM 977591,,32.0,M,"Headache, NauseaVomiting, fever, chills, headache, N/V, bone aches, fatigue, SOB, injection site pain Narrative: Patient had COVID and recovered in March. Hx of asthma Was fine until vaccination on Monday. Reports experiencing all of the same side effects as when he had COVID: fever (101 F) nausea/ vomiting bone aches, chills, fatigue, chest tightness/SOB persistent headache injection site pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Bone pain', 'Chest discomfort', 'Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 977604,,44.0,M,"Headache, Myalgia, sore arm at injection site Narrative: phone call",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,reports not feeling well after getting flu shot earlier this year,,"['Headache', 'Injection site pain', 'Myalgia']",1,PFIZER\BIONTECH,IM 977612,,50.0,F,"Palpitations felt warm, skin flushing Narrative: Per EOH report on 12/23/2020: ""Employee had an adverse reaction pm 12/22/2020 on day of vaccination."" Report states employee ""felt warm, palpitations, flushing. Had high blood pressure (no history of). Was released, driven home by family member."" Systolic BP in 180s-190s, diastolic BP in 100s-120s. BP was monitored to progressively decrease to 140s/90s and employee was released to husband to be taken home. Was recommended that husband take employee to ER for further assessment if symptoms persist or if condition worsens. Employee was in no further distress and was released home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Feeling hot', 'Flushing', 'Hypertension', 'Palpitations']",1,MODERNA,IM 977618,,36.0,M,"Headache, Myalgia, CHILLS Narrative: EMPLOYEE REPORTS THAT HE WOKE UP 1/1/2021 WITH CHILLS, BODY ACHES, AND FATIGUE THAT RESOLVED WITHIN 24 HOURS. RECENTLY HAD COVID INFECTION.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pain']",1,MODERNA,IM 977625,,39.0,F,Dizziness & Headache Narrative: reported that day after the injection woke up with a massive headache and was dizzy. the dizziness lasted half of the day. spent the day in bed.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Dizziness', 'Headache']",1,MODERNA,IM 977779,,36.0,M,FATIGUE AND SORENESS AT IINJECTION SITE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Fatigue', 'Injection site pain']",UNK,MODERNA,IM 977783,,32.0,M,"SWOLLEN LYMPH NODES IN ARMPIT, MILD PAIN AND INFLAMMATION Narrative: PATIENT REPORTS SWOLLEN LYMPH NODES LOCATED IN THE ARMPUIT FOR ABOUT 2 DAYS, MILD PAIN AND INFLAMMATION",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Inflammation', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 977791,,49.0,M,"Headache, arthralgia, metallic taste Narrative: Patient previous covid dx: 3/19/2020; antibodies at least as of 10/22/2020 vaccine: 12/31/2020, the next day awaoke with sore arm and mild headache sx progressed over next 4 hours to severe headache and neck/bilat shoulder pain and profound malaise. Some migratory arthralgias, transient lower extremity pains, and a metallic taste. Reminiscent of covid for about 6 hours. Some relief with nsaids and apap. By 30 hours later, just tired and soreness at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Arthralgia', 'Dysgeusia', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Neck pain', 'Pain in extremity']",1,MODERNA,IM 977801,,32.0,F,"SkinRash, Rash, Reported itchiness and skin rash radiating to the rest of her body. Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Pruritus', 'Rash']",1,MODERNA,IM 977858,,52.0,F,"Headache, Myalgia, fatigue, sore throat, ear pain",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/04/2021,4.0,OTH,,,,,,"['Ear pain', 'Fatigue', 'Headache', 'Myalgia', 'Oropharyngeal pain']",1,MODERNA,IM 977970,,38.0,F,"Body tingling; arthralgia, fatigue, night sweats Narrative: Some body tingling for a couple of hours beginning approx 1 hour after administration. Following day: moderate deltoid pain/soreness, mild arthralgia and myalgia, fatigue, night sweats. By day 2 after injection all sx resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Myalgia', 'Night sweats', 'Pain in extremity', 'Paraesthesia']",1,MODERNA,IM 977977,,73.0,M,"Arthralgia, NauseaVomiting, chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Nausea', 'Vomiting']",1,MODERNA,IM 978181,,76.0,M,TENDERNESS AT INJECTIONS SITE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 930904,CA,40.0,M,Symptoms began on 1/2/21 Self isolating Start of symptoms similar to a cold with mild discombobulation Symptoms are mild with a loss of taste and smell continuing,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,01/02/2021,15.0,PVT,None,None,None,,None,"['Ageusia', 'Anosmia', 'Confusional state', 'Nasopharyngitis', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 930905,NJ,58.0,F,"Dizziness, kept patient in observation for 30 min.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,['Dizziness'],2,PFIZER\BIONTECH,IM 930906,AZ,52.0,F,"Thought I felt fine, but lightheaded, dizzy upon leaving clinic, waited in my car for a while drove home with adult daughter passenger, still felt lightheaded and dizzy. About an hour later headache, body aches. Injection site not bothersome. Came home, rested, still resting, still feel ?off? continuing mild symptoms at 10 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,WRK,"Metformin, zoloft, buspar, hydroxizine, trazadone, lithium,",,"Pcos, depression, anxiety",,Sulfa drugs,"['Dizziness', 'Feeling abnormal', 'Headache', 'Pain']",UNK,MODERNA,IM 930907,CO,23.0,F,"On 1/4/2020 at roughly 07:00 PM, a dull ache started in my right arm where the vaccine was injected, it radiated from my right shoulder, to my right shoulder blade. My arm felt very heavy. There was also a small hard lump beginning to form with a little heat at the injection site. I had difficulty sleeping due to the aching pain. On 1/5/2020, I woke up at 06:30 AM, the lump had grown in size, and was much more red and hot to the touch, in an oval shape. By roughly 11:30 AM same day, it began to itch, I had checked it and the lump had raised significantly. Hot to the touch. The dull ache had begun radiating into my right armpit as well as down to my right elbow. By 06:00 PM, same day, the aching had continued, the lump was still very raised, itchy, red, and hot. It looked like a large hive. By 06:30 AM on 1/6/2020, the dull ache had mostly subsided, my shoulder blade still felt uncomfortable. The itching continued. The redness spread in size, however the swelling of the lump had gone down slightly. By 06:30 AM on 1/7/2020, the lump had mostly gone down in size significantly, the dull ache had subsided completely, the redness had gone away. By 1/8/2020, 10:00 PM, the lump and swelling are gone, no ache, no itch, still a slight discoloration where lump was.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,PVT,"Paroxetine, 10mg. Norgestimate and Ethinyl Estradiol, 0.25 mg/0.035 mg, Omeprazole, 40 mg.",None,Obesity,,"Penicillin, Benadryl","['Erythema', 'Injection site mass', 'Injection site pain', 'Injection site warmth', 'Limb discomfort', 'Pain', 'Pruritus', 'Skin discolouration', 'Sleep disorder']",1,MODERNA,SYR 930908,TX,33.0,F,"Headache, muscleweakness,chills, swollen left limp notes",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,asa 81mg,N/a,N/a,,N/a,"['Chills', 'Headache', 'Lymphadenopathy', 'Muscular weakness']",1,MODERNA,SYR 930909,NJ,50.0,F,"Flushing, kept in Observation area for 30 minutes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,['Flushing'],2,PFIZER\BIONTECH,IM 930910,HI,52.0,F,Patient received COVID vaccination around 12:15pm. Patient was monitored for the appropriate amount of time by nursing staff. Patient passed away at 2:15pm.,Yes,01/08/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,SEN,Patient was refusing to take all medications for over a year,None,"Hemiplegia and hemiparesis following cerebral infarction affecting right dominant side, major depressive disorder, aphasia following cerebral infarction, muscle weakness, dysphagia, hypothyrodism, type 2 diabetes, hyperlipidemia, hypomagnesemia, hypokalemia, hypertension, gastro esophageal reflux disease, gastritis, constipation",,"Metformin, morphine, statins, latex",['Death'],1,MODERNA,IM 930911,NJ,43.0,F,Tingling in right arm that radiated up to cheek and eye,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,['Paraesthesia'],1,PFIZER\BIONTECH,IM 930912,NY,73.0,M,Diarrhea followed by death 24 hrs after vaccination,Yes,01/08/2001,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,UNK,None,None,None,,None,"['Death', 'Diarrhoea']",UNK,PFIZER\BIONTECH,UN 930913,NM,37.0,F,"Day 1: shoulder pain, headache, fatigue, and temp of 99 Day 2: severe nausea, fatigue, headache, and body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Keppra Lamotrigine Novalog,,Type 1 diabetes and epilepsy,,"Cipro, Levaquin, Sulfa, TB screen","['Arthralgia', 'Fatigue', 'Headache', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,SYR 930915,NJ,29.0,M,Broke out in mild hives on face a few hours after the shot.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,WRK,,,,,Ibuprofen,['Urticaria'],1,MODERNA,SYR 930916,NM,32.0,F,Patient is a 32 yo G2P1001 with EDD 5/2/2021 by 7w US. She had the first dose of the Pfizer Covid 19 vaccination on 12/17/2020 at the Health Clinic and the second dose on 1/7/2021 at 1115 am. She began having abdominal pain and vaginal bleeding at 315 sm on 1/8/2021 progressing to a previable (22w2d) preterm birth at 739pm on 1/8/2021.,Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,prenatal vitamin calcium supplement 1200 mg vitamin d3 1000 iu Aspirin 81 mg,none,none,,NKA,"['Abdominal pain', 'Exposure during pregnancy', 'Premature baby', 'Premature delivery', 'Vaginal haemorrhage']",2,PFIZER\BIONTECH,IM 930917,NJ,57.0,F,2hours post began with tingling in tip of tongue and bottom lip. Took otc benadryl.48hours later all right side of face became numb.Was sent for evaluation by employer to hospital.dx with adverse reaction.bells palsy I was given Decadron IM and medrol dose pack.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Metformin.prilosec.glyburide.januvia.vitimin B12.vitamin c.vitamin d claritin.,None,Niddm.svt..mitral valve prolapse..gerd.. hysterectomy Herniated disc lumbar,,Pepcid.textracyvline. doxycycline.vistaril. lima beans.aloe,"['Adverse reaction', ""Bell's palsy"", 'Hypoaesthesia', 'Paraesthesia oral']",2,PFIZER\BIONTECH,IM 930918,NM,62.0,M,Stomach has pains. Drank lots of water and got lots of walking at work. Symptoms slowly lessened throughout the day but still feeling them at 10:30 pm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/08/2021,3.0,UNK,3000 units vitamin D,None,None,,None,['Abdominal pain upper'],1,PFIZER\BIONTECH,IM 930919,NM,62.0,M,Stomach gas pains. Drank lots of water and got lots of did a lot ofwalking at work. Pain slowly subsided throughout the day but was still somewhat present at 11:00 pm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/08/2021,3.0,UNK,3000 IU vitamin D 3,None,None,,None,['Flatulence'],1,PFIZER\BIONTECH,IM 930920,CA,30.0,M,"Right after the injection I did not notice any symptoms, I sat for 15 minutes and felt fine. A few days later I noticed some red bumps on my stomach and back area only. The bumps seem to be staying the same, they do not itch and are not in any kind of specific pattern. I do not have any other major symptoms. The rash is not painful, not hot, and i do not believe it was due to anything else.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/05/2021,3.0,PVT,Take a daily vitamin and probiotic daily,I did have a sebaceous cyst that was drained at the end of November and completed a 10 day course of antibiotics doxycycline mono 100 mg tabl 2x daily,,,NKDA,['Rash erythematous'],1,PFIZER\BIONTECH,SYR 930921,WA,35.0,F,15 hours after immunization patient reported swelling of tongue. Gums and tongue felt raw. Swelling resolved ~36 hours after onset,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,"albuterol, cetirizine, esomeprazole, gluticasone inhaler, melatonin, montelukast, Armour thyroid,",,"Asthma, GERD, Hashimoto's thyroiditis, papillary thyroid cancer s/p thyroidectomy",,"doxycycline, sulfa antibiotics, tramadol, kiwi, mushrooms","['Gingival disorder', 'Glossitis', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 930922,CA,51.0,F,"Approximately 28 hours after receiving my first dose of the Moderna vaccine, I experienced intense pain and immobility in my left arm. I had soreness as one would expect after receiving the injection but this was different. I took ibuprofen and went to bed. I awoke several times in the night after rolling over in bed with pain. I awoke in the morning and could not move my arm. My husband had to assist me in dressing. That day (two days following vaccine), I had myalgia, neck pain, mild headache, fatigue, and a low grade fever. My arm continued to be very painful although no swelling or redness. The following morning (three days following vaccine), although I still had pain and decreased mobility, it was improved. I am filing this report on the evening of 1/8/2021. Although I am not back to baseline, I anticipate that I will be in the next few days. I thought it was important to report this given the severity of my symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,None,None,Celiac disease Rosacea Mild intermittent asthma; seasonal allergies,,Celiac disease - gluten intolerance,"['Fatigue', 'Headache', 'Injected limb mobility decreased', 'Loss of personal independence in daily activities', 'Myalgia', 'Neck pain', 'Pain in extremity', 'Pyrexia', 'Sleep disorder']",1,MODERNA, 930923,TN,39.0,F,10-12hrs after... 30min of aches and chills that subsided with Tylenol and nap 1 week later - current: redness at injection site that is spreading and slightly feverish on spot,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PUB,Zyrtec Elderberry Tri-Previfem,None,None,,NKA,"['Chills', 'Injection site erythema', 'Injection site warmth', 'Pain']",1,MODERNA,SYR 930924,,25.0,F,"Muscle soreness of the left arm (injection site arm) was reported a few hours after the vaccination. The soreness continued to get worse throughout the rest of the day after administration. The next day, muscle soreness was significantly reduced and by the end of the day (1/8/21) it was completely resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,,,,,,"['Injection site pain', 'Myalgia']",1,PFIZER\BIONTECH,IM 930925,WA,36.0,F,25 minutes after receiving vaccination ascending numbness of left half of tongue (ipsilateral to location of vaccination site) with associated moderate headache. No tongue swelling or weakness. No breathing difficulty. This was followed by left arm numbness and mild left leg numbness. Left-sided paresthesias /numbness resolved within 3 hours of vaccination. The severity was mild-moderate without there ever being complete loss of sensation. No vision problems or weakness.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,WRK,None,none,Cold Urticaria,,None,"['Headache', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia']",1,PFIZER\BIONTECH,SYR 930926,,24.0,F,muscle soreness in arm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PUB,Birth Control Pill,,,,,"['Myalgia', 'Pain in extremity']",UNK,PFIZER\BIONTECH,IM 930927,WA,36.0,F,"Approximately 10 minutes after injection I started driving home. I began to feel like my mind was foggy and some fatigue, then my lower lip and tongue started to tingle. I stopped driving and waited to see if anything further developed. I then felt flush and my hands became clammy. After maybe 2 minutes these symptoms resolved, I never had any trouble breathing so I continued home and did not seek any medical attention. The whole time frame was about 5 to 10 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Vitamin D Women's prenatal daily vitamin,None,None,,None,"['Cold sweat', 'Fatigue', 'Feeling abnormal', 'Flushing', 'Paraesthesia oral']",1,MODERNA,IM 930928,HI,34.0,F,"Within minutes after taking the vaccination I started to have a little bit of a heavy breathing heart beat racing high blood pressure sweating headaches, sensitive sight fever. Paramedics, doctors, National Guard, nurses, all came to try to help me and my blood pressure was raising high at about 160/100 or something like that, heartbeat was at 1:52 after an hour of vaccination throat started closing in itchy eyes and wheezing was rushed to Kaiser to get an antihistamine IV and famotidine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,"Allertec, losartan",None prior to vaccination.,HBP Asthma,,Shellfish Latex Peanuts,"['Condition aggravated', 'Dyspnoea', 'Eye pruritus', 'Headache', 'Heart rate increased', 'Hyperhidrosis', 'Hypertension', 'Photophobia', 'Sensitive skin', 'Throat tightness', 'Wheezing']",1,MODERNA,SYR 930929,NE,28.0,F,"Dizzy, lightheaded, vertigo, nausea, vision out of focus, unable to walk straight and have to stabilize myself on the wall. I have had 6 episodes lasting 3-24 hours. It has been over 2 weeks (since 12/26/2020 - now).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/26/2020,5.0,PVT,Trazodone and Wellbutrin XL,None,"Chronic headaches, depression, anxiety",,None,"['Dizziness', 'Gait inability', 'Laboratory test', 'Nausea', 'Vertigo', 'Vision blurred']",UNK,PFIZER\BIONTECH,IM 930930,WA,42.0,M,Moderna COVID-19 Vaccine EUA Nausea ongoing Vomiting 12 hours Diarrhea ongoing Gas ongoing Headache ongoing Fever 12 hours Chills 6 hours Injection site soreness 48 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,,,,,,"['Chills', 'Diarrhoea', 'Flatulence', 'Headache', 'Injection site pain', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 930931,CA,38.0,F,Left armpit swelling with pain and soreness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,Multivitamin,,,,,"['Lymphadenopathy', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 930932,CA,44.0,F,Fever 101.2 Chills Body aches Headache Losses of appetite,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,,None,None,,Macrobid latex,"['Chills', 'Decreased appetite', 'Headache', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 930933,CA,37.0,F,"While waiting the 15 minutes after the vaccine, I began to feel dizzy, I thought it was just because I was nervous. After the 15 minutes, I went outside and tood off my mask to get some fresh air. I went back to work and was still feeling dizzy. I drank water, ate some food and sat for a bit. At about 1pm, I was still feeling dizzy but also started feeling off, as if I were intoxicated or like how you feel when you just wake up from having anesthesia, sluggish. I then went home and slept for about 5 hours and now I feel much better. Will someone let me know if it is recommended I still get the second dose next month?",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,"Generic OTC Allery pill, OTC vitamins",None,None,,"Sulfa, blueberries","['Dizziness', 'Feeling abnormal', 'Nervousness', 'Sluggishness']",1,MODERNA,IM 930934,MN,47.0,F,"1/6/2021 day of vaccine pink, swollen injection site at bedtime. 1/7/2021 0200-Both eyes, lips and face very swollen with moderately swollen hands. Sore arm. 0815-Temp 99.9 scan. Swelling continued, coworker noticed my eyelids and under eyes swollen (rest of face was masked) 0845 1 gm tylenol and 600 mg ibuprofen. Drank lots of fluids. 1100 98.0 scan 1300 99.0 perspiring, malaise. Eyes still swollen, hands still swollen. Lips and cheeks normal. 1600 chills, fatigue. Drank lots of fluids. 1gm tylenol. Swelling of face resolved. 2000 went to bed early, tired, malaise. Hands mildly swollen. 1/8/2021 0815am 98.3 scan. No swelling. Moderate headache, malaise. Took 1 gm tylenol and 400mg ibuprofen. Noon- felt better, but very tired. 1600-arm mildly sore, no other symptoms. 2000- no return of symptoms 2345- no return of symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Levothyroxine Estradiol Propranolol Venlafaxine Chantix Prochlorperazine Atorvastatin Calcium/magnesium complex Glucosamine Chondroitin MSM,None,"Thyroid removal 12-2019 for metastatic thyroid cancer, Reactive lymph node hyperplasia tongue and tonsil 12-2019-unknown if I still have this, follow up will be 1-29-2021 for all above conditions.",,None,"['Chills', 'Eye swelling', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Injection site discolouration', 'Injection site swelling', 'Lip swelling', 'Malaise', 'Pain in extremity', 'Peripheral swelling', 'Swelling face']",1,MODERNA,IM 930935,CT,48.0,F,"Chills in early AM (around 2AM) but gone by 8AM, severe soreness in right arm (even hurts to type) unrelenting headache (since 2AM) that is unresponsive to 400mg Advil taken every 4 hours, very thirsty even though adequately hydrated, dizziness upon rising to standing position or sitting up from laying in bed, feeling like I have a ?foggy brain?",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Venlafaxine, Trintellix, Spironolactone, Advil, Advil PM",None,"No gall bladder, gastroparisis, bipolar disorder, hypoglycemia",,None,"['Chills', 'Dizziness postural', 'Feeling abnormal', 'Headache', 'Pain in extremity', 'Thirst']",1,MODERNA, 930936,TX,25.0,F,"Symptoms began with arm soreness with minor swelling around the administration area around 6-7 pm. Chills began at 11 pm lasting for half an hour followed by a fever of 102f. The fever continued during the night of 1/5/21 and early morning of 1/6/21. Woke with a strong headache in the morning at 7 am. Headache caused dizziness and some loss of balance when walking. Had minor facial swelling with minor numbness around mouth and neck. The fever, headache, and swelling continued throughout the day of 1/6/21. The fever broke around 7 pm on 1/6/21. Nyquil and ibuprofen were taken for fever and headache. During the morning of 1/7/21, the fever and facial swelling had ended. The headache continued during the morning of 1/7/21 until midday. By the evening of 1/7/21, all symptoms had ceased.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PHM,None were taken.,None,None,,NKA,"['Administration site swelling', 'Balance disorder', 'Chills', 'Dizziness', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Pain in extremity', 'Pyrexia', 'Swelling face']",1,MODERNA,IM 930937,MI,41.0,F,Itching palms ears head and eyes itching then escalated to itching all over and swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,"Lexapro, aleve, tylenol",none,none,,none,"['Pruritus', 'Swelling']",2,PFIZER\BIONTECH,IM 930938,CA,32.0,F,"Fever, chills, headache, joint pain, injection site soreness, nausea, vomiting, muscle pain and weakness, abdominal pain. Difficulty getting out of bed and poor oral intake. Took 3000 mg acetaminophen and 500mg naproxen. Lasted 5am-7pm on 01/08/2021 currently severe side effects subsided to minimal side effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,,,,Flu vaccine 2020,"Eggs, gluten, soy","['Abdominal pain', 'Arthralgia', 'Chills', 'Decreased appetite', 'Headache', 'Injection site pain', 'Mobility decreased', 'Muscular weakness', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 930939,CO,29.0,F,"Nausea, fever, chills, muscle pain, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PVT,Ibuprofen,Covid19,None.,,None.,"['Chills', 'Fatigue', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,SYR 930940,CA,31.0,F,"Redness, tenderness, pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,None,None,None,,None,"['Erythema', 'Pain', 'Tenderness']",1,MODERNA,IM 930941,CT,45.0,F,"Elevated temp 102.3, near syncope x4, chills, joint pain especially in back and neck, nausea 12 hours, pulse 100, night sweats, dizziness and slight headache after Tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"Nifedipene 90mg er, meloxican 15mg, multivitamin, turmeric supplement, apple cider vinegar supplement, zinc, vitamin d3, vitamin b12, probiotics, vitamin a, primrose",,Lupus/althralgia,,"Allergic to erythromycin, tree nuts and latex","['Arthralgia', 'Back pain', 'Body temperature increased', 'Chills', 'Dizziness', 'Headache', 'Nausea', 'Neck pain', 'Night sweats', 'Presyncope']",2,PFIZER\BIONTECH,IM 930942,SC,46.0,M,"Development of hives at about 35 to 36 hours. Hives on the trunk, arms, and extremities. No facial or head involvement. Awoken from sleep with diffuse hives around 1:30 am on 1/9/21 after experiencing mild hives about 4 hours earlier. Took 37.5 of Benadryl, 1000 mg of Tylenol, 40 mg Pepcid, 20 mg of Zyrtec, and 40 mg of Prednisone. Hives eased. Around 2:15 am.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,"Norvasc 5 mg , Tylenol and Motrin",None,HTM,,PCN,['Urticaria'],2,PFIZER\BIONTECH,IM 930943,NE,43.0,F,"Sore arm, warm to touch, redness and itching in a 4 in diameter of the injection site. Also a smaller 1/2in-1in circle developed just to the side of the 4 in red circle. No treatment, redness went away after 5-7 days. Doctor believes a local reaction to the vaccine at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/31/2020,7.0,PVT,,none,none,,Ampicillin,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site warmth', 'Local reaction']",1,MODERNA,IM 930944,NV,46.0,F,"Localized swelling, tenderness, welting and warm to the touch on left deltoid area. Large raised area over almost half of the upper arm in injection site. Noticed three days ago and it has waxed and waned slightly in this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,"Atorvastatin, Blisovi Fe, Singulair, Rabeprazole, iron, multivitamin, azelastine, fluticasone, claritin, vitamin D3, compounded oral immunotherapy drops.",None.,"Environmental allergies, hyperlipidemia.",,Tramadol. Topical Camphor.,"['Injection site pain', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Urticaria']",1,MODERNA,IM 930945,IL,43.0,F,"Generalized edema, shortness of breath, change in taste",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/04/2021,12.0,WRK,Zoloft Effexor Nexium Zyrtec Vit D Occuvite,,Seasonal allergies Depression GERD,,Seasonal,"['Brain natriuretic peptide increased', 'Dyspnoea', 'Fibrin D dimer increased', 'Generalised oedema', 'Taste disorder', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 930947,NY,41.0,F,"About 5-10 minutes after receiving the vaccine experienced spontaneously elevated heart rate and lightheartedness while sitting in a chair in the observation room. After a few minutes pulse returned to normal and lightheartedness abated. At no point did I experience shortness of breath, no facial or airway edema. Just a brief period of tachycardia and feeling of impending doom.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Multivitamin Vit C Vit D3,Mild cold preceding week,None,,Sulfa abx,"['Dizziness', 'Dyspnoea', 'Feeling of despair', 'Heart rate increased', 'Immediate post-injection reaction', 'Tachycardia']",1,PFIZER\BIONTECH,IM 930948,OH,34.0,F,Large welted painful rash to vaccination site/ upper arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/08/2021,4.0,WRK,None,None,None,,None,"['Injection site rash', 'Rash', 'Urticaria']",UNK,MODERNA, 930950,MT,58.0,F,"Bad headache, dizzy, blurred vision, nausea, very tired. vomiting.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,SEN,"Losartan HCTZ, vitamins",none,"HBP, obesity",influenza vaccine,penicillian,"['Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Vision blurred', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 930951,NH,28.0,F,"Within the hour of the symptoms (noticed around 5:15pm) I started to have a rash on the left side of my neck, along with small red dots on my chest. My throat was tingling ajd I had what is best described as ?on and off? rushes throughout my body. I returned back to the site where I got my test from and reported my reaction somewhere around 5:30. I was given 50 mg of Benadryl and told to have friends come and pick me up and drive me home. Around 8pm I was having slight tingling in my throat however it was mentioned it could be the after effect of the sensitivity to the vaccine. I was advised to not have the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,N/A Stopped taking my SSRIs due to increase anxiety.,Not at the time of vaccination. Two weeks prior didn?t feel the best and had sore throat so had to quarantine due to sore throat symptom. Tested negative for covid. Returned to work 01/08.,,,Wellbutrin- hives Latex- mild,"['Adrenal disorder', 'Pharyngeal paraesthesia', 'Rash']",1,MODERNA,SYR 930952,CA,41.0,F,injection site soreness; neck pain and left shoulder pain,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/06/2021,2.0,PVT,,,,,,"['Injection site pain', 'Neck pain']",1,MODERNA,IM 930953,IN,0.42,F,"Ichy rash on trunk of body and derriere crack, also under arm pits, and neck, so far. Have had for 3 days now and still driving me nuts with the itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,PVT,"Viberzi, Creon, Citalpram, Gabapentin, Tramadol, Montelkcast, Duloxetine, Prevagen, Vitamin D3 , Centrum Silver, Mucinex, Cholestyramine.",,COPD,,"Zyban, Sulfa,","['Rash', 'Rash pruritic']",2,MODERNA,IM 930954,NC,33.0,F,"Redness, swelling, pain 1 week after vaccine given.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PUB,Merhimazole 5mg,None,"Asthma, hyperthyroid",,"Peanuts, gluten, milk, rice, dust, pollen","['Erythema', 'Pain', 'Swelling']",1,MODERNA,IM 930955,CA,31.0,F,"On 1/1/2021 I developed a large, red, itchy, hot area approximately 3 inches by 5 inches on my left deltoid area, over the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/01/2021,8.0,OTH,"Lexapro, Wellbutrin, Gabapentin, Labetalol, Birth control pills",None,"OCD, Anxiety, sciatica, hypertension, obesity",,Vicodin - rash,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 930957,CT,23.0,M,"Small amount of hives, took an allergy relief and symptoms went away. Hives came back, took Benadryl and symptoms went away. Repeat process for 4-5 days. On 5th night, increase in amount of hives, all over back and face, took Benadryl and eventually went away. Went to walk-in, provider recommended Claritin and Pepcid daily. I've taken those for three days now with the occasional Benadryl and haven't noticed any hives. Hives varied in size and location. Ultimately in all different areas of my body at one point of another. I have pictures if needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/31/2020,2.0,PVT,none,none,none,,NKA,['Urticaria'],1,MODERNA,IM 930958,,34.0,F,"Chills, low grade fever up to 100.00, loss of smell, loss of taste, fatigue, body aches, insomnia, injection site pain and soreness, dehydration. Remedy with rest, electrolytes, fluids, ibuprofen. Most symptoms lasted 24 hours, however total loss of smell and taste was 48 hours and is now selective at 72 hours. Have full sensation of taste (can recognize bitter/sweet/etc) but can only taste sweet/bitter. iE can taste coffee with or without sweetener but cannot taste food such as pizza or french fries.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,MIL,"sertraline 75mg daily, cetirizine 10mg daily, montelukast, Flonase",None known,"migraines, spinal injuries",,Percocet - hives in mouth and throat,"['Ageusia', 'Anosmia', 'Chills', 'Dehydration', 'Dysgeusia', 'Fatigue', 'Injection site pain', 'Insomnia', 'Pain', 'Pyrexia']",1,MODERNA,SYR 930959,NJ,55.0,F,"Headache started 12/30/2020. Nauseous and dizzy off and on. Arm pain at injection site for 3 days. Headache unresolved even after taking headache med, ibuprofen, oxycodone. Nausea and dizziness is intermittent.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"Ranexa, Indur, potassium chloride, torsemide, Lipitor, Singular, Vit B12,vitamin D, claritin, Celebrex, lyrics, pro tonix, aspirin, bystolic,spironolactone, oxycodone",None,"Asthma, hypertension, hypokalemia, heart disease, IBD,herniated disc",,None,"['Dizziness', 'Headache', 'Injection site pain', 'Nausea', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 930960,WI,43.0,F,"Body aches, chills, slight headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,WRK,"Examestane, Zyrtec, calcium/bit D, multivitamin, ibuprofen",No,No,,No,"['Chills', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 930961,TX,33.0,F,"Day 1: Chills, severe pain in injection site arm including muscular and joint pain. Pain down entire arm radiating up neck. Day 2: fatigue, dizzy, lightheaded Day 3: vomiting Day 4: vomiting and severe headaches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Bupropion, buspirone, trintellix, stool softener, loratidine, fiber gummy?s",None,"Anxiety, depression, IBS-c",,None,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Injection site joint pain', 'Injection site pain', 'Neck pain', 'Pain', 'SARS-CoV-2 test', 'Vomiting']",1,PFIZER\BIONTECH,SYR 930962,IL,44.0,F,Woke at 4am with chills. Temperature 101.1F temporal. Otherwise feeling ok. Just drinking fluids.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,None,None,None,,None,"['Body temperature increased', 'Chills']",2,PFIZER\BIONTECH,IM 930963,,45.0,F,"Reactions: arm pain, arm swelling, fever low grade, fatigue, myalgias, arthralgias. lasted till 6 pm 1/05/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,,,,,,"['Arthralgia', 'Fatigue', 'Myalgia', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 930964,UT,29.0,F,"Critical level INR (5.6) without cause after stable anti coagulation therapy and no additional changes in diet, disease, etc.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/08/2021,3.0,PVT,"Lexapro, busperone, coumadin",None at time of vaccination,"Antiphospholipid syndrome, celiac disease",,"Penicillin, amoxicillin, clindamycin, bactrim, keflex","['Anticoagulant therapy', 'International normalised ratio increased']",1,MODERNA,IM 930965,SC,33.0,M,Rigors for ~45 min,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Tylenol,None,None,,None,['Chills'],2,PFIZER\BIONTECH,SC 930967,AZ,50.0,M,Left sided facial numbness 36 hours Dizzy spells 36 hours Fatigue 58 hours and counting body aches 48 hours headache 36 hours stabbing pain 36 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,OTH,Lisinopril HCTZ Albuterol inhaler Zyrtec Chlorpheneramine Vitamin B Complex,none,Hypertension Asthma,,NKA,"['Dizziness', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Pain']",1,PFIZER\BIONTECH,IM 930968,KS,56.0,F,"That night had numbness to both arms only from elbows down was very cold , both hands cold but no fever. Next day more achy fatigue, in general felt worse. Throughout that day and next day had fevers up 102 chills, sweats and horrible headaches site from injection red swollen warm to touch. Headaches were very debilitating, took 600mg ibuprofen at least 6 hours apart . On a side note I was positive for Covid on 11/02/2020. And this was exactly how I felt then except I also had the covid pneumonia .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/09/2021,3.0,PVT,"Wixela. Albuterol,",None,Asthma,,Lortab,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Hypoaesthesia', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Malaise', 'Pain', 'Peripheral coldness', 'Pyrexia']",UNK,MODERNA,SYR 930969,CA,25.0,F,"Myalgias, fever, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,Fluoxetine,,,,,"['Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH, 930970,,42.0,F,"Headache - severe/migraine type, lasted 3 hours, then headache for 1.5 days moderate",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,MIL,Immune suppressing medication,None,"2 immune conditions, HBP,",,,"['Headache', 'Migraine']",1,MODERNA,SYR 930972,VA,34.0,F,"Fever in the evening of 101.8, following morning fever 101.8. Jan 7th evening fever 100.8. Tylenol taken.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,,,,,,['Pyrexia'],2,PFIZER\BIONTECH,IM 930973,FL,67.0,F,Headache fever 100.7 Chills Diarrhea Joint pain Pain on site of vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,UNK,Creator10 mg,None,None,Shingles,Penicillin morphine,"['Arthralgia', 'Chills', 'Diarrhoea', 'Headache', 'Injection site pain', 'Pyrexia']",1,MODERNA, 930974,MD,51.0,F,Hypotension 90/60 experienced; Dizziness; almost passed out; rapid heart beat and unable to breath,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,Zoloft Execedrin,None,Depression,,None,"['Dizziness', 'Dyspnoea', 'Heart rate increased', 'Hypotension', 'Presyncope']",1,PFIZER\BIONTECH,SYR 930975,CA,37.0,F,"5:00 pm my left arm became very sore to raise or move. It felt like some had punched my shoulder and it was dead weight, my left armpit was also very sore even to touch. I took Tylenol 500mg 2 tabs po at 9 pm due to the pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,OTH,Sertraline HCL 50mg 1 tab a day,Low Hemoglobin,,,"PCN, Beans and food preservatives.","['Axillary pain', 'Injected limb mobility decreased', 'Limb discomfort', 'Pain in extremity', 'Tenderness']",1,MODERNA,IM 930976,KS,41.0,F,"Nausea, chills, fatigue for 12 hours. Treated with Advil at home, resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Birth control,None,Endometriosis,,Reglan and lavender,"['Chills', 'Fatigue', 'Nausea']",2,PFIZER\BIONTECH,SYR 930977,TX,42.0,M,"No reaction to first dose 12/16. I turned positive and recovered on 12/28 with only mild symptoms and received my second dose on 1/08. About 12 hours after started having rapidly evolving myalgia, high fever ( 104f) HR: 105 ( my baseline is 50-60) and RR 22 with SPO2 of 98-100%.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,,Recovering from SARS CoVID 19 test positive on 12/28/2020,None,,NKDA,"['COVID-19', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 930979,VA,54.0,F,On 01/01/21 the whole shoulder showed erythema from the acromion area to the neckline down to the chest area. Itching and redness developed late on 01/07/21 around injection site continues to grow into hardening red patch of about 5 inches wide today.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/07/2021,10.0,PUB,"Prescription : Levothyroxine 25mcg alternating with Levothyroxine 50mcg once daily Glucosamine/Chondroitin Triple Strength, Citracal, Mini Fish Oil, Vitamin D3 2000U, Folic Acid 400mcg and Nature Made Hair-Skin-Nail vitamin alternating wit",None,Hypothyroidism,,NKDA,"['Erythema', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'SARS-CoV-2 test negative']",1,MODERNA,IM 930980,NY,42.0,F,"gave her Tylenol after the shot but low grade fever started about 12 hrs after the shot. then the fever spiked to 102.6 about 6 hrs. later. gave her Tylenol and fever stayed high. as she is non verbal, she could not tell us how she felt, but we observed her to be lethargic. she kept putting her hand on her forehead indicating headache. 24 hours after shot low grade fever remained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"levothyroxin, metformin, meloxicam, vitamin B 12, vitamin D , multivitamin",none,"patient has a developmental disability , neurological impairments, poly cystic ovarian syndrome, under active thyroid, low B 12, low iron",,"Penicillin, Clyndomycin, iv morphine, darvocet","['Headache', 'Lethargy', 'Pyrexia']",1,MODERNA,IM 930982,FL,61.0,M,"The day after the vaccine, I felt a bit fatigued. Then for 2 days, I felt fine. Then starting on the 3rd day until present, I feel extremely light-headed and unsteady with a persistent severe headache. Almost feels like there is pressure in my head for lack of a better description. I feel feverish as well but do not have a fever. I have difficulty maintaining balance on my feet so it is difficult to walk. I did seek medical attention yet since I live alone and do not feel comfortable to drive. Although the symptoms are difficult, I also don't consider them an emergency to warrant calling an ambulance.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,WRK,Pradaxa 150MG 2x day Losartan-HCTZ 100-25MG Duloxetine HCL DR ? 60MG Topiramate ? 100MG,None,History of DVT,,Penicillin,"['Balance disorder', 'Dizziness', 'Fatigue', 'Head discomfort', 'Headache', 'Impaired driving ability', 'Pyrexia']",1,PFIZER\BIONTECH,IM 930983,NV,32.0,F,Unknown if it?s is related or not. Terrible nausea which turned into vomiting and diarrhea for 8-12 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/08/2021,3.0,PVT,Prenatal vitamin,None,None,,None,"['Diarrhoea', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 930984,ME,57.0,M,"55 y/o male with hx of anaphylaxis due to peanut allergy. Guardian pharmacist noted the change in facial color and alerted RN who was monitoring s/p vaccination of her observations. He was red with facial edema upon my arrival. Benadryl 25mg PO while he was still able to swallow by RN. EMS called while he took the Benadryl. After Benadryl, checked vitals ? VERY hypertensive and increasing diaphoresis; Started to wax and wane with consciousness. Administered epi pen by RN in attendance once change in level of consciousness was noted. After epi, became pale, increasing diaphoresis with change in level of consciousness. BP was lower, still hypertensive. Placed on floor by staff. While on the floor, consciousness improved. EMS arrived and assumed care.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,Not known - reviewed at pre vaccine evaluation / assessment,none notes,peanut allergy,,peanuts,"['Blood pressure measurement', 'Delirium', 'Erythema', 'Hyperhidrosis', 'Hypertension', 'Pallor', 'Skin discolouration', 'Swelling face']",1,MODERNA,IM 930986,TX,71.0,M,"Developed a hard rather large welt red swollen bump 4"" below left breast nipple and an additional smaller one 1"" to the right and redness trailing downward and to the sides. I was in the 15 minute waiting area they send you to after you receive the shot. I first noticed an itching and then felt the welt under my shirt, stuck my hand in my shirt and felt the welt developing. Concerned, I approached the two paramedics there and they looked at it and said it looked like a bug bite but I am pretty sure it is not a bug bite and that is related to the vaccine. It's two days later and the welt is still there although smaller but still hard and still itching and sensitive to the touch but the redness that was extending outward is gone and now it consists of the main bump and the smaller one only. The smaller one looks like a big pimple and the large one is about 1/2 "" in diameter with redness around that. When researching on the internet I stumbled on this site and thought I needed to report it and am still wondering if it is anything serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,prednisone 10 mg every two days Meloxicam 15mg per day,,,,penicillin,"['Breast swelling', 'Erythema', 'Induration', 'Pain of skin', 'Pruritus', 'Urticaria']",1,MODERNA,IM 930987,NY,37.0,M,Headache and body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Vitamins,No,No,,No,"['Headache', 'Pain']",1,PFIZER\BIONTECH,IM 930988,ME,39.0,F,abroximately 10 min post vaccination patient reported feeling odd and skin turning red. Skin botchey. still speaking and communicating with staff on site. Benadryl 25mg given po which did not relieve symptoms . EMS called. As ss continued patient was laid on the floor and offered epipen. initially refused but did accept once EMS arrived and encoutraged her to do so. Administed by RN on site and transported to hospital ER by EMS,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,,"noted to be working with primary care and oncolgy regarding some ""issues"". Noted in discussion with pre- vaccination pharmacist that she had discussed risk vs benefit of vaccination with onclology and encouraged to receive vaccine.",see above,,"several known allergies noted. Patient reported ""tree nut allergy "" as well as other sensitivites","['Feeling abnormal', 'Rash macular']",1,MODERNA,IM 930989,MD,26.0,F,"0530 - woke up. nausea, dizziness, malaise, generalized significant joint and muscle pain. Unable to stand. 0535 - crawled to Bathroom in case of vomiting, tried to stand and had near LOC (vision completely black, only able to hear), dizziness, nausea, tingling and loss of function of hands/feet acc. by extremities twitching, hyperventilating, cold sweat. 0555 - husband helped me downstairs with plan to go to ER, but I refused and wanted to sit down. violent body shakes, nausea, hyperventilating, chills, dizziness. Ear temp 98.8. Was covered in blankets and drank ~8oz water. 0630 - body shakes stopped. mild waves of nausea/generalized malaise and muscle pain/lightheadedness continued. 0730 - same symptoms, ear temp 100.1. Removed some blankets 0800 - ear temp 99.8, chills, lightheadedness, mild headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PUB,Paragard IUD,,,,PCN,"['Arthralgia', 'Blindness', 'Body temperature increased', 'Chills', 'Dizziness', 'Dysstasia', 'Fine motor skill dysfunction', 'Headache', 'Hyperventilation', 'Malaise', 'Muscle twitching', 'Musculoskeletal disorder', 'Myalgia', 'Nausea', 'Paraesthesia', 'Presyncope']",1,MODERNA,IM 930990,FL,47.0,F,15 minutes post vaccine felt like her heart was racing/working harder then developed chills. BP 144/88 P-67 PO 100% R/A,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PVT,Unknown,Unknown,Unknown,,Codeine,"['Chills', 'Palpitations']",UNK,MODERNA,SYR 930991,IL,25.0,F,"dizzy, nausea, high heart rate, sore arm, fatigue. symptoms lasted about 4 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,MIL,"Adderall, received anthrax and typhoid vaccine 9 days prior to COVID vaccine",,,,avacados,"['Dizziness', 'Fatigue', 'Heart rate increased', 'Nausea', 'Pain in extremity']",1,MODERNA,SYR 930992,VA,44.0,M,INCREASE IN TEMPERATURE 2HR AFTER VACCINE ADMINISTERED. TEMP 100F AS OF 1100. PT WAS ADVISED TO GO TO ER IF SYMPTOMS WORSEN OR PERSIST. PT DIRECTED TO CALL CLINIC IN THE MORNING WITH AN UPDATE,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,MIL,,NO,NO,,Lipitor/PNC,['Body temperature increased'],1,PFIZER\BIONTECH,IM 930993,IL,27.0,F,"Nausea, vomiting, diarrhea, fever, chills, dizziness, headache, muscle and joint aches, pain at the injection site, dry mouth, shortness of breath. Took ibuprofen and Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"Junel birth control, Zyrtec 10mg, benadryl 50mg, ibuprofen 400mg",None,None,,None,"['Arthralgia', 'Chills', 'Diarrhoea', 'Dizziness', 'Dry mouth', 'Dyspnoea', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 930994,ME,37.0,F,aprox 10 minues post vaccination. Patent exspessed that she was itchy and in distress. she was asked to remove her mask and some redness in face as well as swollen mouth / lips noted. Bendryl 25mg given. EMS called and Patient evaluated by RN on site. Patient began to have chills causing severe shivering. Covered with walrm blankts and placed on the floor. Epi pen adminsited by pharmacist on site at the clinic. Patient began to feel better prior to tranfer to ER by EMS Remained concious durring even,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,,,,,,"['Chills', 'Erythema', 'Feeling abnormal', 'Lip swelling', 'Mouth swelling', 'Pruritus']",2,MODERNA,IM 930995,NH,60.0,F,"17 hours after vaccine, developed gradually worsening fatigue, myalgias, arthralgias, chills, sweats, malaise, and fever up to 103. Sxs peaked at approx 24 hrs post vaccine administration, resolving nearly completely by the following morning. Would have reported via v-safe but had no info to access the app.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,,,Osteoporosis,,"Codeine, sulfa","['Arthralgia', 'Chills', 'Fatigue', 'Hyperhidrosis', 'Malaise', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 930996,NJ,45.0,F,"9 days after injection, started getting a rash which got bigger for the next couple of days. Also, I started getting dizzy. Delayed allergic reaction. Not sure I should take second injection . Started taking Benadryl and putting hydrocortisone on itchy rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,01/05/2021,9.0,WRK,"Probiotics, Allegra, glucosamine, multivitamin",No,Had vertigo a long time ago but not recently,,Sulfa Antibiotics,"['Dizziness', 'Hypersensitivity', 'Rash', 'Rash pruritic']",1,MODERNA,SYR 930997,TX,46.0,F,"Had severe chills at around 11pm on 11/07/2021, had to put on long pjs and 3 blankets. Woke up at 0530 with a severe headache & a temperature of 101.6. I had body aches and was extremely tired. I slept all day. I had a little cough with phlegm. I still had the chills & had to stay cornered up. I took some Tylenol through out the day and slept most of the day. My fever broke early at about 8am. The body aches and headache were all day. At about 1200a on 01/09/2021 my headache & body aches were feeling better, chills were gone. I woke up at 0630 on 01/09/221 with a temp of 99.5, still have a light headache, little body aches. I?m feeling much better on 01/09/2021 at 0726.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Tylenol, omega 3, multivitamin, joint support vitamin, magnesium",None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Hypersomnia', 'Pain', 'Productive cough', 'Pyrexia']",1,MODERNA,IM 930998,MD,25.0,M,"Became pale and lightheaded. Vision faded to almost completely black, but was remedied by lying down. After lying down I heard a static/white noise sound in my ears that progressively got louder. It hit a peak volume then slowly started to get quieter until it went away. Muscle soreness in injected arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,MIL,None,None,Fiberous Strand on Aortic Valve since I was 15. No issues have stemmed from it as far as I know.,,Clauvic Acid and Sawdust.,"['Dizziness', 'Myalgia', 'Pallor', 'Tinnitus', 'Visual impairment']",1,MODERNA,IM 931000,WI,33.0,M,"No fever, but chills, mild headache, fatigue and generalized malaise with myalgia, mild joint pain. Managed with Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,UNK,,,,Arm pain at injection site,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Malaise', 'Myalgia']",2,PFIZER\BIONTECH,SYR 931001,SC,33.0,F,"Day 11 post vaccine (1/8/2021) a large red, swollen, itchy circular area showed around vaccine injection site. Larger than a quarter but smaller than a softball size. Benadryl and hydrocortisone needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/08/2021,11.0,WRK,Multivitamin,,Hx of asthma,,"Amoxicillin, Ceclor, Sentra, erythromycin","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,PFIZER\BIONTECH,IM 931002,NM,45.0,F,"Swollen tender lymphnodes l. Supraclavicular, L. Axillary, L. Cervical 1 day after 2nd vaccine. Headache, chills, sore thrat, nasal congestion started mostly day after, headache day of both tbe first and second vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Celexa,None,None,,None,"['Chills', 'Headache', 'Lymph node pain', 'Lymphadenopathy', 'Nasal congestion', 'Oropharyngeal pain']",UNK,PFIZER\BIONTECH, 931003,TN,44.0,F,"Headache, chills, joint and muscle pain, fever of 102, nausea, lymphadenopathy Lt Axilla.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/06/2021,5.0,PVT,Birth control mini pill Ibuprofen,None,Migraines,,Oxycodone,"['Arthralgia', 'Chills', 'Headache', 'Lymphadenopathy', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 931004,CT,48.0,F,"Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse sweating. Within 30 minutes heart rate increased and a little clearing of throat. A little over an hour nausea started and increased clearing of throat , slight feel of constricture in throat and a slight feeling of heaviness in chest, and jittery and heart rate still feels increased. Nurse at Nursing home watched for 45minutes until I chose to leave. In my vehicle and home is when nausea started. Phone call contacts with nursing home staff continued for an hour. I took 2 benadryl and 2 Tylenol, napped. Felt better. Nausea 3 days. Tired and neck lymph achy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,SEN,"Qd meds:Multivitamin, vitamin C, D, Biotin, Zyrtec, pantoprazole. PRN meds: butalbital apap caffeine tabs, excedrin, advil, meclizine, benadryl.",None,"Yearly bronchitis, yearly sinus infections, cold urticaria, osteoarthritis left hip and neck, hormonal migraines.",H1n1 vaccine,"Allergies to animals, cold urticaria, dental nitric oxide, doxycycline, gabapentin, nortriptyline, topiramate, ciprofloxacin, prednisone.","['Chest discomfort', 'Erythema', 'Fatigue', 'Feeling jittery', 'Flushing', 'Heart rate increased', 'Hyperhidrosis', 'Lymph node pain', 'Nausea', 'Throat irritation', 'Throat tightness']",1,PFIZER\BIONTECH,IM 931005,NC,49.0,M,"Pain and swelling to injection site plus vertigo with Heachache. Motrin, Tylenol and Meclizine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,WRK,"Atenolol, Atrovastatin, Glipizide, HCTZ, Lisinopril, Metformin, Pioglitazone, Potassium, Duloxetine,",None,"PTSD, HTN, Diabetes 2",,"Latex, Morphine","['Headache', 'Injection site pain', 'Injection site swelling', 'Vertigo']",1,MODERNA,IM 931006,IL,59.0,F,"First vaccine injection 12/19/2020. Symptom of fatigue. Second vaccine injection 01/07/2021: About 3 hours after receiving the 2nd injection, I had terrible headache requiring dosages of OTC Tylenol, terrible abdominal pain/pressure similar to menstral cramping, extreme fatigue requiring prolonged sleep, nightmares (which I never have). All symptoms lasted for approximately 38 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Ezetimibe (10mg daily) Low dose aspirin (81mg daily to prevent blood clots) Biotin (OTC 5000 mcg daily) Nutrafol Womens Vitamins (OTC 4 tablets daily) Calcium (OTC 1200mg plus D3 5,000IU daily)",None,None,,Seafood,"['Abdominal pain', 'Discomfort', 'Fatigue', 'Headache', 'Nightmare']",2,PFIZER\BIONTECH, 931007,MI,41.0,M,"Malaise, fatigue, intense chills, shivering, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,none,none,,None,"['Chills', 'Fatigue', 'Headache', 'Malaise']",2,PFIZER\BIONTECH,IM 931008,OH,32.0,F,Blanchable rash at injection site 1?x 1.5? - the next day circular rash 2?x2? and painful/swollen lymph node in armpit of same arm as injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/08/2021,10.0,PVT,None,None,None,,None,"['Injection site rash', 'Lymph node pain', 'Lymphadenopathy', 'Pallor']",1,MODERNA,IM 931009,NC,60.0,F,"day 1-2 minor soreness. around day 7-8 injection site began to get itchy. day 10 itchy, red circle and somewhat warm to touch around injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,PVT,none,no,osteoporosis,,"bee/wasp stings, ants, bug bites","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 931010,SC,57.0,F,Within 15 minutes of vaccine being administered I developed itching then hives on my head which progressed to my upper lip. Took 25 mg benedryl capsule at approximately 25 minutes after vaccine administered. Waited 1 hour at vaccine site to ensure benedryl had been effective at slowing progression of reaction. Hives remained for several hours but no rash or other reaction noted. Also had a large broad hive Penny size at the injection site that still remains 19 hours after vaccine injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,None,None,"Asthma, severe allergies",,"Food esp nuts, bananas, oranges, shellfish, animals, latex, mold, trees, plants","['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 931011,MA,40.0,F,I had a rash on the back of my leg and significant pain around the rash.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,WRK,,,,,Sulfa drugs and selflabornes.,['Rash'],1,PFIZER\BIONTECH,IM 931012,MI,48.0,F,"fever chills body aches, massive headache and nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,no,no,no,,"norco, morphine, ultram","['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931013,NY,68.0,F,"Swelling of axillary area, very pain darking tissue in the rt arm where the infection was given in my rt deltoid.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PUB,protonix,none,low back pain,,none,"['Injection site pain', 'Skin discolouration', 'Swelling']",1,MODERNA,IM 931014,OK,21.0,F,"Fever 102.4F (O). Pain and swelling left upper arm. No erythema, no injection site fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,MIL,None,None,None,,NKA,"['Injection site pain', 'Injection site swelling', 'Pyrexia']",1,MODERNA,IM 931015,IL,23.0,F,All-over body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PVT,"Lamictal, Cetrizine, Larissia",,Depression,,Tree nuts,['Pain'],2,PFIZER\BIONTECH,IM 931016,GA,22.0,F,"Chills, fatigue, myalgias, sinus pressure, sharp lower back pain with radiation to knees, left TMJ pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,MIL,Avian,None,None,,None,"['Arthralgia', 'Back pain', 'Chills', 'Fatigue', 'Myalgia', 'Pain', 'Pain in jaw', 'Paranasal sinus discomfort']",1,MODERNA,IM 931017,MN,32.0,F,"Body- Massive body ache, body chills, headache and slight fever Arm- Tender to touch, warm and Pain at injection site. All of this happens the second day after the vaccination took place.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,SEN,No other medication or vaccinations was taken at the that time.,I was Covid-19 positive on Dec 10.,No chronic or long standing health conditions.,,No known allergies to medication or food or other products.,"['Chills', 'Headache', 'Injection site pain', 'Injection site warmth', 'Pain', 'Pain of skin', 'Pyrexia']",1,MODERNA,IM 931018,OH,44.0,F,"Fever 102F, chills, body aches, fatigue, injection site soreness/pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,none,"Covid-19 , mild",none,,none,"['Chills', 'Fatigue', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 931019,WI,47.0,F,"1 of 2, Pfizer-BioNTech COVID-19 Vaccine EUA received 1/7/21. Got hot flashes/sweaty, headache, left chest/breast pain, fatigue, stuffy nose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"tapazole, multivitamin, vitamin d3",,"multinodular goiter, congenital bicuspid valve, pvc's",,penicillin,"['Breast pain', 'Chest pain', 'Fatigue', 'Headache', 'Hot flush', 'Hyperhidrosis', 'Nasal congestion']",1,PFIZER\BIONTECH,IM 931020,NY,57.0,M,"Moderna COVID?19 Vaccine EUA Got vaccine 4pm. I ate dinner at 6pm. At 8pm felt slightly nauseous. By 9pm it was worse. By 9 30pm I was nauseous and full blow stomach pain. My stomach was 'roiling or churning.' Then between 9 30pm and 2 30am the next day I was nauseous, had stomach pain, I felt hot and cold and my head became more congested and I got a headache. Note: the head congestion was there prior to getting the vaccine, but it got worse. I sipped water throughout and it felt like I had to vomit (but I did not vomit). I took my temperature a few times it ranged from 98 to 98.8. My normal temperature is 97 to 97.5. By morning, or about 4am the worse symptoms were gone. My stomach felt more or less ok and at 7am I ate a light breakfast without incident. My temperature seemed to be elevated through the day. I felt somewhat weak during the day. Worst effects seem gone by Jan 8 evening. The only effect left is pain in my left upper arm. I consider these to be significant and worrying side effects and I may not take the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Daily. Valacyclovir hcl 1 gram daily and Phenylephrine HCI tabs 10mg, fish oil, curcumin 5000 mg, creatine monohydrate caps 1600 mg . vitamin D, and a few other minor supplements","None, except Herpes type 2 and allergies. I take Valacyclovir daily and Phenylephrine HCI daily","Herpes type 2 and sinus congestion that, I am told , is related to mold allergy.",,I have been told I am allergic to mold. I have trouble with nasal congestion as a long term problem,"['Abdominal pain upper', 'Feeling of body temperature change', 'Headache', 'Nausea']",1,MODERNA, 931021,MD,56.0,F,"Sore throat. Severe chills, body aches, headache, along with fever of 101.9 and nausea, vomiting. Severe left arm pain (site of injection). Home from work on January 6th, day of initial dose. Started with chills after arriving home at approx 8pm. Went to bed and woke sometime around midnight with the above described symptoms. Symptoms cont throughout the day (January 8th) . Finally out of bed by evening and was able to hold down food. Back to bed and woke sometime around 3 am after breaking a sweat. Fever was gone and my body cooler. Up that morning around 9. Normal, tolerable body aches, mild headache and left arm very sore but could tolerate it being touched. Side Note: I had contracted the virus in March 2020. The symptoms from the vaccine were so much worse than the actual virus. I am too scared to get the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Hctz, Emgality, metoprolol",None,"Htn, migraines",,Lisinipril,"['Chills', 'Fear', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Pyrexia', 'Tenderness', 'Vomiting']",1,MODERNA,IM 931022,VA,64.0,F,Headache; fever 101; aching. I am reporting this the day following the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,,,WRK,Celexa 20 mg,None. I did have COVID in November - ran a high temp for two weeks.,None,,None,"['Body temperature increased', 'Headache', 'Pain']",1,MODERNA,SYR 931023,ME,23.0,M,"Starting ~10PM: fatigue, muscle soreness. Overnight, fever (99.8), chills, aches, Headache, sore throat, fatigue and mild diarrhea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"Sertraline, Famotidine, Montelukast, Clonazepam, Adderall XR, Melatonin ER.",,,"COVID Pfizer Dose 1: fatigue, diarrhea, injection site pain","Sulfa, PCN, Mupirocin, Doxycycline, Garlic, Onion","['Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Myalgia', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931024,IN,23.0,F,"I had head pressure that felt like a headache In my temples and the back of my skull around 9-10 hours after the vaccine. Left arm pain starting about 11 hours after shot. Difficult to move arm without intense pain and intense pain at the slightest touch of the arm on or around the vaccination spot. Starting the morning after the vaccination, my glands in my neck were tender and aching like they do when I?m fighting off a cold, I had body aches that you would get if you had a fever for the entire day all over my body. I took ibuprofen that night and they started to go away and I felt hot like I was breaking a fever. I woke up the next morning which is 2 days after the vaccination and felt completely back to normal besides residual arm pain. This pain is bearable and I can move my arm with only a dull pain and I can touch the spot without intense pain however it is still painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PUB,100 mg sprinolactone once/day,,,,,"['Feeling hot', 'Head discomfort', 'Headache', 'Injection site pain', 'Nasopharyngitis', 'Pain', 'Pain in extremity']",1,MODERNA,SYR 931025,TN,30.0,F,"On January 7th (8 days after my vaccination) I noticed heat and redness about the size of my fist at the injection site. It had a well defined border and was slightly swollen but not painful. Yesterday, January 8th, the site was less red but larger and with a less well-defined border. Today, The site looks less red but is slightly larger in size. It looks as if the center of the site is returning to the normal skin color and the redness is remaining in the border. There is still no pain at the site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PUB,"Valcyclovir; St John's Wort; Turmeric; lion's mane, cordyceps, and reishi mushrooms.",,,,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 931026,OH,34.0,F,"Sore arm with swelling. During nighttime, woke with violent shivering, goosebumps, headache and nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,OTH,"Buspar, levothyroxine, lexapro, requip, multivitamin",None,"Anxiety, hypothyroid",,"Hydrocodone, metoprolol","['Chills', 'Headache', 'Nausea', 'Pain in extremity', 'Peripheral swelling', 'Piloerection']",1,MODERNA,IM 931027,AZ,25.0,F,Was good for a few days then have had such a bad head ache that I can not get rid of.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/07/2021,3.0,PUB,Zyertec,,Asthma,,Penicillin,['Headache'],1,PFIZER\BIONTECH,SYR 931028,IN,26.0,F,"Muscle and joint aches, nausea, chills. Worked 6am-1pm (went home early). Slept for 3 hours, no improvements. Hydrated, ate small dinner, went to bed. Woke up 4:45am for work and symptoms were gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Oral contraceptive, sertraline, pantoprazole",N/a,N/a,,N/a,"['Arthralgia', 'Chills', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,SYR 931029,MD,51.0,F,"c/o dizziness, near-syncope 10 minutes post-vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,,,anxiety,,NKDA,"['Dizziness', 'Presyncope']",1,PFIZER\BIONTECH,IM 931030,MS,63.0,M,"I had a very small, left sided C5 dermatome breakout of a rash that appeared to be herpes zoster (shingles). I?ve never had a rash like this before. It?s now been 2+ weeks and is fading, leaving me with mild burning and itching in same area. I went ahead and had 2cd dose on 1/7/21. FYI: I?m an Emergency Physician myself.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/24/2020,7.0,PVT,ASA,,,,,"['Burning sensation', 'Herpes zoster', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 931031,TX,44.0,F,"On 12-23-2020, I developed symptoms of sinus congestion along with a cough, fever, body aches and a tightness sensation in my chest. I got tested for Covid on 12-27-2020 and was positive. I also had diarrhea and nausea. I did telemedicine with my primary healthcare doctor and I discussed with him that I felt tightness with pressure sensation to my chest and he said that it was cause of my asthma and he told me to take prednisone medication.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/23/2020,5.0,PVT,"Lisinopril, Omeprazole, Zertex, Albuterol inhaler, Prednisone, Emetrix for migraines",none reported,,,"Amoxycillin, Cholerahexadine","['COVID-19', 'Chest discomfort', 'Cough', 'Diarrhoea', 'Nausea', 'Pain', 'Pyrexia', 'Sinus congestion']",1,PFIZER\BIONTECH,IM 931032,IN,21.0,F,"Severe body aches, fever, migraine Advil and Tylenol taken. Helped a little.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Synthroid, zonisamide, gabapentin",,"Hashimotos, asthma",,"Tree nuts, sesame seeds","['Migraine', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 931033,IL,29.0,M,FEVER,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,SEN,"DEEP SEA NASAL SPR TID,DIAZEPAM 2.5 MG HS,FAMOTIDINE 20 MG BID,FLUTICASONE NASAL SPR BID,MELATONIN 3 MG HS,MI-ACID GAS 80 MG TID,MONTELUKAST 10 MG DAILY,OFLOXACIN DRO 0.3% OTIC TO BOTH EARS BID,TERAZOSIN 2MG HS,TRANSDERM SCOP PATCH Q 72 HR",WAS POSITIVE FOR COVID 2 WEEKS PRIOR,"IDD, PARTIAL AGENISIS OF CORPUS COLLOSUM, STATUS POST CLEFT LIP & PALATE, SCOLIOSIS, HYPERSALIVATION, ALLERGIES, GASTROSTOMY, URINARY RETENTION,ILEOSTOMY",,CECLOR,['Pyrexia'],1,MODERNA, 931034,IN,27.0,F,"side effects lasted 24 hours. 12 hours after second dose, chills occurred. this was followed by fever and muscle aches. Highest fever was 101.7 F. side effects were bad enough to affect ability to do ADLs and to be able to go to work. Swollen lymph node in left clavicle since first dose got bigger and firmer. since symptoms have resolved swollen lymph node still there.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,UNK,"vitamin c, zinc",none,none,,none,"['Chills', 'Impaired work ability', 'Induration', 'Loss of personal independence in daily activities', 'Lymphadenopathy', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931035,NJ,44.0,F,"Injection site pain, swelling, tenderness, fatigue, headache, muscle pain, joint pain, chills, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,None,None,Mitral valve prolapse,,"Penicillin, sulfa, percocet","['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 931036,NH,47.0,M,"Raised itchy hives on back, backs of thighs, buttocks, feet, hands starting 12 hrs after receiving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,Sertraline,,Asthma,,,"['Pruritus', 'Skin swelling', 'Urticaria']",1,MODERNA,IM 931037,MD,41.0,F,"c/o feeling flushed within 15 minutes of being vaccinated. Blotchy rash noted to chest and neck. No SOB, no hives, no airway involvement. Transported to ED and al symptoms resolved upon arrival without intervention.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,WRK,"Benadryl, Pepcid and Zyrtec taken prior to vaccine",,"POTS, Mast Cell Activation syndrome",,multiple,"['Flushing', 'Rash', 'Rash macular']",1,PFIZER\BIONTECH,IM 931038,IN,51.0,F,Fatigue sudden. Headache. Took tylenol every 4 to 6 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/07/2021,6.0,PUB,"Prilosec, progesterone",No,Chronic EBV,,Meds,"['Fatigue', 'Headache']",2,PFIZER\BIONTECH,IM 931039,IN,44.0,F,"Injectiom sight became sore as the day progressed. Injection sight was extremely sore and sensitive 24 hours later. At 48 hrs the pain had mostly subsided. Awoke the next day (after injection, 1/8) with a fever of 101� and a headache. Fever lasted until the evening with some slight body aches. Patient took tylenol and it helped slightly. Lethargic and took two naps during the day. Day 3 (1/9) all symptoms were gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,UNK,Adepex Metformin Singular Spirolactone Zoloft,Head cold December 4th onset,Polycystic Ovarian Syndrome 10 positive shingles out breaks over the course of lifetime Covid positive July 10 Obese,"Flu shot 2018, age 42, approx 2 hour after shot became very ill with belly pain and uncontrollable diarrhea. Was ill the rest o",Sulfa,"['Headache', 'Injection site hypersensitivity', 'Injection site pain', 'Lethargy', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 931040,IN,27.0,M,"Nausea and drowsiness began 2.5 hours post injection, resolved 9 hours post injection. Sore and tender injection site (left arm), began 30 minutes post injection. Has improved, but still slightly tender 49 hours post injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Atenolol, Hydrochlorothiazide, Lisinopril",None,"High Blood Pressure, Migraines",,None,"['Injection site pain', 'Nausea', 'Somnolence']",1,PFIZER\BIONTECH,SYR 931041,IN,51.0,M,"14 hours after injection had fever of 101.2, six hours later 101.7. Fever broke then at 100 until 4pm. Fever of 101 again at 7pm till midnight. I have now been 9 hours without a fever. Only other symptoms injection site tenderness with mild redness, no swelling and intermittent severe headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,WRK,"Flonase, ibuprofen",No,Sinusitis,,No,"['Headache', 'Injection site erythema', 'Injection site pain', 'Pyrexia']",1,MODERNA,SYR 931042,IN,55.0,F,"Started around 6:00 pm on 1/7/2021 with headache, body ache, on 1/8/2021!i still had aches but started with 101.5 temp. Now on 1/9/2021 I feel fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/07/2021,6.0,PVT,"Lisinipril, synjardy X-ray, atorvastatin",,,,Ibprofen,"['Body temperature increased', 'Headache', 'Pain']",UNK,MODERNA, 931043,MD,36.0,M,c/o feeling dizzy and diaphoretic a few minutes after receiving vaccine. Was pale and clammy to touch. Laid down and given water and candy. Felt better after 15 minutes and discharged back to work.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,WRK,,,,,,"['Cold sweat', 'Dizziness', 'Hyperhidrosis', 'Pallor']",1,PFIZER\BIONTECH,IM 931044,NH,27.0,F,"Fever and chills began about 1 hours after vaccine, about 18 hours after vaccine I was getting up to take more Tylenol and did not feel well, I had a syncope episode in the bathroom (no issues as I sat on the floor before hand). I was unconscious for about 1-2 minutes. My blood pressure several minutes later was low (about 90/50 but I took it myself so may not be exactly accurate)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,SEN,Birth control,None,None,,None,"['Blood pressure decreased', 'Chills', 'Malaise', 'Pyrexia', 'Syncope']",1,PFIZER\BIONTECH,SYR 931045,NY,59.0,F,"right after vaccination, my arm started feeling slightly sore. Then by 9:30 pm- feeling more arm soreness up until today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PUB,"D3, C, Zn, CoQ10, incruse, qvar, omeprazole, rosuvastatin, lexapro, diltiazem, probiotics, montelukast",None,Asthma,Flu shot,Sulfa,"['Immediate post-injection reaction', 'Pain in extremity']",2,MODERNA,IM 931046,IN,28.0,F,"Sore arm, chills, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,UNK,,,,,,"['Chills', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 931047,MD,39.0,F,"c/o feeling flushed and elevated HR post vaccine administration. Vitals stable BP 155/88, HR 92, No CP, no sob. Recovered and discharged home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,Zyrtec,,,,"seasonal, sulfa drugs","['Flushing', 'Heart rate increased']",1,PFIZER\BIONTECH,IM 931048,IN,65.0,M,Sore throat. Muscle aches. Headaches. Cold like symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,PUB,None,None,"Diabetes, arthritis, high blood pressure, HCL, prostate cancer (remission)",,None,"['Headache', 'Myalgia', 'Nasopharyngitis', 'Oropharyngeal pain']",1,MODERNA,SYR 931049,TX,37.0,F,"onset of fever 30 minutes post-injection lasting approx. 1-2 hours. Three days later began w/headache, fever, body aches, fatigue, nausea, diarrhea.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,Metformin 1000 mg twice daily; Glypizide 10 mg daily,none,"diabetes, non-alcoholic fatty liver disease",,nkda,"['Diarrhoea', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931050,MI,58.0,F,1/1/21 minor lip swelling. Took 1 dose of Benadryl and it resolved within 2 hours. 1/2/21 minor eyelid swelling . Took 1dose of Benadryl and condition resolved overnight. 1/4/21 significant lip swelling. Took 3 doses of Benadryl. Condition resolved in 24 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,"Bc pills, Hydrochlorothiazide, Singulair, iron supplement, multivitamin, nitrofurantion",None,"High blood pressure, chronic UTIs",,"Environmental, lisinopril","['Lip swelling', 'Swelling of eyelid']",1,PFIZER\BIONTECH,SYR 931052,OH,58.0,F,"Fever 100.4 at 4 am. Muscle aches by 8 am, along with malaise, fatigue, headache. Blood sugar tested at 160 while fasting. Unable to move left arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Tylenol, ibuprofin, asprin, vitamin b-12, benadryl, calcium magnesium zinc, iron, fish oil, folic acid, glucosamine chondrotin, claritin, lovistatin, melatonin, metapropal succcinate, multi vitamin, probiotic, super eight complex vitamin c.","Diabetes, hypertension, UTI,","Hypertension, diabetes",,,"['Blood glucose increased', 'Fatigue', 'Headache', 'Injected limb mobility decreased', 'Malaise', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 931053,MD,39.0,F,"c/o feeling flushed and heart racing after vaccination. Vitals stable. P 134/87, HR 86, RR 16, Sats 94%. No CO, no SOB. Recovered and discharged home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,Zyrtec,,"Anxiety, TMJ",,Budesonide,"['Flushing', 'Palpitations']",1,PFIZER\BIONTECH,IM 931054,AL,35.0,F,"Chills, myalgia, fatigue, headache, nasal congestion, cough",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Prenatal vitamins, sertraline",Common cold mid december,None,,None,"['Chills', 'Cough', 'Fatigue', 'Headache', 'Myalgia', 'Nasal congestion']",2,PFIZER\BIONTECH,IM 931055,IN,64.0,M,"Confusion, numbness right cheek bone area, difficult to talk and concentrate for around 15-20 minutes. Felt better and didn?t seek treatment till next day, never heard back from Dr.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"Mycophenolic Acid 360 mg, Amlodipine 5 mg, Tachrolimus 1 mg x3, Metformin, Rovustatin 10 mg, Synthroid .125 mg, ICaps multivitamin and Aspirin 81 mg.",None,"Kidney transplant 8/24/2016, Quadruple heart bypass 01/12/2016, Type 2 Diabetes.",,Septra,"['Confusional state', 'Disturbance in attention', 'Hypoaesthesia', 'Speech disorder']",1,PFIZER\BIONTECH,IM 931056,CA,49.0,F,"Swollen, painful left axillary lymph nodes",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Propranolol, bupropion, lamictal, lysine, vitamin C, vitamin D, zinc, Claritin, ASA 81mg, turmeric.",None,Depression,,"Sulfa, niacin sensitivity","['Axillary pain', 'Peripheral swelling']",,PFIZER\BIONTECH,IM 931057,CO,33.0,M,"Fever of 102, unremitting for 2 days, severe myalgias, arthralgias, headache, and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,None,None,None,,None,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931058,FL,73.0,F,"Expanding swelling, redness, heat, itching left arm beginning 01/07/21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,OTH,"Latanoprost, Dorzolomide Timoril, amlodipine",None,"HTN, uretral prolapse, glaucoma",,"Adhesive, perfumes, Macrobid, Septra, Augmentin","['Erythema', 'Peripheral swelling', 'Pruritus', 'Skin warm']",UNK,MODERNA,IM 931059,AL,34.0,F,"Nausea, intestinal discomfort, lymphadenopathy in right axilla, severe headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,"Fluoxetine, Meloxicam, Vitamin B-12, Viviscal, Rayos, Humira",None,"Rheumatoid arthritis, Sjogrens",,"Ibuprofen, Methotrexate","['Abdominal pain', 'Headache', 'Lymphadenopathy', 'Nausea']",2,PFIZER\BIONTECH,IM 931060,NY,48.0,F,"12/30/20: L arm tender, warm, localized erythema at injection site. Fatigue, mild body aches, generalized headache. Left work at 09:30 am. Went home and slept. Took OTC Tylenol 1000mg. 12/31/20: called in sick. Fever 99.9, body aches, headache more posteriorly with sensitivity to touch. L arm increased erythema, warmth, tender. Took Motrin/Cetirizine po, and put Arnicare on L arm. 1/1/21: fever and generalized symptoms improved. L arm seemingly improved. Did not take any medications or topical to L arm. 1/5/21: L arm with increased erythema, warmth, tenderness. Took Motrin/Cetirizine po and used Arnicare to L arm. 1/6/21: L arm increased erythema, warmth, tenderness and induration. Measured L arm erythema at work approximately 5-6cm. Continued taking Motrin, Benadryl 50mg every 4 hours x 2 doses. Put Hydrocortisone cream to L arm as well as ice. Had a video conference with PCP, Dr. Antibiotic Keflex was ordered for 10 days. Told to stop taking after 5 days if improvement. 1/7/21: L arm still with erythema, induration, warmth, not as tender but was itchy. Continued taking Motrin/Cetirizine po, Hydrocortisone cream. 1/8/21: Erythema L arm seemed to spread out more with a surrounding ring, less tender but still with warmth and itchiness. Antibiotics received in the mail but bottle crushed and loose pills in the package. Took Motrin/Cetirizine po and Hydrocortisone to L arm. 1/9/21: L arm improved erythema, warmth and no induration noted. Still with itchiness. Obtained pictures from 12/30/20, 12/31/20, 1/6/21, 1/7/21, 1/8/21, 1/9/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,PVT,"multivitamin, fish oil",none,,,"codeine, lactose intolerant","['Fatigue', 'Headache', 'Impaired work ability', 'Induration', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Pain', 'Pruritus', 'Pyrexia']",1,MODERNA,IM 931061,ME,61.0,F,"Seven days after the injection, a red raised welt began to form at the injection site. Overnight, the welt increased in size and ultimately reached a peak diameter of approximately 2 inches. It became warm and painful (pain scale 5/10). I have a photo I can submit if desired.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,PVT,"Metoprolol, Losartan, Tylenol, Vit D, Glucosamine, Voltarin",,"High Blood Pressure Arthritis Complete radial tear of medial meniscus, left knee",,"Macrodantin, Tramadol, ?sulfa drugs","['Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Urticaria']",1,MODERNA,SYR 931062,IN,37.0,F,Very sore left arm. Worse soreness than a flu shot. Hurt to lift arm and lay on it. Severe soreness lasted about 24 hours. Mild sore throat but unknown if related to vaccine or if normal seasonal allergies.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Generic synthroid Daily multi vitamin Tylenol pm as needed,,Hypothyroidism,Sore arm following yearly flu shot.,,"['Oropharyngeal pain', 'Pain in extremity']",1,MODERNA,SYR 931063,IN,44.0,F,"1 hour after receiving the COVID-19 vaccine, I experienced a tingling sensation that started in my lips (right side only). This turned into an icy, burning sensation that traveled up my right cheek, ear and scalp and stayed for 2 hours. The feeling returned that night at an unknown time and I felt fine the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Ear discomfort', 'Paraesthesia oral', 'Skin burning sensation']",2,PFIZER\BIONTECH,IM 931064,IN,38.0,F,"I was to dizzy to drive myself home. Vomiting, headache, off balance, nausea, runny nose, horrible body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/1921,01/07/2021,36525.0,PVT,"Bascular, Lisinopril 20mg. Clonazepam 1mg",Covid symptoms,"Diabetes, cancer survivor, asthma",,None,"['Balance disorder', 'Dizziness', 'Headache', 'Nausea', 'Pain', 'Rhinorrhoea', 'Vomiting']",1,PFIZER\BIONTECH,SYR 931065,MA,54.0,F,"Full body hives with increased redness at injection site. 50mg benadryl taken- hives resolved, except for area at injection site. 1-2 inch circular, red, raised rash at injection site which lasted approximately 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,PVT,"Venlofaxin, clonazopan, protonix",,"Anxiety, depression,,Gerd",,Sulfa,"['Injection site erythema', 'Injection site rash', 'Rash papular', 'Urticaria']",1,MODERNA,IM 931066,MA,57.0,M,"HEADACHE, SEVERE JOINT PAIN, RIGHT UPPER CHEST PAIN, LETHARGY, FEVER, CHILLS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,NONE,NONE,HAD TAKEN INTRON-A (INTERFERON) IN 1999 FOR MELANOMA FOR 12 MONTHS,,NONE,"['Arthralgia', 'Chest pain', 'Chills', 'Headache', 'Lethargy', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931067,IN,23.0,F,"Dizziness and lightheaded, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,,,"High blood pressure, pre diabetic",,Morphine,"['Dizziness', 'Headache']",UNK,PFIZER\BIONTECH,SYR 931068,OH,36.0,F,"1/7/21 at 0850: received vaccine 1200 - left arm soreness 2200 - headache began 1/8/21 at 0000: severe chills, worsening headache and neck pain, temperature started to rise, muscle and joint aches began 0500 - chills and aches continued, temperature max of 102.2 0800 - severe muscle aches, fever remained around 102, pulse 130's, SO2 99% 0900-2100 - rested the entire day, unable to move much because my body aches were so severe, when I did get up to go to the bathroom, I could barely walk because my hips and knees hurt so much, headache so severe that I began getting nauseous and dry heaving, I took 650mg acetaminophen and 25mg Benadryl around noon and used ice packs on my neck and the back of my head, ate very little, no appetite, drank water and ginger ale, temperature fluctuated between 101 and 102 all day, came down to 99.6 after acetaminophen, but came right back up to 101 as it wore off 2200 - took 975mg Tylenol and 25mg Benadryl and went to sleep, temperature 100.9 1/9/21 - 0900 - woke up after sleeping all night, temperature 98.2, body aches and headache gone, feel normal",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,WRK,"Women's multi-vitamin, Vitamin D, elderberry syrup (homemade and contains elderberries, cinnamon, honey, cloves and ginger)",none,"in remission from kidney disease in 1996 (thought to be autoimmune that was accelerated by use of ibuprofen) that resulted in being put on 5 years of immunosuppressant therapy (Cyclosporine), then was diagnosed with Hodgkin's Lymphoma in 2003, stage 3B, underwent 6 months of chemotherapy, in remission since 2003",,"ibuprofen, penicillin","['Arthralgia', 'Body temperature increased', 'Chills', 'Decreased appetite', 'Gait disturbance', 'Headache', 'Myalgia', 'Nausea', 'Neck pain', 'Pain', 'Pain in extremity', 'Retching']",2,PFIZER\BIONTECH,IM 931069,,56.0,F,"Fever, body aches, lethargy, headach",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Synthroid, celexa, librax, lomotil, calcium, collegan",Laryngitis,Hypothyroidism Celiac disease,,Sulfa drugs Celiac disease,"['Headache', 'Lethargy', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 931070,IN,29.0,F,"Body aches the night of vaccine. Went away after ibuprofen. Reoccurred on the 8th around 4pm. And then extreme nausea at 6 pm . quick onset diareah at 1am with cramping. Vomiting occurred at same time. Just that one session, but nausea remained. Another round of diareah at 8am on 1/9",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,Zoloft,,,,"Latex, bee stings","['Diarrhoea', 'Muscle spasms', 'Nausea', 'Pain', 'Vomiting']",UNK,MODERNA,SYR 931071,CO,66.0,F,"Redness and large swelling at injection site, itchy, red area warm to touch. Wait and watch, no antibiotics at present time. Onset was about 10 days post-vaccine administration",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,01/04/2021,9.0,WRK,Symbycort inhaler bid Lisinopril 10mg q am Metformen 500mg bid Lantus insulin q hs Fosamax (unk dose) 1 tab q week,New onset diabetes; admitted to hospital in DKA for insulin gtt on 12/16/2020.,Asthma,,Penicillin Sulfa/Sulfite Levaquin Isovue CT contrast IV solution,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 931072,NY,41.0,F,6 days p inj noted upper rt arm redness itching that spreadto include most of lateral upper arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/06/2021,6.0,PVT,,,,,Methimazole,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 931073,NY,33.0,M,"Injection Site Pain, Severe, 12/28-1/1, Self-Resolved Fever, 12/28-12/29, 100.5F, Self-Resolved Chills, 12/28-12/29, mild, Self-Resolved Headaches, 12/28-12/30, Severe, Self-Resolved Malaise, 12/28-12/30, Severe, Self-Resolved Myalgias, 12/28-12/30, Moderate, Self-Resolved Arthralgias, 12/28-12/30, Moderate, Self-Resolved Dizziness, 12/28-12/30, Mild, Self-Resolved Lymphadenopathy, 12/28-12/30, Mild, Self-Resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Vega Protein Powder,None,None,,None,"['Arthralgia', 'Chills', 'Dizziness', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Malaise', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 931074,IN,39.0,F,Tongue and lips have mild burning and metallic taste. Symptoms seemed to increase from Wed- Friday. Benadryl taken Friday Feb 7 at 9pm. Symptoms are slightly better but tongue continues to have metallic taste and mild burning sensation. Face also has mild itching,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Night before had zomig nasal spray,Migraine night before and prior week,None other than migraines,,"Tree nuts, penicillin","['Dysgeusia', 'Oral discomfort', 'Pruritus', 'Tongue discomfort']",1,MODERNA,IM 931075,WV,39.0,F,"I have had the ""normal"" reactions such as; sore arm, ear and throat pain, headache, fatigue, and body aches. I have also noticed my neck hurting and this am I notice a knot like form on my left clavicle bone that was not there prior to the the vaccine. I have not had any treatment for this.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/09/2021,2.0,PVT,Pepcid Omeprazole Claritin Vitamin C Multi Vitamin,None,Reflux,,Pencilin,"['Ear pain', 'Fatigue', 'Headache', 'Neck pain', 'Nodule', 'Oropharyngeal pain', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH,IM 931076,IN,44.0,F,"Bad headache; left shoulder pain; left neck pain, stiffness; pain just above kidneys up to shoulder blade on left side",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Spironolactone, Zoloft, Adderall XR, Omeprazole, Mirapex, Womens daily vitamin, omega 3 fish oil, Zyrtec, Zinc, Magnesium, Diclofinac",None,None,,NKDA,"['Flank pain', 'Headache', 'Injection site pain', 'Musculoskeletal stiffness', 'Neck pain']",1,MODERNA,IM 931077,IL,37.0,F,FEVER 102.2,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,SEN,"ALBUTEROL NEB Q4H,BACLOFEN 30 MG TID,DULCOLAX SUP QOD,,DIAZEPAM 2.5 MG Q6H,FLOVENT HFA AER BID,MIRALAX 17 GM DAILY,GLYCOPYRROL 0.5 MG DAILY,ATROVENT VIA NEB Q8H (USED WITH ALBUTEROL),O2 AT 24% AT NOC AND WHEN IN BED,CALCIUM/VIT D DAILY,PHEN",NONE,"SEIZURE DISORDER, ANOXIC ENCEPHALOPATHY, SPASTIC QUADRIPLEGIA, EXCESSIVE SECRETIONS, RESPIRATORY DISTRESS, CHRONIC CONSTIPATION, DEVELOPMENTAL IMPAIRMENT TRACHEOSTOMY,GASTROSTOMY TUBE",,NSAIDS,['Pyrexia'],1,MODERNA,IM 931078,IL,32.0,M,"Subjective fevers and chills, mild nausea. Only lasted 4 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,None,None,Intermittent asthma,,None,"['Bursitis', 'Chills', 'Nausea']",2,PFIZER\BIONTECH, 931079,IN,54.0,F,Swelling and soreness at injection site. Swelling and tenderness in underarm area/lymph nodes,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"Allergy injections, folic acid, calcium, vitamin D",,,,"Seasonal, molds, dust","['Injection site pain', 'Injection site swelling', 'Lymph node pain', 'Lymphadenopathy', 'Oedema peripheral', 'Tenderness']",UNK,MODERNA,SYR 931080,WV,49.0,F,"15 minutes into post administration observation patient complained of dizziness. This dizziness intensified over the next few minutes. Patient moved to a cot in sitting position to obtain BP, O2, and pulse. Moved into a supine position and complaints of nausea started within 5 minutes. Patient then placed on side and began retching without vomiting. Patient was able to talk and drink sips of water. Complained of chest pain (described as pressure and similar to heart burn radiating to throat) and headache. 11:55am 911 contacted. Patient denied using or being prescribed nitroglycerin for previous chest pain complaints. Presence of urticaria on neck and upper chest led to the administration of 50mg diphenhydramine solution by mouth at 12:00pm. Rash dissipated. Continued monitoring patient's BP, O2, pulse. 12:09pm EMS arrived and monitored patient. Patient still complained of headache and nausea. Patient offered trip to ER at 12:14pm. 12:17pm agreed to ER transportation. Left facility for ER at 12:20pm with EMS.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,WRK,"gabapentin, alprazolam","Anxiety, reported chest pain with a scheduled follow up with cardiologist for stress test","Anxiety, neurological tumor",,Sulfa drugs,"['Chest discomfort', 'Chest pain', 'Dizziness', 'Headache', 'Nausea', 'Retching', 'Urticaria']",1,MODERNA,IM 931081,NY,52.0,F,- Strong injection site pain extending to neck and shoulder area,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,N/a,N/a,N/a,"Frequent body chills, 52, 12/18/2020, COVID -19, Pfizer/BioNTech",N/a,"['Arthralgia', 'Injection site pain', 'Neck pain']",2,PFIZER\BIONTECH,SYR 931082,GA,64.0,M,LOST SENSE OF SMELL,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/08/2021,3.0,PVT,NONE,NONE,NONE,,NONE,['Anosmia'],1,PFIZER\BIONTECH,IM 931083,IN,51.0,F,"Body aches, headache, fever up to 101.2, nausea, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PUB,Venlafexine. Vitamin D and C,COVID-19 started 12/7/20 diagnosed 12/11/20. Symptoms lasted until 12/21/20,None,,"Wheat, oranges, bananas, walnuts, augmentin, morphine, Prilosec, protonix, latex, omnicef, maxzide, linzess","['Dizziness', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 931084,OR,48.0,F,"Fever of 101 for three days. Around 8 pm on January 1st sever vertigo anytime changing position. Went to open MD who recommended epley maneuver . Was told to do this for ""several days"" and then come back if it did not go away. Maneuver was done for three days before vertigo went away, but constant dizziness for another three days, and then intermittent dizziness still ongoing. Called into work.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/01/2021,2.0,OTH,Ibuprofen. Vitamin D.,none,none,,NKA,"['Dizziness', 'Impaired work ability', 'Pyrexia', 'Vertigo']",1,PFIZER\BIONTECH,IM 931085,PR,43.0,F,"the area got hardened, hot and red.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,"Zoloft, Atacand, Vitamin C, Zinc, Vitamin B, Vitamin D",None,"High blood pressure, depresi�n","Influenza vaccine. The area got hard, red and hot.",Intolerance to Penicillin,"['Injection site erythema', 'Injection site induration', 'Injection site warmth']",2,PFIZER\BIONTECH,IM 931086,IN,26.0,F,Cervical and supraclavicular lymphadenopathy on the same side as injection. Worsened after second vaccine dose,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/17/2020,12/22/2020,5.0,PVT,Birth control Xyzal,None,None,,None,['Lymphadenopathy'],1,PFIZER\BIONTECH,IM 931087,PA,67.0,F,"on day 8 following the vaccine administration, I developed itching at the vaccination site (L deltoid). On day 9, in the morning I noticed redness, heat, and itching at vaccination site-for an area of about 4"" long and 2"" wide. Today, the area is slightly less reddened but still very itchy. I have no other signs or symptoms. I was responding daily to V-Safe check ins but the the last text that I received from them was on Wednesday, January 6. I have not been able to contact them to report the change in my signs and symptoms since this reaction has occured after their check-ins with me, stopped. I am a nurse and feel it is improtant for you to know all reactions which I why I am contacting you. I could not find another site or place to report this. Thank you!",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PUB,Levothyroxine,none,hypothyroid,,Lidocaine local??,"['Injection site erythema', 'Injection site pruritus', 'Vaccination site warmth']",1,MODERNA,IM 931088,FL,84.0,F,Headdache Trembling in the Body Tiredness Chills,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Losaltan 50mg Lebotirozine 88mg Gripizide 10mg two daily Tradjenta 5mg,No,High Blood Pressure Diabetic Artritis,,No,"['Chills', 'Fatigue', 'Headache', 'Tremor']",2,MODERNA, 931089,TX,45.0,F,"Fever, body aches, headaches, tiredness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,,,,,Zpak. Medrol,"['Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 931090,NC,54.0,M,Severe arm and shoulder pain. Unable to lift arm or move back and forth.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,Synthroid Crestor Aimovig Hydrocortisone Testosterone Fish oil Senna Multivitamin,N/a,Hypo pituitarism Hypothyroidism,,N/a,"['Arthralgia', 'Mobility decreased', 'Pain in extremity']",1,MODERNA,SYR 931091,IN,45.0,M,"Fever, treated with Tylenol Chills Body Aches Fatigue Symptoms lasted about 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Amlodipine 10MG Clonidine 0.2 MG Cetirizine 10MG HydrAlazine 25MG Metoprolol Tart 100MG Minoxidil 2.5 MG PotaChloride ER 20MEQ Spirono/HCTZ 25/25 Verapamin ER 240MG Pravastatin 40MG,"I had Covid with my first symptom started on Dec. 3rd 2021, tested positive on Dec. 7th 2020",High Blood Pressure,,None,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 931092,VA,42.0,F,Redness and warmth 1 inch by 4 inch that developed 9 days post vaccine. Treated for cellulite with keflex 500 mg 4x faily,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/08/2021,9.0,PUB,"Lisinopril 2.5 mg daily, dexilant 60 mg daily, fish oil, vit b complex, vitamin d",None,"Hypertension, high triglycerides, Gerd",,None,"['Cellulitis', 'Erythema', 'Skin warm']",1,MODERNA,IM 931093,PA,23.0,F,"Axillary pain started on day 4 (1/4) after vaccine and continued until day 7 which was so bad I could not sleep or move that arm. Took 1 Aleve for the pain. Then on day 7 axillary pain went away and a rash started to form on arm where vaccine was given. Day 8 rash spread at was bright red. Around noon on day 8 hives popped up next to left eye. On day 8 did a virtual doctor appointment and the NP prescribed antibiotics because she said the ""rash"" is cellulitis. At this time took zytec to help with the hives.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,,,,,,"['Axillary pain', 'Cellulitis', 'Injection site erythema', 'Injection site rash', 'Sleep disorder', 'Urticaria']",1,MODERNA,SYR 931094,IN,27.0,F,Mild body aches with moderate to severe body chills from 9pm until 5am the evening of the shot. Patient was ?freezing? despite multiple thick layers of clothing and bed linens. Unclear if there was a fever involved - temperature was never taken at home during the event.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,Zyrtec,Menstrating at the time of vaccination; no history of illnesses,"Severe seasonal allergies to pollen, grass, weeds, etc",,Zithromax antibiotic,"['Chills', 'Nasopharyngitis', 'Pain']",2,PFIZER\BIONTECH,IM 931096,IL,25.0,F,FEVER 103,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,UNK,"BACLOFEN 15 MG TID,DULCOLAX SUP DAILY,CLONAZEPAM 0.5 MG TID,FLOVENT AER HFA VIA PUFFS BID,KELNOR 1/35 DAILY,MIRALAX 17 GM DAILY,MONTELUKAST 4 MG HS,PRILOSEC 20 MG QPM,TOPIRAMATE 50 MG BID,",NONE,"CEREBRAL PALSY, ASTHMA, SEIZURE DISORDER, GASTROESOPHAGEAL REFLUX DISEASE, CHRONIC CONSTIIPATION,GASTROSTOMY TUBE",,NSAIDS,['Pyrexia'],1,MODERNA,IM 931097,NY,26.0,M,Extreme pain in upper left arm where vaccine was given. Can barely move left arm. Has been 24 hours and still extremely painful.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,OTH,None,None,None,,None,"['Injected limb mobility decreased', 'Injection site pain']",1,MODERNA,IM 931098,CT,51.0,F,"7 days after vaccine site started to itch. On the 8th day site was red, inflamed and warm to the touch. Mild pain upon palpation",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,PUB,Hydroxychloroquin 200mg Ibuprofen 600mg,,Hair loss,,codine Augmenten,"['Injection site erythema', 'Injection site pruritus', 'Vaccination site inflammation', 'Vaccination site pain', 'Vaccination site warmth']",1,MODERNA,UN 931099,MA,39.0,F,"I have a 16 month old daughter and am 15 weeks pregnant with my second, due date July 2, 2021. I noticed today redness and swelling at the injection site after showering, slightly itchy when touched",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/09/2021,11.0,PVT,"Levothyroxine, prenatal multivitamin, iron",None,None,,"Lamisil, bactrim","['Exposure during pregnancy', 'Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling']",1,MODERNA,IM 931100,KY,23.0,F,patient received dose 1 of moderna covid vaccine at 9:32am; pt c/o redness/irritation around chest /neck area at 09:42; 50mg oral benadryl and 20mg oral pepcid administered; 10:23 redness almost resolved and itching almost completely resolved; patient sent home with instructions on reporting to ER if symptoms should worsen and instructions on premedications for next vaccine. pt verbalized understanding of all instructions.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PHM,singulair flonase,none,otosclerosis,,precedex latex,"['Erythema', 'Skin irritation']",1,MODERNA,IM 931101,,34.0,M,"Vomitting, chills, fever, body aches. All symptoms were gone about 12 hours after onset",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,UNK,,,,,,"['Chills', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 931102,PA,34.0,F,"Redness, swelling, subcutaneous fluid at injection site. Still present after over a week. One week after administration onset of pain in armpit. Practicioner prescribed treatment with antibiotics for 5 days because of a likely cellulitis.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,SEN,Venlafaxine ER 37.5mg,,,,no known allergies,"['Axillary pain', 'Cellulitis', 'Fluid retention', 'Injection site erythema', 'Injection site reaction', 'Injection site swelling']",1,MODERNA,IM 931103,PR,24.0,M,"Fever, chills, cold sweats, fatigue, dry cough, headache, muscle pain, and weakness lasting 12 hours starting at around 24 hours after vaccine administration. Patient took two Tylenol 500mg to some relief at 2pm and again at 7pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,"Montelukast, alburerol",None,"Asthma, herpes",,Shellfish,"['Asthenia', 'Chills', 'Cold sweat', 'Cough', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 931104,NY,31.0,M,"Injection Site Pain, Severe, 12/27-12/28, Self-Resolved Chills, 12/27-12/28, mild, Self-Resolved Headaches, 12/27-12/28, Severe, Self-Resolved Malaise, 12/27-12/28, Moderate, Self-Resolved Myalgias, 12/27-12/29, Moderate, Self-Resolved Arthralgias, 12/27-12/28, Moderate, Self-Resolved Lymphadenopathy, 12/27-12/28, Mild, Self-Resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,PVT,Vegan Protein powder,None,None,,Ceclor Bactrim,"['Arthralgia', 'Chills', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Malaise', 'Myalgia']",1,MODERNA,IM 931105,VA,32.0,F,"Severe body aches, fatigue, headache, chills, fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 931106,NY,50.0,F,"Tachycardia, beginning 12/29/20, or noted at time of awakening, heart rate of 68-161 beginning at 6am-7am. I watch documents rate on 12/29/20 from 7am resting rate 76, walking rate of 140. This rate is not the normal as patient normally walks to work but this date chose to take a cab, rate of 140 not normal resting rate. Rate ranges 150-on 12/29-to 55-209 on 12/30/2020, resting rate of 66. Walking rate of 103, Did not not exercise rest of the week because of this elevated rate. Felt colder than normal. One week prior rate was 12/22/2020. Range was 59-127, resting 62, walking 107. Rate week of 1/5/2021 ranges 49-158, resting 55 and walking is 91. 1/8/2021 rate ranges from 54-145, resting 59, walking 100.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,None,None,None,,None,"['Echocardiogram normal', 'Electrocardiogram normal', 'Fibrin D dimer', 'Tachycardia', 'Thyroid function test normal', 'Troponin normal', 'White blood cell count decreased']",1,MODERNA,IM 931107,,34.0,F,"body aches, chills, headache, subjective fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,UNK,,,,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 931109,IN,35.0,F,01/07/21 tingling and numbness in whole right arm right after vaccine administration 01/08/21 woke up about 230am with severe body aches (flu like) and severe arm pain not just soreness where vaccine was given but whole upper arm that lasted all day and went on for almost two whole days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,none,slight cough,none,,mobic,"['Hypoaesthesia', 'Immediate post-injection reaction', 'Influenza like illness', 'Pain', 'Pain in extremity', 'Paraesthesia']",UNK,MODERNA,IM 931110,,26.0,M,"fever 100.5F, malaise, myalgia, headache, and rigors x 2 days. responded well to acetaminophen and ibuprofen",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Chills', 'Headache', 'Malaise', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931111,NY,30.0,F,Tinnitus,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,WRK,,,Nonserum Rheumatoid Arthritis Hashimoto's,,Lactose,['Tinnitus'],1,PFIZER\BIONTECH,IM 931112,NV,66.0,F,"Chills, headache, low-grade fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Bupropion SR 150 mg Diclofenac Sodium 75 mg Lisinopril 10 mg Atorvastatin 10 mg,None,None,,None,"['Chills', 'Headache', 'Pyrexia']",UNK,MODERNA,IM 931113,IN,26.0,F,"Fatigue, body aches for 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,WRK,,,,,,"['Fatigue', 'Pain']",2,PFIZER\BIONTECH,IM 931115,PR,58.0,M,"FEVER, CHILLS, FATIGUE, GENERAL MALAISE, HEADACHE, JOINT ACHE, ACETAMINOPHEN 250 EVERY 12 HRS ASPIRIN 250 EVERY 12 HRS",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,TOPROL XL OXYBUTININ LIPITOR PEPCID ASPIRIN 81 MG,NONE KNOWN,"HIGH BLOOD PRESSURE SINCE AUGUST 2020 AFTER COVID 19 IN JULY 14, 2020",,NONE KNOWN,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Malaise', 'Pyrexia']",1,MODERNA,IM 931116,TX,42.0,M,"Chills, high fever, and was very tired.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/28/2020,2.0,WRK,,,,,Penicillin and morphine,"['Chills', 'Fatigue', 'Pyrexia']",1,MODERNA,IM 931117,MA,39.0,M,"2 days after vaccination: fever of 100.4F, headache, rigors. As of today, symptoms persist",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,MIL,"Krill oil, vitamin D 5000 units, nasal fluticasone spray",none,chronic low back pain,,none,"['Chills', 'Headache', 'Pyrexia']",1,MODERNA,IM 931118,MI,67.0,M,Moderna COVID-19 Vaccine EUA Darker than normal urine for 2 days......I apologize if this is not considered an 'adverse event'. it is unusual for me.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Tylenol 3 Flomax Advodart Multi Vitamin Vitamin B12 Calcium Omega 3,none,Chronic pain,,none,['Chromaturia'],1,MODERNA,IM 931119,WA,50.0,M,"Sharp piercing left sided chest pain that radiated to left shoulder and back 7-8/10 on pain scale. Taking a deep breath made pain worse but no associated shortness of breath. Pain worsened with attempting to eat food. Severe symptoms lasted 2-3 hours and then subsided. Troponin and other cardiac markers negative. No history of GI, cardiac, or pulmonary disorders. Mildly present the first half of the next day (1-2/10) until afternoon then completely resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"tadalafil, MVI, Vitamin D,",None,BPH,,None,"['Back pain', 'Chest pain', 'Injection site pain', 'Laboratory test normal', 'Painful respiration', 'Troponin I normal']",2,PFIZER\BIONTECH,IM 931120,NY,44.0,F,"Eight days after injection, I noticed a red lump, warm to the touch at injection site. No pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,spironolactone 50mg,none,,,,"['Injection site erythema', 'Injection site mass', 'Injection site warmth']",1,MODERNA,IM 931121,NC,60.0,M,light headache Fever for 48 hrs reaching 102,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,,,,,,"['Headache', 'Pyrexia']",1,MODERNA,IM 931122,KY,47.0,F,09:32--pt received dose 1 moderna vaccine 09:37-pt c/o generalized itching/mild redness on forearms and abdominal area pt took 25mg oral benadryl of own supply and 25mg oral benadryl pharmacy supply + 20mg oral pepcid 10:15--pt reports resolution of symptoms and verbalizes understanding of premedications for next vaccine and will report to ER should symptoms change,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PHM,hctz singulair daily allergy medication,hypertension endometriosis acid reflex,endometriosis acid reflux,,none,"['Erythema', 'Pruritus']",1,MODERNA,IM 931123,,43.0,F,Headache Body aches Nausea Arm pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PUB,Zinc 5mg Enalapril 5mg,,Hypertension Asthma,,Penicillin Sulfa Zantac,"['Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 931124,NH,44.0,F,"Onset of pain of the Arm 1/6/2021. Following day increasing redness and pain. on 1/8 8 x 13 cm on Left arm. Where insertion site was warmth, redness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"Topamax, Effexor, Maxalt, Lorazepam, Oxycodone/Tylenol, Ambien, estradiol","Chronic Migraines, Anxiety","Migraines, Anxiety",,"Rash with blood transfusions, Sulfa Drugs","['Alanine aminotransferase increased', 'Erythema', 'Full blood count normal', 'Injection site erythema', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,SYR 931125,WI,45.0,F,Diffuse muscle aches Nausea Fever/chills,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Advair Wellbutrin Albuterol Synthroid,No,Asthma Hypothyroidism,,No,"['Chills', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931126,IN,29.0,F,"Arm tingling, more prevalent in right arm, face tingling R>L. Tingling started at 0030 1/8, only lasted a few hours. Intense body aches, chills, low grade temp, started at 00:30 and ended by 1800. Still experiencing intermittent chills, flushing, and sweating.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,WRK,Nortriptyline Adderall multivitamin,none,ADD Migraines,,none,"['Chills', 'Flushing', 'Hyperhidrosis', 'Pain', 'Paraesthesia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931127,MA,30.0,M,"Severe chills late that night of the second vaccination. Migrane as well as light sensitivity. Preassure in the head as well as vertigo. Chills have almost resolved this morning into the next day after vaccination. The migranes, head preassure and vertigo still persist.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,Dayquil and Nyquil,Cold,None,,None,"['Chills', 'Head discomfort', 'Migraine', 'Photophobia', 'Vertigo']",2,PFIZER\BIONTECH,IM 931128,CA,43.0,F,"Hives began on hands early morning Wednesday. Friday hives on legs. Saturday both arms, legs, feet have hives. Have headache since receiving vaccination. Swollen, painful axillary lymph nodes on side of injection from Monday and still sore today on Saturday.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,PVT,"Lexapro, Trazodone, Montelukast",None,"Eosinophilic Esophagitis, depression, insomnia, migraines",,Propylene Glycol,"['Lymphadenopathy', 'Sinus headache', 'Urticaria']",2,PFIZER\BIONTECH,IM 931129,CO,66.0,M,"Both eyes became very itchy on Saturday January 2. Sunday morning January 3, my left eye was very red. Both eyes very dry and itchy. By noon Sunday, left eye redness gone. Both eyes itchy. Monday the 4th, ithcy gone but both eyes very dry. By Wednesday the 6th all back to normal. No other symptoms related to vaccination during this period.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/03/2021,3.0,PVT,none,none,none,,none,"['Dry eye', 'Eye pruritus', 'Ocular hyperaemia']",1,MODERNA,IM 931130,MN,34.0,M,"headache, muscle pain, joint pain, chills, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,"Adderall, 10 mg 3xdaily Finesteride, 1 mg daily Aspirin, 81 mg daily",none,none,,none,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 931131,MN,40.0,F,"Shot was given lower in arm than it should have been. There is a hard, warm and red bump where given. Its starting to get itchy as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Metoprolol Citalopram Imitrex Wellbutrin Lisinopril-HCTZ Metformin ER Tordol Stelara,Migraine,Obesity Depression High Blood Pressure Diabetes Polycystic ovarian syndrome PMS Psoriasis Infertility,,Percocet Shellfish Fentynal Iohexol Tramadol Erythromycin,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 931132,NH,48.0,F,"Localized reaction- redness, swelling, itchy. L, warm to touch. Treated with cortisone cream",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/08/2021,9.0,MIL,"Zyrtec, Singulair, fluticasone nasal spray, levothyroxine 150 mcg, multivitamin, vit D 1000 mg, b complex, vit C 1000 mg, probiotics,l, omeprazole, fish oil",None,"Hypothyroidism, allergies, obesity",,"Cats, dust, trees, morphine, demoral, sulfa drugs, pcn, adhesive tape","['Erythema', 'Local reaction', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,SYR 931133,IN,29.0,F,"Started with chills, then fevers, then headaches and extreme fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,WRK,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 931134,TX,38.0,M,"Chills, body aches, joint pain, weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,"Zyrtec, flonase",None,None,,"Penicillin, aspirin","['Arthralgia', 'Asthenia', 'Chills', 'Pain']",1,MODERNA,IM 931135,WI,42.0,F,"Pt noticed that heart rate increased to 112 on watch about 10 minutes after vaccine was given. She also felt dizzy for about 30 seconds but this resolved on its own. Pt reported to staff. Vital signs were taken Temp 97.9, heart rate 84, BP 124/85. Pulse was regular. Pt denied any ongoing dizziness or other symptoms. She was given apple juice and monitored for another 15 minutes with no further symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,,,,,,"['Dizziness', 'Heart rate increased']",2,PFIZER\BIONTECH,IM 931136,IN,37.0,M,"Debilitating headache, bodily fatigue, soreness at injection site, partial loss of mobility of injected limb, nausea, vomiting. Adverse events subsided partially, or mostly, after 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,None,None,None,,None,"['Asthenia', 'Fatigue', 'Headache', 'Injected limb mobility decreased', 'Injection site pain', 'Nausea', 'Vomiting']",1,MODERNA,SYR 931137,PA,51.0,F,lose stools and charlie horse in both legs in the middle of the night,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PUB,"lexapro 15 mg once a day lasix .25 mg once a day bood pressure medication .05 mg once a day b12 shot once every three weeks mvi, apple cider vinger gummy, vit c, vit d, airborne, vit d, lysine, flaxoil, iron,",none,gastric by pass,,asa and nsaids,"['Diarrhoea', 'Muscle spasms']",1,MODERNA,IM 931138,NY,27.0,F,"No symptoms until 1/7/21 when my arm was itchy, pink, and raised. It was same temperature as my arm, but it was approximately 3 inches wide and 2 inches long, and pretty much an oval where I had the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/07/2021,8.0,PVT,Vyvanse,None,None,,Sulfa antibiotics,"['Erythema', 'Pruritus', 'Skin swelling']",1,MODERNA,SYR 931139,MD,28.0,F,"Hours after shot I noticed a large red swollen lump. On 12/31/2020 I showed this to one of my providers and he told me to give him a call if it had not disappeared by 1/4/2021. The redness was slightly better on 1/4 but then became drastically worse on 1/5/2021. I had a low grade fever(100.7), spreading redness, pain, itching, and swelling of left arm, on 1/5/2021 and was told to go to urgent care. I went to urgent care on 1/6/2021 and was diagnosed with cellulitis. My injection site was measured and I was instructed to go to the hospital if after given first and second dose of antibiotic, symptoms did not improve. Redness began to decrease and I did not go to the hospital. As of today, 1/9/2021 my left arm is mildly red and swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,WRK,,,,,,"['Cellulitis', 'Erythema', 'Pain in extremity', 'Peripheral swelling', 'Pruritus']",1,MODERNA,SYR 931140,IN,60.0,F,"Low grade fever, chills, lower back ache, headache Took Tylenol. Whole episode lasted less than 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,UNK,"Furosemide, Potassium, Dexilant, Bupropion, Prempro,",,,,Percocet,"['Back pain', 'Chills', 'Headache', 'Pyrexia']",UNK,MODERNA, 931141,GA,60.0,F,"Symptoms began 1.6.21 evening from 1AM forward lasting through 1.8.21 5AM. Sympotms included: moderate-severe headache, nausea, chills/Moderate, whole body aches-moderate, site inject RT aches, imbalance/dizziness, symptoms highly mimicked how I felt when I had COVID-19 in Novemeber.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,none,COVID-19 positive,none,,none,"['Balance disorder', 'Chills', 'Dizziness', 'Headache', 'Injection site pain', 'Nausea', 'Pain']",UNK,MODERNA,SYR 931142,VA,56.0,F,"Severe vertigo, vomiting for 12 hours. Vertigo for 5 days. Out of work for 5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/03/2021,2.0,WRK,"Calcium, vitamin D,",no,no,,no,"['Impaired work ability', 'Vertigo', 'Vomiting']",1,PFIZER\BIONTECH,SYR 931143,IN,43.0,F,Body aches severe Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,Atenolol Calcium Colestrium Desmopresin Effexor,,,,Sulfa Tetracycline,"['Headache', 'Pain']",2,PFIZER\BIONTECH,IM 931144,IN,57.0,F,On Christmas day I did not feel well. I tested positive for Covid on 12-27-2020. Went to the hospital and got infusion and after that I came home and quarantined an returned to work on 01-05-2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/24/2020,3.0,PVT,"Metformin 1000mg BID, Venoflaxin 150mg BID, Vasartan 320mg OD, Pantoprazole40mg OD, Emlodipin 5mg, Lasix 40m BID",None reported,"Diabetes, HBP, hiatal hernia",,"Penicillin, Cefalexin","['COVID-19', 'Infusion', 'Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 931145,NY,50.0,F,"Felt tightness and pressure on her throat, called EMS and treated with 25 mg of Benedryl immediately at 10:15 during her post observation. Happened 10 minutes after receiving the vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,OTH,Imitrez pen for migraines - took yesterday 1/8/2021,None,None,,None known,['Throat tightness'],1,MODERNA,IM 931147,WA,39.0,F,"tachycardia (130-140's), HTN 140/100's, near syncope, nausea, temp 99.0 within minutes. That evening face rash and itching. Following day flu like symptoms as well as sore throat and congestion.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,calcium 1000mg QD prenatal vit QD vit d 6000u QD fish oil 1000mg QD trazadone 50mg prn,none,none,,"sulfa, augmentin","['Aggression', 'Hypertension', 'Influenza like illness', 'Nasal congestion', 'Nausea', 'Oropharyngeal pain', 'Presyncope', 'Pruritus', 'Rash', 'Tachycardia']",1,PFIZER\BIONTECH,IM 931148,IL,22.0,M,Injection site pain - present Tiredness - 24hrs Headache - 24 hrs Muscle pain - 24 hrs Chills - 24 hrs Joint pain - 24 hrs Fever (101.2�f) - 24 hrs Nausea - 24 hrs Malaise - 24 hrs Swollen lymph node (left armpit only) - present,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931149,SD,60.0,F,"Cough, shortness of breath, SPO2 decreased to 88-90% 24-36 hours after vaccine administration. Normal vital signs on 1/9/21 at time of urgent care visit",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"Meloxicam (15mg tab), flucticasone propionate (50 mcg/actuation nasal spray), losartan (50mg tab), aspirin (81mg EC tablet), ergocalciferol (Vitamin D2 oral), bupropion SR (150 mg 12hr tab)",Hx of COVID-19 illness on 11/22/2020,"Multiple joint pain, hypertension, hyperlipidemia, former smoker",,,"['Blood chloride decreased', 'Chest X-ray normal', 'Cough', 'Dyspnoea', 'Eosinophil count increased', 'Eosinophil percentage increased', 'Full blood count', 'Hyponatraemia', 'Metabolic function test']",1,MODERNA,IM 931150,OH,53.0,F,"overheated shaky, sweaty, fatigue decreased appetite, nausea, unable to lift left arm and left arm pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,,no,breast cancer,,,"['Decreased appetite', 'Fatigue', 'Feeling hot', 'Hyperhidrosis', 'Injected limb mobility decreased', 'Nausea', 'Pain in extremity', 'Tremor']",1,MODERNA,IM 931153,MI,31.0,F,"Developed a ""scratchy throat approximately 20 minutes post vaccination. Symptoms worsened and she developed shortness of breath. Required evaluation and treatment in the Emergency Department. Received Benadryl, dexamethaxone, famotidine and solumedrol. Second COVID vaccine, no reaction with the first vaccine. ED provider notes below: This patient presented due to concern for allergic reaction to COVID-19 vaccine and was seen by myself immediately upon arrival. When in triage the triage nurse noted her oxygen saturation was 81% so she was placed on 2 L nasal cannula and brought directly back to her room. When placed in the room she was hooked up to the monitor and her oxygen saturation was 100% and I took her off of the nasal cannula and her oxygen saturation remained in the upper 90s. She had no stridor and respirations were nonlabored. She was speaking without difficulty and had no vocal changes. She did not appear to be in any acute distress. Her posterior oropharynx was widely patent and she had no uvula or tongue swelling or lip swelling. She did have some blotchiness to the upper chest area but no hives. Abdomen was soft and nontender. Pulse was regular. Blood pressure was stable. She was nontoxic in appearance. An IV was established and the patient was given Decadron and Benadryl for initial treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,None,None,none,,None,"['Dyspnoea', 'Oxygen saturation decreased', 'Throat irritation']",UNK,PFIZER\BIONTECH,IM 931154,MD,41.0,F,I immediately felt tingling that traveled down to my fingers of my left arm and hand after receiving the modern COVID-19 vaccination. I felt some numbness at the site of injection immediately after. I told the nurse or medical providers at the facility and they told me to sign up forvsafe.cdc.gov to monitor my symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,None,Eczema,None,,None,"['Immediate post-injection reaction', 'Injection site hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 931155,TX,59.0,F,Approximately 5 minutes after receiving the injection a warm/hot tingling sensation began in my body rising up from my chest to my head. My throat and chest became tight. My heart began to race. It was difficult to breath. I motioned for help. A physician on site came over. Emergency services was called. An EKG was done in the rescue. It was normal. Most of the symptoms resolved approximately 20 minutes later. I did not go to the hospital. I left feeling not completely right with some discomfort in my chest. One week later my right arm at the injection site became hot and red 4 inches by 3 inches by 4 inches around and the soreness returned. It is still slightly pink with soreness.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,Losartan 50mg Pantoprazole 40mg B12 injection monthly,None,Asthma B12 Deficiency,,Codeine Droperidol,"['Chest discomfort', 'Dyspnoea', 'Electrocardiogram normal', 'Feeling hot', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Palpitations', 'Paraesthesia', 'Skin warm', 'Throat tightness']",1,MODERNA,IM 931156,IL,29.0,M,Fever over 101.5 for 24 hours Headache Body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,Prozac Propranolol,,,,Sulfa,"['Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931157,PR,53.0,F,"My left arm (at shoulder), at the injection site, is still red, warm to touch and it itches. This morning (01/09/2021) I felt pain under my arm (in my armpit).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,"Vitamin C, Vitamin D3, Vitamin E, Fish Oil, Complex B100, Invokamet, Ramipril, Adderall, Meloxicam",No,"Diabetes, Hypertension",,No,"['Axillary pain', 'Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",UNK,MODERNA, 931158,OH,26.0,F,"Red, raised bumps all over legs, arms and groin on week after vaccination. Bumps are itchy and welt-like",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,WRK,OTC one a day prenatal vitamin,,,,N/a,"['Rash', 'Rash erythematous', 'Rash papular', 'Rash pruritic', 'Urticaria']",1,MODERNA,IM 931159,IL,38.0,F,"Fever, chills, headache, upset stomach started at 1am. Unable to sleep until 3:45am. Woke at 7am with temp of 99.2 and chills, headache. It is now 10:15am and fever is gone but headache remains.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,None,None,None,,None,"['Abdominal discomfort', 'Body temperature increased', 'Chills', 'Headache', 'Pyrexia', 'Sleep disorder']",1,PFIZER\BIONTECH,IM 931160,IL,66.0,F,Within 5 min of injection: front 3rd top of tongue started getting numb and I got a metallic taste in mouth. That dissipated fairly quickly. Mostly gone within 30 min. Went home. Left side of Parotid started swelling - at 12/24/2020 in the morning. I didn't notice anything wrong until I tried to eat breakfast. Very painful. Swelled up very large. Couldnt' eat much for four days when I finally saw my dr (28th). and he gave a prescription: an antibiotic and that started helping. When I salivated it would start to swell. Pain was worse the first day and I massaged it alot to force saliva out of the grand. Tried to eat for very bland and very little on one side of mouth. Augmentin Amox-Clad 875 mg. was the antibiotic I was given and that took about 24 hours to help.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/24/2020,6.0,PVT,Armour thyroid mp 180 mg/day,No,-throat infections; strep throat; mono - but of my life - tumor behind right parotid and had to have right parotid removed to remove the tumor - 1999,,No,"['Condition aggravated', 'Dysgeusia', 'Feeding disorder', 'Hypoaesthesia oral', 'Parotid gland enlargement', 'Salivary gland pain', 'Ultrasound scan']",1,PFIZER\BIONTECH,IM 931161,IN,30.0,F,"Immediately after getting the vaccine my left arm was sore, which became worse in the evening, causing me pain to raise my left arm. Around 5 pm the same day, I started having body aches and had the chills. Then around 8pm I spiked a fever which reached up to 102.0 Fahrenheit, which I treated with Tylenol. In the morning (1/9/2021) the fever returned at 101.2 Fahrenheit, which I treated with Tylenol again.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,none,none,Hashimoto's disease,,Mango,"['Chills', 'Immediate post-injection reaction', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931162,KY,50.0,F,"Developed severe right leg pain, small rash on my right buttocks, tenderness at the LS joint, subsequently diagnosed with shingles on 1/7/21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,Depakote 250mg 4 tablets daily,None,"Epilepsy, Anxiety, History of Traumatic Subdural Hematoma, Herpes",,"Pristiq, Zoloft","['Arthralgia', 'Herpes zoster', 'Musculoskeletal pain', 'Pain in extremity', 'Rash', 'X-ray of pelvis and hip']",1,PFIZER\BIONTECH,IM 931163,OH,41.0,F,"Began with a sore arm at injection site then could not lift arm higher than four inches without excruciating pain, muscles throughout body began to tense up and hurt, joints and hips ached and hurt, headache all over the top of my head, sweat then chills, tired, light headed, nauseated, temperature topping 103 degrees",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,"Lexapro (20 mg), Deplin, Prilosec",Covid - symptoms started 12/23/2020; released back to work on 01/03/2021,No,,No,"['Arthralgia', 'Body temperature increased', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Heart rate increased', 'Hyperhidrosis', 'Influenza virus test negative', 'Injected limb mobility decreased', 'Injection site pain', 'Myalgia', 'Nausea', 'Pain']",1,MODERNA,IM 931164,OH,28.0,F,"Received vaccine on 12/31/2020, developed mild arm pain following day at injection site. On 1/05/2021, developed mild lip swelling around 1630, that increased to hives on upper back and hips. At 2030, lip swelling had significantly increased and throat felt ?weird? and tight. Fianc� drove to Emergency Department, was deemed not necessary to have epinephrine at the time. Discharged with four day course of prednisone and famotidine. On 1/09/2021, returned to Emergency Department for bilateral hand swelling, increased hives on arms, back and sides. Epinephrine 0.3 mg administered IM right thigh, discharged with another script for prednisone. There were no other changes to lifestyle including lotions, body washes, perfumes, food, etc. that could have potentially triggers reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,PVT,"Trazodone 50mg Nightly PRN, whey protein supplement, amino acid supplements.",None.,Obesity.,,Buspirone & bupropion,"['Feeling abnormal', 'Injection site pain', 'Lip swelling', 'Peripheral swelling', 'Throat tightness', 'Urticaria']",1,MODERNA,IM 931165,OR,32.0,M,Patient developed localized induration and erythema of approximately 5 cm over a period of 3 -5 minutes and mild generalized non pruritic non urticaric rash. He developed mild diaphoresis . There were no other respiratory symptoms or cardiac symptoms. Patient was treated with PO Benadryl 25 mg. Over the course of an additional 30 minutes observations period all symptoms resolved with the exception of a minimal erythema of 1-2 cm peri-insertion site.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None,None,HTN,,None,"['Hyperhidrosis', 'Induration', 'Injection site erythema', 'Rash']",UNK,PFIZER\BIONTECH,IM 931166,ME,37.0,F,transient chest warmth and tingling in palate. self resolved in 2 minutes. no medications given. monitored 30 minutes after symptoms resolved,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,"amlodipine, famotidine prior to vaccine",,,hypertension and tachycardia,lobster,"['Feeling hot', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 931167,IN,68.0,F,"Extreme fatigue, chills, body aches, and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,UNK,Synthroid / generic Vitamin D EPA/DHA Atenolol Billberry montelukast,Double Ear Infection Sinus Infection Covid / 6 weeks prior to Vaccine,mild asthma controlled high blood pressure hypothroid,,none,"['Chills', 'Fatigue', 'Headache', 'Pain']",1,MODERNA,IM 931168,MA,46.0,F,I got very light-headed when I got up this morning. I felt like I was going to throw up when I brushed my teeth. I then got very dizzy and fell back into bed to avoid passing out. That was 3 hours ago and I think I just need to stay in bed today. Also - I'm taking 800 mg ibuprofen q6h for the arm pain. Pain is tolerable with the medication.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,Synthyroid MVI Calcium/Vit D,None,None,,NKA,"['Dizziness', 'Nausea', 'Pain in extremity']",1,MODERNA,IM 931169,IN,20.0,F,"chills, body aches, fever, redness and soreness at injection site, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,"['Chills', 'Fatigue', 'Injection site erythema', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA, 931170,MI,63.0,F,"Day following vaccine, had extreme fatigue, headache, low grade fever, injection site redness and swelling. All symptoms subsided after the first 48 hours with the exception of the injection site redness that lasted for 5 days along with itching at the site. The redness is now gone but itching at the site still remains at the injection site as of today-day 10. I consider the itching to be a minor side effect, and not severe enough to prevent me from getting the 2nd vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,UNK,"Metformin, Lisiniprol, Atorvastatin, Levothyroxine, Gabapentin, Preservision Areds 2, Multi-Vitamin, Vitamin D, Calcium, Probiotic",none,"pre-diabetes, thyroid",,nka,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Pyrexia']",1,MODERNA,SYR 931171,TX,39.0,F,Had a rash appear a week and half after my shot. Rash stayed not even for 24 hours and then gone. Rash appeared the first day that I stopped getting text messages to check on my shot process.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,UNK,Spark,None,,,No,['Rash'],1,MODERNA,SYR 931172,MT,62.0,M,insidious onset lateral right foot pain at fibularis tendons from lateral malleolus to the base of 5th metatarsal,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"Areds2 supplement, saffron supplement (30mg daily), Terbinafine 250mg daily",none,none,3-4 hour headache following dose 1 of pfizer covid vaccine on day 2 (12-18-20),no,['Pain in extremity'],2,PFIZER\BIONTECH,IM 931173,TX,63.0,M,Patient developed 3rd cranial nerve palsy on right eye. Pt had a CT and reports no aneurysm or abnormalities.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,PVT,,,,,NKDA,"['Computerised tomogram normal', 'IIIrd nerve paralysis']",1,MODERNA,IM 931174,CT,28.0,M,"11 days after initial vaccination: vaccination site became warm swollen and red. Physically felt lightheaded/dizzy with near syncope episode and heart palpitations. Took Zyrtec, Benadryl and went to emergency room.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/08/2021,11.0,UNK,,,,,,"['Dizziness', 'Palpitations', 'Presyncope', 'Vaccination site erythema', 'Vaccination site swelling', 'Vaccination site warmth']",1,MODERNA, 931175,IL,39.0,F,"No treatment needed yet. Headache, sore throat, dizzy, fatigue temp 99.4, bilateral arms and feet painful pins and needle sensation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,None,None,Pcos,,None,"['Dizziness', 'Fatigue', 'Headache', 'Oropharyngeal pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 931176,NY,53.0,F,"fever, soreness at injection site, body aches and chills. These began approximately 6:30pm night of injection, continued into the next day. Taking advil every 4 hours and this has helped to stop the fever but the rest of the symptoms continue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"calcium, biotin, aspirin, Norvasc, Atorvastatin",none,"high cholesterol, high BP",,none,"['Chills', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 931177,IN,30.0,F,3am woke up freezing cold and shivering. Temp 99.7. 4:30am temp was 101.3. Took 975mg Tylenol. 8:00am fever broke. Headache. Took more Tylenol 2:00pm headache. Took migraine medication. Laid down to sleep. 5:30pm woke up. Temp 100.7. Took 650mg Tylenol. 8pm fever broke. Headache better. *fatigue and soreness at injection site all day* Saturday 1/9/21 Feeling much better. No fever or headache so far. 11:30am.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,UNK,,,,,,"['Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Nasopharyngitis']",2,PFIZER\BIONTECH,SYR 931178,IN,28.0,F,"Swollen Lymph Node in left armpit/general left armpit swelling with pain (approx. circumference of a baseball). Began 4-5 days post first vaccination dose and has grown in size and worsened in pain. Makes movement of arm uncomfortable and occasionally painful. At the time of writing this report, it has been 1 week since the first dose and the adverse event persists without signs of alleviation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/07/2021,5.0,PVT,Birth control - Levonorgestrel and Ethinyl Estradiol Tablets USP,None,None,,None,"['Axillary pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 931179,,27.0,F,"Headache, nausea, diarrhea, hot flashes, mild fever, loss of concentration/focus, fatigue, muscle aches. 12/23-1/9 (present) 2 virtual dr visits, recommended Tylenol and rest",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/23/2020,1.0,PVT,Tylenol PRN,,"Fibromyalgia, migraines",,gluten,"['Diarrhoea', 'Headache', 'Hot flush', 'Loss of consciousness', 'Myalgia', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH, 931180,MD,71.0,M,"Throughout the day, January 8, 2021, I found myself short of breath and my joints were painful more that usual. My resting heartrate went from 62 to 71-73. I felt lightly dizzy and certainly weaker than usual. I had a headache much of the day and when I got home, I immediately went to bed I was so tired. I slept for over 10 hours but did not feel refreshed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,UNK,atorvastatin multi-vitamin baby aspirin,none,high cholesterol hospitalized with Covid for 12 days April 2020 44 sessions of radiation therapy for residual cancer post radical prostatectomy,,none,"['Arthralgia', 'Asthenia', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Headache', 'Heart rate increased']",1,MODERNA,IM 931181,FL,66.0,F,"Sore arm beginning the day after the injection and lasted for 2 days. A second side effect occurred on January 6 - a swollen lymph node under my left arm, which was not the injection arm. However, I had lymph nodes removed due to breast cancer in 2001.. Lymph node is normal on January 9.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,OTH,"multivitamin, calcium, low dose aspirin, coQ-10, magnesium, Phillips'Colon Health, Pepcid AC, Singulair, Atorvastatin, Melatonin, Metamucil",none,"osteoporosis, GERD",,"Augmentin, Percocet","['Lymphadenopathy', 'Pain in extremity']",1,MODERNA,IM 931182,MD,65.0,F,"red, swollen, itchy blotch around injection site most notable 8 days after injection, reaction developed slowly over the course of the 8 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,OTH,azelastine nasal ceturuzine docusate-senna fiber fluticasone nasal pseudoephedrine zolipidem,none,,,iodine adhesive sulfa drugs penicillins tetracycline,"['Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Rash macular']",1,MODERNA,IM 931183,IN,45.0,F,No major side effects but I have had a headache that is persistent for a couple days. I have taken tylenol which helps but the headache has been very persistent. It is still on and off on day 3 but getting better.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,UNK,"Vit c, calcium,b12,vit d3",,,,Seasonal allergies,['Headache'],1,PFIZER\BIONTECH,SYR 931184,NJ,46.0,F,Very dizzy when I received the vaccine and the following day woke up with a severe headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,,,"High blood pressure , anemia",,,"['Dizziness', 'Headache']",1,MODERNA,IM 931185,WI,55.0,F,"At about 1030 patient started feeling light headed & dizzy. Had patient tip down & elevated feet. Staff checked heart rate (within normal), O2 with pulse ox (within normal) and blood pressure (elevated - 160/112). Patient at first stated started to feel better, but around 1050 blood pressure became more elevated 200/105). Instructed patient to go DR/ER treatment/outcome unknown once patient got to ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,SEN,unknown,unknown,"asthma, thyroid disease",,onion,"['Blood pressure increased', 'Dizziness']",1,MODERNA,IM 931187,FL,65.0,F,"Within 45 min of injection: redness/ flushing both sides of nose & chin; cheeks; numbing sensation at lower jaw/ base of face; as I massaged my jaw, the numbing sensation moved upward to ear/cheek bone to forehead and towards eye socket; some headache.... mostly face stuff mainly on left side which is side where shot given. 2.5 hours later, some numbness going away but still present.....especially in left cheek at eye and left forehead....mainly left side of face.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,"Levothroxyine, Estradiol, Meloxicam, Vit B12, vitamin Defense complex (D, zinc, elderberry, B, etc)",None,None,,"Mold, mildew, dust, palm trees, Mango tree sap","['Erythema', 'Flushing', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia eye']",UNK,MODERNA,SYR 931188,OR,51.0,F,"Within five minutes after the vaccine administration the pt reported R arm tingling, feeling ""different"" and spotty non-confluent erythema and pruritis over affected arm, upper chest, posterior neck. She reported feeling faint and began to have mild hyperventilation. Vital signs remained stable and WNL, lungs were clear with good air movement and there was no mucosal involvement. Pt was treated with PO bendryl. Over the course of 45 minutes her rash faded and her sense of pruritis also lessened. She was able to return to work with no further symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,cymbalta,No recent acute illnesses,"Anxiety, Depression, Migraines",,"PCN, TCN -","['Dizziness', 'Erythema', 'Feeling abnormal', 'Hyperventilation', 'Paraesthesia', 'Pruritus']",UNK,PFIZER\BIONTECH,IM 931189,FL,79.0,F,Local reaction to COVID-19 vaccine-Cellulitis of left upper arm Prescribed Doxycycline hyclate 100mg and PredniSONE 10mg,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,PVT,"Metformin, ACTZ, Losartan, Amlodipine, Pravastatin and Propranolo",none,diabetes and high blood pressure,,none,"['Injection site cellulitis', 'Local reaction']",1,MODERNA,IM 931190,IN,25.0,F,"After the first dose in December I only had a sore arm. However after this second dose on 1/7 I experienced moderately severe chills, achy feelings, sore throat, and headache lasting from about 7am until I took ibuprofen at 5pm. The symptoms subsided after taking ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,UNK,None,None,None,,Amoxicillin,"['Feeling cold', 'Headache', 'Oropharyngeal pain', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 931191,PA,35.0,F,Lower gums and lower lip bleeding gums about hour 1/2 after the inj. It lasted about 3-4mins. Pain at the inj site.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,WRK,"Sertraline 30mg,",no,no,,no,"['Gingival bleeding', 'Injection site pain', 'Lip haemorrhage']",1,PFIZER\BIONTECH,SYR 931192,NH,36.0,F,"Pt developed lightheadedness and mild headache 15 minutes after the vaccination. HR was noted to be 120. After several minutes of observation, vital signs normalized and pt reported that her symptoms resolved. She elected to go home (was not driving) and declined EMS services.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PUB,Meformin,none,diabetes,,nka,"['Dizziness', 'Headache']",1,MODERNA,IM 931193,AZ,50.0,F,"Deltoid muscles (noticeably more than even tetaus vax) and less so joint soreness R shoulder, possibly slight fatigue - started approx >6hrs after shot. Did a 40min dance workout (a little sluggishly) but doable. Hot tub x 15 min, naprosyn, and feel good now despite some fatigue (which may be unrelated to vaccine).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,none,none,none,,nkda,"['Arthralgia', 'Fatigue', 'Sluggishness']",2,PFIZER\BIONTECH,IM 931194,CT,34.0,F,"Cellulitis on site of injection (left upper arm), mild malaise, burning discomfort, low grade fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/07/2021,7.0,WRK,Loestrin 1/20,none,none,,"PCN, Dicloxacillin","['Burning sensation', 'Full blood count normal', 'Injection site cellulitis', 'Malaise', 'Metabolic function test normal', 'Pyrexia']",UNK,MODERNA, 931195,IN,48.0,F,Headache mild,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Pantoprazole,None,Gerd,,Nka,['Headache'],UNK,MODERNA,IM 931196,MD,21.0,F,I developed a bumpy itchy skin rash at the injection site 1 week after my vaccine. The bumps are itchy and are only at the injection site (upper left arm),Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/09/2021,7.0,PVT,,,,,Cats,"['Injection site reaction', 'Rash pruritic']",1,MODERNA,SYR 931197,IN,51.0,F,"Swelling and pain of armpit, axillary lymph nodes, axillary breast tissue, under arm at axilla. Pain and swelling of deltoid",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,OTH,Lamictal Levothyroxine Protonix Fluoxetine Naltrexone+buproprion Gabapentin,None,Hypothyroidism Depression GAD Insomnia GERD,,,"['Arthralgia', 'Axillary pain', 'Lymphadenopathy', 'Swelling']",2,PFIZER\BIONTECH,IM 931198,OH,52.0,F,"Drenching sweat at 3AM day after vaccine, tested positive 1/8/2021 on Binax now POC test 1/8/2021, employer encouraged me to report , thinking it might be a false positive and might be related to vaccine. Have cold like symptoms and headache. Had a negative POC on 1/6/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PUB,"Motrin, progesterone, flexaril, Effexor, adderal, vit D, celixibib, Benadryl, Zyrtec,",N/a,N/a,,Nka,"['COVID-19', 'Headache', 'Hyperhidrosis', 'Nasopharyngitis', 'SARS-CoV-2 test positive']",1,MODERNA,SYR 931200,PA,19.0,F,about 25 minutes after the injection pt felt flushed with mild tachycardia and headache. Pt improved with rest on the exam table. Bp returned to normal immediately and bp remained normal at 126/84. Pt returned to work but sx reoccurred about 30 minutes later and she again rested with resolution of sx until she went home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Novolog, Singular, Nexplanon, Flonase,",,Diabetic type 1,,Sulfa drugs,"['Blood glucose normal', 'Flushing', 'Headache', 'Tachycardia']",1,MODERNA,IM 931201,CT,44.0,F,I exp pain in my cheek and swelling of my face. On 12/27 I went to urgent care with a rash and diagnosed with Shingles. I had blisters with redness scalping which fell off on 1/8.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,PVT,"Gapbentin 300, Singular, Hydrochlorothiazide",No,Sleep Apnea,Flu (6 yrs ago before Egg Allergy diagnosis),"Eggs, Penicillin, Clindamycin, Allergies","['Blister', 'Erythema', 'Facial pain', 'Herpes zoster', 'Rash', 'Swelling face']",1,PFIZER\BIONTECH, 931202,NY,33.0,F,"Expected symptoms in first 24 hours - fatigue, muscle aches, extreme arm pain. These symptoms resolved after a day, but I have had a poorly delineated area of erythema, warmth, edema and pruritus at the injection site that began on day two post-vaccine and has been increasing in size until today (day 5 post-vaccination). Started as a small (2 cmx2cm) wheal, now appears as painful/itching and warm blanching urticaria that takes up the entire width of my upper arm and half the length of the upper arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,WRK,Junel Fe Vitamin B12 supplement Calcium and Vitamin D supplement,None,None,,Bactrim,"['Fatigue', 'Injection site erythema', 'Injection site oedema', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site urticaria', 'Injection site warmth', 'Myalgia', 'Pain in extremity', 'Pallor']",1,MODERNA,IM 931203,NY,64.0,F,"sore arm with redness and swelling which resolved after 3 days and then on day 9 post vaccine (1/5/21) developed redness, warmth; raised rash and itching at injection site (3 inch diameter) which has not yet resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,WRK,Claritin Aleve,none,none,,none,"['Erythema', 'Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Injection site warmth', 'Pain in extremity', 'Peripheral swelling', 'Rash papular']",1,MODERNA,IM 931205,AL,48.0,F,"Fever (101.4), Body Aches, Headache Treatment - Acetaminophen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,WRK,Levothoroxine,None,None,,No,"['Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931207,NJ,70.0,F,"Moderna COVID-19 Vaccine EUA Although I had arm pain bad enough to wake me in the night 30 and 31 December, that was not surprising. What surprised me is that the site (about 9 cm round) became very red and very itchy a full week later (01/05/2021) and is still pink and itchy now. This is not at all serious, and Benadryl cream reduces the itching. I am reporting it only because it is not listed as a side effect on the documentation or CDC website.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PVT,"Levothyroxin 25 mg, Azelaic acid 15%, Zyrtec-D, red yeast rice, Vitamin D3",None.,GERD,,"penicillin, ophthalmic sulfa, pollen, dust, mold","['Injection site erythema', 'Injection site pruritus', 'Pain in extremity', 'Sleep disorder']",1,MODERNA,IM 931208,NY,52.0,F,"Received the vaccine on 1/5/2021 On 1/6/2021Approximately 24 hours after vaccine patient noted sore throat, lost voice, voice raspy took Benadryl with relief of symptoms the following day 1/7/2021 (could not take Benadryl due to working and concern over being tired), symptom returned On the evening of 1/7/2021, symptom completely resolved pt concerned over if this was angioedema ,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,not known,not known,not known,,not known,"['Aphonia', 'Dysphonia', 'Oropharyngeal pain']",1,MODERNA,IM 931210,KS,31.0,F,Received second dose of Pfizer vaccine. The next day had a mild headache and axillary lymph node swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Headache', 'Lymphadenopathy']",2,PFIZER\BIONTECH,SYR 931211,OR,31.0,M,"Approximately five minutes after vaccination the patient developed linear erythema extending into the right distal forearm and ulnar aspect of the hand. This was mildly pruritic. there were no other systemic cardiac, respiratory, or GI symptoms. Vital signs remained stable and WNL. Treatment was started with 25 mg PO Benadryl. Over the next 30 minutes the symptoms significantly lessened. Patient was discharged without further signs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,None,none,None otherwise healthy,,"NKDA, or allergies to environmental","['Erythema', 'Rash pruritic']",UNK,PFIZER\BIONTECH,IM 931213,MI,23.0,F,Redness at injection site - lasting 48 hours Pain at injection site/sore arm - lasting 48 hours Low grade fever (99.5F) - started 2nd day lasted for 24 hours Generalized body aches - started 2nd day lasted for 24 hours Headache - started 2nd day lasted 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,,,,,None,"['Headache', 'Injection site erythema', 'Injection site pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931214,SC,25.0,F,Low grade headache days 1-current: Ibuprofen: Reduced Reported adverse event: Moderate/severe arthralgia: Ibuprofen: Reduced,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/07/2021,3.0,PVT,"Prozac, multivitamin",None,"Depression, generalized anxiety",,None,"['Arthralgia', 'Headache']",1,PFIZER\BIONTECH,IM 931215,OH,58.0,M,"Severe chills and feeling ""sick"" started 10 hours after injection on 1-7-2021. Went to bed and chills continued. Took Tylenol x 1 dose in the middle of the night. Temp the following morning, 1-8-2021, was 102.1. Treated with Tylenol and rest through out the day. Temp at the evening on 1-8-2021 was 101.4. Chills on and off throughout the day. Injection site sore but no redness. Temp resolved on morning of 1-9-2021. Injection site still sore. Continuing to take Tylenol PRN",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Lisinopril OTC Omeprazole,"Covid 19 tested + on December 2, 2020","Kidney cancer, Left nephrectomy 2015",,None,"['Body temperature increased', 'Chills', 'Injection site pain', 'Malaise']",1,MODERNA,IM 931216,PR,35.0,F,Severe rash around neck area. Warmth in the area of the rash,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Synthesis Flonase,,Hypothyroidism,Varicella,Morphine,"['Feeling hot', 'Rash']",2,PFIZER\BIONTECH,IM 931217,MD,32.0,F,"On 12-26-2020 I started to have fever, chilis, loss of taste and headaches. I got diagnosed with Covid on 12-29-2020. I habe lingering of shortness of breath.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/26/2020,3.0,PVT,"Albuterol inhaler 2 puffs every 4 hours, Zofran 8mg",None reported,None reported,,Sulfa medications ( gets hives),"['Ageusia', 'COVID-19', 'Chest X-ray normal', 'Chills', 'Dyspnoea', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH,IM 931218,MD,49.0,F,"About 10 minutes after vaccine administration, patient explains that she experienced numbness over her entire body. Patient also stated that she felt hot over her entire body. Nurse advised patient to remove extra layers of clothing. Patient?s Initial Blood Pressure taken was 162/100, patient drank a sports drink, vitals rechecked 10 mins later ; BP 136/90, Pulse 84. Patient reported feeling better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,OTH,Zolpediem Loratadine (generic Claritin) Inhaler-as needed,Tension headache week of vaccination,None,,No known allergies,"['Blood pressure increased', 'Feeling hot', 'Hypoaesthesia']",1,MODERNA,IM 931219,NV,46.0,F,"Fever not helped by medication (motrin or tylenol) lasting at least 12 hrs, ranging from 101 to 104.6, from 5 am to 5 pm on the day following the injection. Also experienced body aches, chills, headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"Losartan potassium, gabapentin, ibuprofen.",None,"Psoriatic Arthritis, connective tissue disease.",,No known allergies,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 931220,MI,22.0,F,"Headache, Severe Injection Site Pain and Swelling, 99.5 degree fever, muscle aches, fatigue. Treatment- Over the counter allergy medication, and pain meds, ice pack and heating pack. Not much relief at all.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,"Zyrtec, Venlafaxine, Busiprone, Vitamin C",,,H1NI and Flu Shot combo,"Amoxicillin, Penicillin, Sulfa, Cefzil, Cyclobenzaprine, Codeine","['Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 931221,NJ,61.0,F,"Day 2 of 1/5/2021 vaccine, temp of 102.4 day 3, temp of 100.5 day 4 temp of 100.5 day5 temp normal",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,none,none,none,,none,"['Body temperature increased', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 931222,TN,61.0,F,"nausea, regurgitated twice at different times of day, muscle aches, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/07/2021,6.0,PUB,tumeric and Estroven,none,HTN,,none,"['Chills', 'Influenza virus test negative', 'Myalgia', 'Nausea', 'Regurgitation', 'SARS-CoV-2 test negative']",1,MODERNA,IM 931223,AL,24.0,F,Chest tightness Shortness of breath on exertion,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PVT,None,None,Asthma,,Amoxicillin Clindamycin,"['Chest discomfort', 'Dyspnoea']",1,PFIZER\BIONTECH,IM 931224,TX,39.0,F,"Pt experienced extreme fatigue and sleepiness the day following her second vaccination for Covid 19 and was found by her family after collapsing on 1/6/21 at 05:30. Upon arousal, she experienced headache, vomiting, weakness, difficulty speaking and difficulty walking with lower extremity weakness. She was taken to urgent care and subsequently admitted for evaluation at hospital and found to have a normal chemistry, blood count, normal lumbar puncture and normal imaging of her neck and brain. Discharge summary notes 3/5 strength and hyporeflexia throughout. Pt had televisit consult with psychiatry and neurology. She is subsequently to be discharged to a Facility without explanation for her sudden onset of progressive lower extremity and vocal weakness. She is noted to have a history of shellfish allergy. She experienced mild symptoms after the first vaccination, but no neurologic or vascular symptoms at that time.",Not Reported,,Not Reported,Yes,4.0,Yes,N,01/04/2021,01/05/2021,1.0,PVT,"Levothyroxine 200 mcg, Vyvanse 60 mg",NONE,"Hypothyroidism, ADHD",,"SHELLFISH, CECLOR","['Asthenia', 'Blood thyroid stimulating hormone normal', 'CSF cell count normal', 'CSF culture', 'CSF protein normal', 'Computerised tomogram head', 'Computerised tomogram head normal', 'Fatigue', 'Full blood count normal', 'Gait disturbance', 'Headache', 'Hyporeflexia', 'Lumbar puncture normal', 'Metabolic function test normal', 'Muscular weakness', 'Somnolence', 'Speech disorder', 'Spinal X-ray normal', 'Syncope', 'Vitamin B12 decreased', 'Vomiting']",2,PFIZER\BIONTECH,IM 931225,VA,49.0,F,"Achy, mild dry cough, low grade fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,OTH,No e,None,Graves disease,,"Mango, nail dip powder, saw dust","['Cough', 'Pain', 'Pyrexia']",1,MODERNA,IM 931226,CT,31.0,F,I got the vaccine on the 27th and within 20 minutes I had tachycardia and a headache. My heartrate was 115 and my blood pressure was high. The next day I had extreme fatigue and arm pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,WRK,Prenatal,,,,,"['Fatigue', 'Headache', 'Hypertension', 'Pain in extremity', 'Tachycardia']",1,MODERNA,IM 931227,ME,25.0,F,Dizziness and tingling in the hands,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PVT,,,,,None,"['Dizziness', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 931228,CA,48.0,F,"Employee Health notified several days after first vaccination that she had a sore throat, felt cold, ""brief asthma attack"" one hour after being vaccinated. Did not seek medical care. Inhaler used and symptoms went away 15-20 minutes later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,PVT,,,,,,"['Asthma', 'Feeling cold', 'Oropharyngeal pain']",1,PFIZER\BIONTECH,IM 931229,VA,40.0,F,"Vaccine 12/31/20: Had arm soreness for 2 days then resolved. Day 9 (1/8/21), I noticed redness (2in x 2 in), hard knot/swelling, warmth to touch, slight itchyness and achyness. Day 10 (today 1/9/21), swelling went down, itchyness resolved (but redness, warmth, achyness still there).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,PUB,Naturemade multi-vitamins (no change),none,none,,none,"['Erythema', 'Nodule', 'Pain', 'Pain in extremity', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,IM 931230,IL,32.0,F,"extreme tiredness, headache, left side tingling/numbness (left arm to left jaw), dizziness and near syncope, body spasms, and left sided chest pain (worse with palpation)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,PVT,"Levothyroxine, vitamin D",none,Hashimoto hypothyroidism,,"ibuprofen, shrimp","['Chest pain', 'Dizziness', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Muscle spasms', 'Paraesthesia', 'Syncope']",2,PFIZER\BIONTECH,IM 931231,MA,58.0,F,"Initially, just pain, redness, swelling at injection site. about 4 days after vaccine developed pain in medial portion of ipsilateral breast and axilla. slight swelling of nodes. no breast lump",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/03/2021,5.0,UNK,Lisinopril Sertraline,NONE,HTN,,NONE,"['Axillary pain', 'Breast pain', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy', 'Mammogram', 'Ultrasound breast']",1,MODERNA,IM 931232,TX,37.0,F,"Rash on chest, then rash on right arm below injection site. Severe joint pain that is still going on.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PHM,"Zyrtec, Valcyclovir",,Migraine,,Nkda,"['Arthralgia', 'Injection site rash', 'Rash']",1,MODERNA,SYR 931233,FL,71.0,M,"Slight fever (100.4), Swelling and tenderness in injection area, headache, fatigue, chills lasting approximately 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,UNK,None,None,High blood pressure,,None,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Pyrexia']",1,MODERNA,SYR 931234,IL,26.0,F,Around 2 am the following day the side effects I was experiencing were fatigue and body/muscle aches (severe aches in my lower back and hips). This lasted the entire day until I went to bed around 10 o'clock. I had to use a heating pad for my back to reduce the pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,Only birth control,No,No,,No,"['Arthralgia', 'Back pain', 'Fatigue', 'Myalgia', 'Pain']",UNK,PFIZER\BIONTECH,SYR 931235,,36.0,F,"Redness, itching and soreness appeared 10 days after vaccine received. No issues encountered initially.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/08/2021,10.0,PHM,,,,,,"['Erythema', 'Pain', 'Pruritus']",1,MODERNA,IM 931236,TX,38.0,M,Redness and swelling at the site of injection 8 days after receipt of the Moderna Covid vaccine. Size was 2-3 inches in diameter and warm to touch with mild discomfort.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,PHM,None.,None.,None.,,None.,"['Injection site discomfort', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 931237,MD,32.0,F,"After 10 minutes, throat began to become numb/tingly/itchy. Then at 20 minutes, I started to have difficulty swallowing. I told the medical provider who was there in the observation room. My vitals were stable. They sent me to the ER to be watched and observed for 6 hours. my throat's numb/itchiness/tingling went away, but remained difficult to swallow until the next morning. My vitals stayed stable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"Apriso, Orsthyia, Lexapro, Wellbutrin",none,"Ulcerative colitis, Low Blood Pressure","6 months old, reaction to Pertussis vaccine which included 2 days of high fever, staring spells and need to go to hospital to be","Macadamia nuts, Duricef, Penicillins, Sulfa drugs, augmentin, azithromyocin,","['Dysphagia', 'Pharyngeal hypoaesthesia', 'Pharyngeal paraesthesia', 'Throat irritation']",1,PFIZER\BIONTECH,IM 931238,CA,62.0,M,Moderna COVID-19 Vaccine EUA - I have experienced the following : The injection site is very tender to the touch. The soles of my feet have become numb. Slight exhaustion through the first 24 hours after the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,80 mg aspirin 1 tablet Citrucel,none,atrial fib Gilbert's syndrome,,none,"['Fatigue', 'Hypoaesthesia', 'Injection site pain']",1,MODERNA,SYR 931239,IL,55.0,F,"2 inch red area around injection, fever, aches, fatigue, headache Taking tylenol and ibuprofen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Lipitor,Effexor,Norvasc,Toprol,baby aspirin",none,"hypertension,high cholesterol,depression",,none,"['Fatigue', 'Headache', 'Injection site erythema', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931240,IN,92.0,M,"No treatment - Very sore arm - red streak below injection 2 in"" wide and 4 in"" long Spent next day (Friday) after shot in bed most of the day. Didn't eat all day - wasn't hungry. Felt all washed out, no energy - much like COVIT that I contacted 1st week of August 2020 - but not as bad The next day (Saturday)I felt much better with some energy. Ate a good breakfast",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,Metoprolol Furosemide Pota Chloride,,A-fib - but not taking blood thinner Pace Maker,"Tetanus, Codeine",,"['Asthenia', 'Decreased appetite', 'Fatigue', 'Injection site streaking', 'Pain in extremity']",1,MODERNA,IM 931241,IL,59.0,F,temperature 100.2 chills and body ache and headache,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,OTH,no,no,"sneezing allergies, thyroidism",,no,"['Body temperature increased', 'Chills', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 931242,CA,61.0,U,Pt with scratchy throat and dry cough approximately 20 minutes after receiving her 1st dose of Moderna vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Azelastine (ASTELIN) 137 mcg (0.1 %) Nasl Aero Spray Use 2 Sprays in each nostril 2 times a day 30 mL Xeljanz XR 11 mg Oral 24hr SR Tab Take 1 tablet by mouth daily 30 tablet,n/a-see below,? OSTEOARTHRITIS OF BILAT ANKLES 08/22/2007 ? LACTOSE INTOLERANCE 11/21/2007 ? RHEUMATOID ARTHRITIS 07/16/2008 ? CONGENITAL ABSENCE OF THE UTERUS 10/07/2009 ? PPD POSITIVE 11/12/2009 ? MIGRAINE 01/23/2012 ? HX OF RETAINED HARDWARE (REMOVED) 05/22/2012 ? INTERMITTENT ASTHMA 04/20/2016 ? ACUTE APPENDICITIS 06/13/2016 ? HX OF APPENDECTOMY 06/28/2016 ? LATENT TB OF LUNG 11/10/2016 ? LONG TERM TOFACITINIB THERAPY 06/07/2017 ? DEQUERVAINS TENOSYNOVITIS 04/12/2018,,Hydrocodone-acetaminophen Isoniazid Leflunomide Non-steroidal Anti-inflammatory Agents Sulfa (sulfonamide Antibiotics) Bacitracin,"['Cough', 'Throat irritation']",1,MODERNA,IM 931243,NY,58.0,F,"itchy arm, redness, mild swelling at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PVT,"Kepra, albuterol,",asthma,asthma brain tumor removed 2012,,"Codine, aspirin","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 931244,IN,43.0,F,"Approx 9 hours after receiving the vaccine I started having muscle aches, high fever 102-105, joint pain and nausea. The next day I developed a bad headache that I currently still have along with fever. I?m alternating Tylenol with Ibuprofen. I have not called my doctor yet as it?s the weekend but will on Monday.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Aller-Tec, Nortriptyline10mg, Fluticasone Nasal Spray, Azelastine eye drops",Had a positive covid test 11/30/2020 and symptoms for 2weeks. Still have some nasal congestion.,"Atypical migraines, seasonal allergies",,Sulfa,"['Arthralgia', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",UNK,MODERNA, 931245,CA,33.0,F,"Body aches and chills. Requiring Motrin 600mg to relieve pain. Even with 600mg of Motrin, body aches are still felt present. Relieved pain from 8/10 to a 1/10.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,None,None,None,,Sulfa,"['Chills', 'Pain']",2,PFIZER\BIONTECH,IM 931246,IN,34.0,F,"Was being monitored for 15 minutes. About 7 minutes after vaccine a fine rash started on left arm, spread to chest and other arms. Mild itchiness. No shortness of breath, no lip swelling, no tingling. Self medicated with 50mg Benadryl. I called her 1-9-21 at 9:50am. No rash, no itchiness. No issues at this time. Instructed she may want to pre-medicate or at least bring with her for her 2nd dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Duloxetine, Metoprol SucE, Sharobel, Fluticasone, Motelukast",none,COPD,,Bees,['Rash'],1,PFIZER\BIONTECH,IM 931247,IL,38.0,F,"Feeling lightheaded about 15 minutes after vaccination. Denies any other symptoms No swelling, hives, or respiratory symptoms noted. Patient calm, speaking voice monitored. Dr. called & interviewed patient. Patient observed additional 15 min & reported sx improved before leaving. 38 y/o F who c/o dizziness after vaccination No other complaints Exam - unremarkable Plan - home with monitoring Unlikely to be allergic Rxn",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PUB,0,0,0,,"PCN, clyndomycin, Seasonal allergies",['Dizziness'],1,MODERNA,IM 931248,IL,39.0,F,Complained of racing heart. Rested. Drank water. Paced outside of car. Complained of numbness in thumbs. Fully alert and verbal. VS WNL. Escorted patient to restroom. Patient states s/s resolved. Unlikely to be allergic Rx,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PUB,Albuterol,Asthma,Asthma,,None,"['Hypoaesthesia', 'Palpitations']",UNK,MODERNA, 931249,IL,41.0,F,Patient became flushed - face about 5 minutes after vaccination. Denies any other symptoms. No swelling or rash noted. No respiratory symptoms noted. Unlikely to be allergic RX.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PUB,None,None,None,,None Seasonal allergies,['Flushing'],1,MODERNA,IM 931250,IL,,F,"-tachycardia, flushed -lung sounds clear -pulse come down, but cheeks reamined flush. -administered 25mg Benedryl; 40mg Pepcid AC 53 y/o F who c/o facial flushing after vaccination No other complaints Exam - cheeks flushed otherwise negative Plan - Benadryl & Ranitidine PO. home monitoring Possible mild allergic reaction",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PUB,Vit D,none,none (gene mutation),,Sulfa,"['Flushing', 'Tachycardia']",UNK,MODERNA,IM 931251,IL,59.0,F,"patient complained of tingling in lips & tongue. Vitals taken; airway checked - no signs of swelling. Onset @ 1235, 8 minutes after injection. Lasted for ~ 10 mins then subsided. No rash/itch. Agree with assessment unlikely to allergic rxn",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,"history of IBS, thyroid, depression (nortriptoleum, paroxetine, bupropion)",none,IBS,,none,['Paraesthesia oral'],UNK,PFIZER\BIONTECH,IM 931252,IL,20.0,F,"10/30-tested + for COVID; recovered @ home suffers from chronic anxiety after 10 mins after vac, patient thought throat was Scratchy & closing. leading to crying/hysteria/panic attack. Once attended to, all calm. 20% of who presents with throat itchy & swelling that occurred shortly after her vaccination. Pt thinks it could be a panic attack. PE - unremarkable. Plan - home with monitoring.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,floxipro(anxiety)//isablume (birth control),no,no,,no,"['Conversion disorder', 'Crying', 'Panic attack', 'Pharyngeal swelling', 'Throat irritation']",UNK,PFIZER\BIONTECH,IM 931253,FL,78.0,F,"Rapid heart rate and pain in upper chest for about 15-20 minutes. Called 911, they gave two EKGs which appeared to be normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,"Lisinopril, Indapamide, Allopurinol, latanoprost - Multi vitamin, Vitamin D3, Lutein, Magnesium citrate",None,controlled high blood pressure,,none,"['Chest pain', 'Electrocardiogram normal', 'Heart rate increased']",1,PFIZER\BIONTECH,IM 931254,FL,62.0,F,"on 1/7/2021 day of vaccine, during the evening i began to feel flu like symptoms, Cognitive lethargy, all over lethargy, muscle pains, and chills.100.4 I had severe shaking and chills. I took 1/3 of percocet 7.5mg and went to bed. I shivered most of the night, sleeping in my clothes, which is not norm for me. I also had 3 blankets on. On 1/8/2021 I woke with fever of 100.4 and it receded to 99.8 during the day. Chills were diminshed greatly, moderate muscle pain all over . . I relaxed all day, slept. I sweated during the night requiring me to change once. On 1/9/2021 I woke with normal temp, still feeling lethargic, muscle pain. still present but less than yesterday. My cognitive clarity is better.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/01/2021,,PVT,Effexor 75 mg po daily.,Na,Depression Chronic Pain,,Penicillin Biaxin Bee and Wasp stings,"['Chills', 'Cognitive disorder', 'Hyperhidrosis', 'Influenza like illness', 'Lethargy', 'Myalgia', 'Night sweats', 'Pyrexia', 'Tremor']",1,MODERNA,IM 931255,CA,54.0,F,"Moderna COVID-19 Vaccine EUA - vaccine administered 12/31/20. mild injection site soreness 1/1/21 and 1/2/21. no events 1/3. On 1/4/21, developed temperature of 100.6 intermittently throughout the day. 1/5-1/8, no symptoms. Covid-19 test on 1/8 generated negative result. On 1/9/21, injection site red, warm to touch, itchy and swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,UNK,"Lisinopril, metformin, nora-b, lipitor",none,"high blood pressure, mild asthma",Whooping Cough vaccine resulted in 102 temp 1 day after vaccine,"allergy to sulfa, bee stings, star anise","['Body temperature increased', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Respiratory syncytial virus test negative', 'SARS-CoV-2 test negative']",1,MODERNA,IM 931256,IN,32.0,F,"I developed fever (102 F) chills, muscle aches, and extreme fatigue. The fever has subsided. The muscle aches and fatigue are still occurring. I did have a confirmed COVID infection in March 2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,Cetirizine 10 mg daily,None,None,,None,"['Chills', 'Fatigue', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 931257,IL,52.0,F,"Observed patient aggressively scratching arm. Occurred ~ 5 mins, lasted 30 mins. vitals/ lung sounds clear. administered 25mg Benadryl + 40mg Pepci AC patient left under own accord. 61 y/o female who presents with (L) arm itching shortly after her vaccine, no other symptoms. No significant Physical findings Probable localized allergic rxn.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,Flonase {Blood sugar,No,Diabetic & Hypertension,,aspirin/motrin/aleve,['Pruritus'],UNK,PFIZER\BIONTECH,IM 931258,IL,55.0,F,"2 inch area red and swollen around injection site, headache, fatigue, fever Tylenol and ibuprofen taken",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Fatigue', 'Injection site erythema', 'Injection site swelling', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931259,TX,23.0,M,"body aches after 4 hrs, fever of 102 the evening after the shot that lasted about 14 hrs, Now he has nausea, headache, vomiting, body aches. He was COVID-19 positive back in October.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,None,none,none,,Keflex,"['Headache', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 931260,NY,66.0,F,"Delayed local reaction at the site of the IM injection (1 week post vaccine). The left upper arm was hot, red, swollen and painful. The area was also very itchy. The size of the affected area was about 8 cm X 6 cm. This delayed local reaction lasted about 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,01/03/2021,7.0,PVT,metoprolol; amlodipine; aspirin; Vitamin D; atorvastatin; Prolia q 6 months,NONE,Microvascular coronary artery disease; osteoporosis,,NONE,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Skin reaction']",1,MODERNA,IM 931261,SC,26.0,F,"I had post nasal drip before I got the injection. because of the drip had a wet cough, then later day i started feeling tired. On Christmas eve i went to doctors care and they did a Covid test which was positive. Two weeks later i got an anti-body test.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,"Tylenol, Sudafed, Mucinex",none reported,none reported,,sulfa-based drugs,"['COVID-19', 'Fatigue', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 931262,IN,56.0,F,"Next day felt extremely tired, chills, sore throat, headache, body ache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,Synthetic Cytomel Chromium Phetermine,None,Fatigue,,Sulfa,"['Chills', 'Fatigue', 'Headache', 'Oropharyngeal pain', 'Pain']",2,PFIZER\BIONTECH,SYR 931263,TX,23.0,M,"Symptoms began Monday 21st- headache, body aches, injection site sore; couldn't taste or smell -went Emergency Room - Medical Center; was given Tylenol and ibuprofen and was given Covid Test - test result positive.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/20/2020,2.0,MIL,Doxycycline,no,no,,no,"['Ageusia', 'Anosmia', 'COVID-19', 'Headache', 'Influenza virus test', 'Injection site pain', 'Pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,SYR 931264,WV,47.0,F,"Patient had previously been diagnoses with COVID 19 in October 2020. She had a fairly serious case that nearly required hospitalization. The night after receiving vaccine, she had a reaction that she described as ""Like having COVID again."" She experience fatigue, fever (101.4), aches. Pain started in neck and worked its way down the body. Symptoms lasted approximately 16 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PHM,Unknown,None,Unknown,,No known allergies,"['Fatigue', 'Neck pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 931265,IN,47.0,M,"Fever of 101.5,chills,aches,headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,OTH,Lexapro 20mg Buspar 20mg once a day,,None,,Latex,"['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,MODERNA, 931266,AR,39.0,M,Sore arm at injection site & fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,SEN,None,Sinus infection,Diabetes,,Soy,"['Fatigue', 'Injection site pain']",1,MODERNA,IM 931267,OH,64.0,F,"headache, sore arm, fever, body aches, tiredness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,,none,copd,,none,"['Fatigue', 'Headache', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 931268,NY,23.0,F,"Approximately 2 hours after the vaccine, I developed severe pain to the injection site and arm. Inability to lift arm. I had severe night sweats that night, but no fever. Now it is day 3 post vaccine and I have a severe headache causing dizziness and nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,"Fluoxetine 20mg 1 tab PO QD. Organic Spearmint tea, 2 cups QD Berberine 1000mg QD Zinc 50mg QD Doxycycline HYC 100mg capsules BID",Moderate Cystic Acne,Polycystic Ovarian Syndrome,,none,"['Dizziness', 'Headache', 'Injected limb mobility decreased', 'Injection site pain', 'Nausea', 'Night sweats', 'Pain in extremity']",1,MODERNA,IM 931269,TX,26.0,F,"On Friday, January 8th, I started to feel pain/tenderness in my left armpit. It also felt firmer than my right armpit. I still feel pain/tenderness today, Saturday, January 9th. The pain is mild/moderate. I am still able to do my day-to-day activities. (I did not think it was vaccine related, so I did not make note of this during my v-safe daily check in.)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/08/2021,6.0,PUB,"1. Progesterone Micro 100mg (Two a night for 10 days, or until my period arrives. Whichever comes first.) 2. Pantoprazole 40mg (One pill every morning to help with acid reflux.)",None.,"PCOS, Pre-Diabetes, Obesity.",,None.,"['Axillary pain', 'Induration', 'Tenderness']",1,MODERNA,SYR 931270,IL,70.0,F,"patient feeling flushed & light headed. Onset occurred about 10 mins after vac Vitals monitored; no swelling throat/face. After calming patient, symptoms subsided. Called Dr. for release/review. 71 y/o female who presents with facial flushing & light headedness that began after her vaccination. No progression or other symptoms. Hx of similar RXN after exercise symptoms. P.E - Mild facial flushing started Possible mild allergic rxn. Plan - home with monitoring.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,No - just supplements,,,penicillin when teenager,"sulfa, ergotamie (migraines)","['Anxiety', 'Dizziness', 'Flushing']",UNK,PFIZER\BIONTECH,IM 931271,CA,35.0,F,"? After her shot in the afternoon, she sat outside for 15 minutes. She came back in and said her throat is warm and scratchy, and her left hand felt cold. ? I escorted her over to the ER and she was checked in. I then went right back to HD since we were so busy. ? Around 4pm in the afternoon after we closed HD, I went back to the ER. She was recovering and doing fine. Her ER nurse and patient did have a question about receiving the 2nd dose, and I provided the same answer that Dr provided to Dr about taking an Allegra 30 minutes before the second dose. ED Note: Patient presents with symptoms concerning for angioedema or anaphylaxis after immunization with Covid vaccine. Patient described a sensation of warmth and also later tingling in her throat which was treated aggressively with medication for this problem so as to prevent airway closure or further worsening symptoms. Patient was treated with IV fluid hydration along with H1 and H2 blockers, IV steroids and also subcutaneous epinephrine. On my reevaluation, her symptoms completely resolved with treatment. She was without other concerning findings on examination or by history and was without further angioedema or anaphylaxis after period of observation. She was discharged with prescription medication in good condition and asked to return should she have any further problems. Immpression: Angioedema, allergic reaction to vaccine, throat tingling, throat warmth MEDS in ED: Sodium Chloride 0.9% (Sodium Chloride 0.9% Bolus) 1,000 mL once IV Bolus, Reason for Infusion = Abnormal fluid losses diphenhydrAMINE (Benadryl) 25 mg = 0.5 mL once IV push methylPREDNISolone (SOLUMedrol) 125 mg = 2 mL once IV push famotidine (Pepcid) 20 mg = 2 mL once IV push EPINEPHrine 0.3 mg = 0.3 mL once intraMUSCULAR",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,PVT,none,none,none,,none,"['Angioedema', 'Feeling hot', 'Hypersensitivity', 'Peripheral coldness', 'Pharyngeal paraesthesia', 'Throat irritation']",1,PFIZER\BIONTECH,IM 931272,UT,47.0,F,"Dryness in mouth immediately as vaccine was being administered. Within 2-3 minutes mouth, tongue and throat started to swell. 50 mg of Benadryl was given. Started to feel better but 45 minutes later swelling started back up. Dryness in mouth still there and water couldn?t quench my thirst. Escorted to Emergency department. Epinephrine shot given 40mg of prednisone, 20 mg of Pepcid and 10 mg of Zyrtec given. Given another 20mg of prednisone, 10 mg of Pepcid and 10 mg of Zyrtec 1.5 hours later. Release after 4.5 hours. Given 3 days of medicine previously given. Swelling started back up 6 hours later so I took 50 mg of Benadryl. Swelling continued every 6-8 hours. Mouth was still really dry but as long as I drank 100 oz of water a day I was ok. Tuesday I had a small fever and very achy. Went to doctor and he prescribed 20 mg of prednisone twice daily tapering off for 11 days, 10 mg of Pepcid and Zyrtec twice daily for 11 more days. Finished my medicine Saturday January 2nd. I have been feeling better but still have swelling occasionally.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,"Zyrtec, Flonase, Tylenol, albuterol, symbicort and ibuprofen as needed.",None,Seasonal allergies,,All melons and blue cheese,"['Dry mouth', 'Pain', 'Pharyngeal swelling', 'Pyrexia', 'Swollen tongue', 'Thirst']",UNK,PFIZER\BIONTECH,IM 931273,IN,63.0,F,"Chills, body aches, headache, fever. Took OTC Tylenol for fever. Naproxen for body aches. Lasted about 12 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/07/2021,6.0,UNK,Over the counter vitamin B,None,None,,Keflex tolectin,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 931274,PA,41.0,F,"Oral dysaesthesia - scratchy throat morning after vaccination, then developed tongue burning and progresses to full mouth Fatigue, headache, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,WRK,Flonase,None,None,,None,"['Fatigue', 'Headache', 'Oral discomfort', 'Oral dysaesthesia', 'Pain', 'Scratch', 'Tongue discomfort']",1,PFIZER\BIONTECH,IM 931275,TX,35.0,F,"Dizziness, headache, feeling faint, nausea, vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Flagyl,,Crohns,,,"['Dizziness', 'Headache', 'Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH, 931276,CA,38.0,M,Vomit Diarrhea Fever Muscle aches Fatigue Shivering Headache Dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,OTH,None,Covid-19 prior not during time of vaccination. Negative test was December 21,None,,None,"['Chills', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia', 'Vomiting']",1,MODERNA,SYR 931277,IN,59.0,F,"Fever 100.3,body aches headache,tired",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Metoprolol,lisinopril ,venlafaxine,hydroclothoriazide,metformin xr,ibuprofen, omeprazole,vitamin b12 daily vitamin",None,"Diabetes,high blood pressure,",,Latex,"['Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 931278,WI,42.0,F,"The day of vaccine: sore left arm. Took Ibuprofen to be able to sleep. Woke up in the middle of the night with pain. The day after: moderate to severe pain on the left arm that radiates to the neck and back. Took Ibuprofen in the morning. Pain was getting better as the day pass. At night, around 6 pm started to feel that something is not OK. I am not the same as before. My legs are not very strong (feeling it, not a problem that I can?t walk - it feels like). Feeling dizzy at times. Went to bed and pain on the left arm is much better. Two days after the vaccine: woke up with body aches, feeling dizzy at times, weak, nauseous. Not feeling OK. It is now around11:30 am two day after the vaccine and I am starting to get worried. Please contact me for advise. Thanks",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,"Vitamine D, citrucel, complex B, birth control",None,None,,"NKA, NKDA","['Asthenia', 'Back pain', 'Dizziness', 'Malaise', 'Muscular weakness', 'Nausea', 'Neck pain', 'Pain', 'Pain in extremity', 'Sleep disorder']",UNK,PFIZER\BIONTECH,UN 931279,AL,26.0,F,"Sore arm, entire muscle is very sore, very hard to lift arm. Painful to the touch and painful just went not using. Arm feels very heavy, hard to lift and use at all. Around 4 am, started being nauseas, having stomach cramps, diarrhea, and vomiting. This continued throughout the night and finally calmed down to just stomach pains around 11am.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,OTH,"Zyrtec, symbicort (inhaler)",,Asthma,,,"['Abdominal pain upper', 'Diarrhoea', 'Limb discomfort', 'Mobility decreased', 'Myalgia', 'Nausea', 'Pain in extremity', 'Tenderness', 'Vomiting']",1,MODERNA,IM 931280,,45.0,F,"pt c/o sore throat and feeling of anxiety; she sat down on a cot for about 20 minutes, offered water and she refused; 02 sat measured 99% on RA; eventually she said she felt better and left, she mentioned that she has benadryl in her car that she'll take if needed",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,UNK,,,,,,"['Anxiety', 'Oropharyngeal pain']",1,MODERNA,IM 931281,NY,66.0,F,"Sharp, painful muscle cramps in both left and right feet and ankles, relieved by self-administered massage. Cramping began when first lying down in bed, relieved by massage, then recurred about 20 minutes after falling asleep, and again relieved by self-administered massage. Not persistent. Did not recur after being relieved by self-administered massage the second time. I was physically exhausted due to only 3 hours sleep the night before, so this may have been the result of exhaustion and not the vaccine, but has never happened before and seemed severe enough to file a report about it. My arm was not particularly sore where vaccine administered and no other SE.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,"Olmesartan, plavix, rosuvastatin, buspirone, levocetirizine, gabapentin, vit C, Vit D, glucosamine Chondroitin mix, EPA,",none,Managed hypertension,,none,"['Fatigue', 'Muscle spasms', 'Pain in extremity']",1,MODERNA,IM 931282,LA,30.0,M,"Severe pain in arm that was injected, it started 3 hours after vaccine and progressively got worse to the point where it hurts to use the arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,MIL,None,None,None,,None,"['Pain', 'Pain in extremity']",1,MODERNA,SYR 931283,,23.0,F,"pt c/o feeling lightheaded, dizzy, faint; she was escorted to a cot to lie down for several minutes, she used an ice pack on her head and neck; she never lost consciousness; she eventually stated that she felt better and left the premises on her own",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,UNK,,,,,,"['Dizziness', 'Syncope']",1,MODERNA,IM 931284,AZ,48.0,F,low grade fever/chills/weakness/body aches/extreme tiredness Treated with Ibuprofen 600mg once - relief from chills/fever/body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,Enalapril-HCTZ 5-12.5mg x1 tab daily Zinc 50mg x1 tab daily Cranberry softgels x2 tabs daily Vitamin D3 50mcg x1 tab daily Fish Oil Softgels 1000mg x2 tabs daily,None,HTN,,Neosporin Ointment,"['Asthenia', 'Chills', 'Fatigue', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 931285,VA,50.0,F,"Swelling and pain under arms - no treatment (seemed to mostly subside when Celebrex was taken) Spot on tongue-no treatment still visible but no pain or irritation Other symptoms were expected and include injection site pain, heat rash likely from fever during the night but never had a recorded fever-subsided through day, fatigue, mild headache, overall just feeling like I was fighting a cold. (Viewed as immune response to me)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/08/2021,2.0,PVT,"Celebrex, toprol xl, Effexor XR, Vit D, Calcium, MVI",None Thought I had eye infection but may have been severe dry eyes. Uncertain. Briefly on eye drops.,Non radiologic spondyloarthropathy/ankylosing spondylitis gene Anxiety High Blood pressure,,Erythromycin causes gi pain and vomiting,"['Fatigue', 'Headache', 'Influenza like illness', 'Injection site pain', 'Lymph node pain', 'Lymphadenopathy', 'Miliaria', 'Pyrexia', 'Tongue ulceration']",2,PFIZER\BIONTECH,IM 931286,MA,57.0,F,"I am a physician and I got dose 2 at 1:30pm on Jan 4. Next afternoon, Jan 5, I got severe myalgias, fever up to 100, severe fatigue, went home after work and slept til the next morning, went to work, took ibuprofen, and the myalgias improved and felt better. But around 3 pm, Jan 6, I got mild vertigo. By about 7pm Jan 6, I noticed my L ear didn't hear well. I changed the battery in my hearing aide and cleaned it but It made no difference. I woke up on Jan 7 with severe vertigo and hearing loss. I did Epley's maneuvers with no effect. I have had similar episodes. I went to work, but gave up when I could not hear patients talking to me. I went to the Emergency Dept and got admitted. I was too unsteady on my feet. Audiogram showed profound hearing loss both ears and almost complete loss of discrmination in R ear. I was put on high dose steroids. Also having tinnitus (mostly whooshing sound of my own pulse). MRI negative. Blood work negative. Some mild improvement now, after 1 dose steroids.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/04/2020,01/05/2021,367.0,PVT,"Topiramate, Nortriptline, ibuprofen, Excedrin migraine, Zolmitriptan, Estrace cream",none,"History of Graves disease, history of episodic vertigo with hearing loss thought to be due to inflammatory hair cell disease",,"Sulfa, SSRI","['Audiogram abnormal', 'Auditory disorder', 'Balance disorder', 'Blood test normal', 'Deafness', 'Deafness bilateral', 'Electrocardiogram normal', 'Fatigue', 'Magnetic resonance imaging brain normal', 'Myalgia', 'Pyrexia', 'Tinnitus', 'Vertigo']",2,PFIZER\BIONTECH,IM 931287,CA,41.0,M,"Low grade fever (100 deg F), body ache, chills and some dry cough. Lasted for a day. Took over the counter tylenol and woke up feeling better next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Cough', 'Pain', 'Pyrexia']",1,MODERNA,SYR 931288,IN,33.0,M,"Fever to 102, severe body aches, nausea and headache for 48 hours Responded well to Tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,UNK,None,None,None,,None,"['Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931289,MI,29.0,F,"Client reported that on 12/30/2020 noted dime size red area around injection site then on 12/31/2020 noted golf ball size now was itchy and warm to touch then reported went away. On 1/5/2021 woke up with a red and swollen, hard area in same area that was itching and warm to touch. On 1/6/2021 Contacted Urgent Care and was seen and given Bactrim x10 days and instructed could put ice pack on area and to not receive dose #2. On 1/7/2021 noted area now looked like ""bulls eye"" reporting red in middle then white then red ring around it. Reports on 1/8/2021 area has faded, still see some redness with red border but no ""bulls eye."" Denied ever running a fever, having pain or overall ill feeling. Is currently on 10 days of Bactrim and Ibuprofen 600mg 3xdx2 days as directed by Medical Director. Client did take Benadryl on 1/6/2021 to help with itching and reported ""it did help."" Client will continue to follow up with her PCP at Medical Clinic as needed. No other issues reported at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,PUB,unknown,None Known or reported,History of Hodgkins Lymphoma 2013,,None Known or reported,"['Injection site discolouration', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 931290,FL,38.0,F,"Injection site is red, swollen, very itchy. Redness has spread a bit swelling is getting better. This occurred 7 days post vaccine. Currently just monitoring.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/08/2021,6.0,WRK,Hydroxychloroquine One a day vitamin Zyrtec,,,,Sulfa,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA,SYR 931291,TN,45.0,F,"Sore arm and low-grade headache for 3-4 days. Day 1, approx 4 hours after Pfizer dose 1, got headache. Took Aleve, headache gone. Day 2 at 1am, woke up with pretty bad arm pain (""why does my arm hurt so bad? Have I lifted too much weight at the gym?"") and headache Did nothing; went back to sleep. Day 3, took Aleve again in the evening; headache gone. Day 4, mild headache. Day 5 and on, feeling fine. On Jan 5, for 4 days straight, I fell asleep at 6 and 7 pm. Normally I go to bed at 9am ( I get up at 4am). Felt fine enough to work, just tired at night more than usual. My 2nd dose is scheduled Jan 15 at noon.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"Levothyroxine 50mcg daily Atorvastatin 10mg daily Vitamin D3 5000 IU daily Doctors Best Folate, 800mcg daily Emergen-C packets (1000 mg of Vitamin C plus B-complex and mulitvitamin)",None,"Hypothyroidism, hyperlipidemia, dysfunctional uterine bleeding, primary infertility",,"Ciprofloxacin, Erthromycin (vomiting) Oxycodone (itching)","['Headache', 'Pain in extremity']",1,PFIZER\BIONTECH,SC 931292,TN,40.0,F,Swollen left tonsillar lymph node and left sore throat,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/07/2021,5.0,OTH,"Lexapro 10mg Zinc, Vitamin D, pre/probiotic, multivitamin, collagen, hyaluronic acid","Runny nose symptoms, exposed to covid from family member and quarantined appropriately; however, never tested",none,,nuts,"['Lymphadenopathy', 'Oropharyngeal pain']",1,PFIZER\BIONTECH,IM 931293,NJ,59.0,M,"Approximately 3 minutes after the injection I began to experience palpitations and felt flushed. My heart rate increased from about 70 to 110. This lasted for approximately 5 minutes and then recurred about 10 minutes later. After the second event I took Benadryl 50mg po. I experienced palpitations and felt flush a third time about 5 minutes after taking Benadryl lasting about 2 minutes. Approximately 40 minutes after the injection I began to feel cold and clammy, this lasted about 35 minutes. My pulse was about 75 and BP 140/90 during this last event. Approximately 90 minutes after the injection I went home and experienced intermittent chills for a few hours then I was asymptotic.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PHM,Toprol XL 50mg qd,,PVC's,,IV Contrast Shellfish,"['Chills', 'Cold sweat', 'Feeling cold', 'Flushing', 'Heart rate increased', 'Palpitations']",1,MODERNA,SYR 931294,IN,59.0,F,Itching all over,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,"Previcid, Metformin, pepcid, Jardiance",None,"Diabetes, HTN",,Tetracycline,['Pruritus'],1,MODERNA,IM 931295,FL,37.0,F,"After a few minutes of administration, I felt tingling down my right arm, my right side of the face, and my tongue. My eye started to hurt with pressure. The tingling in my arm and hand went away after 30 minutes or so but there was still some tingling of my face, toungue and the pressure of the eye still remained. That night I took a Zyrtec and felt better for a few days. on 1/8 I started to feel tinging in my tongue and pressure in my right eye again. I took Zyrtec that night and it went away. Currently this morning I feel okay and hope it wont come back.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,PHM,"Vitamin B Stress Complex, Vitamin D3 1000units",Had Headaches previously,None,,None,"['Injection site paraesthesia', 'Intraocular pressure test', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 931296,OH,39.0,F,"Swelling, itching, warmth, redness at injection site started at day 8 and spread through day 12 s/p vaccine (today). No fever or chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,PVT,"Zyrtec, levoxyl, metformin, singulair, protonix, spironolactone, Benadryl, ozempic, b12",None,"Asthma, celiac, gerd, pcos, hypothyroidism, insulin resistant, gastro paresis, b12 deficiency, NADPH deficiency",,"Venofer, imitrex","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SC 931297,CA,31.0,M,Fever (101.2) Nausea Muscle and Joint aches Lethargic,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,MIL,Max Muscle Whey Isolate/casein powder,Contracted COVID-19 w/symptoms and tested positive on 5 Dec 2020.,N/a,,N/a,"['Arthralgia', 'Lethargy', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,SYR 931298,NY,43.0,F,"tongue tingling, hot flashes, sweating, tachycardia, hypertension. improved after benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PVT,"synthroid, lexapro",none,hypothyroidism,,shellfish,"['Full blood count normal', 'Hot flush', 'Hyperhidrosis', 'Hypertension', 'Metabolic function test', 'Paraesthesia oral', 'Tachycardia', 'Tryptase']",UNK,MODERNA, 931299,MN,47.0,F,"About 36 hours after vaccination, I experienced incredible ""brain"" fatigue/fog. My physical body did not seem affected by the fatigue but my brain/head felt very ""fuzzy"". I had a hard time getting words out. Similar feeling to etoh intoxication. I was a bit off balance and dizzy. I remember shaking my head to try to clear it. I also had a very""plastic"" taste in my mouth and felt nauseous. At the 48 hour mark (almost exactly) I felt better. At 60 hour mark brain/head symptoms completely resolved. Only experienced a very slight nauseated feeling.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/08/2021,2.0,PVT,,,Osteoarthritis in left knee Bilateral Optic Neuritis,,KNDA,"['Balance disorder', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Nausea', 'Speech disorder', 'Taste disorder']",1,PFIZER\BIONTECH,IM 931300,IL,59.0,F,"Pt reported onset of ""quivering"" lips & Headache 15 min after vaccine. Vitals recorded. MD contacted & interviewed (Dr.) patient. Ambulance called. Vitals re checked Benadryl 25 mg PO given. Paramedic & Ambulance arrive 4:35 59 y/o who states she had anaphylaxis before her symptoms started the same as today. C/o quivering lips & H/A No rash or respiratory comp (EMT's exam - normal except ? movement. Assessment - Possible allergic RXN Plan - Ambulance transport to ED",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,,,PUB,Humira for spondylitis,,"Hx Diabetes Type II, Spondylitis, High BP",,Allergic: Shellfish,"['Headache', 'Tremor']",UNK,PFIZER\BIONTECH,IM 931301,NY,46.0,M,"- pt came into the clinic after being vaccinated 24 hours ago at another facility with fever, body aches and lost of tase",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,PVT,denies,denies,denies,,denies,"['Ageusia', 'Pain', 'Pyrexia']",UNK,MODERNA, 931302,NY,41.0,F,"Few minutes after injection - unusual taste in the mouth and sense of palpitation About 8 hours after - rash on the back of both hands, not itchy, lacy faint rash rapidly spreading limited to the hands, associated with tingling and paresthesia on both palms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,Levothyroxine,Breastfeeding,"Hypothyroidism, compensated",,None,"['Palpitations', 'Paraesthesia', 'Rash', 'Taste disorder']",1,MODERNA,IM 931304,CA,35.0,F,"Employee reported 2 episodes where she felt she had an elevated heart rate. Vital Signs: 139/94 HR 81, O2 Sat 98% Observed employee x 30 minutes. At report of second episode, employee sent to ER. Patient reports cleared by ER physician, condition stable, no further episodes of elevated heart rate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,,,,,"At time of vaccination, employee stated no allergies. After report of reaction, employee stated new allergy to nuts and sunflower seeds. Also states allergy to Sulfa class medications.",['Heart rate increased'],1,PFIZER\BIONTECH,IM 931305,OR,50.0,F,"Pain at infection sit, swelling, large lump, hot. Concerned that side effects have not gone away. Injection site is still hot, swollen and now itches but doesn?t hurt.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,UNK,"Cozaar, vit d, vit c, calcium, multi vit",Na,Na,,Sulfa,"['Injection site mass', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 931306,TX,24.0,F,"Starting at 4am the following morning of vaccine, sweats, aching arm at injection site(no pain prior), sore throat on right side when swallowing(possibly swollen right lymph node), sore muscles including neck,shoulders and back, headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,UNK,"Adderall, lexapro",,Asthma,,Penicillin,"['Arthralgia', 'Back pain', 'Dysphagia', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Myalgia', 'Neck pain', 'Oropharyngeal pain']",2,PFIZER\BIONTECH,IM 931307,MO,70.0,M,"Severe weakness and fatigue, headaches and ""cloudy"" . Severe gastritis. Unable to perform normal duties as a dentist.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"Amlodipine, omeprozole",,"mild high blood pressure, chronic pain from spinal stenosis,",Tetanus,"tetanus, clindamycin","['Asthenia', 'Fatigue', 'Feeling abnormal', 'Gastritis', 'Headache', 'Impaired work ability', 'Laboratory test normal']",1,MODERNA,IM 931308,,46.0,M,- fever - bodyaches - lost of taste and smell - positive rapid covid 19 test,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Ageusia', 'Anosmia', 'COVID-19', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,MODERNA, 931309,OR,41.0,F,"employee received the vaccine at 3:45 PM, and at 4:00 PM began feeling a sensation in her mouth of having lots of saliva. Did not get nauseated. Also experienced metallic taste in mouth. 5 minutes later felt dizzy, then 5 minutes later felt shaky BP was 159/93, HR 107 felt well enough to finish out shift, and went home. Following day felt lethargic, but recovered from that at home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Dizziness', 'Dysgeusia', 'Lethargy', 'Nervousness', 'Salivary hypersecretion']",1,PFIZER\BIONTECH,IM 931310,CA,32.0,F,"Extreme arm pain at site of injection (couldn?t raise arm). Body aches, slight fever overnight.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,Sertraline 50,None,,,None,"['Injection site pain', 'Joint range of motion decreased', 'Pain', 'Pyrexia']",1,MODERNA,IM 931311,SC,25.0,M,"Hot flashes, chills, cold like symptoms, some elevated heart rate, injection site warm to the touch, red ring around injection sight the size of two quarters length wise, was feeling foggy headed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,SEN,"Tylenol, Vitamin D, Mens 1 a day Vitamin, Benadryl",None,"Blind, left eye injury",,None,"['Chills', 'Feeling abnormal', 'Heart rate increased', 'Hot flush', 'Injection site erythema', 'Injection site warmth', 'Nasopharyngitis']",1,MODERNA,SYR 931312,IL,39.0,M,"Left knee pain and stiffness 1/7 which is resolving, right knee pain and severe stiffness as of yesterday. Hard to bend leg.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,01/07/2021,20.0,PVT,,,,,,"['Arthralgia', 'Joint stiffness', 'Mobility decreased']",1,PFIZER\BIONTECH,IM 931314,NV,62.0,F,"THE NEXT DAY I FEEL TOOO BAD I HAVE HIGH FIVER, BODI PAIN, HEADACHE, NECK PAIN , AND TOO COOL I TAKE TYLENOL AND AVIL EVERY 4 HOURS I DONT GO TO THE HOSPITAL BECAUSE I SCARE",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,OTH,none,,SINUS,,none,"['Fear', 'Feeling abnormal', 'Feeling cold', 'Headache', 'Neck pain', 'Pain', 'Pyrexia']",1,MODERNA, 931315,WA,44.0,F,"Latent edema, urticaria and erythema in injection seem one week prior that was new",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,UNK,None,None,None,,Macrodantin and latex,"['Injection site erythema', 'Injection site oedema', 'Injection site urticaria']",1,MODERNA,SYR 931316,NV,28.0,F,"Exactly one week later, bumpy redness/rash, itchiness, swelling and tenderness right below injection site. Left upper and forearm started hurting 5 hours after initial symptom was noticed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,PVT,Acetaminophen 1000 mg Aleve 220 mg Taken 8 hours apart as a prophylactic measure.,None,None,,No known allergies,"['Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Rash erythematous']",1,MODERNA,IM 931317,IN,47.0,F,"Chills, low grade fever to start at 98.1, full body aches, fatigue, temperature rose to 101.1 then about 9:00 pm fever broke and back down to 98.0 and felt fine ever since.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PUB,"Enzyme, probiotic, b12, CBD 1000mcg",None,None,,None,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 931318,FL,81.0,F,"On Jan 7, 2021 I developed a low fever (100.1), chills, scratchy throat, stuffy nose, and headache. On Jan 8, I was tested positive for Covid with the quick result test. Fever and headache are now gone, but I continue to have scratchy throat and nasal congestion. No medical treatment sought but I am now quarantined for 2 weeks.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/07/2021,5.0,UNK,Primidone Solifenacin,none,none,,none,"['COVID-19', 'Chills', 'Headache', 'Nasal congestion', 'Oropharyngeal discomfort', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 931319,FL,57.0,F,"Pain redness and swelling at injection site. Redness about the size of a baseball. Pain and swelling went away on day 4 On Day 6 swelling and redness came back with itchy sensation, area the size of a baseball. Redness and swelling continued to grow and still exists at day 9. It is now the size of my hand, fingertips to my wrist. Taking benedryl and using hydrocortisone cream. Redness is fading on the inside of the area, but continuing to spread on the outer edges. I have concerns about getting the second shot. I am due to get it Jan 28",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,Multi vitamin Rosuvastatin 10mg Levothyroxine 88 mcg Venlafaxine 225 mg,None,Hashimoto Hypothyroid,,Bactrim Bee venom Fish,"['Erythema', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 931322,KS,36.0,F,"Severe migraine occurred within 2 days of taking vaccine and lasted three days (rescue migraine medication Rizatriptan did not help). Also began experiencing vivid nightmares. Never experienced vivid nightmares before receiving Moderna vaccine. Vivid nightmares occurring nightly and including racing heart beat, sweating, shaking and ridged muscles, taking 1-2 hours to fall back asleep, continuing to increase in intensity.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,"Nortriptyline, Robaxin",None,Migraines and asthma,,None,"['Condition aggravated', 'Heart rate increased', 'Hyperhidrosis', 'Initial insomnia', 'Migraine', 'Muscle rigidity', 'Nightmare', 'Tremor']",1,MODERNA,SYR 931323,OH,28.0,M,"Supraclavicular lymph node (mobile, initially mildly tender, 1-2cm, soft) occurring on left side (same side as the vaccine). This was first noted 2 days after vaccination. Associated symptoms including tenderness at the left deltoid (injection site). No fevers, fatigue, night sweats noted.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,None,None,None,,None,"['Full blood count normal', 'Injection site pain', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 931324,MI,28.0,M,"Myalgia's, Fatigue, Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,WRK,None,None,None,Pertussis,None,"['Chills', 'Fatigue', 'Myalgia']",2,PFIZER\BIONTECH,IM 931325,MA,45.0,F,Patient reported increased fatigue a few hours after receiving first dose. Fatigue worsened over the next couple of days and had a couple episodes of vomiting. Consulted with PCP and advised to monitor over next couple of days. Symptoms resolved by 1/8.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SCH,Unknown,Unknown,Unknown,,No known allergies,"['Fatigue', 'Vomiting']",1,MODERNA,IM 931326,,57.0,F,"Patient reported feeling itchy during 15 min observation, nothing noted on skin. Resolved at end of obs period.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,,,,,,['Pruritus'],2,PFIZER\BIONTECH,IM 931327,TX,37.0,F,EMPLOYEE HAD RECEIVED FIRST DOSE OF PFIZER VACCINE ON 12/9/2020. PRESENTED TO CLINIC AND WAS VACCINATED WITH MODERNA FIRST DOSE ON 1/8/2021. EMPLOYEE ADMITTED SHE CIRCUMVENTED THE REGISTRATION PROCESS BECAUSE SHE DID NOT WANT TO DRIVE TO THE ORIGINAL LOCATION NOT REALIZING THIS WAS A DIFFERENT VACCINE. MONITORED FOR A 30 MINUTE PERIOD AND WAS RELEASED.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PVT,,,,,NKDA,['Interchange of vaccine products'],UNK,MODERNA,IM 931328,IL,55.0,F,1/08 12pm- Diarrhea 11pm- Nausea throughout the night 1/09 6am- Vertigo,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,Prempro Protonix Singulair,None,GERD,,None,"['Diarrhoea', 'Nausea', 'Vertigo']",2,PFIZER\BIONTECH,IM 931329,,59.0,F,12 noon Jan. 9/2021- feeling achey all over- feels like I'm coming down with something.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PUB,"D, C, probiotics, Zn, CoQ10, montelukast, incruse, qvar, rosuvastatin, lexapro, omeprazole, diltiazem",None,Asthma,Sore arm and achey body,Sulfa,['Pain'],2,MODERNA,IM 931330,OR,47.0,F,employee received the vaccine 12/31/2020. 15 minutes later she stated she felt very sleepy. Stated it was hard to keep her eyes open. She was observed for 30 minutes and sent home. Telephone calls to her during the day indicate she felt sleepy until late afternoon. She stated she felt sleepy for the rest of the afternoon. She stated she woke next day feeling fine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,['Somnolence'],UNK,PFIZER\BIONTECH, 931331,NJ,59.0,F,Developed fever/chills next day and following day which resolved but also began having having purple/blue fingertips - both pads and nails - when my hands are cold. This began on day after vaccine and continues to date.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/22/2020,1.0,PVT,,none,rosacea reactive airway (seasonal),after Tetanus - sore arm for a few days.,none,"['Chills', 'Nail discolouration', 'Peripheral coldness', 'Pyrexia', 'Skin discolouration']",1,PFIZER\BIONTECH,IM 931332,PR,53.0,F,PATIENT REFERS STRONG HEADACHE AND INSOMNIA BECAUSE OF THE HEADACHE,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/08/2021,4.0,PHM,NOT KNOWN,UNKNOWN,UNKNOWN,,UNKNOWN,"['Headache', 'Insomnia']",1,"SEQIRUS, INC.",IM 931333,OH,30.0,F,Red rash and swelling medial and distal slightly to injection site. noted symptoms one week after injection of vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/07/2021,7.0,UNK,birth control. Zoloft,,,,,"['Injection site reaction', 'Injection site swelling', 'Rash erythematous']",UNK,MODERNA,IM 931334,NY,56.0,F,"1/5/21 itching of left arm pit, soreness of arm 3cms below injection 1/6/21 bruise noted at the site of soreness previously (not the injection) rash on the arm below bruise 1/7/21 seen by employee health, rash slightly warmer, 1% hydrocortisone applied to rash 1/8/21 no change except rash is not warm, hydrocortisone applied 1/9/21 rash extended down the arm toward the elbow, bruise lightening, hydrocortisone applied",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,"Synthroid, aspirin, Wellbutrin, vitamin D, fish oil, eye vitamin, famotidine, tension headache relief, turmeric, vitamin C",,"Hypothyroidism, depression, elevated cholesterol",,NKDA,"['Injection site bruising', 'Injection site pain', 'Injection site rash', 'Injection site warmth', 'Pruritus']",1,MODERNA,IM 931335,ME,49.0,F,Developed pruritic annular raised erythematous with central clearing rash at injection site about 10 days after injection received.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/08/2021,10.0,PVT,None,None,None,,None,"['Injection site reaction', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",1,MODERNA,IM 931336,ID,20.0,M,"Side effects manifested after second dose as a migrane in the early morning (~4:30 AM). Migrane persisted for the next hour before the pain noticable dissappated; completely clear by 8:00 AM. Nasal congestion arose for a brief moment at approximately 6:30 AM but did not persist for longer than ten minutes. If relevant: I attended a gym (crossfit) session at 6:15 PM on 01/08/2021 which lead to deeper breathing, elevated heart rate, and major sweating. No side effects appeared to manifest at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Citalopram Hydrobromide (20mg),None,None,,None,"['Heart rate increased', 'Hyperhidrosis', 'Hyperventilation', 'Migraine', 'Nasal congestion']",2,PFIZER\BIONTECH,IM 931337,OR,37.0,M,"States 15 minutes after vaccine, he felt a lump deep in throat at the level of sternum. Also felt light headed and short of breath. He felt like his tongue was a little swollen. Was taken to ER for further evaluation & treatment Felt better later same day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,,,,,,"['Dizziness', 'Dyspnoea', 'Sensation of foreign body', 'Swollen tongue']",UNK,PFIZER\BIONTECH, 931338,AR,26.0,F,Severe headache Dizziness Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,Metoprolol 12.5mg Aspirin 81mg vyfemla,None,Occasional tachycardia,,None,"['Dizziness', 'Fatigue', 'Headache']",2,PFIZER\BIONTECH,IM 931339,IL,55.0,M,Patient fainted and experienced a hard time breathing for 10 mins. Vital signs: BP: uncooperative HR: 110 RR: 24 O2: 90% and Temp: 97.5. He received 3 Ls of oxygen and 911 was called. He was sent to the ER.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/09/2021,2.0,PHM,"At 8 am, he got Meloxicam 7.5 mg tab, Ezetimibe 10 mg tab, Levothyroxine 25 mcg tab, Senna Laxative 8.6 mg 2 tabs, Vitamin D3 1,000 IU 2 tabs, Lactulose 10gm/15ml soln 30 mLs, and Acetaminophen 325 mg 2 tabs.",None.,"Profound intellectual disability, Down Syndrome, and Hyperlipidemia.",,No known allergies.,"['Dyspnoea', 'Syncope']",1,MODERNA,IM 931340,MA,26.0,F,"Patient reported feeling fine after 15 minute observation post vaccination. She returned immediately after being cleared stating she felt sweaty, hot, and dizzy. Was given Gatorade and immediately transferred to health services. She was released an hour later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,SCH,Unknown,No illness at time of vaccine,Unknown,,No known allergies,"['Dizziness', 'Feeling hot', 'Hyperhidrosis']",1,MODERNA,IM 931341,,56.0,F,"Patient reported headache shortly after admin, resolved at end of 15 min obs period.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,,,,,,"['Headache', 'Immediate post-injection reaction']",2,PFIZER\BIONTECH,IM 931342,IL,30.0,F,Dizziness.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,WRK,Levothyroxine 88 mcg,No,Hypothyroidism,,No,['Dizziness'],1,MODERNA,IM 931343,OR,49.0,M,"employee received Pfizer Covid vaccine 12/28/20 afternoon 2:30 PM at 2:45 PM, he began feeling ""odd"". States he felt chilled, but no fever states he ""could not warm up"" Whole body felt bad had 2 to 3 hour episode of diarrhea symptoms lasted 2 days, then he felt better",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Chills', 'Diarrhoea', 'Feeling abnormal', 'Malaise']",UNK,PFIZER\BIONTECH, 931344,TX,30.0,F,"Neck pain, chills, high fever, joint pain for 72hrs nausea, abd. cramping (48 hrs post vaccine) persistent symptoms lasting 5 days after COVID vaccine Cervical & submandibular lymph adenopathy",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2020,01/05/2020,1.0,WRK,none,none,none,,none,"['Abdominal pain', 'Arthralgia', 'Chills', 'Computerised tomogram abdomen', 'Laboratory test', 'Lymphadenopathy', 'Nausea', 'Neck pain', 'Pyrexia', 'Urine analysis']",2,PFIZER\BIONTECH,IM 931345,TX,46.0,F,"Warmth, itching & redness at (R) deltoid vaccine site. onset 6 days after injection. Pepcid 20mg PO daily Loratidine 10mg PO daily doxycycline 100mg PO BID x 10day",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/06/2021,6.0,WRK,Ozempic weekly 25,None,None,Same reaction to flu shot in the past,NKDA,"['Injection site erythema', 'Injection site pruritus', 'Vaccination site warmth']",1,MODERNA,IM 931346,TX,37.0,F,"redness, swelling + itching to site within hours of recieving vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,"Allegra, Nyquil PRN, Tylenol PRN, Advil, Mul PR",,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 931347,WI,83.0,F,Burning in back of hands that has lightened up by time of notification (1745),Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,SEN,,,Patient had COVID-19 in October 2020,,"Atorvastatin, Azithromycin, Codeine, Ibuprofen, Iodine, Levofloxacin, Penicillins, sulfa antibiotics",['Burning sensation'],1,MODERNA,IM 931348,CT,55.0,F,"Patient felt tongue swell, and then her throat started to close. -Anaphylaxis",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,SEN,not Known,not Known,not Know,,none,"['Anaphylactic reaction', 'Swollen tongue', 'Throat tightness']",1,PFIZER\BIONTECH,IM 931349,,43.0,F,"I recievwd my 2nd dose of Pfizer Covid vaccine on 01/06/2021. I started feeling sick on 01/07/2021 early morning. I had a fever (ranging between 99.7 to 100.1), had chills, bodyache, and a headache. I did not have the strength to get out of bed all day (on 01/07/2021). Today my symptoms have improved to some extent but I still have a bodyache and headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,OTH,none,no,no,,none,"['Chills', 'Headache', 'Malaise', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931350,IA,68.0,F,Daughter called 30 Min after patient left facility (about 1 hr after vaccine) reporting Left side of her face was numb and tingling but was easing. MD previously approved vaccination. Patient's daughter was instructed to monitor patient and call MD if symptoms worse.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,OTH,No records,,"Guillain-Barre syndrome, heart disease",,,"['Hypoaesthesia', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 931351,NY,,F,"Patient stated, headache, muscle stiffness, nausea, accompanied by an unbearable migraine occurred approx. 24 hours post vaccination. Pt took Tyelenol which relieved the muscle pain, rehydrated self to minimize symptoms fr. migraine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Lisinopril, for HTN increased",,Hypertension,,iodine,"['Headache', 'Migraine', 'Musculoskeletal stiffness', 'Myalgia', 'Nausea']",1,MODERNA,IM 931352,CA,31.0,F,"(L) arm swollen, red, Hot to the touch, sore at the site of injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,PVT,,,,,NKDA,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 931353,WI,42.0,F,"The patient developed a raised linear pattern of hives on her left forearm - measuring approx. 2 1/2"" in length with erythema along with an area of raised erythema close to her left wrist - palmar Aspect. Received Benadryl 25 mg syrup po at 1427. Vitals at 1438 = P 125, B/P 195/119, O2 Sat 99% on RA. At 1438 patient noted with Raised linear hive with surrounding erythema approx 3/4"" long above (L) eyebrow. Given Benadryl 25mg syrup po. at 1438. Vitals repeated At 14:35 patient assessed. No swelling noted of lips, tongue or elsewhere in mouth. Talking without difficulty. Swallowing + breathing without problem. Cardiac - S1S2 RRR. 0 murmurs noted. Chest - CTA Bilat + NL. vitals repeated at 1445 and B/P 179/116, HR - 63, O2 sat 98% on RA. vitals repeated at 1500 and B/P 167/100, HR 64, O2 sat 98% on RA. Patient reporting B/P at Baseline. By 1500 on 1/8/2021 All raised erythematous areas above Right eyebrow, on left wrist + Left forearm resolved. Patient reporting to feeling better. vitals repeated @ 1525 and B/P 175/103, HR 52 and O2 sat 95% on RA. Patient remains Asymptomatic, no new hives or red patches noted. Breathing without difficulty. No swelling of lips, tongue or elsewhere in mouth observed. Answering questions appropriately. Patient met with unit supervisor and given the ""ok"" to return to unit. It was explained to patient that should her symptoms return to notify unit nursing staff + seek medical care.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,"Synthroid, Lisinopril, Amlodipine",Denies,Hypertension + Graves disease,,"Adhesive sensitivity, Reaction to Depo shot","['Erythema', 'Erythema multiforme', 'Urticaria']",1,MODERNA,IM 931354,CT,,F,Pt with c/o lightheadedness and burning sensation in chest 5 minutes post vaccination. Assisted to stretcher bed. BP 110/67 HR 85 RR 20 O2 sat 99% on room air. Water & electrolytes given for hydration. Pt stated burning sensation resolved prior to discharge and lightheadedness minimal. Ambulation on unit with no c/o. Discharged at 11:15 AM,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Lipitor 10mg qd, Pilocarpine 5mg BID, VESI 10mg qd",None,"hyperlipidemia, overactive bladder, dry mouth/dry eyes",,Latex - hives,"['Chest pain', 'Dizziness']",1,MODERNA,IM 931355,VA,64.0,F,"Client felt dizzy + lightheaded, hot flash. Became pale + diaphoRetic. Reported feeling anxious about COVID, the vaccine, potential side effects, everything. Patient was in post vaccine holding area being monitored by an RN for mandatory 15 minute wait time. Was able to ambulate w/assist to treatment area. Placed in Room w/RN. Placed supine on bed. BP 136/85 HR 71 Regular, Resp 18 Regular. Pt pale, talkative. Given apple jc on Request. Tol. well. Slowly returned to normal skin color. Symptoms Resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,"Vit. D, Bio-identical estRogen /PRogenbn replacement, Adrenal BoosteR, baby Aspirin","""normal seasonal Allergies",seasonal allergies,,NKDA Allergic mold.,"['Anxiety', 'Dizziness', 'Hot flush', 'Hyperhidrosis', 'Pallor']",1,MODERNA,IM 931356,OH,64.0,F,"I had soreness in the left arm for @ 2 days after the vaccination. No redness, no swelling. After that, no known problem. Exactly one week after the injection, On the morning of Tuesday, January 5, 2021, I noticed soreness in my left arm similar to what I had right after the injection. It was painful to extend my arm over my head. Later that day, I noticed a small 1 3/4"" x 1"" area of redness and warmth appearing at or right next to the area of the injection. Over the next 24-48 hours, the area grew and became swollen, more red, and warmer. The soreness in my arm didn't seem to change at all; it was painful to lift my arm overhead and to touch. The area grew to approximately 3"" x 4"" during that time period. On Thursday morning, 1/7/21, my PCP, inspected the area and felt the swelling and the warmth. She believed that I had likely developed cellulitis in the arm and placed me on cephalexin 500 mg, one capsule tid. I began taking that on Thursday afternoon, 1/7/21. By Friday evening, the area was barely visible, but was still warm and a little swollen. It was still slightly tender. Today, Saturday, 1/9/21, the area is still a little warm and slightly swollen, but not visible at all, and there is only tenderness if I press on the area.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,PVT,Rx: Wellbutrin XL 150 mg; Wellbutrin XL 300 mg; Zoloft 100 mg; Gabapentin 300 mg; Seroquel 25 mg; Xanax 1 mg; Finacea gel 15%; Metronidazole gel USP 0.85% OTC: Women's Formula Multivitamin 50+ Healthy Advantage; Vitamin D3 25 mcg; Vitami,None,Anxiety/depression,,Erythromycin Demerol Tree nuts,"['Injected limb mobility decreased', 'Injection site cellulitis', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Pain in extremity']",1,MODERNA,IM 931357,MT,70.0,M,"Became faint while driving home. Had to pull over for safety. Pain at the injection site. Low Grade Fever (under 102) Night Sweats, general malaise. Wife drove and rapid heart beat/faintness resolved within the hour.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,OTH,Fluoxetine 40 mg po qd,None,Chronic back and shoulder injuries with surgical interventions.,,None,"['Dizziness', 'Heart rate increased', 'Injection site pain', 'Malaise', 'Night sweats', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 931358,NJ,57.0,F,"Slight arm soreness for 3 days post vaccine. 7 days after the vaccine, an area half an inch to the right of the injection site became blotchy red ( 1"" wide x 2""long) it was slightly painful and itchy. It blanched when pressed. 8 days after the vaccine, the area was paler pink not as red and looked like a sunburn not quite as itchy. (1.5""wide x 2"" long). 9 days after vaccine area fading. 10 days after vaccine fading more but still not completely gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,PVT,,,,,Allergic to Sulfa drugs Allergic to Tequin (gatifloxacin) so I avoid all fluoroquinolone antibiotics like Cipro etc.,"['Injection site reaction', 'Pain in extremity', 'Pallor', 'Rash', 'Rash erythematous', 'Rash macular', 'Rash pruritic']",1,MODERNA,IM 931359,MO,67.0,F,Vaccine allergic reaction with cellulitis,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,PVT,Htn chol estrogen thyroid,None,Hypertension Thyroid Cholesterol Hormone therapy,,Lisinopril ( cough),"['Cellulitis', 'Full blood count normal', 'Hypersensitivity', 'Metabolic function test']",1,PFIZER\BIONTECH, 931361,TX,33.0,F,Chills and fever (99.68 F),Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Body temperature increased', 'Chills']",2,PFIZER\BIONTECH,IM 931362,,62.0,F,Pain at the injection site that continues 29 hours later; some fatigue day of and day after injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,UNK,,,,,penicillin and sulfa,"['Fatigue', 'Injection site pain']",1,MODERNA,IM 931364,MI,26.0,F,"Allergic reaction to covid shot on 11/8 Around 11:20am I got the shot by 11:25am i was dizzy my throat started to hurt, and my chest started to hurt. I was a shot of EpiPen and benadryl before I was wheeled down to the ED and was given dexAMETHasone at 1:02pm and ibuprofen at 2:36pm cause my head started to hurt more . Arm is till hurting at the injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"Tylenol, Nexplanon",,Back pain,Flu shot,"Eggs, apple, cherries, cheese, kelfex, Sulfa","['Chest pain', 'Dizziness', 'Full blood count normal', 'Headache', 'Injection site pain', 'Oropharyngeal pain']",1,PFIZER\BIONTECH,SYR 931366,OR,56.0,F,Lower abdominal cramping followed by diarrhea lasting for 2 days; then lower abdominal cramping followed by loose non-watery stools lasting for an additional 5 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/23/2020,2.0,WRK,"Ibuprofen 400-600mg, PRN Fish Oil 1400mg daily Melatonin 10 mg PRN",None,Rosacea,,None,"['Abdominal pain', 'Diarrhoea']",1,PFIZER\BIONTECH,SYR 931367,CO,54.0,F,"Dose 1 - headache mild 12 hours Dose 2 - foggy brain, sore eyes within 6 hours, severe headache, temp 101.2, myalgias within 10 hours lasting for 18 hours and fatigue lasting 48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,"Lexapro 10mg, levothyroxine 50mcg, multivitamin, bioflavonoids 2800 mg,",None,Hypothyroidism,,Penicillin,"['Fatigue', 'Feeling abnormal', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH, 931368,IL,35.0,F,"fatigue the evening of injection lasting 4-5 days, fever Tmax 99.9 starting 72hrs post vaccine lasting 24hr, myalgias x 48hrs starting with the fever, mild injection site soreness, managed with ibuprofen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/19/2020,3.0,PVT,adderall 5mg xr larissia OCP,none,positive ANA,,"latex, tree nuts, shellfish, fish, sesame, corn, soy","['Fatigue', 'Injection site pain', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 931369,MA,65.0,F,Recipient reported fever and chills.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,WRK,,,,,,"['Chills', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931370,IL,33.0,F,At 6:30 on Jan1 - painful irregular contractions continued despite hydration/tylenol - went to ER and they put me on monitor - normal fetal heartrate; observed contractions but were irregular. Discharged with pain medication and observation. Told to monitor contractions and if they became regular and within 5 min. to come back. Continued to have some irregular and painful contractions but they are very infrequent so haven't had to go back to be monitored. Had a subsequent folow up with OB (for a routine scheduled appt) and everything normal. Due date: Feb. 5 and uneventful pregnancy; no abnormal ultrasounds.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/01/2021,2.0,WRK,Prenatal Vitamins,none,none,,Penicillin- get a rash,"['Foetal monitoring', 'Uterine contractions abnormal']",1,PFIZER\BIONTECH,IM 931371,WI,31.0,M,Persistent but improved tenderness with new swelling noted 3 days after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/08/2021,3.0,OTH,Multivitamin,None,None,,Lactose intolerance,"['Swelling', 'Tenderness']",2,PFIZER\BIONTECH,SYR 931373,IN,38.0,F,Severe headache and overall body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,None,None,None,,None,"['Headache', 'Pain']",1,MODERNA,SYR 931374,MD,56.0,F,Body Muscle pains through out the body it started on 12/20/2020 The muscles were swollen One day I had a slight fever I also had dehydration. Virtual appointment with my doctor,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/20/2020,2.0,WRK,Yes spironolactone maxima Gabapentin Lyrica,No,fibromyalgia fatigue migraines,With the flu vaccine I have the same experience,none,"['Dehydration', 'Muscle swelling', 'Myalgia', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 931375,OK,72.0,M,"fever, I was shaking like I was freezing, I took aspirin and covered up with a heavy blanket. I fell asleep and woke up every few hours. I took aspirin at 8 am, I felt like I needed to pee, when I tried it, it hurt too much so I tried not to. I drank glasses of water, but I was still not able to pee more than a little.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,none,none,none,,everything,"['Dysuria', 'Nasopharyngitis', 'Pyrexia', 'Sleep disorder', 'Tremor', 'Urinary retention']",2,PFIZER\BIONTECH,IM 931376,MN,40.0,F,"Nausea, headache and arm pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Multivitamin Celexa,None,None,,None,"['Headache', 'Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 931377,GA,31.0,M,Started feeling fatigued and I also had a major headache after getting the moderna vaccination .,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,None,None,None,,None,"['Fatigue', 'Headache']",1,MODERNA, 931378,OK,67.0,M,"Nausea, headache, joint pain, chills, injection site extremely sore",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,SCH,"Potassium, ibuprofen,citalopram, triamterene,atenolol, amlodipine,valsartan, prednisone,citalopram, tramadol, asthma inhaler and breathing treatments. Once a month shot for asthma.",None,"Severe asthma, chronic back pain",,,"['Arthralgia', 'Chills', 'Headache', 'Injection site pain', 'Nausea']",UNK,MODERNA,SYR 931379,,44.0,F,"Myalgias, fever, nausea, 2 episodes of vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,none,none,obesity,,none,"['Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 931380,MI,72.0,M,"patient received the vaccine at 12:00 pm on 01/06/2021 at the hospital. after 6 hours and at around 6;00 pm patient noticed that he has difficulty hearing in general, but didn't give it much attention since he was doubting the fact he couldn't hear. next day he noticed that all voices coming from the right side is completely dimmed. till he used his phone for a phone call he realized he couldnt hear form his right ear at all. he found out he does hear normally from his left ear. today is day 3 from receiving the vaccine, and the symptoms has not resolved. with complete hearing loss form his right ear. no improvement since the incident. no treatment or medical intervention has yet occured prior to this report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"janumet, azor, lipitor, docusate,",,"diabetes, high blood pressure, hyperlipidemia",,nkda,['Deafness unilateral'],UNK,PFIZER\BIONTECH,IM 931381,SC,73.0,F,Patient fainted at 15 min mark after receiving vaccine. She was out for about 2 minutes. Her oxygen level dropped and blood pressure increase. Patient was given one dose of Nitro 0.4 mg SL and one tablet of Diphenhydramine 25 mg .,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,SEN,information not available at this time please reach out to (Compass Post Acute Rehab),information not available at this time please reach out to (Compass Post Acute Rehab),information not available at this time please reach out to (Compass Post Acute Rehab),,information not available at this time please reach out to (Compass Post Acute Rehab),"['Blood pressure increased', 'Syncope']",1,MODERNA,IM 931382,VA,25.0,M,"I (patient) experienced mild to moderate vertigo starting around 9pm that did not resolve after food and water intake. The vertigo was not exacerbated or improved by a particular movement or position. The vertigo continued for 3h, and resolved 1h after I took meclizine 25mg p.o . The vertigo resolved with meclizine but my balance was altered, but without impairment, until around noon the following day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/08/2021,3.0,PHM,Truvada 200-300mg,None known,No PMHx,,NKDA,"['Balance disorder', 'Vertigo']",1,MODERNA,IM 931383,CA,40.0,F,"Patient c/o of fast heart rate and dizziness. No signs of pallor, diaphoresis. No c/o of SOB or chest tightness. Treatment: Assessed heart rate of 108 BPM. Informed patient to take slow, deep breaths, remain seated and drink water. After 10 mins, patient feels much better and had no more complaint of dizziness. Heart rate assessed and it's WDL. Reminded pt. to just rest at home, avoid any extraneous activities and call PCP if any chest tightness or shortness of breath occurs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PUB,,,none,,,"['Dizziness', 'Heart rate increased']",1,MODERNA,IM 931384,MD,29.0,F,"About 5 minutes after receiving the injection I had a headache, my ears got hot, i felt nauseous and my eyes turned red. Today my arm is swollen and painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/10/2021,2.0,UNK,None,None,None,,Nonr,"['Feeling hot', 'Headache', 'Nausea', 'Ocular hyperaemia', 'Pain in extremity', 'Peripheral swelling']",UNK,MODERNA,IM 931385,IN,39.0,F,Headache body ache fever 100.0 tired. Lasted 24 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,UNK,Celexa omeprazole Colace stool softener Topamax,None,None,,None,"['Fatigue', 'Headache', 'Pain', 'Pyrexia']",UNK,MODERNA,SYR 931386,AZ,58.0,M,"Severe L shoulder pain and stiffness possibly due to vaccine injected high near the tip of the shoulder. Currently improving, but shoulder stiffness, weakness and popping present.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,None,Seasonal flu,"Childhood asthma, milder later onset adult asthma",,None,"['Injection site muscle weakness', 'Injection site pain', 'Injection site reaction', 'Joint noise', 'Musculoskeletal stiffness', 'Product administered at inappropriate site']",1,MODERNA,SYR 931387,,32.0,F,"Shortly after vaccine admin, patient reported feeling dizzy. Patient appeared pale. Assist x2 into recliner chair and was physically weak. Reclined and provided water and snacks. Patient progressively felt better with 35 min observation, felt ""normal"" at discharge from clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,,,,,,"['Asthenia', 'Dizziness', 'Pallor']",2,PFIZER\BIONTECH,IM 931389,FL,61.0,F,"itching, no hives, no shortness of breath, no change in vital signs,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PUB,,none,"hypertension, hypothyroid, history of asthma",,"NKDA, no food or medication allergies.",['Pruritus'],1,MODERNA,IM 931390,IN,65.0,F,fever/sweats for greater than a day,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/15/2020,01/04/2021,20.0,PVT,"allegra, edarbyclor, lumigan",none,"hypertension, urticaria, ocular hypertension",,none,"['Hyperhidrosis', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931391,,38.0,F,"Severe sore muscles, headache, body ache, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/09/2021,8.0,PVT,Wellbutrin 300 xl,None,"Depression, migraine",,None,"['Fatigue', 'Headache', 'Myalgia', 'Pain']",UNK,PFIZER\BIONTECH, 931392,OR,26.0,F,100.5 Fever started 8 hours after injection. Soreness and stiffness of whole arm started 4 hours after injection and lasted 24 hours. Body aches and light-headedness started 8 hours after injection and lasted 36 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,"Mirena IUD, 10mg Escitalopram",None,Asthma,,Nickel Allergy,"['Dizziness', 'Musculoskeletal stiffness', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 931393,PA,31.0,F,"Diagnosed with Cellulitis Extreme swelling, redness, hardness, heat, tender, ache, unable to lift arm above a certain point Swollen lymph nodes Pain into clavicle Received oral keflex - 4 times a day for 10 days - still taking",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/07/2021,8.0,PVT,Lexapro,no,No,,Erythromycin,"['Cellulitis', 'Erythema', 'Induration', 'Lymphadenopathy', 'Mobility decreased', 'Pain', 'Skin warm', 'Swelling', 'Tenderness']",1,MODERNA,IM 931394,CA,37.0,M,Employee called Employee Health office on 1/5/21 with complaint of lymph node pain to Left Arm. Referred employee to on the Job (Occ Med).,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/30/2020,2.0,PVT,,,,,,['Lymph node pain'],1,MODERNA,IM 931395,NY,61.0,F,muscle pain in left shoulder blade and under left breast; rash which resembles shingles without blistering; redness on left should blade and over left breast,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/03/2021,3.0,PVT,"Levitiracetam, Lisiniprol, Vitamin D, Estradiol, aspirin",none,none,,penicillin,"['Arthralgia', 'Breast pain', 'Erythema', 'Myalgia', 'Rash']",1,PFIZER\BIONTECH,IM 931396,IN,35.0,F,"Fatigue, body aches and joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Synthroid, fluoxetine",,Hypothyroidism,,"Sulfa, morphine","['Arthralgia', 'Fatigue', 'Pain']",1,MODERNA, 931397,PR,24.0,M,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,WRK,No,No,No,,No,['Headache'],2,PFIZER\BIONTECH,IM 931398,IN,35.0,F,"Arm pain, swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,Zyrtec D (one dose the night before vaccine),"Headache/migraine at time of vaccine, mild GI symptoms. Congestion the day prior.","Allergies, asthma",,Sulfa,"['Pain in extremity', 'Peripheral swelling']",1,MODERNA,SYR 931399,IN,24.0,F,"Fever up to 102.9, chills, headache, hypertension, tachycardia, dyspnea.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,None,None,Depression,,Toradol: hives Vancomycin: itch,"['Blood test', 'Chills', 'Dyspnoea', 'Headache', 'Hypertension', 'Pyrexia', 'Tachycardia']",2,PFIZER\BIONTECH,IM 931400,OH,58.0,F,"Delayed hypersensitivity reaction at injection site. Onset 8 days post-injection. Area approx. 5"" long 3"" wide. Well-demarcated oval area of slight erythema and very mild swelling. Principal symptom is pruritus. Slightly tender to touch but no pain unless it is pressed on. No systemic adverse reactions experienced. Today, day 9 post-injection reaction is similar to date of onset but no worse. I am just applying some topical cortisone and benadryl creams to reduce the itching. I thought I should submit this so you would have this in your data base. I have not experienced this type of reaction to any other vaccine I have received in the past but it is similar to the type of reaction I develop a few days after being stung by a bee. I anticipate a full recovery and look forward to getting my second dose of the vaccine despite this localized adverse allergic reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,WRK,Levothyroxine,,Hypothyroidism,,,"['Erythema', 'Pruritus', 'Swelling', 'Tenderness']",1,MODERNA,IM 931401,IN,35.0,F,Sore right arm with throbbing moderate headache that lasted for 24 hours. Pt took 500 mg tylenol po.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,None,No e,None,,Nkda,"['Headache', 'Pain in extremity']",1,MODERNA,IM 931402,PA,29.0,M,"12 hours after second dose of Pfizer vaccine, I began to experience muscle aches that grew in severity over the next 8 hours. I also developed a fever and headache with bilateral eye pain and pressure. I was unable to sleep due to the pain as it was quite severe.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Chlorthalidone, famotidine, potassium chloride, caffeine, psyllium husk",None,"Prehypertension, GERD",,Sulfa,"['Eye pain', 'Headache', 'Myalgia', 'Ocular discomfort', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 931403,KS,60.0,F,"Severe fatigue, headache, joint pain, fever. Started around 0700 next day of injection and these symptoms lasted 24 hours. Took Tylenol, Ibuprofen for fever. Even with these two onboard, continued low grade temp.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,WRK,"Lisinopril, Metformin",None,"HTN,Diabetes",,NKMA,"['Arthralgia', 'Fatigue', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931404,IN,35.0,M,"swelling discomfort of ulnar aspect of forearm, sinus headache, fever and extreme chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,none,none,none,,none,"['Chills', 'Peripheral swelling', 'Pyrexia', 'Sinus headache']",2,PFIZER\BIONTECH,IM 931405,NJ,49.0,M,"SEVER FLU LIKE ILLNESS OF FEVER, MUSCLE ACHE, JOINTS ACHES, CHILLS, SWEATING, HEADACHE, LOW APPETITE . SYMPOMS WERE DEFINITLY WORSE THAN REACTION I USUALLY GET AFTRT FLU VACCINE . HOWEVER, ITS SIMILAR OR MAY BE WORSE THAN REACTION I USUALLY GET AFTET TETANUS DIPHTERIA TD VACCINE. I AM NOT SURE IF HAVING HAD COVID1 9 IN MARCH 2020 MADE MY BODY OVER REACTING THE THE VACCINE DUE TO ALREADY PRESENCE OF ANTIBODIES. TO RESTED FOR 48 HRS WITH HYDRATION AND TYLENOL. 90 % OF SYMPTOMS ARE GONE AFTER 48 HRS.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,MELATONIN 7.5 MG ER AT BED TIME SAM-e 400 2 CAPS IN THE MONRING FISH OIL NATURAL SALMON OIL 2 CPS DAILY,NONE,NONE. BUT I AM A DOCTOR WHO HAVE HAD COVID 19 IN MARCH 2020 AND SURVIVED IT.,"INFLUENZA, TD",NONE,"['Arthralgia', 'Chills', 'Decreased appetite', 'Headache', 'Hyperhidrosis', 'Influenza like illness', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 931406,NY,45.0,M,"Severe Chills, Fever to 103 F, myalgias, fatigue, axillary lymphadenopathy",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Chills', 'Fatigue', 'Lymphadenopathy', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 931407,CA,32.0,F,Woke up next morning with very swollen lips/angioedema,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,"Doxycycline 200 mg, Prozac 40 mg, propranolol 80 mg, spironolactone 100 mg, tri-cyclen",None,"Chronic migraines, acne",,None,"['Angioedema', 'Lip swelling']",2,PFIZER\BIONTECH,IM 931408,PA,61.0,F,"started with metallic taste in mouth, progressed rapidly to clammy, light headed, elevated BP and HR. All of these progressed within minutes starting at 8:20 AM. Treated by drinking water, relaxation breathing, sitting for a half hour. Left the facility at approx 9:15 AM, but stayed close as requested and was told not to drive as still not feeling right, but better. As the day progressed, developed chills, fatigue, nausea, some shortness of breath, mild exacerbation of asthma- cough, then mild fever, runny nose, severe pain left arm. Symptoms finally moderated to just fatigue and body aches by the evening. Took 2 puff sof albuterol inhaler and 2 advil in the afternoon. Woke the next day with left arm pain, fatigue and continued to treat with advil through the day. Woke today, Jan 9 feeling normal. I did decline suggestion of going to the ER or my PCP when BP remained elevated at 11:30 AM on date of vaccination, chose to go home to self monitor.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Symbicort 80/4.5 inhaler, Singular, Atorvastatin, Claritin, Calcium with Vitamin D",,"asthma, high cholesterol",,none,"['Asthma', 'Blood pressure increased', 'Chills', 'Cold sweat', 'Condition aggravated', 'Cough', 'Dizziness', 'Dysgeusia', 'Dyspnoea', 'Fatigue', 'Heart rate increased', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'Rhinorrhoea']",UNK,MODERNA,SYR 931409,ID,45.0,F,"LIPS SWELLED UP AFTER 35 MIN , NEXT MORNING HEADACHE , BODY ACE AND ARM VERY SORE , LIPS STILL SWOLLEN BUT NOT AS MUCH",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,"VITAMIN D, MULIT VITAMIN",,"Cervical Cancer , no radiation or chemo, only hysterectomy, fibroid tumors in breast",tetanus vacc,"Sulfur, amoxicillin, penicillin, Aspen, Lambs Quarter, Pigweed, Thistle, Sage, Mugwort, Sagebrush, Shadscale ,Waterhemp, western, Black walnut, Band-aids","['Headache', 'Lip swelling', 'Pain', 'Pain in extremity']",UNK,MODERNA,IM 931410,UT,21.0,F,"Cold like symptoms, muscle weakness bilateral arms, headache, and fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Multi vitamin and vitamin D,Cold or possible sinus infection,,,Augmentin,"['Fatigue', 'Headache', 'Muscular weakness', 'Nasopharyngitis']",2,PFIZER\BIONTECH,IM 931411,VA,27.0,F,The injection was done in my shoulder capsule too high. I can?t move my arm fully and any small movements cause severe pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PUB,,,,,Mushrooms,"['Injected limb mobility decreased', 'Pain', 'Pain in extremity', 'Product administered at inappropriate site']",1,MODERNA,IM 931412,WV,53.0,F,"1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes left inguinal, fever of 102.3F, diaphoresis, chills, flushed face, change of taste and baseball sized swelling to injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,SEN,"NP Thyroid, Propranolol, Vitamin D, Metformin, Lisinopril, Protonix,",None,"Fibromyalgia, Hypertension, Hashimoto Thyroiditis, Prediabetes.",,None,"['Chills', 'Flushing', 'Headache', 'Hyperhidrosis', 'Injection site swelling', 'Lymphadenopathy', 'Pyrexia', 'Taste disorder']",2,PFIZER\BIONTECH,IM 931413,IL,42.0,M,"fatigue, muscle soreness (all over), chills, slight headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Levothyroxine 175MCG once daily and Vitamin D 125 MCG once daily,none,none,,none,"['Chills', 'Fatigue', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH,SYR 931414,VA,25.0,F,"Noticed Left Deltoid was itching today while at work (1-9-21), Lifted sleeve and Left Deltoid was noted to be red, warm to touch and in center of Deltoid it was noted to be a white patch about a quarter size in diameter slightly raised. (hive like white patch). Redness extending around the same area of full deltoid muscle. Itching about 6/10 level, ice pack placed to relieve some irritation. Notified employee health covid team.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/09/2021,8.0,WRK,Sprintec,,,,"Sulfa, Keflex, Allergy to Horses","['Injection site discolouration', 'Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Injection site warmth', 'Rash papular', 'Urticaria']",UNK,MODERNA, 931415,TX,53.0,M,Nasua on early am day 2,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,PVT,Nothing,Nothing,None,,Red Food Coloring,['Nausea'],1,MODERNA,SYR 931416,RI,41.0,M,Sudden onset of a burning sensation radiating from epigastrium to substernal. Rapid heart rate. Vitals obtained and patient was observed for 30 minutes. Patient stated symptoms subsided and vitals returned to normal.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,SCH,,,,,pcn,['Heart rate increased'],UNK,MODERNA, 931417,FL,60.0,M,"Myocardial Infarction: patient began to complain of severe chest pain 3 hours after the vaccine was given .. Vaccine NDC # 59267-1000-1. 0.3 ml given by RN. Patient called his PCP: ""... I had very bad chest and shoulder pains, neck pains and slight fever from 9 pm until early this morning (Jan 8). My blood pressure was 155/95 mmHg. Should I see you today? Still feel sore all upper body. Above message received at 0720 am (Jan 8) and the patient was called back at 0757 am (Jan 8): patient was told that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the patient go to the emergency room. Patient understood the importance to seek medical attention..... Emergency Room notes: seen by MD on Jan 9. Note at 0749: patient complained of chest pain on/off since received COVID vaccine on Jan 7. Pain was substernal and radiated to the left shoulder, assoc with some SOB. EKG obtained and revealed ST segment elevation and a ""cardiac alert"" was called.",Not Reported,,Yes,Yes,1.0,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,zinc sulfate omeprazole metoprolol levothyroxine sodium HCTZ echinacea purpurea extract cholecalciferol,malignant melanoma HTN hypothyroidism GERD,malignant melanoma,,codene lactose,"['Activated partial thromboplastin time prolonged', 'Arthralgia', 'Blood chloride decreased', 'Blood glucose normal', 'Blood potassium decreased', 'Blood sodium decreased', 'Cardiac ventriculogram left', 'Catheterisation cardiac abnormal', 'Chest pain', 'Dyspnoea', 'Echocardiogram normal', 'Ejection fraction decreased', 'Electrocardiogram', 'Electrocardiogram ST segment elevation', 'Hypokinesia', 'Myocardial infarction', 'N-terminal prohormone brain natriuretic peptide increased', 'Neck pain', 'Pain', 'Prothrombin time prolonged', 'Pyrexia', 'SARS-CoV-2 test negative', 'Stent placement', 'Troponin T increased']",1,PFIZER\BIONTECH,IM 931418,TX,38.0,F,"Headache, body aches, weird back pain . Took ibuprofen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,"Vyvanse, Wellbutrin, multivitamin",No,No,,No,"['Back pain', 'Headache', 'Pain']",2,PFIZER\BIONTECH, 931419,NC,25.0,F,Patient stated being lightheaded. Checked vitals and and blood pressure was a little low. Took blood pressure again after 10 minutes and was back to normal. Gave orange juice and water.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,birth control,no,no,,ceclor,"['Dizziness', 'Hypotension']",UNK,PFIZER\BIONTECH,SYR 931420,CO,54.0,F,"Chills, fever, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,Flonase and allegra,No,Asthma,,Peanut and monostat,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931421,TX,36.0,F,"Episodic uriticaria started 6 hours after 2nd dose and continue through the 36th hour post vaccination. Hives occur with very little palpation of skin. Benadryl has been used for symptomatic relief. Chills, low grade fever, and myalgias occurred at 20 hours post 2nd dose and resolved within 8 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"amlodipine, zyrtec, singular, escitalopram",none,"asthma, hypertension, anxiety, allergic rhinitis",,"bactrim, sulfa drugs; unknown food allergies; environmental allergies","['Chills', 'Myalgia', 'Pyrexia', 'Urticaria']",2,PFIZER\BIONTECH,IM 931422,MD,33.0,F,"24 hours later started with body aches and a ""strange"" lingering headache. Also had severe chills with body temp dropping to 96�F. Later that night had a low grade fever. Day 2, chills, cough, and just not feeling well",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PUB,"Humalog Insulin, ASA, Synthroid, Birth Control",,"Diabetes, Hypothyroid",,NKDA,"['Body temperature decreased', 'Chills', 'Cough', 'Headache', 'Malaise', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 931423,LA,71.0,F,"Approx 10-15 mins after I experienced a cloudy vision for a few seconds, after rapid blinking 10-15 times vision returned at the same time I felt a tightening of muscle or spasm sensation starting from behind my right ear moving around the base of my head to the middle this tightening sensation was very alarming and after getting stronger I alerted the nurse who monitored my condition and had me to stay longer than the 30 mins required. I felt not myself after reaching the lobby and sat a little while there. Once home took tylenol and rested for while woke with horrible headache including the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Olmesarten 40mg (1), Nabumetone 500mg (1), Gralise 600mg (1), Savella 50mg (1).",,"Lupus SLE, Fibromyalgia, Arthritis, High Blood Pressure, Pre Diabetes, Mild Stroke, Rheumatic Fever.",70,"Sulfur, Codeine, Ultram/TR, Amoxcillin & Clavulante Potassium 875/125mg (Severe diarrhea), Ciprofloxin 500mg (Severe foot pain/Heel), Venlafaxin ER 75mg (Severe Headaches for2-3 days with 1 dose).","['Feeling abnormal', 'Headache', 'Muscle spasms', 'Muscle tightness', 'Vision blurred']",1,MODERNA,IM 931424,,33.0,F,"Pt developed a large red itchy rash on her neck / chest area, she stated she felt fine but was observed trembling. She was transported to ED (5 min transport) She was treated with: Benadryl 25mg IV X1, Solumedrol 60mg IVX1, famotidine 20mg IV X 1 - diagnoses was allergic reaction Pt improved after treatment She was observed from 09:11 until 10:33",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,pt reports latex allergy - non anaphylaxis reaction,"['Hypersensitivity', 'Rash', 'Rash erythematous', 'Rash pruritic', 'Tremor']",2,PFIZER\BIONTECH,IM 931425,MN,65.0,M,"Shortness of breath, pounding irregular heart beats, pressure in center of the chest, clumsiness. I had a symptom free case of Covid-19. I took 25 mg instant release Metoprolol beta blocker I keep around for a flutter. The symptoms I had after the vaccine were in no way related to the symptoms I have had with aA flutter. The worst of the symptoms after the covid vaccine lasted from 9:00 pm to 12:00 pm or so when I fell asleep. Diagnosed Positive with Covid-19 on 12/28/2020 by saliva test VAULT TESTING SITE. The day of this Covid-19 Vaccination was my first day off of quarantine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,"Losartan, Amlodipine, Chlorthalidone, Potassium CL Micro 10 MEQER Tabs., Terbinafine, Nexium, Vitamin E, B Vitamins, Co Q 10. Glucosamine, Vitamin D, Magnesium.",Had been diagnosed with Covid-19 on 12/28/2020. Quarantine had just ended the day I got the vaccine.,"High blood pressure, barretts esophagus, gerd, ankle joint replacement on 8/10/2020. Heart disease, including occasional flutter.",,Antibiotics.,"['Chest discomfort', 'Clumsiness', 'Dyspnoea', 'Palpitations', 'Somnolence']",1,PFIZER\BIONTECH,SYR 931426,SC,25.0,F,"Nausea, migraine, joint pain, chills, night sweats, muscle pain, muscle fatigue, tiredness. All symptoms occurred approx 12 hours after vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Birth control,None,None,Flu shot,NKDA,"['Arthralgia', 'Chills', 'Fatigue', 'Migraine', 'Muscle fatigue', 'Myalgia', 'Nausea', 'Night sweats']",UNK,PFIZER\BIONTECH, 931427,MT,46.0,F,"Onset: pain/swollen R axillary lymph node, woke me up at 3 am 12/30; then late afternoon 12/30 onset pain/swollen R supraclavicular lymph node. Duration for both was approx. 8 days with very gradual lessening of severity. Can still palpate slightly swollen R axillary, but soreness almost completely resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/30/2020,6.0,OTH,Natural Calm magnesium supplement,none,"Hx juvenile arthritis (neg. rheumatoid factor); possible malignant hyperthermia (based on episode, no familial hx); heterozygous prothrombin gene mutation",,Erythromycin,"['Lymph node pain', 'Lymphadenopathy', 'Sleep disorder']",UNK,MODERNA,SYR 931428,MD,47.0,F,"Arms started tingling immediately after injection but did not think it was a significant response. As I was driving home my throat began to swell, my heart was racing, my chest got red and I was very shaky - this occured appx 50 minutes post injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Estroven One a Day Multivitamin Tumeric,None,None,,Cipro,"['Flushing', 'Heart rate increased', 'Nervousness', 'Paraesthesia', 'Pharyngeal swelling']",1,PFIZER\BIONTECH,IM 931429,TN,47.0,F,Pfizer-BioNTech COVID-19 Vaccine EUA,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/09/2021,6.0,UNK,"Zoloft, simvastatin, and Ambien",None,OCD,,Sulfa drugs,['Unevaluable event'],1,PFIZER\BIONTECH,IM 931430,NJ,32.0,F,"General body aches and chills, nausea lasting 72 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"BCP, multivitamin, Zyrtec",,,,Sulfa drugs,"['Chills', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,IM 931431,TX,49.0,F,"Initial arm soreness resolved by 1/2/21 and there was no redness. On afternoon of 1/6/21 injection site and outward about 2?radius from site my right upper arm rapidly turned very red, painful and hot and also dizziness and extreme fatigue. I had a virtual visit with my doctor and he diagnosed cellulitis. Treatment of 5 day medrol dose pack and 10 day course if Bactrim DS 800-160. Symptoms are improving. Rapid test for COVID-19 on 1/7/21 (due to fatigue/dizziness) with negative result.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/06/2021,8.0,OTH,Synthroid,None,"Mild intermittent asthma, hypothyroid",,Penicilin,"['Dizziness', 'Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'SARS-CoV-2 test negative']",1,MODERNA,IM 931432,FL,34.0,F,At around 11:45pm tingling started in my left eyebrow. I thought there was something in my eyebrow and after time of wiping it a few times I went to look into the mirror and realized that nothing was there. about and hour later I got a drink and a snack to eat and I realized I had a numb sensation in the left corner of my lip. As a nurse I went though the signs of a stroke with 2 other nurses I called. Everything was normal other than that sensation. Thinking I was just overly tired I went to bed. When I woke up the next day I felt okay until I went to drink some coffee and the numb sensation in my corner lip was still there. Now I was concerned and called employee health and was instructed to go to the ER to role out a stoke. I followed employee health's instructions and went to the ER. I was diagnosed with facial paresthesia and discharged with instructions to come back if symptoms got worse. Symptoms persisted all day and around 7 I called my mom on video chat to show a visual facial twitch on the left side of my face. right after I got off the phone with her the left side of my face drooped and my fiance immediately drove me to the closest ER. I was seen immediately and they decided to admit me. The did labs and head CT. They admitted me to labor and delivery because there were no other rooms. The next day I was seen by a neurologist and many doctors.,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Zoloft 50 mg Clonazepam 0.5mg,none,none,,none,"['Computerised tomogram head normal', 'Electroencephalogram normal', 'Facial paralysis', 'Fatigue', 'Hypoaesthesia oral', 'Laboratory test', 'Magnetic resonance imaging normal', 'Muscle twitching', 'Paraesthesia', 'Scan with contrast', 'Ultrasound Doppler normal']",1,PFIZER\BIONTECH,IM 931433,IL,28.0,F,Joint aching. Muscle aching. 7/10 headache behind eyes. Chills. Fatigue.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,Multi vitamin. 2000 u vitamin D.,None,Lyme disease. (Completed treatment 10/2020),,None,"['Arthralgia', 'Chills', 'Eye pain', 'Fatigue', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH,IM 931434,MD,45.0,F,Extreme itching and blotchy redness at site. Mosquito bite itching.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,"Vit D, vit C, turmeric, zinc, primrose oil, b12, axataxin,",,,,Sulfa,"['Injection site erythema', 'Injection site pruritus', 'Rash macular']",1,MODERNA,SYR 931435,IN,28.0,F,"Beginning at 6:00 AM the following day: lethargy, joint pain/soreness, body aches, chills, fever (highest was 101.4), nausea/vomiting, and headache. Symptoms lasted for 9 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,None,None,None,,None,"['Arthralgia', 'Chills', 'Headache', 'Lethargy', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",1,MODERNA,SYR 931436,CA,45.0,F,"Patient stated she was experiencing blurry vision, nausea and dizziness approximately 10minutes post vaccination. Vitals were stable BP 137/87 P. 72 Sp02 99% Patient was provided cold compress and monitored for an additional 20minutes. Patient's s/s resolved. Patient stable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,Hx of COVID-19 DX 11/2020,,,,"['Dizziness', 'Nausea', 'Vision blurred']",1,MODERNA,IM 931437,CA,53.0,M,"Complaint of racing HR, no other symptoms, no SOB. Verbalized feeling nervous/anxious with some vision changes. PMH: HIV+ and hyperlipidemia. 0735: HR 110, BP 125/80 L arm, RR 17. 0740: HR 98. Did not take am medications, no breakfast or water, only 2 sips of coffee. Gave him water and he stated feeling better at 0800 and left site and stated partner would drive him home. No treatments administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"odefsey, atorvastatin",no,HIV+,,Midrin and Tessalon Perles,"['Anxiety', 'Nervousness', 'Palpitations', 'Visual impairment']",1,PFIZER\BIONTECH,IM 931438,MO,54.0,F,"12/31--slight headache that morning, by that evening migraine level headache 01/01/21-early morning fever 101.9, severe chills, severe aches of lower back, hips, joints, loss of appetite these symptoms continued thru 01/02/21 01/03/21 fevere abated, still body aches but much less severe, fatigue 01/04/21 fatigue only slowly resolving",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/31/2020,3.0,PVT,"meloxicam, gabapentin",,"degenerative joint disease, high cholesterol, obesity, high blood pressure, migraines",,"adhesive,mango, bananas, codeine, demerol, compazine","['Arthralgia', 'Back pain', 'Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Migraine', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 931439,KS,32.0,F,7 days after vaccination large red swollen area at injection site along with numbness tingling on right now arm. Reddened area hot to touch-approximately 2 inches in diameter. Still present 11 days post vaccine now 3-4 inches. Itching and tingling of affected arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,WRK,Lipotor Mirena,Cold Sore-1 week prior,Hyperlipidemia,,None,"['Full blood count', 'Hypoaesthesia', 'Injection site erythema', 'Injection site swelling', 'Metabolic function test', 'Paraesthesia', 'Pruritus']",1,MODERNA,IM 931440,NE,45.0,F,"Significant fatigue, myalgias, nausea, headache, sore throat, arm soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,None,Covid-19 1 month prior,None,,None,"['Fatigue', 'Gaze palsy', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Pain in extremity']",1,MODERNA,IM 931441,PR,88.0,F,Seizure,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PHM,,No,,,No,['Seizure'],1,MODERNA,IM 931442,FL,36.0,F,"Rapid heart rate and feeling of cold almost immediately after receiving vaccine. Hands turned white and cold. Left hand tingling. Not reported to observer. Unsure if this was related to anxiety or a true reaction. Chills and anxiety throughout the rest of the day/night. Insomnia. Feeling of pressure in head, joint aches throughout the night following vaccine and the next day. Sore arm. All symptoms resolved by 01/09/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Ibuprofen,Cold sore,Ventricular Septal Defect,,None,"['Anxiety', 'Arthralgia', 'Chills', 'Feeling cold', 'Head discomfort', 'Heart rate increased', 'Insomnia', 'Pain in extremity', 'Paraesthesia', 'Peripheral coldness']",1,MODERNA,IM 931443,CA,41.0,M,"Employee received covid vaccine at 813am. At 830, he reported flushing sensation on his face. Vital sign at 830: BP 109/81, HR 80, O2 99%. He denies wheezing, sob, chest discomfort, sore throat, difficulty breathing, pruritic. Employee was provided fluids and reports symptoms gradually improved. On assessment, employee's face was flushed, mild erythema on the upper arm. No angioedema. Lung sounds clear. Heart sounds normal. No acute respiratory distress. Employee was observed closely in clinic. Symptoms improved. At 855, BP 107/79, Hr 72, O2 100%. Employee was discharged from clinic to return home. He was instructed to closely monitor his symptoms. If his symptoms worsen or persist, he needs to go to urgent care or go to ED. He stated understanding. He left in stable condition. No acute distress.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,None,None,None,,None,"['Erythema', 'Flushing']",1,MODERNA,IM 931444,,22.0,F,"99.9 degree F fever with chills for 24 hours, ibuprofen taken to lessen fever, fever subsided 24 hours after vaccine was given",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,IUD,None,None,,Bactrim,"['Chills', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931445,IL,23.0,F,"Feeling drowsy, headache, and weak.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PUB,"Escitalopram; took it 5-10 minutes, at the scheduled time, before the vaccine was given.",None,None,,None,"['Asthenia', 'Headache', 'Somnolence']",1,MODERNA,SYR 931446,TN,69.0,M,My arm got very red with a knot on it. I started taking benadryl and it is doing better but the redness is going down my arm. I think in a day or two it will be better.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/04/2021,5.0,PUB,none,no,no,,no,"['Erythema', 'Nodule']",2,MODERNA, 931447,NY,25.0,M,Left supraclavicular adenopathy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/09/2021,5.0,PVT,,,,,,['Lymphadenopathy'],1,MODERNA,IM 931448,,24.0,M,Chills began around 9:30pm which lead to a high fever of 104F at 11pm. Fever subsided within 30min of taking 400mg ibuprofen.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,None,None,Asthma: rarely need inhaler (~once per year),,"Allergy to: Shellfish (clams, muscles, scallops) Pollen (seasonal allergies) Mold",['Pyrexia'],1,MODERNA,IM 931449,CA,45.0,M,There was immediate pain and tenderness at the Vaccination site. I then developed a severe headache and muscle aches. I proceeded to develop chills that I couldn't get to go away no matter how much I warmed up.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,"Bupropion, Zetia, Fenofibrate, Citalopram, Omeprazole, Diclofenac, Men's one a day vitamin","Covid 19, 12/7/2020","Asthma, Elevated Cholesterol, Depression, Acid Reflux",,None,"['Chills', 'Headache', 'Injection site pain', 'Myalgia']",1,MODERNA,IM 931450,WA,26.0,F,"Body ache, headache, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,WRK,"Birth control, and sertilne",None,None,,"Penicillin and amoxicillin, menthol","['Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 931451,,37.0,F,Pt received vaccine in the morning and returned after completing her shift to report chest tightness. She was sent to ED for evaluation She was worked up to rule vaccine adverse event She was not treated with medication discharged home wt 1700 with diagnosis of costochondritis,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Anxiety', 'Chest discomfort', 'Costochondritis', 'Laboratory test normal']",2,PFIZER\BIONTECH,IM 931452,NY,40.0,F,"RIGHT ARM REDNESS AND WARMTH, LOCAL INJECTION SITE REACTION",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/04/2021,2.0,PVT,"Synthroid, HCTZ, Lo-Loestrin",,"Hypothyroid, HTN",,NKDA,"['Injection site erythema', 'Injection site warmth']",UNK,MODERNA,IM 931453,NJ,40.0,F,"Hives (moderate) on back, legs, chest, torso and sides for past 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,PUB,None,None,None,,None,['Urticaria'],1,MODERNA,SYR 931454,MD,68.0,F,1/9/2021 - at 10:10am I experienced my first-ever episode of dizziness. If I had not gotten on the floor I would have fallen on the floor. Then broke out in a whole body sweat. I stayed on floor for about 4-5 minutes. I did not lose conscience. Then went to sit on recliner. Felt a twinge of nausea. After 2 hours I got up and felt okay.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,WRK,synthroid; probiotics; Vit D and multivitamin,None,none,,none,"['Dizziness', 'Hyperhidrosis', 'Nausea']",1,MODERNA,SYR 931455,VA,38.0,M,"Woke up 12hrs after vaccine with shaking chills in bed at 4am. For the entire day after the vaccine I was unable to do anything except sleep. Had headaches, fatigue, muscle aches, fevers, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Chills', 'Fatigue', 'Headache', 'Hypersomnia', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931456,CA,48.0,F,"Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter in her chest shortly after vaccination done 12/22/20 (while being observed). States she informed staff, RNs in clinic state this employee did not report any reactions to clinic staff. Employee returned to work in ICU, states ""felt better by end of day"". 12/23/20 states swelling to both feet, reports 6+ (?) pitting edema. 12/24/20 states abdomen swollen. Called advice nurse who recommended she report to ED. Employee declined ED and took Benadryl instead. 12/26/20 states face swollen, joint pain, legs felt like they were on fire, could barely walk. 12/28/20 states feels better . Left foot a little swollen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,"Beta Blocker, Thyroid, Cymbalta, Cholesterol Med, BP Med",Fibromyalgia,"Fibromyalgia, Hypertension, High Cholesterol",,"Ambien, Erythromycin, Gabapentin, Lisinopril, Metaxalone, Penicillin, Sulfa","['Abdominal distension', 'Arthralgia', 'Dysaesthesia', 'Gait disturbance', 'Palpitations', 'Paraesthesia', 'Peripheral swelling', 'Swelling face']",1,PFIZER\BIONTECH,IM 931457,CA,34.0,F,"Symptoms started about 3 hours after injection, and worsened over the course of the following 36 hours. Symptoms include fever (Tmax 104 F) unresponsive to antipyretics, chills, severe myalgias, headache, and sore throat.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Wellbutrin, Effexor, Vitamin C, D, and B, Zinc, Pepcid, melatonin, Biotin",None,Exercise induced asthma,,"Sulfa, codeine","['Feeling cold', 'Headache', 'Myalgia', 'Oropharyngeal pain', 'Pyrexia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,IM 931458,CA,34.0,F,"fever at 12h and 28h after vaccine, profound body aches (muscle, joint, headaches) that were debilitating and could not go to work",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,birth control,none,none,,none,"['Arthralgia', 'Headache', 'Impaired work ability', 'Myalgia', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931459,MN,33.0,F,"I experienced soreness of left arm in a couple of hours after the shot with mild irritation and redness on the injection site, but symptoms all went away in 1-2 days. However, in one week after the vaccination (1/5/21), I started to develop lymphadenopathy under my right arm, and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,Vitamin D 1000unit capsule once daily,No known,No chronic health conditions,Flu vaccine in 9/2020,No known allergies,"['Fatigue', 'Injection site erythema', 'Injection site irritation', 'Injection site pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 931460,AL,48.0,F,"Nausea, dizziness, fatigue, brain fog",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,"Amlodipine, buspar, lexipro, HCTZ, Claritin, singulair, symbicort, vitamin D, biotin",,"Asthma, eczema, depression and anxiety",,Latex and bananas,"['Dizziness', 'Fatigue', 'Feeling abnormal', 'Nausea']",UNK,MODERNA, 931461,IN,38.0,M,Stomach cramps back pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,01/01/2021,31.0,PVT,None,None,None,,None,"['Abdominal pain upper', 'Back pain']",1,PFIZER\BIONTECH, 931462,MD,27.0,F,Headache Fever Chills Body aches Nausea Diarrhea Joint pain Reddness and swelling to injection site Cold sweats,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,Meclizine Verapamil Zofran,None,Migraines Vertigo,,Doxycycline,"['Arthralgia', 'Chills', 'Cold sweat', 'Diarrhoea', 'Headache', 'Injection site erythema', 'Injection site swelling', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 931463,NH,52.0,M,Soreness at injection site for 24 hours. Headache for 48 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,,,,,,"['Headache', 'Injection site pain']",1,PFIZER\BIONTECH,IM 931464,MA,52.0,F,"Nausea, fatigue, hallucinations? Was under observation, emt was called, vitals were normal. Recovered within 3 hours with no further intervention.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,SEN,N/a,N/a,None,,NKDA,"['Fatigue', 'Hallucination', 'Nausea']",1,PFIZER\BIONTECH,IM 931465,MD,49.0,F,Heart rate went up to 162 within 10 mins of receiving the shot which causes blood pressure to shoot up to 157/79. normal blood pressure is usually below 120/80,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Caltrate,,,,Sulfa drugs,"['Blood pressure increased', 'Heart rate increased']",1,MODERNA,SYR 931466,CA,60.0,F,"Close to 1100 she began to complain of not feeling well, primarily complained of feeling dizzy, feeling a little weird but felt it would pass. Around 1115 she was still dizzy, stated she didn?t have much to drink or eat, so we brought her water and a snack. No hx of diabetes. 1120 she looked flushed, and now had tingling in her left arm. Took her BP 140/70, HR 70, temp on her forehead 97.1. 1130 she continued to have a strange feeling in her arm from her shot site to her left hand, and up her neck. Vaccinator counseled her to take an antihistamine once she gets home. Patient called her husband and her son who would take 40 minutes to come get her. She began to exercise her left arm, and began to feel better. She left with her family at approximately 1:00, still a little dizzy, no longer flushed with less discomfort. We called her at 7;15 pm and she reported that symptoms had resolved. Took Zyrtec. Extended observation and sent home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,pantoprazole,none,high cholesterol,,"Sulfas, dogs, grass","['Discomfort', 'Dizziness', 'Feeling abnormal', 'Flushing', 'Malaise', 'Paraesthesia']",1,MODERNA,IM 931467,PA,55.0,F,Left arm sore from shoulder to fingers day after the injection which was expected. At around 12:00 PM on 2nd day after injection (1/7) pain went up neck and entire left side of head. Left eye pain/heaviness. Sensitivity to light and noise. Had to take Motrin 800mg. Still present on 1/8 but less severe. However at 12:00 PM on 3rd day after injection (1/8) developed pain/numbness/tingling in left leg. Called PCP office and was instructed to take Tylenol and/or Motrin and to go ahead with 2nd injection. ? hemiplegic migraine?,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/07/2021,2.0,PVT,"AM: Baby ASA, Omeprazole 20mg, Vitamin D, Biotin, Krill Oil, Vitamin E PM: Zoloft 50mg, Probiotic",None,None,,None,"['Asthenopia', 'Eye pain', 'Headache', 'Hemiplegic migraine', 'Hypoaesthesia', 'Neck pain', 'Pain in extremity', 'Paraesthesia', 'Photophobia']",1,MODERNA,IM 931468,IN,30.0,M,"Nausea, vomiting, low-grade fever, swelling around injection site, pain around injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"Lisinopril, Wellbutrin, Descovy, Adderall",,"Obesity, anxiety, depression, high blood pressure",,Codeine,"['Injection site pain', 'Injection site swelling', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,SYR 931469,MN,32.0,F,"0820 received vaccine 0830 reported feeling hot, tingly, sweaty 0835 elevated BP, elevated HR - placed in supine position, offered oral fluid 0840 continued elevated BP, elevated HR - continued to monitor 0915 continued elevated BP, elevated HR - continued to monitor 0930 reported feeling hot, tingly, sweaty with position change from supine to sitting, BP reduced, HR WNL 0935 transported to ED for continue symptoms > 1 hour post administration",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,,Denies,,,,"['Blood pressure increased', 'Feeling hot', 'Heart rate increased', 'Hyperhidrosis', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 931470,IN,43.0,M,"At 23 hours after injection, fever began. The fever was followed by headache, tiredness, and soreness. The fever ultimately rose to 103.3 and stayed around there for several hours. I took Tylenol for the symptoms. I woke up in the night with chills and night sweats. Into the second day of symptoms, only a slight headache and tiredness remain. Continuing with Tylenol for treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Multivitamin, fish oil supplement, turmeric supplement",None,None,,Negative reaction to melatonin supplement,"['Chills', 'Fatigue', 'Headache', 'Night sweats', 'Pain', 'Pyrexia']",1,MODERNA,SYR 931471,IN,30.0,F,"Headache and body pain beginning following morning, progressive throughout day adding chills/sweats by 2pm which resolved by about 10 pm. Residual minor headache next day",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Levothyroxine,None,Hypothyroidism,,None,"['Chills', 'Headache', 'Hyperhidrosis', 'Pain']",2,PFIZER\BIONTECH,IM 931472,IL,32.0,F,"Chills, body aches, lethargy, headache, entire left arm pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Mirena IUD, melatonin, daily multivitamin",N/a,N/a,"Pfizer covid vaccine, 1st dose, lot EK5730, left arm pain, fatigue, headache",NKDA,"['Chills', 'Headache', 'Lethargy', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 931473,IA,41.0,F,"1st event: Metallic taste in mouth; then felt like I had a 'fat lip' on left lower lip; and left half of tongue- tip only- went numb Injected with 50mg of Benadryl in my left upper thigh 2nd event: 4.5 to 5 hours later- Metallic taste returned {Liken to cold house key metallic taste} in center of tongue- width of 1-2 mm, taste lasted 30-45 seconds. Left side of lips went numb (upper and lower) with lower again feeling swollen. Left upper part of tongue again went numb. Took 25 mg tablet of Benadryl. Odd feeling in tongue lasted for a few days after vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,WRK,Prescriptions: Morning- D-Amphetamine Salt Combo 20MG tabs (x2); Cetirizine 10mg; Hydroxyzine HCL 25mg; Venlafaxine ER 37.5 mg; Venlafaxine ER 75 mg; and Gabapentin 300 mg Temporarily: Doxycycline 100mg Noon: Gabapentin 300 mg; D-Amphe,"Sinus infection- on doxycycline 100 mg (2 x daily)- started medication on December 28, 2020 10 day prescription",Chronic thoracic outlet syndrome- left arm; migraines with and w/o aura; depression with seasonal effective; anxiety attacks; organic obstructive sleep apnea,,"Allergies: Amoxicillin; Sulfa; Latex; Pollen- Ash, Birch, Cottonwood; Cat dander Intolerance/ Sensitivities: Fructose and Lactose Allergies/ Sensitives/ Unable to fully classify: Benzacain- slow to wake; Epinephrine- Idioventricular conductive delay; Lorazepam- memory loss Food Allergies: Avocado; banana; kiwi; shellfish; chestnuts (linked to latex-but have not officially tested theory.)","['Dysgeusia', 'Hypoaesthesia oral', 'Lip swelling', 'Paraesthesia oral', 'Tryptase']",1,PFIZER\BIONTECH,IM 931474,,55.0,F,"fever, chills, body aches, nausea, headache, cough-over the counter meds symptoms lasted about 2-3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,UNK,,,,,,"['Chills', 'Cough', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931475,NY,23.0,F,"Same day (1/5/2020): tenderness, swelling, throbbing pain at the injection site (left upper arm); difficulty raising arm completely within 3-4 hours post-injection Next day (1/6/2020): slight tenderness at the injection site, dizziness Next day (1/7/2020): slight fever, chills, nausea, severe headache; no tenderness at the injection site Next day (1/8/2020): no fever, chills, nausea, headage; some dizziness and small rash on lower left arm/wrist area Next day (1/9/2020): no more rash",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Chills', 'Dizziness', 'Headache', 'Injection site pain', 'Injection site swelling', 'Nausea', 'Pain', 'Pyrexia', 'Rash']",UNK,MODERNA,IM 931476,IN,42.0,F,"Severe pain and swelling to left arm, fever of 102, general malaise, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,UNK,"Synthroid, iron, colace, vitamin d, hdyrochlorothiazide, trazodone, requip, imitrex, glucosamine chondroitin with msm, zyprexa, zofran, flexeril",None,"Hypothyroidism, migraines,",,"Morphine, compazine, metoprolol","['Malaise', 'Nausea', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 931477,CA,50.0,F,on 1/9/21 I noticed a red oval on my arm at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/09/2021,9.0,WRK,"prozac, B12, vit D, taurine, saffron, gaba, melatonin, omegas,",none,anxiety/depression,,sulfa,['Injection site erythema'],1,MODERNA,IM 931478,IN,34.0,M,Myalgia (5/10 pain) much more than with a typical flu vaccine. Significant swings in body temperature ranging from chills to sweating for >24 hrs without a definitive fever.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,None,None,None,,None,"['Body temperature fluctuation', 'Chills', 'Hyperhidrosis', 'Myalgia']",2,PFIZER\BIONTECH,IM 931479,CT,63.0,F,MODERATE HEADACHE FEVER 100.8 MODERATE BODY ACHE FATIGUE,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,OTH,"Vit C, E. Zinc Pyridostigmine Levothyroxine Tremfya, Methotrexate 15mg IM weekly Benicar and Spririnolactone","Myastenia gravis, Psoriatic arthritis, Hypothyroidism, Hypertension",As Above,,No,"['Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 931480,IN,35.0,F,"Pain in arm day of but no redness or swelling up to the night of. Pain continued through night (affecting sleep) and through day. Around 2:15 pm next day I noticed a red ring and swelling at injection site, almost 2 inches in diameter, warm to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,,,UNK,"Zoloft 50 mg daily, 50 mg Benadryl PRN at bedtime I believe I took the night before vaccination.",None,Seasonal and environmental allergies,,None,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity', 'Sleep disorder']",1,MODERNA,IM 931481,PA,61.0,F,"Pain at injection site lasting 48 hours, fatigue, headache, muscle pain, chills, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Zoloft Zocor Metoprolol Magnesium Lo dose Aspirin Buspar,None,High cholesterol Depression Anxiety,,None,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea']",1,MODERNA,IM 931482,UT,40.0,F,"Shaking chills, nausea/vomiting, headache, palpitations. No symptoms with initial vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Vitamin D3, Vitamin C, Omeprazole",Active Covid infection between covid vaccines; Initial vaccination date 12/18/2020. Symptom start 12/27/2020 with positive test. 2nd vaccine 1/8/2021,None,,NKDA,"['Chills', 'Headache', 'Nausea', 'Palpitations', 'SARS-CoV-2 test positive', 'Vomiting']",2,PFIZER\BIONTECH,IM 931483,FL,43.0,F,"On Friday, January 8, 2021, I woke up with diarrhea. By 5:00 AM, I was throwing up (multiple times) and had diarrhea. I then began to develop muscle aches and chills with a low grade temperature. I ran a low grade temperature (as high as 100.4) on and off all day on January 8, 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/08/2021,2.0,PVT,Daily multivitamin - Vitafusion,"None - I did have elective surgery 3 weeks prior, but my physician said it was fine for me to get the vaccine.",None.,,Bactrim - Sulfa drugs give me hives,"['Body temperature increased', 'Chills', 'Diarrhoea', 'Myalgia', 'Vomiting']",1,MODERNA,IM 931484,MA,78.0,F,"Patient was unresponsive in her room during the night, had gotten the vaccine this morning, 911 called. Had right arm pain and loss of consciousness. EMS got 180/104 BP and blood glucose was 122. Was transported to hospital. Returned to the facility the next day with no complications, was just fatigued.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/08/2021,01/08/2021,0.0,SEN,,,,,,"['Blood glucose normal', 'Fatigue', 'Loss of consciousness', 'Pain in extremity', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 931485,WA,28.0,F,"Soreness in the site of injection on the day of vaccination. Muscle aches, headache and fever began 12 hours after injection. Fever spiked up to 104.1F 16 hours after vaccination. Took Tylenol at hour 16 to help bring fever down. Temperature now 100F and it has been 18 hours since vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Headache', 'Injection site pain', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931486,WA,39.0,F,"Reported feeling onset of dizziness, right side of eye vision change, flushed, and clammy about 7 minutes after dose #2 of vaccination. No hx of adverse vaccine response. Only seasonal allergies. High-risk pregnancy at 25 weeks. Hx of feeling dizzy when she gets up suddenly, otherwise, no other medical issues. V/S taken over 45 minutes with noted decrease in BPs which was not normal for her. Apple juice x3 given at increments of 15 minutes and finished 1 bottle of water. Reports feeling better and then s/s returned. States she feels tired during episodes and back to normal. Advised to be evaluated in ED since her drive was more than 55 minutes away from hospital. Agreeable and was transported to ED for observation. B/P: 9:51 110/58, 10:09 92/58, 10:25 91/49 HR: 9:49 63, 9:59 80, 10:09 80, 10:25 80 SpO2: 9:49 99, 09:59 99, 10:09 99, 10:25 97 No other interventions given. Wheeled to the ED, room 505 at 10:41. Report given to RN.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,NONE,NONE,HIGH RISK PREGNANCY,,NONE,"['Blood pressure decreased', 'Cold sweat', 'Dizziness', 'Fatigue', 'Flushing', 'Visual impairment']",2,PFIZER\BIONTECH,IM 931487,NJ,42.0,F,2 quarter sized raised red itchy bumps,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,PVT,Zyrtec,,,,Kiwi,"['Rash erythematous', 'Rash papular', 'Rash pruritic']",1,MODERNA,IM 931488,PA,33.0,F,"I experienced a rash/hives/redness on my chest after 10-20 mins. My breathing was fine, but the rash was starting to spread and my chest felt a hot and cold sensation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"prenatal vitamin, vitamin c - 1000 mg, D3 - 10,000 iu",Covid in July 2020 Appendectomy in December 2020,None,,"peaches, apples, penicillin, ampicillin","['Erythema', 'Feeling of body temperature change', 'Rash', 'Urticaria']",1,MODERNA,SYR 931489,TN,33.0,F,I woke up with extreme sore throat and post nasal drip. I had an extreme cough. I wen to the urgent care and got a PCR covid test which was negative/.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/24/2020,4.0,PUB,"Was taking Sudafed, using cough drops and cholraseptic spray",none reported,"Chronic back pain, herniated disc",,Sulfa,"['COVID-19', 'Cough', 'Oropharyngeal pain', 'SARS-CoV-2 test negative', 'Upper-airway cough syndrome']",1,PFIZER\BIONTECH,IM 931490,PA,30.0,M,"Low grade temperature 99.4F-100.3F, myalgias",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,None,None,None,,None,"['Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931491,NJ,65.0,F,"Mild dizziness few minutes after I got the vaccine. I was advised to stay for few more minutes, vital signs checked, drank water, ate something. Dizziness went away after 30 minutes. Severe injection site pain the night of injection warm compresses done. Next day, ( Jan7,2021 )woke up at 4 am with body aches especially on my lower extremities headache, weakness and fever reaching 102.7. Started taking Tylenol 1000 mg. Symptoms were not relieved after 6 hours, but became more intense. Continued taking Tylenol every 6 hours round the clock until the next day, (1/8/21). Symptoms subsided but still w/ manageable headache and weakness. Symptoms subsided",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,none at the time,none,"type II diabetes , hyperlipidemia",,"penicillin, macrobid","['Asthenia', 'Dizziness', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 931492,CA,22.0,F,"Fever (101.5�), chills, muscle aches, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,MIL,,,,,,"['Chills', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931493,PA,43.0,F,"warm, redness, itching, tenderness on left arm at the injection site 7 days after 1st dose of vaccine. no other symptoms previously except arm pain the fist two days after vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,SYR 931494,TN,40.0,F,"11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE IS 68), BY 11:45 TIGHTNESS IN CHEST AND NECK, HEARTRATE STILL 125 RANGE, NOON: BP 154/75 (MY NORMAL IS 96/58) AND HIVES 12:10 BENADRYL (25MG) GIVEN 12:25: BP 163/78 AND ALL OTHER SYMPTOMS STILL PRESENT 1:00 SECOND BENADRYL (25MG) GIVEN 1:11: BP 158/78 1:45 HEARING TURNED MUFFLED MOVED DOWNSTAIRS TO ER SECTION AT HOSPITAL GIVEN STEROIDS, PEPCID AND WATCHED FOR ADDITIONAL TIME ON 1/9/21: STILL ON BENADRYL AND STEROIDS: WOKE UP AT 8:00 AM SORE ARM AND SLIGHT HEADACHE, 9:00 RED SPLOTCHES ON FACE, NECK AND CHEST, 11:30AM ON 1/9/21: TIGHTNESS IN CHEST AND NECK CONTINUING STEROIDS AND BENADRYL",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"hydroxychloroquine, celebrex, xiidra",none,sjogrens disease,,"amoxicillin, wasps","['Chest discomfort', 'Erythema', 'Headache', 'Heart rate increased', 'Hypoacusis', 'Muscle tightness', 'Paraesthesia oral', 'Pharyngeal paraesthesia', 'Rash macular', 'Urticaria']",1,PFIZER\BIONTECH,SYR 931495,OK,50.0,F,"01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and head congestion/sinus congestion, eyes hurt and bright red. 07:00am temp 99, took Tylenol 1000mg. 10:00am weakness and severe body aches and difficulty getting out of bed and almost fell several times and reported skin hurt. 2:57PM temp 102.7, took Tylenol 1000mg and Motrin 800mg , 06:00pm temp 100.4 took another 1000mg Tylenol and continued with symtpoms through the night and woke up around 3:30am 01/09/2021 soaking wet with sweat. 01/09/21 1:50pm continues with mild body aches and moderate headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Metoprolol 25mg Q day, Omeprazole daily, Benadryl 25mg at nigh, Nicotine patch 7mg - last wore 01/06/21, Stress away roll on essential oil,",none,"PVC's, Kidney stones-Chronic",,"Zithromax, no food allergies, no product allergies","['Asthenia', 'Body temperature increased', 'Eye pain', 'Head discomfort', 'Headache', 'Mobility decreased', 'Nasal congestion', 'Nausea', 'Ocular discomfort', 'Pain', 'Pain of skin', 'Peripheral swelling']",2,PFIZER\BIONTECH,IM 931496,NJ,49.0,F,"Localized reaction, arm being red, swollen and hot 7 days after receiving vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/08/2021,9.0,SCH,"Biotin supplement, probiotics",None,History of Acute Pulmonary Sarcoidosis,,Peniciilin,"['Erythema', 'Local reaction', 'Peripheral swelling', 'Skin warm']",1,MODERNA,IM 931497,TX,48.0,F,swelling/ numbness inside of jaw,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,lisinopryl 25 mg,none,high-blood pressure,,none,"['Hypoaesthesia', 'Swelling face']",UNK,MODERNA, 931498,TX,38.0,F,"Swollen, tender, red rash",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PUB,Bystolic 2.5 mg Balcotrol birth control,No,"Aortic stenosis, heart disease",,No,"['Rash erythematous', 'Swelling', 'Tenderness']",1,MODERNA,SYR 931499,PA,29.0,F,"Redness, swelling, warmth of injection site Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Nasonex, Nuvaring",None,None,,None,"['Fatigue', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth']",2,PFIZER\BIONTECH,IM 931500,CA,41.0,F,Hives all over body,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,None,No,No,,Yes,['Urticaria'],1,PFIZER\BIONTECH, 931501,GA,47.0,F,"Fever, chills, fatigue, muscle aches. I felt like I had the flu and was in bed all day. I was down for the count. This is completely unlike me. Not only am I not prone to being sick in general, but I've never had an adverse reaction to a vaccine. I am feeling much better today, so it was short lived, only about 24 hours, thank goodness. I'm still not 100% back to normal, but I am much better today. It's been 45 hours since my vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PUB,"Nortriptyline, Nortrel",,,,,"['Chills', 'Fatigue', 'Malaise', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 931502,KY,42.0,F,Lymphadenopathy of left axilla and left side of neck,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Cymbalta Ambien Crestor Metformin Norvasc Vitamin D Singulair Zyrtec,None,DM2 Meningioma Hypertension Hyperlipidemia Kidney stones,Flu vaccine,"Morphine, Percocet, tegretol",['Lymphadenopathy'],1,PFIZER\BIONTECH,IM 931503,WI,48.0,F,"Short of breath, flushed, warm and cold shaky, a little hard to breath, little tight in the chest "" I have asthma too too hard to tell the difference"" Tearful, skin felt clammy.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,OTH,,,,,noknown allergies,"['Chest discomfort', 'Cold sweat', 'Dyspnoea', 'Feeling cold', 'Feeling hot', 'Flushing', 'Tearfulness', 'Tremor']",2,PFIZER\BIONTECH,IM 931504,KY,49.0,F,Fever and body aches occurred about 10 hours after I received the second dose Fever ranged from 101.8 - 100.4 for about 24 hours Treated with Tylenol 650mg every six hours for a total Of three doses,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Mirapex,None,Restless leg,,Bactrim,"['Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931505,WA,52.0,F,"Very sore arm day 1, dizziness and fatigue day 2, extreme dizziness, fatigue, sore throat day 3.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Levothyroxine Cymbalta Otezla Estradiol,Eosinophilia Lichen planar pilaris,Eosinophilia with occasional Eosinophilic gastroenteritis flares requiring steroid treatment - last hospitalization 4 years ago. autoimmune lichen planar pilaris - frontal fibrosing alopecia osteoarthritis,11/05/1993 MMR booster: Lymph node reaction and rash,Eggs Linzess Amitiza Welbutrin Stadol Demerol,"['Dizziness', 'Fatigue', 'Oropharyngeal pain', 'Pain in extremity']",1,MODERNA,IM 931506,CO,60.0,F,Severe cramping -bilateral lower legs,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Vit C & D, Fish oil, Red Yeast, Aspirin 81 mg",none,none,,Citrus,['Muscle spasms'],UNK,MODERNA,IM 931507,NY,62.0,F,8 hours after vaccine I experienced stomach pain and nausea. I then became very ill and extremely weak. I was laying on floor. Very difficult to talk and very dizzy. Unable to walk. Called 911 and went to ER. Had chest pressure and cardia work up was done. Dx wi ST elevation.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,Lord attain Trazadone,No,No,,No,"['Abdominal pain upper', 'Asthenia', 'Cardiac stress test', 'Cardiovascular evaluation', 'Chest X-ray', 'Chest discomfort', 'Dizziness', 'Electrocardiogram ST segment elevation', 'Gait inability', 'Malaise', 'Myocardial necrosis marker', 'Nausea', 'Scan myocardial perfusion', 'Speech disorder']",1,MODERNA,IM 931508,OH,39.0,F,"My stomach was hurting, almost felt like an ulcer last night (day I received the vaccine.) My stomach still hurt this morning until about 11:30am, and now I have felt nauseous, absent minded, and lethargic all day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,Nexplanon,"Within the same week, I had a cough and cold. COVID test was negative and symptoms were resolved by the time I received the vaccine.",I am overweight- I weigh 210 and am 5ft 9in,,None,"['Abdominal pain upper', 'Daydreaming', 'Lethargy', 'Nausea']",1,MODERNA,IM 931510,IN,45.0,F,"I had no problems at the time of shot at 1PM. By 6PM, my arm hurt and I took 400mg ibuprofen. That night, I woke up with cold, teeth chattering, and body aches. I think I took ibuprofen around 2AM. I was okay to help get kids ready for school at 7:30AM and eat breakfast. I started feeling bad again and rested on the couch all morning. I took 600mg ibuprofen around noon. Around 1PM, my husband took my temperature at 101.6. I eventually had a few bites crackers and cheese. Felt a little better in the evening. Woke up through the night with seating again. By this morning (Saturday), I feel fine. Maybe tired from the events of Friday and a little sore, but much better. I did not call a doctor. I did have covid - tested positive November 6th. I was trying to time so my second dose was 90 days post my diagnosis.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Multivitamin,"On December 20th, I was sick one night with upset stomach. Don't know the cause, but suspect I just ate something bad at McDonald's or a small family gathering.",None. I am healthy.,,No,"['Body temperature increased', 'Chills', 'Malaise', 'Pain', 'Pain in extremity']",1,MODERNA,IM 931511,CA,64.0,F,"Within 5mins of shot numbness in both hand and both feet. With minutes she couldn't breath. B/P 180/97. Took Allergy meds and they sent her to urgent care same day. At 7pm face was swollen. She took a pill and went to bed. Now feels nausea, loss of appetite for a week.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,WRK,Metformin,no,no,,lidocaine,"['Decreased appetite', 'Hypoaesthesia', 'Nausea', 'Swelling face']",1,MODERNA,SYR 931512,OK,61.0,F,"01/08/21 02:30am on set of headache, 01/08/21 05:15am nausea Headache, called in for work due to this being so bad, 01/08/21 08:54am hip pain/throbbing, took motrin. reported difficulty to bear weight, stayed in bed all day. 01/09/20 01:00pm reports much improved continues with slight pain today, but able to ambulate and function without problems.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"D3, Biotin, Premarin, Celexa, Norvasc, Prevacid",none reported,HTN,,"Sulfa, Ceftin, no food or product allergies","['Arthralgia', 'Gait disturbance', 'Headache', 'Impaired driving ability', 'Nausea']",2,PFIZER\BIONTECH,IM 931514,MT,64.0,F,"Developed shingles on right side at waist. Pain, nausea, ltching",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,01/01/2021,15.0,WRK,"Antidepressants, vitamins, fish oil, baby aspirin, lorazepam.",None,"Overweight, depression, anxiety, heart stent, total knee replacement (Right)",,"Mold,","['Herpes zoster', 'Nausea', 'Pain', 'Pruritus']",1,PFIZER\BIONTECH,SYR 931515,TX,51.0,F,"After 20 minutes my heart started to race and pound in my chest, I was flushed and had a dry mouth. I sat and monitored what was happening and then notified the staff that it was not improving. I was directed to go to the ER for further evaluation and went. They monitored me and it resolved after about 3 hours and went home. No other issues occurred.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,None,,None,"['Dry mouth', 'Electrocardiogram', 'Flushing', 'Palpitations']",2,PFIZER\BIONTECH,IM 931516,OH,42.0,F,"High fever, chills, aches, weakness, fatigue, headache, arm soreness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Effexor, mirtazapine, klonopin",Covid 19 positive test on December 13 with symptoms,No,,No,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA,IM 931517,ME,34.0,M,"Numbness of the tongue, lips, and soft palate",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,,,,,,"['Hypoaesthesia oral', 'Palatal disorder']",1,MODERNA,IM 931519,IN,52.0,F,"Mild headache, intermittent,mild arm pain, intermittent...tylenol 500mg decreases the headache and minimizes the arm pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Claritin, lexapro 10mg, singular 10mg, vit d3, vit b complex, vit c, triamterene-hctz 75-50 mg",None,Allergies to cats dogs and seasonal,,Penicillin allergy.seasonal allegies,"['Headache', 'Pain in extremity']",1,MODERNA,SYR 931520,VA,55.0,F,"Fever 100.4 on spite of Tylenol, back ache , headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,OTH,"Jardiance, aspirin ,oxybutin, Crestor , metformin",Recent covid infection,"History of asthma, prediabetes , osteoarthritis, History of MI 2009,",,"Zofran, sulfa, penicillin, lasix","['Back pain', 'Headache', 'Pyrexia']",1,MODERNA,IM 931521,VA,53.0,M,"Chills, muscle aches, joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,WRK,Rosuvastatin Baby aspirin Lisinopril Brilinta Vitamin B complex Lyteine Vitamin D3,None,RCA stenosis with single coronary stent,,Penicillin Sulfa,"['Arthralgia', 'Chills', 'Myalgia']",2,PFIZER\BIONTECH,IM 931522,DC,63.0,M,"Fever, body pain, joints pain, diarrhea, swelling and redness on injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PHM,"Amlodipine, Lunesta, Advair, Albuterol Inhaler",,"Asthma, post-nasal drip",Shingles,None that I know,"['Arthralgia', 'Diarrhoea', 'Injection site erythema', 'Injection site swelling', 'Pain', 'Pyrexia']",UNK,MODERNA, 931523,IN,59.0,F,soreness and stiff yat the die if injection for 2 days took tylenol to treat pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,none,none,,"topical neomycin -severe hives requiring steroids, shellfish - rash","['Injection site pain', 'Musculoskeletal stiffness']",UNK,PFIZER\BIONTECH, 931524,IN,35.0,F,Inflamed lymph node along the left clavicle along with tenderness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Estrogen EEMT; Protonix; Lexapro,None,Obesity,"Flu Vaccine, same reaction",Flu Vaccine,"['Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,SYR 931525,WA,44.0,F,"Swollen/ tingly feeling in lips, tongue and cheeks as well as tingling in legs and arms, started about 1 minute after injection. Was monitored on site by EMT for 45 minutes. It did not seem to get much worse so, went home and took Benedryl. About 1 hour later symptoms started to subside. Next day, sore arm and still have a strange feeling in my tongue and lips. Teeth feel a little numb or swollen. Feels like I have lost some of my sense of taste on my tongue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,UNK,"Zyrtec daily, Flonase, Vit. D, Vit. C, Probiotics, Elderberry, Nettles",,,,"year round allergies, no known food allergies","['Ageusia', 'Feeling abnormal', 'Lip swelling', 'Pain in extremity', 'Paraesthesia', 'Paraesthesia oral', 'Swelling face', 'Swollen tongue']",UNK,MODERNA,SYR 931526,TN,48.0,F,"Arm was sore for 3 days, then fine. On 1/7/20, arm was sore at bedtime. On 1/8/20, arm was sore and hot to touch. Stem also had large red blotches that looked like and allergic reaction. Became itchy evening of 1/8/20. Benadryl was taken. Today, 1/9/20, redness and soreness is still there. Redness is more solid instead of broken and splotchy. Red Area is about the size of a fist.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,"Trintellix, Vitamin D3, Vitamin C, Zinc, Elderberry, Probiotic",None,None,,None,"['Erythema', 'Pain in extremity', 'Pruritus', 'Rash macular', 'Skin warm']",UNK,MODERNA,SYR 931527,CA,27.0,F,Moderna COVID-19 Vaccine EUA - Swollen and tender lymph node in armpit of same arm of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/09/2021,6.0,PUB,Norethindrone Acetate and Ethinyl Estardiol Tablets 1mg/0.02mg,,,,,"['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,SYR 931528,IN,53.0,F,"12 hours post injection- fever of 101.8, body aches, headache, fatigue. Lasted about 23 hours before fever was back to normal. Still have fatigue and weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Trazadone, verapamil, spironolactone, prempro, meloxicam",None,HTN,,Lisinopryl,"['Asthenia', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 931529,,32.0,F,"Per pt report, heart rate increased significantly after vaccine administration. Pt was taken to the local ER for observation. Was able to return home same day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,,,,,,['Heart rate increased'],1,MODERNA,IM 931530,WA,38.0,F,I received Moderna #037K20A COVID 19 vaccine yesterday and 3 hrs after that I developed tingling and numbness in my arm. I then developed a swelling and intense pain. There is area of induration and erythema around the vaccine injection site. I have been using Ibuprofen every 6 hrs for pain and applying ice pack which is helping some with pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,OTH,multivitamins,none,none,,Meloxicam,"['Hypoaesthesia', 'Injection site erythema', 'Injection site induration', 'Pain in extremity', 'Paraesthesia', 'Peripheral swelling']",1,MODERNA,IM 931531,CA,36.0,F,"9:53 am - 5 minutes after receiving vaccine, pt reports feeling chills and palpitations. 10:04 am evaluated by EMS BP 122/87 P 78 10:55 am pt requesting to be transported to Hosp for evaluations.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PUB,no,,,,"Aspirin, Keflex","['Chills', 'Palpitations']",1,MODERNA,IM 931532,TN,66.0,F,"45 minutes after vaccination, I had swelling of my upper lip, mouth, face cheeks, eyes, forehead, scalp. At home I began taking antihistamines to reduce the swelling and itching. Symptoms continued for 8 days, reducing in severity each day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,PVT,"Synthroid, Vitamin D, Vitamin B12, Clairitin, Benadryl",none,Hypothyroidism Osteoarthritis Bursitis Vitaligo Allergies to pollen,Flu vaccines years 2016-2020 skin rash/arm swelling,Penicillin Sulfa drugs,"['Eye swelling', 'Lip swelling', 'Mouth swelling', 'Pruritus', 'Skin swelling', 'Swelling face']",1,PFIZER\BIONTECH,IM 931533,CA,31.0,M,"Sweats, chills, and adenopathy 12 hours after second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,01/08/2021,22.0,PVT,None,None,None,,None,"['Chills', 'Hyperhidrosis', 'Lymphadenopathy']",UNK,PFIZER\BIONTECH, 931535,MA,31.0,F,"sore arm 1-2 days post vaccine, exactly 1 week post vaccine (12/30/2020) rash appeared around injection site on L arm, measuring roughly 2 in. across. Initial visit to urgent care dx of allergic reaction, prescribed triamcinolone 0/5% 2x/day and antihistamine as needed. Followup visit following day, separate doctor gave dx of cellulitis to spreading area now 4 in wide and long, given rx of doxycyclin 100 mg 2x/day for 10 days. On 1/9/2021 at followup visit doctor noted cellulitis was gone but rash still persisted. Given order to stop doxy, begin course of prednisone 50mg 1x/day for 5 days. Followup if needed post course of prednisone.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/30/2020,7.0,PVT,"women's daily multivitamin, sertraline",,"family hx of type II diabetes, depression",,"dairy allergy, allergy to bactrum, sulfas, erythromycin","['Cellulitis', 'Injection site rash', 'Pain in extremity']",1,MODERNA,IM 931536,NY,59.0,F,"Jan. 8@9:30-mild soreness- left arm Jan.9@6:30 a.m.- moderate soreness- left arm Jan.9@12:30pm- achey all over + left arm soreness, mild headache Jan 9@1:45- achey all over, left arm soreness and chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PUB,"Probiotics, CoQ10, C, D, Zn, omeprazole, incruse, qvar, montelukast, rosuvastatin, lexapro, diltiazem",None,Asthma,Flu- like symtomd and left arm soreness,Sulfa,"['Chills', 'Headache', 'Pain', 'Pain in extremity']",2,MODERNA,IM 931537,FL,68.0,F,"Patient reported rash, no rash evident on exam, no itching, no trouble breathing, Patient was given 25mg Diphenhydramine, no further treatment needed",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Sumatriptan 50mg PRN ASA 81 mg,,,,Codeine Phenergan,['Rash'],1,MODERNA,IM 931538,FL,74.0,F,"Injection sight left red rash ( about 2inches 5 inches high) itches , warm to touch. Still red , itches,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PUB,No,No,Thyroid,,Penicillin,"['Injection site reaction', 'Injection site warmth', 'Rash erythematous', 'Rash pruritic']",1,MODERNA, 931539,FL,38.0,F,I had severe facial swelling that started on my left cheek and lip the morning after the vaccine. That night the swelling mover to the center of my face (mainly my bottom lip and some of my chin). Day 2 the swelling was most severe and moved to my right cheek and lip. The swelling was less the night of day 2 and even better the morning of day 3 after starting oral prednisone . Today on day four I am Almost back to normal but still some puffiness in both cheeks and bottom lip. Per my physicians advice I will be on a 5day course of oral prednisone (10mg 2x/day) The other adverse event I experienced was starting day 2 I had extreme pain and itching as well as some cyst like bumps on both my feet as well as very mild itching on my palms.They are improving on day 4 but still super itchy. I have been advised to take Benadryl as needed for that.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,Na,Na,Na,,Na,"['Lip swelling', 'Pain in extremity', 'Pruritus', 'Swelling face']",1,MODERNA,IM 931540,UT,71.0,M,"Minor! After 9 days I developed a itchy, slight, red rash on arm approximately 2cm below injection site. Size 5cm X 8cm. I am only reporting this because the clinic gave us a card to use with a smart phone to report any different occurrence. I do not have a smart phone so I am using this approach, in case you want this information.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/08/2021,9.0,PUB,"Tamsulosin, Omeprizole",None,None,,Sulfa drugs,"['Injection site reaction', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 931541,IL,22.0,F,"About one week after receiving the first dose of the Pfizer Covid-19 vaccine, I developed a rash on two fingers of my left hand that itches. I used OTC hydrocortisone cream on it, which relieved the symptoms temporarily. Rash is still present today. I received the second dose of the vaccine yesterday, 1/9/2021, in my right arm, and today I noticed the rash is spreading to my right hand. I have not had any previous adverse reactions to any other vaccine. I went to urgent care today and the nurse practitioner recommended me to take Benadryl 25 mg at night to relieve symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/23/2020,7.0,PVT,None.,None.,None.,,NKA.,"['Pruritus', 'Rash']",2,PFIZER\BIONTECH,IM 931542,IN,28.0,F,"Low grade fever, mild aches, nausea, headache, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,WRK,"Oral contraception, multivitamin, elderberry supplement, aloe Vera supplement",None,None,,None,"['Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 931543,IN,64.0,M,"Sudden onset chills, fatigue, muscle aches all over. No other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,None,None,Lumbar disc disease,,None,"['Chills', 'Fatigue', 'Myalgia']",2,PFIZER\BIONTECH,IM 931544,CA,29.0,F,"Tightness of throat, sore arm, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,Junel Fe 1.5/30,None,Obesity,,None,"['Fatigue', 'Pain in extremity', 'Throat tightness']",1,MODERNA,SYR 931545,ME,47.0,F,"High fever ( highest 102.6 within 72 hrs. ). Took Tylenol (100mg every 8 hrs and 400 mg of ibuprofen every 3 hrs starting at 10:30 pm on 1/8/21. Severe arm pain for 24 hrs. Nausea, body aches, chills, swollen and painful lymph nodes in neck, blurry vision (first 48 hrs), skin sensitivity, loss of appetite, and moderate to severe joint pain. Also some behavioral issues ( irritability, anxiety).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,PVT,None,None other than allergies,Lichen sclerosis,Extreme fatigue and sore arm after annual flu shot. Resolves in 24 hrs,"Latex, codeine, gluten, dairy, most chemicals, seasonal allergies, dust and mold allergies","['Anxiety', 'Arthralgia', 'Chills', 'Decreased appetite', 'Hyperaesthesia', 'Irritability', 'Lymph node pain', 'Lymphadenopathy', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'Vision blurred']",1,MODERNA,IM 931546,IL,44.0,F,"Patient was extremely anxious prior to vaccine. She told me she did get seizures but she took medication for it and I informed her that it would still be recommended to get the vaccine. She was visibly anxious even after vaccine. Immediately after she began crying to her friend and said she ""was just SO afraid of needles"". I told her to take some deep breaths and after a minute or two she went to the observation room. Approximately 15 minutes later she rushed back into the room looking like she might hyperventilate or have hypoglycemia (shaking, cold sweats). She sat down and I tried to calm her down. I asked someone to get her orange juice. During the next couple minutes she did not seem to be getting any better and started shaking. I requested someone call 911. Another staff was helping so I moved to get and administer an epi-pen injection. By this time the patient was not responsive, but was still breathing. I instructed staff to help move her to the floor for monitoring and if needed, cpr. She regain partial consciousness. Her breath and pulse were always present, so there was no need to begin cpr. After a few minutes EMT arrived and transported patient to local hospital. During all of this, other employees at the facility were attempting to contact family members, which they were eventually able to do. About 30 minutes later the staff informed me they had spoken to family members who were at the hospital and that she was improving, but they had not seen her yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,UNK,Not known,Unknown,"Asthma, seizure disorder",,None reported,"['Anxiety', 'Fear of injection', 'Loss of consciousness', 'Tremor']",1,PFIZER\BIONTECH,SC 931547,AK,50.0,M,headache and nausea for 12 houre,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/07/2021,2.0,OTH,,,,"shingles vaccine, 2 doses, November",,"['Headache', 'Nausea']",1,PFIZER\BIONTECH,IM 931549,FL,72.0,F,"Developed a rash about 12 hours - approx 1AM) after the injection (1PM) which started on right side of my face and by morning also had a bit on my arms, shoulders. Rash has looked gone and not affected me during part of some days, then will flare up later at night and seems to be in places at times, like legs, other side of my face and then gone. Not particularly itchy, mostly a feeling of irritation and rash on right side of face feels tight, like when you have a sunburn.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,UNK,"Levoththyroxine, Spironlactone, Vitamin D3, Tylenol","Sinus issues, possible infection","Heart disease, high blood pressure, sinunitis, hyperthyrodism, hyperparathuyroidsim , hyperaldosternoism, asthma",,"Sulfa, Penicillin, bee stings ( thought not for past 12 years), latex, Cortisone, Anti-Inflammatories, Betadine, Latex, Hydralazine, most antibiotics","['Rash', 'Rash erythematous', 'Skin irritation']",1,MODERNA,UN 931550,GA,56.0,F,"Moderna COVID-19 Vaccine EUA at clinic Within 10 minutes I became extremely light-headed, foggy, and experienced severe headache. Returned to the site to be monitored by the doctor. Was advised to take a Benadryl (within 30 minutes of injection). The head issues continued in waves for about 2 hours. My throat felt tight, but never closed off. Once home I experienced a fever of 100 for approximately 2 hours. Remedied by acetaminophen. Slept well and woke with no further symptoms except slight injection site soreness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,"Estrogen (estradol), Unithroid, Vit D, Hair Skin Nail suppl, Culturelle probiotic Benadryl (25 mg) taken 30 minutes after vaccine",None,"migraines, hypothyroidism",,None,"['Dizziness', 'Feeling abnormal', 'Headache', 'Injection site pain', 'Pyrexia', 'Throat tightness']",1,MODERNA,IM 931551,CA,32.0,F,at 11:09 am - minutes after receiving vaccine pt reports feeling chills and palpitations. Pt has a history of angioedema to unknown cause. 11:09 BP 143/95 P 71 11:15 BP 134/81 P 84 11:20 129/83 P 69 11:27 120/81 P 70 pt reports feeling better and declines call to EMS,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PUB,oral birth control,Anxiety,,,,"['Chills', 'Palpitations']",1,MODERNA,IM 931552,IL,29.0,F,"I noticed my heart rate was very high and bounding, and I felt very shaky. I took my heart rate at home with a pulse oximeter and it was 150bpm. I went to the emergency room where they did an EKG, labs, and chest xray; all were within normal limits. I was observed for a few hours and sent home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,IUD,,,,Sulfa,"['Blood magnesium normal', 'Blood thyroid stimulating hormone normal', 'Chest X-ray normal', 'Electrocardiogram normal', 'Full blood count normal', 'Heart rate increased', 'Metabolic function test', 'Nervousness', 'Palpitations', 'Troponin normal']",2,PFIZER\BIONTECH,IM 931553,GA,48.0,M,"Onset of shaking chills, dysasthesia, and myalgias lasting ~20 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,WRK,,"COVID, diagnosed 10/28/2020",,,NKDA,"['Chills', 'Dysaesthesia', 'Myalgia']",1,MODERNA,IM 931554,MI,30.0,M,"18h: Dissociation (mild), fatigue 24h: nasal congestion, fatigue 26h: fever, chills, headache, nasal discharge and congestion, fatigue, nausea 30h: difficulty sleeping, headache, fatigue, nausea (ibuprofen 800mg, acetaminophen 1000mg, pepto bismol caplets 2) 36h: fatigue, joint pain (hip) 42h: mild fatigue, joint pain (hip)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Escitalopram, atorvastatin",None,"Anxiety, depression, obesity, hyperlipidemia, obsrtuctive sleep apnea",,None,"['Arthralgia', 'Chills', 'Dissociation', 'Fatigue', 'Headache', 'Insomnia', 'Nasal congestion', 'Nausea', 'Pyrexia', 'Rhinorrhoea']",2,PFIZER\BIONTECH,IM 931555,GA,61.0,F,"Extreme skin sensitivity to torso (chest & back) on left side parallel to the injection site, shingles type sensitivity without a rash or redness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/01/2021,10.0,PVT,"Metformin, norvasc, levothyroxine, zocor, Zyrtec, multivitamin, amitriptyline, robaxin, calcium chews",None,"Diabetes, htn",,Quinolones,['Sensitive skin'],1,PFIZER\BIONTECH,IM 931556,PA,29.0,F,"This is my second pregnancy and at the time of my vaccination, I was 32 weeks 6 days gestation with an estimated delivery date of 2/15/21. I tolerated the vaccine well initially with only a very minor sore arm the day after the vaccine. On 12/31/2020 (4 days after vaccination), I felt muscle fatigue around my hips and buttocks as well as significant fatigue. It seemed to improve over the course of the day and was not very noticeable for the next few days. On 1/4/21 (8 days after vaccination), my muscle fatigue in my hips, buttocks, thighs, and hamstrings bilaterally became very significant, preventing me from doing some activities that I had planned. I also had generalized fatigue. On 1/5/21, I had similar symptoms, but the muscle fatigue also began to include my shoulders bilaterally. 1/6/21, the muscle fatigue also included my neck and I was physically exhausted. 1/7/21 I started to note some improvement, and I also saw my OB who did bloodwork but also did suspect a possibly delayed reaction to my vaccine. Today (1/9/21) I am still experiencing muscle fatigue, but it does seem to be improved from several days ago.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/31/2020,4.0,PVT,"Prenatal vitamin, miralax",None,None,,None,"['Exposure during pregnancy', 'Fatigue', 'Full blood count normal', 'Haemoglobin decreased', 'Loss of personal independence in daily activities', 'Metabolic function test normal', 'Muscle fatigue', 'Pain in extremity']",1,MODERNA,IM 931557,IN,50.0,M,Hyperglycemia with polyuria. Peak CBG 300 postprandial first night but fasting CBG still 177 at 48hr,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,Atorvaststin Metformin Januvia,None,T2DM Hyperlipidemia,,None,"['Full blood count abnormal', 'Hyperglycaemia', 'Polyuria']",2,PFIZER\BIONTECH,IM 931558,AR,47.0,F,"7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation",Not Reported,,Yes,Yes,1.0,Yes,U,12/22/2020,12/30/2020,8.0,PHM,None,None,None,,None,"['Cerebrovascular accident', 'Computerised tomogram', 'Hypercoagulation', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Laboratory test', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging neck', 'Scan with contrast']",1,MODERNA,IM 931559,FL,36.0,F,"Fever and chills starting 5 hours after dose, joint pain, myalgia, anxiety, palpitations, loss of appetite, fatigue, abdominal pain, dizziness, near syncope, headache, insomnia, arm soreness, tingling and numbness in my face and mouth about 10 hours after dose and lasting about 30 min, taking ibuprofen one tablet q6 hours for fever and pain. 26 hours dose symptoms are improving",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,None,,None,"['Abdominal pain', 'Anxiety', 'Arthralgia', 'Chills', 'Dizziness', 'Headache', 'Hypoaesthesia', 'Insomnia', 'Myalgia', 'Pain', 'Pain in extremity', 'Palpitations', 'Paraesthesia', 'Paraesthesia oral', 'Presyncope', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931560,CO,55.0,F,"24 hours very sore/tender arm (felt like getting a typhoid shot) December 29, difficulty sleeping, restlessness, extreme, Fatigue all week, woke up 4 days later (January 1, 2021) with raised painful sore bumps on right side of palate,. Day two crossed midline of palate, Day three entire roof of mouth, and tip of tongue. Painful to drink, eat, and brush teeth.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/01/2021,4.0,PVT,"Tramadol, tinazadine , MVI with iron, Iron Gluconate, Tylenol, gabapentin, Wellbutrin, Premarin, Hydroxyzine, Protonix, Rolaids, Vitamin D3, Biotin, Zyrtec D, Benadryl Lidocaine 5% topical patches, and diclofenac sodium gel as needed. P","None: Currently have c6 and c7 with a protrusion had a steriod injection at c6 &7 in November 2020, and fluid in ears r/t allergies","right should arthritis, neck arthritis, hx of gastric bypass, iron deficiency anemia , hiatal hernia",H1N1,"Garlic, Escitalopram, Acyclovir, Nickel, Morphine, and Bactrim","['Fatigue', 'Insomnia', 'Pain in extremity', 'Rash', 'Rash papular', 'Restlessness', 'Tenderness']",1,MODERNA,IM 931561,CO,30.0,M,"Friday 1/8/21 I got a bit of what i think was nerve pain or just shooting pain on the wrist of the right-arm that was not the injection arm. Then today (Sat 1/9/21) that nerve pain is gone, but I developed a worse pain (pain of 6-7 out of 10) and additionally some weakness in the left-forearm closer to my elbow than my wrist, possibly where a tendon is (the injection arm). The pain shoots down from the elbow area towards my wrist on the posterior side. I haven?t done any extraneous work or lifted anything heavy since 1-2 days before the vaccine. It?s also my non-dominant arm so I don?t use it as much as my other arm. So far I have iced it twice and taken Tylenol which has helped the pain. The arm is currently in a sling and I haven?t tried to use it since icing it the first time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/09/2021,3.0,PVT,"Montelukast, Zyrtec, Advair, Adderall IR, multivitamin, vitamin b complex, vitamin D3, famotidine, Tylenol",No acute illnesses,"Asthma, adhd, seasonal/pet allergies",,"Peanuts, tree nuts, NSAIDs","['Asthenia', 'Neuralgia', 'Pain']",2,PFIZER\BIONTECH,IM 931562,FL,49.0,F,"mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vomiting, diarrhea, itching This started at minute 13 after the vaccine administration. I have had several infusion reactions before to biologics to treat my autoimmune disease and this is how it always starts. There was nothing available at the administration place so I left and took zyrtec, benadryl and pepcid. The symptoms stopped in about 25 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,UNK,"cellcept 1000 mg bid cyclosporin 200 mg qam, 100 mg qpm plaquenil 200 mg bid paxil 20 mg daily pilocarpine 5 mg bid prednisone 2 mg daily singulair 10 mg daily sulindac 150 mg bid lisinopril 20 mg daily cardizem 250 mg daily restasis eye d",rheumatoid arthritis chronic hives high blood pressure,rheumatoid arthritis chronic hives high blood pressure idiopathic angioedema migraines secondary sjogrens syndrome,,codeine,"['Anxiety', 'Cough', 'Diarrhoea', 'Nausea', 'Oral pruritus', 'Pruritus', 'Swollen tongue', 'Tachycardia', 'Vomiting']",2,PFIZER\BIONTECH,IM 931563,NY,58.0,F,"""Pfizer-BioNTech Covid-19 Vaccine EUA. Side Effects: nausea, body aches, chills, headache, fatigue. I took Ibuprofen. Symptoms lasted for approximately 36-40 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,SEN,"Levothyroxine, multi vitamin, baby aspirin, gabapentin, estradiol and norethindrone acetate, calcium, vitamin D3,",none,Hashimoto's Hypothyroiditis (diagnosed in December 2020),,Sulfa drugs,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,IM 931564,CA,41.0,F,"Redness to injection arm, severe headache, cough, fever, pain, fogginess. Treated with Benadryl and ASA and overhang cough syrup",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,WRK,"Aspirin 325 daily, Vit D daily, melatonin 5mg daily, unasome daily",None,Melanoma 2016,,"Latex, adhesive","['Cough', 'Feeling abnormal', 'Headache', 'Injection site erythema', 'Pain', 'Pyrexia', 'Respiratory viral panel', 'SARS-CoV-2 test']",1,MODERNA,IM 931565,IN,20.0,F,"The morning after the shot, I woke up with a sore arm, temperature kept going up/rising during the day, felt nauseous, dizzy, tired, warm stomach.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Body temperature increased', 'Dizziness', 'Fatigue', 'Feeling hot', 'Nausea', 'Pain in extremity']",1,MODERNA,SYR 931566,CO,59.0,F,"chills, fever ranging from 99.2 to 100.6, extreme body aches, non stop coughing.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,OTH,"vitamins, essential oils",none,none,,"Biaxin, azithromycin, pain patch","['Chills', 'Cough', 'Pain', 'Pyrexia']",1,MODERNA,IM 931567,FL,25.0,F,"sudden sensorineural hearing loss in the right ear, audiology and ENT assessment, currently being treated with steroid medication",Not Reported,,Not Reported,Not Reported,,Yes,N,12/28/2020,01/06/2021,9.0,UNK,loloestrin,none,none,,no known allergies,['Deafness neurosensory'],1,MODERNA,IM 931569,NY,45.0,F,Fever 103.4 Nausea Vomiting Headache Chills Large welt at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Headache', 'Injection site reaction', 'Nausea', 'Pyrexia', 'Urticaria', 'Vomiting']",1,MODERNA,IM 931570,VT,25.0,F,"I walked in to received my first dose of the Moderna Covid19 vaccine at approx 12:20pm 1/7/21. The RN who was giving me my injection palpated the top of my shoulder and NOT my acromian process and administered the injection closer to the top of my shoulder, the vaccine did initially hurt more than a typical vaccine would when it was being administered but i thought that might have been normal. Approximately 1hr after receiving the vaccine my left shoulder joint started to have this pinching sensation in the anterior joint when I would raise my arm forward. The pain got progressively worse throughout the day with significantly decreased range of motion in that shoulder and significant pain in my shoulder joint. The pain was so bad it actually kept me from sleeping that night. I never had any muscular pain or any other symptoms beside the joint pain, which was alarming since it should have been administered into the muscle. I believe the vaccine my have been incorrectly injected into the shoulder joint or potentially a smaller muscle in the shoulder. The pain and decrease ROM is preventing me from doing most of my regular day to day activities. Today 1/9/21 has been a full 48hrs after receiving the vaccine and the joint pain has not gotten any better and my range of motion is still significantly decreased, which would prevent me from performing my tasks as an RN.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,None,None,None,,None,"['Arthralgia', 'Impaired work ability', 'Joint range of motion decreased', 'Loss of personal independence in daily activities', 'Product administered at inappropriate site', 'Sleep disorder']",1,MODERNA,IM 931571,MN,56.0,F,"temp 100 F , chills body aches mainly lower back ache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,none,none,none,shingles,none,"['Back pain', 'Chills', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 931572,NY,24.0,F,Polyphagia and Mild Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,none,Migraine Disorder,Surgically Absent Gallbladder IHH ( Remission) LP Shunt ( Ligated) Migraine Disorder,,Tetracycline and Doxycycline,"['Headache', 'Hyperphagia']",1,MODERNA,IM 931573,NC,42.0,M,"Vasovagal syncope about 5 minutes after shot. Symptoms lasted about 5-7 minutes. Hypothensive. Diapharetic, Nausea,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/06/2021,5.0,OTH,,,,,Sulfa,"['Blood glucose normal', 'Bundle branch block right', 'Electrocardiogram abnormal', 'Hyperhidrosis', 'Hypotension', 'Nausea', 'Syncope']",1,MODERNA,SYR 931574,VA,25.0,F,"Initially, there was soreness, swelling, and redness (all around upper arm - a bit below deltoid) around injection site over the course of a few days. The area was warm to the touch compared to the rest of the arm. All symptoms went away after 5 days. Exactly 7 days later, a little bit of the soreness came back and there was a redness marking the size of a 50 cent coin. The next day, the soreness grew and the redness spread and the area became warm to the touch again. I talked to a doctor over video chat to talk about what I should do - I was advised to use an ice compress, which I did a few times on and off. The next day (today), redness spread, but soreness and feeling warm to the touch stayed the same. I went to urgent care and was given 7-day antibiotics and told to use Claritin/Zyrtec to lower my histamines. If anything progresses, I should let the provider know.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PUB,No,No,No,,None that I know of,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 931575,,27.0,F,"chills, muscle pain, join aches, elevated heart rate, weakness, headache @ 12 hours after injection took 650mg tylenol, able to fall asleep awoke again with sweats (did not take temperature) able to fall asleep, slept a total of 18 hours still with headache, weakness, fatigue on wakening, took 325 mg tylenol and 200 mg advil symptoms resolved approximately 25 hours after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,UNK,150mg sertraline,none,Asthma,,tetracyclines,"['Arthralgia', 'Asthenia', 'Chills', 'Headache', 'Heart rate increased', 'Hyperhidrosis', 'Myalgia', 'Somnolence']",2,PFIZER\BIONTECH,IM 931576,FL,42.0,F,My right upper eye lid kept twitching for 5 minutes then it stopped. Then after 2 hours kept twitching for ten minutes then it stopped.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Metformin,Diabetes Gerd,,,Mild allergy to dust might and roaches and pecan,['Blepharospasm'],1,MODERNA,IM 931577,TX,50.0,F,"Since administration - Chest pain, Shortness of breath, blurred vision, headache, nausea, and chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Chest pain', 'Chills', 'Dyspnoea', 'Headache', 'Nausea', 'Vision blurred']",2,PFIZER\BIONTECH,IM 931578,TX,45.0,F,"After 15 minutes patient reported chest pressure which increased with inspiration. could not report rating on pain scale. Initial BP with complaints was 168/138. HR 88, RR 16, 98 o2sat, Temp 98.8. Follow BP 137/85 5 minutes later .Sent to ED at 12:53. 12 lead EKG, Normal sinus rhythm, no ischemia. CXR negative. Shortly upon arrival in ED chest pressure resolved with out further intervention. Pt discharged to home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,UNK,Lisinopril 10mg qday,No,HX. HTN,,NKDA,"['Blood pressure increased', 'Chest X-ray normal', 'Chest discomfort', 'Electrocardiogram normal', 'Respiratory rate increased']",2,PFIZER\BIONTECH,IM 931579,NE,48.0,F,"fever, chills, arm pain, muscle aches, severe headache,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"tylenol, calcium, multivitamins",none,none,,"penicillin, sulfa, codeine","['Chills', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931580,OH,21.0,F,"Patient reported having a ?pepper? taste in the mouth about 3 minutes after vaccine administration. Patient thereafter reported having a tingling sensation in the mouth and lightheadedness about 6 minutes after vaccine administration. Patient laid down and vital signs were taken; BP-126/68, HR-100. Patient drank 1/2 of 16oz. bottle of water and a 12oz of a sports drink. Vitals were rechecked 13mins after the first set; BP- 120/62 HR- 64. Patient reported feeling better afterwards I.e lightheadedness had subsided and no tingling sensation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,OTH,Concerta (daily) Sertraline (daily),,Postural orthostatic tachycardia syndrome Eosinophilic esophagitis ADHD,,Peanuts -anaphylactic reaction Dairy,"['Dizziness', 'Dysgeusia', 'Paraesthesia oral']",UNK,MODERNA,IM 931582,WA,57.0,F,Pt vaccinated with Moderna COVID vaccine shot number 1. scratchy throat started 5 minutes afterward. Tongue was tingling. throat was dry. no stridor or wheezing. initial BP 128/82 pulse of 80 )2 sat of 100%. normal mucous membranes no wheezing initially no rash. then complained her ears were hot. Shortly thereafter developed a flush on the upper chest and face and ears. 1/9/2021 11:59 AM Patient light headed. Ears feeling hot. 1/9/2021 12:02 PM patient has flushing of face and upper chest. Denies itching. 1/9/2021 12:03 PM patient reports itching of neck. blood pressure 118/78 1/9/2021 12:13 PM Sitting up Flushing is slightly better 1/9/2021 12:41 PM Sitting up Flushing has resolved. 130/70 Pulse 52 96% sat Patient is feeling back to normal Discharged to home OK to get second dose. the patient did take 10 mg Claritin about 90 minutes before the vaccination. she takes Claritin daily . we have sent her home no symptom s,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Amour Thyroid Celexa Vit C Vit D Glucosamine,none,low thyroid osteoarthritis anxiety - takes celexa,,"Sulfa :Rash , Penicillin Rash Amoxi Rash Kelfex Rash Cirpo Sent to hospital eye red and body flushing.","['Dizziness', 'Dry throat', 'Ear discomfort', 'Flushing', 'Oropharyngeal discomfort', 'Paraesthesia oral', 'Pruritus']",1,MODERNA,IM 931583,NY,27.0,F,"10 minutes after getting shot, my lips started swelling and tingling and itching. Hives/ Redness on my face 30 minutes after- throat started itching Treatment- given Benadryl, Pepcid, Steroid in Emergency Room and was observed from 10:30ish until 2:15p",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,Xyzal Sharobel Vitamin D Prevident Toothpaste Differin Gel,None,None,Xolair- allergy shot injection to prevent hives in 2017,"Medications- Augementin, Minocycline Food: Tree Nuts","['Blood test', 'Erythema', 'Lip pruritus', 'Lip swelling', 'Paraesthesia oral', 'Throat irritation', 'Urticaria']",1,MODERNA,SYR 931584,GA,29.0,M,"Injection site pain, mild Headache, moderate Chills, mild Muscle and joint pain, moderate",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PUB,Metoprolol Paroxetine,None,Hypertension,,Ceclor Trazodone,"['Arthralgia', 'Chills', 'Headache', 'Injection site pain', 'Myalgia']",2,PFIZER\BIONTECH,IM 931585,TN,75.0,F,Moderate metallic taste in the back of mouth No treatment needed. Disappeared after about an hour.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,UNK,"Omeprazole, famotidine, Simvastatin, atenolol, amlodipine, low dose aspirin. acetominophen. Vitamin D3, multi vitamin, probiotic, tumeric, CoQ10, chelated magnesium",None,"HBP controlled, GERD",,"raspberries, adhesive",['Dysgeusia'],1,MODERNA,IM 931586,WI,57.0,F,"Headache began about 5 minutes after injection and lasted until the next day. About 10 hours after receiving the vaccine, I was awakened by intense pain in the tragus of both ears, as if they were in a vice grip. I finally took acetaminophen which mostly resolved it, but I continued to have similar, intermittent pain over the next 2-3 days. It has now resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"Celebrex, Black cohosh, multivitamin",none,none,,Erythromycin,"['External ear pain', 'Headache']",1,PFIZER\BIONTECH,IM 931587,NY,28.0,F,"myalgia, chills, headache, and fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,Junel,none,none,,,"['Chills', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931588,,51.0,F,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Inappropriate schedule of product administration'],UNK,PFIZER\BIONTECH, 931589,MO,58.0,M,"Fatigue/malaise, aching joints, low-grade fever, slight headache--all began approx. 23 1/2 hours after vaccine. Chills began approx. 36 hours after vaccine. Extra-strength acetaminophen (2 tabs) taken approx. every six hours during daytime hours when symptoms began. Symptoms continued for approx. 50 hours after they initiated.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,SEN,Daily multivitamin; Vit D3 1000IU daily,"None, though did test positive for COVID-19 Oct 26, 2020.",Exercise-induced asthma,,NKDA,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Malaise', 'Pyrexia']",1,MODERNA,IM 931590,NY,35.0,F,Two days after I had a red hard raised hot lump. Treated with ice and Advil. Fully went away. Last night one week one day post I have a raised red itchy rash,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,UNK,Lisiopril. Lexapro. Birth control. Multi vitamins,Covid tested for symptoms 12/11. Negative,Htn,,Allergy to Lori tab,"['Erythema', 'Induration', 'Mass', 'Rash erythematous', 'Rash papular', 'Rash pruritic', 'Skin warm', 'Swelling']",UNK,MODERNA, 931591,IN,33.0,F,"Headache, extreme lethargy, full body hives, eyes swollen . Symptoms lasted for about 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,Sertraline,None,None,,Benedryl,"['Eye swelling', 'Headache', 'Lethargy', 'Urticaria']",UNK,PFIZER\BIONTECH, 931592,CA,38.0,M,Gout like symptoms upon wakening. Swollen painful toes on right foot.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Statin,None,None,,None,"['Pain in extremity', 'Swelling']",UNK,MODERNA, 931593,MD,48.0,F,Dizzy Headache Nauseous,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PUB,"Lamictal, Trazadone, Trileptal, Synthroid, Trokendi, Oxycodone, Gabapentin, Modafinil, Motrin.",,Fibromyalgia Herniated discs Bipolar Migraines,,"Cipro, Cymbalta.","['Dizziness', 'Headache', 'Nausea']",1,MODERNA,SYR 931594,WI,53.0,F,"Muscle pain, joint pain, fever, chills, shortness of breath, headache, fatigue, starting the morning after the vaccination that was provided around 4:30 in the afternoon, used Tylenol for the pain and fever. Better the next day but still not well. Missed work",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PUB,,COVID positive December 13th,"Capp, asthma",,,"['Arthralgia', 'Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Impaired work ability', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 931595,CA,28.0,F,Sore arm after IM injection surrounding injection site lasting 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,None,None,None,,Sulfa,"['Injection', 'Injection site pain']",1,PFIZER\BIONTECH,IM 931596,OH,34.0,F,"Arm was bruised and tender to the touch approximately 3-4 hours following vaccine. Started feeling dizzy around 8pm on 1/7/21. Took PM meds and went to bed. Awoke around 3am with a temp of 103, joint aches, muscle aches, chills, congestion, eyes very dry and itchy, severe headache/migraine with photosensitivity, fatigue on 1/8/21. Left arm was swollen, hot to the touch and very tender to move it. Took Tylenol and Benadryl to help relieve symptoms. Put a heating pad on injection site. Felt about the same all day so I rested. Went to bed around 10pm on 1/8/21. Woke up around 4am on 1/9/21 and my temp was 99.7 prior to taking any meds and after about 20 minutes of being out of bed. On 1/9/21 I still have arm tenderness and bruising, fatigue, headache, left eye redness to upper eyelid with swelling, temp has been running at 99.7 and it?s currently 4pm EST.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,"Biotin 10,000mg PO AM Potassium 90mcg PO BID Mag-ox 400mg PO BID MTV PO QAM Apple cider vinegar 400mg PO QAM Acidophilus PO BID Vit B12 1,000mcg PO QAM Vitamin B complex PO QAM Simethicone 80mg PO QID PRN Imitrex 50mg PO daily PRN (was not",No prior illness prior to vaccine.,Migraines. That?s it.,,Bactrium Keeflex Sulfa,"['Arthralgia', 'Body temperature increased', 'Chills', 'Contusion', 'Dizziness', 'Dry eye', 'Eye pruritus', 'Fatigue', 'Headache', 'Migraine', 'Myalgia', 'Peripheral swelling', 'Photosensitivity reaction', 'Respiratory tract congestion', 'Sleep disorder', 'Swelling of eyelid', 'Tenderness']",1,MODERNA,IM 931597,FL,66.0,M,FEVER OF 101.3�,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,OTH,"TIVICAY, PREZISTA, RITONAVIR, CRESTOR TRICOR, ZETIA, 84 MG ASPIRIN, NIACIN, B12, D3","HIV,","HIV, HEART",,None,['Pyrexia'],1,MODERNA,SYR 931598,FL,45.0,F,"At about 15 minutes post vaccination individual experienced a feeling tongue was swollen. Initial vital signs stable and she self-reported to vaccination staff. Provider was called, and 0.3 mg Epinephrine via Epi pen was given. On-base emergency response EMTs and command post activated. Symptoms were slight hoarseness, salivating, difficulty pronouncing words, and flushed. She felt her cheeks were starting to swell. After the one dose epinephrine she felt swelling start to resolve and symptoms improving. She was transported via EMS to hospital where she reports back to us IV hydration and is anticipating release with a clear airway and normal vital signs.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,MIL,no medications disclosed,none,none,,"Documented no allergies to COVID vaccine, vaccine products, or other medications. No allergies disclosed at screening. At time of event stated that about June 2020 had swollen tongue after bee sting which lasted about 1 hour but did not seek medical care at time.","['Dysphonia', 'Flushing', 'Salivary hypersecretion', 'Speech disorder']",1,MODERNA,IM 931599,,36.0,F,"Staff RN was observing the above mentioned person and noted she was having splotchy looking non raised reddish rash on arms and neck area. I also noted she had it on her upper neck & back area. She was given 25mg of benadryl PO. She denied shortness of breath, throat swelling, difficulty swallowing or itching at this time. She also denied any other symptoms. She was verbalizing well and denied any allergies prior to taking her benadryl or vaccine. (Our observation room had equipment and medical emergency box available . Our ED is available also if needed) She was observed for about 1 hour. She did not have any continuation of rash or new symptoms. Fact Sheet for COVID vaccine already given &V-Safe.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,UNK,,,,,,"['Rash', 'Rash erythematous', 'Rash macular']",UNK,MODERNA,IM 931600,,63.0,M,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Inappropriate schedule of product administration'],UNK,PFIZER\BIONTECH, 931601,GA,31.0,M,"Member given Covid-19 Vaccine at approximately 10:38- member placed in observation room for 30 min observation time- at approximately 11:00 member appeared to be in a daze, slow to speak when asked questions- member unable to completely verbalize what he wanted to say- Vital signs stable- member asked what his birthday was and responded with ""My body is fine"". Member was able to transfer from observation chair to wheelchair, but needed assistance. Member transferred to the ACC for further evaluation",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,traMADoL (ULTRAM) 50 mg Oral Tab 15 tablet 0/0 12/14/2020 6/15/2021 Sig - Route: Take 1 tablet by mouth every 6 hours as needed for pain - Oral Ibuprofen (MOTRIN) 800 mg Oral Tab 90 tablet 0/0 11/22/2020 Sig - Route: Take 1 tablet by mouth,as of 1/9/2021 ICD-10-CM Priority Class Noted - Resolved MIGRAINE (Chronic) G43.909 2/12/2019 - Present MILD PERSISTENT ASTHMA (Chronic) J45.30 7/22/2020 - Present,as of 1/9/2021 ICD-10-CM Priority Class Noted - Resolved MIGRAINE (Chronic) G43.909 2/12/2019 - Present MILD PERSISTENT ASTHMA (Chronic) J45.30 7/22/2020 - Present,Flu Vaccine caused similar effects,No Known Allergies,"['Feeling abnormal', 'Slow speech']",1,MODERNA,IM 931602,PA,31.0,F,"10:47a went into a room to wait for 15 minutes directly after the injection. Began to feel somewhat dizzy right afterwards. Continued back to my office. Informed my supervisor that I was feeling dizzy but informed him that I had a couple bites of oatmeal, and a few cups of coffee and was going to try and eat something and hydrate and I?m sure I would feel better. I went back to work for about an hour (I work at a desk). For about an hour I continued to feel dizzy and noticed I was cloudy and was staring off. After an hour I really became dizzy and walked to my supervisors office and informed him. It felt as though I was walking on the moon to get to his office. I also felt like I had a uti. I sat down in his office and informed him of what happened. As I was talking to him I began to pass out. I did not go out the whole way but he began speaking to me more. After feeling a little better I walked back over to my office. I felt waves of dizziness and being hot and cold. My husband came and picked me up around 1:30p from work. I felt better after getting in the car and going home. Once I was home I ate and had began to feel better. Around 6:00p I began to go through another wave and was experiencing body aches, hot and cold sweats, loss of appetite, tingling all over my body but mostly in my legs and feet. At that point I went in and laid down in bed for the rest of the night. Probably around 9:00p I began to feel better. I attempted to fall asleep around 11:00p but when I closed my eyes I felt like they were racing back and forth. So I got back up and watched something in tv until I fell asleep maybe about 30 minutes later. I woke up the next morning around 8:45a. I tossed and turned most of the night, however I felt better. It was like I had the flu for a few days and on the last day I felt better but was under the weather. At this point in the morning I was fatigued. I was able to perform some tasks around the house. I then laid back down in bed for a few hours because I was beginning to feel dizzy and was experiencing hot and cold sweats. After a few hours I got up from bed and performed a few more tasks around the house. Then was able to sit down on the couch and watch some tv. At this point I?m still expediting tingling in my body at times. Still a little dizzy but able to focus and hot and cold sweats.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PUB,"Protonics, d12, multivitamin, prenatal, valtrex, protonics, vitamin c",No,No,Flu Vaccine- 31 years old- experienced body aches and hot and cold sweats a few hours following the vaccine. I recovered in abou,Coedine,"['Decreased appetite', 'Dizziness', 'Eye disorder', 'Fatigue', 'Feeling abnormal', 'Feeling of body temperature change', 'Hyperhidrosis', 'Influenza like illness', 'Pain', 'Paraesthesia', 'Sleep disorder', 'Staring']",1,MODERNA,SYR 931603,,64.0,M,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Inappropriate schedule of product administration'],UNK,PFIZER\BIONTECH, 931604,TN,43.0,F,Started menstruation that afternoon. Off cycle... 1 week - 2 weeks early. Not typical for me... I'm very regular. Not on birth control but husband has vasectomy. Chance of pregnancy is extremely unlikely. Started with bad cramping in pelvis and aching legs. Cramps have lessened. Dark blood. Brownish in color.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,WRK,"Zoloft, wellbutrin, zertec, caffeine, vitamin c",No - sinus/ indoor allergies,No,,No,"['Dysmenorrhoea', 'Menstrual disorder', 'Pain in extremity']",UNK,PFIZER\BIONTECH,IM 931605,,46.0,F,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Inappropriate schedule of product administration'],UNK,PFIZER\BIONTECH, 931606,NJ,58.0,F,Approx 6 min after getting shot I felt a jab like a nerve tingle go up my left neck to the left side of my scalp where it felt odd (timgle) and i reported to Emt on site so i stayed an extra 15 and left. Approx 3hr later I felt left face cheek numbness that radiated to the left side of my scalp where i first felt the tingle. This sensation was not present the next day 1/9,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,Metformin levothyroxin lisinipril almodipine besylate multi vitimin vit d and calcium iron,none,hashimoto's thyroiditis high bp pre diabetes/diabetes,,sometimes when eating fish or shellfish I get hives,"['Hypoaesthesia', 'Paraesthesia']",1,MODERNA,SYR 931607,IL,71.0,F,"Pain swelling/hardness, redness, of injection site approximately 2 inches in diameter when first noticed >1 week after injection. Contacted primary care physicians and instructed to take ibuprofen and use topical hrdrocortisone. Size increased to 3 inches the following day and experienced some chillls. No fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,"Atenolol, esomeprazole, vitamin D, Zyrtec",,"GERD, osteoporosis, SVT,",,None,"['Chills', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 931608,NY,64.0,F,"Intense left arm pain awakening me from sleep, fever 101.4, unable to hold down food or water, slept for almost 24 hours, could not go into work on 1/8/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,None,None,None,,"Penicillin, gadolinium","['Hypersomnia', 'Impaired work ability', 'Pain in extremity', 'Pyrexia', 'Sleep disorder', 'Vomiting']",1,MODERNA,IM 931609,,60.0,M,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Expired product administered'],UNK,PFIZER\BIONTECH, 931610,AK,33.0,F,"Several minutes after getting the shot, my chest started to feel tight and I needed to use my rescue inhaler. I stayed at the Clinic until 30 minutes had been up. When I arrived home I needed to use my Albuterol Nebulizer Solution, and started to get slightly itchy. My chest didn't start to feel better until after 2am, and the next day I noticed my arm at the injection site was swollen and slightly red. It is still red to this day and it feels achy all the way to my wrist.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,"Daily Vitamin, Vitamin D, Advair, Ventolin Inhaler(albuterhol)",Cyst in armpit,"Asthma, Allergies, Arthritis",,"Poultry, Fish, Seafood, Treenuts(almonds), Environmental","['Chest discomfort', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Pruritus']",1,PFIZER\BIONTECH,IM 931611,WI,23.0,F,"Patient reported feeling like her tongue was tingling and felt larger than normal. She did not report having any difficulty breathing. 25mg of Benadryl was given orally. After 10 minutes she thought she was feeling a bit better, but then continued to say that she was having tingling and not ""feeling normal"". We decided to administer epinephrine instead of waiting for her to continue to get worse. I administered an epi-pen (0.3mg) about 30 minutes after she took the Benadryl and a nurse from the SNF called 911. Paramedics arrived and evaluated her. Her breathing sounded okay via the paramedic's stethoscope. Because she was still not reporting feeling ""back to normal"" and because she had epinephrine administered, she was transported via ambulance to the ER for continued monitoring.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,SEN,,,,,,"['Feeling abnormal', 'Paraesthesia', 'Paraesthesia oral', 'Swollen tongue']",1,MODERNA,SYR 931612,,46.0,F,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Inappropriate schedule of product administration'],UNK,PFIZER\BIONTECH, 931613,GA,76.0,F,"Pt c/o having 'weird feeling/not feeling good' and increase heart rate about 7-8 minutes after receiving vaccine. Pt denied any shortness of breath at the time, no swelling of face, BBS clear and equal with equal rise and fall of the chest wall, alert and oriented X 4, able to speak in complete sentences. Progressed to report 'lips feeling like they are swelling approximately 18 minutes after the vaccine was administered. 911 was activated. Epinephrine 0.3 mg IM via epi autoinjector was administered to left thigh. Pt still c/o feeling that her lips were swelling 8 minutes after first dose of Epinephrine; therefore, another dose of 0.3 mg Epinephrine IM via epi autoinjector was administered to left thigh. Diphenhydramine 25 mg IV was administered 2 minutes after second dose of Epinephrine. IV fluids administered as well, while awaiting arrive of EMS. EMS arrived on scene approximately 30 minutes after called. Blood glucose was 120 mg/dl approximately 25 minutes after vaccine administration. Pt report feeling better after the 2nd dose of Epinephrine and Diphendydramine and 500 ml of Normal saline IV. Pt was transported via EMS to the ER for further evaluation and treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PUB,Unknown,Unknown; no illness at time of vaccine administration,Unknown,,None reported by patient,"['Blood glucose increased', 'Feeling abnormal', 'Heart rate increased', 'Lip swelling']",1,MODERNA,IM 931614,CO,26.0,M,"Chills, body aches, head aches, and general energy depletion",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Asthenia', 'Chills', 'Headache', 'Pain']",2,PFIZER\BIONTECH, 931615,NY,36.0,F,"Immediate: Dizziness, numb face, itching throat and nasal passage, itching tongue (slightly swollen) with lead like feeling, bruising on chest. 3 Days Later: Itching throat and nasal passage, itching tongue with lead like feeling and chest pain. 4 Days Later: Itching throat and nasal passage, itching tongue with lead like feeling and off-on chest pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,Levothyroxine,,"Sjogren's Syndrome, Hashimoto's Disease, Lupus, Asthma",,Naproxen,"['Chest pain', 'Contusion', 'Dizziness', 'Hypoaesthesia', 'Immediate post-injection reaction', 'Nasal pruritus', 'Paraesthesia oral', 'Swollen tongue', 'Throat irritation', 'Tongue pruritus']",1,MODERNA,IM 931616,CA,57.0,M,"flu like symptoms , significant fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,"Cialis 10mg, bupropion 150 mg, aspirin 81mg, lisinopril, xyzal,",None,Pollen allergies,,None,"['Fatigue', 'Influenza like illness']",2,PFIZER\BIONTECH,IM 931617,PA,34.0,F,"Vaccinated at 610am. Mild myalgias, pain at injection site, and headache starting around around 430pm when I woke up for work. Severe myalgias, fatigue, worsening headache, pain at injection site and chills noticed around 9pm on 1/8/21 continued until I went to sleep. I slept from 1am 1/9/21 to 230pm 1/9/21. Currently 4pm and experiencing mild generalized myalgias, mild headache, left shoulder and injection site pain and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,Escitalopram 10mg QD; Tri-Lo-Marzia QD,N/A.,"GAD, depression, Panic disorder.",,betadine-mild rash,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Somnolence']",2,PFIZER\BIONTECH,IM 931618,ME,52.0,F,"Hard lump developed 10 days after vaccine, then day 12-13 red elevated rash developed size of orange. improved by day 15.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/03/2021,10.0,WRK,levothyroxine,no,no,,no,"['Mass', 'Rash erythematous', 'Swelling']",1,MODERNA,SYR 931619,FL,68.0,M,"1. Mild soreness/ache at injection site, starting about 3 hours after injection, lasting for about 24 hours 2. Moderate fatigue, starting 4 hours after injection, ended by 9pm same day 3. Mild constipation, lasting 2 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,Atorvastatin Lipitor,None,None,"SEASONAL FLU VACCINE - WELL TOLERATED, EXCEPT THAT I HAVE INJECTION SITE SORENESS AND FATIGUE.",None,"['Constipation', 'Fatigue', 'Injection site pain']",1,PFIZER\BIONTECH,IM 931620,GA,36.0,F,"At the time of injection no issues other than sore arm. Day 9 post injection developed significant swelling, redness, warmth, and rash like irritation in left arm. Over the past 5 days there has been some decrease in swelling but the redness has formed a circle and has flare ups of rash, warm, and irritation. I have been taking benadyl, zyrtec, and cortisone cream to try and relieve symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/05/2021,9.0,PUB,"Bystolic, Nexium, Advil, Benadryl",none,hypertension,,none,"['Erythema', 'Pain in extremity', 'Peripheral swelling', 'Rash', 'Skin irritation', 'Skin warm']",1,MODERNA,IM 931621,AZ,37.0,F,"Aches, Chills, Nausea, vomiting, fatiuge - 48 hours. chest tightness- 6 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,Albuterol Inhaler PRN for Asthma,NONE,Asthma,,NONE,"['Chest discomfort', 'Chills', 'Fatigue', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,IM 931622,IN,38.0,F,"Muscle aches, nausea, fatigue, injecton site pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/17/2020,1.0,OTH,Birth control,None,None,,None,"['Fatigue', 'Injection site pain', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,IM 931623,CA,69.0,F,Nausea Extreme tiredness Body Ache Chills Fever. 100f,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/09/2021,8.0,SEN,Lisinopril /Hcz Lipitor Synthroid,None,Asthma,,Nine known,"['Chills', 'Fatigue', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 931624,MO,32.0,F,"1352 - Pt reports upper lip swelling, unable to see on visual assessment, BP-141/92, 100% on RA, T - 98.1, HR - 91, RR - 16. Given 25 mg of oral benadryl per this RN per vaccination clinic standing order. 1403 - Pt reports feeling no change from initial report but does note ""some finger tingling"". 92% on RA, HR - 88. 1410 - Discussed taking a 2nd 25mg dose with patient. Will hold at this time, she states ""my hands normally feel puffy when this gets worse but they feel normal now"". Pt reports upper lip swelling feels ""puffy"" but unchanged from initial report. 1418 - Pt reports upper lip swelling increased, BP - 140/85, HR - 80, RR 16, 100% on RA, 25mg of oral benadryl given. 1423 - Pt reports upper lip ""puffiness"" with slight improvement, new c/o upper back itchiness, no rash or hives visualized on assessment 1428 - Pt reports improvement to feeling of ""puffiness"", back itchiness remains the same, and pt ""feels sleepy"" 1438 - Pt reports resolution of upper lip swelling and says ""It feels like when I came in"", slight back itchiness still present 1448 - Pt reassessed 30 min post 2nd dose of benadryl, pt reports complete resolution of all symptoms, BP - 135/79, T - 98.2, RR - 14, HR - 78, 100% on RA Discussed transportation with patient prior to providing 2nd dose of Benadryl, Pt home via private vehicle with mother (driver) and partner. Educated patient to call nurse on call number with any further concerns or if symptoms resume.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PVT,,,,,"Clindamycin, Keflex, Lexapro, Naproxen","['Lip swelling', 'Metamorphopsia', 'Paraesthesia', 'Peripheral swelling', 'Pruritus', 'Somnolence']",2,PFIZER\BIONTECH,IM 931625,,45.0,M,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Inappropriate schedule of product administration'],UNK,PFIZER\BIONTECH, 931626,GA,52.0,F,Left axillary pain for 3 days. Very sore left axilla. NO redness. no edema.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/19/2020,2.0,UNK,"Celexa, Metformin, Vit D, Omega 3 Fatty Acid, Flonase, Astelin, Crestor,",I had COVID diagnosis on 10/22/20. I had a TdaP booster vaccine 24 hours prior to my COVID vaccine,1. anxiety 2. Dyslipidemia 3. Pre-Diabetes 4. Overweight,,no,['Axillary pain'],1,PFIZER\BIONTECH,IM 931627,IN,41.0,M,"About 12 hours after admin; arm, shoulder, neck pain, progressed to generalized body aches, nausea, severe headaches, cough, mass weakness, diarrhea, joint pain. Symptoms started subsiding about 15 hours after onset. Minor cough still persist with minor shortness of breath.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,Vit D3,None,None,,None,"['Arthralgia', 'Asthenia', 'Cough', 'Diarrhoea', 'Dyspnoea', 'Headache', 'Nausea', 'Neck pain', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 931628,MD,24.0,F,"awoke at 2 am with nausea, chills, generalized pain. Immediately felt myself start to pass out or have a seizure- I am not sure which. Family member reports my eyes were open with absent stare however I lost consciousness, <60s. My right calf was in a severe muscle spasm as soon as I became conscious which leads me to believe I had some convulsions. Nausea chills and generalized pain persisted throughout the rest of the morning. Stopped around 10 am and turned into pounding headache and fatigue. Additionally my left arm is in moderate to severe pain (not like the typical soreness I get with the flu shot). I am in significant pain moving my arm, but also changing body positions while keeping my shoulder still and close to my body (bending over, scooting over in bed).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,SCH,"GI probiotic, hormonal birth control",,crohns disease (been in remission about 1.5 years),,Penicillin (skin reaction),"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Loss of consciousness', 'Muscle spasms', 'Nausea', 'Pain', 'Pain in extremity', 'Seizure', 'Staring']",1,MODERNA,IM 931629,MA,43.0,F,"Moderna COVID-19 Vaccine EUA 8 days after receiving my vaccine I experienced warmth, rednessness, mild itching and firmness at the injection site. At the largest, the area was approx 8 cm across. It lased for 4 days and seemed to improve with administration of steroid cream and taking claritin and benadryl. I had no other systemic effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,PVT,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 931630,LA,46.0,F,"Fever, chills, night sweats, swollen glands under arm, swollen injection site, body aches, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"Synthroid, Motrin",None,"Thyroid disorder, vitiligo, psoriasis",,Penicillin,"['Chills', 'Headache', 'Injection site swelling', 'Lymphadenopathy', 'Night sweats', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 931631,TN,78.0,F,"Diarrhea, Fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,UNK,None,None,None,,None,"['Diarrhoea', 'Fatigue']",UNK,MODERNA, 931632,NH,18.0,F,"Skin rash around neck, hives Shortness of breath Swelling Nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,SEN,Oral Contraceptive,,,,,"['Dyspnoea', 'Nausea', 'Rash', 'Swelling', 'Urticaria']",1,PFIZER\BIONTECH,SYR 931634,RI,29.0,F,"Pt entered observation @ 1530. @ 1540 pt stated her throat felt ""tingly"", when this asked her if she felt ok. @ 1541 pt stated she felt a small lump. This nurse assisted pt to bed in vaccination clinic. Stated the lump felt ""bigger"". This nurse administered Epi 0.3mg to R thigh @ 1544. Pt stated s/s were better @ 1548. Cold compress was also applied. This nurse assisted pt to ER. Pt @ ER @ 1605. When this nurse left pt, she was being assisted by ER for registration. Denied any s/s of chest pain or SOB.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,WRK,"Cymbalta, Trazodone, IUD",,"Asthma, Narcoplsy",,"Darvocet, Reglan","['Pharyngeal paraesthesia', 'Sensation of foreign body']",1,MODERNA,IM 931635,,52.0,M,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Inappropriate schedule of product administration'],UNK,PFIZER\BIONTECH, 931636,AZ,43.0,F,"Moderna COVID-19 Vaccine EUA. Severe headache, muscle aches, nausea, vomiting, fatigue, soreness at site of injection. Symptoms beginning ca. 12 hr after injection. Vomited 4x between 2:30 a.m. and 11 a.m. Symptoms somewhat improved by 2:30 p.m on 01/09/2021, 24 hr after injection: headache reduced, able to consume liquids, but still fatigued.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,None.,,Von Willebrand disease Type 1,,None.,"['Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 931637,KY,37.0,F,"Approximately 10 hours after receiving the vaccine, I had a sore arm. Then experienced aches in my hip and knee joints, hot sweats alternating with chills, I did not take my temperature. I woke up the next morning with a headache and skin sensitivity. I took ibuprofen alternating with Tylenol and started to feel better. I felt back to normal about 36 hours after receiving the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,WRK,Montelukast Junel Nasonex Multivitamin Zyrtec,None,Seasonal allergies,,Sulfa,"['Arthralgia', 'Chills', 'Headache', 'Pain in extremity', 'Sensitive skin', 'Sweating fever']",2,PFIZER\BIONTECH,IM 931638,NC,39.0,F,"numbness and tingling in left side of face (1/8), also in tongue and right hand (1/9)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,PVT,"adderall, protonix, singulair, yaz, krill oil, vitamin d, biotin, probiotic",none,"history of guillain-barre syndrome (2017), asthma, allergies, adhd",,"latex, neosporin, adhesives","['Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia', 'Paraesthesia oral', 'Tinea capitis']",2,PFIZER\BIONTECH,IM 931639,,40.0,M,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Expired product administered'],UNK,PFIZER\BIONTECH, 931640,KY,90.0,F,Nurse wanted this rxn reported. The patient had severe chills. The nurse said this is not normal for this patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,PHM,Pt is in nursing home. Unsure.,Pt is in nursing home. Not sure.,"morbid obese, Type 2 diabetic, HTN, Pt is in nursing home, not sure if complete list.",,"promethazine, sulfa",['Chills'],1,PFIZER\BIONTECH,IM 931641,,53.0,F,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Inappropriate schedule of product administration'],UNK,PFIZER\BIONTECH, 931643,MN,25.0,F,"Body aches began at 11pm night of receiving vaccine. Headache, chills and low grade fever (up to 100.1) developed following day. 48 hours after vaccine headache and body aches persist, chills and fever resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Venlafaxine Amitriptyline Propranolol Vitamin C Sumatriptan Magnesium Melatonin,Ear issue and vertigo. Diagnosis not yet determined,Migraines Unspecified tachycardia Obesity,,Cefpodoxime,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 931644,IN,51.0,F,"Fever, chills, profuse sweating, tremors, body aches, headache, teeth pain, eye pain, nausea, diarrhea, fatigue, coughing",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Synthroid, Carafate, Triamterene HCTZ, Sertraline, Claritin, multi vitamin, D3, Biotin, probiotic, garlic, ginger, b12, Linzess",I had Covid beginning 12/4/20 and it lasted for two weeks,"Rheumatoid arthritis, Meneires disease, hx of gastric bypass, hypothyroidism, GERD",,"Zyrtec, Flexaril, Topamax","['Chills', 'Cough', 'Diarrhoea', 'Eye pain', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pain', 'Pyrexia', 'Toothache', 'Tremor']",1,MODERNA,IM 931645,CA,32.0,F,"1. Injection site pain: started soon after injection continued to get worse until 1 day after injection then progressively got better 2. Fever: t-max 38.2 orally noted at 0430 1/6/21. Fevers associated with chills and rigors at times. 3. Extreme joint and body aches: started early morning 1/6/21 and progressively got worse until 1/7/21 then got better with subsiding around 1/8/21. Pain preventing/limiting normal movements such as walking, turning, and weight baring. 4. Extreme fatigue: sleeping for 18-20 hours a day with hard to stay awake 1/6/21-1/8/21. Resolved by 1/9/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,WRK,Pre-natal vitamin,No e,Asthma Migraines,,Penicillins Cephalosporins Some tape adhesives,"['Arthralgia', 'Chills', 'Fatigue', 'Injection site pain', 'Mobility decreased', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 931646,KY,22.0,F,"Soreness at injection site roughly 10 minutes after injection, soreness went away a few minutes afterwards. Injection was given in the morning, around 10am, around late afternoon, 4-5pm, area around injection site was very sore, as if there was a bad bruise there, but there was no visible marks. Shoulder was very sore to the point of hardly being able to lift arm to the side away from the body. Day after injection arm was still sore but the pain was less. 2 days after injection, arm was only slightly sore in the morning with no pain by mid afternoon.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,SEN,Zoloft,None,None,,None,"['Arthralgia', 'Injection site pain', 'Mobility decreased']",1,PFIZER\BIONTECH,IM 931647,AK,59.0,F,"After 30 minutes, patient complained of tingling on right side of tongue and feeling of fullness on right side of throat. Te=reated with 25mg of oral benadryl, symptoms improving but not resolved so 25mg PO repeated at hour later. Symptoms completely resolved approxiamtely 2 hours after onset of symptoms. Patient was under direct observation during this time. Patient discharged in stable condition. Patient provided additional oral benadryl to take home and use prn. Additional home epi pens provided with instructions on use if needed. Patient instructed to not be alone during next 24 hours. Sone would be staying with patient. On site health aide provider available during after hours and emergency response in village. Provider from team NP, contacted patient later evening and checked on patient status, reported to be doing well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,Atorvastatin 20mg daily Cabergoline 0.5mg weekly Ceterizine 10mg daily DOK 100mg BID Flonase 50mcg daily Lantus Solistar 34u qhs Lisinopril 10mg daily Metformin ER 500mg 4tab daily Omeprazole 20mg daily Ozempic 0.5mg weekly,UTI treated with Macrobid on 12/14/20.,DIabetes typeII Hypertension GERD Hyperlipidemia Prolactinoma Obesity Allergic rhinitis,,nuts cause anaphylaxis niacin causes flushing Patient-reported allergy to cholesterol med (unknown which one) causing anaphylaxis,"['Paraesthesia oral', 'Throat tightness']",1,MODERNA,IM 931648,MN,35.0,F,"On 1.8.21, woke up with a temp of 101.8 oral, chills, body aches, terrible headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Celexa Probiotic Omeprazole Birth control pill,None,None,,None,"['Body temperature increased', 'Chills', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 931649,,30.0,F,"Chills & fatigue, 24 hours after vaccination. Lasted about 16 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Sertraline, trazodone, hydroxyzine",None,,,None,"['Chills', 'Fatigue']",1,MODERNA,IM 931650,TX,42.0,M,Heart palpitations and shortness of breath starting around 11 this morning. Received vaccine yesterday at 4:30.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,UNK,Vyvanse (haven?t taken since Wednesday 1/6/2021),,"Asthma, adhd",,"Animals, dust, grasses and trees","['Dyspnoea', 'Palpitations']",1,MODERNA,SYR 931652,,53.0,M,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Inappropriate schedule of product administration'],UNK,PFIZER\BIONTECH, 931653,IL,30.0,F,"Dizziness, increased heart rate, feeling like fainting, and headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,None,None,None,,None,"['Dizziness', 'Headache', 'Heart rate increased', 'Syncope']",1,PFIZER\BIONTECH,SYR 931654,IN,67.0,F,"nausea, severe body aches, headache, felt very cold, weak, sore arm all subsided by 1/9/21 except sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,"maxide , losartin, calcium with vit.D, singular, aspirin",sinus headache (chronic),"HTN, asthma (allergy related), arthritis, over weight","flu shots, resistance goes down and in past got mild flu like symptoms but not this last year","PCN, codeine, Erythromycin, biaxin","['Asthenia', 'Feeling cold', 'Headache', 'Nausea', 'Pain', 'Pain in extremity']",1,MODERNA,IM 931655,CA,32.0,F,Approx 5-6 hours after vaccination she felt an itchy throat and broke out in hives on chest and legs. She took benadryl and this resolved. Approx 24 hours later she started with sore throat and cough and mild SOB.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,Mild intermittent asthma mitral valve prolapse,,Motrin,"['Cough', 'Dyspnoea', 'Oropharyngeal pain', 'SARS-CoV-2 test', 'Throat irritation', 'Urticaria']",UNK,PFIZER\BIONTECH,IM 931656,NY,54.0,M,"I am a front line physician. I had moderate Covid in March 2020. After my vaccination at 2:15pm on 1/6/2021 I had very slight chills at 11:30 pm as I went to bed. I awoke at 5:30am 1/7/2021 with severe chills and very slight fever of 98.8 (oral). I took 800mg Advil then. I remained in bed with chills until 4pm. I had a fever of 100.0 at 11:45am. Took 800mg Advil. Chills subsided to mild around 4pm. Was able to walk around house. Ate dinner. No GI symptoms. 11:30pm had fever 100.0 and moderate to sever chills. Took 800 mg Advil. Felt better and went to sleep at around 1am. Woke up 6am 1/8/2021 and was able to go to work. When I got to work I was able to sign up for this reporting service but could nit document my first day of symptoms. I took that opportunity now. I believe it is important that I had these reactions after having the covid illness 3/2020. I had small amount remaining antibodies at time of Vaccination, which surely contributed to my response.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,UNK,"Lisinopril, carvedilol, atorvastatin, vitamin D, aspirin 81mg, coQ10.",None,"Hypertension, hyperlipidemia.",Fever and chills after flu vaccine for many years.,None,"['Chills', 'Pyrexia']",UNK,MODERNA,IM 931657,,23.0,F,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Inappropriate schedule of product administration'],UNK,PFIZER\BIONTECH, 931658,PA,52.0,F,"after receiving vaccine patient immediately felt warm, dizzy and started dry heaving. we dosed Zofran 4mg, gave one dose epi-pen, and 50mg Benadryl. patient still complained of chest pain and was dry heaving. she was then transported by ems to the hospital at 4pm.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/09/2021,01/09/2021,0.0,SEN,gummy multivitamin,none,none,,"Demerol, PCN, onions","['Chest pain', 'Dizziness', 'Feeling hot', 'Immediate post-injection reaction', 'Retching']",1,PFIZER\BIONTECH,IM 931659,IL,41.0,F,"Tingling in injection arm, fingers; tingling in face; tongue swelling 30 minutes- 1 hour after vaccine. Visited immediate care; received IV of Benadryl, Pepcid & Steroid.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Levothyroxine Vitamin D Elderberry Mirena IUD,None,Hypothyroidism,,None,"['Paraesthesia', 'Swollen tongue']",2,PFIZER\BIONTECH, 931660,,33.0,M,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Inappropriate schedule of product administration'],UNK,PFIZER\BIONTECH, 931661,OR,38.0,F,"Initial headache, body aches, shaky hands and body, swelling of fingers(pinky, ring and middle fingers of right hand), pain in finger joints(pinky, ring and middle fingers)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,"Prazosin, Vyvanse, Tylenol(prn), feverfew, butterbur, coenzyme Q10, iron, vitamin D, B Complex, vitamin C, metformin, ubrelvy (prn), ajovy, Metoclopramide(prn), Ondansetron (prn), albuteral (prn), nexplanon implant, furosemide (prn), potass","Allergies, history of anaphylaxis, history of migraines from tbi, history of reactions with medications.","Migraine, allergies",,"Latex hypersensitivity (includes food allergies to ginger, kiwi, tumeric, cayenne), Nutrasweet (phenylalanine), Preservatives in ""caines"" not a ""caine"" allergy. Seasonal allergies. History of side effects to tripans, topiramate, Reyvow, effexor, fluoxetine.","['Arthralgia', 'Headache', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Tremor']",1,MODERNA,SYR 931662,NC,49.0,F,Received vaccine 12/19/2020 at hospital around lunch time. Severe abd pain started 10 hours after vaccine administration with vomiting. I went to emergency room next morning Emergency appendectomy 12/20/2020. Had bleeding after surgery. Second surgery 12/21/2020,Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,"Zyrtec, vitamin c, singular,, lisinopril, xolair","Asthma, hypertension","Asthma, hypertension",,"Lovenox, latex, pollen, mold, cat dander","['Abdominal pain', 'Appendicectomy', 'Computerised tomogram', 'Full blood count', 'Metabolic function test', 'Post procedural haemorrhage', 'Surgical procedure repeated', 'Vomiting']",1,PFIZER\BIONTECH,IM 931663,KS,40.0,F,Swollen and painful left infraclavicular lymph node 2 days after 2nd COVID vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/09/2021,2.0,PVT,Spironolactone Vitamin D3 Zinc,No,None,,Latex,"['Lymph node pain', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 931664,,36.0,F,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Inappropriate schedule of product administration'],UNK,PFIZER\BIONTECH, 931665,KY,43.0,F,"Severe chills, headache, stiff neck, nausea, diarrhea, weakness. Onset of chills approx. 8 hours post immunization. Severe shaking chills occurred with decreasing frequency over next 48 hours. Headache more intense for 48 hours, but persists still today (1/9/21). Nausea for 48 hours. Diarrhea lasted 4 days with decreasing frequency. Stiff and painful neck and base of skull has steadily decreased but is still present today (1/9/21).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,"Norvasc, Bisoprolol, Nexium, Zoloft, HCTZ, Losartan, Vitamin D",throat infection treated with Amoxicillin,"HTN, Obesity, Depression, Anxiety, GERD, Thrombocytopenia, Vitamin D deficiency, Vitamin B-12 deficiency, Alpha Gal",,"Alpha Gal, red meat allergy","['Asthenia', 'Chills', 'Diarrhoea', 'Headache', 'Laboratory test', 'Musculoskeletal stiffness', 'Nausea', 'Neck pain']",1,PFIZER\BIONTECH,IM 931666,IL,48.0,F,"Elevated Heart Rate, Elevated Blood pressure (160/100), difficulty swallowing, blotching to chest and neck",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PVT,,,,,,"['Blood pressure increased', 'Dysphagia', 'Heart rate increased', 'Rash macular']",UNK,PFIZER\BIONTECH,IM 931667,IN,23.0,F,Two painful lumps near collar bone on injection side,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,UNK,Birth control,,,,None,"['Mass', 'Pain']",UNK,MODERNA,SYR 931668,PA,35.0,F,"Hours after injection: 100.2 fever, chills, lethargy, muscle aches, couldn't lift left arm, muscle pain at injection site Next day: pain in arm, struggle to lift arm above shoulder, rash on chest, neck, and forehead. All other symptoms abated.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,OTH,"Cymbalta 30mg, gabatril 6mg, multivitamin, probiotic, fish oil",,"Sleep disorder, anxiety disorder",,"Sudafed, levaquin/cipro, akleve, clindamiacin, mold, dust, pollen","['Chills', 'Injected limb mobility decreased', 'Injection site pain', 'Lethargy', 'Myalgia', 'Pain in extremity', 'Pyrexia', 'Rash']",1,MODERNA,IM 931669,IN,39.0,F,"Extreme fatigue, slight headache...otherwise I feel fine, but the fatigue has made it hard to do things.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"Levothyroxine, Blisovi 24 FE, biotin, collagen, multivitamin, omega 3, loratadine",None,None,,"Cats, ragweed, mold","['Fatigue', 'Headache']",1,PFIZER\BIONTECH, 931670,,39.0,M,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Inappropriate schedule of product administration'],UNK,PFIZER\BIONTECH, 931671,,27.0,F,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Inappropriate schedule of product administration'],UNK,PFIZER\BIONTECH, 931672,IL,48.0,F,Elevated Heart rate and blood pressure. Blotching to chest and neck. difficulty swallowing.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PVT,,,,,,"['Blood pressure increased', 'Heart rate increased', 'Rash']",2,PFIZER\BIONTECH,IM 931673,,30.0,M,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Inappropriate schedule of product administration'],UNK,PFIZER\BIONTECH, 931674,PA,44.0,F,Patient called and stated that left side of her face turned red and had a small rash. She has some sort of difficulty breathing and felt her tongue somewhat swell up. I informed her to take benadryl 50mg right away and seek medical emergency at urgent care or ER.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PHM,unknown,unknown,none,,unknown,"['Dyspnoea', 'Erythema', 'Rash', 'Swollen tongue']",1,MODERNA,IM 931675,IN,32.0,F,"As soon as it was administered, I felt my heart start racing and felt a tingling sensation through my entire body especially in my hands and feet. I let the nurse know under observation and she took my vitals and my BP was high for me as well 146/85. I waited for an hour and then had my husband pick me up. The tingling continued for a week and a half and made it impossible to sleep. It?s slowly gotten better, but I still feel almost a palpitation/flutter feeling.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/26/2020,0.0,PVT,"Lexapro, oral birth control",None,None,,None,"['Hypertension', 'Palpitations', 'Paraesthesia', 'Sleep disorder']",1,PFIZER\BIONTECH,IM 931676,MA,62.0,F,"High fever, fatigued, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,1 zyrtec,Covid 12/28 felt like head cold temp 99.4 1 day. No other symptoms,None,,None,"['Chills', 'Fatigue', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931677,,27.0,F,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Expired product administered'],UNK,PFIZER\BIONTECH, 931678,FL,,F,"PATIENT RECEIVED FIRST COVID VACCINE AND STARTED FEELING DIZZY AT 15 MINUTE WINDOW, EMS WAS NOTIFIED AND HELPED CLIENT TO AMBULANCE. PATIENT WALKED TO AMBULANCE AND BACK TO HER VEHICLE WITHOUT ASSISTANCE. EMS FOUND PATIENT TO BE HAVING PANIC ATTACK, VITAL SIGNS STABLE, SLIGHT HEADACHE AFTER DIZZZINESS RESOLVED. PATIENT HAS HX OF R/A AND CARDIAC HISTORY AS WELL AS ANXIETY.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,06/01/1952,01/09/2021,25059.0,PUB,None noted,Rheumatoid Arthritis,R/A,,None,"['Dizziness', 'Headache', 'Panic attack']",1,MODERNA,SYR 931679,CT,63.0,F,"Localized 4"" induration with tenderness.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/08/2021,8.0,PVT,,Melanoma,,,,"['Induration', 'Tenderness']",UNK,MODERNA, 931680,NY,51.0,F,"lip swelling, facial hives/erythema, burning",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,,,,,"Augmentin, Shellfish, Latex, passionfruit, carrot","['Burning sensation', 'Erythema', 'Lip swelling', 'Urticaria']",1,PFIZER\BIONTECH,IM 931681,,68.0,F,"The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,UNK,,,,,,['Inappropriate schedule of product administration'],UNK,PFIZER\BIONTECH, 931682,TX,32.0,F,person complained of tenderness and tingling down left arm. They are 25 weeks pregnant.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PUB,"prenatal vitamins, claritin prn",none,none,,none,"['Exposure during pregnancy', 'Pain of skin', 'Paraesthesia']",1,MODERNA,IM 931683,TX,29.0,F,"Infra clavicular lymphadenopathy noted on 12/21/20. Followed by supraclavicular lymphadenopathy noted on 12/30/2020. Since I have extensive family history of brear cancer and lymphoma I got lab work and a CT scan with contrast of my chest and neck. Labwork (cbc, cmp, ana, crp) was normal. Peripheral smear showed increased in Roloux phenomenon. CT showed unilateral generalized lymphadenopathy on axillary, infraclavicular, supraclavicular and cervical region. With some noted measuring > 1cm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/21/2020,3.0,SCH,Birth control,None,None,,None,"['Computerised tomogram thorax', 'Laboratory test normal', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 931684,AL,31.0,M,"I got a muscle ache on the injection site 4-5 hours after the jabbing, and a febrile (97.4), tiredness and headache the next day of it. I took a NSAIDS tablet 3-4 hours after showing up febrile. I almost recovered with a little bit of a headache 2 days later of the injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,SCH,No,No,No,,No,"['Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 931685,MD,62.0,M,"Modern COVID-19 vaccine Fever to 102.4 with shaking chills, joint aches, extreme fatigue for 36 hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Aspirin 81mg Multivitamins,COVID-19 infection 7 weeks prior,Donated a kidney as a live donor in 2019,,None,"['Arthralgia', 'Chills', 'Fatigue', 'Pyrexia']",UNK,MODERNA,IM 931686,TX,62.0,F,lightheadedness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,"norvase, lipitor, gabapentin, baby aspirin",none,"hypertension, triple bypass 2018, Type II diabetes",,morphine,['Dizziness'],1,MODERNA,IM 931687,IL,24.0,F,"12 hours later 10:00pm experienced chills, body aches, fever headache. 1/8 at 7:00am woke up itchy covered in hives head to toe. Hives resolved after topical and oral antihistamine taken.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Birth control, cephlaxin",UTI,N/a,,"Tree nut, mango, pineapple, seasonal allergies","['Chills', 'Headache', 'Pain', 'Pruritus', 'Pyrexia', 'Urticaria']",2,PFIZER\BIONTECH,SYR 931688,GA,70.0,F,"On 9th day following vaccination, I developed swelling, redness, itching and induration at the injection site. Also experiencing headache and spike in blood pressure, not sure whether related or not.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/09/2021,9.0,PVT,"Vyvanse, Hydrochlorothiazide, levothyroxine, metoprolol, atorvastatin, montelukast, omeprazole and baby aspirin.",,"Hypertension, total thyroidectomy, ADD, elevated triglycerides, GERD, seasonal allergies to pollens.",,Intolerance to codeine,"['Blood pressure increased', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 931689,CO,39.0,F,"On 1/8/2021 I woke up with severe chest pain under my breast bone, radiating to my upper back. It came in waves a severe sharp pain and then was dull. I?ve never had heartburn or indigestion so I went to Urgent care around 10am on 1/8/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,Tylenol for pain,I was sick the week before but was fully recovered on 1/7. I had a negative COVID test before and had a negative COVID test yesterday on 1/8,Hashimoto?s Thyroiditis Chronic Autoimmune Urticaria Depression Anxiety,,Allergic to codeine,"['Back pain', 'Chest X-ray normal', 'Chest pain', 'Dyspepsia', 'Electrocardiogram normal', 'Pain', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,SYR 931690,IN,23.0,F,"Headache, fatigue, muscle aches, site of injection soreness, nausea, swollen lymph node on neck",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,UNK,N/a,N/a,N/a,,"Food: canola oil, cherries, red 40","['Fatigue', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Myalgia', 'Nausea']",1,MODERNA,SYR 931691,AK,21.0,F,"Severe body aches and fatigue, chills, tachycardia, chest pain and tightness, headache, stomachache, gastrointestinal issues, nausea, inability to focus, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,WRK,"Zoloft, prazosin, buspar, bupropion, gamunex IV, pantoprazole",Broken toe,"GERD, CVID, asthma, migraines, psychiatric,",,Cat dog clindamycin arrythromycin sulfa cephalosporins blue dye 106,"['Abdominal discomfort', 'Abdominal pain upper', 'Chest discomfort', 'Chest pain', 'Chills', 'Disturbance in attention', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Tachycardia']",1,PFIZER\BIONTECH,SYR 931692,TX,34.0,F,"After receiving the vaccine on 12/30 the only side effect at that time was arm soreness at the injection site. A day later some chills and fatigue but no other side effects after. I noticed starting on 1/4 pain started on injection arm from shoulder down lower to extremities on left arm. Pain very excruciating but comes and goes. Joint pain and muscular pain throughout entire arm and even in right arm. After couple days of this, contacted family physician regarding this. Was seen by physician on 1/6. Discuss concerned and he ordered X-rays on both arms and ultrasound droplet on entire left arm (injection site- from shoulder in down). MD also I formed me to take Advil/Aleve twice a day as needed for pain/soreness along with heat/cool compressions as needed as well as shoulder exercises. Today is 1/9 and pain isn?t as bad. Can still feel discomfort here and there but not as excruciating. Numbness from time to time also. Is this normal after receiving the Moderna vaccine? Is it normal to experience this a week after receiving the vaccine?",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PVT,"Omprazole 40mg, OTC- Vitamin D 6,000, multi-vitamin, stool softener",None,None,,NKDA,"['Arthralgia', 'Chills', 'Discomfort', 'Exostosis', 'Fatigue', 'Hypoaesthesia', 'Injection site pain', 'Myalgia', 'Pain in extremity', 'Ultrasound scan normal']",1,MODERNA, 931693,TX,67.0,F,"Severe rash, swelling and pain at injection site for over 10 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,"alprazolam, valsartan, carvedilol, omeprazole, welbutrin, synthroid, seraquil,",,"high blood pressure, hypothyroidism, acid reflux",,penicillin,"['Injection site pain', 'Injection site rash', 'Injection site swelling']",1,MODERNA,IM 931694,RI,58.0,F,"One week later (on a Wednesday morning after receiving the vaccine the previous Wednesday afternoon) I had the onset of a headache, body aches, chills and extreme fatigue making it impossible to work. Slept most of the day. Next couple days with less severe symptoms and mostly resolved this morning (Saturday) aside from some fatigue. ALSO the site of the injection became red, tender, warm, swollen and slightly itchy with the onset of these symptoms after a milder injection reaction had resolved for several days. This makes me question if this is a late reaction to the vaccine and hence reportable as I have not read about this possibility",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PUB,"Rx: estradiol, lisinopril, Cymbalta, Concerta OTC: biotin, fish oil capsules (650 EPA/450DHA)",None,Post-menopausal HTN History of depression ADHD,,Monistat vaginal cream,"['Chills', 'Fatigue', 'Headache', 'Hypersomnia', 'Impaired work ability', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pain', 'SARS-CoV-2 test negative']",1,MODERNA,IM 931695,KS,55.0,M,"Headache, Nausea, Night sweats, Body aches, Tinnitus",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,"Multiple vitamin 1 po QD, Docusate 100 mg QD, Magnesium 400 mg po QD, Potassium 20 meq po QD, Vitamin D 1,000 ut daily, Diavan/HTCZ 80/12.5 daily, effexor 37.5mg BID, Zocor20mg daily, Plavix 75mg daily, Tadalafil 5mg daily, Metformin 500 mg",none,"HTN, DM, GERD, Diverticulitis, Rheumatic fever age 7",,Morphine,"['Headache', 'Nausea', 'Night sweats', 'Pain', 'Tinnitus']",1,MODERNA,IM 931696,GA,34.0,F,"Moderna COVID-19 Vaccine After receiving Moderna Vaccine Tuesday afternoon (01/05/2021), Patient began to have psychiatric symptoms (delusions/hallucinations) Wednesday morning (01/06/2021) and was taken to Hospital ED later Wednesday for treatment and stayed overnight for observation. Patient recovered and went home Thursday (01/07/2021).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,None,None,None,,None,"['Blood test', 'Computerised tomogram head', 'Delusion', 'Hallucination', 'Psychiatric symptom']",1,MODERNA,IM 931697,NJ,44.0,F,"1st Dose Vaccine - I had localized itchy rash in my chest area 2nd Dose Vaccine - Right Cheek swelling, chills and dry mouth",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,NONE,none,none,,Shellfish,"['Chills', 'Dry mouth', 'Rash', 'Rash pruritic', 'Swelling face']",2,PFIZER\BIONTECH,IM 931698,TX,44.0,F,tingling in throat,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PUB,"xigduo, basaglar, HCTZ",none,"Type II diabetes, hypertension, psoriatic arthritis",,sulfa drugs,['Pharyngeal paraesthesia'],1,MODERNA,IM 931699,OH,42.0,F,"Bruise at injection site and bilateral facial swelling, noticed morning after the shot, swelling still persisting. I am taking benedryl every 4 hours to have swelling subside.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PUB,"Multivitamin, vitamin d3, elderberry chewable",None,None,,None,"['Injection site bruising', 'Swelling face']",1,MODERNA,IM 931700,AZ,29.0,M,"At 12:05am ( about 12 hours after vaccination) I developed severe (worst ever) chills and rigors. Temp was 101.7. I also had moderate nausea for which I took ondansetron. After taking 1000mg Tylenol my temp dropped to 98.4 but then peaked to 100.8 after 6 hours and taking 1000mg Tylenol followed by another fever 6 hours later and a fever of 100.9. I continue to be febrile after 3g Tylenol. I also continue to have dizziness, joint pain, myalgias, and headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,WRK,Flonase,None,Seasonal allergies,,None,"['Arthralgia', 'Chills', 'Dizziness', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931701,CO,79.0,F,"Swollen red and sore, itchy right arm, five inches spread, Cold symptoms .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,Thyroid meds. Vitamin D,None,Sleep apnea,,Codeine,"['Erythema', 'Nasopharyngitis', 'Pain in extremity', 'Peripheral swelling', 'Pruritus']",1,MODERNA,SYR 931702,VA,56.0,M,"Chills, body aches, soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,None,None,None,,None,"['Chills', 'Pain']",1,MODERNA,SYR 931703,CA,41.0,M,"Nurse working in Emergency Dept, developed first COVID sxm (mild cough) on 03 Jan 2021. On 05 Jan 2021, he received dose #2 of COVID vaccine (Pfizer lot EL1284). On 06 Jan 2021, sxms progressed to include fever, congestion, impaired taste and smell. On 06 Jan 2021, NP swab for PCR was performed and confirmed positive... patient being managed as outpatient.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/15/2020,01/03/2021,19.0,MIL,None reported,None reported,None reported,,None reported,"['Cough', 'Parosmia', 'Pyrexia', 'Respiratory tract congestion', 'SARS-CoV-2 test positive', 'Taste disorder', 'Viral test']",1,PFIZER\BIONTECH,IM 931704,MN,29.0,F,patient developed large rash on chest. Nausea and vomiting. Also had tightness and scratchiness in throat but did not progress,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,SEN,currently on Humira took injection about 2 days agao,none,rheumatoid arthritis taking,,allergy to peacans,"['Nausea', 'Oropharyngeal discomfort', 'Rash', 'Throat tightness', 'Vomiting']",1,MODERNA,IM 931705,TN,59.0,M,Nausea and vomitting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Ultram,hctz",None,Htn,,Nono,"['Nausea', 'Vomiting']",1,MODERNA,IM 931706,VA,25.0,M,"Injection site pain starting evening of 1/8/20. Mild swelling and severe pain at injection site morning of 1/9/20. Moderate progressing to severe headache, and intermittent chills all day; no fever. Reduced appetite. Mild muscle pain/stiffness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,Omeprazol magnesium,,,,,"['Chills', 'Decreased appetite', 'Headache', 'Injection site pain', 'Injection site swelling', 'Musculoskeletal stiffness', 'Myalgia']",1,MODERNA,IM 931707,TX,55.0,M,Patient stated he got severe diarhea 2 hrs after getting the vaccine. No immediate medical treatment was provided after observation of 15 minutes. Fact sheet and V-/Safe information was given to him prior to getting the vaccine. Doing well after couple days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,,,,,,['Diarrhoea'],UNK,MODERNA,IM 931708,TX,46.0,F,rash to face around cheeks and neck. Person has had similar reaction before,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PUB,protonix (did not take that day),none,none,similar type of reaction from a vaccination,"codeine, penicillin, azithromycin, budesonide",['Rash'],1,MODERNA,IM 931709,FL,57.0,M,Started running a fever 99.3-100.3 two days after vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,PVT,None,None,None,,None,"['COVID-19', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,MODERNA,IM 931710,TX,46.0,F,"Headache, left arm numbness, mild left arm pain Injection site, moderate Myalgia, severe migrating joint pain, chills leading to rigors. No fever. Incapacitating.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,UNK,"Vitamin D, Allegra, biotin, Aswaganda",None,None,,None,"['Arthralgia', 'Chills', 'Headache', 'Hypoaesthesia', 'Injection site pain', 'Myalgia']",2,PFIZER\BIONTECH,IM 931711,CO,42.0,F,"2nd dose reaction included extreme joint pain to where standing is painful in my feet, 103.4F temp with while alternating Tylenol/Advil q4h, large swollen lump in armpit and below clavicle which are extremely painful (on side of body where vaccine was administered). Stiff neck and jaw, severe headache, mild dizziness (was much worse after the 1st dose), nausea, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Lamotrigine 100mg, Ambien as needed, Doxycycline 50mg, daily women?s vitamin.",None,None besides gluten intolerance,1st Pfizer Covid vaccine as well,"Bee stings, gluten, most pain killers","['Arthralgia', 'Axillary mass', 'Axillary pain', 'Body temperature increased', 'Dizziness', 'Dysstasia', 'Fatigue', 'Headache', 'Joint stiffness', 'Lymphadenopathy', 'Musculoskeletal stiffness', 'Nausea', 'Pain in extremity']",2,PFIZER\BIONTECH,SYR 931712,CT,70.0,F,"after 1 day and lasting over 1 week, itching and oval shaped rash at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/02/2021,2.0,UNK,"Mercaptopurine, mesalamine, red yeast rice, vitamin, levothroxine",none,ulcerative colitis,,penicillin,"['Injection site pruritus', 'Injection site rash']",UNK,MODERNA, 931713,MA,45.0,M,"COVID-19 Vaccine Approx 4 hrs after vaccine felt a period of brief lightheadedness. Approx 7 hrs after vaccine had severe diarrhea that lasted 48 hrs in addition to flu type symptoms (fever 100.5, headache, chills) Left Arm pain radiating to elbow, unable to raise arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Advair Flonase,none,Asthma,,Amoxicillin,"['Chills', 'Diarrhoea', 'Dizziness', 'Headache', 'Influenza like illness', 'Injected limb mobility decreased', 'Pain', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 931714,NH,34.0,F,Headache severe x2 days Brain fog x 2 days Night sweats night 1 Weak/tired x2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Zyrtec, fish oil, prenatal vitamins, probiotics, magnesium",Chronic headaches,Interstitial cystitis Chronic idiopathic urticaria Infertility Hypermobility spectrum disorder Depression Anxiety,,Chlorhexidine Augmentin Macrobid Pineapple,"['Asthenia', 'Fatigue', 'Feeling abnormal', 'Headache', 'Night sweats']",1,MODERNA,IM 931716,NC,59.0,F,"About 6 hours after my second injection I started with a headache,bodyaches,low grade fever,chills. They lasted about 48 hours. Still have pain in my armpit on left side.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,None,None,Htn,,"Celebrex, Norvasc","['Axillary pain', 'Chills', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931718,GA,27.0,F,"I received my vaccine in my right arm around 3:20 pm on 1/5/21. My right arm started getting sore later that evening. The following day, 1/6/21, my arm was very sore and the injection site was tender to touch. I felt feverish and had chills. I also had a headache and felt very fatigued. I took some Advil that morning. I evaluated my arm in the evening and noticed a large red rash streaking down my right arm from the injection site. It measured approximately 3.5 in X 1.5 in. The rash was red, raised, painful, and firmer than my surrounding skin. I took 500 mg of Tylenol before bed. The next morning, 1/7/21, the rash had grown larger. The border of the rash was marked and I took an antihistamine around 7:00 am. At 1:00 pm the rash had grown larger, now measuring approximately 4.25 in X 2.25 in. My lymph nodes in my right armpit were also beginning to get sore. I visited the nurse practitioner at my hospital?s employee health clinic around 1:40 pm and we agreed to monitor my signs and symptoms at that time. The following morning, 1/8/21, the rash was bigger, but my skin was softer and more of a pink color than red. My arm did not hurt as much, though my right armpit was slightly more sore. Today, 1/9/21, my symptoms are much better. I have only slight soreness in my right arm and armpit. My rash has nearly resolved, though it is slightly itchy where the rash was.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Birth control,No illnesses,History of endometriosis,,No known allergies,"['Axillary pain', 'Chills', 'Fatigue', 'Headache', 'Injection site induration', 'Injection site pain', 'Injection site rash', 'Injection site streaking', 'Lymph node pain', 'Pain in extremity', 'Pruritus', 'Pyrexia', 'Rash', 'Rash erythematous', 'Rash papular', 'Skin discolouration']",1,MODERNA,IM 931720,NY,72.0,F,"Vomiting, Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Omeprazole, Misoprozole, Sertraline, Divalproex, Naproxen, Vitamin B-12, Vitamin D-3, Sulfasalizine, Irbesartan, Myrbetriq, Methotrexate, Leucovorin",None,"Bipolar, Sleep apnea, psoriatric arthritis, Barrett's esophagus, IBS",,"Lithium, Doxycycline","['Chills', 'Vomiting']",1,PFIZER\BIONTECH,IM 931721,CA,44.0,F,"Nurse Practitioner in Emergency Dept. Exposed to household member with possible sxms, but no confirmed dx. Developed personal sxms of ST and congestion on 02 Jan 2021. NP swab PCR performed 02 Jan 2021 was positive for COVID-19. Being followed as outpatient.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/15/2020,01/02/2021,18.0,MIL,None reported,None reported,None reported,,None reported,"['COVID-19', 'Electrocardiogram ST segment', 'Exposure to SARS-CoV-2', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 931722,CA,25.0,F,"Dark bruise looking, hyperpigmentation around injection site that was 4 inches wide and 2 inches long that appeared 11 days after first dose",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/07/2021,10.0,PVT,"Spironolactone, multivitamins, fish oil, B complex, probiotics, vitamin D3",None,None,,None,"['Injection site bruising', 'Injection site discolouration']",1,MODERNA,IM 931723,MO,55.0,F,"Severe muscle aches, headache, 100.3 temp, chills, tirid",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"Bariatric Vitamin, Biotin 5000mcg, Citracal Calcium +D3 Cetirizine 10 mg Amlodipine 5mg, Losartan Potassim 100mg, Omeprazole DR 20 mg, Tylenol 650 mg",None,High Blood pressure,,None,"['Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH,IM 931724,VA,65.0,F,"Approximately 55 mins after vaccine was given, my lips and the end of my nose started to tingle. The feeling intensified over 15 mins until it felt like a Novocain shot from the dentist when it starts to wear off. I took a Cetirizine 10 mg tab and the tingling completely resolved within an hour. No swelling of my mouth/ tongue or difficulty swallowing .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Ibuprofen-400 mg, Lisinopril-20 mg, Tricor-145 mg, ASA- 81 mg, Nexium-20 mg, Ca- 1000 mg, Vit D2- 50 mcg, Zinc- 23mg, magnesium-440 mg, Vit D3- 600 IU, Vit C- 1000 mg, Vit A- 600 mcg, Vit E- 13.5 mg, Selenium- 15 mcg, manganese-3mg, Sodium-",none,"Hypertension, high cholesterol, overweight",,Bactrim- generalized hives,"['Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 931725,MA,20.0,F,"Pt is a female on birth control (Nexplanon, left arm) and has not had her menstrual cycle since 9/2019. After receiving the COVID vaccine, pt experienced severe cramps and began her menstrual cycle with heavy flow. This is a manageable adverse reaction, but important to consider when administering COVID vaccines to female pts and how they might interfere with fertility, menstruation, and hormones.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/08/2021,2.0,PVT,"Escitalopram 10 mg, Methylphenidate XR 10mg",,,,,"['Menstrual disorder', 'Muscle spasms']",1,PFIZER\BIONTECH,IM 931726,CA,26.0,F,Abdominal pain. Can barely stand up.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PUB,Nortriptyline,No,Hyperthyroidism,,No,"['Abdominal pain', 'Dysstasia']",1,MODERNA,ID 931727,NM,44.0,F,"Headache, lump in right armpit, pain in right armpit unable to extend without sensation of pulling in armpit. Rash on upper chest itchiness of upper coast and left lower leg",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,,,Obesity Asthma DM,,Latex,"['Axillary mass', 'Axillary pain', 'Headache', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 931728,,32.0,F,"Large, hardened nodule at injection site approximately 2 inches in diameter, swelling, redness, itching",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/09/2021,7.0,PHM,spironolactone mirena iud,,migraines,,NKA,"['Injection site erythema', 'Injection site induration', 'Injection site nodule', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 931731,WA,33.0,F,"Extreme arm fatigue and limited range of motion, hives and flushing of face and ears",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/20/2020,1.0,PVT,"B12, vegan multivitamin, vitamin D with calcium and magnesium",None,None,,"Dairy, gluten, latex, bee stings,","['Flushing', 'Joint range of motion decreased', 'Muscle fatigue', 'Urticaria']",2,PFIZER\BIONTECH,SYR 931732,UT,67.0,F,"welty rash appeared Friday night. very uncomfortable and itchy, clothing swapped, was gone by morning. Later in the morning, reappeared, mainly on back of thighs and rear end. took 2 tablets of 25mg Benadryl. took a n ap, and rash is gone again.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/08/2021,3.0,PHM,levothyroxine,none,none,,none known,"['Feeling abnormal', 'Hyperhidrosis', 'Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 931734,AL,42.0,F,"Rash and swelling around mouth, eyes, and behind ears",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/05/2021,6.0,WRK,,,,,,"['Circumoral swelling', 'Rash', 'Swelling']",UNK,PFIZER\BIONTECH, 931735,AZ,59.0,F,"Moderate to severe headache, ""foggy"" thinking - felt as though it was difficult to think or process what others were saying. I could not think clearly and made simple but yet important mistakes. I also felt moderately dizzy, especially standing up. No appetite. These symptoms lasted until Wednesday, Jan 6th, at 1730. At 1730 I suddenly felt clear headed and coherent. Duration of symptoms was 49 hrs. The sudden clarity and no longer dizzy was interesting and unexpected and noticeable. The symptoms were fast onset and sudden termination. Only a mild headache for an additional 24hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,Levothyroxine in AM Bupropion (150mg) in AM Methylphenidate ER (20mg) in AM,None,None,,None,"['Decreased appetite', 'Dizziness', 'Dizziness postural', 'Feeling abnormal', 'Headache']",1,MODERNA,SYR 931736,IN,38.0,F,"Right middle toe started with severe itching. It turned red and slightly swollen. 2 days later, 2 small pustules appeared on top of the toe. Only 1 toe has ever been affected.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/19/2020,12/30/2020,11.0,PVT,PROVIGIL; Meloxicam; Bupropion; Fluoxetine; Aspirin; Vitamin D,None,Anxiety/depression; Sleep disorder,,Penicillin,"['Erythema', 'Pruritus', 'Rash pustular', 'Skin swelling']",1,PFIZER\BIONTECH,IM 931737,VA,61.0,F,Rash at injection site. Itching comes and goes. Consulted pharmacist no treatment recommended. Using topical Benadryl cream for itchiness. Arm pain but may he related to exercise.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/09/2021,7.0,OTH,Prempro 0.3 mg/1.5 mg Amlidopine 5mg OTC calcium and Vitamin D 600mg. Had an MRI yesterday at 11:15 am with contrast.,Desmoid tumor Torn medial gastrocnemius muscle (left leg),Raynaud?s disease Childhood asthma,,Lima beans NSAIDS Leaving Amoxicillin Generic plaquenil Bee stings,"['Injection site rash', 'Pain in extremity', 'Pruritus']",1,MODERNA,SYR 931738,KS,25.0,M,"After receipt of the vaccine, I developed a low grade fever the next day (1/7/21) that persisted throughout the day until it progressed into a fever of at least 101.3 F at night. It might have been higher, but that was the best reading I could get. It felt like the fever came on extremely fast bc all of a sudden I started shaking vigorously with rigors and chills. I couldn't get out of bed without experiencing the most uncomfortable chills I've ever experienced. I previously had Covid in early November, and this fever felt worse than what I experienced when I actually had Covid. Also, I experienced moderate to severe pain in my left arm on 1/7/21 at the injection site, which was far worse than any other muscle soreness I've experienced from any other vaccine I've received. The hour preceding the sudden fever attack, my left arm was feeling blazing hot, looked a little red, and swollen. I also experienced a strange allodynia type pain, whereby parts of my body hurt from simply touching them. Although I did not develop a significant rash, I experienced pruritus all over my body, predominantly affecting the areas around my ankles and wrists. I have a hx of multiple dermal filler injections in my lips. I don't think I had any problems with my lips after the injection. But other symptoms that I developed included a tickle in my throat and some shortness of air. On 1/8/21, I woke up drenched in sweat so I presumed that I broke my fever while sleeping. I have felt much better ever since. I'm a nurse practitioner student, and I had to miss a day of clinical on 1/8/21 bc of this reaction to the vaccine. I used ibuprofen the morning on 1/7/21 and Tylenol at night on 1/7/21 to bring down my fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"Vyvanse, Celexa, intranasal flonase, multi-vitamin, propranolol",none,"ADHD, anxiety/depression, seasonal allergies",,"Truvada - mild reaction, pruritus without significant rash","['Allodynia', 'Chills', 'Dyspnoea', 'Erythema', 'Feeling abnormal', 'Feeling hot', 'Hyperhidrosis', 'Impaired work ability', 'Injection site pain', 'Myalgia', 'Night sweats', 'Oropharyngeal discomfort', 'Peripheral swelling', 'Pruritus', 'Pyrexia', 'Tremor']",1,MODERNA,IM 931739,IN,23.0,F,I was congested when I woke up the day after the vaccination. I blew my nose and my mucous was tinged red with blood. My mucous returned to normal after a couple of hours of being awake. I have no history of nosebleeds and have no other explanation for the nose bleed except a possible vaccination side effect.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Modafinil 100 mg daily. Lexapro 10 mg daily. Claritin 10 mg daily,,,,,"['Epistaxis', 'Respiratory tract congestion']",1,PFIZER\BIONTECH,SYR 931740,UT,36.0,F,Epsilateral painless supraclavicular lymph node,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,WRK,,No,Seasonal allergies,,None,['Lymphadenopathy'],UNK,PFIZER\BIONTECH, 931741,OH,55.0,F,"Dysgeusia, Fever 101F and Fatigue for 36 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,None,None,None,,None,"['Dysgeusia', 'Fatigue', 'Pyrexia']",1,MODERNA,SYR 931742,CA,41.0,F,"Recipient came in c/o feeling ""flushed"". Denies asthma, allergies. lightheadedness. Color pink, no hives ,uticaria, SOB. @0916 VS=88-116/60-22 lungs ausc. clear. @ 0920 stated she felt increase in HR. HR = 102 RR=24 116/70 . HR 104. No c/o nausea. color continues to remain pink, lungs clear. continued observation. at 0940 HR decreased to 71, which she states is normal for her. RR-16 115/80. States she feels ""better"". Given instructions to call 9-1-1 if s/s of anaphylaxis or if symptoms return to notify PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,"Nature Bounty hair, skin, and nails vitamins, turmeric 1000mg, fiber.",No,Anxiety,,No,"['Flushing', 'Heart rate increased']",1,PFIZER\BIONTECH,IM 931743,IN,58.0,F,"Covid 19 Moderna- I had right arm pain, stuffy head, cough, fever, chills, all over body aches, weakness, tired, feeling terrible.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Aspirin 81 mg daily, B 12 1000 mcg daily, D 3 1000 mg daily",none,none,,"Sulfa, Duricef, Neosporin, Bacitracin, Latex, Oranges","['Asthenia', 'Chills', 'Cough', 'Fatigue', 'Feeling abnormal', 'Head discomfort', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SC 931744,GA,68.0,M,"Moderna Vaccine 1/6/21 at 9:15 am. At 4:00 that afternoon, patient started complaining of slight cough and diarrhea. Later that evening, patient stated he started with body aches, shortness of breath, chilling, and inability to sleep. Patient did not take temperature that night. The morning of 1/7/21, patient had 100 degree F temp, feeling exhausted, with nausea. Patient went to work but was unable to stay due to exhaustion and nausea. Patient went home and slept most of day. Patient went to work on 1/8/21, only complaining of headache. Pt feeling much better on 1/8/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,,,"Diagnosed with Covid 7/24/21 , hospitalized 7/24 - 08/14, received plasma in hospital, discontinued oxygen end of October 2020",,denies,"['Body temperature increased', 'Chills', 'Cough', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Headache', 'Impaired work ability', 'Insomnia', 'Nausea', 'Pain']",1,MODERNA,IM 931745,IL,46.0,F,"1st Day- Arm Neck Pain 12/31/2020 Loss of Appetite, Dizzy-current",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/31/2020,10.0,PVT,Labetalol Xyzal Singulair Ozempic Jardiance Biotin B Complex Daily Vitamin Vitamin D Vitamin C,none,Diabetes Type 2 HBP Allergies,,Sulfites Metformin Toradol Codeine,"['Decreased appetite', 'Dizziness', 'Neck pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 931746,KS,38.0,F,"Post vaccine 12 hours fever of highest 102.3 F, resolved by 8 am Wednesday 1-6-21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Birth control,Covid 13 days prior,No,,Penicillin,['Pyrexia'],1,PFIZER\BIONTECH,IM 931747,WA,37.0,F,"I reported in V-Safe that I had pain for the first 3 days. What I failed to report, and now realize, is that I had a fever in the first 24 hours and a hive/red welt still exists at the injection site. The red welt is slightly swollen and very warm to the touch. It is approximately 3"" x 5"" oval shape around the injection site. It has persisted for 8 days since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/03/2021,3.0,PVT,"Fish Oil, Vitamin D, Cetirizine Hydrochloride (allergy medication daily)",None,None,,"Amoxicillin, Penicillin, sulfa-based antibiotics, latex, bee venom, shrimp","['Injection site erythema', 'Injection site reaction', 'Injection site swelling', 'Injection site urticaria', 'Injection site warmth', 'Pain', 'Pyrexia', 'Urticaria']",1,MODERNA,SYR 931748,NY,40.0,F,"dizziness, fever, chills, tachycardia > 90 bpm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,denies,denies,seasonal allergies,,denies,"['Chills', 'Dizziness', 'Pyrexia', 'Tachycardia']",1,PFIZER\BIONTECH,IM 931749,CA,36.0,F,"I had general side effects within 24 hours of receiving injection (injected on Dec 30): increasing arm pain too hurt to move, body aches, 100 degree fever 12 hours later that lasted about 5 hours, tired & weak. I woke up with adverse effects on Jan 8: itchy raised rash next to injection site; ongoing today, Jan 9: rash has flattened, but remains warm, pink & itchy - appears like cellulitus. Also arm has remained slightly sore since Dec 30.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/08/2021,9.0,PVT,None,None,Chronic Hep B,,None,"['Asthenia', 'Fatigue', 'Injection site reaction', 'Injection site warmth', 'Pain', 'Pain in extremity', 'Pyrexia', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",1,MODERNA,IM 931750,OR,60.0,F,"Fever for over 4 days of 101...chills, shaky, sore throat, severe headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,UNK,multi vitamin synthroid 50,none,none,,none,"['Chills', 'Headache', 'Oropharyngeal pain', 'Pyrexia', 'Tremor']",1,MODERNA, 931751,CA,44.0,F,I treated the patent in the emergency department today with what appears to be cellulitis or a local inflammatory reaction on her left upper arm around the injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,,,,,,"['Injection site cellulitis', 'Injection site inflammation']",1,MODERNA,IM 931752,MN,60.0,F,"Patient received the Moderna COVID-19 vaccine at her place of employment as a phase 1A essential frontline healthcare worker in a skilled nursing LTC facility on January 6 2021. The day after receiving the vaccine (1-7-21), she started to feel increased shortness of breath (she has shortness of breath at baseline due to chronic health conditions- CHF, asthma), a heavy feeling in her chest/lungs, sweating and fatigue. She contacted the pharmacy on January 8th, as we were the entity that vaccinated her to ask about vaccine reaction. Due to her medical history of MI and CHF, pharmacist did not want to dismiss this as a reaction to the vaccine, and recommended that she contact her doctor for further guidance. She did reach out to her care team, and ended up going to the emergency room for testing due to cardiac history and presentation of symptoms. She had diagnostic testing done (see item 19) and the ER doctor attributed her symptoms to an exacerbation of CHF and asthma, noting that vaccine involvement in the worsening of her symptoms can not be ruled out. Treatment/discharge instructions include: follow up with cardiology/pulmonology, furosemide dose was increased, potassium supplement restarted, and instructed to use inhalers already on hand when needed. As of time of report on January 9 2021, the patient was resting at home, doing well except still having symptoms upon exertion.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,FUROSEMIDE POTASSIUM CHLORIDE MONTELUKAST CARVEDIOLOL ASPIRIN ATORVASTATIN LISINOPRIL/HCTZ VITAMIN D ALIVE WOMEN'S MULTIVITAMIN KETOGENIC HEALTHY WEIGHT LOSS SUPPLEMENT COFFEE CLEANSE SUPPLEMENT ARNUITY INHALER PSEUDOEPHEDRINE OMEPRAZOLE A,SEE ITEM 12,"CHF, ASTHMA, HTN, CAD (HISTORY OF HEART ATTACK, STENT)",,NONE,"['Asthma', 'Cardiac failure congestive', 'Chest X-ray', 'Chest discomfort', 'Condition aggravated', 'Dyspnoea', 'Electrocardiogram', 'Fatigue', 'Hyperhidrosis', 'Myocardial necrosis marker', 'SARS-CoV-2 test', 'Ultrasound scan']",1,MODERNA,IM 931753,CO,73.0,M,"Sore arm at injection site (I flinched) and fatigue, nausea, muscle aches, joint pain, generally felt ill, all mostly resolved after 28 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,Levothyroxine 125 Tablet Duloxetine Hcl Dr60 Mg Capsule Trazodone 100 MG Tablet,None,Bad back,,None,"['Arthralgia', 'Fatigue', 'Injection site pain', 'Malaise', 'Myalgia', 'Nausea']",1,MODERNA,IM 931754,NJ,59.0,F,"Received vaccine 1/6/21 approx. 2PM. On 1/7/21, felt severe body aches & pains worsening throughout the day. My right arm at injection site was sore, swollen, red & tender. By 6PM, had fever of 101.7. Took 3 maximum strength Tylenol to control fever. Still had Temperature of 101.7 a few hours later & took more Tylenol. Couldn?t stop shaking from fever. Fever kept returning when Tylenol wore off. Last fever was 101.4 on Friday 1/8 at 12PM. Took Tylenol every 4 hours. Still had severe body aches throughout entire day/nite of 1/8. No fever Saturday 1/9 but still have body aches & pains. Injection site still red, swollen, tender & sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,UNK,None,None,None,,None,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Pain', 'Pyrexia']",1,MODERNA,IM 931755,MT,41.0,F,"2nd Pfizer vaccine was given on Thursday Jan. 7th around 1240pm. That evening I experienced expected muscle aches, chills, headache, fatigue. The next evening, Jan 8th I experienced chest pain which felt like heartburn or gastritis (which I do not typically have) in addition to the muscle aches, chills and headache returning. The morning of Jan 9th I woke up with a swollen face in addition to ongoing body aches, fatigue and headache and took 50mg of Benadryl and went to urgent care for evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"ibuprofen PRN, tylenol PRN, Benadryl PRN.",none,none,,mango- rash around mouth,"['Chest pain', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pain', 'SARS-CoV-2 test', 'Swelling face']",2,PFIZER\BIONTECH,IM 931756,CA,45.0,F,"Patient received Moderna covid vaccine. Within 5-10 minutes patient stated feeling ""heart racing"" and slight tingling to hands and feet. RN had patient lay down on gurney, loosened constricting clothing. Given water and trail mix. 1021- 134/88; hr 72; 99%O2 1026- 116/66; hr 98; 98% 1048- given 25 mg benadryl PO per verbal order from Dr 1050- 128/68; hr 101; 100% 1107- 116/59; hr88; 100% � 1130- patient discharged with friend. States feeling better. Instructed to call clinic advice line if symptoms resume.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,OTH,Outpatient Medications Venlafaxine (EFFEXOR) 25 mg Oral Tab buPROPion (WELLBUTRIN) 75 mg Oral Tab Benzonatate (TESSALON PERLES) 100 mg Oral Cap Facility Administered Medications diphenhydrAMINE Cap 25 mg (BENADRYL),Problem List Collapse by Default Collapse by Default GENERALIZED ANXIETY DISORDER MIGRAINE WO AURA BILAT BENIGN PAROXYSMAL POSITIONAL VERTIGO � SEASONAL ALLERGIC RHINITIS � PATELLOFEMORAL DISORDER OF LEFT KNEE � DERMATOGRAPHIC URTICARIA � TINEA VERSICOLOR � PERIMENOPAUSAL � LEFT COMPLEX OVARIAN CYST,,,Allergies AmpicillinHives Penicillins ClassHives Sulfa Class [Sulfa (Sulfonamide Antibiotics)]Hives Celexa [Citalopram Hydrobromide] Co-trimoxazole,"['Palpitations', 'Paraesthesia']",1,MODERNA, 931757,TX,35.0,F,"Worsening pain in left arm, nausea and vertigo only on day 1",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,"Zoloft, magnesium, vitamin d, prenatal",None,Epilepsy Pulmonary embolism,,None,"['Nausea', 'Pain in extremity', 'Vertigo']",1,MODERNA,IM 931758,NY,27.0,F,"Moderate Headache and fatigue throughout day. Chills, generalized feeling of being unwell.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Sertraline (50MG) Vitamin D Supplement Lo Lo Estrin,,,,,"['Chills', 'Fatigue', 'Headache', 'Malaise']",2,PFIZER\BIONTECH,IM 931759,WI,50.0,F,"Patient was given the first COVID-19 vaccination at approximately 1254 today in her left deltoid. She approached writer at 1310 in no apparent distress. She voiced symptoms that were concerning to her. She indicated about 5 minutes after she received the injection, her tongue felt like it was burning and tingling. She also stated her chest was burning. Denies every having these symptoms ever before. She currently denied shortness of breath, chest pain, shoulder pain, nausea, or throat swelling. No changes in voice were observed by writer. Last time patient ate was between 0930 and 1000 this am. Patient shared that she was feeling anxious about having the vaccine and wonders if this is the reason why she is having the symptoms. Vitals taken, all within normal range. � Patient encouraged to remain for 30 for observation. No further concerns were verbalized to writer during her stay. Patient was encouraged to call 911 if she develops shortness of breath, chest pain, throat swelling or other concerning symptoms after she leaves. Patient verbalized understanding and was agreeable with plan.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,unknown,unknown,HTN CKD IgA nephropathy renal hematoma elevated hemoglobin hematuria proteinuria,,NKA,"['Anxiety', 'Chest pain', 'Laboratory test normal', 'Paraesthesia oral', 'Tongue discomfort']",1,PFIZER\BIONTECH,IM 931760,CA,44.0,F,"1 day after moderna vaccine shot, I developed slight rash/redness near the injection site. It went away after 2 days. And then 1 week after the vaccine administration , I developed a big redness /swelling/pain/itchiness near the injection site. I also had some chills low grade temp, fatigue, excessive sleepiness on that day. I went to ER 2 days after because the redness got bigger and painful. ER doctor said it?s possibly cellulitis and she prescribed antibiotics",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/07/2021,7.0,PVT,None,Had a miscarriage at 12/19/2020,None,,Benadryl,"['Chills', 'Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Somnolence']",1,MODERNA,IM 931761,OR,40.0,F,"Every morning, following the vaccination, I woke up with a moderate headache. Tuesday through Thursday I was able to control the headaches with 600 mg of Ibuprofen. But Friday I had a migraine with light sensitivity and it was not relieved by using Ibuprofen or Aleve. It finally spontaneously resolved at around 1330. I've been otherwise fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,UNK,"Claritin, omega 3, b complex, glucosamine/msm, coq10, 5 htp, st John's wort, & Ashwagandha",None,Mild asthma & eczema,,NKA,"['Headache', 'Migraine', 'Photophobia']",1,MODERNA,IM 931762,OH,36.0,F,Fever started at 3:00pm. Nausea (2x vomiting) and diarrhea (until the evening of the following day). Fever broke after 4 hours. Headache and muscles aches persisted for 24 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,amoxicillin,"['Diarrhoea', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting']",1,MODERNA,IM 931763,TX,47.0,F,"The morning of January 8th I woke to a red splotch on my left arm at injections site. As the day progressed it became more itchy and hot to the touch. It peaked over night, but by the morning of January 9th was gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/08/2021,8.0,PHM,"Multi Vitamin, birth control, ambien, levothyroxine",none,none,,pcn,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 931764,NY,22.0,F,"Vagal response 1minute post vaccine..Dizzy and pale, hypotensive , all symptoms resolved within 5 minutes.. monitored for 30 minutes before d/c.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,,,,,,"['Dizziness', 'Hypotension', 'Pallor', 'Presyncope']",1,MODERNA,IM 931765,CA,43.0,F,"Moderna COVID 19 Vaccine EUA: 15 mins after administration, I felt dizzy and cold, last for an hour then resolved. 14 hours after administration I had fever, chills, headache and sever body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,WRK,None,None,Hypertension,,None,"['Chills', 'Dizziness', 'Feeling cold', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 931766,AZ,42.0,M,"Fever, uncontrolled rigors, extreme/uncomfortable aching of the feet and hands that awoke from sleep",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Pain in extremity', 'Pyrexia', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 931767,CT,42.0,F,At day 8 injection site pain and extreme itching at the site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/07/2021,9.0,WRK,"Ambien 10mg, melatonin, Zyrtec, multivitamin",None,None,,None,"['Injection site pain', 'Injection site pruritus']",1,MODERNA,IM 931768,IL,46.0,F,"01/07/2021 8:30PM-1st chills- Uncontrollable shaking for 2-3 hours.(felt like I was running a marathon in bed) Temp 99.5 9:30PM-Temp of 101 then it went to 102 within an hour. Headache. 10:30 took Tylenol 11:30 Temp 101.5 stopped shaking but still have a temp and muscle aches- probably from the shaking. 12:30 (01/08/2021) Temp 101. Fell asleep 4:30 Temp 100 8:30 Temp 99.5 Still have a headache and muscle pain, and upper back pain Tired, but probably just from roller coaster ride. 01/08/2021 Most of the day and night had low grade fever 99.5-100.7 , headache and sweats 01/09/2021 No Fever, but still have the occasional seats and dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Labetalol Xyzal Singulair Ozempic Jardiance Biotin B Complex Daily Vitamin Vitamin D Vitamin C,Dizzy from last Covid Vaccination on 12/21/2020,Diabetes Type 2 HBP Allergies,,Sulfites Metformin Toradol Codeine,"['Back pain', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Pyrexia', 'Tremor']",2,PFIZER\BIONTECH,IM 931770,WA,33.0,F,Sore L Deltoid Moderate low back pain,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PHM,Acetaminophen 650mg PRN alternating with ibuprofen 400mg PRN,None,Migraines Breastfeeding,,Low blood sugar with epinephrine No hx of anaphylaxis,"['Arthralgia', 'Back pain']",2,PFIZER\BIONTECH,IM 931771,AZ,27.0,F,Chest pain and palpitations,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,"Microgestin, Vitamin D, Biotin, Zyrtec",None,PCOS,,"Medrol, Paxil, Nuva Ring","['Chest pain', 'Palpitations']",1,MODERNA,IM 931772,OH,30.0,F,Anaphylaxis,Not Reported,,Yes,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,MIL,OTC multi-vitamin,none,Had COVID 19 diagnosed October 2020,,Ambien-visual hallucination Bee/wasp venom (localized swelling),['Anaphylactic reaction'],1,MODERNA,IM 931773,NC,46.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Fever (Tmax 101.3), generalized myalgia, chills, headache, fatigue - these symptoms began to occur about 18 hours after the 2nd injection in the series and last about 18 hours. Treated successfully with ibuprofen. Feeling much better by the following morning with only fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,,None,"Hypertension, migraines, difficulty sleeping, GERD",,None,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931774,TX,49.0,F,"After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light headed and as if I was drunk my legs feel real week they took me outside so I could catch some fridge fresh air and they set me down on a chair I was very dizzy my legs and my knees felt like I couldn't stand up and they were very weak I kept seeing a the rails double vision and I started to have a tightness in the back of my neck I felt they warrant come over my head and my forehead got very very cold And then I felt as I was gonna blackout and pass out and I was gasping for air and suddenly my tongue went into a spasm and it went to the top of my the roof of my Roof of my mouth and I couldn't breathe and I was able to send a message for someone to come and help me as I was sitting there by myself they rushed over by now looking at my text message it was for 02 which was within 15 minutes of the vaccine when I had my 1st episode and then minutes after that 3 more came with the same oh unable to swallow I lost the ability to swallow and my tongue fell like I had no control it was just automatically stuck to the roof of my mouth.. Upon the arrival of Ems I was told there was no treatment and there was nothing they could do told me to wait 24 to 48 hours in the symptoms should subside it's been over 72 hours in the symptoms are still occurring. I continue to feel dizzy light headed and now have high blood pressure which was not present before visit ER prescriptions for steroids with issued, I Told to go home and rest. Followed up with family doctor in the morning and was told it was not an allergic anaphylactic reaction probably more so neurologically ransom blood tests waiting for results continue to have loss of control over tounge spasms unable to eat Accompanied by fatigue dizziness and high blood pressure",Not Reported,,Not Reported,Not Reported,,Yes,N,01/06/2021,01/06/2021,0.0,SEN,None,No,No,,Peanut Phenergan,"['Blood test', 'Diplopia', 'Dizziness', 'Dysphagia', 'Dyspnoea', 'Dysstasia', 'Fatigue', 'Feeding disorder', 'Feeling cold', 'Feeling drunk', 'Hypertension', 'Muscle tightness', 'Muscular weakness', 'Neurological symptom', 'Tongue movement disturbance', 'Tongue spasm']",1,PFIZER\BIONTECH,SC 931775,WA,65.0,F,Palpitations and accelerated hypertension. Blood pressure and heart rate remained high after an hour of monitoring so was sent to ED in same facility for follow up. Heart rate was 103 and Blood pressure was 157/85 (My normal BP is 110/62).,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Aspirin 81 mg, COQ10, Allegra, Crestor, Magnesium, Vit D3",None,Hx CAD with cardiac stent 2002 with no issues since that date.,,"Contrast dye (hives), Codeine (rash), lactose, gluten","['Accelerated hypertension', 'Electrocardiogram normal', 'Heart rate increased', 'Hypertension', 'Palpitations', 'Troponin normal']",1,MODERNA,SYR 931777,MD,53.0,F,101 fever for 3 days Chills Severe Headache Severe Body aches Sweating Tired Fatigue Couldn't function for 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,,,,,,"['Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Pain', 'Pyrexia']",1,MODERNA,SYR 931778,AK,51.0,F,"Patient developed tachycardia, vomited and trouble breathing",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,OTH,"ASA, Atorvastatin, bupropion, budesonide nasal, calcium carbonate, vit D, plavix, conj estrogens, flexeril, diltiazem, colace, gabapentin, hydroxyzine, HCTZ, lisinopril, loratidine, metformin, pantoprazole, maxalt, rizatriptan, selenium sul",,"DM, HTN, Allergic rhinitis, depression, eczema, GERD, dyslipidemia, migraines, chronic kidney disease, anemia, Chronic kidney disease",,"keflex, indomethacin","['Dyspnoea', 'Tachycardia', 'Vomiting']",1,PFIZER\BIONTECH,IM 931779,TX,38.0,F,Employee stated she got severe muscle selling and body aches the day after and had to go to ED for visit. She stated she was bent over having trouble walking. No active sx day of vaccine noted during observation time at da of vaccination. All handouts for fact sheet and V-Safe give prior to vaccine and employee was observed for appropriate time frame after Vaccine. Employee doing fine after couple of days from start of reaction. Employee went to hospital ED.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,UNK,,,,,,"['Muscle swelling', 'Pain']",UNK,MODERNA,IM 931780,IL,50.0,F,"I started to have mild symptoms (malaise, flush feeling and then numb, tingling, weak hands followed by joint pain) in the afternoon of 1/7. The symptoms progressively worsened into what my husband (an immunologist) called an intense hyperimmune response. I had severe COVID symptoms (intensified from my experience having the virus in Sept): fever 100-102, flushed face, intense muscular and some neurologic symptoms--joint arthralgia and myalgia, headache, shivers/rigors, extreme weakness (especially my hands) and later I could barely stand or walk, glandular pain with minor swelling (axillary and neck), nausea, and my hearing was temporarily diminished--nearly lost for a few minutes; tylenol 500 mg taken the night of 1/7. The intense symptoms have subsided. Currently I am tired, weak, achy, and afebrile (last ibuprofen 200 mg taken last night). My hands remain weak.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,None,None,Asthma,,Codeine,"['Arthralgia', 'Asthenia', 'Autoimmune disorder', 'Chills', 'Dysstasia', 'Fatigue', 'Flushing', 'Gait disturbance', 'Headache', 'Hypoacusis', 'Hypoaesthesia', 'Lymph node pain', 'Lymphadenopathy', 'Malaise', 'Muscular weakness', 'Myalgia', 'Nausea', 'Neurological symptom', 'Pain', 'Paraesthesia', 'Pyrexia']",1,MODERNA,IM 931781,IL,25.0,F,"headache, vomiting, and lightheaded",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,"Synthroid, Tylenol, Excedrin",,"Hypothyroidism, Celiac Disease, Migraines",headache to the first COVID vaccine,Wheat,"['Dizziness', 'Headache', 'Vomiting']",2,PFIZER\BIONTECH,IM 931782,NJ,65.0,F,Pain Right Arm Headache Pain r side of face and r eye,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,UNK,,,,,,"['Eye pain', 'Facial pain', 'Headache', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 931783,IN,41.0,F,"Pfizer-BioNTech COVID-19 Vaccine- Woke up at 01:30 with extreme chills, body aches & fever 101.8. Took 2 Tylenol & woke up at 0400 with a fever of 102.6, chills, body aches & horrible headache. I also had no appetite, nausea & developed fever blisters on lower lip. Lasted until Tuesday 12/29 & ended up going to the ER because the headache was so horrible & would not go away.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/27/2020,1.0,PVT,"Lisinopril 10 mg x1 daily Sertraline 100 mg x 1 daily EZ Tears x 1 in am, x 1 pm IVIG x 1 time each month",,Immunocompromised due to chemotherapy for Non-Hodgkins Lymphoma,,Clindamycin Betadine Chloraprep,"['Chills', 'Decreased appetite', 'Headache', 'Nausea', 'Oral herpes', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 931784,CA,,U,"Excessive Fatigue, sore arm, sore hips & thighs",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,PVT,,,,,,"['Arthralgia', 'Fatigue', 'Pain in extremity']",1,MODERNA,IM 931786,MI,49.0,F,"Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphoresis, then unable to stand, fell to the floor then could not see at all, everything was black, also unable to speak, sudden onset of shortness of breath, central chest pain, pain to shoulders and neck. Ears ringing, pain to back of head. Approximately 15 min later was able to speak and crawl to edge of bed. Sweating remained at this time along with extreme weakness, lightheaded and nausea. Heart rate 118, oxygen was 96% by finger oximeter. 10 minutes later dressed with assistance and able to ambulate independently but slowly to truck to be taken to ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/09/2021,4.0,PVT,81 mg aspirin Vitamin D Multivitamin,None,None,,None,"['Aphasia', 'Arthralgia', 'Asthenia', 'Chest pain', 'Dizziness', 'Dizziness postural', 'Dyspnoea', 'Dysstasia', 'Headache', 'Hyperhidrosis', 'Laboratory test normal', 'Nausea', 'Neck pain', 'Tinnitus', 'Visual field defect']",1,PFIZER\BIONTECH,IM 931788,MS,64.0,F,"Nausea, diarrhea, low grade fever. Lasted 4 days, treated with Zofran",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/30/2020,8.0,UNK,"Synthroid, losartan, maxzide, pravastatin, aspirin, zinc, vit C, vit D3, multivitamin, pepcid, Zyrtec, omega 3",None,"Hypertension, thyroid cancer, high cholesterol, migraine",,"Ceclor, cipro , flagyl , crestor, ibuprofen","['Diarrhoea', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,SYR 931790,IN,39.0,M,fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,none,none,none,,"penicillin, bananas",['Fatigue'],1,PFIZER\BIONTECH,IM 931791,TN,49.0,F,rash all over body,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PUB,cymbalta metoprolol gabapentin trazadone telmisartan,none,brain anuerysm,,nka,['Rash'],1,MODERNA,IM 931792,GA,39.0,F,"One week after the injection my arm began itching. It is red, elevated and warm. Estimated date of delivery: August 22, 2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,,,,,NKA,"['Erythema', 'Feeling hot', 'Pruritus']",1,PFIZER\BIONTECH,SYR 931793,NM,26.0,F,Pain and swelling in left arm and axilla that radiates to her back for 9 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,PVT,Montelukast 10mg tablet Ogestrel 0.5mg-50mcg tablet Proair HFA 108 MCG/ACT inhaler Topiramate 25mg tablet,None,Migraines Asthma PTSD Major Depressive Disorder,Rash from Flu Vaccine,Aspirin-Throat closes Ciproflaxacin-Fatigue Epinephrine-Asthma attack,"['Axillary pain', 'Pain in extremity', 'Peripheral swelling']",2,PFIZER\BIONTECH,IM 931794,NY,67.0,M,"fatigue, nausea and terriblevomiting with chills and shake",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PUB,none,none,none,,none,"['Chills', 'Fatigue', 'Nausea', 'Tremor', 'Vomiting']",1,MODERNA,SYR 931795,AK,34.0,F,"I have an infection at the injection site. I believe this could happen with any vaccine but wanted to report just in case. I am experiencing a large circle (a little smaller than a baseball) of swollen red skin that is painful around the injection site. Last night, the lymph nodes in my armpit, neck and collar bone on the right side swelled up and were painful. I feel fatigued.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,PVT,"Zoloft, multivitamin, ibuprofen",Depression,Pre-diabetes,,None,"['Fatigue', 'Injection site erythema', 'Injection site infection', 'Injection site pain', 'Injection site swelling', 'Lymph node pain', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 931796,CA,56.0,M,"Fever, body aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,None,None,None,Second dose of shingles vaccine caused flu like symptoms,None,"['Fatigue', 'Pain', 'Pyrexia']",1,MODERNA,IM 931797,KY,38.0,F,"Woke up at 2:30 am feeling nauseous, broke out in cold sweat, got out of bed, went to restroom, everything went black and felt like I was going to pass out. Husband got to me and laid on the floor. Never passed out completely, but it was a very weird and odd feeling. Felt better after about 20 mins. Have felt great since. So did not go to primary care physician but felt the need to report.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,UNK,Citalopram 10mg,None,None,,None,"['Cold sweat', 'Dizziness', 'Nausea']",1,PFIZER\BIONTECH,SYR 931798,CT,57.0,F,"Four days after vaccine, I began to feel sick, weak, headache, bodyaches, fever of 100.4, and thick nasal/sinus mucus.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/08/2021,4.0,SEN,"Synthroid, Combipatch, wellbutrin, vitamin D",None,Environmental allergies,,"Avalox, erythromycin, macrobid,","['Asthenia', 'Headache', 'Increased viscosity of upper respiratory secretion', 'Malaise', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 931799,PA,45.0,F,"Severe headache, Chills Gastro intestinal side effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,WRK,None,None,None,,None,"['Chills', 'Gastrointestinal disorder', 'Headache']",1,PFIZER\BIONTECH,SYR 931801,,49.0,F,"Day one I had a headache. Wouldn?t go away with any medication. Day 6 still had headache turned into migraine and severe exhaustion. Chills, diarrhea and nausea. Day 10 woke up in the middle of the night with fever 99.6. At this point I went and got tested for Covid and it was negative. Finally on 09/09/2021 woke up without a headache but it came back later on.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,UNK,"Seroquel, tegretol, proprananol",None,None,,"Lamictal, maxalt, sulfa","['Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Migraine', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 931802,IN,33.0,F,"Arm pain and swelling at injection site- pain required ibuprofen to dull. Couldn?t lift or lay on injection site without significant pain. With 36 hours, developed chills, muscle aches, and fatigue in addition to the injection pain. Within 48 hours, chills subsided but fatigue, muscle aches, and pain continued. Developed shoulder and neck pain along with significant dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Pristiq 100mg,None,,,None,"['Arthralgia', 'Chills', 'Dizziness', 'Fatigue', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Neck pain', 'Pain', 'Sleep disorder']",1,MODERNA,SYR 931803,MT,41.0,F,"Tiredness, headache, nausea, vomiting, welt at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,OTH,Spironolactone,None,None,,None,"['Fatigue', 'Headache', 'Injection site reaction', 'Nausea', 'Urticaria', 'Vomiting']",1,MODERNA,IM 931804,WV,60.0,F,"Body aches and chills began 1/5/21 at around 2:30 pm. Left arm below injection site became red, swollen and hot around 7:00pm of that day. All symptoms continued through following day with extreme stiffness and soreness in arm. Area of redness on left arm enlarged over the day and evening. PCP started me on antibiotics and by evening of following day most symptoms were improved. Arm was still red, slightly swollen and itchy. Arm is still red and itchy but has improved today .",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PHM,Levothyroxine Bystolic Escitalopram Alendronate Multivitamin,I had Covid 19 in November.,Hypothyroidism,,NKDA,"['Chills', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Musculoskeletal stiffness', 'Pain', 'Pain in extremity', 'Pruritus']",1,MODERNA,SYR 931805,IL,28.0,M,"Headache, Fever, Fatigue, Photophobia, Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Escitalopram,None,OSA,,Tree nuts,"['Chills', 'Fatigue', 'Headache', 'Photophobia', 'Pyrexia']",2,UNKNOWN MANUFACTURER, 931806,MD,34.0,M,Spastic convulsions that occurred in every muscle in my body lasting for more than 4 hours. Hands now tingle and spasm from time to time.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,UNK,Omeprazole 40 mg,N/a,GERD,,"Penicillan, Ceclor","['Paraesthesia', 'Seizure']",1,MODERNA,SYR 931807,FL,50.0,F,Arm pain and injection site that worsened over 24 hours. I developed swelling of entire upper left arm and severe headache 12/19/20,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,"Tramadol, nuvigil, albuterol, cosyntex which held for 1 month prior to vaccine, tizanidine",None,Psoriatic arthritis Asthma Migraine,Myositis after influenza,Penicillin,"['Headache', 'Injection site pain', 'Injection site swelling', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 931808,WA,63.0,F,Grade 3 local reaction - > 10 cm induration at injection site within 12 hours then gradual resolution over several days. Delayed Reaction: 7 days later > 10 cm erythema developed surrounding injection site with minimal induration. Did not appear infected. Photos taken of both events.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,"Insulin, cyclosporine drops (eyes), escitalopram 20mg, warfarin, hydroxychloroquine 200mg (autoimmune), verapamil 120mg SR, midodrine 2.5mg, topiramate 100mg",sinusitis,"Anticardiolipin antibody syndrome, migraines, Type 2 diabetes, chronotropic incompetence (pacemaker), complex regional pain syndrome, GERD, h/o osteomyelitis, mixed hyperlipidemia, patent foramen ovale,",pneumococcal with local reaction,"Iodine, PCN, Povidone-iodine, shellfish, sulfa, wasp venom","['Arthralgia', 'Body temperature increased', 'Cough', 'Dyspnoea', 'Injection site erythema', 'Injection site induration', 'SARS-CoV-2 test positive']",1,MODERNA,IM 931809,,36.0,F,c/o of flushing and warmth,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,augmentin,"['Flushing', 'Skin warm']",1,MODERNA,IM 931810,OK,26.0,F,"diffuse rash, swelling and wheezing",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,OCP,none,none,,NKDA,"['Rash', 'Swelling', 'Wheezing']",2,PFIZER\BIONTECH,IM 931811,PA,20.0,F,Developed migraine and loss of taste 12/30/20 (currently being tested for COVID-19). Developed right (side of injection) axillary pain 1/2/21 which lasted several days. Hives developed on 1/7/21 - ordered Benadryl without relief. Went to ER 1/9/2021 for worsening hives - Pepcid and prednisone ordered.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,WRK,,,,,,"['Ageusia', 'Axillary pain', 'Migraine', 'SARS-CoV-2 test', 'Urticaria']",UNK,MODERNA, 931812,KY,50.0,F,"Severe muscle aches, body aches, chills, fever (100.8 F), extreme fatigue lasting 2.5 days. Treatment: ibuprofen and acetaminophen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,None,"Hiatal hernia, hypertension, chronic muscle pain",,"Sulfa, Latex, Gluten","['Chills', 'Fatigue', 'Myalgia', 'Pain', 'Pyrexia']",1,MODERNA,IM 931813,MA,52.0,F,"Body aches, headache, shaking chills and fever (102.6). Treated with Tylenol, rest and fluids. Symptoms lasted 60 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Multivitamin and Vitamin D3,None,None,,None,"['Chills', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931814,OH,70.0,F,"Fever - 100 degree, lasted all day, headache, upset stomach, fatigue, ache in muscles and joints",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,"Metformin, 81mg asprin, prevstatin, lisinapril",Covid-19 - diagnosed December 7th 2020,None,,None,"['Abdominal discomfort', 'Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,SYR 931815,CA,59.0,F,"at 2:40 pm - 10 minutes after receiving vaccine, pt reports nausea and dizzy. 2:47 pm pt drinking water, reports feeling better, declines BP check or evaluation by EMS 2:55 pm BP 17/107 P 74 pt reports feeling better, she reports has history of uncontrolled HTN 3:00 pm BP 163/ 93, P 64 3:10 pm BP 142/87 P 64 pt reports feels fine and would like to go home",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PUB,Atenolol,,Hypertension,,,"['Dizziness', 'Nausea']",1,MODERNA,IM 931816,,30.0,F,Extreme arm pain and paresthesia of 3rd and 4th fingers on injection arm. Inability to move left arm due to such extreme pain. I went to my doctors office a was prescribed a medrol dose pack. That helped but as soon as I finished the pack the symptoms returned.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,PUB,"Xolair, Prozac, adderall",None,"Hashimotos, idiopathic uticaria",,Vancomycin,"['Injected limb mobility decreased', 'Pain in extremity', 'Paraesthesia']",1,MODERNA,SYR 931817,CA,60.0,M,"Mild to moderate dizziness and nausea for three days starting 01/06/2021. Reported it to a advice nurse and a physician on 01/08/2021 . Meclizine and Ondansetron was used immediately. Scopolamine was prescribed by the physician on 01/08/2021, picked and used on 01/09/2021; felt better . Residual dizziness remains after use. P.S. I do have a medical history of BPPV for the last 2-3 years and have been treated for it. Generally speaking my BPPV symptoms resolve themselves quickly after treatment. This current episode has lasted forthree days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/06/2021,14.0,PVT,"Amlodipine, Omeprazole, Glipizide, Lisinopril, Atorvastatin, Cinnamon capsules, Metformin, Meloxicam, Aspirin Low Dose, Sildenafil, Meclizine, Ondansetron, Scopolamine.",None,"Diabetes Type 2, High Cholesterol, High Blood Pressure.","Severe head ache, joint pains, and fatigue for 1 day after vaccination.","Dust, Ambien , Lunesta.","['Dizziness', 'Nausea']",1,MODERNA,SYR 931818,,46.0,M,Patient received 2nd dose of Pfizer covid vaccine. Began to complain of dizziness and tingling in extremities. 1234- 166/95 hr 72 98% 1239- 146/106; 1242- 180/103 1247- 160/98 1317- 168/96 1325- 142/97 � 1255- Called Dr. Patient given 25mg benadryl PO per MD orders. � Patient transported to ED by wheelchair,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,OTH,"Outpatient Medications Pantoprazole (PROTONIX) 40 mg Oral TBEC DR Tab Atorvastatin (LIPITOR) 20 mg Oral Tab blood-glucose meter (OneTouch Verio Flex Start) Misc Kit blood-glucose control, normal (OneTouch Verio Mid Control) Misc Soln","Problem List Collapse by Default Collapse by Default Non-Hospital HYPERTRIGLYCERIDEMIA HTN (HYPERTENSION) GERD (GASTROESOPHAGEAL REFLUX DISEASE) MAJOR DEPRESSIVE DISORDER, RECURRENT EPISODE DM 2 W HYPERLIPIDEMIA DIABETIC FOOT EXAM BASAL GANGLIA CALCIFICATION � ALLERGIC RHINITIS � OVERWEIGHT � JAW PAIN � SLEEP APNEA � VITAMIN D DEFICIENCY � GANGLION CYST OF LEFT WRIST � ERECTILE DYSFUNCTION � INSOMNIA � CHRONIC SINUSITIS � PPD POSITIVE � ANXIETY DISORDER",,,,"['Dizziness', 'Paraesthesia']",2,PFIZER\BIONTECH, 931819,IL,25.0,F,"Patient received the Covid-19 vaccine. She reports symptoms of severe sudden onset of headache, small emesis in waiting area, dizziness -- all starting approximately 10 minutes after receiving second dose of Pfizer Covid vaccine. Vital signs stable at the time: BP 107/92, HR 91, SpO2 99%. patient taken to ED with this RN and ICU RN via cart -- taken to ED room 17. � Upon receiving the first dose, patient stated that she started with a headache approximately 5-6 hours after, when already at home. Patient also stated that she has a history of migraines.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,,,,,,"['Dizziness', 'Headache', 'Vomiting']",2,PFIZER\BIONTECH,IM 931820,MS,32.0,F,"1/5/21 -1700: mild pain at injection site 1/6/21 -0800: low-grade fever; extreme pain in left arm; left arm swelling, redness, and tender to touch; nausea; severe headache, body aches, and fatigue. 1/7/21 -0800: still low-grade fever; slight swelling in left arm; mild body aches and fatigue; redness below injection site. 1/8/21 -0800: redness below injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,L-lysine Zyrtec,COVID-19 Dec. 13th,"Depression, anxiety, IBS-C",,Nkda,"['Erythema', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Nausea', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Tenderness']",UNK,MODERNA,SYR 931821,MT,45.0,M,"Pt received Covid-19 vaccine at 1300. After no reportable symptoms for approximately 2 hours, reported back to immunizations for additional vaccine. After administration of last vaccine, pt leaned head back (pt was seated), eyes rolled in back of head, and appeared pale and diaphoretic. After a few seconds, pt regained consciousness. Pt continued to rest with legs propped up and cold compress on neck. VS were taken following event: BP 115/80. SPO2 93%, T 96.8, R 16. Pt reports hx of ""passing out"" with blood draws and previous vaccinations. Provider visited with pt and was okay to leave facility.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,MIL,Lipitor HCTZ Atorvastatin ASA 81mg Turmeric COQ10 Pantoprazole,Common Cold,HTN High Cholesterol,,NKA,"['Eye movement disorder', 'Hyperhidrosis', 'Loss of consciousness', 'Pallor']",2,SANOFI PASTEUR,IM 931822,TX,35.0,F,"30+ minutes after getting covid vaccine, severe chest tightness, hard time breathing in, was driving home and it kept getting worse. Chest pressure. Stopped in local er and got checked out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,"Clindamycin antibiotic, botox injections for migraines, prescribed 40 different medications, ajovy injection for migraines","Infection in my finger, ongoing unresponsive migraine, low immune response, tetanus shot reaction","Asthma, diabetes, chronic migraines, chronic pain, borderline personality disorder, depression, panic attacks, PTSD, costichondritis, arthritis, low immune system response, insomnia, sleep apnea","Unknown reaction can't remember, 25 and 35, Flu shot, 2011, 2020","Benadryl, iv contrast, flu shot, morphine, respirator, immitrex, vicodin, amovig, plus 2 more before getting covid shot, covid vaccine","['Chest X-ray', 'Chest discomfort', 'Dyspnoea']",1,PFIZER\BIONTECH,IM 931823,TX,66.0,F,"Fever, nausea, body aches, myalgia, shaking x 12 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PHM,Unknown,Unknown,Unknown,,No Known Drug Allergies,"['Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Tremor']",1,MODERNA,IM 931824,NC,43.0,F,"rash on face , loss of taste , and voice , tightness in throat started at 245 .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,SEN,ibuprofen before,,,,"Penicillin, Wellbutrin, Morphine","['Ageusia', 'Aphonia', 'Rash', 'Throat tightness']",1,MODERNA, 931825,NC,42.0,F,"Palpitations, presyncope, tachycardia, elevated blood pressure, sweating, chest pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,WRK,Tylenol,,Asthma,,,"['Blood pressure increased', 'Chest pain', 'Hyperhidrosis', 'Palpitations', 'Presyncope', 'Tachycardia']",UNK,PFIZER\BIONTECH,IM 931826,TX,46.0,F,"Patient began itching after about 10 minutes of having her COVID vaccine. She was being observed and c/o itching. She was observed about another 15-20 minutes. more. She had some redness around injection site and head itching. The itching subsided and she was d/c to go home with instructions for warning signs. She denied any difficulty swallowing, SOB, or other sx at that time. She was given previously the Fact Sheet and V-Safe sheet. She denied any new sx and stated she felt fine. She was given warning signs by self and stated she understood. She stated she had benadryl at home if sx returned she would seek medical attention. Patient returned to work at the hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,UNK,,,,,,"['Injection site erythema', 'Pruritus']",UNK,MODERNA,IM 931827,MA,33.0,M,Arm pain 103.1 fever and chills,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,UNK,Tylenol ibuprofen,Gout,Ischemic optic neuropathy,,NKDA,"['Chills', 'Pain in extremity', 'Pyrexia']",7+,MODERNA,IM 931828,CO,58.0,F,"By midnight after getting the shot, my arm was extremely painful. I iced it through the night, but it didn't help that much. Then the next morning, was very nauseous and started having diarrhea. Remained nauseous and continued having diarrhea for 2 1/2 days. Arm was sore for 3 days. Then, the diarrhea slowed down, recurs about once a day, but have continued having regular bouts of nausea, especially after eating or when doing something more physically active (skiing, snowshoeing, walking the dogs, swimming). And last night, 10 days after receiving the vaccine, a slightly sore, itchy hive the size of a 1/2 dollar appeared at the injection site and slight soreness returned. No temperature during any of it so far.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/31/2020,11.0,OTH,none,none,Some urticaria,"Was a toddler, penicillin was the medicine. Haven't had it since.",Penicillin,"['Diarrhoea', 'Injection site pain', 'Injection site pruritus', 'Injection site urticaria', 'Nausea', 'Pain in extremity']",1,MODERNA,SYR 931830,AL,48.0,F,RIGHT BICEP RED/ITCHY STARTED ON 1/5/21. INJECTION GIVEN ON 1/4/21. PT STATED FELT LIKE FIRE ANTS WERE BITING HER ARM,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,"AZELASTIN 137MCG, VITAMIN D2, LOSARTAN-HCTZ, METFORMIN, PREVACID AND XYZAL",NONE,"HTN, DIABETES, GERD, VITAMIN D DEF., VITAMIN B12 DEF.",,"BENAZEPRIL, LEVAQUIN, LODINE, NUBAIN, PENICILLINS","['Feeling abnormal', 'Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 931831,MD,36.0,F,"Mild fatigue and body aches x 1 day, fever started up to 103 and then full body rash. More severe symptoms started 1/7-1/8, worsened 1/9. Had close contact with two children and husband, but none have any symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,"None, but started taking Bactrim the day after vaccination",Abscess,None,,None,"['Fatigue', 'Influenza A virus test negative', 'Influenza B virus test', 'Pain', 'Pyrexia', 'Rash', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 931832,FL,63.0,F,"Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taking about 15 seconds to complete injection. Injection was painful. Within 1 hour I could not raise my arm more than 30 degrees without severe pain. Diminished ROM and pain at night is ongoing. Within 4 hours, I had a low grade fever with chills, headache and myalgia that persisted for 12 hours then respoved. I am awaiting an appointment with my primary care physician and will know then if more treatment will be recommended. Incident Report filed at the hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/19/2020,0.0,PVT,Multivitamin,None,History of mitral valve prolapse Low and mid back strain Left meniscal tear,,None,"['Chills', 'Headache', 'Injection site pain', 'Mobility decreased', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,UN 931833,GA,43.0,F,"Patient received Moderna vaccine 1/6/21 at 12:00 pm. At approximately 5:00 pm, patient stated her left arm was hurting, tender and hot to the touch. at 11:00 pm, patient began chilling with body aches. Pt felt dehydrated and very thirsty. No fever. On 1/7/21, patient still had body aches and slept most of the day. Pt took Tylenol throughout day. On 1/8/21, chills and body aches improving, but patient had no appetite and arm still very sore and uncomfortable. On 1/9/21, patient feeling much better. Body aches and chills gone, only symptom now is arm still tender at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,,Positive Covid diagnosis 11/16/21 (tested positive x 3 weeks),,,"shellfish, anaphylactic, epipen necessary","['Chills', 'Decreased appetite', 'Dehydration', 'Injection site pain', 'Limb discomfort', 'Pain', 'Pain in extremity', 'Pain of skin', 'Skin warm', 'Thirst']",1,MODERNA, 931835,CO,36.0,F,"Developed acute onset eyelid swelling, lip swelling, dyspnea with wheezing and hive like swelling at vaccine site. I self administered 8 puffs of albuterol (my prescription) and took 50 mg of oral Benadryl with improvement in wheezing and swelling at injection site. I continue with some mild unilateral right upper eyelid swelling but much improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,,,"Asthma, migraines",,Cephalosporins,"['Dyspnoea', 'Injection site swelling', 'Swelling of eyelid', 'Urticaria', 'Wheezing']",2,PFIZER\BIONTECH,IM 931836,CT,32.0,F,"Arm is swollen, red, itchy. Lymph nodes under arm are swollen. Symptoms did not show until a week after injection. Also mildly nauseous with headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,Pristiq 50mg,,,,Shellfish,"['Erythema', 'Headache', 'Lymphadenopathy', 'Nausea', 'Peripheral swelling', 'Pruritus']",1,MODERNA,IM 931837,TX,56.0,M,"Flu-like symptoms (muscle ache, multi-joint pain) but no fever or congestion; excessive fatigue and sleepiness from about 16-48 hrs after receiving 2nd dose. Resolved after 48 hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"Fluticasone, azelastine, montelukast, cetirizine",,Asthma,,,"['Arthralgia', 'Fatigue', 'Influenza like illness', 'Myalgia', 'Somnolence']",UNK,PFIZER\BIONTECH, 931838,OR,42.0,F,"headache, fatigue, episodes of vertigo beginning on day 3 following vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/09/2021,3.0,PVT,none,none,none,,none,"['Fatigue', 'Headache', 'Vertigo']",1,MODERNA,IM 931840,MI,47.0,F,She initially developed and numbness of her face (both sides). This started in about 15 - 30 minutes after the vaccine and lasted about 2 hours. She had no facial muscle issues. She then developed intense vertigo and nausea. I question possible vestibular neuritis. This lasted about 5 days and was more severe the first 3-4 days. At day 7 she was almost back to normal. She also had a frontal tension style headache,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,WRK,"Sular 8.5 mg qd, Gianvi 1 qd, vit D3 5000 U/day, Valtrex 500 mg/day",None,"environmental allergies, history of complex regional pain syndrome, musculoskeletal pain secondary to prior injuries, Raynaud's disease, recurrent cold sores, vitamin D deficiency-treated, history of positive ANA but no history of autoimmune condition",,"Ultram-hives, Norco-hives","['Headache', 'Hypoaesthesia', 'Nausea', 'Vertigo']",1,PFIZER\BIONTECH,IM 931841,WA,55.0,F,My arm became itchy and hive like lumps. The arm is warm to the touch and the redness is spreading. This happened 5 days post injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,UNK,Vitamin C and D,None,Elevated Cholesterol,,NKA,"['Erythema', 'Mass', 'Pruritus', 'Skin warm']",1,MODERNA,SYR 931842,CA,52.0,F,"Tongue became swollen and itchy, throat was scratchy and felt constricted. High blood pressure was high, dizziness and ringing in the ears",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,High blood pressure,,Penicillin,"['Dizziness', 'Hypertension', 'Swollen tongue', 'Throat irritation', 'Throat tightness', 'Tinnitus', 'Tongue pruritus', 'X-ray']",1,PFIZER\BIONTECH,IM 931843,IL,23.0,F,"Injection site soreness started about 3 hours after administration Chest pain and headache started about 7 hours after administration, went away after 4-5 hours Severe nausea started about 14 hours after administration and lasted for 4 hours Body aches and chills started about 14 hours after administration, lasted for greater than 12 hours, on and off Took ibuprofen and tylenol alternatingly, started feeling relief of some symptoms about 20 hours after administration",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Birth control -Viorele Vitamin D,,,,"Rash, fever, lymphadenopathy to Sulfa Drugs","['Chills', 'Headache', 'Injection site pain', 'Nausea', 'Non-cardiac chest pain', 'Pain']",2,PFIZER\BIONTECH,IM 931844,PA,45.0,F,Hives 14 days post injections,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/31/2020,13.0,PVT,"Methimisole, buspar , multi vitamin",None,Graves? disease,,Latex,['Urticaria'],1,PFIZER\BIONTECH,SYR 931845,TX,26.0,F,"On 01/07/2021 I woke up at 0300am with chills, headache, body aches, joint pain, fever of 101.2 and swollen left axillary lymph nodes. I took Tylenol and Benadryl and it relieved the fever/headache/body aches/joint pain, however the lymph nodes in my left axillary remained swollen. I continue to take Tylenol for the fever/body aches/pains without relief for the swollen and painful axillary lymph nodes. Warm compresses do help to relieve the pain temporarily but they remain painfully swollen. On 01/08/21 I called my doctors office to ask if it was normal to experience such painfully swollen axillary lymph nodes to which they stated ?we don?t know, it is too soon for us to tell what?s normal and what isn?t normal right now.? They did not offer any suggestions to relieve the pain or swelling. The morning of 01/09/2021 , I called Employee Health at my hospital (my place of work and also where I received the vaccine) and they also stated they didn?t know if this was a normal reaction due to the newness of the vaccine. A couple hours later, employee health emailed me a link to the VAERS reporting website and asked me to file a report.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/06/2021,01/07/2021,1.0,PVT,Vraylar 1.5mg daily Trintillix 40mg daily Vyvanse 60mg daily Vitamin C 1000mg daily,,Major depressive disorder In 2015 I was diagnosed with chronic Epstein Barr Virus Disease because I tested positive for that virus for 3 consecutive 3 month periods. However I finally tested negative for 3 consecutive 3 month periods in 2017 and have not tested positive since. Last negative test was in 2018 I believe.,,Pineapple,"['Arthralgia', 'Chills', 'Headache', 'Lymph node pain', 'Lymphadenopathy', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931846,KY,25.0,F,Injection site reaction with increasing redness and swelling with a large indurated area at the center that developed overnight along with a fever that was treated with tylenol. The hive persisted for 4 days after which topical benadryl was applied and symptoms began to desist. The area is no longer red or swollen but is still hard to the touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,None.,None.,None.,,None.,"['Injection site erythema', 'Injection site induration', 'Injection site reaction', 'Injection site swelling', 'Pyrexia', 'Urticaria']",1,PFIZER\BIONTECH,IM 931847,NY,49.0,F,"01/08/21: Sudden onset of extreme body/muscular pain, such that moving was difficult. Extreme chills, headache. Needed pain medicine to alleviate pain. Fatigue. 01/09:21: AM: Less body pain , but feeling of heaviness in head; weak. PM: Had onset of lower GI symptoms: painful abdominal/cramps, stomach pain, nausea. No vomiting, but had several episodes of diarrhea. Feeling like passing out but never did. Loss of appetite. Slowly resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Abdominal pain', 'Abdominal pain upper', 'Asthenia', 'Chills', 'Decreased appetite', 'Diarrhoea', 'Fatigue', 'Head discomfort', 'Headache', 'Movement disorder', 'Myalgia', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 931848,TN,25.0,F,Extreme urticaria and bubbles under the skin,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/06/2021,3.0,PUB,,,,,,"['Skin disorder', 'Urticaria']",1,MODERNA,IM 931849,TX,57.0,U,EVS employee stated she had itching at the bandaid site. on arm where vaccine was given. When bandaid removed you could see a redness around the site of bandaid. She only complained of itchiing until bandaid was removed. Later that day she c/o of headache and took tylenol on her own. She told me next day she had a headache most of the night and body aches. All education material was given to her in spanish and she stated she read them and understood. I instructed her to go to ED or call 911 if itching and redness became worse orwas having trouble breathing or swallowing. She denied other sx at time of observation. It was over 30 minutes. She returned to work on floor.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,UNK,,,,,,"['Headache', 'Injection site erythema', 'Injection site pruritus', 'Pain']",UNK,MODERNA,IM 931850,NC,64.0,F,"Fever99.7, headache, back pain, hip pain, chills , fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"Effexor, gabapenton",None,None,,None . Morphine causes itching,"['Arthralgia', 'Back pain', 'Chills', 'Fatigue', 'Headache', 'Pyrexia']",1,MODERNA, 931851,AK,32.0,F,I am currently breastfeeding my 5-month-old son. I received my first vaccine on 12/28/2020 and directly breastfed within 4 hours of receiving the vaccine. Two days after my vaccine my son was at daycare and had two large diarrhea blowouts and two large emeses followed by a 1-minute episode where he was limp with entire body cyanosis and in-and-out of consciousness. He also had a maculopapular rash on his torso. EMS was called. He was observed in the emergency department for a few hours then recovered well without intervention and did not require hospitalization. EKG was normal. He has continued to be well and back to baseline since the event.,Not Reported,,Yes,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,OTH,"Levothyroxine, prenatal vitamin, vitamin D",N/a,Hashimoto?s thyroiditis/hypothyroidism,,N/a,['Maternal exposure during breast feeding'],1,PFIZER\BIONTECH,IM 931852,AZ,35.0,F,"Rash, on lower back, left arm, abdomen and left leg",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/31/2020,3.0,PVT,None,None,"Fibromyalgia, inappropriate sinus tachycardia,",,"Demerol, motrin, penicillin, seasonal",['Rash'],1,MODERNA,SYR 931857,NC,51.0,F,Diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,"Prozac, trazodone, meloxicam, zyrtec",Arthritis Mild asthma,Mild asthma Depression/anxiety,,"Sulfa, shellfish, nickel, seasonal",['Diarrhoea'],1,PFIZER\BIONTECH,IM 931858,MA,59.0,F,"Moderna COVID-19 Vaccine EUA Chills, Rigors , Severe Headache , Extreme fatigue Began at 7:00pm 12/31/2020, , Chills , Rigors resolved at midnight , Headaches and fatigue continued till 1/2/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Calcium , vitamin D , Vitamin C",None,None,,No known allergies,"['Chills', 'Fatigue', 'Headache']",1,MODERNA,IM 931859,AK,53.0,F,"Customer rec'd COVID-19 vaccine at 1208pm and transferred to post vaccine observation. Customer noted to be frequently rubbing her eyes, initially denies feeling any symptoms. Symptoms of itching eyes persistent followed by customer clearing throat repeatedly. Continues to deny symptoms related to vaccine. States that she has anxiety. Customer noted to be hypotensive at 1226 98/68. Refuses epinepherine, transport to ED for monitoring. Customer accepts Benadryl 50mg PO @ 1227. O2 sat ~94-95%, pulse 79-84. Customer monitored at site, escort and significant other, at chairside. Customer persistent with her request to leave throughout observation, states she is fine. Customer and escort counseled to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED. Customer and escort in agreement with plan. Customer does not have resolution with dry throat symptoms but does not wish to remain in observation any longer. Vitals at 1307 consistent with baseline as documented previously in chart. Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer denies questions/concerns. Escort verbalizes understanding of instruction and agrees to remain with customer for the next 24 hours. Customer released from site at 1315, ambulating independently with steady gait, no obvious s/sx of distress",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,WRK,Bentyl 20mg PO Hydroxyzine 10mg PO Clonazepam 0.5mg PO Carafate 1gm PO Lexapro 20mg PO Lidocaine 2% topical gel Voltaren 1% topical gel Omeprazole 20mg PO Tylenol 325mg PO Trazodone 50mg PO Vitamin D3 1000 IU PO Colace 100mg PO,"Pharyngitis 2/2 COVID-19, GERD, chronic anxiety","Anxiety, Vit D deficient, neuropathy",,"sulfamethoxazole-trimethoprim, codeine","['Anxiety', 'Dry throat', 'Eye pruritus', 'Hypotension', 'Throat irritation']",1,PFIZER\BIONTECH,IM 931860,VA,44.0,F,Shortly after vaccination I developed tachycardia which continues to persist. Also in the last three days I have started having violent shaking.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/24/2020,3.0,PVT,None,None,History of dermatomyositis though not receiving any treatment,,None,"['Electrocardiogram', 'Laboratory test', 'Tachycardia', 'Tremor']",1,PFIZER\BIONTECH,IM 931861,CA,26.0,F,Since taking the shot I have not had my period. I missed my period in December and I am not sure if I am getting it on January.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,Acetaminophen,,,,,"['Menstruation delayed', 'Pregnancy test negative']",UNK,PFIZER\BIONTECH,IM 931862,IL,53.0,F,at 12 hours post vaccine I had Headeaches and Body Aches for the next 20 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,none,none,none,,no,"['Headache', 'Pain']",UNK,PFIZER\BIONTECH,IM 931863,DC,36.0,F,"When I received the shot the left arm itchy immediately yet the itching faded. The next early morning I had pain in the left arm as expected. I had a throbbing head ache and nausea through the morning I woke up at 5am and nausea was better by 8. I felt sore and tired that day. January 1st there were no more symptoms. On January 8th I noticed hives around the injection spot and itching I had not noticed the itching since the day of the shot. I stopped wearing the band aid the morning after the shot, mentioning this in case the bandage could have caused hives.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PHM,Claritin-D,,"Eczema, food allergies, seasonal allergies,",,"Latex, peanut, egg, milk","['Fatigue', 'Headache', 'Immediate post-injection reaction', 'Injection site pruritus', 'Injection site urticaria', 'Nausea', 'Pain', 'Pain in extremity']",1,MODERNA,SYR 931864,IL,46.0,F,"Chills, Headache, Nausea, and Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,none,no,no,,none,"['Chills', 'Headache', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 931865,CO,40.0,F,"Headache (4/10) and body aches (5/10) pain respectively began at about 18 hours after injection. Body and head aches, particularly joints and back, continue and have worsened at 30 hours out. Mild-mod soreness at injection site (4/10)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Levothyroxine 25 mcg daily,,Insomnia Depression,,Penicillin,"['Arthralgia', 'Back pain', 'Headache', 'Injection site pain', 'Pain']",2,PFIZER\BIONTECH,IM 931866,TN,25.0,F,Arm is lumpy under skin surface and itchy at injection one week after vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,SCH,,None,None,,,"['Injection site mass', 'Injection site pruritus']",1,MODERNA,IM 931867,NY,37.0,F,"Approximately 20 minutes after receiving Moderna dose # 1, as patient was being observed for 30 minutes due to hx of pen allergy- patient began to experience facial numbness to right cheek area, crossing over mouth towards the left side of her face. Also noticed slight numbness of fingertips to right hand. Patient attributed this to her mask being on too tight and receiving the vaccine in right arm and was discharged from clinic without stating the above. As patient began to drive 50 minutes to home, she called her husband and stated she felt numb inside her right gum and cheek- he advised her to return to clinic. Patient presented to me as screener for COVID testing line- stating she was just here but didn't feel right- I escorted her inside- steady gait, no SOB, dyspnea, speaking in full sentences, upon reaching discharge area, VS 98.3- HR 61 reg- resps 18 unlabored, b/p 122/72 pulse ox r/a 100%. Pt asked to remove mask, no circumoral pallor or swelling noted, uvula midline, right cheek area is reddened, no rash or hives noted, pt described as ""hot"". MD contacted via phone- spoke with patient, who agreed to stay for observation, no further intervention at this time. Drs also consulted- patient observed for 40 minutes, was discharged to follow up with PMD - no resp distress, lungs clear upon auscultation by RN, repeat VS- 98.7 hr 59 reg- resps 18, b/p 116/73 O2 sat 98% r/a-",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PUB,none known,denied,dnied,,hx penicillin allergy as a child,"['Erythema', 'Feeling abnormal', 'Feeling hot', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Injection site pain']",1,MODERNA,IM 931868,AK,72.0,F,"Had COVID vaccine and was being monitored. At 10:10am, she became nauseous and started vomiting. She felt short of breath and difficulty breathing. Felt dizzy/lightheaded. History of anaphylaxis and allergies. History of COPD/asthma. Due to vomiting, short of breath and dizziness, given epipen at 10:15am and called 911. Continued to monitor and developed worsening shortness of breath. Second epipen given at 10:25am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,OTH,"albuterol 2.5 mg/3 mL (0.083%) inhalation solution, 2.5 mg= 3 mL, INH, q6hr, PRN, 3 refills albuterol 90 mcg/inh inhalation aerosol, 2 puff(s), INH, q4hr, PRN, 11 refills alendronate 70 mg oral tablet, 70 mg= 1 tab(s), Oral, qWeek, 4 refi",hypokalemia asthma exacerbation,"Problem List/Past Medical History Ongoing Anemia Aortic valve regurgitation Asthma Benign essential hypertension Cerebrovascular disease Chronic eczema Dysphagia Elevated LFTs GERD (gastroesophageal reflux disease) Hypoesthesia of skin Mixed conductive and sensorineural hearing loss of left ear with restricted hearing of right ear Neurogenic dermatitis Osteoporosis Palpitations Personal history of colonic polyps Pulmonary nodules Sensation alteration, late effect of cerebrovascular disease Sensorineural hearing loss of right ear with restricted hearing of left ear Status post aortic valve replacement with bioprosthetic valve Urinary tract infection Vertigo Historical Asymmetrical hearing loss Bleeding from the nose Cerumen impaction Chronic Rhinitis Chronic sinusitis Dizziness, nonspecific ESBL (extended spectrum beta-lactamase) producing bacteria infection Pyelonephritis Reflux pharyngitis Sensorineural hearing loss Solitary Pulmonary Nodule, LLL Tinnitus of left ear",,"fish, shellfish","['Dizziness', 'Dyspnoea', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 931869,HI,36.0,F,"Probably with in 30 sec of the vaccine being administered I started to not feel well. Felt like it spread through my body, I felt a weird feeling in my chest, throat, my legs felt weak, I was light headed and my heart started to beat hard and fast. It then started to subside over several minutes. The nurse kept me for 30 minutes and then I felt ok to walk out. I had a bit of a headache and didn?t feel right the rest of the night.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,Postural orthostatic tachycardia syndrome (POTS),,Percocet (vertigo),"['Dizziness', 'Feeling abnormal', 'Headache', 'Malaise', 'Muscular weakness', 'Palpitations']",1,PFIZER\BIONTECH,IM 931870,OR,28.0,F,"She had red inflammation following vaccine which took 6 days to clear. Day 7 she had the red inflammation return and quickly enlarge from 4.5c, to to 9.5cm x 7.5 in 8 yhours",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/09/2021,7.0,WRK,"Wellbutrin, apri, topomax",none,none,,Nickle,['Inflammation'],1,MODERNA,IM 931871,IN,34.0,F,"Immediately: Blurred vision, dizzy, tachycardia, sweat, felt I couldn?t breathe, shaking, felt hot, redness of chest ? tx: Oj, cold compress, removed mask, uncrossed legs, waited, deep breaths Day 2: headache, flu like symptoms, fatigue, sore arm,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Nuvaring,No,No,,No,"['Dizziness', 'Dyspnoea', 'Erythema', 'Fatigue', 'Feeling hot', 'Headache', 'Hyperhidrosis', 'Influenza like illness', 'Pain in extremity', 'Tachycardia', 'Tremor', 'Vision blurred']",1,MODERNA,SYR 931872,CA,66.0,M,"Fever, body ache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,MIL,Tylenol,None,None,,"Shell fish, strawberries","['Pain', 'Pyrexia']",1,MODERNA,SYR 931873,CT,64.0,F,"About 3 minutes after receiving exam went to sit down to wait for 15 minutes. A flush came over my body and I felt myself becoming tachycardic. I spoke to the nurse who hooked me up to bp machine. O2 sat was fine at 98. BP was 158/110, pulse rate was 157. Normal values for me are bp 120/70, pulse 80. BP started to go down and several minutes later another flush happened and bp and pulse rate went back up. Dropped again then third flush with increased bp and pulse happened. After this vitals went back to normal and didn't happen again. I subsequently developed a pounding headache which lasted until the next morning. Arm was sore as expected. BP that night was normal and the next morning normal. No further adverse effects noted other than fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Stopped Plaquenil 100 mg daily two days prior to vaccination Take magnesium 100 mg qpm Take a probiotic qpm,None,Fibromyalgia,,Cephalaxin - hives IVP contrast - hives,"['Blood pressure increased', 'Fatigue', 'Flushing', 'Headache', 'Heart rate increased', 'Pain in extremity', 'Tachycardia']",1,MODERNA,IM 931874,MD,58.0,F,"103 fever, chills, arm pain at injection site, headache. Fever lasting 1 day, arm pain lasting 3-4 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Not taken at the time of vaccination.,Diabetes Type 2,Diabetes Type 2,,"Sulfa, Ampicillin","['Chills', 'Headache', 'Injection site pain', 'Pyrexia']",UNK,MODERNA,IM 931875,GA,38.0,M,"Received Moderna vaccine 1/6/21 at 9:10 am. Felt fine until approximately 4:00 pm when he noticed his left arm was very sore. At approximately 9:30 pm, the patient became cold with shivering. Temp fluctuated during night between 99 - 103.8. During the night, he experienced nausea and vomiting, dizziness, body aches, and a weird taste in mouth. On 1/7/21, patient still complained of fever, headache, nausea, and the new symptom of diarrhea. His neck was now very sore, with pain moving it right or left. On 1/8/21, slight improvement of symptoms. On 1/8/21 at 7:00 pm, he noticed a very itchy, red raised rash on torso, arms and legs. He called his physician and was called in a prescription for steroids. The pharmacy was closed and he picked the steroids up on the morning of 1/9/21. He took the steroids on 1/9/21 and has noticed major improvements. Rash still present, but not itching. Temp currently 99.1, but all other symptoms improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,,Positive Covid diagnosis 12/19/2020,"Pre-diabetic, obese (345 pounds)",,no allergies,"['Body temperature fluctuation', 'Chills', 'Diarrhoea', 'Dizziness', 'Dysgeusia', 'Feeling cold', 'Headache', 'Nausea', 'Neck pain', 'Pain', 'Pain in extremity', 'Pyrexia', 'Rash', 'Rash erythematous', 'Rash papular', 'Rash pruritic', 'Vomiting']",1,MODERNA,IM 931876,MS,60.0,F,"Dizziness immmediately post vaccine and continued x 31 hours, malaise,, lower than normal Blood pressure x 31 hours post vaccine, Rash on upper back 6-10 hours post Vaccine Benadryl and increased fluid. Antivert for dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PUB,"Triamterene/HCTZ, Wellbutrin, Losartan, Topamax",None,"Hypertension, Menieres Disease, Migraine Headaches",,"Penicillin, Cipro","['Dizziness', 'Immediate post-injection reaction', 'Malaise', 'Rash']",1,MODERNA,IM 931877,CA,49.0,F,Heat/flushing from injection site to neck to face to upper body x 20 minutes; sweating,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Coreg ASA Elderberry Gummies Vit D Vit C,Cardiomyopathy Neuropathy,Cardiomyopathy,,"PCN, Sulfa, Morphine, Shrimp","['Feeling hot', 'Flushing', 'Hyperhidrosis', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 931878,CO,52.0,F,Moderna COVID-19 Vaccine EUA Soreness and warm at shot site but not hard. Extreme fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,None,None. Covid positive w/ mild symptoms ( loss of taste/smell) 11/20/20.,None.,,Sulfa meds One experience of tongue swelling after eating scallops.,"['Fatigue', 'Injection site pain', 'Injection site warmth']",1,MODERNA,SYR 931879,OK,31.0,F,lymphadenopathy In left armpit,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/09/2021,5.0,PUB,Lexapro Cyclobenzaprine Esomeprazole,,,,,['Lymphadenopathy'],1,MODERNA,IM 931880,IN,57.0,F,"HEADACHE, SORE THROAT, BODY ACHES, RUNNY NOSE, DIARHEA",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,paroxetine 30 mg,none,none,,none,"['Diarrhoea', 'Headache', 'Oropharyngeal pain', 'Pain', 'Rhinorrhoea']",1,MODERNA,IM 931881,AK,56.0,F,"Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, left arm weakness/numbness, skin itching. BP checked and was 190/110, then 180/110. Hx HTN and BP meds taken today. Hx of allergies -- took loratadine and hydroxyzine this AM. Due to the dizziness and skin itching, feeling unwell/woozy with history of anaphylaxis, given epipen and called 911. EMS arrived and taken to ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,OTH,"albuterol 90 mcg/inh inhalation aerosol, 2 puff(s), INH, QID, PRN Astelin 137 mcg/inh nasal spray, 2 spray(s), Nasal-Both Nostrils, BID, 2 refills BLM Oral-Topical Suspension, 10 mL, Oral, q4hr, PRN budesonide 32 mcg/inh nasal spray, 2 s",cough,"Problem List/Past Medical History Ongoing Anxiety Atrophic vaginitis Atypical chest pain Costochondritis, acute Cystocele, unspecified Family history of colon cancer Hypertension Hyperthyroidism Intermittent Right Bundle Branch Block Nasal deviation Nasal obstruction Nasal septal perforation Neck pain Spondyloarthropathy Subclinical hyperthyroidism UTI (urinary tract infection) Historical Acquired deformity of nose Chronic sinusitis Chronic tonsillitis Iritis Laryngopharyngeal reflux",,"oranges, septra, tomatoes","['Chest pain', 'Dizziness', 'Hypoaesthesia', 'Malaise', 'Muscular weakness', 'Nausea', 'Pruritus']",1,PFIZER\BIONTECH,IM 931882,OH,26.0,F,"swelling at injection site, redness at injection site, muscle pain at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Lexapro, Seroquel, Topamax Maxalt, Tylonel",,"Bilateral PE, migraines, anxiety, depression",,"chocolate, latex, hay fever, oak pollen, Flonase, Eloquis","['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 931883,CA,46.0,F,3:40 pm - at 10 minutes after receiving vaccine pt reports feeling warm and dizzy. 3:49 pm pt evaluated by EMS BP 165/99 P 67 O2sat 100 % 4:14 pm EMS transported pt to the hospital,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PUB,"Atenolol, Aspirin",,HTN,,,"['Dizziness', 'Feeling hot']",1,MODERNA,IM 931884,MA,56.0,F,"Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later Tylenol taken Next day painful injection site, body aches chills fatigue Tylenol Advil taken with some relief",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,"Aspirin, Zoloft, norvasc, Crestor, centrum silver, caltrate d, elderberry",,,,"Raglan, Percocet, Wellbutrin","['Chills', 'Dizziness', 'Dysgeusia', 'Fatigue', 'Flushing', 'Injection site pain', 'Nausea', 'Pain', 'Palpitations']",2,PFIZER\BIONTECH,IM 931885,UT,61.0,F,"Injection site became red about an inch around,it, warm to the touch and itchy about a week after the injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,Prozac Wellbutrin Xanax OTC vitamin supplements,None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,SYR 931886,CA,28.0,F,Arm soreness starting the next day after injection and lasting for 4 days Fatigue starting about 6 hours after injection and lasting for 2 days Brain fog starting about 6 hours after injection and lasting for 2 days Mild headache starting about 6 hours after injection and lasting for about 4 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"Loratadine, multivitamins, probiotics",,,,None,"['Fatigue', 'Feeling abnormal', 'Headache', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 931887,IN,80.0,F,Skin rash all over body,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Levothyroxin, vitamin D2",Going in for right shoulder replacement in a couple weeks.,none,,None,['Rash'],UNK,PFIZER\BIONTECH,IM 931888,UT,51.0,F,"Fever 24 hours later. Red, swollen, hot at the injection site. Red blotchy skin spread to 4""x6"". Painful still, after three days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,"Multi-vitamin, Vitamin D, Vitamin B12, Biotin",COVID 19 one month prior,Morbid Obesity,,None,"['Injection site erythema', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Pyrexia', 'Rash', 'Rash macular']",1,MODERNA,IM 931889,AK,54.0,F,"Had COVID vaccine #1. Developed a numbness and tingling sensation in hands and legs at 10:45a. Denies any rash, mouth/throat swelling, difficulty breathing, itching, wheezing, or racing heart. Check vitals: O2 98% HR 72 BP 118/80 Monitored until 11:20. Rechecked periodically and her symptoms resolved. Advised that if symptoms return then go to ER. Discharged home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,OTH,"Artificial Tears preserved ophthalmic solution See Instructions Chondroitin-Glucosamine 1 cap(s), Oral, Daily Fish Oil , Oral Multivitamins and Minerals Premarin 0.625 mg oral tablet 0.625 mg = 1 tab(s), Oral, Daily Premarin 0.625 mg/g vag",,"Problem list: All Problems Adhesive capsulitis of right shoulder / Confirmed Atrophic vaginitis / Confirmed Neurogenic bladder / Confirmed Constipation, chronic / Confirmed Clicking tinnitus / Confirmed Dyspnea / Confirmed Myofascial pain syndrome / Confirmed Hx estrogen therapy / Confirmed History of migraine with aura / Confirmed Nephrolithiasis / Confirmed Low back strain / Confirmed Microscopic hematuria / Confirmed Mitral regurgitation due to cusp prolapse / Confirmed PVD (posterior vitreous detachment) / Confirmed Segmental and somatic dysfunction of lumbar region / Confirmed Segmental and somatic dysfunction of pelvic region / Confirmed Segmental and somatic dysfunction of thoracic region / Confirmed Muscle spasm of back / Confirmed Dysphonia, spasmodic / Confirmed 3/2012, per ENT",,flexeril inapsine,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 931890,KS,30.0,M,"Hives, Difficulty Breathing. Lasted about 3 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,PUB,None,,,,"Motrin, Mold","['Dyspnoea', 'Urticaria']",1,MODERNA,SYR 931891,CO,30.0,M,Two hours after injection my pinky toe and digit next to it on right foot went numb for two hours total. Felt slight tingle in both feet that night. Had a fever that night and have been congested since getting the vaccine. Had a covid swab test on 1/7 and was negative.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,None,None,None,,None,"['Hypoaesthesia', 'Paraesthesia', 'Pyrexia', 'Respiratory tract congestion', 'SARS-CoV-2 test negative']",1,MODERNA,IM 931892,CA,31.0,F,"On day 1 I felt slight headache arm pain when trying to move. Day 2 I had severe arm pain, headache, severe muscle aches, nausea and vomiting with severe chills. I felt so sick and so cold and severe pain that I went to bed for 4 hours. I can?t lay on my left arm let alone move it. My body just has severe muscle aches slight fever. This was worse then having covid-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Feeling cold', 'Headache', 'Injected limb mobility decreased', 'Malaise', 'Myalgia', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,MODERNA, 931893,AK,66.0,M,"No immediate post vaccine symptoms other than slight clear rhinorrhea and mild sneezing for a few hours. By evening about 12 hours post vaccine felt fatigue and some increase in mild baseline myalgias. During night sleep significantly disrupted by generalized myalgias, along with some strange transient paresthesia. Such that at about 4:30 AM I texted my 3 workplaces that I did not expect to go to work that day. Went back to bed, woke up around 9:30 AM 1/8/2021 and nearly all myalgias resolved, still fatigued but better. Paresthesia's were transient and resolved. Went to work after all. Today, Saturday 1/9/21 woke up and all symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"levothyroxine 137 mcg QD, HCTZ 12.5 mg QD, losartan 100 mg QD, dutasteride 0.5 mg QD, mirtazipine 15 mg PO Note was on rosuvastatin 10 mg po QD and stopped 1/2/2021",None,"HTN, BPH, hyperlipidema, hypothyroidism, obesity, OSA, situation anxiety (onset with pandemic :-) Feb 2020)",,none although statins may contribute to myalgias for me,"['Fatigue', 'Impaired work ability', 'Myalgia', 'Paraesthesia', 'Rhinorrhoea', 'Sneezing']",2,PFIZER\BIONTECH,IM 931894,CA,54.0,F,"Myalgia, Fever, fatigue, Chills, HA, Sinus congestion, Difficulty breathing, Dry cough improving",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Chills', 'Cough', 'Dyspnoea', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia', 'Sinus congestion']",2,PFIZER\BIONTECH,IM 931895,SD,44.0,F,"Approx 16 hours after 2nd vaccination on 1/7/21, I felt nauseous. Then fever, body aches, joint pain, severe headache. Second day I still have severe headache and nauseousness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Synthroid,None,None,,Penicillin,"['Arthralgia', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 931896,VA,23.0,F,"Fever, chills, body aches, joint pain, lightheaded, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,UNK,,,,,,"['Arthralgia', 'Chills', 'Dizziness', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931897,MI,30.0,M,"Headache, myalgias, chills, 99.8 deg F elevated temp, fatigue. Tylenol was used. Resolved after 48hrs. Had to miss 1 day of work",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,Penicillin,"['Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Myalgia']",UNK,MODERNA, 931898,NY,47.0,F,"About 1 hour after injection, I started getting very itchy so I took a benadryl. This morning I woke you with body pain everywhere, especially to arm of injection. Running fever of 101.4 and higher, all over body rash that is extremely itchy. Very fatigued feeling.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"Famotidine, vitamin d, vitamin B 12,",None,"GERD,",,"Penicillin, bee stings","['Fatigue', 'Injection site pain', 'Pain', 'Pruritus', 'Pyrexia', 'Rash']",2,PFIZER\BIONTECH,IM 931899,TX,41.0,F,"Red, swelling. 12/24 egg sized lump at injection site, pain, hot, itchy for 3 days. Swelling subsided, but raised, red, itchy rash 4 inches around appeared on 12/28, lasted until 1/4, pink and bruised now.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,"Lamictal, vyvanse, seroquel, singulair",None,None,,"Penicillin and cephalosporins (bleeding), adhesives, cedar","['Injection site bruising', 'Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",1,MODERNA,SYR 931900,NJ,40.0,F,"1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Claritin, Multi-vitamin Alive for women",,,,,"['Chest X-ray normal', 'Chest discomfort', 'Chills', 'Headache', 'Joint range of motion decreased', 'Laboratory test normal', 'Nausea', 'Pain in extremity', 'Pain in jaw', 'Pyrexia', 'Sensitive skin', 'Troponin normal']",1,PFIZER\BIONTECH,SYR 931901,GA,33.0,F,"Patient received vaccine 01/07/2021 at 1:50 pm. Patient was sitting in waiting area for 15 minutes post vaccination. At 2:05, patient began feeling light-headed and dizzy. Patient was clammy and felt she might faint. Patient was moved out of waiting area and reclined in exam chair. Patient felt much better after ten minutes. Vitals were stable. Patient had some gatorade and was carrying on normal conversation with nurses. Patient observed x 30 additional minutes before leaving office.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,,denies,,,denies,"['Cold sweat', 'Dizziness']",1,MODERNA,IM 931902,FL,39.0,F,"Initial muscle soreness hours post injection 3 days later soreness much milder but vaccine site firm raised swollen red and warm to touch (about the size of an egg) Pain under the axila same arm as injection (lymph nodes) Sore throat, productive cough and congestion began 1 week after injection. Currently 11 days post injection and site is still red swollen warm and firm. Lymph nodes still inflamed in the axila on same arm as injection. Still having congestion and cough.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,"Zyrtec, Flonase, probiotic, multi vitamin",None,None,,None,"['Injection site erythema', 'Lymph node pain', 'Lymphadenopathy', 'Myalgia', 'Oropharyngeal pain', 'Productive cough', 'Respiratory tract congestion', 'Vaccination site induration', 'Vaccination site swelling', 'Vaccination site warmth']",1,MODERNA,IM 931903,VA,24.0,F,Fever Diarrhea Nausea Aches and pains Fatigue Vomiting Confusion,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,,,FMF,,,"['Confusional state', 'Diarrhoea', 'Fatigue', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",1,MODERNA, 931905,IL,58.0,F,"Approx 8-10 min after rec. shot, started to feel lip begin to swell and became difficult to swallow. At 5:34 pm when 15 min wait was done told staff what was happening. Was triaged by NP and MD on standby along w/EMT treated w/50 Benadryl/20 Pepcid/125 Solumedrol IVP. Waited in onsite Immediate Care and was given 1L 0.9 NS bolus. Transferred by ambulance to ER at 6:45 pm after experiencing tingling to chest and dizziness. Tingling changed to warmth in route to ER. Observed in ER and discharged home at 9 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,"MVI, Vit D, Vit C, baby ecotrin, omeprazole, FDGuard, atorvastatin, Wellbutrin, topamax, Tylenol, colace, Flonase, Sudafed PE",None,"High cholesterol, anxiety, depression, osteoporosis",,"PCN (hives), Oxycodone (hives), benzoyl peroxide (hives), sensitive to long acting Sudafed (palpitations)","['Dizziness', 'Dysphagia', 'Electrocardiogram normal', 'Feeling hot', 'Lip swelling', 'Paraesthesia']",UNK,PFIZER\BIONTECH,IM 931906,KS,47.0,F,Redness & swelling remaining on day 9 after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,"Avonex, gabapentin, amitriptyline, ursodiol, fish oil, vitamin B12, Zyrtec",Sinus infection one month prior with 6 negative COVID test results,"Multiple Sclerosis, Primary Biliary Cholangitis",,NKA,"['Erythema', 'Swelling']",1,MODERNA,IM 931907,DE,60.0,F,"Approximately 24 hrs after injectio rash occurred to groin area & lower abdomen. Then appeared in multiple patchy areas. Over next 10 days rash appeared on right of mid sternum, right upper ribs, coccyx area, nap of neck. Rash was small red bumps any extremely pruritic",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,Levothyroxine Trintella. Toprol entresto crestor zetia MVI,None,"HTN cardiomyopathy, resolved.",,Restoril causes hives on back,"['Rash', 'Rash erythematous', 'Rash pruritic']",UNK,PFIZER\BIONTECH,IM 931908,WI,38.0,F,"About 15 minutes after the injection I felt a warm sensation throughout my body and it went away immediately. About 10 minutes after that, my throat started feeling scratchy/itchy/tingling, then my tongue and lips. After about 10 minutes it went away. I felt ok so I left the vaccination area and went back to my department I work in. For several hours the same symptoms came and went in waves, lessening over time. At 8:30pm the same day, I took 25 mg PO Benadryl to feel safe while sleeping. I felt fine the next day and reported it to the pharmacist in the vaccination clinic. I never felt like my airway was compromised.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,OTH,Vitamin D Vitamin C B Complex Zinc,None,CKD (mild) Over production of mast cells,,"Augmentin (angioedema, hives)","['Feeling hot', 'Obstructive airways disorder', 'Oropharyngeal discomfort', 'Paraesthesia oral', 'Pharyngeal paraesthesia', 'Throat irritation']",1,PFIZER\BIONTECH,SYR 931909,PA,34.0,F,"Bone pain all throughout, fevers, headaches, stomach pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,N/a,N/a,N/a,,"Penicillin, all nuts","['Abdominal pain upper', 'Bone pain', 'Headache', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 931910,TX,25.0,F,Chills,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,['Chills'],2,PFIZER\BIONTECH,IM 931911,PA,41.0,F,"Red raised well demarcated area to rigth deltoid, non-tender; extremely itchy. Localized to injection site, 8 days post vaccine. Some mild soreness to right axilla and right anterior cervical area. Rash is continuing to spread across upper arm, began as a half dollar sized, raised welt and is now approx 7 inches long by 4 inches wide, wrapped around arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,PVT,None,None,None,,Penicillin,"['Axillary pain', 'Injection site erythema', 'Injection site pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 931912,FL,31.0,F,"Side effects started 12 hours after 2nd dose of vaccine (lot EL1284). I got chills, body aches, nausea, enlarged and swollen lymph node under left armpit that is warm to the touch and hurts.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,,,Asthma,,"Shellfish allergies, nasal allergies, allergy to mold, cockroaches","['Axillary pain', 'Chills', 'Lymphadenopathy', 'Nausea', 'Pain', 'Skin warm']",1,PFIZER\BIONTECH,SYR 931913,FL,57.0,F,Ringing in ears,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/24/2020,2.0,PVT,"Synthesis, AREDS supplements, fit D",None,Hypothyroid,,"PCN, bee stings",['Tinnitus'],1,PFIZER\BIONTECH,SYR 931914,IA,26.0,M,"Muscle aches, diffuse, duration of 12 hours, improved with ibuprofen. Headache, diffuse, duration of 10 hours, improved with ibuprofen. Chills, duration of 8 hours, improved with ibuprofen. Pain at injection site, duration of 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PHM,None,None,None,,Amoxicillin - hives Cefazolin - hives,"['Chills', 'Headache', 'Injection site pain', 'Myalgia']",1,MODERNA,SYR 931915,IN,23.0,F,"I received my first dose of the Moderna vaccine on Tuesday, January 5th at 9:00 AM. I felt fine immediately following the vaccine but quickly felt worse throughout the day. I developed a fever of 101.4F with medicine, chills, muscle aches, fatigue, and general malaise. I know these are all common symptoms, so I didn't worry too much. However, my fever has persisted. I stayed home from work Wednesday, Thursday, and Friday due to not feeling well and still having a fever. Thursday, I also developed pain in my armpit with movement and palpation. I am guessing that pain in related to swollen lymph nodes. Friday, the pain in my armpit seemed to spread into my arm. Most of my armpit and the upper inside of my bicep is extremely tender to movement and touch. Today, I still have some tenderness in my arm and my fever is still present. Throughout this week, my fever has remained around 100F, even with Tylenol and ibuprofen. I contacted my PCP yesterday about my concern for my persistent fever and arm pain. They believe that because I tested positive for COVID-19 in October 2020, that I am reacting to the first dose of the vaccine as if I am receiving the second dose of the vaccine. They advised me to continue taking ibuprofen and Tylenol. I am worried that if I receive the second dose of the vaccine, I will be sick for longer.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Remicade, multivitamin, melatonin, vitamin D supplement, probiotic",none,Crohn's disease,,Codeine (hives & pharyngeal swelling),"['Axillary pain', 'Chills', 'Fatigue', 'Lymphadenopathy', 'Malaise', 'Myalgia', 'Pain', 'Pain in extremity', 'Pyrexia', 'Tenderness']",2,MODERNA,IM 931916,FL,77.0,M,Slight arm pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,"(1) Clopidogrel 75mg, (1) Telmisartan 20mg, (1) Isosorbide Mononitrate 10mg, (1) Eliquis 2.5mg, (1) Vitamin B-12 1000 mcg, (1) Vitamin D3 2000 iu, and (1) Vitamin Folic Acid 1000 mcg",Heart Decease and Cirrhosis of the Liver,Heart Decease and Cirrhosis of the Liver,,none,['Pain in extremity'],1,MODERNA,IM 931917,TX,64.0,F,"Immediate metallic taste in my mouth, followed by itching of arms neck and throat. About 10 minutes post shot, my tongue felt like it was swelling, that swelling only lasted about 20 seconds. Shortly after that I had an overall feeling of tiredness,lethargic and foggy brain. All of these symptoms lasted about three and a half hours. At about four hours after the shot, I began to have diarrhea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Synthroid, singulair, climara patch, advair",None,Adult onset asthma,Tetanus toxoid,"Tetanus toxoid, succinylcholine, pecans","['Diarrhoea', 'Dysgeusia', 'Fatigue', 'Feeling abnormal', 'Immediate post-injection reaction', 'Lethargy', 'Pruritus', 'Swollen tongue']",1,MODERNA,IM 931918,MI,29.0,M,"I received the Moderna Covid-19 Vaccine EUA on January 7th 2021 around 11:15AM. there were no initial side effects. I started Experiencing the listed side effects from the morning of January 8th, 2021 to the morning of January 9th, 2021. It started with light muscle and joint pain at 8am and progressed to sever muscle and joint pain, chills, nausea, fatigue, headaches and eventually a fever averaging at 100 degrees Fahrenheit by 1-2PM the same day. These side effects were enough to leave me bedridden for most of the 8th. most side effects were gone by the morning of the 9th, the fever eventually broke by 930Am on the 9th.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,SEN,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,SYR 931919,PA,58.0,F,"On the day of taking the vaccines had joint pains all over mainly involving the arms but they subsided. On the next day noticed redness and pain in the left eye. On 1/6/21 noticed diminished vision and blurriness in the left eye. Called opthalmology ED and was seen the next day on 1/7/2021 morning . Was diagnosed with left uveitis. I was seen by the on call doctor. There are many doctors involved in my care. My previous episodes of uveitis have been mostly in the right eye and the vision was not affected, The doctors involved in my care are not sure if this was just a coincidence, was an exacerbation of the preexisting pathology or was something new. I have asked to put the eye drops every hourly but the vision has not completely improved. I don't use the eye drops in the night and when I get up in the morning it is still very hard to read. It is an unusual episode of uveitis as typically my left eye is not involved and I have never had this much diminished vision , I am supposed to put the drops every one hourly until 1/11/2021. I have informed my PCP, Rheumatologist, regular eye doctor. I will inform my ID doctor Dr .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,"Cosentyx 150 mg every 3 weeks Metoprolol 100 mg ER daily Metformin 500 mg BID Losartan 50 mg daily Atorvastatin 10 mg daily Exemestine 25 mg daily ( Aromatase inhibitor, hormonal chemotherapy) Pentasa 500 mg 2 caps BID",Seronegative arthritis History of breast cancer on oral chemo s/p surgery and radition Hypertension Type 2 DM Hyperlipidemia Crohn's disease stable asymptomatic diagnosed on colonoscopy and biopsy,All the above conditions in item 11. Was very stable and working full time . Technically conditions in item 11 are all chronic conditions. In addition there is a history of uveitis involving mostly r eye in the past last episode 3 years ago.,,Lisinopril: cough,"['Arthralgia', 'Eye pain', 'Ophthalmological examination', 'Uveitis']",UNK,PFIZER\BIONTECH,IM 931920,UT,43.0,M,"Fever, chills, headache, sweats, tired",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Pyrexia']",1,MODERNA,SYR 931921,IL,50.0,M,"12 minutes after receiving the 2nd covid vaccination, I felt flushed and became diaphoretic. I felt heart palpitations and checked my heart rate which was 117, increasing to a max of 123. I was placed on a pulse ox monitor, which showed 93%, BP was elevated at 146/85. I was not given any medical treatment, and was placed on a monitor for one hour. Once my hr and 02 stas were at my baseline, I was allowed to be discharged. I went back to my department and decided to go home, as I felt tired and was mildly nauseous.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Escitalopram 20 mg po qd Lithium 900 mg po qpm Atorvastatin 40 mg qpm Clonazepam 0.5 mg po bid,None,Asthma Sick sinus syndrome-pacemaker,,Levaquin-hives,"['Fatigue', 'Flushing', 'Heart rate increased', 'Hyperhidrosis', 'Nausea', 'Palpitations']",2,PFIZER\BIONTECH,IM 931922,CT,29.0,M,"Chills started around 4AM while sleeping. Joint pain, malaise, headache, and localize pain at site of injection upon palpation upon awakening and still continues at the time of this writing (27 hours post-inoculation). No fever noted (99.3 F at 8AM). ONE Acetaminophen ER 650 mg TABLET was taken at 1PM.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,Multivitamin,N/a,N/a,,"Dust mites (mild reaction - runny nose, itchy eyes)","['Arthralgia', 'Chills', 'Injection site pain', 'Malaise']",2,PFIZER\BIONTECH,IM 931923,CA,34.0,F,"Approximately 5 minutes post injection, I felt a burning sensation move from my left deltoid, up my shoulder, and across my chest. I experienced burning in my chest for about 10 mins, and then it subsided. About 8 mins after that, I experienced moderate to severe cramping in my lower back and thigh muscles; which completely subsided after 10-15 mins. Two days after the initial injection, the injection site began burning/aching again, with movement up to my shoulder joint. It was to a point where I was tearful and unable to sleep. The following morning it had subsided, and just remains slightly sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,Adderall 10mg,None,None,,None,"['Chest pain', 'Injection site pain', 'Muscle spasms', 'Pain', 'Sleep disorder', 'Tearfulness']",1,MODERNA,IM 931924,DE,60.0,F,"Had initial vaccine on 12/21/2020. Broke out in rash reported in a previous report file. After 2nd injection, at some of the exact locations of healing rash from 1st, new eruptions of red raised pruritic rash occurred. Lower abdomen, top of right ribs and nape of neck.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,Levothyroxine. Trintella. Toprol. Entresto. crestor. Zetia. MVI. GENERIC Zyrtec.,None,"HTN. cardiomyopathy, resolved.",,Restoril causes hives on back for few hours,"['Rash', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",2,PFIZER\BIONTECH,IM 931926,CO,37.0,M,Extreme fatigue/muscle soreness and hypersensitive skin concurrent with alternating hot flashes with profuse sweating and cold flashes with shivering.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,None,None.,Celiac disease,,Celiac disease,"['Chills', 'Fatigue', 'Hot flush', 'Hyperaesthesia', 'Hyperhidrosis', 'Myalgia']",2,PFIZER\BIONTECH,IM 931927,NJ,52.0,F,Seizure/focal approximately 10 minutes after injection lasted 1-1.5 minutes....,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Carbamazepine 400mg TID/ Onfi 20 mg AM and 30mg PM/calcium withD 500mg/Rosuvastatin 20mg PM/Ezetimibe 10 mg PM,Epilepsy,Epilepsy and high cholesterol,,Pepcid and Decadron,"['Condition aggravated', 'Electroencephalogram', 'Laboratory test', 'Partial seizures']",1,MODERNA,IM 931928,,33.0,F,c/o chest pressure then lightheaded,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PVT,,,,,,"['Chest discomfort', 'Dizziness']",1,PFIZER\BIONTECH,IM 931929,MD,40.0,F,Mensuration started within 24 hours and 2 weeks early in cycle.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,WRK,,,,,,['Menstruation irregular'],1,MODERNA,IM 931930,IN,28.0,F,"I woke up 1/9/2021 around 09:00. I got out of bed at 09:30 and experienced severe weakness, lightheaded, dizziness, and drowsiness. This has been happening all day. I have no energy and just feel extremely weak",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,PVT,"Crestor, zetia, klonopin, lexapro, Zyrtec",Allergies,"High cholesterol, anxiety, allergied",,None,"['Asthenia', 'Dizziness', 'Somnolence']",1,MODERNA,IM 931931,NH,50.0,F,Deltoid area very sore surrounding where vaccine was administered (moving arm and to the touch),Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,OTH,Vitamin D; multi vitamin Omega 3,None,None,,None,"['Injection site pain', 'Pain']",1,MODERNA,SYR 931932,NY,50.0,F,Tingling and a feeling of numbness to R side of face,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Lisinopril/ hctz,None,Hypertension,,None known,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 931933,MI,55.0,F,"Severe right arm pain initially, about 8 hours post infection. Body aches, profound fatigue, chills and dizziness starting 10 hours post injection and persist entire next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PVT,Aleve,None,Chronic cluster/migraine HTN,Shingles,Ceftriaxone,"['Chills', 'Dizziness', 'Fatigue', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 931934,GA,35.0,F,"Immediately after immunization, Pt reported feeling ""light-headed, strange, having an out of body experience"". Increased heart rate (134/m). A&O x 3. Warm, dry. Adult Emergency called and team responded within 2 mins. Pt states symptoms improving rapidly. Transported to ED w/o delay.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,Medications Outpatient Medications at End of Encounter on as of 1/9/2021 Disp Refills Start End FLUoxetine (PROZAC) 20 mg Oral Cap 90 capsule 0/0 11/20/2020 11/20/2021 Sig - Route: Take 1 capsule by mouth daily - Oral Class: Fill Now SYN,"as of 1/9/2021 ICD-10-CM Priority Class Noted - Resolved HX OF ELECTIVE BREAST AUGMENTATION 10/12/2015 - Present Overview Saline implants 2004 CIN 1, MILD CERVICAL DYSPLASIA 10/23/2015 - Present Overview Pap October 2015 and July 2016. Previous Version GENERALIZED ANXIETY DISORDER (Chronic) 12/15/2015 - Present ACNE 9/12/2017 - Present FHX OF HERITABLE DISORDER 12/5/2017 - Present Overview FOB's family has hx of hereditary spastic paraplegia, couple rec'd genetic counseling, more information on hereditary type needed if couple considering testing, pt says was advised at the genetic consult she could do harmony screen Previous Version",See above,,No Known Allergies,"['Autoscopy', 'Dizziness', 'Feeling abnormal', 'Feeling hot', 'Heart rate increased']",1,PFIZER\BIONTECH,IM 931935,CA,41.0,F,"Redness , swelling and itchiness at injection site x 9 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,WRK,Vitamin D2,None,Hx of asthma and seasonal allergies.,,"Bactrim, azithromycin, mango","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 931936,CO,41.0,M,"Developed minor stabbing pain in L temporal/occipital region. Intermittent within first ten minutes. Also felt slight sharp pain in meatus of L hand within first 30 minutes. Also intermittent and resolved within a few hours. Slight headache the following day that would come and go. Developed L side abdominal sharp pain (4/10) within one hour. Pain persisted for more than 24 hours, is tender to palpation. Developed stuffiness and slighlty itchy eyes in first 30 minutes. Had some minor skin itching in various places with no discernible hives. I develped a brief hive 12 hours later on my leg but it is not uncommon for me to get an occasional hive on my skin as I have sensitivites to various fabrics, etc.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,UNK,,,,,possibly Sulfa,"['Abdominal pain', 'Eye pruritus', 'Headache', 'Nasal congestion', 'Pain', 'Pruritus', 'Tenderness', 'Urticaria']",1,MODERNA,IM 931937,NY,26.0,F,"Right side of face started to swell with blotching. It then went away . Injection site is raised , swelling and itching along with bruising . Hives began again on my arms and injection site .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,,,Clotting disorder,,Coconut oil,"['Injection site bruising', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria', 'Rash macular', 'Swelling face']",1,PFIZER\BIONTECH,SYR 931938,,37.0,F,"Delayed hypersensitivity reaction occurring 11 days after first dose. Redness, itchiness occurring at the site of injection. Treatment with OTC antihistamines.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/08/2021,9.0,PVT,None,None,None,,Sulfa antibiotics,"['Injection site erythema', 'Injection site pruritus', 'Skin reaction']",1,MODERNA,SYR 931939,AZ,41.0,F,"Fever, chills, weakness, myalgias, near syncope, increased heart rate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,Spironolactone,None,Acne,,"Minocycline, doxycycline, pumpkin, spaghetti squash","['Asthenia', 'Chills', 'Heart rate increased', 'Myalgia', 'Presyncope', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931940,CO,41.0,M,"Developed minor stabbing pain in L temporal/occipital region. Intermittent within first ten minutes. Also felt slight sharp pain in meatus of L hand within first 30 minutes. Also intermittent and resolved within a few hours. Slight headache the following day that would come and go. Developed L side abdominal sharp pain (4/10) within one hour. Pain persisted for more than 24 hours, is tender to palpation. Developed stuffiness and slighlty itchy eyes in first 30 minutes. Had some minor skin itching in various places with no discernible hives. I develped a brief hive 12 hours later on my leg but it is not uncommon for me to get an occasional hive on my skin as I have sensitivites to various fabrics, etc.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,UNK,,,,,possibly Sulfa,"['Abdominal pain', 'Abdominal tenderness', 'Eye pruritus', 'Headache', 'Nasal congestion', 'Pain in extremity', 'Pruritus', 'Urticaria']",1,MODERNA,IM 931941,MN,32.0,M,"The following day I became increasingly fatigued, roughly 30 hours later I took a 2 hour nap. I awoke and had dinner, about 5 minutes after finishing my heartbeat felt 'regularly irregular' and was 55 bpm, which is normal for me at rest. I became nauseous, dizzy, full-body tingling, laid on the floor near the toilet for about 20 minutes. My wife reported my lips became purple and I was pale. I assumed it was hypotension (vasovagal?) of some kind as I've had this happen after blood draws in the past. I drank a bunch of water to get my blood pressure up and smelled peppermint oil to decrease nausea. I was okay thereafter, but I slept around 13 hours that night.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,15mg cetirizine daily,none,asthma,"Pertussis - leg swelling, few years old","pertussis vaccine (as a child), cephalexin","['Dizziness', 'Fatigue', 'Heart rate irregular', 'Hypotension', 'Lip discolouration', 'Nausea', 'Pallor', 'Paraesthesia']",1,MODERNA,IM 931942,MA,33.0,F,"At 6 days after the vaccine, I developed some itching and mild swelling at the injection site. The next 2 days it became progressively more itchy, and I noticed progressive redness, warmth, and swelling to about 6-7 inches in diameter around the injection site despite using topical hydrocortisone. I was seen by virtual urgent care 8 days after the vaccine, and the doctor recommended around the clock ibuprofen for what he thought was a delayed hypersensitivity response, which helped. It resolved after 4-5 days of intermittent ibuprofen (400mg about twice a day) and topical hydrocortisone. I never had fever or other systemic symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/01/2021,6.0,PVT,"Cetirizine, flonase nasal spray, one-a-day multivitamins",None,Allergic rhinitis,,CT contrast (hives),"['Hypersensitivity', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 931943,IA,34.0,F,Developed rash on back and chest/stomach approx 19 hours after injection . Itchy all over Eye itchiness developed 4 hrs after injection Other symptoms were Muscle and body aches Slight cough Sore throat Face puffy Fatigue Chest heaviness (o2 levels stayed 100 percent ),Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Levothyroxine Propanalol Multi vitamin,None,Hypothryoid Tachycardia,,Poultry anaphylatic reaction Codine Perm solution hair,"['Chest discomfort', 'Eye pruritus', 'Fatigue', 'Myalgia', 'Oropharyngeal pain', 'Pain', 'Pruritus', 'Rash', 'Swelling face']",1,PFIZER\BIONTECH, 931944,PA,38.0,F,"Nausea , Headache, body ache, sore throat, runny nose, fever 100.2 F, soreness in L arm, palpitations.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,Tylenol,Nond,Nond,,Shell fish,"['Headache', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Palpitations', 'Pyrexia', 'Rhinorrhoea']",UNK,MODERNA, 931945,WV,58.0,F,"Facial tingling and numbness, left side of face (same side as shot). Lasted for several hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,WRK,none,None,None,,"Doxycycline, IVP dye","['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 931946,OH,29.0,F,"Very sore arm, moderate body aches, moderate fatigue, minor headache, and sharp pains in left abdominal when eating.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,Claritin D and Flonase,Chronic allergies,Chronic allergies,,None,"['Abdominal pain', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity']",UNK,MODERNA, 931948,,30.0,M,"30 year old healthy male with no preexisting conditions who developed morbiliform rash on the trunk, upper back, and inguinal creases bilaterally, 36 hours after 2nd dose of Pfizer Vaccine. The rash spared the mucosal membranes, face, and extremities. The rash was not itchy or painful. No co current fever or other systemic symptoms. Patient does not have history or drug, vaccine, or food allergies. In particular, no known allergy to polyethylene glycol. Patient does not take any medications daily, though took acetaminophen and Ibuprofen at the time of vaccine and then for the next 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,UNK,Tylenol and Advil,None,None,,None,"['Rash', 'Rash morbilliform']",2,PFIZER\BIONTECH,SC 931949,CA,25.0,F,"Muscle aches starting at 3pm 1/9/21, progressing into the e night",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,UNK,N/a,N/a,N/a,,N/a,['Myalgia'],UNK,MODERNA, 931950,FL,28.0,F,"Chills, headache, burning sensation in both eyes, body ache, nauseas, lack energy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PUB,Ibuprofen 800 mg and Gabapentin 100 mg I took las night for leg pain Montelukast and cetirizine for allergies,Leg pain,Asthma,,No,"['Asthenia', 'Chills', 'Eye irritation', 'Headache', 'Nausea', 'Pain']",1,MODERNA, 931951,CA,40.0,M,"PATIENT RECIEVED THE FIRST DOSE OF MODERNA VACCINE AT HOSPITAL, COVID CLINIC. RN OBSERVING NOTICE THE PATIENT STARTED GETTING ANXIOUS AND WANTED TO MOVE AROUND AND LAY ON THE FLOOR. PATIENT STARTED TO TURN PALE AND WAS COMPLAINING OF BEING WARM. RAPID RESPONSE WAS CALLED. PATIENT STARTED TO LEAN BACK IN THE CHAIR BUT WAS CONSCIOUS THE WHOLE TIME. RAPID RESPONSE TOOK THE PATIENT TO THE ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,,,,,,"['Anxiety', 'Feeling hot', 'Pallor']",1,MODERNA,IM 931953,WA,32.0,F,1/2/21 extreme soreness 4 hours after until 36 hours after. Rash presented on 1/8 evening and is very itchy. Injection site is swollen and a bit firm. Rash is present and ongoing.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/08/2021,6.0,PUB,Ritalin,N/a,N/a,,Amoxycillin,"['Injection site induration', 'Injection site swelling', 'Pain', 'Rash pruritic']",1,MODERNA,IM 931954,MA,32.0,F,immediate facial tingling right side. resolved within 5 seconds- did not return during the 30 minutes of observation following the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,ferrous sulfate,unknown,unkown,,unknown.,"['Immediate post-injection reaction', 'Paraesthesia']",1,MODERNA,IM 931955,IL,28.0,M,"Injection site soreness, fever, nausea, chills, headache, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,,Covid-19,,,,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931956,NJ,36.0,F,"!2 hours after 2nd dose of vaccine experienced sudden onset of Headaches, chills, muscle aches, sweats, diaphoretic / pale clammy skin, fever, and joint pain. all the fore mentioned symptoms were not all at once, every half hour and not all once. some symptoms lingered longer than others.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,SCH,no,no,no,,no,"['Arthralgia', 'Cold sweat', 'Feeling cold', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Pallor', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931957,NH,57.0,M,"3 am chills, headache and dry throat, 9:30 am chills, headache and dry throat and I took my first temp 102. took two Tylenol and temp went down. 8Pm I was flush and my temp was 105.5, 5minutes later 106. PCP called and advised my wife to take me to the ER and took two more Tylenol. Arrived at ER Temp was down 100.2",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/04/2021,1.0,PVT,"Gemfibrozil 600mg D3 200 Mcg, Fish Oil 600mg, Cranberry 25,200, Irwin Prostra Strong, Nature Made Super C, Magnesium 500mg, One Daily Multivitamin.",None,Herpies,,None,"['Blood test normal', 'Chills', 'Dry throat', 'Flushing', 'Headache', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH,IM 931958,MA,28.0,M,"On the day of the vaccine, 1/7 no reaction. The typical slight sore arm on injection site but nothing odd. On the morning of 1/8 I woke up with noted chills and headache. I checked my temp and noticed 100.4* oral temp. I also had back pain, muscle pain, headaches, continued fever (improved with motrin) and chills. My left arm from my shoulder to my wrist was with noted pain/aches, improved with motrin. On the morning of 1/9 I felt much better, did not take any motrin/tylenol and without any fever/chills. Noted improvement of muscle aches in general and arm felt the same as 1/7 (much better!). Noted lymph swelling of my axillary lymph nodes with aching pain. This has not gone away at current but improved with x1 dose of motrin.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,None,None,,,Sulfa,"['Arthralgia', 'Axillary pain', 'Back pain', 'Chills', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931959,TX,45.0,F,"I waited 30 minutes after the vaccine. No issues and went back to work. At 70 minutes after shot administration, felt itchy on limbs, then trunk and neck, then ears, eyes and into scalp. Symptoms progressed over the next 2 hours (flushed neck and then lips felt tingly and numb). At 7:30 my soft palate started to feel numb and I started to have some difficulty swallowing. Went to ER. Symptoms continued. After IV meds given swallowing difficulty continued to worsen so I was given a low dose shot of Epi. Swallowing improved (not to normal but not as severe) over the next hour but itchiness returned. It is now 8:00pm on 1/9/2021 and I continue to have itchiness, my tongue and soft palate are still numb but I am able to swallow fairly well and my entire face has decreased sensation to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,Vitamin D supplement Flonase (in the morning) Xyzal allergy medication (in the morning),No illnesses,None,,"Penicillin Fish (I can eat shellfish but am allergic to fish like halibut, salmon)-I will get hives, severe facial swelling. I have had allergic reactions to celery in the past (hives, facial swelling). I also have seasonal allergies (they have been worse this fall and winter-pollen count has been high the past month in Ft. Worth)","['Ear pruritus', 'Eye pruritus', 'Flushing', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia oral', 'Pruritus', 'Vital signs measurement']",2,PFIZER\BIONTECH,SC 931960,FL,24.0,F,Severe right arm pain and muscular pain at injection site prompting patient to come into Emergency Department for care. Patient took Tylenol and Ibuprofen with no relief in symptoms. Patient also had low grade fever of 99.4,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,None.,None,None,,Allergies to codeine (vomiting),"['Injection site pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 931961,NJ,41.0,M,"Light-headed, extreme cold in hands. Started approximately 2 hours after injection and lasted for about 4 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,,,,,,"['Dizziness', 'Peripheral coldness']",1,MODERNA,SYR 931962,AZ,77.0,M,"Upper lip, left cheek, part of right cheek swelled up. We have pictures with times pictures were taken from different angles. Ice was applied and generic Benadryl was given, 2 tables. Swelling started at 5 pm, continued to increase until approx 8:30 pm. Upon waking face was still swollen the next day. Swelling started to decrease noticeably approximately noon on the 9th. By 7pm on the 9th most swelling had decreased, except for left lower cheek and upper lip still had noticeable swelling. This report is being filled out at 7:10pmon January 9, 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"gabapentin 300mg, flomax, Flonase, allergy pill with 25mg Diphenhydramine.",None,None,,None,"['Lip swelling', 'Swelling face']",1,MODERNA, 931963,TX,25.0,F,"Immediately after vaccine I had a bad headache which was cleared up with Ibuprofen. Then 12 Hours after vaccine my arm became VERY sore, took my ibuprofen and alternated with Acetaminophen. Then my face became very flushed (I used ice packs) and I got a mild sore throat. That night I had difficulty sleeping. I kept waking up with terrible body aches. About 24 hours after the vaccine I just had fatigue, mild fever, and chills. I slept on and off throughout the day and then started to feel better. But at about 32 hours post vaccine I started to feel worse. My headache and sore arm came back and I became very light headed and dizzy.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,"Supplements: Fish oil, magnesium, vitamin B12, and calcium. Prescription meds: Adderall, Xyzal, Singulair, Lo loEstrin 24 Fe, and protonix.",None,"ADHD, seasonal allergies, and anxiety.",,"Kiwi, latex","['Chills', 'Dizziness', 'Fatigue', 'Flushing', 'Headache', 'Immediate post-injection reaction', 'Insomnia', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931964,IL,30.0,F,"severe body aches, swollen and painful lymph nodes in both armpits and bilateral neck, achy joints and muscles, headache, achy eyes, extreme tiredness, itchy all over and swollen, painful and itchy injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,"fluoxetine, propranolol",,"anxiety, depression","body aches, tired",,"['Arthralgia', 'Eye pain', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Lymph node pain', 'Lymphadenopathy', 'Myalgia', 'Pain', 'Pruritus']",2,PFIZER\BIONTECH,IM 931965,SC,39.0,M,"Highest temp of 101.9, chills, muscle and general fatigue, joint pain, headache and stomach cramps",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"Novolog insulin, zoccor, lasinapril, Flonase, Zyrtec, vitamin d3, super b complex, b1, and milk thistle",None,"Diabetes type 1, hypertension, hyperlipidemia and seasonal allergies",,None,"['Abdominal pain upper', 'Arthralgia', 'Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Muscle fatigue']",2,PFIZER\BIONTECH,IM 931967,MA,27.0,F,"Symptoms that began at 10pm the night I reviewed the vaccine included chills, fever, body aches. This lasted till about 2am. Finally fell asleep and woke up at 8am very sore but much better. Around 3:30pm I started again with the same severe chills, fever, body aches and now nausea. Woke up in the middle of the night drenched in sweat. The following morning I woke up around 8am again with horrible mid/lower bilateral back pain. This lasted till about 1pm. It?s not 9pm and all symptoms have subsided. I feel hopeful, thanks for all you do!",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,None,None,None,,None,"['Back pain', 'Chills', 'Hyperhidrosis', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931968,TX,52.0,F,"Headache, chills, fever 100.6 �F, fatigue; acetaminophen 500mg; symptoms abated 24h after vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PUB,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931969,IN,27.0,F,"I woke up the morning after my shot and I had some pain around my left clavicle when putting pressure on it (turning in bed, etc. ) and I felt around and there was a small lump. Seems like a swollen lymph node. Today (2 days later), the area is more tender and a little larger upon palpation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,OTH,"Zoloft 100mg, probiotic,",None,"Depression, anxiety",,None,"['Neck pain', 'Nodule', 'Tenderness']",UNK,PFIZER\BIONTECH,SYR 931971,NJ,37.0,F,"Severe Headache, over 12 hours. Relieved by Tylenol and rest.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PUB,"Synthroid, multi vitamins",,Hypothyroidism,,,['Headache'],1,MODERNA,IM 931972,WA,61.0,F,"First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next day. Dose two given on 01/07/21 with onset of shaking chills on 01/08/21 at 2:00am, ensuing fever max 101.7 degrees Fahrenheit, at 4:00 am noticed redness of eyes, face flushed with burning feeling, headache, dizziness, blood pressure of 184/96 and heart rate of 153. This required medical evaluation and treatment with IV fluids and Toradol for resulting headache. Patient also self administered 1000mg oral Tylenol prior to ER evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Metoprolol, atorvastatin, omeprazole, vitamin/mineral, calcium, glucosamine, Co-Q 10, elderberry syrup, ciprofloxacin, Flonase.",E. coli urinary tract infection on day 5 of 7 days of ciprofloxacin.,"Hypertension, hypercholesterolemia, hemophilia A (von Willebrand?s Disease),",,"Paxil, erythromycin, sulfa.","['Burning sensation', 'Chills', 'Dizziness', 'Electrocardiogram', 'Flushing', 'Full blood count', 'Headache', 'Heart rate increased', 'Metabolic function test', 'Musculoskeletal stiffness', 'Ocular hyperaemia', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 931973,,33.0,F,Chills and high fever 100.5,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,UNK,Ibuprofen,None,None,,None,"['Chills', 'Pyrexia']",1,MODERNA,SYR 931974,OH,38.0,F,"Headache, nausea, chills, body aches, low-grade fever everything started by 1630 on Thursday afternoon",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Lamictal 150mg QD,,HX of seizures,,,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,SYR 931976,AK,65.0,F,"Expected: low grade tenderness at vaccine site, identified at 10 hours post injection, slightly worse on awaking 22 hours post injection. 0700 (22 hours post injection) visual swelling of left supraclavicular lymph node, Node is palpable, slightly tender, mild swelling around the node.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,None,No illness identified,,"Shingrix vaccine, dose #2, received in summer 2018 age 62","Codein sensitivity, otherwise no allergies","['Injection site pain', 'Lymph node pain', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 931977,KS,47.0,F,10 minutes after getting vaccine I had a heart rate of 122 just sitting in a chair. Went to a separate observation room. Heart rate went up to 132. Oxygen level was 97 or higher the whole time. Felt a little shaky. Nurse said I was flush and a little blotchy. Heart rate went down to 84 and went back up to 115 then went down and stayed down. I felt hot initially.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,Taking vitamins and nutrients by using Thrive,Seasonal allergies Headache Runny nose Sinus pressure Watery eyes,None,,Cephalosporins,"['Feeling hot', 'Flushing', 'Heart rate increased', 'Nervousness', 'Rash macular']",1,MODERNA,SYR 931978,OH,30.0,F,Lost hearing in right ear. Developed severe tinnitus with hearing loss on the date after vaccine was administered. Initially developed rash near injection site. Rash has spread down entire right arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,WRK,Pepcid Emgality Victoza Zoloft Topiramate XR Nurtec Zofran,"Diagnosed with Covid-19 on 12-4-20, no longer symptomatic. Symptomatic from 11/22/20-12/2/20. Diagnosed with pre-procedure covid test incidentally.",Migraines Polycystic Ovarian Syndrome Kidney Stones Asthma PTSD w/ Depression,,Cortisporin otic Barley Coconut,"['Acoustic stimulation tests abnormal', 'Cerumen removal', 'Deafness unilateral', 'Injection site rash', 'Rash', 'Tinnitus']",1,MODERNA,IM 931979,NM,23.0,F,"Numbness in the pinky, ring finger and palm of the right hand",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,SEN,Famotidine,,,,None,['Hypoaesthesia'],1,MODERNA,IM 931980,KS,45.0,F,"Sore Arm where injection was given, Temp of 100.2, Hiccups for 2 hours on the morning of 01/09/2021 (hiccups are not something that I normally get, if I do I only hiccup 3-4 times on average",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,"Coreg, Valsartan, Effexor, Armidex",none,none,"sore arm, bodyaches, chills usually every year with the FLU vaccine",Sulfa erythromycin,"['Body temperature increased', 'Hiccups', 'Injection site pain']",2,PFIZER\BIONTECH,IM 931981,WA,38.0,F,"Facial rash, extended to back of neck within 10 minutes of vaccine injection No rash at injection site Increased blood pressure and pulse Normal Oxygen saturation Transport to Hospital Emergency Room at 1615 No medicines given in Emergency Room Discharged from emergency room without complications at 1842",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,None,None,None,,sulfisoxazole/erythromycin miconazole latex fragrance nickle,"['Blood pressure increased', 'Heart rate increased', 'Rash']",1,MODERNA,IM 931982,IN,31.0,M,"14 hours after getting the vaccine, I had rapid onset fever with Tmax 104F, chills, rigors, headache, nausea, and myalgia. This lasted nearly 4 hours and then spontaneously resolved without intervention.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,None,None,None,,NKDA,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 931983,OH,27.0,F,"Extreme fatigue in mid morning, with onset of one hour of waking and lasting for approximately 3 hours. No other apparent cause of fatigue or with any other symptoms .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,PVT,"Citalopram 20mg daily, Propranolol 20mg TID, Vitamin D 10,000 units weekly",None,Depression,,None,['Fatigue'],1,MODERNA,IM 931984,VA,50.0,F,"About 15 min after injection my heart started racing and I got lightheaded. Heart rate was 95+ and BP was 190/90 something. My resting HR is 56 and BP is usually around 120/80. Began to drop after about another 15 minutes. Followed by migraine for the rest of the day. Felt okay when I woke up, but had one episode during the day today in which my heart rate shot up again and was a little short of breath even though I was not exerting myself. Lasted about 10 minutes. Injection site hurts to the touch, but otherwise is painful. Throat hurts a little and a little congested, but probably unrelated.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,"Xanan, .25 mg",None,"Generalized anxiety, seasonal allergies, GERD",Flu vaccine,"Mold, grass, tree pollen, sensitivities (mostly itching) to Erythromycin, Doxycycline, Bupropion, Cephalosporins, Sulfamethoxazole-Trimethoprim, and had a reaction one time to the flu shot vaccination included racing heart, minor rash/hives, tightening of the throat.","['Dizziness', 'Dyspnoea', 'Injection site pain', 'Migraine', 'Oropharyngeal pain', 'Palpitations', 'Respiratory tract congestion']",1,PFIZER\BIONTECH,SYR 931985,OH,28.0,F,"Itching, erythema, warmth and pain over the left arm deltoid muscle. Pain is described as a sore ache that radiates down the arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/09/2021,7.0,PVT,None,"Viral illness early December, COVID negative",None,,None,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Pain', 'Pain in extremity']",1,MODERNA,IM 931986,KY,24.0,F,"1/7/2021- felt dizzy/nauseas about 30 minutes after injection. 1/8/2021 AM started having soreness in injection site, and some red spots on right hand. PM starting having extreme itching on dorsal sides of hands, used lotion that I normally use (sensitive skin kind) to see if it was just dryness. Red bumps still on just right hand 1/9/2021 woke up in middle of night to extreme itching and spreading red bumps on both hands. Bumps are small and fluid filled. Took Benadryl and went back to bed after washing hands. Early PM continued extreme itching and spreading bumps to wrists becoming more red and some bumps popping. Later in evening I noticed swelling starting in my hands. I have tried Benadryl cream (not difference) washing hands well (no difference) lotion (worse) hydrocortisone 1% cream (itching worse) swelling went from none to a non pitting edema. Hands hurt and swelling increasing over time more bumps showing up on hands (with no other changes to any products I have used)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Mirrana (IUD birth control),None,None,,Wasp stings,"['Abdominal pain', 'Dizziness', 'Injection site pain', 'Nausea', 'Peripheral swelling', 'Pruritus', 'Rash']",2,PFIZER\BIONTECH,IM 931987,TN,31.0,M,"Myalgias, Chills, hyperesthesia, Headaches, neck pains, fatigue, weakness. The day after the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Miralax Finasteride,None,None,,None,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Hyperaesthesia', 'Myalgia', 'Neck pain']",2,PFIZER\BIONTECH,IM 931988,PR,35.0,F,7 days later I had reaction all over my body rash all over the body,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/08/2021,9.0,UNK,,,,,,['Rash'],1,MODERNA, 931989,,56.0,F,"Fever 103.9 , headache, body aches, eye pain, fatigue Symptoms lasted for 48 hours. Fever responded to Tylenol but returned as Tylenol wore off.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,UNK,"Losartin, chlorthaladone, enalapril, Lipitor, aspirin, vitamin d, magnesium, Tylenol",Strep throat,"Asthma, hypertension,","Cellulitis requiring antibiotics and Er visits from flu, pneumovax and Shingrix","Flu vaccine, hydrazaline, levaquin, pneumovax, shin grid, blood products","['Eye pain', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 931990,KY,41.0,F,3 inch in diameter red welt appears at place of injection. Getting bigger every day. Warm to the touch. Aching arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,Lisinopril 2.5mg Lipitor 10mg Zyrtec 10mg Vitamin D 25mcg Airborne Vitamin C chewable (3 tablets day),None,CKD stage 3,,None,"['Injection site pain', 'Injection site reaction', 'Injection site warmth', 'Urticaria']",1,MODERNA,IM 931991,IN,55.0,F,"Fatigue, dull head ache, elevated blood pressure.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PUB,Levothyroxine 137mg Atorvastatin 20mg Bupropion 150mg Amlodipine-Benazepril 5-20mg ProAir and Advair (asthma),None,"Asthma, Graves Disease, Hypertension",,None known,"['Blood pressure increased', 'Fatigue', 'Headache']",1,MODERNA,IM 931993,NY,45.0,F,"Left arm pain began approx 1 hour from time of vaccination to present, pain much greater than that of flu vaccine Sharp left shoulder pain from approx 5 hours after vaccination to present 5 hours after vaccination left side of neck swelling and pain. Subsided overnight and gone by morning. Approx 24 hours after vaccination- left upper arm swelling approx 5"" in diameter. Redness at injection site approx size of quarter. Approx 15 hours after vaccination, experienced moments of heat flashes which subsided. Left arm swelling, left arm and shoulder pain still present with and without movement.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Ibuprofen Sertraline Duloxetine Vit D Metaprolol Verapramil Omeprozole Gabapentin Mirena IUD,None,Left leg Neuropathy Chronic back pain History spine surgeries X2 Morbidly obese High blood pressure Generalized anxiety d/0 PTSD,,Environmental allergies only. NKDA,"['Hot flush', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Neck pain', 'Pain in extremity', 'Swelling']",1,MODERNA,IM 931995,WA,65.0,F,"Uneasy stomach with very soft stools in every visit to the bathroom and on a few occasions in between. Awkward, to say the least. Started overnight after day of vaccination and has continued for over 24 hours and has not yet resolved although frequency has started to diminish as of 48 hours. Also visibly flushed face/hot flashes, slight rise in temperature at 98.4 (over my normal baseline of 97.5) this morning which has since receded. Waiting to see how long this lasts.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PUB,"Estradiol, Famotidine, Lisinopril, Amolodipine Besylate, standard multi-vitamin, 8 hour extended release tylenol",None,Primary Reynaud's Syndrome High blood pressure (well-controlled) GERD Normal age related arthritis,Sore arm for several weeks after flu shot about 5 years ago (approx age 60 yrs) interfering with ADL; have avoided flu shots si,sulfa,"['Abdominal discomfort', 'Faeces soft', 'Flushing', 'Hot flush']",1,MODERNA,IM 931996,NC,60.0,F,"on the first day around 4pm i got tired, sleepy, legs feel weak, a little chillness. Went to bed before 5:30. the next morning i was still sleepy could hardly move. some body ache and headache from the back of my head to front. third day still a little weak but not like day 1&2.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,SEN,omeprazole.,no,no,,Latex products. Percocet,"['Asthenia', 'Fatigue', 'Feeling cold', 'Headache', 'Mobility decreased', 'Muscular weakness', 'Pain', 'Somnolence']",1,MODERNA,IM 931998,CA,25.0,F,"At 5:45 PM on 1/6/21 the same day I received the vaccine I had a fever of 100.5, F, headache, chills, and severe pain at the site of injection. After one dose of 650 mg acetaminophen my temperature went back down to 98.6 F. The next day 1/7/21 I did not have a fever; I still had mild chills and headache and pain at the site of injection. For the pain I took 1,000 mg of acetaminophen at morning and at night which eased the pain. The following day 1/8/20 I did not have headache or chills and had very mild pain which was tolerable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,Multivitamin tablet Vitamin C 500 mg tablet,None,None,,None,"['Chills', 'Headache', 'Injection site pain', 'Pyrexia']",1,MODERNA,SYR 931999,IN,50.0,F,Developed a burn like area on left wrist area. 12 hours later began to develop blisters on right hand and right wrist. This was followed by blisters on the left hand and a blister over the reddened area on the left wrist. Also developed a reddened area on the top of the right thigh that developed a blister. All of this happened within 24 hours. 5 days after the onset of blisters the small blisters have dried up and now present as dark red spots on my skin. Still have a large blister present on the right ring finger. Right wrist blister was inadvertently hit and it busted. That blister was large like blister on right finger. Hands have become heat sensitive - warm shower water is very hot on hands. Hands feel like they are on fire at times.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/03/2021,4.0,PVT,"Pepcid 20mg QD, NP Thyroid 120mg QD, Progesterone 200mg QD,",None,None,,Penicillin,"['Blister', 'Blister rupture', 'Erythema', 'Skin discolouration', 'Temperature intolerance']",1,MODERNA,IM 932000,CA,38.0,F,"Fever to 102.9, fevers first started 12 hours after administration. Requiring constant antipyretics to decrease",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2020,01/08/2021,366.0,PVT,None,None,None,,None,['Pyrexia'],2,PFIZER\BIONTECH,IM 932001,OK,74.0,M,"chills, then woke up in night with body aches, nausea and fatigue. Tonight he has oral temp 100 deg. Nausea continues and body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,OTH,Gabapentin 100mg TID metropolol 20mg BID,none,"COPD, CAD kidney disease stg 3",,,"['Body temperature increased', 'Chills', 'Fatigue', 'Nausea', 'Pain']",1,MODERNA,IM 932002,OR,67.0,F,"No symptoms until 1 week after vaccine received. On 1/6/2020 at 8 pm, I noticed a nickel-size raised area at injection site. It was tender, itchy and moderately hard to the touch. No visible rash. Right upper arm appeared slightly swollen. It continued to increase in size, tenderness and itchiness for approximately 48 hours. On 1/8/2020 at approx 8 pm I noticed it was then a quarter-sized raised area at the injection site, It was more tender, itchy and hard than it had been. That was the worst it became. By the next morning, 1/9/2020, symptoms were significantly decreased. Currently, 1/9/2020 7:08 pm, the area is no longer visibly raised, tender or itchy. However, I can still feel a very slightly firm dime-sized area at the injection site. No fever, breathing problems or other side effects noted since getting the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,PVT,"Carvedilol 6.25 mg twice daily, Losartan 50 mg twice daily, Levothyroxine 25 mcg daily, Lovastatin 10 mg nightly, Albuterol inhaler as needed, Fluticasone nasal inhaler 2 puffs q nares daily, Aspirin 81 mg nightly, Vitamin D3 2000 units dai",mild intolerance to Cantaloupe - causes scratchy throat,"Allergy induced asthma Mild hypothyroidism, treated w/Levothyroxine Osteoarthritis Obesity",,None known,"['Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 932003,MO,43.0,F,"5 days after injection trigeminal facial neuropathic shingles, left side of face, C3, r arm, side",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,PVT,"Emgality, Cymbalta, Naprosyn 500 PRN, toradol",Nope,"Chronic Migraines, depression",,"Sulfa, codeine","['Herpes zoster', 'Trigeminal neuralgia']",1,PFIZER\BIONTECH,IM 932004,TX,25.0,F,"Onset of deep, what feels like, bone pain 5 days post vaccination. I had regular muscle tenderness 1 day post vaccination, that only lasted 1 day, but this feels much different. Still experiencing this discomfort. No other injury that would have caused this pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/05/2021,5.0,WRK,None. Had to take Benadryl after vaccination due to tingling on tongue.,None,PCOS,,PCN,"['Bone pain', 'Discomfort', 'Myalgia']",1,MODERNA,IM 932005,MI,30.0,F,"Tingling hands, difficulty breathing, face felling hot and swollen - started almost immediately after injection. Benadryl was given and EMT advised going to the hospital for observation. Heart rate and bp returned to normal a few hours later. Still feel dizzy and lightheaded when standing. Was informed that it was a vasovagal reaction. Arm is also very sorry at injection sight. Left arm where injection was placed it still tingling in hand, right hand feels normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,UNK,Probiotics and garlic supplement,None,None,,None,"['Dizziness', 'Dyspnoea', 'Feeling hot', 'Immediate post-injection reaction', 'Injection site pain', 'Pain in extremity', 'Paraesthesia', 'Swelling face']",1,PFIZER\BIONTECH,SYR 932006,WI,20.0,M,"Pfizer-BioNTech COVID-19 Vaccine EUA The vaccine was administered to the writer at 0800 on 1/5/2021. No immediate reactions were noticed for the 30 minutes observation period immediately after. The writer's muscle that received the vaccine began to become increasingly sore throughout the day; however, that was similar to the first dose of the same vaccine a few weeks prior. The pain was described as constant (2/10) but aggravated with motion. The pain did interfere with the writer's normal range of motion (specifically raising the writer's arm above shoulder height). From 0800-2200 on 1/5/2021 no noticeable symptoms except for the injection site pain occurred. At 2200, the writer rapidly developed chills, body aches, a headache, fatigue, and a fever of 100.8. These symptoms were left untreated and continued through the night (the symptoms did not interfere with sleep). The writer woke up at 1300 on 1/6/2021; all previous symptoms had resolved by this time except for the injection site pain. By 1400 on 1/6/2021, the writer noticed pain near the right axillary lymph nodes. The pain can be described as moderate (1/10) and generally occurred only with motion. The writer was unable to palpate any swelling in the area. Around 1800 on 1/6/2021, the writer noticed it felt weird to swallow. Specifically, it felt as if there was a slight internal swelling 1-inch subhyoidally and 1-2 inches laterally within the right side of his neck when he swallowed. The swelling was not palpable from the skin's surface. The writer did not seek medical attention as breathing/eating/drinking were not made more difficult but monitored this closely. The swelling in the neck resolved by 2000 on 1/6/2021. The lymph node pain in the right arm resolved over the course of a few days and was no longer present by 1/9/2021 at 1300.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,No known conditions,,"Ascospores, Hamsters, Seasonal Pollen, Grass Pollen","['Axillary pain', 'Chills', 'Dysphagia', 'Fatigue', 'Headache', 'Pain', 'Pyrexia', 'Swelling', 'Vaccination site pain']",2,PFIZER\BIONTECH,IM 932007,ID,38.0,F,Severe Soreness at injection site (>24 hours) Mild weakness in arm (injection arm),Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PHM,"Levothyroxine, methylphenidate",Ear congestion,"Degenerative disc disease, obesity, hypothyroid, ADHD, anxiety",,Tetracyclines,"['Injection site pain', 'Muscular weakness']",1,MODERNA,IM 932008,NY,39.0,F,About 3-5 minutes after I felt so out of it. I felt like I was under the influence of something. I tried to read my email and the words were there but didn't have meaning. I had to drive home after my 15 minute observation and plugged my home address into my gps so I wouldn't get lost even though I drove home from Medical Center for years. I got home and laid down and slept for a couple hours and woke up fine. I felt ok the following day and was doing laundry around 6 pm and my arm stopped being sore and I got really dizzy and nauseated and my vision had shadows (reminded me of an ocular migraine) and drank 2 x 16 oz glasses of water and laid down and felt better in about 20-30 minutes.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,Levothyroxine 150 mcg daily Ibuprofen 400 mg 2 hours before for cramps Vit d 4000 units daily,Na,Hashimoto's thyroiditis with nodule hemi thyroidectomy,,Sulfa,"['Disorientation', 'Dizziness', 'Feeling drunk', 'Nausea', 'Photopsia', 'Somnolence']",1,PFIZER\BIONTECH,IM 932009,NY,59.0,F,"Body aches, headache, nausea, chills, 100.2 temperature, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,None,None,None,,PCN,"['Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain']",UNK,MODERNA,IM 932010,NJ,30.0,F,"Low grade fever 1/8/21-1/9/21 max temperature 100.5 F, increased arm pain on left side 1/8/21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Fish Oil 2000 mg daily,None,None,,"Amoxicillin, Doxycycline","['Pain in extremity', 'Pyrexia']",1,MODERNA,IM 932011,CA,54.0,F,"After removing the vaccination needle from my arm post first vaccination attempt, the vaccinating nurse examined the syringe for several seconds as if she suspected that something had not functioned correctly. As she was examining the syringe, a stream of fluid under pressure emerged from the end of the syringe and fell to the floor. I was VERY concerned that a significant portion, if not the entirely of my dose volume, had been ejected from the syringe only AFTER it left my arm, and that, therefore, I had likely NOT been administered a therapeutic volume of vaccine. I advised the supervising physician of my observation and my grave concern. After consulting with the CDC and other advisors, the supervising physician agreed to authorize that I immediately receive a ""second"" first dose. I received the ""second"" first dose in the opposite arm within about an hour of having received the first dose. I was observed for fifteen minutes, and then went home without further event. That evening and the following day I experienced mild arm soreness at the site of the first injection, and significant arm soreness at the sight of the second injection. I never experienced any other side effect.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,none,none,none,,sulfur-based food preservative,"['Extra dose administered', 'Injection site pain', 'Syringe issue', 'Underdose']",1,MODERNA,IM 932012,NY,60.0,F,"Started Day 10 with redness, at near injection site- slightly below. Warm to touch about 4 cm Day 11 increased in size to about 8.5 cm warm to touch. by evening became slightly swollen. Day 12 redness slightly decreased in the center, but more swollen. Less warm No fever- but feel tired. Arm feels slight achy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,WRK,no,None,Mild Diabetes type2 Rheumatoid Arthritis,,no,"['Fatigue', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 932013,NY,25.0,F,"Fever, congestion, body aches, cough",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,None,None,PCOS,12/18/20 fever and chills after first dose of Pfizer vaccine,"Apple, pears","['Cough', 'Pain', 'Pyrexia', 'Respiratory tract congestion']",2,PFIZER\BIONTECH,IM 932014,MI,43.0,F,"MODERNA COVID-19 Vaccine EUA 12:30 am fever, chills, aches in bones, headache, inability to sleep. 6:30 am fever, chills, aches, headache. With 2 Tylenol, fever broke and was able to sleep some. 12:30 pm on 1/9/21 fever returned. Ongoing aches, headache. Took 2 more Tylenol.. 3-5 pm symptoms seemed to resolve, but then fever returned. At 7:15 pm, temp was 100.3 (baseline is 97.4). Took 2 more Tylenol and fever resolved. Still achy some.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,Levothyroxine Acid Reducer,None,Acid reflux,,Sulfa,"['Bone pain', 'Chills', 'Headache', 'Pyrexia', 'Sleep disorder']",UNK,MODERNA, 932015,IN,41.0,F,"Arm soreness (start: ~8 hrs post-vaccination, duration: 4 days) Fever & Chills (start: ~14 hrs post-vac, duration: 1.5 days) Fatigue (start: ~24 hrs post-vac, duration: 1 day) Joint & Muscle pain (start : ~24 hrs post-vac, duration: 1 day) Headache (start ~24 hrs post-vac, duration: 8-12 hrs) Armpit/upper breast pain (start ~48 hrs post-vac, duration: 2 days)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Synthroid Losartan Duloxetine Vitamin D Multivitamin,COVID (tested positive 12/15/20),Obesity Hypertension Hypothyroidism,,Nonr,"['Arthralgia', 'Axillary pain', 'Breast pain', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 932016,OH,68.0,F,"01/06/2021 0900, feeling tired, resting heart rate 94 to 110, normal resting heart rate 74 to 86. A few abnormal heart beats throughout the day....9 PM cardiac arrhythmia , multiple abnormal beats, irregular rhythm lasting for about 1 to 1 1/2 hours. went into a regular heart rhythm. never happened to me before! 01/07. am very tired, heart rate still 90 to low 100's a few abnormal beats throughout day, 01/08 am very tired a few abnormal beats, 3 episodes of abnormal beats and irregular heart rate. 01/09 am heart rate 74to 82 no abnormal heart beats and I feel fine now 10:30 pm feel this events are side effects from Covid Vaccine, afraid to get 2nd dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/06/2021,2.0,PVT,"Venlafaxine, Levothyroxine, Pantoprazole, Atorvastatin, Multiple Vitamin",None,None,,None,"['Arrhythmia', 'Fatigue', 'Heart rate irregular']",UNK,MODERNA,IM 932017,IN,62.0,F,"Headaches, hot flushes, and vital changes She experienced headaches and hot flushes right after vaccination Her BP went up to 164/72 (baseline BP 120/80), and HR up to 103 She stated she felt anxious while answering questions. HR down to 80 , but BP stayed high (160/70) in about 15 minutes Provider at the observation room checked her, instructed to continue to check vitals for the next couple of days, and let her leave. She was sent home.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,OTH,,,,,,"['Anxiety', 'Headache', 'Heart rate increased', 'Hot flush', 'Hypertension', 'Immediate post-injection reaction']",1,MODERNA,IM 932018,NY,36.0,F,macular popular rash at injection site with mild itching. 30 minutes of dizziness. Resolved. Happened approx 1 hr post vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,"Symbicort, Singulair, ventolin",,Asthma,,None,"['Dizziness', 'Injection site pruritus', 'Injection site rash', 'Rash maculo-papular']",UNK,MODERNA,IM 932019,MI,58.0,F,"Head ache with pressure/pain on top of head on 01/8/2021, woke 01/09/21 with nausea, progressed to headache and nausea so bad that I couldn't take migraine meds for fear of vomiting. Went to bed with chills. Woke with pain and stiffness in right shoulder joint. Nausea subsided and I took 50 mg immitrex. Could no longer lay down due to head pain, so slept sitting up two hours. Chills continued. Meds finally worked and headache subsided. Chills subsided. Mild nausea persists this evening.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Glucosamine and chondroitin, magnesium, marshmallow root, probiotics, L-glutamine, vitamin C, grapeseed extract Immitrex as needed for migraine","Auto immune- Menier's Disease (in remission several years, follow a low sodium diet), interstitial cystitis (also auto immune, started March 2020), migraines since age 20.","Migraines, IC, Menier's Disease, endometriosis, infertility",,"Soy, gluten and dairy sensitive, sulfa","['Arthralgia', 'Chills', 'Head discomfort', 'Headache', 'Musculoskeletal stiffness', 'Nausea']",1,PFIZER\BIONTECH,SYR 932020,WI,28.0,F,"Approximately 4 hours after the vaccine administration, I started getting symptoms that started mild and became severe including: headache, dry cough with chest pressure, dizziness/lightheaded, joint pain, body aches, fatigue, and chills. At 5:30 pm I started getting a fever, that started at 100.5 then increased to 103.3 by 8:30 pm. I was also nauseous and vomited once. I was tested the next morning for influenza and COVID and was negative. My fever came back down to 98.8 around 12 pm the next day. Overall, symptoms lasted approximately 30 hours after the vaccine was administered. I was out of work the following day after the vaccine. Now, 2 days after the vaccine I am just mildly fatigued with a dry cough left.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Nitrofurantoin monohydrate,UTI,,,Amoxicillin,"['Arthralgia', 'Chest discomfort', 'Chills', 'Cough', 'Dizziness', 'Fatigue', 'Headache', 'Impaired work ability', 'Influenza virus test negative', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting']",1,PFIZER\BIONTECH,IM 932022,ID,53.0,F,"Fever up to 101.7, aches, arm sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,"Humalog, Lantis, Victoza, metformen, lisinopril, farxiga, omeprezole, baby aspirin, atorvastatin, multivitamin, emergency gummies, viactive",None,Diabetes,,Nka,"['Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 932023,IL,40.0,M,Rash and hives over night. Relieves the next morning after taking diphenhydramine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,PHM,,,,,,"['Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 932024,IN,38.0,F,"Fatigue, headache, body aches, fever, chills, runny nose",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Duloxetine,"Rheumatic fever, reactive arthritis, migraines, eczema, anxiety, depression, asthma",Same as above,,NKDA,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia', 'Rhinorrhoea']",1,MODERNA,IM 932025,TX,25.0,M,"Headache, red bumpy rash spread all over body. Took benadryl to try and help the rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Cefdinir, ibuprofen, prednisone",Ear infection,,,"Penicillin, sulfa, clindamycin","['Headache', 'Rash', 'Rash erythematous']",1,PFIZER\BIONTECH,IM 932026,MS,35.0,M,"MODERNA COVID-19 VACCINE EUA. Temp between 101 & 103.9 all evening with alternating Tylenol & Ibuprofen. Nauseated, shortness of breath are also being experienced.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,MIL,Lisinopril & Wellbutrin,,Hypertension,,NKA,"['Body temperature increased', 'Dyspnoea', 'Nausea']",UNK,MODERNA, 932027,TX,61.0,F,"About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left deltoid muscle felt completely numb; palms slightly flushed, felt as if heart rate slightly elevated, but not tachycardia. No rash, no hives, no difficulty breathing. Acute episode lasted about 20-30 minutes, then just felt a little off for 1.5 hours more, then back to normal. For next 34-48 hours-mild fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,"Toprol XL, Estradiol patch, Cetirizine, Aspirin 81mg, Flonase",None,Hypertension Seasonal allergies,,None,"['Anxiety', 'Fatigue', 'Feeling hot', 'Heart rate increased', 'Injection site hypoaesthesia']",1,PFIZER\BIONTECH,IM 932028,CA,27.0,F,Miscarriage at 6 weeks pregnant,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/20/2020,2.0,PVT,,,,,"Oats, scallops",['Abortion spontaneous'],1,PFIZER\BIONTECH, 932030,HI,58.0,F,"12-31-20: arm sore in shot area. Ibuprofen 1-1-21: stiff arm and can?t raise above shoulder, arm pain. Ibuprofen 1-2-21: Hives start on both elbows and both sides of body. Larger welts (photo). Itchy. 6am starts. 1-3-21: Same as above but hives getting smaller and itchy less. 1-3-21: lost appetite. Took zinc for next 2days. 1-4-21: lost appetite. M",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,SCH,"Latanoprost, multivitamin, magnesium",None,High cholesterol,,"Allergic to almonds and mangoes- throat swells Cat fur- watery eyes, sneezing","['Decreased appetite', 'Injection site pain', 'Joint range of motion decreased', 'Musculoskeletal stiffness', 'Pain in extremity', 'Pruritus', 'Urticaria']",1,MODERNA,SYR 932031,IL,53.0,F,"Significant burning with admin of first shot. Approx 3.5 hours after shot I could not move my arm at the shoulder. This was more than muscle soreness but being unfamiliar with Covid vaccine, I just rode it out. This lasted 2 days. Since then, my shoulder joint has not been the same with sl limited ROM and persistent pain. This improved signif over the 3 weeks until my 2nd Covid vaccine 1/7/21. This is what tipped me off that the first shot was not correct. #2 did not burn at all with administration or cause any limited ROM. Typical deltoid soreness sl more than a tetanus shot, and general ""flu like sxs"" that lasted < 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/17/2020,0.0,WRK,Vyvanse prn and Vitamin D daily,none,none,,none,"['Influenza like illness', 'Injection site pain', 'Mobility decreased', 'Myalgia']",UNK,PFIZER\BIONTECH, 932032,NJ,50.0,F,"Had the vaccine on 12/31 at around 9 am. Had pain at the injection site (left upper arm) and muscle aches for 2 days. On the 6th day (Jan 6) at night, left upper arm started hurting and had on and off chills throughout the night. on January 7, there was increased pain to left upper arm along with generalized muscle aches and low grade fever constant at 99.9 and 100 throughout the day. On January 8, decreased pain to left upper arm, no more generalized muscle aches, no fever but easily fatigued. However, injection site and surrounding area is reddened and warm and tender to touch. Incident reported to Occupational Health as well as had telehealth visit with PCP who recommended cephalexin 500 mg 2x daily for 7 days and to monitor size of redness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/06/2021,6.0,PVT,"valsartan 80 mg 1 tab in the morning, 2 tabs at night rosuvastatin 5 mg at bedtime 3x week Zyzal 5 mg at bedtime Vit C 1000 mg daily, multivitamins once daily, Zinc 50 mg, Vit D3 4000 mcg",none,"HTN, HLD",,none,"['Chills', 'Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 932034,CA,32.0,F,"15-20 minutes after injection, my left arm and the left side of my face went numb. Numbness intensified over the next 2-3 hours then subsided. Lack of taste was also noticed. The following day I woke up with tingling and numbness in my left jaw and slight drooping of left eye and left corner of mouth.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,OTH,Levothyroxine,Facial rash,Thyroid cancer Hypothyroidism Factor V liden High blood pressure,,No known allergies,"['Ageusia', 'Facial paralysis', 'Hypoaesthesia', 'Paraesthesia']",UNK,MODERNA,SYR 932035,FL,53.0,F,"Soreness at injection state for 2 days then went away. Day 8 had blister like area which later turned very itchy. I went to occupational health at work. They game me hydrocortisone cream 1%. 1/9/2021 I woke up to swollen red arm, warm to the touch. Reddened area grew outside of pen marked area. Began having tachycardia and an increase in blood pressure and headache. I made an appointment with online doctor who said to monitor BP and if higher seek medical attention. Got off phone and felt dizzy. Took my blood pressure again and it was much higher so I went to the ER. ER determined it was reaction to vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/08/2021,8.0,PVT,Verapamil,None,"Ovarian cancer, obesity",,PCN,"['Blister', 'Blood pressure increased', 'Blood test', 'Chest X-ray', 'Computerised tomogram head', 'Dizziness', 'Electrocardiogram', 'Erythema', 'Headache', 'Injection site pain', 'Peripheral swelling', 'Pruritus', 'Skin warm', 'Tachycardia']",1,MODERNA,SYR 932036,MS,25.0,M,"Approximately 8 hours post injection, pt had fever, severe L deltoid pain, malaise, headache. Lasted for 12 hours. Pain decreases each day. Injection site pain still present somewhat day 3.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Singulair,None,None,,Nka,"['Headache', 'Injection site pain', 'Malaise', 'Pyrexia']",1,MODERNA,IM 932037,NC,53.0,F,Swelling on my neck shoulder axillary and chest on same side as injection site along with swelling and pain at the injection site And under my arm. I have also had insomnia.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,MIL,"Estradiol, pantoprazole",None,"Gastroparesis, ranauds",,None,"['Axillary pain', 'Injection site pain', 'Injection site swelling', 'Insomnia', 'Lymphadenopathy', 'Swelling']",2,PFIZER\BIONTECH,IM 932038,NC,29.0,F,"Severe body aches, chills, mild nausea, malaise? I took 3 ibuprofen and 1 extra strength Tylenol to alleviate symptoms, and went to sleep around 2pm, woke up for dinner and a shower and went back to sleep through the night",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,Omeprazole Zyrtec,,I BS,,,"['Chills', 'Hypersomnia', 'Malaise', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 932040,OR,48.0,F,"Pt. reported feeling racing heart rate. "" then I could feel blood pressure increase. But I think I was a bit unsettled by my racing heart. It was like an adrenaline jolt. Fight or flight for no reason. I was feeling pretty normal before that. Just checking my phone waiting for my 15 minutes to pass so I could go home. ""No shortness of breath, hives, or rash. 25 mg Benadryl PO administered. 1730 vitals: Sat 100% HR 135 BP 151/104 1733 Vitals: 151/98 Sat 100% HR 120 1735 Vitals: Sat 100% HR 111 1737 Vitals: Sat 100% HR 105 1745 Vitals: HR 106 Sat 99% 1754 vitals: HR 96 Sat 99% 1801: HR 94 Sat 99% Left 1830 or slightly after. Called ride to take her home. Feeling better when leaving",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Lexapro Multivitamin Vitamin D,None,None,,Sulfa Possible Sulfa allergy Food allergies: some tree nuts,"['Feeling abnormal', 'Palpitations']",1,MODERNA,IM 932041,MD,45.0,F,Uncontrollable pain in previous surgical sites and other sites of arthritis; not controlled with NSAIDs; muscle spasms x 5-6 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,"Synthroid, Wellbutrin, sertraline, Vit D.",none,Chronic low back s/p L5/S1 laminectomy/discectomy Chronic bilateral hip pain s/p arthroscopy L hip Hashimoto's thyroiditis,immediate swelling of entire arm and shoulder after Anthrax Vaccines,"Latex, seldane, hismanol","['Arthralgia', 'Muscle spasms', 'Procedural pain']",1,MODERNA,IM 932042,OR,41.0,F,"Had chill soon after the injection and about 5 minutes later had slight nausea, I was told to stay 15 more minutes for observation . About 30 minutes or so after the injection, I had sever nausea. The person at the observation sent me to ER for close monitoring . After couple hours of sever nausea My body started itchy for few hours without hives. In ER, prescribed zofran but didn?t take it. Stayed ER for few hours and I was released",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"Caberoline 0.5mg, vitamin d, vitamin c, vitamin e, prenatal, calcium, coq 10, omega 3, TruNiagen 300mg, Pterostilbene 150 mg",Na,Na,,"Isoniazid, bee sting","['Chills', 'Laboratory test', 'Nausea', 'Pregnancy test', 'Pruritus']",UNK,PFIZER\BIONTECH,IM 932043,PA,25.0,F,Severe pain at injection site Extreme tiredness,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,PVT,Metropolol Levothyroxine Omeprazole Ativan,Na,SVT Hypothyroidism Colitis,,Sulfa Cipro Bananas Shellfish,"['Fatigue', 'Injection site pain']",1,MODERNA,IM 932044,MI,36.0,F,"Approx one week post, started having red rash/blistering on lips. Within days it progressed around my whole mouth, lips, nose and cheeks. With swelling in the lips, mouth and cheeks.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,PVT,"Lexapro, Allegra, Protonix",Sinus infection 3 weeks prior,"Asthma, Anxiety, GERD, EOE",,"Penicillin, Sulfa drugs, coconut, celery, peas, shellfish. Mold","['Blister', 'Lip blister', 'Oral mucosal blistering', 'Rash erythematous']",1,MODERNA,IM 932045,NY,52.0,F,"Slightly more than 48 hours after receiving the 1st injection, the back of my neck and up into my hair, my upper shoulders, behind my ears and my chest started to itch. Hydrocortisone cream (1%) didn?t help much. Neither did an antihistamine tablet (loratadine.) More than 24 hrs after it started, it has gotten better, but not gone away.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,PUB,"Vyvanse (ADD,) Topiramate, ibuprofen, Zolpidem, citalopram, multivitamin, joint supplement",None,"ADD, degenerative disc disease/curved spine, chronic pain",,None,['Pruritus'],1,MODERNA,SYR 932046,CA,44.0,F,"Injection site and entire arm soreness x 48 hrs Nausea x 3 days Chills x 2 days Sore throat x 2 days Severe headache x 2 days (OTC Ibuprofen 600mg Q6-8 hrs, OTC Acetaminophen 1000mg x 1 dose) Mild headache x 1 day (OTC Ibuprofen 400mg PRN) Dizziness x 2 days (Ensured proper hydration) Body aches x 3 days (OTC Ibuprofen 600mg Q6-8 hrs, OTC Acetaminophen 1000mg x 1 dose) Malaise x 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Bupropion XL 300mg Bupropion SR 100mg Escitalopram 20mg Buspirone 7.5mg,None,Scoliosis Depression,,None,"['Chills', 'Dizziness', 'Headache', 'Injection site pain', 'Malaise', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 932047,KY,28.0,F,"Fever (100.7 F), chills, headache, muscle pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,None,COVID-19 on or around 12/26/20,None,,None,"['Chills', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 932048,CA,36.0,F,"First dose vaccine administered third trimester pregnancy. Local soreness evening after vaccine that worsened the next day but asymptomatic by 2 days post-vaccine. 7-8 days later, experienced itching and wheal/redness at injection site. Mild itchiness only persists 2 days later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,PVT,,,,,,"['Exposure during pregnancy', 'Injection site erythema', 'Injection site pruritus', 'Injection site urticaria', 'Pain']",1,MODERNA,IM 932049,OH,36.0,F,Eight days after vaccination. I developed hives around the injection site. Sore lymph node under right armpit. Tingling and numbness and bilateral legs,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,Multivitamin. Vitamin D 3. Biotin with zinc. Vitamin C. NuvaRing,No,No,,None,"['Full blood count', 'Hypoaesthesia', 'Injection site urticaria', 'Lymph node pain', 'Metabolic function test', 'Paraesthesia', 'Troponin', 'Ultrasound scan']",1,MODERNA,IM 932050,NY,63.0,M,"Body aches, fatigue, night sweats.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,"Levothyroxine, Lipitor, lamictal, Antabuse, Prozac, losarten, Metformin, Silodosin,clopidogrel, metropolol,",N/a,"High blood pressure & cholesterol Heart stent, obesity, bipolar , hypothyroidism",,Na,"['Fatigue', 'Night sweats', 'Pain']",1,MODERNA,IM 932051,MT,64.0,F,"Neuropathy left cheek, radiating up and down my face. It started in the late afternoon after I received the vaccination. It would get more intense throughout the day. I thought I was having a stroke. After sleeping it wasn't as intense, the more active I was it would intensify. I went to clinic on 1-07-2021 because I still have neuropathy on my left side of my face. The Provider tested me to see if I had Bells Palsy. He said I didn't, he recommended I see a Dentist, he thought I probably had a tooth infection. I went to the Dentist at 3 p.m. on 1-07-21. They took a panoramic x-ray of my teeth. The dentist adivsed me that I did not have a infected tooth. I limited my activity for the jrest of the day on 1-7-21. I still have the neuropathy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PUB,"Gabapentin 1,200 mg per day, Fluoxetine 30 mg per day, Amitriptyline 150 mg at night, Tramadol 100 mg as needed for pain, 5000 mcg vitamin D3 daily, 1000 mg Fish Oil per day, Citracal calcium supplement 2 per day, Melatonin 10 mg per night","Anxiety, depression.","Fibromyalgia, depression, chronic Sinusitis. I had the third fusion of my lumbar spine L2 - L5 on 10-26-2020. I received my third concussion on November 2, 2020.",,Sulfa,"['Neuropathy peripheral', 'X-ray dental normal']",UNK,MODERNA, 932052,NC,44.0,M,"Achey joints & muscles, fatigue, diarrhea, chills, sweats, headaches, sore left arm (injection side more sore than rest of sore body), pain & edema at injection site limiting shoulder range of motion for two days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,None,None,None,,None,"['Arthralgia', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Injection site swelling', 'Mobility decreased', 'Myalgia']",2,PFIZER\BIONTECH,IM 932053,LA,62.0,F,"Fever, chills, muscle aches, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Premarin, Preservision",None,None,"Shingles - fever chills,",NKA,"['Chills', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932054,MO,21.0,F,All day I?ve felt dizzy and I feel feverish and generally sick. When I stand up too fast I feel like I?m gonna pass out,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Mirena iud and 400 mg of ibuprofen 30 minutes before vaccination,"I was sick with cough, fatigue, headache, stuffy nose, body aches 1 week before but I got a covid test and it was negative",None,,Allergy to mangoes,"['Dizziness', 'Malaise', 'Pyrexia', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 932055,IL,35.0,M,Left armpit pain/swelling and upper arm muscle pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/03/2021,4.0,PVT,Fish oil,None,Mild Asthma,,None,"['Axillary pain', 'Myalgia', 'Swelling']",1,MODERNA,IM 932057,AZ,36.0,F,Raised red circle around injections site. 2 inches across by 1 3/4 inch long. First noticed this evening while changing.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/09/2021,10.0,PVT,Birth control,None,,,Demerol causes hives,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,SYR 932058,NV,41.0,F,Nerve pain L face/head 9/10 pain gradual improvement over 7 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/22/2020,3.0,WRK,Escilopram Lisinopril,None,"HTN, Depression, Anxiety",,None,"['Facial pain', 'Neuralgia']",1,PFIZER\BIONTECH,IM 932059,LA,49.0,M,"Dizziness started within 30 minutes after injection on 01/08/21 and felt ""off"". On 01/09/21 approx. 0800 Patient began feeling body aches, fevers, injection site pain, increased dizziness, and nausea. At approximately 1pm patient began vomiting and having diarrhea. Symptoms worsened over the next couple hours to where patient was unable to walk without stumbling. Wife witnessed patient becoming very pale and almost pass out at approx. 5:30pm. Patient states he feels like he's in slow motion. Patient is unable to maintain balance when walking and reports increasing fatigue and weakness.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/08/2021,01/09/2021,1.0,OTH,"amlodipine, losartan, Naprosyn, metoprolol succinate, adipex-p, Topamax, testosterone, zinc gluconate, anastrozole, omeprazole",none,hypertension,,KNDA,"['Asthenia', 'Balance disorder', 'Diarrhoea', 'Dizziness', 'Electrocardiogram abnormal', 'Fatigue', 'Feeling abnormal', 'Full blood count normal', 'Gait disturbance', 'Influenza virus test', 'Influenza virus test negative', 'Injection site pain', 'Metabolic function test', 'Metabolic function test normal', 'Nausea', 'Pain', 'Pallor', 'Presyncope', 'Pyrexia', 'SARS-CoV-2 test negative', 'Sensory disturbance', 'Troponin normal', 'Ventricular extrasystoles', 'Vomiting']",1,MODERNA,IM 932060,VA,33.0,F,Very bad injection site pain Lymph nodes pain Muscle pain Very blurry eyes,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PUB,Wellbutrin 300mg daily,,Depression,,Prozac Lactose intolerance,"['Injection site pain', 'Lymph node pain', 'Myalgia', 'Vision blurred']",1,MODERNA,IM 932147,KY,32.0,F,"Complained of a metalic taste minute after injection. Then felt jaw tightening and then felt tingling and dizzy feeling, nauseous, jittery. Bp 140/86 Hr 95. 12:40pm had Benadryl 50mg. 1:35pm left for ER with her husband.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,OTH,unknown,none,hx thyroid Cancer 4 years ago,,none,"['Dizziness', 'Dysgeusia', 'Feeling jittery', 'Muscle tightness', 'Nausea', 'Paraesthesia']",1,MODERNA,IM 932238,,73.0,F,"Headache, Myalgia, Fever, NauseaVomiting, Chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 951289,,41.0,F,"NauseaVomiting, HYPERtension & HYPERglycemia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Hyperglycaemia', 'Hypertension', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,ID 951290,,31.0,M,"Rash, UrticariaPruritus, Rash above left deltoid and forearm, nervous, diaphoretic",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Hyperhidrosis', 'Injection site rash', 'Nervousness', 'Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 951291,,40.0,F,"Tachycardia ""scratchy throat, fuzzy feeling tongue neck beginning to swell"" Narrative: monitored for 4 hours and discharged to home with epi pen,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Paraesthesia oral', 'Swelling', 'Tachycardia', 'Throat irritation']",1,MODERNA,IM 951518,WY,77.0,M,"Narrative: Patient with severe aphasia and only able to say ""hey, hey, hey"" or ""uh huh"" or shake his head no as a way to communicate. Patient previously able to ambulate with significant limp and hyperextension of right knee, but mostly wheelchair bound over last several years as he had had a slow and steady decline in overall health and mobility. Patient developed aggressive behavior of shouting ""hey"" and grabbing of groin in 2016. This was worked up with CT scans, labs, referral to urology, neurology, and referrals to psychiatry. The exact etiology of this action was never able to be affirmed, but thought to be more psychiatrically related. It improved significantly with addition of antipsychotics, worsened when antipsychotics were reduced, and improved again with addition of injectable antipsychotic on 12-10-2020.Patient suffered from falls on occasion given his significantly impaired physical mobility. His last documented fall was 8-31-2019. Patient began utilizing wheelchair most of time following that fall. No significant injuries noted in documentation of the falls. In the last 3 months, patient would often refuse medications. He would sometimes indicate that they would cause dizziness, and other times he would simply refuse. We attempted to hide medications in his food/fluid (with wife's blessing) and when he detected this he would occasionally refuse to eat. Patient previously on DOAC. After pharmacy review in 12/2020 it was recommended to discontinue this as no clear indication to continue use. He was high fall risk and would often refuse this medication as well since 10/2020. Noted to be in NSR on EKGs and decision made to discontinue the DOAC. Patient had no evidence of adverse effects noted after vaccination on December 28th. Patient seen by provider on the morning of his death (1/4/2021) with no noticeable significant change in health condition. Temperature 36.8Con January 4th at 19:45. During routine bedtime cares, patient suddenly collapsed and death was pronounced January 4, 2021 at 20:05. Autopsy was requested from next of kin and no autopsy was granted. Symptoms: & DEATH Treatment:",Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/04/2021,7.0,OTH,,,,,,"['Death', 'SARS-CoV-2 test negative', 'Syncope']",2,MODERNA, 951519,MN,78.0,M,"Narrative: Symptoms: Palpitations & Syncope Treatment: EPINEPHRINE 1 MG ONCE ,EPINEPHRINE 1 MG ONCE ,SODIUM BICARBONATE 50 ML ONCE",Yes,01/05/2021,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Palpitations', 'Syncope']",2,PFIZER\BIONTECH, 952836,,52.0,F,"HYPERtension throat tightness, paresthesias in extremities, muscle spasms Narrative: Shortly after receiving the vaccine she felt uneasy and experienced the sensation of throat tightness and numbness and tingling in hands and feet, also some rigidity/clonus in the hands. No rash, no wheezing, O2 sat 99%+. The team at the vaccination clinic checked her vital signs and her systolic BP was elevated to 220's. A rapid response was called and she was taken to the emergency room. In the emergency room, she received a neurology consult and head CT to rule out hypertensive bleeding. The scan was negative. She was given labetalol 10mg IV to lower BP, and also solumedrol 125mg, benadryl 25mg. No epinephrine given. Serum potassium was found to be low as well; given oral potassium repletion. Discharged from ER by noon same day, BP down to 160/79.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Blood potassium decreased', 'Blood pressure increased', 'Clonus', 'Computerised tomogram head normal', 'Feeling abnormal', 'Hypertension', 'Muscle spasms', 'Paraesthesia', 'Throat tightness']",1,PFIZER\BIONTECH,IM 952903,,47.0,F,Dizziness & Angina Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Angina pectoris', 'Dizziness']",1,PFIZER\BIONTECH,IM 953029,,56.0,M,Arthralgia & Fever Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Arthralgia', 'Pyrexia']",1,MODERNA,IM 953039,,31.0,F,"Arthralgia, NauseaVomiting & HYPOtension Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Arthralgia', 'Hypotension', 'Nausea', 'Vomiting']",1,MODERNA,IM 953049,,30.0,M,"Arthralgia, Fever, NauseaVomiting ,dyspnea Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Arthralgia', 'Dyspnoea', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 953060,,59.0,F,Palpitations Narrative,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,['Palpitations'],1,MODERNA,IM 953068,,46.0,F,Angioedema Narrative: Employee presented to ER for right sided facial swelling 9 days following PFIZER injection. Employee did not experience any SOB or chest pain. ER provider administered steroid injection for treatment. Employee returned to work on the day of discharge and states she will follow up with private allergist for further disposition.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/28/2020,9.0,OTH,,,,,,"['Angioedema', 'Swelling face']",1,PFIZER\BIONTECH,IM 953071,,64.0,F,Dizziness Narrative: Employee had waited her 15 minutes and left the room. Came back to room and stated she felt dizzy. Vital signs taken and stable. Pt taken to ER for further evaluation.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/30/2020,,OTH,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 953076,,38.0,F,Dizziness & Tachycardia Narrative: Participant C/O dizziness upon ambulation shortly after completing a 15 minute observation period. Noted tachycardia with a heart rate of 137. Pt transported VIA wheelchair to the Emergency room triage area for further evaluation.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Dizziness', 'Tachycardia']",1,PFIZER\BIONTECH,IM 953192,,1.75,M,"Headache, Fever & Tachycardia Narrative: Prior diagnosis of Covid-19 on 12-10-20. Reports having a headache when she received the vaccine. Later that evening her headache intensified into a migraine with blurred vision, left ear tinnitus the loss of hearing in left ear. She also reports tachycardia and temp of 100.2. She reports being treated with 2L NS, Torodal, solumedrol, and Ketamine. Treated at another facility, exact doses unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Deafness unilateral', 'Headache', 'Migraine', 'Pyrexia', 'Tachycardia', 'Tinnitus', 'Vision blurred']",1,MODERNA,IM 954113,,64.0,M,Dizziness & Headache Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,OTH,,,,,,"['Dizziness', 'Headache']",1,PFIZER\BIONTECH,IM 954121,,50.0,F,TIAStoke Employee complained of numbness at injection and stated she would like to wait about 5 minutes to see if it got better. Employee then stated it started to travel down right arm. Employee was offered treatment and was taken to be evaluated. Employee complained of numbness at injection and stated she would like to wait about 5 minutes to see if it got better. Employee then stated it started to travel down right arm. Employee was offered treatment and was taken to be evaluated.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,,01/06/2021,,OTH,,,,,,"['Cerebrovascular accident', 'Hypoaesthesia', 'Injection site hypoaesthesia', 'Transient ischaemic attack']",1,MODERNA,IM 954128,,36.0,F,"UrticariaPruritus Mild throat constriction, peri-orbital swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Periorbital swelling', 'Pruritus', 'Throat tightness', 'Urticaria']",1,MODERNA,IM 954133,,30.0,F,"SkinRash Narrative: Pt treated with Mehtylprednisolone 125mg IV, Diphenhydramine 50mg IV, Famotidine 20mg IV",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,['Rash'],1,MODERNA,IM 954138,,32.0,F,"Dizziness, Headache, SkinRash, NauseaVomiting, palpitations, metallic taste instantly after injection Narrative: When injection, the patient immediately tasted a metallic taste, tingling down left arm, headache, flushing, nauseated, numbness and tingling in hands and feet, chest pain- described as palpitations.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Chest pain', 'Dizziness', 'Dysgeusia', 'Flushing', 'Headache', 'Hypoaesthesia', 'Immediate post-injection reaction', 'Injection site paraesthesia', 'Nausea', 'Palpitations', 'Paraesthesia', 'Rash', 'Vomiting']",1,MODERNA,IM 954145,,35.0,F,Rash rash on chest/chest tightness Narrative: The patient required benadryl and monitoring in the emergency department for further allergic reaction. The patient required prescription for prednisone and benadryl at time of her discharge. The patient required a second visit to an urgent care due to mouth ulcers on 1/4/21,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/31/2020,3.0,OTH,,,,,,"['Chest discomfort', 'Mouth ulceration', 'Rash']",1,MODERNA,IM 954153,,59.0,F,Palpitations,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,OTH,,,,,,['Palpitations'],1,MODERNA,IM 954160,,37.0,F,"Anaphylaxis severe anaphylaxis; SOB, stridor Narrative: Patient has multiple allergies including severe anaphylaxis to peanuts and a reaction to a previous flu vaccine. Patient desired COVID vaccination and was cleared by private PC to receive vaccine from Employee Health. Patient had with her her own Epi-pen and albuterol inhaler. Patient was administered vaccine and observed in the observation area. Approximately 14 minutes after vaccination physician in observation area responded to patient with stridor and code white was called. Code team responded to vaccination testing site. Upon arrival, patient seated and alert sitting using albuterol inhaler. BP 160/93, HR 97, 99% room air. She was tachypneic and in respiratory distress following the first dose of her COVID 19 vaccine. Patient gave herself OT of EPI, and then our on call team arrived. Upon arrival as noted above, she was using her albuterol inhaler, 12.5mg benadryl attempted to be given however patient with difficulty swallowing. She was taken to ED and on way 2nd dose of epinephrine given. Patient was stabilized. Follow-up: Take Prednisone for 3-5 days. Take an antihistamine like Benadryl or Zyrtec for the next 3-5 days. Also take Pepcid 20 mg 2 times daily for the next 3-5 days. Return for worsening reaction. Timeline of event: Situation: 1001 Pt was given her first Covid vaccine, staff was watching her time and at 1014 it was noticed that she was not breathing well. 1015 Code white called. 1015 Pt gave herself and dose of Epi, 1018 pt took own inhaler,1019 Benadryl 12.5 given. 1021 pt to ED for evaluation, on the way 2nd dose of Epi given- 1025 1030=pt was acode white from the area from where getting covid vaccine shots, pt states received shot at 1001 this am and with in 30 min she began to feel SOB, when pt arrived to ER respirations of stridor. pt spo2 at 99% on room air. 1045-pt has had a 20g placed by Rn in lt ac with blood draw, pt has been placed on monitor. VS WN. 1055- pt has received pepcid 20mg IV in 50ml to run over 30 min. sol-medrol 125ng ivp benadryl 50mg ivp 1100- pt now resting with warm blanket pt no longer having stridor. upper resp clear. pt spo2 at 99% ON ROOM AIR. will continue to monitor. 1120- pt states she feels much better. 1200-pt still sleeping in room. 1225- pt has been D/c to home with instructions from provider.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,yes- patient stated she had an anaphylactic reaction previously to an influenza vaccine (unknown when or brand),,"['Anaphylactic reaction', 'Blood test', 'Dysphagia', 'Dyspnoea', 'Respiratory distress', 'Stridor', 'Tachypnoea']",1,MODERNA,IM 954161,,8.0,F,"RespDepression, Palpitations & Tachycardia Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Palpitations', 'Respiratory depression', 'Tachycardia']",UNK,MODERNA,IM 954162,,59.0,F,"BlurredVision, Dizziness, Palpitations, Tachycardia, ""throat tightening"" Narrative: Patient with tachycardia, dizziness, blurred vision and throat tightening. Evaluated in ED. Benadryl IV",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Dizziness', 'Palpitations', 'Tachycardia', 'Throat tightness', 'Vision blurred']",1,MODERNA,IM 956882,,76.0,M,Narrative:,Not Reported,,Not Reported,Yes,,Not Reported,U,11/30/2020,12/04/2020,4.0,OTH,,,,,,['Unevaluable event'],1,UNKNOWN MANUFACTURER, 956897,,42.0,F,"Dizziness, Headache, Myalgia, Tachypnea, CoughWheeze, NauseaVomiting, Palpitations & Tachycardia & Narrative: Patient stated that after receiving injection on 01/06/2021, tasted metal in her mouth. No reaction noted in clinic after vaccine administered. Patient states that after returning home, she began to have chills, headache, and muscle aches. Could not sleep. On 01/07/2021. Patient continued to experience above symptoms. Approx. 13:50 on 01/07/2021. Patient presented with respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was tachycardic. Epi-pen administered via left lateral thigh. Patient administered 50mg of PO Benadryl, and 2 puffs of albuterol inhaler. Continuous V/S initiated. Patient began to experience relief of symptoms. HR and blood pressure remained elevated, but this was expected side effect of epi. SpO2 stabilized around 99% on room air. Patient was monitored for 60 minutes. Transportation home was arranged and family was present to observe overnight.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,,,,,,"['Blood pressure increased', 'Chills', 'Cough', 'Dizziness', 'Dysgeusia', 'Dyspnoea', 'Headache', 'Heart rate increased', 'Insomnia', 'Myalgia', 'Nausea', 'Obstructive airways disorder', 'Palpitations', 'Stridor', 'Tachycardia', 'Tachypnoea', 'Vomiting', 'Wheezing']",1,MODERNA,IM 956903,,86.0,M,"mi Narrative: patient with asymptomatic covid 19, covid positive 12/10/2020.",Yes,12/27/2020,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/27/2020,5.0,OTH,,,,,,"['Asymptomatic COVID-19', 'SARS-CoV-2 test positive']",1,MODERNA,IM 956966,,86.0,M,"hypoxia, secretions,cough, dyspnea Narrative: ALS patient on hospice with ongoing history of aspiration pna, receiving tube feeds. Developed incr in secretions, hypoxeia, temp and with recently noted clogged feeding tube.",Yes,12/25/2020,Not Reported,Not Reported,,Not Reported,N,12/25/2020,12/25/2020,0.0,OTH,,,,,,"['Body temperature increased', 'Complication associated with device', 'Cough', 'Dyspnoea', 'Hypoxia', 'Secretion discharge']",1,MODERNA,IM 956978,,80.0,M,"pneumonia Narrative: On 11/9/20, Patient had a presumptive positive COVID (COBAS) screen as part of routine CLC screening and then on 11/13/20, he had a repeat COVID (CEPHID) that was negative. Then on 12/22/20, he received his first COVID vaccine. On 12/26/20, he began to have c/o hurting all over. Noted history of aspiration and COPD. On 12/29/20, he began to have coughing, increased shortness of breath and runny nose with course breath sounds in his bilateral lower lobes. A chest xray was done and he was initiated on oral azithromycin and cefepime for a bilateral pneumonia. On 1/3/21, he continued to decline with increasing shortness of breath and was subsequently transferred to acute care medicine. All COVID tests have been negative since the presumptive positive on 11/9/20. He did have a CTA that ruled out PE but did show bilateral pneumonia. His antibiotics have been changed to meropenem, vancomycin and IV azithromycin. He remains on acute care at time and has not required ICU care.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/22/2020,12/29/2020,7.0,OTH,,,,,,"['Angiogram pulmonary abnormal', 'Breath sounds abnormal', 'Chest X-ray abnormal', 'Cough', 'Dyspnoea', 'Pain', 'Pneumonia', 'Rhinorrhoea']",1,MODERNA,IM 956991,,77.0,M,"COVID positive Narrative: Patient is a resident and received his first COVID vaccine on 12/28/20. On 1/4/21, he had a COVID routine screen done that returned positive on 1/6/21. Per notes, he was asymptomatic at the time; however for isolation purposes, he was transferred to acute care medicine services. On 1/7/21, he was noted to have a slight increase in BUN/creatinine ratio thought to be due to volume depletion and has been ordered IV fluids. He still remains free of any respiratory symptoms at this time.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/28/2020,01/04/2021,7.0,OTH,,,,,,"['Blood urea nitrogen/creatinine ratio increased', 'Hypovolaemia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 957037,,44.0,F,Diarrhea & NauseaVomiting Narrative:,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/23/2020,12/26/2020,3.0,OTH,,,,,,"['Diarrhoea', 'Nausea', 'Vomiting']",1,MODERNA,IM 964622,,67.0,F,Narrative:,Not Reported,,Yes,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Incorrect route of product administration'],1,PFIZER\BIONTECH,SC 964629,,64.0,M,"Death - Hospice patient with metastatic CA admitted to facility and received vaccine during stay. No adverse sequelae noted from vaccine administration, but reporting as required because pt died 7 days later. Narrative: Reporting this event because patient died 7 days after receiving vaccine in the facility where he was in hospice care for metastatic cancer. Vaccine was administered by protocol without complications. The patient had been asked and denied any prior severe reaction to this vaccine or its components and gave permission to receive it. No vaccine adverse sequelae were documented after the immunization as monitored for 15 minutes nor in facility notes for 7 days after the immunization. The patient's death was felt to be due to underlying terminal illness.",Yes,12/27/2020,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/27/2020,10.0,OTH,,,,,,"['Death', 'Terminal state']",1,PFIZER\BIONTECH,IM 964636,,81.0,M,"Pt on hospice in facility for severe cardiomyopathy unable to perform interventions received vaccine without adverse sequelae died 5 days later. Reporting as required. Narrative: Reporting as required patient death 5 days after immunization with Pfizer vaccine. However, no adverse sequelae were noted to the vaccine in the 15minute observation period, nor in the days following the immunization related to the vaccine. The patient denied any prior severe reaction to this vaccine or its components, and the patient gave verbal consent to receive the vaccine. Patient had been in the facility on hospice since 11/18/20 for severe decompensated HF and newly diagnosed cardiomyopathy, unable to perform interventions, also LE ischemic wounds with very poor potential to heal due to advanced PVD.",Yes,12/22/2020,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/22/2020,5.0,OTH,,,,,,['Death'],1,PFIZER\BIONTECH,IM 964641,,57.0,F,Narrative: Temporary restriction on driving until further evaluation due to symptoms of seizures.,Not Reported,,Not Reported,Yes,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Impaired driving ability', 'Seizure']",1,MODERNA,IM 977334,,64.0,M,"Myalgia, Diarrhea, pain at injection site Narrative: Myalgia and inection site pain/myalgia and diarrhea by 9pm on date of injection 12/29/20. Myalgias continued for 2 days and resolved by day 3.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/29/2020,,OTH,,,,,,"['Diarrhoea', 'Injection site pain', 'Myalgia']",1,PFIZER\BIONTECH,IM 977455,,58.0,M,Soreness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA,IM 977456,,57.0,F,"SkinRash, Rash, UrticariaPruritus, FAINT RASH TO RIGHT FOREARM AND RIGHT UPPER ARM, ITCHING TO LEFT ARM NO RASH Narrative: EMPLOYEE WAS EVALUATED BY EMPLOYEE HEALTH NP AND GIVEN BENADRYL 50 MG PO",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/05/2021,,OTH,,,,,,"['Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 977457,,53.0,F,"Headache, Myalgia, Fever, sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/05/2021,4.0,OTH,,,,,,"['Headache', 'Myalgia', 'Oropharyngeal pain', 'Pyrexia']",1,MODERNA,IM 977458,,47.0,F,"Headache, Myalgia, Fever, Swelling Narrative: Patient had body aches, fever, swelling at injection site on 12/3/20 and headache on 01/03/21. Used OTC benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Headache', 'Injection site swelling', 'Myalgia', 'Pain', 'Pyrexia']",1,MODERNA,IM 977459,,52.0,F,"Headache, fever, chills, night sweats, body aches Narrative: Side effects from day#2: soreness in arm headache fever (100.5F) body acghes chills night sweats all resolved by day#3",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/02/2021,1.0,OTH,,,,,,"['Chills', 'Headache', 'Night sweats', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 977460,,49.0,M,Headache Soreness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Headache', 'Injection site pain']",UNK,MODERNA,IM 977461,,48.0,F,"Nausea, Malaise Narrative: approx 1 hour after injection mild nausea and general malaise developed. nausea resolved in approx 4 hours malaise persisted, cervical and upper thoracic localized muscle pain began and persisted and fatigue worsened to impact daily activity. felt like ""mono""; persisted 48 hours before gradually resolving. additionally injection site pain and warmth for about 48 hours (no erythema or edema) Ibuprofen 400mg was take one hour prior to injection ; repeated 4 hours later then 600mg q6hours x 48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,OTH,,,,,,"['Back pain', 'Fatigue', 'Injection site pain', 'Injection site warmth', 'Loss of personal independence in daily activities', 'Malaise', 'Myalgia', 'Nausea', 'Neck pain']",1,MODERNA,IM 977462,,57.0,M,"Headache, NauseaVomiting, FATIGUE Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 977469,,43.0,F,"sore arm, redness, itching Narrative: soreness started day of injection redness and itching within a day later",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Erythema', 'Pain in extremity', 'Pruritus']",1,MODERNA,IM 977484,,30.0,F,"BlurredVision NauseaVomiting & Syncope Narrative: 15 minutes after vaccine was given, employee reported visual changes and nausea. Then she lost consciousness for several seconds while seated. Emergency response team was called, no treatment was provided except supportive care and ginger ale when she regained consciousness. She was placed on cardiac monitor and observed for 30 minutes, initial HR was in 50's sinus bradycardia and BP 102/62. No further issues after 30 mins of observation time and employee was released to return to work. Employee reported having a similar reaction after giving blood in past.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/05/2021,,OTH,,,,,,"['Loss of consciousness', 'Nausea', 'Syncope', 'Vision blurred', 'Vomiting']",1,PFIZER\BIONTECH,IM 977870,,62.0,F,"Sedation, Myalgia & Arthralgia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Arthralgia', 'Myalgia', 'Sedation']",1,MODERNA,IM 977884,,60.0,F,"Dizziness, NauseaVomiting, severe vertigo, vomiting and diarrhea, weakness Narrative: dizziness started approx 2 hours after vaccine was administered. that evening, experienced severe vertigo and weakness, vomiting and diarrhea and collapsed on the bathroom floor. took some benadryl. next day could not get out of bed due to dizziness and weakness. have since recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Asthenia', 'Diarrhoea', 'Dizziness', 'Mobility decreased', 'Nausea', 'Syncope', 'Vertigo', 'Vomiting']",1,MODERNA,IM 977893,,34.0,F,"Headache, Arthralgia, Fever, Fatigue, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Pyrexia']",1,MODERNA,IM 977904,,57.0,M,"Headache, Myalgia, Fatigue, stiffness in arm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Musculoskeletal stiffness', 'Myalgia']",1,PFIZER\BIONTECH,IM 977917,,65.0,M,Myalgia Soreness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Injection site pain', 'Myalgia']",UNK,MODERNA,IM 977937,,46.0,F,"Headache, NauseaVomiting, Sweats, dysphagia Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Dysphagia', 'Headache', 'Hyperhidrosis', 'Nausea', 'Vomiting']",1,MODERNA,IM 977958,,69.0,M,"Headache & Myalgia Narrative: Developed headache and severe muscle pain, could not sleep, lasted 36 hours, resolved spontaneously",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Headache', 'Insomnia', 'Myalgia']",1,MODERNA,IM 977968,,26.0,F,"Myalgia, Fever, Chills Narrative: Took OTC ibuprofen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 977972,,63.0,M,SORENESS AT INJECTION SITE,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA,IM 977986,,62.0,F,"Confusion, Headache, Myalgia, fatigue, chills Narrative: Felt ""loopy"" with sharp vision initially. Over 3 day period developed varying degrees of chills, headache, muscle aches. Fatigue on first day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Chills', 'Confusional state', 'Headache', 'Myalgia', 'Visual impairment']",1,PFIZER\BIONTECH,IM 977992,,53.0,M,"Myalgia, Fever, Severe pain at injection site (left deltoid), low-grade fever: 99.8F, muscle ache and joint pain. Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Arthralgia', 'Injection site pain', 'Myalgia', 'Pyrexia']",1,MODERNA, 977998,,53.0,M,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Headache'],UNK,MODERNA,IM 978005,,48.0,F,Phlebitis & UrticariaPruritus Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,OTH,,,,,,"['Phlebitis', 'Pruritus', 'Urticaria']",UNK,MODERNA,IM 978012,,65.0,M,Diarrhea & NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Diarrhoea', 'Nausea', 'Vomiting']",1,MODERNA,ID 978013,,40.0,F,Arthralgia fever Narrative,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,OTH,,,,,,"['Arthralgia', 'Pyrexia']",1,MODERNA,IM 978021,,35.0,F,"REDNESS AND ITCHING AT INJECTION SITE (APPROX 3 INCHES IN DIAMETER) Narrative: itching and redness, slightly raised in approx 3 in diameter of injection site (this began 8 days after injection)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,OTH,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 978027,,1.08,F,L sided Facial Numbness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Hypoaesthesia'],1,MODERNA,IM 978035,,53.0,M,"Headache, Myalgia, BODY ACHES, CHILLS Narrative: Reports that at approximate 0230 this morning developed headache, chills, body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/05/2021,,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Pain']",1,MODERNA,IM 978043,,63.0,F,"Angioedema Right eye swollen shut and tearing within 24 hours, now resolved Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Angioedema', 'Eye swelling', 'Lacrimation increased']",1,PFIZER\BIONTECH, 978048,,38.0,F,flu-like symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,OTH,,,,,,['Influenza like illness'],1,MODERNA,IM 978056,,56.0,M,Dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Dizziness'],1,MODERNA,IM 978062,,39.0,M,PAIN AT INJECTION SITE,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA,IM 978067,,63.0,M,Myalgia SPECIFICALLY STIFF NECK Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Musculoskeletal stiffness', 'Myalgia']",UNK,MODERNA,IM 978075,,28.0,F,Myalgia Fatigue for 48 hours; Subjective fever and chills; feeling of fogginess Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Feeling abnormal', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 978083,,47.0,M,"Dizziness, Seizures, Syncope, Bradycardia, cold, clammy Narrative: 10 mins after administration, Employee began expressing lightheadedness, Employee assessed, employee was cold and clammy. Employee then began to have a seizure which last approx 30 sec. Vital signs assessed BP 110/80 HR 87 then dropped to 50 which is unusual for employee. o2 sat 94% on room. Employee regained consciousness and was able to state name, time and place. Reported no previous history of seizures. Employee handed off to ER staff for further eval.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Bradycardia', 'Cold sweat', 'Dizziness', 'Heart rate decreased', 'Nasopharyngitis', 'Seizure']",1,PFIZER\BIONTECH,IM 978172,,41.0,F,Headache SEVERE MIGRAINE LASTED 24 HOURS Narrative: MIGRAINE THAT LASTED 24 HOURS. TOOK MIGRAINE MEDICATIONS BUT WOULD NOT SPECIFY WHICH ONES,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/28/2020,,OTH,,,,,,"['Headache', 'Migraine']",UNK,MODERNA,IM 978173,,47.0,F,On 12/30/2020 noticed lump under left arm pit. Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/30/2020,6.0,OTH,,,,,,['Axillary mass'],1,MODERNA,IM 978174,,55.0,F,Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Fatigue'],UNK,MODERNA,IM 978175,,60.0,F,FATIGUE AND SORENESS AT INJECTION SITE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Fatigue', 'Injection site pain']",UNK,MODERNA,IM 978176,,76.0,M,TENDERNESS AT INJECTION SITE. Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA,IM 978177,,44.0,F,Dizziness Narrative: transient lightheadedness 60 seconds or less,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/04/2021,,OTH,,,,,,['Dizziness'],UNK,PFIZER\BIONTECH, 978178,,50.0,M,Fatigue and soreness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Fatigue', 'Injection site pain']",UNK,MODERNA,IM 978180,,41.0,F,Chills and chest tightness; erythema at site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Chest discomfort', 'Chills', 'Injection site erythema']",1,MODERNA,IM 978183,,41.0,F,Sloughing nodule that released fluid and became healing lesion with granulation tissue,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,OTH,,,,,,"['Discharge', 'Excessive granulation tissue', 'Nodule', 'Skin exfoliation', 'Skin lesion']",1,MODERNA,IM 978184,,37.0,F,"Headache, UrticariaPruritus, Light sensitivity. Fatigue. Bounding headache. Injection site redness - silver dollar sized. Tender and warm. Narrative: Evaluated and cleared by Occ. Health on 12/30/20/ Historically, patient tested COVID positive in July. 1/6/21-Patient sent to Occ. Health today again. Redness increasing with induration. Hot to touch. Reports extreme itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Induration', 'Injection site erythema', 'Photophobia', 'Pruritus', 'Skin warm', 'Tenderness', 'Urticaria']",1,MODERNA,IM 978186,,49.0,F,"Dizziness Narrative: felt dazed, resolved in 7 minutes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Dizziness', 'Feeling abnormal']",1,MODERNA,IM 978189,,35.0,F,Rash Narrative: rash around injection site 7x7.5cm up to 8 days later,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Injection site rash'],1,MODERNA,IM 978190,,68.0,M,"Headache, NauseaVomiting & HYPERtension Narrative: after vaccine same day had nausea, headache, elevated BP, after 45 minutes felt better, went home to rest, had loose stools, better two days later",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Blood pressure increased', 'Diarrhoea', 'Headache', 'Hypertension', 'Nausea', 'Vomiting']",1,MODERNA,IM 978191,,31.0,F,"Dizziness, Fever, fatigue, redness and swelling at injection site, Narrative: off work x 1 day;",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Dizziness', 'Fatigue', 'Injection site erythema', 'Injection site swelling', 'Pyrexia']",1,PFIZER\BIONTECH,IM 978192,,41.0,M,"SkinRash, Rash, metalic taste in mouth Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Dysgeusia', 'Rash']",1,MODERNA,IM 978193,,57.0,F,SkinRash,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Rash'],1,MODERNA,IM 978194,,36.0,M,"Arthralgia, Fever & CoughWheeze Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,OTH,,,,,,"['Arthralgia', 'Cough', 'Pyrexia', 'Wheezing']",UNK,PFIZER\BIONTECH,IM 978195,,52.0,F,"Myalgia Left cervical lymphadenopathy, muscles feel weak. Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/28/2020,7.0,OTH,,,,,,"['Lymphadenopathy', 'Muscular weakness', 'Myalgia']",1,PFIZER\BIONTECH,IM 978196,,67.0,F,Fever Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/03/2021,1.0,OTH,,,,,,['Pyrexia'],UNK,PFIZER\BIONTECH, 981317,,38.0,F,"Headache, Myalgia, Fatigue Narrative: Received vaccine on 12-20-20. On 12-21, came to work but did not feel and so stayed home from work the following day 12-22. Now feeling better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/22/2020,2.0,OTH,,,,,,"['Fatigue', 'Headache', 'Impaired work ability', 'Myalgia']",1,PFIZER\BIONTECH,IM 981333,,35.0,F,"Headache, Fever & NauseaVomiting Narrative: Received vaccine in morning. By evening experiencing flu-like symptoms. Missed the next two days of work. Did not seek medical treatment. Managed low fever with tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,OTH,,,,,,"['Headache', 'Impaired work ability', 'Influenza like illness', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 981339,,58.0,F,"Headache, Myalgia, Fatigue Narrative: Received vaccine on 12-21-20. Came to work the next day, by noon was not feeling well. Headache, myalgia and fatigue. Left work at 2pm - which was 2 hours early. Slept it off, came to work the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Impaired work ability', 'Malaise', 'Myalgia']",1,PFIZER\BIONTECH,IM 981347,,54.0,F,"Headache, Myalgia, Fever, chills, soreness at injection site Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/02/2021,11.0,OTH,,,,,,"['Chills', 'Headache', 'Injection site pain', 'Myalgia', 'Pyrexia']",UNK,MODERNA, 981355,,24.0,F,Fatigue and enlarged lymph nodes,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/04/2021,12.0,OTH,,,,,,"['Fatigue', 'Lymphadenopathy']",UNK,MODERNA, 981370,,40.0,M,"SkinRash, Rash, UrticariaPruritus, rash near site of injection,tingly, numbness between shoulder blades intermittently continues 1/4/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/23/2020,,OTH,,,,,,"['Hypoaesthesia', 'Injection site rash', 'Paraesthesia', 'Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 981377,,49.0,M,"Headache tingling and numbness in R side down to toe's then whole body, HA on R side, felt better after standing up. stayed 30 minutes. Felt better and left. Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Headache', 'Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 981411,,61.0,F,SkinRash Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Rash'],1,MODERNA,IM 981433,,67.0,F,COVID-19 infection Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,OTH,,,,,,['COVID-19'],1,MODERNA,IM 981441,,62.0,F,tongue and central facial numbness resolved within 3 hrs Narrative: reports 3hrs of numbness but no medical f/u at time,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Hypoaesthesia', 'Hypoaesthesia oral']",1,MODERNA,IM 981447,,63.0,M,Headache Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,OTH,,,,,,['Headache'],UNK,MODERNA,IM 981457,,67.0,F,"UrticariaPruritus Narrative: not puritic , scattered and continuing to occur 6 days post",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Pruritus', 'Urticaria']",1,MODERNA,IM 981464,,66.0,F,"large swollen, raised, red area (approx.. 4"" X 3"") on my left upper arm Narrative: large swollen, raised, red area (approx.. 4"" X 3"") on my left upper arm. HAS IMPROVED",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,OTH,,,,,,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 981470,,46.0,F,"Dizziness, Headache, Myalgia, Arthralgia, Numbness at upper lip and pruritus all over the body Narrative: The above reported symptoms lasted longer than usual although the symptoms are improving. She still have some itching, fatigue, and lethargy on the 11th day of post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/26/2020,2.0,OTH,,,,,,"['Arthralgia', 'Dizziness', 'Fatigue', 'Headache', 'Hypoaesthesia oral', 'Lethargy', 'Myalgia', 'Pruritus']",1,MODERNA,IM 981477,,50.0,F,"Agitation, Tachypnea & CoughWheeze Narrative: Patient has HX of anaphylaxis with animal allergies and has not received the flu shot in many years because reactions (Arm Swelling ) were getting worse. Today after vaccine administration she stated that she was having problems breathing and became tachypneic and that she felt like her throat was closing. She wanted her home dose EPI pen. Doctor administered clinic EPI pen and symptoms resolved quickly. Vital were stable. 911 was called per protocol but patient refused going to ER for 6 hours of monitoring per protocol. form signed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/04/2021,,OTH,,,,,,"['Agitation', 'Cough', 'Dyspnoea', 'Tachypnoea', 'Throat tightness', 'Wheezing']",1,MODERNA,IM 981485,,,F,"Headache, SkinRash, Rash, shortness of breath, itching of neck and back, hives on neck and chest, headache, dry mouth. Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Dry mouth', 'Dyspnoea', 'Headache', 'Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 981494,,67.0,F,"Myalgia fever, fatigue Narrative: 2am this morning, symptoms started",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,OTH,,,,,,"['Fatigue', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 981500,,60.0,F,"Arthralgia chills, swollen glands, fatigue x 2 days;",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 981503,,49.0,F,"Angioedema, HYPERtension, Narrative: Lips swollen and hypertension. Lips less after 20 mins",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Angioedema', 'Hypertension', 'Lip swelling']",1,PFIZER\BIONTECH,IM 981504,,37.0,F,"Headache, Myalgia, malaise/fatigue, chills without fever Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Malaise', 'Myalgia']",UNK,PFIZER\BIONTECH, 981505,,47.0,F,Diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/31/2020,4.0,OTH,,,,,,['Diarrhoea'],1,MODERNA,IM 981506,,50.0,M,"Rash Narrative: Patient had COVID-19 approximately 60 days prior to vaccination. Day after vaccination, had chills that resolved with acetaminophen then a rash the following day that resolved one day later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,OTH,,,,,,"['Chills', 'Rash']",1,MODERNA,IM 981507,,54.0,M,"Sedation, Arthralgia & Fever Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Arthralgia', 'Pyrexia', 'Sedation']",1,MODERNA,IM 981508,,63.0,M,Myalgia & Diarrhea Narrative: Patient received the vaccine on January 4th 2021 and had body aches and diarrhea that night and following day. Symptoms have since resolved when self reported today.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Diarrhoea', 'Myalgia', 'Pain']",1,MODERNA,IM 981509,,34.0,M,"ErythemaMultiform, UrticariaPruritus, Itching eyes and lip Narrative: Allergic to foods. Started with itchy eyes and bottom lip. Progressed into itchy hands and neck. Monitored vitals and had pt stay 30 mins.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Erythema multiforme', 'Eye pruritus', 'Lip pruritus', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 981510,,32.0,F,"Headache, Fever, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Pyrexia']",1,MODERNA,IM 981511,,47.0,M,Syncope vasovagal syncope at time of vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Immediate post-injection reaction', 'Syncope']",1,MODERNA, 981512,,39.0,F,Syncope vasovagal syncope at time of vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Syncope'],1,MODERNA, 981570,,38.0,F,Dizziness Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Dizziness'],1,MODERNA,IM 981579,,49.0,F,"BlurredVision, Myalgia, Arthralgia, Fever, red painful eye diagnosed as nodular episcleritis Narrative: Took Tylenol 500mg, 1000mg BID",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Arthralgia', 'Episcleritis', 'Eye pain', 'Myalgia', 'Ocular hyperaemia', 'Pyrexia', 'Vision blurred']",1,PFIZER\BIONTECH,IM 981589,,61.0,F,"Headache, UrticariaPruritus, facial tingling and allodynia, shooting pain into right eye and teeth Narrative: self treated with rx gabapentin 200mg once then 100mg qhs for 4 nights",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/30/2020,,OTH,,,,"yes, Shingrix 2020 second dose had rigors post vaccine lasted appox 8 hrs",,"['Allodynia', 'Eye pain', 'Headache', 'Pain', 'Paraesthesia', 'Pruritus', 'Toothache', 'Urticaria']",1,MODERNA,IM 981596,,52.0,F,"Myalgia INJECTION SITE PAIN, MILD LASTING 3 DAYS Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Injection site pain', 'Myalgia']",1,MODERNA,IM 981602,,65.0,M,"Myalgia Fatigue, nasal congestion",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Fatigue', 'Myalgia', 'Nasal congestion']",UNK,PFIZER\BIONTECH, 981610,,48.0,F,Dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,['Dizziness'],1,MODERNA,IM 981615,,56.0,F,Headache & NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Headache', 'Nausea', 'Vomiting']",1,MODERNA, 981676,,41.0,F,Angioedema Tongue Tingling Narrative: Tingling decreased after 20 mins.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Angioedema', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 981684,,79.0,F,"Dizziness, Diarrhea, Palpitations & Tachycardia Narrative: Patient remained in facility for 15 minutes after receiving vaccination. Upon ambulating to depart facility, patient returned to area complaining of dizziness and fast heart beat. Patient was immediately seated and vital signs were obtained. 0954- BP 150/82, pulse 80, Oxygen saturation 95%, and temp 97.8. Patient drank 8 ounces water. Patient reported feeling better after 10 minutes. Repeat vital signs at 1007 BP 127/74, pulse 80, oxygen saturation 95%. Patient with no further complaints of dizziness or fast heart beat. Patient did not verbalize any other complaints. Patient denied escalation to emergency department. Condition was resolved prior to leaving facility. Patient left facility ambulatory without any difficultly, and was accompanied by family member. Patient instructed to call 911 and report to nearest emergency room for any further issues or complaints. Patient verbalized understanding of instructions in her own words.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,OTH,,,,,,"['Diarrhoea', 'Dizziness', 'Palpitations', 'Tachycardia']",1,PFIZER\BIONTECH,IM 981690,,59.0,M,Myalgia sharp pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,OTH,,,,,,"['Myalgia', 'Pain']",1,MODERNA,IM 981694,,53.0,F,"HYPERtension Narrative: 0930- Pt complained of not feeling well, VS taken, BP 182/85, HR 92, O2Sat 100%; Pt was placed on observation. 0944- VS taken again,BP 177/89, HR 94, O2Sat 100% 1000- Pt stated she was feeling better and event was probably due to anxiety; Pt declined going to ED; VS taken again, BP 149/83, HR 85, O2Sat 100%; Pt discharged home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,OTH,,,,,,"['Hypertension', 'Malaise']",1,PFIZER\BIONTECH,IM 981697,,33.0,F,"Headache, Myalgia, Arthralgia, Fever, CoughWheeze & Syncope Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Arthralgia', 'Cough', 'Headache', 'Myalgia', 'Pyrexia', 'Syncope', 'Wheezing']",1,MODERNA,IM 981703,,31.0,M,"Headache, Myalgia, Arthralgia, Tachycardia, fever=101.5, large (8x4 cm) wheal at injection site Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Injection site urticaria', 'Myalgia', 'Pyrexia', 'Tachycardia']",1,MODERNA,IM 981714,,39.0,M,"Myalgia, Fever, Chest congestion and soreness at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/31/2020,3.0,OTH,,,,,,"['Injection site pain', 'Myalgia', 'Pulmonary congestion', 'Pyrexia']",UNK,MODERNA, 981720,,36.0,F,"Dizziness, Headache, NauseaVomiting, insomnia, weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Asthenia', 'Dizziness', 'Headache', 'Insomnia', 'Nausea', 'Vomiting']",1,MODERNA,IM 981724,,39.0,M,Fatigue and soreness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/27/2020,,OTH,,,,,,"['Fatigue', 'Injection site pain']",UNK,MODERNA, 981732,,61.0,F,"Headache SORE ARM Narrative: headache the evening and next day that went away (12/29). I had arm soreness a day following the vaccination (12/29) that also went away. Sunday 1/3 flu symptoms (Diarrhea, fatigue, coughing and chest congestion). Today 1/5 USING inhaler due to cough, and SOB. 1/6 very fatigues and dizzy at times. Not feeling very well at all and uncertain if this is related to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Cough', 'Diarrhoea', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Headache', 'Influenza', 'Malaise', 'Pain in extremity', 'Respiratory tract congestion']",1,MODERNA,IM 981751,,36.0,F,Dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Dizziness'],1,MODERNA,IM 981758,,47.0,F,"Headache, NauseaVomiting, chest tightness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Chest discomfort', 'Headache', 'Nausea', 'Vomiting']",UNK,MODERNA,IM 981774,,62.0,M,"Dizziness, Myalgia, Arthralgia, Tachycardia, 12/29 fatigue, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Dizziness', 'Fatigue', 'Myalgia', 'Tachycardia']",1,MODERNA,IM 981775,,26.0,M,"Dizziness tongue numb Narrative: felt like tongue was numb, felt a little off, lightheaded, resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Dizziness', 'Feeling abnormal', 'Hypoaesthesia oral']",1,MODERNA,IM 981776,,42.0,F,"Myalgia, Arthralgia, Fever & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Arthralgia', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 981782,,45.0,F,"Myalgia, Fever, chills Narrative: Dec 31 9am fever 100.0 chills body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pain', 'Pyrexia']",1,MODERNA,IM 981785,,38.0,F,Myalgia & Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/31/2020,2.0,OTH,,,,,,"['Myalgia', 'Pyrexia']",UNK,MODERNA,IM 981792,,,M,"CoughWheeze Patient stated throat was itchy, advised to transport employee to ER, employee refused Narrative: Vital signs were taken Blood pressure 208/135, Pulse 100, O2 Saturation Room Air 98%. Patient states that blood pressure is around 200/100 and his provider is aware.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/31/2020,,OTH,,,,,,"['Blood pressure increased', 'Cough', 'Throat irritation', 'Wheezing']",1,PFIZER\BIONTECH,IM 981799,,28.0,F,SkinRash neck pain Narrative: instructed to contact her provider for evaluation,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Neck pain', 'Rash']",1,MODERNA,IM 981806,,57.0,F,"BlurredVision States she awoke w/cloudy vision, which has now cleared; feeling hot/cold; denies fever but had chills; Narrative: States she had COVID in July/2020 and felt these same symptoms; states her worse issue is that she feels exhausted; no appetite, not eaten last 24 hours; advised to go to nearest ER if condition gets worst; states she is taking tylenol alternating with ibuprofen as needed;",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Chills', 'Decreased appetite', 'Fatigue', 'Feeling of body temperature change', 'Vision blurred']",1,MODERNA,IM 981991,,34.0,M,"chills, sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Chills', 'Oropharyngeal pain']",1,MODERNA,IM 982033,,38.0,F,"chills, fatigue, rash. red induration at injection site, rash Narrative: took ibuprofen for AE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Injection site erythema', 'Injection site induration', 'Rash']",1,MODERNA,IM 982054,,48.0,F,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 982067,,38.0,F,"chills, fatigue, rash. red induration at injection site, rash Narrative: took ibuprofen for AE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Injection site erythema', 'Injection site induration', 'Rash']",1,MODERNA,IM 982082,,44.0,F,Headache & Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,OTH,,,,,,"['Headache', 'Myalgia']",UNK,MODERNA,IM 982092,,41.0,F,malaise Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,['Malaise'],1,MODERNA,IM 982099,,50.0,F,"HA ,throat tightness, tiny red spot last night 1/5/2021. 1/6/2021 -4.5X3.5 hard, red, swollen, tender spot at injection site R upper arm. Narrative: Pt experienced after vaccine was given on 1/5/20 HA ,throat tightness, tiny red spot last night 1/5/2021. 1/6/2021 -4.5X2.5 hard, red, swollen, tender spot at injection site R upper arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Erythema', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Throat tightness']",1,MODERNA,IM 982100,,52.0,F,"Headache, Myalgia, Fever, chills, arm pain, nausea, cough, fatigue, night sweats",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Cough', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Night sweats', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 982101,,52.0,F,"Headache, Myalgia, Fever, chills, arm pain, nausea, cough, fatigue, night sweats",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Cough', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Night sweats', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 982102,,32.0,M,"Dizziness, Headache, Myalgia, Arthralgia, Fever, Tachycardia, cough;fatigue Narrative: 1000 12/29 dry cough, extremely achy joint pain, fever <100 degrees Farenheit, tachycardia 120-130, headache, dizziness, and fatigue. 12/30 symptoms subsided approximately 1200 12/30",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Arthralgia', 'Cough', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Pain', 'Pyrexia', 'Tachycardia']",1,MODERNA,IM 982103,,50.0,M,"Dizziness, increased blood pressure, dry mouth Narrative: Within 10 minutes of receiving vaccine patient complaining of dizziness, increased blood pressure and dry mouth. Sent to urgent care within the building for evaluation. EKG performed. No meds given",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Blood pressure increased', 'Dizziness', 'Dry mouth']",1,MODERNA,IM 982104,,43.0,F,"Headache fatigue, injection site pain/arm soreness more severe than the 1st dose Narrative: Was able to sleep off her side effects. Took 800mg Ibuprofen OTC which helped. Afebrile.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Injection site pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 982106,,60.0,M,Diarrhea Reports 6x/day watery bowel movements since the morning after vaccination. 6 days so far. Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,OTH,,,,,,['Diarrhoea'],1,MODERNA,IM 982107,,37.0,F,"Headache, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative: Employee reported adverse events lasted for 2 to 2.5 days then resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 982108,,51.0,M,"Headache, Myalgia, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Headache', 'Malaise', 'Myalgia']",1,MODERNA,IM 982109,,54.0,F,delayed robust reaction at injection site > 8 days post vax Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,OTH,,,,,,['Injection site reaction'],1,MODERNA,IM 982110,,58.0,M,Myalgia fatigue Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Fatigue', 'Myalgia']",UNK,MODERNA, 982146,,64.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 982147,,62.0,F,site redness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,OTH,,,,,,['Injection site erythema'],UNK,MODERNA,IM 982148,,54.0,F,"Headache, Fever, weakness, malaise Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Asthenia', 'Headache', 'Malaise', 'Pyrexia']",1,MODERNA,IM 982151,,58.0,F,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,['Myalgia'],UNK,MODERNA,IM 982152,,50.0,M,"Myalgia, Fever, NauseaVomiting, Chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Chills', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 982153,,54.0,F,"Headache, NauseaVomiting, HYPERtension & Tachycardia Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Headache', 'Hypertension', 'Nausea', 'Tachycardia', 'Vomiting']",1,MODERNA,IM 982154,,37.0,F,"dizziness, hypotension, bradycardia Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Bradycardia', 'Dizziness', 'Hypotension']",1,MODERNA,IM 982155,,62.0,M,itching Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,OTH,,,,,,['Pruritus'],UNK,MODERNA,IM 982156,,62.0,F,site redness Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,OTH,,,,,,['Erythema'],UNK,MODERNA,IM 982157,,54.0,F,"Headache, Fever, weakness, malaise Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Asthenia', 'Headache', 'Malaise', 'Pyrexia']",1,MODERNA,IM 982158,,58.0,F,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,['Myalgia'],UNK,MODERNA,IM 982159,,50.0,M,"Myalgia, Fever, NauseaVomiting, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Chills', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 982162,,44.0,F,Headache & Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,OTH,,,,,,"['Headache', 'Myalgia']",UNK,MODERNA,IM 982163,,54.0,F,"Headache, NauseaVomiting, Hypertension & Tachycardia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Headache', 'Hypertension', 'Nausea', 'Tachycardia', 'Vomiting']",1,MODERNA,IM 982166,,37.0,F,"dizziness, hypotension, bradycardia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Bradycardia', 'Dizziness', 'Hypotension']",1,MODERNA,IM 982167,,32.0,M,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,OTH,,,,,,['Headache'],2,PFIZER\BIONTECH, 982168,,62.0,M,itching,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,OTH,,,,,,['Pruritus'],UNK,MODERNA,IM 982169,,49.0,M,"Headache, Fever, NauseaVomiting, Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,OTH,,,,,,"['Chills', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA, 982170,,26.0,F,"Myalgia Chills, Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Myalgia']",UNK,MODERNA,IM 982171,,,F,"Fever, NauseaVomiting, GastricBleeding, Hemoptsis Narrative: Required a visit to the er, was given zofran and released",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Gastric haemorrhage', 'Haemoptysis', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 982172,,49.0,F,"Headache, Myalgia, Arthralgia, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/08/2021,2.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH,IM 982173,,51.0,F,ErythemaMultiform Sowllen lymph node rt gorin Narrative: Recxomended Benedryl and Ice,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,OTH,,,,,,"['Erythema multiforme', 'Lymphadenopathy']",1,MODERNA,IM 982174,,65.0,F,"UrticariaPruritus ""Red/swollen deltoid, itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/03/2021,6.0,OTH,,,,,,"['Erythema', 'Peripheral swelling', 'Pruritus', 'Urticaria']",1,MODERNA,IM 982175,,45.0,F,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 982176,,53.0,F,Rash DELAYED SWELLING AT THE INJECTION SITE,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,OTH,,,,,,"['Injection site swelling', 'Rash']",UNK,MODERNA, 982177,,34.0,F,Myalgia SWOLLEN ARM-SLIGHTLY Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,,,,,,"['Myalgia', 'Peripheral swelling']",UNK,MODERNA, 982178,,57.0,F,"Headache Runny nose, sore throat, lymph node swelling under l arm,lear and eye pain, L lower jaw pain Narrative: To see her private physician is symptoms do not improve",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/28/2020,,OTH,,,,,,"['Ear pain', 'Eye pain', 'Headache', 'Lymphadenopathy', 'Oropharyngeal pain', 'Pain in jaw', 'Rhinorrhoea']",1,MODERNA,IM 982179,,66.0,M,"Sedation, Arthralgia & Fever Narrative: Patient reports symptoms for approximately 48 hours, then complete resolution",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Arthralgia', 'Pyrexia', 'Sedation']",2,PFIZER\BIONTECH,IM 982187,,41.0,F,"Headache, NauseaVomiting, L arm soreness, fatigue, 1/3/2020-L eyelid drooping and now inflamed L breast cyst that was previously stable for 4 years",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Blepharitis', 'Breast cyst', 'Facial paralysis', 'Fatigue', 'Headache', 'Nausea', 'Pain in extremity', 'Vomiting']",1,MODERNA,IM 982188,,29.0,M,"Headache, Myalgia, Then he had lower right body soreness, then 12/29 myalgias and chills; all resolved on day 3 except for headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Pain']",1,PFIZER\BIONTECH,IM 982189,,34.0,F,"Diarrhea tingling & numbness to injection site and left leg, chills, off and on abdominal pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Abdominal pain', 'Chills', 'Diarrhoea', 'Hypoaesthesia', 'Injection site hypoaesthesia', 'Injection site paraesthesia', 'Paraesthesia']",1,MODERNA,IM 982190,,45.0,F,"Headache chills, runny nose",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Chills', 'Headache', 'Rhinorrhoea']",1,MODERNA,IM 982192,,58.0,F,"Headache, Fever, CoughWheeze & NauseaVomiting Narrative: COVID test on 1/5/21 was negative",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Cough', 'Headache', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting', 'Wheezing']",1,MODERNA,IM 982193,,60.0,F,"Fever, UrticariaPruritus, extreme soreness,itching, warmth, redness, swelling at site; right jawline sensation; loss taste/smell; fatigue; T100.4",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Ageusia', 'Anosmia', 'Facial discomfort', 'Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pruritus', 'Pyrexia', 'Urticaria']",1,MODERNA,ID 984787,,31.0,F,Chills and shivering,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,OTH,,,,,,['Chills'],1,PFIZER\BIONTECH,IM 984795,,32.0,F,"Headache, Myalgia, Arthralgia, NauseaVomiting, sore throat and runny nose",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Rhinorrhoea', 'Vomiting']",1,MODERNA,IM 984838,,42.0,F,"Headache, Myalgia, Fever, chills, pain at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,,,,,,"['Chills', 'Headache', 'Injection site pain', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 984950,,53.0,F,"Headache, Arthralgia, sweating,nasal congestion, sore throat Narrative: Had to stay home from work due to symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/31/2020,3.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Hyperhidrosis', 'Impaired work ability', 'Nasal congestion', 'Oropharyngeal pain']",1,MODERNA,IM 984951,,39.0,F,Rash Narrative: + Area of erythema slightly raised was noticed on 1/8/2021 at 5:30am. Reports she is atopic and is pregnant with 20 week fetus. Aware she was pregnant when she received the vaccine. Area of redness measures 3.5cm x 4cm. Denies itching.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/08/2021,9.0,OTH,,,,,,"['Dermatitis atopic', 'Erythema', 'Exposure during pregnancy', 'Rash', 'Swelling']",1,MODERNA,IM 984952,,49.0,F,"RED, SWOLLEN DELTOID WHERE VACCINE RECEIVED",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,OTH,,,,,,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 984958,,52.0,F,"Headache, Myalgia, Fever, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 984969,,27.0,M,"Headache, fever, sore throat, elevated BP",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Blood pressure increased', 'Headache', 'Oropharyngeal pain', 'Pyrexia']",1,MODERNA,IM 984981,,63.0,F,"Pain in vaccinated arm, joint pain, headache, chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Pain in extremity']",1,MODERNA,IM 984987,,55.0,F,"Diarrhea Bilat eye puffiness, right sided head congestion, nasal drip and diarrhea; lethargy last night; resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,,,,,,"['Diarrhoea', 'Lethargy', 'Periorbital swelling', 'Respiratory tract congestion', 'Upper-airway cough syndrome']",1,MODERNA,IM 984994,,63.0,M,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Headache', 'Myalgia']",UNK,PFIZER\BIONTECH,IM 985006,,39.0,F,"Myalgia malaise, chills, lightheaded, shakey",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/06/2021,5.0,OTH,,,,,,"['Chills', 'Dizziness', 'Malaise', 'Myalgia', 'Tremor']",1,MODERNA,IM 985058,,49.0,F,Eustachian tube inflammed otitis serous,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/25/2020,3.0,OTH,,,,,,"['Eustachian tube disorder', 'Middle ear inflammation', 'Otitis media']",1,MODERNA,IM 985064,,48.0,F,"Headache, Myalgia, Arthralgia & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 985102,,29.0,F,LEFT AUXILLARY LYMPH NODE PAIN AND SWELLING,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/07/2021,8.0,OTH,,,,,,['Lymphadenopathy'],1,MODERNA,IM 985107,,29.0,F,"Rash & UrticariaPruritus Narrative: erythemic mildly pruritic rash 4 inches x 4 inches at left deltoid injection site tender touch, developed 1/5/2021. Taking zyrtec x 2 days in evening without relief of pruritis and Ibuprofen 1/7/2021 evening with relief of pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,OTH,,,,,,"['Erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Rash pruritic', 'Urticaria']",1,MODERNA,IM 985112,,57.0,F,"Fever Sore arm around 12 noon; chills 10pm for an hour, then fever 101-3F; relieved with tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,,,,,,"['Chills', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 985118,,44.0,F,"Joint pain, muscle pain, facial swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/02/2021,2.0,OTH,,,,,,"['Arthralgia', 'Myalgia', 'Swelling face']",1,MODERNA,IM 985124,,61.0,F,Rash & UrticariaPruritus,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/06/2021,7.0,OTH,,,,,,"['Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 985129,,65.0,M,"Chills, congestion, fatigue Narrative: Employee tested positive for COVID-19 on 1/5/21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,OTH,,,,,,"['COVID-19', 'Chills', 'Fatigue', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,MODERNA,IM 985135,,44.0,M,"injection arm left deltoid pain (sharp pain with movement and dullache at rest) Narrative: left deltoid pain immediately after vaccine, intermittent. came to occupational health for in person apt with NP 1/8 now constant pain 2-9/10 sharp pain with movement and dull ache otherwise. Had deltoid shoulder pain prior to vaccination, taking ibuprofen. 1/11 ortho apt scheduled. NP instructed pt to continue to take ibuprofen as needed and proceed with scheduled ortho apt.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,OTH,,,,yes Tdap.,,"['Immediate post-injection reaction', 'Injection site pain', 'Pain']",1,MODERNA,IM 985141,,40.0,F,Fever None Narrative: Employee was swabbed for COVID on 1/8/21,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Pyrexia', 'SARS-CoV-2 test']",1,MODERNA,IM 985145,,37.0,F,"Chills, Nausea, Diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Chills', 'Diarrhoea', 'Nausea']",1,MODERNA,IM 985150,,60.0,F,TRIANGLE-SHAPED REDNESS & SWELLING OF LEFT DELTOID WHERE VACCINE RECEIVED,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,OTH,,,,,,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 985155,,39.0,F,"Headache 12/24 dizziness, lethargy 12/26-12/27 itchy dry eyes 1/1 headache, 1/5-1/7 dry white pus around eyes Narrative: 12/24 afternoon 15-20 minutes dizziness, slept a little bit. 12/26-27 itchy eyes hx of dry itchy eyes, but reports not like this. 1/1 headache for 4 hr, back neck usually never have a headaches. 1/5-1/7 dry white pus around eyes. Instructed to call covid hotline for rule out. 1/7 Covid result negative. RN will follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Condition aggravated', 'Dizziness', 'Dry eye', 'Eye pruritus', 'Eyelid margin crusting', 'Headache', 'Lethargy', 'Neck pain', 'SARS-CoV-2 test negative']",1,MODERNA,IM 985324,,57.0,M,"""Blah feeling"" - malaise Narrative: Employee tested positive for COVID-19 on 1/4/21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/04/2021,6.0,OTH,,,,,,"['COVID-19', 'Feeling abnormal', 'Malaise', 'SARS-CoV-2 test positive']",1,MODERNA,IM 985333,,54.0,M,Headache Sore at site of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Headache', 'Injection site pain']",1,MODERNA,IM 985334,,75.0,M,brief period of unresponsiveness with lethargy and breathlessness,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Dyspnoea', 'Lethargy', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 985335,,89.0,M,lethargy Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,OTH,,,,,,['Lethargy'],2,PFIZER\BIONTECH,IM 985457,,103.0,M,Cellulitis of injected arm Narrative: Resolved after 5 days abx tx. No further reaction noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2020,,OTH,,,,,,['Injection site cellulitis'],1,MODERNA,IM 985839,,41.0,F,Fever chills Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,,,,,,"['Chills', 'Pyrexia']",1,MODERNA,IM 985840,,39.0,F,"Headache sore arm, malaise Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Headache', 'Malaise', 'Pain in extremity']",1,MODERNA,IM 985842,,63.0,M,Headache & Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 985843,,60.0,M,"Confusion, Headache, Myalgia, Fever, soreness at injection site starting after 12 hours, fatigue, lack of appetite, temp of 104.3 Narrative: employee was told to follow up with his physician and get tested for covid",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Confusional state', 'Decreased appetite', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 985844,,52.0,M,"Dizziness, Sedation, Myalgia, Diarrhea, CHILLS, VERY URGENT DIARRHEA Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Chills', 'Diarrhoea', 'Dizziness', 'Myalgia', 'Sedation']",1,MODERNA,IM 985845,,42.0,F,"Rash, ErythemaMultiform, UrticariaPruritus, moderate fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,,,,,,"['Erythema multiforme', 'Fatigue', 'Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 985846,,54.0,M,Arthralgia & SkinRash Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Arthralgia', 'Rash']",1,MODERNA,IM 985847,,37.0,F,"Headache fatigue, medication taste in throat, taste sensation off Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Taste disorder']",2,PFIZER\BIONTECH,IM 985848,,47.0,F,"Rash Redness, burning, swelling, indurated rash to L. arm Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/25/2020,12/25/2020,0.0,OTH,,,,,,"['Burning sensation', 'Erythema', 'Induration', 'Peripheral swelling', 'Rash']",1,MODERNA, 985849,,36.0,F,Headache & Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,OTH,,,,,,"['Headache', 'Myalgia']",2,PFIZER\BIONTECH,IM 985850,,38.0,M,"Phlebitis, UrticariaPruritus, INJECTION SITE WARM RED SWOLLEN AND ITCHY SUDDENLY 8 DAYS AFTER VACCINE Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,OTH,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Phlebitis', 'Pruritus', 'Urticaria']",1,MODERNA,IM 985862,,45.0,F,Headache & Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 985881,,51.0,F,"Headache, Sedation & Myalgia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Headache', 'Myalgia', 'Sedation']",1,MODERNA,IM 985930,,54.0,F,"Phlebitis RIGHT ARM SUDDENLY WITH REDNESS, WARMTH PAIN ON 1/6 AFTER VACCINE ON 12/29 Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,OTH,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Phlebitis']",1,MODERNA,IM 986004,,62.0,M,"Dizziness & Headache Narrative: Employee informed this RN that he ""I feel like I'm going to faint and I have a headache"". 0910-BP 121/73, HR 52 O2 sat 97% 0915-Employee states ""I still feel faint"". 0930-Eployee still states he feels faint and like he is going to pass out. Code assist called. 0935-120/76 HR-51. 0940-Employee still feeling faint, assisted to ER by ER staff via W/C for full evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,OTH,,,,,,"['Dizziness', 'Headache']",1,PFIZER\BIONTECH,IM 986021,,49.0,M,Phlebitis & Diarrhea Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Diarrhoea', 'Phlebitis']",1,MODERNA,IM 986035,,54.0,F,"Phlebitis, UrticariaPruritus, SWOLLEN LYMPH NODE ON COLLAR BONE Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Lymphadenopathy', 'Phlebitis', 'Pruritus', 'Urticaria']",1,MODERNA,IM 986053,,32.0,F,large red area at site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/08/2020,01/08/2021,31.0,OTH,,,,,,['Injection site erythema'],1,MODERNA,IM 986077,,46.0,M,"Headache, Sedation & Myalgia Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Headache', 'Myalgia', 'Sedation']",1,MODERNA,IM 986095,,59.0,F,"Phlebitis, UrticariaPruritus, INJECTION SITE SUDDENLY RED, WARM AND ITCHY ON 1/6 SEVEN DAYS POST VACCINE Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,OTH,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth', 'Phlebitis', 'Pruritus', 'Urticaria']",1,MODERNA,IM 986111,,43.0,F,"rash, redness Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/07/2021,9.0,OTH,,,,,,"['Erythema', 'Rash']",1,MODERNA,IM 986120,,50.0,F,"Myalgia, Fever FEVER OF 100.3",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Myalgia', 'Pyrexia']",1,MODERNA,IM 986133,,63.0,M,"Sweaty, clammy, faint Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,01/07/2021,,OTH,,,,,,"['Cold sweat', 'Dizziness', 'Hyperhidrosis']",1,MODERNA,IM 986136,,41.0,M,"Headache migraine, red/sore, warm at site of injection,body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,OTH,,,,,,"['Headache', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Migraine', 'Pain']",1,PFIZER\BIONTECH,IM 986144,,46.0,F,"Headache aches, peeling fingertips Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Headache', 'Pain', 'Skin exfoliation']",1,PFIZER\BIONTECH,IM 986148,,31.0,F,SWOLLEN LYMPH NODE ON LEFT COLLAR BONE ONE WEEK POST VACCINE,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,OTH,,,,,,['Lymphadenopathy'],1,MODERNA,IM 990725,,33.0,F,"Myalgia, Fever, FATIGUE AND SORENESS AT INJECTION SITE Narrative: SWABBED FOR COVID 12/29 NEGATIVE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Fatigue', 'Injection site pain', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 990726,,44.0,F,"HYPERgylcemia SCRATCHY THROAT, ELEVATED BLOOD GLUCOSE BY 50",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,,,,,,"['Blood glucose increased', 'Hyperglycaemia', 'Throat irritation']",1,MODERNA,IM 990727,,53.0,M,Dizziness & HYPERtension Narrative: Employee felt dizy had his b/p went up to 152/89 pulse 55 then 143/83 oxygen sats 97 percent on room aiar at 1218,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/08/2021,,OTH,,,,,,"['Blood pressure increased', 'Dizziness', 'Hypertension']",2,PFIZER\BIONTECH,IM 990728,,52.0,M,"Myalgia, Fever, LOSS OF TASTE AND SNELL, CHILLS Narrative: SWABBED FOR COVID 12/28 NEGATIVE RESULT",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Ageusia', 'Anosmia', 'Chills', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 990729,,65.0,F,"Headache, Palpitations, flushing, elevated blood pressure (134) and Heart rate (90) Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Blood pressure increased', 'Flushing', 'Headache', 'Heart rate increased', 'Palpitations']",1,MODERNA, 990730,,32.0,F,ErythemaMultiform & UrticariaPruritus Narrative: Recomended benedryl and ice,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/04/2021,9.0,OTH,,,,,,"['Erythema multiforme', 'Pruritus', 'Urticaria']",1,MODERNA,IM 990731,,42.0,M,"Headache, myalgia, fever & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/08/2021,2.0,OTH,,,,,,"['Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 990732,,62.0,F,"Myalgia, NauseaVomiting, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/08/2021,8.0,OTH,,,,,,"['Chills', 'Myalgia', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 990733,,43.0,F,"Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, chills alternating with sweats as well, fever continued for 2 days, also reporting swollen glands Narrative: Symptoms persisted for 48 hours, with some lingering symptoms beyond 48 hours (headache, aches, swollen glands)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Chills', 'Diarrhoea', 'Headache', 'Hyperhidrosis', 'Lymphadenopathy', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 990734,,30.0,M,"Dizziness, Headache & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Dizziness', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA, 990735,,43.0,F,"Headache, Myalgia, Fever, fatigue, chills, loss of appetite Narrative: Employee reports symptoms resolved in 48 hours, only used home tylenol for treatment",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 990736,,51.0,M,Fatigue Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,['Fatigue'],1,MODERNA, 990737,,51.0,F,"SkinRash & ErythemaMultiform Narrative: Itching of scalp, slight redness attributed to scratching by employee, no wheals or blisters",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Erythema', 'Erythema multiforme', 'Pruritus', 'Rash']",1,MODERNA,IM 990738,,46.0,F,"ErythemaMultiform arm soreness, localized swelling Narrative: arm soreness day of vaccination, localized swelling reported occurring the next day; took Tylenol twice, feels like symptoms are resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/07/2021,2.0,OTH,,,,,,"['Erythema multiforme', 'Pain in extremity', 'Swelling']",1,MODERNA,IM 990739,,58.0,M,"Headache, Myalgia, Arm pain at injection site and worsening of symptoms Narrative: Progressive headache symptoms and arm pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,,,,,,"['Condition aggravated', 'Headache', 'Injection site pain', 'Myalgia']",2,PFIZER\BIONTECH,IM 990740,,45.0,F,"UrticariaPruritus Puritic, erythematous, painful induration 9x6 cm Narrative: immed induration , resolved then recurred to 9x6cm red and painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/29/2020,7.0,OTH,,,,"yes, flu vacc redness at site self reported",,"['Erythema', 'Induration', 'Pain', 'Pruritus', 'Urticaria']",1,MODERNA,IM 990741,,41.0,M,"Headache, Arthralgia & Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Pyrexia']",1,MODERNA,IM 990742,,58.0,F,CRAMP IN FEET Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,['Muscle spasms'],UNK,MODERNA,IM 990743,,38.0,M,Myalgia & Phlebitis Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,OTH,,,,,,"['Myalgia', 'Phlebitis']",1,MODERNA,IM 990744,,61.0,M,"Headache, Myalgia, SINUS COLD SYMPTOMS AND ROSY CHEEKS Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Headache', 'Myalgia', 'Nasopharyngitis', 'Sinus disorder', 'Skin discolouration']",UNK,MODERNA,IM 990745,,58.0,M,"Headache, Sedation, Myalgia & Arthralgia Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Myalgia', 'Sedation']",1,MODERNA,IM 990746,,54.0,M,"Headache, Myalgia, Arthralgia & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 990747,,40.0,M,"Dizziness, Headache & NauseaVomiting Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,OTH,,,,,,"['Dizziness', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 990748,,38.0,F,"BlurredVision, Headache, CoughWheeze, Hypertension, Syncope, shortness of breath",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/25/2020,2.0,OTH,,,,,,"['Cough', 'Dyspnoea', 'Headache', 'Hypertension', 'Syncope', 'Vision blurred', 'Wheezing']",UNK,MODERNA,IM 990751,,53.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,['Myalgia'],UNK,MODERNA,IM 990758,,37.0,M,"Myalgia, Arthralgia & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Arthralgia', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 990766,,63.0,F,SORENESS AT INJECTION SITE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA,IM 990775,,34.0,M,"Headache, Seizures, UrticariaPruritus & NauseaVomiting Narrative: NORMALLY HAVE SEIZURES EVERY EVENING, BUT THIS SEIZURE ABOUT 5.5 HRS POST VACCINE WAS MUCH MORE SEVERE WITH ""EYES ROLLING IN BACK OF HEAD"" AND FELT ""IN A DAZE"". TOOK AN EXTRA DOSE OF CLONAZIPAM 1 MG",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Eye movement disorder', 'Feeling abnormal', 'Headache', 'Nausea', 'Pruritus', 'Seizure', 'Urticaria', 'Vomiting']",1,MODERNA,IM 990802,,51.0,M,Headache migraine (date of event not listed) Narrative: Treated with OTC tylenol,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,['Migraine'],1,MODERNA,IM 990821,,33.0,M,Myalgia Soreness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Injection site pain', 'Myalgia']",UNK,MODERNA,IM 990828,,43.0,F,"Myalgia, Arthralgia, Diarrhea, NauseaVomiting, Chills and soreness at injection site Narrative: Missed one day of work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Diarrhoea', 'Impaired work ability', 'Injection site pain', 'Myalgia', 'Nausea', 'Vomiting']",UNK,MODERNA,IM 990829,,27.0,M,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,OTH,,,,,,['Unevaluable event'],UNK,MODERNA,IM 990840,,57.0,F,"Myalgia, SkinRash, Rash & UrticariaPruritus Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,OTH,,,,,,"['Myalgia', 'Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 990848,,63.0,F,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,['Myalgia'],UNK,MODERNA,IM 990850,,46.0,F,"Myalgia, NauseaVomiting, Left Arm pain, fatigue, sharp muscle pain, nausea Narrative: Rest, fluids, Tylenol and Motrin at home",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Fatigue', 'Myalgia', 'Nausea', 'Pain in extremity', 'Vomiting']",1,PFIZER\BIONTECH,IM 990852,,30.0,M,"Dizziness, Headache, Had sore arm and ""felt like hell, thought I was going to pass out"" Very weak and fatigued. Had headache. Slept from 5:30pm on Tues till 14:30pm on 12/30. Fells fine on 12/31/20. Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Asthenia', 'Dizziness', 'Fatigue', 'Headache', 'Pain in extremity']",1,MODERNA,IM 990854,,28.0,F,"mild throat tightness Narrative: approx 15 mins after vaccine administered employee started having mild throat tightness -- 25mg po benadryl given -- within 10-15mins, symptoms resolved - she was evaluated by a MD --",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/31/2020,,OTH,,,,,,['Throat tightness'],1,MODERNA,IM 990855,,39.0,F,"Myalgia, Arthralgia, SkinRash & Rash Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Arthralgia', 'Myalgia', 'Rash']",1,MODERNA,IM 990856,,51.0,F,Headache & Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Headache', 'Pyrexia']",1,MODERNA,IM 990857,,53.0,M,"Myalgia, Arthralgia & Fever Narrative: Previously COVID positive. Symptoms following injection similar to symptoms while positive.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Arthralgia', 'Myalgia', 'Pyrexia']",UNK,MODERNA, 990858,,41.0,F,"UrticariaPruritus, NauseaVomiting, pain and swelling at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Injection site pain', 'Injection site swelling', 'Nausea', 'Pruritus', 'Urticaria', 'Vomiting']",UNK,MODERNA,IM 990859,,58.0,F,Pain in left arm from deltoid to elbow and up neck Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/31/2020,,OTH,,,,,,"['Injection site pain', 'Neck pain']",1,MODERNA,IM 990860,,43.0,F,"FATIGUE,CHILLS,SORENESS AT INJECTION SITE Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Injection site pain']",UNK,MODERNA,IM 990861,,65.0,F,"Headache, Fever, BODY ACHES, CHILLS Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/30/2020,4.0,OTH,,,,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 990862,,66.0,F,Fatigue and soreness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Fatigue', 'Injection site pain']",UNK,MODERNA,IM 990864,,29.0,F,"Dizziness, NauseaVomiting, Vertigo Narrative: Employee observed for 15 min in clinic after Vaccination. Went back to work, as Clinical Pharmacist. Found she felt dizzy, vertigo, and nauseated. Unable to concentrate or focus on her work. She went home to recover",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Dizziness', 'Nausea', 'Vertigo', 'Vomiting']",1,PFIZER\BIONTECH,IM 990869,,52.0,M,SORENESS AT INJECTION SITE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA,IM 990880,,52.0,F,"Myalgia, Fever, SWOLLEN LEFT CLAVICLE LYMPH NODE Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/30/2020,4.0,OTH,,,,,,"['Lymphadenopathy', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 990899,,50.0,F,Myalgia Fatigue and soreness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Fatigue', 'Injection site pain', 'Myalgia']",UNK,MODERNA,IM 990900,,44.0,M,"Myalgia & Fever Narrative: Hx of prior Covid infection on 12-4-20. Reported fever, chills, and myalgias.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 990901,,67.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 990902,,38.0,M,Myalgia Fatigue Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Fatigue', 'Myalgia']",UNK,MODERNA, 990903,,49.0,M,Diarrhea Chills; paint and itching at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Chills', 'Diarrhoea', 'Injection site pain', 'Injection site pruritus']",UNK,MODERNA, 990904,,28.0,M,Fatigue x2 days; pain at injection site x3days Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Fatigue', 'Injection site pain']",UNK,MODERNA, 990905,,58.0,M,"Diarrhea, NauseaVomiting, Facial flushing, shortness of breath, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Dyspnoea', 'Fatigue', 'Flushing', 'Nausea', 'Vomiting']",1,MODERNA,IM 990910,,26.0,F,"Myalgia, Fever, F(101.5) Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 990916,,44.0,F,"Myalgia chills, body aches Narrative: Treated with OTC ibuprofen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pain']",1,MODERNA,IM 990921,,40.0,M,"Headache, NauseaVomiting, Starting 1/4/21 evening, experienced HA, NV, and lymphadenopathy in left axilla through 1/6/21 Narrative: Took OTC tylenol for HA",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Headache', 'Lymphadenopathy', 'Nausea', 'Vomiting']",1,MODERNA,IM 990926,,49.0,F,"Headache, Myalgia, tired, weak, could not look at her computer, pain at the injection site Narrative: Did not feel that needs to see the doctor today. Could not look at her computer at work. Left work today, felt the need to lay down and rest.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Asthenia', 'Fatigue', 'Headache', 'Impaired work ability', 'Injection site pain', 'Myalgia']",1,MODERNA,IM 990932,,37.0,M,"Dizziness, Headache & Myalgia Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Dizziness', 'Headache', 'Myalgia']",1,MODERNA,IM 990938,,61.0,F,"Pining on left side of head, ""not even a headache""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,['Headache'],1,MODERNA,IM 990945,,32.0,F,"Myalgia, Fever, SkinRash, NauseaVomiting, chills, rhinorrhea, sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Chills', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Pyrexia', 'Rash', 'Rhinorrhoea', 'Vomiting']",1,MODERNA,IM 990954,,66.0,M,Confusion disorientation; pain at injection site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Confusional state', 'Disorientation', 'Injection site pain']",UNK,MODERNA, 990963,,67.0,F,"Diarrhea, NauseaVomiting, Tachycardia, tachycardia, NVD approximately 12 hours post injection Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Diarrhoea', 'Nausea', 'Tachycardia', 'Vomiting']",1,MODERNA,IM 990971,,40.0,F,"UrticariaPruritus redness, itchy, hot, swollen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/31/2020,3.0,OTH,,,,,,"['Erythema', 'Feeling hot', 'Pruritus', 'Swelling', 'Urticaria']",1,MODERNA,IM 990978,,38.0,F,"Rash Chills, Ftaigue Narrative: Took OTC ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Rash']",1,MODERNA,IM 990983,,62.0,M,"Headache HA, diarrhea, dry mouth, hot, lightheadedness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Diarrhoea', 'Dizziness', 'Dry mouth', 'Feeling hot', 'Headache']",1,MODERNA,IM 990991,,46.0,M,Myalgia Fatigued,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Fatigue', 'Myalgia']",UNK,MODERNA, 990998,,52.0,F,ErythemaMultiform Pt complains of flushing; chest/neck/face/ears reddened; VS: P-126; R-16; BP-158/98;SAT-100%; Dr at bedside to evaluate pt. 1300- No repiratory distress;VS- 143/83; 104; 100%; 16; MD advised pt to take 25-50mg of benadryl every 6 hrs for 24 hr Narrative: Patient with flushed skin; VSS; denies difficulty breathing; advised by Dr to take 25-50mg benadryl every 6hrs and follow up if any change in or worsening of symptoms. Ambulated from clinic with husband. No assistance needed.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Erythema', 'Erythema multiforme', 'Flushing']",1,PFIZER\BIONTECH,IM 991006,,48.0,F,"Headache, Myalgia, Rigors, fevers, and frontal headaches Narrative: 12 hours after vaccine given, experienced severe, extreme rigors, along with fevers to 103.2, unresponsive to acetaminophen and ibuprofen. Also reported intractable headache (mostly frontal). 24 hours later, temperature reported as normal. Of note, reports history of mild COVID before (positive PCR 11/2020 with symptoms but never severe).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Pyrexia']",2,MODERNA,IM 991012,,43.0,F,Employee exhibited right hip warmth and tightness that radiated to her right jaw Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Feeling hot', 'Muscle tightness']",1,MODERNA,IM 991226,,46.0,F,Myalgia RLE aching,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/25/2020,2.0,OTH,,,,,,"['Myalgia', 'Pain in extremity']",UNK,MODERNA, 991234,,61.0,F,"Dizziness, Sedation, NUMBNESS OF FOREHEAD Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,yesNEUROPATHIC PAIN WITH FLU SHOTS,,"['Dizziness', 'Hypoaesthesia', 'Sedation']",UNK,MODERNA, 991241,,66.0,F,"SkinRash & Diarrhea Narrative: Hives general systemic, head, palms,right eye lid, back, abdomen. Hives continued to pop up for the next four days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 991247,,46.0,F,Right eye twitching,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/27/2020,4.0,OTH,,,,,,['Blepharospasm'],UNK,MODERNA, 991253,,53.0,F,"Dizziness Weakness Narrative: Reported weakness and dizzy. Evaluated by NP. VS taken initial - BP 156/91, HR 76, O2 sat 94% on RA. Continued monitor - BP 169/ , 162/88 O2sat 100% on RA. Lungs clear, no wheezing or SOB reported. Pt was able to hold conversation with nursing staff w/ no issues. Pt reports she took half a tablet of her HCTZ today and indicated she will follow up with her primary care MD regarding her elevated BP. Reports feeling better after resting. No signs of symptoms of distress noted @ 1230. Vitals BP 152/84 HR 69.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Asthenia', 'Blood pressure increased', 'Dizziness']",1,MODERNA,IM 991261,,55.0,F,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/25/2020,2.0,OTH,,,,,,"['Headache', 'Myalgia']",1,PFIZER\BIONTECH,IM 991265,,45.0,F,"Headache, Fever & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,,,,unknown,,"['Headache', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 991274,,63.0,M,Fatigue; continued pain to injection site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/25/2020,2.0,OTH,,,,,,"['Fatigue', 'Injection site pain']",UNK,MODERNA, 991279,,58.0,M,tenderness at injection site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 991288,,63.0,F,Soreness and bruising at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Injection site bruising', 'Injection site pain']",UNK,MODERNA, 991294,,45.0,M,NauseaVomiting Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Fatigue', 'Nausea', 'Vomiting']",UNK,MODERNA, 991301,,45.0,M,Headache fatigue Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/29/2020,6.0,OTH,,,,,,"['Fatigue', 'Headache']",UNK,MODERNA, 991320,,50.0,F,"Myalgia Chills and skin hurting Narrative: Had COVID in Sept. The myalgia,chills,skin hurting were a mild version of what she had during active COVID infection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pain of skin']",UNK,MODERNA, 991337,,60.0,F,SkinRash & NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,"yes, reports that she is unsure of the date - about 5 years ago had the exact same reaction to a flu vaccine",,"['Nausea', 'Rash', 'Vomiting']",1,PFIZER\BIONTECH,IM 991344,,38.0,M,"Dizziness, Headache, Myalgia & NauseaVomiting Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Dizziness', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 991350,,44.0,F,"Dizziness, Headache & NauseaVomiting Narrative: Need to stay home due to N/V, missed work day.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Dizziness', 'Headache', 'Impaired work ability', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 991358,,57.0,F,Arthralgia & Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Arthralgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 991362,,58.0,F,SORENESS AT INJECTION SITE//FATIGUE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Fatigue', 'Injection site pain']",UNK,MODERNA, 991363,,50.0,M,pain/tenderness at injection site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 991364,,58.0,M,Tenderness at injection site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/23/2020,,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 991366,,61.0,M,fatigue Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Fatigue'],UNK,MODERNA, 991371,,61.0,M,Diarrhea Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,['Diarrhoea'],UNK,MODERNA, 991379,,61.0,M,Fatigue remains Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Fatigue'],UNK,MODERNA, 991611,,57.0,M,"BlurredVision, Dizziness, Headache & Myalgia Narrative: Vaccine administered left deltoid 1050am at approx 1052 began to feel sharp pain from left arm/shoulder to neck and then felt dizzy with mild blurred vision. Subsequent pain on left deltoid with movement of arm. VS 124/73;71; 14; 99%; 97.6 . assisted to lay on cart supine and dizziness subsided developed mild frontal headache. Remained on stretcher for aprox 25 minutes and gradual elevation of head of bed with continued resolution of symptoms with stable vital signs. Patient got off cart on own and wanted to leave as she felt much better. VS standing 1155 113/73;70; 14; 99% no dizziness, no visual changes, mild headache and decreased pain in left deltoid. Ambulated without any assistance, gait steady no apparent distress, patient returned to work area and advised return if symptoms return or to go to the ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Arthralgia', 'Dizziness', 'Headache', 'Neck pain', 'Pain', 'Pain in extremity', 'Vision blurred']",1,MODERNA,IM 991618,,56.0,F,TENDERNESS AT INJECTION SITE// STIFF NECK AT BASE OF SKULL LASTED 2HR Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Injection site pain', 'Musculoskeletal stiffness']",UNK,MODERNA, 991638,,65.0,F,"Headache, Myalgia, SORE ARM HEADACHE LASTED 30 MIN Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pain in extremity']",UNK,MODERNA, 991720,,50.0,F,Soreness and erythema at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Injection site erythema', 'Injection site pain']",UNK,MODERNA, 991792,,64.0,M,NONE Narrative: NO REACTIONS REPORTED,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['No adverse event'],UNK,MODERNA, 991793,,69.0,M,Myalgia neck pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/26/2020,3.0,OTH,,,,,,"['Myalgia', 'Neck pain']",UNK,MODERNA, 991794,,41.0,F,"Palpitations Narrative: Employee received vaccine at 8am on 12-29. 45 minutes later experienced flushed feeling, heart palpitations, chest pain. See in urgent care at work, EKG showed ectopy. She was sent to the nearby emergency room, where she was monitored and given iv fluids, oxygen and tylenol. She is feeling better today one day later, and will have follow-up with cardiology. Vaccine administration may have set off underlying predisposition for PVC's, ectopy. Was aware of PVC's previously but well-controlled on diltiazem. Has now been switched to metoprolol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chest pain', 'Electrocardiogram abnormal', 'Extrasystoles', 'Flushing', 'Palpitations', 'Ventricular extrasystoles']",1,PFIZER\BIONTECH,IM 991795,,50.0,F,"UrticariaPruritus Narrative: 12/19-12/21 hives to R wrist, chest, back, neck",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,OTH,,,,,,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 991796,,34.0,F,Sedation Narrative: MODERATE FATIGUE X 3 DAYS,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,OTH,,,,,,"['Fatigue', 'Sedation']",1,MODERNA,IM 991798,,70.0,F,"Headache extreme fatigue, did not work yesterday; Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/25/2020,4.0,OTH,,,,,,"['Fatigue', 'Headache', 'Impaired work ability']",1,PFIZER\BIONTECH,IM 991799,,44.0,M,"Headache, UrticariaPruritus, 12-29-20 awakended with body aches and temp of 101.9 Narrative: Received Moderna Vaccine #1 at approx. 9:15 am. Headache started around 1030, generalized itching around noon. Benadryl 50mg PO q4h PRN prescribed x 1 day. Called today, 12-20 reporting body aches and temp of 101.9. Itching has improved since yesterday. Patient states, ""I feel like I've been hit by a truck.""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Body temperature increased', 'Headache', 'Pain', 'Pruritus', 'Urticaria']",1,MODERNA,IM 991800,,29.0,F,Myalgia & NauseaVomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Myalgia', 'Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH, 991801,,36.0,F,"Headache, Myalgia, Fever, NauseaVomiting, Chills and fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",UNK,MODERNA, 991802,,50.0,M,Myalgia pain to injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Injection site pain', 'Myalgia']",UNK,MODERNA, 991803,,63.0,M,soreness to injection site;,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 991804,,57.0,F,PAIN AT INJECTION SITE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 991805,,46.0,M,PAIN AT INJECTION SITE AND FATIGUE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Fatigue', 'Injection site pain']",UNK,MODERNA, 991806,,48.0,M,Fatigue; tenderness at injection site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Fatigue', 'Injection site pain']",UNK,MODERNA, 991807,,44.0,F,SORENESS AT INJECTION SITE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 991808,,61.0,F,SORENESS AT INJECTION SITE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 991809,,37.0,M,none Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Unevaluable event'],UNK,MODERNA, 991810,,47.0,M,none Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Unevaluable event'],UNK,MODERNA, 994026,,44.0,M,Redness/warmth to injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Injection site erythema', 'Injection site warmth']",UNK,MODERNA, 994027,,58.0,M,"Headache, Myalgia & Arthralgia Narrative: Developed headache shortly after vaccination, dose 1. Over time also experienced muscle and joint aches. Missed one day of work. Used ibuprofen. Feeling better now.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Myalgia']",1,PFIZER\BIONTECH,IM 994028,,45.0,F,Pain at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 994029,,32.0,F,Headache & NauseaVomiting Narrative: Developed symptoms of nausea and headache several hours after vaccine administration (12-22-20). Up late with symptoms of vomiting. Missed work the next day (12-23-20). Feeling much better by noon of the next day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Headache', 'Impaired work ability', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 994030,,45.0,M,pain at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 994031,,52.0,F,Soreness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 994032,,60.0,F,Light headed lasted 3-4 hr,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,['Dizziness'],UNK,MODERNA, 994033,,48.0,M,Headache tenderness to injection site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Headache', 'Injection site pain']",UNK,MODERNA, 994034,,36.0,F,Soreness and bruising at injection site/pain in knee just as she had when she had the covid virus,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Arthralgia', 'Injection site bruising', 'Injection site pain']",UNK,MODERNA, 994035,,62.0,F,Soreness and warmth at iinjection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Injection site pain', 'Injection site warmth']",UNK,MODERNA, 994036,,50.0,M,Fatigue; pain at injection site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Fatigue', 'Injection site pain']",UNK,MODERNA, 994037,,41.0,F,"Rash & UrticariaPruritus Narrative: Developed urticaria (welt) over the vaccine site hours after receiving vaccine. mild tenderness, then rash after several hours and became itchy. Employee is concerned about the level of protection (antibody titer produced)because allegedly given subcutaneous rather than intramuscular",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,OTH,,,,,,"['Incorrect route of product administration', 'Pruritus', 'Rash', 'Rash pruritic', 'Tenderness', 'Urticaria']",1,PFIZER\BIONTECH,IM 994038,,69.0,M,Pain at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 994039,,69.0,M,pain at inject site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 994040,,50.0,F,"Myalgia, Arthralgia, Fever & NauseaVomiting Narrative: About 5-6 hours after injection arm became sore and could not raise it. Approximately 24 hours after injection had chills & muscle aches. Previously COVID positive and these symptoms were the same as when she had COVID infection. Two days after injection (morning of this report) no longer having chills, but very fatigued and nauseated.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Injected limb mobility decreased', 'Injection site pain', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",UNK,MODERNA, 994041,,45.0,F,Pain at injection site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 994052,,71.0,M,Fatigue; overwhelming feeling of sadness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Depressed mood', 'Fatigue']",UNK,MODERNA, 994072,,46.0,F,Soreness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 994085,,37.0,M,"Arthralgia joint pain to hip, elbows and any bony prominences: employee also mentioned she has sickle cell Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Arthralgia'],UNK,MODERNA, 994086,,58.0,M,pain/tenderness to injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 994087,,62.0,F,Soreness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 994088,,39.0,M,SORENESS AT INJECTION SITE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 994089,,55.0,M,SORENESS AT INJECTION SITE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 994090,,49.0,F,Pain/tenderness at injection site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 994091,,60.0,F,SORENESS AND ERYTHEMA AT INJECTION SITE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,SHINGLES VACCINE INJECTION SITE EDEMATOUS AND PURPLE,,"['Injection site erythema', 'Injection site pain']",UNK,MODERNA, 994092,,45.0,M,TENDERNESS AT INJECTION SITE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 994157,,50.0,F,SORENESS AT INJECTION SITE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 994158,,36.0,M,"""small burning sensation in throat"", mild numbness in left side of tongue, mild headache Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/30/2020,,OTH,,,,,,"['Headache', 'Hypoaesthesia oral', 'Throat irritation']",1,MODERNA,IM 994159,,65.0,M,Soreness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA, 994160,,28.0,F,Myalgia Narrative: Localized injection site tenderness and induration- mild,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/30/2020,8.0,OTH,,,,,,"['Injection site induration', 'Injection site pain', 'Myalgia']",1,PFIZER\BIONTECH,IM 994161,,44.0,M,Myalgia Sore arm only,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Myalgia', 'Pain in extremity']",UNK,MODERNA, 994162,,49.0,F,"Right axilla painful Lymphadenopathy noted 12/27, Sore right arm at injection site improved after 72 hours, no other symptoms reported Narrative: No treatment necessary at this time. Will continue to monitor. Advise to seek care/call occupational health if concerns arise or anything worsens. Reports right arm injection site soreness improved after 72 hours, no other symptoms reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/27/2020,4.0,OTH,,,,,,"['Injection site pain', 'Lymphadenopathy']",1,MODERNA,IM 994163,,67.0,F,Myalgia SORE ARM ONLY Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Myalgia', 'Pain in extremity']",UNK,MODERNA, 994164,,25.0,M,"Dizziness, Headache, numbness in the head, hands; feeling cold, sensitive to temperature, tired. Narrative: The employee stated that he will not need to see ED provider at this time. He will, if sx get worse. Was advised to seek care from PCP, and alert Occupational Health if any changes. The employee in agreement.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/29/2020,6.0,OTH,,,,,,"['Dizziness', 'Feeling cold', 'Headache', 'Hypoaesthesia', 'Temperature intolerance']",1,MODERNA,IM 994165,,61.0,F,ARM SORE ONLY Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Pain in extremity'],UNK,MODERNA, 994166,,59.0,F,SORE ARM ONLY Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Pain in extremity'],UNK,MODERNA, 994167,,34.0,F,Myalgia ARM SORE AND BRUISED NARRATIVE:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Contusion', 'Myalgia', 'Pain in extremity']",UNK,MODERNA, 994168,,27.0,F,"Headache, Myalgia, CoughWheeze, NauseaVomiting, Panic Attacks-on sunday Narrative: Went and got a COVID test on Mon 12/28/2020",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Cough', 'Headache', 'Myalgia', 'Nausea', 'Panic attack', 'SARS-CoV-2 test', 'Vomiting', 'Wheezing']",1,MODERNA,IM 994181,,43.0,M,"CoughWheeze Congestion, Fatigue, Local injection site tenderness Narrative: Took OTC naproxen and zyrtec.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Cough', 'Fatigue', 'Injection site pain', 'Respiratory tract congestion', 'Wheezing']",1,MODERNA,IM 994198,,45.0,F,Bell's Palsy started 12/24 or 12/25/2020 Narrative: Currently being treated by her Primary Care Provider with prednisone,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/24/2020,6.0,OTH,,,,,,"[""Bell's palsy""]",1,PFIZER\BIONTECH,IM 994217,,36.0,M,"Headache, Myalgia & Diarrhea Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Headache', 'Myalgia']",UNK,PFIZER\BIONTECH, 994224,,49.0,F,"UrticariaPruritus, Diarrhea & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Nausea', 'Pruritus', 'Urticaria', 'Vomiting']",1,PFIZER\BIONTECH,IM 994225,,32.0,F,"Headache, Myalgia, Fever, Fever 101.6 ay 8:00PM, Fatigue-Fever and fatigue lasted the longest-5 days Narrative: Did not feel well with the fever and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 994226,,53.0,M,Myalgia ARM SORE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Myalgia', 'Pain in extremity']",UNK,MODERNA, 994227,,49.0,F,Headache & NauseaVomiting Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Headache', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 994228,,58.0,F,"Myalgia tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, myalgia Narrative: tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, myalgia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,"['Cough', 'Dysgeusia', 'Myalgia', 'Paraesthesia', 'Paraesthesia oral', 'Throat irritation']",1,PFIZER\BIONTECH,IM 994229,,36.0,M,"Myalgia, Fever, Chills Narrative: Bed rest times 2 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Bed rest', 'Chills', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 994230,,41.0,F,"Depression, Dizziness, Headache, Myalgia, Diarrhea & NauseaVomiting Narrative: On 12/28/20 continue with headache, abdominal malaise, Dizziness. But referred is improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/23/2020,2.0,OTH,,,,,,"['Depression', 'Diarrhoea', 'Dizziness', 'Headache', 'Malaise', 'Myalgia', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 994231,,63.0,F,"Dizziness FLUSHED, HOT, DIPHURETIC, REDNESS, HEAVINESS IN STOMACH Narrative: RESOLVED IN 30 MINUTES",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Abdominal discomfort', 'Dizziness', 'Erythema', 'Feeling hot', 'Flushing', 'Hyperhidrosis']",1,MODERNA,IM 994232,,51.0,F,"Palpitations, Tachycardia, ""Woozy"", Lips itchy/dry Narrative: Noted patient checking her carotid pulse with her right hand as new band-aid being applied. Asked patient what was happening or wrong. Stated she felt her heart racing with palpitations. Requested assistance with vital sign monitoring. 15:18 Pulse 99 O2 sat 99% . States she continues to have tachycardia and palpitations and a bit ""woozy"". 15:19 Pulse 115, 99% O2 sat, BP 149/90 in right arm. States continues to have palpations and now a pain level of 4 in left lower anterior chest wall and lips are now itchy and dry. 50mg Benadryl given PO with water. 15:20 O2 sat 99% BP 142/87 pulse 89. States lips continue to be dry but less itchy and decrease in Left lower anterior chest wall pain. 15:25 O2 sat 99%, Pulse 86, BP 132/84. States lips continue to be dry no longer itchy, no further heart palpitations and decrease in Left lower anterior chest wall pain level 2 or 3 now 1530 O2 sat 100% Pulse 78. Alert oriented states feeling better. 1535 O2 sat 99% P 74 BP 111/69. States no further issues with lips. Chest wall pain now a level 1. 1545 O2 sat 99% P 74 BP 117/75. No further chest wall pain. All issues resolved. 1600 O2 sat 99%, P 73, BP 119/76. No pain. Patient stood, bent over, walked around no issues states feel normal with no issues.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Dizziness', 'Lip dry', 'Lip pruritus', 'Musculoskeletal chest pain', 'Palpitations', 'Tachycardia']",1,MODERNA,IM 994235,,46.0,F,"Headache, NauseaVomiting, fatigue Narrative: severe headache, severe fatigue, nausea; started 12/25/2020 at 04:00am lasted until 15:00pm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 994243,,53.0,F,Diarrhea Fatigue for 24 hours post vaccination. Loose stools were for 3 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,"['Diarrhoea', 'Fatigue']",1,PFIZER\BIONTECH,IM 994264,,53.0,F,Myalgia & Fever Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,unknown,,"['Myalgia', 'Pyrexia']",1,MODERNA,ID 994271,,53.0,F,"Sedation, Myalgia & Diarrhea Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Diarrhoea', 'Myalgia', 'Sedation']",1,MODERNA,IM 994279,,44.0,M,"Headache, Arthralgia, Phlebitis & Fever Narrative: ~ Discomfort 3-4/10 to include Injection site (Onset after ~6-8hours post injection); Headache, Feverish/Chills, Joint/Body Aches. Symptoms seemed to subside with tylenol, and Advil, reduced after approx 26-28hours post injection. Mild+ in nature. Additional pronounced Redness at injection site 1 1/2 to 2inches x 3 1/2 to 4inches reduced in size after ~ 4-5 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Injection site discomfort', 'Injection site erythema', 'Pain', 'Phlebitis', 'Pyrexia']",1,MODERNA,IM 994290,,60.0,M,"Myalgia 1) Arm stiffness, 2) Muscle soreness 3) Localized swelling 4) Small warm spot at injection site Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,OTH,,,,,,"['Injection site warmth', 'Musculoskeletal stiffness', 'Myalgia', 'Swelling']",1,MODERNA,IM 994297,,60.0,M,Fever fever Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,['Pyrexia'],1,PFIZER\BIONTECH,IM 994303,,36.0,F,"Headache, NauseaVomiting nausea, fatigue, brain fog, headache Narrative: Advised symptomatic management and follow-up with PCP as needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Fatigue', 'Feeling abnormal', 'Headache', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 997917,,55.0,F,"Dizziness, Tachycardia, tingling in upper and lower extremities Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Dizziness', 'Paraesthesia', 'Tachycardia']",1,MODERNA,IM 997918,,69.0,F,"Headache, Myalgia, CoughWheeze, Fatigue Narrative: Took OTC ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Cough', 'Fatigue', 'Headache', 'Myalgia', 'Wheezing']",1,MODERNA,IM 997919,,43.0,F,"SkinRash, Rash, UrticariaPruritus & NauseaVomiting Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Nausea', 'Pruritus', 'Rash', 'Urticaria', 'Vomiting']",1,MODERNA,IM 997920,,63.0,M,"Headache, Myalgia, Pain at injection site, then fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Injection site pain', 'Myalgia']",1,PFIZER\BIONTECH,IM 997921,,61.0,F,"Rash Narrative: reports onset of rash 8 days post injection, localized around area of injection site. red, slightly raised, skin intact.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,OTH,,,,,,"['Injection site rash', 'Rash erythematous', 'Rash papular']",1,MODERNA,IM 997922,,50.0,M,"Headache, Diarrhea, NauseaVomiting, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Diarrhoea', 'Fatigue', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA, 997924,,41.0,F,Myalgia fatigue. redness and itchy at the injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Fatigue', 'Injection site erythema', 'Injection site pruritus', 'Myalgia']",UNK,MODERNA, 997929,,52.0,F,"Dizziness, Myalgia, NauseaVomiting, Palpitations, swollen lymph nodes in neck, SOB",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Dizziness', 'Dyspnoea', 'Lymphadenopathy', 'Myalgia', 'Nausea', 'Palpitations', 'Vomiting']",UNK,MODERNA, 997934,,52.0,F,UrticariaPruritus Narrative: Employee self treating with benadryl. It started on 1/5/21,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,OTH,,,,,,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 997947,,43.0,F,"SkinRash, Rash & UrticariaPruritus",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,OTH,,,,,,"['Pruritus', 'Rash', 'Urticaria']",1,MODERNA,SC 997953,,38.0,F,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 997958,,54.0,M,"muscle weakness, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Fatigue', 'Muscular weakness']",1,MODERNA,IM 997964,,73.0,F,"Rash, UrticariaPruritus, itchy, redness, hardened area that is growing Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Erythema', 'Induration', 'Rash pruritic', 'Urticaria']",1,MODERNA,IM 997970,,53.0,M,"fingers tingling, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Fatigue', 'Paraesthesia']",1,MODERNA,IM 997977,,44.0,F,"Headache, NauseaVomiting, HA, nausea, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Fatigue', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 997983,,41.0,F,"Headache HA (migraine), pain at injection site Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Injection site pain', 'Migraine']",1,MODERNA,IM 997989,,37.0,F,"Headache, Myalgia, felt warm-feverish Narrative: Taking OTC NyQuil every 4-6 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,,,,yes-Influenza vaccine-has cold-like symptoms,,"['Feeling hot', 'Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 997999,,31.0,F,Headache Narrative: Mild headache started 2 minutes after injection,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,['Headache'],1,PFIZER\BIONTECH,IM 998008,,73.0,M,"Hx. DM. Noted during observation he was forgetful but able to verbalize but speech noted to slur, Juice given 120/90, 78, 18. c/o of tightness in chest and was transported to ED for evaluation in stable condition. 140/78, 68, 18. Acu chceck 240 in ED. Di Narrative: After vaccine, during observation seemed forgetful but able to verbalize. Speech noted to slur, History of DM verbalized by pt. Juice given 120/90, 78, 18. c/o of tightness in chest and was transported to ED for evaluation in stable condition. 140/78, 68, 18. Acu chceck 240 in ED. Discharged asymptomatic from ED to f/u with PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,OTH,,,,,,"['Chest discomfort', 'Dysarthria', 'Memory impairment']",1,PFIZER\BIONTECH,IM 998015,,61.0,F,Dizziness Narrative: Dizzy 10 minutes after injection,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 998020,,36.0,F,Dizziness Narrative: Dizzy approximately 2-3 minutes after vaccine injection,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 998027,,62.0,F,Injection site soreness Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,['Injection site pain'],1,PFIZER\BIONTECH,IM 998034,,64.0,F,Flushing Narrative: Flushing 10 minutes after vaccine administration,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,['Flushing'],1,PFIZER\BIONTECH,IM 998050,,48.0,M,Headache Lightheadedness Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Dizziness', 'Headache']",1,PFIZER\BIONTECH,IM 998057,,43.0,F,Rash & UrticariaPruritus Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,OTH,,,,,,"['Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 998064,,60.0,F,"Myalgia right arm red, warm, raised area. Itchy with moderate firmness Narrative: Vaccine on 12/23/2020, Right arm warm, red area 3 inches in diameter, Itchy, moderate firmness (less firm than a few days ago). Sore, has psoriasis on elbow, has not missed work. Temp 97.2",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,OTH,,,,,,"['Erythema', 'Induration', 'Myalgia', 'Pruritus', 'Psoriasis', 'Skin warm']",1,MODERNA,IM 998117,,47.0,F,Face and neck flushing and tingling. Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Flushing', 'Paraesthesia']",1,MODERNA,IM 1000713,,41.0,M,Dizziness Flushed. Buzzing in ears.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Dizziness', 'Flushing', 'Tinnitus']",1,MODERNA,IM 1000714,,64.0,F,Fever pain at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Injection site pain', 'Pyrexia']",1,MODERNA,IM 1000715,,46.0,F,"Headache, Fever, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Chills', 'Headache', 'Pyrexia']",1,MODERNA,IM 1000716,,53.0,M,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 1000717,,50.0,F,"Right upper quadrant dull pain 4/10 around the liver area, has not checked liver enzymes Narrative: has not seeked medical care",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/26/2020,4.0,OTH,,,,,,"['Abdominal pain upper', 'Hepatic pain', 'Pain']",1,PFIZER\BIONTECH,IM 1000718,,42.0,M,"Headache, Myalgia & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia', 'Nausea', 'Vomiting']",UNK,MODERNA, 1000719,,40.0,F,"Myalgia, Fever, noticed sore arm this AM (1/6/21) then myalgias and fever this afternoon to 101.1, now 100.6 and tingling feeling all over",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Myalgia', 'Pain in extremity', 'Paraesthesia', 'Pyrexia']",1,MODERNA,IM 1000720,,40.0,F,Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,OTH,,,,,,['Pyrexia'],1,MODERNA,IM 1000769,,69.0,M,"Headache, Myalgia & Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/03/2021,3.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 1000772,,50.0,F,"Headache, Myalgia & Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 1000810,,63.0,M,"Headache, Myalgia, Fever & Diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Diarrhoea', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 1000813,,38.0,M,"Rash, Purpura, ""Spotty skin discoloration (slight reddish/purple color) down the arm L > R, Pain at injection site""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,,,,unknown,,"['Purpura', 'Rash', 'Skin discolouration']",1,PFIZER\BIONTECH,IM 1000816,,54.0,F,"""Lightheaded"", ""woozy"", ""stressed that may play a role"" @ 1524 BP 168/100 HR 68 SPO2 97% RA, @1527 BP 161/87, @1532 BP 158/84, @1538 BP 151/97 Narrative: Report provided to this RN by staff, monitor post Covid vaccination: @1524 (Post 15 min monitoring after receiving vaccination) Employee reported to staff, monitor, a mild feeling of being lightheaded or ""woozy"" and stated "" have been a bit stressed regarding news and uncertain if that is playing a role, vitals were taken. Employee agreed to stay for another 15 mins, @1538 last BP taken and Employee stated she felt better. Symptoms resolved and employee was able to go.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Dizziness', 'Stress']",1,PFIZER\BIONTECH,IM 1000825,,47.0,F,"Headache, Myalgia, sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/06/2021,6.0,OTH,,,,,,"['Headache', 'Myalgia', 'Oropharyngeal pain']",1,MODERNA,IM 1000835,,50.0,F,NauseaVomiting Chills,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Chills', 'Nausea', 'Vomiting']",1,MODERNA,IM 1000837,,29.0,F,"Chills, dizzy, headache, injection site pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Dizziness', 'Headache', 'Injection site pain']",1,PFIZER\BIONTECH,IM 1000838,,55.0,F,UrticariaPruritus Infection site red and warm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/06/2021,6.0,OTH,,,,,,"['Injection site erythema', 'Injection site warmth', 'Pruritus', 'Urticaria']",UNK,MODERNA, 1000839,,55.0,M,"Myalgia, Fever, Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pyrexia']",UNK,MODERNA, 1000841,,43.0,F,"Myalgia Swollen glands (armpits and neck), Injection site warm and red",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/06/2021,9.0,OTH,,,,,,"['Injection site erythema', 'Injection site warmth', 'Lymphadenopathy', 'Myalgia']",UNK,MODERNA, 1000842,,62.0,F,"Confusion, Headache, Myalgia, Arthralgia, Diarrhea & NauseaVomiting Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,OTH,,,,,,"['Arthralgia', 'Confusional state', 'Diarrhoea', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",UNK,MODERNA, 1000845,,56.0,M,"Headache, Myalgia, Arthralgia, NauseaVomiting, Chills, Shaking Cold, Fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",UNK,MODERNA, 1000846,,27.0,F,"Red, swollen injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,OTH,,,,,,"['Injection site erythema', 'Injection site swelling']",UNK,MODERNA, 1000848,,46.0,F,"Headache, UrticariaPruritus, Arm pain with urticarial rash Narrative: Given antibiotic with what appears localized infection area",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/01/2021,4.0,OTH,,,,,,"['Headache', 'Localised infection', 'Pain in extremity', 'Pruritus', 'Urticaria']",1,MODERNA,IM 1000850,,69.0,M,"Headache, Bradycardia, FLUSHING, TINGLING OF LOWER EXTREMITIES, GENERALIZED WEAKNESS Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Asthenia', 'Bradycardia', 'Flushing', 'Headache', 'Paraesthesia']",UNK,MODERNA, 1000851,,61.0,M,"Headache, Myalgia, Arthralgia, Fever, very fatigued Narrative: Temp was 98.7F",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1000853,,47.0,F,"Myalgia, Fever, UrticariaPruritus, Anorexia, SOA, rhinorrhea, chills, Narrative: Self treated with Benadryl and motrin",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/03/2021,1.0,OTH,,,,,,"['Chills', 'Decreased appetite', 'Joint swelling', 'Myalgia', 'Pruritus', 'Pyrexia', 'Rhinorrhoea', 'Urticaria']",UNK,PFIZER\BIONTECH,IM 1000855,,59.0,F,Headache & Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 1000939,,52.0,F,Dizziness tingling around lips Narrative: took Benadryl,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Dizziness', 'Paraesthesia oral']",1,MODERNA, 1001018,,61.0,M,"Headache, SkinRash, Sweating, thigh rash and headache Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Hyperhidrosis', 'Rash']",1,PFIZER\BIONTECH,IM 1001034,,59.0,M,"Headache, Diarrhea, Low grade fever, body aches, fatigue Narrative: Developed a low grade fever, fatigue, body aches, headache, lightheadedness, and diarrhea following vaccine administration. Resolved by 12/30/20.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1001038,,54.0,M,"pain at injection site, tired, malaise, generalized pain, nausea, runny nose Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Fatigue', 'Malaise', 'Nausea', 'Pain', 'Pain in extremity', 'Rhinorrhoea']",1,PFIZER\BIONTECH,IM 1001042,,61.0,F,"Low grade fever, fatigue, body aches, arm pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,OTH,,,,,,"['Fatigue', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1001075,,30.0,F,Diarrhea & NauseaVomiting Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,,,,,,"['Diarrhoea', 'Nausea', 'Vomiting']",1,MODERNA,IM 1001105,,56.0,F,"Headache, Myalgia, NauseaVomiting, Chills/ Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 1001108,,50.0,M,"Headache, NauseaVomiting, Arm soreness at injection site, neck tightness Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Headache', 'Muscle tightness', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 1001177,,49.0,F,"Headache chills, feels hot (no fever), body aches, stuffiness, and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,OTH,,,,,,"['Chills', 'Feeling hot', 'Headache', 'Pain', 'Respiratory tract congestion']",1,PFIZER\BIONTECH,IM 1001231,,49.0,M,"Headache, Myalgia, Arthralgia & Fever Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 1001232,,47.0,F,Fever Narrative: Reports temp of 101.1 overnight,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Pyrexia'],1,MODERNA,IM 1001234,,45.0,F,"Headache NASAL DRAINAGE, HEADACHE, FLUSHING, CHILLS, FATIGUE Narrative: ABOUT 30 MIN. AFTER VACCINATION, PATIENT BEGAN TO FEEL OFF-BALANCED WITH A MILD HEADACHE ABOVE THE RIGHT EYE. FOREHEAD WAS FLUSHED, WATERY EYES, RUNNY NOSE, FATIGUE AND CHILLS. LEFT UPPER ARM IS SORE, MORE NOTICEABLE WITH MOVEMENT. AT TIME OF REPORT, PATIENT CONTINUES TO HAVE RIGHT SIDED HEADACHE, SORE UPPER ARM, CHILLS AND FATIGUE.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Balance disorder', 'Chills', 'Fatigue', 'Flushing', 'Headache', 'Injection site pain', 'Lacrimation increased', 'Pain', 'Rhinorrhoea']",1,MODERNA,IM 1001236,,47.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 1001237,,51.0,F,"Headache, Fever, HEADACHE, FEVER, CHILLS, FATIGUE Narrative: AROUND 6PM ON DAY OF VACCINATION, CHILLS AND FEVER (101.8/101.9 F), LIGHT HEADACHE WITH EXTREME FATIGUE. TREATED WITH TYLENOL ON 1/4/21 AND 1/5/21; STILL FATIGUE ON 1/6/21 BUT NO FEVER (LAST TYLENOL 7 PM ON 1/5/21)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pyrexia']",1,MODERNA,IM 1001239,,49.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 1001240,,39.0,M,Myalgia fatigue for 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Fatigue', 'Myalgia']",UNK,MODERNA, 1001241,,41.0,M,Headache & Diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Diarrhoea', 'Headache']",1,PFIZER\BIONTECH,IM 1001242,,29.0,M,Tachycardia Narrative: 0758 employee c/o what felt like increased heart rate and then slowed down. Employee stated that he did not eat in AM. VS: T96.8; 120/75; 61; 96% RA. Employee reclined back with feet up an given cranberry juice. 0820 employee stated he felt better after cranberry juice. VS: T96.4 133/79; 54; 96% RA.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Heart rate increased', 'Tachycardia']",1,MODERNA,IM 1001377,,33.0,F,"Dizziness, Headache, NauseaVomiting, parasthesia Narrative: pt reported numbness in LUE where shot was given, lightheadedness, nausea, was moved to lying position. Patient o2 sat 97%, 2L NC o2 applied for comfort. Patient voided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/06/2021,,OTH,,,,,,"['Dizziness', 'Headache', 'Injection site hypoaesthesia', 'Nausea', 'Vomiting']",1,MODERNA,IM 1004926,,64.0,F,"Dizziness, HYPERtension & Tachycardia Narrative: 5 min after vaccine administered L arm felt dizzy. 170/100, HR 133, 97% RA at 1220. Reported poor sleep and mild anxiety. 115/76, HR 116, 96% RA at 1234. At 1237 denies any dizziness or other adverse effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Anxiety', 'Dizziness', 'Hypertension', 'Poor quality sleep', 'Tachycardia']",1,PFIZER\BIONTECH,IM 1004944,,64.0,M,malaise,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,['Malaise'],1,MODERNA,IM 1004954,,61.0,M,"Headache, Myalgia, Arthralgia, Fever, chills, fatigue, diarrhea Narrative: Employee received vaccine on 01/04/2021 and did not experience symptoms until the following day. On 01/05/2021, employee began experiencing fever (100 F), chills, headache, joint and muscle aches, fatigue, and diarrhea. Of note, employee reports attended a football game on 12/26/2020. Reports using Dayquil and Nyquil currently for symptoms. Symptoms have not yet resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 1004997,,41.0,F,"Headache, Myalgia, malaise, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Chills', 'Headache', 'Malaise', 'Myalgia']",1,MODERNA,IM 1004998,,64.0,F,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 1005140,,41.0,M,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,,,,,,"['Headache', 'Myalgia']",2,PFIZER\BIONTECH,IM 1005157,,68.0,M,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 1005168,,47.0,M,"Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA, 1005235,,45.0,F,"SkinRash c/o itchiness of the lower back with redness noted on lower back and the forehead (between the eyebrows). Hx. seasonal and alcohol allergies that present with rash Narrative: c/o itchiness of the lower back. redness noted on the lower back and the forehead (between the eyebrows). No sob. states hx/seasonal and alcohol allergies that present with rashes. Benadryl given @ 1650: 156/86, 86, 95%O2sat. @ 1700: 163/89, 81, 97%O2sat; @1720: 163/89, 91, 98% O2sat. 1720 redness diminishing, redness to forehead almost gone. In good spirits and denies sob. D'c'd stable to home with friend to escort. Going home, husband home, per pt.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Erythema', 'Pruritus', 'Rash', 'Skin irritation']",1,PFIZER\BIONTECH,IM 1005538,,55.0,F,Myalgia CHILLS Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Chills', 'Myalgia']",UNK,MODERNA, 1005554,,57.0,M,Myalgia FATIGUE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Fatigue', 'Myalgia']",UNK,MODERNA, 1005574,,44.0,F,"Myalgia malaise. Inidially following injection, she had red face, hot & stayed 1 hour. During the a.m., earlier same day she had an MRI w/contrast. Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,,,,,,"['Erythema', 'Feeling hot', 'Immediate post-injection reaction', 'Malaise', 'Myalgia']",1,MODERNA,IM 1005577,,50.0,F,Rash LARGE RED AREA AT SITE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/08/2021,9.0,OTH,,,,,,"['Injection site erythema', 'Rash']",1,MODERNA,IM 1005586,,30.0,M,"Dizziness c/o feeling warm and dizzy w/ diaphoretic skin. Recovered after cold pack to neck and monitoring for 30 min. Narrative: 7 min after vaccine, c/o feeling warm and dizzy. Skin diaphoretic and pale. unlabored breathing. @1308: 98/54, 76, 96% O2 sat.; @1316: 122/66, 92, 20, 95% O2sat and stated feeling better. Observed for 30 minutes and d/c'd in stable condition. ambulated around the room and denied any c/o prior to D/C. Resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Dizziness', 'Feeling hot', 'Hyperhidrosis', 'Pallor']",1,PFIZER\BIONTECH,IM 1005588,,54.0,M,Myalgia chills Narrartive:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Chills', 'Myalgia']",UNK,MODERNA, 1005590,,62.0,F,"c/o mild itching. 132/78, 78, 18, 99% O2 sat. Narrative: After vaccine c/o mild itching. Cetirizine given PO. Observed 30 min. @ 1340: 132-78, 78, 18m 99% O2 sat. Feeling better. D/C'd stable",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,['Pruritus'],1,PFIZER\BIONTECH,IM 1005591,,57.0,F,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia']",UNK,MODERNA, 1005592,,60.0,F,"c/o itching and pressure in her head. Narrative: c/o of itching and pressure in head. Staff gave Diphenhydramine HCL VS 178/85, 72, 18, 98% O2sat. at 1340 states she felt better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Head discomfort', 'Pruritus']",2,PFIZER\BIONTECH,IM 1005597,,58.0,M,nasal congestion Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/06/2021,6.0,OTH,,,,,,['Nasal congestion'],UNK,MODERNA, 1005599,,66.0,M,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,OTH,,,,,,['Unevaluable event'],1,MODERNA,IM 1005600,,54.0,M,"Headache, Fever, chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Chills', 'Headache', 'Pyrexia']",1,MODERNA,IM 1005601,,57.0,F,"Myalgia Chills, arm pain Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,,,,,,"['Chills', 'Myalgia', 'Pain in extremity']",1,MODERNA,IM 1005605,,64.0,F,"Fatigue Narrative: Went to work for a few minutes -- really tired. Fellow employee said she should go home or be reported. First shot had a sore arm & a bit of a cold for a few hours and back to work. This time has sore arm and is more tired than usual. 98.7 F No cough, HA, N/V. No medications taken for s/e.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,,,,,,"['Fatigue', 'Impaired work ability', 'Nasopharyngitis', 'Pain in extremity']",UNK,PFIZER\BIONTECH,IM 1005608,,63.0,F,"Dizziness, Fever, Tachycardia, lightheaded Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,OTH,,,,,,"['Dizziness', 'Pyrexia', 'Tachycardia']",1,MODERNA,IM 1005613,,65.0,M,Myalgia & Fever Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Myalgia', 'Pyrexia']",1,MODERNA,IM 1005618,,43.0,F,"Headache, Sedation, Myalgia, Arthralgia, WEAKNESS, CHILLS BUT NO FEVER Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Arthralgia', 'Asthenia', 'Chills', 'Headache', 'Myalgia', 'Sedation']",1,MODERNA,IM 1005630,,60.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 1011323,,46.0,M,"c/o tingling in both hands, light headed, profuse sweating and color pale. 120/68, 83, 28, 98%O2 sat. T 97.7 Narrative: c/o tingling to both hands, light headedness, profuse sweating, and color pale. 120/68, 83, 28, 98%O2 sat.; 122/62, 84, 24, 98% O2sat.; 119/60, 82, 20, 97% O2sat. ; at discharge 125/88, 78, 18, 98% O2 sat.. 09500: Recovered and ""feeling better.""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,11/22/2020,12/21/2020,29.0,OTH,,,,,,"['Dizziness', 'Hyperhidrosis', 'Pallor', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 1011340,,51.0,M,"Headache, NauseaVomiting, R arm red, hot, & hard. Sinus drainage. Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Erythema', 'Headache', 'Induration', 'Nausea', 'Paranasal sinus hypersecretion', 'Skin warm', 'Vomiting']",1,MODERNA,IM 1011342,,,F,"Headache, Myalgia & Fever Narrative: 0830 immunization. 2200. Shivering so bad she couldn't fall asleep until 03:00. Then sweats. Real bad sweats. Aches & pains all over. Bad retro-orbital headache. T-max 100.0 First dose in series had only significant local soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Chills', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Pain', 'Pyrexia', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 1011343,,60.0,F,"Headache, Sedation, Myalgia, Arthralgia, Tender lymph nodes under arm and neck",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Lymph node pain', 'Myalgia', 'Sedation']",1,MODERNA,IM 1011344,,53.0,F,"Dizziness, HYPERtension, Syncope, Tachycardia, DIZZINESS AND LIGHTHEADED NESS AFTER VACCINE THIS AM AROUND 8:30. AT 12:30, WAS VERY PALE, WARM, DRY AND FEELING FAINT. 165/87, 104, 96.2, 98%, BLOOD GLUCOSE 158. NO SOB, RASH, OR ITHCING. AFTER 30 MINUTES WAS 112/69, 73, 18, 98%. Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,,,,,,"['Blood glucose normal', 'Dizziness', 'Dry skin', 'Hypertension', 'Pallor', 'Skin warm', 'Syncope', 'Tachycardia']",1,MODERNA,IM 1011345,,66.0,F,"Flu like symptoms headaches, chills, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/08/2021,2.0,OTH,,,,,,"['Chills', 'Headache', 'Influenza like illness', 'Nausea']",1,MODERNA,IM 1011355,,52.0,M,Flu like symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/08/2021,2.0,OTH,,,,,,['Influenza like illness'],1,MODERNA,IM 1011405,,55.0,F,"Headache fatigue, sore throat Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/30/2020,8.0,OTH,,,,,,"['Fatigue', 'Headache', 'Oropharyngeal pain']",1,PFIZER\BIONTECH,IM 1011501,,45.0,M,SkinRash injection site pain and swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Injection site pain', 'Injection site swelling', 'Rash']",1,PFIZER\BIONTECH,IM 1011521,,36.0,F,SkinRash 2 days after vaccine onset of painful skin rash 2 inches below deltoid Narrative: Mildly painful rash two inches below deltoid,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/31/2020,3.0,OTH,,,,,,['Rash'],UNK,MODERNA,IM 1011565,,47.0,M,"Headache, Arthralgia, NauseaVomiting, chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 1011617,,37.0,F,"Headache, Myalgia & Arthralgia Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Myalgia']",1,PFIZER\BIONTECH,IM 1011637,,47.0,F,"Hypertension + chostochondritis left ribs 1-3 Narrative: Patient reported slightly elevated BP at 143/93 and reproducible chest pain on 1/8/2021 at 9:00am. Wanted to be examined as her 2 year boyfriend recently died of an arrhythmia. Has history of fibromyalgia and BP is ""always is elevated when she see's a provider"". BP improved to 138/76 on repeat after 15 min of discussion.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/08/2021,4.0,OTH,,,,,,"['Blood pressure increased', 'Chest pain', 'Condition aggravated', 'Costochondritis', 'Hypertension']",1,MODERNA,IM 1012028,,66.0,M,"Light-headedness Narrative: Pt on 15min observation and complained of being lightheaded; BP taken at 1606, BP 120/80; pt was observed for another 15mins; VS taken at 1623, BP 102/62, HR 71, 02Sat 100%; pt states she is feeling better and ready to go home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,['Dizziness'],2,PFIZER\BIONTECH,IM 1012056,,39.0,F,"SkinRash & UrticariaPruritus Narrative: Patient reports an itchy rash from head to toe starting night of injection, missed work",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Impaired work ability', 'Pruritus', 'Rash', 'Rash pruritic', 'Urticaria']",1,MODERNA,IM 1012058,,53.0,M,"Headache, Myalgia & Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 1012059,,52.0,F,Fever COVID diagnosis 12/27/2020,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/27/2020,4.0,OTH,,,,,,"['COVID-19', 'Pyrexia']",1,MODERNA,IM 1012060,,49.0,F,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 1012062,,65.0,F,"Dizziness, Headache, Myalgia, ErythemaMultiform, L arm pain,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Dizziness', 'Erythema multiforme', 'Headache', 'Myalgia', 'Pain in extremity']",1,MODERNA,IM 1012063,,35.0,F,"Headache, Myalgia, Arthralgia, NauseaVomiting, chills, sweats",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 1012064,,53.0,F,"Headache, Myalgia, Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia']",UNK,PFIZER\BIONTECH, 1012065,,33.0,F,"ErythemaMultiform, UrticariaPruritus, 12/31-1/1 site redness and swelling, sore faded away. then returned on 1/6 red, swollen, itchy felt like big bug bite 1/7 hardened large circle swollen, erythema, itchy, dull pain. Narrative: 12/31-1/1 site redness swelling, sore faded away. then returned on 1/6 red, swollen, itchy felt like big bug bite 1/7 hardened large circle swollen, erythema, itchy, dull pain. Takes Flonase everyday, ice applied 1/6 with some relief.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,,,,"yes, HPV adverse rxn fainted in 2004",,"['Erythema multiforme', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Pruritus', 'Urticaria']",1,MODERNA,IM 1012066,,58.0,F,"fatigue, left tongue swelling, night sweats Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Fatigue', 'Night sweats', 'Swollen tongue']",1,MODERNA,IM 1012067,,51.0,F,"SkinRash chills, sore throat, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/07/2021,2.0,OTH,,,,,,"['Chills', 'Oropharyngeal pain', 'Pain', 'Rash']",1,MODERNA,IM 1012071,NY,65.0,M,"Narrative: Symptoms: Headache, Myalgia, NauseaVomiting & body ache Treatment:",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/05/2021,5.0,OTH,,,,,,"['Headache', 'Myalgia', 'Nausea', 'Pain', 'Vomiting']",UNK,MODERNA, 1012077,MS,70.0,M,"Narrative: Patient received vaccination on 12/31/ 2020 and reports on 1/6/2021 that he had vivid dream/hallucination approximately the next evening after receiving vaccination and then reports having another vivid dream/hallucination on the 3rd day post-vaccination. Pt did not receive any treatment medication for vivid dream/hallucination. Pt does not have any noted history of hallucinations in the past. Current orders in place by provider: Labs, UA/ C&S, I&O Q4H, NEURO CHECK Q4H, VS Q4H. PMH: recurrent major depressive disorder, adjustment disorder with depressed mood. Symptoms: Hallucinations & VIVID DREAM Treatment:",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/01/2021,1.0,OTH,PPD 12/23/2020,,,,,"['Abnormal dreams', 'Hallucination']",2,MODERNA, 1015725,,41.0,M,"Reported numbness in lips and L Malar area; no angioedema Narrative: Employee was taken to facility in wheelchair, evaluated and stable. Diagnosis vasovagal due to needle anxiety vs mild allergic reaction to MODERNA vaccine. Given 50mg Benadryl and Solumedrol 125mg IM. Monitored for 30 minutes, completely asymptomatic. Release home in care of wife.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Hypersensitivity', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Immunisation anxiety related reaction', 'Presyncope']",1,MODERNA,IM 1015726,,50.0,F,"Fever Facial tingling, blue nailbeds Narrative: Facial tingling resolved. Still has low grade fever, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Fatigue', 'Nail discolouration', 'Paraesthesia', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 1015727,,39.0,F,Headache Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Headache'],1,PFIZER\BIONTECH,IM 1015728,,60.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Headache'],1,PFIZER\BIONTECH,IM 1015729,,46.0,F,"Dizziness, NauseaVomiting, right arm mild soreness Narrative: 12/29 employee reports onset of dizziness and nausea about 2 hours after the vaccine. Her right arm is slightly sore. 12/30 - symptoms have improved and are very slight today. 12/21 resolution of all symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Dizziness', 'Nausea', 'Pain in extremity', 'Vomiting']",1,PFIZER\BIONTECH,IM 1015800,,54.0,F,"Headache, Sedation, fatige",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Sedation']",1,PFIZER\BIONTECH,IM 1015807,,48.0,F,Myalgia & Fever Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Myalgia', 'Pyrexia']",UNK,MODERNA,IM 1015815,,59.0,M,Headache sore right arm Narrative: Reported headache and sore right arm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Headache', 'Pain in extremity']",1,MODERNA,IM 1015822,,89.0,M,Myalgia & CoughWheeze,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/25/2020,3.0,OTH,,,,,,"['Cough', 'Myalgia', 'Wheezing']",2,MODERNA, 1015823,,72.0,M,Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/24/2020,2.0,OTH,,,,,,['Pyrexia'],2,MODERNA, 1015824,,37.0,M,Headache Narrative: Reported headache,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,OTH,,,,,,['Headache'],1,MODERNA,IM 1015825,,63.0,M,Rash,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,01/05/2021,14.0,OTH,,,,,,['Rash'],2,MODERNA, 1015827,,38.0,F,"Headache, Myalgia, Arthralgia, Fever, Diarrhea & NauseaVomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,yes; H1N1 flu vaccine gave a 103 fever,,"['Arthralgia', 'Diarrhoea', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA, 1015828,,53.0,M,Headache Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache']",UNK,MODERNA, 1015829,,66.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Headache'],UNK,MODERNA, 1015830,,36.0,F,Myalgia FATIGUE Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Fatigue', 'Myalgia']",UNK,MODERNA, 1015831,,69.0,M,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,['Headache'],UNK,MODERNA, 1015832,,54.0,F,"Dizziness, NauseaVomiting, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Dizziness', 'Fatigue', 'Nausea', 'Vomiting']",1,MODERNA,IM 1015833,,39.0,M,"Headache, Myalgia, Fever, chills, day after fatigue and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1015857,,60.0,F,"Headache very fatigue, soreness at injection site Narrative: stayed home from work",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Impaired work ability', 'Injection site pain']",1,PFIZER\BIONTECH,IM 1016012,,53.0,F,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 1016019,,53.0,F,Myalgia chills Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Myalgia']",UNK,MODERNA, 1016248,,47.0,F,"Headache, Myalgia, Arthralgia, NauseaVomiting, Fatigue, pain/swelling of injection site Narrative: Swelling/pain/tenderness at injection site starting 6-7 hours after vaccination, continuing for 3-4 days. Headache, body aches, nausea and fatigue starting 24 hours after vaccination (all continued for 3-4 days). At time of report (8 days post vaccination), still complains of headache and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,Headache/myalgia/arthralgia from season influenza vaccines,,"['Arthralgia', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,IM 1016283,,62.0,F,Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 1016286,,67.0,M,shoulder pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Arthralgia'],UNK,MODERNA, 1016287,,43.0,M,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,12/27/2020,1.0,OTH,,,,,,['Unevaluable event'],UNK,PFIZER\BIONTECH,IM 1016291,,31.0,F,Redness and swelling at injection site Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/07/2021,9.0,OTH,,,,,,"['Injection site erythema', 'Injection site swelling']",UNK,MODERNA, 1016292,,57.0,F,"Diarrhea, Palpitations, Tachycardia, Fatigue; Tachycardia;Generalized weakness Narrative: Fatigue; Tachycardia;Generalized weakness- trasfered to ER-Benadryl 25 mg IVP. recovered after 1 hr of benadryl. 12/31-mild discomfort at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Asthenia', 'Diarrhoea', 'Fatigue', 'Injection site discomfort', 'Palpitations', 'Tachycardia']",1,MODERNA,IM 1016293,,72.0,F,Dizziness hot flashes Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Dizziness', 'Hot flush']",1,MODERNA,IM 1016294,,59.0,F,Weakness upper arm bilaterally,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,,,,,,['Muscular weakness'],1,MODERNA,IM 1016298,,45.0,F,"Headache, Myalgia, Arthralgia, Rash, Deltoid painful couple of days, fatique",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,"yes, Reports muscle pain 4-5 days after Tetanus vaccine",,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Rash']",1,MODERNA,IM 1016300,,43.0,F,"Headache, Myalgia, Fever, pain, redness, and itching at the injection site Narrative: fever was 100.1; resolved within 24 hours headache resolved within 24 hours pain at injection site resolved, but redness and itching persist",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,OTH,,,,,,"['Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Myalgia', 'Pyrexia']",UNK,MODERNA,IM 1016312,,52.0,F,"Headache, Myalgia, Unable to sleep due to left arm pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Insomnia', 'Myalgia', 'Pain in extremity']",1,MODERNA,IM 1016318,,35.0,F,"Headache, Myalgia, Fever, chills, loss of taste Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,"['Ageusia', 'Chills', 'Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1016331,,59.0,M,Headache Fatigue Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,OTH,,,,,,"['Fatigue', 'Headache']",1,MODERNA,IM 1016341,,56.0,M,"Headache, Myalgia, Fever, Chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chills', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA, 1016380,,52.0,F,Headache & Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia']",UNK,MODERNA, 1016466,,70.0,F,Fever Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,OTH,,,,,,['Pyrexia'],1,PFIZER\BIONTECH,IM 1016500,,56.0,F,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 1016520,,62.0,M,Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,['Myalgia'],UNK,MODERNA, 1016583,,61.0,F,"UrticariaPruritus injection site - edema, warmth Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/27/2020,5.0,OTH,,,,,,"['Injection site oedema', 'Injection site warmth', 'Pruritus', 'Urticaria']",1,MODERNA, 1016685,,46.0,F,"Headache, Myalgia, Diarrhea, stomach ache Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Abdominal pain upper', 'Diarrhoea', 'Headache', 'Myalgia']",UNK,MODERNA, 1019865,,49.0,F,"Headache, Myalgia, Arthralgia, chills, malaise Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Malaise', 'Myalgia']",1,MODERNA,IM 1019871,,38.0,F,Headache & Myalgia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia']",UNK,MODERNA, 1019878,,45.0,F,"Dizziness, Headache, Arthralgia, chest tightness, sensation of throat swelling, subjective fever, dry mouth, anxiety Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Anxiety', 'Arthralgia', 'Chest discomfort', 'Dizziness', 'Dry mouth', 'Headache', 'Pharyngeal swelling', 'Pyrexia']",1,MODERNA,IM 1019884,,56.0,M,"Myalgia, Fever, Fatigue, reports that fever up to 101, drops to 100.8 with Tylenol Extra strength.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Fatigue', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1019932,,45.0,M,"Confusion, Headache, Myalgia, Arthralgia, Swelling and pain at the injection site, fatigue, tingling, feeling of heat in feet, chest tightness, eye pain Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Arthralgia', 'Chest discomfort', 'Confusional state', 'Eye pain', 'Fatigue', 'Feeling hot', 'Headache', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Paraesthesia']",UNK,MODERNA, 1019945,,54.0,M,Headache stuffy nose Narrative: Patient stated he received his Covid vaccination on Monday 1/4/2021. States he has stuffy nose and headache. States he missed work today 1/7/2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/07/2021,3.0,OTH,,,,,,"['Headache', 'Impaired work ability', 'Nasal congestion']",1,MODERNA,IM 1019981,,60.0,M,"Fever L arm pain, nasal congestion/runny, chills, burning in chest, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Chest pain', 'Chills', 'Fatigue', 'Nasal congestion', 'Pain in extremity', 'Pyrexia', 'Rhinorrhoea']",UNK,MODERNA, 1019992,,39.0,F,"Headache, Myalgia, Arthralgia, Fever, Rash, NauseaVomiting, Nausea, fatigue, sore throat, tongue edema, fever, rash",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Pyrexia', 'Rash', 'Tongue oedema', 'Vomiting']",UNK,MODERNA,IM 1020089,,58.0,F,"Headache, Myalgia, Arthralgia & Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,,,,,,"['Arthralgia', 'Headache', 'Myalgia', 'Pyrexia']",UNK,MODERNA,IM 1020098,,57.0,F,Headache & Myalgia Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Headache', 'Myalgia']",1,MODERNA,IM 1020123,,53.0,F,"Headache, Myalgia, Fever, NauseaVomiting, Uncontrolled shivering, fatigue, shortness of breath,soreness at injection site, fever 99.9-103 for 2 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 1020128,,41.0,M,"Headache, Arthralgia, Fever, weakness; injection site pain, chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,,,,,,"['Arthralgia', 'Asthenia', 'Chills', 'Headache', 'Injection site pain', 'Pyrexia']",1,MODERNA,IM 1022803,,40.0,M,Dizziness Fatigue Narrative: Patient developed vertigo and general fatigue following administration of covid vaccine. Resolved as of 1/5/21.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Dizziness', 'Fatigue', 'Vertigo']",1,PFIZER\BIONTECH,IM 1023059,,24.0,F,NauseaVomiting low grade fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,OTH,,,,,,"['Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 1023068,,56.0,F,"Headache, Myalgia, Arthralgia, fatigue, injection site pain Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia']",1,PFIZER\BIONTECH,IM 1023089,,27.0,F,"NauseaVomiting Aggravation of POTS, dizziness, fever, nausea, muscle aches and pain Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Condition aggravated', 'Dizziness', 'Myalgia', 'Nausea', 'Pain', 'Postural orthostatic tachycardia syndrome', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 1023092,,56.0,F,SkinRash & Rash,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,OTH,,,,,,['Rash'],1,MODERNA,IM 1023095,,26.0,F,SkinRash localized skin rash at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,OTH,,,,,,['Injection site rash'],1,MODERNA, 1023096,,55.0,F,"SkinRash Vaccinated with 2nd dose @ 0942 w/o issue. After she returned to work, c/o rash to chest and arms. At 1500 returned to the immunization clinic. Take to ED for evaluation BP 224/108, 88, 18, 97% O2sat. Narrative: Vaccinated with 2nd dose @0942 w/o issue. 5 hours later at 1500 returned to the immunization clinic with c/o rash to chest and arms and c/o slight H/A. BP elevated. Taken to ED for evaluation BP 224/108, 88, 18, 97% O2sat.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Blood pressure increased', 'Headache', 'Rash']",2,PFIZER\BIONTECH,IM 1023097,,32.0,F,"localized itching, erythema, & edema day 1-3, resoved on 1/5/2021, erythema & edema returned on 1/6/21 Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Erythema', 'Localised oedema', 'Pruritus']",1,MODERNA,IM 1023098,,56.0,M,Headache Left Arm soreness Narrative: Patient developed arm soreness at injection site and headache following vaccine administration. Resolved as of 1/2/21.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Headache', 'Injection site pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 1023099,,55.0,F,"Headache, Diarrhea, NauseaVomiting, chills Narrative: 1/2/21 headache nausea. 1/3/21 vomiting diarrhea chills, called in sick by 1/4 symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/02/2021,9.0,OTH,,,,,,"['Chills', 'Diarrhoea', 'Headache', 'Impaired work ability', 'Nausea', 'Vomiting']",1,MODERNA,IM 1023100,,47.0,F,Headache & NauseaVomiting Narrative: Developed headache and nausea following administration of covid vaccine. Resolved by 1/3/21.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Headache', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 1023103,,,M,"Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Muscle cramps and allodynia Narrative: Woke today joint pain, HA, 100.5 vomiting. Body ache, HA, Zofran. Able to drink a bit. Bad leg cramps last night extended to whole body. Knees and hips particularly bad. Ibu and Tylenol First dose no problems. Allodynia.- dog licking her leg feels like razor blades",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,,,,,,"['Allodynia', 'Arthralgia', 'Body temperature increased', 'Headache', 'Muscle spasms', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 1023105,,44.0,F,Fever LOW GRADE TEMP FOR 1 DAY Narrative: LOW GRADE TEMP FOR LESS THAN 24 HOURS,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/07/2021,,OTH,,,,,,['Pyrexia'],1,MODERNA,IM 1023106,,58.0,F,"Headache Chills, redness and pain at injection site Narrative: Patient reported headache, chills, redness and pain at injection site. Patient instructed to call her Primary Care Provider.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/07/2021,10.0,OTH,,,,,,"['Chills', 'Headache', 'Injection site erythema', 'Injection site pain']",1,MODERNA,IM 1025180,,72.0,F,"DIZZINESS, LIGHT SENSITIVITY, PRURITUS Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/03/2021,4.0,OTH,,,,,,"['Dizziness', 'Photophobia', 'Pruritus']",1,MODERNA,IM 1025386,,46.0,M,"Headache, Myalgia, Arthralgia, Fever, Chills Narrative: 2nd vaccine on 5th at 14:45 2245 Nausea, low-grade fever 99, bad headache like a migraine. Used ibuprofen, ""living on it"" Had headache all night extending down to shoulders. Chills x 2 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1025388,,55.0,F,Headache Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,['Headache'],UNK,PFIZER\BIONTECH,IM 1025390,,38.0,F,"Headache, Myalgia, Fever, low back pain Narrative: Spoke to Occ health only, no medical attention, has stayed out of work.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,OTH,,,,,,"['Back pain', 'Headache', 'Impaired work ability', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1025433,,34.0,F,"LYMPHADENOPATHY TO RIGHT AXILLA, 3X3CM AREA OF ERYTHEMA, INDURATION, AND WARMTH TO INJECTION SITE (RIGHT DELTOID) Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/06/2021,6.0,OTH,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site warmth', 'Lymphadenopathy']",1,MODERNA,IM 1025440,,49.0,F,Arthralgia & Rash Narrative: Rash - limited to left cheek and neck (resolved in 3 hours),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Arthralgia', 'Rash']",1,MODERNA, 1025446,,38.0,F,"ErythemaMultiform harden, redness warm to touch around injection site Narrative: 7 day post vaccine, employee noted L upper arm hard, redness and warm to touch. 2-3 pain level, more discomfort. employee has been icing.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/07/2021,7.0,OTH,,,,,,"['Erythema multiforme', 'Injection site discomfort', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 1025455,,50.0,F,"Headache, Myalgia & Fever Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/06/2021,14.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 1025462,,51.0,F,"Myalgia SOFT TISSUE SWELLING RIGHT AXILLA, SWOLLEN UPPER ARM; Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Lymphadenopathy', 'Myalgia']",2,PFIZER\BIONTECH,IM 1025468,,62.0,M,"Dizziness, Headache, Myalgia, NauseaVomiting, dehydration, could not eat, runny nose, sore throat-employee reported being off work since the day of her injection Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Dehydration', 'Dizziness', 'Feeding disorder', 'Headache', 'Impaired work ability', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Rhinorrhoea', 'Vomiting']",UNK,MODERNA, 1025572,,55.0,M,"Headache, Tachycardia, Fatigue, dizziness Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Dizziness', 'Fatigue', 'Headache', 'Tachycardia']",1,PFIZER\BIONTECH,IM 1025575,,53.0,F,"Headache, Myalgia, SkinRash, NauseaVomiting, rash localized to injection site Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,,,,,,"['Headache', 'Injection site rash', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA, 1025576,,37.0,F,"Rash, Diarrhea & NauseaVomiting Narrative: Fatigue developed 1/3/2021 along with mild nausea/abd cramping. Then on 1/6/2021 at 6:00pm noticed slightly pink area at site of injection which has gotten slightly worse and has not resolved yet. Area of redness on right deltoid measures 6.5cm x 5.0cm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/03/2021,3.0,OTH,,,,,,"['Abdominal pain', 'Diarrhoea', 'Fatigue', 'Injection site erythema', 'Nausea', 'Rash', 'Vomiting']",1,MODERNA,IM 1025577,,53.0,M,Fever & Diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,OTH,,,,,,"['Diarrhoea', 'Pyrexia']",1,MODERNA,IM 1025580,,55.0,F,"Diarrhea & NauseaVomiting Narrative: jaw pain, metallic taste, cramps",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,,,,,,"['Diarrhoea', 'Dysgeusia', 'Muscle spasms', 'Nausea', 'Pain in jaw', 'Vomiting']",1,PFIZER\BIONTECH,IM 1025584,,51.0,M,"Dizziness, Tachypnea & NauseaVomiting Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Dizziness', 'Nausea', 'Tachypnoea', 'Vomiting']",1,MODERNA,IM 1025597,,46.0,M,Headache Fatigue Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Fatigue', 'Headache']",1,PFIZER\BIONTECH,IM 1025604,,35.0,F,"Headache, Myalgia & Fever Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 1025612,,49.0,F,"Headache, Sedation, Myalgia, Chills, aches, nausea, fatigue, headache, Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/29/2020,,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Sedation']",1,MODERNA,IM 1025663,,47.0,M,Headache c/o hypertension post vaccination - bp was 165/116 - history of HTN Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,N,,01/08/2021,,OTH,,,,,,"['Condition aggravated', 'Headache', 'Hypertension']",1,MODERNA,IM 1025669,,29.0,F,"Low grade fever, fatigue, chills, sore arm. Narrative: Low grade fever, sore arm, chills, and fatigue developed after administration of covid vaccine. Resolved by 1/1/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1025670,,55.0,M,"Sweaty/Clammy, vomiting Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Cold sweat', 'Hyperhidrosis', 'Vomiting']",1,PFIZER\BIONTECH,IM 1025671,,39.0,F,Angioedema LUMP IN THROAT Narrative: WAS GIVEN AN EPI PEN AND TRANSPRTED TO A LOCAL ER WHERE SHE RECEIVED IV BENEDRYL AND STEROIDS,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,,,,"['Angioedema', 'Sensation of foreign body']",1,MODERNA,IM 1025672,,55.0,M,very mild flu-like symptoms-employee reported feeling hot for 2 days after injection Narrative:,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,OTH,,,,,,"['Feeling hot', 'Influenza like illness']",UNK,MODERNA, 1025824,,55.0,F,Myaglia left arm is painful Narrative: Employee reports onset of body aches on 12/29. She denies fever. Her left arm is also very painful. 12/31 - symptoms resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Myalgia', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 932061,VA,53.0,F,"Chills, body ache,headache, and fever (101). These symptoms started at 3:00 am on 01/09/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PUB,"Losartan Potassium 50 mg 2x daily Vitafusion multi vitamin, vitamin D-3 50,000 IU",,Sjogren's syndrome,,None,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,SYR 932062,IL,43.0,F,"12hrs after vaccine: loss of taste x 24hrs, night sweats x4nights, mild chest/throat tightness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Amlodipine 2.5mg daily, losartan 25mg daily, levothyroxine 150mcg daily, levothyroxine 25mcg Monday/Wednesday/Friday, valacyclovir 500mg Monday/Friday, vitamin d 2000iu daily, diclofenac 75mg daily",None,"Hypertension, Graves? disease, acquired hypothyroidism, herpes (chronic)",,Sulfa,"['Ageusia', 'Chest discomfort', 'Night sweats', 'Throat tightness']",1,MODERNA,IM 932063,TX,41.0,F,Vaccine was given in wrong spot and 4 days later I developed a red/blue spot about the size of a quarter that itches and feels like it has a knot below the skin.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PUB,"Synthroid, Liothyronine, Vitamin D3, Vitamin B12, Biotin, Losartan/HCTZ, Metoprolol Succinate",,Hashimoto?s Thyroiditis Hypertension,,Latex and Codeine,"['Erythema', 'Nodule', 'Product administered at inappropriate site', 'Pruritus']",1,MODERNA,SYR 932065,MT,65.0,F,"Tachycardia with first dose on Dec 17, then, with 2nd dose experienced off and on tachycardia and also irregular rhythm , no other cardiac related sequels . Second dose, 1/7/21, experienced fever on 1/8/21 of 101.6 off and on that day. Used mainly Advil and Tylenol for fever and headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,None,None,None,,None,"['Headache', 'Heart rate irregular', 'Pyrexia', 'Tachycardia']",2,PFIZER\BIONTECH,IM 932066,GA,33.0,M,Painful swollen lymph node under arm. Went away after 4-5 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/01/2021,6.0,OTH,Vitamin D,None,None,,None,"['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 932067,VA,38.0,F,I developed a rash on the same arm that received the vaccine 8 days later.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PUB,"Allegra, Gianvi (birth control pill), Spirulina",none,Seasonal allergies,Pertussis,Allergy to the pertussis component of TDAP,['Rash'],UNK,MODERNA,IM 932068,MI,54.0,F,Extreme pain in shoulder to the extent I cannot move or use my arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,PUB,Olmesartan Medoxomil 40mg Hydrochlorothiazide 25mg Levothyroxine Sodium,,,,,"['Arthralgia', 'Loss of personal independence in daily activities', 'Mobility decreased']",1,MODERNA,SYR 932069,WA,59.0,F,0945 Patient reports tingling tongue; itching on upper arms; facial flushing HR 83; SPO2 99%; BP 150/100 - patient states she did not take BP meds today 0957 Patient administered 50mg Benadryl PO 1030 Patient released; reports symptoms remained mild and felt stable enough to return home,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,,,,,,"['Flushing', 'Paraesthesia oral', 'Pruritus']",1,MODERNA,IM 932070,HI,36.0,F,"Headache, Vertigo, and nausea for one day 7am-3pm, sore arm all day for one day, I used Ibuprofen for the headache and slept off all the symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,over the counter Multivitamins,None,Asthma,,Penicillin,"['Headache', 'Nausea', 'Pain in extremity', 'Vertigo']",UNK,PFIZER\BIONTECH, 932071,TX,78.0,F,Severe pain at lower left rib cage. Transit to all upper body. Still in progress.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,SEN,"liothyronine 25 mcg tablet, estradioL 1 mg tablet, traMADoL 50 mg tablet, esomeprazole 40 mg DR capsule, amLODIPine 10 mg tablet, ezetimibe 10 mg tablet, levothyroxine 175 mcg tablet, atorvastatin 40 mg tablet, sertraline 50 mg tab",none,Bursitus,,"Naproxen Sodium, Clarithromycin, Ibuprofen, Pravastatin, Shellfish Derived Iodine/Shellfish allergy per patient","['Blood test', 'Chest X-ray', 'Musculoskeletal pain']",1,MODERNA,IM 932072,MI,49.0,F,Severe global itching and urticarial rash,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,,Psoriatic Arthritis,Psoriatic Arthritis,,,"['Pruritus', 'Urticaria']",1,MODERNA,IM 932073,VA,30.0,F,"At 8 am on Friday morning, about 14 hours after I received my 2nd dose of Pfizer covid vaccine, I had muscle soreness and aching. I went home and slept after working night shift. I woke up at 11 am, 17 hours post vaccine, and had a 102.4 F fever, chills, body aches and headache. At 3pm I still had 102-103F fever and called employee health and in which was directed to take Tylenol or Advil. I took 600mg Advil, and my fever broke at 8 pm, 26 hours post vaccine. That night my fever returned 102-103 F, I continued to take Advil. I took Advil around the clock, but let it lapse in dose Saturday evening 50 hours after receiving my vaccine. I then had a 101.5 F temp, I waited and it continued to rise, at midnight tonight, 30 mins ago, I took 600 mg Advil",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,None,None,PCOS,"I was told by my mom that I passed out after receiving the MMR vaccine age less than 1, I never received a second dose. This was",None,"['Chills', 'Headache', 'Myalgia', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932074,WA,37.0,F,"1257 Patient reports feeling lightheaded; tongue tingling; throat tingling/itching 1300 BP 130/60; HR 87; SPO2 97% 1315 Patient administered Benadryl 50mg PO 1330 BP 110/60; HR 63. Patient drowsy, states legs feel heavy, patient feels unstable 1337 EMS called; patient evaluated and declined transfer; EMS assisted patient home",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PUB,,,,,,"['Dizziness', 'Feeling abnormal', 'Limb discomfort', 'Paraesthesia oral', 'Pharyngeal paraesthesia', 'Somnolence', 'Throat irritation']",1,MODERNA,IM 932075,WA,46.0,F,"Erythema on right shoulder at injection site, red, itchy, 4 inches height x 3 inches wide, 8 days after given",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,WRK,None,None,None,,"Unknown, none yet","['Injection site erythema', 'Injection site pruritus']",1,MODERNA,SYR 932076,CA,61.0,F,"chills, fever, arm pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,zyrtec and multi vitamin once a day,none,none,,Sulfa based drugs,"['Chills', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 932077,WA,60.0,F,1300 Patient reports tingling throat and tongue 1315 Patient administered 50mg Benadryl PO 1400 Patient released; reports symptoms remain mild,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PUB,,,,,,"['Paraesthesia oral', 'Pharyngeal paraesthesia']",1,MODERNA,IM 932078,OR,48.0,F,"Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach queasiness. HR was 156, sats were 100 % on room air. Seemed to subside after 30 minutes . However throughout the rest of the day, waves of similar symptoms recurred predominantly tachycardia and GI along with skin sensitivity. Overnight did ok, but the following morning, again re urged with sustained tachycardia at which time sought ED evaluation. Had one episode in ED with HR in 151, other vital signs maintained. Received solumedrol and Benadryl. After treatment and monitoring without recurrence, discharged home on prednisone , Benadryl. Ativan if needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Levothyroxine, tamoxifen",None,"Hypothyroidism, Treated with surgery/ chemo/ radiation for breast cancer ( 2010- 2011), now no evidence of disease.",,Severe local / regional reaction to bee sting otherwise no known allergies.,"['Abdominal discomfort', 'Anxiety', 'Electrocardiogram', 'Full blood count', 'Metabolic function test', 'Nausea', 'Paraesthesia', 'Sensitive skin', 'Tachycardia']",1,PFIZER\BIONTECH,IM 932079,NC,41.0,F,"I was exposed to a covid positive person on 12/15/2020, 13 days before receiving my first dose on 12/29/2020. I started feeling unwell on 12/31/20. On 1/1/2021, chills and body aches started for two days. I continue to have daily headaches and off and on chills and body aches. Other symptoms are congestion, running nose and diarrhea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/01/2021,10.0,PUB,birth control,Slight stuffiness allergy like symptoms,,,none,"['Chills', 'Diarrhoea', 'Headache', 'Malaise', 'Pain', 'Respiratory tract congestion', 'Rhinorrhoea', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,SYR 932080,MD,27.0,F,Day 1 of injection regular arm soreness Day 5 axillary soreness and tenderness Day 8 raised and red rash on injection arm but below the injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,UNK,"75mg Sertraline, microgestin",,,,,"['Axillary pain', 'Pain in extremity', 'Rash erythematous', 'Rash papular', 'Tenderness']",1,MODERNA,IM 932081,AZ,25.0,M,"Severe pain at injection site, nsaid pain reliever, pain subsided after about 2 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,"Asthma, bronchitis",,None,['Injection site pain'],1,MODERNA,SYR 932082,OH,41.0,F,"Red, raised warm swollen area at injection site, whole body rash",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/09/2021,11.0,PVT,"Albuterol, qvar",None,Asthma,,Penicillin,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Rash']",1,MODERNA,IM 932083,OK,56.0,F,"Took shot abotut 3:37 mild headache starting appx 4 hours after, overnight arm became very sore with palpable know in area, Next day had - very sore arm with knot, some nausea, neck and shoulder stiffness, felt flushed off and on and fatigue 2nd day after (today) - arm is much better but still sore and with knot, nausea off and on today with one episode of vomiting,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Metformin Hcl Tab 500mg 1 daily, Atorvastin Tabs 10mg 1nightly, Lisinopril 2.5mg 1 daily, estradiol Tabs 5mg 1/2 tablet/day, Fluticasone Propionate 50mg/ spray 2 sprays 1x/day, Claritin 10mg",None,"diabetic, hypertension, high cholestrol, obese, arthritis",,Sulfa,"['Fatigue', 'Flushing', 'Headache', 'Musculoskeletal stiffness', 'Nausea', 'Nodule', 'Pain in extremity', 'Vomiting']",1,MODERNA,IM 932084,WA,45.0,F,"Please help. I received the moderna vaccine on Dec 30th (health care professional) today is January 9th. I have a baseball size rash, hot to touch, not painful that started last a Tuesday (six days after injection). At first my arm was a bit sore but nothing more than the flu vaccine. I have drawn a circle around the mark to see if it is increasing in size, it has been increasing each day. I went to dr and they. Told me they don?t know what is causing this but put me on an antibiotic. I am scheduled for second vaccine on Jan 25th. Not sure if I should still get this.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,UNK,None,None,Hypertension,,None,"['Pain in extremity', 'Rash', 'Skin warm']",1,MODERNA,IM 932085,MO,29.0,F,Local injection site arm pain,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PHM,,,,,,"['Injection site pain', 'Local reaction']",1,MODERNA,IM 932086,MD,58.0,F,"Elevated temperature (in late afternoon was 97.6, now, several hours later, is 99.2), feeling chilled, headache, malaise.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/10/2021,2.0,OTH,"Lamictal, albuterol inhaler","Asthma, emphysema","Asthma, emphysema, history of partial seizures, arthritis, osteoporosis , ectodermal dysplasia",,None,"['Body temperature increased', 'Chills', 'Headache', 'Malaise']",1,MODERNA,SYR 932088,CT,40.0,F,"12 hr after injection: headache myalgia, arthralgia, fever, abdominal pain, severe nausea started and lasted for 12 more hours. Conservative management at home with oral fluid hydration, acetaminophen and ibuprofen helped improved symptoms. Headache is still present on 1/10 at 0200 am, over 24 hr after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Pepcid 20 mg daily, multivitamins, zinc 25 mg daily",None,None,,Latex,"['Abdominal pain', 'Arthralgia', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932090,TX,32.0,M,"Episodes of diarrhea starting approximately 4 hours after injection, and lasting through 01/09/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,,,,,,['Diarrhoea'],1,MODERNA,IM 932091,FL,50.0,M,"Started severe belly pain and went to Emergency room and diagnosed with mesenteric vein thrombosis after the CT scan of the abdomen, treated with heparin drip, antibiotic and discharged with anticoagulant pills(Eliquis). I am not sure that it is because of the vaccine my doctors are also not sure about it, but I am sure that I am a healthy person without any health issues . I am working as registered nurse, our unit is for covid-19 patient's since march 2020 and I had covid -19 on August month and recovered after 3 weeks.",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,12/16/2020,01/05/2021,20.0,WRK,NO,NO,None,,Simvastatin,"['Abdominal pain', 'Computerised tomogram abdomen abnormal', 'Mesenteric vein thrombosis']",1,PFIZER\BIONTECH,IM 932092,TN,38.0,M,"Patient works late evening shift, worked until 2am, went home, came back to hospital for vaccine at 6am. Received vax and went home, slept 7 hours, got up and had an extremely strenuous workout including deadlifts (pyramid to heavy weight, 275lb x 5 reps in HIIT sets with kettlebell swings, and boxing in garage gym. Was 45 dF at the time. Patient was finishing workout with last 2 minutes boxing on a 100lb heavy bag and suddenly felt violent ""pop"" in right medial gastrocnemius muscle. Pt stopped workout and could barely put weight on right leg and reported back to work for shift within 45 minutes of event. Pt iced 4x per day for next 2 days (current), walking better by 2nd day but still very painful and unable to put much weight on forefoot. This has never occurred to patient. Possibly related to vaccine? Worth reporting",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,sertraline,none,none,,nka,"['Myalgia', 'Somnolence', 'Weight bearing difficulty']",1,PFIZER\BIONTECH,IM 932093,CA,53.0,F,"6 cm Rash and swelling on left deltoid, chills occurred on 8th day after vaccination. chills resolved but still have rash on arm. had left eye pain occur on 9th day after vaccination that lasted for 1 day. also had left arm soreness that started 3 hours after vaccination and lasted 2 days. cold sore developed 2 days after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,Plaquenil Oral contraceptive pill Neurontin Aciphex Ambien,None,Lupus Asthma Seasonal allergies Peripheral neuropathies Low back pain,sore arm after every influenza vaccine that lasts for a few days,Clarithromycin,"['Chills', 'Eye pain', 'Injection site rash', 'Injection site swelling', 'Ophthalmological examination normal', 'Oral herpes', 'Pain in extremity', 'Rash']",1,MODERNA,IM 932094,FL,69.0,M,"Hives, extreme itching body wide",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/09/2021,4.0,PVT,"Prilosec, Ezetimebe",None,None,,Penicillin,"['Chest X-ray', 'Full blood count', 'Metabolic function test', 'Pruritus', 'Troponin', 'Urticaria']",2,PFIZER\BIONTECH,IM 932095,WA,56.0,F,1.) immediate pain in injection site that lasted until the next day. Pain relieved after taking Tylenol the morning after 2.) elevated skin temperature at night documented as 3 degrees above baseline by Fitbit Sense 3.) headache felt 26 hours after vaccine administration; 101.7 degree temperature documented 26 hours after vaccine administration since Tylenol 500 mg taken in the morning 4.) symptoms resolved the next day,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,SCH,"amlodipine, fish oil, vitamin c, vitamin d, centrum silver women, Move Free (glucosamine-chondroitin)",none,hypertension,,none,"['Body temperature increased', 'Headache', 'Immediate post-injection reaction', 'Injection site pain', 'Skin warm']",1,PFIZER\BIONTECH,IM 932096,CA,43.0,F,I got the vaccine at 3:50. I got a sore arm within about 3 hours. I woke up I at 1am with a sore throat,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/10/2021,9.0,PUB,"Zoloft, colonizing, microgestin",None,None,Sore arm with annual flu shot,"Sesame, papaya","['Oropharyngeal pain', 'Pain in extremity']",1,MODERNA,SYR 932097,,22.0,F,Rash to left pectoral area that does not extend further down than breast. Rash is not itchy or painful. Redness has subsided slightly within 24 hours of the vaccine but remains there after 48 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,WRK,ASHLYNA BIRTH CONTROL MULTIVITAMIN WITH IRON,,,,SULFA,"['Erythema', 'Rash']",2,PFIZER\BIONTECH,IM 932098,IN,39.0,F,Fever 101.4 Arm sore,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/10/2021,1.0,PVT,Indapamide 2.5mg qd Spironolactone 50mg bid,None,Kidney stones,,Amoxicillin,"['Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932099,CA,49.0,F,"Left deltoid soreness, radiated to left neck and ear area, followed my immobility of left upper arm, sever painful joint aches, especially to weight bearing joints and long bones, mild facial swelling, mild SOB, headache, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Vit D3, Estrovan hormone supplements , Zoloft 100 mg daily MVI",None,None,,None,"['Arthralgia', 'Dizziness', 'Dyspnoea', 'Ear pain', 'Headache', 'Injected limb mobility decreased', 'Injection site pain', 'Neck pain', 'Pain', 'Swelling face']",1,MODERNA,SYR 932100,VA,45.0,F,Raised nodules and redness at site of injection extending to surrounding areas up to the middle of the arm 1 week after vaccination. Itching also present.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,,None,None,,Sulfonamides,"['Injection site erythema', 'Injection site nodule', 'Injection site swelling', 'Pruritus']",UNK,MODERNA, 932101,MI,36.0,F,"throat swelling immediately following injection; received epi. next morning woke up with cough, fatigue, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,UNK,"Vitamin D, Sambucol, ibuprofen",none,none,,Amoxicillin,"['Cough', 'Fatigue', 'Myalgia', 'Pharyngeal swelling']",UNK,MODERNA,IM 932102,TX,27.0,M,"104.0� fever, shaking. Started approximately 12 hours after second dose. Lasted for 6 hours then went away. Following night, fever of 101.9� and slight shaking. Chest pain. Oxygen saturation still at 97%",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,UNK,None,None,,,Lactose intolerant,"['Chest pain', 'Pyrexia', 'Tremor']",2,PFIZER\BIONTECH,SYR 932103,IL,53.0,F,"Swelling, redness and itching of injection site roughly 5?x 4? welting.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/08/2021,10.0,PVT,Woman?s Multi vitamins for over 50+ only.,None,None,,Non,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Urticaria']",1,MODERNA,IM 932104,,54.0,F,"Day. 6: fever, headache , intense body aches more on the right side. Vomited once but tensioned nauseous. Day 7: symptoms worsened . I had a fever throughout the night but fever broke my morning Day 8 post vaccine, feeling much better, no fever. I recognize these symptoms aren?t life threatening and I could have been exposed to covid after the vaccine, I don?t know. I?m just trying to help get the data out there for the pharmaceutical companies and the public to have",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/06/2021,6.0,PVT,Bruporion XL Baby aspirin Trazadone Dioxepin,Hyperprolactemia X-ray recently showed plueral thickening and scarring in one lung,Severe back problem Asthma,,Compazine - seen more as a sensitivity than a true allergy,"['Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test', 'Vomiting']",1,PFIZER\BIONTECH,IM 932105,FL,71.0,F,"1pain in right[opposite] shoulder and arm lasted 12 hours then 2 scalp localized tenderness over 24 hours affected ear pinna then jaw then neck . neck pain persists til today. exam by doctor revealed a red spot oil scalp behind ear,, size of quarter] no evidence trauma or insect bite, no lymphadenopathy. as of now minor pain , no edema no erythema. pain was so sever it prevented sleep.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,WRK,"prozac, atorvastatin, omeprazole, cozier, pramipexole",none,"hypertension, hyperlipidemia, skin cancers, depression, restless leg syndrome,",,latex,"['Arthralgia', 'Ear pain', 'Neck pain', 'Pain in extremity', 'Pain in jaw', 'Pain of skin', 'Tenderness']",1,MODERNA,IM 932107,NY,37.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Miscarriage - (date of vaccination 1/6/21, miscarriage symptoms (cramping) started 1/8/21, confirmed 1/10/21; estimated date of delivery 8/30/21)",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/08/2021,2.0,PVT,"Fluticasone, azelastine, prenatal vitamin",None,None,,None,"['Abortion spontaneous', 'Exposure during pregnancy', 'Muscle spasms']",UNK,PFIZER\BIONTECH, 932108,FL,33.0,F,"30 min acter swollen throat, extreme dizziness and sudden rise in temperature. Took 25mg benadryl 1 hour after, those symptoms went away slowly For 24 hours after extreme body aches, chills, no fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/28/2020,0.0,PUB,Adderall 20mg xl,None,Adhd,,None,"['Chills', 'Dizziness', 'Pain', 'Pharyngeal swelling', 'Pyrexia']",1,MODERNA,IM 932109,CT,36.0,F,"Severe generalized headache, pressure/squeezing in nature with nausea and extreme fatigue x 28 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Atenolol, Esomeprazole, Prenatal vitamin, Zoloft",Covid-19 diagnosed 12/1/20,Tachycardia,,Nonr,"['Fatigue', 'Headache', 'Nausea']",1,MODERNA,IM 932111,,46.0,F,"Red, raised, blotched, itchy around injection area x 4 days. Also, very sore arm on day 2-4.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/07/2021,4.0,MIL,"Gabapentin 600 mg, Zyrtec 10 mg, Lexapro 20mg, VIT B12, VIT C, VIT D, Multi VIT",,"Asthma, Linden Factor V, Depression, Anxiety",,"PCN, CIPRO, Demerol, dust mites","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Pain in extremity', 'Rash macular']",1,MODERNA,IM 932112,NJ,26.0,F,"Headache and fatigue 2-3 post injection, arm soreness approximately 8 hours post injection. Poor sleep night of injection, woke up at 0630 with significant muscle aching, allodynia, and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,"Sertraline, mili OCP, doxycycline, acetaminophen, diphenhydramine, phentermine",Current non-healing traumatic wound to hand,"IBS, depression, anxiety",,"Tramadol, dairy, corn products","['Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Pain in extremity', 'Poor quality sleep']",2,PFIZER\BIONTECH,IM 932113,OH,37.0,F,throbbing pain radiating from shoulder blade down arm into pinky for hours,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,WRK,Aleve Tylenol,,,,"solodyn,lopressor","['Arthralgia', 'Pain', 'Pain in extremity']",1,MODERNA,IM 932115,VA,39.0,F,Swollen and sore lymph node on side of injection. Anxiety with chest tightness and shortness of breath,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/01/2021,6.0,PVT,"Folate, Vitamin B complex, Vitamin E, Vitamin C",,,,Red dye 40,"['Anxiety', 'Chest discomfort', 'Dyspnoea', 'Injection site lymphadenopathy', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 932116,IN,45.0,F,Pain under arm . Started as soreness per usual . Now I have a lump in my arm pit . Very sore . Painful when I try to massage it . I had not heard of this effect so thought I would report it . I will contact my Doctor if it hasn?t subsided in 7 days .,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Excedrin , Effexor , maxalt",,Migraine,,,"['Axillary mass', 'Axillary pain']",2,MODERNA,SYR 932117,SC,51.0,F,"Lymph nodes along left neck swollen, soreness bilateral arm pits, and soreness at symphysis pubis area. General headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,PVT,"Vit D3, Vit B12, metformin, Ramipril ,folate, and aldactone",none,HTN and DM2,,no allergies,"['Axillary pain', 'Headache', 'Lymphadenopathy', 'Pelvic discomfort']",2,PFIZER\BIONTECH,IM 932118,OH,52.0,F,"SPINE HURT, SORE THROAT, VERY TIRED off and on still 6:45 PM WED face went numb had hard time with my words, arms and legs very heavy, almost felt like having a pancreatic attack with out the throwing up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,WRK,"Valtrex, vit b, vit d, multi vit, enzymes, therazinc elderberry lozenges",none,"pancreatic attacks food induced, 2 last year or if I drink strong alcohol, genital herpes",Shingles shot the 2nd shot made me feel like i had shingles,"PCN, latex","['Aphasia', 'Fatigue', 'Hypoaesthesia', 'Limb discomfort', 'Oropharyngeal pain', 'Spinal pain']",UNK,MODERNA, 932120,OH,58.0,F,"Tuesday 1/5/21 at 12:30p.m. I recieved the Moderna Covid 19 vaccine EUA in my left arm. I had no reaction at all untill about 3:00a.m. on 1/6/21. I woke up with the chills and a headache. At 8:00a.m. I also experienced in addition to those symptoms, fatique, body aches and diarreha. I also lost my appetite completely. When I had covid in October, I experienced thses very same symptoms. These lasted all day untill around 7:00p.m. and I felt good almost all at once the symptoms seemed to be gone. The next day I was a little fatigued still and still no appetite. Everything became normal on friday 1/8/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,lexothyroxine and simvistatin,none,hypothyroid and cholesterol,,general seasonal allergies,"['COVID-19', 'Chills', 'Decreased appetite', 'Diarrhoea', 'Fatigue', 'Headache', 'Pain']",UNK,MODERNA,IM 932121,WI,63.0,F,Waking up at 02:00 on 01/08/21 with chills. all 4 extremities where shaking I was that cold.. temp of 100.4. weak. stayed home from work. then on 01/09/21 I spent all day in bed as well. very tired. my arm was VERY painfull when touched or would try to use it.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,SEN,multi vitamin,None,None,"Shingles vaccine. 07/2020,",None,"['Body temperature increased', 'Chills', 'Fatigue', 'Feeling cold', 'Impaired work ability', 'Pain', 'Pain of skin', 'Tremor']",1,MODERNA,SYR 932122,RI,32.0,F,Tenderness in arm 9 days post injection followed by heat and erythema at injection site not previously there currently increasing in size.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/09/2021,9.0,WRK,Citalopram,None,None,,NKA,"['Injection site erythema', 'Injection site warmth', 'Tenderness']",1,MODERNA,IM 932123,MA,67.0,F,"Slightly raised, slightly red itchy area about the size of a quarter",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,PVT,"pravastatin, losartan, levothyroxine, buproprion, cholecalciferol, ferrous sulfate, melatonin",,"hypothyroidism, hypertension, hypercholesterolemia, depression, bilateral hearing loss",,,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA,IM 932124,CA,44.0,F,"Left axillary lymphadenopathy at 5-8 days Nausea, Stomach pain, and diarrhea at 7 days post vaccine, lingering mild abdominal discomfort at 8-10+ days. No sick contacts or unusual foods. Tested negative for COVID on weekly testing.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,PVT,,,"hashimoto thyroiditis, asthma",,"sulfa / bactrim, adhesive, elastic","['Abdominal discomfort', 'Abdominal pain upper', 'Diarrhoea', 'Lymphadenopathy', 'Nausea', 'SARS-CoV-2 test negative']",UNK,MODERNA,IM 932125,FL,62.0,F,"Severe headache, nausea and torso rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,UNK,None,None,None,,None,"['Headache', 'Nausea', 'Rash']",1,MODERNA,IM 932126,FL,58.0,F,"8 days after vaccine received left deltoid became red, swollen, warm to touch itchy and irritated. I took Benadryl 25mg prior to sleep. The next morning the site was still warm and irritated, swelling improved slightly. By evening swelling and discomfort was gone. The area stayed slightly reddened for a total of 4 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,OTH,none,none,none,,penicillin,"['Injection site discomfort', 'Injection site erythema', 'Injection site irritation', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 932127,MA,32.0,F,"Headache, chills, body aches and night sweats.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,HUM nutrition vitamins Birth control (Sronyx 0.02mg tablet) Allergy meds (Cetirizine 10mg tablet and Famotidine 20 mg tablet twice daily),Tested positive for Covid-19 on 12/23/2020,,,,"['Chills', 'Headache', 'Night sweats', 'Pain']",1,MODERNA,IM 932128,IL,51.0,F,"No temperature, itching and rash at injection site on right upper arm",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/10/2021,3.0,OTH,,,,,,"['Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 932129,NY,40.0,M,Fever Chills Weak Fatigue Stomach issues,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,OTH,Vitamin d Vitamin b12 Testosterone Anastrozole Multi vitamin Vitamin c Amlodipine,None,None,,Amoxicillin Levaquin,"['Abdominal discomfort', 'Asthenia', 'Chills', 'Fatigue', 'Pyrexia']",1,MODERNA,IM 932130,FL,66.0,F,I WENT TO CONVENTION CENTER UNDER HEALTH DEPARTMENT . I WAS GIVEN AN INJECTION INTO MY RIGHT ARM. SHE BUNCHED THE SKIN. I NOTED FLUID DRIPPING DOWN MY ARM AT THE END OF THE INJECTION. I ASKED IF I GOT THE DOSE. SHE SAID YES. SHE THEN SAID AND YOU GET A FREE MASSAGE AND BEGAN TO MASSAGE IT IN. WHEN FINISHED I LEFT AND NOTED A BULGE IN THE AREA WHERE THE SHOT WAS GIVEN. I BELIEVE THE INJECTION WAS GIVEN SUBCUTANEOUSLY AND NOT INTRAMUSCULAR.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,OTH,HYDROCHLORATHIAZIDE SYNTHROID CALCIUM CITRATE,NO,NO,,NO,"['Exposure via skin contact', 'Incorrect route of product administration', 'Injection site extravasation', 'Injection site swelling']",1,MODERNA,SC 932131,NY,32.0,F,"1 week after first dose, red rash /skin irritation appeared over injection site and across lateral shoulder. Swollen, red and warm to touch, mildly itchy. Rash is approximately 2 inches by 4 inches. Rash still present the following day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/09/2021,7.0,PVT,Prenatal vitamins and prenatal DHA,none,Celiac disease,,Celiac disease (gluten),"['Injection site irritation', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 932132,NY,37.0,F,Hypotensive shock after 12 hrs of administration.. with frequent vasovagal episodes,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Melatonin,None,Restless leg syndrome,,None,"['Hypovolaemic shock', 'SARS-CoV-2 test negative', 'Syncope']",2,PFIZER\BIONTECH,IM 932133,NY,66.0,M,"Chills, fever, pain in shoulders, soreness in legs, unable to sleep",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,WRK,"Valsartan 160 mg Tansulosin 0.4 capsule Fish oil, vitamin D supplement, multi-vitamin",None,High blood pressure Enlarged prostate,,None,"['Arthralgia', 'Chills', 'Insomnia', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 932134,IN,21.0,F,"At around 11 pm, I started to feel nauseous. I had had a sore arm all day which I expected, but after trying to sleep it off I woke up around 2am shivering and sweating through my shirt at the same time, and had a 98.7 temperature (normally I am 97.2 so that's high for me). My arm started to have some swelling at the site, but I woke up this morning and the fever, chills, and nausea are still very much present about 24 hours after receiving the first dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PHM,"Wellbutrin, Zyrtec, Buspar, Levothyroxine, Gianvi",Covid 19 the first week of December,Hypothyroidism,,Penicillin,"['Chills', 'Hyperhidrosis', 'Injection site swelling', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Sleep disorder']",UNK,MODERNA, 932135,KS,41.0,F,"Wheezy, chest tightness, SOB within 45 minutes of vaccination. Took antihistamines daily x3 days after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,unknown,unknown,unknown,,"PCN (hives), Erythromycin (chest pain), hydrocodone (hives), birth control (hives)","['Chest discomfort', 'Dyspnoea', 'Wheezing']",1,PFIZER\BIONTECH,IM 932136,NC,26.0,M,"Within 4 hours of vaccination, I started experiencing loss of taste and smell. 6 hours after vaccination, there was total loss of taste and smell with associated congestion, cough and fatigue. 3 days after vaccination, my cough has gotten worse, with associated sore throat and still no taste or smell.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,MIL,-Men?s 1 A day Multivitamin HCTZ 12.5mg daily,Tested positive for Covid 19 December 2nd 2020.,Stage 1 hypertension,,NKA,"['Ageusia', 'Anosmia', 'Cough', 'Fatigue', 'Oropharyngeal pain', 'Respiratory tract congestion']",1,PFIZER\BIONTECH,IM 932137,PA,40.0,F,"11/07/2021-11/09/2021 Severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain and kidney pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/07/2021,9.0,PVT,None,None,None,,None,"['Arthralgia', 'Dizziness', 'Fatigue', 'Headache', 'Hypersomnia', 'Hypoaesthesia', 'Neck pain', 'Oropharyngeal pain', 'Renal pain', 'SARS-CoV-2 test', 'Streptococcus test']",1,PFIZER\BIONTECH,IM 932138,KS,40.0,F,"Patient received Pfizer-BioNTech COVID19 Vaccine on 01/08/2021 at 1426. Given the patient's medical history, the patient was required to stay for observation for 30 minutes. Within the first 15 minutes, the patient began to experiencing itching. Initially, there was concern that she was reacting to the bandaid (history of latex allergy). The bandaid was removed and staff confirmed the bandaid was LATEX FREE. Per protocol, the patient was administered diphenhydramine 25 mg po x 1 dose. After 15 minutes, the patient's itching continued and she started to develop a skin rash on her chest. Diphenhydramine 25 mg po x 1 dose was repeated and the decision was made to take the patient to the Emergency Department in a wheelchair. Documentation from the Emergency Department Provider: 40 y/o F who comes in from the covid vaccine clinic for a possible allergic reaction. Initially thought to be to latex but then we found out she was not given a bandaid with latex so we assume it is the vaccine. pt had a rash and scratchy throat and initialy felt improved with the benadryl, pepcid and steroids but after about 2 hours had recurrence of her sx. She was then given IM epi. She has now been observed for four more hours and is still feeling well. Will d/c to home with steroids and an epi pen and epi traning. Given return precautions and f/uw ith PCP. .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Wellbutrin, lamotrigine, naproxen, phentermine, propranolol",Unknown,"High blood pressure, irregular heart beat, obesity",,"Latex, penicillin, clindamycin, bactrim","['Pruritus', 'Rash']",2,PFIZER\BIONTECH,IM 932139,KS,58.0,F,"Pt experienced confusion, disorientation, dizziness, lightheadedness, weakness, & stiff neck following vaccination. Patient was sent home from work and symptoms persisted after rest.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,unknown,unknown,unknown,,"Tetracycline (mouth ulcers), Keflex (confusion), Opioids (nausea/migraine), clobetasol (rash/hives)","['Asthenia', 'Confusional state', 'Disorientation', 'Dizziness', 'Impaired work ability', 'Musculoskeletal stiffness']",1,PFIZER\BIONTECH,IM 932140,FL,70.0,M,"Thirty six hours post infection, fatigue, muscle aches, and fevers Lasting almost 96 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Simvastatin 40mg, ASA 81 mg,multivitamin, vitamins, vitamin D, B complex, CoQ 10,krill oil",None,None,,PCN,"['Fatigue', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 932141,NY,46.0,F,"Symptoms started 2 days after vaccine administration. Started on the right arm (opposite of injection), radiates to the right neck and fingertips. Neuropathic, worse at night. Improves to a 3/10 with ibuprofen. No weakness/sensory loss.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/09/2021,2.0,UNK,Vitamins,No,No,,No,"['Neck pain', 'Neuralgia', 'Pain in extremity']",2,PFIZER\BIONTECH, 932142,NY,55.0,M,Pt has insomnia since day of vaccination and yesterday tongue started to swell up,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/03/2021,1.0,PVT,,,,,,"['Insomnia', 'Swollen tongue']",UNK,MODERNA, 932143,NY,29.0,F,"I got palpitations and tongue numbness 5-7 mins after receiving the IM injection. No rash/wheezing/hypotension/angioedema. Got treated like anaphylaxis with epinephrine, decadron, benadryl, pepcid",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,mylan,none,none,,"citrus, cinnamon","['Blood gonadotrophin', 'Electrocardiogram', 'Full blood count', 'Hypoaesthesia oral', 'Metabolic function test', 'Palpitations']",1,PFIZER\BIONTECH,IM 932144,IL,29.0,F,Around 4 am. Fever of 100.2 and chills that lasted about 12 hours. Headache that was unrelieved by medication that lasted 24 hours. Fatigue that lasted 24 hours. Severe injection site pain that lasted 12 hours. Nausea that lasted about 12 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Singular, sprintec, atorvistatin, xyzal",None,"High cholesterol, asthma",,"Bactrum, Ceclor","['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932145,NC,96.0,F,"Patient came into the emergency department on 1/8/21 with an acute ischemic stroke with complete occlusion of her left MCA. She had acute and complete flaccid paresis of her right face, arm, and leg, complete aphasia, and neglect of the right side of her body. NIHSS of 27. Onset of deficit was between 6:30pm-7:10pm. She recieved her 1st COVID-19 vaccine dose that morning at 10:31am.",Not Reported,,Yes,Yes,,Yes,U,01/08/2021,01/08/2021,0.0,PVT,,"Hypertension, hypothyroidism","Hypertension, hypothyroidism",,None,"['Angiogram cerebral', 'Aphasia', 'Arteriogram carotid', 'Cerebral artery occlusion', 'Computerised tomogram head', 'Facial paresis', 'Hypotonia', 'Ischaemic stroke', 'Monoparesis', 'NIH stroke scale abnormal']",1,PFIZER\BIONTECH,IM 932146,NJ,62.0,F,"Fever 100.4 at 0100 am Chills, Body aches Took Motrin two hours later still chills and body aches Took Tylenol. Two hours later , fever gone and chills stopped, body aches a little. Not much!!",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/10/2021,9.0,PVT,Tylenol Motrin Lisinopril Levothyroxine,High BP Hypothyroidism,Hypothyroidism High Bp Both controlled with meds,,None,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932161,IL,34.0,F,20 hours after injection: Injection site soreness Fever Night sweats Back pain Fatigue Migraine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,,,Migraines,,"Keflex, walnuts","['Back pain', 'Fatigue', 'Injection site pain', 'Migraine', 'Night sweats', 'Pyrexia']",UNK,PFIZER\BIONTECH, 932162,IN,26.0,F,Sore arm: 12 hours post-vaccine and continues through 48 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,,,,,,['Pain in extremity'],1,MODERNA,SYR 932163,IN,25.0,F,"By 8pm on the night of my vaccine, I experienced chills & body aches. Similar to symptoms before experiencing the flu. Was tired. The next morning those symptoms went away and I had a headache for the remainder of the day on 1/9/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,Birth Control Pills,None,None,,Duricef,"['Chills', 'Fatigue', 'Headache', 'Influenza like illness', 'Pain']",2,PFIZER\BIONTECH,SYR 932165,IN,38.0,F,"Headache, body aches, arm soreness, nausea, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,UNK,None,None,None,,None,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 932166,CA,48.0,F,"Felt flush, lips tingling, ink taste in mouth, rapid heartbeat, high blood pressure.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,"Metformin, januvia, trulicity and womens one a day multi vitamin.",Corona virus in December.,Diabetes,,None,"['Dysgeusia', 'Flushing', 'Heart rate increased', 'Hypertension', 'Paraesthesia oral']",1,MODERNA,SYR 932167,FL,51.0,F,Vomiting for 12 hrs with horrible stomach pains and body aches started at 2 pm on Friday until 1 am Saturday. Stomach pains still Sunday and nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/08/2021,3.0,PVT,"Omeprazole, hctz, lopressor,",None,"High bp, depression",,Penicillin lisinopril and prednisone,"['Abdominal pain upper', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,IM 932168,TN,76.0,F,Rash,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/04/2021,2.0,PUB,"Atenolol, Omeprazole",none,"Ulcerative colitis, hypertension, reflux, osteoporosis","pneumonia vaccine many years ago, mild arm swelling, no other information","Reaction to pneumonia vaccine many years ago, arm swelling",['Rash'],1,MODERNA,IM 932169,IN,38.0,M,"Around 8pm, legs achy, back sore, chills and low grade fever around 100.5 around 1130pm, severe body aches, malaise. Chills dissipated around 7am but body aches lingered along with fatigue for the rest of the day. Slight chills the night of 1/9. Feels better on 1/10. No body aches and no chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,"Daily MV, airborne, fish oil, vit E, probiotics, alpha gpc, biotin.",None,None,Sore arm with the first CoVid vaccine,None,"['Back pain', 'Chills', 'Fatigue', 'Malaise', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932171,NY,25.0,F,"Developed swelling, redness, pain, and itching at the injection site. Symptoms started 8 days after vaccine was administered. Area of redness and swelling increased over the period of 1-2 days and was fully resolved by day 5.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/01/2021,8.0,PVT,Ethinyl estradiol/norgestimate Loratadine Ibuprofen,None,None,,None,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 932172,WI,26.0,F,"Patient received vaccine at 7:31 am. At 7:37 am patient reported burning at injection site/right arm. Minutes later started complaining of burning in her throat. Bloor pressure 138/80 Pulse 142 Oxygen 100 Temperature 98.2. Lungs sounded clear. No wheezes. At 7:47, patient reports tightness in throat has subsided but feels swollen, tightness in chest. Is still able to drink water. Blood pressure 140/90 HR 120 Oxygen 100. Called 911. Patient had many questions about receiving Epi Pen. Denies heart conditions, reports has a history increased heart rate. At 7:49 am Epi pen given left lateral thigh. BP 142/78.100% Oxygen, Pulse 129. EMS arrived few minutes after. Blood noted on left lateral thigh at Epi injection site. 2x2 applied with pressure. Report off to EMS.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/10/2021,0.0,WRK,Not assessed,not assessed,Not assessed.,,No known drug allergies and/or medication and/or foods,"['Chest discomfort', 'Heart rate increased', 'Injection site pain', 'Pain in extremity', 'Pharyngeal swelling', 'Throat irritation', 'Throat tightness']",1,PFIZER\BIONTECH,IM 932173,IN,30.0,M,"Fever, chills, headache, body aches. All improved with OTC Tylenol and Ibuprofen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,None,None,None,,None,"['Chills', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 932174,IN,33.0,F,My armpit started becoming sore the following day and now my lymph nodes are swollen and it hurts to have my arm down as it is hitting the swollen lymph nodes. I had zero issues with the first shot in the series.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,WRK,Only ibuprofen and excedrin as needed for normal body aches and migraines,None,"Hypothyroidism, anxiety/depression",,Minocycline,"['Axillary pain', 'Lymph node pain', 'Lymphadenopathy']",2,PFIZER\BIONTECH,SYR 932175,IN,41.0,F,"Chills, headache, body aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Birth control, daily vitamin, fish oil, apple cider vinegar gummies, Calcium, zyrtec",,,,N/a,"['Chills', 'Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 932176,MD,43.0,F,"About a day after the shot, I got a red circle a little bigger than a quarter around the injection site and the area was very itchy. This lasted several days. I have to assume it was an allergic reaction. Since then it has gone away however I am not sure if I should get the 2nd shot. The vaccine was Pfizer.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,SEN,"Zoloft, multivitamin, Vit C, Vit D, Fish Oil, and zyrtec",,,,,"['Injection site erythema', 'Injection site pruritus']",UNK,PFIZER\BIONTECH, 932178,CT,38.0,F,commonplace erythema around the injection site BUT THIS HAS PROGRESSED TO A FIGURATE ERYTHEMA OF THE ERYTHEMA ANNULARE CENTRIFUGUM TYPE Can I upoload a photo to you??,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,UNK,none,none,none,,none,"['Erythema annulare', 'Injection site reaction']",UNK,MODERNA, 932179,IN,32.0,F,"chills, entire right arm sore, swollen/painful lymph nodes in right axillary, fatigue, stuffy nose",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,"Zyrtec, Benadryl, multivitamin, ibuprofen",Uti,Allergies,,"Prednisone, lyrica, dilaudid","['Axillary pain', 'Chills', 'Fatigue', 'Lymphadenopathy', 'Nasal congestion', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 932180,ME,37.0,F,"sudden onset of full body burning and flushing sensation, no redness or rash objectively. This resolved over a few minutes but recurred once. She was anxious and was given a benedryl, no further symptoms. Observed for extra time then released",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,insulin,None,DM1,,None,"['Anxiety', 'Burning sensation', 'Flushing']",1,MODERNA,IM 932181,IN,36.0,F,"Pain at site of injection, extreme headache, extreme body pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,"Nuvaring, multivitamin, vitamin B12, vitamin d Tylenol, Aleve",,Fibromyalgia,,No,"['Headache', 'Injection site pain', 'Pain']",UNK,PFIZER\BIONTECH,IM 932182,IL,56.0,F,"Very fatigues, headache, nausea, intermittent chills, vomited once.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 932184,VA,57.0,F,"Fever, chills, severe body joint aches, headache started 10am day of injection lasting until 1/10/21. Improvements started 01/09/21 late afternoon. Some aches remain on 1/10/21 but minimal in comparison",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"Synthroid 200mcg po as, Wellbutrin 150 mg po bid, vit C 3000 mg po as, zinc 109 mg po Qd. Vit D3 3000 mg po qd. Biotin 5000 mcg po qd , glucosamine hack and chondroitin sulfate with NSM and hyaluronic acid. 2 po qd",None,"Hypothyroid, arthritis",,"Demerol, scopolamine","['Arthralgia', 'Chills', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 932185,GA,37.0,F,"The injection site alone with the upper arm is red, hot, and warm to touch. I marked the original spot on Friday and it has since went pass that point. It does hurt pretty bad but I have not been babying it but using it as normal. More achy than pain I would say.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,PVT,HCTZ 12.5capsule PO daily Vitamin C 500mg Mirena 20mcg Cardizem CD 180mg PO daily Echinecae 400mg Zinc,,High Blood Pressure Iron Deficiency Anemia Tachycardia; loop recorder placed,,Toradol and betadine,"['Injection site erythema', 'Injection site pain', 'Injection site warmth']",1,MODERNA,SYR 932186,MD,47.0,F,Itchy rash at site of injection. The rash is red and about an inch in diameter. Swollen.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/08/2021,9.0,PUB,Levetiracetam 500 mg tablets Hydrochlorothiazide 25 mg tablets Advair 250/50 Albuterol Sulfate inhalation Aerosol,,Asthma Anemia Seizure,,Shellfish Eggplant Calamine lotion,"['Injection site reaction', 'Injection site swelling', 'Rash erythematous', 'Rash pruritic']",UNK,MODERNA,SYR 932187,NJ,46.0,F,Shingles,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,01/05/2021,15.0,OTH,Nexium Claritin Vitamin C Multivitamin Probiotic,None,GERD Seasonal allergies Asthma,,None,['Herpes zoster'],2,PFIZER\BIONTECH,IM 932189,TX,37.0,F,"I was injected high on my shoulder, significantly higher than I?ve ever been injected in my life. I believe I have SIRVA. The pain has become so severe that I cannot use my left arm. The pain is intolerable. I take four Advil every six hours, ice my arm regularly, and keep my arm in a sling. The pain has gotten significantly worse with time (not better). I?ve never experienced pain like this from a vaccine in my life. No history of bursitis or shoulder injury. Again, the pain gets worse with time. I?m almost 48 hours post injection",Not Reported,,Not Reported,Not Reported,,Yes,N,01/08/2021,01/09/2021,1.0,PUB,None,None,None,,None,"['Injected limb mobility decreased', 'Pain in extremity', 'Product administered at inappropriate site', 'Shoulder injury related to vaccine administration']",UNK,MODERNA,SYR 932194,IN,46.0,F,"Arm soreness, myalgia, fever, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,,,,,,"['Fatigue', 'Myalgia', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932195,IN,48.0,F,"Low grade fever and body aches for 24 hours, then headache and swollen lymph node under armpit on side of injection. Swollen and sore injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Prozac, seasonique, vitamins",,,,,"['Headache', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy', 'Pain', 'Pyrexia']",1,MODERNA,SYR 932197,IL,66.0,F,Headache and flu like symptoms lasting 20 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Crestor, vitamin d",None,None,,Nonenone,"['Headache', 'Influenza like illness']",2,PFIZER\BIONTECH,IM 932198,NJ,39.0,F,"Rash from neck to hip bones, fever, flu like symptoms, severe pain to injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PUB,"Centrum, Vitamin D3, Vitamin B12",None,None,,NKA,"['Influenza like illness', 'Injection site pain', 'Pyrexia', 'Rash']",1,MODERNA,IM 932199,MI,53.0,F,"I had the first shot on Thursday evening, I felt fine throughout the evening. Friday woke up with a headache and sore arm. Friday afternoon my headache worsened, I had a tempature between 101 and 103 and severe chills. I was nauseous and fatigue. This continued through Saturday. Tempature and chills went way by Saturday evening. Sunday most all symptoms are gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Ambien, Xanax, tamoxifen, omeprazole, vitamin D, multi vitamin, fiber pill. Calcium pill.",None,None,,"Penicillin, sulfa, iphrofin","['Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain in extremity']",1,MODERNA,SYR 932200,IN,51.0,M,"3 hours after 2nd dose almost fainted when exercising. 4 hours after injection started to feel achey, headache, and stiff neck. 12 hours after injection started shivering and increased heart rate. Took advil which helped, but shivering resumed 18 hours later. Took more advil. Body aches, sore arm, and headache continued for 48 hours. I still don't feel great 48 hours later but much better",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,OTH,"Losartan, amlodapine, niacin, Armour thyroid, Claritin, vit d, vit b12,",No,"High BP, high cholesterol",,No,"['Chills', 'Feeling abnormal', 'Headache', 'Heart rate increased', 'Musculoskeletal stiffness', 'Pain', 'Pain in extremity', 'Presyncope']",2,PFIZER\BIONTECH,SYR 932201,TX,21.0,F,"Fever (lowest: 99.7, highest: 101.7), fatigue and headache for about 30 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PHM,Junel Fe,,Asthma,,"Mold, pet dander","['Fatigue', 'Headache', 'Pyrexia']",1,MODERNA,IM 932202,IN,43.0,F,Swollen lymph gland under left arm on day 2. Began sometime in the night.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,OTH,"Lexapro. Crestor, losartan potassium,oxybitynin cl er, amlodine besylate",Food poisoning,High blood pressure,,None,['Lymphadenopathy'],1,MODERNA,SYR 932204,FL,69.0,M,Diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PUB,"Metoprolol, Lisinipril, Plavix, glimepiride, morphine sulfate, atorvastatin, nitroglycerin",None,"Hypertension, DM2, chronic pain, hyperlipidemia, angina",,None,['Diarrhoea'],1,PFIZER\BIONTECH,IM 932205,KY,64.0,F,"Heart palpitations around 9:30 pm and again around 11:30 pm, fatigue lasting 2days, slight upset stomach, and dull headache for 2days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Benazepril, hydrochlorothiazide, atorvastatin, vitamin D, Omeprazole, allergy medicine generic to zyrtec",None,High blood pressure,"Shingles vaccine, age 64, vaccination date 10/30/2020, flu like symptoms for 2days",None,"['Abdominal discomfort', 'Fatigue', 'Headache', 'Palpitations']",1,MODERNA,SYR 932206,IN,25.0,F,Chills Night sweats,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,Fluoxetine Trazadone,,,,,"['Chills', 'Night sweats']",2,PFIZER\BIONTECH,IM 932207,IN,26.0,F,"Myalgias, joint aches, nausea, severe rigors and chills starting about 12 hours after administration of vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Aleve,None,None,,None,"['Arthralgia', 'Chills', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,IM 932208,IN,66.0,F,Sore Arm Headache all day the day after shot,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PUB,Estradiol Vitamin D Multi Vitamin,None,None,,Sulfa,"['Headache', 'Pain in extremity']",1,MODERNA,IM 932209,,26.0,M,"The morning after vaccination patient developed full body muscle aches, a migraine, and fatigue. Ibuprofen was taken and symptoms lessened over 6 hours, they resolved by 01/10/2021. Patient developed severe nausea the morning after vaccination (this also occurred after the first dose), and patient vomited several times with severe retching for 30 minutes. No medication was taken and symptoms subsided after 6 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,none,none,Asthma,The same events occurred within the same time frame following the first dose of the Pfizer COVID-19 vaccine.,"Lime, oranges, basil","['Fatigue', 'Migraine', 'Myalgia', 'Nausea', 'Retching', 'Vomiting']",2,PFIZER\BIONTECH,IM 932210,PR,56.0,M,"Next morning after vaccination (01/09/2021), I woke up to a slight ""buzz"" in both ears. They sound can be described as similar to the background noise produced by insects at night. Buzz intensity is low but persistent.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,OTH,"Atorvastatin 10mg (Oral), Latanoprost 0.005% (Ocular)",None,None,,Aspirin (Salicylic Acid - Salicylates),['Tinnitus'],1,MODERNA,IM 932212,KY,32.0,F,"Chills, fever of 102, body aches, and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,OTH,None,None,Migraines,,"Cechlor, Zoloft, and strawberries","['Chills', 'Fatigue', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932214,IN,58.0,F,"Fever of 102.6,chills, achiness, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,Amlodopine Levothyroxin Diclofenic Venlafaxine Gabapentin,Had covid 12/10 was my positive test,Hypertension Hypothyroidism,,None,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,SYR 932215,,39.0,F,"Nausea, dry heaves, hot, dizziness after 12 minutes . Observed for 40 minutes. Gave water and snacks. BP 121/83, HR 98. Resolved after observation. Husband picked up her.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/10/2021,01/10/2021,0.0,PVT,,,,,,"['Dizziness', 'Feeling hot', 'Nausea', 'Retching']",1,PFIZER\BIONTECH, 932217,NC,43.0,F,"Patient experienced headache, muscle aches in the neck and back, and a sore throat. Symptoms were moderate in severity. Patient self-treated with ibuprofen. Symptoms resolved approximately 24 hours after onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,Oral contraceptive,None,None,,None,"['Back pain', 'Headache', 'Myalgia', 'Neck pain']",2,PFIZER\BIONTECH,IM 932218,SD,30.0,F,"The day after I received the second dose, I experienced arthralgia, chills, fever, and muscle aches. The second day after the vaccine, those symptoms were much relieved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,Spironolactone Metformin Multivitamin,,PCOS,,NKA,"['Arthralgia', 'Chills', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932219,NC,66.0,F,"On day 2 left arm very sore and area around injection site became red and swollen. Day 4 no soreness at site and redness / swelling had abated. Night of day 6 soreness, swelling and redness at injection site returned. and is hot to touch and this continues on Sunday January 10th ( day 9). Red area is 2 in by 2 in in size.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PUB,"Tylenol Arthritis, Fexofenadine, Pantoprazole, Biotin, Calcium, Magnesium, Zinc, Vitamin D3 , Xiidra., Estradiol Probiotic. On December 1, I had a steroid injection in thigh.",UTI,"Arthritis, dry eye, Gerd",Onetime event with flu and tetanus vaccination s years ago. Red around vaccination site for 1-2 days. I have continued to get t,"Sulfa, Penicillin, Ibuprofen, Demerol, Aspirin and Wheat","['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 932221,OH,53.0,F,"Approx 48 hrs after receiving vaccine, slight rash appeared in 4 areas of the Left side(same side as vaccine) as follows- Left forearm, Left mid thigh. left top of foot and left upper breast/chest area. In all but chest area, the appearance was a single pustule that was light pink/red and itchy and then opened and drained. The chest area was the same in appearance but had 4 pusules. Immediate area around sites remained normal in color.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,OTH,"Methamazone 5mg once daily ,Vitamin D3 2000 IU, Multivitamin once daily",,Graves disease,,,"['Purulent discharge', 'Rash', 'Rash erythematous', 'Rash pruritic', 'Rash pustular']",1,MODERNA,IM 932223,OH,33.0,F,"Site was slightly red, swollen and warm after receiving vaccine. One week after (1/5/21) I developed a raised hive-like itchy rash- I used over the counter hydrocortisone cream. The next day (1/6/21) my upper arm was very red and swollen- I put Benadryl cream on it over night and it looked much better the next day. The redness and swelling has gone away, but the site is still slightly warm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,WRK,"Advair, omeprazole, Multi-vitamin, pro-biotic, b6",,Asthma,,"Flax, Ginger","['Injection site erythema', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Rash papular', 'Rash pruritic', 'Urticaria']",1,MODERNA,IM 932224,IL,49.0,F,Fever 102 Body aches Chills Headache Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,SCH,Vitamin B12 Pantoprazole Concerta,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 932225,,23.0,F,Pain in L armpit region. Axillary lymph node swelling.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/09/2021,5.0,UNK,,,,,,"['Axillary pain', 'Lymphadenopathy']",1,MODERNA,SYR 932227,FL,71.0,F,Soreness in right arm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,Trileptal Lamictal Latuda Gabapentin Ambien B12,None,Bipolar,,None,['Pain in extremity'],1,MODERNA,IM 932228,IN,35.0,U,"Fever to 101, tachycardia to 123, headache, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Fatigue', 'Headache', 'Pyrexia', 'Tachycardia']",2,PFIZER\BIONTECH,IM 932230,IN,54.0,M,"100.1 fever, chills, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Metformin 500mg Atorvastatin 40mg,,,,,"['Chills', 'Headache', 'Pyrexia']",1,MODERNA,IM 932265,IN,32.0,F,"Erythematous and pruritic rash to BUE, chest and upper back",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/10/2021,2.0,WRK,"Vyvanse, pristiq, montelukast",None,ADD,,None,"['Rash erythematous', 'Rash pruritic']",2,PFIZER\BIONTECH,SYR 932266,OH,63.0,M,"Headache, tiredness, and lethargy the following day. Dissipated by evening.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Motrin, CBD Oil, Glucosamine/Chondroitin",None.,None.,,None.,"['Fatigue', 'Headache', 'Lethargy']",1,PFIZER\BIONTECH,IM 932267,NE,33.0,F,"On 1/6/2020 my arm began to itch and I developed a baseball size red, swollen circle on my arm at the site of injection. It was warm to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/06/2021,8.0,WRK,Colanzempam,,Endometriosis Anxiety,,Zofran,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Pruritus']",1,MODERNA,SYR 932268,IN,33.0,F,"Severe headache different in nature from my normal migraines and not relieved by taking rizatriptan. Pain was throbbing and pressure in nature, 8/10 lasting approx. 10 hours. Also experienced fatigue during same time frame.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Cymbalta 60mg/day Spirinolactone 100mg/day Vit. D 4,000 IU/DAY Probiotic Rizatriptan 10mg as needed for migraine, not taken on day of vaccination",None,Migraines Anxiety Depression Sleep apnea,,Penicillin,"['Fatigue', 'Head discomfort', 'Headache']",1,MODERNA,IM 932269,CT,52.0,F,"red rash noted around injection site, slight itching",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/03/2021,8.0,PVT,none taken,none,none,,no allergies,"['Injection site pruritus', 'Injection site reaction', 'Rash erythematous']",1,MODERNA,IM 932270,IN,25.0,F,"Almost exactly 12 hours after receiving the second dose of COVID vaccine, I woke up from sleep curled into a ball, covered in sweat, absolutely freezing, teeth chattering, and all my muscles were shaking violently. I tried to roll over in bed and all of my muscles locked up and I began to convulse even stronger. This made me feel extremely nauseous and then I began to vomit. I know I had a high fever but I was unable to keep down any medications as I kept vomiting. I felt ill like this for the next 24 hours, with a 100.1 fever even after rounds of ibuprofen and tylenol, and severe muscle soreness and achiness, and headache. I also have intermittent nausea and will occasionally vomit bile. I finally woke up on 1/10/2020 and don?t have a fever, but my body feels very beat up and sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,"Lexapro 20 mg, omeprazole 20 mg, birth control pill, daily multivitamin, daily probiotic, daily allergy",None,None,,"Sulfa drugs, amoxicillin, penicillin","['Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Malaise', 'Myalgia', 'Nasopharyngitis', 'Nausea', 'Pain', 'Pyrexia', 'Seizure', 'Sleep disorder', 'Tremor', 'Vomiting']",2,PFIZER\BIONTECH,SYR 932271,CO,27.0,F,"3 inch red circle at injection site, red, swollen, itchy, warm raised circle.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/10/2021,11.0,PVT,Kyleena IUD,None.,None.,,None.,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 932272,IN,59.0,F,"Temperature 99.4, severe body aches, chills, soreness at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Novolog insulin, lisinopril, ezetemibe",No,"Diabetes, hypertension",,No,"['Body temperature increased', 'Chills', 'Injection site pain', 'Pain']",1,PFIZER\BIONTECH,IM 932273,IN,58.0,M,"Fever, Chills, headache, body ache. Tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,UNK,No,,None,,Tylox,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA, 932274,IN,42.0,F,"Fever, chills and body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Valtrex,,,,,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932275,IN,45.0,F,Diarrhea started about 6:30 pm followed by body aches. Within 2 hours I had chills. About 3 am I had a fever of 99.9 degrees F ( normally 97.2 for me). The next day I had a headache and felt fatigue. I had diarhea 3 more times. My spine ached a little when I went to bed about 11pm. No side effects by 1/10/21,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Pepcid TRINTELLIX,None,Depression Acid reflux,,None known,"['Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Pain', 'Pyrexia', 'Spinal pain']",2,PFIZER\BIONTECH,IM 932276,NC,41.0,F,"Warm sensation in chest 10 minutes after receiving vaccine, tight feeling in face 30 minutes after vaccine, tingling numbness in face 1 hour after vaccine, warm and tingly feeling down back between shoulder blades 1 hour 30 minutes after vaccine, ears felt warm and ringing 3 hours after vaccine, cool tingly feeling on entire back 8 hrs after vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,MVI,None,None,,"Penicillin, Levofloxacin, bees","['Chest discomfort', 'Feeling cold', 'Feeling hot', 'Hypoaesthesia', 'Paraesthesia', 'Skin tightness', 'Skin warm', 'Tinnitus']",1,MODERNA,IM 932277,NJ,37.0,F,"1220p- received IM vaccine 1130p- woke up with shortness of breath, chills/rigors, and moderate body aches. Afebrile at this time. Took Tylenol 1000mg PO and went back to sleep. 1/9/21- 945a- Body aches had been improving but progressively getting worse at this time. Tylenol 1000 mg PO taken again. Remained afebrile. 245p- Chills started again, body aches continued. Temp= 100.6. Tylenol 1000mg PO taken. 1/10/21- 630a woke up for the day and continued to have body aches. Temp = 100.9, took Tylenol 1000 mg PO. 730a- reported symptoms to work occupational health and told could return when afebrile without Tylenol and cleared by them. Will continue to monitor symptoms. 730p= Chills and body aches continued. Temp= 101.9. Took Tylenol 1000mg PO and went to bed for the day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,OTH,Mirena IUD,None,"Ovarian cysts, GERD",,"PCN- hives, shortness of breath Sulfa- muscle weakness","['Body temperature increased', 'Chills', 'Dyspnoea', 'Impaired work ability', 'Pain']",2,PFIZER\BIONTECH,IM 932278,IN,37.0,F,"Body aches, 1 day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,UNK,None,None,None,,None,['Pain'],UNK,PFIZER\BIONTECH,IM 932279,NY,36.0,F,"lightheaded and dizzy, extremely tired which started 5 days after the injection. on January 9th noticed a large red area on the left arm below the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/05/2021,5.0,WRK,,,,high fever after being given the MMR shot,amoxicillin and bactrim,"['Dizziness', 'Erythema', 'Fatigue']",1,MODERNA,IM 932280,KY,29.0,F,"Symptoms appeared on 12/31/20 with a sore arm, redness, warmth, and swelling at injection site. The reaction began to spread for the next 5 days. Throughout this time I was putting ice on it, taking Motrin, Benadryl, and applying hydrocortisone cream. The reaction went away for 2 days (1/5/21 and 1/6/21). The reaction then came back on 1/7/21. I went and saw my healthcare provider on 1/7/21, and was told it was a localized reaction and to continue to monitor it. I still have this reaction to this day, 1/10/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,Magnesium Coenzyme Q10 Vitamin B2 Xyzal Rizatriptan Flonase Junel,,Migraines,,"Lortab, Egg, Kenalog","['Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Local reaction']",1,MODERNA,IM 932281,IN,32.0,F,"Low grade fever, Chills, Headache. Improved with Tylenol initially. Resolved after 12 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,OTH,Tylenol,None,None,,None,"['Chills', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,SC 932282,MN,59.0,M,"All That you describe. What are the risk of the PFIZER Vaccine. injection site pain tiredness, Severe headache, muscle pain, severe chills, slight fever, injection site swelling, nausea, pain in crest area and lung pain. When taking deep breaths the lung issue would diminish.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,"Atorvastatin 10 mg Tamsulosin HCL 0,4 Oxybutynin 5MG taking 2",None,None. Part time Health care worker at Health Care System.,,Unk,"['Blood magnesium normal', 'Chest X-ray normal', 'Chest pain', 'Chills', 'Computerised tomogram thorax', 'Electrocardiogram', 'Fatigue', 'Full blood count', 'Gaze palsy', 'Injection site pain', 'Injection site swelling', 'Lipase normal', 'Metabolic function test', 'Myalgia', 'N-terminal prohormone brain natriuretic peptide', 'Nausea', 'Pulmonary pain', 'Pyrexia', 'SARS-CoV-2 test', 'Troponin normal']",1,PFIZER\BIONTECH,SYR 932283,IN,52.0,F,"Extreme fatigue, muscle aches, slight fever (99.0) and right arm soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"HCTZ, lisinopril, vit D, Wellbutrin, amlodipine, metformin, fish oil,",None,None,,None,"['Fatigue', 'Myalgia', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932284,NE,48.0,F,"Neck tightness, SOB, and throat swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/10/2021,,,UNK,"Vitamin D 50,000, Lexapro 10mg Daily, Vistaril 25mg Daily, Propranolol 10mg Daily, Venlafaxine 37.5mg",,,,,"['Dyspnoea', 'Muscle tightness', 'Pharyngeal swelling']",UNK,PFIZER\BIONTECH, 932285,NC,46.0,M,"Fever, Flu like symptoms., chills/sweating for 72 hrs, Body aches and severe joint pain, disorientation, severe anxiety and jittery, rapid heart rate, Resting heart rate was between 130-140 beats per minute. Severe fatigue and weakness. Stayed in bed for 48+ hrs after adverse symptoms began with little relief.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,"aspirin 80mg. Janumet, Avorstatin",none,none,,Penicillin,"['Anxiety', 'Arthralgia', 'Asthenia', 'Chills', 'Disorientation', 'Fatigue', 'Feeling jittery', 'Heart rate increased', 'Hyperhidrosis', 'Influenza like illness', 'Pain', 'Pyrexia']",1,MODERNA,IM 932286,NY,26.0,F,"About 30 minutes after vaccination, patient notiched itchiness which progressed to hives on her bilateral arms and face. Around two hours after the vaccination while on the phone with our covid vaccine team, she developed tachycardia and shortness of breath. She called EMS and was evaluated at home at which time her symptoms were improving. They advised that she was not having anaphylaxis and could stay at home. She went to urgent care and received PO Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,,,None,"['Dyspnoea', 'Pruritus', 'Rash', 'Tachycardia', 'Urticaria']",UNK,PFIZER\BIONTECH, 932287,KS,32.0,M,"Potential Bell's Palsy 8 days post Pfizer BioNtech COVID19 Vaccine Dose #1 Per documentation from emergency department provider: 32 y/o M who comes in from home for a new onset facial droop. Pt states that this is sudden onset today. he is unsure if it is related to the recent covid vaccine but has otherwise been well. He has no recent viral sx. He has no other neuro sx. He did have some pain in the jaw at the onset but that has since resolved. CT head obtained more for the jaw pain and to ensure no mass etc. It is normal. I discussed at length with the pt that I suspect this is bells palsy as he has very minimal movement of the forehead, cannot fully blink the L eye closed and has no risk factors for stroke. I did offer him further imaging to make 100% sure this is not a stroke but he agrees that he feels he has bells palsy and declined further labs or imaging. i will have him f/u with ENT as an OP. Given return precautions and f/u with them in the office. Given first dose of steroids and valacyclovir here. He will use artificial tears and tape the eye at night. .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/25/2020,12/25/2020,0.0,PVT,cyclopbenzaprine as needed,None,"History of anxiety, depression.",,NKA,"[""Bell's palsy"", 'Computerised tomogram head', 'Corneal reflex decreased', 'Facial paralysis', 'Movement disorder', 'Pain in jaw']",1,PFIZER\BIONTECH,IM 932288,FL,72.0,F,Sore arm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,atenolol amlodipine besylate ezetimibe prilosec vitamin D3 vitamin C,,,"Flu vaccine, many years ago. Had fever and chills 24 hours",,['Pain in extremity'],UNK,PFIZER\BIONTECH, 932289,CT,35.0,F,"25min after injection while driving home, I got a cold sensation in the back of my head, trouble breathing, racing heart, and lightheadedness. pulled over, paramedics called. no treatment, symptoms passed after 30min. (cold sensations, racing heart, and trouble breathing brief, lightheadedness ~30min)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,none,none,"infertility, ivf",,penicillin,"['Dizziness', 'Dyspnoea', 'Feeling cold', 'Palpitations']",1,PFIZER\BIONTECH,IM 932291,IN,67.0,F,Started out with nausea and sore arm site felt hot. Then I started running a fever of 100.4 slept most of day then I had a headache took excedrin migraine went back to bed. When I got up fever was 99.4 had diarrhea and fever lasted rest of the night . Sunday morning got up felt a little better.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Snythroid, pravastatin, spironolactone, allegra montelukast, daily vitamin, amitriptyline, progesterone and estradiol patch",None,None,,None,"['Diarrhoea', 'Headache', 'Injection site warmth', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 932292,CT,62.0,F,"Pain at injection site, fever of 102.5",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/10/2021,9.0,PVT,"Tylenol, Motrin, Levothyroxine",One,"Migraine, emphysema, hypothyroidism",,"Celebrex, bacitracin","['Injection site pain', 'Pyrexia']",1,MODERNA,IM 932293,IL,36.0,M,Severe debilitating chills. Worse than any previous infection experienced. Unable to move. Mildly improved with Motrin. Had low grade 100.3 F fever. Weakness aches lymphadenopathy. Severity of symptoms of reduced from severe to mild in just over 48 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Asthenia', 'Chills', 'Lymphadenopathy', 'Mobility decreased', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932294,AZ,70.0,F,"Initially developed mild injection site soreness. Two and a half days later, developed abdominal cramping, bloating, severe diarrhea, muscle aches (especially legs and back), headache, rigors, fevers (high was 103 oral), decreased sats to 91% (normally 98 to 99). Profound weakness. Was in bed for 2.5 days. Took 4 days to recover fully.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,PUB,"Simvastatin, hydrochlorthiazide, lisinopril, montelukast, loratidine, Areds, aleve, vitamin D",None,Mild asthma and allergies.,,Cats. Dogs. Hay.,"['Abdominal distension', 'Abdominal pain', 'Asthenia', 'Chills', 'Diarrhoea', 'Headache', 'Injection site pain', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 932295,VA,30.0,F,"Work up on Wednesday with sore throat, head fog, and fatigue. Could not work wed or thurs, worked Friday morning and felt better. Saturday experienced fatigue. Sunday woke up with larger swelling and redness near injection site. Took ibuprofen and allergy pills throughout. Used neosporin on injection site on Sunday morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/06/2021,4.0,UNK,Flo PMS regulating gummies,None,None,,"Cats, seasonal","['Fatigue', 'Feeling abnormal', 'Impaired work ability', 'Injection site erythema', 'Injection site swelling', 'Oropharyngeal pain']",UNK,MODERNA, 932296,IN,50.0,M,Massive headache and chills!,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/10/2021,2.0,PUB,,,,,,"['Chills', 'Headache']",2,PFIZER\BIONTECH,SYR 932297,IN,28.0,F,"- Mild arm muscle pain about 5 min after the vaccine (second dose). - 6-30 hours - progressive myalgias and arthralgias, fatigue - 24 hours max temp 99.9, chills, sweats - Symptoms all resolved by 36 hours after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,None,,None,"['Arthralgia', 'Body temperature increased', 'Chills', 'Fatigue', 'Hyperhidrosis', 'Myalgia', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 932298,CT,49.0,F,"1/8/2021 Friday: I started to have bad chills and fever 100, around 10pm that evening after the vaccine. 1/9/2021 Saturday: I was really sick with fever 101.2, chills, headache, body aches, nausea, weak, no appetite, sore arm at vaccination site and tired. 1/10/2021 Sunday: 12AM woke up soaking wet from head to toe BUT felt ok. Still sore in my arm. As of 10:30AM I feel ok so much better than yesterday.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,None,Covid-19 (12/12/2020),None,,None,"['Asthenia', 'Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Illness', 'Nausea', 'Pain', 'Pyrexia', 'Vaccination site pain']",1,MODERNA,SYR 932299,IN,25.0,F,"Fever, chills, nausea, vomiting, diarrhea, joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Trintellix,None,Anxiety,,Amoxicillin,"['Arthralgia', 'Chills', 'Diarrhoea', 'Nausea', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 932300,IN,46.0,F,Sore to injection site-first day Palpitations up to 120bpm in resting lasting 4-5 hours-second day,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/17/2020,1.0,UNK,,,,,,"['Injection site pain', 'Palpitations']",UNK,PFIZER\BIONTECH,IM 932301,MD,24.0,M,"Headache, muscle aches, and fever reaching 101.8 started at around midnight of 1/9/2021, roughly 8 h after receiving the vaccine. The fever broke this morning (1/10/21) so a rough estimate of the time course is 32 h. The fever was also reduced with acetaminophen. The headache still persists, albeit milder. The muscle aches resolved with the fever, so a time course for that would also be 32 h. I recently had a COVID19 infection (symptom onset was 12/25/20), but had cleared my isolation date of 1/4/21. The symptoms from my COVID19 infection (headache, muscle aches, chills) had virtually resolved by 1/8/21 before I received the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,SCH,None,COVID19 with sx onset on 12/25/20,None,,None,"['Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 932302,OH,38.0,F,"Almost two weeks post injection, injection site became red, hot, and itchy. Size of reaction is about the size of a large apple. Area beneath injection site is extremely hard, and again, hot to touch. Smaller blister appeared today. Otherwise, I am fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"Metformin, Irbesartan-Hydrochlorothiazide, Amlodipine, Trazadone, Welbutrin, Celexa, Claritin",None,"Asthma, anxiety, chronic uti",,Codeine,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 932303,MI,49.0,F,"Approx 10 hrs after injection severe left arm pain, progressed to all over body aches about 12 hrs post vaccination. Approx 24-30 hrs post vaccination chills and slight headache added and remained until approx 48 hours post. Took Motrin for aches and rested with restricted movement",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,Metoprolol Venaflexine Wellbutrin Omeprazole Motrin 800,None,PVC Gurd History of ovarian cancer Shoulder surgery on 10/27,,None,"['Chills', 'Headache', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 932304,IN,27.0,F,"Diffuse myalgia and Arthralgia, fatigue, headache, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,None,,None,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH,IM 932305,IL,59.0,M,Slight headache and sore arm so far over 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PUB,"Finasteride, Tamsulosin, Fluticasone Propionate, Zyrtec, Montelukast",None,Enlarged Prostrate,,None,"['Headache', 'Pain in extremity']",1,MODERNA,SYR 932306,CO,27.0,F,"10 days later, developed a 3? round circle directly around injection site. The circle is red, raised, hot to the touch and has not gone away. I also am experiencing some itchy ness on the right arm radiating to my chest and back. My back has also developed a minor rash with itchy ness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/09/2021,10.0,PVT,Kyleena IUD,,Inappropriate sinus tachycardia,,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Pruritus', 'Rash']",1,MODERNA,SYR 932307,SC,36.0,F,"Lethargy, Headache, Sore arm, Body aches for 36 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,"Apri 28, Effexor XR, Claritin",None,None,,Compazine,"['Headache', 'Lethargy', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 932308,MD,62.0,M,Severe chronic left shoulder joint pain and stiffness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PUB,glucosamine/chondroitin,none,"gastroesophageal reflux, high cholesterol",,none,"['Arthralgia', 'Joint stiffness', 'Pain', 'X-ray limb']",1,MODERNA,IM 932309,FL,69.0,M,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/10/2021,01/10/2021,0.0,PVT,no,no,no,,no,['Unevaluable event'],UNK,PFIZER\BIONTECH, 932310,,46.0,F,"Chills, feverish, headaches, muscle pain, joint pain severely fatigue lasted ~ 12 hours .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 932311,IN,32.0,F,"Fever, chills, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Malaise', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932312,OH,44.0,F,"Face swelling 1st 6 hours. First night ( bilateral pinky fingers and right thumb) and every night thereafter right thumb locked up during the night, then moves in trigger thumb motions when attempting to move. Goes away during day but reoccurs every night. Sudden onset the night of vaccination with no previous episodes. Dr appointment made 10 days later due to symptoms not getting better. Dr ordered bracing for wrist and thumb at night and 10 mg of meloxicam daily. Im on day 3 of tx. This was the first morning I woke with milder locking up and trigger thumb symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,SEN,"10 mg singular , 1000 mcg B12, 12 grams collagen, woman's 1 daily, ferrous sulfate 325 mg, vitamin C 500 mg, biotin 10000 mcg",Asthma,"Asthma, anemia",,"Shrimp, latex","['Swelling face', 'Trigger finger']",1,PFIZER\BIONTECH,SYR 932313,IN,39.0,F,"Headache, fatigue, body ache, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Multivitamin, Mirena IUD, setraline 50mg",None,Anxiety,,None,"['Fatigue', 'Headache', 'Malaise', 'Pain']",2,PFIZER\BIONTECH, 932315,IN,61.0,F,"Numb hands, numb face, lightheaded, almost passed out, spike in blood pressure, unsteady walk. Ambulance called, tested to rule out stroke and blood sugar issue but tested ok. Determined I had allergic reaction to vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,None,,"Codein , sulfa drugs","['Dizziness', 'Gait disturbance', 'Hypersensitivity', 'Hypoaesthesia']",1,PFIZER\BIONTECH,SYR 932316,IN,28.0,F,"Soreness in left arm by injection site 6-24 hours after shot Chills, fever, weakness 12-30 hours after shot",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,None,No,No,,None,"['Asthenia', 'Chills', 'Injection site pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 932317,IN,23.0,M,"I had injection site pain about 4 or 5 hours after my injection. Around 9:15 at night I felt slightly warm and could tell that I was becoming febrile, but I wasn't completely there yet. Around 12:45AM on January 9th, I had massive chills and uncontrollable shivering and muscle aches. I took 1000 mg of acetaminophen. I took another 1000 mg of acetaminophen at 6:00AM when my chills came back. At 10:45AM I was feeling febrile again, and took 600 mg of ibuprofen followed by an hour and a half nap. I had slight malaise afterwards but did not feel febrile. By 5PM, I was feeling almost completely normal and was fever free. On the morning of 1/10, I am completely recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Omeprazole,None,None,,None,"['Chills', 'Feeling hot', 'Injection site pain', 'Malaise', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932318,MN,47.0,F,"Hypertensive event: 11:30 p.m. 12/31/2020 blood pressure spiked to 175/110. Normal BP range is 130-145/80-90. Heart Rate: 110 bpm. Normal range is 60-85 bpm. TREATMENTS: Initial: rest; OTC ginger, turmeric, CoQ 10, garlic supplements -- Outcome: BP lowered to 165/110, HR: 110 bpm 01/01/2021: continued treatment -- Outcome BP lowered to 155/100, HR: 100-110 bpm 01/02/2021: added in Pamabrom 50 mg (2 doses 6 hours apart) -- Outcome BP lowered to 145/90, HR: 90-110 bpm Continued treatment 01/03/2021-01/10/2021 with BP results ranging from 120-145/95-110, HR: 80-110 bpm As of 01/10/2021 BP still not returned to baseline and treatment continued with Dr appt pending",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,"L'il Critters Immune C plus zinc & vitamin D x3 (total of C: 180 mg, D: 15 mcg, zinc:3.6 mg) Dimetapp Immune support (total of C: 90 mg, D: 3.1 mcg, E: 3.3 mg, zinc: 1 mg, and elderberry juice 69 mg) fexofenadine hydrochloride 180 mg",None,Exercise induced asthma Obesity Class 2,,Hayfever seasonal allergies,"['Heart rate increased', 'Hypertension']",1,MODERNA,IM 932319,CT,44.0,M,"One day after vaccination: Muscle aches entire body. Second day after vaccination: still muscle aches, with one event of vomiting and chills in the morning. No fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,"Vitamin C, Vitamin B12",None,High Blood Pressure,,none,"['Chills', 'Pain', 'Vomiting']",UNK,MODERNA,IM 932320,IN,41.0,F,fever of 101F that began approximately 12 hours after vaccine administration and lasted less than 24 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,,,"fever of 102F, age 41, occurred after first dose of Pfizer COVID-19 vaccine on 12/18/2020",,['Pyrexia'],2,PFIZER\BIONTECH,IM 932321,FL,31.0,F,"Minutes after the vaccine I got a tingling sensation on my skin that moved around all over my body. This lasted about 30 minutes. My arm, at the injection site, was very sore for 2-3 days after. On 1/08/21 I noted a small red spot at the injection site that I thought was a bruise; however, on the evening of 01/09/21 I noticed it had grown to approximately 3 inches in diameter. It was red, a little swollen and a little itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,Levonor-ETH ESTRAD Sumatriptan SUCC 50mg PRN (taken once since vaccine) mykind organics women's once daily whole food multivitamin Fish oil 500mg allergy shots biweekly,migraine once since vaccine,sensorineural hearing loss scoliosis pinched nerve in neck,Whooping cough vaccine,"pertussin benzol peroxide dairy intolerance environmental allergies (grass, trees, animals, etc.)","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Paraesthesia']",1,MODERNA,SYR 932322,KS,32.0,M,Anaphylaxis Please note previous VAERS report of Bell's Palsy 8 days following the first dose and subsequently treated with prednisone and valacyclovir. This neurologic diagnosis was not reported by the patient during the consent process with the COVID19 vaccination center staff. Confirmed following review of the consent form. Documentation from Emergency Department Provider: Patient is serially reassessed following treatment for anaphylaxis. Patient has significant improvement in diffuse erythema and hives within 20 minutes. He has gradual improvement in his sensation of throat swelling. He is observed while in the emergency department serially over 4 hours with no recurrence of symptoms. He does not require any repeat dose of epinephrine and feels at baseline. Discussed my suspicions that patient may have had a reaction to COVID-19 vaccine as he has had no other new medications or exposures that he is aware of. As he will not be receiving another vaccine there is nothing to necessarily stay away from. Make sure he notifies individuals about this for any new vaccine should he receive them. Patient is observed for sufficient time but discussed possibility for biphasic reaction. Recommend he return should he have recurrence of symptoms. Recommend he take EpiPen as prescribed for any throat swelling or progressive shortness of breath. Recommend follow-up with a primary care provider for this visit..,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,PVT,cyclobenzaprine prn,None,History of anxiety and depression,COVID19 Pfizer-BioNtech (see previous VAERS report),No known allergies,"['Anaphylactic reaction', ""Bell's palsy"", 'Erythema', 'Pharyngeal swelling', 'Urticaria']",2,PFIZER\BIONTECH,IM 932323,IL,48.0,M,"Arm soreness, chills, fatigue, headache lasted 24 hours. Had same reaction to the first dose, almost identical.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Pain in extremity', 'Vaccine positive rechallenge']",2,PFIZER\BIONTECH,IM 932324,TX,56.0,F,"Gradual increasing severe pain and Severe Left arm pain gradually increasing over 36h period, as well fatigue, night sweats, all over muscle pain, severe left temporal headache, cold shivers, upset bowels",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,None,None,Arthritis,Phenergan-Anaphalactic shock >45 years prior at age 8,Phenergan,"['Chills', 'Fatigue', 'Headache', 'Irritable bowel syndrome', 'Night sweats', 'Pain', 'Pain in extremity']",1,MODERNA,IM 932325,SC,39.0,F,"1/5/21 started with fever (up to 101), severe body aches, shaking from being cold even bundled with electric blanket, nausea and vomiting. That lasted through 1/8. On 1/7 I started having trouble with taking a deep breath. Chest would get very tight and hurt when I would take a big breath, bend forward, or lay back. I went to express care and they could not rule out pericarditis. Told me to go to the Emergency Room for further work up to rule out spontaneous PE or pericarditis.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,"Plaquinel, b12, Flonase,",None,SLE,,NKDA,"['Chest X-ray', 'Chest discomfort', 'Chills', 'Electrocardiogram', 'Nausea', 'Pain', 'Painful respiration', 'Pericarditis', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 932326,NC,57.0,F,"ON 1-7-21 IN THE EVENING, PATIENT STATES SHE STARTED WITH A DULL ACHE IN HER LEFT THIGH THAT COMES AND GOES. SWOLLEN NYMPH NODES. MILD TINGLING IN FOOT.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,PUB,"GLIPIZIDE, CAXENDA",NONE,DIABETES,,NKDA,"['Lymphadenopathy', 'Pain in extremity', 'Paraesthesia']",1,MODERNA,IM 932327,GA,51.0,F,Severe migraine 24 hours after the second vaccine Very swollen lymph nodes in the arm pit of the arm that received vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,WRK,Trulicity Metformin,None,Diabetes,,None,"['Lymphadenopathy', 'Migraine']",2,PFIZER\BIONTECH,IM 932328,IN,31.0,F,"Body aches, chills, joint pain and arm pain. Lasted for 10 hours roughly",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Arthralgia', 'Chills', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH, 932329,FL,73.0,M,"The vaccine was taken on Tuesday afternoon. Three hours later the vaccine arm started hurting. On Wednesday morning slight headache, tiredness, muscle pain, arm pain. Wednesday night Nausea and dizzines until Thursday around 10 AM. Felt well and still some arm soreness. I took Tylenol for the headache once.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/05/2021,4.0,OTH,"Multivitamins, Losartan 50 mg, Fish oil, Levothyroxine .05 mg",None,None,,None,"['Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 932330,IN,30.0,M,"Headache beginning 18:30 PM on 01/08 Following began at 03:30 on 01/09: Headache Body aches Severe muscle cramps Weakness Fatigue Chest tightness Inability to concentrate Difficulty sleeping Blurred vision Treatments: Ibuprofen 400 mg at 18:30 01/08 - headache responded Ibuprofen 800 mg at 07:00 01/09 - chest tightness had resolved spontaneously. Headache, body aches, cramps, visual disturbance, concentration, and chest tightness improved over next 4 hours Ibuprofen 400 mg at 11:30 01/09 - continued improvement of symptoms Naproxen 220 mg and ibuprofen 200 mg at 20:00 01/09 - continued improvement of headache and body ache symptoms with no return of overnight adverse events",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,None,None,None,,None,"['Asthenia', 'Chest discomfort', 'Disturbance in attention', 'Fatigue', 'Headache', 'Insomnia', 'Muscle spasms', 'Pain', 'Vision blurred']",2,PFIZER\BIONTECH,IM 932331,IL,34.0,F,"Fever, chills. Body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932332,VA,33.0,F,I started having Diarrhea and was fatigue that began the morning after the vaccine at 05:48 1/9/21 and continued throughout the day hourly until the following day 0030 1/10/21.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,None,None,Diabetes and hypertension,,None,"['Diarrhoea', 'Fatigue']",2,PFIZER\BIONTECH,IM 932333,NJ,52.0,F,"Headache hour after vacation, then as day progressed, continued headache, approx 4pm pounding headache, nausea, lightheaded, fatigue and just feeling bad. Next day dizziness, fatigue, headache and body aches. Symptoms continued with some shortness of breath. Nyquil taken at approx 5-6pm. 3rd day woke up had dizzy spell fell on the floor. Still having some fatigue lightheadedness and nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,SEN,"Nothing on the day of vaccination, nyquil on second day",Depression,Depression,,shellfish,"['Dizziness', 'Dyspnoea', 'Fall', 'Fatigue', 'Feeling abnormal', 'Headache', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,IM 932334,IN,49.0,F,"fever, chills, headache, overall aches. Started 11 hours after receiving vaccination. symptoms (although not as uncomfortable) still continuing at 42 hour mark",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,UNK,,,,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932335,TX,32.0,M,"With in 12 hours had muscle soreness in right arm, headache. Got weakness in arm for 2 weeks. Shooting pains in arm. Feels like a pinched nerve when the left arm in moved. Numbness in thumb.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,WRK,vitamin D,no,no,,no,"['Headache', 'Limb discomfort', 'Myalgia', 'Nerve compression', 'Pain in extremity', 'Paraesthesia']",1,PFIZER\BIONTECH,SYR 932336,NC,65.0,M,Fever up to 101 16 hrs post-injection. Severe myalgia and fatigue. Improving on day #2,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Ramipril, Sinemet, carvedilol, amlodipine, rosuvastatin, CoQ 10",None,"HTN, Parkinson?s",,None,"['Fatigue', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932337,VA,37.0,F,"Previous COVID 19 infection 2 weeks prior to 2nd vaccine. 8 hours after 2nd vaccine, muscle aches, chills, fever started. All symptoms persisted throughout the first night. Muscle aches, chills, and fever returned every 4 hours with alternation of Tylenol 650mg every 4 hours and Ibuprofen 600mg every 6 hours. Last fever was at 12:30pm on 1/9/21. Some chills without fever noted at 4am 1/10/21. Sweats and right arm soreness with localized redness to injection site have continued into 1/10/21 to the time of this report.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Lexapro, Wellbutrin, Chantix","First vaccine received on 12/18/20. No reaction. COVID 19 symptoms started 12/28/20, Positive test on 12/29/20. Symptoms lasted approximately 4 days. Returned to work on 1/8/21",Anxiety,,None,"['COVID-19', 'Chills', 'Hyperhidrosis', 'Injection site erythema', 'Injection site pain', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932338,IN,53.0,M,"Mild headache x 8 hrs Malaise, myalgias x 48 hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,,,Hypertension,,,"['Headache', 'Malaise', 'Myalgia']",2,PFIZER\BIONTECH,IM 932339,IN,57.0,F,Severe Migraine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,,COPD,,,['Migraine'],2,PFIZER\BIONTECH,IM 932340,IN,72.0,M,"This was my second vaccine for Covid. I experience headache, shaking chill and flu- like symptoms. My left arm was also sore. I had similar sx with the firat dose of the two but the second dose was definitley more symptomatic. My chillswere so bad that I could bvarely open the Tylenol container to get the medicine out. I should also state that I also had the Covid disease and I know that this is a risk factor for having a reaction. I think people should be told that they could have a reaction so they do not plan anything important the following day, but they should still get the vaccine. The day following the reaction I felt perfect.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,Niacin; Lisinopril,,hypertension ; prostate cancer in remission,flu like symptoms after shingles vaccine,none,"['Chills', 'Headache', 'Influenza like illness', 'Pain in extremity', 'Similar reaction on previous exposure to drug']",2,PFIZER\BIONTECH,IM 932341,TN,33.0,F,"Initially, I had a small bruise at the injection site (given on Wednesday afternoon). The following Wednesday I had what seems to be a delayed injection site reaction. I developed redness and itching around the area that lasted approximately 48 hours. I wanted to report in case others experience a delayed reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,PUB,"Sertraline, zinc, vitamin c, vitamin D, biotin",None,"Anxiety, depression, Irritable Bowel Syndrome (diarrhea)",,NKA,"['Injection site bruising', 'Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Skin reaction']",1,MODERNA,IM 932342,IN,60.0,M,"body aches, injection site soreness, joint stiffness, nausea, head ache, flu like symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Atorvastatin 10 MG tablet, Levocetrizine 5 MG Tablet, Pntoprazole SOD DR 40 mg tablet, B12 1000 mcg.",none,none,,none,"['Headache', 'Influenza like illness', 'Injection site pain', 'Joint stiffness', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 932343,SC,36.0,F,"Bell?s palsy the morning after the vaccination administration with left facial droop, left lip swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,UNK,"Cetirizine, levothyroxine, alycen",N/a,"Hypothyroidism, HLD, IBS",,Clindamycin,"[""Bell's palsy"", 'Facial paralysis', 'Lip swelling']",UNK,PFIZER\BIONTECH, 932344,IN,34.0,F,"Sudden onset Severe muscle ache, joint pain, diaphoretic, lightheaded, fever, nausea, fatigue. Approximately 24 hour duration. Acetaminophen administration with resolution of fever but no effect on other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,"Multivitamin, Vitamin C, Vitamin D3, Zinc supplement, flonase",None,None,,NKDA,"['Arthralgia', 'Dizziness', 'Fatigue', 'Hyperhidrosis', 'Myalgia', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,IM 932346,NC,66.0,M,"1/7-21 - Received second dose of pfizer covid-19 vaccine 1/8/21 - Fever, dizziness, headache 1/10/21 0250 was found not breathing. EMS performed CPR and patient deceased",Yes,01/10/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Unknown,none known,"hypertension, hyperlipidemia.",,Statin - muscle aches,"['Death', 'Dizziness', 'Headache', 'Pyrexia', 'Respiratory arrest', 'Resuscitation']",2,PFIZER\BIONTECH,SYR 932347,PA,51.0,F,"Low grade fever 100.2, severe body aches, fatigue, started around 8:00 pm 1/7/21, worsened throughout the night. Intense fatigue and body aches continued throughout 1/8/21. 1/9/2021, Fatigue , intermittent chills subside.,mild generalized body aches continue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,None,,"Sickle-Cell Trait, G6PD, Arthritis","Mild chills, moderate discomfort at injection site, fatigue","PCN, Sulfa, ASA products, Nuts","['Chills', 'Fatigue', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932348,NC,60.0,F,"HAD NO PROBLEMS UNTIL 1 WEEK LATER. ON 1-6-21, PATIENT DEVELOPED LUMP AT INJECTION SITE. REDNESS, WARM TO TOUCH, SORENESS AND ITCHING. ON 1-7-21, LUMP HAS DISAPPEARED, LESS SORENESS BUT REDNESS AND ITCHING REMAIN.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/05/2021,7.0,PUB,MULTIVITAMIN,NONE,NONE,,"CODEINE, LISINOPRIL, SEPTRA","['Erythema', 'Injection site mass', 'Pain', 'Pruritus', 'Skin warm']",1,MODERNA,ID 932349,IN,73.0,F,"Light headed at 10 min. after injection. than fine. Sore arm. Second day: Consistent headache, neck ache, pain in ears, blurry vision, nausea, numbness in lips, with labored breathing at times. This is the third day with no change. No treatment at this time. Still home waiting to see if I need to seek medical assistance.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,UNK,None,none,none,,Penicillin,"['Dizziness', 'Dyspnoea', 'Ear pain', 'Headache', 'Hypoaesthesia oral', 'Nausea', 'Neck pain', 'Pain in extremity', 'Vision blurred']",1,MODERNA,IM 932350,MA,50.0,F,"It's been 5 days since the vaccine. I felt symptoms at around 4 almost 5am. Diarrhea, vomiting, chills, heart racing.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/09/2021,4.0,WRK,METOPROLOL SUCC ER 50 MG TAB TABLET EXTENDED CYCLOBENZAPRINE 5 MG TABLET SERTRALINE HCL 50 MG TABLET FUROSEMIDE 20 MG TABLET SPIRONOLACTONE 25 MG TABLET METHOCARBAMOL 500 MG TABLET ENTRESTO 49 MG-51 MG TABLET,Congestive Heart Failure,Congestive Heart Failure,,None,"['Chills', 'Diarrhoea', 'Palpitations', 'Vomiting']",1,MODERNA,SYR 932351,IN,49.0,F,"Stomach cramping, diarrhea, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,Multivitamin,Na,Na,,Vicryl suture,"['Abdominal pain upper', 'Diarrhoea', 'Fatigue']",2,PFIZER\BIONTECH,IM 932352,IN,36.0,F,"Headache, chills, malaise, nausea, projectile vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,"Zoloft, vitamin C",None,None,,"Pcn, macrobid","['Chills', 'Headache', 'Malaise', 'Nausea', 'Vomiting projectile']",2,PFIZER\BIONTECH,IM 932353,IN,40.0,F,"Fever 100.3, extreme body aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/09/2021,8.0,PVT,None,None,None,,None,"['Fatigue', 'Pain', 'Pyrexia']",UNK,MODERNA, 932354,VA,37.0,F,"First vaccine received 12/18/2020. Diagnosed with COVID-19 12/28/20. Illness lasted 4 days. Returned to work 1/8/21. Second vaccine dose received 1/8/21 at 11:30am. Muscle aches, chills, and fever started at 19:30 on 1/8/21 and persisted throughout the night retning every 4 hours while alternating Tylenol 650mg every 4 hours and Ibuprofen 600 mg every 6 hours. Last fever was at 12:30pm on 1/9/21. Chills without fever at 4am on 1/10/21. Sweats and right arm localized redness and soreness persisted through 1/10/21 at the time of this report.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Lexapro, Wellbutrin, Chantix","First vaccine received on 12/18/20. No reaction. COVID 19 symptoms started 12/28/20, Positive test on 12/29/20. Symptoms lasted approximately 4 days. Returned to work on 1/8/21",Anxiety,,None,"['Chills', 'Erythema', 'Hyperhidrosis', 'Myalgia', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932355,MD,37.0,M,"On set delayed by 7 days. Redness, itchiness, warmth, tenderness, soreness, headache. Used naproxen 220mg OTC to treat headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/10/2021,8.0,PVT,None,None,None,,None,"['Erythema', 'Headache', 'Pain', 'Pruritus', 'Skin warm', 'Tenderness']",1,MODERNA,IM 932356,NC,46.0,F,"HAD NO PROBLEMS UNTIL 1 WEEK LATER. ON 1-7-21, PATIENT DEVELOPED LUMP AT INJECTION SITE. REDNESS, WARM TO TOUCH, SORENESS AND ITCHING.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,PUB,"MULTIVITAMIN, ZYRTEC, CLARITIN",NONE,NONE,,"LEVAQUIN, SEAFOOD, IODINE, IVP DYE","['Erythema', 'Injection site mass', 'Pain', 'Pruritus', 'Skin warm']",1,MODERNA,IM 932357,WI,35.0,F,"Severe headache, muscle aches, joint pain, especially prominent in upper back neck, nausea, chills, feeling hot, fever onset at 0200 1/10/2021 (100.8-100.9), I have taken Tylenol 650mg q 6 hrs. Ibuprofen 800mg once 1/9/21 at 2200.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,"Concerta 27mg, liotrythyronine 5mcg, synthroid 150mcg, nature made vitamin B complex with C, vitamin D 5000iu daily.",None,Hashimoto thyroiditis,,None,"['Arthralgia', 'Chills', 'Feeling hot', 'Headache', 'Myalgia', 'Nausea', 'Neck pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932358,CA,33.0,M,"12/30/20: Mild headache 12/31/20-1/2/21: Body aches, fatigue, chills, right arm pain, mild redness/swelling at injection site, mild itching around injection site 1/3/21-1/5/21: Fatigue 1/6/21: Symptoms resolve 1/7/21: Extreme itching around injection site, redness around injection site with multiple raised indurations, warm to touch, swelling, muscle ache, fatigue. Doctor seen and prescribed Doxycycline, Triamcinolone ointment, and Benadryl. Also, prescribed Prednisone in case reaction becomes more widespread. 1/8/21: Mild swelling/muscle pain to site, redness, itching persist, warm to touch 1/9/21: Swelling/muscle pain subsides, but redness and itching persist. Redness slowly spreading down arm. 1/10/21: Mild redness remains and continues to slowly spread down arm. Mild itching continues. Continuing to take Doxycycline and Benadryl PO, along with applying Triamcinolone acetonide ointment to affected area.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,"Multivitamin, Vitamin D3",,Asthma,,"Almonds, Walnuts, Azithromycin","['Chills', 'Erythema', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Pain in extremity']",1,MODERNA,IM 932360,OH,22.0,F,Lymph node swelled in right armpit on Wednesday night is still swollen. On Saturday 01/09 right arm swelled at injection site and had a hive. Benadryl helped with the swelling/hive at injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/06/2021,4.0,PVT,Montelukast 10mg po once daily Lo loestrin Fe po once daily,None,,,Augmentin,"['Injection site swelling', 'Injection site urticaria', 'Lymphadenopathy']",1,MODERNA,IM 932361,TX,72.0,F,"Rash starting on belly, and now all over body",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/07/2021,6.0,OTH,"Levothyroxine, omeprazole, ole start an, lipitor","High blood pressure, hypothyroidism, high cholesterol",Above,,None,['Rash'],1,MODERNA,SYR 932362,IN,25.0,F,"Within 24 hours if the initial vaccination I had redness, swelling, pain, and itching at the injection site that lasted fir about 3 days. Those symptoms completely resolved then on 1/5/2021, 1 week after my vaccination, I noticed itchy red bumps over the injection site. The next morning the injection site became even more swollen, red, itchy and painful despite taking Zyrtec. I saw my primary care provider on 1/7/2021 and she advised taking Benadryl and started me on Augmentin.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,OTH,"Vitamin c, zinc, vitamin d3",None,None,,Allergy to cefaclor with a hives reaction.,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling']",2,MODERNA,IM 932364,IN,38.0,F,Fever like symptom onset at 3:30pm on 01/08/2020 with chills. Temp at 99.8. Observed. Then temp at 4:30pm was at 100.8. Ibuprofen taken and sx resolved by 8pm the same day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Chills', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932365,,31.0,F,"Extreme fatigue/weakness, headache, chills, dyspnea, chest pain, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,,,,,"Cephalosporins, sulfa","['Asthenia', 'Chest pain', 'Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 932366,VA,38.0,F,"The patient presented with left eye peripheral visual loss, left upper and lower extremity and facial numbness sensation and weakness. This started 1 hour after receiving COVID-19 vaccine at her place of employment. Pt was brought to CRMC via EMS.",Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,"with past 24 hours prior to vxn pt reports taking: One a day women's vitamin, Benadryl, Allegra",none,"asthma, cold sores",,Pineapple,"['Angiogram cerebral', 'Arteriogram carotid', 'Chest X-ray', 'Computerised tomogram head', 'Facial paresis', 'Full blood count', 'Hypoaesthesia', 'International normalised ratio', 'Magnetic resonance imaging', 'Metabolic function test', 'Muscular weakness', 'Prothrombin time', 'Visual field defect']",1,PFIZER\BIONTECH,IM 932367,NJ,50.0,F,"Facial (cheek) numbness and swelling with slight face droop Swelling continued on 1/7/2021 On 1/8/2021, lip swelling and numbness and tongue numbness By 1/9/2021 4pm, swelling and numbness resolved but chills and muscle aches began",Not Reported,,Yes,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,None,None,None,,Erythromycin,"['Chills', 'Facial paralysis', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Lip swelling', 'Myalgia', 'Swelling face']",1,MODERNA,IM 932368,LA,47.0,F,"Fever of 101 starting at 9:35 am following the injection. Followed up by neck, should, arm pain beginning around 3:00 pm on the day of injection, and neck and shoulder pain continues today 1/10/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,Tylenol,None,None,,Pcn allergy,"['Arthralgia', 'Neck pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 932369,CA,59.0,M,"59 year male with history of HTN, became flushed and dizzy 7 minutes after vaccine. BP 170/100 P 78 O2 sat 97-99%. Denied SOB.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,HTN medications,HTN,HTN,,NKDA,"['Dizziness', 'Flushing']",UNK,PFIZER\BIONTECH,IM 932370,OH,23.0,F,Swollen lymph node in left armpit. Using ice and ibuprofen to help with over all swelling. After 5 days thought it was getting better but over night of day 5 to 6 unable to sleep due to the pain and ibuprofen not relieving anything only ice helped.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/05/2021,4.0,PHM,"Zyrtec, Yaz, vitamin D",,,,Kiwi,"['Lymphadenopathy', 'Sleep disorder']",1,PFIZER\BIONTECH,IM 932371,NC,49.0,F,"The patient received the vaccine in the left deltoid at 07:45 on 1/7/21. The patient reports that on 1/8/21 at around 0200, she was awoken with a sharp pain in her left arm followed by complete paralysis of her left hand for about 15 seconds. Did not re-occur. Did not seek treatment. Reported to Dr. and no further issues seen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,Daily multivitamin,Chronic Ulcerative Colitis,Chronic Ulcerative Colitis,,Sulfa,"['Pain in extremity', 'Paralysis', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 932372,WV,93.0,M,"Patient received the Moderna Vaccine 1/2/21 at his VA Clinic. He received the vaccine that morning and by the evening he was not feeling well. He developed cough, weakness and fever and now is unable to ambulate. He has since been hospitalized and has tested positive for COVID-19.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/02/2021,01/02/2021,0.0,PUB,"Amlodipine, NPH Insulin, Levothyroxine, Simvastatin",,,,No known allergies,"['Asthenia', 'Cough', 'Gait inability', 'Malaise', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 932373,IN,27.0,F,"Chills, moderate body aches that made it difficult to work, joint pain. Improved with ibuprofen/naproxen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,"Symbicort, Zyrtec, Flonase, omeprazole",No,"Asthma, GERD",,No,"['Arthralgia', 'Chills', 'Impaired work ability', 'Pain']",2,PFIZER\BIONTECH,IM 932403,FL,39.0,F,"Day 1-3 sore are w/ slight swelling. Took 2 Tylenol Day 1 and Day 2 plus iced my left arm both days. By Day 3 arm felt minimal sore, more back to normal. Reported all symptoms on V-safe. Day 4 completely normal. Day 7- red circle around injection site with slight itching, No medication. Communicated to medical director of rehab at my facility my delayed body response and reported on V-safe app. Day 8 exhausted slept 10 hours, and body chills. no medication taken. Updated my director of rehab of symptoms. Tried to report on V-safe however app does not allow for reporting past Day 7. Day 9 continued exhaustion, had to leave work early. Head felt in a fog, unable to focus. Day 10 all symptoms gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,PVT,"One-a-day women?s multi-vitamin; B12 500mcg; D3-K2 10,000; Magnesium 250mg",,,,Sulfa-face feels like a bad sun burn,"['Chills', 'Disturbance in attention', 'Fatigue', 'Feeling abnormal', 'Impaired work ability', 'Injection site erythema', 'Injection site pruritus', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 932404,NY,38.0,M,"Swelling, rash, and pruritis of multiple fingers of bilateral hands. Blisters on hands an feet, persistent now for 5 days. Using oral and topical benadryl and using topical corticosteroid with mild temporarily relief but subsequent reoccurrence of symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,PVT,none,none,none,,penicillian - rash certain detergents & emolients - rash,"['Blister', 'Peripheral swelling', 'Pruritus', 'Rash']",UNK,MODERNA, 932405,NV,50.0,F,"STRANGE FEELING IN THROAT AND CHEST THAT PROGRESSED TO CRUSHING CHEST PAIN. CHILLS, BODY ACHES, SOB, NAUSEA, RASH. I STILL HAVE SOB AND I DONT KNOW IF IT WILL BE TEMP OR PERMANENT.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,vitamin d mg fish oil valtrex,none,,,phenergen reglan compazine,"['Chest discomfort', 'Chest pain', 'Chills', 'Dyspnoea', 'Nausea', 'Oropharyngeal discomfort', 'Pain']",2,PFIZER\BIONTECH,IM 932406,NY,39.0,F,Hypotension and presyncope within 2 min of receiving the vaccine Tingling on face and both hands lasted for 2 hrs Following day- chills and abd cramping Day 3 -headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,None,None,None,,None,"['Abdominal pain', 'Chills', 'Headache', 'Hypotension', 'Immediate post-injection reaction', 'Paraesthesia', 'Presyncope']",2,PFIZER\BIONTECH,IM 932407,FL,34.0,F,"1/8/21. Second Pfizer dose. Immediately felt soreness in the arm radiating to the neck. Possible from technique vs actual vaccine 1807 - Neck pain, 3/10, left arm pain 3/10. Left cervical lymph node inflamed 2035 - ringing on right ear 2244 - dizziness 1/9/21. Injection site 1cm diameter bump. Pain in left arm, neck, shoulder 1156 - headache, sharp right parietal 3/10 1730 - pain 8/10 on left upper arm, radiating to lower arm, shoulder, neck. Improved to 4/10 after Advil 800mg once. 1/10/21. Woke up with pain in left arm 7/10. Injection site has induration of 4cm, reddened, warm, tender to touch. Pain improved after Advil 800mg and Tylenol 500mg",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"Armour Thyroid, Hydrochlorothiazide, Vitamin D, Prenatal vitamin, calcium/magnesium, probiotic",None,"Hypothyroidism, insulin resistance, obesity, chronic HTN",,"Peanuts, diphenhydramine","['Arthralgia', 'Dizziness', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site mass', 'Injection site pain', 'Injection site warmth', 'Lymphadenitis', 'Neck pain', 'Pain in extremity', 'Tinnitus']",2,PFIZER\BIONTECH,SYR 932408,OH,36.0,M,numb hand 24 hours after injection; arm pain; shoulder and neck pain; fever 101degrees,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Arthralgia', 'Hypoaesthesia', 'Neck pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932409,IN,53.0,F,Fever Chills Aches Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Lisinopril Hydrochlorothiazide Multivitamin Probiotics Vitamin D Lysine Krill oil,None,Just hypertension,,Some Shell fish Levaquin,"['Fatigue', 'Feeling cold', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932410,IN,45.0,F,"Woke up with chills and whole body aches almost 12 hrs. After injection. Chills lasted around 3 hrs. I then had extreme fatigue, nausea and headache for another 10hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,UNK,"Famotidine, zyrtec, B12",None,None,,Keflex,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 932411,NH,69.0,F,"I had mild reaction next day12/31/20, sore, some swelling and warm. 2 days later that was gone - on 1/8/2021 I woke up with a 2x2 rash, itchiness and warm , some swelling -",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/08/2021,9.0,WRK,flovent albuterol levothyroxine vit D calcium zyrtec,none,mild asthma hypothyroidism,,cefdiner clindamycin,"['Pain', 'Pain of skin', 'Pruritus', 'Rash', 'Swelling']",1,MODERNA,UN 932412,TN,58.0,F,"Redness, swelling, hardness, itching",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/26/2020,3.0,PVT,Night before vaccine and every evening after: Metoprolol 50mg Rosuvastatin 10mg One A Day Multivitamin Women's 50+ Morning of vaccine and PRN: Tylenol 500mg,None,Osteoarthritis,,NKDA,"['Erythema', 'Induration', 'Pruritus', 'Swelling']",1,MODERNA,IM 932413,NY,47.0,F,"Fever (101.9), myalgias, nausea, anorexia, headache x24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Multi-vitamin Iron tablets,None,None,,None,"['Decreased appetite', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932414,IN,43.0,F,"Dry cough, itchy throat, wheezing, SOB, heaviness in chest, headache. Resolved about two hours later after taking Benadryl and aleve.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Levothyroxine Docusate senna Fluticasone,,Hypothyroidism,,Penicillin,"['Chest discomfort', 'Cough', 'Dyspnoea', 'Headache', 'Throat irritation', 'Wheezing']",2,PFIZER\BIONTECH,SYR 932415,FL,35.0,F,"Entire body achy at midnight. Took total of 2 grams Tylenol, HA and tired x24 hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,Multivitamin Xyzol Vitamin D Probiotic,No,No,,Ancef Percocet,"['Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 932416,ID,28.0,F,"Patient was administered vaccine at an off hospital site. Patient acknowledged anxiety prior to vaccine administration. Following administration of vaccine, paatient reported that felt tingling in both hands, followed by lightheadedness, tunnel vision, dampening of hearing; was then moved from post vaccine observation area to an exam room. Patient complained that tongue felt swollen and numb and complained of difficult breathing Patient received Epinephrine 0.3mg SQ by the Physician Assitant; ambulance then requested. Stated that she felt relieved after receiving Epi pen, but heart racing and shakiness. Evaluated by paramedics; BP134/80 HR 85 spo2 100% and transported to local ED for suspected panic attack.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/10/2021,01/10/2021,0.0,UNK,,,,,,"['Dizziness', 'Dyspnoea', 'Hypoacusis', 'Hypoaesthesia oral', 'Palpitations', 'Panic attack', 'Paraesthesia', 'Swollen tongue', 'Tremor', 'Tunnel vision']",1,MODERNA,IM 932418,CA,25.0,F,"Extreme bone pain, worse on my right collarbone. Nausea starting 1/9/2021 morning around 6am. Active vomiting starting at 4pm and was vomiting every 10 minutes until about 10pm. Unable to keep any fluids down. Migraine since about two hours after vaccine administration. Woke up 1/10/2021 with body aches, headache, sore throat, nausea, injection site arm pain radiating up my neck.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,WRK,N/a,N/a,Asthma,,N/a,"['Bone pain', 'Headache', 'Injection site pain', 'Migraine', 'Nausea', 'Neck pain', 'Oropharyngeal pain', 'Pain', 'Vomiting']",1,MODERNA,IM 932419,MN,56.0,F,"Mild pain/soreness at injection site starting later the day of injection and next day. Approximately 2 pm the day after injection, began feeling overly hot and nauseated. That was followed by pressure type headache, muscle/bodyaches, and overall feeling of no energy progressing as the afternoon and evening continued. Spent that evening sleeping on/off. The following day spent in bed with continued headache, body/muscle aches, feeling overall drained/ no energy. Nausea improved some; was able to stomach some soup later in the day. So far today, feeling some improvement with bodyaches, but overall drained of energy. Headache has lightened some as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,"Thrive nutritional supplement, vit D capsule 5000 IU, turmeric curcumin 500 mg capsule , flaxseed oil/omega-3 capsule (1400 mg/700 mg), aller-tec 10 mg tablet, azelastine hcl nasal spray, estradiol cream 0.01%, tylenol 650 mg tabs",None,Indoor/ outdoor allergies,,"Augmentin, dogs/cats, outdoor allergans","['Asthenia', 'Feeling hot', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,SYR 932420,TN,44.0,F,"I am not sure if related on not. This event was 13 days after my COVID-19 1/2 immunization. Otherwise, I am a very healthy physician, normal BMI, I have also been tested 5-6 times negative for COVID. I do get exposed in my job, but wear proper PPE. Viral infection in FEB that was like COVID-19 sx, I did AB test as soon as it was available, and negative. ---The Event: Monday morning (1/4/21), after getting out of shower, I was talking to my husband (who is MD)and started having BROCA's aphasia sx (could not get words out coherently), then fell into bed and started right wrist and right foot posturing. This lasted 10 min. I have non-memory of it, but my MD husband witnessed it. After 10 minutes, I was back to normal, except shaky and some word finding difficulties. After 30 min, totally back to normal.",Not Reported,,Yes,Not Reported,,Not Reported,Y,12/22/2020,01/04/2021,13.0,WRK,"xyzal 10mg 1/day, Sudafed 12 hour XR 1 po qAM, Nasonex nasal spray 2 puffs q AM, Emgality 120mg once a month (last 12/17), carisoprodol 350mg q 6 hours, prn; norco q 6 hours, prn; zanaflex 8 mg qhs, prn. DID take a diflucan the prior nigh",none.,"Chronic migraines, usually without AURA, 2 times in life with aura, Transformed migraine into chronic daily headache after DEPO shot at 23 yo. Chronic neck pain, mild bulging disk, DDD. +ANA, non-specific. Pattern has been different 2 times (3 yrs ago, showed positive for lupus titers, but no lupus sx, so rheumatologist did not feel like I had lupus).",,"PCN (rash), Septra (rash).","['Angiogram cerebral normal', 'Aphasia', 'Arteriogram carotid normal', 'Coagulation test', 'Echocardiogram normal', 'Electrocardiogram ambulatory', 'Magnetic resonance imaging brain normal', 'Memory impairment', 'Posturing', 'Scan with contrast normal', 'Tremor']",1,PFIZER\BIONTECH,IM 932421,IL,71.0,M,"2-3 days after the shot , blurred vision, slurred speak, couldn't smile, it shifted up to the left, couldn't chew food, tired, sun sensitivity, tearing of eye. Stated Bells Palsey.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/19/2020,2.0,PVT,"Lopressor, Janumet, baby aspirin, omeprazole, Synthroid, Lipitor, amlodipine, lisinopril, Sertraline. Vitamin D, zinc.",no,"Diabetes, Hypertension, mitral valval prolapse.",,,"[""Bell's palsy"", 'Computerised tomogram', 'Dysarthria', 'Facial paralysis', 'Lacrimation increased', 'Mastication disorder', 'Photosensitivity reaction', 'Vision blurred']",1,PFIZER\BIONTECH,SYR 932422,CA,31.0,F,"Pytariasis rosea, generalized red splotches around trunk, starting to spread down limbs and neck. Not itchy, it painful,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/26/2020,2.0,PVT,"Wellbutrin, birth control",,,,"Sulfa drugs (hives), mango (rash)",['Pityriasis rosea'],1,PFIZER\BIONTECH,IM 932423,IN,53.0,F,Itching and mild swelling of rt lower lip which started within 5-6 mts after the vaccine. Itching stopped after 1-2 hrs but swelling got better after 24 hrs . Did not progress to any other symptoms. Swelling of the lip is still intermittent.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Prednisone,No,"SLE, adrenal insufficiency",Influenza probable neurological symptoms,"Contrast dye, pyrazinamide, powdered gloves, latex?","['Lip pruritus', 'Lip swelling']",UNK,MODERNA,IM 932424,GA,51.0,M,"Fever close to 102, rigors, aches, fatigue, overwhelming weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,WRK,None,None,None,,Penicillin,"['Asthenia', 'Chills', 'Fatigue', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932425,NY,67.0,F,"Nausea, unable to eat or drink, vomiting, achy, stomach ache. Extreme fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,,None,"HOCM, osteoporosis",,"Reclast, radioactive dye","['Abdominal pain upper', 'Fatigue', 'Feeding disorder', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,IM 932426,CT,32.0,F,Within 10 minutes I've receiving vaccine I became dizzy flushed from the chest to the throat and face throat felt tight for a brief moment which passed quickly dizziness came back approximately one hour later then starting 2 days after injection I had diarrhea 3 days after injection that I had chills and nausea. days 4-6 after injection I had severe headache nausea chills muscle aches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Vitamin C,Allergic reaction to Lorena or levaquin,,,"Bees, mirena, levaquin","['Chills', 'Diarrhoea', 'Dizziness', 'Flushing', 'Headache', 'Myalgia', 'Nausea', 'SARS-CoV-2 test negative', 'Throat tightness']",1,MODERNA,IM 932428,OR,36.0,F,"Fever, body aches, joint land bone pain, headache. Improved with antipyretics and sleep. This occurred in the evening, so I?m not sure how long symptoms would have lasted as I went to sleep. I woke up feeling just slight tired and sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,None,None,None,,None,"['Arthralgia', 'Bone pain', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932429,IN,56.0,M,"I had fever, chills, arm pain and swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2020,,PVT,0,0,0,,0,"['Chills', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932430,TX,31.0,M,Fever and body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,UNK,Concerts 54mg,No,No,,Sulfa,"['Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 932431,CA,61.0,F,itchiness and 2 inch red welt at injection site noticed 8 days after vaccine received applied benadryl cream for 2 days and it is fading to lighter pink,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/08/2021,9.0,PVT,centrum silver multi-vitamin fish oil niacin calcium + D3,none,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site urticaria']",1,MODERNA,IM 932432,TX,71.0,M,22nd day temp 102 headache myalgias nasal congestion resolved the 3rd day,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,rytary,,parkinson,,0,"['Body temperature increased', 'Headache', 'Myalgia', 'Nasal congestion']",2,PFIZER\BIONTECH,IM 932433,VT,30.0,F,Bloody noses,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/10/2021,1.0,UNK,Levothyroxine,"Hypothyroidism, IIh",,,,['Epistaxis'],1,MODERNA, 932434,TX,38.0,M,"Pretty bad arm pain immediately after shot. Still continuing today 48 hours later. Yesterday (24 hours after) felt generally bad, sore muscles.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PHM,"Prilosec 20mg, vitamin d 2000iu",None,None,,None,"['Feeling abnormal', 'Immediate post-injection reaction', 'Myalgia', 'Pain in extremity']",1,MODERNA,SYR 932435,IN,30.0,F,"Sore and swollen arm at injection site, headache, fatigue, fever, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,Lamictal,,,,,"['Chills', 'Fatigue', 'Headache', 'Injection site joint swelling', 'Injection site pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 932436,IL,22.0,F,"fever, chills, aches, nausea, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,TriSprintec,,,,,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932437,CO,37.0,F,"Large amount of swelling in axillary starting about 36 hours after vaccine. Swelling is soft, very little pain and about the size of a softball.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2020,01/09/2020,1.0,PVT,Tylenol and ibuprofen,Cold (tested negative for covid) on December 16,None,,Nonw,"['Axillary pain', 'Lymphadenopathy', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 932438,OH,64.0,F,"Initially after getting the vaccine I had mild to moderate soreness in my arm for about 1-2 days which then subsided. Then on Jan.7 I began to have itching at the injection site and a 3x4 inch area of redness. I applied some OTC 1% hydrocortisone cream which did lessen the itching but redness persisted. Today, Jan.10 the redness measures approximately 3 1/2 x 4 1/2 inches, itching is present at times and area is warm to the touch. I have no fever and arm feels only slightly tender right where needle was inserted.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/07/2021,9.0,PUB,"Methimazole 3.75mg daily, VitaminD3 2000iu daily, Ibuprofen 400mg p.r.n., Kroger brand Migraine formula 1 tab p.r.n.",None,Graves disease,,None,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 932439,NY,35.0,F,*I have had a very hard time staying warm since the shot the *all of Friday I was nausiouse and tiered (the day after the shot) * when I woke the next morning my face chin area itched over the past 2 days my face has broken out it itches and is spreading I have tried dubbling my allergy pill taking Benadryl washing my face with Dawn dish soap its 1130am Sunday the 10th jan the rash is all the way up below my upper cheek bones,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/08/2021,7.0,PVT,Isentress. Truvada. An all day allergy pill cetirizine 10mg Ibuprofen,,Hiv positive. Undetectable for 5+ years,,Strawberries,"['Fatigue', 'Nasopharyngitis', 'Nausea', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH,SYR 932440,IL,42.0,F,"1/7/2021 21:30 Headache 1/8/2021 0130 until 2330, Fever, body pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Levothyroxine, Ubrelvy",None,None,,None,"['Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 932441,TX,31.0,F,"Woke in middle of night (2am approx. 12hrs post vax) with palpitations, HR 120s, SOB, fever 100.8, sweats, chills, body/joint aches. Palpitations and SOB persisted for approx 4hrs, off and on. Fever 100.2 and body aches persisted until approx. 5pm the day after 2nd vax (approx 27hrs).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,WRK,"Vitamin D3, Calcium, Lorena birth control",,,,Shellfish,"['Chills', 'Dyspnoea', 'Hyperhidrosis', 'Pain', 'Palpitations', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932442,PA,41.0,F,Within one minute of receiving the vaccine patient became very shaky and heated. Felt like she was going to pass out. I gave the patient one 25mg Benadryl at 11:18 and orange juice. Within a few minutes of taking the Benadryl and also being able to take in air outside the mask her symptoms improved and felt herself.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,Zoloft 200 mg Tylenol 1 gm,,,,Topical Iodine Vicodin-Intolerance,"['Dizziness', 'Feeling hot', 'Immediate post-injection reaction', 'Tremor']",1,PFIZER\BIONTECH, 932443,VA,44.0,F,My arm felt a bit swollen on day 10. By day 11 I have a reddened area around the site. I took 50mg of Benadryl.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/09/2021,9.0,PVT,None,None,Kidney stones,2011 I broke out in a couple hives after a flu shot. It was found to be do to a preservative in the vaccine that begins with a ,Levaquin,"['Injection site erythema', 'Peripheral swelling']",1,MODERNA,IM 932444,IN,31.0,F,"Chills, fever of 103, migraine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,Gianvi birth control,Na,Na,,Na,"['Chills', 'Migraine', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932445,AL,59.0,M,Severe hypertension with BP 185/105 and new onset atrial fibrillation,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,"Benadryl, apple cider vinegar, aspirin, vitamin d3",none,"gout, arthritis, diverticulitis, gerd, hiatal hernia,",,amoxicillin,"['Atrial fibrillation', 'Blood pressure abnormal', 'Heart rate abnormal', 'Hypertension']",1,PFIZER\BIONTECH,IM 932446,TX,49.0,F,DAY ONE - FEVER >101.1F,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,NONE,NONE,NONE,,NONE,['Pyrexia'],2,PFIZER\BIONTECH,IM 932447,PA,46.0,F,"Patient noted side of tongue feeling ""funny"" in the morning. Tongue began swelling affecting airway. Some facial swelling. Went to urgent care . Administered injectable steroid and epinephrine and sent via ambulance to ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,PVT,none,no,asthmatic,,animal dander allergies,"['Obstructive airways disorder', 'Paraesthesia oral', 'Swelling face', 'Swollen tongue']",1,MODERNA,IM 932448,IN,46.0,M,"Headache, full body aches, fatigue, cold sweats/chills, increased urine output and frequency. Treated with rest, acetaminophen for pain, fluid replenishment.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Cold sweat', 'Headache', 'Pain', 'Pollakiuria', 'Urine output increased']",2,PFIZER\BIONTECH,SYR 932449,NH,41.0,F,Cellulitis at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/05/2021,3.0,OTH,"Advair, Allegra, Flonase, Singular, Lo Loestrin Fe",None,Asthma and seasonal allergies,,"Arithromyacin, clindamycin, aspirin",['Injection site cellulitis'],UNK,MODERNA,IM 932450,IN,42.0,F,"Morning after the 2nd dose of vaccine I developed chills, body aches, malaise/fatigue. It lasted approximately 5-6 hours and then started to improve.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Bystolic Adderall xr,,Inappropriate sinus tachycardia Back pain ADHD,,,"['Chills', 'Fatigue', 'Malaise', 'Pain']",2,PFIZER\BIONTECH,IM 932451,IN,41.0,F,Fatigue. Severe axillary lad and supraclavicular lad. Myalgia. Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,UNK,Ocp. Lamictal zyrtec lexapro,Svt. Ocd. Mdd. Htn. Osa.,See above,,Fish,"['Fatigue', 'Lymphadenopathy', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 932452,,34.0,F,Delayed injection site reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/06/2021,9.0,PVT,,,,,,['Injection site reaction'],1,MODERNA,IM 932453,TX,68.0,M,"Achy , tired, low grade fever, soreness in shot site",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,Atorvastatin 80 mg Isosorbide Mono ET 60mg Amlodipine 5mg Dexilant DR 60mg Aspirin 81 mg Centrum Silver multivitamin Glucosamine 1500mg Chondroitin 1200 mg Fish Oil 1400mg Omega 3 980mg Zinc 50 mg Iron 65 mg,,Heart Artery blockage. 1 Stent,,Sulpha,"['Fatigue', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,SYR 932454,OH,24.0,F,"Fever, chills, and myalgia not controlled by 600 mg ibuprofen q6h developing around 11 hours after vaccination and peaking around 15 hours after vaccination, resolving overnight without need for ibuprofen upon awakening.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,"Valtrex, Mirena",None,None,,Amoxicillin,"['Chills', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 932455,IL,57.0,F,"Moderna COVID-19 Vaccine EUA. On Friday 1/8/2020 I noticed an itching, soreness, increased warmth at site and three bumps on left upper arm. Took benadryl, applied hydrocortisone cream, and ice packs to site. The next day the redness had increased, itching and soreness, and increased warmth at site remained. Continued to use same treatment as day before. Symptoms began to resolve on Sunday 1/10/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/08/2021,9.0,PVT,"Balsalazide, spironolactone, lansoprazole, levoxyl, metoprolol, metformin. vitamin d, calcium, mvi, fish oil, metamucil",none,"hypothyroidism, hypertension, GERD, gastritis, ileitis, type 2 diabetes",,none,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,MODERNA,IM 932456,,64.0,F,Delayed injection site reaction,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/06/2021,9.0,PVT,,,,,,['Injection site reaction'],1,MODERNA,IM 932457,NY,31.0,F,flushed and warm skin,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,,,,,multiple food allergies,"['Flushing', 'Skin warm']",1,MODERNA,IM 932458,NJ,52.0,F,"One week after COVID vaccine, I have developed a rash at site of injection. The rash is currently about 3 inches wide and 4 inches long. It started on Thursday 1/7 as a few rash spots and now is a uniform red patch which has spread slightly (I drew a mark around border of rash to track this).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,ibuprofin and naproxin (for a few days for arm soreness after COVID vaccine),no,no,,"sulfa, bee stings","['Injection site erythema', 'Injection site rash']",1,MODERNA,IM 932459,FL,52.0,M,"Tingling and numbness in my left hand, mainly the 4th and 5ths fingers. This occurred about 15 min after the injection. It has persisted until today (01/10/2021). Tingling now is mostly in 5th finger. It is not present all the time. It is worse when I extend my arm at the shoulder.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,WRK,"Sertraline, Bupropion, Omeprazole",None,None,,None,"['Hypoaesthesia', 'Pain', 'Paraesthesia']",1,MODERNA,IM 932460,PA,28.0,F,"On day 0 of receiving the vaccine I experienced arm pain at the injection site and extreme fatigue. I went to sleep at 9pm and awoke at 1am with chills. My temperature was 99.5. Throughout day 1 after the injection, I experienced more fatigue, arm pain, chills, headache, and overall body aches. I did not take any medication to relieve symptoms. On day 2 I awoke with just a minor headache. Arm pain improved significantly, but is still present.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Tri-Sprintec (oral contraceptive), Spirinolactone, Tretinoin, Clindamycin lotion",None,None,,Penicillin,"['Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pain', 'Pain in extremity']",1,MODERNA,IM 932461,SD,29.0,F,"Flushed face, light headedness, shortness of breath, and chest tightness 20 minutes after vaccination. Needed albuterol inhaler and benadryl to stop reaction. Redness swelling at injection site up to 1/2 dollar in size now, still increasing in size. Even after 3 days since shot",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Iron Clarita singular,,Asthma,"29 year old, adverse reaction to 1st covid shot, Pfizer covid. 12/18/2020. Identical symptoms but more severe. Needed steroid in",Erythromycin,"['Chest discomfort', 'Dizziness', 'Dyspnoea', 'Flushing', 'Injection site erythema', 'Injection site swelling']",2,PFIZER\BIONTECH,IM 932462,DC,22.0,F,"On 1/6/21, I noticed a hard, red spot on my arm where I got the COVID vaccine. This red spot got bigger over the next 2 days and reached a maximum length of 3 inches and maximum width of 2.75 inches. It was warm to the touch. On 1/8 and 1/9 I also had a headache and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,OTH,Amitriptyline Magnesium malate Rizatriptan,None,Migraines Mild PCOS,,None,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site warmth']",1,MODERNA,IM 932463,,39.0,F,Delayed injection site reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/07/2021,9.0,PVT,,,,,,['Injection site reaction'],1,MODERNA,IM 932464,IL,63.0,F,"Patient woke up Saturday am and right foot felt like it was sprained, painful at ankle joint, slightly red. Sunday morning, she could not put any weight on right foot, more red/all toes red (except one), redness is traveling down right big toe, right foot appears slightly swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Arthralgia', 'Erythema', 'Pain in extremity', 'Peripheral swelling']",1,PFIZER\BIONTECH,IM 932465,IN,60.0,F,"4""x5"" large red raised painful bump which was hot to the touch flu like symptoms-lethargy, sore throat, stomach upset The symptoms increased in intensity over three days, beginning to see decrease on fourth Treated with ice and Tylenol. Antihistamin on first day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,70 mg. Aimovig Oxaprozin 600 mg cyproheptadin 4 mg Sertraline 100 mg Clonazepam 1 mg,,"Chronic Migraine, Depression/anxiety disorder",,"Garlic, Neomiacin, Bee sting","['Abdominal discomfort', 'Influenza like illness', 'Lethargy', 'Oropharyngeal pain', 'Rash erythematous', 'Skin warm', 'Swelling']",UNK,MODERNA,SYR 932466,CA,50.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Fever, Chills, Joint Pain, Muscle Pain, Headache Symptoms lasted for 36 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,levothyroxine,none,hypothyroidism,,no,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932467,WV,45.0,F,"Following day 12/24 couldn't drive with arm. 12/27, worst headache of her life with nausea and vomiting. Worse than her concussion. Lasting about 8hrs. Took oxycodone and threw it up. Went to sleep. Started getting whelps/hives. Worsened al through new years. Took Benadryl. Hives around the eyes. 1/1 started bruising on leg and thigh. 1/5 started feeling better. Rash and bruising is gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,Vitamin D3 5000u.,no,concussion 4years ago causing headaches. Resolved.,,"shell fish, peanuts, walnuts, wheat, cabbage.","['Contusion', 'Headache', 'Nausea', 'Urticaria', 'Vomiting']",1,MODERNA,SYR 932468,,30.0,F,Delayed injection site reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/07/2021,10.0,PVT,,,,,,"['Injection site reaction', 'Skin reaction']",1,MODERNA,IM 932469,TX,53.0,F,"The injection site bled after the injection (about 3:00PM). A bruise formed on my arm at the injection site by the evening, it was larger in the morning. I noticed a bit of redness and swelling about 30 hours post injection. I woke this morning with darker bruising and larger red swollen, and slightly warm reddening on the arm next to the bruising . There is tenderness but I can move my arm and aside from fatigue I feel fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Corgard, Amlodipine besylate, Ritual essential multivitamin with omega fish oil, vitamin C, Dermal Repair vitamin complex with vitamin A, Thiamin, Riboflavin, Vitamin B6, Folate, Biotin, Pantothenic acid, Sawmill, MSM, Hyaluronic acid",none,"HTN, Calculae Diverticulum in the kidney, AV node ablation in 1988",,"Narcotic sensitivity (vomiting and dizziness), Hydrochlorathiazide (rash)","['Fatigue', 'Injection site bruising', 'Injection site erythema', 'Injection site haemorrhage', 'Injection site swelling', 'Tenderness']",1,MODERNA,IM 932470,IN,64.0,F,"Fever, headache, lethargy for 36 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Vitamin D3, Centrum vitamin",None,Osteoporosis,,Sulfa,"['Headache', 'Lethargy', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932471,,41.0,F,Delayed injection site reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/07/2021,8.0,PVT,,,,,,"['Injection site reaction', 'Skin reaction']",1,MODERNA,IM 932472,NJ,20.0,F,Headaches started a few hours after the vaccine and then fever/chills/sweats also started around that time. It?s been two days since the vaccine and I do not feel headaches anymore but I am still sweating and I have a mild fever.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,SCH,"Birth control, vitamin D supplements and cranberry supplements",None,None,,None,"['Chills', 'Headache', 'Hyperhidrosis', 'Pyrexia']",1,MODERNA,SYR 932473,IN,44.0,F,"Bone and joint pain in the arm the vaccine was received in. Applied heating pad, kept elevated with a pillow, took ibuprofen for pain. Symptoms lasted about 16 hours at a pain scale of 8/10. Today it?s more tolerable at about a 4/10",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,"Nexium, melatonin, ibuprofen",None,None,,None,"['Arthralgia', 'Bone pain']",2,PFIZER\BIONTECH,IM 932474,NY,32.0,M,redness at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,,,,,NKA,['Injection site erythema'],1,MODERNA,IM 932475,FL,65.0,F,Fatigue muscle aches weakness nauseous,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,OTH,"Metformin, Pravastatin prazolam ozempic lisinopril, alprazolam, carisoprodol",Morepha scalp,Diabetic,,Sulfur,"['Asthenia', 'Fatigue', 'Myalgia', 'Nausea']",1,MODERNA, 932476,IN,47.0,F,"Sore arm, achy muscles fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/09/2021,8.0,OTH,"Allegra, Breo, Aimovig, Nasonex, Amitriptyline, Celexa",,Allergies Asthma,,Amoxicillin,"['Fatigue', 'Myalgia', 'Pain in extremity']",UNK,MODERNA,SYR 932477,TX,67.0,F,Initial soreness at injection site gradually subsided over the course of 1 week. On day 11 pain at injection site woke me during the night. There is an approximately 2.5 inch raised area slightly warmer than surrounding area and very tender to touch. Some itching at the site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/10/2021,11.0,PVT,"Montelukast, metoprolol, atorvastatin, estradiol, symbacort, escitalopram, levocitrazine, azelastineflonase, zolpidem, Ativan, vitamins: B12, biotin, iron with vitamin C, D3, super B complex, barriatric multivitamin, calcium, Saline nasal",None,"Asthma, environmental allergies, osteoarthritis, depression",,"Floxin, Inderal, pregabalin, adhesive, aspercream, some scented lotions and creams","['Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Sleep disorder']",1,MODERNA,SC 932478,,47.0,F,Delayed injection site reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/06/2021,6.0,PVT,,,,,,"['Injection site reaction', 'Skin reaction']",1,MODERNA,IM 932479,IN,40.0,M,"Approximately 20 hours after I received the second vaccine dose, I developed a fever of 102 F. This was associated with other moderate-to-severe flu-like symptoms including chills, myalgias, and headache. Within 3 hours, the fever decreased to 99-100 F and remained between 98-99 F throughout the rest of the day. The headache and myalgias persisted, but by the following day (today), nearly all symptoms had resolved. No GI symptoms were experienced.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,None,None,Hypertension,,None,"['Chills', 'Headache', 'Influenza like illness', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932480,MN,69.0,M,"pt received Moderna vaccine. next day he had high fevers up to 103, confusion. admitted to hospital. infectious work up negative. improved off antibiotics.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/05/2021,01/06/2021,1.0,SEN,,Covid 19 infection diagnosed 5weeks prior,"COPD, CAD, HTN, demenita",,none,"['Blood test normal', 'Confusional state', 'Pyrexia']",UNK,MODERNA, 932482,IN,38.0,F,"Body and extremities started tingling and felt very heavy, heart felt like it was racing, throat felt like it was slightly swollen, chills, head felt foggy, instant fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,"Omeprazole, synthroid, Flonase, naproxen, elderberry gummie, Apple cider gummie, probiotic, cbd","Had a headache for the last month intermittently, but dull to moderate","Reflux, hypothyroidism from treated Graves? disease, IBS, asthmatics",,"Sulfa, insect stings/bites","['Chest discomfort', 'Chills', 'Discomfort', 'Fatigue', 'Feeling abnormal', 'Palpitations', 'Paraesthesia', 'Pharyngeal swelling']",1,PFIZER\BIONTECH,IM 932483,IN,44.0,F,"I woke up the next morning 1/9/21 about 6am after receiving the vaccine the evening before, my face and mainly my eye lids were extremely swollen. Later in the day, ~noon I spiked a fever of 102.4. I had overall body aches and chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Levothyroxine 50mcg Omeprazole 40mg,Covid-19,Hoshimoto?s thyroiditis,,,"['Chills', 'Eye swelling', 'Pain', 'Pyrexia', 'Swelling face']",2,PFIZER\BIONTECH,IM 932484,,41.0,F,Delayed injection site reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/08/2021,9.0,PVT,,,,,,"['Injection site reaction', 'Skin reaction']",1,MODERNA,IM 932485,IN,28.0,M,"Fever, peaking at 99.8 but averaging 99.5, for 36 hours. General malaise, fatigue, and soreness for 36 hours. Pain at injection site, moreso than 1st injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,"Cymbalta, Protonix",None,"Anxiety, Depression, Stomach Ulcers",,None,"['Fatigue', 'Injection site pain', 'Malaise', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932486,,24.0,F,Delayed injection site reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/07/2021,9.0,PVT,,,,,,['Injection site reaction'],1,MODERNA,IM 932487,TN,55.0,F,"Chills/Fever (103 at the highest) This started around 10:00pm, so I took 600 mg of ibuprofen and the chills continued for 3 hours. Muscle aches and right arm stiffness occurred and remained for a couple days. The second day, my fever was hovering around 101 most of the day. I took ibuprofen and the fever let up, but returned in the night and persist today (day 3). My fever is right at 100 today.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,Amlodipine 5mg Clonidine patch 0.1mg Multivitamin (Alive) D3 Zyrtec Aspirin 80 mg,None,,"DTP in left arm; polio drops under tongue;MMR in right arm When the third vaccination was given (DTP), I blacked out. My arm swe",Erythromycin Tetnus Gluten sensitive Shell fish,"['Chills', 'Musculoskeletal stiffness', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 932488,,55.0,F,Delayed injection site reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/06/2021,9.0,PVT,,,,,,"['Injection site reaction', 'Skin reaction']",1,MODERNA,IM 932489,,42.0,F,"This is another reaction I experienced. My left arm started to be sore again 8 days after vaccination, on 1/7/21 (I originally had sore arm on left the first 3 days of vaccination but then it was recovered). I also feel there is some weakness on my left arm as well. I wonder if this is a delayed reaction and if it would be permanent? I previously filed an report on early adverse events-left arm soreness within an hour of vaccination, then spread across shoulder, in the middle of night, I woke up with whole body muscle ache that lasted till next morning. The next day of vaccination, I was tired , yawning frequently and very sleepy. I slept for 11 hours on the second night of vaccination which was unusual for me. The sore arm disappeared after about 3 days. But 8 days later it occurs again with some weakness on upper left arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/07/2021,8.0,UNK,hydroxychloroquine,,SLE,,cephalaxin (keflex),"['Arthralgia', 'Fatigue', 'Muscular weakness', 'Pain', 'Pain in extremity', 'Sleep disorder', 'Somnolence', 'Yawning']",1,MODERNA,IM 932490,PR,55.0,F,"Swenllen area, fecer in area, itchy and little pain. Started to feel symptoms during afternoon. My doctor prescribed predisone 20 mg one daily for 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/08/2021,9.0,OTH,None,None,None,,Penicilin,"['Pain', 'Pruritus', 'Pyrexia', 'Swelling']",1,MODERNA,IM 932491,TX,55.0,F,"Cough, body aches, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Lexapro, immunity complex from Shaklee, bone complex from Shaklee, vitaminD",Cedar allergies,"IBS, osteoporosis",Flu vaccine many years ago,Latex,"['Cough', 'Headache', 'Pain']",1,PFIZER\BIONTECH,IM 932492,IL,34.0,F,"Fever 102, severe migraine, dizziness, stiff neck, enlarged axillary lymph nodes, chills, body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Synthroid, priztiq,plaquenil, magnesium",None,"Cancer in remission, history of keytruda immunotherapy, migraines",,None,"['Chills', 'Dizziness', 'Lymphadenopathy', 'Migraine', 'Musculoskeletal stiffness', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932493,CA,66.0,M,Patient tested negative for Covid for 9 months. He was asked if he wanted a Covid Vaccine. Patient recieved the vaccine on Tuesday . On Saturday patient was moved without being told why to the Covid unit. Patient has been at this facility for more than 5 years. He is in good standing and pays his bill each month. He is current.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/09/2021,8.0,SEN,None,Rash on back arms and legs.,Wheelchair user.,,None,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,SYR 932494,OH,41.0,F,"Scratchy throat, pressure & tightness in chest, headache, malaise, nausea, cramping(gastrointestinal pain), diarrhea, migraine, extreme exhaustion, fatigue, muscle and joint pains, cold flashes, extreme weakness, off balance, feeling faint",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,PVT,"Ambien, Wellbutrin, omeprozol, calcium/magnesium",None,None,,Cipro= flu like symptoms,"['Arthralgia', 'Asthenia', 'Balance disorder', 'Chest discomfort', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Feeling cold', 'Gastrointestinal pain', 'Headache', 'Malaise', 'Migraine', 'Muscle spasms', 'Myalgia', 'Nausea', 'Throat irritation']",1,MODERNA,SYR 932495,TX,68.0,F,"Rash developed at site of injection 1 week afterwards. It started as 4 small red dots, then grew & coalesced to a solid 4.5 cm diameter red raised area by the following morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/09/2021,7.0,PVT,"tylenol, pepcid, cbd gel tabs, multivitamins",none,"mild asthma Recovering from wrist fracture11/27/2020, in opposite arm from vaccination",,"PCN, cephalosporins, sulfa","['Injection site erythema', 'Injection site rash', 'Injection site swelling']",UNK,MODERNA,IM 932496,IN,53.0,F,"Multiple episodes of dizziness, coming and going. Arm hurt upon movement starting shortly after midnight after received and still hurting, joint pain and headache began early AM 01/09/21. All have ended except pain at injection site and joints still achy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"Levothyroxine Hydroxyzine Pam Melatonin Prilosec Quetiapine Trintellix Atorvastatin Bupropion hcl Lisinopril Amlodipine, Low dose Aspirin",None,Hypothyroidism Depression Hypertension,,Augmentin,"['Arthralgia', 'Dizziness', 'Headache', 'Injection site pain', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 932497,,57.0,F,Delayed injection site reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/07/2021,8.0,PVT,,,,,,"['Injection site reaction', 'Skin reaction']",1,MODERNA,IM 932498,ID,22.0,M,"Headache and arm pain began at 11:30pm. Then I woke up at 2:30am with chills, fatigue, nausea, body aches, and congestion",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,None,None,None,,Peanuts,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Respiratory tract congestion']",2,PFIZER\BIONTECH,IM 932499,MN,50.0,M,"Swollen arm pit, puffy, achy, not red or warm. Noticed about 36hrs after that had ache under arm pit. Visually swollen. Took naproxen helped with pain but not swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,PVT,"Escitalopram, melatonin, NSAIDs, APAP",None,None,,NKA,"['Axillary pain', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 932500,VT,54.0,M,"Red swollen, burning and itchy eyes 10 hours after dose. Benadryl 50 mg taken. Eye swelling, redness, burning, itchy persisting into the next day. Another dose of medicine taken. Low grade fever, headache, fattier Tylenol 1000 mg taken",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PVT,Flonase,None,Arthritis,,Amoxicillin Rash,"['Eye irritation', 'Eye pruritus', 'Eye swelling', 'Headache', 'Ocular hyperaemia', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 932501,NV,30.0,F,Cellulitis outcome determined at urgent care- redness swelling itchiness and warm to touch,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,PUB,None,None,None,,None,"['Cellulitis', 'Erythema', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,IM 932502,IL,52.0,M,"Woke in pain and shivering body temp 89.4 axillary, oral, and non-contact forehead",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,None,Borderline DN HTN,None,,Avelox,"['Body temperature increased', 'Chills', 'Pain']",2,PFIZER\BIONTECH,IM 932503,OH,21.0,F,I have a rash at the site of vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/09/2021,12.0,UNK,"Pantoprazole, Montelukast, Tizanidine Hydrochloride",,,,Augmentin,['Vaccination site rash'],UNK,MODERNA,SYR 932504,TN,51.0,F,"Tachycardia almost immediately after injection 100-110s. Slight tightness of chest, but I was trying not to panic. Tachycardia increased to 130s for 2 minutes then came down to 100s, BP 140/86, a little nausea and slight headache. Better at 4:45 thought I was good to leave. Then BP spiked to 180/110s, HR 136, transported to ER for monitoring. Tachycardia and HTN would continue to cycling elevate over next 2hours before being discharged with HR of 100s and BP 150/86",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,Olmesartan 40mg Amlodipine 2.5mg Vit D3 5000U Multi vitamin Co Q 10 100mg,,Hypertension NSR tachycardia,,Sulfa,"['Blood pressure increased', 'Chest discomfort', 'Electrocardiogram normal', 'Headache', 'Hypertension', 'Immediate post-injection reaction', 'Nausea', 'Tachycardia', 'Troponin normal']",1,PFIZER\BIONTECH,IM 932505,IN,66.0,M,"Vomiting (1/9) in the evening; mild headache, body aches, fatigue (1/10)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Levothyroxine (150mcg); montelukast (10mg); lisinopril (10mg); naproxen (220mg); zinc,None,None,,None,"['Fatigue', 'Headache', 'Pain', 'Vomiting']",2,PFIZER\BIONTECH,SYR 932506,AR,29.0,F,"Rapid heart rate, fever, nausea and cold sweats",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,SEN,None,None,None,,None,"['Cold sweat', 'Heart rate increased', 'Nausea', 'Pyrexia']",UNK,MODERNA, 932508,CA,47.0,M,Employee reported inflamed lymp node on the right axilla the following day he had the vaccine and did not disappear for more than a week. Will seek advise from his primary care provider for further evaluation,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,WRK,,,,,,['Lymphadenopathy'],1,MODERNA,IM 932509,CT,33.0,F,"Developed erythematous and pruritic raised rash at injection site on Day 8 that expanded until Day 13 (almost resembled erythema migrans prior to resolution). Rash resolved on Day 14. Applied topical prescription steroids on Day 9, which did not significantly improve rash. Rash essentially self-resolved. On Day 5 developed left axillary lymphadenopathy that self-resolved on Day 11.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,PVT,None,None,None,,Bee allergy,"['Injection site erythema', 'Injection site rash', 'Lymphadenopathy', 'Rash papular', 'Rash pruritic']",1,MODERNA,IM 932510,NM,23.0,M,"Patient fainted after receiving vaccine/ Pt was monitored in observation chair for 15 minutes, blood pressure, and heart taken within normal limits/ Patient stated he wasnt concerned because this happens to him everytime",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PHM,,,,,,['Syncope'],1,MODERNA,IM 932511,NY,29.0,F,"Diffuse Myalgias, chills, low grade fever requiring Tylenol day after vaccination. Now resolved. Round, erythematous, flat, tender area on arm about 2 cm inferior to injection site. First noticed 3 days after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/01/2021,,PVT,"Yaz, bupropion",None,None,,Sulfa,"['Chills', 'Injection site erythema', 'Injection site pain', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932512,OR,43.0,M,"Woke up in the morning with soreness in wrist and elbow and practically zero use of my left hand. Woke up on left side so just assumed hand was asleep. After 15 minutes of no improvement, I started to panic thinking I was having a stroke. Realizing I had no other symptoms and was feeling fine otherwise I knew that likely wasn't the case. Besides having zero strength (I did have feeling) my hand would curl inward toward my body. I could manipulate with my right hand by it would always curl back in. I was barely able to grip, would actually have to manipulate my fingers into a grasp, couldn't do it on it's own, and holding something as light as my cellphone would cause my hand to turn down towards the floor. Pain level I would only describe as soreness in my wrist and elbow. Annoying but not painful. It's now over 24 hours since symptoms first appeared and besides some slight weakness in the hand I would say I'm 95% better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,None,None,Hypertension,,Amoxicillin,"['Arthralgia', 'Asthenia', 'Grip strength decreased', 'Muscle strength abnormal']",1,PFIZER\BIONTECH,IM 932513,VT,73.0,F,"Skin beneath the bandaid became very red and raised. The square are under the bandaid where the injection was given, was completely normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,PVT,none,none,none,,none,"['Erythema', 'Rash']",1,PFIZER\BIONTECH,IM 932514,CA,42.0,F,"Ten minutes after vaccine administration patient started complaining of n/v, palpitations, lightheaded and was observed with cold clammy skin and tachycardia. Upon observation 911 was called.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,WRK,,,,,,"['Cold sweat', 'Dizziness', 'Nausea', 'Palpitations', 'Tachycardia', 'Vomiting']",1,MODERNA,IM 932515,OH,73.0,M,Resident appeared to be jaundice with yellow skin and eyes. Resident also complained of not feeling well. Urine was dark yellow. Resident short of breath. Resident was admitted to hospital and diagnosed with post-covid pneumonia.,Not Reported,,Not Reported,Yes,,Not Reported,Y,12/29/2020,12/31/2020,2.0,SEN,"Asprin, cyanacabalmin, dulpxetine, lasix, isosorbide, Slisinop","COPD, PTSD, CAD, BPH, Post COVID","CAD, COPD, PTSD, BPH",,"PCN, Lactose intolerant","['COVID-19 pneumonia', 'Chromaturia', 'Computerised tomogram', 'Dyspnoea', 'Jaundice', 'Laboratory test', 'Malaise', 'Ocular icterus', 'Yellow skin']",1,PFIZER\BIONTECH,IM 932516,IN,58.0,F,"Chills, body aches Took Tylenol and advil.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Hyzaar. Vitamin D. Nexium,Head cold 1 week prior. Covid tested negative.,HTN. GERD,,Sulfa Lisinopril,"['Chills', 'Pain']",2,PFIZER\BIONTECH,IM 932517,MT,29.0,M,Chills followed by a fever. Fever broke within 4 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PUB,None,None,None,,None,"['Chills', 'Pyrexia']",UNK,MODERNA,SYR 932518,TX,35.0,F,Severe shoulder pain around injection site. Sharp pain including aching. Unable to lift or move arm without severe pain. Pain is now going on for 11 days. First 5 days were intense and severe. I was taking ibuprofen and Tylenol to help. Then the pain got better for 4 days. Day 10 the pain is back and severe again. Can?t move my arm without severe pain. Cannot lift it or sleep on it. Pain is in the shoulder area and also radiates up the neck at times and aches down to the forearm at times.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,Trazadone Adderall Ibuprofen Tylenol,None,None,,None,"['Injected limb mobility decreased', 'Injection site pain', 'Neck pain', 'Pain', 'Pain in extremity', 'Sleep disorder']",1,MODERNA,IM 932519,CA,29.0,F,"About 8 minutes after receiving injection, Pt stated that she wasn't feeling well. She passed out for about 2 minutes. Pt came too and was taken to ER via wheel chair. at ER pts bp was 69/33 HR:42 O2 was 100%. pt was pale and diaphoretic.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/10/2021,0.0,PVT,Levonorgestrel (MIRENA) 20 mcg/24 hr,none,none,,NKDA,"['Hyperhidrosis', 'Loss of consciousness', 'Malaise', 'Pallor']",1,MODERNA,IM 932520,VT,32.0,F,First noticed redness and itching at site of injection approximately one week after injection. Continue to have redness (large circle) and itching at injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,,None,None,,None,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 932521,AR,47.0,F,Severe itching and small rash on legs about 40 hours after the vaccine was given.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,PHM,,,,,Penicillin,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH,SYR 932522,MA,61.0,F,"Generalized body aches, headache, stomach upset, sweating, sore throat, slight cough and rhinorrhea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Abdominal pain upper', 'Cough', 'Headache', 'Hyperhidrosis', 'Oropharyngeal pain', 'Pain', 'Rhinorrhoea', 'SARS-CoV-2 test negative']",UNK,MODERNA,IM 932523,VA,44.0,F,"Large, lemon size swollen area in the axillary armpit. Area is marshmellowy feeling, not hard nor lumpy. Area aches and appears to be growing in size",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,"Claritan, Olly's Women's Vitamins, Zinc, Vitamin D, DHEA, Omega 3 Fish Oil, Thermo-Fight X dietary supplement","None, healthy",None,,"Penicillin, brewer's yeast, grass","['Feeling abnormal', 'Lymphadenopathy', 'Pain']",2,PFIZER\BIONTECH,IM 932524,OH,23.0,F,"hives on trunk and face, scratchy throat, prescribed steroids",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,WRK,gabapentin duloxetine hydroxyzine trazodone advil migraine,,migraines juvenile arthritis,,cinnamon,"['Throat irritation', 'Urticaria']",1,MODERNA,IM 932525,,34.0,F,"Fever, cough, chest pain, SOB, vomiting, and fatigue 4 days post vaccination. Seen in ER - Covid-19 test negative, diagnosis viral syndrome.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/28/2020,4.0,PVT,,,,,,"['Cardiac function test normal', 'Chest pain', 'Cough', 'Dyspnoea', 'Fatigue', 'Pyrexia', 'SARS-CoV-2 test negative', 'Viral infection', 'Vomiting']",1,MODERNA,IM 932526,MO,66.0,F,"After the first shot I had a very sore shoulder/deltoid area that started about 6 hours after the shot and lasted 3 days. After the second shot, I had mild soreness in my shoulder/deltoid that started about 3 hours after the shot and lasted 1 day. I also had a reaction on my skin in the L shoulder area - red with mild swelling and some itching. The size of the redness was about 2 in diameter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,UNK,"valacyclovir 500 mg, Calcium D 600 mg 2 x day",None,None,,No,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling']",2,PFIZER\BIONTECH,IM 932527,,43.0,M,"About 12 hours after vaccine #2: - Hives on left back, arm, face. Resolved with Benadryl within 4 hours. - Headache for about 30 hours - body aches for about 30 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,,,,,,"['Headache', 'Pain', 'Urticaria']",2,PFIZER\BIONTECH,IM 932528,MD,40.0,F,"Chest tightness, nasal congestion, light headedness within 15 minutes of injection. 2 hours later chills, headache, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/10/2021,0.0,PHM,None,None,Endometriosis,,NKA,"['Chest discomfort', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Nasal congestion']",1,MODERNA,IM 932529,WA,41.0,F,"About 5 min after getting the first dose, I felt numbness in my left hand. I was monitored for 60 min and they did blood pressure and oxygen check. about 10 min in, I felt a little funny in my mouth, like a little bit of swelling, but never to the point of issue with breathing or swallowing. Numbness seemed to have subsided by the 60 minute time and I went home. No other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"Fluoxetine 30 mg, Vitamin D 2000 mg",none,none,,none,"['Hypoaesthesia', 'Mouth swelling']",1,PFIZER\BIONTECH,SYR 932530,NY,49.0,F,"trouble swallowing, throat closing sensation. given epi 0.3mg IM, benadryl 25mg, pepcid 20mg, prednisone 60mg. symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,WRK,none,traumatic brain injury 2015,none,,shellfish iodine,"['Dysphagia', 'Throat tightness', 'Tryptase']",1,MODERNA,IM 932531,MA,22.0,F,Fatigue weakness fever back pain diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,,,,,,"['Asthenia', 'Back pain', 'Diarrhoea', 'Fatigue', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 932532,MA,23.0,F,"injection site pain, headache, muscle pain, joint pain, nausea/vomiting, chills, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Birth control,None,None,,None,"['Arthralgia', 'Chills', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 932533,IL,56.0,F,Sore arm and tingling in fingers,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,Zyrtec diltiazem vitamin d ecotrin metformin pantoprazole multivitamin montelukast Wellbutrin Took Benadryl thirty minutes prior to vaccination,None,GERD coronary vasospasm environmental allergies vitamin d deficiency anxiety obesity hyperglycemia degenerative disc disease irritable bowel syndrome Breast cancer in 2019 -cured,Shingrix 12/30/19 age 55 6/11/20 age 56 sore arm and erythema at injection site,Levoquin nickel birth control pills hydrocodone and an unknown allergy causing angioedema and urticaria,"['Pain in extremity', 'Paraesthesia']",1,PFIZER\BIONTECH,SYR 932534,LA,28.0,F,"Systemic itching, systemic tingling, Hypotension, syncope, Bradycardia, injection site swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Nexplanon implant, Vitamin D 4000 IU FQ, Fish Oil supplement",Viral Respiratory Illness - 2 weeks prior,History of Vasovagal Syncope,,"Ciprofloxacin, Levaquin, Erythritol","['Bradycardia', 'Hypotension', 'Injection site swelling', 'Paraesthesia', 'Pruritus', 'Syncope']",UNK,PFIZER\BIONTECH, 932535,WA,45.0,F,"About 9 minutes after receiving the vaccine the fingers on my left hand started going numb. I started shaking and breaking out in hives. The nurse took my blood pressure and it was elevated. They quickly walked me down to the emergency department where they started an IV. Medications I was given was diphenhydrAMINE, famotidine, MethyIPREDNISolone sod succinate 0.9% NaCI (NS), acetaminophen. Cardiac monitor and saline lock maintenance. Image testing done was EKG. I got to the emergency department at 11:45 am and was discharged at 3:49 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,None,None,None,,None,"['Blood pressure increased', 'Electrocardiogram normal', 'Hypoaesthesia', 'Tremor', 'Urticaria']",1,MODERNA,IM 932536,NM,48.0,F,Woke up in middle of night with fever and chills and body aches. Arm very sore and hard to lift. Tylenol taken with not too much relief. Slept most of the day. Second day arm is much better and can move more. Body is still achey.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,UNK,"Montelukast, fexafenadrine,flonase",None,"Allergies to cats, dogs, pollens from grass, trees, and weeds",,None,"['Chills', 'Pain', 'Pain in extremity', 'Pyrexia', 'Sleep disorder', 'Somnolence']",2,PFIZER\BIONTECH,IM 932537,AL,67.0,M,Fever - began about 1:00 pm on day following my injection. Temperature of 101.7 at 1:00 pm - declined to 100.8 by 4:40 pm - declined to 97.8 by 7:00 pm. My temperature was 96 at 8:00 am this morning.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,SCH,Zrytac; multi-vitamin;,Sinus infection,None,,None,"['Body temperature increased', 'Pyrexia']",1,MODERNA,SYR 932539,FL,48.0,F,"On the 4th day following vaccination woke up with severe vertigo, nausea, vomiting. Following day developed shingles rash. Was seen by my PCP on Monday and started on antiviral med.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2000,01/02/2021,7309.0,UNK,"levothyroxine, metformin, pepcid, sertraline",none,"hypothyroid, GERD",,none,"['Herpes zoster', 'Nausea', 'Rash', 'Vertigo', 'Vomiting']",1,MODERNA,IM 932540,VT,34.0,F,A have raised itself on 1/8/2021 at the injection site (left arm deltoid). The hive started at 2 inches diameter and is now about 3 inches diameter. Give us slightly sensitive to touch. On the left collarbone is also an inflamed lymph node.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,PUB,"Vitamin D, Lysine, GABA, Vitamin C, probiotic",None,None,,None,"['Injection site swelling', 'Lymphadenopathy', 'Tenderness', 'Urticaria']",1,MODERNA,SYR 932541,IL,38.0,F,"Started with chills about 10.5 hours after shot. Took temperature and noted a fever of 101.1F at the 12 hour mark along with a headache and fatigue. Improved moderately with taking ibuprofen and rest, fever ended after 24hours post vaccine. Lingering headache for the next 12 hours. Completely resolved at 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Synthroid, biotin, ashwaganda, hyaluronic acid, Claritin,",None,Hypothyroid,,Penicillin,"['Chills', 'Fatigue', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 932542,TX,31.0,M,"Symptoms: 104.7 Fever, body aches, chills, headache, joint pain, fatigue. Sweating profusely at night. Treatment: Tylenol and ibuprofen Outcome: Tylenol would lower fever to about 100 degrees and then fever would come up again to 103 degrees plus.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,WRK,Melatonin,Had Covid from 12/14 until 12/30,None,,None,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Pain', 'Pyrexia']",1,MODERNA,IM 932543,MN,31.0,F,"Noticed burning in left forearm immediately after vaccine, within 1 min. Symptoms progressed to feeling hot, flushed, and tachycardia briefly around 5 min. 10 min developed a pressure in my chest, and dizziness. Within 20 min, developed itching, flushing and hives specifically on left arm, hand, and across chest. Within 45 min, both ears and forehead covered with hives. Hospital staff made me go to ED. Within ED hives continued to progress across the chest and bilateral arms and wrists. Received 50mg of Benadryl, and 40mg of prednisone. Symptoms improved but did not resolved. 3 hrs following vaccine, bilateral lip swelling. Took 40mg of percribed pred and 25mg of Benadryl again around 4pm. Within 12 hrs, significant diarrhea. Hives resurfaced on face, bilateral wrists, arms, and ears around 645 on the 12/29. Fever 100.3 noted on 12/29-12/30. Intermitted hives, and lip swelling remained until 1/1. Nausea diarrhea and body aches until 1/2.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Birth control pill,none,None,,Walnuts and pineapple,"['Burning sensation', 'Chest discomfort', 'Diarrhoea', 'Dizziness', 'Feeling hot', 'Flushing', 'Lip swelling', 'Pain', 'Pruritus', 'Tachycardia', 'Urticaria']",1,PFIZER\BIONTECH,IM 932544,IN,38.0,F,"Developed body aches, fever and malaise at approximately 12 hours after vaccination that lasted until 36 hours post vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,None,COVID,None,,Bee venom,"['Malaise', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,ID 932545,CO,78.0,F,"Electric like jolt continuous from shoulder to hand. Later DX as a injury to the nerve at the site of the vaccination. Sent to urgent care told to take Tylenol, and ice the area. They referred to physical therapy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,PVT,"Atorvastatin40mg, lamotrigine, Sumatriptan. Multivitamin, Vitamin D3, aspirin, turmeric, omega3, coq10,",no,no,,"codeine, morphine, fentanyl.","['Electric shock sensation', 'Injection site injury', 'Nerve injury']",1,MODERNA,SYR 932546,MD,51.0,F,With in 6 hours a sore arm from shoulder to elbow with a large Angioedema under the skin protruding about the size of a soft ball. Edema slowly reduced to subcutaneous. Starting on 1/9/2021- a quarter size red Angioedema visible topically with a tennis ball size edema. On 1/10/2021 site is enlarged to the size of a half dollar. Currently tracking the size.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,OTH,None,None,"Ehlers danlos, HX VTE,",Tetanus allergy in childhood,"Latex, CT contrast","['Angioedema', 'Injection site oedema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 932547,IN,56.0,M,"Fever of 102, waxed and waned over 12 hours with diffuse myalgias.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/09/2021,8.0,UNK,None,None,None,,None,"['Feeling abnormal', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932548,MA,25.0,F,"Moderna COVID-19 Vaccine EUA 8 days post injection- erythematous, mildly hard, swollen, itchy reaction at injection site consistent with a vaccine given as a subcutaneous injection, not an intramuscular injection. Began 1/4/21 at night, grew in size overnight. 1/5/21, iced the area and took an antihistamine. By 1/6/21 reaction was resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,01/04/2021,8.0,PVT,Vitamin D Vitamin C Zinc Calcium Iron Dexmethylphenidate,None,None,,Azithromycin Amoxicillin,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 932549,WI,34.0,F,"One week after injection, I developed swelling, hives, itching and redness at the site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/10/2021,7.0,PVT,"Effexor, Mirena IUD, ibuprofen, lisinopril, amlodipine, bupropion",None,"Elevated blood pressure, kidney atrophy, pituitary adenoma, anxiety, major depressive disorder",,Relpax,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria']",1,MODERNA,IM 932550,CA,30.0,F,"Five minutes after the injection patient became flushed and dizzy, with a report of minimal nausea. She was moved to a lab draw chair, placed in Trendelenburg position, vital signs were stable, including pulse, blood pressure and oxygen saturation. She was in this position for greater than 15 minutes, it took 30 minutes for her be able to stand. She remained another 15 minutes, and stated she felt back to baseline before leaving.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,WRK,Unknown,None,None,,Unknown,"['Dizziness', 'Dysstasia', 'Flushing', 'Nausea']",1,MODERNA,IM 932551,WI,37.0,F,"Just wanted to report symptoms I experienced which I don't think are necessarily adverse bit just side effects, which were sore arm starting same day, and then day after had body aches, fatigue requiring a nap, and intermittent headache mild but felt like burning near right occipital area which was different from my normal occasional headache, no fever, and had slight runny nose lasting for 2 days, then I felt fine, I plan to get the booster.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,UNK,Levothyroxine Vit d 3 Multivitamin,None,"Post-ablative hypothyroidism Known elevated ANA tiger without specified connective tissue diagnosis, joints are hypermobile",,"Erythromycin-hives Keflex-hives Allergic to dust, pet dander, seasonal allergies","['Burning sensation', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Rhinorrhoea']",1,MODERNA,IM 932554,,22.0,F,Headache. Monitored for 35 minutes post injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/10/2021,01/10/2021,0.0,PVT,,,,,,['Headache'],UNK,PFIZER\BIONTECH, 932555,PA,35.0,F,Left axillary swollen lumps/lymph nodes? Tender to touch. Hard to move left arm. Never hapepned before.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/09/2021,17.0,MIL,"Escitalopram, spironolactone, amphetamine salts, naltrexone, trazodone, estradiol cream, tretinoin cream, clindamycin/benzoyl peroxide cream",None,"Acne, PTSD, osteopenia",,NKDFA,"['Injected limb mobility decreased', 'Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 932556,IN,31.0,F,Fever 102.2F fatigue Chills Body aches Nausea Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,OTH,Prenatal vitamins,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932557,MD,50.0,F,"Lot number maybe a Number two or a Z, not sure by the writing, 01ZLZOA or 012L2OA Next day feeling tightness in chest and lightheaded, and shortness of breath, some right side jaw pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PUB,Vitamin D in AM,No,No,,No,"['Chest discomfort', 'Dizziness', 'Dyspnoea', 'Pain in jaw']",1,MODERNA,SYR 932558,PA,45.0,M,"Patient developed chills/shivering/tingling day 4 post-injection. The episodes are occurring every 10 minutes and last 30-45 seconds. Symptoms continue at day 11 post injection. Symptoms are similar to the patients pre-ictal aura. However, no generalized seizures have occurred.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PVT,"Lyrica, Vimpat, Lisinopril",none,"Epilepsy, Epithelioid Sarcoma, Hypertension, Obesity, Sleep apnea",,Dilantin,"['Chills', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 932560,OH,60.0,F,"Red, swollen, hot, hard center, itchy, painful to touch. Started as a quarter size patch and each day increased in size to about 3 inch by 5 inch patch as of today (day 4). Used cold compress several times daily.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,"Losartan 50mg , levothyroxine 50mcg, Lantus insulin, Humalog insulin, omeprazole, ibuprofen, tylenol, asprin 81mg, zinc 50mg, vitamin c, one a day vitamin,",none,"diabetic, high blood pressure",,cipro - muscle cramps,"['Erythema', 'Feeling hot', 'Induration', 'Pruritus', 'Swelling', 'Tenderness']",1,MODERNA,IM 932561,AL,26.0,F,"1/6 got vaccine don?t hurt- Initially slightly sore arm a few hours after vaccine 1/7 Next day when woke up very sore arm and shoulder and feeling not 100% 1/7 Mid morning, Headache, stuffy head, Body aches all over, joint pain all over, chills, low grade fever 99/100 by noon, all of these side effects lasted 1/8 and subsided into 1/9 feeling almost 100% better 1/10",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,SCH,Adderall Zoloft Yaz Xanax as needed,None,None,,Penicillin Pollen,"['Arthralgia', 'Chills', 'Headache', 'Nasal congestion', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 932563,IN,56.0,F,"1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, total body/muscle/joint aches, migraine headache, nausea, heart palpitations, as well as very sore, swollen arm. Had to spend the day in bed. Most symptoms relieved by the next 24 hours except arm pain and fatigue. 2nd vaccine: Similar, but worse symptoms developed approximately 12 hours after vaccine. All of the aforementioned symptoms, but fever of 101.4 and arm wasn't quite as sore. As above, had to spend a day in bed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,Centrum Silver multivitamin,none,none,,none,"['Arthralgia', 'Chills', 'Fatigue', 'Migraine', 'Myalgia', 'Nausea', 'Pain', 'Pain in extremity', 'Palpitations', 'Peripheral swelling', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932564,FL,63.0,F,"Within 1 h, pain from injection site to neck. Neck pain felt like meningitis pain. Diarrhea, generalized not feeling fell. On awakening 01/09/21, low grade fever of 99.9, chills, fatigue, generalized malaise, brain fog, & confusion. I was in the shower & yelled for my husband to help me brush my wet hair & asking why it was wet. When I was brushing my teeth, I asked my husband to get me a toothbrush because I could not brush my teeth with ""this noodle"". Doing ""goofy"" things on 01/09/21 & 01/10/21. Realizing I am doing this which is not normal. I am an RN & this is not normal for me. On 01/07/21 @ 6:30 pm took 50mg Benadryl, 200mg Advil & Tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,OTH,"Losartan, Zetia, Zocor, Vitamin D3, B12, Aspirin, Zinc with Elderberry,",steroid injection to knee on 1/3/21,none,,"Shrimp. Swordfish, Codeine, Lisinopril, Phenergan, Amoxicillin","['Chills', 'Confusional state', 'Diarrhoea', 'Fatigue', 'Feeling abnormal', 'Injection site pain', 'Malaise', 'Neck pain', 'Pyrexia']",1,MODERNA,IM 932565,,34.0,F,Myalgias x24h Nausea x 18h Chills x36h Fever (Tmax 103.8F) x28h Headache >48h,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Buproprion Escitalopram Prenatal vitamin,None,,,Sulfa Amoxicillin Nickel,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932566,PA,36.0,F,Due date 1/20/21. No adverse events at this time,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/10/2021,1.0,PVT,Prenatal vitamin,"COVID-19 positive on 12/26/20. Tested for COVID 12/26/20 the same day COVID symptoms started. Received first dose of vaccine 12/18/20, had contact with a primary source 12/22/20.",None,,Sulfa drug allergies,"['Maternal exposure before pregnancy', 'No adverse event']",2,PFIZER\BIONTECH,IM 932567,KS,38.0,F,"Sore arm day 1-3, bruising occurred day 2. Mild fever (approximate 99 deg) beginning around 5:30pm-day of injection lasting 12 hours. Body Aches and Mild Headache beginning the evening of day of injection lasting through day 2. Body rash (non-itchy) on trunk, low back, inside of upper arms, upper chest beginning on day 2 post injection lasting until day 3. Treatment: IBU every 4-6 hours prn.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,"Women's MyKind Organic Daily Multivitamin, Toji daily vitamin, daily Calcium supplement, daily biotin supplement.",Experienced a bout of cold sores on lip 1 week prior to vaccine. Took oral Valacyclovir.,None,,Vantin medication,"['Contusion', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia', 'Rash']",1,MODERNA,SYR 932568,OH,52.0,M,10 days after receiving the injection a dime sized bump appeared at the injection site - with slight redness and itching On day 11 it is not getting any worse and perhaps is slightly less,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/09/2021,9.0,PVT,Coumadin Sertraline Lorazepam Hydrochlorothiazide Linsinopril Vitamin D Fish oil Multi vitamin CBD oil,None,Anti phospholipid antibody syndrome (APS),,I have observed none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 932569,TN,32.0,F,Developed covid-19 infection,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,01/05/2021,14.0,UNK,Ambien,None,Asthma,,Macrobid,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 932570,IA,59.0,M,"Cold Sores across bottom lip, diarrah, vomiting, fever, tired",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/09/2021,4.0,PUB,Omerprazole 20mg Tinolol Maleate eye drops,None,Acid Reflex,,Non Known,"['Diarrhoea', 'Fatigue', 'Oral herpes', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 932571,CA,29.0,F,"Muscle spasms and pain (pins and needles sensation), extreme fatigue, headache, debilitating body aches for 24+ hours, abdominal pain for 2 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PVT,Omeprazole 20 mg,,"GERD, gastroparesis",,,"['Abdominal pain', 'Fatigue', 'Headache', 'Muscle spasms', 'Myalgia', 'Pain', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 932572,NY,32.0,F,"Fever, chills, soreness at insertion site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,,,contact dermatitis/eczema,,"bacitracin, benzalkonium chloride","['Chills', 'Injection site pain', 'Pyrexia']",UNK,MODERNA, 932573,NY,49.0,F,"Approx 35minutes after vaccine i experienced sneezing ,scratchy throat and itchy yes, took Allegra with good effect. Arm soreness developed about 8 hours after vaccine, woke next morning with fever 100.9, severe body aches, headache, nausea, weakness and fatigue, decreased appetite. In addition, as the day went on I experienced a shallow cough, high pulse rate (130), tongue twitching and just felt aweful. Slept on and off all day, sx lasted the entire day. Took Tylenol throughout the day for the the fever. I awoke 3:30 am today, 1/10/21 with fever 101.5, took more Tylenol, still headache and feel tongue twitchiness however muscle aches, body aches, nausea, decreased appetite and fatigue have subsided. I took 600mg Advil around 9am today and have been gradually feeling much better as of now 1:30pm. As a side note, I did have COVID 19 illness mildly in March 2020. It was dx'd with PCR testing and my sx were loss of taste/smell, nausea, weight loss, bursted eye vessel, slight respiratory sx, I recovered well and had a follow up negative test 2 weeks after. Thank you.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PVT,"Losartan, Xifaxin, Vitamin D, Vitamin B, Colace, Lactobacillus",none,"migraine, HTN, Diverticulosis",,seasonal allergies,"['Asthenia', 'Cough', 'Decreased appetite', 'Fatigue', 'Feeling abnormal', 'Headache', 'Heart rate increased', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'Sneezing', 'Throat irritation']",UNK,MODERNA, 932574,NY,33.0,F,Ipsilateral lymphadenopathy and axillary pain radiating to wrist along radial nerve,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,PVT,None,None,None,,None,"['Arthralgia', 'Axillary pain', 'Lymphadenopathy', 'Pain']",1,MODERNA,IM 932576,MO,39.0,M,Significan painful axillary adenopathy on the side of the injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,,,,,Aspirin,"['Axillary pain', 'Injection site swelling', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 932577,IN,58.0,F,18 hours after vaccine wakened with severe headache lasted aprox 18 hours then was just mild for remainder of 30 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Metoprolol, zyrtec,cymbalta, januvia, glumetza, estrogen.",None,"Pulmonary hypertension, asthma allergies borderline diabetes",,"Latex, avelox, morphine, bananas, grapefruit, eggs.",['Headache'],1,PFIZER\BIONTECH, 932578,WV,51.0,F,"Sever muscle pain in shoulders, neck, and back. Severe headache and skin was sensitive to touch. Chills and sweats but no fever. Lasted about 36 hours. Some slight nausea and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,"Venlafaxine ER 75mg, Metformin 500mg x 2 as a preventative, Loratadine 10mg,Hydrochlorithyzide 25mg, Vitamin D2 50,000IU,Cetirizine 10mg, Famotidine 40mg, Trulance 3mg, Vascepa 1gm x 4, NAC 600mg, Niacin 500mg, Potassium 99mg, Adults 50+ Mu","I was diagnosed with COVID-19 on December 5, 2020.",na,,na,"['Arthralgia', 'Back pain', 'Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Nausea', 'Neck pain', 'Pain of skin']",1,MODERNA,IM 932579,IN,50.0,M,Chills nausea aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/09/2021,8.0,UNK,Vitamins C/D K3,,Stage 2 Kidney Disease,,,"['Chills', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,SYR 932580,CA,56.0,F,left arm mild sore,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,"Atorvastatin, Aspirin, centrum vit, B complex sup, hair vit",none,none,,none,['Pain in extremity'],1,MODERNA,SYR 932581,NJ,26.0,F,"FEVER 101, BODY aches, chills- 2 days took tylenol, dry cough, sore throat, runny nose, headache- 3 days took tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"advil cold and sinus, Tylenol, multivitamin, fluvoxamine, vyfemla, probiotic, zyrtec",,"exercise induced asthma, anxiety, ocd","COVID VACCINE SERIES 1 ON 12/19/20 HAD BODY ACHES FOR TWO DAYS, SUBSIDED WITH ADVIL",latex,"['Chills', 'Cough', 'Headache', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'Rhinorrhoea']",2,PFIZER\BIONTECH,IM 932582,IN,58.0,F,"10 hours after shot - sore arm, 2 hours later headache, 2 hours later fever, muscle ache, chills, basically flu like symptoms. My skin hurt everywhere",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Bupropion, low dose aspirin, chlorthalidone, estradiol, allergy tablet, potassium",None,Seasonal Allergies,,Erythromycin,"['Feeling cold', 'Headache', 'Influenza like illness', 'Myalgia', 'Pain in extremity', 'Pain of skin', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932583,IL,40.0,F,"Fever, chills, body aches, nausea, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,B12 complex vitamin,None,None,,None,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932584,IL,54.0,F,"Diarrhea lasting for 22 day, RIGHT UPPER QUADRANT pain for 22 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/20/2020,1.0,PVT,Venlafaxine 150 mg day Fish oil Vitamin C Vitamin D Multivitamin,None,None,,NONE,"['Abdominal pain upper', 'Diarrhoea']",1,PFIZER\BIONTECH,IM 932585,CO,40.0,U,"COVID VACCINE MODERNA UNDER EUA During her 15 minute post-vaccination observation period, patient reported feeling lightheaded and very warm. She had flushing on her face and neck. No rash, hives, angioedema, or breathing difficulty. No fall, no loss of consciousness. The client denied allergy history but did say the same thing happened to her during a root canal when the local anesthetic was injected in to her gums. This RN along with another RN observed the client for approximately 25 minutes total then discharged her home. Approximately 15 minutes in to this observation period, the client reported improvement in her symptoms and the flushing appeared to be improving. The patient did not wish to call for a ride or seek EMS. At time of discharge, patient agreed to pull her vehicle to the side of the road and call for assistance if, at any time, she did not feel well on her drive home. Interventions implemented were lying down with feet elevated, smelling ammonia salts, application of cool compress to head and neck, drinking juice, and eating snack bar. I called the client two hours later to confirm she arrived home safely. The patient confirmed save arrival home and reported feeling much better. She said she was planning to follow up with her PCP about her response and also had a partner at home to observe her. Associate program manager notified of event details.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,Unknown,Non per patient report,None per patient report,,None per patient report,"['Dizziness', 'Flushing', 'Skin warm']",1,MODERNA,IM 932586,AZ,64.0,F,"Developed significant aching in lower extremities, HR 100, Temp 100.4, slight nausea, general flu like feeling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,Synthroid Lisinopril Gemfibrozil,None,,,None,"['Body temperature increased', 'Influenza like illness', 'Nausea', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 932587,TX,51.0,F,No symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/08/2021,9.0,UNK,"Lisinopril, norvasc, lovastatin",,"Bronchiectasis, asthma, HTN, hyperlipidemia, prediabetes",,"Sulfa, PCN, aspirin",['Red blood cell count increased'],1,MODERNA,IM 932588,IN,39.0,F,"Fever, chills, weakness, fatigue, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Fluconazole 150mg once weekly,None,None,,Clindamycin Monistay,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 932589,SC,31.0,F,"Pfizer-BioNTech COVID-19 Vaccine Nausea, diarrhea, myalgias, cephalgia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PUB,"Sertraline, Fexofenadine, Adderall",No,"Anxiety, ADHD, Allergic Rhinitis",,NKDA,"['Diarrhoea', 'Headache', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,IM 932590,FL,49.0,F,"7 days after vaccine administration, I noted a red area a couple of inches below the injection site that was itchy and warm to the touch. I kept an eye on it. When I awoke the following morning, the reddened area was larger, still warm to the touch, slightly swollen and itchy. On the 3 morning, the area was larger (roughly 10cm wide x 7-8cm tall), still reddened, swollen, warm to the touch and itching. Today is day 4 of the reaction. It seems to be about the same size or slightly larger than yesterday, and it is still reddened, swollen, warm to the touch and itching. I have applied topical diphenhydramine over the last couple of days as needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,Bystolic 15mg Qday Omeprazole 40mg Qday Vit D 2000units Qday Airborne prn (none taken during the time between vaccination and start of reaction),None,Hypertension Allergic rhinitis GERD,"tetanus vaccine, early 1990's, was unable to move arm for approx 5-7 days, full recovery without intervention","Sea and ski sunscreen and Banana boat sunscreen - rashes, burn and blisters","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 932591,VA,26.0,F,Fever ranging from 100.1F-102F Body chills Bodyaches Headaches Dizziness Sorness and swelling at the injection site Took Tylenol to treat fever and bodyaches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,UNK,,,,,Contrast dye,"['Chills', 'Dizziness', 'Headache', 'Injection site pain', 'Injection site swelling', 'Pain', 'Pyrexia']",UNK,MODERNA, 932592,AZ,54.0,F,"Pfizer-BioNTech COVID-19 Vaccine. Chills, headache, body aches, nausea, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,PVT,,,,,,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,IM 932593,,27.0,M,"8 hours after vaccination - injection site tenderness 12 hours after vaccination - fatigue, malaise 15 hours after vaccination - headache, fever, chills, tachycardia improvement in symptoms began at 36 hour mark and had resolved at 48 hour mark",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,none,none,hypertrophic cardiomyopathy,,sulfa drugs,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Pyrexia', 'Tachycardia']",2,PFIZER\BIONTECH,SYR 932594,TX,58.0,F,"Experienced light headedness, minimal chest tightness, increased HR and BP lasting 30 min, 4 days post vaccine injection. I usually have low BP and HR so was unusual to experience these symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/10/2021,3.0,WRK,Vitamin D Omega 3 supplement Multi vitamin Cosamine DS CBD 500mg prn,,,,aspirin,"['Blood pressure increased', 'Chest discomfort', 'Dizziness', 'Heart rate increased']",1,MODERNA,IM 932595,NJ,54.0,M,"Headache, exhaustion, sore all over",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,"Ozempic, Metformin, Jardinace, atorvastatin, carvedilol, quinapril, D3, multivitamin, Mucinex DM",Head cold,Diabetes & Hypertension,,NKA,"['COVID-19', 'Fatigue', 'Headache', 'Pain', 'SARS-CoV-2 test positive']",1,MODERNA,IM 932596,WA,66.0,F,"The concern was the gi symptoms,,,severe cramping nausea, vomiting and bloody stool",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"I had the chills and fever, 100.8, and joint pain but the concern was the nausea, vomiting cramping. It progressed to nausea vomiting with bloody stool by 01/09/2021 at night.",None,"Hypothyroid, arthritis, migraines intermittant mitral valve prolapse",,"Penicillin, ampicillin, erythromycin","['Gastrointestinal disorder', 'Haematochezia', 'Muscle spasms', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 932597,NY,49.0,F,Patient reported symptoms of numbness of lower jaw and difficulty swallowing 16 minutes post vaccination. Patient was familiar with symptoms of anaphylaxis due to her history of anaphylactic reactions to both shellfish and iodine. Patient was given an Epi-Pen (self-administered) and waited for an additional 45 minutes after initial vaccination. Patient also self-administered 25mg Diphenhydramine. Patient then left clinic and was later contacted by phone by Chief Medical Officer for follow up. Pt had admitted herself to the ED and received antihistamines and steroids. She then reported that she'd felt better but will remain in ED for observation.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/10/2021,0.0,PUB,None,None,None,,"Shellfish, Iodine","['Dysphagia', 'Hypoaesthesia']",1,MODERNA,IM 932598,NM,43.0,F,Moderate to sever Joint pain HA PHOTOPHOBIA Moderate soreness and swelling at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,OTH,,None,Chronic pain,"Fatigue, malaise with flu vaccine",Naproxen,"['Arthralgia', 'Headache', 'Injection site pain', 'Injection site swelling', 'Photophobia']",2,PFIZER\BIONTECH,IM 932599,IN,35.0,F,"Moderate axillary swelling and tenderness, same side as injection. Onset 1/9/21, no treatment sought as of now.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,PVT,Probiotic Magnesium,None,None,,Doxycycline:itching,"['Axillary pain', 'Oedema peripheral']",UNK,PFIZER\BIONTECH, 932600,MI,51.0,F,"Pt felt tingling and numbness in left jaw and ear area. A few minutes later, she felt it spread to her nose and other ear/jaw area. Then she experienced tongue heaviness and tingling. She was transported to the ED for further evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Hypoaesthesia', 'Paraesthesia', 'Paraesthesia oral', 'Tongue discomfort']",1,PFIZER\BIONTECH,IM 932601,KS,24.0,F,Dull Low back pain; sharp low back pain with long durations of lumbar extension. Symptoms subsided within 36 hours. Managed well with ibuprofen.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PUB,,,,,Sulfa drugs,['Back pain'],1,MODERNA,IM 932602,IN,46.0,F,Hives/itching,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Tums, milk of magnesia",,GERD,,None,"['Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,IM 932603,OH,31.0,F,"vaccine on 1/7 around 1130am. Onset of severe chills/shaking, fluctuating temperature (no fever), horrible aches and pains, significant fatigue, and persistent headache from about 3am the morning after (on 1/8) and lasting until bedtime that day. The next morning (1/9), most symptoms had resolved except for fatigue. I also experienced a new sx: severe pain and tightness in my chest/torso; was hard to breath normally and could not take a deep breath without experiencing significant pain. This lasted until about 3pm. Fatigue persisted the rest of the day. All symptoms had resolved by the next morning (1/10).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,"birth control (gianvi), singulair, zyrtec, daily women's multivitamin, buspirone, hydroxyzine",none,none,,none,"['Body temperature fluctuation', 'Chest discomfort', 'Chest pain', 'Chills', 'Fatigue', 'Headache', 'Pain', 'Tremor']",2,PFIZER\BIONTECH,SYR 932604,MI,43.0,F,"Numbness and tingling in both hands, down right leg. Patient observed for 30 minutes. No worsening of condition and patient declined further medical care.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,,,,,,"['Hypoaesthesia', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 932605,CA,29.0,F,"patient developed instant itch in throat after administration of vaccine 25mg PO Benadryl was given reassessment 5 minutes later throat itchy, denies wheezing or SOB. Additional 25mg PO Benadryl was given Patient devloped SOB, Epi pen adminstered 10:04am. EMS called for transport. SOB improved. Vital remained stable. EMS arrived and transported patient to hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/10/2021,0.0,PVT,unknown,no,unknown,,depo,"['Dyspnoea', 'Throat irritation']",1,MODERNA,IM 932606,UT,51.0,F,"I feel like my left ear is plugged. I don't feel any pressure, like when you are on an airplane and you ears need to pop but I can't completely hear out of that ear.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,"Venlafaxine, Levothyroxine, Trazodone, Topiramate, Atorvastatin, Diphenhydramine , Vitamin C, Vitamin D, Multi Vitamin",,,,,"['Ear discomfort', 'Hypoacusis']",2,MODERNA,IM 932607,IL,34.0,M,I had a rash about the size of a baseball at the injection site. It was noticed 8 days after the injection but I am not sure if it had been present prior to that. Just redness. No swelling or pain with it. By the evening of 1/9/2021 it had disappeared.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/08/2021,8.0,PVT,None,None,None,,None,"['Erythema', 'Injection site rash']",1,MODERNA,SYR 932608,NY,47.0,F,Moderna COVID-19 Vaccine EUA I developed the sudden onset of tinnitus (high-pitched constant ringing in both ears) about 30 hrs after receiving the vaccine. I have had associated feeling of fullness/popping in my ears as well. This has continued for 10 days without relief.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"Tamoxifen 20 mg daily, multivitamin, Vit D, biotin, glucosamine with chondroitin",none,none,,none,"['Acoustic stimulation tests normal', 'Ear discomfort', 'Tinnitus']",1,MODERNA,IM 932609,IN,44.0,F,"Moderate pain in the injection site (upper right arm) followed by severe fatigue, back ache, and a slight fever (37.8 Celsius). Symptoms started 8 hours after the vaccination. No treatment other than strict rest and ibuprofen taken once (600 mg).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,Pen VK 500 mg 1TID,,,,,"['Back pain', 'Injection site pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 932610,IL,59.0,F,"I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 2100 on 1/8, began to develop a lot of pain at the injection site. Within 2 hrs of that time, I developed other symptoms, which include total body (bone and joint) pain (especially in my knees), and what I would describe as a ""bad sunburn type"" rash across my cheek bones, bridge of my nose, and orbital area. Small raised bumps to this area, with swelling, and a feeling of pins and needles stabbing me all across my face. My airway was fine, and at no time did I feel shortness of breath. I was unable to sleep due to the bone and joint pain, and felt the need to walk continually (it was more painful to stay in one position). These symptoms persisted throughout the day (Saturday 1/9/21), noting at 5pm I described myself ""miserable"" to my friends and family. All symptoms described above, were at their most elevated intensity between the hours of 1700 - 0400. At 0400 Sunday (1/10/21) I felt a gradual release of the body aches, enough so that I could sleep until 0800. At this time, 1300 (Sunday 1/10) I note that I still feel ""flu type"" body aches, but constant pain has diminished in intensity by estimated 50%. The sunburn type redness and swelling across my face/orbital area has also less by 50% (there is still redness, mild swelling, warmth, and some raised bumps across this area; pins and needles feeling is gone).",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,UNK,ASA enteric 81 mg daily (take at 2200) Amlodipine 2.5 mg q day (take at 2200) Propranolol ER 60 mg BID (take at 0600 and 2200),None,Hypertension,,NKA,"['Arthralgia', 'Erythema', 'Feeling abnormal', 'Feeling hot', 'Influenza like illness', 'Injection site pain', 'Insomnia', 'Pain', 'Paraesthesia', 'Rash', 'Rash erythematous', 'Rash papular', 'Swelling']",2,PFIZER\BIONTECH,IM 932611,TX,75.0,F,"Swelling of lower lip; itching; severe, red, swollen welts all over body; tongue itching, then some swelling; swelling of lips and chin area; eye lids swelling almost completely closed. Began 01//05 early am; progressivegly worsening thru 01/08. Given steroid injection at doctors office and told to take Benedryl or Zytrec and Pepcid",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PUB,"losartan,100mg; amlodipine besylate 5mg; citalopram 40mg; pantoprazole 40mg; gabapentin 100mg; Bayer Low Dose 81mg; Calcium + D3 1000mg; Citrum Silver vit.;",None,High blood pressure,,None,"['Lip swelling', 'Swelling of eyelid', 'Swollen tongue', 'Tongue pruritus', 'Urticaria']",1,MODERNA,IM 932612,CO,32.0,M,Two weeks after injection I started to develop a bad outbreak of Varicella Zoster in the T4 dermatomal distribution. Began taking acyclovir po. Ongoing infection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,01/04/2021,14.0,PVT,,,,,,['Varicella zoster virus infection'],1,PFIZER\BIONTECH,IM 932613,LA,78.0,F,"Tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell, nausea, weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,"Metoprolol soccer 50mg, atorvistan 20mg, clopidegrel 75mg, Lexapro 10mg,isosorbid monotrat er 30mg, areds 2, vitamin d 5000, coq10 250mg, tums 1000mg, probiotics, restasis, alprazalom as needed,lanoprost 2.5mg",None,"coronary arterary disease, osteoarthritis",,sulfa,"['Arthralgia', 'Asthenia', 'Chills', 'Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH, 932614,TX,43.0,F,Throat closing Pruritic throat and tongue Tingling lips and tongue Throat clearing Hoarse voice,Not Reported,,Yes,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Synthroid 75 mcg Bystolic 10 mg,"Covid-19 on December 23, 2020","HTN, Hypothyroid, asthma",,NKDA,"['Dysphonia', 'Paraesthesia oral', 'Throat clearing', 'Throat irritation', 'Throat tightness', 'Tongue pruritus']",1,MODERNA,IM 932617,MI,79.0,M,"Slight dizziness upon awakening in the morning around 7:00 AM. dizziness faded through the day, but mild headache developed around 1;00PM. Symptoms not severe or incapacitating. Patient took two Tylenol caplets.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/10/2021,8.0,PVT,,,,,,"['Dizziness', 'Headache']",UNK,MODERNA,SYR 932618,IN,30.0,F,"The morning after the shot I woke up feeling achy and sore all over. I had muscle cramps throughout the day. Also, I was extremely tired for the entire day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,None,Beginning of Dec (12/9) - positive for COVID. No other known illnesses.,"GERD, Low iron",,Sensitivity to dairy,"['Fatigue', 'Muscle spasms', 'Pain']",1,MODERNA,SYR 932619,IL,43.0,F,"Headache, chills, body ache, severe fatigue, nausea. Symptoms were most severe about 16 hours after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 932620,,21.0,F,"On Friday, January 8 I experienced a headache for the remainder of the day following my vaccination. This headache went away when I woke up the following day. On Saturday, January 9 I experienced chills, nausea, body aches, and a stiff neck, along with pain in my left arm. The injection site was inflamed and painful. Most of these symptoms were relieved the following day. On Sunday, January 10 I experienced pain in my left arm that has travelled into my axillary area and my left shoulder. This has yet to be relieved. I am also erythemic at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Arthralgia', 'Axillary pain', 'Chills', 'Headache', 'Injection site erythema', 'Injection site inflammation', 'Injection site pain', 'Musculoskeletal stiffness', 'Nausea', 'Pain', 'Pain in extremity']",1,MODERNA,IM 932621,CA,34.0,F,"Pink, spotty rash on bilateral arms and legs. Flat. Not itchy or painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,"Claritin, D3, multivitamin, cranberry, probiotic, effexor ER",None,Seasonal allergies,,"Banana, avocado",['Rash'],1,MODERNA,IM 932622,KY,24.0,F,"Nausea, chills, fever (101.8� F), body aches, head ache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932623,IL,78.0,M,"Acute ischemic stroke, basilar occlusion",Not Reported,,Yes,Yes,,Not Reported,U,01/09/2021,01/10/2021,1.0,PVT,"amlodipine, atorvastatin, esomeprazole, metoprolol, omega-3, ticagrelor, cyanocobalamin",,"Hypertension, hyperlipidemia, coronary artery disease (s/p angioplasty)",,aspirin,"['Angiogram', 'Basilar artery occlusion', 'Computerised tomogram', 'Ischaemic stroke']",2,PFIZER\BIONTECH,IM 932624,VA,43.0,F,"Hives (face, neck, ribcage, stomach, arms, hands, back, legs, underarms, elbows), Swollen eyes; Swollen lips; Hard Ears; Warm Skin; Itching; Wheezing.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,"Daily Multi-vitamin, Elderberry, Vitamin D",None,Asthma,,"Medications- None; Food - Walnuts, Pine Nuts; Environmental - Polen, Dust, Mold, Animal Dander","['Ear discomfort', 'Eye swelling', 'Lip swelling', 'Pruritus', 'Skin warm', 'Urticaria', 'Wheezing']",1,PFIZER\BIONTECH,SYR 932625,NC,45.0,F,Chills Fever 103 NauseA Joint pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,WRK,81 mg aspirin Daily multivitamin Calcium/vitamin D,None,No,,Latex,"['Arthralgia', 'Chills', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932626,MD,31.0,F,"8 days after vaccine- all of a sudden had itchiness at vaccine spot. Raised lump, hot, itchy and red. No other symptoms at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/10/2021,8.0,WRK,None,None,None known,,None,"['Erythema', 'Injection site pruritus', 'Mass', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,SYR 932627,NJ,37.0,F,Currently 25 weeks pregnant. COVID positive on Jan 5th after exposure to asymptomatic contact. Developed COVID symptoms on January 4th with light dry cough and progressed on the 5th to fevers/chills etc. Jan 8th noticed wheals and itchiness at injection site. Persistent until today - mild in severity but continuous. Taking benadryl PO and topical cortisone.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,01/08/2021,12.0,PVT,Tylenol PRN and prenatal vitamins.,COVID (+) diagnosed on Jan 5th with symptoms.,none.,,NKDA,"['COVID-19', 'Chills', 'Cough', 'Exposure during pregnancy', 'Injection site pruritus', 'Pyrexia']",UNK,MODERNA,IM 932628,CA,31.0,F,"Right arm edema and rash around the injection site, with associated throat itching, right arm soreness and pruritis that began 7 days after vaccine administration. 8 days after the injection I awoke with severe nausea, lightheadedness and diaphoresis that lasted 30 minutes. The rash took 4 days to resolve.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,PVT,Combined progesterone-estrogen oral contraceptive (daily) Clindamycin phosphate topical gel (as needed),None,None,,None,"['Dizziness', 'Hyperhidrosis', 'Injection site oedema', 'Injection site rash', 'Nausea', 'Pain in extremity', 'Pruritus', 'SARS-CoV-2 test negative', 'Throat irritation']",1,MODERNA,IM 932629,CA,28.0,F,"12/18 VACCINATION 12/23 CAME HOME AT 7:30 AM FROM WORK. MY BODY WAS HURTING, SORE. SLEPT. WOKE UP 9-10; VOMITING BODY ACHES, HA. WENT TO ER. COULDN'T KEEP ANYTHING DOWN, EVEN MEDICINE. GAVE ZOFRAN, COVID TEST (NEGATIVE) FELT LIKE I WAS KNOCKED OUT. DIDN'T GET OUT OF BED FOR DAY. TEMP GOT UP TO 102. WITH TYLENOL, IBUPROFREN. BODY WAS SORE. THESE SYMPTOMS ARE STILL PRESENT. LINGERING COUGH. 1/1/2021 FEVERS. LASTED 1-2 DAYS. MUNICEX FOR COUGH AS NEEDED. NOT 100% BETTER, MAYBE 95%",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/23/2020,5.0,PVT,prenatals/daily,,HX ASTHMA,,Erythromycin,"['Body temperature increased', 'Cough', 'Headache', 'Pain', 'SARS-CoV-2 test negative', 'Vomiting']",1,PFIZER\BIONTECH,SYR 932630,NY,29.0,F,Heart burn (severe) unrelieved by tums or pepcid x 3 nights and 3 days Fatigue Malaise Generalized muscle pain and fatigue Mild nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Nuvaring,None,None,,NKDA NKFA,"['Dyspepsia', 'Fatigue', 'Malaise', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,SC 932631,GA,59.0,F,"Does not have Lot #. Left it at work. Dizzy 15 mins after. BP was high. Dizzy rest of day. Worked the next day was ok. Started driving the next day on interstate 12/25/20, and had chest pressure. Pulled of in to a hospital their and had testing done. Went home had dizziness still. Went to her MD, the doc changed her blood pressure meds. She doesn't have the dizziness and the chest pressure any more. Blood pressure is still high and monitoring it a few times a day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,WRK,Losartan potassium25mg,no,"high bp, obesity.",,no,"['Chest discomfort', 'Dizziness', 'Hypertension']",1,PFIZER\BIONTECH,SYR 932632,LA,48.0,F,"I contracted influenza B and covid. Diagnosis was made on January 4th, 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,01/01/2021,11.0,PVT,Nonenone,None,None,,None,"['COVID-19', 'Influenza', 'Influenza B virus test positive', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 932633,NC,29.0,F,"Red, hot, swollen arm at and around injection site lasting greater than 48 hours post vaccine administration. Bone pain, lymph node swelling, headache for 36 hours post.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,"Prenatal vitamin, probiotic, Vitamin D, Magnesium, B complex",None,None,,Sulfa drugs,"['Bone pain', 'Headache', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 932634,TX,41.0,F,"For the first few days, soreness, redness, heat, itching. After about 5-6 days the redness was completely gone and barely any itching. On day 11 it started itching again , the redness returned but worse this time. Extreme heat coming from it and the red area seems to be getting bigger. It is also swollen. There?s no hole that can be seen from the needle going in, just a huge red circle.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/08/2021,9.0,PHM,"Birth control (amethyst) Prevacid, lamictal, propranolol ER",None,None,,Sulfa,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 932635,IN,34.0,F,"At 6 hours after, I felt very dizzy and had a headache. At hour 12 I have a fever of 100.7, severe body aches, Hips, and knees were the worst. Paid scale would be 8/10. at 16 hours added fever was 102.5 , sever headache over the whole head, at hour 24 same. Hour 36 fever is down to 99.7 however, muscle paid have subsided and migraine is better. Pain scale 3/10",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/10/2021,2.0,PVT,"Klonopin .05 mg 1 and 1/2 daily, Celexa 20 mg, Phenergan 25mg 2x daily. Botox 200 MG injected every 12 weeks. , Emgality 120 injection 1x monthy. Baclofen 10mg 1-2 times daily. Benedryl 75mg 1x a day. Advil PM 1x daily.",Migraine,"brain injury caused by car accident 11/24/2004, chronic migraines. Also have a compromised immune system",,"Procardia, Tramadol, Morphine, all forms of steriods. Wheat. Allergy test on my back, stated it was allergic to everything except mice, dogs , cats and cockroaches.","['Dizziness', 'Headache', 'Migraine', 'Myalgia', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932637,VT,68.0,F,"Pain at injection site (resolved within 48 hours). Chills, lightheadedness, warm (not feverish), abdominal cramping, loose stool x 5 over 48 hours. Extreme fatigue (over 5 days)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Creon 24,000 Units Ursodiol 300 mg Vitamin D 2000 Units",None,None,,None,"['Abdominal pain', 'Chills', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Feeling hot', 'Injection site pain']",1,PFIZER\BIONTECH,IM 932638,IN,25.0,F,"I experienced muscle aches all over, my left arm where injection site located, was very sore. Had a low grade temperature of 99.7 (my temp is usually 97.1-97.3)and had really bad chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,Vraylar Synthroid Modafinil,None,Narcolepsy,,NKA,"['Chills', 'Myalgia', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932639,KS,54.0,F,"I woke up the next morning with fever, fatigue, aches and feeling faint. I didn't take my temperature, I went back to bed after taking Advil until I woke up at 2pm, then took Tylenol. By 4 pm I felt much better. My injection site was much more sore than the first dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Restatis eye drops, Estroven OTC, Flonase nasal spray, Ipatropium nasal spray",no,none,,"Sulfa, Augmentin","['Dizziness', 'Fatigue', 'Injection site pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932640,NC,47.0,F,"Vaccine administered 11:24 am on 1/6/2021. At approximately 11:30-11:31 patient notified this nurse that she ""felt funny"" and felt as if ""my jaw is tightening"" also that ""my throat is tightening"". Emergency protocol initiated: epipen administered x1dose to left thigh at 11:33am, EMS dispatched via 911, vital signs obtained. VS reported to EMS upon arrival at 11:37am. EMS assumed care of patient after report given and patient was transported to hospital at approximately 11:40 am.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PUB,"Unknown, denies prescription blood thinners",none reported,none reported,,"Sulfa drugs, oranges","['Feeling abnormal', 'Throat irritation', 'Throat tightness']",1,MODERNA,IM 932642,AZ,38.0,F,Around 3 am I woke up feeling very hot and nauseous followed by chills. I was so cold and shaky. The chills was the most bothersome part. It lasted about one hour and I feel fine now.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,Lexapro 10 mg Vitamin D,No,None,,None,"['Chills', 'Feeling of body temperature change', 'Nausea', 'Tremor']",1,MODERNA,SYR 932643,MD,29.0,F,Extreme fatigue and onset of headache 48 hours after vaccine was administered.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,PUB,"Oral contraceptives, Lexapro",,,,,"['Fatigue', 'Headache']",UNK,MODERNA, 932644,ME,34.0,F,Headache with accompanying nausea that has not resolved in almost a week,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,UNK,B12 injections monthly,None,None,,None,"['Headache', 'Nausea']",1,MODERNA,IM 932645,NC,57.0,F,"Painful arm 12/27/2020 Headache 12/28/2020 Low grade fever,severe headache, chills,nausea 01/06/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,PUB,HCTZ Nexium synthroid,None until got the vaccination pain where the injection site then day later started with headache then woke up on January 06 with chills low grade fever 99.8 and severe headache was told by work to go and get tested and stay home still waiting on results,"IBS,colitis, depression autoimmune disorder gastroparesis not diabetic",,"PCN , Sulfa, amoxicillin, athricmicen, sporins,eggs,codeine, keflex","['Chills', 'Headache', 'Nausea', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,SYR 932646,NJ,44.0,F,As soon as 3 seconds after the shot my right hand was numb and tingling. The tingling sensation is still there and I have chronic pain in my elbow running down my arm into my ring and pinkie finger.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,None,None,None,,None,"['Hypoaesthesia', 'Immediate post-injection reaction', 'Pain in extremity', 'Paraesthesia']",1,PFIZER\BIONTECH,SYR 932647,IN,35.0,F,"Fever tMax 103.9, myalgias, golf ball-sized axillary lymph node, migraine, nausea, shortness of breath.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Vyvanse 30mg qd,None,"PCOS, ADHD",,None,"['Dyspnoea', 'Lymphadenopathy', 'Migraine', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932648,FL,39.0,F,"My symptoms began approximately 14 hours after I received the vaccine. They started suddenly and included the following: -Intense dizziness that was also electric like and lasted 36 hours -Severe headache lasted 36 hours and mild for 48 hours -Fever last was intermittent for 48 hours. I only started recording it 24 hours after the vaccine was administered. My max temp was 101. -Nausea (1 episode of vomiting) lasted 36 hours -Muscle aches and joint pain lasted 36 hours -Extreme fatigue lasted 48 hours -Injection site pain and swelling are still present, but are now mild -Enlarged lymph node in armpit of the same arm that vaccine was administered. This was discovered about 24 hours after receiving the vaccine and is still present. It?s about 1 inch in diameter.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Paxil 20 mg QD Lamictal 150 mg BID Adderall 20 mg BID Vit D3 50 mcg QD,None,Bipolar Disorder Type 2 ADHD,,None,"['Arthralgia', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932649,PA,41.0,F,"Approximately 11hours after receiving vaccine on 1/8/21, terrible chills and shaking began. The next morning 1/9/21 around 6am temperature rose to 100.4F. At 3pm on that same day, temperature went up to 102.6F. Took Tylenol 1000mg at that time. Continued to have terrible shaking and chills, also experienced a severe headache, eye pain, and body aches. Had diarrhea once on 1/9. Fever broke this am on 1/10/21, still feeling slightly fatigued with discomfort behind my eyes but improving from yesterday.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"singulair, plaquenil, qvar inhaler",Covid-19 positive on 11/27/20,"asthma, follicular mucinosis (taking plaquenil)",,"penicillin, poultry, seafood","['Chills', 'Diarrhoea', 'Eye pain', 'Fatigue', 'Headache', 'Ocular discomfort', 'Pain', 'Pyrexia', 'Tremor']",1,MODERNA,IM 932650,ID,38.0,F,"In 13 days it has been a myriad of symptoms some. None are all the time. Many I?ve experienced several times. Within 48 hours, sore arm, diarrhea and rash on face and stomach. Symptoms since vaccine have included numb lips, fingers and tounge, headache, achy body, tightness in chest, dripping nose, sore throat.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,WRK,None,None,None,Flu shot 11/2020 and flu shot 2018,No know at this time,"['Chest discomfort', 'Diarrhoea', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Rash', 'Rhinorrhoea']",1,MODERNA,SYR 932651,IN,35.0,F,"On 1/9/21 I slept fitfully, woke up in a cold sweat but had a normal temp of 38.4. I had a headache, body aches, and nausea also. This was approx 16 hours post dose. I took 600mg of ibuprofen and felt more able to do normal home activities but still tired with a sore arm. 4.5 hours post ibuprofen dose I again had muscle aches, headache, fatigue, and nausea. I also had chills and joint pain. I napped for an hour, took another 600mg ibuprofen, and then napped for another 2.5 hours. After that I felt better at 27 hours post dose but still achy and fatigued. These symptoms had mostly resolved by 31 hours post dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Ibuprofen, prenatal multivitamin",None,None,,Sulfa,"['Arthralgia', 'Chills', 'Cold sweat', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Pain in extremity', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 932652,NY,30.0,F,"Chills, Fever (103.6), body aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 932653,IN,42.0,F,"Sore arm, cold chills, irritable skin all over, achy muscles, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,,,"Low fever, sore arm",,"['Chills', 'Feeling cold', 'Headache', 'Myalgia', 'Pain in extremity', 'Skin irritation']",2,PFIZER\BIONTECH,SYR 932654,,54.0,M,"Day 1 Nausea- 4 hrs after Swollen face/neck- 3 to 5 hrs- benadryl Left eye extreme blurry vision- 3 x's 2 to 5 min each Mental fog and confusion- 3 days intense, 4th day trouble with recall without intense focus Headache- 3 days intense, 4th day- moderate Elevated heartrate- sporadic first day until 6 pm Highly irritable- 2 days Incessant talking and moving",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,Amlodipine Valsartan,None,None,,NKA,"['Confusional state', 'Disturbance in attention', 'Feeling abnormal', 'Headache', 'Heart rate increased', 'Irritability', 'Logorrhoea', 'Nausea', 'Restlessness', 'Swelling', 'Swelling face', 'Vision blurred']",UNK,MODERNA,IM 932655,OH,38.0,F,"I felt fine after the shot all day. I went to bed at 1030pm, woke up at 1130 hyperventilating (respiratory rate was 40+ and I couldn?t lower it), shaking uncontrollably (felt increasingly cold, though my temp was normal; my skin was cold to the touch but I felt like it was burning off), tachycardic (heart rate was 140bpm and I normally am at 60-80 at rest). My throat felt like it was closing and my face was swollen. I should have gone to the ER, but I wasn?t thinking clearly and didn?t know what to do with my small children. It took 2 hours until I stopped shaking, my heart rate returned to normal, and my breathing was under control. Since then I have mainly been fatigued, taking Tylenol for overall aches, and have not been able to tolerate much activity (can only stand for about 5 minutes at a time).",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,Daily multivitamin and vitamin D,None,"Unknown immunodeficiency that resulted in significant hearing loss and need for bone anchored hearing aides. I have very sensitive skin and often get rashes for unknown reasons. Strong family history of celiac disease (brother, sister, and nephew have it).",,"Penicillin, vancomycin, all dissolvable sutures, gluten","['Decreased activity', 'Fatigue', 'Feeling cold', 'Hyperventilation', 'Oropharyngeal discomfort', 'Pain', 'Swelling face', 'Tachycardia', 'Tremor']",2,PFIZER\BIONTECH,IM 932656,TN,31.0,F,"Right after the second dose less than 2 minutes my heart rate began to spike. I could feel my heart pumping fast. I couldn?t sit due to this so I began pacing the room. I didn?t know this was a side affect so I thought I was over thinking the second dose. I attributed this to all the worry and doubt the media and people around me try pumping in your head. I thought I was having a panic attack. I didn?t alert any of the medical team there because again, I thought I was over thinking it. A few hours later my heart rate had gone down. My Apple Watch helped me monitor this. The next day I felt pain at the injection site, not my normal self, groggy. Slightly feverish and chilled. I work in a cold environment so I couldn?t quite tell if the chilled feeling was a side effect, or the room. Later that evening around 9pm things took a turn. I began running a low grade fever and was shaking from being so cold. About another hour late my fever was up to 101 and I was still shaking from being so cold. I took about 600mg of ibuprofen. I couldn?t sleep, tossed and turned. Probably another hour later my temperature was 102, still shaking uncontrollably. Covered in about 5 blankets I kept waiting it out. And I?d say around 2-3am I could feel my fever breaking. By late morning my temp was back to normal but I felt achy still. Tired, sore. Definitely sore at my injection site. And I don?t know if this is worth mentioning or not but just haven?t been able to shake that panic attack feeling. Like a worry or a dread over me. I just don?t feel as clear-headed as I did before. This is my biggest concern. Just don?t feel myself yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,"Low hormone birth control pill, Zyrtec, Flonase, multivitamin gummy.",Allergies.,None that I know of.,,Trimethoprim / Sulfamethoxazole(Bactrim).,"['Anxiety', 'Chills', 'Derealisation', 'Fatigue', 'Heart rate increased', 'Injection site pain', 'Pain', 'Palpitations', 'Poor quality sleep', 'Pyrexia', 'Somnolence', 'Tremor']",2,PFIZER\BIONTECH,IM 932657,VA,54.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Beginning the day of vaccine, very sore upper left arm for 2 days. Moderate headache beginning on day after vaccine, lasting for one day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,PVT,"Ramipril, metoprolol, atorvastatin, aspirin, vitamin D, famotidine",No,"Hypertension, hypercholesterolemia, cardiovascular disease (atherosclerosis)","Measles-~1992 fever, muscle aches, lethargy",Brillinta,"['Headache', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 932658,PR,56.0,F,"Raised, painful, erythematous and indurated injection site area with local increase in temperature, compatible with Arthus Reaction at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,WRK,None,None,History of Breast Carcinoma on Tamoxifen therapy,,No known allergies,"['Injection site induration', 'Injection site pain', 'Injection site reaction', 'Injection site swelling', 'Type III immune complex mediated reaction']",2,PFIZER\BIONTECH,IM 932659,TN,68.0,F,"On day 10 day post the injection, two red blotches, square or rectangular shaped, each about 1 cube inch, noted near the injection site , maybe just below as I could not see the actual injection site. It was hot and tender. Size extended by Day 11 slightly with the two squares becoming a more rounded single site. I took some Benedryl at that time about 4pm and then took Acetominophen and Famotidine at bedtime.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/09/2021,10.0,PUB,"Prilosec, Famitodine, Multivitamin, Allegra, Sudafed, Vit D, Vit B12, Align probiotics, Krill oil tablet, Vitamin for skin and nails",None,None,,"Dust mites, pollen, cats, grasses","['Injection site erythema', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 932660,AZ,30.0,F,"Sore arm at injection site 3hrs after given, at 8:30pm started to feel weak, became pale, started having all over body/muscle aches, chills, fever of 100� and nausea. Took some aspirin...helped a little bit but still only got around 4 hrs of sleep. Woke up still with sore arm, body aches, headache, and still weaker than normal. Took some more aspirin....it's been around 4hrs now and body aches and weakness are almost gone. Still have the sore arm and slight headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,None,Covid19 two weeks prior,None,,None,"['Asthenia', 'Chills', 'Injection site pain', 'Myalgia', 'Nausea', 'Pain', 'Pallor', 'Pyrexia', 'Sleep disorder']",1,MODERNA,SYR 932661,MD,25.0,F,"Pt. experienced mild itchiness under eyes and a ""tingle"" sensation in throat. Pt.'s skin color normal w/o any signs of a rash or swelling, no SOB, and no c/o nausea/vomiting. b/p 108/68, RR 20, pulse/HR 68 and regular with no arrhythmia. Pt states symptoms were much improved when she was leaving the post vaccination area. Pt. was discharged, ambulatory, and was was escorted out to vehicle (driven by her sister). Sister and pt. instructed to seek medical attention immediately should symptoms return.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,Unknown,Unknown,None,,Some fruit,"['Eye pruritus', 'Pharyngeal paraesthesia']",1,MODERNA,IM 932662,FL,65.0,M,No,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/10/2021,01/10/2021,0.0,OTH,"Losartan 100 mg, amlodipine 5 mg (daily) Atorvastatin 40 mg (daily)",hypertensive patient,,,,['Unevaluable event'],1,PFIZER\BIONTECH,IM 932663,NY,41.0,F,"Feeling fine in morning. Had cup of tea, went for vaccine at 10AM. Did fine with injection, sat down for observation, 8-10 minutes later started feeling sweaty, then passed out. Woke up on the floor with nurses around me feeling tightness in chest, numbness in fingers, body shaking off and on, started to feel like tongue was swelling. Nurses gave IV fluids, oxygen and 2 Epi-Pens. Transported by ambulance to Buffalo General Hospital. Symptoms resolved not long after arrival at hospital. Remained in EMT bay hallway for observation., seen there by ER doctor. Another EGK done, additional half bag of IV fluids, released after 4 hours observation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Vitamin D Midodrine HCL 5mg PRN,none,Hx neurocardiogenic syncope,,erythromycin - hives a a child,"['Blood glucose', 'Chest discomfort', 'Electrocardiogram', 'Hyperhidrosis', 'Hypoaesthesia', 'Loss of consciousness', 'Swollen tongue', 'Tremor']",1,MODERNA,UN 932664,IN,64.0,F,"Violent chills, headache, abdominal pain especially on the right side and vomiting. Muscular aches all over the body. Fatigue. 1/10/21: Still experiencing headache and muscle pain, occasional chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Atenolol 50 mg,IVP dye Lipitor,High cholesterol.,,,"['Abdominal pain', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pain', 'Vomiting']",1,PFIZER\BIONTECH,IM 932665,IN,52.0,F,1. Light headedness. Treated with extra fluids. Began 30 minutes after vaccine and lasted about 4 hours. 2. Fatigue and lethargy. Treated with rest and fluids. Began 24 hours after vaccine. Duration 12 hours. 3. Nasal congestion. No treatment necessary. Began 24 hours after vaccine. Duration 4 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,"Trintellix, Vyvanse, Levothyroxine, Liothyronine, Meloxicam, Levocetirizine, Montelukast, Estradiol, Progesterone, Testosterone, calcium, curcumin, Vitamin D3, Vitamin K2, MVI, Fish oil, Zinc with Copper, Magnesium glycinate,",None,"Asthma, Depression, ADD, Hypothyroidism, Post-menopausal","Loss of consciousness, early 30s, influenza",Sulfonamides,"['Dizziness', 'Fatigue', 'Lethargy', 'Nasal congestion']",1,PFIZER\BIONTECH,IM 932666,RI,81.0,M,patient in his usual state of health. Tested negative for Covid on 12/22/2020. Covid -19 vaccine-Pfizer-BioNTech administered on 12/28/2020. Patient tested for Covid-19 by swab on 1/8/2021. Result positive. Provider and staff at nursing home communicating regarding patient's condition and care via tele-health - telephone due to restrictions during Covid - 19.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/09/2021,12.0,SEN,"Advair, ASA, docusate, ferrous sulfate, lactulose, melatonin, Proair prn, propanolol, proscar, quetiapine, ramelteon, mirtazapine, multivitaoin, tamsulosin, bupropion,",patient hospitalized from 11/26/2020-12/8/2020 for acute mental status changes considered multi-factorial.,"advanced dementia, benign prostatic hypertrophy, remote history of MI and CAD, depression with psychotic features, history of positive RPR, constipation, asthma, history of abdominal pain with vomiting and GERD, protein calorie malnutrition, cirrhosis, ascites, CKD",,no known allergies to foods or medications,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 932667,NC,39.0,F,"Vaccine administered at 2:10 pm on 1/6/2021. Patient immediately stated that she ""feels warm all over"", then states that ""I am having an allergic reaction"". Emergency protocol initiated immediately, 911/EMS called. Patient heart rate in the 140's-150's. Patient refused epipen at this time due to no SOB. EMS arrived and patient states ""I feel better"". Patient refused transport to hospital and instead opted for calling her husband to come and get her. EMS waited with patient for approximately 15-20 minutes to ensure improvement. Patient monitored for next 45 minutes-60 minutes until husband arrived. Continued to improve. Left with husband.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,unknown,none reported,none reported,,Penicillen,"['Immediate post-injection reaction', 'Skin warm']",1,MODERNA,IM 932668,IL,55.0,M,SOB,Not Reported,,Not Reported,Yes,2.0,Not Reported,,01/07/2021,01/09/2021,2.0,OTH,Senna 8.6mg 2 tabs po Vit. D 1000 ui 2 tabs po Lactulose 30 cc BID,none,318.2 profound intellectual disability gingivitis 758.0 down syndrome 272.4 hyperlipidemia 564.00 chronic constipation vitamin D insufficiensy,,none,['Dyspnoea'],1,MODERNA,IM 932669,OK,67.0,M,"Injection was given very close to the shoulder joint in my left arm, as a result within a few hours a very sharp pain in my shoulder caused me to be unable to lift my left arm without extreme pain, not muscle pain. By 4:00 pm I was sapped of energy. During the night I developed chills and ran a fever of 100.4 F. By Sunday morning I felt nauseous, but did not vomit. At 2:00pm 12/10/2020 my fever has lowered and the nausea has subsided, but the shoulder joint is still very sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,OTH,Adderall 15mg / day Metformin 500mg / day,Covid-19 Positive test on 12/17/2020,Type 2 Diabetes,,Levequin Barley Peanuts Strawberries,"['Chills', 'Fatigue', 'Injected limb mobility decreased', 'Injection site pain', 'Nausea', 'Product administered at inappropriate site', 'Pyrexia']",1,MODERNA,IM 932670,IN,23.0,M,"Fever and chills, body aches, fatigue, headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Melatonin, Allegra",None.,Mild allergies.,,"Mild allergies to dust, cats, dogs, cockroaches, mold. No anaphylactic allergies.","['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 932671,WI,56.0,M,"I received Covid- 19 Moderna vaccine on 4 Jan 21. That night, I had muscle ache and diarrhea and went bathroom 3-4 times at night. Next day, I went bathroom about 5-6 times at work. Tuesday night, I felt chill, and then fever, and headache. So, I stayed home on Wednesday and Thursday in bed. I felt better on Friday, But, Yesterday and today, I am having fatigue and headaches. I took Nyquil and Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,"MULTI VITAMIN, VIT C, VIT D, MAGNESIUM.",,"HBP, SLEEP APNEA, PROSTATE, JOINT PAIN.",,,"['Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 932672,NY,19.0,F,"With in an hour of the vaccine, she had redness on the arm. It look like she was washing dishes. Her arm and hand were redder the right arm. No discomfort, no itchiness. It went away.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,WRK,unknown,unknown,unknown,,Latex/ NKDA,['Erythema'],1,MODERNA,SYR 932674,CA,43.0,F,"Client began having tightness in neck and face, tingling around mouth, and blotchy skin. Spoke with her primary, he suggested administering epi: 0.5 ml of 1mg:1000mL. Administered dose in R deltoid 30 minutes following vaccine administration, client began feeling better immediately.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,Unknown,None,No,,"Various allergies, but it is client and her provider have not determine causal factors.","['Facial discomfort', 'Muscle tightness', 'Paraesthesia oral', 'Rash macular']",7+,MODERNA,IM 932675,NY,38.0,F,"Received vaccine on 1/6 at 0800pm 1/7 - 730am woke up with a very soar arm, difficult to move. 10am felt very tired, like I was about to catch a cold. 12pm felt cold, had a temp of 99.9 F 3pm was very tired, chills, mild nausea, temp 100.8 F - took tylenol at this point 1000mg. Tylenol helped reduced fever and chills. Still continued to feel very tired and had no energy. Stomach continued to feel sensitive and had very little appetite. 10pm - fever returned 100.6 with chills - took another dose of 1000mg tylenol and went to sleep. Through out the night was hot and cold. 1/8 7am - I woke up had temp of 100.1F - no chills, still very tired, arm still very sore. Did not take tylenol. 9am - temp now 99.7 F - still very tired 10am - temp now 98.6F - nausea resolved, still had no appetite. Very tired, body felt sore and left armpit hurt when I moved, I noted no lymph nodes. Remainder of day I remained fever free, but continued to feel very tired and took a few naps. (this is not my norm, I do not nap). By dinner time appetite was better but stomach still felt tender. 1/9 - woke up feeling great, lots of energy, even went for a jog. Arm still a little sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,tylenol,none,psoriasis,,none,"['Abdominal discomfort', 'Asthenia', 'Axillary pain', 'Body temperature increased', 'Chills', 'Decreased appetite', 'Fatigue', 'Feeling cold', 'Feeling hot', 'Mobility decreased', 'Nausea', 'Pain', 'Pain in extremity', 'Tenderness']",2,PFIZER\BIONTECH,IM 932676,GA,26.0,M,"Numbness and tingling in left upper arm and chest wall that started 15 min after Moderna injection. Denies pain, weakness and shortness of breath.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/10/2021,0.0,MIL,None,None,Hemahromacytosis labs checked annually.,,Penicillin: rash was told as a toddler,"['Hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 932677,CT,25.0,F,Lasting from day of injection to approximately 48hrs after injection: Temp 99.9f Chills Ocular migraine Fatigue Body aches General malaise,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,"Zyrtec 10mg Singular 10mg Spironolactone 50mg BID Xolair 150mg injection q4 weeks Zoloft 100mg Mirena IUD Vitamin D3 2,000 IU",,Asthma Hereditary Angioedema Allergies,,Tree nuts Carrots Dust mites Pollen Mold/mildew,"['Body temperature increased', 'Chills', 'Fatigue', 'Malaise', 'Migraine with aura', 'Pain']",2,PFIZER\BIONTECH,IM 932678,NY,41.0,F,"My arm became swollen and sore to the touch at the injection site within the first hour. With in 2-3hrs my arm was so sore I could hardly lift it to shoulder height or rotate it. It was way more severe then I have ever felt from a standard vaxx or flu vaxx in years past. That continued for a full 48hrs, after that it subsided but was still sore around the injection site and the muscle. I was able to typically use the arm again with minimal pain. Around 14-16hrs after the injection I began to feel very achy and sick. My shoulders, neck and head hurt. I did not have a fever, but my skin all over my body was achy to the touch as well. I also found my self to he extremely tired, like feeling run down, around 12hrs after the shot (when I woke up). The ?fluish? feeling of a headache, feeling achy and being tired did get a little better but has continued into the 3rd day (today when I am reporting this).",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,No,No,No,,No,"['Arthralgia', 'Fatigue', 'Headache', 'Influenza like illness', 'Injected limb mobility decreased', 'Injection site pain', 'Injection site swelling', 'Joint range of motion decreased', 'Malaise', 'Musculoskeletal discomfort', 'Pain']",UNK,MODERNA, 932679,FL,56.0,M,"Very bad pain in injection arm, culls and sweats, sharp pain in right kidney area on and off.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Metformin 750xr Aspirin 81mg Lipitor 20mg Multi-vitamin,None,None,,None,"['Chills', 'Flank pain', 'Hyperhidrosis', 'Pain in extremity']",1,MODERNA,SYR 932680,NY,25.0,M,"Arm soreness started 12 hours later, malaise, chills, fever, headache, congestion started 24 hours later. 48 hours later only fever remains",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Chills', 'Headache', 'Malaise', 'Pain in extremity', 'Pyrexia', 'Respiratory tract congestion']",1,MODERNA,SYR 932681,IN,27.0,M,"Diffuse myalgia, mild non focal headache, low-grade fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,UNK,"Fish oil, creatine, Vitamin D",None,None,,None,"['Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932682,PA,24.0,F,"Fever 102.1, body aches, mild headache, nausea, fatigue Took Tylenol x2 Symptoms significantly improved and were almost completely resolved after 15 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Singulair,None,Asthma,,None,"['Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932683,MA,32.0,F,"Fatigue, tiredness/exhaustion, Right muscle pain, joint discomfort",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,,,,,,"['Fatigue', 'Musculoskeletal discomfort', 'Myalgia']",1,MODERNA,IM 932684,IN,48.0,F,"Severe body and muscles aches in both arms, shoulders, arms, back, hips and legs. Could not lift either arm above head. Skin was extremely sensitive to cold and touch. Heat and OTC pain reliever helped. Symptoms had improved within 24 hours but not fully. Some aches persist. I tested positive for Covid-19 in October 2020 and although my symptoms were very mild when I had the virus, my long lasting symptoms still persist (numbness and tingling in both arms, taste and smell come and go, fatigue continues, phantom smells of cigarette smoke, etc). I have also heard that symptoms can be worse for those that have had Covid before the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,WRK,"Losartan 100mg, Topiramate 25mg, Valacyclovir HCL 500mg, Phentermine 37.5mg, Hydrochlorothiazide 25mg, nexium, calcium chew, Aleve, Skin and Nails gummies., Zyrtec.",,High blood pressure,,,"['Hyperaesthesia', 'Mobility decreased', 'Myalgia', 'Pain']",UNK,MODERNA,IM 932685,WI,88.0,M,Resident received step one of Moderna Vaccine on 01/05/2021 which was within 14 days of receiving PPSV-23 on 12-26-2020 No adverse reactions observed within 48 hours after receiving vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,"Aspirin 325mg daily, Vitamin D3 (1000u) daily, Sertraline 50mg daily, Tylenol 1G BID, Senakot 8.6/50mg daily, Tamsulosin 0.4mg daily, Lisinopril 20mg daily, Tramadol 25mg daily. Received PPSV-23 on 12-26-2020",Left hip pathological fracture on 12-18-2020,"Hypertension, Renal Insufficiency, hx of prostate cancer, spinal stenosis",,NKA,"['Inappropriate schedule of product administration', 'No adverse event']",1,MODERNA,IM 932686,SC,46.0,F,"14 hours post vaccine began having tingling, pins and needles type sensations in feet, arms, hands, occasionally trunk",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,"Multivitamin, vit D, fish oil",None,None,,"Aspirin, ibuprofen, seasonal allergies such as pollen",['Paraesthesia'],1,PFIZER\BIONTECH,IM 932687,FL,75.0,F,Friday evening 1/8 - Saturday evening 1/9 Mild raised rash on upper inside lip. Saturday 1/9 Rash on chest above breast extending to shoulders. Very red raised on left side. Mild on right side and center. Put hydro cortisone otc cream on it. Sunday 1/10 Rash very faint. No treatment Today. Mouth better.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,OTH,Tylenol,None,None,,None,"['Cheilitis', 'Rash', 'Rash erythematous', 'Rash papular']",1,PFIZER\BIONTECH,SYR 932688,KY,42.0,F,I have had increased perspiration and constant itch/irritation under both of my armpits.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PUB,None,None,None,,None,"['Hyperhidrosis', 'Pruritus', 'Skin irritation']",1,MODERNA,SYR 932689,NY,52.0,F,"Sore arm, Tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,,,Diabetes,,,['Pain in extremity'],UNK,MODERNA,IM 932690,WA,47.0,F,"At 1700, felt malaise. .Woke up next morning on January 9th with 102 temp, 3cm lump at infection site, body aches, chills, headache. Still feeling poorly on January 10th.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,"Amlodpine , cyclobenzaprine, topiramate, upadacitinib",None,"Asthma, a fib, Migraine, osteoporosis, spondylosis",,"Aspirin, latex, egg and sulfa. Anaphylaxis hx for latex and aspirin","['Body temperature increased', 'Chills', 'Feeling abnormal', 'Headache', 'Injection site mass', 'Malaise', 'Pain']",2,PFIZER\BIONTECH,IM 932691,TX,36.0,F,"On December 30 I developed a sore arm along with a raised red rash at the injection site only. This last about 2-3 days and went away. Then on January 6 the red, raised rash at the injection site returned for approximately 2.5 days. The site felt slightly itchy like a mosquito bite. I reported it to my doctor who advised me to use Benadryl cream and/or benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PUB,"PPI, Pepcid, Zyrtec",Seasonal allergies,GERD,,Penicillin,"['Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Rash erythematous']",1,MODERNA,SYR 932692,IN,38.0,F,"Severe arm pain, swelling at injection site, redness, warm to touch. Feverish, chills, headache, diarrhea, severe body aches, joint pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,"Zoloft, trazodone",,,,Sodium benzonate,"['Arthralgia', 'Chills', 'Diarrhoea', 'Erythema', 'Headache', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932693,IN,38.0,F,"Fatigue, body aches, arm pain, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Multivitamin,None,None,,None,"['Chills', 'Fatigue', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 932694,TX,33.0,F,Fever. Chills. Dizziness. Vomiting. Cramping,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,UNK,Lexapro- 5mg Lo estrin,,,,None,"['Chills', 'Dizziness', 'Muscle spasms', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,SYR 932695,CA,38.0,F,"Pain at injection site and numbness, tingling, and weakness to 4th and 5th digits of left arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,Acyclovir,Cold sore,,,"Bactrim, cephalexin","['Hypoaesthesia', 'Injection site pain', 'Muscular weakness', 'Paraesthesia']",1,MODERNA,IM 932696,IL,26.0,M,Nausea/vomiting and diarrhea loss of appetite tachicardia sent to er for hydration.,Not Reported,,Not Reported,Yes,,Not Reported,N,01/07/2021,01/08/2021,1.0,SEN,"Keppra,colase,miralax, erythromycin, acidophilus",no,"CP, seizure disorder",,"Gluten, lactose intolerance","['Decreased appetite', 'Dehydration', 'Diarrhoea', 'Nausea', 'Tachycardia', 'Vomiting']",1,MODERNA,IM 932697,OH,38.0,F,"headache for a few hours after injection, mild nausea, constipation starting 1/8/2021 and still continuing",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"b complex, vitamin c, magnesium",none,none,,pcn,"['Constipation', 'Headache', 'Nausea']",1,MODERNA,IM 932699,CA,32.0,F,"Injection site: pain, tenderness, soreness - still present General side effects: Dizziness -10/08/2021 3 hrs Weakness - still present Chest pain - 10/08/2021 2hrs Difficulty breathing - 10/08/2021 2hrs Chills -still present Muscle pain - still present Joint pain -still present Fever - 10/08/2021 1130pm Chest sore - still present Muscle stiffness - 10/10/2021 1130am",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,Pepcid Zyrtec Albuterol,None,Asthma,,None,"['Arthralgia', 'Asthenia', 'Blood glucose', 'Chest pain', 'Chills', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Injection site pain', 'Musculoskeletal stiffness', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 932700,FL,67.0,F,Minor pain in arm starting about 10 hours after vaccination and ending by 3rd day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,OTH,"Metformin HE 500MG, Spironolactone 25mg, Metoprolol 50mg",none,,,"Lotrel medication, anaphylactic reaction",['Pain in extremity'],1,PFIZER\BIONTECH,SYR 932701,IL,27.0,F,"24 hours after the 2nd vaccine on 1/7/21, I began experiencing joint pain in bilateral hands, fingers, thumbs. Worsened over the next few days. Created difficulties with grip. Took ibuprofen, and applied heat/ice. General fatigue as well. Still recovering as of today 1/10/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Effexor, Wellbutrin, baby aspirin, Singulair, Allegra, vitamin D3, vitamin B12, probiotic, spirulina, women?s multivitamin","Mononucleosis from 10/27-11/27. First Pfizer vaccine on 12/17, second on 1/7","Depression, Generalized Anxiety Disorder",,"Ceclor, Sudafed, seasonal, pet dander","['Arthralgia', 'Fatigue', 'Grip strength decreased']",2,PFIZER\BIONTECH,IM 932702,MN,63.0,F,"I immediately felt dizzy, and there was ringing in my ears, I felt faint. I also felt shakey. I have had these symptoms for 12 days, unchanged. I cannot work because of these symptoms. I have been to urgent care and have had lab work and an EKG",Not Reported,,Not Reported,Not Reported,,Yes,N,12/30/2020,12/30/2020,0.0,PVT,Multi vitamen,None,None,,None known,"['Dizziness', 'Electrocardiogram normal', 'Full blood count normal', 'Immediate post-injection reaction', 'Impaired work ability', 'Metabolic function test normal', 'Tinnitus', 'Tremor']",1,PFIZER\BIONTECH,IM 932703,KS,42.0,F,"Injection site is very red, sore, and has a very large bump. Pain spread to armpit area which is enlarged and bumpy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,Wellbutrin XL 300 Lamictal 150,None,Bipolar Depression and Anxiety,,"Milk, and neosporin","['Axillary pain', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy', 'Oedema peripheral']",2,PFIZER\BIONTECH,IM 932705,OH,20.0,F,Throat tickle progressing to difficulty breathing within 10 mins of administration,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,OTH,"Adderall 10 mg, hydroxyzine, epinephrine",none,none,,"coconut, grass, dander, pumpkin, pollen, amoxicillin, penicillin (& Pfizer Covid-19 vaccine after today)","['Dyspnoea', 'Throat irritation']",1,PFIZER\BIONTECH,IM 932706,OH,24.0,F,"Pain in right arm, neck, and back. Fever and chills. Hot tingly feet. From 2:00am-3:00pm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,OTH,Zyrtec,None,None,,Sulfa,"['Back pain', 'Chills', 'Feeling hot', 'Neck pain', 'Pain in extremity', 'Paraesthesia', 'Pyrexia']",1,MODERNA,SYR 932707,FL,71.0,F,"On 10th day after vacine, arm is swollen (3 inch square area) hot and aching. Noticed it about 11:00 this morning",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/10/2021,8.0,PVT,"Biest (hormone replacement compound) Standard Process supplements - Min-Chex, Gastrex, Multizyme Hypertine (Chinese Medicine)",none,none,,none,"['Pain', 'Peripheral swelling', 'Skin warm']",2,MODERNA, 932709,TX,18.0,U,"PATIENT FELT COLD (CHILLS) ,. PATIENT REFUSED EMERGENCY SERVICES AND/ OR TO CONTACT A DOCTOR.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,,,,,"pickles, cheese, sulfa drugs","['Chills', 'Feeling cold']",1,PFIZER\BIONTECH,IM 932711,WA,47.0,F,"Pt stated about 10 mins after administration she had itching in her arms, Waited 5 min then requested Benadryl. Redness on face and arms. 25 mg's of Benadryl given at 10:28AM. Caregiver discarded to home at 11:15 am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,,,,,"Oxycodone, Dilaudid","['Erythema', 'Pruritus']",2,PFIZER\BIONTECH,IM 932712,CT,37.0,F,"Late localized reaction. Redness, pain, itching, hot to the touch. Redness is about 6? long and about 5? wide. Reaction started at vaccine site 9 days after vaccine administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/09/2021,10.0,WRK,,,,,,"['Erythema', 'Local reaction', 'Pain', 'Pruritus', 'Skin warm', 'Vaccination site reaction']",1,MODERNA,IM 932713,MT,62.0,F,"About 13 hours after injection I started having extreme chills and shaking. Took 2 Ibuprofen and the chills subsided during the night and then had mild/moderate body aches for about another 12 hours. About 48 hours after the injection the top half of my arm is currently slightly swollen, red and hot to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,"Krill oil, Fiber, Multi Vitamin, Grape Seed Resveratrol, Hair Skin & Nails, Calcium",None,Hairy Cell Leukemia - In remission for 16 years.,,None,"['Chills', 'Erythema', 'Pain', 'Peripheral swelling', 'Skin warm', 'Tremor']",2,PFIZER\BIONTECH,IM 932714,NM,23.0,F,"Approximately 1 hour after receiving the vaccine I developed tachycardia that ranged between 130 and 95, this lasted from 01/08/2021 until 01/09 ~10 AM. On 01/08 ~5 PM I began to develop a fever that reached a peak of 102.4 at 4am (01/09), despite taking 1000 mg of acetaminophen every 6 hours. Last fever recorded 01/09 ~9PM of 99.5 (while still taking 1000 mg of acetaminophen every 6 hours). Additional symptoms have been severe nausea, dizziness, lightheadedness, bilateral lower back pain with some mild bruising to the kidney region, difficulty breathing, chest pressure, shortness of breath along with a cough upon exertion (developed ~6 PM 01/08), which is still present today (01/10 1:25 PM), and an erythematous rash that covers the anterior side of the right forearm, from wrist to elbow (first noticed on 01/10 ~11 AM).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,UNK,Midodrine (5mg x3 per day),None,Hypotension,,None,"['Back pain', 'Chest discomfort', 'Cough', 'Dizziness', 'Dyspnoea', 'Nausea', 'Pyrexia', 'Rash', 'Rash erythematous', 'Skin disorder', 'Tachycardia']",2,PFIZER\BIONTECH,SYR 932715,WI,34.0,F,"I had headache, joint and body aches. The the night of the 2nd vaccination, I was awoken to what felt like electrical jolts in my body. One time I woke up jumping so high of my bed that it felt like I was being tased. I woke up the next morning and felt like electrical currents were running through my body. My right hand had a tremor too",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Depo birth control injection, Emgality injection, adderall, multivitamin, fluoxetine",No,"Had a moderate case of Covid on 11/04/2020. Obesity, depression, ADHD, OCD, anxiety, migraines (brain surgery on 08/2011)",,,"['Arthralgia', 'Electric shock sensation', 'Headache', 'Pain', 'Tremor']",2,PFIZER\BIONTECH,SYR 932716,NJ,24.0,F,"About 10-15 minutes after shot, I developed a large red splotchy rash on my chest and it started spreading up my neck and face. I also felt dizzy, a little numbness and tingling and very cold/ shaky. I was given a total of 50 mg of Benadryl PO. 25 mg immediately and then an additional 25 mg about 30 minutes later. About 15 minutes after my second dose of Benadryl my rash started to subside and I began feeling better. ADTER about an hour I felt back to my baseline.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Oral contraceptive pill,None,None,,None,"['Dizziness', 'Feeling cold', 'Hypoaesthesia', 'Paraesthesia', 'Rash', 'Rash erythematous', 'Tremor']",2,PFIZER\BIONTECH,IM 932717,NV,38.0,F,I felt weak and with muscle fatigue the day after the shot. Also had a headache and neck muscle tension and mid back muscle tension. Joint pains as well. These subsided after 48 hours except for the neck and upper back muscle fatigue and mild soreness. This gave me a low grade headaches almost daily since the vaccine. I took ibuprofen a few times which helped. On the 6th I awoke at night and felt weak all over. I felt like I was falling in my bed. Mild dizziness. I went to work and felt extremely fatigued with muscle weakness but no neuro deficits. I feared some terrible autoimmune illness and took Decadron that day- 4mg tab BID. This helped my muscle weakness but left me with insomnia. The decadron is now wearing off after 4 days and I still have muscle weakness/fatigue. It takes considerable effort walking up the stairs. Yesterday my masseter muscles became fatigued with little chewing. My arms feel heavy when I lift them. The strange thing is that at night when I lie down I feel like my sympathetic nervous system is being triggered. I will get palpitations and feel just strange- I can't describe it. I took valium to sleep last night -5 mg tablets that my doctor gave me Saturday as there seems to be an anxiety panic component going on. I have no history of diagnosed anxiety or panic attacks- I have never felt this way before. Today I feel a little better but still have considerable muscle fatigue and neck and upper back muscle soreness and overall muscle tightness in my arms and legs- feels good to stretch kind of feeling. I have mild dizziness when standing up and turning too abruptly. But no considerable focal neuro deficits.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/06/2021,15.0,PVT,Zinc. Vitamin C. Echinacea.,None,None,,Sulfa allergy- rash only,"['Anxiety', 'Arthralgia', 'Asthenia', 'Back pain', 'Dizziness', 'Dizziness postural', 'Fatigue', 'Feeling abnormal', 'Gait disturbance', 'Headache', 'Insomnia', 'Limb discomfort', 'Mastication disorder', 'Muscle fatigue', 'Muscle tightness', 'Muscular weakness', 'Neck pain', 'Palpitations', 'Panic attack']",1,PFIZER\BIONTECH,IM 932718,PA,64.0,F,Patient reported feeling warm and flushed. No obvious rash or redness. Given Benadrly po and observed by paramedic onsite for an additional 30 minutes. The patient felt better and requested to go home. Family member present to drive her home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,,,,,,"['Feeling hot', 'Flushing']",1,MODERNA,IM 932719,CA,51.0,F,"1st vaccine dec 18th : arm pain for 3 days , felt sick within 2 hours with headache and fever and chills temp at that time 100 degrees , : fever 100 to 101 degrees on day 1 , 2 , 3 , 100 degrees on day 4 , day 5 , myalgia , body aches and headaches daily week 1 and fatigue week 2 was bed bound for 2 days and then could not work for 3 days after that 2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of injection with burning , pain and tingling , headache and feverish feeling and chills started within 2 hours , severe myalgia and body ache and headache day 1 and day 2 , on round the clock tyelenol every 6 hours , temp max recorded 100.6",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/18/2020,0.0,WRK,none,none,none,,none,"['Burning sensation', 'Chills', 'Fatigue', 'Headache', 'Impaired work ability', 'Malaise', 'Myalgia', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Pyrexia']",,PFIZER\BIONTECH,IM 932720,CT,31.0,F,Headache - 10 hours after receiving lasted a couple hours subsided with ibuprofen Fever- highest 101.3 on 1/9/2021- had fever/chills from 1/8/2021-1/9/2021- subsided with ibuprofen but would come back up after several hours. Nausea- started 1/8/2021 through 1/10/2021 Vomiting- started 1/8/2021 through 1/10/2021- not able to keep any foods/ drinks down with the exception of water. Tried BRAT foods and still vomited within 10-15 mins of eating.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,-Marlissa (birth control pill) -Ajovy (fremanezumab-vfrm) injection,None,Migraines (without aura),,None,"['Appetite disorder', 'Chills', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 932721,IN,40.0,F,"Woke up this morning with swollen, and extremely tender right armpit area. It is visually swollen compared to the left and is very painful. I am under the assumption this is likely a swollen lymph node post second vaccination. I have taken ibuprofen in attempt to help with pain and inflammation but does not seem to be helping much at this time. I anticipate this will improve over time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/10/2021,2.0,PVT,,,,,,"['Axillary pain', 'Lymphadenopathy', 'Tenderness']",2,PFIZER\BIONTECH,IM 932722,OR,60.0,F,"nothing for 2 days then onset rash and itching on fingers Between joints- worse every day spreading to wrists and more like hives. then spread to MCP joints. Both knees red but not hives. small petechiae on anterior lower legs, thighs and upper arms. a few erythematous areas on chest wall , ears red and itchy. no respiratory problems , no headache or joint aches at all. lasted for 1 week did not respond to topical creams . resolved spontaneously on day 7",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/02/2021,2.0,PVT,"calcium Vit D3, Premarin progesterone",none,none,,None,"['Erythema', 'Petechiae', 'Pruritus', 'Rash']",1,MODERNA,IM 932724,TX,44.0,F,Asthma attack and fever.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,Asthma medication (Breo),Asthma,Asthma,,NKA,"['Asthma', 'Pyrexia']",1,MODERNA,SYR 932725,FL,59.0,F,7 days after I received the vaccination I developed a raised rash under the area where I received the injection. Over the course of the day it got worse and my hand started to tingle. I called our Occupational Health Director and was instructed to take Benadryl and Advil and use a cold compress . I went home and did all those things in addition I took a 100mg Doxycycline that night and the next morning. The next day the rash area was not raised but the redness and itching was going down toward the elbow. By the second day on the same treatment my rash area was almost resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/07/2021,8.0,PVT,"Turmeric, Calcium, Vitamin D",None,Osteoporosis,,None,"['Erythema', 'Injection site rash', 'Injection site swelling', 'Paraesthesia', 'Pruritus']",1,MODERNA,IM 932726,TX,41.0,F,"HEADACHE, LIGHTHEADED, BODYACHES, LITTLE NUMBNESS IN THE RIGHT CHEEK B/P 152/93 PULSE 96 @ 12:55PM PATIENT STATED SHE IS NOT GETTING WORSE @1:26PM PATIENT REFUSED EMERGENCY SERVICES AND/ OR CALLING MD",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,,,,,BEES,"['Dizziness', 'Headache', 'Hypoaesthesia', 'Pain']",1,PFIZER\BIONTECH,IM 932727,PA,65.0,F,"2 days after injection, nausea, projectile vomiting, 1 episode of unwitnessed syncope",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,UNK,Estrace,None,None,Shingles,None,"['Nausea', 'Syncope', 'Vomiting projectile']",1,PFIZER\BIONTECH,IM 932728,TN,26.0,M,Uncontrollable shaking at 2:00 am the following morning after the vaccine. Shaking lasted about an hour and from 3:00am to 6:00am hot flashes and body aches. Temperature was 100 degrees.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,,,UNK,Sertraline 50mg once daily,None,None,,,"['Body temperature increased', 'Hot flush', 'Pain', 'Tremor']",2,PFIZER\BIONTECH,SYR 932729,MN,43.0,F,"Received vaccine on 1/4. Started with hives on 1/6 am. Facial swelling on 1/7. Has been taking Benadryl 50 mg at night since 1/6. Facial swelling continues. Hives reduced, but redness continues.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/13/2021,9.0,PVT,1. Metformin 500- 1000 mg 2. Pravastatin 0- 20 mg 3. Vit D3 5000 iu 4. Minoxidil Topical Foam for Hair growth,None,Type 2 DM HLD,,Ciprofloxacin,"['Erythema', 'Swelling face', 'Urticaria']",1,PFIZER\BIONTECH,IM 932730,CA,57.0,M,"Woke on the morning of 1/10/21 (about 30 hours after injection). Temp to 100.6F, mild chills, major joints ache, dry cough, runny nose/eyes. Felt a bit better after Motrin400mg, but symptoms returned, although now worse the original presentation so far.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/10/2021,1.0,PVT,"aspirin, plavix, HCTZ, amlodipine, glucophage, lipitor, lisinopril, zyrtec, sertraline, glipizide, genvoya",none,"HTN, diabetes, HIV, arthritis",,none,"['Arthralgia', 'Body temperature increased', 'Chills', 'Cough', 'Lacrimation increased', 'Rhinorrhoea', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,IM 932732,MN,31.0,F,"Fever, chills, severe headache, extremely swollen lymph node under armpit of the arm vaccinated",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,Levothyroxine Biotin,None,None,,Latex,"['Chills', 'Headache', 'Lymphadenopathy', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932734,IN,41.0,F,"Severe muscle aches (all throughout body), chills, feverish, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Fluoxetine, Zinc, Vitamin C, Elderberry",None,None,,None,"['Chills', 'Fatigue', 'Myalgia', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932735,NC,39.0,F,"Swelling in underarm on left side wher shot administered. Lasted less than 24 hours. Congestion and tenderserness day 3-4, just over",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Lisinporil 40 Xyzal,Had what appeared to be pink eye starting on 1/4/21 but symptoms gone before vaccination,High bp,,Multiple,"['Lymphadenopathy', 'Respiratory tract congestion', 'Tenderness']",2,PFIZER\BIONTECH,SYR 932736,IN,42.0,F,"Woke the morning of Friday, January 8th, 2021 with a slight cough, heaviness to my chest, and extreme fatigue. Had to use my inhaler twice, get rest, and plenty of hydration for 24 hours then felt fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Topamax, Zyrtec, Metformin, LDN, Zoloft, Ozempic, Armour Vitamin C, Vitamin, D, Magnesium, Probiotic, Cranberry, Iron, Thyroid Supplement, Immune Support",Everyday Allergies,"Insulin Resistance, Migraines, Thyroid Nodules, Anxiety, and Allergies",Flu Vaccine,"ASA, Ceftin, NSAID's","['Chest discomfort', 'Cough', 'Fatigue', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 932737,CA,51.0,F,"2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of injection with burning , pain and tingling , headache and feverish feeling and chills started within 2 hours , severe myalgia and body ache and headache day 1 and day 2 , on round the clock tyelenol every 6 hours , temp max recorded 100.6",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,none,none,none,,none,"['Burning sensation', 'Chills', 'Headache', 'Myalgia', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932739,CA,28.0,F,"1/8/21 at 0830 sore arm 1/9/21 at 0200 chills 0800 fever, muscle aches, fatigue 1/10/21 at 1000 Fever resolved. Fatigue and muscle aches still noted",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,WRK,Tylenol,N/a,Asthma,,N/a,"['Chills', 'Fatigue', 'Myalgia', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932740,PA,60.0,F,"1-8-2021: 9:25 body shaking, nostrils constricting, throat tightening and legs weak. Happen while I was heading home. Returned to HD. EMT administered 50ml benedryl and pushed 125ml saline. No response. Throat felt tight, not closed but tight. Offered EpiPen .3 agreed. Body reaction - shaking. Went to Hospital ER via ambulance (~11am). ER administered 50mg steroid and had 2 puffs of albuterol inhaler twice. Became very tired but felt heart raced - assumed reaction to steroid/albuterol. 2:30pm started to finally feel relief. Discharged 4pm with rx for prednisone 50mg 1/day-10 days and benedryl 25mg for that night and am/pm next day. O2 dropped to 94 that evening. Administered 3 rounds of 2 liters/minute before saturation held at 97. 1-9-2021: 9am took benedryl and prednisone doses. 10am both nostrils still feel ""swollen,"" legs are weak and very tired (benedryl?). Oxygen saturation is good - 97. Starting to feel slight sensitivity at injection site. 4pm able to shower and move around. Breathing is better. Elected not to take benedryl as I'm not getting an positive response from it, only fatigue. Nostrils still feel swollen - tried lubricated nasal spray, not much help. 1-10-2021: 8:30 prednisone dose Oxygen saturation good - 98% pulse 72. Nostrils still feel swollen. Injected site sore, Started around 4pm (similar to shingles vaccine - expected).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,"Multi vitamin, fish oil 1000mg, pure CBD oil",None,None,,Ceftin,"['Fatigue', 'Muscular weakness', 'Nasal congestion', 'Throat tightness', 'Tremor']",1,MODERNA,IM 932742,IL,29.0,F,"Lightheadedness, mental status changes (foggy) with difficulty focusing",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,Unknown,None,None known,,NKA,"['Disturbance in attention', 'Dizziness', 'Feeling abnormal', 'Mental status changes']",1,PFIZER\BIONTECH,IM 932743,IL,58.0,F,"Covid19 second vaccination dose at 1030am 1/8/21 into L arm, which became more sore and faster than the first dose. Tired in evening so went to bed early. Around 2100pm chilling/fever began lasting about 5 hours. This was associated with headache, nausea, and arthralgias. No sleep. All day on 1/9/21 very lightheaded, headache, and some nausea. Spent the day lying on the couch. On 1/10/21 while headache still there in am, much improved. Still some uneasiness of stomach. L axillary soreness. Over all feel much better though not fully normal on afternoon of 1/10/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,"aleve, certrizine",None,None,,sulfa,"['Abdominal discomfort', 'Arthralgia', 'Axillary pain', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Insomnia', 'Nausea', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932745,AZ,64.0,F,"the morning after the vaccine, I had a episode of blurred vision which lasted between 1-2 minutes. I was laying in bed,just awoke and opened my eyes when this occurred. the blurring was as if the room was shaking and blinking my eyes did not clear ir. I closed my eyes for a minute then my vision returned to normal. i have never experience this before or since .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"lantus and humalog insulin, paxil, lisinopril, statin, biotin 1600mg , melatonin 3mg,rantididine",type 1 dm,as above,,"aureomycin,diflucan",['Vision blurred'],2,MODERNA,IM 932746,TX,49.0,F,"1st & 2nd day extreme /Joint & musculoskeletal pain, head ache, fatigue , short of breath, Coughing, runny nose, congestion, fever, ringing in ears, 3rd day musculoskeletal & joint pain, inner ear pain, fatigue, cough, throat pain This is 3rd day and I am still miserable",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Gabapentin, Cymbalta, Quetipine, Zanaflex",,"Migraine headaches, IBS",,,"['Arthralgia', 'Cough', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Headache', 'Musculoskeletal pain', 'Oropharyngeal pain', 'Pyrexia', 'Respiratory tract congestion', 'Rhinorrhoea', 'Tinnitus']",2,PFIZER\BIONTECH,SYR 932747,OH,47.0,M,"Received shot Weds @ 1400. Within 2 hrs I had a low grade temp. Within 4 hrs I became achy and sluggish, with a small HA. Next morning I felt ok, just achy. By 1400 I?m sluggish, very achy, and a migraine. Sat was a repeat of Fri. Today, same thing. All I do is sleep and hurt all over, including a migraine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,Celexa QAM Gabbapentin QPM,None,Migraine,,Codeine,"['Body temperature abnormal', 'Headache', 'Migraine', 'Pain', 'Sluggishness', 'Somnolence']",1,MODERNA,IM 932748,IN,20.0,F,"Fever, chills, malaise, body aches, nausea, headache, all lasting 24 hours. Treated with NSAIDs, resolved after 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Malaise', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932749,TX,60.0,F,HEADACHE (MIGRAINE) 8/10 . PATEINT REFUSED EMERGENCY SERVICES AND/OR CALL MD B/P 141/94 PR 64 @11:35 PM B/P 185/98 PR 60 @11:45 NO N/V NO CHEAT PAIN,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,,HIGH BLOOD PRESSURE,HIGH BLOOD PRESSURE,,,"['Headache', 'Migraine']",1,PFIZER\BIONTECH,IM 932750,CA,61.0,M,headache ringing in ears and light sensitivity and one week later redness swelling and itching at injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,none,none,none,,PPD,"['Headache', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Photophobia', 'Tinnitus']",1,MODERNA,IM 932751,IN,91.0,F,"funny feeling in left head, increased saliva in mouth, tongue burning",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,"synthroid, atorvastatin, cilostazol, wellbutrin, norvasc, lantansprost, timolol, oxycodone, prozac, asa, multivitamin, co q-10, stool softener, cosamin, calcium, vitamin d",none,over age 65 and chronic kidney disease,,"lortab, allegra, cefdinal, inderal, amoxicillin, flagyl, erythromycin, lasix, ibuprofen, bactrim, doxycylcine, steroids, nitrates, iodine, bromide, cipro, martazapine, nsaids, morphine, diflucan, gabapenti, clonidine, catapres, pepcide, tizanadine","['Feeling abnormal', 'Salivary hypersecretion', 'Tongue discomfort']",1,MODERNA,IM 932752,GA,31.0,F,"Developed a red itchy small circle (quarter size) at injection site about 4-5 hours after injection. Lasted day of and day after. It was gone on the third day. A week and a day after injection the itchy red circle appeared in larger size and more defined circle. Disappeared the next day. On day 12 after injection the rash had expanded to almost half my arm. It was a bit itchy at times and this time it was not circular, instead irregular shape with defined square like borders on one end. It lasted 2 days, disappeared and hasn?t come back yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,UNK,,,,,,"['Injection site reaction', 'Rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 932755,FL,44.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Chills (low temp), fever (102), bad headache, overall body aches, fatigue. Taking Tylenol and Aleve around the clock. Still ongoing.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,"Tylenol, Aleve",Unknown,Mild occasional asthma,,None,"['Fatigue', 'Feeling cold', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932756,MS,38.0,F,"On January 6, 2021, 7 days after receiving the vaccine, I developed shortness of breath and increased heart rate that lasted briefly, followed by numbness of left arm (where I received vaccination). I was evaluated by the emergency room. Numbness to left-arm last 6 hours. During this time, I developed tingling to the tip of my tongue and tingling to lips. Later, I developed tingling to fingers and toes. The following day, the palms of my hands were tingling and turned red then a bluish discoloration. I have has extreme fatigue for 4 days starting on January 6th. Also, on the day of the vaccine December 30th, I had pain at the injection site immediately in addition to redness and swelling that lasted 3 days. On January 10, I have developed a headache. I no longer have numbness but have cold sensitivity and tingling in fingers.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,Vitamin D Vitamin C Ibuprofen as needed Psyllium Husk,None,Hx of Afib,,None,"['Blood glucose', 'Blood thyroid stimulating hormone', 'Dyspnoea', 'Electrocardiogram normal', 'Erythema', 'Fatigue', 'Full blood count', 'Headache', 'Heart rate increased', 'Hypoaesthesia', 'Immediate post-injection reaction', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Lipids', 'Paraesthesia', 'Paraesthesia oral', 'SARS-CoV-2 test negative', 'Skin discolouration']",1,MODERNA,IM 932757,IN,50.0,M,"Severe fatigue, malaise, myalgia which lasted for 18 hours Ibuprofen helped significantly reduce the symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Lopressor, aspirin, Pepcid",None,None,,None,"['Fatigue', 'Myalgia']",2,PFIZER\BIONTECH,IM 932758,IL,28.0,F,Redness starting from injection sight going out word that has worsened since getting vaccine 2inches by 3inches wide approximately now,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PUB,Effexor Levothyroxin Propisal Buspar Metformin Zofran,,Deviated septum Hoshimotos Headaches,,Latex,['Injection site erythema'],UNK,MODERNA,SYR 932759,IL,53.0,M,"Headache, chills, fever (101), chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,"Lisinopril, Chlorthalidone, Rosuvastatin, Bupropion, Nexium, Metformin, Potassium Citrate, Xyzal",,HTN,,,"['Chills', 'Fatigue', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932760,MI,36.0,F,"Fever of 102 degrees, chills, headache, muscle aches, fatigue, sore arm. Sore arm mild night of injection, severe and with back pain upon waking on 1/5. By noon of 1/5, had all symptoms listed above. Continued worsening until I took Motrin 400 mg at 6:00pm. Symptoms improved significantly within 30 minutes, fever resolved. Body aches and sore arm persisted at mild levels for a few days but resolved by 1/8.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,WRK,,,,,,"['Back pain', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 932761,MI,38.0,F,"I got it at 2pm Friday. About 2 hours later my arm started feeling sore but not too bad. I did some light yoga and walked on the treadmill for 40 minutes. Otherwise took it easy that day. Satu I woke up with a slight headache which isn't unusual for me. I still had mild soreness in my arm. I did a more difficult yoga workout and then walked 5 miles outside. Took a shower after and relaxed for a bit. Then had dinner around 5 and within the hour started having diarrhea. This lasted a few hours during which my arm started gradually hurting more, it was pretty bad. Could barely move it and hurt to the touch even. Shivering started soon after. I never had a fever or fatigue during all of this. Highest temp was 98.4 with forehead thermometer. I talked to a doctor to put my mind at ease and he said I was having a big immune response to the vaccine, apparently younger adults between 20 to 40 are having bigger immune responses. The second dose is stronger so most are having these symptoms after that one, but some are having it after the first as well. He also told me I should have taken it easy these past 2 days and that I likely overdid it. He advised that I take motrin or Tylenol, get under blankets to stay warm, and rest. That's exactly what I did and a little over an hour later I was feeling much better. I'm a bit freaked out by what the second dose is going to do to me since it is supposed to be worse. Is it safe for me to get second dose?",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PHM,Tricycles lo Spironolactone,None,None,,Minocycline -serum sickness reaction,"['Anxiety', 'Chills', 'Diarrhoea', 'Headache', 'Immunisation reaction', 'Mobility decreased', 'Pain in extremity', 'Tenderness']",1,MODERNA, 932763,NY,53.0,F,"Within 5 minutes of getting the vaccine I started to feel itchy on my face, hands, arms, back and stomach. My face got hot, red and blotchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,"Allopurinol 100mg oral tablet hydroCHLOROthazide 25mg oral tablet metFORMIN 500mg oral tablet methenamine hippurate 1g oral tablet metoprolol succinate 25mg oral tablet, extended release potassium citrate Er tabs 100's 10meq Synthroid 175",,Thyroid cancer Type 2 diabetes,,Macrobid Sulfur adhesive,"['Erythema', 'Feeling hot', 'Pruritus', 'Rash macular']",1,MODERNA,SYR 932764,IN,42.0,M,"Start to not feel well around 4:00 pm. Had a headache and runny nose and a fever of 99.8. At est 8:45, fever was 100.2, still headache and runny nose and little body aches Felt like a head cold. Was tired also. I took ibuprofen and fell asleep shortly afterwards. Woke up at approx 10:30 pm to go to bed. Fever was at 99.0, with no headache. Woke up next morning felling much better, with no fever and no headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,None,None,None,,None,"['Fatigue', 'Headache', 'Malaise', 'Nasopharyngitis', 'Pain', 'Pyrexia', 'Rhinorrhoea']",2,PFIZER\BIONTECH,SYR 932765,IN,23.0,F,Joint soreness. Headache.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,"Tri sprintec, pantoprazole, montelukast",,"Asthma, eosinophilic esophagitis",,Eggs,"['Arthralgia', 'Headache']",1,PFIZER\BIONTECH,SYR 932766,IL,36.0,F,Throat fullness with frequent coughing,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,Unknown,none known,none known,,possible sulfa allergy as child,"['Cough', 'Throat tightness']",1,PFIZER\BIONTECH,SC 932767,NC,41.0,F,"I had an adverse reaction 10 minutes after my injection. My heart rate went up as well as my BP, I felt hot and faint. Ems was on site and monitored until ambulance arrived. I was given Benadryl immediately.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PUB,Pepcid,None,"Mast cell Activation syndrome, rheumatoid arthritis, migraine, asthma",,"Cipro, tramadol, penicillin, nexium","['Blood pressure increased', 'Dizziness', 'Feeling hot', 'Heart rate increased']",1,PFIZER\BIONTECH,SYR 932768,IN,34.0,M,"Fatigue, severe body aches x 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,OTH,Vyvance,None,ADD,,None,"['Fatigue', 'Pain']",2,PFIZER\BIONTECH,IM 932769,WA,37.0,M,"At 1712 on January 8th, three hours after the vaccination, patient presented to the Urgent Care with c/o dizziness, tachycardia and shortness of breath. Other symptoms included fatigue, foggy headed and poor appetite. As of today, January 10th, continues to complain of exhaustion, mild shortness of breath and body aches, but states that the tachycardia has resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,None,Possible viral illness on morning of vaccination. Woke up with fatigue and mild aches. COVID negative by PCR.,None,,None,"['Decreased appetite', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Fatigue', 'Feeling abnormal', 'Pain', 'SARS-CoV-2 test negative', 'Sinus tachycardia']",2,PFIZER\BIONTECH,IM 932770,NY,58.0,M,"pain in shot arm 1st day, woke up 2nd day feeling achy, about 30 hrs after the shot real achy and tired, that night about 40hrs after shot went to bed.. woke up 5 hrs later exhausted, 102.5 fever, whole body felt like I was hit by a truck then a train, sore arm, swollen gland under shot arm.. this was after my 1st Moderna shot. I had covid , very mild in March/April 2020,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"wellbutrin, crestor, lexapro",none,high cholesterol,,none,"['Fatigue', 'Injection site pain', 'Lymphadenopathy', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 932771,TN,36.0,F,"Syncope at approximately 5:20am this morning. I had been awake and active for about 30 minutes getting ready for work. As I was walking to my kitchen, I suddenly became very dizzy with blurred vision, tingling hands, nausea, ringing in my ears, and I felt like I was going to lose control of my bowels. I became very weak in the legs and I made it to the couch before I fell. Episode lasted approximately 2 minutes. As I laid down, my symptoms recovered. My husband gave me some juice and toast. After about 20 minutes, I got up and was able to walk without symptoms. I felt perfectly normal prior to this event. Last night, I ate a full dinner and drank about a liter of water. This event did not seem to be precipitated by hypoglycemia or dehydration. For the rest of this day, I have felt normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,-Imatinib (Gleevec) 400mg by mouth once daily,none,Chronic Myeloid Leukemia,,none,"['Dizziness', 'Fall', 'Muscular weakness', 'Nausea', 'Paraesthesia', 'Syncope', 'Tinnitus', 'Vision blurred']",2,PFIZER\BIONTECH,IM 932772,CA,46.0,F,"Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway constriction but on the outside). Severe heartburn, burping and reflux, anxiety, slightly elevated heart rate about 30 mins after injection, lasting about 30 mins. 5 hours after injection, after eating a small snack, repeat of heartburn, burping and reflux. Felt hot but temperature 97.7, then chills briefly. Anxiety and related fast heart beat and shallow breathing for about 1 hour. Took benadryl, no change.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,"Levothyroxine (Tirosint), Valtrex, Allegra",,"Hypothyroidism, Vitiligo",,NKA,"['Anxiety', 'Chills', 'Dyspepsia', 'Eructation', 'Feeling hot', 'Gastrooesophageal reflux disease', 'Heart rate increased', 'Hypopnoea', 'Neck pain', 'Throat tightness']",1,PFIZER\BIONTECH,IM 932773,SC,34.0,M,"Nausea, vomiting, fevers, chills, myalgias, arthralgias, severe fatigue, severe headache, muscle stiffness, blurred vision, dizziness,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,UNK,None,None,None,,None,"['Arthralgia', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Musculoskeletal stiffness', 'Myalgia', 'Nausea', 'Pyrexia', 'Vision blurred', 'Vomiting']",1,PFIZER\BIONTECH,IM 932774,SD,56.0,F,On day 8 post-vaccine the patient developed some itchy hives patches on forearms and neck. given a dose of Benadryl. no ongoing concerns.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,PVT,,,,,,"['Pruritus', 'Urticaria']",1,MODERNA,IM 932775,CA,50.0,F,"Chills/shivers, injection site pain, back pain/body aches, nausea, syncope, low blood pressure Started getting chills at 0300, back pain started and injection arm became very painful. at 0430, got out of bed, nausea became severe and I passed out for 2 minutes. Subsequently fractured my nose from the fall after passing out and ended up in the ER for 6 hours with low blood pressure.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Estrodial vaginal cream,none,none,,none,"['Back pain', 'Blood count normal', 'Chest X-ray normal', 'Chills', 'Facial bones fracture', 'Fall', 'Hypotension', 'Injection site pain', 'Loss of consciousness', 'Nausea', 'Pain', 'Skin laceration', 'Syncope']",2,PFIZER\BIONTECH,IM 932776,PA,57.0,F,Nausea Stomachache Headache Chill no fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PHM,Magnesium Citrate Centrum Vitamin Meloxicam 2 ES Tylenol 1 Neurontin all take in the morning of vaccination Lipitor at 6PM night of vaccination Trazodone at 10 Pm night of vaccination,None,Arthritis Ostectomy,,Cat dander and mold r allergy Childhood allergy and probably grew out already Penicillin Amoxicillin Bactrim Not sure if still aler,"['Abdominal pain upper', 'Chills', 'Headache', 'Nausea']",1,MODERNA,IM 932777,IL,25.0,F,ER visit on 12/25/2020 for tachycardia and SOB. She was to follow up with her PCP.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/25/2020,2.0,WRK,Unknown,Unknown,Unknown,,Unknown,"['Dyspnoea', 'Tachycardia']",1,PFIZER\BIONTECH,SYR 932778,PA,51.0,F,"Allergic reaction 10 minutes after injection. High BP 171/110, chest tightness, eye swelling, left back of shoulder, neck, face pain , moderate severe headache. SOB.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,"Buspar 10 mg 3times a day, Premarin.625mg, Cymbalta 120 mg, Gabapentin 600 mg two times a day. Hydralazine 50 mg two times a day. Levothyroxine 125mcg, Metformin 1000 mg daily, montelukast 10 mg daily, Nadolol 20 mg two times a day,",None,"Fibromyalgia, Depression, Anxiety ,",,Reglan,"['Arthralgia', 'Chest discomfort', 'Dyspnoea', 'Eye swelling', 'Facial pain', 'Headache', 'Hypersensitivity', 'Hypertension', 'Neck pain']",2,PFIZER\BIONTECH,IM 932779,ID,49.0,F,"Woke up with a severe migraine at 3:30 am, and again the following night another migraine. Also had swelling and a red lump at site of injection, with pain and soreness around injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PHM,,none,,,"sulfa, penicillin, cipro, morphine,","['Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site swelling', 'Migraine']",1,PFIZER\BIONTECH,IM 932780,IA,44.0,F,"Swelling, redness and pain at injection site with pain going down to elbow",Not Reported,,Not Reported,Not Reported,,Not Reported,N,11/30/2020,01/09/2021,40.0,WRK,"Aszo yeast, vitamin d",Non,"Allergies, depression, reflux, Arnold chiari",,"Wellbutrin, omperazole, viibryd, straterra","['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 932781,GA,22.0,F,Tachycardia starting at ~10:30pm on 01/06/2021 that persisted for ~1.5-2 hours. Heart rate in mid to upper 130s for ~1 hour followed by 0.5-1 hour of heart rate in the 110-120s. Also accompanied with flushing and redness of both ears and chills/shivering that resolved in the same timeframe of ~1.5 hours. (Normal/baseline HR of 65-70bpm at rest).,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PHM,Cetirizine 10mg once per day ProAir HFA 90mcg as needed,none,"Asthma - well controlled, Hypermobile Ehlers Danlos Syndrome (hEDS) Raynaud's Disease Erythromelalgia",,Penicillin,"['Chills', 'Erythema', 'Flushing', 'Tachycardia']",1,MODERNA,IM 932782,OR,41.0,F,"Felt woozy, had nausea, achy muscles, felt like I was walking through quicksand, general malaise for about 30 hours afterward. If that is any sign of how covid feels, I am so grateful for the shot. I did not take anything because I wanted my body to fight it off.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Prozac, zyrtec, montelukast, Winelands, multivitamin, magnesium",,"Asthma, seasonal allergies, depression, anxiety",,None known,"['Dizziness', 'Feeling abnormal', 'Malaise', 'Myalgia', 'Nausea']",1,MODERNA,SYR 932783,TX,30.0,M,"COVID-19 Vaccine (Pfizer) EL3302 Exp 05/21. Tingling in left arm and hand(same arm as side of injection) following adminstration of Dose#2. Patient also reports that he experienced numbness immediately after the first dose which went away after about 1 hour, followed by fatigue. All symptoms resolved by next morning following the first dose. BP 134/82 HR=71 @1:45pm. Patient clinically stable. Symptoms of tingling resolving. Patient was released from clinic at 1:50pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,None,None,None,,None,"['Fatigue', 'Hypoaesthesia', 'Immediate post-injection reaction', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 932784,PA,54.0,F,"Moderna COVID-19 Vaccine EUA Tenderness injection site, fatigue,headache,chills,muscle pain,nausea. Migraine lost two days of work because of the reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,None,None,Migraine,,None,"['Chills', 'Fatigue', 'Headache', 'Impaired work ability', 'Myalgia', 'Nausea']",1,MODERNA,SYR 932785,TX,41.0,F,"COVID-19 Vaccine (Pfizer) EL3302 Exo 05/21. Itching and redness (flushing) on chest, stomach, legs occurring 10 minutes after receiving vaccine. Face was flushed red no itching. Initial BP 152/99 HR 84. Benadryl 50 mg PO and famotidine 20 mg PO administered. Patient reports similar reaction following the first dose of the vaccine - COVID-19 Vaccine (Pfizer) EL0140 Exp 03/21; itching resolved without medication the first time. Patient reports that this reaction is slightly worse than previous reaction to the first dose. At 3:48pm, BP 151/87 HR 82 O2=96%. Patient itching and redness on chest and flushing of face dissipating by 3:45pm. Patient clinically stable. Patient dismissed from clinic at 3:54pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Zyrtec,None,Asthma,,Penicillin (flushing),"['Erythema', 'Flushing', 'Pruritus']",1,PFIZER\BIONTECH,IM 932786,IL,24.0,F,"received 1st dose covid19 vaccine on 12/18 and experience minimal soreness at injection site that resolved within 36 hours. 12/25 R arm became very sore and i developed a large, palpable ""knot"" at the injection site. The morning of the 26th it became very itchy and a visible raised welt/knot (approx 5cm) formed, skin around site was red and hot. Resolved by 12/28",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/26/2020,8.0,PVT,"sertraline, adderall, birth control",,asthma,,sulfa (rash),"['Injection site erythema', 'Injection site nodule', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Pain in extremity', 'Rash papular']",1,PFIZER\BIONTECH,IM 932787,GA,70.0,F,"RECIEVED VACCINE 1/8/21 EXPIRED UNEXPECTED 1/10/21, NO ADVERSE REACTIONS NOTED",Yes,01/10/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/10/2021,2.0,SEN,"CRANBERRY, PROZAC, NEUROTIN PERCOCET, IMMODIUM, SYNTHROID, LINZESS, LIPITOR, MELATONIN METFORMIN, PROTONIX PLAVIX, PROAIR, ropinirole, PROAIR SYMBICORT, THIAMINE TYLENOL VIT C VOLTAREN. ZANAX, ZOFRAN",PNEUMONIA,DEPRESSION CHRONIC LUNG ANEMIA,,"TRAMADOL, methocarbamol",['Death'],1,PFIZER\BIONTECH,IM 932788,TX,64.0,F,"Patient experience tension and tightness on right upper shoulder / right neck area. Patient received vaccine in the right arm. At 4:40pm, BP 171/93 HR 62 O2=95%. Symptoms are stable. Not worsening. At 4:49pm, BP 153/95 HR 61 O2=95%. Patient clinically stable. Patient still has tension on right shoulder/neck. Patient released from clinic at 4:53pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,"Metoprolol, Lisinopril, Hydrochlorothiazide, fish oil",None,"Hypertension, allergies",,None,"['Muscle tightness', 'Musculoskeletal stiffness', 'Tension']",1,PFIZER\BIONTECH,IM 932789,SC,40.0,F,"Approx 12 hours after injection fever (t-max 101.3), chills, body ache, head ache, skin ache, and fatigue lasting approx 24 hours. Severe fatigue lasted 48 total hours. Fully back to normal 4 days after vaccine. These were severe symptoms, but those that were expected. I only report here because I didnt know how else to make side effects known, in case this is still being followed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,OTH,None,None,None,,Allergy to ammonia. Food intolerances: lactose and red meat,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pain of skin', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932791,TX,33.0,M,"Sore right eye prior to vaccination and stuffy nose prior to vaccination. Headache (6 out of 10) and runny nose started after receiving vaccine. BP 145/89 HR \=76 O2=96% and Temp=98.6F at 1:55pm. BP 142/89 HR=67 Temp=98.6F, O2=96% at 2:05pm. Patient reports having allergies prior to receiving vaccine, but nose started running excessively after receiving the vaccine. Vision started to blur in right eye. Offered patient to go to ED, but he didn't feel the need to. He will contact his physician, if necessary. Patient clinically stable. Patient released from clinic at 2:18pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/10/2021,0.0,PVT,"Albuterol, Benadryl, Descovy",Allergies,Asthma,,Doxycycline (closes airway),"['Eye pain', 'Headache', 'Nasal congestion', 'Rhinorrhoea', 'Vision blurred']",1,PFIZER\BIONTECH,IM 932792,CA,33.0,F,I had swollen armpit lymph node on the left arm 6 days later after the first dose of the Pfizer vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/26/2020,6.0,UNK,,,,,Shrimp and Bactrim,['Lymphadenopathy'],1,PFIZER\BIONTECH,IM 932793,IL,28.0,M,"Chills for 12 hours (no fever), mild headache the day after, rash starting 2 days after",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Headache', 'Rash']",2,PFIZER\BIONTECH,IM 932794,IN,51.0,F,1. Migraine headache that will not go away with Ibuprofen. 2. Body aches 3. Fatigue 4. Numbness and tingling in the arm the vaccine was administered in,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Fatigue', 'Hypoaesthesia', 'Migraine', 'Pain', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 932795,TX,38.0,F,Right axillary pain and swelling less than 48hrs after,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/10/2021,2.0,PVT,"Zoloft, nuvaring",None,MS,,None,"['Axillary pain', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 932796,NY,39.0,F,"15 minutes post injection, I was tachycardic, lightheaded, nearly fell over (nurse caught me as I started to sway), and my throat felt thick like something was stuck in it. Staff sat me into a recliner and called an ICU attending. Benedryl IM was given. Throat symptoms did not get worse but did take about 10-12 hours to resolve.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,N/a,Post COVID syndrome,Post COVID syndrome,"Flu shot - anaphylaxis. I don?t remember when I last had it, it?s been over a decade.",Flu shot - anaphylaxis,"['Balance disorder', 'Dizziness', 'Oropharyngeal discomfort', 'Tachycardia']",1,PFIZER\BIONTECH,IM 932797,LA,27.0,M,"Was perfectly fine and felt great before but around 2100 about 12 hours after i received the vaccine i started to get flu like symptoms where my body kept shivering, shaking uncontrollably, cold sweats, 100.7 fever, headache like no other, and arm hurt like a tetanus shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,MIL,None.,None.,None.,,None.,"['Chills', 'Cold sweat', 'Headache', 'Influenza like illness', 'Pain in extremity', 'Pyrexia', 'Tremor']",UNK,MODERNA, 932798,AR,53.0,F,"About 11 hours after the vaccination, Monday 01/04/2021, I started getting chills, headache, puking, then muscles aches. I notified my direct supervisor how I was feeling. I woke up on Tuesday morning with the sickness and I called off work. I got into contact with my Doctor, on Wednesday and had a tele-appointment. He gave me three medications, and currently it has lasted for six days, and I am going to try and get an appointment with the doctor on Monday 01/11/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,SEN,Ibuprofen 800 MG,None,Osteopathic Arthritis. Long time of varicose veins on legs. Suffered the last 2 years with kidney stones.,,Vicodin,"['Chills', 'Headache', 'Illness', 'Impaired work ability', 'Myalgia', 'Vomiting']",1,MODERNA, 932799,IN,52.0,M,Severe HA with mild myalgia. Felt feverish but temp never exceeded 98.6.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Multivitamin, Vit D3, Airborn, Crystaline Nicotinamide Riboside, Pterostilbene",None,Herniated disc that has been essentially asymptomatic for 20 years.,,PCN,"['Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932800,NJ,19.0,F,"Fever, chills, aches, muscle pain, joint pain, dizziness, headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,UNK,Zoloft 100 mg,Unknown virus,,,Tree nuts,"['Arthralgia', 'Chills', 'Dizziness', 'Headache', 'Myalgia', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 932801,IL,32.0,M,Two days following the first COVID vaccination he developed epigastric pain and was evaluated in the ER and was admitted for gallbladder surgery. He has a 6 year history of gallbladder disease but was not experiencing symptoms until after the COVID vaccination.,Not Reported,,Not Reported,Yes,,Not Reported,Y,12/17/2020,12/19/2020,2.0,WRK,Unknown,,Hx of gallbladder disease,,Unknown,"['Abdominal pain upper', 'Condition aggravated', 'Gallbladder disorder', 'Gallbladder operation']",1,PFIZER\BIONTECH,IM 932802,CT,59.0,F,"Lower back pain and slight fever beginning at 1am 14.5 hours after shot. Just tired and back achy by 4:30 pm the day after the shot For a few hours about 8 hours after shot, arm where shot was given was quite sore, but that went away",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,Atorvastatin 20 mg - once daily Losartin Potassium 25 mg - once daily,Seasonal allergies,"? High Cholesterol, moderate/high blood pressure",,Contrast dye used in CAT Scans,"['Back pain', 'Fatigue', 'Injection site pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 932803,TX,50.0,F,"swollen lips and tongue and rash I woke at 8 am with swollen lips and my tongue felt funny. I took 50 mg of benadryl at 815, at 830 I took zyrtec 10 mg and went to the ER. At 945 they gave me a shot of decahedron and discharged me at 10 30 with prescription for oral steroids, epi pen and instructions to take pepcid, zyrtec twice daily and benadryl as needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/10/2021,2.0,WRK,gabapentin synthroid fluoxetine dextromethorphan guaifenesin sudafed,,"seasonal allergies, back and neck pain, depression, anxiety, hypothyroid",,Sulfa Penicillin,"['Lip swelling', 'Rash', 'Swollen tongue']",2,PFIZER\BIONTECH,IM 932804,NM,76.0,M,Chills - heavy sweating (45 minutes) - headache - fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/08/2021,2.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Hyperhidrosis']",1,PFIZER\BIONTECH,SYR 932806,,48.0,F,"Moderna Covid-19 Vaccine EUA Fever, for 2 days so far, with chills on first night, treated with Tylenol Extreme fatigue, for a day, treated with rest Injection site pain, persisting on day 3, treated with ice and heating pad Headache for 1 day, treated with Tylenol Mild nausea and loss of appetite for 1 day",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,UNK,,,,,,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pyrexia']",1,MODERNA,IM 932807,MN,36.0,F,"bump and redness @ injection site, occurred on day 13 post-vaccine - no concerns @ time of injection or day after. reporting as req'd by employee health program, not clinical significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,01/05/2021,13.0,PVT,,,,,,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 932808,FL,23.0,M,"Had vaccine on 1/7/2021 afternoon, the next morning and Saturday and Sunday developed difficulty breathing, dizziness, fatigue, headache and went to Medical Center ER was evaluated and a COVID test was done. Results pending. No blood work, CXR, or EKG was done. Patient reports symptoms are now intermittent seem to be improving. Patient will check on hospital website for COVID results",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,MIL,None,None,None,,None,"['Dizziness', 'Dyspnoea', 'Fatigue', 'Headache', 'SARS-CoV-2 test']",1,MODERNA,IM 932809,TX,74.0,F,"Fever, chills, achy, tired, slight headache all over a period of 30 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Hydrochloride, losartan, allopurinol, metoprolol, lutein, vitamin D, tonic, meloxicam",Cold,None,,None,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,SYR 932810,TX,57.0,F,Mild General whole body Itchiness ; tachycardia; body tingling sensation Administered 50mg Benadryl 4mg Dexamethasone 1-10-21 @ 11:28am monitored and resolved by 12pm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,SEN,Vitamins,No,no,,,"['Paraesthesia', 'Pruritus', 'Tachycardia']",1,PFIZER\BIONTECH,IM 932811,FL,71.0,F,"Three itchy vesicular lesions on upper left three days after vaccine lasting three days thus far. Headache first twenty four hours. Tylenol, Neosporin ointment, Cortisone cream, Anti-itch cream",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/08/2021,3.0,OTH,"Metoprolol, Hydrochlorothiazide,Lisinopril.Escitalopram,Trazodone,Alprazolam,Vitamin D 2000 IU, VitaminC 250 mg",,"Hypertension. MVP, arthritis, melanoma",,Peach fuzz,"['Headache', 'Rash pruritic', 'Rash vesicular']",1,PFIZER\BIONTECH,IM 932812,NY,69.0,F,severe single joint pain (ankle) couldn't stand,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,thyroid,none,,,NKDA,['Arthralgia'],UNK,MODERNA, 932813,NY,41.0,F,"I received the vaccine at 12:59 pm and at 1:05 pm my heart began to beat rapidly. I felt heat rush into the left side of my head, I was extremely light headed and couldn?t catch my breath. I asked if there was a nurse that could help me. There was 1 paramedic watching everyone. I stepped outside, took my mask off to catch my breath. One staff member accompanied me and sat next to me. I began to shake in my legs and arms involuntarily, my heart kept beating and I just tried to do deep breathing techniques to catch my breath. The paramedic came outside and asked if I wanted help. I declined his help and I called my husband who was sitting in the car to help me walk to our car. At 1:15, my heart was beating less rapid, I walked back to the car and as my husband was driving us home, my heart began to beat rapidly again, I felt burning and heat in my head and I began to shake in my arms and legs. It lasted about 10-15 minutes. We got home and I could barely walk into the house because I was so weak in my legs. I went to bed where my heart began beating back to normal after 1 hour or so.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/10/2021,0.0,OTH,,,,,,"['Burning sensation', 'Dizziness', 'Dyspnoea', 'Gait inability', 'Heart rate increased', 'Muscular weakness', 'Skin warm', 'Tremor']",1,MODERNA,IM 932814,NC,43.0,M,"Fevers, chills, myalgias, body aches, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,Multivitamin,None,Tinnitus,,No known food or drug allergies,"['Chills', 'Malaise', 'Myalgia', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 932815,CA,32.0,F,"Myalgias, fevers, chills, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,,,,,Suprax,"['Chills', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932816,GA,50.0,F,"Severe headache nonstop, at the front and back of head, eyebrows, and around the temples",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Zyrtec,,,,Ibuprofen,['Headache'],1,MODERNA, 932817,PA,66.0,M,"Within 24 hours, I began experiencing bouts of severe pruritis starting in the lower extremities. Rash developed in areas of excoriation due to severe itching, pinpoint red macules. The episodes of pruritis were not responsive to Benadryl Zyrtec or Claritin. For two nights I took Vistaril with mild relief. Medrol dose pack was ineffective. Over the next week the episodes increased in intensity and frequency and were often accompanied by localized redness and superficial swelling of the skin and hive like raised areas of the skin as in urticaria. The areas of localized pruritis migrated over a period lasting 7 to 10 days, first to inner surfaces of both my arms, then to my lower back, and then to my upper back over scapulae and shoulders. Concurrently, the pruritis and rash began resolving in the lower extremities and then on the inner aspect of my upper extremities. Currently, the intensity and frequency of the pruritis has decreased significantly and is now localized to my upper back. Yesterday was the first day that I did not require antihistamines.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/25/2020,2.0,PVT,"Januvia, Rosuvastatin, Lisinopril- Hydrochlorothiazide","Hypertension, Diabetes, High cholesterol",As above,,Penicillin,"['Blood test', 'Macule', 'Pruritus', 'SARS-CoV-2 test negative', 'Skin swelling']",1,MODERNA,IM 932821,OH,33.0,F,"No adverse reaction until one week after vaccination. Seven days afterward, the site of injection became itchy and red blotches formed on the arm below the injection site. Pruritus lasted for a couple days and blotches on skin resolved after about a week.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,PVT,"Apri, Prilosec OTC",,,,NKA,"['Injection site erythema', 'Injection site pruritus', 'Rash macular']",1,MODERNA,IM 932822,NJ,54.0,F,"15 hours of feeling febrile with no fever and severe body aches - next day woke with a painful and very swollen arm pit in the arm where i was vaccinated, today is day 2 of swollen painful arm pit.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,UNK,Tylenol and Advil,None,None,,No allergies,"['Axillary pain', 'Lymphadenopathy', 'Pain']",2,PFIZER\BIONTECH,IM 932823,,45.0,M,"Diaphoresis, petechiae, and tachycardia. onsent post vaccine, Benadryl 25 mg by mouth, 2nd round of sweating onsent: Benadryl 25 mg by mouth. Lower lip swelling, administered Epi-pen, called rapid response. Transferred to ED at 09:11am",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/10/2021,01/10/2021,0.0,PVT,,,,,,"['Hyperhidrosis', 'Lip swelling', 'Petechiae', 'Tachycardia']",1,PFIZER\BIONTECH,IM 932824,SD,61.0,F,the day after vaccination she went home at 3pm feeling sleepy with chills and injection site warmth/pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,,,,,"guaifenesin, dextromethorphan, indomethacin.","['Chills', 'Injection site pain', 'Injection site warmth', 'Somnolence']",1,MODERNA,IM 932825,FL,69.0,F,A Itchy red rash at injection site Raised and swollen Just started a few days ago Still there but seems to be getting better,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/08/2021,9.0,UNK,Levoxyl 75 Metropolis Omeprazole Rosuvastatin,None,Thyroid Irregular Heartbeat,,Penicillin Sulfur drugs,"['Injection site rash', 'Injection site swelling', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",1,MODERNA,SYR 932826,MO,51.0,F,"Severe weakness, body aches, joint pain, fever of 100.7, chills, headache, fatigue, body rash",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,WRK,Bevusibmab Irintican 5FU Folic acid Vitamin D ASA 325,None,Stage IV colon cancer,,Nkda,"['Arthralgia', 'Asthenia', 'Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia', 'Rash']",1,MODERNA,IM 932827,IL,29.0,F,Pt complaints of itching and hives. Liquid Benadryl give(25mg) Pt symptoms resolved,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,UNK,None,None,Hives and swelling in mouth,UNK,"['Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,IM 932828,MI,64.0,F,Fever (100.5 F oral temp) Body Aches Headache Chills Fatigue Pain at Right Deltoid Injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,Ibuprofen Protonix,None,Arthritis,,Nkda,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932829,IL,62.0,F,"Patient reports she received the Covid-19 vaccine at 0835. She reports at 0905 symptoms of tingling at the tip of the tongue. No other symptoms, no respiratory distress. SP02 = 99%, P = 75, B/P = 141//85. � 0910, tingling of tip of tongue continues but has not increased, no respiratory distress, no other symptoms. SP02 =100%, P = 72, B/P = 132/88. Rapid response team called. � At 0915, tingling of tip of tongue continues but has not increased, no respiratory distress, no other symptoms. SP02 = 100%, P = 74, B/P = 130/83. � At 0920 Rapid Response Team arrived. Care of pt. transferred to RRT. RRT talking with pt. regarding transfer to ED vs. discharge home Patient reports she received the Covid-19 vaccine at 0835. She reports at 0905 symptoms of tingling at the tip of the tongue. No other symptoms, no respiratory distress. SP02 = 99%, P = 75, B/P = 141//85. � 0910, tingling of tip of tongue continues but has not increased, no respiratory distress, no other symptoms. SP02 =100%, P = 72, B/P = 132/88. Rapid response team called. � At 0915, tingling of tip of tongue continues but has not increased, no respiratory distress, no other symptoms. SP02 = 100%, P = 74, B/P = 130/83. � At 0920 Rapid Response Team arrived. Care of pt. transferred to RRT. RRT talking with pt. regarding transfer to ED vs. discharge home",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/10/2021,0.0,PVT,,,,,,['Paraesthesia oral'],2,PFIZER\BIONTECH,IM 932830,TN,88.0,F,Moderna COVID-19 Vaccine EUA Day1 after injection - soreness & slight swelling at injection site on right arm Day 2 - ? Day 3 - Right shoulder became sore & had twinges of pain Day 4 - ? + hard to raise right arm - very painful every time it was moved. Unable to undress without help. Extremely painful. Took Tylenol & used heating pad. Day 5 - unable to move right arm at all without extreme pain. Taking Tylenol. Right rotator cuff was previously repaired surgically in 2005. No issues in 15 years until now.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/08/2021,3.0,UNK,"Levemir insulin, Glipizide, Diltiazem, Trimethoprim, Pravastatin, Montelukast, Gabapentin, Symbicort, HFA albuterol, Clonidine, aspirin, Vitamin D, zinc, Vitamin B12, Citracal, Tylenol, Miralax, Metamucil, Pepcid",,Diabetes Diabetic neuropathy Asthma Chronic kidney disease Sleep apnea Hypertension Aneurysm in kidney GERD,,"Not necessarily allergies but side effects: Hydrocodone, Vicodin, Lortab, Percocet - itching Lipitor - leg cramps; Levaquin - various side effects; Bactrim; Macrobid - elevated BP, hurts feet; Lyrica - chills & fever; Chlorthalidone; Jardiance","['Injected limb mobility decreased', 'Injection site pain', 'Injection site swelling', 'Loss of personal independence in daily activities', 'Pain']",1,MODERNA,SYR 932831,WA,23.0,M,"Fever, chills, lethargy. No relief from tylenol. All symptoms within 24 hours of vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Lethargy', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932832,MO,37.0,F,"I woke up this morning with swelling (angioedema) around my eyes. I took 50 mg of Benadryl and the swelling reduced, but isn't gone. About an hour after Benadryl I had some shortness of breath and dizziness that improved with sitting down. I have also had stomach cramping and diarrhea that began aroun noon. Diarrhea symptoms have improved with use of Imodium.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,WRK,"Sertraline 100 mg daily, Melatonin 3 mg PRN, Tylenol PRN",None,"Endometriosis, Idiopathic Uticaria/Andioedema, IBS, Asthma",,"Vicodin, all NSAID drugs","['Abdominal pain upper', 'Diarrhoea', 'Dizziness', 'Dyspnoea', 'Periorbital swelling']",1,PFIZER\BIONTECH,IM 932833,OR,46.0,F,mild nausea 12/25 and 12/26,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,UNK,none,none,none,,none,['Nausea'],1,PFIZER\BIONTECH,IM 932834,CT,45.0,F,"Hot flash while driving. Hot flash ended after a few minites but breathing was labored during hot flash. Took deep breaths with open car window for remainder of car ride (5 minutes). When home, lightheadedness to the point that I called my husband home. Drank water and sat for 2 hours until lightheadedness resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Nifedipine, synthroid, iron supplemwnt, claritim, flonase. Women's multivitamin",None,"Hypothyroidism, hypertension",,Sulfa,"['Dizziness', 'Dyspnoea', 'Hot flush']",1,MODERNA,IM 932835,CA,50.0,F,15 minutes after vaccine patient was very sleepy. VSS patient became progressively sleepy and c/o eyelids and tonge with slight swelling. transported to ED via wheelchair,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/10/2021,0.0,PVT,levothyroxine epi pen,unknown,"HYPERLIPIDEMIA SEVERE OBESITY EQUIVALENT (BMI 35-39.9 W CO-MORBIDITY) HYPOTHYROIDISM � ALLERGIC RHINITIS � OBESITY, BMI 35-39.9, ADULT � GASTRITIS � HX OF THYROIDECTOMY � TOBACCO SMOKER � MEDI-CAL GMC CARE COORDINATION � ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE � RIGHT FIFTH METATARSAL FX",,"seafood, shellfish; tomato","['Somnolence', 'Swelling of eyelid', 'Swollen tongue']",1,MODERNA,IM 932836,MA,67.0,M,1/8/20 Around noon got very cold and around 430 broke into seizure like chills and tempeture and fever took two tylenol(650)mg went to bed and woke at at 2;00 fine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/10/2021,3.0,OTH,take HBP diabetic meds,Covid beginning December,diabetic cardio,,NKDA,"['Chills', 'Feeling cold', 'Pyrexia', 'Seizure like phenomena']",1,MODERNA,IM 932837,,43.0,M,"Beginning at 11pm - chills, headache, nausea, muscle aches, sleeplessness, anxiety, high blood pressure, pulse 100+ . Syptoms lasted until 3pm the following day. Seemed to improve after taking benadryl. Aleve did not help.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,None,None,None,,None,"['Anxiety', 'Chills', 'Headache', 'Hypertension', 'Insomnia', 'Myalgia', 'Nausea']",1,MODERNA,IM 932838,CA,65.0,F,"Vaccinated at 8 am,at about 7 pm I had site and muscle pain 12/31/20,then 48 hours I had loss of smell and taste,body aches,I was itchy all over,could not sleep that nite,I called did the Conversation at work and told me not to go to work,the next day 1/3 /21,employee health called me to get tested and tested positive on 1/4/21,I was place on quarantine for 10 days,I tried calling your office with 800 number and left my number nobody called me,I also experienced eye irritation,cough ,short of breath,low grade fever,nausea fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,WRK,"Losartan,vitamin d3,multi vitamins,fish oil,baby aspirin,colace,hair and nail vitamins",Seasonal allergies,"Asthma,htn",,"Erythromycin,Darvon","['Ageusia', 'Anosmia', 'COVID-19', 'Cough', 'Dyspnoea', 'Fatigue', 'Impaired work ability', 'Injection site pain', 'Myalgia', 'Nausea', 'Pain', 'Pruritus', 'Pyrexia', 'SARS-CoV-2 test positive', 'Sleep disorder']",1,PFIZER\BIONTECH,IM 932839,NY,27.0,F,"Patient complained of feeling hot, flushed and nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Feeling hot', 'Flushing', 'Nausea']",1,PFIZER\BIONTECH,IM 932840,PA,44.0,F,Severe headache turned into migraine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Cymbalta Areva,,Rheumatoid arthritis,,Lyrica Shellfish,"['Headache', 'Migraine']",1,MODERNA,SYR 932841,CO,29.0,F,"GERD x 4 days, nausea x 4 days - neither of which are something I've ever experienced before",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,Birth control,None,None,,None,"['Gastrooesophageal reflux disease', 'Nausea']",2,PFIZER\BIONTECH,IM 932842,WA,48.0,F,"1: 12/20/20: 4:30pm: headache, injection soreness, tiredness, feeling worn out: started around 8pm lasting through next day 2: 1/9/21: 9am: headache, injection soreness, tiredness, feeling worn out, chills, body aches, chest tightness: started around 8pm lasting to next day (today)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,OTH,"Baby Asperin, Lisinopril, Vitamin D, Multivitamin",,"Factor IV Leiden, Diabetes",,Sulfa,"['Chest discomfort', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pain']",2,PFIZER\BIONTECH,IM 932843,MI,64.0,F,Fever (oral temp 100.5) Body Aches Chills Headache Fatigue Right arm pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,Ibuprofen Protonix,NONE,ARTHRITIS,,NKDA,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932844,CA,33.0,F,I had a swollen armpit lymph node on the left arm where the injection site is for 3 days. The swelling was noticeable along with sore pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/26/2020,6.0,UNK,Elderberry gummies,,,,Shrimp and Bactrim,"['Axillary pain', 'Lymphadenopathy']",UNK,PFIZER\BIONTECH, 932845,GA,34.0,M,"After 15 minute observation states, feels hot, dizzy ""off"", B/p135/90, HR 74, 02Sat 98%, monitored for additional 15 minutes symptoms resolved, b/p 124/62, HR 69 and 02 Sat 98%.EE was able to return to work",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,,,,,,"['Dizziness', 'Feeling abnormal', 'Feeling hot']",1,PFIZER\BIONTECH,IM 932846,ME,26.0,F,"1/9/2021 experienced significant pain at injection site, by 1/10/2021 AM pain had mostly subsided to a level normally associated with vaccines. 1/10/2021 in the morning began experiencing mild intermittent numbness in left hand. 1/10/2021 afternoon began experiencing extreme low back pain when standing and walking. Cannot tie any of these symptoms to other causes. Back pain and hand numbness still present at 5 PM 1/10/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/10/2021,2.0,UNK,,None,Asthma,,,"['Back pain', 'Dysstasia', 'Gait disturbance', 'Hypoaesthesia', 'Injection site pain']",1,MODERNA, 932847,AZ,63.0,M,"Only slight soreness at injection site first day. I was physically working hard out of town with limited sleep for next three days. I began experiencing significant body aches and pains, sneezing and minor congestion. However, activity involved substantial dust as I was sanding a floor. Saturday, January 2, I began having more extensive cold symptoms, coughing and runny nose with continued body aches and pains. I scheduled a covid test on Monday, January 4, scheduled for Wed. January 6th. I received positive results on Friday. January 8. On Saturday, January 8, I began developing increased light headedness and self monitored my blood pressure. It was at 191/107 when I went to Hospital to have it checked. I was released that afternoon.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/31/2020,3.0,PVT,"Dupixent, Aspirin, sildenafil , augmentin",,Diverticulas,,,"['Blood test normal', 'COVID-19', 'Computerised tomogram normal', 'Cough', 'Dizziness', 'Electrocardiogram normal', 'Injection site pain', 'Nasopharyngitis', 'Pain', 'Respiratory tract congestion', 'Rhinorrhoea', 'SARS-CoV-2 test positive', 'Sneezing']",UNK,PFIZER\BIONTECH, 932848,IN,23.0,F,The next day i experienced fever chills headache dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Dizziness', 'Headache', 'Pyrexia']",1,MODERNA,IM 932850,IN,41.0,F,"Fever(low grade) , body aches, headaches, dirrhea, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,N/a,,,,,"['Chills', 'Diarrhoea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 932851,KY,57.0,F,Patient starting feeling flushed ~10 mins after vaccine. Her BP remained in the 160's/90's and HR 80-90. She felt better after drinking some water.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,,none,none,,none,['Flushing'],1,MODERNA,IM 932852,VA,54.0,F,Extreme vertigo that has persisted since 1/4. Unsure if this is a vaccine side effect or unrelated.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,PUB,Buproprion that morning. Pantoprazole and Zolpidem that evening.,None,"Aortic valve regurgitation, cerebral aneurysm (stable, 3mm), depression, anxiety, GERD, obesity",,NKDA,['Vertigo'],1,MODERNA,IM 932853,CO,26.0,F,"tennis ball size lump, raised, red, hot to touch, painful",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,cymbalta 30mg prenatal iron 325 magnesium 500mg,,,,None,"['Erythema', 'Pain of skin', 'Skin warm', 'Swelling']",2,PFIZER\BIONTECH,IM 932855,AR,62.0,F,"Fever, chills, nausea, vomiting, dizziness, generalized ache for 24 hours. Tylenol, Zoran, Pepcid",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,No,No,No,,No,"['Chills', 'Dizziness', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 932856,WV,36.0,F,"7 days after she received the vaccine, her arm began to swell and get red (allergic looking arm) and she developed a fever and has chills. The arm is hot to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/09/2021,7.0,PHM,,,,,bacitracin,"['Chills', 'Erythema', 'Peripheral swelling', 'Pyrexia', 'Skin warm']",1,MODERNA,IM 932857,PA,24.0,F,"On the same day after receiving the COVID-19 vaccine, I noticed that I had lost my sense of taste. I was unable to taste food for about 48 hours. At around noon on December 25th, 2020 I regained the ability to taste once again.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,Junel birth control,None,None,,None,"['Ageusia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 932858,CA,40.0,M,"1414- 18min after injection Patient stated he was feeling funny. He reported feeling hot and discomfort to Left side of his neck. Upon evaluation he was mildly tachycardic HR 110. Symptoms began to worsen with redness spreading through his hands and upper torso and pt became diaphoretic. by 1420 Pt BP increased to 171/104. Pt was given IM Benadryl and Decadron per Dr. orders. by 1440 redness had completely resolved and Diaphoresis was gone, HR down to 144/82. by 1500 all Pt's symptoms resolved. Pt was able to be discharged from clinic without s/sx of distress.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Unknown,none that was known,unknown,,unknown,"['Blood pressure increased', 'Erythema', 'Feeling abnormal', 'Feeling hot', 'Hyperhidrosis', 'Musculoskeletal discomfort', 'Tachycardia']",1,MODERNA,IM 932859,WA,29.0,F,"Fever starting 12 hours after injection and lasting 7 days, ranging from 99.1-101.1. Facial swelling (under and around both eyes), starting 12 hours after injection and lasting 7 days. Increasing in severity. General fatigue and weakness starting 6 hours after the vaccine and lasting 7 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,"Junel Fe 1.5/30, Tylenol",,"Allogeneic Bone Marrow Transplant recipient for the treatment of Acute Myeloid Leukemia (2012), Chronic Grafts vs Host Disease, Osteopenia, Transfusion induced Iron Overload.",,Sulfa-based medications,"['Asthenia', 'Fatigue', 'Full blood count normal', 'Metabolic function test normal', 'Pyrexia', 'Swelling face']",1,MODERNA,SYR 932860,OK,54.0,F,"Patient received 2nd dose of covid vaccine 1/9/2020 around 1100. Report having mild reaction (flu-like sx) with first dose. She began experiencing feeling like she was outside of her body about 10 min after receiving her booster. BP was taken and was slightly elevated 140s/90s. Ice packs were provided for hot flashes. Warm blankets provided for chills. BP was trending up to SBP 160s then started to decline to normal. Patient was accompanied to restroom by clinic staff and was able to walk without incident. Patient was observed in covid clinic for total of 2 hours and reassured that she was not likely to have worsening of sx at this point. Patient was walked to mother's car by clinic staff and left feeling better. 1/10 - patient presented to ED with low grade fever (100.4), chest pain, severe joint and muscle pain, nausea and ""fog brain."" She reports BP being 187/101 in ED. Given 1L of normal saline, zofran, toradol, and dilaudid. Observed until BP drcreased to SBP 140s. Nausea improved enough to allow her to eat. Labs were WNL, CK normal. Discharged home with diagnosis of ""adverse effect of COVID-19 vaccine""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,"dalaglutide, monelukast, azelastine, fluticasone nasal spray, loratadine, epi-pen, fluticasone furoate-vilanterol 200-25 disk, bupropion, levothyroxine",,"diabetes mellitus, hypothyriodism, OSA, asthma",,Lone star tick disease (red meat allergy),"['Adverse event following immunisation', 'Arthralgia', 'Blood creatine phosphokinase normal', 'Blood pressure increased', 'Chest pain', 'Chills', 'Feeling abnormal', 'Hot flush', 'Influenza like illness', 'Laboratory test normal', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,IM 932861,MS,49.0,F,"About 15 to 20 minutes after injection I began feeling weak, warm & ?tingly?. I then became dizzy & very weak & almost passed out. They laid me from the chair onto the floor & lifted my legs. They took me to the ER & I received IV fluids, IV benedryl & Pepcid. (I received the vaccine at 12:15 & received the IV & meds at 12:57. I have never had an allergic reaction to anything. I?ve also had 4 children, surgeries & blood drawn several times & never fainted or had an episode such as this.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Levothyroxine 50mcg daily Propranolol ER 60 mg daily,None,History of hypothyroid History of migraines,,No known allergies,"['Asthenia', 'Blood glucose normal', 'Dizziness', 'Full blood count normal', 'Metabolic function test', 'Paraesthesia', 'Skin warm']",1,MODERNA, 932862,,38.0,F,"Patient c/o tongue swelling, throat tingle and chest pain. Warm tingling around mouth. VS.Benadryl 25 min 7:43, Epi Pen Eipi-Pen at 07:45, Rapid response called, Epi Pen working. Transferred to ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/10/2021,0.0,PVT,,,Pacemaker,,Lidocaine patch,"['Chest pain', 'Paraesthesia oral', 'Skin warm', 'Swollen tongue', 'Throat irritation']",2,PFIZER\BIONTECH,IM 932863,,,F,None,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None. Infant should have received Hepatitis B vaccine instead of influenza vaccine,"None, newborn",None,,NKA,['Unevaluable event'],1,"SEQIRUS, INC.",IM 932864,NM,48.0,F,Moderna COVID-19 Vaccine EUA,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/03/2021,5.0,PHM,"Norgest/Ethi 0.25, MVI, Vitamin C, Vitamin D, St. John's Wort",none,none,,"E-mycin, NSAIDS, shellfish","['Injection site rash', 'Lymphadenopathy']",UNK,MODERNA, 932865,WV,62.0,M,"Sore arm, tender under arm, headache, nausea, joint pain, made Bell?s palsy start",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PUB,"Amlodipine, lisinopril, metoprolol, rosuvastatin, eliquis","Bell?s palsy , possible COPD.",High blood pressure,,Penicillin,"['Arthralgia', ""Bell's palsy"", 'Condition aggravated', 'Lymph node pain', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 932866,IL,48.0,F,"I began to have pain under my left arm as well as a lot of pain in my left foot (without sustaining an injury). Additionally, I have had all over body aches and chills. All symptoms are still ongoing.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/08/2021,4.0,WRK,"Labetalol, effexor, hydrachlorothiazide, trazadone",None,"High blood pressure, obesity",,None,"['Chills', 'Pain', 'Pain in extremity']",1,MODERNA,IM 932867,,30.0,F,"Patient felt HR elevating, then c/o headache, tachycardia. Monitored closly (see sheet for V.S. etc.) Benadryl 25 mg. by mouth. 7:42 Stable, discharged at 07:42 to self.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/10/2021,01/10/2021,0.0,PVT,,,,,KNDA,"['Headache', 'Heart rate increased', 'Tachycardia']",2,PFIZER\BIONTECH,IM 932868,MI,32.0,F,"On 1/7/20 at 8:00 pm had chills and then took Motrin for chills/shivering. 30 minutes later, checked temperature and it was 100.3 with blankets on. Removed blankets and temp was 99.3. Fatigue with headache the next day on 1/8/20. On 1/9/20 at 2:00 am, had chills and temp 100.8 with blankets on. Removed blankets and temp was 99.5. Resolved with Tylenol. No other symptoms after this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,None,Tested for COVID-19 on 11/30/20 with a positive result on 12/5/20,None,,Allergic to penicillin,"['Body temperature increased', 'Chills', 'Fatigue', 'Headache']",UNK,PFIZER\BIONTECH, 932869,TX,51.0,F,"4 Raised bumps around injection site, in the shape of a ring around the site. Mild itching at site. No redness Headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/10/2021,2.0,PVT,Ibuprofen Tylenol Phenteramine,None,None,,Penicillin,"['Headache', 'Injection site pruritus', 'Rash papular']",2,PFIZER\BIONTECH,IM 932870,,24.0,F,"Swelling in arm , redness in upper arm towards injection site , tenderness , extremely hot to the touch, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,UNK,"Wellbutrin , lexapro , pantoprazole , fish oil , women?s probiotic",,,,Nothing,"['Headache', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Peripheral swelling']",1,MODERNA,IM 932873,NJ,67.0,F,"I received the moderna covid-19 vaccine eua on 12/30/2020 first dose. On jan 6 2021 i experienced itching and slight firmness 2cm below injection site. The next day jan 7 2021 I experienced redness 2 cm below inkjection site which was 9cm long by 5.5cm wide. Presently today jan 10, 2021 the redness is fading and I am not experiencing any itching anymore.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,PVT,"valsartan 80 mg 1 po daily, fenofibric acid delaayed-release capsules 135 mg 1 po daily, levothyroxine sodium 25 mcg 1 po daily, xanax 0.5mg 1 po tid, lexapro 5 mg po hs,,multivitimin 1 po daily, vitamin c 1000 mg 1 po daily, zinc 50 mg 1",none,"htn, high cholesterol,hypothyroid, anxiety, depression, panic attacks",,norvasc and vasotec rash,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus']",UNK,MODERNA,IM 932874,NH,42.0,F,Hard red half dollar sized area where vaccine was given. Warm to the touch. Tender. Arm feels sore to move when reaching above my head to put stuff away in the kitchen and bathroom,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,MIL,Ibuprofen and Tylenol for sprain right hand / wrist,None,Sclerosis of dorsal spine,,PCN,"['Injection site erythema', 'Pain', 'Vaccination site induration', 'Vaccination site pain', 'Vaccination site warmth']",1,MODERNA,IM 932876,TX,55.0,F,"Friday 1-8-21 Nausea began, intensified for a couple of hours - first vomiting began at 9:45 p.m. 2nd at 11:30 p.m. Saturday 1-9-21 Nausea continued. Could not keep food down. First vomiting at 9 a.m. - 6 times total finishing at 10:11 p.m. Saturday night. Chills started at 4:15 p.m. Continuing on and off to present 1/10/2021 at 4:34 p.m. Insomnia - 1-2 hours of fitful sleep each day. Left arm bicep soreness morning of 1-7-21. Aleve resolved. Less than shingles vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,PHM,Propanolol HCL 160 mg Topiramate 50 mg Allegra D 24 HR Flonase 50 MCR,,Ruptured/treated brain aneurysm VP Shunt - hypertension caused by hydrocephalus/side effect of aneurysm Seasonal allergies,,Sulfa medications Minocycline Soy Gluten,"['Chills', 'Insomnia', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 932877,MI,36.0,F,Itchy raised rash all over hands and most of legs with rapid heart rate,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,SCH,Paroxetine 30mg,Na,Na,,No known,"['Heart rate increased', 'Rash', 'Rash papular', 'Rash pruritic']",1,PFIZER\BIONTECH,SYR 932878,WI,49.0,M,"Early in the morning of January 9th, 2021, the day after receiving my first injection, I woke up in bed with extreme soreness and moderate swelling at the injection site. On a scale from one to ten, the level of discomfort was seven or eight. I had expected at least some soreness as I normally have soreness after receiving flu shots and other injections. However, I was very surprised as to how sore my arm really was. Fortunately, when I woke up the next day, January 10th, the pain had mostly subsided, with just a little swelling evident at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Venlafaxine (150 mg/day) Losartan (50 mg/day) Docusate (100 mg/night) Clonazepam (2 mg/night) Cholecalcif (10 mcc/day),None,"PTSD: Depression, high anxiety, etc.",,Penicillin Melatonin supplement ingredients,"['Discomfort', 'Injection site pain', 'Injection site swelling']",1,MODERNA,SYR 932879,CA,32.0,F,"Headaches/migraines lasting 20 hours, feeling unwell, tiredness, nausea, vomiting, sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,SEN,,,,,,"['Fatigue', 'Headache', 'Malaise', 'Migraine', 'Nausea', 'Pain in extremity', 'Vomiting']",1,MODERNA,SYR 932880,MA,49.0,M,"12/24/20 at 4am I had chills then I reported to work by 7am I had chills and body aches, had headaches & fevers my highest fever was at 8:30am of 102.3. I also experienced mild vertigo, swelling on the injection and a sore left arm also I felt fatigue. Recovered 24hours later on 12/25/2020",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,losartan potassium 50 mg once a day Cresor 10mg Metformin Hcl 500mg twice a day,No,High blood pressure Type 2 diabetes,,None known,"['Chills', 'Fatigue', 'Headache', 'Injection site swelling', 'Pain', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vertigo']",UNK,MODERNA,SYR 932882,CA,36.0,F,"Two minutes after: facial and hand tingling, dizziness. Progressed to intense nausea, diaphoresis, tachycardia, hypertension.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Paxil 30mg ER once daily at bedtime Magnesium 200mg capsule at bedtime,None,None,,"IV contrast: vomiting IV benadryl: tachycardia, muscle clonus","['Dizziness', 'Hyperhidrosis', 'Hypertension', 'Nausea', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 932883,TX,42.0,F,PATIENT HAD SIGNIFICANT SWELLING AND PAIN IN THE LEFT SIDE OF HER BODY INCLUDING HER FACE. THIS LASTED FOR 5 DAYS BUT THE PATIENT TOOK A 7 DAY COURSE OF STEROIDS TO TREAT.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/01/2021,3.0,PHM,,,,,,"['Pain', 'Swelling']",1,MODERNA,IM 932884,AZ,42.0,M,Client reports covid19 symptoms: fever/ chills /headache/elevated Blood glucose/weakness/confusion/itching/shortness of breath,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,"Apixaban 2.5 mg Tab 2x a day Azelastine 0.1% nasal spray Carboxymeth 0.5% OPTH Dulaglutide 0.7ml INJ,PEN Selenium Sulfide 2.5% Shampoo/lotion Ammonium Lactate 12% lotion Metoprolol Tartrate 50 mg 2x a day Vitamin B complex 1X a day Ipratr",CoVId19 Positive 12/14/2020,Alcoholic fibrosis & Sclerosis of liver Anemia of chronic liver disease Anxiety Breathing related sleep disorder Cardiac Pacemaker in situ Chronic alcoholism in remission Coronary artery bypass grafts x3 Coronary atherosclerosis Dependence on hemodialysis - end stage renal disease Type 2 Diabetes Mood disorder- anxiety - depressive disorder Essential hypertension Hypothyroidism History of myocardial infarction - atrial fibrillation hyperlipidemia,,none known,"['Acquired diaphragmatic eventration', 'Asthenia', 'Blood glucose increased', 'COVID-19', 'Chest X-ray abnormal', 'Chills', 'Confusional state', 'Dyspnoea', 'Headache', 'Influenza virus test negative', 'Pruritus', 'Pyrexia', 'Respiratory syncytial virus test negative', 'SARS-CoV-2 test positive']",UNK,MODERNA,IM 932885,NY,64.0,F,"Chills , Cold Sweats",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2020,01/07/2021,366.0,PVT,"B-12 ,Probiotic , Levothyroxine",None,"Thyroid , High Blood Pressure",,Azithromycin,"['Chills', 'Cold sweat']",1,MODERNA,SYR 932886,CO,51.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA I woke on the 18th with extreme fatigue and nausea, fell asleep twice during the day while sitting on the couch. Lessened and became just tired by Sunday Dec 19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,armour thyroid escitalopram,cold approx 2-3 weeks earlier,asthma,,"latex, bananas, kiwi, aspirin","['Fatigue', 'Nausea']",1,PFIZER\BIONTECH,IM 932887,NC,19.0,F,"Patient states ""hurting all over."" Temperature went from 98 degrees to 99 degrees. Her blood pressure was normal when checked twice. Three hours later she started having a rash around neck. Multiple times we asked her if her lips or throat was swelling. She said no. She went to urgent care-they sent her home with advice to take Benadryl or APAP.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,SEN,,,None listed,,None listed on consent form,"['Body temperature increased', 'Pain', 'Rash']",1,MODERNA,SYR 932888,CA,53.0,F,"I took the vaccine dose at 1030 a.m, I started feeling chills and fever by 9 pm same day, still having low grade fever and some cough and not too much chills. I am taking Advil two tablets OTC.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Cough', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 932890,CA,35.0,F,"About 40 minutes after my vaccine, I felt sudden onset progressive weakness of my entire left arm with spasms/fasciculations of my forearm and hand (while driving from hospital where I work as a physician to where I live). I pulled over, felt a bit dazed and was unable to use my left hand purposefully to call 911 on my cell phone, but was able to call 911 on my Watch using my right (dominant) hand. While talking to the dispatcher, my symptoms resolved (total duration a few minutes) so I requested that they not send an ambulance but instead felt well enough to drive to my hospital ED. I discussed my case with the triage RN and ED attending who felt my symptoms were related to the vaccine, with no further work up needed, given then my symptoms resolved. My vitals were stable in triage. No chest pain or shortness of breath, with normal neurological function and sensation of my left arm. Note: I was not officially checked in or seen as a patient. Sudden onset weakness and spasms of left arm (side of vaccine administration) about 40 minutes after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,"Synthroid, vitamin D, mutivitamin",None,-Hypothyroidism -Post-thyroidectomy with h/o papillary thyroid cancer -PCOS -Asthma (mild),,NKA,"['Feeling abnormal', 'Mobility decreased', 'Muscle spasms', 'Muscle twitching', 'Muscular weakness']",2,PFIZER\BIONTECH,IM 932891,WA,30.0,F,"Full day on 01/09/21-extremely sore muscles to the point of it being painful to move and breath. Extremely painful joints. Felt like there was an ice pick trying to pry them apart. Full day 01/10/21-hives and extremely itchy. Sore, not as bad as first day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,"Levothyroxine, metoprolol, Losartan, citalopram, tri-sprinter.",None,"Depression, anxiety.",,None,"['Arthralgia', 'Myalgia', 'Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,IM 932892,WA,45.0,M,"Increased bp, diaphoretic, skin turned red, pins and needle sensation, increased heart rate , swollen lower lip, nauseated, weird sensation of not feeling right almost like out of body",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,Sertraline 50 mg,No,Exercise induced asthma bad back,,None,"['Blood pressure increased', 'Erythema', 'Feeling abnormal', 'Heart rate increased', 'Hyperhidrosis', 'Lip swelling', 'Metabolic function test', 'Nausea', 'Paraesthesia']",1,PFIZER\BIONTECH,SYR 932893,ME,53.0,F,"Pain at injection site, fever, sweating and worsening headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,None,None,None,,None,"['Headache', 'Hyperhidrosis', 'Injection site pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 932894,AR,82.0,F,"strong headache, bad teeth chattering chills, nausea, aches, possible sinus drainage, cough - lasted from Friday night one week after shot until Sunday afternoon. Only reporting for your information.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/08/2021,7.0,PHM,"clonozepam, latanaprost, metoprolol, vitamin D, calcium, glucosomine chrondrotin, multi-vitamin",none,stomach issues due to ulcer,,none,"['Chills', 'Cough', 'Headache', 'Nausea', 'Pain']",1,MODERNA,UN 932895,MA,60.0,F,"Woke up with a red itchy face. I take zyrtec so I just decide to wait and see. It was red and pin point rash on my upper cheeks Saturday. On Sunday the rash and itch moved to my chin. Not really concerned, just documenting.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,"Bactrim (3 doses) have taken before , no reaction. Effexor 75mg, topomax 25mg, Synthroid 75mcg.",No,No,,Reglan,"['Erythema', 'Pruritus', 'Rash']",1,MODERNA,IM 932896,,25.0,M,Rash underneath injection site 8 days afterwards,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/10/2021,9.0,PHM,None,None,Bicuspid aortic valve,,Nkda,['Injection site rash'],1,MODERNA,SYR 932897,WA,39.0,F,"Fever, chills, sweats and severe debilitating deep joint pain starting around 13hrs after vaccination and lasting for 36hrs, although moderate to severe joint pain has persisted",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Zyrtec, Fluoxetine, Adderall XR, ibuprofen",None,"Multiple epiphyseal dysplasia, ADHD, well controlled anxiety, seasonal allergic rhinitis",,Anaphylaxis to latex and tilapia fish,"['Arthralgia', 'Asthenia', 'Chills', 'Hyperhidrosis', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 932898,PA,61.0,M,The patient had an apparent cardiac arrest on 12/23/20 and was admitted to the ICU. He was taken off of life support on 12/30/20. He had known cardiac disease.,Yes,12/30/2020,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/23/2020,6.0,PVT,"Amlodipine, Atorvastatin, Xarelto, Aspirin (These were medications listed with our office in 2019. Unknown if this patient was still taking at time of vaccination).",,High blood pressure. Congenital unicuspid aortic valve s/p aortic valve replacement 2001 & 2011. Pacemaker placement 2011. Melanoma,,None known.,"['Cardiac arrest', 'Cardiac disorder', 'Intensive care', 'Withdrawal of life support']",1,PFIZER\BIONTECH,IM 932899,TX,27.0,M,"On day 9 post vaccine, he developed a warm, red rash on his L deltoid. It was swollen compared to the other deltoid. It was redness 2x2 inches on L deltoid and itching on L upper extremity with one localized bump on L forearm. On 1/10 at 1 AM, he took Benadryl and applied hydrocortisone to the area. Upon waking up on 1/10 at 1 pm, his itching and rash had spread to both arms, back of neck, ears, and various spots along his forearm. He is having some irregular breathing, but could be due to nerves.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/09/2021,9.0,PVT,Tylenol 1000 mg,None,none,,Allergic to contrast dye and avocado,"['Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Irregular breathing', 'Pruritus', 'Rash erythematous', 'Swelling']",1,MODERNA,IM 932900,IN,61.0,F,"I was injected in the right arm with Moderna COVID-19 Vaccine EUA 0n 1/8/2021, 9:57 am at Clinic. I waited 15 minutes before I left the facility and okay. Did move my right arm so not to be sore. Worked regular shift: 4 pm to 10 pm and started to feel cramping. at 11:25pm, began to chill and body aches, took 2 Tylenol tablets for pain. did glucose injections : humalog: 38 units and Toujeo 54 units ( glucose was 257). Regular medications: Lisinopril 40 mg, Atorvastatin 40 mg, metoprolol 25 mg, Spironolactone 25 mg and Meloxicam 7.5 mg. Went to bed at 11:45 pm, with 3 extra blankets and winter pajamas. Woke at 1:30 am with hot flash (thinking fever) Could not find Thermometer, still had aches and pains, nausea, headache and fatigue. Contacted staff on call and replacement for Saturday shift. Went to 24 hour pharmacy and purchased a digital thermometer. I did have elevated temperature. I usually rate normal temperature of 96 to 97.7 and temperature was at 99 when taken at 3 am in the morning. Temperature remained below 99 when taken on Saturday. Rested and ate properly, maintained good glucose readings. Returned to work on Sunday morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,none. AM medications taken at 7:30 am.,"Tested negative for Covid-19 on December 3, 2020 by blood work requested by Dr., Internal Medicine. Came in contact with a person served with Covid-19 on December 6, 2020 and was caretaker for dying mother. I tested a second time, this time swab from Dr.'s office and positive on 12/11/2020. Mother tested positive for Covid-19 on 12/13/ 2020. Tested 2nd time for Covid-19 was Positive. Mother passed away December 22, 2020 with Covid-19.",Heart disease Fatty Liver Type 2 Diabetes (2006 to present) Kidney disease Obesity,,"Medications: Metformin, Crestor","['Blood glucose increased', 'Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Hot flush', 'Increased insulin requirement', 'Muscle spasms', 'Nausea', 'Pain']",1,MODERNA,IM 932901,,52.0,F,"Turned red in upper torso, swelling to tongue and heightened blood pressure.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,WRK,"Levothyroxine, Metopropolol Succ, Amldipine Beysylate, Pravastatin",None,Hypertension and high cholesterol,,Apples and similar tree fruits,"['Blood pressure increased', 'Rash', 'Swollen tongue']",2,PFIZER\BIONTECH,IM 932902,AZ,50.0,F,"Within 15 minutes of vaccine administration, I developed difficult swallowing, scratchy throat and severe flushing of face, neck and chest. This lasted about 1.5 hours. Symptoms resolved within 2 hours. Treated with oral Benadryl and Tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,"Tylenol, meloxicam, methocarbinol, lyrica, cymbalta, levothyroxine, tramadol, tizanadine, vitamin d, fexofenadine, ventolin inhaler",Right eye stye Flu like symptoms 2 weeks ago- Covid -,Fibromyalgia Asthma Osteoarthritis Hypothyroidism Migraine,"Fluarix flu vaccine- 2 yrs ago, had diarrhea, stomach pain and headache for 2 weeks consistently following receipt of vaccine","PCN, Latex, Mangos, sulfa drugs, Bee stings","['Dysphagia', 'Flushing', 'Throat irritation']",1,PFIZER\BIONTECH,IM 932903,WV,53.0,F,"1/8/21- within a few minutes of vaccine administration: Dizziness, lightheaded, confusion/disoriented, tingling in hands and feet, blood pressure issues, pale, cold limbs, warm trunk/head. 1/2/21- approximately 1:00pm- developed headache. 1/9-1/10/21- joint pain/muscle pain/headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,SCH,mobic 15mg metanx 15mg neevo DHA Zovia 1/35E Plaquenil 400mg levothyroxine 150mg aspirin 81mg vitamin d3 2000 iu vitamin C 1000mg Ambien CR 6.25 Intermezzo 1.75 sublingual Zinc 50mg Black Elderberry 1000mg,none,Lupus Hypothyroidism/thyroid nodules Kidney Stones Complex Regional Pain Syndrome (CRPS) Neuropathy Endometriosis/adenomyosis,"Muscle wasting, age39, 2006, Tdap vaccine (all other information unknown)",conray 60 contrast dye penicillin/amoxicillin/augmentin trileptal trazadone tetanus allergic to bee venom,"['Arthralgia', 'Blood pressure fluctuation', 'Confusional state', 'Disorientation', 'Dizziness', 'Headache', 'Myalgia', 'Pallor', 'Paraesthesia', 'Peripheral coldness', 'Skin warm']",1,MODERNA,SYR 932904,WI,35.0,F,Acute Appendicitis which occurred 84 hours after injection of the Moderna covid vaccine #1. Presented with right abdominal pain and required removal of appendix.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/09/2021,3.0,PVT,"Vitamin D3, Tranexamic Acid",none,Multiple Sclerosis,,"Sulfa, PCN, Amoxicillin","['Abdominal pain', 'Appendicectomy', 'Appendicitis', 'Computerised tomogram abnormal', 'White blood cell count increased']",1,MODERNA,SYR 932905,GA,64.0,F,"Fever, chills, muscle aches, headache, brain fog Started 10 hours after vaccine administration, lasted 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PUB,"Estradiol patch, Detrol LA 4 mg, bupropion XL 300 mg",None,Urinary urgency,,None,"['Chills', 'Feeling abnormal', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 932906,IN,38.0,F,"Chills, joint pain, fatigue, local reaction. Benadryl, ibuprofen q6h",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Breo, Singular, Zoloft, prenatal, dymista, Dexilant",,asthma,,"Azithromycin, Bee's","['Arthralgia', 'Chills', 'Fatigue', 'Injection site reaction']",2,PFIZER\BIONTECH,IM 932907,KS,24.0,F,"first day of receiving it, I had a headache and was drowsy four days later I woke up to vomiting and diarrhea, I was shaking. I was freezing but sweating. This lasted 24 hours. a week and a day my injection site had become irritated as well was it felt as though some one was burning me with a hot iron. this never happened until 1/8/2021. a week and two days later I had severe diarrhea, headache and was nausea all day. This was on 1/9/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/10/2021,10.0,PUB,"Levothyroxine, Sertaline, and birth control",,Hypothyroidism,,,"['Diarrhoea', 'Feeling cold', 'Headache', 'Hyperhidrosis', 'Injection site irritation', 'Injection site pain', 'Nausea', 'Somnolence', 'Tremor', 'Vomiting']",1,MODERNA,IM 932908,OK,39.0,F,"Fever, chills, vomiting, abdominal pain, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Singulair, plaquenil, vitamin D, protonix",,"Rheumatoid Arthritis, Asthma",,Sulfa,"['Abdominal pain', 'Chills', 'Headache', 'Pyrexia', 'Vomiting']",UNK,PFIZER\BIONTECH, 932909,OH,48.0,M,"Initially, I felt fatigued and my left deltoid was sore. On day three after vaccination, I had one episode of hematuria. On day 4, I developed a fever and chills. On day 5, I developed dysuria, urinary frequency, urgency and hesitancy. I have also had some low back pain and purulent urine. I have never had any urinary or prostate issues in the past and have regular annual physical exams. I am an emergency physician and had to work, so I started myself on Bactrim DS (I am avoiding floroquinolones due to numerous black box warnings). I have had several other episodes of hematuria during my treatment. I am on day 13 of Bactrim and my symptoms are improving. I am not sure if this is a coincidence, but I have never had any similar issues and thought this should be reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/25/2020,2.0,PVT,"Synthroid 150mcg, sertraline 50mg",None,Hypothyroidism,,None,"['Back pain', 'Chills', 'Dysuria', 'Fatigue', 'Haematuria', 'Injection site pain', 'Micturition urgency', 'Pollakiuria', 'Pyrexia', 'Pyuria', 'Urinary hesitation']",1,MODERNA,IM 932910,ME,35.0,M,"I received the Moderna Vaccine first dose. Within a minute of receiving the vaccine, i became dizzy, tachycardic and experiencing hot flashes. Me thinking it was in my head did not say anything i waited the 15 minutes and left the vaccination area. The feeling i got seemed to go away and i thought everything was good and was my way home. About 30 minutes after injection i began experiencing itching in the face, nausea, dizziness, i was pale as a ghost. Having felt this before it was just like my allergic reaction i get when i ingest shellfish. I stupidly continued on my way home when i should have went to an ER but nonetheless i made it home and took some benedryl about 30 minutes later my symptoms subsided. I also took my blood pressure when i arrived home and was hypotensive. By the next day was fully recovered and no problems since day of injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,None,None,None,,"Shellfish, Sulfa antibiotics","['Dizziness', 'Hot flush', 'Hypotension', 'Nausea', 'Pallor', 'Pruritus', 'Tachycardia']",1,MODERNA,IM 932911,LA,57.0,F,Redness at injection site only. The area of redness was 4 inches by 5 inches at the largest point. The red area began to get smaller on 1/9/21. The patient did not report any other adverse reaction to the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PHM,,,,,,['Injection site erythema'],1,MODERNA,IM 932912,NY,43.0,F,"fever, chills, nausea, fatigue, joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,"Synthroid, olopatadine eye drops, flonase",none,mixed connective tissue disease,,"Hazelnuts, macadamia nuts penicillin, erythromycin, clindamycin, amoxicillin","['Arthralgia', 'Chills', 'Fatigue', 'Nausea', 'Pyrexia']",1,MODERNA,IM 932913,TX,57.0,F,"Local Redness, Warmth induration, and itching at injection site started yesterday (10/07) 5 days after receiving first vaccine dose",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/08/2021,6.0,UNK,,,,,latex,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,SYR 932914,FL,49.0,M,"RECEIVED DOSE AT 1;17 pm 1/7/2021. At 9pm 1/7/2021, muscle aches, fatigue, fever (100.4F) and shaking chills began. waxed and waned throughout 01/08/2021 and finally ended approximately 05:00 Saturday 01/09/2021. I have felt totally fine since then. I received the first dose 12/17/2020 in my left arm at 1230pm. I had no side effects except for paining some swelling in the deltoid muscle that lasted a day or so. I get the full vaccine every year and never have any sort of reaction, even a mild one. I am a physician and understand the purpose of the vaccine and how it works.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,anastrozole 1 mg every other day po,none,none,,cutaneous allergy to zinc,"['Chills', 'Fatigue', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Pyrexia', 'Tremor']",2,PFIZER\BIONTECH,IM 932915,WA,25.0,F,"Severe thrombocytopenia (plts 3k/uL), oral mucosal bleeding, bruising",Not Reported,,Yes,Yes,3.0,Not Reported,N,12/29/2020,01/08/2021,10.0,PVT,"Zoloft (sertraline), vitamin D, cetirizine (zyrtec)",None,"Anxiety, history of anti-thyroglobulin antibodies",,None,"['Contusion', 'Haematocrit normal', 'Haemoglobin normal', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Mouth haemorrhage', 'Platelet count decreased', 'Red blood cell count normal', 'Red cell distribution width normal', 'Thrombocytopenia', 'White blood cell count normal']",1,MODERNA,IM 932916,WI,30.0,M,"9 hours post-vaccine, developed rigors, fever to 102.7, myalgia, headache, and nausea. Everything but fever resolved within 18 hours. Fevers resolved by 48 hour mark.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,None,None,Vitiligo,,None,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932917,CO,51.0,F,"1/7/2021 at 1230 I began experiencing SOB, assumed it was asthma, 2 puffs of albuterol taken. At 1330 still SOB with chest pressure/tightness, no change, no cough, no feeling appropriate, 2 puffs albuterol. At 1415 reported to the vaccination clinic and told them of symptoms, SOB with movement, and general pressure in the chest. 2 Tylenol taken. I was required to check into the ER for Observation. oxygen saturation checked for 2 hours. no change in symptoms, no worsening. I then left work in the ER and went home. At approx. 1800 ate dinner, no real taste, but needed to eat. At 1830 showered, 2000 to bed, just feeling malaise. continued pressure in the chest and general soreness. 2 Tylenol Through the night I slept very poorly, tossed and turned, woke frequently. Body and joints with extreme pain everywhere it touched the mattress. I have a screw in my left foot, it felt like it was on fire at some point during the night. My left leg ached up into my hip. On the morning of January 8, woke approx 0800 with a temperature of 99.9, pain in all my joints, back and up into neck, headache, and nausea. Took 2 Tylenol, 3 ibuprofen, and 4 mg Zofran. 1200 symptoms began to lessen and felt like I had the flu, still sore, but less severe. 1300 - 2 Tylenol Slept better, just sore January 8 night. January 9 - 2 Tylenol in the morning, sore everywhere, right arm site sore, headache, eye pain, intermittent nausea. 2 more tylenol around 1800 January 10, 2 tylenol 0900, remain sore but lessening, headache and eye pain continues, intermittent nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,armour thyroid escitalopram,reaction to vaccination #1 with fatigue,asthma,fever 99-103 through out my life with all my vaccinations,"latex, banans, kiwi, aspirin","['Ageusia', 'Arthralgia', 'Chest discomfort', 'Dyspnoea', 'Eye pain', 'Headache', 'Malaise', 'Nausea', 'Pain', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 932918,IL,44.0,F,Injection site soreness the following day. That is the only adverse reaction I have experienced thus far,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,None,None,Hypertension Hypothyroidism,Pfizer shot 1- same effect,None,['Injection site pain'],2,PFIZER\BIONTECH,IM 932919,NJ,53.0,M,Fever to 101.7 with chills and muscle aches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932920,UT,66.0,M,"Seizure occurring at 0700 in dining room, 1 episode, unresponsive for 2 minutes, after episode experienced general weakness then shortly was able to walk after, vitals stable after",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,SEN,Tylenol 650 mg PRN,"Chronic Kidney Disease Stage 3, Alzheimers, Hospice patient","Chronic Kidney Disease Stage 3, Alzheimers, Hospice patient",,None,"['Asthenia', 'Seizure', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 932921,VA,28.0,F,"I am early pregnancy- I haven't even had an ultrasound yet to calculate an exact due date. I am approximately 6 weeks. About 12 hours after receiving the vaccine I became ill with body aches, chills, nausea, vomiting, general malaise and headache. I was sick until approximately 1530 on 1/10.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,UNK,Pre-natal vitamins,Early pregnancy (approximately 6 weeks),None,,Nkda,"['Chills', 'Exposure during pregnancy', 'Headache', 'Malaise', 'Nausea', 'Pain', 'Vomiting']",2,PFIZER\BIONTECH,IM 932922,FL,51.0,F,"On day 8, developed itchiness and then redness and swelling at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/10/2021,8.0,PVT,Zyrtec,None,None,Pain in arm next day,"Amoxicillin, codeine","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 932923,,58.0,F,Heart Palpitations--very frequently at times with felling of not being able to catch my breath,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,UNK,,,,,,"['Dyspnoea', 'Palpitations']",1,MODERNA,IM 932925,MN,52.0,M,"received his first dose of the Covid vaccine 1/6. Since that time he has endorsed fatigue, body aches, headache, and nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/08/2021,2.0,PVT,,,DM2,,,"['Fatigue', 'Headache', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,IM 932926,CA,38.0,F,"Three days after receiving first vaccine, I woke up with fasciculations in my left lower lip. The twitching was visible standing 2 ft from my mirror. It lasted approx 30min then spontaneously resolved. No other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/10/2021,3.0,PVT,"Wellbutrin XL 150mg qd Zyrtec 10mg qd Melatonin 3mg QHS PRN Ibuprofen PRN Vitamin C, D, zinc",none,Raynaud's phenomenon Seasonal allergies,,NKA,"['Muscle contractions involuntary', 'Muscle twitching']",UNK,PFIZER\BIONTECH,IM 932927,CT,47.0,F,"12/31/2020 later that night my whole left side went numb left arm, fingers, foot, lips, tongue. I took benadryl 50mg. The next day was still numb on and off took benadryl 50mg. The morning of 01/02/21 called the covid vaccine hotline and directed me to go to the ER. I went that day to Saint Rachael's and was given steroids and sent home. I picked up a prescriptions for steroids 60mg 3xtimes a day and had EPI pen as well. So, after taking the steroids prescription i was starting to feel some numbness on the left arm again. And it continues with pain on the site of injection and some numbing.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,WRK,"Multi vitamin, b12, probiotic, calcium",Nonenone,None,,Adhesive,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Injection site hypoaesthesia', 'Injection site pain']",UNK,MODERNA,SYR 932928,NC,40.0,M,"PAIN, TENDERNESS AND SWELLING OF THE LYMPH NODE AT LEFT SIDE: ABOVE CLAVICLE BONE, LOWERSIDE OF LEFTSIDE NECK AREA.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,PUB,none,NONE,NONE,,NONE,"['Lymph node pain', 'Lymphadenopathy']",UNK,MODERNA,IM 932929,MD,33.0,F,"Erythema, swelling, and itching to area around injection site which spread over entire upper arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/08/2021,7.0,UNK,"Nuca ring, vyvanse, multivitamin",None,"GAD, ADD",,Penicillin as a child,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA, 932930,FL,49.0,M,"I received the vaccine at 1;17PM on 01/07/2021.. At 9pm I experienced muscle aches, fatigue, chills and a fever (100.4F). These symptoms waxed and waned over the next 32 hrs. At 5am, on 1/09/2021, my symptoms resolved. Since then, I am completely fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,anastrozole 1 mg every other day po,none,none,,cutaneous allergy to zinc,"['Chills', 'Fatigue', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932931,NY,38.0,F,"Same day of injection: general malaise and tiredness within 2 hours of shot Day 2: malaise and tiredness lessened, but incredible soreness to injection site (left deltoid) Day 3: moderate diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,none,none,none,,none,"['Diarrhoea', 'Fatigue', 'Injection site pain', 'Malaise']",1,PFIZER\BIONTECH,IM 932932,SC,19.0,F,Fever Chills Diarrhea Headache Sore body Stuffed nose No taste or smell Lasted all for 9 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,Advar and proair,No,Asthma,,No,"['Ageusia', 'Anosmia', 'Chills', 'Diarrhoea', 'Headache', 'Influenza virus test negative', 'Nasal congestion', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Streptococcus test negative']",1,PFIZER\BIONTECH,SYR 932933,NC,58.0,F,Fever over 102 that did not respond to Tylenol or Motrin. Remained with elevated temperature until the next morning.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PUB,Levothyroxine,None,Hyperthyroidism,,NKA,['Pyrexia'],1,MODERNA,IM 932934,IN,31.0,F,"Fever 101.8, chills, nausea, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PUB,"Multivitamin, cetirizine, flonase",None,None,,Penicillin,"['Chills', 'Malaise', 'Nausea', 'Pyrexia']",1,MODERNA,IM 932935,CA,32.0,F,"G2, P1. 21 weeks 2 days at time of vaccination, due 5/19/20. Est fetal weight approx. 15.7ounces as of 1/6/20. Mild arm soreness, onset approximately 5 hours after vaccine. Subsided within 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Folic acid, prenatal vitamins",None,None,,,['Pain in extremity'],1,PFIZER\BIONTECH,IM 932936,NJ,49.0,F,"Immediately started feeling hot nose became numb , couldn't swallow , tingling of extremities . 2-3 hours after a fever of 100.5 . Weird sensation in face .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/10/2021,0.0,PVT,Plaquenil Metformin Singular Simvastatin Aspirin Dexilant Probiotic Bio cleanse Oregano Lysine D B C Immunopower,Covid 11/5/20 lasted 2 weeks then penuemonia,Lupus Sjogrens PCOS Gastritis Insulin resistance GERD Grovers,Flu shot in 1995 led to ER visit,Penicillin Oyster Scallop Iodine Morpheme Codeine Percocet,"['Dysphagia', 'Immediate post-injection reaction', 'Paraesthesia', 'Pyrexia', 'Skin warm']",UNK,MODERNA, 932937,PA,24.0,F,Shot on 1/9/21 at 10:10 am. Body aches 1/9/21 from 12:30-2:30pm. Relieved with naproxen 500mg and sleep.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Fluoxetine 60 mg daily Adderall XR 10 mg daily,None,"Anxiety, depression, ADHD",,None,['Pain'],1,MODERNA,IM 932938,TN,46.0,F,Itching and hives.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,"Methimazole 15 mg daily, daily multivitamin for women. Immediately after the receiving vaccine too Ibuprofen 400 mg (2 x 200mg) that was offered.",None.,"Graves' Disease, Migraine headaches.",H1N109,"Shrimp, Iodine contrast dye, Fentanyl, H1N1'09.","['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 932939,GA,62.0,F,"nausea, chills ,temp of 101.3, exhaustion, upper breast lymph nodes painful , loss of taste & smell - occurred over 1 week time frame",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,fish oil D3 B-Complex,none,none,,intolerance to wheat,"['Ageusia', 'Anosmia', 'Body temperature increased', 'Chills', 'Fatigue', 'Lymph node pain', 'Nausea']",1,MODERNA,SYR 932940,WA,45.0,F,"on day of injection approx 13 mins after injection RN was called to her car. She reported throat tightness, and dizziness 911 was called and pt was monitored until symptoms improved. Was not transported to ED. 2 days later developed a hive like rash and was seen at walk in clinic was treated with prednisone.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,PVT,,,Asthma,,"bee venom, Kiwi, penicillin's, Bactrim, doxycycline, propoxyphene, ceclor, Flagyl","['Dizziness', 'Rash', 'SARS-CoV-2 test negative', 'Throat tightness', 'Urticaria']",2,PFIZER\BIONTECH,IM 932941,UT,53.0,F,"Day 1- Almost immediate response (<~5 minutes) Tingling R fingers ; tingling tongue; slight numbness R arm & slight facial numbness, metallic taste in mouth Later Day 1 afternoon and evening - heart palpitations; metallic taste in mouth. Usual & expected solicited SEs: fatigue, soreness, feeling ""off,"" transient headache, chills sx Day 2- strong R arm pain, cannot lift R arm. Metallic taste in mouth and tingling tongue persists. Also same usual Sx as day 1 plus mild nausea. Felt really crummy. Day 3- Still moderately strong R arm pain, can only partially lift arm over head, cannot straighten over head. Strong fatigue continues, mild nausea. By this day I recall having some unusual Noc . calf cramping. Sx certainly improved after 72 hrs but some did continue up to 7 days. Cramping returned as did odd R ear/jaw/throat nerve pain. Scratchy throat. Fatigue persisted, gradually improved. I believe the non-standard SEs may represent an allergic reaction. I deem this mild to moderate, as I was unable to perform daily functions at times. I would like to be able to talk to a professional as to whether a second dose is recommended in my situation. I am concerned to know if previous allergic reactions suggest increase likelihood of future and possibly worsened reactions. Note: I have been unable to access my Vsafe reports today to confirm exact time frame. The above is to best of my recollection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,"Propanalol 20mg PRN. Occasional use of milk thistle, standardized silymarin extract 300 mg",No known illnesses at time of vaccination.,Multiple chemical sensitivity. PTSD.,,"No significant allergy history. No history of anaphylactic reaction to food, bees, etc. History of multiple chemical sensitivity. Medication sensitivity, dose dependent.","['Chills', 'Dysgeusia', 'Ear pain', 'Fatigue', 'Feeling abnormal', 'Headache', 'Hypoaesthesia', 'Injected limb mobility decreased', 'Joint range of motion decreased', 'Loss of personal independence in daily activities', 'Muscle spasms', 'Nausea', 'Neuralgia', 'Oropharyngeal discomfort', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Pain in jaw', 'Palpitations', 'Paraesthesia', 'Paraesthesia oral']",UNK,MODERNA,IM 932942,CA,63.0,M,"Developed chills and fever approximately 12 hours after shot. As I had the Covid 19 in May, (tested negative on the 18th May, positive on 21st May) the symptoms are very similar. Except for no loss of smell or taste. Moderate to extreme fatigue at this point 72 hours later seem to be the only lingering effects with some light headedness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,"Levothyroxine, Simvastatin, Colchicine",None,"High Cholesterol, Gout, Hypothyroidism",,None,"['Chills', 'Dizziness', 'Fatigue', 'Pyrexia']",1,MODERNA,IM 932943,NY,56.0,F,"Moderna COVIS-19 Vaccine EUA - adverse reactions started 7 hours after administration (7pm) on 1/7/21. Severe Chills, Shakes and could not get warm, but no fever until midnight, 100 degrees), when I took 2 NyQuil and went to bed. 6am next morning, no fever but still felt achy and weak. Took naproxen at 2:15. Still achy and temp was up to 100.6 at 4pm and took 600 mg ibuprofen. Temp up to 100.8 at 5:20 and took 1000mg of acetominophen at 5:20. Took Nyquil and went to bed around 10pm. Second morning temp was 99.4 and never went up after that. Tired and achy most of the day but a switch flipped around 4pm and I felt back to normal. Today was day 3 after injection and feeling 100%. Vaccine side affects were worse than when I had COVID in July but will do it again in a month.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Losartan, Multi vitamin, Vit C, Fish oil, glucosamine and chondroitin, Tumeric",None,Mitral valve regurgitation,24 hours flu like symptoms after second dose of shingles vaccination this past fall at 56 years old. Unsure which brand but it w,Lisinopril cough,"['Asthenia', 'Chills', 'Fatigue', 'Feeling cold', 'Pain', 'Pyrexia', 'Tremor']",1,MODERNA,IM 932944,KS,30.0,M,"20 hours after injection, I started having progressively worsening severe back pain, neck pain, headache, chills (no fever), skin sensitivity, noise sensitivity, fatigue, and brain fog. 2 days after the vaccine, I had abdominal pain, and cough. All of that is now better except for the cough. It is now 4 days after the vaccine, and it seems the vaccine has triggered an asthma attack requiring inhaled albuterol. My asthma attacks typically linger for a couple weeks after upper respiratory infections, and this feels exactly like that, I wouldn?t be surprised if this asthma attack persists for a couple of weeks.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,Cetirizine,None,"Seasonal allergies (controlled with over the counters), asthma (controlled without medications. It only flares up on average once a year when I get an upper respiratory tract infection).",Body aches and fatigue after first Pfizer Covid vaccine dose on 12/17/2020 LOT Number EH9899,Sulfa,"['Abdominal pain', 'Asthma', 'Back pain', 'Chills', 'Condition aggravated', 'Cough', 'Fatigue', 'Feeling abnormal', 'Headache', 'Hyperacusis', 'Neck pain', 'Sensitive skin']",2,PFIZER\BIONTECH,IM 932945,CA,33.0,F,"Swollen, tender axilla of right arm. Same arm as injection. The swelling started a few hours after vaccine administration and remains unchanged. The area is still swollen, tender and right arm has little range of motion. Currently taking tylenol and motrin for pain. Submitting request for primary MD appointment to assess area but have not been seen by healthcare professional related to issue as of 1/10.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Birth control, daily multivitamin",none,Benign prolactinoma,,Pediazole,"['Lymphadenopathy', 'Mobility decreased', 'Tenderness']",2,PFIZER\BIONTECH,IM 932946,NJ,47.0,F,"Headache, body aches, malaise, chills, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Vitamin D, vitamin b complex",None,None,,None,"['Chills', 'Headache', 'Malaise', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932947,OH,56.0,F,"Tired and Chills for about 12 hours Bruising, redness and swelling lump 3?x4? under skin Lump the size of ?half boiled egg? under skin on left arm Holding heat **I would like to note I have NEVER had a reaction to any immunization prior and have received flu vac every year, Series of Hep B vac, pneumonia and shingles",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PUB,"Metformin, Wellbutrin, Rovastatin, losartin, amolodione add in blood pressure med, doc sod stool softener, nortriptiline,",Uti,"Diabetes type 2, high blood pressure, fibromyalgia",,Cephlexin antiobiotic,"['Chills', 'Contusion', 'Erythema', 'Fatigue', 'Mass', 'Skin warm', 'Swelling']",1,MODERNA,SYR 932948,KS,40.0,M,Bells Palsy approximately 24 hours after vaccination. I presented to the ER for evaluation. I was treated with steroids and antivirals for 7 days. Symptoms ave still persisted to date.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/28/2020,1.0,PVT,None,None,None,,None,"[""Bell's palsy"", 'Computerised tomogram head', 'Laboratory test normal']",1,MODERNA,IM 932949,OK,66.0,F,"1/9/2021 fever of 101.3, chills, 1/10/2021 fever 99.6, diarrhea, pain in injection site slight. Tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,OTH,Tylenol,None,CHF,,Tape,"['Cardiac failure congestive', 'Chills', 'Diarrhoea', 'Injection site pain']",UNK,MODERNA,SYR 932950,NJ,31.0,F,"First dose resulted in shoulder injury. Severe arm pain began evening after the first dose, followed by pain in the shoulder joint when raising arms above head which has persisted for 23 days. Second dose resulted in fever, chills, nausea, swelling of hands and flushing sensation in hands/feet, with maximum fever of 100.2 F documented 24 hours after the second dose. Fever and chills resolved about 36 hours after the injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,WRK,Escitalopram,,,,"Penicillin, bee stings","['Arthralgia', 'Chills', 'Flushing', 'Limb injury', 'Nausea', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932951,NY,50.0,F,"Freezing/chills, temp between 102 and 100 degrees, sweating, really bad headache, dizziness, nausea, wheezing, pain at the injection sight, couldn't stay awake. No treatment was unable to get out of bed for almost 12 hours. Temp at 100 now",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,OTH,"Gabapentin, furosamide, tiadylt, cetirizine, omeprazole, fluconazole, wixela",None 1 month prior,High blood pressure Allergic asthmatic Gerd,,"Environmental allergies, shellfish, soy, wheat, bananas, oranges","['Asthma', 'Body temperature increased', 'Chills', 'Dizziness', 'Feeling cold', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Mobility decreased', 'Nausea', 'Somnolence', 'Wheezing']",UNK,MODERNA,SYR 932952,CA,58.0,F,Hives on both arms upper torso Benadryl every 4 hours is planned,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/10/2021,2.0,WRK,Lopressor Bupropion MVT Tumeric Hair skin and Nails Calcium Osteo bi flex,Na,HTN Obesity,,Nkda,['Urticaria'],1,PFIZER\BIONTECH,IM 932954,OH,65.0,F,"Fever, body aches, vomiting, diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Citolpram, low dose aspirin, valsartarin, luvothtoxin",None,"SVT, COPD",,"Shell fish, bee string, lisinopril, ibuprofen.","['Diarrhoea', 'Pain', 'Pyrexia', 'Vomiting']",UNK,MODERNA,SYR 932955,VA,44.0,F,"I had throat & tongue swelling in the 15 mins after 1st covid vaccine/moderna..... EMS walking me out of school to ambulance & I passed out on sidewalk. And even I could not talk due to throat and tongue swelling and was getting weak. I was checked BP , it was over 150. I was transported to LG Alleghany - I received 1 epipen at the ambulance and another epipen in the ER. total got 2 Epipens. --- heart racing & shaking all over -- At the ER, took x-ray on lung and thorat , did EKG, and got Benadrly then slept for 40 mins or 1 hour.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,SCH,"Vitamin C 1000mg, Tylenol 500mg",None,None,,None,"['Aphasia', 'Asthenia', 'Chest X-ray normal', 'Electrocardiogram', 'Face and mouth X-ray normal', 'Loss of consciousness', 'Palpitations', 'Pharyngeal swelling', 'Swollen tongue', 'Tremor']",,MODERNA,IM 932957,,60.0,F,"Hives, no treatments",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/30/2020,7.0,UNK,,,,,,['Urticaria'],1,MODERNA,IM 932958,SC,29.0,F,"Exquisitely tender right sided epitrochlear, axillary, and supraclavicular lymphadenopathy. Began about 16 -20 hours after receiving vaccination. Still present at 36 post vaccination, but seems to be improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,Lexapro Adderall Omeprazole Microgestin Magnesium Cetirizine Calcium/Vitamin D,N/a,"Mild seasonal allergies, ADHD, GERD",,N/a,"['Lymphadenopathy', 'Tenderness']",1,PFIZER\BIONTECH,IM 932959,MN,32.0,F,"About 5 minutes after receiving my second dose I became flush, and hot from the outside in over my whole body. I was tingly all over. I felt shaky and like I was going to pass out. Very nauseous. My blood pressure was 169/93 @ 0830. The staff had me lay down. About 5 min later I started to feel better. Another 5 min later it happened again in a wave. The symptoms just came over me. My blood pressure @ 0840 was169/104. The staff had me drink water and rest. @0900 the wave came over me again. My BP was 178/111. I drank more water and rested. BP recheck @ 0925 162/112. @940 BP was slowly coming down at 145/109. At that time they transferred me to the Emergency room. My BP came back into normal ranges, and the waves stopped happening around 12pm. I was then released home with plans to follow up with Primary care on 1/11/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,50mg Sertraline - 1 per day,,Poly Cystic Ovary Syndrome,,,"['Blood pressure increased', 'Dizziness', 'Feeling hot', 'Flushing', 'Nausea', 'Paraesthesia', 'Tremor']",2,PFIZER\BIONTECH,SYR 932960,KS,33.0,F,post vaccine day 8 developed hives that increasingly got worse through day 10. Day 10 consulted a physician who prescribed prednisone.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/07/2021,8.0,PVT,amlodipine 5mg once per day lisinopril 20mg once per day calcium + vitamin D 600mg per day womens one a day vitamins once per day.,No illnesses at the time of vaccination or prior.,High Blood pressure. No other long standing health conditions.,,"No allergies. As a kid had a hypersensitivity to many products (soaps, detergents, cleaners).","['Condition aggravated', 'Urticaria']",1,MODERNA,IM 932961,TX,65.0,M,"Elevated Blood pressure, wooziness or ""spinning"" in the head, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,"25mg Metoprolol Succinate once a day, along with a low dose aspirin and an ""Alive Brand"" vitamin.",none,none,,none,"['Blood pressure increased', 'Dizziness', 'Nausea', 'Vertigo']",UNK,MODERNA,SYR 932962,AZ,70.0,F,Sore arm and occasional headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,Multi vitamin,,COPD,,TCN,"['Headache', 'Pain in extremity']",1,MODERNA,IM 932963,ME,47.0,F,Chills and nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,UNK,None,None,Heart murmur,,Amoxicillin,"['Chills', 'Nausea']",1,MODERNA,SYR 932964,CT,32.0,F,"Left arm injected, and I have been experiencing burning of the left side of my face. The burning is not present on the right side of my face.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/10/2021,0.0,WRK,Sulfasalzine 1000mg BID Levothyroxine 112 mcg/daily Folic Acid 1 mg/daily Fish Oil Vitamin C Vitmain B12,"Hashimotos Thyroiditis, Hypothyroidism Inflammatory Arthritis","Hashimotos Thyroiditis, Hypothyroidism Inflammatory Arthritis",,NKMA,['Burning sensation'],1,PFIZER\BIONTECH,IM 932965,WI,40.0,F,After sitting down in the observation area and I was just starting to register for vsafe my heart started to pound then I experienced a hot flushed feeling that went through my entire body and my heart started racing and felt not well. I told the nurses what happened and they said I looked pale. I laid down and started to feel better after a few minutes.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Vitamin D Vitamin C,None,None,,Sulfa,"['Hot flush', 'Pallor', 'Palpitations']",1,PFIZER\BIONTECH,SYR 932966,TN,28.0,F,"Mild headache about 6 hours after then by about 12 hours after dose had profound chills, body aches, severe nausea and temperature 99.8 F. I treated the nausea with Zofran with some improvement in nausea, but other symptoms continued. My max temperature (without antipyretic affecting) was 100.7 F with continued nausea, body aches, fatigue and headache until the 24 hour after vaccine time frame. After 24 hours, nausea had improved largely to just mild, mild headache continued and fatigue/body aches. Around 28 hours, temp was 100.2 F (outside of last antipyretic dose) with same symptoms. Now around 30 hours out with recent Motrin taken, my nausea is still mild, low appetite, improved body aches and less fatigue. I have not had any site reactions other than pain starting around 6 hours after injection. Course to come yet unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,,None,Autoimmune urticaria and angioedema,,NKDA,"['Body temperature increased', 'Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 932967,IN,39.0,M,Night of the shot I had night sweats and chills. Woke up the following morning with 100 deg temperature. Experienced body aches. Temperature went away 2 days after vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Body temperature increased', 'Chills', 'Night sweats', 'Pain']",2,PFIZER\BIONTECH,SYR 932968,NJ,62.0,F,"I had a headache, chills, nausea and diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/07/2021,2.0,OTH,Gabapentin,,Diverticulitis Arthritis Herniated disc,,Ciproflaxin,"['Chills', 'Diarrhoea', 'Headache', 'Nausea']",1,MODERNA,IM 932969,UT,45.0,F,"18 hours after injection developed maculopapular rash at injection site, muscle pain at sight of injection and neck. Subsequently developed flu-like symptoms: headache, fever(101F), chills, myalgias, arthaligias, fatigue that continued daily for several weeks.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/22/2020,1.0,PVT,"Losartan, ibuprofen, tylenol, benadryl, b12 Lexapro",,"extertional hypertension, SVT, NSVT",,celebrex,"['Arthralgia', 'Blood thyroid stimulating hormone', 'Chills', 'Complement factor C3', 'Complement factor C4', 'Fatigue', 'Full blood count', 'Headache', 'Influenza like illness', 'Injection site pain', 'Injection site rash', 'Metabolic function test', 'Myalgia', 'Pyrexia', 'Red blood cell sedimentation rate normal', 'SARS-CoV-2 test negative']",UNK,UNKNOWN MANUFACTURER, 932970,TX,64.0,M,"Headache, soreness of eyes, fever, chills, mild nausea, one episode of diarrhea, fatigue, slowing of cognitive function.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,None,None,Benign Prostate Hyperplasia,"3 weeks previous, COVID-19 vaccine, 12/17/2020, similar but milder symptoms.",None,"['Chills', 'Cognitive disorder', 'Diarrhoea', 'Eye pain', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932971,NY,38.0,F,"Fever 102 with chills, body ache, headache. Fever started 24 hours post vaccination. Subsided with ibuprofen then relapsed 48 hours post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,No,No,No,,No,"['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 932972,FL,29.0,F,Moderna COVID?19 Vaccine EUA,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,HEATHER 0.35 MG TABLET METOPROLOL SUCC ER 50 MG TAB TABLET EXTENDED RELEASE 24 HR BUPROPION HCL XL 300 MG TABLET TABLET EXTENDED RELEASE 24 HR Iron Women multi vitamin,Tension headache 3-4 weeks prior,High blood pressure,,,['Unevaluable event'],UNK,MODERNA, 932973,CA,16.0,F,"on 1/9/2021 -, 16 year old female was given Moderna vaccine. 10 minutes after injection, this was discovered. Pt reports no adverse reactions during the 15 minute observation period. Telephone call on 1/10/2021 at 3:00 pm mother reports child had some arm soreness and a little dizzy yesterday but today feels fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PUB,,,,,,"['Dizziness', 'No adverse event', 'Pain in extremity', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 932977,IL,32.0,F,"Fatigue, body aches, headache, chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/10/2021,1.0,PVT,"Zyrtec, probiotic, losartan, ocella","High blood pressure, asthma","High blood pressure, asthma, IBS, high cholesterol",,"Ceclor, rocephin, dogs, dust mites, pollen, cats","['Chills', 'Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH,SYR 932978,NC,75.0,F,Pfizer-BioNTech COVID-19 Vaccine 1st and 2nd day had side effect of chills for a couple hours each day and low grade fever the 2nd day. No side effects the 3rd day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Dietary Supplements...No prescription medications or other over the counter medications,None,None,,Sulfa,"['Chills', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 932979,IN,35.0,M,"BODY ACHE, FEVER, PAIN IN ARM",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PUB,omeprazole 40 MG sumatriptan 100 MG Pregabalin 150 MG,Migraines,Migraines,,None,"['Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 932980,AZ,77.0,F,Unknown,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/10/2021,01/10/2021,0.0,PVT,Hydrocortisone 25mg daily. Fludrocortisone 0.1mg daily. Cymbalta 30mg Daily. Gabapentin 900 mg BID. Vit. D 5000U daily. Vitamin c 2000mg daily.,None,Adrenal insufficiency Obesity,,No allergies,['Unevaluable event'],UNK,MODERNA,IM 932981,SD,49.0,F,"Severe tremor, stuttering speech, extreme fatigue, weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Propranolol 10mg Imitrex Vitamin B Probiotic,None,Iron overload,,Codeine Sulfa Dairy Eggs,"['Asthenia', 'Dysphemia', 'Fatigue', 'Metabolic function test', 'Tremor']",1,MODERNA,IM 932982,CO,41.0,F,"Nausea, body aches, fever (100.1 max), headache, extreme fatigue. Fever one day, body aches, extreme fatigue and headaches 2 days, normal fatigue and nausea about a week.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/20/2020,3.0,PVT,Locating Hctz. Effexor. Wellbutrin. Multivitamin. B complex. Vit d.,None,"HTN, Asthma, depression, anxiety, gastritis",,,"['Fatigue', 'Headache', 'Influenza virus test negative', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 932983,IL,36.0,F,"low grade fever, chills, body aches (neck and back), fatigue, headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,WRK,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932984,CA,46.0,F,A skin legion developed with a large fluid filled blister. Thanks,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,UNK,"Wellbutrin, Propanol",None,I tested HIV positive in 2011. It was a false positive. One doctor theorized that I picked up a virus when traveling in Spain in August of that year.,,No known allergies,"['Blister', 'Skin lesion']",UNK,MODERNA,IM 932985,TX,51.0,F,Cellulitis at injection site requiring antibiotic. Did not respond to anti inflammatory,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/01/2021,01/09/2021,8.0,PVT,None,None,None,,Penicillin,['Injection site cellulitis'],1,MODERNA,IM 932986,WA,19.0,F,"I woke up this morning (approx 18 hrs post injection of my 2nd dose) feeling some myalgia, joint pain (perhaps 7/10 on a pain scale) and fatigue. I was able to work out (exercise bike 30 mins) and shower despite the pain. Then, around noon today (nearly 24 hrs post injection) I began feeling increasingly dizzy and warm. I stood to go to my bed and lost consciousness and collapsed. I was only unconscious for perhaps 15 seconds. I woke up feeling very shaky and cold and breathing rapidly. I was able to slow my respirations. My skin on my face and hands was very pale (lips were whitish blue). My housemate had called 911 for me: FD showed up and took a couple sets of orthostatic vitals. My BP when seated on the floor was around 110/80, pulse 80, and my BP when standing was around 90/70, pulse 100. I was able to walk to the bed without help so I decided to stay home and just hydrate, sleep, and keep a close eye on things. Now (1620, around 4 hrs after passing out). I still feel lots of soreness, but only very minor dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,50 mg sertraline daily,None,None,,"Penicillin, amoxicillin","['Arthralgia', 'Cyanosis', 'Dizziness', 'Fall', 'Fatigue', 'Feeling cold', 'Feeling hot', 'Loss of consciousness', 'Myalgia', 'Pain', 'Pallor', 'Respiratory rate increased', 'Tremor']",2,PFIZER\BIONTECH,IM 932987,,63.0,F,"Mild fever only the night of vaccination date Extreme muscular soreness, shoulder to elbow for 3 days, beginning the night of injection Moderately severe headache beginning the day after vaccination; lasting for 3 days By day 4, all side effects had disappeared By choice, Aleve was taken only once, the night of vaccination date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,MIL,omeprazole cetirizine probiotic,none,none,,none,"['Headache', 'Myalgia', 'Pyrexia']",UNK,MODERNA,SYR 932988,AR,58.0,M,Injection site pain Tiredness Headache Muscle pain Chills Joint pain Fever Nausea Feeling unwell,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,OTH,Lisinopril 10mg Isosorbide mononitrate er tab 60mg Ranolazine we ran 1000mg Metoprolol succinate er tab 75mg Atorvastatin calcium tab 80mg Centrum for men Osteo bi-flex Low dose aspirin 81mg Allegra allergy,None,I have had four heart attacks since 1998,,None,"['Arthralgia', 'Chills', 'Headache', 'Injection site pain', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,IM 932989,IN,49.0,F,"Felt achy and trouble sleeping all night post 2 nd injection. Woke up at 3 am with fever 100.5. Headache, chills, sweating, low grade fever 99.5 all day until about 10:00 pm on 1/8/21. 80% better on 1/9/21 just lower back soreness and mild headache. 100% better on 1/10/21. This was my second vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Multi-vitamin Centrum women, D3 50 mcg, fexofenadine 180 mg",None,None except seasonal allergies,,"Bactrim, azithromycin","['Back pain', 'Chills', 'Headache', 'Hyperhidrosis', 'Insomnia', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932990,WA,68.0,F,Headache after the inacoulation on Tuesday 12/29. Two days later I started hearing a ring in my right ear. The ring went away on Wednesday 1/6. However on Friday morning 1/8 I woke up with a headache and body aches more pronounced in my waist and abdomen. I took my temparture and it was 98.8 F. I started taking Tylenol 500 mg. every 6 to 8 hours. On Saturday 1/9 the chills came back around 8 pm. I continued taking 2 Tylenol every 6 or 8 hours until now Sunday 1/10 at 4:30 pm. I am still experiencing sore abdomen and joins.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/08/2021,10.0,PVT,1 Nabumetone 750 mg. 2 Krill Oil 500 mg 1 Probiotic 10 Billion Live Probiotic Cultures 1 Citracal 650 mg - Calsium Suplement +D3 (1000 IU) 1 Allendronate Sodium 70 Mg weekly (Sunday),None,None,,Azithromycin,"['Abdominal pain', 'Arthralgia', 'Chills', 'Headache', 'Pain', 'Tinnitus']",1,MODERNA,IM 932992,IN,42.0,F,"1-5 2:30am stomach pain, diarrhea. Injection site discomfort. As the day went on severe body aches, legs more so. 1-6 body aches, felt feverish without fever, 10:30am tongue began to spasm while in relaxed state. Top of tongue was raw from rubbing my top teeth. That continued through Thursday. Thursday morning I woke up feeling pretty good then approx 8:30 am spasm started in my right hand then right arm, both arms too full body convulsions. I was taken by ambulance and have since visited 5 hospitals with no answers. It?s now Sunday 1/10 and my body continues to have uncontrollable body movements.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,"Effexor 150mg, phentermine 37.5 mg, Methocarbamol 500 mg PRN Tylenol 500mg PRN",None,Mitral valve prolapse Depression Anxiety,"Flu 2004 extreme rash, swelling",Flu vaccine pertussis Wasp,"['Abdominal pain upper', 'Diarrhoea', 'Dyskinesia', 'Injection site discomfort', 'Muscle spasms', 'Pain', 'Pyrexia', 'Tongue spasm']",1,MODERNA,IM 932993,CO,41.0,F,"Nausea, headache, fatigue, muscle aches, fever (100.3) fever day one and 3. Headache muscle ache nausea and fatigue everyday so far.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Losartan Hctz, effexor, wellbutrin, pepcid ac, multivitamin, ibuprofen, Tylenol, b complex, vit d",None,"Asthma, HTN, depression, anxiety, gastritis","Nausea, headache, fatigue, fever",None,"['Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 932994,MI,28.0,F,"Friday (1/8/2021) day of vaccine Weird taste in my mouth and headache with a flushed feeling Saturday (1/9/2021) congestion and a slight runny nose, and watery eyes, and fatigue. Sunday (1/10/2021) very fatigued and around aprox 6pm after getting home from work and out of the shower i noticed the right side of my face was kind of numb. Kind of the same feeling you would experience when you go to the dentist and they give you a shot to numb the are.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,WRK,,M/A,"Obesity, acid reflux,",TB shot gives me a false reading every time. But chest xray is always clear.,TB shot,"['Fatigue', 'Flushing', 'Headache', 'Hypoaesthesia', 'Lacrimation increased', 'Respiratory tract congestion', 'Rhinorrhoea', 'Taste disorder']",1,MODERNA,SYR 932996,FL,74.0,F,Redness and swelling of injection site with extreme itching and hardness which appeared one week after the injection,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/10/2021,7.0,PUB,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 932997,OR,45.0,F,slight headache fatigue sore arm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,levothyroxine 75 mcg,None,hypothyroid,,"benzoly peroxide, sulfa, keflex, actifed","['Fatigue', 'Headache', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 932998,KY,46.0,F,Started menstrual cycle 36 hours after vaccine. Had not had it for two years.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,PVT,"Zoloft, Xanax, Gabapentin, protonix",None,Diabetes,,None,['Menstruation irregular'],1,MODERNA,IM 932999,TN,29.0,F,Twelve hours afterwards I had full-body convulsive-like shivers and ran a high temperature roughly 36 hours. The morning after I also had nausea and a few episodes of vomiting. 48 hours post-dose I had diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Synthroid, prenatal vitamins, folic acid",,Hypothyroidism,,None,"['Body temperature increased', 'Chills', 'Diarrhoea', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,SYR 933000,IN,52.0,F,"Woke up next day, severe stiffness, headache, fever, chills, fatigued. The injection site was red and extremely painful",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Concerta Zoloft Trazodone,None,obesity,,None,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Musculoskeletal stiffness', 'Pyrexia']",1,MODERNA,IM 933001,CO,58.0,F,"Arm Pain, Metallic taste, overnight chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Vit D3,none,none,,NKDA,"['Chills', 'Dysgeusia', 'Pain in extremity']",1,MODERNA,IM 933002,FL,58.0,F,"Lip swelling, face lesions, body aches. No history of botox or dermal fillers",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/07/2021,5.0,PVT,none,none,HTN,,none,"['Lip swelling', 'Pain', 'Skin lesion']",1,MODERNA,SYR 933003,WA,35.0,F,"Chest pain, 3/10- onset 25 minutes after vaccine given. Elevated BP 140's/90's and elevated HR to 126 noted on initial eval CP persisted throughout eval GI cocktail given and pt took own clonidine 0.1 mg once BP and HR normalized about 2.5 hours after onset",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,"Lorazepam prn, Potassium citrate, Albuterol HFA prn, Pantoprazole, Ajovy, Indomethacin, Trazodone at hs prn, Metoprolol XL, Clonidine prn, Venlafaxine, Microgestin",No known acute illness,"Lumbar HNP, Ovarian cyst, PUD, Panic disorder, GAD, PTSD, Reactive depression, Mild intermittent asthma, Renal stones, GERD, Endometeriosis, Migraine",,"Buspirone, Dicyclomine, Dilaudid, Morphine, Sulfa, Sulfasalazine, Zoloft, DHE, Prochlorperazine, Reglan, Triptans, Methylprednisolone, Tizanidine, Bee venom and Tree nuts.","['Blood pressure increased', 'Blood thyroid stimulating hormone normal', 'C-reactive protein normal', 'Chest X-ray normal', 'Chest pain', 'Electrocardiogram normal', 'Fibrin D dimer', 'Heart rate increased', 'Sinus tachycardia', 'Troponin normal', 'White blood cell count increased']",1,MODERNA,IM 933004,NJ,22.0,F,"Fever, chills, body aches, headache, diarrhea, muscle pain at injection site, whole left arm was sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2020,01/09/2021,367.0,SCH,,,,,"Allergies to cats, dogs, dust mites, grass, insects, roaches, pollen","['Chills', 'Diarrhoea', 'Headache', 'Injection site pain', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 933005,WA,51.0,F,"Got a red spot with a lump under the skin. It is hot to the touch. Drew a mark around the site. It started to expand from the marks, so went to urgent care 1/8/21. The doctor stated that I was having a local allergic reaction, also that they gave me the vaccination in the wrong spot on my arm. I was told to keep watch on the red hot bump, take Benadryl if not improved then go back in the the doctor. He took a picture to put in my chart to watch it. Did another line around the site to watch it 1/9/21 since it got bigger from when I went to the doctor. It kept getting bigger so went back to the doctor today 1/10/21. This doctor also stated that I was given the vaccination in the wrong spot on my arm. Now I'm on an antibiotic and a steroid. I'm to still watch it and if it doesn't improve I need to go back in. She also took another pic to put into my chart to see the size difference.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,UNK,none,NONE,NONE,,NKA,"['Local reaction', 'Mass', 'Product administered at inappropriate site', 'Skin warm']",1,MODERNA,SYR 933006,FL,46.0,F,"fever 100.5 (for 1 day), body aches (for 3 days), muscle pains (3 days) chills (1 day) , headache (4 days), severe pain in left arm to (3 days), joint pain (3 days). fever resolved with advil and aleve.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"hydroxychoroquine, aleve, vitamin c, super b-complex, biotin, zinc, centrum silver, calcium, xanax",covid-induced lupus,covid-induced lupus,,"morphine, dilaudid, percocet, bacitracin, iv iron","['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 933007,NY,34.0,F,Shot given in left deltoid at 520pm. L. Inner forearm hives noted 540pm. Continued to monitor. Feeling of needing to cough noted at 600pm. Lung sounds clear. Resolved Increased redness + itchiness on L. Arm. Patient took her own 25mg benydral at 605. Called on call Dr. who instructed to notify EMS. Continued to monitor patient. VS. pt refused to go to ED. Symptoms improved by 1930. PT able to go home per Dr.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,OTH,Zyrtec Eye cream (name unknown) Junel,None,None,"Meningitis, 18 years old, June",Sulfa Quinolones Macrolides Seasonal Penicillin Mold Reaction to meningitis vaccine Cat Dog Dust Environmental,"['Erythema', 'Pruritus', 'Urticaria']",1,MODERNA,IM 933008,AL,61.0,F,"Headache, nausea, body aches, joint pain, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,Advil,None,None,,None,"['Arthralgia', 'Fatigue', 'Headache', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,SYR 933010,IL,47.0,F,Threw up later that night.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,"Multivitamin, Introvale, Miralax powder, Senna tablet 8.6 mg 2 tabs BID, Vit C 500mg tab: 1 tab PO daily, Vit D 1000 Unit",None,Moderate intellectual / developmental disabilities. Chronic constipation. Dry eye syndrome.,,"NKDA, allergies to Cats, seasonal",['Vomiting'],1,MODERNA,IM 933011,OR,29.0,F,"Insidious onset of left axillary pain on post-vaccine day 5, increasing in severity the following day. Worsened by arm movement, limiting function. No LAD. On post-vaccine day 7, a bright streak of erythema and severe overlying warmth developed at injection site. Erythema resolved the following day, warmth is still present. Also, typical injection site pain occurred day of vaccine and resolved over following two days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/07/2021,5.0,PVT,Yaz,N/a,PCOS,,Amoxicillin-rash in childhood,"['Axillary pain', 'Injection site erythema', 'Injection site warmth', 'Pain']",UNK,MODERNA, 933012,NC,47.0,M,"Body aches, chills, temperature of 99.2F, diarrhea, injection site swelling, redness and pain. Symptoms resolved within 48hrs of vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,None,None,None,,None,"['Body temperature increased', 'Chills', 'Diarrhoea', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Pain']",2,PFIZER\BIONTECH,IM 933013,PA,50.0,F,After first shot notice a lump under my left armpit area. It didn?t quite go away and the after the second dose the lump got bigger and it?s a little tender this time. It?s been two days since the 2nd injection and doesn?t seem to be going down in size.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/19/2020,1.0,PVT,Tylenol,No,No,,No,"['Lymphadenopathy', 'Tenderness']",2,PFIZER\BIONTECH,SYR 933014,IA,52.0,F,"Extreme fatigue on Friday during the day, by 5pm I was running a low grade fever through the night that was 100.9 . Body aches, cold, headache, dizziness. Saturday ran fever off and on that never got above 100.9. Which broke Sunday am. Sunday just fatigue, sore arm that is warm to the touch, but not red.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Soliqua, metoprolol, jardiance, allopurinal, Xanax, zolpidem, mirtazepene, align, omeprazole, vitamin d, benazepril, pravastatin,",None,"Diabetes type 2, high blood pressure , high cholesterol, gout, insomnia, irregular heart beat, gerd .",,"Sulfa, penicillin , aspirin, erythromycin, keflex,","['Dizziness', 'Fatigue', 'Feeling hot', 'Headache', 'Nasopharyngitis', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 933016,CA,30.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Headache without fever, 3 days, treated with acetaminophen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,None,None,None,,None,['Headache'],1,PFIZER\BIONTECH, 933017,IN,64.0,F,About 24 hours after I got my injection I began to feel cold. I am by nature always cold but within 30 minutes I began to shiver. This intensified and I got to the point I was shaking hard and so cold. I had also had a headache all day but that is not unusual for me as I frequently have sinus headaches that can last all day. I took my temperature which was 98.3 but I took Tylenol anyway realizing I was likely having a vaccine reaction. I got into bed under my electric blanket. Ninety minutes later I had finally warmed up. In fact my feet and hands felt like they were on fire. I rechecked my temperature and it was up to 100.9. I peeled off my numerous clothing layers and I actually felt better since the chilling had stopped. I ate some dinner and watched TV and went to be around 11pm. I slept fitfully which is normal for me. As the night wore on I began chilling again. I got up sometime around 5am and took more Tylenol. If I remember my temperature was around 100.1. I slept several hours and woke up feeling ?back to normal?.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Daily otc multivitamin, calcium and vitamin otc tablet one po bid, otc stool softener one po bid, otc generic Zyrtec 10 mg one daily, Bonita 150 mg po q28 days, gabapentin 100 mg po q hs, and generic synthroid 75 mcg one po daily",None,Hypothyroidism and seasonal allergies,,Phenobarbital,"['Body temperature increased', 'Chills', 'Feeling cold', 'Feeling hot', 'Headache', 'Tremor']",2,PFIZER\BIONTECH,IM 933018,CO,43.0,F,fatigue and body aches developed about 12 hours after 1st injection which resolved after two days. About 3-4 days after injection had stuffy nose with extreme dryness and sores throughout both nasal passage resulting in epistaxis. It has been over 1 week without resolution of sores despite keep nasal passages moist and running humidifer.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/03/2021,3.0,WRK,"Divigel, Vitamin D",none,Crohn's (in remission); endometriosis (in remission s/p surgically induced menopause),,none,"['Epistaxis', 'Fatigue', 'Nasal congestion', 'Nasal discomfort', 'Nasal dryness', 'Pain']",1,PFIZER\BIONTECH,IM 933019,SC,75.0,F,"Extreme weakness, headache, all-over ache, fever then chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,SEN,"Lantus, atorvastatin, meloxicam, nexium, monokeulast sodium, Tylenol, benedryl, align, aspirin, melatonin, multivitamin. Voltaren Gel",None,"Diabetes, Type 2, high cholesterol, arthritis",,"Sulfa drugs, metformin","['Asthenia', 'Chills', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,SYR 933020,MA,25.0,F,"Moderna COVID-19 Vaccine EUA. Patient's aunt called me and told me that niece (patient) is 25yo having issues with coordination about a week after 1st Moderna vaccination shot. Unsure of exact vaccination date and onset of symptoms. really having to focus to place hands under water to wash them, walking through doors without bumping into them, turning on faucet, getting dressed; left hand is worse than right and not able to easily align things properly; ""feels like her brain isn't doing what she's telling it to do"". Aunt said the symptoms are not improving. Patient had tested negative for Covid the day she got the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Coordination abnormal', 'Diarrhoea', 'Headache', 'Loss of personal independence in daily activities', 'Mental impairment', 'Mobility decreased', 'Nausea', 'SARS-CoV-2 test negative', 'Vision blurred']",UNK,MODERNA, 933021,OR,61.0,F,Thursday and Friday night i had heart palpitations. Thursday night I had body aches all over and night sweats. Also night sweats Friday and Saturday night. Friday I broke out in a rash on the insides of both thighs and under my arm pits.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/07/2021,4.0,PVT,no,no,no,,no,"['Night sweats', 'Pain', 'Palpitations', 'Rash']",1,MODERNA,IM 933022,FL,45.0,M,"After first dose: arm pain a few hours after and chills 24 hours later that lasted 24hrs. Some joint pains persisted. After second dose: arm pain a few hours after. Twelve hours later I had chills, low grade fever 100.5, body aches, arthralgias, fatigue. These symptoms lasted for 24 hours continuously. 48 hrs later I still had fatigue and early morning chills. The body aches have continued to present time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,OTH,None,None,None,,None,"['Arthralgia', 'Chills', 'Fatigue', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 933023,OH,57.0,M,"Headache most frontal more pronounced overnight frontal sinus- 4-5 hours after second dose of vaccine Fever, myalgia and chill 12 hours post vaccination - took Tylenol and Motrin around the clock Intermittent wheezing. It's January 10 pm and I am still having above mentioned symptoms but intensity is significantly less.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,Multivitamins Crestor,No,Hyperlipidemia Operated for renal cell carcinoma 5 years ago,With flu vaccine usually developed low grade fever for a day,Sulpha Flagyl,"['Chills', 'Headache', 'Myalgia', 'Pyrexia', 'Wheezing']",2,PFIZER\BIONTECH,IM 933024,UT,61.0,M,"Severe Headache, neck, body and joint aches, chills/fever, no energy",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,Losartan 100 mg ; Atorvastatin 20 mg,None,None,,None,"['Arthralgia', 'Asthenia', 'Chills', 'Headache', 'Neck pain', 'Pain', 'Pyrexia']",1,MODERNA,SYR 933025,AZ,43.0,F,"Sudden, severe worst headache of her life, coupled with onset of oral herpetic lesions and inflammation to unrelated body part (belly button piercing) occurred one week after vaccination received. She presented to ED 12/28 noted to have hypokalemia and head CT showed mild occipital encephalitis, admitted overnight for obs subsequent brain MRI was normal. She was seen in my clinic 2 days later (1/4/21) and was started on 3 day course of Decadron, topical acyclovir for herpetic lesion. As she is a nurse, I kept her off work until resolution of symptoms. Seen again on 1/8/21, headache resolved. She did discuss CT and MRI results with neurologist. He was not convinced this was vaccine related. She is having 2nd dose of vaccine on 1/11/21.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/21/2020,12/28/2020,7.0,OTH,"methimazole 2.5 mg daily, MVI, D3, B12",none,hyperthyroidism,,None,"['Angiogram cerebral normal', 'Anion gap', 'Arteriogram carotid normal', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine normal', 'Blood glucose normal', 'Blood potassium decreased', 'Blood sodium normal', 'Carbon dioxide decreased', 'Computerised tomogram head abnormal', 'Encephalitis', 'Glomerular filtration rate normal', 'Glycosylated haemoglobin normal', 'Headache', 'Hypokalaemia', 'Inflammation', 'Ketonuria', 'Magnetic resonance imaging brain normal', 'Oral herpes', 'Platelet count normal', 'Posterior reversible encephalopathy syndrome', 'Urine ketone body present', 'White blood cell count normal']",1,MODERNA, 933026,NJ,48.0,F,"Received injection 1/8/2021 at 6:00 pm. 12 hours after injection experienced very sore arm, temp that peaked 101, aches and chills. Symptoms lasted about 15 hours. Upon waking on 1/10/2021 no fever, aches or chills. Sore arm continues.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,"Tamoxifen 20 mg daily, Mulitvitamin",None,None,,None,"['Body temperature increased', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 933027,NY,57.0,F,Sore arm for 3 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Loratadine, omegas, Bupropion, calcium, magnesium, vitamin B, C and D",,Celiac,,"Sulfa, adhesive",['Pain in extremity'],1,MODERNA,SYR 933028,WA,31.0,F,"One week after the shot (Left Arm), from my left deltoid to my left hand fingertips have a tingling sensation similar to a limb falling asleep. The frequency ranges from every two hours to every 5 minutes with the sensation lasting for about 5 seconds.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PVT,None,None,None,,None,['Paraesthesia'],UNK,PFIZER\BIONTECH,SYR 933029,IL,25.0,F,"About 12 hours after recieving the vaccine, lots of pain in upper arm muscle and very sore to touch. Extreme fatigue and body aches with onset about 12-24 hours after receiving vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,UNK,,,"asthma, PCOS",,,"['Fatigue', 'Myalgia', 'Pain', 'Pain in extremity', 'Tenderness']",2,PFIZER\BIONTECH,IM 933030,WA,24.0,F,Received first dose Dec 20 with no symptoms. Second dose received Jan 9 and ~12hours afterwards felt full body muscle aches and fatigue at which point I took Tylenol 500mg 4hrs apart twice with no relief. Went to sleep Jan 10 7AM until 4PM and woke up symptom free.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,"Wellbutrin 300mg daily, Tylenol 500mg taken twice (when feeling symptoms from vaccination)",,,,,"['Fatigue', 'Myalgia']",2,PFIZER\BIONTECH,IM 933031,IL,51.0,F,"Chills, fever, headache, joint pain, nausea, vomiting, weakness, sweating, fatigue, no appetite. Pain at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,OTH,"Spironolactone 25mg bid Bupropion 300mg daily Vit c 1000mg daily Vit d 5,000 units daily Magnesium 400mg daily",None,Hypertension,,NKDA,"['Arthralgia', 'Asthenia', 'Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,SYR 933032,VT,42.0,F,"On day 10 after injection,redness,warmth,swelling and low grade temp",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/08/2021,10.0,PVT,none,none,none,,NKA,"['Erythema', 'Skin warm', 'Swelling']",1,MODERNA,IM 933033,NY,60.0,F,"Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improved with Meloxicam. The keratitis flared up. Developed keratitis after the first dose on 12/17/2020. Lot EK5730. The keratitis presented with dry eyes, photophobia and reduced reading ability. I am treated with steroid drops and artificial tears.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,None,"Breast cancer in remission on maintenance Xeloda PO. One week on, three weeks off, 1500 mg in am, 1000 mg in pm. Vitamin B 6 100 mg BID, Meloxicam 15 mg q 24 hours","Breast Ca, chemotherapy induced neuropathy",,Wasps with anaphylaxis,"['Asthenia', 'Bone pain', 'Chills', 'Diarrhoea', 'Dry eye', 'Keratitis', 'Myalgia', 'Ophthalmological examination', 'Photophobia']",UNK,PFIZER\BIONTECH,IM 933036,TX,44.0,M,"Fever, chills, body aches, pain on site, bruise on site after 2nd day. slight dizziness , flushing and increased Heart rhythm on day log administration for about a minute and resolved. Have been having mild to moderate pain on right kidney area.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,OTH,Loratadine,Asthma,"Asthma, kidney stone episode, high cholesterol","Flu vaccine, slightly dizziness",Unknown source Fried chicken,"['Chills', 'Dizziness', 'Flushing', 'Heart rate increased', 'Injection site bruising', 'Injection site pain', 'Pain', 'Pyrexia', 'Renal pain']",1,MODERNA,IM 933037,TX,36.0,M,Hives,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/10/2021,4.0,MIL,Ibuprofen,None,None,,None,['Urticaria'],2,PFIZER\BIONTECH,SC 933039,MA,58.0,F,"Chest pressure and ""gulping"" need/sensation. Started immediately after vaccine was given, but patient did not tell staff until about 15-20 min after vaccination. Mild tachycardia with HR 80, BP 134/70, O2 sat 100%, RR 42. Symptoms persisted and 0.3 mg Epinephrine IM was administered, followed by 50 mg of diphenhydramine. about 30 min after the vaccine was administered. Patient 's chest discomfort improved within 5 minutes and her ""gulping "" sensation improved within 10 minutes. She was then instructed to go to the ER for further monitoring. She was stable throughout the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,"No medications reported. Pt did report taking dietary supplements, which supplements are unknown to this provider.",None reported,Pt denied any significant chronic medical conditions.,,allergy to contrast dye,"['Chest discomfort', 'Oropharyngeal discomfort', 'Tachycardia']",UNK,MODERNA,IM 933040,MA,63.0,F,"chills, fever, sweating and tired started at 5:00 pm the night after receiving the vaccine, in the morning felt much better",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,UNK,"Tylenol, cephalexin",skin infection on my fingers,none,,sulfur clindamycin microdantin,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Pyrexia']",2,PFIZER\BIONTECH, 933041,FL,29.0,M,"Injection site pain, body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Injection site pain', 'Pain']",2,PFIZER\BIONTECH,IM 933042,VT,53.0,M,"7 days after, developed swelling,redness,rash, and swollen lymph gland",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,PVT,none,no,none,,none,"['Erythema', 'Lymphadenopathy', 'Rash', 'Swelling']",1,MODERNA,IM 933043,OR,50.0,F,Diarrhea started after having mild chills at around 1300hrs on 1/8/2021; then followed by tiredness and weakness. Got home at around 1545hrs and I continued to have diarrhea all night until Saturday -all day. Diarrhea settled at around 1800hrs.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,SEN,Took my metformin 1000mg at 0730 hrs and micardis 40mg at 0730hrs,None,Hypertension and diabetic type 2,,"NSAIDs, seafoods","['Asthenia', 'Chills', 'Diarrhoea', 'Fatigue']",1,PFIZER\BIONTECH,IM 933044,NY,37.0,F,"After a week and a half, where the vaccination was administered I got a large red circled rash about the size of a grapefruit.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/08/2021,9.0,OTH,none,none,none,,none,"['Vaccination site rash', 'Vaccination site reaction']",1,MODERNA,SYR 933045,,25.0,F,"(Written next day) Patient stated that shortly after receiving the vaccine approximately 30-60 min minutes later she started to feel swelling in her face as well as her lips. She took a photo of this and showed it to me today and well. The swelling around the eyes seemed minimal. Her lips were swollen. She also notes that she felt tired and had a mild shortness of breath where she felt more comfortable sitting up. She states these symptoms have somewhat improved, though she has been experiencing increasing nausea since yesterday and continues to feel that way. She states that she does not believe she is pregnant, she has an IUD. She also noticed some body aches yesterday, continuing this morning, but they seem to be improving. They do improve greatly with ibuprofen at home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Sertraline 50 mg QD,None,None,,NKDA,"['Dyspnoea', 'Fatigue', 'Lip swelling', 'Nausea', 'Pain', 'Periorbital swelling', 'Swelling face']",1,MODERNA,IM 933046,TX,26.0,F,"shortness of breath, difficulty breathing",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,None,None,None,,None,['Dyspnoea'],1,MODERNA,IM 933047,IA,64.0,F,"L upper arm started itching badly 1/5/21 later in the afternoon. I finally looked at it in the evening. The skin was red around the injection site, at least 3x5"". At the margin there were a number of small hives and the entire area was hot and indurated. It was not painful, just itchy. The next day the hives were gone but the area was larger, and still red, hot and indurated. It continued that way and grew in size that day and the next. Itching improved and by Friday 1/8 the redness was gone (almost completely encircled my arm at one point). I still have occasional itching. One of the physicians I work with said it was a delayed hypersensitivity reaction and that I should get the 2nd shot in the R arm and pre-medicate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,PVT,"Losartan, amlodipine, fenofibrate, atorvastatin, meloxicam, escitalopram, multivitamin, calcium plus D3, vitamin D3",None,"Hypertension--well-controlled, high cholesterol and triglycerides--well-controlled",,Sulfa antibiotic,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site urticaria', 'Injection site warmth', 'Skin reaction', 'Type IV hypersensitivity reaction']",1,MODERNA,IM 933048,NJ,33.0,F,"Myalgia, Fever, Diaphoresis. Onset was approx. 12 hours after 2nd dose of the Pfizer-BioNTech COVID 19 vaccine. Symptoms lasted approx. 16 hours. Symptoms were relieved with otc Tylenol and Ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,None,None,None,,None,"['Hyperhidrosis', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933049,VT,59.0,F,"On 1/6/21 developedwarmth,redness,and tenderness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/06/2021,9.0,PVT,"simvastatin,metformin",none,"DM,Hyperlipidemia",,none,"['Erythema', 'Skin warm', 'Tenderness']",1,MODERNA,IM 933050,FL,31.0,M,"Body aches, fever, injection site pain and redness, bilateral upper arm erythema, sore throat lasting 8 hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Erythema', 'Injection site erythema', 'Injection site pain', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933051,AL,25.0,F,"Symptoms-Chills, soreness in injection site arm, and body aches Chills and body aches lasted for approximately 24 hours. Soreness in injection site arm started within an hour of receiving the vaccine and continued for more than 48 hours. Symptoms were managed with Tylenol and warm compress. With Tylenol and warm compress symptom severity decreased but was still present.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,None,None,None,,Penicillin,"['Chills', 'Injection site pain', 'Pain']",2,PFIZER\BIONTECH,SYR 933052,KS,40.0,F,"Atypical Reactions: Swollen lymph node above my left collar bone began three days after injection and continues to be swollen and tender currently (11 days post injection), tingling in hands and feet, depression and severe fatigue continues as well. Typical Reactions: Sore arm for one day, swelling for 3 days, redness for 6 days, hard knot at injection site for > 7 days, headaches and nausea > 10 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,UNK,"Zoloft 125 mg, Vit D.",None,None,,None,"['Depression', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Lymph node pain', 'Lymphadenopathy', 'Nausea', 'Paraesthesia']",1,MODERNA,IM 933053,MO,29.0,F,Softball red size mark. Mostly raised and hot to touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,UNK,Birth Control,,,,Ceclor,"['Erythema', 'Skin warm', 'Swelling']",1,MODERNA,SYR 933054,,20.0,F,"Chills within 8 hours of shot; fever, nausea, vomiting, chills, body aches started 12 hours after shot lasting for 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Birth control,,,,,"['Chills', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 933055,,24.0,F,"Chills, headache, myalgia 6 hours after vaccine administration. Symptoms stopped about 42 hours after administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Chills', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH,IM 933056,MT,35.0,F,After the second dose I had headache and body aches. More concerning was a build up of fluid around my left armpit and left chest.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,WRK,Daily vitamin,None,,,Neoprene,"['Fluid retention', 'Headache', 'Pain']",2,PFIZER\BIONTECH,SYR 933057,CA,39.0,F,"Severe Headache, body aches, chills, fatigue, and metallic taste in mouth",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/10/2021,1.0,PVT,Coumadin Metoprolol,None,Clotting disorder Hypertension,,Percocet Nsaids,"['Chills', 'Dysgeusia', 'Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH,SYR 933058,TX,42.0,F,I HAD SUDDEN MILD THROAT DISCOMFORT DIFICULTY SWOLLOWING THAT NEVER WENT ALWAY.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/26/2020,0.0,PVT,,,,,,"['Dysphagia', 'Oropharyngeal discomfort']",1,PFIZER\BIONTECH, 933059,MN,65.0,F,"History of Bell's Palsy. This type of pain by R neck off and on for the first week. Also Fatique 1/3 started. On 1/9/2021 started having jaw/ neck pain. To ED where CT scan showed inflammation around parotid gland. The doctors had never seen this before, I was told it was viral and to take ASA for pain, rest and fluids. Swelling decreased with ice pack although not totally resolved on 1/10/2020. Still fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/04/2021,5.0,PVT,"ambien, bupropion, effexor, flonase, zyrtec, trazodone, Vit C, Vit D, calcium, occuvite generic, Culturelle","sinus issues, chonic","C-IBS, BiPolar, depression, anxiety, osteopenia, osteoarthritis, hx Bells Palsy, fibrocystic breasts",,"dust mites, gluten, corn, topical neospin","['Computerised tomogram abnormal', 'Fatigue', 'Neck pain', 'Noninfective sialoadenitis', 'Pain in jaw', 'Swelling', 'Viral parotitis']",1,MODERNA,IM 933060,MD,42.0,F,"At 12:35 patient complained of feeling dizzy, light headed, nauseated and of having difficulty moving her arms or opening her eyes. She was diaphoretic at the onset of symptoms she was able to follow commands and answer questions but that became increasingly difficult. Symptoms worsen and patient started to vomit. Ambulance was called but patient refused to go with them. Felt better approximately 40 minutes after being vaccinated. Left accompanied by her husband.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,Muscle relaxants,None,Intermittent back pain,,None,"['Disturbance in attention', 'Dizziness', 'Eyelid function disorder', 'Hyperhidrosis', 'Mobility decreased', 'Nausea', 'Vomiting']",1,MODERNA,IM 933061,AK,40.0,F,"I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I started feeling tired and a couple hours after that I felt crummy and the chills started. Mine weren't nearly as bad as some others have experienced. I didn't sleep well that night and woke up with a mild headache and body aches. Approximately 10AM on Thursday I noticed I had swelling in my upper lip and later my jawline with slight numbness. My eyes started feeling puffy that evening, approximately 6:30pm, and the symptoms began to improve after taking a Benadryl around 7:15pm. The swelling and numbness didn't seem to move down towards my throat nor did I experience any difficulty breathing or swallowing. I sl",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,OTH,"Zyrtec, vitamin C, vitamin D, glucosamine, iron, fish oil, eld",None,None,,Dust & mold,"['Chills', 'Eye swelling', 'Fatigue', 'Feeling abnormal', 'Headache', 'Hypoaesthesia', 'Lip swelling', 'Pain', 'Sleep disorder', 'Swelling face']",2,PFIZER\BIONTECH,SYR 933062,VT,44.0,M,"Moderna COVID-19 Vaccine EUA. I had Covid-19 in March 16,2020. 24 hours post vaccination, I am experiencing exactly same symptoms as when I was sick with Covid-19. Symptoms started exactly 22 hours after I recevied the vaccine. Symptoms/ Side effects : Fever, highest so far 100.8, chills, malaise, headache, diarrhea , runny nose, nasal congestion, overall an unwell feeling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,WRK,Losartan 100 mg daily Alopurinol 200 mg daily,N?A,Gout Hypertension,,NKDA,"['Chills', 'Diarrhoea', 'Headache', 'Malaise', 'Nasal congestion', 'Pyrexia', 'Rhinorrhoea']",1,MODERNA,IM 933063,TX,25.0,F,"Starting January 4th, 2021, I noticed that I was itching on my chest and found a rash localized to my medial chest. The rash didn't appear to grow from the area. Later, on January 9th, I began to itch more on my lower back of neck and upper back and had someone take a look. They noted I had a rash in the upper back as well. Taking another claritin, tylenol, and using hydrocortisone cream has not helped with the rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/04/2021,6.0,WRK,Claritin over the counter,,,,"Fish, Peanuts","['Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 933064,NJ,45.0,F,"Face became red and flushed at 10:00 the next morning (1/8/21) and symptoms subsided by 12:45 pm. A second, milder flush of the face (pink) occurred at 5:15 pm and was resolved by 6:30 pm. Called health care provider, monitored symptoms, but no treatment needed or sought. No additional reoccurrences.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PHM,"Vitamins, probiotic",None,None,,None,"['Erythema', 'Flushing']",1,MODERNA,IM 933065,CO,28.0,F,"Fatigue, body aches, headache, low grade fever, arm pain, axillary pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Fiber supplement, choline supplement, ibuprofen",Headache,None,,"Penicillin, amoxicillin, sulfa drugs, clindamycin","['Axillary pain', 'Fatigue', 'Headache', 'Monoplegia', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933066,CA,39.0,F,"Fever 100.5, muscle aches, joint pain lasting 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,UNK,Cymbalta 90mg Lamictal 350mg Lisinipril 40mg Potassium chloride Claritin 10mg Gabapentin 600mg Flonase 2 sprays per nostril Bariatric Multivitamin with Iron Flaxseed oil Vitamin C Zicam with zinc,COVID 19 on 12/17/20,High blood pressure Depression Anxiety,,No,"['Arthralgia', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 933067,AK,54.0,F,"Arm swelling and soreness, Headache, Nausea, Muscle Aches, Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,UNK,"Vitamin D, Calcium/Magnesium supplement, Glucosamine and Chondroitin",None,None,,No,"['Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 933068,OR,33.0,F,"Within 12 hrs: full body aches, full body chills, very low energy. For 36 hrs after: extremely low energy (stayed in bed when normally I go running & am very active). Still totally manageable symptoms, & preferable to covid. But have not had reactions to any vaccines previously, was surprised. Also believe these are in common symptoms/signs for vaccine. Just adding data.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,None,None,None,,Allergic to bees/wasps,"['Asthenia', 'Chills', 'Pain']",1,MODERNA,IM 933069,NM,37.0,M,"Facial weakness (left side), lip paralysis (left side), decreased sense of taste, eye leakage (left side), facial tingling (left side). Onset 1/4/2021 with symptoms worsening through the week. Noticeable lip paralysis starting on the afternoon of 1/10/2021. 2nd vaccine received at 8:00AM on 1/10/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,01/04/2021,14.0,WRK,"Metformin, Lisinopril",None,"Diabetes, hypertension",,NKA,"['Facial paresis', 'Lacrimation increased', 'Paraesthesia', 'Paraesthesia oral', 'Taste disorder']",1,PFIZER\BIONTECH,IM 933070,MD,29.0,F,"Flushed red, tingling in left arm and left waist after the shot (10 minutes), arm soreness day after with fever (all day).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PUB,"Aspirin, atrovastatin, centrum women, melatonin, metformin, fomatadin",None,"Stroke, pre-diabetic",,None,"['Erythema', 'Flushing', 'Pain in extremity', 'Paraesthesia', 'Pyrexia']",1,MODERNA,SYR 933071,MN,65.0,F,"Started with fatigue on 1/3 approximately, Then 1/4 approximately pain in back of head, near R ear, symptoms similar to when previously dx Bell's Palsy. On 1/9 jaw pain, neck swelling and went to ED. CT scan showed inflammation surrounding the parotid gland, but not in the gland, no tooth abscess. The doctors have not seen this before and thought it was viral. No meds, only ASA, rest and fluids. Some swelling today 1/10/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PVT,"ambien, trazadone, bupropion, effexor, fosamax, calcium, Vit C, Vit D, generic ocuvite, calcium, probiotic","sinus symptoms, chronic","IBS-constipation, BiPolar with depression, anxiety, osteopenia, osteoarthritis, Hx Bell's Palsy, allergies, sinus infections",,"gluten, corn, topical neosporin","['Computerised tomogram abnormal', 'Fatigue', 'Headache', 'Noninfective sialoadenitis', 'Pain in jaw', 'Swelling']",1,MODERNA,IM 933072,WA,47.0,F,The vaccination was administered on my left shoulder at the rotator cuff or subacromial bursa area. I want to communicate that it was way too high in the shoulder and I experienced loss range of motion in Left shoulder for 5 days. I am feeling better today. Is the vaccination effective if given high in the shoulder? I have photos of bandaid and area of bruising if that is helpful. I want to make sure that those giving the vaccination know where to administer.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,None.,None.,None.,,Bad response to Pineapple and sulfa drugs.,"['Contusion', 'Joint range of motion decreased', 'Product administered at inappropriate site']",1,MODERNA, 933073,,63.0,F,"Large itchy welts left upper arm 12 days after initial shot , over next day became red painful, swollen entire left upper arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/09/2021,11.0,UNK,"Lipitor 20 mg once a day, vitamin D 50,000u once a week","being treated for breast cancer with daily radiation, finished chemo November 19","hyperlipidemia, non toxic goiter, breast cancer",,"sulfa, penicillin, vancomycin","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria']",1,MODERNA,IM 933074,IA,43.0,F,"Nausea, chills, fever (100), body aches, headache, and fatigue lasting for about 48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PUB,none,none,none,,Penecillin Erythromyacin Sulfa,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 933075,PA,69.0,M,Fatigue Aches Joint pain Chills,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/10/2021,2.0,PUB,Metformin Jardiance Avorstatin,None,Pre-diabetic,,Penicillin,"['Arthralgia', 'Chills', 'Fatigue', 'Pain']",UNK,MODERNA, 933076,PA,61.0,F,"Aches , pains , chills , fatigue , runny nose .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PUB,"adderal. 10mg hydroclorothyizide 10 mg Vitamin c ,",None,Seasonal asthma hypertension,,"Latex, clyndamycin , tamiflu . codeine ,","['Chills', 'Fatigue', 'Pain', 'Rhinorrhoea']",1,MODERNA,SYR 933077,MD,42.0,F,"Complained of feeling ""flushed,"" dizzy, sweating, chills, nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,None,Reports no illness,None,,None,"['Chills', 'Dizziness', 'Flushing', 'Hyperhidrosis', 'Nausea']",1,MODERNA,IM 933078,MN,34.0,F,"16 hr post injection: sore arm, headache 20 hr post injection: body aches, headache 26 hr post injection: body aches increase, chills, fever (Tmax 101.2 36 hr post injection: back to normal baseline state",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,OTH,None,None,None,,"Septra, amoxicillin","['Chills', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933079,MA,62.0,F,"Early morning Friday 01/08/21, moderate pain at injection site, PO Tylenol 1000mg, @ 0615, heading into work. Then @ 1030 feeling tired, neck & shoulder pain, chills, headache, right ear pain, slight sore throat, PO Motrin, 400mg moderate relief. Total of 30 hrs of recurring symptoms, alternating Tylenol & Motrin throughout. Started to feel better Saturday afternoon 4-4:30p",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,WRK,"Multi Vit, Vit C, Cal/Mag w/D, Fish Oil Acetominophen 1000mg 1 hr before vaccine",,"Hx of migraine s/p concussion, Arthritis (DJD)",,NKA,"['Arthralgia', 'Chills', 'Ear pain', 'Fatigue', 'Headache', 'Injection site pain', 'Neck pain', 'Oropharyngeal pain']",2,PFIZER\BIONTECH,IM 933080,IN,25.0,F,"Low fever, nausea, fatigue, headache, pain at injection site Nausea, fatigue, and fever went away next day, and headache and pain at injection sight went away after two days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,Nikki (birth control),Covid-19 (began 12/3/2020),N/a,,N/a,"['Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pyrexia']",1,MODERNA,SYR 933081,CA,50.0,F,"One sore and swollen lymph node between neck and shoulder, near clavicle",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,OTH,"Metformin ER 500mg twice a day, Vitamin D 2000 IU once a day, Vitamin B12 500mcg twice a week",None,"Pre-diabetes, panic attacks, occasional tachycardia, benign heart palpitations",,None,"['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 933082,WA,43.0,F,"Painful left arm starting 4 hours after injection, not yet resolved at 53 hours (improving). Low grade fever, chills, malaise, fatigue, joint and muscle pain, nausea, racing heart rate with mild exertion, all starting about 10 hours post vaccination, waxing and waning at 53 hours, slowly improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"Vitamin D, Iron Bisgylicinate, Iron Extra . Tylenol. Not taken same day of vaccination.",none,none.,,"Latex, pineapple, mango (anaphylaxis). Intolerance to codeine, aspirin, kiwi.","['Arthralgia', 'Chills', 'Fatigue', 'Malaise', 'Myalgia', 'Nausea', 'Pain in extremity', 'Palpitations', 'Pyrexia']",1,MODERNA,IM 933084,AL,35.0,F,"Swelling, redness, moderate itching at injection site Mild numbness, burning, raw feeling with mild feeling of swelling of tongue and lips, coughing, tightness in chest, flushed cheeks, Red rash under left arm pit, temp of 100.4. Body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,OTH,"Lamictal , Prozac, Tylenol, melatonin, folic acid, B12, Vit D",,Chronic hemiplegic migraines,,Aimevig Gabipentin,"['Body temperature increased', 'Chest discomfort', 'Cough', 'Flushing', 'Injection site erythema', 'Injection site hypoaesthesia', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Lip swelling', 'Pain', 'Rash erythematous', 'Swollen tongue']",2,PFIZER\BIONTECH,IM 933085,CT,35.0,F,"Severe body aches, joint pain, chills, fever Mild nausea vomiting and abdominal pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Fluoxetine, symbicort, singular",None,Asthma,,None,"['Abdominal pain', 'Arthralgia', 'Chills', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 933087,CA,36.0,F,"Within 24 hours of shot, experienced right facial numbness and decrease in facial tone. These symptoms disappeared within 24 hours. 2 days after shot, right side facial twitching occurred and then 3rd day the twitching went away. 01/08, noticed mild weakness in grip strength of right hand and tingling in right big toe. 01/10/2021, difficulty holding a pencil and numbness in pinky finger and right ring finger, also partial numbness in toes, of right foot as well slight reduction in right leg strength",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,,,,,,"['Facial paresis', 'Grip strength decreased', 'Hypoaesthesia', 'Muscle twitching', 'Muscular weakness', 'Paraesthesia']",1,MODERNA,IM 933088,NJ,50.0,M,8 hrs after shot felt extremely tired Sleeping that night had chills woke up in cold sweat Was combination of dreaming and hallucinating Next day entire body was soar. Notable pain in kidneys. Still every tired and head pressure,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,MultiVitamin (MEN 50+) Brain Health Formula TestBoost,No,None,,No,"['Chills', 'Cold sweat', 'Fatigue', 'Head discomfort', 'Pain', 'Renal pain']",1,MODERNA,SYR 933089,NY,33.0,F,Hives and itching from head to toe,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,PVT,"Vitamin b complex, iron supplement, biotin supplement, Xanax",None,None,,None,"['Pruritus', 'Urticaria']",1,MODERNA,IM 933090,CA,60.0,M,"Patient died, I have a copy of his vaccination card",Yes,01/09/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,Unknown,Unknown,Unknown,,Unknown,['Death'],2,PFIZER\BIONTECH,SYR 933091,CO,38.0,M,"Fever (101.5), chills, aches, light headed, nausea, dizzy, elevated heart rate (over 20bpm higher than normal resting average.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,OTH,"300mg Buproprion, daily multivitamin, vitamin D supplement, generic Allegra.",None,Childhood asthma,,Penicillin,"['Chills', 'Dizziness', 'Heart rate increased', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,SYR 933093,,39.0,F,"Symptoms of diarrhea, loss appetite started 36 hours after vaccine lasted for 3 days. Reports stomach ache and loss pf appetite today",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/28/2020,5.0,PVT,,,,,,"['Abdominal pain upper', 'Decreased appetite', 'Diarrhoea']",1,PFIZER\BIONTECH,IM 933094,TX,33.0,F,Large red circle appeared on week after vaccine at injection site on right arm. Lasted about 4 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/07/2021,9.0,PVT,Melatonin 3mg at night,None,None,,Red dye 40,['Injection site erythema'],1,MODERNA,SYR 933095,MD,48.0,F,"Patient 5 minutes after receiving her vaccine, started to complain of dizziness and feeling warm, having shudders, and also chest pressure on the left side. Heart rate 74. Rested, but symptoms, especially chest pressure, did not improve. Alert and oriented and able to answer questions. EMS called but patient refused transportation to hospital. Once she felt better was able to walk to her brother's car, she stated that her brother ( who picked up patient) would take her to closest hospital, to get checked out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PUB,"Medformin, Levothyroxine.",,Polycystic Ovary Syndrome,,None,"['Chest discomfort', 'Dizziness', 'Feeling hot', 'Tremor']",1,MODERNA,IM 933096,CA,30.0,F,"About 12 hours of receiving my second dose I started to get really bad chills. Nothing could keep me warm and I had a fever of 102. I had muscle aches as if I just went through a rigorous workout. I had zero appetite but I?m not sure if that was due to side effects or the fact that I wasn?t feeling well. When I did finally eat something that evening I could barely taste it, I ate it but my taste buds were faintly picking up the flavors. Again I don?t know if it was because of the side effects or the fact that I wasn?t feeling well. The following day, Saturday 01/09/21 I only had chills which would come and go. I did not have fever and my appetite was back. Now today, 01/10/21 I feel my usual self.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,Iron,None,None,,None,"['Ageusia', 'Chills', 'Decreased appetite', 'Malaise', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 933097,VA,37.0,F,"Sore arm, upset stomach and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,UNK,Levothyroxine 75mcg,No,No,,No,"['Abdominal discomfort', 'Fatigue', 'Pain in extremity']",2,PFIZER\BIONTECH,SYR 933098,GA,35.0,F,"Injection site swelling, redness and pain, started immediately post injection, fatigued that evening. Day following vaccine under arm(lymph node area) of injection arm swelling and pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,OTH,"Saxenda, LifePack multivitamins",None,None,,None,"['Fatigue', 'Immediate post-injection reaction', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 933099,MI,57.0,F,"Fever,chills. Body aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/28/2020,1.0,PVT,"Norvasc, Tenormin, Celexa, Lipitor, prebiotic",None,High blood pressure,,"Cipro, compazine, adverse reactions to narcotics and sedation","['Chills', 'Fatigue', 'Pain', 'Pyrexia']",1,MODERNA,SYR 933100,MD,36.0,F,Tingling in left thumb immediately after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,OTH,unknown,none,unknown,,unknown,"['Immediate post-injection reaction', 'Paraesthesia']",1,MODERNA,IM 933101,OH,29.0,M,"Moderna vaccine dose #1 received in right shoulder on 12/31/20 at 2:15PM. Injection was uneventful other than sensation of pressure. I did notice at the time, but could not fully see, that the injection appeared to be much higher on the shoulder than normal. I immediately came home afterwards and relaxed. Approximately 2hrs later, I began experiencing extreme pain in my right shoulder. As the night progressed, the pain worsened to 10/10 with inability to move my arm. Later that night after requiring assistance to take off my shirt, I noticed that the bandaid overlying the injection site was very high, immediately below and bordering the acromion process. This was concerning but I was hopeful the pain would go away over the next few days. I took tylenol that night. I woke up multiple times during the night because the pain was so severe. When I woke up, the pain and inability to move my arm were still present. I began taking 800mg ibuprofen and 1000mg tylenol alternating Q4 throughout the next few days. The pain and disability remained so severe that I required assistance performing ADLs for the next 4 days. On day four, with the pain not resolved and still severe despite consistent advil and tylenol use, I began having concern for shoulder injury related to vaccine administration. The next day I decided to seek an evaluation by an orthopedist. I am a physician and was unable to perform basic tasks and ADLs. I happened to have a few days off after the injection but would not have been able to work had I not. After an evaluation by the an orthopedic PA, I obtained an MRI of my right shoulder with results shown below - as I expected evidence of rotator cuff tendinopathy and subdeltoid bursitis consistent with SIRVA. As of now, I still have limited range of motion and shoulder pain on the right which has improved slightly but is far from resolved. I still have difficulty with certain ADLs including putting clothes on and off, lifting items, and tasks that require raising my right arm above my head. I am concerned with the possibility of long term and/or permanent damage after reviewing the literature. I am also concerned about how many other healthcare workers the person who gave me my vaccine may be injuring and/or causing permanent harm to.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/31/2020,12/31/2020,0.0,PVT,Wellbutrin,None,None,,None,"['Bursitis', 'Injected limb mobility decreased', 'Injection site discomfort', 'Injection site pain', 'Loss of personal independence in daily activities', 'Magnetic resonance imaging abnormal', 'Shoulder injury related to vaccine administration', 'Sleep disorder', 'Tendon disorder']",1,MODERNA,IM 933102,IN,50.0,F,"Low grade fever, large hard painful lump in right arm, achy joints",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,WRK,"Lisinopril, xyzal, hydroxychloroquine, hydrochlorthorizide",,"Mixed Connective Tissue Disease, High Blood Pressure",Whooping cough,None,"['Arthralgia', 'Induration', 'Pain in extremity', 'Pyrexia', 'Swelling']",2,PFIZER\BIONTECH,SYR 933103,IN,29.0,F,"After the second dose: arm pain at the site, chills, fatigue, body aches and headache for about 20 hours starting 4 hours after shot. After first dose: injection site pain the next day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,"Apri birth control, Zyertec",None,Migraines,,None,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pain']",2,PFIZER\BIONTECH,IM 933104,CA,76.0,F,"Extreme tiredness, headache, weakness in legs making walking uncoordinated, to the point of losing my balance on Sunday, January 3rd, could not do my regular jog my legs were so uncoordinated on Monday, January 4th, and I fell over on my side when I squatted to pick up my cat at the end of the jog, Difficult to climb my front steps. Tuesday , January 5th, similar leg weakness and lack of coordination, but milder. Less weakness on Wednesday, Jan 6th, when just walking. Thursday, January 7th, did a jog, almost normal, but my left ankle not as responsive as usual. Headache the whole time, and feeling like too much caffeine. I only have one black tea in am. Symptoms seemed most severe in AM. Headache eased up in evening of 1/7.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/03/2021,12.0,PVT,"Estring ring, 200mg Co enzymeQ10 qd, multivitamin, 2000 IU Vit D3 qd.NKA",none,none,,NKA,"['Asthenia', 'Balance disorder', 'Computerised tomogram head', 'Electrocardiogram normal', 'Fall', 'Fatigue', 'Feeling jittery', 'Gait disturbance', 'Headache', 'Metabolic function test', 'Muscular weakness', 'SARS-CoV-2 test negative', 'Troponin normal']",5,PFIZER\BIONTECH,IM 933105,ME,27.0,F,"Chills, headache, night sweats 2 days post shot and enlarged lymph node 4 days post vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Vitamin c,,,,,"['Chills', 'Headache', 'Lymphadenopathy', 'Night sweats']",2,PFIZER\BIONTECH,IM 933106,MD,21.0,F,"A few minutes after receiving the vaccine, patient complained of feeling dizzy, nauseated, having chills, and of her heart beating too fast. Patient alert and oriented. She called her mother to tell her how she was feeling. Heart rate increased from 100 to 150 five minutes later. EMS services called. Patient left via ambulance to hospital accompanied by a friend.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PUB,None,Denies any illnesses,None,,None,"['Chills', 'Dizziness', 'Heart rate increased', 'Nausea']",1,MODERNA,IM 933107,OR,35.0,F,"Fever up to 100.7, chills, myalgias, headache, and fatigue for about 36 hours total after 2nd dose of vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,None,None,None,,None known,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH, 933108,IN,51.0,M,"fever, muscles ache, extremely tired. Started on 1/7/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,PVT,Ibuprofen,diagnosed with pharyngitis on 12/27/2020,,,,"['Fatigue', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 933109,MA,32.0,F,"Tested for covid dec 22- negative, no symptoms Vaccine taken on dec 23 Extremely sick dec 31, tested positive for covid. Sore throat, muscle aches, cough, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/31/2020,8.0,PVT,None,None,None,,None,"['COVID-19', 'Cough', 'Fatigue', 'Malaise', 'Myalgia', 'Oropharyngeal pain', 'SARS-CoV-2 test negative', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,IM 933110,TX,35.0,F,"Nauseous, dizzy, sore arm, runny nose for an hour.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,MIL,None.,None,None,"Flu shot. Swollen face and eyes, runny nose, difficulty with breathing, hives.",Flu vaccines. Onions.,"['Dizziness', 'Nausea', 'Pain in extremity', 'Rhinorrhoea']",1,PFIZER\BIONTECH,IM 933111,CA,41.0,F,Cold sores broke out on lower lip 1 day after given injection. Abreva cream applied twice per day. The lesion was not changed.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,OTH,"Vitamin D, Zyrtec, Gabapentin",,"Back pain, seasonal allergy",,No known allergy,['Oral herpes'],2,PFIZER\BIONTECH,IM 933112,NJ,42.0,F,"Chills, Fever Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/09/2021,3.0,SEN,Unknown,,,,Unknown,"['Chills', 'Fatigue', 'Pyrexia']",1,PFIZER\BIONTECH,IM 933113,WA,43.0,M,Hives,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"Omeprozole, Metoprolol Succinate ER, Lisinopril.",None known.,"Acid reflux, high blood pressure.",,None known.,['Urticaria'],1,MODERNA,IM 933114,OR,42.0,F,"Pain and tingling in entire left arm, severe chills, bluish lips, weakness, fatigue, headache, muscle and joint pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Levothyroxine, phentermine, bupropion, losartan, topamax, vitamin d, multivitamin.",None,"Obesity, depression, hypothyroid, htn",,Nkda,"['Arthralgia', 'Asthenia', 'Chills', 'Fatigue', 'Headache', 'Lip discolouration', 'Myalgia', 'Pain in extremity', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 933115,IL,36.0,M,"body aches, headache, malaise, nausea and diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,Lexapro and Adderall.,none,"Depression, adhd",,none,"['Diarrhoea', 'Headache', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 933117,IL,49.0,F,"Temp of 101.4 highest, 100.8 later in the day, 100.0 the next day, body, muscle and joint aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,WRK,"Vit d cap, hrt estrogen/norestrogen, zyrtec",None,"Asthma, early menopause (age 32), arnold chiari 1, seasonal allergies",,"Sulpha, amoxicillin (anyphylactic), dust, mold","['Arthralgia', 'Body temperature increased', 'Myalgia', 'Pain', 'SARS-CoV-2 test']",1,MODERNA,IM 933118,CA,53.0,F,"Ten days after the vaccine injection my arm started hurting and swelled to the size of a baseball at the injection site. The lump was hot to the touch and had a large red circle about 3"" in diameter. I had tightness in my chest and a headache. I had took two Benadryls every eight hours for three days, since it seemed to be an allergic reaction to the vaccine. At this date/time I don't have any further signs of an allergic reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,01/04/2021,8.0,OTH,None,None,"Lupus, Rheumatoid Arthritis, Sjogren's Disease, Mixed Connective Tissue Disease, and Fibromyalgia",,"Allergic to medications that are in the caine family of drugs, Norco","['Chest discomfort', 'Headache', 'Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 933119,TX,51.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/23/2020,0.0,UNK,,,,Flu injection caused localized reaction on arm and flu like symptoms.,,['Unevaluable event'],UNK,MODERNA,IM 933120,,70.0,F,"Missed X1 day of work due to fatigue, felt better next day",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,PVT,,,,,,['Impaired work ability'],1,PFIZER\BIONTECH,IM 933121,IL,56.0,F,"Presented with headache, upset stomach, fatigue and discomfort.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,"Calcium / Vit D3 600-400, Lactulose Sol 6.5%, Magnesium tab 250mg, therems tab.",none,"severe intellectual disability, encephalopathy secondary to meningitis at age 18 mo. right eye blindness, vitiligo, chronic constipation, osteoporosis,",,NKDA,"['Abdominal discomfort', 'Discomfort', 'Fatigue', 'Headache']",1,MODERNA,IM 933122,OK,67.0,F,"3 days after vaccination, I had chills, fever above 102, and headache which lasted about 5 hours and subsided after taking Advil. I took Advil and the fever broken and the headache lessened. This repeated again the next day and again was better after taking Advil.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/08/2021,3.0,PUB,I had chills then fever of 102 and headache for 5 hours. I took Advil and the fever broken and the headache lessened. This repeated again the next day and again was better after taking Advil.,upset stomach on January 1st.,high blood pressure controlled by medication.,,penicillin,"['Chills', 'Headache', 'Pyrexia']",UNK,MODERNA, 933123,NC,60.0,F,"Side effects: Elevated blood pressure 208/96 & 204/94. Dizziness. Headache/heaviness in the head. Treatment: Went to emergency room on 1/3/2021. Increased blood pressure medication (DILTIAZEM) to 300mg and added another one (HYDRALAZINE) 25mg 3 times a day. Which my primary physician increased to 4 times a day,. Outcome: Lower blood pressure with occasional spikes to the borderline.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,PVT,Calcium Fish oil Multi vitamin,,High blood pressure (controlled),,,"['Blood pressure increased', 'Blood test normal', 'Condition aggravated', 'Dizziness', 'Electrocardiogram normal', 'Head discomfort', 'Headache', 'X-ray normal']",1,MODERNA,IM 933124,CA,34.0,M,THROAT EDEMA AND URTICARIA TO BUE 1-2 MINUTES AFTER VACCINATION,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,NONE,NONE,NONE,,UNKNOWN,"['Pharyngeal oedema', 'Urticaria']",1,MODERNA,IM 933125,,40.0,F,Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,PVT,,,,,,['Fatigue'],1,PFIZER\BIONTECH,IM 933126,,22.0,M,"01/4: Moderna Vax?developed headache shortly after injection 01/5: congestion, chills, weakness, body aches He?s taking over the counter meds for now.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Asthenia', 'Chills', 'Headache', 'Pain', 'Respiratory tract congestion']",1,MODERNA,IM 933127,IL,68.0,F,Presented with upset stomach/ loss of appetite.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,"Bethanecol tan 10mg, calcium/ Vit D3 tab 600-400, gemfibrozil tab 600mg, lactulose sol 10mg/ 15mL, levothyroxin tab 125mcg, nutrifur mac cap 50 mg, prednisolone sus 1% op, sertraline tab 100mg, symbicort aer 80-4.5, ventolin HFA AER,",none,"severe IDD, cerebral agenesis, hypothyroidism, microcephaly, major depression disorder, hypercholesterolemia, chronic constipation, hx of pneumonia, asthma",,NSAIDs; avoid nephrotoxic agents except for aspirin 81mg.,"['Abdominal discomfort', 'Decreased appetite']",1,MODERNA,IM 933128,TX,42.0,F,"Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions and my my body get hot from the inside out. I started sweating and my skin was turning red. I notified staff and they kept me an additional 30 minutes. I started getting hives and my body felt hot. The fire fighters asked the nursing staff for Benadryl they advised they did not carry it and could not give it to me. I carry Benadryl in my work bag due to my list of allergies. Fire assisting at location advised me to take Benadryl. I notified my employer because Benadryl makes me sleepy. They sent me home and I continued Benadryl and missed work for three days. At this time I went to prestige emergency about 1200 pm because the hives, heat in my body did not go away. I was treated and placed on an iv cocktail and sent home with several medications. Diagnosed with urticaria allergic by DR. symptoms did not improve my skin was still red I felt hot, confused, dizzy and returned back to the same ER 01/09/2021 I was also involved in an unrelated motor vehicle accident earlier in the morning so got treated for that and continued my explanation and treatment of how my body is not doing well with the Covid 19 shot. I presented with tachycardia and was instructed to continue my medications prescribed from 1st visit on 1/7/2021. Today is 1/10/2021. My body still feels hot, fatigue, confusion and light headed. Remained out from work and continued bed rest.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Vyvanse 50mg x1 Zolpidem 10mg (night),None,None,,"Shellfish Latex Ethylenediamine dihydrochloride Cobalt II chloride hexahydrate Iodopropynl butylcarbamate Fragrance mix Cocamindopropyl betaine Cinnamic aldehyde Glutaral Gold sodium thiosulfate Wool alcohols 2 broom 2 nitro propane-1,3-diol Bronopol Silver","['Confusional state', 'Dizziness', 'Dyspnoea', 'Erythema', 'Fatigue', 'Feeling hot', 'Hyperhidrosis', 'Impaired work ability', 'Palpitations', 'Tachycardia', 'Urticaria']",1,PFIZER\BIONTECH,IM 933129,TX,32.0,F,"Vaccine on 1/5- within the hour, developed severe headache and altered cognition/""brain fog."" Within a few hours, developed chills, body aches, nausea 1/6- 102 fever, severe headache, brain fog, chills, body aches, nausea, pain at injection site 1/7- 102 fever, severe headache, brain fog, chills, body aches, nausea, pain at injection site 1/8- 99 fever, severe headache, brain fog, body aches, nausea, pain at injection site and now very red/itchy/swollen 1/9- severe headache, body aches, nausea, injection site painful/red/itchy/swollen 1/10- severe headache, body aches, nausea, injection site painful/red/itchy/swollen and now bruised",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PHM,Wellbutrin XR,,Bechets syndrome rheumatoid arthritis history of childhood asthma,,"Penicillin, Vantin","['Chills', 'Feeling abnormal', 'Headache', 'Injection site bruising', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Mental status changes', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 933130,FL,34.0,M,"Experiencing moderate to severe ulnar nerve neuropathy or cubical tunnel syndrome (aka funny bone) since receiving first shot, worse after 2nd",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,"Pepcid 20 mg bid, omeprazole 20 mg daily",Nome,None,,No,"['Cubital tunnel syndrome', 'Neuropathy peripheral']",2,PFIZER\BIONTECH,IM 933131,FL,49.0,F,I received COVID 19 Pfizer vaccine on 12/23/20 and on 12/27/20 my blood pressure started to spike with readings 150's/100's while well controlled on medication- Metoprolol 25 mg tab daily. My BP remained elevated on 12/28 and i subsequently went to the ER and had chest XRay; EKG and cardiac workup done with all tests negative. I was instructed by ER Doctor to follow up with my cardiologist- Dr. and he subsequently changed my medication regimen to Metoprolol 25 mg tab twice daily. Since that episode my BP has been well controlled. I am not sure if there is a correlation with the vaccine. However i am bringing to your attention as i have never had a spike in BP while on BP meds.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/27/2020,4.0,PHM,Metoprolol 25 MG tablet once daily Vitamin D 2000 mcg daily Vitamin C 500 MG daily Progesterone 100 MG tab daily Estradiol 0.1 mg/day,none.,Chronic hypertension-well controlled.,,Tequin; Doxycycline; Pseudephedrine,"['Blood pressure increased', 'Chest X-ray normal', 'Electrocardiogram normal', 'Metabolic function test', 'Myocardial necrosis marker normal', 'White blood cell count']",1,PFIZER\BIONTECH,IM 933132,TX,41.0,F,"1/9 0230 bodyaches, chills, fatigue, fever, tightness in chest 1/10 2139-feels clammy and bodyaches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Chest discomfort', 'Chills', 'Cold sweat', 'Fatigue', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933133,,36.0,F,Sore throat,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/07/2021,2.0,PVT,,,,,,['Oropharyngeal pain'],1,PFIZER\BIONTECH,IM 933134,NJ,57.0,F,"Rigors, fever nausea, vomiting. diarrhea Severe muscle spasming/contraction, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,WRK,motrin,none,none,,none,"['Chills', 'Diarrhoea', 'Headache', 'Muscle contractions involuntary', 'Muscle spasms', 'Nausea', 'Pyrexia', 'Vomiting']",UNK,PFIZER\BIONTECH, 933135,IL,56.0,F,"Presented with fatigue, upset stomach, loss of appetite, crying out in discomfort, PRN tylenol admin.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,"Divalproex 250mg and 500mg ER, Lactulose sol 10mg/15mL, Levothyroxine 50mcg, Vit D 1000 units- 2 caps.",none,"intellectual disability, seizure disorder, obesity, hypothyroidism, hyponatremia, vit D deficiency, chronic constipation",,NKDA,"['Abdominal discomfort', 'Decreased appetite', 'Discomfort', 'Fatigue']",1,MODERNA,IM 933136,AZ,24.0,F,"Delayed reaction on injection site? one week after I got the first vaccine my arm at the injection sight swelled and had a red ring around it. A small rash formed underneath. Currently, it is still red, but much less swollen and not longer itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,"Generic birth control (lessina), xyzal (allergy pills), melatonin (10mg), hair skin and nails supplements (biotin)",None,None,,Grapefruit and Lobster,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling']",1,MODERNA,SYR 933137,CA,25.0,F,Had the chills and felt a little bit fatigue.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,UNK,,,,,,"['Chills', 'Fatigue']",1,PFIZER\BIONTECH,IM 933138,CT,26.0,F,"1 week following administration developed swelling to size of grapefruit, induration, redness with blanching, and itchiness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/10/2021,7.0,PVT,"Levothyroxine, skyla IUD",None,Hypothyroidism,,Wheat,"['Erythema', 'Induration', 'Pruritus', 'Swelling']",1,MODERNA,IM 933139,WA,63.0,F,"Hard, pounding tachycardia, with dizziness, nausea, headache, occurred about 5 minutes after vaccine was administered. The tachycardia resolved without medical intervention within 2 minutes. The remainder of the symptoms remained the rest of the day, along with profound fatigue and intermittent self limited tachycardia. The headache was managed with Tylenol. I slept most of the day and through the night. The following day, I had a headache, which was mild. Fatigue remained. I also noted intermittent tachycardia with mild exertion, self limited, less than 1 minute. Mild soreness at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,WRK,"Levothyroxine, omega 3, vitamin D3, glucosamine/chondroitin, magnesium oxide, multivitamin, loratadine",None,"Hypothyroidism, sub clinical, osteoarthritis,",,"Polymyxin, gluten, some dairy","['Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Tachycardia']",1,PFIZER\BIONTECH,IM 933140,VA,54.0,F,"Urticaria, treated with diphenhydramine, pepcid, prednisone. Improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/10/2021,4.0,PVT,,,,,,['Urticaria'],UNK,PFIZER\BIONTECH,IM 933141,,26.0,F,Muscle aches and chills X1 day,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Chills', 'Myalgia']",1,PFIZER\BIONTECH,IM 933142,AZ,48.0,F,"Pain at site of injection, eyes, throat, face swelling. Unclear thinking, hoarse speech, headache, hives, swelling. Intervention taken immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling, dizziness.",Not Reported,,Yes,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,UNK,,Sinus infection,"DM 1.5, tachycardia",,"PCN,Morphine, nuts, pumpkin, sour cream.","['Alopecia', 'Blood glucose increased', 'Chest X-ray', 'Cough', 'Dizziness', 'Dysphonia', 'Dyspnoea', 'Epistaxis', 'Eye swelling', 'Full blood count', 'Headache', 'Injection site pain', 'Mental impairment', 'Pharyngeal swelling', 'Swelling', 'Swelling face', 'Urticaria']",UNK,MODERNA, 933143,IL,39.0,F,"Threw up after eating lunch, severe agitation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,"Ca/ Vit D 600-400, clonazepam 0.5mg, Depakote 250mg, phillips laxative caplets 500mg, docusate, thera M Plus",none,"IDD, postural scoliosis, RETT's syndrome, agitation, anxiety disorder, autism, seizure disorder, chronic constipation.",,Famotidine,"['Agitation', 'Condition aggravated', 'Vomiting']",1,MODERNA,IM 933144,CA,30.0,F,"ABOUT 3 MINUTES AFTER RECEIVING VACCINE, PT REPORTED LIP SWELLING, PT EVALUATED AND FOUND TO HAVE MODERATE EDEMA TO LIPS, SENSATION OF SWELLING TONGUE AND THROAT. PT ALSO NOTED TO BE BRADYCARDIC, PLACED ON MONITOR, AND PT WAS IN BIGEMINY WITH A HR OF 55, PT GIVEN BENADRYL IM, VS WERE STABLE, MODERATELY HYPERTENSIVE, WITH AN 02 SAT OF 100%, IV ESTABLISHED AND PATIENT MONITOR WHILE AWAITING PARAMEDIC RECUSE AMBULANCE. PT DID NOT WORSEN AND BIGEMINY RESOLVED. 12 L PM WERE UNREMARKABLE, NO EPI GIVEN EN ROUTE, PT TRANSPORTED TO EMERGENCY DEPARTMENT WITHOUT INCIDENT.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,OTH,"FLOVENT, ALBUTEROL",NONE,ASTHMA,INFLUENZA VACCINE,AMOXICILLIN ? ANAPHYLACTOID REACTION TO INFLUENZA VACCINE,"['Bradycardia', 'Cardiac monitoring', 'Lip swelling', 'Pharyngeal swelling', 'Swollen tongue']",1,MODERNA,IM 933145,IN,81.0,M,"Serious weakness, inability to get up from sofa, very shivery, had to get assistance from facility nurse to get to bed. Temp was 102, talked to doctor by phone and took Tylenol. Slept for 4 hours. Was able to navigate again.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/10/2021,2.0,PUB,"xarelto, mestinon",none,"afib, myesthenia gravis",,none,"['Asthenia', 'Body temperature increased', 'Chills', 'Mobility decreased']",UNK,MODERNA, 933146,WY,36.0,F,"Hard swelling, heat, redness worsening daily for the last 12 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,"Zyrtec, Albuterol",None,Asthma,,Sulfa,"['Erythema', 'Induration', 'Skin warm', 'Swelling']",1,MODERNA,IM 933147,IL,52.0,M,"hypertension (pulse >100), dizziness. Pushed fluids.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,"levothyroxine 125mcg, loratadine 10mg, miralax.",none,"Moderate IDD, right keratoconus, dry eyes, seasonal allergies, chronic constipation, hypothyroidism, nasal congestion.",,"Haldol, seasonal allergies","['Dizziness', 'Hypertension']",1,MODERNA,IM 933148,OR,45.0,F,"1825 Patient reported feeling ""Shaky"", patient reports having same reaction with first vaccine and was observed in ED for 90 mins, had increased BP at that time that resolved by discharge. 1825 BP 156/101 HR 80 Patient declined ED, food, drink and had a rapid response nurse friend at chairside. assessment repeated at 1840 B/P 136/94 HR 80, 1850 BP 140/100 HR 75 pt. reporting feeling better. Pt. reported feeling much better and left with friend at 1900.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,,,,felt same reaction on first pfiser dose 12/20,,"['Blood pressure increased', 'Nervousness']",2,PFIZER\BIONTECH,IM 933149,TX,39.0,F,"Day 2 Friday: Headache, Chills, Vertigo, severe Nausea & Vomiting; Treatment: Esgic for Headache, Zofran for N&V Day 3 Saturday: Headache, Fever 101.1, Severe N&V; Same treatment Day 4 Sunday: Moderate N&V with mild headache, no fever, Treatment: Zofran",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Esgic,None,Raynauld's Disease Migraines UCTD Seronegative RA,,Sulfa,"['Chills', 'Headache', 'Nausea', 'Vertigo', 'Vomiting']",UNK,PFIZER\BIONTECH, 933150,IL,53.0,M,"Temp of 101.2, crying out in agitation / discomfort. treated with PRN Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,"zyloprim 100mg, celexa 10mg, claritin, miralax, prilosec otc tab 20mg, sucralfate 1gm, synthroid 88mcg, Vit D3 1000 units.",none,"severe IDD, gout unspecified, down syndrome, seasonal allergies, hypothyroidism, chronic constipation, impacted cerumen, chronic otitis media, depression, GERD.",,none,"['Body temperature increased', 'Crying', 'Discomfort']",1,MODERNA,IM 933151,,51.0,F,Received vaccine on 1/5/2021 and is complaining of swollen and stiff left arm and inability to move the left arm. States pain is 10 on a 10-point pain scale . Has been on Advil and Tylenol with no relief,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/07/2021,2.0,PVT,,,,,,"['Injection site swelling', 'Mobility decreased', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 933152,IL,38.0,M,Agitation and flushed face.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,"desmopressin 0.2mg, myrbetriq 25mg, vit D3 200 units.",none,"IDD, nocturnal enuresis, spastic diplegia, vit D deficiency",,oxybutynin,"['Agitation', 'Flushing']",1,MODERNA,IM 933153,AZ,37.0,F,Painful Acne like rash around the Lower half of my face. With redness and pus filled bumps Possible perioral dermatitis.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,OTH,"Ginger, turmeric, benzoyl peroxide wash 10%, retin A, vitamin D, Vitamin E topical, tea tree topical, collagen, vitamin C, vitamin B12","None. LMP December 25, 2020","Endometriosis, Acne",,RawCauliflower,"['Rash', 'Rash erythematous', 'Rash pustular']",1,MODERNA,IM 933154,MN,38.0,F,Shot given in L deltoid. Day 3-10 post vaccine I had extreme pain in what seemed like my left trapezius muscles. The pain was much worse in the evening/night and was sometimes absent during the day. Also on day 14 post vaccine (1/7/2021) I developed a cold sore for the first time in my life.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/26/2020,3.0,PVT,Flonase a few days/week,None but most days environmental allergies,None,,Nickle sensitivity,"['Myalgia', 'Oral herpes', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 933155,KY,31.0,M,Around 6 pm the following symptoms started: Heart rate was as high as 140 Body aches Felt like I had a fever Felt like pressure on chest Arm was very sore Had chills Nauseous,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,None,None,,None,"['Chest discomfort', 'Chills', 'Heart rate increased', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933156,CA,52.0,M,"General body aches, lost of appetite, general weakness, painful vaccination site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,Clindamycin 300gm,None,None,,Nkda,"['Asthenia', 'Decreased appetite', 'Pain', 'Vaccination site pain']",UNK,PFIZER\BIONTECH,IM 933157,,39.0,F,dizziness moderate x 45 minutes and currently mild,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,WRK,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 933158,MA,34.0,F,Employee became very itchy on left arm after vaccine administered. Left arm very red. Itchiness spread throughout her body.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,WRK,None,None,None,,Morphine - itching Percocet - itching,"['Erythema', 'Pain in extremity', 'Pruritus']",1,PFIZER\BIONTECH,IM 933159,CO,45.0,F,"No side effects with dose 1. After dose 2 at about 55 hours post injection, I woke up covered in hives head to toe. I took pictures if you need them.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/10/2021,3.0,PVT,75mg Levothyroxine 10mg Prozac,None,Hypothyroidism,,None that I know of,['Urticaria'],2,PFIZER\BIONTECH,SYR 933160,MO,61.0,F,"Moderna COVID-19 vaccine EUA 4-5 hours after vaccination, I started feeling sick: body aches, after that, during the night in addition to that I had a head ache. After that, i started feeling better. About 24 hours after the vaccination I started feeling worse again with body aches and headache. All my body was sick. During the night I had chills and a fever of 99.7. I felt sick and very tired all next day. More head ache and body aches. Was taking Tylenol every 5-6 hours, including the morning of day 5.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PHM,"low dose aspirin, simvastatin, metformin, multi vitamins","diabetes, high cholesterol",,,"penicilin, MRI contrast","['Chills', 'Fatigue', 'Headache', 'Malaise', 'Pain', 'Pyrexia']",1,MODERNA,SYR 933161,FL,71.0,M,"Fever, Nausea, Chills, Muscle Ache, Rash on back ,lasting 48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,"Amlodipine, Gabapentin, Hydralazine Calcitriol, Rosuvastatin, Baby Aspirin, Iron, Humalog",No,"Type 1 Diabetes, Stage 4 Kidney Failure",,None,"['Chills', 'Myalgia', 'Nausea', 'Pyrexia', 'Rash']",2,MODERNA,SYR 933162,NY,26.0,F,Body wide hives and throat tightening,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,"Prozac, birth control pill",Flu shot,N/a,,Eucalyptus,"['Throat tightness', 'Urticaria']",UNK,PFIZER\BIONTECH, 933163,NY,42.0,F,"Wed 930pm tingling nerve endings head to toe, migraine headache with aura, fever 100.3 Thu 530am SEVERE body aches, chills, migraine, sweats. 630am fever 101.3 body aches,HA/fever& chills all day. Max fever 102. Friday fatigued, all day until HA starts again at 2pm, along with 101 fever by 5pm...carries on with chills and Migraine aura thru evening until 1245am. Max fever 102 again.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Zero,Zero,"Prior Covid-19 + dx back on 3/22/20. 3/29/20: admitted to hosp with silent hypoxia, oxysats 84, in patient for 10 days, no vent.",,Seasonal allergies,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Migraine with aura', 'Pain', 'Paraesthesia', 'Pyrexia']",1,MODERNA,IM 933165,CA,74.0,F,Gastric pain Diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,Omeprazole Estradiol,None,None,,Sulfa drugs,"['Abdominal pain upper', 'Diarrhoea']",1,PFIZER\BIONTECH,IM 933166,,25.0,F,dizzy and heart racing; denies respiratory issues,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,WRK,,,,,,"['Dizziness', 'Palpitations']",1,PFIZER\BIONTECH,IM 933167,PA,,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,,,UNK,,,,,,['Unevaluable event'],UNK,MODERNA, 933168,MA,63.0,F,"At 13:10 the patient complained of sudden nausea while walking from injection room to seating area at vaccine clinic. States she did not eat lunch today, declined offer of snack or water. States she premedicated herself with 25 mg Benadryl 30 minutes before today's vaccine - as she does for all vaccines she gets.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,,,,,"Hx hives with cortizone injection. No vaccine reactions, drug, or food allergies.",['Nausea'],1,PFIZER\BIONTECH,IM 933169,,59.0,F,"Reaction site pain, fatigue, chills and joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/08/2021,2.0,WRK,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Injection site pain']",1,PFIZER\BIONTECH,IM 933170,MA,34.0,M,"0-14 hours: pain at injection site but no other notable symptoms. 14-18 hours: headache, muscle aches, joint aches, fatigue, increasing pain at injection site (without swelling or redness at injection site) 18-30 hours: headache, joint, and muscle aches, fatigue, with severe pain at injection site, fever of 99.6, chills, drenching sweating, puffy eyes, rash on torso and legs. 30-48 hours: all previous symptoms except puffy eyes and rash reduced with benadryl 48-60 hours: all previous symptoms. Fever increased to 100.4 F, Puffy eyes and rash returned more severe. Took benadryl and they reduced in severity. 60 hours: reduction in all symptoms. No more fever. Pain in arm reduced from severe to very mild (only noticeable if palpated). Only remaining symptom is fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,Multivitamin,,Asthma,,NKA,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Myalgia', 'Periorbital swelling', 'Pyrexia', 'Rash']",1,MODERNA,IM 933171,HI,46.0,F,"15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could feel my pulse escalating. Nurse in the post-shot monitoring tent took vitals to confirm pulse at 95, when typically 68. I was laid down and BP dropped to 110/78. Chest tightness that I am familiar with from asthma started to develop and my neck and throat and upper shoulders felt very tight and constricted. I had some trouble swallowing water as though my throat was constricted and my breathing felt shallow. Nurses provided care and I was asked to get up and sit in a chair again. Within a minute, I felt dizzy and disoriented again and heart rate went up. The tightness in my chest and throat and shallow breathing continued along with my voice becoming hoarse. The doctor on call asked if I?d had these symptoms before and I said I had after eating shrimp years ago. He decided to transfer me to the ER for monitoring . I stayed at the ER for about an hour and a half and was monitored. The constricted throat and asthma chest tightness did not subside but did not get worse. Doctor recommended Benadryl every 6 hours as symptoms persisted. Within a half hour of taking 25 mg of Benadryl, I started to feel improved breathing and less throat constriction and easier swallowing. After the second dose of Benadryl, symptoms were much 70% gone, except for hoarse voice abs very slight tightness with swallowing. I had informed the injection staff prior to receiving my vaccine that I am a person with a history of anaphylaxis (not to a vaccine) that required and epi pen and overnight hospital stay in the past .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2020,01/09/2020,0.0,PVT,Trazadone 50 mg for sleep Albuterol inhaler as needed for asthma,None,Asthma Insomnia,,Shrimp Bell peppers Ingredient in Barium for medical test,"['Blood pressure decreased', 'Chest discomfort', 'Disorientation', 'Dizziness', 'Dysphagia', 'Dysphonia', 'Feeling hot', 'Heart rate increased', 'Hypopnoea', 'Muscle tightness', 'Throat tightness']",1,PFIZER\BIONTECH,SYR 933172,MA,40.0,F,"headache and jaw/tooth pain on left side only evaluated by EMTs Vital signs stable , neuros intact, lungs CTA",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,,,None,,NKA,"['Headache', 'Pain in jaw', 'Toothache']",1,PFIZER\BIONTECH,IM 933173,,47.0,F,Location site pain X1 day and headache X2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/10/2021,2.0,WRK,,,,,,"['Headache', 'Injection site pain']",2,PFIZER\BIONTECH,IM 933174,MA,59.0,F,"shaking, fever, nausea, headache, and flu like symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,"Tylenol, Prilosec",,None,,NKA,"['Headache', 'Influenza like illness', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tremor']",1,MODERNA,IM 933175,KS,40.0,F,"Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Wellbutrin, Lamictal, Propranolol",None,"Anxiety/depression, tachycardia, migraines, eczema",,"latex, avocado, mango, penicillin, clindamycin, bactrim, tegaderm, adhesive tape, nickel","['Anaphylactic reaction', 'Chest pain', 'Cough', 'Dysphonia', 'Erythema', 'Immediate post-injection reaction', 'Injection site erythema', 'Injection site pain', 'Pruritus', 'Throat irritation', 'Tongue pruritus', 'Wheezing']",2,PFIZER\BIONTECH,IM 933176,MA,26.0,F,"Worsening tachycardia, shortness of breath on exertion, diaphoresis, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/22/2020,1.0,WRK,,,Presumed COVID-19 dx with persistent tachycardia on exertion,,,"['Condition aggravated', 'Dyspnoea', 'Fatigue', 'Hyperhidrosis', 'Tachycardia']",1,PFIZER\BIONTECH,IM 933177,WA,63.0,F,"Fever 101, chills, sinus pressure, headache, loss of appetite, soreness injection site without redness or swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,"Trintellix, benicar",None,Back pain,,None,"['Chills', 'Decreased appetite', 'Headache', 'Injection site pain', 'Paranasal sinus discomfort', 'Pyrexia']",1,MODERNA,IM 933178,,43.0,F,"Immediately after injection, had headache, nausea, vomiting and metallic taste in mouth. Given 50mg Benadryl with improvement. Nausea/vomiting, metallic taste resolved after 24 hours. Headache and muscle aches lasted 48 hours and improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/10/2021,2.0,WRK,,,,,,"['Dysgeusia', 'Headache', 'Immediate post-injection reaction', 'Myalgia', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 933179,MA,37.0,F,"During the first 15 minutes of vaccine administration my left ear felt blocked with a 2/10 pain. Then the left side of my face started to feel numb from the corner of my left eye to my hairline/ear and down to my chin. the numbness felt like that side of my face fell asleep. this persisted for the evening. I took Benadryl 50mg and claratin. The next day symptoms had improved but were still noticeable. I took an additional dose of 25 mg of benadryl and claratin 10mg. the following day (Tuesday) symptoms had resolved. The day following the vaccine I felt fatigue, nausea and headache. Tueday-Friday following vaccine fatigue and headache has persisted in varying degrees",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,WRK,"yasmin birth control, biotin, multivitamin, vitamin D, vitamin C, probiotic",None,None,,"sulfa, PPD, Implanon, Clindamycin","['Ear discomfort', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Nausea']",1,MODERNA,IM 933180,CA,25.0,F,2 inch diameter painful swelling at injection site. Red and raised skin. Extreme tender/soreness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,OTH,Magnesium Depakote Buspirone Paxil Bupropion Baclofen Promethazine Latuda,,Bipolar disorder,,Codeine,"['Erythema', 'Injection site pain', 'Injection site swelling', 'Tenderness']",1,MODERNA,IM 933181,MA,58.0,F,"Patient c/o lightheadedness with rapid Heart Rate. Handoff to parametics with nurse observing patient. Remained alert and oriented x3, clear speech, without rash/hives. BP 190/118 HR 120 O2 98%.Lungs clear. Continued monitoring patient and at 0655 BP 140/80 HR 85 O2 95%.Family called to pick patient up. Will not be returning to work today.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,"amlodipine, metoprolol, omeprozole and aspirin",,HTN and +Covid in 4/2020,,codeine,"['Dizziness', 'Heart rate increased', 'Impaired work ability']",1,MODERNA,IM 933182,,34.0,M,Headache and muscle and body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,WRK,,,,,,"['Headache', 'Myalgia', 'Pain']",2,PFIZER\BIONTECH,IM 933183,TX,29.0,M,Significant drowsiness began the morning after receiving the vaccine. I was unable to sustain a normal level of activity and slept for more than half of the usual waking hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Sertraline 50mg Lisinopril 2.5mg Claritin Ibuprofen Acetaminophen,N/a,N/a,,Tree nuts Shellfish Melon Avocado Azythromycin,['Somnolence'],UNK,MODERNA,IM 933184,MA,31.0,F,"nausea, feeling flushed, dizzy evaluated by EMTs - VSS and wnl employee continued to feel unwell",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,,,,,,"['Dizziness', 'Flushing', 'Malaise', 'Nausea']",2,PFIZER\BIONTECH,IM 933185,TX,37.0,F,"I developed body aches about 10-11 hours after the vaccine, then fever (100.4F degrees), chills, mild nasal congestion, and mild headache, which lasted for 1-1.5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Zinc, vitamin D, vitamin E, fish oil, and elderberry syrup.",N/A.,Scoliosis.,,Allergic to Hydrocodone.,"['Chills', 'Headache', 'Nasal congestion', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933186,WA,37.0,F,"01/09/2021- noticed mild itching in left upper arm at site of injection. 1/10/2021- worsening itching, scratching and development of hives and 2cm x 3cm warm edematous mass in the left upper arm. No pain and no streaking of erythema.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/09/2021,6.0,UNK,Fish Oil Flaxseed Oil Cetirizine,None,Migraines with Aura,,None,"['Injection site mass', 'Injection site pruritus', 'Urticaria']",1,MODERNA,IM 933790,CA,,F,"30 mins post injection dizziness - given water & reassurance, sm. bag of graham crackers c/o nausea after eating, some (L) arm tingling/numbness 3:01 pm BP 125/81, 92, 99% O2 3:23 pm BP 134/85, 68, 99% O2 Resolved numbness/tingling. Dizziness improved, able to stand",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,WRK,No meds taken-per patient,None,"asthma, intermittent",,NKDA,"['Dizziness', 'Hypoaesthesia', 'Nausea', 'Paraesthesia']",2,PFIZER\BIONTECH,SC 934580,OK,16.0,F,"Patient is 16 yo female. She was given Moderna COVID-19 vaccine during an off-site vaccine POD reserved for First Responders and persons aged 65 and older. She should not have been scheduled for this event and nurse administered vaccine without verifying patient's age. Phone call to patient's mom, to inform of error. Mother states patient has had no side effects or adverse reactions to Moderna COVID-19 vaccine. Informed that patient will not receive second dose in 4 weeks and also is not eligible to receive Pfizer COVID-19 vaccine due to manufacturer's recommendation that vaccie is not interchangeable with other COVID-19 products.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,unknown,unknown,unknown,,unknown,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 934619,MD,45.0,F,"6 cm erythema, inderation + itching at sitse",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,UNK,,,,,Crab,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus']",1,MODERNA,IM 951288,,69.0,F,"RespDepression found to have low potassium Narrative: Patient reports experiencing shortness of breath 24 hours after the vaccine was administered, went to ER and admitted for one night. Informed her supervisor she had low potassium.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,,01/06/2021,,OTH,,,,,,"['Blood potassium decreased', 'Dyspnoea', 'Respiratory depression']",1,MODERNA,IM 964653,,79.0,M,"loss of consciousness; respiratory distress Narrative: Patient tolerated his 1st dose of the COVID-19 vaccine well, on 12/16/2020, and received his 2nd dose on 1/6/2021. Patient had some mild clinical decline the past few days prior to 2nd vaccination, with a decreased appetite and some increased fatigue per nursing report, but no significant changes. He experienced nausea on the evening of 1/6/21, which was effectively managed, but by early morning he spiked a fever of 102.9 with a sat of 86.1%. He continued to deteriorate from that point on and died 1/7/21 @13:20. Clinically, the presentation was most consistent with an aspiration pneumonia.",Yes,01/07/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,OTH,,,,,,"['Death', 'Decreased appetite', 'Fatigue', 'General physical health deterioration', 'Loss of consciousness', 'Nausea', 'Pneumonia aspiration', 'Pyrexia', 'Respiratory distress']",2,PFIZER\BIONTECH,IM 982180,WY,68.0,M,"Sedation, Myalgia, Diarrhea & NASAL CONGESTION",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/24/2020,1.0,OTH,,,,,,"['Diarrhoea', 'Myalgia', 'Nasal congestion', 'Sedation']",2,MODERNA, 982184,,55.0,M,"Headache, Myalgia, Fever, lump under left arm axilla the size of a baseball or bigger, not red, not hot, but very painful, also had chills yesterday, fever was at 102F Narrative: Has appt to see Occ Health provider today to evaluate the lump. Occupational health evaluated the mass, it appears to be fluid filled and may be larger than a baseball, it is substantial, the employee was sent to the ED for further evaluation to rule out infection or other possible diagnosis. Patient will need an ultrasound, CT scan, blood work, etc.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,OTH,,,,,,"['Axillary mass', 'Axillary pain', 'Chills', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933187,MA,56.0,F,"feeling flushed elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta at 5:36 patient reported to be feeling better - drank water - declined transport to ER - felt able/safe to drive home",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,aspirin sertraline amlodipine loratadine rosuvastatin calcium,None,"HTN, HLD, Depression, MI June 2020",,NKA,"['Blood glucose normal', 'Dizziness', 'Electrocardiogram normal', 'Flushing', 'Heart rate increased', 'Nausea']",2,PFIZER\BIONTECH,IM 933188,,65.0,F,"Headache, Muscle aches and chills",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/08/2021,2.0,WRK,,,,,,"['Chills', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH,IM 933189,SC,43.0,F,"Dec 30: Received Moderna vaccine #1 December 31: Onset of injection site tenderness, warmth, swelling, redness Jan 7 delayed reaction reappear at injection site-same as above (site tenderness, warmth, swelling, redness) but now affected area is larger and itchy As of January 10 when composing this submission large area of swelling and redness remain while intermittent itchiness of site area",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,"Protonix, amlodipine, Wellbutrin",None,"GERD, Hypertension",,Arithromycin; azithromycin,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 933190,,26.0,F,Enlarged painful lymph nodes in axilla on arm where vaccine administered. No,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/08/2021,2.0,WRK,,,,,,"['Axillary pain', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 933191,NY,27.0,F,"Temperature of 99 by 11:00 PM on 1/8, had a fever of 101.1 by 5:00 AM on 1/9, fever of 100 continued until 8:00 PM on 1/9",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Lo-Loestrin Fe, Celexa, Buspirone, Xanax XR, Colestid",,"Anxiety, Depression, Irritable Bowel Syndrome, Bile Acid Malabsorption",,Bactrim,['Pyrexia'],UNK,MODERNA,IM 933192,OH,36.0,F,cellulitis in left arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/09/2021,12.0,PVT,,,,,NKDA,['Cellulitis'],1,MODERNA,IM 933193,,34.0,F,"Reporting a temperature at T 100.2, fatigue and Having bronchospasm",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,WRK,,,,,,"['Body temperature increased', 'Bronchospasm', 'Fatigue']",2,PFIZER\BIONTECH,IM 933194,CA,51.0,F,"Started having chills at 11pm, took tylenol 650mg. However, the symptoms not relieved, could not sleep the whole night. fever went up to 101F. Also feeling extreme fatigue, not able to get up from the bed, took another dose 1000mg tylenol, completely lost appetite, body ache. Low grade ever lasted up to 1/8/21. Even now still feeling fatigue and frequent headache. The injection site felt fine two days following injection. But started feeling inlamed and painful on 1/8/21. On 1/9/21, the pain of the site expanded towards the armpit and left upper shoulder and back.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Injection site inflammation', 'Injection site pain', 'Pain', 'Pyrexia', 'Sleep disorder']",UNK,PFIZER\BIONTECH,IM 933195,NY,49.0,F,"Thursday January 7, 2021: Developed a hard lump around the injection site (A week to the day later). Friday January 8, 2021: Arrived at work and around 9:30 felt short of breath. Had pulse and oxygen checked anyway; Pulse 99 (down from 107) and Oxygen 99. Dismissed it as being in my head. Proceeded through my day and it persevered. After lunch, still felt short of breath. Contacted Infection Control nurse and was advised to leave work as it was also a COVID symptom. Went home around 12:15; felt fatigued. Slept all day and night. Saturday January 9, 2021: Minor sore throat, feel as if coming down with a cold. Back of sinuses felt hot upon breathing. Bump at injection site gone completely (I massaged it Thursday and Friday). Minor discomfort with breathing; barely noticeable. In the afternoon time around 2pm, sudden and urgent diarrhea that lasted into the evening hours at bed. Top of stomach burning (inside body). Diarrhea stopped, but nausea remained. At bedtime, still felt as if coming down with a cold. Sunday January 10, 2021: Woke up feeling as if I was getting over a cold. Nose stuffy on the side I slept on. Throughout the day, had the sniffles as the stuffiness went away. Stomach still off; feeling nauseous. No diarrhea (no bowel movement at all). Throughout the afternoon tightness in chest/shortness of breath returned. Towards the evening time still felt as if getting over a cold. Contacted Human Resources and voice appeared hoarse. Ended phone call. Touched my face and noticed a huge lump on my chin that felt like the lump at injection site. Felt like a cyst. About 20 minutes later began to have difficulty swallowing; throat felt tight. Drank a bottle of water and took two allergy pills with antihistamine. An hour and a half after taking these, tightness in throat is still present, but has not progressed any further; in fact, it appears to be slowly fading away. (It's more like the feeling of having a ""lump in your throat"" (but I can't physically feel a lump). The lump on my chin has noticeably diminished in size and is less painful to the touch. COVID test is scheduled for 1/11/21 at 10:30am. It feels as if my body is doing a ""systems check.""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,WRK,Escitalopram 20 mg tab daily Methylphenidate 20mg tab three times daily Active Ginseng (Rejuvica Health) Liquid,None,ADHD,,None,"['Chest discomfort', 'Diarrhoea', 'Discomfort', 'Dyspepsia', 'Dysphagia', 'Dysphonia', 'Dyspnoea', 'Fatigue', 'Injection site mass', 'Malaise', 'Mass', 'Nasal congestion', 'Nausea', 'Oropharyngeal pain']",1,MODERNA,IM 933196,AZ,42.0,F,"5 min - nausea 25 min- Nausea, diaphoretic, wheezing 30 min- Vitals WNL, symptoms resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,UNK,synthroid,,"Childhood asthma, seasonal allergies",,Penicillin,"['Hyperhidrosis', 'Nausea', 'Wheezing']",1,PFIZER\BIONTECH,IM 933197,CA,26.0,F,"Chills, fatigue, rash all over my abdomen, sore arm(injections site)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,UNK,N/a,N/a,No,,Penicillin,"['Chills', 'Fatigue', 'Injection site pain', 'Rash']",UNK,MODERNA,SYR 933198,TX,66.0,F,A lump developed on the top of my left hand between wrist bone and pinkie finger. Noticed it about an hour after injection. No pain. Today is three days later and the lump is still there. Mild sore-type pain and occasionally feels like someone sticking pins around base of the lump. Have not seeked any medical advice.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,"Benazpril, Omeprazole, Gabapentin, Levothyroxine, Sertraline, Metformin, Tylenol",None,None,,"Statin meds, Amoxil, Amoxicilliin","['Pain in extremity', 'Skin mass']",UNK,MODERNA,SYR 933199,TX,30.0,M,"Soreness, hot around the area of the injection. Muscle pains",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,Na,Na,Na,,None,"['Injection site warmth', 'Myalgia', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 933200,CA,31.0,F,"Axillary tenderness on day 6, then gradual worsening of swelling, pain and erythema on left deltoid for a few days after. Then swelling and pain resolved but rash is spreading and now itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PVT,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Rash pruritic', 'Tenderness']",1,MODERNA,IM 933201,CA,41.0,M,On the date of injection. My right arm was fine. Waited 15 mins. Everything was ok. Until 130 am at night. Woke up due to the heart palpitations and nausea that lasted 10-20 mins. Monitor the symptoms and it went away after 20 mins. Symptoms was mild.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,Famotidine,Gerd,,,No,"['Nausea', 'Palpitations']",1,MODERNA,SYR 933202,VA,78.0,F,"8 days after the first vaccine dose, I had itching, swelling, redness, and warmth at injection site on my right upper arm when I woke up in the morning. This is the first day I have had these symptoms. The swelling and redness is about 4 inches in diameter and is very firm. The symptoms have stayed the same all day and the swelling has not gone down yet. I haven?t taken any medication for it or gone to a doctor yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/10/2021,8.0,PUB,"Serevent, Asmanex, levothyroxine,",None,"Asthma, COPD, thyroid removed 15 years ago, elevated cholesterol",,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 933203,CA,60.0,F,"RN administered 1.0 ml delivering 200 mcg, patient was monitored for 30 minutes, no complaints or symptoms reported at time of administration and no symptoms or complaints as of today.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,['Unevaluable event'],1,MODERNA,IM 933206,CO,49.0,M,"Moderna COVID?19 Vaccine EUA - RN administered 1.0 ml delivering 200 mcg, patient was monitored for 30 minutes, no complaints or symptoms reported at time of administration, day 2-3 complaint of severe headache and arm heaviness w/ pain, and no symptoms or complaints days 4-5.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Headache', 'Limb discomfort', 'Pain in extremity']",1,MODERNA,IM 933207,WA,37.0,F,"patient c/o feeling anxious, jittery and worried about vaccine. given H2), 120/80, 84, 98% stayed on site 30 mins. no symptoms or sob. called next day 01/08 1042 am c/o of nausea, chills and fatigue. eating and drinking fluids instructed to call provider if symptoms get worse or 911",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,"c/o feeling anxious, jittery, and no sob 120/80,84 98%, given H2O. pt explained she often has this reaction with vaccines. no hx of adverse reactions/anaphylaxis. stayed fro 30 mins and felt better. called patient 01/08 stated feeling be",none,unknown,,none,"['Anxiety', 'Chills', 'Fatigue', 'Feeling jittery', 'Nausea']",1,MODERNA,IM 933208,CA,80.0,F,"Moderna COVID?19 Vaccine EUA - RN administered 1.0 ml delivering 200 mcg, patient was monitored for 30 minutes, no complaints or symptoms reported at time of administration and no symptoms or complaints as of today.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,OTH,,,,,,['Unevaluable event'],1,MODERNA,IM 933209,CA,36.0,F,"Moderna COVID?19 Vaccine EUA - RN administered 1.0 ml delivering 200 mcg, patient was monitored for 30 minutes, no complaints or symptoms reported at time of administration and no symptoms or complaints as of today.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,OTH,,,,,,['Unevaluable event'],1,MODERNA,IM 933210,TX,24.0,F,"Immediately after receiving the vaccine I felt fine. Around 7 pm that night I began having body aches that continually worsened throughout the night. At 2 am on Saturday I took my temperature and it was 101.6 F, at 3 am it was 102 F. The body aches, joint pain, fever, and headache continued through the next day until about 6 pm on Saturday. Also on Saturday around 12 pm I began experiencing severe nausea, abdominal pain, and dizziness. At one point it felt as if I was going to pass out. All the major symptoms finally subsided Saturday night around 6 pm. Saturday till Sunday I have felt fatigued and sore but otherwise fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,Estarylla Probiotic,,,,,"['Abdominal pain', 'Arthralgia', 'Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,SYR 933211,CA,62.0,M,"Moderna COVID?19 Vaccine EUA - RN administered 1.0 ml delivering 200 mcg, patient was monitored for 30 minutes, no complaints or symptoms reported at time of administration and no symptoms or complaints as of today.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,OTH,,,,,,['Unevaluable event'],1,MODERNA,IM 933212,IA,50.0,M,"Body aches, chills, nausea lasting through January 5th and 6th. Missed work both of these days. Previously had Covid-19 in July 2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PHM,"Omeprazole, 40mg/day; Vitamin D3, 100mcg/day; Fluoxetine, 80mg/day; Multivitamin, 1/day; Metformin, 2000mg/day; Fish Oil 4000mg/day; Tamsulosin, 0.8mg/day; Atorvastatin, 40mg/day",,"OCD, pre diabetes",,"E-mycin, rash; Kelflex, nausia","['Chills', 'Impaired work ability', 'Nausea', 'Pain']",1,MODERNA, 933213,CA,25.0,F,"Bad sore arm for 24 hours Possible migraine/headaches began 2-3 days later unsure if related to the vaccine. I normally don?t get migraines and it?s been lasting ever since, all day and has progressively slowly gotten worse, some very minor nausea at night from the headache. Not even Tylenol extra strength helps the pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,WRK,None,,Asthma,,"Most seafood, kiwi","['Nausea', 'Pain in extremity']",1,MODERNA,IM 933214,WA,65.0,F,"About five days after vaccine administration I noticed an inflammation of the area of the achilles tendon of left foot. Since I am not prone to inflammation of any sort nor did I have any strain or trauma, I took notice. I do not CHF (causing swelling of the ankles). The area of inflammation is tender, a bit red and a bit swollen. It is worrisome since I have never had anything like this in the past. I WILL NEED FOLLOW UP ON THIS. I AM UNSURE IF I SHOULD RECEIVE THE SECOND VACCINE. AND I WOULD LIKE TO KNOW IF SIMILAR INFLAMMATORY RESPONSES HAVE BEEN REPORTED, WHETHER IN ANKLE OR SOMEWHERE ELSE IN THE BODY. I realize that this may not be a typical vaccine reaction BUT this is a brand new vaccine, has not been time-tested, is only permitted by the FDA to be administered under these emergency circumstances. SO all possible reactions must be taken seriously and recorded. We are the guinea pigs. Also. I was handed a packet of papers when I received the vaccine. To register for v-safe the only two options given for registration were smart phone browser or QR code. I do not have a cell phone. So this leaves me out of the loop, which I think is unfair and unwise. Why can computer registration not be made available, and if it can then why doesn't the instruction sheet tell of this? In rural areas not everyone has a cell phone nor is cell service available to all areas.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,PVT,"Levothyroxine 75 mcg, multiple vitamins, vitamin D, Glucosamine, calcium.",none,"Intermittent dizziness, long-standing. Only occassionally","Typical severe flu-like reaction to (Shingles) Shingrix vaccine (both shots 1 and 2).Age 64 at time of vaccine, both administer",NKDA,"['Erythema', 'Inflammation', 'Peripheral swelling', 'Tenderness']",1,MODERNA,SYR 933215,,54.0,F,"I had a normal lump, red (lemon-sized), warm area surrounding the injection site. This occurred within 2-3 days. Within 2-3 more days, the area became more dusky and appeared to be resolving. However, 9 days after the injection, the red area reappeared and was warm to the touch. I called the nurse advice line for the base and they had me get it checked out. (The only open location was the ER at a specific location.) The ER doc advised it was an adverse reaction because it came back after resolving. In addition, he advised to report it to the location that administered the vaccine. I tried to do that, and they advised me to report it here. Note: I have no health insurance and will be financially responsible for that ER visit.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,MIL,prednisone; Cytomel; levothyroxine; Prilosec; Breo ellipta; Flonase; Azelastine spray; Singulair; Zyrtec; Vit D; Iron,"GERD, hypothyroid, asthma","GERD, hypothyroid, asthma",,"e-mycin, narcotics (nausea/vomiting), anesthesia","['Adverse reaction', 'Injection site erythema', 'Injection site mass', 'Injection site warmth']",1,MODERNA,IM 933216,NV,55.0,M,"A few days after first shot, noticed numbness in left little toe which progressed to 3,4,5 digits. After second dose (1-2days later) numbness extended to both feet, all digits, soles, and outside foot",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/22/2020,5.0,PVT,Climdamycin,Prostatitis,,,NKDA,['Hypoaesthesia'],2,PFIZER\BIONTECH,IM 933217,MP,35.0,F,30 minutes of blurred vision with flashes of light.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,OTH,Acetaminophen,Fever,,,,"['Photopsia', 'Vision blurred']",2,PFIZER\BIONTECH,SYR 933218,,41.0,M,Tenderness and swelling at site of injection time 2 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,MIL,,,,,,"['Injection site pain', 'Injection site swelling']",1,MODERNA,IM 933219,MD,36.0,F,"At 4:30pm on Saturday January 9, 2021 I experience a slight fever with chills and back and neck pain. Nothing alarming. I was still able to carry out my normal day activities that included cleaning, tidying, cooking. I did not check my temperature because there was no need, as I said, I could carry on with my day. My arm hurt a lot that day and there was a rectangular red rash around the injection site. That was about the weirdest part at 5:15pm today (Jan 10th, 2021). I noticed this gnarly rash on my chest and back and both shoulders. Red and a little itchy, warm to the touch. It is now 11:50pm same day and the relish has spread to under both of my breasts and down to the bottom of my back. I have pictures of the rash. No fever today. Also, I am both the patient and a member of the vaccination team at my company. My coworker and I are in charge of all admin associated with the vaccine. We are currently vaccinating all our staff. I was the first to get vaccinated in our company. And here it looks like I have an allergic reaction! I have never had an allergic reaction in the past to an injection. I just took some BENADRYL. I'll show a nurse at my clinic tomorrow. Hoping it doesn't spread anymore.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,OTH,Adderall 10mg BID,,"Factor Eleven Bleeding Disorder (diagnosed in 2002), history of Primary Hyperparathyroidism with partial parathyroidectomy in 2014. History of ADHD","Ok, I said I never had an adverse event to an injection before, but I do clearly remember in 2008 getting a flu vaccine and gett",None,"['Back pain', 'Chills', 'Injection site rash', 'Neck pain', 'Pruritus', 'Pyrexia', 'Rash', 'Rash erythematous', 'Skin warm']",1,MODERNA,IM 933220,CA,44.0,F,"Flushing, lump in throat, body aches , fatigue, sore arm, increase BP , increase heart rate after 10-20 mins post vaccine, then mild headache , nausea, metallic taste, dizziness for 3 days , then developed swollen lymph nodes on left supra clavicular area , fever, chills , extreme fatigue on day 4. Increase BP for a week, my BP runs low -my baseline.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Tylenol and Benadryl,Migraine,None,,"Mucomyst, bactrim","['Blood pressure increased', 'Chills', 'Dizziness', 'Dysgeusia', 'Fatigue', 'Flushing', 'Headache', 'Heart rate increased', 'Lymphadenopathy', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test', 'Sensation of foreign body']",1,MODERNA,IM 933221,CO,30.0,F,"About 12hrs after the vaccine was administered, I was at work and wearing nitrile gloves. After 10 minutes, the gloves began burning my hands so badly that I couldn't wear them any longer. I have never had an allergy or an adverse reaction to the gloves I was using. I washed my hands and attempted a different pair of nitrile gloves by a different manufacturer and had the same reaction. I then put on latex gloves, which still caused a burning sensation, but not to the same degree as the nitrile.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/10/2021,0.0,OTH,"Vitamin C, Biotin, Zinc. 150mg Modafinil was taken 36hrs before vaccine",,,,,"['Burning sensation', 'Rubber sensitivity']",1,MODERNA,IM 933222,HI,33.0,F,"Body Aches, Chills, tiredness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,None,End Stage Renal Disease,End Stage Renal Disease,,Keflex,"['Chills', 'Fatigue', 'Pain']",1,PFIZER\BIONTECH,IM 933223,KS,25.0,F,"headache, lightheadedness, vertigo, fever, chills, nausea, stomach cramps, tachycardia. All lasting 18 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,,,,,NKDA,"['Abdominal pain upper', 'Chills', 'Dizziness', 'Headache', 'Nausea', 'Pyrexia', 'Tachycardia', 'Vertigo']",2,PFIZER\BIONTECH,IM 933225,OR,34.0,M,Fatigue with localized soreness at site of injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,,,,,,"['Fatigue', 'Injection site pain']",UNK,PFIZER\BIONTECH,IM 933241,PR,65.0,F,"Numbness of the left side of the face and headache on the left side and part of the tongue; Numbness of the left side of the face and headache on the left side and part of the tongue; The left side of my body, like burning (ankle, elbow); The left side of my body, like burning (ankle, elbow); This is a spontaneous report from a contactable healthcare professional (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular at left arm on 30Dec2020 11:30 at SINGLE DOSE for COVID-19 immunization. Medical history included known allergies to Uva roja. The patient is not pregnant. No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was in the Doctor's office/urgent care. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) included atorvastatin (LIPITOR) and fexofenadine hydrochloride (ALLEGRA). The patient previously took titanium and experienced allergies. On 30Dec2020 , the patient experienced numbness of the left side of the face and headache on the left side and part of the tongue. The left side of patient's body, like burning (ankle, elbow). No treatment received for the events. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the events was recovered on unspecified date. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,LIPITOR [ATORVASTATIN]; ALLEGRA,,Medical History/Concurrent Conditions: Fruit allergy,,,"['Arthralgia', 'Burning sensation', 'Headache', 'Hypoaesthesia']",1,PFIZER\BIONTECH,OT 933252,TX,,M,"Bell's Palsy; This spontaneous report was received from a lawyer concerning a case in litigation and refers to currently 70 year old male patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On or about 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions. On an unknown date (reported as ""subsequently""), the patient experienced bell's palsy (facial paralysis), and was treated with unspecified medications. The outcome of facial paralysis was unknown. The reporter considered facial paralysis to be related to Zoster Vaccine Live (ZOSTAVAX). Upon internal review, the event of bell's palsy was considred medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Facial paralysis'],UNK,MERCK & CO. INC., 933254,AZ,,F,"She stated that she had a cyst develop on her arm from the pneumonia vaccine that had to be surgically remove; anaphylactic reaction to Pneumovax; This spontaneous report as received from a 68 years old female retired medic via Pfizer referring to herself. The patient had a significant allergies to food related, nitrate plants and medications. The patient was allergic to tomato, potato, eggplant, cayenne, chili pepper, paprika, whole wheat, egg albumin, aluminum, baclofen, diphenhydramine hydrochloride (BENADRYL), benzene (BENZOL), clindamycin, and so on. The patient had an allergic reaction to egg component of influenza virus vaccine (unspecified). The patient was immunocompromised and had multiple sclerosis. The patient was taking immunosuppressants and interferon beta-1a (AVONEX). In approximately January 2011 (reported as 10 years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. In approximately January 2011 (reported as 10 years ago), the patient had an anaphylactic reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The patient received self medicating with an antihistamine. On an unknown date, the patient had a cyst develop on her arm from the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine that had to be surgically removed. The outcome of anaphylactic reaction and cyst was unknown. The reporter considered the causal relationship between anaphylactic reaction and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was related. The causality assessment between cyst and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported. Upon internal review, anaphylactic reaction was determined to be medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2011,01/01/2011,0.0,UNK,AVONEX,"Allergy to aluminium; Allergy to plants (nitrate plants); Allergy to vaccine; Drug hypersensitivity; Food allergy (allergic to tomato, potato, eggplant, cayenne, chili pepper, paprika, whole wheat, egg albumin); Hypersensitivity; Immunocompromised; Multiple sclerosis",,,,"['Anaphylactic reaction', 'Cyst', 'Cyst removal']",UNK,MERCK & CO. INC., 933255,PA,,U,"meningitis; pneumonia; cardiovascular event; congestive heart failure; postherpetic neuralgia; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about 27-JUL-2016, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date after the vaccination, the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, meningitis, pneumonia, cardiovascular event and congestive heart failure. As a result of these symptoms, patient was seen and treated by medical providers and was still under their care. As a result of vaccine live(ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient also had incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of above events was considered as not recovered. The reporter considered the events to be disable and related to Zoster Vaccine Live(ZOSTAVAX). Upon internal review, meningitis, pneumonia and congestive heart failure were determined to be medically significant.",Not Reported,,Not Reported,Not Reported,,Yes,N,07/27/2016,,,UNK,,,,,,"['Cardiac failure congestive', 'Cardiovascular disorder', 'Herpes zoster', 'Meningitis', 'Pneumonia', 'Post herpetic neuralgia']",UNK,MERCK & CO. INC.,OT 933259,TX,,U,"bullous pemphigoid; This case was reported by a physician via sales rep and described the occurrence of bullous pemphigoid in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the bullous pemphigoid was unknown. It was unknown if the reporter considered the bullous pemphigoid to be related to Shingrix. Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected adult as per vaccine indication. The patient developed bullous pemphigoid after receiving the Shingrix vaccine. The permission to follow up was denied. This case has been linked with US2021AMR001850, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR001850:same reporter",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pemphigoid'],UNK,GLAXOSMITHKLINE BIOLOGICALS, 933260,TX,,U,"bullous pemphigoid; This case was reported by a physician via sales rep and described the occurrence of bullous pemphigoid in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the bullous pemphigoid was unknown. It was unknown if the reporter considered the bullous pemphigoid to be related to Shingrix. Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected adult as per vaccine indication. The patient developed bullous pemphigoid after receiving the Shingrix vaccine. The permission to follow up was denied. This case has been linked with US2021AMR001842, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR001842:same reporter",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pemphigoid'],UNK,GLAXOSMITHKLINE BIOLOGICALS, 933261,CT,31.0,M,"Chills; Fever; Loss of consciousness x 2; GI upset; Diarrhea; Difficulty sleeping; Pallor; Stomach flu; A spontaneous report was received from a nurse concerning a 31-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of consciousness (LOC) x 2, gastrointestinal (GI) upset, diarrhea, difficulty sleeping, pallor, stomach flu, chills and fever. The patient's medical history, as provided by the reporter, included allergy to cefaclor and hereditary hemorrhagic telangiectasia. Concomitant medications reported included desvenlafaxine succinate, gabapentin and dexlansoprazole. On 23 Dec 2020 at 11:30 am, approximately six hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the morning of 23 Dec 2020, prior to receiving mRNA-1273, the patient felt ""achy"". At 5:30 pm, the patient experienced chills, fever to 102, GI upset and diarrhea. At 11:00 pm, the patient reported difficulty sleeping, GI upset, LOC x 2 and pallor. The patient was transported to the emergency room via ambulance. A COVID-19 polymerase chain reaction test and routine labs were collected; however, results were not provided. Treatment for the events included paracetamol, unspecified intravenous (IV) medications, ondansetron and ketorolac tromethamine. The emergency room discharge diagnosis was stomach flu. Action taken with mRNA-1273 in response to the events was not reported. The events, loss of consciousness (LOC) x 2, GI upset, diarrhea, difficulty sleeping, pallor, stomach flu, chills and fever, were considered resolved on 24 Dec 2020.; Reporter's Comments: This case concerns a 31-year-old, male subject with a medical history of hereditary hemorrhagic telangiectasia, who experienced the unexpected events of loss of consciousness (LOC) x 2, gastrointestinal (GI) upset, diarrhea, difficulty sleeping, pallor, and stomach flu, and the expected events of chills and fever. The events of chills, fever occurred approximately 6 hrs. and the events of GI upset, loss of consciousness, difficulty sleeping occurred after 12 hrs. after the first dose of Moderna COVID-19 Vaccine. The time to onset for the events of GI upset and diarrhea were unknown. The reporter did not provide the causality assessment for the events. Due to the temporal association between the LOC and the administration of the vaccine, a causal relationship cannot be excluded, however, the subject's medical history of hereditary hemorrhagic telangiectasia and other concurrent conditions of GI upset, diarrhea, and stomach flu remain as confounders.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,UNK,PRISTIQ; GABAPENTIN; DEXILANT,Drug allergy (Ceclor),Medical History/Concurrent Conditions: Hereditary hemorrhagic telangiectasia,,,"['Abdominal discomfort', 'Chills', 'Diarrhoea', 'Gastroenteritis viral', 'Insomnia', 'Loss of consciousness', 'Pallor', 'Pyrexia']",1,MODERNA,OT 933262,VA,,F,"Sharp shooting pain up my arm, upper chest, the shoulder, above my brest; Trouble swallowing, slurred speech, red across the chest and hoarse/raspy voice; A report was received from a consumer concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced sharp shooting pain up my arm, upper chest, the shoulder, above my brest, trouble swallowing - could not swallow my saliva, slurry speech, red across my chest, and hoarse/raspy voice. The patient's medical history included diphenhydramine hydrochloride allergy, shellfish allergy, and latex allergy. Concomitant medications included salbutamol sulfate. The patient received their first dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection in their right arm on 26 Dec 2020. Five minutes following administration of the vaccine, the patient felt sharp shooting pains up her arm, upper chest, the shoulder, above the breast. Five to 10 minutes after, the patient had trouble swallowing and began to have slurred speech. The patient was administered epinephrine in her right thigh. Following this, she began to experience redness across the chest and was administered another dose of epinephrine. She also experienced hoarse/raspy voice. The patient was then transported to the emergency room in an ambulance, where she received intravenous fluids and solumedrol after which she began feeling better. The patient was observed in the hospital for several hours and discharged on the same day. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, sharp shooting pain up my arm, upper chest, the shoulder, above my brest, was unknown. The event, trouble swallowing - could not swallow my saliva, was considered resolved on 26 Dec 2020. The outcome of the event, slurry speech, was unknown. The outcome of the event, red across my chest, was unknown. The outcome of the event, hoarse/raspy voice, was unknown. The reporter did not provide an assessment for the events, sharp shooting pain up my arm, upper chest, the shoulder, above my brest, trouble swallowing - could not swallow my saliva, slurry speech, red across my chest, or hoarse/raspy voice.; Reporter's Comments: This case concerns a female patient with a medical history of diphenhydramine hydrochloride allergy, shellfish allergy, and latex allergy who experienced the events of pains up her arm, upper chest, the shoulder, hypersensitivity reaction with symptoms of trouble swallowing, slurred speech, erythema of the chest and hoarse/raspy voice, occurring between five and ten minutes following administration of the first dose of mRNA-1273 vaccine. The patient was treated with 2 shots of epinephrine, was transported to the hospital and received and IV solumedrol, after which symptoms improved. Based on the information provided and temporal association, the event is assessed as possibly related to mRNA-1273. The patient's medical history of multiple allergies could have contributed to the event. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/26/2020,0.0,UNK,VENTOLIN [SALBUTAMOL SULFATE],Drug allergy (Benadryl); Latex allergy; Shellfish allergy,,,,"['Arthralgia', 'Chest pain', 'Dysarthria', 'Dysphagia', 'Dysphonia', 'Erythema', 'Pain', 'Pain in extremity']",1,MODERNA,OT 933265,CA,26.0,F,"generalized itchiness; woke up with headache; feeling fatigued; anaphylactic reaction; right arm started going numb; right arm was tingling; A spontaneous report was received from a 26-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, right arm numbness and tingling, headache, fatigue, and generalized itchiness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: OU520A/011520A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 23 Dec 2020, within minutes of receiving the vaccine, the patient experienced an anaphylactic reaction and was rushed to the emergency room (ER). When transported to the ER she began to experience throat swelling, redness of arms and chest, trouble breathing with lower chest pain shooting into lungs, and numbness with tingling in her right arm. Treatment for the event included epinephrine, steroids, and diphenhydramine. She was released from the ER on 23 Dec 2020. On 24 Dec 2020 patient awoke with a headache, fatigue, and generalized itchiness. Treatment for the event included ibuprofen and diphenhydramine. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, anaphylactic reaction, right arm numbness and tingling, were reported as resolved on 23 December 2020. The events of headache, fatigue, and generalized itchiness were considered resolving.; Reporter's Comments: This case concerns a 26-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot OU520A/011520A), and who experienced the unlisted events of anaphylactic reaction, right arm numbness and tingling, and generalized itchiness, and the listed events of headache and fatigue. The events were considered to be possibly related to the vaccine due to the temporal relationship with onset on the day of vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Anaphylactic reaction', 'Chest pain', 'Dyspnoea', 'Erythema', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Pain', 'Paraesthesia', 'Pharyngeal swelling', 'Pruritus', 'Pulmonary pain']",1,MODERNA,OT 933266,CA,,F,"Anaphylactic reaction; Chest pressure; Rash (on neck,belly and arm); Metallic taste in mouth; Hot flashes; Headaches; A spontaneous report was received from a 49-year-old female nurse, who was also a patient, who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headaches. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, at 7:00 pm, approximately 15 minutes prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly, for prophylaxis of COVID-19 infection. On 22 Dec 2020, approximately 15 minutes after the mRNA-1273 vaccination, the patient experienced anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headaches. She was taken immediately to the emergency room. Laboratory values included a negative troponin level and low potassium at 3.3. All other laboratory results were normal. Treatment included prednisone for five days, diphenhydramine hydrochloride, famotidine and paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events, anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headaches was not reported The causality assessment for the events, anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headache was not reported.; Reporter's Comments: This case concerns a 49-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), reporting an unexpected event of anaphylactic reaction, chest pressure, rash, metallic taste in mouth, hot flush and an expected event of headache. The events occurred the same day, 15 minutes after vaccine administration. The reporter did not provide the causality assessment for the events. Due to the temporal association between the events and administration of the vaccine, a causal relationship cannot be excluded, and the events are assessed as possibly related to vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Anaphylactic reaction', 'Blood potassium decreased', 'Chest discomfort', 'Dysgeusia', 'Headache', 'Hot flush', 'Rash', 'Troponin normal']",1,MODERNA,OT 933268,,,F,"Anaphylactic type of reaction; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic type of reaction. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, after receiving the Moderna vaccine, patient reported that she had some adverse side effects and believed she needed an Epi-pen before getting a second dose due to the anaphylactic type of reaction she had. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, anaphylactic type of reaction, was not reported.; Reporter's Comments: This case concerns a female patient of unreported age. The patient's medical history is not provided. The patient experienced an unexpected event of anaphylactic type of reaction. The event occurred on an unknown date and unknown duration after receiving the first dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the event, a causal relationship cannot be excluded. Additional information about the event details are required for further assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Anaphylactoid reaction'],1,MODERNA,OT 933269,,,F,"itching in her arms, face, neck and her trunk; redness of the skin; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable physician reported that a 23-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from Dec2020 at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that this patient was given the first dose of COVID-19 vaccine within the last week. The patient experienced itching in her arms, face, neck and her trunk, redness of the skin with no airway problem after her first dose (Dec2020). Patient took Benadryl for the symptoms and they went away completely within minutes. The patient was told that they cannot get the second shot. So the doctor wanted to find out if that information was true or not; if they could get that second shot. Outcome of events was recovered. No follow-up attempts possible. No further information expected. The following information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Erythema', 'Pruritus']",UNK,PFIZER\BIONTECH, 933270,,35.0,F,"nasal swab test positive; This is a spontaneous report from a contactable physician (the patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date unknown ) via an unspecified route of administration on 22Dec2020 (at the age of 35-years-old) at an unspecified dose for COVID-19 vaccination. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient had a nasal swab test the day before her vaccine and did not receive the results prior to getting her injection. The results came back positive. The patient underwent lab tests and procedures which included sars-cov-2 test on 21Dec2020 which was positive. The clinical outcome of COVID-19 test positive was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,UNK,,,,,,"['SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 933271,,,M,"I developed symptoms on 29Dec2020 and test obtained on 30Dec2020. My results are back today and I'm positive.; I developed symptoms on 29Dec2020 and test obtained on 30Dec2020. My results are back today and I'm positive.; This is a spontaneous report from a contactable other HCP (healthcare professional) who reported for himself. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 16Dec2020 (at an unspecified age) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient tested positive for coronavirus on 30Dec2020. It was reported that the patient obtained his first Pfizer vaccine dose on 16Dec2020. The patient reported that he was a physician assistant and worked in a dedicated COVID patient care area. The patient developed symptoms on 29Dec2020, and a test was obtained on 30Dec2020. The patient's results were back ""today"" and he was positive. The patient was scheduled for his second dose of the vaccine on 06Jan2021. He reported that he would cancel that because he would still be in his 10-day isolation period. Given those circumstances, the patient inquired as to ""when would be the most ideal time to obtain my second dose of the vaccine? When should I take my second dose of the vaccine if I contracted COVID after receiving the first dose?"" The clinical outcome of the event ""I developed symptoms on 29Dec2020, and test obtained on 30Dec2020. My results are back today and I'm positive"" was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on a compatible temporal asociation, a causal relationship between event ""patient developed symptoms on 29Dec2020 and test obtained on 30Dec2020. was positive"" (coded to Drug ineffective / COVID-19) and BNT162B2 vaccine cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/30/2020,14.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 933272,,,U,"person then became symptomatic and tested positive within 7 days of receiving the vaccine; person then became symptomatic and tested positive within 7 days of receiving the vaccine; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (at an unknown age) at an unknown dose for COVID-19 vaccination. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient became symptomatic and tested positive within seven (7) days of receiving the COVID-19 vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The clinical outcome was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 933273,OH,37.0,F,"Complete loss of smell and taste; Complete loss of smell and taste; This is a spontaneous report from a contactable physician reported for herself. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: PfizerbioNtech, lot number: EH9888) intramuscularly at left arm on 17Dec2020 at 03:00 PM at a single dose (dose number: 1) for COVID-19 immunization. Medical history was reported as none. No known allergies (no allergies to medications, food, or other products). The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse event complete loss of smell and taste on 19Dec2020 at 07:00 AM. The event was considered as serious due to resulted in disability or permanent damage. No treatment received for the event. The outcome of event was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events complete loss of smell and taste cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/17/2020,12/19/2020,2.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Ageusia', 'Anosmia']",1,PFIZER\BIONTECH,OT 933274,OK,37.0,F,"Stomach cramps; frequent loose stools; GI issues; This is a spontaneous report from a contactable physician, the patient. A 37-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 16Dec2020 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient had no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 16Dec2020 at 21:30 the patient experienced gastrointestinal issues, stomach cramps and frequent loose stools reported as beginning several hours after the vaccination and lasting until the next day. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the gastrointestinal issues, stomach cramps and frequent loose stools was resolved on 17Dec2020. Information on the Lot/Batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,PVT,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: other medical history: No",,,"['Abdominal pain upper', 'Diarrhoea', 'Gastrointestinal disorder']",1,PFIZER\BIONTECH,OT 933275,OH,47.0,F,"ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consumer reported for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number: EK5730; dosage form: injection) via an unspecified route of administration as injection to left arm on 24Dec2020 at 7:30 am at a single dose for COVID-19 immunization. Relevant medical history and concurrent conditions included slight hypertension from Jul2020 and ongoing. Concomitant medications included lisinopril from Jul2020 and ongoing for slight hypertension. The patient developed ball palsy, facial dropping which did not lasted long but she still had the painful shingles on 27Dec2020, after the first dose. She wanted to know the recommendations for taking the second dose which is due in 10 days. The patient wanted to know if she should receive the shingles vaccine. This caller was a lab tech who works in the healthcare industry and manages a medical office; but clarified she did not call on behalf of a healthcare professional. She was the patient who received her first dose of Pfizer SARS-CoV-2 Vaccine on 24Dec2020. She reported onset of what the Urgent Care Physician believed was Shingles on 27Dec2020. She called to ask if she should or should not receive the second dose of Pfizer SARS-CoV-2 Vaccine on 14Jan2021 as scheduled due to the Shingles. The Urgent Care Physician advised her to still get the second dose, as there was about a 1:10,000 chance of developing shingles with the vaccine. She reported shingles as a reaction subsequent to the Pfizer SARS-CoV-2 Vaccine. Initially on 27Dec2020 she developed sites of what she thought were canker sores or fever blisters in her mouth which had gotten pretty large and stopped her from being able to eat on 29Dec2020. Then on 30Dec2020 she developed sites on her face which have gotten scarily large; and was causing some deep nerve pain going to her eye and down her chin; the sites felt like lesions on her face with roots. The sites in her mouth were now completely gone; but the sites on her face are ongoing. Now it has kind of taken over her face. She saw the Urgent Care Physician regarding this who believed the sites to be shingles. She had never had fever blisters or shingles before this event. She was still kind of reeling. The report was reported as non-serious. The outcome of event ball palsy/facial dropping was resolved and of shingles was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/27/2020,3.0,UNK,,Hypertension,,,,"['Aphthous ulcer', 'Facial paralysis', 'Feeding disorder', 'Herpes zoster', 'Neuralgia', 'Oral herpes', 'Pain', 'Skin lesion']",1,PFIZER\BIONTECH, 933276,,,F,"received the Covid 19 vaccine/then tested positive for the virus/symptomatic; received the Covid 19 vaccine/then tested positive for the virus/symptomatic; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Dec2020 at a single dose as Covid 19 vaccine. Medical history and concomitant medications were not reported. It was reported that the patient received the Covid 19 vaccine on 17Dec2020 and then tested positive for the virus on an unspecified date. She was scheduled to have the second vaccine on 07Jan2021, but she was not able to go to work because she's still symptomatic. She would like to know if there's an extension to the 21 days since she has the virus now. The outcome of the events was unknown. Information about Lot/Batch number is requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,,,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 933277,NV,39.0,F,"developed UTI very quickly; Puffy face and eyes; Puffy face and eyes; Burning inside digestive tract; Diarrhea; Dehydrated; arm pain; Headache; At bedtime neck stiffness began and worsened; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246/expiration date unknown), dose number 1, via an unspecified route of administration on 02Jan2021 10:30 at a single dose on the left arm for COVID-19 immunization. The patient had no relevant medical history. Concomitant medications included alprazolam (XANAX). The patient experienced arm pain and headache 4 hours post injection requiring Excedrin. At bedtime, neck stiffness began and worsened. She was treated with lidocaine patches and Aleve. She developed diarrhea 33 hours post injection. She went ER because she was dehydrated. She developed UTI very quickly by hour 35 post injection. She had puffy face and eyes, and burning inside her digestive tract. She was treated with Benedryl at home for allergic reaction, Toradol for pain, IV fluids for dehydration and Keflex for infection. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 since vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Dehydration cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,UNK,XANAX,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Abdominal discomfort', 'Dehydration', 'Diarrhoea', 'Headache', 'Hypersensitivity', 'Musculoskeletal stiffness', 'Pain in extremity', 'Periorbital swelling', 'Swelling face', 'Urinary tract infection']",1,PFIZER\BIONTECH, 933278,WA,34.0,F,"felt a rush of dizziness to my head / felt a little lightheaded all day; heart started racing over 150 bpm; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140), via an unspecified route of administration in the left arm on 04Jan2021 08:00 at a single dose for COVID-19 immunization. The patient's medical history included overweight and elevated cholesterol. The patient had no known allergies to medications, food, or other products. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 04Jan2021 08:00, the patient felt a rush of dizziness to her head a few minutes after receiving the injection and then her heart started racing over 150 bpm. It calmed down after a few minutes although she have felt a little lightheaded all day. No treatment was received for the adverse event. The events were considered non-serious by the reporter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Blood cholesterol increased; Overweight,,,"['Dizziness', 'Heart rate', 'Heart rate increased']",1,PFIZER\BIONTECH, 933279,WA,35.0,F,"swollen lymph node, right side of neck; caused pain when swallowing; This is a spontaneous report from a contactable other healthcare professoonal (patient). A 35-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140), via an unspecified route of administration in the right arm on 29Dec2020 11:30 at a single dose for COVID-19 immunization. The patient's medical history included chronic asthma and allergy to animal dander, mold, pollen. The patient was not pregnant. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), bupropion hydrochloride (WELLBUTRIN), ethinylestradiol, etonogestrel (NUVARING), salbutamol sulfate (PROAIR), and OTC vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took erythromycin and experienced drug allergy to erythromycin. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. 1 day after vaccination, on 30Dec2020 08:00, the patient woke up with swollen lymph node, right side of neck. Between 30Dec2020 and 04Jan2021, it increased in size and caused pain when swallowing. On 04Jan2021, the patient sought care at local emergency room (ER) due to concerns that it may be blocking esophagus. The patient underwent lab tests and procedures which included computerised tomogram (CT scan) with unknown results on 04Jan2021. Therapeutic measures were taken as a result of the events and included treatment with intravenous antibiotic. Outcome of the events was not recovered. The events were considered non-serious by the reporter. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,WRK,ADVAIR; WELLBUTRIN; NUVARING; PROAIR [SALBUTAMOL SULFATE],,Medical History/Concurrent Conditions: Allergy to animal dander; Allergy to molds; Asthma chronic; Pollen allergy,,,"['Computerised tomogram', 'Lymphadenopathy', 'Odynophagia']",1,PFIZER\BIONTECH, 933280,,,F,"at the injection site, there is a small hole in it and it is still bleeding; at the injection site, there is a small hole in it and it is still bleeding; severe headache/headache is a pain; This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on Dec2020 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient verbalized, ""I received the vaccine 2 and 1/2 weeks ago. At the injection site, there is a small hole in it and it is still bleeding. Is this a common side effect? I had a severe headache the next day, and it seemed to get less than the past week and 1/2 to 2 weeks it's back again, a constant headache. I've been taking Tylenol but doesn't seem to go away. I did go get a COVID test to make sure and that should be back in a few days. It's weird that the injection site is still bleeding and with the headaches. The injection site hole healed up. I couldn't see the injection a week afterwards but it opened up again and continuous bleeding here and there again. It doesn't look infected, doesn't look red. The headache is a pain."" The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results on an unspecified date. Therapeutic measures were taken as a result of severe headache that included Tylenol. Clinical outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Headache', 'SARS-CoV-2 test', 'Vaccination site haemorrhage', 'Vaccination site injury']",UNK,PFIZER\BIONTECH, 933281,,,F,"doesn't have full function of left shoulder; nerve entrapment from the incorrect administration; The person who injected the vaccine into the joint space and not the deltoid; This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated she received the first dose of the vaccine on 21Dec and the person who injected the vaccine into the joint space and not the deltoid. The patient stated that she doesn't have full function of left shoulder because of nerve entrapment from the incorrect administration and asked if she is able to get the other dose somewhere other than her deltoid muscle. Clinical outcome of the events was unknown. Information on lot/batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Arthropathy', 'Nerve compression', 'Product administered at inappropriate site']",UNK,PFIZER\BIONTECH, 933282,,,F,"vomited; diarrhea; a severe headache; severe muscle pain; severe fatigue like being ""beat up in a bar""; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot and expiry not reported), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 29Dec2020, patient experienced a severe headache, severe muscle pain and severe fatigue; further reported as like being ""beat up in a bar"" for over 1 week. It was also reported that the patient vomited and experienced diarrhea on an unspecified date. The patient was also inquiring if there is difference between the symptoms in dose 1 and 2. Outcome of events was unknown. Information of lot and batch number has been requested.; Sender's Comments: Based on the available information and known BNT162B2 vaccine safety profile, a causal relationship between events severe headache, severe muscle pain and severe fatigue and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,UNK,,,,,,"['Diarrhoea', 'Fatigue', 'Headache', 'Myalgia', 'Vomiting']",UNK,PFIZER\BIONTECH, 933283,CA,62.0,M,"Bell's Palsy; This is a spontaneous report from a contactable physician (patient). A 62-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on left arm on 19Dec2020 19:00 at single dose for COVID-19 immunisation. Known allergies: No. Other medical history: None. No other vaccine in four weeks. No other medications in two weeks. The patient experienced bell's palsy on 03Jan2021 21:00 and required visit to physician office. Covid test type post vaccination: Nasal Swab (PCR) on 29Dec202: Negative. Therapeutic measures were taken as a result of bell's palsy included Prednisone, Valtrex. Outcome of event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on a compatible association, causality between event Bell's palsy and BNT162B2 vaccine cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,01/03/2021,15.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Facial paralysis', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,OT 933284,,,M,"Tested positive with covid 19 with symptoms; Tested positive with covid 19 with symptoms; This is a spontaneous report from a contactable healthcare professional. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated, ""I received the covid 19 vaccine on 22Dec; was supposed to have 2nd dose on 12Jan2021. Tested positive with covid 19 on 01Jan2021 with symptoms. I want to know how long I need to wait to get the second dose"".The outcome of the events was unknown. Information on the lot number has been requested.; Sender's Comments: Although, BNT162B2 vaccine immunogenicity is not in full effect after short time (10 days in this case) of first dose administration, a causal relationship between event ""Tested positive with covid 19 with symptoms"" (coded to Drug ineffective / COVID-19) and BNT162B2 vaccine cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,01/01/2021,10.0,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 933285,TX,44.0,F,"difficulty breathing; woke with 102 fever; Body aches; injection site soreness; Fatigue/extreme fatigue; This is a spontaneous report from a contactable healthcare professional. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular in right arm on 30Dec2020 13:00 at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior vaccination. The patient experienced fatigue, injection site soreness day of vaccine, following extreme fatigue on 30Dec2020 16:00. Five days after (04Jan2021), woke with 102 fever, body aches, fatigue, and difficulty breathing. The events resulted in doctor or other healthcare professional office/clinic visit. The events were treated with an unspecified antibiotic. The patient underwent lab test and procedures which included nasal swab and Rapid Saers on 04Jan2021 with negative results. The outcome of the events was not recovered. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Asthma,,,"['Body temperature', 'Dyspnoea', 'Fatigue', 'Investigation', 'Pain', 'Pyrexia', 'SARS-CoV-2 test', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 933286,AR,,M,"received covid vaccine then contracted covid-19, 9 days after getting the vaccine; received covid vaccine then contracted covid-19, 9 days after getting the vaccine; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on Dec2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was stated, ""received covid vaccine then contracted covid-19, 9 days after getting the vaccine, should he get his 2nd dose which is on Friday? Tested positive on the 30th, received monoclonal antibody infusion on the 31st. Any information regarding this?"". The outcome of the event was unknown. Information on the lot number has been requested.; Sender's Comments: Although, BNT162B2 vaccine immunogenicity is not in full effect after short time (9 days in this case) after first dose administration, a causal relationship between event ""received covid vaccine then contracted covid-19"" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/30/2020,29.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 933287,NY,,F,"Bell's palsy/Face was turning side ways; This is a spontaneous report from a contactable nurse. A female patient of unspecified age received BNT162B2 (reported as ""Covid-19 Vaccine, manufacturer: Unspecified"", Batch/lot number: not provided) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. A woman received a Covid vaccine. She did not know which one. The woman experienced Bell's Palsy. The woman was crying and her face was turning sideways. Outcome of the event was unknown. Pfizer is a marketing authorization holder of Covid-19 Vaccine in the country of incident or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Covid-19 Vaccine has submitted the same report to the regulatory authorities. Information on the Batch/Lot number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between reported event Bell's Palsy and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Crying', 'Facial asymmetry', 'Facial paralysis']",UNK,PFIZER\BIONTECH, 933288,NJ,65.0,M,"Cheek swelling; Periorbital swelling/swelling around his eyes; feeling wiped out; Muscle pain; Joint pain; Chills; Fever; General malaise; low grade headache; Sweating; injection site pain; This is a spontaneous report from a contactable physician (patient). A 65-year-old male patient received bnt162b2 (BNT162B2) at single dose at left deltoid on 02Jan2021 17:00 for covid-19 immunisation, administered an injection team that is part of the local hospital system. Medical history included controlled hypertension and he has been taking the blood pressure medicine for a long time. The concomitant medications included unspecified medicines for controlled hypertension. History of all previous immunization with the Pfizer vaccine was none. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. No additional vaccines administered on same date of the BNT162B2 vaccine. On 02Jan2021 the patient experienced injection site pain. On 03Jan2021 the patient experienced cheek swelling, periorbital swelling/swelling around his eyes, feeling wiped out, muscle pain, joint pain, chills, fever, general malaise, low grade headache, sweating. No event did require a visit to Emergency Room or Physician Office. No relevant tests performed. Therapeutic measures were taken as a result of chills, fever, general malaise, low grade headache, sweating. Course of events: He said initially he had no adverse events after receiving the COVID-19 Vaccine, except injection site pain. He said he thought the injection site pain could be from the COVID-19 Vaccine being viscous, and didn't think anything else about the injection site pain. On 03Jan2021 he started to experience some. He stated he did not normally take vaccines, like the flu vaccine. He said he has been a podiatrist for 39 years, and realized the importance of getting the vaccine to protect his patients. He then developed chills, muscle pain, fever, and general malaise. He said he experienced every side effect listed on the received COVID-19 Vaccine paperwork, except he had no lymphadenopathy. He said all the side effects he experienced appeared 24 hours to the minute from when he received the COVID-19 Vaccine. On 03Jan2021, he had swelling in his cheeks and around his eyes. He did not get sick often. He said he had a rough night on 03Jan2021 and on 03Jan2021 he still felt wiped out. Treatment: he took 2 Tylenol 325mg at the start of the side effects, and then took another 2 Tylenol 325mg at 2:00AM. He said he woke up soaking wet with chills and sweats. He said his fever broke, but he did not know how high his fever was. He took from a fresh bottle of Tylenol 325mg. The outcome of injection site pain, cheek swelling, periorbital swelling/swelling around his eyes, feeling wiped out, muscle pain, joint pain, general malaise was recovering, of chills, fever, sweating was recovered in Jan2021, of low grade headache was not recovered. The reporter considered there was a reasonable possibility that all events were related to bnt162b2 vaccine. He was scheduled to receive another COVID-19 Vaccine injection in 3 weeks. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Hypertension (controlled hypertension and he has been taking the blood pressure medicine for a long time),,,"['Arthralgia', 'Chills', 'Feeling abnormal', 'Headache', 'Hyperhidrosis', 'Malaise', 'Myalgia', 'Periorbital swelling', 'Pyrexia', 'Swelling face', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 933289,,45.0,F,"Left nostril stopped up; Sinus pressure in head; Pressure in head; Burning sensation in both arms and in her left knee/both of her thighs swollen, burning and itching on both knees; Hives on both arms and left knee; both of her thighs swollen, burning and itching on both knees; Burning and itching on both knees; neck feels like someone is sitting on the back of it/Left side neck pressure and throbbing; Left side neck pressure and throbbing; Lower back spasms; This is a spontaneous report received from a contactable consumer. A 45-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, in Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the vaccine in Dec2020 (reported as ""Thursday""). She began experiencing symptoms on Friday (as reported). Her left nostril stopped up and had sinus pressure in her head. On Saturday and Sunday (as reported), her left nostril was not stopped up but still had pressure in her head. On Monday (as reported), she began to feel burning sensation in both arms and in her left knee. When the patient was de-gowning PPE while at work, she found hives on both arms and left knee. She took BENADRYL and applied cold compress to site. Later Monday (as reported), she woke up to both of her thighs swollen, burning and itching on both knees. Her neck feels like someone is sitting on the back of it. She experienced left side neck pressure and throbbing and lower back spasms. The patient would like to know if these symptoms have been reported and what should she do. The outcome of the event ""left nostril stopped up"" was recovered on an unspecified date; ""sinus pressure in head"" and ""pressure in head"" was not recovered; and the outcome of the remaining events was unknown. Information on lot/batch number for the product has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,,,UNK,,,,,,"['Burning sensation', 'Head discomfort', 'Muscle spasms', 'Musculoskeletal discomfort', 'Nasal congestion', 'Neck pain', 'Paranasal sinus discomfort', 'Peripheral swelling', 'Pruritus', 'Urticaria']",UNK,PFIZER\BIONTECH, 933290,,,U,"memory care patients received Pfizer-BioNTech covid vaccine, and then were diagnosed with COVID, all three had COVID symptoms; memory care patients received Pfizer-BioNTech covid vaccine, and then were diagnosed; This is a spontaneous report from a contactable other health professional. This reporter reported same events for three patients. This is first of three reports. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech COVID vaccine), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The memory care patient received Pfizer-Biontech Covid vaccine, and then was diagnosed with Covid and had Covid symptoms on an unspecified date, the patient was scheduled to receive monoclonal antibody. Event took place after use of product. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to possibly short number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information,Linked Report(s) : US-PFIZER INC-2021004747 same reporter/product/event, different patient;US-PFIZER INC-2021004748 same reporter/product/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 933291,,,U,"Diagnosed with COVID; Diagnosed with COVID; This is a spontaneous report from a contactable other health professional. This reporter reported same events for three patients. This is second of three reports. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech COVID vaccine), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The memory care patient received Pfizer-Biontech Covid vaccine, and then was diagnosed with Covid and had Covid symptoms on an unspecified date, the patient was scheduled to receive monoclonal antibody. Event took place after use of product. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to possibly short number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information,Linked Report(s) : US-PFIZER INC-2021004746 same reporter/product/event, different patient;US-PFIZER INC-2021004748 same reporter/product/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 933292,,,U,"Diagnosed with COVID; Diagnosed with COVID; This is a spontaneous report from a contactable other health professional. This reporter reported same events for three patients. This is 3rd of three reports. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech COVID vaccine), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The memory care patient received Pfizer-Biontech Covid vaccine, and then was diagnosed with Covid and had Covid symptoms on an unspecified date, the patient was scheduled to receive monoclonal antibody. Event took place after use of product. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: There is limited information reported, it is possible patient would have taken only single dose, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information,Linked Report(s) : US-PFIZER INC-2021004746 same reporter/product/event, different patient;US-PFIZER INC-2021004747 same reporter/product/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 933293,CA,41.0,F,"cheeks were swollen; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; so tired; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the left arm on 26Dec2020 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included allergic reaction with known allergies to sulfa, seafood. Concomitant medications included acetylsalicylic acid/caffeine/salicylamide (EXCEDRIN) and paracetamol (TYLENOL). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, ""I just finished a night shift from work and got home on 02Jan2021 around 07:45 when I brushed my teeth, I felt a severe burning sensation inside my mouth and the inside of my mouth started to swell. I didn't think much of it since I was so tired but then woke to get ready to work then my mouth and cheeks were swollen (02Jan2021 at 16:00) and barely could open my mouth."" No treatment was provided for the events burning mouth, mouth swelling, cheeks were swollen and so tired. The outcome of the events burning mouth, mouth swelling, cheeks were swollen and so tired was not recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/02/2021,7.0,PVT,EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;SALICYLAMIDE]; TYLENOL,,"Medical History/Concurrent Conditions: Allergic reaction (Field Name: other medical history Field Value: Allergic reaction); Seafood allergy (Field Name: known allergies Field Value: Sulfa, seafood); Sulfonamide allergy (Known allergies: Sulfa, Seafood)",,,"['Fatigue', 'Mouth swelling', 'Oral discomfort', 'Swelling face']",1,PFIZER\BIONTECH,OT 933294,,30.0,F,"Slight pain at the injection site; sore/tender muscles on the left side of the body (mainly shoulder & neck); soreness/stiffness in left hip; soreness/stiffness in left hip; fatigue; This is a spontaneous report from a contactable pharmacist, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL1284) solution for injection intramuscular in the left arm on 31Dec2020 at 12:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no relevant medical history. There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01Jan2021, the patient experienced slight pain at the injection site, sore/tender muscles on the left side of the body (mainly shoulder & neck), some soreness/stiffness in left hip, and fatigue. No treatment was provided for the events slight pain at the injection site, sore/tender muscles on the left side of the body (mainly shoulder & neck), some soreness/stiffness in left hip, and fatigue. The outcome of the events slight pain at the injection site, sore/tender muscles on the left side of the body (mainly shoulder & neck), some soreness/stiffness in left hip, and fatigue was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PHM,,,,,,"['Arthralgia', 'Fatigue', 'Joint stiffness', 'Myalgia', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 933295,TN,,M,"had a positive test for COVID; had a positive test for COVID; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable physician who reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had a PCR COVID-19 swab performed on 23Dec2020 which returned positive on 26Dec2020. The action taken in response to the event for bnt162b2 was not applicable. Outcome of the event was unknown. Information for lot number has been requested in follow up activity.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/23/2020,4.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 933296,,,M,"numbness; tingling; This is a spontaneous report from a non-contactable Nurse, the patient. This male patient of unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced numbness and tingling from the shoulder to the feet on the side the injection was given. The clinical outcome of the events numbness and tingling was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Hypoaesthesia', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 933297,IL,,M,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a non-contactable pharmacist via Pfizer Sales Representative. A 25-year-old male patient (nurse) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown as did not have this information), via an unspecified route of administration in Dec2020 (reported as received either 17Dec2020 or 18Dec2020) at single dose for COVID-19 immunization in hospital. The patient's medical history and concomitant medications were not reported. One of the reporter's employees (patient) got the COVID-19 Vaccine. Ended up testing positive for COVID probably due to patient care. Patient was taking care of two to three people who were not positive for COVID while in the hospital, but tests came up as positive. Patient developed symptoms in Dec2020 and tested positive for COVID on 24Dec2020. Patient received COVID-19 Vaccine either 17Dec2020 or 18Dec2020. Began coughing three to four days after vaccination in Dec2020. Rapid test was negative in Dec2020. On 24Dec2020, the M20 test came back as positive for COVID. Only other symptom patient experienced was loss of taste and smell in Dec2020. Had been a stressful situation for the patient. The outcome of the events was unknown. Information on the Lot/ Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,PVT,,,,,,"['Ageusia', 'Anosmia', 'Cough', 'Occupational exposure to SARS-CoV-2', 'SARS-CoV-2 test positive', 'Stress']",UNK,PFIZER\BIONTECH, 933298,,28.0,F,"myalgias; Headache; nausea; chills; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, intramuscularly on 17Dec2020 at 10:30 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) from an unspecified date, for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Dec2020 at 16:30, the patient experienced headache, nausea, chills, myalgias. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the headache, nausea, chills, myalgias was resolved on an unspecified date in 2020. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,LO LOESTRIN FE,,,,,"['Chills', 'Headache', 'Myalgia', 'Nausea']",1,PFIZER\BIONTECH,OT 933299,,,U,"encephalitis; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient was allergic to UTI(urinary tract infection) infection medication (i.e. sulfamethoxazole, trimethoprim etc.). Concomitant medications were not reported. The patient got encephalitis and was put in the ICU(intensive care unit) after getting vaccinated, led to hospitalization. Outcome of event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,Drug allergy,,,,"['Encephalitis', 'Intensive care']",UNK,PFIZER\BIONTECH, 933300,PA,53.0,F,"Left arm pain; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL0142, intramuscularly in the left arm on 04Jan2021 at 09:45 (at the age of 53-years-old) as a single dose for COVID-19 immunization. Medical history included an allergy to sulfa, from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 04Jan2021 at 09:45 the patient experienced left arm pain. The patient was not treated for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left arm pain was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,['Pain in extremity'],1,PFIZER\BIONTECH,OT 933301,WA,40.0,F,"24 hours later sever dizziness; Injection site soreness; Internal itching; This is a spontaneous report from a contactable Other HCP. A 40-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), intramuscular on 04Jan2021 10:00 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date. Anatomical location was left arm. The patient experienced internal itching on 04Jan2021 10:15, 24 hours later severe dizziness on 05Jan2021, injection site soreness on 04Jan2021 10:15. The patient underwent lab tests and procedures which included covid-19 test on 05Jan2021 (unknown result). The events outcome was unknown. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,,,Medical History/Concurrent Conditions: Diabetes,,,"['COVID-19', 'Dizziness', 'Pruritus', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 933302,TN,81.0,F,"Dizzy; Nauseous; Unable to breath; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot unknown, via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunisation. Medical history included blood pressure increased. Concomitant medication included sertraline (UNKNOWN MANUFACTURER) for high blood pressure. On an unspecified date the patient experienced dizzy, nauseous and was unable to breath. The patient still had those symptoms and was wondering if it was normal and how much longer will these symptoms be. The outcome of the events was not resolved. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,,,UNK,,,Medical History/Concurrent Conditions: Blood pressure increased,,,"['Blood pressure measurement', 'Dizziness', 'Dyspnoea', 'Nausea']",UNK,PFIZER\BIONTECH, 933303,,,F,"Having some pain at the injection site; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable female consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced having some pain at the injection site on an unspecified date. She had one dose and she was having some pain at the injection site and basically she was wondering if she should be using, she should use heat or cold for that. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 933304,,,U,"pain in arm, kind of at the site of injection; specifically when I lift my arm a little bit up, I get pain in that area; pain in arm, kind of at the site of injection; specifically when I lift my arm a little bit up, I get pain in that area; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: ""pain in arm, kind of at the site of injection; specifically when I lift my arm a little bit up, I get pain in that area"" (non-serious). The clinical course was reported as follows: The patient reported that they received the first dose of the ""vaccine of Pfizer"" (name not clarified) on 23Dec2020. The patient reported that they were still experiencing ""pain in my arm, kind of at the site of the injection but specifically when I lift my arm a little bit up, I get pain in that area and that has been like since I got the shot."" The patient wanted to know if they should be concerned about getting the second vaccine. The clinical outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,,,UNK,,,,,,"['Pain in extremity', 'Vaccination site pain']",1,PFIZER\BIONTECH, 933305,FL,,F,"Anaphylactic shock; Initial information was received on 30-Dec-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (patient). This case involves a female patient (age unspecified) who had an anaphylactic shock, after she received INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date in 2011, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious anaphylactic shock (unknown latency), following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. As a result of this, she had been advised not to take the pneumonia shot, shingles shot, flu shots, in case they contain a common element that was present in the 2011 flu shot. Her question was simply due to the fact that she was afraid to take any further vaccines, especially the Coronavirus disease 2019 (COVID-19). No laboratory data was provided. It was not reported if the patient received a corrective treatment. At the time of report, the outcome of event was not reported. Information on batch number was requested for this case.; Sender's Comments: This case concerns a female patient (age unspecified) who had an anaphylactic shock after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Anaphylactic shock'],UNK,UNKNOWN MANUFACTURER,OT 933307,,,M,"Anaphylactic reaction to neomycin in a flu vaccine; This spontaneous case was received on 29-Dec-2020 from pharmacist via agency (reference number: SEQW20-05972) and concerned a male patient of an unknown age. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified, dose, route of administration and anatomical location: not reported) for influenza prophylaxis. Batch number was not reported. On an unspecified date, after receiving influenza virus vaccine polyvalent, the patient experienced anaphylactic reaction to neomycin in a flu vaccine. On an unspecified date, the patient recovered from the event 'anaphylactic reaction to vaccine'. The reporter assessed event as related to influenza virus vaccine polyvalent, as it was reported that the patient had anaphylactic reaction to neomycin in a flu vaccine. The reporter assessed event as serious due to criterion of medical significance. Company comment: A patient of unknown age was vaccinated with influenza virus vaccine polyvalent. On an unspecified date, after receiving influenza virus vaccine polyvalent, the patient experienced anaphylactic reaction to neomycin in a flu vaccine. Causality is assessed as possibly related. Brighton Collaboration criteria could not be assessed due to insufficient information.; Reporter's Comments: The patient had anaphylactic reaction to neomycin in a flu vaccine.; Sender's Comments: A patient of unknown age was vaccinated with influenza virus vaccine polyvalent. On an unspecified date, after receiving influenza virus vaccine polyvalent, the patient experienced anaphylactic reaction to neomycin in a flu vaccine. Causality is assessed as possibly related. Brighton Collaboration criteria could not be assessed due to insufficient information.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Comments: None,,,"['Allergy to vaccine', 'Anaphylactic reaction']",UNK,UNKNOWN MANUFACTURER,OT 933308,OR,30.0,M,"Severe fatigue, malaise, and muscle cramping. Lasted 48 hours, started to resolve after the initial 24hr.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,,,,,,"['Fatigue', 'Malaise', 'Muscle spasms']",1,PFIZER\BIONTECH,IM 933309,,47.0,F,"""Moderna COVID-19 Vaccine EUA"" Within 15 ins of injection throat was draining, felt scratchy and sore. Headache, fatigue, joint pain, lymph nodes under arm were very painful for about week. And of course pain at injection site. On 09 Jan 2021 a red rash appeared and itching. It is also warm to the touch on left arm at or around the injection site. (concerned about this sense it appeared a week later.) Did not have this for a week. After all the symptoms went away.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,MIL,Synthroid atorvastatin aspirin,no,no,,erythromycin,"['Arthralgia', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site warmth', 'Lymph node pain', 'Oropharyngeal pain', 'Pruritus', 'Rash erythematous', 'Sinus operation', 'Throat irritation']",1,MODERNA,IM 933310,,41.0,F,"Severe headache with photosensitivity, soreness at injection site, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,UNK,,,,,,"['Headache', 'Injection site pain', 'Malaise', 'Photosensitivity reaction']",1,PFIZER\BIONTECH,IM 933311,,42.0,F,5 minutes following tingling in my lips and tongue. Later that night my tongue felt thick and the tingling progressed from the tip to the back of by tongue.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,SEN,Advil HCTZ Losartan,,,,Shellfish,"['Hypoaesthesia oral', 'Paraesthesia oral', 'Tongue disorder']",1,PFIZER\BIONTECH,IM 933313,CA,32.0,M,"chills, migraine, cotton mouth, whole body muscle aches, congestion. Was woken up by chills and head. Went to shower and sat in hot shower for 25-30 minutes. got out. chills returned, got back in shower for 10 minutes. took excedrin and then went back to bed with heat blanket.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,excedrin.,congestion,none.,,none,"['Chills', 'Dry mouth', 'Headache', 'Migraine', 'Myalgia', 'Pain', 'Respiratory tract congestion']",2,PFIZER\BIONTECH,IM 933314,PR,49.0,F,"FEVER, HEADACHE, SHIVERS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,,,,,,"['Chills', 'Headache']",UNK,PFIZER\BIONTECH, 933315,NY,48.0,F,"Body aches, generalized fatigue, hyperglycemia, 10lb weight loss, lightheadedness, headaches, swelling at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,"Metformin, gemfibrozil, carvedilol, enalapril, baby aspirin, fish oil, red rice yeast, cinnamon",none,"Type 2 diabetes mellitus, hypertriglyceridemia, diastolic heart failure, hypertension",,None,"['Dizziness', 'Fatigue', 'Headache', 'Hyperglycaemia', 'Influenza virus test negative', 'Injection site swelling', 'Pain', 'SARS-CoV-2 test negative', 'Weight decreased']",1,MODERNA,IM 933318,IL,26.0,F,"CHILLS, LOW GRADE FEVER AND BODY ACHES. SYMPTOMS LASTED 8 HOURS AND SUBSIDED RELATIVELY QUICKLY.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,NONE,NONE,NONE,,NONE,"['Chills', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 933319,FL,71.0,F,"After receiving the vaccine client verbalized tachycardia, dizziness and light headedness. Client was evaluated by onsite paramedic. Client was transported to Clinic for further evaluation due to unresolved symptoms at 4:24 pm. In addition client verbalized no allergies when asked by intake nurse.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/10/2021,01/10/2021,0.0,PUB,None,None,Neuralgia,,"Sulfa, codeine, morphone","['Dizziness', 'Tachycardia']",1,PFIZER\BIONTECH,SYR 933320,IN,35.0,F,I woke up the following morning with a headache but otherwise fine. I took some ibuprofen and received some relief but then began to have nausea and loss of appetite until about 6pm. Beginning around noon I had severe chills without fever and extreme fatigue. These lasted until about 9pm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,"Vitamin D, magnesium, turmeric",,,,,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Nausea']",2,PFIZER\BIONTECH,IM 933321,PR,38.0,F,Patient present flushing after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/01/2020,0.0,PVT,No,Unknown,Unknown,,Unknown,['Flushing'],1,PFIZER\BIONTECH,IM 933322,FL,75.0,F,Client verbalize tingling of the tongue and mild swelling of the lips after receiving the vaccination. Client was evaluated by onsite paramedic and physician. 9:55 am client symptoms resolved and release at 10:03 am. Accompanied by daughter.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/10/2021,01/10/2021,0.0,PUB,None,None,"Mild kidney disease, HTN, GERD, Diabetes II, History of breast cancer",,Sulfa,"['Lip swelling', 'Paraesthesia oral']",1,PFIZER\BIONTECH,SYR 933323,FL,66.0,F,"1/9/21-17:15- started having chills, muscle pain. Pain L arm(injection site) 18:00- low grade temp 99.3, muscle pain arms and legs worse Uncomfortable during the entire night (tossing and turning) 1/10/21- 07:30-General malaise(flu like symptoms)- muscle pain-feeling weak T-99 started feeling better during the late afternoon, still with muscle pain , T-98.7",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Rosuvastatin 20 mgs HS Anastrozole 1mgs Ritual multivitamins,Breast Cancer,Arthritis,,NKA,"['Asthenia', 'Body temperature decreased', 'Chills', 'Influenza like illness', 'Injection site pain', 'Malaise', 'Myalgia', 'Pain in extremity', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 933324,IL,29.0,F,"Chest pain at 1/10/2021 at 9:18pm - 9:25pm nothing provoked this dull pain in center of chest. Sitting in a chair before and after it stopped. New onset of itching, redness, and swelling at the injection site on 1/11/2021 at 0530 am. No other swelling, itching, redness anywhere else.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/10/2021,6.0,PVT,Prenatal vitamins,N/a,N/a,,"Amoxicillin, penicillin, azithromycin, bee/wasp stings","['Chest pain', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 933325,ME,49.0,F,"Later that night I got a sever headache, and some chills. Lasted for about 4 -5 hours, and injection site sore for 2 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,"lomaira, vitamine d, b12",,factor 5,,"intolerance to latax, codine, amatriptoline, chocolate and peanut butter can give me migraines.","['Chills', 'Headache', 'Injection site pain']",1,MODERNA,SYR 933326,FL,77.0,F,"After receiving the vaccine, she verbalize feeling different in her head and headache. She was evaluated onsite by Fire Rescue and Dr. onsite and released home at 10:50 am feeling better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PUB,Zinbatobin,"HBP, Palpitatioins",None,,none,"['Feeling abnormal', 'Headache']",1,PFIZER\BIONTECH,IM 933327,IN,38.0,F,"Extreme headache causing inability to keep eyes open, extreme body aches all over, hot/cold flashes, bed ridden for 30 hours, extremely sore arm, had to use ice packs and IBprofrin for head and arm pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,"Amlodipine Besylate 5 MG TAB (1 a day), Sertraline HCL 100 MG Tablet (2 a day), Losartan-HCTZ 100-12.5 MG TAB (1 a day), Timed Release Melatonin 10 mg (1 a day), Diphendydramine 25 mg (1 a day), Omeprazole DR 20 MG Capsule (1 a day), biotin",Bronchitis and HBP.,"High Blood Pressure, Hypertension",,Darvacets,"['Asthenopia', 'Bedridden', 'Feeling cold', 'Headache', 'Hot flush', 'Pain', 'Pain in extremity']",1,MODERNA,SYR 933328,TX,53.0,M,"severe shortness of breath, tachycardia, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Uroxatral,none,bph,,none,"['Blood gases', 'Chest X-ray', 'Dyspnoea', 'Pyrexia', 'SARS-CoV-2 test', 'Tachycardia']",2,PFIZER\BIONTECH,IM 933329,MD,49.0,M,"On Saturday evening 1/9/2021 I started to have a moderate reaction to my vaccine that I received on 1/3/2021, I started to itch from head to toe with rash in multiple areas of my body. I was able to control the reaction/symptom with Benadryl 50mg every 6 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/09/2021,6.0,PVT,"lisinopriL 40 MG tablet, zolpidem 3 mg tablet",none,none,,Iodine (shell fish reaction),['Pruritus'],1,MODERNA,SYR 933330,ME,37.0,F,"got vaccine completed 1/5/2021, waiting 20 minutes to check for reaction. Drove back to work. By the time i got back to work I had a very itchy rash from just above injection site on my left arm down to my belly. This rash finally went aware mid day on 1/6/2021 and i also had Nausea from the night of 1/5/2021 to 1/9/2021. I contact my Employee Health Department when i returned to work 1/7/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,none,none,Lupus,,"Keflex, Aspirin, Prednisone, Grapes","['Pruritus', 'Rash', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 933334,PA,53.0,F,"Extreme chills, Fever 102.2, Headache across forehead, body aches, cough",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,"Levothyroxine, Celexa, Advair (generic), Vitamin D, Melatonin","Migraines, week prior","Asthma, Hypothyroid",,Penicillin,"['Chills', 'Cough', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 933335,TN,25.0,M,"Developed a headache about 4 hours after injection. Face, neck, shoulder, upper arms were red in color which lasted about 8 hours. Took Benadryl and Tylenol felt better and redness went away.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"Claritin, Albuterol",None,"Asthma, Allergic Rhinitis","He has had significant arm swelling and upper body redness with the Flu Vaccine at around age 22, but did not have a reaction th",NKDA or food allergies,"['Erythema', 'Headache']",1,PFIZER\BIONTECH,IM 933336,MI,44.0,F,"My left arm was red, swollen, & hot to the touch for two days. I noticed the arm was swollen, but the redness went away. Six days later I scratcedh my arm because it was itchy. The next 3 days my left arm was swollen, red, & hot to the touch again. I was advised to see a doctor. I am currently being treated for cellulitis at the site of my injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/05/2021,7.0,PVT,Fenofibrate 134 mg Escitalopram 10 mg Lansoprazole 30 mg Calcium Supplements Adult Multivitamin,No,Hyperlipidemia Heart Murmur Obesity,,Penicillin Sulfa Alka Seltzer Cold & Sinus Grass Dust,"['Injection site cellulitis', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA,IM 933337,NY,39.0,F,Arm pain at injection site. Fatigue and muscle aches for 24 hours. Swelling in armpit/lymph nodes on injection site arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,Probiotics Birth control Antacid Zinc supplement,None,None,,Doxycycline,"['Fatigue', 'Injection site pain', 'Lymphadenopathy', 'Myalgia']",2,PFIZER\BIONTECH, 933338,IL,22.0,M,"After receiving the second round of my Pfizer COVID vaccine, approximately an hour and a half later I received a rash on my right bicep and across my abdomen going slightly onto my back and I became itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PVT,,,,,,"['Pruritus', 'Rash']",2,PFIZER\BIONTECH,SYR 933339,CT,45.0,F,Swelling and pain in left armpit/lymph nodes,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/08/2021,4.0,WRK,none,none,none,,none,"['Axillary pain', 'Lymph node pain', 'Lymphadenopathy', 'Swelling']",1,MODERNA,SYR 933340,MA,53.0,F,A 1/2 hour after receiving vaccine my fast started to tingle and it lasted almost 24 hours. I have had Bell's Palsy in the past (30 years ago),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,WRK,"Synthroid, Atorvostatin, Meftformin, Daily Vitamin, Vitamin D",,Hypothyroidism,,,['Paraesthesia'],1,PFIZER\BIONTECH,IM 933341,AZ,33.0,M,"Hearing loss to right ear and bad metatarsals/wrist joint pain. I worked 12 hrs night shift, around 0500, I started having joint pain on right wrist with minimal swelling. When I got home, I slept and woke up around 3PM, I started feeling my right ear can?t hear, seems like I have a swimmers?s ear, I have applied OTC swimmer?s ear drops to help resolve it but no success.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/10/2021,6.0,UNK,None,None,None,,None,"['Arthralgia', 'Deafness unilateral']",1,MODERNA,IM 933343,GA,,U,"Migraine, high fever,sore throat, chills,ear ache, toothache, body aches, can't swallow,can't eat",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,PUB,,,,,,"['Chills', 'Decreased appetite', 'Ear pain', 'Influenza virus test negative', 'Migraine', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Streptococcus test negative', 'Toothache']",1,PFIZER\BIONTECH,SYR 933344,GA,27.0,F,"I woke up in the middle of the night with chills, body aches, nausea, and over all weakness. I ended up throwing up. I only got 4 hours of sleep.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,OTH,,,,,Sulfa,"['Asthenia', 'Chills', 'Insomnia', 'Nausea', 'Pain', 'Vomiting']",2,PFIZER\BIONTECH,SYR 933345,CA,51.0,F,"36 hours of intense pain all over , fever , rigors, visible swelling of joints , swollen lymph node in armpit of left arm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,None,None,None,,"Sulfa , latex , shellfish","['Chills', 'Joint swelling', 'Lymphadenopathy', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933346,PA,40.0,F,"0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started to feel chest get tight and began wheezing 0850- went home - itchy on chest stomach, back, and chin/throat. Still very red. 0915- took Benadryl did breathing treatment- cold pack to face 1015- itchy- less- headache, no wheezing no nausea- fell asleep 1215- woke up- chest tight- did breathing treatment- headache 1515- took another 25mg Benadryl Slept most of day til next morning. Went to work 12/29/21 at 6am by 12 feeling really under the weather and tired. Went home took Motrin600mg and went to bed . 12/30 went to work back to normal",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"Symbicort, Lexapro, Singulair",,Asthma,flu shot- increased asthma symptoms,"bananas, avocados","['Chest discomfort', 'Erythema', 'Fatigue', 'Feeling hot', 'Headache', 'Malaise', 'Nausea', 'Pruritus', 'Somnolence', 'Throat irritation', 'Wheezing']",1,PFIZER\BIONTECH,IM 933348,OH,57.0,F,"Exacerbated Lupus flare-up to include severe muscle ache, joint stiffness, fatigue, headache for approximately 24 hours. Experienced heart palpations a couple of different occasions while at rest (sitting) in the 3-4 days following.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Hydroxychloroquine, nabumetone, luflonomide, miracle 2000, fish oil, magnesium citrate, probiotic, maca powder,",none,Lupus,,"peanuts, chicken, fish, citrus fruits, tomatoes, plastics, latex","['Antiphospholipid antibodies', 'Fatigue', 'Headache', 'Joint stiffness', 'Myalgia', 'Palpitations', 'Systemic lupus erythematosus']",1,MODERNA,IM 933349,MI,51.0,F,Had muscles aches headache and some neck pain 15 mins after vaccination. Patient is still currently having these symptoms. Headaches and body aches have worsened.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2012,01/06/2021,3288.0,PVT,,,,,,"['Headache', 'Myalgia', 'Neck pain', 'Pain']",UNK,PFIZER\BIONTECH, 933350,,35.0,F,"Patient had severe nausea, moderate headache all over head while in the observation room.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PVT,,,,,Gluten,"['Headache', 'Nausea']",2,PFIZER\BIONTECH,IM 933351,ME,62.0,F,"Starting on 01/09/2021 at 02:00am woke up nauseous and hot. Body aches especially r arm with tingling in r hand, dizziness and chills throughout the day They would come and go. Late afternoon, Biceps went into spasms all fingers aching. After nap at 06:00 woke up and all symptoms gone. On 01/10/2021, woke up with tingling and burning from bilateral knees to toes. Lasted 2 hours and then gone. In afternoon 1 episode of dizziness and hot flashes followed by chills. 01/11/2021 Slight headaches. No bodyaches or other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Ibuprofen, Vitamin D, Magnesium, acetaminophen",None,Degenerative Disc Disease,,"Prozac, Effexor, Melatonin","['Burning sensation', 'Chills', 'Dizziness', 'Feeling hot', 'Hot flush', 'Muscle spasms', 'Nausea', 'Pain', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 933352,FL,38.0,F,"Allergic reaction at site of injection, started approx 2-3 days after and worsening. Circular erythema, mild edema, itching, warmth. Seen at hospital urgent care 1/10/21 and prescribed MEDROL DOSE PACK and ice/heat regimen. Also instructed to take OTC BENADRYL.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/05/2021,3.0,PVT,"2 hours prior took routine meds including modafinil, HCTZ, propranolol, citalopram, Junel",None,"DM2, HTN, OSA with excessive daytime somnolence, depression, morbid obesity, HLD",,None,"['Injection site erythema', 'Injection site hypersensitivity', 'Injection site oedema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 933353,NJ,59.0,F,Moderna COVID-19 Vaccine EUA Soreness near injection site lasted two days. Chills lasted first afternoon. Bad taste in mouth started 30 minutes after vaccination and lasted six hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,Gall stones,,Latex sensitivity (not allergy),"['Chills', 'Injection site pain', 'Taste disorder']",1,MODERNA, 933356,MD,44.0,F,"I started having a ""twitching"", numbing feeling above my lip on the left side.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PUB,none,none,"Hives when in cold temperatures, have had this condition since birth. Hypothyroidism",,"Allergy to Penicillin. Hives when in cold temperatures, have had this condition since birth.","['Hypoaesthesia oral', 'Muscle twitching']",1,MODERNA,IM 933357,GA,37.0,F,"Fever max 104.7, not below 102.1 for over 24 hours with OTC fever reducers. HR 125-135 for >24 hours, chills, fatigue, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PUB,"Propranolol, Zinc, Magnesium, Vit D, Zyrtec, Albuterol",None,Asthma,,"Outdoor allergens, Latex","['Chills', 'Dizziness', 'Fatigue', 'Pyrexia']",UNK,MODERNA,IM 933358,IL,37.0,F,"Chills started on 11/8. Then on 11/09 whole head felt like is was going fo explode, lymph nodes behind ears and ears felt like going to pop, arm hurt down into elbow and still had chills. By 11/10 felt 95% better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,,None,Exercised induced asthma,,"Latex, bananas","['Chills', 'Ear discomfort', 'Head discomfort', 'Lymph node pain', 'Pain in extremity']",1,MODERNA,IM 933359,,34.0,F,"extreme body aches and fever aprox 24 hours after vaccine, lasting aprox 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,none,none,DM,,Loritab,"['Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933360,TX,32.0,F,Soreness to Left arm lasted for 48 hrs Fatigue started 12 hrs after and lasted for 36 hrs,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,SEN,"Vit B12 injections, Vit C, Vit D, Zinc, Iron, Prozac",,"Iron def anemia, OCD, Vit D def.",,"Bactria DS, honey bees","['Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 933361,IN,52.0,F,"red knot on arm, hands and feet joint pain, chills, fatigue, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Lexapro 10 mg, Norvasc 5 mg, HCTZ 25 mg, potassium OTC, esomeprazole 20 mg, vitamin D3 1000 mcg, women's 50+ MVI",Positive for COVID 12/3/20,,,"Imitrex, penicillin, latex","['Arthralgia', 'Chills', 'Erythema', 'Fatigue', 'Headache', 'Nodule', 'Pain in extremity']",1,MODERNA,IM 933362,IN,44.0,F,"N/v, severe headache, diarrhea, body ache, large knot on arm with rede ness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,Prozac Protonix Probiotic,Colonized cDiff,Diabetes,,Pcn,"['Diarrhoea', 'Erythema', 'Headache', 'Nausea', 'Nodule', 'Pain', 'Vomiting']",1,MODERNA,IM 933363,KY,34.0,F,"Vaccine received on 12/30/20, reaction reported on 01/11/2021 to left upper arm swollen, red, warm to touch area has gotten larger over the past 2 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/09/2021,10.0,PVT,,,,,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 933364,MA,35.0,F,"Arm erythema, warmth, tenderness, edema with axillary lymph node tenderness consistent with cellulitis.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,01/02/2021,6.0,PVT,"Celexa, IUD",None,None,,"Penicillin, keflex","['Erythema', 'Lymph node pain', 'Oedema', 'Skin warm', 'Tenderness']",1,MODERNA,IM 933365,KY,30.0,F,"Chest Congestion, Nose congestion, Nose bleeds, Chills, Body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,UNK,,,,,,"['Chills', 'Epistaxis', 'Nasal congestion', 'Pain', 'Respiratory tract congestion']",UNK,MODERNA, 933366,FL,70.0,F,"Chest pain b/p 176/79 11.25 First at 11:17 am b/p 166/70 11.30, 185/76, 165/74 11.21",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,None,,PCN,['Chest pain'],1,PFIZER\BIONTECH,IM 933367,MI,45.0,F,Swollen lips and face hives on face,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PVT,"HCT, venlafaxine, Claritin",None,Controlled hypertension,,None,"['Lip swelling', 'Urticaria']",1,PFIZER\BIONTECH,SYR 933368,CT,27.0,F,severe body aches for about 36 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,"Lexapro, Wellbutrin, xyzal",,,,,['Pain'],2,PFIZER\BIONTECH, 933369,MN,56.0,F,Anaphylactic reaction,Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Albuteral, Loratadine, Fmotidine, Prednisone, Levothyroxine, Epipen (prn)",None,"Migraine headaches, History of papillary thyroid carcinoma, Latex allergy",,Latex,['Anaphylactic reaction'],UNK,PFIZER\BIONTECH, 933370,IN,65.0,M,"Chills, headache, aches, fatigue, swollen arm, erythema,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Olmesartan-hctz, pantoprazole, flonase, benadryl, pravastatin,",,"HTN, exercised induced asthma, allergic rhinitis, ascending aortic aneurism",,none,"['Chills', 'Erythema', 'Fatigue', 'Headache', 'Pain', 'Peripheral swelling']",1,MODERNA,IM 933371,TN,59.0,F,"sore throat, headache, swelling and very, very sore feeling in the left arm, tingling in the tips of fingers (feeling pricked in the fingertips).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,"Levothryroxin, Valsartan-HZT, Metformin, Vit D., Vitamin C, Amlodipine","was recovering from ankle surgery done on October 5, 2020","diabetes, high blood pressure","flu shot- age 49 or so, was very ill from the flu shot",none,"['Headache', 'Oropharyngeal pain', 'Pain in extremity', 'Paraesthesia', 'Swelling']",1,PFIZER\BIONTECH,IM 933372,ME,58.0,F,Developed severe and debilitating dizziness and nausea on Sunday Jan 3rd and lasted through Sunday Jan 10th. Even today I have lingering vertigo.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/03/2021,10.0,WRK,Labetalol Lipitor Losartan Potassium baby aspirin Flonase Claritin,none,"HTN, migraines",,"seasonal allergies, animals","['Dizziness', 'Nausea', 'Vertigo']",1,MODERNA,SYR 933373,OH,45.0,F,"Arm began to itch badly in the evening. The next morning the whole deltoid area was red, hot and hard. The itch has been intermediate, and the redness and heat is still present. The pattern of redness has shifted, but is still large.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,PVT,"Wellbutrin, Flonase, Multivitamin (Hair, Skin & Nails), Vit B complex, Vit D, Saw Palmetto & Biotin supplement, Cortisol Health supplement with Ashwagandha and Phosphatidylserine, Trentinoin (Retinol) topical, Minoxidil topical",,,,"Prozac, Penicillin, topical dermatitis","['Erythema', 'Induration', 'Pruritus', 'Skin warm']",1,MODERNA,IM 933374,PR,56.0,F,01/05/2021 Warmth inside the body and cold outside the body. Rigid jaw I could not open it completely and in the vaccination area it turned red and with a protuberance. 01/06/2021 when ingest food the chewing made difficult the chewing process I bit my cheek on the inside throughout the day. Itching in the right arm throughout the day. 01/07/2021 the tongue felt enlarged and I had to keep my mouth half open so it did not stick to the palate. 01/08/2021. On this day the arm had already improved the body warmth had decrease I was not tired and the tongue had decreased in size and heaviness. At no time was medications ingest other than propranolol which I must take daily under doctor's order.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Propranolol 10MG,no,hihg blood presure,Vaccination are reddish and pain in the left arm,"aspirin, penicillin","['Feeling hot', 'Injection site erythema', 'Injection site mass', 'Mastication disorder', 'Nasopharyngitis', 'Pain in extremity', 'Paraesthesia oral', 'Pruritus', 'Swollen tongue', 'Trismus']",2,PFIZER\BIONTECH,IM 933375,OH,30.0,F,"Patient reports the following adverse reactions: hives, tingling, lump in throat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,not on file,,,,none known,"['Paraesthesia', 'Sensation of foreign body', 'Urticaria']",1,MODERNA,IM 933376,GA,27.0,F,"Nausea, fatigue, left arm pain that sometimes shoots up my shoulder",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/11/2021,1.0,PVT,Methylphenidate MIC B12 infusion,None,Narcolepsy,,Sulfa Amoxicillin Penicillin Latex,"['Arthralgia', 'Fatigue', 'Nausea', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 933378,NY,34.0,F,Moder a COVID-19 vaccine EUA Develop Hives 5 hours after immunization,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,None,None,Intermittent asthma,,None,['Urticaria'],1,MODERNA,IM 933379,CT,63.0,F,"Extreme fatigue/weakness body aches, especially hips",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,OTH,,none,connective tissue and muscle problems,,no,"['Asthenia', 'Fatigue', 'Pain']",2,PFIZER\BIONTECH,IM 933380,NY,54.0,F,Subjective fevers Chills Myalgias Lack of Appetite Malaise,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Losartan Metformin Albuterol,,"asthma, DM, HTN",,NKA,"['Chills', 'Decreased appetite', 'Malaise', 'Myalgia', 'Pyrexia', 'Respiratory viral panel', 'SARS-CoV-2 test']",1,MODERNA,IM 933381,,25.0,F,01/08/2021 PT REPORTS FACIAL/NECK/TORSO RASH POST RECEIVING PFIZER COVID 19 VACCINE. ROUTE RN ADMINISTERED BENEDRYL 50 MG IM. RASH STOPPED AND BEGAN TO CLEAR. PT ADVISED TO SEEK MEDICAL ATTENTION IF ANY OTHER AE OCCURED AFTER LEAVING SITE. PT VERIFIED UNDERSTANDING.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,['Rash'],1,PFIZER\BIONTECH,IM 933382,IN,44.0,F,Fever 100.4/body aches/headache 24 hours-ibuprofen x 2 doses,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,Lexapro 10mg,,,,sulfa,"['Headache', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 933383,LA,21.0,F,It was a day after holiday I was feeling very tired and coughing all day. I went to get tested and came back positive for COVID-19.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/26/2020,5.0,WRK,I was taking Tylenol at the time. Also I take Anadrol,None,None,,None,"['COVID-19', 'Cough', 'Fatigue']",1,PFIZER\BIONTECH,IM 933384,NJ,45.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA Onset of chills x 7 hours, significant injection site pain 8/10, injection site swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/10/2021,0.0,WRK,cetirizine qvar inhaler fluticasone nasal spray,,asthma,,penicillin,"['Chills', 'Injection site pain', 'Injection site swelling']",2,PFIZER\BIONTECH,IM 933385,CT,22.0,F,"Less than 24 hours after receiving the vaccine (Jan 7), I started experiencing bad stomach pain, which a family friend had also experienced after she received the vaccine (also ~24 hours later). It did not subside with time, and became feeling like a shooting pain that was coming and going in waves, and I could not sleep that night. I was nauseous at one point, and threw up. I drank water throughout the night, which seemed to help a little bit and was taking an NSAID. The following day (Jan 8), the shooting pain continued, and I was in bed all day. I became nauseous at one point during the day, when attempting to move a piece of furniture, but did not throw up. I continued taking NSAIDs, which did not help. I was able to sleep through the night after taking melatonin, but was in discomfort. The following day (Jan 9), I woke up, and the shooting stomach pain had radiated to my chest, and had not subsided. I called my PCP, who I was unable to see due to timing/distance from the office, and she recommended I go to an ED if I did not feel better. As the pain was in my chest, and I wasn't sure if it had radiated there or was cardiac related, I had a friend drive me to the ED. My results came back normal at the ED, and the PA was only able to tell me that it was GI related, due to the pain in my stomach/esophagus. She was unsure if it's GERD, gas trapped, or some other GI issue. I am still experiencing this pain (Jan 11), but have somewhat managed it by taking Tums and eating alkaline foods.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,SCH,Oral contraceptive & Lexapro,,,,,"['Abdominal pain upper', 'Blood test normal', 'Chest X-ray normal', 'Chest pain', 'Differential white blood cell count', 'Discomfort', 'Electrocardiogram', 'Full blood count', 'Lipase', 'Liver function test', 'Metabolic function test', 'Nausea', 'Oesophageal pain', 'Pain', 'Pregnancy test urine negative', 'Sleep disorder', 'Vomiting']",1,MODERNA,SYR 933386,VA,30.0,F,"The day after I received the vaccination, I developed some mild swelling with a large area of redness around the injection site. My arm was sore for the first 2-3 days following the injection. The swelling went down and the large red patch went away after about 4 days. I had no symptoms from days 5-7. Then on day 8, the red area re-appeared around the injection site, and was very itchy. It also appeared welted. The redness remained from day 8-12. Today is day 13, and the redness seems to have fully resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,Pre-Natal Vitamin,,,,Penicillin,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria']",1,MODERNA,IM 933387,NY,44.0,F,Patient stated 15 minutes post vaccination she felt tingling bilaterally in her feet. She rested for additional 5 minutes and tingling resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,,,,,No Known Allergies,['Paraesthesia'],1,MODERNA,IM 933388,IN,36.0,F,"Around 1am Saturday morning, I began with a 101.7 fever, muscle aches, joint pain, headache, and chills that lasted 36 hours. For the next 12 hours after fever subsided, I was fatigued.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,mild sinus congestion,,,PCN,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 933389,CA,52.0,F,"I woke up at 0500 the day following vaccine administration with moderate to severe intestinal cramping. I have never had this feeling. This persisted at that level for the day. It continued albeit milder, for the next 36 hours. It is now Monday morning and I still have stomach pain. It is not accompanied by any nausea or diarrhea. I do feel some mild constipation and bloating. None of this is typical for me. I have had no changes in eating that I can correlate. No one else in my family has been ill.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Venlafaxine 75mg,none,none,,"Penicillin, Keflex, eggplant","['Abdominal distension', 'Abdominal pain upper', 'Constipation', 'Gastrointestinal pain']",2,PFIZER\BIONTECH,IM 933390,TN,31.0,F,Lip swelling with history of cosmetic lip fillers,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,WRK,Spirinolactone 150mg qday Citalopram 20mg qday,None,None,,None,['Lip swelling'],2,PFIZER\BIONTECH,IM 933392,FL,55.0,F,"Got the vaccine on Friday and 14 hours later , early Saturday morning, I started feeling sick. It started with severe chills, and graduated into fever, lethargy, nausea, hyperventilating, headache, and chills interchanging with sweating. I had a fever the entire weekend and it wouldn't go away, even with taking Advil and Tylenol. My oxygen level was fine, but my pulse was elevated. I felt the same as when I had Covid-19 in June, to the point where I thought I had it again, so I quarantined myself, and was going to get tested on Monday. On Sunday afternoon, I started to feel better and thought it was the end of it, but then Sunday night I started shivering again, and it all started again. I took an Ambien to get some good sleep and I woke up at 6am Monday morning feeling better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,OTH,None,None,"None, except that I was Covid -19 positive in June 2020",,None,"['Chills', 'Headache', 'Hyperhidrosis', 'Hyperventilation', 'Lethargy', 'Malaise', 'Nausea']",1,MODERNA,IM 933393,MD,29.0,M,"Moderna COVID-19 Vaccine EUA. Chills, fever (100.4 F), headache. Symptoms were treated with ibuprofen and sleep. Symptoms subsided the morning after.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,WRK,Men's Daily Multi-Vitamin.,None.,Diagnosed with Asthma as juvenile. No current issues.,,None.,"['Chills', 'Headache', 'Pyrexia']",UNK,MODERNA,SYR 933394,,53.0,M,"Chills , headaches , soreness in arm , body aches , body sweating and joint pain .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Hyperhidrosis', 'Pain', 'Pain in extremity']",1,MODERNA,IM 933395,VA,64.0,F,"30DEC20 patient c/o headaches, then on the next day patient c/o hives, lymph node swelling under the arm, malaise (31DEC20) Patient went to ER on 04JAN21 with c/o general fatigue, loss of appetite, nausea, abdominal pain and continuous headaches that worsened.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/01/2020,,PUB,,,,,,"['Abdominal pain', 'Decreased appetite', 'Fatigue', 'Headache', 'Lymphadenopathy', 'Malaise', 'Nausea', 'Urticaria']",1,MODERNA,ID 933396,NY,23.0,F,"Starting around 8 pm on 1/6 I developed a headache and body aches. I took Tylenol which seemed to help my symptoms. At 2:30 AM (1/7) I was awoken with shivering chills, likely a fever. Fever was not confirmed until 8 AM (1/7) when my temperature was taken - 101.3F. I alternated Advil and Tylenol with minimal improvement. At 2 PM (1/7) my temperature was still elevated at 100.8 F. Overall I was very fatigued and had a pounding headache in addition to chills. My fever broke around 7 PM (1/7), at which point my headache and chills were improving. By the next morning, my symptoms were mostly resolved, except for a mild headache which persisted throughout the day (1/8) but resolved by evening time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,None,None,None,,Penicillin (rash),"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 933397,NY,58.0,F,"Rash arms, thighs, lower back",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/09/2021,3.0,WRK,Allegra,no,GERD,,No,['Rash'],UNK,PFIZER\BIONTECH, 933398,NY,48.0,F,"Patient stated she felt ""hot"" post vaccination and her face was remarkedly flushed. Improved with rest and hydration",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,,,,,No Known allergies,"['Feeling hot', 'Flushing']",1,MODERNA,IM 933399,TX,26.0,F,Where I got the shot is still red and itchy. This has been there since I received the injection. I am unsure if it?s from the vaccine or a reaction to the band aid.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,SYR 933400,SC,46.0,F,"About 6 hrs after receiving the Pfizer-BioTech COVID-19 Vaccine my left arm was sore and my left leg, from the knee down was very achy, along with some swelling behind my knee. The next morning my leg did not ache but was very tender to touch, swollen and as of today (3 days later) it is still tender and swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,Adderall Otezla,none,Psoriasis,,Nitrile gloves,"['Arthralgia', 'Joint swelling', 'Pain in extremity', 'Tenderness']",1,PFIZER\BIONTECH,SYR 933401,CT,48.0,F,"Body ache, headache and nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Headache', 'Nausea', 'Pain']",UNK,PFIZER\BIONTECH, 933402,GA,35.0,M,had myalgias and malaise on post-vaccination day 1. Had significant erythema and swelling at injection site and lymphadenopathy on post-vaccination day 6.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/05/2021,6.0,PUB,none,asthma,asthma,,none,"['Injection site erythema', 'Injection site swelling', 'Lymphadenopathy', 'Malaise', 'Myalgia']",1,MODERNA,IM 933403,AR,41.0,F,"Pfizer BioNTech Covid 19 vaccine EUA- Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-- fever 101.3, body aches, chills, extreme fatigue, sore throat, dizziness, sinus congestion , abdominal pain, tender lymph nodes in neck HA and pain at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,multi-vitamin,none,none,,none,"['Abdominal pain', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Lymph node pain', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'SARS-CoV-2 antibody test negative', 'SARS-CoV-2 test negative', 'Sinus congestion']",2,PFIZER\BIONTECH,IM 933404,CT,50.0,F,lymphadenoma,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,WRK,"Lipitor, Norvasc, aspirin, vitamin B12, Vitamin D3, folic acid",none,"hypertension, hyperlipidemia, asthma, sleep apnea,",lymphadenoma,None,['Lymphadenopathy'],2,PFIZER\BIONTECH,IM 933405,IN,44.0,F,Both times I received the injection about 48 hours later I had a headache all over my head and nausea. Today I was so nauseous that I vomited about 4 times. I also noticed strangely that my birthmark on my leg which is normally a light pink had turned a very dark purple.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/10/2021,2.0,PVT,Ibuprofen Biotin Keratin Doterra vitality supplement,None,None,,None,"['Headache', 'Nausea', 'Skin discolouration', 'Vomiting']",2,PFIZER\BIONTECH, 933406,OH,39.0,F,"Developed tingling and red area at the site o injection one week after injection, feels sore and raised",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/10/2021,8.0,OTH,"Tylenol, Valtrex (Did not take the day of the vaccine or days before the vaccine)",none,Chronic pain and cold sores,,none,"['Injection site erythema', 'Injection site pain', 'Injection site paraesthesia', 'Injection site swelling']",1,MODERNA,IM 933407,MO,31.0,F,bleeding for right sclera,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,"Adderall xr, baclofen",,"asthma, ADHD, muscle spasms",,NKDA,['Scleral haemorrhage'],1,PFIZER\BIONTECH,IM 933409,VA,33.0,F,"I received second covid vaccine on 11/8/21 at 7:45am. That night around 7:30pm I started experiencing body aches and chills. The morning of 1/9/21 I developed a fever, head ache and noticed a red, tender area the size of a penny at the injection site. During the weekend the area around the injection site continued to grow. 1/11/21 I noticed the area is itchy, red, tender/tight feeling, and warm. Pain only when the area is touch. This area is 3.5inchs W by 3 inchs L.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/11/2021,3.0,PVT,"Metformin, Vit C",none,PCOS,"MMR had a red, itchy, hot area around injection site that lasted a week- 29 years old.",Cane and latix,"['Chills', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933410,NE,54.0,F,"HAD A N ITCHY RAISED RASH ON MY BODY (EVERYWHERE BUT MY FACE) TOOK ORAL BENADRYL 50 MG THE FIRST EVENING. WHEN I AWOKE THE RASH WAS STILL PRESENT TOOK TWO MORE DOSES OF ORAL BENADRYL 50 MG ALONG WITH A CORTISONE SPRAY FOR THE ITCHING, THROUGHOUT THE DAY. THE RASH WAS GONE BY SATURDAY 1/9/2021 LATE EVENING. DID NOT CONSULT OR GO TO THE DOCTOR",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,NONE,NONE,NONE,,NOPNE,"['Rash', 'Rash papular', 'Rash pruritic']",UNK,MODERNA,SYR 933412,IN,51.0,F,"I woke up the next morning at 6am and my entire body hurt. The pain increased throughout the day to the point that it hurt to move. The pains started to subside around 3pm. When I woke up the 2nd day after the test I was back to normal. I will point out that my sleep, eating, and meds had been off schedule as I was working nights the week before and had just gone back to days. I went to bed at 3:30pm on 1/7/21 and slept until 6am on 1/8/21. So those may have been contributing factors.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,"Citalopram 10mg, Restful legs, Omeprazole, GasX, Aleve, Cranberry Supplement, Garcinia Cambogia, Loperamide HCI Tablets, Bio Freeze, Multivitamin","Bi-polar, asthma","Bi-polar, asthma",,"tree nuts, coconut",['Pain'],UNK,MODERNA,UN 933414,NY,56.0,F,"As of 1/9/2021 upon waking, experienced low grade fever 100.1, and diarrhea, which has continued to this day upon waking at 7am on 1/11/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,PVT,None,None,None,,None,"['Diarrhoea', 'Pyrexia']",1,MODERNA,IM 933415,GA,64.0,F,"Felt fine the first 24 hours other than the arm soreness, moderate pain at site of injection. After 24 hours, my right eye lid started to catch when I started to blink. I call it lid lag. It has persisted longer than 24 hours. My eye lid does not blink the same as my left eye. It's like a brief before it returns to my regular eye lid. There has been no worsening, and no improvement, it has remained the same.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,drops for glaucoma,No,No,,sulfer drugs,"['Eyelid function disorder', 'Injection site pain', 'Lid lag', 'Pain in extremity']",UNK,MODERNA, 933416,FL,83.0,M,"Nausea,severe dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/11/2021,1.0,PVT,"Pepcid,atorvastatin , finesteride, olmesartan, escitalopram, amlodipine",None,None,,"Iodine, shellfish","['Dizziness', 'Nausea']",1,MODERNA,IM 933417,FL,48.0,M,"AE - severe vertigo. The effect came on suddenly (7pm) and the room started spinning. I closed my eyes and lied back on the couch. I could not open my eye (room stopped spinning) until 3am the next morning. I could not stand without losing my balance until 12 noon. Treatment - I took meclizine 25mg at 12 midnight, 2am and 7am. Outcome - vertigo stopped around 3am, equilibrium returned at 12 noon and i was able to stand and walk slowly at that time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,once a day Mutivitamin,none,none,,none,"['Balance disorder', 'Dysstasia', 'Vertigo']",1,MODERNA,IM 933419,AR,56.0,F,"Pfizer Bio NTech COVID 19 vaccine EUA- symptoms began 01/06/21 chills, fever, HA, body aches, N&V",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,"HCTZ, Vit C, D3 and Zimc",none,none,,none,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test', 'SARS-CoV-2 test negative', 'Vomiting']",2,PFIZER\BIONTECH,IM 933421,IN,42.0,F,"Body aches, 800mgs of Ibuprofen every 6hrs, lasted approx 2 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Synthroid Mydayis Valcyclovir Viibryd Furosemide D3 B12 B1 Calcium Citrate Multi vitamin fiber probiotic Magnesium Biotin stool softener,None,None,,None,['Pain'],1,MODERNA,IM 933422,MI,34.0,F,"Patient had no issues with the first injection. States she felt like her face was burning, she was having trouble breathing, and felt light headed. Denies any prior anaphylactic reactions, denies vagal experiences after blood draws. Symptoms started within 5 minutes of the vaccination. Vistaril given, patient monitored for one hour in the emergency department with no further incident and returned to work,.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"lexapro, remeron, klonopin, focalin, ambien",none,"anxiety, depression, broken pelvis",,"azithromycin, lortab","['Burning sensation', 'Dizziness', 'Dyspnoea']",2,PFIZER\BIONTECH,IM 933423,PA,26.0,M,"Sore Left Arm, slight muscle aches and lightheadedness that lasted 24 hours after the day the vaccine was given.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Dizziness', 'Myalgia', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 933424,FL,69.0,M,Soreness around injection site. It is more severe on 3rd day (today) than day after injection. Did not notice any soreness day of or next day until the early evening.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,"MetFORMIN 1,000 mg tablet Commonly known as: GLUCOPHAGE Take 1 tablet by mouth twice daily. TOUJEO SOLOSTAR U-300 INSULIN 300 unit/mL (1.5 mL) Commonly known as: HumaLOG KwikPen Insulin Inject 20-40 units subcutaneously daily at bedtime.",Aproximately December 10 went to emergency room with extreme pain diagnosed as kidney stone. Given pain pills and antibiotics . and Flo-max which I only took for about a week and never again.,Diabetes Low back pain,,None,['Injection site pain'],1,MODERNA,IM 933426,CT,57.0,F,"Same exact signs and symptoms as Covid disease in April 2020. Fever, extreme headache, muscle pain, chills, joint pain, extreme fatigue, weakness, GI symptoms, muscle cramps,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,SEN,"Olmesartan , Hydrochlorothiazide, Women?s 50+ Multivitamin, Glucosamine + Chondroitin, Tumeric Curcumin C3 , Breo Ellipta",None,"Htn, Asthma",,Flagyl,"['Arthralgia', 'Chills', 'Fatigue', 'Gastrointestinal disorder', 'Headache', 'Muscle spasms', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 933427,NC,60.0,F,"Came to Emergency Department on 1/8/2021 and was assessed at 5:21 pm. Symptoms of hives, and upper lip swelling. Complaint of fever, nausea and headache. No airway issues. No shortness of breath. Mild hives improved with diphenhydramine. Patient self treated with diphenhydramine at 3:00 pm on 1/8/2021. No fever found on assessment. Medications given: diphenhydramine, decadron and pepcid. Discharged from facility at 7:30 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,Hypertension,,"Lisinopril, Bactrim, Levaquin, Penicillin","['Headache', 'Lip swelling', 'Nausea', 'Pyrexia', 'Urticaria']",1,MODERNA,IM 933430,PA,35.0,F,"hot, red skin at site of injection, lump beneath skin at injection site, itching at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/10/2021,10.0,PVT,"prozac, prilosec, fish oil, glucosomine & condroitin, b 12, b complex, flinstones chewables, biotin, vit d plus calcium, (all once daily) vistiril (as needed for anxiety)",,"anxiety, depression",,"celexa, raw mangos","['Injection site erythema', 'Injection site mass', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 933432,FL,40.0,F,"The person administering the vaccine did not go deep enough into the muscle and the vaccine accumulated in the subcutaneous fat layer. I had a hard, red, hot spot under the skin that night and continued to spread out very slowly over the next day being hot to touch and very red. I massaged the area with my hand for the next two days and the hard spot where the vaccine was got a little softer but is still there. I haven't had any other reactions except the redness and hot to touch. I'm concerned that since the vaccine was not administered correctly that I will not get the full immunity expected by the second dose. I do have pictures I took of my arm if needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Lexapro, Wellbutrin, Mirena IUD",None,None,"MMR at age 25, fever and rash all over body",None,"['Injection site erythema', 'Injection site induration', 'Injection site warmth']",2,PFIZER\BIONTECH,IM 933433,OH,16.0,M,Vaccine was given to a 16 year old. Patient was monitored for 15 mins post vaccination. Patient showed no signs/symptoms of a reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PUB,unknown,,,,No known allergies,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 933434,WI,50.0,F,"RECEIVED VACCINE IN LEFT ARM, IM, AT 0520, FRIDAY, 1/8/2021. LEFT SHOULDER JOINT PAIN BEGAN SAME DAY AT 12:00 PM (NOON.) SATURDAY, 1/9/2021, CONTINUED L SHOULDER JOINT PAIN AND AT 12:00 NOON, ONSET OF CHILLS AND FATIGUE BEGAN. SUNDAY, 1/10/2021 ONLY LEFT SHOULDER PAIN CONTINUED. MONDAY, 1/11/2021 LEFT SHOULDER PAIN CONTINUES.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,NONE,NONE,NONE,,SHELL FISH,"['Chills', 'Fatigue', 'Injection site joint pain']",1,MODERNA,IM 933435,NJ,64.0,F,"Lump at injection site, pain with touch and redness; 1 week later - Lump at injection site with 2in x 2in round with warmness and redness. Has begun to fade since yesterday 01/10/21; lump is not there anymore",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PHM,,,,,,"['Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 933436,OH,60.0,M,01/9/2021 sweats/fever like I had Covid 19 again. on01/10/2021 sore and swollen under right armpit and swollen neck.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,,Had Covid-19 12/08/2020,none,,,"['Axillary pain', 'Hyperhidrosis', 'Oedema peripheral', 'Pyrexia', 'Swelling']",1,MODERNA,SYR 933438,FL,23.0,M,"Near-fainting, Lightheaded, chest tightness cold sweat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,NONE,NONE,NONE,,NKDA,"['Chest X-ray', 'Chest discomfort', 'Cold sweat', 'Differential white blood cell count', 'Dizziness', 'Electrocardiogram', 'Full blood count', 'Metabolic function test', 'Presyncope', 'Troponin']",1,MODERNA,IM 933439,TX,54.0,F,Within minutes I became flush and very hot. My heart starting racing. I had blood pressure check and heart rate.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,WRK,"I take sentoids ,fenofibrate, and amoxicillin",None,I have migraine issue and hyperthyroidism,,None,"['Hot flush', 'Palpitations']",1,PFIZER\BIONTECH,SYR 933441,CT,40.0,F,"Skin rashes (itchy) and breathing shallow and arm sore. I got prednisone, benadryl, tylenol, clotimazole/hydrocortisone cream, albuterol breathing treatments. Getting better after day 3.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Tylenol, prednisone, benadryl, hydrocortisone cream, medroxyprogesterone injection, escitalopram, clotrimazole betamethasone cream, lidocaine, montelukast, albuterol for nebulizer treatments, olmesartan amlopine, epinastine eye drops, alpra","Asthma, depression, high blood pressure, obesity","Asthma, depression, high blood pressure, obesity",,Penicillin: breathing and throat closes up Nuts: rashes/hives,"['Hypopnoea', 'Pain in extremity', 'Rash', 'Rash pruritic']",1,MODERNA,IM 933443,MD,36.0,F,Vaccine administered out of recommended time frame. Administration occurred 14 days after 1st dose,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,WRK,,,,,,['Inappropriate schedule of product administration'],2,PFIZER\BIONTECH,IM 933445,GA,32.0,F,"Swelling with localized fever, itching and quarter-silver dollar sized lump under skin after initial swelling and lump at injection site had subsided",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/06/2021,9.0,PVT,Lexapro 10mg,,"depression, overweight",,,"['Injection site mass', 'Pruritus', 'Pyrexia', 'Swelling']",1,PFIZER\BIONTECH,IM 933447,AR,21.0,F,"Pfizer BioNTech COVID 19 Vaccine EUA Afternoon 1/6/21 temp was 101.6 mild HA feeling flushed and hot, 1/7/21 temp 99.4 moderate HA, chills and muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,none,none,none,,none,"['Body temperature increased', 'Chills', 'Feeling hot', 'Flushing', 'Headache', 'Myalgia', 'SARS-CoV-2 antibody test negative', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 933449,PA,31.0,F,Redness at the injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/08/2021,10.0,PVT,,,,,,['Injection site erythema'],1,MODERNA,IM 933450,,56.0,F,"fever, body aches, chills, and red halo around injection site. Had vaccine on 01/07 and adverse symptoms began on 01/09 have continued through 01/11 but have gotten better.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/09/2021,2.0,PVT,,,,,,"['Chills', 'Injection site erythema', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 933451,IN,46.0,F,Rash and headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Lisinopril, vitamin D, Wellbutrin, synthroid, aspirin, multi-vitamin",None,Graves Disease,Flu vaccine 2020,"Sulfur, PCN, Levaquin, Dilaudid.","['Headache', 'Rash']",UNK,PFIZER\BIONTECH, 933452,AZ,60.0,F,"Slight headache, light headed and then slight dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"vitamin D 500 mg and multi vitamin (hair, nails and skin)",none,none,,Sulfa,"['Dizziness', 'Headache']",1,MODERNA,IM 933453,KY,59.0,F,"Received vaccine at 08:15 and by 08:25 I had a red rash on bilateral arms. My throat and tongue felt as if it was starting to swell. I was given Benadryl 25mg by mouth and escorted to the ER by administration. While in the ER I was given anther Benadryl 25mg, Prednisone 40mg by mouth and epinephrine 0.3 mg injection. After about an hour I was discharged home with a prescription of prednisone 20mg to take for 10 days. I have been taking the prednisone and Benadryl 25-50 mg every 8 hours since the reaction occurred. I still have a rash on my body today and some red dots on body today also.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Lisinopril 10mg once a day,"I was treated for Strep throat on December 14,2020",Hypertension,Quad flu vaccine in 2017,"Sulfa drugs, cefdinir,hydrocodone,quad flu vaccine,peppermintStrep","['Pharyngeal swelling', 'Rash', 'Rash erythematous', 'Swollen tongue']",UNK,MODERNA,IM 933455,NJ,56.0,F,"The day after the employee received her 2nd COVID vaccine, she woke up with swollen, itchy eyelids. She had a telehealth visit with doctor on 1/10/21 - she reported that the itchiness and swelling were along her upper eyelid near the brow line. Denied ocular pain, EOMI, conjunctive is not infected. Noted slight particles in the corners of her eye but it was not crusting. Had used hydrocortisone cream on the area but was advised by doctor to stop. Dr encouraged cold compresses, increased fluid intake and avoid salt/caffeine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,,,,,"Latex, Shellfish, Sulfa","['Eye pruritus', 'Swelling of eyelid']",2,PFIZER\BIONTECH,IM 933456,NC,48.0,M,"Within 10 minutes felt a rush of heat down right arm and tingling in fingers. Then I felt it in the left arm, however the left arm stopped tingling within 24 hours, but my right arm still has the tingling , feels bloated in my hand and my arm feels restless.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,None,None,No,,None,"['Feeling hot', 'Paraesthesia', 'Peripheral swelling', 'Restless arm syndrome']",1,PFIZER\BIONTECH,SYR 933457,FL,26.0,F,"4 hours after administration (1/8/21) I had nausea. The following day (1/9/21) I had a mild fever, body aches, headache, and was fatigued. These symptoms lasted until about 7pm until I took Tylenol. Once I took Tylenol I felt almost immediately better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Multi Collagen Pills and Friska women's daily,None,None,,None,"['Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 933458,FL,59.0,F,"Fever, Chills, extreme head ache and severe body aches, weakness, all lasting 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Levothyroxine, multi vitamin, iron, red yeast rice, fish oilbiotin","COIVD-19 positive test on12/29/2020, very mild case, slight fever one day with mild head ache and body aches 24 hours.",None,,None,"['Asthenia', 'Chills', 'Condition aggravated', 'Headache', 'Pain', 'Pyrexia']",UNK,MODERNA, 933460,KY,26.0,F,Fatigue for greater than 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,"Seasonique, escitalopram, cetirizine",None,Anxiety/depression,,None,['Fatigue'],UNK,MODERNA,IM 933461,FL,45.0,F,"chill, Dizzied, headache , vertigo, Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/11/2021,5.0,WRK,,,BP/ Asthma,Flue,Theraflu,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Vertigo']",1,MODERNA,IM 933464,PA,43.0,F,"Low grade fever (99.4); nausea, body aches, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/07/2021,2.0,PVT,,,,,,"['Chills', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 933465,PA,43.0,F,"Severe pain in shoulder/arm, motor deficit. Treated with Tylenol and Advil and ice, pain persisted approx. 48 hours. Motor deficit improved, but still present",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/04/2021,13.0,PVT,fish oil CLA Loratidine Flonase,none,none,,nkda,"['Arthralgia', 'Mobility decreased', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 933466,PA,48.0,F,"Moderna COVID-19 Vaccine EUA (directed to type this on this line) Severe dizziness started at 11:00-45 minutes after time of injection. Continued until 5:00pm same day; however mild dizziness continues still ( 1/11 @ 9:00am). Starting 1/9 @ 5:00 flu -like symptoms started (nausea and vomiting, shakes, weakness) continued until 1/10 am, then lingering light dizziness and weakeness. As of 1/11 only lingering light dizziness remains.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,,none,none,,"PCN, erythromycin","['Asthenia', 'Dizziness', 'Influenza like illness', 'Nausea', 'Tremor', 'Vomiting']",1,MODERNA,IM 933467,VA,61.0,F,"Headache , Fever 102, Nausea, Faint, Body/Muscle aches (lasted for 2 days)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PUB,Atorvastatin 10mg Co-Q 10 Famotidine Calcium Aspirin 81mg,None,Covid-19 (July) Ischemic Heart Disease Vitamin B-12 Deficiency Vitamin D Deficiency Osteoporosis,,Cardizem,"['Headache', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Syncope']",UNK,MODERNA, 933469,AR,34.0,M,"Pfizer BioNTech COVID 19 Vaccine EUA- All at once became flush, hot , dizzy & nausea, abdominal pain & extreme dizziness. Went directly to MD who said it was a fairly normal side effects post COVID vaccine. Instructed to take Zofran APAP and if symptoms became worse to take Benadryl and my epi pen and seek emergency Tx. AT home N&V and abd. pain continued with extreme fatigue and chills. Continued the following day but mild. 1/7/21 symptoms relieved. Body & head feels fuzzy but no illness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,"Iron, Vit C , Multi Vitamin",none,none,,Wasp/Bee sting,"['Abdominal pain', 'Chills', 'Dizziness', 'Dizziness postural', 'Fatigue', 'Feeling abnormal', 'Hot flush', 'Nausea']",2,PFIZER\BIONTECH,IM 933471,NY,53.0,F,"Woke at 3 am with severe myalgias, tachycardia, nausea and shortness of breath. Went to get tylenol/ zofran but felt like I was going to vomit. Went into the bathroom and sat down. Woke up on the floor shaking. Not sure how long I was down. According to my watch my HR was around 110+ for a hour and a half (3-4:30 am)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,synthroid,hashimoto thyroiditis bechets disease gilberts,same as question 11,,pcn,"['Dyspnoea', 'Malaise', 'Myalgia', 'Nausea', 'Tachycardia', 'Tremor']",2,PFIZER\BIONTECH,IM 933472,,22.0,F,"Redness at injection site - warm, itchy, swollen Red patch got bigger over 24 hours Took Benadryl prior to doc appt Doctor prescribed benadryl around the clock and keflex",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/04/2021,7.0,UNK,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 933473,NY,45.0,F,"Fever, Nausea, Muscle and Joint pain, Fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Lisinopril; Fiber; B12,No illness,Blood pressure,,No known allergies,"['Arthralgia', 'Fatigue', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,SYR 933474,WY,80.0,M,"Feeling unwell, chills, achy legs, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/10/2021,3.0,OTH,"Tamsulosin hydrochloride, clonidine, lisinopril, Preser vision",None,Parkinson?s,,Pistachio nuts,"['Chills', 'Malaise', 'Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 933476,IL,42.0,F,"A little over 24 hours post vaccination (09JAN2021), I started to experience some tongue numbness/tingling along the lateral edges and the tip of my tongue. This is ongoing as of time of this report. This is not interfering with function, but it is a new symptom that I did not have prior to receiving my vaccination. As additional medical history in the last 30 days, I had dental work done for a broken filling on 21DEC2020 (multiple numbing injections during this visit - two molars grounded down to prepare for placement of two crowns of left lower molars). 2 crowns placed on 06JAN2021 (1 numbing injection at this visit). Additionally, I also started with symptoms of inner ear infection on 03JAN2021, was evaluated by medical provider on 05JAN2021 and diagnosed with suspected inner ear infection, for which I am currently taking doxycycline and sudafed for.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Doxycycline Monohydrate 100 mg BID (started taking on 06JAN2021) Sudafed (Pseudoephedrine HCl) 60 mg Q6H (started taking on 04JAN2021),"Major dental work completed in month prior to vaccination. 21DEC2020 - started process of 2 crowns on left lower molars (ground teeth down, placed temporary crowns), and placed permanent crowns on 06JAN2021. Also, started having symptoms of inner ear infection (right ear) on 03JAN2021, started sudafed on 04JAN2021, then prescribed and started taking Doxycycline on 06JAN2021.",Occasional headaches Painful menstrual cycles,,None,"['Hypoaesthesia oral', 'Paraesthesia oral']",1,MODERNA,IM 933477,FL,40.0,F,"very sore for 3 days, itchy for like 3 days, hives surounded it like 8 hours after the vacccine and I still have some of them around the site. I took my medications that I have to help with this on a normal basis. It took 3 plous days to get it to stop.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,WRK,"Abilify amitriptyline clonazepam Depakote doxepin gabapentin hydrocodone-acetaminophen hydroxyzine HCl ibuprofen lidocaine Linzess omeprazole oxybutynin chloride sumatriptan succinate valsartan-hydrochlorothiazide Xolair, one a day women's",none,"Allergies, ASinus issues, and chronic back pain",,"wheat, eggs, milk, tomatoes, corn, peanuts,. almonds all grass, except Bahimian Hickory and Pecan Trees","['Injection site pain', 'Injection site pruritus', 'Injection site urticaria']",1,MODERNA,IM 933478,FL,32.0,M,"The morning after receiving the vaccine, I began to develop a fever, chills and fatigue, along with soreness at the injection site. I had taken my temperature throughout the day with a Tmax of 101 F, which broke ~36 hours after receiving the vaccine. No additional symptoms were experienced (diarrhea, nausea, vomiting, etc.)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,UNK,,,,,,"['Chills', 'Fatigue', 'Injection site pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933479,MT,47.0,M,"99.9 temp, chills, achy, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/09/2021,2.0,PVT,,,,,,"['Body temperature increased', 'Chills', 'Dizziness', 'Pain']",2,PFIZER\BIONTECH,IM 933480,,39.0,F,"Redness around injection site - warm, raised, dark red, not painful but tender",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/06/2021,8.0,UNK,,,,,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 933482,PA,28.0,F,"Fever, chills, headache, myalgias started around 10 pm worsened through the night. Fatigue the next day and nausea. Headache has persisted still have it currently. Have been hydrating and taking ibuprofen which helps",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,WRK,"Zoloft, buspar, vitamin d",,,Headache,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933483,MS,46.0,F,"Diarrhea beginning within 12 hours of receiving vaccine, treated w/hydration, no food, pepto bismol, rest, no medical needed. Still ongoing >10 days out from vaccine, not as severe as initial onset, but returns as soon as pepto bismol has worn off.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,MIL,"Zoloft, Wellbutrin, Buspar, Lisinopril, Allegra, Singulair, B complex with Vit C, iron, citrucel, magnesium",None,"HTN, Allergies (environmental), Major depression, generalized anxiety disorder, iron deficiency anemia",,"PCN, Sulfa, Ceftin, Celexa: Rash Monurol/Zyrtec: paradoxical-hypotension/vascular collapse, petecchiae, presyncope Erythromycin: vomiting",['Diarrhoea'],1,PFIZER\BIONTECH,IM 933484,FL,40.0,F,"Arm was typically sore after a vaccine, but I am still sore and have now developed a redness area that is moving down my arm and up to my shoulder. Erythema is approximately 5.5 inches in length from top of my shoulder extending towards the medial side of my right arm. Width is approximately 6 inches extending across my arm. The tenderness has also moved with the redness and is now the most tender on the medial side in the middle of my arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,OTH,"Unithroid, Cytomel, Zyzal",None,Hashimoto's disease; seasonal allergies,,NKA,"['Erythema', 'Injection site erythema', 'Pain in extremity', 'Tenderness']",1,MODERNA,IM 933485,LA,52.0,M,"The day following my second vaccination I had body aches, headache and chills that lasted for approximately 3 hours. In addition, on this same day I experienced mild tiredness for most of the day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,Losartan,,Hypertension- Controlled with BP medication.,,Cephalosporins,"['Chills', 'Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 933486,NJ,62.0,F,swelling in left axilla pain in L axilla,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,hctz METOPROLOL ATORVASTATIN ZETIA,NO,HYPERTENSION,,,"['Axillary pain', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 933487,WV,40.0,F,"REPORTS HAVING BURNING AND TINGLING PAIN IN LEFT UPPER LEG FOR ABOUT FIVE DAYS, AFTER THIS A ZOSTER RASH ERUPTED ON MID THIGH AND MEDIAL THIGH. VALTREX 1 GRAM TABLET THREE TIMES A DAY FOR 7 DAYS WRITTEN.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/08/2021,10.0,PVT,"VITAMIN D 10,000 IU PROBIOTIC ON RITUXAN MAITENANCE LAST INFUSION 12/08/2020","NON HODGKINS LYMPHOMA PRIMARY CUTANEOUS MARGINAL ZONE AND NODAL ON RITUXAN MAITENANCE, LAST INFUSION 12/08/2020",NON HODGKINS LYMPHOMA PRIMARY CUTANEIOUS MARGINAL ZONE/NODAL B CELL,"AS A CHILD HAD HIVES AND SHORTNESS OF BREATH AFTER RECEIVING PERTUSSIS VACCINE, PT HISTORIAN",PERTUSSIS VACCINE,"['Burning sensation', 'Paraesthesia', 'Rash', 'Rash vesicular']",1,MODERNA,IM 933488,PA,23.0,M,Extreme arm soreness and swollen lymph nodes in the opposite arm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,,,,,,"['Lymphadenopathy', 'Pain in extremity']",1,MODERNA,IM 933489,,49.0,F,"Body aches, fever, dizziness, nausea Took tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/05/2021,1.0,UNK,,,,,,"['Dizziness', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 933490,NC,34.0,M,Marble sized swollen and hard lymphnode on my Clavicle on the injection side,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/10/2021,2.0,PVT,Levoxthyroxine Wellbutrin Vitamin D,None,Hypothyroidism,,None,['Lymphadenopathy'],2,PFIZER\BIONTECH,IM 933491,IN,48.0,F,"I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt severely and I felt my throat swelling, it became increasingly difficult to swallow. My tongue felt larger and my lips and face began to feel numb. I felt flushed and I became tachycardic. It lasted about 45 seconds and then waned and then would flare again. I was able to speak and called my husband (a physician) who stayed on the phone with me while I drove to the hospital. I went straight to an outpatient unit and was given hydrocortisone IV, loratidine PO and famotidine. By the time I was on the unit, my throat only felt slightly tight with tachycardia down to 103. Following the injection of steroids, I only had one further flare of throat tightness and tachycardia that was transient lasting 30-40 seconds. Everything resolved within 40 minutes of receiving therapy. Of note, I apparently had erythema on the anterior of my neck which corresponded to the area of throat tightness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,Migraines,,Penicillin-hives Tetracycline-hives Clindamycin-hives Erythromycin intolerance-severe diarrhea,"['Dysphagia', 'Erythema', 'Flushing', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Injection site pain', 'Pharyngeal swelling', 'Swollen tongue', 'Tachycardia', 'Throat tightness']",2,PFIZER\BIONTECH,IM 933492,IN,55.0,F,"Was fine for a week no issues then starting Jan 9th I have swelling, redness, itching and it is hot to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/09/2021,7.0,PVT,"Levothyroxine 100mg, Lisinopril 5 mg",,,,,"['Erythema', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,IM 933494,MT,32.0,M,"joint pain, 99-100 temp, headache, general unwell feeling",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Arthralgia', 'Body temperature increased', 'Headache', 'Malaise']",2,PFIZER\BIONTECH,IM 933495,,31.0,F,Arm swollen and sore Fever (102.2) and chills,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Chills', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 933496,MN,31.0,F,I felt flushed and light headed after receiving the vaccine but as the day went on I felt worse. By 2030 I had severe full body chills and could not stop shaking. I had a severe headache/migraine. Every muscle in my body hurt. This continued on for the entire night. Got tested for COVID the next morning with the rapid results and the symptoms continued with the muscle aches and severe headache. Vision became blurry and I became very dizzy. Slept for 8 hours during the day on 1/7/2021 and then slept another 12 hours that night. The body aches and headaches continued until 1/8/2021 at which the symptoms finally subsided,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Fluoxetine, Metformin, Phentramine, Prednisone, Omeprazole, Humira, Vit D with Calcium",None,RA,,Sulfa Drugs,"['Chills', 'Dizziness', 'Flushing', 'Headache', 'Migraine', 'Myalgia', 'Pain', 'SARS-CoV-2 test negative', 'Somnolence', 'Tremor', 'Vision blurred']",2,PFIZER\BIONTECH,IM 933497,FL,53.0,F,"Significant swelling of L>>R anterior cervical lymph nodes. No SOB or wheezing, but given acuity and severity of swelling, she was given give epinephrine, benadryl, and solumedrol. She was monitored for 30-40 minutes after treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Lantus, Vitamin B-12 supplement, Zyrtec",None,"Type 2 diabetes, hypertension, hyperlipidemia, HX of DVT (following MVA), morbid obesity, multinodular goiter, OSA",,"Bydureon, Cipro, Iodine, Sulfa, Metformin, Victoza, ACE inhibitors",['Lymphadenopathy'],1,MODERNA,IM 933498,VA,28.0,F,"Immediate arm soreness after injection but otherwise felt fine until about 2130 when over about a 30 minute period onset of fever, myalgias, chills, and nausea. Called off work from my job as a flight nurse at midnight. Tried to sleep it off until about 0430 when the body aches became unbearable. Ate a few bites of yogurt and took 400mg of ibuprofen. No change in symptoms until 0530 when I took a hot shower which helped relieve some muscle pain. Took 400mg ibuprofen again at 1030 with a small snack with no change in pain or fevers. Took hot shower again which helped briefly. Nausea subsided around 1630, enough that I had a small meal of bland food and another 400mg of ibuprofen. By 1700 more tolerable myalgias and fever came down some. 2230 another 400mg dose of ibuprofen, fitful night of sleep waking again at 4am with shooting lower back pain and fever. Took another dose of 400mg ibuprofen and a hot shower. Woke up at 1000am sweaty with mild myalgias and low grade fever. Took another dose of ibuprofen 400mg, 30 minutes later profusely sweaty but afebrile. Fatigued all day and poor appetite until late evening. Woke up next day after better night of sleep at 0730. Mild fatigue and bad heartburn all day and night. Left arm still sore to touch. This morning (1/11) feeling mild heartburn but better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,"Ocella OCP, Strattera 40mg daily, Vitamin D 40,000 IU weekly",None,"ADHD, anxiety, Hashimoto?s thyroiditis (currently euthyroid), migraines",,"Ciprofloxacin, Sulfa, Bactrian, Latex sensitivity","['Back pain', 'Chills', 'Decreased appetite', 'Dyspepsia', 'Fatigue', 'Hyperhidrosis', 'Immediate post-injection reaction', 'Myalgia', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933501,FL,51.0,F,sudden onset intense itching and recurrent( increased when compared to initial reaction) redness and swelling. symptoms have continued; not at day 4 despite taking Benadryl cream; took Motrin one day,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/08/2021,11.0,PVT,occasional zyrtec/melatonin,none,none,,seasonal/mold,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA,IM 933503,NC,36.0,F,"patient reports feeling anxious prior to arrival, she reports ""overthinking"" the vaccine. Has history of vasovagal response with injections, blood draws or blood donations",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,patient reports none,none,none,,patient reports none,['Anxiety'],1,PFIZER\BIONTECH,IM 933504,,54.0,M,Respiratory symptoms Headache Body aches No smell/taste Took Tylenol and mucinex,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/11/2021,14.0,UNK,,,,,,"['Ageusia', 'Anosmia', 'Headache', 'Pain', 'Respiratory symptom', 'SARS-CoV-2 test negative']",1,MODERNA,IM 933505,OH,47.0,F,"Diarrhea, vomiting, fatigue, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,"Protonix, Strattera, Lexapro, advil.",None,None,,None,"['Diarrhoea', 'Dizziness', 'Fatigue', 'Vomiting']",1,MODERNA,IM 933506,IN,38.0,F,"Itching, rash and swelling at the site on right arm - 2 inches by 5 inches in size. The above reaction resolved on Sunday, Jan 10 at 11:00am. ENLARGED LYMPH NODE on the right side of my neck which protrudes enough to see without having to palpate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/09/2021,7.0,PVT,"Multi vit, B6, primrose oil, vit D, iron, fiber",none,none,Flu vaccine in 2017 caused the same enlarged neck lymph node,none,"['Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Lymphadenopathy']",1,MODERNA,SYR 933534,WI,29.0,F,"Friday morning1/8/21 at 0645 when awaking it felt like my right nostril was congested and it was hard to breath, also the tip of my nose was bright red, swollen and tender to touch. throughout the day the swelling, redness and pain increased with the right side of my nose. breathing did get easier. Saturday 1/9/21 the right side of my nose was still presenting with symptoms listed above and continued to grow toward my right eye. Sunday 1/10/21 the swelling increased but redness and pain stayed the same as the previous day. Ice was applied with mild improvement. No medication was taken. Monday 1/11/21 swelling on the right side of the nose has slightly gone down, minimal swelling (puffiness) under the right eye had started.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,"Wellbutrin 450mg, Venlafaxine 150mg",none,none,,"Sulfa, Cephalaxin","['Dyspnoea', 'Erythema', 'Nasal congestion', 'Periorbital swelling', 'Rhinalgia', 'Swelling face', 'Tenderness']",1,MODERNA,IM 933535,CA,44.0,F,"Fatigue, chills, body ache, a little fever, night sweats, felt something heavy on chest, felt like walking on clouds, felt out of place. Symptoms lasted about 1 day & a half.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,UNK,None,Common cold symptoms a few weeks prior to vaccine,Diagnosed with Hashimoto Disease a few years ago,,None,"['Chest discomfort', 'Chills', 'Fatigue', 'Feeling abnormal', 'Night sweats', 'Pain', 'Pyrexia']",1,MODERNA,SYR 933536,MT,22.0,F,"muscle aches, chills, nausea, headache, swollen lymph nodes",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Chills', 'Headache', 'Lymphadenopathy', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,IM 933537,CT,25.0,F,"25 year old PhD student in program presents with arm redness at injection site 8 days after 1st dose Moderna vaccine 12/31/20. No immediate side effects except for pain at injection site. That night was new years and had a couple alcoholic drinks, that night had headache and the next day felt tired. Pain at injection site lasted 48 hours-similar to flu shot HA and fatigue resolved by 2 days later � Woke up this morning at noticed injection site redness and very mild soreness if she touches. Not warm, no blisters/vesices/crusts Minimally itchy only in the last 15 minutes No pain when moving arm No swollen glands in axilla. No other rash or hives anywhere else No facial swelling, dyspnea, wheezing, N/V, diarrhea, lightheadedness, weakness, confusion",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/08/2021,8.0,SCH,,,,,,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,IM 933539,FL,59.0,F,"Severe head ache and body aches, fever and chills, weakness, loss of appetite, lasting 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Levothyroxine, multi vitamin, iron, red yeast rice, fish oilbiotin","COIVD-19 positive test on12/29/2020, very mild case, slight fever one day with mild head ache and body aches 24 hours.",None,,None,"['Asthenia', 'Chills', 'Decreased appetite', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,SYR 933540,IN,31.0,F,Headache 24 hours started 1 hour after vaccine Fatigue 6 hours after vaccine lasted until 1/11 so around 48 hours after vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PUB,None,None,None,,None,"['Fatigue', 'Headache']",UNK,PFIZER\BIONTECH, 933541,NJ,17.0,M,The vaccine is recommended for 18 and older,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/11/2021,4.0,PUB,none,None,None,,KNDA,['Product administered to patient of inappropriate age'],1,MODERNA,IM 933542,IL,50.0,F,"patient with c/o increased HR and scratchy throat, BP 113/78 HR 130 Pulse Ox 95% on RA, patient response called, patient transported to Emergency Department and received Famotidene 20mg IV, Diphenhydramine 50mg IV, Lorazepam 1mg Oral, Ketoralac 15mg IV, one liter normal saline. Observed and discharged home.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Heart rate increased', 'Throat irritation']",2,PFIZER\BIONTECH,IM 933543,TN,50.0,F,"LOSS OF TASTE, REDUCED SENSE OF SMELL",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/10/2021,11.0,PVT,"MICARDIS, CYMBALTA, MVI,TUMERIC",NONE,"HYPERTENSION, MIGRAINE",,"SHEA BUTTER, DARVOCET","['Ageusia', 'Anosmia']",1,MODERNA,IM 933545,MA,62.0,F,"Developed a delayed local skin reaction with redness, itching, thickened red skin and stinging",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,WRK,"Losartan, VItamin D, Rosuvastatin, occasional Gabapentin",none,"HTN, hyperlipidemia, osteoarthritis",,oxycodone,"['Erythema', 'Local reaction', 'Pain', 'Pruritus']",1,MODERNA,IM 933546,IN,32.0,F,"starting 12.5 hours post vaccine - chills, headache, body aches, nausea, rash at injection site, fatigue. Chills and headache resolved after 24 hours. Other symptoms still present 36 hours later. Treated with tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,UNK,,None,,,None,"['Chills', 'Fatigue', 'Headache', 'Injection site rash', 'Nausea', 'Pain']",UNK,PFIZER\BIONTECH, 933547,IN,54.0,F,"Extreme headache and nausea. Headache started on 1/8/21 about 6pm and lasted a couple of hours. Saturday 1/9, just had tenderness to injection site until 1030pm when the headache returned. Hurt to move my head. Woke up on 1/10, extreme headache and nausea. Hurt to move head and was nauseated whenever I bent over.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,"Metformin, Avalide, Allegra, Meloxicam, and Pregabalin taken that morning @ 7am.. also Lantus and Humalog.",,Hypertension and type 2 diabetes,,"Neosporin, toujeo, and prednisone","['Headache', 'Injection site pain', 'Nausea']",2,PFIZER\BIONTECH,SYR 933548,IN,30.0,F,"Arm soreness- mild, 2 days Headache - mil, 20-60 minutes Diarrhea - mild, 1 day Fatigue - mild, .5 day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Birth control,Pityriasis rosea rash 3 weeks prior,None,,None,"['Diarrhoea', 'Fatigue', 'Headache', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 933549,KS,61.0,F,patient developed a warm sensation through arm. We had the patient stay for monitoring for 30 mins following her injection of the moderna COVID19 vaccine. Then the patient developed 3-4 Hives. BEnadryl and Zyrtec was given.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,Benadryl and Zyrtec given,none,none,,NKDA,"['Feeling hot', 'Urticaria']",1,MODERNA,IM 933551,MT,58.0,F,"dizziness, fatigue, vomiting, diarrhea, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/09/2021,2.0,PVT,,,,,,"['Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Vomiting']",2,PFIZER\BIONTECH,IM 933553,KS,42.0,M,"104.2 degree F fever. Abated with time, APAP and Ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,APAP and Ibuprofen for fever. No other medications reported,None reported,None Reported,,NKDA,['Pyrexia'],2,PFIZER\BIONTECH,IM 933554,TX,35.0,F,"Pain and tenderness at injection site following 12 hours post-vaccination. Head fogginess, difficulty focusing on tasks, and light-headedness began around 9:00AM on 1/8/2021, and progressively worsened throughout course of day. Severe body aches and joint pain (entire body) with severe malaise and fatigue began later that evening about 8:00PM on 1/8/2021 until about 12:00PM on 1/9/2021. Took Tylenol 500mg as indicated for 24 hours. Symptoms resolved by mid-afternoon 1/9/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Zoloft, Flexeril, Microgestin, Tylenol",none,Chronic neck pain; IBS; Hyperlipidemia; Anxiety,,Cefdinir,"['Arthralgia', 'Disturbance in attention', 'Dizziness', 'Fatigue', 'Injection site pain', 'Malaise', 'Pain']",2,PFIZER\BIONTECH,SYR 933556,IN,38.0,M,"Headache for the past 3 days Vomiting, 2nd day after getting the shot",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Fluoxetine,,,,None,"['Headache', 'Vomiting']",1,MODERNA,SYR 933557,PR,46.0,F,"Erytema with facial flushing on neck and face, Nauseas, no vomit, No dyspness, no shortness of breath. treatment Benadryl IV = Solumedrol + Famatidine IV",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PUB,Synthroid 5mcg po cada dia,,Hipotiroidismo,,None,"['Erythema', 'Flushing', 'Nausea']",1,PFIZER\BIONTECH,IM 933559,MA,26.0,F,"Severe headache and nausea about 2 hours after first dose, lasted about 24 hours. Improved with Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Sprintec,,,,nkda,"['Headache', 'Nausea']",1,MODERNA,IM 933560,OH,54.0,M,"Tired, sweats, chills, 102.3 temperature, head pressure, ""felt like crap"", sore arm, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,none,,,"['Body temperature increased', 'Chills', 'Fatigue', 'Head discomfort', 'Hyperhidrosis', 'Malaise', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 933561,MI,28.0,F,"fever, chills, headache, extreme body aches, nausea, weakness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,WRK,,,,,,"['Asthenia', 'Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 933562,IN,31.0,F,"I had fevers of 101.5 f, severe body aches, headache, strong chills, sinus pressure. My entire arm that I received the shot in was painful and tingling down to my fingers for 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,UNK,Birth control,None,Polycystic ovarian syndrome,,No,"['Chills', 'Headache', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Paranasal sinus discomfort', 'Pyrexia']",UNK,MODERNA, 933565,IN,27.0,F,"24 hours of low grade fever ranging 99.6 -100.8, chills, body aches, fatigue. Symptoms lasted about 24 hours. Treated with Tylenol and ibuprofen. Fine 48 hours after vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,WRK,"tylenol, ibuprofen, prenatal vitamin, fiber pill, probiotic, zyrtec, flonase",,,,Sulfa,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933566,ME,50.0,F,"histamine response - watery, red, itchy eyes, nasal congestion, runny nose, itchy skin",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,OTH,none,none,migraines,,none,"['Eye pruritus', 'Lacrimation increased', 'Nasal congestion', 'Ocular hyperaemia', 'Pruritus', 'Rhinorrhoea']",1,MODERNA,IM 933567,IN,44.0,F,"Achy, chills, arm pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,"Lamictal, Vit D, Paxil, Zebeta, Losarten, birth control, daily vitamin, pamelor","COVID, migraines","Seizure disorder, migraines",,"Tetracycline, Topamax","['Chills', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 933568,MD,61.0,F,"Patient received the first dose of Moderna COVID vaccine on 1-3-2021. The redness, heat, itchiness, induration at the site of the Moderna COVID vaccine, left deltoid, started on 1/6/2021 and getting worse. The area measures 6 cm X 6 cm. Patient states the redness and induration is getting larger. Patient instructed to apply ice and take Benadryl. The patient was referred to her primary care provider.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/06/2021,3.0,PVT,Unkown,None,Unknown,,"PCN, Latex, Mango, Bacitracin","['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 933570,MT,35.0,F,"tiredness, headache, muscle pain, chills, joint pain, fever, injection site pain, general feeling unwell",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933571,NH,39.0,F,Moderna COVID?19 Vaccine EUA Swollen lymph nodes in armpit on same side as shot was given,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/08/2021,4.0,PVT,"Concerta, Nuvaring",,,,Lactose,['Lymphadenopathy'],1,MODERNA,IM 933572,IN,57.0,F,"Second dose; received on Friday 01. .21. On that evening, I had nasal congestion, which is no big deal. I had some redness, then on the next day, Saturday I started having body aches everywhere, I took two tylenol, and then I was fine. Then when I awoke the next morning, my arm was really sore. The injection site is red and warm and is tender, but not bad bad. The warmth of it is the worst part.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/11/2021,3.0,PVT,"Metformin 1000mg, Jardians 10mg, Celibrex 100mg,",,Arthritis and Diabetic Type 2,,"Penicillin, Demerol","['Erythema', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Nasal congestion', 'Pain']",UNK,PFIZER\BIONTECH, 933573,KS,42.0,M,Fever to 104.2 F. Abated with APAP and Ibuprofen.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,none reported,none reported,none reported,,NKDA,['Pyrexia'],2,PFIZER\BIONTECH,IM 933574,MI,52.0,F,"within 12 hours of receiving the vaccine, both eyelids swelled and her right eye developed puss-filled lesions. Has an appointment with the family physician at 4:40 pm today January 11, 2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PUB,Multivitamin Tumeric Omega-3 Vitamin C B-Complex,none,none,,"Biaxin, PCN, Indomethacin, latex, Bactrim","['Blister', 'Eye pain', 'Swelling of eyelid']",1,PFIZER\BIONTECH,IM 933576,WI,53.0,F,"1/8/21 AM headache over the eye, injection site sore arm; PM body aches, chills and shivering, fever 107., joint pain --over the counter ibuprofen no relief, weakness in legs. 1/9/2021 body aches and fever resolved. Fatigue, weakness and joint pain, Tylenol --some relief. Swollen lymph nodes in left armpit and soreness; low back pain, shooting hip pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Synthroid, Fish oil, Multivitamin, Vitamin D, Estradiol patch",,,"Shingrix (1st dose) 09/30/2020, shivering, coldness, headache","Latex, bananas, Compazine","['Arthralgia', 'Asthenia', 'Back pain', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Muscular weakness', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 933577,MA,55.0,F,"The morning after the shot I woke up with chills, total body aches, headache and extreme fatigue. I broke my wrist last year and the ache in that wrist was awful. Motrin helped but this persisted throughout the day. General feeling of being unwell for the whole day and evening. The second day after the shot I woke up feeling better but in my armpit on the arm I received the shot it felt like I had a lump in my arm pit and it is sore. This is still there today, the third day after the shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,WRK,Vitamin D,None,None,,Metronidazole and Fentanyl,"['Arthralgia', 'Axillary mass', 'Axillary pain', 'Chills', 'Fatigue', 'Headache', 'Malaise', 'Pain']",2,PFIZER\BIONTECH,IM 933578,NY,43.0,M,Pronounced dead 1/9/2021 at 12:42. Received first dose of vaccine 1/8/2021,Yes,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,,,PUB,"metform, atorvastin","Diabetes, Hypertension, Sleep Apnea, Obese",Hx smoking,,NKA,['Death'],1,MODERNA,IM 933579,SC,47.0,F,Persistent headache and malaise with intermittent nausea and muscle/joint aches - began 1/4/21 and ongoing,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,PVT,,None,None,,Sulfa drugs,"['Arthralgia', 'Headache', 'Malaise', 'Myalgia', 'Nausea', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 933582,IN,25.0,F,"Typical injection site/muscle soreness. Myalgias, chills, swollen lymph node in injected arm, ftigue/weakness, nasal congestion",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,,,,,,"['Asthenia', 'Chills', 'Fatigue', 'Injection site pain', 'Lymphadenopathy', 'Myalgia', 'Nasal congestion']",2,PFIZER\BIONTECH,IM 933583,TN,34.0,F,approximately 1 week after my vaccination i started experiencing a large injection site rash that quickly spread to my forearms and hands to include my fingers. The rash has also spread to my legs and feet as well as my ears and nose . The rash consist of large red extremely itchy bumps / hives,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/05/2021,6.0,PVT,Lisenopril,none,none,,Augmention,"['Dermatitis acneiform', 'Injection site rash']",1,MODERNA,IM 933585,NY,32.0,F,"30 mins after receiving the vaccine, I started feeling my tongue more in my mouth. I also experienced difficulty breathing. I was told that my lips and cheeks were swollen and that my eyes were red. I was first given benadryl (25 mg) and prednisone (20 mg). I was later given epinephrine ( 0.3 mg/0.3mL injection). I was then taken to the emergency room where they prescribed the above medications to be taken for 3 days (minus the epinephrine).",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,WRK,Lo Loestrin Fe 1mg/10mcg Topical medications,None,None,,"Allergic to shrimp, salmon, peanuts, almonds, cockroach, dust mite, mold, cat, dog, tree pollen, grass pollen, weed polled, ragweed pollen","['Dyspnoea', 'Lip swelling', 'Ocular hyperaemia', 'Swelling face', 'Swollen tongue']",1,MODERNA,SYR 933586,OK,31.0,M,"Chills, body aches, fatigue, sweating",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,MIL,,,,,,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Pain']",2,PFIZER\BIONTECH,IM 933587,VA,31.0,F,"Severe arm pain and injection site reaction, red/pink puffiness and pain around injection site. Neck, shoulder and back pain on side of the injection that has not gone away after 2 weeks. Injection site reaction went away after 4 days but then came back 9 days after shot and was pink and itchy, the size of an orange. Lasted 1 day then slightly went away again. Neck, shoulder and upper quadrant left sided pain still occuring, stiffness and tightness. Fatigue also has lasted 2 weeks since injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,Magnesium 500mg Xyzal 5mg Zoloft 200mg Fiber Probiotic,None,None,,Penicillin,"['Abdominal pain upper', 'Back pain', 'Chest discomfort', 'Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Musculoskeletal stiffness', 'Neck pain', 'Pain in extremity']",1,MODERNA,SYR 933589,KY,65.0,F,"2-1/4"" by 1-3/4"" red rash, itching on underside of left arm, 2 "" from wrist",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,OTH,"Pantoprozol Sodium 20 mg, hydrochlorothiazide 12.5mg, Memantine HCL 5 mg, Acetaminophen 500 mg",,"Arthritis of the left knee 5/2019, traumatic brain injury 6/2020",,"Lisinopril, mobics, codeine, pen vk, latex, calamari,","['Rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 933590,NY,44.0,F,"12/30 - Arm soreness directly after injection; flu symptoms started about 3 hours after injection (99.5 temperature, headache, body ache, low energy and chills). 12/31 - 7am 101.1 fever; worsening of all above symptoms plus nausea; 8/10 headache; symptoms persisted through the afternoon and started to resolve in PM 1/1 - all symptoms resolved and temperature 97.4",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Asthenia', 'Chills', 'Headache', 'Immediate post-injection reaction', 'Influenza', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 933591,IN,35.0,M,"Body aches, headache, chills, soreness in arm. Resolved in about 12 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,,,,,,"['Chills', 'Headache', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 933592,IL,51.0,F,"/Vaccination administered on 12/30/2020 Experienced soreness for about 24 hours post vaccination which cleared. 01/07/2021 itching, redness and site was warm to touch. 01/ 09/2021 contacted my MD. Recommended Zyrtec and hydrocortisone (working diagnosis: delayed allergic reaction-asked to contact her if not better, may be developing a cellulitis) 01/09/2021 took Zyrtec 01/10/2021 took Zyrtec and applied hydrocortisone 01/11/2021 work up with tingling in the arm . Contacted MD. waiting on response. Took 1 zyrtec.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/11/2021,12.0,PUB,"Zyrtec , Vitamin C, Vitamin D, Multivitamin",Sinus inflammation with post nasal drip. Taking zyrtec and usning flonase,,,No known medication or food allergies. Allergic to bandage adhesive,"['Erythema', 'Injection site warmth', 'Pain', 'Paraesthesia', 'Pruritus']",1,MODERNA, 933593,IN,28.0,F,"My whole body ached a few hours after injection, I become nauseous and vomited, and I had chills. The next day I had a bad migraine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/11/2021,2.0,PVT,Lexapro,None,None,,Penicillin,"['Chills', 'Migraine', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,SYR 933594,IN,57.0,F,"Second Dose: Felt nasal congestion after receiving the shot, then 24 hours later, I started feeling aching all over. Then the next day, I awoke with a warm area around injection site. Warm to touch, and is very tender.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/11/2021,3.0,PVT,"Metformin 1000mg, Jardians 10mg, Celibrex 100mg,",No,Arthritis and Diabetic Type 2,,"Penicillin, Demerol","['Injection site pain', 'Injection site warmth', 'Nasal congestion', 'Pain']",UNK,PFIZER\BIONTECH, 933596,OH,27.0,F,"Following say I had body ache and headache that began upon awakening at 9 am; relieved with ibuprofen. Headache returned in the afternoon and by evening I had developed 99.2F fever, chills, and muscle aches, headache and nausea. This was relieved with Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,took Tylenol and Motrin to help with side effects from vaccine,,Charcot marie tooth disease type 1A,,sulfa,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 933598,FL,34.0,F,"Hot Red mark appeared on day 8. Did a telehealth appointment and they put me on Keflex for cellulitis, I was told to go to the ER if it got bigger. It got bigger last night, I had a fever, went to the ER they had to cut and drain it and then pack it. They told me at the ER the vaccine was not given in the correct spot.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/09/2021,7.0,OTH,"Bendryl, Pepcid",None,Anemia,,Reglan and Infed,"['Cellulitis', 'Culture wound', 'Drainage', 'Erythema', 'Feeling hot', 'Product administered at inappropriate site', 'Pyrexia', 'Wound treatment']",1,MODERNA,IM 933599,IN,33.0,F,"Chills, fever, body aches, fatigue, head ache. Most lasting 24 hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 933601,TN,26.0,F,"Approximately four hours after receiving the COVID-19 vaccine I felt injection site pain. During the night I began experiencing muscle aches, chills, headache, and just an overall feeling of pain/flu like symptoms. This lasted for approximately 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,None,None,None,,None,"['Chills', 'Headache', 'Influenza like illness', 'Injection site pain', 'Myalgia']",1,PFIZER\BIONTECH,SYR 933602,CT,52.0,F,"PAIN AT SITE NEXT DAY HEADACHE, FATIGUE AND INCREASED PAIN WED JAN 6, TH JAN 7, FRI JAN 8 I HAD TELMED SESSION WITH DR, ALSO NEGATIVE RAPID COVID TEST DR CALLED ME BACK AND ORDERED CEFUROXIME AXETIL 250MG; STARTED FRI JAN 8 2021 AT 900PM RASH HAD SPREAD NOTICED MORNING OF SAT JAN 9, I CALLED PCP AND THEY RECOMMENDED VISIT TO ER/WALK IN. WALKIN SAID THEY COULD NOT HELP IF I WAS ON ANTIBIOTICS SO I WENT TO ER AND THEY TRACED SITE AND ASSURED ME TO COME BACK IF SPREAD CONTINUED. (RASH RESOLVING 01/11/21)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,PVT,ESCITALOPRAM OXALATE 10MG AND PROAIRHFA AS NEEDED,NONE,ASTHMA,,NONE,"['Fatigue', 'Headache', 'Injection site pain', 'Pain', 'Rash', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 933603,TX,36.0,M,"I began experiencing soreness at injection site and pain in right arm pit approximately 6 hours after vaccination, approximately 4-5PM. Approximately 10 hours after vaccination i felt very fatigued and tired and went to bed early. Approximately 12 hours after vaccination I woke from sleep with fevers (101.8), chills, and headache. I took tylenol, fever subsided, and was able to return to sleep at approximately 4:00AM. I woke at 6:30AM with headache, dizziness, and fever (99-100). I took more tylenol and fever and headache subsided. For remainder of day temperature would start in increase, but stayed below 99, and headache would return between doses of tylenol. I slept through the night of 1/9/2021 and woke 1/10/2021 without fever or headache, although I would experience dizziness with exertion above level of walking. Today, 1/11/2021, I am not experiencing any symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,None,None,None,,Bee stings,"['Axillary pain', 'Chills', 'Dizziness', 'Dizziness exertional', 'Fatigue', 'Headache', 'Injection site pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933604,OK,48.0,F,"1 day after had body aches, fever, and chills, also developed a small red rash at injection site. Day 2 - body aches went away but rash became itchy and very sore - redness spread on arm. Day 3 - continued redness and soreness with itchiness. Day 4-5 - redness has subsided but still some soreness and itchiness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,OTH,"propranolol, birth control, potassium, water pill, fluoxetine",none,no,,None that aware of,"['Chills', 'Erythema', 'Injection site rash', 'Pain', 'Pyrexia', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,SYR 933605,GA,42.0,F,"extreme fatigue, nausea, headache, diarrhea, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/07/2021,3.0,PVT,nucynta 150mg every 12 hours; nucynta 50mg extended release as needed; diltiazem twice a day; metoprolol 50mg twice a day; tizanidine twice a day; lisinopril 40mg twice a day; lidocaine patches every 12 hours; voltaren cream to knees as n,Denies any recent new illness,Sinusitis Hypertension Tachycardia Hx of back injury with nerve damage,,Denies any allergies,"['Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Nausea']",1,MODERNA,IM 933607,IN,48.0,F,"extreme fatigue (began about 24 hours post-injection, resolved within 12 hours), chills (began about 28 hours post-injection, resolved within 8 hours)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,"Trulicity, naproxen, lisinopril, gabapentin, pravastatin",,diabetes,,none,"['Chills', 'Fatigue']",2,PFIZER\BIONTECH,IM 933608,MT,31.0,F,"Moderna covid vaccine administered 1720 Hx of anaphylaxis to flu shot ?about 8 years ago? (of note, was not intubated/admitted/etc) Patient requested extended monitoring due to hx. Placed in wheelchair at pharmacy station. 1730 patient states a scratch throat and itchy nose. Able to swallow water provided. 1800 patient continues to experience throat ?lump? and is clearing throat, nose itches Requests diphenhydramine-given 25mg PO x 1 ingested without issue 1830 patient complains of itchy scalp and has a red flush to chest and upper arms 1832 patient wheeled to ER by From ED note: Electrocardiogram was without acute change. The patient was observed in the emergency department, is feeling much improved. Still has a very slight sensation of a lump in her throat, but no angioedema of lips or tongue. No stridor. No shortness of breath. O2 sat is excellent at 100%. She is comfortable being discharged to home. No meds given in ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,none,none,Influenza vaccine,influenza vaccine -,"['Electrocardiogram normal', 'Erythema', 'Flushing', 'Pruritus', 'Sensation of foreign body', 'Throat clearing', 'Throat irritation']",1,MODERNA,SYR 933609,IN,31.0,F,"Aprox 24 hours after vaccine, headache developed and lasted aprox 24 hors. 7 days after vaccine, swollen, tender lymph node in armpit of same arm that received vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,UNK,Prozac,,"Depression, anxiety",,Penicillin allergy-mild,"['Headache', 'Lymph node pain', 'Lymphadenopathy']",UNK,MODERNA,SYR 933610,PA,66.0,F,Itchy and painful area around injection site; indurated area around injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/29/2020,6.0,PVT,,,,,,"['Injection site induration', 'Injection site pain', 'Injection site pruritus']",1,PFIZER\BIONTECH,IM 933611,NY,29.0,M,"Received around 7-8pm on 12/22. Woke up 12/23 feeling okay, just L arm soreness however as day went on progressively worsening chills, myalgias, malaise, headache, and extreme weakness/fatigue. Lasted 24-48 hours, peaking around 24-36 hours. Necessitated sick call out from work. Of note I had Covid in March and had antibodies prior to vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,PVT,none,none,none,,none,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Impaired work ability', 'Malaise', 'Myalgia', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 933612,MO,37.0,F,Rash Transient Flushing Tachycardia,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Flushing', 'Rash', 'Tachycardia']",1,MODERNA,IM 933614,PA,36.0,F,"Moderna COVID 19 Vaccine EUA after 12 hours - abdominal pain/cramping with one episode of diarrhea 12-24 hours - nausea and fatigue improved day 1-2 pain at site of injection, resolved by day 3 - no redness or itching day 3-4 TMJ pain on side of injection Day 5 developed two painful palpable enlarged supraclavicular lymph nodes on side of injection - Started taking ibuprofen around the clock, seems to be improving slowly Day 6 - developed swelling, redness, and itching at site of injection, seems to be growing in size. Greater than a half dollar in size. Continuing NSAIDS, applying cortizone cream. Day",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,Zyrtec - seasonal allergies,No,No,,Amoxicillin,"['Abdominal pain', 'Diarrhoea', 'Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Lymph node pain', 'Lymphadenopathy', 'Nausea', 'Pain in jaw']",UNK,MODERNA,IM 933616,IN,28.0,M,"Awakened 4 times shivering, Headache- relieved with 1 gram of Tylenol. dizziness- resolved 3-4 hours after waking. Fatigue- slept for 13 hours after working Body aches (mainly lower extremities)- worsened above movement. Dull ache while at rest. resolved with time. Hot flashes- random hot flash with sweating. Still experiencing almost 48 hours after immunization.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/10/2021,1.0,PVT,,,,,,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Hot flush', 'Hyperhidrosis', 'Pain', 'Sleep disorder']",2,PFIZER\BIONTECH, 933617,MD,29.0,F,"Day 6 after vaccine had tenderness in left armpit, the evening of day 7 noticed a rash the about 1.5 inch in circumference over injection site, accompanied by swelling, hardness and heat to touch. Day 8 the rash has increase to 2 inches in circumference and the overall size and hardness became more defined. Lifting the arm has become painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/09/2021,6.0,PVT,"Lunel Fe, Probiotic, Multivitamin, Fish Oil",,,,Azithromycin,"['Injection site induration', 'Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Tenderness']",1,MODERNA, 933618,IN,40.0,F,"fatigue, headaches, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,"Vit D, Xyzal, Incruse",UTI,Asthma,,None,"['Fatigue', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH,IM 933620,TN,54.0,F,"Upper arm itch on January 9th. Woke up January 10th with a rash on the upper left arm muscle. Also felt warm to the touch and muscle felt hard. I took 25mg of diphenhydramine on the morning of the 10th. By the evening, the rash was gone except for an outline around the muscle. Muscle still felt warm but no longer felt hard. Took 25mg of diphenhydramine before bedtime. Woke up morning of 11th with a very faint rash outline. Hardness was gone, but muscle still feels warm to the touch. No other symptoms and not affecting my daily activities.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/09/2021,7.0,PUB,"Vitamin B complex, Calcium , and Vitamin D",None,None,,None,"['Injection site induration', 'Injection site rash', 'Injection site warmth', 'Pruritus']",1,MODERNA,IM 933621,,26.0,M,"Myalgia, chills, low grade fever occurring 12 hours after first injection and lasting for 10 hours after onset. Sx treated with Tylenol PRN",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,UNK,Cymbalta 60mg,None,Depression,,Keflex (hives),"['Chills', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 933623,IN,33.0,F,"Chills, fever, body aches, weakness, fatigue, fever, headache. All lasting about 24hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,,,,,,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933625,FL,40.0,F,"shoulder injury following vaccination. suspect SIRVA. Extreme shoulder pain started a few hours after vaccination and developed loss of range of motion, weakness, inability to lift arm, tingling and numbness down the length of arm. Severe pain prohibiting ADLs; needing assistance with every day functions. Pain is incrementally improving but after 4 days still without recovery. Suspect nurse placed too high, injecting into bursa instead of deltoid muscle. RN seemed concerned after injection. She also was not sitting during injection, increasing the likelihood of injecting too high.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Zyrtec, docusate, vitamin D, vitamin C",none,rhinitis,,none,"['Arthralgia', 'Asthenia', 'Complication associated with device', 'Hypoaesthesia', 'Injection site injury', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Paraesthesia', 'Shoulder injury related to vaccine administration']",2,PFIZER\BIONTECH,IM 933626,IN,43.0,M,"Vaccine received at 0940 on 1/7 and at 0300 on 1/8 I woke up with low grade fever, chills and body aches. Extra strength Tylenol was taken mid afternoon on 1/8 and felt much better and no symptoms when I woke up on 1/9.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PUB,None,None,Polycystic Kidney Disease,,None,"['Chills', 'Pain', 'Pyrexia']",1,MODERNA,IM 933627,TX,56.0,M,approximately 40 minutes after the vaccine I developed a mild head ache that lasted about 1/2 hour. That night I woke up due to injection site pain that lasted through the night. Friday morning I realized my lymph node was swollen. By Saturday all symptoms had resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,None,light head cold,None - did test positive with COVID last June and ran 102+ temp for 8 days straight and was SOB for 6 weeks after returning to work.,,NKA,"['Headache', 'Injection site pain', 'Lymphadenopathy']",1,MODERNA,IM 933629,FL,29.0,F,"Injection site swelled (4"" diameter), was extremely hot to the touch, and very painful start about four hours after the shot. By that evening, I was extremely achey and feeling flu-like symptoms. Extreme headache began next day and lasted for 1.5 days. Fever was never confirmed, but I had chills and could not warm myself. Swelling and redness lasted two days. Swelling was circular around injection site--still swollen now/4 days after. Aches lasted about 2 days. Once the redness subsided, the injection site became extremely itchy and still is to date. Please note, I am 10 months postpartum and still breastfeeding.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Postnatal Vitamin,None,None,,None,"['Chills', 'Feeling cold', 'Headache', 'Influenza like illness', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Maternal exposure during breast feeding', 'Pain']",1,MODERNA,IM 933630,IN,53.0,F,Started with a headache and tiredness on Friday evening. Then Saturday strong body aches and mild headache. Sore arm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"High blood pressure, allergy, reflux meds",Covid 19 starting on Nov 30,,,3 high blood pressure meds and Wellbutrin,"['Fatigue', 'Headache', 'Pain']",1,MODERNA,SYR 933631,IN,43.0,F,"Left axillary lymphadenopathy, fatigue/body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/11/2021,2.0,PVT,Citalopram Welbutrin,Cough,Obesity,,none,"['Fatigue', 'Lymphadenopathy', 'Pain']",2,PFIZER\BIONTECH,IM 933632,LA,56.0,F,"Fever, chills, body aches, injection area red and warm to touch started the next day",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,OTH,"Amlodipine 10mg., Loratadine",Allergic rhinitis,"Vertigo, esophageal reflux, HLD, Htn, Anemia, Lumbago, Peripheral vascular disease, premature ventricular contractions",,NKA,"['Chills', 'Injection site erythema', 'Injection site warmth', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 933634,NC,30.0,F,"12/30 Vaccination. morning Moderate L deltoid pain 4:15 fatigue, HA, body aches. 7pm; 2 hours later temp 101.2, HR increase, jaw pain, HA, unable to sleep. Tylenol at 9pm 12/31/2020 same symptoms. HR still up, achy. same symptoms, fever, nausea, body aches, persistent arm pain. Bruising at site of injection. 1/1/2021 HA, body ache, fatigue, body ache; Tylenol. 1/2/2021; mild HA, mild arm pain, bruising at injection site (visible day after day of vaccination). *HR increase lasted till 1/2/2021. Lack of sleep lasted 2 nights. Called colleague in urgent care. COVID test; negative *COVID + in July **2nd pregnancy. Due May 2nd ***ABLE AND WILLING TO BE PART OF PREGNANCY VACCINATION STUDY",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,Prenatals; Magnesium 250 mg; Vitamin D,,,,,"['Arthralgia', 'Body temperature increased', 'Fatigue', 'Headache', 'Heart rate increased', 'Injection site bruising', 'Insomnia', 'Nausea', 'Pain', 'Pain in extremity', 'Pain in jaw', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 933635,MO,31.0,M,Fever and chills,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Gabapentin Probiotics,None,None,,None,"['Chills', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 933636,NY,25.0,F,"Left sided facial drooping, facial numbness, visual changes. Diagnosed with Bell's Palsy related to Covid vaccine. Onset 1/1/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/01/2021,2.0,OTH,,,Anxiety and Depression,,,"['Facial paralysis', 'Hypoaesthesia', 'Visual impairment']",UNK,PFIZER\BIONTECH,IM 933637,GA,41.0,F,fever chills HA body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,HCTZ,no,no,,no,"['Chills', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933640,IL,47.0,F,"Metallic taste in mouth for 5 to six minutes after injection. Body aches 4 hours later, able to sleep after 2 Aleve.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,"Hydrochlorathiazide, levothyroxin, pantoprazole, crestor, famotadine, sudafed, mucinex, Citalopram, valarian root, gabapentin",none,"HTN, hypothyroidism, GERD, depression",,none,"['Dysgeusia', 'Pain']",2,PFIZER\BIONTECH,IM 933641,WI,29.0,F,"Chills, cyanosis of fingernail, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,,,,,,"['Chills', 'Cyanosis', 'Nausea']",1,PFIZER\BIONTECH,ID 933642,LA,48.0,F,Urticarial rash to arms 5 min after vaccine given resolved within 1 hour.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,"azelastine, bupropion HCL, levothyroxine, lorazepam, losartan, montelukast, Ozempic, Symbicort",,"Hypothyroidism, essential hypertension, mixed depression and anxiety disorder, allergic rhinitis, prediabetes",,NSAIDs,"['Rash', 'Urticaria']",1,MODERNA,IM 933643,IN,52.0,F,"""Pfizer-BioNTech COVID-19 Vaccine EUA"" woke up feeling generally unwell, fever of 100.5 and fatigue. Resolved by the next morning of 1/2/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,"flovent, bisoprolol/hctz, fish oil, coq10, chromium, catalyn, turmeric, fish oil, vitamin c, vitamin d3",none,"asthma, HTN",,"peanuts, tree nuts, sulfa","['Fatigue', 'Malaise', 'Pyrexia']",1,PFIZER\BIONTECH,IM 933644,KY,51.0,F,Pt complained of feeling light headed and flushed. Pt was given an IM Benadryl 50 mg injection and stated that she felt better after receiving vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,none,none,none,,NKA,"['Dizziness', 'Flushing']",1,MODERNA,IM 933645,ME,40.0,F,"When I woke up the next day (1/3/21), my entire upper arm felt like I had been beaten up. I was having chills, and fatigue. The chills subsided on 1/4/21. The arm pain started to subside 1/6/21, to the point where it was just the area where the shot was administered, but still hasn't gone away. It still hurts to move that muscle. The pain is worst in the morning, but my arm will loosen up by the afternoon. The pain doesn't go away completely. It hurts to lift or push if that muscle is involved. I have not been able to sleep comfortably because if it. I have been taking advil and tylenol multiple times a day, as well as trying hot packs on my arm at night.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,PVT,None,None,Achelasia (corrected with a Heller-Dor in 2019) PCOS,,"Flonase. Penicillin, scallops, nicole, dust, cats","['Chills', 'Fatigue', 'Injection site pain', 'Pain', 'Pain in extremity', 'Sleep disorder']",1,MODERNA,IM 933647,PA,47.0,F,Upon awakening on the day after receiving vaccine she noted a red non-itchy rash on her neck.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,Advil 600mg alternating with Tylenol 1000mg. Clindamycin 150 mg TID started on 01/07/2021.,dental abscess,none,states reaction to mumps vaccine as a baby. Is not sure of the presenting symptoms.,penicillin,['Rash erythematous'],1,PFIZER\BIONTECH,IM 933648,VA,53.0,F,"Chills and shakes without fever, weakness, and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,MIL,"vitamins, omega 3. vitamin c, d, Amberen, motrin, tylenol",5 weeks post positive COVID,"hypertension, GERD",,"penicillin, sulfa, synthetic codeine","['Asthenia', 'Chills', 'Headache', 'Tremor']",1,PFIZER\BIONTECH,IM 933650,ME,27.0,F,"Employee reported they experienced uveitis (reportedly diagnosed at visit with ""eye doctor"") with an onset of about two weeks from getting the first dose of the Pfizer SARS-CoV-2 vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/31/2020,14.0,PVT,,,,,,['Uveitis'],1,PFIZER\BIONTECH,IM 933651,NY,50.0,F,Friday evening 2 hours after dinner my sugar reading was 220. My sugar levels never go over 150 after a meal. My diabetes is under control,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,Simvastatin� 40mg Omeprazole dr 40mg ? Azelastine chi 0.15% Zertek Metformin hcl er 500 mg 2 pills twice a day Levothyroxine 10 mcg 1 baby aspirin Calcium� 1000� 1 daily w/ vitamin d,,Diabetic,,,['Blood glucose increased'],1,PFIZER\BIONTECH,SYR 933652,TX,36.0,F,"Chills, body aches, fatigue, lower back pain, and eye pain. No treatment. minor improvement will continue to monitor",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Back pain', 'Chills', 'Eye pain', 'Fatigue', 'Pain']",2,PFIZER\BIONTECH,IM 933653,NJ,32.0,F,ongoing swelling of left axillary - underarm pain and swelling tiredness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,lovenox 100 mg once/daily,,,,Shell fish,"['Axillary pain', 'Fatigue', 'Swelling']",2,PFIZER\BIONTECH,IM 933655,TX,43.0,F,"injection site armpit/ lymph node swelled and was EXTREMELY palpable and painful... unable to close my armpit as of today 1/11/2021, swelling has reduced but still painful",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,OTH,Metoformin 1000,"none... i did not have this reaction when i took my fist dose of pfizer.... injection site armpit lymph node swelled and was palpable and painful... unable to close my armpit as of today 1/11/2021, swelling has reduced but still painful",Diabetic,,Isovue Iodine ( ct contrast),"['Axillary pain', 'Injection site swelling', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 933656,VT,34.0,F,"I developed a headache about 1 hour after the vaccine. I developed a fever of 100.4 about three hours after my first dose of the COVID-19 shot. Shortly after this I had moderate GI upset including diarrhea, cramping for about 24 hours. Over the course of 48 hours after the vaccine I had swelling at the injection site, tenderness of the injection area to the point where I was not able to put pressure on the area or sleep on my left side and severe fatigue/malaise. All symptoms resolved after 48 hours. I am a person and wanted the reaction information to be part of the trial data.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Aviane- oral contraceptive once daily Flucticasone Nasal Spray 2 sprays into nostril once daily Zyrtec 10mg 1 tab once daily Flovent 110mcg 1 puff once daily,None,Asthma,,NKDA,"['Abdominal discomfort', 'Diarrhoea', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Malaise', 'Muscle spasms', 'Pyrexia']",1,PFIZER\BIONTECH,IM 933657,VA,40.0,F,"Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain under the arm pit close to my breast on the arm of vaccine, weak ,lightheaded, sweating, headache,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,Levothyroxine. Metformin,None,DiabeteS,,None,"['Anxiety', 'Asthenia', 'Axillary pain', 'Dizziness', 'Feeling hot', 'Headache', 'Hyperhidrosis', 'Palpitations', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 933659,TX,36.0,F,"Moderna COVID-19 Vaccine EUA I have a golf ball size supraclavicular lymph node above the left clavicle bone, which has grown larger over the course of the last few days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/06/2021,3.0,PUB,"Crestor, Paxil, vitamin C, B12, zinc, and calcium",No other illnesses,High cholesterol,,Sulfa,['Lymphadenopathy'],1,MODERNA,SYR 933660,MN,75.0,F,"sub-q tissue to R deltoid area remains reddened, swollen and warm to the touch. Injection site is firm. Resident reports area is painful to the touch. Area measures approximately 5"" x 5"". Resident is morbidly obese with excessive adipose tissue to upper arms. Staff applying cool compresses throughout the day, and administering Tylenol for comfort.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,SEN,"Montelukast Sodium Tablet, Atenolol Tablet 25 MG, Magnesium Oxide Tablet, Symbicort Aerosol 160-4.5 MCG/ACT, Vicks VapoRub Ointment, metFORMIN HCl ER Tablet, Ergocalciferol Capsule 1.25 MG, Voltaren Gel 1 %, Bumex Tablet, Omeprazole Capsule",No,"MORBID (SEVERE) OBESITY WITH ALVEOLAR HYPOVENTILATION, PRIMARY GENERALIZED (OSTEO)ARTHRITIS, LEFT VENTRICULAR FAILURE, UNSPECIFIED, TYPE 2 DIABETES MELLITUS WITH DIABETIC CHRONIC KIDNEY DISEASE , CHRONIC OBSTRUCTIVE PULMONARY DISEASE WITH (ACUTE) EXACERBATION, UNSPECIFIED ATRIAL FIBRILLATION, MAJOR DEPRESSIVE DISORDER, RECURRENT, UNSPECIFIED, ANXIETY DISORDER, CHRONIC PAIN SYNDROME, MUSCLE WEAKNESS (GENERALIZED), MILD INTERMITTENT ASTHMA, CHRONIC MIGRAINE WITHOUT AURA, NOT INTRACTABLE, WITHOUT STATUS MIGRAINOSUS, GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS, OSA, LONG TERM (CURRENT) USE OF ANTICOAGULANTS, HTN",,"latex, narcotics","['Incorrect route of product administration', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 933661,IL,51.0,M,"Extreme soreness to injection site, Flu-like symptoms including nausea, headache, fatigue, body aches, chills (during the evening), and mild diarrhea. Most symptoms were better by 6 PM on 1/9/2021. Diarrhea better by 1 PM 1/10/2021. (I had NONE of these after the first vaccination.)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Enalapril, Vitamin D supplement",None,Hypertension,,No known allergies,"['Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Influenza like illness', 'Injection site pain', 'Nausea', 'No reaction on previous exposure to drug', 'Pain']",2,PFIZER\BIONTECH,IM 933662,IN,62.0,F,"Fatigue and headache the 1st day. Abdominal pain, Nausea and vomiting , headache and fatigue the 2nd day. 3rd day fatigue and muscle aches. 4th still having fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"Aleve, amlodipine, omeprazole",Crohns,Crohns,,"Codeine, shrimp, Cipro, pcn, morphine, tramadol, dexilant, raloxifene, Alendronate, risedronate,ivandronate, saccharomyces boulardii, hydrocodone-acetaminopen","['Abdominal pain', 'Fatigue', 'Headache', 'Nausea', 'Vomiting']",1,MODERNA,SYR 933664,KY,58.0,F,I started to have dizziness/ lightheadedness about 1 hour after the injection went home and got in bed for the rest of the day. On the next day more dizziness and elevated blood pressure I was unable to finish my shift. Called employee health they documented I told them how high my blood pressure was their advice was see my PCP or go to the nearest emergency room. I called my PCP she had me to increase my amlodipine to 10 mg and fluids followed by rest and to monitor my blood pressure.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,WRK,"amlodipine 5 mg, duloxetine 30mg, Toprol-xl 100 mg, levothyroxine 50 mcg, vitamin d 50,000 a week",I experienced dizziness and fatigue along with pain in back of my head elevated blood pressure,Hypertension and thyroid from partial removal,Flu vaccine,Codeine and Morphine,"['Blood pressure increased', 'Condition aggravated', 'Dizziness', 'Impaired work ability']",1,MODERNA,IM 933665,IN,39.0,F,Fever chills headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/09/2021,8.0,OTH,None,Pneumonia,None,,None,"['Chills', 'Headache', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 933666,OH,50.0,F,"On 1/8/2021 (eight days post-vaccination), a raised, red, and itchy region appeared around the injection site approximately the size of a quarter. On 1/9/2021, the reaction around the injection site stayed the same and the 2 lymph nodes distal to the injection site became swollen and red as well. On 1/10/2021, both reactions substantially subsided and are absent on 1/11/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/08/2021,8.0,WRK,none,none,none,,none,"['Erythema', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Lymphadenopathy']",1,MODERNA,IM 933667,,37.0,F,Neuropathy in vaccinated arm for a couple hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,['Neuropathy peripheral'],2,PFIZER\BIONTECH,IM 933668,GA,43.0,M,"Significant fever for about 48hrs (first fever of my adult life). Aches, pains, chest pains, increased secretions and coughing, fatigue. It was like my body thought I was sick with COVID again. But in some ways it was worse. I was afebrile with the real virus.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,na,"Actually COVID positive, diagnosed 12/17/2020",na,,PCN,"['Chest pain', 'Cough', 'Fatigue', 'Increased upper airway secretion', 'Pain', 'Pyrexia']",1,MODERNA,IM 933670,IN,,F,"Patient received Moderna covid vaccine, and shortly after became lightheaded. Client lied on the floor, applied a cool compress to back of neck. Client was able to sit up shortly after, and was able to leave home. No further treatment required.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,['Dizziness'],1,MODERNA, 933671,IN,38.0,M,"Chills, fever up to 102.3",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/10/2021,1.0,PVT,Lisinopril Fenofibrate,,,,,"['Chills', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 933672,NE,59.0,F,"Vaccinated in left deltoid at 3:00pm by 7:00pm in the evening uncontrollable pain in left arm down to fingers and up to shoulder, decreased mobility. No redness or swelling at injection site. Patient seen by medical provider and received toradol IM in clinic for pain. This relieved the pain until 9:00pm Saturday 1/9/21 and then the pain returned back to 9/10. Patient received PO pain medication Sunday AM. This helps bring pain down to 5/10. Pain is mainly with movement. If arm is stabilized pain is decreased. Patient still in pain this morning 1/11/21 and unable to work today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,None,None,None,,None,"['Impaired work ability', 'Injected limb mobility decreased', 'Pain in extremity']",1,MODERNA,IM 933673,NC,62.0,F,Patient's reaction(s) noted during COVID vaccine observation period: Pain on left side of neck (same side as injection site) ) and waves of nausea. Actions Taken: VS taken and WNL. Pt states the nausea is resolving and she feels comfortable just going home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,,,,,,"['Nausea', 'Neck pain']",1,PFIZER\BIONTECH,IM 933676,TX,49.0,F,"Muscle Aches, very sore arm at injection site, nausea, low grade fever, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PHM,,,,,Penicillin,"['Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Pyrexia']",UNK,MODERNA, 933677,NY,37.0,F,Back rash,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,,,,,,['Rash'],1,PFIZER\BIONTECH,IM 933678,IL,57.0,F,"Sore throte, headache, body aches, wet couph, glands are swollen, and runny nose",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,PVT,"3 different Glaucoma eye drops, Atorvastatin 10mg , Atenolol 25mg, Xildra eye drops",none,Mytrovalve Prolapse and Glaucoma,,none,"['Headache', 'Lymphadenopathy', 'Oropharyngeal pain', 'Pain', 'Productive cough', 'Rhinorrhoea']",2,PFIZER\BIONTECH, 933679,FL,50.0,F,"about 10 min after the injection as I was sitting in the waiting area I got a hot feeling come over me and I felt the color drain from my face and I felt like I was going to ""pass out"" it passed after about 15 seconds and I felt fine. I waited 30 min from vaccine time to make sure I was going to be ok. At 5:30 pm on 1/6/21 I noticed I stared itching my right arm around the inside of the elbow. I noticed my vision blurring and I had a sudden onset of a Horrific headache. By 6 pm I was itching very severely. It was as if I was clawing at my skin. I called one of the dr's I work with and he called me in a medrol dose pack. I started the dose pack at 8:30 pm on the 6th. The headache continued, I tried motrin, fiorcet, and oxycodone with no relief. I still have the headache but it is not as intense as it was. I was up all night itching and dealing with the headache by the am , my jaw was visibly swollen and it felt like I had been in a fight. I was not able to go to work on 1/7/21 and could only work 1/2 day on 1/8/21. the itching did not subside much till sat 1/9 but is coming back as I taper down off the steroids. My last pill was this am. The jaw pain and swelling lasted till sat night and is subsiding daily. I may have to call my pcp and be seen this week.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,levothyroxine 200mcg,none,"migraines , thyroid replacement due to removal of thyroid. multiple orthopedic surgeries.",flu vaccine in early 2000's,"imitrex, bleach, cigarette smoke did have a reaction to the flu vaccine 2003-2005 not sure which years exactly but I took again it after the first reaction as we were not sure if it was the flu vaccine or something else. I did not take the flu again until 2 years ago and I have had no problem with the flu vaccine the last 2 years.","['Dizziness', 'Feeling hot', 'Headache', 'Impaired work ability', 'Pain in jaw', 'Pruritus', 'Skin discolouration', 'Swelling face', 'Vision blurred']",1,MODERNA,IM 933680,NY,30.0,F,"Sore arm day 2 and 3, Day 2: headahce, mild fatigue day 3 also began with left sided axillary lymphadenopathy. Day 5: improved all of the above",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/1921,,PVT,nothing,no,none,,"PCN, Aspirin (hives)","['Fatigue', 'Headache', 'Lymphadenopathy', 'Pain in extremity']",1,MODERNA, 933681,IN,66.0,F,"Low grade fever which lasted 24 hours. Raised, reddened area at site of injection also as well as significant left axillary lymph node enlargement which both persist.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,"Centrum multivitamin, Areds vitamins, Vitamin D, Lisinopril w HCTZ, Flonase, Flovent, Atorvastatin","New diagnosis (symptoms started in August 2020) of granuloma annulare, confirmed by biopsy December 2020.","Well-controlled asthma, hypertension, obesity, sleep apnea",,Sulfonamides,"['Injection site erythema', 'Lymphadenopathy', 'Pyrexia', 'Rash papular']",2,PFIZER\BIONTECH,IM 933683,TX,59.0,F,"06:fever, body aches, Headaches, soreness-left arm-99.7-T 07th:& 8th: Headaches & fever-more than the 6th, 99.9-T Sat the 9th vomiting 2 times---she took Tylenol 325mg times 2 for her fever-T-99.7 Sunday the 10th vomited 10 times-99.9 T This Am the 11th of January@0100-cramping--------99.1 T",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,MIL,"Flonase, multi-vitamins, Tylenol",none,none,,"sulfa, peach mango","['Body temperature decreased', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 933684,OH,38.0,F,"Starting three days after injection, swollen lymph nodes and slight headache. Starting on day 6 post administration, arm was red, swollen, tender at injection site. Redness spread over the next 2 days. Medicated with OTC benadryl cream and symptoms resolved 11 days after injection. Patient reported fever of 100.4 on day 10 post administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/03/2021,4.0,PVT,None,None,Hypothyroidism,,None,"['Erythema', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy', 'Pyrexia']",1,MODERNA,IM 933685,IN,43.0,F,"Body aches, chills, sore throat, headache, low grade fever, fatigue-approximate 12 hours Alternate TYL and IBU",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Lisinopril 40mg daily Amlodipine 10mg daily Metformin 500mg 2 tablets daily Ozempic 1mg weekly Vitamin D 2000 units daily,none,Hypertension Type 2 Diabetes,,codeine,"['Chills', 'Fatigue', 'Headache', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933687,TX,36.0,F,"Chills, body aches, fatigue, lower back pain, eye pain. No treatment with minor improvement",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Back pain', 'Chills', 'Eye pain', 'Pain']",2,PFIZER\BIONTECH,IM 933688,LA,29.0,F,"Intermittent headache starting one hour post and persisting through the next day. Fever, back ache, fatigue, injection site tenderness, and swollen lymph node to right neck, started morning after vaccine and resolved by second day after vaccine. Took Tylenol twice. Swollen lymph node under right arm, starting morning after vaccination; has reduced but remains present.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,Amitriptyline 50mg PO DLY Levothyroxine 175mcg PO DLY.,,"PCOS, Depression, Anxiety, Obesity",,"Bactrim, Tapazole, PTU, Poison Ivy/Oak","['Back pain', 'Fatigue', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 933689,NC,31.0,F,"Patient's reaction(s) noted during COVID vaccine observation period: Redness, swelling, or pain at the injection site, extending >2cm diameter area(no pain noted but area is itchy to patient.) area affected was directly around the injection site (left upper arm) spreading out about 2 inches around in all directions. Within about 5 minutes, area looks normal (no longer swollen or red) and was much less itchy for pt. Pt plans on going home.� Actions Taken: VS taken and WNL. Disposition: Patient declined ED visit",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,,,,,,"['Erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,PFIZER\BIONTECH,IM 933690,IN,42.0,F,"1st dose 12/19/20 Symptoms 12/20/20 headache, severe body and joint pain, fever 101.0, fatigue lasting about 24hrs. 2nd dose 1/9/21 Symptoms 1/10/21 extreme fatigue, body aches, fever 100.4 duration was approximately 24hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/10/2021,9.0,PVT,Emgality monthly injection,None,Migraines,"Influenza vaccines usually sick with fatigue,and bodyaches the following day",Norco,"['Arthralgia', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933692,AL,41.0,F,Mild soreness around injection site. Did not affect my daily activities.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,OTH,Levotyroxine 100ug,none,hypothyroidism,,none,['Injection site pain'],1,PFIZER\BIONTECH,SYR 933693,PA,57.0,F,"Pfizer-BioNTech COVID-19 Vaccine Headache, fatigue for 36 Hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Metformin HCL 500mg Duloxetine HCL DR 60 mg Buspirone HCL 15mg Gabapentin 300mg ProAir Inhaler Symbicort Inhaler,None,"Diabetes, asthma, obesity, depression, anxiety",,Scallops,"['Fatigue', 'Headache']",1,PFIZER\BIONTECH,IM 933694,,28.0,U,"About 45 minutes after receiving vaccine, I broke out into hives (minor) on the left shoulder/upper arm (surrounding injection site) and right forearm (more severe than left arm). Experienced slight drowsiness around 6pm into the rest of the evening. Currently taking two antihistamines at night (Xyzal and Hydroxizyne). Woke up the next morning (01/05) very drowsy and stayed in bed well into the afternoon. Drowsiness continued into Wednesday (01/06), but not as severe. Wednesday evening was when the drowsiness subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Somnolence', 'Urticaria']",UNK,PFIZER\BIONTECH, 933695,MD,24.0,F,"Hives on upper left arm; hives on upper right arm; hives on right forearm: onset over 24 hours after injection, lasts greater than 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,WRK,Tri-Femynor; Protonix 40mg,,,,"sulfa, tree nuts",['Urticaria'],1,PFIZER\BIONTECH,IM 933696,OH,59.0,F,"flushed face, fatigue, sore left arm into left chest area, muscles aches, swollen left arm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,diabetes,tetanus,,"['Chest pain', 'Fatigue', 'Flushing', 'Myalgia', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 933698,NC,47.0,F,"I was Covid positive back in August, so the day after getting vaccine i started having chills, fever, body aches, and broke out with small red flat bumps on my arms and left side.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,SEN,none,none,none,,none,"['Chills', 'Pain', 'Pyrexia', 'Rash', 'Rash erythematous']",1,MODERNA,IM 933699,TX,37.0,M,"On 12/17 tested positive for Covid results positive. After the vaccine exp tightness of chest, running fever. On 12/31 I went to ER was prescribed Prednisone/Inhaler. I went to PCP on 12/31 and 1/5 about my symptoms. I usually run 5 miles a day as of today can't run my daily routine. For some reason still exp shaking in my hands and tightness of chest not certain if this is from inhaler or steriods. I have a another appt scheduled with my PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/27/2020,1.0,PVT,No,Positive diagnosis to Covid,No,,No,"['Chest discomfort', 'Computerised tomogram thorax normal', 'Laboratory test', 'Loss of personal independence in daily activities', 'Pyrexia', 'Tremor']",1,MODERNA, 933701,IL,39.0,F,"Headache, joint pain, muscle aches and tiredness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Multi vitamin Vitamin D3 supplement,,,Soreness in arm that was injected,NKA,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH,IM 933702,TN,48.0,F,"Weakness, fatigue, fever to 101, chills, muscle aches, shivers, joint pain, severe headache, nausea, loss of appetite lasting approximately 72 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Premarin 0.9mg PO QD, occasional Excedrine Migrane for headaches, occasional sinus & allergy medications PRN & Kirkland's Acetaminophen rapid release during this reaction",none,none,,Latex- causing contact dermatitis,"['Arthralgia', 'Asthenia', 'Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 933703,IN,60.0,F,"I feel issue is more related to injection error, Injection site was above the deltoid. I have had steroid injections in other shoulder and this is the sensation I felt during injection. The rn also told me "" You have tough skin"" after the intense pressure started. I worked the night before injection. I went home to sleep. woke around 2pm with intense pain in my left arm, I could not shift position or move my arm. with out excruciating pain. I used heat, aleve, tylenol & biofreeze. By saturday, i could easily move left arm from elbow down, but extremely limited from shoulder. today i have most of my range of motion, but still have dull ache and pain restrictions. This pain is in my shoulder, not my arm or deltoid. . On thursday, pain was constant, roaring throb 7/10 shoulder to shoulder blade, almost to spine in back and down to elbow , then 9/10 with any movement. Today is ache 2/10 just in my shoulder, with 5/10 with some movement. I had to call into work 1/7. I am scheduled tonight. I am an ICU RN.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Injected limb mobility decreased', 'Pain', 'Pain in extremity', 'Sleep disorder']",1,MODERNA,IM 933704,GA,45.0,F,"Rapid heart rate, dizzy lightheaded, headache, large rash at injection site f/u at Urgent Care steroid prescription",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,PUB,Multivitamin,,,,"Penicillin, Ceftin","['Dizziness', 'Headache', 'Heart rate increased', 'Injection site rash']",1,MODERNA,IM 933705,,31.0,F,"body ache, chills, headache the next day after having vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Chills', 'Headache', 'Pain']",UNK,MODERNA, 933706,PA,38.0,F,"-Pt received vaccine at 7:25AM 1/8/2021 at Clinic. -No reaction immediately after the vaccine. -She was moved to the observation room. -After ~5 minutes, patent developed hives starting in the arm where vaccine was injected. -Rash continued to develop on both arms, chest, ears, cheeks. -Pt was very itchy on these areas, as well as her feet and inside of her ears. -Denied cough, difficulty breathing, itchy throat, watery eyes. -Patient was not in any respiratory distress. -Vitals were taken multiple times and were normal (see vitals section). -Patient was being closely observed by myself, PA-C. -Dr. was consulted and also evaluated patient. -We decided to treat with 25mg Benadryl IM (opposite arm of vaccination). -After Benadryl, pt was observed for another 15 minutes. -Rash & itching diminished significantly. -Vitals were taken again and were normal. -Pt was observed for total 1 hour 15 minutes. -Rash & itchiness diminished significantly after medication given. -Advised patient to take Benadryl PO in the afternoon or another antihistamine. -Will follow up with patient in a few hours via phone call & reevaluate in person if necessary. -ER precautions given: chest tightness, difficulty breathing, difficulty swallowing, itchy throat, feeling as if throat is closing, increased swelling, dizziness, loss of consciousness. -Pt will also return in 28 days for second dose of vaccine and will be closely monitored at this time. -Pt followed up with after a few hours and was feeling much better. Just sleepy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,-Valtrex 500mg -tramadol 50 mg -reglan 10 mg diclofenac 1% -baclofen 20mg,,"hx of kidney stone, genital herpes, cyst of thyroid, migraines.",,Shellfish - anaphylaxis Acetaminophen Amoxapine Aspirin Caffeine Iodine Penicillins,"['Injection site urticaria', 'Pruritus', 'Rash', 'Somnolence']",1,MODERNA,IM 933707,RI,56.0,F,"Pt entered observation @ 0840. This nurse asked pt if she felt okay @ 0850. Pt stated that her throat felt scratchy"". Water was offered. Asked pt how did she feel @ 0900, stated that s/s were still the same. This nurse administered Benadryl 25mg @ 0904. @ 0912 pt stated to this nurse that s/s were somewhat better. Pt remains in observation @ present time, time 0923. Still remains to voice s/s of distress @ 0933. States Benadryl 25mg did not alleviate the s/s. States s/s were worsening. Epi 0.3mg given @0934. Administered in L thigh. Pt sent to ER after administration of Epi 0.3mg. Pt alive and breathing @ 0947, when going into Registration @ ER, still continues to voice s/s of distress to throat.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,WRK,"Omeprazole 20mg QD , Lipitor 10mg QD, Aimovig 70ml, Venlaflexine 75mg QD",,"Migraine, Chiari Malformation",,"Bee Stings, NSAIDs","['Condition aggravated', 'Throat irritation']",2,PFIZER\BIONTECH,IM 933708,MA,63.0,F,"Fever, pain to site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"Metformin, Tylenol","Fever, pain to Vaccine site","Diabetes,",,,"['Injection site pain', 'Pyrexia']",1,MODERNA,IM 933709,VT,34.0,F,"I developed a headache about 1 hour after the vaccine was administered. Two hours later I developed a 100.4 temperature and malaise and body aches. The injection site was swollen, tender to touch and warm. The injection site area remained tender to touch and I was unable to lie on my left side to sleep for over 48 hours. I continued to feel foggy and fatigued for 48 hours. All symptoms have since resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Aviane- Oral Contraceptive 1 tab once daily Zyrtec 10mg 1 tab once daily Flonase Nasal Spray- 2 squirts in each nostril once daily Flovent Inhaler 1 puff once daily,None,Asthma,,NKDA,"['Body temperature increased', 'Fatigue', 'Feeling abnormal', 'Headache', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Malaise', 'Pain']",1,PFIZER\BIONTECH,IM 933711,TX,56.0,F,Chills beginning Friday night into early Saturday morning. Low grade temperature on Saturday of 99 at 10 am. Took Advil with relief. Sunday afternoon low grade temperature of 99 at 3 pm. Reports arm soreness bilateral.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,,,,,,"['Chills', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 933712,KS,38.0,F,"When I withdrew the needle from the patient's arm, 2 drops of the vaccine came out of the administration site and rolled down the patient's arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,PVT,,,,,,['Injection site extravasation'],1,MODERNA,IM 933713,FL,66.0,F,Headache occurred at 18 hr after dose Ibuprofen 400mg po every 8 hours Duration is 48 hr,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,Levothyroxine Liothyronine Acyclovir,,,,PCN,['Headache'],1,PFIZER\BIONTECH,IM 933714,,31.0,F,"Received second Pfizer covid vaccine. Felt extremely fatigue, joint pain, and pain in the injection site Friday night at work. Saturday night felt extremely fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Arthralgia', 'Fatigue', 'Injection site pain']",UNK,PFIZER\BIONTECH, 933716,LA,50.0,F,"About 12 minutes after injection, patient started to feel a hot feeling to her left upper arm (that is where she her injection was given); She denied having any other symptoms. Hx of shellfish allergy once years ago- face swelling. Has eaten it since and has not had any problem; She had slight pink discoloration to left arm inferior to injection spot; Area was warm to touch and felt ""hot to patient). Patient was treated with Zyrtec and her rash and hot feeling to arm resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Crestor 20 mg one po daily levothyroxine 88 mcg one po daily Ibupofen 800 mg one tablet three times a day prn,n/A,hypothyroidism hyperlipidemia,,none,"['Injection site rash', 'Injection site warmth']",1,MODERNA,IM 933717,CA,53.0,F,Body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/10/2021,1.0,UNK,,,,,,['Pain'],1,MODERNA,SYR 933718,NY,38.0,F,"Patient reports an area of redness and swelling on her right deltoid, which started the day after she received the first dose of her Maderna vaccine, on 12/31/2020. She also had pain in this area, but it resolved within 2 to 3 days. Her primary symptom is itchiness in the area. Denies any other symptoms, no body aches/fever/chills, no headache, no SOB, hives, or swelling of lips/tongue. She has not been reporting her symptoms to V-safe. No past medical history of vaccine reaction. No known allergies. Exam: R deltoid, 3 cm circular area of erythema, well-circumscribed, slightly raised, not particularly indurated. Warm to touch. Not tender to palpation. No evidence of ascending lymphangitis. No lymphadenopathy. Assessment: Localized reaction, no treatment provided, encouraged Pt to try cold compress & oral antihistamine for symptomatic relief",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,Synthroid,Thyroidectomy for thyroid CA,,,None,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 933719,IN,48.0,F,Fever 100.8 and sever aches.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Prilosec, HCTZ, and Synthroid",None,"Hypothyroidism, GERD",,NKA,"['Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933720,AL,61.0,F,"Euphoria began ~2hours after vaccine lasting ~2.5 hours. Unable to process information, irritability, anxiousness, generalized not feeling well around 5pm day of; went to bed. Woke up at 10:30pm with headache, took Tylenol. Wednesday didn't feel well in general, left work at noon, went home to bed. Thursday felt better but not baseline self. Friday generalized not feeling well. Saturday went to ER due to feeling much worse generally, SOB. Tests Urine, blood. Everything within normal limits.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,Tylenol prior to vaccine,None,Asthma Hypertension,,Reglan Benzoin,"['Anxiety', 'Blood test normal', 'Dyspnoea', 'Euphoric mood', 'Headache', 'Impaired work ability', 'Irritability', 'Malaise', 'Urine analysis normal']",UNK,PFIZER\BIONTECH, 933721,,37.0,M,"Patient completed COVID vaccine observation period with no issues. Then left observation area but returned a short time later complaints of rash on left shoulder/side. Pt took diphenhydramine 50mg by mouth prior to returning to observation area. Observed for an additional 30 minutes, pt declined ED evaluation and departed.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,WRK,,,,,,['Injection site rash'],1,PFIZER\BIONTECH,IM 933722,KS,43.0,F,NONE,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/09/2021,11.0,PVT,"LAMICTAL 150MG BID, PAXIL 20MG QD, LEVOTHYROXINE 0.25MG QD, METFORMIN 1000MG BID, INVOKANNA 300MG QD, VICTOZA 0.3MG SQ QD",,DIABETES TYPE 2,,BLUEBERRIES,['Unevaluable event'],1,MODERNA,IM 933723,FL,51.0,F,"I received the Moderna COVID-19 vaccine EUA and a few hours later started having chills, headache, weakness, fever and nauseas and stomach discomfort after Tylenol, My nose was congested but just the first night: Headache, and weakness Monday afternoon to Thursday afternoon, fever chills Monday afternoon to Wednesday afternoon, Nauseas an stomach problems disappear after my doctor prescribed Zofran and Pepto Bismol, Ibuprofen low the fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Cetirizine 10 mg, Montelukast SOD 10 mg",None,None,,"Pollen, dust, clams,","['Abdominal discomfort', 'Asthenia', 'Chills', 'Headache', 'Nasal congestion', 'Nausea', 'Pyrexia']",UNK,MODERNA,SYR 933724,MD,57.0,M,"Significant flu like symptoms that lasted for 36 hours from onset. Included a fever of over 101, sweats, chills and uncontrollable shivering. Had some numbness in fingers and toes. These symptoms were actually more severe that when I had Covid 19. Taking Tylenol would help ease the symptoms, I did rotate in a dose of Ibuprofen on a 2 hour interval one time during the worst of the symptoms. After the 36 hour mark the symptoms faded and I returned to a normal state, although very drained and fatigued. The severity of the symptoms seem like they would be dangerous for someone who is not in good health.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Topical steroidals for exzema.,"Had Covid 19 starting on 12/20/2020, 18 days prior to the vaccine.","None, other than eczema.",,"Latex, parabens","['Chills', 'Fatigue', 'Hyperhidrosis', 'Hypoaesthesia', 'Influenza like illness', 'Pyrexia']",1,MODERNA,IM 933725,AZ,77.0,M,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/01/2021,01/11/2021,10.0,PVT,"rasagiline,prmipexole,carbidope.donpezil.clonazepam,simavastatin,asprin,melaton,fludrocortisone carbidopa/levodopa sodium tablets",none,parkingtson heart disease,,none,['Unevaluable event'],UNK,PFIZER\BIONTECH, 933726,NY,41.0,F,"Jan 8, 2021 around 8pm, I felt cold and unwell but no fever. My left arm was sore. The following morning, I had fever of 101.4F. I also had bad headache and muscle aches. I tool 500 mg of Tylenol, had lots of fluids and rest for 2 days. Sunday when I woke up I felt better and I feel well now.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Vitamin C Multivitamins,None,None,,None,"['Headache', 'Malaise', 'Myalgia', 'Nasopharyngitis', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 933727,,56.0,F,Patient's reaction(s) noted during COVID vaccine observation period: lips tingling �Actions Taken: Vital signs taken and within normal for pt. Pt felt okay enough to leave �Disposition: Patient declined ED visit,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,WRK,,,,,,['Paraesthesia oral'],1,PFIZER\BIONTECH,IM 933728,NJ,53.0,F,On friday i woke up with strong body odor this is not usual for me I thought it was strange but went along with my day. Around 4 pm i started to feel a strange sensation on top of my right foot I had walked 2 dogs and i thought maybe i injured myself. By 7:30 I started to feel full like I wasn't breathing comfortably so i propped 2 pillows to help . After that i laid to watch a movie when on top of my right food i started to feel like something was traveling on top it just didnt feel right i ignored it but then my left foot and right foot started to have like a muscle spasm very painful my i started to shake felt confused and shaky speech took Ibuphrophen 400 mg everything started to subside fell asleep . Next day back to normal i didnt have pain in my legs no soreness.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/08/2021,3.0,OTH,vitamin c flaxseed maca,,no History of cervical cancer,,Red wine,"['Confusional state', 'Dysphonia', 'Dyspnoea', 'Muscle spasms', 'Pain in extremity', 'Sensory disturbance', 'Skin odour abnormal', 'Tremor']",2,MODERNA,IM 933729,IN,57.0,F,Fever up to 100.4 for three days. Chills for one day. Very sore arm for one day. Fatigue for one day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,"Duloxetine, Gabapentin, Advair, AirDuo RespiClick, Vitamin E, Florajen3, Apple Cider vinegar pill, multivitamin, calcium supplement.",COVID-19 symptoms started on 11/30/2020.,"Asthma, prior cervical cancer, prior breast cancer, prior melanoma",,"Celexa, Percocet, adhesives","['Chills', 'Fatigue', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 933732,PA,54.0,F,"On Day 11, I woke up with my arm again inflamed at injection site. Elevated, hot to touch. For 3 days after my Moderna shot my arm at injection site was hot, inflammed and sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/11/2021,11.0,PVT,"Multivitamin, Vitamin C, Lexapro, Xanax",None,"C5-6 neural foraminal narrowing, arthritis, bone spur",,None,"['Injection site inflammation', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 933733,NC,40.0,M,small itchy rashes on hands and feet and lasted about 5 days. reported event to the health department who instructed patient to see primary care physician. primary care physician recommended benadryl cream for itch and come back if not better within two days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PUB,"Losartan, sertraline, benadryl cream for itching rash",bronchitis,high blood pressure,,none known,"['Rash', 'Rash pruritic']",1,MODERNA,IM 933734,IN,,F,"Patient received her first COVID vaccine (Pfizer) on 1/4/21 at 1419. She called the clinic on Thursday 1/7 and reported ""Since her vaccine she has had body aches, fever, diarrhea."" Clinic staff referred her to her PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Diarrhoea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 933735,IN,49.0,F,"Fever, body aches, chills, headache, left lower quadrant pain front and back. Lasted 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,None,None,None,,None,"['Abdominal pain lower', 'Chills', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933736,TX,42.0,M,"chills, fever, cough, chest congestion, nasal congestion, HA, nausea, fatigue, body aches. Feel like I have the flu. Ibuprofen with mild improvement.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PVT,,,,,,"['Chills', 'Cough', 'Headache', 'Influenza like illness', 'Nasal congestion', 'Nausea', 'Pain', 'Pyrexia', 'Respiratory tract congestion']",2,PFIZER\BIONTECH,IM 933737,NY,54.0,F,"Cellulitis at Injection site. Have had similar reactions to insect bites. Hot to touch, swollen. radiated about 3 inches from center around. I ended up drawing a circle around area on Saturday (1/11); on Sunday I started the Moist Heat routine. This is what I have had to do done in the past for my adverse reactions to spider bites. Appears to be working...redness has faded, only now it looks like a ringed target--similar to what the pictures are for tick bites. Still warm to touch, but appears to be improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/06/2021,8.0,PVT,Allegra (for allergies) ; Advil as needed,,,,Have had several instances of cellulitis due to Insect Bites but have never been tested through an allergist.,"['Injection site cellulitis', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 933738,MD,39.0,F,"9 days after injection, large well demarcated 6cm diameter reddened circle around injection site. warm to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/11/2021,9.0,PVT,none,none,none,,none,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,IM 933739,OH,54.0,F,"Staff member checked on her at 3am and patient stated that she felt like she couldn't breathe. 911 was called and taken to the hospital. While in the ambulance, patient coded. Patient was given CPR and ""brought back"". Once at the hospital, patient was placed on a ventilator and efforts were made to contact the guardian for end of life decisions. Two EEGs were given to determine that patient had no brain activity. Guardian, made the decision to end all life saving measures. Patient was taken off the ventilator on 1/9/2021 and passed away at 1:30am on 1/10/2021. The initial indication from the ICU doctor was the patient had a mucus plug that she couldn't clear.",Yes,01/10/2021,Not Reported,Yes,1.0,Not Reported,N,01/08/2021,01/09/2021,1.0,OTH,"Aspirin, Diazepam, Doxepin HCL, Duloxetine, Juven POW, Lamotri Levothyroxin, Loratadine, Melatonin, Mucus Relief, Olanzapine, Prazosin HCL, Pregabalin,","Recent g-tube placement, Several hospitalizations over the pas few months due to low Oxygen Levels.","Major depression, borderline personality disorder, Cerebral Palsy, History of dissected left carotid artery",,Penicillin,"['Brain death', 'Bronchial secretion retention', 'Cardio-respiratory arrest', 'Death', 'Dyspnoea', 'Electroencephalogram abnormal', 'Intensive care', 'Mechanical ventilation', 'Resuscitation', 'SARS-CoV-2 test negative', 'Withdrawal of life support']",1,PFIZER\BIONTECH,IM 933740,TN,33.0,F,"fever of 105.6 15 hours from injection. Headache at a 10 of 10, chills, fatigue, shaking from fever, loss of bladder control due to uncontrollable shaking from fever, body aches. Fever up and down. Currently 48 hours out from vaccine and still overall not feeling well and currently febrile at 100.9",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,WRK,"synthroid, lisinopril, zinc, vitamin c, vitamin d3, slynd, setraline, propranalol",,"hashimotos, high blood pressure",,lamictal and latex,"['Chills', 'Fatigue', 'Headache', 'Malaise', 'Pain', 'Pyrexia', 'Tremor', 'Urinary incontinence']",2,PFIZER\BIONTECH,IM 933748,,43.0,F,"Itching and rash at injection site. Given IV Benadryl, solumedrol, Pepcid. Rash resolved after treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,"['Injection site pruritus', 'Injection site rash']",UNK,PFIZER\BIONTECH, 933750,FL,35.0,F,"Facial numbing, sore throat, dry throat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,unknown,unknown,unknown,,nka,"['Dry throat', 'Hypoaesthesia', 'Oropharyngeal pain']",1,MODERNA,IM 933751,PA,58.0,M,"Aprox 5 minutes after vaccine was given, patient stated he was not feeling well, asked for water and stated he was having trouble breathing. Was then assisted to clinic treatment room, vitals were taken: 08:45 B/P 171/110, HR 84, R 28 O2 97. EMS was activated. At 0900 158/94 HR 84 R 24 O2 97. Patient then voice he was having tightness in his throat. Epi Pen 0.3mg administered at 0900. At 0904 EMS arrived and patient taken to the nearest hospital.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/11/2021,01/11/2021,0.0,MIL,"Advair 500/50, Spriva 2.5mcg, Asmanex 220mcg, Metformin 100mcg, Nexium 20mg, Montelekast, Baby asprin 81 mg, Lovastatin, Nosonex, Pro Air, Duo Neb, Epi Pen 0.3 mg Busporine 150 Mg, Theophylin 400mg.",,,,"Shell Fish, Cologne, Perfume, Hand sanitizer, penicillin, Zpac, coconut, peanuts","['Dyspnoea', 'Malaise', 'Oxygen saturation normal', 'Throat tightness']",1,MODERNA,IM 933752,FL,89.0,M,"Severe neck and shoulder pain. Limited movement of arms, not able to put above the head.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/11/2021,3.0,PVT,Azor 5/20mg Hydrochlorothiazide 12.5 mg Atrovastin 10 mg Finasteride 5 mg Lomigan 0.01% Ocuvite Magnesium 25 mg Flaxseed oil 1200 mg Multi vitamin 1000 oil,None,High blood pressure,,None,"['Arthralgia', 'Joint range of motion decreased', 'Mobility decreased', 'Neck pain']",1,MODERNA,SYR 933754,NC,47.0,F,"Within 30 minutes of receiving vaccine on 12/31/20, I felt as if I had been given a ""sedative."" Within 2 hours of receiving, I developed severe hip pain. On 1/1/21, I felt ""drugged"" the entire day, with a severe headache. On 1/2/21, I had fatigue, and developed sever lower extremity pain during night. Severe fatigue continued through 1/4/21--I tested positive for Covid on 9/21/20--and I have struggled with lingering symptoms--fatigue, brain fog, and body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,MIL,"Zyrtec, Excedrin Migraine","Positive for Covid on 9-21-20, and have continued lingering side effects",History of Migraines,,Darvocet,"['Arthralgia', 'Condition aggravated', 'Fatigue', 'Feeling abnormal', 'Headache', 'Pain in extremity']",1,MODERNA,IM 933755,MD,26.0,F,"Numbness and tingling bil upper extremities, seizure, temporary paralysis R arm. Started day after vaccine given, was observed overnight in hospital.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,01/03/2021,01/04/2021,1.0,PVT,,,,,,"['Hypoaesthesia', 'Monoplegia', 'Paraesthesia', 'Seizure']",1,PFIZER\BIONTECH,IM 933756,NY,57.0,F,"developed progressively severe right flank pain and back pain on 1/1. Went to emergency department on 1/6/21 d/t severe pain (no fever, diarrhea, nausea or vomiting). ED md stated it was potentially shingles. Have had similar outbreak of shingles (no rash but severe right flank and abdominal pain approximately 12 years ago and was seen in same ED and the dx of shingles was made by the PA in Dr office). Pain improving as of today 1/11/21. Have been unable to tolerate the increased dose of the naproxen prescribed by the ED md d/t increased gastric irritation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,01/01/2021,10.0,PVT,"zyrtec 10 mg qd, rosuvastatin 10 mg qd , naproxen 200 mg bid, tylenol 500 mg qid prn, pepcid 20 mg bid, multivite qd, vit D3 1000 IU daily, valerian root at hs, turmeric 500 mg, tizandine 10 mg prn",none,"osteoarthritis, elevated cholesterol and triglycerides, NIDDM type 2",,"latex (anaphylaxis), doxycycline, bacitration, chocolate (ezcema), ascorbic acid (ezcema), tomatoes (ezcema), white faced hornets (anaphylaxis), environmental allergies (cats, mold, dust mites)","['Back pain', 'Computerised tomogram', 'Flank pain', 'Full blood count', 'Herpes zoster', 'Metabolic function test', 'Pain', 'Urine analysis']",UNK,MODERNA, 933757,NY,51.0,M,"feel like somebody hit me with a baseball bat, body ache low grade fever for 5 days",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Malaise', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 933758,VA,26.0,F,Body aches at 9:00am Chills at 9:00 am Headaches at 9:35 am Stuffy nose 11:00 am Fever of 100.5 at 1:00pm Last from 12/22/2020 - 12/24/2020,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,UNK,"Birth control, adderoll 5 mg",None,None,,"Shellfish, amoxicillin, penicillin","['Chills', 'Nasal congestion', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 933759,IN,39.0,M,Myalgias and chills for 20 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,UNK,None,None,None,,None,"['Chills', 'Myalgia']",2,PFIZER\BIONTECH,IM 933761,WI,45.0,F,"Woke up at 7am at 8:15am both of my eyes swelled almost shut instantly. Both were swollen above my eyebrow. Whites of eyes were still white. They didn't itch or hurt. Went to Urgent care and they recommended cold compresses, Loratadine, Vaseline. About 6 hours later the swelling went down, but not completely. Woke up Sunday morning and my eyelids were dry and scaly.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,None,Asthma Allergies Obstructive Sleep Apnea Syndrome Obesity Type 2 Diabetes - recently diagnosed,,Sulfa Drugs Hydromorphone Hcl Acetaminophen-Codeine Hydromorphone Chloroxylenol,"['Eye swelling', 'Eyelid skin dryness', 'Skin exfoliation']",2,PFIZER\BIONTECH,IM 933762,PA,26.0,F,"Redness, streaking and swelling of left arm. Diagnosed with cellulitis but not improving with Keflex. Prescribed prednisone, Benadryl and Pepcid with little improvement and seeing dermatologist today for further investigation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,,Asthma,Asthma,,,"['Cellulitis', 'Erythema', 'Peripheral swelling']",1,MODERNA,IM 933764,NJ,46.0,F,"Fever, chills, nausea, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,"Multivitamin, 81 mg ASA, Calcium, Vitamin D, Turmeric",none,none,,Naprosyn,"['Chills', 'Headache', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933765,CA,39.0,F,"I began experiencing all my covid symptoms. Chills, Fever, Cough, Nausea, Loss of Taste/Smell and Fatigue. This lasted for approximately two days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,"Levothyroxine, omeprazole, vitamin D",Covid-no positive test,,,No,"['Ageusia', 'Anosmia', 'Chills', 'Cough', 'Fatigue', 'Nausea', 'Pyrexia']",UNK,MODERNA, 933766,MT,41.0,F,"Patient given Moderna vaccine 1455. Patient reported feeling numb tongue, dizzy and nauseous. Patient took 25 mg diphenhydramine oral. Observed at vaccine clinic. began feeling more nausea. Tongue numbness not improving, took another 25 mg diphenhydramine. Patient sent to ED - taken by PALS/RN. Arrived in ED at 1600 complaining complaining of chest tightness with tingling in her throat. Out of concern that she may have progression to anaphylaxis so 0.3 mg of epinephrine was ordered intramuscularly. Patient also given 25 mg of Benadryl IV as well as Pepcid and Solu-Medrol. Patient was observed here in the emergency department for several hours. She did have some complain of some itchiness of her skin so additional 25 mg of Benadryl was given. She also was having some persistent chest tightness and appeared quite anxious and due to concern for anxiety is possibly a contributing factor, IV Valium was given for anxiolysis. On reevaluation, symptoms have improved significantly. She was counseled in regards to use of an EpiPen and a prescription was given for this. Prescription was also given per few days of prednisone and Pepcid. Provider recommended avoiding further covid19 vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,none,,,,"['Anxiety', 'Chest discomfort', 'Dizziness', 'Hypoaesthesia oral', 'Nausea', 'Pharyngeal paraesthesia', 'Pruritus']",1,MODERNA,SYR 933767,SC,55.0,F,"significant rigors, severe headache, felt feverish, but no fever for about 12 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,UNK,"Neium 40mg, OD; Xyzol 5mg, OD; D3, 2000IUs",None,Hx Hodgkins Lymphoma (in remision since 12/2003); bronchiectasis,,NKDA,"['Chills', 'Headache', 'Pyrexia']",UNK,PFIZER\BIONTECH, 933768,MI,34.0,M,After the 2nd vaccine exp fever of 102 by the evening it went away.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,No,No,No,,No,['Pyrexia'],2,PFIZER\BIONTECH,IM 933770,GA,39.0,F,Client reports with in minuets of being in the observation room her tongue started to tingle. Approached staff in hall and client and nurse went in to an exam room. Nurse started taking vitals and called Nurse Director and was instructed to administer 25ml IM of Diphenhydramine to right arm. Nurse cont. with taking vitals signs until client reported to feeling better.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PUB,none reported,Client reports history of Hyperthyroid,Client reports history of Hyperthyroid,,None reported,['Paraesthesia oral'],1,PFIZER\BIONTECH,IM 933771,NJ,39.0,F,"1/7- RECEIVED VACCINE AND REPORTED HAVING TINGLING TO LIPS (A FEW HOURS LATER), TOOK BENADRYL AND REPORTED THAT TINGLING WENT AWAY. 1/8- REPORTED TINGLING TO LEFT OUTERLIP AND AND WENT TO ER AND DIAGNOSED WITH BELL PALSY / FACIAL PARALYSIS AFTER EVALUATION",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Unknown,None,Cervicalgia ? DJD (degenerative joint disease) of cervical spine ? Obesity ? Paresthesia and pain of both upper extremities,,NKDA,"[""Bell's palsy"", 'Facial paralysis', 'Paraesthesia oral']",1,MODERNA,IM 933772,IN,42.0,F,"- muscle ache in upper arm and should within first half hour of shot - extreme body aches began that evening; continued throughout the day 1/10; still present morning of 1/11, not as intense - temperature spiked to almost 100 that evening; fluctuated throughout the next day",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,"Verapamil, Zoloft, Singular, Zinc, Vitamin D, Fish Oil, Methergine, One a day women","Tested positive for COVID 12/17/20, symptoms began 12/14/20. Tested negative 12/31/20. Residual symptoms continue to date.",migraines,,,"['Body temperature increased', 'Myalgia', 'Pain']",1,PFIZER\BIONTECH,SYR 933773,CA,61.0,F,Low grade fever body aches chills headache arm soreness,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/10/2021,2.0,UNK,,,,,,"['Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 933774,MO,88.0,M,"Sore shoulder, severe diarrhea. Went 19 times in 1 night.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,PVT,"Linsinopril, atrovastein, toprolxi and clonedine patch.",no,"high Bp, High choilesterol",,Possible Egg and Whole milk sensitivity.,"['Arthralgia', 'Diarrhoea']",1,MODERNA,SYR 933775,VA,57.0,F,"Pain in Left Arm, Headache, Body Aches, Joint Pain, Nausea all began the day after the injection which was a Tuesday; Friday night began chills and fever to 102.2 and nausea and vomiting increased leading to dehydration; Saturday night developed Cellulitis in Left Lower Leg",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Labetolol, Amlodipine, Spironolactone, Memantine, Ibruprofen, Aspirin, CBD",None,"Obesity, COPD, Lupus, Polyarthritis, Aortic Dissection, Hypertension",,"Vancomycin, Lisinopril, Dilaudid","['Arthralgia', 'Blood test', 'Cellulitis', 'Chills', 'Dehydration', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'Urine analysis', 'Vomiting']",1,MODERNA,IM 933776,OH,43.0,F,axillary lymphadenopathy in the same arm that I was vaccinated in,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,WRK,,none,,,,"['Lymphadenopathy', 'Mammogram', 'Ultrasound scan']",1,MODERNA,IM 933777,IN,32.0,M,"Fatigue, Headache, Bodyaches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Vitamin D3 Fish Oil Multivitamin,None,None,,None,"['Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH, 933778,MO,26.0,F,"Tiny pinpoint pimple looking raised bumps above elbows, shoulder, chest, and back of neck. Once discovered Benadryl 25mg was taken at 8:30 PM, and then a 2nd dose taken at 10:30 pm. Client then went to bed and did not wake up with bumps. Woke up feeling flu like symptoms Friday morning, nausea, muscle aches, headache, increased heart rate. Client does have history of migraines and anxiety which cause her heart to race. Sunday morning started with fever, cough, diarrhea, and runny nose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,Tramadol 50 mg taken @ 7 AM,,"Migraines, Endometriosis, & Interstitial cystitis",,None,"['Cough', 'Diarrhoea', 'Headache', 'Heart rate increased', 'Influenza like illness', 'Myalgia', 'Nausea', 'Pyrexia', 'Rash', 'Rhinorrhoea']",1,MODERNA,IM 933779,OH,35.0,M,"About 96-100 hours after administration, I had chills, palpitations, and soreness of my legs. The following day, I had mild fatigue, malaise, and temp of high 99's-100.6 F.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/09/2021,4.0,PVT,None,None,HTN. Hyperlipidemia.,,None,"['Body temperature increased', 'Chills', 'Fatigue', 'Malaise', 'Pain in extremity', 'Palpitations']",1,MODERNA,SC 933782,OH,61.0,F,"2 weeks after injection the area 2.5 x 1.5"" just below the injection site is red, puffy, itchy & raised. Up until now the only symptom was a sore arm the day after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/10/2021,12.0,PVT,Loratadine 10mg daily; Dicyclomine 20mg QID as needed for IBS symptoms,Irritable bowel symptoms on & off for about 1.5 yrs,irritable bowel symptoms being worked up.,,PCN; Tetracycline; Sulfa,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling']",1,MODERNA,IM 933783,IN,37.0,F,Lymphadenopathy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,,URI,,,,['Lymphadenopathy'],2,PFIZER\BIONTECH,IM 933784,TX,37.0,F,"Chills and low grade temp of 99.9 Friday evening. Reports extreme dry mouth, headache, and body aches. Motrin taken on Saturday and Sunday with improvement.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,,,,Experienced soreness and dry mouth with first dose,,"['Chills', 'Dry mouth', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933785,NC,69.0,F,a red rash approximately 2 inches by 2 inches developed over injection site. rash slightly raised and warm to touch with no pain. seems to be spreading after about 2 weeks,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PUB,"lisinopril, l arginine, flax oil",none,hbp,,none,"['Injection site rash', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Rash erythematous']",1,MODERNA,IM 933786,FL,,F,Same day after getting vaccine. I got really dizzy and my heart raced. Called the Paramedics over and suggested I go to hospital and I declined after speaking with cardiologist. Cardiologist advised I take a xanax. I went home after. Later that day I noticed a little swelling in my wrist. The swelling has Gradually increased to the left side in my wrists and both the backs of my legs. I called my cardiologist Dr and I am waiting for a cb. I spoke to Dr and he said it sounds like I am retaining water and advised me to up my diuretics'.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,UNK,"armour thyroid 120mg, aloprazalam 1mg, abilify 15mg, sertraline HCL 200 mg, norvasc 10mg, hydralazine 50mg, phernolactone 50, lipitor 40mg. metoprolol 100mg. butalbital Acetaminophen, ambien 10mg",no,"fibromyalgia, hypertension, High cholesterol, 2 times cancer survivor",,"zyfaxin, red ants","['Dizziness', 'Joint swelling', 'Palpitations', 'Peripheral swelling']",1,PFIZER\BIONTECH,SYR 933788,IL,34.0,F,Swollen and painful lymph nodes,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/09/2021,5.0,PVT,amlodipine besylate,,,,,"['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,SYR 933789,IA,50.0,F,Spasmodic torticollis,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,None,None,Degenerative arthritis,,None,['Torticollis'],1,MODERNA,IM 933791,IN,46.0,F,"exhaustion, lethargy",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Accupril, spirnolactone, metformin, lipitor, allegra, singulair, synthroid, vyvanse, dextroamphetamine, meloxicam ASA, MVI, Ca, MagOx",none,"HTN, hyperlipidemia, PCOS, ADD",,NKA,"['Fatigue', 'Lethargy']",2,PFIZER\BIONTECH,IM 933792,ME,33.0,F,"Manager was notified that the employee had suffered a stoke-like ""serious medical event"" hours after the end of her shift, while at home.",Not Reported,,Not Reported,Yes,,Not Reported,U,12/23/2020,01/01/2021,9.0,PVT,,,,,None,['Neurological symptom'],1,MODERNA,IM 933793,OH,51.0,M,"Numbness in right side of head and right arm (where he received injection). Starting getting confused. Legs started to give out. Continued working. Symptoms got worse. On and off paralysis of legs. Eyes flickered and darted. When he sat down at 1am, he took two nitroglycerin for chest pain. He asked a nurse to take his blood pressure. It was low. He felt he was losing control. He was struggling for breath. Eyes were tearing up real bad and tremors started. He stated he fought to stay conscious. Was started on oxygen. Was assisted in a wheelchair and taken to ER. Waited there for 4 hours. Was delusional. I left without being seen by a doctor after blood work and EKG. Went to sleep and woke up in river of sweat. Went to urgent care at that time. Was given a COVID test and it was negative. Was prescribed zinc and vitamins. He had the same symptoms like he did when he originally got COVID. Today at 9:36am, have fever off and on. Continues to feel pretty bad. Still dizzy.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,WRK,Metformin for diabetitis and blood pressure medications,No,"Prior COVID positive 4/2020, HTN, NIDDM",,No,"['Abnormal behaviour', 'Blood test', 'Chest pain', 'Condition aggravated', 'Confusional state', 'Delusion', 'Diplegia', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Eye movement disorder', 'Hyperhidrosis', 'Hypoaesthesia', 'Hypotension', 'Injection site hypoaesthesia', 'Lacrimation increased', 'Malaise', 'Muscular weakness', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tremor']",1,MODERNA,IM 933794,VA,54.0,F,"Shortness of breath, Fatigue, muscle aches, chest pain, dizzy and light headed, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,OTH,"Fish Oil, Vit D, Vyvanse",none,none,,Compazine,"['Chest pain', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH,IM 933795,DC,43.0,F,"Itchy, red, warm, slightly raised injection site on day 8 after vaccine. Symptoms resolved completely within 48 hours,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,PHM,"Vitamin D, Vitamin C, zinc, quercitin, melatonin, ashwaganda, b complex",None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 933796,IL,62.0,M,"Chills, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"Lasortan HCTZ, Vit. D, Fish Oil Pill, Men's One A Day Vitamin,",none,Non-Hodgkins Lymphoma,,none,"['Chills', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933797,IL,46.0,M,"The next day 1/10 headache, tiredness and injection site pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,None,None,None,,None,"['Fatigue', 'Headache', 'Injection site pain']",2,PFIZER\BIONTECH,IM 933798,MO,55.0,F,Red circular rash 8 days after injection. Description of rash: Perfectly round red rash aproximate size of a golf ball below the injection site. Rash is now encompassing the entire front of my upper left arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,"Calcium, D3, Areds2, Vitamin C w/Rosehips, B12 & Multivitamin",None,None,,PCN & Naprosyn,"['Injection site rash', 'Rash', 'Rash erythematous']",1,MODERNA,IM 933799,IN,56.0,M,"Arm soreness, severe muscle and joint pain, low grade fever, fatigue Treatment: Tylenol/ Motrin Outcome: symptoms better after 48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Tylenol/ Motrin,None,None,,None,"['Arthralgia', 'Fatigue', 'Myalgia', 'Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 933800,OK,53.0,F,metallic taste in mouth for a few hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,OTH,"Hydrochlorothiazide, Amlodipine",no,no,,no,['Dysgeusia'],1,MODERNA,IM 933801,UT,63.0,F,"large dark spot under lash line of lower eye, then 48 hours after small white bumps in dark spot.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"metformin, singulair, labetalol",,"asthma, type II diabetes, high BP",,macrobid,"['Dark circles under eyes', 'Rash macular']",UNK,PFIZER\BIONTECH, 933802,NY,31.0,F,The patient developed numbness in her left leg then shortly later numbness in her right arm affecting her balance and ability to walk accompanied by generalized weakness.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/10/2021,0.0,SEN,"B12, multi-vitamins",none,Peripheral Neuropathy,,none,"['Asthenia', 'Balance disorder', 'Gait disturbance', 'Hypoaesthesia']",1,PFIZER\BIONTECH,IM 933803,WI,23.0,F,"Pt received dose at 0828 and after about 15 minutes reported symptoms of: Face numbness, lip tingling, heart racing. A rash was also noted on her chest and perhaps to her right eye. Heart rate was 99 BPM and Pulse ox was 99%. Pt was transported to the ED for evaluation. Upon call back to ED they also stated pt reported her tongue was also affected (not swollen, but either numb or tingly).",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/11/2021,0.0,PVT,,,,,,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Palpitations', 'Paraesthesia oral', 'Rash']",1,PFIZER\BIONTECH,IM 933804,TX,29.0,F,"fever, chills, body aches, fatigue, muscle soreness, headache, enlarged/swollen lymph nodes on left side of neck",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,WRK,"Vyvance, zertec",none,none,,ceclor,"['Chills', 'Fatigue', 'Headache', 'Lymphadenopathy', 'Myalgia', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 933805,AL,66.0,F,"Patient had vaccine in Left arm. That same night patient had temp of 100.1 and the right neck at base of head to shoulder began to hurt patient was unable to swallow without pain in the next few days. Patient went to ER and was hospitalized for 2 days treated with IV steroids and 2 antibiotics (clindamycin and acyclovir). Patients symptoms resolved and patient was discharged without additional issues. The admitting physician was unable to identify the cause of these symptoms, but the vaccine could not be ruled out.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,12/16/2020,12/21/2020,5.0,WRK,,,,,,"['Arthralgia', 'Body temperature increased', 'Headache', 'Neck pain', 'Odynophagia']",1,PFIZER\BIONTECH,IM 933806,NH,29.0,F,"Patient was in the passenger seat with a male driver. Patient stated ""no"" when asked if any medical issues. Stated ""no"" when asked if had any adverse reactions in the past to vaccinations. Vaccine administered, pt within seconds lost consciousness. Few seconds later pt had a seizure. 911 called. Help called for pt to be moved to cot. Pt started coming to and feeling better. Male driver later stated something to the effect of ""this happens to her every time"". BP 110/60. HR 78. SPO2 96%",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,OTH,,,,,Ceclor,"['Loss of consciousness', 'Seizure']",UNK,MODERNA,IM 933808,VA,33.0,F,"Summary: syncopal event, hypotension, leukocytosis About 22-24 hours after receiving the first dose of the vaccine (1/8/21), the patient became nauseous and lightheaded, sat down in a chair for at least 30 minutes, felt worse and let a coworker know, then had a syncopal episode lasting 5-10 minutes, coworkers witnessed patient had stable vital signs but unresponsive, diaphoretic, pale, and shaking, a hospital rapid response was called (patient works at the hospital). Patient was taken to the ED for observation, remained hypotensive (90's/50's) for about an hour, then slowly returned to normal BP (110's/80's) over another hour. Patient likely did not require going to the ED, however was taken there as a precaution due initially to the length of time passed out and hypotension. Prior to this episode, the patient only experienced soreness at the injection site. Following this episode, the patient felt some weakness and had a mild headache for another 24 hours before returning to baseline.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,Levothyroxine 88 mcg PO daily Paroxetine 10 mg PO daily Norethindrone PO daily Post-natal vitamin with iron PO daily,"None (Of note, tested positive for covid-19 on 10/18/20, had mild symptoms)","Anemia Hashimoto's thyroiditis Anxiety/Depression Tested positive for covid-19 on 10/18/20, had mild symptoms",,None,"['Dizziness', 'Full blood count normal', 'Hyperhidrosis', 'Hypotension', 'Injection site pain', 'Leukocytosis', 'Loss of consciousness', 'Malaise', 'Metabolic function test', 'Nausea', 'Neutrophil count increased', 'Pallor', 'Pregnancy test negative', 'Syncope', 'Tremor', 'Urine analysis normal', 'White blood cell count increased']",1,MODERNA,IM 933809,GA,39.0,F,"Client approached a Nurse in the hall, reports within min. of being in the observation room client reports a ""tingling tongue"". Client was lead to an exam room and vitals were taken at 12:44pm. Lead Nurse called Nursing Director and was instructed to administer IM 25ml of Diphenhydramine to right arm. Vitals were continued every 5 min. Client reported ""feeling better"" and after aprox. 30min left to go home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PUB,None reported,HX of Hypothyroid,HX of Hypothyroid,,none reported,['Paraesthesia oral'],1,PFIZER\BIONTECH,IM 933810,IN,33.0,F,"Redness at site of injection, pain at site of injection, fever/chills, joint aches",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PUB,"Concerta, Spironolactone, xyzal, Sudafed, Flonase",None,Osteopetrosis,,Betadine allergy; seasonal outdoor allergies,"['Arthralgia', 'Chills', 'Injection site erythema', 'Injection site pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933811,IN,33.0,F,"On Sunday 12/20 I started to get a significant sharp headache on the left side that radiated down my left neck and arm to the point of injection site. My left arm was also sore as to be expected with typical injection but this sensation was different. It caused a sharp neuromuscular pain that was also itchy/burning. Extended in the region of sternocleidomastoid site. No rash development but seemed like symptoms of shingles. Continued through until approx 12/26/20. Improved with heat pack, Tylenol and Motrin. Was evacuated by physician on 12/21/20 with no testing or medication provided as symptoms were unclear.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/20/2020,2.0,PVT,Zoloft 75 mg,None known,Post Partum anxiety/ocd,,None known,"['Headache', 'Neuromuscular pain', 'Pain in extremity', 'Pruritus', 'Skin burning sensation']",1,PFIZER\BIONTECH,IM 933812,AZ,31.0,F,"day 1 fatigue, sore arm day 2 more fatigue, extra sore arm, head ache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 933813,TX,31.0,F,Big red welps all over upper arm where vaccine was given. Has been there for 2 weeks now.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,PVT,None,None,None,,None,"['Injection site erythema', 'Urticaria']",1,MODERNA,IM 933814,UT,26.0,F,I am currently 20 weeks pregnant. y left arm was really sore after the injection. I had pain under my left armpit with fever and chills and felt fatigued. My symptoms lasted two days. I slept a lot during the day and day after the injection . I did not get care from a hospital or doctor.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,WRK,"Wellbutrin 150mg OD (extended release), Prozac 40mg OD",I had a cold one prior to vaccination.,Depression and anxiety,,None reported,"['Axillary pain', 'Chills', 'Fatigue', 'Hypersomnia', 'Injection site pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 933815,IL,37.0,F,"Left axillary lymphedema started at slight discomfort on 1/8/2021 and has progressively worsened over the weekend to increased swelling and pain, no treatment, ongoing condition",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/08/2021,4.0,PVT,Effexor,none,none,,chlorahexadine,"['Axillary pain', 'Discomfort', 'Lymphadenopathy', 'Lymphoedema']",1,MODERNA,IM 933816,NH,36.0,F,red blotchy area on my arm near the injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/08/2021,10.0,PVT,multi vitamin,none,none,,"kiwi, mango","['Injection site reaction', 'Rash macular']",1,MODERNA,IM 933817,IN,40.0,F,"Started out with my shoulder blades being sore that night. I woke up the next morning and was sore all over, my head hurt, and my temperature was anywhere from 100.3-101. I checked it various times thru out the day. By the time I was ready for bed I felt a little better, but not up to normal standards. I slept thru the night and woke up fine. I wasn't sore anymore and my twmp was 98.2.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,UNK,Singulair & Flonase,,Have been diagnosed with chronic sinusitis,,"Tomatoes, onions, & sugar beets","['Arthralgia', 'Body temperature decreased', 'Body temperature increased', 'Headache', 'Pain']",2,PFIZER\BIONTECH,SYR 933818,NC,41.0,F,I experienced hives approximately one week after having the vaccination. I have pictures of the hives. They initially started around the site of the vaccination and then spread to other places on my body. I am continuing to experience multiple hives on various places on my body.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,PUB,"Adderall, oral birth control (Blisovi FE), Lysine supplement",None known,Asthma,,No allergies that I am aware of,"['Injection site urticaria', 'Urticaria']",1,MODERNA,SYR 933819,MD,52.0,F,"Employee c/o dizziness, high blood pressure and nausea immediately after injection. Employee vomited and was assessed by MD. Per MD on-site at clinic, the patient's BP was ""elevated but WNL."" Received water and was monitored for an additional 45 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,,,Diabetes Type 2,,,"['Blood pressure increased', 'Dizziness', 'Immediate post-injection reaction', 'Nausea', 'Vomiting']",1,MODERNA,IM 933820,LA,47.0,F,"Employee had no adverse reaction. Staff told me that we need to complete this form about event. 1/4/21 Patient got injection with Agency, consent she completed stated she had never received a covid vaccine of any type. When I went to enter into database it showed she got one 12/30 at the Hospital. I called her Immediately and she told me she had filled out the consent at Hospital but injections were not ready when she got off night shift so she left and did not get it. By Wednesday her story changed to she got it there and at Agency.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Inappropriate schedule of product administration', 'No adverse event']",1,MODERNA,IM 933821,IN,82.0,M,"Had a slight fever, chills, aching muscles and joints and slight shortness of breath.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,UNK,"hydrochlorothiazide, aspirin, atorvastatin, losartan. Plavix, Tamsulosin, metoprolol, fluorometholone",,"hypertension, history of stroke, heart valve replacement, and pacemaker",,"scallops, sulfa","['Arthralgia', 'Chills', 'Dyspnoea', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 933822,NH,32.0,F,At 3:30 p.m. the patient turned flush and red on neck and upper chest area. Pt waited in observation area for 30 minutes to monitor allergic response. pt was administered 50 mg diphenhydramine and recovered and left clinic at approximately 3:55p.m.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PUB,,,,,,"['Erythema', 'Flushing']",UNK,MODERNA,IM 933823,TX,45.0,F,"First dose of vaccine was received on 12/22/2020. Became COVID test positive on 12/30/2020. Had bodyaches, sore throat on 12/29/2020. Symptoms improved in 4 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/29/2020,7.0,PVT,Levothyroxine,None,Hypothyroidism,,None,"['COVID-19', 'Oropharyngeal pain', 'Pain', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,IM 933824,,60.0,F,"fatigue, chills started about 8 hours after the vaccine; went to bed early and by 24 hrs the reactions had gone away. No pain at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/11/2021,3.0,PVT,"Vitamin B12 (prescription strength), OTC Tylenol when needed",None,None except for osteoarthritics (marfans) and some anemia,,"Sensitivity to penicillan, history of bleeding ulcer, allergy to bananas","['Chills', 'Fatigue']",1,PFIZER\BIONTECH,IM 933825,SC,55.0,F,"significant rigors, severe headache, felt feverish, but no fever for about 12 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Nexium 40 mg, OD; Xyzon 5mg, OD; D3, 2000IUs, OD",,Hx Hodgkins Lymphoma (remission 12/2003) Bronchiectasis,,NKA,"['Chills', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH,IM 933826,KY,49.0,M,Fever headache nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,Synthroid Phentermine,None,Renal disease,,None,"['Headache', 'Nausea', 'Pyrexia']",UNK,PFIZER\BIONTECH, 933827,PA,25.0,F,"Swollen, red, painful about 2in in diameter for over 24 hours: fever of over 100.1, nauseous, severe body aches and muscle pain, migraine, fatigue, body chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,WRK,,,,,,"['Chills', 'Fatigue', 'Injection site erythema', 'Injection site swelling', 'Migraine', 'Myalgia', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 933828,VA,39.0,F,"My upper arm where the injection was administered, started to radiate pain up to my neck. I noticed at that time a painful lump at the front base of neck, right side. The pain started to increase throughout the day. The following morning, the injection site was red and inflamed. The pain persisted throughout the day, radiating to my hand, all the way up to my neck. The injection site was swollen and red. On a scale of 1 - 10, my pain was at 8. The following day, the pain reached a 10, the swelling and inflammation had increased and I noted decreased muscle strength in my hand. This persisted throughout the night. It's now Monday morning, and with flexril, constant application of a heating pad, a topical Diclofenac gel, and twice daily dose of 800 mg of Motrin and 2 tyelnol over the course of the last 2 days, my pain is at a 7. The swelling has reduced at the injection site some, but the the redness has increased and so has the hardness of the site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/08/2021,6.0,OTH,None,None,None,,Ceclore,"['Grip strength decreased', 'Injection site erythema', 'Injection site induration', 'Injection site inflammation', 'Injection site pain', 'Injection site swelling', 'Neck mass', 'Neck pain', 'Pain', 'Pain in extremity']",1,MODERNA,SYR 933829,CO,62.0,F,"Eight hours after vaccine I developed terrible chills fever, terrible myalgia and weakness . The pain was terrible as was the fatigue and fever . I used Ibuprofen. 48 hours later I felt almost completely normal- no pain etc . Then 56 hours later resumption of chills fever for 4 hours . At 64 hours and after ibuprofen feeling better",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,none,none,none,,none,"['Asthenia', 'Chills', 'Fatigue', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933830,NC,56.0,F,"I noticed a runny nose for the entire first day and the next day I had an appointment. My right eye was puffy, swollen, red, itchy. I got a shot of dexamethazone and the next day I felt better. I also had a script for prednisone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,UNK,,,,,,"['Eye pruritus', 'Eye swelling', 'Ocular hyperaemia', 'Rhinorrhoea']",1,PFIZER\BIONTECH,IM 933831,NY,41.0,M,"patient started to feel very nauseous and had stomach cramps, went home early and took some OTC related medications to relieve symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/07/2021,2.0,WRK,Humira 40ml 2x/month,none,Crohn's Disease,,none,"['Abdominal pain upper', 'Nausea']",1,PFIZER\BIONTECH,IM 933832,IN,58.0,F,HANDS AND FINGER NUMBNESS AND TINGLING BEGAN APPROXIMATELY 2 HOURS AFTER RECEIVING VACCINE,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,"LIVALO, SYNTHROID, EMGALITY, METFORMIN, AMITRIPTYLINE, , CLARITIN, VITAMIN B 12, VITAMIN D, VITAMIN C, COQ 10, ZINC, PROBIOTIC, COLLAGEN",NONE,"HYPOTHYROIDISM, HIGH CHOLESTEROL, MIGRAINES, PRE DIABETES",,LATEX,"['Hypoaesthesia', 'Paraesthesia']",3,MODERNA,IM 933833,NY,27.0,F,"Fine for ~6-9 hours post injection. But then immediate fever (103F), body ache, extreme joint pain and a feeling of something eating away in my bones, chills, bruised/swollen/pain in left arm (injection spot), fever, fatigue, headache, light cough for 5 straight days. Not able to do normal activities. Took Tylenol and ice pack to alleviate fever. The day after injection, body fell so weak that my body acquired another viral infection (very unusual). No shortness of breath. Eating/drinking/appetite fine. No loss of taste/smell. I am exactly 1 week from the injection. No fever, just light headache. Able to resume normal activities but gets fatigued fairly quickly (after 3 hours). I am very active and work out 2 hours every day, but may not be able to do strenuous activity/exercise for some time... I was symptomatic covid last year in April 2019. This was very similar experience but an extremely debilitating, more intense version of the covid that I had. ***I am unsure if I should proceed with the second dose due to a very severe reaction to the first dose***",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Tumeric, Vitamin C, Glucosamine Chondroitin, birth control pills",None,None,,None,"['Arthralgia', 'Asthenia', 'Chills', 'Cough', 'Fatigue', 'Headache', 'Injection site bruising', 'Injection site pain', 'Injection site swelling', 'Pain', 'Pyrexia', 'Viral infection']",1,PFIZER\BIONTECH,IM 933835,MI,89.0,F,"Injection site red, warm, swollen, painful. 6 cm x 11 cm in size",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/09/2021,2.0,SEN,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 933836,FL,38.0,F,"chest tightness, trouble breathing, dizziness and blurry vision",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,Lexapro 10mg po qd,none,none,,nka,"['Chest discomfort', 'Dizziness', 'Dyspnoea', 'Vision blurred']",UNK,PFIZER\BIONTECH, 933837,TX,66.0,F,"After several hours, patient describes pain, numbness and cramping down left arm, muscle spasms causing fingers to curl, shortly thereafter generalized muscle aches and fever up to 101. 3 days later rash which has now been identified, with PCP, as herpes zoster. She has no known history of shingles in the past.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PHM,Thyroid since 1 capsule daily Energy vitality support 1 capsule daily Bone strength 1 tablet daily Vitamin D 5000 units daily Vitamin C 1000 mg twice daily Gingerroot 550 mg 1 capsule with breakfast. All supplements,"None. Patient also reports no history of COVID-19, gets checked with rapid test regularly as works - Long term care provider",Hypothyroidism,,Penicillin,"['Extremity contracture', 'Herpes zoster', 'Hypoaesthesia', 'Muscle spasms', 'Myalgia', 'Pain in extremity', 'Pyrexia', 'Rash', 'SARS-CoV-2 test negative']",1,MODERNA, 933838,TX,32.0,M,"Moderna COVID-19 Vaccine EAU Approximately 12hrs (10pm) after receiving the first dose I had severe, uncontrollable chills, severe headache, & nausea. The chills lasted throughout the night and were gone by the next morning. The headache & nausea continued for the next day and half but were less severe than the initial reaction. In addition I felt lethargic for about 2 days after the chills stopped.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,15mg Lexapro 20mg Atorvastatin,,,,,"['Chills', 'Headache', 'Lethargy', 'Nausea']",1,MODERNA,IM 933839,NY,82.0,F,"Severe lower back pain, seems like muscle spasms. Cannot rise from sitting position without severe back pain. Standing, sitting, lying down is pain free unless I try to change position.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/01/2021,01/09/2021,8.0,UNK,"simvastatin, low dose aspirin, lexapro",none,none,,none,['Back pain'],UNK,MODERNA,SYR 933840,MD,61.0,F,"Waited at the vaccine location 30 minutes and felt fine, driving home started to feel tingling and numbness on lips, face, face was puffy, mouth was dry, hard to swallow. Went to Medical Center as it was closest to home. This was about 1 hour after the shot was received. My chest was feeling tight when I arrived at the hospital and started with a slight headache.They checked my vitals BP was 146/91, pulse was 107, SPO2 was 98, temperature was 97.9. They gave me 2 Benadryl pills and had me stay in a room. After a few hours my vitals returned to normal and I was feeling better. They kept me a few more hours to make sure the symptoms did not return. I was discharged with a prescription for benadryl and zyrtec to take as needed. Only took the Benadryl that evening and the next morning with Tylenol. My arm was sore the next day but felt fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,WRK,"Entresto, Metoprolol Succ Er, Rosuvastatin, Ibuprofen, Vitamin C & Vitamin D",None,Heart Failure,"Have gotten sick with Fever, Chills, Aches, Fatigue with the Flu shot in 2014 & 2015 for multiple days. Stopped getting the Flu ","Sulfa Drugs, Flu Shot","['Chest discomfort', 'Dry mouth', 'Dysphagia', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Pain in extremity', 'Paraesthesia', 'Paraesthesia oral', 'Swelling face']",1,MODERNA,SYR 933841,NC,55.0,F,"Shortly after administration of the vaccine on 1/7/21, the patient experienced heart palpitations. Continued all day and into the next day. The patient contacted PCP on 1/8/21. PCP indicated since a recent stress test was done (12/1/20), no need for an EKG. Per patient, PCP thinks the patient has acid reflux (actively taking omeprazole 20mg/day). Palpitations have resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Metoprolol 25mg daily, Omeprazole 20mg PO daily, Atorvastatin 10mg PO QHS, Flonase 1 spray each nostril BID",None known,"Hyperlipidemia, HBP",,"Vitamin C, elderberry, vitamin D, vitamin C","['Cardiac stress test', 'Palpitations']",1,PFIZER\BIONTECH,IM 933842,NH,31.0,F,"Faint rash at lower anterior neck, experienced 5 minutes after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,OTH,,,,,,['Rash'],1,MODERNA,IM 933843,,65.0,F,"Patient stated she felt ""funny"" ~10 minutes after vaccination, felt ""cold in chest and waves of tingling"", initially diaphoretic with BP 175/110, HR 110. AFter 15 minutes patient stated she felt better but noted vision was still slightly blurry. After 45 minutes vitals were BP 175/90, HR 88 with ongoing periods of blurry vision and tingling in extremities.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Albuterol inhaler, prednisone inhaler (?), fexofenadine",,,,"Chlorhexidine, bactiracin, duloxetine, latex, levothyroxine, melatonin, penicillins, phenylephrine, sulfa, wheat, hazelnut, fish","['Feeling abnormal', 'Feeling cold', 'Hyperhidrosis', 'Paraesthesia', 'Vision blurred']",1,MODERNA,IM 933844,TX,43.0,F,"Axillary swelling, pain and tenderness in armpit. pain in finger joints.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/10/2021,2.0,PVT,none,none,none,,none,"['Arthralgia', 'Axillary pain', 'Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 933845,CO,56.0,F,"After I got the 1st dose, I had a headache and then 2 days after I had a migraine and was puking. I was dizzy and went to ER 5 days after dose. I was sick for 7 days. I puked for 5 and stayed in bed, I could not get out of bed. I could not hold any food or fluids for 5 days, I never felt like this before. I missed 3 days of work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/06/2021,5.0,PHM,Benedryl Nexium,Diabetes II Degenerative Disc & Joint Decease GERD Spinal Stenosis,Diabetes II GERD Degenerative Disc & Joint Decease,,,"['Dizziness', 'Headache', 'Impaired work ability', 'Malaise', 'Migraine', 'Vomiting']",1,MODERNA,IM 933846,WV,91.0,F,"1-2-2021 10:30 PM Complained Right arm/back hurt - took Tylenol 1-3-2021 Complained Right arm hurt, dizzy 1-4-2021 Felt better - did laundry, daughter found her deceased at 3:30 pm. Dr. at hospital said it was ""cardiac event"" according to death certificate.",Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PUB,NONE,MACULAR DEGENERATION 10 YEARS OR MORE,NONE,,NKDA,"['Back pain', 'Cardiac disorder', 'Death', 'Dizziness', 'Pain in extremity']",1,MODERNA,IM 933847,ME,45.0,F,"While sitting upright I became dizzy. I was assisted to my bed room and remained dizzy throught. While laying down I was dizzy. I took some tylenol pm and went to sleep. When awakening, I was not dizzy. Occasionally on day two and three, I feel like its going to start again but it has not.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,Levothyroxine Pantazaprole,None,Hypothyroidism gerd,Redness at injection site after a tetanus vaccine,Nka,"['Dizziness', 'Somnolence']",2,PFIZER\BIONTECH,IM 933848,TX,61.0,F,Extreme fatigue beginning on the evening of 1/7/2021 lasting through Saturday (1/9/2021) morning.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,,,,Similar reaction to first dose of COVID vaccine.,,['Fatigue'],2,PFIZER\BIONTECH,IM 933849,AZ,77.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/01/2021,01/11/2021,10.0,PVT,"amiopine,clopidogrel,eztimibe,insulin lispro,losatan,metrolo.pravastin,touieo,metformin",none,"diabetes, heart disease",,none,['Unevaluable event'],UNK,PFIZER\BIONTECH, 933850,,46.0,F,Developed cellulitis on arm. Being treated with 10 days of keflex. Redness and soreness to touch at area of injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/10/2021,10.0,UNK,,,,,,"['Cellulitis', 'Injection site erythema', 'Injection site pain']",UNK,MODERNA,IM 933852,MI,88.0,M,"Left deltoid red, warm, swollen at injection site. 6 cm x 7 c m",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/09/2021,2.0,SEN,,,,,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 933853,MI,38.0,M,"Patient received COVID-19 vaccine (1st dose) on 12-21-20. Sometime between 12-22-20 and 12-26-20 (received conflicting doses) patient noticed a rash on the torso. Rash not itchy or painful. Patient denied any tongue/lip swelling, no throat swelling, no dyspnea/dysphagia. Rash did not improve with Benadryl. Did get ok from Provider to receive COVID-19 on 1-11-21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/26/2020,5.0,PVT,"Fish Oil 1,000mg every day",,Hyperlipidemia,,NKDA,['Rash'],1,PFIZER\BIONTECH,IM 933854,PA,45.0,F,"Redness, warmth and swelling 2 days post injection. Seen in ED and prescribed doxycycline and improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,PVT,,,,,,"['Erythema', 'Feeling hot', 'Swelling']",1,PFIZER\BIONTECH,IM 933855,OH,56.0,F,A minor rash developed on the left side of my torso Friday night/Saturday morning. Appears to be resolving on its own. I felt fatigued all day Saturday (Feb. 9th),Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,PVT,no,no,Asthma / seasonal allergies,,seasonal allergies,"['Fatigue', 'Rash']",1,MODERNA,SYR 933856,MD,27.0,F,"swelling of lymph node in left side of neck, less than 48 hours after vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/08/2021,2.0,PVT,,,,,,['Lymphadenopathy'],1,PFIZER\BIONTECH,IM 933857,MO,28.0,F,"Chills, Muscle ache, Fatigue, Soreness at site of injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,UNK,None,None,None,,None,"['Chills', 'Fatigue', 'Injection site pain', 'Myalgia']",1,MODERNA,SYR 933858,MT,34.0,F,"fever, muscle aches, feels cruddy",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Feeling abnormal', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933859,ME,41.0,F,"The day of my vaccine and the following day my arm was very sore. It went away. 7-8 days after receiving my first dose my arm became sore at the injection site, warm to the touch and itchy. I just started today on the advice of my physician to take Tylenol, use cold compresses and Hydrocortisone cream. It's helping to take the edge off of the itch but my arm is still very warm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/10/2021,8.0,WRK,Citalopram HBR 10 MG,none,none,,"Amoxicillin, Sulfa drugs","['Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 933860,,44.0,F,"Significant redness, swelling and heat at injection site 1 week post injection. Approximately 5 inches extending from above the injection site, past it and toward the elbow. Some tenderness in upper arm and joint discomfort at elbow. No problems at injection site prior to onset of symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,PUB,metoprolol er succinate 50mg,,mild hypertension,,"food sensitivities to eggs, avocado and pineapple","['Injection site erythema', 'Injection site joint discomfort', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 933861,IL,60.0,F,"four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and increased fever continued thru the night and not able to sleep, very restless. The next morning after I had more weakness and major flair up with my MS, where I fell several times and was not able to get myself off the floor. Each time I fell it too approximately 20 minutes for me to get either in bed or a chair. Still had fever of a 100-101 through out the day, took ibuprofen to help, which it did for a short time but then fever was back. About 7pm I took some Benadryl and was finally able to fall asleep. The next morning, no fever but very weak. Went to health club to help with my legs. This day was ok, weak but improved. No falls",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,Levothyroxine Sodium 150 MCG Tabs Neupro 4 MG/24HR Pt24 Venlafaxine HCl ER 150 MG Cp24,none,Multiple Scelorsis,"fever, and weakness",Penicillins Sulfa antibiotics Lisinopril Copaxone Glatiramer Interferon Beta-1a,"['Asthenia', 'Condition aggravated', 'Diarrhoea', 'Fatigue', 'Multiple sclerosis relapse', 'Pyrexia', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 933862,IN,31.0,F,Woke up the next morning super weak and nauseous. Had little energy and no appetite. Slept most of the day. Friday (3 days after) felt tired and weak.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,None,None,None,,None,"['Asthenia', 'Decreased appetite', 'Fatigue', 'Nausea']",1,PFIZER\BIONTECH,SYR 933863,IN,52.0,F,Headache/Body Aches/chills/ fever of 100.9. Lasted approximately 6 hours. Symptoms were similar to when I had Covid.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,None,,,,"Sulfa, Bactrim, Tetracycline","['Chills', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 933864,,40.0,F,Cellulitis at injection site. Went to ED to get checked out. Also had severe vertigo.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/07/2021,7.0,PVT,,,,,,"['Injection site cellulitis', 'Vertigo']",UNK,MODERNA,IM 933865,IN,48.0,F,"Difficulty breathing, achy, joint pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,SEN,,,"rheumatoid arthritis, Asthma",,,"['Arthralgia', 'Dyspnoea', 'Pain']",1,MODERNA,IM 933866,IN,26.0,F,"10:00pm arm feels sore 11:00pm fever, lethargy 1:00am Chills, fever, muscle pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,"Trazadone, Lexapro",None,None,,None,"['Chills', 'Lethargy', 'Myalgia', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA, 933867,TX,39.0,F,"10 minutes later, minor headache and itching. 4 hours later, lightheadedness/dizziness. ~12 hours later (03:30 the next day) fever up to 102, skin felt on fire all over my body, gi cramps, mild intermittent cough, myalgias, fatigue, extreme headache behind my eyes, occiput, and jaw pain, rigors.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,"Nortrel, gabapentin",None,"Undiagnosed GI inflammatory conditions, chronic pain","Fluzone quadrivalent 10/2020, 39 years of age, hives, itching, welt at the injection site that increased in size over 2-3 days t","BuTrans patch, IV dilaudid, IV morphine","['Abdominal pain upper', 'Chills', 'Cough', 'Dizziness', 'Eye pain', 'Fatigue', 'Headache', 'Hot flush', 'Myalgia', 'Pain in jaw', 'Pruritus', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 933868,,42.0,F,"Employee who received the COVID vaccine on 12/29 woke up the next day with a slight headache and rash at her injection site. As the day went by, her headache worsened.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/30/2020,1.0,UNK,,,,,,"['Headache', 'Injection site rash']",1,MODERNA,IM 933869,,51.0,F,Cellulitis at injection site. Went to ED to get checked out. Also had severe vertigo.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/08/2021,8.0,PVT,,,,,,"['Injection site cellulitis', 'Vertigo']",UNK,MODERNA,IM 933870,FL,38.0,F,"Sore Left Arm, Fatigue Day 1 and 2, Day 3 Swelling and Redness of arms, face, and hives on chest ending in ER VISIT",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/1921,01/10/2021,36529.0,PVT,None,Acute Bronchitis (November 2020),Asthma Migraines,,Sulfa drugs,"['Blood test', 'Erythema', 'Fatigue', 'Pain in extremity', 'Peripheral swelling', 'Swelling face', 'Urticaria']",1,MODERNA,IM 933871,MT,47.0,F,"headache, body aches, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933872,MD,65.0,F,"I developed rigors with high fever 39.4 C. I was coughing, non-productive cough, pain at the base of my lungs from coughing, running nose, muscle pain, GI problems- vomited once and stool foul smelling, loose. I developed hematuria- visit to Patient first, placed on an antibiotic. Continued with high fever and shivers- went to Emergency Department, admitted. Started on cefuroxime- fever and symptoms subsided. Discharged home. One week at home- getting stronger by day. Back to work January 11, 2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/30/2020,8.0,WRK,Losartan 25 mg qd ASA 81 mg qd Synthroid 125 mcg qd x 6 days/week Crestor 10 mg qd.,CAD Hypothyroidism Seasonal allergies,CAD Hypothyroidism Moderate Sleep apnea Seasonal allergies Periodical UTIs,,Lipitor - muscle pain Ranozaline- lip and tongue swelling,"['Abnormal faeces', 'Chest X-ray normal', 'Chills', 'Computerised tomogram abdomen', 'Computerised tomogram thorax', 'Cough', 'Culture urine', 'Diarrhoea', 'Gastrointestinal disorder', 'Haematology test normal', 'Haematuria', 'Laboratory test normal', 'Myalgia', 'Pulmonary pain', 'Pyrexia', 'Rhinorrhoea', 'Vomiting']",1,PFIZER\BIONTECH,IM 933873,NJ,38.0,F,"-Pt was given COVID19 Vaccine at 9:06AM 2/8/1982. -Immediately, pt felt tight in her chest. -Pt was taken into observation room by myself (PA-C). -She sat down and took off her mask and took a few deep breaths. -She said she had some tingling in her throat. -She coughed a few times. -After 1 minute and some deep breaths, she felt much better and the tightness & tingling went away. -Denied itchy & watery eyes, difficulty breathing, chest pain, itchiness, swelling, rash. -No rash or swelling was visualized. -Throat tinging subsided after 10 minutes. -Vitals were normal throughout entire encounter. -Pt was evaluated by myself and observed by myself for 30 minutes. -Pt was also evaluated by Dr. -Discharged after 30 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,-cephalexin 500mg -ibuprofen 800mg -medrol 4mg -erythromycin with ethanol 2% topical -fluticasone 50mcg spray,-currently breast feeding -Vitamin D deficiency,-anxiety,,-IV morphine -IV antibiotic (didn't know what type) -metrogel -Motrin in past,"['Chest discomfort', 'Cough', 'Pharyngeal paraesthesia']",1,MODERNA,IM 933874,MI,88.0,F,"Right arm red, warm, swollen, painful at the injection site. 7 cm x 6 cm.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/09/2021,2.0,SEN,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 933877,OH,50.0,F,Felt dizzy and nauseous and then passed out for 30-60 seconds. Vomited after I came to about 5 minutes after and have been fine since,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/02/2021,3.0,PVT,"Singular, Claritin, acyclovir, multivitamin",None,Asthma,,"Scopolamine, codeine, compazine","['Dizziness', 'Electrocardiogram normal', 'Laboratory test normal', 'Loss of consciousness', 'Nausea', 'Vomiting']",1,MODERNA,IM 933878,GA,28.0,F,"Both at time of first vaccine (12/19) and second vaccine (1/5) I had the same symptoms: headache, muscle and joint aches, malaise, fatigue, and pain at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,,,dermatomyositis,,sulfa drugs,"['Arthralgia', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Myalgia', 'Vaccine positive rechallenge']",1,PFIZER\BIONTECH,IM 933879,PR,37.0,F,"headache, chills, joint pain, nausea, swollen lymph nodes in right axillar area,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,none,none,none,,none,"['Arthralgia', 'Chills', 'Headache', 'Lymphadenopathy', 'Nausea']",2,PFIZER\BIONTECH,IM 933880,NY,58.0,M,"Taste of the vaccine in my mouth as soon as administered followed by full body flushing and sweating and hypersensitivity to sound and touch sense of depersonalization, anxiety Next morning, severe muscle and joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,,,,,,"['Anxiety', 'Arthralgia', 'Flushing', 'Hyperacusis', 'Hyperaesthesia', 'Hyperhidrosis', 'Myalgia', 'Taste disorder']",UNK,PFIZER\BIONTECH,IM 933881,MI,88.0,F,"7cmx 6 cm, red, warm, swollen, sore at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/09/2021,2.0,SEN,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 933882,KY,17.0,F,Moderna vaccine given to patient under the age of 18.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PUB,,,,,,['Product administered to patient of inappropriate age'],UNK,MODERNA,IM 933883,IN,45.0,F,"Received shot on 1/5/2021 at 9:30 am, at around 9:30 pm same day I started to get a headache. At 10:00 pm my headache was the worse headache I've had so I took 1 Ultracet and after 30 minutes of no relief I took a gabapentine. Still no relief and at 1:00 am I started vomiting uncontrollably and that last until around 4:00 am. I ran a low grade fever for the next 24 hours, highest fever was 100.1 but that was with taking Tylenol. I slept all day on the 1/6 and left every worn out and drained. 1/7 i stopped running a fever at 5:00 am started to feel better just tired. 1/8 I woke up feeling completely normal and fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"buPROPion 300 mg, Ultracet 37.5 mg-325 mg , Tirosint 137 mCg , hydrOXYzine hydrochloride 10 mg, meloxicam 15 mg , Allegra-D 12 Hour 60 mg-120 mg , Ozempic 0.5, Vitamin C","Sinus infection, UTI",Hypothyroidism,,Bactrim,"['Fatigue', 'Headache', 'Pyrexia', 'Vomiting']",1,MODERNA,SYR 933884,MT,27.0,F,"swelling redness at injection site, itching, muscle pain, not feeling well-all resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Injection site erythema', 'Injection site swelling', 'Malaise', 'Myalgia', 'Pruritus']",2,PFIZER\BIONTECH,IM 933886,PA,45.0,F,"Pain, redness and streaking, warmth at injection site, seen in ED and prescribed doxycycline.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,PVT,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site streaking', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 933887,IN,29.0,M,"Headache, chills, fatigue, light cough, general malaise. Symptoms lasted for about 36 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,OTH,"Wixela, one a day vitamins",COVID-19 in December,Allergy Induced Asthma,,Penicillin,"['Chills', 'Cough', 'Fatigue', 'Headache', 'Malaise']",2,PFIZER\BIONTECH,IM 933889,,55.0,F,"Patient experienced throat tightness, chest tightness, anxiety, and lightheadedness that did not subside after 30 minute observation. She was transferred to the ED for further evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,01/11/2021,0.0,UNK,,,,,,"['Anxiety', 'Chest discomfort', 'Dizziness', 'Throat tightness']",1,PFIZER\BIONTECH,IM 933890,MA,49.0,M,"Vaccine given at 07:50 (AM), with no immediate concerns. Within 4-6 hours, soreness at injection site was noted (soreness took 12-18 hours to start after first dose) By 8 hours after vaccination, had generalized ""tingling"" like a flu prodrome. By 12 hours after vaccination, experienced generalized aches, chills, mild headache and ipsilateral axillary lymphadenitis All symptoms persisted for 48 hours before resolution, except for axillary lymph node pain. Axillary lymphadenitis persisting , but resolving, by 72 hours after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Vitamin C OTC Omeprazole Fish oil,None,Cluster headaches/migraines,Dip/Tet: Sterile abscess of injection site (has occurred twice),None,"['Axillary pain', 'Chills', 'Headache', 'Injection site pain', 'Lymph node pain', 'Lymphadenitis', 'Pain', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 933892,CA,46.0,M,"Saturday all day my arm hurt. Sunday I woke up with no arm pain. Then after eating lunch I had diarrhea consistently and increased. Woke up in the middle of the night with more diarrhea and cold sweats. Temp 93.4. Sugar 112 in the middle of the night. I feel completely like trash, feel sick all over. Stomach hurts and lots of gas and diarrhea consistently.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,"Losartan, charvis, glimertain",unsure,hypertension and diabetic,,no,"['Abdominal pain upper', 'Cold sweat', 'Diarrhoea', 'Flatulence', 'Malaise', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 933893,MA,30.0,F,"patient reported symptoms from receiving the covid vaccine on 12/30/2020. On 1/6/2021 she indicated that she developed symptoms at the vaccination site such as circumscribed, indurated, and erythema area at the injection site. She notes some discomfort. Currently denies fever, SOB, or sore throat. Patient reports NKA and that she has never had a reaction to immunizations before. Patient also reports that her symptoms are improving and the area is starting to look better as of 1/8/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/06/2021,7.0,PVT,,None,,,NKA,"['Injection site discomfort', 'Injection site erythema', 'Injection site induration']",1,MODERNA,IM 933895,IN,43.0,F,"Temp 100.5, chills, body ache, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,"Zoloft, trazadone, multivitamin, zinc",None,Turners Syndrome,,NKA,"['Body temperature increased', 'Chills', 'Fatigue', 'Pain']",2,PFIZER\BIONTECH,IM 933896,,51.0,F,"On 12/29, employee began feeling a hard, cellulitisy spot on her right arm at the injection site. No pain, just a mild itch.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/22/2020,12/29/2020,7.0,UNK,,,,,,"['Injection site induration', 'Injection site pruritus']",1,MODERNA,IM 933897,MT,27.0,F,"swelling redness at injection site, itching, muscle pain, not feeling well-all resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Injection site erythema', 'Malaise', 'Myalgia', 'Swelling']",2,PFIZER\BIONTECH,IM 933900,,71.0,F,"Patient's reaction(s) noted during COVID vaccine observation period: Shortness of breath, throat tightness Actions Taken: Pt felt better within a few seconds. She thinks it was anxiety/panic attack after receiving her vaccine as the tightness/SOB only lasted a few seconds. She was walked by an RN from the vaccine administration area to observation area and took a set VS. VS were normal with a slightly elevated SBP. Pt stayed in observation area for a little longer to make sure she felt okay. Pt went home, declined ED visit",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,,,,,,"['Blood pressure increased', 'Dyspnoea', 'Throat tightness']",2,PFIZER\BIONTECH,IM 933901,CO,37.0,F,"For my first Pfizer shot I got fever of 102, chills, headache, muscle aches, malaise, weakness for 4 hours about 16 hours after shot. Following this, the headache and fatigue remained the rest of the day. Periodic headaches noted in the weeks following. After my second Pfizer Covid shot I experienced nausea, diarrhea, extreme fatigue and exhaustion, malaise 4 days are shot lasting about 24 hours in duration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/09/2021,3.0,PVT,None,None,None,,None,"['Asthenia', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia']",UNK,PFIZER\BIONTECH, 933902,NY,70.0,F,"Upper respiratory symptoms. Stuffy nose, severe chest congestion, cough, sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,"insulin, mobic, vit D, hctz, glipizide, pravastatin, citalopram, synthroid",upper respiratory infection,diabetes,,none,"['Cough', 'Nasal congestion', 'Oropharyngeal pain', 'Pulmonary congestion', 'Respiratory symptom']",1,MODERNA,IM 933903,NE,58.0,M,body aches x 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,none,none,none,,none,['Pain'],UNK,PFIZER\BIONTECH,IM 933904,TX,56.0,F,"SWOLLEN & SORE LYMPH NODE UNDER LEFT ARM PIT, NOTICED ON FRIDAY 1/8/21 THOUGH 1/10/21 AM. SWELLING STARTED TO DECREASE BY SUNDAY AFTERNOON 1/8/21, SWELLING DOWN BY SUNDAY NIGHT 1/8/21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/08/2021,2.0,PVT,Losartan Estradiol Vitamin D,,,FATIGUE,Relafen,"['Axillary pain', 'Lymphadenopathy']",2,PFIZER\BIONTECH,SYR 933905,NJ,48.0,M,"Headache , stomach discomfort and nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/07/2021,3.0,PVT,"High blood medication , Daily vitamins",NONE,NONE,,Seasonal allergies,"['Abdominal discomfort', 'Headache', 'Nausea']",UNK,MODERNA, 933906,KY,17.0,F,VACCINE GIVEN TO PATIENT UNDER THE AGE OF 18.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PUB,,,,,,['Product administered to patient of inappropriate age'],UNK,MODERNA,IM 933907,TX,52.0,F,"Itching to site 11 days after vaccine. Noted 10cm area of redness, warmth and swelling of the site in the evening of the 11th day. Took Zyrtec and applied steorid cream.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/09/2021,11.0,PHM,"propranolol, Protonix, Acyclovir, Zyrtec, Flonase, Fiber, Estradiol, Progesterone",none,HTN,,NKA,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 933908,MI,80.0,F,"Right deltoid sore, tender to touch with a large reddened area, area 11x8cm",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/09/2021,2.0,SEN,,,,,,"['Injection site erythema', 'Injection site pain']",1,MODERNA,IM 933909,NE,47.0,M,"1. Onset roughly 12 hours after injection lasting until approximately 32 hours after injection: fever, chills, body aches, nausea, sore left arm. Treated with 600 mg Ibuprofen every four hours. Fever would break and then come back. 2. Onset roughly 51 hours after injection lasting until approximately 55 hours after injection: fever, chills. Treated with 600 mg Ibuprofen. No symptoms since.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,,Mild asthma,,,"['Chills', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933910,NY,41.0,F,"pain on injection site, myalgia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/28/2020,1.0,PVT,multivitamins,none,none,,none,"['Injection site pain', 'Myalgia']",1,MODERNA,IM 933911,TX,39.0,F,Moderna COVID-19 vaccine EUA,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/11/2021,5.0,PHM,,,,,,['Unevaluable event'],2,MODERNA,IM 933912,KY,41.0,F,"On January 6, 2021, exactly one week after receiving my first dose of the Moderna vaccine, I woke up to my injection site being red, swollen, hot, and itchy. The area of redness has gotten bigger each day and is still hot and itchy with induration.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,WRK,None,None,None,,"Allergies to penicillin, amoxicillin, and bactrim.","['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 933913,IN,65.0,F,"Upon assessment resident noted to have increased respirations, lungs CTA. Resident c/o increased fatigue and muscle aches. VS 202/180, 118, 22, 97.1, 96%.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/07/2021,01/08/2021,1.0,SEN,Prescription 03/19/2019 - Open Ended metoprolol succinate tablet extended release 24 hr; 50 mg; amt: 50 mg; oral Special Instructions: Hold for SBP <100 or HR <60 Once A Day; Upon Rising Prescription 07/12/2019 - Open Ended Ampyra (dalfamp,,"Neuromuscular dysfunction of bladder, unspecified 02/26/2018 R13.13 Dysphagia, pharyngeal phase 03/06/2020 G35 Multiple sclerosis 02/26/2018 K58.9 Irritable bowel syndrome without diarrhea 02/26/2018 I50.9 Heart failure, unspecified 02/26/2018 K21.9 Gastro-esophageal reflux disease without esophagitis 02/26/2018 F33.1 Major depressive disorder, recurrent, moderate 03/18/2019 I10 Essential (primary) hypertension 02/26/2018 F41.1 Generalized anxiety disorder 02/26/2018 F39 Unspecified mood [affective] disorder 02/26/2018 H04.129 Dry eye syndrome of unspecified lacrimal gland 02/26/2018 G47.8 Other sleep disorders 04/04/2019 E87.5 Hyperkalemia 11/13/2018 M62.838 Other muscle spasm 02/26/2018 J30.9 Allergic rhinitis, unspecified 11/25/2019 R26.2 Difficulty in walking, not elsewhere classified 09/14/2018 E53.8 Deficiency of other specified B group vitamins 06/28/2018 E55.9 Vitamin D deficiency, unspecified 02/26/2018 E56.8 Deficiency of other vitamins 02/26/2018 R42 Dizziness and giddiness 02/26/2018 R52 Pain, unspecified 02/26/2018 R13.13 Dysphagia, pharyngeal phase (History of) 05/10/2019 R53.1 Weakness 09/14/2018 R26.81 Unsteadiness on feet 03/06/2020 R26.89 Other abnormalities of gait and mobility 03/06/2020 M62.81 Muscle weakness (generalized) 02/26/2018 Z51.89 Encounter for other specified aftercare 10/03/2018 Z86.16 Personal history of COVID-19 Note:June 2020 01/07/2021 R26.2 Difficulty in walking, not elsewhere classified 07/17/2020 R26.81 Unsteadiness on feet 07/17/2020 R26.89 Other abnormalities of gait and mobility 07/17/2020 G35 Multiple sclerosis",,"gabapentin, guaifenesin, Penicillins (PCN)","['Fatigue', 'Myalgia', 'Respiratory rate increased']",UNK,MODERNA,IM 933914,FL,35.0,F,Left side supraclavicular/infraclavicular/axillary lymph node enlargement starting on Saturday evening after Monday vaccination. By Sunday left arm soreness in area where vaccination was given. No pain in other arm or swelling in right side.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/09/2021,5.0,WRK,"Zoloft, Zyrtec, Famotadine, unisom, aldara",no,,,Sulfa,"['Injection site pain', 'Lymphadenopathy']",1,MODERNA,IM 933915,IN,31.0,F,received first dose of moderna vaccine; approximately 3 mins later feet became numb. Hands became numb. felt flushed. progressed into vago-vagal reaction; was instructed to lie down in bed provided in clinic. patient felt better after lying for 40 minutes and left clinic. Proceeded to work from home the rest of the day. Approxmiately two hours later felt throat tightening/swelling. resolved with benedryl.. Patient has had previous vaso-vagal reaction to all three doses of HPV vaccine series.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,vaso-vagal response to all three doses in HPV series; patient was 16,,"['Flushing', 'Hypoaesthesia', 'Pharyngeal swelling', 'Presyncope', 'Throat tightness']",1,MODERNA, 933916,CA,30.0,F,hives- like breaking out on fore head a lot of swelling in face numbness glands swollen under tongue,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/18/2020,12/24/2020,6.0,UNK,,,,,,"['Hypoaesthesia', 'Swelling face', 'Swollen tongue', 'Urticaria']",1,PFIZER\BIONTECH,SYR 933917,MI,80.0,F,"Right deltoid sore, tender to touch with a large reddened area, area 11x8cm",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/09/2021,2.0,SEN,,,,,,"['Injection site erythema', 'Injection site pain']",1,MODERNA,IM 933918,MN,65.0,F,"Pain in the left shoulder and left base of the neck. Patient received her COVID vaccine on 1/7/2021 in the left arm and developed the pain in her left upper shoulder the following morning on 1/8/2021 and continues through today (1/11/2021). Patient has not seen a provider or received treatment at this time, but will see her PCP today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,,,"Hypertension, diabetes, arthritis",,"Shellfish, sulfa drug, PPD preservatives","['Arthralgia', 'Neck pain']",UNK,PFIZER\BIONTECH,IM 933919,MT,26.0,F,"fever, headache, nausea, body aches, fatigue-symptoms resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933920,TX,86.0,F,"Itching at injection site and around, redness and hot to touch, 3-4 in redness around injection site, soreness for first few day after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,PVT,"IMBRUVICA, probiotic, Allura, Methenamine, Macrodantin",,Lymphoma,,"Codeine, talwin, cipro","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 933921,AZ,57.0,M,"MED STAFF INJECTED PATIENT, TISSUE FELT TIGHT, MED/SYRINGE GENTLY PRESSED INTO SKIN AND NEEDLE RETRACTED, POSS. LOSS OF VACCINE (UNKNOWN AMOUNT) NOTED. PT. LEFT ALERT/ORIENTED",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Muscle tightness', 'Product administered at inappropriate site']",1,PFIZER\BIONTECH,IM 933922,MN,33.0,F,"Patient was transferred to me at 2:04pm reporting that she had her COVID-19 vaccine at OTC op center with you around 11:30 today- About 1.5 hours later, around 1pm, she noted slight itching at the injection site that had progressed to a ?warm feeling? in her neck with hive type rash. She denied any breathing issues and reported having an allergy to strawberries, has rec?d vaccines in the past with no issues. She was on her way into town from home to get Benadryl and Zyrtec and was planning to stay in town to see if her symptoms resolved and stay by the clinic/hospital just in case. We called her back at 3:23pm and she reported feeling better-advised her to sign up for VSafe app., continue monitoring and f/u with ED if symptoms warranted. She gave you permission to submit reaction into VARES on her behalf.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PUB,None at this time,none that was known,none known,,Strawberries,"['Injection site pruritus', 'Rash', 'Skin warm', 'Urticaria']",1,MODERNA,IM 933923,IN,43.0,F,"Rash, fatigue, joint pain, low grade fever, chills, nausea, muscle pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,SEN,"Gabbapentin, montelukast, atorvastatin, flutisicone, hydrochloric acid (ear drops), claritin, lexapro,",none,"asthma, indoor outdoor allergies and menopause",,"aspirin, morphine, coconut, oysters, muscles, bacon","['Arthralgia', 'Chills', 'Fatigue', 'Myalgia', 'Nausea', 'Pyrexia', 'Rash']",1,MODERNA,SYR 933924,NY,22.0,F,"Rash on neck Hives on neck, chest and back",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,Omeprazole Librax Norgee (birth control) Topical tretinoin gel,"Tested positive for COVID19 on December 4th, 2020.",GERD,,,"['Rash', 'Urticaria']",1,PFIZER\BIONTECH,SYR 933925,PR,49.0,M,"5 days with fever. Headache, muscle pain, cough, trouble breathing, diarrhea, nausea, no appetite etc.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PUB,"Gatorade, Tylenol, aspirin",No,Polycythemia,,No,"['Cough', 'Decreased appetite', 'Diarrhoea', 'Dyspnoea', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,IM 933926,TX,52.0,F,"Left arm pit pain, left neck pain, intermittent left ear pain. Tolerable mild discomfort. No treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/08/2021,2.0,PVT,,,,,,"['Axillary pain', 'Ear pain', 'Neck pain']",2,PFIZER\BIONTECH,IM 933927,,59.0,F,"Localized swelling at COVID vaccine injection site, along with itching and rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/04/2021,7.0,UNK,,,,,,"['Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Swelling']",1,MODERNA,IM 933928,FL,68.0,F,"1 day after vaccine, chills, body aches, headache. 2 days later was feeling better but noticed lots of hair loss during shower. Noticed lots of hair on pillow, concerned with handfuls of hair loss.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,PUB,,,,,,"['Alopecia', 'Chills', 'Headache', 'Pain']",1,MODERNA,IM 933929,IA,89.0,F,"rash to arm, antibiotics started 1/10/21, rash area has extended slightly since 1/10/21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/10/2021,13.0,SEN,"Tylenol, Biofreeze, sinemet, chlorhexadine mouth wash, florinef, levothyroxine, melatonin, nitrofurantoin, prolia, refresh tears, senna","syncopal episode, intermittant/chronic","PARKINSON'S DISEASE (G20) 5/3/19 Principal Diagnosis (#67) Admission PERSONAL HISTORY OF (HEALED) OSTEOPOROSIS FRACTURE (Z87.310) 9/25/20 Other Diagnosis Admission T9, T10, T11, T12, lumbar vertebrae PERSONAL HISTORY OF (HEALED) TRAUMATIC FRACTURE (Z87.81) 9/25/20 Other Diagnosis During Stay left humerus-nondisplaced avulsion, pelvis MUSCLE WEAKNESS (GENERALIZED) (M62.81) 3/23/20 Other Diagnosis During Stay PAIN IN LEFT ELBOW (M25.522) 3/23/20 Other Diagnosis During Stay UNSPECIFIED LACK OF COORDINATION (R27.9) 3/23/20 Other Diagnosis During Stay NONDISPLACED FRACTURE (AVULSION) OF MEDIAL EPICONDYLE OF LEFT HUMERUS, SUBSEQUENT ENCOUNTER FOR FRACTURE WITH ROUTINE HEALING (S42.445D) 2/20/20 9/25/20 Other Diagnosis History REPEATED FALLS (R29.6) 12/11/19 Other Diagnosis During Stay URINARY TRACT INFECTION, SITE NOT SPECIFIED (N39.0) 10/29/19 9/24/20 Other Diagnosis During Stay ANXIETY DISORDER, UNSPECIFIED (F41.9) 10/9/19 Other Diagnosis During Stay ORTHOSTATIC HYPOTENSION (I95.1) 8/12/19 Other Diagnosis During Stay CHANGES IN SKIN TEXTURE (R23.4) 7/26/19 Other Diagnosis During Stay GENERALIZED EDEMA (R60.1) 7/26/19 Other Diagnosis During Stay OTHER ATHEROSCLEROSIS OF NATIVE ARTERIES OF EXTREMITIES, BILATERAL LEGS (I70.293) 7/26/19 Other Diagnosis During Stay TINEA UNGUIUM (B35.1) 7/26/19 Other Diagnosis During Stay DRY EYE SYNDROME OF BILATERAL LACRIMAL GLANDS (H04.123) 7/19/19 Other Diagnosis During Stay EXUDATIVE AGE-RELATED MACULAR DEGENERATION, LEFT EYE, WITH INACTIVE CHOROIDAL NEOVASCULARIZATION (H35.3222) 7/19/19 Other Diagnosis During Stay NONEXUDATIVE AGE-RELATED MACULAR DEGENERATION, RIGHT EYE, INTERMEDIATE DRY STAGE (H35.3112) 7/19/19 Other Diagnosis During Stay PRESBYOPIA (H52.4) 7/19/19 Other Diagnosis During Stay PRESENCE OF INTRAOCULAR LENS (Z96.1) 7/19/19 Other Diagnosis During Stay DEMENTIA WITH LEWY BODIES (G31.83) 7/17/19 Other Diagnosis During Stay UNSPECIFIED DEMENTIA WITH BEHAVIORAL DISTURBANCE (F03.91) 5/9/19 9/24/20 Other Diagnosis History has dementia with lewy bodies AGE-RELATED OSTEOPOROSIS WITHOUT CURRENT PATHOLOGICAL FRACTURE (M81.0) 5/8/19 Other Diagnosis Admission FRACTURE OF OTHER PARTS OF PELVIS, SEQUELA (S32.89XS) 5/8/19 9/25/20 Other Diagnosis Admission chronic fractures of the right superior and inferior pubic rami OTHER FRACTURE OF UNSPECIFIED LUMBAR VERTEBRA, SEQUELA (S32.008S) 5/8/19 9/25/20 Other Diagnosis Admission WEDGE COMPRESSION FRACTURE OF T11-T12 VERTEBRA, SEQUELA (S22.080S) 5/8/19 9/25/20 Other Diagnosis Admission WEDGE COMPRESSION FRACTURE OF T9-T10 VERTEBRA, SEQUELA (S22.070S) 5/8/19 9/25/20 Other Diagnosis Admission CONTUSION OF LEFT HIP, INITIAL ENCOUNTER (S70.02XA) 5/3/19 9/24/20 Other Diagnosis History HYPERLIPIDEMIA, UNSPECIFIED (E78.5) 5/3/19 Other Diagnosis History HYPOTHYROIDISM, UNSPECIFIED (E03.9) 5/3/19 Other Diagnosis History WEAKNESS (R53.1) 5/3/19 Other Diagnosis History ANEMIA, UNSPECIFIED (D64.9)",,"Cephalexin, Cephalosporins, Sulfa Antibiotics",['Dermatitis acneiform'],1,MODERNA,IM 933930,AL,26.0,F,36 weeks pregnant as of 1/12/2021 left arm neuropathy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,10/12/2020,10/28/2020,16.0,PVT,,,,,,"['Exposure during pregnancy', 'Neuropathy peripheral']",1,PROTEIN SCIENCES CORPORATION,IM 933933,FL,57.0,M,Pain in the location of vaccine and increase temperature in the area. Pain was moderate and lasted 3 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,WRK,none,none,none,,none,"['Injection site pain', 'Injection site warmth']",1,MODERNA,IM 933934,NC,64.0,F,"blanchable erythematous pruritic rash to back, chest, abdomen occurring 1 week after vaccine and lasting a week at time of visit. Looks like hives but does not come and go. No resp concerns.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,Aspirin,none,none,,,"['Pallor', 'Rash', 'Rash erythematous', 'Rash pruritic', 'Urticaria']",1,MODERNA,IM 933935,MA,43.0,F,"Sever thrombocytopenia (platelet count 2,000) 8 days following Moderna COVID vaccine. Clinically suspicious for ITP.",Not Reported,,Yes,Yes,,Not Reported,N,01/02/2021,01/10/2021,8.0,PVT,Omeprazole,None,GERD,,NKDA,"['Haemoglobin normal', 'Immune thrombocytopenia', 'Platelet count decreased', 'Thrombocytopenia', 'White blood cell count normal']",1,MODERNA,IM 933936,AR,70.0,F,Stomach cramps/nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/11/2021,4.0,OTH,Vitamin D3,None,Osteoporosis,,NKA,"['Abdominal pain upper', 'Nausea']",1,PFIZER\BIONTECH,IM 933937,FL,73.0,M,"Moderna COVID-10 Vaccine EUA: Woke up on Jan 10 with injection site red, swollen (hard) and itchy. Less red on Jan 11, but still swollen and itchy. No obvious detrimental effect, but want to report the condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/10/2021,8.0,PVT,"Fenofibrate, losartan potassium, niacin ER, Levothyrozine, fish oil, multi vitamin, baby aspirin",None,None,,None,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 933938,PR,58.0,F,"Patient refers developed general malaise, headache, feverish, joint pain, nausea and left arm pain",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,WRK,None,None,None,,Allergy to Benadryl,"['Arthralgia', 'Headache', 'Malaise', 'Nausea', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933939,CO,50.0,F,severe headache-took Naprosyn and Maxalt with slight reduction in intensity but did not relieve-eased by 2nd day out from vaccine myalgias throughout both arms and legs-rest-eased by 2nd day out from vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Levothyroxine; Advil; Tylenol; NAPROSYN,,hypothryoid,,Flexeril,"['Headache', 'Myalgia']",2,PFIZER\BIONTECH,IM 933940,NY,49.0,F,"Swelling to B/L hands, itching and rash to right hand. Patient advised to use OTC antihistamine and follow up with PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,WRK,"Amlodipine, Timolol opthal, HCTZ",None,HTN,,"Seasonal, Pollen, Seafood","['Peripheral swelling', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 933941,NH,50.0,M,"One week following injection, 4 x 4 inch reddened rash area noted at injection site. Area was slightly raised and mildly itchy. Lasted about two days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/01/2021,4.0,PUB,None,None,None,,"Seasonal allergies, no known drug allergies","['Injection site reaction', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",1,MODERNA,IM 933942,NJ,38.0,F,"within minutes entire body numbness and ""hot"", followed by full body erythema. Was transported to the ED for treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,OTH,keppra,none,epilepsy,,none,"['Erectile dysfunction', 'Erythema', 'Feeling hot', 'Hypoaesthesia']",1,PFIZER\BIONTECH,IM 933943,MA,64.0,F,"approximately 12 hours after receiving, I felt like I was coming down with COVID again. Having just recovered last month, it felt like a recurrent nightmare. Shaking chills, slight temp, body aches, exhaustion. It lasted overnight and into the following day until approximately 3pm when I was able to get out of bed and drink water.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,"Blood pressure meds -Atenolol-Chlorthalidone 50mg, Rosuvastatin 20 mg.","On-set of COVID November 26, 2020. Sick for 2 weeks. December 11th feeling better.",none,,none,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",1,MODERNA,IM 933945,IL,32.0,F,"1/11 ""less than 24 hrs, work Sunday night, hands were red, right one swollen. Continued on and off at work when benadryl and chlortabs started wearing off. As night continued y face is a little swollen, headache, hypersensitive skin, sore tired""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/10/2021,0.0,PVT,,,,"12/18/20 Covid vaccine #1 Pfizer EK5730, age 32 the 1st 24 hours I was sore, the nextmorning I noticed my hands were red. Other",,"['Erythema', 'Fatigue', 'Headache', 'Hyperaesthesia', 'Pain', 'Peripheral swelling', 'Swelling face']",2,PFIZER\BIONTECH,IM 933947,VA,27.0,F,"Experienced fatigue and headaches beginning approximately 24 hours after vaccine injection. The fatigue and headaches were most severe on the between 24-33 hours after injection then gradually subsided until adverse events were eliminated on Day 3, approximately 57 hours post injection. No treatment was taken to lessen side effects, simply rest.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,MIL,Oral contraceptive (Vienva),none,none,"muscle soreness and extreme fatigue after the following vaccines were received on the same visit in April 2018: Meningococcal B,",none,"['Fatigue', 'Headache']",1,PFIZER\BIONTECH,IM 933948,TN,23.0,F,"Initially had a very sore arm day of, then on the second night my entire body became itchy and I had welts similar to those from allergy shots around my body and the itchyness has lessened however I am still itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/10/2021,2.0,SCH,"Allegra, Lo Loestrin Fe, Immune Defense 7 in 1 immune support, and vita fusion women's gummy vitamins",nothing,,,"Dust mites, tree pollens, grass pollens, and other seasonal allergies","['Pain in extremity', 'Pruritus', 'Urticaria']",1,MODERNA,SYR 933949,MT,59.0,F,"nausea in the head, fatigue, muscle soreness-resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Fatigue', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,IM 933950,DC,42.0,F,"Received vaccine on 1/5, began having swelling in bilateral hands and lower extremities on 1/7, along with fatigue. On 1/8 she reports new swelling started in her face (eyes and cheeks). Swelling has not improved today and fatigue has worsened.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/05/2021,01/07/2021,2.0,PVT,crestor nexium trazodone zanaflex synthroid,,Ulcerative Colitis Rheumatoid Arthritis,,mushrooms Humira Pen (site reaction) dextromethorphan erythromycin (nausea & vomitting) sulfaSALAzine (hives),"['Eye swelling', 'Fatigue', 'Peripheral swelling', 'Swelling face']",2,PFIZER\BIONTECH,IM 933951,NJ,31.0,F,"After 24 hours of receiving vaccine my lower back started to ache, I experienced body chills and my skin was sensitive to touch. This lasted for about 6 hours. I was also light headed and woozy for about 3 hours. The next morning all of these symptoms were gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,WRK,Zyrtec once a day and multi vitamin,None,None,,"Dairy sensitive, soy allergy","['Back pain', 'Chills', 'Dizziness', 'Tenderness']",UNK,PFIZER\BIONTECH, 933952,WI,38.0,F,"Felt and appeared flushed, as well as feeling her throat closing up and being ""unable to breathe"" within 6 hours of receiving the immunization",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,Allergies to dust and extreme cold,,"Sulfa, Allegra","['Dyspnoea', 'Flushing', 'Pharyngeal swelling']",1,PFIZER\BIONTECH,IM 933953,MD,36.0,F,"Starting 3 days after the vaccine (1/3/21) she had a severe headache. The next day she also had nausea and a mild cough. She was tested for COVID which was negative. She felt better by 1/5/21, but had muscle aches and fatigue on 1/7/21 and 1/9/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/03/2021,3.0,PVT,,,,,,"['Cough', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 933954,NE,49.0,F,"1/08/21 I was very fatigued, and a little bit of body aches. 01/09/21 I was very lethargic and had body aches, mostly in my joints",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Blood Pressure Medication,None,High Blood Pressure,,Morphine,"['Arthralgia', 'Fatigue', 'Lethargy', 'Pain']",2,PFIZER\BIONTECH,SYR 933955,MT,32.0,F,"I had a headache for about 48 hours after receiving the vaccine. Drinking water, taking ibuprofen and sleep id not help. I also had the typical sore arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,"prenatal vitamins, vitamin D, biotin, multivitamin",,,,Sulfa drugs,"['Headache', 'Pain in extremity']",UNK,MODERNA, 933957,WI,64.0,F,"As per RN documentation, Pt with hx of anaphylaxis with the 4th infusion dose of Rotuxin a couple years ago. PCP discussed benefit to prevent complications of COVID vaccine outweighs risk to get COVID vaccine. Discussed this as well with patient. She agrees to get the vaccine. � I stayed with the RN and patient for 30 minutes post vaccination and she had no symptoms other than BP and Pulse elevated further to 150s/90s. P upper 80s. She was transitioned to anther office with plan to continue observation for another 15 mins and recheck her BP. � About 45-50 mins post vaccine, she reported her lower arms and right side of her neck felt swollen but had no SOB or mouth swelling or itching. She was talking in normal sentences. Her face became more flushed as well as the posterior aspect of her forearms and she said the neck felt more swollen. Epi Pen was administered at 8:40 am and EMS was contacted. Her BP was 160/100, pulse ox 96%, RR 26, Pulse 88. � Transferred to ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/11/2021,0.0,OTH,"AsA 81 mg, Vit D3, Diclofenac gel, fluoxetine 20mg, meloxicam 7.5 mg, Multivit, rosuvastatin 20mg, spironolactone 100m, verapamil SR 180 mg",,"Sjogrens's Syndrome, Hyperlipidemia, HTN, NASH, depression, obesity, Carotid stenosis, PVCs, Diverticulitis, Osteoarthritis, sleep apnea, Chronic ITP, overactive bladder, elevated LFTs. Cervical radiculopathy.",RITUXIMAB - medication - infusion,"Ace Inhibitors, Lipitor, Sulfa, RITUXIMAB - anaphylaxis on fourth infusion dose. ( Used for ITP)","['Blood pressure increased', 'Flushing', 'Heart rate increased', 'Peripheral swelling', 'Swelling']",1,PFIZER\BIONTECH,IM 933958,,36.0,M,"Extreme body ache, chills, headache, vomiting, chest pain, difficulty breathing, sore throat. Tylenol & ibuprofen eased body ache, chills, headache but did nothing for chest pain, difficulty breathing, sore throat. So far, symptoms continue approximately 72 hours after receiving vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/09/2021,8.0,UNK,,,,,,"['Chest pain', 'Chills', 'Dyspnoea', 'Headache', 'Oropharyngeal pain', 'Pain', 'Vomiting']",1,PFIZER\BIONTECH,IM 933959,IN,37.0,F,100.4 fever Significant body aches Significant Fatigue Headache Joint Pain,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/10/2021,1.0,PVT,Wellbutrin XL Ambien,None,None,,PCN,"['Arthralgia', 'Fatigue', 'Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,IM 933960,NJ,62.0,M,"4 days after injection, redness and severe itching at site. Treating with warm compress and Benadryl cream.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/09/2021,5.0,UNK,"Vitamin D, Advair, Zyrtec","Sore arm for 2 days after injection, but passed easily",,,None,"['Injection site erythema', 'Injection site pruritus', 'Pain in extremity']",1,MODERNA,SYR 933961,NY,39.0,F,"Very sore for the first 3 days then the symptoms resolved and starting last Friday, my arm was red raised sore warm and tender to touch. Also had axillary tenderness and soreness down the bicep muscle as well",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/08/2021,9.0,PVT,None,None,None,,None,"['Erythema', 'Myalgia', 'Pain', 'Pain in extremity', 'Pain of skin', 'Peripheral swelling', 'Skin warm']",1,MODERNA,IM 933962,,29.0,F,"Fever, Body ache and injection site soreness. Took paracetamol - felt better.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,UNK,Multivitamins tablet,,,,,"['Injection site pain', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 933963,OK,60.0,F,"COVID vaccine #2 given Thursday January7th 12:30. Body aches and chills started Friday January 8th approx. 1700. Worsening symptoms through the night. Fever and slight cough on Saturday morning with body aches, joint pain and chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Blood pressure medication: Avapro, metoprolol XR, hydrochlorothiazide",,"Hypertension, reactive airway disease, GERD",,morphine,"['Arthralgia', 'Cough', 'Feeling cold', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,IM 933964,IL,44.0,F,"1/7/21 9pm- low grade Fever, chills, sore arm at injection site. 1/8/21 2pm-low grade fever, sore arm at injection site, left axilla pain and swollen left axillary lymph nodes 1/9 to- present: swollen axillary lymph nodes and tenderness left axilla",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Metoprolol succ ER 25mg, lisinopril 10 mg, cetrizine hcl 10mg, vitamin c 500mg, zinc 50mg, vit D, hair skin and nails extra strength, digestive advantage probiotics, yoli alkalete supplement.",None at time of vaccination,"Sinus tachycardia, high blood pressure, overweight",,"Allergic to erythromycin, and environmental allergies","['Axillary pain', 'Chills', 'Injection site pain', 'Lymphadenopathy', 'Pyrexia', 'Tenderness']",2,PFIZER\BIONTECH,IM 933965,IN,81.0,F,"Found on floor by CNA at 6 am. On assessment by charge nurse, VS: 99.6-94-16 212/105 manual. Noted increased confusion. Temp. 99.6 FBS 114. Resident had been provided tylenol just prior in shift for general discomfort (sore muscles) and low grade temp. On call for Dr notified of all and received order to send to ER.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/07/2021,01/08/2021,1.0,SEN,allopurinol tablet; 300 mg; amt: 300mg; oral Once A Day; Upon Rising Prescription 04/06/2019 - Open Ended furosemide tablet; 40 mg; amt: 40mg; oral Once A Day; Upon Rising Prescription 04/06/2019 - Open Ended levothyroxinet tablet; 50 mcg;,,"E11.9 Type 2 diabetes mellitus without complications 09/14/2018 J98.4 Other disorders of lung Note:restrictive lung disease 09/14/2018 D50.9 Iron deficiency anemia, unspecified 09/14/2018 E78.5 Hyperlipidemia, unspecified 09/14/2018 I73.9 Peripheral vascular disease, unspecified 09/14/2018 I48.0 Paroxysmal atrial fibrillation 09/14/2018 I13.0 Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease 04/06/2019 F41.9 Anxiety disorder, unspecified 09/14/2018 F33.1 Major depressive disorder, recurrent, moderate 02/21/2019 M19.90 Unspecified osteoarthritis, unspecified site 04/06/2019 E03.9 Hypothyroidism, unspecified 09/14/2018 F41.0 Panic disorder [episodic paroxysmal anxiety] 09/14/2018 R44.3 Hallucinations, unspecified 09/14/2018 M10.9 Gout, unspecified 09/14/2018 I50.32 Chronic diastolic (congestive) heart failure 11/01/2018 N18.3 Chronic kidney disease, stage 3 (moderate) 04/06/2019 K30 Functional dyspepsia 09/14/2018 R45.1 Restlessness and agitation 09/14/2018 G47.00 Insomnia, unspecified 09/14/2018 M53.87 Other specified dorsopathies, lumbosacral region Note:DJD 09/14/2018 E04.2 Nontoxic multinodular goiter 09/14/2018 R29.6 Repeated falls 11/01/2018 R26.2 Difficulty in walking, not elsewhere classified 09/14/2018 M62.81 Muscle weakness (generalized) 09/14/2018 R53.1 Weakness 11/01/2018 R26.81 Unsteadiness on feet 09/14/2018 E66.01 Morbid (severe) obesity due to excess calories 09/14/2018 Z87.440 Personal history of urinary (tract) infections 04/07/2019 Z87.891 Personal history of nicotine dependence 04/06/2019 Z87.81 Personal history of (healed) traumatic fracture 04/06/2019 Z51.89 Encounter for other specified aftercare 09/14/2018 R50.9 Fever, unspecified 07/20/2020 R26.89 Other abnormalities of gait and mobility 04/24/2020 L97.811 Non-pressure chronic ulcer of other part of right lower leg limited to breakdown of skin 09/27/2019 M15.0 Primary generalized (osteo)arthritis",,"codeine phosphate (bulk), enalapril maleate, oxycodone-aspirin, Penicillins (PCN)","['Blood glucose increased', 'Confusional state', 'Discomfort', 'Myalgia', 'Pyrexia']",UNK,MODERNA,IM 933966,NV,65.0,F,"Injected just under the bone; to high. With in 5 minutes a sharp shooting pain felt in Right shoulder extending down arm followed by a deep throbbing in deltoid and shoulder. This faded. Later in the day soreness like post shingles vax coupled with inability to move my arm, intense shoulder pain . Alternate ibuprofen and Tylenol, moist heat and rest. Today with 800 mgs of ibuprofen I can type but shoulder has limited mobility and is painful",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,niacin tid; multi vitamin,none,none,,augmentin,"['Injected limb mobility decreased', 'Injection site pain', 'Pain', 'Pain in extremity', 'Product administered at inappropriate site']",1,MODERNA,IM 933967,IN,81.0,M,mild headache and mild muscle aches - mostly gone 48 hours after receiving vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/01/2021,,UNK,"Xarelto, Sotolol, Atorovastatin",none,AFib in past but 100% under control with meds,,none,"['Headache', 'Myalgia']",UNK,MODERNA, 933968,OH,45.0,F,"patient reported feeling lightheaded and nauseous, having several dry heaves but not producing vomit",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,WRK,unknown,unknown,,,Penicillin,"['Dizziness', 'Nausea', 'Retching']",1,MODERNA,IM 933970,MI,89.0,M,"26cm x 18cm reddened warm area noted to right upper arm, RT upper arm remains red, swollen, and warm to touch",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/09/2021,2.0,SEN,,,,,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 933974,IL,54.0,F,"""1/10/21 I go the 2nd shot. My blood pressure dropped and they had to lay me down. It went to 90/40, I broke out in a rash on my neck, I am achey all over today 1/11/21""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,,,,,none reported,"['Blood pressure decreased', 'Pain', 'Rash']",2,PFIZER\BIONTECH,SYR 933975,WI,55.0,F,"Left eye blurred vision, ASC. consulted Ophthalmologist on 1/8/2021, Provider stated to ASC. that vision appears to be impacted by viral infection and should resolve without intervention per ASC., also numbness surrounding orbit of left eye",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/25/2020,3.0,PVT,Paxil,,,"Flu vaccination-Fever, chills and body aches 2x","PCN, Ampicillin, Cclor, Macrodantin, Tretrocycline","['Hypoaesthesia eye', 'Viral infection', 'Vision blurred']",1,PFIZER\BIONTECH,IM 933976,CA,71.0,M,- Injection site pain - Chills - Headache - Fatigue - Muscle and joint pain - Mild nausea Same symptoms as Covid 19 infection. - Acetaminophen - Ibuprofen Lasted about 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Atorvastatin Aspirin 21 mg Multivitamin, generic Omega 3",Covid 19,Elevated cholesterol,,None,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain']",1,MODERNA,IM 933977,NY,61.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,OTH,"Briviact, Topamax, protonix, florinef, prednisone, klonipin, vitamin D, Vitamin K, B complex, calcium, colace, lactaid tablets, tirosant, singulair, Qvar","Lupus, OSA, Need for non-invasive ventilation, POTS -hyperadernergic, dyspnea, diaphragm dysfunction and loss of sigh in left eye","Partial complex seizures, diverticultitis with colectomy, Erlos-Danler, Celiac sprue, Hypothyroidism, Back pain, T-12 myelitis",,"Anaphalaxic to Morphine, Opiods, Diprovan, IVP dye, Magnavist, Lidocaine, red dyes, soy, fish, shellfish allergies to compazine, latex, tape,",['Unevaluable event'],UNK,MODERNA,SYR 933978,IN,65.0,M,Pain and tenderness lasting > 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,,,Asthma,,Robaxin Shell Fish,"['Pain', 'Tenderness']",UNK,PFIZER\BIONTECH,IM 933980,MI,61.0,F,"injection site soreness and swelling, sore are with in 1 hour, lasted 48 hours, diarrhea started 13 hours after injection lasted 72 hours. headache started 12 hours after injection lasted 60 hours tiredness started 4 hours after injection lasted 48 hours I only took tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,OTH,"one a day 50+ multivitamin, Acid-A-Cal, vitamin E, Vitamin D2",,"COPD, Laryngopharyngeal, vocal cord dysfunction reflex, sleep apnea low oxygen",,Tamaflu AND Monastat,"['Diarrhoea', 'Fatigue', 'Headache', 'Injection site pain']",2,PFIZER\BIONTECH,SYR 933982,MT,34.0,F,"fever, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/10/2021,2.0,PVT,,,,,,"['Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 933984,VT,57.0,F,"No immediate symptoms but after a week, injection area is red and itchy. It looks like a band of red on my left arm. Seems to be dissipating after a couple of days but still a little itchy and still red.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/09/2021,9.0,PVT,None,None,Had Lyme in the past but no lingering issues.,,Aspirin/Sulfa,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 933985,TX,40.0,F,"Fatigue, aches, fever (max 101.3), sore throat, gagging, vomiting x 2",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Fatigue', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'Retching', 'Vomiting']",1,MODERNA,IM 933987,KY,31.0,F,I got fatigue a few hours after vaccine and resolved after a nap of 3 hours. My arm also still has soreness at the injection sight when touch and area around my underarm hurts with movement.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,"Buspirone 10 mg, Cetirizine 10 mg",No,Anxiety,Fatigue,Certain metals,"['Axillary pain', 'Fatigue', 'Injection site pain']",2,PFIZER\BIONTECH,SYR 933988,IL,56.0,F,"Moderna COVID-19 Vaccine EUA. After receiving the vaccine on 01/08/2021, started to experience pain in left arm which increased in intensity as the day progressed. Took 800mg Motrin with minimal relief. Took an additional 800 mg of Motrin again at bedtime. Woke up on 01/09/2021 with headache, muscle and joint pain, pain in left arm and shoulder, and fatigue. Took Tylenol and Motrin through out the day. Woke up on 01/10/2021 with red swollen eyes and face, and a rash (hives) on neck, stomach, back, and antecubital spaces. Experienced nausea during day. Took Benadryl and Tylenol through out the day. Hives and swelling decreased with second dose of Benadryl. Today, still some fatigue and pain in left arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,MIL,"Synthroid, Vitamin D, Vitamin B6, and Vitamin B12",None,Hypothyroidism,,"Cipro, Augmentin, MRI Contrast Dye (Gandolinium), and gluten","['Arthralgia', 'Erythema', 'Eye swelling', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Ocular hyperaemia', 'Pain in extremity', 'Rash', 'Swelling face', 'Urticaria']",1,MODERNA,IM 933989,,55.0,F,"Patient experienced throat tightness, chest tightness, lightheadedness, and anxiety which did not subside after 30 minutes of observation. She was transferred to the ED for further evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,01/11/2021,0.0,UNK,,,,,,"['Chest discomfort', 'Dizziness', 'Throat tightness']",1,PFIZER\BIONTECH,IM 933990,TX,34.0,F,"Pt received the 1st dose for Moderna-Covid-19 vaccine on 12/23/2020. When information for database was documented, it was found, she had the 1st dose for Pfizer Covid-19 vaccine on 12/17/20. She was notified and spoke with one of our physician, She did not report any sides effects. Pfizer and Moderna pharmaceutical's were reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/06/2021,14.0,PVT,,,,,,"['Inappropriate schedule of product administration', 'Interchange of vaccine products']",1,MODERNA,IM 933991,CA,49.0,F,Fever body aches chills,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/10/2021,1.0,UNK,,,,,,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 933992,NJ,48.0,M,"JAN. 6 THIS WRITER RECEIVED FIRST DOSE OF PFIZER-BIONTECH COVID VACCINE, AT MY HOSPITAL. AFTER VACCINATION ONLY FELT SORENESS ON THE INJECTION SITE, JAN.7 TO JAN 9 FEEL FINE, BY JAN 10TH PAST MIDNIGHT TO 1AM STARTED TO SNEEZE, LOSS OF VOICE, SORE THROAT AND NASAL CONGESTION. TODAY JANUARY MORE SYMPTOMS ADDED LIKE NON PRODUCTIVE COUGH AND HEADACHE.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/10/2021,4.0,PVT,METFROMIN 500MG.,NONE,"DIABETES, HYPOTHYROIDISM, HIGH CHOLESTEROL",,NONE,"['Aphonia', 'Headache', 'Injection site pain', 'Nasal congestion', 'Oropharyngeal pain', 'Productive cough', 'Sneezing']",1,PFIZER\BIONTECH,IM 933993,NJ,52.0,F,Patient experienced slight fever 99.5 and vomiting on Saturday - 1/9/2021. Symptoms resolved by 1/10/2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,PVT,unknown,unknown,unknown,,"cefazolin, sulfa","['Pyrexia', 'Vomiting']",1,MODERNA,IM 933994,IN,64.0,M,"sore arm, chills/shivers",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/10/2021,2.0,PUB,"Benedryl, melatonin",none,none,"Shingrix, shiver and chills",none,"['Chills', 'Pain in extremity']",1,MODERNA,IM 933995,NM,27.0,F,"Fatigue, body aches, diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,Ibuprofen,None,None,,"Cephalosporins, sulfa antibiotics","['Diarrhoea', 'Fatigue', 'Pain']",UNK,PFIZER\BIONTECH,IM 933996,MS,35.0,F,"At 2 am on 1/9/2021 I woke up with a 102 fever, chills, and body aches. After taking some Tylenol and finally getting some sleep I woke up around 11 am 1/9/2021 during the whole day I have body aches and fever Saturday 1/9/2021 night I continued to have fever Sunday 1/10/2021 morning I woke up extremely nauseous that subsided about mid day and then sunday had low grade fever again Monday 1/11/2021 I still have some body ache and fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,,none,none,,NKDA,"['Chills', 'Fatigue', 'Nausea', 'Pain', 'Pyrexia']",UNK,MODERNA,SYR 933997,IL,33.0,F,"On 1/4 developed dime sized redness over vaccine site which on 1/5 enlarged with firmness, erythema and puritus. On 1/6 developed swelling to antecubital area which was gone by 1/7. On 1/7 developed erythema and petechiae to both upper arms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/05/2021,6.0,PVT,,None,,,Cardizem,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Petechiae']",1,MODERNA,IM 933998,IN,27.0,F,"Migraine, body aches, chills, nausea beginning at 0300 the next day after receiving vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,"Metoprolol, florinef, Wellbutrin, Lexapro, birth control pill, melatonin, Vit D, Magnesium",,"Neurocardiogenic syncope, chronic Lyme disease",,,"['Chills', 'Migraine', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 933999,MI,89.0,M,"RT upper arm remains red, swollen, and warm to touch, 26 cm x 18 cm",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/09/2021,2.0,SEN,,,,,,"['Erythema', 'Peripheral swelling', 'Skin warm']",1,MODERNA,IM 934000,GA,33.0,F,Redness and swelling and hardness and pain to injection site a week later with rash and muscle pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/09/2021,8.0,PVT,"Multivitamin, b12, vitamin d, probiotic, biotin",None,None,,"Pcn, cephalosporins","['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site rash', 'Injection site swelling']",1,MODERNA, 934001,MT,35.0,F,"chills, muscle pain, joint pain, fever, Headaache, GI upset, fatigue-resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/10/2021,2.0,PVT,,,,,,"['Abdominal discomfort', 'Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934002,CA,31.0,F,"Daily Headaches (no change in sleep, exercise, or other routine; no change in diet, medications, etc in that time)",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/25/2020,5.0,WRK,"Prenatal Vitamin, Vitamin D3, COQ10, PQQ, Choline, Alpha Lipoic Acid, Melatonin",None,None,,Bactrim,['Headache'],1,PFIZER\BIONTECH,IM 934003,IN,57.0,F,"fatigue, chills, body aches, shortness of breath, tachycardia, nausea, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,SEN,,,Asthma,,,"['Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Tachycardia']",UNK,MODERNA,IM 934004,,46.0,M,"Symptoms began at 8:00 AM the day after vaccination 12/30/2020. Had nausea, but no vomiting. By noon the nausea ended and began to have chills and run a fever. Fever of 101.9. Broke by 4:00 PM. Then had fatigue until end of day 12/30/2020. No other symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,hydrochlorot 25mg losartan 100 mg amlodipine 10 mg,none,hypertension,,No know allergies,"['Chills', 'Fatigue', 'Nausea', 'Pyrexia']",1,MODERNA,SYR 934005,MA,64.0,F,Reported that she received the Moderna vaccine 12/30/2020. As of 1/7/2020 the employee began to itch at the injection site and it became red and warm to touch. The area of redness was 6 inches by 3 inches. Redness was blanchable. Employee marked the areas and reports that it did not extend. Reported that during the day it became less red. Employee sent photo of rash. Employee was advised on how to monitor and manage symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,PVT,"CALCIUM ORAL�once daily CHONDROITIN SULFATE once daily MULTIVITAMIN ORAL� once daily aspirin 81 MG EC tablet�once daily ibuprofen (ADVIL,MOTRIN) 200 MG tablet� by mouth every 6 (six) hours as needed for pain meclizine (ANTIVERT) 25 mg ta",,Knee pain,,NKA,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 934006,KS,55.0,F,I ended up loosing my sense of smell on 1/10/2021 around 9 am in the evening. I am not sure if this is related to the vaccine or just that i might have covid but I got tested this morning at the drive thru testing. I will get my results in 2-3 days. I have not received any other treatment as of this morning I am not having anything but the lost of smell and still congested.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/10/2021,3.0,UNK,"Vitamin C, Zinc, Vit A, Calcium, Magnesium and D3, Propolis, Garlic, One A Day multi vitamin 50+, CoQ10, Amino Complete, Aspirin 81 mg, Aller-Ben, Allergy relief, Esomeprazole Magnesium, Probiotic Pearls Medications - Lisinop/HCTZ 10 mg, Fl",Nothing that i know of. I have on going sinus issues and so sometimes itching so I struggle with that. I did not have a fever or aches before I got my vaccine some congestion.,"High Blood pressure, racing heart, diabetes that is controlled by diet no medications and not even prediabetic any more and allergies",,antiboitics most all of them cause itching when taken,"['Anosmia', 'Respiratory tract congestion', 'SARS-CoV-2 test']",1,MODERNA,IM 934007,OK,76.0,F,"101 degree temperature, headache from day of injection which was a Saturday, Sunday and Monday, severe body aches,. tender nodes in neck, felt very ill, slept 24 hours, no appetite, itching.. I have improved but still itching and have hedache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,"Simvastatin for cholesterol, Metropolol,for HTN , baby aspirin",None,None,,Penicillin,"['Body temperature increased', 'Decreased appetite', 'Headache', 'Lymph node pain', 'Malaise', 'Pruritus']",1,MODERNA,SYR 934008,KS,50.0,F,"Body Aches, Chills, Increased Heart Rate",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Clonazepam, Escitalopram, Fish Oil, Hydorchlorothiazide, Vitamin B-12",Positive Covid 19 12/9/2020,"Hypertension, Anxiety, GERD, Hypercholesterolemia, Hypothyroidism,",,Penicillin,"['Chills', 'Heart rate increased', 'Pain']",1,MODERNA,IM 934009,TX,26.0,F,Extreme soreness on arm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,UNK,Levimir,,Diabetes type 1,,,['Pain in extremity'],UNK,MODERNA, 934010,UT,25.0,F,"24 hours after vaccination-pt developed hives, fever, chills, swelling, redness and warmth at injection site. mild nerve pain in left arm. Treated with benadryl and ibuprofen. Hives, fever/chills have resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,WRK,,,,,"history of antibiotic allergies, no anaphylactic reactions","['Chills', 'Injection site erythema', 'Injection site swelling', 'Injection site urticaria', 'Injection site warmth', 'Neuralgia', 'Pyrexia', 'Urticaria']",1,MODERNA, 934011,MD,45.0,F,RECEIVED VACCINE ON 12/29 AND STARTED RED ITCHY REACTION ON 1/8.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/08/2021,10.0,PVT,,,,,,"['Erythema', 'Pruritus', 'Skin reaction']",1,MODERNA,IM 934012,UT,32.0,F,"I'm not positive if this is a reaction from the vaccine, I know they want all oddities and abnormal findings reported. Approx 7 days (1/7/21) post vaccination, I initially thought I had gotten bitten by something on my left arm where I got the vaccination. Over the course of the next several days I marked out as the area continued to grow. There is no pain associated with it, only a slight itch ocassionally. It does continue to slightly spread, but nothing significant. I do have pics and documentation of needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/07/2021,8.0,UNK,"Lisinopril, nuvaring, Escitalopram",None,"Hypertension, anxiety",,"Latex, blueberries",['Injection site pruritus'],1,MODERNA,IM 934013,PA,27.0,F,"10pm: shaking and feeling extremely cold 12pm: after shaking for hours, became nauseous and experienced dizziness, followed by a syncopal episode, followed by a cold sweat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,Levothyroxine,,Under active thyroid,,,"['Cold sweat', 'Dizziness', 'Feeling cold', 'Nausea', 'Syncope', 'Tremor']",1,MODERNA,IM 934015,TX,63.0,F,"unsteady gait, incontinence, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/02/2021,3.0,OTH,"Calcium, aspirin 81 mg",None,Osteoporosis,,None,"['Fatigue', 'Gait disturbance', 'Incontinence']",1,MODERNA,IM 934016,MT,23.0,M,"Fever, injection site swellin, chills, headache, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/10/2021,3.0,PVT,,,,,,"['Chills', 'Headache', 'Injection site swelling', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934017,MI,76.0,F,red swollen area 10x10cm noted on resident's right upper arm. warm to touch denies pain or discomfort.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/10/2021,1.0,SEN,,,,,,"['Injection site erythema', 'Injection site swelling', 'Skin warm']",1,MODERNA,IM 934018,MN,65.0,F,Swollen neck starting below right ear down jaw line. Tenderness and full feeling,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,PVT,"levothyroxine, coumadin, Triametrine, Zync, D3, multivitamin",none,none,,none,"['Feeling abnormal', 'Swelling', 'Tenderness']",1,PFIZER\BIONTECH,IM 934019,TX,52.0,F,"warm, red rash at inj site. grew larger on day 2 and larger again on day 3. began to fade on day 4.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,01/03/2021,12.0,WRK,dexelant citalopram blisovi fe phentermine allergy pill,,,,nkda,"['Injection site rash', 'Injection site warmth', 'Rash erythematous']",1,MODERNA,SYR 934020,IN,48.0,F,"Red , swelling , soreness and hot to touch just below injection site (1 inch below)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,"Myrbetriq, omeprazole, vit d, vit c, multi vit, probiotics, cranberry, juice plus",,,,"Dilaudid, keflix","['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA, 934021,PR,47.0,F,"Five hours after vaccination developed Left scapula pain, chills, headache, body ache , general malaise end left axillary pain",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,WRK,Percogesic,none,Back Pain,,ASA,"['Arthralgia', 'Axillary pain', 'Chills', 'Headache', 'Malaise', 'Pain']",2,PFIZER\BIONTECH,IM 934023,IN,60.0,F,"Fever 102.2, chills, body aches, nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Cymbalta 90mg 1x/d,,migraines,,,"['Chills', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934025,CA,36.0,F,Day 5 (1/6/21) at 6:45am- notice red swelling around the injection site also itchy and was hard.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,,,PVT,"multivitamin, iron, vitamin c, herbal",,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 934026,AZ,43.0,F,axillary adenopathy on injection side 48 hrs headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,oral contraceptive,None,None,,None,"['Headache', 'Injection site lymphadenopathy', 'Lymphadenopathy']",UNK,PFIZER\BIONTECH, 934027,TX,82.0,M,"Starting the day following vaccination, patient's vaccinated arm became extremely sore all the way down, rated 10/10 on pain scale. Patient has been taking Tylenol, ibuprofen, and Aleve for pain relief, pain is currently less than previous (about a 4/10).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,,,,,,['Pain in extremity'],1,MODERNA,IM 934028,UT,32.0,F,Patient received her covid vaccine on 12/28/2020 in her left arm. Three days after vaccination she had pain and swelling in her right arm. She was seen by a health care provider on 12/31/2020 and an ultrasound showed extensive deep venous thrombosis in the left arm. She was started on a blood thinner (eliquis). She had blood tests done on 1/1/20 and this showed leukocytosis. She was found to have acute myeloid leukemia and admitted to our service for treatment. We do not have blood tests prior to 1/1/20 so it is unclear when her leukemia started. Her deep venous thrombosis could be related to her acute leukemia but I decided to report it due to the proximity to the time of her vaccine. Her arm pain and swelling improved after administration of the blood thinner. She is currently being treated for her leukemia.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/31/2020,3.0,UNK,none,none,none,,none,"['Acute myeloid leukaemia', 'Deep vein thrombosis', 'Laboratory test abnormal', 'Leukocytosis', 'Pain in extremity', 'Peripheral swelling', 'Ultrasound scan abnormal']",1,PFIZER\BIONTECH,IM 934029,,36.0,F,Post vaccine Day 5 post temp at 101.5 and Day 6 T 100,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/10/2021,5.0,WRK,,,,,,['Body temperature increased'],1,PFIZER\BIONTECH,IM 934030,KY,33.0,F,"Severe itching, rash around site, warm to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,PUB,"Lexapro 20 mg, Claritin 10 mg, Prenatal Vitamin",None.,Anxiety.,,"Allergy to some topical lotions, seasonal allergies, itching around site when receives tubersol for TST's.","['Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,MODERNA,IM 934031,CA,41.0,F,"malaise, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/10/2021,0.0,PVT,,,,,,"['Chills', 'Malaise']",2,PFIZER\BIONTECH,IM 934032,IN,33.0,M,Severe Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,"Synthroid, Citalopram, Clonazepam, Birth Control, Iron, Vitamin C, Vitamin D, Fish Oil",None,"Hypothyroidism, Anxiety",,Pineapple,['Headache'],2,PFIZER\BIONTECH,IM 934033,AL,53.0,F,"soreness in arm, not just to the touch, but hard to lift arm the next day. Better after day 2.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Levothyroxine; Pravastatin; Estradiol-Noreth; Vitamin D; Multi-vitamin,None,Hashimoto's,,Penicillin,"['Mobility decreased', 'Pain in extremity', 'Tenderness']",UNK,PFIZER\BIONTECH,IM 934034,KY,52.0,F,"SAME DAY OF VACCINE AND 2 DAYS AFTER START OF WELLBUTRIN, PT DEVELOPED PAINFUL RASH ON BOTH ARMS ONLY AND ON HAND. THERE IS NO ITCHING; AT FIRST, SHE WORKED AND FELT OKAY, BUT THE RASH HAS PROGRESSIVELY GOTTEN WORSE AND IS NOW ON NECK AND FACE AND SHE HAS NOT BEEN ABLE TO WORK.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,melatonin Tylenol prn wellbutrin (started 12/27/20),"small rash, like 3-4 bumps on left hand prior to vaccine",ulcerative colitis and rheumatoid arthritis,,penicillin: anaphylaxis codeine: hives and whelps all over body,"['Impaired work ability', 'Rash']",1,MODERNA,IM 934035,MA,28.0,M,"Moderna COVID-19 Vaccine: I experienced chills, whole body fatigue, injection site pain, headache, and elevated temperature (98.8 and 100.0). Symptoms completely resolved on Thursday 1/7/21. I also experienced symptoms of vertigo (dizziness and nausea) beginning Friday 1/8/21 that lasted till 1/10/21 and am not sure if related or not. I do have a history of vertigo and am prescribed meclizine. Meclizine was taken with minor relief.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Daily Allegra (antihistamine) in the morning.,NONE,Asthma,,Penicillin,"['Body temperature increased', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Vertigo']",1,MODERNA,SYR 934036,IN,50.0,F,"Patient reported arm red, warm to touch and arm aches after vaccine administration. Moderna vaccine given. No treatment given",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Erythema', 'Pain in extremity', 'Skin warm']",1,MODERNA, 934037,NY,57.0,F,Patient calls she received the covid vaccine 01/07/2021 on 01/10/2021 she started experiencing numbness from lip to lower chin she is wondering if this would be a side effect of the vaccine reports she has had bells palsy in the past but it feels a little different . She has also had a headache since receiving the vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,,04/15/1963,01/10/2021,21090.0,PVT,Klonipin 1mg,None reported,Bells Palsy?,,Sulfa,"['Headache', 'Hypoaesthesia', 'Hypoaesthesia oral']",1,MODERNA,IM 934038,MO,39.0,F,"Redness and itchiness to chest and lower neck around nose as well as minor tongue swelling. I was vaccinated at 0710, waited my 15 minutes drove home ( 15 min) showered and then just before 9 am realized Inwas itchy. Checked chest area and had red blotches similar in pattern to an anaphylactic reaction I had a few years earlier to betadine exposure. The night of the vaccine Inwoke up with nasal congestion and rhinorhea, itchy ears and throat, watery eyes. This became worse throughout the following day where I continued benadryl 50mg q6 as well as alternating tylenol and ibuprofen for body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,OTH,"Prozac, symbicort, zyrtec, vit d",Asthma Anxiety Scapular dyskinesia Carpal tunnel Cubital tunnel Lumbar stenosis,Asthma Anxiety Scapular dyskinesia Carpal tunnel Cubital tunnel Lumbar stenosis,,Iodine anaphylaxis Betadine anaphylaxis Shellfish anaphylaxis,"['Erythema', 'Lacrimation increased', 'Nasal congestion', 'Pain', 'Pruritus', 'Rash macular', 'Rhinorrhoea', 'Swollen tongue', 'Throat irritation']",1,PFIZER\BIONTECH,IM 934039,DC,71.0,F,"After 7 days my arm began to swell and hurt. Raised rash started to form and arm became warm to touch. Each day after the initial discovery, the rash grew larger and the pain and heat grew in intensity. I iced my arm and took 3 Advil. As of today the swelling has subsided. The redness now is across the entire front of my arm but the pain no longer prevails.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/05/2021,7.0,UNK,Synthroid 88mg Carbadopa-Levadopa 25/100 Vitamin D Vitamin B1 Tylanol Arthritis,,Parkinson Disease,,,"['Erythema', 'Pain in extremity', 'Peripheral swelling', 'Rash', 'Rash papular', 'Skin warm']",UNK,MODERNA, 934040,CA,30.0,F,"body aches, chills, dizziness, headache. Improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/10/2021,0.0,PVT,,,,,,"['Chills', 'Dizziness', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 934041,MT,23.0,M,"Fever, injection site swelling, chills, headache, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/10/2021,3.0,UNK,,,,,,"['Chills', 'Headache', 'Injection site swelling', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934042,OK,47.0,U,Patient reported fever after getting Covid 19 BioNTech Pfzifer vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,UNK,,,,,,['Pyrexia'],UNK,PFIZER\BIONTECH, 934044,,49.0,F,"Lymph pain, low grade fever, aches",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Lymph node pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934045,MN,82.0,F,"Noted a 6x13cm red area to injection site. Area warm to touch, edematous, non-tender, not itchy. Resident had no complaints and stated she didn't even know it was there, VS stable, ROM to extremity WNL, will continue to monitor in house and alert PCP as needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/11/2021,4.0,SEN,"methotrexate, simvastatin, losartan, HCTZ, Folic Acid, Vitamin D3, protonix, ensure",COVID/Pneumonia 11/21/2020,"Rheumatoid arthritis, hypertensive heart disease, hyperlipidemia",,Penicillin,"['Injection site erythema', 'Injection site oedema', 'Injection site warmth']",1,MODERNA,IM 934046,NJ,32.0,F,"Soreness in site of injection, left deltoid area; Next day developed headache, chills, fatigue, body ache and back pain that lasted 24 hours. Symptoms resolved in 24 hours, felt a lot better in 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,Prenatal vitamins and glucosamine,NONE,NONE,,NONE,"['Back pain', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pain']",1,MODERNA,IM 934047,SC,61.0,F,"Upper and lower lip and inside of lower lip broke out in blisters - treated with acyclovir, viscous lidocaine and Maalox",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,SEN,"Ventolin, advair",None,Asthma,,No,['Lip blister'],1,MODERNA,IM 934048,,49.0,F,"chills exhaustion, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Fatigue', 'Feeling cold', 'Headache']",2,PFIZER\BIONTECH,IM 934049,IN,81.0,F,"Friday afternoon ... headache and right thigh muscle discomfort . Saturday ... headache and more thigh muscle discomfort. By night, muscle ache was continual and continued throughout the night. Very difficult to walk. Sunday ... called Telehealth around noon, They triaged me into Dr.'s office. By Sunday afternoon, less discomfort, but still a headache. During this discomfort time, I would take 2 Tylenol (500 mg), which relieved it. Before I settled down for the night, I took 1 Tylenol and when I woke up at 3:00 a.m., the ache was not there (the Tylenol would have worn off by then). Monday a.m. ... could walk much better. The headache and the constant muscle ache are gone. Nurse called; I am to keep watch, and if there are any changes for the worse, I will go into the Dr.'s office.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,UNK,Warfarin - Pravastatin Multi-vitamin - calcium w/D3 - vitamin D3 - low dose aspirin - Ultimate Omega,None,Mechanical Heart Valve,,None,"['Gait disturbance', 'Headache', 'Muscle discomfort', 'Myalgia']",1,PFIZER\BIONTECH,SYR 934050,KS,68.0,M,"Staff reported that patient was found Friday morning (Jan 8) sitting at a table with his head tilted forward and unresponsive to verbal or physical stimuli. Staff lowered patient to floor and started CPR. EMS was called and continued CPR at scene, however they were not able to revive patient. Patient was pronounced dead at the scene. Staff written statements following the death of patient show that he had a fall about 1 hr. prior. It is unknown if this fall contributed to patient's death. An autopsy has been requested.",Yes,01/08/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,SEN,Patient was a resident in Group Home Current Medications Treatments/PRN Medications: Start Date: 04/02/14: Benztropine 2mg tab BID (8-8) 02/27/15: Midodrine (Proamatine) 5mg tab TID (8-12-8) 12/30/15: Cetirizine 10mg tab daily @8am 1,No Acute Illnesses,Diagnosis: - Impulse Control Disorder - Epilepsy - Tardive Dyskinesia - Ulcerative Proctitis and Colitis - Mental Retardation (mod) - Hammer toes (bilat.) - Dermatitis (scalp/torso) - Seborrheic keratosis of left armpit - Major Depression - Infantile Meningitis - History of Squamous Cell Carcinoma (L arm),,Allergies: NKDA,"['Death', 'Fall', 'Posture abnormal', 'Resuscitation', 'Unresponsive to stimuli']",1,MODERNA,IM 934051,MA,24.0,F,Patient reports 1/7/2021 that she noticed that the injection site has localized redness and is slightly swollen but does not hurt. The arm was red but reported to be painless.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,PVT,None,None,,,NKA,"['Erythema', 'Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 934052,GA,46.0,F,"Severe rigors, chills, arthralgia Fever 104 extreme pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,zoloft claritin,none,allergies,,none,"['Arthralgia', 'Chest X-ray', 'Chills', 'Culture urine', 'Full blood count', 'Metabolic function test', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 934053,VA,28.0,M,"Within an hr after vaccination I had pain at injection site, fever, chills, headache for 2 days and tested positive for covid-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,,,Narcotic pain medication,"['COVID-19', 'Chills', 'Headache', 'Injection site pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 934054,CA,,F,"1/5 slight fatigue 5:30 am and sore arm 1/6 I took ibuprofen but still had pain 1/8 I felt pain in arm pit but it got a little 1/9 pain progressed to arm pit 1/10 pain still under arm and tender 1/11 My arm is sore with bump on injection site, warm to touch and painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,atrovastatin,no,Hyperlipidemia,,no,"['Axillary pain', 'Fatigue', 'Injection site pain', 'Injection site rash', 'Injection site warmth']",1,MODERNA,SYR 934055,,29.0,F,"Vitals : heart rate 140?s after reaction noted. After taken to ED for assessment- Temp 36.7, RR 16, Pulse 92-96, BP 115/68 and 104/66. SpO2 99-100% on room air Reaction: pale, lightheaded, said she felt like she ?was in a tunnel? after receiving vaccine, but felt better by the time she got to ED. Impression from provider: ?Acute Vasovagal response to injection?",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Dizziness', 'Feeling abnormal', 'Heart rate increased', 'Pallor', 'Presyncope']",UNK,PFIZER\BIONTECH,IM 934056,NM,54.0,F,"Extreme fatigue 48 hours after shot. Nausea/vomiting and headache. Flu like symptoms lasted about 24 hours and then subsided. Self treated with Tylenol, hydration and rest and felt better. The symptoms seemed to develop suddenly after I went for a 8 mile run on Saturday afternoon 1/9/21 about 48 hours after getting the shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,SEN,None,None,None,,None,"['Fatigue', 'Headache', 'Influenza like illness', 'Nausea', 'Vomiting']",1,MODERNA,SYR 934057,VA,40.0,M,"AT APPROXIMATELY 1000, PATIENT BEGAN COMPLAINING OF FEELING ""VERY NAUSEOUS"" AND NEEDED A BIN. PATIENT WAS BROUGHT BACK INTO THE IMMUNIZATIONS CLINIC FROM THE WAITING ROOM. ONCE SEATED, PATIENT THEN BEGAN FEELING ""HOARSE AND TROUBLE BREATHING"", WHICH THEN EPI-PEN WAS GIVEN AT 1004. VITALS AFTER EPI PEN BP 133/77 O2 99% HEARTRATE 103. CODE WAS CALLED SIMULTANEOUSLY. PATIENT WAS THEN BROUGHT TO EMERGENCY DEPARTMENT VIA WHEELCHAIR WITHIN THE HOSPITAL BY CODE TEAM.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/11/2021,0.0,MIL,,,,,,"['Dysphonia', 'Dyspnoea', 'Nausea']",2,PFIZER\BIONTECH,IM 934058,IN,55.0,F,"Date of onset: 01/08/2021 - headache, chills and fatigue. Intense headache and chills lasted most of the day on the 8th. The fatigue was most of the weekend. I slept 12 hours on Saturday night the 9th, and preceded to nap in the afternoon on the 10th. Both of these sleep times are very much out of the ordinary for me. I also took 3 doses of Ibuprophen for the headache on the 8th.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,None,None,None,,Nickel and adhesive,"['Chills', 'Fatigue', 'Headache', 'Somnolence']",2,PFIZER\BIONTECH,IM 934059,IA,99.0,F,Acute anterior MI with death,Yes,01/10/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,SEN,"tramadol, calcium, Tylenol, lisinopril, Mucinex, MVI, namenda","Had Covid 19 infection in November recovered, had spinal stenosis with leg weakness chronic",,,anastrozole,"['Acute myocardial infarction', 'Death']",1,PFIZER\BIONTECH, 934060,IA,83.0,M,"APPROXIMATELY 30 MINUTES AFTER VACCINATION, DEVELOPED DIZZINESS AND PRESSURE IN CHEST THAT LASTED UNTIL THE FOLLOWING MORNING.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,SEN,,,,,,"['Chest discomfort', 'Dizziness']",1,PFIZER\BIONTECH,IM 934061,NY,66.0,F,Sore arm for 48 hours that progressively felt better. Some nausea the same day that went away after I ate something. Nothing else to report thus far.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,None,None,None,,None,"['Nausea', 'Pain in extremity']",1,MODERNA,SYR 934063,IL,38.0,F,"7 days after my first Pfizer COVID vaccine, I developed mastitis. It began in the morning with mild generalized muscle and joint pain and progressed to moderate to severe joint pain, a fever of 102 degrees, and localized redness and swelling of the left breast over the course of 12 hours. Treatment with Cephalexin 500 mg PO QID for 14 days was initiated within 12 hours of onset. The systemic symptoms resolved within 24 hours of treatment onset and the breast redness and swelling resolved within 72 hours. While I am aware that an infectious mastitis is likely unrelated to the vaccine, I opted to report this incident because I have breastfed 3 children and have never had mastitis prior to this event and because of the limited information available on this vaccine in lactating women.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/26/2020,8.0,PVT,None,None,None,,Penicillin,"['Arthralgia', 'Breast swelling', 'Erythema', 'Mastitis', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 934064,CO,39.0,F,Injection site red irritated,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/07/2021,8.0,UNK,,,,,,"['Injection site erythema', 'Injection site irritation']",1,MODERNA,IM 934065,PA,74.0,M,"shingles, severe, ongoing, taking antviral medication",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/25/2020,01/05/2021,11.0,UNK,,"HTN, dyslipidemia, migraine headache, CAD, impaired glucose tolerance","HTN, dyslipidemia, migraine headache, CAD, impaired glucose tolerance",,,['Herpes zoster'],1,MODERNA,IM 934066,UT,36.0,F,"Patient began to experience neck pain, myalgias, headache on 12/30. Fever on 1/1.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,UNK,"allegra 60mg daily prn, ibuprofen 800mg q6h as needed",unknown,Mixed hyperlipidemia,,no known allergies,"['Anti-thyroid antibody decreased', 'Anti-thyroid antibody negative', 'Blood thyroid stimulating hormone decreased', 'C-reactive protein increased', 'Full blood count normal', 'Headache', 'Metabolic function test normal', 'Myalgia', 'Neck pain', 'Pyrexia', 'Red blood cell sedimentation rate increased', 'Thyroxine free', 'Tri-iodothyronine free', 'Ultrasound thyroid']",1,PFIZER\BIONTECH,IM 934067,,33.0,M,"2 week post injection. Injection site erythema, itching,warmth. Non spreading. Within 1inch radius of injection site. Not present immediately following injection. No other symptoms at this time. Will continue to self monitor.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/11/2021,13.0,MIL,N/a,N/a,N/a,,N/a,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA, 934068,CA,44.0,F,"Sore arm quarter sized red bump on arm that was warm to touch, itchy and red. it has now turned into about 3x4 in a oval shape",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/08/2021,6.0,UNK,,,,,,"['Erythema', 'Peripheral swelling', 'Pruritus', 'Skin warm']",1,MODERNA,SYR 934069,TN,32.0,F,My arm has a large swollen lump under the skin. It is red and hot to the touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/11/2021,9.0,PUB,,,,,,"['Erythema', 'Limb mass', 'Peripheral swelling', 'Skin warm']",1,MODERNA,SYR 934070,MI,45.0,F,vasovagal episode drop in pulse ox drop in heart rate,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,Tizanidine - 4mg - 1/day Symbicort - 2 puffs/day Albuterol 90mcg - 2 puffs/as needed Buspirone 15 mg - 2/day Montelukast 10mg/day Lamictal 150mg/day Trazodone 100mg - 2 pills/night Visteril 25mg - 2-3/day Metoprolol 25mg/day Omeprazole 20mg,Obese,Asthma Vasovagal syncope History of Blood clots and DVT GERD (gastroesophageal reflux disease) Bipolar disorder/Anxiety/Depression Hyperlipidemia,,Penicillin Wellbutrin,"['Heart rate decreased', 'Presyncope']",2,PFIZER\BIONTECH,SYR 934071,OR,27.0,F,Tachycardia and palpitations within 5 minutes of administration. Lasted for about 5 minutes then resolved. Approximately 20 mins after administration of vaccine minor swelling of the throat and limited rash on the throat present. 50 mg oral Benadryl taken an hour after vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/11/2021,0.0,WRK,Escitalopram Levothyroxine Isibloom,,,,Clindamycin,"['Palpitations', 'Pharyngeal swelling', 'Rash', 'Tachycardia']",1,PFIZER\BIONTECH,IM 934074,MA,56.0,F,eye muscle twitching for 1 day right side head scalp & around right ear pain ( occipital neuralgia) for 4days on going continuously till today 01/11/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,vitamin D,no,no,,no,"['Ear pain', 'Muscle twitching', 'Occipital neuralgia']",1,MODERNA,SC 934075,TX,30.0,F,"7 days after (01/09/21) getting injection, the injection site became itchy, swollen, and warm to the touch. Before it had a small dime sized red spot at injection site with no reaction or issue. then on the 7th (01/09) day the side was about the size of a 50 cent piece, then on the 8th (01/10) day it had doubled in size and was extremely warm, itchy, and swollen. I did an appointment via virtual health and the doctor diagnosed it as Cellulitis. I was put on a week worth of cephalexin 500mg 4x a day. after 3 doses the swelling and itching went down drastically.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/09/2021,7.0,PVT,multi vitamin,none,none,,none,"['Cellulitis', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 934076,NM,33.0,M,"Nausea, Diarrhea, Headache, High fever (104), Body aches, Cold chills. Took 1000mg of Tylenol when fever started, 4mg of Zofran when nausea started, both medications helped. All symptoms stopped the following day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,MIL,Zyrtec 10mg PO Daily Singular PO Daily Valacyclovir 1000mg PO Daily OTC: Biotin PO Daily,Hx of Covid 19: Oct 2020,None,,NKDA,"['Chills', 'Diarrhoea', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 934077,FL,65.0,F,I sat for 30 mins after the vaccine at the doctors office. When I got home I started feeling my heart beating and started feeling like my body was raising. After 10 mins I checked my BP 140/90 which is high for me. I took a BP pill. It took a couple of hours for it to come down to normal. Went to sleep and woke up BP normal and a slight headache. My arm was sore lasting about 3 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,no,immune system problem - spleraderma.,,"Penicillin, erythromycin.","['Blood pressure abnormal', 'Feeling abnormal', 'Headache', 'Pain in extremity']",1,MODERNA,SYR 934078,GA,26.0,M,"Overall feeling unwell, self-treated with ibuprofen for muscle aches and Benadryl for sleep aid due to insomnia from feeling sick",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/09/2021,4.0,PUB,"Fluoxetine, vyvanse, levocetirizine, albuterol, symbicort",,"Asthma, adhd, anxiety/depression",,,"['Insomnia', 'Malaise', 'Myalgia']",1,MODERNA,IM 934079,CA,59.0,F,25 min after injection and said she had itching all over her body started at the injection site then spread throughout her body. She was sent to an NP for evaluation. They advised her to take a BENADRYL and see if that resolved. She came back at 1700 to let us know she was somewhat better but would go home and take an additional BENADRYL. Recommended she contact her primary if symptoms persist or go to UC.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Losartan,no,ITP,,"PNC, macrodantin, ceftin, Levaquin, valium, busbar","['Injection site pruritus', 'Pruritus']",1,PFIZER\BIONTECH,IM 934082,MN,41.0,F,Facial twitching that began about 1-2 hours after injection. The facial twitching lasted about 24 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Multivitamin Vitamin D,none,none,,none,['Muscle twitching'],1,PFIZER\BIONTECH,IM 934083,AR,55.0,F,"After giving the vaccine, we realized she had received plasma antibodies 60 days prior.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PHM,,,,,,['Transfusion'],1,MODERNA,IM 934084,,26.0,F,injection site red irritated,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/07/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site irritation']",1,MODERNA,IM 934085,PR,54.0,F,"Apart from normal reactions like pain in injection site, headache, myalgias, on about fourth day, patient starts seeing a cloud-like blurry vision, intermittently, during the day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/07/2021,3.0,PVT,,,,,Oxycodone,"['Headache', 'Injection site pain', 'Myalgia', 'Vision blurred']",2,PFIZER\BIONTECH,IM 934086,TX,69.0,F,"Headache, off kilter, could not seem to wake up. Lasted all day about 24 hours after vaccine. Took Motrin and slept almost 24 hours. Body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/10/2021,2.0,PVT,Simvastin; Amalodapine; low dose aspirin; Flonase; Levothyroxine; olmestartin; melatonin; probiatic,COPD; Graves disease,high blood pressure; high cholesterol; thyroid,,Penicillin,"['Feeling abnormal', 'Headache', 'Pain']",1,MODERNA,IM 934089,WI,38.0,F,"Right Arm Injection Site extremely sore to touch. Woke up in the morning puking. Broken blood vessels in the face, looked like a rash but dissapated over the course of 3 days. Chills, extreme muscle and joint pain. Very nauseous throughout the day and most of the night. Most of the symptoms went away after the first day, but the muscle and joint pain stayed through Sunday and into Monday morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Arthralgia', 'Chills', 'Contusion', 'Injection site pain', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,SYR 934091,IN,17.0,M,Patient was vaccinated but was out of out of recommended age range. Pharmacist did not recognize error until after injection was complete. Patient did not have any post-injection reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,SEN,,none,none reported,,NKDA,['Product administered to patient of inappropriate age'],1,MODERNA,IM 934092,MO,31.0,F,"""Fever of 99.8 with chills""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,UNK,,,,,,"['Chills', 'Pyrexia']",1,MODERNA,IM 934093,NJ,49.0,M,"Chills, temp 99.9, body aches, soreness at the site.. After 3 days it went away. Left arm is still weaker than right arm. Generally tired. Flu like symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Metoperol,no,high bp,,Sulfur,"['Body temperature increased', 'Chills', 'Fatigue', 'Influenza like illness', 'Injection site pain', 'Muscular weakness', 'Pain']",1,MODERNA,SYR 934094,OK,37.0,F,"Approximately 15 minutes after receiving the vaccine, client started c/o itching to face and lips. Transported to triage area. Where she started c/o burning lips also. vital signs monitored, Benadryl 50mg po given. In a few minutes she reported chest tightness, labored breathing. 1:44pm Epinephrine was given IM. client was on 02 increased to 15 Liters. She admits to decreased chest tightness and itching of face improving. She was taken by ambulance to hospital, where she was admitted overnight for observation. She was given Benadryl and epi X2 more time, once in ambulance and once at the hospital. She denies any problems since then. She did say that approx 3 weeks ago she was a contact to a case of covi",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,"humalog,lantus,omepriazole,topamax,prozac,","migraines, asthma","Diabetes, asthma, migraines",,none,"['Ageusia', 'Chest discomfort', 'Cough', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Lip pruritus', 'Malaise', 'Oral discomfort', 'Pruritus', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 934095,NJ,51.0,F,"Received first dose of vaccine on 12/29/20. Had no reactions and checked in through Vsafe system. On 12/31/20, I lost control of my bladder at work. I did not have the urgency to go, and when I started walking, my bladder emptied. I reported this symptom through Vsafe on that day. This symptom did not happen again. On 1/10/21, I was changing my clothes and my left arm felt itchy. When I itched my arm, I felt little, raised welts. I looked at my arm, and a significant red, irregular shaped spot was on my arm. I could not report this to Vsafe as my check ins had stopped as of 1/6/21. I called my PCP, who directed me to this site to report it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/10/2021,12.0,OTH,"Doxycycline 75 mg (1 tab a day) Serenol (2 tabs a day) Viracid (2 caps a day) Probiotic (1 cap a day) Vitamin D Spray under the tongue Vitamin B (1 tab daily) Flonase (two squirts each nostril, daily)",None,Rosacea,,Erythromycin Walnuts,"['Pruritus', 'Urinary incontinence', 'Urticaria']",1,MODERNA,SYR 934096,CA,69.0,F,"Severe swelling of hand joints- especially the right hand. could not bend fingers. Heavy swelling of neck nodules, ears pain - heavy sweating-chills- heavy body ache- fever- heavy migraine type headache Pain of left arm -vaccine site- could not move/left arm for the last three days. Today is the fourth day, Monday, Jan. 11, and still having same symptoms unable to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,OTH,Tumeric gel,,,,"Naprocin/Naproxen Aspiring (adverse reaction, not allery)","['Chills', 'Ear pain', 'Hyperhidrosis', 'Impaired work ability', 'Injected limb mobility decreased', 'Injection site pain', 'Joint swelling', 'Migraine', 'Mobility decreased', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 934097,NY,63.0,M,fever of 101.5 body aches headache fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PUB,omeprazole fluoxetine hcl valsartan-hctz 320 quetiapine rosuvastatin trazadone bupropion,,,,,"['Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,MODERNA,SYR 934098,,33.0,F,"Fever, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Chills', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934099,IL,41.0,F,"Patient is a 41 y.o. female who presented to the ED with complaints of a reaction after she took the COVID vaccine. Patient is an RN here and had earlier received COVID-19 vaccination (Moderna) around 0130 this afternoon. Soon after she experienced rash which was burning and itchy on her arms thighs and back. She reported to Occ health and was directed to the ED. While in the ED she experienced throat tightness and nausea. She had one episode of diarrhea. No tongue, lip swelling, SOB or difficulty swallowing. Denies any chest pain, palpitations, pre-syncope/syncope. No vomiting abdominal pain. H/o of allergy to fish mix and dust mite.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"topomax, melatonin, mirena ring, B12 injection, zyrtec, biotin",none,"anxiety, depression, hyperprolactinemia, migraines, primary hypothyroidism",,"? shellfish (positive skin test but eats shellfish with ""no problem"")","['Burning sensation', 'Diarrhoea', 'Laboratory test', 'Nausea', 'Rash', 'Rash pruritic', 'Throat tightness']",1,MODERNA,IM 934100,TN,39.0,F,"fatigue, chills, sweating, nausea, 99.1 fever then progressed to a 103 fever, severe pain in legs, took Tylenol and brought fever down to 101.7. Next day, woke up to sunburn rash on face, trunk to groin and legs, fatigue lasting all day. Next day 1/9, rash was still there, fever reached 100 lasting all day and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"Omeprazole, Vitamin C, Multivitamin, Claritin",,,,,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Rash', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 934102,OH,60.0,F,Pain at injection site - 72 hours Chills - 2 hours Fever - (assumed-I did not check it) about 8 hours Headache - 18 hours Body aches - 24 hours Low energy - 36 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,"Metformin, 1500/day Basaglar, 30 units/day Ozempic, 1 unit/week",None,Diabetes,,Sulfa drugs,"['Asthenia', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",1,MODERNA,IM 934103,IN,59.0,F,In afternoon had chills headache fatigue injection sit deltoid sore down to elbow,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PVT,"Calcium , vitamin d , zinc ,daily vitamin",NAnA,,,NkA,"['Chills', 'Fatigue', 'Headache', 'Injection site pain']",2,PFIZER\BIONTECH,SYR 934104,CA,72.0,F,Sore arm chills nausea diarrhea dizzy sweats tired headache,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Chills', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pain in extremity']",1,MODERNA,SYR 934105,NJ,49.0,F,"itchy inner ears, face and arms- started within the hour and lasted 6-24 hours hot flashes- no temp 1/4-1/6 off and on fatigued, headache Diarrhea 1/7-1/8",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Synthroid, duexes",none,hypothyroid,,pcn,"['Diarrhoea', 'Fatigue', 'Headache', 'Hot flush', 'Pruritus']",1,MODERNA,IM 934106,OH,36.0,F,"Diarrhea, nausea, queasy stomach, sour stomach, headache, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/11/2021,4.0,PVT,None,None,None,,Sulfa,"['Abdominal discomfort', 'Diarrhoea', 'Fatigue', 'Headache', 'Nausea']",1,MODERNA,IM 934107,,37.0,F,"Brain fog, fever, aches lymph pain",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/10/2021,1.0,PVT,,,,,,"['Feeling abnormal', 'Lymph node pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934108,OK,84.0,F,"At 4:27 pm client stated she was developing a rash on face. BP 220/110, P 80, R16. Epinephrine .5ml given IM at 4:31pm. Reported tongue felt thick and difficulty breathing, BP 210/100, P 64, R 18. Benadryl 50mg given at 4:34pm, rash on face less, BP 178/88, P 60, R 18. Transferred by private vehicle to Hospital at 4:45pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,unknown,,diabetic,,"codiene, terremycin, iodine, phenegren, neiosporin, latex, morphine, demerol","['Dyspnoea', 'Rash', 'Tongue disorder']",1,MODERNA,SYR 934109,MD,54.0,F,"A knot formed where the injection was given, which swelled and became red. Monitored the area from 12/30/20 to 1/05/21 and it appeared to be slowly going away. However, in the early morning hours of 1/06/21, I woke up to the injection area intensely itching along with increased swelling , and redness. Thurs 1/07/21 I found myself developing hives and itching all over. I now have areas of hives all over my body except for my face.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,"Bystolic 5mg, multivitamin, Red Krill Joint Care, blueberry supplement, and cherry supplement",None at the time of vaccination. Mild congestion 12/05/20 & 12/06/20,"High BP, overweight, and knee joint issues",,"Sulfa Drugs, Dilaudid, and nickel metal","['Injection site erythema', 'Injection site nodule', 'Injection site pruritus', 'Injection site swelling', 'Pruritus', 'Urticaria']",1,MODERNA,IM 934110,TN,43.0,F,"Eight days after the injection (1/7/21), I developed an inflamed rash on my left arm. It was hot to the touch and itched . It was round and approximately 2 inches in diameter. I called my doctor on 1/8/21, and she had me come in and be seen. She diagnosed as cellulitis from a secondary infection at the injection site and prescribed sulfamethoxazole/Trimethoprim 800/160mg every 13 hours for 7 days. The rash started to go away, but on 1/10/21, it began to itch again and became inflamed. On the morning of 1/11/21, it had grown and changed shape. It is now oval and over 3 inches in diameter. It also has a pronounced border. On, that day, I also found out that 2 co-workers had a similar reaction. I spoke with my doctor, who told me to report it to the CDC.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,OTH,"Vitamin D3, zinc, Zyrtec",,"Diabetes, Type II",,NKA,"['Inflammation', 'Injection site cellulitis', 'Pruritus', 'Rash', 'Skin warm']",1,MODERNA,SYR 934111,CO,77.0,F,Body rash,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/10/2021,2.0,PVT,"Losartin, Digoxin, Omeprazole, Flecainide, Anastrozole,meloxicam",,"Hypertension, osteoarthritis",,"Keflex, Cranberries, zinc, sulfa drugs",['Rash'],1,MODERNA,IM 934112,NE,53.0,F,lymphadenopathy under right arm. still on going today,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,aspirin 81 / bystoloic / levothyroxine 50 mg / lisinopril 20-12.5 / nexium 20 mg / zoloft 50 mg /,no,no,,"percocet , morphine , sulfa, penicellin",['Lymphadenopathy'],2,PFIZER\BIONTECH,SYR 934113,,49.0,F,"chills, aches, lymph pain",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,,,,,,"['Chills', 'Lymph node pain', 'Pain']",2,PFIZER\BIONTECH,IM 934115,NE,86.0,F,"DAY AFTER VACCINATION (1/6/21) AT APPROXIMATELY 12:30PM, DEVELOPED FATIGUE, DIFFICULTY TALKING, NAUSEA, AND MALAISE. SYMPTOMS RESOLVED IN 1 HOUR.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,SEN,,,,,,"['Fatigue', 'Malaise', 'Nausea', 'Speech disorder']",1,PFIZER\BIONTECH,IM 934116,MO,31.0,F,"""Fever of 99.8 with chills""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Chills', 'Pyrexia']",1,MODERNA,IM 934117,MO,37.0,F,"Arm soreness throughout entire arm hours 2-24 post vaccine, peak about 12hr then relenting. Myalgias sporadic and brief, with fatigue, 36 hours post vaccine, resolution within 12 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/16/2020,0.0,WRK,,,,Mild arm soreness with TDAP,,"['Fatigue', 'Myalgia', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 934118,SC,45.0,F,"Tested Positive for Covid on January 7, 2021. Symptoms started that morning with a severe sore throat with no redness or exudate. No fever. Head and chest cold symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,01/07/2021,17.0,PVT,Prozac 40 Zyrtec 10 Mirapex 0.50,none,Seasonal Allergies/ Sinus,,All seafood Latex Betadine,"['COVID-19', 'Nasopharyngitis', 'Oropharyngeal pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 934119,NM,55.0,F,"1/5/21 at 1512, employee was having cold like symptoms prior to getting vaccine. REcieved vaccine and next day was feeling SOB on 1/6/21 and progressively SOB worsened. 1/7/21 called in due to severity of symptoms and went to Urgent Care that day. TEsted + for STrep but negative for Covid. Other symptoms are cough, scratchy throat and low grade fever off and on (high was 100.4). On 1/8/21 employee went to ER for increased SOB. Tested negative again for Covid but had an elevated D-dimer. No diagnosis was given. Employee was discharged home. As of 1/11/21 still continues with SOB due to unknown etiology.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,amlodipine,Drainage and cold like symptoms that started 1/4/21.,High blood pressure,,Sulfa drugs,"['Cough', 'Dyspnoea', 'Fibrin D dimer', 'Nasopharyngitis', 'Pyrexia', 'SARS-CoV-2 test negative', 'Streptococcus test', 'Throat irritation']",2,PFIZER\BIONTECH,IM 934121,,33.0,F,"Fever, chills and body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,WRK,,,,,,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934122,OK,65.0,M,"Patient received first dose of Moderna vaccine on 1.8.21. Reported to urgent care on 1.10.21 and was diagnosed with shingles. Prescribed antivirals at that time. Today (1/11), bad headache, burning from shingles, and more joint pain than usual.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/10/2021,2.0,PVT,,,,,,"['Arthralgia', 'Burning sensation', 'Headache', 'Herpes zoster']",1,MODERNA,IM 934123,IN,34.0,F,"Fever of up to 102.9, chills, extreme headache, upper shoulder/lower neck pain. fatigue the next day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,UNK,"acyclovir, Mirena",,,12/19/2020,Erthromycin,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Neck pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934125,CA,27.0,F,"injection site redness and heat, hot to the touch",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/09/2021,6.0,UNK,,,,,,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,SYR 934126,VA,25.0,F,Excruciating joint pain in right shoulder and right hip. Sometimes left shoulder and hip hurt as well but mostly right side. Feels like arthritis. I can hardly move those extremities at times.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,"Lexapro 20mg, trazadone 50mg, Welbutrin 300mg, Clonazepam 0.5mg, symbicort, xopenex, metoprolol 25mg, montelukast 25mg, YAZ birth control pill.",None,"Asthma, depression, PTSD, anxiety.",,Milk,"['Arthralgia', 'Mobility decreased']",1,PFIZER\BIONTECH,SYR 934128,,39.0,F,"Intense joint pain. Worst in my elbows and shoulders Aching/burning sensation. Most Lasted 2 days, but still have some elbow discomfort 5 days after vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,"MVI, magnesium, vit. C, omeprazole",None,None,,N/a,"['Arthralgia', 'Burning sensation']",1,PFIZER\BIONTECH,IM 934129,,38.0,U,"Fever 104, bone pain, aches, shaky",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Bone pain', 'Nervousness', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934130,CA,37.0,M,"Chills, sweating, muscular aches lasting through the night and into next morning",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,none,none,none,,none,"['Chills', 'Hyperhidrosis', 'Myalgia']",1,MODERNA,IM 934131,ND,30.0,F,"Chills, body aches, nausea, @7pm to 12am Headache 12am till 10pm (",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Headache', 'Pain']",1,MODERNA,SYR 934132,FL,25.0,F,Injection site developed a red filled in circle all the way around it and was itchy,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/10/2021,8.0,WRK,"Flonase, Zyrtec",,,,Amoxicillin,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 934133,CA,49.0,M,Bad chills kept him away overnight.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/10/2021,01/11/2021,1.0,UNK,,,,,,"['Chills', 'Sleep disorder']",1,MODERNA,SYR 934134,MI,28.0,F,"Chills, headache, muscle aches, congestion, sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,Apri Levothyroxine,Bone,Hashimoto/hypothyroid,,None,"['Chills', 'Headache', 'Myalgia', 'Oropharyngeal pain', 'Respiratory tract congestion']",2,PFIZER\BIONTECH,IM 934135,VA,35.0,F,"I received the shot around 11am, and around 3am I woke up with a fever, sweating and chills. I was also experiencing a headache and body aches. My fever went down around 6am, but I was still experiencing severe body aches. The overall affect was similar to the flu. I took some over the counter medications to treat the fever and body aches (Advil and Tylenol) and began feeling better around noon.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Synthroid, Buspirone, Cymbalta, Fish oil, vitamin B12, vitamin D, Famotidine, Probiotic, Warfarin, Spironlactone, Artovostatin, Magnesium",,Sneddon's Syndrome History of CVA Hashimoto's,,Sulfites (wine/cider/beer),"['Chills', 'Headache', 'Hyperhidrosis', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934136,,27.0,U,"Fever, shaky, aches, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Headache', 'Pain', 'Pyrexia', 'Tremor']",2,PFIZER\BIONTECH,IM 934137,,,U,at midnight started chills fever nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/10/2021,01/10/2021,0.0,UNK,,,,,,"['Chills', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 934139,TX,58.0,F,"About a week post-vaccination, patient noticed a red dot around injection site that has increased in size daily. It is stiff and itchy, per the patient. She also complains of stomach pain that comes and goes- some so severe that the patient finds herself unable to eat. Patient was advised to place warm compress on the area as well as take antihistamine for symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,,,,,,"['Abdominal pain upper', 'Feeding disorder', 'Injection site erythema', 'Injection site pruritus', 'Musculoskeletal stiffness']",1,MODERNA,IM 934140,AK,49.0,F,Swollen lymph nodes on left arm still ongoing will be seeking medical care.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,SEN,Metformin ER 500mg BID Cholecalciferol 1000iu Lisinopril 20mg Pravastatin 20mg Premarin 0.625mg,,Type II Diabetes,,none,['Lymphadenopathy'],2,PFIZER\BIONTECH,IM 934142,PA,51.0,F,"Tingling up and down spine 24 hrs later next day mild tingling a change in sensation like cold up down spine resolved by the next day 28, December 2020. Felt body chills and feverish and fatigue . By 12/29/2020 felt fine. Last week had a lot of fatigue, and sleepiness varius. ER on Sunday, 12/27/2020 not concern though it to be a immune response.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,PVT,"Yes, Wellbutrin 300 mg, Gabatentin 300 mg, Crestor 10 mg, Vitamin D 200 mg daily, tylernol 500 mg",No,No,,No,"['Chills', 'Fatigue', 'Feeling cold', 'Paraesthesia', 'Pyrexia', 'Somnolence']",1,MODERNA,IM 934143,OK,72.0,F,"Received vaccine at 1:06pm. At 3:30pm felt something odd in my mouth. Looked and found left front side of my tongue was reddened and raw looking, no discomfort at all. Kept watching for last couple of days and today it seems alittle better but my doctor felt it should be reported. I do have a picture",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Warfarin Calcium Vit D Lipitor,None,"I have a clotting disorder, Protein S deficiency, diagnosed over 20 years ago",,Zomax Robaxin Biotin,"['Feeling abnormal', 'Glossitis', 'Tongue erythema']",1,MODERNA,IM 934144,IL,51.0,M,"I am a front line physician and got my first dose of Pfizer vaccine on 12/21/2020. For the first two days after the shot, I had only injection site soreness and mild headache, but nothing serious (Grade 1 effects). was able to go to work with that easily. On the tenth day (December 31, 2020) after dose 1 of Pfizer vaccine, I started to get severe myalgias, headache, chills, neck and back pain, mental fogging, malaise, altered taste, and fever spiking up to 101.2. I took Tylenol and tried to sleep. Woke up at 2 am with worst chills of my life, not improved my several blankets. My initial thought was that I have gotten COVID 19 before vaccine could take effect. I got 3 negative PCR tests done at hospital, first one on 1/2/2021 (day 3 of symptoms and day 13 after vaccine), second one on 1/5/2021 (Day 6 of symptoms and day 16 after vaccine), and third one on 1/8/2021 (Day 9 after symptoms and day 19 after vaccine). My symptoms are still persisting (today is Day 12 of symptoms and Day 22 after vaccine), but have slightly improved in last few days. I have not been able to do any activities of daily life (Grade 3). Have been taking Tylenol 3 times a day, bed rest, hydration. I have been the biggest supporter of the vaccines, but now totally unsure. I have talked to several ID and Immunology colleagues and nobody can explain it. I reviewed Pfizer EUA document, and on page 41, a subset of people have been described who had COVID type symptoms but negative tests. May be I have a n atypical delayed and prolonged systemic reaction to dose 1. I have decided not to take the Dose 2 and wait for a more traditional vaccine like Jonson and Johnson.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/31/2020,10.0,PVT,"Hydrocholorothiazide, Losartan, Atorvastatin, baby aspirin",,Hypertension. Obesity (BMI 36),,mild seasonal allergies; mild allergies to sulfa medicines,"['Back pain', 'Chills', 'Confusional state', 'Headache', 'Injection site pain', 'Loss of personal independence in daily activities', 'Malaise', 'Myalgia', 'Neck pain', 'SARS-CoV-2 test negative', 'Taste disorder']",UNK,PFIZER\BIONTECH,IM 934145,MN,45.0,F,"Severe diaphoresis following the immunization. Occurred in waves, about 5 times throughout the day at work. Face turned red, needed to change her clothes the sweating was so bad.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Imitrex Verapamil,,None,,,"['Erythema', 'Hyperhidrosis']",1,PFIZER\BIONTECH,IM 934146,NH,34.0,F,Developed baseball sized hive and swelling about an inch or more below the injection site along with lymph node swelling on the right side only. Ibuprofen and Benadryl were taken and hot and cold compresses were used to help alleviate the pain and swelling.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/09/2021,5.0,WRK,None,Positive test for covid 19 antibodies,,,"Doxycycline, macrobid, Penicllin, thimerosal","['Injection site swelling', 'Injection site urticaria', 'Lymphadenopathy']",1,MODERNA, 934147,OH,41.0,F,"Patient developed an itchy rash on her arms and stomach the day after receiving this vaccine. She took Benadryl for two days, and it was gone. She had no other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,SEN,,,,,,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 934149,PA,34.0,F,"Within 45 minutes of vaccination - developed red face with tingling; recipient felt ""extremely warm"". Patient was medicated with Benadryl 100mg and felt fine after a short period of time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,,,,,,"['Erythema', 'Feeling hot', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 934150,IN,31.0,F,Hot flashes Cold chills Headache Body aches Fatigue Dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PUB,Probiotic Vitamin D3 Diltiazam Cymbalta Estradiol Xyzal Protonix Pravastatin Progesterone,Non,Chronic gerd Depression Hypertension Hyperlipidemia Premature ovarian failure,,Benadryl,"['Chills', 'Dizziness', 'Fatigue', 'Feeling cold', 'Headache', 'Hot flush', 'Pain']",UNK,PFIZER\BIONTECH, 934151,NE,62.0,F,"ON 12/31/20 AT 1PM, DEVELOPED SORENESS AT INJECTION SIGHT, GREATER THAN NOTICED WITH OTHER VACCINATIONS. LASTED 48-72 HOURS. ALSO HAD HEADACHE, WHICH WAS PRESUMED TO BE SINUS HEADACHE, BUT DID NOT RESPOND TO SINUS MEDICATION. HEADACHE CONTINUED THRU 1/1/21 WITH NAUSEA ALSO NOTED. SYMPTOMS SUBSIDED BY 1/2/21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,SEN,,,,,,"['Headache', 'Injection site pain', 'Nausea', 'Sinus headache']",1,PFIZER\BIONTECH,IM 934152,OR,32.0,F,"1/8 Friday: Developed sore arm and body aches about 3 hours after injection. 1/9 Sat: Worsening of arm soreness, body aches, Temp 100.6F 1/10: Sun: Arm soreness much improved, lingering pain to touch. No body aches or fevers. Overall felt well. 1/11 Mon: awakened with rash all over upper body (chest, back, upper arms), worse around injection site. It is itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/11/2021,3.0,WRK,prenatals,none,ulcerative proctatis,,none,"['Body temperature increased', 'Injection site rash', 'Pain', 'Pain in extremity', 'Pruritus', 'Rash', 'Tenderness']",1,MODERNA,IM 934153,OR,41.0,F,"I had my first COVID 19 Moderna vaccine Lot: 025J20-2A at hospital. Within about 60 seconds of receiving it, my heart started pounding hard and rapidly and I let a nurse know. She took my vitals and my heart rate was very high, as was my blood pressure. My O2 was fine. I had some tightness and heaviness I my chest. I felt flush in my cheeks, but did not have hives. The nurse said my color was very pale. I was warm, given an ice pack, and then a bit later cold. At one point they wanted me to go to the Emergency Department, which I refused (perhaps stupidly). I'm not sure I was thinking clearly. I was trying very hard to stay calm and relaxed. My blood pressure was very elevated for about an hour and a half. They finally let me go home when I was 140/95 (my usual is 110 over 70 ish). I had some tongue tingling at home, very briefly.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,Retin A topical face cream Vitamin D B2 COQ10 Omega 3s Calcium supplement,none,asthma (mild); migraines,,none,"['Chest discomfort', 'Confusional state', 'Feeling cold', 'Flushing', 'Heart rate increased', 'Hypertension', 'Pallor', 'Palpitations', 'Paraesthesia oral', 'Skin warm']",2,MODERNA,SYR 934154,KS,43.0,F,"Arm that received the injection was sore and tender to touch from time of injection. Major headache/slight migraine occurred about 8 hours after injection. Not sure if related or not? 12 hours after shot, injections site became slightly raised and red, warm to the touch and very tender to the slightest touch or exaggerated movement. This lasted 2 days. Day 3, swelling and redness are are gone but is still slightly tender when pressure is applied to injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,Levothyroxin 25 mcg tab Sertraline HCl 100 mg tab Mirena,None,None,,None,"['Headache', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Migraine', 'Pain', 'Pain in extremity', 'Pain of skin']",1,MODERNA,SYR 934155,GA,50.0,F,Fever 99.4-100.6 for 3 days after mild headache and body aches now resolved,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,WRK,Hydroxychloroquin Tizanidine Meloxicam,none,Sjogrens Fibromyalgia Arthritis Migraines,,none,"['Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,IM 934156,IN,60.0,F,"01/06/21 at 6 pm, body aches, and chills 01/07/21 at 12am T102.2, SPO2 62% on room air. Was sent to ER and returned. 01/08/21 at SPO@ less then 60% on room air, non responsive to verbal tactile stimuli. Responsive to sternal rub only. Was sent to ER and admitted to ICU.",Not Reported,,Yes,Yes,3.0,Not Reported,U,01/05/2021,01/07/2021,2.0,SEN,"Tylenol, Atenolol, LIpitor, Clonidine, mutlivitamin, Lasix, Gabapentin, Losartan, Maalox, Miralax, Zofran, Vitamin D2.",No,"2019-nCoV acute respiratory disease, Hyperlipidemia, unspecified, Chronic obstructive pulmonary disease, unspecified, Other hereditary and idiopathic neuropathies, Essential (primary) hypertension, Peripheral vascular disease, unspecified, Venous insufficiency (chronic) (peripheral), Other chronic pain, Type 2 diabetes mellitus with hyperglycemia, Dehydration, Nondisplaced oblique fracture of shaft of left fibula, sequela, Vitamin D deficiency, unspecified, Nondisplaced fracture of second metatarsal bone, left foot, subsequent encounter for fracture with routine healing, Nondisplaced fracture of third metatarsal bone, left foot, subsequent encounter for fracture with routine healing, Nondisplaced fracture of fourth metatarsal bone, left foot, subsequent encounter for fracture with routine healing, Hypokalemia, Acute respiratory failure with hypoxia, Muscle weakness (generalized), Difficulty in walking, not elsewhere classified, Cognitive communication deficit, Non-pressure chronic ulcer of other part of left lower leg with fat layer exposed, Repeated falls, Cellulitis of right lower limb, Cellulitis of left lower limb, Other iron deficiency anemias, Other recurrent depressive disorders, Hypothyroidism, unspecified, Chronic venous hypertension (idiopathic) with ulcer of bilateral lower extremity, Diabetes mellitus due to underlying condition with other skin complications, Other constipation, Chronic respiratory failure with hypoxia, Other acute kidney failure, Lymphedema, not elsewhere classified, Generalized edema, Morbid (severe) obesity due to excess calories, Chronic ischemic heart disease, unspecified, Gastro-esophageal reflux disease without esophagitis, Disorder resulting from impaired renal tubular function, unspecified, History of falling, Cellulitis/abscess, leg, Impaired renal function NOS, Hypertension, benign essential",,"Bactrim, Kefles, PCN","['Chills', 'Intensive care', 'Laboratory test', 'Pain', 'Unresponsive to stimuli']",1,MODERNA,IM 934157,TN,50.0,M,"On 01-07-2021, I tested positive to Covid. I had a very mild runny nose, stuffy nose and hands feel cool to touch. My oxygen Stats are stable. My son had covid exposure from his employer and he did not get treated. My son and wife did not believe in Covid. I wore a mask throughout my home and sanitized all my areas.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/07/2021,14.0,PUB,"Metformin 500mg OD, Vistolic 5mg OD, HD 800mg OD, Remectate (immuno therapy) 950mg IV once every 8 weeks ( last received Dec 17 2020)",None reported (only have a pre-existing health condition due to nephrectomy),"Bilateral kidney survivor, diabetes",,None reported,"['COVID-19', 'Peripheral coldness', 'Rhinorrhoea']",1,MODERNA,IM 934159,,78.0,M,Patient with basil artery occlusion approximately 1 day after receiving COVID vaccine dose #2.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/10/2021,2.0,UNK,,,,,,['Basilar artery occlusion'],2,PFIZER\BIONTECH,IM 934160,CA,26.0,F,"left arm and leg weakness, nausea, dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,SCH,no,no,no,,"gabapentin, ondansetron","['Dizziness', 'Muscular weakness', 'Nausea']",1,MODERNA,IM 934161,IL,46.0,F,"Headache, malaise, fatigue, dizziness, weakness, chills and hot flashes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,"Vitamin D, Biotin, Hydrochlorothiazide, Rosuvastatin, Metformin, Naproxen, Gabapentin and Escitalopram",None,"Pre-diabetes, hypercholesterolemia, hypertension, migraines, chronic back pain and anxiety/depression",,"Doxycycline, Tetracycline","['Asthenia', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Hot flush', 'Malaise']",1,PFIZER\BIONTECH,IM 934162,OR,,M,"1/10 I started feeling ill. Abdomen feeling sore. I have burning in my ears throat swelling, dizzy, feels like I have a fever, Feel out of it, lock jaw , hard to stand/ walk Nauseous. I called the COVID hotline and no answer.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/10/2021,2.0,PUB,"gabapentin, patoprazole, diloxitine, anitriptoline, avostatin, seroquel, metopolol, lexapro, asa, hydroxizine, tixanditine, nitroglycerin, novolog, trulicity, mealotonin,tresiba,",no,"diaibetes, nerupathy, copd, amputaion",,"lantius, metformin, hydocodine","['Abdominal pain', 'Burning sensation', 'Dizziness', 'Dysstasia', 'Feeling abnormal', 'Gait disturbance', 'Malaise', 'Nausea', 'Pharyngeal swelling', 'Pyrexia', 'Trismus']",1,MODERNA,SYR 934163,RI,50.0,F,"I had the vaccine on Dec 28. I had some expected arm pain in the left arm where I had received the vaccine. About 1 week later, I noticed the upper left arm was itchy and continued to itch throughout the week. On Jan 10, I noticed a large red area on the side and back of the left upper arm. The area was warm and felt slightly swollen. The center of the area was clear and the edge was red. The area continues to be itchy, but there is no pain or decreased in function of the left upper arm. Since January 10, I have been using over the counter Cortisone cream, which helps the itching temporarily.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,WRK,Lisinopril Lipitor Lexapro Focalin XR Claritin One a Day multivitamin Fish Oil,none,"mild hypertension hypercholesterolism dysthymia, anxiety, ADHD allergies to pollen, mold, ragweed - environmental allergies",,none,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 934166,SC,45.0,F,Recently tested positive for Covid 19 with a BIO IQ home test kit provided by my employer. Test performed 1/7/2021 and was reported positive 1/9/2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,01/07/2021,17.0,PVT,Prozac 40 Zyrtec 10 Mirapex 0.5,None,Seasonal Allergies and sinus,,Seafood Latex Betadine,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 934167,PA,34.0,F,"Within 45 minutes of receiving the vaccine - red face with tingling; recipient got ""extremely warm"". Resolved quickly once patient received Benadryl 100mg.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,,,,,,"['Erythema', 'Feeling hot', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 934168,,32.0,F,"The morning after the vaccine, I had soreness and mild fatigue. The soreness and stiffness was greatest in the arm of injection, and was less intense but present in my upper back and neck. This soreness and stiffness lasted the whole day after the vaccine but was becoming milder, until day 2 after the vaccine when it had completely resolved. No medications were required. Day 1 after vaccine I also had a bright red, flat, rash that appeared as very close small circles near the injection site (where the bandage was placed) but not on the actual vaccine site. No itching, spreading of rash, or other symptoms. This resolved day 2. I have no known allergies to bandages at this time. No medications were required.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,minastrin 24 FE,none,none,soreness of arm after each yearly flu vaccine,no,"['Back pain', 'Fatigue', 'Injection site rash', 'Musculoskeletal stiffness', 'Neck pain', 'Pain in extremity', 'Rash erythematous']",1,MODERNA,IM 934169,GA,27.0,F,"Vaccine: 12/30/2020 0900 AM Symptoms started: 12/30/2020 0925 AM Symptoms: tachycardia 150s, weakness, feeling extremely hot, lip and facial numbness, tightness on throat, difficulty swallowing, shortness of breath Duration: 1 hour Frequency post vaccination: QDAY but less severe ED Visit: 12/31/2020 prescribed Zyrtec and Pepcid Symptoms still occurring going on week two post vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,Lo loestrin fe,None,None,,No known allergies,"['Asthenia', 'Dysphagia', 'Dyspnoea', 'Feeling hot', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Tachycardia', 'Throat tightness', 'Vital signs measurement']",1,PFIZER\BIONTECH,IM 934170,VA,54.0,F,Developed chills and rigors lasting approximately 15 minutes. Followed by fatigue also had arm pain at injection site which subsided after episode of rigors.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,WRK,"metformin, vitamin d, naprosyn",none,"diabetes, dyslipidemia, vitamin d deficiency",,none,"['Chills', 'Fatigue', 'Injection site pain']",1,PFIZER\BIONTECH,IM 934171,OH,39.0,F,Severe headache 6 days after vaccine was administered,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/10/2021,6.0,PVT,Levothyroxine Metoprolol L-methylfolate CoQ10 Quercetin,none,Hypothyroidism History of breast cancer Chemo related cardiomyopathy,"large local reaction to flu shot (arm redness, swelling, itching and tenderness)","Latex (rash) Vancomycin (itching, flushing) Gadolinium (hives, throat tightening)",['Headache'],1,MODERNA,IM 934172,NE,21.0,F,"ON 1/1/21 AT 1PM, DEVELOPED A SEVERE MIGRAINE WITH ON/OFF NAUSEA AND DIARRHEA. LASTED 14 HOURS BEFORE RESOLVING",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,SEN,,,,,,"['Diarrhoea', 'Migraine', 'Nausea']",1,PFIZER\BIONTECH,IM 934173,,53.0,F,"Patient experience chest pressure, increased blood pressure within 10 minutes of receiving COVID vaccine dose #2. H/O Myasthenia gravis and experienced exacerbation of myasthenia gravis.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,01/11/2021,0.0,UNK,,,,,,"['Blood pressure increased', 'Chest discomfort', 'Condition aggravated', 'Myasthenia gravis']",2,PFIZER\BIONTECH,IM 934174,UT,52.0,U,"developed swollen gland, Dizziness and headache. Had client go to Dr and he gave her steroids, he will follow her and see if he feels she should receive her 2nd dose",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,"Synthroid, Parapropazol, verapamil,",none,,,"ASA, Sulfa, Clomed, Metforman","['Dizziness', 'Headache', 'Lymphadenopathy']",UNK,MODERNA,IM 934175,PA,56.0,F,"Experienced vertigo, nausea, vomiting headache after awaking at approximately 6:00am on 6/7/21. Outreached PCP and was advised that these events were side effects experienced by some after receiving vaccine. Ibuprofin was recommended along with rest, fluids, eating small meals, monitoring of symptoms, and was advised by NP for my PCP that symptoms/side effects normally remedy in 24 to 48 hours. On the evening of the 48th hour, 1/8/21, after other symptoms had cleared, I began experiencing constant ringing in my left ear and some wobbliness, this continues today 1/11/21. Called Urgent care and was advised there is nothing they can do for such symptoms and was advised to continue to receive guidance from PCP. Am currently awaiting call back from PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,"Vitamins: B12, Multivitamins, Turmeric, Zinc, D3, Magnesium, Iron supplement.",Prediabetic.,None known.,,Hx of allergic reaction to some unidentified food products in the past.,"['Balance disorder', 'Headache', 'Nausea', 'Tinnitus', 'Vertigo', 'Vomiting']",UNK,MODERNA,SYR 934176,NJ,57.0,F,Hives at injection site 8 days after injection followed by 2 days of redness and intense itching.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,01/06/2021,8.0,OTH,Wellbutrin XL Singulair,None,Asthma,,PCN,"['Injection site erythema', 'Injection site pruritus', 'Injection site urticaria']",1,MODERNA,IM 934177,LA,47.0,F,"Bodyache , chills, Diarrhea , headache , fatigue , was tested for Covid on the 28th and was confirmed positive",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/22/2020,1.0,PVT,Yaz- Birth control flonase nasal spray (unknown),None,asthmatic,,None,"['COVID-19', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 934178,FL,51.0,F,"DIZZINESS, HEADACHE AND TOTAL EXHAUSTION FOR 2 DAYS.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,NONE,,NON CAD,,NONE,"['Dizziness', 'Fatigue', 'Headache']",1,PFIZER\BIONTECH,IM 934179,FL,25.0,F,"Approximately 3-4 hours after getting the vaccine she experienced every symptoms possible, hit her all at once. Felt like every part of her body was breaking and being stabbed. Severe pain. Fever, chills, abdominal pain, back and neck pain. Chest pain, felt like she was losing consciousness. Was in ED until next day Saturday discharged around 7 am. Had morphine, Benadryl and Toradol while in ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,none,None,"Heart condition- LGL syndrome with syncope, autonomic dysfunction disorder, hemangioma benign tumor on spine",,None,"['Abdominal pain', 'Back pain', 'Chest X-ray', 'Chest pain', 'Chills', 'Dizziness', 'Electrocardiogram normal', 'Feeling abnormal', 'Neck pain', 'Pyrexia', 'White blood cell count increased']",1,MODERNA,IM 934180,ME,29.0,F,"Severe fever (104.6), chills, nausea, fatigue, muscle soreness for 36 hours and ongoing.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934181,NE,21.0,F,"ON 1/1/21 AT 1PM, DEVELOPED SEVERE MIGRAINE, WITH ON/OFF NAUSEA AND DIARRHEA LASTING 14 HOURS BEFORE RESOLVING.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,SEN,,,,,,"['Microalbuminuria', 'Nausea']",1,PFIZER\BIONTECH,IM 934182,IL,46.0,F,"Migraines, body ache, malaise, fatigue, weakness, chills, hot flashes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Vitamin D, Biotin, Hydrochlorothiazide, Rosuvastatin, Metformin, Naproxen, Gabapentin and Escitalopram",None,"Pre-diabetes, hypercholesterolemia, hypertension, migraines, chronic back pain and anxiety/depression",,"Doxycycline, Tetracycline","['Asthenia', 'Chills', 'Fatigue', 'Hot flush', 'Malaise', 'Migraine', 'Pain']",1,PFIZER\BIONTECH,IM 934184,IN,50.0,F,Chills Body aches Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,UNK,Bp med Cbd oil Protonx Condifer,,,,,"['Chills', 'Fatigue', 'Pain']",UNK,PFIZER\BIONTECH, 934185,VA,21.0,F,"Felt weak, nauseated and dizzy. Initial bp 96/59; had recipient lay down and wait longer. bp up after 15 minutes to 107/75",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,01/11/2021,0.0,PVT,,,,,,"['Asthenia', 'Dizziness', 'Nausea']",1,PFIZER\BIONTECH,IM 934186,CA,46.0,F,"I woke up early in the morning day after the vaccine with extreme dizziness, ataxia and nausea. Mild headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PUB,,,,,Sulfa,"['Ataxia', 'Dizziness', 'Headache', 'Nausea']",1,MODERNA,IM 934187,OH,24.0,F,"Severe abdominal pain, vomiting, nausea, fever, chills starting at 5am continuing through the day. IV fluids and zofran administered at 2pm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,WRK,Zoloft 50mg daily,None,No e,,"Sulfa, pcn, pineapple, citrus","['Abdominal pain', 'Chills', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 934188,AL,48.0,F,"Fever up to 100.8 off and on, the day following the injection, chills, slight nausea, pain injection site, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,OTH,Sertraline,None,None,,None,"['Chills', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia']",UNK,MODERNA, 934189,FL,36.0,F,"Immediately follow injection patient's heartrate went to 119 and patient felt panic/possible short of breath, patient was allowed to go outside to remove mask. Heart rate increased to 163. Patient was allowed to leave as she felt fine other than the high heart rate. Rate went down to 84-91 while driving home from 4:41 to 4:59 and then it increased again to 166 and came down to 102 by 5:01. No other issues that night. The following 3 days patient had periodic increases in heartrate while at rest to 161 on Thursday, 158 on Friday along with chest tightness and ""feeling off"", and Saturday 172. Patient also had lower back pain on Thursday and mild fatigue on the 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"""Ritual"" brand multi-vitamin",none,none,,none,"['Back pain', 'Chest discomfort', 'Fatigue', 'Feeling abnormal', 'Heart rate increased', 'Immediate post-injection reaction', 'Panic disorder']",1,MODERNA,IM 934190,IL,21.0,M,Patient reports feeling nauseous and experiencing extreme pain at injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2020,01/06/2021,371.0,PUB,vitamin c supplements,none,none,,none,"['Injection site pain', 'Nausea']",1,MODERNA,IM 934191,NY,26.0,F,"Vaccine administered at 10:30am syncopal episode x30 seconds with small amount of emesis at 10:46am. Patient monitored by EMS and MD. Vitals were initially BP 80/50 HR 60, then BP 110/70 HR 80, then BP 110/78 HR 70. By 11:05am patient was feeling better and sent home in a private vehicle driven by her parent. Water and juice provided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PUB,None,None,None,,None,['Syncope'],1,MODERNA,IM 934192,PA,51.0,F,"Tingling up and down spine next day mild tingling a change in sensation like cold up down spine, resolved that day. Had and body aches, fatigue and past server few weeks of extreme fatigue, felt feverish of chills. Went to the ER on 12/27/2020 and they thought it was a immune response, but did not feel concern about it.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,WRK,"Wellbutin 300 mg, Gabatindin 600mg, Tylernol 500mg, Vitiamin D 200mg",No,No,,No,"['Chills', 'Fatigue', 'Feeling cold', 'Immunisation reaction', 'Pain', 'Paraesthesia', 'Pyrexia']",1,MODERNA,IM 934193,OH,35.0,F,"Received the vaccine 1/8/21 at 4:45pm, the next day had a sore arm and was tired. Woke up Sunday at 4:37am to take some ibuprofen for my arm pain and didn't get to take the meds, I had a seizure the meds and my glass were all over the floor. I never even felt it coming on, I just remember waking up. I looked at the clock at 4:46am. It seemed like a very long time to be out. When I woke up I felt very nauseas and had a hard time getting up to go to the bathroom. I never did get sick but laid down and fell asleep immediately. I slept all day Sunday. Today, Monday 1/11/21, I am still exhausted and light headed but not as nauseas.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/10/2021,2.0,OTH,Daily Multi Vitamin,none,epilepsy as a child from 2-12 years old. I was on Taggertol as medication. Last known seizure was Sunday 1/10/21 at 4:37Am prior to that was 8 years ago. Not cureently on any meds and do not see a neurologist. Not need after the age of 12.,,none,"['Dizziness', 'Fatigue', 'Pain in extremity', 'Seizure']",1,MODERNA,SYR 934194,CA,47.0,M,Lymphadenopathy in same arm as vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/10/2021,2.0,PVT,"Metformin, Glipizide, Losartan, Jardiance, Atorvastatin, Ibuprofen",none,DM,,None,['Injection site lymphadenopathy'],2,PFIZER\BIONTECH,IM 934195,IA,39.0,M,"Fevers, chills, headache, myalgias, loss of taste and smell, nasal congestion. I tested positive for Covid-19 on 1/1/21. Again, I later found out that I was exposed to someone who tested positive on 12/24/20 and at the time did not have a mask on.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,None,Later found out exposed to COVID + individual 4 days prior to vaccination.,None,,None,"['Ageusia', 'Anosmia', 'COVID-19', 'Chills', 'Headache', 'Myalgia', 'Nasal congestion', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 934196,CA,45.0,F,Felt weak runny nose fever chills body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,UNK,,,,,,"['Asthenia', 'Chills', 'Pain', 'Pyrexia', 'Rhinorrhoea']",1,MODERNA,SYR 934197,IL,39.0,F,"Lower back pain, fever, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,Birth control,Covid -19,None,,None,"['Back pain', 'Fatigue', 'Pyrexia']",2,PFIZER\BIONTECH, 934198,MI,46.0,M,"Joint swelling and pain. Areas affected bilateral hips and shoulders, and lumbar. States pain level 7-8. Received vaccination on Thursday 1/7/2021 at 3pm and symptoms started when he woke up on Friday morning 1/8/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PUB,Vitamin C,None,None,,Aspirin (stomach issues),"['Arthralgia', 'Joint swelling']",1,MODERNA,IM 934199,WA,26.0,F,"C/O DIZZINESS, LIGHTHEAD, RACING HEART, 810PM 90/50,77, 99% GIVE H2), 815PM SLIGHT IMPROVEMENT, 820PM NO SYMPTOMS LEFT AT 840PM,905PM RETURN TO VACCINE SITE DIZZINESS/LIGHTHEADED 90/58,64, 99% H2O, 929PM NO DIZZINESS/LIGHTHEAD FRIEND DROVE,01/8 VM&PCP",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,none,none,unknown,,none,"['Dizziness', 'Palpitations']",1,MODERNA,IM 934200,CT,67.0,F,"pt hx of allergies/medications -- 30 min after injection, redness flushed face, cheeks and forehead, slight swelling on left side face- tingling. Injection site soreness. Benadryl 25mg dose. 1/11/2021 symptoms have resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Metoprolol 50mg, Synthroid 50mcg, Chlorthalidone 25 mg, Potassium, Multivitamin, Collagen, Zinc 50mg, Vitamin C, Vitamin D",,"Hypothyroidism, Ventricular tachycardia, Asthma","Afluria Quad 2020-2021, fast resting heart rate 09/29/2020, Lot number: P100253275","Erythromycin, mycin family, Ultram, motrin generic brand, Angiotensin-converting enzyme (ACE) inhibitors","['Erythema', 'Flushing', 'Injection site pain', 'Paraesthesia', 'Swelling face']",1,MODERNA,IM 934201,,49.0,F,"Got shot waited 15 minutes, walked to elevator, felt dizzy returned to vaccine admin area. Headache, vitals checked and were okay. Continued to feel weird rubbing chest and short of breath but no chest pain. Decided to take her to the ED. On the way she passed out and was not responsive still had a pulse. In ED became responsive, reports numbness in both arms and short of breath. Received Benadryl complete assessment, doesn't appear to be an acute allergic reaction. ECG & vitals were okay. Patient observed for 4 hours and seemed to improve so discharged.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,swollen eyes from flu shot,,"['Dizziness', 'Dyspnoea', 'Electrocardiogram normal', 'Feeling abnormal', 'Headache', 'Hypoaesthesia', 'Loss of consciousness', 'Unresponsive to stimuli']",1,MODERNA,IM 934202,LA,73.0,M,Sinus discharge weakness. Feels like a cold.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/11/2021,2.0,PVT,Entresto Pantoprazole Cardevilol Spironolactone,,Heart failure Asthma,,,"['Asthenia', 'Nasopharyngitis', 'Paranasal sinus hypersecretion']",1,PFIZER\BIONTECH, 934203,WV,54.0,F,"5 Minutes after shot in this order -1st - pain and swelling of lymph nodes in the right side of the neck 2nd - body began feeling hot 3rd - felt dizzy like I was going to pass out 4th - A little upset at my stomach All happened within a minute of each other. The feeling of being hot and dizziness went away within an hour Nausea has come and gone over the last 48 hours. Neck pain and swollen lymph nodes in neck stayed for about 48 hours. 36 hours AFTER injection, the lymph nodes in my right armpit began to hurt and swell. 72 hours after the shot, nodes in the right armpit still hurt, but hurt less than the day before.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,WRK,none,none,none,,Sulfa Drugs and Morphine,"['Abdominal discomfort', 'Dizziness', 'Feeling hot', 'Lymph node pain', 'Lymphadenopathy', 'Nausea', 'Neck pain']",1,MODERNA,SYR 934204,NE,54.0,F,"ON 12/31/20 IN THE MORNING, DEVELOPED CONGESTION AND MILD SORE THROAT. ALSO, JOINT PAIN IN THE HANDS. LOW GRADE FEVER WITH ONSET ON 1/2/21 WHICH RESOLVED 1/3/21. STATES JOINT PAIN CONTINUES",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,SEN,,,,,,"['Arthralgia', 'Oropharyngeal pain', 'Pyrexia', 'Respiratory tract congestion']",1,PFIZER\BIONTECH,IM 934205,NJ,60.0,M,"Moderate pain (4 on 1-10 scale) upper R. deltoid, persisted for approx. 36 hours. Not tender to touch. Pain was sensitive to movement and somewhat restricted movement of R. shoulder for a while. Not considered serious by patient. Pain was fully gone 48 hours post injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Losartan, Metformin, Januvia, OTC Vit. D, OTC Vit. B, OTC Glucosamine/Chondroitin",None; recent NEGATIVE COVID-19 test (Jan. 6),"Pre-diabetes, hypertension","Mild, short illness from seasonal flu, last observed > 10 years ago",NKDA No food allergies,"['Injected limb mobility decreased', 'Injection site pain', 'Pain']",1,MODERNA,IM 934208,TX,37.0,F,Got sick on Christmas Day 25th- low grade fever/aches; diarrhea; went on to have shortness of breath and some runny nose and congestion and a lot of fatigue 27th. Went to urgent care - was really tired; runny nose and congestion; Covid test was positive. Regenerome - On the 30th. Tylenol and Ibuprofen.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/25/2020,3.0,WRK,Levothyroxine 100 mg a day; Amlodipine 10 mg; Singular 10 mg /day; a multi-vitamin and calcium supplement; vitamin c,no,hyper tension and hyperthyroidism,,no,"['COVID-19', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Influenza virus test', 'Pain', 'Pyrexia', 'Respiratory tract congestion', 'Rhinorrhoea', 'SARS-CoV-2 test', 'Streptococcus test']",1,PFIZER\BIONTECH,IM 934209,NY,53.0,F,Lymphadenopathy axilla,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,WRK,Triameterene/HCTZ,Hypertension,Hypertension,,None,['Lymphadenopathy'],1,MODERNA,IM 934210,MO,42.0,F,excessive pain and swelling in cheeks where dermal HA filler was placed in 2017 (Volluma-2 year longevity) right> left,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,PVT,Lexapro 10mg daily Zantac 20mg daily,none,none,,Clindamycin,"['Facial pain', 'SARS-CoV-2 test negative', 'Swelling face']",1,MODERNA,IM 934211,TX,38.0,F,fatigue achy on 1/8 and nausea x 1 hour and redness at the injection site on 1/10. Pedialyte with improvement of symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Fatigue', 'Injection site erythema', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 934212,AZ,60.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,01/22/2021,11.0,PVT,,,,,,['Unevaluable event'],UNK,PFIZER\BIONTECH, 934213,,32.0,F,Chills and body aches about 12 hours after vaccine. These symptoms lasted one day. Acetaminophen helped with symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,UNK,Daily multivitamin,,,,,"['Chills', 'Pain']",2,PFIZER\BIONTECH,IM 934214,VA,53.0,F,"At 8:00 pm, approximately 36 hours after my second COVID - 19 vaccine injection in my left deltoid, my left upper lip began swelling. I took a Benadryl as I was already on prednisone. I had no problems during the night except a stuffy nose. On the following morning my face was swollen, more on the left. I took two more Benadryl during the day and on Sunday morning the swelling was gone. I had not other symptoms or complications.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Methotrexate; Plaquenil; prednisone; folic acid; Neurontin; Atacand; Lipitor; Celexa; Dexilant; Pepcid; Vitamins E, C, D; MVI; Magnesium; Biotin; Calcium; Tylenol; Prempro; Diosmin; Allegra",None,Scleroderma; Sjogren's; fibromyalgia; seasonal allergies; PVD; hyperlipidemia,,Macrobid; Tetracycline; Zithromax; Lortab,"['Lip swelling', 'Nasal congestion', 'Swelling face']",2,PFIZER\BIONTECH,IM 934215,TX,25.0,F,Hives all over the body,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/10/2021,11.0,SCH,Birth control,None,None,,Shellfish,['Urticaria'],1,MODERNA,IM 934217,IN,50.0,F,"broke out on face, neck and chest area",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"B12 shot, VitD vitamin",None,None,,"penicillin, Sulfa drugs",['Unevaluable event'],1,MODERNA,IM 934218,MO,31.0,F,"Increased swelling and pain in underarm on side of injection. Injection was about at 0800 on 1/9, pain began around 1900 1/9 and woke up with swelling and worsening tenderness on 1/10 at 0800. Swelling and pain continued into 1/11 and has not improved. No palpable lymph nodes",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,"Nortriptyline, melatonin, benadryl",,Migraines,,hives with amoxicillin,"['Axillary pain', 'Lymph node pain', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 934219,MD,40.0,F,"The day after the injection she noticed swelling in her right axilla that is painful but no redness. She also had one day of headache, chills and joint pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,,,,,,"['Arthralgia', 'Axillary pain', 'Chills', 'Headache', 'Swelling']",1,PFIZER\BIONTECH,IM 934220,CA,26.0,F,"left arm and leg weakness, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,SCH,no,no,no,,"gabapentin, ondansetron","['Hemiparesis', 'Nausea']",1,MODERNA,IM 934221,KY,29.0,F,"pt developed immediate (within minutes) redness of face; redness extended to arm and to neck, back of neck and now is concentrated on front of neck with an area of dry skin on temple; the areas affected burned for several hours;",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,mirena horizant singulair wellbutrin methadone,hypothyroidism,seasonal allergies restless leg syndrome periodic limb movement disorder pt has tattoos on lower left arm,,neupro (adhesive gives a bad rash) neoprene (binder in gloves) nitrile gloves vinyl gloves lavender lanolin,"['Dry skin', 'Erythema', 'Immediate post-injection reaction', 'Skin burning sensation']",1,MODERNA,IM 934222,CA,69.0,F,"1/10/2020 Left deltoid area of injection became itchy, red, warmth and welts appeared, small soft mass 2 by 3 cm. Next morning still have soft mass, red and warm with itching. No fever or swollen lymph nodes.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/10/2021,10.0,PVT,Prozac Vitamin D3 Multiple Vitamin B complex and Folate,none,depression,,levaquin,"['Injection site erythema', 'Injection site mass', 'Injection site pruritus', 'Injection site warmth', 'Urticaria']",1,MODERNA,IM 934223,ME,31.0,M,"Primary Diagnosis is likely hypersensitivity Reaction, or possible very early mild cellulitis caused by Vaccine around site area.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/08/2021,7.0,WRK,"Naproxen, Pantoprazole.",None,"Sleep APNEA, GERD,",,NKDA,['Injection site hypersensitivity'],1,MODERNA,IM 934224,IL,,F,after rcvd 2nd vaccination that evening I noticed that I was fatigued. All of a sudden i started getting a headache Pressure ( light) and seeing spots. 20-45 minutes later I started feeling better,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,WRK,famoditine,no,,,"penicillin, latex, sulfa, iodine","['Fatigue', 'Head discomfort', 'Headache', 'Visual impairment']",2,PFIZER\BIONTECH,SYR 934225,NY,58.0,F,"redness and warmth 10 days post injection distal to the injection site. PCP recommended cold compresses and 7 days of antibiotics. Warmth is decreasing, redness remains",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/09/2021,10.0,PVT,"Synthroid, exemestane, atorvastatin daily, multivitamins occasionally","sinus infection, virus with dyspnea on exertion resolved 2 weeks prior to vaccination","breast cancer, hypothyroid, high cholesterol",,"Codeine, Penicillin, Bactrim, Vancomycin","['Injection site erythema', 'Injection site warmth']",1,MODERNA,IM 934226,IL,58.0,F,Patient c/o redness and swelling at injection site greater than 6 inches in circumference. Reported feeling feverish and measured fever on 1/6/21 at 101.6 F and 100.6 on 1/8/21. States she went to the emergency room where she was diagnosed with cellulitis and prescribed an antibiotic for which can cannot remember the name of.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PUB,"Prilosec, one tablet once a day.",none,none,,none,"['Cellulitis', 'Injection site erythema', 'Injection site swelling', 'Pyrexia']",1,MODERNA,IM 934227,MI,41.0,M,1. Lethargy 2. Intense Migraine 3. Joint pain 4. Foggy Brain 5. Heavy Chest 6. Chills,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PUB,Wellbutrin,None,None,,None,"['Arthralgia', 'Chest discomfort', 'Chills', 'Feeling abnormal', 'Lethargy', 'Migraine']",UNK,PFIZER\BIONTECH,IM 934228,CA,32.0,F,Patient reports Soreness in injection site and slight fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,,,,,,"['Fatigue', 'Injection site pain']",UNK,MODERNA, 934230,AR,45.0,F,"Itching from shoulder to elbow within a few minutes of vaccine, took Benadryl within the hour. Swelling and itching continued to get worse. Site was hot. Stared taking Zyrtec twice a day. Within 48 hours site was so swollen visible through clothes, like a plum under the skin and was hot, itching. 99.5 temp Added Pepcid on Sunday, Swelling started going down, better Monday morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,Xanax 1-2 mg daily Levothyroxine 75 mcg daily Bystolic 10mg daily Zyrtec 10mg daily Womens Daily Gummy Vitamins daily B Complex gummy vitamins daily Align Pre and Probiotic gummy daily,,Diabetes High Blood Pressure Hypothyroid,,PCN Levaquin Morphine,"['Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Peripheral swelling', 'Pruritus']",1,PFIZER\BIONTECH, 934231,NH,34.0,F,"large rash around injection site 1/9/21 (day 10 post injection). The rash is an oval/football shape and is about 4.5 in across and 2.5 in high. There is a distinct red ring around the edge. It?s itchy, slightly warm to the touch, and there is still a lump in the center.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/09/2021,11.0,PVT,"Metformin 1500 mg daily, lexapro 10 mg daily, multivitamin daily, fish oil 1000 mg daily, vitamin D 2000 iu daily, cranberry supplement daily, biotin 50 mg daily, probiotic daily,",,"poly-cystic ovarian syndrome, anxiety/depression, obesity",,kiwi fruit,"['Injection site mass', 'Injection site reaction', 'Injection site warmth', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 934232,VA,64.0,F,Headache Neck pain Fever/Chills Nausea/Vomiting Diarrhae,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/09/2021,3.0,WRK,voltaren Divigel NExium Vit D,none,none,,robaxan,"['Chills', 'Diarrhoea', 'Headache', 'Nausea', 'Neck pain', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,SYR 934233,MA,57.0,F,"Severe body aches, very tired. Started right after I came home from grocery shopping. Slept for 4 hours then woke up in severe pain from head to toe. Got up off the couch, went to bed. Then at 3am on Sunday morning, I could take no more. Got up and took a warm bath with Epsom salt, that seemed to help the aches and pains subside. I literally did not get out of bed on Sunday 01/10/21 til noon. Today, Monday 1/11/21, I'm still pretty achy, no fever, but just really want to lay down. I did take advil during all this but it did not touch the pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,OTH,topomax & prozac,none,Asthma,,Macrodantin,"['Fatigue', 'Pain']",1,MODERNA,IM 934234,VA,35.0,F,"I got the shot around 11am on Friday, and felt fine when I went to bed. I woke up around 3am Saturday morning with a fever, chills, severe body aches and a headache. The fever went down around 6am, and I took Advil and Tylenol to help get it the rest of the way down and help with the body aches and headache. My symptoms started to resolve around noon, and I was just left feeling severely fatigued.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Synthroid Buspirone Cymbalta Warfarin Spironlactone Atorvostatin Fish Oil Vitamin B12 Vitamin D Famotidine Probiotic Magnesium,,Sneddon's Syndrome History of CVS Hashimoto's,,Sulfites (wine/cider/beer),"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SC 934235,,49.0,F,"arm sore and heavy, worst day was 1/9/21, getting better now. Trouble moving arm. Patient has taken Tylenol for the soreness. Pain is more focused on the injection site but patient has heaviness in the arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,PVT,"Tylenol as needed, no Rx",Patient sneezes a lot when wearing the mask,None,"pain at injection site with a flu shot, but symptoms dissipated within an hour",None,"['Injected limb mobility decreased', 'Injection site pain', 'Limb discomfort', 'Pain in extremity']",1,MODERNA,IM 934236,GA,65.0,F,"First began tingling on left side of forehead, then 4 hours later left temple then 6 hours later left side of lower lip and 1-2 hours later top of left cheek. [left side of jaw/ear lobe/half of cheek decreased sensation from prior surgery to remove parotid tumor since Nov. 1992] By 30 hours after vaccination I had received solu medrol and valtrex for early s/s of Bell's palsy by hospitalist at hospital. All symptoms resolved by 1/9/21 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"zocor, voltaren, jardiance, levothyroxine, zyrtec, pro-biotic, metformin, vitamin B complex, chromium picolinate, senior multivitamin, vitamin D3 , vitamin C, natural sambucus elderberry [3-way immune support]","covid-19: December 6, 2020","NIDDM, OA-bilateral knees, BMI-29.0, hypothyroidism",,"aspirin, ultram, visine opth drops,claritin","[""Bell's palsy"", 'Paraesthesia', 'Paraesthesia oral']",1,MODERNA,IM 934237,CA,58.0,F,"Eritema no hospital,no medicine ,no pain just redness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,01/08/2021,12.0,OTH,Lisinopril for Blood Pressure and Metformine for sugar levels,,,,,['Erythema'],1,MODERNA,IM 934238,NJ,30.0,F,"On day 8 post vaccine: Erythema, edema, warmth, mild tenderness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/11/2021,9.0,PVT,Zovia 1/35e mcg,None,Migraines without aura,,Minocycline,"['Erythema', 'Oedema', 'Skin warm', 'Tenderness']",1,MODERNA,IM 934239,IL,53.0,F,"States developed a dry cough and a feeling in her chest that her valve ""was sticking"". approximately 24 hours after receiving the vaccine. Patient compared it to feeling like when you have blood ""dragged out of your heart"" she feels this in her chest -- states it's aggravated by leaning on her left side. Denies it being constant. She was advised to follow up with her PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,"Multi vitamin, CBD oil, zinc, calcium, magnesium, ibuprofen, votaren gel",,,,IVP dye,"['Cardiac discomfort', 'Chest discomfort', 'Cough']",1,MODERNA,IM 934240,TX,69.0,M,sore arm for 5 days and still going,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,"farxiga, triblinta, edarbyclor, fish oil, cdb, vit d,","high blood pressure, type 2 diabetes, high cholesterol",fibromyalgia,,ACE inhibitor,['Pain in extremity'],1,MODERNA,IM 934242,NE,56.0,F,"ON 12/31/20 AT 5PM, DEVELOPED FEVER THAT WENT TO 101.8. RESOLVED 1/1/21 AT 3PM.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,SEN,,,,,,['Pyrexia'],1,PFIZER\BIONTECH,IM 934243,,32.0,F,"Patient developed generalized urticaria, nausea/vomiting 10 seconds after vaccine injection. Had difficulty swallowing after that with a feeling of airway closing. On exam, she maintained a normal, patent airway - no epinephrine was given as a result. She did receive IV Benadryl and IV Solumedrol and was transported to the hospital via ambulance. Initial vital signs were as follows: BP 130/89, HR 110, RR 16, SpO2 99%. Advised she should not get second dose of the vaccine given severity of reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,"['Dysphagia', 'Nausea', 'Throat tightness', 'Urticaria', 'Vomiting']",1,MODERNA,IM 934244,CA,57.0,F,"Dizziness, body ache, lethargic, lump at site of injection for about 5-7 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,Fish oil,,,,"Aspirin, laxatives, guafinisen (cough medication) causes swelling and rash","['Dizziness', 'Injection site mass', 'Lethargy', 'Pain']",1,PFIZER\BIONTECH,SYR 934245,CT,52.0,F,"One week after first vaccine, sudden onset - with no trauma or new medications or other known provocation developed significant pain at tendons- bilateral symmetrical - hands, wrists, elbows, neck, hips, knees, bottoms of feet",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,01/02/2021,15.0,PVT,Albuterol Fluticasone inhaler and nasal spray,,Asthma Allergic rhinitis,,Clindamycin,"['Arthralgia', 'Neck pain', 'Pain in extremity', 'Tendon pain']",1,PFIZER\BIONTECH,IM 934248,WA,25.0,F,Dizziness came on two days after receiving vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/10/2021,2.0,OTH,Nexplanon,,,,,['Dizziness'],1,MODERNA,SYR 934250,,53.0,F,"Within 10 minutes of receiving COVID Vaccine dose #2, patient experience chest pressure, increased blood pressure and exacerbation of myasthenia gravis. Patient has a history of myasthenia gravis.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,01/11/2021,0.0,PVT,,,,,,"['Blood pressure increased', 'Chest discomfort', 'Myasthenia gravis']",2,PFIZER\BIONTECH,IM 934251,IN,30.0,M,"Generalized weakness, low grade fever, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,UNK,Tolterodine,No,No,,No,"['Asthenia', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934252,WI,34.0,F,"Patient became dizzy, nauseous, weak, and had a headache within 2 hours of vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,None,,None,"['Asthenia', 'Dizziness', 'Headache', 'Nausea']",1,PFIZER\BIONTECH,IM 934253,NV,37.0,F,"Redness, swelling, itching, heat and slight pain at injection site. Baseball size.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/10/2021,11.0,WRK,"multivitamin, zytrec",none,"depression, hyperlipidemia",,sulfa = hives,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 934254,CA,30.0,F,"About 14 hours post getting the second dose I started having chills and rigor and ended up having a fever of 100.5 degrees fareinheight, took 1 gram Tylenol, fever broke, 4 hours later I had rigor and chills again and was febrile again, and took ibuprofen. I also felt nauseous and have a headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/10/2021,01/11/2021,1.0,PVT,"Synthroid, spironolactone, Claritin, deplin, pristiq, turmeric, singular, amlodipine, senna, melatonin, benedryl, co-q10, magnesium citrate",,"Migraine, pcos, seasonal allergies",,"Penicillin, sulfa antibiotics","['Chills', 'Headache', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934256,IN,36.0,F,"initial presentation of tachycardia, sweating and feeling unwell Took patient to monitoring room and her symptoms worsened after ~20 minutes. Progressed to shaking, throat getting tight (per patient) nauseous, swelling of face, flushed and said feeling cold Gave 25mg of benadryl but after symptoms progressed, gave epinephrine 0.3mg IM STAT",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,,,,,NKDA,"['Feeling cold', 'Flushing', 'Hyperhidrosis', 'Malaise', 'Nausea', 'Swelling face', 'Tachycardia', 'Throat tightness', 'Tremor']",1,MODERNA,IM 934257,AZ,41.0,F,"Swollen neck/collar bone area. Painful lump. I tried taking Tylenol for the pain and swelling but it has not gone away. I also tried ice for the swelling and warm compress for the pain. Lump is still there and painful on a scale from 1-10, its about a 7. The pain is worse at the end of the day. Been this way since the 6th of January and I thought it was sore due to the shot and the other small issues I had( headache, low grade fever) The pain was not going away after all the other issues did.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SCH,,None,None,,"Naproxen, Penicillin","['Headache', 'Neck mass', 'Neck pain', 'Pyrexia', 'Swelling']",1,MODERNA,SYR 934258,PA,51.0,F,Approximately 30 minutes after vaccination I started wheezing + coughing. My asthma is exacerbated since then.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"None. All my meds are prescribed for Hypertension, Diabetes II and autoimmune condition.",Started with asthma wheezing 30 minutes after vaccination. Day 1-4 coughing however asthma well controlled with Inhaler. I feel like I have an upper respiratory infection. Going to see my PCP.,Hypertension Diabetes Type II Ankylosing spondylitis Asthma and Seasonal Allergiers,,Seafood; Shell Fish Oral Birth control-Ortho Novum,"['Asthma', 'Condition aggravated', 'Cough', 'Wheezing']",1,MODERNA,IM 934259,TX,72.0,F,"My arm started itching yesterday but I did not look at the injection site. My arm continues to itch; today there is a pink/red area on my upper arm about 2 1/2 inches across. I am concerned that I may be allergic to the first injection and that it will be a much stronger reaction with the second injection. At this time, this is not a serious reaction. I had a flu shot 17 days previously in my opposite arm. I do not have vaccine information for this shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/10/2021,10.0,PVT,Alendronate Sodium 70 mg table - once per week; Olmesartan 20 mg tablet - once per day; Naproxen Sodium 220 mg tablet 4 -5 per week,None,high blood pressure controlled by medicine,,penicillin - mother observed rash when I was baby. My father was extremely allergic to penicillin after 2 exposures.,"['Injection site erythema', 'Pruritus']",UNK,MODERNA,IM 934260,FL,72.0,M,"Had fever, chills, achy all over. Next day at 10am he was fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/02/2021,1.0,PVT,"Lisinopril, Amlopodine, Minicycline",no,"high bp, infection for the rest of life.",,no,"['Chills', 'Pain', 'Pyrexia']",1,MODERNA, 934261,KY,42.0,F,"Bone deep body aches in back and legs, sweats like I had a fever that drenched the bed sheets, and fatigue. I slept most of the day on Sunday after getting the shot the day before. I never checked my temperature to tell if I had a fever. The night sweats continued into sunday night. I took 600mg of advil for the body aches and went to bed. When I woke up around 1:00 in the afternoon the body aches were gone and haven't returned. Sunday night I was sweating most of the night and felt over heated until around 11:00 Monday morning. I am always cold, I am the type who wears sweaters in the house all year long. For me to be that hot in the house is very unusual.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,phentermine,none,seasonal allergies,,"levaquin, percocet","['Back pain', 'Fatigue', 'Hyperhidrosis', 'Night sweats', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934262,CA,38.0,F,Swollen left under eye noted at 0500 the morning after the vaccine where fillers are in. Prednisone and zyrtec started and swelling has improved however 1 more day left of medications.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,none,none,none,,"PCN, ibuprofen",['Eye swelling'],2,PFIZER\BIONTECH,IM 934263,NM,92.0,M,"The resident resides in an independent living facility/apartment. The reporter at the center was informed by his daughter he was not feeling well on 1/1/2021 (specific symptoms could not be ascertained). He reportedly went to be COVID tested on 1/1/2020 and observed to be deceased in his apartment on 1/2/2020. I do not have confirmation of his COVID results, although the reporter indicates his daughter reports his test was positive.",Yes,01/02/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,SEN,,,,,,"['Death', 'Malaise', 'SARS-CoV-2 test positive']",1,MODERNA,UN 934264,TX,53.0,F,"Low grade fever, HA, fatigue, pain and swelling at the injection site. Tylenol and Motrin with improvement.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/10/2021,1.0,PVT,,,,,,"['Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934265,AL,37.0,F,"Starting within the hour of my shot my left arm was very stiff and throbbing in pain. By 5pm I could not wiggle my fingers or even the slightest movement in my arm. At 7pm I started with a headache, complete body shakes, and a fever of 100. In the night it spiked to 102.6 All day Friday my fever stayed at 101-102.8. I had a bad headache and could not get any relief in my arm. My body ached and still had shakes from time to time. I took ibuprofen a couple of times to help with the pain and fever. By Saturday around 10am I had zero symptoms. Since then I have felt great.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,none,none,none,,none,"['Headache', 'Injected limb mobility decreased', 'Musculoskeletal stiffness', 'Pain', 'Pain in extremity', 'Pyrexia', 'Tremor']",1,MODERNA,SYR 934266,IN,58.0,F,"Second COVID immunization from Pfizer at 0930 sat. (No symptoms at all with first immunization) Symptoms of fatigue began approx. 12 hrs. late, then fever after midnight, chills, body aches, severe headache, abd cramping, and extreme fatigue. Highest fever recorded was 101.8 the next day (Sunday) around 4pm. Didn't take Tylenol or Motrin. As of writing this (Monday 12:07 pm) my fever is gone but headache and extreme fatigue remain. Injection site still sore and today I notice I have a very swollen and painful lymph node left axilla opposite injection site. I had to call in sick today and possible will tomorrow if the extreme fatigue and headache don't go away.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,WRK,None,None,"RA, hypothyroidism, PSVT",,Zithromax,"['Abdominal pain', 'Chills', 'Fatigue', 'Headache', 'Impaired work ability', 'Injection site pain', 'Lymph node pain', 'Lymphadenopathy', 'No reaction on previous exposure to drug', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934267,,23.0,F,"The night of the vaccine I became very fatigued, had moderate muscle aches, and a mild headache. In the middle of the night I woke up with severe chills, severe muscle aches, and mild headache. The next morning I had a temperature of 99.3 which climbed throughout the day to a temperature peaking at 100.9 in the evening. I had moderate chills, severe muscle aches, severe body aches, mild headache, and moderate injection site soreness. I also felt generally ill. I took Tylenol and ibuprofen alternating starting the evening of the vaccine. Day 2 after the vaccine my temperature is 98.6, I have mild body aches and mild headache. No other symptoms remain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,UNK,None,None,Asthma,,"Peanuts, propylene glycol, and seasonal allergies","['Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Pain']",2,PFIZER\BIONTECH,IM 934269,GA,48.0,F,"Moderna Vaccine; 7 days after vaccination my arm became itchy, red, and swollen. It is round and redness is around the size of a softball. Also developed rash/like hives on upper legs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PUB,Allegra and Benadryl,eczema,seasonal allergies and eczema,,seasonal allergies. break out after eating strawberries age 9.,"['Erythema', 'Peripheral swelling', 'Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 934270,,36.0,M,"Fever 103.1F (39.5C), chills, body aches, fatigue, nausea, loss of appetite, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/09/2021,0.0,PVT,allegra and Claritin,none,none,,seasonal allergies - cedar,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934271,OH,34.0,F,"At 10:45 while sitting in Observation Room, Caregiver developed itching in extremities. At 11:00 am she developed redness in face and chest and swelling in her throat. Caregiver had her own Epi Pen and injected it into her thigh. RN was at her side the entire side. This RN arrived just after injection. Caregiver sitting upright, alert and oriented x3. No respiratory distress noted. She complained of tingling in the lips and swelling in the throat. At 11:06 she states the lip tingling was less. Vital signs were BP: 120/66, HR:71, RR: 14, Sao2: 100% Room Air. At 11:08 the throat swelling was less restrictive per caregiver and no tingling felt in lips but having itching of feet and hands.. At 11:11, water given. At 11:12, caregiver states tightness is less rating it 4/10 on a scale for tightness. AT 11:25 BP: 130/76, HR: 69, RR:16, Sao2: 100% room Air. At 11:36, caregiver states the tingling was much less rated 2/10 but itching still felt in hands, feet and chest. Caregiver to be evaluated by ER doctors since she injected her Epi pen and is still having symptoms. 11:52 Caregiver with unchanged symptoms but also c/o headache. Taken via wheelchair by RN to Emergency Room.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,01/11/2021,0.0,PVT,None,none,PTSD,,"PCN, coconut and adhesives","['Erythema', 'Headache', 'Paraesthesia oral', 'Pharyngeal swelling', 'Pruritus', 'Throat tightness']",UNK,MODERNA,IM 934272,OK,69.0,M,"chills, headache, nausea, joint pain, breathing problems, lethargic,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/06/2021,2.0,PUB,"lipitor, flomax ,dexilant, cymbalta, singular (supplements-coq 10,calcium citrate, fish oil",none,"asthma, sleep apnea",,none,"['Arthralgia', 'Chills', 'Dyspnoea', 'Headache', 'Lethargy', 'Nausea']",1,MODERNA,IM 934273,IN,57.0,F,Moderate nausea shortly after vaccination with a 2 hour duration. Severe joint pain and burning beginning 28 hours after vaccination with a duration of 12 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,OTH,Welbutrin Simvastatin Nuvigil Raloxifine ASA 81mg Vitamin B12,Positive COVID 19 result 12/10/2020.,High cholesterol Obesity Situational depression Work related sleep disorder,,None,"['Arthralgia', 'Nausea']",1,MODERNA,IM 934275,AL,38.0,F,redness and rash at injections site as well as inner right thigh,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/08/2021,10.0,PVT,Vitamin c d and zinc,,,Inflfuenza,latex penicillin and ibuprofen,"['Injection site erythema', 'Injection site rash', 'Rash']",1,MODERNA,IM 934276,SD,64.0,F,"7 days after receiving the 1st moderna shot I woke up with an itchy upper right arm in the area I received the shot, It felt warm to the touch and was angry red in color. I drew an ink line around the border, and by the end of the day, it was about an inch out of the original border. Started out about 3 0r 4 inches wide and about the same long. I treated it with cortisone cream, baking soda poultice, calamine lotion. I took ibuprophen and took two Benadryl at night before going to bed. The next morning the redness was less noticeable, still itchy, but by the next day it was about gone. So about 48 hours. A co worker also had this happen to her 7 days later",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/03/2021,8.0,PVT,"lisinopril, latanoprost, vitamin 3, multi vitamin, biotin",no,"pre-hypertension, glaucoma",,no,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",UNK,MODERNA,IM 934277,CA,30.0,F,"Syncopal event: At 15 minutes post dose patient reported feeling faint in her chair in our waiting area. She was very pale and sweaty, c/o palpitations. Moved to a chair legs that elevate, given some water, refused food, (says she ate lunch prior to coming for vaccine) , We monitored her for about 1/2 hour and then she felt fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Unknown,None stated,None stated,,None stated,"['Blood pressure systolic decreased', 'Dizziness', 'Hyperhidrosis', 'Pallor', 'Palpitations', 'Syncope']",1,MODERNA,IM 934278,,42.0,F,"Arm swelling, Red spot at site of vaccine. Diarrhea, Pain Scalp pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,UNK,,,,,,"['Diarrhoea', 'Injection site erythema', 'Pain of skin', 'Peripheral swelling']",1,PFIZER\BIONTECH, 934279,NJ,62.0,F,"Received Moderna covied vaccine @ 8:05 am then 20 minutes after the injection i developed Palpitations HR=130,redness on neck, chest & forehead area, Petechiae rashes on both arms.BP 200/109.was sent to ER for further evaluation.EKG was done,NS 500c given IV ,blood drawn & sent to laboratory for CBC & BMP. released from ER @ 12.30 when my BP & HR was normal.redness on my neck & chest was less but Petechiae rashes subsided in the evening of same day.Early morning Friday Jan.8,2021 temp was 100.2.felt bodyaches & headache. when i checked my temp i noticed a lymph node in my left armpit.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Janumet ,Amaryl,Prandin,Losartan,Clonidine,Crestor VitaminC,Vitamin D,Zinc,Magnesium",,"Diabertes,Hypertension,High Cholesterol",,"Penicillin,Sulfa,alcoholic drinks","['Blood pressure abnormal', 'Body temperature increased', 'Electrocardiogram', 'Erythema', 'Full blood count', 'Headache', 'Heart rate abnormal', 'Lymphadenopathy', 'Metabolic function test', 'Pain', 'Palpitations', 'Petechiae', 'Rash']",1,MODERNA,IM 934280,IL,38.0,F,"Tuesday 1/5/21 AM tender arm and small raised bump at injection site. Tuesday 1/5/21 PM felt flushed but no fever and still raised bump with a welt at injection site and tender. Took Benadryl. Wednesday 1/6/21 AM felt flushed but no fever and still raised bump got larger with a welt at injection site still tender. Wednesday 1/6/21 PM felt flushed but no fever and still raised bump got larger with a welt at injection site and my legs felt like they had ants on them. Took Benadryl Thursday 1/7/21 Welt went down and started to feel better however still redness and tender. Friday 1/8/21 Just bruised at site of injection and arms welt is down a lot more. Sat 1/9/21 PM Felt fatigued by evening time Sunday 1/10/21 Headache, joint pain and extreme fatigue. Had rash on both arms appear and still felt flush with no fever. Slepts 15 hours Monday 1/11/21 Headache, joint pain and extreme fatigue. Had rash on both arms/face/neck appear and still felt flush with no fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,no,,"Hidradenitis, joint pain, heart palpitations (PVC) and psoriasis",,"Adhesives, Barium Iodide, Cephalexin, Latex, Morphine, Sulfa Antibiotics, Tree nuts (pine nuts)","['Arthralgia', 'Erythema', 'Fatigue', 'Feeling abnormal', 'Flushing', 'Headache', 'Injection site bruising', 'Injection site rash', 'Rash', 'Tenderness', 'Urticaria']",1,MODERNA,SYR 934282,CA,78.0,M,"I got lightheaded on the drive home. Since I got home I had cramps, gas and diarrhea. I've recovered some but not 100%. Ate no dinner last night. Its been 5 days with these symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Furosamide 40 mg. Entresto 24 mg. Eliquis 5mg. Polvix 75 mg. Linagliptin 5mg. Jardiance 25 mg. Tramadol 50mg as needed. Metopolol 25mg. Omega3 3000mg. Vitamin E 100IU, Vitamin B complex, Vitamin D 1000 units, Multivitamin, Levemir inject",no,"Diabetic, Heart condition, kidney problem and COPD.",,Penicillin & Bell peppers,"['Diarrhoea', 'Dizziness', 'Flatulence', 'Muscle spasms']",1,MODERNA,SYR 934283,CT,95.0,F,"1/8/21 Area of blue/purple discoloration measuring 5cmx4.5cm, to where injection of the Pfizer Covid-19 vaccine was given on 1/7/21. Resident moves arm when area touched. Scant amount of dried blood noted to area where resident appears to have been scratching. Resident afebrile without rash to area. Minor swelling noted at site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,SEN,"Amlodipine, Aspirin, Atorvastatin, Vit.D3, Metoprolol Tartrate, Multivitamin, Prednisone, Prilosec, Risperidone, Trazodone, Tramadol, Therapeutic Mineral Ice Topical to back, Artificial Tears",+Covid-19,"HTN, Heart failure, Unspecified fracture of shaft of left ulna,Unspecified dementia,Polymyalgia rheumatica",,Cymbalta,"['Injection site discolouration', 'Injection site pain', 'Injection site swelling']",1,PFIZER\BIONTECH,IM 934284,MN,36.0,F,"Patient reported, ""I received my Covid 19 vaccination on Monday evening. I experienced a reaction immediately following. Within 10 minutes I had tachycardia (130s), high BP (160s), lightheadedness, nausea, headache, and feeling like I was going to faint. I was attended to by Ambulance paramedics. At the time of her report to her primary care provider on 1/7/2021, she was still having pretty significant side effects (headache, dizziness, and light sensitivity), enough so that I was staying home from work. These symptoms have now resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"hydroCHLOROthiazide (HYDRODIURIL) 25 mg tablet 5/12/2020 Sig: TAKE 1 TABLET BY MOUTH DAILY ibuprofen (ADVIL,MOTRIN) 200 mg tablet 12/22/2016 Sig: Take 3 tablets by mouth every 6 (six) hours as needed. Pain. �Alternate with acetaminophe",,"Metatarsalgia right, Hypertrophy of the uterus, hypertension essential primary, menorrhagia, left salpingo oophorectomy December 2016 due to a Left ovarian mucinous cystadenoma, acne, Gluteal Tendinitis Right Hip, Wart Plantar, Anxiety, Depression Major One Episode Mild , Insomnia, Nevi Multiple",DTP at 3 years old (no record) with seizure and no sequelae,"Diphtheria, Pertussis, Tetanus Vaccine (seizure)","['Blood pressure increased', 'Dizziness', 'Headache', 'Impaired work ability', 'Nausea', 'Photophobia', 'Tachycardia']",1,PFIZER\BIONTECH,IM 934285,AZ,53.0,F,"POST VACCINATION SHOT- APPROX. 17 MINUTES- C/O FRONTAL AND TEMPORAL HEADACHE (4:10 PAIN SCALE LEVEL). DOES NOT USUALLY GET A HEADACHE. DENIES ANY OTHER COMPLAINTS AT THIS TIME. EMS AND RN ON SCENE, ASSESSMENT MADE . 0957: VS: BP: 111/76; P: 79; 02 SAT: 97 % ON ROOM AIR; 1003: VS: BP: 110/78; P: 77; 02 SAT: 96% ON ROOM AIR.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,,,,,,['Headache'],1,PFIZER\BIONTECH,IM 934286,MI,29.0,M,"0700- Vaccine 0800 -2200- Clear urine, 1-2 times per hour, 300-500ml each time 2200-2300 sleep 2300 - woke up, felt jittery, provided car for emergent surgical case 0100 - felt like headed, drank 50oz water, felt better after 20 minutes 0400 - 0700 - sleep. Woke up 3 -5 times and urinated 300-500 each time clear urine 0800- 0900 - drove home 0900-1000- Urinated 3 times while attempting to fall asleep, each time 500ml if clear urine. Massive 10/10 right sided headache 1000-1300 sleep 1300- present- woke up. Felt ok, able to eat and drink, felt ?normal? by the following morning",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None,None,,None,"['Dizziness', 'Feeling jittery', 'Headache']",1,PFIZER\BIONTECH,IM 934287,UT,26.0,F,"Swelling, pain, redness, itching at the site and fever",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/10/2021,2.0,WRK,,Covid-19,,,"Tylenol, Erythromycin, amoxicillin","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Pyrexia']",1,MODERNA,IM 934288,NC,44.0,F,"24 hour post vaccine: soreness. Day 8 post vaccine: hives, welts at injection site. Day 13: cellulitis, swelling, tightness, heat, numbness at the center, and itchiness. The edges are raised creating a wall where the redness ends. Covers most of my upper arm, from shoulder to elbow and starting to work into the inner arm, armpit, and left breast. Just received a dose of Kenalog this morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,,,,,,"['Erythema', 'Injection site cellulitis', 'Injection site erythema', 'Injection site hypoaesthesia', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Injection site urticaria', 'Injection site warmth', 'Pain', 'Skin tightness', 'Urticaria']",1,MODERNA,IM 934289,WV,63.0,F,"JAN2-HEADACHE, JAN 3 RIGHT SIDE OF TONGUE BECAME NUMB, AND JAN 4 RIGHT SIDE OF MOUTH BECAME NUMB, RIGHT EYE PAIN WITH TEARING, NOTICABLE DROOPING RIGHT SIDE OF FACE, MINIMAL ACTIVE MOVEMENT, FLUIDS DRIBBLED OUT OF RIGHT SIDE OF MOUTH WHEN DRINKING LIQUIDS, EVALUATED BY PA ON 1/5, DIAGNOSED WITH BELL'S PALSY, STARTED ON VALACYCLOCIR 1 GM THREE TIMES A DAY AND PREDNISONE TAPER BEGINNING WITH 60 MG X 5 DAYS AND TAPERING DOWNWARD",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/02/2021,10.0,PVT,"HCTZ, AMITRIPTYLINE, ELIQUIS, CYMBALTA, ESTRAGEN PATCH, PROAIR AS NEEDED, CINNAMON, NIAGEN, FIBER, MAGNESIUM, PROBIOTICS, QUNOL, SUNFLOWER LECITHIN, VITAMIN D3, ZINC",NONE,"HTN, HASHIMOTOS THYROIDITIS, HYDRENITIS SUPPORATIVA, ARTHRITIS",,"DEMEROL, PERCOCET, WELLBUTRIN, CELEBREX, GABAPENTIN, NSAIDS","[""Bell's palsy"", 'Eye pain', 'Facial paralysis', 'Full blood count normal', 'Headache', 'Hypoaesthesia oral']",1,MODERNA,IM 934290,WA,28.0,F,"10:33p started with flushed feeling, dizziness and nausea ,no sob,150/90,83,96 given H2O 10:45p symptoms improving still flushed and hot, more H2O 158/108, 79, 98%, 10:50p feeling better,not flushed or hot feeling,149/96 78,98% stayed 40m, called 01/08 vm patient called back feeling better just sore arm and minor swelling at injection site. told to call PCP or 911 if symptoms return and are worse.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,"metformin, zoloft, anti-inflammatory",none,"DM, PCOs, Liver issues",,none,"['Dizziness', 'Feeling hot', 'Flushing', 'Injection site swelling', 'Nausea', 'Pain in extremity']",1,MODERNA,IM 934291,KS,33.0,F,"reports large painful axillary lymphadenopathy in L arm, has been applying heat to site with no relief, advised to f/u with PCP regarding symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Injection site lymphadenopathy', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 934292,CO,52.0,M,Very mild but noticeable numbness in tongue towards back of tongue (not front) on either side. Seemed to dissipate after six hours. Was not immediately noticeable and seemed to be more pronounced about 1/2 hour after injection. I had the other expected soreness at injection site and general malaise approximately 24 hours after - 96 hours after vaccine and I am only reporting this as I was not expecting the numbness in the tongue and was not sure if it was an adverse effect or just stress related.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Advair, ibuprofen",None,"Asthmatic, Obesity",,None known,"['Hypoaesthesia oral', 'Injection site pain', 'Malaise']",1,MODERNA,IM 934293,CO,36.0,F,"developed shingles, saw PCP on day 5 to diagnose, start antivirals. Symptoms (rash, pain) started on day 1.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,"fluoxetine, cetirizine, multi-vitamins",none,depression,,none,['Herpes zoster'],1,MODERNA,IM 934294,IN,36.0,F,"Reported tachycardia + sweating and asked for help initial presentation was not severe and gave her 25mg of bendaryl after around 20 minutes, patient started to shiver, feel cold/unwell, said throat was getting tight, she was nauseous. Epinephrine 0.3mg IM was given STAT and EMS called. Patient was taken to the emergency room onsite and is being seen now. Upon arrival to the ED, reported SOB, swelling of the face/tongue and was still shaking",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,none,none,none,,NKDA reported sensitivity to chapstick,"['Chills', 'Feeling cold', 'Hyperhidrosis', 'Malaise', 'Nausea', 'Swelling face', 'Swollen tongue', 'Tachycardia', 'Throat tightness', 'Tremor']",1,MODERNA,IM 934295,FL,50.0,F,"Facial redness, itching and dryness Eye area swollen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/09/2021,3.0,UNK,Amlodipine besylate Vitamin D3 Vitamin C Zinc Vitamin B12 ProActive,None,None,,None,"['Dry skin', 'Erythema', 'Eye swelling', 'Pruritus']",1,MODERNA,SYR 934296,CO,25.0,F,"Swelling, heat, knot, bruising",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/05/2021,6.0,PUB,None,Sore throat a few weeks before-- negative covid test,None,,None,"['Contusion', 'Nodule', 'Skin warm', 'Swelling']",1,MODERNA,SYR 934297,NY,52.0,F,"NOT TECHNICALLY CLASSIFIED AS ADVERSE EVENT , and may be considered "" common side effects"" but had a severe reaction to the vaccine with fever, chills, muscle and joint aches, headache, nausea, fatigue, soreness in arm at site of injection starting approx 14 hours after injection and lasting 48 hours, with lesser effects lasting another 24 hours, and am still not feeling fully recovered as of 1/11/21 12:11pm. Temperature highs ranged from 100.8-101.4, and I felt as badly as when I had COVID-19 in March 2020. I was unable to go to work as scheduled on Friday 1/8 and Saturday 1/9. I am concerned about getting the 2ND DOSE as it has been stated that 2nd dose may create more severe symptoms than the first. PLEASE ADVISE. Also, is there a correlation between having had COVID-19 and having strong ""side effects"" to the vaccine? Please advise. Thank you!",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PUB,"Vit D3 3,000units/day - not every day Emergen-C (pharmacy generic version)",None,pre-diabetes mild hyperlipidemia,,Penicillin,"['Arthralgia', 'Fatigue', 'Feeling abnormal', 'Headache', 'Impaired work ability', 'Injection site pain', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,IM 934298,NY,49.0,F,"Approximately 15 minutes after the vaccine administration, the patient reported numbness in mouth / jaw and difficulty swallowing. These symptoms are similar to the symptoms she had in the past after exposure to shellfish. The patient received 1 dose of epinephrine and 1 dose of diphenhydramine with improvement in symptoms. The patient subsequently went home, had recurrent symptoms, and went to a local emergency department for additional treatment. In the emergency department, she received steroids and anithistamines and symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,"Ibuprofen, Cetirizine",None,,,"Shellfish-derived products, Iodine","['Dysphagia', 'Hypoaesthesia', 'Hypoaesthesia oral']",1,MODERNA,IM 934299,GA,24.0,F,"redness, swelling of the left axilla area.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,PUB,none,none,none,,none,"['Erythema', 'Swelling']",1,MODERNA,IM 934300,NY,52.0,F,Muscle ache and tinnitus. Denies hearing loss,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Myalgia', 'Tinnitus']",1,PFIZER\BIONTECH,IM 934301,FL,51.0,F,"Nausea, dizziness, soreness of the entire arm that the vaccine was administered in, swelling under the arm that was vaccinated, and weak.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Atorvastatin, Lantus U100, Losartan, Trulicity, Vitamin D3, cyclobenzaprine(PRN)",,"Type II Diabetes, hyperlipidemia, obstructive sleep apnea syndrome, vitamin D deficiency, dyspnea, essential hypertension, first degree atrioventricular block, hx of pneumonia, obesity",,Penicillin,"['Asthenia', 'Dizziness', 'Injection site swelling', 'Nausea', 'Pain in extremity']",1,MODERNA,IM 934302,CA,41.0,F,"41 Y female who presents to the Emergency Department for evaluation of her rash. The onset of rash was gradual beginning 2 days ago with progression since that time. The rash began on the abdomen 2 days ago and 1 day after her second immunization with Pfizer COVID-19 vaccine. The rash over the next 24 to 48 hours spread to the back, the chest, the arms, and inguinal folds, and popliteal areas. This morning she woke up with itching and hives on her scalp. She has used Benadryl with some relief. Patient denies shortness of breath, chest pain, nausea, or vomiting. � There is no lip swelling or itching, tongue swelling or itching, sense of throat closing, or shortness of breath. There is been no nausea vomiting, no palpitations. � She has no hx of similar previous allergic reactions. She denies exposure to new medications, shampoos, detergents, soaps, lotions, sprays or allergens.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,None,None,None,,None,"['Pruritus', 'Rash', 'Urticaria']",2,PFIZER\BIONTECH,IM 934303,CA,65.0,M,The day of the vaccine at 10PM. I developed severe chills temperature of 101 headache and body aches lasted 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,NONE,NONE,,NONE,"['Body temperature increased', 'Chills', 'Headache', 'Pain']",1,MODERNA,SYR 934305,OH,40.0,F,Tiredness Gastrointestinal effects,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/21/2020,0.0,SEN,,,,,,"['Abdominal discomfort', 'Fatigue']",1,PFIZER\BIONTECH,IM 934306,MI,45.0,F,Vasovagel syncope episode - passed out a total of 3 times Drop in pulse ox and heart rate,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,Tizanidine 4mg at night Albuterol 90 mcg inhaler 2 puffs as needed Symbicort 160-4.5 mcg 1 puff twice a day Buspirone 15 mg twice a day Montelukast 10 mg once a day Lamotrigine 150mg once a day Trazadone 200mg at night Hydroxyzine Pamoate 2,,Asthma Biopolar GERD Vasovagel syncope Hyperlipidemia,,Penicillin Wellbutrin,"['Condition aggravated', 'Heart rate decreased', 'Syncope']",2,PFIZER\BIONTECH,SYR 934307,MD,55.0,F,"began w/ change in level of mental status by 5:30 pm the day of vax, and then progressed to high fever of 104, heaviness in legs,unable to walk/stand, cognition foggy, unbalanced. Left sided arm/leg mobilitylimited. Jaw, head, ear and neck pain radiating up to left arm into head. Next day after vaxx (Thurs 1/7/2021) woke up thinking it would have resolved and was worse, shaking chills, fever still elevated, face swollen and hot, difficult to stand up straight, heavy limbs and unable to walk normally. This lasted all day, very fatigued almost a change is mental alertness as well. Tried to stay hydrated, took tylenol and motrin alternatively all day, loss of taste and smell, could not focus to read anything all day and into evening of 1/7/2021. At about 830 pm on 1/7/2021, began to feel slight improvement in balance and cognition. Went to bed early and woke up about 2 or 3 am on 1/8/2021 drenched from fever breaking I suspect. Rash on face after fever broke. Continued with tylenol and motrin and hydration, gradual improvement into early morning of 1/8/2021 and by the afternoon, I was very much improved. However, lingering parastethesias in left jaw, neck, ear and into left arm and fingers, even today 1/11/2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,"Prozac, 10 mg Synthroid, 150 mcg Vit C 2000 mg/day Vit D B12 supplement","The month prior I was out with COVID like symptoms, and had close contact with a positive (boyfriend) with symptoms. My symptoms started 12/12 and lasted until 12/24, resolved for a couple of days, then began again on 12/27, resolving rather quickly by 12/30/2020.","asthma (season, began in 2019, easily controlled). CAD (3 cardiac stents placed in 2017).",,gluten intolerant (since 2012) Allergic to latex (contact dermatitis),"['Ageusia', 'Anosmia', 'Balance disorder', 'Chills', 'Disturbance in attention', 'Dysstasia', 'Ear pain', 'Fatigue', 'Feeling abnormal', 'Gait disturbance', 'Gait inability', 'Headache', 'Hyperhidrosis', 'Limb discomfort', 'Mental status changes', 'Mobility decreased', 'Neck pain', 'Pain', 'Pain in jaw', 'Pyrexia', 'Rash', 'Skin warm', 'Swelling face', 'Tremor']",1,MODERNA,IM 934308,TX,60.0,F,"First dose, had no reaction. Second dose, severe pain in arm, headache, back ache (lower, in proximity of kidneys), extreme tiredness, temperature over 99 degrees. This began approximately 18 hours after second dose. When the symptoms were at their worse, I went to bed and slept for over 4 hours. I felt better after I woke, however, the symptoms did not completely subside for an additional 6 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Lamictal Synthroid Claritin Magnesium,None,Hypothyroidism Epilepsy,,None,"['Back pain', 'Body temperature increased', 'Fatigue', 'Headache', 'Pain in extremity']",2,MODERNA,IM 934309,IN,38.0,F,"Left arm very swollen, hot to the touch, pain in whole arm, injection site hard as a rock, injection site very red, red circle around injection site. Went to ER, blood work and ultrasound done. Prescribed steroids and Claritin",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,"Emgality, multivitamin and vitamin C",,Chronic migraines,,Penicillin and sulfa drugs,"['Blood test', 'Injection site erythema', 'Injection site induration', 'Pain in extremity', 'Peripheral swelling', 'Skin warm', 'Ultrasound scan']",UNK,MODERNA,SYR 934310,OK,50.0,M,Developed a rash the next day on most of my body.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,PVT,"Dexilant DR 60MG, Benicar HCT 20-12.5 MG,Loratadine 10 mg, D3 500mcg",Seasonal Allergies.,Blood Pressure and seasonal allergies,,Gluten. Dairy suspected but not confirmed. No Allergies to any medications that I know of.,['Rash'],1,MODERNA,SYR 934311,NY,78.0,F,"On 1/8/2021 patient called stating her right knee was swollen and painful, an 8/10 on pain scale, she iced it and took Tylenol now 5/10 pain scale. Patient received 1st dose of Moderna on 1/7/2021.Patient stated that she thought she remembered joint pain was a side effect of vaccine. Provider spoke with patient and stated more than likely knee pain due to far driving distance and walking more than usual. Continue topical and OTC treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,"OS-Cal, levothyroxine, atorvastin",,Chronic Kidney disease stage 2; Hyperlipidemia; hypertension; Rheumatic mitral stenosis; long tern antiquag use,,Iodine contrast,"['Arthralgia', 'Joint swelling']",1,MODERNA,IM 934312,PR,52.0,F,"WHEN ADMINISTRATING THE SECOND DOSE OF THE COVID VACCINE, IT APPEARED THAT THE NEEDLE WAS LOOSE AND SOME OF THE DOSE WAS LOST. THE PATIENT SAW THE LIQUID OUT IN HER ARM. THE PATIENT THIT NOT RECIEVED THE 0.3 ML DOSE. WE CONTACTED THE PFIZER TEAM FOR INSTRUCTIONS AND RECIVED LITERATURE. PATIENT DECIDE THE RE DOSE 0.3 ML ON 01/07/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,NONE,NONE,ASTHMA,,NONE,['Incorrect dose administered'],2,PFIZER\BIONTECH,IM 934313,FL,28.0,F,"Itching, redness, swelling, pain at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/11/2021,7.0,PVT,"Buspar, synthroid",N/a,Hypothyroidism,,N/a,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 934314,NH,36.0,F,Cellulitis treated with oral antibiotics,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/08/2021,8.0,UNK,Mirena IUD,,"OSA, obesity",,NKA,['Cellulitis'],1,MODERNA,IM 934315,,23.0,F,"Headache, nausea, body aches, tightness of chest, shallow breaths/shortness of breath, light headed, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Duplixent,,,,,"['Chest discomfort', 'Dizziness', 'Dyspnoea', 'Electrocardiogram normal', 'Fatigue', 'Headache', 'Hypopnoea', 'Nausea', 'Pain', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,SYR 934316,WV,19.0,M,I had pain at the injection site and headaches for three days then since then from the seventh I had had red dots appear around my neck and left shoulder,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/07/2021,3.0,PVT,"Guanfacine, Methylphenidate, and Escitalopram",Had the flu around thanksgiving,,,,"['Headache', 'Injection site pain', 'Rash']",1,PFIZER\BIONTECH,SYR 934317,TX,59.0,F,"Pain began about 6hours after I received the shot, and lasted about 24 hours. Today when showering I noticed that there's an area 4? wide that is still bright red and bruised. It looks pretty bad.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,Cell Cept 500 mg Lisinopril 5 mg Crestor 5 mg (2 x/week) Levothyroxine 50 mcg Calcium citrate 600 mg Vit D 50 mcg Vit C 500 mg Multivitamin Niacin 500 mg (2x/week),,Lupus nephritis,Pain after flu shots. Lasts about 4 days.,"Codeine, sulfa, erythromycin, medrol, chloroprep,","['Contusion', 'Erythema', 'Pain']",1,MODERNA,IM 934318,LA,77.0,M,"Chills, low grade fever, generalized muscle aches, headache . Lasted approximately 36 hours. Treated with Tylenol and Inuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/07/2021,2.0,PVT,"Flecanide, toprol xl, Crestor, enapril, bit D, Magnesium, Calcium,",No,"Cardiovascular disease, hypertension,",,"Sulfa, Crlebrex","['Chills', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934319,IN,53.0,F,"Aches, chills, generalized soreness, inj. site pain, localized redness and swelling. Cough, minimal yellow phlegm, hoarseness. Most sx were better after 24 hrs. The non-productive cough decreased over the next 3 days . * I did not check my temp when chilled- the chills lasted about 2 hours only.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,UNK,"Lexapro, Wellbutrin, multivitamin, probiotic",Covid positive 12/6/2020,"Breast cancer in remission for 20 yrs, lymphedema, OSA.",,"Morphine, hydrocodone","['Chills', 'Cough', 'Dysphonia', 'Erythema', 'Injection site pain', 'Pain', 'Swelling']",1,MODERNA,IM 934320,TX,45.0,M,"All symptoms occurred at the 12-24hr mark: metallic taste, chest tightness, limb (needle like) itching, cold sweats, body ache/pain, chills, nausea. All symptoms resided except for malaise after the 24hr mark. Malaise current through today(11JAN21)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,MIL,none,none,none,,Codeine/Percocet- rash,"['Chest discomfort', 'Chills', 'Cold sweat', 'Dysgeusia', 'Malaise', 'Nausea', 'Pain', 'Pruritus']",1,MODERNA,IM 934321,WA,57.0,M,"C/O DIZZINESS AND LIGHTHEADNESS AT 1020 PM . B/P 140/90,P74, O2 97% MONITORED & GIVEN 5 CUPS OF H2O.1030PM 142/74, 80, 96% STILL DIZZY AND GIVEN MORE H2O, 1055PM 130/76,64,100% STATES FEELING BETTER NO SYMTOMS, CALLED NEXT DAY 9/8 FEELING BETTER HYRD/EAT instructed to call provider or 911 if symptoms worsen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,none,none,unknown,,none,['Dizziness'],1,MODERNA,IM 934322,OH,46.0,F,Enlarged (L)Supraclavicular Lymph node. Myalgias,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,"Align probiotic, HCTZ, Amlodipine, Effexor XR.",None.,"GERD, Anxiety",,None,"['Lymphadenopathy', 'Myalgia']",1,MODERNA,IM 934323,,31.0,F,Itchy rash on both left and right upper arms. Symptoms subsided after taking Benadryl 25mg,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/09/2021,3.0,SEN,,,,,,"['Injection site reaction', 'Rash', 'Rash pruritic']",1,MODERNA,IM 934324,NJ,35.0,F,Red rash on right arm around the site where vaccine was administered,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/09/2021,9.0,PVT,Vegan prenatal vitamin and vegan calcium and vitamin d supplement,Nonr,None,,Zithromax,"['Injection site rash', 'Rash erythematous']",1,MODERNA,IM 934325,NY,32.0,F,Chills Headache Joint pains Muscle pains Fever >102,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,None,None,None,,None,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 934326,CO,55.0,F,Patient states ''I received a COVID vaccine yesterday''. Shot was given yesterday at 2:30 pm. Patient states allergic reaction started 10-15 minutes after shot was given. Patient states her eyes are itching and red. Patient states redness around her eyes and legs. RN triaged patient and recommended patient to go to ED now. Patient states she is going to wait and see if she feels better. Denies difficulty breathing or difficulty to swallow.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,Unknown,Unknown,,,Unknown,"['Erythema', 'Eye pruritus', 'Ocular hyperaemia']",1,MODERNA,IM 934327,TN,40.0,F,I had large red and hot welt. I had lip node enlargement. It lasted for a week.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/23/2020,2.0,WRK,None,None,None,,Levaquin,"['Erythema', 'Lymphadenopathy', 'Urticaria']",1,PFIZER\BIONTECH,IM 934328,MA,58.0,F,"Extremely sore arm at the injection site, ice applied, minimal relief. Took ibuprofen x 2 days. The 3rd day, my arm was fine, but I experienced extreme fatigue, no energy, and actually had to take a nap!! By day 4, I was fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,"Vit. C, cherry extract, calcium with vit. D, COQ-10, selenium, baby asa.",N/A.,"Hypoglycemia, hormone imbalance, hyshimatta's,, infertility, mild arthritis.",,Allergic to prednisone.,"['Asthenia', 'Fatigue', 'Injection site pain']",1,MODERNA,IM 934329,MA,59.0,F,"about 7 days later, acute onset pruritis at the injection site, looked like a mosquito bite. then resolved 2 hrs later",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/07/2021,8.0,PVT,vit D omega oil sertraline,,,,amox,['Injection site pruritus'],1,MODERNA,IM 934331,,47.0,F,"Fever 103, myalgias, HA, insomnia, SOB, hallucinations, rigors. Symptoms lasted longer than 24 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,"Seroquel 25 mg, Clonazepam 1 mg, Omeprazole 20 mg, Bentyl 10 mg, Imitrex 25 mg, levothyroxine 50 mcg. Vitamin D, Calcium, Turmeric, multi-vitamin, CBD oil, B-complex.",none known,"Acne, sesaonal allergies, migraines, eczema, insomnia, myopia, anxiety, GERD, depression,",,Valtrex. Trazodone.,"['Chills', 'Condition aggravated', 'Dyspnoea', 'Hallucination', 'Headache', 'Insomnia', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 934332,WI,60.0,F,Have very bad body aches and hot and cold sweats . I have been taking ibuprofen 2 times and symptoms get better.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,None,None,None,,None,"['Feeling hot', 'Hyperhidrosis', 'Pain']",2,PFIZER\BIONTECH,SYR 934333,CO,34.0,F,fever and body aches beginning at 2AM. treated with Ibuprofen with resulting reducting in fever but continued body aches/myalgias that lasted until 1pm on 1/10/21. Fatigue starting 5pm 1/9 and lasting until 5pm 1/10,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,"Nortrel, levothryroxin (88micrograms), fenofibrate (145mg)",,hypothryoidism,,shellfish,"['Fatigue', 'Myalgia', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934334,GA,50.0,F,"fever, chills, sore throat, difficulty swallowing, body aches, joint pain, hypertensive, tightness in chest. Went to ER @ Hospital",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PUB,,,"sickle cell, asthma, hypothyroid","flu & pneumonia-fever, swelling in arm","morphine, tramadol, sulfa, steroids,","['Arthralgia', 'Blood test', 'Chest discomfort', 'Chills', 'Dysphagia', 'Hypertension', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934335,KY,28.0,F,"Injection site redness large area with raised borders , hot to the touch",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,Sertaline 75mg Sprintec Tagamet,NO,NO,,NKA,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 934336,ND,53.0,F,"5am on 1/7 woke up with chills, bodyaches, fever, lethargy and headache. Lasted through day, temperature up to 101.5. On 1/8, temperature resolved, still bodyaches. On 1/9, symptoms resolving, but at 12:00pm temperature of 99.9 and fatigue. On 1/10 right deltoid where vaccine was administered, sight is warm to touch and swollen, painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,WRK,"Wellbutrin, Fiber pill, Milk Thistle, Pepcid","Elevated liver enzymes, possible ulcer",none,,Penicillin,"['Chills', 'Headache', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Lethargy', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934337,ND,44.0,F,"Covid vaccine administered in right deltoid on Dec 28. On Jan 9, 2021, client noticed a rash and warmth at the injection site. Does not itch, but has some discomfort with pressure.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/09/2021,12.0,PUB,,no,"atonic dystrophy, obesity",,prozac,"['Injection site pain', 'Injection site rash', 'Injection site warmth']",1,MODERNA,IM 934340,IL,63.0,F,Three hours after the vaccine I started developing chest pressure that lasted 45 minutes. After an hour after I had disnea rest which last 55 hours. I put a call into my patient care provider and went it to get a Coivd test that came back negative. I was told If it got worse to go to the emergency room . After the 55th hour I was back to normal.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,WRK,Lisinopril -20mg daily,,,,,"['Chest discomfort', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,SYR 934342,CA,37.0,F,balls palsy headache arm sore,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/08/2021,3.0,UNK,,,,,,"[""Bell's palsy"", 'Headache', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 934343,MA,96.0,F,"Left arm, red, tender to touch, warm, slightly swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/11/2021,3.0,UNK,AmLODIPine Besylate Tablet 5 MG Give 1 tablet by mouth in the morning for blood pressure Aspirin EC Tablet Delayed Release 81 MG Give 1 tablet by mouth in the morning for blood thinner Atorvastatin Calcium Tablet 10 MG Give 10 mg by mouth o,None,"Afib, Diabetes II, Hypothyroid, Hx of Covid 19, Anxiety, COPD, Parkinson, Dementia",,nka,"['Erythema', 'Feeling hot', 'Peripheral swelling', 'Tenderness']",UNK,PFIZER\BIONTECH,IM 934344,CA,51.0,F,Shortness of breath Arm pain Lump under left arm pit Pain goes across chest and down arm No fever Achy all over Left arm down to fingers and up the arm and across the chest to swollen arm under arm pit is in pain,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/10/2021,01/10/2021,0.0,UNK,,,Type I Diabetes with insulin pump,,,"['Axillary mass', 'Axillary pain', 'Chest pain', 'Dyspnoea', 'Pain', 'Pain in extremity', 'Peripheral swelling']",2,PFIZER\BIONTECH,SYR 934346,UT,52.0,F,"Symptoms started 1/4/21 @ 1800 with dry heaving, body aches, fever, then started coughing and shortness of breath that night. Next day still had fever, severe body aches and cough got worse with shortness of breath. I did home nebulizer several times and started prednisone 40mg. 1/6/21 shortness of breath worsened to the point I couldn't talk, chest tightness with burning. Went into ED at hospital where they gave me another breathing treatment x 2, magnesium sulfate, IV solu medrol. They were going to admit me but I decided against it with all the covid patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,Has inhalers and nebulizer for Asthma treatment. Unknown specifics.,,"Asthma - chronic, severe",,,"['Aphasia', 'Chest discomfort', 'Chest pain', 'Cough', 'Dyspnoea', 'Pain', 'Pyrexia', 'Retching']",1,PFIZER\BIONTECH,IM 934347,NE,32.0,F,"33 weeks gestation. sudden onset of upper abdominal pain, constant with palpable tenderness over b/l CVA, lower abdomen and upper abdomen. urine and labs normal. vitals normal, afebrile. sent to L and D to monitor. good fetal activity and cervix closed. sx gradually decreased and was able to go home but today 1/11 still with diffuse tenderness, worse with activity and some braxton hix contractions.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/08/2021,3.0,PVT,"iron, prenatal vitamin, linzess, zofran prn, protonix, valtrex prn",no,"GERD, Chronic constipation",,"morphine, latex","['Abdominal pain upper', 'Abdominal tenderness', 'Foetal monitoring normal', 'Full blood count normal', 'Metabolic function test', 'Pain', 'Pregnancy', 'Urine analysis normal', 'Uterine contractions during pregnancy']",2,PFIZER\BIONTECH,IM 934349,TX,36.0,F,"nausea and vomiting for 1 hour, approx. 15 hours after vaccine receipt. Accompanied by low grade fever (99.3F), chills, rigors, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,"Zoloft 50mg QD, Vitamin D 5000 units weekly",,,,,"['Chills', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 934350,CA,37.0,F,balls palsy headache sore arm,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/08/2021,3.0,UNK,,,,,,"[""Bell's palsy"", 'Headache', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 934351,MO,32.0,F,"1 week after vaccine administration (12/29/20), I developed diarrhea that has persisted for ~2 weeks at the time of this report and is ongoing. Currently pregnant with EDD 2/22/21. Uncomplicated pregnancy so far.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/29/2020,7.0,WRK,"Prevacid, Unisom, prenatal vitamin",none,GERD,,latex,"['Culture stool', 'Diarrhoea', 'Parasite stool test', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 934352,SC,23.0,F,"lymphadenopathy on left side of neck. It happened 5 days after first dose and has stayed swollen since first vaccine, but otherwise had no other issues. After she received her second vaccine, it has doubled or tripled in size and is painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/23/2020,6.0,WRK,celexa 20mg,no,no,,sulfa,"['Lymph node pain', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 934353,VT,68.0,F,"Burning/pain in throat, itching around mouth, wheezing, coughing, and BP 195/100. Taken to the ER, received epinephrine breathing treatment and Benadryl Observed for 2 hours then discharged. Slept most of the following day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Lexapro Allegra Omeprazole Advir Inhaler Advil,None,"Asthma, arthritis",,"Iodine - bees, shellfish, IVP Dye","['Cough', 'Oral pruritus', 'Oropharyngeal pain', 'Pruritus', 'Somnolence', 'Throat irritation', 'Wheezing']",1,PFIZER\BIONTECH,IM 934354,CA,27.0,F,Hives and lip filler swelling 1/11/21 at 8:30am,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/11/2021,2.0,OTH,"Biotin 10,000mcg qd Spironolactone 50 mg qd Adderall XR 10 mg qd Nutrafol",None,None,,None,"['Lip swelling', 'Urticaria']",1,MODERNA,IM 934355,WA,37.0,F,"C/O DIZZINESS/LIGHTHEADED, NO SOB, 905P 150/80,75,100%, 919PM 122/92,75,93% NO CHANGE, H/A, GIVEN H2O,926PM NO CHANGE, 946PM MORE H2O, 124/78,61, 97% NO MORE DIZZINESS STILL H/A FRIEND DROVE HER HOME, 01/08 AT 11AM HA NO DIZZINESS, TOLD TO CONTACT PCP OR 911 IF SYMPTOMS WORSEN",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,TAKING LISINPROL/HCTZ AND ASPRIN,none,hypertension,,none,"['Dizziness', 'Headache']",1,MODERNA,IM 934356,TX,48.0,F,"throat swelling, wheezing, headache, palpitations immediate, took 50mg Benadryl and 650 tylenol Q 12 hours x 2 days, Severe, debilitating joint pain starting second day lasting 3 days, low grade fever, pain and swelling to L deltoid. Swelling in arm lasted 10 days",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,"Lexapro 20mg/ norvasc 5 mg, MVI",High BP,High BP,,Lisinopril/ Wasp stings,"['Arthralgia', 'Asthenia', 'Headache', 'Injection site pain', 'Injection site swelling', 'Palpitations', 'Pharyngeal swelling', 'Pyrexia', 'Wheezing']",1,MODERNA,IM 934357,OK,44.0,F,"about 2 hours after injection I got very itchy, face, arms torso red and itchy lasted for twos even with Bendryl. End of second day had sore ""fiery"" throat. Felt like throat was on fire lasted for a week. Nothing made it better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,Lisinopril 10mg @0430 Mobic 10mg@0430,,HTN,,Sulfa,"['Erythema', 'Oropharyngeal discomfort', 'Oropharyngeal pain', 'Pruritus']",1,PFIZER\BIONTECH,IM 934358,TX,32.0,M,Myalgia began on 1/9/2021 mid day. Sunday 1/10/2021 at noon fever to 100.7. Symptoms since have resolved with no interventions.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,WRK,,,,,,"['Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934359,TN,34.0,F,"rash/hives (deep red) over chest, face, and ear treated with (1) benadryl 50mg capsule",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,Z-pak,"she was COVID negative the week of the vaccine, being treated for an upper respiratory infection and strep (even though strep was negative)",seasonal allergies and asthma (which flares up with seasonal allergies),,one allergy to an unknown medication last year; she had hives to it and nobody knew from what,"['Rash', 'Rash erythematous', 'Urticaria']",2,PFIZER\BIONTECH,IM 934360,CT,46.0,F,"Metallic taste to left side of mouth started at 4 pm on 1/8/2021 and continued until 1/9/2021@ 3am after Loratadine 10 mg po at 4pm and Allegra 180 mg at 9 pm. Left tongue numbness and tingling started at 4 pm on 1/8/2021 and continued until 1/9/2021 @ 3pm after Loratadine 10 mg po at 4 pm, Allegra 180 mg po @ 9 pm, and Benadryl 50 mg IM at 12 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Vitamin b12 Vitamin D3,None,"Diabetes, HTN, Anemia",,NKDA,"['Dysgeusia', 'Hypoaesthesia oral', 'Paraesthesia oral']",1,MODERNA,IM 934361,ND,35.0,F,One day following injection developed rash around the injection site. Since then reports continued rash that gets better then returns. Today the rash is faint per report.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/01/2021,1.0,PVT,,,,,,['Injection site rash'],1,MODERNA,IM 934362,CO,36.0,F,"Ten minutes after receiving injection patient started to feel like her throat was swelling, 20 minutes after started to turn red and having rash to neck",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Levothyroxine 200 mcg oral one tablet daily,,History of thyroid cancer,Had an anaphylactic reaction 20 plus years ago from an unknown cause,NKDA,"['Erythema', 'Pharyngeal swelling', 'Rash']",1,MODERNA,IM 934364,,33.0,F,"1). Headache (on &off) since 1/6. Tylenol and ibuprofen seem to be effective. 2). Fever with Temperature btn 99-100.3 these past three days. 3). Pulse (btn 104-110) the night of 1/6. 4). Muscle aches and swelling at injection site. This has been my biggest obstacle. I am having a hard time lifting and typing. . - I have been utilizing ice packs, range of motion/exercise, ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Headache', 'Injection site swelling', 'Mobility decreased', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934366,CA,57.0,F,Axillary lymph node swelling/pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/09/2021,3.0,OTH,Lisinopril 10 mg QD; metformin 500mg BID,None,Essential hypertension; glucose intolerance,,"Walnuts, macadamia nuts, cedar dust, cats","['Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 934368,WA,64.0,F,"Temp 100.8 Muscle aches headache sore throat sinus drainage fatigue sore arm lasted 2 days. Sore throat and sinus drainage lasted 3 days. Rest, fluids, Tylenol. Stayed home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/11/2021,6.0,WRK,Metformin Metoprolol Losartan Prozac Neurontin Atorvastatin CoQ10 B complex Vit D Vit C Calcium Multivitamin Low dose ASA Ibuprofen Tylenol,None,DM II HTN Fibromyalgia Depression,,PCN,"['Body temperature increased', 'Fatigue', 'Headache', 'Myalgia', 'Oropharyngeal pain', 'Pain in extremity', 'Sinus disorder']",1,MODERNA,IM 934369,CA,35.0,F,"About 10 hours after vaccine, patient developed nausea, vomiting, diarrhea, and abdominal pain. She describes these symptoms as severe with multiple, powerful episodes and similar to her Celiac disease when she flares from high gluten meal. She also had low back pain and body aches. The following day symptoms continued. Improved overnight into Jan 10, then worsened after waking up. On Jan 11, no further n/v/d but not feeling back to baseline yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,"Rituximab - last dose June 2020 Vitamin D - 2,000-5,000 units/day",None,MS Celiac Disease,,Gluten intolerance (Celiac Disease),"['Abdominal pain', 'Back pain', 'Condition aggravated', 'Diarrhoea', 'Nausea', 'Pain', 'Vomiting']",2,PFIZER\BIONTECH,IM 934370,AZ,64.0,F,"Patient had the vaccine on Friday (2:30pm) and was fine. Saturday then she had a sore arm. She went to work and was fine (10 hour shift). She had Gammagard around 6pm and then the infusion was fine and went on as normal (a little burning at the beginning), then chills at the end (not unheard of). An hour later she went to sleep since not feeling 100%. She woke up with severe chills, headache, body aches all over, She has bad chills and is shaky. She went home and no fever. Her eyes are kind of burning. She has a call with her doctor today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PUB,Gammagard,,,,,"['Chills', 'Eye irritation', 'Malaise', 'Pain', 'Pain in extremity', 'Tremor']",1,PFIZER\BIONTECH,IM 934372,GA,40.0,F,"At exact moment of injection, I had a metallic taste in my mouth. Immediately following injection, I felt lip tingling and numbness. I visited the ambulance on site, no treatment necessary per EMTs because I was without rash or lip/tongue swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Keppra Sertraline Primidone,None,Myoclonic seizures Anxiety/Depression IBS,,Penicillins Cephalosporins,"['Dysgeusia', 'Hypoaesthesia oral', 'Paraesthesia oral']",1,MODERNA,IM 934373,WV,82.0,F,"Patient went to bed around 11pm on Saturday PM and sometime between then and 1:30am on Sunday morning got up and went into the living room without waking up her husband (which is normal). At 1:30am, the husband got up to use the restroom and she was out of bed then, but the husband did not know if she was having any problems at this time. When he got up at 7:45am, she was in the recliner and did not move or anything, which is normal for her. At 8:45am, the husband went back into the living room and tried to wake his wife and that is when he noticed there was no pulse and he called 9-1-1 at this time. EMS got on scene and did CPR for 30 mins and she was pronounced dead at 9:21am.",Yes,01/10/2021,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PUB,Husband only knew that she took several medications.,Newly diagnosed heart murmur the week prior by PCP. Was referred to her cardiologist.,"She did have open heart surgery in 2013. She last saw her cardiologist 4 months ago, and she did a phone consult with him a week or so ago.",,PCN & Sulfa drugs,"['Death', 'Pulse absent', 'Resuscitation']",1,PFIZER\BIONTECH,IM 934374,IL,29.0,F,"Soreness at injection site began a few hours after administration. By the evening I began experiencing headache and an overall malaise feeling. This progressed into chills to the point of shivering and feeling feverish. Overnight I developed another headache and felt very mildly nauseous in addition to feeling fever/chills. Overnight I took 3 OTC Advil, was bundled up under multiple blankets, and got lots of rest. The next day I felt much better, only some fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,Daily prenatal vitamin,None,Ezcema,,Allergy to Vicodin and red food coloring,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 934375,,40.0,M,? Fever ? Chills ? Nausea ? Headache ? Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,none,none,none,,none,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 934376,NC,39.0,F,"Angioedema around both eyes approx 36 hours after shot. Prior to this, experienced arm pain around injection site and minor headache/fatigue. Angioedema took 3 days to go away. Saw Dr. and he recommended antihistamine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,None,none,none,,Childhood shellfish,"['Angioedema', 'Fatigue', 'Headache', 'Injection site pain']",2,MODERNA,IM 934377,,64.0,F,"I developed an erythematous rash over the injection site that and itchy, odd that it would happen over a week after the injection. The erythema measures 12 X 10 cm, almost like an urticarial plaque. I am not an itchy person.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/08/2021,8.0,UNK,Synthroid,none,none,,Ceftin,"['Injection site pruritus', 'Injection site rash', 'Rash erythematous', 'Urticaria papular']",1,MODERNA,IM 934378,CA,40.0,F,"This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/10/2021,0.0,WRK,,,,,,"['Dysgeusia', 'Dysphonia', 'Erythema', 'Flushing', 'Headache', 'Nausea', 'Rash erythematous', 'Swelling face', 'Throat tightness']",UNK,PFIZER\BIONTECH, 934380,OH,48.0,F,"Seven days after the vaccine was given to me, my right arm, where the injection was administered, was red, swollen and itchy. It was circular around the injection site about 2 inches in diameter. It was mild. Not much pain, but itchy. I took one dose of Benadryl on the second night and I applied hydrocortisone cream topically to the site for about two days. It lasted about 2 days. The Benadryl and hydrocortisone cream seemed to help.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/07/2021,7.0,UNK,"Multivitamin, calcium, Ester C- Vitamin C",None,None,,None,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 934381,TX,64.0,F,"8th Jan@1430-Tired 9th Saturday-tired, nauseated, aches, chills 10th Jan Sunday-nauseated, tired, chills, aches-body 11th Jan Monday-aches-body, tired, nauseated, Headache-Treatment-none, When she can she eats a little & drinks when not nauseated",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,MIL,Vitamins,none,none,,none,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,SYR 934382,WI,33.0,F,"After receiving the vaccine on 1/5/2021 I had no symptoms initially and for then next 2 days. On 1/8/21 at around 10:00am I got a headache of moderate severity behind my right eye and at right temple. It was associated with nausea and fatigue. I took 800mg ibuprofen and 4mg zofran. At 12:00 I left work and went home and slept for 4.5 hours between 12:30 and 5pm. I woke up at 5pm and had minimal residual headache in the right temple. After going to sleep from 8pm to 6am, I awoke on 1/9/21 and my headache was completely resolved. I do have a history of migraine headaches. This headache and associated nausea felt like my previous migraine headaches and the course was similar to my previous headaches.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/08/2021,3.0,PVT,No medications taken within 1 month prior to vaccination. Ibuprofen 800mg x1 and zofran 4mg x1 taken on 1/8/2021 for headache with nausea,none,Migraine headaches,,none,"['Fatigue', 'Headache', 'Nausea']",2,PFIZER\BIONTECH,IM 934383,MD,28.0,F,"Approximately 10 minutes after receiving the vaccine she started experiencing numbness and inability to move all 4 extremities. No difficulty breathing or swallowing. Benedryl 25 mg was administered with no relief. EMS was called, she was transported to the ED and admitted to the hospital for evaluation. She was given Ativan 0.5 mg IV with some mild improvement in symptoms. She has had gradual improvement in her symptoms, now able to move her arms normally. She has persistent weakness and discomfort in both lower extremities and is unable to ambulate without assistance.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,none,none known,obesity,,NKA,"['Blood creatine phosphokinase normal', 'Blood magnesium normal', 'Blood thyroid stimulating hormone normal', 'Borrelia test', 'Borrelia test negative', 'Full blood count abnormal', 'Gait inability', 'Human chorionic gonadotropin negative', 'Hypoaesthesia', 'Hypochromic anaemia', 'Limb discomfort', 'Lymphocyte percentage increased', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging spinal normal', 'Metabolic function test normal', 'Mobility decreased', 'Muscular weakness', 'Neutrophil percentage decreased', 'Red blood cell sedimentation rate increased', 'SARS-CoV-2 test negative', 'Scan with contrast normal', 'Treponema test negative', 'Vitamin B12 normal', 'Vitamin D decreased']",1,PFIZER\BIONTECH,IM 934384,TN,30.0,F,"Pain at injection site, constant, began ~2 hours after vaccine administration-time of VAERS submission Chills, duration from 3 AM-5 AM on 1/11/2020 ~14 hours after vaccine administration Generalized muscle aches, constant, began at 6 AM on 1/11/2020 - time of VAERS submission, ~ 17 hours after vaccine administration",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/11/2021,1.0,SCH,None,None,None,,None,"['Chills', 'Injection site pain', 'Myalgia']",2,PFIZER\BIONTECH,IM 934386,CA,33.0,M,Migraine that has lasted 4 days Blood pressure is going up and down chills nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/07/2021,2.0,UNK,,,,,,"['Chills', 'Migraine', 'Nausea']",1,MODERNA,SYR 934387,NE,17.0,M,slight sore arm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,None,None,None,sore arm,Penicillin,['Pain in extremity'],1,MODERNA,IM 934388,AR,25.0,F,"Severe lymphadenopathy (in armpits, very painful/tender), rash on left side of body (buttocks, side), nausea, extreme fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,OTH,,,,,,"['Axillary pain', 'Fatigue', 'Lymph node pain', 'Lymphadenopathy', 'Nausea', 'Rash']",1,PFIZER\BIONTECH,IM 934389,NM,36.0,F,Onset of palpitations within 2 hours of receiving second dose leading to a diagnosis and treatment of SVT with Adenosine that same day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Levothyroxine 125mcg daily,None,Chronic migraines,,None,"['Blood test', 'Electrocardiogram', 'Palpitations', 'Supraventricular tachycardia']",2,PFIZER\BIONTECH,IM 934390,VA,38.0,F,"The night of the shot I noticed a painful, red, swollen, arm and couldn't sleep on it. 24 hrs after shot I started to feel extreme fatigue, muscle aches, slightly sore throat, mild congestion. I had a temperature of 99.1. I went to an urgent care and my BP was elevated (very unusual for me) 140/100 and HR 110 and temp still 99.1. They did a rapid swab on me that was negative. I continued to feel awful the rest of the day. On Sunday the next morning I awoke because I had a very swollen and sore lymph node in my left armpit. I took tylenol and did warm compresses. I had continued fatigue on Sunday and slept the whole day. I also continued with a high heart rate 110-130 with activity. My Bp was 117/70I had a pulse oximeter at home. My temp stayed 99. Monday morning I woke up feeling better. My HR was in the 80 and temp 98.3 and fatigue is gone. I still have mild soreness in my left arm but the redness is fine and warmth is gone. My left armpit is still sore",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,None,None but my husband tested positive for Covid in 1/8/2020,None,,None,"['Blood pressure increased', 'Body temperature increased', 'Erythema', 'Fatigue', 'Feeling abnormal', 'Heart rate increased', 'Lymph node pain', 'Lymphadenopathy', 'Myalgia', 'Oropharyngeal pain', 'Pain in extremity', 'Peripheral swelling', 'Respiratory tract congestion', 'SARS-CoV-2 test negative', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 934392,CA,33.0,M,nausea chills migraine that has lasted 4 days,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/08/2021,3.0,UNK,,,,,,"['Chills', 'Migraine', 'Nausea']",1,MODERNA,SYR 934393,MO,71.0,F,"Angioedema of the lips. She had carpal tunnel surgery on 1/8/2021 and received lidocaine, propofol, and septra.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,WRK,,,,,,['Angioedema'],UNK,PFIZER\BIONTECH,IM 934396,TX,34.0,F,"Cellulitis at vaccine site. Lymph node sweeping under arm, redness spreading Steroids and antibiotic",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/08/2021,6.0,PVT,,None,Nons,,,"['Erythema', 'Injection site cellulitis']",1,MODERNA, 934397,KS,56.0,F,"Pt with complaints of disturbing nightmares since administration of the COVID-19 vaccine. Pt reports on 01/11/2021 to this RN that she had a couple nightmares after the first injection. Pt reports that she had two nightmares after the first dose. Since her second dose was received on January 8, 2021 she reports having disturbing night mares and requested reporting of the events. Pt declined evaluation at the clinic after notification of the event. Pt voiced she will follow-up with her PCP if the nightmares continue. Other side effects she reported with the second dose is nausea, tiredness, fatigue, headache, chills and some weakness. Those symptoms have since improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/11/2021,3.0,PVT,"Levothyroxine, Cymbalta",None,Depression,Pt had two nightmares after the first dose. Reported to staff on 01/11/2021,"Sulfa, TB test","['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Nausea', 'Nightmare']",2,PFIZER\BIONTECH,IM 934400,WI,33.0,F,"Immediately and for 2 days after receiving the vaccine, I had no symptoms. 1/8/2021 at 10:00am I developed a headache of moderate severity at right temple and behind right eye with associated nausea and fatigue. I took ibuprofen 800mg, zofran 4mg, and left work at 12:00pm. I was able to sleep from 12:30pm to 5:00pm and when I awoke, symptoms were improved with mild residual headache in left temple. After sleeping through the night, I awoke 1/9/21 and the headache and nausea had completely resolved. This headache was similar in quality and course to previous migraines that I have had and may get 1-2 times per year and have had since about age 12.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/08/2021,3.0,PVT,None at time of vaccination ibuprofen 800mg x1 and zofran 4mg x1 on 1/8/21,none,Migraine headaches intermittently,,none,"['Fatigue', 'Headache', 'Nausea']",2,PFIZER\BIONTECH,IM 934404,CO,23.0,F,"Immediately after receiving vaccine, patient became flush, experienced throat tightness, SOB, Epi 0.3 mg IM given. Patient transferred to ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/11/2021,0.0,PVT,,,,,,"['Dyspnoea', 'Flushing', 'Throat tightness']",UNK,MODERNA,IM 934406,MI,36.0,F,tingling to neck PO oral Benadryl 25 mg given,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,"pt approached obs and stated that stated that she is feeling better now but experienced tingling to neck, pt was offered Benadryl 25 mg and patient took medication with problem was able to swallow ok. Observed additional 15 mins and pt wen",none,none,,none,['Paraesthesia'],1,PFIZER\BIONTECH,IM 934407,CT,98.0,F,"1/8/2021 tachycardia Pulse 140, Fever T99.4 then 100.2 Lethargy, Somewhat Altered Mental status",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/07/2021,01/08/2021,1.0,SEN,"Tylenol, Artificial tears, Citrical with Vit.D, Ibuprophen, Multivitamin, Prosight, Soothe XP (light mineral oil-mineral oil) eye ointment","Pneumonia, Covid19","Schizophrenia, unspecified ,Vascular dementia without behavioral disturbance, Venous insufficiency (chronic) (peripheral), Hypo-osmolality and hyponatremia, Unspecified strabismus, Primary osteoarthritis, Unspecified blepharitis unspecified eye, unspecified eyelid",,"Propoxyphene, Unasyn","['Electrocardiogram PR prolongation', 'Full blood count', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Legionella test', 'Lethargy', 'Mental status changes', 'Metabolic function test', 'Polymerase chain reaction', 'Pyrexia', 'Streptococcus test negative', 'Tachycardia']",1,PFIZER\BIONTECH,IM 934408,CT,42.0,F,"After 15 minute waiting period, patient returned to work in healthcare system, reported flushing and difficulty swallowing. Patient presented to emergency department.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,"Tree nuts, iodine","['Dysphagia', 'Flushing']",2,PFIZER\BIONTECH,IM 934414,IL,69.0,F,"About 9 hours after the shot my left arm suddenly hurt a great deal. I noticed it when I went to raise up my arm a little bit. I also became exhausted. I realized I had been tired much of the first day but once my arm became so painful, I was completely exhausted. I felt out of sorts for about 36 hours and then began to feel normal again. It probably took a few more days to regain my energy completely.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,"asthma, Grave's disease",,"Sulpha, penicillin","['Fatigue', 'Feeling abnormal', 'Pain in extremity']",1,MODERNA,IM 934415,HI,44.0,M,"Pt was observed for 15 minutes after immunization and reported no immediate symptoms. That night, the patient ate salmon and mashed pototaes at 630pm. He reports arund 930pm, he developed stomach ache and one episode of diarrhea. Patient reports subsequent mild constriction in his throat and acute nasal congestion. Patient also reported acute onset of wheezing. He initially took his albuterol inhaler and took a puff of of Dulera without symptom improvement. He administered epinephrine IM at that point with immediate symptom improvement. He reports nasal congestion and wheezing resolved. Patient monitored symptoms at home. He did not seek medical attention. Unsure if reaction was related to salmon or COVID 19 vaccine. Patient will be assessed in clinci for a formal salmon oral challenge in the clinic. Patient will receive the 2nd shot COVID 19 vaccine and will bring epi pen with him to the clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Abdominal pain upper', 'Diarrhoea', 'Nasal congestion', 'Throat tightness', 'Wheezing']",1,PFIZER\BIONTECH,IM 934417,,78.0,M,"dizziness/vertigo, hypertension",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,"metoprolol, atorvastatin, aspirin, metformin, Vitamin D",None,Pre diabetes,,None,"['Dizziness', 'Hypertension', 'Vertigo']",UNK,PFIZER\BIONTECH, 934421,RI,47.0,M,"Tingling/burning down L arm, similar sensation down L leg; urticaria noted on back of neck extending slightly to L side of neck. Tachycardia and hypertension upon exam.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,MIL,Multivitamins,none,none,,NKA,"['Burning sensation', 'Hypertension', 'Paraesthesia', 'Tachycardia', 'Urticaria']",1,MODERNA,IM 934430,OH,46.0,F,"one week post injection, injection site became red, swollen and itchy. Rash last approx 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/07/2021,7.0,PVT,B vitamin complex,none,no,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Rash']",1,MODERNA,IM 934432,ID,60.0,M,"2 hours after receiving Pfizer COVID vaccine, vision in left eye presented with new floaters, flashes of light, and visual disturbance. Described as constant by patient, has not resolved 3 days s/p vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,none reported,none reported,none reported,,none reported,"['Intraocular pressure test', 'Photopsia', 'Retinogram', 'Visual impairment', 'Vitreous floaters']",UNK,PFIZER\BIONTECH,IM 934438,NE,80.0,F,"Volunteer received Moderna dose on 12/30 and then came in to receive 2nd dose on 1/6. Received Pfizer dose on the 6th. She states feels fine, no adverse side effects. Instructed NOT to come on 1/27, when her next appointment was scheduled.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,OTH,,,,,NKA,"['Inappropriate schedule of product administration', 'Interchange of vaccine products']",2,PFIZER\BIONTECH,IM 934439,TX,56.0,F,"Numbing of tongue, possibly mild Bell's Palsy, and occurred about 7 minutes after vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/11/2021,0.0,PVT,Benadryl,,,,Shellfish Ibuprofen,"[""Bell's palsy"", 'Hypoaesthesia oral']",2,PFIZER\BIONTECH,IM 934444,WI,42.0,F,"lient's tongue became swollen within 20 min. of vaccination. Swelling did not resolve by 4:00pm, client seen at urgent care. Client treated with Prednisone 60 mg PO x1; client prescribed Benadryl Q 4-6 hrs. x2 days, Prednisone 20 mg PO BID x5 days. Client developed generalized pruritis and lip tingling approximately 12 hrs. post-vaccination. Tongue swelling improved but not fully resolved at this writing (72 hrs. post-vaccination).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,DAILY MULTI-VITAMIN,,,TONGUE SWELLING AFTER FLU SHOT,"Clindamycin, sulfa, flu vaccines , environmental","['Paraesthesia oral', 'Pruritus', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 934445,OK,52.0,F,"52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccine received on 1.6. Patient has not worked since 1/6. Her symptoms started 1/7. She showed the provider a photo from her phone from 1/9 where her face was diffusely swollen and erythematous. She has not had dyspnea. She reports low grade fever off and on since vaccination. No n/v. She had stomach cramps for a whole, but those have fully resolved. At the visit on 1.11, her main symptoms are puffy eyes, and somewhat swollen and flushed face. Patient also reports dizziness, and still feels unsteady. Patient received a dexamethasone and depo-medrol injection in clinic on 1.11. Patient given return instructions. Provider will follow up in a few days to check on the patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,,,"Hypertension, pre-diabetes, Vit D deficiency",,NKDA,"['Abdominal pain upper', 'Dizziness', 'Flushing', 'Gait disturbance', 'Impaired work ability', 'Periorbital swelling', 'Pyrexia', 'Rash erythematous', 'Swelling face']",2,PFIZER\BIONTECH,IM 934450,IL,55.0,M,"C/O body aches, fatigue afternoon after vaccine. Following night had Fever 100.5, body aches. Fever decreased with tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,"Baclofen, Docusate, Finasteride, Omeprazole, Tamulosin, Vit D,",,"Thrombocytopenia, Barrett's esophagus, Hiatal hernia, GERD, BPH, splenomegaly, chronic constipation",,NSAIDs,"['Fatigue', 'Pain', 'Pyrexia']",1,MODERNA,IM 934451,NY,42.0,F,"Begining approx. 1/8/21, 11 days after the vaccine injection, the injection site is randomly very itchy and has a large red circle/ ring surrounding it. The red ring around the injection site is very large in size, about 3- 4 inches long and wide across my arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/08/2021,11.0,PUB,"Pantoprazole 20 mg, 1x daily mutli vitamin levothyroxine 25 mcg",none,none,,allergy to bee stings,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 934452,FL,67.0,F,"client was awaken early morning 2 days after covid vaccine with severe abdominal cramps and nausea. Called PCP and got prescription for meclizine that afternoon and that helped alleviate symptoms along with taking zofran, which client already had at home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,PUB,multiple,,"gout, hypertension, vertigo, type II diabetes",,sulfa,"['Abdominal pain', 'Nausea']",1,MODERNA,IM 934475,MI,57.0,F,"Her voice became raspy, she could hardly talk, she could barely talk; her hand and whole arm swelled up; her hand and whole arm swelled up; Trouble breathing; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EK9231, exp date Apr2021), via an unspecified route of administration in the right arm, on 29Dec2020, at single dose, for COVID-19 immunization and diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration, at unknown posology, on 29Dec2020 (20 minutes prior to taking bnt162b2), for anaphylactic reaction. Medical history included ongoing thyroid disorder. Concomitant medications included apixaban (ELIQUIS), diltiazem (unknown trade name), losartan (unknown manufacturer), rosuvastatin calcium (CRESTOR), levothyroxine (unknown trade name), ongoing levothyroxine sodium (SYNTHROID) for thyroid disorder and metformin (unknown trade name). Previously the patient received unspecified influenza vaccine (reported as flu shot) for immunisation, on unspecified date, and experienced anaphylactic reaction treated with Benadryl. On 29Dec2020, an hour after getting the vaccine, the patient experienced her voice became raspy, she could hardly talk, she could barely talk with outcome of unknown, her hand and whole arm swelled up with outcome of unknown, trouble breathing with outcome of unknown. The reporter stated that her voice and everything reacted and made her go to the emergency room on 29Dec2020. She reported that had adverse effect more than normal. The event ""Her voice became raspy, she could hardly talk, she could barely talk"" caused patient's hospitalization on unknown date. The action taken as a result of the events with diphenhydramine hydrochloride was post-therapy. Therapeutic measures were taken at the emergency room as a result of the events and included treatment with Topcid and Benadryl every 6 hours, 2x 40 mg of steroid. The information on the lot/batch number has been requested. Follow-up (02Jan2021): New information received from the same contactable healthcare professional reporting for herself includes: patient's details, medical history, events updated, vaccine lot# and exp date, concomitant, seriousness of event ""Her voice became raspy, she could hardly talk, she could barely talk"" added as hospitalization, historical vaccine, suspect Benadryl details, therapeutic measures updated.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,12/29/2020,12/29/2020,0.0,UNK,ELIQUIS; ; ; CRESTOR; ; SYNTHROID; BENADRYL,Thyroid disorder,,,,"['Anaphylactic reaction', 'Dysphonia', 'Dyspnoea', 'Peripheral swelling', 'Speech disorder']",1,PFIZER\BIONTECH, 934489,TX,59.0,F,"Rash entire body, throat swelling, extreme nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,,,,,,"['Nausea', 'Pharyngeal swelling', 'Rash']",UNK,PFIZER\BIONTECH,IM 934492,NC,35.0,F,"After vaccine became flushed across face and chest with racing pulse. Vitals taken, A&O x4; Answered questions appropriately. Pulse palpable and regular and fast. Given graham crackers and bottled water. Vital signs retaken along with blood glucose. VS- 114/101 HR 94 138/93 HR 91 Glucose 91 Declined offered escort to ED. A&O x4; speech clear, resp evan. No signs of surface reaction at left arm site. Suggested follow up with PCP. Explained VAERS to patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,MVI Prilosec,NKDA,NKDA,,NKDA,"['Blood glucose normal', 'Flushing', 'Heart rate increased']",2,PFIZER\BIONTECH,IM 934495,TX,62.0,F,"ACCORDING TO PATIENT STARTED WITH FEVER AFTER VACCINE THAT EVENING . THEN THE NEXT DAY SHE STARTED WITH SWELLING OF THE LIPS, TONGUE AND GUMS SO WENT TO ER WHERE SHE WAS GIVEN BENADRYL, TYLENOL AND STEROIDS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,,EAR INFECTION,"COPD, ASTHMA, HTN, DM, HEART DISEASE, RA, CHRONS DISEASE",,"PCN, KEFLEX, CEFZIL, CIPRO, CYMBALTA, TRIOLOGY","['Gingival swelling', 'Lip swelling', 'Swollen tongue']",1,MODERNA,IM 934496,GA,24.0,F,Vaccine administration at 1230; Tightening/itching of throat @ 1242; Benadryl 25mg/10mL administered at 1242; symptoms resolved shortly after,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PUB,,None,None,,"Shellfish, seafood","['Throat irritation', 'Throat tightness']",1,MODERNA,IM 934498,OR,32.0,F,"Pt felt a hot flush and heart racing about 5 mins after vaccination. BP 122/64, P 88-104, 96-99% O2 on RA. Denied SOB, throat tightening, cough, swelling of lips, tongue or face. Pt did become nauseous and had 2nd hot flush with HR going to 104. Pt transported to ED for evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/11/2021,0.0,PVT,unknown,none,unknown,,macrobid,"['Hot flush', 'Nausea', 'Palpitations']",1,MODERNA,IM 934500,MD,27.0,F,"Approximately 6 minutes after receiving vaccine, pt laid in supine position with knees bent. RN went to check on patient who reported headache with ""mild dizziness."" Patient was A and O x3 and denied difficulty breathing or SOB. HR 74, SpO2 99, and RR 17.Patient reports she had a smoothie this AM. Encouraged patient to remove mask, take deep breaths, and slow sips of water. Had patient remain in supine position for 10 minutes. VS reevaluated at 1236-SPO2 97, HR 69, BP 128/75, and RR 15. Patient reports improvement in symptoms. Encouraged pt to rest for 15 more minutes. Patient reports she ""is feeling better""-HR 73-SPo2 99. No difficulty ambulating-escorted to car by staff RN. Referred to PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,01/11/2021,0.0,PUB,,,,,,"['Dizziness', 'Headache']",1,MODERNA,IM 934502,IL,40.0,F,large red swollen around injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/10/2021,10.0,PVT,None,,,,None,"['Injection site erythema', 'Injection site swelling', 'Peripheral swelling']",1,MODERNA,IM 934504,IA,58.0,F,"Chills, Muscle Ache, Joint Ache, Head Ache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Myalgia']",1,MODERNA,IM 934507,MA,89.0,F,Resident died suddenly and expectantly on 01/05/2021,Yes,01/05/2021,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/05/2021,2.0,SEN,Coumadin 2mg po Sat-Mon-Tues-Thurs Coumadin 1mg po Fri Sun APAP 650 mg po PRN pain or temp above 101 Amiodarone 200mg po daily Ativan 0.5mg po PRN anxiety Claritin 10mg po daily Gabapentin 100mg po BID PRN phantom pain Miralax 17Gm po with,No other illness prior to vaccination or within the month prior,Covid 19 Recovered spring 2020 Chronic stage 5 kidney disease with dialysis 3 times weekly Chronic diastolic congestive heart failure Chronic A-fib Diabetes Mellitus with other circulatory complications Hypertension Right and Left Below the knee amputations,,KNDA KNFA,['Sudden death'],1,PFIZER\BIONTECH,IM 934510,WA,62.0,F,"9:10 p c/o of dizziness and lightheaded, 122/78, 97, 100% given H2O, rechecked at 9:25p V/S unchanged and dizziness and lightheadedness subsided. remained on site 30 mins. no symptoms, told to follow up with PCP or 911 if symptoms return",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,OTH,unknown,none,none,,unknown,['Dizziness'],1,MODERNA,IM 934515,IL,60.0,F,Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and moves. Diarrhea started 1-5-2021. No fever 97.7. Off work for 4 days. Using heating pad and inhalers. Has appointment with provider 1-5-2021 and 1-7-2021. Test for COVID on 1-7-2021 and negative Symptoms resolved 1-9-2021 and returned to work on 1-11-2021,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,ACIDOPHILUS; albuterol; ALPRAXOLAM; aspirin EC; clopidogrel; dicyclomine; dilTIAZem; fluticasone-salmeterol; folic acid; furosemide; ipratroplum-albuterol; ketorlac; lansoprazole; lisinopril-hydroCHLOROthiazide; Loratadine; Magnesium; metFO,None,"Asthma Diabetes, hypertension",,"cigarette smoke, seasonal","['Arthralgia', 'Chest pain', 'Diarrhoea', 'Impaired work ability', 'Muscular weakness', 'Pain', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 934539,KY,68.0,F,"Patient received COVID-19 (Moderna) vaccine from the Health Department on afternoon of January 8, 2021 and went to sleep approximately 2300 that night. Was found unresponsive in bed the following morning and pronounced dead at 1336 on January 9, 2021",Yes,01/09/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PUB,"Singulair, Oxybutynin, Fosamax, Prednisone, Meloxicam, Eliquis, Bumetanide, Triamcinolone cream, Klor-Con, Lisinopril, Promethazine,",Cellulitis of left lower limb (12/2020),Hypertension,,No known allergies,"['Autopsy', 'Blood test', 'Culture tissue specimen', 'Death', 'Toxicologic test', 'Unresponsive to stimuli']",1,MODERNA,IM 934559,WI,51.0,F,"Received dose 2hours post dose, itching throat, ears. facial swelling. Bendryl 50mg taken. Symptoms continued for the day of shot and day after shot. Day 2 additional Bendryl total 200mg taken before relief of symptoms. My PCP is aware of reaction and will place allergy on chart.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PVT,"vitamin D, Probiotic, benydryl, lexpro, Pepcid",,"Asthma, Allergys",,"Grass, trees pine, birch nightshades, mushroom, MSG, Sulfa","['Pruritus', 'Swelling face', 'Throat irritation']",UNK,PFIZER\BIONTECH,IM 934582,,38.0,F,"Experienced flushing and lightheadedness, required extended monitoring. Returned to work after 35 minutes of monitoring.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,01/11/2021,0.0,PVT,,,,,,"['Dizziness', 'Flushing']",1,PFIZER\BIONTECH,IM 934593,KS,36.0,F,"1/4 evening - Arm pain - Major Bump 1/5 11:45 Fatigue, body aches, chills, HA 1/6 ABOVE symptoms continue noted enlarged lymph node (L) clavical 1/6 ARM area w/ large bump - redness continues to get larger IBuprofen, Tylenol, Benadryl, Benadryl cream 1/7 Redness on arm continues Fatigue, BoDy aches, chills have stopped 1/8 - 1/11 ARM redness subsides; itching noted",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PUB,metoprolol xyzal omeprazole celexa Sprintec,none,Hypertension,,NKA,"['Chills', 'Erythema', 'Fatigue', 'Headache', 'Lymphadenopathy', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pruritus']",1,MODERNA,IM 934596,NY,42.0,F,"Reported skin was burning and itching. Provided with Benedryl, Pepsid, ice packs. Fever 102. Symptoms resolved except still feeling itchy. She contacted her PCP who told her not to take second dose. Referred to allergist.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Pruritus', 'Pyrexia', 'Skin burning sensation']",1,MODERNA,IM 934601,OH,47.0,M,"1/7 left work at noon, body aches, fever, night sweats, felt like covid all over again.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,,,none,,,"['Night sweats', 'Pain', 'Pyrexia']",1,MODERNA,IM 934605,PR,47.0,F,"At 4:43pm while in observation refers to itching in throat and bad taste in the mouth. Dr is notified who shows up immediately and evaluates, BP150/80mmhg Pulse 72/minute, Breaths 18/minute, afebrile, Communicative and alert in time place and space, not complications, is placed oxygen by nasal cannula at 3lt/min at 5:05pm by medical order be administered Benadryl 50mg IM in right deltoid under aseptic techniques and kept under observation, at 5:45pm goes out walking and in stable condition by medical order to her home in company co-workers, oriented at notifying any other event, verbalize understanding",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,none,none,none,,Aspirin,"['Taste disorder', 'Throat irritation']",1,PFIZER\BIONTECH,IM 934610,OR,49.0,M,Patient describes nausea with headache that started 36 hours after vaccine administration.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Took Omeprazole and ibuprofen for the symptoms of nausea and headache on 1/11/2021.,,None,,,"['Headache', 'Nausea']",1,MODERNA,IM 934656,,38.0,F,Experienced flushing and lightheadedness. Required extended monitoring. Patient returned to work after 35 minutes of monitoring.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,01/11/2021,0.0,PVT,,,,,,"['Dizziness', 'Flushing']",1,PFIZER\BIONTECH,IM 934676,WA,58.0,F,Chills Hip pain,Not Reported,,Yes,Yes,3.0,Not Reported,N,12/31/2020,01/02/2021,2.0,PVT,"Sertraline 25mg, Aspirin 81 mg, Calcium Citrate with Vitamin D3, Multivitamin with Iron, Hair Skin & Nails soft gel, Probiotic, Cetirizine",None,,,None,"['Arthralgia', 'Aspiration joint', 'Chills', 'Ultrasound joint']",1,PFIZER\BIONTECH,IM 934725,PA,33.0,F,"Rash, Facial flushing. Stabbing head pain Diarrhea (1-09-2021), Fever 100.4,Headache Took Loratadine and Benadryl - symptoms resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Enbrel Injection,none,Juvinile Rheumatoid Arthritis,,"Humera, Reglan","['Diarrhoea', 'Flushing', 'Headache', 'Pyrexia', 'Rash']",1,MODERNA,IM 934732,MN,45.0,F,"a red circle where I got the vaccine, it is still a firm nodule, itches lightly and is slightly warm (although I may just have warm skin in this office).",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/07/2021,9.0,SEN,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 934734,OH,44.0,M,Fever 100.3 Body aches Head aches Nausea Treatment: Naproxen and Tylenol,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,,,,,,"['Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 934740,TX,37.0,F,"extreme fatigue with, headache. Went to ER And Received fluids And meds for headache. SEEN IN E.D 1/7 & 12/19 (after both 1st & 2nd vaccine) ZOFRAN & FLUIDS IN E.D. DIAGNOSIS ""NEAR SYNCOPE""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,WRK,"Metoprolol, Keppra",,"seizures, Asthma",,NKDA,"['Electrocardiogram', 'Fatigue', 'Headache', 'Laboratory test', 'Presyncope']",1,PFIZER\BIONTECH,IM 934745,IA,79.0,F,"Resident had seizure like activity followed by a vagel response with large bowel movement. Resident then began to show signs of blood clot to left lower extremity. No pedal pulse, area on leg warm to touch. Left lower leg now cold to touch, stiff, purple and white in color. No other signs of modeling, body warm to touch, no fever noted. Respirations and pulse increased with low oxygen levels. Resident not responding to stimuli.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,SEN,"Exelon 13.3 mg daily, APAP 500 mg three times a day, Namenda 10 mg two times a day, Senna 8.6 mg two tablets daily, Mirilax 27 grams two times a day, 2 cal 4oz three times a day, Amlodipine 5 mg daily",,"Alzheimers, dementia, hypertension,",,NKA,"['Heart rate increased', 'Musculoskeletal stiffness', 'Oxygen saturation decreased', 'Peripheral coldness', 'Presyncope', 'Pulse absent', 'Respiratory rate increased', 'Seizure like phenomena', 'Skin discolouration', 'Skin warm', 'Thrombosis', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 934749,,38.0,F,"38-year-old female who is healthcare worker and received first dose of COVID vaccine (Pfizer). Immediately after receiving the vaccine, patient developed lightheadedness, flushing, hives, wheezing and throat swelling. Patient was treated in an emergency department with epinephrine, gradually improved and was able to be sent home with an EpiPen, prednisone, hydroxyzine, and famotidine. The next day, patient again developed shortness of breath and her husband administered the EpiPen. EMS arrived and gave another dose of IM epinephrine and IV diphenhydramine. On arrival to the emergency department, the patient was altered, diaphoretic, tachypneic, tachycardic, and stridulous. Patient was given multiple doses of IM epinephrine and started on epinephrine drip. Stridor continued and was unresponsive to nebulized albuterol. Patient was then intubated and placed on mechanical ventilation. Other treatments included solumedrol, pepcid, magnesium sulfate, nebulized epinephrine, and IV fluids. admitted to the intensive care unit, weaned off epinephrine drip, and extubated the next day. Patient was monitored on hospital floor for one additional day and was then discharged with no residual symptoms.",Not Reported,,Yes,Yes,,Not Reported,,,,,UNK,"Imitrex, Effexor XR, COVID-19 Vaccine (Pfizer)",,"GERD, Migraines, Anxiety, allergic to Reglan",,,"['Altered state of consciousness', 'Dizziness', 'Dyspnoea', 'Endotracheal intubation', 'Flushing', 'Hyperhidrosis', 'Immediate post-injection reaction', 'Intensive care', 'Mechanical ventilation', 'Pharyngeal swelling', 'Stridor', 'Tachycardia', 'Tachypnoea', 'Urticaria', 'Wheezing']",1,PFIZER\BIONTECH,IM 934754,FL,24.0,F,"Employee felt dizzy and lightheaded. Stated she ""felt like she was going to pass out."" Gave her orange juice placed her in Exam room lying down took B/P, O2 and Kept Eye on her. Dr. examined her and had her stay lying down for at least 30 mins. Employee was feeling much better and left at 4:00pm with someone to drive her home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,Zyrtec,None,None,,Codeine,['Dizziness'],1,MODERNA,IM 934755,,48.0,F,"Patient is a healthcare worker who received the COVID-19 vaccine (Pfizer). Within 1 hour of vaccine, patient began experiencing nasal passage tightness, nasal congestion, and facial numbness. No wheezing, rash, visible swelling, tachycardia, or hypotensions. Given diphenhydramine, famotidine, and prednisone in emergency department. During observation in ED, started having throat and chest tightness with hyperventilation. This improved with lorazepam. Patient felt improved and was discharged with Epi pen and told to follow-up with her allergist.",Not Reported,,Not Reported,Not Reported,,Not Reported,,,,,UNK,"cetirizine, fluticasone, ranitidine, COVID-19 vaccine (Pfizer)",,"chronic urticaria, recurrent angioedema, allergic rhinoconjunctivitis, medication allergies (amoxicillin, levofloxacin, nyquil, hydrocodone)",,,"['Chest discomfort', 'Dyspnoea', 'Hyperventilation', 'Hypoaesthesia', 'Nasal congestion', 'Throat tightness']",UNK,PFIZER\BIONTECH,IM 934756,MN,26.0,F,Noticed hives shortly after 1 woke up on 1/9/21. ~10am. Hives were white and all over legs and on back of my arms. Also had temp of 99.3..could be due to hives. Took benedryl and symptoms subsided 1/9/21 in the evening.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,"Fluoxetine, Bupropion, Cephalexin, Iron supplement, Biotin supplement",,,,sulfa medication,"['Body temperature increased', 'Urticaria']",1,MODERNA,IM 934758,TX,61.0,M,PATIENT PRESENTED TO ER ON 1/8/21 @ 6AM WITH STROKE SYMPTOMS INCLUDING (R) SIDE WEAKNESS,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/08/2021,4.0,PVT,"COREG, DIOVAN HCT, LASix, CiALis, MOBiC, ASA",,HTN MORBID OBESITY,,NKDA,"['Angiogram cerebral', 'Hemiparesis', 'Neurological symptom']",1,MODERNA,IM 934869,MI,83.0,F,"Patient had a rash prior to COVID vaccine. Prednisone 10mg started on 1/5/21 (only one dose administered) 1/6/21, 1am - Rash worsened with increase redness, warmth and extending of body surface, Temp 100.4, 1/6/21, 1:20am Benadryl 25mg administered, (Keflex was ordered at this time, however never administered). 1/6/21, 3am rash improved, temp 99.1 1/6/21, 6:50am Right facial droop and right sided weakness, sent to ER 1/6/21 transferred to hospital, continues to be hospitalized 1/11/2021",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,"Prednisone 10mg, Donepezil HCL 10mg, Breo Ellipta inhaler, Spiriva Inhaler, Plavix","Rash, Non hemorrhagic CVA in 2009, Alzheimer's dementia, COPD, HLD, CKD, Allergic Rhinitis","previous CVA, COPD, Alzheimer's dementia",,none noted,"['Body temperature increased', 'Condition aggravated', 'Facial paralysis', 'Hemiparesis', 'Rash erythematous', 'SARS-CoV-2 test negative', 'Skin warm']",1,MODERNA,IM 934877,PR,42.0,F,"Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergency room where apparently they diagnosed facial paralysis; Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergency room where apparently they diagnosed facial paralysis; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) intramuscular, on 17Dec2020 04:15, single dose arm left for COVID-19 immunization. Relevant medical history included hypothyroidism, hypertension, hyperlipidemia, obesity, and penicillin allergy. Concomitant medications included levothyroxine sodium (SYNTHROID), butalbital, caffeine, paracetamol (FIORICET 50-40- 325mg), dexamethasone 4mg Inj., diclofenac (VOLTAREN 1% Gel), Magnesium, valsartan (VASOFLEX) (pending confirmation), cyanocobalamin (VITAMIN B12), losartan potassium. The patient was not pregnant and did not received any vaccine in four weeks. The patient previously took cephalosporin and experienced allergy. On 24Dec2020, the patient experienced pain left side of the face and migraine, and came to emergency room where apparently they diagnosed facial paralysis. The events resulted in emergency room visit/ urgent care where the patient was administered dexamethasone 4mg Inj, Medrol dose pack, Vit B12 500mcg, and Fioricet 50-325-40. Facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. It was unknown if the patient was diagnosed with COVID-19 prior or since the vaccination. The events were assessed by the nurse as non-serious. Outcome of the events was recovering at the time of the report.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/24/2020,7.0,PVT,SYNTHROID; FIORICET; ; VOLTAREN [DICLOFENAC]; ; VITAMIN B12 [CYANOCOBALAMIN]; ; VASOFLEX [VALSARTAN],,"Medical History/Concurrent Conditions: Hyperlipidemia; Hypertension; Hypothyroidism; Obesity; Penicillin allergy (Allergies to medications, food, or other products: Penicillin / Cephalosporin)",,,"['Facial pain', 'Facial paralysis', 'Migraine']",1,PFIZER\BIONTECH,OT 934889,LA,93.0,F,HPI narrative: Patient was fine until 2 days ago. Patient does have chronic dementia but got Covid vaccine 11:00 2 days ago and that night seem to be confused and not able to walk since then. Patient poor appetite since yesterday. Patient had diarrhea 3 x 2 days ago. No vomiting no fever no cough does not appear to be short of breath. Patient also with left hip pain for few days with no injury.All history obtained from caretaker at bedside.,Not Reported,,Not Reported,Yes,,Not Reported,,01/07/2021,01/07/2021,0.0,PHM,citalopram 20 mg PO DAILY clonazepam 0.5 mg PO DAILY lisinopril 10 MG PO DAILY loratadine 10 mg PO DAILY magnesium oxide 400 MG PO BID memantine 5 MG PO BID metoprolol tartrate 25 MG PO BID pantoprazole [Protonix] 40 MG PO DAILY warfarin 4,,Afib Anxiety Arthritis CAD (coronary artery disease) Cervical vertebral fusion CVA (cerebral vascular accident) Frequent UTI Gastritis Glaucoma Heart attack Hyperlipidemia Hypertension Hypomagnesemia Insomnia Pancreatic mass Presence of inferior vena cava filter Psoriasis Pulmonary embolus Spondylolisthesis,,chlordiazepoxide [From Librium] ciprofloxacin [From Cipro] codeine diazepam meperidine morphine Nitrofuran Analogues ondansetron [From Zofran] oxycodone Penicillins pentazocine [From Talwin] propoxyphene [From Darvon] Sulfa (Sulfonamide Antibiotics),"['Arthralgia', 'Confusional state', 'Decreased appetite', 'Diarrhoea', 'Gait inability']",UNK,UNKNOWN MANUFACTURER, 934891,NV,53.0,F,"Started as a red raised rash under my arms and my waistline; rash turned to hot to touch; raised red large hives all over my body including my face/head; numbness to my hands/feet/chest area; the SOB started; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EU9231), via an unspecified route of administration in the left arm on 30Dec2020 at 08:30 as a single dose for COVID-19 immunization. Medical history included hypothyroidism and chronic low back pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), and etodolac (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took miconazole nitrate (MONISTAT) on unknown dates for an unknown indication and experienced drug allergy. On 31Dec2020 at 10:00, the patient started with a red raised rash under her arms and waistline and as the day progressed the rash turned hot to touch with raised red large hives all over her body including her face/head. By 23:00 on 31Dec2020, the patient had already taken 3 doses of diphenhydramine (BENADRYL) which was not effective. Then, later on 31Dec2020, shortness of breath started with numbness in the hands/feet/chest area. Her daughter took her to the emergency room. She was started on intravenous diphenhydramine, dexamethasone, and famotidine (PEPCID). The medications took time to work but they did resolve her shortness of breath and the hives subsided to mild redness. She was sent home and given the following medications to take: diphenhydramine 50 mg every 4 hours, methylprednisolone (MEDROL DOSE PAK), cetirizine (ZYRTEC) daily, and famotidine (PEPCID) daily. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the red rash, rash was hot to touch, shortness of breath, and numbness, were reported as recovered with lasting effects; while that of the hives was recovering as they still flared up if she did not take the medications every 4 hours. The reporter assessed all the events as non-serious.; Sender's Comments: The reported shortness of breath together with red rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE together with rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), due to temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,; ;,,Medical History/Concurrent Conditions: Back pain; Hypothyroidism,,,"['Dyspnoea', 'Erythema', 'Hypoaesthesia', 'Rash', 'Rash erythematous', 'Rash papular', 'Skin warm', 'Urticaria']",1,PFIZER\BIONTECH, 934893,PA,41.0,F,"Rectal bleeding; Stomach ache; Diarrhea; sick; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program Pfizer First Connect. A 41-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right arm on 20Dec2020 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. There were no concomitant medications. On 01Jan2021, the patient experienced: rectal bleeding, stomachache, diarrhea, sick; all assessed as medically significant. The clinical course was reported as follows: The patient received the first dose of the COVID-19 vaccine on 20Dec2020; as she was at high risk due to working with COVID patients in the hospital. The patient became sick on 01Jan2021. The patient experienced a stomach-ache, diarrhea, and rectal bleeding. When these events occurred, the patient went to the emergency room (ER). A doctor there prescribed the patient the antibiotics metronidazole 500 mg and cefdinir 300 mg. The patient was also scheduled to follow up with a gastrointestinal (GI) doctor. The patient called asking if she should get the second dose since she was taking antibiotics. The patient was scheduled for the second dose on 08Jan2020.The patient reported she had improved. The symptoms, at the time of the report, were not that bad. Therapeutic measures were taken as a result of rectal bleeding, stomachache, diarrhea, and sick. The clinical outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,01/01/2021,12.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE,,,"['Abdominal pain upper', 'Diarrhoea', 'Illness', 'Rectal haemorrhage']",1,PFIZER\BIONTECH, 934895,MI,55.0,F,"Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased BP; blood pressure was up and down; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) via an unspecified route of administration in left arm on 29Dec2020 6 am at single dose for covid-19 immunisation. Co-suspected drug amoxicillin;clavulanic acid (AUGMENTIN, Batch/lot number: KN4291, Expiry Date: Mar2022) by mouth from Dec2020 to 28Dec2020 at 875mg, 1 tablet twice daily for pain or infection; MOXIFLOXACIN HYDROCHLORIDE (AVELOX, strength:400mg) by mouth from 29Dec2020 and ongoing at 400mg, 1 tablet once daily for infection; fluconazole (DIFLUCAN, strength:200mg) orally (by mouth) from unknown date and ongoing at 200mg, 1 tablet once daily for Infection.The patient's medical history was reported as ongoing high blood pressure, ongoing pains in her fingers and toes and they thought she had an infection from 02Dec2020, white count went down on 09Dec2020, ongoing pain was up and down. No other vaccines given at that time and none given 4 weeks prior. Had a Flu shot back in Oct2020, but no problems. None diagnosed allergies and family medical history relevant to adverse event. The concomitant medications included unspecified blood pressure medication by mouth daily for high blood pressure. She had also started 2 antibiotics around the same time that she received the vaccine. No further details provided Was on antibiotics at the time she was given the Pfizer COVID-19 vaccine. Patient experienced increased BP/ high blood pressure, pain in head, and leg numbness; all started 2 days (on 31Dec2020) after receiving the vaccine and persisted for 48 hours. First her blood pressure was up and they had to get it stable and had numbness in her head, face, and mouth for 48 hours. Her blood pressure was up and down and she has history of blood pressure and takes medicine. Was taken off work for a few hours and went to the emergency department on Fri night about 2am. Her blood pressure was 170/92 on 01Jan2021. Not sure if this was related to the vaccine, but the numbness in her head started from her upper neck to face to the right side of her check and she also had leg numbness. Wanting to know if this was related because she was worried about getting the second dose. Had a hard time for 48 hours. Weight was between 150-155 pounds. Stated everything improved after 48 hours. Her lip was also just a little bit numb, but it is feeling better. Patient was feeling bad from 01Jan2021, all Fri and Sat and much better by Sun. Events of increased BP/ blood pressure up and down, leg numbness, numbness in lips, head, face, mouth with emergency room visiting. Wanted to know if she should have the second dose. The action taken in response to Augmentin was permanently discontinued on 28Dec2020, for Avelox and Diflucan was dose not changed. The outcome of events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,12/31/2020,30.0,PVT,AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]; AVELOX; Diflucan,Blood pressure high; Infection; Pain; Pain in fingers; Pain in toe,Medical History/Concurrent Conditions: White blood cell decreased,,,"['Blood pressure fluctuation', 'Condition aggravated', 'Feeling abnormal', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Impaired work ability']",UNK,PFIZER\BIONTECH, 934896,TX,36.0,F,"eventually inability to move arm; pain; joint pain; tenderness at injection site; loss of strength; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EJ1685) intramuscular at arm left, on 19Dec2020 06:45 at single dose for covid-19 immunisation. Medical history included ongoing acne. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included isotretinoin (ACCUTANE). On 19Dec2020 11:30, approximate 5 hours after vaccine, the patient experienced pain, joint pain and tenderness at injection site, progressively loss of strength and eventually inability to move arm. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was recovered.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,ACCUTANE,Acne,,,,"['Asthenia', 'Injected limb mobility decreased', 'Injection site joint pain', 'Injection site pain']",1,PFIZER\BIONTECH,OT 934898,TX,,F,"she is positive for blood in her stool; left hip/back/kidney pain; left hip/back/kidney pain; left hip/back/kidney pain; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 28Dec2020 (reported on 05Jan2021 as 'a week ago Monday'). After getting the vaccine (2-3 days after getting the vaccine) she started to have some events happen that she was not sure were side effects from the vaccine. She mentioned she started to experience blood in her stool - following a test at her doctor's she was positive for blood in her stool. Also, the left side of her lower back and hip started hurting. She was experiencing left hip/back/kidney pain, as reported. She took hydrochlorothiazide. The outcome of the events was unknown. She wanted to know if this had anything to do with the vaccine and if this could be a side effect. These events did not start happening until after she got the vaccine. Information on the lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,,,UNK,,,,,,"['Arthralgia', 'Back pain', 'Haematochezia', 'Occult blood positive', 'Renal pain']",UNK,PFIZER\BIONTECH, 934899,,,F,"difficulty of breathing; chest pain; nearly passing out/fainting; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter called in behalf of her friend that has been experiencing serious adverse event. The patient experienced difficulty of breathing, chest pain, nearly passing out/fainting on unspecified date. They felt that the vaccination provider did not provide enough support about the adverse event that happened. Follow-up activities are possible, information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Chest pain', 'Dyspnoea', 'Presyncope']",UNK,PFIZER\BIONTECH, 934900,CO,40.0,F,"believed it was injected incorrectly because she didn't have pain in her deltoid but she did have all the pain inside her shoulder, like in the bursa; received the first dose 17DEC2020 / received the second dose 4JAN2021; anterior medial shoulder joint/shoulder pain/pain in shoulder after second dose of COVID 19 vaccine; can't actively use shoulder / can't move her arm; weakness in her hand; bone pain; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiry date not provided) via an unspecified route of administration in the left arm on 17Dec2020 13:30, and the second dose (lot number EK9231, expiry date not provided)via an unspecified route of administration in the left arm on 04Jan2021 13:30, for COVID-19 immunization. There was no relevant medical history. The patient's concomitant medications were not reported. The patient experienced anterior medial shoulder joint/shoulder pain/pain in shoulder after second dose of the vaccine on 04Jan2021, and couldn't actively use shoulder. She believed it was injected incorrectly because she didn't have pain in her deltoid but she did have all the pain inside her shoulder, like in the bursa, and she couldn't move her arm and felt weakness in her hand. She noticed the pain and all other symptoms immediately when they were injecting it. She told the nurse who said she was tensing up. The events were considered medically significant by the patient. She also reported experiencing bone pain, unable to put in sutures at work. She was taking 600mg Ibuprofen and 1000mg paracetamol (TYLENOL) every 6-8 hours. The events were not resolved. The pain had gotten worse. The other symptoms were persisting.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/01/2021,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Bone pain', 'Immediate post-injection reaction', 'Impaired work ability', 'Injected limb mobility decreased', 'Injection site joint pain', 'Injection site pain', 'Muscle tightness', 'Muscular weakness']",2,PFIZER\BIONTECH, 934901,OH,92.0,M,SEVERE ABDOMINAL PAIN,Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/08/2021,01/09/2021,1.0,UNK,"APAP, amlodipine, metoprolol, ramipril, spironolactone, dutasteride, vitamin B12,",,"SCC, CHF, HTN, BPH, CARCINOMA OF COLON",,NKDA,['Abdominal pain'],1,MODERNA,IM 934902,WI,36.0,F,"tongue not swollen but felt sluggish/tongue felt strange, it was sluggish to swallow; tongue felt strange like hard to swallow/tongue felt strange, it was sluggish to swallow/Her tongue felt strange; tongue felt strange like hard to swallow/tongue felt strange, it was sluggish to swallow/felt hard to swallow; hot flash; flush feeling all over her face/flush all over her face/she felt flush; arm was sore; arm was sore and heavy; drowsiness; pain and redness at injection site; pain and redness at injection site; This is a spontaneous report from a contactable nurse reporting for herself. A 36-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiry date not provided) on 23Dec2020 09:15 intramuscularly in the left arm for COVID-19 immunisation (reported as preventive). There was no relevant medical history and no concomitant medications. The nurse (patient) received her first dose of the vaccine on 23Dec2020 at the hospital that she worked at. She was kept there for 15 min for monitoring and she felt fine. About 30 minutes post vaccination she got a hot flash, a flush over her face, she does not know if she was red but she felt flush. Her tongue felt strange, nothing swelled that she could tell, it felt hard to swallow, to make the motion to swallow it felt kind of sluggish. She felt weird swallowing which lasted for only a few minutes. She never struggled to breathe. She went back to park in the hospital parking lot since she was not sure if she was experiencing a anaphylactic reaction and then after a few minutes it went away. Her arm was sore and heavy feeling for that day. She had drowsiness for a couple of hours and pain and redness at the injection site for a couple of days that was not bothersome, it was mild. No relevant test. She wanted to know if she should get the second dose of the vaccine due to the symptoms she had after the first dose. The pain and redness at injection site was resolved on an unspecified date in Dec2020, while the other events were resolved on 23Dec2020. The reporting nurse considered the events hot flash, flush all over her face, arm was sore and heavy, drowsiness, pain and redness at injection site were non-serious, while the events ""tongue felt strange, it was sluggish to swallow"" were serious that she drove back to the hospital (no emergency room/phycian office visit). She considered the events were related to the vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162Bw on the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dysphagia', 'Flushing', 'Hot flush', 'Injection site erythema', 'Injection site pain', 'Limb discomfort', 'Pain in extremity', 'Paraesthesia oral', 'Somnolence', 'Tongue movement disturbance']",1,PFIZER\BIONTECH,OT 934904,PR,42.0,F,"Facial paralysis; stress; This is a spontaneous report from a contactable Nurse. A 42-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter felt worried about the patient(partner) that had facial paralysis and asked if they could administer the second dose of the vaccine of covid-19 from Pfizer. The paralysis it was previous from the fist dose of the vaccine, a consequences of the stress, the partner had 42 years. The reporter considered that the event was non-serious. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Facial paralysis', 'Stress']",1,PFIZER\BIONTECH, 934906,PA,57.0,F,"experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elevated blood pressure; This is a spontaneous report from a contactable Other-HCP(Patient). A 57-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm, on 22Dec2020 08:15 at single dose for COVID-19 immunization. The patient was not pregnant. Medical history included herpes simplex on lips, post menopause, elevated cholesterol w/lifestyle changes. Known allergies reported as no. Concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) for immunization. On 04Jan2021 08:30, the patient experienced symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure. The patient admitted to (Hospital name) (still here, hospitalization days reported as 2). Symptoms resolved except very mild aphasia. The patient had very few risk factors for TIA but did have family history of cardiovascular(CV) disease at young age, low density lipoprotein(LDL) was 192. The patient did not have diabetes, HTN, or known heart disease. She did not have severe anxiety. She did not smoke or use any substances. She walked about five miles 4x a week. Weigh reported as 157. Events reported as serious due to hospitalization. The patient had no Covid prior vaccination. Covid(nasal swab) was tested post vaccination on 04Jan2021, Covid test result was Negative. The event resulted in emergency room/department or urgent care. Treatment received for the adverse event included clopidogrel bisulfate(PLAVIX), acetylsalicylic acid (ASPIRIN), statin; potassium, CT, MRI, ""telemet"". The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure and the administration of BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, Agency, as appropriate.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/22/2020,01/04/2021,13.0,PVT,SHINGRIX,,"Medical History/Concurrent Conditions: Cardiovascular disease, unspecified (family history of cardiovascular(CV) disease at young age); Cholesterol blood increased (elevated cholesterol w/lifestyle changes); Herpes simplex (Herpes simplex on lips); Menopause (post menopause); Non-smoker",,,"['Amnesia', 'Aphasia', 'Blood pressure increased', 'Computerised tomogram', 'Confusional state', 'Low density lipoprotein increased', 'Magnetic resonance imaging', 'SARS-CoV-2 test negative', 'Transient ischaemic attack', 'Vision blurred']",1,PFIZER\BIONTECH, 934907,NM,,M,"two skin procedures performed in his surgeons office the day before- one on his nose and one on his arm; nose was still slightly bleeding; This is a spontaneous report from a contactable consumer(patient). �A 72-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. Medical history included phlebotomy in Sep2020 because his blood was ""too thick"" and he had no history of a clotting problem until the time of the report. The patient's concomitant medications were not reported. He reported having two skin procedures performed in his surgeons office the day before- one on his nose and one on his arm. The surgeon nicked a vein on his arm and it began bleeding again last night. The arm was addressed in the emergency deportment(ED) and was fine at time of the report. His nose was still slightly bleeding. This morning his blood was drawn for a CT scan and it took a little while to get the bleeding to stop. He had a ""phlebotomy"" in Sep2020 because his blood was ""too thick"" and he had no history of a clotting problem until the time of the report. The patient asked if the Covid vaccine act as an anticoagulant. He had not spoken to this HCP yet. He was not on a blood thinner. The reporter considered that the event was non-serious. The outcome of the event arm bleeding/bleeding was recovered, of event ""nose was still slightly bleeding"" was not recovered. � Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,,,UNK,,,"Medical History/Concurrent Conditions: Phlebotomy (because his blood was ""too thick"" and he has no history of a clotting problem until today)",,,"['Coagulopathy', 'Computerised tomogram', 'Condition aggravated', 'Epistaxis', 'Haemorrhage']",1,PFIZER\BIONTECH, 934909,CO,59.0,F,"soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 of 101.3; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; had joint pains/knees and hip joint pain; severe fatigue; muscle pain; This is spontaneous report from a contactable nurse (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in right arm on 30Dec2020 14:15 at first single dose (0.3 cc, but really uncertain of dose) for covid-19 immunization. Medical history included COVID virus from Nov2020 to 2020 (The patient was not hospitalized. It was a mild case and lasted about 10 days. she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue). The patient's concomitant medications were not reported. The patient did not receive any other vaccines at the same time or 4 weeks prior. No problems with vaccinations in past or events. Caller reported she had the first injection of the Pfizer BioNTech COVID-19 vaccine on the 30Dec2020 and having some side effect symptoms and her supervisor recommended for her to report these things, they are not life threatening, obviously, but things were still lingering. Side effect of severe fatigue started on the 31Dec2020 and lasted for 72 hours. It was so severe, now it is mild. The patient reported soreness around the injection site. Had a fever on the night of the 31Dec2020 of 101.3 and had that for 6 hours then it dissipated and was gone. Had never had a fever after injections before. Had severe arm pain that usually goes along with an injection. It started also that night of 31Dec2020. She had rolled over in the middle of the night and it hurt. That lasted for about 48 hours, but it has improved. Had some muscle aches since 31Dec2020 but that had improved and had joint pains since 31Dec2020. What was worrisome was the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes, since 31Dec2020. The patient was still having that and that is why she was so concerned because shouldn't that have gone away after a week. Had knee and hip joint pain, but that had improved. Again, mentioned she had never had that before with an injection. The patient received vaccine at her workplace. Some of her coworkers got it the same day and no one else has this. Mentioned she did have COVID virus back in Nov2020 and wonders if this correlates with her getting the vaccine. Was not hospitalized or notified she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue. This is the same way she felt back when she had the virus back in November. The patient was concerned about having these side effects would it be okay for her to get the next injection in 3 weeks. AEs did not require a visit to emergency room and physician office. No further details provided. Outcome of the events Fever was recovered, of event swollen and painful lymph nodes was not recovered, of events knees and hip joint pain, fatigue, muscle pain, severe arm pain was recovering, of event soreness around the injection site was unknown. The reporter considered the events severe fatigue, fever, swollen lymph nodes and pain under right arm, knees and hip joint pain as serious (medically significant). The reporter considered the events severe fatigue, fever, severe arm pain, muscle ache, swollen lymph nodes and pain under right arm, knees and hip joint pain as related to BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,,,"Medical History/Concurrent Conditions: COVID-19 (The patient was not hospitalized. It was a mild case and lasted about 10 days. she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue)",,,"['Anxiety', 'Arthralgia', 'Fatigue', 'Injection site pain', 'Lymph node pain', 'Lymphadenopathy', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH, 934910,CA,53.0,F,"chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had near syncope that would come in waves every 2-3 minutes; Headache; rapid HR; Chills; mild cough; Dizziness; fatigue; This is a spontaneous report from a non-contactable health care professional nurse, the patient. A 53-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), in the right arm on 28DEC2020 08:15 as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a Hospital. Medical history included asthma and gastroesophageal reflux disease from an unknown date and unknown if ongoing. Known allergies include Tape, Walnuts, and Cat hair. Concomitant medication received within 2 weeks of vaccination included acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]), ferrous gluconate, herbal nos, vitamins nos (FLORADIX), lansoprazole (PREVACID), cholecalciferol (VITAMIN D [COLECALCIFEROL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28DEC2020 08:15 within 2 min. of injection had near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR. The patient Spent 1 hour in ER. Later in day 28Dec2020, continued to have dizziness, chest pressure, chills, headache, fatigue. This continued for 4 days and had mild cough. The adverse events resulted in an emergency room (ER) visit. and Physician Office Visit. Treatment included Xyzal which relieved majority of symptoms. Laboratory test and procedures on 28Dec2020 include Electrocardiogram (EKG) with normal results, Blood Pressure Measurement 186/90 and Heart Rate Rapid. Treatment was given for chest tightness, throat tightness and red face and No treatment was given for chills, cough, dizziness, fatigue, headache, heart rate increase, blood pressure high and near syncope. The clinical outcome of near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR, dizziness, chest pressure, chills, headache, fatigue, mild cough was recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported face red, chest pressure, tightness /pressure in throat, blood pressure increased (BP 186/90), near syncope and the administration of BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,ACYCLOVIR [ACICLOVIR]; FLORADIX; PREVACID; VITAMIN D [COLECALCIFEROL],,"Medical History/Concurrent Conditions: Adhesive tape allergy (Known allergies: Tape, Walnuts, Cat hair); Allergy; Allergy to nuts (Allergies to medications, food, or other products: tape, walnuts, cat hair); Asthma; GERD",,,"['Chest discomfort', 'Chills', 'Cough', 'Dizziness', 'Electrocardiogram normal', 'Erythema', 'Fatigue', 'Headache', 'Heart rate increased', 'Hypertension', 'Presyncope', 'Throat tightness']",1,PFIZER\BIONTECH, 934912,FL,28.0,F,"DVT; have pain in same site where DVT is; This is a spontaneous report from a contactable consumer. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9291), via an unspecified route of administration in left deltoid on 24Dec2020 10:00 at first single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. Caller was calling to report a possible adverse reaction to the Pfizer Covid-19 vaccine. The patient was currently at hospital, she was admitted for deep vein thrombosis (DVT) of left iliac vein, the patient had no past history as to why this would happen, that she is only 28 years old. Received the vaccine on 24Dec2020, the following day she did have pain in same site where DVT was. Took ibuprofen for the pain. The patient was admitted yesterday 04Jan2020 for the DVT, they were currently treating her with Lovenox injections and prescribing dose for discharge is Eliquis. CT scans and three shots of Lovenox for it, doing a doppler of bilateral legs and echocardiogram (echo) of her heart to make sure there is nothing else. The AEs require a visit to emergency room. The patient was asking if she can still get the 2nd dose based off the adverse event she experienced. Outcome of DVT was not recovered, of pain was unknown.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/24/2020,01/04/2021,11.0,MIL,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Computerised tomogram', 'Echocardiogram', 'Pain', 'Pelvic venous thrombosis', 'Ultrasound Doppler']",1,PFIZER\BIONTECH, 934913,AZ,51.0,F,"Chills; Headache; Coughing; Tiredness; Nasal congested; Feels like her sinus were blocked; Body ache; feeling sick; Sneezing; This is a spontaneous report from a contactable nurse (patient, front line health care worker). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EH9899) via an unspecified route of administration in the left arm on 28Dec2020 (at 10:30 or 11:00 AM) at single dose for COVID-19 immunization. Medical history included hypertension, diabetes, and stroke, all reported as family history (her parent). There were no concomitant medications. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no additional vaccines administered on same date of the Pfizer suspect. The patient did not have prior vaccinations within 4 weeks. The patient had body ache (reported as medically significant) on 01Jan2021 with outcome of recovering, had been sick for a week/ very ill on 28Dec2020 with outcome of unknown, sneezing on 28Dec2020 with outcome of not recovered, chills on 01Jan2021 with outcome of unknown, headache on 01Jan2021 with outcome of recovering, coughing on 01Jan2021 with outcome of not recovered, tiredness on 01Jan2021 with outcome of unknown, nasal congested on 01Jan2021 with outcome of not recovered, feels like her sinus were blocked on 01Jan2021 with outcome of unknown. Treatment was received for the events. Reported she had a lot of sickness, by evening that day (28Dec2020) she got sneezing and feeling sick. Then the next day was the same, then the third day. She became very ill with chills, body ache, headache, coughing, and tiredness on 01Jan2021 (also reported as 3 days later vaccination). And she had no fever, but stated she had been sick for a week. Added the headache and body ache were a little better but still she felt so congested. Clarified she had nasal congested that feels like her sinus were blocked. She treated herself with acetaminophen, once daily 500 mg by mouth starting 01Jan2021. Added the body ache pain was still on the back of her chest but her legs and arms were better. She used steam inhalation for the congestion. She was not scheduled for the next dose yet, she was just waiting. The patient was wondering if she should do a test for COVID 19. Mentioned she had been healthy all through this year and digging in the COVID 19 all the time but then after the vaccine she got so sick. This was the first day she could get up and did anything. Advised caller to consult her HCP.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the body ache. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Diabetes (her parent); Hypertension (her parent); Stroke (her parent),,,"['Chills', 'Cough', 'Fatigue', 'Headache', 'Malaise', 'Nasal congestion', 'Pain', 'Sinonasal obstruction', 'Sneezing']",1,PFIZER\BIONTECH, 934915,,,F,"TB test; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that received received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. Certified Nursing Assistant got the first dose of the covid vaccine on January 2nd and also she needs to get her TB test. She was told to wait 2weeks between the application and the TB test but the 2 weeks period ends on January 15th and she needs to have the test before that day, so she was wondering if she could get the test done a couple of days early. The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,,,UNK,,,,,,['Mycobacterium tuberculosis complex test'],UNK,PFIZER\BIONTECH, 934918,VA,37.0,F,"2 week migraine; headache; flushed/Got flushed; persistent extreme dizziness; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EK5730, Intramuscular at single dose on 17Dec2020 19:00 on right arm for precaution as front line health care worker. Medical history included Hemiplegic migraine. Her mother also had migraines. Concomitant medication included ranitidine hydrochloride (ZANTAC) and H1 and H2 blocker. The patient called to report AE of flushed, persistent extreme dizziness, and a headache that has evolved into a 2 week migraine. She has a history of hemiplegic migraines and was taking and h1 and h2 blocker when she received the vaccine. She was calling on guidance whether or not to receive the second vaccine. She was scheduled for second dose on Thursday, but wanted to speak with someone before she got it to see if it was OK. About 15 minutes after receiving the first dose, she got flushed and extremely dizzy. She had a mild headache when she woke up on 18Dec2020 06:00, which then developed into a severe migraine on 22Dec2020 08:00 that she has had for 2 weeks and dizziness continues. She received it at work and there was no prescriber. She called and left a message with Pfizer but has not heard back from anyone yet about this. She would say the flushed and dizziness would be medically serious because she had allergies and had medication on board. She takes daily allergy medication and Zantac and not sure she would not have had a worse reaction if she hadn't had that on board. She took it every night. She had an H1 and H2 blocker on board. Flushed has improved but the dizziness has stayed constant. She had been treated twice for headache and now they have put her on a Prednisone taper. She got it on her right arm so she could work her arm out. On 22Dec2020, she saw a Neurologist for the Migraine. They gave her Toradol 30 mg and Zofran 4mg injection in office. They were given IM. Then, she had another office visit for urgent care on 02Jan2021, and that was for the exacerbation of the migraine. They prescribed 1 liter of fluids and then another Toradol injection, Zofran injection and Decadron injection. The dose of the Toradol was 30 mg, Decadron was 6 mg, and Zofran was 4mg. These were given IV in urgent care. The patient had no prior vaccinations within 4 weeks. The outcome of flushed/Got flushed was resolving. The outcome of other events was not resolved.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events flushing, dizziness, headache and migraine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/17/2020,0.0,PVT,ZANTAC,,Medical History/Concurrent Conditions: Hemiplegic migraine,,,"['Condition aggravated', 'Dizziness', 'Flushing', 'Headache', 'Migraine']",1,PFIZER\BIONTECH,OT 934919,,,M,"syncope; diaphoresis; varying HR; blurred vision; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 05Jan2021 as single dose for COVID -19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced syncope, diaphoresis, varying HR (heart rate) and blurred vision in Jan2021. The patient underwent lab tests and procedures which included heart rate: varying in Jan2021. Details were as follows: Patient received the vaccine in the morning. He reported diaphoresis, syncope, varying HR, and blurred vision within 10 minutes of receiving the vaccine. He was taken to the emergency room and therapeutic measures were taken as a result of the events; he was given fluids. The patient generally tolerated vaccines and has recovered from the episode. The events, syncope, diaphoresis, varying HR (heart rate) and blurred vision recovered in Jan2021. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event due to temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/01/2021,,UNK,,,,,,"['Heart rate irregular', 'Hyperhidrosis', 'Syncope', 'Vision blurred']",UNK,PFIZER\BIONTECH, 934920,NM,72.0,M,"one of those biopsies was bleeding pretty heavy/looked at the incision/The one on his nose is still dripping blood and its coming up on 24 hours now; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: E70124), Intramuscular in arm on 30Dec2020 at single dose for COVID-19 vaccination. Medical history included ongoing blood pressure high and he had been treated for that for a number of years, diabetes from 2009 and ongoing, COPD (chronic obstructive pulmonary disease) issues from 2020 and ongoing and his issues began within the last year, ongoing kidney failure and this started occurring within the last 2 or 3 years, had a urostomy done, had bladder cancer and he had had phlebotomy performed around 3-4 months ago in 2020 and he knew his blood was thick at the time. There were no concomitant medications. The patient received the first vaccine on Wednesday, 30Dec2020. He had noticed something. He had a couple of things happen that basically involved a couple of skin biopsies. He had some lab work drawn for a CT scan, and he didn't clot right away on 05Jan2021. Last night 04Jan2021, he went to the emergency room because one of those biopsies was bleeding pretty heavy. He wanted to know if there is any known connection with the COVID vaccine and anti-clogging. He was going to follow up with the surgeon that did the biopsies. He stated its weird. He had had phlebotomy performed around 3-4 months ago in 2020 and he knew his blood was thick at the time. There had been 2 or 3 incidents where he was not clogging up. He clarified they were skin cancer biopsies, which was something diagnosed prior to receiving the vaccine. It was a follow-up because they didn't get it all the first time and they had to go back in. His skin biopsies were done yesterday, 04Jan2021. He verified when he went to the emergency room last night 04Jan2021 he was not admitted into the hospital. It was outpatient and they looked at the incision and put a little clotting tape (or whatever it is) on him and wrapped it up. He hadn't been bleeding. He knew the doctor nicked a vein. There were 2 biopsies done- one was on his nose. The one on his nose was still dripping blood and its coming up on 24 hours now. The blood drawn for the CT scan was drawn early this morning 05Jan2021 around 7:30 AM. The outcome of the event was not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,UNK,,Blood pressure high (Caller states he has been treated for that for a number of years); COPD (Caller states his issues began within the last year); Diabetes; Kidney failure (This started occurring within the last 2 or 3 years . He had a urostomy done. He had bladder cancer),Medical History/Concurrent Conditions: Bladder cancer; Phlebotomy (He has had phlebotomy performed around 3-4 months ago and he knows his blood was thick at the time.); Urostomy,,,"['Biopsy skin', 'Blood test', 'Coagulopathy', 'Computerised tomogram', 'Post procedural haemorrhage', 'Skin haemorrhage']",1,PFIZER\BIONTECH,OT 934921,WA,41.0,F,"Pateint reports feeling tightness in throat she did take Benadryl, was talking in full complete sentences Denies hives, denies swelling on mouth or SOB SHe called 911 no epi provided",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Loestrin 1.5/30 Benadryl PRN,Mild Intermittent Asthma HX of non melanoma skin Cancer,,,"NKDA, NK Food Allergies",['Throat tightness'],UNK,MERCK & CO. INC., 934922,TX,39.0,M,"Followed by neurological symptoms staring day 4; parasthesias of both upper extremity; progression to muscle weakness of all four extremities/Currently with significant muscle weakness, Left hand weakness leading to dropping of objects and left foot drop; progression to muscle weakness of all four extremities/Currently with significant muscle weakness, Left hand weakness leading to dropping of objects and left foot drop; Flu like symptoms first 3 days; This is a spontaneous report from a contactable physician (patient). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ek5730) at left arm, via an unspecified route of administration on 16Dec2020 at single dose for covid-19 immunisation. Medical history included hypertension, diabetes, migraines, Eosinophilic granulomatosis with polyangiitis (EGPA) remission. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 21Dec2020, the patient experienced flu like symptoms first 3 days. Followed by neurological symptoms staring day 4, parasthesias of both upper extremity with progression to muscle weakness of all four extremities. Leading to 2 ER visits and hospital admission. Evaluation by internal medicine, neurology and rheumatology. Currently with significant muscle weakness, Left hand weakness leading to dropping of objects and left foot drop. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The treatment for events included High dose steroid. Covid test included Nasal Swab: negative on 19Dec2020. The outcome of events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events influenza like illness, neurological symptom, paraesthesia, muscular weakness and peroneal nerve palsy cannot be excluded. The information available in this report is limited. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,3.0,Yes,N,12/16/2020,12/21/2020,5.0,PVT,,,Medical History/Concurrent Conditions: Diabetes; Eosinophilic granulomatosis with polyangiitis; Hypertension; Migraine,,,"['Influenza like illness', 'Muscular weakness', 'Neurological symptom', 'Paraesthesia', 'Peroneal nerve palsy', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 934924,OH,58.0,F,"tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head on wall, head just hurts; hit head on wall, head just hurts; Chills; she was very cold; could not sleep good; site of vaccine was sore; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EK9231) by injection once to left arm, via an unspecified route of administration on 04Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder; patient started it after she had her son, and her son is 18 years old. The patient had her vaccine yesterday (04Jan2021) at 12:30, and at nighttime, around 22:00, she started having chills, she was very cold, so she went to bed, she could not sleep good, she kept waking up, and the site of vaccine was sore, she had muscle pain, joint pain, she didn't have fever, but she got up late today (05Jan2021), around 11:00, and had breakfast and felt nauseated, so she stopped eating, and she went to the bathroom and passed out on the toilet, when she woke up, she had her nightgown inside the toilet, it was all wet, she felt better, so she stood up and then she woke up again, and was inside the tub, her legs were inside the basin, she was lying down with her back inside the tub, she thinks she hit her head on the wall, and it just hurts, it didn't bleed or nothing. The patient stated she had the paper she was given. Again stated she can not even function. Patient still feels Chills a little bit, not as bad as last night. She is awake now, but she feels very very tired, like she has no energy, she is laying down on couch right now. She kept waking up and noticed this morning, she had low back pain, in the muscles, even her fingers are hurting. Regarding hitting her head on the wall, states she has a terrible headache, not a little pain, she thinks it is because she hurt her head. The patient is supposed to get second vaccination on 25Jan2021. The outcome of events Chills, Joint pain and nauseated was recovering; of events site of vaccine was sore and muscle pain was not recovered; of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,UNK,SYNTHROID,,Medical History/Concurrent Conditions: Thyroid disorder,,,"['Arthralgia', 'Asthenia', 'Back pain', 'Chills', 'Fatigue', 'Feeling cold', 'Head injury', 'Headache', 'Loss of consciousness', 'Myalgia', 'Nausea', 'Pain in extremity', 'Sleep disorder', 'Vaccination site pain']",1,PFIZER\BIONTECH, 934925,,,U,"Fainting; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of 2 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fainting on an unspecified date with outcome of unknown. The action taken in response to the event for bnt162b2 was not applicable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006219 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Syncope'],UNK,PFIZER\BIONTECH, 934927,MI,40.0,F,"Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,,,Medical History/Concurrent Conditions: COVID-19 (if covid prior vaccination: YES); Latex allergy,,,"['Arthralgia', 'Chills', 'Confusional state', 'Feeling abnormal', 'Hallucination, auditory', 'Hallucination, visual', 'Headache', 'Insomnia', 'Neck pain', 'Panic reaction', 'Paraesthesia', 'Pyrexia', 'Skin burning sensation', 'Tachycardia', 'Vomiting']",1,PFIZER\BIONTECH, 934928,MI,,F,"Immunocompromised; This is a spontaneous report from a Pfizer-sponsored program, received via a contactable consumer. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13,Solution for injection in pre-filled syringe, lot number/expiration date unknown) via an unspecified route of administration on 08Nov2020 at a single dose for immunization. Medical history included Crohn's. Concomitant medications included infliximab (INFLECTRA) for Crohn's. The patient was told by her doctor she should get a dose of Pneumovax 23 vaccine in 8 weeks due to her being immunocompromised. However, the pharmacist told her that she should wait for one year. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,11/08/2020,,,UNK,INFLECTRA [INFLIXIMAB],,Medical History/Concurrent Conditions: Crohn's,,,['Immunodeficiency'],UNK,PFIZER\WYETH, 934929,VA,34.0,F,"rash; All over rash with some itching; This is a spontaneous report from a contactable Nurse reported for self. This 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan 2021 12:50 on right arm at single dose (Lot # EK4176, Expiration Date: Mar2021) for covid-19 immunisation. Medical history was not provided. Concomitant medications were none. Past drug history included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Dec2020 16:00 at age of 34 year old at single dose (Lot # EH9899) for covid-19 immunisation. About 30 minutes after being administered (05Jan2021 13:20) that second dose she developed all over rash with some itching. She took Benadryl and Pepcid in response. Today the all over rash with some itching came back at the same persistent level. She wants to know what kind of timeframe she can expect with the continued allergic reaction of all over rash with some itching. She was made to check into the emergency room for observation, but did not have any testing/lab work/investigations done and was not admitted to the hospital. Outcome of the events was not recovered. Reporter seriousness for All over rash with some itching was Medically significant. Drug result was related.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Rash and Itching cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Hypersensitivity', 'Pruritus', 'Rash']",UNK,PFIZER\BIONTECH, 934931,AZ,45.0,F,"Chills with no fever; Cramping in legs; super tired with no energy; Body aches; tiredness/Feeling super tired with no energy; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for self that the 45-year-old female patient who receive first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on Saturday (02Jan2021) at single dose (once by injection in the right arm) for covid-19 immunisation. Medical history included ongoing Hypothyroidism from 2008. Concomitant medications included levothyroxine at 75 ug ongoing from 2008 for Hypothyroidism. Medical Professional and told by her work that she could get it because contact with COVID patients. The consumer calls for information about if the side effects she is experiencing after the administration of the COVID-19 vaccine will last for more days. The consumer reported tiredness and other side effects to DSU. A Consumer calls for information about if it would be appropriate the second dose of the COVID-19 vaccine is not administered considering that she had adverse reactions. Consumer calls for information about if the second dose of the COVID-19 vaccine would cause her more side effects than the first one. Received the vaccine on Saturday, 02Jan2021. The day she got it she did not feel anything at all. She was completely fine. She did not even have pain at the injection site. The next day, on Sunday she started feeling super tired with no energy, had body aches, and cramping in legs from 03Jan2021. She has had these for the past 3 days now. She also had chills with no fever from 03Jan2021 to 05Jan2021. She took Tylenol for the first 2 days, but it did not help her at all. She is feeling a little better today, but not much. Her question is, how long will these side effects last? Tylenol: She says it did help a little bit. She think she would just sleep because she was uncomfortable. The Tylenol just did not make her symptoms go away completely. LOT/Batch: AA46487, EXP: Apr2022 UPC: The consumer says the number under the barcode is: 5187536. Feeling super tired and body aches: Has improved about 20%. She says these are all medically significant as she is not able to do what she was able to do before getting the vaccine. She is super tired with no energy and she is confined to her bed most of the time. The consumer confirms this is her first dose of the COVID Vaccine. She thinks she got the standard dose. Vaccine card does not have the expiration date or NDC written on it. Unknown causality. She said that she could be positive for COVID. She is unsure. The outcome of the event Chills with no fever was recovered. The outcome of the event Cramping in legs was not recovered. The outcome of the other events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,UNK,,Hypothyroidism (Patient Medical comments; Verbatim: Hypothyroidism),,,,"['Asthenia', 'Bedridden', 'Chills', 'Discomfort', 'Fatigue', 'Loss of personal independence in daily activities', 'Muscle spasms', 'Pain']",1,PFIZER\BIONTECH, 934934,FL,36.0,F,"I was in a low disease state of SLE, 2 days after injection i had a severe flare of lupus requiring steroids; This is a spontaneous report from a contactable other Hcp (patient). This 36-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EH9899), intramuscularly on 16Dec2020 13:30 at single dose in Arm left for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included systemic lupus erythematosus (SLE) and in remission. No Pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.Concomitant medication received within 2 weeks of vaccination included hydroxychloroquine, topiramate (TROKENDI), prucalopride succinate (MOTEGRITY). The patient was in a low disease state of SLE, 2 days after injection and had a severe flare of lupus requiring steroids on 18Dec2020. The adverse event result in Doctor or other healthcare professional office/clinic visit. Steroids received as treatment. The outcome was recovering. The events were assessed as non-serious; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Systemic lupus erythematosus syndrome aggravated cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/18/2020,2.0,PVT,; TROKENDI; MOTEGRITY,,Medical History/Concurrent Conditions: SLE (was in remission),,,"['Condition aggravated', 'Systemic lupus erythematosus']",1,PFIZER\BIONTECH,OT 934936,IL,30.0,F,"experiencing an allergic reaction; Hives all over her face and neck/hives on face and neck; This is a spontaneous report from a contactable Physician (patient). A 30-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140, Expiry Date: 31Mar2021) via an unspecified route of administration in left upper arm on 31Dec2020 13:25 at single dose for COVID-19 immunisation. Medical history included crohn's disease from Jul2005 and ongoing, ongoing psoriasis, gastrooesophageal reflux disease (GERD), hand tremor. Concomitant medication included ongoing infliximab (REMICADE) for Crohn's, ongoing esomeprazole sodium (NEXIUM) for GERD, ongoing propranolol for hand tremor, copatsol topical steroid for Psoriasis, ongoing Multivitamin, ongoing vitamin B complex (B COMPLEX), ongoing biotin, ongoing iron, ongoing Calcium/Vitamin D, ongoing curcuma longa (TURMERIC). The patient had an allergic reaction after getting the COVID vaccine. She had an allergic reaction after getting the vaccine. She had hives all over her face and neck. She already had a Medrol Dose Pack at home and some Benadryl. She contacted her doctor who prescribed an Epi Pen for her, but she did not have to use the Epi Pen. She stated she used the Benadryl for three days. She started to get hives all over her face and neck the same date she got the vaccine. It started 2 hours after she got the vaccine (31Dec2020 15:25). She confirmed this was the first dose of the COVID Vaccine. She asked that if it is safe to take the second dose after experiencing an allergic reaction to the first dose. Symptoms include hives on face and neck. Patient had no trouble breathing. Took steroids and Benadryl for 3 days or until symptoms have been managed. No any of the events require a visit to emergency room. Reporter seriousness for hives all over her face and neck was reported as medically significant. Events outcome was recovered on 03Jan2021.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Allergic reaction and Hives cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PHM,REMICADE; NEXIUM [ESOMEPRAZOLE SODIUM]; PROPANOLOL [PROPRANOLOL]; B COMPLEX [VITAMIN B COMPLEX]; ; ; ; TURMERIC [CURCUMA LONGA]; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYR,Crohn's disease; Psoriasis,Medical History/Concurrent Conditions: GERD; Tremor of hands,,,"['Hypersensitivity', 'Urticaria']",1,PFIZER\BIONTECH, 934937,NM,64.0,F,"blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot; sore left arm; This is a spontaneous report from a contactable nurse for herself. This 64-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 18Dec2020 at single dose on left upper arm (lot: EKS730), via an unspecified route of administration on 05Jan2021 14:30 at single dose (lot: EL1284 or EKI284) for COVID-19 immunisation. Medical history and concomitant medications were none. The patient did not have anything with the first shot except a sore left arm on 18Dec2020. She stated that if she lays on left side it is sore. The patient had the sore left arm both times that she got the vaccine. She got second dose of vaccine on 05Jan2021 at 2:30pm and had a blasting headache and just had chills that went away about hour ago on 05Jan2021. She did not have a fever but her skin felt hot on 05Jan2021. She stated that she had dry heaves on 05Jan2021. The patient started that she had a blasting headache within a few hours of the vaccine and it gradually got worst by the time she went to bed. Stated that the chills and dry heaves started then and throughout the night. The chills stopped an hour before she got up. Stated that she went to check her temperature and did not have a fever despite having chills and her skin feeling hot. Stated that nausea started about 10 at night on 05Jan2021. Seriousness for blasting headache, chills and dry heaves was disabling, for nausea was medically significant, for other events was non-serious. The patient took Ibuprofen for the headache. Stated that she was going to try to drink something. The outcome of sore left arm was not recovered; of chills was recovered on 06Jan2021. The outcome of other events was recovering. The causality for blasting headache, chills, dry heaves, nausea and skin felt hot was related (Source of assessment: Primary Source Reporter, Method of assessment: Agency Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the headache, chills, dry heaves and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/18/2020,12/18/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Headache', 'Nausea', 'Pain in extremity', 'Retching', 'Skin warm']",1,PFIZER\BIONTECH,OT 934939,MI,53.0,F,"severe muscle pain, diagnosis of polymyalgia rheumatica; This is a spontaneous report from a contactable other HCP (patient). A 53-year-old female patient received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), at the age of 53-year-old, via an unspecified route of administration at right arm on 18Dec2020 08:30 at single dose for covid-19 immunization. Medical history included hypertension (htn), allergies: penicillin. Concomitant medication included cefatrizine propyleneglycolate (CEFTIN), lisinopril, levothyroxine sodium (SYNTHROID). The patient experienced severe muscle pain, diagnosis of polymyalgia rheumatica on an unspecified date. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included COVID test rapid (Nasal Swab): negative on 06Jan2021. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect drug BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,,,PVT,CEFTIN [CEFATRIZINE PROPYLENEGLYCOLATE]; ; SYNTHROID,,Medical History/Concurrent Conditions: Hypertension; Penicillin allergy,,,"['Myalgia', 'Polymyalgia rheumatica', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 934940,TX,62.0,F,"shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever for 4 days, horrible chills that were just debilitating; ached everywhere/ severe aches; site soreness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration at left upper arm on 18Dec2020 at single dose for COVID-19 immunization. Medical history included auto immune problems, diabetes, thyroid condition, all ongoing since age 28; pemphigusvulgarism since Sep2020 and ongoing. No concomitant medications. Patient is a frontline worker. She received the vaccine on 18Dec2020 at (Name) where she works. 9 days later she got very ill. she didn't know if it's unrelated. She wanted to know if there is anything she need to be watching out for in order to get her second vaccine on Friday. She was so sick and she did have some autoimmune problems. She was really healthy. On 26Dec2020, she had a 103 degree fever for 4 days, horrible chills that were just debilitating. She was just shaking. She ached everywhere, she had severe aches since 26Dec2020. She got tested for Covid and it was negative on 28Dec2020, she had no cough and no vomit. She stayed in bed and drank lots of fluids and toughed it out. By New Year's Day (reported as 30Dec2020) her fever broke but she was so weak and didn't work. She was back at work now. Also, she experienced site soreness from the injection since 19Dec2020. She did have a cough or any shortness of breath. She felt awful. She had recovered. She was just a little nervous because everything she read said the reaction was more severe with second injection. She planned on getting the second shot. She would have a repeat Covid test on 07Jan2020. Reporter seriousness for fever 103: Medically significant. Reporter seriousness for severe aches: Medically significant. Reporter considered the causality of the event site soreness was related with bnt162b2, of the events fever 103 and severe aches was unknown. The outcome of the event fever was recovered on 30Dec2020, of event ache was recovered on 31Dec2020, of event chills was recovering, of event vaccination site pain was recovered on an unspecified date in Dec2020, of events cough and shortness of breath was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever, pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/19/2020,1.0,UNK,,Autoimmune disorder (since age 28); Diabetes (since age 28); Pemphigus vulgaris; Thyroid disorder (since age 28),,,,"['Asthenia', 'Chills', 'Cough', 'Dyspnoea', 'Feeling abnormal', 'Illness', 'Impaired work ability', 'Injection site pain', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tremor']",UNK,PFIZER\BIONTECH, 934942,FL,,M,"(doctor) was not sure whether or not he might get a staph infection, a viral infection; (doctor) was not sure whether or not he might get a staph infection, a viral infection; thought he had a mosquito bite; area on the opposite side of his body, on the left hand side, he noticed that there were several small pustules; the area was raised, it was red, it was warm; Pain; extremely uncomfortable; It was very, very itchy and the area felt like it got itself swollen; It was very, very itchy and the area felt like it got itself swollen; irritation; Initially an area under his left arm which was very swollen it appeared to be filled with fluid of some type/thought it was edema/now had it under his right arm, it's probably impacting lymph system; This is a spontaneous report from a contactable consumer (patient wife). A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899, expiration date not reported), via an unspecified route of administration on 03Jan2020 16:00, at a single dose for Covid-19 immunization. Medical history included heart bypass 15 years ago and some orthopedic problems. The patient's concomitant medications were not reported. The patient previously took codeine and epinephrine experienced sensitivity. On 03Jan2020, the patient had an injection the Pfizer vaccine in county (not clarified further) (place name withheld) which is the (place name withheld) area on Sunday at approximately 4:00 PM EST. He has no significant medical problems other than the prior history of, he had heart bypass 15 years ago and some orthopedic problems, but nothing else other than that. She had never had any adverse reactions to any medications although he has, he shouldn't say, he does have a sensitivity to Codeine which he reported and Epinephrine which he had a sensitivity to also. He got the vaccine after waiting three and half hours in line and they went off, last night that would be Sunday night, several hours later he noticed an odd sensation and did not really take a look at it, he thought he had a mosquito bite perhaps as they live in (place name withheld) and they live in the land that has lots of mosquito, so he didn't pay too much attention to it. Approximately four hours after the injection, he was going to go to bed and removed his shirt and found that the area on the opposite side of his body, on the left hand side he noticed that there were several small pustules, the area was raised it was red it was warm, it was on the opposite side under his arm on his chest he was extremely uncomfortable. It was very, very itchy and the area felt like it got itself swollen and he shared with his wife, the wife suggested that he contact the physician of course he didn't contact, his primary physician said he can see a dermatologist and sent images and yesterday he went to see a dermatologist, so prophylactically he took the 25 mg of diphenhydramine hydrochloride (BENADRYL) and also 2 acetaminophen (EXTRA STRENGTH TYLENOL) and he treated the pain and itching with ice. He slept with an ice bag and woke up just in morning and in New Year they were able to see a dermatologist, he thought it was dermatological. He was concerned but not overly concerned with the area pretty swollen. He saw a dermatologist yesterday, and gave him a topical treatment, the dermatologist gave him three different, naproxene (NAPROSYN), the other one is Triamcinolone Acetonide cream now the irritation he got the MUPIROCIN ointment now as the dermatoligist told him to do, continue what he was doing as he was comfortable, The dermatologist took some specimens from the pustules and send them to lab and she (doctor) is not sure whether or not he might get a staph infection, a viral infection he was not sure. Initially there was an area under his left arm which is very swollen it appeared to be filled with fluid of some type, he was not sure what was it. He thought it was edema but when he popped it, it felt very much like fluid not like blood but it is some type of fluid filled area most likely his wife said the size are greater and less that it was yesterday and that seems to go down over the last night but not all the way it's decreased by what 20%, 30%, 40% he can't tell, alright 50% but now he has it under under right arm, it's probably impacting his lymph system and he put a call into his cardiologist. So he was asking now what does he do. The outcome of the events were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2020,01/03/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Bypass surgery (heart bypass 15 years ago); Orthopaedic disuse,,,"['Discomfort', 'Erythema', 'Paraesthesia', 'Pruritus', 'Pustule', 'Skin culture', 'Skin warm', 'Swelling']",UNK,PFIZER\BIONTECH, 934943,MO,75.0,F,"Her arm is a little sore; the tissue paper is red after wiping her anal area/ reddish looking poop/ there are pieces of blood or something is different; This is a spontaneous report from a contactable other Health Professional (patient). A 75-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization, also reported as for work. Medical history included ulcer (15 to 20 years before 06Jan2021). Concomitant medication included prasugrel from Apr2020 and ongoing as blood thinner, acetylsalicylic acid, ascorbic acid (ASPIRIN) from Apr2020 and ongoing as blood thinner. The patient went to the bathroom in the morning 06Jan2021, she had to poop. When she wiped, it was reddish looking. The patient stated her stool color was normal, but the tissue paper is red after wiping her anal area. At first she thought hm oh well. Then she had been to the bathroom a couple of times 06Jan2021, and that the same thing happened. She had never experienced that before. It seems to her that there were pieces of blood or something was different. She wasn't hurting or anything. She was not weak or anything at this time. Her arm was a little sore, but she expected that. She was concerned about the color. She worked in the mammography department. She didn't have a prescribing doctor. She got it at work. She had noticed a difference of color in her poop. It had been the same all day. The outcome of the reddish poop was not recovered, of sore arm was unknown. The patient asked would the vaccine cause rectal blood upon wiping after defecation?; Sender's Comments: Reported blood in stool is considered intercurrent and unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,UNK,; ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID],,Medical History/Concurrent Conditions: Ulcer,,,"['Faeces discoloured', 'Pain in extremity', 'Rectal haemorrhage']",UNK,PFIZER\BIONTECH, 934944,CA,50.0,M,"The subject experienced acute pericarditis on 27Dec2020; Other vaccine same date vaccine date= 23Dec2020; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The facility type vaccine was hospital. None medical history. The patient's concomitant medications were not reported. Other vaccine same date vaccine date on 23Dec2020. The patient experienced acute pericarditis on 27dec2020 with outcome of recovered. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. It's unknown if treatment was received for the adverse event. The event was reported as non-serious. Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Pericarditis'],UNK,PFIZER\BIONTECH, 934946,IN,70.0,F,"Joint pain /felt like it was worsening joint pain; just severe pain to where she couldn't walk; This is a spontaneous report from a contactable Other HCP. A 70-year-old female patient received BNT162B2(Lot Number: ET1685), via an unspecified route of administration at Deltoid Left on 23Dec2020 08:00 at the 70 years old at single dose for COVID-19 immunization. The medical history included rheumatoid arthritis. The concomitant medications were none. The patient received the shot on 23Dec2020 and experienced Joint pain afterward on 02Jan2021. The patient did have rheumatoid arthritis so there was that. The patient felt like it was worsening joint pain on 02Jan2021. She has had no fever, just severe pain to where she couldn't walk on 02Jan2021. The joint pain has gotten worse and it has gotten to where she is going to advise her not to take the second shot. The Reporter assessed the seriousness for the events was Disabling. The events did not require a visit to Emergency Room but required a Physician Office visit on 06Jan2021. The patient received a steroid injection on 06Jan2021. There was none History of all previous immunization with the Pfizer vaccine considered as suspect. There was none Additional Vaccines Administered on Same Date of the Pfizer Suspect. There was no Prior Vaccinations within 4 weeks. The patient underwent lab tests and procedures, which included x-rays on 06Jan2021: unknown results (they were awaiting the X-rays). The outcome of the events was not recovered. The information on the batch number has been requested.; Sender's Comments: Based on the available information the events worsening joint pain and walking difficulty are attributed to underlying Rheumatoid arthritis; however, based on a compatible temporal association, contributory role of BNT162B2 vaccine to events occurrence cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/23/2020,01/02/2021,10.0,UNK,,,Medical History/Concurrent Conditions: Rheumatoid arthritis,,,"['Arthralgia', 'Condition aggravated', 'Gait inability', 'Pain', 'X-ray']",UNK,PFIZER\BIONTECH, 934947,NY,31.0,F,"it was debilitating for her at work; It even hurts to move the right eye in one direction and hurts to speak, the pain was so bad.; pain in right leg and bottom sole of right foot; hurts to speak; numbness right upper side of lip; pins and needle feeling right upper quadrant of face; pain and dull aching right upper side of face; right hand numbness, wasn't able to feel anything; generalized headache; generalized muscle weakness and pain; generalized muscle weakness and pain; This is a spontaneous report from a contactable other hcp (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 at single dose in deltoid right for covid-19 immunization. There were no medical history or concomitant medications. The patient received the vaccine on 03Jan2021 and within 15 minutes had a generalized headache. Later that night she had generalized muscle weakness and pain, but really didn't think too much about it. The next day at work (04Jan2021), she had numbness on the right upper side of her lip and a pins and needle feeling in the right upper quadrant of the face. Had a lot of pain in the area as well on the right upper side of the face as well as a dull aching pain that lasted for hours. Later that day when using the computer and she was trying to reach for her mouse she noticed her right hand wasn't able to feel anything and that lasted about 20-25 minutes. Kept slapping the mouse with her hand, but could not feel anything, her hand went numb. Yesterday (05Jan2021), she had the same pins and needle feeling in the same area of the face and that dull achy feeling and it occurred for hours and it was very kind of debilitating for her at work. Later that night she had pain in her right leg and felt the same way, that very severe achiness, which was the pins and needles feeling up and down the leg and underneath the right foot. All these symptoms tend to be on her right side and it definitely lasted for hours. It started about 1 and didn't end until 6-7pm. It even hurts to move the right eye in one direction and hurts to speak, the pain was so bad. This morning (06Jan2021) she had to call out of work because at 3am the generalized headache, pain was unbearable. She was still experiencing the pain in right leg and bottom sole of right foot. She did not receive any vaccines the same day or 4 weeks prior. No problems with vaccines in past. She had made an appointment with a neurologist and will have a MRI done on Friday, 08Jan2021. No further details provided. All events required a visit to physician office. All events were reported as serious per medically significant. The outcome of all events was not resolved. The reporter considered all events were related to the vaccine. Information about Lot/Batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Eye pain', 'Facial pain', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Impaired work ability', 'Muscular weakness', 'Myalgia', 'Pain', 'Pain in extremity', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 934949,NC,43.0,F,"soreness/The pain radiates down to her left elbow and also goes up the neck; The pain radiates down to her left elbow and also goes up the neck; The pain radiates down to her left elbow and also goes up the neck; This is a spontaneous report from contactable other HCP (patient' husband). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. No concomitant medications. The patient had a whole lot of soreness on 01Jan2021 and it was not getting any better. His wife had called her health care provider. She had an appointment in several days. The pain radiates down to her left elbow and also goes up the neck in Jan2021. The reporter seriousness for soreness: Medically significant. The outcome of event pain was not recovered. The outcome of rest events was unknown.; Sender's Comments: Based on a compatible temporal relationship, causality between event pain and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No",,,"['Arthralgia', 'Neck pain', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 934950,TX,59.0,F,"She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened; From the time she got the vaccine to now, she has lost 20 lbs; shake/shaking; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; She has been sick since Wednesday; itching all over from head to toe; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 30Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension and allergic to ace inhibitors. There were no concomitant medications. Patient was calling about the Covid Vaccine. She was having an allergic reaction. She did not know what to do to stop it. She went to the ER yesterday (04Jan2021). She had been sick since Wednesday (30Dec2020), she was itching all over from head to toe since 30Dec2020, she got a prescription for Prednisone, she took 2 doses yesterday, 1 dose today, and would take another this evening. She took Benadryl, an hour ago and had an episode, and so she had to jump in the shower and let the cold water run to stop itching, the itching did not stop but it has minimized. She put Benadryl gel and she was still itching, she had taken enough Benadryl. Patient asked what is the best way and if she needed an IV of something, she went to ER on Sunday, she was not seen by doctor, it was a nurse practitioner, she didn't do anything but just listen to her and she only looked at ankles to check for swelling. Patient stated that she had been drinking water and urinating, she had no appetite and lost 20 lbs. Patient confirmed that she got her first dose of the Covid vaccine on 30Dec2020 at 1 o clock, the itching started the same day at 5 o clock, the itching was from head to toe. She experienced swelling in the lips, throat, and eye lids, which started 02Jan2021. She began losing her appetite on 30Dec2020. From the time she got the vaccine to now (05Jan2021), she has lost 20 lbs. An hour ago (05Jan2020) she had an episode, which made her shake, and she did not have the shakes before, this was the first date she started shaking. Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened. Her 2nd dose was scheduled in 21 Days. However, she may not get the second dose, patient stated that she could not get through this no more. She had no positive test for Covid prior to vaccine. She had no antibody test prior to the vaccine. She had not any issues with vaccines in the past. Patient stated that if she was still feeling this way, she would go to a different hospital. When she went to the ER, she was not hospitalized, they sent her back home the same day. Patient would like to know if there was anything that can remove the vaccine from the body. The outcome of the events itching all over from head to toe, loss of appetite, swelling in the lips, throat, and eye lids was not recovered, of the other events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Hypertension; Specific allergy (drug),,,"['Decreased appetite', 'Hypersensitivity', 'Lip swelling', 'Malaise', 'Pharyngeal swelling', 'Pruritus', 'Swelling of eyelid', 'Tremor', 'Weight decreased']",1,PFIZER\BIONTECH, 934951,AZ,35.0,M,"Acute demyelinating encephalomyelitis; Slurring his speech; Stroke; This is a spontaneous report from a contactable physician. A 35-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in deltoid (unknown if right or left) on 17Dec2020 at 30 ug, single for 'Preventative'. Medical history included hypertension. There were no concomitant medications.(Physician) He is calling about the Pfizer Covid 19 vaccine. States what is going on with the patient may be associated as a side effect. The patient got the vaccine two to three weeks ago, he clarifies the patient received the vaccine on 17Dec2020 and the patient ended up acutely developing (states it is a presumptive diagnosis) Acute demyelinating encephalomyelitis, states it looks like a radiologic diagnosis. The patient is an employee at hospital. When querying seriousness states it is medically significant but could be disabling but he thinks the patient will recover. Reporter seriousness for acute demyelinating encephalomyelitis: Medically significant, Hospitalization. Patient was hospitalized on Sunday and he is still admitted at this time. Dates when patient was in hospital for acute demyelinating encephalomyelitis was from 03Jan2021 to ongoing. Caller thinks the patient was flown to (Place) yesterday. The patient's mother asked the caller if the caller thought the acute demyelinating encephalomyelitis was from the vaccine and the caller responded that he did not think it was from the vaccine. He confirms the patient is still admitted in the hospital and the patient's attending neurologist is doctor. The caller heard about the patient from doctor. When querying covid vaccine dose, the caller states the standard dose is 30 mcg. This was clarified and documented as provided. The patient has not received his second dose yet. He asks if the patient should receive the second dose. He asks a general question if a pregnant patient can be given the Pfizer covid vaccine. He heard the patient had a stroke then the CFO tried to talk to him and the patient was slurring his speech. Caller spoke to the patient's mother this morning and caller told the mother that he would try to find out what is going on with the patient. He asked that the patient get an HIV test even though he does not think the patient is at risk. Vaccination facility type was Hospital. Vaccine administered at military facility was No. None additional vaccines administered on same date of the PFIZER suspect. AE acute demyelinating encephalomyelitis require a visit to Emergency Room, not visit to physician office. Prior Vaccinations (within 4 weeks) was none. He has heard of acute demyelinating encephalomyelitis being associated with vaccines in the past and states that it is rare and usually in kids. States he saw patients that may have had acute demyelinating encephalomyelitis back in the 80s and 90s. Therapeutic measures were taken as a result of acute demyelinating encephalomyelitis (Patient will get steroids tonight pending the review of the x-ray). The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported stroke with speech slurred, and the presumptive diagnosis of acute demyelinating encephalomyelitis (looks like a radiologic diagnosis by the reporting physician), was most likely an intercurrent disease, and unlikely causally related to the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,12/17/2020,,,PVT,,,Medical History/Concurrent Conditions: Hypertension,,,"['Acute disseminated encephalomyelitis', 'Cerebrovascular accident', 'Diagnostic procedure', 'Dysarthria', 'HIV test', 'X-ray']",1,PFIZER\BIONTECH,OT 934953,,49.0,F,"her nerve was bad; Getting all sick, cold, sick and experiencing terrible side effects; Getting all sick, cold, sick and experiencing terrible side effects; Fatigue; Muscle ache; Nauseous; Felt awful; Can't eat all the day, no appetite; phobic something to drinking water; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (lot/batch number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. No relevant medical history. The patient's concomitant medications were not reported. The patient experienced getting all sick, cold, sick and experiencing terrible side effects, fatigue, muscle ache, nauseous, cannot do anything, felt awful, cannot eat all the day, no appetite, phobic something to drinking water. The patient has been sick for three days now. The patient was a ""senior"" (not clarified) care giver at the nursing home. Everybody at nursing home at the nursing home got the shot and now everybody has cold and sick. She has only one day of work and she has to come into her job to take care of elderly people. As since current everybody is experiencing the terrible adverse, terrible side effects, everything. Fatigue, muscle ache everything. The bosses at her nursing home cannot give them three days or even seven days off of work after receiving a contract to give them shot. It was confirmed that the patient received the COVID vaccine. The patient also stated that they are off of that side effects. They are not interrupted not just the ""arm"" (not clarified) been there. The patient said she getting everything. She was getting all the side effects. So when they had this Pfizer drug shot ""they didn't get seven days off of"" (not clarified) work. If a person gets a shot, they are feeling fatigue, nauseous (incomprehensible voice). They can't do anything. They should be allowed to stay home from work. Right now everybody in the nursing home is feeling the adverse effect. The entire building. So, she was telling Pfizer to report the report is that all of sudden that the nursing home ""seniors"" (not clarified) and nurses they got the shot, they can't even get to work. The effects are so bad that they can't do anything. The patient also stated that fatigue, she had fatigue all day. The first day she got the shot her nerve was bad but the second day was everything fatigue. She felt awful, she could not eat, she had no appetite. She was phobic something to drinking water, she cannot eat all the day. ""Fruit or something 5 I can eat"" (incomprehensible voice)."" When probed for the LOT#, the reporter stated, ""No they did not give me anything. All they did is I think 037 I think it looks like a 'K' 20A. (further not clarified) like it says (further not clarified) 037K20A that's (further not clarified)."" The outcome of the events was unknown. Information on lot number/batch number was requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Decreased appetite', 'Fatigue', 'Feeding disorder', 'Feeling abnormal', 'Feeling cold', 'Loss of personal independence in daily activities', 'Malaise', 'Myalgia', 'Nausea', 'Nervousness', 'Phobia', 'Speech disorder']",UNK,PFIZER\BIONTECH, 934954,,,U,"aware of 6 cases of Bell's Palsy by the companies making these vaccines; This is a spontaneous report from contactable Other HCP. This Other HCP reported same events for 6 patients. This report is for 2nd of 6 patients. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The other HCP was aware of 6 cases of Bell's Palsy by the companies making these vaccines since an unknown date. The event was reported as non-serious. The event outcome was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between event Bell's Palsy and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021007605 same reporter, same drug, same event, different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Facial paralysis'],UNK,PFIZER\BIONTECH, 934955,,,U,"aware of 6 cases of Bell's Palsy by the companies making these vaccines; This is a spontaneous report from a contactable other HCP. This Other HCP reported similar events for 6 patients. This report is for 3rd of 6 patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter reported since the use of modified RNA in covid vaccines, he/she had aware of 6 cases of Bell's Palsy by the companies making these vaccines since an unknown date. The outcome of the event was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between event Bell's Palsy and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021007605 Different patient, same drug/event.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Facial paralysis'],UNK,PFIZER\BIONTECH, 934957,,,U,"aware of 6 cases of Bell's Palsy by the companies making these vaccines; This is Spontaneous report from a contactable Other HCP. This Other HCP reported similar events for 6 patients. This is 4th of six reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter reported since the use of modified RNA in covid vaccines, he/she had aware of 6 cases of Bell's Palsy by the companies making these vaccines since an unknown date. The outcome of the event was unknown. Information on the Lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between event Bell's Palsy and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021007605 same reporter, same drug, same event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Facial paralysis'],UNK,PFIZER\BIONTECH, 934958,,,U,"aware of 6 cases of Bell's Palsy by the companies making these vaccines; This is a spontaneous report from a contactable other health professional (HCP). This other HCP reported similar events for 6 patients. This is the 5th of 6 patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter reported since the use of modified RNA in covid vaccines, he/she had aware of 6 cases of Bell's Palsy by the companies making these vaccines since an unknown date. The outcome of the event was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021007605 Different patient, same drug/event.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Facial paralysis'],UNK,PFIZER\BIONTECH, 934959,CT,60.0,F,"Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache/ So much pain in my head; Couldn't talk; Complete brain fog; nausea; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (Patient) reported that received bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included Atrial fibrillation, Chronic Lyme, Lupus and Autoimmune. Concomitant medications included Metoprolol at 12.5 mg for Atrial fibrillation and acetylsalicylic acid (BABY ASPIRIN). No diabetes, no hypertension. None of the usual common diseases. Registered Nurse stated, ""I received vaccine this past Wednesday. I was just talking to a couple of my colleagues and honestly I received the vac. at work. I did not really read through the paperwork and was 'weird' sharing reactions to the vaccine which for me was pretty bad reaction and thought like I need to go through your paperwork and report it. So I thought I should call and just give some information. The usual fatigue which I go to after being normal, my arm was not sore. However, as the week progressed into Friday I had a constant headache but it was manageable and then by Friday night my glands swelled, my nerves behind my ears, my neck and I was extremely fatigued, bad headache and went to bed and I had not gone out and finally I got out today I spoke with my Physician yesterday. What happened it looked like an encephalopathy but my head swelled, my face was all swollen, complete brain fog, fatigue and I couldn't talk. I was in so much pain in my head resulting in (incomplete sentence)."" Lab work included the only thing is the PCR swabbing. No blood test. Registered Nurse further stated, ""I don't know if that is important. But I will tell you and if it is you can send me the questions. I do have a history of Autoimmune. So my Physician thought that this was just like an enhancement of like my bodies reaction I have Chronic Lyme and I have lupus like my ANA has always been stressful. But we think that it is a family thing. No treatment for the Lyme. I did a lot of antibiotic and a lot of naturopathic stuff but that is in the past. But anyhow for anything else what I did was when I got the injection they said try and just take Tylenol not Ibuprofen but there was no way I was going to make it through with just that . So I took Ibuprofen. I called my Physician yesterday morning because I was not sure about what was is happening and I thought it might be secondary sinus infection or something else going on and it reassured me that it is definitely due to the vaccine. He said it is just your body's reaction, take the Ibuprofen, hydrate. Had me take what I had in my house Tigan for nausea. So I was extremely nauseous from the severity of the headache."" Registered Nurse stated, ""I just wanted to let you know what happened and the intensity of what it was because normally I would expect a headache. But this was a 'go dated'. Registered Nurse stated, ""I guess the only question that I have is so do my work has this question and I was going to call my doctor tomorrow may be might know it better. I know that I have to take the second dose. But I understand the second round can be worse than the first. Is there anything that they are recommending that I can do may be prior to ease the reaction?"" The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported clinical manifestations including swelling face and head swelled, which was suspected as encephalopathy by the reporting nurse, was probably related to the bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), due to temporal relationship. The subject's underlying Chronic Lyme, Lupus and Autoimmune were likely the risk factors to the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,,,WRK,; BABY ASPIRIN,,Medical History/Concurrent Conditions: Atrial fibrillation (Verbatim: Atrial fibrillation); Autoimmune disorder (Autoimmune); Lupus syndrome (Verbatim: Lupus); Lyme disease (Verbatim: Chronic Lyme),,,"['Aphasia', 'Fatigue', 'Feeling abnormal', 'Head discomfort', 'Headache', 'Lymphadenopathy', 'Nausea', 'SARS-CoV-2 test', 'Swelling face']",UNK,PFIZER\BIONTECH, 934961,TX,35.0,F,"Swollen lymph nodes; blood pressure was 90/50; Chills; body aches; Fatigue; Joint pain; Bone pain; Headache; Swelling, pain, redness and soreness at the injection site; Swelling, pain, redness and soreness at the injection site; Swelling, pain, redness and soreness at the injection site; Tachycardia / heart rate was 144-152; painful to breath and she was grunting; also said that the injection site itched a little bit.; Fever; First dose on 17Dec2020, second does on 04Jan2021; This is a spontaneous report from a contactable nurse reporting for herself. A 35-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) ( (lot number was unknown) intramuscularly on 17Dec2020 at 0.3ml, and the second single dose (lot number EJ1685) intramuscularly on 04Jan2021 07:45 at 0.3ml, for COVID-19 prophylaxis. Medical history included ongoing diabetes. Her diabetes was diagnosed about 6 months ago (reported on 06Jan2021) and was well controlled. Her glucose was at 140 at the ER (emergency room) even after drinking a drink that had sugar in it. The patient's concomitant medications were not reported. The patient received the second dose on 04Jan2021 at 07:45 and experienced a severe reaction hours after she received it, and she ended up having to go the ER and that they were baffled about what happened. She reported her symptoms were: fatigue, joint pain mainly in her knees, bone pain that did not feel like muscle pain, headache, swollen lymph nodes in the left axilla, and swelling, redness, pain, and soreness in the left arm at the injection site and also said that the injection site itched a little bit. Her symptoms started about 9-10 at night on 04Jan2021. She said that she felt like with the second dose she noticed the soreness and pain and redness at injection site after about 2 hours after receiving the second dose, which was sooner than with the first injection. The fever started with the chills and body aches. The chills and body aches started at 22:00 on 04Jan2021. She took acetaminophen and melatonin to try and sleep it off. Fever was after that at around midnight 04Jan2021 and she was burning in fever and her temperature was 104. She stated she started taking layers off and got out from under her covers. She had a sweater on when she took her temperature and her axillary temperature was 105. She said that she got into a hot shower because that was the only thing that provided comfort to her chills. She had not had any chills in about the last 12 hours though (as reported on 06Jan2021). She said that the body aches were so severe that she just sat in her bed and cried. She had tachycardia and she was grunting in pain. She was rotating ibuprofen and acetaminophen and then her fever was not as high. She stated that if her fever came back it was lower each time, and if she did not take the medications though, the bone pain was excruciating. She said that with the bone pain it was like no-one can hold her hand or hug her. Fatigue started at around midnight 04Jan2021. Her headache was at midnight. She felt like she had a headband on and was radiating down the back of her neck. She noticed the lymph nodes were swollen after she went to the ER at around 07:00-08:00 05Jan2021. She was walking with pillow under her arm, and if she moved or lifted her arm it hurt. She went to the ER at 01:00 05Jan2021. Her blood pressure was 90/50, her heart rate was 144-152 at rest, temperature was 102.8, O2 saturation was 95-96. She said that it was painful to breath and she was grunting, but did not have any breathing issues. The nurse thought she was septic and notified the doctor. The nurse and the doctor did not think it was the vaccine and thought that she was COVID-19 positive. But after they tested her, she was negative for flu and COVID and they were baffled. They were unclear on what happened and did not think it was from the vaccine. They bolused her 1 liter of Normal Saline and gave her a dose of Fentanyl that minimally helped with the bone pain. She was also given 30mg of ketorolac (TORADOL) IV (intravenous) and that significantly improved her pain. She was there a total of 3 hours. She was admitted to the back area of the ER. She said that they drew labs and everything was within normal limits. Her CRP (C-reactive protein) was 30 and her lactate was at 1.5. She said that they told her that she was most likely having an immune response to the vaccine. Her heart rate and blood pressure came to a more normal range and everything returned to baseline. Her heart rate was 109. She was told to rotate paracetamol (TYLENOL) and ibuprofen for at least the next 24 hours and hydrate. The events fever, chills, fatigue, joint pain, bone pain, headache, swollen lymph nodes, and swelling, pain, redness and soreness at the injection site were serious due to hospitalization from 05Jan2021 to 05Jan2021. The patient was recovering from fever, chills, joint pain, headache, heart rate and blood pressure, not recovered from fatigue, bone pain, swollen lymph nodes and swelling, pain, redness and soreness at the injection site. The event swollen lymph nodes worsened. The outcome of ""injection site itched a little bit"" was unknown. The reporter considered the events fever, chills, fatigue, joint pain, bone pain, headache, swollen lymph nodes, and swelling, pain, redness and soreness at the injection site were all related to the vaccine; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia, chills, fatigue, pain, arthralgia, bone pain, headache, lymphadenopathy, vaccination site erythema, vaccination site swelling, vaccination site pain, blood pressure decreased, tachycardia, grunting and vaccination site pruritus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/04/2021,01/04/2021,0.0,UNK,,Diabetes (Verbatim: Diabetes),,,,"['Arthralgia', 'Blood glucose normal', 'Blood lactic acid decreased', 'Bone pain', 'Burning sensation', 'C-reactive protein increased', 'Chills', 'Crying', 'Fatigue', 'Grunting', 'Headache', 'Influenza virus test negative', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Lymphadenopathy', 'Pain', 'Painful respiration', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tachycardia', 'Tension headache', 'Vaccination complication']",2,PFIZER\BIONTECH,OT 934962,OH,58.0,F,"01-08-21 - headache; injection site sore 01-09-21 - headache; injection site sore 01-10-21 - headache; injection site sore 01-11-21 - headache; injection site sore, injection site redness; injection site warm to touch",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/11/2021,3.0,PVT,KEFLEX; NEXIUM; NOVOLOG; LANTUS; PRILOSEC,,"Syncope; Lymphocytic colitis; Type 2 diabetes mellitus with both eyes affected by mild nonproliferative retinopathy without macular edema, with long-term current use of insulin; Sensorineural hearing loss; Tinnitus; BPPV (benign paroxysmal positional vertigo)",,sulfa (sulfonamide antibiotics)- vomiting,"['Headache', 'Injection site erythema', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 934965,WV,64.0,F,"The lip starting ripping and the face started itching; The lip starting ripping and the face started itching; It started spreading from the ear to the neck, it started itching bad and getting hive in that area; having trouble in breathing because it was swelling up; having trouble in breathing because it was swelling up; The lip was swelled to red and then it started to going up the jaw; The lip was swelled to red and then it started to going up the jaw; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EJ1686, expiration date: Mar2021) via an unspecified route of administration on the arm right in Dec2020 at single dose for COVID-19 immunisation. Medical history included ongoing blood pressure high. Concomitant medication included lisinopril taken for blood pressure high. The patient had the BNT162B2 on Thursday morning (Dec2020) and Thursday evening the patient had a reaction to that, the lip was swelled to red and then it started to going up the jaw. So the next day it was in the jaw and in the lip and then the lip starting ripping and the face started itching and that's didn't go away and then yesterday it started spreading from the ear to the neck, it started itching bad and getting hive in that area. The patient went to the emergency room, consumer stated that she had nurse practitioner that called her on a steroid (treatment). The consumer stated, ""the thing she called her also in an Epi Pen in case she has started having trouble in breathing because it was swelling up. The patient didn't have to end up using that but she just has to use in case she has"". Treatment was received for the events. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,Blood pressure high,,,,"['Chapped lips', 'Erythema', 'Lip erythema', 'Lip swelling', 'Pruritus', 'Swelling face', 'Urticaria']",UNK,PFIZER\BIONTECH, 934966,CA,,F,"COVID-19; COVID-19; Pneumonia; respiratory failure; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Jan2021 for COVID-19 immunization. Medical history included Alzheimer's and others. No known allergies. Concomitant medications included unspecified medications. The reporter's mother in law was tested for COVID-19 at a nursing facility on 25Dec2020 and she was negative. On 02Jan2021, she received the first dose of Pfizer vaccine. On 04Jan2020, she developed a high fever, needed oxygen and was positive for COVID-19. Date of death was 04Jan2021. The cause of her death was listed as pneumonia, respiratory failure and COVID-19. No autopsy performed. No treatment received. No one knew if the vaccination contributed to her death. It was hard to know if her death was due to the administration of the vaccine or it exacerbated the COVID19 symptoms which led to her death. Since this was unknown, it could have been a possibility. The reporter wanted to give us this information because we might want to consider having high risk population, patients with underlying conditions, older population tested for COVID-19 prior to the vaccination, as this is not currently a recommendation or a requirement. All is very new and they are all learning so the reporter wanted to share this information with us. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There are medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was fatal. Information about Lot/Batch has been requested.; Sender's Comments: The association between the fatal event lack of effect (pneumonia, respiratory failure and COVID-19) with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and COVID-19",Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/04/2021,2.0,UNK,,,Medical History/Concurrent Conditions: Alzheimer's disease,,,"['COVID-19', 'Death', 'Pneumonia', 'Pyrexia', 'Respiratory failure', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 934968,CA,54.0,M,"he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless; not feeling well; ate a bit but not much; kind of pale; Agitated; Vomiting; trouble in breathing; This is a spontaneous report from a contactable consumer (brother of the patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 04Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes and high blood pressure. Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken for diabetes, glimepiride (MANUFACTURER UNKNOWN) taken for diabetes, lisinopril (MANUFACTURER UNKNOWN), and amlodipine (MANUFACTURER UNKNOWN). The patient experienced not feeling well, ate a bit but not much, kind of pale, vomiting, trouble in breathing, and agitated on 04Jan2021; body was hyper dried and restless on 05Jan2021; mind just seemed like it was racing on 06Jan2021; and not responsive and he passed away on 06Jan2021 at 10:15 (reported as: around 10:15 AM). The clinical course was reported as follows: The patient received the vaccine on 04Jan2021, after which he started not feeling well. He went right home and went to bed. He woke up and ate a bit but not much and then was kind of pale. The patient then started to vomit, which continued throughout the night. He was having trouble in breathing. Emergency services were called, and they took his vitals and said that everything was okay, but he was very agitated; reported as not like this prior to the vaccine. The patient was taken to urgent care where they gave him an unspecified steroid shot and unspecified medication for vomiting. The patient was told he was probably having a reaction to the vaccine, but he was just dried up. The patient continued to vomit throughout the day and then he was very agitated again and would fall asleep for may be 15-20 minutes. When the patient woke up, he was very restless (reported as: his body was just amped up and could not calm down). The patient calmed down just a little bit in the evening. When the patient was awoken at 6:00 AM in the morning, he was still agitated. The patient stated that he couldn't breathe, and his mind was racing. The patient's other brother went to him and he was not responsive, and he passed away on 06Jan2021 around 10:15 AM. It was reported that none of the symptoms occurred until the patient received the vaccine. Therapeutic measures were taken as a result of vomiting as aforementioned. The clinical outcome of all of the events was unknown; not responsive was not recovered, the patient died on 06Jan2021. The cause of death was unknown (reported as: not known by reporter). An autopsy was not performed. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: not responsive and he passed away",Yes,01/06/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,UNK,; ; ;,,Medical History/Concurrent Conditions: Blood pressure high; Diabetes,,,"['Agitation', 'Death', 'Decreased appetite', 'Dehydration', 'Dyspnoea', 'Malaise', 'Pallor', 'Restlessness', 'Tachyphrenia', 'Unresponsive to stimuli', 'Vaccination complication', 'Vomiting']",UNK,PFIZER\BIONTECH, 934969,,42.0,F,"Acute appendicitis; Severe acute abdominal pain; Chills; Fever; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (expiration date Mar2021, incomplete lot number L0140, not sure the first letter it is C or E), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. None medical history. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient experienced a little bit chills and fever she felt coming exactly on the 26th but she expected that and that was all fine but patient ended up in (Incomplete sentence). She went to work on 30th December and had some onset of severe acute abdominal pain and she ended up in an emergency appendectomy by 6 O'clock that evening. So she had an acute appendicitis and she did some research and it says that she can be listed in to the severe complications that the number in the vaccinated group was double back to the procedural group. The 26th it resided and patient felt better until the 30th when she have acute severe abdominal pain onset. She left work went for emergency room and she was in surgery within four hours. The outcome of events chills and fever was recovering, the other events was unknown. Because of the research that is on the website patient cannot help and think that it is related. Patient believed the relatedness of drug to events was related. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/26/2020,3.0,UNK,LEXAPRO,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Abdominal pain', 'Appendicectomy', 'Appendicitis', 'Chills', 'Pyrexia']",1,PFIZER\BIONTECH, 934973,TN,92.0,F,Resident experienced vomiting and edema of the lips. The M.D prescribed benadryl.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,SEN,,"Alzheimers, Dementia, CVA (Hx), diabetes, CAD, SARS-CO-V2",See Above,,Sulfa,"['Lip oedema', 'Vomiting']",1,MODERNA,IM 934982,MI,39.0,F,"Developed extensive bruising, swelling, pain, to left deltoid, upper arm and numbness and tingling in her left wrist extending to her left thumb and index finger Patient is a 39 y.o. female with a past medical history of asthma and obesity who presents for evaluation of Chief Complaint Patient presents with Arm pain Reaction to covid injection Patient has swelling and bruising at the site of her recent COVID-19 injection given 2 days prior. She has been icing the area taking Motrin without relief. She has pain with movement of the arm and it seem to be worsening. She notes some numbness and tingling in her left wrist extending to her left thumb and index finger. She has a prior history of carpal tunnel. Blood pressure is well controlled today. No fever, chest pain, palpitation, shortness of breath. Exercise tolerance is stable. Tolerating medications well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,SEN,None noted,None noted,None noted,,None,"['Hypoaesthesia', 'Injection site bruising', 'Injection site pain', 'Injection site swelling', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Ultrasound scan']",1,MODERNA,IM 934989,AZ,53.0,F,"(1) First vaccine - slight effects of Covid symptoms. (2) Second vaccine - Headache, slight fever (took tyenol) -Sat am - swollen tongue when I woke up. Took benydril, swelling went down. tongue bled - (brush teeth, scrap tongue) -Sun - semi swollen tongue, rash lower abdomin. R am front area by under arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,WRK,,,,Slight patches of rash in sensitive areas of body.,,"['Headache', 'Pyrexia', 'Rash', 'Swollen tongue', 'Tongue haemorrhage']",UNK,PFIZER\BIONTECH, 934990,OH,26.0,F,"26-year-old lady came in after she noticed she had bruises on her left hand after a CPR procedure at hospital. Patient was apparently in well health, she had received COVID-19 mRNA vaccine on January 7 at 3 PM, she has taken 2 pills with ibuprofen and tylenol for pain in right deltoid following vaccination. She was doing the CPR at 1:00 this afternoon, and she noticed that her left dorsum had some bruises. She took day off and went home and noticed that she also had bruises in both medial thighs, above the knee and some bruises in scalp. Patient presented to the Emergency Room 1/9/2021 ~6PM and platelet count was found to be 2x10^3/uL. Patient required transfusion of 7 units of platelets, steroids, and IVIG.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/07/2021,01/09/2021,2.0,PVT,Ibuprofen and acetaminophen,None,None,,None,"['Contusion', 'Immunoglobulin therapy', 'Injection site pain', 'Platelet count decreased', 'Platelet transfusion']",1,MODERNA,IM 934997,TX,73.0,F,"Started slight redness itching and swelling after 6 days, still has that. Tropically applied te over the counter .01 percent cortisone ointment.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/04/2021,5.0,PVT,"Genuvia 100, cynthroid, Irbisarten",nothing,nothing,,Nothing my knowledge,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA,SYR 935003,OH,33.0,F,"Developed mouth ulcers on tongue and cheek. Very painful. Ongoing still, with slow regression of symptom for 4 days now started 2 days after vaccine received worse on tongue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,PVT,"multivitamin, Adderall XR, duloxetine",,"Asthma, Seasonal Allergies",,Amoxicillin,"['Mouth ulceration', 'Peptic ulcer', 'Tongue ulceration']",1,MODERNA,IM 935007,KY,32.0,F,"Pt received Covid 19 Moderna While waiting afterward reports chest tight, heart racing feeling flushed. SOA relieve by removing face mask. Reported this happened 2 wks ago & this happen prior to that & thought to be anxiety",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,PUB,,None,,,,"['Anxiety', 'Chest discomfort', 'Dyspnoea', 'Flushing', 'Palpitations']",1,MODERNA,IM 935021,PA,68.0,F,Client had numbness and tingling at the roof of her mouth 15 minutes after receiving the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,unknown,unknown,unknown,,Lactose Intolerant,"['Hypoaesthesia oral', 'Paraesthesia oral']",1,MODERNA,IM 935033,ME,20.0,F,Reports raised rash all overbody.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,0,0,0,,Seasonal allergies,"['Rash', 'Rash papular']",2,PFIZER\BIONTECH,IM 935057,KS,56.0,F,"Pt to report to the RN on the morning of 01/11/2021 that since she received the second dose of the Pfizer vaccine (COVID-10) that she had had disturbing nightmares. Pt reports that she had two night-mares after the 1st dose, but said the second dose she started having nightmares this morning. Pt declined evaluation at the clinic after reporting of the events. Other S/S she had experienced are headache, nausea, chills, weakness, feeling tired but symptoms have improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/11/2021,3.0,PVT,"Levothyroxine, cymbalta",None,Depression,,"Sulfa, TB test","['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Nausea', 'Nightmare']",2,PFIZER\BIONTECH,IM 935090,ME,62.0,F,"SOB, Sleeplessness,",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,WRK,"Metoprolol, Sertraline, irbesartan pantoprazole Vit B shot monthly Vit D2",Diarrhea and Gastric issues but not COVID related,"GERD, HTN, skin CA,",,"PCN Percocet, Darvocet, Heparin, Bees Has an Epi Pen","['Chest X-ray', 'Dyspnoea', 'Echocardiogram', 'Electrocardiogram', 'Insomnia', 'Laboratory test']",UNK,MODERNA,IM 935121,CA,,F,"Scratchy throat, cough, throat tightness improved with Benadryl 25mg oral. Observed for 15 minutes, able to drink water. Lungs CTA (B).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,SEN,,,,,Allergic rhinitis,"['Cough', 'Throat irritation', 'Throat tightness']",UNK,PFIZER\BIONTECH,IM 935135,CA,,F,Sx: Cough & tightening in throat. Tested Binax for Covid - Negative POC Test. Tx: Claritin Tablet Personal Inhaler,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,OTH,,No,Reaction to flu vaccine; Respiratory Illness,Tightening in throat/rash~Influenza (Seasonal) (no brand name)~1~0.00~Patient,,"['Cough', 'Throat tightness']",1,PFIZER\BIONTECH,IM 935180,ND,28.0,F,"Scratchy throat, dizziness and eventually feeling like her throat is closing in",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,Unknown,Unknown,"Asthma, Obesity",,Penicillin and Green Peppers,"['Dizziness', 'Throat irritation', 'Throat tightness']",1,PFIZER\BIONTECH,IM 935222,FL,73.0,M,Patient was reported to be deceased at home by law enforcement on 1/7/21,Yes,01/07/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,"Oxybutynin Chloride, Lasix 80mg, hydyralazine 50mg, amlodipine 10mg, amitriptyline 10mg, ASA, Klor-Con 20meq, Tylenol, allopurinol 100mg, Vit D3, turmeric 400mg, Lipitor 80mg, gabapentin 100mg, baclofen 5mg, candesartan 32mg, insulin lispro",No acute illnesses,"Diabetes, CKD, CHF, HTN",,NKA,['Death'],1,MODERNA,IM 935266,WI,41.0,F,"Patient presents with abdominal pain that started in the middle of the night. Had first COVID vaccine the previous day. Patient states the pain is intermittent ""comes and goes"" ""cramping"" ""pressure and bloating"" feeling. Patient states her normal bowel movements are 12 times per day. The last time she went was this morning. She is concerned about an ""obstruction"" Patient states she has ""some nausea"" She states she has ate and drank normally today. Patient has a history of ulcerative colitis and a complete colectomy with a ileal rectal pouch. She has had abdominal pain since this morning which is crampy, associated with nausea and recurrent vomiting. She normally has 6-12 bowel movements a day, but none since this morning. She does feel her abdomen is distended as well. The last time she had anything like this was when she developed pouch itis last spring, but that was much less painful than this. Her appendix is gone, but she believes she still has her gallbladder.",Not Reported,,Not Reported,Yes,4.0,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Abdominal discomfort', 'Abdominal distension', 'Abdominal pain', 'Bowel movement irregularity', 'Nausea', 'Vomiting']",1,MODERNA,IM 935310,NY,52.0,F,Went into the ED for bilateral hand and feet tingling. Worked up for possible Guillain Barre.,Not Reported,,Not Reported,Yes,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,,['Paraesthesia'],2,PFIZER\BIONTECH,IM 935338,KS,44.0,M,"Patient reported stroke-like symptoms as he was driving to work: started ""feeling funny"" with dizziness; progressed to feeling weakness in left side of face with facial drooping; tingling in left hand progressed to numbness and weakness in left arm and leg; difficultly coordinating motor movement in right arm; difficulty/ diminished speech ""tongue felt fat."" Symptoms resolved within appx 1+ hour from onset. Per patient, he was given an injection at the hospital (unsure for what?) and was discharged with a prescription for chlorthalidone 25mg daily, blood pressure was elevated.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/06/2021,01/09/2021,3.0,PUB,None,None,"Hypertension, obesity, DM type II",,NKA,"['Blood pressure increased', 'Blood test', 'Computerised tomogram head', 'Dizziness', 'Facial paralysis', 'Facial paresis', 'Feeling abnormal', 'Hypoaesthesia', 'Motor dysfunction', 'Muscular weakness', 'Paraesthesia', 'Paraesthesia oral', 'Speech disorder']",1,MODERNA,IM 935343,KS,89.0,F,"There were no adverse reactions. Resident Died, she had a history of issues with her health prior to the vaccine.",Yes,01/11/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/11/2021,3.0,SEN,,,This resident had covid a couple months ago. she had a bad heart and also dementia. I do not believe it was the vaccine that killed her. I was instructed by EMS to report because the date of vaccination was three days ago.,,,['Death'],UNK,PFIZER\BIONTECH,SYR 935350,TX,81.0,M,Patient was found unresponsive at home with SpO2 20% 1/2/2021,Yes,01/06/2021,Not Reported,Yes,4.0,Not Reported,N,12/31/2020,01/02/2021,2.0,PVT,Symbicort 160/4.5 mcg/act inhaler Dilitiazem ER 360mg PO daily Eliquis 5mg PO twice a day Furosemide 20mg PO daily Losartan 100mg PO daily KCL 10mEq ER PO daily Ranitidine 150mg PO Ventolin HFA 0.09mg/1ACT 2 puffs every 4 hours as needed Me,"Dyspnea, Shortness of breath",Paroxysmal atrial fibrillation Hypertension Chronic iron deficiency anemia Congestive heart failure with chronic diastolic,,No known allergies,['Unresponsive to stimuli'],1,MODERNA,IM 935452,NM,44.0,F,"1/6/21 8pm started with Nasuea, vomiting, diarrhea and fever. 1/7/21 started having intermittent chest pain in the morning. Then in the evening it became constant. Went to ER that evening due to chest pain. EKG showed t wave abnormality. 1st Trop was negative went from 0.08 to 2.3 Had 2 Echo's done and they were normal. Platelets were 85. Was discharged without chest pain. Troponin on discharge was 0.67 and platelets 61. Was admitted due to Chest pain and troponin. Attending provider diagnosed as myocarditis and thrombocytopenia R/T vaccine.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,Multivitamin daily,no,no,,NKDA,"['Chest pain', 'Diarrhoea', 'Echocardiogram normal', 'Electrocardiogram T wave abnormal', 'Myocarditis', 'Nausea', 'Platelet count decreased', 'Pyrexia', 'Thrombocytopenia', 'Troponin increased', 'Vomiting']",2,PFIZER\BIONTECH,IM 935478,MA,34.0,F,"right after vaccine was given i got a head to toe hot flush. i thought it was just anxiety. within 2 minutes i had expolsive diarrhea, felt dizzy. looked in the mirror and saw my neck and chest covered in red rash and hives. felt hot flush again. dr came in noticed hives all over both my arms as well. felt sob and if someone was holding my neck with their hand. given benadryl and epi taken to local er.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,zyrtec 10mg ----- other daily meds not taken this day vitamin d otc lysine otc adderall xr 25 valacylovir 500 cymbalta 30mg spirolactone 100mg,na,"anxiety, adhd, acne",,cillins as baby-rash compazins-dizzy,"['Anxiety', 'Blood test', 'Diarrhoea', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Feeling abnormal', 'Hot flush', 'Immediate post-injection reaction', 'Rash', 'Rash erythematous', 'Urticaria']",1,MODERNA,IM 935511,SD,56.0,F,Patient received the 1st dose of Moderna and was found deceased in her home the next day.,Yes,01/09/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,unknown,none known of,history of vaginal adenocarcinoma- removed with surgery in 2019,,latex (skin reaction),['Death'],1,MODERNA,IM 935519,,34.0,F,"Patient is a 34 y.o. female who was seen at COVID Vaccine Clinic today for her dose of the COVID 19 vaccination. � She denied any history of previous adverse reactions to vaccines. � She was given the Moderna vaccination in the left deltoid muscle. � During her waiting period after the injection, the patient began to experience dizziness / lighheaded. She denied syncope, N/V, visual changes, headaches. � This provider was notified of patient reaction and she was then assessed in the emergency bay area. � Monitored patient for severe reaction symptoms, including but not limited to shortness of breath, swelling of the throat, Difficulty breathing, chest pains. Patient did not experience any of these symptoms � She is 18 weeks pregnant. No complications with pregnancy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,WRK,,,,,,"['Dizziness', 'Pregnancy']",1,MODERNA,IM 935552,HI,43.0,M,"In the first 2 days (probably a couple of hours after the shot) I felt achiness, and it got worse body pains, joint pains and fatigue. Almost a week after I started getting sick, aches, shore throat, headache and fever (101.5F) that is when I went to the ED and it lasted about 2 days and then it went away. At the ED they did COVID and strep tests both negative. This was with my first dose and my second one the same thing happened.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,MIL,"Gabapentin, naproxen, folic acid",No,No,,No,"['Arthralgia', 'Fatigue', 'Headache', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Streptococcus test negative', 'Vaccine positive rechallenge']",1,PFIZER\BIONTECH,SYR 935569,KS,46.0,F,"Pfizer COVID-19 Vaccine A couple hours after the vaccination the patient experienced pain in the vaccine arm, headache, and feeling ache. Day 1 post vaccination patient experienced sore arm, headache, low grade fever, feeling ache, and GI symptoms with diarrhea. Day 2 post vaccination patient experienced sore arm, Migraine, and diarrhea. Day 3 post vaccine patient woke up with chest pain that radiated into her left arm and some weakness. Patient's blood sugar was >500 and was admitted to hospital for DKA.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,Type 2 diabetes,,Sulfa: lip swelling Daptomycin: anaphylaxis Zosyn: lip swelling and hives Benadryl: Itching,"['Abdominal discomfort', 'Asthenia', 'Blood glucose increased', 'Chest pain', 'Diabetic ketoacidosis', 'Diarrhoea', 'Headache', 'Migraine', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 935689,NY,36.0,F,"12 hours after receiving the shot I came down with chills, fever, and body aches. I had three bouts of this over the next 24 hours. The second one had a spike in fever just over 101. I monitored my symptoms closely and used Tylenol as recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Rx: Levothyroxine Supplements: prenatal vitamins, DHA, calcium, vitamin d, turmeric",None,None,,None,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 935767,CA,85.0,F,My mother was given Pfizer vaccine on Thursday and she died 3 days later yesterday on Sunday!!!,Yes,01/10/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/10/2021,3.0,SEN,IDK,Pneumomia,Dementia,,IDK,"['Death', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH,UN 935780,OH,61.0,F,"Extremely tired went to bed at 8:30. At 11:00, tossed and turned until 12:16 a.m. Did not think she could stand up. Walked in the bathroom had pain in stomach, was very hot and freezing at the same time, was shaking. Head hurt was hurting so bad. Tried standing up from toilet, was passed out. Eye, half of face is bruised and swollen , eye shut for two days. More than forty minutes passed before she could call her husband. Does not remember anything because she was passed out. Husband came in and grabbed her, to get her back into bed. she could not stand. Went to ER at Hospital. Had CT scan, blood work , EKG, chest xray. Was still kind of out of it but was able to communicate with nurses. Face is still black and blue. Last night got up at 4:00 a.m. something was wrong with her throat. Felt like a walnut was in her throat. Went to doctor this morning. They said it was a reaction from the shot. Got an EpiPen, prednisone. Call them in 2 days to let them know how she's doing and also wear a heart monitor because they do not know how to take care of her, Has had vision blurriness in both eyes. Has not felt well at all.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,"Levothyroxyn, Lisinopril",no,Thyroid,,"Penicillin, Amoxicillin, Sulfur, pineapple","['Abdominal pain upper', 'Blood test', 'Chest X-ray', 'Computerised tomogram', 'Contusion', 'Dysstasia', 'Electrocardiogram', 'Eye contusion', 'Fatigue', 'Feeling of body temperature change', 'Headache', 'Loss of consciousness', 'Malaise', 'Memory impairment', 'Poor quality sleep', 'Sensation of foreign body', 'Swelling face', 'Swelling of eyelid', 'Tremor', 'Vaccination complication', 'Vision blurred']",1,MODERNA,IM 935815,CA,63.0,M,"Difficulty breathing, death.",Yes,01/05/2021,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,SEN,,,,,,"['Death', 'Dyspnoea']",UNK,PFIZER\BIONTECH, 935849,OH,39.0,F,"Noted left lymph nodes left neck. On January 7, 10 days post injection had acute appendicitis requiring emergency appendectomy.",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/01/2020,01/05/2021,35.0,PVT,None,None,None,,None,"['Appendicectomy', 'Appendicitis', 'Computerised tomogram abdomen', 'Computerised tomogram pelvis', 'Full blood count', 'Lymphadenopathy', 'Ultrasound pelvis']",1,MODERNA,IM 935918,AL,74.0,F,"Lightheaded, nausea Outcome -> signs & symptoms form submitted for COVID test",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/10/2021,0.0,OTH,"metropolol 25mg, Atorvastatin 25 linispril 10mg, HCTZ 12.5mg",,HTN,,"demerol, morphine, clonocline","['Dizziness', 'Nausea', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH,ID 935919,AL,50.0,F,"Dizzy, Room Spinning, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,PVT,"Zoloft, Trazodone, NP Thyroid",n/a per employee,Hypothyroidism,,Codiene,"['Dizziness', 'Headache', 'Vertigo']",2,PFIZER\BIONTECH,IM 935927,,48.0,F,"After vaccination, patient was ok, talking and eating. Suddenly, patient complains of dizziness, and ""didn't feel right"". Patient was laid flat on a couch, but then passed out and was not responsive to sternal rub. After a code was called, the patient woke up. At no time was there a loss of pulse or SOB. Patient was transported to the ER and was subsequently discharged same day. Patient did report that prior to the vaccination, she ran 13 miles in the morning, which may have had something to do with the reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,unknown,unknown,unknown,,unknown,"['Dizziness', 'Feeling abnormal', 'Loss of consciousness', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 935939,CA,38.0,F,"Metallic taste in the back of throat between 15-20 minutes post vaccination, noticeable swallowing and throat irritation at 20-25 minutes post vaccination, tongue and lip numbness and throat tightness at 25-30 minutes, dry hacking cough at 30 minutes. Treated in the ED approximately 1 hour post vaccination, at time of arrival in respiratory distress with subcostal retractions, coughing, speaking 1-2 word sentences, with tachycardia and tachypnea. Treated with IM epinephrine, IV solumedrol and IV Benadryl and IV Benadryl with marked improvement in symptoms.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,None,None,None,,None,"['Cough', 'Dysgeusia', 'Dysphagia', 'Hypoaesthesia oral', 'Respiratory distress', 'Speech disorder', 'Tachycardia', 'Tachypnoea', 'Throat irritation', 'Throat tightness', 'Use of accessory respiratory muscles']",2,PFIZER\BIONTECH,IM 935978,CA,62.0,M,Woke up 1/4/21 with right sided facial weakness consistent with Bell's Palsy. Started high dose Prednisone and Valtex. Received IVIG infusion on 1/6/21 and 1/7/21. Mild improvement 1/11/21.,Not Reported,,Not Reported,Not Reported,,Yes,N,12/19/2020,01/04/2021,16.0,PVT,None,None,None,,None,"['Facial paralysis', 'Facial paresis', 'Immunoglobulin therapy']",1,PFIZER\BIONTECH,IM 935984,CO,29.0,F,"About 15 minutes after vaccine, hr 155, fever 102, covered in hives, sick to her stomach and a pounding headache. Has had headache since then and been extremely fatigue.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/21/2020,12/21/2020,0.0,PVT,Birth control,no,"Lyme Disease, Heart Condition",,"peanuts,","['Abdominal discomfort', 'Blood test', 'Fatigue', 'Headache', 'Pyrexia', 'Urticaria']",1,PFIZER\BIONTECH,IM 936011,CA,33.0,F,"Anaphylaxis within 5 minutes of dose given. Tachycardia 130-140s, hot body temperature, trouble swallowing, lightheaded/dizzy, ekg changes, feeling like I was going to pass out even when in bed. IV fluids, benedryl, soul-medrol, famotadine and IM epi given.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,No change from dose #1,No,Chronic severe idiopathic neutropenia,,Possibly NSAIDs or unknown,"['Anaphylactic reaction', 'Blood potassium decreased', 'Dizziness', 'Dysphagia', 'Electrocardiogram change', 'Feeling hot', 'Hypokalaemia', 'Metabolic function test', 'Tachycardia']",2,PFIZER\BIONTECH,IM 936026,ND,37.0,F,"Trouble swallowing, tingling around the mouth within 5 minutes of vaccine administration. IV started with 25mg Benadryl within 5 minutes of symptom onset. Transfer to ER at 1430. Symptoms unresolved, hr - 120, bp 140/100, O2 sats 100, resp: 21 Additional 25mg Benadryl, 125mg solumedrol, 1ml Ativan given IV at 1435. Symptoms began to resolve, patient discharged at 1600 to home with instructions to return if needed. Patient returned to ER Sunday January 10 at 1300 complaining of throat tightness. Patient was seen by doctor, no acute distress and airway issues seen. Patient elected to stay for 50mg benadryl and 40mg prednisone PO. Patient was discharged to home with script for 40mg prednisone q day for 3 days. Patient feels any remaining allergic symptoms have resolved.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Omeprazole Lexapro 10mg,None,Anxiety Genital herpes TMJ disorder,,Penicillin,"['Dysphagia', 'Paraesthesia oral', 'Throat tightness']",2,PFIZER\BIONTECH,IM 936043,CA,98.0,F,"RESIDENT 1ST DOSE OF MODERNA VACCINE ADMINISTERED ON 01/04/2021 AT 8:30PM, RESIDENT FOUND UNRESPONSIVE ON 01/05/2021.",Yes,01/05/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,SEN,"atorvastatin,senna,MultiVitamin,Metamucil,metformin,Levothyroxine","S82.001D Unspecified fracture of right patella, subsequent encounter for closed fracture with routine healing(Primary, Admission), M62.81 Muscle weakness (generalized), R29.3 Abnormal posture, M19.90 Unspecified osteoarthritis, unspecified site, E11.9 Type 2 diabetes mellitus without complications, Z86.73 Personal history of transient ischemic attack (TIA), and cerebral infarction without residual deficits, E03.9 Hypothyroidism, unspecified, E78.5 Hyperlipidemia, unspecified, F03.90 Unspecified dementia","S82.001D Unspecified fracture of right patella, subsequent encounter for closed fracture with routine healing(Primary, Admission), M62.81 Muscle weakness (generalized), R29.3 Abnormal posture, M19.90 Unspecified osteoarthritis, unspecified site, E11.9 Type 2 diabetes mellitus without complications, Z86.73 Personal history of transient ischemic attack (TIA), and cerebral infarction without residual deficits, E03.9 Hypothyroidism, unspecified, E78.5 Hyperlipidemia, unspecified, F03.90 Unspecified dementia",,PENICILLINS,['Unresponsive to stimuli'],1,MODERNA,IM 936149,VA,49.0,M,Herpatic infection left eye causing a herpatic dendrite,Not Reported,,Not Reported,Not Reported,,Yes,N,12/23/2020,12/26/2020,3.0,PVT,"Lisinopril, metoprolol, eliquis, multivitamin",None,"Heart failure, A-fib, sleep apnea, HTN",,Latex,"['Herpes ophthalmic', 'Ophthalmic herpes simplex', 'Ophthalmological examination']",1,MODERNA,IM 936151,MT,46.0,F,"One week after administration, I had sudden onset inability to move left arm. I was transported to ER immediately. Treated, scanned with CT of brain, MRI of brain, c-spine and brachioplexus. In hospital for 2 days and no answers. Still no answers to left arm paresthesia and proprioreceptor deficits. Spreading into left leg and mild systemic symptoms. I have been to the ER, seen by primary physician, Physiatrist and Neurology and Occupational Therapy. I am scheduled for many more appointments and trying to find and answer.",Not Reported,,Not Reported,Yes,2.0,Yes,N,12/16/2020,12/23/2020,7.0,PVT,Synthroid 6 am,"R/O Covid infection, COVID test was negative December 4, 2020. Primary Care MD diagnosed me with COVID after symptoms consistent with the virus on December 14, 2020.","Hypothyroidism, Migraine headaches, IBS",,"Morphine, extrapyramidal reaction to reglan","['Blood test', 'Computerised tomogram head', 'Loss of proprioception', 'Magnetic resonance imaging', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging spinal', 'Mobility decreased', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 936473,IN,32.0,F,"Currently pregnant, 23 weeks. 21 weeks at the time of injection. A little after an hour are receiving injection itching began on jaw then progressed to other areas of the body. Arms, hands, belly, feet, head, and legs. Itching was not intense and could be ignored, no medication taken. Itching subsided after 24 hours but has returned on/off since. Message was sent to OBGYN asking for MD to contact me if he felt issue was urgent. No contact made but since issue persists will call and ask for lab work.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,Pre natal vitamins-smarty pants gummies nordic naturals fish oil iron supplement,None,Depression Anxiety,,None,"['Exposure during pregnancy', 'Pruritus']",1,PFIZER\BIONTECH,IM 936740,CA,39.0,F,"12:30 pm - Numbness to roof of mouth, upper lip swelling, tongue swelling/tingling 12:45 pm - 2 tabs Allegra taken (180 mg each??) 2:30 pm - Swelling subsided 4:30 pm - Upper lip swelling returned 5:00 pm - Additional 2 tabs of Allegra taken Reaction stopped at 6:30pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,WRK,None,None,Asthma,,"Sulfas, Clindamycin, Amoxicillin, Co-Trimoxazole, Dogs, Cats,","['Hypoaesthesia oral', 'Lip swelling', 'Paraesthesia oral', 'Swollen tongue']",1,MODERNA,IM 936741,CA,42.0,F,"-day after vaccine, experienced headache, temp of 101, body aches/chills, no appetite. -headache lasted for 24hrs after, body aches chills decreased w/tylenol. Still decreased appetite until 3rd day fever was down to 99-100 w/tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/28/2020,12/29/2020,1.0,WRK,,,,,,"['Body temperature increased', 'Chills', 'Decreased appetite', 'Headache', 'Pain']",2,PFIZER\BIONTECH, 936751,CA,56.0,F,"12:30 pm - Itching noted to upper back. 12:40 pm - Developed hives to back, back side of arms, around torso. 12:45 pm - Zyrtec 10 mg taken 1:30 pm - Developed chest tightness, congestion, coughing and shortness of breath. 2:00 pm - Itching subsiding, hives unresolved for an additional hour or two. Continued taking Zyrtec for three days due to continued coughing, congestion, and shortness of breath. Symptoms all resolved by 01/09/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,None,None,None,,"Claritin, Cantaloupe","['Chest discomfort', 'Cough', 'Dyspnoea', 'Pruritus', 'Respiratory tract congestion', 'Urticaria']",1,MODERNA,IM 936763,NY,60.0,M,"pt states experienced headache, soar throat, bone pain to (R) hand, chills, and low grade fever onset night of vaccination lasting 2-3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Testosterone,None,"Asthma, Metabolic Syndrome HTN, DM",,Tetracycline,"['Bone pain', 'Chills', 'Headache', 'Oropharyngeal pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 936775,NY,60.0,M,c/o severe headache & generalized body aches; Temp 100.8; dizzy/faint symptoms relieved by Tylenol 1000 mg PO. after lasting from 1/8/21 - 1/9/21,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"B-Complex, MVI, Omega-3 Vit D, Calcium",None,SCT,,None,"['Body temperature increased', 'Dizziness', 'Headache', 'Pain']",1,MODERNA,IM 936783,CT,40.0,F,C/o headaches onset 12/26 x4 days; Nausea chills onset 12/30 x 2 days; Body aches onset 1/1/21 x 4 days. Visited urgent care 1/2/21 - labs done & released w/ return to work 2-5 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/26/2020,5.0,PVT,qvar IH,None,Asthma,,"peanuts, eggs, Percocet, morphine Fentanyl, Iodine","['Chills', 'Headache', 'Influenza virus test negative', 'Mononucleosis heterophile test negative', 'Nausea', 'Pain', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 936790,NY,43.0,F,"30 minutes after receiving vaccine bilateral numbness/tingling to hands 60 minutes after ""chemical taste"" in mouth with dryness lasting entire day; 6-8 hours after headache; fatigue x 1-2 days; arm pain swelling x 2days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Advil,None,None,,dairy; codeine,"['Dry mouth', 'Dysgeusia', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Pain in extremity', 'Paraesthesia', 'Peripheral swelling']",1,MODERNA,IM 936796,CA,39.0,F,"vaccine at 0730, at 0740 vomited in Bathroom 0750 - nausea continues 0800 - mild nausea, improving, pt went home",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2020,01/10/2020,0.0,PVT,"Methimazole, Atorvastatin",Hyperthyroidism,,nausea aFter last Covid Vaccine,,"['Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 936802,CA,33.0,M,Pt. became tachacardic post 2nd vaccine injection. BP 155/99 HR 130-140 Lightheaded. No shortness of Breath. Discharged at 1515 - okay.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,,,Mild CKD,,Tree nuts,"['Dizziness', 'Tachycardia']",2,PFIZER\BIONTECH, 936809,CA,51.0,F,"0900 - Vaccine given 0910 - felling warm all over, fast HR, itchy arm at injection site (x5min) 0920 - symptoms improving",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/10/2021,01/10/2021,0.0,PVT,"Fosamax, Lexapro, Xalatan eye drops.",,"(1) Osteoporosis, (2) ? myasthenia gravis (3) Glaucoma (4) pulmonary hypertension (5) PPRD",,None,"['Feeling hot', 'Heart rate increased', 'Injection site pruritus']",1,PFIZER\BIONTECH,IM 936173,PR,29.0,F,"pain in the left armpit; a small protrusion in the area of the left collarbone which hurts to the touch; a small protrusion in the area of the left collarbone which hurts to the touch; feeling headache; tiredness; chills; bnt162b2 first dose on 15Dec2020 at 14:30 and then second dose on 04Jan2021 at 15:30; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK4176), intramuscularly on 04Jan2021 at 15:30 on Arm Left at single dose for COVID-19 immunization in hospital. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. No concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, nor any other medications within two weeks of vaccination. The patient previous took acetylsalicylic acid (ASPIRIN) and experienced allergy; first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 15Dec2020 at 14:30 on Arm Left at single dose for COVID-19 immunization and had pain in her left arm where it was administered the vaccine on 15Dec2020 at 15:00, the next day (16Dec2020) the area was red and inflamed, the redness and the inflammation lasted three days. The patient experienced hours after receiving the second dose of the vaccine she began feeling headache, tiredness and chills on 04Jan2021 at 21:00. The next day of the vaccine on 05Jan2021 she began feeling pain in the left armpit and she had a small protrusion in the area of the left collarbone which hurts to the touch. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Axillary pain', 'Bone disorder', 'Bone pain', 'Chills', 'Fatigue', 'Headache', 'Inappropriate schedule of product administration']",2,PFIZER\BIONTECH,OT 936174,PR,29.0,F,"have pain in my left arm where it was administered the vaccine/the area was red and inflamed; have pain in my left arm where it was administered the vaccine/the area was red and inflamed; pain in my left arm where it was administered the vaccine; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 15Dec2020 at 14:30 on Arm Left at single dose for COVID-19 immunization in hospital. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. No concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, nor any other medications within two weeks of vaccination. The patient previous took acetylsalicylic acid (ASPIRIN) and experienced allergy. The patient experienced started to have pain in her left arm where it was administered the vaccine on 15Dec2020 at 15:00. The next day (16Dec2020) the area was red and inflamed. The redness and the inflammation lasted three days. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events 'redness and the inflammation' was recovered on 19Dec2020, outcome of the other event was unknown. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/15/2020,12/15/2020,0.0,PVT,,,,,,"['Vaccination site erythema', 'Vaccination site inflammation', 'Vaccination site pain']",1,PFIZER\BIONTECH, 936177,NJ,70.0,U,"Bell's palsy; Information has been received from a lawyer and an elderly patient of unknown age and gender, regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In or about 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a healthcare provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX): Bell's palsy. The outcome of the event was unknown. Upon internal review, Bell's palsy was determined to be medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Facial paralysis'],UNK,MERCK & CO. INC.,OT 936192,NJ,24.0,F,"Passed out twice; Pain in the injection site; Slight headache; A spontaneous report was received from a consumer concerning a 24-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, passed out twice, pain in the injection site, and slight headache. The patient's medical history was not reported. No concomitant medications were reported. On 26 Dec 2020 at 1:58 pm, approximately three hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L2DA) intramuscularly for prophylaxis of COVID-19 infection. On 26 Dec 2020, at 5:00 pm, the patient passed out. She also had pain in the injection site and a slight headache. On 27 Dec 2020, at 8:30 am, the patient passed out again. No treatment information was provided. The Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events, passed out twice, pain in the injection site, and slight headache was unknown.; Reporter's Comments: This case concerns a 24 year old female patient, who experienced a serious unexpected event of loss of consciousness and non-serious expected event of injection site pain and headache. The event occurred apparently few hours after first dose of mRNA-1273 (Lot # 026L2DA) administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/26/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Headache', 'Injection site pain', 'Loss of consciousness']",1,UNKNOWN MANUFACTURER,OT 936193,CA,34.0,F,"Shortness of breath; Tingling; Numbness of body, face, neck; Tachycardia at 144; Palpitation; Elevated BP at 140/90; Chest tightness; Dizziness; Flushing of face; A spontaneous report was received from a physician, who was a 34-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness of body, face, and neck, tingling, tachycardia at 144, palpitation, elevated blood pressure (BP) at 140/90, chest tightness, shortness of breath, dizziness, and flushing of face. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Dec 2020, three to four minutes after receiving the mRNA-1273 vaccine, the patient experienced numbness of body, face, and neck, tingling, tachycardia at 144, palpitation, elevated BP at 140/90, chest tightness, shortness of breath, dizziness, and flushing of face. The patient reported the elevated BP was not her usual blood pressure. She underwent an electrocardiogram (EKG)unknown results and was given oxygen for the events. No other treatments were administered. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, numbness of body, face, and neck, tingling, tachycardia at 144, palpitation, elevated BP at 140/90, chest tightness, shortness of breath, dizziness, and flushing of face, was considered resolving.; Reporter's Comments: This case concerns a 34 year old female patient, who experienced a serious unexpected event of hypoesthesia and paraesthesia and non serious unexpected events of dyspnea, tachycardia, palpitations, blood pressure increased, chest discomfort, dizziness and flushing. The event occurred within 3-4 min after first dose of mRNA-1273 (Lot# 025J20-2A) vaccine administration. The patient was treated with oxygen and no medication was administered. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Blood pressure increased', 'Chest discomfort', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Flushing', 'Hypoaesthesia', 'Palpitations', 'Paraesthesia', 'Tachycardia']",1,UNKNOWN MANUFACTURER,OT 936194,OR,63.0,F,"Soreness injection site; The initial case was missing the following minimum criteria: unspecified product and adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable healthcare professional, the patient, from a Pfizer sponsored program. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the arm on 23Dec2020 (at the age of 63-years-old) as a single dose for COVID-19 immunization. Medical history included penicillin allergy and anaphylaxis to a penicillin type drug. The patient's concomitant medications were not reported. The patient previously took ampicillin (MANUFACTURER UNKNOWN) from an unknown date to an unknown date for an unknown indication and experienced drug allergy. On 23Dec2020, the patient experienced soreness at injection site. The patient did not receive any treatment for the event. The clinical outcome of the soreness at injection site was recovered in Dec2020 after about 48 hours. The reporter considered that there was a reasonable possibility that the soreness at the injection site was related to the vaccine. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Anaphylaxis (to a penicillin-type drug); Penicillin allergy,,,['Vaccination site pain'],UNK,PFIZER\BIONTECH, 936195,NH,,M,"site soreness; arm is starting to get red with an induration under the injection site; arm is starting to get red with an induration under the injection site; The site was warm; This is a spontaneous report from a contactable other health professional. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: EL0140, via an unspecified route of administration in the right deltoid from 23Dec2020 at a SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included atorvastatin (LIPITOR). The patient experienced site soreness. He also indicated that his arm was starting to get red with an induration under the injection site. The site was warm. Outcome of events was unknown. No treatment was required/received due to events. No follow-up attempts possible. No further information expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,,,UNK,LIPITOR,,,,,"['Erythema', 'Vaccination site induration', 'Vaccination site pain', 'Vaccination site warmth']",UNK,PFIZER\BIONTECH, 936196,FL,,F,"my throat is extremely painful; it hurts to swallow; my throat started feeling a little scratchy 2 hours after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration into the left deltoid on 02Jan2021 at 10:00 as singe dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported "" my throat is extremely painful "" on 02Jan2021 with outcome of unknown; "" it hurts to swallow on 02Jan2021 with outcome of unknown; "" my throat started feeling a little scratchy 2 hours after receiving the vaccine "" on 02Jan2021 with outcome of unknown. The events were detailed as follows: patient received her 1st vaccine, then described the following: I feel ok but my throat is extremely painful and it hurts to swallow. My throat started feeling a little scratchy 2 hours after receiving the vaccine. Therapeutic measures were taken as a result of the events and included ibuprofen (ADVIL) 400 mg orally at 2:30 pm, helped some and was also reported as hurting more now because she needed to take more medicine. The outcome of events was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,UNK,,,,,,"['Odynophagia', 'Oropharyngeal pain', 'Throat irritation']",1,PFIZER\BIONTECH, 936197,WI,60.0,F,"Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: K5730, via an unspecified route of administration from 29Dec2020 16:15 at a SINGLE DOSE for covid-19 immunization. Medical history included migraine with aura. Concomitant medication included gabapentin, pravastatin, estradiol, diphenhydramine hydrochloride (ALLERGY), and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM). The patient previously took amoxicillin and had allergies. On 30Dec2020 15:00, the patient experienced pain at injection site, tiredness, chills, joint pain, fever and felt paralyzed at one point. The outcome of events was recovering. No follow-up attempts possible. No further information expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,; ; ; ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]; VITAM,,Medical History/Concurrent Conditions: Migraine with aura,,,"['Arthralgia', 'Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 936198,MI,34.0,F,"I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration into the left arm on 30Dec2020 at 11:00 as single dose for an unspecified indication. Medical history included penicillin allergy, sulfa allergy and allergy to nuts from an unspecified date. There were no concomitant medications. The patient experienced allergic reaction, throat pain, swollen uvula, itching in mouth and throat and shaking that was reported as ""had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula"" on 30Dec2020, at 11:15. The events were reported to have resulted in emergency room/department or urgent care. The events were reported as non-serious. Therapeutic measures were taken as a result of the events: treatment included antihistamine and steroids. Prior to vaccination, the patient had not diagnosed with COVID-19, not had she been tested for COVID-19 since the vaccination. The outcome of events was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Allergy to nuts; Penicillin allergy; Sulfonamide allergy,,,"['Drug hypersensitivity', 'Enlarged uvula', 'Oral pruritus', 'Oropharyngeal pain', 'Throat irritation', 'Tremor']",1,PFIZER\BIONTECH, 936199,MI,46.0,F,"Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizziness, tiredness and over all not feeling well; This is a spontaneous report from a contactable healthcare professional, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 31Dec2020 at 15:30 as a single dose for COVID-19 immunization. Medical history included allergy to tomatoes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 21:00, the patient experienced soreness in my arm, dizziness, tiredness and overall not feeling well. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the soreness in my arm, dizziness, tiredness and overall not feeling well were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Vegetable allergy,,,"['Dizziness', 'Fatigue', 'Malaise', 'Pain in extremity']",1,PFIZER\BIONTECH, 936200,,51.0,F,"body aches (just legs ache); very mild sore arm; fatigue; This is a spontaneous report from contactable nurse (patient) from a Pfizer-sponsored program. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 28Dec2020 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history included possible exposure to COVID-19 patient on 22Dec2020 to 23Dec2020 (patient's patient tested positive on 24Dec2020 and saw the patient on 22Dec2020 and 23Dec2020). The patient's concomitant medications were not reported. The patient experienced fatigue on 28Dec2020, very mild sore arm on 29Dec2020, and body aches (just legs ache) on 02Jan2020. The clinical course was reported as: The patient felt fatigue on the day of vaccination and very mild sore arm the next day. The patient experienced body ache (just legs) on 02Jan2021, but it was less on 03Jan2021. The clinical outcome of fatigue and very mild sore arm was unknown and of body aches (just legs ache) was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Exposure to COVID-19 (patient's patient tested positive on 24Dec2020 and saw the patient on 22Dec2020 and 23Dec2020.),,,"['Fatigue', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 936201,,,F,"Itchy everyday since then all over body; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included allergies to cilantro and iron. The patient's concomitant medications were not reported. The patient received vaccine on 28Dec2020 and reported she had been itchy every day since then all over body. Treatment for the event included diphenhydramine hydrochloride (BENADRYL). The outcome of the event, itchy, was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Food allergy,,,['Pruritus'],UNK,PFIZER\BIONTECH, 936202,NY,62.0,F,"some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was really scared; Excruciating pain on left ear; swelling in arm; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: ES1685, Expiry date: 01Mar2021) via intramuscular (left deltoid) on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She stated she is very healthy and don't have any medical conditions. She further stated that it was a scary moment, she don't want to take any chances, she was really frightened (28Dec2020). She made a complaint to let know her experience with the vaccine. Her cousin took the vaccine and told her she needed to report these events. The patient stated she experienced side effects after the first dose of the vaccine: Excruciating pain on left ear, locked jaw, her left upper arm was hurting on 28Dec2020. The pain went in her jaws and she was unable to open her mouth on 28Dec2020. She took 2 Benadryl and it relieved her. She saw on television if you experienced any side effects to take Benadryl. She also took Tylenol for the pain. She also had swelling in arm on an unspecified date in Dec2020. She also experienced some memory loss described as short-term memory loss on 30Dec2020. She stayed in bed after the vaccine, she was really scared, and stated she had memory loss and she don't have any memory problems. She was unable to remember if her car was black. She was looking for a white car. She drives a black car. She stayed in bed all day on Tuesday. Patient was asking what will happen if she does not take the second vaccine. The same morning while she was waiting to get the vaccine, a co-worker sent her a video of a woman who had received a COVID vaccine. She does not know which one. The woman experienced Bell's Palsy. The woman was crying and her face was turning side ways. She stated some people were talking negatively about the vaccine. She stated doesn't want her face to be deformed. She stated what are the cons of not taking the second vaccine. Reporter assessed the events as non-serious. Outcome of the events some memory loss and locked jaw/unable to open mouth was recovered on 30Dec2020, outcome of the events excruciating pain on her left ear, pain went in her jaws, her arm was hurt was recovering. Outcome of swelling in arm and she was really scared was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/01/2020,,UNK,,,,,,"['Amnesia', 'Ear pain', 'Fear', 'Pain in extremity', 'Pain in jaw', 'Peripheral swelling', 'Trismus']",UNK,PFIZER\BIONTECH,OT 936203,NC,,F,"fever; tachycardia; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age (pregnancy status not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on 03Jan2021 as a single dose for COVID-19 immunization. Indication. Medical history and concomitant medications were not reported. I was not known if the patient received other vaccinations in last 4 weeks or if she took any medications in the past 2 weeks. It was not reported if the patient had been tested for COVID-19 prior to the vaccination. The patient reported fever, tachycardia following administration of vaccine. She was scheduled to receive second dose 30Jan2021 and was questioning safety of second administration. The clinical outcome of the fever and tachycardia was not reported. It was unknown if the patient was tested for COVID-19 after the vaccination. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,UNK,,,,,,"['Pyrexia', 'Tachycardia']",1,PFIZER\BIONTECH, 936204,MI,53.0,F,"Shingle type pain burning; Shingle type pain burning; Shingle type pain burning; tingling; very sensitive from left flank down toward mid buttocks slightly toward anterior area; This is a spontaneous report from the Medical Information Team. A contactable nurse reported that a 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, via intramuscular route of administration in the left arm, from 24Dec2020 08:15 at a single dose for COVID-19 immunization. Patient had no other medical history (reported as ""none""). Concomitant medication included melatonin, calcium and bupropion hydrochloride (WELLBUTRIN). The patient is not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 27Dec2020 09:00, the patient experienced shingle type pain burning, tingling and very sensitive from left flank down toward mid buttocks slightly toward anterior area. The outcome of events was reported as ""not recovered"". Therapeutic measures were taken as a result of events included motrin, tylenol and lidocaine. Patient was unable to go to work for a few days. No follow-up attempts are possible. No further information is expected. Information on the batch number has been obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/27/2020,3.0,PVT,; ; WELLBUTRIN,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Burning sensation', 'Herpes zoster', 'Pain', 'Paraesthesia', 'Sensitisation']",1,PFIZER\BIONTECH,OT 936205,NY,41.0,F,"She got her period two weeks early; This is spontaneous report from a contactable Nurse. This Nurse reported similar events for 3 patients. This is the first of 3 reports, reporting for one of the colleagues. A 41-year-old female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730, exp: 31Mar2021, via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. She was ANA and double strand is positive for autoimmune but it is watch and see thing. Patient's other medical history and concomitant medications were not reported. Patient is not pregnant at the time of reporting. Reporter was wondering if other people were also reporting if they got their periods early. She got her period two weeks early (on 02Jan2021) and mentioned she also has two colleagues who had that as well on an unspecified date. The outcome of the event was reported as not recovered. Information on the lot/batch number has been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021004161 same reporter/drug/AE, different patient;US-PFIZER INC-2021004222 same reporter/drug/AE, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,PVT,,,,,,"['Double stranded DNA antibody', 'Menstruation irregular']",UNK,PFIZER\BIONTECH, 936206,CA,,F,"swollen lymph nodes in the armpit; arm pit pain; This is a spontaneous report from the Medical Information Team. A contactable other health professional reported that a 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 27Dec2020 at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was having arm pit pain, it felt like a swollen lymph node. She saw that this was a side effect. Outcome of events was unknown. Information about lot/batch number requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,,,UNK,,,,,,"['Axillary pain', 'Lymphadenopathy']",UNK,PFIZER\BIONTECH, 936207,OK,51.0,F,"COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; arm pain; she felt like crap the night; chills; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899, expiration date Mar2021), intramuscular on left arm, on 18Dec2020 at 0.3 mL, a single dose for vaccination. The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine and she tested positive with Covid. She received the Pfizer Covid vaccine on 18Dec2020. She was exposed to the virus through close personal contact right around this same time-frame and did develop the virus herself. She wanted to know if there were any recommendations regarding her needing to get the second dose in series. She stated that her husband, who was not vaccinated, had the virus and developed more serious symptoms than she did. She is concerned about worsening side effects with the second dose and stated that she felt like crap the night after her first dose with chills and arm pain. The patient tested positive for COVID-19 on 26Dec2020. Specific test name was unknown, but she knows it was not a rapid test. She is scheduled to get the second dose of the Pfizer COVID-19 Vaccine on 08Jan2021. She called to ask if she should or should not get the second dose relative to the COVID-19 diagnosis. She has not been able to find the information she is asking about. The outcome of the event of Covid-19 was recovering while other events was unknown. The Covid-19 was assessed as unrelated to the suspect drug.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 Nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment. COVID-19 antigen test positive.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,UNK,,,,,,"['COVID-19', 'Chills', 'Exposure to SARS-CoV-2', 'Feeling abnormal', 'Pain in extremity', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,OT 936208,MO,43.0,F,"welt on the injection site that was very hot and red; welt on the injection site that was very hot and red; welt on the injection site that was very hot and red; rash all over the body; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 43-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the left arm on 24Dec2020 (as reported) at 07:45 at 43-years-old at a single dose for COVID-19 immunization. Medical history included fibromyalgia, hypertension, and shellfish allergy; all from an unknown date and unknown if ongoing. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), ergocalciferol (VIT D); all taken for an unspecified indication from an unspecified date to an unspecified date (received within two weeks of vaccination). The patient previously took iodine (MANUFACTURER UNKNOWN) and experienced iodine allergy, and codeine (MANUFACTURER UNKNOWN) and experienced codeine allergy; both from an unspecified date to an unspecified date. On 17Dec2020 at 13:15 (as reported), the patient experienced: welt on the injection site that was very hot and red, and rash all over the body. The patient also reported, ""I have all the symptoms of COVID-19."" It was unknown if the patient received treatment for the adverse events. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Rapid test (SARS-CoV-2 test): negative on 04Jan2021. The clinical outcome of the events was not recovered. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/17/2020,,UNK,; ; VIT D,,Medical History/Concurrent Conditions: Blood pressure high; Fibromyalgia; Shellfish allergy,,,"['Rash', 'SARS-CoV-2 test', 'Vaccination site erythema', 'Vaccination site urticaria', 'Vaccination site warmth']",1,PFIZER\BIONTECH, 936209,NJ,59.0,F,"tested positive for Covid-19 after receiving 1st dose; COVID-19 PCR test: positive on 31Dec2020, Covid-19 rapid test: positive on 31Dec2020; smell was gone/no sense of smell; no sense of taste; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date unknown) via unspecified route of administration in the left arm on 26Dec2020 at single dose for Covid-19 immunization. Medical history included cholesterol, blood pressure (controlled blood pressure), hypothyroidism. Concomitant medications included TELMISARTAN (MICARDIS) for blood pressure and ATORVASTATIN (LIPITOR) for cholesterol; both on unspecified date. The patient was asking if she was able to get the 2nd dose of vaccine, since she was tested positive for Covid-19 (31Dec2020) after receiving 1st dose. The patient was asking information about missing 2nd dose and when can she get it and wanted to know if it was still okay to get the second dose. The patient asked if she needed to have a test negative for covid-19 prior to receiving 2nd dose. The patient experienced no sense of taste and actually realized it on 29Dec2020 that her food was not tasting good. The patient didn't notice her smell was gone until she was cooking the chicken curry, she even tested it out by spraying some perfume, she has no sense of smell on 30Dec2020. The patient informed that both her taste and smell returned 02Jan2021 but was not recovered completely. The patient underwent lab tests and procedures which included A1C: 6.4 on 12Dec2020, COVID-19 PCR test: positive on 31Dec2020, Covid-19 rapid test: positive on 31Dec2020. The patient informed that she had no positive test before the Covid-19 vaccine, she took Covid-19 antibody test in Apr2020 and it was negative. The outcome of the events tested positive for Covid-19 after receiving 1st dose was unknown, no sense of taste and smell was gone/no sense of smell was recovered with sequel on 02Jan2021.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/29/2020,3.0,UNK,MICARDIS; LIPITOR [ATORVASTATIN],,Medical History/Concurrent Conditions: Blood cholesterol abnormal; Blood pressure abnormal (controlled blood pressure); Hypothyroidism,,,"['Ageusia', 'Anosmia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 936210,AL,61.0,F,"congestion; positive for Covid-19; positive for Covid-19; This is a spontaneous report from a contactable healthcare professional (patient). A 61-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiration date not reported), via an unspecified route of administration on left arm on 31Dec2020 at 08:15 at a single dose for Covid-19 immunization/precaution because she works with hospice patients. Medical history included blood pressure (abnormal), diabetes, cholesterol (abnormal), and acid reflux, all are ongoing. The patient has no family medical history. Concomitant medications included amlodipine besilate, benazepril hydrochloride for blood pressure taking about 4-5 years, metformin for diabetes taking about 5 years, rosuvastatin for cholesterol Taking about 5 years, pantoprazole for acid reflux taking 5 years, and vitamin D as supplement taking for 3 years. No previous immunization nor vaccines administered on same date of the suspect drug. The patient was calling about the COVID vaccination, which she received on Thursday, 31Dec2020. Her husband tested positive on Thursday, so she took the test on Thursday after she took the vaccination and they just told her today, 04Jan2021, that she is positive for Covid-19. She wanted to know if that was going to mess up her vaccination in any way and if there are recommendations for second dose. She is a CNA. There was no prescriber. She received it because she works with hospice patients. Test was administered on 31Dec2020. COVID Test resulted on 10:00 04Jan2020 as positive. ER or physician's office required: She just went to get a COVID test when her husband tested and they gave her a azithromycin (Z-PACK) 250 mg because she had congestion. Take two tabs first day and then one daily for 4 more days. She is taking last one today (04Jan2021). Outcome of the events was unknown.; Sender's Comments: A causal association between reported events and BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/04/2021,4.0,PVT,AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE; ; ; ; VITAMIN D [VITAMIN D NOS],Acid reflux (esophageal); Blood cholesterol abnormal; Blood pressure abnormal; Diabetes,,,,"['Exposure to SARS-CoV-2', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 936211,LA,44.0,F,"slight sore arm; slight chest congestion; positive COVID-19 test after first dose of vaccine; positive COVID-19 test after first dose of vaccine; Fever; cold like symptoms; stuffy head; horrible headache; Cough; This is a spontaneous report from a contactable healthcare professional (patient) from a Pfizer-sponsored program, Pfizer First Connect. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 16Dec2020 as a single dose (reported as 0.3 mL) (at the age of 44-years-old) for COVID-19 immunization. Medical history included ongoing hypothyroidism, one thyroid gland removed due to a nodule on an unspecified date (years ago), ongoing acid reflux, ongoing hypercholesteremia, ongoing fluid retention, and ongoing history of headaches. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism and for one thyroid gland removed due to a nodule from an unspecified date and ongoing, dexlansoprazole (DEXILANT) taken for acid reflux from an unspecified date and ongoing, atorvastatin (LIPITOR) taken for hypercholesterolemia from an unspecified date to an unspecified date, and hydrochlorothiazide (MANUFACTURER UNKNOWN) taken for fluid retention from an unspecified date and ongoing. Additional concomitant medications included unspecified vitamins. The patient had a positive COVID-19 test after first dose of vaccine on 01Jan2021; cold like symptoms, stuffy head, horrible headache, cough, and fever on 31Dec2020; slight chest congestion on 02Jan2021; and slight sore arm on an unspecified date. The events, stuffy head and horrible headache, were reported as medically significant. The events, cough, fever, and slight chest congestion, were reported as non-serious. The clinical course was reported as follows: It was reported that the patient was vaccinated on 16Dec2020, became symptomatic on 31Dec2020, and tested positive for COVID-19 on 01Jan2021. The patient stated that she became symptomatic one day prior to testing positive for COVID-19, on 31Dec2020. She initially had cold-like symptoms with a stuffy head, cough and a horrible headache; the worst headache she had ever had. These symptoms occurred earlier in the day on the 31Dec2020. Then later that night about 10:00 PM, she had a fever with a body temperature of 102 degrees Fahrenheit. Her body temperature had been normal at 98 degrees all day that day until that night. She also had slight chest congestion and then was fever free for over 48 hours. The patient stated that she had a history of headaches and can tolerate a headache. The headache started 31Dec2020 and was significant. It was reported that after the vaccine, she had no other symptoms other than a slight sore arm, which lasted a day; maybe 24 hours after she received the vaccine. The patient stated that she does not think any of the other symptoms, other than the sore arm, have anything to do with the vaccine. The clinical outcome of positive COVID-19 test after first dose of vaccine and slight sore arm was unknown; cold like symptoms, horrible headache, and cough was recovering; fever was recovered on 02Jan2021; and stuffy head and slight chest congestion was not recovered. The reporter assessed the causality assessment between the events, positive COVID-19 test after first dose of vaccine, cold symptoms, stuffy head, cough, horrible headache, fever, and slight chest congestion, as unrelated. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/31/2020,15.0,PVT,SYNTHROID; DEXILANT; LIPITOR [ATORVASTATIN]; HCTZ,Acid reflux (esophageal); Fluid retention; Headache; Hypercholesteremia; Hypothyroidism,Medical History/Concurrent Conditions: Thyroid nodule (years ago); Thyroidectomy (years ago),,,"['Cough', 'Head discomfort', 'Headache', 'Nasopharyngitis', 'Pain in extremity', 'Pyrexia', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 936212,,32.0,M,"suspected COVID-19; suspected COVID-19; Fatigue; Body aches; Headache; chills; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable healthcare professional, the patient, from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), intramuscular in the left deltoid on 15Dec2020 at 21:00 (at the age of 32-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing hypertension from 2009 and COVID-19 from 10Jun2020 to an unknown date in 2020. Ongoing concomitant medications included fosinopril (MANUFACTURER UNKNOWN) taken for hypertension from 2017. The patient did not receive any other vaccines on the same day as the BNT162B2 vaccine. On 19Dec2020, shy of about 96 hours of getting the vaccine, the patient experienced fatigue, body aches, headache and chills. He did not have any fever. The patient stated that he recovered from the fatigue, body aches, headache and chills by 19Dec2020. The patient was fine from 19Dec2020 until 01Jan2021. On 28Dec2020, the patient had a COVID-19 PCR test that came back negative. On 01Jan2021, the patient suspected that he had COVID-19. He had a fever of 103.1 degrees Fahrenheit, body aches, chills like he was freezing to death, fatigue, diarrhea; however, he did not have nausea or loss of taste or smell. He had swollen lymph nodes, but no sore throat and his oxygen saturation was okay in Jan2021. He was also having chest pain but it was more like intercoastal pain. He stated that these current symptoms were significantly worse than the ones he had just after getting the vaccine and felt more like the symptoms he had when he had COVID-19 before on 10Jun2020 (positive IgG for COVID-19-tested in 2020). The patient had a COVID nasal swab (PCR) done at an urgent care (physician's office) on 02Jan2020 or 03Jan2020 and was awaiting the results. The clinical outcome of the suspected COVID-19 was not recovered.; Sender's Comments: A causal association between reported suspected COVID-19 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/15/2020,12/19/2020,4.0,UNK,,Hypertension,Medical History/Concurrent Conditions: COVID-19,,,"['Chest pain', 'Chills', 'Diarrhoea', 'Fatigue', 'Feeling cold', 'Headache', 'Lymphadenopathy', 'Musculoskeletal chest pain', 'Pain', 'Pyrexia', 'SARS-CoV-2 test', 'SARS-CoV-2 test negative', 'Suspected COVID-19']",1,PFIZER\BIONTECH,OT 936213,WA,38.0,F,"Swelling that looked like an egg under my arm, very visible very very sore; Swelling that looked like an egg under my arm, very visible very very sore/couldn't move my arm without it hurting; rash; hot to the touch; bruising; dizziness; nauseous; headache; body ache; muscle ache; very tired; joint pain; loss of appetite; This is a spontaneous report from a contactable healthcare professional. A 38-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ET1685, expiration date not reported), via an unspecified route of administration on the left arm, on 30Dec2020 at 11:45 at a single dose for Covid-19 immunization. Medical history included latex and shellfish allergy. Patient was diagnosed with Covid-19 prior to vaccination. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ergocalciferol (VITAMIN D), calcium, topiramate, and cyanocobalamin (vitamin B12). The patient previously took erythromycin, terbutaline, iodine and experienced drug allergies. On 30Dec2020 at 11:45, the patient experienced swelling that looked like an egg under her arm, very visible very very sore, rash, hot to the touch, bruising, dizziness, nauseous, headache, body ache, muscle ache, very tired, couldn't move arm without it hurting, joint pain, and loss of appetite. On 04Jan2021, the patient had a nasal swab and was tested for COVID-19, both with unknown result. The patient did not receive treatment for the events. The outcome of the events was recovering. The reporter assessed the events as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,OTH,VITAMIN D [ERGOCALCIFEROL]; ; ; B12 [CYANOCOBALAMIN],,"Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?:Yes); Latex allergy; Shellfish allergy",,,"['Arthralgia', 'Contusion', 'Decreased appetite', 'Dizziness', 'Fatigue', 'Feeling hot', 'Headache', 'Investigation', 'Myalgia', 'Nausea', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Rash', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 936214,,28.0,F,"Nausea; Swollen lymph nodes; tired all day; did not feel like herself-like she had the flu; soreness; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246), intramuscular in the right arm on 02Jan2021 at 11:45 as a single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome, prehypertension, prediabetic, and vitamin D deficiency. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN), erythromycin (MANUFACTURER UNKNOWN), and ciprofloxacin (CIPRO); all for unspecified indications from unknown dates to unknown dates and experienced drug allergy. On 02Jan2021 at 18:00, the patient started having soreness. On 03Jan2021 at 16:45, the patient had nausea. On 03Jan2021, she also had swollen lymph nodes, was tired all day, and ""she just did not feel like herself-like she had the flu"". The patient was not given any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the soreness, nausea, swollen lymph nodes, tiredness, and ""she did not feel like herself-like she had the flu"" were recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Polycystic ovarian syndrome; Pre-diabetic; Prehypertension; Vitamin D deficiency,,,"['Fatigue', 'Influenza like illness', 'Lymphadenopathy', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,OT 936215,CA,55.0,F,"headache; dizziness; fatigue; couldn't sleep; severe abdominal pain; This is a spontaneous report from a contactable healthcare professional (patient herself). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration on the left arm on 29Dec2020 11:30 at single dose for COVID-19 immunisation. Medical history included Addison's disease, papaya allergy, and gluten intolerance. Concomitant medications included hydrocortisone and fludrocortisone acetate (FLORINEF ACETATE). The patient verbalized, ""At first, on 29Dec2020, I experienced only mild side effects such as headache, dizziness and fatigue. Later, I woke up in the middle of the night with severe abdominal pain and couldn't sleep the pain was so bad. I had to take the following day off due to abdominal pain and fatigue."" No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,WRK,; FLORINEF ACETATE,,Medical History/Concurrent Conditions: Addison's disease; Fruit allergy; Gluten intolerance,,,"['Abdominal pain', 'Dizziness', 'Fatigue', 'Headache', 'Insomnia']",1,PFIZER\BIONTECH, 936216,KY,25.0,F,"Fever, chills, nausea, body aches, tachycardia; Fever, chills, nausea, body aches, tachycardia; Fever, chills, nausea, body aches, tachycardia; Fever, chills, nausea, body aches, tachycardia; Fever, chills, nausea, body aches, tachycardia; This is a spontaneous report from a contactable nurse (patient). This 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the right arm on 04Jan2021 08:30 for Covid-19 immunisation. Medical history included Covid-19 on an unknown date. The patient's concomitant medications were not reported. The patient experienced fever, chills, nausea, body aches, tachycardia on 04Jan2021 20:30 with outcome of unknown. Therapeutic measures were taken as a result of fever, chills, nausea, body aches, tachycardia included Tylenol, Ibuprofen, Benadryl. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,,,"Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19)",,,"['Chills', 'Nausea', 'Pain', 'Pyrexia', 'Tachycardia']",1,PFIZER\BIONTECH, 936217,CA,44.0,F,"Patient complained of itching starting on her legs, which went upwards; Redness on her arms, neck, face; Redness on her arms, neck, face; Redness on her arms, neck, face; Itching up to her scalp; Dry cough; Rash; This is a spontaneous report from a contactable nurse (patient). A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the left arm, on 26Dec2020, at 09:00 AM, for COVID-19 immunisation. COVID-19 vaccine was administered at hospital. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included asthma, hypertension, hypothyroidism, penicillin allergy, food allergy (melon and pineapple) and latex allergy. Concomitant medications, received within 2 weeks of vaccination, included omalizumab (XOLAIR), levothyroxine sodium (LEVOXYL), levocetirizine dihydrochloride (XYZAL), losartan and formoterol fumarate, mometasone furoate (DULERA). After covid vaccination, the patient was advised to stay 30 minutes for observation. On 26Dec2020 at 09:15, less than 15 minutes later, the patient complained of itching starting on her legs, which went upwards. The patient took 25 mg oral diphenhydramine hydrochloride (BENADRYL). She noted to have redness on her arms, neck, face, itching up to her scalp. By then she started to have a dry cough, removed her mask, nurse who was with her called for a rapid response team. Patient's epi pen was used, they then started IV and pushed emergency meds and transported to ED. Emergency room/department or urgent care was required. Another dose of epinephrine IM and additional meds were given. Placed on oxygen via non-rebreather with albuterol. Epinephrine drip started. Stabilized after 3 hours, stayed in observation for 12 hours then discharged to home. Around the clock 50 mg diphenhydramine hydrochloride (BENADRYL) at home x 2 days, then levocetirizine (ZYXAL) thrice daily x 7 days to control itching and redness/rash. Other treatment included steroids, pepcid. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19 (PCR, Nasal Swab) on 26Dec2020 and the result was negative. Clinical outcome of the adverse events was recovering at time of this report. Information on the lot/batch number has been requested.; Sender's Comments: Based on a close temporal association, a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/26/2020,0.0,PVT,XOLAIR; LEVOXYL; XYZAL; ; DULERA,,Medical History/Concurrent Conditions: Asthma; Food allergy; Hypertension; Hypothyroidism; Latex allergy; Penicillin allergy,,,"['Cough', 'Erythema', 'Pruritus', 'Rash', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 936218,KS,25.0,F,"tingling reaction on her arms, body/tingling in the hands and arms; swelling of the face; headaches; she had numbness in the face and tingling; weakness in the arms and legs, extremity weakness; fatigue; in the back, she had pain, soreness in the vertebrae in the middle going down; in the back, she had pain, soreness in the vertebrae in the middle going down; she hasn't been able to sleep in a few days, about probably 6 or 7 days.; a bump on her forehead with a high temperature; a bump on her forehead with a high temperature/ it is radiating heat, she feels her forehead hot from that spot; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's father) and a non-contactable consumer (patient's mother) reported that a 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration at the right arm on 21Dec2020 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. After a few days on 25Dec2020, patient started to experience reactions, like a tingling reaction on her arms, body, and also swelling of the face, and she also started to have headaches. It has been like that for a while, and patient who is a health care professional was brought to the emergency room, to check on what was going on, but she was not able to get the medication they need, it was twice that the consumer he tried to bring the patient to emergency, and she still hasn't gotten medication for the symptoms. She started having reactions, she had numbness in the face and tingling, headaches, tingling in the hands and arms, and weakness in the arms and legs, extremity weakness, she felt like fatigue and also in the back, she had pain and soreness in the vertebrae in the middle going down. She has been to emergency 3 times, the last time was yesterday, and so the one thing he needs to report to Pfizer is doctors don't seem to know what to look for, they have no idea, they are looking at other things instead of looking at vaccine side effects, the patient never had problems before the vaccine, but after she started all of these side effects, they need to be looking at what can cause with the vaccine, the first time, yesterday on (03Jan2021) they did a brain MRI because of headache, as they are concerned about nerves in the brain, but a neurologist will see her sometime this month. At this time, they are ruling out things, analyzing the MRI, she did get some medication for pain, and all that stuff since she was suffering with,headache and was sent home last night. Since they said they cannot admit her, as they are afraid she could get COVID 19 in the hospital, but they make sure she is ok, and at this point, all her knows, he hasn't talked to her since last night, and hoping she is sleeping, as she hasn't been able to sleep in a few days, about probably 6 or 7 days. The consumer was wondering, it may be necessary to call the patient directly, to talk more directly to her. The patient also did have on her forehead was a spot in the middle that was raised, kind of like a raised area, from that area, it is radiating heat, she feels her forehead hot from that spot, and they take her temperature with the new handheld touchless thermometer, and it radiates heat like 100.2 to perhaps 100.4 (Dec2020). It always raises a question at these appointments, but then they take her temperature orally and it's 98 degrees (Dec2020). It was also mentioned that the patient was experiencing tingling reaction in the arms, headache, swelling, numbness in her face, and a bump on her forehead with a high temperature. These symptoms were there until yesterday, the Emergency room gave her some medicine, but the consumer hasn't heard from her, his patient was home, they haven't talked since last night. The consumer was hoping she was able to sleep. The consumer stated that the patient was given medicine, it was give to relax her, but it is like a bandaid, not a cure. Now, the consumer stated that the patient said her symptoms were the same symptoms, headache, numbness, everything after last night, she was still with problems. The patient had the very first one, at this point, the consumer doesn't know about the second one, the way she is doing. It was given to all the people she works with, most of the people, the patient works in a hospital, she is a respiratory therapist, it was given to them as they are exposed to all that the COVID 19 in a hospital. Yesterday on 03Jan2021, brain MRI, results showed that the patient was told her that everything looks, initially, looks clear good, but a neurologist will look at the report in detail. and rule out any other conditions, she has to be followed up with by a neurologist, the appointment is pending. The patient's mother asked on behalf of her daughter if this department going to be contacting the doctor for help with resolution about to resolve the health issues, what is to be expected. She added, ""What are people doing when they have these severe side effects, what is Pfizer doing for them, besides taking down information, which is helping Pfizer, what helps the patient resolve side effects from the vaccine?"" The patient's father stated that it seems to them, his daughter went 3 times to Emergency, the first time they said good luck with that, second time, this and that she is ok, go home, and the third time, at least they did a brain MRI, and gave her some medicine, now this morning, she is back to where she was before she went to the ER. He asked, ""Why is there not more documentation, more information provided to doctors that have take care of patients, it seems to be a small group of people with these side effects, and it is really hard, the question they have is, this suffering, why doesn't Pfizer be more active in helping people, now they are investigating that, doing research to him seems like some feedback s not necessarily directed to the patient, as they are trying to take care of themselves, but to call the doctor helping her, to know a better lead to be able to help her, his daughter has missed a lot of work, has a lot of headaches, where is the hope for this to go away? What can Pfizer do to the medical community, to help them?"" Therapeutic measures were taken as a result of headaches. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/01/2020,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Back pain', 'Body temperature', 'Fatigue', 'Feeling hot', 'Headache', 'Hypoaesthesia', 'Insomnia', 'Magnetic resonance imaging brain', 'Muscular weakness', 'Paraesthesia', 'Skin disorder', 'Spinal pain', 'Swelling face']",1,PFIZER\BIONTECH, 936219,,,U,"anaphylaxis; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylaxis on an unspecified date. The outcome of anaphylaxis was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Anaphylactic reaction'],UNK,PFIZER\BIONTECH, 936220,CA,22.0,F,"the injection site is very painful; chills; body aches; swollen lymph nodes; This is a spontaneous report from a contactable other healthcare professional (patient). A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL1284, via an unspecified route of administration in Left arm from 04Jan2021 03:45 to 04Jan2021 03:45 as SINGLE DOSE COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 05Jan2021 04:00 AM, the injection site is very painful, chills, body aches, and swollen lymph nodes (no sore throat). The outcome of the event was unknown. No treatment was received for the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,UNK,,,,,,"['Chills', 'Lymphadenopathy', 'Pain', 'Vaccination site pain']",1,PFIZER\BIONTECH, 936221,MI,49.0,F,"Arm, shoulder, and neck swollen; shoulder and neck swollen; shoulder and neck swollen; Extremely sour; Tender; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 49-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9232) Intramuscular at Left arm on 04Jan2021 08:00 AM at single dose for COVID-19 immunization. Medical history included known allergies to sulfa based antibiotics and a steroid. There are other medications in two weeks. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took ibuprofen and had allergy. Patient experienced arm, shoulder, and neck swollen. Extremely sour and tender on 04Jan2021 11:00 AM. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at workplace clinic. No treatment received for the events. Patient was recovering from the events. It was non serious case. Not results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating nor congenital anomaly/birth defect. Patient was recovering from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Drug allergy; Sulfonamide allergy,,,"['Dysgeusia', 'Joint swelling', 'Peripheral swelling', 'Swelling', 'Tenderness']",UNK,PFIZER\BIONTECH,OT 936222,SC,21.0,F,"Headache; Chest pains; high fever; body aches; chills; first dose 16Dec2020/ second dose 04Jan2021; This is a spontaneous report from a contactable pharmacist (the patient). A 21-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL1284), intramuscularly in the right arm on 04Jan2021 at 12:30 PM (at the age of 21-years-old) as a single dose for COVID-19 immunization. The patient's medical history included COVID-19. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK5730), intramuscularly in the right arm on 16Dec2020 at 11:30 AM (at the age of 21-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 05Jan2021 at 12 AM, the patient experienced chest pains, high fever, chills, body aches, and headache. No treatment was given for chest pains, high fever, chills, body aches, and headache. The clinical outcome of chest pains, high fever, chills, body aches, and headache, was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,,,Medical History/Concurrent Conditions: COVID-19,,,"['Chest pain', 'Chills', 'Headache', 'Inappropriate schedule of product administration', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,OT 936223,MA,49.0,M,"Arm soreness; This is a spontaneous report from a contactable physician. A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number EK9231), via an unspecified route of administration on 19Dec2020 08:00 at single dose at right arm for COVID-19 immunization. Medical history included asthma. Concomitant medications included budesonide (PULMICORT), mometasone furoate (NASONEX), ibuprofen, and paracetamol (TYLENOL). On 20Dec2020, the patient experienced arm soreness. The patient did not receive treatment for the event. The outcome of the event was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/20/2020,1.0,PVT,PULMICORT; NASONEX; ; TYLENOL,,Medical History/Concurrent Conditions: Asthma,,,['Pain in extremity'],1,PFIZER\BIONTECH, 936224,,,F,"itching; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced itching without the presence of rash for 13 to 14 days on an unspecified date. The patient was asking if she should get the second dose of the vaccine if she had itching without the presence of rash for 13 to 14 days after receiving the vaccine. Clinical outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pruritus'],UNK,PFIZER\BIONTECH, 936225,OK,,M,"took first dose of BNT162B2 on 15Dec2020/second dose of BNT162B2 on 04Jan2021; Headache; Fever; Sweats; This is a spontaneous report from a contactable healthcare professional. A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 07:45 at single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication was not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 15Dec2020. The patient experienced fever, sweats, headache on 05Jan2021. The patient received no treatment. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No,,,"['Headache', 'Hyperhidrosis', 'Inappropriate schedule of product administration', 'Pyrexia']",2,PFIZER\BIONTECH, 936226,MO,55.0,F,"Sharp stabbing pains in right rib then left.; Shortness of breathe; cough; eyes swelled shut; This is a spontaneous report from a contactable nurse. This 55-year-old female nurse reported for herself and received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL 3246; Expiration date was not reported) on 30Dec2020 08:45 (at the age of 55-years) as single dose, Intramuscular in left arm for COVID-19 immunisation. Medical history included allergy to hydroxychloroquine sulfate (PLAQUENIL), patient experienced sleep disorder, migraine, and lupus. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications include pregabalin (PREGABALIN), amitriptyline (AMITRIPTYLINE) for sleep, solifenacin succinate (SOLIFENACIN SUCCINATE), leflunomide (LEFLUNOMIDE), omeprazole (PROTONIX), ondansetron (ZOFRAN), mirabegron (MYRBETRIQ), azathioprine (AZATHIOPRINE), and sumatriptan succinate (SUMATRIPTAN SUCCINATE) for migraine. Since the vaccination, the patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 31Dec2020 at 17:15, the patient experienced sharp stabbing pains in right rib then left. Shortness of breathe, cough, and eyes swelled shut. The patient did received treatment as a result of the event with benadryl, aderol inhaler. The outcome of event eyes swelled shut was recovering, Shortness of breathe was recovering, cough was recovering, and sharp stabbing pains in right rib then left was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,; ; ; ; PROTONIX [OMEPRAZOLE]; ZOFRAN [ONDANSETRON]; MYRBETRIQ; ;,,"Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?:Yes); Lupus syndrome; Migraine; Sleep disorder",,,"['Cough', 'Dyspnoea', 'Eye swelling', 'Musculoskeletal chest pain']",1,PFIZER\BIONTECH,OT 936227,AZ,55.0,F,"Hives on stomach and chest 48 hours after; This is a spontaneous report from a contactable other healthcare professional. A 55-year-old female patient received the first dose of bnt162b2 (lot no. and expiry date unknown), intramuscular in left arm on 02Jan2021 16:15 at single dose for Covid-19 immunization. Medical history included mastocytosis. The patient is not pregnant. The patient's concomitant medications were not reported. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 04Jan2021 at 16:00, the patient experienced hives on stomach and chest 48 hours after. No treatment was received for the event. The outcome of the event was recovering. The event was assessed as non-serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/04/2021,2.0,PVT,,,Medical History/Concurrent Conditions: Mastocytosis,,,['Urticaria'],1,PFIZER\BIONTECH,OT 936228,TX,38.0,F,"small bulging rash on injection site that feels warm and is growing larger; small bulging rash on injection site that feels warm and is growing larger; small bulging rash on injection site that feels warm and is growing larger; BNT162B2 first dose was administered on 23Dec2020, second dose was administered on 04Jan2021; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 04Jan2021 09:00 at single dose for Covid-19 immunization. The first dose was administered on 23Dec2020 15:00 via an unspecified route of administration at single dose. The patient's medical history was not reported. No known allergies. Concomitant medication included fluoxetine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced a small bulging rash on injection site that feels warm and is growing larger on 04Jan2021 at 11:45 PM. It was unknown if a treatment has been received for the event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Inappropriate schedule of product administration', 'Rash papular', 'Vaccination site rash', 'Vaccination site warmth']",2,PFIZER\BIONTECH, 936229,PA,54.0,F,"chills; fever, up to 100.9; muscle aches; headache; nausea; diarrhea; This is a spontaneous report from a contactable other HCP (patient). This 54-year-old female reported for herself and received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date were not reported) on 03Jan2021 11:00 (at the age of 54-years) as single dose, Intramuscular left arm for COVID-19 immunisation. Medical history included no allergies to medications, food, or other products and asthma. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications include DOXYCYCLINE (DOXYCYCLINE), METRONIDAZOLE (METRONIDAZOLE), minerals nos, vitamins nos (ONE A DAY) and CALCIUM CARBONATE (CALTRATE). Since the vaccination, the patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 03Jan2021 at 03:30 AM the patient experienced fever, up to 100.9, muscle aches, headache, nausea, diarrhea, chills. Events lasted about 24 hours. The patient did not received treatment as a result of the events. Lab data included body temperature up to 100.9 on 03Jan2021. The outcome of event chills was recovered, fever, up to 100.9 was recovered, muscle aches was recovered, headache was recovered, nausea was recovered and diarrhea was recovered all on Jan2021. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,PVT,; ; CALTRATE [CALCIUM CARBONATE]; ONE A DAY [MINERALS NOS;VITAMINS NOS],,Medical History/Concurrent Conditions: Asthma,,,"['Body temperature', 'Chills', 'Diarrhoea', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,OT 936230,NY,,M,"He had very sore muscle aches the next morning; This is a spontaneous report from a contactable consumer. An adult male patient started to received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 2020 at a single dose, for covid-19 immunization. Medical history included covid-19. The patient's concomitant medications were not reported. The patient stated that he had very sore muscle aches the next morning (2020). The outcome of event was recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,['Myalgia'],1,PFIZER\BIONTECH, 936231,NY,58.0,F,"tested positive for COVID-19; tested positive for COVID-19; loss of taste and smell; loss of taste and smell; excruciating headache; runny nose; congestion; shortness of breath when she started talking; having aches and pains; lightheaded, experienced dizziness; tied; This is a spontaneous report from a contactable consumer(patient). The 58-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, intramuscular injection ), intramuscularly in left arm on 23Dec2020 at single dose for COVID-19 vaccination in nursing home. Medical history included she had a right knee injury so she had some inflammation, She had stomach issues in the past- Barrett's syndrome, H. pylori(Helicobacter infection), GERD(Gastrooesophageal reflux disease), so, Pantoprazole is just a maintenance medicine, she was stable right now. She had a Vitamin D deficiency at one point. Ongoing concomitant medication included meloxicam for inflammation, thyroid for thyroid(Thyroid disorder), pantoprazole for stomach issues, colecalciferol (VITAMIN D 3) for supplementation therapy. There was no vaccination within 4 weeks. She received her first vaccine on 23Dec2020. There no other vaccine received in the same day. By 26Dec2020, she started with symptoms and then she tested positive for COVID-19 on 29Dec2020. She felt horrible with an excruciating headache and was wondering if she was going to die now. She can really feel for the residents she works with who get it. Right now, she was hopefully going back to work next week, but she was wondering about the second vaccine. People are saying she got COVID-19 because of receiving the first vaccine and she was hoping it was not the case. Is it going to be an issue getting the second vaccine after testing positive? The caller declines to include her healthcare professional for this report, stating she has been talking with her doctors over the week. Her symptoms included runny nose, congestion, and what seemed like shortness of breath when she started talking. She started having aches and pains over the weekend. By Monday, 28Dec2020, there was loss of taste and smell, it was totally gone. She also was lightheaded, experienced dizziness, was tied. She went through a lot of symptoms which was shocking to her. She clarified these symptoms first began the morning of the 26Dec2020. Christmas she was fine, and then she to go out to get snow off of her car and do some running around on 26Dec2020 and she noticed she started having symptoms. When probed for outcome, the caller state she was most definitely feeling better. She was having some excruciating headaches and she has worked with her doctor on what they needed to do. She is still working with the doctor on her lightheadedness. She has set up a follow-up appointment, but she was feeling better. There was no emergency room nor physician office. Relevant test was none. It was also reported lot number was either EJ1685 or EJ1085, she can't tell. Outcome of loss of taste and smell was recovered, of dizziness was not recovered, of other events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/01/2020,,OTH,; ; ; VITAMIN D 3,,"Medical History/Concurrent Conditions: Barrett's oesophagitis; GERD; Helicobacter infection; Inflammation; Knee injury (She had a right knee injury so she has some inflammation); Stomach discomfort (She has had stomach issues in the past- Barrett's syndrome, H. pylori, GERD); Thyroid disorder; Vitamin D deficiency",,,"['Ageusia', 'Anosmia', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Headache', 'Impaired work ability', 'Pain', 'Respiratory tract congestion', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 936232,FL,,F,"itching at injection site; half of my face was swollen (right side); Chalazion on my right eye; This is a spontaneous report from a non-contactable consumer. A 71-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose at 10am: she felt okay, no issue. The next day, she had itching at injection site that was on and off not continuous, and that evening after dinner she walked past a mirror and noticed that half of her face was swollen (right side), not a lot swollen, but enough where she could tell it was swollen. The swelling was not going away and she called my internist, and the internist wanted the patient to see someone. The patient went down to the street to a neighbor who was a dermatologist and she looked at the patient and saw that the patient had a Chalazion on right eye and thought the swelling could be from applying heat to the chalazion. The patient called her Internist and told her to take Benadryl and put her on antibiotic; The dermatologist didn't know if it was from the chalazion or a reaction to the vaccine. The patient's lymph nodes were fine and glands were fine. No mass found by the dermatologist yesterday. The dermatologist recommended the patient to see another doctor, if it doesn't go away and to get imaged. The outcome of the event itching was unknown while the outcome of the remaining events was not recovered. No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Chalazion', 'Swelling face', 'Vaccination site pruritus']",1,PFIZER\BIONTECH, 936233,PA,,U,"tingling and numbness to left arm/leg; tingling and numbness to left arm/leg; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was still having tingling and numbness to left arm/leg. The outcome of the events was not recovered. Information about lot/batch number requested",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,PVT,,,,,,"['Hypoaesthesia', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 936234,MS,27.0,M,"Began to feel really cold; Muscle pains; Joint pains; Throbbing headache; Fever of 101.7F; Shivering chills; Second dose of BNT162b2 was given 17 days after 1st dose; This is a spontaneous report from a contactable physician, the patient. A 27-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 04Jan2021 11:15 AM (at the age of 27-years) as a single dose (Lot Number EK9231) for COVID-19 immunization. Medical history included asthma and no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 via an unspecified route of administration in the left arm on 18Dec2020 12:00 PM (at the age of 27-years) as a single dose (Lot Number EH9899) for COVID-19 immunization. The patient had not received any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 04Jan2021, approximately 10-12 hours after 2nd dose of vaccine the patient began to feel really cold, had some mild muscle pains, joint pains, and a headache. Overnight these symptoms worsened to severe muscle pains, joint pains, and a throbbing headache, shivering chills, took a temperature and had a fever of 101.7F. These symptoms did not subside until late the next morning. The headache had persisted. The patient reported taking paracetamol (TYLENOL) 1000 mg, which helped. The outcome of the events feels really cold, muscle pains, joint pains, throbbing headache, shivering chills, fever of 101.7F, were reported as recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Asthma,,,"['Arthralgia', 'Body temperature', 'Chills', 'Feeling cold', 'Headache', 'Inappropriate schedule of product administration', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH, 936235,PA,53.0,F,"nausea; Headache; insomnia; This is a spontaneous report from a contactable healthcare professional. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 30Dec2020 14:00 at a single dose for COVID-19 immunisation. Medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. There were no allergies to medications, food, or other products. Concomitant medications included vitamin b complex (VITAMIN B), colecalciferol (VITAMIN D [COLECALCIFEROL]), and zinc. On 31Dec2020, the patient experienced nausea, headache and insomnia. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovering Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,VITAMIN B; VITAMIN D [COLECALCIFEROL];,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Headache', 'Insomnia', 'Nausea']",UNK,PFIZER\BIONTECH,OT 936236,AL,20.0,F,"dizziness; Nausea; fast heart rate; This is a spontaneous report from a contactable other healthcare professional. A 20-year-old female patient received the first dose of bnt162b2 (lot number: EK9251), intramuscular in left arm on 04Jan2021 13:00 at single dose for covid-19 immunization. Medical history included COVID-19. Concomitant medication included ethinylestradiol, norgestimate (MONO LINYAH). The patient previously took ciprofloxacin (CIPRO) and experienced drug allergy. The patient is not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. The patient experienced dizziness, nausea, and fast heart rate on 05Jan2021. Since the vaccination, the patient has been tested for COVID-19 which included nasal swab test on 05Jan2021: negative. The outcome of the events was unknown. The events were reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,MONO LINYAH,,Medical History/Concurrent Conditions: COVID-19,,,"['Dizziness', 'Heart rate', 'Heart rate increased', 'Nausea', 'SARS-CoV-2 antibody test']",1,PFIZER\BIONTECH,OT 936237,,65.0,F,"headache; chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, chills, and nausea on an unspecified date. The patient asked if she is going to get the same reaction on the second dose. The outcome of events was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,,,UNK,,,,,,"['Chills', 'Headache', 'Nausea']",1,PFIZER\BIONTECH, 936238,NY,48.0,F,"itching; irritation; hives/they are welty feeling and looking; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, from 02Jan2021 16:45 to 02Jan2021 16:45 at 0.3 mL, single for covid-19 immunization. Medical history reported as ""none"". There were no concomitant medications. The patient noticed hives on the back of her legs this morning 05Jan2021. She has taken oral Benadryl which took all the itching and irritation away but the hives are still there. Further described as ""they are welty feeling and looking"". She added that she was not scheduled for the second injection yet, they told her to wait for an email to arrive for her to set it up. She has informed her primary HCP of her hives. Outcome of events itching and irritation was recovered whereas the patient had not recovered from hives at the time of this report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/05/2021,3.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Pruritus', 'Skin irritation', 'Urticaria']",1,PFIZER\BIONTECH, 936239,PA,67.0,M,"tested positive for COVID virus; tested positive for COVID virus; cold all day; tiny cough; chills; sweating/ woke up sweating wet; arm pain/Very sore arms; body aches; fever; some muscle aches; This is a spontaneous report from a contactable consumer(Patient's Wife). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 02Jan2021 13:30 at single dose for COVID-19 vaccination. There were no concomitant medications nor medical history. He did not receive any other vaccines that day or 4 weeks prior. No history of any other vaccines or events. He got his vaccine on Saturday(02Jan2021) at 1:30pm(13:30) and by 5:30pm(17:30) had very sore arms/arm pain, at 7:30pm(19:30) he had chills off and on and was sweating. He woke up soaking wet and did that on Sunday, but was feeling a little better today. He also experienced body aches and fever in Jan2021. Today is testing day at his work and he tested positive for COVID virus on 05Jan2021. Not sure if it's a coincidence. Again, he got the shot and then started having all these symptoms at 5:30 and 7:30. Now they are both on quarantine for the 10-14 days. He wanted to see if it's possible to test positive for the virus after getting the shot or is it just a coincidence. He also had some muscle aches in Jan2021. Last night (04Jan2021), he woke up again sweating, but not like on Saturday, but he got really warm and started to sweat a little, and on Sunday(03Jan2021) he was cold all day and had a tiny cough, but it wasn't significant. Ever so often she would hear him cough. All of a sudden patient would wake up sweating. Again, Saturday he soaked everything. There was no Emergency Room nor Physician Office. Outcome of Very sore arms, sweating was recovering, of pain and fever was unknown, of other events was not recovered. Information on Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Cough', 'Feeling cold', 'Feeling hot', 'Hyperhidrosis', 'Myalgia', 'Night sweats', 'Pain', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 936240,DE,38.0,F,"diarrhea; headache; fever with 100.4; joint and neck pain; joint and neck pain; heart rate racing (higher than normal); intense nausea; pain in stomach; vomiting; chills; This is a spontaneous report from a contactable Other HCP(patient). The 38-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), via an unspecified route of administration in deltoid left on 04Jan2021 12:00 at single dose for COVID-19 vaccination. Medical history included covid-19 from Oct2020 to Nov2020 for five weeks , ongoing depression, ongoing anxiety. Ongoing concomitant medication included escitalopram oxalate (LEXAPRO) for depression, clonazepam (KLONOPIN) for anxiety. The patient experienced heart rate racing on 05Jan2021 with outcome of recovering , intense nausea on 04Jan2021 23:00 with outcome of recovering , pain in stomach on 04Jan2021 23:00 with outcome of recovering , vomiting on 04Jan2021 with outcome of recovering , chills on 04Jan2021 with outcome of unknown , fever with 100.4 on 05Jan2021 with outcome of unknown , joint and neck pain on 05Jan2021 with outcome of not recovered, headache on 05Jan2021 02:00 with outcome of not recovered , diarrhea on 05Jan2021 05:30 with outcome of unknown. It was reported she got her first dose yesterday (04Jan2021) and she was concerned with the side effects she is experiencing because they were so severe. She got the COVID Vaccine around 12:00. After getting the vaccine she felt fine and then went to bed. However, after around 11 pm she woke up from bed with intense nausea and pain in her stomach. She got up and started vomiting. She could not stand up right due to the pain. The nausea was so intense she had to crawl on the floor. She also had chills and had to bundle up in bed. She checked her temperature and she had a fever. She also had joint and neck pain. She also had a headache. She took some Tylenol. She later started to feel like she was sick again, but she did not vomit again. She later felt like her heart was racing. She could not go back to sleep because her heart rate was higher than normal. Then this morning she had diarrhea. She stated she has called out of work due to this. She explained in regards to the chills she took Tylenol and it is still in her system. She does not know if it will come back or not. She clarified the fever she had her temperature was 100.4 on 05Jan2021 and it went down with Tylenol. It went down to 99.5. The joint and neck pain started around the same time in the middle of the night around midnight. The headache started around two in the morning. Her heart rate racing started around midnight. As of now her heart rate had decreased, but it was not back to her normal rate. She had a Pulse Ox and she can keep track of her heart rate. Normally her heart rate is 48 beats per minute. Her heart rate went up to 95 beats per minute. The diarrhea started around 05:30 this morning. She has had no more episodes since 07:30. She had a total of two episodes. There was no Emergency Room or Physician's Office needed. There was no prior vaccinations within 4 weeks. Therapeutic measures(Tylenol) were taken as a result of chills , fever with 100.4, joint and neck pain, headache (headache). Events were assessed as non-serious by the reporter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,LEXAPRO; KLONOPIN,Anxiety; Depression,Medical History/Concurrent Conditions: COVID-19 (for five weeks.),,,"['Abdominal pain upper', 'Arthralgia', 'Body temperature', 'Chills', 'Diarrhoea', 'Headache', 'Heart rate', 'Heart rate increased', 'Nausea', 'Neck pain', 'Pyrexia', 'SARS-CoV-2 test', 'Vomiting']",1,PFIZER\BIONTECH, 936241,TX,38.0,M,"site injection pain; muscle in arm pain; tiredness; foggy head; Chest muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 04Jan2021 15:15 (at the age of 38-years) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included lisinopril and gabapentin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin and experienced allergies. On 05Jan2021 04:15, the patient experienced injection site pain, muscle pain in arm, tiredness, foggy head, chest muscle pain. The patient did not receive any treatment for the events. Since vaccination, the patient had not been tested for COVID-19. The outcome of the events injection site pain, muscle pain in arm, tiredness, foggy head, chest muscle pain, was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,;,,,,,"['Fatigue', 'Feeling abnormal', 'Musculoskeletal chest pain', 'Myalgia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 936242,DE,57.0,F,"itching in hands and feet which progressed to back, neck and head/ later stated her head as well; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: 5K5730) via an unspecified route of administration in the upper right arm on 19Dec2020 11:00 at a single dose for covid-19 immunisation. Medical history included asthma in 1996, allergies to penicillin, high blood pressure, reflux, allergies, and broke her leg 17 years ago in 2003. The patient has no prior vaccinations within 4 weeks. Concomitant medications included unspecified medications for high blood pressure, reflux, and allergies. The patient previously had allergies with morphine (manifestation: holding hands over ears and felt everyone was screaming at her) and vancomycin. The patient got first dose on 19Dec2020 and is supposed to go back Saturday (09Jan2021) for follow up dose. She wanted to verify if she should get it. After the first injection, it was uneventful the day she got it, and then 4-5 days later, she got itching in hands and feet. It was not so alarming. She still has it and then it started progressing to her back and neck and later stated her head as well. It is not all the time just intermittent. She needed to take Benadryl to keep from scratching so much. Yesterday seemed to be worse. She did not have any hives. Around the end of last week is when it spread to other places besides hands and feet. She doesn't have itching today on back, but she does on her hands and feet. The outcome of the event was not recovered. No ER or physician's office required. She does take daily maintenance medications and she does not know if they are relevant. She also takes medication for high blood pressure, reflux and allergies. She was taking all of them before she took this.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/01/2020,,PVT,,,Medical History/Concurrent Conditions: Acid reflux (esophageal); Asthma; Blood pressure high; Broken leg (17 years ago); Drug allergy; Penicillin allergy,,,['Pruritus'],1,PFIZER\BIONTECH, 936243,PA,61.0,F,"fever; nausea; general feeling of unwell; soreness at site; redness; whole upper arm was swollen after the injection; This is a spontaneous report from a contactable other HCP (patient, Respiratory Therapist) reported that a 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , Batch/lot number: EJ1685) via an unspecified route of administration on 21Dec2020 around 6:00 PM in left upper arm at 0.3mL single dose for COVID Prevention. The patient's medical history was covid at the end of Apr/May2020 with shortness of breath, seasonal allergies and allergies to ""some anitbiotics."" The concomitant medications was reported as none, received no other vaccines on the same day as the COVID vaccine. The patient experienced soreness at site, redness and swelling, fever, nausea, general feeling of unwell 3 days. Patient stated, ""I had covid at the end of April/May with shortness of breath. I thought I would have less reaction from the vaccine. I know someone who was out of work for a while week after the vaccine."" States that she read that the 2nd dose is supposed to have worse side effects than the first. If she had bad side effects from the 1st dose, will the 2nd be worse? Also asking if the side effects are the immune system reacting or just an allergic reaction. Patient was anxious about getting her second COVID shot on 11Jan2021. Patient stated that she had all the side effects listed, for three days. Patient stated that she didn't mind the side effects at the time, she had fever, soreness at the injection site, nausea, and a general feeling of unwell, but Patient stated that she could not work like that. Patient stated that her question was, statistically she has read that the side effects from the second shot are supposed to be worse than the first shot, but she was wondering, if she had bad side effects from the first shot, will her side effects be worse after the second, or will they maybe be lessened because she already had bad side effects. Patient reported that she did fill out the VSafe significant because she had to work on the third day after her shot, which was Christmas Eve, and work, was so busy and she did not feel well. Patient stated that she does have two days scheduled off work after her next injection, but it is the third day that she was worried about because she does not want to work feeling like that. Patient stated that the arm soreness started that same day (21Dec2020). At first, Patient reported that the arm soreness resolved, but then she states that it is still a little sore to the touch. So Patient confirmed that it is ongoing but improved. Patient reportsed that the fever started the day after the injection, 22Dec2020 and it has resolved. Patient reported that the last day she recorded a fever was on 24Dec2020. Patient stated that she woke up on 24Dec2020 and her temperature was normal, so she went to work and she did not feel so well at work, but they were so busy that she barely noticed, and then when the Patient went home that night, she took her temperature and it was 100 degrees Fahrenheit. Patient reported that the nausea started on 22Dec2020, which was mild at times, but then she got to where she did not want to eat. Patient reported that the nausea has resolved but she was not entirely sure when it resolved because she had been so busy at work on 24Dec2020, and it was hard to tell what she was feeling because she was non-stop busy that day. Patient stated that she was nauseous for a full three days, and she remembered that she did not eat much on the 24th either. So Patient stated that her nausea may have resolved on the third day after her injection, but it is unknown to her what day exactly that it resolved. Patient was also experiencing the general feeling of unwell from 22Dec2020 for a few days, but stated that by 25Dec2020 she felt okay. Patient also included that her left arm was also swollen, like her whole upper arm was swollen after the injection in Dec2020. Patient stated that she also experienced redness, there was a like a red mark that was further down her arm than the injection site in Dec2020. The outcome of soreness at site was recovering. Patient confirmed that both the swelling and redness had resolved in Dec2020.The outcome of fever was recovered on 24Dec2020. The outcome of general feeling of unwell and nausea was recovered on 25Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: COVID-19 (the end of Apr/May2020 with shortness of breath); Drug allergy; Seasonal allergy,,,"['Body temperature', 'Erythema', 'Malaise', 'Nausea', 'Peripheral swelling', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 936244,VA,,F,"a little bit of a cough.; headache; runny nose; Aside from her taste and smell still being gone; Aside from her taste and smell still being gone/loss of taste; fogginess; Patient had since tested positive; Patient had since tested positive; patient likely had exposure on 22Dec2020; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient likely had exposure on 22Dec2020. She showed the first covid symptoms on 31Dec2020. Patient experienced loss of taste, headache, fogginess, runny nose, and a little bit of a cough on unspecified date. Patient received her first covid dose on 21Dec2020. The first dose likely helped her, she has rapidly gotten better and was feeling much better today. Aside from her taste and smell still being gone. The patient was scheduled to receive her second dose on 11Jan2021. Patient had since tested positive. Caller clarified that the patient didn't get a test until 03Jan2021. Outcome of events taste and smell still being gone was not recovered, and outcome of other events was unknown. Information on batch/lot number was requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 Nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/22/2020,1.0,UNK,,,,,,"['Ageusia', 'Anosmia', 'Cough', 'Exposure to SARS-CoV-2', 'Feeling abnormal', 'Headache', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 936245,,,F,"tested positive; tested positive; runny nose; headache; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer reported that a 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive, runny nose, headache after getting the vaccine on an unspecified date with outcome of unknown. This report is considered as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Headache', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 936246,TX,31.0,F,"a red looking rash that's itchy; a red looking rash that's itchy; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL0140 and expiry date: Mar2021, via an unspecified route of administration in left arm from 23Dec2020 to 23Dec2020 as single dose (first dose) for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient stated she noticed the day after getting the COVID vaccine, 24Dec2020 that morning when she woke up between 9am to 10am that she had this red looking rash that it is itchy. The person who gave her the shot placed a band-aid on the site of injection. At first caller thought the person who gave her the injection missed the site where it was injected where placing the band-aid. However, this was a big red circle. The circle was bigger than a quarter. It is still itchy. This is located on her left arm. She stated she was hoping it would just go away on its own. No additional details provided. She is due to receive the second dose on 13Jan2021 or 14Jan2021 depending on when there is availability. The patient is about 130 pounds give or take. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/24/2020,1.0,PVT,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient's Medical History: None",,,"['Rash erythematous', 'Rash pruritic', 'Weight']",1,PFIZER\BIONTECH, 936247,AZ,29.0,M,"Headache is gradually getting worse; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 04Jan2021, at a single dose, COVID-19 immunization. The patient had no medical history and concomitant medications. The patient works in a laboratory. The patient has had no issues with vaccines in the past. The patient got the vaccine yesterday (04Jan2021) and is wondering what to do with the headache side effects. The patient received his first dose yesterday and the headache was noticed today (05Jan2021) at 5 or 6 AM. The patient's headache is gradually getting worse. The patient wanted to confirm if this is a documented side effect. The patient was informed that Pfizer cannot provide any medical advice. The patient was provided a card when he got the vaccine. The patient has never taken any COVID or antibody tests prior to the vaccine. The patient had not recovered from the event. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Headache'],1,PFIZER\BIONTECH, 936248,IN,32.0,F,"Headache behind my eyesTiredness; Headache behind my eyesTiredness; This is a spontaneous report from a contactable healthcare professional. A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 12:00 at single dose for covid-19 immunisation. Medical history included gastrooesophageal reflux disease and known allergies: Penicillin. Concomitant medication included omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and oxymetazoline hydrochloride (CLARITIN ALLERGIC). The patient has known allergies: Codeine. The patient stated, ""headache behind my eyes tiredness"", on 04Jan2021 12:15, The outcome of the events was recovering. Information lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,PRILOSEC [OMEPRAZOLE MAGNESIUM]; CLARITIN ALLERGIC,,Medical History/Concurrent Conditions: GERD; Penicillin allergy,,,"['Fatigue', 'Headache']",1,PFIZER\BIONTECH, 936249,LA,,F,"arm pain, concern is the injection site; a swollen injection site a size of a quarter with heat 13 hours later; she has swelling at the injection site and heat underneath it; BNT162B2 first dose was administered on 16Dec2020, second dose was administered on 04Jan2021; joint pain; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), first dose on 16Dec2020 between 12:30 and 1:30 via an unspecified route of administration at single dose, then the second dose on 04Jan2021 via an unspecified route of administration at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the first vaccine on the 16Dec2020 between 12:30 and 1:30 and had symptoms 12 to 13 hours post injection. She had joint pain which is normal. Two or three weeks later she had the second vaccine. It was given yesterday (04Jan2021) around the same time as the first one was given. About 13 hours later she had arm pain. She didn't feel anything until 2AM when she started feeling achiness. Her concern is the injection site. She doesn't know if it will get infected. The patient added that she had experienced arm pain, a swollen injection site a ""size of a quarter"" with heat 13 hours later. She also stated that she did not experience this with the first shot and is asking if this normal for the 2nd shot. She knows it is listed as part of the side effects, but she has swelling at the injection site and heat underneath it. The patient asked, ""Is that normal to sustain for about 12 hours? It started around 2am"". She took three Tylenol and that seemed to help. The outcome of events was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/01/2020,,UNK,,,,,,"['Arthralgia', 'Inappropriate schedule of product administration', 'Vaccination site pain', 'Vaccination site swelling', 'Vaccination site warmth']",1,PFIZER\BIONTECH, 936250,GA,63.0,F,"Blood Pressure shot up to 170/100. took 3 hours to return to normal.; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231), via an unspecified route of administration in the left arm on 05Jan2021 07:00 at a single dose for covid-19 immunization. Medical history included arthritis, allergy to plants and arthropod sting. the patient was not pregnant at the time of the reporting. The patient's concomitant medications were not reported. On 05Jan2021 07:00, the patient's blood pressure shoot up to 170/100. It took 3 hours to return to normal. The outcome of event was recovered. No treatment was required/given due to the event. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Allergic reaction to wasp sting; Allergy to plants; Arthritis,,,"['Blood pressure increased', 'Blood pressure measurement']",1,PFIZER\BIONTECH, 936251,MI,65.0,F,"non stop diarrhea; nausea; chills; joint pain; sore at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 02Jan2021 07:30 at single dose for covid-19 immunization. The patient's medical history was none, and there were no concomitant medications. The first dose patient received on 02Jan2021 morning, and she just had symptoms she expected, she was sore at the injection site and she had some joint pain on 03Jan2021, but those disappeared on 04Jan2021. On 05Jan2021, she woke up and had non stop diarrhea with a little bit of nausea. Patient had not had a fever, but did feel chilled. Patient didn't think she ate anything bad. She was suspecting this may be a side effect of the vaccine. Patient didn't have a prescribing doctor. She got it at the hospital she worked at. She received it the 02Jan2021 7:30 am. Patient started the diarrhea on 05Jan2021 morning at 8:30. The nausea was on and off, but started this morning as well. Patient didn't take any ongoing medication. Outcome of events sore at the injection site and joint pain was recovered on 04Jan2021, outcome of event diarrhea was not recovered, and outcome of events nausea, and chills was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Arthralgia', 'Chills', 'Diarrhoea', 'Nausea', 'Vaccination site pain']",1,PFIZER\BIONTECH, 936252,,70.0,F,"fever of 105F; chills; severe headache; arm pain; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable healthcare professional (HCP). A 70 year-old female patient (pregnancy information not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on 18Dec2020 (at the age of 70 years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to receiving the vaccination it was not reported if the patient had been tested for COVID-10. It was also not known if she received any other vaccinations in 4 weeks or other medications in past 2 weeks. On 18Dec2020, the patient received the first dose of the COVID-19 vaccine and had arm pain that lasted for a few hours at that time. Seventeen days post first vaccination (approximately 04Jan2021), she developed a fever of 105F, chills and severe headache which have now resolved. She wanted to know if she should get the second vaccine in series given her side effects. it was not reported if the patient was hospitalized or treated for the events.The clinical outcome of the events of arm pain, fever of 105F, chills and severe headache was recovered on an unspecified date. It was not reported if the patient was tested for COVID-19 after receiving the vaccination. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,01/01/2021,14.0,UNK,,,,,,"['Body temperature', 'Chills', 'Headache', 'Pyrexia', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 936253,FL,40.0,F,"shortness of breath; tightness in her chest; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number: EL0140, expiry date: 19 Vaccine: Mar2021, via an unspecified route of administration in the left arm from 29Dec2020 16:00 to 29Dec2020 16:00 as SINGLE DOSE for COVID-19 immunisation. Medical history included blood pressure abnormal (She has been on blood pressure med for 3 years). Concomitant medication included labetalol oral 200 mg, 2x/day for Blood pressure. The patient reports since Sunday night, 03Jan2021, she noticed feeling a little tightness in her chest and shortness of breath but her O2 saturation is fine. Reports she tested it at 98% to 97%. Asking is this a side effect of the vaccine, has it been reported? Does it have anything to do with the expected effectiveness after a week of getting the first dose? She is scheduled for the second dose 18Jan2021. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure abnormal (She has been on blood pressure med for 3 years),,,"['Chest discomfort', 'Dyspnoea', 'Oxygen saturation']",1,PFIZER\BIONTECH, 936254,OH,55.0,F,"tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program Pfizer First Connect. A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration in the right arm on 18Dec2020 at single dose for covid 19 immunisation as healthcare professional and husband was high risk. Medical history included hypertension from 2019 and ongoing. Concomitant medication included amlodipine besilate (NORVASC, 5 mg) from 2019 and ongoing for high blood pressure. The patient experienced tested positive for covid-19 on 03Jan2021 with outcome of not recovered, congestion and headache in Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID test on 03Jan2021 and the results came back positive on 04Jan2021. The patient was scheduled to receive her second injection on 08Jan2021. Since her first injection she had tested positive for COVID-19. The second dose had to be given a certain amount of days after the first. She would be outside that window. She would like to know if there is any guidance regarding the if/when she should get the second dose. The reporter would like to know if she waits longer than the recommended 21 days to receive her second dose of the COVID-19 vaccine would she need to restart the vaccination series. The reporter said this was not serious as she only had congestion and headache with treatment: using over the counter stuff. Event relatedness with COVID vaccine was unknown.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 vaccine cannot be completely excluded for reported ""tested positive for COVID-19"".",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,01/03/2021,16.0,UNK,NORVASC,Blood pressure high,,,,"['Headache', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 936255,IL,50.0,F,"Shoulder pain and aches a lot; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 19Dec2020 at 10:30, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient wasn't diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Dec2020, the patient experienced shoulder pain and aches a lot. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered with lasting effects (sequel) from the event on an unspecified date. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/19/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Arthralgia'],1,PFIZER\BIONTECH, 936256,,36.0,F,"it was like having Covid again; it was like having Covid again; body aches; dry mouth; generalized weakness; temp was 38.1 Celsius; head feels weird; can't sleep; decreased appetite; pain at the injection site; This is a spontaneous report from a contactable Nurse (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. Medical history included COVID-19 from Mar2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced body aches, dry mouth, can't sleep, generalized weakness, decreased appetite, and pain at the injection site, temp was 38.1 Celsius, head feels weird in Jan2021. The patient got her first dose and was looking online to see the symptoms. She said that she saw that during the trials, people were experiencing the symptoms she was experiencing after the second dose and she was concerned. She said that she wanted to make sure her symptoms are ok and to make sure that the symptoms are not just caused from the booster, but also from the first dose. The caller said that her mom told her that someone died from the Pfizer vaccine. No further details provided. The patient was having body aches, could not sleep, her mouth is really dry, her temp was 38.1 Celsius, her head feels weird, she has generalized weakness, pain at the injection site, and decreased appetite. She said that it was like having Covid again. She said that she had Covid back in Mar2020. The patient underwent lab tests and procedures which included body temperature: 38.1 centigrade. The outcome of all the events was unknown. The events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the suspected COVID likely represents a pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 Nucleic acid/ PCR test is needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: COVID-19 (She said that she had Covid back in Mar2020.),,,"['Asthenia', 'Body temperature increased', 'Decreased appetite', 'Dry mouth', 'Head discomfort', 'Injection site pain', 'Insomnia', 'Pain']",1,PFIZER\BIONTECH, 936257,,,F,"hives all over her body; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 29Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced hives all over her body on 02Jan2021 with outcome of unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/02/2021,4.0,UNK,,,,,,['Urticaria'],UNK,PFIZER\BIONTECH, 936258,PA,55.0,F,"Itching; neck rash; cough; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 27Dec2020 08:15 at a single dose for COVID-19 immunisation. Medical history included hypertension and allergies from IVP dye, sulfa, and iodine. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Concomitant medications included hydrochlorothiazide (HCTZ), lisinopril, and calcium carbonate (CALTRATE). On 27Dec2020 08:30, the patient experienced itching, neck rash and cough. The patient underwent lab tests and procedures which included investigation: unknown results (Pending) on 02Jan2021. Therapeutic measure was taken as a result of the events that included Benadryl. Clinical outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/27/2020,0.0,PVT,HCTZ; ; CALTRATE [CALCIUM CARBONATE],,Medical History/Concurrent Conditions: Contrast media allergy; Hypertension; Iodine allergy; Sulfonamide allergy,,,"['Cough', 'Investigation', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH,OT 936259,IN,38.0,F,"Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak; Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak; Jaw/neck/throat area became tight like tensing up; Hard to talk, was shouting out one word at a time; My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms; My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms; My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms; My fingers move often, like a compulsion; This is a spontaneous report from a contactable health care professional, the patient (patient). A 38-years-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), intramuscular in the left arm on 28Dec2020 19:00 as a single dose, for COVID-19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital The patient had no known medical history or allergies. Concomitant medication included bupropion (BUPROPION), propranolol (PROPRANOLOL), sertraline (SERTRALINE), ethinylestradiol, levonorgestrel (PORTIA 21). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 28DEC2020, the patient experienced Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak. Jaw/neck/throat area became tight like tensing up. Hard to talk, was shouting out one word at a time. My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms. My fingers move often, like a compulsion. Adverse event resulted in a physician office visit. No treatment was given for the event. The clinical outcome of Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak. Jaw/neck/throat area became tight like tensing up. Hard to talk, was shouting out one word at a time. My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms. My fingers move often, like a compulsion was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,; ; ; PORTIA 21,,,,,"['Fatigue', 'Limb discomfort', 'Muscle spasms', 'Muscle tightness', 'Muscular weakness', 'Pain', 'Paraesthesia', 'Speech disorder']",1,PFIZER\BIONTECH,OT 936260,NY,,F,"HCP put her on low taper dose steroid -mederol to minimize swelling; This is a follow up spontaneous report from a contactable other health professional (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose on 21Dec2020, and she will be receiving 2nd dose of vaccine this coming Monday (11Jan2021). She had oral surgery yesterday on 05Jan2021, the surgery was already planned prior to first dose of vaccine. HCP (health professional) put her on low taper dose steroid, mederol to minimize swelling. The patient asked if there was any reason to continue to take her steroid medication and if is it ok to continue to take. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,,,UNK,,,,,,['Swelling'],1,PFIZER\BIONTECH, 936261,IN,29.0,F,"she is pregnant as well; she reported to be diagnosed positive for COVID last 01Jan2021 after showing symptoms on 31Dec2020; she reported to be diagnosed positive for COVID last 01Jan2021 after showing symptoms on 31Dec2020/tested positive for COVID-19; This is spontaneous report from a contactable Other Health Professional (patient) via a Pfizer Sponsored Program. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1685), intramuscularly in right deltoid on 23Dec2020 14:30 at single dose for COVID-19 vaccination while pregnant. Medical history was none. Concomitant medication included ongoing ascorbic acid, betacarotene, calcium carbonate, colecalciferol, docosahexaenoic acid, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, vitamin b12 nos, zinc oxide (PRENATAL MULTIVITAMIN + DHA, Prenatal Multi + DHA), one soft gel, every morning as prenatal medication. The reporter was asking for recommendations for her in taking the second dose as she reported to be diagnosed positive for COVID last 01Jan2021 after showing symptoms on 31Dec2020. She received the first dose of the vaccine last 23Dec2020. She is asking if she should wait 90 days before taking the 2nd dose. Agent has a physical therapist on the phone. She had her first dose of the COVID vaccine on 23Dec2020. She started to show symptoms of COVID on 31Dec2020. She tested positive on 01Jan2020. Caller wants to know does she need to wait 90 days for the second dose. Caller wanted to add she is pregnant as well. She declined to include a healthcare professional for the report. The caller states she started to feel symptoms towards the end of the day on 31Dec2020. She clarifies she felt like she was having a cold coming on. She had some congestion. When probed for outcome, caller stated it had improved quite a bit. She had been improved but today, its kind of like she had a cold again, but that had improved. Vaccination Facility Type: Hospital. Vaccine Administered at Military Facility: No. Prior Vaccinations (within 4 weeks): None within 4 weeks. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Relevant Tests: None. Investigation Assessment: Yes. Is a sample of the product available to be returned, if requested (Y/N): Vaccine was administered in hospital. No AE required a visit to emergency room and physician office. The reporter stated her symptoms have been pretty mild. The patient underwent lab tests and procedures which included COVID Fast-acting (rapid) test: positive on 01Jan2021. Outcome of events was recovering.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 cannot be completely excluded",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/01/2021,9.0,PVT,PRENATAL MULTIVITAMIN + DHA,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'Exposure during pregnancy', 'Nasopharyngitis', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 936262,PA,,F,"She did a rapid antigen test and was positive; She did a rapid antigen test and was positive; her arm hurt after vaccination; she lost taste; This is a spontaneous report from a contactable Consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Friend shared that the patient's arm hurt after vaccination and the following day she lost taste. She did a rapid antigen test and was positive. Adverse event start date was 04Jan2021. No treatment was received for the adverse event. AE resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Test name: antigen (positive). Outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Ageusia', 'Pain in extremity', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 936263,NY,,F,"being exposed to someone who is positive for covid; head cold; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated, ""calls to ask if she is able to get the second dose of the vaccine after being exposed to someone who is positive for covid. Caller reports that she received the first dose of the vaccine on 18Dec and is scheduled to get her second dose on 08Jan. Since her first dose her son and husband have been found positive for covid and she was tested today, no result back yet. She requests information about vaccination following exposure reporting that when she asked her work place they said they didn't have any information about it. Caller also reports that she is experiencing a ""head cold"" this week but states ""it's not from the vaccine"". The outcome of the events were unknown. Information on the lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,,,UNK,,,,,,"['Exposure to SARS-CoV-2', 'Nasopharyngitis']",1,PFIZER\BIONTECH, 936264,,,F,"Received the Pfizer COVID-19 on 21Dec2020. I got Covid from a family member, sore throat, felt like a flu or bad cold,headache, body aches and sinus issue. She now has congestion and cough; Received the Pfizer COVID-19 on 21Dec2020. I got Covid from a family member, sore throat, felt like a flu or bad cold,headache, body aches and sinus issue. She now has congestion and cough; This is a spontaneous report from a contactable health care professional nurse, the patient. A female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 21Dec2020 as a single dose for COVID-19 vaccination. The patient had no known medical history. The patients concomitant medications were not reported. On an unspecified date the patient experienced I got Covid from a family member. She reported being symptomatic on 1Jan2021 started with a sore throat, felt like a flu or bad cold. She reported sore throat, headache, body aches and sinus issue. She now has congestion and cough. She had no issue when she got the vaccine. The patient will be getting the second dose 11Jan2021 and she would like to know if she is eligible to receive the second dose Pfizer Covid-19 Vaccine. The clinical outcome of the event was unknown . Information on the Lot number has been requested.; Sender's Comments: The reported ""got COVID from a family member"" after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,,,UNK,,,,,,"['COVID-19', 'Cough', 'Exposure to SARS-CoV-2', 'Headache', 'Influenza like illness', 'Nasopharyngitis', 'Oropharyngeal pain', 'Pain', 'Respiratory tract congestion', 'Sinus disorder']",1,PFIZER\BIONTECH, 936265,LA,36.0,F,"is pregnant: yes; Extremely sore arm; body aches; headache; This is a spontaneous report from a contactable other health professional (patient). This reporter reported information for both mother and fetus/baby. This is a maternal report. A 36-year-old female patient (pregnant) receive first dose of BNT162B2, via an unspecified route of administration on 04Jan2021 16:45 in right arm at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient experienced extremely sore arm, body aches, headache on 04Jan2021. The adverse event was not resulted in emergency room visit and physician office visit. The events were reported as non-serious. No treatment received for the adverse event. The mother reported she became pregnant while taking bnt162b2. Last menstrual date was 12Jun2020. The mother was 29 weeks pregnant at the onset of the event. The mother was due to deliver on 19Mar2021. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient wasn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks: Prenatal vitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Allergies to medications, food, or other products was no. The outcome of events was resolving. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS,,,,,"['Headache', 'Maternal exposure during pregnancy', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 936266,CA,65.0,F,"received the vaccine on December 17th and tested positive for Covid on December 27th/COVID PCR (polymerase chain reaction) test: positive on 28Dec2020; received the vaccine on December 17th and tested positive for Covid on December 27th/COVID PCR (polymerase chain reaction) test: positive on 28Dec2020; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable nurse (patient) reported that a 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 17Dec2020 11:00 in left deltoid at single dose for covid-19 immunization. Medical history included thyroid cancer from an unknown date and unknown if ongoing, bilateral thyroidectomy in 2014. Family Medical History: Father died of lung cancer. Mother died of cardiac arrest in 1972. Concomitant medication included levothyroxine sodium (SYNTHROID) for bilateral thyroidectomy. The patient received the vaccine on 17Dec2020 and tested positive for covid on 27Dec2020. The adverse events resulted in emergency room visit. The patient underwent lab tests and procedures which included tested positive for COVID on 27Dec2020, COVID PCR (polymerase chain reaction) test: positive on 28Dec2020. Vaccination facility type was hospital. No additional vaccines administered on same date of Pfizer suspect. Received COVID Vaccine on 17Dec2020. Tested positive for COVID in emergency room on 27Dec2020. Tested positive on a COVID PCR test on 28Dec2020. Prior vaccinations within 4 weeks was none. Caller received the first dose of the COVID Vaccine. Tested positive for COVID on 27Dec2020. Is about to get the second dose of COVID Vaccine and would like to know if she should proceed or wait. Since quarantine, she has had no fever. Is slightly short of breath and has a headache. Works in COVID units in a hospital. Wants to make sure she can receive the second dose. Stated she had no adverse reaction to the COVID Vaccine unless an adverse reaction can occur two weeks after. Is attributing the shortness of breath and headache to testing positive for COVID. Shortness of breath and headache only occurred after testing positive for COVID. Reason she went to the hospital is because she lost her sense of smell. She got tested and was positive for COVID. Lost sense of smell, went to Emergency Room, and notified doctor of positive test the following day, 28Dec2020. Clarified she just went to the emergency department to get tested for COVID and then went home. Was called with positive results in an hour. Caller wanted to know when she should proceed with getting her second dose of Covid vaccine. She is supposed to receive her second dose tomorrow. She thought she was going to take second dose when I completely recovered. Caller asked if she waited until the 13th to receive second dose of Covid vaccine, would it be effective. She would feel more comfortable doing that. The outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID-19 based on the known safety profile. However the short duration of 9 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/27/2020,10.0,PVT,SYNTHROID,,Medical History/Concurrent Conditions: Thyroid cancer; Thyroidectomy (Bilateral thyroidectomy in 2014),,,"['Anosmia', 'Dyspnoea', 'Headache', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 936267,AL,48.0,F,"hard lumps at filler sites above upper lip and under left eye - filler injected 7 months prior to vaccine; hard lumps at filler sites above upper lip and under left eye - filler injected 7 months prior to vaccine; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # ekj5730), intramuscular at single dose in the right arm on 28Dec2020 13:00 for COVID-19 immunisation. Medical history included migraine, allergies to Codeine, Hydrocodone. Concomitant medications were not reported. On 29Dec2020 11:00, the patient experienced hard lumps at filler sites above upper lip and under left eye - filler injected 7 months prior to vaccine. The outcome of the events was not recovered. No treatment was performed. The patient was not pregnant at the time of vaccination. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Migraine,,,"['Eye disorder', 'Lip disorder']",1,PFIZER\BIONTECH,OT 936268,OK,44.0,M,"pain in both big toes, severe pain in the left big toe; acute gouty attack; acute gouty attack; This is a spontaneous report from a contactable physician (patient). A 44-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular (left arm) on 17Dec2020 15:30 at single dose for Covid-19 immunization. Patient's medical history included gout and shellfish allergy. Concomitant medications included magnesium glycinate (MAGNESIUM GLYCINATE), colecalciferol (VITAMIN D), and finasteride. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported he got his vaccine on 17Dec2020, a week later on 03Jan2021 (04:30 PM) he started having some pain in both big toes and then 3 days ago, he had severe pain in the left big toe with what appears to be acute gouty attack. The patient reported he has a history of gout previously but had controlled it for a long time. There were no other changes that happened. The patient was treated with ibuprofen and colchicine. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,01/03/2021,17.0,PVT,; VITAMIN D;,,Medical History/Concurrent Conditions: Gout (Previous history of gout); Shellfish allergy (known allergies: Shell fish),,,"['Condition aggravated', 'Gout', 'Pain in extremity']",1,PFIZER\BIONTECH,OT 936269,PA,30.0,M,"Felt like he couldn't breath; He still has his sense of taste, but it is dulled; Recently got the vaccine and also came down with covid; Recently got the vaccine and also came down with covid; Exhaustion/feeling tired; Loss of smell; Mild congestion/The congestion went into full nasal drainage; This is a spontaneous report from a contactable pharmacist (patient). A 30-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140, Expiry Date: 31Mar2021), via an unspecified route of administration on 31Dec2020 13:00 at single dose for Covid-19 immunization. The patient had no relevant medical history and concomitant drug. The patient experienced recently got the vaccine and also came down with covid on 04Jan2021 00:30, mild congestion/the congestion went into full nasal drainage on 31Dec2020, loss of smell on 02Jan2021, exhaustion/feeling tired on 03Jan2021, felt like he couldn't breathe, he still has his sense of taste, but it is dulled on an unspecified date. He was a pharmacist. He received his first dose of the COVID vaccine on Thursday 31Dec2020 1pm. Shortly thereafter, he got the typical side effects of the vaccine that are posted. Then 2.5 days letter he no longer had a sense of smell. Everything he read said that he probably came in contact with COVID prior to administration. His questions was since he test positive for COVID, should he still get the second shot. He got it at a clinic. He did experience mild congestion which started by 6 o'clock. He started to notice slight congestion that kind of went away. Then, on Friday, about 24 hours later, he really noticed he had congestion. He took pseudoephedrine hydrochloride (SUDAFED) and paracetamol (TYLENOL). Then his sense of smell diminished with the congestion and felt like he couldn't breathe. On Saturday, he decided to not take medication. That was when he noticed he could not smell anything. He had full blown congestion. It probably took two days when he started to lose his sense of smell. He received the shot on Thursday. On Saturday, he lost his sense of smell. He still has his sense of taste, but it was dulled. Sunday, he was just exhausted and feeling tired. These were all listed as typical side effects except for the loss of smell. Saturday was the worst. The congestion went into full nasal drainage. On Sunday he had no sinus issues. He still hasn't gained his sense of smell back. The exhaustion set in Sunday 03Jan2020. He doesn't feel like any of the side effects are serious. The exhaustion has started to let up some so it is improving. He was pretty much back to normal. He just couldn't figure out why he had a loss of smell. He had a COVID rapid test on 04Jan2021 at 8:30 am (as reported). He received an alert and hour later that it was positive. He was wondering whether the loss of smell could be from the vaccine. The patient underwent lab tests and procedures which included COVID-19 rapid POC test: positive on 04Jan2021. The outcome of events for mild congestion/the congestion went into full nasal drainage was resolved on 03Jan2021, for loss of smell was not resolved, for exhaustion/feeling tired was resolving, for other events was unknown. The events were reported as non-serious.; Sender's Comments: Reported event ""recently got the vaccine and also came down with covid"" is considered possibly related to suspect BNT162B2 based on temporal association and known drug safety profile.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Anosmia', 'COVID-19', 'Dyspnoea', 'Fatigue', 'Hypogeusia', 'Respiratory tract congestion', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 936270,,,F,"mild runny nose; This is a spontaneous report from a Pfizer-sponsored program. A contactable 34-year-old female nurse, who is also the patient, reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced mild runny nose. The patient reported also that her son was just diagnosed with COVID and she just took a test on an unspecified date but was negative. She was still experiencing a mild runny nose. At the time of the report, the patient had not recovered from the mild runny nose whereas the outcome of the exposure to COVID-19 was unknown. The Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/07/2020,,,UNK,,,,,,"['Rhinorrhoea', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 936271,AZ,51.0,F,"sneezing; coughing; congestion; fever; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration in left arm (triceps muscle) on 30Dec2020 10:30 at single dose for covid-19 immunization. Medical history included seasonal allergy from 1995 and ongoing, seasonal asthma from 1995 and ongoing. The patient had no concomitant medications. The patient experienced fever on 31Dec2020, congestion on 02Jan2021, sneezing and coughing on an unspecified date. Time the vaccination was given around 10:30 a.m, but she known she was okay to leave by 10:45 a.m. No additional administered vaccines. The adverse event was not required a visit to emergency room or physician office. Prior Vaccinations (within 4 weeks) was none. Relevant tests were none. Certified nursing assistant works in hospital where she cares for Covid patients. She received the vaccine on 30Dec2020 and by the next day, she had fever and congestion. The fever has gone away but she was still congested and was sneezing and coughing at home. The caller stated she was a CNA calling on behalf of herself in regard to the Pfizer COVID vaccination. She stated she received the vaccine on 30Dec2020. She had like a fever and everything over the weekend- starting Thursday night, Friday and then part of Saturday. She also had this congestion ever since she got the shot. The caller confirmed she received her first COVID vaccine on 30Dec2020. Late Thursday night, 31Dec2020, she woke up and had a fever. She had her husband check her temperature. She confirmed she recovered completely from the fever. She hadn't a fever since Saturday (02Jan2021), probably around 8pm. She didn't have a fever at all on Sunday. The congestion really didn't start until Saturday morning, 02Jan2021. She stated the congestion was still persisting at this point. Caller stated, "" it honestly feels like a sinus infection"" The caller was able to provide the Lot number off of her patient card. Caller made the comment the card also had the date she had to go back for her second vaccine. The patient underwent lab tests and procedures which included body temperature: recovered completely from the fever. The outcome of events for fever was resolved on 02Jan2021, for congestion was not resolved, for other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,,Seasonal allergy; Seasonal asthma,,,,"['Body temperature', 'Cough', 'Nasal congestion', 'Pyrexia', 'Sneezing']",1,PFIZER\BIONTECH, 936272,,,M,"Doctor had the 1st dose last 16Dec2020 then tested positive for COVID 17Dec2020; Doctor had the 1st dose last 16Dec2020 then tested positive for COVID 17Dec2020; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect, received from a contactable physician (patient). A male patient of an unspecified age started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), unspecified route of administration on 16Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician inquired ""is it recommended to receive the 2nd dose despite having antibodies and recovered from COVID?"" The doctor had the 1st dose on 16Dec2020 then tested positive for COVID 17Dec2020. He will receive the 2nd dose tomorrow 06Jan2021 and he was recovering. The patient underwent lab tests and procedures which included COVID test: result positive on 17Dec2020. Outcome of the event doctor had the 1st dose last 16Dec2020 then tested positive for COVID 17Dec2020 was recovering. Information on the lot/batch number has been requested.; Sender's Comments: The reported tested positive for COVID after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/17/2020,1.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 936273,CA,63.0,F,"I felt ok right after the injection but about 2 hours later I started experiencing a pressure headache, gradually felt very poorly and took a nap for a few hours. Upon waking I felt ok but after walk; weakness; felt very poorly; This is a spontaneous report from a contactable other health care professional. A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL1284), intramuscular on 04Jan2021 11:45 at single dose at left arm for COVID-19 immunization. Medical history included hypothyroidism, psoriasis. Concomitant medications included etanercept (ENBREL), and levothyroxine. The patient felt okay right after the injection but about 2 hours later, on 04Jan2021 14:30, she started experiencing a pressure headache, gradually felt very poorly and took a nap for a few hours. Upon waking the patient felt okay but after walking around the house for about 20 minutes, the headache started up again and the same awful feeling of weakness so she laid down and took another 2 hours nap. When the patient woke up the second time she felt as though nothing had happened, was feeling fine. So the patient would say the side effects lasted for about 5 hours. The outcome of the events was recovered on 04Jan2021 17:00.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,ENBREL;,,Medical History/Concurrent Conditions: Hypothyroidism; Psoriasis,,,"['Asthenia', 'Feeling abnormal', 'Headache']",1,PFIZER\BIONTECH,OT 936274,NC,57.0,M,"He received the first dose of the Covid-19 Vaccine on 18Dec2020/ received the second dose of Covid-19 vaccine 04Jan2021; he experienced fever 102.5F; muscle and joint pain; muscle and joint pain; it hurts to raise his arms above his head; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient (Weight (kg): 79.38, height (cm): 170) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140, Expiry Date: Mar2021), intramuscularly in upper left arm on 04Jan2021 13:00 for covid-19 prophylaxis. The patient had no relevant medical history and concomitant medications. Prior vaccinations (within 4 weeks) was none, relevant tests was none. The patient previous received first dose of Covid-19 Vaccine on 18Dec2020 and had no side effects, received flu vaccine in Oct2020 for immunization. The patient experienced fever 102.5f, muscle and joint pain, it hurts to raise his arms above his head all on 05Jan2021 01:00. The event was not required a visit to emergency room or physician office. The patient underwent lab tests and procedures which included fever: 102.5 F on 05Jan2021. Vaccination Facility Type was hospital. Caller stated that he worked at a hospital, but he was not a doctor, nurse, or pharmacist. The caller said that he received the second dose of Covid-19 vaccine 04Jan2021 and 12 hours after receiving the vaccine he started running a fever of 102.5. He said that he got the second dose at 13:00 and started feeling the fever symptoms about 12 hours later at about 01:00 05Jan2021. His vaccination was done at the hospital. He said that with his first dose he had no side effects. He received the first dose of the Covid-19 Vaccine on 18Dec2020. He said that he had his flu vaccine in Oct2020. Caller also reported that he was having muscle and joint pain. He said that it hurts to raise his arms above his head. He let his employee health know about the symptoms he was experiencing. Caller wanted to know if his side effects are normal, especially the ""mild - moderate"". The outcome of events was not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Body temperature', 'Inappropriate schedule of product administration', 'Myalgia', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,OT 936275,,,M,"he received his first dose of the vaccine on 22Dec2020 and tested positive for Covid yesterday (04Jan2021).; he received his first dose of the vaccine on 22Dec2020 and tested positive for Covid yesterday (04Jan2021).; This is a spontaneous report from a contactable other healthcare professional (patient). A male patient of an unspecified age started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), unspecified route of administration on 22Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He received his first dose of the vaccine on 22Dec2020 and tested positive for COVID yesterday (04Jan2021). He stated his ""symptoms were general at first, then weakness after 10 days, chilly and muscle strain"". The other HCP reported ""do I need to take the second dose on 11Jan2021?"" The patient underwent lab tests and procedures which included COVID test: result positive on 04Jan2021. Outcome of the event he received his first dose of the vaccine on 22Dec2020 and tested positive for COVID yesterday (04Jan2021) was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported positive test for Covid after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,01/04/2021,13.0,UNK,,,,,,"['Asthenia', 'Feeling cold', 'General symptom', 'Muscle strain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 936276,AZ,47.0,F,"she had COVID symptoms; she had COVID symptoms; chills; low grade fever; muscle joint pain; muscle joint pain; exhausted with a headache/ She doesn't want to get up she is tired; exhausted with a headache/slight headache; muscle joint pain which is a stabbing pain all over her body; feeling unwell; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, manufacturer: Pfizer), via an unspecified route of administration on 04Jan2021 14:00 at single dose for Covid-19 immunization. Medical history included ongoing childhood asthma, COVID 19 positive from 07Dec2020 to an unknown date. There were no concomitant medications. The patient felt like she had covid symptoms, chills, low grade fever, muscle joint pain, exhausted with a headache/ she doesn't want to get up she was tired, muscle joint pain, which was a stabbing pain all over her body, feeling unwell, all on 05Jan2021 05:00. The events were reported as non-serious. Caller had Sars-COV-2 infection diagnosed 07Dec2020. Received first dose of vaccine 04Jan2021 at 14:00. She was experiencing chills, low grade fever, muscle joint pain, exhausted with a headache. Asking for information on efficacy of second dose. She didn't have any side effects or anything initially. Then, 12 hours later at 5- 6 am she felt like she had COVID symptoms. She already had COVID so she known what it feels like. She was wondering how long would last. It was almost like having real COVID. She didn't have a prescribing doctor. She had COVID 07Dec2020. She was currently experiencing Chills, fever low grade, muscle joint pain which was a stabbing pain all over her body, and she was feeling unwell. She didn't want to get up she was tired. She has a slight headache. This all started at 5 am on 05Jan2021. Even with medication. She has been taking paracetamol (TYLENOL) and excedrin. She cannot work if she wanted to, but these effects are not serious. Her fever has went down. The chills have stayed the same. She was diagnosed with childhood asthma. Caller asked about interval information between the SARS-COV-2 infection diagnosed 07Dec2020 and her first dose of vaccine 04Jan2021 at 14:00. The outcome of events for felt like she had covid symptoms was unknown, for low grade fever was resolving, for other events was not resolved.; Sender's Comments: There is not a reasonable possibility that event suspected COVID-19 is related to BNT162B2. There is no test done to confirm whether patient got COVID-19 or not. And symptoms that were suspected by reporter as due to COVID-19 occurred one after the vaccination, when vaccine was not expected to achieve the effect.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,UNK,,Childhood asthma,Medical History/Concurrent Conditions: COVID-19 virus test positive,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Impaired work ability', 'Malaise', 'Myalgia', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 936277,MD,43.0,F,"a lot of tingling/numbness in my hand on the injection side; a lot of tingling/numbness in my hand on the injection side; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date not reported), via an unspecified route of administration on the left arm on 05Jan2021 10:45 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient previously took clarithromycin (BIAXIN) and experienced allergies. The patient verbalized, ""I don't believe it's anything serious but I am experiencing a lot of tingling/numbness in my hand on the injection side"" on 05Jan2021 11:30. Clinical outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH, 936278,PA,21.0,F,"lost all motion and feeling in her right arm/no feeling in right arm or hand/no feeling in her fingers; developed a horrible rash; problems breathing; flu-like symptoms; fever; body aches; vomiting; diarrhea; still really painful at injection site; chills; This is a spontaneous report from a contactable nurse (patient herself). A 21-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1686/PF2), via an unspecified route of administration in right arm on 02Jan2021 13:15 at single dose for COVID-19 immunization. The patient's medical history were not reported. Allergies to medications, food, or other products was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. Facility type vaccine was workplace clinic. Caller reported to have taken the vaccine last Saturday (02Jan2021 13:15) and 2 hours (02Jan2021 15:15) after had experienced vomiting and then an hour later (02Jan2021 14:15) 3 times with diarrhea. She also experienced flu-like symptoms which included fever, body aches, problems breathing and chills later that evening. On Sunday morning (03Jan2021), patient woke up with no feeling in right arm or hand. She lost all motion and feeling in her right arm and developed a horrible rash. The rash and other symptoms have been resolved but she still has no feeling in her fingers as of the moment. Doctor on call said to rest and take paracetamol (TYLENOL) every 4 to 6 hours. Patient had feeling in arm started to come back but still really painful at injection site and still had no feeling in fingers or thumb. The patient underwent lab tests and procedures which included nasal Swab: pending results on 04Jan2021. Events result in doctor or other healthcare professional office/clinic visit. All events were reported as non-serious. Outcome of lost all motion and feeling in her right arm/no feeling in right arm or hand/no feeling in her fingers, painful at injection site was not recovered and outcome of other events were recovered in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,WRK,,,,,,"['Chills', 'Diarrhoea', 'Dyspnoea', 'Hypoaesthesia', 'Influenza like illness', 'Pain', 'Pyrexia', 'Rash', 'Smear test', 'Vaccination site pain', 'Vomiting']",UNK,PFIZER\BIONTECH, 936279,LA,73.0,M,"he tested positive for COVID; he tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) from a contactable physician (patient). A 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the right deltoid on 28Dec2020 09:30 at single dose for COVID-19 immunization. Medical history included diabetic (he is a diabetic, but he is not on medication for it) from Nov2018 and ongoing, hepatitis (not ongoing) (He had hepatitis virus for 15 to 20 years. It resolved 5 or 6 years ago. It corrected on it's own), supplement, hypertension and carcinoma of the lung. Everyone in his family has hypertension. His sister had carcinoma of the lung. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not have additional vaccines administered on same date of the Pfizer suspect. There were no prior vaccinations within 4 weeks. There were no adverse events following prior vaccinations. Concomitant medication included doxazosin mesilate (CARDURA), bisoprolol fumarate, hydrochlorothiazide (ZIAC), nystatin (STATIN) taken for lipids, colecalciferol (VITAMIN D) taken for supplement, fish oil, acetylsalicylic acid (BABY ASPIRIN), vitamin C [ascorbic acid]. The patient also received multivitamin. He has been on all concomitant medications for at least three to four years. The patient was scheduled for the next dose on 18Jan2021. On 05Jan2021 he tested positive for COVID. The event was reported as serious as medically significant. The patient was given the antibody infusion and steroid injection. It was outpatient. He was not admitted. Treatment was received for the events. The outcome of the events was unknown. Information on lot number/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. However individuals may not be protected until at least 7 days after their second dose of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,PVT,CARDURA; ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]; STATIN [NYSTATIN]; VITAMIN D [COLECALCIFEROL]; ; BABY ASPIRIN; VITAMIN C [ASCORBIC ACID],"Diabetic (he is a diabetic, but he is not on medication for it.)",Medical History/Concurrent Conditions: Hepatitis (He had hepatitis virus for 15 to 20 years. It resolved 5 or 6 years ago. It corrected on it's own.); Hypertension (Everyone in his family has hypertension); Lung cancer (His sister); Supplementation therapy,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 936281,IN,61.0,F,"Soreness and swelling at injection site; Soreness and swelling at injection site; Malaise; feels tired; This is a spontaneous report from a Pfizer-sponsored program. A contactable other HCP (Patient) reported for a 61-year-old female patient received the first dose of BNT162b2 (lot: EK92331), intramuscular at left arm on 04Jan2021 (approximately between 18:15-18:30) at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications included supplements. The patient experienced soreness and swelling at injection site, malaise and feels tired on 05Jan2021 08:00. She was scheduled for second dose a day later for COVID vaccine so after the 21 days to get her second dose. Patient is a Dental Hygienist. She received the first dose on 04Jan2021 and is scheduled to receive second dose on 26Jan2021. She should have it scheduled for 25Jan2021. There is no prescriber. She received it at a local hospital through her employer. They did not offer her the 25Jan2020, and said next day is 26 days. They told her there would not be any problem being a day late. She called back with a concern and had evening appointment with the intention of being 3 weeks later. She did it while she had 2 days off work in case she had a reaction. She was told it was not a big deal to get it 1 days later. She asked if she could go to a different location and they told her no, it had to come from the same batch and lot to receive second dose. She is just concerned about doing it a day before she has to go back to work because there are worse side effects with second dose. There is a 4 day grace period from what she read of of 17-21 days and not over 21 days. She is not sure if that is true though. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Fatigue', 'Malaise', 'Vaccination site pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH,OT 936282,,,F,"About 1 hour later, her left side of her face, her lips and tongue were numb. She says ""it did get better but it is still numb""; About 1 hour later, her left side of her face, her lips and tongue were numb. She says ""it did get better but it is still numb""; About 1 hour later, her left side of her face, her lips and tongue were numb"". She says ""it did get better but it is still numb""; left leg is really hurting; This is a spontaneous report from a contactable consumer (patient). This female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 03Jan2021 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that after receiving vaccine, ""about 1 hour later, her left side of her face, her lips and tongue were numb"". She says ""it did get better but it is still numb"". She added that her ""left leg is really hurting"". It hurts when she touches it. The outcome of her left side of her face, her lips and tongue were numb was recovering and outcome of left leg is really hurting was unknown. The patient would like to know if she should receive the 2nd dose? Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/01/2021,,UNK,,,,,,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Pain in extremity']",1,PFIZER\BIONTECH, 936283,,,F,"following the receipt of the first dose of the COVID-19 vaccine; testing positive to COVID; This is a spontaneous report from a non-contactable other Healthcare Professional reported for herself. A female patient of an unspecified age (Age: 47, Unit: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient explained testing positive to COVID on the 29Dec2020, following the receipt of the first dose of the COVID-19 vaccine on the 20Dec2020. She stated that minor symptoms remain, and asked if she could receive the second dose of the vaccine due on the 10Jan2021. The outcome of the events was not reported. No follow-up attempts are possible; information about lot/ batch number cannot be obtained.; Sender's Comments: The reported testing positive to COVID after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/29/2020,9.0,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 936284,TN,28.0,F,"Flu-like symptoms; Cold symptoms; tested positive for SARS-COV-2 infection; tested positive for SARS-COV-2 infection; muscle and body aches; muscle and body aches; loss sense of taste; Congestion nasal; Sore throat; Loss of smell; Sinus pressure; Headache; general fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EJ1685, via an unspecified route of administration on 17Dec2020 16:00 at single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient got the COVID Vaccine and the day after, was exposed to the virus, got sick right away and tested positive for the virus. The patient stated that she got vaccinated around 4pm, 17Dec2020. She was exposed to the virus by the same coworker twice on 18Dec2020 and then the next week, she believed, on 22Dec2020, the coworker tested positive for COVID. Patient stated that her symptoms started 24Dec2020. She did not think she had a fever as she did not feel feverish. She had flu like symptoms from an unspecified date with muscle and body aches from 25Dec2020. She lost her sense of taste and smell from 25Dec2020. She had cold-like symptoms from an unspecified date with congestion nasal and sore throat from 25Dec2020, sinus pressure and headaches from 24Dec2020. She had general fatigue from 24Dec2020 for a while. Patient had not had another COVID test since the one she had 28Dec2020, when she tested positive for COVID. She became symptoms-free on 03Jan2021. Patient was asking should she still get the 2nd dose of the COVID Vaccine. She was also concerned about the reaction her body was going to have to the vaccine after being sick. The patient had recovered from Flu-like symptoms and Cold symptoms on an unspecified date, recovered from muscle and body aches on 29Dec2020, recovered from loss sense of taste and loss of smell on 31Dec2020, recovered from congestion nasal, sinus pressure and headache on 03Jan2021, recovered from Sore throat on 01Jan2021, recovered from general fatigue on 02Jan2021. And outcome of ""tested positive for COVID after receiving the COVID Vaccine"" was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/24/2020,7.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Ageusia', 'Anosmia', 'Fatigue', 'Headache', 'Influenza like illness', 'Malaise', 'Myalgia', 'Nasal congestion', 'Nasopharyngitis', 'Occupational exposure to SARS-CoV-2', 'Oropharyngeal pain', 'Pain', 'Paranasal sinus discomfort', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 936285,,,M,"He received the 1st dose of the vaccine on Friday 18DEC2020. He developed COVID the following Thursday.; He received the 1st dose of the vaccine on Friday 18DEC2020. He developed COVID the following Thursday.; This is a spontaneous report from a contactable Physician (patient's wife). A 55-year-old male patient received the 1st dose of bnt162b2 (BNT162B2) on 18Dec2020 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced developed Covid on 24Dec2020 (reported as the following Thursday). The patient underwent lab tests and procedures which included Sars-Cov-2 test: developed Covid. He was fairly symptomatic for 7 days but he was doing well now. The outcome of events was recovering. The reporter quereide whether he should receive the 2nd dose, which is due on 08Jan2021 or should it be deferred. Information on Lot/Batch number requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported positive Sars-Cov-2 test, which is considered ineffective of BNT162B2, and the administration of BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/24/2020,6.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 936286,OK,55.0,F,"began having Covid symptoms on 24Dec and tested positive for Covid on Christmas; began having Covid symptoms on 24Dec and tested positive for Covid on Christmas; Arm was sore; This is a spontaneous report from a contactable physician reported for herself. A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 vaccination. Medical history was not reported. There were no concomitant medications. Patient had arm sore on 18Dec2020. She started having COVID symptoms on 24Dec2020. She tested positive on Christmas, 25Dec2020. She was asking if she should get the second vaccine. When she got the vaccine she didn't pay attention to the paperwork. She was busy. Her arm was a little sore for a day that was the only reaction she had. She was hoping when she developed COVID symptoms that she was not sick. She was not hospitalized, and she is wondering if maybe the vaccine helped her not get as sick, and not end up in the hospital. It was the first dose she received. She has no other medical conditions. All the previous agent did was read off information to her. It sounds to her like she should go ahead and get the second dose. Outcome of event Arm was sore was recovered in 19Dec2020, of others was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be completely excluded for reported events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,UNK,,,,,,"['Adverse event', 'Pain in extremity', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 936287,OR,,F,"allergic reaction to the vaccine; golf sized swelling at the injection site; This is a spontaneous report from a contactable nurse for self. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on arm on an unspecified date at single dose for COVID-19 vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. She just got her first Pfizer COVID vaccine 11 days ago. She immediately got a golf ball sized swelling at the injection site. She had no other reaction. No systemic reaction. Her arm has lasted until now, but it is definitely better. She is not warred about that any more. She specified that the swelling remained the same size for five days and improved. She then explained that she saw her doctor as she thought that it was infected, but the doctor said that it was an allergic reaction to the vaccine. She then asked if she should receive the second dose of the vaccine, and if her reaction is considered severe. Outcome of event was recovering. No follow up attempts are possible. Information about Batch/Lot number can not be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Hypersensitivity', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 936288,,,U,"developed covid like symptoms a few days later/ tested positive on the 26th; developed covid like symptoms a few days later/tested positive on the 26th; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 18Dec2020 and developed covid like symptoms a few days later in Dec2020 and believed the patient was likely exposed. The patient was tested positive on 26Dec2020. The outcome of the events was unknown. Information about Lot/Batch number has been requested.; Sender's Comments: The reported covid like symptoms a few days with tested positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/01/2020,,UNK,,,,,,"['Adverse event', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 936289,CA,37.0,F,"body aches; pounding head; low-grade fever; doesn't feel fine; ""horrible"" muscle aches particularly around the low hip area but also ""all over""; feeling dizzy; elevated BP 155/100; This is a spontaneous report from a contactable consumer for self. A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), Intramuscular in Right upper arm on 04Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included seasonal asthma as a kid and as she got older, it got worse. There were no concomitant medications. She reports the following AE's: ""horrible"" muscle aches particularly around the low hip area but also ""all over"", feeling dizzy, elevated BP 155/100 in Jan2021, ""pounding head"", low-grade fever, body aches 05Jan2021. She received the first COVID vaccine on 16Dec2020 and then the second vaccine yesterday. Now, she doesn't feel fine. The caller clarifies further with the first vaccine, she was fine. She had a sore arm and that's it. With this second vaccine, she doesn't feel fine. She didn't start feeling bad until around 1 a.m. She received the second vaccine yesterday, 04Jan2021. Around 1 a.m., she started feeling not so hot. She confirms she started to experience body aches, making the comment "" it's ridiculous, it's my entire body"". Also, a headache and low-grade fever. She states these symptoms didn't get really bad or worse until 10 this morning. Outcome of event feeling unwell was recovered on 05Jan2021, of headache, low-grade fever, body aches, was not recovered, of others was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/01/2021,,PVT,,,Medical History/Concurrent Conditions: Seasonal asthma,,,"['Blood pressure increased', 'Blood pressure measurement', 'Dizziness', 'Headache', 'Malaise', 'Myalgia', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,OT 936290,MD,29.0,F,"she is having a hard time sleeping; swelling; She developed a knot on the side of her neck that was very painful; She does not know if it is a swollen lymph node; right arm pain; pain started traveling up her neck to the shoulder area.; pain started traveling up her neck to the shoulder area; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscular on 24Dec2020 08:30 at the first single dose for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient received vaccine in Right arm. She got the Pfizer Covid19 vaccine on 24Dec2020. The right arm pain started two hours after getting the vaccine and the arm pain got progressively worse and the pain started traveling up her neck to the shoulder area on 24Dec2020. The patient experiencing Right neck pain and swelling on 26Dec2020. She developed a knot on the side of her neck that was very painful, along with arm pain that went up to her neck on 26Dec2020. The knot developed about 2 days after she got the vaccine and now the knot is getting larger. She does not know if it is a swollen lymph node but she has never had a swollen lymph node in that area, states it is above her collar bone and the knot is very painful. She is thinking to go to urgent care since it is bothering her to where she is having a hard time sleeping. On 26Dec2020 she noticed it was painful in the particular spot where she found the knot. Her arm pain went away by the 27Dec2020 and it was not too painful any more, she clarifies her arm pain recovered completely as of 27Dec2020. The painful knot has gotten worse. The patient did not receive any treatment for the events. The outcome of event right arm pain was recovered on 27Dec2020; outcome of event knot on the side of her neck was not recovered; outcome of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Insomnia', 'Lymphadenopathy', 'Mass', 'Neck pain', 'Pain in extremity', 'Swelling']",1,PFIZER\BIONTECH,OT 936291,FL,65.0,F,"Sporadic itching in multiple parts of the body/ Itchiness sporadic multiple places of my body; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration on 05Jan2021 at 16:45 on Arm left at single dose for COVID-19 immunization. The patient medical history included Cholesterol y Triglycerides high. Prior to vaccination, patient was not diagnosed with COVID-19. No known allergy, no allergies to medications, food, or other products. Concomitant medications included Multivitamin, ascorbic acid (VITAMIN C), ergocalciferol (VITAMIN D), Zinc, ibuprofen sodium (IBUPROFEN). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sporadic itching in multiple parts of the body (also reported as itchiness sporadic multiple places of her body) on 05Jan2021 at 17:30. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the event. The outcome of the event was unknown. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PUB,VITAMIN C [ASCORBIC ACID]; VITAMIN D [ERGOCALCIFEROL]; ; IBUPROFEN [IBUPROFEN SODIUM],,Medical History/Concurrent Conditions: Cholesterol high; Triglycerides high,,,['Pruritus'],1,PFIZER\BIONTECH, 936292,,,F,"she felt nauseated; sick stomach; headache; body aches; really sore arm for a couple of days; This is a spontaneous report from a contactable other health professional (patient) received via Medical Information Team. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunization. The patient medical history included arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced really sore arm for a couple of days on Dec2020, the patient felt nauseated, a sick stomach, she has a headache and body aches along with the sick stomach, all on Jan2021. The patient outcome of the events was unknown. The information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Arthritis,,,"['Abdominal discomfort', 'Headache', 'Nausea', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 936293,,,F,"tested positive for the COVID-19 virus; tested positive for the COVID-19 virus; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was tested positive for the COVID-19 virus on an unspecified date after being administered with the vaccine. The outcome of the event was unknown. Information on Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment. ,Linked Report(s) : US-PFIZER INC-2021005630 same reporter and drug, different patient and event",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 936294,,,M,"was tested and diagnosed positive for the SARS-CoV-2 infection; was tested and diagnosed positive for the SARS-CoV-2 infection; developed symptoms after being exposed at work on 27Dec2020; This is a spontaneous report from a contactable nurse. A male patient (reporter's husband) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as the first dose via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got exposed as a first line nurse working in the emergency room. The nurse reports that her husband developed symptoms after being exposed at work on 27Dec2020 five days after being administered with the first dose of BNT162B2 and he was tested and diagnosed positive for the SARS-CoV-2 infection on 27Dec2020. The outcome of the events was unknown. Information about Lot/batch number has been requested.; Sender's Comments: There is not a reasonable possibility that reported ""tested and diagnosed positive for the SARS-CoV-2 infection"" is related to BNT162B2. Event occurred only 5 days after receiving first vaccine and patient was exposed to virus at work.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/27/2020,5.0,UNK,,,,,,"['COVID-19', 'Occupational exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 936295,,,F,"Body aches; joint pain; nausea; severe chills; fever of 101.4 F; pain at injection site, redness and warm to touch; pain at injection site, redness and warm to touch; pain at injection site, redness and warm to touch; feels like she has the flu; This is a spontaneous report from a contactable nurse reporting for herself. A female patient (Age: 53; Units: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 04Jan2021 as a single dose for COVID-19 vaccination. Relevant medical history included she had COVID 19 virus on 13Nov2020. Concomitant medication was not reported. On an unspecified date in Jan2021, the patient reported that she was experiencing the same symptoms she felt when she had COVID 19 virus on 13Nov2020. She was currently experiencing the following symptoms: body aches, joint pain, nausea, severe chills, fever of 101.4 F, pain at injection site, redness and warm to touch. The patient reports that she feels like she has the flu. The outcome of the events body aches, joint pain, nausea, severe chills, fever of 101.4 F, pain at injection site, redness and warm to touch and feels like she has the flu was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: COVID-19 (she had COVID 19 virus on 13Nov2020),,,"['Arthralgia', 'Body temperature', 'Chills', 'Influenza like illness', 'Nausea', 'Pain', 'Pyrexia', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site warmth']",1,PFIZER\BIONTECH, 936297,,49.0,F,"positive COVID test result; positive COVID test result; cough; This is a spontaneous report from a contactable consumer reporting for herself. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 16Dec2020 (at the age of 49 years old) as a single dose for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided. On 21Dec2020, the patient experienced a strange cough. The patient reported that she received the first dose of COVID vaccine on 16Dec2020 and that she was then exposed to her husband who tested positive on 17Dec2020. Due to a strange cough, she was tested on 21Dec2020, which resulted in a positive COVID test result. The outcome of the events strange cough and positive COVID test was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/21/2020,5.0,UNK,,,,,,"['Cough', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 936298,MD,61.0,F,"exposed to a coworker that was COVID positive on the 29Dec2020 for 25 minutes while she was eating lunch in the lounge; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Strength 0.3 ml, lot number: EJ1685, Expiry Date: Mar2021), via intramuscular in left deltoid on 18Dec2020 at 0.3 mL, first single dose for covid-19 immunization. Medical history reported as none. There were no concomitant medications. Caller is a registered nurse that received the COVID vaccine on 18Dec2020 and her next dose is supposed to be on 08Jan2021. She was exposed to a coworker that was COVID positive on the 29Dec2020 for 25 minutes while she was eating lunch in the lounge. Her work placed her in quarantine till 12Jan2021. She was not having any symptoms. She was asking if she can get her second dose on 08Jan2021. She had a swab test that was negative for COVID on 29Dec2020. Outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/29/2020,11.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 936299,MI,41.0,F,"The left side of her face, it didn't go completely numb, but mostly; still can't chew on the side of the mouth; difficulty speaking; her eye socket, it didn't feel like her eye was there; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK923, expiration date: Apr2021), via unknown route of administration on 30Dec2020 at single dose (first dose by injection once to left upper arm, by the shoulder, a little down) for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medications were reported none. Her blood pressure was diagnosed years prior to the report, like 10+ years prior to the report, but she did not know if it had anything to do with it. The left side of her face, it didn't go completely numb on 30Dec2020, but mostly: stated her eye socket, it didn't feel like her eye was there, and her mouth, she had difficulty speaking, she still could not chew on the side of the mouth in Dec2020. Stated it felt like pulling, like something pulling, like a rope was tied and pulling backwards to the back of head and downward. States this lasted 2 days thankfully, and she did not regret getting it. She Provided weight as a lot of pounds, said she was joking. The vaccine was not prescribed by a doctor, her job offered it, she worked at a hospital, so it was voluntary and she took it. The event started maybe 6 hours after getting the vaccine, it was while she was sleeping, she woke up, she had slept, it was in the middle of the night, and was gone by Saturday for sure. This was her first dose. States site of administration was where she typically gets flu shots. The outcome of the event The left side of her face, it didn't go completely numb was recovered on 02Jan2021. The outcome of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/01/2020,,PVT,,Blood pressure high,,,,"['Feeling abnormal', 'Hypoaesthesia', 'Oral disorder', 'Speech disorder']",1,PFIZER\BIONTECH, 936300,,42.0,F,"felt a little tired this morning; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) on 04Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated she felt a little tired this morning (on 05Jan2021). It was unknown if treatment was received. It was unknown if patient was diagnosed with COVID-19 prior to vaccination, and unknown if patient had been tested for COVID-19 since the vaccination. Outcome of event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/05/2021,1.0,UNK,,,,,,['Fatigue'],1,PFIZER\BIONTECH, 936301,NC,51.0,M,"30 min after injection, right arm and hand suddenly felt tingly and a bit numb (like it was ""asleep""). The sensation moved to shoulder, traps, and face after about 30-45 minutes; 30 min after injection, right arm and hand suddenly felt tingly and a bit numb (like it was ""asleep""). The sensation moved to shoulder, traps, and face after about 30-45 minutes.; numbness/tingling mostly right side (arm, shoulder, face); This is a spontaneous report from a contactable consumer, the patient. A 51 -year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, 0.3 mL, lot number: EL0140), via an unspecified route of administration on 05Jan2021 at 05:30 PM, (at the age of 51 years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included Hashimoto's thyroiditis, hypertension and asthma. The patient was allergic to gadolinium MRI contrast, morphine (plus standard environmental allergies). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included allergy shots weekly, vitamin C, vitamin D3 and zinc quercetin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 05Jan2021 at 06:15 PM, (also reported as 30 min after injection), the patient's right arm and hand suddenly felt tingly and a bit numb (like it was ""asleep""). The sensation moved to the shoulder, traps, and face after about 30-45 minutes. The sensation started to subside after about 3-4 hours. There was never ever any weakness or sensation of throat, hives or rash, breathing issues or pain at injection site. Just a numbness/tingling mostly right side (arm, shoulder, face). The lower extremities or left side was not affected. The events were reported as non-serious. Laboratory data included a COVID-19 test (nasal swab) on 15Oct2020 which was negative. The patient was not treated for right arm and hand suddenly felt tingly and a bit numb (like it was ""asleep""), the sensation moved to the shoulder, traps, and face. right arm and hand suddenly felt tingly and a bit numb (like it was ""asleep""), sensation moved to the shoulder, traps, and face. The clinical outcome of right arm and hand suddenly felt tingly and a bit numb (like it was ""asleep""), sensation moved to the shoulder, traps, and face was recovering. It was also reported that since the vaccination, the patient has been tested for COVID-19 (nasal swab) on 15Oct2020 .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,VIT C; VIT D3;,,Medical History/Concurrent Conditions: Allergy to chemicals; Asthma; Environmental allergy; Hashimoto's thyroiditis; Hypertension,,,"['Hypoaesthesia', 'Musculoskeletal discomfort', 'Paraesthesia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 936302,,,U,"Developed covid symptoms 21Dec, tested positive 26Dec; Developed covid symptoms 21Dec, tested positive 26Dec; This is a spontaneous report from a contactable physician reporting for a patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed COVID symptoms 21Dec2020, tested positive 26Dec2020. The outcome of the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. However individuals may not be protected until at least 7 days after their second dose of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/21/2020,3.0,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 936303,,,F,"received the first dose of the Pfizer COVID vaccine on 28Dec2020 and tested positive for COVID 03Jan2021 (nasal swab) & symptomatic; received the first dose of the Pfizer COVID vaccine on 28Dec2020 and tested positive for COVID 03Jan2021 (nasal swab) & symptomatic; This is a spontaneous report from a contactable Nurse (patient). A female patient of unspecified age received BNT162B2 (Pfizer, lot number: EL0140) first dose on 28Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was tested positive for COVID 03Jan2021 (nasal swab) & symptomatic, her second dose of the vaccine is scheduled 18Jan2021. She was wondering if she still get the second dose. The outcome of the events was unknown.; Sender's Comments: The reported tested positive for COVID (nasal swab) & symptomatic after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/03/2021,6.0,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 936304,,51.0,F,"Fatigue; Dizziness, Light-headed; nausea; diarrhea; swelling of face; muscle pain; chills; joint pain; Overall feeling of unwell; This is a spontaneous report from a non-contactable other HCP (patient). A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EK5730, via an unspecified route of administration on 31Dec2020 at single dose on arm right for COVID-19 immunisation. Medical history included fibromyalgia and known allergies: Rose hip tea and Diclofenac. No COVID prior vaccination. No pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included zolpidem tartrate (AMBIEN) and duloxetine hydrochloride (CYMBALTA). The patient experienced fatigue, dizziness, light-headed, nausea, diarrhea, swelling of face, muscle pain, chills, joint pain, overall feeling of unwell; all on 01Jan2021. No treatment received for the events. Outcome of events was not recovered. Since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,AMBIEN; CYMBALTA,,Medical History/Concurrent Conditions: Allergy to plants (Rose hip tea); Fibromyalgia,,,"['Arthralgia', 'Chills', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Malaise', 'Myalgia', 'Nausea', 'Swelling face']",1,PFIZER\BIONTECH, 936305,,39.0,M,"left V2 and V3 distribution numbness/bilateral foot numbness; bilateral entire lower extremity paraesthesias; This is a spontaneous report from a contactable other hcp. A 39-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. Medical history included none. The patient's concomitant medications were not reported. The patient had left V2 and V3 distribution numbness 6 days after vaccine which resolved in 2 days. The patient had bilateral foot numbness 7 days after vaccine which resolved approximately 5 days later. After the foot numbness, the patient had progressively increasing bilateral entire lower extremity paraesthesias since Dec2020 (resolved in 5 days). The patient never had any motor weakness, or delayed tendon reflexes. No other medical conditions. No cause identified on LP, MRI brain, C, T, and L spine, or labs. Presuming vaccine related given relative likelihood of other conditions on differential diagnosis, timing, and resolution. The outcome of the event left V2 and V3 distribution numbness was recovered on 27Dec2020, of the event bilateral foot numbness was recovered on 31Dec2020, of the event bilateral entire lower extremity paraesthesias was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/01/2020,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Hypoaesthesia', 'Investigation', 'Lumbar puncture', 'Magnetic resonance imaging brain', 'Paraesthesia']",1,PFIZER\BIONTECH, 936306,ME,36.0,F,"Sore throat; Headache; Felt out of sorts/ feeling unwell; Bizarre feeling/felt really bad; wondering if being on Stelera made the symptoms from the COVID Vaccine worse; extreme/ severe fatigue; lightheaded; soreness around injection/Sore arm; felt run down; chills; This is a spontaneous report from a contactable nurse (patient). This 36-years-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, Expiry Date: 31Mar2021), via unspecified route at left arm on 21Dec2020 14:00 at single dose for COVID-19 immunization; she also started to receive ustekinumab (STELERA injection), via subcutaneous from 2017 (last injection on 04Nov2020) at unspecified dose every 12 weeks for psoriasis. Medical history was none. Concomitant medications were not reported. No additional vaccines administered on same date of Pfizer vaccine. Historical vaccine included influenza vaccine on Nov2020 for immunization, which was 5 weeks prior to COVID vaccine. Vaccination facility type was hospital. At night of vaccination on 21Dec2020, patient felt run down, thought she had chills. She did not have fever. She woke up next day 22Dec2020 with sore arm/ soreness around injection, was otherwise fine. Day 2, 3, and 4 post vaccine was sick (23Dec2020). She had a sore throat, headache, and extreme/ severe fatigue on 23Dec2020. She was not feeling well/ felt out of sorts on 23Dec2020. She expected to wake up feeling unwell. On 23Dec2020 and 24Dec2020 she felt really bad. Could have been in bed all day. She still did not have fever. She was lightheaded and had a bizarre feeling on 23Dec2020. She woke up 26Dec2020 and felt completely fine. Patient was wondering if being on ustekinumab made the symptoms from the COVID Vaccine worse. Action taken for ustekinumab was unknown. Outcome of events was recovered on 26Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,STELERA,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Chills', 'Dizziness', 'Drug interaction', 'Fatigue', 'Feeling abnormal', 'Headache', 'Malaise', 'Oropharyngeal pain', 'Vaccination site pain']",1,PFIZER\BIONTECH, 936307,IL,29.0,F,"chills; temp of 100.2; muscle aches; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 05Jan2021 12:00 PM at single dose for covid-19 immunization. Medical history included none. Known allergies was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient experienced chills, temp of 100.2, and muscle aches on 06Jan2021 12: 00 AM. Treatment received for the adverse event was unknown. The outcome of the events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'Chills', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,OT 936308,WA,28.0,F,"Mild rash and itching around injection site; itching around injection site (multiple small red bumps); itching around injection site (multiple small red bumps); This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm at 14:45 on 29Dec2020 at single dose for COVID-19 immunization. Medical history included celiac disease, Sjogren's syndrome, connective tissue autoimmune disease, allergies to Gluten. Concomitant medication included cetirizine, citalopram, curcuma longa (TURMERIC), ergocalciferol (VIT D), ethinylestradiol, norethisterone acetate (MICROGESTIN), fish oil, hydroxychloroquine, pantoprazole, simethicone, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced mild rash and itching around injection site (multiple small red bumps) on 31Dec2020, all events were reported as non-serious. The patient did not receive any treatment from events. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/31/2020,2.0,OTH,; ; TURMERIC [CURCUMA LONGA]; VIT D; MICROGESTIN; ; ; ; SIMETHICONE,,Medical History/Concurrent Conditions: Autoimmune disorder (connective tissue autoimmune disease); Celiac disease; Connective tissue disorder (connective tissue autoimmune disease); Gluten sensitivity (Known Allergies: Gluten); Sjogren's syndrome,,,"['Vaccination site papule', 'Vaccination site pruritus', 'Vaccination site rash']",1,PFIZER\BIONTECH,OT 936309,OR,33.0,M,"Fever 101.4; Muscle aches; headache; chills; Dose number=1on 17Dec2020/ Dose number=2 on 05Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm at 09:30 AM on 05Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on left arm at 01:30 P.M on 17Dec2020 at single dose for Covid-19 immunization. The patient had no allergies to any medications, food, or other products. The patient experienced Fever 101.4 approximately 14 hours after getting second dose. Muscle aches, headache and chills at 11:00 PM on 05Jan2021. All events were reported as non-serious. The outcome of events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine; The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events fever, muscle aches, headache and chills was not recovered. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Body temperature', 'Chills', 'Headache', 'Inappropriate schedule of product administration', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,OT 936310,CA,50.0,F,"both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; felt tired most of the day; felt soreness at injection site; joint pain; This is a spontaneous report from a non-contactable nurse (patient). A 50-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1685), via an unspecified route of administration on left arm at 13:45 on 21Dec2020 at single dose for Covid-19 immunization. Medical history included hypertension, central serous retinopathy, known allergies to penicillin and Nickel. Concomitant medication included losartan, hydrochlorothiazide, cetirizine hydrochloride (ZIRTEC) and multivitamin. The patient previously took clindamycin, Septra and Keflex and experienced drug allergy. Within 30 min on 21Dec2020 started at 02:30 PM, both ears felt hot, mildly itchy, slightly puffy, and bright red in color. The patient's tongue and mouth felt slightly tingly with a metallic taste. She felt tired most of the day. Next day felt soreness at injection site and joint pain. Soreness at injection site lasted several more days. Events resulted in Doctor or other healthcare professional office/clinic visit, events were reported as non-serious. The patient received Benadryl 50 mg & additional dose of Zyrtec as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on unknown date. No follow up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,WRK,; ; ZIRTEC,,Medical History/Concurrent Conditions: Central serous retinopathy; Hypertension; Nickel sensitivity (known allergies); Penicillin allergy (known allergies),,,"['Arthralgia', 'Auricular swelling', 'Dysgeusia', 'Ear pruritus', 'Erythema', 'Fatigue', 'Feeling hot', 'Paraesthesia oral', 'Vaccination site pain']",1,PFIZER\BIONTECH, 936311,VA,69.0,F,"Light headed; weakness; body aches; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 10:00 at single dose in her left arm for covid-19 immunization. The patient medical history was not reported. The patient concomitant that the patient received within 2 weeks of vaccination included ""blood pressure"" (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The patient experienced light headed, weakness, body aches on 05Jan2021 10:00. No treatment received for the adverse event. The outcome of the events was recovered in Jan2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Asthenia', 'Dizziness', 'Pain']",1,PFIZER\BIONTECH, 936312,,64.0,F,"Nausea; Chills; sweats; vomit; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (Lot number and expiry date unknown), via an unspecified route of administration on 02Jan2021 14:15 at SINGLE DOSE in the left arm for COVID-19 immunization. Medical history included depression from an unknown date. Concomitant medication included marijuana, depression meds and sleep meds. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Jan2021 04:00, the patient experienced nausea, chills, sweats and vomit. The patient did not receive any treatment for the events. The outcome of the events was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/06/2021,4.0,OTH,MARIJUANA,,Medical History/Concurrent Conditions: Depression,,,"['Chills', 'Hyperhidrosis', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH, 936313,MA,58.0,M,"diarrhea; vomiting; body aches; fever; nausea; lethargy; sob (Shortness of breath); This is a spontaneous report from a contactable nurse. A 58-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EJ1686, from 04Jan2021 10:45 to 04Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included heart disorder and prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included prasugrel hydrochloride (EFFIENT), metoprolol, ASA, lisinopril and atorvastatin. The patient experienced diarrhea, vomiting, body aches, fever, nausea, lethargy and shortness of breath (SOB) on 04Jan2021. The patient did not receive any treatment for the adverse events. The outcome of the evet was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,EFFIENT; ; ASA; ;,,"Medical History/Concurrent Conditions: COVID-19 (if covid prior vaccination Yes); Heart disease, unspecified",,,"['Diarrhoea', 'Dyspnoea', 'Lethargy', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test', 'Vomiting']",1,PFIZER\BIONTECH, 936314,,29.0,F,"body feels like a furnace; shaking from her core; All main muscle groups sore/tense; All main muscle groups sore/tense; mild chills; arm hurts so bad, like deep in her arm pit bad; Shooting headache; Vivid stressful dreams; Nauseous; This is a spontaneous report from a non-contactable pharmacist. A 29-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at the right arm on 05Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 17Dec2020 16:45, at the right arm for COVID-19 immunization. On 05Jan2021, the patient experienced mild chills at 19:00 and took acetaminophen (TYLENOL) and went to bed, at 23:30, patient reported shaking from her core and all main muscle groups sore/tense. In addition, patient stated her arm hurts so bad, like deep in her arm pit bad, had shooting headache, vivid stressful dreams, & was nauseous on the same day of 05Jan2021. On 06Jan2021 04:00, the patient also stated her body feels like a furnace. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for it since the vaccination. The patient was recovering from the events. No follow up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Abnormal dreams', 'Chills', 'Feeling hot', 'Headache', 'Muscle tightness', 'Myalgia', 'Nausea', 'Pain in extremity', 'Tremor']",2,PFIZER\BIONTECH, 936315,,28.0,F,"Muscle fatigue; Chills; Headache; Fatigue; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on an unspecified date at a single dose then intramuscularly (left arm) on 05Jan2021 18:30 at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. There was no relevant medical history. The patient had no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Jan2021 19:00, the patient experienced Muscle fatigue, chills, headache and fatigue. No treatment was provided in response to the events. The patient assessed the events as non-serious. The patient underwent COVID test post vaccination via nasal swab (PCR) on 21Dec2020 and was negative. The outcome of the events was recovering. No follow-up attempts are possible, information about lot/batch cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,01/05/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Fatigue', 'Headache', 'Muscle fatigue', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 936316,,,F,"hives all over; This is a spontaneous report from a non-contactable Nurse. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration on 21Dec2020 at single dose (dose 1) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received her first dose of the COVID vaccine on 21Dec2020; she woke up on 04Jan2021 (2 weeks later) with hives all over. Patient stated that she know this can happen right after injection, but it has been 2 weeks. Patient stated that she is due for the 2nd dose soon and was concerned. Event outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,01/04/2021,14.0,UNK,,,,,,['Urticaria'],1,PFIZER\BIONTECH, 936317,CA,51.0,F,"erythematous swollen thick raised sores with vesicles; 2 swollen erythematous maculopapular round areas on the left side of neck; feel more inflamed; burning feeling to the touch; Is getting slightly painful; Discomfort; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 27Dec2020 05:30 at a single dose for COVID-19 immunization. Medical history included atopic dermatitis. Patient previously took DUPIXENT, last dose was 18Dec2020 (due to a lack of knowledge about DUPIXENT) and the COVID vaccine, patient have not taken next due dose of DUPIXANT on 01Jan2021). Patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. On 31Dec2020 02:00 (reported as day 4 after the injection), patient developed 2 swollen erythematous maculopapular round areas on the left side of neck that were sore and slightly have a burning sensation (not pins/needle) to the touch also described as 2 very large erythematous swollen thick raised sores with vesicles on the left side of neck. Patient showed photos to internist a couple days later when they did not go away. As of this reported, it was now day 10 and they are not bigger but they feel more inflamed and have more of a burning feeling to the touch. The small vesicle on each sore had disappeared. Patient stated she had a history of atopic dermatitis but looked and felt nothing like it. Initially had little vesicular areas in the center but the vesicles aren't there today. Discomfort remains. No associated fever or headache. Patient had read of zoster developing with COVID-19 infection, but not associated with the actual vaccine. She was asking if this might be a weird varicella zoster reaction to the vaccine and any data about this. This did not seem to be going away and was getting slightly painful (though so far tolerable) though does not seem to be spreading at this point. Outcome of the events was not recovered. No treatment was received for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/31/2020,4.0,PVT,,,Medical History/Concurrent Conditions: Atopic dermatitis,,,"['Blister', 'Discomfort', 'Inflammation', 'Pain', 'Rash maculo-papular', 'Skin burning sensation']",1,PFIZER\BIONTECH, 936318,AZ,30.0,F,"within 6 hours experienced severe chills and covid-like symptoms, she also tested positive for COVID-19; within 6 hours experienced severe chills and covid-like symptoms, she also tested positive for COVID-19; This is a spontaneous report from a contactable nurse. A 30-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in left arm on 04Jan2021 11:30 at a single dose for COVID-19 vaccination. Medical history included allergies to Sulfa diagnosed in 2008, Allergies to Strawberries diagnosed when she was very young, Diamox allergy diagnosed in 2008, dyslexic, and Obesity but never been treated. Concomitant medication included levothyroxine (LEVOTHYROXINE), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), zinc (ZINC), nd cetirizine hydrochloride (ZYRTEC). The patient previously took diamox [acetazolamide] and experienced drug hypersensitivity. Patient received first dose Monday, 04Jan2021, then she experienced severe chills and Covid like symptoms. Apparently, she tested positive for COVID 19. She ws not sure if it was a false positive or if she actually has COVID, but was concerned because her husband has cancer and was immunocompromised. Literally, she got the vaccine because her OB/GYN told her she needs to get it as soon as possible. She did blood work and she tested negative for pregnancy. There was no prescriber as it was given as part of her work. Fifteen minutes after receiving the vaccine, she had the worst headache she has ever had in her life. Six hours after that, she had such bad chills. That night, it worsened and it got better every hour when she took something. She said her congestion was still present. She stated she took Tylenol and hour later and it subsided. The outcome of the events was not recovered. The patient underwent laboratory date including negative antibodies on an unknown date, blood work on Mar2020 with unknown result, then on 05Jan2020 tested positive to COVID 19 by saliva test at 09:15 and nasal test at 11:30 Information about Lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; ; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Dyslexia; Fruit allergy (diagnosed very young Allergies to Strawberries); Obesity (Obesity but never been treated); Sulfonamide allergy (diagnosed in 2008 allergies to Sulfa),,,"['Chills', 'Headache', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 936319,TX,39.0,F,"swollen lymph nodes at neck and sore to the touch; swollen lymph nodes at neck and sore to the touch; swollen and stiff neck; swollen and stiff neck; chills; hot flashes; radiating pain of arms; numb fingers; blue hands and feet; joint pain; muscle aches; weakness; tirednes; lethargic; This is a spontaneous report from a contactable Other Health Professional (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EL0140, via an unspecified route of administration in the left arm on 04Jan2021 16:45 at a single dose for COVID-19 immunization. Medical history included hypothyroidism, depression, ADHD, overweight, asthma and known allergies to milk, cat, roach mix, dust mites and bermuda grass. Concomitant medication included levothyroxine sodium (SYNTHROID), fluoxetine hydrochloride (PROZAC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), trazodone and montelukast. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination nor was she tested for covid post vaccination. The patient experienced swollen lymph nodes at neck and sore to the touch, swollen and stiff neck, chills, hot flashes, radiating pain of arms, numb fingers, blue hands and feet, joint paint, muscle aches, weakness, tiredness, and was lethargic, all on 04Jan2021 at 17:30 PM with outcome of recovering. The events were reported as non-serious with no treatment received. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,SYNTHROID; PROZAC; ADDERALL; ;,,Medical History/Concurrent Conditions: ADHD; Allergy to animal; Allergy to insect sting; Asthma; Depression; Grass allergy; Hypothyroidism; Milk allergy; Overweight,,,"['Arthralgia', 'Asthenia', 'Chills', 'Fatigue', 'Hot flush', 'Hypoaesthesia', 'Lethargy', 'Lymph node pain', 'Lymphadenopathy', 'Musculoskeletal stiffness', 'Myalgia', 'Pain in extremity', 'Skin discolouration', 'Swelling']",1,PFIZER\BIONTECH, 936320,MD,59.0,F,"numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; This is a spontaneous report from a contactable healthcare professional. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL01284, expiry date not reported), via an unspecified route of administration in the right arm on 31Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included pituitary tumor/prolactinoma. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. Concomitant medications were none. On 31Dec2020 at 10:45, the patient experienced numbness in right fingers along with tingling. The patient moved to back of neck and side of face. The right side of face was completely numb. It began with tingling and then moved to numbness. Her right eye was blurred for short period. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Prolactinoma,,,"['Hypoaesthesia', 'Paraesthesia', 'Vision blurred']",UNK,PFIZER\BIONTECH, 936321,PA,36.0,F,"Began itching about 1/2 hour afterwards; Woke up next morning with hives on left forearm and up left arm; This is a spontaneous report from a contactable nurse (patient). A non-pregnant 36-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via intramuscular route of administration on 05Jan2021 12:15 at a single dose on right arm for COVID-19 immunization at workplace clinic. Medical history included anxiety, attention deficit hyperactivity disorder (ADHD), and seasonal allergy from unknown dates. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. The patient reported that she began itching about 1/2 hour afterwards on 05Jan2021 13:00 and she woke up next morning with hives on left forearm and up left arm. The events were non-serious. Antihistamine was given as treatment for the events. Outcome of the events was recovering. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,WRK,,,Medical History/Concurrent Conditions: ADHD; Anxiety; Seasonal allergy,,,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,OT 936322,AZ,43.0,F,"developed right forearm numbness; intermittent bilat lower leg numbness / bilat lower leg numbness was constant all day; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EL1284, expiry date was unknown) via an unspecified route of administration at the left arm on 30Dec2020 09:30 AM at a single dose. for COVID-19 immunization. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Jan2021, 6:30 pm and on 03Jan2021, the patient developed intermittent bilat lower leg numbness. On 04Jan2021, bilat lower leg numbness was constant all day and at 4pm that same day, she developed right forearm numbness. No weakness, just numbness. On 05Jan2021, leg numbness has resolved but still having slight right forearm numbness. On 06Jan2021, still no leg numbness but still having slight right forearm numbness. The events resulted in emergency room/department or urgent care. The patient recovered from the event ""intermittent bilat lower leg numbness / bilat lower leg numbness was constant all day"" on 05Jan2021. Outcome of the event ""developed right forearm numbness"" was recovering. No treatment was performed in response to the adverse events. The events were assessed as Non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['Hypoaesthesia'],1,PFIZER\BIONTECH, 936323,,,U,"patient got the first dose of the COVID vaccine on 18Dec2020/was positive via COVID PCR test on 26Dec2020; patient got the first dose of the COVID vaccine on 18Dec2020/was positive via COVID PCR test on 26Dec2020; had a COVID exposure on 23Dec2020; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Patient's medical history was not reported. Concomitant medication included chemotherapy. It was reported that patient got the first dose of the COVID vaccine on 18Dec2020 and then had a COVID exposure on 23Dec2020 and was positive via COVID PCR test on 26Dec2020. It was mentioned that patient is a chemotherapy patient. The patient was given the antibodies for COVID on 28Dec2020 and the patient is currently doing well. Reporter's question was that the patient was scheduled to get the second dose of the vaccine on 08Jan2021 and the reporter is wondering if given this patient's situation, is it safe for the patient to receive the second dose or if there are any recommendations on when the patient should receive the second dose. Outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and SARS-CoV-2 test positive cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/23/2020,5.0,UNK,,,,,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 936324,PA,66.0,F,"Seasonal allergy; allergic conjunctivitis; yeast infection; yeast infection; she didnt feel great, she was off; grumpy; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK5730 and expiry date: Mar2021), via an unspecified route of administration in arm on 22Dec2020 at single dose for Covid-19 Immunization. Medical history included yeast infection 20 years ago (in 2000). There were no concomitant medications. The patient received her first dose on 22Dec2020. She is due for the second dose on 12Jan2021. She got allergic conjunctivitis on 23Dec2020, yeast infection on unspecified date in Dec2020, and seasonal allergies that were very bad, which doesn't typically happen to her this time of year on 26Dec2020. She had a Covid test that was negative. She wants to know if she should get the second dose. The conjunctivitis was not bad, it stopped after she took out her contacts, used allergy drops and it cleared it up. The last one she had yeast infection was like was 20 years ago, but she treated it herself and it is gone now. She got the conjunctivitis within 24 hours of receiving the first dose, she got the yeast infection 2-3 days after the first dose, and the allergies began about 4 days after the first dose. The conjunctivitis and the yeast infection have both resolved but the allergies are still ongoing, they come and go, the intensity comes and goes, she even checked the pollen count and it was non-existent. She had a Negative Covid Test on 28Dec2020. She had a Negative Antibody Test back in Jun2020. She has had no positive test for Covid prior to getting the vaccine. She has had No issues with vaccines in the past. She stated that she's read all the stuff on the website, and is has the usual stuff, yes her injection site was a little... not bad, she did not feel great, she was off, and grumpy on unspecified date in Dec2020. The events conjunctivitis and the yeast infection resolved on unspecified date; the event seasonal allergy was not recovered; and the remaining events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: Yeast infection (20 years ago),,,"['Antibody test', 'Conjunctivitis allergic', 'Disease recurrence', 'Feeling abnormal', 'Fungal infection', 'Irritability postvaccinal', 'SARS-CoV-2 test', 'Seasonal allergy', 'Skin test']",1,PFIZER\BIONTECH, 936325,,,F,"her lips and gums were mildly swollen; her lips and gums were mildly swollen; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included latex allergy with only swelling. The patient's concomitant medications were not reported. On Dec2020, the patient reported has mild latex allergy with only swelling and after receiving the vaccine, she noticed her lips and gums were mildly swollen. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: Latex allergy (with only swelling),,,"['Gingival swelling', 'Lip swelling']",UNK,PFIZER\BIONTECH, 936326,CT,60.0,F,"Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheezing; Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing asthma (asthmatic) which had been under control for years. The patient's concomitant medications were not reported. In Jan2021, the patient had arm pain; full body aches; headaches; had frequent bathroom use (not diarrhea ""more of a mix""); mild wheezing; and nausea. The patient had received paracetamol (TYLENOL) as treatment for the arm pain. The outcome of the events, 'arm pain', 'full body aches', 'headaches', 'frequent bathroom use', 'mild wheezing' and 'nausea', was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/01/2021,,UNK,,Asthmatic (under control for years),,,,"['Frequent bowel movements', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Wheezing']",UNK,PFIZER\BIONTECH, 936327,TX,51.0,F,"Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness all over; Neck is also really sore; head hurt/headache was in the occipital area; mild pain at the injection site; Her whole arm is swollen and sore/Sore upper arm/arm achy; Her whole arm is swollen and sore/Sore upper arm; whole arm felt warm/warm to the touch; This is a spontaneous report from a contactable Nurse(patient). A 51-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization(reported as for work). She worked in the hospital. She just got it at work. She didn't have a prescribing doctor. Her first dose was 3 weeks before today. Her first vaccine was a Pfizer vaccine with lot:13551. She got the 2nd dose 20 days later. She got the second dose on 05Jan2021. Medical history and concomitant medications reported as none. Also reported she did have other medical conditions, but she got the go ahead to get the vaccine from her rheumatologist. Patient received her second dose of vaccine 05Jan2021 and was experiencing fever, chills, achiness during the night last night on 06Jan2021. She was asking if she was experiencing adverse events or Sars-COV-2 symptoms. At first, she had mild pain at the injection site, but then in the middle of the night, her whole upper arm became sore and swollen. Not just at the injection site. Onset date of sore upper arm was 05Jan2021. She developed rigors/chills. She had achiness all over. She checked her temperature a half an hour to 45 min ago, and it was 99.9-100.2. She usually runs 96-97. It was around 3-4 am that she felt chilled, but not feverish. She was just chilled/ had rigors. It was a couple hours later at 7 am that she felt feverish. They were not high readings. In the past 10 minutes, her head had started to hurt. Her neck was also really sore. Her headache was in the occipital area. It had only been 10 mins that this had came on, and it was about the same. It really hurt. Onset date of headache/ neck pain was 06Jan2021. Her whole arm was swollen and sore. It was warm to the touch. Her whole arm felt warm and achy. She had used an ice pack, and it did help some. She was assuming this was just an expected immune response. She just didn't want to put anyone at risk. She was always very careful. She mostly worked from home, but she was in the office yesterday with two masks and a face shield. She also used a lot of spray and hand sanitizer. The outcome of events fever, achiness, ""Her whole arm is swollen and sore/Sore upper arm/arm achy"" and headache, neck pain was not recovered, of chills was recovered in Jan2021, of other events was unknown. Sore upper arm was reported as worsened.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,01/01/2021,,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'Chills', 'Feeling hot', 'Headache', 'Neck pain', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 936328,CT,35.0,F,"tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left upper arm on 18Dec2020 15:30 at a single dose for COVID-19 immunisation. Medical history included high blood pressure and had electrocardiogram (EKG) unknown result a week before vaccination in Dec2020. Concomitant medication included acetylsalicylic acid (ASPIRIN), lisinopril, and guaifenesin (MUCINEX). It was reported that patient tested positive for COVID on 31Dec2020. She has not gotten her second dose but it was scheduled for 08Jan2021 for which will still be in quarantine then and requested guidance on when/if she should get the second dose. Patient explained her parents have COVID and that the rapid test for the COVID test was how she found out she had COVID. The patient has not recovered from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/31/2020,13.0,UNK,ASPIRIN (E.C.); ; MUCINEX,,Medical History/Concurrent Conditions: Blood pressure high; EKG (unknown result),,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 936329,MN,,M,"Right leg paresthesia and slight left leg paresthesia; tingling mainly in the right foot and calf; Itching mainly in the right foot and calf; Slight burning sensation mainly in the right foot and calf; Most recent COVID-19 vaccine was administered 17 days after first dose of COVID-19 vaccine; This is a spontaneous report from a contactable physician (patient). A 31-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), intramuscular in left arm, on 04Jan2021 at 15:00, at a single dose, for COVID-19 immunization. The patient's medical history included gastritis. There were no concomitant medications. The patient previously took the first dose of BNT162B2 on 18Dec2020 at 2:30 PM for COVID-19 immunization (intramuscular in left arm; Lot Number: EL0140). The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jan2021 at 3 PM, the most recent COVID-19 vaccine was administered in a hospital, 17 days after first dose of COVID-19 vaccine. On 04Jan2021 at 10 PM, the patient experienced right leg paresthesia and slight left leg paresthesia; and tingling, itching, and slight burning sensation mainly in the right foot and calf. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Gastritis,,,"['Burning sensation', 'Inappropriate schedule of product administration', 'Paraesthesia', 'Pruritus']",2,PFIZER\BIONTECH,OT 936330,TX,31.0,M,"Arm pain; swollen and tender supraclavicular lymph node (injection side); swollen and tender supraclavicular lymph node (injection side); general fatigue; sinus congestion; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), with the first dose on 15Dec2020 and second dose on 05Jan2021; both intramuscular in the left arm at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy and lactose allergy. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 05Jan2021, the patient experienced arm pain, swollen and tender supraclavicular lymph node (injection side), general fatigue, and sinus congestion. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious by the reporter. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Food allergy; Penicillin allergy,,,"['Fatigue', 'Lymph node pain', 'Lymphadenopathy', 'Pain in extremity', 'Sinus congestion']",2,PFIZER\BIONTECH,OT 936331,TX,,U,"sick; fever; chills; body aches; This is a spontaneous report from a contactable healthcare professional. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at a single dose for Covid-19 immunization. The patient is a healthcare worker and she had the corona virus on 23Nov2020. The patient's concomitant medications were not reported. The patient received the Covid vaccine on 18Dec2020. On an unspecified date, the patient got really sick after the first vaccine with fever, chills, body aches, etc. The patient was scheduled to receive the second dose on Friday, 08Jan2020, the patient asked if the patient should still take the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,,,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Chills', 'Illness', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 936332,MN,33.0,F,"swollen lymph node a couple of days later/swollen lymph node a couple of days later. Which is still a little swollen but improving; pain at injection site/painfulness at the injection site; shoulder became very red/painfulness at injection site and redness/ was a defined red mark where the injections was; This is a spontaneous report from a contactable nurse. A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK9231, expiry date: 30Apr2021), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. Medical history included immunosuppression. Concomitant medication included ongoing vedolizumab (ENTYVIO) for immunosuppresion. The patient got a couple of the side effects listed. She developed painfulness at the injection site, and it was red a couple of days. She is wondering if she needs to be worried about getting the second one. It was pretty painful that night. It was pretty painful for the next day. If someone barely brushed up against it, it was very painful. Two days later, her husband noticed her shoulder was very red. And then she realized there was a defined red mark where the injections was. The pain is fine now. She didn't get a rash or have trouble breathing. She did have a swollen lymph node a couple of days later. Which is still a little swollen but improving. She does take an immunosuppressant. The outcome of the events pain at injection site and shoulder became very red/painfulness at injection site and redness/ was a defined red mark where the injections was recovered, while recovering for the event swollen lymph node a couple of days later was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,UNK,ENTYVIO,,Medical History/Concurrent Conditions: Immunosuppression,,,"['Lymphadenopathy', 'Vaccination site erythema', 'Vaccination site pain']",1,PFIZER\BIONTECH, 936333,MI,39.0,F,"left arm is really sore; fever/100.7 degrees Fahrenheit; chills/ shivering; feeling cold; body aches; sick; she was shaking and shivering; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular (left deltoid), on 05Jan2021 at 11:00, at a single dose for COVID-19 immunization and preventative (prophylaxis). The patient has no relevant medical history and has no concomitant medications. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient is a registered nurse (RN) and received her first dose of the Pfizer COVID-19 vaccine yesterday. She had side effects from it. Last night (05Jan2021) she was kind of sick, she experienced fever and chills. She was in bed and trying to get cozy, but she was shaking and shivering, she does not know the exact time she experienced these since she was in bed. She checked her fever at 4am and it was 100.7 degrees Fahrenheit. She took Tylenol this morning and she does not think she has a fever as of now. She felt better and but she was still cold but not like last night. She still has body aches, but she is better now, and her body aches were worse when she had the fever. Now that her fever was down, she feels better, she does not know if she feels better since she took the Tylenol. She stated that none of her coworkers got sick. She just wanted to know if she will get better and if these were normal. She hopes she gets better since she never gets sick. She also reported that her left arm was really sore, there is no swelling. When she moves her arm, she can feel it was hurting and she was not able to sleep on her left side. She did not feel pain when she received the injection, she felt the pain after in her left arm. The events did not require emergency or physician visit. Outcome of the event body aches was not recovered, for event ""left arm is really sore"" was unknown, while for the remaining events was recovering. The reporter assessed the events as non-serious and related to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'Chills', 'Feeling cold', 'Illness', 'Pain', 'Pyrexia', 'Tremor', 'Vaccination site pain']",UNK,PFIZER\BIONTECH,OT 936334,CO,28.0,F,"Fever with temperature of 102.4F; Chills; Body aches; sore joints; Vomiting; The patient received the second dose 19 days from the first dose; This is a spontaneous report from a contactable nurse (patient). A 28-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as Covid 19 vaccine), first dose intramuscular right arm on 17Dec2020 17:30 [05:30 PM](Ej1685; expiration date: unknown) at a single dose and second dose intramuscular right arm on 05Jan2021 17:30 [05:30 PM] (lot number: EK9231; expiration date: unknown) at a single dose for covid-19 vaccination. The patient's medical history was not reported. Concomitant medication included birth control medication. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination. The patient experienced fever with temperature of 102.4F, chills, body aches, sore joints and vomiting on 06Jan2021 01:00. The patient received the second dose on 05Jan2021 17:30 which was 19 days from the first dose. The patient did not received treatment for the adverse event. The patient has not tested for COVID-19 since the vaccination. The reporter assessed the events as non-serious. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,UNK,,,,,,"['Arthralgia', 'Body temperature', 'Chills', 'Inappropriate schedule of product administration', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,OT 936335,NC,41.0,F,"I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which began to subside within about 2 days; my upper left molar started aching (toothache); I had a sharp intermittent pain in my left jugular/carotid neck area; felt a little ""tipsy; I had intermittent numbness and tingling in my left jaw area; I had intermittent numbness and tingling in my left jaw area; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose in the left arm for COVID-19 immunization. Medical history included allergies to Sulfa antibiotics. The patient's concomitant medications were not reported. The patient previously took meperidine (DEMEROL) and experienced allergies. Within an hour of receiving the vaccine, the patient had a sharp intermittent pain in her left jugular/carotid neck area and felt a little ""tipsy"". This continued for about one day. Then last week (approximately 28Dec2020), her upper left molar started aching (toothache). This subsided within about 2 days. Then on 30Dec2020, she developed a severe earache, which began to subside within about 2 days. Around 31Dec2020 through 04Jan2021, she had intermittent numbness and tingling in her left jaw area. Last night (05Jan2021), she developed a sharp pain on the back side of her left neck area. She went to the doctor on 04Jan2021, and no treatment was prescribed. She began self-medicating with an old prescription of prednisone on the evening of 04Jan2020 due to being fearful of developing Bell's Palsy. Most of her symptoms have now improved after beginning the prednisone. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/01/2020,,PVT,,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,"['Back pain', 'Ear pain', 'Feeling abnormal', 'Hypoaesthesia', 'Neck pain', 'Paraesthesia', 'Toothache']",1,PFIZER\BIONTECH, 936336,,,F,"developing symptoms of COVID; This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse asked if the patient can continue with the 2nd dose of COVID 19 vaccine after developing symptoms of COVID on an unspecified date. Outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Suspected COVID-19'],1,PFIZER\BIONTECH, 936337,IN,31.0,F,"Developing symptoms of covid/ symptoms of Covid after having the vaccine; Developing symptoms of covid/ symptoms of Covid after having the vaccine; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EJ1688, via an unspecified route of administration in the left arm, on 21Dec2020 at a single dose for covid-19 immunisation as she works with disabled people and for general community health. Patient's medical history was none. Family history included her kids/children had covid (unknown if ongoing). There were no concomitant medications. It was reported that the patient had symptoms of covid after having the vaccine with outcome of recovering. The patient received the first dose of covid vaccine on 21Dec2020 and on the 02Jan2021 she started developing symptoms of covid. She mentioned that her children have virus and she had the covid test done. She wanted to know if she can get the second dose of the vaccine. She queried for her co-worker who has the Covid and was told to not take the vaccine yet and how long they need to wait. She was tested this morning. She has not gotten the results. Her kids had Covid and she felt certain she had it because she has symptoms. It comes and goes. It was better during the day and worse at night. She received the vaccine because she works with disabled people where there are extremely high numbers of the virus. She also got it for general community health. The Covid test was done on 06Jan2021 with unknown result.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,01/02/2021,12.0,UNK,,,Medical History/Concurrent Conditions: COVID-19 (her kids/children); Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Adverse event', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 936338,MD,52.0,F,"Had pain at the injection site; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; difficulty breathing; she has a bad cough; This is a spontaneous report from a non-contactable consumer. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration from 05Jan2021 to 05Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. In Jan2021, the patient reported all of the symptoms on the sheet including injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell. The reporter also stated that the patient had difficulty breathing, she stated that every few words she has to catch her breath and she has a bad cough. The outcome of the event was unknown. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/01/2021,,UNK,,,,,,"['Arthralgia', 'Chills', 'Cough', 'Dyspnoea', 'Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",UNK,PFIZER\BIONTECH, 936339,IL,47.0,F,"Headache; fatigue and feeling run down; developed a clicking sensation in her right ear/ persistent like ""if you have water in your ear""/ notices it a lot at night/ happens mostly at night but is happening right now; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization, also reported as ""for work."" The patient has no medical history and there were no concomitant medications. The patient received the first dose of the COVID 19 vaccine on 22Dec2020. She was scheduled to receive the second on 12Jan2021, Tuesday. Since receiving the vaccine, the night of receiving it, she developed a clicking sensation in her right ear. It hasn't gone away. It was kind of like ""when you have water in your ear."" It is not popping like on an airplane. She can trigger it if she hums or makes her vocal cords vibrate. She can make it happen. It is not painful. She notices it a lot at night. It might be a eustachian tube thing. At first, she was wondering if it could be coincidental. She hasn't experience it before though. It could be related to a sinus thing. But she hasn't realized a sinus issue. She thought, by now it would have gone away. No one has looked in her ear though. She works in healthcare. She doesn't have a prescribing doctor. She got the vaccine at work. She noticed the clicking in the middle of night so she can't say an exact time of onset. She thought it might have been improving, but she thinks she is just getting used to it. She is less aware of it now. The patient asked if she should be seen by her HCP or have her ears checked out. She asked if the clicking sound that developed in her ear after getting the first dose of the vaccine was normal? It is persistent like ""if you have water in your ear."" It happens mostly at night but is happening right now. The patient further reported having the expected side effects of headache, fatigue and feeling run down since an unknown date. The patient has not recovered from the event ""developed a clicking sensation in her right ear/ persistent like ""if you have water in your ear""/ notices it a lot at night/ happens mostly at night but is happening right now."" Outcome of the events ""headache"" and ""fatigue and feeling run down"" was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Fatigue', 'Headache', 'Tinnitus']",1,PFIZER\BIONTECH, 936340,,,M,"significant neck stiffness; both [of his] lips became numbed for six hours; tingling sensation; little bumps around [his] lips [developing] 12 hours after receiving the vaccine; severe headaches; dizziness; low grade fever around 99.5; a little bit of tachycardia; shortness of breath; This is a spontaneous report from a contactable other healthcare professional (HCP). A male patient of an unspecified age (reported as 43, unit not specified) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated experiencing ""a lot of side effects"" following the receipt of the Pfizer-BioNtech COVID-19 vaccine. He explained discussing with his physician who informed him that: individuals having a severe reaction to the first dose shouldn't take the second dose, however this severe reaction is ""not qualified"". Therefore, patient asked if what he experienced was a severe reaction to the vaccine. He then specified having a ""significant neck stiffness"" which ""abated after two days"", and he ""couldn't turn [his] head"" because of it. He added that ""both [of his] lips became numbed for six hours"", after which a ""tingling sensation"" perdured for an additional ""six hours"" then ""sensation came fully"". He also mentioned experiencing: ""little bumps around [his] lips [developing] 12 hours after receiving the vaccine"", ""severe headaches"", a ""resting heartrate of 98-100"", ""dizziness"" when he walked, and a ""low grade fever around 99.5 [which] never hit a 100"". He then explained that: the ""severe symptoms went away after 24 hours"", and during the second day, he only had ""a little bit of tachycardia and shortness of breath"" and ""had to miss two days of work as a result of that"". He stated that he was fine the third day. He expressed being ""reluctant but wants to take the second dose"" of the vaccine. He explained his dissatisfaction on the lack of resources provided by the vaccination provider after receiving the vaccine. He specified only receiving a vaccination card with no info, and only found our number after a delayed period. The outcome of the events was recovered on an unspecified date. The reporter assessed the events as non-serious. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Body temperature', 'Dizziness', 'Dyspnoea', 'Headache', 'Heart rate', 'Hypoaesthesia oral', 'Lip disorder', 'Musculoskeletal stiffness', 'Paraesthesia', 'Pyrexia', 'Tachycardia']",UNK,PFIZER\BIONTECH, 936341,LA,74.0,F,"Headache; Sore arm; Vomiting; Diarrhea; Chills; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO142), via an unspecified route of administration in left arm, on 04Jan2021 at 10:45, at a single dose, for COVID-19 immunization. The patient's medical history included arrhythmia, right shoulder reverse replacement, and fusion at L5S4. The patient's concomitant medications included metoprolol tartrate, digoxin, levothyroxine, and montelukast sodium (MONTEL). The patient previously took codeine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 04Jan2021 at 3:30 PM, the patient experienced headache, sore arm, vomiting, diarrhea, and chills. The events were considered non-serious. No treatment received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,; ; ; MONTEL,,Medical History/Concurrent Conditions: Arrhythmia; Fusion of vertebra; Reverse shoulder replacement,,,"['Chills', 'Diarrhoea', 'Headache', 'Pain in extremity', 'Vomiting']",1,PFIZER\BIONTECH, 936342,AL,44.0,F,"100.4 low grade fever; chills; arm pain was so bad I could hardly list my arm from the pain; body aches; Extreme arm pain where the injection was given/Minor aches following the injection; headache; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on 04Jan2021 18:15 at SINGLE DOSE for COVID-19 immunization. Medical history included high cholesterol. The patient's concomitant medications were not reported. It was reported that the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since vaccination. On 04Jan2021 18:30, the patient immediately had extreme arm pain where the injection was given and a headache. The next day (05Jan2021), the patient's arm pain was so bad on which she could hardly list her arm from the pain (minor aches following the injection). The patient also had extreme Body aches that night. Twenty-four hours after extreme body aches (06Jan2021), the patient had 100.4 low grade fever and chills for 2 to 3 hours. The patient did not receive any treatment for the events. The patient recovered from the events of low grade fever and chills on 06Jan2021 while the remaining events were in Jan2021 Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,,,Medical History/Concurrent Conditions: High cholesterol,,,"['Body temperature', 'Chills', 'Headache', 'Pain', 'Pyrexia', 'Vaccination site movement impairment', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 936343,FL,43.0,F,"Redness and hard lump at injection site; Redness and hard lump at injection site; Warm to touch; Significant discomfort or pain in right arm; Rash on face and neck; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in right arm, on 05Jan2021 at 07:30, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to shellfish, dust mites, cats, cockroach dander, grass, trees, and pollen. The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 05Jan2021, the patient experienced redness and hard lump at injection site, warm to touch (no site reported), significant discomfort or pain in right arm, and rash on face and neck. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Allergic to cats; Allergy to plants; Cockroach allergy; House dust mite allergy; Seasonal allergy; Shellfish allergy,,,"['Feeling hot', 'Pain in extremity', 'Rash', 'Vaccination site erythema', 'Vaccination site mass']",1,PFIZER\BIONTECH, 936344,PA,63.0,F,"Sore right arm; This is a spontaneous report from a contactable nurse, the patient. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK 9231, via an unspecified route of administration in the right arm on 31Dec2020 at 14:30 (at the age of 63-years-old) as a single dose for COVID-19 vaccination. Medical history included hypothyroidism, hypertension, high cholesterol, penicillin allergy; all from unknown dates and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included valsartan, levothyroxine/liothyronine (NP THYROID), simvastatin, vitamin B, vitamin c [ascorbic acid], colecalciferol (VITAMIN D). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 01Jan2021 at 12:00, the patient experienced a sore right arm. Treatment was not received for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the sore right arm was resolved on Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,NP THYROID; ; ; ; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: High cholesterol; Hypertension; Hypothyroidism; Penicillin allergy (known allergies: Penicillin),,,['Pain in extremity'],1,PFIZER\BIONTECH, 936345,,,F,"She states that she is experiencing body aches; This is a spontaneous report from a contactable Other Health Professional (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number was not reported, via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is a 55-year-old female patient assistant who received the COVID-19 vaccine yesterday, on 05Jan2021. She stated that she was experiencing body aches with outcome of unknown in Jan2021. She would like to know if taking TYLENOL is permitted after receiving the vaccine. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/01/2021,,UNK,,,,,,['Pain'],UNK,PFIZER\BIONTECH, 936346,FL,30.0,F,"had a positive Covid test after receiving the vaccine; had a positive Covid test after receiving the vaccine; This is a spontaneous report from a contactable nurse (patient) via a Pfizer Sponsored program, Pfizer First Connect. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EH9899, intramuscular in the left arm, on 18Dec2020 at 0.3 mL, single dose for COVID-19 immunization. Medical history included was none. There were no concomitant medications. The patient had a positive Covid test after receiving the vaccine with outcome of unknown. It was reported that the patient got the first dose of the vaccine on 18Dec2020, and tested positive on 28Dec2020 due to some exposure. She asked for any recommendations on the second dose whether or not she could get it. She is scheduled to get it this weekend. The reporter considered the event as non-serious and unrelated to the use of the vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/28/2020,10.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 936347,GA,54.0,F,"severe dizziness; nausea; vomiting; headache; Vertigo type symptoms; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELU140), via an unspecified route of administration on 21Dec2020 11:00 in right arm at single dose for COVID-19 immunization. Medical history included vertigo from 2015 to an unknown date. There were no concomitant medications. On 29Dec2020 19:00, one week after vaccination, the patient experienced severe dizziness, nausea, vomiting and headache that continues and seemed to be severe vertigo type symptoms. No treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in a Public Health Clinic/Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/29/2020,8.0,OTH,,,Medical History/Concurrent Conditions: Vertigo,,,"['Dizziness', 'Headache', 'Nausea', 'Vertigo', 'Vomiting']",UNK,PFIZER\BIONTECH, 936348,TX,21.0,M,"headache; chills; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) intramuscular (right deltoid) on 05Jan2021 at 13:00 at a single dose, for COVID-19 prophylaxis. Patient has no relevant medical history. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular (left deltoid) on 15Dec2020, at 13:00 for COVID-19 immunization. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient received the second dose of his COVID-19 vaccine yesterday on 05Jan2021. He said that he had no side effects with the first dose except for injection site pain. He received the first dose on 15Dec2020. After receiving the second dose, he has a headache, chills, and muscle aches. He had more symptoms than he had with the first dose. His symptoms started last night and continued this morning. Headache started around 02:00 06Jan2021 while chills started around 22:00 on 05Jan2021. He stated that the chills resolved sometime in the early morning 06Jan2021. Muscle aches started around 22:00 05Jan2021. Patient reported that both of his COVID-19 vaccines had the same lot number. The patient did not require emergency room visit. Patient received ibuprofen, naproxen, and acetaminophen for his headache and muscle aches. Outcome of the event chills was recovered on 06Jan2021, while for other events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH,OT 936349,,,F,"I just went and got my covid test done with a sore throat; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable nurse (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/batch number and expiry date unknown), via an unspecified route of administration on 16Dec2020 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received her first dose of the COVID vaccine on 16Dec2020, stated that her boyfriend just tested positive. She stated, ""I just went and got my covid test done with a sore throat"". She wanted to confirm if she can receive the second dose and also asked if there is a problem with delaying the second dose of the vaccine. The patient underwent lab tests and procedures which included Covid test: unknown results on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,,,UNK,,,,,,"['Oropharyngeal pain', 'SARS-CoV-2 antibody test']",1,PFIZER\BIONTECH, 936355,WA,48.0,F,"mild brain fog-feeling ""stupid"" and struggling with connections, like not picking up on humor immediately, trying to put things away in the wrong place/ ""stupid"" with brain fog that I called in; mild fatigue; mild intermittent headache; mild intermittent headache/ only mild joint ache in knees; This is a spontaneous report from a contactable other health care professional. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 04Jan2021 11:30 at single dose at right arm for COVID-19 immunization. Medical history included non-Hodgkins lymphoma from 1995, invasive ductal carcinoma 2009 with breast reconstruction; phrenic nerve paralysis left side; cardiomyopathy. Concomitant medications included beclometasone dipropionate (QVAR), and metoprolol. On 04Jan2021 15:30, noted starting around 4 hours after vaccine, the patient experienced mild fatigue, mild intermittent headache, mild intermittent ache in knee joints. The patient was unsure if they were vaccine related but became a little more intense as the evening went on (next 5 hours) but still overall were mild, but enough for the patient to determine they seemed related to the vaccine. Also noted about 6 hours after vaccine, on 04Jan2021 17:30, mild brain fog-feeling ""stupid"" and struggling with connections, like not picking up on humor immediately, trying to put things away in the wrong place. The patient went to bed about 8-9 hours after vaccine (8pm). The patient usually gets up at 4:45-5am. She was so tired the next morning and ""stupid"" with brain fog that she called in. She wasn't uncomfortable per se, no headache the next day, only mild joint ache in knees, fatigue and brain fog. No serious reactions. The outcome of the events was recovered on an unspecified date in Jan2021. The patient did not receive treatment for the events. Information about lot/ batch number is requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,QVAR;,,Medical History/Concurrent Conditions: Breast reconstruction; Cardiomyopathy; Invasive ductal breast carcinoma; Non-Hodgkin's lymphoma; Phrenic nerve paralysis,,,"['Arthralgia', 'Fatigue', 'Feeling abnormal', 'Headache']",UNK,PFIZER\BIONTECH,OT 936363,PA,39.0,F,"intense chills; uncontrollable shaking; Could not get warm; Had trouble walking; Had trouble sleeping; Felt warm rest of night; Did not have a chance to take my temperature but probably had a fever; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration, at the left arm on Jan2021 09:15 at a single dose for COVID-19 immunization at a hospital. Medical history included obesity. Concomitant medications included ibuprofen (ADVIL), methylphenidate & unspecified multivitamins. The patient previously took tetracycline and experienced allergies. On 06Jan2021 01:00, the patient woke up with intense chills and uncontrollable shaking, could not get warm or stop the shaking, had trouble walking or holding a glass of water shaking was so intense. Patient took ibuprofen helped and symptoms improved after 1-2 hours. The patient also had trouble sleeping and felt warm rest of night. Did not have a chance to take her temperature but probably had a fever. Overslept and missed first work meeting. Patient felt ok by 06Jan2021, 9:30. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient recovered from the events on 06Jan2021, 9:30.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/06/2021,5.0,PVT,ADVIL;,,Medical History/Concurrent Conditions: Obesity,,,"['Chills', 'Feeling cold', 'Feeling hot', 'Gait disturbance', 'Insomnia', 'Pyrexia', 'Tremor']",1,PFIZER\BIONTECH, 936366,,,M,"He tested positive last Tuesday for SARS-Cov-2; He tested positive last Tuesday for SARS-Cov-2; This is a spontaneous report from a Pfizer Sponsored Program, Pfizer First Connect via a contactable other health professional (HCP) (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested positive last Tuesday (05Jan2021) for SARS-Cov-2 and the patient wanted to know if he could receive his second dose of vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,01/05/2021,18.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 936373,MA,,F,"she received the COVID-19 vaccine and the next day she tested positive for the viral infection; she received the COVID-19 vaccine and the next day she tested positive for the viral infection; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program Pfizer First Connect. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient was tested on 02Jan2021, and did not get the results till 06Jan2021 and tested positive. The patient wanted to know if she could have any side effects if she received the COVID-19 vaccine and the next day she tested positive for the viral infection. She is unsure of when she contracted the infection. The outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/01/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 936379,CA,37.0,F,"chest tightness; palpitations; elevated heart rate; fatigue; This is a spontaneous report from a contactable Other HCP. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. Medical history included Dermatographia. The patient is allergic to Penicillin, lactose, Cephalosporins and Beepen-VK. There were no concomitant medications. Seventy two hours after the vaccine was given the patient had an elevated heart rate, chest tightness and fatigue. Are this consistent with the vaccine. She does not have a history of elevated heart rate or palpitations. She checked her heart rate with her Apple watch and sent in a strip to the doctor. The doctor is concerned and is asking if this is related. She went to the ER to make sure she was ok but was not admitted. Outcome of event heart rate increased as recovered on 05Jan2021, of fatigue was not recovered, of others was recovering. Information about Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of elevated heart rate, chest tightness, palpitations and fatigue due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including 12-lead EKG , counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,UNK,,,Medical History/Concurrent Conditions: Dermatographia; Lactose intolerance; Penicillin allergy,,,"['Chest discomfort', 'Fatigue', 'Heart rate increased']",UNK,PFIZER\BIONTECH, 936388,NM,47.0,M,"if a patient experienced an allergic reaction to the first dose is there anything prophylactically needing to be done when administering the second dose of the Covid vaccine; delayed hyper sensitive reaction; Angioedema; Urticarial rash; This is a spontaneous report from a contactable other hcp. A 47-years-old male patient received first dose of bnt162b2 (BNT162B2), unknown on 18Dec2020 (lot number: EK5730) at SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller is a Physician Assistant. Caller states that she is calling about the Covid Vaccine. She had a patient received his first dose of the vaccine on Friday 18Dec2020, 3 days later on 21Dec2020 he had an urticarial rash that persisted, The urticarial rash was treated with prednisone and resolved by 27Dec2020, it has not reoccurred. The allergist said it was a delayed hyper sensitive reaction that was Prompted by the immune simulation from the vaccine. The Patient was treated for the urticaria. Caller would like to know if a patient experienced an allergic reaction to the first dose is there anything prophylactically needing to be done when administering the second dose of the Covid vaccine? Caller is very upset and frustrated and stating she wants to speak to someone that is a clinician with the clinical trial team who can give her recommendations for a specific patient. Caller asks if they should do Prophylaxis with antihistamines for the second dose. He did not have anaphylaxis but he had angioedema. Caller states that she did a Vaers report on 22Dec2020, but no one contacted her. He started taking Zyrtec and Vistaril. The Allergist said it was fine and he will still need the 2nd Booster Dose. The Angioedema started on 22Dec2020, it was also treated with prednisone, in addition to being administered Benadryl IM, and Vistaril. The outcome of the event urticarial rash was recovered on 27Dec2020 and Angioedema was recovered on 22Dec2020. No follow-up attempts are needed; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the angioedema and the other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including serum tryptase level and complement panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/21/2020,3.0,UNK,,,,,,"['Angioedema', 'Type IV hypersensitivity reaction', 'Urticaria']",1,PFIZER\BIONTECH, 936392,PA,37.0,F,"Angioedema; Tongue numb observer notified about 10 minutes after vaccine, then tongue and Lower lips numb; tachycardia with throat tightness; tachycardia with throat tightness.; This is a spontaneous report from a contactable nurse (patient). The 37-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot number: EK9231), unknown on 05Jan2021 07:45 at SINGLE DOSE on left arm for COVID-19 immunisation. The patient is not pregnant. No covid tested post vaccination. Medical history included Idiopathic angioedema, HTN, PCOS, Allergies to medications, food, or other products: Latex, penicillin, coconut. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included spironolactone (ALDACTONE), fexofenadine hydrochloride (ALLEGRA), hydrochlorothiazide, amlodipine besilate (NORVASC). The patient did not take other vaccine in four weeks. The patient experienced Angioedema event occurred approximately 18 hrs later with repeat of treatment in ER on 06Jan2021, tongue numb observer notified about 10 minutes after vaccine, then tongue and lower lips numb on 05Jan2021 08:00, taken to ER became tachycardia with throat tightness on 05Jan2021 08:00. EPIPEN administered, benadryl and prednisone (steroids), and famotidine administered along with a saline bolus. The outcome of the events was recovered. No follow-up attempts are needed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the angioedema and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including complement levels, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,ALDACTONE [SPIRONOLACTONE]; ALLEGRA; ; NORVASC,,"Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?: Yes); Fruit allergy (Allergies to medications, food, or other products: Latex, penicillin, coconut); Hypertension; Idiopathic angioedema; Latex allergy (Allergies to medications, food, or other products: Latex, penicillin, coconut); Penicillin allergy (Allergies to medications, food, or other products: Latex, penicillin, coconut); Polycystic ovary",,,"['Angioedema', 'Hypoaesthesia oral', 'Tachycardia', 'Throat tightness']",1,PFIZER\BIONTECH, 936396,VA,44.0,M,"extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple line; BP was 180/110 / BP stayed around 160/100; felt an ""amped"" feeling; felt flush; uncomfortable; This is a spontaneous report from a contactable healthcare professional. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), dose number 1, intramuscularly on 21Dec2020 14:00 at a single dose on the right arm for COVID-19 immunization. Medical history included gluten allergy with causes dermatitis herpetiformis, osteoporosis, and fibromyalgia. The patient previously took Benadryl and experienced allergies. Concomitant medications were not reported. The patient reported that immediately after receiving vaccine on 21Dec2020, he felt an ""amped"" feeling and felt flush. It was uncomfortable but not alarming at first. About ten minutes after shot, he started to have extremely bad dry mouth. He went back to work, but he went back downstairs after feeling like he was getting seriously ill and his lips were going numb. His BP was 180/110. The facial numbness went away but his BP stayed around 160/100. He was asked to go to ER, but he refused because he would have to pay for it and he was feeling better. He also noticed after going back upstairs that he had a rash from his neck to his nipple line. The doctor asked for Benadryl, but he was not given due to possible Benadryl allergy. He went home and his BP returned to normal 2 hours later. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested for COVID-19 since the vaccination. The outcome of the events was recovered in 21Dec2020 for blood pressure increased and facial numbness, and recovered on an unspecified date for the other events. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the BP increased and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Dermatitis herpetiformis; Fibromyalgia; Gluten sensitivity; Osteoporosis,,,"['Agitation', 'Blood pressure increased', 'Discomfort', 'Dry mouth', 'Flushing', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Immediate post-injection reaction', 'Malaise', 'Rash']",1,PFIZER\BIONTECH,OT 936397,WA,54.0,F,"crystals in her urine; muscle pain; joint pain; flu like symptoms/feeling like she has the flu; having no energy; feeling tired/Tiredness; kidney stone; pain in her back; did not feel good; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0140) intramuscular on 31Dec2020 16:00 at a single dose on left arm for Covid-19 prophylaxis. Medical history included rheumatoid arthritis. There were no concomitant medications. The patient wanted to know if she could receive the second dose of the COVID-19 vaccine if she presented the following side effects with the first shot: feeling tired/tiredness on 02Jan2021; having no energy on 03Jan2021; muscle pain, joint pain, and flu like symptoms/feeling like she has the flu, on 04Jan2021. She went to work on Monday and has taken the last couple of days off because she did not feel good on Jan2021. She did have rheumatoid arthritis, but it was different and has not been like this. She went to the doctor on Monday after she got off of work and thought at first maybe she had a UTI; treated herself with AZO, but had a urinalysis that was negative on an unspecified date. She was told some of the pain in her back might have been a kidney stone on Jan2021 because they found crystals in her urine on 04Jan2021, but she did not know about that. She noticed having no energy on Sunday. She wanted to know if it was recommended that she get the second vaccine since she was having side effects. The events required a visit to physician office and did not require a visit to Emergency Room. Prior vaccinations within 4 weeks was noted as none. Family medical history relevant to the events (AE) was noted as none.The outcome of the events of feeling tired/tiredness was not recovered; of having no energy, muscle pain, joint pain, flu like symptoms/feeling like she has the flu was recovering; of the rest of events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,OTH,,,Medical History/Concurrent Conditions: Rheumatoid arthritis,,,"['Arthralgia', 'Asthenia', 'Back pain', 'Crystal urine present', 'Fatigue', 'Feeling abnormal', 'Impaired work ability', 'Influenza like illness', 'Myalgia', 'Urine analysis abnormal']",1,PFIZER\BIONTECH,OT 936417,AZ,35.0,F,"Left Bell's palsy/left side of face, inability to raise left eyebrow; numbness and paresthesia of tongue; numbness and paresthesia of tongue; pain in left upper arm between elbow and shoulder; tachycardia; elevated blood pressure; This is a spontaneous report from a contactable physician. A 35-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscular at arm left on 31Dec2020 at single dose for covid-19 immunization. The vaccine was administered at other (as reported). Medical history included asthma (Allergy induced asthma). Concomitant medication within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC) from Dec2020 at 10mg daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020, the patient experienced Left Bell's palsy, numbness and paresthesia of tongue, left side of face, inability to raise left eyebrow, pain in left upper arm between elbow and shoulder, tachycardia, elevated blood pressure. The adverse events result in emergency room/department or urgent care. The patient received treatment for the adverse events which included Prednisone 20mg daily, Valacyclovir 1000mg twice a day. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the Bell's palsy and other reported events due to temporal relationship. However, the Bell's palsy may possibly represent a concurrent medical condition. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including viral serologies, and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,UNK,ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Allergic asthma,,,"['Blood pressure increased', 'Facial paralysis', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Injection site pain', 'Mobility decreased', 'Paraesthesia', 'Paraesthesia oral', 'Tachycardia']",1,PFIZER\BIONTECH,OT 936419,AZ,51.0,F,"Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; This is a spontaneous report from a contactable Nurse (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899), intramuscularly on 28Dec2020 14:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was hospital. Medical history included migraine from an unknown date. Concomitant medication included erenumab aooe (AIMOVIG), estradiol, diphenhydramine hydrochloride (BENADRYL), trazodone hydrochloride (TRAZODON). No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site on 28Dec2020 15:00. Patient received Antibiotics, steroids epi as treatment for the adverse events. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of event migraine was recovered in Jan2021, other events was recovered on an unknown date. The events were reported as non-serious.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Vaccination site cellulitis, shortness of breath, stridor and migraine, due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,AIMOVIG; ; BENADRYL; TRAZODON,,Medical History/Concurrent Conditions: Migraine,,,"['Condition aggravated', 'Dyspnoea', 'Injection site cellulitis', 'Migraine', 'Stridor']",1,PFIZER\BIONTECH,OT 936423,FL,,F,"to get Botox injection for her Dystonia; got her 1st dose of Covid vaccine last 04Jan and was scheduled to have her 2nd dose on 22Jan; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer(patient) reported that a 62-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got her 1st dose of Covid vaccine last 04Jan2021 and was scheduled to have her 2nd dose on 22Jan2021, but she had an appointment 2 days prior this to get botulinum toxin type a (BOTOX) injection for her Dystonia. The patient wanted to know if it's ok for her to get 2nd dose of Covid vaccine after getting botulinum toxin type A. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,,,UNK,,,,,,['Unevaluable event'],1,PFIZER\BIONTECH, 936439,,,F,"she tested positive 5 days after taking the first COVID19 Vaccine dose; she tested positive 5 days after taking the first COVID19 Vaccine dose; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive 5 days after taking the first COVID-19 vaccine dose. Outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 936446,NY,,M,"received first dose of covid vaccine on 19Dec2020 tested positive on 31Dec2020; received first dose of covid vaccine on 19Dec2020 tested positive on 31Dec2020; This is a spontaneous report from a contactable other HCP (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 19Dec2020 at the first single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first dose of covid vaccine on 19Dec2020 tested positive on 31Dec2020. The outcome of events was unknown. Information about Lot/Batch has been requested.; Sender's Comments: A causal association between reported event and BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/31/2020,12.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 936452,LA,,F,"tested positive for covid19; tested positive for covid19; This is a spontaneous report from a contactable nurse (patient). A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received vaccine 1st dose on 21Dec2020 and on 29Dec2020 she tested positive for covid19. She is coming up on 2nd dose on Friday (will be out of quarantine on the same day), she asked if she should get the vaccine. Her primary care physician advised her not to receive, within 30 days because there had been reports of people having reactions (ie: high fevers) to the vaccine. If she has a high fever she can't go to school. She asked if waiting 90 days make the vaccine not as effective and if she need to restart the series. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Test positive for covid19 found 7 day following the vaccination, no adequate effect of the suspect vaccine thus could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/29/2020,8.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 936456,,35.0,F,"collapse/rapid progression of symptoms; hypotension/rapid progression of symptoms; respiratory distress with stridor; respiratory distress with stridor; dizziness/rapid progression of symptoms; not limited to abdominal pain/rapid progression of symptoms; blood pressure abnormality/rapid progression of symptoms; chest pain/rapid progression of symptoms; drooling/rapid progression of symptoms; increased swelling/rapid progression of symptoms; wheezing; dyspnea and increased work of breathing; skin changes; tongue swelling and vomiting; tongue swelling and vomiting; This is a spontaneous report from a non-contactable other health professional. A 35-year-old female patient (Age at vaccination: 35) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15 minute waiting period after the injection, the patient began to experience dizziness. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality, chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea and increased work of breathing, skin changes, tongue swelling and vomiting. Treatment included: no therapy. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the collapse, hypotension, respiratory distress and other reported events due to temporal relationship. There is very limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including BP measurements, chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Blood pressure abnormal', 'Dizziness', 'Hypotension']",UNK,PFIZER\BIONTECH, 936457,,,F,Escherichia Coli infection; This is a spontaneous report from a non-contactable consumer (daughter) from a Pfizer sponsored program Pfizer First Connect. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter's mother has Escherichia Coli infection and is taking Nitrofurantoin antibiotic (Macrodantin). Asked if it is safe to take the second dose of the vaccine while on antibiotic. Caller asking if we could update info regarding antibiotic as even her doctor does not have info on this. Saying that even her doctor is unsure as Pfizer should know information regarding this more than her doctor. Treatment for event was Nitrofurantoin antibiotic (Macrodantin). Outcome of event was unknown. No follow up attempts are possible; Information about lot/batch number cannot be obtained.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Escherichia infection'],1,PFIZER\BIONTECH, 936470,,,F,"tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested positive for Covid on 22Dec2020. She wanted to know if there is any more information on receiving the second dose after testing positive. The outcome of the event was unknown. Information on the Lot/batch number has been requested.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (in this case 2 days). However, a causal relationship between event ""tested positive with Covid "" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/22/2020,2.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 936474,,,F,"she received the Pfizer-BioNTech Covid-19 Vaccine .She said she tested positive for Covid-19 after being exposed to someone infected with the virus last Christmas; she received the Pfizer-BioNTech Covid-19 Vaccine .She said she tested positive for Covid-19 after being exposed to someone infected with the virus last Christmas; after being exposed to someone infected with the virus; This is a spontaneous report from a contactable Physician (patient). A female patient of an unspecified age receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient she received the Pfizer-BioNTech Covid-19 Vaccine on 18Dec2020. She said she tested positive for Covid-19 after being exposed to someone infected with the virus last Christmas (25Dec2020). Now, she wanted to know if she can still take the 2nd dose. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between reported event and BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/25/2020,7.0,UNK,,,,,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 936478,MT,64.0,F,"tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer received from a Pfizer-sponsored program Pfizer First Connect. A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899, expiry date Mar2021, NDC 59267-1000-1), intramuscular in right arm on 18Dec2020 11:45 at a single dose as prevention. The vaccine was administered in the hospital. Medical history included ongoing cardiomyopathy diagnosed about 32 years ago and had pacemaker defibrillator Placed about 12 years ago. There were no concomitant medications. She was supposed to get the second dose of the Covid vaccine but she was positive for Covid. She found out she was positive for covid on Monday 04Jan2021 after she had a nasal swab test on 02Jan2020. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,01/04/2021,17.0,PVT,,Cardiac pacemaker insertion (Placed about 12 years ago.); Cardiomyopathy (Diagnosed about 32 years ago.),,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH,OT 936499,,,F,"Bell's Palsy; developed flu like symptoms; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age (reported as 32-40) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in 2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient developed side effects side effects from first vaccine, Bell's palsy 4 days after vaccination (Dec2020) which lasted for 2 weeks and flu like symptoms (Dec2020) which also lasted 2 weeks. The events outcome was unknown. The patient was receiving 2nd dose on 06Jan2021, the reporter asked any information regarding this? Information on the lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between event Bell's palsy and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/01/2020,,UNK,,,,,,"['Facial paralysis', 'Influenza like illness']",1,PFIZER\BIONTECH, 936513,CA,47.0,F,"Fatigue; tested positive after receiving Covid-19 vaccine; tested positive after receiving Covid-19 vaccine; severely congested; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported that a 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, Expiry Date: Mar2021) via an unspecified route of administration at right deltoid on 20Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing severe asthmatic diagnosed as a child. There were no concomitant medications. Patient (a front line worker) is Grief Counselor. She tested positive after receiving BNT162B2 on 29Dec2020. She was supposed to get the second dose on 10Jan2021. She was having fatigue since 01Jan2021 and was severely congested since 26Dec2020. She was asking if she should get the second dose. The outcome of the events severely congested and fatigue was recovering, of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/26/2020,6.0,UNK,,Asthmatic (diagnosed as a child),,,,"['Fatigue', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 936525,,,F,"recently got vaccinated unwillingly knowing she had Covid; recently got vaccinated unwillingly knowing she had Covid; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for herself. A female patient of an unspecified age received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient recently got vaccinated unwillingly knowing she had covid on an unspecified date. The patient wanted to known if she should get her second dose still and in the same timely manner. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 cannot be completely excluded for reported event.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Unevaluable event'],1,PFIZER\BIONTECH, 936539,PA,,F,"she received the first dose of the vaccine on the 22nd of December and tested positive on the 28th; she received the first dose of the vaccine on the 22nd of December and tested positive on the 28th; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer(patient) reported that a female patient of an unspecified age received first dose BNT162B2, via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on the 22nd of December and tested positive on the 28Dec2020, she was scheduled to get the 2nd dose on Jan 12th. The reporter wanted to know if it was safe for her to take the 2nd dose. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/28/2020,6.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 936550,,,U,"testing positive for COVID on nasal swab after first dose of COVID vaccine; testing positive for COVID on nasal swab after first dose of COVID vaccine; This is a spontaneous report from a non-contactable pharmacist. A patient of unspecified age and gender received 1st dose of BNT162B2 (reported as COVID vaccine), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for Covid on nasal swab after first dose of Covid vaccine on an unspecified date with outcome of unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. Pfizer is a marketing authorization holder of COVID vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID vaccine has submitted the same report to the regulatory authorities.; Sender's Comments: The reported testing positive for Covid on nasal swab after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 936551,,,F,"She thinks there has been more anaphylactic reactions than usual and said that a physician female friend had experienced one; This is a spontaneous report from a non-contactable Other Health Professional via Pfizer sales representative. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. During a conference call, (Name) mentioned that she thinks there has been more anaphylactic reactions than usual and said that a physician female friend had experienced one. It was unclear whether it was after a Pfizer or Moderna vaccine. She did mention that her friend recovered without any issues. Outcome of event was recovered on an unspecified date. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,['Anaphylactic reaction'],UNK,PFIZER\BIONTECH, 936570,OK,68.0,F,"Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine), via an unspecified route of administration on an unspecified date at a single dose in left arm for COVID-19 immunization. Medical history included ongoing rheumatoid arthritis, open heart surgery had this done a year ago, knee replacement, and hip replacement. Concomitant medications included patient took a lot of different medications, but no additional details provided. The test done on Saturday 02Jan2021 and on Sunday 03Jan2021, she got the results that she was positive for COVID. Clinical details: She received the first dose of her COVID vaccine, and she will be due for her second dose on Saturday. However, she tested positive for COVID after getting her first dose. The doctor informed her she should have a COVID infusion. She took the COVID infusion and now after getting the infusion she is told she is not able to get her second dose of the COVID vaccine for 60-90 days. She is not sure what to do. She cannot remember the date she got the COVID vaccine, she knew she is due for her second one on Saturday. She received the COVID infusion this morning, originally she was told she would be able to have a second shot even after getting the COVID infusion. Now they are saying she cannot have the next dose on Saturday. She was told later she would have to wait two weeks. Then she was told she would have to possibly wait 90 days. She was thankful for the vaccine because even though she tested positive it probably kept her from dropping dead. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/02/2021,,UNK,,RA,Medical History/Concurrent Conditions: Hip replacement; Knee replacement; Open heart surgery (Had this done a year ago),,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 936582,,,F,"got Covid/She tested positive for SARS-Cov-2 04JAN2021; got Covid; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient indicated she received her first dose of vaccine 21Dec2020. She tested positive for SARS-Cov-2 04Jan2021. She was asking how she ""got Covid"" and if she should receive the second dose. The outcome of the event was unknown. Information on Lot/Batch number has been requested.; Sender's Comments: The reported tested positive for SARS-Cov-2 after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,01/04/2021,14.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 936609,,27.0,F,"The day after vaccine administration, pt was still experiencing vertigo, spinning and headache.; The day after vaccine administration, pt was still experiencing vertigo, spinning and headache.; This is a spontaneous report from a non-contactable other healthcare professional (hcp). A 27-year-old female patient receive first dose of bnt162b2 (Pfizer BioNTech COVID vaccine, lot number: EL0140), intramuscularly on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. There is unknown if any other vaccine received in four weeks. The patient experienced the day after vaccine administration, patient was still experiencing vertigo, spinning and headache, all on 31Dec2020 the day after vaccine administration. The outcome of events was unknown. This is a non-serious report. It's unknown if patient was diagnosed with COVID-19 or tested for COVID-19 since the vaccination. The adverse did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,UNK,,,,,,"['Headache', 'Vertigo']",1,PFIZER\BIONTECH,OT 936612,CA,51.0,F,"anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation. Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip. Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin, morphine and experienced drug hypersensitivity. The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,; ; LEVOTHROID; WELLBUTRIN,,Medical History/Concurrent Conditions: ADHD; Adrenal insufficiency; Congenital hip dislocation; Hypermobility syndrome; Hypothyroidism; Paroxysmal supraventricular tachycardia,,,"['Anaphylactic reaction', 'Chills', 'Cough', 'Dizziness', 'Headache', 'Hypoaesthesia', 'Oropharyngeal pain', 'Pharyngeal paraesthesia', 'Pruritus', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tachycardia', 'Throat tightness', 'Wheezing']",1,PFIZER\BIONTECH, 936618,AZ,36.0,F,"Soreness at injection site started at 1600 Body aches, headache, and low grade fever woke me up around 0100",Not Reported,,Yes,Not Reported,,Not Reported,U,01/11/2021,01/11/2021,0.0,PUB,"Magnesium, fish oil, vitamin b12, maca powder, CoQ10, biotin",None,None,,None,"['Headache', 'Injection site pain', 'Pain', 'Pyrexia', 'Sleep disorder']",2,PFIZER\BIONTECH,SYR 936619,MT,,U,"Patient with Covid between their first and second doses of the Covid vaccine; Patient with Covid between their first and second doses of the Covid vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable Pharmacist reported similar events for 2 patients. This is the 2nd of 2 reports. A patient of an unspecified age and gender received the first dose of BNT162B2 (Pfizer/BioNTech Covid-19 vaccine) on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got Covid between first and second doses of the Covid vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (got COVID between first and second doses) with BNT162b2 can not be fully excluded.,Linked Report(s) : US-PFIZER INC-2021011515 same reporter/drug/AE, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 936621,MT,,U,"patient with covid between their first and second doses of the covid vaccine; patient with covid between their first and second doses of the covid vaccine; This is a spontaneous report from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A contactable pharmacist reported similar events for two patients. This is the first case out of 2 cases. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: Apr2021, NDC#59267-1000-1), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient with Covid between the first and second doses of the Covid vaccine on an unspecified date. The reporting pharmacist wanted to know if the patients with covid between their first and second doses of the covid vaccine what their risk would be, Reportedly 2 different patient. The outcome of the events was unknown.; Sender's Comments: The association between the event lack of effect (COVID between first and second dose) with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021011471 same reporter/drug/event, different patient..",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 936625,CA,,U,"tested positive and also received the vaccine from COVID-19; tested positive and also received the vaccine from COVID-19; This is a spontaneous report from a Pfizer sponsored program. This contactable physician reported similar events for the physician herself and a patient. This is the second report, the patient report of 2 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The physician reported there was another person in her clinic that tested positive and also received the COVID vaccine on an unspecified date with outcome of unknown. The information on the batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021000799 Same reporter, same drug, different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 936642,,,U,"did develop COVID that week probably symptoms in general by 25Dec/probably infected whenever got the vaccine; did develop COVID that week probably symptoms in general by 25Dec/probably infected whenever got the vaccine/I don't feel very well right now; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received 1st vaccine on 21Dec2020. The patient did develop COVID that week probably symptoms in general by 25Dec2020. She was probably infected whenever she got the vaccine and the patient was scheduled to have second vaccine on 11Jan2021 which was next Monday and the patient was still sick, should the patient delayed that. The patient also did not feel very well on an unknown date (""right now""). The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/25/2020,4.0,UNK,,,,,,"['COVID-19', 'Malaise']",1,PFIZER\BIONTECH, 936647,,,M,"had covid after his first dose; had covid after his first dose; headaches; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable Physician. A male patient of an unspecified age received his first single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) on an unspecified date in Dec2020 for Covid-19 immunization. The patient previously had Covid in Apr2020. Concomitant medications were not reported. After his first dose of vaccine, in Dec2020, the patient had Covid and headaches. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported ""had Covid"" after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,Medical History/Concurrent Conditions: COVID-19 (Caller mentioned he had covid last April.),,,"['COVID-19', 'Headache']",1,PFIZER\BIONTECH, 936648,MI,,F,"Got the first dose of the vaccine on 23Dec2020, this week the patient was tested positive for COVID; Got the first dose of the vaccine on 23Dec2020, this week the patient was tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable other healthcare professional (HCP) (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the first dose of the vaccine on 23Dec2020, this week the patient was tested positive for COVID in Jan2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported tested positive for COVID after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/01/2021,9.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 936649,,,F,"she tested positive in the middle; she tested positive in the middle; This is a spontaneous report from a contactable female consumer (patient) via a Pfizer-sponsored program . A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at first single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller was asking if it was safe for her to get the second dose, she had the 1st dose on the 16Dec2020 and scheduled for the second dose today (reported on 06Jan2021), however she tested positive in the middle. Outcome of the event was unknown. information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 936650,VA,,M,"tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for himself via a Pfizer-sponsored program Pfizer First Connect. A male patient of an unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not reported) via an unspecified route of administration on 21Dec2020 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive for COVID-19 on 28Dec2020 and he was wondering if he was still able to receive the second dose of the vaccine. The outcome of the event was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: The reported tested positive for COVID-19 after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/28/2020,7.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 936666,IL,47.0,F,"Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness; Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization. There were no known medical history or concomitant medications. The patient previously received the first dose of BNT162B2 on 18Dec2020 (Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10 minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN). Later on 08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen (MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Anaphylactic reaction', 'Chest discomfort', 'Dizziness', 'Dyspnoea', 'Erythema', 'Flushing', 'Headache', 'Hyperhidrosis', 'Rash', 'Tachycardia', 'Urticaria']",2,PFIZER\BIONTECH, 936676,PA,67.0,F,"arm sore / pain in right arm; weakness in right arm; Today patient was in a lot of pain / worse during lateral movements or / raises her arm above her head; weakness are worse during lateral movements / raises her arm above her head; right arm was hot for 3 days; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number MT7C9, expiry date unknown) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis. Previously administered products included Pneumonia vaccine (got last year). Concurrent medical conditions included ileo-anal pouch (J pouch) and colon cancer. On 11th September 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 24th November 2020, 74 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain and weakness. On an unknown date, the patient experienced pain in arm, weakness of arms and extremities hot feeling of. On an unknown date, the outcome of the pain in arm and weakness of arms were not recovered/not resolved and the outcome of the extremities hot feeling of was recovered/resolved and the outcome of the pain and weakness were unknown. It was unknown if the reporter considered the pain in arm, weakness of arms, extremities hot feeling of, pain and weakness to be related to Shingrix. It was unknown if the reporter considered the pain and weakness to be related to Influenza vaccine Quadrivalent 2020-2021 season. Additional details were provided as follows: The patient received 1st dose of Shingrix in her right arm deltoid and a flu shot at the same time in her left arm deltoid. The patient reported right arm sore and hot for 3 days then resolved. The patient reported continued weakness and pain in right arm. The patient does arm exercise reps at the gym with 10 to 12 pound weights and did so last night. On 24th November 2020, the patient was in a lot of pain. The patient stated that the pain and weakness were worse during lateral movements or when she raises her arm above her head. The reporter did not consented to follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,09/11/2020,11/24/2020,74.0,UNK,,Colon cancer; Ileo-anal pouch (J pouch),,,,"['Asthenia', 'Feeling hot', 'Muscular weakness', 'Pain', 'Pain in extremity']",1,GLAXOSMITHKLINE BIOLOGICALS, 936677,NJ,,M,"Neuropathy / is going to receive Shingrix�s 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of neuropathy in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant). The patient was treated with immunoglobulin human normal (Gammagard). On an unknown date, the outcome of the neuropathy was not recovered/not resolved. It was unknown if the reporter considered the neuropathy to be related to Shingrix. Additional information was provided as follows: The reporter stated that a patient who was currently receiving Gammagard because of a neuropathy and the patient was going to receive Shingrix 2nd dose. No other information about the patient�s medical condition was provided and did not have any vaccine information. The reporter consented to follow up. No further information was available.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Neuropathy peripheral'],1,GLAXOSMITHKLINE BIOLOGICALS, 936695,TX,,F,"anaphylactic reaction to an influenza vaccine; Initial information regarding an unsolicited valid serious case was received from a consumer/non-health care professional (Reference number- 00416355) and transmitted to Sanofi on 05-Jan-2021. This case involves female patient of an unknown age who experienced anaphylactic reaction, while she received INFLUENZA VACCINE. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious anaphylactic reaction, (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Reporter was told that the reaction was due to the egg content and informed about components of Flublok. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event was reported as unknown. Information on the batch number was requested.; Sender's Comments: This case concerns female patient of an unknown age who had anaphylactic reaction, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. The patent has a history of egg allergy. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Anaphylactic reaction'],UNK,UNKNOWN MANUFACTURER,OT 936715,PA,24.0,F,"Approx 10-15 post vaccine, employee said she felt lightheaded and like her heart was racing. Within 10 minutes she said she felt difficulty breathing, She then vomited. The observation nurse at the clinic administered Epi Pen and called a Code. The employee was transported to the Emergency Dep't and then to intensive care. She was placed on an Epi drip.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,"Sprintec, QVar ProAir, Prevacid, Respi Click",Unknown,Asthma,,"Sulfa, Neomycin, Bacitracin, Motrin, Shellfish, Cats/Dogs","['Dizziness', 'Dyspnoea', 'Intensive care', 'Palpitations', 'Vomiting']",2,PFIZER\BIONTECH,IM 936735,KY,64.0,F,10 hrs after shot uncontrollable shaking & frezzing cold. 5 hrs later really bad muscle pain in hips & legs. Couldnt stand up. 24hs Later symptoms gone.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,,,,,,"['Arthralgia', 'Dysstasia', 'Myalgia', 'Nasopharyngitis', 'Pain in extremity', 'Tremor']",1,PFIZER\BIONTECH, 936736,NY,,F,A few minutes after Receiving vaccination patient complained of scratchy throat. No other symptoms reported. Pt was seen by urgent care provider and sent home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,unknown,None,None,,None,['Throat irritation'],1,MODERNA,IM 936738,,89.0,M,"loss of consciousness Narrative: Patient received COVID-19 vaccine dose #1 on 1/6/21 w/o complications. Per 1/6/21- 1/9/21 nursing notes, patient did not experience any injection site reactions, denied pain or tenderness at injection site, no dizziness, no n/v, remained afebrile. Around 1/9/21 @1810, patient became acutely nonresponsive after being helped to the edge of bed. Per nurses, he was previously awake/alert, talking and asymptomatic. Patient is DNR/DNI but facility rapid response emergency team called d/t patient's sudden change of condition. Emergency team helped patient into lying position. Per 1/9/21 ICU emergency team note, patient appeared comfortable w/ no palpable radial pulse and had minimal shallow agonal breathing. Pulse ox 94%, HR in 60s per machine. BP unmeasurably low by BP cuffx3. Resident passed at 18:20 pm.",Yes,01/09/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/09/2021,3.0,OTH,,,,,,"['Adenovirus test', 'Blood pressure immeasurable', 'Bordetella test negative', 'Chlamydia test negative', 'Death', 'Enterovirus test negative', 'Human metapneumovirus test', 'Human rhinovirus test', 'Hypopnoea', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Intensive care', 'Loss of consciousness', 'Mycoplasma test negative', 'Polymerase chain reaction', 'Radial pulse abnormal', 'Respiratory syncytial virus test negative', 'SARS-CoV-2 test negative', 'Staphylococcus test negative', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 936739,ME,26.0,F,"Within 1 hour of receiving the vaccine the patient developed asthma symptoms,dizziness, tingling in mouth and swollen tongue. She presented at a walk-in clinic and received Epi-Pen 0.3mg, Solu-Medrol and Benadryl, while there she received 2 additional doses and was transferred to the nearest ED by ambulance. At the ED she received a 4th dose of Epi-Pen 0.3mg and albuterol and DuoNeb treatments. She was admitted for observation. She went home and needed to return within 24 hours to the ED because her lips and tongue started to swell and she turned blue. She subsequently needed 3 additional doses of Epi-Pen over the next 24-48 hours. She has been on Benadryl 50mg every 6 hours and Famodine 20mg until present.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,"DuoNeb, Albuterol, Symbicort, Lexipro, Hydroxychloriqu, Plaquenil, Xeljanz, Methotrexate",,"Asthma, Ankylosing Spondylitis, Bipolar I",,"latex, peanuts, seasonal, enviromental","['Asthma', 'Dizziness', 'Paraesthesia oral', 'Skin discolouration', 'Swollen tongue']",1,MODERNA,IM 936755,TX,53.0,F,Bells Palsy on the right side of face,Not Reported,,Not Reported,Not Reported,,Yes,N,08/15/2020,08/15/2020,0.0,PVT,None,Severe right earache,"Arthritis, earaches/vertigo, lower back pain, bunions, and hay fever/allergies (timothy hay).",,None,"['Acoustic stimulation tests', 'Blood test', 'Electrocardiogram', 'Facial paralysis', 'Magnetic resonance imaging brain']",1,GLAXOSMITHKLINE BIOLOGICALS,SYR 936767,PA,55.0,F,"Approximately 1 - 2 hours after receiving I had numbess and soreness to my neck. A few days later started experiencing tingling, buzzing, weakness and heaviness to my right arm and leg. I reported this to my MS doctor who ordered an MRI of the brain and told me to report to you",Not Reported,,Not Reported,Not Reported,,Yes,N,12/30/2020,01/03/2021,4.0,PVT,vitamin d3 multivitamin calcium fish oil cranberry ambien,,r/o Multiple sclerosis for 15 years,,nka,"['Hypoaesthesia', 'Limb discomfort', 'Magnetic resonance imaging brain', 'Muscular weakness', 'Neck pain', 'Paraesthesia', 'Sensory disturbance']",1,PFIZER\BIONTECH,IM 936805,KY,25.0,M,Patient received the vaccine on 12/22/20 without complication. It was reported today that the patient was found unresponsive and subsequently expired at home on 1/11/21.,Yes,01/11/2021,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/11/2021,20.0,PVT,See Continuation Field,Whiplash injury to neck. Sprain of ligaments of cervical spine,"Septal defect (heart), chronic sinusitis",,Ceftriaxone,"['Death', 'Unresponsive to stimuli']",1,MODERNA,IM 936891,ND,64.0,M,Increased weakness leading to a fall and fever of 101.3,Not Reported,,Not Reported,Yes,4.0,Not Reported,,01/08/2021,01/09/2021,1.0,SEN,,,,,,"['Asthenia', 'Fall', 'Pyrexia']",1,PFIZER\BIONTECH,IM 936919,SD,32.0,F,"G3 P1 mother, estimated gestational age of baby = 4 weeks. On day 4 post-vaccine (1/11/21) started with heavy bleeding and labs confirmed miscarriage.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/11/2021,4.0,PVT,Prenatal vitamin,None,None,,Sulfa,"['Abortion spontaneous', 'Human chorionic gonadotropin', 'Progesterone', 'Vaginal haemorrhage']",2,PFIZER\BIONTECH,IM 936993,IA,42.0,F,"Patient began experiencing fevers, body aches, back pain, fatigue, chills the night she received the vaccine. Symptoms progressed for the following four days when she was ultimately seen in PCP office. Laboratory evaluation demonstrated atypical pneumonia and elevated WBC count. Patient was diagnosed with Acute Myeloid Leukemia via bone marrow biopsy and is receiving treatment at the hospital.",Not Reported,,Not Reported,Yes,7.0,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,"Levothyroxine, Trintellix",Strep,"Thyroid cancer, hypothyroidism, GERD",,Compazine,"['Acute myeloid leukaemia', 'Atypical pneumonia', 'Back pain', 'Biopsy bone marrow abnormal', 'Blast cells present', 'C-reactive protein', 'Chills', 'Computerised tomogram thorax abnormal', 'Fatigue', 'Fibrin D dimer', 'Full blood count', 'Metabolic function test', 'Pain', 'Pyrexia', 'Red blood cell sedimentation rate', 'SARS-CoV-2 test negative', 'White blood cell count increased', 'White blood cell morphology abnormal']",1,MODERNA,IM 937053,,20.0,F,Reported feeling faint and nauseated during observation period. Placed on cart in trendelenberg,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/12/2021,0.0,UNK,,,,,,"['Dizziness', 'Nausea']",1,MODERNA,IM 937089,MA,50.0,F,"Within 24 hrs, developed headaches, burning sensation down spine and neck. fullness in head intensified next day. balance was off, numbness and tingling throughout body. Went to ER. Diagnosed Paresthesia",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"Augmentin, Wellbutrin, Duloxetine, Klonipin",Diverticulitis 24 hrs prior,"Fibromyalgia, mild asthma, anxiety and depression, occasional Diverticulitis, occasional headache/migraines",,,"['Balance disorder', 'Burning sensation', 'Head discomfort', 'Headache', 'Hypoaesthesia', 'Magnetic resonance imaging', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 937127,AR,91.0,M,"The facility had positive cases of COVID when we were able to begin vaccinating residents. Within about a week of vaccination, patient was tested positive for COVID. He was 91 years old and his immune system did not have the time to allow the vaccine to begin working before exposure. His age was a major contributing factor to his death.",Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/28/2020,6.0,SEN,"Mirtazapine, Fentanyl Patch,",Chronic pain,Pain,,None,"['Death', 'SARS-CoV-2 test positive']",1,MODERNA,IM 937152,AR,91.0,F,"The facility had positive cases for COVID 19 when the vaccine was received and administered to patient. With her advanced age and chronic conditions, she did not have time to build immunity between the time of vaccination and her testing positive.",Yes,01/11/2021,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/24/2020,2.0,SEN,"Metoprolol, Cephalexin, Brimonidine, Donepezil, Losartan, Latanoprost, Timolol","High blood pressure, pain, eye issues","Blood pressure, pain",,None,['SARS-CoV-2 test positive'],1,MODERNA,IM 937186,AR,87.0,F,"The facility had a number of positive COVID 19 cases prior to patients vaccination. Due to her advanced age, chronic condition, and exposure, patient did not have the time to build immunity after exposure before becoming positive.",Yes,01/10/2021,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/24/2020,2.0,SEN,"Hydrocodone-Acetamenaphin, Lidocaine, Cefritriaxone, Citalopram",Chronic pain,Pain,,None,['SARS-CoV-2 test positive'],1,MODERNA,IM 937264,WA,62.0,F,"Lethargy; Fever; Joint pain / Her joint pain was in / knees and fingers; Her joint pain was in her lower back; Flu like symptoms; Soreness at the injection site; Tiredness; Sleepiness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number GM2Y4, expiry date 10th May 2022) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis. On 17th September 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 17th September 2020, immediately after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site pain. On 18th September 2020, the patient experienced lethargy, fever, joint pain, low back pain, influenza-like symptoms, tiredness and sleepiness. On an unknown date, the outcome of the injection site pain, lethargy and fever were unknown and the outcome of the joint pain and low back pain were not recovered/not resolved and the outcome of the influenza-like symptoms, tiredness and sleepiness were recovered/resolved. It was unknown if the reporter considered the injection site pain, lethargy, fever, joint pain, low back pain, influenza-like symptoms, tiredness and sleepiness to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix and flu vaccine on same day and right away experienced soreness at injection site. The next day after vaccination experienced lethargy, fever, joint pain in lower back, knees and fingers. The patient was using heating pads for soreness and saw primary care physician.. The flu like symptoms resolved but it took 3-4 days for tiredness and sleepiness to resolve. The reporter mentioned that, patient was inquiring about the relationship between getting shingrix and the side effects. The reporter consented to follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,09/17/2020,09/17/2020,0.0,UNK,,,,,,"['Arthralgia', 'Back pain', 'Fatigue', 'Immediate post-injection reaction', 'Influenza like illness', 'Injection site pain', 'Lethargy', 'Pyrexia', 'Somnolence']",1,GLAXOSMITHKLINE BIOLOGICALS, 937266,CT,58.0,F,"fatigue; serious pain in right arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 31st December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st January 2021, 1 days after receiving Shingrix, the patient experienced pain in arm (serious criteria other: serious per reporter). On an unknown date, the patient experienced fatigue. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingrix. Additional case details were reported as follows: The patient received Shingrix in the left arm. The patient experiencing serious pain in the right arm, the day after receiving the vaccine. The pain in the right arm was a dull ache during the day and most painful at night and was ongoing. The patient also experiencing fatigue, which began a few hours after receiving the dose and resolved a few days later. The reporter consented to follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,UNK,,,,,,"['Fatigue', 'Pain in extremity']",1,GLAXOSMITHKLINE BIOLOGICALS,IM 937343,TX,37.0,F,"Within approximately 30 minutes after vaccine (Thursday), patient presented with red rash to upper chest, severe headache, dizziness and nausea. Was treated with Benadryl and Tylenol per anesthesia onsite. Symptoms remained throughout the day with minimal improvement. The following morning (Friday) only headache remained. patient began having abdominal pain, and was admitted to hospital the next day (Saturday). It is now Tuesday and patient is still hospitalized. Unclear if this entire event is vaccine related.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/07/2021,01/07/2021,0.0,OTH,unknown,unknown,unknown,,unknown,"['Abdominal pain', 'Dizziness', 'Endoscopic retrograde cholangiopancreatography', 'Headache', 'Hepatic enzyme increased', 'Nausea', 'Rash', 'Rash erythematous']",1,MODERNA,IM 937434,MT,70.0,M,Pt expired due to possible cardiac arrest. Unsure if this was vaccine related.,Yes,01/12/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/11/2021,4.0,OTH,,None known,only had 1 lung,,,['Death'],1,MODERNA,IM 937444,IL,86.0,F,Resident was found deceased at approximately 6pm in her apartment,Yes,01/11/2021,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,SEN,,"Brain bleed, sleep apnea, htn","Brain bleed, sleep apnea, htn",,,"['Death', 'Myocardial infarction']",1,PFIZER\BIONTECH,IM 937474,PR,28.0,M,"Pt experienced the following morning: fever (100 F) chills, malaise, nausea, and numbness in hands at 0624 and 0836. Pt went to hospital at 1000, tx with IV fluids.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/11/2021,01/12/2021,1.0,MIL,None,None,None,,"Dust, avocados","['Chills', 'Hypoaesthesia', 'Malaise', 'Nausea', 'Pyrexia']",1,MODERNA,IM 937480,LA,85.0,F,"In the early morning of Monday, January 11th the patient developed a significant headache with neck pain. She also reported parathesia and tingling in bilateral upper extremities with weakness of the right upper extremity. She reported feeling very anxious and ""wound up"". Patient presented to the Emergency Department 3 hours later. CT of the head/brain, EKG, CBC,CMP, Magnesium and Cardiac profile were performed with no significant findings. Ativan 0.5mg was administered orally. Patient was admitted to the facility for observation. Symptoms gradually resolved with no additional treatment.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/09/2021,01/11/2021,2.0,OTH,"Losartan,Amlodipine,Levothyroxine, Metoprolol, Crestor",None reported,"Hypertension, hypothyroidism, hyperlipidemia",,None reported,"['Anxiety', 'Blood magnesium normal', 'Cardiovascular evaluation', 'Computerised tomogram head normal', 'Full blood count normal', 'Headache', 'Metabolic function test normal', 'Muscular weakness', 'Neck pain', 'Paraesthesia']",1,MODERNA,IM 937481,NY,55.0,M,Large red area surrounding injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/10/2021,10.0,WRK,Bupropion,,,,,"['Injection site erythema', 'Injection site reaction']",1,MODERNA,IM 937527,NH,44.0,F,"unsure if related to vaccine, but was notified by her next of kin that she died on 1/4/2021. No reports of side effects or hospitalization were reported to the facility prior to the notification of death.",Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/04/2021,12.0,SEN,unknown,unknown,unknown,,unknown,['Death'],1,PFIZER\BIONTECH,IM 937569,RI,62.0,M,patient reported expired 1/7/2021,Yes,01/07/2021,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/07/2021,5.0,OTH,unknown,unknown,unknown,,unknown,['Death'],1,MODERNA,IM 937579,MN,64.0,M,"On 12/31/2020, at approximately 00:15, pt developed a fever of 102.9 F and tachycardia with rate of 120. He was treated with acetaminophen. Later in the morning, he complained of nausea, generalized muscle aches, intermittent increase in confusion. At approximately 14:00, he had a fall out of bed and at that time noted to be short of breath, tachypneic. He was taken via ambulance to Emergency Department. From there he was transferred to Hospital for admission with acute respiratory distress, suspected sepsis with lactic acid 7.4 and Bilateral Pulmonary Emboli. He was started on heparin and broad spectrum antibiotics and transitioned to ELIQUIS on 1/3/2021. Infectious etiology of sepsis was unclear. He continued broad spectrum antibiotics with clinical improvement. Abdominal CT scan was obtained due to intermittent nausea, vomiting, abdominal pain, loose stools. His heart rhythm flipped to Atrial Fibrillation with RVR on 1/2 and his rate improved with titration of metoprolol. He was also treated with prednisone for suspected underlying undiagnosed COPD. It is noted in his hospital summary that PEs presumed provoked in the setting of his recent COVID 19 infection. He was discharged from the hospital on 1/8/2021 and readmitted to the Veterans Home. He has been stable.",Not Reported,,Not Reported,Yes,8.0,Not Reported,U,12/30/2020,12/30/2020,0.0,SEN,Zyprexa 15 mg tablet once daily Levothyroxine 100 mcg tablet once daily Metformin ER 500 mg tablet 2 tablets by mouth twice daily Divalproex DR 240 mg Give 3 tablets by mouth once daily Metoprolol tartrate 50 mg tablet by mouth twice daily,"COVID 19 (tested positive on 11/27/2020). Appeared to have recovered, but had some weight loss as well as persistent weakness, activity intolerance.","Schizophrenia Dementia without behavioral disturbance Personal history of covid-19 (Tested positive on 11/27/2020) Type 2 diabetes mellitus Morbid Obesity Essential Hypertension BPH with LUTS Allergic rhinitis Hypothyroidism Seborrheic dermatitis Fatty liver disease Pancytopenia Glaucoma History of nicotine dependence, cigarettes",,Ciclopirox- erythema and pruritus Naltrexone- reaction dizziness Topiramate- mood changes,"['Abdominal pain', 'Acute respiratory distress syndrome', 'Arteriosclerosis coronary artery', 'Ascites', 'Atrial fibrillation', 'Blood culture negative', 'Blood lactic acid', 'Blood potassium decreased', 'Brain natriuretic peptide normal', 'C-reactive protein increased', 'Chronic obstructive pulmonary disease', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram thorax abnormal', 'Confusional state', 'Culture urine positive', 'Diarrhoea', 'Dyspnoea', 'Electrocardiogram abnormal', 'Fall', 'Haematocrit decreased', 'Haemoglobin decreased', 'Hepatic cirrhosis', 'Hiatus hernia', 'International normalised ratio increased', 'Lipase normal', 'Lung opacity', 'Myalgia', 'Nausea', 'Oedema', 'Pancreatitis', 'Platelet count decreased', 'Portal hypertension', 'Procalcitonin increased', 'Pulmonary embolism', 'Pyrexia', 'Red blood cell count decreased', 'Scan with contrast', 'Sepsis', 'Sinus tachycardia', 'Splenic granuloma', 'Tachycardia', 'Tachypnoea', 'Vomiting', 'White blood cell count decreased']",1,MODERNA,IM 937582,VA,38.0,F,"Received Moderna vaccine on 1/5. Had a single episode of vomiting approximately 1 hour after vaccine. Hx of Asthma, started to develop SOB approximately 2 days later. She reached out to PCP and used inhaler with little relief. SOB worsened and she was admitted to the hospital on 1/8/21. Eval was negative for COVID (3 tests completed), flu and pneumonia. She has elevated WBCs and was given steroids and supplemental oxygen. She is improving but remains inpatient.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/05/2021,01/08/2021,3.0,OTH,unknown,none,Asthma,,coconut,"['Dyspnoea', 'Influenza virus test negative', 'Laboratory test normal', 'SARS-CoV-2 test negative', 'Vomiting', 'White blood cell count increased']",1,MODERNA,IM 937739,,,F,"cellulitis in her upper chest area; pain at the injection site all the way up to her jaw; redness all over her right shoulder; pain at the injection site; This spontaneous report was received from a female patient in her 60's, referring to herself. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (formulation, exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis and subsequently experienced pain at the injection site all the way up to her jaw and redness all over her right shoulder. After a few days, she developed cellulitis in her upper chest area and had to go to urgent care for treatment. It was unknown whether any lab diagnostics/studies were performed. The outcome of the events was unknown. The relatedness between the suspect therapy and the events was not provided Upon internal review, the event of cellulitis was considered medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Cellulitis', 'Erythema', 'Injection site pain', 'Pain in jaw']",UNK,MERCK & CO. INC., 937746,,65.0,F,"Vaccination induced cytokine storm; IgA-Kappa MM; Severe-symptomatic hypercalcemia; Flu-like symptoms; This literature case was received on 04-Jan-2021, concerning a 65-year-old female patient. The patient's concurrent conditions included multiple myeloma (MM). The patient's concomitant medications were not reported. On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; anatomical location, dose, route of administration and indication: not reported). The batch number was not reported. On an unspecified date, 5 days after receiving influenza virus vaccine polyvalent, the patient presented with subjective myalgias lasting two days. Vital signs were stable, complete blood count (CBC) and basic metabolic panel (BMP) were unremarkable and serum calcium was 10.8 mg/dl. The patient was discharged on supportive therapy. On an unspecified date, the day later, the patient presented with persistent flu-like symptoms. Labs revealed serum calcium being above 22 mg/dl; normal renal function, total protein, albumin, angiotensin converting enzyme (ACE) levels; clear urine analysis (UA) with no albuminuria; low parathyroid hormone (PTH) and 1, 25-(OH)2-Vitamin D3 levels; elevated parathyroid hormone-related protein (PTHrP) and viscosity levels. 24-hour urine collection revealed proteinuria (550 mg). Peripheral blood smear revealed rouleaux formation. Computerized tomography (CT) scans of the chest, abdomen and pelvis revealed no obvious malignancy. Quantitative immunoglobulins (Ig) revealed elevated IgA (2415 mg/dl), and concurrent suppression of IgG and IgM levels. Quantitative serum light chain measurement revealed normal levels of kappa and lambda, with an elevated Kappa: Lambda ratio of 2:1. Serum protein electrophoresis (SPEP), urine protein electro-phoresis (UPEP) and serum immunofixation revealed IgA-Kappa MM. The patient developed severe-symptomatic hypercalcemia, she was treated with aggressive intravenous crystalloids, loop diuretics, calcitonin, Pamidronate (pamidronate disodium), and hemodialysis. The patient's calcium subsequently normalized to 10.1 mg/dl. Bone-marrow biopsy revealed intracytoplasmic kappa-restricted monoclonal plasma cells that occupied 40% of the marrow. Bone survey was negative for lytic lesions. The patient was started on bortezomib, lenalidomide, dexamethasone and monthly zoledronic acid, and she has not attained remission from myeloma yet. On an unknown date, the patient recovered from the event 'hypercalcemia'. At the time of initial report, the patient had not recovered from 'multiple myeloma'. The outcome of all the rest events was not reported. The reporters assessed the event of 'cytokine storm' as related to the influenza virus vaccine polyvalent. It was theorized that the inactivated influenza vaccine given prior to presentation unmasked an atypical presentation of MM. This may be attributed to a vaccination induced cytokine storm, especially IL-6 mediated that may be the key in the pathophysiology of hypercalcemia related to MM. The reporter did not provide a causality assessment for other events. The events of 'cytokine storm' and 'multiple myeloma' were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department. Company comment: A 65-year-old female patient experienced cytokine storm, plasma cell myeloma, hypercalcemia and influenza like illness. Symptoms of the reported events started emerging one day after administration of influenza virus vaccine polyvalent. Very detail laboratory and diagnostic findings were provided in the report. Causality is assessed as possibly related for influenza like illness and for cytokine storm due to biological plausibility and presented information and unrelated for plasma cell myeloma due to biological and temporal implausibility. Hypercalcemia is more likely related to myeloma however the reporter's rationale points to vaccine as well, therefore assessed as unlikely related. (''unlikely related'' defaults to ''related'' in the safety database for reporting purposes); Reporter's Comments: It was theorized that the inactivated influenza vaccine given prior to presentation unmasked an atypical presentation of MM. This may be attributed to a vaccination induced cytokine storm, especially IL-6 mediated, that may be the key in the pathophysiology of hypercalcemia related to MM.; Sender's Comments: A 65-year-old female patient experienced cytokine storm, plasma cell myeloma, hypercalcemia and influenza like illness. Symptoms of the reported events started emerging one day after administration of influenza virus vaccine polyvalent. Very detail laboratory and diagnostic findings were provided in the report. Causality is assessed as possibly related for influenza like illness and for cytokine storm due to biological plausibility and presented information and unrelated for plasma cell myeloma due to biological and temporal implausibility. Hypercalcemia is more likely related to myeloma however the reporter's rationale points to vaccine as well, therefore assessed as unlikely related. (''unlikely related'' defaults to ''related'' in the safety database for reporting purposes)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Angiotensin converting enzyme', 'Biopsy bone marrow abnormal', 'Blood 1,25-dihydroxycholecalciferol decreased', 'Blood albumin normal', 'Blood calcium increased', 'Blood immunoglobulin A increased', 'Blood immunoglobulin G decreased', 'Blood immunoglobulin M decreased', 'Blood parathyroid hormone decreased', 'Blood viscosity increased', 'Computerised tomogram abdomen', 'Computerised tomogram thorax normal', 'Cytokine storm', 'Electrophoresis protein', 'Full blood count normal', 'Haemodialysis', 'Hypercalcaemia', 'Immunology test', 'Influenza like illness', 'Light chain analysis', 'Light chain analysis abnormal', 'Light chain analysis increased', 'Metabolic function test normal', 'Myalgia', 'Parathyroid hormone-related protein increased', 'Plasma cell myeloma', 'Protein total normal', 'Protein urine present', 'Proteinuria', 'Red blood cell rouleaux formation present', 'Renal function test normal', 'Rouleaux formation', 'Urine analysis normal', 'Urine electrophoresis abnormal']",UNK,UNKNOWN MANUFACTURER,OT 937773,KS,85.0,M,Patient was sent to the ED due to significant hematuria. He was afebrile.,Yes,01/03/2021,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,SEN,,COVID-19 positive on 11/30/2020,"Parkinson's Disease, Diabetes, Heart disease, A-fib, Hypothyroidism",,"Baclofen, PCN, Ambien, Singulair",['Haematuria'],1,PFIZER\BIONTECH,IM 937932,UT,28.0,M,"Patient presented with myalgias, fevers, and chest pain on 1/10/21 and was found to have diffuse ST elevation and elevation troponin. He was evaluated by cardiology and diagnosed with acute myopericarditis. He was treated with NSAIDs and colchicine. He improved with this treatment and was discharged on 1/12/21 with ibuprofen and colchicine and outpatient cardiology follow up.",Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,,,No known chronic conditions,,Spring seasonal allergies,"['Chest pain', 'Electrocardiogram ST segment elevation', 'Myalgia', 'Myocarditis', 'Pyrexia', 'Troponin increased']",UNK,PFIZER\BIONTECH, 937944,TX,36.0,F,"began having numbness to face, tingling to hands and legs and dizziness with movement and that her legs were going to give out",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,WRK,none,none,none,,NKDA,"['Dizziness', 'Hypoaesthesia', 'Muscular weakness', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 937950,CO,33.0,F,"Rash/heat/Redness/Swelling/itching Left side of face. Emergency Room visit due to list above, Doctor believes to be shingles.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/06/2021,14.0,WRK,Skirizi,Possible Shingles (1-6-201),Psoriasis,,"Penicillin Amoxocin, Rithromiocin, Kflex, Cleocin, Ali, Sulfa, watermelon, Cantalope, Honeydews, latex","['Erythema', 'Herpes zoster', 'Pruritus', 'Rash', 'Skin warm', 'Swelling face']",UNK,UNKNOWN MANUFACTURER,SYR 937954,NV,30.0,F,Headache Nausea Fever Body aches Fatigue Swelling double the size and redness Lymph nodes swelling and achey,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Erythema', 'Fatigue', 'Headache', 'Lymph node pain', 'Lymphadenopathy', 'Nausea', 'Pain', 'Pyrexia', 'Swelling']",1,MODERNA,IM 937961,SD,33.0,F,"Pt received immunization @ 1220 she was monitored after immunization for 15min with no side effects. States she went to bed around 9:30pm, was unable to fall asleep. Developed shaking, chills, sweats and fever 101.5 @ 2am. Did take ibuprofen, some relief from shaking. Continues to have fever, bodyaches, joint pain, chills & sweating.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Omeprazole 20mg QAM,none / Covid - October,none,,none,"['Arthralgia', 'Chills', 'Hyperhidrosis', 'Initial insomnia', 'Pain', 'Pyrexia', 'Tremor']",1,MODERNA,IM 937964,PA,51.0,F,Facial /neck hives ~ 7 hours after first Moderna covid vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,,None,"OSA, Hypertension",,,['Urticaria'],1,MODERNA, 937975,MA,32.0,F,"Redness, erythema, swelling at injection site, outlined Treated with Antibiotics given delayed adverse reaction likely Cellitis",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/11/2021,7.0,WRK,prenatal,,,,,"['Injection site cellulitis', 'Injection site erythema', 'Injection site swelling', 'Skin reaction']",1,MODERNA,IM 937976,TX,,U,"-Pain in left hand, wrist to finger tip (like when you lift something heavy)",Not Reported,,Not Reported,Not Reported,,Not Reported,,,,,WRK,,,,,,"['Arthralgia', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 937979,NE,47.0,F,"Patient had a headache the next morning 1/8/20 after reving the 2nd dose on 1/2/21. On 1/7/21, later in the morning, she began to have axilla pain that radiated to her chest on the site she rcvd. the vaccine. On 1/9/21 she had symptoms of weakness, cough & a great deal of fatigue. By Sunday, 1/10/21 she was feeling fine. Patient also had shortness of breath on 1/8 that resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/08/2021,6.0,PVT,0,0,0,,NKDA / NKA,"['Asthenia', 'Axillary pain', 'Chest pain', 'Cough', 'Dyspnoea', 'Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 938049,IL,34.0,F,"Rash on neck; gall bladder attack; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration at the left arm on 18Dec2020 10:30 at a single dose for COVID-19 immunization in the hospital, and morphine sulfate (manufacturer unknown), via an unspecified route of administration from an unspecified date at unspecified dose and frequency for an unspecified indication. Medical history included S/P rouxen-y gastric bypass, sleep apnea, cholelithiasis, HSV-2, obesity, and Hashimoto hypothyroid disease. The patient was not pregnant at the time of vaccination. Concomitant medications included ursodiol, valacyclovir, levothyroxine sodium (LEVOTH) and vitamins. The patient previously took morphine and experienced allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced Rash on neck, morphine reaction and May or may not be related - gall bladder attack on 18Dec2020 14:30. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was administered with NS bolus, diphenhydramine (BENADRYL) and also morphine in response to the events. Since the vaccination, the patient had been tested for COVID-19 via Nasal Swab/COVID-19 rapid ABBT which was negative on 18Dec2020. The action taken in response to the events for morphine sulfate was unknown. The outcome of the events was recovered with sequel. The patient assessed the events as non-serious. Pfizer is a marketing authorization holder of morphine sulfate in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of morphine sulfate has submitted the same report to the regulatory authorities.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,URSODIOL; VALACYCLOVIR [VALACICLOVIR]; LEVOTH,,Medical History/Concurrent Conditions: Cholelithiasis; Gastric bypass; Hashimoto's disease; HSV infection; Obesity; Sleep apnea,,,"['Gallbladder disorder', 'Rash', 'SARS-CoV-2 test negative']",UNK,UNKNOWN MANUFACTURER, 938050,PA,76.0,M,"mild elevation of his sed rate and leukocytosis; mild elevation of his sed rate and leukocytosis; myalgia (was reported as worsened); Arthralgia; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; This is a spontaneous report from a contactable physician (patient). A 76-years-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 23Dec2020 at single dose on deltoid Right for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus (diagnosed about 8 years ago). There were no concomitant medications. Patient developed myalgia on 27Dec2020 and arthralgia on 28Dec2020. Patient also experience ten days later and still having pain/ started in neck and migrated to his back, the buttocks and gluteal and quadriceps area in Dec2020. He had labs a few days ago. He had a mild elevation of his sed rate and leukocytosis. Events myalgia and arthralgia considered serious due to medically significant. Outcome of events myalgia (was reported as worsened) and arthralgia was not recovered. Information about batch/lot number has been requested.; Sender's Comments: Based on the time association, the events myalgia and arthralgia are possibly related to suspect bnt162b2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/01/2020,,PVT,,Type 2 diabetes mellitus (Diagnosed about 8 years ago),,,,"['Arthralgia', 'Back pain', 'Leukocytosis', 'Musculoskeletal pain', 'Myalgia', 'Neck pain', 'Pain in extremity', 'Red blood cell sedimentation rate increased', 'White blood cell count increased']",UNK,PFIZER\BIONTECH, 938051,IL,37.0,F,"blood pressure increased and her pulse; blood pressure increased and her pulse; Chest pain; Numb fingers and later numb face; Mind fog; This is a spontaneous report from a contactable other HCP. This 37-year-old female other HCP (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 1685), via intramuscular at left arm on 02Jan2021 08:15 AM at single dose for COVID-19 immunization. Facility type of vaccine was pharmacy or drug store. Medical history included panic disorder (last attack 2 years prior) and known allergies: latex, Iodine dye. Concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 02Jan2021 08:15 AM, within a few minutes while still under observation at pharmacy, her blood pressure increased and her pulse. Numb fingers and later numb face. Chest pain presented. She went to ER (emergency room) 3hours later with ongoing symptoms that never resolved until 6 or 7 that evening while still in ER waiting room. Mind fog (02Jan2021 08:15 AM) was currently ongoing. The treatment for events included lorazepam (ADIVAN), diphenhydramine (BENADRYL), ibuprofen. Outcome of event mind fog was not recovered, and the rest of events was recovered/resolved with sequel.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PHM,,,Medical History/Concurrent Conditions: Iodine contrast media allergy; Latex allergy; Panic disorder (last attack 2 years prior),,,"['Blood pressure increased', 'Chest pain', 'Feeling abnormal', 'Heart rate increased', 'Hypoaesthesia']",1,PFIZER\BIONTECH,OT 938052,TX,43.0,F,"lost the sense of smell and taste; lost the sense of smell and taste; nasal congestion/stuffy nose; runny nose; tiredness/felt tired; eye pain; pain in the muscles; chills; sore pain in the arm; This is a spontaneous report from a contactable Other HCP (Dentist) reporting for herself. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 31Dec2020 at 10:00AM in the left arm for COVID-19 immunization. Lot number was EJ1685. Medical history and concomitant medications were none. On 01Jan2021 in the morning, she had a sore pain in her arm, and by nighttime she had chills. On 02Jan2021 and on 03Jan2021, Saturday and Sunday she had pain in her muscles, felt tired, and had some pain around her eye every time she moved her eyes. On 04Jan2021, Monday everything went away but she had stuffy nose and runny nose. Her stuffy and runny nose was better but she still had some congestion, but she could not blow anything out of her nose. On 05Jan2021, Tuesday she noticed she could not smell and she still could not smell. On 06Jan2021, she had no smell and no taste either. Stated everything was good at the time of report but she still could not smell or taste anything. She treated herself with Tylenol for the muscle aches. She took one 500mg Tylenol by mouth on 02Jan2021 at bedtime and then one Tylenol 500mg by mouth again on 03Jan2021. She was scheduled for the next dose 19Jan2021. Mention she was planning to get a COVID 19 test to see if she had the disease. The patient recovered from fatigue, eye pain, pain in muscles on 03Jan2021, the patient recovered from chills on 02Jan2021, the patient recovered from sore pain in the arm on 01Jan2021, the patient was recovering from nasal congestion/stuffy nose, the patient did not recover from runny nose and loss the sense of smell and taste. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported pain in her muscles, felt tired,had some pain around her eye every time she moved her eyes, had no smell and no taste, and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Ageusia', 'Anosmia', 'Chills', 'Eye pain', 'Fatigue', 'Myalgia', 'Nasal congestion', 'Pain in extremity', 'Rhinorrhoea']",1,PFIZER\BIONTECH, 938053,,,U,"aware of 6 cases of Bell's Palsy by the companies making these vaccines; This is a spontaneous report from a contactable Other HCP. This Other HCP reported similar events for 6 patients. This is 1st of 6 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter reported since the use of modified RNA in covid vaccines,he/she had aware of 6 cases of Bell's Palsy by the companies making these vaccines since an unknown date. The event outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Bell's Palsy is not uncommon in general population. The information provided in this case is limited and does not allow a full medically meaningful assessment. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021009409 Different patient, same drug/event.;US-PFIZER INC-2021009412 Different patient, same drug/event.;US-PFIZER INC-2021009410 Different patient, same drug/event.;US-PFIZER INC-2021009411 Different patient, same drug/event.;US-PFIZER INC-2021009408 Different patient, same drug/event.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Facial paralysis'],UNK,PFIZER\BIONTECH, 938054,NC,42.0,F,"joint pain and muscle; joint pain and muscle; Vertigo; an itchy rash bilaterally on her arms; developing swollen, tender, and hard lymph nodes under the Left subclavian area/ swollen left subclavian lymph nodes; developing swollen, tender, and hard lymph nodes under the Left subclavian area; extreme fatigue; Runny nose; Headache; This is a spontaneous report from a contactable nurse (RN) reporting for herself. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 23Dec2020 h 09:00 intramuscularly in left deltoid (left arm) lot number: EK5730 at single dose for COVID-19 immunization. Concomitant medications were not provided. Patient stated that she has had double mastectomy, and missing a lot of lymph nodes, states she got the first dose of Pfizer Covid vaccine on 23Dec2020, states it made her left subclavian lymph nodes swollen and hard. States that when she gets the flu vaccine at her hospital every year, she gets swollen lymph nodes ever since she had a double mastectomy and chemotherapy. She originally was wondering if she could get the vaccine in another large muscle group. States she even went as far as to cross reference flu shot ingredients with the Pfizer Covid ingredients to see if something in the vaccines were causing the swollen lymph nodes but was unable to come to any conclusion, the only think in common is the Sodium Chloride and she does not feel like that would cause any issue. States the swollen lymph nodes occurred after the Sanofi brand flu vaccine (no other information known or provided). Patient is on day 15 post vaccination and they are still swollen and hard, she is wondering if there is any data on how long this side effect can last. She made an appointment with her oncologist, she knows that the swollen lymph had the first dose, lymph nodes are still swollen and hard, knows it can cause swollen lymph nodes but wants to know what is the typically length of the event. Patient also experienced other side effects, on 30Dec2020 (last week), she developed vertigo that lasted through the weekend intermittently, states she at first thought she was having a stroke. States it seems to have subsided as of 05Jan2021 (yesterday). Patient also reported she had an itchy rash twice as part of her side effects reported from the COVID 19 vaccine. She noticed an itchy rash and it went away but she is unsure exactly the day or time. Stated she definitely remembered the rash on 28Dec2020 as she took pictures. It was gone in about three hours on the same day. She did not treat the rash because it was gone and not itching. The rash came and went and had not come back. It was mostly on the bends of the arms, bilateral arms. Patient reported developing swollen, tender, and hard lymph nodes under the Left subclavian area the day after the injection, on 24Dec2020. They were not as tender at the time of the report but were continuing and this was 15 days from her vaccination. Patient also experienced an itchy rash bilaterally on her arms that occurred twice and only lasted a few hours each time, onset date reported as 25Dec2020. She was advised to take diphenhydramine hydrochloride (BENADRYL) for it however she did not take it. On 23Dec2020 patient experienced headache. On 24Dec2020 patient experienced extreme fatigue, swollen left subclavian lymph nodes and runny nose. On 30Dec2020 patient experienced joint pain and muscle and vertigo. The events headache, experienced extreme fatigue, swollen left subclavian lymph nodes, runny nose, joint pain and muscle and an itchy rash bilaterally on her arms were considered serious as medically significant events. Patient had not recovered from swollen left subclavian lymph nodes, joint pain and muscle, extreme fatigue and swollen, tender, and hard lymph nodes under the Left subclavian area, she was recovering from headache, runny nose and vertigo and recovered completely from an itchy rash bilaterally on her arms on 28Dec2020.; Sender's Comments: The Causality between the events, headache, experienced extreme fatigue, swollen left subclavian lymph nodes, runny nose, joint pain and muscle and an itchy rash bilaterally on her arms, and the administration of the COVID 19 vaccine cannot be denied based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Chemotherapy; Mastectomy (and missing a lot of lymph nodes),,,"['Arthralgia', 'Fatigue', 'Headache', 'Induration', 'Lymph node pain', 'Lymphadenopathy', 'Myalgia', 'Rash', 'Rash pruritic', 'Rhinorrhoea', 'Vertigo']",UNK,PFIZER\BIONTECH,OT 938055,,,F,"Seizure; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on an unspecified date, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient had a seizure. Clinical outcome of the adverse event was unknown at time of this report. The information on the lot number has been requested.; Sender's Comments: A possible causal relationship between seizure and BNT162B2 cannot be completely ruled out considering the temporal relationship. However, more information would allow for a full medically meaningful assessment, especially medical history, concomitant medications, concurrent illness and event details description including time lag between the onset of the event and vaccination date of BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Seizure'],UNK,PFIZER\BIONTECH, 938056,KS,64.0,F,"Her INR was 5.8 (normal range 1 to 2)/increasing INR; Scratched arm; Scratched arm and bled through 3 shirts, it kept bleeding; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EC1284), via an unspecified route of administration administered to left arm/deltoid on 29Dec2020 13:15 at single dose for COVID-19 immunization at a research medical facility; and received warfarin sodium (COUMADIN, strength 2 mg), oral (by mouth) from an unspecified date in 2017 and ongoing at ""3 1/2 tablets once daily in the evening at 5:30pm (total 7mg)"" for metal heart valve. The patient's medical history included had the surgery (for her metal heart valve), about 01Mar in 2017 (about 4 years ago) and so she thought she had been on Coumadin for about 4 years, had been on the 7mg dose for over a year; and has a history of metal heart valve and takes Coumadin for the metal heart valve. Denied illness. Denied family medical history relevant to event. There were no concomitant medications. The patient previously received Shingrix vaccine in past and remenbered she had the usual side effects from it, had mild symptoms. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not receive any other vaccines the same date of the Pfizer Suspect or 4 weeks prior. On Jan2021, the patient experienced scratched arm and bled through 3 shirts, it kept bleeding. On 04Jan2021, her international normalised ratio (INR) was 5.8 (normal range 1 to 2). The events did not lead to emergency room visit, however led to physician office visit. The events were reported as serious medically significant. The nurse got the first Pfizer COVID-19 shot on 29Dec2020 because she is a healthcare provider. She wanted information on increasing INR. The nurse has a history of metal heart valve and takes Coumadin. Her INR was typically 1.7 to 2.3. She reported her last INR, before the covid-19 vaccine was given, was ""some time ago"" but it had not varied much over the years. Normally she got her INR run and it was about 2. She had to be scheduled for her INR on the 04Jan2021 and it was 5.8 (normal range 1 to 2) and they asked about anything that may have changed and the only thing was that she got her first shot. The nurse reported not having any changes in her medications, food, or life style to account for the change, other than receiving the COVID-19 vaccine. The patient stated that it could be a serious problem if she had an accident or fell and started bleeding. A normal person's lab result is between 1 and 2, but they like to keep people with the metal heart valves between 2 and 3. She had been bleeding. She had barely scratched her arm the other day and went through 3 shirts because she kept bleeding. This is more than unusual for her, it's kind of unusual. Getting the vaccine is the only variant she has had since getting her last INR. The patient underwent lab tests and procedures which included INR (normal range 1 to 2): typically 1.7 to 2.3 on an unspecified date; it's about 2 on an unspecified date: and 5.8 on 04Jan2021. The action taken in response to the events for warfarin sodium was dose not changed. The outcome of the event INR was 5.8 was not recovered, for the other events was unknown. The nurse (patient) assessed the event ""INR was 5.8; it's normally about 2"" as related to the COVID-19 vaccine.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of International normalised ratio increased and wound hemorrhage due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,UNK,,,Medical History/Concurrent Conditions: Heart valve disorders (Coumadin for a metal heart valve); Heart valve operation (had the surgery (for her metal heart valve) on Coumadin for about 4 years),,,"['Haemorrhage', 'International normalised ratio increased', 'Scratch']",UNK,UNKNOWN MANUFACTURER,OT 938057,NY,37.0,F,"Dizziness; palpitations; resting tachycardia that persisted for 3 days; muscles aches; Chills; Restlessness; feeling unwell; arm pain; This is a spontaneous report from a contactable physician reported for herself. This 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) via intramuscular on 23Dec2020 09:30 AM on left arm at single dose for COVID-19 immunisation. Medical history included chronic kidney disease, HTN (hypertension), persistent proteinuria. No known allergies. Concomitant medication included losartan. The patient did not have other vaccine in four weeks and did not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 24Dec2020, the patient experienced dizziness, palpitations, resting tachycardia that persisted for 3 days, muscles aches, chills, restlessness, feeling unwell and arm pain, and resulted in Emergency room/department or urgent care. Treatment included paracetamol (TYLENOL). The patient had COVID tested on 28Dec2020 post vaccination, covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test result=Negative. Outcome of events was recovered.; Sender's Comments: The reported events dizziness, palpitations, resting tachycardia that persisted for 3 days, muscles aches, chills, restlessness, feeling unwell and arm pain, were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Chronic kidney disease; Hypertension; Proteinuria,,,"['Chills', 'Dizziness', 'Malaise', 'Myalgia', 'Pain in extremity', 'Palpitations', 'Restlessness', 'SARS-CoV-2 test negative', 'Tachycardia']",1,PFIZER\BIONTECH,OT 938058,FL,,F,"Hellucinogenic visions of monsters and violent events; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 05Jan2021 at 14:30 on Right arm at single dose for COVID-19 immunization in hospital. The patient medical history included Hypertension, Hypothyroid. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (LEVOXYL); Olmesartan; aluminium hydroxide gel, dried, magnesium carbonate (PEPCID); bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC); ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM MULTIGUMMIES). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took and had known allergies with bacitracin zinc;neomycin sulfate;polymyxin b sulfate (NEOSPORIN) and bacitracin zinc;neomycin sulfate;polymyxin b sulfate (POLYSPORIN). The patient experienced hellucinogenic visions of monsters and violent events on 06Jan2021 at 02:00 AM. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the event. The outcome of the event was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PVT,"LEVOXYL; ; PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]; PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDO; CENTRUM MULTIGUMMIES",,Medical History/Concurrent Conditions: Hypertension; Hypothyroidism,,,"['Hallucination, visual']",1,PFIZER\BIONTECH, 938060,MO,58.0,F,"immune deficiencies; She said the joint pain felt like ""flu"" joint pain; She said she was really sweaty, so much so, that she had sweat under her eyes; thyroid problems; feels shaky inside; Numbness facial; Exhaustion; Foggy feeling in head/feeling rundown; felt exasperated; sweating like crazy and then gets chills; felt yucky/she didn't feel good at all; Joint pain; Nausea; Chills; after receiving the COVID-19 Vaccine on (Dated), she had left upper shoulder pain.; She clarified she had some injection site pain; and the injection site was a little itchy; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246), via an unspecified route of administration on 02Jan2021 14:30 at single dose in the left upper arm for COVID-19 immunization. Medical history included Pernicious anaemia from 2006 and ongoing, Hashimoto's disease ongoing, stated she was diagnosed with Hashimoto's disease in either 1994 or 1995. Psoriatic arthritis from Nov2020 and ongoing. Potassium low ongoing, reported she has had low potassium off and on for years. She said she can't remember when she didn't have low potassium. She said she normally finds out her potassium is low when she has blood work done. She stated she has had low potassium most of her adult life. IgA deficiency from Feb2019 and ongoing, Psoriasis ongoing, paralysis in her left trapezius muscle. Concomitant medication included B-12 for pernicious anemia. She said she had the typical reactions that one might get with a vaccine. She clarified she had some injection site pain and the injection site was a little itchy on 02Jan2021. She stated on the second day (03Jan2021) she had joint pain, felt yucky, had nausea, and chills. She said the next day (04Jan2021) she felt a little better, but still had chills. She said yesterday (05Jan2021) she thought she was feeling better, but by yesterday, clarified as late afternoon and evening, she crashed. She said she has a lot of autoimmune issues and immune deficiencies, saying she has pernicious anemia and Hashimoto's disease. She said yesterday evening she experienced extreme body temperature issues. She said she was really sweaty, so much so, that she had sweat under her eyes. She said she would get really hot and had chills. She said she was feeling really bad and was feeling shaky inside. She said she thought it was important that she report what she was experiencing to Pfizer. She stated she has psoriatic arthritis, too. Reported after receiving the COVID-19 Vaccine on 02Jan2021, she had left upper shoulder pain. She clarified that she had a previous history of paralysis in her left trapezius muscle and had surgery in 1998 on her left shoulder. She said she had a weird feeling that went around where her scar was from the surgery on the back of her left shoulder. She said maybe the left shoulder pain had to do with how she held her left shoulder. She said on Monday, 04Jan2021, she had a little bit of pain in her left shoulder and by yesterday night, 05Jan2021, there was not much pain at all. Clarified her joint pain was in her ankles, wrists, hips, neck, back, and knees. She said the joint pain felt like ""flu"" joint pain. She stated she normally has joint pain with the other issues she has, but this joint pain felt different. She said the joint pain she experienced after taking the COVID-19 Vaccine was all over her body. She said yesterday (05Jan2021) her joint pain felt so much better, but later in the afternoon she didn't feel right. She said she has pernicious anemia, and thought maybe she needs her B-12 shot. She said yesterday (05Jan2021) she experienced a lot more symptoms. She said she had numbness in her face, felt extremely exhausted, had a foggy feeling, and felt exasperated. She said the symptoms didn't start until late in the afternoon into the evening of 05Jan2021. She said she did not feel well and went to bed at 8:45PM, which is early for her. She said she did give herself a B-12 1mcg/ml shot intramuscularly yesterday. She provided the B-12 1mcg/ml NDC Number: 7006900510, Lot Number: C0495, and Expiration Date: Aug2022. She said the name (company name) was listed on the B-12 1mcg/ml packaging. She said she gives herself a B-12 shot every 10 days. She said she still has some joint pain, but the joint pain is not like it was on 03Jan2021. She said she still has a tiny bit of heaviness in her joints with a constant throbbing pain, which is a different joint pain from her normal. Reported last night (05Jan2021) she didn't feel good at all. She said she felt horrible, and had to go to bed. She said she felt shaky inside all night, and still feels that way now. She said she was sweating like crazy, and then would get chills. She clarified she is used to being hot and cold in her normal life because of her thyroid problems, but stated what she experienced last night was beyond that. She said her hot and cold issue was bumped up several levels last night. She said she was chilled or sweating all the time last night, but did not have a temperature. She clarified her normal body temperature is 96.7, and when she checked her temperature at one point, her temperature was 98 degrees. Reported the hot and cold with sweating and chills, and nausea come and go. She said if she has nausea, it is a mild feeling of nausea. Clarified if Sunday, 03Jan2021. was a work day, she would have called out sick. She said Monday (04Jan2021) and Tuesday (05Jan2021) she did go to work. Reported she has low potassium and made herself an electrolyte cocktail. Reported if her system feels off, she said her electrolytes maybe off. She said her heart felt like it may be shaky, so she ate a banana to get potassium in her system. She said she does her little routine before she would call her doctor to get blood work done. She said she had her blood work done not too long ago. She said she wasn't feeling this way before she had the COVID-19 Vaccine, and is feeling rundown now. She said she was feeling good before she had the COVID-19 Vaccine. She said she feels like something is going on with her body now. Reported her last blood work was done on 04Dec2020 and everything was kind of normal. She clarified her thyroid was a little off, and her doctor adjusted her medication. She said her potassium was a little down. Reported she was told when she got the COVID-19 Vaccine shot she has to be a little more careful, and she might not be as protected as some people. She said she was told there have not been enough studies on the COVID-19 Vaccine. She clarified she was told that information by a person at the site where she received the COVID-19 Vaccination, saying the person was helping her with the COVID-19 Vaccination authorization form. Reported she thought she was doing OK after she received the COVID-19 Vaccine, until after last night and yesterday afternoon. She said if she continues feeling the way she is, she will see her doctor. She said her system seems off. She said she normally tries everything she knows first, like drinking a lot of water, and drinking electrolytes, and will take potassium to see if that is the issue. She said those are her own things that she does before she calls her doctor. Clarified sometimes she has numbness in her face due to not having her B-12. She said she still has a little numbness in face. She said on 05Jan2021, the numbness went across her face from the bridge of her nose down through to her mouth. She said the numbness was nothing like paralysis in her face, but her face was really hot at the same time she had the numbness. Reported she took Tylenol (clarified as (company) brand Tylenol, stating she doesn't have the UPC, Lot and Expiration Date). She said the Tylenol wasn't kicking in, so she took Ibuprofen (clarified as (company)brand Ibuprofen, and she doesn't have the Ibuprofen NDC, Lot and Expiration date). She said she took her normal medications. Outcome of events ""She clarified she had some injection site pain"" ""and the injection site was a little itchy"" and Shoulder pain were recovered on an unspecified date, ""Chills"" and ""feels shaky inside"" were not recovered, ""Joint pain"" ""Nausea"" ""Numbness facial"" were recovering, while outcome of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PVT,B-12,"Hashimoto's disease (Stated she was diagnosed with Hashimoto's disease in either 1994 or 1995); IgA deficiency (she has IgA deficiency - selective, according to her patient chart. No further details provided.); Pernicious anemia (Verbatim: Pernicious anemia); Potassium low; Psoriasis (Reported she has had psoriasis forever, saying since she was a kid. No further details provided.); Psoriatic arthritis (Reported she has had psoriasis for a long time, but was just diagnosed with psoriatic arthritis.)",Medical History/Concurrent Conditions: Paralysis (paralysis in her left trapezius muscle and had surgery in 1998 on her left shoulder.),,,"['Arthralgia', 'Body temperature abnormal', 'Chills', 'Discomfort', 'Fatigue', 'Feeling abnormal', 'Feeling hot', 'Feeling of body temperature change', 'Hyperhidrosis', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Injection site pain', 'Injection site pruritus', 'Irritability', 'Malaise', 'Nausea', 'Nervousness', 'Pain']",1,PFIZER\BIONTECH, 938061,,,U,"Bell's Palsy; This is spontaneous report from a contactable Other Health Professional. This reporter reported similar events for 6 patients. This is a 6th of 6 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced bell's palsy on an unspecified date with outcome of unknown. Since the use of modified RNA in COVID vaccines, the reporter aware of 6 cases of Bell's Palsy by the companies making these vaccines. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021007605 Different patient, same drug/event.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Facial paralysis'],UNK,PFIZER\BIONTECH, 938062,LA,39.0,F,"The numbness began to intensify and I could not feel myself blinking or smiling on the left side of my face; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; This is a spontaneous report from a contactable nurse reported for herself. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142) via an unspecified route of administration on 07Jan2021 07:00 at single dose for covid-19 immunization. Vaccine location was left deltoid. The facility type vaccine was Workplace Clinic. Medical history included food allergy at shrimp. Concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 07:15 AM the patient notice pain and numbness to her left ear and left jaw that began to spread down left jaw and upward across left cheek, left eye, and left temple, and above left eyebrow. The numbness began to intensify and patient could not feel herself blinking or smiling on the left side of my face. The numbness slowly began improving over the next hour in the same order that it began, but she still have mild left ear and jaw pain and mild numbness. Events outcome are recovering. No treatment was received. The action taken was not applicable.; Sender's Comments: Based on the compatible time association, the facial palsy is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Fish allergy,,,"['Ear pain', 'Eye pain', 'Facial pain', 'Hypoaesthesia', 'Hypoaesthesia eye', 'Pain in jaw']",1,PFIZER\BIONTECH, 938063,AZ,45.0,M,"Burst blood vessel in left eye 24 hours after vaccine was given.; This is a spontaneous report from a contactable other-HCP. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number not available, via an unspecified route of administration on 21Dec2020 07:45 AM at single dose for covid-19 immunization. Vaccine location was left deltoid. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included morbid obesity and blood pressure high. No known allergies. Patient didn't do relevant test. Concomitant medication included amlodipine (AMLODIPINE) at 5mg daily. The patient experienced burst blood vessel in left eye 24 hours after vaccine was given (eye haemorrhage) on 22Dec2020 08:30 with outcome of recovered. No treatment received. The action taken in response to the event for BNT162B2 was not applicable. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, the company considers that a causal relationship between the eye haemorrhage and vaccination with BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PUB,,,Medical History/Concurrent Conditions: Blood pressure high; Morbid obesity,,,['Eye haemorrhage'],1,PFIZER\BIONTECH, 938064,MT,54.0,M,"Had ruptured blood vessels x 2 spontaneously in eyes; This is a spontaneous report from a contactable nurse reported for herself. A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), via an unspecified route of administration on 17Dec2020 03:00 P.M at single dose for covid-19 immunization. The facility type vaccine was: workplace clinic. Medical history included manifesting carrier BMD (Becker's muscular dystrophy). Allergies to medication: allergies rash on Sulfa. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included pregabalin (LYRICA), duloxetine hydrochloride (DULOXETINE [DULOXETINE HYDROCHLORIDE]). The patient experienced ruptured blood vessels x 2 spontaneously in eyes (eye haemorrhage) on 18Dec2020 with outcome of recovered. No treatment received. The action taken in response to the event for BNT162B2 was not applicable.; Sender's Comments: Based on the available information, the company considers that a causal relationship between the eye haemorrhage and vaccination with BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,WRK,LYRICA; DULOXETINE [DULOXETINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Becker's muscular dystrophy,,,['Eye haemorrhage'],UNK,PFIZER\BIONTECH, 938065,LA,62.0,F,"some congestion that just came on; her arm was really aching after the injection; she started coughing; voice was hoarse; light wheeze; soles of her feet were hurting; pressure in bilateral groin; aching all over; very tired; balance issues; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231) intramuscularly in left upper arm on 05Jan2021 at single dose for covid-19 immunisation. The patient got her Covid vaccine yesterday (05Jan2021) around 11 or 11:30 am in her left upper arm. She had bilateral breast cancer and had lymph nodes removed in each arm but more removed from her Right, so she got the vaccine in the left arm. She also had some skin cancers removed, one would not heal properly on her left arm and formed a blister, and her dermatologist popped it and put a band aid on it. The vaccine was given 3 inches above it. The patient's concomitant medications were not reported. The patient experienced pressure in bilateral groin, aching all over, very tired and balance issues on 05Jan2021; light wheeze on 06Jan2021. Seriousness for these events was medically significant. The patient stated she had some congestion that just came on. She felt fine yesterday (05Jan2021) right after getting the vaccine, that at work she did notice that there was something different feeling in the left side of her groin. She was not in direct patient care. She noticed on her left side in the groin, something felt different, then yesterday evening (05Jan2021) after work she was really tired in the evening, aching all over last night, even the soles of her feet were hurting, woke up like her balance was off, she would walk one way and go another, states it is not like an orthostatic issue, that she knows what that feels like. She stated that in her inguinal area she could feel pressure, bilaterally. Her arm was really aching after the injection. Her breathing, heard a light wheezing, was clearing her voice, and then she started coughing, voice was hoarse. The outcome of events pressure in bilateral groin, very tired and light wheeze was not recovered; of events aching all over and balance issues was recovering; of other events was unknown.; Sender's Comments: The reported events bilateral groin, aching all over, very tired, balance issues and light wheeze were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Blister; Breast cancer female (she had bilateral breast cancer and had lymph nodes removed in each arm but more removed from her Right); Lymph node excision (she had bilateral breast cancer and had lymph nodes removed in each arm but more removed from her Right); Skin cancer excision (some skin cancers removed),,,"['Balance disorder', 'Cough', 'Discomfort', 'Dysphonia', 'Fatigue', 'Musculoskeletal discomfort', 'Pain', 'Pain in extremity', 'Respiratory tract congestion', 'Throat clearing', 'Wheezing']",1,PFIZER\BIONTECH,OT 938066,MD,51.0,F,"Severe respiratory distress; This is a spontaneous report from a contactable pharmacist. A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection),Lot# lot number: EL1284, intramuscular at right arm on 07Jan2021 12:00 PM, at SINGLE DOSE for COVID-19 immunization. No known allergy , no other medical history.No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was Nursing Home/Senior Living Facility .No any other vaccines within 4 weeks prior to the COVID vaccine. No Concomitant medications (received within 2 weeks of vaccination) . On 07Jan2021 the patient experienced Severe respiratory distress that resulted in Emergency room/department or urgent care.It was unknown if treatment was received for the event. The patient had not been tested for COVID post vaccination. The outcome of the event was unknown.; Sender's Comments: A possible causal relationship between Severe respiratory distress and BNT162B2 cannot be completely ruled out considering the temporal relationship. However, more information would allow for a full medically meaningful assessment, especially medical history, concomitant medications, concurrent illness and event details. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Respiratory distress'],1,PFIZER\BIONTECH,OT 938067,FL,95.0,F,"she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; This is a spontaneous report from a contactable nurse. A 95-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), Lot# EH9899 Exipration on 06Jan2021 at 15:00 at SINGLE DOSE at deltoid for COVID-19 immunization. The patient received first dose of the same vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), Lot# EH9899 Exipration date : 31Mar20221, on 16Dec2020. Medical history included : cardiac failure congestive, hypertension, cardiac murmur .There were no concomitant medications. The patient previously took cymbalta , vasotec and zocor and experienced drug hypersensitivity. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.This nurse,worker at a skilled nursing facility, reported that this patient with a history of heart failure, received her second dose of the Pfizer-BioNTech Covid-19 vaccine yesterday, 06Jan2021, at 3pm. At 7am on 07Jan2021 she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive. Patient was stable prior to vaccination, but will now be transferred to hospice care. The nurse added the patient had the second COVID vaccine on 06Jan2021 yesterday and has now been transport to hospital due to a drastic decline after the shot. It was explained that this morning around 7 am she was transferred to the hospital. She was experiencing tachycardia, shortness of breath, and congestion. The events started this morning around 6-6:30am. The patient was admitted to the hospital. The shot was given at the facility. She received it at 3pm on 06Jan2021, First dose was on 16Dec2020.The caller relays she didn't know how aggressive the hospital will be for the patient. She was a full code when left and now a DNR and is unresponsive. The patient will be going on hospice care. The causality was reported as related. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tachycardia, shortness of breath, congestion, unresponsive, and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The patient's pre-existing medical condition of cardiac failure congestive, hypertension, cardiac murmur are confounding factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/06/2021,01/07/2021,1.0,OTH,,,Medical History/Concurrent Conditions: Cardiac murmur (Verbatim: Cardiac murmur); Congestive heart failure (Verbatim: Congestive heart failure); Hypertension (Verbatim: Hypertension),,,"['Cardio-respiratory arrest', 'Dyspnoea', 'Respiratory tract congestion', 'Tachycardia', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH, 938068,CA,46.0,M,"patient developed acute onset of right-sided facial palsy and pain; patient developed acute onset of right-sided facial palsy and pain; Brain MRI done showing T2 hyperintensity in the brainstem and basal ganglia, suspicious for inflammation; This is a spontaneous report from a contactable physician. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 18Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included psoriasis. No COVID prior vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine.No known allergies. Concomitant medications (received within 2 weeks of vaccination) included fluoxetine. days following vaccination,on 23Dec2020,the patient developed acute onset of right-sided facial palsy and pain. Brain MRI done showing T2 hyperintensity in the brainstem and basal ganglia, suspicious for inflammation. Work-up is ongoing. AE Resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage].It was unknown if the event was treated. The event was assessed as serious for Disabling/Incapacitating. The patient had been tested for COVID post vaccination (covid test result-Negative). The outcome of the events werenot recovered Information about lot/batch number has been requested.; Sender's Comments: A possible causal relationship between acute onset of right-sided facial palsy and pain with MRI findings suspicious for brain inflammation and BNT162B2 cannot be completely ruled out considering the temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/18/2020,12/23/2020,5.0,UNK,,,Medical History/Concurrent Conditions: Psoriasis,,,"['Facial pain', 'Facial paralysis', 'Magnetic resonance imaging brain abnormal', 'Noninfective encephalitis', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH, 938069,NY,43.0,M,"myositis; This is a spontaneous report from a contactable physician. A 43-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date in Dec2020 reported as around the end of December, at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date after he received the vaccine he had right arm pain and swelling (states it was in his bicep brachial radialis in the muscle) which is the opposite arm of the injection site. He had an MRI done on an unknown date that showed myositis. He thinks could be due to the vaccine since it started two days after he received the vaccine. His pain peaked at about a week and a half and now the pain was improving and the swelling was down. He still had function in the right arm but when he strained it would hurt. His concern was that the reaction may be an autoimmune reaction and the first response was muted. He was worried the second dose may elicit a larger response. At the time of the reporting the patient was recovering from the events. Information on Lot/Batch number has been requested.; Sender's Comments: Based on the available information, the company considers that a causal relationship between the myositis and vaccination with BNT162B2 cannot be excluded. Additional information regarding onset latency, relevant medical history, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,,,PVT,,,,,,"['Anxiety', 'Magnetic resonance imaging abnormal', 'Muscle swelling', 'Myalgia', 'Myositis', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH,OT 938071,IL,62.0,F,"Atrial fibrillation; Was not feeling well; Warm sensation in chest; This is a spontaneous report from a contactable nurse (patient). This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EJ 1685), intramuscular, on 21Dec2020 at 09:30 PM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 62-years-old. The patient received also varicella zoster vaccine RGE (CHO) (SHINGRIX) on 19Nov2020. Medical history included gastrooesophageal reflux disease (GERD) and high cholesterol. Concomitant medications included omeprazole, colestyramine (QUESTRAN), and vitamins. On 22Dec2020, the patient was not feeling well intermittently starting the day after the injection with warm sensation in chest that would go away until 31Dec2020 when the warm sensation of chest would not go away. The patient was sent for EKG that showed atrial fibrillation that she is now being treated for. The events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. Outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported atrial fibrillation and the administration of COVID 19 vaccine, BNT162B2. More information regarding the clinical course, the patient's underlying concurrent medical condition are required for the Company to make a more meaningful causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, Agency, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/22/2020,1.0,PVT,; QUESTRAN;,,Medical History/Concurrent Conditions: GERD; High cholesterol,,,"['Atrial fibrillation', 'Chest discomfort', 'Electrocardiogram abnormal', 'Malaise']",UNK,PFIZER\BIONTECH,OT 938072,,,F,"blood in the stool; fevers; night sweats; chills; aches; This is a spontaneous report from a contactable Physician reporting for herself. A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She experienced chills and aches after 24 hours (on 31Dec2020) and experienced significant fevers that wouldn't break and cycles of chills and fevers that would last for 2 hours each cycle over the next 24 hours. She also experienced night sweats and blood in the stool and mentioned it was the first time that happened to a healthy 30 year old like her. She is asking for reports of these side effects, especially blood in the stool and for recommendations regarding taking the 2nd dose as she is still not sure on whether to take it due to hearing that the 2nd dose side effects were worse. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of blood in the stool. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,UNK,,,,,,"['Chills', 'Haematochezia', 'Night sweats', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 938074,AL,78.0,M,"Tested positive for COVID-19; CT showed increased infiltrates 10-15%; Dehydration/Dehydrated; Chills; Tested positive for COVID-19; Hypotensive; Achy; Severe achy cramps/Severe cramps all over body; This is a spontaneous report from a contactable nephrologist (patient himself). This 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via an unknown route, on 17Dec2020 at single dose for COVID-19 immunisation. Age at vaccination was 78-year-old. The patient was diabetic and hypertensive. Additional medical history included hyperlipidaemia. No relevant concomitant medications were provided. On 18Dec2020, the patient developed severe achy cramps/severe cramps all over body. On 19Dec2020, the patient developed achy. On 20Dec2020, the patient was dehydrated and hypotensive, he had also chills. On unknown date, blood pressure was down to 76/50. His symptoms for COVID were severe achy cramps, hypotension, and dehydration. On 20Dec2020, COVID-19 test was positive. On 21Dec2020, the patient was given monoclonal antibodies. A computerized tomogram (CT) of the lungs was performed on 21Dec2020 and it was ok. A week later (Dec2020), he had a repeat CT which showed increased infiltrates of 10 to 15%. He then started on dexamethasone, apixaban (ELIQUIS) and the rest of the things. He had a repeat CT on 05Jan2021 which showed resolution of the infiltrates; most of the lesions went gone. CT results had improved significantly. The patient underwent a second COVID test a week ago which was still positive. He had a third COVID on 06Jan2021, but results were not available yet. The patient queried if he can proceed with second dose planned on 07Jan2021 or if he should wait. The clinical outcome was recovered for the event 'severe achy cramps/severe cramps all over body' on 19Dec2020, for 'dehydration/dehydrated' on 20Dec2020, for 'chills' on unknown date in Dec2020, for 'achy' on 30Dec2020, for 'hypotensive' on 20Dec2020; the outcome of the event 'CT showed increased infiltrates 10-15%' was recovering; the outcome for 'Tested positive for COVID-19' was unknown. The reporter considered the events 'achy' and 'severe achy cramps/severe cramps all over body' serious because causing disability; the events 'tested positive for COVID-19', 'dehydration/dehydrated', 'chills' and 'hypotensive' were considered medically significant. The reporter considered the events 'Tested positive for COVID-19', 'CT showed increased infiltrates 10-15%' and 'dehydrated/dehydration' unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. Case will be reassessed when new information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/17/2020,12/18/2020,1.0,UNK,,,Medical History/Concurrent Conditions: Diabetic; Hyperlipidaemia; Hypertensive,,,"['Blood pressure decreased', 'Chills', 'Computerised tomogram thorax abnormal', 'Dehydration', 'Hypotension', 'Lung infiltration', 'Muscle spasms', 'Pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 938075,PA,94.0,F,"Possible cellulitis; slight redness in left upper within 24 hours; severe redness and swelling and warmth of entire upper left arm and half of lower arm; severe redness and swelling and warmth of entire upper left arm and half of lower arm; Some pain; This is a spontaneous report from a contactable Physician. A 94-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140) on 30Dec2020 at 12.00 pm at single dose Intramuscular on left arm for COVID-19 immunization. Relevant medical history included COVID 19 infection, on 19Jul2020, post COVID left femoral DVT oral anticoagulation, Alzheimer dementia, Osteoarthritis, Spinal Stenosis, Gait Dysfunction and Constipation. Known allergies included acetazolamide, penicillin and sulfa. Concomitant medications included apixban (ELIQUIS ) 5 mg twice a day, colecalciferol (VIT D3) 1000u once a day. On 31Dec2020 at 12:00 pm patient experienced slight redness in left upper within 24 hours. The patient also experienced possible cellulitis, severe redness and swelling and warmth of entire upper left arm and half of lower arm. Some pain. No fever. It was also informed that patient underwent nasal Swab test for Coronavirus (Abbott BinaxNOW) on 05Jan2021 and on 07Jan2021 and resulted negative, for both. Treatment received for cellulitis included Cefuroxime. Outcome for the event possible cellulitis was unknown. Outcome of other reported events was recovering.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported events due to temporal association. However patient old age and other underlying conditions cannot be excluded for a contributory role The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,OTH,ELIQUIS; VIT D3,,Medical History/Concurrent Conditions: Constipation; COVID-19; Dementia Alzheimer's type; DVT; Gait disorder; Osteoarthritis; Penicillin allergy; Spinal stenosis; Sulfonamide allergy,,,"['Erythema', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Peripheral swelling', 'SARS-CoV-2 test negative', 'Skin warm']",1,PFIZER\BIONTECH,OT 938078,AR,70.0,F,"Facial paralysis; This is a spontaneous report from a contactable Pharmacist. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899, Expiration Date 30Mar2021), via intramuscular, on 17Dec2020 (at 15:35), at single dose of 0.3 mL for COVID-19 immunisation. The patient was vaccinated at hospital, age at vaccination was 70-year-old. Vaccine location was deltoid but unsure which deltoid. The patient did not have a relevant medical history and concomitant medications. Pharmacist said that after vaccination, she waited to be monitored the standard 15 minutes at hospital and then when she got in the car and was on the way home like 20 minutes later she had brief episode of what the patient described as facial paralysis. It was like the side of her face in one area felt funny, it felt numb and it was not anywhere else on her face. It lasted the 20 minutes and then went away. The patient had recovered from the events on 17Dec2020. The pharmacist queried if the patient can proceed with the 2nd dose of the vaccine. The reporting pharmacist considered the event 'facial paralysis' as non-serious.; Sender's Comments: A possible causal relationship between acute onset of facial paralysis and BNT162B2 cannot be completely ruled out considering the temporal relationship and the known adverse event profile of the suspect vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Facial paralysis', 'Hypoaesthesia']",1,PFIZER\BIONTECH,OT 938080,CA,51.0,M,"got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; Left arm was extremely painful; This is a spontaneous report from a contactable Other-HCP. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EL1284) on 02Jan2021 at 10:00 AM at single dose via intramuscular on left arm for COVID-19 immunization. Medical history included allergy to codeine hypertension and asymptomatic HIV infection. Concomitant medications were not reported. Patient got home from the shot on 02Jan2021 at 11: 45 am. Fell asleep until 930p:m. During sleep was told by family that He was angry, cursing and yelling in his sleep. He didn't remember any of it, He felt delirious and out of control. Left arm was extremely painful. At the time of the reporting had recovered from the events without any treatment.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event delirious cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Asymptomatic HIV infection; Hypertension,,,"['Delirium', 'Feeling abnormal', 'Pain in extremity', 'Sleep talking']",1,PFIZER\BIONTECH,OT 938081,PA,58.0,F,"lymph node swelling and lymphedema in the right forearm side and the right upper arm; lymph node swelling and lymphedema in the right forearm side and the right upper arm; cold blister on lip; significant swelling on the right side of the base of her neck near her clavicles; slightly itchy scalp; redness, swelling, tenderness at injection site; redness, swelling, tenderness at injection site; redness, swelling, tenderness at injection site; This is a spontaneous report from a contactable Registered nurse reporting for herself. A 58-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (Batch/lot number: EL0140), in Hospital, by intramuscular route in right upper arm on 23Dec2020 at 08:30, at 58-year-old of age, at single dose for COVID-19 immunization. The patient had no relevant medical history. She didn't receive any prior vaccinations within 4 weeks. There were no concomitant medications. The patient reported that it has been 2 weeks since she received the COVID-19 Vaccine now and she still has a considerable amount of lymph node swelling and lymphedema in the right forearm side and the right upper arm. The nodes on the right side of her neck around the clavicle have been quite swollen for about 2 weeks. She has the list of side effects so she was not concerned, as this was listed but now she's not sure. When she got the vaccine she had the expected redness, swelling and tenderness at injection site (onset reported as 23Dec2020). On the evening of the 24Dec2020 she had an itchy scalp but she didn't see any rash and that only lasted a short time. On 29Dec2020 the patient had a significant swelling on the right side of the base of her neck near her clavicles that wrapped around to the posterior of her neck and was assessed as medically significant. She treated it by putting ice on it in the evening. On 30Dec2020 the swelling seemed to be slightly decreased but it is still a visible lump, the nodes are firm and there is swelling around those and it has not improved since the 30Dec2020. On 30Dec2020 she noticed a little cold blister or hive on the center of her lower lip and that was resolved by 03Jan2021, she did not have fever and did not feel sick, but her main problem is the swollen lymph nodes around base of neck around clavicle and it is considerably swollen there. The patient reported that last night (06Jan2021) it looked like her right arm was swollen, she thinks she is having lymphedema on the right arm, her right forearm is half an inch circumference larger than her left arm and was measured at her work. The patient reported she is seeing her new primary care doctor on 26Jan2021 and will follow up with the doctor. The patient wanted to know if she should get the second dose scheduled for the next week or should wait until the swelling resolves. Moreover the patient asked how long do the side effects usually last (specifically systemic side effects). The events ""redness, swelling and tenderness at injection site"" and ""slightly itchy scalp"" resolved on 25Dec2020, the event ""Cold blister on lip"" resolved on 03Jan2021. The event ""Swelling on the right side of the base of her neck near her clavicles"" had not resolved yet at the time of the report. All the reported events were assessed as related to the COVID-19 Vaccine by the Primary Source Reporter (Method of assessment:Agency).; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events swelling and lymphadenopathy cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy', 'Lymphoedema', 'Oral herpes', 'Pruritus', 'Swelling', 'Urticaria']",1,PFIZER\BIONTECH,OT 938082,TX,,F,"kidney infection; urine turning a different color/urine was an orange color/urine was a tea color; This is a spontaneous report from a contactable Nurse reporting for herself. A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated earlier this afternoon (07Jan2021) urine turning a different color, her urine was an orange color, and this afternoon her urine was a tea color. She had no other symptoms as if she had a kidney infection. The outcome of the events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the event kidney infection cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,UNK,,,,,,['Chromaturia'],1,PFIZER\BIONTECH, 938084,NY,62.0,F,"Nausea; Diarrhea; Jitteriness; foggy head or brain; she can't concentrate /she didn't pay it any attention; sleeping a lot; sick; Headache; body aches; This is a spontaneous report from a contactable nurse. A 62-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 05Jan2021 08:15 at single dose for COVID-19 immunisation. Anatomical location of administration of vaccine was right deltoid. Medical history was not reported. The patient previously took omeprazole (PRILOSEC) and experienced drug hypersensitivity and lip swelling. Concomitant medication included atorvastatin (LIPITOR). The patient experienced headache on Jan2021, body aches on Jan2021, nausea on 06Jan2021, diarrhea on Jan2021, jitteriness on Jan2021, foggy head or brain on Jan2021, sleeping a lot on Jan2021, sick on Jan2021, she can't concentrate /she didn't pay it any attention on Jan2021. The outcome of headache and she can't concentrate /she didn't pay it any attention was recovering, of pain, jitteriness, foggy head or brain was not recovered, of sleeping a lot and sick was unknown. Nausea, and diarrhea recovered on 07Jan2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events headache, pain, nausea, diarrhea, feeling jittery, feeling abnormal, disturbance in attention and hypersomnia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/01/2021,,PVT,LIPITOR [ATORVASTATIN],,,,,"['Diarrhoea', 'Disturbance in attention', 'Feeling abnormal', 'Feeling jittery', 'Headache', 'Hypersomnia', 'Malaise', 'Nausea', 'Pain']",1,PFIZER\BIONTECH, 938085,MD,61.0,M,"High fever; Vomiting; Severe fatigue; Weakness; This is a spontaneous report from a contactable physician (patient himself). This 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1442), via intramuscular, on 05Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 61-year-old. Vaccine location was deltoid left. The subject did not have a relevant medical history and concomitant medications. On 06Jan2021, the patient developed high fever, vomiting, severe fatigue and weakness. He did not experience anaphylaxis. The events were considered serious as medically significant. The patient stated that side effects mentioned lasted 3 hours and he felt much better now. However, the final clinical outcome was unknown. The patient is not sure if he should get the shot again in 3 weeks since he was really sick. The reporting physician considered the events 'high fever', 'vomiting', 'severe fatigue' and 'weakness' related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia, vomiting, fatigue and asthenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Asthenia', 'Fatigue', 'Malaise', 'Pyrexia', 'Vomiting']",UNK,PFIZER\BIONTECH,OT 938087,FL,34.0,F,"feeling of fullness in her ear; it felt like fluid in her right ear; Hearing loss in right ear; Soreness in the left arm; This is a spontaneous report from a contactable Other-HCP. A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EH9899) 16Dec2020 at 07:40AM in the left arm at single dose via intramuscular for COVID-19 immunization. Medical history included seasonal allergy. Concomitant medications included fluticasone propionate for seasonal allergy. The day after vaccination she noticed soreness of the left arm. Then two days later she noticed hearing loss secondary to a feeling of fullness in her ear; it felt like fluid in her right ear which has improved and she states it was not serious after the first dose. Patient received the second dose of vaccine on 04Jan2021 at 08:00AM in the left arm. That night she experienced myalgia, fever, chills, back pain, and started with a constant ringing in her right ear and the hearing loss that worsened from before (reported under AER 2021012152. All of these effects have resolved except the hearing loss and ringing in her ear. Additionally she went to see an ENT doctor and get a hearing test. The Hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She was currently being treated with 80mg of Prednisone daily by mouth and getting Dexamethasone injections to her middle eardrum. Patient informed that on 17Dec2020 she was tested for COVID 19 with the PCR test due to an exposure at work. The result was negative. The patient recovered from soreness in the left arm on 19Dec2020. The patient had not yet recovered from deafness.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events ear congestion and hearing loss unilateral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/17/2020,1.0,PVT,FLONASE [FLUTICASONE PROPIONATE],,Medical History/Concurrent Conditions: Seasonal allergy,,,"['Acoustic stimulation tests abnormal', 'Audiogram abnormal', 'Back pain', 'Chills', 'Deafness unilateral', 'Ear discomfort', 'Exposure to SARS-CoV-2', 'Middle ear effusion', 'Myalgia', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tinnitus']",1,PFIZER\BIONTECH, 938089,FL,34.0,F,"constant ringing in right ear; Myalgia; Fever; Chills; back pain; Inappropriate schedule of vaccine administered; hearing loss that worsened from before; hearing loss that worsened from before; This is a spontaneous report from a contactable physician (patient). This 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EH9899), via an unspecified route of administration, on 04Jan2021 at 08:00AM at single dose for COVID-19 immunisation. The first dose was received on 16Dec2020 at 7:40 AM at single dose. Vaccine location was in the left arm. The patient was vaccinated at hospital, age at vaccination was 34-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications included ongoing fluticasone proprionate (FLONASE) for seasonal allergy taking for two years. On 17Dec2020, COVID-19 PCR test was negative. On 04Jan2021 at night, she experienced myalgia, fever, chills, back pain and started with a constant ringing in her right ear and the hearing loss that worsened from before (started on 18Dec2020 after first dose, see AER # 2021012126). Start date of constant ringing in right ear was 05Jan2021. The events resulted in Physician Office visit. Hearing loss in right ear worsened and constant ringing in right ear were reported serious as medically significant while the other events were reported as non-serious. She went to see an ENT doctor and get a hearing test. The hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She is currently being treated with 80mg of Prednisone daily by mouth and getting dexamethasone injections to her middle eardrum. All of these effects have resolved except the hearing loss and ringing in her ear. All the events were considered related to the vaccine per reporter.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/01/2021,,PVT,FLONASE [FLUTICASONE PROPIONATE],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Acoustic stimulation tests abnormal', 'Audiogram abnormal', 'Back pain', 'Chills', 'Deafness', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tinnitus']",2,PFIZER\BIONTECH, 938090,CO,54.0,F,"fever of 103.7; Cough; body aches; Joint pain; chills; This is a spontaneous report from a contactable Nurse reporting for herself. A 54-year-old female patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at single dose in left deltoid for COVID-19 immunisation at the age of 54-year-old. Lot number was EL1284. Medical history included Asthma since 1991 and ongoing, high blood pressure since 2020 (6 months before the report) and ongoing. Concomitant medications were unknown. On 07Jan2021, the patient experienced fever of 103.7 at 1:30PM, chills at 9:00AM, body aches at 11:00AM, Joint pain at 09:00AM, cough at 1:00PM; the events were considered medically significant. The patient was not treated for the events. On 13Nov2020, test showed she had COVID-19. On 07Jan2021, body temperature was 103.7 Fahrenheit. The patient did not recover from the events. The nurse considered the events were related to suspect vaccine.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,UNK,,Asthma; Blood pressure high (Diagnosed 6 months before the report),,,,"['Arthralgia', 'Chills', 'Cough', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,OT 938091,IL,50.0,F,"Hypokalemia; Hypomagnesemia; Hypocalcemia; Hemoglobin dropped little bit; Tetany; Muscle cramps; This is a spontaneous report from a contactable healthcare professional, a physician assistant. A 50-year-old female patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 18Dec2020 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history included tachycardia, tension headache, and glucose tolerance impaired. Concomitant medications included rosuvastatin calcium (CRESTOR), gabapentin (MANUFACTURER UNKNOWN), and metoprolol (MANUFACTURER UNKNOWN). On 18Dec2020, the patient experienced hypokalemia, hypomagnesemia, hypocalcemia, tetany, muscle cramps, and hemoglobin dropped little bit. The clinical course was as follows: The patient received the vaccine and about 30 minutes later she started to ""feel bad"". She went to the urgent care and about an hour after they took her to the emergency room (also reported as hospital). She had a complete blood count, complete metabolic panel, and magnesium level done on the 18th, 21th, 23rd, 26th, 28th, 30th of Dec2020 and then again on 04Jan2021. On 18Dec2020, her initial lab test showed potassium: 2.6, hemoglobin: 10.2, magnesium: 1.2, and calcium: 5.7. The physician assistant reported that a potassium of 2.6 was critically low and a hemoglobin was 10.2 was about normal for the patient. She received oral medications of potassium 20 mEq twice a day and calcium and magnesium supplements once a day. On 04Jan2021, lab data showed: potassium: 4.2, magnesium: 2.1, calcium: 9.5 and hemoglobin: 14.5. Per the reporting physician assistant, the above levels went back to normal but stated she had to be supplemented to get back to that point. The clinical outcomes of the hypokalemia, hypomagnesemia, hypocalcemia, and hemoglobin dropped little bit were recovered on 04Jan2021; while that of the tetany and muscle cramps, were unknown. The physician assistant assessed the events as related to the suspect vaccine. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,CRESTOR; ;,,Medical History/Concurrent Conditions: Glucose tolerance impaired; Tachycardia; Tension headaches,,,"['Blood calcium decreased', 'Blood magnesium decreased', 'Blood potassium decreased', 'Feeling abnormal', 'Full blood count', 'Haemoglobin decreased', 'Hypocalcaemia', 'Hypokalaemia', 'Hypomagnesaemia', 'Metabolic function test', 'Muscle spasms', 'Tetany']",UNK,PFIZER\BIONTECH, 938093,,,U,"patient felt tingling in their neck, arms and hand and then few days later it went to their feet; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number and Expiration Date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient felt tingling in their neck, arms and hand and then few days later it went to their feet (medically significant). The clinical outcome of the event was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Paraesthesia'],UNK,PFIZER\BIONTECH, 938094,,,F,"Bell's palsy; Flu like symptoms; This is a spontaneous report from a non-contactable consumer reported that a female patient of an unspecified age received bnt162b2, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. It was reported that the patient got Bell's palsy four days after the vaccine and had flu-like symptoms for two weeks. Added that patient is completely symptom free at the time of report. The outcome of the events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Facial paralysis', 'Influenza like illness']",UNK,PFIZER\BIONTECH, 938095,PA,45.0,F,"Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; My whole body was as if I was sun burnt; My heart started to race; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2, (Pfizer COVID Vaccine, lot number: EK9231, expiry date: Apr2021) intramuscular on an unspecified date at single dose on right arm for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included nortriptyline for migraine, botulinum toxin type a (BOTOX) for migraine and birth control medication. The patient stated that, ""I was wondering if this was a reaction to the vaccination I had today. So I ended up 3 hours after I received the vaccine, I got very hot and clammy but at the same time had the goosebumps and then my whole body was as if I was sun burnt and my heart started to race. And then my whole body was red as if I had a sunburn. Actually I went to the ER today and they just did lab work because of the way I was feeling. All they gave me in the emergency room is IV fluids."" Therapeutic measures taken as a result of the events included IV fluids. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,; BOTOX,,Medical History/Concurrent Conditions: Migraine,,,"['Cold sweat', 'Erythema', 'Feeling hot', 'Laboratory test', 'Palpitations', 'Piloerection']",UNK,PFIZER\BIONTECH,OT 938097,,,U,"died; This is a spontaneous report from a non-contactable consumer via a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported the patient was a doctor, died after the vaccine with no apparent disease. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],UNK,PFIZER\BIONTECH, 938104,,70.0,M,COVID-19 positive and admitted to hospital 6 days post-vaccination,Not Reported,,Not Reported,Yes,,Not Reported,,12/22/2020,12/28/2020,6.0,PVT,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH,IM 938109,IA,43.0,M,"Received first dose Moderna COVID vaccine on 12/28/2020; on that same day 12/28 he noticed a dry cough; on 1/1/2021 he reported fever, chills, body aches, Headache, sinus congestion. On 1/1/2021 he tested positive for COVID-19, he reported being with a family member on Christmas who had COVID symptoms. On 1/11/2021 he required hospitalization for COVID-19 pneumonia",Not Reported,,Not Reported,Yes,,Not Reported,N,12/31/2020,01/01/2021,1.0,WRK,,,,,,"['COVID-19 pneumonia', 'Chills', 'Cough', 'Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive', 'Sinus congestion']",1,MODERNA,IM 938118,MI,51.0,F,"on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm",Yes,01/10/2021,Yes,Yes,2.0,Not Reported,N,01/05/2021,01/08/2021,3.0,PUB,multivitamin; vitamin D,none mentioned,no significant past medical history,,latex,"['Abdominal X-ray', 'Aneurysm', 'Angiogram cerebral', 'Arteriogram carotid', 'Cerebellar haemorrhage', 'Cerebrovascular accident', 'Chest X-ray', 'Computerised tomogram abdomen', 'Computerised tomogram head', 'Computerised tomogram pelvis', 'Computerised tomogram spine', 'Computerised tomogram thorax']",1,PFIZER\BIONTECH,IM 938126,NY,32.0,M,"Following the first COVID vaccine dose on Dec/18/2020, I had headaches that started on the third day and ended on the tenth day. The headaches were usually light, unilateral, and alternating from one side to the other. I was usually functional except on the fourth and seventh days where the headaches were moderate to severe, and I took naps to help with the headaches for those two days. I have never had an issue with headaches before, and these symptoms were a new experience for me. I did not take any medications as treatment for the headaches. Following the second COVID vaccine dose on January/7/2021, I felt fatigue and generalized muscle aches within six to twelve hours, and these symptoms lasted for two days. On January/10/2021, when I woke up that morning I again felt light, unilateral, and alternating headaches. In addition, I noticed that I was unable to move the left side of my face. I felt moderate tingling sensations associated with the distribution of the paralysis. When I looked in the mirror, I could quite noticeably see asymmetry in my face. I immediately went to the emergency department at the hospital where my primary care doctor is located. I was kept in the hospital into the next day for observation. After evaluation by a neurology team and an MRI, I was provided with the diagnosis of Bells Palsy. I have never previously been diagnosed with Bells Palsy, and I have never previously had a hospital stay before. The doctors prescribed medications which I am currently taking. As of today January/12/2021, the symptoms have had some improvement, but the symptoms still continue.",Not Reported,,Not Reported,Yes,2.0,Yes,,01/07/2021,01/10/2021,3.0,UNK,none,none,none,,none,"['Facial asymmetry', 'Facial paralysis', 'Fatigue', 'Headache', 'Myalgia', 'Paraesthesia']",2,PFIZER\BIONTECH, 938184,OR,38.0,F,"Became very hot, flushing, dizziness, lightheaded, felt like passing out. Followed by jaw tightness and pain, tongue swelling, lip swelling, difficulty breathing, chest tightness, fast heartbeat, increased blood pressure. Given benadryl, epi, solu-medrol and pepcid. Kept for observation. After release, continuing to have intermittent hot flashes, itching all over face and body, occasional jaw tightness, sore throat and tongue, increase in pulse, O2 sats in low 90s,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,PVT,Zyrtec Singulair,,Allergies Asthma,,"Latex, bees, (Food Pollen Allergy Syndrome)= most fresh fruits and veggies, tree nuts. Several environmental allergies like pollen, mold, trees, animals.","['Blood pressure increased', 'Chest discomfort', 'Dizziness', 'Dyspnoea', 'Feeling hot', 'Flushing', 'Glossodynia', 'Heart rate increased', 'Joint stiffness', 'Lip swelling', 'Oropharyngeal pain', 'Oxygen saturation decreased', 'Pain in jaw', 'Presyncope', 'Pruritus', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 938235,NJ,40.0,M,"Beginning at 6:30 am on 1/8, two days following vaccination, the individual was driving to work and began to experience nausea while at a traffic light. He pulled over and threw up. Once he got to work he vomited again. He drove to another facility for work and then threw up 3 or 4 more times. He began experiencing hot flashes at this time. He went to the hospital and was seen in the emergency room. He threw up several more times in the ER and stated that his heart was racing and that he had diarrhea. The emergency room gave him medications for the nausea and he stayed there for 2 or 3 hours. He began to feel better and was discharged to home.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/06/2021,01/08/2021,2.0,PUB,None,None at the time of vaccination. Up to one month prior the individual had a cold described as coughing and sneezing,None,,"None, possibly penicillin","['Blood test normal', 'Diarrhoea', 'Electrocardiogram normal', 'Hot flush', 'Nausea', 'Palpitations', 'Vomiting']",1,MODERNA,IM 938256,NY,53.0,F,"Immediately developed intense burning that progressed over the next 30 minutes and continued to burn for 3 days. The next day progressive extreme fatigue last 4 days. felt like it was going to pass out. full on body pain, dizzy and lightheaded. need assistance to get to the walk, intense headache.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/06/2021,01/06/2021,0.0,WRK,Vyvanse 40mg daily took that morning. mvi and calcium 600mg OTC. Generic Voltaran 1% gel apply once a day.,none,Takes medications for weight loss Chronic neck and right shoulder pain,,"Penicillin, erythromycin.","['Blood test normal', 'Burning sensation', 'Chest X-ray normal', 'Dizziness', 'Electrocardiogram normal', 'Fatigue', 'Gait disturbance', 'Headache', 'Immediate post-injection reaction', 'Pain', 'Syncope', 'Ultrasound scan normal']",1,MODERNA,IM 938258,PA,48.0,F,"Very large, reddened, tender area at injection site (like the size of an angry red egg), and fever of 103.2.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,12/26/2020,12/27/2020,1.0,PVT,,,,,"Aspirin, barbiturates, NSAIDs","['Injection site erythema', 'Injection site pain', 'Pyrexia']",1,MODERNA, 938301,CA,50.0,F,"GIVEN ON 12/23. SORENESS FELT ON LEFT ARM SITE THE NEXT DAY, WITH DECREASED MOBILITY AND STRENGTH DUE TO SEVERE SORENESS AND PAIN. PAIN PROGRESSIVELY LESSENED BUT THE SORENESS STILL VERY APPARENT. ON 1/5, SPOKE TO PRIMARY MD, XRAY ON LEFT SHOULDER DONE ON 1/6. ON 1/7, STIFFNESS WITH SEVERE PAIN UPON MOVEMENT NOTED ESP IN THE MORNING. ULTRASOUND WAS DONE ON 1/8, NOTED BICEPS TENOSYNOVITIS. ORTHOPEDIC SURGEON SEEN ON 1/11, W DX OF ADHESIVE CAPSULITIS, SUGGESTED FOR PT FOR NOW, AND OFF WORK, AND TO BE FOLLOWED UP ON 2/1 BY SAME ORTHO SURGEON. WILL NOT OFFER CORTISONE SHOT FOR NOW AS IT MAY COMPROMISED OR WEAKEN IMMUNE RESPONSE, IN WHICH MY SECOND COVID SHOT DUE ON THE 15TH OF JANUARY. FIRST APPT FOR PT ON 1/15",Not Reported,,Not Reported,Not Reported,,Yes,N,12/23/2020,12/24/2020,1.0,PVT,"FIRST COVID SHOT GIVEN ON 12/23. SORENESS FELT ON LEFT ARM SITE THE NEXT DAY, WITH DECREASED MOBILITY AND STRENGTH DUE TO SEVERE SORENESS AND PAIN. PAIN PROGRESSIVELY LESSENED BUT THE SORENESS STILL VERY APPARENT. ON 1/5, SPOKE TO PRIMARY M",NONE,,,CODEINE,"['Asthenia', 'Impaired work ability', 'Injected limb mobility decreased', 'Injection site pain', 'Musculoskeletal stiffness', 'Pain', 'Periarthritis', 'Tenosynovitis', 'Ultrasound scan abnormal', 'X-ray limb']",1,PFIZER\BIONTECH,IM 938310,CO,37.0,F,Sudden hearing loss right ear accompanied by tinnitus,Not Reported,,Not Reported,Not Reported,,Yes,N,12/31/2020,01/10/2021,10.0,PVT,Levothyroxine,,,,Latex,"['Acoustic stimulation tests abnormal', 'Deafness unilateral', 'Sudden hearing loss', 'Tinnitus']",1,MODERNA, 938361,IL,53.0,M,"Patient presented on the morning of 1/10/2021 with swollen lips and hives. Vaccination took place on Wednesday January 6th, 2021.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/06/2021,01/10/2021,4.0,PHM,"Cetirizine 10mg - 1 daily, Fluoxetine 40mg - 1 daily, Jardiance 10mg - 1 Daily, Pazeo 0.7% eye drop - 1 drop into both eyes once daily, Famotidine 20mg - 1 twice daily, Fluticasone 50mcg nasal spray - 1 spray in each nostril twice daily, Gl",Positive COVID 19 on 11/30/2020,"Moderate Intellectually disabled, Non-Insulin Dependent Diabetes Mellitus, HTN, high cholesterol, schizophrenia, tachycardia, acid reflux",,Bee venom,"['Lip swelling', 'Urticaria']",1,MODERNA,IM 938397,KS,57.0,F,"Patient had mild bilateral knee and hip pain 1 month ago, then she received her 1st dose of COVID vaccine on 12/14/20. Her joint pain worsened then on 1/4/21 she received her 2nd dose of COIVD vaccine on 1/4/21 and then her pain increased in spread up to her shoulders. She was seen at immediate care on 1/11/21 because her joint pain had worsened throughout and her shoulder pain was making it difficult to raise her arms above the level of her shoulders. Her pain was made worse w/ movement.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/04/2021,01/11/2021,7.0,PVT,,,,,,"['Arthralgia', 'C-reactive protein increased', 'Condition aggravated', 'Fibrin D dimer increased', 'Joint range of motion decreased', 'Neutrophil percentage increased', 'Pain', 'Platelet count increased', 'Red blood cell sedimentation rate increased']",2,PFIZER\BIONTECH,IM 938425,TX,44.0,F,"Woke up on 1/6/2021 with hot flashes, palpitations, dizziness and heart racing. Went to urgent care and they did an EKG which showed A-Fib, so I was sent to the ER and from there, I was transferred to an ICU at a different facility . I stayed until 1/8/2021. No cause was found and no history of A-Fib or family history.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,12/30/2020,01/06/2021,7.0,PVT,Zyrtec,None,None,,"Reglan, Bactrim, Augmentin","['Atrial fibrillation', 'Blood test', 'Dizziness', 'Echocardiogram', 'Electrocardiogram abnormal', 'Hot flush', 'Intensive care', 'Palpitations']",1,MODERNA,IM 938443,AR,52.0,F,"immediate tingling of lips, followed by fullness of posterior oropharynx, hoarseness and pruritus",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"allegra 180mg po qd, welbutrin xl 300mg po qam, fluoxetine 40mg po qam, synthroid 0.125mg po qam, lasix 40mg po qam, kcl 20mEq po qam, flonase 2sprays each nostril daily, dulera 2 puffs qd-bid, vitamin D 50000IU q week","viral symtpoms 1 week before-fatigue, cough, rhinorrhea, myalgias, COVID test (roche) negative antibodies to covid drawn in ED after reaction-negative",hypothyroidism migraines obesity allergies asthma mild intermittent,,bactrim anaphylaxis avocado angioedema allergy shots-anyphylaxis,"['Dysphonia', 'Immediate post-injection reaction', 'Oropharyngeal discomfort', 'Paraesthesia oral', 'Pruritus', 'SARS-CoV-2 antibody test negative']",1,MODERNA, 938446,IA,20.0,F,"Fever (103-104 oF) and 4""x1"" red, swelling area around site of injection. Pt states she received an IV.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/06/2021,01/07/2021,1.0,SEN,,,,,,"['Injection site erythema', 'Injection site swelling', 'Pyrexia']",1,MODERNA,IM 938450,AK,60.0,F,"Approximately 1 hour after vaccine pt developed flushing, swelling & rash around shot site. 1 hive was visualized on lower part of deltoid away from shot site. Pt took 25 mg Benadryl. BP was initially elevated during observation period (175/107) however decreased over the course of an hour to 155/94.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,Atenolol Hydrochlorothiazide,unknown,hypertension,,"Sensitivity to wine (flushing), seasoning & spices cause sneezing, congestion, cough","['Flushing', 'Injection site rash', 'Injection site swelling', 'Urticaria']",1,MODERNA,IM 938471,MD,56.0,F,"Date/time/when adverse event started: 12/31/20 noticed a white streak noted from R eyelid straight down to the R jaw. Numbness, tingling feeling from R mid cheek moving toward R ear. Swelling of the face at this site as well. Paresthesia feeling, abnormal sensations at this same area of the face. These issues continues even to today. Initially, I experienced a H/A on the R sided above my eye which has not been occurring lately. On 1/8/21 I was seen by the NP at and was dx. with Bell?s Palsy. The NP noticed that when I initially speak my mouth doesn?t move properly, but once I get my words started then my mouth moves properly. My smile is noticed to be abnormal. The NP then sent me to ER for evaluation with the dx. Of Bell?s Palsy and because of another potential medical condition there?s a high risk for a stroke. A CT scan and blood work were obtained. A f/u script for a MRI of the brain has been ordered as well. Discharge paperwork states: Bell?s Palsy. Currently, I am taking a tapering dose of Prednisone and Valtrex as prescribed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/31/2020,5.0,SEN,General MVIs. Prolia injection o 12/1/20. Calcium with Vitamin D3.,No,Osteoporosis,,"ASA, crab, fish, dog dander","['Computerised tomogram normal', 'Eyelid ptosis', 'Facial paralysis', 'Hypoaesthesia', 'Paraesthesia', 'Swelling face']",UNK,PFIZER\BIONTECH,IM 938482,,61.0,U,Acute approximate respiratory failure secondary to acute COPD,Not Reported,,Not Reported,Yes,2.0,Not Reported,,12/30/2020,01/01/2021,2.0,UNK,,,,,,"['Acute respiratory failure', 'Chronic obstructive pulmonary disease']",1,MODERNA,IM 938507,SD,45.0,M,"Pt received immunization around 1630. He was monitored after immunization for 15min with no side effects. Pt woke up at 7AM on 1/721 with sweats, chills, shaking, bodyaches and fatigue. Reports increased back pain and dizziness on Friday. Did take Acetaminophen with some pain relief. Felt better Sunday. Complains of some fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,Tramadol 50mg Propanolol 40mg/20mg BID,None,none,,NKA,"['Back pain', 'Dizziness', 'Fatigue', 'Hyperhidrosis', 'Pain', 'Tremor']",1,MODERNA,IM 938523,,30.0,F,"Pt reported her chest hurt, dizziness, chest tightness, heart racing, anxious, shaky. Shaky voice, inc. RR, elevated BP & HR, O2 Sat 99%, diaphoretic. vs monitored, pt laid down, practiced pursed lip breathing. 22 min after symptoms reported, pt began to improve. c/w vasovagal response. pt d/c feeling well/stable condition 1hr after symptoms first reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,"['Anxiety', 'Blood pressure increased', 'Chest discomfort', 'Chest pain', 'Dizziness', 'Dysphonia', 'Heart rate increased', 'Hyperhidrosis', 'Palpitations', 'Presyncope', 'Respiratory rate increased', 'Tremor']",1,MODERNA,IM 938524,NY,43.0,F,"first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, then 9 am hives everywhere, trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv fluids were influsing and epi drip started, went to ICU",Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/08/2021,01/11/2021,3.0,PVT,"mg, vit b complex, calicum with vit D, zyrtec, singulair, klonopin, omeprazole, prednisone",non systemic vasculitis bilat feet,"asthma, seasonal allergies, feet non systemic vasculitis, colon polyps",,"peanuts, tree nuts, compazine, ct dye","['Anaphylactic reaction', 'Blood magnesium normal', 'Blood potassium decreased', 'Chest X-ray normal', 'Dyspnoea', 'Fibrin D dimer normal', 'Full blood count', 'Headache', 'Human chorionic gonadotropin negative', 'Intensive care', 'Metabolic function test abnormal', 'Nausea', 'Pain', 'Procalcitonin normal', 'Pruritus', 'Tachycardia', 'Urticaria', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 938534,NC,28.0,F,"Anaphylaxis Chest tightness started @ 6:00pm following vaccine. Developed wheezing in all lung fields (confirmed by MD.) Developed hives- Albuterol, Benadryl and epinephrine administered @ 700pm. EMS called and transported to Hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Zoloft 50mg, Prilosec 20mg, Singulair 10mg Zyrtec 10mg",0,Asthma,,tree nut,"['Anaphylactic reaction', 'Chest discomfort', 'Urticaria', 'Wheezing']",1,PFIZER\BIONTECH,IM 938535,TX,33.0,M,Soreness on day of injection - itchen at injection site 1/11/21 - Redness and small bump 1-11-21 - Redness and warmth increase 1-12-21 - Singular - hydrocortisone cream Employee was furthered evaluated by MD. Prescribed antibiotic. Follow up appt. scheduled 1-18-2021 with MD.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/11/2021,7.0,WRK,Multivitamin,none,none,,History of possible latex allergy,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,MODERNA,IM 938536,KY,74.0,F,"Pt states she woke up friday morning with fever, chills, fatigue, vomiting & diarrhea. Had previous contact @ 1wk ago with COVID (+) person Test negative 2x for COVID & 1x for flu. Has virtual appt with Dr. on Thursday.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/08/2021,1.0,PVT,,was in contact with COVID (+) person @ 1 wk prior to getting vaccine,,,"Demerol, nitroglycerin, Norco","['Chills', 'Diarrhoea', 'Fatigue', 'Influenza virus test negative', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting']",1,MODERNA,IM 938538,NY,37.0,F,Employee received shot on 1/8/2021; stated that she was not feeling well all weekend; she just felt off. This morning (1/11/2021) employee reported extremely dizzy. Employee went home.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/11/2021,3.0,PVT,None,12/18/2020 - evaluated in urgent care - not feeling well - negative for covid.,None,,None,"['Condition aggravated', 'Dizziness', 'Malaise']",1,MODERNA,IM 938539,MN,33.0,F,"Nearly immediately felt flush, developed hives and tachycardia. Was given benadryl by the vaccination team pharmacist which resolved reaction within a few minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,SEN,,,,,,"['Flushing', 'Tachycardia', 'Urticaria']",1,MODERNA,IM 938540,MD,51.0,U,"01/08/21 - 1700 Recieved Covid Moderna in L-upper arm 01/09/21 - 0900 Noticed Red Raised Lump 1/2"" diameter w-fevers & chills 01/10/21 - 0800 - L arm sore, Red Raised Hot Lump 2-5"" diameter Fever101 & chills 01/11/21 - 0800 - L arm sore continues Hot, red & raised 2.5"" diameter 01/12/21 - 0800 - L arm sore Hot, red, raised 3"" diameter",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,PVT,"Synthroid, Multi-vitamin, Advil",,Hypothyroid,,"Erythromycin, Codiene, Levaquin","['Chills', 'Injection site erythema', 'Injection site mass', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA, 938541,LA,24.0,M,"Approximately one hour after vaccination, patient arrived to the ED with complaints of throat itchiness, nausea, and a headache. No stridor/wheezing, no rash, lungs clear. Reports the same symptoms occurred after the first dose. Reports history of having COVID twice and was hospitalized the first time. Patient offered IV meds which he refused. Patient prescribed and given zofran 4mg disintergrating tablet, maalox plus 30ml, lidocaine viscous 2% solution 15ml, pepcid 40mg and benadryl capsule 50 mg. Upon reevaluation, states feels much better, throat no longer itching and GI cocktail helped. Discharged with EPIpen, prednisone 50 mg for 5 days, benedryl 25 mg every 6 hours as needed for itching and Zofran as needed. Patient to follow-up with PCP this week.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,01/11/2021,0.0,PVT,,,,,,"['Headache', 'Nausea', 'Throat irritation']",2,PFIZER\BIONTECH,IM 938542,TX,36.0,F,Myalgia after vaccine Then rash under (L) arm Appears like Zoster with lesion on back and underarm. TXT with Acyclovir (Herpes Zoster),Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,WRK,"Tylenol, Advil","cold, congestions (mild)",None,,None,"['Myalgia', 'Rash', 'Skin lesion']",2,PFIZER\BIONTECH,IM 938543,TX,43.0,F,"Rash Back (L) arm chest pruritic Nausea & vomiting. Swelling (L) arm Exam Rash as above external vesicle Txt corticosteroid, antihistamines",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,WRK,"metformin, Janunet ER, Farxiga, Crestor",No,Diabetic,,No,"['Blood glucose', 'Injection site erythema', 'Nausea', 'Peripheral swelling', 'Protein total', 'Rash', 'Rash vesicular', 'Urine analysis', 'Vomiting']",2,PFIZER\BIONTECH,IM 938544,TX,50.0,F,Red Rash full body on 1/8/21. Some Relief 1/9/21. Full Recovery 1/10/21 Benadryl dose for treatment of rash,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/08/2021,4.0,WRK,"Losartan-HCTZ, Metformin, Vit D3",None,"HTN, Diabetes",,NKA,"['Rash', 'Rash erythematous']",UNK,UNKNOWN MANUFACTURER,IM 938556,FL,67.0,M,"Swollen lymph nodes neck, (L) armpit + shoulder Rash - Red blotchy rash all over chest, Abdomen + Back",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PUB,See back notes -,NoNe,"HTN, Neuropathy High Cholesterol",,NoNe,"['Injection site lymphadenopathy', 'Lymphadenopathy', 'Rash', 'Rash erythematous', 'Rash macular']",1,MODERNA,IM 938574,CA,74.0,F,Pt started experiencing severe temperature night of 1/08/2021 with chills very fatigue. Severe all over the body.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,Not aware,Mild GI upset Tested Postive COVID I'm December,Fibromygial ; Hypothyroid,,"Dust, Mites","['Chills', 'Fatigue', 'Pyrexia']",1,PFIZER\BIONTECH,IM 938576,NJ,22.0,F,"Back pain, bilateral PE and DVT",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/06/2021,01/09/2021,3.0,PVT,None,None,None,,All seafood,"['Back pain', 'Blood test', 'Computerised tomogram', 'Deep vein thrombosis', 'Magnetic resonance imaging', 'Pulmonary embolism']",1,PFIZER\BIONTECH,SYR 938712,KS,36.0,F,"Patient states that she received her second vaccination and in the hours after she had flu-like symptoms. Then over the next few days, she started to notice tingling and a ""prickly"" sensation in various areas. This progressed to symmetric BLE weakness which started in her feet and had reached to just above her knees bilaterally time and she arrived. The weakness had progressed to her hips. She also noticed weakness in her arms and they are easily fatigued. She is able to walk but it takes much effort.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"Metformin, insulin, lisinopril, omeprazole, atorvastatin, propranolol","DM type II insulin dependent, hypertension, hyperlipidemia","Reactive airway disease, diabetes mellitus type II, PCOS (polycystic ovarian syndrome), muscle weakness postpartum course of weeks and months. Mother has an autoimmune disease.",,"codeine - hypersensitivity, diphenhydramine - hypersensitivity, iodinated contrast - nausea, trouble breathing, clindamycin - hives","['Blood glucose increased', 'Gait disturbance', 'Influenza like illness', 'Intervertebral disc protrusion', 'Magnetic resonance imaging spinal abnormal', 'Muscle fatigue', 'Muscular weakness', 'Paraesthesia', 'Red blood cell sedimentation rate increased', 'Respiratory rate']",2,PFIZER\BIONTECH,IM 938732,VA,32.0,F,"Received moderna vaccine 1/1/2021. On 1/11/2021 persistent tooth pain presented, upper and lower mouth. Pain has persisted for past 2 days (no improvement). 6-10 blister like painful and itchy bumps to head (only in areas covered by hair) presented on 1/11/2021, persistent.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/10/2021,9.0,PVT,Type 1 diabetic- taking Humalog (carb adjusted before meals) and NPR insulin (twice daily); prenatal vitamin,None,"Diabetes, type 1",,NKDA,"['Blister', 'Oral pain', 'Pruritus', 'Toothache']",1,MODERNA,IM 938808,,52.0,F,"coughing, flushing, cyanosis, diaphoresis",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,"codeine, Combivent",,"Behcet's syndrome, asthma, laryngeal spasms, Guillain-Barre, Raynaud's, GERD, anxiety/depression",,"quinolones, contrast media, linezolid, vancomycin, sulfa, shellfish, daptomycin, tocilizumab","['Cough', 'Cyanosis', 'Flushing', 'Hyperhidrosis']",1,MODERNA, 938820,AZ,30.0,M,"Within 3 minutes of receiving vaccine felt flush and throat swelling, responded to Epi Pen and Benadryl p.o. EMS took him to ED where he remained several hours receiving 1 liter NS 125 mg solumedrol IV, discharge with 4 days of prednisone 40 mg daily and a prescription for an Epi Pen. As of 1.12 he is totally okay with no after effects.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,None,None known,None known,,Ibuprofen,"['Flushing', 'Pharyngeal swelling']",1,MODERNA,IM 938829,MD,44.0,F,"First Day after the injection I had a headache and nausea the entire day into the next day. The second day I still had the headache and the nausea. I work overnights. When I awoke in the afternoon, my throat was closing up. It was hard to swallow and I struggled to breath. I immediately drank liquid Benadryl and called my doctor in the morning.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,WRK,"Valsarten, Hydrochlorothiazide",None,Type II Diabetes High Blood Pressure,Hepatitis A and B Vaccine,"Cinnamon, Veal, Lamb Nexium, Lisinopril","['Dysphagia', 'Dyspnoea', 'Headache', 'Nausea', 'Throat tightness']",1,PFIZER\BIONTECH,SYR 938833,OR,38.0,F,Patient presents to the Emergency Department who was doing well up until she received COVID-19 vaccine at 1150. 15 minutes later patient started to experience throat tightening and tongue swelling. She was administered Epipen at 1217 by staff at vaccination clinic. EMS was called and prior to arrival at ER tongue swelling had subsided.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,"Prednisone, Vicodin, Albuterol","['Swollen tongue', 'Throat tightness']",UNK,MODERNA, 938868,VA,34.0,F,"-0715 vaccine administered. -0735 started to feel dizzy/off and right side of tongue felt like it was mildly swelling and itchy. -0735 asked to have blood pressure taken as know when I am having anaphylaxis my blood pressure escalates. -0740 took blood pressure and it was 141/86 in right arm. Normal is 110s/60s-70s. No anxiety feelings. -0740 throat started to have increased mucous production. Had the tickle and tightness in throat. Asked and received 25mg Benadryl with cup of water. -0742 started clearing throat frequently and slight cough. Knew it was anaphylaxis and told the team I need to go to the ER. Asked for additional 25mg Benadryl. Also took 20mg Famotidine and 2 puffs Albuterol inhaler--this is my prescribed anaphylaxis routine. Had Epipens on standby. -0743 put on O2 saturation monitor and watched O2 drop into 90-92 range. Asked for epipen on standby as I know when I need to start it. Didn't want to take that when I knew I was about to get it in the ER and knowing self hadn't progressed that far. Felt chest tightness and shortness of breath. Voice started becoming hoarse. -0800 EMS arrived (delay as team didn't know if they were supposed to call 911 or a Code--they chose EMS even though in hospital). Then staff at COVID vaccine clinic kept emphasizing need to go in ambulance while EMS and self fought to go through hospital (much quicker route). Finally cleared to go through hospital to ER. To get some air via breathing in had to sit up leaning forward. Voice completely hoarse by this time. -About 0817 arrived to ER bay. At this time, frequently coughing and cough started to sound stridorous. Difficulty getting breaths in. Had chest pain near heart. Greeted by MD, 2 RNS, and technician. -0819 received IM epinephrine. Attached to 5 lead EKG monitoring and O2 monitoring. Blood pressure done again. Higher than previous. -About 0821 had working IV (previous two attempts failed as veins were constricting). Given IV Solumderol. Started bolus of 1L Normal Saline. -Not sure how long after by cough subsided, increased mucous production subsided, as well as hoarseness decreased. -Held for observation for 2hours (would be longer if not resolved). - Discharged around 1015. At this time, hoarseness almost all gone. Minimal throat clearing. Cough resolved. -Prescribed epipen inhalers (mine expired) and Prednisone. Prednisone is PRN for mild breathing difficulties if it starts again tomorrow 1/13/21. -At 1400 took 50mg Benadryl and 20mg Famotidine as previously prescribed for anaphylaxis maintenance. Will continue this as previously prescribed every 6hours until symptoms stay resolved. -Made follow up appointment with Primary Care Physician per protocol",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,PVT,"Lexapro, Synthroid, One-A-Day Prenatal Vitamins, Culturelle Women's Health probiotic, Flonase, Tylenol.",Seasonal allergies,"Anorexia nervosa, eczema, GERD, chronic low back pain, seasonal allergies. H/o anaphylaxis x2 in 2019 unknown etiology.","Allergic reaction with swelling, flushing, rash, migraine. And another was neurological changes. Third one was fainting, chills,","Latex sensitivity, sulfa antibiotics, Gardasil, Voltaren. Flu vaccine 2014. Soy intolerance, seasonal allergies. Pertussis vaccine in 1986. Had TDaP 12/2019 no r�action. Influenza vaccine 2014, had flu vaccine 2019 and 2020 no issues.","['Anaphylactic reaction', 'Blood pressure increased', 'Chest discomfort', 'Chest pain', 'Cough', 'Dizziness', 'Dysphonia', 'Dyspnoea', 'Electrocardiogram', 'Oxygen saturation decreased', 'Stridor', 'Swollen tongue', 'Throat clearing', 'Throat irritation', 'Throat tightness', 'Tongue pruritus']",1,PFIZER\BIONTECH,IM 938958,IL,30.0,F,"Immediately after she felt faint, heart rate 121, felt faint again bp 62/33. Was taken to the ER, within a half hour, she fully recovered. Vitals went back to normal.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/12/2021,01/12/2021,0.0,PVT,Vitamins,no,no,,no,"['Dizziness', 'Immediate post-injection reaction']",1,MODERNA,IM 938974,OH,88.0,M,"Hospice Resident received first Covid 19 vaccine dose on 1/6/21. 1/7/21 resident had decreased appetite noted in am but ate 100% of meal at dinner. 1/9/21 resident had decreased appetite with emesis x 2, loose BM x 2. Call placed to hospice. 1/10/21 5:44 am resident able to take HS meds, ingest 2 cups of shake. No emesis or loose stool noted. 12PM nurse noted resident not eating meals but ingesting milkshake and medications without any problems. Hospice contacted for change in condition. 1:00 pm hospice ordered Phenergan 12.5 mg Q 6 hrs PRN. Labs to be drawn 1/11/21. Hospice notified POA. 1/11/21 12:24am Resident had blood in stool. Resident denies any pain, on 2L of O2 for comfort.",Yes,01/11/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/11/2021,5.0,SEN,,Hospice,,,NKDA,"['Death', 'Decreased appetite', 'Diarrhoea', 'Haematemesis', 'Haematochezia', 'Haemoglobin decreased', 'Vomiting']",1,PFIZER\BIONTECH,IM 939006,IL,45.0,F,"Severely dizzy, left hand totally numb but painful, cold to touch. Felt better before she got to ER.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/12/2021,01/12/2021,0.0,PVT,Vitamins,no,no,reaction to HEP B,Hep B,"['Dizziness', 'Hypoaesthesia', 'Pain in extremity', 'Peripheral coldness']",1,MODERNA,IM 939036,NM,30.0,F,"Received vaccine when 20 weeks pregnant. After vaccine, started feeling heart palpitations. The following evening felt heart palpitations, tachycardia, dizzy, shaky, and impending sense of doom. Called 911. Vitals (blood pressure, heart rate, oxygenation, temperature), blood glucose, and heart rhythm were normal. No interventions made. Continued to have intermittent palpitations the following 2 weeks.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,UNK,"Prenatal vitamin daily, fexofenadine 180mg daily, vitamin D 4000 units daily, aspirin 81mg daily, folic acid 800mcg daily",None,None,,pine nuts,"['Anxiety', 'Blood glucose normal', 'Blood pressure normal', 'Body temperature normal', 'Dizziness', 'Heart rate normal', 'Nervousness', 'Oxygen saturation normal', 'Palpitations', 'Pregnancy']",1,MODERNA,IM 939050,NY,32.0,F,"Patient vaccinated on 12/28. Approximately one day later, develops cough and on azithromycin x 1 week. On 1/3, patient develops left-sided weakness and aphasia. Taken to the hospital, tested COVID+, required intubation -- acute hypoxic respiratory failure secondary to COVID - on H&P. Patient died on 1/4/21 at 7:20am.",Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,Unknown,Unknown,Morbid obesity and hypothyroidism,,Unknown,"['Aphasia', 'Cough', 'Death', 'Endotracheal intubation', 'Hemiparesis', 'Respiratory failure', 'SARS-CoV-2 test positive']",1,MODERNA,IM 939087,IN,67.0,F,Attempting to confirm which COVID 19 vaccine was given (Moderna or Pfizer). They did not send the record when they sent the patient to General ER the next am. Did not answer the phone.,Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/07/2021,01/08/2021,1.0,SEN,"Amlodipine, Cholecalciferol, Coumadin, Pantoprazole",Was staying at Rehab Center after having hip surgery after 12/20/2020 but unsure of exact date of surgery.,"Mass on brain, TIAs, Craniotomy 8/2018, HTN, cholecystectomy, appendectomy, tubal ligation, R total hip replacement, Hepatitis years ago, cancer of brain and lung, IVC filter, tonsillectomy",,NKA,"['Blood culture negative', 'Body temperature increased', 'CSF test normal', 'Mental status changes', 'Urine analysis normal', 'White blood cell count normal']",UNK,MODERNA,IM 939148,PA,52.0,F,"Lips and tongue became numb, throat felt itchy, severe nausea, headache, chest tightness, rash - first neck and face then rash progressed to a diffuse rash over entire body. I was on my way home and drove to Er and was seen. I was given Zolfran, Pepcid Solumedrol, Benadryl and Epinephrin.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,WRK,Synthroid Eliquis Adderall Multivitamin Vitamin C Vitamin D3 I just finished Augmentin for a sinus infection.,"sinus infection, asthma","3 Blood Clotting Disorders; Hypercoag - Factor V Leiden, Factor II, 20210A Mutation. Hypothyroid Migraines Chronic Sinusitis Asthma ADHD",,Bee stings Mushrooms Pine Nuts Ceclor Bactrim Compazine Reglan,"['Chest discomfort', 'Electrocardiogram', 'Headache', 'Hypoaesthesia oral', 'Nausea', 'Rash', 'Throat irritation']",2,PFIZER\BIONTECH,IM 939190,IL,32.0,F,"Started to feel lightheaded, weak, faint like I was going to pass out, heart rate increased, confusion, trouble speaking, brought to the ED, throat started to swell and started having thick spit and clearing my throat excessively. Diagnosed as anaphylaxis.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"Montelukast 10mg, magnesium 200mg",None,Asthma,,Dairy allergy,"['Anaphylactic reaction', 'Asthenia', 'Blood glucose', 'Confusional state', 'Dizziness', 'Electrocardiogram', 'Heart rate increased', 'Pharyngeal swelling', 'Saliva altered', 'Speech disorder', 'Throat clearing']",2,PFIZER\BIONTECH,SYR 939194,MN,32.0,F,"within 1 hr post-vaccine on 1/7 I had a mild headache that resolved with Tylenol. At about 12 hours post-vaccine I developed nausea, fever (100.4) and chills and secondary to this had poor sleep. The next day I took scheduled alternating Tylenol & ibuprofen during the day and then overnight 1 episode of chills that woke me up. no events Saturday or Sunday. Then Monday 1/11 in the early morning I started to develop a rash on my b/l elbow and right foot 3rd toe. I applied mometasone topical cream to these locations. while at work the rash extended down both forearms then by 5pm it was on both hips and extending along both legs. I applied Benadryl cream to the most irritated sites and took PO Benadryl 50mg at bedtime and again at 1am when the itching woke me up. I repeated Benadryl 25mg at 8am. The rash seems to be getting better on the arms but then by noon I had a new breakout on my neck and face. I took Benadryl 50mg at 1pm. The rash continued to have a rapid progression over the next hour and resulted in angioedema with my throat swelling, lips puffed and numb and eye swelling. I was injected with an epi pen and sent to the ED where I received PO prednisone, famotidine, and Benadryl. The face/neck rash then greatly improved and I was sent home on prednisone 40mg daily for 3 days.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/07/2021,01/11/2021,4.0,PVT,"metformin, Ocelle (cOCP), vit d, women's multivitamin, cholestyramine",none,PCOS,,shellfish- anaphylaxis,"['Angioedema', 'Chills', 'Eye swelling', 'Headache', 'Hypoaesthesia oral', 'Lip swelling', 'Nausea', 'Pharyngeal swelling', 'Poor quality sleep', 'Pruritus', 'Pyrexia', 'Rash', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 939216,NY,22.0,M,"Blurred vision, difficulty breathing (pale skin/blue lips), profuse sweating, muscle fatigue, headache. This lasted about 15 minutes. Until severity went down. Followed by 20 minutes of profuse sweating and headache. I thought I was going to die",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/08/2021,01/12/2021,4.0,OTH,,,,,,"['Cyanosis', 'Dyspnoea', 'Feeling abnormal', 'Headache', 'Hyperhidrosis', 'Muscle fatigue', 'Pallor', 'Vision blurred']",1,MODERNA,SYR 939270,HI,48.0,M,Sudden cardiac death,Yes,12/31/2020,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/31/2020,9.0,WRK,,,,,,['Sudden cardiac death'],1,PFIZER\BIONTECH,IM 939564,OH,29.0,F,"On 1/5/2020, I, the patient woke up at 3:30 with sharp boring epigastric pain. Progressed to include nausea. On evaluation in the ED was diagnosed with acute pancreatitis. Prior hx includes 2 episodes with hospitalization for gallstone pancreatitis in 2016. Subsequently had laparoscopic cholecystectomy in 2016. Last alcoholic beverage prior to 2020 ED presentation was 3 weeks prior. No tobacco or drug use.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,12/22/2020,01/05/2021,14.0,PVT,"Lexapro 20mg daily, Wellbutrin 300mg daily, Zyrtec OTC",None,,,Peanuts,"['Abdominal pain upper', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram pelvis abnormal', 'Lipase increased', 'Magnetic resonance cholangiopancreatography', 'Nausea', 'Pancreatitis acute']",1,MODERNA,IM 940190,OR,61.0,M,Joint stiffness & swelling Congestion Throat constricting,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,PEPCID; PLENDIL; fish oil; HYDRODIURIL; Magnesium Citrate; Melatonin; RITALIN; MULTIPLE VITAMINS ESSENTIAL; NIACOR; DELTASONE;,,"Adverse reaction to vaccine; Essential hypertension; Hyperlipidemia; S/P colostomy (HCC); Functional diarrhea; Incisional hernia, without obstruction or gangrene; Diverticular disease; Other hemorrhoids; ADHD; Occipital neuralgia of left side; Pain in both hands; Acute pain of right knee",,Lisinopril; Amlodipine,"['Joint stiffness', 'Joint swelling', 'Respiratory tract congestion', 'Throat tightness']",1,MODERNA,IM 940199,IL,,U,SMALL AMOUNT OF MIST NOTICED WHEN VACCINE WAS INSERTED. Not evaluated by me.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,,,PUB,,,,,,['Syringe issue'],UNK,MODERNA,IM 940267,IL,48.0,F,"1:22 pm pt c/o of heart racing, numbness of tongue and lips. Xarm feeling numb. 2:20 Symptoms resolving after benadryl & pepcid admin. 48 y/o female who presents with heart racing & numbness of tongues & lips. No other complaints No hx of allergic RXN Exam unremarkable Plan - home with observation. Possible allergic reaction - mild",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,none,none,none,,none,"['Hypoaesthesia oral', 'Injection site hypoaesthesia', 'Palpitations']",UNK,MODERNA,IM 940274,CA,51.0,M,Nauseated Mildly light headed D/C home 1550 - symptoms resolved,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,UNK,None,None,None,,"Sulfa, Codiene, Toradol","['Dizziness', 'Nausea']",2,PFIZER\BIONTECH,IM 940275,IL,32.0,U,Patient c/o tingling of face and pressure in the head. Pt states she has tingling of cheeks + head pressure. No other symptoms Exam - unremarkable by then Throat WNL Plan - F/u with PCP,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,None,No Reports COVID in Nov. 20,0,,None,"['Head discomfort', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 940283,NY,62.0,F,Pt complaint of nausea w/o vomiting 10 min post vaccination. Pt given Pedialyte for rehydration. BP - 116/77 V/S obtained WNL,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,PVT,naproxen - 500mg PRN tramadol - 10 mg cyclobenzaprine - 5 mg Xanax - 1 mg ER PRN,,chronic back pain,,MA,['Nausea'],1,MODERNA,IM 940301,CA,51.0,F,"Developed pain, redness and swelling (injection site) about 8-9 hrs. after receiving the vaccine. Symptoms increased day 2 with swelling as big as a lemon fruit. Day 3 - aside from pain & swelling at the injection site, I developed Left axillary lymphadenopathy. Day 4 - severe headache lip numbness & body ache Took Ibuprofen 400 mg each day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,None,None,,None,"['Headache', 'Hypoaesthesia oral', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy', 'Pain']",2,PFIZER\BIONTECH,IM 940314,,41.0,F,"Upon resting in waiting area after administration of vaccine, I began to notice left-sided facial numbness, extending to left shoulder / pectoris area. The symptom was mild throughout, did not get any worse. However, the symptoms have not subsided and I have continued to experience mild facial numbness (left). Yesterday, 01/07/21, I had an intermittent episode of tingling and left sided weakness which lasted a several hours in the afternoon. In addition to facial numbness, I also experienced left upper arm soreness, especially at site of injection. I also had a mild headache which lasted a three days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/19/2020,0.0,WRK,,,,,,"['Asthenia', 'Headache', 'Hemiparesis', 'Hypoaesthesia', 'Injection site pain', 'Pain in extremity', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 940669,NY,24.0,F,"Patient reports 7 days post vaccination raised, hive-like area. w/o pruritis that flattened over time and now presents as reddened area. Pt did not take any Benadryl for reaction. Pt concerned about second required series due 1/30/21 to where she will rcv medical advice.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/09/2021,7.0,WRK,,,,,sulfa antibiotics,"['Erythema', 'Swelling', 'Urticaria']",1,MODERNA,IM 963163,,88.0,M,Narrative:,Yes,01/08/2021,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/08/2021,2.0,OTH,,,,,,['Death'],1,MODERNA,IM 963164,,49.0,M,"Fever, Tachypnea, HYPERtension, Tachycardia & HYPERglycemia Narrative: Was inpatient overnight in a telemetry until. DC with diagnosis of DM and CHF",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/28/2020,12/29/2020,1.0,OTH,,,,,,"['Cardiac failure congestive', 'Diabetes mellitus', 'Hyperglycaemia', 'Hypertension', 'Pyrexia', 'Tachycardia', 'Tachypnoea']",1,MODERNA,IM 939377,CA,63.0,M,"COVID-19 PCR test/he was positive per the PCR test; COVID-19 PCR test/he was positive per the PCR test; Sweating; Fever; running to bathroom with urination every 15 minutes with a large amount of urine; running to bathroom with urination every 15 minutes with a large amount of urine; Heart pounding; tired and fatigue; Weight loss; Chills; pain all over the body; Sluggishness; This is a spontaneous report from a contactable consumer. A 63-years-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date was unknown), via an unspecified route of administration on the left arm on 21Dec2020 14:40, at a single dose for Covid 19. The patient's medical history and concomitant medications were not reported. The patient has no prior vaccinations -within 4 weeks. The patient is an EEG technician. On 22Dec2020, the patient reported the next day he started to feel sluggish, chills, tired/fatigue, pain all over his body, patient mentioned he has lost weight everyday since he got the shot from 153 pounds to 142 pounds; then on Wednesday evening 23Dec2020, it was a nightmare, he got sweating; fever with a high of 101.4 Fahrenheit; he was running to bathroom with urination every 15 minutes with a large amount of urine; and he was so tired and fatigued. Added when he was getting up all that night he was having night sweats up to five times a night and chills; and his heart was pounding. The urination, heart pounding resolved the next day. All of these events have improved at the time of report (now) or gone away but he is still sweating once at night for the last two days and he is tired and fatigued. He stated that he is scheduled for the second dose on 11Jan2021 and he is concerned if he should take the vaccine. He mentioned that he was tested for COVID 19 on 18Dec2020 and the result was inconclusive. He went again 23Dec2020 they called him on 25Dec2020 and informed he was positive per the PCR test. He treated himself with 500mg acetaminophen (UPC 0904672059; lot OBE2896 and expiration Oct2021) and azithromycin Z-Pack (NDC 65862-641-69; Lot ZYSA20012-A; and expiration date Mar2022). The sample of the product is not available to be returned. Predisposing factor was that the patient's wife was at home and was sick too at the same time. She was tested Sunday with no results yet. The outcome of the events of fever recovered on 28Dec2020, sluggishness recovered on 29Dec2020, pain all over the body was recovered on 02Jan2021; running to the bathroom with urination every 15 minutes with a large amount of urine and heart pounding were recovered on 24Dec2020, weight loss was not recovered, and for other events was recovering.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (4 days in this case). However, a causal relationship between event ""COVID-19 PCR test/he was positive per the PCR test"" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/22/2020,1.0,PVT,,,,,,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Night sweats', 'Pain', 'Palpitations', 'Pollakiuria', 'Pyrexia', 'SARS-CoV-2 test positive', 'Sluggishness', 'Weight decreased']",1,PFIZER\BIONTECH, 939378,FL,,F,"Tested positive to COVID; Tested positive to COVID; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Jan2021, the patient tested positive to Covid. The outcome of the event, tested positive to Covid, was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/02/2021,10.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 939379,TN,56.0,M,"neuropathy; pain; nausea; fatigue; bone, muscle, stomach pain; bone, muscle, stomach pain; bone, muscle, stomach pain; flare; increase in joint pain from his baseline; This is a spontaneous report from a Pfizer sponsored program Accredo Xeljanz Program. A contactable nurse and contactable consumer (patient) reported that a 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization and tofacitinib citrate (XELJANZ XR), orally from 02Oct2020 at 11 mg, daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. On 19Dec2020, the patient experienced neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare. In Dec2020, the patient experienced increase in joint pain from his baseline. The physician was aware. The patient was placed on unspecified steroids for the events, neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare which minimized symptoms. While weaning off steroids, the severity of symptoms returned. The patient was instructed by the doctor to stop taking tofacitinib citrate which was stopped on 29Dec2020. The action taken in response to the events for BNT162B2 was not applicable and for tofacitinib citrate was permanently withdrawn on 29Dec2020. The patient reported slight improvement after stopping tofacitinib citrate. The outcome of neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare was recovering and of increase in joint pain from his baseline was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available, the reported events are most likely due to patient underlying contributory factors and unlikely that it is related to the suspect product. However due to temporal association with the vaccine, a possible contributory role of vaccine cannot be ruled out. Case will be reevaluated based on additional information during the follow-up. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,10/02/2020,12/01/2020,60.0,UNK,XELJANZ XR,,,,,"['Abdominal pain upper', 'Arthralgia', 'Bone pain', 'Condition aggravated', 'Fatigue', 'Myalgia', 'Nausea', 'Neuropathy peripheral', 'Pain', 'Rheumatoid arthritis']",UNK,PFIZER\BIONTECH, 939382,NC,25.0,F,"I developed Covid -19 (positive PCR) on 02Jan2021 after respecting quarantine, mask wearing, and was not onsite at work; I developed Covid -19 (positive PCR) on 02Jan2021 after respecting quarantine, mask wearing, and was not onsite at work; This is a spontaneous report from a contactable pharmacist. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EK5130, via an unspecified route of administration at left arm from 23Dec2020 16:30 to 23Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient developed Covid-19 (positive polymerase chain reaction (PRC)) on 02Jan2021, after respecting quarantine, mask wearing, and was not onsite at work. The patient did not received treatment for the adverse events. The outcome of the events was recovering.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/02/2021,10.0,PVT,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 939385,MA,67.0,F,"she received her first dose of COVID vaccine on 18Dec and a week later contracted COVID; she received her first dose of COVID vaccine on 18Dec and a week later contracted COVID; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) from a contactable registered nurse (patient). This 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 18Dec2020 for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient stated she received her first dose of COVID vaccine on 18Dec and a week later contracted COVID (in Dec2020) after receiving COVID vaccine. She just wanted to find out the answer to some medical questions. She had questions about antibodies and whether or not she should take the second dose. She stated her second dose was scheduled in two days, on Friday. She said after being positive on 28Dec2020 for COVID-19 virus test, she received the medication Bamlanivumab 700 mg intravenous passive antibodies therapy to lessen the COVID symptoms and to keep her out of the hospital, which it did. The outcome of events was unknown. Information about lot and batch number was requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/01/2020,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 939393,MI,,M,"COVID Rapid Test and COVID-19 PCR test positive/ symptomatic/ fever/ not feeling well; COVID Rapid Test and COVID-19 PCR test positive/ symptomatic/ fever/ not feeling well; This is a spontaneous report from a Pfizer-sponsored Program Pfizer First Connect. A contactable nurse reported for a male patient (husband) with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via IM injection left deltoid on 19Dec2020 at single dose for COVID Prevention. Medical history and concomitant medications were none. The patient did not receive any other vaccines on the same day as the COVID vaccine. The patient was a healthcare professional. The vaccine was not specifically prescribed to the patient, but rather was given to him via his workplace policy, although it was not mandatory. The patient received 1st dose on 19Dec2020, and he had exposure to the virus at work, and on 01Jan2021 he woke up with a fever and was not feeling well and tested positive for COVID-19. Currently he is still symptomatic. The reporter is inquiring about how to follow up with the second dose for the patient, as the patient is due for his second dose on 09Jan2021. It was reported that it had mostly been a low grade fever. The patient had both COVID Rapid Test and COVID-19 PCR test performed on 01Jan2021, and both were positive. The outcome of event was unknown. The reporter was unsure of seriousness for the patient's positive COVID tests, so far it had not been terrible, but he was still symptomatic, so it was hard to say seriousness at this time. Relatedness of vaccine to event fever and positive COVID test both rapid and PCR from the reporter was unrelated.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,01/01/2021,13.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Malaise', 'Occupational exposure to SARS-CoV-2', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,OT 939398,,,F,"got the covid 19 vaccine on 29Dec2020 and tested positive for covid on 05Jan2021; got the covid 19 vaccine on 29Dec2020 and tested positive for covid on 05Jan2021; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (reported as ""Age-48, Unit-Unknown"") received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated she got the covid 19 vaccine on 29Dec2020 and tested positive for covid on 05Jan2021. She wanted to know what to do about the second dose of the vaccine. Information about Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/05/2021,7.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 939399,,,M,"I ended up testing positive on Monday 04Jan2021; I ended up testing positive on Monday 04Jan2021; This is a spontaneous report from a contactable Other Health Professional (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number was not reported, via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Family history included patient was ""99.9% sure that his daughter at day care had direct contact (COVID-19)"". It was reported that the patient received first dose on 30Dec2020, and that same Wednesday morning 99.9% sure that his daughter at day care had direct contact (COVID-19). He ended up testing positive on Monday 04Jan2021 with outcome of unknown, and was scheduled for second dose on 04Jan2021. He asked for specific recommendation for his weird situation. Information on Lot/Batch has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of suspected LOE and SARS-CoV-2 test positive due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/04/2021,5.0,UNK,,,Medical History/Concurrent Conditions: Exposure to COVID-19 (99.9% sure my daughter at day care had direct contact (COVID-19).),,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 939401,,53.0,F,"anaphylactic reaction; arm was really sore; tiredness; dizzy; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received bnt162b2 (Pfizer-biontech covid-19 vaccine), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunization. Medical history included shellfish allergy. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction on an unspecified date, dizzy on 31Dec2020, arm was really sore on an unspecified date, tiredness on an unspecified date. Event details: She was dizzy that day especially with changing positions, she didn't need to go to the doctor or anything. It wasn't severe. She was just a little dizzy. It's probably just the vaccine and it did go away. Her arm was really sore and went away after a few days. the tiredness, it wasn't a big deal. She did feel better about. it wasn't a serious anaphylactic reaction. It didn't happen right away. She had arm soreness. it wasn't immediate. She usually didn't have. It was really weird. She thought she was well hydrated. The outcome of event was really sore was resolved, outcome of other events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events due to temporal relationship. There is very limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Shellfish allergy,,,"['Anaphylactic reaction', 'Dizziness', 'Dizziness postural', 'Fatigue', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 939445,CA,41.0,F,"she tested positive for COVID-19 after receiving the first dose of the Pfizer-Biontech COVID-19 vaccine.; she tested positive for COVID-19 after receiving the first dose of the Pfizer-Biontech COVID-19 vaccine.; This is a spontaneous report from a contactable physician. A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) intramuscular in left arm on 26Dec2020 14:30 at a single dose for COVID-19 immunization.The patient's medical history and concomitant medications were not reported. The physician received her first dose of the COVID vaccine on 26Dec2020 and on 02Jan2021, tested positive for COVID. She actually tested negative 2 days before testing positive (26Dec2020). The outcome of the event was recovered on an unknown date. According to the physician, the event was unrelated to the vaccine as her nanny and her son was also tested positive.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tested positive for COVID, which is considered ineffective of BNT162B2, and the administration of BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,01/02/2021,7.0,UNK,,,,,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 939450,,,F,"Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable Registered Nurse (patient) via a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A female patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for COVID on an unspecified date with outcome of unknown. The patient just received the COVID vaccine, and also tested positive for COVID. The patient underwent lab tests and procedures which included COVID test: positive. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 939463,,55.0,M,"has COVID now and was pretty ill and in their ICU, positive COVID-19 test; has COVID now and was pretty ill and in their ICU, positive COVID-19 test; This is a spontaneous report from a contactable pharmacist. A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unspecified date in Dec2020 at SINGLE DOSE for COVID-19 immunization. The patient developed positive COVID-19 test with symptoms on unknown date. The clinical course was as follows: the patient received the first dose of the vaccine 2 weeks ago and has COVID now and was pretty ill and in their ICU. Laboratory data included: SARS-CoV-2 test (unknown date): positive. The pharmacist was wondering if the participants in the trials received their second dose if they tested positive before the second dose and if there is any data on when to give the second dose of the vaccine for patients that test positive before the second dose. The outcome of the events was unknown. Information on lot/batch number has been requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,,,UNK,,,,,,"['COVID-19', 'Illness', 'Intensive care', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 939464,,,F,"Anaphylactic reaction; Tongue was swelling; Difficulty breathing; This is a spontaneous report from a contactable Pharmacist. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at SINGLE DOSE for COVID-19 immunization. The patient experienced ""Tongue was swelling, Difficulty breathing, and an Anaphylactic reaction"".No other details provided. The outcome of the events was unknown Information on lot/batch number has been requested.; Sender's Comments: A possible causal relationship between acute onset of Anaphylactic reactions presented as Tongue swelling/Difficulty breathing and BNT162B2 cannot be completely ruled out considering the temporal relationship and the known adverse event profile of the suspect vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Anaphylactic reaction', 'Dyspnoea', 'Swollen tongue']",UNK,PFIZER\BIONTECH, 939492,NJ,50.0,M,"Positive COVID-19 rapid test; Positive COVID-19 rapid test; Positive COVID-19 rapid test; Patient got sick; 2 weeks of on and off fever and unproductive cough; Patient got sick; 2 weeks of on and off fever and unproductive cough; Patient got sick; 2 weeks of on and off fever and unproductive cough; Lost sense of taste and smell; Lost sense of taste and smell; sore throat; This is a spontaneous report from a contactable nurse (patient). A 50-year-old male patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on 16Dec2020, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. On 17Dec2020 patient got sick; 2 weeks of on and off fever and unproductive cough. In Dec2020 the patient also experienced lost sense of taste and smell. On 20Dec2020 the patient underwent COVID-19 rapid POC test and was found positive. The events required emergency room visit. Therapeutic measures were taken as a result of the events and included treatment with Tylenol 650 every 4 hours. The events recovered on unspecified date except unproductive cough and sore throat that were recovering. The information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (COVID-19 rapid POC test) with BNT162b2 can not be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/16/2020,12/01/2020,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Ageusia', 'Anosmia', 'Cough', 'Malaise', 'Oropharyngeal pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 939495,,,F,"Covid; Covid; This is a spontaneous report from a contactable Other Healthcare Professional (HCP). A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient was scheduled for her second dose of vaccine tomorrow (08Jan2021) but she was diagnosed with Covid on 07Jan2021. Outcome was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/07/2021,,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 939496,,,F,"Drug ineffective; tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist reporting for his/her mother-in-law. A 99-years-old female patient in good health received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on an unspecified date (presumably on 02Jan2021 - to be confirmed) at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included monoclonal antibody bamlanivimab on an unknown date. On 06Jan2021 the patient experienced tested positive for COVID-19. It was reported that the patient is scheduled to have her 2nd dose on 23Jan2021. The reporter asked if the patient should wait 90 days before taking the second dose. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between event and suspect BNT162B2 cannot be excluded",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/06/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 939501,,,F,"positive with covid; positive with covid; sinus strainagned at the back of the throat.; sinus strainagned at the back of the throat.; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on an unspecified date single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced positive with COVID on an unspecified date, sinus strainagned at the back of the throat on an unspecified date. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A causal association between reported ""positive with covid"" and suspect BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Paranasal sinus hypersecretion', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 939508,,,F,"received her 1st COVID vaccine shot 22Dec2020, however she got diagnosed with COVID; received her 1st COVID vaccine shot 22Dec2020, however she got diagnosed with COVID / pneumonia; rash; This is a spontaneous report from a contactable consumer (patient). This 77-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 22Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. After the first dose, the patient got diagnosed with COVID. She does not want to waste a second dose if it will not be useful. Everyone on her department has had COVID, and have been told to wait 3 months before getting their second dose. Caller had a 'rash' after her 1st dose of the COVID vaccine. The patient is now recuperating from the pneumonia. Outcome of pneumonia was recovering while outcome of the other events was unknown. Information on the Lot/Batch Number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,,,UNK,,,,,,"['COVID-19', 'Pneumonia', 'Rash']",1,PFIZER\BIONTECH, 939528,KY,53.0,M,"headaches on both sides of his head; This is a spontaneous report from a contactable Physician reporting for himself. A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 0.3ml single dose on 30Dec2020 in the left deltoid for COVID-19 immunisation at the age of 53-year-old. Lot number was EK9231, expiration date 30Apr2021. Medical history and concomitant medications were unknown. On 31Dec2020, headaches on both sides of his head; the event was considered medically significant. The patient received TYLENOL for the event. The patient did not recover from the event. The physician considered the event was related to suspect vaccine. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,UNK,,,,,,['Headache'],UNK,PFIZER\BIONTECH, 939553,,,M,"Received the first dose of Pfizer COVID Vaccine and then tested positive after receiving it; Received the first dose of Pfizer COVID Vaccine and then tested positive after receiving it; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of bnt162b2 (lot no. and expiry date were unknown), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Pfizer COVID Vaccine and then tested positive after receiving it. He says it has been 14 days after he tested positive and he is wondering about getting his second dose. The outcome of the event was unknown. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 939556,,,F,"increased respiratory infection; Allergic reaction; Yeast infection; Non-diagnosed allergic conjunctivitis; seasonal allergies; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs), from a contactable nurse (patient) reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was having an allergic reaction and had a yeast infection. She was supposed to get the next dose soon (on 12Jan2021) but she was worried about getting the second dose. The patient stated so she had some increased (incomplete sentence).The patient stated she had a non-diagnosed allergic conjunctivitis followed by a yeast infection, followed by increased respiratory infection and she did make a report of the seasonal allergies that I did not used to get at this time of year. So, she did not report the conjunctivitis because it was not diagnosed and did not report the yeast infection because she handled it herself. The outcome of events was unknown. Information about Lot/Batch number is requested.; Sender's Comments: Based solely on a compatible temporal association causality between reported events and BNT162B2 vaccine cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,UNK,,,,,,"['Conjunctivitis allergic', 'Fungal infection', 'Hypersensitivity', 'Respiratory tract infection']",1,PFIZER\BIONTECH, 939629,LA,79.0,F,"The patient presented to hospital on 1/6/2021 with a primary complaint of Fatigue (pt had covid vaccine yesterday. Now displaying increased weakness, blood in urine, increased confusion and urinated on herself today. Fever of 101.9 ) 79-year-old female presents to the emergency room with fatigue. The patient states yesterday she had the Moderna COVID-19 The patient states today she had a temperature 101.8� prior to arrival. Her son noted that she was having episodes of urinary frequency and also that she was profoundly weak and fatigued. They denied falling or hitting her head. The patient also states she been having nausea vomiting with diarrhea.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,"Amlodipine 10mg/day, Eliquis 2.5mg/day, Cyanocobalamine 1000mg Gabapentin 300/day, Lisinopril, 40mg/day, Metformin 500mg XR/day, Lopressor 25mg/day, Zofran 4mg/day, Protonix 40mg/day","Anticoagulant use, arthritis, asthma, AFib, bacteremia, CHG, lLumbar fractures, COPD, DM, DVT, Abcess, lung CA, Lupus, MRSA, Osteoporosis, PVD, Psoriasis, Sjorgrens, stroke, venous insufficiency of leg",See extensive list,,"Bactrim, Codeine, Methotrexate, PCN, Sulfamethox","['Asthenia', 'Blood creatinine increased', 'Blood glucose normal', 'Blood potassium increased', 'Blood urine present', 'Confusional state', 'Culture urine', 'Diarrhoea', 'Fatigue', 'Haematocrit decreased', 'Haemoglobin decreased', 'Nausea', 'Pollakiuria', 'Pyrexia', 'Urinary incontinence', 'Vomiting']",1,MODERNA,SYR 939654,VA,53.0,M,"Vaccine was given on 12/23/20 on 01/07.21 went to get a routine physical and received an emergency call that my pallet blood count was around 10K instead of 150k. Was instructed to go to the ER asap. However didn't received the message until the next morning at 6:30am. Was checked into the E.R. , given sterioids, pallets, hemogolibin. Stayed overnight in the hospital was able to leaved the next day around 1pm with pallets at 47k.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,12/23/2020,01/07/2021,15.0,PVT,"Allpurinol 100mg/day, amLopidine-olmesartan 4-40mg, atorvastatin 40mg",,fatty liver,,seasonal allegeries,"['Platelet count decreased', 'Platelet transfusion']",1,PFIZER\BIONTECH,IM 939757,NY,51.0,F,"swelling at the injection site, pain, headache, feeling like numb, change in the taste, fever the 1st day x2, body ache, lower back pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/11/2021,1.0,SCH,vitamins the day before.,Questionable fibromyalgia,none,,"Avelox, lyrica, gabapentin","['Back pain', 'Headache', 'Hypoaesthesia', 'Injection site swelling', 'Pain', 'Pyrexia', 'Taste disorder']",1,MODERNA,IM 939758,AZ,,U,"retinal edema; macular edema; macular pucker; neuralgia; Information has been received from a lawyer regarding a case in litigation concerning the currently approximately 72 years old patient (pt) of unknown gender. On or about 14-JUN-2012, the pt was administered the zoster vaccine live (ZOSTAVAX) (route, dose, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by a provider for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: neuralgia, retinal edema, macular edema and macular pucker. The outcome of the events was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, retinal edema, macular edema and macular pucker were determined to be medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,06/14/2012,,,PHM,,,,,,"['Macular fibrosis', 'Macular oedema', 'Neuralgia', 'Retinal oedema']",UNK,MERCK & CO. INC., 939766,PR,38.0,F,After 10 days injection area became red and hot,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/12/2021,10.0,PUB,Levoxyl 50,No,Hypothyroidism,,No,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,IM 939772,IN,38.0,F,"Patient vaccinated at 1715. Almost immediately after vaccination patient experienced dizziness and tongue tingling. Diphenhydramine 50 mg IM was administered at 1726. Patient progressed to swollen tongue and inability to swallow. Epinephrine 0.3 mg IM administered at 1800. Patient transported to ED. In ED patient received fluids, famotidine 20 mg at 1840, and dexamethasone 12 mg IV at 1858. Patient symptoms resolved and she was discharged.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,OTH,,,,,"Lisinopril, Tegretol","['Dizziness', 'Dysphagia', 'Paraesthesia oral', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 939845,IL,88.0,M,"Three hours after receiving COVID 19 vaccination, Patient oxygen level decreased to a critical level and went into cardiac arrest. Staff performed full code but was unable to bring back patient from cardiac arrest.",Yes,01/11/2021,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,PHM,,,CHF,,,"['Cardiac arrest', 'Oxygen saturation decreased']",1,PFIZER\BIONTECH,SYR 939914,AR,42.0,F,"2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took 50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged, Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I already had. I also continued my normal HS antihistamines. I had SOB on exertion, progressively better from the 6th-10th with it mostly resolved to yesterday. Body aches have continued but also progressively better. Yeasterday1/12/21 the Rx of prednisone was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg again and inhaler used. I have an appointment today to seek further care at my primary doctor's office. Asthmnax used again this morning as well, only mild tightness in the throat currently with mild body aches this whole time.",Not Reported,,Yes,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,Zyrtec 10 mg at HS Omeprazole 20mg at HS Estrodol 2mg at HS Multi Vit. GNC energy+metabolism x1 tab HS Asmanex HFA-2puffs swallowed PRN esophageal swelling /reflux-last used 2 plus months prior to vaccination,,seasonal allergies sensitive to high greases/fat content food=reflux lactose intolerance hormone replacement per post total hysterectomy 3/2018,,"Phenergan latex DMDM hydantion-a preservative in beauty products, Keflex Tamaflu","['Anxiety', 'Choking', 'Dysphagia', 'Dyspnoea', 'Dyspnoea exertional', 'Hypoaesthesia oral', 'Injection site paraesthesia', 'Mouth swelling', 'Pain', 'Paraesthesia', 'Paraesthesia oral', 'Pharyngeal hypoaesthesia', 'Pharyngeal paraesthesia', 'Pharyngeal swelling', 'Sleep disorder', 'Speech disorder', 'Swelling face', 'Throat tightness']",1,PFIZER\BIONTECH,IM 940067,MN,93.0,F,"Systemic: Fever-Severe, Systemic: hypotension, dyspnea-Severe; symptoms lasted 1 day",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,,,,,unknown,"['Dyspnoea', 'Hypotension', 'Pyrexia']",1,MODERNA,IM 940099,MS,34.0,F,Vaccine given on 1/9/21 around 12:45 pm in Left deltoid chest swelling started 5 to 6 hours later swelling in arm & neck with pain. Has been taken Ibuprofen & muscle relaxer. Symptoms still persistent on 1/12/21.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PUB,Nuvaring & Prozac,No,,,,"['Neck pain', 'Pain in extremity', 'Peripheral swelling', 'Swelling']",2,PFIZER\BIONTECH, 940103,TN,41.0,F,"fever loss of appetite headache/migraine body aches muscle cramps, rash",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,,Ulcerative colitis,flu vaccine itchy hives reaction treating 2 month,"Biaxin, Morphine, Bleach latex","['Decreased appetite', 'Headache', 'Migraine', 'Muscle spasms', 'Pain', 'Pyrexia', 'Rash']",2,PFIZER\BIONTECH,IM 940227,,,U,"anaphylaxis; A spontaneous report was received from a hospital CMO concerning a patient who was a frontline worker and received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date in Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 29 Dec 2020, it was reported that the frontline healthcare worker experienced anaphylaxis. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, anaphylaxis, was not reported.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting anaphylaxis. The event is possibly related to the vaccine, and additional information including temporal relationship between dosing and event and whether patient has history of anaphylaxis could provide details needed for medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Anaphylactic reaction'],1,MODERNA,OT 940228,,,U,"Anaphylaxis; A spontaneous report was received from a hospital CMO concerning a patient who was a frontline worker and received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date in Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 29 Dec 2020, it was reported that the frontline healthcare worker experienced anaphylaxis. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, anaphylaxis, was not reported.; Reporter's Comments: This case concerns a patient of unreported age and sex. The patient's medical history is not provided. The patient experienced anaphylaxis after receiving their first of two planned doses of mRNA-1273 (Lot unknown) on an unknown date. The event is possibly related to the vaccine, and additional information including temporal relationship between dosing and event and whether patient has previous history of anaphylaxis could provide details needed for medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Anaphylactic reaction'],1,UNKNOWN MANUFACTURER,OT 940351,NY,62.0,F,"Patient day after vaccination had fever, chills, headache and malaise but recovered the next day. starting four days after vaccination started to have left neck swelling . Of note day prior vaccination had left wisdom teeth removal and maxillary root canal. 1 week after vaccination and 8 days after oral procedures worsening left neck swelling, trouble swallowing's and change voice found resulting left neck 3x2cm necrotic neck abscess and significant neck inflammation. Patient was seen by ENT and started on IV Unysan and admitted for airway monitoring due to swelling with improvement over next 48 hours.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/05/2021,01/11/2021,6.0,PVT,None,Painful Lower right tooth,None,,None,"['Abscess neck', 'Blood culture negative', 'Blood lactic acid normal', 'C-reactive protein increased', 'Chills', 'Computerised tomogram neck', 'Dysphagia', 'Dysphonia', 'Full blood count normal', 'Headache', 'Inflammation', 'Malaise', 'Metabolic function test', 'Necrosis', 'Pyrexia', 'Red blood cell sedimentation rate increased', 'Swelling']",1,MODERNA,IM 940367,FL,53.0,F,"12/23/2020-RECEIVED VACCINE AT 9:52 AM. REPORTS NOT FEELING WELL IN THE AFTERNOON, LIGHTHEADED AND DIZZY, THROBBING HEADACHE. CRAMPING/ACHING IN BACK OF CALVES. 12/24/2020 CONTINUED WITH DIZZINESS, THROBBING HEADACHE, BLOOD PRESSURE ELEVATED, CHEST PRESSURE 8:00 PM REPORTED FEELING THAT SHE WAS GOING TO DIE, WENT TO LAKE CITY MEDICAL CENTER- BLOOD PRESSURE ON ARRIVAL 184/101 HR. 117. GIVEN NITRO AND MEDICATIONS. ADMITTED, DISCHARGED 48 HOURS LATER ON 12/26/2020. DISCHARGED ON BLOOD PRESSURE MEDICATION 12/27/2020-LESS THAN 24 HOURS AFTER BEING DISCHARGED SHE WAS READMITTED TO MEDICAL CENTER WITH SAME SYMPTOMS. 36 HOURS AFTER ADMISSION, TRANSFERRED TO MEDICAL CENTER. FOR CARDIC WORKUP AND HIGHER LEVEL OF CARE.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,"FIORICET, SUMATRIPTAN",NONE,"CLUSTER MIGRAINES,",,NONE,"['Blood pressure increased', 'Cardiac monitoring', 'Chest discomfort', 'Dizziness', 'Feeling abnormal', 'Headache', 'Laboratory test normal', 'Malaise', 'Muscle spasms']",1,PFIZER\BIONTECH,IM 940392,ME,43.0,F,"Became dizzy, headache, felt like she was going to faint, rigors and a temperature of 101.5. Next morning she had upset stomach, feeling dizzy, thought she was going to faint and a headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,SEN,Metoprolol 12.5 mg daily Baby Aspirin one daily,none,Heart condition,,none,"['Abdominal discomfort', 'Body temperature increased', 'Chills', 'Dizziness', 'Headache']",2,PFIZER\BIONTECH,IM 940402,NJ,38.0,F,"Got vaccine on 12/29/20. On 1/8/21 - developed raised, red 2inch x 2inch rash with smaller rash below it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/08/2021,10.0,PVT,"Birth control, Nexium, Celexa, lisopril",none,"HTN, anxiety",,none,"['Injection site reaction', 'Rash erythematous', 'Rash papular']",1,MODERNA,IM 940423,IL,29.0,F,"Estimated due date: 03/17/2021 On the day of the vaccine during observation I had tingling in my mouth, numbness in tongue and I just used my Benadryl and it eased the symptoms. But at night I started wheezing, had sweats and chills, did not check my temperature but I had pretty severe chills that night. In the morning I checked no fever, but still chills, severe cough and sore throat.. Headache and fatigue. All got worse more severe on Saturday and then I decided to go get tested for Covid on the Care Clinic. I had a known exposure to COVID before I got the vaccine around 01/04/21 - my husband who tested positive on the 6th) I tested positive. All symptoms continued (except the tingling on the mouth it stopped on the 8th) and I saw my OB-GYN on the 11th due to a low amniotic fluid - I had an ultrasound at the facility and was referred to MD and saw him on the 11th as well. Now I lost my sense of taste and smell. The chills have subsided a little bit and so the headache, but fatigue, congestion and cough are still there. I had increased intermittent shortness of breathe but could be the baby's position.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Prenatal vitamins. Allegra, singular, 25mcg centroid","Just my normal allergies symptoms, nasal drainage and cough",Hypothyroid and Allergies,,"sensitivity to doxycycline, seasonal allergies, mango","['Ageusia', 'Amniotic fluid volume decreased', 'Anosmia', 'Chills', 'Cough', 'Dyspnoea', 'Exposure during pregnancy', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Hypoaesthesia oral', 'Oropharyngeal pain', 'Paraesthesia oral', 'SARS-CoV-2 test positive', 'Ultrasound scan', 'Wheezing']",1,PFIZER\BIONTECH,SYR 940438,NE,88.0,F,"Had Covid Vaccine AM of 1.8.2021. Woke up with Nausea, Vomiting X 4, Chills the following AM. Presented to ED. Found to be hypotensive during ER. Nausea Vomiting resolved. Tx with fluid replacement and dismissed home instructed to monitor BP. B/P dropped again at home returned and admitted to hospital.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Oxybutynin Levothyroxine Meloxicam Metoprolol Pantoprazole ASA Tylenol PM Potassium Acetate Calcium Carbonate Glucosamine,Urinary Incontinence (UA negative 12/29/2020),Hearing Loss Hyperlipidemia Hypothyroidism Osteoarthritis Osteopenia Urinary Incontinence,,Naproxen,"['Blood lactic acid increased', 'Chest X-ray abnormal', 'Chills', 'Culture negative', 'Hypotension', 'Lung hyperinflation', 'Nausea', 'Urine leukocyte esterase', 'Vomiting', 'White blood cell count increased']",1,MODERNA,IM 940470,IA,94.0,F,"Site: Pain at Injection Site-Medium, Systemic: Generalized Body Aches -Severe, Systemic: Headache-Severe, Systemic: Severe drop in blood pressure, pulse, and o-sat-Severe",Not Reported,,Not Reported,Yes,,Not Reported,,12/28/2020,12/28/2020,0.0,SEN,,,,,Unknown,"['Blood pressure decreased', 'Headache', 'Heart rate decreased', 'Injection site pain', 'Oxygen saturation decreased', 'Pain']",1,PFIZER\BIONTECH,IM 940510,FL,44.0,F,At 1047 patient reported back to the clinic that she was having difficulty swallowing. Angioedema present. 1048 Patient was given albuterol 2.5mg witth ipratropium 0.5mg nebulizer treatment. At 1049 Benadryl 25mg IM in right deltoid. 1053 BP 134/90 96.4 98% on breathing treatment. 1054 BP 131/90 HR 120. 1100 Benadryl 25mg IM repeated in right deltoid. 1112 137/92 HR 102 POX 100% on Room air. 1116 167/100 HR 104 POX 100% on room air. MD and pharmacist arrived. 1130 Patient given 2 tablets of 4mg (8mg) of Medrol . 1200 BP 128/86 HR 97 POX 98% Remained in clinic until 1230. Rx for medrol dose pack given.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,WRK,"Vitamin C, Vitamin D, Multiivitamin, Probiotic","Asthma, Post-nasal Drip, Seasonal allergies",Asthma,,NKDA,"['Angioedema', 'Dysphagia']",1,MODERNA,IM 940519,IN,33.0,F,"Patient reported symptoms started ~15 mins s/p dose. Symptoms reported LUE and LLE numbness/tingling, and notable tachycardia",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/12/2021,01/12/2021,0.0,PVT,norethindrone 0.35 mg tab,none,none,,NKDA,"['Chest X-ray normal', 'Computerised tomogram head normal', 'Echocardiogram', 'Electrocardiogram normal', 'Hypoaesthesia', 'Laboratory test normal', 'Magnetic resonance imaging brain', 'Paraesthesia', 'Tachycardia', 'Ultrasound Doppler']",1,PFIZER\BIONTECH, 940538,TX,54.0,F,"Headache, chills, pain the bones, irregular temperature (very cold) and pain in the right arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,PUB,,COVID-19,"Diabetes,",,Metamizole,"['Body temperature abnormal', 'Bone pain', 'Chills', 'Feeling cold', 'Headache', 'Pain in extremity']",1,MODERNA,SYR 940582,NJ,60.0,M,disabling pain in left shoulder after the vaccine- progressively worsened over days,Not Reported,,Not Reported,Not Reported,,Yes,N,10/21/2020,10/21/2020,0.0,PVT,"Amlodipine, azelastine, losartan, Rosuvastatin, Viagra",,"diabetes, hypertension, hyperlipidemia, megaloblastic red blood cells, obesity, fatty liver, prostate cancer, gallstones, GERD",,benazepril/quinapril-AE: cough,['Injection site pain'],,PROTEIN SCIENCES CORPORATION,IM 940602,TX,83.0,M,"Patient received vaccine on 1/8/2021. On 1/9/2021 I checked on patient via phone for symptoms or problems and he reported none but mild soreness at injection site. On 1/10/2021 family friend called me to tell me that patient had expired at about 8:00 pm. Patient reportedly complained of ""pain"" unspecific and collapsed at home. Hospital reportedly told family that it appeared to be a ""heart attack"".",Yes,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/10/2021,2.0,PVT,see attached,None reported,"HTN, Type II DM, High cholesterol",,None,"['Death', 'Injection site pain', 'Myocardial infarction', 'Pain', 'Syncope']",5,MODERNA,IM 940651,TN,46.0,M,"I was being monitored for 15 mins since I was allergic to tree nuts stayed 20 mins. I started feeling dizzy and exp nausea lasted 20 sec. After about 12 hrs later I woke up had difficult swallowing felt like something in my throat. I went to ER received a dose pack, Benadryl and steroid injection.",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PUB,"Vit, Prilosec, Zyrtec, Probiotics",No,No,,"Tree buts, Sesame seeds","['Dizziness', 'Dysphagia', 'Nausea', 'Sensation of foreign body']",1,MODERNA,IM 940671,TX,56.0,F,"1/2/21 fatigued, slight headache, achy arm 1/3/21 - 1/6/21 fatigued, slight hedche, reddened area below injection site, itchy at site 1/7/21 - 1/13/21, felt great, except that red area was/is smaller than a baseball with itching. No swelling. * I have been taking Benadryl to help with discomfort, but doesn't seem to help. I have not received any text from VAERS about possible side effects and not sure if I should get 2nd does due to this side effect?",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,PHM,"lo-seasonique, mvl/imitrix prn",none,none,,none,"['Discomfort', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pruritus', 'Pain']",1,MODERNA,IM 940708,NY,79.0,F,"Jan 1st, patient had a seizure after breakfast. Temperature was 98.5 Pulse 95. B.P. 160/70 Two hours later another seizure at the home, with emesis, Sent to hospital at 2pm. Focal Status elepticus. Seizure activity along with continuous persistent activity with emesis throughout the 12 hour time in the ED. Seizure during the CT scan.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,12/30/2020,01/01/2021,2.0,SEN,"Lysinopril, Lipitor, Limictal, tegratol, lexapro, eiquis, careg, prilosec, torsamid, B12, Vit D. Tylenol, lexapro","Epilepsy. High BP,",Epilepsy,,None,"['Computerised tomogram normal', 'SARS-CoV-2 test negative', 'Seizure', 'Status epilepticus', 'Urine analysis abnormal', 'Vomiting']",1,PFIZER\BIONTECH,SC 940713,CA,36.0,F,Following day 1 after vaccine given redness swollen hot to touch on injection site. By day 5 went away by day 8 came back redness bigger than before swelling warm to touch. After vaccine given stopped Imovan got better but came back. Arm keeps tingling will take Benadryl,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,WRK,Imivan 150mg,,Sarcoidosis,,"Amoxcillin, Erythromycin","['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Paraesthesia']",UNK,MODERNA,IM 940773,IN,51.0,F,"Severe pain at site starting by 1800 01/11/2021. 01/12/2021 Severe pain at site kept me awake most the night, headache, nausea, joint pain starting at 0615 01/12/2021 which continued to get worse through out the day. Left work early 01/12/2021. Woke 01/13/2021 with slight headache still.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/12/2021,1.0,UNK,"Wellbutrin, Vit E",acute bronchitis,asthma,,amino amides,"['Arthralgia', 'Headache', 'Injection site pain', 'Nausea']",2,PFIZER\BIONTECH,IM 940784,ND,28.0,F,"Anaphylaxis reaction; A spontaneous report was received from a nurse concerning her co-worker, a 28 year-old female patient, who received Moderna's COVID-19 Vaccine and experienced anaphylaxis reaction. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Dec 2020, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 23 Dec 2020, within five minutes of vaccine administration, the patient experienced anaphylaxis reaction. The patient had symptoms of throat tightness, dizziness, nausea, weakness, and increased heart rate. Treatment for the event included an epinephrine pen On 29 Dec 2020, the nurse reported that the patient was still having some of the symptoms, including dizziness, nausea, and weakness. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, anaphylaxis reaction, was considered not resolved. The reporter assessed the event, anaphylaxis reaction, as related to Moderna's COVID-19 Vaccine.; Reporter's Comments: This case concerns a 28 year old female patient, who experienced a serious unexpected event of anaphylactic reaction. The event occurred apparently 5 min after first dose of mRNA-1273 (Lot# unknown) vaccine administration. She was treated with epinephrine pen. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Anaphylactic reaction', 'Asthenia', 'Dizziness', 'Nausea', 'Throat tightness']",1,MODERNA,OT 940788,TX,83.0,M,"Rash, erthema to injection site, tender",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,PVT,eye drops; olopatadine; Gabapentin; calcium carbonate-vitamin D3; aspirin; amitriptyline; multivitamin/mineral supplement; Vitamin D3; Coenzyme Q10; losartan; Crestor,,,,"Gluten: diarrhea; Penicillins: swelling,hives; Sulfonamides: Rash; Tetracyclines: hives","['Injection site erythema', 'Rash', 'Tenderness']",1,MODERNA,IM 940791,TX,39.0,M,"severe stabbing-shooting lower back pain; severe stabbing-shooting lower back pain that radiated to both legs; Pricking, pins and needles sensations in the hands and feet; numbness; weakness to both legs but mostly the right leg; Coordination problems, unsteadiness; Coordination problems, unsteadiness; This is a spontaneous report from a contactable nurse (patient). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscular on 20Dec2020 08:00 at single dose at left arm for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications in two weeks included multivitamins. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. No known allergies to medications, food, or other products. On 22Dec2020 at approximately 19:15, the patient experienced sudden onset of severe stabbing-shooting lower back pain that radiated to both legs. Pricking, pins and needles sensations in the hands and feet. Coordination problems, unsteadiness, numbness, and weakness to both legs but mostly the right leg. The patient underwent lab tests and procedures post-vaccination which included nasal swab for covid test: negative on 30Dec2020 (Antigen Test). Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Patient received pain medication, steroid dose pack, MRI (pending), and physical therapy (pending) as treatment. Outcome of all events was not recovered.; Sender's Comments: Based on the compatible temporal association, a contributory role of vaccination with BNT162B2 in the onset of the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/20/2020,12/22/2020,2.0,PVT,,,Medical History/Concurrent Conditions: Hypertension,,,"['Back pain', 'Balance disorder', 'Coordination abnormal', 'Hypoaesthesia', 'Muscular weakness', 'Pain', 'Pain in extremity', 'Paraesthesia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,OT 940792,MA,,F,"high blood pressure within 15 min post vaccination. BP 180/94/BP rose to 202/110; This is a spontaneous report from a contactable nurse. An adult female (age:18-64 Years) patient (pregnant: No) received first dose of BNT162B2 (Pfizer), intramuscularly in left arm on 05Jan2021 10:30 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was received other concomitant drugs. The patient experienced high blood pressure within 15 min post vaccination. BP (blood pressure) 180/94 rose to 202/110 on 05Jan2021 10:45. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The events were reported as non-serious. Recipient experienced high blood pressure within 15 min post vaccination. Went to hospital where her pressure was 202/110, vaccine given on 05Jan2021 at 10:30 am, by 10:45 am BP was 180/94, recipient refused hospitalization. Sister took her home but made her go to the hospital where her BP rose to 202/110. IV (intravenous) steroids given. The outcome of event was resolved in Jan2021. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications the patient received within 2 weeks of vaccination: Protein drink. Unknown whether was the patient diagnosed with COVID-19 prior to vaccination. Unknown whether the patient been tested for COVID-19 Since the vaccination. Unknown allergies to medications, food, or other products. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported event hypertension. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,['Hypertension'],1,PFIZER\BIONTECH,OT 940794,VA,,F,"First dose on 16Dec2020, second dose on 05Jan2021; Tinnitus; constant ringing in ears; louder this time; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient (no pregnancy) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), with first dose (lot number: EH9899) on 16Dec2020 via intramuscular route, with second dose (lot number: EK4176) on 05Jan2021 via an unspecified route of administration, both at single dose for covid-19 immunization. Medical history included allergies: penicillin. Concomitant medication included famotidine, ibuprofen (DUEXIS), iron (IRON) and multivitamins, all received within two weeks of vaccination. On 17Dec2020, the patient experienced tinnitus, constant ringing in ears that started 24 hours after first vaccine, lasted about 2-3 days and went away. Ringing in ears started again and is louder this time on 06Jan2021. Facility where the most recent COVID-19 vaccine was administered was in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event was identified as serious and resulted in disability or permanent damage. The outcome of event tinnitus was not recovered. The outcome of the other event was unknown.; Sender's Comments: Based on the compatible temporal association with positive rechallenge result, the Company considers the event tinnitus is possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/05/2021,12/17/2020,,PVT,DUEXIS;,,Medical History/Concurrent Conditions: Penicillin allergy,,,['Tinnitus'],2,PFIZER\BIONTECH, 940798,LA,39.0,F,"Injection site was red and a little swollen the next day and has become increasingly larger. Today (3 days later) the injection site is red, warm, swollen, and about the size of a grapefruit.; Injection site was red and a little swollen the next day and has become increasingly larger. Today (3 days later) the injection site is red, warm, swollen, and about the size of a grapefruit.; Injection site was red and a little swollen the next day and has become increasingly larger. Today (3 days later) the injection site is red, warm, swollen, and about the size of a grapefruit.; This is a spontaneous report from a contactable other HCP. A 39-yearsold female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscular in left arm on 04Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included COVID-19 prior to vaccination. Concomitant medication included desvenlafaxine succinate (PRISTIQ), fluoxetine (FLUOXETINE), bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), etonogestrel (NEXPLANON) , ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), cyanocobalamin (VIT B12), and iron. On 05Jan2021, the patient experienced injection site was red and a little swollen and has become increasingly larger. 3 days later, on 08Jan2021, the injection site was red, warm, swollen, and about the size of a grapefruit. The outcome of the event was not recovered. Treatment included over the counter medications and ice. The patient was not tested for COVID-19 post vaccination.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported injection site reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,PRISTIQ; ; CONTRAVE; ; NEXPLANON; VITAMIN D [ERGOCALCIFEROL]; VIT B12;,,Medical History/Concurrent Conditions: COVID-19 (if covid prior vaccination),,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,PFIZER\BIONTECH,OT 940800,MN,,F,"dizzy; felt like I was going to pass out; shaky; ringing in ears; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via intramuscular route of administration on the left arm on 30Dec2020 17:00 at a single dose for COVID-19 immunization at hospital facility. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks, or any other medications within 2 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported ""almost immediately, dizzy, felt like I was going to pass out, shaky, and ringing in ears"" on 30Dec2020 17:00. Events were reported as non-serious but resulted in visit to the Emergency room/department or urgent care. Ondansetron (ZOFRAN) was given as treatment for nausea and meclizine. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported ""dizzy, felt like I was going to pass out, shaky, and ringing in ears"" and the administration of COVID 19 vaccine, BNT162B2, based on the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dizziness', 'Tinnitus', 'Tremor']",1,PFIZER\BIONTECH,OT 940801,CA,64.0,F,"felt flushed; BP elevated 226/97; dull occipital headache/dull headache; This is a spontaneous report from a contactable other HCP (patient). A 64-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided) via an unspecified route of administration (vaccination location: left arm) on 06Jan2021 09:30 at SINGLE DOSE for COVID-19 immunisation. Medical history was reported as 'none'. It was also reported that patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, and prior to vaccination, the patient was not diagnosed with COVID. The patient has no allergies to medications, food, or other products (no known allergies). The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899; expiration date not provided), via an unspecified route of administration (vaccination location: left arm) on 18Dec2020 18:00 at SINGLE DOSE for COVID-19 immunisation. It was reported that patient received second dose of Pfizer Covid vaccine on 06Jan2021 at 09:30 am. One hour after the 2nd dose (10:30 am), patient experienced dull occipital headache. Patient took paracetamol (TYLENOL). At 10:45 am, patient felt flushed. The nurse took patient's vital signs and noted no fever, normal heart rate and respiratory rate. BP elevated 226/97 (reported at 10:30, no unit provided; normal BP: 130's/80's). At 12:45, patient was taken to ED. CT scan and lab work were reported as all normal. BP continues to be elevated. Amlodipine (NORVASC) 10 mg was given at 17:00. BP slowly came down. Twenty-four hours later, BP was normal at 137/72 (no unit provided). No additional medication taken. It was reported that patient continues to have dull headache. No arm soreness or other symptoms. It was also reported that since the vaccination, the patient has not been tested for COVID-19. Outcome of the events 'BP elevated 226/97' and 'felt flushed' was recovering, outcome of the event 'dull occipital headache/dull headache' was not recovered.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, the Company considers the reported event blood pressure increased is possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Blood pressure increased', 'Computerised tomogram normal', 'Flushing', 'Headache', 'Laboratory test normal']",2,PFIZER\BIONTECH, 940805,PA,27.0,F,"rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over; a lot of muscle pain; could not sleep; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left deltoid on 24Dec2020 09:30 at single dose for preventative. Medical history included none. There were no concomitant medications. The patient previously took influenza vaccine (FLU) for immunization and experienced sick (Flu shot if it contains egg she gets really sick). Patient reported experiencing a rash 2 weeks on 06Jan2021 after getting her first dose of the vaccine. Caller stated ''I'm concerned because I'm getting this rash on my face and everywhere and I'm due for my booster on 13Jan2021."" Caller questioned if others had reported this. She had a lot of muscle pain on 24Dec2020 and could not sleep from the pain in Dec2020. Reports the pain is gone now and lasted till 28Dec2020. She has a rash and it is breaking out her face and now it is all over. States nothing has changed and the vaccine was the only new thing. States the rash started two weeks since she got the vaccine. Vaccination facility type was Hospital. Vaccine administered at military facility was No. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. AE not require a visit to emergency room. Therapeutic measures were taken as a result of rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over (Doctor ordered steroids for her today she is a CNA). The outcome of the event a lot of muscle pain was recovered on 28Dec2020. The outcome of the event rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over was not recovered. The outcome of the event could not sleep was unknown. Information about lot/batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/01/2020,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Myalgia', 'Rash', 'Sleep disorder']",1,PFIZER\BIONTECH,OT 940806,,,F,"passed out; blood pressure was lowered; blood sugar high; weakened; feeling tired and her legs are heavy; feeling tired and her legs are heavy; This is a spontaneous report from a contactable consumer (Patient's Mother). A 23-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 Monday at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced passed out 12 hours post injection (Jan2021). She specified that her daughter was therefore brought to hospital by ambulance. She continued explaining that her blood pressure was lowered, her blood sugar high and that she was weakened (Jan2021). On 08Jan2021, ""day 4"", she said that her daughter had been feeling tired and her legs are heavy (Jan2021). The event outcome was unknown. She then asked if those side effects were experienced after the vaccine. It was not reported as serious. Information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/01/2021,,UNK,,,,,,"['Asthenia', 'Blood glucose increased', 'Fatigue', 'Hypotension', 'Limb discomfort', 'Loss of consciousness']",UNK,PFIZER\BIONTECH, 940809,NY,61.0,M,"left side will blur; Left side of face was sagging/ water leaking out of mouth/Progressive weakness on left side of face/ Swelling on lower left mandible/ diagnosed with Bell's Palsy.; Eye tearing; This is a spontaneous report from a contactable nurse who reported for himself. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EK5780) in left arm on 26Dec2020 at 08:30 at single dose for covid-19 immunisation (worked in surgical ICU and was over 61 years old). Medical history included Pre-diabetic. Family history included: mother died; mother's side had colon cancer and grandparents and uncles had cardiovascular diseases.Concomitant medication included exenatide (BYDUREON), amlodipine besilate (NORVASC), omeprazole (PROTONIX), hydrochlorothiazide, lisinopril and pneumococcal vaccine on 08Dec2020 and tetanus vaccine on 08Dec2020. It was reported that on 31Dec2020 at 07:30, the patient had eye tearing and water leaking out of mouth, left side of face was sagging, swelling on lower left mandible (eye tearing was first, as reported); on 31Dec2020 he also experienced progressive weakness on left side of face; on 02Jan2021 the patient was diagnosed with Bell's Palsy. Then on an unknown date, left side will blur occurred. All events required emergency room visit and physician office visit. Diagnosis of Bell's Palsy and event eye tearing were serious per disability; left side will blur was non serious. Patient described the events as follows: on 31Dec2020 he was brushing teeth and noticed the water was going everywhere. Left side of face was sagging, noticed some swelling and thought it was from a bug bite. He wasn't sure if it was a stroke or not. In the morning of 01Jan2021 noticed it was progressively causing a problem. Days before noticed tearing of left eye (as reported). On 31Dec2020 before midnight, something felt wrong. He saw four cases on clinical trial with similar side effects (he clarified he had no patient information for the four patients mentioned with similar side effects from Pfizer Clinical trial. He saw this information from a article; stated four from Pfizer and Moderna). In the morning of 02Jan202, he went to Emergency Room (ER) and was diagnosed with Bells Palsy. He was given prednisone 20mg to take 3 times by mouth every day for 5 days, tetracycline 100mg, at 1 capsule by mouth twice a day for 10 days and methylprednisolone (SOLU MEDROL; Lot: 9945776;Exp: Nov2021) 4mg dose pack, started with 6 tablets first day. It was told by doctor it might cause tick problems. He was waiting for results. On 04Jan2021 went to family doctor and more blood work was taken. Because he was taking prednisone, noticed his sugar was up a little bit (date unspecified). It was prescribed Glitizide extended release, 2.5mg one tablet twice a day with breakfast. Patient was checking sugar every 6 hours. It was also prescribed Acyclovir 400mg one tablet orally five times per day for 10 days. 08Jan2021 is last day of prednisone 5 day dose and will follow up with methylprednisolone tablets. Patient had an appointment with a neurologist on 13Jan2021. Patient was still having symptoms. It was really hard for him. Not hard to swallow. Face was still drooping. Eyes were still tearing. Could not work with eyes tearing all of the time. Needed to be alert. When driving, had to focus on the right side because his left side will blur. He had to chew only on the right side because food will be left behind in between his cheeks and gums. If he drank through a straw, he had to cover the left side of his lips so he was able to suck out fluids. He thought symptoms were progressively getting worse, he didn't see much improvement. He clarified swelling was on lower part of mandible on left side. It was slightly bigger than right. When looking at face, the lines on his forehead on the left side were down. If he smiled he cannot raise his left eye brow, when before the COVID-19 vaccine he could. Noticed left side of nose was lower than the right. Cannot raise left side of lips. Outcome of the event Eyes tearing and Bell's Palsy was not recovered; outcome of the other event was unknown. Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Bell's palsy, Lacrimation increased and vision blurred due to temporal relationship. However, the Bell's palsy may likely possibly represent concurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and viral serologies, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/26/2020,12/31/2020,5.0,PVT,BYDUREON; NORVASC; PROTONIX [OMEPRAZOLE]; ;,,"Medical History/Concurrent Conditions: Cardiovascular disease, unspecified (Grandparents and uncles); Colon cancer (Mother's side); Death of mother (Mother); Pre-diabetic",,,"['Blood glucose increased', 'Blood test', 'Drooling', 'Facial paralysis', 'Facial paresis', 'Feeling abnormal', 'Impaired work ability', 'Lacrimation increased', 'Swelling face', 'Vision blurred']",UNK,PFIZER\BIONTECH, 940810,,,M,"Bell's Palsy; This is a spontaneous report from a contactable nurse. A 33-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter reported a patient developed Bell's Palsy after receiving the first dose of the vaccine. This patient was a physician, the reporter stated that the patient was scheduled to receive the second dose on Monday (unspecified date) and questioned if he should or should not get the second dose. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Facial paralysis'],1,PFIZER\BIONTECH, 940811,CO,36.0,F,"hearing loss; ringing and pulsating in her ears; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration in in the left arm on 04Jan2021 at single dose for covid-19 immunization. Medical history included ongoing acid reflux. The patient had no concomitant medications. The patient previous received the flu shot. The patient experienced hearing loss, ringing and pulsating in her ears on 05Jan2021, headache on 04Jan2021, chills on 05Jan2021. Treatment was none. She had the vaccine on Monday at work and some of the symptoms that she has had have not resolved. She was having ringing in her ears and hearing loss. Went to see them and had her ears looked at. Everything was normal. Got the vaccine on 04Jan2021. Ringing in ears and hearing loss: Had been very consistent with no improvement. If anything, it had worsened. She was going to re-contact her doctor. She was also going to ask, should she go on Prednisone or something. She was worried she was going to lose her hearing. Her doctor said that a hearing test may need to be done. History: Takes one medication that she has been taking for years. She has never had an adverse event to any vaccine before. She got the flu shot every year. She was expecting the chills and headache, but they resolved fast. The next vaccine was 25Jan2021, the patient was asked whether she should get the second dose. The outcome of events for hearing loss, ringing and pulsating in her ears was not resolved, for headache and chills was resolved on 06Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,UNK,,Acid reflux (esophageal),,,,"['Chills', 'Deafness', 'Headache', 'Tinnitus']",1,PFIZER\BIONTECH, 940813,NJ,100.0,F,"she was dying as her blood pressure dropped to 70/40 and to come for a last visit; This is a spontaneous report from a contactable consumer. A 100-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunization. Medical history included COVID in Dec2020, urinary tract infection (UTI), dehydration and Covid sickness (vomiting) (was treated earlier in month for UTI and dehydration from the Covid sickness (vomiting)). Known allergies: no. The patient's concomitant medications were not reported. After testing positive in mid December to COVID and being declared Covid free on 30Dec by the nursing staff and in good health, with normal vitals and oxygen levels, the patient was given a vaccination on 02Jan2021. In the early evening the patient's blood pressure dropped to 70/40 and the reporter was told to come for a last visit. The patient was sleeping comfortably. She did not wake up when spoke with her. No one expected her to make it through the night. The next morning she work up, ate breakfast, watched TV, got IVs and oxygen and her vitals improved significantly. Lab tests and procedures included blood pressure: 70/40 on 02Jan2021, oxygen levels: normal, COVID test: positive in Dec2020 (testing positive in mid December to COVID and being declare Covid free on 30Dec), vitals: normal; improved significantly. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Since the vaccination, has the patient been tested for COVID-19: No. AE resulted in: Life threatening illness (immediate risk of death from the event). Serious: Yes. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: Yes. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Information about lot/batch number has been requested.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,OTH,,,Medical History/Concurrent Conditions: COVID-19 (If COVID prior vaccination: Yes); Dehydration; UTI; Vomiting,,,"['Blood pressure decreased', 'Unresponsive to stimuli']",UNK,PFIZER\BIONTECH, 940819,KS,21.0,F,"dizzy; itchy throat; coughing; swollen throat; This is a spontaneous report from a contactable pharmacist. A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, NDC number: 59267-1000-1; Expiry Date: Mar2021), via an unspecified route of administration on 07Jan2021 11:20 at 0.3 mL, single at left arm for vaccination. Medical history included Cushing's disease (recovering), bipolar disorder from an unknown date and unknown if ongoing. Concomitant medication included lamotrigine (LAMICTAL) for bipolar disorder. On 07Jan2021, looked like after receiving the vaccine about 30 minutes later patient was standing and felt like dizzy. About 15 or 20 more minutes, or 45-50 minutes after received injection, she felt like itchy throat, then itchy throat triggered coughing, then she felt like swollen throat. For the treatment on scene patient was administered 50mg of diphenhydramine hydrochloride (BENADRYL) and when she complained of swollen throat was administered epinephrine (EPI-PEN) 0.3mg injection to right thigh. Then they called EMS who transported her to the hospital where she was admitted to the hospital. Outcome of events was unknown. This report was considered as serious per caused/prolonged hospitalization. Causality: Cannot jump to that conclusion.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events dizziness, throat irritation, cough and pharyngeal swelling cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/07/2021,01/07/2021,0.0,OTH,LAMICTAL,,Medical History/Concurrent Conditions: Bipolar disorder; Cushing's disease (recovering),,,"['Cough', 'Dizziness', 'Pharyngeal swelling', 'Throat irritation']",UNK,PFIZER\BIONTECH, 940820,ME,63.0,F,"horrible body aches; Nausea; head fogginess; felt like a lump and couldn't move; not wanting to eat; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (Batch/lot number: E10140) first dose on 28Dec2020 11:15AM in the right arm at single dose since she is front line health care worker. Medical history included pain. Medical history included tramadol for pain. No Prior Vaccinations (within 4 weeks). Family Medical History Relevant to AE was none. She received the vaccine 28Dec2020 and it flattened her for two days. Her primary care provided has advised her not to take the next dose. Within 45 minutes she noticed nausea. She was eating lunch and she felt like everything was coming up and she forced herself not to vomit. The she noticed horrible body aches; head was foggy; she felt like a lump and couldn't move;. The body aches hurt in her arms, legs, hips, and back. Adds she was out of work for two days. She could feel it working as the symptoms would peak and then drop. She did go back to work but shouldn't have as she continued to feel nauseous and not wanting to eat. All of these symptoms have now resolved. Vaccination Facility Type was nursing home. No Vaccine Administered at Military Facility. Facility Name: Nursing Home. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Event not resulted in Physician office or ER. The outcome of the event nausea was recovered on 02Jan2021. The outcome of event not wanting to eat recovered on 03Jan2021. The outcome of other events was recovered on 01Jan2021. The seriousness criteria for event horrible body aches was reported as medical significant.; Sender's Comments: The patient had medical history included pain. A possible contribution role of the first dose of BNT162B2 to the horrible body aches cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,OTH,,,Medical History/Concurrent Conditions: Pain,,,"['Arthralgia', 'Back pain', 'Condition aggravated', 'Decreased appetite', 'Feeling abnormal', 'Impaired work ability', 'Mobility decreased', 'Nausea', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 940822,GA,81.0,M,"patient passed away after receiving the Covid vaccine; This is a spontaneous report from a contactable nurse. An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular into the right arm on 07Jan2021 at 0.3 mL, single for covid-19 immunization. There was no medical history and no concomitant medications. On 08Jan2021, the patient passed away after receiving the COVID vaccine. The patient died on 08Jan2021. An autopsy was not performed. Investigations indicate that unspecified labs were done, but nothing two weeks prior; no further details were provided. The patient received the first dose the day prior. The reporting nurse discussed it with the medical director, and he thought that he potentially passed away from the COVID vaccine. The relatedness of the event to the suspect vaccine was reported as related by the reporting nurse per The Agency. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .; Sender's Comments: Based on the limited information available, it is medically not possible to make meaningful causality assessment, it is unlikely the vaccine could have contributed to the death of the patient based on the known safety profile. However case will be reevaluated when additional information is received during the follow-up The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Stated that the patient passed away after receiving the Covid vaccine",Yes,01/08/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Death'],UNK,PFIZER\BIONTECH,OT 940838,NJ,42.0,F,"10 minutes after the shot was given, I suddenly felt my heart was racing and a tingling sensation started from my left arm and radiated to my whole body. The sensation was very intense it felt like my whole body was being paralyzed. I was fading out because of high heart rate. My heart rate was 160 and I heard someone said my blood pressure was high. I was transferred to the ER and given epinephrine, anti-histamine, steroids.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/12/2021,0.0,PVT,"Omega 3, vitamin D",None,None,,Nitroglycerin,"['Heart rate increased', 'Hypertension', 'Paraesthesia', 'Paralysis']",2,PFIZER\BIONTECH,IM 940842,PR,52.0,F,"At the time of the vaccine administration there is a numb tongue, heavy trachea and a numb face. Used medication for asthma. Flovent inhaler for 5 times. Used xyzal 5mgs via oral. These medications are used by doctor's orders.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,OTH,,no,"Asthma, Atopic Dermatitis",,Tequin,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Sensation of foreign body']",1,PFIZER\BIONTECH,IM 940844,ID,31.0,F,"Swelling of wrist, hands and lips. Hives",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/11/2021,0.0,PUB,See Attached Document,,No known allergies,,,"['Joint swelling', 'Lip swelling', 'Peripheral swelling', 'Urticaria']",UNK,MODERNA,IM 940855,AR,79.0,F,Patient received her vaccination on 1/12/21 administered by pharmacy*+. She expired on 1/12/21 an approximately 7:30pm. Resident did not have any adverse reactions and was a hospice patient.,Yes,01/12/2021,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/12/2021,0.0,SEN,LORazepam Solution 2 MG/ML,Resident was a hospice patient but POA requested that she get the vaccination. Resident was already near end of life and the vaccine may not have had anything to do with her death.,Resident on hospice care due to end of life.,,None,['Death'],1,MODERNA,SYR 940866,SC,75.0,M,"Patient was found ""acting abnormal"" on 1/9/2021 at 1215. VS HR 20-30's. EMS activated. EMS arrived and patient was found pulseless in PEA/ asystole, CPR and ACLS initiated and then transported to the MC. Unsuccessful resuscitation and expired on 1/09/2021 at 1348. Clinical impression Cardiopulmonary arrest.",Yes,01/09/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,OTH,"Amlodipine, ASA, Atorvastatin, Baclofen, Risperidone, Levothyr",None,"Hypothyroidism, Bipolar, Profound ID, HTN, Osteopenia, dysphagia, aphasia, TBI as a young adult,Muscle spasm, Hernia",,"Loxapine, Thioridazine","['Abnormal behaviour', 'Cardiac arrest', 'Cardio-respiratory arrest', 'Death', 'Pulse absent', 'Resuscitation']",1,MODERNA,IM 940943,OH,56.0,U,"optic neuritis; loss of vision; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was approximately 56 years old. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 16-NOV-2015, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at a primary care facility for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by healthcare providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: optic neuritis and loss of vision. The outcome of the events was not provided. The reporter considered the events of optic neuritis and blindness to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the events of optic neuritis and blindness were determined to be medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,11/16/2015,,,OTH,,,,,,"['Blindness', 'Optic neuritis']",UNK,MERCK & CO. INC.,OT 940949,WI,21.0,F,"5 days after administration- heavy uterine bleeding; constipation; severe knee/shoulder joint pain; light sensitivity; dizziness/ light headedness; thigh numbness; pain when prodded on either sides of thighs; harsh headache; This is a spontaneous report from a contactable Other healthcare professional (patient). A 21-year-old female patient received BNT162B2 first dose on 31Dec2020 03:15 PM intramuscularly on left arm at single dose for COVID-19 immunization. Medical history included Depression, Anxiety, Factor V Leiden, Known allergies to Penicillin and Onion sensitivity. Patient is not pregnant. No other vaccine in four weeks. Concomitant medications in two weeks included unspecified medications. ""5 days after administration"" (also reported as 01Jan2021)- heavy uterine bleeding (resulting with trip to ER), constipation, severe knee/ shoulder joint pain, light sensitivity, dizziness/ light headedness, thigh numbness, pain when prodded on either sides of thighs, harsh headache. No treatment received for the events. Events resulted in ER and physician office visit. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was not recovered. The seriousness was reported as no. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported uterine bleeding cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,UNK,,,"Medical History/Concurrent Conditions: Anxiety; Depression; Factor V Leiden thrombophilia; Penicillin allergy (Allergies to medications, food, or other products:Penicillin and onion sensitivity); Vegetable allergy (Allergies to medications, food, or other products:Penicillin and onion sensitivity)",,,"['Arthralgia', 'Constipation', 'Dizziness', 'Headache', 'Hypoaesthesia', 'Pain in extremity', 'Photophobia', 'Uterine haemorrhage']",1,PFIZER\BIONTECH,OT 940951,NJ,48.0,F,"Began to start having bulbar reaction with clearing of throat and tightness of chest; Began to start having bulbar reaction with clearing of throat and tightness of chest; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; This is a spontaneous report from a contactable Other-HCP (patient herself). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142), via an unknown route, on 07Jan2021 at 14:15 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 48-year-old. The patient was not pregnant. No other vaccine was received in four weeks.Relevant medical history included COVID 19 complications (prior to vaccination). The patient has allergy to contrast dye, sulfa and molds. Relevant concomitant medications included nebivolol hydrochloride (BYSTOLIC), topiramate (TOPAMAX), atorvastatin (LIPITOR), ascorbic acid, betacarotene, biotin, calcium, chromium, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin d nos, vitamin e nos, xantofyl, zinc (CENTRUM WOMEN), and acetylsalicylic acid (ASA). After vaccination, within 5 min she started with numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation. Began to start having bulbar reaction with clearing of throat and tightness of chest. She was given diphenhydramine hydrochloride (BENADRYL) total 50 mg, famotidine (PEPCID) 20 mg, dexamethasone (DECADRON) 4 mg and racemic epinephrine. The events required visit at emergency room/department and urgent care. However, the events were reported as non-serious by the reporter. Post-vaccination COVID test was not performed. The patient had not recovered from the events.; Sender's Comments: The reported ""numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation"", ""bulbar reaction with clearing of throat and tightness of chest"" developed within 5 min administration of BNT162B2, is likely an allergic reaction to BNT162B2, and considered related. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,BYSTOLIC; TOPAMAX; LIPITOR [ATORVASTATIN]; ASA; CENTRUM WOMEN,,Medical History/Concurrent Conditions: Allergy to molds; Asymptomatic COVID-19 (prior to vaccination); Contrast media allergy; Sulfonamide allergy,,,"['Chest discomfort', 'Hypoaesthesia oral', 'Lip swelling', 'Swollen tongue', 'Throat clearing']",UNK,PFIZER\BIONTECH, 940952,MD,50.0,F,"My b/p shot up as well 180/107; My heart started racing....noted at 133/I had strong heart palpitations; Feeling of lightheadedness; This is a spontaneous report from a contactable nurse reporting for herself. A 50-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration in the right arm on 29Dec2020 at 12:15 pm, at 50-years of age, at single dose for COVID-19 immunization. The patient received the vaccine in Hospital and didn't receive any other vaccine in the previous four weeks. Medical history included hypertension from an unknown date (controlled) and no known allergy. Concomitant medication included amlodipine besilate 10 mg (NORVASC). The patient reported that, on 29Dec2020, within 6 minutes after receiving the vaccine dose, her heart started racing, it was noted at 133, her blood pressure shot up as well to 180/107, she had strong heart palpitations with feeling of lightheadedness. Prior to the vaccine the patient was at work, feeling well and taking care of her patients. Emergency Room visit and Physician Office visit were required, moreover fluids and potassium were administered to the patient as a result of the events. She reported she spent 8 hours in the ER. The events were reported as non-serious but they were assessed as important medical events by the Company. At the time of the report the reported events were resolving. Information about Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hypertensive crisis, Palpitations, and Lightheadedness cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,NORVASC,,Medical History/Concurrent Conditions: Blood pressure high (Controlled),,,"['Blood pressure increased', 'Dizziness', 'Palpitations']",1,PFIZER\BIONTECH, 940955,NY,66.0,F,"Cardiac Arrest; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; This is a spontaneous report from a contactable other healthcare professional (HCP). A 66-year-old female patient (pregnant at the time of vaccination: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via intramuscular at left arm on 11Jan2021 12:15 PM at single dose for COVID-19 immunization. Medical history included diastolic CHF, spinal stenosis, morbid obesity, epilepsy, pulmonary hypertension and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient received medication within 2 weeks of vaccination included amiodarone, melatonin, venlafaxine hydrochloride (EFFEXOR), ibuprofen, aripiprazole (ABILIFY), lisinopril, cranberry capsules, diltiazem, paracetamol (TYLENOL), famotidine, furosemide (LASIX [FUROSEMIDE]), ipratropium bromide, salbutamol sulfate (IPRATROPIUM/ALBUTEROL), buspirone, senna alexandrina leaf (SENNA [SENNA ALEXANDRINA LEAF]), polyethylene glycol 3350 and morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took Penicillin, propranolol, quetiapine, topiramate, Lamictal and had allergy to them. Patient used took the first dose of BNT162B2 (lot number: EJ1685) via intramuscular at right arm on 21Dec2020 12:00 PM at single dose for COVID-19 immunization. Since the vaccination, the patient been tested for COVID-19 (Sars-cov-2 PCR) via nasal swab on 06Jan2021, covid test result was negative. Patient was found pulseless and breathless 20 minutes following the vaccine administration (11Jan2021 12:30 AM). MD found no signs of anaphylaxis. Patient died on 11Jan2021 12:30 AM because of cardiac arrest. No treatment received for the events. Outcome of pulseless and breathless was unknown. the autopsy was performed, and autopsy remarks was unknown. Autopsy-determined cause of death was unknown. It was reported as non-serious, not results in death, Life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.; Sender's Comments: Based on the available information this patient had multiple underlying medical conditions including morbid obesity, diastolic CHF, epilepsy, pulmonary hypertension and COVID-19 diagnosed prior to vaccination. All these conditions more likely contributed to patients cardiac arrest resulting in death. However, based on a close temporal association (""Patient was found pulseless and breathless 20 minutes following the second dose of BNT162B2 vaccine administration, contributory role of BNT162B2 vaccine to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: autopsy remarks was unknown. Autopsy-determined cause of death was unknown",Yes,01/11/2021,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,OTH,; ; EFFEXOR; ; ABILIFY; ; CRANBERRY; ; TYLENOL; ; LASIX [FUROSEMIDE]; IPRATROPIUM/ALBUTEROL; ; SENNA [SENNA ALEXANDRINA LEAF]; POLYETHYLENE GLYCOL 3350;,,"Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19); Diastolic heart failure; Epilepsy; Morbid obesity; Pulmonary hypertension; Spinal stenosis",,,"['Autopsy', 'Cardiac arrest', 'Death', 'Pulse absent', 'Respiratory arrest', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,OT 940956,,,F,"Patient admitted for a fib; This is a spontaneous report from a contactable consumer. A female patient in her 70s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number was unknown, via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received vaccine on Tuesday, 05Jan2021. On Thursday, 07Jan2021, patient did not feel good-pulse and blood pressure. It was mentioned that the patient admitted for a fib. Two days after receiving Pfizer-BioNTech Covid 19 vaccine, the woman patient in her 70s was admitted for a fib. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/05/2021,01/07/2021,2.0,UNK,,,,,,"['Atrial fibrillation', 'Feeling abnormal']",UNK,PFIZER\BIONTECH, 940957,AZ,,F,"anaphylactic reaction; cyst develop on her arm from the pneumonia vaccine; This is a spontaneous report from a contactable healthcare professional (patient herself). A female patient of an unspecified age (reported patient age: 68, unit unspecified) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date in 2011 (reported as '10 years ago') at a single dose for immunization. Medical history included being allergic to tomato, potato, eggplant, cayenne, chili pepper, paprika, whole wheat, and egg albumin; multiple sclerosis, and being immunocompromised (taking immunosuppressants). The patient's concomitant medications were not reported. The patient previously took aluminum, diphenhydramine (BENADRYL), albendazole (BENZOL), and clindamycin and was allergic. She also took interferon beta-1a (AVONEX). The patient reported that she received a pneumonia vaccine, 10 years ago, in which she had an anaphylactic reaction to that resulted in self medicating with an antihistamine. She stated that she had a cyst develop on her arm from the pneumonia vaccine that had to be surgically removed. She also stated that she cannot take the normal flu vaccine. The outcome of events was unknown. Information regarding the batch/lot number has been requested.; Sender's Comments: Based on the implied time association, the possible contribution of suspect pneumococcal 13-valent conjugate vaccine injection to the events anaphylactic reaction and vaccination site cyst cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Food allergy; Immunocompromised (taking immunosuppressants); Multiple sclerosis,,,"['Anaphylactic reaction', 'Cyst removal', 'Vaccination site cyst']",UNK,UNKNOWN MANUFACTURER, 940964,IL,42.0,F,"1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 hours. After 2nd injection on 1/10/21, I had soreness at R arm, fatigue on first day. 2 days after 2nd injection, I developed rash/swelling around both eyes, and on 3rd day had worse eye symptoms and rash across upper chest. I called employee health and my PCP to report symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/12/2021,2.0,PVT,"vit D, vit B, vit C, juice plus",none,,,sulfa antibiotics,"['Eye swelling', 'Fatigue', 'Pain in extremity', 'Rash']",2,PFIZER\BIONTECH,IM 940990,WA,45.0,F,"Vaccine administered at 08:16--08:25 patient c/o feeling unwell and dizzy 87, 143/84, 18, 100%; 08:28: Pt c/o dizzy & chest tightness, appeared pale, monitoring; 08:34: Pt c/o increased chest tightness 130, 144/81, 22, 100% monitoring 08:36: Epinephrine .3mg given IM to R thigh, pt. reported flushing, pounding heart, 911 called; 08:40: Pt flushed.",Not Reported,,Not Reported,Yes,,Not Reported,,12/31/2020,12/31/2020,0.0,PVT,,,,,"Amoxicillin, Bee Stings","['Chest discomfort', 'Dizziness', 'Flushing', 'Malaise', 'Pallor', 'Palpitations']",UNK,PFIZER\BIONTECH,IM 941011,PR,34.0,F,"Presented itchy in the neck area, torso and arms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,OTH,No,No,No,,"Sulfa, penicillin",['Pruritus'],1,PFIZER\BIONTECH,IM 941080,FL,66.0,M,"5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED",Not Reported,,Not Reported,Not Reported,,Yes,U,12/28/2020,01/02/2021,5.0,PVT,None,None,None,,None,"['Abdominal pain upper', 'Antiphospholipid antibodies negative', 'Antithrombin III', 'Arteriosclerosis', 'Beta-2 glycoprotein antibody negative', 'Cardiolipin antibody negative', 'Coagulation time', 'Computerised tomogram abdomen abnormal', 'Diarrhoea', 'Full blood count normal', 'Lipase normal', 'Localised oedema', 'Metabolic function test normal', 'Protein C', 'Protein S normal', 'Red blood cell sedimentation rate normal', 'Renal cyst', 'SARS-CoV-2 test negative', 'Scan with contrast abnormal', 'Thrombosis']",1,MODERNA,IM 941118,LA,52.0,M,At first I has some injection site pain and soreness nothing too bad. But around 01:30 I awoke with a really high fever. My fever was 102.8 when I first woke up. I was very nauseous and my fever felt worse. My thermometer would not read any more until my temp came down. I can only guess how high it got but at least 103 degrees. I took Advil Liquid Gells and then my fever broke. I was actually scare for my life. In March I actually caught coronavirus and developed anti bodies for Covid. I can only guess my body was fighting for it's life.,Not Reported,,Yes,Not Reported,,Not Reported,Y,01/12/2021,01/13/2021,1.0,OTH,"Lisinopril, Plavix, Wellbutrin, Eliquis, Atorvastatin, and Vitamin D 50,000 every 2 weeks",Hypertension,High Blood Psi.,,No allergies.,"['Fear', 'Injection site pain', 'Nausea', 'Pyrexia', 'Sleep disorder']",1,PFIZER\BIONTECH,SYR 941126,,57.0,F,"Patient refers to have presented redness in the administration area, administration area warm to the touch and pain in the arm of the vaccine administration. Refers to after visiting the emergency room have cellulitis.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/31/2020,1.0,WRK,,,,,,"['Cellulitis', 'Injection site erythema', 'Injection site pain', 'Injection site warmth']",UNK,MODERNA,IM 941201,NV,41.0,F,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; A 48-years-old non-pregnant female patient, receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 18Dec2020 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a pharmacy/drug store. Medical history was not reported. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). The patient had not received any other vaccines within four weeks prior to the vaccination nor received any other medications withing 2 weeks prior. It was reported that the patient had been tested for COVID-19 prior to vaccination and was negative. On 18Dec2020, the patient experienced itchy sore eyes one hour after vaccination, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after. The patient was not hospitalized nor received treatment for the events. The clinical outcome of the events of Itchy, sore eyes 1 hour after, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after, was not recovered., the outcome of the COVID-19 positive was unknown. It was reported that the patient tested positive for COVID-19 via nasal swab, post vaccination on 31Dec2020. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PHM,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No, Comment: Other Medical History: No",,,"['Eye pain', 'Eye pruritus', 'Fatigue', 'Headache', 'Oropharyngeal pain', 'Pain in extremity', 'Pharyngeal swelling', 'Pruritus', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 941204,,,F,tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer. A 7-decade-old female patient (in her 60s) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. A pharmacy student received this drug information question in which a female patient in her 60s received the first Covid vaccine on 23Dec2020 and tested positive for Covid on 04Jan2021. Could the patient receive antibody treatment? Could she get the second vaccine and when? The outcome of the events was unknown. Information about Lot/Batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/04/2021,12.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 941205,CA,32.0,M,"Caller is a respiratory therapist who reports that he tested positive for covid after receiving the first dose of the vaccine on 17Dec; Caller is a respiratory therapist who reports that he tested positive for covid after receiving the first dose of the vaccine on 17Dec; This is a spontaneous report from a contactable consumer (patient) reported that a 32-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration from on 17Dec2020 at single dose (once by injection in the right arm/bicep) for COVID-19 immunization (Healthcare worker). There were no medical history and concomitant medications reported. The patient/caller is a respiratory therapist who reported that he tested positive for covid after receiving the first dose of the vaccine on 17Dec2020. He called to ask if he can get the second dose. He also wanted to ask if people experienced side effects or what side effects people experience after the second dose. He tested positive for Covid-19 on 21Dec2020, after receiving the first dose of the vaccine. He said it had been 14 days since he tested positive for COVID and he is if he can get the second dose. He says he is actually on his way to get the second dose right now, and thought he should call. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/21/2020,4.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 941212,MA,22.0,F,"hypertension like 190/90; I had tachycardia to 165; Flushing; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK9231, intramuscular on 06Jan2021 at single dose for COVID-19 immunization. Medical history included migraine. Concomitant medication included cyproheptadine for migraine, unspecified multivitamins; and diphenhydramine (BENADRYL) and famotidine as pre-medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Dec2020 for COVID-19 immunization, and experienced dizziness, palpitations, tingling in face and legs, myalgia, nausea, headache, fatigue. It was reported that patient got the second dose and had tachycardia to 165 and hypertension like 190/90 and had some flushing (event onset: 06Jan2021). Patient was no longer tachycardiac or hypertensive; lasted for about 30-40 minutes. Outcome of the events tachycardia and hypertension was recovered on 06Jan2021. Outcome of the event flushing was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,UNK,; BENADRYL;,,Medical History/Concurrent Conditions: Migraine,,,"['Flushing', 'Hypertension', 'Tachycardia']",2,PFIZER\BIONTECH,OT 941215,,90.0,F,"Actual event and cause of death were unknown; This is a spontaneous report from a non-contactable consumer. A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID Prevention. The relevant medical history included aortic valve replacement from Nov2019. Concomitant medications were not reported. The consumer stated that she was taking the reporting responsibilities to report that a friend of hers, informed that the patient passed away on Friday, and had received the COVID vaccine on Wednesday. The consumer stated that it was unknown to her at this time, if the friend had called to complete a report herself, regarding the incident. Their conversation was very brief. The patient was 90 years old, and it was her friend's mother that was the patient. Actual event and cause of death were unknown. The patient had her vaccine on Wednesday 06Jan2021, and then the patient collapsed in front of the reporter at Friday night on 08Jan2021 and passed away that same day. The autopsy was unknown. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Actual event and cause of death were unknown",Yes,01/08/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,UNK,,,Medical History/Concurrent Conditions: Aortic valve replacement (Verbatim: Aortic valve replacement),,,"['Death', 'Syncope']",1,PFIZER\BIONTECH, 941216,,,F,"episodes of severe dyspnea and lightheadedness over the past couple of weeks; episodes of severe dyspnea and lightheadedness over the past couple of weeks; ventricular tachycardia with a rate of 270; severe right ventricular dilatation and dysfunction with inflammation and fibrosis throughout the RV and septum, but minimal LV involvement.; severe right ventricular dilatation and dysfunction with inflammation and fibrosis throughout the RV and septum, but minimal LV involvement.; severe right ventricular dilatation and dysfunction with inflammation and fibrosis throughout the RV and septum, but minimal LV involvement.; This is a spontaneous report from a contactable physician (patient). A 4-decade-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient reported that on 18Dec2020, she received the first dose of Pfizer / BioNTech vaccine. On 30Dec2020 (Wednesday), she was diagnosed of ventricular tachycardia with a rate of 270, severe right ventricular dilatation and dysfunction with inflammation and fibrosis throughout the RV and septum, but minimal LV involvement. On 30Dec2020, EKG showing RBBB with PR 234 (in presence of normal EKG and ECHO from Dec2016), and positive troponin 0.07 that has remained stable in the following week. On unspecified date in Jan2021, the patient had been having episodes of severe dyspnea and lightheadedness over the past couple of weeks, but it had been sporadic - it became significantly worse in the last 2 weeks, which is why patient sought out an electrophysiologist (and purchased at-home EKG monitor on which she saw the VT). Patient do not know the cause at all. She was tested for SARS-CoV-2 antibody yesterday (unspecified date in Jan2021), which was negative. Patient was also trying to determine if she should get the second dose or not. She will have cardiac PET scan next week, which hopefully further elucidate causes. Outcome of the events dyspnea and lightheadedness was not recovered; while outcome of other events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the available information, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/30/2020,12.0,UNK,,,,,,"['Bundle branch block right', 'Dizziness', 'Dyspnoea', 'Echocardiogram normal', 'Electrocardiogram abnormal', 'Fibrosis', 'Inflammation', 'Right ventricular dilatation', 'Right ventricular dysfunction', 'SARS-CoV-2 antibody test negative', 'Troponin', 'Ventricular tachycardia']",1,PFIZER\BIONTECH, 941217,,,U,"My right leg from the knee down was purple and they thought I have a blood clot; My right leg from the knee down was purple and they thought I have a blood clot; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Three days after vaccination the patient felt very sick and he/she was so bad that he/she thought he/she might die with outcome of recovered after one week. The patient reported also that on unknown date his/her right leg from the knee down was purple and they thought he/she have a blood clot, due to which the patient was hospitalized for 14 days. The patient ended in the hospital because his/her right leg from the knee down was purple and they thought he/she have a blood clot but they did an ultrasound that was not the case but they put he/she on antibiotic. The patient was still taking them but his/her leg has got better. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Yes,14.0,Not Reported,N,,,,UNK,,,,,,"['Malaise', 'Skin discolouration', 'Ultrasound scan normal']",UNK,PFIZER\BIONTECH, 941238,PR,35.0,M,"At 5 min after the administration, the rash started on the whole hand where the vaccine was administered, petechiae and his right hand fingers began to swell, then eyes started swelling, back with rash, had vomits. On the second had swelling of the face and dark color on the orbit of the eyes and red and yellow lacerations on the inside of the eye. In addition a lot of pain in the joints without being able to walk.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,WRK,Metformin,,Diabetic,,,"['Arthralgia', 'Dark circles under eyes', 'Eye swelling', 'Gait disturbance', 'Open globe injury', 'Peripheral swelling', 'Petechiae', 'Rash', 'Swelling face', 'Vomiting']",1,PFIZER\BIONTECH,IM 941246,TX,68.0,M,Covid symptoms began 2-3 days after shot. Presented to ER day 11 day after positive with extreme dyspnea O2 Sat at 88% Chest xray opacities throughout the bilateral hemithoracies would suggest multifocal infiltrate Admitted on high flow oxygen reduced to 6 liters currently D-dimer is >35.20,Not Reported,,Not Reported,Yes,,Not Reported,N,12/24/2020,12/27/2020,3.0,PVT,,,DM2,,,"['COVID-19', 'Chest X-ray abnormal', 'Dyspnoea', 'Fibrin D dimer normal', 'Lung infiltration', 'Lung opacity']",UNK,MODERNA,IM 941361,MA,59.0,F,"Went to bed not feeling well. My husband came to check on me approx. 12:30 am. He was unable to arouse me. When he tried to get me up out of bed I collapsed and then had syncopal episode. He call 911. Paramedics could not get blood pressure and I was diaphoretic and body temp was cold. They rushed me to the hospital. My blood pressure was dangerously low along with my body temperature. I was given epinephrine and LEVOPHED to get a blood pressure. I was warmed up. Then I had GI issues of vomiting, diarrhea, nausea. I spend 4 days in hospital.",Not Reported,,Yes,Yes,4.0,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,"Labetalol,Buspirone,Rosuvastatin,Levothyroxine,Lisinopril,Bupropion, Gabapentin, Rabeprazole, Probiotic, Vitamin D, Cevimeline, Scopolamine",,,,,"['Blood pressure decreased', 'Blood pressure immeasurable', 'Body temperature decreased', 'Computerised tomogram', 'Depressed level of consciousness', 'Diarrhoea', 'Full blood count', 'Hyperhidrosis', 'Malaise', 'Metabolic function test', 'Nausea', 'Syncope', 'Vomiting']",1,PFIZER\BIONTECH,IM 941401,CA,99.0,F,"Patient is a 99yr old female who got a covid vaccine in the afternoon of 1/10/21 and woke up in the morning of 1/11/21 with altered mental status, weakness, and dysarthria. She was taken from her assisted living facility to the hospital and MRI showed a small stroke in the right medial thalamus. She was also found to have new onset atrial fibrillation. She was treated appropriately for both conditions and discharged to a skilled nursing facility on 1/13/21.",Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/10/2021,01/11/2021,1.0,SEN,Levothyroxine,None,"hypothyroidism, secondary hyperparathyroidism, chronic kidney disease stage 3",,None,"['Asthenia', 'Atrial fibrillation', 'Dysarthria', 'Electrocardiogram abnormal', 'Magnetic resonance imaging brain abnormal', 'Mental status changes', 'Thalamic infarction']",1,PFIZER\BIONTECH,IM 941408,WA,81.0,F,"Pt was accompanied by daughter, who drove pt to clinic. Pt was correctly identified, screened, given vaccine, monitored for appropriate time. Pt left clinic as passenger of vehicle and was being driven by daughter. Pt started complainingg of Shortness of breath and not feeling right.. Daughter brought pt to local emergency room, Pt was later transferred to higher care hospital. Information regarding symptoms and further medical care was relayed to clinic by family member.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/11/2021,01/11/2021,0.0,PVT,,,"COPD, CHF, HTN, hyperlipidemia",,,"['Dyspnoea', 'Feeling abnormal']",1,MODERNA,IM 941476,FL,45.0,M,Patient received vaccine in afternoon of 12/28. She works in ER as housekeeper 7pm-7am. The day she received the vaccine she became ill with fever chills and nausea and left work at 2am. On 12/31 she developed hemianopia. She went to ER and they did CT scan. She was told it was complex migraine. She left and came Home. On 1/1/21 her vision was back to normal. On 1/3 she suffered bilateral cerebellum ischemic stroke. She is currently in medical center. In Trauma.,Not Reported,,Yes,Yes,6.0,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,Valacyclovir 1gm daily Spirinolactone 100mg TID Januva 100mg 1 daily Glimepiride 2mg BID Elmiron 100mg TID Lisinopril 20mg once daily Escitalopram 10mg once daily,,Diabetes Morbid obesity Hypertension Herpes,,None,"['Angiogram', 'Chills', 'Computerised tomogram', 'Hemianopia', 'Intensive care', 'Ischaemic stroke', 'Magnetic resonance imaging', 'Malaise', 'Migraine', 'Nausea', 'Pyrexia']",1,MODERNA,IM 941499,CA,36.0,F,"Patient experienced a syncopal episode post vaccination, accompanied by feeling hot and tachycardic. Prior to the syncope, she reported hyperventilating. She remained unresponsive for about 10 minutes and was brought to the ED. There she became responsive, and reported chest pain and had sinus tachycardia episodes. She also had lower extremity weakness. This has improved per the latest neurology notes. She also had a negative EEG. Unsure if this is an allergic reaction or if the syncope was due to hyperventilation. Patient is currently on day 3 of hospitalization.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/11/2021,01/11/2021,0.0,WRK,,,,,None,"['Chest pain', 'Electroencephalogram normal', 'Feeling hot', 'Hyperventilation', 'Muscular weakness', 'Sinus tachycardia', 'Syncope', 'Tachycardia', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 941503,SC,90.0,F,"Systemic: Headache, Systemic: Eyes dilated and difficulty remembering information; symptoms lasted 2 days",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/04/2021,01/05/2021,1.0,SEN,,,,,"Shellfish derived products, Codeine, Iodine, Darvon, Tylenol, Sulfa, Darvocet","['Headache', 'Memory impairment', 'Mydriasis']",1,MODERNA,IM 941522,VT,50.0,F,I was short of breath and went to emergency room on 1/5/2021. I was diagnosed with bilateral pulmonary embolisms. I was Covid negative and had no other symptoms.,Not Reported,,Yes,Not Reported,,Not Reported,N,12/01/2020,01/04/2021,34.0,PVT,None,None,None,,None,"['Chest X-ray abnormal', 'Computerised tomogram thorax abnormal', 'Dyspnoea', 'Fibrin D dimer increased', 'Pulmonary embolism', 'SARS-CoV-2 test negative']",1,MODERNA,IM 941553,OH,40.0,F,"2 Hours after the injection, my arm hurt so bad I could not raise it laterally. This continued for 3 days. After that I felt tired and achy until Jan 4th, I had chills and whole body aches. I came home from work, took the next day off. Feeling better, I worked 3 more days and developed the worst headache of my life. I consulted my PCP and went to the emergency room. I was diagnosed with viral meningitis and admitted to the hospital for 3 days. .",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,Cytomel 125 MCG/day Senna Prn Singulair 10 mg pohs Arnuity 100 mcg inhlaer qd,None,"Hypothyroid, environmental allergies",,Environmental,"['Activated partial thromboplastin time normal', 'Chills', 'Computerised tomogram head normal', 'Culture urine negative', 'Fatigue', 'HIV test negative', 'Headache', 'Human chorionic gonadotropin negative', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Lumbar puncture abnormal', 'Meningitis viral', 'Mobility decreased', 'Multipathogen PCR test', 'Pain', 'Pain in extremity', 'Prothrombin time normal', 'SARS-CoV-2 test negative', 'Scan with contrast normal', 'Urine analysis normal']",1,MODERNA,IM 941561,MN,91.0,M,"Staff walked into resident's room around 10:00am and noted resident's left side of his face was flaccid. Nurse was called and upon assessment resident noted to have an unequal hand grasp with left worse. He was able to talk but was mumbled and hard to understand. Physician, hospice, and family were notified. Resident had a stroke at 10:06 am on 1/8/2020. He lost all ability to use his left side. Resident passed away on 1/11/2020.",Yes,01/11/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,SEN,"Escitalopram Oxalate, Metformin ER, Systane balance, Colace, Refresh tears, Milk of Magnesia, Diltiazem",Resident was on hospice for Alzheimer's disease.,"Alzheimer's Disease, Type II diabetes, Major depression disorder, Elevated B/P readings with Hypertension, history of stroke (7/22/2019 - Acute Lacunar Stroke)",,No known Allergies,"['Cerebrovascular accident', 'Death', 'Decreased appetite', 'Grip strength decreased', 'Hemiplegia', 'Hypotonia', 'Speech disorder', 'Weight decreased']",UNK,MODERNA,IM 941563,TX,43.0,F,"Patient received COVID-19 Vaccine at 0956 and reported symptoms of itchy face and chest pressure at approximately 1008 during observation period. Pt vital signs were 133/86, HR 130 and oxygen saturation 100% on room air. Pt reported worsening symptoms of chest pressure and itchiness to face. Provider instructed Epi Pen be given and pt to be transported to ED for further evaluation. EKG obtained and showed sinus tachycardia. Nonrebreather oxygen mask applied with 2L/min and oxygen saturation remained at 100%. Pt was transported via ambulance to at 1038 and pt reported feeling improved symptoms prior to leaving the clinic at approximately 1034. Pt stable at time of transfer.",Not Reported,,Yes,Not Reported,,Not Reported,U,01/13/2021,01/13/2021,0.0,MIL,"Topamax, Amitriptyline, Odansetron, Losartan, Bisacodyl,advair, EpiPen, Prednisone, Ubrogepant, Galcanezbumab injection monthly, benadryl",None,"Iron deficiency anemia, allergic rhinitis, migraines, HTN, BPPV,Asthma",,"Egg, Gadolinium, Iodine, Penicillin G","['Chest discomfort', 'Electrocardiogram abnormal', 'Pruritus', 'Sinus tachycardia']",1,MODERNA,IM 941576,KY,23.0,F,Employee was awaken at 5:30 am on 1/13/2021 by chills and a feverish feeling. She then became nauseous and faint. She passed out and was noted by her mother who is a RN to have a seizure. She remained out for several minutes and then aroused. She has remained groggy the rest of today but has improved. She has a history of non-epileptic seizures since she was 14 and has been on medications for this. Employee stated she has not has any seizure activity in over a year. She did not see medical attention due to recovering quickly from this.,Not Reported,,Yes,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,SEN,Employee is currently taking anti seizure medications,None,non-epileptic seizure disorder,,None known,"['Chills', 'Condition aggravated', 'Loss of consciousness', 'Nausea', 'Pyrexia', 'Seizure', 'Somnolence', 'Syncope']",2,PFIZER\BIONTECH,IM 941607,IN,83.0,F,"The patient passed away today, 1/13/2021. She was a hospice patient. She showed no adverse effects after receiving the vaccine on 1/12/2021. This morning she woke up as normal and during her morning shower she had a bowel movement, went limp and was non-responsive. The patient passed away at 7:45 am.",Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,SEN,"Tylenol 325mg, Lasix 20mg, Senna 8.6mg, Aspirin 81mg, Levothyroxine 75mcg",,"End stage dementia, cerebro vascular disease, Hx left vertebral artery aneurysm",,NKA,"['Anal incontinence', 'Death', 'Hypotonia', 'Unresponsive to stimuli']",1,MODERNA,IM 941633,NC,75.0,M,"The morning following COVID-19 vaccination, patient's right shoulder had swelling, generalized weakness and myalgia. Hospitalized for 2 days, received intravenous fluids and bedrest, and acetaminophen. He was prostrate for 2 days.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/08/2021,01/09/2021,1.0,PUB,,,hypertension spinal stenosis,,none known,"['Asthenia', 'Injection site swelling', 'Myalgia']",1,MODERNA,IM 941641,FL,44.0,F,"numbness to forearm then to lower leg that then took on a dermatomal pattern, brain fog w word finding issues that progressively worsened, LLE weakness. ct brain neg. MRI/MRA head and neck neg. labs neg. MRI of c spine t spine l spine s spine neg. emg and eeg neg. discharged from hospital. symptoms fluctuating. slowly improving.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/01/2020,01/02/2021,32.0,PVT,,,,,,"['Angiogram cerebral normal', 'Aphasia', 'Arteriogram carotid normal', 'Computerised tomogram head normal', 'Electroencephalogram normal', 'Electromyogram normal', 'Feeling abnormal', 'Hypoaesthesia', 'Laboratory test normal', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging neck', 'Magnetic resonance imaging spinal normal', 'Muscular weakness']",1,PFIZER\BIONTECH,IM 941703,IL,36.0,F,"Around 12:00 I started having trouble blinking my right eye and had numbness and tingling around lower orbit. This lasted about 5 hours intermittently. I do have a history of bells palsy and my face never returned back to normal. (first started 2015 with my first pregnancy). I am currently pregnant. This is my third pregnancy, due date 05/03/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,"cetirizine 10 mg daily, vitamin D 5000 units daily, prenatal gummy vitamin",none,"Asthma, Goiter",,"Sulfa (rash), Trileptal (rash), latex (rash)","['Exposure during pregnancy', 'Eye movement disorder', 'Hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 941710,WA,36.0,F,"Swelling started within 2 hours at injection site, height of approximately 2cm, diameter approximately 7cm. Swelling at injection site continued for 2 1/2 weeks. Woke up at approximately 11PM disoriented, tightness of chest, difficulty taking full breath, extreme lightheadness upon standing, that got worse during standing. Temporarily grayed out, fell to knees. Got to sitting position and administered inhaler, took allergy medications. After 15 minutes, symptoms started to abate to point felt comfortable walking. Went to ER. Upon arrival at ER pulse was at 144 and Oxygen Saturation was around 97%. Normal EKG, High WBC at time at 18.7 K/uL, Abs neuts at 15.5K/uL, up from 5.8K/uL reading done on 2/21/2019, Abs immature grans at .1, and Abs monos at 1.3 K/uL. Decadron administered, at 207 am on 3/22/2019. Normal CMP except slightly heightened glucose at 117 mg/dL performed at hospital on 3/22/2019. Continued to have episodes of tachycardia occur, no known trigger, worse during peak allergy season. Continued episodes of tightness in the chest.",Not Reported,,Not Reported,Not Reported,,Yes,U,03/20/2019,03/21/2019,1.0,PVT,"Zyrtec, Aciphex, Flonase, Ursodiol, Astelin, Albuterol(as needed for asthma symptoms)",Bronchitis,"Mild asthma, hay fever, acid reflux at time of vaccine reaction, developed Postural Orthostatic Tachycardia Syndrome and asthma has worsened since reaction.",,,"['Blood glucose normal', 'Brain natriuretic peptide', 'Chest X-ray', 'Chest discomfort', 'Depressed level of consciousness', 'Disorientation', 'Dizziness', 'Dyspnoea', 'Electrocardiogram normal', 'Fall', 'Fibrin D dimer', 'Full blood count', 'Immature granulocyte count increased', 'Injection site swelling', 'Metabolic function test', 'Monocyte count increased', 'Neutrophil count increased', 'Tachycardia', 'Troponin', 'White blood cell count increased']",1,MERCK & CO. INC.,SYR 941740,OK,66.0,F,"Presented to MD'S office on 01/05/2021 with cough, HA, fever 101.9, chills, and fatigue. Returned on 01/07/2021 with no improvement. Returned on 01/11/2021 with fatigue, elevated temp 101.2, SOB, 02 Sat at 90%, Rocephin 1G IM administered, CXR revealed pneumonia. MD received call from patients husband stating worsening 02 Sat levels at 81-82%. Was transferred to hospital and admitted with pneumonia..",Not Reported,,Not Reported,Yes,,Not Reported,U,12/30/2020,01/11/2021,12.0,PUB,"Lexapro 20 mg daily, VitD 3 50,000 units twice daily, ASA 81 mg daily, NovoLog 100units s/s, Lantus 30 u BID, Pantoprazole 40 mg daily, Synthroid .05 mg daily, clopidolgrel 75 mg, daily, Hydorchlorithiazide-Losartan 12.5100 mg daily, Ator",,"IDDM, Type1, HTN ,Migraine HA",,"cipro, Morphine, Flagyl, Augmentin","['Chest X-ray abnormal', 'Chills', 'Cough', 'Dyspnoea', 'Fatigue', 'Headache', 'Influenza virus test negative', 'Oxygen saturation decreased', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test negative', 'White blood cell count decreased']",1,MODERNA,IM 941743,NY,60.0,F,"This person was found to be deceased on routine rounds during the night, 3am. No symptoms of reaction noted post vaccine. No injection site reaction. No reports of any allergic reaction.",Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,OTH,"Amitiza, Anastrozole, Calcium Carbonate, Levemir, Novolog, Docusate, Fiber Lax, Fluvoxamine Maleate, Gavilax, Glucerna, Ketoconazole, levetiracetam, loratadine, Selenium sulfide lotion, vimpat, vitamin D3, Prolia AS needed medications: fle",None,"Benign polycythemia, Type II DM, Anxiety, Epilepsy, Blepharitis (bilateral), cataract (not specified), Allergic rhinitis, constipation, scoliosis, osteoporosis, dyspahgia, urinary incontinence, Dermatitis, breast cancer (right breast lumpectomy), history of respiratory infection, DNR AND MOLST were in place at time of death",,No known drug or food allergies,['Death'],1,MODERNA,IM 941759,AL,69.0,F,"numbness on right side of face spreading to head and neck. prescribed prednisone, valcyclovir. multiple MRI with no conclusion",Not Reported,,Not Reported,Not Reported,,Yes,N,03/07/2019,05/01/2019,55.0,PHM,,no,,,codeine,"['Hypoaesthesia', 'Magnetic resonance imaging']",2,GLAXOSMITHKLINE BIOLOGICALS,IM 941811,LA,56.0,F,"Resident began having fever on 1/11/21 @0600. VS= T-102 B/P- 100/57 P- 112 RR- 24 O2 Sat 92% on RA. MD called. Rapid COVID Test was negative. CBC,CMP, U/A were ordered as well as CXR. Resident's condition declined. At 3:00pm resident started having respiratory distress and hypoxia O2 Sat 89%. Supplemental O2/mask @ 5LPM. Neb TX, EKG, and Rocephin 1 GM ordered. Condition worsened. Resident sent to nearest ER for evaluation. Later in the evening the staff AT Medical Center called to inform staff that resident had expired @ 2230 as a result of Respiratory Failure and Sepsis.",Yes,,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/11/2021,7.0,SEN,"Haldol 2mg TWICE DAILY, DEPAKENE 750MG THREE TIMES",NONE,"HUNTINGTON'S CHOREA, HTN, HLP, HYPOTHYROID, DEPRESSION, CONSTIPATION, AND DYSPHAGIA",,NKDA & NO FOOD ALLERGIES,"['Albumin urine present', 'Bacterial test positive', 'Chest X-ray abnormal', 'Death', 'Hypoxia', 'Lung infiltration', 'Pyrexia', 'Respiratory distress', 'Respiratory failure', 'SARS-CoV-2 test negative', 'Sepsis', 'Urine leukocyte esterase positive', 'White blood cell count normal', 'White blood cells urine positive']",1,MODERNA,IM 941834,CA,61.0,M,"about 14 hours after vaccination I experienced what appeared to be a severe case of Cytokine storm. I had a moderate case of COVID in May 2020 and had positive IgG AB in August. The symptoms started with heavy shaking chills, lasting 1 1/2 hours , fever and most concerning sustained tachycardia with heart rate of 180' to 200' over hours, which then destabilized into runs of Vtach and complex ventricular dysrythmia, low BP, profound weaklness, head aches and joint and muscle pains ( similar to the experienced COVID symptoms )",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Vitamin D, C, Zinc, Selenium, Tamsolusin, Rosuvastatin, Aspirin",no,no,,NKA,"['Arthralgia', 'Asthenia', 'Chills', 'Cytokine storm', 'Headache', 'Hypotension', 'Myalgia', 'Pyrexia', 'Tachycardia', 'Ventricular arrhythmia', 'Ventricular tachycardia']",UNK,MODERNA, 941868,TX,59.0,F,"-FEVER 101, BODY ACHE, HEADACH, FATIGUE, RUNNY NOSE , - Began within 6 hours Naprosyn helped, Tylenol did not. TXT symptomatically with Pepcid, Claritin, tylenol, Naprosyn",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/12/2021,1.0,WRK,ON 1st FORM,,"Increased Chole. HB - PRESSURE, GLACOMA, PRE-DIABETIC",,,"['Fatigue', 'Headache', 'Pain', 'Pyrexia', 'Rhinorrhoea', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,IM 941897,CA,87.0,F,"Patient reported right knee, joint pain on 01/12/2021. Patient took 200mg Ibuprofen in AM and 650mg Tylenol PM. Pain has resolved by 01/13/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/12/2021,1.0,OTH,,None,,,NKDA,['Arthralgia'],UNK,MODERNA,IM 941906,IA,58.0,F,"Patient started having symptoms like a cold on January 1, 2021. She attributed them to having had the vaccine 3 days prior. Her husband started getting sick a couple days later and was sent home from work to be tested for COVID. When he went, she went as well to be checked out. She tested positive on January 6,2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,PHM,,,,,,"['COVID-19', 'Nasopharyngitis', 'SARS-CoV-2 test positive']",1,MODERNA,IM 941916,LA,35.0,M,"Patient vaccinated at 1501, beginning 1531 started with itching, wheezing and shortness of breath. Treated in the ED with Epi 1 mg SQ, , Solumedrol 125 mg IVP and Benadryl 25 mg IVP and Albuterol 2.5 with atrovent .5 mg.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,PVT,Vyvanse 60 mg and Albuterol Sulfate inhaler,None,ADHD and Asthma,,"Flu Vaccine, Cephalosporins, Morphine, TB skin test","['Dyspnoea', 'Pruritus', 'Wheezing']",2,PFIZER\BIONTECH,IM 941929,NY,51.0,F,"12/31/2020: Fatigue - lasting 1 day 12/31 - 1/4/2021: Injection site pain 12/5/2021 - Present: Pain underside of left arm raidiating into arm pit down along left side into left breast initial pain scale is 4/3 increasing to present pain scale of 8 out of 10. Neg redness, neg. swelling. Palpable extreme pain. Inability to move / use left arm. Pain with motion - reaction is progressing interesting",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/08/2021,8.0,PVT,"omeprazole, librax, dicyclomine metformin, ambien, zinc, vitC",0,Diabetes 2,,Minocycline,"['Axillary pain', 'Breast pain', 'Fatigue', 'Injected limb mobility decreased', 'Injection site pain', 'Pain']",UNK,MODERNA,IM 941936,TX,39.0,F,"Internal Hemorrhage (GI) & urinary Muscles aches chills (L) side pain after 2 days post COVID vaccine #1 & after 1 day post COVID vaccine # 2 Hemorrhoids, bright red blood per rectum. Saw GI doctor. C/o platelet count (low normal)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/20/2020,2.0,WRK,None,None,None,,NKDA,"['Chills', 'Haemorrhoids', 'Internal haemorrhage', 'Laboratory test', 'Rectal haemorrhage', 'Urethral pain']",1,PFIZER\BIONTECH,IM 941937,IL,59.0,F,"Patient received vaccine at 0939. 30 minute wait period related to history of previous anaphylactic reaction. 10:05 patient walked from observation area to vaccinator and reported that her ""chest was burning"" and ""feels like it is getting tighter to breathe. Pt had change in voice. Patient moved to chair and started on oxygen 1.5 L/m per nasal cannula. MD came to room to assess patient. ED arrived and checked patient B/P. Patient transferred by cart to ED.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/12/2021,01/12/2021,0.0,PVT,,,,,"Codiene, Compazine, Macrobid, Sulfa Drugs, traMADol","['Chest pain', 'Dysphonia', 'Dyspnoea']",1,MODERNA,IM 941992,OR,25.0,F,"Patient began having cramping of her upper extremities and subsequent swelling of her face and neck and also shortness of breath, chest pressure and flushed appearance. She denies any tongue or throat swelling. She is also complaining of bilateral arm pain. The initial reaction treatment was started in the conference room and then the patient was transferred to the emergency room. She continued to has arm and chest pain in the emergency room. She had muscle tension/rigidity in the upper extremity which caused significant pain. She also developed a nonspecific rash on the chest and abdomen that persisted for through out he hospital stay. Treatment was started with epinephrine 0.5 mg IM x2 and diphenhydramine 50 mg IM x1, prior to transfer to emergency room. In the emergency room treatment was dexamethasone 10mg IV x 1, famotidine 20mg IV x1, Ketorolac 30mg IV x 1, lorazepam, 1mg IV x 2, morphine 4mg IV x 2, 1000ml Saline Solution. As an inpatient the treatment included scheduled acetaminophen 500mg TID, as need morphine for pain after treatment with fentanyl, scheduled diphenhydramine 25mg IV q8 and compazine 5mg IV for nausea, cyclobenzapine 10mg as need for muscle spasms, dexamethasone as a scheduled dose started at 4 mg BID and tapered to 2 mg BID, Naproxen 500mg BID and Norco 7.5/325 as need for pain. with famotidine 20mg BID .",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"ETONOGESTROL 68 MG IMPLANT EVERY 3 YEARS, OMPERAZOLE 40MG DAILY, RIZATRIPTAN 10 MG AS NEEDED FOR HEADACHE",MIGRAINE HEADACHES,SURGICAL TREATMENT OF PERFORATED ULCER,,NO KNOW DRUG ALLERGIES,"['Blood electrolytes', 'Chest discomfort', 'Chest pain', 'Dyspnoea', 'Flushing', 'Full blood count', 'Muscle rigidity', 'Muscle spasms', 'Muscle tightness', 'Nausea', 'Pain in extremity', 'Rash', 'SARS-CoV-2 test', 'Swelling', 'Swelling face']",1,MODERNA,IM 941994,TX,36.0,F,Note: I am currently breastfeeding. Had body aches; chills; fever of 102.6; headache; nausea; cough; shortness of breath - I went to ER and that is where I received COVID positive test and positive tests for COVID Pneumonia and Microplasm Pneumonia as well. Stayed overnight in ER observation - 2 am to 8 am . Went home next morning and was quarantined approximately 8 days. Body aches and a cough had started two days prior to injection. IV antibiotics at the hospital and oral antibiotics at home. Received nebulizer breathing treatments. Pain meds and anti-inflammatory medication.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,Norethindrone - .35mg/day; Nasacort - 2 sprays a day; Symbicort - 160/4.5 - 2 puffs 2x/day; 600mg of Calcium/day; 10 mg of Zyrtec; 1 x/day prenatal vitamin; 500 mg of Valacyclovir; Colace =100 mg/day; Escitalopram - 20 mg/day; Omeprazole -,Covid - positive test after vaccine that same day Myoplasm pneumonia - positive test later that same day. Anemia - new diagnosis on that same day.,depression; anxiety; asthma; migraines; chronic constipation; seasonal allergies;,,no,"['Anaemia', 'Blood test', 'Chills', 'Computerised tomogram', 'Cough', 'Dyspnoea', 'Headache', 'Mycoplasma test positive', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 942002,MN,26.0,F,Onset of tachycardia was 8:30pm on 1/12/21 with a noted HR of 164 and SR. Went to ER and had HR of 171 upon arriving to triage window. EKG said Sinus Tachycardia. Admitted to observation station with telemetry to monitor HR. HR normalized around 100 when up and walking at 10:45am on 1/13/21.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/12/2021,01/12/2021,0.0,PVT,"Adderall, modafinil, duloxetine, Latuda, Rybelsus, levothyroxine, topamax, spironolactone, prazosin, trazodone, gabapentin, Ativan, pindolol, fludrocortisone, Seasonale birth control",,"POTS, idiopathic hypersomnia, PCOS, hypothyroidism, depression, anxiety, PTSD, PMDD, Diabetes Type 2",,Metformin,"['Blood bicarbonate decreased', 'Blood glucose normal', 'Blood thyroid stimulating hormone normal', 'Chest X-ray normal', 'Electrocardiogram abnormal', 'Full blood count normal', 'Glycosylated haemoglobin increased', 'Metabolic function test', 'Sinus tachycardia', 'Tachycardia']",2,PFIZER\BIONTECH,IM 942029,TN,43.0,F,"I received my covid vaccine on 12/29/2020 at 4:42pm. In 10 minutes after the shot, I went into anaphylactic shock, I broke out in hives, and my throat was closing",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,12/29/2020,12/29/2020,0.0,WRK,"Zoloft, Valsartan, propranolol, lasix,",None,"Htn, asthma, diabetes environmental allergies",,"Contrast dye, triptans, Topamax, imitrex,reception, pravastatin, CATS( HAIR AND DANDER, pfizer-biontech covid 19 vaccine","['Anaphylactic shock', 'Throat tightness', 'Urticaria']",1,PFIZER\BIONTECH,IM 942030,OR,45.0,F,Pt reported chest tightness and throat tightness following vaccination. Time course following vaccination unknown.,Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/11/2021,01/11/2021,0.0,PVT,unknown,unknown,none,,penicillin,"['Chest discomfort', 'Throat tightness']",2,PFIZER\BIONTECH,IM 942040,IA,78.0,M,"little bit of a reaction light headed after 5 minutes. vitals were low, so observed for 30 minutes after being light headed. Patient was found unresponsive and pronounced dead later that day.",Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/13/2021,0.0,SEN,unknown,none,yes,,unknown,"['Death', 'Dizziness', 'Unresponsive to stimuli', 'Vital functions abnormal']",UNK,PFIZER\BIONTECH,IM 942072,VT,87.0,F,Death occurred 3 days after vaccine receipt; attributed to complications of her chronic advanced dementia with aspiration at age 87. No evidence of acute vaccine reaction.,Yes,01/05/2021,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/05/2021,3.0,SEN,"Tramadol, risperidone, fluoxetine, cyanocobalamin, colchicine, torsemide, levothyroxine",aspiration pneumonia- completed treatment prior to vaccination.,"Advanced dementia with severe violent behavioral symptoms. Progressive decline and frailty due to late stage dementia with likely terminal aspiration after completion of treatment for previous aspiration pneumonia. Death attributed to complications of her advanced dementia. No evidence of acute reaction to vaccine (rash, dyspnea, swelling, redness). Chronic kidney disease, hypothyroidism, type 2 diabetes, gout, B12 deficiency",,No known allergies,"['Aspiration', 'Death', 'Dementia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 942085,KS,62.0,F,"No adverse effects from vaccination seen on 1/2/21. On 1/6/21 resident was seen by Dr and her baclofen pump was refilled with 20 ml Baclofen 4,000mcg/ml. ITB Rate increased by 6% to 455.5 mcg/day simple continuous rate over 3 days. On 1/8/21 at 0615 resident was shaking, lower extremities mottled, Sa02 70%, pulse 45. Oxygen started at 2 L/m per NC. At 0715 her primary physician was notified as well as her daughter. Oxygen increased to 4 L/min, sats at 83%. SOA noted, reported all over pain. At 0850 when they attempted to reposition the resident, she was not responsive. Licensed nurse assessed her and no heartbeat heard or pulse found.",Yes,01/08/2021,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/08/2021,6.0,SEN,"Ativen, Butrans Patch, Tylenol, Potassium Citrate-Citric Acid","Medical diagnosis: quadriplegia, Atherosclerotic heart disease",see #11.,,"Amoxicillin, Clavulanic Acid, Codeine, Morphine, Pencillin","['Dyspnoea', 'Livedo reticularis', 'Pain', 'Pulse absent', 'Tremor', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 942093,OR,52.0,F,"I had a mild headache the evening of the shot, I had a headache the next two days that was relieved by Advil. I had a very sore arm at the injection site Friday and Saturday after the shot was given. The arm pain was gone Sunday morning. I was very tired on Saturday especially and slept through the morning and early afternoon on and off until about 3:00 pm. On Friday during the day, I noticed my right ear starting to feel unusual and uncomfortable. On Saturday, the ear issue continued, I felt like I had some hearing loss and a constant buzzing and ear fullness feeling. On Sunday, the ear issued continued with the hearing loss, buzzing and fullness and has through today and hasn't stopped. I tried some nasal decongestant on Sunday afternoon, but it didn't have any effect. I made an appointment with the ENT doctor on Monday morning for Tuesday. I had a hearing test on Tuesday and saw the ENT doctor on Wednesday. He prescribed prednisone and ordered an MRI. I will be starting the prednisone later today (Wednesday) when the pharmacy has the prescription ready.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/07/2021,01/08/2021,1.0,WRK,"Junel, pantoprazole, vitamin B-12, vitamin D, loratadine, fluoxetine",none,"acid reflux, allergies","Tetatus, Pertussus, Diptheria, on 7/17/2012 my arm swelled at the injection site and became very warm, I was about 44 years old","Clindamycin, nickel, latex (sensitivity to latex on face only)","['Acoustic stimulation tests', 'Deafness', 'Ear discomfort', 'Fatigue', 'Headache', 'Injection site pain', 'Tinnitus']",1,PFIZER\BIONTECH,SYR 942106,CA,54.0,M,"54 y/o M with PMH of HTN, HLD, Alcoholic Cirrhosis, Aortic Valve Stenosis, and angina BIBA as a Medical Alert for cardiac arrest noted PTA. Per EMS, the patient called because he was having constant, diffuse abdominal pain x 1 day that radiated to his chest. On scene, the patient had a witnessed arrest with EMS starting CPR. He was given 3 rounds of epi without ROSC. Pt had no associated shockable rhythm. Of note, pt's wife, had noted pt had received covid vaccine the prior day.",Yes,01/09/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Abdominal pain', 'Cardiac arrest', 'Chest pain', 'Pain', 'Pulse absent', 'Resuscitation']",UNK,PFIZER\BIONTECH, 942197,OK,74.0,F,"A few minutes after the vaccine, she had mild tongue swelling. It only lasted a few minutes, and then she felt fine. However, her BP went up. I'm not sure how high. she then has a short run of asymptomatic V tach. Taken to hospital observed overnight. No further events or problems.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/12/2021,01/12/2021,0.0,PUB,"Buspar, Lexapro, fish oil, Xanax, vistaril. lisinopril, vitamin D. levothyroxine, probiotc",,"HTN, hyperlipidemia, hypothyroidism, GERD, history of breast cancer",,NKDA,"['Blood pressure increased', 'Echocardiogram normal', 'Electrocardiogram normal', 'Laboratory test normal', 'Swollen tongue', 'Ventricular tachycardia']",1,MODERNA,IM 942237,OK,63.0,F,"She got the vaccine on Dec 23, and then on Jan 4 she had a mild stroke with left sided arm and face weakness. She did recover fully. She already has known CAD and risk factors for CVD. It is possible, but by no means certain, that the vaccine was an indirect cause of the event. Since the vaccine provoked an immune response, as it was supposed to, it is possible that this inflammation may have set up a metabolic predisposition that may have contributed to the event, which was 12 days later.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,12/23/2020,01/04/2021,12.0,PUB,"Aspirin, atorvastatin, citalopram, metoprolol, vitamin D.",,"CAD, hyperlipidemia, HTN, smoker",,"sulfa, nicotine patch adhesive","['Angiogram cerebral abnormal', 'Cerebral artery stenosis', 'Cerebral infarction', 'Cerebrovascular accident', 'Facial paresis', 'Hemiparesis', 'Lacunar infarction', 'Magnetic resonance imaging brain abnormal']",1,PFIZER\BIONTECH,IM 942240,LA,83.0,F,"New onset altered mental status after fall. Per son, she was found in bed, unresponsive at around 12:15 AM on 1/10 by her husband. Brought to the emergency room and admitted, Began treatment for UTI w/ CTX. Discharged 1/11/21 with f/u appointments",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/04/2021,01/10/2021,6.0,PVT,,,,,no known allergies,"['Fall', 'Mental status changes', 'Unresponsive to stimuli', 'Urinary tract infection']",1,PFIZER\BIONTECH,IM 942246,OR,1.0,M,"On 12/20/2020, dad of patient called our office after hours. Nurse triage line took the call. Dad's reported that pt had a fever of 100.6 F (max temp) and hard stools. Pt was given a dose of Tylenol and 10-15 minutes later, pt vomited. Triage nurse advised that dad follow up with PCP office when open in the AM. Dad called our office at 10:25am on 12/21/2020 stating that pt fever had lifted, but pt vomited a total of 5 times since the night before, with the last episode at 7:45 am on 12/21/2020. Pt had adequate fluid intake and urine output and stool had softened. MA advised continued home care. Appropriate triage advice was given and documented. At 16:43(pm) on 12/21/20, dad called back to clinic stating patient symptoms had worsened and they were at the emergency department. Dad disconnected call before speaking with the MA. The MA attempted to call dad back, but there was no answer. A message was left for dad to return call. On 12/22/20 at 12:44(pm), dad called in to clinic to report that pt had died- cause unknown. Our clinic obtained records from Hospital. The ED report stated that pt presented to the emergency department via EMS Code 3 in cardiac arrest. Unknown downtime prior to the initiation of chest compressions. Pt was staying with grandparents. When grandma went to wake pt from his nap, he was not responsive. When grandma tried to pick him up, there was possibly some brief, generalized seizure activity as well as coughing and gagging. Child remained unresponsive and was taken by private vehicle to outside Urgent Care where pt was found to be apneic and in asystole. An AED was applied, no shock advised. EMS was called and CPR was started. EMS placed an endotracheal tube and established IO access. 4 rounds of epinephrine were administered during the course of the prehospital resuscitation which was approximately 15-20 minutes. Presenting rhythm was asystole. No change in rhythm upon transport and arrival. Immediately upon arrival the pediatric transport team was activated and the pediatric intensivist was paged. Chest compressions were resumed according to protocol. Additional inter osseous access was established in the left proximal tibia. Fluid bolus was initiated. Serial doses of epinephrine were administered every 4 minutes throughout the resuscitation. The child also received several boluses of IV bicarb. Online consultation by ED physician with PICU attending was established early in the resuscitation course. It was agreed by ED physician and PICU attending that the peds transport team would be dispatched urgently to the ED location in anticipation of possible ROSC and need for emergent transport to PICU. It was agreed by ED physician and PICU attending that transportation would not be initiated with the child still undergoing resuscitation requiring chest compressions prior to ROSC. Initially, endotracheal tube position felt to be acceptable based on the clinical evaluation, however chest x-ray did demonstrate some degree of right mainstem intubation, after which the tube was pulled back approx 2cm and subsequent x-ray showed the ETT tip in good position approx 1 cm above the carina. Initial end-tidal CO2 was 14 on arrival, this continued to trend downward until undetectable throughout the course of the resuscitation. At no point were there palpable pulses or other evidence of return of circulation throughout the resuscitation. Capillary blood glucose was initially undetectable. The child received serial boluses of D 25 via IO line for a tital of 30 g dextrose after which CBG ultimately came up to 244. Multiple efforts were made throughout the resuscitation to achieve IV access and to obtain blood for laboratory studies. All efforts were unsuccessful, making it impossible to obtain any labs throughout the course of the resuscitation. Attempts to obtain even capillary blood samples via heel stick for CBG measurements were extremely difficult. Resuscitation continued for 49 minutes after ED arrival. A total of at least 65 minutes of CPR time. Bedside ultrasound was used to look for cardiac activity during the last 5 pulse checks of the resuscitation, demonstrating cardiac standstill. Despite the efforts and interventions mentioned, ROSC was never obtained and the code was discontinued at 17:03(pm). The child's parents were informed of his death upon their arrival to the ED at approximately 17:40(pm). Family was given time with the pt. The medical examiner arrived and discussed case at 19:11(pm). At 19:49(pm) Medical Examiner was interviewing grandparents along with 2 County Detectives. The medical examiner took custody of the pt at 21:52(pm). Evidence bag was sent with the medical examiner. Pt received vaccinations 10 days prior to death. We are still waiting for M.E. report, as we do not have any further information as to why pt passed.",Yes,12/21/2020,Not Reported,Not Reported,,Not Reported,N,12/11/2020,12/20/2020,9.0,PVT,Enfamil Gentlease Formula,No known illness.,No known chronic/ long-standing health conditions.,,NKMA,"['Autopsy', 'Blood glucose decreased', 'Blood glucose increased', 'Cardiac arrest', 'Chest X-ray abnormal', 'Cough', 'Death', 'Echocardiogram abnormal', 'End-tidal CO2 decreased', 'Endotracheal intubation', 'Endotracheal intubation complication', 'Faeces hard', 'Infantile apnoea', 'Pulse absent', 'Pyrexia', 'Resuscitation', 'Retching', 'Seizure', 'Unresponsive to stimuli', 'Vomiting']",1,MERCK & CO. INC.,SC 942252,PR,31.0,F,"Rash, hot area and prickly rash Nasal congestion",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/09/2021,7.0,UNK,,,,,Iodine shellfish Cipro medication,"['Miliaria', 'Nasal congestion', 'Rash', 'Skin warm']",1,MODERNA,SYR 942290,CA,89.0,F,"Resident received 1st dose on 1/4/2021. On 1/6/2021 resident having SOB, increased weakness with O2 sats at 91% RA. On 8th resident sustained a fall, O2 sats 88-92, dizzy, weakness. Rapid COVID test performed with negative results. Evening of 8th resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the ER on 1/9/2021 with new diagnosis of Leukemia and orders for hospice. Continued with fever, crackles and N/V and loss of appetite from the 9th and 10th of January. Resident expired at 820am on 1/11/2021.",Yes,01/11/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,SEN,"Tylenol, tylenol with codeine, Artificial Tears, ASA, Cal-Mag-Zinc, Claritin, Sertraline, Melatonin, MOM, Latuda, Estradiol, Gabapentin, Alendronate, Atorvastatin, Multi-Vit",,"Glaucoma, Low back pain, restless leg syndrome, Osteoporosis, Compression Fx-Lumbar",Influenza Virus Vaccines - Unknown date/type or brand,Dilaudid; Morphine Sulfate; Sulfonamides; Influenza Virus Vaccines,"['Asthenia', 'Crepitations', 'Death', 'Decreased appetite', 'Dizziness', 'Dyspnoea', 'Fall', 'Hospice care', 'Hyperhidrosis', 'Lethargy', 'Leukaemia', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting']",1,PFIZER\BIONTECH,IM 942381,MA,43.0,F,"I had a headache at the top of my head, and a tingling sensation down my left leg from my buttocks to my calf. The tingling lasted until the next morning then went away. On 1/3/2021 I experienced a strong headache followed by facial numbness and tingling. This lasted for an hour or so and slowly subsided. The headache lingered for 3 days.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/02/2021,01/11/2021,9.0,WRK,"Pantoprazole, Multivitamin (gummies)",None,Gastritis,,Bees,"['Blood test normal', 'Chest X-ray normal', 'Electrocardiogram normal', 'Headache', 'Hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 942495,ME,29.0,F,"itchy, red, warm, painful (similar to discomfort immediately after injection). Warmth and pain dissipated within 3 days, redness and intermittent itchiness remained through this point; but improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/31/2020,01/07/2021,7.0,UNK,"vitamin D, Prenatal Vitamin, Vitamin C, Zinc",no,no,,Amoxicillin- Rash,"['Erythema', 'Pain', 'Pruritus', 'Skin warm']",1,MODERNA,IM 942500,CA,75.0,U,"Resident was observed closely s/p COVID-19 vaccination on 1/12/2021 for 30 minutes per plan of care. No c/o of pain or discomfort. No adverse reaction noted. Overnight shift continued to monitor with no alteration to baseline. No c/o breakthrough pain reported, slept well. Received by AM RN on 1/13/2021 alert and verbally responsive at baseline. Multiple staff assisted with needs including colostomy care, meals, ADLs etc with no change reported by resident or observed by staff. During routine med rounds at appx 11:45am, RN on duty observed pt was non responsive verbally or to tactile stimuli. Assessed immediately with no rise and fall of chest, no pulse, no resp.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/12/2021,01/13/2021,1.0,UNK,,,,,,"['Chest expansion decreased', 'Pulse absent', 'Respiratory arrest', 'Unresponsive to stimuli']",UNK,PFIZER\BIONTECH,SYR 942879,HI,53.0,M,"Received 2nd vaccination in series on 11 JAN 21. By next morning started to experience some muscle and joint symptoms. By afternoon of 12 JAN 21 experienced sudden onset loss of bladder control for first time in his life, followed a few hours later by blurry vision, vertigo, motion sickness, emesis and cold sweats that drenched his clothes. Taken to ER by paramedics, and admitted for further observation and evaluation for underlying neurologic vs. cardiogenic problems. Given positional treatments by PT for possible otoliths. Feels much improved on afternoon of 13 JAN 21, but symptoms not fully resolved. Will likely be discharged from hospital on 14 JAN 21 if problems continue to resolve.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/11/2021,01/12/2021,1.0,MIL,"LIPITOR, CYMBALTA, 81 MG ASA",,"PTSD, SCIATICA",,"PEANUTS, OXYCODONE, PCN, PRAZOSIN, AMIDE CLASS ANESTHETICS","['Arthropathy', 'Chest X-ray normal', 'Cold sweat', 'Computerised tomogram head normal', 'Computerised tomogram neck', 'Echocardiogram normal', 'Hyperhidrosis', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging neck', 'Motion sickness', 'Muscle disorder', 'Troponin I increased', 'Urinary incontinence', 'Vertigo', 'Vision blurred', 'Vomiting']",2,PFIZER\BIONTECH,IM 942886,PA,84.0,M,"Admission Note: ? Weakness - Generalized � � Patient reports feeling weak prior to dialysis, but demanded clinic to perform dialysis. Had full tx done and brought to ER. Reports still feels weak after dialysis. � 84 year old male comes in today after completing dialysis for evaluation of generalized weakness x 5 days. He has also lost his voice. He tells me he received his COVID vaccine yesterday, but he is concerned he may have COVID. He denies any fevers, cough, sore throat, NVD, abd pain. Transfer Note: HOSPITAL COURSE: Patient is a 84 y.o. male who presented with shaking chills and was found to have Gram-negative rods in the blood. The source of infection was unclear. Initially it was thought that it could possibly be cholecystitis but imaging was negative for that. There was concern that it could be UTI but the patient is on dialysis and is an uric and therefore no urinalysis could be got. Early this morning when I saw the patient the patient did have significant pain and tenderness in the right knee and is not able to put weight on that. I.e. Consulted Dr. Today with per lumbar from Orthopedics who said that it would be in the best interest of the patient for him to be transferred to hospital where he could decide on aspiration and or washout of the right knee. � Transfer center has been called and we are trying to finalize a transfer of the patient hospital at this point of time � Please see problem list listed below. � REASON FOR ADMISSION/ ADMISSION DIAGNOSES � Sepsis cause unclear",Not Reported,,Not Reported,Yes,11.0,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,"Medication List As of 1/6/2021 11:25 AM amLODIPine Besylate 5 mg Oral Apixaban 5 mg Oral 2 times daily Aspirin 81 mg Oral Daily Cholecalciferol 10,000 Units Oral 2 times weekly cloNIDine HCl 0.1 mg/day Transdermal Weekly Clopidogrel B",,? Atrial fibrillation (HCC) � ? Cancer (HCC) � � prostate cancer ? Cardiac disease � ? CHF (congestive heart failure) (HCC) � ? Diabetes mellitus (HCC) � ? GERD (gastroesophageal reflux disease) � ? Hyperlipidemia � ? Hypertension � ? Renal disorder � � end stage renal,,Atorvastatin Iodinated Diagnostic Agents Metrizamide Nsaids All statins Tolmetin,"['Aphonia', 'Arthralgia', 'Ascites', 'Asthenia', 'Bacterial infection', 'Bilirubin conjugated increased', 'Blood lactate dehydrogenase increased', 'Chest X-ray abnormal', 'Chills', 'Cholelithiasis', 'Computerised tomogram abdomen', 'Device dependence', 'Diverticulum intestinal', 'Gastrointestinal oedema', 'Gram stain negative', 'Intraductal papillary mucinous neoplasm', 'Magnetic resonance imaging abdominal abnormal', 'Pulmonary vascular disorder', 'Renal cyst', 'Retroperitoneal oedema', 'Salmonella test positive', 'Sepsis', 'Splenomegaly', 'Troponin I increased', 'Ultrasound Doppler normal', 'Ultrasound abdomen abnormal', 'Weight bearing difficulty', 'White blood cell count increased', 'X-ray limb normal']",1,MODERNA,IM 943606,VA,52.0,F,-Tingling in roof of mouth without swelling then pt stated back of throat feeling numb & swollen,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,01/11/2021,0.0,PUB,"HCTZ Vitamin E, D ceterozin omeprazole zine Flonase",HTN - Acid Reflux - Environmental induced allergies,,,Peaches,"['Paraesthesia oral', 'Pharyngeal hypoaesthesia', 'Pharyngeal swelling']",1,MODERNA,IM 943624,,58.0,M,Anaphylaxis tongue swelling and throat soreness Narrative: developed throat pains and tongue swelling 1/6/21 whereas mRNA vaccine Covid 19 Pfizer was given at Hospital. Advised not to taken 2nd dose until etiology of tongue swelling and throat pains identified. His 1/6/2021 covid 19 test (biofire- which include Covid 19 infection and all possible viral etiology was negative.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/06/2021,,OTH,,,,,,"['Anaphylactic reaction', 'Oropharyngeal pain', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 943803,CA,58.0,M,About an hour after the vaccine I went out for lunch and was eating some radishes and felt sensitivity on my tongue. It passed in about 5-minutes. I noticed the sensation because I was hypervigilant about any sensations I might be feeling after the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,UNK,omezeprole; terbinafine (generic Lamisil),no,GERD,,no,['Glossodynia'],UNK,MODERNA, 943817,ME,40.0,F,"Following day patient developed fever 103, chills, vomiting, 48 hours after vaccine patient developed diarrhea which lasted 2 days. She was covid tested 1/9/2021 which was negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,WRK,"Birth control, Advair, Albuterol",denies,"Asthma, Allergies",,"PCN,-hives, angioedema, cantalope, trees, grass, cashews, Cas Caesin from milk","['Chills', 'Diarrhoea', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting']",1,PFIZER\BIONTECH,IM 943842,IA,58.0,M,"Vacianted at 12;45pm, 4pm arm began to hurt, 12midnight skin started to feel like it was burning, took cold shower. 12/31/2020 - 6am-woke up large knot on arm at injection site, arm hurt, arm felt heavy, rash from elbow to fingers on both arms. Fever -102/7, took 50mg Benadryl, 20 mg Pepcid AC, Tylenol for fever, Albuterol breathing treatment. Went back to sleep. Awoke around 2pm- felt better, arm continues to be sore. No rash, no burning of skin, no itching. Discussed s/s to look for and advised if symptoms reoccur and get worse, call 911. He stated he is a nurse and knows what to do. I asked him did he sign up for V-Safe , encouraged him to sign up and record his information. He stated he would - RN",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PUB,albuterol for asthma,no,,,"coedine, bee stings","['Injection site nodule', 'Limb discomfort', 'Pain in extremity', 'Pyrexia', 'Rash', 'Skin burning sensation']",1,MODERNA,IM 943903,,43.0,F,"HYPERtension chest pain (mild), anxiety",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,OTH,,,,,,"['Anxiety', 'Chest pain', 'Hypertension']",2,PFIZER\BIONTECH,IM 943910,TN,76.0,F,"Had small, hard, painful knot at injection sight after shot that lasted 3 days and went away Itches, slightly tender to palpation, red 16.5 cm X 8.5 cm on R arm, anterior lateral aspect Treatment: Steroid injection - Cephalexin, Claritin, Famotidine, steroid cream - Triamcinolone, Salonpas liquid lidocaine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/09/2021,7.0,PUB,"Cephalexin Cap 500 mg, Famotidine Tab 20 mg, Levothyroxine Sodium Tab 100 MCG, Meloxicam Tab 15 mg, Omeprazole Cap delayed rel 20 mg sig, Triamterene-HCTZ tab 37.5/25 mg, Xanax Tab 0.5 mg, Biotin Cap 5000 MCG, Vitamin B-12 Sublingual Tab Su",See attached,"Hypothyroidism due to acquired atrophy of thyroid, Hypertension, GAD (generalized anxiety disorder), Insomnia, Reflux, Back pain, Neck pain, Chronic pain hip, knees, back, Trigeminal neuralgia, Melanoma",,NKDA,"['Injection site erythema', 'Injection site induration', 'Injection site nodule', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,SYR 944436,MN,46.0,F,"chills, Fever, body aches, my coughing came back I think from covid Fine now",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/08/2021,2.0,SEN,,Covid,,,"Latex gloves, Amoxillion","['Chills', 'Cough', 'Pain', 'Pyrexia']",UNK,MODERNA, 944446,KS,31.0,F,"Patient started to have a local injection site reaction on 1/10/21 at around 9:10am. The injection site had some redness and swelling. By the afternoon on 1/10/21 the red and swelling increased and by 1/12/21 the redness was the size of a half dollar and swelling just beyond the redness. The area is warm to touch. Pt also had symptoms of nausea, fatigue, and muscle pain. Pt was instructed to take Zyrtec BID & pepcid. When I talked to the patient on 1/13/2021, the injection site remains the same and still feels nauseated.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/10/2021,1.0,PVT,"Amlodipine, buspirone, ergocalciferol, fluconazole, Fluoxetine, hydrochlorothiazide, ivermectin, levothyroxine, metformin, wellbutrin XL",Na,"depressive disorder, anxiety, diabetes mellitus","Pneumovax-23 local injection site red & swollen, hives.",pneumovax-23,"['Fatigue', 'Injection site erythema', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,IM 944466,MN,55.0,F,"chills, bad headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/10/2021,4.0,SEN,,,,,,"['Chills', 'Headache']",UNK,MODERNA, 944481,PA,38.0,F,"Patient presented to Facility MD Experiencing Flushing, HA, elevated BP, Faint with Rapid HRT Beat. She was given water, Juice and laid down. After 30-40 minutes sxs subsided. Spoke to pt said she was Feeling much Better. Spoke to nurse at Rehab center. Pt reported she was Feeling much better By 5pm on 1-12-21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,SEN,,,,,No,"['Blood pressure increased', 'Dizziness', 'Electrocardiogram', 'Flushing', 'Headache', 'Heart rate increased']",1,PFIZER\BIONTECH,IM 944487,PA,33.0,F,had moderna covid vaccine yesterday at hospital 9 am states nurse was aware she had covid in december but talked to nurse and who reportedly talked ot cdc personnel who gave approval to give moderna vaccine saying if patient felt ok then ok to receive so was given following vaccine had arm pain and this lasted several hours last nite had trouble sleeping and woke up disoriented body hurts felt chills diarrhea and then on way to work vomited multiple times bilious now nausea no rash no fever but + chills and feels out of it right arm itchy red tender has headache confusion but denies sob advised will do Vaers and hold on second dose right now and work note Vaccine was given at Hospital on 1-12,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/12/2021,0.0,OTH,buproprion/ocp/clonazepam/metformin/sertraline/sprionolactone/,covid 19 infection december 9-2020,asthma,,cherry/penicillin/tetracycline,"['Chills', 'Confusional state', 'Diarrhoea', 'Disorientation', 'Erythema', 'Feeling abnormal', 'Headache', 'Insomnia', 'Nausea', 'Pain', 'Pain in extremity', 'Pruritus', 'Tenderness', 'Vomiting']",UNK,MODERNA, 944492,AL,27.0,M,"A few hours after my second dose on 1/08/2021, I had some adverse reactions that worried me, including arm numbness, tingling around my mouth and cheeks, a splitting headache/blurry vision, joint and muscle pain and dizziness. I called e-medicine and had a video call with a E-Medicine provider who told me to keep monitoring my symtoms and go to the ER if they got worse (fortunately they didn't); however there are some lingering effects. Currently I still am experiencing headaches (around my ears and temple area) with joint pain/body aches and occasional tingling/burning sensations in my fingers and feet.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,,,,,,"['Arthralgia', 'Burning sensation', 'Dizziness', 'Headache', 'Hypoaesthesia', 'Myalgia', 'Pain', 'Paraesthesia', 'Paraesthesia oral', 'Vision blurred']",2,PFIZER\BIONTECH,SYR 944498,NY,64.0,F,"Patient reports generalized warmth throughout her body, w/a metallic taste and a fever of 102, 24 hours post vaccination. She also reports extreme fatigue. With the administration of (2) doses of Tylenol 500mg the symptoms were relieved. Patient sought no medical treatment. Patient advised to take Tylenol prior to second series of Moderna vaccine requirement.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/12/2021,1.0,WRK,"Brilinta, Metoprolol, Lipitor, MVI",,CAD,,"PCN, Bactrim, Contrast DYE","['Dysgeusia', 'Fatigue', 'Feeling hot', 'Pyrexia']",1,MODERNA,SC 944514,,62.0,F,"Dizziness, Headache, Palpitations, HYPERtension, anxiety and stated SOB Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,OTH,,,,,,"['Anxiety', 'Dizziness', 'Dyspnoea', 'Headache', 'Hypertension', 'Palpitations']",2,PFIZER\BIONTECH,IM 944518,WV,33.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/11/2021,0.0,UNK,,,,,,['Unevaluable event'],UNK,MODERNA, 944521,CA,64.0,F,"Shingles, antiviral given, pain resolved but still has HA. Has followed up w/PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/07/2021,7.0,PVT,"Bacolen, aspirin, HCTZ, atenol, vit C, turmeric cranberry, Apple cider, potassium, mag, multivitamins, B complex",COVID 19 12/15/20,"Chronic LBP, HTN, hyperlipidemia",,"Effexor, Relafen, Robaxin, Duloxetine, Gabapentin, nortriptyline, pravastatin, Motrin","['Antiviral treatment', 'Headache', 'Herpes zoster', 'Pain']",1,MODERNA, 944540,CA,37.0,F,Patient calls 911 w/ anaphylactic reaction 45 MiNs s/p Moderna Covid-19 vaccine. x 4 0.3 mg Epi peNs given prior to ED arrival. Airway patent but difficulty speaky. Further ED treatments included IV MedicatioNs & breathy treatment.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,PUB,"Albuterol, BupropioN, Diphenhydramine, EPI Pen, Advair, ONdaNsetroN, Sertraline",,"Asthma w/ exacerbatioN,",,"Hydromorphone, Bee sting, CoNtrast, PeaNuts, VaNcomycin","['Anaphylactic reaction', 'Aphasia']",1,MODERNA,IM 944548,TX,53.0,F,"left arm vaccine site. Red swollen, Hot. Feels like a ball inside",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/13/2021,7.0,PVT,Vitamins,,,,,"['Injection site erythema', 'Vaccination site induration', 'Vaccination site swelling', 'Vaccination site warmth']",UNK,MODERNA, 944553,OR,22.0,F,"itchy throat, gave Benadryl 50mg - resolved. Then patient sxs returned + she went to ER (pharmacy staff not notified until after)",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/13/2021,0.0,UNK,,,,,,['Throat irritation'],2,PFIZER\BIONTECH,IM 963165,,95.0,M,1/11 asymptomatic COVID Positive test Narrative:,Not Reported,,Not Reported,Yes,,Not Reported,U,01/07/2021,01/11/2021,4.0,OTH,,,,,,['SARS-CoV-2 test positive'],1,MODERNA,IM 942569,OK,,U,"rheumatoid arthritis; ganglion cysts; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 28-JAN-2014, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: rheumatoid arthritis, and ganglion cysts (synovial cyst). The patient claimed damages as result of injury to themselves, and economic losses.The outcome of the events was not provided. Therefore, the causality for the events was related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of rheumatoid arthritis was considered to be medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2014,,,PHM,,,,,,"['Rheumatoid arthritis', 'Synovial cyst']",UNK,MERCK & CO. INC.,OT 942571,MI,,U,"congestive heart failure; rashes; shortness of breath; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 13-AUG-2012, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: rashes, shortness of breath (dyspnea), and congestive heart failure (cardiac failure congestive). The patient claimed damages as result of injury to themselves, and economic losses.The outcome of the events was not provided. Therefore, the causality for the events was related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of cardiac failure congestive was considered to be medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,08/13/2012,,,OTH,,,,,,"['Cardiac failure congestive', 'Dyspnoea', 'Rash']",UNK,MERCK & CO. INC.,OT 942578,VA,52.0,F,"Throat tightness; not feeling well; Upper chest pressure; A spontaneous report was received from a pharmacist concerning a 52-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat tightness, upper chest pressure and was not feeling well. The patient did not have any relevant medical history. The patient denied any previous history of adverse reactions to vaccines. No relevant concomitant medications were reported. On 23 Dec 2020 at 09:40 am, approximately five minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 23 Dec 2020 at 9:45 am, the patient experienced throat tightness and not feeling well. The patient was pale and hypertensive. She was carried on a stretcher and placed on oxygen. Rapid response team was called in and treatment with intravenous (iv) fluids including iv push of famotidine at a dose of 20 mg was initiated. Patient was transported to the Emergency Department (ED) for further evaluation. Additionally, the patient received iv treatment with methylprednisolone succinate at a dose 125 mg and diphenhydramine at a dose of 25 mg. Throat tightness and upper chest pressure were reported to be relieved. The patient was discharged with prescriptions for oral prednisone, famotidine, and diphenhydramine to be taken as needed for recurrent symptoms. Action taken with mRNA-1273 in response to the events of throat tightness, upper chest pressure, and not feeling well was not reported. The events, throat tightness, upper chest pressure, and not feeling well were considered resolved on an unknown date.; Reporter's Comments: This case concerns a 52-year-old, female subject who received their first of two planned doses of mRNA-1273 (Lot 039K20A), experienced the unexpected events of not feeling well; upper chest pressure and not feeling well. The onset of events occurred 5 min after the first dose of vaccine administration. The reporter causality assessment for the events was not provided. Due to the temporal association between the events and the administration of vaccine, a causal relationship cannot be excluded, and the events are assessed as possibly related to vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Chest discomfort', 'Hypertension', 'Malaise', 'Pallor', 'Throat tightness']",1,MODERNA,OT 942580,AZ,,F,"Rigidity all over; All muscles were clenched up; BP was 170; Heart rate elevated; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rigidity all over, all muscles were clenched up, BP was 170, and heart rate elevated. The patient's medical history, as provided by the reporter, was unremarkable with no history of allergies or seizures/epilepsy. No relevant concomitant medications were reported. On 28 Dec 2020, ten minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 28 Dec 2020, ten minutes after vaccination, the patient had rigidity all over and all her muscles were noted to be clenched up. There was no loss of consciousness and the patient claimed that she was still able to hear the people around her. Her blood pressure at the time was 170 and her heart rate was noted to be elevated. Her temperature was 98 degree Fahrenheit. Treatment for the event included oral diphenhydramine which caused her condition to subside. After an unspecified period of time, the rigidity recurred and the patient was taken to the emergency room. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, rigidity all over, all muscles were clenched up, BP was 170, and heart rate elevated were not reported.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted events of Muscle rigidity and Muscle tightness and the non-serious unlisted events of BP was 170 and heart rate elevated. The events occurred 10 minutes after vaccination and treatment with oral diphenhydramine was administered. Based on temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Heart rate increased', 'Muscle rigidity', 'Muscle tightness']",1,MODERNA,OT 942586,CT,51.0,F,"complete paralysis on the left side of her body and felt like it was bell's palsy; complete paralysis of the left side of her body and felt like it was bell's palsy; forearm, thumb, and pointer finger feels tingly; can't get a grip on things; Chills; headache; A spontaneous report was received from a 51-year-old, female consumer, who was also the patient, who received Moderna's COVID-19 vaccine and experienced the events, complete paralysis on the left side of her body and felt like it was bell's palsy, forearm, thumb and pointer finger feels tingly, can't get a grip on things, chills, and headache. The patient reported a history of anaphylactic shock, but had not experienced an episode in about 10 years. Concomitant product use was not reported. On 27 Dec 2020, approximately two hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27 Dec 2020, about two hours after receiving the vaccine, the patient felt chills and had a headache. The patient went to sleep and woke up to complete paralysis on the left side of her body and felt like it was bell's palsy. Since 27 Dec 2020, the patient's forearm, thumb, and pointer finger have felt tingly and she can't get a grip on things. Treatment for the events included ibuprofen. Action taken with mRNA-1273 in response to the event was unknown. The events forearm, thumb and pointer finger feels tingly and can't get a grip on things were considered not resolved. The outcome for the events, complete paralysis on the left side of her body and felt like it was bell's palsy, chills, and headache was unknown.; Reporter's Comments: This case concerns a 51-year-old, female subject with medical history of anaphylactic shock, who experienced a serious, unexpected events of hemiplegia and facial paralysis; and non-serious, unexpected events of paresthesia, motor dysfunction; and non-serious, expected events of chills and headache. The events of hemiplegia, facial paralysis, paresthesia, and motor dysfunction occurred same day of mRNA-1273 (lot # unknown) administration. The event of chills and headache occurred 2 hours after the vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Anaphylactic shock,,,"['Chills', 'Facial paralysis', 'Grip strength decreased', 'Headache', 'Hemiplegia', 'Motor dysfunction', 'Paraesthesia']",1,MODERNA,OT 942588,TN,,F,"Bell's palsy; A spontaneous report was received from a nurse, who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, within three days after vaccine administration, the reporter stated that she went to the doctor because she had problems with the whole left side of her face. The patient reported she has Bell's palsy now, she cannot smile. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event, Bell's palsy, was unknown. The reporter assessed the event, Bell's palsy, as related to mRNA-1273.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of facial paralysis. The event of facial paralysis occurred approximately 3 days after the first dose of mRNA-1273 (Lot# unknown) administration. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Facial paralysis'],1,UNKNOWN MANUFACTURER,OT 942602,NJ,53.0,M,"Headache; migraine; tenderness at injection site; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Fatigue; This is a spontaneous report from a contactable physician (patient). A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on right deltoid on 05Jan2021 07:45 at single dose for covid-19 immunization. Family history included migraine (other family members). Medical history included mild blood pressure and kidney stones, reactive airway disease. Concomitant medication included colecalciferol (VITAMIN D), potassium, allopurinol and hydrochlorothiazide/valsartan for mild blood pressure and kidney stones, fluticasone propionate, salmeterol xinafoate (ADVAIR) for reactive airway disease, atorvastatin, and multivitamins. The patient previously took fluticasone propionate, salmeterol xinafoate (ADVAIR) and experienced dry mouth and lost sense of taste. The patient also previously took Tdap booster on Aug2020, Shingrix on 10Aug2020, and influenza on 12Oct2020; all for immunization; and tetanus injections for immunization and experienced localized tenderness. The patient had the first dose of BNT162B2 (lot number: EH9899) for COVID-19 immunization on 15Dec2020 and experienced localized tenderness at injection point. The received his second dose of COVID vaccine on 05Jan2021. With the first dose he had increased localized tenderness at injection site on 15Dec2020, and he rated it mild to moderate. He would say it was 80% resolved in 24 hours. It had completely resolved in 36 hours. He would say that he has recovered completely form the localized tenderness with the first dose. Then he noted his second dose was yesterday, in the context of not having much sleep the night before. The actual injection was uncommonly eerily painless. The other folks in his department had similar experience. Maybe it was the nurse who gave the injection. Maybe it was because it was the same area and sensitivity was decreased. They had to check the Band-Aid to make sure blood was there. The administration was painless. He was relieved when the arm started getting sore to know he actually received it. He had increased arm tenderness at injection site which he rated as moderate which has now resolved. It got to moderate where lifting the arm up was sore. He definitely knew that he had been vaccinated. He got the vaccine at 7:45AM and now it is 16 to 17 hours later and he would say the pain is mild now. It did persist. The first vaccine hurt a little more. He expects this to go away. Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias. He had unrelenting headache over night that was moderate to severe. He said it kept him awake. It was exacerbated by lying down. Sitting up helped him. It became a migraine which is something he doesn't often experience. Migraines are pretty rare for him. He took 800mg of Advil at 6AM that helped for headache and migraine. The weight of the patient was 250 to 255 pounds. Shaking, sweats, hot and cold flashes, and augmentation of myalgias have resolved. Everything has resolved except for a little headache. In the background he literally had one or two hours of sleep. He thinks that likely precipitated a migraine was increased. Last night he slept literally an hour. He took 800mg of Advil and fell asleep. He is operating on 2 hours of sleep in 48 hours. Most of the stuff is gone except a little headache and expected fatigue. Headache Seriousness Criteria: he would say that it was relatively disabling. He would not have been able to carry on. He wouldn't have been able to operate last night. It would have interfered. It was dissimilar to others. He gets rare migraines. Everything was amplified with a migraine. He certainly felt that. It was fair to say the vaccine precipitated the migraine that was mild or severe. He doesn't want to falsely attribute these things to the vaccine. Causality Headache: precipitated by the vaccine. In the context that he had not slept the night before. He had a nasopharyngeal COVID test and it was negative. He has been in a COVID study where they are looking at combination. They developed a saliva test at (Name). There is a combination of saliva oropharyngeal and immunoglobins. He has been negative multiple times. The outcome of the events headache and fatigue was not recovered and recovered for the rest of the events.; Sender's Comments: A causal association between BNT162B2 and the reported event headache cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/05/2021,01/01/2021,,PVT,VITAMIN D [COLECALCIFEROL]; ; ; VALSARTAN & HCTZ; ADVAIR;,,Medical History/Concurrent Conditions: Airways obstruction; Blood pressure abnormal; Kidney stone; Migraine (he has other family members with history of migraines.),,,"['Condition aggravated', 'Fatigue', 'Feeling of body temperature change', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Migraine', 'Myalgia', 'Pain', 'Pain in extremity', 'SARS-CoV-2 test negative', 'Sleep disorder', 'Tremor']",2,PFIZER\BIONTECH, 942611,NJ,52.0,M,"A PCR test was done and received results Monday (4th) as positive; A PCR test was done and received results Monday (4th) as positive; Had some scratchy throat late friday night; Saturday called out sick to work as the cough started; Saturday called out sick to work as the cough started.; Lost taste and smell monday; Lost taste and smell monday; Running fever; fatigue; This is a spontaneous report from a contactable Pharmacist (the patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1686, expiration date unknown) via an unspecified route of administration on 28Dec2020 at 12:00 PM (at the age of 52-years-old) via an unspecified route of administration at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included hypertension, high blood cholesterol from unknown dates. Allergy information was not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was administered the vaccine at a Nursing Home/Senior Living Facility. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN/HYDROCHLOROTHIAZIDE), atorvastatin (LIPITOR), fenofibric acid (FENOFIBRIC ACID), amlodipine besilate (NORVASC). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received the vaccine on Monday 28Dec2020. A PCR test for COVID was done on Tuesday and a rapid test on Wednesday both of which were negative. The patient experienced some scratchy throat late Friday night on Saturday, 02Jan2021 the patient called out sick to work as a cough had started. A PCR test was done on 02Jan2021 and he received results Monday (4th) as positive. The patient continued to say that the cough had subsided, as he took Delsym. He lost taste and smell on Monday. He reports running a fever that varies from 99-101.5. He took Tylenol and Motrin to control the fever. In addition he has experienced fatigue. It was also reported, in contradiction of the above reported chronology of events, that the onset date of events was 25Dec2020 (CONFIRMATION PENDING for onset date of events relative to vaccine administration). The patient experiences of COVID 19 positive test, scratchy throat, sickness, cough, loss of test and smell, fever and fatigue resulted in a physician office visit (date not specified). The patient underwent lab tests that includes a PCR test on 29Dec2020 which was negative, a rapid test on 30Dec2020 which was negative and a PCR test on 02Jan2021 which was positive. Treatment for the events was reported as Motrin and Tylenol for fever and Delsym. for cough. The clinical outcome of COVID 19 positive test, scratchy throat, sickness, cough, loss of test and smell, fever and fatigue was reported as not recovered.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 28Dec2020, and COVID-19 PCR test positive on 02Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,,,OTH,VALSARTAN/HYDROCHLOROTHIAZIDE; LIPITOR; ; NORVASC,,Medical History/Concurrent Conditions: Blood pressure high; Cholesterol,,,"['Ageusia', 'Anosmia', 'Cough', 'Fatigue', 'Illness', 'Impaired work ability', 'Pyrexia', 'SARS-CoV-2 test positive', 'Throat irritation']",1,PFIZER\BIONTECH, 942619,FL,40.0,M,"he tested positive for COVID-19 / (probably infected by a family member); runny nose; dry cough; flu-like symptoms; he tested positive for COVID-19 / (probably infected by a family member); he tested positive for COVID-19 / (probably infected by a family member); This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient stated that the next dose is scheduled for the time of the report, however he tested positive for COVID-19 on 05Jan2021 (probably infected by a family member). Representatives at the administration site are not sure if he should get the second dose. The patient reported minor symptoms ""flu-like symptoms, runny nose, dry cough, no major symptoms"". The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,01/05/2021,19.0,UNK,,,,,,"['Cough', 'Exposure to SARS-CoV-2', 'Influenza like illness', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 942620,,27.0,M,"diagnosed with covid 30Dec2020; diagnosed with covid 30dec2020; This is a spontaneous report from a contactable nurse (patient). A 27-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EK5730), via an unspecified route of administration in right deltoid on 21Dec2020 13:45 at single dose for Vaccination. There were no medical history and concomitant medications. The patient was diagnosed with covid on 30Dec2020 with outcome of recovering. The patient underwent lab tests and procedures which included COVID test: positive on 30Dec2020. The patient received the first dose of the covid vaccine on 21Dec2020, and was diagnosed with covid on 30Dec2020. The patient had COVID test on 30Dec2020 and received positive result of COVID test on 31Dec2020. He was scheduled for the second dose between 08Jan2021 and 11Jan2021. He asked if he should continue to get the second dose as scheduled in relation to the diagnosis of COVID. COVID: the patient still had chest congestion, but no fever without medication, no cough anymore. He was having cough, fever, loss of taste and smell, fatigue and malaise. Reporter seriousness for COVID: Not serious. Relatedness of drug to reaction/event: Reaction assessed: COVID, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Unrelated. Verbatim event relatedness: Pfizer COVID-19 Vaccine: COVID-Unrelated.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 21Dec2020, and was diagnosed with COVID-19 on 30Dec2020. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the diagnosed COVID-19 likely represents the pre-existing infection prior to vaccine use, and unrelated to BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/30/2020,9.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Ageusia', 'Anosmia', 'COVID-19', 'Cough', 'Fatigue', 'Malaise', 'Pyrexia', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 942621,OK,,F,"she got Covid; she got Covid; This is a spontaneous report from a contactable physician. A female patient (Patient Age: 18; Unit: Unspecified) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date t a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse that her first Pfizer Covid 19 vaccine and a couple of days later developed symptoms of Covid and tested positive. Stated that she recovered and had no symptoms. Information on Lot/Batch number has been requested.; Sender's Comments: The reported symptoms of Covid with tested positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 942623,IN,38.0,M,"covid test result=Positive; covid test result=Positive; This is a spontaneous report from a contactable other healthcare professional (other HCP reporting for himself). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. and expiry date unknown), via an unspecified route of administration on 16Dec2020 12:45 (1st dose) at a single dose on his left arm for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included hydrochlorothiazide, losartan potassium (HYZAAR), omeprazole, and ibuprofen; all on unspecified dates for unspecified indications. The patient previously took amoxicillin and experienced allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, he was also not diagnosed with COVID-19 prior to vaccination. However, since the medication, the patient has been tested positive for COVID-19. Patient had his nasal swab on 22Dec2020, and it turned out positive (COVID test result=positive). Outcome of the event drug ineffective and COVID-19 virus test positive was unknown. Facility where the most recent COVID-19 vaccine was administered at the hospital. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/22/2020,6.0,PVT,HYZAAR; ;,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 942624,TX,37.0,F,"covid test result=Positive; covid test result=Positive; nasal congestion; sneezing runny nose; sneezing runny nose; sinus pressure; dry cough; This is a spontaneous report from a contactable Nurse (patient herself). This 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140), via an unknown route, on 19Dec2020 at 16:15 at single dose for COVID-19 immunisation. Vaccine location was arm left. The patient was not pregnant. The patient was vaccinated at hospital, age at vaccination was 37-year-old. No other vaccine was received in four weeks. No relevant medical history was provided. Relevant concomitant medications included amoxicillin sodium, clavulanate potassium (AUGMENTIN, formulation: tablet) at dose of 875 mg twice daily from an unknown. Pre-vaccination COVID test was not performed. On 25Dec2020 at 20:00, the patient complained of nasal congestion, sneezing runny nose, sinus pressure, and cough. On 28Dec2020, COVID test Nasal Swab (SOFIA SARS ANTIGEN FIA/QUIDEL) was performed and resulted positive. She was given oral azithromycin 500 mg 1 tab Daily and oral benzonatate (TESSALON PERLES) 1 Capsule three times a day (TID). The symptoms of nasal congestion, sneezing runny nose, sinus pressure, and cough were improving. The outcome of 'COVID test result=Positive' was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and SARS-CoV-2 test positive cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/25/2020,6.0,PVT,AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM],,,,,"['Cough', 'Nasal congestion', 'Paranasal sinus discomfort', 'Rhinorrhoea', 'SARS-CoV-2 test positive', 'Sneezing']",1,PFIZER\BIONTECH, 942626,NY,,U,"two staff members who tested positive for covid after receiving the first dose.; two staff members who tested positive for covid after receiving the first dose.; This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist reported similar events for 2 patients. This is a first of two reports. A staff member of unknown age and gender received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were unknown. The reporter stated that have a staff member took the first shot and afterward got a positive COVID test. He is asking about the recommendation regarding taking the second shot. The reporter explained he is the immunizer and 2.5 weeks ago he gave the employ at the facility the first does of the vaccine. He has very little information to provide on this event. He called to go over the procedure for administering the second dose and that is when in was inform. Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and SARS-CoV-2 test positive cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021011912 Same reporter/ drug/ event for different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 942627,,,F,"received first dose of the vaccine on 19Dec and tested positive on 30Dec; received first dose of the vaccine on 19Dec and tested positive on 30Dec; This is a spontaneous report from a contactable nurse reported for herself. A female patient on unknown age received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not provided. On 30Dec2020 the patient experienced tested positive for COVID-19. It was reported that the patient is scheduled to have her 2nd dose on 09Jan2021however she's been getting roundabout information on what to do in her case. Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and SARS-CoV-2 test positive cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/30/2020,11.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 942628,AL,,F,"She tested positive to COVID on 29DEC2020; She tested positive to COVID on 29DEC2020; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, lot no. and expiry date were unknown), via an unspecified route of administration on 21Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive to COVID on 29Dec2020. She received the 1st dose of the vaccine on 21Dec2020. She is due for the 2nd dose on 11Jan2020. They asked if she should still receive the 2nd dose. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 Nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/29/2020,8.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 942629,NY,36.0,F,"got the covid 19 vaccine on 21Dec2020 and tested positive for covid on 24Dec2020; got the covid 19 vaccine on 21Dec2020 and tested positive for covid on 24Dec2020; This is a spontaneous report from a contactable Nurse (patient) from a Pfizer-sponsored program Pfizer First Connect. A 36-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730), via intramuscular in left deltoid on 21Dec2020 10:00 at 0.3 ml, single for precaution as front line healthcare worker in hospital which is not a military facility. Medical history included nonsmoker. She did not provide causality but stated that she probably already had COVID when she got the vaccine. It was unknown if the patient had SARS-CoV2 antibodies at diagnosis as she had never been tested. Other history was none. The patient did not have a history of hypertension, diabetes, heart disease, lung disease, liver disease, kidney disease, cancer, immunosuppressive disorder, obesity. There was not any pre-existing diseases worsened during the SARS-CoV2 infection. The patient hadn't been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. Concomitant medication included bupropion hydrochloride (WELLBUTRIN SR), sertraline hydrochloride (ZOLOFT), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Prior Vaccinations (within 4 weeks) were none. AE following prior vaccinations were none. There was no additional vaccines administered on Same Date (21Dec2020) of the Pfizer bnt162b2. The patient got the covid 19 vaccine on 21Dec2020 and tested positive for covid on 24Dec2020. The patient wanted guidance on receiving the 2nd dose of the vaccine. The reporter considered event was non-serious. The patient received the first dose of the vaccine on 21Dec2020, and after that on 24Dec2020, she tested positive for COVID . She was supposed to be revaccinated on 07Jan2021. She would like to know if she should she get this or does she need to be revaccinated. There is no prescriber. She received it through her work. She received the first dose on 21Dec2020, and assumed she was positive when she got it. She just had cough and muscle aches and a headache. Her dad was hospitalized. Hers was not that serious. She had not completely recovered yet. Her smell had not come back yet and she was just tired still. She said the headache was prior to getting vaccine. She did not provide causality but stated that she probably already had COVID when she got the vaccine. The cough occurred on 25Dec2020, muscle aches on 22Dec2020 at 08:00. There was no emergency room of or physician's office required for the events. The patient was not hospitalized or admitted to an ICU. Nasal swab test done. Imaging for COVID-Pneumonia, other radiological investigations, hematology, clinical chemistry, inflammatory markers, urinalysis, evidence of hypoxemia, other relevant test were none. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient did not receive any additional therapies for COVID-19. The event did not require the initiation of new medication or other treatment or procedure. She did start taking extra vitamins on her own. The patient was recovered with some lasting effects such as not being able to smell and is tired still.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID with symptoms and the administration of COVID 19 vaccine, bnt162b2. However, as the reporter claimed ""she probably already had COVID when she got the vaccine"", this may provide an alternative explanation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/24/2020,3.0,PVT,WELLBUTRIN SR; ZOLOFT; ADDERALL,Suspected COVID-19 (probably already had COVID when she got the vaccine),Medical History/Concurrent Conditions: Hospitalization (Her dad); Nonsmoker,,,"['Anosmia', 'Cough', 'Fatigue', 'Myalgia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 942633,,,M,"had the first dose of the COVID-19 vaccine last 24Dec2020 and the second dose is scheduled on 14Jan2021/tested positive for COVID-19; had the first dose of the COVID-19 vaccine last 24Dec2020 and the second dose is scheduled on 14Jan2021/tested positive for COVID-19; This is a spontaneous report from a contactable Nurse (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the first dose of the COVID-19 vaccine last 24Dec2020 and the second dose is scheduled on 14Jan2021. However, last 04Jan2021, the patient tested positive for COVID-19. The patient was looking for recommendations on when he/she can take the COVID-19 vaccine. The patient underwent lab tests and procedures which included COVID-19 test: positive on 04Jan2021. The outcome of the event was unknown. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,01/04/2021,11.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 942635,CA,37.0,F,"Received the vaccine on 23Dec2020. She tested positive for COVID on 31Dec2020.; Received the vaccine on 23Dec2020. She tested positive for COVID on 31Dec2020.; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable other healthcare professional (patient herself) reported that a 37-year-old female patient received bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899), via an unspecified route of administration in the left arm 23Dec2020 at single dose, for Covid-19 immunization. Medical history included migraine (takes a migraine medication). Her height was 168cm, weight of 72.5kg. There were no concomitant medications. Received the vaccine on 23Dec2020. She tested positive for COVID on 31Dec2020. Then she had another test and was negative for COVID on 03Jan2021 and was also negative for another test on 05Jan2021. She was wondering if this was like a super vaccine and knocked it out or if there was an error with the test. She acknowledged that there was a lag time for the second dose of 21 days. She was wondering if there was a grace period for that since she cannot be cleared for work. She was also wondering what to do before her second dose of the vaccine. The outcome of event was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported positive Sars-Cov-2 test, which is considered ineffective of BNT162B2, and the administration of BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/31/2020,8.0,UNK,,,Medical History/Concurrent Conditions: Migraine,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 942637,CA,,F,"she tested positive for the Covid-19; she tested positive for the Covid-19; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date were unknown), via an unspecified route of administration on 17Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Covid-19 vaccine on 17Dec2020. She said that she tested positive for the Covid-19 after that (unspecified date) and she is due to get her second dose of the vaccine today 07Jan2021. She said that she is wondering if she needs to get the second dose. The outcome of the event was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported event.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 942639,,43.0,F,"tested positive for COVID; tested positive for COVID; This is a spontaneous report from a non-contactable nurse (patient) and a contactable consumer. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID Prevention because of occupation. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for COVID on 02Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID test: positive on 02Jan2021. The patient got the first dose of the COVID vaccine, and then tested positive for COVID afterward. The patient was inquiring about if there are any recommendations for getting the second dose, if the person tested positive for COVID after getting the first dose. The patient did not provide prescriber information. The patient should come off of quarantine on 15Jan2021. It was unknow if the patient received any other vaccines on the same day as the COVID vaccine and if there were any concomitant medications, history or investigations other than the COVID test. The type of COVID test the patient received was unknown, just that she got the positive result on 02Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/02/2021,10.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 942641,CA,22.0,M,"He is losing some taste/but reduced by 30-40%; received first dose of vaccine 21DEC2020 and SARS-Cov-2 positive/Nasal swab COVID positive; received first dose of vaccine 21DEC2020 and SARS-Cov-2 positive/Nasal swab COVID positive; Sniffles; This is a spontaneous report received from Pfizer sponsored program Pfizer First Connect via a contactable other HCP (parent) reported for the patient (son). A 22-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EK5730) intramuscularly in left arm on 21Dec2020 (15:00-16:00) at single dose for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient received first dose of vaccine 21Dec2020 and SARS-Cov-2 positive 06Jan2021 13:00. The patient got COVID vaccine 21Dec2020, and was scheduled to get second dose on 11Jan2021. He had a sniffle the other day on 05Jan2021 night time and tested positive for COVID on 06Jan2021, so reporter wanted to know if he should still get second dose. His symptoms are stable. He is quarantining. He is on his way to do a PCR now. Reporter read somewhere people could have false positive in nasal. He is losing some taste from 07Jan2021 (01:00 - 02:00). Most things he can taste. Some he cannot. It is not completely gone but reduced by 30-40%. He did a mouthwash with a sting and is not feeling that sting anymore. He said last night, same thing. He did a mouth wash and did not really taste much. It is not as prevalent as it was before. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 06Jan2021, positive COVID test 06Jan2021, 13:00, Nasal swab COVID. Event outcome of sniffles was recovering, while for other events was unknown.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported event ___ cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,01/05/2021,15.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Hypogeusia', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 942645,,,F,"an employee who received the first dose of the Covid 19 vaccine, has tested positive for Covid 19 today; an employee who received the first dose of the Covid 19 vaccine, has tested positive for Covid 19 today; This is a spontaneous report from a contactable other HCP and a nurse. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient employee who received the first dose of the COVID 19 vaccine, has tested positive for COVID 19 today, 07Jan2021. The outcome of the event was unknown. The reporter would like to know if the patient can get the second COVID-19 vaccine. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported event.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/07/2021,,PVT,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 942657,VA,26.0,F,"Tested positive for COVID after receiving the first dose of the vaccine; Tested positive for COVID after receiving the first dose of the vaccine; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ-685, expiration date: Mar2021), via an unspecified route of administration in the right arm on 21Dec2020 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient tested positive for COVID on 26Dec2020. Now, she is wanting to know if she should still get the second dose. Outcome of the events was unknown.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 21Dec2020, and COVID-19 test positive on 26Dec2020. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/26/2020,5.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 942658,CA,39.0,F,"tested positive/had the COVID infection/cough; tested positive/had the COVID infection/cough; PFIZER-BIONTECH COVID-19 VACCINE at 1.3 mL; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 19Dec2020 at 1.3 mL, single for COVID-19 immunization. There were no medical history and concomitant medications. She received the first COVID-19 vaccine dose on 19Dec2020 then she tested positive on 22Dec2020. She got the first dose of the COVID vaccine and now she had the COVID infection. She was wondering if she should continue to get the second dose. She was also wondering if it will affect whether or not she gets the second dose. She couldn't find information online about what to do. Before she got the vaccine, she did take a test on an unspecified date to make sure she was negative, and she was. She had a cough at the end of the call. Outcome of the events was unknown. Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/19/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'Cough', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 942659,WI,34.0,F,"Idiopathic trigeminal neuralgia; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), intramuscular (right deltoid) first dose on 21Dec2020 at single dose for Covid-19 immunization. The patient's medical history included multiple sclerosis from 2015 (Diagnosed 5 year) and ear infection from 03Dec2020 prior to vaccination, she was seen in urgent care with an ear infection, states it was super painful and lasted about 7-10 days treated it with drops.. There were no concomitant medications. The patient requested guidance on whether or not she should get the second dose of the covid vaccine after being diagnosed with Trigeminal Neuralgia following the first dose. The patient stated that she received the first done on 21Dec2020 and on 27Dec2020 was diagnosed with Idiopathic trigeminal neuralgia. The patient was unclear if the vaccine played a part in the diagnosis and wonders if there is any data available about this as an adverse event as she read that Bells Palsy was reported and this was similar. The patient need guidance on whether to get second dose of the Covid vaccine scheduled for on Monday. Wondering if getting the second dose would be risking it flaring up, states she was now on anticonvulsant medication and gabapentin and they have increased the anticonvulsant medication. The patient experienced idiopathic trigeminal neuralgia (trigeminal neuralgia) (non-serious) on 27Dec2020 with outcome of not recovered. The action taken in response to the event(s) for bnt162b2 was not applicable. The outcome of the event was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Trigeminal Neuralgia due to temporal relationship. However, the event may possibly represent concurrent medical condition in this patient with medical history of multiple sclerosis. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and viral serologies, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/27/2020,6.0,UNK,,,Medical History/Concurrent Conditions: Ear infection; Multiple sclerosis,,,['Trigeminal neuralgia'],1,PFIZER\BIONTECH,OT 942717,NC,39.0,F,"rash developed on 50% of her body; vomiting; nausea; headache; severe muscle aches; This is a spontaneous report from a contactable nurse reported for herself. This 39-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via Intramuscular at left arm on 16Dec2020 at 01:00 PM at single dose (lot number: EK5730) for COVID-19 immunisation. Medical history was unknown. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), zolpidem tartrate (AMBIEN) and vitamins. The patient previously took dicycloverine hydrochloride (BENTYL), amlodipine and azithromycin (ZITHROMAX), all experiencing allergies. The patient experienced rash developed on 50% of her body, vomiting, nausea, headache, severe muscle aches 24 hours post vaccination on 17Dec2020 10:45 AM. The patient was treated with Benadryl, Tylenol, IM Solumedrol. The patient had Covid test post vaccination by Nasal Swab on 28Dec2020 and on 04Jan2021, both with negative results. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of all events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the rash and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/17/2020,1.0,PVT,WELLBUTRIN; AMBIEN,,,,,"['Headache', 'Myalgia', 'Nausea', 'Rash', 'SARS-CoV-2 test negative', 'Vomiting']",1,PFIZER\BIONTECH,OT 942728,AR,61.0,M,"COVID-19 virus test positive; COVID-19 virus test positive; Headache; Sinus congestion; This is a spontaneous report from a contactable consumer reported for himself. A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9899 and expiration date unknown), via intramuscular on left arm on 22Dec2020 at single dose for COVID-19 prophylaxis. The patient medical history reported as none. Concomitant medications reported as none. The patient is a radiology technician that reported that he got the Pfizer vaccine on the 22Dec2020. He said that he got a positive Covid test on 04Jan2021. The patient had the Covid symptoms as of last Monday night on 04Jan2021. He stated that he developed a headaches and sinus congestion on the 04Jan2021. Stated that he has not had a fever. He said that there was no adverse reaction from the vaccine itself. He said that he was due for the second dose on the 11Jan2021 and he is currently quarantined so he will not be getting the second dose. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,01/04/2021,13.0,PVT,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No",,,"['Headache', 'SARS-CoV-2 test positive', 'Sinus congestion']",1,PFIZER\BIONTECH,OT 942730,NY,,U,"two staff members who tested positive for covid after receiving the first dose.; two staff members who tested positive for covid after receiving the first dose.; This is a spontaneous report from the Pfizer Sponsored Program called 'Pfizer First Connect' received by a contactable pharmacist. This pharmacist reported similar events for 2 staff members. This is 2nd of 2 reports. A patient (demographics unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, in Dec2020 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On unknown date, after first shot of vaccine, COVID test resulted positive. The reporting pharmacist is asking about the recommendation regarding taking the second shot. The outcome of the event was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded. ,Linked Report(s) : US-PFIZER INC-2021010495 Same reporter/ drug/ event for different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 942790,NC,,F,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; The patient had MS and was immune compromised; The patient had MS and was immune compromised; This is a spontaneous report from a contactable consumer (patient). This female consumer of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021, for COVID-19 immunization. She had MS and was immune compromised. Concomitant medications were not reported. On 07Jan2021 the patient woke up with headache, runny nose, groggy and muscle aches. She went to pharmacy and got a rapid COVID test that resulted positive. She was asking if the 1st dose could have caused her to be positive on the test. Events outcome was unknown. Information on the batch/lot number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,UNK,,Immunocompromised; MS,,,,"['Headache', 'Myalgia', 'Rhinorrhoea', 'SARS-CoV-2 test positive', 'Somnolence']",1,PFIZER\BIONTECH, 942792,,,F,"tested COVID Positive; tested COVID Positive; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tested COVID positive on 01Jan2021. She still has a few symptoms and is scheduled for the 2nd dose on 12Jan2020 or 13Jan2020. She was asking if there were any recommendations on the scheduling of the vaccine for her. The outcome of event was unknown. information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,01/01/2021,10.0,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 942808,MI,41.0,F,"severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; This is a spontaneous report from a contactable nurse (reporting for herself). A 41-year-old non-pregnant female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), both via an unspecified route of administration in the left arm, the first dose on 16Dec2020 09:00 (lot number: EH9899) and the second dose on 08Jan2021 07:15 (lot number: EL0140), both at a single dose for COVID-19 immunization. Medical history included ongoing anxiety, from an unspecified date. The patient had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), acetaminophen (MANUFACTURER UNKNOWN), naproxen sodium (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. On 09Jan2021 at 01:30 AM, the patient experienced severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath, all of which were reported as being life-threatening. The patient went to the Emergency room due to the events. Therapeutic measures were taken as a result of the events and included: methylprednisolone sodium succinate (SOLUMEDROL) 125 mg, famotidine (MANUFACTURER UNKNOWN) 20 mg and diphenhydramine hydrochloride (BENADRYL) 50 mg. The clinical outcome of severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,LEXAPRO; ACETAMINOPHEN; ;,Anxiety,,,,"['Angioedema', 'Chest discomfort', 'Dyspnoea', 'Hypertension', 'Pruritus', 'Tachycardia', 'Urticaria']",2,PFIZER\BIONTECH, 942852,,,U,the person who took the 1st dose of the vaccine and still tested positive; the person who took the 1st dose of the vaccine and still tested positive; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A non-contactable consumer reported that a patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. ~The patient took the 1st dose of the vaccine and still tested positive on unspecified date. They would like to know if the patient still needs to take the 2nd dose of the vaccine or not. No follow-up attempts are possible; information about lot/batch number cannot be obtained.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 942869,MA,,F,"Alterations in her mouth that seemed Bell�s Palsy; Not sure whether patient has Bell�s Palsy or shingles; This case was reported by a physician via call center representative and described the occurrence of bell's palsy in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 25th November 2020, the patient received the 1st dose of Shingrix. On 4th December 2020, 9 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the bell's palsy and shingles were unknown. It was unknown if the reporter considered the bell's palsy and shingles to be related to Shingrix. Additional information was provided as follows: The age at vaccination was not reported, however it could be 75 or 76 years old. On 4th December 2020, the patient experienced little alterations in her mouth that seemed Bell�s Palsy. Her VZV (Varicella zoster virus) IgM antibodies levels were measured 4 weeks after vaccination and they had increased. The reporter was not sure whether patient had Bell�s palsy or shingles. The reporter was reticent to provide details but agreed to follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,11/25/2020,12/04/2020,9.0,UNK,,,,,,"['Blood immunoglobulin G increased', 'Dyskinesia', 'Facial paralysis']",1,GLAXOSMITHKLINE BIOLOGICALS, 942895,HI,83.0,M,"Patient states that the vaccine administered to his left arm worsened his left arm weakness. He had surgery as listed earlier on 12/2/2020, he then mentioned to multiple healthcare providers on 12/21/2020 that he could not lift his left arm past his nipple line. He was then started on dexamethasone for three days. The vaccine was then given on 12/24/2020 to the left deltoid. Of note, PPSV23 was given to his right arm that day as well. The patient then states that a few days later and according to our documentation (1/2/21) he could no longer lift his left arm past his navel. He has been getting occupational/physical therapy with minimal to no improvement.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/24/2020,12/26/2020,2.0,OTH,"levocetirizine, astaxanthin, turmeric, furosemide, hydrocodone/acetaminophen, bioastin, ipratropium nasal spray, lidocaine patch, levothyroxine, cyclobenzaprine, bisacodyl suppository, senna/docusate, krill oil, tamsulosin, allopurinol, fam","cervical stenosis (had C3-C6 laminectomy and fusion on 12/2/2020) actually had new left arm weakness starting 12/21/2020, which is prior to injection, heart failure with current exacerbation","CKD3, BPH, depression, insomnia, orthostatic hypotension",,"lactose, starceptic brand soap","['Condition aggravated', 'Mobility decreased', 'Muscular weakness', 'Vaccination site movement impairment']",1,GLAXOSMITHKLINE BIOLOGICALS,IM 942897,PA,80.0,M,"History of Present Illness: � Patient is a 80 y.o. male who presents with chest pain. Patient reported that he 1st had the chest pain approximately 2 weeks ago when he woke from sleep. At that time patient pain lasted about 5 minutes or so and resolved when he got out of bed. He did well for the rest of the day up until yesterday. Patient reported that yesterday morning he woke up with the pain at the lasted about 30 minutes or so. Patient also had associated burping felt that it is likely GI in nature. The pain was located mainly in the left side of the chest without any radiation. No diaphoresis. No shortness of breath or palpitation. No radiation for the pain. Since yesterday morning he had another 3 episodes of pain the last after dinner tonight. Patient reported that this pain was located more on the left side of the chest, likely lasted about 10 minutes or so. There was no exertional component to the pain. No known history of heart disease. Due to rather recurrent nature of the pain patient was brought to the hospital by his son who is a cardiologist to be evaluated. No fever or chills. No cough . Patient reported that he got vaccination for COVID 2 days ago-of a concern that this may be a side effect of the vaccine. No dizziness lightheadedness. Patient with history of GI bleed in the past at that time patient was on NSAIDs. Patient with burping associated with the pain",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/29/2020,01/01/2021,3.0,PVT,"Medication List As of 12/29/2020 �4:07 PM ALPRAZolam 1 mg Oral Daily at bedtime Atorvastatin Calcium 10 mg Oral Once at bedtime (Medrol Dose Pack ONLY) Celecoxib 200 mg TAKE ONE CAPSULE BY MOUTH EVERY DAY Gabapentin 300 mg Caps, TAKE",n.a.,Past Medical History: Diagnosis Date ? Anxiety � ? Arthritis � ? Asthma � ? Chronic back pain � ? COPD (chronic obstructive pulmonary disease) (HCC) � ? Elevated PSA � ? Gastrointestinal hemorrhage � ? Hypercholesteremia � ? Hypertension � ? Insomnia � ? Leg weakness � � b/l ? Lumbar disc disease � ? Migraines � ? OA (osteoarthritis) � ? Seasonal allergies,,"Nsaids High GI Bleeding Long term NSAID use, 30 years for back pain/migraines. Experienced GI bleed in 2013, no longer takes NSAIDS Vicodin [hydrocodone-acetaminophen] Medium GI Intolerance NAUSEA/VOMITING","['Bundle branch block right', 'Chest pain', 'Electrocardiogram abnormal', 'Eructation', 'Gastrointestinal disorder', 'Troponin I normal']",1,MODERNA,IM 942904,PA,50.0,M,"Chief Complaint Patient presents with ? Generalized Body Aches � � Pt presents via EMS c/o DOE, dry non-productive cough, subjective fevers Tmax 101.9, decreased appetite, aches since testing + for COVID on 1/5. � Patient is a 50 year old male with PMH of Crohns/MS on fingolimod presenting to the Hospital for fevers, shortness of breath and weakness. Patient received COVID vaccine on 12/29. Patient had initial left arm discomfort though has had worsening weakness, cough, shortness of breath and fevers since that time. Patient tested positive for COVID19 on Patient has shortness of breath with exertion that is relieved by rest. Patient denies N/V/D. Patient has taken tylenol at home to attempt to alleviate symptoms.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,12/29/2020,01/09/2021,11.0,PVT,"cholecalciferol (VITAMIN D3) 1,000 units tablet fingolimod (Gilenya) 0.5 MG capsule gabapentin (NEURONTIN) 100 mg capsule ibuprofen (MOTRIN) 600 mg tablet vitamin B-12 (VITAMIN B-12) 1,000 mcg tablet",n.a.,Crohn's disease (HCC) ? Migraine � ? Multiple sclerosis (HCC) 2010 ? Vitamin D deficiency,,Keflex [Cephalexin,"['Asthenia', 'C-reactive protein increased', 'COVID-19 pneumonia', 'Chest X-ray abnormal', 'Cough', 'Decreased appetite', 'Dyspnoea', 'Dyspnoea exertional', 'Electrocardiogram QRS complex abnormal', 'Electrocardiogram abnormal', 'Hypopnoea', 'Limb discomfort', 'Lung opacity', 'Myocardial infarction', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive', 'Serum ferritin increased']",1,MODERNA,IM 942909,PA,68.0,M,"Chief Complaint Patient presents with ? Vomiting � � pt reports dry heaving and nausea that started an hour ago � Patient is an 68 y.o. year old male with PMHx significant for HTN, BPH, who presents to the ED today with nausea and dry heaving for one hour PTA. States that he was at work as a courier when he had onset of sensation of room spinning, nausea, and dry heaving. Also having tinnitus which he thinks is b/l. This happened once about two weeks ago and resolved spontaneously overnight when he was asleep. No preceding illnesses, medication changes, or other associated symptoms. Vertigo has no clear exacerbating or relieving factors. Has not yet taken anything for symptoms. � The patient denies fevers, chills, headaches, syncope, chest pain, shortness of breath, rhinorrhea, sore throat, cough, abdominal pain, changes in usual bowel movements, changes with urination, back pain, pain anywhere else in body. The patient has no sick contacts, recent travel history.",Not Reported,,Not Reported,Yes,,Not Reported,U,12/28/2020,01/12/2021,15.0,PVT,Medication List As of 12/28/2020 �9:21 AM Lisinopril 20 mg Oral Daily Sildenafil Citrate 20 mg Take 3-5 tablets PO PRN erectile dysfunction Tamsulosin HCl 0.4 mg Oral Daily with dinner,n.a,Benign hypertension Elevated PSA Elevated LDL cholesterol level,,n.a,"['Angiogram cerebral normal', 'Arteriogram carotid abnormal', 'Carotid arteriosclerosis', 'Cerebral microangiopathy', 'Magnetic resonance imaging brain abnormal', 'Nausea', 'Retching', 'Scan with contrast abnormal', 'Tinnitus', 'Vertigo', 'Vomiting']",1,MODERNA,IM 942914,PA,50.0,F,HOSPITAL COURSE: Patient is a 50 y.o. female with a history of anxiety and migraine headaches who presented to hospital with cough and diarrhea. The patient had felt the symptoms on 12/31/2020 and eventually went to have a COVID test on 1/1/2021. She was subsequently positive but due to dehydration and diarrhea she came to the emergency department where she was admitted for remdesivir and dexamethasone. She was able to be weaned off any supplemental oxygen. Her diarrhea resolved. She is feeling well and will be discharged home in good condition.,Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,12/23/2020,01/03/2021,11.0,PVT,Medication List As of 12/23/2020 10:38 AM Albuterol Sulfate 90 mcg/act 2 puffs Inhalation Every 4 hours PRN ALPRAZolam 0.25 mg Oral Daily PRN Butalbital-APAP-Caffeine 50-325-40 mg 1 tablet Oral Daily PRN FLUoxetine HCl 20 mg Oral Daily,"Nausea, Body aches","Digestive Esophageal reflux IBS (irritable bowel syndrome) Respiratory Asthma Cardiovascular and Mediastinum Essential (primary) hypertension Migraine, unspecified, not intractable, without status migrainosus Nervous and Auditory Carpal tunnel syndrome Cubital tunnel syndrome Decreased hearing of left ear Dysfunction of both eustachian tubes Wartenberg syndrome Musculoskeletal and Integument Bunion, right foot Folliculitis Biceps tendonitis on left Calcific tendonitis of left shoulder Lateral epicondylitis of left elbow Genitourinary Chronic interstitial cystitis Other MDD (major depressive disorder), recurrent severe, without psychosis (HCC) Acute pain of left knee Atypical chest pain Constipation Cough Edema Insomnia Low back pain Obesity Pain in toe Snoring Urge and stress incontinence GAD (generalized anxiety disorder)",,n.a,"['C-reactive protein increased', 'Chest X-ray normal', 'Cough', 'Dehydration', 'Diarrhoea', 'N-terminal prohormone brain natriuretic peptide increased', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 942922,AZ,76.0,F,None stated.,Not Reported,,Not Reported,Yes,,Not Reported,U,,,,PHM,none,gallstones,none,,none,['Unevaluable event'],UNK,PFIZER\BIONTECH, 942992,OH,37.0,F,"developed sudden red hot itchy rash w raised bumps at injection site.. did not know was pregnant at the time of vaccine , positive pregnancy test a week after injection, current estimayed due date September 15th",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/11/2021,7.0,PVT,"prenatal vitamins, iron, vitamin d",,,,scallops,"['Exposure during pregnancy', 'Injection site erythema', 'Injection site papule', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,MODERNA,IM 943010,MA,36.0,F,Peripheral neuropathy,Not Reported,,Not Reported,Not Reported,,Yes,N,12/17/2020,12/30/2020,13.0,PVT,"MVI, Vit D, Vit C, quercentin, NAC",None,None,,NKDA,"['Blood test normal', 'Magnetic resonance imaging', 'Neurological examination abnormal', 'Neuropathy peripheral']",1,PFIZER\BIONTECH,SYR 943016,PR,53.0,F,"FIRST DOSE- FEELING HOT, CHILLS, TIREDNESS, MILD HEADACHE AND GENERAL BODY PAIN SECOND DOSE-FEVER, CHILLS, SEVERE HEADACHE, ITCHY IN THE VACCINATION AREA AND PAIN IN THE VACCINE ARM AND RADIATES UNDER THE ARMPIT TO THE BREAST AND DIARRHEA",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,WRK,"Inderal Atacand Crestor Vitaminas C, D3",Hypertension,,,Sulfa,"['Axillary pain', 'Breast pain', 'Chills', 'Diarrhoea', 'Fatigue', 'Feeling hot', 'Headache', 'Injection site pain', 'Injection site pruritus', 'Pain', 'Pyrexia']",2,UNKNOWN MANUFACTURER,IM 943041,PR,44.0,F,"THREE DAYS OF SYMPTOMS, DIZZINESS,WEAKNESS,PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,SWELLING ON INJECTION SITE,NAUSEA,INFLAMATION OF NODES.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PHM,TYLENOL,BACK PAIN,CHRONIC RESPIRATION,,NONE,"['Arthralgia', 'Asthenia', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Inflammation', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 943062,PR,45.0,F,"FIVE DAYS OF SYMPTOMS, PAIN INJECTION SITE, TIRED, MUSCULAR PAIN, CHILLS, JOINT PAIN, SWELLING INJECTION SITE, FEELING BAD.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,NONE,CHRONIC RESPIRATION,,NONE,"['Arthralgia', 'Feeling cold', 'Injection site pain', 'Injection site swelling', 'Malaise']",2,PFIZER\BIONTECH,IM 943068,IA,32.0,F,"Around 8 minutes post-vaccination patient started complaining of itching in her eyes and legs. RN in room with patient, vitals obtained immediately. While obtaining patients vitals, patient started to feel tingling on her face starting at her cheeks and going down towards her mouth, but no itching or swelling of mouth, throat, or tongue. NP brought into room to evaluate patient and Benadryl 50 mg given at 1125. Patient expressed that tingling was spreading to jaw and down into neck. 911 called at 1127 per recommendation from NP. While waiting for EMT's to arrive, patient complained of tingling down to her chest at 1133, and the tingling progressed down to her legs at 1136. Patient still denied any difficulty breathing, trouble swallowing, shortness of breath, swelling of mouth, lips, and/or tongue. Patient was able to talk without any difficulty during the entire event. EMT's arrived at 1139 and patient walked out to ambulance without assistance and was transported to ER for evaluation. At ED, pt reports she started getting tingling sensation all over her body, fullness sensation in her throat, feeling flushed, itching eyes and all over her body within 10 minutes of receiving vaccine. Pt notes she has had antibiotic allergies in the past that are very similar to this experience. Pt also endorses numbness/tingling sensation stretched from head to just below abdomen. Pt received famotidine 20 mg IV x 1, methylprednisolone 125 mg IV x 1, 1L NS IV x 1 (in addition to diphenhydramine 50 mg PO x 1 she received at clinic). Pt states she felt no improvement so diphenhydramine 50 mg IV x 1 ordered. Half hour later pt felt she wsa not getting worse, but not better and she stated her thoat felt full and she had tingling all over. Pt received albuterol 2.5 mg nebs x 1 and epinephrine 0.3 mg IM x 1. Discharged to home with prescrpitions for Medrol Dosepak 4 mg PO tabs x 6 days, famotidine 40 mg PO QHS x 5 days, hydroxyzine 25 mg PO QID PRN x 5 days. Instructed to return to ED with worsening condition and to discuss 2nd dose of vaccine with PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,WRK,Alprazolam 0.25 mg tab PO BID Prenatal multivitamin 1 tab PO QD Claritin 10 mg PO QD Sertraline 100 mg PO QD,,Abdominal Wall Mass Desmoid Fibromatosis Extra Toe Mass of Left Axilla,,"Ceftriaxone - facial rash, bilateral hand paresthesias, eye swelling Sulfamethoxazole-trimethoprim - swelling around eyes, itching","['Eye pruritus', 'Flushing', 'Hypoaesthesia', 'Paraesthesia', 'Pruritus', 'Throat tightness']",1,MODERNA,IM 943070,VT,22.0,F,"Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: chest/throat tightness-Medium",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,SEN,,,,,none listed,"['Anaphylactic reaction', 'Chest discomfort', 'Rash', 'Throat tightness']",1,PFIZER\BIONTECH,IM 943095,PR,33.0,M,Pt experienced 103.7 fever and muscle spasms. Hospitalized.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/12/2021,01/12/2021,0.0,MIL,None,None,None,,Tremedol,"['Muscle spasms', 'Pyrexia']",1,MODERNA,IM 943158,MA,39.0,F,"Numbness tingling in feet, toes progressed to waist. ER Sunday hosp, pt was admitted inpatient, diagnosis transverse myelitis.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,12/23/2020,01/06/2021,14.0,PVT,"Sertraline 75 mg, Baby aspirin, Metoprolol 60 mg as needed",,"Depression, Anxiety Brain Aneurysm and Brain Cyst",,Monk Fish,"['Angiogram cerebral', 'Arteriogram carotid', 'Blood test', 'Computerised tomogram head', 'Hypoaesthesia', 'Immunology test', 'Lumbar puncture', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging spinal', 'Myelitis transverse', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 943163,MI,40.0,F,"Systemic: Dizzy, hyperventolation-Medium",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/04/2021,01/04/2021,0.0,SEN,,,,,KNDA,"['Dizziness', 'Hyperventilation']",1,MODERNA,IM 943220,NJ,43.0,F,"Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips, was sent to the ED for observation. Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing, vomiting, shortness of breath. Noted to have uvular swelling and wheezing on examination. Given Benadryl, Pepcid, Solumedrol, Zofran, Albuterol MDI, Epi IM. within a few minutes symptoms returned and were worse where I felt like I could not breathe, throat was closing, could not talk. Noted to be pale, HR in 140?s. Given second dose of epi IM and symptoms improved. Was transferred to Obs Unit., within 2 hours (approx 6 hours after administration), developed SOB, throat tightness, cough, vomiting, difficulty breathing. Again noted to have swelling of uvula, wheezing on exam. Given Solumedrol, Benadryl, SQ epi, Albuterol, Racemic Epi nebulizer. Was transferred to ICU, all meds held except Pepcid. Day #2 ~10 am (25 hours from administration) developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and wheezing. Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb. Solumedrol started q12hour dosing. Strange feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms. Following morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing. Given Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer. Solumedrol changed to q8 dosing. Approx 4 hrs later nurse noted rash worse on face, associated with itching, throat tightness. Given additional Benadryl, Racemic Epi neb with improvement. Rash continued that night with throat tightness, got additional Benadryl and Racemic Neb that night (total of 3 Racemic nebulizer on Day#2 post vaccine). Transferred to telemetry floor. Day#3 post vaccine rash improved, but still present to chest and face. Throat fullness present, especially after drinking. Am still hospitalized while writing this report",Not Reported,,Yes,Yes,4.0,Not Reported,U,01/11/2021,01/11/2021,0.0,PVT,Multivitamin,No,None,,No,"['Cough', 'Dysphagia', 'Dyspnoea', 'Enlarged uvula', 'Feeling abnormal', 'Intensive care', 'Oral pruritus', 'Pallor', 'Paraesthesia oral', 'Rash', 'Rash erythematous', 'Rash pruritic', 'Speech disorder', 'Throat tightness', 'Tongue pruritus', 'Vomiting', 'Wheezing']",2,PFIZER\BIONTECH,IM 943266,AZ,88.0,F,"Initial pain in back of head and extreme headache. Some vomiting. At emergency, went into coma and was intubated. Hole drilled in skull to relieve pressure. MRI taken. Lot of bleeding in brain - anuerism lead to death approximately 14 hours after initial symptoms.",Yes,01/13/2021,Not Reported,Yes,1.0,Not Reported,N,01/12/2021,01/12/2021,0.0,OTH,"Losartan, Levothyroxine, Carvedilol",,"Arthritis, high blood pressure",,"Penicillin, Sulfa, Gluten","['Cerebral haemorrhage', 'Coma', 'Craniotomy', 'Death', 'Endotracheal intubation', 'Headache', 'Intracranial aneurysm', 'Magnetic resonance imaging brain abnormal', 'Vomiting']",1,PFIZER\BIONTECH,SYR 943272,MO,42.0,F,Systemic: Anaphylaxis-Medium; symptoms lasted 1 day,Not Reported,,Yes,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,SEN,,,,,"Latex, other products not listed on vaccine administration form",['Anaphylactic reaction'],1,MODERNA,IM 943359,KS,38.0,F,"Unprovoked seizure (clonic tonic) 13 days later, requiring hospitalization and testing",Not Reported,,Yes,Yes,2.0,Not Reported,U,12/30/2020,01/12/2021,13.0,PVT,"Zoloft, buspirone, multivitamin, protonix",None,Obesity,,"Betadine, citalprozam","['Computerised tomogram', 'Electroencephalogram', 'Generalised tonic-clonic seizure', 'Laboratory test', 'Magnetic resonance imaging brain']",1,PFIZER\BIONTECH,IM 943362,MI,73.0,F,Pt collapsed at home approx 5:30 pm and died,Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/13/2021,0.0,PUB,unknown none reported,none known,none,,none reported,"['Autopsy', 'Death', 'Syncope']",1,MODERNA,IM 943397,NJ,28.0,M,"On day due for 2nd dose, Patient was found unresponsive at work in the hospital. Patient pupils were fixed and dilated. Full ACLS was initiated for 55 minutes with multiple rounds of bicarb, calcium chloride, magnesium, and epinephrine. Patient was intubated. Patient continued into V. Fib arrest and was shocked multiple times.",Yes,01/11/2021,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/11/2021,19.0,PVT,None,None,None,,"Ceclor, Penicillin, Sulfa","['Cardiac arrest', 'Cardioversion', 'Endotracheal intubation', 'Pupil fixed', 'Unresponsive to stimuli']",UNK,PFIZER\BIONTECH,IM 943423,NC,30.0,F,"Adverse event contacted by V-safe was that I was unable to perform my job duties the day after the vaccine. Symptoms included left arm pain, back pain, aches/chills starting at midnight on 1/6/21 into 1/7/21. Headache lasted all day, slept intermittently all day, low energy and extreme fatigue. Was 13 weeks pregnant at the time of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,Prenatal Vitamin,None,None,,None,"['Asthenia', 'Back pain', 'Chills', 'Exposure during pregnancy', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 943442,GA,68.0,M,"Systemic: reported by staff patient expired under suspicious circumstnces after receiving vaccine. Patient was on hospice, reported not expected to pass this soon; symptoms lasted 0 days",Yes,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,SEN,,,,,nka,['Death'],1,PFIZER\BIONTECH,IM 943506,MD,39.0,F,Shingles under R breast Valtrex 1g tid x 7 days,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/12/2021,01/12/2021,0.0,WRK,"Vit D, Vit C, magnesium",,none,,Pcn,['Herpes zoster'],1,PFIZER\BIONTECH,IM 943507,PA,78.0,F,"Resident, , initially started on the 11th with mental status changes. She was unable to follow directions, pocketing food, all new for her. She was sent toHospital ( and she was sent back with orders to monitor and increase fluid intakes. On 1/13/2021 was found seizing and was again transferred to hospital where she was admitted with a seizure diagnosis which is a new diagnosis for her.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/08/2021,01/11/2021,3.0,SEN,"Aricept daily, Aspirin daily, Vitamin D3 daily, Melatonin q hs, Multi-vitamins with minerals daily, Miralax daily, Seroquel TID, Rosuvastatin daily, Gabapentin daily, Senna BID, Acetaminophen q 8 hours, Diclofenac gel TID,",None,Schizoeffective disorder GERD Hyperlipidemia,,"Amoxicillin, Pseudoephedrine, Latex, Tape","['Feeding disorder', 'Mental status changes', 'Seizure', 'Unresponsive to stimuli']",1,UNKNOWN MANUFACTURER,IM 943510,PR,33.0,F,"Patient reports that after vaccine administration she presented redness in the injection site, arm pain, and induration. Patient refers that she applied ice on the area and took Panadol.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/07/2021,0.0,WRK,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pain']",UNK,MODERNA,IM 943550,CA,,F,"loss of consciousness; felt flush; felt hot / felt warm; This case was reported by a pharmacist via call center representative and described the occurrence of loss of consciousness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. In November 2020, the patient received the 1st dose of Shingrix. In November 2020, 1 day after receiving Shingrix, the patient experienced loss of consciousness (serious criteria GSK medically significant), flushing and feeling hot. On an unknown date, the outcome of the loss of consciousness, flushing and feeling hot were unknown. It was unknown if the reporter considered the loss of consciousness, flushing and feeling hot to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced loss of consciousness, felt warm, felt hot, and felt flush the next day, one day after the first dose of Shingrix (unknown day in November 2020). Consented to follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,11/01/2020,11/01/2020,0.0,UNK,,,,,,"['Feeling hot', 'Flushing', 'Loss of consciousness']",1,GLAXOSMITHKLINE BIOLOGICALS, 943585,MO,31.0,F,Extreme lockjaw unable to barely talk or chew,Not Reported,,Not Reported,Not Reported,,Yes,N,01/08/2021,01/11/2021,3.0,PVT,"Ritalin, ambilify, propranolol, hydrochlothiazide,.",None,None,,"Haldol, keppra","['Mastication disorder', 'Speech disorder', 'Trismus']",1,PFIZER\BIONTECH, 943614,AR,51.0,F,"Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30am, told my husband that I did not feel right and it felt like something was wrong with me. I asked him to send a message to work that I was not feeling well and would not be in. I was not able to see my phone clearly as I had double vision. I went back to sleep to try to get relief, woke up and called out to husband for help and he said I was just making groaning noises but I know in my head I was saying please help me as I could not move my right side and I was not sleeping or having a dream. At approximately 9:30am my husband kept telling me someone was trying to text me and needed a response. I tried to get up and still could not move my right side. He helped me sit up and I could not use my right arm and hand. He helped me get some clothes on and took me to the ED. When we arrived I still could not use my right hand and my arm still felt weak. The weakness resolved within a couple of hours and I got the strength back in my hand. I did have some concern that my TIA type symptoms could possibly be related to vaccine but it was just a thought until I received my second dose. 3 hours post vaccine my face became numb and tingly. It remained that way until I went to sleep. This is why I am reporting this incident.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/21/2020,12/28/2020,7.0,PVT,"Dupixent 300mg injection every two weeks, diazapem 5mg PRN, albuterol inhaler PRN, Claritin, ocuvite vitamin, calcium/mag/vit d, multivitamin with iron, methyl folate +,",None,"Obesity, PCOS",,"Biaxin, Skelaxin, Codeine, Morphine","['Angiogram cerebral', 'Arteriogram carotid', 'Blood glucose', 'Diplopia', 'Echocardiogram', 'Electrocardiogram', 'Feeling abnormal', 'Full blood count', 'Glycosylated haemoglobin', 'Hypoaesthesia', 'Impaired work ability', 'Lipids', 'Loss of personal independence in daily activities', 'Magnetic resonance imaging brain', 'Metabolic function test', 'Moaning', 'Muscular weakness', 'Musculoskeletal disorder', 'Nausea', 'Paraesthesia', 'Speech disorder', 'Urine analysis', 'Vertigo']",2,PFIZER\BIONTECH,IM 943667,TX,43.0,F,"Per patient report on follow-up: admitted to hospital following initial vaccine on 12/29 with N/V and severe HA. Patient placed on Morphine for pain, now resolved. Admission occurred outside of hospital system providing initial vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,"furosemide, tacrolimus, myfortic",,,,Cefazolin. penicillins,"['Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 943741,OR,71.0,M,Patient reports no symptoms until 1/8/21 at which time a rash developed along with fatigue and fevers. Patient was seen in ED 1/8 and 1/11/21. Was admitted 1/11/21 with Concern for STevens Johnson and sepsis. Patient subsequently developed full body macular rash and mucosal lesions. Fevers to 102-104.,Not Reported,,Yes,Yes,3.0,Not Reported,N,12/23/2020,01/08/2021,16.0,PVT,,"Prostate Cancer, completing radiation therapy","Prostate Cancer undergoing radiation therapy, history of Afib",,Azithromycin,"['Fatigue', 'Mucosal inflammation', 'Pyrexia', 'Rash', 'Rash macular']",1,PFIZER\BIONTECH,IM 943759,IA,58.0,F,"Reported redness, swelling and pain at injection site, diarrhea and light headedness1/5/21. Evaluated in ED and hospitalized for neurological symptoms that started 1/8/21.",Not Reported,,Not Reported,Yes,,Not Reported,U,12/29/2020,01/05/2021,7.0,PVT,,,,,,"['Diarrhoea', 'Dizziness', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Neurological symptom']",1,MODERNA,IM 943801,GA,37.0,F,"PATIENT HAD ACUTE ONSET PROSTRATION STRIDER, CHEMOSIS AND ALTERED MENTAL STATUS. ADMINISTERED EPIPEN, AND THEN ORAL BENADRYL, PREDNISONE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,MIL,"TIZANIDINE, DULOXETINE",NONE,Low Back pain,,NKDA,"['Conjunctival oedema', 'Fatigue', 'Mental status changes']",1,MODERNA,IM 943802,TX,55.0,F,"Burning sensation in throat, coughing, Sunday 1/10 redness, swelling and itching at site Txt: Antihistamine tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/10/2021,5.0,WRK,Tylenol & vitamin B12,Denies,Breast Ca Biopsy,,NKDA,"['Cough', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Throat irritation']",1,MODERNA,IM 943813,MO,41.0,F,"Approximately 5 minutes after receiving the vaccine, pt reported feeling light-headed and a sensation that her heart was racing . Slightly elevated BP returned to baseline by 1436.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,,,,,,"['Blood pressure increased', 'Dizziness', 'Palpitations']",1,PFIZER\BIONTECH,IM 943814,NY,25.0,F,"vaccinated at Hospital on 1/12/2021. According to patients father she developed stomach pains, constant vomiting, sweating which started at approx. 4am. She arrived at Medical center at approx. 7:20 stating she had been vomiting since 4am. Attempted PO fluids while in ED. Uncontrolled nausea persisted despite medication. Admitted to Hospital for observation for uncontrolled nausea. IV fluids given",Not Reported,,Not Reported,Yes,,Not Reported,U,01/12/2021,01/13/2021,1.0,PVT,unknown,,,,,"['Abdominal pain upper', 'Hyperhidrosis', 'Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 943823,MO,22.0,F,"Approximately 10 minutes after receiving injection, patient reports feeling tightness in her throat. Benadryl 25mg po given & taken to ED via WC.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,none,none,none,,none,['Throat tightness'],2,PFIZER\BIONTECH,IM 943836,MO,,F,"Approximately 30 minutes after receiving injection, patient began to c/o itching to (B)UE, chest, and neck. Visible hives to (L) forearm. Denies further symptoms. Benadryl 25mg po. Patient declined further treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,,none,,,,"['Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,IM 943837,MA,32.0,F,"Approximately 5 days after administration at 6 weeks pregnant, I began bleeding. The following day (6 days after administration) miscarriage was confirmed via ultrasound",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/12/2021,5.0,PHM,"Levetiracetam 500mg , Folic acid 4mg, prenatal vitamin, vitamin C 500mg, Zinc 50mg, Omega 3 fatty acids",,Seizure disorder,,Amoxicillin,"['Abortion spontaneous', 'Exposure during pregnancy', 'Haemorrhage', 'Human chorionic gonadotropin negative', 'Ultrasound scan vagina abnormal']",1,PFIZER\BIONTECH,IM 943859,FL,54.0,F,next page,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/12/2021,0.0,PVT,next page,none,next page,,next page,['Unevaluable event'],1,MODERNA,IM 943867,IL,49.0,F,"-Right hand & forearm numbness/within 10 minutes of vaccine -Fever, Bodyacheeks, headackes, -Pain on the right side - Jaw, neck & right -Lyphnote under the right arm is swollen. -Neck & under armpit pain because of this -The night after getting the 2nd vaccine Covid I started getting chills, fever of 102+ Extreme body ackes -Right arm armpit lymph nodes swollen the size of my fist -Right side of my neck also swollen -The Right lower back hurts as well -From 1 to 10 is an 8 acute pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/10/2021,0.0,PVT,"Humira, Vitiamins, Fluticasone, Bupropion XL 300mg Trazodone",None,"Arthritis,",,Aspiri.,"['Axillary pain', 'Back pain', 'Chills', 'Headache', 'Hypoaesthesia', 'Lymphadenopathy', 'Neck pain', 'Pain', 'Pain in jaw', 'Pyrexia', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH, 943868,GA,66.0,M,"Developed pulmonary embolism in right lung one week after vaccination. Sharp pain on right side when breathing. Treated with IV Apixaban while inpatient for 2 days, oral Apixaban 5 mg, 2 tabs twice daily 1/5/21-1/11/21, then one 5 mg tab twice a day. Pain has subsided as of 1/14/21.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,12/28/2020,01/04/2021,7.0,OTH,zyrTEC 10 mg 1 tab daily; BuPROPion Hal XL 300 mg 1 tab daily; Furosemide 40 mg 1 tab daily; Mirapex 1 mg 3 tabs at bedtime; Lipitor 40 mg 1 tab at bed time; Seroquel 100 mg tab 2 tabs at bedtime; Pyridoxine Hal 50 mg 2 tabs twice daily; G,None,"Type 2 Diabetes, HBP",,,"['Computerised tomogram', 'Painful respiration', 'Pulmonary embolism', 'X-ray']",UNK,PFIZER\BIONTECH,IM 943869,AZ,36.0,F,"redness at injection site, swollen eyelid, congestion, chest tightness all started 8 days after vaccine. prior to this, there was no redness at the injection site or facial welling or other nasal/chest symptoms. reported on v-safe program daily for one week, then v-safe stopped allowing reporting. other than this, only other symptoms were arm soreness for 12 hours and a bump at injection site for 48 hours. Again, redness and facial swelling started 8 days post vaccination. 5 weeks pregnant at time of vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/13/2021,8.0,PVT,"levothyroxine, singulair, zyrtec, prenatal vitamin",,hypothyroidism,,"avocado, mango","['Chest discomfort', 'Exposure during pregnancy', 'Injection site erythema', 'Injection site nodule', 'Respiratory tract congestion', 'Swelling of eyelid']",1,MODERNA,IM 943889,VA,75.0,M,No adverse reactions observed after administration of medication. Patient starting complaining of shortness of breath around 0500 the following morning. SP02 checked in the 80s. Patient expired 01/09/2021;,Yes,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,OTH,"Alvesco, Amiodarone, Lipitor, Atrovent, Coreg, Cymbalta, Guaifenesin, Keppra, Levothroid, Megace, Protonix, Potassium, Prednisone, Rifampin, Carafate, Bactrim, Flomax","Rigth femur fracture, GI bleed","Hypertension, seizure, hypothyroidism, CHF",,No known allergies,"['Death', 'Dyspnoea']",1,MODERNA,IM 943967,RI,38.0,F,"Soreness at the injection site, arm pain, headache and full body chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/11/2021,1.0,PVT,Buspirone 10 twice daily Prenatal Vitamins,None,Anxiety Acid Reflux,,None,"['Chills', 'Headache', 'Injection site pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 943978,RI,38.0,F,"Soreness at the injection site, arm pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/21/2020,1.0,PVT,Prenatal Vitamins,None,Anxiety Acid Reflux,,None,"['Injection site pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 944092,PR,40.0,F,"In the early morning around 3:00 a.m. presented swelling in the eyes, numbness of the tongue, swollen mouth and tingling in the face. where it took a Benadryl at the time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,OTH,Benadryl Zyrtec,No disease,None,,"Medications: Penicillin, Aspirin","['Eye swelling', 'Hypoaesthesia oral', 'Mouth swelling', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 944134,HI,56.0,F,"56 yo female from pharmacy presented to the observation room at ~1116 after receiving COVID vaccine. She reports feeling weakness and dizziness. She states she fellt sensation to her neck immediately after she got the vaccine. Pt appears very anxious. Provided cold pack behind her neck and vital signs taken 152/90 with HR 98 O2 SAT 98%. Pt then taken to the gurney to lay down. Pt continued to feel weak with short of breath, tingling finger tips. 100% NR mask provided, Dr notified and arrived immediately. vital signs taken every 5-10 min with b/p trending down within 20 minutes. Pt states felt better around 1150. Attempted to sit up but states felt weak again. Pt felt anxious and wanted to speak to her husband, Medic, called husband and was able to speak to him. Pt continues to feel weak. Continue to monitor and comfort provided. Discussed with medical team that patient need to be sent to the ER for further observation. 911 called at 1215 and arrived within few minutes, report given to EMS. Patient transferred to ER at 1230 via gurney. 1117: 152/90,HR 103, O2 sat 98% 1121: 144/72, HR 89, O2 SAT 99%-applied O2 100% non rebreather mask 1126: 153/88, HR 80 1142: 160/92, HR 85, O2 SAT 100% 1147: 147/85, HR 77, O2 SAT 100% 1152: 136/85, HR 70, 02 SAT 100% 1202: 133/81, HR 68, 02 SAT 99%",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/29/2020,12/29/2020,0.0,MIL,,,,,,"['Anxiety', 'Asthenia', 'Dizziness', 'Dyspnoea', 'Immediate post-injection reaction', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 944169,DE,59.0,M,"altered mental status, hypoxic, fever 39.3, agitated",Not Reported,,Yes,Yes,15.0,Not Reported,Y,12/29/2020,12/29/2020,0.0,SEN,metoprolol amlodipine hydralazine omeprazole,"hx CKD, DM, HTN lymphedema, bipolar d/o, previous covid infection dx 11/21 now admitted 12/29 with altered mental status, hyopxemic resp failure",see above,,lisinopril seasonal allergies,"['Agitation', 'Band neutrophil percentage increased', 'Blood creatinine increased', 'Blood culture', 'Blood glucose normal', 'Blood pH increased', 'Haemoglobin decreased', 'Hypoxia', 'Mental status changes', 'Neutrophil percentage increased', 'Nitrite urine', 'Pyrexia', 'Respiratory failure', 'Urine leukocyte esterase positive', 'White blood cell count decreased', 'White blood cells urine positive']",1,PFIZER\BIONTECH,IM 944201,CA,,U,"a positive Covid test after receiving their first dose; a positive Covid test after receiving their first dose; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 06Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable other healthcare professional (student pharmacist) and a contactable pharmacist reported that a patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration, on an unspecified date, at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter that works at a hospital pharmacy called about a patient that received their first dosage of COVID-19 vaccine who had a positive COVID test on an unspecified date after receiving their first dose of the vaccine. They wanted to know hoe to proceed and if they needed the second dose. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 944203,NY,31.0,F,"covid a week after the1st dose of the vaccine. When to get the 2nd dose?/tested positive for COVID; covid a week after the1st dose of the vaccine. When to get the 2nd dose?/tested positive for COVID; body aches; fever; Headache; This is a spontaneous report from a contactable physician. A 31-year-old female patient (healthcare worker) received the 1st dose of bnt162b2 (BNT162B2) at single dose in Dec2020 (9 days before 07Jan2021) for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the 1st dose of the COVID vaccine 9 days before 07Jan2021 and got a headache afterward in Dec2020. After 6 days, in Jan2021 the patient had a worse headache, body aches, and fever. She was swabbed for COVID on 06Jan2021 and tested positive. The reporter wanted to know what to do about the 2nd dose. The outcome of events was unknown. A product complaint was filed. information about lot and batch number was requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 944204,CA,47.0,F,"tested positive for covid/headache, ever, cough, diarrhea; tested positive for covid/headache, ever, cough, diarrhea; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program IBCC (Inbound Call Center for HCPs). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, expiration date: 20Mar2021), via an unspecified route of administration on 19Dec2020 16:15 at left arm, at single dose for covid-19 immunization. Medical history included hysterectomy in 2010, pulmonary Embolism in 2010, gallbladder removed on an unknown date. There were no concomitant medications. The patient received 1st dose 19Dec2020, she was supposed to get her second dose, but tested positive for covid. She thought she had side effects after vaccine, she began with a headache, fever a week later and thought they were from the vaccine, but then her sister-in-law was positive for COVID, her sister-in-law passed away from covid virus. Then the patient, her mom, and husband tested positive for COVID. She tested positive for COVID on 27Dec2020. She developed symptoms of COVID on 27Dec2020. It was exactly one week after receiving the first dose. It was also reported that she got tested on the 30th (as reported) and received results on 31Dec2020 that she was positive. After she got sick she has taken Mucinex. Day eleven, she is doing ok, but has a little cough. No more fever. Sometimes she has diarrhea but today no diarrhea. The patient asked if she can get her second dose of the covid vaccine on day 24. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/27/2020,8.0,PVT,,,Medical History/Concurrent Conditions: Gallbladder disorder (Gallbladder removed- unknown date); Hysterectomy; Pulmonary embolism,,,"['Cough', 'Diarrhoea', 'Headache', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 944208,FL,43.0,F,"arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy. The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL). The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant. On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly. On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened. The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown. The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Chest discomfort', 'Dysgeusia', 'Erythema', 'Feeling abnormal', 'Pain in extremity', 'Pruritus', 'Skin warm', 'Swelling']",1,PFIZER\BIONTECH,OT 944210,MA,34.0,F,"The patient had an ongoing medical history of Crohn's disease/Concomitant medication included vedolizumab (ENTYVIO) for Crohn's disease; shortness of breath; difficulty swallowing; fever; headache; nausea; she was feeling as if her throat was closing; Chest tightness; This is a spontaneous report from a contactable physician reporting for a patient. A 34-year-old female patient received the first dose of BNT162B2 (COIVD-19 Vaccine) , via an unspecified route of administration on 03Jan2021 at single dose for covid-19 immunisation. Medical history included Crohn's disease from an unknown date and unknown if ongoing, COVID-19 in 2020 to an unknown date and unknown if ongoing. Concomitant medication included vedolizumab (ENTYVIO) for Crohn's disease. The reporter is a physician who is reporting and AE for a patient who received the vaccine and subsequently developed symptoms including short of breath, fever, headache, nausea, difficulty swallowing with seriousness criteria of Medically significant on 03Jan2021. The patient self-medicated with benadryl and symptoms resolved briefly but then went to urgent care with re-occurring symptoms and was prescribed prednisone. Caller states the patient's symptoms have resolved. She is calling to get more information to determine if the patient should receive the second dose. The reporter further stated that she has a patient who received her first shot, clarified as the COVID-19 Vaccine. About an hour and 45 minutes later, the patient had shortness of breath and then later had a fever, headache and nausea. It was later that night when the patient had a fever. The patient had difficulty swallowing which worsen; she was feeling as if her throat was closing. The patient is a nurse, so she self medicated with Benadryl. After taking the Benadryl, the patient was better in the early morning. When the doctor's office opened, the patient called and was having similar symptoms, clarified as all the symptoms mentioned above. The patient went to the urgent care where she received more Benadryl and was started on prednisone. Caller did not know the dose of prednisone the patient had received. After that, the patient started feeling better. The patient's second dose of the COVID19 Vaccine is due around 24 to 26Jan2021. The patient has not called the doctor/caller back. The caller assumes that the patient has recovered but could not be certain. Caller added that the patient also experienced chest tightness when she was having shortness of breath. The patient's fever was 101 on 03Jan2021. The patient was not drooling with her difficulty swallowing. Caller stated that the patient had a positive COVID test earlier, she thinks it was maybe 3 to 4 months ago (in 2020). The patient has not received another COVID test since she received the first dose of the COVID-19 vaccine to the caller's knowledge. Reporting physician is an internal medicine physician. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported short of breath, fever, headache, nausea, difficulty swallowing, throat closing, chest tightness, and the administration of COVID 19 vaccine, BNT162B2, based on the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,UNK,ENTYVIO,,Medical History/Concurrent Conditions: COVID-19; Crohn's disease,,,"['Chest discomfort', 'Dysphagia', 'Dyspnoea', 'Headache', 'Nausea', 'Pyrexia', 'Throat tightness']",1,PFIZER\BIONTECH, 944216,CA,42.0,F,"headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this one turned red; can't lift her arm it's heavy and painful; can't lift her arm it's heavy and painful; shortness of breath; palpitation; Dizziness, lightheaded/ feeling dizzy; Uneasiness; hands are so cold; nauseous; This is spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on Left arm on 29Dec2020 17:00 PM on left arm at single dose (Lot # EL1284) for COVID-19 immunisation. Medical history included None. No Allergies to medications, food, or other products. Concomitant medications included ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C), collagen, colecalciferol (VITAMIN D), cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER). No other vaccine in four weeks. The patient experienced Dizziness, lightheaded, palpitation, uneasyness, shortness of breath on 29Dec2020 17:15 pm. Then when the patient drove home, she felt so uneasy and hands are so cold, nauseous and feeling dizzy on 29Dec2020 17:15 pm. Felt the same way in the house for a good 2 hours after the vaccination. Drank water and didn't sleep right away. Tried to monitor herself. After that day the patient felt better but with bouts of headache and dizziness every now and then. The injection site was itchy and swelled up. But it went down if didn't scratch it. The patient didn't have allergies to any medications. But this one turned red. And the next day after the vaccination (30Dec2020) the patient can't lift her arm it's heavy and painful. Then pain went away. But now it was the itchiness in the site that bothered her. But the patient didn't scratch it. So it didn't swell up as much. Prior to vaccination, was the patient did not diagnose with COVID-19. Lab data on 07Jan2021 Nasal Swab post vaccination for Covid 19: result was pending. No treatments received for the events. Outcome of the events Dizziness, lightheaded/ feeling dizzy, palpitation, Uneasiness, shortness of breath, hands are so cold, nauseous was recovering. Outcome of the event pain in arm was recovered. Outcome of other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dizziness, lightheaded, palpitation, shortness of breath and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PUB,VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]; ; VITAMIN D [COLECALCIFEROL]; APPLE CIDER,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Anxiety', 'Dizziness', 'Dyspnoea', 'Headache', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Limb discomfort', 'Mobility decreased', 'Nausea', 'Pain in extremity', 'Palpitations', 'Peripheral coldness', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 944218,,,F,"trouble breathing; She had bad pain in her chest; Her oxygen saturation dropped to 92 and it is usually 98 or 100; not been feeling well; A fast heartbeat 5-10 minutes after initial dose; This is a spontaneous report from a contactable healthcare professional (dental assistant) reporting for self. This female patient with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously had reactions with the flu shot in the past for immunisation and she only was able to take the vegan version of the flu shot due to the egg content in the regular version of the flu shot. She also stated not being able to take the flu shot in the arm, leg, hip etc. Patient stated she was scheduled to take her second dose of vaccine tomorrow. She received the first dose on 22Dec2020. She stated she was in the ER on Monday for 5 hours because she was unable to see her primary care physician because his office was filled with patients with Covid and they could not provide her with guidance. She stated after receiving the first dose of vaccine she had not been feeling well ever since. Stated she had had trouble breathing and this took her by surprise. She had bad pain in her chest and a fast heartbeat 5-10 minutes after initial dose (on 22Dec2020). Her oxygen saturation dropped to 92 and it was usually 98 or 100. She stated something inhibited her ability to breathe and this scared her because she was healthy prior to the vaccine and never been in hospital and wasn't born in the hospital. She stated the condition she was diagnosed with will take 6-12 months for her to recover from and go back to normal. She stated during her ER room visit there were a lot of tests done. She would like to know if she should receive the second dose of the vaccine. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dyspnea, chest pain, oxygen saturation decreased and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, arterial blood gas and pulmonary function tests, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,UNK,,,,,,"['Chest pain', 'Dyspnoea', 'Heart rate increased', 'Laboratory test', 'Malaise', 'Oxygen saturation decreased', 'Reaction to previous exposure to any vaccine']",1,PFIZER\BIONTECH, 944219,MN,90.0,M,"On 1/12/20 resident woke up and was not able to stand in the E-Z stand. E-Z lift was needed. In addition he needed assistance with eating. At that time VS were stable, equal hand grasp noted, and no further concerns. Around 3pm resident became flaccid on the left side of his face and speech became mumbled. Hand grasp was equal at that time and VS were stable, but B/P was elevated compared to previous recordings earlier in the day. Family did not want him sent to the hospital and asked for comfort cares. Hospice referral obtained and he will be admitted to hospice in the near future. Resident's left side of face has improved within the last 48 hours. He remains total assist with all cares.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/07/2021,01/12/2021,5.0,SEN,"Systane drops, Lipitor, Mirtazapine, Digoxin, Lasix, Aspirin, Cymbalta, Trazodone, Levothyroxine, Depakote, Biofreeze, Senna, Neurontin, Risperidone, Flovent HFA,","Resident has slowly been declining over the past several months. Physically he went from being able to walk, to needing the E-Z stand to transfer and most recently has become total assist with all ADL cares.","Cerebral Infarction, Occlusion and stenosis of left carotid artery, COPD, Hyperlipidemia, Hallucinations, Hypertension, Dizziness, Anxiety, Dementia",,No known allergies,"['Blood pressure increased', 'Condition aggravated', 'Dysstasia', 'Hypotonia', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Speech disorder']",UNK,MODERNA,IM 944229,,,U,"develops symptomatic covid; develops symptomatic covid; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. This physician reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed symptomatic Covid on an unspecified date. The patient received dose #1 of a Covid-19 vaccine and contracted Covid-19 prior to dose #2. The patient underwent lab test which included Covid-19 test in which he/she developed a symptomatic Covid-19 on an unknown date. Outcome of the event was unknown. Information about batch/lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021014755 Same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 944231,GA,23.0,F,"flushed; hives; tongue felt ""thick""; the lump in my throat feels bigger; This is a spontaneous report received from a contactable pharmacist. A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL0142), via an unspecified route of administration in the left arm on 22Dec2020 (at the age of 23-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: allergies to medications, food, or other products (unspecified). It was unknown if the patient was pregnant at the time of vaccination. The patient's concomitant medications were not reported. It was unknown if the patient received any other vaccine within 4 weeks prior to the vaccine. On 22Dec2020, approximately 8 minutes after vaccine administration, the patient began feeling flushed. She reported to the observation area, and the registered nurse noted hives on her left neck (22Dec2020). The patient was brought back for closer monitoring. The doctor evaluated the patient. Vital signs were monitored every 5 minutes (22Dec2020). The patient was given 50 mg diphenhydramine (BENADRYL) orally. Some improvement was noted in hives; however, the patient began to state her tongue felt ""thick"" and ""the lump in my throat feels bigger"" (both on 22Dec2020). Per doctor, 0.3 mg epinephrine (MANUFACTURER UNKNOWN) given intramuscularly with rapid improvement in hives. The patient reported feeling some improvement as well. The patient was taken to the emergency department for ongoing observation. The patient was released from emergency department after observation. The clinical outcome of flushed, hives, tongue felt ""thick"", and ""the lump in my throat feels bigger"" was recovered on an unspecified date.; Sender's Comments: Based on the compatible time association, the events flushing, urticaria, tong disorder, sensation of foreign body are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Drug allergy; Food allergy,,,"['Flushing', 'Sensation of foreign body', 'Tongue disorder', 'Urticaria']",1,PFIZER\BIONTECH, 944239,MO,55.0,F,"Egg sized lymphadenopathy under right arm 36 hours after 2D injection; flu symptoms; joint aches; muscle and joint aches; arm pain; arm pain and swelling; 1st dose of BNT162B2 on 17Dec2020 15:45/ 2nd dose on 06Jan2021 14:30; 1st dose of BNT162B2 on 17Dec2020 15:45/ 2nd dose on 06Jan2021 14:30; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 06Jan2021 14:30 at single dose for COVID-19 immunisation. Medical history included mild hypertension and arthritis. The patient was not pregnant. No Covid prior vaccination, no Covid tested post vaccination. No known allergies. Concomitant medication included estradiol, norethisterone acetate (COMBIPATCH), meloxicam, propanol. The patient previously received 1st dose of BNT162B2 in left arm on 17Dec2020 15:45 for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced egg sized lymphadenopathy under right arm 36 hours after 2D injection (08Jan2021 03:00), after flu symptoms of muscle and joint aches, arm pain and swelling at 20 hours (07Jan2021 12:00). No treatment received for the events. The outcome of events was not recovered. This case was reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of lymphadenopathy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,COMBIPATCH; ;,,Medical History/Concurrent Conditions: Arthritis; Hypertension,,,"['Arthralgia', 'Influenza', 'Lymphadenopathy', 'Myalgia', 'Pain in extremity', 'Peripheral swelling']",2,PFIZER\BIONTECH, 944244,OH,54.0,F,"She was wiped out the next day with aches and pains still.; tired; brain fog; started to get cold; shake/her hands were shaking so hard; they took her temperature and it was 100/her fever went to 101/temperature had gone to 102.6; heart rate was elevated at 100/heart rate was 110/heart rate went to the high 120s; headache; backache; nauseated; chest was hurting; The initial case was missing the following minimum criteria: Invalid for unspecified adverse event. Upon receipt of follow-up information on 08Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration in deltoid left on 29Dec2020 07:30 at single dose for COVID-19 immunisation. Medical history included ongoing sleep apnoea (diagnosed about 3-4 years ago, wear her CPAP religiously), Hashimoto's hypothyroid, and chronic low vitamin d (lack of sunlight). Concomitant medication included levothyroxine sodium (SYNTHROID) from 2016 and ongoing for Hashimoto's hypothyroid, ergocalciferol (VIT D) from 2018 for chronic low vitamin d; lack of sunlight (She did not take it religiously, but was supposed to take it everyday). At 10:30 AM (29Dec2020), she started to get cold and shake. She thought that this was insane and it was in her head. It became so severe she could not use her computer her hands were shaking so hard. She went back up to where they were giving vaccines, they took her temperature and it was 100. It had been normal the morning before she got the vaccine. Her heart rate was elevated at 100. They put a blanket on her and said they wanted to watch her for 15 minutes. In that time her fever went to 101 and her heart rate was 110. They took her to the ER. She was there for 5 hours. Her heart rate went to the high 120s. They did a 12 lead EKG. Her temperature had gone to 102.6, which was the highest. They gave her a liter of Normal Saline. She also had a headache, backache, and felt nauseated. The liter of fluid helped, no doubt. She was not admitted. She was wiped out the next day (30Dec2020) with aches and pains still. Their concern was they said they did not give her epinephrine because her heart was too high. She had no breathing issues. Just extreme cold. At one point she had woke up in the ER (29 or 30Dec2020) and her chest was hurting, she knows from her heart rate being too fast. She was so cold. She had on 6 blankets. The next day (30Dec2020) she still had the aches and pains, she was tired, and had brain fog. It all went away on 30Dec2020. She had nothing after that. What scared her was the heart rhythm. The ER doctor says its not great, but felt that getting the second dose was better than her having COVID. The Electrophysiologist she saw, said she was unsure if she should get the second dose. The hospital said that for this next dose, they would give her the injection, wait 15 minutes, then send her home, expecting that she would have the same thing happen. When after the first dose, she was in the ER on a 12 lead EKG with an intravenous (IV). She had no arm pain the whole time. The reporter assessed all events related. She felt fine prior, walking in to get the vaccine. But she was much better the next day and recovered completely. She was just worried about the second dose. The outcome of events was recovered on 30Dec2020.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/01/2020,,UNK,SYNTHROID; VIT D,Sleep apnea,Medical History/Concurrent Conditions: Hypothyroidism; Vitamin D low (Chronic low vitamin d; lack of sunlight),,,"['Back pain', 'Chest pain', 'Electrocardiogram', 'Fatigue', 'Feeling abnormal', 'Feeling cold', 'Headache', 'Heart rate increased', 'Nausea', 'Pain', 'Pyrexia', 'Tremor']",1,PFIZER\BIONTECH, 944252,FL,64.0,M,"Myocardial Infarction; This is a spontaneous report from a contactable Other healthcare professional (patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: 20201216-1), via an unspecified route of administration on 16Dec2020 08:15 at single dose for COVID-19 immunization, vaccine location provided as Left arm. Medical history included arthritis and sulfa allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced myocardial infarction on 19Dec2020 23:00. The patient was hospitalized for myocardial infarction for 3 days. The patient underwent lab test which included Covid test via Nasal Swab post vaccination on 20Dec2020 with test result Negative. Therapeutic measure Cardiac cath procedure was taken as a result of myocardial infarction. The outcome of the event was recovering. This case was reported as Serious with seriousness criteria hospitalization.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported myocardial infarction and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association. However, more information is required, such as the complete medical history, clinical course, for the Company to make a more meaningful causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,12/16/2020,12/19/2020,3.0,PVT,,,Medical History/Concurrent Conditions: Arthritis; Sulfonamide allergy,,,"['Catheterisation cardiac', 'Myocardial infarction', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 944255,UT,25.0,F,"Rash over all over body, started at neck.; itching; This is a spontaneous report from a contactable Nurse. A 25-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246, expiry date: unknown), intramuscular on 06Jan2021 15:15 at single dose (Left arm) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Facility type vaccine was Clinic/Facility. The patient experienced rash over all over body, started at neck and also complained of itching on 06Jan2021 15:30. Patient denied breathing difficulties. EMTs arrived and gave client oxygen and Benadryl. AE resulted in Emergency room/department or urgent care. It was unknown if patient had COVID prior vaccination. The patient was not tested for COVID post vaccination. Therapeutic measures were taken as a result of rash over all over body, started at neck and itching. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal association, the Company considers the events rash and pruritus are possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,,,,,,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH,OT 944257,CA,41.0,F,"took a rapid test and it came up positive; took a rapid test and it came up positive; fever 100.8; coughing; This is a spontaneous report from a contactable consumer (patient herself). A 41-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, reported as Pfizer covid19 el1284), via an unspecified route of administration on 30Dec2020 14:30 in left arm at single dose for covid-19 immunisation. Medical history included asthma and arthritis. Concomitant medication included ibuprofen and paracetamol (TYLENOL). The most recent COVID-19 vaccine was administered in public health clinic/ veterans administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Patient got the vaccine on Wednesday 30Dec2020, and by Saturday (02Jan2021 22:30) she started with a little coughing that increase on Monday (04Jan2021), Monday afternoon she had fever 100.8. She thought she was experiencing side effects and reported to her supervisor and didn't work the 2 next days. She when back to work on Thursday (07Jan2021), she was sent to a covid clinic and took a rapid test and it came up positive. The patient underwent lab tests and procedures which included nasal swab (rapid antigen testing - SARS-CoV-2): positive on 07Jan2021. The events were reported as non-serious. No treatment was received for the events. Outcome of events were recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,PUB,; TYLENOL,,Medical History/Concurrent Conditions: Arthritis; Asthma,,,"['Cough', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 944259,AZ,53.0,F,"diebities; overweight; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date t a single dose for COVID-19 immunization. Medical history included 'dibeities'. The patient's concomitant medications were not reported. The patient experienced 'diebities' and was overweight on an unspecified date with outcome of unknown. The patient was not tested for COVID-19 post vaccination. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Diabetes,,,['Overweight'],UNK,PFIZER\BIONTECH, 944264,,45.0,M,"Received the first dose of the COVID Vaccine on 29Dec2020 and tested positive for COVID on 08Jan2021; Received the first dose of the COVID Vaccine on 29Dec2020 and tested positive for COVID on 08Jan2021; This is a spontaneous report from a non-contactable consumer. A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of the COVID Vaccine on 29Dec2020 and tested positive for COVID (Nasal Swab) on 08Jan2021. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/08/2021,10.0,PVT,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 944267,VA,,F,"12/31-mild facial weakness left forehead, left cheek/smile asymmetry.; 12/30-headache, left ear pain, left face pain/continued numbness tingling; 12/30-headache, left ear pain, left face pain/continued numbness tingling; 12/30-headache, left ear pain, left face pain/continued numbness tingling; 12/30-headache, left ear pain, left face pain/continued numbness tingling; 12/29-+fatigue, SOB, left sided lowback pain - severe; 12/29-+fatigue, SOB, left sided lowback pain - severe; 12/29-+fatigue, SOB, left sided lowback pain - severe; 19:00- chills, myalgias, cold sensation of b/l feet; 19:00- chills; 19:00- chills, myalgias; At 16:00- palpitations; At 16:00- palpitations, chest tightness; At 12:00 (within 4 hrs) began experiencing L sided facial and Left foot numbness/tingling and left hand.; Reported to health care provider, began steroids for early onset bell's palsy; This is a spontaneous report from a contactable other health professional (patient). An adult female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL1284 via intramuscular in left arm on 28Dec2020 08:30 at single dose for COVID-19 immunization. Medical history included Crohns, asthma, migraine, GERD (gastrooesophageal reflux disease), Known Allergies: pyridium. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Concomitant medication included mesalazine (PENTASA), famotidine (PEPCID), paracetamol (TYLENOL), calcium phosphate, colecalciferol (VITAFUSION CALCIUM), ascorbic acid, biotin, calcium, choline bitartrate, chromium, copper, folic acid, inositol, iodine, iron, magnesium, manganese, molybdenum, nicotinamide, pantothenic acid, phosphorus, potassium, pyridoxine, retinol, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos, vitamin d nos, zinc (MULTIVITAMIN) , biotin, colecalciferol (VITAMIN D). Reported Event: on 28Dec2020 at 12:00 (within 4 hrs) began experiencing L sided facial and Left foot numbness/tingling and left hand. At 16:00- palpitations, chest tightness. 19:00- chills, myalgias, cold sensation of b/l feet. 12/29-+fatigue, SOB, left sided low back pain - severe. 12/30-headache, left ear pain, left face pain/continued numbness tingling. 12/31-mild facial weakness left forehead, left cheek/smile asymmetry. Reported to health care provider, began steroids for early onset bell's palsy. On 08Jan2021 continue to have paresthesia of my left face, left hand, left foot, headache, mild left facial weakness/altered sensation. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment received for the adverse events on 01Jan2021. The outcome of the events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bell's palsy /facial paresis cannot be fully excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/01/2020,,PVT,PENTASA; PEPCID [FAMOTIDINE]; TYLENOL; VITAFUSION CALCIUM; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM;CHOLINE BITARTRATE;CHROMIUM;COPPER;FOLIC ACID;INOSITOL;IO; ; VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: Asthma; Crohns associated arthritis; Drug allergy; GERD; Migraine,,,"['Back pain', 'Chest discomfort', 'Chills', 'Dyspnoea', 'Ear pain', 'Facial asymmetry', 'Facial pain', 'Facial paralysis', 'Facial paresis', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Myalgia', 'Palpitations', 'Paraesthesia', 'Peripheral coldness', 'Sensory disturbance']",1,PFIZER\BIONTECH,OT 944269,CA,,F,"Bell's palsy; Loss of taste; Can not close one eye, no muscle movement on one side of the face.; This is a spontaneous report from a contactable nurse. An adult female (not pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 05Jan2021 15:30 at single dose for COVID-19 immunization. There were no medical history or concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient experienced Half face paralysis, Bell's palsy. Loss of taste. Can not close one eye, no muscle movement on one side of the face. All on 08Jan2021 14:30 with outcome of unknown. No treatment was received.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of Half face paralysis/Bell's palsy cannot be fully excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/08/2021,3.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Ageusia', 'Eyelid function disorder', 'Facial paralysis']",1,PFIZER\BIONTECH,OT 944270,MA,58.0,M,"He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effect.; Rt basal ganglia hemorrhage w/ edema and mass effect.; Low platelets, 114; His bp as high as 200s/100; Hand weakness; Myalgia; Fever; Severe fatigue; This is a spontaneous report from a contactable physician. A 58-year-old male patient received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine), intramuscularly on 16Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension with reported med noncompliance in the last few months due to stress. Concomitant medication included hypertension medications in two weeks. The patient was presumed neg covid status prior to vaccine. He worked as a Pulm/critical care physician. He reported fever, myalgia, fatigue on 16Dec2020. Next day (17Dec2020), he took off from work due to his symptoms. The following day (18Dec2020), he came to work. He c/o ongoing severe fatigue & hand weakness in am. Staff noted him to be evaluating his hands during clinic. At 12:15, he collapsed with left sided hemiparesis. The reporter had suspicion for stroke. He was transported to the Emergency Room (ER), head CT showed Rt basal ganglia hemorrhage w/ edema and mass effect. Labs notable for Low platelets, 114 (unknown baseline) on 18Dec2020, normal coags on an unspecified date. BP recorded as 179/101, but it was noted in trauma room his bp as high as 200s/100. He had a history of hypertension with reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was unknown but had rebleed there with low plts. Adverse event (he collapsed with left sided hemiparesis) resulted in hospitalization (22 days), life threatening illness (immediate risk of death from the event), disability/incapacitating or permanent damage. Treatment was received for adverse events. Results of tests and procedures for investigation of the patient: on 18Dec2020, Nasal Swab test: negative. The outcome of events was not recovered. Unknown if any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Collapsed with left sided hemiparesis/suspicion for stroke are as consequences of basal ganglia hemorrhage with edema, which is caused by worsening of hypertension. Low platelet also contributes to brain hemorrhage. All these serious events are unrelated to the vaccine use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,22.0,Yes,N,12/16/2020,12/16/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Hypertension; Stress,,,"['Basal ganglia haemorrhage', 'Blood pressure increased', 'Brain oedema', 'Cerebrovascular accident', 'Coagulation test normal', 'Computerised tomogram head abnormal', 'Culture negative', 'Fatigue', 'Hemiparesis', 'Impaired work ability', 'Intracranial mass', 'Muscular weakness', 'Myalgia', 'Platelet count decreased', 'Pyrexia', 'Syncope']",1,PFIZER\BIONTECH,OT 944272,TX,35.0,F,"Sore throat, severe chest tightness and pressure, very hard to breathe in, more than 30 minutes after covid vaccine, dizziness, headache, lightheadedness; severe chest tightness and pressure; very hard to breathe in, more than 30 minutes after covid vaccine; Dizziness /lightheadedness; headache; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration at left arm on 09Jan2021 10:30 at single dose for COVID-19 immunization at a hospital. The patient's medical history included migraines, asthma, diabetes, sleep apnea, low immune system, post-traumatic stress disorder (PTSD), depression, panic attacks, insomnia, borderline personality disorder, and known allergies to medications, food, or other product (10 total). Concomitant medications included adult tetanus vaccine on 04Jan2021 received at right arm, for immunization (within 4 weeks prior to the COVID vaccine); first dose of botulinum toxin type a (BOTOX) on 06Jan2021 at single (31 shots in 7 muscle groups) for migraines (within 4 weeks prior to the COVID vaccine); and clindamycin antibiotic for infection in finger (took within in two weeks). The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination. On 09Jan2021 11:00, the patient experienced sore throat, severe chest tightness and pressure, very hard to breathe in, more than 30 minutes after COVID vaccine, ""dizziness/lightheadedness"", and headache. The above mentioned events resulted in emergency room/department or urgent care visit, and patient received breathing treatment, oxygen for over an hour for these events. The outcome of the events was unknown. The reporter considered the events as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,BOTOX;,,"Medical History/Concurrent Conditions: Asthma; Borderline personality disorder; Depression; Diabetes; Immune system disorder; Insomnia; Migraine; Multiple allergies (known allergies to medications, food, or other product (10 total)); Panic attacks; Post-traumatic stress disorder; Sleep apnea",,,"['Chest discomfort', 'Dizziness', 'Dyspnoea', 'Headache', 'Oropharyngeal pain']",1,PFIZER\BIONTECH, 944275,MI,72.0,M,"complete hearing loss at the right ear, 5 hours post injection, continued till now 3 days past injection, not resolved yet prior to report; This is a spontaneous report from a contactable physician. A 72-years-old male patient started to receive bnt162b2 (BNT162B2) Lot number# ek9231 intramuscularly on 06Jan2021 12:00 at single dose for covid-19 immunisation. Anatomical Location: Arm Right. Facility where the most recent COVID-19 vaccine was administered: Hospital. Medical history included diabetes mellitus, hypertension. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included alprazolam (AZOR [ALPRAZOLAM]), metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE MONOHYDRATE]), atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]). The patient on 06Jan2021 18:00 reported complete hearing loss at the right ear, 5 hours post injection, continued till now 3 days past injection, not resolved yet prior to report. The action taken was not applicable.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported hearing loss cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,AZOR [ALPRAZOLAM]; JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE MONOHYDRATE]; LIPITOR [ATORVASTATIN CALCIUM],,Medical History/Concurrent Conditions: Blood pressure high; Diabetes,,,"['Deafness', 'Deafness unilateral']",1,PFIZER\BIONTECH,OT 944277,HI,45.0,F,"Allergic reaction to vaccine; tingling to upper lip and face; tingling to upper lip and face; red rash on bilateral forearms; Patient developed Bell's Palsy 2-3 days later; This is a spontaneous report from a contactable consumer. A 45-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration on 23Dec2020 at 14:30 at single dose in left arm for covid-19 immunization. Medical history included mitral valve prolapse from an unknown date, and allergies: Cephalosporins and nut (peanut derived). Concomitant medication included epinephrine (EPIPEN) 0.3MG/0.3ML, fluticasone propionate 50MCG/ACT nasal spray. On 23Dec2020 at 14:45, the patient experienced allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms. Reactions resolved with no treatment. The patient developed Bell's Palsy 2-3 days later in Dec2020. Currently being treated with high dose steroids and acyclovir. All events required emergency room visit and physician office visit. All events were reported as non-serious by reporter. The outcome of event Bell's Palsy was not resolved, outcome of other events was resolved on an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination, and it was unknown if the patient has been tested for COVID-19 since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/01/2020,,PVT,EPIPEN;,,Medical History/Concurrent Conditions: Allergic reaction to antibiotics; Mitral valve prolapse; Peanut allergy,,,"['Facial paralysis', 'Hypersensitivity', 'Paraesthesia', 'Paraesthesia oral', 'Rash', 'Rash erythematous']",1,PFIZER\BIONTECH, 944279,NH,27.0,F,"fever and chills; fever and chills; blood pressure was low, about 90/50; did not feel well; syncope episode; unconscious; This is a spontaneous report from a contactable other health professional. A 27-year-old non-pregnant female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration in the left arm on 08Jan2021 at 12:00 at a single dose for COVID-19 immunization; received at a nursing home/senior living facility. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Medical history included COVID-19 from an unknown date and unknown if ongoing. No known allergies. Concomitant medications included unspecified birth control taken for an unspecified indication from an unknown date to an unknown date; within two weeks of vaccination. The patient experienced the following events and outcomes: syncope episode in Jan2021 with outcome of unknown, unconscious in Jan2021 with outcome of unknown, fever and chills on 09Jan2021 with outcome of unknown, blood pressure was low, about 90/50 on 09Jan2021 with outcome of unknown, did not feel well in Jan2021 with outcome of unknown; all of which were assessed as medically significant. The clinical course was reported as follows: the fever and chills began about one hour after vaccination (as reported). About 18 hours after the vaccination, the patient was getting up to take more paracetamol (TYLENOL) and did not feel well. The patient had a syncope episode in the bathroom (no issues as she sat on the floor before hand). The patient was unconscious for about 1-2 minutes. The patient's blood pressure several minutes later was low, about 90/50; however, the patient took the blood pressure measurement herself, so it may not have been exactly accurate. The patient underwent lab tests and procedures which included blood pressure measurement: low, about 90/50 on 09Jan2021. Therapeutic measures were taken as a result of fever. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all reported serious events cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/01/2021,,OTH,,,Medical History/Concurrent Conditions: COVID-19,,,"['Chills', 'Hypotension', 'Loss of consciousness', 'Malaise', 'Pyrexia', 'Syncope']",1,PFIZER\BIONTECH, 944280,IL,25.0,F,"Heart rate shot up to 170 with numbness of feet.; Heart rate shot up to 170 with numbness of feet.; Chest pain; feeling like I was going to vomit and faint; feeling like I was going to vomit and faint; This is a spontaneous report from a contactable other hcp (patient). A 25-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at 11:45 at single dose in left arm for covid-19 immunization. There was no medical history. Concomitant medication included valaciclovir hydrochloride (VALTREX), topiramate (TOPAMAX), lamotrigine (LAMICTAL), duloxetine hydrochloride (CYMBALTA), ziprasidone hydrochloride (GEODON). On 06Jan2021 at 12:30, The patient experienced heart rate shot up to 170 with numbness of feet, started to feel chest pain, and feeling like she was going to vomit and faint. The events required emergency room visit and were reported as serious per hospitalization. Heart rate at the hospital was 135-140 where two EKG were done and fluids were given. An x-ray of the heart was done and blood work was completed. The patient didn't receive treatment for the events. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and has not been tested for COVID-19 since the vaccination. The outcome of the events was resolved in Jan2021. Information on batch/lot number has been requested.; Sender's Comments: There is a reasonable possibility that the event ""feeling like she was going to vomit"" was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported serious events with BNT 162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,VALTREX; TOPAMAX; LAMICTAL; CYMBALTA; GEODON [ZIPRASIDONE HYDROCHLORIDE],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Blood test', 'Chest X-ray', 'Chest pain', 'Dizziness', 'Electrocardiogram', 'Heart rate increased', 'Hypoaesthesia', 'Nausea']",1,PFIZER\BIONTECH, 944282,NY,70.0,M,"resident coded on 09Jan at 8am and expired; This is a spontaneous report from a contactable Other Health Professional. A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly in left arm on 05Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included DM2(Type two diabetes mellitus), CHF(congestive heart failure), open wound, wound infection, heart failure. Allergies to medications, food, or other products: none. Concomitant medications included unspecified products (List of any other medications the patient received within 2 weeks of vaccination: yes). If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. The resident coded on 09Jan2021 at 8 AM and expired. The patient died on 09Jan2021. An autopsy was not performed. AE resulted in: patient died. Death cause: unknown at this time. Was treatment received for the adverse event: Unknown. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Serious: Yes. Seriousness criteria-Results in death: Yes. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.; Sender's Comments: The old patient had diabetes mellitus, congestive heart failure, open wound complicated by infection, all these pre-existing medical conditions contribute to the patient death. More information including complete medical history, concomitant medications and event term details especially death cause and autopsy results are needed for a full assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: resident coded on 09Jan at 8am and expired",Yes,01/09/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/09/2021,4.0,OTH,,,Medical History/Concurrent Conditions: Congestive heart failure; Heart failure; Open wound; Type 2 diabetes mellitus; Wound infection,,,"['Cardio-respiratory arrest', 'Death']",1,PFIZER\BIONTECH,OT 944283,IL,34.0,F,"Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Sunday had emergency appendectomy for actuate appendicitis.; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Post surgery had allergic reaction unknown reason with head to toe rash; Post surgery had allergic reaction unknown reason with head to toe rash; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular (lot number: EL1283) on left arm on 08Jan2021 at 6:30 AM at single dose for covid-19 immunisation. The relevant medical history included celiac, anemia, known allergies: Sulfa and Gluten. Concomitant medications were not reported. The patient received first dose of BNT162B2 via intramuscular (lot number: Ek5730) on left leg on 18Dec2020 at 11:00 AM at single dose for covid-19 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat. On Saturday the patient had sweating, chills, headache, nausea. On Sunday had emergency appendectomy for actuate appendicitis. Post surgery had allergic reaction unknown reason with head to toe rash. It was also reported that the adverse event started on 08Jan2021 at 03: 15 PM (as reported). The patient had 1-day hospitalization. The patient received treatment for the events. The adverse events resulted in Emergency room/department or urgent care. The events were reported as serious due to life threatening and hospitalization. The most recent COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. Medications administered during appendectomy may confound reactions experienced post-surgery. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Yes,Yes,1.0,Not Reported,N,01/08/2021,01/01/2021,,PVT,,,Medical History/Concurrent Conditions: Anemia; Celiac disease; Gluten sensitivity (known allergies); Sulfonamide allergy (known allergies),,,"['Appendicectomy', 'Appendicitis', 'Chills', 'Headache', 'Hyperhidrosis', 'Hypersensitivity', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Nausea', 'Paraesthesia', 'Paraesthesia oral', 'Pharyngeal hypoaesthesia', 'Pharyngeal paraesthesia', 'Rash']",2,PFIZER\BIONTECH,OT 944285,,,F,"passing out sensation; heart palpitations; sweating; diarrhea; This is a spontaneous report from a contactable consumer (patient's boyfriend). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter reported that symptoms were related to the use of Covid 19 vaccine. The patient received the first dose on 15Jan (as reported) and the day after developed sweating, passing out sensation, heart palpitations and this morning on 11Jan2021 when she woke up she had the same symptoms plus diarrhea. The outcome of the events was unknown. Information on the lot number/batch number was requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/11/2021,,UNK,,,,,,"['Diarrhoea', 'Dizziness', 'Hyperhidrosis', 'Palpitations']",1,PFIZER\BIONTECH, 944286,AZ,,F,"severe hypertension (190/100); flushing tachycardia; flushing tachycardia; blurred vision in the left eye; This is a spontaneous report from a contactable healthcare professional reporting for self. This 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. Medical history included ongoing underlying HTN (hypertension). Concomitant medications were not reported. The patient experienced AE following administration of first dose of vaccine of including: severe hypertension (190/100), flushing tachycardia, and blurred vision in the left eye. These symptoms started 20minutes after administration. The patient stated her PCP thought that she had underlying hypertension and had since started her on medications. She was looking for guidance with regard to receiving the second dose. The outcome of events was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: The administration of BNT162B2 might have played a contributory role in triggering the onset of serious event hypertension worsened, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,Hypertension,,,,"['Flushing', 'Hypertension', 'Tachycardia', 'Vision blurred']",1,PFIZER\BIONTECH, 944287,MO,66.0,M,"he was in AFIB for about 3 hours after receiving his first dose of the COVID19 Vaccine; he noticed the rest of the day, right up to going to bed that he felt cold; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1284) at arm, left upper, via an unspecified route of administration on 29Dec2020 06:15 at single dose for covid-19 immunisation. Medical history included atrial fibrillation (Afib) formally diagnosed around Jan2020. There were no concomitant medications. The patient reported he got the COVID-19 Vaccine at 06:15 on 29Dec2020 and had to sit for 15 minutes afterwards before he could leave. He said everything was fine, and he walked out to the hospital lobby, and was speaking with a work associate for 10 minutes before he headed to his car. When he got ready to leave, he got in his car, and started his car. He started driving home, and realized he was in AFIB. He did have an AFIB issue. His AFIB has been pretty well controlled for a year now, as long as, he didn't do something stupid. He had a moderately aggressive run of AFIB. He said his ""smart"" watch told him his heart rate was 117. His normal heart rate is around 60-70. He was in AFIB for about 3 hours. His typical runs of AFIB are considerably shorter. He only had a total of 2 episodes of AFIB in the last year. His prior AFIB episodes would have been about 4-5 minutes. The last time he had AFIB that lasted any length of time was when he was hospitalized for AFIB around Jan2020. He said at that time, he was hospitalized overnight for observation. He received medication during the hospitalization and his AFIB broke. He didn't remember what medications were given to him during the hospitalization. He said he had flutters before that hospitalization, but the flutters were always gone after a few minutes, so he never sought treatment because there would be nothing to treat. The patient reported he noticed the rest of the day on 29Dec2020, right up to going to bed that he felt cold. His house wasn't cold, and he didn't have a fever. He said the cold feeling went away during the night while he was sleeping. He said the cold feeling easily lasted for a 12 hours. He said the cold feeling could have been something else. The outcome of ""he was in afib for about 3 hours after receiving his first dose of the covid19 vaccine"" was recovered on 29Dec2020; of ""he noticed the rest of the day, right up to going to bed that he felt cold"" was recovered on 30Dec2020.",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,,Medical History/Concurrent Conditions: AFib (formally diagnosed around Jan2020),,,"['Atrial fibrillation', 'Condition aggravated', 'Feeling cold', 'Heart rate increased']",1,PFIZER\BIONTECH, 944289,NJ,22.0,F,"she was diagnosed with bilateral deep vein thrombosis (DVT) and pulmonary embolism (PE); she was diagnosed with bilateral deep vein thrombosis (DVT) and pulmonary embolism (PE); This is a spontaneous report from a contactable nurse (patient). A 22-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration in left arm on 06Jan2021 13:45 at single dose for COVID-19 immunisation. Medical history included allergy to all fish, and clots. The patient was not pregnant. There were no concomitant medications. The patient previously received 1st dose of BNT162B2 (lot numer: EH9899) in left arm on 16Dec2020 13:45 for COVID-19 immunisation and experienced left sided lower back pain on 20Dec2020. No other vaccine received in four weeks. It was reported that the patient had the first covid vaccine on 16Dec2020 and on 20Dec2020 started with left sided lower back pain and then received the second on 06Jan2021 and then on 09Jan2021 11:00 her legs became blue and swollen and she was diagnosed with bilateral deep vein thrombosis (DVT) and pulmonary embolism (PE). The patient otherwise healthy and had never had covid. Other than the clots, she had no other health issues. The patient underwent lab tests and procedures which included nasal swab: negative on 09Jan2021. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and life threatening illness (immediate risk of death from the event), hospitalized for 2 days (in Jan2021). Adverse event treatment: heparin drip and xarelto at home. Recovered with lasting effects on an unspecified date of Jan2020. This case was reported as serious, serious criteria was life threatening, caused/prolonged hospitalization.; Sender's Comments: The underlying risk factors/predisposing condition of thrombotic diathesis have been assessed to have played a contributory role toward the events.",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/06/2021,01/09/2021,3.0,PVT,,,Medical History/Concurrent Conditions: Clot blood; Fish allergy,,,"['Condition aggravated', 'Culture negative', 'Cyanosis', 'Deep vein thrombosis', 'Peripheral swelling', 'Pulmonary embolism']",2,PFIZER\BIONTECH, 944365,KY,76.0,M,"Resident expired on 12/30/20, dx cardiac arrest.",Yes,12/30/2020,Not Reported,Not Reported,,Not Reported,N,12/26/2020,12/30/2020,4.0,SEN,"Diazepam, Levothyroxine, Magnesium Oxide, Olanzapine, Omeprazole, Sertraline, and Vitamin D3",None,Schziophrenia,,,"['Cardiac arrest', 'Death']",1,PFIZER\BIONTECH,IM 944369,CO,43.0,U,"tried, achy, bump on arm, stuffed up",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/27/2020,1.0,PVT,,,,,,"['Fatigue', 'Pain', 'Peripheral swelling']",1,MODERNA,IM 944374,ID,60.0,F,"Within 15 min of admin; pt reported feeling super drowsy and complained of Headache. She was given water and Acetaminophen, 25mg of Diphenhydramine. BP 140/64 Pulse 74",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/14/2021,0.0,OTH,,,"Allergies: Ascorbic Acid, Fish, Aspirin, Lactose, Azapetine, Latex, Bee Venom (honey bee), Natural Robber, Cinnomon, Milk, Ciprofloxacin, Morphine, Cocoa, Opioids, Codeine, Morphine Amalogues, Divalproex Dodium, Pear tree, Doxycycline, Penicillins, Ephedrine, Sulfasalazine, Erythromycin, Lettuce, - Staff Reports that she sleeps a lot normally",,,"['Headache', 'Somnolence']",1,PFIZER\BIONTECH, 944379,,54.0,F,Cellulitis at injection site. Gotten worse. 1/11/21 measured site. 70x80mm. Itching around site.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Injection site cellulitis', 'Injection site pruritus']",1,MODERNA,IM 944439,KY,62.0,F,Resident expired on 1/2/21.,Yes,01/03/2021,Not Reported,Not Reported,,Not Reported,N,12/26/2020,01/03/2021,8.0,SEN,"Keppra, Levothyroxine, Miralax, Olanzapine, Trazadone, Risperidone, and Lorazepam",Receiving hospice services,Stage 4 kidney function,,,['Death'],1,PFIZER\BIONTECH,IM 944450,MA,26.0,F,"Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observation area at this time. At 1530, EE returned to vaccination room to alert staff of her reaction. Upon hearing her new onset cough, an assessment was performed immediately. Reported tingling and swelling of her lips, cough, minor difficulty breathing with mask on, facial flushing and feeling hot, and severe pruritus, especially on the scalp. 50 mg IM Benadryl administered and was taken to ED via wheelchair which is 7 minutes away. Epi Pen administered in ED and admitted overnight for observation d/t irregular HR and ST depression on monitor.",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/13/2021,01/13/2021,0.0,WRK,Cymbalta,"Fioricet - Hives Mushrooms & pineapple - swollen lips, cough, hives Flu vaccine - had lip swelling and hives at injection site x 1 on 10/8/20 after receiving flu vaccine this year at Hospital. Has had flu vaccine annually prior to 2020 through the hospital without issues.","2018-2019 herniated discs in neck. Resolved with physical therapy. 2007 appendectomy; pneumonia in childhood Sports sports induced asthma, well controlled, no daily meds, no inhaler.","Flu vaccine administered on 10/7/20 at Medical Center to (r) deltoid. Lot # UJ427AC, manufacturer Fluzone. Reportedly develop",,"['Cough', 'Dyspnoea', 'Electrocardiogram ST segment depression', 'Feeling hot', 'Flushing', 'Heart rate irregular', 'Lip swelling', 'Paraesthesia oral', 'Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,IM 944459,CA,29.0,F,"-swollen tongue , unable to swallow , able to breath Tx - antihistamines and steroids.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"VitC, B12, D3, Nuturia (herbal supplements) Apri (BCP)",none,none,,NKA,"['Dysphagia', 'Swollen tongue']",1,MODERNA, 944506,TX,,U,"occipital lobe stroke; postherpetic neuralgia; vision problems and balance issues; vision problems and balance issues; herpes zoster; This initial spontaneous report was received from a lawyer on 08-JAN-2021, regarding a case in litigation and refers to a currently 72-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 28-MAY-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot# and dosage regimen information was not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for a provider for the following injuries: herpes zoster, postherpetic neuralgia, occipital lobe stroke, vision problems and balance issues. At the time of the report, the outcome of cerebrovascular accident, herpes zoster, balance disorder, visual impairment and post herpetic neuralgia was unknown. The reporter considered that herpes zoster, postherpetic neuralgia, occipital lobe stroke, vision problems and balance issues were related to zoster vaccine live (ZOSTAVAX). Upon internal review, occipital lobe stroke was considered to be medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,05/28/2015,,,PHM,,,,,,"['Balance disorder', 'Cerebrovascular accident', 'Herpes zoster', 'Post herpetic neuralgia', 'Visual impairment']",UNK,MERCK & CO. INC., 944507,NV,46.0,M,"Loss of vision; Possible lowgrade central retinal occlusion; retinal venous dilation; Decreased vision; Unexplained Retinal Hemorrhages; A spontaneous report was received from an ophthalmologist retinal specialist concerning a 46-year-old, male patient who received Moderna's COVID-19 Vaccine and developed loss of vision, decreased vision, unexplained retinal hemorrhages, retinal venous dilation, and possible low grade central retinal occlusion. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 23 Dec 2020, approximately four days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 27 Dec 2020, the patient experienced decreased vision. On 29 Dec 2020, the physician examined the patient. There was some retinal hemorrhage, venous dilation, and possible low grade central retinal occlusion. Lab work was requested by the physician and results were pending. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, loss of vision, decreased vision, unexplained retinal hemorrhages, retinal venous dilation, and possible low grade central retinal occlusion were unknown.; Reporter's Comments: This case concerns a 46 year old male patient. The patient's medical history is not provided. The patient experienced a serious, unexpected event of loss of vision, unexplained retinal hemorrhages, retinal venous dilation, and possible low grade central retinal occlusion. The event occurred 4 days after first dose of the mRNA-1273. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of mRNA-1273 and the event, a causal relationship cannot be excluded. Additional information are required for further assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/27/2020,4.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Blindness', 'Retinal haemorrhage', 'Retinal vascular occlusion', 'Visual impairment']",1,UNKNOWN MANUFACTURER,OT 944508,FL,56.0,F,"Anaphylactic shock; feeling some stuff in my throat; A spontaneous report was received from a 56-year-old, female nurse, who was also the patient, who received Moderna's COVID-19 vaccine and experienced anaphylactic shock and feeling some stuff in my throat. The patient's medical history included having general allergies. Concomitant product use was not provided by the reporter. On 28 Dec 2020, immediately prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 28 Dec 2020, while the vaccination needle was being pulled out of the patient's arm, the patient experienced anaphylactic shock. Two epinephrine injections were used within ten minutes of the reaction. The patient continued to take steroids due to her still feeling some stuff in her throat at the time of reporting. Treatment for the events included two epinephrine injections and steroids. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, anaphylactic shock, was unknown. The event, feeling some stuff in my throat, was considered not resolved.; Reporter's Comments: This case concerns a 56-year-old female patient with medical history of unspecified allergies requiring Epi-pen, who received their first of two planned doses of mRNA-1273 (Lot 025J20A), and who experienced a serious unlisted event of Anaphylactic shock and a non-serious unlisted event of Oropharyngeal discomfort immediately following vaccination. Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. The patient's history of general allergies requiring Epi-pen remain as confounders.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,UNK,,Allergy,,,,"['Anaphylactic shock', 'Immediate post-injection reaction', 'Oropharyngeal discomfort']",1,UNKNOWN MANUFACTURER,OT 944509,OH,40.0,F,"Vaccine was administered in shoulder and seemed kind of high; shot felt strange going in; can't move or lift arm at all; Nicked nerve; left shoulder much lower than the right; level of pain was a 10 out of 10 a few hours later; A spontaneous report was received from a 40-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, vaccine was administered in should and seemed kind of high, shot felt strange going in, can't move or lift arm at all, nicked nerve, left shoulder much lower than the right, and level of pain was 10 out of 10 a few hours later. The patient's medical history was not provided. Concomitant product use reported included vitamins, bupropion and trazadone. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 29 Dec 2020, the patient reported that the vaccine was administered in her left shoulder but that it seemed kind of high. The patient mentioned to the nurse giving her the vaccine that it felt strange going in and that it did not feel like a normal injection. A few hours later, she stated that her pain level was 10/10. On 30 Dec 2020, she followed up with her primary physician and was instructed to go to urgent care the next day if she did not feel any better. On 31 Dec 2020, patient reported that she literally could not move or lift her left arm at all and had to use her right arm to lift it due to the pain. She also stated that her left shoulder was much lower than the right. On that same day, she went to an orthopedic urgent care where she was told that the vaccine had potentially nicked a nerve causing the issues in her arm. However, without an MRI, the urgent care was unable to provide a definitive diagnosis. The patient was prescribed steroids and was told that she could not be referred for an MRI until the nerve became less agitated and inflamed once the steroids took effect, in approximately one week. Treatment for the event included oral steroids. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, vaccine was administered in should and seemed kind of high, shot felt strange going in, can't move or lift arm at all, nicked nerve, left shoulder much lower than the right, and level of pain was 10 out of 10 a few hours later, was not reported.; Reporter's Comments: This case concerns a 40-year-old female patient who experienced the events of vaccine was administered in should and seemed kind of high, shot felt strange going in, can't move or lift arm at all, nicked nerve, left shoulder much lower than the right, and level of pain was 10 out of 10 a few hours later. The event of shot felt strange going in occurred on the same day when the product was administered, and the events of can't move or lift arm at all, nicked nerve, left shoulder much lower than the right, and level of pain was 10 out of 10 a few hours later occurred within 2 days following administration of the first dose of mRNA-1273, Lot #039K20A. Based on the limited available information, a definitive assessment with regards to a drug: event-causal association cannot be provided at this time. However, due to the temporal association between the onset of the event and the administration of the drug, a causal relationship cannot be excluded. Hence, the events of shot felt strange going in, can't move or lift arm at all, nicked nerve, left shoulder much lower than the right, and level of pain was 10 out of 10 a few hours later are assessed as possibly related to mRNA-1273. The event of vaccine was administered in should and seemed kind of high is a procedural issue and assessed as not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,UNK,TRAZODONE; WELLBUTRIN; VITAMINS NOS,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Administration site nerve damage', 'Injected limb mobility decreased', 'Injection site discomfort', 'Injection site pain', 'Nerve injury', 'Product administered at inappropriate site', 'Shoulder deformity']",1,UNKNOWN MANUFACTURER,OT 944510,NV,50.0,F,"Symptoms like an allergic reaction; Flu like symptoms; Tiredness in her muscles; Shortness of breath (she feels it in her chest); Skin is itchy and feels as if she had a rash; A spontaneous report was received from a 50 year-old female patient, who received Moderna's COVID-19 Vaccine and experienced flu like symptoms, symptoms like an allergic reaction, tiredness in her muscles, shortness of breath (she feels it in her chest), and skin is itchy and feels as if she had a rash. The patient's medical history included allergies. No relevant concomitant medications were reported. On 30 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (batch number 025J20-2A) intramuscularly for COVID-19 for infection prophylaxis. On 30 Dec 2020, the patient received her first dose of the vaccine and later in the day she presented flu like symptoms and symptoms like an allergic reaction. She also reported she felt tiredness in her muscles, shortness of breath (she feels it in her chest), her skin is itchy and feels as if she had a rash but she didn't have a rash. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, symptoms like an allergic reaction, tiredness in her muscles, shortness of breath (she feels it in her chest), and skin is itchy and feels as if she had a rash, was considered not resolved.; Reporter's Comments: This case concerns a 50 year old female patient with medical history of allergies, who experienced a serious unexpected event of Hypersensitivity and NS unexpected events of Influenza like illness, Muscular weakness, Dyspnoea, and Pruritus. The events occurred on the same day when the patient received the first of two planned doses of mRNA-1273 (batch number 025J20-2A). Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PUB,,,Medical History/Concurrent Conditions: Allergy NOS (history of allergies),,,"['Dyspnoea', 'Fatigue', 'Hypersensitivity', 'Influenza like illness', 'Muscle fatigue', 'Muscular weakness', 'Pruritus', 'Rash', 'Skin induration']",1,UNKNOWN MANUFACTURER,OT 944512,IL,39.0,F,"felt kind of tired; Tested positive for COVID after receiving the first dose of the COVID Vaccine; Tested positive for COVID after receiving the first dose of the COVID Vaccine; slight fever; body aches; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (the patient) reported that a 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730) via unspecified route of administration on the left arm/shoulder on 22Dec2020 at single dose for COVID-19 immunisation. Medical history included gained weight since the pandemic started. The patient's concomitant medications were not reported. Patient received first dose of the vaccine. She had symptoms right after she got the vaccine the next day, on 23Dec2020. She had a slight fever, body aches, and a headache, which she never gets. She had these for about 2-3 days, they lingered around, and kicked back up around 26Dec2020/27Dec2020. She also felt kind of tired. She got covid 19 infection tested on 02Jan2021 and the results came back positive on 03Jan2021. Patient was calling to report this and see what to do about the second dose. She was supposed to get her second dose next Tuesday. The outcome of events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/23/2020,1.0,UNK,,,Medical History/Concurrent Conditions: Weight increase,,,"['Fatigue', 'Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 944517,,44.0,F,"Myalgia chills, fatigue, syncope vs seizure 43 yo employee falt fatigue on 12/24 and again on 12/25/20. The patients husband reports she was walking down the stairs, seemed ""off"" and missed the step/slid on step injuring both feet/ankles. Pt got up and was able to stand for a few minutes. Husband reports that he than sat her on the steps-few minutes later she had syncope with convulsions vs seizure. Per his report this lasted over a minute, she stopped breathing and was unresponsive. He reports she was confused while he was on the phone with 911 operator (3 minutes). Patient was taken to Health Center for work up. The head CT, labs, X-rays, EKG were unremarkable. Followed up her physician Dr. and was referred to neurologist. She had a MRI without contrast which was unremarkable and is scheduled to undergo a sleep deprived EEG. She is undergoing physical therapy at this time for injury to bilateral feet/ankles.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/25/2020,2.0,OTH,,,,,,"['Chills', 'Computerised tomogram normal', 'Confusional state', 'Dyspnoea', 'Electrocardiogram normal', 'Fatigue', 'Feeling abnormal', 'Joint injury', 'Laboratory test normal', 'Limb injury', 'Magnetic resonance imaging abnormal', 'Myalgia', 'Seizure', 'Syncope', 'Unresponsive to stimuli', 'X-ray normal']",1,MODERNA,IM 944525,OH,,U,received the first dose of the vaccine on 21Dec2020 and tested positive for Covid-19; received the first dose of the vaccine on 21Dec2020 and tested positive for Covid-19; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date was not provided) via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 21Dec2020 and tested positive for covid-19 on 07Jan2021. The patient was isolated for 10 days. Outcome of event was unknown. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,01/07/2021,17.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 944526,TN,57.0,F,"COVID virus/on 29Dec2020 tested positive/symptoms of cough, chills, lost of taste and smell; COVID virus/on 29Dec2020 tested positive/symptoms of cough, chills, lost of taste and smell; This is a spontaneous report from a contactable other health professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EJ1685, expiration date: 31Mar2021), intramuscularly on 20Dec2020 17:43 at left deltoid, at single dose for vaccination. Medical history included asthma and diabetes. There were no concomitant medications. The patient received the first dose of vaccine on 20Dec2020. On 22Dec2020 she was exposed to Covid, on 28Dec2020 developed symptoms of cough, chills, lost of taste and smell, she had onset of COVID virus symptoms on 28Dec2020 with positive COVID result from COVID nasal swab test performed on 29Dec2020. She has already completed her Bamlanivimab infusion therapy to treat COVID virus on 31Dec2020. Her 2nd dose is due on 10Jan2020 and she wanted information on the use of antibody therapy with the Covid-19 vaccine. She asked if she should still get the second dose of Pfizer-BioNTech COVID-19 Vaccine as scheduled on 10Jan2021 relative to these events. She reported she still has COVID symptoms which have improved, but the symptoms she can't taste or smell are ongoing and persistent. Seriousness criteria: she thought it was serious but she was not injured or anything with it; she thought event was offset it by taking some medication and the Bamlanivimab infusion. In addition to Bamlanivimab infusion for treatment of the COVID virus she was also prescribed Azithromycin for 5 days started on 29Dec2020 which she completed; and Prednisone for 7 days started on 29Dec2020 which she stopped after 5 days of therapy because she did not like how it made her feel. The outcome of the event was recovering. Event relatedness between Pfizer-BioNTech COVID-19 Vaccine and COVID virus was unrelated.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/28/2020,8.0,UNK,,,Medical History/Concurrent Conditions: Asthma (Caller states she has asthma and diabetes.); Diabetes (Caller states she has asthma and diabetes.),,,"['Ageusia', 'Anosmia', 'Chills', 'Cough', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 944545,,,M,"positive COVID-19 test; positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable pharmacist. A around 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician reported that he knew the patient got the vaccine on 22Dec2020. On 02Jan2021, he tested positive to COVID-19. The outcome of the events was unknown. Information on the Lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (tested positive for COVID-19) with BNT162b2 can not be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,01/02/2021,11.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 944579,FL,68.0,F,Tufts of my hair came out by the handful - first time in my life I have experienced ANY hair loss! It is still ongoing and I am worried it will result in permanent baldness.,Not Reported,,Not Reported,Not Reported,,Yes,N,01/03/2021,01/05/2021,2.0,OTH,"normal OTC vitamins, same vitamins for the last 20 years",none,none,,None that I know of,"['Alopecia', 'Anxiety']",UNK,MODERNA, 944595,FL,56.0,M,Cardiac arrest within 1 hour Patient had the second vaccine approximately 2 pm on Tuesday Jan 12th He works at the extended care community and was in good health that morning with no complaints. He waited 10-15 minutes at the vaccine admin site and then told them he felt fine and was ready to get back to work. He then was found unresponsive at 3 pm within an hour of the 2nd vaccine. EMS called immediately worked on him 30 minutes in field then 30 minutes at ER was able to put him on life support yet deemed Brain dead 1-14-21 and pronounced dead an hour or so later,Yes,01/14/2021,Not Reported,Yes,2.0,Not Reported,N,01/12/2021,01/12/2021,0.0,SEN,"losartan, spironolactone, carvedilol","No known new illnesses,",Cardiomyopathy,,nkda,"['Brain death', 'Cardiac arrest', 'Death', 'Intensive care', 'Life support', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 944609,FL,75.0,M,He died nine hours later.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/13/2021,0.0,PUB,"Blood thinner, steroids, blood pressure meds",Diverticulitis,medicated high blood pressure,,None,['Death'],1,MODERNA,IM 944641,FL,83.0,F,Patient died on 1/21-2021,Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,OTH,"Atorvastatin 80mg daily, biotin 2500mg daily, Calcium-Mag-Zinc tab daily, Restasis eye drop q12hr, ezetimibe 10mg qhs, gabapentin 100mg bid, lysine 1000mg daily, metoprolol tart 50mg bid, fish oil 1000mg daily, prilosec 20mg daily, ranola","CAD, angina, coronary bypass in 1990's, Cardiac Cath on 12/28/2020",CAD,,Sulfa,['Death'],1,MODERNA,IM 944649,TX,33.0,F,"1/7/2021 @ 5:00 a.m. patient woke up and couldn't move her right side (neck, arm and leg). Sister helped dress her and drove her to the hospital. During the ride the hospital the patient had 2 seizures and a 3rd seizure in the ER at the hospital. Patient states she has never had multiple, back to back seizures before. States she hasn't had a seizure for 2 years. EEG was done. Was released from the hospital on 1/9/2021 and to have outpatient MRI of head, shoulder, c-spine. Does not have full range of motion of right neck, and arm, hand and fingers and is painful. 1/14/2021 - full release back to work on 1/14/2021.",Not Reported,,Not Reported,Yes,2.0,Not Reported,,01/06/2021,01/07/2021,1.0,UNK,,,"Epilepsy under control, no seizures for 2 years",,,"['Joint range of motion decreased', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Neck pain', 'Pain in extremity', 'Seizure']",1,MODERNA,IM 944663,KY,67.0,F,"Resident had been monitored and had shown no signs or symptoms of any kind until 2 pm on 1/14/2021. Resident was found in the floor of her room. She had fallen and was having a seizure, temperature was 99.7F and Oxygen saturation was 82%.",Not Reported,,Yes,Not Reported,,Not Reported,U,01/12/2021,01/14/2021,2.0,SEN,"Alendronate Sodium 70 mg, Diltiazem CD 120 MG daily, Hydrochlorothiazide 25 mg daily, Loratadine 10 mg daily, Multi Vitamin Daily, Pantoprazole SOD 40 mg Daily, Trazadone 50 mg at bedtime, CalCarb 600+D Daily, Fiber Lax tablets twice daily",None,"Resident has a history of convulsions/seizures, hypertension, and has an intellectual disability. She had a recent medication drug level on her Keppra and her Dilantin and both were within normal range.",,Resident is allergic to Tylenol and PCN,"['Body temperature increased', 'Condition aggravated', 'Fall', 'Seizure']",2,PFIZER\BIONTECH,IM 944665,NE,40.0,F,"Currently 32 weeks pregnant, delivery date of March 14,2021. The next morning I had a sore arm that lasted 2 days. A couple days of fatigue. I had on episode of vomiting, I believe it was the 12/31 or 1/1/.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,Labetalol-200mg BID Labutrin -450mg daily Cynthroid- 100mpg Prenatal,,Hypertension Hypothyroidism,,,"['Exposure during pregnancy', 'Fatigue', 'Pain in extremity', 'Vomiting']",1,PFIZER\BIONTECH,SYR 944732,WI,92.0,M,Resident found unresponsive and without pulse at 05:45am.,Yes,01/14/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,SEN,"Cholecalciferol, furosemide, metoprolol tartrate, tamsulosin, amlodipine, finasteride",Covid-19 infection from 12/31-01/10/2021,"CHF, atrial fibrilation, Dysphagia, macular degeneration, Vitamin D deficiency, impaired fasting glucose, benign prostatic hyperplasia, osteoporosis, retention of urine, anemia",,hydrocodone,"['Pulse absent', 'Unresponsive to stimuli']",1,MODERNA,IM 944782,KY,72.0,M,"on 1/14/21 patients HR 155 at 0800 per patient's home pulse ox device. arrived at ER, HR 148 at 1130. Continued to stay up even after 2 doses of 10mg iv push Cardizem and one dose of 30mg Cardizem. Cardizem drip started, heparin drip started, patient admitted to hospital",Not Reported,,Not Reported,Yes,,Not Reported,N,01/13/2021,01/14/2021,1.0,PVT,Ramipril 10mg daily aspirin 325mg daily rosuvastatin 10mg daily ezetimibe 10mg daily,NO KNOWN,Coronary artery disease,,NKDA,"['Atrial fibrillation', 'Atrial flutter', 'Palpitations', 'Supraventricular tachycardia', 'Tachycardia']",UNK,MODERNA,IM 944831,MO,27.0,F,"12/23/2020: 2 hr after injection, patient noted swollen lymph nodes, nausea, room spinning (motion sickness-like) sx. Stayed home from work that day and slept. 12/24/2020: ""typical injection site pain"" 12/30/2020: injection site hot, itchy, welts 12/31/2020: area of welts doubled in size to entire upper left arm; throat starting to close up",Not Reported,,Yes,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PUB,"bupropion, sertraline, loestrin BCP, clonapin, tizanidine, Vivanse, Adderal",none,"anxiety, depression, ADHD, insomnia",,sulfa - welts as infant,"['Cellulitis', 'Hypersensitivity', 'Impaired work ability', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site warmth', 'Lymphadenopathy', 'Nausea', 'Skin discolouration', 'Somnolence', 'Throat tightness', 'Urticaria', 'Vertigo']",1,MODERNA,IM 944853,OH,34.0,M,Lost mobility in arm. Still in physical therapy.,Not Reported,,Not Reported,Not Reported,,Yes,,11/30/2020,11/30/2020,0.0,PHM,,,,,,['Mobility decreased'],1,PROTEIN SCIENCES CORPORATION,IM 944857,FL,80.0,F,"Patient presented herself to LPN slurring words and 'not herself'. Upon evaluation, patient denied drinking alcohol, knew she was not able to speak correctly and visibly frustrated . With great difficulty she was able to communicate that she had a headache and was slightly dizzy. Failed FAST and does have a history of CVAs. EMS called and patient was taken to ER where they admitted her for observation post Stroke. Per the hosp nurse, patient received tPA treatment and will be moved to step-down unit when a bed is available.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/12/2021,01/13/2021,1.0,OTH,"Aspirin 81 MG, Famotidine 20 MG, Lasix 20MG, Levsin0.125 MG Potassium Chloride ER 10 MQ, Protonix 40 MG, Zoloft 50MG, Mutli 50+ for her, Nystatin cream, Tylenol 325MG (as needed), Zofran 4MG (as needed)",,"Anemia of Chronic illness, CVA/Stroke, Hyperlipidemia, Hypothyroidism, Unspecified Memory Loss",,NKDA,"['Cerebrovascular accident', 'Dizziness', 'Dysarthria', 'Feeling abnormal', 'Frustration tolerance decreased', 'Headache']",UNK,PFIZER\BIONTECH,IM 944998,KY,88.0,F,"On 1/11/21 noted with headache, nausea/vomiting, severe melaise. On 1/12/21 resident expired.",Yes,01/12/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/12/2021,8.0,SEN,Resident in skilled nursing facility. Please contact facility if needing all medications.,,"Asthma, hypothyroidism, essential hypertension, atherosclerotic heart disease of native coronary artery, spinal stenosis, fibromyalgia, dementia. Please contact nursing facility for further needed information.",,"Phenazopyridine, Demerol, Pyridium, Penicillins","['Death', 'Headache', 'Malaise', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 945038,WI,42.0,F,"Vaccination given 1314 and sent to waiting room for monitoring. Began to have itching at 1325. PO benadryl administered. Then with throat swelling. Epinephrine administered by EMS/Fire at 1:32pm: 0.5mg IM right arm. 1342 improving 1350 itching/throat swelling returning while EMS/Fire on phone with medical director. 1352 second dose of epinephrine administered by De Pere EMS/Fire: 0.5mg IM left arm Medical Director on site for evaluation. Client given option to transport to hospital or stay for monitoring with EMS/Dr. Condition improving, chose to stay for monitoring. Client improved and up walking halls 1513 Client cleared to be released home via private transport",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,PUB,birth control,no,no,,"Bee and cat- swelling only to bees, no anaphylaxis,","['Pharyngeal swelling', 'Pruritus']",1,MODERNA,IM 945045,LA,87.0,M,"EXTREME LETHERGY, NAUSEA, REFUSING TO EAT OR DRINK, ELEVATED HEARTRATE, FATIGUE, ELEVATED TEMP",Not Reported,,Not Reported,Yes,,Not Reported,N,01/12/2021,01/13/2021,1.0,SEN,"ALBUTEROL, ASPIRIN, BREO ELLIPTA, COLACE, ELIZQUIS, FERROUS GLUCONATE, FLOMAX, LIPITOR, METOPROLOL, PROSCAR, PROTONIX, TRAMADOL, CIPROFLOXACIN HCL","I67.89, S80.12XD, Z97.8, L97.929, S91.302D, G47.29, S60.511A, S60.512A, M62.59, U07.1, K92.1, I48.20, G93.40, I95.9, J18.9, A41.50, E87.5, R33.9, F41.9, G47.00, R06.2, Z79.811, J30.9, R25.2, D49.9, D72.829, E43, C18.7, Z86.73, D63.8, G93.41, E87.2, N31.9, R74.8, R53.81, R78.81, H61.22, I63.10, Z29.9, J44.0, R05, A46, L03.9, I48.91, S61.412A, J44.1, F33.0, R29.898, N147.9, Z79.52, A41.9, Z98.890, R53.1, L97.129, E78.5, S70.12XA, Z98.818, L29.9, N32.81, E56.9, R19.7, K21.9, L03.116, E27.40, S81.802D, I87.2, R52, D64.9,H91.90, H40.89, Z41.8, G47.23, J44.9, H16.229, E87.6, E63.9, N40.0, M62.838, L21.96,I73.9, R60.9, I10, I67.89, M62.89, L08.96, L97.922",,,LYRICA,"['Body temperature increased', 'Diet refusal', 'Fatigue', 'Heart rate increased', 'Lethargy', 'Nausea']",UNK,MODERNA,IM 945090,PA,28.0,F,"Day after vaccine : mild shortness of breath, sensation of swelling in my throat/neck area. Took Benadryl 50mg before bedtime. 2 days after vaccine: woke up with voice changes, coughing/choking with speaking. Used epipen once, felt full relief for about 1-2 hours. Trouble speaking again. Then went to ER, had epipen again twice, over two hours, Benadryl 50IV and Pepcid and steroids. Sitting in the ER now debating admission. Likely being admitted., home epipen are too expensive to treat q2h by myself.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,PVT,"Montelukast, Allegra, omeprazole",None,"Asthma, GERD",,"Lots of foods (>30), no known medication or vaccine allergies","['Choking', 'Cough', 'Dysphonia', 'Dyspnoea', 'Pharyngeal swelling', 'Speech disorder', 'Swelling']",UNK,PFIZER\BIONTECH,IM 945099,IN,48.0,F,"Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covid hub had me do a Covid test, negative result, continue high fever, no appetite, chills and body ache, Health Hub contacted me daily with app to review symptoms, Dec 27-29 continued symptoms, unable to eat and little bit of water intake, Dec 29 appointment made with Health Urgent Care, received text from Urgent Care cancelling appointment and instructed to take sips of water and Tylenol that I was having an immune reaction to vaccine. Dec 29 virtual appointment with PCP continued symptoms, Dec 31 repeat of COVID swab along with Flu swab both negative, Jan 2-3 hospital admission for abnormal labs, jaundice, dehydration, Sodium/Potassium and Magnesium boluses given, and work up for infectious process was negative. Discharged to home Jan 3 with low grade fever, dry mouth, dry eyes, nausea, body ache and continued loss of appetite. Jan 4-7 continued worsening jaundice and appetite with low grade fever, GI Clinic consulted at Health Clinic, PCP in daily contact, repeat liver function labs on Jan 8 showed worsening labs. Jan 9-12 afebrile, started Ursodiol, low appetite better energy, continue dry mouth, GI appointment Jan 12 with plan to repeat liver functions on Jan 15, jaundice improved and able to eat liquids. No Tylenol or antipyretic taken since Jan 3 due to liver function tests.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/22/2020,12/24/2020,2.0,WRK,"Pfizer Covid 19 vaccine, dose #1",none,"low dose blood pressure med, corrected hypertension multivitamin",,shellfish,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Asthenia', 'Blood alkaline phosphatase increased', 'Blood bilirubin increased', 'Blood chloride decreased', 'Blood potassium decreased', 'Blood sodium decreased', 'Chills', 'Decreased appetite', 'Dehydration', 'Dizziness', 'Dry eye', 'Dry mouth', 'Feeding disorder', 'Fluid intake reduced', 'Haemoglobin decreased', 'Influenza virus test negative', 'Jaundice', 'Liver function test abnormal', 'Lymphocyte count normal', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 945112,CA,58.0,F,"40 min. injection - 200/100 - blood pressure - and was sent to ER to get follow up and was there for 90 min, until it was 156/99. And they released me. 10 days of very high blood pressure and headaches. Just started coming down (Blood Pressure) the day before yesterday. 98/72 now. Primary Care doctor - Telemed appt- had advised me to wait it out a little and now it's down. Feel better now. DIdn't take anything to treat it. Just rested. Only worked 1/2 of day of work- and not a full 8 hr shift on my scheduled shifts. But going back now full time. Blood type RH Negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Multi-vitamin; fish oil tablet,no,no,,allergy to sulphites - MSG ; lips get fat and I have to take benadryl,"['Blood pressure increased', 'Headache', 'Impaired work ability']",1,MODERNA,IM 945133,IL,59.0,F,"Developed chest pressure 8.5 hours after vaccine, unrelieved after 3 hours, went to ED, elevated troponin, EKG changes. Admitted to hospital low grade fever next day",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/12/2021,01/12/2021,0.0,OTH,Thyroid compound T4 108 mcg T3 10 mcg ASA 162 mg sly D3 20 mcg Calcium 600 mg Amoxicillin 875 mg twice a day (one dose taken),Ear infection diagnosed 1/12/21,,,Chloraprep rash,"['Angiogram normal', 'Chest discomfort', 'Echocardiogram abnormal', 'Electrocardiogram change', 'Left ventricular dysfunction', 'Left ventricular hypertrophy', 'Pyrexia', 'Troponin increased']",1,MODERNA,IM 945238,IL,36.0,M,I developed severe abdominal pain 3 days after injection that turned out to be pancreatitis,Not Reported,,Not Reported,Yes,4.0,Not Reported,N,12/17/2020,12/25/2020,8.0,PVT,"Metformin, jardiance, victoza, lisinopril, atorvastatin, lexapro, Wellbutrin",,"Dm2, HTN, anxiety, depression",,Clindamycin,"['Abdominal pain', 'Computerised tomogram abdomen', 'Endoscopic ultrasound', 'Full blood count', 'Lipase', 'Lipids', 'Magnetic resonance cholangiopancreatography', 'Metabolic function test', 'Oesophagogastroduodenoscopy', 'Pancreatitis', 'Ultrasound scan']",1,PFIZER\BIONTECH,SYR 945241,MD,71.0,F,"71yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, VS taken at 10am, B/P 99/60, O2 sats, 95% (trach w/O2). At 11:30am, Patient showed no s/sx of distress, A&Ox3. At 11:50am, a nurse went to perform a COVID test and assessment (the facility is experiencing an outbreak), and found the patient unresponsive on the bathroom floor. CPR was immediately started; no shock advised per AED; 12:15pm EMS arrived and took over. At 12:38pm, EMT called time of death.",Yes,01/14/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,SEN,UNK,UNK,UNK,,UNK,"['Death', 'Exposure to SARS-CoV-2', 'Resuscitation', 'Unresponsive to stimuli']",UNK,PFIZER\BIONTECH, 945247,PA,96.0,F,"Has underlying dementia and often with difficulty eating. 1 week after immunization she developed a stroke with left sided weakness and difficulty swallowing. Comfort measures instituted. Not sure if this is related to the vaccine, but thought I should report",Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,SEN,"depakote, lexapro, lisinopril, multiple vitamin, senna, seroquel, tylenol",Nothing acute prior,"dementia, hypertension, depression, delusions, anxiety",,"aricept, namenda, penicillin, actonel, erythromycin, niacin","['Cerebrovascular accident', 'Chest X-ray normal', 'Death', 'Dysphagia', 'Hemiparesis', 'Urinary tract infection', 'Urine analysis abnormal']",1,PFIZER\BIONTECH,IM 945253,MD,83.0,F,"83yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, the patient reportedly got up in the middle of the night with c/o feeling ""blah"", restlessness, and nausea. VS normal, no other s/sx. At 4:15am, the patient was asked to go back to bed, assisted by a nurse and GNA. At 6am, GNA was going to do morning VS and found the patient unresponsive, no pulse, no respirations. GNA notified the nurse. At 6:03am, CPR started and EMS called. At 6:15am, EMS arrived and took over. At or around 6:30am, EMT called time of death",Yes,01/14/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,SEN,UNK,UNK,UNK,,UNK,"['Death', 'Feeling abnormal', 'Nausea', 'Pulse absent', 'Respiratory arrest', 'Restlessness', 'Resuscitation', 'Unresponsive to stimuli']",UNK,PFIZER\BIONTECH, 945289,TX,57.0,F,"I had fatigue, headache, pain, weakness and I was so miserable decided to go to ER on (12/24/20) and then was transferred to hospital admitted (12/25/20) one day - discharged on 12/26/20 at night",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,"Placamil, Celebrex, hydrocholorotidizide, Estrace, Orapamil",No,"SLE (lupus) hypertension, GERD, osteoporosis",,"codeine, sulfa","['Asthenia', 'Fatigue', 'Feeling abnormal', 'Headache', 'Laboratory test', 'Pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,SYR 945294,FL,36.0,F,"Approximately 12 hours after receiving the booster dose, she awoke feeling extremely ill and nauseous, roused me to say so, and then immediately became unresponsive and pulseless. She was admitted to hospital for cardiac work up, and all diagnostic tests have found her heart to be normal in structure and function. Cardiology believes she experienced a vasovagal syncope with asystole. She remains hospitalized at this time for initiation of sotalol therapy; she was diagnosed with frequent PVCs approximately 1 year ago.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/12/2021,1.0,WRK,none,None,"None, Hx of Wilms Tumor with kidney resection and chemotherapy at 18 mos.",,sulfa,"['Angiogram', 'Blood thyroid stimulating hormone', 'Cardiac arrest', 'Echocardiogram', 'Electrocardiogram', 'Full blood count', 'Malaise', 'Metabolic function test', 'Nausea', 'Pulse absent', 'Syncope', 'Toxicologic test', 'Troponin', 'Unresponsive to stimuli', 'Urine analysis', 'X-ray']",2,PFIZER\BIONTECH,IM 945325,MN,25.0,F,Patient felt warm. Patient's face + chest became pink and blotchy 15 minutes after administration. Patient received 2 25 mg oral capsules of Benadryl. Oxygen level 99.1. -Pulse 90. Monitored patient for 30 more minutes + she felt improved. She then discharged.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,PVT,prenatal vitamin - 1 tablet daily,None,None,,Seasonal flu shot,"['Feeling hot', 'Rash macular']",1,PFIZER\BIONTECH,IM 945326,FL,50.0,F,Fatigue/headache/body malaise one hour after 2nd dose of COVID 19 vaccine. Now c/o (L) arm pain radiating to (L) elbow/(L) leg pain/dizziness/diaphoresis weakness to (L) lower extremity.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,"Cranberry, Xigdou/ezetihab/pravastatin/flouxetin MVI / fish oil / osteo biflex / hg gluconate",DM/Hyperlipidemia/O/A/Headache/Depression/Anxiety,DM/Hyperlipidemia,,Cats/Dogs/Pollen/shrimp - causes pruritus,"['Arthralgia', 'Asthenia', 'Chest X-ray', 'Dizziness', 'Electrocardiogram', 'Fatigue', 'Full blood count', 'Headache', 'Hyperhidrosis', 'Malaise', 'Metabolic function test', 'Pain', 'Pain in extremity', 'Troponin', 'Urine analysis']",2,PFIZER\BIONTECH,IM 945327,NY,23.0,F,Pt has a rash (6x7cm oval area of erythema noted (R) deltoid no absEss or depot),Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/12/2021,7.0,PUB,,,,,,['Injection site rash'],1,MODERNA,IM 945328,MO,40.0,F,"My arm hurt after shot. Next day it still hurt. On Friday I had two red circle's on my arm. One where shot was given the other 1/2 inch below it. It was very red & had heat in it, and hurt to touch, move and swollen. 1/12 - (L) arm pain from shoulder to elbow felt ""heavy"" - (L) hand tingling 1/14 - redness continue to be present",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,SEN,"Spirintec, Flonase, Venlafaxine Spironolactone, metformin, pantoprazole One daily women's vitamin, Vision formula (Ocuvite)",None,PCOS,,"Morphine, hydrcodone","['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Limb discomfort', 'Pain', 'Paraesthesia']",1,MODERNA, 945329,TN,61.0,F,"Pt reports only soreness the day after receiving the Covid 19 vaccine, however reports on day 11 after receiving the vaccine redness to injection site with an area size of her palm, itching, and a rash at the injection site. Pt reports that her PCP gave her a steroid injection today.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/11/2021,9.0,PUB,"venlafaxine, verapimil, hctz,pravastatin,metoprolol,abilify",none,"HTN, high cholest, depression",,pcn-hives,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Pain']",1,MODERNA,IM 945330,MO,44.0,F,"Chills, Bodyaches fever 101.8, headaches, swollen aRm with redness and heat fRom 1-7-2021 - 1-8-2021 1-8-2021 to 1-13-2021 - headaches + swollen arm with Redness and heat. 1-12-2021 - Present itching at vaccine site headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,SEN,"Zyrtec 1 daily 10 mg, Zinc 50 mg 1 daily, Lisinopril 5 mg 1 daily, Cranberry 500mg 1 daily, Prozac 40 mg 1 daily, Vitamin C 500 mg 1 daily, Prilosec 40 mg 1 daily, Vitamin D3 50 mcg 1 daily, Simvastatin 80 mg @ HS - HIgh chloesteal, Multivi",None,"Depression, asthma, HTN, allergies GERD HX of Kidney stones Hypokalemia, Hypothyroidism",,Claritin Sulfa drugs,"['Blood potassium', 'Chills', 'Erythema', 'Headache', 'Injection site pruritus', 'Lipids', 'Metabolic function test', 'Pain', 'Peripheral swelling', 'Pyrexia', 'Skin warm', 'Thyroid function test']",1,MODERNA,IM 945331,AK,49.0,F,"Experciening Body Jerks, Fatigue, heahaches and chills. Sensativity at injection site in both left and right arm. Nausea < 15 minutes after injection - 1 hour later shaking & persistent jerks - Numbness both hands about 1 hour - EXTRAPARAMIDAL symptoms (EPS)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,OTH,Lorazepam 1 Mg,None,None,,"Pyridium, Macrobid; Flagyl, Sulfa, PCN, Cefzil, Guafinasine, Fire Ants, Demerol, Rocephin, Should NOT take ACE's","['Chills', 'Dyskinesia', 'Fatigue', 'Headache', 'Hypersensitivity', 'Hypoaesthesia', 'Injection site hypersensitivity', 'Nausea', 'Tremor']",UNK,MODERNA,IM 945336,WI,74.0,M,"Staff reported that he wasn't being himself. He was leaning more towards the right. Had symptoms similar to Bell's Palsy, some right sided facial droop, right eyelid drooping. On CT right maxillary sinusitis, ventriculomegaly.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/05/2021,01/05/2021,0.0,SEN,"Vitamin D, Depacote, Fiber, Finasperide, Glucosamine Sulfate, Multivitamin, Terazesin., Ibuprofen","Chest pains, COVID 11/6/2020","BPH, degenerative joint disease, GERD, Osteoporosis, Traumatic Brain Injury, Degenerative joint back",,no,"['Abnormal behaviour', 'Cerebral ventricle dilatation', 'Computerised tomogram abnormal', 'Eyelid ptosis', 'Facial paralysis', 'Laboratory test', 'Posture abnormal', 'Sinusitis']",UNK,MODERNA, 945380,NC,37.0,F,Shortness of breath Chest pain Ongoing since,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Armodafinil Zoloft,,,,,"['Chest pain', 'Computerised tomogram', 'Dyspnoea', 'Echocardiogram', 'Laboratory test']",2,PFIZER\BIONTECH,SYR 945433,CA,67.0,M,"Fever to 100.4 on day 1 after vaccine, to 101.9 on day 3 after vaccine. Acute kidney injury (creatinine rose from 1.73 to 2.43) requiring hospitalization.",Not Reported,,Not Reported,Yes,7.0,Not Reported,Y,01/05/2021,01/07/2021,2.0,SEN,"Alogliptin, glipizide, metformin, aspirin, amlodipine, atorvastatin, cholecalciferol, gabapentin, lidocaine patch, quetiapine, BiCitra, acetaminophen, bisacodyl, senna, polyethylene glycol, lubricating eyedrops, nystatin powder",History of COVID earlier in December,"Type 2 diabetes complicated by nephropathy, neuropathy and retinopathy; CKD-3; mild cognitive impairment; peripheral vascular disease; coronary artery disease; schizophrenia",,"ACE inhibitors, ARBs","['Acute kidney injury', 'Blood creatinine increased', 'Pyrexia']",1,MODERNA,IM 945504,CA,36.0,F,"After first vaccine i experienced fatigue, body aches, headache and nausea for 2 days and injection site pain for two weeks. After second Vaccine given at 9:55am. tingling of feet for about 20 mins, 30 mins after the vaccine. Two hours later fatigue, body aches, headache and nausea began. At 0030 1/12/2021 I woke up with severe chills and left chest pain, temp was 101.6 and heart rate was 160. I began to see black and chest pain was severe feeling like i was having a heart atack and was going to pass out so i called 911. I then began to get short of breath and got numbess on my legs, left arm and left side of neck. Chest pressure/pain radiated to left arm and neck. I was taken by the ambulance to hospital. Arrived around 0130. My heart rate sustained at 140s in the ER so I was admitted at 0530 am. My D Dimer was a bit elevated as well as my lactic so I was given a bolus of fluids plus maintenance. I had a CXR done, CTA chest(negative for PE), UA, Labs, entire cardiac workup including an ECHO during my admission. I also began to have loose stools and wrist joint pain. MY heart rate sustained at 125-147 for about 30 hours. Fevers on and off. After everthing was negative we determined this was secondary to the covid 19 vaccine. I was discharged 1/13/2021 at around 1:30 pm. My heart rate is still not at baseline which is 87-90. I'm 100-130 and still get very fatigued with a simple slow walking. Still having tachycardia, fevers, body aches, joint wrist pain, chest discomfort and headaches. My potassium was 3.0 at discharge so will be needing labs in a week. Also bruised a little different than I usually do with lab draws so keeping an eye on them and will be checking my platelets again in a week. Ive been taking tylenol for my fever and pain and ativan for any anxiety when my heart rate goes up. (treatment during hospital stay was normal saline bolus, nomal saline maintenance fluids at 150 cc/hr, tylenol, ativan, ice packs, rest)",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/11/2021,01/12/2021,1.0,PVT,"Vitamin D 50,000 IUs weekly, Ditropan 10mg daily, flexiril 10 mg PRN, melatonin 5mg at bedtime, multivitamins, Alani Nu Balance daily, probiotic",None,"Interstitial cystitis, Vertigo, migraines",,No allergies,"['Angiogram', 'Anxiety', 'Arthralgia', 'Blood lactic acid increased', 'Blood test', 'Cardiovascular evaluation', 'Chest X-ray normal', 'Chest discomfort', 'Chest pain', 'Chills', 'Computerised tomogram thorax normal', 'Contusion', 'Diarrhoea', 'Dizziness', 'Dyspnoea', 'Echocardiogram', 'Fatigue', 'Fibrin D dimer increased', 'Headache', 'Heart rate increased', 'Hypoaesthesia', 'Nausea', 'Neck pain', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Pyrexia', 'Scan with contrast', 'Tachycardia', 'Urine analysis normal', 'Visual impairment']",2,PFIZER\BIONTECH, 945526,CA,52.0,M,"Fever, joint pain, weakness. Pain at the injection site.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/13/2021,01/13/2021,0.0,SEN,no,covid 19 12/25/2020----12/31/2020,no,,no,"['Arthralgia', 'Asthenia', 'Injection site pain', 'Pyrexia']",UNK,MODERNA,IM 945547,OH,27.0,F,"Fatigue, nausea, vomiting, headache, swelling and redness and injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/12/2021,6.0,UNK,,,,,,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site swelling', 'Nausea', 'Vomiting']",1,MODERNA,IM 945578,KS,72.0,F,"No reactions immediately after vaccine was given. Resident has dementia, has had multiple hospitalizations related to a renal stone recently. Had a tooth that was bothering her, went to see her dentist and it was extracted on 1/6/21. On 1/10 they noted feet and ankles are dark purple with white splotches appears to be mottling. Minimally responsive to voice and touch. Not eating. Compassionate visit with family. Family did not want hospice, did not feel it was needed, said, what more could they do for her than you're already doing? On 1/11 at 1950 was determined to be deceased.",Yes,01/11/2021,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/10/2021,8.0,SEN,"Aspirin 81 mg, metformin, namenda, effexor XR, donepezil, potassium chloride, Vitamin B12, Brillinta, clonzepam, flomax, ultram, oxybutynin chloride, sucralfate, ferrous sulfate, protonix, percocent, metoprolol succinate ER, senna Colace, n",Had a tooth extraction done on 1/6/21. Was on amoxicillin for 7 days and it caused diarrhea. Changed to Keflex.,"Dementia, COPD, Type 2 DM, Atherosclerotic Heart Disease, Depression, Hypertensive Heart disease without heart failure GI hemorrhage, calculus of ureter, systolic CHF, Peripheral vascular disease, GERD, anxiety.",,NKA,"['Death', 'Decreased appetite', 'Hyporesponsive to stimuli', 'Livedo reticularis', 'Skin discolouration']",UNK,PFIZER\BIONTECH,IM 945596,CT,41.0,F,"Anaphylaxis- throat tightness , nausea , rash , pruritis , chest tightness, wheezing . 9-11 called epinephrine x 2 , decade on , IV Benadryl , duo-nebs, famotidine, admission to icu high dose prednisone , nebulizers , zofran , duo-neb nebulizers",Not Reported,,Yes,Yes,3.0,Not Reported,N,01/13/2021,01/13/2021,0.0,WRK,Albuterol HFA TRELEGY ELLIPTA nexium 40mg Lexapro 20mg,None,Asthma,,None,"['Anaphylactic reaction', 'Chest discomfort', 'Intensive care', 'Laboratory test', 'Nausea', 'Pruritus', 'Rash', 'Throat tightness', 'Wheezing']",1,MODERNA,IM 945603,KS,94.0,M,"Had no immediate issues with the vaccine. He had returned from the hospital on 12/21 and had some concerns about his weight which were shared with his physician on 1/4/21. On 1/5/21 had a visit with his cardiologist for a pacemaker check. On 1/8/21 staff were called to his room, he was on the floor, bluish skin color. No vital signs found, no heart rhythm heard at 2200.",Yes,01/08/2021,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/08/2021,6.0,OTH,"Verapamil ER, Pepcid, Norco, Vit D3, synthroid, flecainide Ace acetate, mucinex, lisinpril, amitriptyline, eliquis, atorvastatin, furosemide, acetaminophen, Coenzyme Q-10, metoprolol succinate ER",Hospitalized for abnormal heart rhythm 12/18/20.,"anemia, hypothyroidism, BPH, paroxysmal atrial fib, HTN, atherosclerotic heart disease, Chronic Kidney dz stage 3, CHF",,NKA,"['Cardiac pacemaker evaluation', 'Cyanosis', 'Metabolic function test', 'Pulse absent']",1,PFIZER\BIONTECH,IM 945642,CA,43.0,M,"COVID-19 mRNA/Pfizer-BioNTech vaccine After 1st dose- arm soreness, nausea, sleepiness and headache for 24 hours After 2nd does- fever 101.0 oral, chills, headache for hours",Yes,01/14/2021,Not Reported,Not Reported,,Not Reported,N,12/20/2020,01/14/2021,25.0,PVT,"vitamin c 1000mg, tylenol 1000mg, motrin 400 mg",,,,,"['Chills', 'Headache', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Somnolence']",2,UNKNOWN MANUFACTURER,IM 946141,IN,83.0,F,Moderna COVID-19 Vaccine At 2 PM I went blind in my left eye. Went to emergency room at Hospital Was told I have Blood clot in my eye causing the blindness and Ophthamologist says it will probably be permanent,Not Reported,,Not Reported,Not Reported,,Yes,N,01/14/2021,01/14/2021,0.0,PUB,,None,,,None,"['Blindness unilateral', 'Computerised tomogram', 'Neurological examination', 'Ophthalmological examination', 'Thrombosis', 'Ultrasound eye', 'Visual acuity reduced']",UNK,MODERNA, 947220,GA,68.0,F,"Stomach (Abdominal pain); Nausea, headache, feverish, but no temp; minor Body aches. Began around 9:00 A.M. (2 hrs After injection). Nausea & other symtoms gone by A.M. 12-29-20.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"Inderal, chloresteramine; prevacid, Allergy 4",None,None,,None known,"['Abdominal pain upper', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 947396,,66.0,F,"Dizziness Narrative: employee said her heart was low, so she laid on the floor C/o sweaty, diziness, lying on floor felt better. PMH of vascular response, taking beta blocker had juice felt better. Vss. 115/76 bp pulse 65. Recheck b/p 103/69 65 pulse, 101/68 pulse 69 oxygen sats room aire were 100. initial pulse was 43 b/p 115/76. Resolved after rest elevated legs, and fluids. Employee left about after and hour walking well, with no further c/o symptoms all seemed to resolved She was instructed to go the emergency room any further symptoms. She verbalized back the plan.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/31/2020,,OTH,,,,,,"['Dizziness', 'Heart rate decreased', 'Hyperhidrosis']",1,PFIZER\BIONTECH,IM 947646,IA,57.0,F,tingling and numbness in Right hand (5 min) sweating and anxiety felt foggy 20 min.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/14/2021,01/14/2021,0.0,SEN,,,,,,"['Feeling abnormal', 'Hyperhidrosis', 'Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 947648,MN,52.0,M,"Pt. with dizziness, then Afib with RVR, then massive cerebral hemorrhage Pt. non oriented & unable to give history - History provided by S.O and daughter",Not Reported,,Yes,Yes,,Yes,N,01/05/2021,01/05/2021,0.0,PVT,Multiple,No Acute only chronic,"T2DM, HTN, CAD, CHF, AICD, anticoag(+)",,Adhesives,"['Atrial fibrillation', 'Cerebral haemorrhage', 'Disorientation', 'Dizziness', 'Laboratory test']",UNK,MODERNA, 948053,NY,60.0,F,Upper lip feeling numb/numbness resolving @ 925 AM vs 138/77 P 66 O2 sat 100% RA,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/14/2021,01/14/2021,0.0,PVT,Vit C. and Zinc,,Migraines,,Sulphur,"['Hypoaesthesia oral', 'Lip swelling']",2,PFIZER\BIONTECH,IM 948059,MS,53.0,F,"Pt noted rash on (L) knee, progressed to both thighs, lower back and both arms. Now also on bith arms, upper back and ears, and both legs. Very itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,B Complex,,,,,"['Rash', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 948063,MI,31.0,F,"Initially - localized discomfort. Redness days after - swelling at sign of injection, fatigue, strong stomach pain on 1-6-21 further discomfort and swelling two inches distal of injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/06/2021,6.0,SEN,Valacyclovir - Rizatriptan - Ondansetron Prenatal vitamins - Tylenol - Motrin,None,Migraines,,Macrobid - Ciprofloxin,"['Abdominal pain upper', 'Fatigue', 'Injection site discomfort', 'Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 951175,RI,64.0,F,"Bilateral Axilla, dominant on vaccinated arm rash, itch Redness, Swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,,,WRK,"Afluria, cyclobenzaprine, fluticasone propionate, losartan, meloxicam, montelukast, omeprazole, Symbicort, zinc, Zyrtec,",,"Hypertension, Gerd, Prediabetes",,NKDA,"['Erythema', 'Lymphadenopathy', 'Pruritus', 'Rash', 'Swelling']",2,PFIZER\BIONTECH,IM 963167,DE,88.0,M,Narrative: Symptoms: & Cardiac Arrest; Death Treatment: EPINEPHRINE,Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/04/2021,2.0,OTH,,,,,,"['Cardiac arrest', 'Death']",2,MODERNA, 963168,,80.0,M,"shaking, altered consciousness Narrative: One day after pt received his first covid vaccine, pt experienced upper extremity shaking leading to ED visit and subsequent hospitalization with concern for seizure. Examination and labs were not consistent with seizure. He had features of lewy body disease and parkinsonism. Labs were significant for leukocytosis, but pt had no other signs/symptoms of infection or findings to indicate a source of infection. Pt referred to Neurology.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['Altered state of consciousness', 'Dementia with Lewy bodies', 'Laboratory test', 'Leukocytosis', 'Parkinsonism', 'Tremor']",1,PFIZER\BIONTECH, 967754,,67.0,F,"Death - unknown cause, no reported side effects Narrative: Unknown cause of death",Yes,01/05/2021,Not Reported,Not Reported,,Not Reported,U,12/21/2020,01/05/2021,15.0,OTH,,,,,,['Death'],1,PFIZER\BIONTECH,IM 945754,IL,,M,"suspected vaccination failure; HBV; Cytomegalovirus; Aspergillus fumigatus; cough; wheezing; shortness of breath; intermittent chills; Possible bronchitis; influenza A; fever; productive cough/progressive cough; brain abscesses; brain lesions; nausea; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 54-year-old male patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included maraviroc unknown (batch number UNK, expiry date unknown) for hiv infection, dolutegravir unknown (batch number UNK, expiry date unknown) for hiv infection, darunavir unknown (batch number UNK, expiry date unknown) for hiv infection and ritonavir unknown (batch number UNK, expiry date unknown) for hiv infection. The patient's past medical history included smoker. Concurrent medical conditions included acquired immunodeficiency syndrome (HIV-1 approximately 25 years prior, his CD4 count was 12 cells/mm3). On an unknown date, the patient received Hepatitis B vaccine, maraviroc at an unknown dose and frequency, dolutegravir at an unknown dose and frequency, darunavir at an unknown dose and frequency and ritonavir at an unknown dose and frequency. On an unknown date, unknown after receiving Hepatitis B vaccine and not applicable after starting maraviroc and dolutegravir, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), hepatitis b (serious criteria hospitalization and GSK medically significant), cytomegalovirus infection (serious criteria hospitalization and GSK medically significant), aspergillus fumigatus infection (serious criteria hospitalization and GSK medically significant), cough (serious criteria hospitalization), wheezing (serious criteria hospitalization), shortness of breath (serious criteria hospitalization), chills (serious criteria hospitalization), bronchitis (serious criteria hospitalization), influenza a virus infection (serious criteria hospitalization), fever (serious criteria hospitalization), productive cough (serious criteria hospitalization), brain abscess (serious criteria GSK medically significant), brain lesion and nausea. The patient was treated with levofloxacin, sulfamethoxazole + trimethoprim (Trimethoprim-Sulfamethoxazole), prednisone, piperacillin + tazobactam (Piperacillin-Tazobactam), vancomycin, voriconazole, micafungin and emtricitabine + tenofovir. The action taken with maraviroc was unknown. The action taken with dolutegravir was unknown. The action taken with darunavir was unknown. The action taken with ritonavir was unknown. On an unknown date, the outcome of the vaccination failure, hepatitis b, cytomegalovirus infection, aspergillus fumigatus infection, cough, wheezing, shortness of breath, chills, bronchitis, influenza a virus infection, fever, productive cough, brain abscess, brain lesion and nausea were unknown. It was unknown if the reporter considered the vaccination failure, hepatitis b, cytomegalovirus infection, aspergillus fumigatus infection, cough, wheezing, shortness of breath, chills, bronchitis, influenza a virus infection, fever, productive cough, brain abscess and brain lesion to be related to Hepatitis B vaccine. The reporter considered the nausea to be related to maraviroc and dolutegravir. Additional details were provided as follows: This was reported in a literature article and described the suspected vaccination failure, in a male patient aged 54-year-old, who was vaccinated with unspecified Hepatitis B vaccine (manufacturer unknown) for prophylaxis. The patient was a man with a history of acquired immunodeficiency syndrome (AIDS). At the time of initial diagnosis of HIV-1 approximately 25 years prior, his CD4 count was 12 cells/mm3. The patient had poor adherence to antiretroviral therapy (ART). The patient reported stopping his ART (maraviroc, dolutegravir, darunavir, and ritonavir) for approximately 4 months prior to presentation due to nausea, but he had restarted again two months prior to admission. Social history was significant for smoking. The patient worked as a nurse in a prison facility for several years. The patient was in a monogamous relationship with 1 male partner. The patient had 4 dogs and 1 pet cat. No information on patient family history was reported. On an unknown date, the patient received unspecified hepatitis B vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age at vaccination was not reported. Since 2009, the patient had positive surface antibody titers noted. On an unknown date, an unknown time after vaccination, the patient experienced cough, wheezing, shortness of breath, and intermittent chills. The patient was evaluated in the emergency department and was given trimethoprim-sulfamethoxazole for possible bronchitis. The patient symptoms did not improve, and presented again after 1 week at which time he was tested positive for influenza A. When symptoms still persisted, the patient was then started on prednisone and levofloxacin 1 week later. The patient had some relief from his symptoms but soon after his fevers recurred with productive cough and shortness of breath. The patient was therefore admitted and noted to have a fever of 102F. Piperacillin-tazobactam and vancomycin were started in addition to trimethoprim-sulfamethoxazole for broad empiric treatment. The patient left against medical advice on day 3, only to be readmitted to the hospital after cell free DNA (cfDNA) testing of plasma returned positive for Aspergillus fumigatus, HBV, and Cytomegalovirus (CMV) within 72 hours of specimen collection. On an unknown date, the patient presented with progressive cough, wheezing, shortness of breath, and intermittent chills for 1 month. Computed tomography (CT) of the chest was done which showed a left lower lobe 4 centimeter necrotic cavitary mass-like consolidation with thickened irregular walls, shaggy inner linings and septations, ground glass halo, as well as pericavitary irregular nodules and consolidations. The appearance of the cavity was consistent with angioinvasive aspergillosis. cfDNA next generation sequencing (NGS) was sent and revealed the presence of Aspergillus fumigatus, HBV, and cytomegalovirus (CMV). Aspergillus fumigatus was detected at 242 DNA molecules per microliter (MPM; reference level less than 10) and CMV level was 378 MPM. DNA sequencing detected HBV, but MPM was not reported as there is no environmental control for this virus. A sputum fungal culture eventually returned positive for heavy Aspergillus fumigatus after approximately 2 weeks, with a voriconazole MIC of 0.5 ug/mL. Levels of Serum Tests at presentation Aspergillus Galactomannan was 0.660 (ref range less than 0.5), Beta-d Glucan was more than 500 pg/mL ref range less than 80 pg/ml). Histoplasma urine antigen testing was negative. Serum CMV PCR testing showed a low-level viremia of 256 IU/ml. Repeat HBV testing demonstrated positive surface antigen, loss of surface antibody, positive core antibody, and positive E antigen. Hep B DNA was more than 1000,000,000 IU/mL, which along with elevated liver enzymes (aspartate aminotransferase (AST) of 55 U/L; alanine amino transferase (ALT) was 73 U/L) suggested active infection. The patient was admitted and during this admission, the patient was noted to have a CD4 count of 76 cells/mm3 with undetectable HIV viral load. Four months prior, the patient CD4 count was 379 cells/mm3. A magnetic resonance imaging (MRI) of the brain was done due to concern for central nervous system involvement. It showed 8, scattered, small nodular rim-enhancing lesions in bilateral cerebral and cerebellar hemisphere. Lumbar puncture was performed that showed total nucleated cell count of 2 with 88% neutrophils on differential. Cerebro-spinal fluid (CSF) glucose was 42 mg/dl, protein level was 28.9 mg/dl, and no growth of fungus was noted from CSF culture. Toxoplasma IgG and IgM were negative. Given the overall clinical picture, these brain lesions were consistent with brain abscesses due to disseminated aspergillosis from the lungs. CMV infection was assessed to be a result of reactivation in the setting of immunodeficiency, and not likely a contributing cause of lung or brain infection. A repeat chest x-ray 2 weeks after discharge showed improvement in bilateral consolidations. Repeat serum aspergillus antigen level in 1 month was undetectable. During follow up, 4 months later, Levels of Serum Tests showed Aspergillus Galactomannan was less than 0.50, Beta-d Glucan was 63 pg/mL, Hep B DNA was 541000 IU/mL and alanine amino transferase (ALT) was 49 U/L. HBV DNA PCR repeated after 4 months was 5.75 log IU/ml, and the CD4 count improved to 265 cells/mm3. CT scan of the chest was done 6 months after starting treatment and showed regression of the irregular cavitary consolidation within the superior segment of the left lung. The case was considered as suspected vaccination failure being time to onset and dosing schedule unknown. The case was considered as serious due to suspected vaccination failure and hospitalization. Treatment included: Given the result of cfDNA NGS, along with imaging and history suggestive of invasive aspergillosis of the lungs and brain, the patient's treatment was changed to voriconazole given as a loading dose of 6 mg/kg every 12 hours intravenously (IV) and then continued at 4 mg/kg every 12 hours after the initial 2 loading doses. Micafungin was added for synergy with voriconazole. He was switched to oral voriconazole 200 mg twice daily after 2 weeks of IV treatment with plans to continue treatment for at least 12 months. The patient was also started on emtricitabine-tenofovir treatment for HBV infection. Antiretroviral therapy was resumed with maraviroc, dolutegravir, darunavir, and ritonavir. The authors commented ""NGS of cfDNA has another advantage of detecting co-infections. Our patient, who reported prior immunization to HBV with documented protective titers, tested positive for this virus as an incidental finding. Subsequently, HBV DNA detected in the blood by PCR and elevated liver transaminases confirmed active infection. The patient's HBV infection could be explained by the loss of immune response from initial vaccination with subsequent exposure in the setting of lowered CD4 count off of ART. This case highlights that the HBV co-infection could have been missed if the focus was on obtaining bronchoscopy-guided tissue sampling due to high suspicion of invasive aspergillosis on presentation. There is, therefore, potential utility of using NGS of cfDNA to rapidly diagnose multiple co-infections in severely immunocompromised patients without the need for invasive diagnostic procedures. In this case, the patient benefited from early Hepatitis B treatment because of this test. Frequently, this test can detect DNA viruses, such as CMV and herpes simplex virus 1, which could be present in the blood of immunocompromised hosts without clinical manifestations indicative of active disease to warrant directed treatment. Our case reflected that as well; the patient improved with ART and did not need directed CMV treatment. It is also possible that infections in certain organ systems may result in lower levels of pathogen cfDNA, reducing the sensitivity of the test. Thus, the clinical utility of plasma cfDNA testing should be assessed for usefulness on a case-by-case basis and needs to be interpreted cautiously within the clinical context"". The authors concluded ""Plasma NGS testing of cfDNA has been helpful in diagnosing invasive fungal infections, including Rhizopus, Scedosporium, and Aspergillus.6 In order to maximize sensitivity, it is best if this test is sent early and prior to initiating antimicrobial therapy. The advantage of the test is that it is non-invasive and can potentially help with pathogen identification with results available within 72 hours. This may provide significant diagnostic value even if sent after initiation of empiric antimicrobial therapy. Another advantage is its capacity to detect co-infections, which is important in immunocompromised patients who can present with multiple opportunistic infections as well as reactivation of prior infections, as seen in our patient. Several limitations of NGS should be kept in mind. At this time, more research is needed to determine the appropriate Plasma NGS testing of cfDNA has been helpful in diagnosing invasive fungal infections, including Rhizopus, Scedosporium, and Aspergillus.6 In order to maximize sensitivity, it is best if this test is sent early and prior to initiating antimicrobial therapy. The advantage of the test is that it is non-invasive and can potentially help with pathogen identification with results available within 72 hours. This may provide significant diagnostic value even if sent after initiation of empiric antimicrobial therapy. Another advantage is its capacity to detect co-infections, which is important in immunocompromised patients who can present with multiple opportunistic infections as well as reactivation of prior infections, as seen in our patient. Several limitations of NGS should be kept in mind. At this time, more research is needed to determine the appropriate."" This article is not available for regulatory submission due to copyright restriction.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,Maraviroc; Dolutegravir; Darunavir; Ritonavir,"Acquired immunodeficiency syndrome (HIV-1 approximately 25 years prior, his CD4 count was 12 cells/mm3)",Medical History/Concurrent Conditions: Smoker,,,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Aspergillus infection', 'Aspergillus test', 'Blood HIV RNA', 'Blood HIV RNA below assay limit', 'Blood beta-D-glucan increased', 'Blood immunoglobulin G normal', 'Blood immunoglobulin M', 'Brain abscess', 'Bronchitis', 'CD4 lymphocytes', 'CSF glucose', 'CSF neutrophil count increased', 'CSF protein', 'Central nervous system lesion', 'Chest X-ray abnormal', 'Chills', 'Computerised tomogram abnormal', 'Computerised tomogram thorax', 'Computerised tomogram thorax abnormal', 'Cough', 'Cytomegalovirus infection', 'Cytomegalovirus test positive', 'Cytomegalovirus viraemia', 'Dyspnoea', 'Fungal test positive', 'Hepatitis B', 'Hepatitis B DNA assay positive', 'Hepatitis B antigen positive', 'Hepatitis B core antibody positive', 'Hepatitis B surface antibody', 'Hepatitis B surface antigen', 'Hepatitis E antigen positive', 'Influenza', 'Influenza virus test positive', 'Lumbar puncture', 'Lung consolidation', 'Lung opacity', 'Magnetic resonance imaging brain abnormal', 'Nausea', 'Productive cough', 'Pulmonary mass', 'Pyrexia', 'Sputum culture', 'Urine analysis', 'Vaccination failure', 'Viraemia', 'Wheezing']",UNK,UNKNOWN MANUFACTURER, 945755,,14.0,F,"Stiff Person Syndrome; right internuclear ophthalmoplegia; dysmetria in left more than right hands; Stiff Person Syndrome Phenotype as Progressive Encephalomyelitis with Rigidity and Myoclonus; horizontal double vision; upper back tightness and spams; upper back tightness and spams; left shoulder/arm stiffness; dysarthria; impaired saccades on right gaze; downbeat nystagmus; torso rigidity; spasticity in the hands and arms; bradykinesia; hyperreflexia; impaired fine finger movements and foot tapping; Stiff Person Syndrome Phenotype as Progressive Encephalomyelitis with Rigidity and Myoclonus; This case was reported in a literature article and described the occurrence of stiff person syndrome in a 14-year-old female patient who received HPV 16-18 (HPV vaccine) for prophylaxis. Concurrent medical conditions included autoimmune thyroiditis and type i diabetes mellitus. On an unknown date, the patient received HPV vaccine. On an unknown date, 3 months after receiving HPV vaccine, the patient experienced stiff person syndrome (serious criteria GSK medically significant), ophthalmoplegia (serious criteria GSK medically significant), dysmetria (serious criteria GSK medically significant), encephalomyelitis (serious criteria GSK medically significant), double vision, tightness of back muscles, spasms, limbs stiffness, dysarthria, saccadic eye movement, nystagmus, rigidity, spasticity, bradykinesia, hyperreflexia, movement disorder and myoclonus. The subject was treated with immunoglobulins nos (Intravenous Immunoglobulin), baclofen and benzodiazepine, nos (Benzodiazepines). On an unknown date, the outcome of the stiff person syndrome, ophthalmoplegia, dysmetria, encephalomyelitis, double vision, tightness of back muscles, spasms, limbs stiffness, dysarthria, saccadic eye movement, nystagmus, rigidity, spasticity, bradykinesia, hyperreflexia, movement disorder and myoclonus were unknown. It was unknown if the reporter considered the stiff person syndrome, ophthalmoplegia, dysmetria, encephalomyelitis, double vision, tightness of back muscles, spasms, limbs stiffness, dysarthria, saccadic eye movement, nystagmus, rigidity, spasticity, bradykinesia, hyperreflexia, movement disorder and myoclonus to be related to HPV vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of Stiff Person Syndrome in a 14.8 years old female patient, who was vaccinated with unspecified Human Papillomavirus (HPV) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of the study that aimed was to characterize the spectrum of clinical features and examination findings in pediatric-onset stiff person syndrome. [In this study, medical records were reviewed for all patients treated for stiff person syndrome with symptom onset in childhood at a tertiary medical center between March 2001 and February 2019. Cases were included if they met clinical criteria for stiff person syndrome (SPS) based on an adapted Dalakas Criteria and if SPS symptom onset occurred before age 18 years]. The patient was woman. The patient had personal history of autoimmunity as autoimmune thyroiditis, Diabetes mellitus type 1. The patient had no family History of autoimmunity. No information on patient's concurrent condition or concomitant medication was provided. On an unspecified date, 3 months before symptom onset, the patient received unspecified Human Papillomavirus (HPV) vaccine (administration route and site unspecified, dosage unknown; batch number not provided). On an unspecified date, between March 2001 and February 2019, an unknown period after the vaccination, the patient had initial presentation to center as horizontal double vision; upper back tightness and spasms; left shoulder/arm stiffness. Time to diagnosis from Symptom Onset was 6.5 years. Exam findings at initial presentation to center was dysarthria; right internuclear ophthalmoplegia; impaired saccades on right gaze; downbeat nystagmus; torso rigidity; spasticity in the hands and arms; bradykinesia; hyperreflexia; dysmetria in left more than right hands; impaired fine finger movements and foot tapping. At the age of 21.3 years, the patient was diagnosed to Stiff Person Syndrome Phenotype as Progressive Encephalomyelitis with Rigidity and Myoclonus. Serum Anti-glutamate decarboxylase 65 (GAD65) antibody titers was 89856 IU/ml (normal less than or equal to 1 IU/ml). Serum anti-amphiphysin antibodies was negative. Serum Anti-Glycine receptor (GlyR) Antibodies was not performed. CSF white blood cell count was unknown (normal 6-7/uL). CSF Protein was unknown (normal 15-60 mg/dL). More than 2 oligoclonal bands unique to CSF was unknown. CSF Anti-GAD65 antibody titers was positive (titer unknown) (normal less than 0.02 nmol/L). Electromyography (EMG) was normal. Immunotherapy received or currently receiving was intravenous immunoglobulin. Relevant symptomatic treatments received or currently receiving was Baclofen, benzodiazepines. Modified Rankin Scale (mRS) score at Most Recent Visit was 4. Timed 25 foot walk test at most recent visit was wheel-chair bound. [Within the study period, 186 patients with SPS were seen. Fifteen patients (8%) had symptom onset in childhood, of whom 11 (73%) were female and 13 (87%) were a specific ethnicity. The median age of symptom onset was 14.8 years (range 8.4 to 16.9 years), and the median latency from symptom onset to diagnosis was 6.2 years (range 0.4 to 15.0 years). Nine individuals (60%) were not diagnosed until adulthood, despite symptom onset occurring during childhood. Twelve individuals met criteria for classic SPS and three for progressive encephalomyelitis with rigidity and myoclonus (PERM). Individuals had a median total of four of the 12 symptoms and examination findings assessed (range 2 to 8), and 13 individuals (87%) had three or more reported features. Of the 15 individuals who met inclusion criteria, 11 (73%) were female and 13 (87%) were a specific ethnicity. Median age at symptom onset was 14.8 years (range 8.4 to 16.9), and median latency from symptom onset to diagnosis was 6.2 years (range 0.4 to 15.0). Nine individuals (60%) were not diagnosed until adulthood. The most common presenting features were painful spasms (n = 12, 80%), hyper-reflexia (n = 11, 73%), axial rigidity (n = 9, 60%), lower extremity rigidity or spasticity (n = 8, 53%), gait abnormalities (n = 6, 40%), and hyperlordosis (n = 6, 40%). Other noted features included anxiety (n = 5, 33%), dysautonomia (n = 3, 20%), and cranial neuropathies (n = 3, 20%; e.g., ptosis, double vision, nystagmus, and eye movement abnormalities). Personal (n = 9, 60%) and family history (n = 9, 60%) of autoimmune conditions was common. Serum antiglutamate decarboxylase 65 antibodies were found in 13 individuals (87%). Nearly all individuals received immunotherapy (n = 14, 93%), symptomatic medications (n = 15, 100%), and non-pharmacologic therapies (n = 14, 93%). However, most had persistent physical limitations, particularly impaired walking (n = 7, 47%) and inability to carry out previous activities (n = 14, 93%). Eight individuals (53%) reported having possible triggering events within one to three months of symptom onset. These events included a preceding infection (Ehrlichia along with Lyme disease-related Bell's Palsy and mononucleosis in one individual each), vaccination against human papillomavirus (in two individuals), concussion (in one individual), head trauma related to a motor vehicle accident (in one individual), and stressful life event (parents' divorce and familial financial stress in one individual each). Personal history (n = 9, 60%) and first-degree relative family history (n = 9, 60%) of autoimmune disease were commonly seen. Thirteen individuals (87%) had positive serum anti-GAD65 antibody titers (median 3183 IU/mL, range 1.2 to 184,320 IU/mL; normal less than or equal to 1 IU/mL) at the time of first evaluation in center, three of whom were on immunotherapy for concurrent autoimmune disease at that time. No individual had detected anti-amphiphysin antibodies, one individual had anti-GlyR antibodies, and one individual had both anti-GAD65 and anti-GlyR antibodies. Seven individuals (64%) underwent lumbar punctures; three individuals (43%) had pleocytosis (6 to 17/mL), one individual (14%) demonstrated oligoclonal bands unique to the cerebrospinal fluid, and all three individuals who had cerebrospinal fluid anti-GAD65 antibody testing were positive (more than 0.02 nmol/L). Cerebrospinal fluid (CSF) oligoclonal band testing was either unknown or not performed (n = 2) or not present (n = 1) in the three individuals with detected CSF anti-GAD65 antibodies. All individuals had electromyography, and five individuals (36%) had abnormal results: continuous muscle fiber activity at rest, or cocontraction of agonist and antagonist muscles, or combination of these findings. Nearly all individuals received immunotherapy (n = 14, 93%), symptomatic medications (n = 15, 100%), and a variety of non-pharmacologic therapies (n = 14, 93%), reporting most favorable responses to a combination of interventions. At the most recent clinic visit mRS score, which assigns scores to motor disability from 0 (no symptoms) to 6 (dead), was assessed (median 12.2 years from symptom onset, range 1.03 to 27.6 years). Individual scores ranged from 1 to 4 with a median score of 3. An increased number of symptoms and neurological examination abnormalities was seen in individuals with higher mRS scores. None of the individuals with more than four symptoms and signs had an mRS score of less than 3. Three individuals (20%) were wheelchair-dependent, and two (13%) required walker or unilateral cane. T25FW test results were available for nine individuals]. The outcome of the event was not reported. The author commented, ""In this study, we demonstrated a wide spectrum of both typical and less commonly seen features in individuals with pediatric onset SPS. Delay in diagnosis, whether secondary to unrecognized symptoms or limited knowledge of the disease by clinicians, appears to be common, as diagnosis is often delayed until adulthood, at which point disability accrual is frequently seen. Although SPS is a rare neurological disease, recognition and initiation of treatment is critical to addressing patients' symptoms and may enable improved outcomes and quality of life. Therefore such delays in diagnosis may be even more problematic in children with SPS, where functional impairment during a time of ongoing neurological and social development may have a profound impact on long term well-being and functionality. In our cohort, nearly two of three individuals did not receive a diagnosis of SPS until adulthood despite symptom onset in childhood, and median latency from symptom onset to diagnosis was more than six years. Although most children with SPS present with a similar clinical phenotype to adults with SPS, other clinical features were identified in our series. The most common presenting symptoms and examination findings were painful spasms, hyperreflexia, axial rigidity, and lower extremity rigidity and spasticity. Other features seen include gait abnormalities, hyperlordosis, dysautonomia, anxiety, and cranial neuropathies. The presence of such symptoms should therefore not discount consideration of SPS in children, especially because the full spectrum of associated signs and symptoms continues to expand. Personal and family history of autoimmune diseases was common; hence, it is important for clinicians to be aware of common comorbid autoimmune conditions and monitor their development over time. Diagnostic evaluation can aid in making the diagnosis of SPS in children, as most individuals in our series had positive anti-GAD65 antibody titers in the setting of a classic clinical phenotype. Individuals received a combination of immunotherapy as well as symptomatic pharmacologic and non-pharmacologic therapy. Nearly all described physical limitations and were unable to carry out previous activities. In our cohort, compared with individuals with the classic phenotype, those with PERM phenotypically have different presentations because of brainstem involvement, cortical involvement, and likely overall more body regions involved. Clinical presentation along with particular examination findings may help distinguish these phenotypes. In addition, the time to diagnosis appears shorter and the mRS score slightly greater in individuals with PERM phenotype compared with those with classic phenotype. The main limitations of this study and others dealing with rare conditions are (1) small sample size, (2) lack of prognostic biomarkers of disease severity or progression, and (3) treatment approaches that are not uniform and often involve a multimodal approach, leading to difficulty in understanding effects of individual treatments. Future collaborative studies will help to minimize these limitations and further our understanding of pathophysiology, optimal evaluation and management, and outcomes in this potentially debilitating disease."" The author concluded, ""This study describes our center's experience with pediatric onset SPS with the goal of increasing provider awareness of this debilitating but treatable disease. Collaborative studies in the future would help to further our understanding of the pathophysiology, ideal approach for the evaluation and management, and outcomes of this potentially debilitating disease."" This is 1 of the 2 valid cases reported in the same literature article. Upon SERM review Please downgrade the �As determined causality was updated ' from 'unknown � to �No' for the event Stiff person syndrome, Ophthalmoplegia, Dysmetria, Encephalomyelitis, Diplopia, Muscle tightness, Muscle spasms, Musculoskeletal stiffness, Dysarthria, Saccadic eye movement, Nystagmus, Muscle rigidity, Muscle spasticity, Bradykinesia, Hyperreflexia, Movement disorder and Myoclonus due to �alternate explanation'; Sender's Comments: US-GLAXOSMITHKLINE-US2021GSK007042:same reporter",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,Autoimmune thyroiditis; Type I diabetes mellitus,,,,"['Anti-GAD antibody positive', 'Anti-neuronal antibody', 'Bradykinesia', 'CSF oligoclonal band present', 'CSF protein', 'CSF white blood cell count', 'Diplopia', 'Dysarthria', 'Dysmetria', 'Electromyogram normal', 'Encephalomyelitis', 'Hyperreflexia', 'Immunoglobulin therapy', 'Modified Rankin score decreased', 'Movement disorder', 'Muscle rigidity', 'Muscle spasms', 'Muscle spasticity', 'Muscle tightness', 'Musculoskeletal stiffness', 'Myoclonus', 'Nystagmus', 'Ophthalmoplegia', 'Saccadic eye movement', 'Stiff person syndrome', 'Walking distance test abnormal', 'Wheelchair user']",UNK,UNKNOWN MANUFACTURER, 945757,,,F,"Hypercalcemia; multiple myeloma; flu-like symptoms; myalgia; This case was reported in a literature article and described the occurrence of hypercalcemia in a 65-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine. On an unknown date, less than a week after receiving Influenza vaccine, the patient experienced hypercalcemia (serious criteria hospitalization), multiple myeloma (serious criteria hospitalization and GSK medically significant), influenza-like symptoms (serious criteria hospitalization) and myalgia (serious criteria hospitalization). The patient was treated with rehydration fluid (nos) (Crystalloids), diuretics nos (Loop Diuretic (Nos)), calcitonin, pamidronic acid (Pamidronate), hemodialysis dialysate solution, bortezomib, lenalidomide, dexamethasone and zoledronic acid. On an unknown date, the outcome of the hypercalcemia, multiple myeloma, influenza-like symptoms and myalgia were recovered/resolved. The reporter considered the hypercalcemia, multiple myeloma, influenza-like symptoms and myalgia to be related to Influenza vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of hypercalcemia in a 65-years old female patient, who was vaccinated with unspecified inactivated influenza vaccine (manufacturer unknown) for prophylaxis. No information on patient's medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, 5 days prior to presentation, the patient received unspecified inactivated influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided but it could be 64 years or 65 years. On an unspecified date, an unknown period after the vaccination, the patient presented with subjective myalgias lasting 2 days. Vital signs were stable. Complete Blood Count (CBC) and basic metabolic panel (BMP) were unremarkable. Serum calcium was 10.8 mg/dl. The patient was discharged on supportive therapy. The patient presented a day later with persistent flu-like symptoms. Labs revealed serum calcium being above 22 mg/dl, normal renal function, total protein, albumin, ACE levels; clear UA with no albuminuria; low PTH and 1, 25-(OH)2-Vitamin D3 levels; elevated PTHrP & viscosity levels. 24-hour urine collection revealed proteinuria (550 mg). Peripheral blood smear revealed rouleaux formation. Computed tomography (CT) scans of the chest, abdomen and pelvis revealed no obvious malignancy. Quantitative immunoglobulins revealed elevated IgA (2415 mg/dl), and concurrent suppression of IgG and IgM levels. Quantitative serum light chain measurement revealed normal levels of kappa and lambda, with an elevated Kappa: Lambda ratio of 2:1. Serum Protein Electrophoresis (SPEP), Urine Protein Electrophoresis (UPEP), and serum immunofixation revealed IgA-Kappa multiple myeloma (MM). Given her severe-symptomatic hypercalcemia, the patient was treated with aggressive intravenous crystalloids, loop diuretics, calcitonin, pamidronate, and hemodialysis. The patient's calcium subsequently normalized to 10.1 mg/dl. Bone-marrow biopsy revealed intracytoplasmic kappa-restricted monoclonal plasma cells that occupied 40% of the marrow. Bone survey was negative for lytic lesions. The patient was started on bortezomib, lenalidomide, dexamethasone and monthly zoledronic acid; and the patient had not attained remission from myeloma yet. This case has been considered as serious due to hospitalization. The author commented, ""Multiple myeloma (MM) is characterized by the neoplastic proliferation of immunoglobulin-producing plasma cells. Several cytokines, including IL-1, IL-6 and TNF-beta, derived from myeloma cells are thought to accelerate osteoclastic bone resorption and cause hypercalcemia through a paracrine mechanism. Our case is unique in that the patient initially had a normal serum calcium level that had increased rapidly to over 22 mg/dl within a period of 24 hours, had no renal failure or any bone involvement; and had a normal quantitative serum light chain measurement. It is theorized that the inactivated influenza vaccine given prior to presentation unmasked an atypical presentation of MM. This may be attributed to a vaccination induced cytokine storm, especially IL-6 mediated, that may be the key in the pathophysiology of hypercalcemia related to MM."" This article corresponding to this case is not available for regulatory submission due to copyright restriction.",Not Reported,,Not Reported,Yes,,Not Reported,Y,,,,UNK,,,,,,"['Angiotensin converting enzyme', 'Biopsy bone marrow', 'Blood albumin normal', 'Blood calcium increased', 'Blood immunoglobulin G', 'Blood immunoglobulin M', 'Blood smear test', 'Computerised tomogram', 'Computerised tomogram normal', 'Electrophoresis protein', 'Full blood count', 'Haemodialysis', 'Hypercalcaemia', 'Influenza like illness', 'Laboratory test normal', 'Light chain analysis increased', 'Myalgia', 'Parathyroid hormone-related protein increased', 'Plasma cell myeloma', 'Protein total normal', 'Proteinuria', 'Renal function test normal', 'Urine analysis']",UNK,UNKNOWN MANUFACTURER, 945770,NV,22.0,F,"Fainting; Dizziness; Body ache; Joint pain; A spontaneous report was received from a 22-year-old female consumer, who received Moderna's COVID-19 vaccine and experienced dizziness, fainting, joint pain, and body aches. The patient's medical history was not provided. No relevant concomitant medications were reported. On 31 Dec 2020 at 13:30, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 31 Dec 2020, after vaccine administration, the patient experienced dizziness, fainting, joint pain, and body aches. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the events, dizziness, fainting, joint pain, and body aches, was not reported.; Reporter's Comments: This case concerns a 22 year-old, female patient, who experienced events of dizziness, fainting, joint pain, and body aches. The events occurred on the same day after the first dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Arthralgia', 'Dizziness', 'Pain', 'Syncope']",1,MODERNA,OT 945900,,,F,"Anaphylactic shock; A spontaneous report was received from a female consumer who received Moderna's COVID-19 Vaccine and experienced anaphylactic shock. The patient's medical history was not provided. No concomitant product use was reported. On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 31 Dec 2020, after vaccine administration, the patient experienced anaphylactic shock and was taken to the hospital. No treatment information was provided. On 01 Jan 2021, the patient reported feeling much better. Action taken with mRNA-1273 in response to the event was not reported. The event, anayphylactic shock, was considered resolved on 01 Jan 2021.; Reporter's Comments: This case concerns a female patient with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of anaphylactic shock. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the onset of the event on the day of vaccination, a causal relationship cannot be excluded and the event was considered possibly related to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Anaphylactic shock'],1,MODERNA,OT 945911,TX,48.0,F,"Had COVID infection 10 days after the getting the vaccine; Had COVID infection 10 days after the getting the vaccine; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscular in right arm on 24Dec2020 09:00 at a single dose for Covid-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to Covid vaccine. The patient was not diagnosed with Covid-19 prior to vaccination. Patient has no allergies to medications, food, or other products. Physician would like to know if her patient can receive second dose of vaccine. Patient received vaccine 10 days ago. On 05Jan2021, the patient had Covid infection 10 days after the getting the vaccine. No treatment was received for the event. Patient tested positive for Covid after receiving vaccine. The patient underwent lab test which included nasal swab: positive on 04Jan2021. The outcome of the event was recovering.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID 19 infection based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/05/2021,12.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 945917,,,F,"Caller received the first dose of covid 19 vaccine and tested positive for covid.; Caller received the first dose of covid 19 vaccine and tested positive for covid.; Caller received the first dose of covid 19 vaccine and tested positive for covid.; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable other health professional (patient) reported that a female (age: 22; unit: not reported) patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of COVID 19 vaccine and tested positive for COVID on an unspecified date. She was under quarantine and wanted to know when and if she should get the second dose. Due date for second dose is 11Jan2021. The patient underwent lab tests and procedures which included Covid-19: positive on an unspecified date. The outcome of event was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: The association between the event lack of effect (Covid-19 test positive) with BNT162b2 can not be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 945918,,,F,"had her 1st dose of Covid vaccine yesterday and started experiencing all expected side effects today including lost of smell and taste/ Rapid PCR Test which came back positive; had her 1st dose of Covid vaccine yesterday and started experiencing all expected side effects today including lost of smell and taste/ Rapid PCR Test which came back positive; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her 1st dose of COVID vaccine yesterday, 07Jan2021 and started experiencing all expected side effects today (08Jan2021) including loss of smell and taste. She also had a Rapid PCR test done today which came back positive. She wanted to know if this could be a false positive result from the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,UNK,,,,,,"['Ageusia', 'Anosmia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 945934,,,M,"It felt like a viral meningitis; arm soreness; feel some tension; migraine headache; body started shaking; chills/Rigors; temperature 104; I had sensitivity that I never had; headache; photophobia; Sinophobia; paresthesia/tingling sensation along my upper extremity; I felt like I was freezing; I didn't feel comfortable; vertigo; nausea; hard time to focus; This is a spontaneous report from a contactable other health professional (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. He didn't have any allergies. He was in good health, no underlying issue. He never had a surgery. In Jan2021, patient got the vaccine last night around. It started with arm soreness. Around 10:00 am he started to feel some tension, migraine headache. Around 11:00 he felt his body started shaking. He had chills, rigors and temperature 104. For 5-6 hours he had sensitivity that he never had. Patient had a headache, photophobia, sinophobia, paresthesia and tingling sensation along his upper extremity. he felt like he was freezing. He didn't feel comfortable. It resolved afterwards, he felt no weakness, no facial paralysis. It felt like a viral meningitis. He also had vertigo, nausea and hard time to focus. Outcome of events were unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event viral meningitis with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['Body temperature increased', 'Chills', 'Discomfort', 'Feeling cold', 'Headache', 'Hypersensitivity', 'Meningitis viral', 'Migraine', 'Nausea', 'Pain in extremity', 'Paraesthesia', 'Phobia', 'Photophobia', 'Tension', 'Tremor', 'Vertigo', 'Vision blurred']",UNK,PFIZER\BIONTECH, 945942,,,F,"I have latent TB and am diagnosed with herpes 1 and 2; I have latent TB and am diagnosed with herpes 1 and 2; This is a spontaneous report from a contactable other health professional. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. Patient had the first dose of the vaccine on 11Jan2021 and she/he had pre-existing conditions. A long time ago, she/he had 2 tachycardia episodes and was sensitive to epinephrine. Patient had latent TB and was diagnosed with herpes 1 and 2 in Jan2021. Outcome of events were unknown. Information about lot/batch number has been requested.; Sender's Comments: The association between the events ""latent PTB and Herpes 1 and 2"" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Tachycardia,,,['Herpes simplex'],1,PFIZER\BIONTECH, 945956,WI,57.0,F,"difficulty breathing and stridor; difficulty breathing and stridor; noises on inspiration; dizziness; headache; sore throat; Anaphylaxis developed within 2 hours of injection; This is a spontaneous report from a contactable other health professional (patient). A 57-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration in arm left on 08Jan2021 09:00 at single dose for covid-19 immunisation. Medical history included Idiopathic Angioedema, Hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported. Reported Event: Anaphylaxis developed within 2 hours of injection. 9:00 am injection; 9:05 am Developed sore throat, 9:20 am Developed dizziness and headache, 10:00 am developed noises on inspiration, 10:20 am Presented to Emergency Services, 10:40 am IV (intravenous) diphenhydramine (BENADRYL) and dexamethasone (DECADRON), 10:45 am difficulty breathing and stridor, 11:00 am intramuscular Epinephrine, 11:10 am Racemic Epi Nebulizer, 11:20 am Breathing improved, 14:00 Discharged home. The adverse events result in Emergency room/department or urgent care. The outcome of all the events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis reactions considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition included Idiopathic Angioedema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Hypothyroidism; Idiopathic angioedema,,,"['Anaphylactic reaction', 'Breath sounds abnormal', 'Dizziness', 'Dyspnoea', 'Headache', 'Oropharyngeal pain', 'Stridor']",UNK,PFIZER\BIONTECH, 945970,,,U,"Receives dose #1 of the covid vaccine and contracts covid prior to dose #2; Receives dose #1 of the covid vaccine and contracts covid prior to dose #2; This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for two patients. This is 2nd of two reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received dose #1 of the COVID vaccine and contracts COVID prior to dose #2 on an unspecified date. The patient underwent lab test which included Covid-19 test in which he/she tested positive on an unknown date. Outcome of the events was unknown. Information about batch/lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021012928 Same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 945972,AZ,38.0,F,"My heart rate, I was like in AFib; very high fever of 103; dizzy, light headed; arms sore; exhausted like an extreme fatigue; palpitations; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration on 30Dec2020 at 38-years-old at a single dose for COVID-19 immunization. Medical history included blood clotting disorder from an unknown date and unknown if ongoing. The patient experienced the following events and outcomes: my heart rate, I was like in AFib (medically significant) on 31Dec2020 with outcome of recovering, very high fever of 103 (non-serious) on 31Dec2020 with outcome of unknown, dizzy, light headed (non-serious) on 31Dec2020 with outcome of unknown, arms sore (non-serious) on 31Dec2020 with outcome of unknown, exhausted like an extreme fatigue (non-serious) on 31Dec2020 with outcome of not recovered, palpitations (non-serious) on 31Dec2020 with outcome of not recovered. The clinical course was reported as follows: The patient stated, ""the day after the shot I got a very high fever of 103. I was dizzy, lightheaded. My heart rate I was like in AFib, it was going from 60s to 50s all over the place. And this was the next day after the vaccination. That evening nothing my arms was just sore. But the next day all of these side effects just started in and even still today I just feel so exhausted like an extreme fatigue and I am still getting like palpitations."" The patient stated, ""So I went to urgent care and they check my vitals and stuff and when they wanted me to send me to the hospital. But I told them I will get a ride and I go by myself just because I didn't want, capable of an ambulance ride and I ended up just going home because I couldn't get a hold up anybody. So, I came home and took my blood thinner medication because I do have blood clotting disorder."" In regard to the outcomes of the events, the patient stated, ""I am not experiencing all of them still definitely my heart is much better. I am still getting palpitations but nothing near how it was that first day. I am experiencing extreme fatigue.""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,UNK,,,Medical History/Concurrent Conditions: Clotting disorder,,,"['Atrial fibrillation', 'Dizziness', 'Fatigue', 'Pain in extremity', 'Palpitations', 'Pyrexia']",UNK,PFIZER\BIONTECH, 946018,CA,,F,"received the vaccine on 17Dec2020 the next dose is today but during this time she was positive for covid; received the vaccine on 17Dec2020 the next dose is today but during this time she was positive for covid; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable nurse reported for herself, a female patient of an unspecified age who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received the vaccine on 17Dec2020, the next dose is today (07Jan2021) but during this time she was positive for covid since an unspecified date. She was asking if she would take the second vaccine or if she needed to be revaccinated with the first dose. She was also asking what should she do. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (positive for COVID) with BNT162b2 can not be fully excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 946046,KS,61.0,F,"received first dose of bnt162b2/ symptoms started on the 26th (26Dec2020) but did not test positive until the 29th (29Dec2020); received first dose of bnt162b2/ symptoms started on the 26th (26Dec2020) but did not test positive until the 29th (29Dec2020); This is a spontaneous report from a Pfizer-sponsored program via a contactable nurse (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number: VAC0002881; expiration date not provided), via an unspecified route of administration on 17Dec2020 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history included hypothyroidism and osteoporosis from unknown dates, both ongoing. Concomitant medications included levothyroxine for hypothyroidism and alendronate sodium (FOSAMAX) for osteoporosis. Patient reported that her symptoms started on the 26th (26Dec2020) but did not test positive until the 29th (29Dec2020). Patient further stated ""She received the first dose of Pfizer vaccine last 17Dec (17Dec2020) and 26Dec she was positive with COVID (later clarified of tested positive on 29Dec2020) because of someone else, it seems that it has been transferred, the virus has been transferred to her and then after a few days she got fully recovered, no symptoms, just fully recovered. She is just asking if she really need the second dose of vaccine if she is fully recovered right now."" It was reported that patient did not receive treatment for the event. Laboratory test included COVID-19 virus test on 29Dec2020 with positive result. Outcome of the event was recovered.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/29/2020,12.0,UNK,; FOSAMAX,Hypothyroidism; Osteoporosis,,,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 946061,,,U,"Tested positive for Covid, 10 days after receiving the vaccine; Tested positive for Covid, 10 days after receiving the vaccine; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID on an unspecified date 10 days after receiving the vaccine. The patient underwent lab tests and procedures which included Covid test: positive on an unspecified date. The outcome of the events was unknown. The information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,OTH,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 946072,FL,,M,"coughs once in a while, may be a nervous cough every 40 min; voice hoarse; tested positive for Covid-19; tested positive for Covid-19; didn't feel well at all; bad headache; dry cough; This is a spontaneous report from a contactable consumer who reported for himself, a 70-year-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he received the first dose of the Pfizer-BioNtech Covid-19 vaccine on Wednesday, 06Jan2021, and on that day he had no problem. On Thursday, 07Jan2021, he started experiencing dry cough. On Friday, 08Jan2021, he didn't feel well at all and had a bad headache. On Saturday, 09Jan2021, he felt better but he tested positive for Covid-19. Today, 11Jan2021, he stated he feels good, he coughs once in a while, may be a nervous cough every 40 min. He had not experienced fever or chills, he breathes well, he can hold his breath for 5-10 seconds, no chest pain or congestion, but his voice was hoarse. Patient wanted to know if this has been reported before, and wanted to know how long should he test himself again for Covid-19. The events were reported as non-serious. The outcome of the events was unknown. Information about lot/batch number is requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Cough', 'Dysphonia', 'Headache', 'Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 946080,CA,,F,"I was exposed to Covid-19 4 days after and tested + 9 days after dose #1; I was exposed to Covid-19 4 days after and tested + 9 days after dose #1; I was exposed to Covid-19 4 days after and tested + 9 days after dose #1; This is a spontaneous report from a contactable female nurse (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2) on 26Dec2020 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was exposed to Covid-19 4 days after on 30Dec2020 and tested + 9 days after dose #1 on 04Jan2021. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/30/2020,4.0,UNK,,,,,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 946082,,51.0,F,"positive for covid19; positive for covid19; got or felt sick; This is a spontaneous report from a contactable physician reported for self and consumer. This 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 at single dose for covid-19 immunisation. As soon as patient got vaccine she got or felt sick in Dec2020 and had the test and finds out she was positive, so she stays home two weeks and doesn't have no symptom at all and wants to know when has to take a test. The day after the patient developed symptoms thought it was the vaccine, but the symptoms continued for 2-3 days, the 3rd day the patient got herself tested. The patient was positive for covid19 at the time had the shot/ as soon as she got vaccinated she became positive. The patient hasn't had any symptoms for the past 2 weeks. The patient was scheduled to get retested. The patient was scheduled for 2nd dose of vaccine. The patient asked if there are any risks since developed covid the day after getting the vaccine. What if miss today. The patient wanted to know time after having no symptoms past two weeks, when she has to take a test. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Test positive for covid19 found as soon as following the vaccination, no adequate effect of the suspect vaccine thus could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,"['Immediate post-injection reaction', 'Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 946084,,,M,"I've got the 1st dose of vaccine and then unfortunately, in the interim, I started feeling sick and tested positive for Covid.; I've got the 1st dose of vaccine and then unfortunately, in the interim, I started feeling sick and tested positive for Covid.; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported he got the 1st dose of the vaccine and then unfortunately, in the interim, he started feeling sick and tested positive for Covid. The patient underwent Covid test and resulted positive on an unknown date. Outcome of the event was unknown. No follow-up activities are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 946085,,,U,"13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is 12th of 13 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Coronavirus test positive'],UNK,PFIZER\BIONTECH, 946086,CA,35.0,F,"Positive COVID-19 test with symptoms; Positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program, from a contactable nurse (patient). A 35-year-old female patient (weight 55.79 kg, height 160 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK5730) intramuscularly, in the left deltoid, at single dose, on 23Dec2020 at 12:30, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history and concomitant medications were none. On 25Dec2020, the patient felt extremely tired (fatigue). On 28Dec2020, the patient had headache and minor cough noticed. On 29Dec2020, the patient experienced back pain and she said that it felt like sunburn soreness more than anything else. She said that she literally slept 3 days in a row (29Dec2020, 30Dec2020, and 31Dec2020). On 31Dec2020, the patient lost her sense of smell and developed dizziness. On 01Jan2021, the patient experienced nausea and lost her sense of taste. COVID-19 virus test was found positive on 01Jan2021.The patient recovered from back pain, sunburn and sleepy on 31Dec2020, recovered from tiredness on 01Jan2021, recovered from nausea and dizziness on 06Jan2021. Clinical outcome of the events, smell loss, cough, headache, and loss of taste was recovering. Final clinical outcome of positive COVID-19 test with symptoms was unknown at time of this report. The case was assessed as serious (medically significant). She is scheduled to get 2nd dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 13Jan2021 and is wanting to know if she is supposed to get it.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/01/2021,9.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Ageusia', 'Anosmia', 'Back pain', 'Cough', 'Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'SARS-CoV-2 test positive', 'Somnolence']",UNK,PFIZER\BIONTECH,OT 946089,NJ,,U,"Received Covid vaccine and tested positive for Covid 10 days after; Received Covid vaccine and tested positive for Covid 10 days after; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received COVID vaccine and tested positive for COVID, 10 days after on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,OTH,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 946096,NJ,22.0,F,"started with left sided lower back pain; This is a spontaneous report from a contactable Nurse (patient). A 22-year-old female patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration at left arm on 16Dec2020 13:45 at single dose for covid-19 immunization. Medical history included allergies for All fish. The patient's concomitant medications were not reported. The patient had the first covid vaccine on 16Dec2020 and on 20Dec2020 started with left sided lower back pain. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (2 days), Life threatening illness (immediate risk of death from the event). The patient received the Heparin drip and xarelto at home for the event. The patient was not pregnant. The patient received the covid test post vaccination on 09Jan2021. Test type was Nasal Swab. The result was negative. The outcome of the event was recovered with sequel on unspecified date.; Sender's Comments: From the information provided it is unclear what is the nature of the reported event and what are the reasons that have put the subject at immediate risk of death. The event is considered possibly related to the suspect product based on the positive temporal association.",Not Reported,,Yes,Yes,2.0,Not Reported,N,12/16/2020,12/20/2020,4.0,PVT,,,Medical History/Concurrent Conditions: Fish allergy,,,"['Back pain', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 946098,MD,44.0,F,"throat closing up; struggled the breath; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Pfizer EL 3302), via an unspecified route of administration on 09Jan2021 07:30 am at single dose at left arm for covid-19 immunization. Medical history included diabetes, high blood pressure, allergies. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 10Jan2021 14:30, patient woke up with throat closing up and struggled the breath. Patient immediately drank a dose of diphenhydramine hydrochloride (BENADRYL). Patient did that two more time in the evening of 10Jan2021. Patient called the doctor in the morning. Events were considered serious per life-threatening. The adverse events resulted in doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event). Patient received treatment liquid diphenhydramine hydrochloride, epinephrine (EPI-PEN) for events. Outcome of events was recovered in Jan2021.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,WRK,,,Medical History/Concurrent Conditions: Allergy; Blood pressure high; Diabetes,,,"['Dyspnoea', 'Throat tightness']",1,PFIZER\BIONTECH, 946103,IL,46.0,F,"chills; body aches; fever; flu like symptoms; headache; was drenched in sweat; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the second dose of BNT162b2 (lot: EL1283), via an unspecified route of administration in left deltoid on 09Jan2021 15:30 at single dose for covid-19 immunization. Medical history included asthma from Dec2019 and ongoing, insomnia, hypertension. Concomitant medication included ongoing hydrochlorothiazide, metoprolol tartrate (LOPRESSOR HCT) for Hypertension. The patient previously took lopressor and experienced edema. The patient previously received the first dose of BNT162b2 (Lot number: EK5730), intramuscularly in right deltoid at single dose on 19Dec2020 for covid-19 immunization. The patient experienced fever, chills, flu like symptoms, headache all day long on 10Jan2021. The above events were reported as serious as medical significant. No nausea or diarrhea. She had chills and was drenched in sweat on 10Jan2021. She woke up at 10:30 am with chills, body aches on 10Jan2021. Last night at 10 pm she finally fell asleep. She woke up this morning (11Jan2021) and felt fine. The outcome of the event sweating was unknown, other events was recovered on 11Jan2021.; Sender's Comments: Based on a close temporal relationship there is a reasonable possibility of an association between the events and the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,LOPRESSOR HCT,Asthma,Medical History/Concurrent Conditions: Hypertension; Insomnia,,,"['Chills', 'Headache', 'Hyperhidrosis', 'Influenza like illness', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 946225,PA,70.0,F,"At approximately 10:30pm on 1/14/2021, resident was noted to have a rash on her face, hands, arms, and chest. VS:100.2, 113, 20,108/59, 84% room air. applied nasal cannula at 4-L, telephoned Physician orders 6mg Decadron one time order, a second set of Vitals , reads 99.3, 110, 20, 106/60, 90% on 4-L N/C. On coming shift advised. At approximately 2:00am on 1/15/2021, resident congested and coughing. BP 151/70, pulse 124, temp 98.1 forehead, resp 20 and pulse oc 79% on 3L. At approximately 2:30am PRN cough syrup and breathing tx. Resident's condition began to worsen with breathing tx. This LPN updated at 0248 doctor on resident's condition. Doctor gave permission for resident to go to hospital. At 4:19am the Er called to say resident passed away.",Yes,01/15/2021,Not Reported,Yes,,Not Reported,N,01/14/2021,01/14/2021,0.0,SEN,"CloZAPine 550 mg QD, Clozaril 150 mg QD, Ergocalciferol Capsule 1.25 MG (50000 UT) QD, MiraLax Powder 17 gram QD, Multivitamin QD, Remeron 45 MG QD, Sertraline HCl 200 mg QD, Simvastatin 20 MG QD, Synthroid Tablet 75 MCG QD, Tricor 14",,"Dx with Covid-19 on 12/11/2020, PERIPHERAL VASCULAR DISEASES, SCHIZOAFFECTIVE DISORDER, BIPOLAR DISORDER, EPILEPSY, HYPERLIPIDEMIA, SECONDARY PARKINSONISM, MAJOR DEPRESSIVE DISORDER, ANXIETY DISORDER, HYPOTHYROIDISM, HYPERTENSION, OBESITY, and UNSPECIFIED CHRONIC BRONCHITIS,",,Lithium,"['Cough', 'Death', 'Rash', 'Respiratory tract congestion']",1,PFIZER\BIONTECH,IM 946258,NC,52.0,F,THAT EVENING BETWEEN 10-11 PM HAD A GRAND MAL SEIZURE AND WAS UNRESPONSIVE. TAKEN TO ER WHERE BLOOD WORK WAS DONE AND CT SCAN. SENT HOME AROUND 6:30 AM ON JAN 1ST. (I DO NOT REMEMBER MUCH JUST WHAT MY FAMILY HAD TOLD ME) . I DO REMEMBER BEING SEVERLY SICK WITH VOMITING IN THE ER. CURRENTLY FOLLOWING UP WITH MY FAMILY MD AND HAVE MRI AND EEG TESTS SCHECULED WITHIN THE NEXT COUPLE OF WEEKS.,Not Reported,,Not Reported,Yes,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PUB,SYNTHRIOD VERAPAMIL (BLOOD PRESSURE) B12 CENTRUM MULTIVITAMIN,NONE,BLOOD PRESSURE SYNTHROID,,NONE,"['Blood test', 'Computerised tomogram', 'Generalised tonic-clonic seizure', 'Malaise', 'Unresponsive to stimuli', 'Vomiting']",1,PFIZER\BIONTECH,SYR 946293,VA,51.0,M,"51 year old M with h/o O2 dependent COPD, Severe pulmonary fibrosis became increasingly hypoxic around 1800hours 1/7/2021. He was transported to hospital for acute on chronic hypoxia respiratory failure. On 1/12/2021 he decompensated further, and after discussing with family and palliative care, He was changed to comfort care. He expired on 1/12/2021@2325 at medical center.",Yes,01/12/2021,Not Reported,Yes,6.0,Not Reported,,01/07/2021,01/07/2021,0.0,OTH,"Alvesco inh, Mepron susp, Coreg, Zetia, Tricor, Umeclidinum, Cellcept, Zyprexa, Prilosec, paxil, Miralax, prednisone, trazodone, xopenex inh",Pulmonary fibrosis on O2,"COPD,Severe pulmonary fibrosis,HTN,GERD",,none,"['Acute respiratory failure', 'Death', 'Hypoxia']",1,MODERNA,IM 946316,KY,54.0,F,After the injection I had a severe erythema redness to my right arm. I also had soreness and swelling to the right arm. I had a fever of 102F. I had severe malaise and body aches as well as headaches.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,none reported,none reported,none reported,,none reported,"['Erythema', 'Headache', 'Influenza virus test negative', 'Malaise', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 946327,PR,38.0,M,"On 1/14/2020 at 6:00 PM feels face, eyes, mouth, and nose swollen. He took one Benadryl 25 MG, then at 5:00 PM at the moment he feels well. This is notified to the Medical Director.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/14/2021,6.0,OTH,Benadryl 25mg,None,Asthma,,Iodine Seafood,"['Eye swelling', 'Swelling', 'Swelling face']",1,PFIZER\BIONTECH,IM 946338,KS,,U,"anaphylactic reaction; Product origin unknown; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided. On an unknown date, (reported as 5-10 years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(dose, strength, frequency, lot # and expiration date were not provided) for prophylaxis. The reporter stated that it could have been also pneumococcal 13v conj vaccine (crm197)(PREVNAR 13). On an unknown date, the patient experienced anaphylactic reaction. The outcome of anaphylactic reaction and product origin unknown was unknown. The causal relationship between anaphylactic reaction and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided. Upon internal review, the event of anaphylactic reaction was considered to be medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,Prophylaxis,,,,['Anaphylactic reaction'],UNK,MERCK & CO. INC., 946353,FL,35.0,M,"Maybe 1 minute after receiving the vaccine I began to have a syncopal episode, the nurse practitioner thought that since I was heavy I began to have a vasovagal reaction. From there they asked me to sit with the others waiting 15 minutes to make sure they were ok to leave. As I sat the symptoms would come and go, as if in a pattern, and then return. The longer I sat there the more the symptoms began to grow, after sitting for an hour they decided to send me to the ER. At this time I was experiencing nausea, vomiting, sweating, I was itchy, I could not stop coughing, it was difficult to breath, and I had the worse headache. When I got to the ER they gave me drugs to reverse the allergic reaction and told me they would watch me for a while. In the next 4 hours all of the symptoms started again and I had to get another round of the reaction drugs, I ended up going through this process 4 times before I was safe enough to go home the next day. The provider that saw me and admitted me did not do any blood work or labs, they simply provided me with the reaction drugs when needed and my home medications.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,12/28/2020,12/28/2020,0.0,OTH,"pindolol, protonix, hyrochlorothizide",unknown,Anemia Premature Atrial Contractions (PAC) Chest Pain Angina Irritable Bowel Syndrome (IBS) Headache Disorder GI Bleeding Colon Polyps Iron Deficiency Hypotension Syncope Iron Deficiency Anemia Paroxysmal Atrial Fibrillation Cardiac Arrest Pneumothorax- Bi Lateral Sepsis Acute Respiratory Distress Bacteremia Pneumonia Gastritis,,iron dextran,"['Condition aggravated', 'Cough', 'Dyspnoea', 'Headache', 'Hyperhidrosis', 'Hypersensitivity', 'Nausea', 'Presyncope', 'Pruritus', 'Syncope', 'Vomiting']",1,MODERNA,IM 946426,MA,71.0,M,"Increased lethargy on 1/14/21 at 9pm, Vital signs-106/66, Heart rate-112, temp 98.2; Sent to ER for eval admitted with fever.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/15/2021,01/15/2021,0.0,SEN,,,"History of COVID with respiratory failure, type 2 DM, Bipolar, Chronic kidney disease",,"Cephalosporins, Penicillins, Bee venom","['Lethargy', 'Pyrexia']",1,PFIZER\BIONTECH,IM 946456,MN,39.0,F,"The day after her flu shot had: Warm, swelling and tenderness at injection site hives on trunk and bilat arms eye swelling lip swelling scratchy throat She was treated in the ED with Zantac, Benedryl and epinephrine IV drip Hospitalized for 26 hours",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,11/20/2020,11/21/2020,1.0,SEN,Cozaar Questran Hydrodiuril,unknown,"HTN, OSA, Obesity, Alcohol dependence uncomplicated",,Morphine - rash tape - rash no food allergies,"['Epinephrine', 'Eye swelling', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Lip swelling', 'Throat irritation', 'Urticaria']",,"SEQIRUS, INC.",IM 946549,MA,59.0,F,"On 1/8 she took her 2nd dose of Pfizer vaccine around 3 PM. She went home in the evening and started sweating. She passed out. Her daughter was at home and she took her to the nearest hospital. Her BP was 60/34 and she had a temp of 100.3F on 1/8 during hospital admission. Her K was low. She received lot of fluids. She called our office on 1/10 and during the f/u she was still in the hospital. On 1/10 she has a temp of 98.4F and BP of 109/61. But she still has dizziness, nausea, anorexia and mild cough (Former smoker). COVID-19 test was done on 1/9, its negative. Dx was dehydration. Discharged from the hospital on 1/11, feels better but is tired. Will follow up with PCP on 1/16/21.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,,,"Metastatic melanoma, currently taking immunotherapy treatment. Former smoker",,NKA,"['Blood potassium decreased', 'Body temperature increased', 'Cough', 'Decreased appetite', 'Dehydration', 'Dizziness', 'Fatigue', 'Hyperhidrosis', 'Loss of consciousness', 'Nausea', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 946553,NM,26.0,F,"anaphylaxis by lethargy, nausea, vomiting, palpitations, funny feeling in chest, swollen lips",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,WRK,unknown,none,allergies,flu vaccine reaction unknown,flu vaccine allergy,"['Anaphylactic reaction', 'Chest discomfort', 'Electrocardiogram normal', 'Lethargy', 'Lip swelling', 'Nausea', 'Palpitations', 'Vomiting']",1,MODERNA,IM 946626,GA,42.0,F,"Patient received Pfizer COVID-19 vaccine without any immediate complication on 1/14/21approx 1455, was then escorted to observation area for a 30 minute observation time. Pt had previously had a known reaction to contrast media. Approximately 5 -8 minutes into observation, pt had one audible cough. Nurse asked patient if this was a new onset cough. The patient stated she would try to ""manage"" cough. Pt escorted to bay for monitoring. Pt developed shortness of breath and wheezing rapidly. Rapid response team called and local 9-11 also called. Pt received albuterol nebulizer treatment, placed on O2 at 8L. O2 sat 99%, HR 115-120. Respiratory therapy assisted and Rapid Response Team monitored pt while waiting for EMS. Physician order to give Epinephrine 0.3 mg IM in right deltoid, given as directed at approx 1515. Second epinephrine 0.3 mg IM given approx 1530-1535. HR 144, O2 sat 99%. Patient transported to local ER, pt intubated approx 1927.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/14/2021,01/14/2021,0.0,PVT,"Zoloft, Nexium, Synthroid, Multivitamin, Levothyroxine",unknown,"asthma, hypothyroidism, hyperlipidemia, diabetes",,"Latex, Decadron, Tramadol, Lortab, Hydrocodone, Sulfa","['Cough', 'Dyspnoea', 'Wheezing']",1,PFIZER\BIONTECH,IM 946663,NY,61.0,F,"Received the 2nd vaccine at 10am on 1/11/21 intramuscular in the right arm. At 3pm on the same day, I had a painful swolle lymph node on left side of neck. That same evening I developed pain, swelling, in my right armpit radiating to the right upper breast and down my right arm with a swollen lymph node under the right arm pit. The pain was about a number 7 on a scale of 1 to 10. The pain and swelling still persist today on 1/15/2021 Still painful, especially to touch. Still radiating down the arm. Lymph node still swollen The pain is about a 2 on a scale of 1 to 10",Not Reported,,Not Reported,Not Reported,,Yes,N,01/11/2021,01/11/2021,0.0,PVT,Zoloft 12.5 mg daily,None,None,,Codiene,"['Axillary pain', 'Breast pain', 'Breast swelling', 'Lymph node pain', 'Lymphadenopathy', 'Oedema peripheral', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Tenderness']",2,PFIZER\BIONTECH,IM 946706,NY,,U,"syncope; I've experienced right eye pain; right arm muscle / right leg muscle / pain; right arm / right leg / joint pain; Fatigue; Swelling at injection site; leakage to injection site.; Rhinitis; insomnia; coughing,; dizziness; This case was reported by a nurse and described the occurrence of syncope in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 14th October 2020, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 14th October 2020, less than a day after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced syncope (serious criteria GSK medically significant), eye pain, muscle pain, joint pain, fatigue, injection site swelling, injection site leaking, rhinitis, insomnia, cough and dizziness. The patient was treated with paracetamol (Acetaminophen) and ibuprofen. On an unknown date, the outcome of the syncope, eye pain, muscle pain, joint pain, fatigue, injection site swelling, injection site leaking, rhinitis, insomnia, cough and dizziness were unknown. It was unknown if the reporter considered the syncope, eye pain, muscle pain, joint pain, fatigue, injection site swelling, injection site leaking, rhinitis, insomnia, cough and dizziness to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient age group was not reported but it was captured as per qualification (nurse) of the patient. The age at vaccination was not reported. The nurse reported that, he or she experienced right eye pain, right arm muscle and joint pain, right leg muscle, joint pain, fatigue, swelling at injection site, leakage to injection site, rhinitis, insomnia, coughing, syncope and dizziness. The reporter had all these lovely things didn't have before this flu shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,10/14/2020,10/14/2020,0.0,UNK,,,,,,"['Arthralgia', 'Cough', 'Dizziness', 'Eye pain', 'Fatigue', 'Injection site extravasation', 'Injection site swelling', 'Insomnia', 'Myalgia', 'Rhinitis', 'Syncope']",UNK,GLAXOSMITHKLINE BIOLOGICALS, 946708,GA,,F,"anaphylactic reaction; This case was reported by a consumer via call center representative and described the occurrence of anaphylactic reaction in a female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than a year after receiving Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved. It was unknown if the reporter considered the anaphylactic reaction to be related to Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: The case was reported by patient's parent. The age at vaccination was not reported. The patient received Flarix vaccine in fall of 2019 and had an anaphylactic reaction. The reporter did not consent to follow-up. This case was linked with case US2020AMR229295, reported by same reporter.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,['Anaphylactic reaction'],UNK,GLAXOSMITHKLINE BIOLOGICALS, 946732,NY,51.0,F,"Rash, swollen tongue and 2 seizures. Admitted to hospital with diagnosis of seizure and allergic reaction.,",Not Reported,,Not Reported,Yes,,Not Reported,U,01/14/2021,01/14/2021,0.0,OTH,unknown,none,seizure disorder,,none,"['Condition aggravated', 'Hypersensitivity', 'Rash', 'Seizure', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 946749,FL,91.0,F,"7:00PM fatigued, burning up fever 100., ibuprofen/tylenol dose; Sunday afternoon nausea, loss control of body, anxious, feeling of fainting, unable to move-paralyzed, pressed button for medical help, ambulance arrived, pt transported to ER -- 102. temp ambulance, RN at hosp temp 98., pt was shaky, 8:30PM erratic heartbeat per admitting doctor - pt admitted. Pt PCP/Cardiologist contacted, kept on heart monitor, pt discharged Monday afternoon. 1/14/21 chest pain, nausea, 102. fever. symptoms",Not Reported,,Not Reported,Yes,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,,,IBS,,"sulfa, nitrofuran","['Anxiety', 'Cardiac monitoring', 'Chest pain', 'Dizziness', 'Fatigue', 'Heart rate irregular', 'Laboratory test normal', 'Nausea', 'Paralysis', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tremor']",1,PFIZER\BIONTECH,IM 946764,VT,36.0,F,"I had body aches, low grade fever and headaches.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PUB,"Labetalol 200mg QD, Diclegis 10mgg OD, Zoloft 50mg QD, Levothyroxine 150mg QD",None reported,"Kidney disease , polycystic liver disease, Haschimoto thyroiditis",,None reported,"['Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 946780,FL,33.0,F,"#Right parietal/temporal subarachnoid hemorrhage and right intra-axial hemorrhage CT brain (1/12/21): Right parietal intra-axial hemorrhage toward the convexity measuring 2.3 x 1.1 x 1.7 cm with decompression into the subarachnoid space, mild right predominantly temporal and parietal subarachnoid hemorrhage is seen with minimal associated hemorrhage along the tentorium. Mild diffuse right cerebral sulcal effacement with minimal leftward midline shift measuring 2.5 mm. #Dural sinus thrombosis CTA head (1/11/21): Increased density within the superior sagittal sinus, inferior sagittal sinus, and transverse sinuses on noncontrasted images with no flow seen on postcontrast sequences consistent with venous sinus thrombosis #Left sided weakness 2/2 above #Recent jaw alignment procedure",Not Reported,,Not Reported,Yes,,Not Reported,N,12/04/2020,01/12/2021,39.0,PVT,,,no significant medical history,,,"['Angiogram cerebral abnormal', 'Cerebral haemorrhage', 'Cerebral venous sinus thrombosis', 'Computerised tomogram head abnormal', 'Decompressive craniectomy', 'Hemiparesis', 'Subarachnoid haemorrhage']",,MODERNA,SYR 946819,IL,37.0,F,"Patient developed headache and nausea on 1-11-2021. She was hospitalized on 1-14-2021 at Hospital. Found to have dural sinus thrombosis of the superior sagittal and right transverse/sigmoid sinus on MRV brain. Currently admitted to ICU at Hospital, getting injectable blood thinners. Neurology and hematology have been consulted.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/05/2021,01/11/2021,6.0,SEN,-Altavera 0.15-30 -Lexapro 10 mg,none,none,,penicillin,"['Headache', 'Intensive care', 'Nausea', 'Superior sagittal sinus thrombosis', 'Transverse sinus thrombosis', 'Venogram abnormal']",1,MODERNA,SC 946837,IL,33.0,F,"Estimate due date: 07/13/2021 I had arm soreness it started that evening, but next morning I had severe morning sickness, nausea and vomiting, fatigue started 12/24 at night. The morning sickness and fatigue continued for about 2 days after the vaccine. I started to feel better in my pregnancy and then after the vaccine and it all came back. It lasted 3 days and I took the Zofran and felt fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,"Zofran (take as needed), prenatal vitamins",No,No,,No,"['Exposure during pregnancy', 'Fatigue', 'Morning sickness', 'Nausea', 'Pain in extremity', 'Vomiting']",1,MODERNA,SYR 946900,PA,43.0,F,Hospital Course: � Patient is a 43 y.o. female patient who originally presented to the hospital on 1/3/2021 due to Left lower extremity pain and swelling. Patient found to have extensive DVT of left lower extremity and started on heparin drip. Vascular was consulted and recommended thrombolysis. Patient was also seen by IR who took patient for thrombectomy and left iliac stent placement on 01/05/2021. Patient tolerated procedure well. Patient was transitioned from heparin drip to Eliquis upon discharge. Patient given vascular follow-up as well as Hematology follow-up.,Not Reported,,Not Reported,Yes,3.0,Not Reported,U,12/18/2020,01/03/2021,16.0,PVT,"Medication List As of 12/18/2020 �9:22 AM Amoxicillin-Pot Clavulanate 875-125 mg 1 tablet Oral Every 12 hours scheduled Ergocalciferol 50,000 Units Oral Weekly Patient not taking: Reported on 7/23/2020 Liraglutide -Weight Management 3",increasing sinus pressure postnasal drainage sore throat 99 temp congestion,Problem List As of 12/18/2020 �9:10 AM Class II obesity Dysmetabolic syndrome X Facial rhytids Family history of uterine cancer Lipoprotein deficiency Low serum HDL Vitamin D insufficiency Prediabetes,,nka,"['Angioplasty', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram pelvis abnormal', 'Deep vein thrombosis', 'Iliac vein occlusion', 'May-Thurner syndrome', 'Pain in extremity', 'Pelvic venous thrombosis', 'Peripheral artery stent insertion', 'Peripheral swelling', 'Scan with contrast abnormal', 'Thrombectomy', 'Thrombolysis', 'Ultrasound Doppler abnormal', 'Venogram']",1,PFIZER\BIONTECH,IM 946943,KY,42.0,F,"Hospitalization 4 days: High temperatures above 103.5, body aches, sweating, chills, shivering, dizzy, nauseous, apathetic, diarrhea, early onset septic, elevated white blood count, celluloses, high blood pressure, and tenderness in arms.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"nexium, celexa, dymista, zyrtec, vivance, symbicort, multi vitamine",none,"GERD, Alpha1Antitrypsin deficiency",,"penacillin, amoxicillian, keflex","['Apathy', 'Bacterial test', 'Body temperature increased', 'C-reactive protein increased', 'Cellulitis', 'Chills', 'Diarrhoea', 'Dizziness', 'Hyperhidrosis', 'Hypertension', 'Nausea', 'Pain', 'Pain in extremity', 'Red blood cells urine positive', 'Sepsis', 'Tenderness', 'Urinary occult blood positive', 'Urinary sediment present', 'White blood cells urine positive']",1,PROTEIN SCIENCES CORPORATION,IM 946959,NC,83.0,M,Sudden death 18 hours post vaccine .,Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/15/2021,1.0,PUB,,"Post COVID-19 complications, A-fib, CHF","Diabetes,",,None,"['Autopsy', 'Sudden death']",1,PFIZER\BIONTECH,IM 946972,MI,93.0,M,"Patient received first dose of Shingrix and annual flu vaccine on 10/8/20. Patient's home care therapist called on 10/9/20 that patient developed nausea, vomiting, sweating, and cough after receiving the vaccines. Called patient later that day for follow-up and his wife reported he was feeling better, but was not planning to get the second dose of Shingrix in the future. Did not receive further communication regarding the patient, until on 12/24/20 spoke to patient's wife who reports the patient expired on 10/10/20. He went to bed the evening of 10/9/20, she woke up at 1:30AM on 10/10/20 and heard the patient take two deep breaths and then he stopped breathing. She called the funeral home who had her call the police and the medical examiner was notified.",Yes,10/10/2020,Not Reported,Not Reported,,Not Reported,N,10/08/2020,10/09/2020,1.0,PVT,"Fluoxetine, Allopurinol, Omeprazole, Nadolol, Furosemide, Finasteride, Ramipril, Atorvastatin, Hydralazine, Metformin, Tamsulosin",None,"Benign Prostatic Hypertrophy, Overactive Bladder, Diastolic Congestive Heart Failure, Diabetes Mellitus, Essential Hypertension, Gastroesophageal Reflux Disorder, Generalized Anxiety Disorder, Gout, Hyperlipidemia, Obstructive Sleep Apnea, Osteoarthritis, Paroxysmal Atrial Fibrillation, Cervical Spine Stenosis, Lumbar Spine Stenosis",,"Mirtazapine, Myrbetriq, Penicillin","['Cough', 'Death', 'Hyperhidrosis', 'Nausea', 'Respiratory arrest', 'Vomiting']",1,GLAXOSMITHKLINE BIOLOGICALS,IM 946978,FL,49.0,M,"Onset of shortness of breath and cough on 1/3 that progressively got worse. Clinical diagnosis of pneumonia without fever was made, patient started azithromycin on 1/5 and albuterol treatments every 4-6 hrs. Initially he improved, but then worsened. chest xray on 1/6 was negative for pneumonia, PCR covid test was negative, albuterol treatment did not bring much relief. He started respiratory distress on 1/10 and was taken by car to the local ER where another covid test was negative and chest CT revealed multiple bilateral pulmonary emboli. The leg US revealed blood clots in both of his legs. He had an emergency catheter-delivered thrombolysis and was discharged home from the ICU on 1/12 on oral anticoagulants. He is gradually improving, but very weak. He tires easily and gets a drop in oxygen to 90- 93%, as well as an increase in the heart rate to 120 when walking less than half a mile. He runs out of breath with exertion.",Not Reported,,Yes,Yes,3.0,Yes,N,12/29/2020,01/03/2021,5.0,PVT,"lexothyroxine, vitamin D, montelukast, manesium citrate",Sinus infection at the beginning of December treated with augmentin,"hypothyroidism, allergic rhinitis",,NKDA,"['Anticoagulant therapy', 'Asthenia', 'Chest X-ray normal', 'Computerised tomogram thorax abnormal', 'Cough', 'Deep vein thrombosis', 'Dyspnoea', 'Dyspnoea exertional', 'Fatigue', 'Fibrin D dimer increased', 'Heart rate increased', 'Intensive care', 'Oxygen saturation decreased', 'Pneumonia', 'Pulmonary embolism', 'Respiratory distress', 'SARS-CoV-2 test negative', 'Thrombolysis', 'Ultrasound Doppler abnormal']",2,MODERNA,IM 947019,AZ,32.0,F,"Patient developed a hoarsenss of voice and tightness of throat and flushed feeling immediately following vaccination. Epi Pen was administered and 50 mg Benadryl given p.o., EMS transport to ED after administration of solumedrol 125 mg - received Pepcid and Zofran and NS IV in the ED. Discharged from ED with prednisone 40 mg daily x 4 day with Epi Pen prescription.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,PVT,None,Not currently ill,None that we are aware of,Meningococcal 8/6/2006 pruritis,"Meningococcal Vaccine - patient denied anaphylactic reaction to vaccine, she had pruritic and rash. She also is allergic to fruit, primarily melons and bananas - oral pruritic.","['Dysphonia', 'Flushing', 'Immediate post-injection reaction', 'Throat tightness']",1,MODERNA,IM 947096,TX,30.0,F,"15 weeks pregnant, due date 7/4/21. Fourth pregnancies one two year old, two miscarriage's. My left arm became super tender, I woke up with significant joint pain in my right knee. I almost couldn't walk, it was chronic pain when I tried to walk. It lasted about 24 hours and went away. I did inform my OB.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/30/2020,11.0,WRK,Prenatal,,Hypothyroidism,,Sulfa,"['Arthralgia', 'Exposure during pregnancy', 'Gait disturbance', 'Tenderness']",1,PFIZER\BIONTECH,SYR 947129,GA,101.0,F,"Resident received Moderna vaccine on 12/23/2020 around 5 pm. At approximately 3:35 am on 12/25/2020, resident had a CVA and died on 1/1/2021 at 3:00 am.",Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/25/2020,2.0,PVT,"Aspirin, Digoxin, Diltiazem CR, Namenda CR, Toprol XL, Acetaminophen, Vitamin D, Zyrtec","Anemia, cardiac murmur, atrial fibrillation, osteoporosis, dysphagia, hyperlipidemia, muscle weakness, aortic valve stenosis","Anemia, cardiac murmur, atrial fibrillation, osteoporosis, dysphagia, hyperlipidemia, muscle weakness, aortic valve stenosis",,None known,"['Cerebrovascular accident', 'Death']",1,MODERNA,IM 947153,OH,25.0,F,"I am currently 8 weeks and 1 day pregnant. Wednesday evening after 24 hours after the vaccine i developed redness and swelling at th injection site. I developed a low fever of 101.1F and had chills. By the next morning your symptoms were relieved. I did get diagnosed last Tuesday with Covid which was one week after the Moderna vaccine. A few days after I got diagnosed with Covid, the swelling returned at the injection site. As of today I have no redness or swelling anymore at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,"Citirizin (allergy medication), Probiotic, pre-natal vitamins",None reported,None reported,,"Penicillin, Cefalaxin","['Chills', 'Injection site erythema', 'Injection site swelling', 'Pyrexia']",1,MODERNA,IM 947213,IN,76.0,M,morning of 01/13/2021 awakened with early Bell's Palsy on right side,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/13/2021,9.0,PVT,"Fluoxetine,coreg,entresto,lasix,potassium,finasteride,crestor, metformin ER, ASA 81mcg,Slodosin, Humalog Insulin Tuojejo Insulin",none,"diabetes, heart disease",,none,"[""Bell's palsy""]",UNK,PFIZER\BIONTECH,IM 947389,ME,20.0,F,"rash ""all over""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,None,None,None,,Seasonal allergies,['Rash'],2,PFIZER\BIONTECH,IM 947472,NH,74.0,F,"it hard to inject; some came out and squirted down her arm; some came out and squirted down her arm; he did not get the full 0.3mL dose; This is a spontaneous report from a contactable nurse (patient). A 74-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via Intramuscular on 05Jan2021 13:00 at single dose in the left arm for COVID-19 immunisation. Medical history included COPD and high cholesterol. Concomitant medications included Symbicort for COPD. Patient took COVID vaccine (Verbatim) since precaution as frontline healthcare worker. On Tuesday, she received the first dose of the Pfizer COVID Vaccine. The nurse who was injecting found it hard to inject, and at the end of the injection, it came back and squirted down her arm. It was a decent amount. She is unable to say if she got 0.1ml, 0.2ml, but she certainly did not get full 0.3ml. The hospital said they are just going to go ahead and give her the second dose, but she wanted to call and find out what would be the safest thing. Would it be best to receive another dose or go ahead with the second dose or get a third dose. She is due in 2 1/2 weeks to get second dose. She also has COPD and is a little more concerned than if she were 25 years old. There was no prescriber provided. When asked about other medications, she stated she has a list of medications, but did not think they were relevant. She was diagnosed with COPD last year and had a series of test. Reporter seriousness for ""it came back and squirted down her arm"" is medically significant. Outcome of events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. There is limited information provided in this report. This case will be reassessed once additional information is available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,PVT,SYMBICORT,,Medical History/Concurrent Conditions: COPD; High cholesterol,,,"['Blood cholesterol increased', 'Exposure via skin contact', 'Needle issue', 'Underdose']",1,PFIZER\BIONTECH,OT 947477,,,F,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose on 23Dec2020 and was subsequently exposed at work to the virus and became symptomatic and tested positive on 31Dec2020. Her next scheduled dose is on Sunday, they may have to reschedule. The patient queried on how long should they delay the next dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31Dec2020. The outcome of the events was unknown. Information about Lot/Batch number is requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of suspected Covid-19 infection and suspected LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/31/2020,8.0,UNK,,,,,,"['Adverse event', 'Occupational exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 947480,NC,22.0,F,"fainting spell; almost passed out; dizzy spells; weak; This is a spontaneous report from a contactable consumer (patient herself). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), via an unspecified route of administration on 07Jan2021 in right upper arm shoulder area at single dose for prevent covid. Medical history included ongoing acne. Concomitant medication included doxycycline from 2020 (taking it 6 months ago) and ongoing for acne. Patient stated that she got the Covid vaccine yesterday 07Jan2021 and almost passed out in her kitchen after a couple hours. Patient stated got in shower had dizzy spells and was weak 07Jan2021, she felt better now. Patient stated that she was a small girl of 105 pounds and the dose could have made her sick. She wanted to make sure she did not need to go and be seen. Patent had another spell in shower this morning and stated that the fainting spell and feeling weak started at 9:00 yesterday evening on 07Jan2021. Outcome of dizzy spells was recovering, and outcome of other events were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,UNK,,Acne,,,,"['Asthenia', 'Dizziness']",1,PFIZER\BIONTECH, 947481,CA,66.0,F,"Body chills; fever that went up to 100.4 degrees F.; fatigue; excess mucus; bone pain 10/10; muscle pain 8/10; other vaccine same date vaccine date 05Jan2021; This is a spontaneous report from a contactable other health professional (patient). A 66-year-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. Medical history included DM type 2, hypertension (HTN), fibromyalgia, chronic asthma, Covid prior vaccination, No Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered at Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other vaccine same date included other vaccine same date product was Pfizer, other vaccine same date vaccine date 05Jan2021. On 06Jan2021, the patient experienced Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus. No treatment received for the adverse events Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus. The events were non-serious per the reporter. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus was recovering. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bone and muscle pain cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,OTH,,,Medical History/Concurrent Conditions: Asthma; COVID-19; Fibromyalgia; Hypertension; Type 2 diabetes mellitus,,,"['Bone pain', 'Chills', 'Fatigue', 'Mucosal disorder', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 947488,NJ,64.0,F,"burning of the tongue; Difficulty in breathing; headaches; Pressure in the chest area; nausea; dizziness; fast heartbeat; tiredness; Had a hard time swallowing at night from the dryness; bitter taste; her mouth went completely dry; patient received 0.45 mL, single dose (225mcg) of PFIZER-BIONTECH COVID-19 VACCINE; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 23Dec2020 15:00 at 0.45 mL, single dose (225mcg) at left arm to prevent COVID. Medical history included a bout of dry mouth about 7 years ago, no other relevant medical history (including any illness at time of vaccination). The patient's concomitant medications were not reported. There's no adverse events following prior vaccinations. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. From the time she got the vaccine her mouth went completely dry on 23Dec2020 and she kept thinking it would go away and she still had it. Event was reported as serious per medically significant. Had a hard time swallowing at night from the dryness. Patient had the bitter taste was also on 23Dec2020, but it went away. It lasted about 5-6 hours. Then after that the dry mouth started right after. It is tolerable but she still had it. Mentioned she had a bout of dry mouth about 7 years ago and it did go away, but she never got a diagnosis for it. Patient thought that something underlying may have triggered it again. Patient also experienced burning of the tongue, tiredness, headaches, pressure in the chest area similar to difficulty in breathing, nausea, dizziness, and a fast heartbeat on unspecified date. Outcome of event dry mouth was not recovered, outcome of event bitter taste was recovered on unspecified date in Dec2020, outcome of other events was unknown. No family medical history relevant to adverse events. No relevant tests. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Relatedness of Pfizer BioNTech Covid-19 vaccine with dry mouth and bitter taste per primary source reporter with method of assessment of global Introspection was related. Reporter seriousness for event bitter taste was not serious.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of dry mouth cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Dry mouth (about 7 years ago),,,"['Chest discomfort', 'Condition aggravated', 'Dizziness', 'Dry mouth', 'Dysgeusia', 'Dysphagia', 'Dyspnoea', 'Fatigue', 'Headache', 'Heart rate increased', 'Nausea', 'Tongue discomfort']",1,PFIZER\BIONTECH, 947493,,18.0,F,"throat tightness; This is a spontaneous report from a non-contactable other healthcare professional (HCP). An 18-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration on Jan2021 at a single dose in the left deltoid muscle for COVID 19 vaccination. Medical history and concomitant medications were not reported. The patient denied any history of previous adverse reactions to vaccines and denied reaction to her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID 19 vaccination on an unspecified date. The patient was seen at a COVID vaccine clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15-minute waiting period after the injection, the patient began to experience throat tightness on Jan2021. Treatment included: Benadryl 25mg po (orally) and Solumedrol 125mg IM. The event did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch has been obtained. No further information is expected.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of throat tightness cannot be excluded, considering the plausible temporal relationship. Sever allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,OTH,,,,,,['Throat tightness'],2,PFIZER\BIONTECH, 947499,CA,,F,"blood pressure skyrocketed, it was 175/110/Very high blood pressure; almost falling down; Severe fatigue; Dizzy/dizziness; Bad headache/severe headache; Neck pain; This is a spontaneous report from a contactable nurse (reporting for herself). An adult female patient (over the age for 60) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in an unspecified deltoid on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced dizzy/dizziness, bad headache/severe headache, neck pain on 28Dec2020 and almost falling down, blood pressure skyrocketed (175/110)/very high blood pressure and severe fatigue on 29Dec2020 10:00. Clinical details were reported as follows: After the vaccine the patient was there waiting for 20 minutes and when she got in her car, after about an hour after the patient was really dizzy and was driving and was going to get in the next lane and thank God did not get in an accident. The patient parked and called her family to come pick her up. She had a bad headache, neck pain and dizziness that lasted for an hour. Finally, they came in and took me home. The patient slept for 7 hours. 9 hours after, the headache, neck pain, and dizziness were gone. The next day at 10:00 at work the patient almost fell down and one of the coworkers held her. The patients blood pressure skyrocketed, it was 175/110 and the patient was very dizzy again had severe fatigue. Her blood pressure was high for about 2 hours and slowly came down, but the fatigue lasted for almost a week and it slowly got better. The patient underwent lab tests and procedures which included blood pressure measurement: 175/110 on 29Dec2020 skyrocketed/very high. The outcome of the events was recovered on an unspecified date. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event blood pressure increased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['Balance disorder', 'Blood pressure increased', 'Dizziness', 'Fatigue', 'Headache', 'Impaired driving ability', 'Neck pain']",1,PFIZER\BIONTECH, 947500,,,F,"exposed to my sister/she did not know she had Covid/I tested positive with Covid test; exposed to my sister/she did not know she had Covid/I tested positive with Covid test; This is a spontaneous report from a contactable other HCP (patient). This female patient of unspecified age reported for herself that she received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date were not reported) on 21Dec2020 00:00 (at unspecified age) as single dose, unspecified route, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The Patient received the vaccine on 21Dec2020 and was exposed to her sister on 22Dec2020 she did not know she had Covid. Patient tested positive with Covid test on 26Dec2020. Patient is scheduled to get second dose 11Jan2021. Lab data included a positive Covid test on 26Dec2020. The outcome of exposed to my sister/she did not know she had Covid/I tested positive with Covid test was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. Efficacy of suspect drug however, is documented 7 days after second dose. Patient has received only the 1st dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/26/2020,5.0,UNK,,,,,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 947501,TN,50.0,F,"old scar that I forgot that I have there, it just swelled up really bad; The injection site looked like ""a small pox vaccine,"" in which appear red and scabby with a blue dot in the middle; The injection site looked like ""a small pox vaccine,"" in which appear red and scabby with a blue dot in the middle; The injection site looked like ""a small pox vaccine,"" in which appear red and scabby with a blue dot in the middle; The injection site looked like ""a small pox vaccine,"" in which appear red and scabby with a blue dot in the middle; Injection site began to itch; Injection site soreness; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142 (also reported as EL0140, pending clarification), expiry date: 03Mar2021 (also reported as 31Mar2021, pending clarification), intramuscular on the right arm on 08Jan2021 06:30 at a single dose for covid-19 immunisation. Medical history included heartburn, hot flashes, Grave's disease (father also has Grave's disease), had a thyroidectomy in Dec2015, menopause, weight loss, and appetite control, allergies, compromised immune status (brother and father side with autoimmune), respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, and diabetes type 2 diagnosed in 2019 (both parents and brother also with diabetes). Concomitant medications included levothyroxine sodium (SYNTHROID) in Dec2015 for Grave's disease and had a thyroidectomy, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) on 02Jan2021 for heartburn, phentermine for weight loss and appetite control, estradiol on 02Jan2021 for hot flashes and menopause, medroxyprogesterone acetate (PROVERA) on 02Jan2021 for hot flashes and menopause, prednisone for unexplained whelps (pending clarification), and cimicifuga racemosa (also reported as black cohosh) for hot flashes. The patient previously took metformin and experienced GI upset (she quit taking metformin/it was causing GI upset because they increased dose/current dose is 1,000mg twice daily increased from 500 mg twice daily) and generic levothyroxine sodium and experienced feels like crap. The patient had no previous history of immunization with the Pfizer vaccine. No additional vaccines administered on same date of the bnt162b2. No prior vaccinations within four weeks. The patient wanted to know if she can receive the second dose of the Covid vaccine after experiencing adverse events. On 08Jan2021, the patient experienced some injection site soreness, in which she took TYLENOL for. Around 14:30, she noticed that the injection site began to itch. Around 16:00, the injection site looked like ""a small pox vaccine,"" in which appear red and scabby with a blue dot in the middle. The patient also reported, ""scar that I have on my arm, it is not a reaction, it is an old scar that I forgot that I have there, it just swelled up really bad."" Event injection site looked like a smallpox vaccine was assessed as serious-other medically important condition. No emergency room or physician's office required. Therapeutic measure was taken as a result of injection site soreness. Outcome of the event injection site looked like a smallpox vaccine was not recovered. Outcome of the events injection site soreness, injection site began to itch, vaccination site erythema, vaccination site scab, vaccination site discoloration, and old scar that I forgot that I have there, it just swelled up really bad was unknown.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event vaccination site discomfort cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,SYNTHROID; NEXIUM [ESOMEPRAZOLE SODIUM]; ; ; PROVERA; ;,,Medical History/Concurrent Conditions: Allergy; Appetite suppression; Chromosome abnormality; Endocrine disorder; Graves' disease (Father has Graves disease.); Heartburn; Hot flashes; Immunocompromised (brother and father side with autoimmune); Menopause; Obesity; Respiratory disorder; Thyroidectomy; Type II diabetes mellitus (both parents and brother also with diabetes); Weight loss,,,"['Injection site discolouration', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site scab', 'Swelling']",1,PFIZER\BIONTECH,OT 947506,PA,44.0,F,"Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the chills and everything; lethargic feeling; weak; Nausea; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling/left leg went numb; whole left side of face swelled up; left eye turned red; pressure in head; felt like someone squeezing her eyeball out; eye went black/left eye looked bruised/blackness around the eyes; whole face went numb/left side of face slightly numb; bells palsy; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 05Jan2021 at single dose for COVID-19 immunization. Medical history included cutaneous t-cell lymphoma from 2017 and ongoing, ongoing cholesterol, ongoing thyroid, covid-19 from Nov2020 to an unknown date not ongoing (lasted about 1-1.5 months; she did not have any breathing problems) and blood cancer. Concomitant medication included bexarotene ongoing for cutaneous T-cell lymphoma, rosuvastatin ongoing for cholesterol, levothyroxine ongoing for thyriod. The patient underwent lab tests and procedures which included COVID 19: positive in Nov2020, found out tested positive around holiday. Clinical course: onset about 26 hours after administered the first dose; onset as soon as she got back to work next day: 06Jan2021. The side effects were at their worst for at least 24-48 hours. Further described as all side effects occurred only on left side of her body: whole left side of face swelled up on 06Jan2021; left eye turned red on 06Jan2021; whole face went numb/left side of face slightly numb on 05Jan2021; eye went black/left eye looked bruised on 05Jan2021; pressure in head on 06Jan2021; felt like someone squeezing her eyeball out on 06Jan2021, within the first 24-48 hours, her 'left leg went numb'. She called to talk to physician and nurse who advised her to take Benadryl; which she did take and the Benadryl stopped the side effects; but she could not take a lot of Benadryl or anything because she was at work. She stayed at work because at least there were healthcare professionals, adults in case she passed out; at home she has 7 young children and is also raising her grandchild. The side effects did not completely go away. The arm thing was normal; The next day she was at work and had the swelling on left side of face; blackness around the eyes; arriving home she had headaches on 07Jan2021 and then her leg went numb for like 20 mins; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling that she started panicking because she was driving on 06Jan2021. She calmed herself down thinking it's only the left side; you can drive with your right side to get home and be fine. It was more like left side of her body was asleep, tingling, she has never had that happen before. Everything else like the headache, flu feeling was about 48 hours later (on 07Jan2021). She had COVID already back in Nov2020 for about 1-1.5 months; the next side effects she had were like the COVID symptoms she had, like the chills and everything on 06Jan2021. She had the lethargic feeling again, her head was hurting, she felt extremely weak on 06Jan2021. Patient also felt nausea on 06Jan2021, Dizzy on 08Jan2021. Another doctor said it sounded like the side effects she experienced with the vaccine sounded like allergic reaction or Bell's palsy. Patient was asking the doctor if she could get like an Epi-pen or prescription Benadryl or something because she is afraid to get the second dose of Pfizer COVID-19 Vaccine and not have something to respond to side effects with. The outcome of event whole face went numb/left side of face slightly numb was recovered on 07Jan2021, for headaches was recovering, chills and nausea was recovered on 08Jan2021. Outcome of other events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/01/2021,,PVT,; ;,Cholesterol; Cutaneous T-cell lymphoma; Thyroid disorder,Medical History/Concurrent Conditions: Blood disorder; COVID-19 (Lasted about 1-1.5 months; she did not have any breathing problems),,,"['Asthenia', 'Chills', 'Dizziness', 'Eye contusion', 'Facial paralysis', 'Feeling abnormal', 'Head discomfort', 'Headache', 'Hypersensitivity', 'Hypoaesthesia', 'Influenza', 'Lethargy', 'Nausea', 'Ocular discomfort', 'Ocular hyperaemia', 'Panic reaction', 'Paraesthesia', 'Swelling face']",1,PFIZER\BIONTECH, 947507,,,F,"felt like she had Covid; felt like she had Covid; stomach cramps; chills; aches; not feeling good; temp was around 101- 101.6/fever 102; Icy hot sensation; lethargy; arm was red and swollen; arm was red and swollen; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included covid-19 from Jul2020. The patient's concomitant medications were not reported. The patient got her injection on Tuesday (specified date unknown) at 3pm. Felt good but then woke up with stomach cramps. She went to work and at around 1pm she started having chills, aches and not feeling good at 4:30 pm her temp was around 101- 101.6 so she took Tylenol went to bed. She woke up with fever 102 and felt like she had Covid all over again reporting that she had covid in Jul. Having what she has heard described as ""Icy hot sensation"" and lethargy and not feeling good with chills aches. Then on Thursday her arm was red and swollen with the redness expanding swelling and her fever was going back up. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, the local reactions and flu like symptoms following vaccination with BNT162B2 are more likely attributed to the vaccine use. Further information like diagnostic detection of virus genetic material or virus protein antigen needed for meaningful medical assessment on protective effects with the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: COVID-19 (she had covid in Jul),,,"['Abdominal pain upper', 'Chills', 'Erythema', 'Lethargy', 'Pain', 'Peripheral swelling', 'Pyrexia', 'Sensory disturbance']",UNK,PFIZER\BIONTECH, 947511,NY,54.0,F,"convulsive chills, fever- (high); convulsive chills; fever- (high); all of my muscles and joints were flaring in extreme pain; all of my muscles and joints were flaring in extreme pain; I could NOT move my vaccine arm more than 3 inches and my whole body hurt; my vision was extremely blurry; When I tried to walk, it was slow; achy/whole body hurt; tired, and took a nap; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient (no pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) via an unspecified route of administration on the left arm on 05Jan2021 11:00 AM at single dose for COVID-19 immunisation. Medical history included having Covid the 3rd week in Mar2020, Positive for Antibodies in early May2020. Fairly sick but not emergency situation ""Long haulers"" covid symptoms that continued through Nov2020. Patient still had skin pain. Other medical history included hashimoto's. Past drug event included known allergy to codeine. The patient's concomitant medications included 25 mg of Levothyroxine in two weeks. No other vaccine in four weeks. On 05Jan2021 at 12:30, patient felt achy, tired, and took a nap. By 2:00ish. The patient's vision was extremely blurry and continued for 2 days. At 05Jan2021 8 pm- 6 hours later of convulsive chills, fever- (high) and all of her muscles and joints were flaring in extreme pain. Patient could not move vaccine arm more than 3 inches and whole body hurt as if she had been hit by a train. When patient tried to walk, it was slow. Patient groped walls for support. Patient had a televisit with a doctor friend who said this was not a normal side effect and go to emergency room (ER). Doctor or other healthcare professional office/clinic visit. Covid test post vaccination included nasal swab, Covid -19 diagnostic on 08Jan2021 with pending result. No treatment received for events. The outcome of convulsive chills fever was unknown. The outcome of other events was recovered in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,"Medical History/Concurrent Conditions: COVID-19 (Covid the 3rd week in March ""Long haulers"" covid symptoms that continued through Nov2020); COVID-19 antibody test positive; Hashimoto's disease; Sickness; Skin pain",,,"['Arthralgia', 'Bradykinesia', 'Chills', 'Fatigue', 'Gait disturbance', 'Injected limb mobility decreased', 'Myalgia', 'Pain', 'Pyrexia', 'SARS-CoV-2 test', 'Vision blurred']",1,PFIZER\BIONTECH, 947518,OR,34.0,F,"tunnel vision; experienced a sudden onset of vertigo; presyncope; My hands became cold and numb; My hands became cold and numb; fatigue; sore arm, leg/thigh aching; sniffles; sore throat; brief dry cough; slight headache; neck ache; This is a spontaneous report from a contactable Nurse (patient). A 34-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 05Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included Mild ADHD/ADD. The patient's concomitant medications were not reported. Approximately 5 minutes after receiving vaccination, she was standing in the observation room (where they had all of them stay for at least 15 minutes to ensure no severe reactions) and experienced a sudden onset of vertigo, tunnel vision and pre-syncope. Her hands became cold and numb and she was trying to talk to another staff member who was arranging/scheduling her second vaccination dose at the same time when this event occurred, but it subsided quickly and she started to feel normal again. All these events occurred at 12:45 on 05Jan2021. She reported this event right away and they had her stay in the room longer. She was stable at that point but experienced these symptoms again but very mildly twice more while she walked back to her car to go home. Other side effects on 05Jan2021 that started in the evening and for the following 2-3 days included fatigue, sore arm, leg/thigh aching, sniffles/sore throat, brief dry cough and slight headache/neck ache. Very mild and tolerable symptoms. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. The outcome of all events was resolved in Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Attention deficit hyperactivity disorder (Mild ADHD/ADD),,,"['Cough', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Neck pain', 'Oropharyngeal pain', 'Pain in extremity', 'Peripheral coldness', 'Presyncope', 'Rhinorrhoea', 'Tunnel vision', 'Vertigo']",1,PFIZER\BIONTECH,OT 947528,MA,,F,"Experienced vasovagal syncope after standing, resulting in fall; Experienced vasovagal syncope after standing, resulting in fall; Awoke with severe chills; nausea; body/muscle aches; body/muscle aches; left arm pain; extreme thirst; fatigue; This is a spontaneous report from a contactable consumer. A 44-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via an unspecified route of administration on 08Jan2021 14:30 in left arm at single dose for covid-19 immunization. There was no medical history and concomitant medications. Allergies to medications, food, or other products was no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered was in hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Jan2021 01:30 am, patient woke with severe chills, nausea, body/muscle aches, left arm pain, nausea, extreme thirst. Patient experienced vasovagal syncope after standing, resulting in fall. Worst symptoms were lasted about 30 minutes, muscle aches and fatigue continue about 16 hours later. All events were reported as non-serious. No treatment was received for these events. Outcome of all events were recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Fall', 'Fatigue', 'Myalgia', 'Nausea', 'Pain', 'Pain in extremity', 'Syncope', 'Thirst']",1,PFIZER\BIONTECH, 947532,AL,36.0,M,"foggy minded; on first vaccine it made him feel a little sluggish; tired; This is a spontaneous report from a contactable pharmacist. A 36-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular from 18Dec2020 to 18Dec2020 at SINGLE DOSE for COVID-19 immunisation. Medical history included ADHD. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and escitalopram oxalate (LEXAPRO). On an unspecified date, the patient stated that on first vaccine, it made him feel a little sluggish, tired and foggy minded. Outcome of the events was unknown.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for event mental dullness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,,,PVT,ADDERALL; LEXAPRO,,Medical History/Concurrent Conditions: ADHD,,,"['Fatigue', 'Feeling abnormal', 'Sluggishness']",1,PFIZER\BIONTECH,OT 947549,CA,40.0,F,"partial complex seizure; I lost muscle tone and collapsed; severe LUE weakness; severe pain; aura; I lost muscle tone and collapsed; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 40-year-old female not pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 30Dec2020 h 05:00 PM at single dose for COVID-19 immunisation, lot number: EH9899. Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included epilepsy (well controlled with medications) and she was allergic to phenytoin (DILANTIN). Concomitant medications in two weeks prior to the vaccination included carbamazepine, lamotrigine (LAMICTAL) and fluoxetine. It was reported that on 31Dec2020 h 14:00 (also reported as approximately 22 hours after vaccine) patient experienced severe left upper extremity (LUE) weakness and severe pain. She then experienced an aura and had a partial complex seizure. Patient lost muscle tone and collapsed. The episode lasted approximately 1.5 minutes, no treatment was given. Patient was tested for Covid post vaccination, she underwent Covid-19 PCR Test (Nasal Swab) on 04Jan2021 and on 07Jan2021, both with negative results. She also underwent a Covid-19 PCR Test on unknown unknown date in Jan2021 with unknown results. Patient recovered on 31Dec2020 from the events.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product event most likely due to patient underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,OTH,; LAMICTAL;,,Medical History/Concurrent Conditions: Epilepsy (well controlled with meds.),,,"['Aura', 'Condition aggravated', 'Focal dyscognitive seizures', 'Hypotonia', 'Muscular weakness', 'Pain in extremity', 'SARS-CoV-2 test negative', 'Syncope']",1,PFIZER\BIONTECH, 947550,ID,29.0,F,"spontaneous rupture of membranes at 36-0 weeks; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable physician. This physician reported information for both mother and fetus/baby. This is the maternal report. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (left arm) on 18Dec2020 and 08Jan2021 at a single dose for COVID-19 immunization. Medical history included cold sores, no active cold sore at time of labor. On an unspecified date, it was reported that a healthy 29-year-old G1P0 with good prenatal care and no pregnancy complications who had spontaneous rupture of membranes at 36-0 weeks, one day after her second Pfizer CoVid vaccine (09Jan2021). She felt well after her vaccine and had no symptoms today. The mother reported she became pregnant while taking BNT162B2. The patient takes prenatal vitamins. The mother was 33 Weeks pregnant at the onset of the event. The mother was due to deliver on 06Feb2021. Therapeutic measures were taken as a result of premature rupture of membranes. The outcome of the event was recovering. Information about Batch/Lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of spontaneous rupture of membranes due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Cold sores,,,"['Exposure during pregnancy', 'Premature rupture of membranes']",1,PFIZER\BIONTECH,OT 947552,CA,47.0,F,"Within 15 minutes, I began feeling dry throat; Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside my throat.; it felt like I had a lump inside my throat.; Then I began to have difficulty swallowing my saliva.; difficulty breathing; very groggy; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), intramuscular in left arm on 20Dec2020 at a single dose for COVID-19 immunization. Vaccination was administered in a hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included hypertension, overweight, and known allergies to bee stings and hair dye. The patient's concomitant medication included multivitamins. On 20Dec2020, within 15 minutes, the patient began feeling dry throat, then itching, then it felt like she had a lump inside her throat. Then she began to have difficulty swallowing her saliva. And then the lump inside her throat started to feel larger and larger. By this time, the doctor had already injected the patient with Epipen and the pharmacist injected her with Solumedrol and she still felt as if she was having difficulty breathing and then she was taken to ER and she really can't remember too much after that. The patient was very groggy and then was discharged from ED about 9:30 pm. The outcome of the events was recovered on an unknown date. Treatment for the events included epinephrine, methylprednisolone, diphenhydramine. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling dry throat, itching, felt like having lump inside her throat, having difficulty swallowing saliva, difficulty breathing and very groggy cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,12/20/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Bee sting hypersensitivity; Hair dye sensitivity; Hypertension; Overweight,,,"['Dry throat', 'Dysphagia', 'Dyspnoea', 'Sensation of foreign body', 'Somnolence', 'Throat irritation']",1,PFIZER\BIONTECH,OT 947553,CO,26.0,F,"significant swelling to lymph nodes under armpit of injection side (L arm); This is a spontaneous report from a contactable consumer. A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at the left arm on 09Jan2021 08:00 at SINGLE DOSE for COVID-19 immunization at a hospital. Medical history included asthma, food allergy with peanuts and pine nuts. No known medication allergy. The concomitant medications included albuterol and unspecified multivitamin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) at the left arm on 19Dec2020 08:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient was not pregnant. On 10Jan2021 16:00, the patient noted significant swelling to lymph nodes under armpit of injection side, swelling in the left armpit lymph nodes began approximately 32 hours after injection. Swelling measuring approximately size of a ping pong ball. At time of this reporting (approximately 40 hours post-injection) lymph node swelling still persists, with no change in size. The patient did not receive any treatment for the events. The patient has not recovered from the events. No follow-up attempts are needed. No further information expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,ALBUTEROL [SALBUTAMOL],,Medical History/Concurrent Conditions: Asthma; Food allergy,,,['Lymphadenopathy'],2,PFIZER\BIONTECH, 947557,TX,40.0,F,"Patient was tested for Covid post vaccination/ Covid test on 28Dec2020 and resulted positive; Patient was tested for Covid post vaccination/ Covid test on 28Dec2020 and resulted positive; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK7530) solution for injection, intramuscular on left arm on 16Dec2020 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. It was reported that patient was tested for Covid post vaccination. Nasal swab for Covid test was done on 28Dec2020 and resulted positive. Outcome of the event was unknown. No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/28/2020,12.0,PVT,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH,OT 947559,WI,33.0,F,"had a metallic taste; turned to swollen tongue; hives around chest and neck; difficult to breathe; tachycardia; This is a spontaneous report from a contactable other HCP (Patient). A 33-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL 3248), via an unspecified route of administration at right arm on 07Jan2021 16:15 at single dose for covid-19 immunization. Vaccine was administered at hospital. Known allergies included cyclobenzaprine and dairy latex. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 10 mg, gabapentin 300 mg, venlafaxine 150 mg. No other vaccine in four weeks. Three minutes after vaccination the patient had a metallic taste, turned to swollen tongue, hives around chest and neck, difficult to breathe, and tachycardia on 07Jan2021 16:18. The events resulted in Emergency room/department or urgent care. Treatment received included Epinephrine, methylprednisolone sodium succinate (SOLU-ME dork) and famotidine (PEPCID) also diphenhydramine HCl (BENADRYL). The outcome of the events was unknown.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for events metallic taste, swollen tongue, hives, difficulty breathing and tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,PVT,ADDERALL; ;,,Medical History/Concurrent Conditions: Latex allergy; Milk allergy,,,"['Dysgeusia', 'Dyspnoea', 'Swollen tongue', 'Tachycardia', 'Urticaria']",1,PFIZER\BIONTECH, 947572,,,U,tested (COVID-19 virus test) positive after receiving first dose of vaccine; tested (COVID-19 virus test) positive after receiving first dose of vaccine; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that patient tested (COVID-19 virus test) positive after receiving first dose of vaccine. It was also reported that they are looking for administration recommendations following receipt of monoclonal antibodies and interval information. Outcome of the events was unknown. Information of the lot number/batch number was requested.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 947573,FL,,F,"really extreme high blood pressure (202/104); feeling very sick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 04Jan2021 at a single dose for COVID-19 immunization. Medical history included strokes and bleeding disorder (gene that makes blood clot). The patient's concomitant medications were not reported. The patient experienced really extreme high blood pressure (202/104) and feeling very sick on an unspecified date. The clinical course was reported as: The patient received the vaccine on 04Jan2021 and experienced a lot of side effects, the most concerning of which was really extreme high blood pressure. The patient went to the emergency room (ER) on an unspecified date and her blood pressure was 202/104 on an unspecified date. The patient stated that she had been very sick and in bed for days. The patient had a follow-up appointment with her doctor on the day of the report. The clinical outcome of really extreme high blood pressure (202/104) and feeling very sick was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,,,UNK,,,Medical History/Concurrent Conditions: Congenital coagulopathy (gene that makes blood clot); Stroke,,,"['Hypertension', 'Malaise', 'Mobility decreased']",UNK,PFIZER\BIONTECH, 947589,NY,64.0,F,"tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiration date: 31Mar2021), via intramuscular on 21Dec2020 at 0.3 mL single in left deltoid for preventative. Medical history included she only had one kidney from 25Feb2020. There were no concomitant medications. It was reported that the patient was supposed (was scheduled) to get her second dose today (11Jan2021) but this past weekend she tested positive for COVID on 09Jan2021. The patient wanted to know if it would affect getting the second dose of the vaccine. The patient supposed to be quarantining right now and she was not symptomatic. On 09Jan2021 she found out she was positive for covid. The outcome of the event was unknown.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,01/09/2021,19.0,UNK,,,Medical History/Concurrent Conditions: Kidney disorder (Patient Medical comments: Only has one kidney),,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH,OT 947593,,,M,"he is infected with COVID-19; he is infected with COVID-19; This is a spontaneous report from a contactable nurse (patient). A male patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called to find out if there should be a delay in the second dose because he was infected with COVID-19 on an unspecified date. His second dose was scheduled on 13Jan2021 and he was wondering if he should continue in 2 days. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 947594,,,F,"she had a little bleed in the blood vessel of her left eye; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asking if bleeding of the eye was an adverse reaction to bnt162b2. Patient received the Covid vaccine on 21Dec2020 and on the 27Dec2020, she had a little bleed in the blood vessel of her left eye. She was supposed to get the second vaccine today (11Jan2021) at 12:30. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/27/2020,6.0,UNK,,,,,,['Eye haemorrhage'],1,PFIZER\BIONTECH, 947595,,60.0,M,"got the first dose of the vaccine and on 25Dec2020, he started getting symptoms of possible covid; got the first dose of the vaccine and on 25Dec2020, he started getting symptoms of possible covid; This is a spontaneous report from a contactable pharmacist. A 7-decade-old (65 years or 66 years) male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The stated, ""my uncle got the first dose of the vaccine and on 25Dec2020, he started getting symptoms of possible Covid. He got tested for covid today (11Jan2021). He's supposed to get the second dose on 15Jan2021. If he is positive for covid, what does that mean for his second dose? If he is positive, and waits for quarantine, then he wouldn't be able to get the second dose until day 36."" The outcome of the events was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/25/2020,,,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 947602,,,F,"On (Dated) tested positive for Covid; On (Dated) tested positive for Covid; On (Dated) tested positive for Covid; Felt run down; This is a spontaneous report from a contactable other health professional (HCP). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at a single dose (first dose) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got her first dose on 28Dec2020 and on 07Jan2021, she felt run down so she decided to get tested for COVID. On 09Jan2021, she tested positive for COVID. Her second dose is due 18Jan2021 and she needed to know if it is ok for her to get her second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Jan2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (tested positive for COVID) with BNT162b2 can not be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/07/2021,10.0,UNK,,,,,,"['Feeling abnormal', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 947603,,,M,"Caller tested positive on 05Jan2021.; Caller tested positive on 05Jan2021.; Caller tested positive on 05Jan2021.; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received the first dose of the COVID 19 vaccine on 29Dec2020, second dose is due on 20Jan2021. Patient tested positive on 05Jan2021. Patient wanted to know if he should get the second shot and if he chooses to wait the 90 days, would he need to start over. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Jan2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (tested positive) with BNT162b2 can not be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/05/2021,7.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 947609,,,U,"13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is second of 13 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Coronavirus test positive'],UNK,PFIZER\BIONTECH, 947611,,,U,"13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is third of 13 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Coronavirus test positive'],UNK,PFIZER\BIONTECH, 947612,,,U,"13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is fourth of 13 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Coronavirus test positive', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 947613,,,U,"13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is fifth of 13 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Coronavirus test positive'],UNK,PFIZER\BIONTECH, 947614,,,U,"13 People, who were applied the vaccine previously, were corona positive after a week; 13 People, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is 6th of 13 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Coronavirus test positive'],UNK,PFIZER\BIONTECH, 947615,,,U,"13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is 7th of 13 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Coronavirus test positive'],UNK,PFIZER\BIONTECH, 947616,,,U,"13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is 8th of 13 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Coronavirus test positive'],UNK,PFIZER\BIONTECH, 947617,,,U,"13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is 9th of 13 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 : same reporter, similar suspect drug and event; different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Coronavirus test positive'],UNK,PFIZER\BIONTECH, 947618,,,U,"13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is tenth of 13 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Coronavirus test positive', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 947619,,,U,"13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is 11th of 13 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Coronavirus test positive'],UNK,PFIZER\BIONTECH, 947620,,,U,"13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patient. This is the 13th of 13 report. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, batch/lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week. on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Coronavirus test positive'],UNK,PFIZER\BIONTECH, 947622,,,F,"She tested positive for Covid-19 a week later after receiving the first dose of the vaccine; She tested positive for Covid-19 a week later after receiving the first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on 29Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took the first dose of Covid-19 vaccine on 29Dec2020. She tested positive for Covid-19 a week later after receiving the first dose of the vaccine. She is scheduled to get the second dose on 19Jan2021 and she was asking what to do. The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 947625,CA,,F,"tested positive for COVID; tested positive for COVID/fatigue, headache, body aches again; allergies were flaring up; Coughing; congestion; body aches; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse (female) reported that a female patient of an unspecified age received first dose of bnt162b2, via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for covid on 31Dec2020, coughing, congestion, body aches on 24Dec2020, fatigue, headache, allergies were flaring up on 28Dec2020. The caller got her first COVID-19 injection on 21Dec2020. She didn't have symptoms until 2 days after the vaccine. She then experienced coughing, congestion, body aches, but no fever. Then the next day, she felt fine. On 28Dec2020, she thought her allergies were flaring up. She started to feel fatigue, headache, body aches again. She went and got tested for the virus. She tested positive on 31Dec2020. Caller was due for a second vaccine on 11Jan2021. She was to remain in quarantine until 10Jan2021. Caller wanted to know should she get her second shot on 11Jan2021 or should she wait. The patient underwent lab tests and procedures which included Covid-19: positive on 31Dec2020. The outcome of events for tested positive for covid, fatigue, headache and allergies were flaring up was unknown, for other events was resolving. No further information was obtained. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events drug ineffective and COVID-19 cannot be excluded based on a compatible temporal relation between vaccination and onset of events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/24/2020,3.0,UNK,,,,,,"['Cough', 'Fatigue', 'Headache', 'Pain', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 947637,GA,,M,"short of breath; aching so bad again; was still short of breath, getting worse, aching so bad again; choking; got as cold as ice; throat was real swollen; started itching terribly; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK4176), via an unspecified route of administration on 06Jan2021 single for COVID-19 immunization. Medical history included hypertension and had 4 heart attacks. The patient's concomitant medications were not reported. The patient just had the Covid 19 Vaccine first shot. After the shot he went to the dining room to get some lunch. He was reading since 'calculative'. He started itching terribly. Onset date for started itching terribly was reported as 06Jan2021. He got as cold as ice. He started getting real short of breath, he was choking but he managed to get them out of his throat. His throat was real swollen and choked. He went back to the clinic and the Nurse took him straight to the emergency room. He was there in his wheelchair freeze in and crawling himself, struggling to breathe for almost 25 minutes before the Nurse finally came in and helped him get him on the stretcher. She took his time, she got the IV started and gave him a steroid a shot and Benadryl. He did not know the dosage and some capsules. He did not know why the capsules and he was still struggling for a while but he found day tough for about an hour. When he came too he was still short of breath, getting worse, aching so bad again. He was struggling to breathe, he was still having some breathing problem, some choking and aching. The events was still short of breath, getting worse, aching so bad again were serious as hospitalization. Laboratory work: Work was normal. The COVID Test was negative. The outcome of events short of breath and started itching terribly was not recovered while for other events were unknown.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/06/2021,01/06/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Heart attack (had 4 heart attacks); Hypertension,,,"['Choking', 'Dyspnoea', 'Feeling cold', 'Laboratory test normal', 'Pain', 'Pharyngeal swelling', 'Pruritus', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 947639,OK,,U,"dehydration; This is a spontaneous report from a contactable Nurse. A patient of unknown age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. After vaccination on an unknown date, the patient went to ER and was diagnosed with dehydration. Patient was hydrated and recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,['Dehydration'],1,PFIZER\BIONTECH, 947642,PA,66.0,M,"died two days after receiving the vaccine; Fever; This is a spontaneous report from a contactable consumer (patient's stepchild). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 07Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included an unspecified statin. The patient experienced fever on 08Jan2021. The patient died two days after receiving the vaccine on 09Jan2021, which was reported as fatal. The clinical course was reported as follows: The patient had a fever the day after getting the vaccine and then he just died in the middle of night. It was reported that it was not clear what exactly happened, but they are looking into this. The clinical outcome of fever was unknown and of died two days after receiving the vaccine was fatal. The patient died on 09Jan2021. The cause of death was not reported. An autopsy was not performed (was reported to be taking place soon). The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: died two days after receiving the vaccine",Yes,01/09/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,UNK,,,,,,"['Death', 'Pyrexia']",2,PFIZER\BIONTECH, 947662,MN,84.0,M,"Accelerated decline in condition with decreased input, decreased responsiveness, somnolence, and death",Yes,01/06/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,SEN,"Terazosin 5mg po HS, Metoprolol 12.5 mg BID, Depakote 375mg BID, Hydrochlorothiazide 12.5mg Q am",no acute illnesses,"Alzheimers, Dementia without behaviors, Chronic Venous hypertension, Aphasia, Benign Prostatic Hypertrophy, Aphasia, Osteoarthritis",,Lisinopril,"['Death', 'General physical health deterioration', 'Hypophagia', 'Hyporesponsive to stimuli', 'Somnolence']",1,MODERNA,IM 947667,VA,37.0,F,Received vaccine in left deltoid within minute felt throat tighten self administered personal epi pen.,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,,,,,latex,['Throat tightness'],UNK,PFIZER\BIONTECH, 947687,MD,52.0,F,"I had no side effects after my vaccine on 12/24/20 until 1/8/21. On Friday, 1/8/21 at 830pm I began with severe abdominal pain, low grade fever, nausea and loss of appetite. My abdominal pain persisted and worsened over the next 24-36hours. I presented to the ER on Sunday, January 10, 2021 at 8am with severe right lower quadrant pain, pelvic pain, nausea and low grade fever. I was promptly diagnosed with appendicitis and taken to the OR at approximately 2pm on the same day. In the OR my appendix was gangrenous, there was pus in the pelvic area nd fluid in my peritoneum. My appendix was not ruptured. My appendix was removed as well as part of the omentum. I remained in the hospital on IV Metronidazole and Ciprofloxacin for 2 days and was discharged on 1/13/21 at 9pm. I am continuing to recvoer at home on the same 2 antibiotics in oral form. I have a JP drain that is still in place. Of note I had two negative COVID 19 tests on 1/9/21 and 1/10/21. Both were PCR tests.",Not Reported,,Yes,Yes,3.0,Not Reported,N,12/24/2020,01/08/2021,15.0,PVT,Synthroid 112mcg once per day,Recent doagnosis of SVT (12/20),"Thyroidectomy 2/14, now on replacement therapy Overweight",,None,"['Abdominal pain', 'Abdominal pain lower', 'Activated partial thromboplastin time', 'Appendicectomy', 'Ascites', 'Chest X-ray', 'Complicated appendicitis', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram pelvis abnormal', 'Culture negative', 'Decreased appetite', 'Drain placement', 'Full blood count', 'Metabolic function test', 'Nausea', 'Omentectomy', 'Pathology test', 'Pelvic abscess', 'Pelvic pain', 'Prothrombin time', 'Pyrexia', 'SARS-CoV-2 test negative', 'Troponin', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 947718,TX,24.0,F,Tingling and throat swelling to Moderna COVID-19 Vaccine EUA,Not Reported,,Yes,Not Reported,,Not Reported,,01/14/2021,01/14/2021,0.0,UNK,,,,,,"['Paraesthesia', 'Pharyngeal swelling']",1,MODERNA,IM 947841,MI,83.0,M,"Patient had no immediate effects from the vaccine, but died approximately 8 hours after receiving first dose of vaccine.",Yes,01/14/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,SEN,,,,,,['Death'],1,MODERNA,IM 947860,AR,48.0,F,"positive for Covid; positive for Covid; This is a spontaneous report from a contactable healthcare professional (patient). A 48-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiration date unknown), via an unspecified route of administration in right deltoid, on 18Dec2020 07:15 at a single dose for Covid-19 immunization. Medical history included ongoing hypothyroidism and hysterectomy. Concomitant medications included estradiol (taking after hysterectomy) and levothyroxine for hypothyroidism, both ongoing. The patient has no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient stated that she received the Covid vaccine mid- Dec2020. She stated she was supposed to receive the 2nd dose 2 days ago, 06Jan2021. On 03Jan2021, she started feeling bad the day before testing positive, went to urgent care to be tested, thought she had the flu. She tested positive for Covid on Monday 04Jan2021, so she has been in quarantine. She was unable to receive her 2nd dose because she was in quarantine. She wanted to know if it's ok to delay the second dose or if she needs to re-start the series. The reporter assessed the event relatedness was unknown, patient stated that she doesn't know the causality, she has not been in contact with anyone that was known to be positive, but she is a healthcare worker who sees multiple patients a day, so one of them could have been asymptomatic. Outcome of the events was not recovered.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,01/04/2021,17.0,UNK,;,Hypothyroidism,Medical History/Concurrent Conditions: Hysterectomy,,,"['Feeling abnormal', 'Influenza like illness', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 947867,,,M,"received first dose of bnt162b2/by the 3rd (03Jan2021), he was diagnosed as covid positive; received first dose of bnt162b2/by the 3rd (03Jan2021), he was diagnosed as covid positive; patient lost his sense of smell and taste; patient lost his sense of smell and taste; This is a spontaneous report from a contactable nurse (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 17Dec2020 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient reported he needs advice on the second dose of the vaccine. Patient stated he is an ER nurse and received the first dose of the vaccine on 17Dec2020. On 31Dec2020, patient lost his sense of smell and taste and by the 3rd (03Jan2021), he was diagnosed as covid positive. The patient underwent lab tests and procedures which included Covid test: positive on 03Jan2021. The patient is asking how safe it is to get the second dose now and if there's a time period that he should wait so that he can get the second dose. Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded. Further information like diagnostic detection of virus genetic material or virus protein antigen needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/31/2020,14.0,UNK,,,,,,"['Ageusia', 'Anosmia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 947888,,,F,"she tested positive for COVID-19 on Monday 27Dec2020; she tested positive for COVID-19 on Monday 27Dec2020; This is a spontaneous report from a contactable nurse (patient herself). A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer-Biontech Covid-19 Vaccine, lot/batch number and expiry date not reported), via an unspecified route of administration on 19Dec2020 at single dose, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was scheduled for her second dose today 09Jan2021. However, she tested positive for COVID-19 on Monday, 27Dec2020. She stated that she has still some of the symptoms of COVID-19 even though she has been declared fit to work. She was asking if she could take the second dose today. Information about batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported event ""she tested positive for COVID-19"".",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/27/2020,8.0,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 947976,NC,70.0,M,"Headache, body aches, cough - began 1/10/21 - 3 day s/p Pfizer 1st dose vaccine WAS NOT TESTED for COVID - his dr said not necessary - ""his wife had it, he had it!""",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/10/2021,3.0,PUB,"Metformin, lisinopril, metoprolol, glipizide, fenofibrate","DM, HTN","DM, HTN, Bladder stones/prostate later tx in fall 20",,NKDA,"['Cough', 'Headache', 'Pain']",UNK,PFIZER\BIONTECH,IM 947982,,,U,"guillain barre syndrome; Initial information regarding an unsolicited valid serious courtesy case received from a pharmacist via Pfizer Pharmaceuticals (Reference number: 2021003640) on 06-Jan-2021. This case involved an adult patient of an unknown gender who experienced Guillain Barre syndrome, after receiving influenza vaccine. Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect influenza vaccine (other details unknown) produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination. On an unknown date (unknown latency), the pharmacist asked information on Pfizer coronavirus infectious disease (COVID-19) vaccine. Pharmacist asked if Pfizer coronavirus infectious disease (COVID-19) vaccine could be administered to any person who had a positive history of developing Guillain Barre Syndrome after receiving an influenza vaccine (Guillain Barre syndrome). Final diagnosis was Guillain Barre syndrome. No relevant laboratory details were provided. The event of Guillain Barre syndrome was assessed as medically significant as per the important medical event list. It was not reported if the patient received a corrective treatment. Outcome of the event of Guillain Barre syndrome was reported as unknown. There will be no information available on the batch number for this case.; Sender's Comments: This case involved an adult patient of an unknown gender who presented with Guillain Barre syndrome after receiving influenza vaccine (produced by unknown manufacturer). Time to onset is unknown. Although, medical history, comorbidities, concomitant medications, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Guillain-Barre syndrome'],UNK,UNKNOWN MANUFACTURER,OT 947992,CA,41.0,F,"About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongue and back of my throat. I waited to see if it would go away and then a couple minutes later noticed my lips started itching and swelling and from there it just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth throat & lips felt swollen and itching and she looked and said it was full blown anaphylaxis reaction. Administered EpiPen, benadryl and called ambulance where they took me to medial emergency department.",Not Reported,,Yes,Not Reported,,Not Reported,U,01/13/2021,01/13/2021,0.0,WRK,"Armour thyroid 120mg, seasonal birth control, Allegra 180mg, Singulair 10mg, Protonix 40mg, Midodrine 2.5mg, Trokendi XR 200mg, Gabapentin 300mg, Benadryl 50mg, Vitamin B121ML/week, B6 50mg daily, D3 5,000 daily, apple cider vinegar gummies",,Migraines Hashimoto's hypothyroidism Dysautonomia/POTS,,Sulfa Tree nuts,"['Anaphylactic reaction', 'Lip pruritus', 'Lip swelling', 'Mouth swelling', 'Oral pruritus', 'Pharyngeal swelling', 'Throat irritation', 'Tongue pruritus']",1,PFIZER\BIONTECH,IM 948001,,30.0,F,"chest pressure, SOB, scratchy throat, light headedness, hoarse voice 12/29 - about 15 min after receiving the vaccine employee reported mild chest pressure/pain, hoarse voice, SOB, light-headedness, and scratchy throat. (She was given the vaccine in the ED because of a history of anaphylaxis with taking antibiotics). Her physical examination and vital signs were normal. No evidence of swelling to lips, tongue or throat. No treatment was required. Employee was observed for 4 hours and discharged to home. She was diagnosed with a minor allergic reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Chest discomfort', 'Chest pain', 'Dizziness', 'Dysphonia', 'Dyspnoea', 'Throat irritation']",1,PFIZER\BIONTECH,IM 948022,,41.0,F,"Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, joint aches, photophobia, headaches, fever, hypertension Narrative: Employee stated H/A, body aches, joint aches, photopobia, fever, hypertension BP 170/100, employee sent to to ER due to elevated b/p. denies any other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/29/2020,8.0,OTH,,,,,,"['Arthralgia', 'Blood pressure increased', 'Headache', 'Hypertension', 'Myalgia', 'Pain', 'Photophobia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 948035,,70.0,M,"Dizziness, Tachypnea, NauseaVomiting, HYPERtension, no other events occured Narrative: Employee c/o dizziness and nausea after 15 minutes of sitting, and then using the restroom. Sits back down and vs obtained. b/p 212/128 manual and machine. pulse and o2 normal. Patient continues to feel poorly, wants to lie down. Patient tachypneic, with some SOB. Has high b/p baseline, but says he took his b/p meds this AM. Hasn't had reaction to vaccines previously. Epi administered and 911 called, as patient agrees to this. A&O,pleasant and anxious. Transport to hospital for eval with paramedics.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,12/28/2020,,OTH,,,,,,"['Anxiety', 'Dizziness', 'Dyspnoea', 'Feeling abnormal', 'Hypertension', 'Nausea', 'No reaction on previous exposure to drug', 'Tachypnoea', 'Vomiting']",1,PFIZER\BIONTECH,IM 948080,AK,72.0,F,"Error with diluent, sterile water used",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,,,PVT,NORCO; EFFEXOR ER; ZOCOR; AMBIEN; NORVASC; PRILOSEC; NEURONTIN; TRELEGY ELLIPTA; CHANTIX STARTING MONTH PAK; VENTOLIN HFA; Vitamin B-12; Vitamin D-3; COZAAR; FOSAMAX; aspirin; FLONASE; LYRICA,"HTN, low back pain, hyperlipids","Barrett's esophagus, 10/23/2013; COPD; Depression, 10/06/2020; GERD, 06/10/2013; Hypertension; Insomnia, 06/10/2013; Low back pain, 03/30/2012; Lumbar disc disease, 06/10/2013, Malignant Neoplasm of Nipple and Areola of female breast, 08/15/2011, Obstructive Sleep Apnea, 2/2008; Osteoporosis, 02/21/2016; Peripheral vascular disease, 07/16/2012; Sinusitis, Chronic, 10/06/2020; Tobacco abuse, 03/16/2017",,"Pollen extract; Ramipril, hives, cough",['Product preparation error'],1,PFIZER\BIONTECH,IM 948082,KS,39.0,F,"Patient had just recovered from COVID and ended quarantine on 1/1/21. On 1/4/21, she received the first COVID vaccination. While driving home on 1/6/21, she experienced an MI diagnosed in the emergency room 30 minutes later. She was admitted to the hospital and underwent a heart catheterization and received a STENT. She had previous cardiogenic shock in 2003.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/04/2021,01/06/2021,2.0,PVT,,COVID (+) 14 days prior with quarantine ending on 1/1/21,Cardiogenic shock in 2003 related to substance usage,,,"['Catheterisation cardiac', 'Myocardial infarction', 'Stent placement']",1,MODERNA,IM 948089,AK,76.0,F,"Error with diluent, sterile water used",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,,,PVT,"LANTUS SOLOSTAR, CRESTOR, LASIX, NORVASC, B-12, METAMUCIL FIBER,",0,"Carotid stenosis, Colon polyps, Diabetes mellitus, type II, Esophageal Stenosis, GERD (gastroesophageal reflux disease), Healthcare maintenance, Hyperlipidemia, Hypertension, Neck pain, bilateral, Obstructive sleep apnea, Osteopenia, Vision loss of right eye",,NKA,['Product preparation issue'],1,PFIZER\BIONTECH,IM 948118,TX,33.0,F,Pfizer-BioNTech COVID- 19 Vaccine EUA Received communication that patient experienced a stroke and received alteplase at a non-facility (Medical Center) 5 days after receiving COVID-19 vaccination.,Not Reported,,Not Reported,Yes,,Not Reported,,01/06/2021,01/11/2021,5.0,PVT,,,,,Flagyl,['Cerebrovascular accident'],1,PFIZER\BIONTECH,IM 948124,OH,80.0,F,"24Hr, 01/09/2021-post vaccine found in room on floor- very shaky and SOB, again later the same day-incontinent urine, confused, pain in extremities with movement, sent out to hospital. returned same evening. 01/12/2021- difficulty communicating, confused- sent out to hospital, returned same day. 01/15/2021- symptoms improved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,SEN,MANTOUX; MAGNESIUM OXIDE; MULTI-VITAMIN; OSTEO BI-FLEX; TRELEGY ELLIPTA; VITAMIN C; VITAMIN D3; VITAMIN E; DEPAKOTE; METOPROLOL TARTRATE; VENTOLIN HFA; ZYRTEC; TYLENOL; TUMS; COLACE; ATROVENT; LOPERAMIDE; MELANTONIN;,,HTN; COPD; OSTEOARTHRITIS; BIPOLAR; HX OF BLOOD CLOTS,,,"['Confusional state', 'Dysarthria', 'Dyspnoea', 'Nervousness', 'Pain', 'Urinary incontinence']",1,PFIZER\BIONTECH,IM 948150,OH,84.0,M,"increase weakness and fatigue, weakness in extremities, incontinent, jerky arm movements, within first 24 hours, continue to decline sent to hospital returned weaker, within 24 hrs hours BP dropped, low pulse oximeter reading, diaphoretic, lung sounds diminished, loss consciousness and passed away. 01-12-2021",Yes,01/12/2021,Not Reported,Yes,2.0,Not Reported,,01/08/2021,01/09/2021,1.0,SEN,MANTOUX; ACIDOPHILUS; ALPHA LIPOIC ACID; ASPIRIN EC; BUMETANIDE; C-GEL; ESCITALOPRAM; PROSCAR; KRILL OIL; LEVOTHYROXINE; MAGOX; K-DUR; FLOMAX; VITAMIN B-12; VITAMIN D3; LIORESAL; CALCIUM CITRATE; COCONUT OIL; CURCUMIN; PROAMATINE; PRESERVIS,"pneumonia,",A-FIB; HYPERCHOLESTEROLEMIA; CKD 3; BPH; DEPRESSION; CERVICAL DISC DISORDER; SPINAL STENOSIS; BLADDER; COPD,,"ibuprofen,sulfa antibiotics","['Asthenia', 'Blood pressure decreased', 'Breath sounds abnormal', 'Death', 'Dyskinesia', 'Fatigue', 'Hyperhidrosis', 'Incontinence', 'Loss of consciousness', 'Muscular weakness', 'Oxygen saturation decreased']",1,PFIZER\BIONTECH,IM 948162,OH,91.0,F,"01/11/2021- Found lying on bed in apartment, incontinent, lethargic, unable to respond to questions, unable to do hand grasps. sent to hospital. 01/14/2021- remains in hospital- confusion and disorientation continues, poor verbal skills, limited ability to feed self, out of bed to sit in chair. uncertain of return to facility status.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/08/2021,01/11/2021,3.0,SEN,MANTOUX; COPAXONE; ASPIRIN; CARDIZEM CD; SYNTHROID; LEVOTHYROXINE; PRILOSEC; VITAMIN B; KEPPRA; HIPREX; METOPROLOL; VIMPAT; LIORESAL; NEURONTIN; LIPITOR; MELANTONIN; REMERON; REQUIP; XANAX; ZOFRAN,,MULTIPLE SCLEROSIS; POLYMYALGIA; RHEUMATICA; HYPOTHYROIDISM; HTN; SEIZURE DISORDER; HISTORY OF CVA; NEUROGENIC BLADDER,,,"['Confusional state', 'Disorientation', 'Illiteracy', 'Incontinence', 'Lethargy', 'Loss of personal independence in daily activities', 'Motor dysfunction', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 948164,MI,77.0,M,"Abdominal pain, Headaches, chest pain, loss of appetite, confusion, elevated liver enzymes 1/8-1/15/21",Yes,01/15/2021,Not Reported,Yes,,Not Reported,U,01/06/2021,01/08/2021,2.0,SEN,"Multivitamin, Zinc, Doxycycline, Ultram, Xanax, Pepcid, Nitroglycerin, Tylenol, Simethicone, Metoprolol Succinate ER, Loperamide, Levothyroxine,",UTI and Sinus infection,"Encephalopathy, Type 2 diabetes, Morbid obesity, hypothyroidism, CKD, HTN, iron deficiency anemia, Atrial fibrillation, IBS,",,,"['Abdominal pain', 'Chest X-ray', 'Chest pain', 'Computerised tomogram', 'Computerised tomogram abdomen', 'Confusional state', 'Decreased appetite', 'Full blood count', 'Headache', 'Hepatic enzyme increased', 'Metabolic function test']",1,MODERNA,IM 948171,OH,69.0,M,"01-09-2021 Very confused, nauseous, sweating profusely. sent to hospital- admitted with encephalitis, severe cognition decline. 01-13-2021 still in hospital, cognition Improved.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/08/2021,01/09/2021,1.0,SEN,Norvasc; folic acid; multi-vitamin; protonix; zoloft; vitamin B1; vitamin B-12; Bupropion HCL SR; Buspirone HCL; Ecotrin; Lipitor; Zestril; Desyrel; Acetaminophen; Atarax; Nitrostat; Ventolin HFA,,Hyperlipidemia; HTN; CAD; DDD; Osteoarthritis; Depression with anxiety; AAA; Dementia; Hyponatremia; Tremors; Alcoholism,,none,"['Cognitive disorder', 'Confusional state', 'Encephalitis', 'Hyperhidrosis', 'Nausea']",1,PFIZER\BIONTECH,IM 948181,MI,89.0,M,Death Chest pain; irreg heart rhythm; evening of vaccine; death on toilet on 1/13/21,Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,"ANORA, Albuterol, Flovent, Bumex, Carvediol; omeprazole",,"COPD, CHF, renal; ASCVD; MI hx",,0,"['Chest pain', 'Death', 'Heart rate irregular']",UNK,MODERNA, 948194,IA,32.0,F,6:00 am on 24th - checked temp. wanting to make sure it wasn't high and it was 99.1 and I decided to take one capsule of Tylenol extra Strength. Took on empty stomach and felt nauseated and went and vomited. No other reactions other than fatigue and low appetite and sore arm the rest of the day. Ate less that day and so did get nausea off and on during the day - but not as severe and no more vomiting. 25th - everything resolved. 6/16/21 - estimated date of delivery. 1st pregnancy. Has been a normal pregnancy.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,OTH,Prescription: Lexapro - 10 mg daily Prenatal Vitamin Tylenol - that morning for taking vaccine,none,none,,Amoxicillin,"['Decreased appetite', 'Exposure during pregnancy', 'Fatigue', 'Nausea', 'Pain in extremity', 'Vomiting']",1,MODERNA,IM 948206,PA,35.0,F,"Initially headache and body aches. Within 24 hours developed chest pain, dyspnea on exertion and shortness of breath. Patient still currently hospitalized.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/11/2021,01/12/2021,1.0,WRK,,,Asthma,,,"['Chest pain', 'Dyspnoea', 'Dyspnoea exertional', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 948224,AK,70.0,F,"Error with diluent, sterile water used",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/01/2021,,,PVT,"RESTASIS; albuterol; CYMBALTA; SYNTHROID; COZAAR; PRAVACHOL; SINGULAIR; EMLA; chlorthalidone; SOMA; ADVAIR, WIXELA INHUB; PREVACID; MIRALAX; CBD oil; MOBIC; trospium; COREG; CYMBALTA; PROAIR RESPICLICK; aspirin;",,"Sarcoidosis of Lung; Heart palpitations; Acquired hypothyroidism; Cervicalgia; Chronic allergic rhinitis; GERD; Iliotibial band syndrome affecting right lower leg; Mixed hyperlipidemia; Special screening for malignant neoplasms, colon; Dysphagia; Osteoarthritis of left knee; Hashimoto's disease; Superficial thrombophlebitis; Migraines; Breast cancer screening; History of blood transfusion; History of pulmonary function tests; Nodule of right lung; Urinary tract infection without hematuria; S/P total knee arthroplasty; Primary osteoarthritis of left knee; Chronic bilateral low back pain without sciatica; Leg length inequality; Sacroiliac pain; Compression deformity of vertebra; Presbyopia; Pseudophakia of both eyes; Degeneration of lumbar intervertebral disc; Inflammation of sacroiliac joint; Lumbar spondylosis; Spinal stenosis of lumbar region; Lower extremity edema; Dry eyes",,"Epinephrine, Anaphylaxis; Preservative in Epi; Sodium metabisulphite; Lidocaine, Hives, Shortness Of Breath; Preservative in some lidocaines; Sodium metabisulphite preservative, Anaphylaxis; Shellfish, Hives, Shortness Of Breath; Clams and lobster; Sulfa Antibiotics, Swelling; Gabapentin, tremors; Tape, rash;","['Medication error', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 948228,FL,78.0,M,Patient reportedly expired the day following receipt of the vaccine.,Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,,01/12/2021,01/13/2021,1.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 948243,,64.0,F,"Observed in her room having seizure activity and unresponsive to stimuli. BP of 200/120, oxygen level dropped to 86%, HR was 116. She was transferred from Hospital A and later transferred to Hospital B and placed on a ventilator. This remains her current status",Not Reported,,Yes,Yes,,Not Reported,U,01/12/2021,01/13/2021,1.0,SEN,,,"Epilepsy, Congenital Hydrocephalus, Essential Hypertension, Major depressive disorder, Heart Failure, Type II Diabetic Mellitus without complications,",,No known drug allergies,"['Condition aggravated', 'Mechanical ventilation', 'Oxygen saturation decreased', 'Seizure', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 948285,MS,50.0,F,"We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on staff at the clinic and came in for her 1st dose of the Pfizer/BioNTech COVID vaccine. 10 minutes post-vaccination, patient started experiencing SOB, tingling fingers and face, and swelling of her lips and tongue. She moved herself outside to cooler air and then sent someone back inside to ask us for help. I ran outside with an EpiPen and immediately noted her pulse of 158 on her watch and she appeared to be experiencing an anaphylactic reaction. Patient stated she did not want to use the EpiPen but wanted to try chewing Benadryl instead first. I asked the staff for a blood pressure monitor and pulse oximeter. The 1st readings, approximately 12 minutes after vaccination, were HR 158, BP 155/105, and pulse ox 97%. Patient stated the Benadryl was working and her swelling was decreasing. The patient was not having trouble breathing at the time. I continued monitoring vitals and talking with the patient and approximately 20 minutes post-vaccination, she was improving (BP down to 134/80 and HR 120) but agreed we should call 911. She decided she wanted to move inside and lie down. I escorted her with support to a bed. Her vitals then increased again to BP 152/95 and HR 133 and her lips and tongue started swelling again. The patient appeared to be more labored in breathing then but still refused the EpiPen. Roughly 5 minutes after lying down, the medics showed up and took over and I went back to the vaccination area. I learned later that the patient refused to go to the hospital and after more observation was eventually allowed to leave with a friend/coworker driving her home.",Not Reported,,Yes,Not Reported,,Not Reported,U,01/14/2021,01/14/2021,0.0,WRK,Metoprolol ER succinate 50mg,,hypertension,,"shellfish, fish, seafood, lisinopril","['Anaphylactic reaction', 'Blood pressure increased', 'Dyspnoea', 'Heart rate increased', 'Lip swelling', 'Paraesthesia', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 948292,IL,57.0,F,Patient was at work on 1/15/21 after having received the vaccine on 1/12/21. She complained of being diaphoretic and her heart rate was 156. She was taken to Hospital. She is being admitted to hospital and has reported that her heart rate is 122 and she has a temperature of 99.4 and elevated lactic acid levels.,Not Reported,,Not Reported,Yes,,Not Reported,N,01/12/2021,01/15/2021,3.0,PVT,unknown,None,None,,NKA,"['Blood lactic acid increased', 'Body temperature increased', 'Hyperhidrosis']",1,MODERNA,IM 948362,MA,53.0,F,Sore arm right away; developed a lump above my left clavicle that was initially the size of half an inch in diameter - round; felt like a cyst. Had our dr check it out. My dr wanted to see me .Found It was lymph node that was activated. No treatment. Very sore; whole region around the lymph node really sore and tender to the touch Had a hard time lifting arm up because it would slide under my clavicle and it really hurt. . Now it is down to the size of a pea. can still feel it but the pain has subsided. My doctor has seen 12 people so far who has had that reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/24/2020,2.0,PVT,Vit D; Zinc; Co-Q 10 and Probiotic,no,arthritis - slight,,Adhesive Tape,"['Injected limb mobility decreased', 'Lymph node pain', 'Lymphadenopathy', 'Pain']",1,MODERNA,SYR 948380,,,F,"1/5/2021 0718 Pt received 2nd COVID vaccine 1/4/21. Oral temp 100.6, near syncope, muscle aches and head aches. Per EMS NSR, denies SOB, and chest pain. 500 ml bolus received in route. In ED, Pt c/o nausea. Pt anxious, sweating and uncomfortable. 0855 Pt resting comfortably, reports decease in pain/body aches 4/10. 1043 Discharge disposition: home. Accompanied By: self. Mode: walk. --Hospital",Not Reported,,Not Reported,Yes,,Not Reported,,01/04/2021,01/05/2021,1.0,PVT,,,,,,"['Anxiety', 'Body temperature increased', 'Discomfort', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Nausea', 'Pain', 'Presyncope']",2,PFIZER\BIONTECH,IM 948418,CO,37.0,F,Expired on 1/12/2021; unknown cause of death,Yes,01/12/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/12/2021,5.0,PVT,Unknown,Received 1st Covid vaccine 12/18/2020; 2nd 1/7/2021. This patient is now deceased 1/12/2021.,"Per patient health history: hearing loss, asthma, bronchiolitis, chronic cough, anemia, depression",,No known,['Death'],UNK,PFIZER\BIONTECH,IM 948428,LA,82.0,F,"We got a call from a home health nurse Brandu Talamo, stating that the patient passed away.",Yes,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,PHM,unknown,unknown,unknown,,unknown,['Death'],1,MODERNA,SYR 948471,WA,50.0,F,"5-6 HOURS AFTER VACCINATION. CONVULSIONS/SEIZURE, HIGH BLOOD PRESSURE, INCREASED HEART RATE,",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PUB,HORMONE REPLACEMENT THERAPY,,NONE,,REGLAN,"['Blood test', 'Computerised tomogram', 'Heart rate increased', 'Hypertension', 'Seizure']",1,MODERNA,SYR 948502,CT,87.0,M,"Severe pain at injection site with some swelling, lethargy, and fever to 101.6 degrees F the day after the injection. He was given acetaminophen, which reduced fever to normal. Low grade fever (99-100 degrees F) two days after vaccine. On the third day after vaccine, on 12/31, he became confused and anxious. Temperature was 104.8 degrees F. He was given acetaminophen and oral hydration overnight. He continued to have a fever to 102 on the following day and was taken to the ED. He was COVID-positive and admitted to the hospital for treatment of COVID-19.",Not Reported,,Not Reported,Yes,10.0,Not Reported,Y,12/28/2020,12/29/2020,1.0,PUB,"Sertraline, Allopurinol, Rivastigmine, Finasteride, Tamsulosin, thiamine, Pravsastatin, Xiidra, melatonin, Preservision, Vitamin D3, fish oil, turmeric, multivitamin",None known,"Depression, hyperlipidemia",,None known,"['Anxiety', 'COVID-19', 'Confusional state', 'Injection site pain', 'Injection site swelling', 'Lethargy', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 949405,PA,66.0,F,"Initially started as shortness of breath followed by fevers, aches, muscle cramps. Ultimately ended up in the hospital with hypoxemia, pleural effusions. Laboratory values showed evidence of acute renal insufficiency, eosinophilia. Physical exam consistent with pulmonary edema and lower extremity macular rash. Entire presentation concerning for DRESS syndrome",Not Reported,,Not Reported,Yes,,Not Reported,N,01/13/2021,01/13/2021,0.0,PVT,"apixaban, aspirin, atorvastatin, carvedilol, esomeprazole, HCTZ, nitrofurantoin",none,"pulmonary embolism, HTN, HL",,PCN - rash,"['Acute kidney injury', 'Blood creatinine increased', 'Dyspnoea', 'Eosinophil count increased', 'Eosinophilia', 'Hypoxia', 'Muscle spasms', 'Pain', 'Pleural effusion', 'Pulmonary oedema', 'Pyrexia', 'Rash', 'Rash macular', 'White blood cell count increased']",1,MODERNA,IM 949474,CA,79.0,M,"Resident had lunch on 01/14/21 and after lunch around 2:00pm, he vomited and stopped breathing. We coded the resident and 911 paramedics came. They pronounced him dead at 2:18pm.",Yes,01/14/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,SEN,Melatonin 3mg PO QHS Amlopidine Besylate 5mg PO QD Atorvastin Calcium 20mg PO QHS Carbidopa-Levodopa 25-100mg PO TID Multiple Vitamin 1 PO QD Senna 8.6mg PO BID Calcium-Vitamin D 600mg PO BID Metformin HCl 500mg PO BID Rivastigmine patch 9,None but he has History of COVID-19 previously when initially admitted to the facility.,"Parkinson's Disease, Diabetes Mellitus Type 2, Hyperlipidemia, Dementia, ASHD, Psychosis, Hypertension, Dysphagia, Acute Sinusitis",,NKA,"['Death', 'Respiratory arrest', 'Vomiting']",1,MODERNA,IM 949487,TX,16.0,F,Patient is 16 years old and pregnant. She received one dose of the Moderna COVID19 vaccine. She has not called the clinic to complain of any side effects. This report is being made because the patient is under the age limit to receive the vaccine at this time.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,OTH,Prenatal vitamins,None,None,,NKA,"['Exposure during pregnancy', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 949523,CA,61.0,F,"Around 00:50am on 01/15/21, C.N.A. reported that the resident looked different and not responding. Initiated Code Blue and started CPR. 911 arrived and pronounced resident dead at 1:01 am.",Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/15/2021,2.0,SEN,Ascorbic Acid Tablet 500 MG GT QD Multi-Vite Liquid (Multiple Vitamins-Minerals) 15 ml GT QD Famotidine Tablet 20 MG GT BID Memantine HCl Tablet 10 MG GT BID Polyethylene Glycol 3350 Kit 7gm GT QD Senna Tablet 8.6 MG (Sennosides) 2 tablets,None,"History of Stroke, Diabetes Mellitus Type 2, Dementia, Dysphagia, Depression, Pressure Injuries Sacral and Left Heel",,NKA,"['Death', 'General physical condition abnormal', 'Resuscitation', 'Unresponsive to stimuli']",1,MODERNA,IM 949555,NY,71.0,M,"Received Pfizer vaccine, first dose on Wed. 01/13/21 between 12 and 1 P.M. Thurs. 01/14/21 in the afternoon he began to note that he had difficultly walking. Went to bed when he woke up at 5:48 A.M. he reported he had ataxia. Patient reported having to walk in tiny steps to stay upright. He went to the emergency room. Had CT scan of head and found blood clots. MRI performed. Stroke found in right PCA territory, but no loss in strength in left lower extremity. Sensation and vision intact. Strength in all four extremities is 5 out of 5.",Not Reported,,Not Reported,Yes,3.0,Yes,N,01/13/2021,01/14/2021,1.0,PVT,"Baby Aspirin, Advil PM , vitamin D, atorvastatin 20 mg",No,"hyperlipidemia. Overweigh, osteoarthritis",,NO,"['Ataxia', 'Cerebral infarction', 'Computerised tomogram head abnormal', 'Computerised tomogram neck', 'Gait disturbance', 'Ischaemic stroke', 'Magnetic resonance imaging brain abnormal', 'Scan with contrast abnormal', 'Thrombosis']",1,PFIZER\BIONTECH,IM 949562,IN,32.0,F,"Tightness in upper chest: Blood Sugar=66 Gave Apple juice and crackers, Blood Sugar=67 5min after juice/crackers; then blood sugar decreased back to 66;",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Blood glucose decreased', 'Chest discomfort']",1,MODERNA,IM 949611,CA,49.0,F,"At 6 days after my second COVID-19 Pfizer vaccine (first dose given 12/17/20), I had acute onset of chest pain and shortness of breath prompting a trip to the Emergency Department. A chest CT Angio to rule out pulmonary embolus was done and negative for pulmonary embolus. My EKG showed some mild ST changes and a troponin I level was elevated at 0.08 (normal 0.04). Subsequent troponin levels 90 minutes apart showed a rising troponin at 0.18 and 0.38. An echocardiogram was performed which showed regional wall motion abnormalities consistent with Takotsubo cardiomyopathy and an ejection fraction of 45%. I was then taken to cardiac catheterization lab for coronary angiograms which were normal. My LV angiogram was consistent with Takotsubo cardiomyopathy and my LVEDP was elevated. I was started on a beta blocker and sent home the following day.",Not Reported,,Yes,Yes,1.0,Not Reported,U,01/06/2021,01/13/2021,7.0,PVT,Ethinol Estradiol Levothyroxine,none,none,,Percocet allergy: hives,"['Arteriogram coronary abnormal', 'Chest pain', 'Computerised tomogram thorax', 'Dyspnoea', 'Echocardiogram abnormal', 'Ejection fraction decreased', 'Electrocardiogram ST segment abnormal', 'Left ventricular end-diastolic pressure increased', 'Stress cardiomyopathy', 'Troponin I increased']",2,PFIZER\BIONTECH,IM 949630,HI,98.0,F,"This patient has been under hospice care for over 2 years at the nursing home. She has had a steady decline with gradual weight loss. She was totally dependent in her care needs. She received the vaccine on 1/2/2021 as part of the facility vaccination campaign. No adverse events noted initially. On 1/3/2021 at 6:06 pm, she was noted on vital sign checks (done every 4 hours for first 72 hours after vaccination) with BP 64/52 but otherwise asymptomatic. Subsequent BP improved. On 1/4/2021 at 4:45 am, pt found with respiratory rate of 30 with otherwise normal vital signs. Tachypnea persisted, so she received liquid morphine 2.5 mg without improvement. Supplemental oxygen was applied. Tachypnea persisted. She had poor oral intake after that point had persistent tachypnea and worsening hypoxemia despite clear lungs on exam. She remained under hospice care and comfort measures were continued. No blood testing or imaging tests were done. She required increasing amounts of oxygen, became hypotensive, and died peacefully on 1/8/2021 at 7:45 pm.",Yes,01/08/2021,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/03/2021,1.0,OTH,"Senna-S, cranberry pills",Redness to left foot about 1 week prior to vaccination that resolved a few days prior,"Advanced Dementia, Seizure disorder, CAD, prior stroke, HTN",,Simvastatin,"['Blood pressure decreased', 'Death', 'Hypophagia', 'Hypotension', 'Hypoxia', 'Oxygen therapy', 'Tachypnoea']",1,MODERNA,IM 949657,DC,89.0,M,"Veteran was found by family slumped over and unresponsive at the breakfast table on 1/13/21, had expired",Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,PVT,"Xarelto ,topical lidocaine patch",,"Atrial fibrillation, Congestive heart failure, Anterior ischemic optic neuropathy of right eye",,none,"['Death', 'Posture abnormal', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 949691,NJ,57.0,M,Anaphylaxis,Not Reported,,Not Reported,Yes,,Not Reported,,01/14/2021,01/14/2021,0.0,UNK,,,,,,['Anaphylactic reaction'],2,PFIZER\BIONTECH,IM 949724,WI,62.0,F,"Pt had 3 vessel CABG on 1/14/21 after presenting to ED with chest pain on 1/9/21. Pt is critically ill following OR after cardiogenic shock, bleeding. Requiring inotropes and Impella.",Not Reported,,Yes,Yes,7.0,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Allopurinol 100mg BID; Adderall XR 30mg 1 capsule po BID is how pt takes--prescribed as 60mg po daily; Adderall 20mg po daily at noon; aspirin EC 81mg po daily; clopidogrel 75mg po daily; Lisinopril 20mg po BID; metoprolol XL 25mg po BID;,"12/1/20 head congestion, double ear aches, post nasal drip. SARS-CoV-2 NAAT test 12/3/20; result not detected.","Hypertensive Heart Disease without heart failure, 2 stents previously placed; hyperlipidemia; ADHD; gout","Tetanus toxoid---arm swelled from shoulder down to hand. Age, date, and brand unknown",morphine -GI nausea and vomiting; tetanus toxoid -arm swelled from shoulder down to hand,"['Cardiogenic shock', 'Chest pain', 'Coronary artery bypass', 'Critical illness', 'Haemorrhage']",2,PFIZER\BIONTECH,IM 949728,MO,52.0,F,vertigo nausea / vomiting diarrhea low-grade fever pain at injection site,Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,Meloxican Paxil Lansaprolozol Lisinopril / HCTZ Atenolol,"Exposed to COVID Saturday, December 19th around 7 p.m.",High Blood Pressure Obesity Anxiety,,Benedryl - Hallucinations,"['Diarrhoea', 'Injection site pain', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test', 'Vertigo', 'Vomiting']",1,MODERNA,SYR 949729,NC,29.0,F,Miscarriage. Expected due date in August 2021. No prior pregnancy history.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,01/01/2021,9.0,PVT,Prenatal vitamins,,bicornuate uterus,,,"['Abortion spontaneous', 'Exposure during pregnancy']",1,PFIZER\BIONTECH,IM 949732,RI,63.0,F,"Bells Palsy 1st injection on 12/20/21 symptoms started 1/7/21, 2nd dose on 1/10/21 immediate numbness in mouth and tightness in throat which triggered bells palsy symptoms immediately",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/20/2020,12/20/2020,0.0,PVT,Premarin .3 mg every other day multi vitamin,none,none,,Compazine side effect anxious,"['Facial paralysis', 'Hypoaesthesia oral', 'Immediate post-injection reaction', 'Throat tightness']",2,PFIZER\BIONTECH,IM 949761,NC,49.0,F,Patient information was reviewed. Patient was asked if they ever had any form of severe reaction to anything they had had in the past. Patient did not state yes to anything other than having a reaction that was managed at home to shellfish as a child. They stated their throat had swollen as a child during the event. Patient was told that it was an anaphylactic reaction and shouldn't have been managed at home as a child by nurse and should have been taken to the hospital. Patient was told they would be monitored for 30 minutes after receiving the vaccine. Within 2-3 minutes after receiving the vaccine the patient reported tingling or burning around the site of injections. Within 5 minutes they stated to be feeling tired and that their arm had felt numb. After this the patient began starring into the distance and was unresponsive. Called for help and advice by turning around as patient had syncoped. Got nurses and other team members attention and had an epi-pen ready just in case it was needed. Patient began having notable distress with respiration and administed an epi-pen. Advised for a nurse to call EMS for patient and crash cart/oxygen was also obtaine dby the facility. Oxygen was required. Patient was not responsive after the first dose and was given a second as they remained un-alert with notable distress. The patient became alert a while after receiving the second shot and not long after that the EMS arrived to the event.,Not Reported,,Not Reported,Yes,,Not Reported,Y,01/15/2021,01/15/2021,0.0,SEN,None reported,None reported,None reported,,Shellfish (Throat Swell Kid) 1/5/21 - Told Anaphylaxis by me,"['Fatigue', 'Hypoaesthesia', 'Injection site pain', 'Injection site paraesthesia', 'Respiratory distress', 'Staring', 'Syncope', 'Unresponsive to stimuli']",1,MODERNA,IM 950174,CA,57.0,F,Bell's Palsy,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/07/2021,2.0,UNK,,,,,,"[""Bell's palsy""]",2,PFIZER\BIONTECH,IM 950175,CA,38.0,F,"2000 - neck pain, headache 2200 - mild body aches 0235 - severe chills, muscle/joint pain, headache. 0600 - fever 102.5F tympanic, took Tylenol 1000 mg + ice packs 0730 - temp 101.9 F; headache severe w/ nausea 0800 - took ibuprofen 600 mg; fatigue, took nap 0930 - temp 100.4 F 1400 - headache continues but much less severe; temp 99.0 F",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,"Rice, Salicylic acid, benzoyl peroxide","['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Neck pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 950176,AK,77.0,M,"Error with diluent, sterile water used",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,,,PVT,"ZITHROMAX, MEVACOR, sodium bicarbonate, NEBULIZER, albuterol-ipratropium, VOLTAREN, NITROSTAT, SYMBICORT, NOVOLIN R, guaiFENesin, ASPIRIN LOW DOSE, PEPCID, DEMADEX, MOVE FREE, IRON, LOPRESSOR, aspirin, VENTOLIN HFA, GARLIC","(L) Knee swelling, steroid use","Cirrhosis, Type 2DM, COPD, CAD, AFiB, CKO, hyperlipidemiA, Ascitic fluid, Anemia, unspecified, Dyspnea, Paroxysmal atrial fibrillation, Cardiac complication, Chronic obstructive pulmonary disease, Coronary artery disease involving native coronary artery without angina pectoris, Essential hypertension, GERD without esophagitis, Sebaceous cyst, Chronic renal insufficiency, Chronic bronchitis, Severe sepsis, Pain and swelling of left knee, Coronary atherosclerosis, Disorder of esophagus, Mixed hyperlipidemia, Chronic atrial fibrillation, COPD (chronic obstructive pulmonary disease),",,NKA,"['Medication error', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 950177,AK,72.0,M,"Error with diluent, sterile water used",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,,,PVT,AMBIEN; SYNTHROID; LIPITOR; TENORMIN; NITROSTAT; FLONASE; LIDODERM; FLOMAX; VENTOLIN HFA; Vitamin C; B Complex Vitamins; PRILOSEC; aspirin; Vitamin B 12; Vitamin D,,,,,['Product preparation error'],1,PFIZER\BIONTECH,IM 950178,AK,73.0,M,"Error with diluent, sterile water used",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,,,PVT,lisinopril; albuterol; aspirin; LIPITOR; GLUCOPHAGE,0,"Hyperlipidemia, Presence of aortocoronary bypass graft, Prediabetes, Gout, Mitral valve regurgitation, Allergic rhinitis due to pollen, CAD (coronary artery disease), Thyroid nodule, Recurrent nephrolithiasis, Sarcoidosis",,NKA,['Product preparation error'],1,PFIZER\BIONTECH,IM 950179,AK,93.0,F,"Error with diluent, sterile water used",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,,,PVT,PEPCID; SENOKOT; CELEXA; MIRALAX; COLACE; METAMUCIL; Vitamin B12; CULTURELLE; BENTYL; FLONASE; DITROPAN-XL; PROAIR RESPICLICK; COZAAR; YUVAFEM; VOLTAREN; ELOCON; Vitamin D-3; FLOVENT HFA; MICROZIDE; XALATAN; levothyroxine; MYRBETRIQ,,"COPD; Atrophic Vaginitis, Postmenopausal; B 12 deficiency; Benign Essential Hypertension; Colon polyps; Coronary artery disease; Dysphagia; Glaucoma; Hypothyroidism, Acquired; Lichen planus; DJD; spinal stenosis; osteoarthrosis of the spine; Lumbosacral radiculopathy; Periodic limb movement disorder; Sleep disturbances, other; Urinary incontinence; Varicose veins of lower extremities with pain; Vasculitis; Lichen sclerosus; Vaginal atrophy; Left anterior knee pain; Difficulty walking; Activity moderately limited; Low back pain; Weakness of back; Glaucoma; Patellar tendinitis of right knee; Coronary atherosclerosis; other constipation; Abdominal pain, chronic, left lower quadrant; Gastroesophageal reflux disease without esophagitis; Otitis externa; Mixed stress and urge urinary incontinence; Hypercalcemia",,Sulfa antibiotics; Fesoterodine; Erythromycin; Fesoterodine Fumarate Er; Ibuprofen; Naproxen; Pantoprazole,['Product preparation error'],UNK,PFIZER\BIONTECH,IM 950180,AK,,F,"Error with diluent, sterile water used",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,,,PVT,ZESTORETIC; ZOCOR; OCUVITE; Multiple Vitamins-Minerals; ZALATAN; aspirin; XABAX; VITAMIN C; OSCAL; Lysine,,Allergic rhinitis; GERD; Hyperglycemia; Hyperlipidemia; Hypertension; Osteopenia; Insomnia,,Milk; Pollen Extract,['Product preparation error'],1,PFIZER\BIONTECH,IM 950183,AK,82.0,F,"Error with diluent, sterile water used",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,,,PVT,"SYNTHROID, hydroCHLOROthiazide, TOPROL XL, PRINIVIL/ZESTRIL, LIPITOR, VENTOLIN HFA 108, FLOVENT HFA, COUMADIN, OCEAN NASAL SPRAY, FLONASE, NITROSTAT",0,"Anticoagulated, Atrial Fibrillation, Chronic pain, Colon polyps, CVA, Health care maintenance, Hyperglycemia, Hyperlipidemia, Hypertension, Papillary thyroid carcinoma, Reactive airway disease, Gross hematuria, Microhematuria, Hypothyroidism",,"Amoxicillin-pot Clavulanate, Nausea And Vomiting, Cephalosporins, Diarrhea, Clavulanic Acid (from Augmentin) GI upset, Diarrhea, Trimethoprim, Diarrhea","['Medication error', 'Product preparation issue']",1,PFIZER\BIONTECH,IM 950185,AK,74.0,F,"Error with diluent, sterile water used",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,,,PVT,NORVASC; COZAAR; ZOFRAN; NORCO; ESTRADIOL TD;,Congestion of sinus (nasal),"Hypertension; Cancer of right kidney parenchyma (HCC); Solitary kidney, acquired; Atrophic vaginitis; Gastroesophageal reflux disease; Hyperlipidemia; Lichen sclerosus et atrophicus; Renal cyst",,Sulfa Antibiotics; Codeine; Sulfites (sulfites in food),['Product preparation error'],1,PFIZER\BIONTECH,IM 950186,AK,68.0,M,"Error with diluent, sterile water used",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,,,PVT,lisinopril; LIPITOR; aspirin; CALCIUM-MAGNESIUM-ZINC; LASIX; ALDACTONE; FLOMAX;,0,Obstructive sleep apnea; Malignant melanoma of left shoulder (HCC); Hypertension; Hyperlipidemia; Lower extremity edema; Malignant neoplasm of skin; PSA elevation; Inguinal hernia repair; Umbilical hernia repair,,NKA,['Product preparation error'],1,PFIZER\BIONTECH,IM 950187,AK,71.0,M,"Error with diluent, sterile water used",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,,,PVT,IMDUR; LIPITOR; GLUCOPHAGE; lisinopril; SINEMET; HUMULIN R U-500 KWIKPEN; PROSCAR; fish oil; Glucosamine-Chondroitin; Vitamin C; TOPROL-XL; MYCOSTATIN; NORVASC; aspirin,0,"Aortic root enlargement; COPD; Diabetes mellitus, type II; Hematuria; Hyperlipidemia; Hypertension; Memory change; Obesity; Obstructive sleep apnea; Onychomycosis; Parkinson disease; High altitude periodic breathing; Enlarged and hypertrophic nails; Personal history of nicotine dependence; Long term (current) use of insulin (HCC); Long term (current) use of aspirin; Allergy status to sulfonamides status; Tinea unguium; Onychogryphosis; Corns and callosities; Nocturia; Family history of prostate cancer; Special screening for malignant neoplasms, colon; Abnormal urine cytology; Gross hematuria; Colon polyp; Acquired complex cyst of kidney; ED (erectile dysfunction); Rectal polyp; Angina at rest (HCC)",,Sulfa,['Product preparation error'],1,PFIZER\BIONTECH,IM 950188,AK,69.0,M,"Error with diluent, sterile water used",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,,,UNK,See supporting documents,0,None Listed,,none on file,['Product preparation error'],1,PFIZER\BIONTECH,IM 967751,,83.0,M,injection site pain Narrative:,Not Reported,,Not Reported,Yes,,Not Reported,U,01/11/2021,01/12/2021,1.0,OTH,,,,,,['Injection site pain'],UNK,MODERNA,IM 967752,,79.0,M,Narrative:,Not Reported,,Not Reported,Yes,,Not Reported,N,01/08/2021,01/09/2021,1.0,OTH,,,,,,"['Chest X-ray normal', 'Pyrexia', 'Urine analysis normal', 'White blood cell count normal']",1,MODERNA,IM 949826,CA,85.0,F,"Resident reported loose stool, not feeling well, resident complaint of lost taste. Hospitalization on 01/14/2020.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/12/2021,01/12/2021,0.0,SEN,,,,,,"['Ageusia', 'Diarrhoea', 'Malaise']",1,PFIZER\BIONTECH,IM 949835,CA,69.0,F,Vomiting,Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/12/2021,01/13/2021,1.0,UNK,,,,,,['Vomiting'],1,PFIZER\BIONTECH,IM 949941,NY,55.0,F,"Per husband, was in usual state of health on the AM of 1/10/20, AOx3 able to perform all I/ADLs. At around 2:30pm that day was complaining of chills and generalized malaise. Then at ~9:30pm when husband returned home from work found patient diaphoretic, confused (stating things like ""not now, I want to go to lake""), and complaining of chills and weakness. Unable to provide any additional hx regarding other sx. Initially presented to ED, where mental status had deteriorated to AOx0, unable to respond to verbal commands. Initial vitals notable for T102.6F (unclear other vitals). Patient is now AOx0 most concerning for encephalopathy.",Not Reported,,Yes,Yes,,Not Reported,N,12/28/2020,01/10/2021,13.0,PVT,,,,,,"['Anti-NMDA antibody negative', 'Asthenia', 'Body temperature increased', 'CSF cell count increased', 'CSF culture negative', 'CSF glucose normal', 'CSF lactate dehydrogenase normal', 'CSF lymphocyte count abnormal', 'CSF neutrophil count increased', 'CSF protein increased', 'CSF red blood cell count positive', 'CSF test normal', 'Chills', 'Confusional state', 'Cryptococcus test', 'Gram stain negative', 'Herpes simplex test negative', 'Hyperhidrosis', 'Malaise', 'Mental impairment', 'Polymerase chain reaction', 'Treponema test negative', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 949965,,101.0,F,"Patient 101 years old, nursing home resident, received vaccine 1/11, on 1/13 found on floor without obvious trauma, unresponsive. Brought to ED and was bradycardic, hypotensive, hypothermic and refractory to aggressive medical management. No obvious cause of death found on exam or labs, cxr. Unknown if event could be related to vaccine or not. Medical Examiner accepted case although initially unknown that patient had recently received vaccine. ME updated with that information today as soon as discovered.",Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/13/2021,2.0,SEN,,,,,,"['Blood culture negative', 'Bradycardia', 'Chest X-ray normal', 'Culture urine negative', 'Death', 'Hypotension', 'Hypothermia', 'Laboratory test normal', 'Respiratory viral panel', 'Unresponsive to stimuli', 'Viral test', 'Viral test negative']",UNK,PFIZER\BIONTECH, 949967,CA,68.0,F,"Throbbing head ache, difficulty breathing, lips numbness, chest discomfort, upper back, lower legs, fingers tingling/numbness, high blood pressure 148/83, underarm sweating, feels weak",Not Reported,,Yes,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,aller-tec --allergy over the counter medication,none,none,,"nitorfurantoin, Peniccilin class, septra, sulfa","['Asthenia', 'Blood pressure increased', 'Chest X-ray', 'Chest discomfort', 'Dyspnoea', 'Electrocardiogram', 'Headache', 'Hyperhidrosis', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Influenza virus test', 'Paraesthesia', 'Polymerase chain reaction', 'SARS-CoV-2 test']",1,MODERNA,IM 950021,IN,64.0,M,"Nausea with emesis, headache, upper abdominal pain.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/02/2021,01/04/2021,2.0,SEN,Miralax 17gm daily Eliquis 5mg BID Amitriptyline 10mg at HS Bupropion 100mg TID Lexapro 10mg daily Fentanyl 50mcg patch every 3 days Amplodipine 5mg daily Atorvastatin 20mg at HS Baclofen 5mg QID Docusate Sodium 100mg BID Gabapentin 400mg 2,,"HEMIPLEGIA AND HEMIPARESIS FOLLOWING CEREBRAL INFARCTION AFFECTING LEFT NON-DOMINANT SIDE CEREBRAL INFARCTION DUE TO THROMBOSIS OF RIGHT POSTERIOR CEREBRAL HEMIPLEGIA AND HEMIPARESIS FOLLOWING CEREBRAL INFARCTION AFFECTING LEFT NON-DOMINANT SIDE OTHER IRON DEFICIENCY ANEMIAS TYPE 2 DIABETES MELLITUS WITH DIABETIC CHRONIC KIDNEY DISEASE DYSPHAGIA FOLLOWING CEREBRAL INFARCTION HYPOKALEMIA MIXED HYPERLIPIDEMIA POLYNEUROPATHY, UNSPECIFIED ESSENTIAL (PRIMARY) HYPERTENSION UNSPECIFIED ATRIAL FIBRILLATION GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS RESTLESS LEGS SYNDROME ALLERGIC RHINITIS, UNSPECIFIED ANXIETY DISORDER, UNSPECIFIED ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITH UNSPECIFIED ANGINA PECTORIS CHRONIC PAIN SYNDROME CHRONIC TENSION-TYPE HEADACHE, INTRACTABLE ESSENTIAL (PRIMARY) HYPERTENSION INSOMNIA, UNSPECIFIED LONG TERM (CURRENT) USE OF ANTICOAGULANTS MAJOR DEPRESSIVE DISORDER, RECURRENT, UNSPECIFIED MUSCLE WEAKNESS (GENERALIZED) OTHER MUSCLE SPASM PERSONAL HISTORY OF COVID-19 UNSPECIFIED ATRIAL FIBRILLATION VASCULAR DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE LOCAL INFECTION OF THE SKIN AND SUBCUTANEOUS TISSUE, UNSPECIFIED OTHER CONSTIPATION",,Tape allergy,"['Abdominal pain upper', 'Amylase', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram pelvis', 'Differential white blood cell count', 'Full blood count', 'Headache', 'Hepatic enzyme increased', 'Hyperbilirubinaemia', 'Lipase', 'Liver function test increased', 'Metabolic function test', 'Nausea', 'Nephrolithiasis', 'Pancreatitis acute', 'Renal cyst', 'Scan with contrast abnormal', 'Vomiting']",1,MODERNA,IM 950057,AL,49.0,F,"Patient suffered a cardiac arrest and was unable to give details about her symptoms. Per husband, patient did not complain of any symptoms after vaccine administration. She began seizing without warning which was complicated by cardiac arrest of uncertain etiology",Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,PVT,,,Hydrocephalus with ventricular shunting Prior history of leukemia,,,"['Cardiac arrest', 'Seizure']",UNK,MODERNA,IM 950066,NE,65.0,M,Right arm weakness 2 hrs after vaccine and then right leg weakness later that evening,Not Reported,,Not Reported,Yes,3.0,Yes,N,01/07/2021,01/07/2021,0.0,SEN,"Aspirin, Lipitor,Zyrtec, Klonopin, cranberry tab, mucinex, famotidine, Flonase, Lactase, lactobacillus, synthroid, mirtazapine, nitrofurantoin, fish oil, pro tonic, potassium, propranolol, carafate, trazodone",none,"Cerebral palsy, history of ischemic CVA, anxiety, GERD, Hyperlipidemia, hypertension, hypothyroidism",,"Haldol, risperidone, thioridazine, lactose, lorazepam, olanzapine","['Computerised tomogram head abnormal', 'Hemiparesis']",1,MODERNA,IM 950073,WI,63.0,M,"On 1/15/2021 at 1800, resident noted to be lethargic and shaking, stating ""I don't care."" repeatedly. C/O head and neck pain. T100.6. Given Tylenol with no relief of pain. Order received for Aleve and administered.. Assisted to bed as usual in evening. Monitored during night shift and noted to be resting comfortably/sleeping.. Noted agonal breathing at 4:10 AM 1/16/2021 , T 99.4, Absence of vital signs at 4:15AM 1/16/21 and death pronounced at 4:40AM 1/16/21.",Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,SEN,"Amlodipine, Aspirin, Atenolol, Chlorthalidone, Dexamethasone, Fluconazole, Multivitamin with Minerals, Probiotic, Acyclovir, Topiramate, Cefpodoxime, levetiracetam, Potassium, Acetaminophen, Aleve, Lisinopril","Non-Hodgkin Lymphoma, Rhabdomyolysis, Anemia, Acute Kidney Failure, Chronic Embolism and Thrombosis of Lower Extremity","Epilepsy, Hypertension, Atrial Fibrillation, Anxiety",,"Lisinopril, Losartan","['Body temperature increased', 'Death', 'Headache', 'Lethargy', 'Mycobacterium tuberculosis complex test negative', 'Neck pain', 'Respiration abnormal', 'Tremor', 'Vital functions abnormal']",1,MODERNA,IM 950108,KY,53.0,F,"""Moderna COVID-19 Vaccine EUA"" It has been reported to me that pt. had gone into hospital for a heart catheterization on 1/12/2021. It was found during this procedure that pt. had suffered a MI. She was release to home the following day and passed away at her residence on 1/15/2021.",Yes,01/15/2021,Not Reported,Yes,1.0,Not Reported,N,01/05/2021,01/12/2021,7.0,PUB,Unknown,Pt. stated she was not ill at the time of vaccination.,Unknown,,Unknown,"['Catheterisation cardiac abnormal', 'Death', 'Myocardial infarction']",1,MODERNA,IM 950111,HI,59.0,F,"anaphalactic shock reaction, epi injection by hospital emergency staff at vaccine site, emergency room admission . We were very lucky vaccine site was Hospital was concerned that this might happen as patient had a previous anaphalactic shock by antibiotic injection few years ago",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,OTH,none,none,,,"yes, rosefin",['Anaphylactic shock'],1,PFIZER\BIONTECH,SYR 950118,TN,38.0,M,"Right thumb joint pain. I can't hold unto things in my right hand that requires me using pressure from my thumb. Pain is a 9/10 when holding, grabbing, or using the thumb in any way. When not using the thumb there is no pain at all. I work out everyday and I am no longer to lift weights using my right hand because of the excruciating pain when I try to.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/07/2021,01/09/2021,2.0,PVT,,,,,,"['Arthralgia', 'Loss of personal independence in daily activities', 'Motor dysfunction', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 950132,NY,58.0,M,"Patient had COVID-19 infection April 2020, ataxia and myoclonus developed, treated with IVIG and steroids at that time. June 2020 had full recovery after PT. Pt received Pfizer COVID-19 dose 1 on 12/22/20 and developed similar symptoms to above on 1/7/2021. Ataxia and tremor on examination, no myoclonus at this time.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/22/2020,01/07/2021,16.0,PVT,"Jardiance, Metformin, Simvastatin, Ramapril, Amlodipine Vitamin D, Vitamin E, Fish Oil, Tumeric",None,"HTN, DM, HLD",,None,"['Ataxia', 'Tremor']",1,PFIZER\BIONTECH,IM 950255,CO,32.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,,,,,,['Unevaluable event'],2,PFIZER\BIONTECH,IM 950387,VA,39.0,F,Swollen tongue and sob with decreased swallow,Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/14/2021,01/15/2021,1.0,PVT,"Pamalor, bentl, motrin, wellbutrin, iron, vit. D",Bronchitis,"Ptsd, mst, chronic back pain, pcos, endometriosis,",,"Dilaudid, prednisone","['Blood test', 'Dysphagia', 'Dyspnoea', 'Swollen tongue']",2,PFIZER\BIONTECH,IM 950406,NY,31.0,F,"Redness, pain, warmth, burning at injection site and pain in left arm starting 11 days after receiving vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/15/2021,10.0,UNK,Prenatal vitamin,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site warmth']",1,MODERNA,IM 950414,NV,27.0,F,"Vaccinated at 8:55am, Per Nurse Practitioner note patient started experiencing itching upper chest, medicated with Benadryl P.O., started with throat itching, medicated with Benadryl IM, EPI IM, EMS called, placed on O2, diminished breath sounds bases, slight stridor, EPI IM, Solumedrol IM, EMS transported to local ED. Patient called NP later in day and said she was admitted to the hospital.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/15/2021,01/15/2021,0.0,OTH,,,,,,"['Breath sounds abnormal', 'Pruritus', 'Stridor', 'Throat irritation']",1,PFIZER\BIONTECH,IM 950441,CA,66.0,M,"Pt had witnessed arrest by wife. Pt wife started CPR and called EMS. CPR started at 15:12. Continued by EMS. Pt arrived to medical center asystole with CRP in progress and ventilated via igel device. He was in refractory ventricular fibrillation and continued CPR for a total of 1 hour. At that point, we checked a bedside ultrasound which showed his heart at a standstill. He was unresponsive to verbal and tactile stimulus and had fixed unreactive pupils. He was pronounced at 16:13.",Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,PVT,Hydrochlorothiazide Toprol XL spironolactone prasugrel furosemide Vit D3 albuterol inhaler sildenafil aspirin 81mg Crestor nitroglycerin SL singulair testosterone gel levothyroxine,Chronic systolic heart failure Coronary artery disease involving native coronary artery of native heart without angina pectoris,Chronic systolic heart failure Coronary artery disease involving native coronary artery of native heart without angina pectoris lower extremity edema,,Walnuts,"['Adjusted calcium', 'Alanine aminotransferase increased', 'Albumin globulin ratio', 'Anion gap', 'Aspartate aminotransferase increased', 'Band neutrophil percentage decreased', 'Basophil count normal', 'Basophil percentage', 'Blood albumin normal', 'Blood alkaline phosphatase increased', 'Blood bilirubin normal', 'Blood calcium normal', 'Blood chloride decreased', 'Blood creatinine normal', 'Blood glucose normal', 'Blood magnesium increased', 'Blood potassium decreased', 'Blood sodium decreased', 'Blood urea nitrogen/creatinine ratio', 'Blood urea normal', 'Carbon dioxide normal', 'Cardiac arrest', 'Death', 'Differential white blood cell count abnormal', 'Echocardiogram abnormal', 'Eosinophil count normal', 'Eosinophil percentage', 'Full blood count abnormal', 'Globulin', 'Glomerular filtration rate', 'Haematocrit normal', 'Haemoglobin normal', 'Immature granulocyte percentage increased', 'Lymphocyte count normal', 'Lymphocyte percentage increased', 'Mean cell haemoglobin concentration decreased', 'Mean cell haemoglobin normal', 'Mean cell volume increased', 'Mean platelet volume increased', 'Mechanical ventilation', 'Metabolic function test abnormal', 'Monocyte count normal', 'Monocyte percentage', 'Neutrophil count normal', 'Neutrophil percentage decreased', 'Neutrophil toxic granulation present', 'Platelet count normal', 'Protein total normal', 'Pupil fixed', 'Red blood cell count normal', 'Red blood cell nucleated morphology present', 'Red cell distribution width normal', 'Resuscitation', 'Unresponsive to stimuli', 'Ventricular fibrillation', 'White blood cell count normal']",1,PFIZER\BIONTECH,IM 950482,IA,93.0,F,"ADVERSE REACTION REPORTED AS TEMPERATURE OF 100.0, CONFUSION, AND VERTIGO. PATIENT WAS TAKEN TO HOSPITAL, UNAWARE OF CURRENT STATUS, TREATMENTS, OR OUTCOME.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/15/2021,01/16/2021,1.0,SEN,,,,,,"['Body temperature increased', 'Confusional state', 'Vertigo']",1,PFIZER\BIONTECH,IM 950562,GA,36.0,F,"9 days after vaccine, I had a miscarriage. I was 5 weeks pregnant at that time. I had confirmation lab test 2 weeks prior of pregnancy and had labs with bhcg lower at time of bleeding to confirm miscarriage",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,None,None,Migraines Eczema Seasonal allergies,,"Sulfa, eggs","['Abortion spontaneous', 'Exposure during pregnancy', 'Haemorrhage', 'Human chorionic gonadotropin negative']",1,PFIZER\BIONTECH,IM 950571,HI,32.0,F,"Pregnancy history: early pregnancy, 5 weeks. Symptoms included pain at injection site, mild muscle aches, and fatigue. Symptoms starting about 12 hours after shot. 500mg tylenol taken twice.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/12/2021,1.0,WRK,"latuda, fish oil, prenatal vitamin, calcium",not applicable,depression,,no known allergies,"['Fatigue', 'Injection site pain', 'Myalgia', 'Pregnancy']",2,PFIZER\BIONTECH,IM 950611,PA,47.0,F,"After vaccination on 1.8.21 felt fatigue, metallic taste, and intermittent tingling. on 1.15.21 at approximately 8 am developed occipital headache (4/10 pain) inability to move right upper or lower extremities and slurred speech. No evidence of intracranial hemorrhage on CT. Patient administered Alteplase and transferred to higher level of care",Not Reported,,Not Reported,Yes,,Not Reported,U,01/08/2021,01/15/2021,7.0,PVT,Duoneb Metformin Tricor Synthroid Zocor,,Hypertension Hypothyroidism Pansinusitis Hypercholesterolemi Diabetes,,none,"['Blood gases', 'Brain natriuretic peptide', 'Computerised tomogram head normal', 'Differential white blood cell count', 'Dysarthria', 'Dysgeusia', 'Electrocardiogram', 'Fatigue', 'Full blood count', 'Headache', 'Mobility decreased', 'Occult blood', 'Paraesthesia', 'Prothrombin time', 'SARS-CoV-2 test']",1,MODERNA,IM 950640,AL,34.0,F,"Day 1-3 after the dose flu like symptoms Day 3-7 swelling in lymph nodes on left side of body (baseball sized) took ibuprofen and Tylenol Day 8 angioedema, anaphylaxis. Received epi subq, IVP 50mg Benadryl, Pepcid 20mg IVP, liter of NS Day 9 raised red rash all over body and face still going on Day 16- present: severe joint pain and fever, unable to obtain any relief",Not Reported,,Yes,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,"Ambien, metformin, spironolactone, zyrtec, adderall, birth control",Upper respiratory infection 2 weeks prior,"Polycystic ovarian syndrome, fatty liver",,Stadol,"['Anaphylactic reaction', 'Angioedema', 'Arthralgia', 'Blood thyroid stimulating hormone normal', 'Chest X-ray normal', 'Full blood count normal', 'Influenza like illness', 'Influenza virus test negative', 'Lymphadenopathy', 'Metabolic function test normal', 'Pyrexia', 'Rash', 'Rash erythematous', 'Rash papular', 'SARS-CoV-2 test negative', 'Streptococcus test negative']",1,MODERNA,IM 950666,NY,41.0,U,"Cough, dizzy, chest pain, bone pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/11/2021,01/11/2021,0.0,UNK,None,None,None,,None,"['Bone pain', 'Chest pain', 'Cough', 'Dizziness', 'Electrocardiogram']",1,PFIZER\BIONTECH,IM 950743,NY,49.0,M,Muscle Spas; Weakness in both limbs. Pressured speech,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/28/2020,01/10/2021,13.0,PVT,None,None,Gout,,None,"['Blood test', 'Computerised tomogram', 'Electroencephalogram', 'Magnetic resonance imaging', 'Muscle spasms', 'Muscular weakness', 'Pressure of speech']",1,PFIZER\BIONTECH,IM 950759,IL,63.0,F,"Pounding headache, heart racing to over 145 bps, chest burning and tightness and hard to breath. I was taken to the Emergency Room at Hospital immediately. Reaction occurred within 30 minutes of the injection. An EKG was administered. I was prescribed prednisone and Benadryl. I was diagnosed with Anaphylaxis.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Vitamin C and D,None,None,"Flu vaccine in 2015, shortness of breath, heart racing, tightness in chest, congestion.","Flu Vaccine, penicillin and sulfur","['Anaphylactic reaction', 'Chest discomfort', 'Chest pain', 'Dyspnoea', 'Electrocardiogram', 'Headache', 'Palpitations']",2,PFIZER\BIONTECH,SYR 950787,FL,73.0,M,Patient had slow progression of kidney disease but since vaccine had unexpected acute kidney failure. He had to have dialysis and may need biopsy of kidney to confirm if he needs lifelong dialysis. He is still being hospitalized.,Not Reported,,Yes,Yes,,Not Reported,N,01/09/2021,01/14/2021,5.0,PUB,"Lantus, Humalog, metoprolol, lisinopril, pioglitazone, gabapentin, nifedipine, escitalopram, aspirin, bydureon, vitamin B, vitamin D, clopedigril, metformin, atorvastatin","High BP, diabetes, stage 3 kidney disease","Diabetes, past stroke, kidney disease, circulation issues, orthostatic hypotension, high blood pressure, depression.",,,"['Acute kidney injury', 'Condition aggravated', 'Dialysis']",1,MODERNA, 950840,CA,44.0,F,"Numbness and tingling sensations in both hands and sometimes radiating up my forearms, more severe in right hand and right thumb; these symptoms still didn?t go away since 1/11",Not Reported,,Not Reported,Not Reported,,Yes,N,01/05/2021,01/11/2021,6.0,PVT,"Viorele, Fish Oil, Vitamin D, Prenatal vitamins",None,None,,No known allergies,"['Blood thyroid stimulating hormone normal', 'Differential white blood cell count normal', 'Full blood count normal', 'Glycosylated haemoglobin normal', 'Hypoaesthesia', 'Laboratory test normal', 'Liver function test normal', 'Paraesthesia', 'Treponema test negative', 'Vitamin B12 normal']",1,PFIZER\BIONTECH,IM 950893,PA,90.0,F,Death,Yes,01/07/2021,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/07/2021,4.0,SEN,"Ask the nursing home,","Diabetes dementia, cll, trigeminal neuralgia",Diabetes dementia cll trigeminal neuralgia,,"Shellfish, other",['Death'],UNK,PFIZER\BIONTECH, 950911,CA,41.0,M,After 2nd dose in the afternoon at 2:30pm pt collapse in the unit V/S was high blood sugar was high. Pt was held over at work for 16 hours. Shot was given at 6:45am. Paramedics was called. Sent to ER.,Not Reported,,Not Reported,Yes,1.0,Not Reported,,01/15/2021,01/15/2021,0.0,UNK,"Alloporinol, Multivitamin, Osteo Biflex",,,,,"['Blood glucose increased', 'Syncope']",2,PFIZER\BIONTECH,IM 951232,CA,60.0,M,"Severe Nausea experienced 8 hours after the IM injection Treated with Zofran, Omeprazole, Diphenhydramine and Pepto-Bismol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,Losartan,,Hypertension,,Compazine,['Nausea'],1,PFIZER\BIONTECH,IM 951317,,33.0,F,"Headache, Myalgia, NauseaVomiting, Tachycardia, Fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/14/2021,2.0,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Tachycardia', 'Vomiting']",2,PFIZER\BIONTECH,IM 951318,,57.0,M,"Myalgia fatigue, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/07/2021,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Myalgia']",1,PFIZER\BIONTECH,IM 951319,,,F,"neuraliga starting 12 hrs p 2nd dose, durating 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/20/2021,11.0,OTH,,,,,,['Neuralgia'],2,PFIZER\BIONTECH,IM 951320,,44.0,F,"Myalgia, Fever, NauseaVomiting, fatigue Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,01/13/2021,,OTH,,,,,,"['Fatigue', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 951321,,67.0,F,"Headache, Myalgia, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,01/13/2021,,OTH,,,,,,"['Fatigue', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH,IM 951322,,49.0,F,"Headache, Myalgia, Fever, Fatigue Narrative: missed work 1/14/21",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,01/14/2021,,OTH,,,,,,"['Fatigue', 'Headache', 'Impaired work ability', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 951323,,44.0,F,"Headache, Myalgia, Fever, NauseaVomiting, fatigue, sore arm Narrative: missed work 1/8/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,01/08/2021,,OTH,,,,,,"['Fatigue', 'Headache', 'Impaired work ability', 'Myalgia', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH, 967744,,53.0,M,diagnosed with Covid-19 2 days after receiving the vaccine although retrospectively he noted that symptoms started 1-2 prior to vaccine Narrative: still on oxygen at this time. Unknown if this will be permanent,Not Reported,,Not Reported,Yes,4.0,Not Reported,N,12/24/2020,12/26/2020,2.0,OTH,,,,,,['COVID-19'],1,MODERNA,IM 967745,,54.0,M,AcuteTubularNecrosis Narrative: Was hospitalized on 1/13/21 and discharged on 1/15/21. Given IV fluids.,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,12/24/2020,01/13/2021,20.0,OTH,,,,,,['Renal tubular necrosis'],1,PFIZER\BIONTECH,IM 967746,,97.0,M,Narrative:,Not Reported,,Not Reported,Yes,,Not Reported,U,01/12/2021,01/13/2021,1.0,OTH,,,,,,"['Blood chloride increased', 'Blood creatinine normal', 'Blood glucose increased', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea increased', 'Brain natriuretic peptide increased', 'Carbon dioxide normal', 'Glomerular filtration rate', 'Haematocrit decreased', 'Haemoglobin decreased', 'Platelet count normal', 'Red blood cell count decreased', 'Troponin increased', 'White blood cell count increased']",1,MODERNA,IM 967747,,73.0,M,Pt passed away evening of 1/13 - unknown reason currently Narrative:,Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/13/2021,0.0,OTH,,,,,,['Death'],1,MODERNA,IM 967748,,83.0,M,Narrative:,Not Reported,,Not Reported,Yes,,Not Reported,U,01/13/2021,,,OTH,,,,,,['Unevaluable event'],UNK,PFIZER\BIONTECH, 967749,,83.0,M,Cardiac Arrest Narrative:,Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,OTH,,,,,,"['Brain natriuretic peptide increased', 'Cardiac arrest', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,IM 967750,,73.0,F,Facial numbness Narrative:,Not Reported,,Not Reported,Yes,,Not Reported,U,01/08/2021,01/09/2021,1.0,OTH,,,,,,"['Angiogram cerebral normal', 'Arteriogram carotid normal', 'Hypoaesthesia', 'Magnetic resonance imaging brain normal']",1,PFIZER\BIONTECH,IM 950926,FL,72.0,M,"Remarkable Myalgia of extremities and back, interfering with rolling or sitting. Spasmodic twitching of upper extremities, These resulted in Hospitalization.",Not Reported,,Not Reported,Yes,2.0,Yes,Y,12/30/2020,01/07/2021,8.0,PVT,"Simvastatin, Buproprion, Propranalol(low dose 10mg bid), ASA 81mg, Gabapentin 600mg, Solifenacin 5m bid, D-amphetanine, Vit D3, Advanced Memory Formula. Nurtec one tablet 01/07/2021 11am for Migraine (first time used.)","None. ""Migraine"" on morning of 01/07/2020.(Scintillated Scotoma) 1x","Mild,Asthmatic Bronchitis.",,None.,"['Angiogram', 'Chest X-ray', 'Computerised tomogram thorax', 'Echocardiogram', 'Electrocardiogram', 'Electroencephalogram', 'Magnetic resonance imaging brain', 'Muscle twitching', 'Myalgia']",1,MODERNA,IM 950935,CA,,F,Resident expired,Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,,01/12/2021,01/15/2021,3.0,UNK,,,,,,['Death'],1,PFIZER\BIONTECH,IM 950966,,34.0,M,On 1/9/2021 started to have Postural Orthostatic Tachycardia Syndrome and PVCs associated with SOB and chest tightness and not recovered yet.,Not Reported,,Not Reported,Yes,,Not Reported,N,12/22/2020,01/09/2021,18.0,UNK,,,,,,"['Cardiac telemetry abnormal', 'Chest discomfort', 'Dyspnoea', 'Postural orthostatic tachycardia syndrome', 'SARS-CoV-2 test negative', 'Ventricular extrasystoles']",1,PFIZER\BIONTECH,IM 950979,MI,81.0,M,Headache after dose was given at 10:00 a.m Died at after 7:30 pm the same night the dose was given.,Yes,01/14/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,PUB,allopurinol -Zyoprim 3000 mg amlodipine Norvasc 5 mg Lispro 100/unit /ml ups us to 150 unit daily per insulin scale Levemir U-100 - 100/unit/ml - (3ML) 55 units nightly Levothryoxine -Synthroid - 137 mcg - daily Simvastatin 25 mg - d,,IPF - Idoipathic Pulmonary Fibrosis Diabetic,,Lisinopril,"['Death', 'Headache']",1,MODERNA,SYR 950980,FL,50.0,F,"On January 14, 2021, I noticed generalized petechiae all over my body. I went to seek medical care and was found to have platelet count of 2. I was hospitalized for idiopathic thrombocytopenic purapura. I was given platelets which increased my platelets to 4. Next day, given IVIG dose. Also receiving 4 doses of decadron. Day after IVIG, platelets to 20. I am still in the hospital getting treatment today.",Not Reported,,Yes,Yes,4.0,Not Reported,N,12/22/2020,01/14/2021,23.0,WRK,Lopressor 50 mg PO daily,None,High blood pressure.,,NKA,"['Computerised tomogram head normal', 'HIV test negative', 'Hepatitis B test negative', 'Hepatitis C test negative', 'Immune thrombocytopenia', 'Immunoglobulin therapy', 'Petechiae', 'Platelet count decreased', 'Platelet transfusion', 'SARS-CoV-2 test negative']",1,MODERNA,IM 951043,CT,38.0,M,"Moderna COVID-19 Vaccine EUA. Patient has tested positive for Covid 19 as of 1/10/2021, when he was hospitalized. Patient's wife had been rushed to the ER previously, and they discovered she was Covid positive when she was admitted. Patient immediately notified public health and was being restricted and followed up with. During his quarantine, he started developing symptoms (08Jan2021). On 10 Jan, he was rushed to the ER and diagnosed with pneumonia due to Covid. He was also experiencing painful stomach cramps, low oxygen saturations and fluctuations in blood pressure. He spent 3 days inpatient in the Covid wing then was discharged to resume resting at home. Our provider immediately reached out to the member and checked in with them. At this time, the patient's only real complaint is lack of energy or getting winded when doing projects around the house. Patient will isolate at home and monitor his symptoms. Public health and the provider will follow up with the member and her family periodically to ensure recovery.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/02/2021,01/10/2021,8.0,MIL,none,none,none,,none,"['Abdominal pain upper', 'Asthenia', 'Blood pressure fluctuation', 'COVID-19 pneumonia', 'Dyspnoea', 'Exposure to SARS-CoV-2', 'Oxygen saturation decreased', 'SARS-CoV-2 test positive']",1,MODERNA,IM 951101,CO,90.0,M,"PATIENT GOT HER FIRST COVID PFIZER VACCINE AT 12/31 IN THE AM. HAD GOTTEN FLU LIKE SYMPTOMS AND HAD BEEN SICK FOR A COUPLE OF DAYS. HAD NAUSEA AND VOMITTING DURING THIS TIME AS WELL. ON 1/3 THE CARE GIVER WENT TO CHECK ON HER PT AT HER LTC FACILITY WHERE SHE LIVES AND SHE WASN'T ACTING RIGHT. SHE WAS UNABLE TO DO A STROKE EXAM. PT HAD NO MOVEMNET IN ARMS OR LEGS AND WAS UNABLE TO SPEAK. PT WAS VITALLY STABLE AT THE TIME. EMS RECORDED THAT THEY THOUGHT DIAGNOSIS WOULD BE STROKE, PNEUMONIA OR SEPSIS. AFTER ARRIVAL AT THE HOSPITIAL DETERMED THAT SHE HAD A STORKE, ACUTE KIDNEY INJURY, ABNORMAL LFTS.",Yes,01/05/2021,Not Reported,Yes,2.0,Not Reported,N,12/31/2020,01/03/2021,3.0,PHM,"metoprolol tartrate, furosemide",,"hypertension, dementia, osteoarthritis, diverticulosis",,tramadol,"['Abnormal behaviour', 'Acute kidney injury', 'Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood creatinine increased', 'Cerebral infarction', 'Cerebrovascular accident', 'Computerised tomogram head abnormal', 'Computerised tomogram thorax normal', 'Influenza like illness', 'Liver function test abnormal', 'Malaise', 'Movement disorder', 'Nausea', 'Speech disorder', 'Troponin increased', 'Vomiting', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 951104,KS,22.0,F,"allergic reaction- skin rash , throat itching. patient visited the ER and was given episode and steroids but returned because symptoms were not improving. She was hospitalized on 1/11 for this reason",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/06/2021,01/09/2021,3.0,PVT,copper IUD recently inserted nitrofurantoin,UTI,none,,none,"['Antineutrophil cytoplasmic antibody', 'Antinuclear antibody', 'Blood thyroid stimulating hormone decreased', 'Complement factor', 'Full blood count abnormal', 'Hypersensitivity', 'Leukocytosis', 'Metabolic function test', 'Neutrophilia', 'Rash', 'Respiratory viral panel', 'Throat irritation', 'Thyroxine normal']",2,PFIZER\BIONTECH,IM 951153,OH,36.0,F,"12/29/2020 Vaccination 12-13 minutes later started left arm was tight and sore. Wasn't feeling right; hot, hives, rash at injection site up neck and face; tightness in throat; tachychardic, BP increase. I took benadryl and Pepcid . Sat for another 30-45 min. Palpitations, heaviness. Transported to ER. IV and medications. Stayed till 1:30, went home, and then came that evening. 5:00 that same night, hives, chest pressure, burning sensation, 'didn't feel right', anxious. Benadryl. Tachychardic; admitted to hospital that evening. Stayed in house admission till the 12/31/2020. Went back to admission in house, 1/3/2021 - 1/4/2021. Two hospital admissions.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,prenatal; collagen supplement,knee surgery 6x weeks prior 11/4/2020,asthma; HA,,mucinex,"['Anxiety', 'Blood pressure increased', 'Burning sensation', 'Chest X-ray normal', 'Chest discomfort', 'Discomfort', 'Echocardiogram normal', 'Feeling abnormal', 'Feeling hot', 'Injection site rash', 'Pain in extremity', 'Palpitations', 'Rash', 'Skin tightness', 'Tachycardia', 'Throat tightness', 'Thyroid hormones increased', 'Urticaria']",1,MODERNA,SYR 951165,WV,48.0,F,"Approximately 28 hours after vaccine, I began to feel tingling in my right eye Approximately 12 hours after that, my face started drooping and was numb so I went to ER. Today is Sunday, and the numbness and drooping was called Bells Palsy at the hospital.",Not Reported,,Not Reported,Yes,1.0,Yes,N,01/14/2021,01/15/2021,1.0,WRK,Synthroid Vitamin d Lisinopril hctz Lipitor Multivitamin,None,Hypothyroidism,,Penicillin,"['Computerised tomogram', 'Facial paralysis', 'Hypoaesthesia', 'Laboratory test', 'Magnetic resonance imaging', 'Paraesthesia']",1,MODERNA,IM 951257,ND,63.0,F,"Injection given without unusual pain, but appeared to be at higher site than usual for other vaccinations patient has received. No immediate reactions. No redness or swelling at injection site. Approximately 3 hours later with restriction of abduction of left arm, which became worse over 24 hours. No numbnness, pain 4-5/10 diffusely over deltoid and in acromium, posterior suprascapular area.. Able to passively move arm, treated with topical Voltaren gel, Naproxyn 500 x 1 dose. D2 with increased ROM, but still restricted.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/15/2021,01/15/2021,0.0,PUB,"Felodipine, Zetia, Crestor, Toporol XL, Repatha, Vit D, B, Ma",UTI,"HTN, Familial hypercholesterolemia",,"PCN, Bactrim","['Injected limb mobility decreased', 'Pain in extremity', 'Product administered at inappropriate site']",1,MODERNA,IM 951276,PA,79.0,M,"New onset leukopenia/neutropenia with fever, unclear if related to vaccination, but temporally occurred the day after receiving 1st dose. No labs immediately prior to vaccination, so leukopenia may have preceded vaccine. No other new medications to explain neutropenia. Off chemotherapy since 8/2020. Possible relapsed disease though no other evidence in support of this as remainder of CBC stable.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/13/2021,01/14/2021,1.0,PVT,"amlodipine, aspirin, atorvastatin, carvedilol, vitamin d, gabapentin, lisinopril",Multifocal pneumonia,"CLL in remission, not on treatment Coronary disease Hypertension Hyperlipidemia Warthin's tumor",,,"['Haemoglobin decreased', 'Leukopenia', 'Neutropenia', 'Neutrophil count decreased', 'Platelet count decreased', 'Pyrexia', 'White blood cell count decreased']",1,MODERNA,IM 951283,FL,81.0,M,"Shortness of breath, Congestive heart failure, Afib",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/12/2021,01/12/2021,0.0,PVT,"Metformin, Rampiril, Amlopidine, Cilostazol, Crestor, Folic Acid",,"High Blood Pressure, Diabetes, COPD",,Aspirin,"['Atrial fibrillation', 'Cardiac failure congestive', 'Dyspnoea', 'Echocardiogram']",1,MODERNA,SYR 951354,NY,36.0,F,"Patient presented with diffuse petechiae, easy bruising and oral bruises. She has a history of stable ITP with her last required infusion of IVIG 12 years prior during pregnancy and monitors her CBC every 6 months. Her baseline platelet count is ~50-60k. She received treatment with dexamethasone 40 mg IVPB x 3 doses and IVIG 95 grams (1 gram/kg) IVPB x 2 doses.",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,12/23/2020,01/08/2021,16.0,OTH,Ibuprofen NuvaRing,None,ITP,,"Tylenol (swelling, urticaria/hives)","['Anisocytosis', 'Blood smear test abnormal', 'Haematocrit normal', 'Haemoglobin normal', 'Increased tendency to bruise', 'Oral contusion', 'Petechiae', 'Platelet count decreased', 'Polychromasia', 'Thrombocytopenia', 'White blood cell count increased']",1,MODERNA,IM 951379,NJ,57.0,M,"3 days after receiving the first dose of the vaccine on 12/21/2020, experienced flu-like symptoms that lasted 24 hours. About 17 hours after receiving the second does on 1/11/2021, flu-like symptoms reoccurred. The following day (1/13/2021) severe chills, and difficulty breathing occurred. Patient was admitted to Medical Center, where blood work, EKG, and oxygen were given and ordered. After overnight observation, the patient was discharged and informed that he had a severe reaction due to the Pfizer vaccine for Covid-19. As of 1/17/2021, patient still recovering and feeling generally weak and tired without much appetite.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/11/2021,01/13/2021,2.0,PVT,"Potassium Citrate, prednisone, levothyroxine",None,"Chronic Kidney Disease, Vasculitis",,None,"['Asthenia', 'Blood creatinine increased', 'Cardiac murmur', 'Chills', 'Decreased appetite', 'Dyspnoea', 'Electrocardiogram abnormal', 'Fatigue', 'Influenza like illness', 'Red blood cell count increased', 'SARS-CoV-2 test negative', 'Vaccination complication']",2,PFIZER\BIONTECH,SYR 951412,UT,86.0,M,"Vaccine was administered on 1/12/21 at Memory Care. On 1/15/21 at 12:30 he developed slurred speech at his facility and slumped to his left side. Out of concern for stroke he was sent by ambulance to Hospital. There he was found to have no evidence of stroke on MRI or CT angiogram. He was admitted to the hospital due to fever and elevated inflammatory markers (ferritin, CRP) and transaminases. He was found to have a positive SARS-CoV-2 PCR and IgG. His symptoms resolved the following morning and may have represented a TIA. He had many markers consistent with COVID-19 and his CT pulmonary angiogram did show ground glass opacities but no pulmonary embolism. It was difficult to assess if this was a reinfection with COVID-19, persistent PCR positivity from November, or an adverse event to the vaccine.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/12/2021,01/15/2021,3.0,PVT,"Miralax, famotidine, quetiapine, diclofenac","Positive SARS-CoV-2 PCR, also was positive on 11/2/20","Atrial fibrillation, dementia, TIA",,None,"['Alanine aminotransferase increased', 'Angiogram cerebral normal', 'Angiogram pulmonary abnormal', 'Arteriogram carotid abnormal', 'Aspartate aminotransferase increased', 'Blood alkaline phosphatase increased', 'Blood bilirubin normal', 'Blood immunoglobulin G increased', 'Blood lactate dehydrogenase increased', 'Blood triglycerides normal', 'Brain natriuretic peptide increased', 'Bronchial wall thickening', 'Bronchitis', 'C-reactive protein increased', 'Carotid arteriosclerosis', 'Cerebral atrophy', 'Cerebral small vessel ischaemic disease', 'Dysarthria', 'Fibrin D dimer', 'Inflammatory marker increased', 'Lung hypoinflation', 'Lung opacity', 'Magnetic resonance imaging brain abnormal', 'Posture abnormal', 'SARS-CoV-2 test positive', 'Serum ferritin increased', 'Transaminases increased', 'Troponin']",1,PFIZER\BIONTECH,IM 951424,NV,33.0,F,"12/27 vaccination woke up, I felt lethargic, nauseous, very sore arm (couldn't lift arm) Have felt this way with flu shot; 'semi - normal' to have this type of reaction I felt better by 3PM the next day 3rd pregnancy;",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/27/2020,12/28/2020,1.0,PUB,prenatals,,,flu shot; 2019 ; same symptoms,percoset (sensitivity),"['Exposure during pregnancy', 'Lethargy', 'Mobility decreased', 'Nausea', 'Pain in extremity']",1,MODERNA,SYR 951482,WI,23.0,F,"I received the dose at 1:45 pm on 1/13/2021 at Medical Center. Almost 1 hour post vaccine I started to feel a lump in my throat, as the minutes passed my throat started to feel tighter and fight and flight mode kicked in. It was hard to swallow, my tongue was swelling and I called EMS at 2:40 pm 1/13/2021. EMS noticed hives on my chest and left arm where I got the first dose of Moderna. I received epinephrine IM and IV benadryl in the ambulance. I was sinus tachycardic with heart rate in the 140s oxygen was 99% room air, lungs clear.. I was taken to ER where I was on observation for 2 hours. I was discharged around 5:10 pm on 1/13/2021. On my car ride home around 5:40pm I again started to feel my throat tighten, tongue swell, and heart race. I called EMS again, and was treated with IV benadryl, and epinephrine IM. I was taken to Medical Center where I was given IV solu-medrol and got blood taken and a pregnancy test done. My potassium was 3.1 and I took 2 potassium tablets to supplement. My EKG was normal sinus tach, oxygen 100% room air, blood pressure 140s/90s and got down to 120/80s. I was transported to another Medical Center for overnight observation because first Medical Center was full.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/13/2021,01/13/2021,0.0,PVT,Mirena IUD inserted February 2019 Vitamin D supplements,,,,Sulfa antibiotics - rash Moderna - anaphylaxis,"['Anion gap', 'Basophil count decreased', 'Basophil percentage decreased', 'Blood calcium normal', 'Blood chloride increased', 'Blood creatinine normal', 'Blood glucose normal', 'Blood potassium decreased', 'Blood sodium normal', 'Blood urea nitrogen/creatinine ratio', 'Blood urea normal', 'Calcium ionised normal', 'Carbon dioxide normal', 'Dysphagia', 'Electrocardiogram normal', 'Eosinophil count decreased', 'Eosinophil percentage decreased', 'Glomerular filtration rate normal', 'Granulocyte count decreased', 'Granulocyte percentage', 'Haematocrit increased', 'Haemoglobin normal', 'Human chorionic gonadotropin negative', 'Injection site urticaria', 'Lymphocyte count decreased', 'Lymphocyte percentage decreased', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin increased', 'Mean cell volume increased', 'Monocyte count normal', 'Monocyte percentage decreased', 'Neutrophil count normal', 'Neutrophil percentage increased', 'Palpitations', 'Platelet count normal', 'Red blood cell count normal', 'Red cell distribution width normal', 'Sensation of foreign body', 'Sinus tachycardia', 'Swollen tongue', 'Throat tightness', 'Urticaria', 'White blood cell count normal']",1,MODERNA,IM 951522,AK,61.0,F,Ventricular fibrillation- Code blue,Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/14/2021,01/16/2021,2.0,PVT,Albuterol Levothyroxine Duloxetine sucralfate,,Depressive disorder Fibromyalgia Kidney disease,,Pseudoephedrine Tetracycline,"['Brain natriuretic peptide', 'Cardio-respiratory arrest', 'Full blood count', 'Troponin', 'Ventricular fibrillation']",1,PFIZER\BIONTECH,IM 951557,ID,73.0,M,Initially he noticed some soreness in the left arm but it progressed overnight and now had increased weakness and difficulty standing or walking. Because of his symptoms he was brought into the emergency room for evaluation. They confirmed fairly significant weakness where he requires assistance to get in and out of his chair and bed. Laboratory testing was unremarkable as per cause of his weakness as well as his diagnostic tests were negative. This point is felt that he may be having an adverse reaction to the Covid vaccine where he had an active Covid infection just over a month ago. He is being admitted to the hospital for strengthening monitoring and further evaluation. He was brought into the hospital and treated with steroids and supportive care as well as continuation of his home medical regimen. After a good night sleep he actually looked better in the morning with less tiredness and drooping of his facial expressions. He also is able to walk with therapy with what they described as adequate for return to living at his independent living center.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/15/2021,01/16/2021,1.0,SEN,"cyanocobalamin, calcium carbonate, sotalol, dulaglutide, glimepiride, nitroglycerin, pioglitazone, ergocalciferol, metformin, evolocumab, losartan, apixaban, pregabalin, simvastatin, pantoprazole, insulin glargine, albuterol",,Diabetes Mellitus,,NKDA,"['Asthenia', 'Dysstasia', 'Facial paralysis', 'Fatigue', 'Gait disturbance', 'Laboratory test', 'Loss of personal independence in daily activities', 'Pain in extremity']",1,UNKNOWN MANUFACTURER,IM 951560,FL,33.0,M,"Severe Right sided chest pain, right sided muscle spasms and difficulty breathing two weeks after vaccine was administered Diagnosis of bilateral pulmonary embolism was made on presentation to ER. No personal or family history of clots in arteries or deep veins or any risk factors in patient. Received heparin drip, pain medications, muscle relaxants inpatient. Pain progressively improved over days. Was discharged after 6 days on admission. Was discharged on oral anticoagulant (Rivaroxaban aka xarelto)",Not Reported,,Yes,Yes,6.0,Not Reported,Y,12/19/2020,01/03/2021,15.0,PVT,"Ibuprofen, Tylenol",None,"Migraine, Hyperlipidemia",,"Sulfa Drugs, Chloroquine","['Activated partial thromboplastin time prolonged', 'Antiphospholipid antibodies positive', 'Beta-2 glycoprotein antibody negative', 'Cardiolipin antibody negative', 'Chest pain', 'Computerised tomogram thorax', 'Dyspnoea', 'Fibrin D dimer increased', 'Gene mutation identification test negative', 'Muscle spasms', 'Protein C', 'Protein S normal', 'Pulmonary embolism', 'Pulmonary infarction', ""Russell's viper venom time normal""]",1,PFIZER\BIONTECH,IM 951572,CA,31.0,F,"Developed dizziness and nausea within 90minutes of vaccine; then developed tingling, and flushing of my skin. Then rapid heart rate and chest tightness by 2.5hrs post vaccine. I went to urgent Care and they thought it was an allergic reaction (BP 182/90, HR 82) and gave me 125mg solumedrol and Benadryl intramuscularly which caused worsened dizziness and a racing heart which caused me to collapse and they gave me a epi pen and called 911. I was transferred to ER and they completed EKG which was normal and monitored vitals for a few hours and I was released. I continue to remain extremely dizzy and nauseated 2days after the vaccine.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,WRK,"Humalog, metformin, levothyroxine",None,Type 1 diabetes,,None.,"['Chest discomfort', 'Dizziness', 'Electrocardiogram normal', 'Flushing', 'Heart rate increased', 'Nausea', 'Palpitations', 'Paraesthesia', 'Syncope']",1,MODERNA,IM 951604,MN,63.0,F,"2.5 hours after receiving vaccine, I started getting dizzy and vomiting. I vomited 6 or 7 times. I was so dizzy I couldn't open my eyes without getting sick. We called ER and explained that we thought I was having a reaction to the vaccine, and their response was they had never heard of that type of reaction. I was sick all night, called my primary Dr in the am and they told me to go to ER. We had to call ambulance to take me there because I was so sick and couldn't open my eyes without having to vomit. Room spun in circles. My arrival at ER, they did MRI, EKG, blood work. My blood pressure was very high, so they connected me to a heart monitor. I had low Magnesium due to vomiting so much. I was treated with Valium and anti-vert medication and fluids. I stayed overnight in hospital- had PT Jan 13th for DX of Vertigo. Then referred to Outpatient PT for Vertigo. Dr's felt it was a ""coincident"" that I got Vertigo shortly after vaccine, and strongly felt it was not related. . Today is Jan 17th, and I am still dizzy, but feeling better. I have an appointment with my primary Jan 18th and not sure if I should take the 2nd dose. That is the question.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/11/2021,01/11/2021,0.0,PVT,"Zoloft, multi vitamin, D-3 , Omega 3",NONE,None,,"penicillin, sulfur, contrast dye, latex","['Blood magnesium decreased', 'Blood test normal', 'Dizziness', 'Electrocardiogram normal', 'Hypertension', 'Magnetic resonance imaging normal', 'Malaise', 'Vertigo', 'Vomiting']",1,PFIZER\BIONTECH,SYR 951659,IN,30.0,M,Acute Appendicitis,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/05/2021,01/13/2021,8.0,PVT,None,None,None,,None,"['Appendicitis', 'Computerised tomogram abdomen', 'Computerised tomogram pelvis']",2,PFIZER\BIONTECH,IM 951678,CA,75.0,M,Heart attack death medical test,Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/17/1921,,PVT,"Crestor 20 mg, Claritin-D 24 hour, Zaria 10 mg, baby aspirin, replatha,valsart hits 160-12.5mg Fish oil, wheat germ oil, D3 1000 mg, testosterone 8% gel, CO Q 10, weirder prime , eye drops",None,None,,None,"['Death', 'Myocardial infarction']",2,PFIZER\BIONTECH, 951688,AR,63.0,M,Resident expired 1/17/21,Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/17/2021,15.0,SEN,"Diclofenac Sodium Gel 1 %, Atorvastatin Calcium Tablet 40 MG, Acetaminophen Tablet 325 MG, Melatonin Tablet 3 MG, Vitamin D3 Tablet 25 MCG, Iron Tablet 325, Multivital-M Tablet, Eliquis Tablet 5 MG, metFORMIN HCl Tablet 500 MG, NIFEdipine",11/25/20 Lower mid back abscess 11/4/20 toenail removal,"CEREBRAL INFARCTION DUE TO UNSPECIFIED OCCLUSION OR STENOSIS OF LEFT MIDDLE CEREBRAL ARTERY, PRESENCE OF AUTOMATIC (IMPLANTABLE) CARDIAC DEFIBRILLATOR, UNSPECIFIED OSTEOARTHRITIS, UNSPECIFIED SITE, APHASIA, DYSPHAGIA, UNSPECIFIED, WEAKNESS, COVID-19, OTHER REDUCED MOBILITY, URINARY TRACT INFECTION, SITE NOT SPECIFIED, ABNORMAL WEIGHT LOSS, TYPE 2 DIABETES MELLITUS WITHOUT COMPLICATIONS, VITAMIN DEFICIENCY, UNSPECIFIED, VITAMIN D DEFICIENCY, UNSPECIFIED, ANEMIA, UNSPECIFIED, CHRONIC COMBINED SYSTOLIC (CONGESTIVE) AND DIASTOLIC (CONGESTIVE) HEART FAILURE, CHRONIC KIDNEY DISEASE, STAGE 2 (MILD), ESSENTIAL (PRIMARY) HYPERTENSION, GOUT, UNSPECIFIED, INSOMNIA, UNSPECIFIED",,No Known Allergies,['Death'],1,MODERNA,IM 951689,,29.0,F,29yo female patient reports feeling her throat tingling and closing sensation in her throat with a metallic taste and diaphoretic approximately 3 minutes after receiving vaccine. She did not report these sensations until about 15min after injection. EMS assist was immediately called and pt was brought into one of the patient rooms. She was given Epipen injection approx. 20min after injection and EMS arrived to transport patient down to ER within 1-2 minutes after Epipen administered. Patient was monitored in ER and recovered well,Not Reported,,Yes,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,MIL,no,no,no,,no,"['Dysgeusia', 'Hyperhidrosis', 'Pharyngeal paraesthesia', 'Throat tightness']",UNK,PFIZER\BIONTECH, 951720,MS,66.0,F,rash on the arm and side of my body where the injection was given. i took some Benadryl on 01/14/2021 the rash came back and the injection spot became really warm and harden. i took Benadryl again it went away. the rash came back 01/16/2021 and i took more Benadryl and the itcing stop. isaw a few red spots on my arm today bot no itching.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,WRK,lisinopril/hctz 10-12.5mg super collagen+c with biotin omega 3-6-9vitmin D,none,high blood pressure,,penicillin,"['Erythema', 'Injection site induration', 'Injection site warmth', 'Pruritus', 'Rash']",UNK,MODERNA, 951738,WA,29.0,F,"lymphadenopathy on left side (starting in axillary and progressing to supraclavicular and eventually neck as well. swollen and extremely tender) in addition to normal side effects of chills, fatigue. also was having irregular heart rhythm (reason for hospitalization) do not know if the heart rhythms are related to the vaccine or not, onset was a few days after vaccination (ER 12/30/2020, then another hospital 1/1-1/2). but the hospitalization below is referring to the heart rhythm not the lymphadenopathy.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/26/2020,12/29/2020,3.0,PVT,"daily: Zyrtec 10mg, Ritual prenatal vitamin",,,,seasonal allergies,"['Chills', 'Fatigue', 'Heart rate irregular', 'Lymph node pain', 'Lymph node palpable', 'Lymphadenopathy']",1,MODERNA,IM 953201,WI,33.0,M,"I was diagnosed with COVID-19 on 12/7/2020. My course of symptoms lasted 16 days, meaning I started feeling healthy again on 12/23/20. I am a pharmacist with a healthcare system and they have been offering the Pfizer/Biontech COVID-19 vaccine for essential associates. I received by first dose of vaccine on 12/31/20. On 1/1/20 I woke up with very noticeable muscle aches and fairly profound lethargy, which last 18-20 hours. I was not able to do much on 1/1/21 because of the way I was feeling. I'm not sure if this reaction is normal for patients who receive their COVID-19 vaccine close to their illness/infection with COVID-19, which is why I'm reporting this to the FDA.",Not Reported,,Not Reported,Not Reported,,Yes,,12/31/2020,01/01/2021,1.0,UNK,"Famotidine 40 mg daily, TUMS 1-2 tablets daily prn, APAP 500 mg daily prn, Magnesium tablets 500 mg daily, Voltaren OTC gel apply to affected area daily prn",None,None,,,"['Lethargy', 'Myalgia']",UNK,PFIZER\BIONTECH, 953255,CA,,M,"I received the Pfizer vaccine on 12/21/20 without adverse events other than soreness in deltoid. On 12/31/20 I began to notice pain, redness and swelling in second toe on R foot from base of toe to base of nail. I initially thought it was gout and self medicated with ibuprofen 400 mg BID x 1 day on 01/01/21 with some improvement. I did not take anything on 01/02/21 and woke up on 01/03/21 with return of swelling, redness and pain. I took another 400 mg of ibuprofen and it felt better but after examining the toe, I questioned whether I had developed pernio (COVID toe).",Not Reported,,Not Reported,Not Reported,,Yes,,12/21/2020,12/31/2020,10.0,UNK,"ATORVASTATIN, EPLERENONE, EZETAMIBE, CITALOPRAM, JARDIANCE, ENTRESTO, XARELTO, CARVEDILOL, ASA, FOLATE",,ISCHEMIC CARDIOMYOPATHY,,NKA,"['Erythema', 'Myalgia', 'Pain in extremity', 'SARS-CoV-2 test', 'Swelling']",UNK,PFIZER\BIONTECH,IM 954166,NY,44.0,F,"Received Moderna COVID vaccine 12/31/20, 3 days later noticed generalized joint pain all over. Day 4 noticed both knees were red and tender and could palpate pockets of fluid. Had bilateral ankle and foot pain, right ankle swollen. Overnight 1/5-1/6/21 was in severe pain and unable to sleep, very difficult to walk on ankles and feet, stairs were very painful. Motrin relieved symptoms to where able to walk more comfortably but generalized achiness and tenderness to ankles and knees remain.",Not Reported,,Not Reported,Not Reported,,Yes,,12/31/2020,12/31/2020,0.0,UNK,,,,,,"['Arthralgia', 'Erythema', 'Fluid retention', 'Gait disturbance', 'Joint swelling', 'Oedema peripheral', 'Pain', 'Pain in extremity', 'Sleep disorder', 'Tenderness']",UNK,MODERNA,IM 954167,AZ,,F,"This is a report about me. I received my Covid vaccine on Sunday after my hospital shift (it was first dose of the Pfizer vaccine). Other than some muscle soreness, which I expected, I started experiencing numbness and tingling in the arm that received the shot (my left arm). It is now 4 days later, and the numbness/ tingling is not any better. I don't know if this is a frequent side effect that will go away in time, but it is very concerning to me.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/03/2021,01/03/2021,0.0,UNK,,,,,"I only have sensitivities to Erythromycin (GI upset) and Clindamycin (""black hairy tongue"")","['Hypoaesthesia', 'Myalgia', 'Paraesthesia']",UNK,UNKNOWN MANUFACTURER,IM 954168,AR,,F,Anaphylaxis after Covid 19 vaccine #1. Pfizer Lot # EH9899,Not Reported,,Not Reported,Yes,,Not Reported,,12/31/2020,12/31/2020,0.0,UNK,,,unknown,,,['Anaphylactic reaction'],UNK,PFIZER\BIONTECH,IM 954169,OH,53.0,F,I was given the Fluzone Quad vaccine in left arm on 10 19 2020. This injection is suppose to be given intramuscularly. It was given in errant location and as a result a permanent 2.5in diameter and 0.5in deep soft tissue defect resulted by the 4th post-injection day and remains unchanged.,Not Reported,,Not Reported,Not Reported,,Yes,,10/19/2020,10/19/2020,0.0,UNK,none,none,none,,none,"['Incorrect route of product administration', 'Magnetic resonance imaging abnormal', 'Product administered at inappropriate site', 'Soft tissue disorder']",UNK,SANOFI PASTEUR,SC 954926,CA,,M,6 hours after receiving 2nd dose of Pfizer COVID-19 vaccine I began experiencing palpitations. Using mobile device it appears to be PACS. Sustained.,Not Reported,,Not Reported,Not Reported,,Not Reported,,,01/08/2021,,UNK,,,None,,None,['Palpitations'],UNK,PFIZER\BIONTECH, 955042,TX,,M,"Standard side effect, it seems, just reporting for tracking. EXTREME tiredness/lethargy 36-72 hours after Pfizer Bion Tech vaccine dose 2. No other side effects, did not require any medical treatment, self-resolved with time.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/09/2021,01/11/2021,2.0,UNK,"Edarbyclor, Metformin, Trulicity, Freestyle Libre 2 C CGM, Zyrtec",,"Diabetes, Hypertension, Hyperlipidemia",,Pollen. NKDA.,"['Fatigue', 'Lethargy']",UNK,PFIZER\BIONTECH,SC 955056,CA,55.0,F,I received the first COVID vaccine from Pfizer. At first I experienced only mild side effects such as headache and fatigue and dizziness. That night I awake with severe stabbing abdominal pain. I couldn't sleep much of the night due to pain. The pain continued until the following day. I had to take the day off work due to fatigue and pan. I have a couple of autoimmune diseases and I surmised this is why the vaccine affected me in this way,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,UNK,"Hydrocortisone, florinef acetate",,"Addison's disease, gluten intolerance",,Papaya,"['Abdominal pain', 'Dizziness', 'Fatigue', 'Headache', 'Impaired work ability', 'Pain', 'Sleep disorder']",UNK,PFIZER\BIONTECH, 955087,CA,,F,I received the first COVID vaccine from Pfizer. At first I experienced only mild side effects such as headache and fatigue and dizziness. That night I awoke with severe stabbing abdominal pain. I couldn't sleep much of the night due to pain. The pain continued until the following day. I had to take the day off work due to fatigue and pain. I have a couple of autoimmune diseases and I surmised this is why the vaccine affected me in this way.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,UNK,"Hydrocortisone, florinef acetate",,"Addison's disease, gluten intolerance",,Papaya,"['Abdominal pain', 'Dizziness', 'Fatigue', 'Headache', 'Impaired work ability', 'Sleep disorder']",UNK,PFIZER\BIONTECH,OT 955091,NV,,M,"Pt rec'd flu vaccine (lot # 2202: UJ535AB) at a pharmacy on 11/16/2020. The next day he developed right hemifacial spasm and palatal myoclonus. 11/17/2020 BRAIN MRI showed a small left frontal non-enhancing lesion, initially thought to possibly be a subacute stroke. However, he worsened and developed anarthria, aphagia, right arm wkns, and aspiration pneumonia necessitating intubation. Repeat BRAIN MRI 11/24/2020 was worse. He had the 1st of 2 brain biopsies 11/28/2020, which pathology was resulted as ""reactive changes"" but was non-diagnostic. He had add'l BRAIN MRIs that showed continued worsening of the left hemisphere lesion and subsequent involvement of the right hemisphere. A 2nd brain brain biopsy was done 12/16/2020, which pathology was also resulted as ""reactive changes"" but was also non-diagnostic. The pt has a h/o ""low-grade"" T-cell lymphoma, but neither biopsy samples had evidence of lymphoma in CNS or of obvious features to suggest other neoplasm, vasculitis, granulomatous disease, infection, or demyelination. This is a very odd / challenging case. Initially despite the timing I did not consider the flu vaccine to be relevant / causative. However, there is no other obvious possible etiology. Hence I would consider the flu vaccine probably related to his CNS problem and a serious adverse reaction. He eventually started having seizures. He remains in a coma on life support. His family is going to withdraw care 1/8/2020.",Yes,,Yes,Yes,,Yes,,11/16/2020,11/16/2020,0.0,UNK,,,,,,"['Aphasia', 'Biopsy brain abnormal', 'Central nervous system lesion', 'Coma', 'Dysarthria', 'Dysphagia', 'Endotracheal intubation', 'Facial spasm', 'Life support', 'Magnetic resonance imaging brain abnormal', 'Muscular weakness', 'Myoclonus', 'Pneumonia aspiration', 'Seizure']",UNK,SANOFI PASTEUR, 955172,MD,77.0,F,Severe pain deep in left buttocks hip area. Began 01/14/21 am and continuing Now. Taking Aleve every 12 hours for some relief Pfizer COVID Vaccination on 01/13/21 at 7:27 am at medical center. Vaccination in right arm. I am 77.5 years old. Is there a drug interaction between Valtrex and the COVID vaccine?? I take Valtrex daily. Help,Not Reported,,Not Reported,Not Reported,,Not Reported,,,01/14/2021,,UNK,Valtrex Lipitor Topofil; Calcium and Vit D Vit C,,High blood pressure controlled,,Shrimp,"['Arthralgia', 'Musculoskeletal pain']",UNK,PFIZER\BIONTECH, 955173,AR,,F,Anaphylaxis after Covid 19 vaccine #1. Pfizer Lot # EH9899,Not Reported,,Not Reported,Yes,,Not Reported,,12/31/2020,12/31/2020,0.0,UNK,,,unknown,,,['Anaphylactic reaction'],UNK,PFIZER\BIONTECH,IM 955186,CO,50.0,M,"[BioNTech COVID-19] treatment under Emergency Use Authorization(EUA):BioNTech Pfizer COVID-19 Vaccination. Two vaccinations given. Mild arm tenderness associated with 1st dose. Second dose administered 20 days after 1st dose resulted in adverse effects (AE) approximately 40-43 hours after 2nd dose was administered. AEs involved nausea, malaise, flu-like symptoms, mild fever, chills, body aches, gastritis and diarrhea. AEs lasted approximately 4-5 hours. Fatigue lingered for approx. 12 hours. Patient felt normal upon awakening next morning with no additional or lingering AEs to report since experiencing AEs from 2nd dose of BioNTech vaccine. 650mg acetaminophen was taken during 2nd dose experience with AEs. Acetaminophen did alleviate severity of symptoms slightly. Patient had loss of appetite due to AEs experienced. Patient was able to consume water without complications. No mental effects only tiredness from symptoms were experienced.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/08/2021,2.0,UNK,acetaminophen 650mg,,,,,"['Adverse event', 'Chills', 'Decreased appetite', 'Diarrhoea', 'Fatigue', 'Gastritis', 'Inappropriate schedule of product administration', 'Influenza like illness', 'Malaise', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 955248,,38.0,F,"Covid vx Pfizer Swollen lymph nodes under arm on the same side as injection site. Fatigue, nausea, chills, body aches, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,,,01/13/2021,,UNK,,,,,,"['Chills', 'Fatigue', 'Lymphadenopathy', 'Nausea', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 955256,FL,88.0,M,"Patient was vaccinated in right arm. Within 5 to 10 seconds after vaccination, patient started clinching his hands tightly and became unresponsive. Patient was lowered to the floor and did not exhibit a pulse. CPR was initiated and 911 was called. An AED was used and healthcare professionals onsite continued compressions until the paramedics arrived.",Yes,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/16/2021,0.0,SEN,None listed,None Listed,None Listed,,None Listed,"['Cardioversion', 'Immediate post-injection reaction', 'Muscle contractions involuntary', 'Pulse absent', 'Resuscitation', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 955396,,,F,Pfizer name] treatment under Emergency Use Authorization(EUA): Second dose receive 1/8/21 at 9 am - by 11 pm severe chills and am 1/9 substantial headache and body aches. Feel like I was hit by bus. Significant nasal congestion noted/,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/08/2021,0.0,UNK,,,,,,"['Chills', 'Headache', 'Malaise', 'Nasal congestion', 'Pain']",2,PFIZER\BIONTECH, 951799,MO,56.0,F,"The patient received her first Moderna COVID-19 vaccination on 12/29/2020. However the patient was diagnosed with a positive COVID-19 test on January 4, 2021. Patient complained of nausea, vomiting, back pain, and sharp chest pain. On January 13, the patient presented to the emergency department again with shortness of breath and sharp, stabbing left-sided chest pain radiating to her back and right side. Initial work up ruled out cardiac etiologies. CTA chest demonstrated COVID-19 pneumonia. The patient complained of bilateral lower extremity weakness which had been progressing since her COVID-19 vaccination, per patient report. However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate. On the 13th, the patient was able to ambulate to and from the bathroom herself. Then on January 14 the patient required maximum assistance. Neurology was consulted and work up initiated for suspected possible Guillain-Barr� syndrome (GBS) secondary to recent COVID-19 infection. On January 15, 2021, the patient became obtunded and unable to protect airway. She was emergently intubated for acute hypercapnic respiratory failure secondary to GBS. Neurology started GBS treatment with IVIG. Patient also developed NSTEMI and Takotsubo cardiomyopathy. Patient remains critically ill requiring mechanical ventilation.",Not Reported,,Yes,Yes,,Not Reported,N,12/29/2020,01/01/2021,3.0,PVT,atorvastatin (LIPITOR) 10 MG tablet glipiZIDE (GLUCOTROL XL) 10 MG 24 hr tablet losartan (COZAAR) 25 MG tablet metformin (GLUCOPHAGE) 1000 mg tablet pantoprazole (PROTONIX) 40 mg tablets,,? Diabetes mellitus ? Hyperlipidemia � ? Hypertension � ? Sleep apnea,,Phenergan Dm,"['Acute myocardial infarction', 'Angiogram cerebral', 'Arteriogram carotid', 'Back pain', 'Blood gases', 'COVID-19 pneumonia', 'Catheterisation cardiac', 'Chest X-ray', 'Chest pain', 'Computerised tomogram thorax', 'Critical illness', 'Depressed level of consciousness', 'Dyspnoea', 'Echocardiogram', 'Electrocardiogram', 'Endotracheal intubation', 'Flank pain', 'Full blood count', 'Gait disturbance', 'Guillain-Barre syndrome', 'Immunoglobulin therapy', 'Lumbar puncture', 'Mechanical ventilation', 'Metabolic function test', 'Muscular weakness', 'Nausea', 'Pain', 'Respiratory failure', 'SARS-CoV-2 test positive', 'Stress cardiomyopathy', 'Troponin', 'Vomiting']",UNK,MODERNA, 951817,HI,43.0,M,"The day after receiving the second vaccination, I began to have mild intermittent abdominal pain2-3/10. The pain gradually increased, became more intense, and more constant. Mild fever and chills started happening, and I took Ibuprofen. By about 4 days after the vaccine, the abdominal pain was severe enough that I had some difficulty walking and I couldn?t sleep at night. Pain was 6-8/10. I went to the ER, and CT scan with IV contrast showed 18 mm appendicitis. I underwent laparoscopic surgery and it was found to be perforated. It was removed. I am currently recovering in the hospital. I received the vaccine as a health care provider at my hospital, specifically I am a practicing pediatrician physician for over 10 years.",Not Reported,,Yes,Yes,3.0,Not Reported,U,01/13/2021,01/14/2021,1.0,PVT,None,Strep throat about a week prior to vaccination,None,,"Shrimp, crab, lobster","['Abdominal pain', 'Appendicectomy', 'Appendicitis perforated', 'Chills', 'Gait disturbance', 'Laparoscopic surgery', 'Pyrexia', 'Scan with contrast abnormal', 'Sleep disorder']",2,PFIZER\BIONTECH,SYR 951887,MN,,F,"Guillain-Barre syndrome; other zoster-related conditions; Information has been received from an attorney regarding a case in litigation, concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. In on about 01-JAN-2016, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions, at a clinic. On unspecified date, the patient was treated by healthcare providers for Guillain-Barre Syndrome and other zoster-related conditions (Ill-defined disorder). As a direct and proximate result of patient's use of the vaccine, she had and would continue to suffer ongoing injuries, including but not limited to medical care and treatment for these injuries, medical losses and costs include care for hospitalization, monitoring treatment, medications and supplies. At the time of the report, the patient was not recovered from the adverse events. The reporter considered Guillain-Barre Syndrome and zoster-related conditions to be related to Zoster Vaccine Live (ZOSTAVAX) vaccine. Upon internal review, the event of Guillain-Barre syndrome was considered medically significant.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/01/2016,,,OTH,,,,,,['Guillain-Barre syndrome'],UNK,MERCK & CO. INC., 951888,CA,,U,"herpes zoster, postherpetic neuralgia, and vision problems.; herpes zoster, postherpetic neuralgia, and vision problems.; herpes zoster, postherpetic neuralgia, and vision problems.; This initial spontaneous report was received from a lawyer on 11-JAN-2021, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 17-DEC-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) (no additional dosage regimen information was provided). After receiving the vaccine, on an unknown date, the patient experienced herpes zoster, postherpetic neuralgia and vision problems. As a result of these symptoms, the patient was treated by medical providers and at the time of the report was still under their care. As a direct and proximate result of vaccination, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of their condition. The patient sustained severe and permanent personal injuries. Further as a tragic consequence of vaccination, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life and physical impairment and injury. The reporter considered that herpes zoster, postherpetic neuralgia and vision problems were related to zoster vaccine live (ZOSTAVAX). The reporter considered this case as serious due to patient's disabling conditions.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/17/2013,,,UNK,,,,,,"['Herpes zoster', 'Post herpetic neuralgia', 'Visual impairment']",UNK,MERCK & CO. INC., 951889,TX,,U,"hearing loss; This initial spontaneous report was received from a lawyer on 11-JAN-2021, regarding a case in litigation and refers to a patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. In or around 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dosage regimen information was not reported) for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the patient suffered hearing loss. As a direct and proximate result of vaccination, the patient's symptoms have resulted in physical limitations not present to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. The patient sustained severe and permanent personal injuries. Further as a tragic consequence of vaccination, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life and physical impairment and injury. At the time of the report, the outcome of deafness was as not recovered. The reporter considered deafness to be related to Zoster Vaccine Live (ZOSTAVAX). The reporter considered this case as serious due to patient's disabling conditions. Upon internal review, deafness was considered to be medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Deafness'],UNK,MERCK & CO. INC., 951972,KY,69.0,F,"I felt quite sick, like I had the flu; became very lightheaded and dizzy; passed out; felt quite sick; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included R.A.D., osteopenia, migraine with aura, the patient had previously suffered episodes of vasal vagal syncopy when she got the flu or other severe illnesses, and the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included atenolol, atorvastatin, azelastine, and fluticasone. The patient previously took gramicidin, neomycin sulfate, polymyxin b sulfate (NEOSPORIN) and experienced allergies. The morning after receiving the vaccine, she felt quite sick, like she had the flu. When she got up from bed and went to the bathroom to urinate, she became very lightheaded and dizzy. She attempted to return to bed, but passed out on the bedroom floor before she could get to the bed, and seized while she was unconscious. Once she came to, she was helped to bed and, after about 90 minutes, felt much better, and got up, and ate food and had coffee. All events occurred at 07:30 AM on 09Jan2021. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was resolved in Jan2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,UNK,; ; ;,,Medical History/Concurrent Conditions: COVID-19; Flu; Migraine with aura; Osteopenia; Reactive attachment disorder of infancy or early childhood (R.A.D.); Syncope vasovagal,,,"['Dizziness', 'Influenza like illness', 'Loss of consciousness', 'Malaise', 'Seizure']",UNK,PFIZER\BIONTECH, 951973,VA,30.0,F,"Blacked out; Fainted; Felt very unwell; Nauseous; Chills; Fell; Knocked out, hit her nose, started to bleed; Humongous scar on her nose; In her hand there's a rash with different dots/red; She has petechiae/rash on the forearm; hit her face; knocked out, hit her nose; This is a spontaneous report from a contactable physician. This physician reported that a 30-year-old female patient (daughter) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced blacked out, fainted, felt very unwell, nauseous, chills, fell, knocked out, hit her nose, started to bleed, humongous scar on her nose, in her hand there's a rash with different dots/red, she has petechiae/rash on the forearm, all on an unspecified date in Jan2021. The Caller wanted information on side effects specifically looking at platelet or clotting or bleeding issues. Her daughter, (female, age 29 date of birth) received the 2nd dose of Pfizer vaccine, received it at the (State name), last night. She felt very unwell, nauseous, chills, and then blacked out, fell, knocked out, hit her nose, started to bleed; fainted and hit her face, didn't stop bleeding for 2 hours. There's a humongous scar on her nose. It took 2 hours to stop bleeding. She's going to urgent care today. Her daughter was healthy, yesterday was 2nd dose. In her hand, there's a rash with different dots/red. She has petechiae/rash on the forearm. Thankfully it (bleeding) did stop. The outcome of events for 'knocked out, hit her nose, started to bleed' was resolved on an unspecified date, for other events was unknown. The case was reported as non-serious. Information on the Batch/Lot number has been requested.; Sender's Comments: Based solely on a chronological association a causal relationship between events blacked out and fainted and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/01/2021,,UNK,,,,,,"['Chills', 'Epistaxis', 'Fall', 'Loss of consciousness', 'Malaise', 'Nasal injury', 'Nausea', 'Petechiae', 'Rash', 'Rash erythematous', 'Scar', 'Syncope']",2,PFIZER\BIONTECH, 951979,IN,30.0,F,"fist dose on 21Dec2020, second dose on 07Jan2021; pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back; pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back; pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back; Started having chills; Severe headache; collapsed on the way back to bathroom and was unable to get up for about 20 minutes; tachycardia; extremely fatigued entire day; This is a spontaneous report from a contactable Pharmacist who reported for herself. A 30-year-old female patient received her second dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number Ej1685) at a single dose at 09:45 AM 07Jan2021 at left arm for Covid-19 immunization in a hospital. The patient had her first dose of Pifzer Covid-19 vaccine on 21Dec2020 at 12:00 PM at left arm, and experienced very mild reactions which included mild pain at injection site and runny nose/sneezing day after vaccine. The paitent had a medical hisotry of rash to penicillin as a child. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to her first dose of Pfizer COVID vaccine. In the evening of second vaccine (around 17:00), pain and stiffness radiated from injection site all the way down arm, into breast, and middle of back. She started having chills. Around 10 hours after dose chills became somewhat violent despite being under 4 blankets. Severe headache also started. In the middle of the night to go to bathroom, she collapsed on the way back and was unable to get up for about 20 minutes. She also suffered from tachycardia overnight. her baseline heart rate runs in 60s- 70s, but was in 110s-120s (based on Apple Watch monitoring). Day after vaccine, she was extremely fatigue entire day and spent all but a few hours in bed. Arm pain mostly gone. Headache was very strong and persistent through the day. On second night chills not as bad but still occurred overnight. HR still elevated in 80s overnight. Morning of day 2 still had headache and fatigue. The patient did not receive any treatment for the events. The outcome of collapse and unable to get up for 20minutes, pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back was resolved, chills and tachycardia was resolving, headache, fatigue was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The reporter considered that the events was non-serious.; Sender's Comments: Based on a chronological temporal association and known BNT162B2 vaccine safety profile, causality between events fainting, violent chills and severe headache and BNT162B2 ((Pfizer/ BioNTech Covid-19 vaccine) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/01/2021,,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Back pain', 'Breast pain', 'Chills', 'Fatigue', 'Headache', 'Heart rate increased', 'Injection site pain', 'Injection site reaction', 'Mobility decreased', 'Musculoskeletal stiffness', 'Pain', 'Pain in extremity', 'Rhinorrhoea', 'Sneezing', 'Syncope', 'Tachycardia']",2,PFIZER\BIONTECH, 951992,VA,,F,"anaphylactic reaction/anaphylaxis; This is a spontaneous report from a Pfizer Sponsored Program from a contactable pharmacist. A female patient of an unspecified age received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine, lot number: EK4176), via an unspecified route of administration on 09Jan2021 at 0.3 mL, single (standard like 0.3ml by injection once to deltoid, side unknown) to prevent from getting COVID. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction/anaphylaxis on 09Jan2021. Clinical course: The patient got the vaccine while waiting to go into the watch room, to be watched for a few minutes, and she experienced anaphylactic reaction/anaphylaxis, she went down, they gave her an Epinephrine, she didn't respond to the first dose, a second dose was given in the arm where the vaccine was given, then she was picked up by an ambulance. Agent stated the caller has been on hold for almost an hour. Caller clarifies dose was given in the arm, it occurred on Saturday with the same lot. Saturday and it went away on Saturday, the patient was worried about it coming back, thus why she asked about Epinephrine pen, the patient was taken to the hospital, and given Epinephrine a couple more times, and it resolved eventually, the patient was not admitted, she went to the Emergency Department. It could have required hospitalization but would most likely say life threatening had she not been treated. Reporter seriousness for anaphylaxis is life threatening. The outcome of event was recovered on 09Jan2021. Relatedness of bnt162b2 to reaction anaphylaxis is related for primary source.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset anaphylactic reaction/anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,UNK,,,,,,"['Anaphylactic reaction', 'Anxiety']",1,PFIZER\BIONTECH, 952025,AZ,67.0,M,"developed symptoms for Covid/tested positive after receiving the vaccine; developed symptoms for Covid/tested positive after receiving the vaccine; developed symptoms for Covid/tested positive after receiving the vaccine; This is a spontaneous report from a contactable physician (patient) and a consumer (patient's spouse). A 67-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EH9899; expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician had a question. As a patient, he received the first dose of Pfizer BioNTech vaccine and on an unspecified date, two days later, he developed symptoms for Covid and tested positive after receiving the vaccine. He stated this had nothing to do with vaccine but had to do with the timing. He wanted to know if should take or delay vaccine. He is doing fine now. His second dose is coming up next week. The outcome of the events was recovered on an unspecified date.; Sender's Comments: The association between the event lack of effect (he developed symptoms for COVID and tested positive) with BNT162b2 can not be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 952028,NJ,,U,"got the first vaccine and then tested positive for the virus; got the first vaccine and then tested positive for the virus/fairly sick; This is a spontaneous report from Pfizer-sponsored Program IBCC (Inbound Call Center for HCPs). A contactable physician reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter is a cardiologist. He is inquiring about the COVID-19 vaccine. He had several patients (pending clarification) who got the first vaccine and then tested positive for the virus. He is asking when can they get the second dose after testing positive. He had two patients that are fairly sick now. He has had patients who have monochromal antibodies (pending clarification). He is asking when they can get the vaccine after that treatment. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events.,Linked Report(s) : US-PFIZER INC-2021022171 same reporter, similar suspect drug and event; different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 952029,NJ,,U,"got the first vaccine and then tested positive for the virus; got the first vaccine and then tested positive for the virus/fairly sick now; This is a spontaneous report from Pfizer-sponsored Program. A contactable physician reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter is a cardiologist. He is inquiring about the COVID-19 vaccine. He had several patients (pending clarification) who got the first vaccine and then tested positive for the virus. He is asking when can they get the second dose after testing positive. He had two patients that are fairly sick now. He has had patients who have monochromal antibodies (pending clarification). He is asking when they can get the vaccine after that treatment. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events.,Linked Report(s) : US-PFIZER INC-2021022153 same reporter, similar suspect drug and event; different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 952051,VA,19.0,F,"postural orthostatic tachycardia syndrome; experienced symptoms of syncope; Collapse; Heart palpitations; Dizziness; Initial information regarding an unsolicited valid serious case received from the other healthcare professional via phone at call center (Reference number: US-SANOFI-00426245) on 12-Jan-2021. This case involved a 19-year old female patient who experienced postural orthostatic tachycardia syndrome, after receiving INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (FLUZONE). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient received no concomitant medications. On 19-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED 0.5 mL multi-dose vial (lot number: UJ477AB, expiry date: 30-Jun-2021) via an unknown route in the right deltoid for prophylactic vaccination. On 22-Oct-2020, 3 days following the suspect product vaccinations, the patient experienced symptoms of syncope, collapse (Fall), heart palpitations (Palpitations), and dizziness. Reporter that the patient had visited the emergency room. After being symptomatic for a while, the patient was seen at the reporting primary care practice on 12-Nov-2020, where an electrocardiogram was performed, which was abnormal. Patient was referred to a neurologist on 11-Dec-2020, Doctor who suspected postural orthostatic tachycardia syndrome (POTS), and the patient was referred to Genetics on 21-Dec-2020. On 21-Dec-2020, 2 months 2 days following the suspect product vaccinations, at genetics, patient underwent a tilt table test, which confirmed postural orthostatic tachycardia syndrome (POTS). Patient had a follow-up appointment with neurologist on 28-Dec-2020. Final diagnosis was postural orthostatic tachycardia syndrome. The event of postural orthostatic tachycardia syndrome associated with accompanying symptoms of syncope, palpitations, dizziness and fall were assessed as important medical event as the accompanying symptom of syncope was assessed as medically significant as per important medical event list. It was not reported if the patient received a corrective treatment. Outcome of the event of postural orthostatic tachycardia syndrome with its accompanying symptoms was unknown. The neurologist and other members of the patient's healthcare team believe that the patients POTS was related to the Fluzone vaccine the patient received.; Sender's Comments: This case involved a 19-year old female patient who presented with postural orthostatic tachycardia syndrome (POTS) accompanied with symptoms of fall, dizziness, syncope and palpitations three days (although diagnosed on a later date) following INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (FLUZONE). Time to onset is compatible. Although, medical history, comorbidities, concomitant medications, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,10/19/2020,10/22/2020,3.0,UNK,,,,,,"['Dizziness', 'Electrocardiogram abnormal', 'Fall', 'Palpitations', 'Postural orthostatic tachycardia syndrome', 'Syncope', 'Tilt table test positive']",UNK,SANOFI PASTEUR,OT 952098,,33.0,F,"The day following vaccination, the patient experienced nausea/vomiting, shortness of breath, followed by extremity paresthesia, and increased heart rate. The patient went to the emergency room and was assigned an overnight admission for a potential post-vaccination adverse event. Patient was discharged the following day.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,01/13/2021,01/14/2021,1.0,UNK,,,,,,"['Dyspnoea', 'Heart rate increased', 'Nausea', 'Paraesthesia', 'Vomiting']",1,MODERNA,IM 952101,,19.0,F,"The day of vaccination, the patient presented to the emergency room with a complaint of dizziness and syncope. Reported that she became dizzy, presyncopal feelings, and had a witnessed syncopal event. The patient stated she does have vasovagal syncopal events after blood draws in the past. The patient was assigned an overnight admission for a potential post-vaccination adverse event, new onset atrial fibrillation, dehydration, and syncope. Patient was discharged the following day.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,01/14/2021,01/14/2021,0.0,UNK,,,,,,"['Atrial fibrillation', 'Dehydration', 'Dizziness', 'Presyncope', 'Syncope']",1,MODERNA,IM 952204,FL,75.0,M,Patient became sick 3 hours after the vaccine and was found deceased 1 day after his vaccination. He passed away in his sleep.,Yes,12/01/2020,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,MIL,Amoxicillin 500mg,None: Clean bill of health and a full cardiac exam was performed 2 months prior.,None.,,None,"['Autopsy', 'Death', 'Malaise']",1,PFIZER\BIONTECH,IM 952228,KS,87.0,F,No known symptoms,Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/17/2021,11.0,SEN,"Omeprazole, Levothyroxine, Amlodipine, Ezetimibe, Dicyclomine, triamcinolone",,"HTN, High Cholesterol ,IBS",,Unknown,['Unevaluable event'],1,UNKNOWN MANUFACTURER,UN 952235,MS,65.0,F,nausea and vomiting possible cause of diabetic ketoacidosis and svt,Not Reported,,Yes,Yes,4.0,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,amaryl. Lasix. metformin. Mirapex. Toprol-xl. victoza. tresiba. amiodarone. eliquis. dilacor. crestor.,,type 2 diabetes. SVT,,,"['Condition aggravated', 'Diabetic ketoacidosis', 'Electrocardiogram', 'Laboratory test', 'Nausea', 'Supraventricular tachycardia', 'Vomiting']",1,MODERNA,SYR 952248,NY,,U,"stroke; Bells palsy; postherpetic neuralgia; herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. The pt's concurrent conditions, medical history an concomitant medications were not reported. On 24-AUG-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) in a pharmacy (exact dose, site and route of administration, lot# and expiration date were not reported) for the long term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated for the following injuries, resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster, post herpetic neuralgia, Bell's palsy and stroke. The outcome of the events was unknown. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was reported as related. Upon internal review, the events of Bell's palsy and stroke were determined to be medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,08/24/2015,,,PHM,,,,,,"['Cerebrovascular accident', 'Facial paralysis', 'Herpes zoster', 'Post herpetic neuralgia']",UNK,MERCK & CO. INC., 952256,AZ,,M,"has a history of skin cancer / did a biopsy showed squamous cancer / left leg in two areas had cancer; was diagnosed with Prurigo or PRN / his left leg in two areas and right leg have Prurigo; experienced atopic dermatitis / did a biopsy showed atopic dermatitis; 5 bumps on both his legs and arms / bump on his belly; itchy welts; itches; he has really rough skin; bumps are crusty; This case was reported by a consumer via call center representative and described the occurrence of skin cancer in a elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 6 months after receiving Shingles vaccine, the patient experienced skin cancer (serious criteria GSK medically significant), prurigo, atopic dermatitis, local swelling, urticaria, pruritus, skin rough and crust. The patient was treated with topical steroid nos (Steroid Cream) and antibiotics nos (Oral Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the skin cancer, prurigo, atopic dermatitis, local swelling, urticaria, pruritus, skin rough and crust were unknown. It was unknown if the reporter considered the skin cancer, prurigo, atopic dermatitis, local swelling, urticaria, pruritus, skin rough and crust to be related to Shingles vaccine. Additional details were provided as follows: The patient reported for himself. The age at vaccination was not reported but could be 79 or 80 years. Between July to November 2020, the patient received 1st dose of Shingles vaccine and a week after the vaccination, the patient experienced atopic dermatitis and was diagnosed with Prurigo or PRN. The patient could not 100 percent confirm that he received the Shingrix because he did not have the lot number, but he believed that it was not Zostavax because his vaccine required 2 doses. The patient claimed that he had 5 bumps on both his legs and arms that were itchy welts and bump on his belly. From last year patient had skin cancer, they did a biopsy on his legs and it showed squamous cancer and atopic dermatitis and it keeps getting worse. The patient stated that when they did the biopsy, his left leg in two areas had cancer and Prurigo but his right leg did not show cancer, but it did have Prurigo. The patient claimed that the condition spreads as he itches it and he had really rough skin. The patient was given steroid cream but that did not help him, so he took an oral antibiotic from a previous diagnosis. The patient reported that his bumps are crusty. The patient reported that he was scheduled to get the 2nd dose on 15th January 2021. The reporter consented to follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,OTH,,Rheumatoid arthritis,,,,"['Biopsy skin abnormal', 'Dermatitis atopic', 'Dry skin', 'Prurigo', 'Pruritus', 'Scab', 'Skin cancer', 'Squamous cell carcinoma', 'Swelling', 'Urticaria']",1,UNKNOWN MANUFACTURER, 952301,CA,19.0,M,"Jan 11-vaccination day. On Jan 14, in afternoon had tinnitus and muffled hearing that went away. The next morning Jan15, complete sudden hearing loss on left ear. Tinnitus and muffled hearing that has not went away.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/11/2021,01/15/2021,4.0,PUB,Vitamin C,"None (Not an illness, but was on Keto diet over a month ago)",None,,None,"['Computerised tomogram normal', 'Deafness', 'Deafness unilateral', 'Hypoacusis', 'Sudden hearing loss', 'Tinnitus']",1,MODERNA,IM 952318,MD,49.0,F,"Patient experienced abdominal pain on January 12th. She reported having a headache and joint pain as well. Her temperature was 103.5. On January 14th the patient was admitted for acute appendicitis with perforation, localized peritonitis, and gangrene. Patient was discharged on January 16th post appendectomy.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/11/2021,01/12/2021,1.0,WRK,,,,,none,"['Abdominal pain', 'Alanine aminotransferase increased', 'Appendicectomy', 'Appendicitis', 'Appendicitis perforated', 'Arthralgia', 'Aspartate aminotransferase increased', 'Body temperature increased', 'Complicated appendicitis', 'Focal peritonitis', 'Headache', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 952328,MA,40.0,F,Patient received Moderna Covid vaccine on Friday evening 1/8/21. She awoke Saturday am around 2AM with a severe headache. She also developed a fever during the day. She did not seek treatment until Sunday and went to Hospital ED. She was treated and released same day. She went back to hospital on Monday as she felt worse and she was admitted at that time and treated for a bloodstream infection and meningitis. We are not sure it was caused by the vaccine. She consulted her PCP and her PCP feels it may be more coincidental given her medical HX.,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,,cystic fibrosis and spleenectomy,,,"['Headache', 'Meningitis', 'Pyrexia', 'Sepsis']",1,MODERNA,IM 952331,TX,56.0,F,A few days after the vaccine I began to have a cough about mid morning which changed to SOB. Covid test on 12/27 which was neg. I went to work on 12/28 but woke up 12/29 with a low grade fever and felt like my throat was on fire. so on the 29th I went and got a Strep and flu test which were negative. I was feeling so bad so on the 6th of Jan do I went to the stand alone ER and got a chest xray and CT scan which revealed I did have pnemonia. I went back home but was feeling worse and was taken to and admitted in hospital for 2 days. Initially I was admitted into the COVID unit but never was diagnosed COVID positive so I was moved off the COVID unit. I was given albuterol pills to try to help with the symptoms but didnt work causing me to have to be admitted and was given several doses of steorid and other antibioics and had to use O2 at night because my stats kept falling.,Not Reported,,Not Reported,Yes,2.0,Not Reported,U,12/22/2020,12/26/2020,4.0,PVT,"Synthroid, Zanaflex, olmesartan medoxomil, Hydrochlorothiazide, Ambien, Venlafaxine, Pravasatin, Hydrocodone",no,"Chronic pain, Hypertension, Hosimitos Disease",,"Lisinopril, Immatrex","['Antibody test negative', 'Chest X-ray abnormal', 'Computerised tomogram thorax abnormal', 'Cough', 'Dyspnoea', 'Feeling abnormal', 'Influenza virus test negative', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test negative', 'Streptococcus test negative', 'Throat irritation']",1,PFIZER\BIONTECH,IM 952371,IN,80.0,F,Patient reported to the emergency room from fever and shortness of breath the day after receiving the COVID-19 vaccine. Patient was found to have a UTI and possible sepsis. Unknown if truly related to COVID vaccine.,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/16/2021,01/17/2021,1.0,UNK,"Aspirin 81mg daily, Pulmicort nebulization BID, calcium/magnesium/zinc daily, candesartan 16mg daily, colecalciferol 2000 units daily, B12 250 mcg daily, digoxin 125 mcg daily, flonase, gemfibrozil 600mg BID, hydrochlorothiazide 12.5mg dail",UTI,"COPD, Hyperlipidemia, hypertension, Type 2 diabetes",,Hydrocodone - GI intolerance,"['Dyspnoea', 'Pyrexia', 'Urinary tract infection', 'White blood cell count increased']",UNK,MODERNA,SYR 952469,MI,57.0,F,"Severe fatigue, Headache frontal and temporal, dizziness/vertigo, tinnitus,",Not Reported,,Not Reported,Not Reported,,Yes,N,01/06/2021,01/06/2021,0.0,PVT,"Estradiol, Levsin, Omeprazole, Zoloft, Topical Retin-A, Ventolin PRN","COVID IN March 2020, resolved and had a second flare a week after symptoms improved.","IBS, GERD, Depression, Asthma well controlled, menopause",,PCN-anaphylaxis sulfa-rash,"['Blood folate', 'Blood thyroid stimulating hormone', 'Dizziness', 'Epstein-Barr virus antibody', 'Fatigue', 'Full blood count', 'Headache', 'Metabolic function test', 'Red blood cell sedimentation rate', 'Tinnitus', 'Vertigo', 'Vitamin B12']",UNK,MODERNA, 952478,NH,33.0,F,"Pt is 33 yo female with h/o multiple drug allergies , including allergy to benadryl. She has received first dose of COVID vaccine made by Phfizer at 3:45. She reports about 10 minutes after the vaccination she started feeling tingling in her lips, throat and prickly sensation on her chest and feeling ""off"". Felt dizzy, developed small hives on her chest. She was attended to immediately at the vaccine site and our team was called to white code. Pt was sitting on the floor, alert , breathing comfortably. Her BP was 151/84, HR 90, O2 Sats 100%. Her lungs were clear the whole time, no wheezing, no difficulty swallowing or talking. Patient received 125 mg of IV solumedrol and 20 mg of pepcid in vaccination room, she felt the same, still breathing comfotably, speaking full sentences, hives faiding away. She was transported to Urgent Care clinic on wheelchair. Pt kept her EpiPen by her site the whole time but refused to used it, states she is afraid to use it and wants to hold off or get it in ER if necessary. About 16:30 patient reported her tingling, prickly sensation In her chest is getting worse, developed sensation of lump in her throat, able to swallow and breath without problems, lungs exam clear. Again recommended to give Epipen but patient again refused as she feels very anxious about getting new medicine. She was able to speak full sentences and breathing well, O2 Sats 100% the whole time, she repetitively refused EpiPen. EMS called and patient transported to ER, ER notified. Pt left in stable condition.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,OTH,DIETARY SUPPLEMENT ORAL LACTOBACILLUS ACIDOPHILUS (PROBIOTIC ORAL) cetirizine (ZYRTEC) 10 mg tablet ranitidine (ZANTAC) 150 mg tablet epiNEPHrine (EPIPEN) 0.3 mg/0.3 mL injection,Dairy product intolerance Mast cell disorder Granuloma annulare Goiter,Dairy product intolerance Mast cell disorder Granuloma annulare Goiter,,"Bactrim [Sulfamethoxazole-trimethoprim]Anaphylaxis, Hives CiprofloxacinAnaphylaxis MorphineAnaphylaxis Reglan [Metoclopramide Hcl]Hives Sulfa (Sulfonamide Antibiotics)Hives Benadryl [Diphenhydramine Hcl]Rash DoxycyclineNausea And Vomiting Lactose Nasonex [Mometasone]Other (See Comments) Tape 1""x5yd [Adhesive Tape]Rash Toradol [Ketorolac Tromethamine]Hives","['Anxiety', 'Dizziness', 'Feeling abnormal', 'Paraesthesia', 'Paraesthesia oral', 'Pharyngeal paraesthesia', 'Sensation of foreign body', 'Urticaria']",UNK,PFIZER\BIONTECH, 952483,SC,59.0,F,"On 01/13/2021 at about 11pm I began having pain in both arms and across my chest. Also nausea and vomiting. At midnight I went to the Emergency room and was diagnosed with a heart attack, underwent emergency catheterization and stent placement. I had complete occlusion of the right coronary artery",Not Reported,,Yes,Yes,3.0,Not Reported,U,01/11/2021,01/13/2021,2.0,PVT,Synthroid 100mcg/day lisinopril 10mg/day pravachol hydroxychloroquin 200mg twice a week Zinc 5mg/day Vit D 6000iu/day VitC,HTN Hypothyroid hyperlipidemia,see above Breast Cancer 1993,,cipro,"['Acute myocardial infarction', 'Catheterisation cardiac abnormal', 'Chest X-ray', 'Chest pain', 'Coronary arterial stent insertion', 'Coronary artery occlusion', 'Diastolic dysfunction', 'Echocardiogram abnormal', 'Ejection fraction decreased', 'Electrocardiogram abnormal', 'Myocardial infarction', 'Nausea', 'Pain in extremity', 'Vomiting']",1,PFIZER\BIONTECH,IM 952489,MI,39.0,M,"Patient is 39-year-old male with no significant past medical history who works at long-term care facility. He received COVID-19 vaccine on 1/13/2021 and immediately developed numbness and tingling in the area of injection which was the left shoulder. Over the next 15 to 30 minutes numbness and tingling expanded to the left side of his body including face arm and leg and the left side of his trunk. He began to feel foggy and had some slurred speech. He presented to the Emergency Room and tests were performed to rule out a stroke. The patient denies any other symptoms such as fever chills myalgias. He did not have any weakness of the extremities. He did not have any speech disturbances or visual disturbances. This morning on examination he states his symptoms are much better. He still has some residual numbness in his leg and arm. Facial numbness is almost all gone. As of 1/18/2021, residual numbness and tingling is only in his left ring and pinky finger.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/13/2021,01/13/2021,0.0,PVT,Currently not taking any medications.,,,,Hives from Levofloxacin,"['Computerised tomogram head normal', 'Dysarthria', 'Feeling abnormal', 'Hypoaesthesia', 'Immediate post-injection reaction', 'Injection site hypoaesthesia', 'Injection site paraesthesia', 'Magnetic resonance imaging brain normal', 'Paraesthesia', 'Scan with contrast normal']",1,MODERNA,IM 952497,IL,40.0,M,"Patient with PMH of depression and GERD who presented 1/8 with constipation, abdominal discomfort and worsening dyspnea. Symptoms began around 12/29. COVID vaccine 12/19. Previously quite active, marathon runner, gained some weight over last couple years but was still in good enough shape to complete 10K in New Orleans in early February. In late February, had a flu-like illness, as did one of his friends from church. 2020 was hard on him - weight gain, decreased activity, stress, overall deconditioning. No issues apart from sore arm after COVID vaccine 12/19 but then starting getting abdominal fullness/discomfort around 12/29, which steadily worsened, also develop worsening dyspnea on slight exertion. No known sick contacts.. Work-up notable for pericardial effusion, pleural effusions. Echo with severe diffuse LV hypokinesis, concern raised for myocarditis. COVID PCR negative, serology negative. RVP negative. . Concern raised that COVID vaccine may have played a role in myocarditis. He was found to have the following conditions Acute heart failure with reduced EF NYHA FC II, non-ischemic cardiomyopathy. Myocarditis appears subacute per MRI hypertension obesity small pericardial effusion- asysmptomatic no pericarditis suspected obstructive sleep apnea. .Started on the following medications. Continue Carvedilol 12.5mg BID, Farxiga 5mg daily, Digoxin 0.125mg daily, Entresto 97-103mg BID, and Spironolactone 25mg daily. Per MD note. While it remains uncertain, team is doubtful COVID vaccine played a role in his cardiac issues. Given the MRI findings are not acute, more likely that the cardiac insult occurred weeks to months ago - potentially in the setting of the February 2020 illness. Perhaps his ""deconditioning"" in 2020 was related to worsening cardiac function. Nevertheless, will hold on 2nd COVID vaccine dose given absence of a clear explanation for his myocarditis. conversation with team will continue to determine if candidate for second covid vaccine. If consensus is that myocarditis pre-dated vaccine, might be able to proceed with dose 2 of vaccine.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,12/19/2020,01/08/2021,20.0,PVT,Nexium 20mg po daily Duloxetine 60mg po daily Ibuprofen as needed Vitamin D,,none,,NKDA,"['Abdominal discomfort', 'Abdominal distension', 'Cardiac failure', 'Cardiomegaly', 'Cardiomyopathy', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram thorax abnormal', 'Constipation', 'Cytomegalovirus test', 'Cytomegalovirus test negative', 'Dyspnoea', 'Dyspnoea exertional', 'Echocardiogram abnormal', 'Ejection fraction decreased', 'Epstein-Barr virus antibody negative', 'Hepatitis viral test negative', 'Hilar lymphadenopathy', 'Hypertension', 'Left ventricular dysfunction', 'Lymphadenopathy mediastinal', 'Magnetic resonance imaging heart', 'Myocarditis', 'Obesity', 'Pain in extremity', 'Pericardial effusion', 'Pleural effusion', 'Pulmonary oedema', 'Respiratory viral panel', 'Right ventricular ejection fraction decreased', 'SARS-CoV-2 antibody test negative', 'SARS-CoV-2 test negative', 'Sleep apnoea syndrome', 'Ventricular hypokinesia']",1,PFIZER\BIONTECH,IM 952515,TX,,M,"Sore throat with excessive saliva / diagnosed with Epiglottitis; excessive saliva; Tuesday had a sore throat / received IM anti-biotic / Thursday still had a very bad sore throat; This case was reported by a nurse via sales rep and described the occurrence of epiglottitis in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. In May 2019, the patient received the 1st dose of Shingrix .5 ml. In May 2019, 1 day after receiving Shingrix, the patient experienced sore throat. On an unknown date, the patient experienced epiglottitis (serious criteria hospitalization and GSK medically significant) and saliva secretion excessive. The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the epiglottitis, sore throat and saliva secretion excessive were recovered/resolved. It was unknown if the reporter considered the epiglottitis, sore throat and saliva secretion excessive to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix .5ml dose on a Monday around May 2019. The next day on Tuesday, this patient had a sore throat, on Wednesday he received an IM anti-biotic, on Thursday still had a very bad sore throat with excessive saliva so went to hospital and diagnosed with Epiglottitis. This patient's condition eventually resolved with no further issues. The patient never received a second Shingrix immunization. Supposedly this patient did experience a case of Shingles the year before he received the Shingrix vaccine. This nurse wanted to know if the patient could receive a COVID vaccine. The reporter did not know if there was any causal relationship with the vaccine so she never reported.",Not Reported,,Not Reported,Yes,,Not Reported,Y,05/01/2019,05/01/2019,0.0,UNK,,,Medical History/Concurrent Conditions: Shingles,,,"['Epiglottitis', 'Oropharyngeal pain', 'Salivary hypersecretion']",1,GLAXOSMITHKLINE BIOLOGICALS, 952518,NJ,60.0,F,"diagnosed with breast cancer / right breast / 2 cm. in size; received the injection / hurt / as being bit by a Jersey mosquito; This case was reported by a consumer via call center representative and described the occurrence of breast cancer in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 1st December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced breast cancer (serious criteria GSK medically significant) and injection site pain. On an unknown date, the outcome of the breast cancer and injection site pain were unknown. It was unknown if the reporter considered the breast cancer and injection site pain to be related to Shingrix. Additional details were provided as follows: The patient reported that she received her first dose of Shingrix and she was diagnosed with breast cancer around the same time. The patient could not recall the exact date of her diagnosis and she couldn't confirm if the diagnosis occurred before or after the vaccination. The patient claimed that the breast cancer was in her right breast and was 2 cm. in size. The patient planned to undergo chemotherapy. She also reported that when she received the injection, it hurt which she described as being bit by a mosquito. The reporter consented to follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,,,UNK,,,,,,"['Breast cancer female', 'Injection site pain']",1,GLAXOSMITHKLINE BIOLOGICALS, 952523,,,M,"Vascular dementia; Had a reaction; This spontaneous case was received on 06-Jan-2021 from a pharmacist via Health Authority (reference number: SEQW21-00057) with additional information received on the same date (reference number: SEQW21-00058) (being processed together) and concerned an elderly, male patient. At the time of this report, the patient was an 84-year-old. The patient's medical history and concomitant medications were not reported. On an unknown date in 2018, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration and anatomical location: not reported) for flu prophylaxis. The batch number was not reported. On an unspecified date in 2018, unknown amount of time after receiving Fluad (TIV), the patient had a reaction at that point, but the reporter did not know what kind of reaction. On an unknown date, the patient was diagnosed with vascular dementia that got worse and was now in a nursing home. The reporter did not provide causality assessment. The reporter stated patient was diagnosed with vascular dementia, but they were not sure if this was related to the vaccine. At the time of initial reporting on 06-Jan-2021, the patient had not recovered from the event of vascular dementia. The outcome of event 'adverse reaction' was not reported. The event of vascular dementia was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department. Company comment: A 84-year-old male patient experienced adverse reaction unknown amount of time after administration of Fluad (TIV). Vascular dementia was diagnosed on an unknown date. The patient's medical history and concomitant medications were not reported. Causality is unassessable for both events due to low narrative data.; Reporter's Comments: The reporter stated patient was diagnosed with dementia, but they were not sure if this was related to the vaccine.; Sender's Comments: A 84-year-old male patient experienced adverse reaction unknown amount of time after administration of Fluad (TIV). Vascular dementia was diagnosed on an unknown date. The patient's medical history and concomitant medications were not reported. Causality is unassessable for both events due to low narrative data.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Comments: None,,,"['Adverse reaction', 'Vascular dementia']",UNK,NOVARTIS VACCINES AND DIAGNOSTICS,OT 952524,AZ,75.0,F,"Blood pressure: 219/173, 186/97; Don't feel well- palpitation, cold and hurt around neck; Don't feel well- palpitation, cold and hurt around neck; Don't feel well- palpitation, cold and hurt around neck; Swelling 2r:1 inch right a way as the needle out; Don't feel well- palpitation, cold and hurt around neck; This spontaneous case was retrieved on 06-Jan-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 900434-1), reported by other health professional and concerned a 75-year-old female patient. The patient's concurrent conditions included hypertension, hypercholesterolemia, osteoporosis. The patient's concomitant medications were not reported. On 24-Oct-2020, the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose reported as one, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 279820. On the same day, after receiving Fluad Quadrivalent, the patient developed swelling '2r' (as reported):1 inch, right away as the needle was out. After around 10 minutes, the patient did not feel well, had palpitation, was cold and hurt around the neck. Pharmacist gave two tablets of Benadryl (diphenhydramine hydrochloride) at dose of 25 mg by mouth. The blood pressure was monitored: 219/173 - 70 and five minutes after 186/97 - 70 (units were not reported). The patient asked to call 911. No further details were provided. On an unspecified date in 2020, the patient recovered from all events. The reporter did not provide a causality assessment. The event of 'hypertension' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department. Company comment: A 75-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient developed hypertension, palpitations, swelling, neck pain, malaise, vaccination site swelling and feeling cold. The patient's concurrent conditions included hypertension, hypercholesterolemia, osteoporosis. Causality was highly confounded for hypertension and palpitations, cannot be totally excluded due to plausible chronology. Causal role of the suspect vaccine is unassessable for hypertension and palpitations, due to lack of information regarding concomitant medications and treatment compliance. Causal role of the suspect vaccine is assessed as possibly related for swelling, neck pain, malaise, vaccination site swelling and feeling cold.; Sender's Comments: A 75-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient developed hypertension, palpitations, swelling, neck pain, malaise, vaccination site swelling and feeling cold. The patient's concurrent conditions included hypertension, hypercholesterolemia, osteoporosis. Causality was highly confounded for hypertension and palpitations, cannot be totally excluded due to plausible chronology. Causal role of the suspect vaccine is unassessable for hypertension and palpitations, due to lack of information regarding concomitant medications and treatment compliance. Causal role of the suspect vaccine is assessed as possibly related for swelling, neck pain, malaise, vaccination site swelling and feeling cold.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,10/24/2020,10/24/2020,0.0,PHM,,Hypercholesterolemia; Hypertension; Osteoporosis,,,,"['Condition aggravated', 'Feeling cold', 'Hypertension', 'Injection site swelling', 'Malaise', 'Neck pain', 'Palpitations']",UNK,"SEQIRUS, INC.",OT 952653,IA,65.0,F,"PATIENT RECEIVED VACCINE 1/7/21 AT 1000. THE NEXT DAY, PATIENT PRESENTS TO ER ON 1/13/21 WITH COMPLAINTS OF PALPITATIONS AND DIZZINESS OCCURING SINCE HER FIRST DOSE OF VACCINE. ""The patient states she has had these episodes for the last 6 days and they started when she got her COVID vaccine. The patient states she has had numerous episodes over the last 6 days of this that lasts between 2 and 4 hours. The patient can feel her heart fluttering and she gets a little dizzy with it. The patient has not had any nausea, shortness of breath or chest pain with these episodes however. The patient has not had any prior episodes of this. The patient takes no regular medications apart from vitamins."" PATIENT WAS DIAGNOSED WITH NEW FOUND A. FIB WITH RVR. ADMITTED TO HOSPITAL FOR OBSERVATION. PATIENT RETURNED TO NORMAL SINUS RHYTHM THE NEXT DAY AFTER INITIATING DILTIAZEM AND ELIQUIS.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/07/2021,01/13/2021,6.0,PVT,,,,,,"['Atrial fibrillation', 'Cardiac flutter', 'Dizziness', 'Palpitations']",1,MODERNA,IM 952671,IA,39.0,F,"EDD July 4, 2021 January 15th baby no longer had a heartbeat after two previous visits confirming heartbeat and EDD.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/22/2020,01/15/2021,24.0,PVT,Tylenol lovenox Fluoxetine Folate Prenatal MVI magnesium,none,none,,none,"['Exposure during pregnancy', 'Foetal heart rate abnormal', 'Ultrasound antenatal screen', 'Urine analysis']",1,MODERNA,IM 952677,NY,60.0,M,"DVT in right leg 4 days after injection, severe pain in thigh/calf, difficulty walking Placed on Xarelto 15mg 2X daily for 21 days and then 20mg daily for 9 days. Next Doctor visit is 1/26/2021 at 9:00am Next scheduled Covid 19 vaccine is scheduled for 2/5/2021 at 7:15am",Not Reported,,Yes,Not Reported,,Not Reported,N,01/07/2021,01/11/2021,4.0,PVT,Valsartan 160mg daily Alfuzosin 10mg daily Aspirin 81mg daily,None,"High Blood Pressure BPH DVT on June 6, 2016",,None,"['Condition aggravated', 'Deep vein thrombosis', 'Gait disturbance', 'Pain in extremity', 'Ultrasound scan']",1,MODERNA,IM 952689,TN,64.0,F,"After I received the vaccine went home rested temp went up one time 99.0. The next day woke up heart was pounding check my BP 150/80 laid back down. I woke up around 5pm my BP had elevated to 160 (don't remember diastolic reading) pulse rate normal limits. I informed my spouse of what was happening called 911. At the hospital checked vitals, EKG, CT Scan, Chest X-ray, Blood work and Potassium was low took 2 Potassium pills. I went back home on 12/31 returned to work did fine that day. On New Years day everything started back again discomfort went back to ER. I felt like force in my chest the doctor collected my information and I was placed on a low dose BP medication until I return to my PCP, cardiologist(stress test). I followed up with PCP via Telehealth about my BP concerns, my dosage was increased to 25 mg and due to my symptoms I was placed on leave from work 2 wks. I also have a appointment scheduled with Neurologist.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/28/2020,12/29/2020,1.0,PVT,"Estrogen, Vit D, Multivitamin, Elderberry",UTI (one month prior),Arthritis (left knee),,No,"['Blood potassium decreased', 'Blood pressure increased', 'Blood test', 'Chest X-ray', 'Chest discomfort', 'Computerised tomogram', 'Discomfort', 'Electrocardiogram', 'Impaired work ability', 'Palpitations']",1,PFIZER\BIONTECH,IM 952704,OK,79.0,M,"Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home.",Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,OTH,Daughter does not know all medications to list at time of reporting,Pneumonia 12/20 not Covid19 related,"COPD, Curvature of Spine pressed against lung, High blood pressure, Diabetes",,,"['Abdominal pain upper', 'Abnormal behaviour', 'Agitation', 'Anxiety', 'Completed suicide', 'Confusional state', 'Dementia', 'Dyspnoea', 'Panic disorder', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tremor', 'Vaccination complication']",UNK,PFIZER\BIONTECH, 952707,NH,38.0,M,"Anaphylaxis (urticaria, tongue swelling, subjective difficulty breathing) starting approx. 24hrs first moderna dose. No prior episodes of anaphylaxis/allergic rxn. Treated with Benadryl 100mg PO (prior to arrival, pt administered), famotidine 20mg IV, Epinepherine 0.3mg IM. Monitored in ED, complete resolution of symptoms, discharged home.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/14/2021,01/15/2021,1.0,PVT,colchicine,None,Gout,,NKDA,"['Anaphylactic reaction', 'Dyspnoea', 'Swollen tongue', 'Urticaria']",1,MODERNA,IM 952713,MO,64.0,M,"Weakness, Low O2, death. Positive for COVID on 1/12/21, dies on 1/16/21",Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/12/2021,13.0,SEN,,,"Diabetes, Parkinson Disease",,"PCN, Zithromax, Flomax","['Asthenia', 'Death', 'Oxygen saturation decreased', 'SARS-CoV-2 test positive']",UNK,MODERNA,IM 952782,IL,29.0,F,"Patient presented to ED with complaint of chest pain, radiating down left arm, not relieved with Tums. Symptoms started at 0530 1/12/2020. Patient presented to ED b/c of strong family history of CAD, with father having MI in his 50s.",Not Reported,,Yes,Yes,1.0,Not Reported,U,01/09/2021,01/12/2021,3.0,PVT,"MVI, Desvenlafaxine, Desogestrel-Ethinyl Estradiol",,,,,"['Cardiac ventriculogram left normal', 'Catheterisation cardiac normal', 'Chest pain', 'Troponin increased']",UNK,MODERNA, 952799,PA,79.0,M,"On 1/17/2021 at 4:35 am resident found apneic and pulseless, at 4:40am death confirmed",Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/17/2021,12.0,UNK,,,,,,"['Apnoeic attack', 'Death', 'Pulse absent']",1,PFIZER\BIONTECH,IM 952803,FL,47.0,F,"I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my neck and back of my throat which began spreading to the back of my head . My heart felt as if I was startled by something. I looked at my smart watch and my heart rate was 145. I began trembling and having abdominal cramping . The back of my head felt like I had swelling or collection of fluid. I opened my windows and began taking slow deep breaths to bring down my heart rate . It took quite a while to get it below 100. I felt as if I was going to pass out. After deep breathing for what felt like atleasr 15 to 20 minutes , my pulse came down and I closed my windows . As soon as my body warmed back up in the car , the symptoms returned and my heart rate went back up to 130s , 140s . I had to keep my windows down and deep breathe the entire way home which took an hour . My body was trembling. When I got home I felt as if I was too week to get out of the car . I still felt that startled feeling in my heart and was afraid of what could happen next . My lips and face were swollen. My lips were also slightly itchy. I called 911 for help . By the time they arrived my vital signs had stabilized but I still had swelling in my face and lips . My EKG , vital signs and oxygen levels checked out normal so I did not go to the ER. That night I took benadryl and Tylenol. Day 2 post vaccine the collection of fluid or swelling in the back of my head had now spread to the top . That night I had the feeling that my throat was swelling do I took benadryl and Tylenol and my face and lips were still slightly swollen . Day 3 post vaccine I woke up with slightly blurry vision. The swelling in my head now feels like it has encompassed my entire head and have a slight headache. I went to the urgent care requesting an MRI of the head and an epi pen . I was given Medrol dose pack , an RX for epi pen for emergencies and advised to continue benadryl and Tylenol. Day 4 post vaccine, slight headache continues. Slightly blurry vision",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,PVT,None,None,None,,None,"['Abdominal pain', 'Asthenia', 'Dizziness', 'Electrocardiogram normal', 'Feeling cold', 'Headache', 'Heart rate increased', 'Lip pruritus', 'Lip swelling', 'Pharyngeal swelling', 'Swelling', 'Swelling face', 'Tremor', 'Vision blurred']",1,PFIZER\BIONTECH,IM 952852,NJ,37.0,M,"12/29/2020 Vaccination. Within minutes blurry vision, dizzy, tx to stretcher. EXTREME HA, coughing, sensitivity to light. EPI pen in ER. I fell asleep. Woke up, don't remember much. Admitted to hospital. Chest pains started within 2 hours, SOB, HA. Admitted for 2 nights, 3 days. Discharged home. Still having SOB and referred to Pulmonologist. Waiting on appt. *did NOT have problems before this vaccine. I was fine. Now i am completely different person, I have to monitor my walking, etc.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,,,,,,"['Chest X-ray normal', 'Chest pain', 'Cough', 'Dizziness', 'Dyspnoea', 'Electrocardiogram normal', 'Full blood count normal', 'Headache', 'Metabolic function test normal', 'Photophobia', 'SARS-CoV-2 test negative', 'Vision blurred']",1,MODERNA,SYR 952872,IL,80.0,M,"80YO male who htn, cva, epilepsy, ckd, cerebral avm s/p repair, cad s/p cab, cva (left sided hemiplegia) , hx of prostate cancer recent admission for pna on abx presents to ED on 1/11 with dizziness, hypoxia. CT with Bilateral PE ""Large bilateral pulmonary artery emboli in the right and left main pulmonary artery extending into the right and left main pulmonary artery branches bilaterally. Findings are associated with right-sided heart strain."" ""Patchy alveolar airspace disease within the lungs highly suspicious for COVID pneumonia"" Covid negative. Patients wife recovered from Covid-19 infection within last month. Patent thus far has tested negative. Doppler lower extremity revealed Acute occlusive vein thrombosis of the entire course of the gastrocnemius vein and soleal vein. Patient received covid vaccine on 1/4/21. Patient has several risk factors for clot - age, previous CVA, hx of prostate cancer. Also had positive covid exposure though tested negative",Not Reported,,Not Reported,Yes,8.0,Not Reported,N,01/04/2021,01/11/2021,7.0,SEN,aspirin 81mg daily Vitamin B-1 100mg daily Escitalopram 20mg daily gabapentin 100mg daily Levetiracetam 1000mg BID and 500mg qhs Pantoprazole 20mg daily Phenytoin 250mg qhs rosuvastatin 20mg daily Tamsulosin 0.4mg daily MVI daily Vitamin,pneumonia treated with vantin (1/10),"hx of HTN, epilepsy, CKD, cerebral AVM s/p repair, CAD, CVA (left sided hemiplegia), ischemic heart disease s/p CABG",,nsaids -patient reports contribute to seizures,"['Alveolar lung disease', 'Aortic arteriosclerosis', 'Aortic valve incompetence', 'Atelectasis', 'Cardiac failure', 'Cardiomegaly', 'Chest X-ray abnormal', 'Computerised tomogram thorax abnormal', 'Deep vein thrombosis', 'Dizziness', 'Echocardiogram abnormal', 'Fluid overload', 'Hypoxia', 'Left ventricular hypertrophy', 'Lung consolidation', 'Myocardial strain', 'Pleural effusion', 'Pulmonary embolism', 'Pulmonary hypertension', 'Right atrial dilatation', 'Right ventricular dysfunction', 'Right ventricular hypertrophy', 'Right ventricular systolic pressure decreased', 'SARS-CoV-2 test negative', 'Tricuspid valve incompetence', 'Ultrasound Doppler abnormal']",1,PFIZER\BIONTECH,IM 952881,MO,89.0,M,"Resident was seen by MD on 1/11/2021 due to increasing in edema and shortness of breath. Lasix 40 mg STAT given. New orders to get a STAT CBC, CMP, and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on 11/23/2020. Labs were abnormal. Continued on the lasix 40 mgs. Resident remained short of breath with exertion and on oxygen. He was assisted to the toilet on 1/15/2021 in the morning where he subsequently passed away.",Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/11/2021,1.0,SEN,"Lasix, Timolol Maleate, Benefiber, Pravastatin, Multivitamin, Carbidopa ER 50-Levodopa 200 daily; Carbidopa ER 50-Levodopa 200 2 tabs daily, I-vite, Lactobacillus; Metoprolol Succinate; Tamsulosin, Finasteride, Oxubytynin","Edema, Hypokalemia, Hypertensive heart with heart failure","Parkinson's Disease; COPD; Heart failure unspecified; Old myocardial infarction, Overactive bladder, Hyperlipidemia, Adult Failure to thrive, Urinary retention, Constipation unspecified, Unspecified urinary incontinence, Benign prostatic hyperplasia, other seasonal allergies rhinitis, unspecified glaucoma, mild cognitive impairment, Pressure ulcer of right heel, history of falling, dependence in wheelchair, COVID-19 on 11/23/2020",,No known allergies,"['Alanine aminotransferase normal', 'Blood albumin decreased', 'Blood chloride decreased', 'Blood potassium normal', 'Blood sodium decreased', 'Blood urea normal', 'Brain natriuretic peptide increased', 'Carbon dioxide increased', 'Death', 'Dyspnoea', 'Glomerular filtration rate', 'Haematocrit decreased', 'Haemoglobin decreased', 'Lymphocyte count decreased', 'Mean cell haemoglobin concentration decreased', 'Mean cell haemoglobin decreased', 'Neutrophil count normal', 'Oedema', 'Red blood cell count decreased', 'Red cell distribution width increased']",1,MODERNA,IM 953064,PA,,F,"hives on her face; This is a spontaneous report from a contactable healthcare professional (physician assistant). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), via an unspecified route of administration, on 24Dec2020 as a single dose (reported as 0.3) for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient experienced hives on her face in Dec2020, which was reported as medically significant. It was reported that within 24 hours of vaccination, the patient had hives for 48 hours. The event was reported as a moderate systemic reaction. The clinical outcome of hives on her face was recovered in Dec2020.; Sender's Comments: Based on the compatible time association, the event hives on her face is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/01/2020,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Hypersensitivity', 'Urticaria']",1,PFIZER\BIONTECH, 953065,MN,29.0,F,"a low grade fever; cough; doesn't feel very well; feeling yucky; soreness in the arm where vaccine was given; This is a spontaneous report from a contactable Nurse (reporting for herself). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, bacth/lot no: EK9231 while expiry date was unknown), intramuscular on left deltoid on 07Jan2021 16:45 at a single dose for covid-19 immunization. There were no medical history and concomitant medications reported. Patient has no prior vaccination within 4 weeks.The patient got her first dose of the COVID 19 vaccine yesterday (07Jan2021) from her employer. She started ""feeling yucky"" today (08Jan2021) around noon with a low grade fever,and developed a cough that was not persistent. Patient has soreness in the arm where vaccine was given. She was asking what should she do about it? Outcome of the events low grade fever, cough, feeling unwell, feeling abnormal were not recovered while vaccination site pain was unknown. The events low grade fever, cough, feeling unwell were considered serious medically significant and related to vaccine.; Sender's Comments: Based on the time association, the events fever, cough and malaise are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Cough', 'Feeling abnormal', 'Injection site pain', 'Malaise', 'Pyrexia']",1,PFIZER\BIONTECH,OT 953067,CA,34.0,F,"generalized weakness; flushing; my BP is high; dose 1 start date 19Dec2020; dose 2 start date 8Jan2021; This is a spontaneous report from a contactable pharmacist. A 34-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), intramuscular in left arm on 08Jan2021 at a single dose for COVID-19 immunization. Medical history included chronic HTN and allergies to baclofen and statins. The patient's concomitant medications were unspecified medications taken for hypertension. The patient previously received the first dose of bnt162b2 on 19Dec2020 via intramuscular in left arm, lot EL0140. On 08Jan2021, the patient was brought into ER as code MET. Patient was receiving her second vaccine for COVID-19 when she experienced generalized weakness and flushing. She stated that she knew her BP was high. Endorses hx chronic HTN, reports she took all three medications this AM. The patient denied any headache, new visual change, CP, SOB, or focal weakness. The events recovered on an unknown date in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the events.; Sender's Comments: Based on the time association, the events asthenia, flushing and hypertension are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Drug allergy; Hypertension (Endorses hx chronic HTN),,,"['Asthenia', 'Blood pressure increased', 'Flushing']",2,PFIZER\BIONTECH,OT 953069,GA,55.0,F,"Profuse watery vaginal bleeding 12 hrs after injection. Bleeding lasted approximately six hours. After first injection and vaginal bleeding, gynecology exam completed for abnormalities; This is a spontaneous report from a contactable physician (patient). A 55-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), intramuscular in the left arm on 22Dec2020 at 16:00 at a single dose; and the second dose via intramuscular in the left arm on 08Jan2021 at 08:00 at a single dose as COVID-19 vaccine. Medical history included a known latex allergy and previous spontaneous cerebral artery dissection x 3 ( nonspecific connective tissue disease). The patient was not pregnant at the time of vaccination and did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. Concomitant medications (reported as other medications within two weeks of vaccination) included estrogens conjugated (PREMARIN), micronized progesterone, colecalciferol (Vitamin D), folic acid (FOLATE), and diphenhydramine hydrochloride (BENADRYL). On 23Dec2020, the patient experienced profuse watery vaginal bleeding 12 hours after the injection. The bleeding lasted approximately six hours. After the first injection and vaginal bleeding, a gynecology exam was completed for abnormalities. Previously diagnosed uterine fibroids present and some free fluid in the pelvis by ultrasound. Bleeding resolved by the end of post-vaccine day 1. After the second vaccine, heavy vaginal bleeding started 10 hours after a injection. It was reported that the adverse event result in a doctor or other healthcare professional office/clinic visit. Treatment for the event involved removal of the IUD. Outcome of the event was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect). Information about the lot/batch number has been requested.; Sender's Comments: There is reasonable possibility that the event vaginal hemorrhage is related to suspect drug BNT162B2 based on a compatible temporal relation between vaccination and the onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,PREMARIN; ; VITAMIN D [COLECALCIFEROL]; FOLATE; BENADRYL,,Medical History/Concurrent Conditions: Artery dissection; Latex allergy; Uterine fibroids,,,"['Intra-uterine contraceptive device removal', 'Pelvic fluid collection', 'Ultrasound pelvis abnormal', 'Vaginal haemorrhage']",1,PFIZER\BIONTECH,OT 953070,IL,36.0,F,"few enlarged and abnormal lymph nodes believed to be reactive in nature; patient was pregnant at the time of vaccination; large mass appeared in right axilla; mass was painful to touch; large mass appeared in right axilla; mass was painful to touch; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received the first dose of bnt162b2 (COVID 19, brand: Pfizer) lot no: EJ1685, via an unspecified route of administration in right arm on 23Dec2020 07:15 at a single dose for COVID-19 immunization in a hospital. The patient had no relevant medical history and no known allergies. The patient was pregnant at the time of vaccination, last menstrual date was on 05Oct2020, delivery date will be on 12Jun2021, gestation period: 11. Concomitant medication includes daily multivitamin. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. On 30Dec2020 04:00 am, 7 days after vaccine (as reported), a large mass appeared in right axilla. The mass was painful to touch. Overnight mass more than doubled in size on 31Dec2020 the mass took up her entire arm pit, went to immediate care and was given antibiotics. The mass decreased in size but has not gone away. She followed up with primary care. She had bloodwork and ultrasound of axilla and right breast. Blood work was normal. Ultrasound showed a few enlarged and abnormal lymph nodes believed to be reactive in nature. Largest lymph node as of 08Dec2020 2.5 x 0.9 x 2.2 cm. The events were reported as non-serious. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/30/2020,7.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Axillary mass', 'Blood test normal', 'Exposure during pregnancy', 'Lymphadenopathy', 'Tenderness', 'Ultrasound breast abnormal', 'Ultrasound scan abnormal']",1,PFIZER\BIONTECH, 953072,RI,29.0,F,"Syncopal event; Nausea; Vomiting; This is a spontaneous report from a contactable nurse. A 29-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1284), via an unspecified route of administration on the right arm on 08Jan2021 12:15 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included influenza vaccine (INFLUENZA VACCINE) on 13Dec2020. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 18Dec2021 12:15. The patient experienced syncopal event, nausea and vomiting on 09Jan2021 05:00. The patient received no treatment. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible time association, the event syncope is possibly related to suspect drug BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Inappropriate schedule of product administration', 'Nausea', 'Syncope', 'Vomiting']",2,PFIZER\BIONTECH, 953074,AL,33.0,F,"allergic reaction; large red itchy rash on her neck / chest area; trembling; This is a spontaneous report from a contactable pharmacist. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration (lot number: EL1283) in the arm right on 07Jan2021 09:00; at single doses for COVID-19 immunization. Medical history included known allergies: latex. Concomitant medications included magnesium oxide (MAG OXIDE) at 200 mg, daily (every day) and cetirizine hydrochloride (ZYRTEC) at 10 mg, daily (every day); and toprolol at 25 mg, every day (pending clarification for the drug). The patient previously received first dose of BNT162B2 on 17Dec2020 (lot number: EK5730) for COVID-19 immunization. Patient was not diagnosed with COVID-19 prior to vaccination; and has not been tested for COVID-19 since vaccination. Within the 15-minute observation period on 07Jan2021, the patient developed a large red itchy rash on her neck and chest area; she stated she felt fine but was observed trembling. She was transported to ED (emergency department, 5 min transport). She was treated with diphenhydramine hydrochloride (BENADRYL) at 25mg IV X1 (intravenous), and methylprednisolone (SOLUMEDROL) at 60mg IV X1 and famotidine 20mg IV X 1. Patient diagnosis was allergic reaction on 07Jan2021. Patient improved after treatment and was discharged (after being in Emergency room/department or urgent care) as she was observed from 09:11 until 10:33. Final outcome of the events was all recovered on unspecified date.; Sender's Comments: Based on the time association, the allergic reaction, rash erythematous and trembling are possibly related to suspect BNT62B2 administration.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,MAG OXIDE; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Latex allergy,,,"['Hypersensitivity', 'Rash', 'Rash erythematous', 'Rash pruritic', 'Tremor']",2,PFIZER\BIONTECH, 953077,IL,42.0,F,"couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind eyes/eyes hurt; icreamed; Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off; Whole body still weak; sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips; Twitching of face when do certain movements; brain zaps and brain buzzing began; numbness to right side of face to neck/made its way to left side; Horrible headache; fatigue; felt pressure behind her right eye; felt in a fog; forgetful mid conversation; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, EL0140), intramuscular on 23Dec2020 08:00 at single dose at right arm for COVID-19 immunization; prednisone via an unspecified route of administration from an unspecified date to an unspecified date (for 4 days) at 50 mg for an unspecified indication. Medical history included Known allergis: latex, contrast dye. Concomitant medication included the first dose of influenza vaccine (FLU) on 30Nov2020 at single dose at right arm for immunization. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient received other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Day 1: on 23Dec2020 08:15, the patient felt pressure behind her right eye after shot, felt in a fog, forgetful mid conversation. Day 2. (24Dec2020) Horrible headache started, fatigue. Day 3 (25Dec2020) brain zaps and brain buzzing began, headache, fatigue, numbness to right side of face to neck. By day 5 (27Dec2020) made its way to left side. Twitching of face when do certain movements. Her Dr gave her Prednisone and she took 50 mg for 4 days and stopped because she couldn't differentiate the tingling in hands and feet from shot or from that. Still brain zaps, newest issue sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips. Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off. Whole body still weak, eyes hurt. Head a lot better than a day ago but still having buzzing and twitching. Today was day 18. She was awaiting an MRI with contrast on Friday hoping it got moved sooner as she was scared to what was going on. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included CT/MRI/Optic Nerve Scan/Pain Shot/Meds for Zaps. The events were non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 28Dec2020. The action taken in response to the events for prednisone was permanently withdrawn on an unspecified date. The outcome of the events reported as not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all these reported serious events might not be fully excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Contrast media allergy; Latex allergy,,,"['Asthenia', 'Computerised tomogram', 'Dysgraphia', 'Eye pain', 'Fatigue', 'Feeling abnormal', 'Hand-eye coordination impaired', 'Headache', 'Hypoaesthesia', 'Inappropriate schedule of product administration', 'Magnetic resonance imaging', 'Memory impairment', 'Muscle twitching', 'Neuralgia', 'Ocular discomfort', 'Optical coherence tomography', 'Paraesthesia', 'SARS-CoV-2 test negative', 'Screaming', 'Tinnitus']",UNK,UNKNOWN MANUFACTURER, 953078,TX,55.0,F,"Heart fluttering; chest pressure; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EK5730; expiration date: not known), via an unspecified route of administration in the left arm at hospital on 31Dec2020 10:00 at at single dose for COVID-19 immunization. Medical history included known allergies with sulfa. The patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took clarithromycin (BIAXIN), metronidazole benzoate (FLAGYL), and sulfamethoxazole, trimethoprim (BACTRIM), and all but experienced allergies (reported as ""known allergies: Biaxin, Flagyl, sulfa, Bactrim""). No COVID prior to vaccination and no COVID tested post vaccination. The patient experienced heart fluttering and chest pressure on 04Jan2021. There was no treatment received for the reported events. The outcome of the events was not recovered.; Sender's Comments: A causal relationship between the reported heart fluttering and the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,PVT,,,"Medical History/Concurrent Conditions: Sulfonamide allergy (Known allergies: Biaxin, Flagyl, sulfa, bactrim)",,,"['Cardiac flutter', 'Chest discomfort']",1,PFIZER\BIONTECH, 953080,NC,26.0,F,"Tachycardia up to 150 resting; Nausea; Vomiting; Diarrhea; Headache; Migraine; Body aches; Chills; Fever up to 102; This is a spontaneous report from a contactable nurse (patient). This 26-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248), intramuscular on 08Jan2021 at 07:45 AM at single dose on right arm for COVID-19 immunisation. Medical history included anxiety and depression. No known allergies. Concomitant medication included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), diphenhydramine hydrochloride (ZZZQUIL). No other-vaccine-in-four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK5730), intramuscular on 22Dec2020 at 08:00 PM on right arm for COVID-19 immunisation. The patient experienced tachycardia up to 150 resting, nausea, vomiting, diarrhea, headache, migraine, body aches, chills and fever up to 102. Symptom onset around 7PM on 08Jan2021 and stopped around 12PM 09Jan2021 except for headache which was still persisting as of 9PM 09Jan2021. No treatment was received for the events. The outcome of headache was not recovered. The outcome of other events was recovered on 09Jan2021 at 12PM. The patient did not have COVID-prior-vaccination. The patient did not have COVID tested post vaccination.; Sender's Comments: The reported tachycardia was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,PROZAC; WELLBUTRIN; ZZZQUIL,,Medical History/Concurrent Conditions: Anxiety; Depression,,,"['Chills', 'Diarrhoea', 'Headache', 'Migraine', 'Nausea', 'Pain', 'Pyrexia', 'Tachycardia', 'Vomiting']",2,PFIZER\BIONTECH,OT 953081,CA,24.0,M,"Bell's palsy onset within 48 hours of second vaccine, R side of face; First dose of vaccine on 20Dec2020 and second dose received on 06Jan2021; First dose of vaccine on 20Dec2020 and second dose received on 06Jan2021; This is a spontaneous report from a contactable healthcare professional reporting for himself from a Pfizer sponsored program. A 24-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EJ1686) via an unspecified route of administration, on 06Jan2021 at 11:30am on left arm, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were reported as none. The patient had no known allergies. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0140) at right arm on 20Dec2020 10:30am for COVID-19 immunization. On 08Jan2021 at 12:00pm, the patient experienced facial droop 2 days after taking the 2nd dose of the vaccine. The patient went to the hospital for doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and were advised to take Valtrex and Prednisone and told its Bell's palsy. Bell's palsy onset within 48 hours of second vaccine, R side of face. Wanted to confirm if there will be a problem once they take these drugs since the paient have just received the vaccine recently or wanted to know if the new medications prescribed will affect the vaccine's effectivity. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post vaccination. Outcome of the event Bell's palsy was not recovered.; Sender's Comments: Facial droop/ Bell's palsy occurred 2 days after taking the 2nd dose of the BNT162B2 vaccine, a possible causal association between administration of BNT162B2 and the event onset thus might not be fully excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Facial paralysis'],2,PFIZER\BIONTECH, 953083,AZ,37.0,F,"7 days later diagnosed with pneumonia; 3 days after developed hives on my stomach and arm; felt tired; confused; unwell; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730), via an unspecified route of administration on the left arm on 28Dec2020 12:00PM at a single dose for COVID-19 immunization at hospital facility. Medical history included Hashimotos disease. The patient had no known allergies and has not had COVID prior to vaccination. The patient's concomitant medications were not reported. The patient reported that she felt tired and confused and unwell on day of injection, 28Dec2020. After three days (31Dec2020), she developed hives on her stomach and arm and seven days later (04Jan2021), she was diagnosed with pneumonia and continued to have hives all over her legs and arms to this day. The patient was treated with antibiotics for pneumonia. She underwent Covid test/ Nasal swab post vaccination on 09Jan2021, pending result. The outcome of the events was not recovered.; Sender's Comments: The reported pneumonia was more likely an intercurrent disease, and unlikely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Hashimoto's disease,,,"['Confusional state', 'Fatigue', 'Malaise', 'Pneumonia', 'SARS-CoV-2 test', 'Urticaria']",1,PFIZER\BIONTECH, 953084,MO,28.0,F,"difficult breathing; Pain on the chest; Not being able to move my upper neither lower body; itchiness all over my body; unconscious; Headaches; major anxiety; depression; very light-headed; weak; almost faint; This is a spontaneous report from a contactable Other HCP (patient). A 28-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 12:00 at single dose on Left arm for COVID-19 immunisation. Facility type vaccine was Hospital. Medical history was none. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced Not being able to move my upper neither lower body, Headaches, major anxiety, and depression, unconscious, very light-headed, weak, almost faint, Pain on the chest, difficult breathing, itchiness all over my body on 08Jan2021. AEs resulted in Emergency room/department or urgent care, Hospitalization. Received injected fluids as treatment. The outcome was Not Recovered. No COVID prior vaccination. No COVID tested post vaccination. Information on the lot/ batch number has been requested.; Sender's Comments: Based on a close temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Anxiety', 'Asthenia', 'Chest pain', 'Depression', 'Dizziness', 'Dyspnoea', 'Headache', 'Loss of consciousness', 'Mobility decreased', 'Pruritus']",1,PFIZER\BIONTECH, 953086,TN,31.0,F,"I had a very early miscarriage at five weeks; I had a very early miscarriage at five weeks; I had a very early miscarriage at five weeks; This is a spontaneous report from a contactable Physician (patient). A 31-year-old female patient received BNT162B2 first dose of (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJI685) intramuscular at arm right on 19Dec2020 06:30 at single dose for covid-19 immunization. Facility type vaccine was hospital. Medical history was none. The patient had no known allergies or other medical history. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. The patient experienced a very early miscarriage at five weeks on 01Jan2021. The event result in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of the event miscarriage was recovered in Jan2021. No covid prior vaccination and no covid tested post vaccination.; Sender's Comments: All pregnancies have a risk of birth defect, loss, or other adverse outcomes. The data on BNT162B2 administered to pregnant women is insufficient to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Abortion spontaneous', 'Exposure during pregnancy']",1,PFIZER\BIONTECH,OT 953087,PA,24.0,F,"almost pass out; Chills; nausea; diarrhea; abdominal pain; clammy; elevated heart rate; dizzy; This is a spontaneous report from a contactable consumer (patient's parent). A 24-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via an unspecified route of administration on left arm on an unspecified date in Dec2020 at single dose for COVID-19 immunization. The relevant medical history included asthma, migraines and anxiety all from an unspecified date. Concomitant medications included ethinylestradiol, etonogestrel (NUVARING), topiramate (TOPAMAX), verapamil and sertraline hydrochloride (ZOLOFT). The patient experienced chills, nausea, diarrhea, abdominal pain, clammy, elevated heart rate, almost pass out, dizzy, all on 05Jan2021. The patient had no treatment for the events. No covid prior vaccination. The patient underwent lab test included heart rate showed elevated on 05Jan2021, Nasal Swab showed negative on 06Jan2021. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,01/05/2021,35.0,PVT,NUVARING; TOPAMAX; ; ZOLOFT,,Medical History/Concurrent Conditions: Anxiety; Asthma; Migraine,,,"['Abdominal pain', 'Chills', 'Cold sweat', 'Culture negative', 'Diarrhoea', 'Dizziness', 'Exposure during pregnancy', 'Heart rate increased', 'Nausea']",1,PFIZER\BIONTECH, 953089,TN,21.0,F,"Rash on lower legs similar to that seen with Thrombocytopenia.; Rash on lower legs similar to that seen with Thrombocytopenia.; This is a spontaneous report from a contactable Other HCP (patient). A 21-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number= EJ1686), via an unspecified route of administration at Left arm on 05Jan2021 10:00 AM at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient's medical history and concomitant medications were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rash on lower legs similar to that seen with thrombocytopenia on 09Jan2021 at time of 12:00 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: A possible contributory effect of suspect drug on reported thrombocytopenia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/10/2021,5.0,PVT,,,,,,"['Rash', 'Thrombocytopenia']",1,PFIZER\BIONTECH, 953090,AZ,41.0,F,"Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went to work to a COVID unit which she usually didn't do; described her symptoms as a chest cold; Feeling strange like coming down; swelling and soreness in the injection site for a day or two; swelling and soreness in the injection site for a day or two; This is a spontaneous report from a contactable nurse reported for self. This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 07Jan2021 13:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) for COVID-19 immunization on an unspecified date. On 07Jan2021 after second dose vaccination, the patient started experiencing swelling and soreness in the injection site for a day or two. On 08Jan2021 the next day, she went to work to a COVID unit which she usually didn't do. On 08Jan2021 the next day after her shift at 15:00 PM, she started feeling strange like coming down. On 09Jan2021, she felt totally fatigued. The symptom that bothered her the most is the sore in her throat which has gone 10Jan2021, she said she lost her voice (hoarse). She was also experiencing a reddish nose and intermittent coughs. She described her symptoms as a chest cold. The patient also stated she didn't have fever or chills. She's afraid she might be sick. The outcome of event the sore in her throat was resolved on 10Jan2021. The outcome of other events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported chest cold cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,,,,,,"['Aphonia', 'Cough', 'Dysphonia', 'Erythema', 'Exposure to SARS-CoV-2', 'Fatigue', 'Feeling abnormal', 'Injection site pain', 'Injection site swelling', 'Lower respiratory tract infection', 'Oropharyngeal pain']",2,PFIZER\BIONTECH, 953092,WY,48.0,F,"tingling sensation in right eye and mid cheek area,Unable to wink, or scrunch right eye; muscles on the right side of my face were noticeably weaker; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), via an unspecified route of administration, on 23Dec2020 at 04:00 PM at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was vaccinated at Public Health Clinic/Veterans Administration facility, age at vaccination was 48-years-old. No other vaccine was received in four weeks. Medical history included gastrooesophageal reflux disease (GERD). Known allergies included levofloxacin (LEVOFLOXACIN), pethidine hydrochloride (DEMEROL), phenobarbital, cefalexin monohydrate (KEFLEX), charithromycin (BIAXIN). Concomitant medications included dexlansoprazole (DEXILANT), estradiol, phentermine, ergocalciferol (VIT D), calcium. The patient was not tested for covid prior or post vaccination. On 23Dec2020 at 04:45 PM, after leaving the clinic, the patient felt tingling sensation in right eye and mid cheek area. Within 1.5 hours, muscles on the right side of her face were noticeably weaker. Unable to wink, or scrunch right eye. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was treated with prednisone. Outcome was recovering.; Sender's Comments: Based on a close temporal relationship causality between events ""tingling sensation in right eye and mid cheek area"" and ""muscles on the right side of her face were noticeably weaker"" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,PUB,DEXILANT; ; ; VIT D;,,Medical History/Concurrent Conditions: GERD,,,"['Eyelid function disorder', 'Facial paresis', 'Paraesthesia']",1,PFIZER\BIONTECH, 953093,AR,79.0,F,"She is still freezing to death; Sick as a dog; Fever; Chills; cannot eat and have no appetite; nauseous; This is a spontaneous report from a contactable nurse (patient). A 79-year-old female patient received first dose of bnt162b2 (also reported as Pfizer Covid vaccine, lot number: EK4176), intramuscular into left arm on 05Jan2021 16:00 at single dose indicated as presentation because she is a nurse/Covid-19 immunization. Medical history included Type 2 Diabetes, about 2 years ago in 2019 in which she takes metformin 1,000mg twice daily. Concomitant medication included metformin on unspecified date at 1,000mg twice daily for Type 2 Diabetes. There was no history of all previous immunization with the Pfizer vaccine nor there were additional vaccines administered on same date of the Pfizer Covid vaccine. The patient received the Pfizer COVID vaccine last Tuesday and since 06Jan2021 at 06:00, she has been sick as a dog. She is running a fever, has chills, can't eat and has no appetite because she is nauseous; all on 06Jan2021 at 06:00. This is the third day of it. She would like to know what she can she do. She said that it all started Wednesday morning when she got up. It just gets worse every day. It looks like it would get better by now, but it hasn't. She never runs a temperature, but she has now (unspecified date). She is still freezing to death on unspecified date. She usually has a good appetite. Even the thought of food makes her sick. She further reported that she has had nothing but chills, fever, and nausea and states it will not go away. She is treating it with ibuprofen. She confirms she already talked to a nurse in this department to report this and she was transferred to see what she could do and states they never answered. This is her first dose and she does not know if she should get the second dose. The patient can't calm down since she has been sick since last Wednesday. She stated that she needed some help because she is so sick. She was suggested to call again calling Pfizer medical information department. She stated that she had called back three times, but there is no such number. The events sick as a dog, fever, chills, can't eat and has no appetite, and nauseous were considered serious (Other medically important condition). The outcome of the events sick as a dog, fever, chills, can't eat and has no appetite, and nauseous was not recovered, and the outcome of the remaining event was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completed based on known safety profile and a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PHM,,,"Medical History/Concurrent Conditions: Type 2 diabetes mellitus (2 years ago. She takes Metformin 1,000mg twice daily.)",,,"['Chills', 'Decreased appetite', 'Feeling cold', 'Malaise', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH,OT 953095,MA,49.0,F,"palms of my hands were bright red; very warm flush feeling; nausea; swelling of the throat; rash on my arms and abdomen; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiration date not provided), intramuscular in the left arm on 06Jan2021 16:00 (at the age of 49 years old) at a single dose for COVID-19 immunization. Medical history included psoriasis, microscopic colitis, allergies to shellfish, and coconut. The patient's concomitant medications were not reported. The patient previously took estrogen patch, etanercept (ENBREL) and sulfamethoxazole, trimethoprim (BACTRIM) and experienced allergies to all. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and did not take any other medications with 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Jan2021 16:15, the patient experienced a very warm flush feeling, nausea started and by 15 minutes, she had swelling of the throat and rash on her arms and abdomen and the palms of her hands were bright red. The events resulted in Emergency room/department or urgent care visit. The patient was treated with diphenhydramine hcl (BENADRYL), steroids (unspecified), famotidine (PEPCID) and ondansetron (ZOFRAN) in response to the events. The patient assessed the events as non-serious. The outcome of the events was recovered with sequel on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Colitis microscopic; Food allergy; Psoriasis; Shellfish allergy,,,"['Erythema', 'Hot flush', 'Nausea', 'Pharyngeal swelling', 'Rash']",1,PFIZER\BIONTECH,OT 953097,,,F,"glaucoma; This is spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first shot and was scheduled to receive the second dose on 27Jan2021 however, she has an eye surgery for glaucoma scheduled on 22Jan2021 and 25Jan2021. The patient wanted to know if she re-schedule the eye surgery. The outcome of the event glaucoma was unknown. Follow-up activities are possible, information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Unevaluable event'],1,PFIZER\BIONTECH, 953098,,,F,"Stevens Johnson Syndrome; rash was starting to peel; developed a rash all over her neck/ the rash has spread to face eyes, cheek; developed a rash all over her neck, ""looks like its peeling and taut""; developed a rash all over her neck, ""looks like its peeling and taut""; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (Age: 48, Unit unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 at single dose for covid-19 immunization. Medical history included she had an allergic reaction to sulfa and developed Stevens Johnson syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced Stevens Johnson Syndrome, developed a rash all over her neck/ the rash has spread to face eyes, cheek; ""looks like its peeling and taut""; and the rash was starting to peel, all in Jan2021. The patient received 1st dose of vaccine on 10Jan2021, developed a rash all over her neck, ""looks like its peeling and taut"". She had an allergic reaction to sulfa and developed Stevens Johnson syndrome, this looks similar to that (Experience of Stevens Johnson Syndrome). The patient was asking if she did take the steroid dose pack from her dermatologist for the skin rash will it prohibit her from taking the second dose of the vaccine. She called yesterday and reported a rash after receiving the first dose of the COVID-19 vaccine. She stated that she went to her Dermatologist this morning because the rash has spread to face eyes, cheek and the rash was starting to peel. She stated that the dermatologist wanted to know if it was safe to treat her with a prednisone dose pack after receiving the vaccine. Her rash was worsening so she went to her dermatologist for treatment. She was asking if she should get the second dose. The outcome of events for developed a rash all over her neck/ the rash has spread to face eyes, cheek was not resolved, for other events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of suspect Stevens Johnson Syndrome presented as skin reactions cannot be excluded, considering the plausible temporal relationship. Severe allergic reaction is the known risk for the vaccine. The underlying predisposing condition of an allergic reaction to sulfa developed Stevens Johnson syndrome may put the patient at high risk of the similar occurrence. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/01/2021,,UNK,,,,,,"['Rash', 'Skin exfoliation', 'Stevens-Johnson syndrome']",1,PFIZER\BIONTECH, 953099,MI,31.0,F,"following day around 7pm lip swelling; tongue tingling; body hives; chills; After first dose of Covid vaccine face flushing; increased HR about 45 mins. went away on its own; hours later left eye swollen; This is a spontaneous report from a contactable Nurse (patient). A 31-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot number: EK9231), via an unspecified route of administration on 06Jan2021 15:00 at single dose on Left arm for covid-19 immunisation. Medical history included Known allergies: Shellfish, IV contrast dye, Penicillin. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient experienced after first dose of covid vaccine face flushing; increased hr about 45 mins. went away on its own since 06Jan2021 16:00; hours later left eye swollen on 06Jan2021; following day around 7pm lip swelling, tongue tingling, body hives, chills on 07Jan2021 19:00. The patient underwent lab tests and procedures which included heart rate: increased on Jan2021. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Ae treatment: Steroids, IV fluids, Benadryl. No COVID prior vaccination. No COVID tested post vaccinate. This report was reported non-serious. The event outcome of increased hr about 45 mins. went away on its own was recovered on 06Jan2021 16:45, outcome of other events were not recovered.; Sender's Comments: Based on the compatible time association, the serious events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Contrast media allergy; Penicillin allergy; Shellfish allergy,,,"['Chills', 'Eye swelling', 'Flushing', 'Heart rate increased', 'Lip swelling', 'Paraesthesia oral', 'Urticaria']",1,PFIZER\BIONTECH, 953101,WV,91.0,F,"kidneys weren't acting/kidney issues; not having the feeling to urinate; Light-headed; This is a spontaneous report from a contactable consumer (reported for herself). A 91-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3248; expiration date: not known), via an unspecified route of administration in the left arm on 07Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure and blood thinner. Concomitant medication included apixaban (ELIQUIS) for blood thinner. The patient is asking if there were any reports of adverse events with kidneys and the vaccine. She received the 1st shot last Thursday (07Jan2021) and told that yesterday (10Jan2021), she had an episode where kidneys weren't acting. She also mentioned that she is on a blood thinner, ELIQUIS. She is due to receive the 2nd shot on 28Jan2021. She said that she wouldn't want to receive the 2nd dose if this was related to her adverse reaction. The issue with the kidney started after on 10Jan2021, yesterday she was really having problems, she went to church then came home by that time she would have to go to the bathroom, but she did not go, she ended up cooking dinner which was 3 hours later, she was noticing that she was not urinating. She drank some Gatorade and that made it little better, she is wondering if it's a side effect. On 10Jan2021, when she noticed the kidney issues, she did not know for certain if it started before that, she didn't pay attention. Also, yesterday (10Jan2021), she got sick in which she had to grab the counter, she felt bad, she wasn't dizzy, but felt light-headed. The symptom of not having the feeling to urinate had improved a little today but she is concerned and wanted to know if this was a side effect. Her being light-headed only occurred on 10Jan2021, it was a onetime occurrence yesterday. However, she was also just sitting around, laying around, after that yesterday. The outcome of the event 'light-headed' was unknown; while outcome of other events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/10/2021,3.0,UNK,ELIQUIS,,Medical History/Concurrent Conditions: Anticoagulant therapy; Blood pressure high,,,"['Blood pressure increased', 'Dizziness', 'Feeling abnormal', 'Malaise', 'Renal disorder', 'Urinary retention']",1,PFIZER\BIONTECH, 953102,GA,42.0,F,"difficulty thinking; Extreme fatigue; dizziness; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received her second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 11:15 at single dose at Arm Right for COVID-19 immunisation. Medical history included hypothyroidism, thyroid cancer, hypertension from an unknown date and ongoing, Known allergies: Latex, aluminium, nickel.The patient was not pregnant. Concomitant medication included gabapentin, propranolol, levothyroxine sodium (SYNTHROID), and pantoprazole. The patient has previously received her first dose of BNT162B2 on 20Dec2020 08:45 PM for COVID-19 immunisation at Arm left. There was no any other vaccines within 4 weeks prior to the COVID vaccine.The patient experienced difficulty thinking, extreme fatigue and dizziness resulted in Doctor or other healthcare professional office/clinic visit. All the events occurred on 11Jan2021 09:00 with outcome of recovering. No treatment was received. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.The events were considered as non-serious. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the mental impairment and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/11/2021,1.0,WRK,; ; SYNTHROID;,Hypertension,Medical History/Concurrent Conditions: Allergy to aluminium; Hypothyroidism; Latex allergy; Nickel sensitivity; Thyroid cancer,,,"['Dizziness', 'Fatigue', 'Mental impairment']",2,PFIZER\BIONTECH, 953105,VA,,U,"concern for injection to the subcutaneous tissue/concerned about improper administration/patient has a mark where you can see the vaccine and it's higher up where you expect it to be; induration at the injection site; felt induration was moving down his/her arm/can feel it migrated down her arm, 7 inches below injection site; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176), subcutaneous (reported as injection to the subcutaneous tissue to deltoid) on 09Jan2021 at 0.3 mL, single to prevent from getting COVID. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 for COVID-19 immunization. On 09Jan2021, within a couple hours after, the patient experienced induration at the injection site. The patient felt induration was moving down his/her arm with concern for injection to the subcutaneous tissue. The patient can feel it migrated down his/her arm, 7 inches below injection site. The reporter assessed that the causality was yes for the suspect drug and the patient was concerned about improper administration. The reporter was unsure if it is administration or vaccine, the patient has a mark where you can see the vaccine and it's higher up where you expect it to be. Outcome of the vaccination site induration and induration was not recovered. The events were considered medically significant by the reporter.; Sender's Comments: Based on the available information a causal relationship between reported events induration at the injection site / induration and incorrect route (subcutaneous) of BNT162B2 vaccine administration cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,UNK,,,,,,"['Incorrect route of product administration', 'Injection site induration']",2,PFIZER\BIONTECH,OT 953107,,36.0,F,"Slight left sided facial weakness/droop 4 days post vaccination; Slight left sided facial weakness/droop 4 days post vaccination; Tingling in injected arm and facial tingling in cheeks/lips same day of vaccination/Tingling to lower extremities; Tingling in injected arm and facial tingling in cheeks/lips same day of vaccination; Tingling in injected arm and facial tingling in cheeks/lips same day of vaccination; This is a spontaneous report from a contactable consumer (patient herself). A 36-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EK9231), via an unspecified route of administration in the left arm on 04Jan2021 13:00 at single dose, for Covid-19 immunisation. The vaccine was given in a Nursing Home/Senior Living Facility. Medical history was none. No known drug allergies. No other vaccine in four weeks. No Covid-19 prior vaccination. Concomitant medication included naproxen sodium (ALEVE). The patient experienced tingling in injected arm and facial tingling in cheeks/lips same day of vaccination (04Jan2021). Tingling to lower extremities the day after vaccination (still continuing). Slight left sided facial weakness/droop 4 days post vaccination (04Jan2021). Tingling to left arm continuing on and off. No treatment reported. On 04Jan2021, she was negative to PCR covid test post vaccination. She went to the Emergency room/department or urgent care. The outcome of events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,OTH,ALEVE,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Facial paralysis', 'Facial paresis', 'Paraesthesia', 'Paraesthesia oral', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 953109,AL,36.0,M,"slurring speech; rash around his neck and upper chest; his earlobes were bright red, as was his nose; mouth was dry; nose was dry; dry throat; almost ""drunk""; Only abnormal finding was BP 159/94; This is a spontaneous report from contactable pharmacist. A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1283 and Expiration Date unknown) via Intramuscular on 08Jan2021 11:25 at single dose for COVID-19 immunisation. The patient's medical history was reported toradol made him feel lightheaded and foggy (similar to his first Pfizer BioNTech covid vaccine), Attention deficit hyperactivity disorder (ADHD). History vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number =EK5730 and Expiration Date unknown) via Intramuscular on 18Dec2020 at single dose for COVID-19 immunisation. Patient did report that on first vaccine it made him feel a little sluggish, tired and foggy minded. The concomitant medications were reported as amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall XR) at 25mg twice a day (BID) and escitalopram oxalate (LEXAPRO) oral (PO) at 10mg every day. No other vaccine in four weeks. Patient was vaccinated at 11:25. Patient was observed for 30 minutes. Pharmacist checked on patient at 17 minutes after vaccination - he was fine able to communicate and showed no signs of distress. Pharmacist came back and checked on patient at 25 minutes after vaccination (11:50) and patient was slurring speech, had developed rash around his neck and upper chest, his earlobes were bright red, as was his nose - mouth was dry, reported dry throat - no visible swelling of the lips or tongue. Patient was transported to ED (2 min) Home meds: Adderall XR 25mg BID [Twice a day], Lexapro 10mg Q [every]PM. Only abnormal finding was BP 159/94 - after initial workup patient was noted to be almost ""drunk"" as reported by Emergency Room (ER Doc). Patient was offered diphenhydramine declined several times but eventually agreed. Approx 30 min after diphenhydramine patient fully recovered and stated ""I'm back"". The second dose reaction was much more exaggerated and lasted much longer. No COVID prior vaccination and no COVID tested post vaccination. The adverse event result in Emergency room/department or urgent care. The outcome of events was recovered in Jan2021 after treatment was given.; Sender's Comments: Based on the time association, all events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,LEXAPRO; ADDERALL,,Medical History/Concurrent Conditions: ADHD,,,"['Blood pressure abnormal', 'Dry mouth', 'Dry throat', 'Dysarthria', 'Erythema', 'Feeling drunk', 'Rash']",2,PFIZER\BIONTECH,OT 953110,NY,,U,"SOB; leukocytosis; acute onset of fever (101.2); CXR = bilateral vascular congestion; This is a spontaneous report from a contactable consumer. An elderly NH resident patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced shortness of breath (SOB), leukocytosis (17,800), acute onset of fever (101.2), bilateral vascular congestion. The patient was admitted with acute onset of fever (101.2), leukocytosis (17,800, no eosinophilia) and SOB, all beginning 3-4 hours after BNT162B2 administration. CXR showed bilateral vascular congestion. No facial or SQ edema. No evidence of myocardial damage or CHF based on BNP and troponin, respectively. The patient was treated with brief (3 days) pulse of methylprednisolone sodium succinate (SOLUMEDROL) with improvement. Chalking it up to acute capillary leak syndrome 2^2 vaccine. The final events outcome was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,Living in nursing home,,,,"['Brain natriuretic peptide normal', 'Chest X-ray abnormal', 'Dyspnoea', 'Eosinophil count normal', 'Leukocytosis', 'Pulmonary congestion', 'Pyrexia', 'Troponin normal', 'White blood cell count increased']",UNK,PFIZER\BIONTECH, 953111,,,F,"Blood in stool; Fever; Night sweats; Chills; Ache; This is a spontaneous report from a contactable physician reporting for herself. An adult (reported as 30-something year old) female patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on 30Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. The patient experienced blood in stool in Jan2021 with outcome of unknown, chills on 31Dec2020 with outcome of unknown, ache on 31Dec2020 with outcome of unknown, fever in Jan2021 with outcome of unknown, night sweats in Jan2021 with outcome of unknown. The patient reported that 24 hours after vaccination she experienced chills and aches, and after the 24 hours experienced some significant fevers that wouldn't break and chills. Then, after about 2 hours, the fever would break and come back and it was like a cycle. Also had night sweats and blood in her stools after that. The information on the lot/batch number has been requested.; Sender's Comments: The female patient received the 1st dose of bnt162b2 (BNT162B2) on 30Dec2020, and experienced blood in stool in Jan2021 with outcome of unknown. The information available is limited, and case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/31/2020,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Haematochezia', 'Night sweats', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 953129,KY,74.0,F,"Patient presented to our Emergency Department via EMS in full code status; asystole. Patient expired. Per nursing, husband stated patient awoke this AM and reported pain in back between shoulders and in bilateral shoulders. Patient then went unresponsive and husband called EMS.",Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/18/2021,9.0,PVT,unknown,none known,hypertension; colon cancer (recovered); smoker,,none,"['Arthralgia', 'Back pain', 'Cardiac arrest', 'Death', 'Unresponsive to stimuli']",1,MODERNA,IM 953183,PA,83.0,M,1/11/21 at 8:57 Resident with fever and at 11 am saturation down to 83 O2 to 10 liters. Resident continued to decline until CTB on 1/14/2021 at 1325,Yes,01/14/2021,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/11/2021,6.0,UNK,,,,,,"['Oxygen saturation decreased', 'Pyrexia', 'Respiratory arrest']",1,PFIZER\BIONTECH,IM 953208,FL,81.0,M,"Heart rate slowed significantly down to 32bpm Tightness in chest, trouble breathing Elevated blood pressure",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/16/2021,01/16/2021,0.0,PUB,,,"Coronary artery disease, heart attacks, strokes, atrofibulation, diabetes, bladder cancer",,,"['Blood pressure increased', 'Chest discomfort', 'Dyspnoea', 'Heart rate decreased', 'Laboratory test']",1,PFIZER\BIONTECH, 953249,TN,37.0,F,"injection site became red & swollen, the size of a softball. Employee started having seizure like symptoms on 1/14/21 and was admitted to hospital. DC from hospital on 1/16/21 and on 1/17/21 started having seizures again and readmitted back to hospital. Employee has no history of seizures.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/12/2021,01/14/2021,2.0,SEN,unknown,unknown,unknown,,unknown,"['Computerised tomogram', 'Electrocardiogram', 'Injection site erythema', 'Injection site swelling', 'Magnetic resonance imaging', 'Seizure', 'Seizure like phenomena']",1,MODERNA,IM 953333,,81.0,M,"patient began with vomiting and diarrhea the day after administration, leading to bowel and urine incontinence. patient was hospitalized on 01/16/20 with sepsis. no origin discovered yet. still waiting on blood/urine/stool cultures.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,01/12/2021,01/12/2021,0.0,UNK,,,,,,"['Anal incontinence', 'Blood culture', 'Chest X-ray normal', 'Culture stool', 'Culture urine', 'Diarrhoea', 'Sepsis', 'Urinary incontinence', 'Urine analysis normal', 'Vomiting', 'White blood cell count increased']",UNK,PFIZER\BIONTECH, 953348,AR,81.0,M,Patient was living in a nursing home with positive cases when administered. His age and chronic condition was such that he did not have time after the vaccination to avoid exposure or develop immunity.,Yes,01/14/2021,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/24/2020,2.0,SEN,"Atorvastatin, Ibuprofen, Oxybutinin, Morphine Sulfate",,"Chronic pain, high blood pressure",,None,['Death'],1,MODERNA,IM 953357,IA,86.0,F,Resident had seizure like activity that was about 30 minutes in duration where her upper/lower extremities were shaking uncontrollably. Resident had to be admitted into hospital for observation.,Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/16/2021,01/16/2021,0.0,SEN,Calcium-Vitamin D Tablet 500-200 MG-UNIT (Calcium Carb-Cholecalciferol) Give 1 tablet by mouth two times a day for supplement Clopidogrel Bisulfate Tablet 75 MG Give 1 tablet by mouth in the morning related to OTHER CEREBROVASCULAR DISEASE,NONE,"HEMIPLEGIA, UNSPECIFIED AFFECTING RIGHT DOMINANT SIDE (G81.91) URINARY TRACT INFECTION, SITE NOT SPECIFIED (N39.0) DIFFICULTY IN WALKING, NOT ELSEWHERE CLASSIFIED (R26.2) MUSCLE WEAKNESS (GENERALIZED) (M62.81) TYPE 2 DIABETES MELLITUS WITH HYPERGLYCEMIA (E11.65) OTHER CEREBROVASCULAR DISEASE (I67.89) VASCULAR DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE (F01.50) ESSENTIAL (PRIMARY) HYPERTENSION (I10) APHASIA (R47.01) MAJOR DEPRESSIVE DISORDER, SINGLE EPISODE, UNSPECIFIED (F32.9) HYPERLIPIDEMIA, UNSPECIFIED (E78.5) TYPE 2 DIABETES MELLITUS WITH UNSPECIFIED DIABETIC RETINOPATHY WITH MACULAR EDEMA (E11.311) OCULAR HYPERTENSION, BILATERAL (H40.053) MULTIPLE FRACTURES OF RIBS, LEFT SIDE, SUBSEQUENT ENCOUNTER FOR FRACTURE WITH ROUTINE HEALING (S22.42XD)",,NONE,"['Computerised tomogram head', 'Magnetic resonance imaging', 'Seizure like phenomena', 'Tremor']",1,PFIZER\BIONTECH,IM 953394,MA,76.0,M,"blistering rash - bullous pemphigoid, steroids, admitted to hospital pending further evaluation.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/13/2021,01/14/2021,1.0,SEN,,,,,NKDA,"['Pemphigoid', 'Rash vesicular']",UNK,PFIZER\BIONTECH, 953397,,,U,"1day after vaccine,developed severe headache & later blister in head officially Shingle . Then decreased platelet count fatally to 29(ITP).now hospitalized getting treatment.",Not Reported,,Yes,Yes,4.0,Not Reported,N,,,,UNK,,,,,,"['Blister', 'Headache', 'Herpes zoster', 'Immune thrombocytopenia', 'Platelet count decreased']",1,MODERNA,SC 953402,ND,45.0,F,"Was feeling anxious right after vaccine given. Laid in cot for a short time, then stated her throat felt like it was closing.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,PUB,Unknown,Unknown,Unknown,,Imitrex,"['Anxiety', 'Immediate post-injection reaction', 'Throat tightness']",1,PFIZER\BIONTECH,IM 953404,FL,70.0,M,Severe rash. Platelets drop to almost needing transfusion,Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/09/2021,01/11/2021,2.0,PVT,Lipitor Synthroid Vit C D zinc,None,ITP,,Penicillin,"['Platelet count decreased', 'Rash']",1,MODERNA,IM 953470,VA,85.0,F,"1252 Resident rang with complaints of chest pain and shortness of breath. BP 126/70, Temp 97.5, pulse 72, resp. 20, O2 sats on room air 90%. While awaiting transport complained of increasing shortness of breath. Resident transported to Community Hospital via Ambulance with 3L O2 . Resident placed on ventilator and transported to Medical Center",Not Reported,,Not Reported,Yes,,Not Reported,N,01/16/2021,01/16/2021,0.0,SEN,"Paroxetine 20mg daily, Multivitamin daily, B12 injections Monthly","Tested positive for Covid-19 on 12/11/2020, tested negative 12/30/2020","Osteoporosis, COPD",,No known allergies,"['Chest X-ray abnormal', 'Chest pain', 'Dyspnoea', 'Mechanical ventilation', 'Pneumonia', 'SARS-CoV-2 test positive', 'Troponin increased']",UNK,PFIZER\BIONTECH,IM 953549,NM,,M,"shingles (herpes zoster); Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. In or around April 2018, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX). The event of herpes zoster was considered to be disabling.",Not Reported,,Not Reported,Not Reported,,Yes,N,04/01/2018,,,UNK,,Routine health maintenance,,,,"['Emotional distress', 'Herpes zoster', 'Impaired quality of life', 'Pain']",UNK,MERCK & CO. INC.,OT 953552,OH,,U,"shingles and other zoster-related conditions; shingles and other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 01-NOV-2015, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for long-term prevention of shingles and zoster related conditions (prophylaxis). Subsequently, the patient was treated by a healthcare provider for shingles and other zoster-related conditions. As a direct and proximate result of the patient's use of the vaccine live (ZOSTAVAX) vaccine, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and cost included care for hospitalization, physician care, monitoring, treatment, medications, and supplies: diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffered such losses, and damages in the future. The outcome of the event s was not provided. Therefore, the causality for the event was related to zoster vaccine live (ZOSTAVAX).",Not Reported,,Not Reported,Yes,,Not Reported,U,11/01/2015,,,PHM,,,,,,['Herpes zoster'],UNK,MERCK & CO. INC., 953587,NJ,55.0,M,"severe body aches; severe chills; night sweats; Fatigue; This is a spontaneous report from a contactable Physician (patient). A 55-year-old male patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at 12:00 at single dose in left arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose bnt162b2 in Dec2020 three weeks ago at 12:00 noon in the left arm for covid-19 immunization and experienced mild pain at the injection site which lasted two days and then was gone. The patient experienced severe body aches, severe chills, night sweats, and fatigue on 07Jan2021. Event details: The patient reported that he received the first dose of the Pfizer COVID 19 vaccine three weeks ago at 12:00 noon in the left arm. He did not know the exact date. After the first dose there was mild pain at the injection site which lasted two days and then was gone. He received the second dose of the Pfizer COVID 19 vaccine on 06Jan2021 at 12:00 noon in the left arm. He noticed 12 hours later severe body aches, severe chills, and night sweats. He also felt fatigue. Everything had mostly resolved except for the night sweats and they were still pretty severe. All events were reported as serious by reporter per medically significant. The outcome of event night sweats was not resolved, outcome of other events was resolved on 10Jan2021. Information about lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported severe body aches, severe chills, fatigue and night sweats, and the administration of the COVID 19 vaccine, bnt162b2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Chills', 'Fatigue', 'Night sweats', 'Pain']",2,PFIZER\BIONTECH, 953589,,68.0,F,"eosinophil count is 12.2%; Congestion; rhinitis; Cough; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on 21Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient who is an MD received the COVID vaccine on 21Dec2020. She quickly developed rhinitis, cough, and congestion which have persisted. Her eosinophil count is 12.2%. She received a Medrol pack, but it did not relieve her symptoms. She has delayed her second injection for now. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,,,UNK,,,,,,"['Cough', 'Eosinophil percentage increased', 'Respiratory tract congestion', 'Rhinitis']",UNK,PFIZER\BIONTECH, 953590,NY,82.0,M,"resident expired; This is a spontaneous report from a contactable healthcare professional. An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0140), intramuscular in the left arm on 05Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included metabolic encephalopathy from, failure to thrive (FTT), diabetes mellitus (DM) 2 , chronic obstructive pulmonary disease (COPD), arthritis, weakness, hyperlipidemia, chronic kidney disease (CKD), dementia. Known allergies was none. The patient took unspecified concomitant medication. On 11Jan2021, the resident expired. The patient underwent lab tests and procedures which included nasal swab: negative on 09Jan2021. There was no treatment given for the event. The patient died on 11Jan2021. An autopsy was not performed.; Sender's Comments: Lacking information on the cause of patient's demise, the Company cannot completely exclude a causal relationship between COVID 19 vaccine, BNT162B2, and patient's death of unknown cause, as a cautionary measure and for reporting purposes. The patient's pre-existing medical condition of metabolic encephalopathy from, failure to thrive (FTT), diabetes mellitus (DM) 2 , chronic obstructive pulmonary disease (COPD), arthritis, weakness, hyperlipidemia, chronic kidney disease (CKD), dementia may have provided the contribution to the event in this 82-year-old male patient. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: resident expired",Yes,01/11/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/11/2021,6.0,OTH,,,Medical History/Concurrent Conditions: Arthritis; Chronic kidney disease; COPD; Dementia; Diabetes mellitus; Failure to thrive; Hyperlipidemia; Metabolic encephalopathy; Weakness,,,"['Culture negative', 'Death']",1,PFIZER\BIONTECH,OT 953592,SC,36.0,F,"Facial paralysis; This is a spontaneous report from a contactable consumer (patient herself). A 36-year-old female patient received bnt162b2 (COVID-19 Vaccine by Pfizer, lot EK9231, expiry date was not reported), via an unspecified route of administration on 08Jan2021 at SINGLE DOSE for Covid-19 immunisation (to prevent the COVID). Medical history was none. There were no concomitant medications. The patient experienced facial paralysis on the left side of her face upon waking up on 09Jan2021. The outcome of event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Facial paralysis'],1,PFIZER\BIONTECH, 953596,,,U,"Congestion in my lungs; I am coughing up junk; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced congestion in lungs and was reportedly coughing up ""junk"" on an unspecified date. It was also reported that the patient woke up this morning with a pretty bad side effect. Outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Productive cough', 'Pulmonary congestion']",UNK,PFIZER\BIONTECH, 953598,FL,29.0,F,"Started to have symptoms and fainted; Hit her nose and has a scar now; She blacked out; hit her nose, got the scar in the nose, �she was bleeding from that scar; hit her nose, got the scar in the nose, �she was bleeding from that scar; She started to feel unwell; Chills; Nausea; Rash in her arm; She had little red in her bumps; This is a spontaneous report from a contactable physician. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. and expiry date: unknown), via an unspecified route of administration on arm on unspecified date at a single dose (2nd dose) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Physician stated, ""she had no medical conditions, she was in very good you know very like standing with herself."" Patient had her 1st dose of Covid vaccine on unspecified date for COVID-19 immunization. Physician (reporter) stated, ""I am the parent of someone who got the COVID dose, the second dose yesterday. I am very concerned because my daughter yesterday (08Jan2021) started to have symptoms and fainted at 4:00 in the morning and hit her nose and has a scar now. She had her second dose yesterday (pending clarification), after the second dose last night she started to feel unwell, getting chills, nausea and when she got up to go to the bathroom, she fainted, she blacked out. She lives alone, she is an adult, she hit her nose, got the scar in the nose, and the bleeding wouldn't stop, she was bleeding from that scar. She told me it took two hours for bleeding to stop from that scar."" When asked when the events started, Physician stated, ""Last night (08Jan2021), at 4:00 am she took the shot during the day while she was at work. She said, she started to getting chills and then she was nauseated."" When asked if patient was still experiencing the event, the parent reported no as patient was just resting. Also stated, ""She didn't take any treatment but she said she took Tylenol."" Physician further added, ""I am concerned, we are going to be taking her to the urgent care now but I am concerned about what is going on with platelets and all of that because of what had happened, last night the bleeding wouldn't stop for two hours and she was alone at the night and weekends. She said, she had to lay down and then her dad is there now because he is closer, he is going to be taking care of the urgent care but I want Pfizer to know what my daughter has gone through last night after she took this second dose."" Physician further added, ""she is having a rash in her arm, she had little red in her bumps as well. I want her to go get checked up as soon as possible in urgent care."" Patient was taking some Ibuprofen (later clarified that patient took Tylenol as treatment). She was not taking any other medication. Outcome of the events was unknown. Information Requested on Lot/ Batch number.; Sender's Comments: The reported faint was most likely due to an accident, and less likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/08/2021,0.0,UNK,,,,,,"['Chills', 'Haemorrhage', 'Loss of consciousness', 'Malaise', 'Nasal injury', 'Nausea', 'Rash', 'Rash erythematous', 'Scar', 'Syncope']",2,PFIZER\BIONTECH, 953601,,,F,"Respiratory complications; This spontaneous case was received on 07-Jan-2021 from other non-health professional (consumer) via Health Authority (reference number: SEQW21-00081) and concerned an adult, female patient. At the time of this report, the patient was a 39-year-old. The patient's concurrent conditions included severe asthma and brain tumor that was not cancerous. The patient's concomitant medications were not reported. On an unknown date in 2018, reported as both 13-Oct-2018 and mid Monday, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was YF41408, expiration date: 30-Jun-2019. On the same day in the night, after receiving Afluria Quadrivalent, the experienced severe respiratory complications, so she went to the emergency room and was hospitalized. The patient did not exactly remember the treatment measures, but she usually got anything respiratory related, steroid injections, nebulizer, and oxygen. On an unspecifed date in 2018, a week after the admission, the patient was discharged. She did not remember the admission or the discharge date. The patient stated that since then she had not received any influenza vaccine, but now she was trying to figure out if she will have the same reaction to COVID-19 vaccine. The outcome of event was not reported. The reporter did not provide causality assessment. The event of 'respiratory disorder NOS' was considered serious due to seriousness criteria of hospitalization. Company comment:The patient developed respiratory disorder (reported as severe respiratory complications) on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Causality was confounded by patient's medical history of severe asthma. The patient's concomitant medications were not reported. Since the event was not specified, at this moment causal relationship is assessed as unassessable due to lack of information regarding event characteristics.; Sender's Comments: The patient developed respiratory disorder (reported as severe respiratory complications) on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Causality was confounded by patient's medical history of severe asthma. The patient's concomitant medications were not reported. Since the event was not specified, at this moment causal relationship is assessed as unassessable due to lack of information regarding event characteristics.",Not Reported,,Not Reported,Yes,7.0,Not Reported,U,,,,UNK,,Asthma; Benign brain neoplasm NOS,,,,['Respiratory disorder'],UNK,"SEQIRUS, INC.",OT 953630,CA,49.0,U,"1) Skin rash over 80% of my body including, face and lips; started to change my voice sound and started to compromise my airways. 2) Uncontrollable shakes, but not sure if this was related to Covid-19 itself. Was given steroids via injection into my blood stream, within minutes the shakes stopped and within 2 hours the rash was gone.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/17/2021,01/17/2021,0.0,PVT,"VITAMIN D, C, AND ZINC","I had Covid 19 at the time the vaccine was administered, I tested positive that same night.",Non,"Had the same type of rash/reactions to Chloroquine, which shares the Polyethylene_glycol component with the Covid vaccione","I'M ALLERGIC TO DG6 OR MOST LIKELY IODINE, AND TO CHLOROQUINE WHICH HAS Polyethylene_glycol, A COMPONENT OF MODERNA COVID VACCIONE. I DID NOT KNOW ABOUT THIS COMPONENT. I WAS ASKED IF I HAD ADVERSE REACTIONS TO COMPONENTS IN THE MODERNA VACCIONE BUT I WAS ASKED IF I HAD ADVERSE REACTIONS TO CHOLOROQUINE.","['Allergy to vaccine', 'Cheilitis', 'Dysphonia', 'Laboratory test', 'Obstructive airways disorder', 'Rash', 'SARS-CoV-2 test positive', 'Tremor']",1,MODERNA,IM 953671,MO,63.0,F,12/22 Vaccine 12/23 ER. Admitted to hospital for 7 days. Dr stated was due to fluid. Radiology stated no fluid present. Couldn't breath. Pulmonologist put on 2nd inhaler. Coughing a lot. Not able to walk more then 6 steps without stopping to catch breath. *Has had 2nd vaccination on 1/13/2020,Not Reported,,Not Reported,Yes,7.0,Not Reported,N,12/22/2020,12/23/2020,1.0,PVT,"vitamins daily; Gabapentin, omeprazole, albuterol",,"asthma, thyroid, arthritis",,"raspberries, errthromycin, aspartame","['Blood test', 'Cough', 'Dyspnoea', 'Dyspnoea exertional', 'Fluid retention', 'Full blood count', 'International normalised ratio', 'Metabolic function test', 'X-ray normal']",1,PFIZER\BIONTECH,SYR 953720,MO,63.0,F,1/12 vaccination 1/13 swelling and pain at injection site. Admitted for 4 days.,Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/12/2021,01/13/2021,1.0,PVT,,,Asthma,,"Raspberries, Erythromycin, aspertein","['Glomerular filtration rate', 'Injection site pain', 'Injection site swelling']",2,PFIZER\BIONTECH,SYR 953754,NJ,74.0,F,patient suddenly developed pneumonia 7 days after vaccination and died the evening of developing pneumonia,Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/13/2021,7.0,SEN,not provided by facility,,"COVID-19 4/24/2020, hyperlipidemia, type 2 diabetes, generalized idiopathic epilepsy, chronic gingivitis, paranoid schizophrenia, extrapyramidal movements (G25.9), BMI 29, major depressive disorder, hypertensive heart disease, GERD",,no known allergies,"['Death', 'Pneumonia']",1,PFIZER\BIONTECH,IM 953774,PA,35.0,F,"Couple hours after the vaccine, experienced elevated temperature, difficulty taking full deep breathes (attributed to fatigue). Temperature improved but fatigue and shortness of breathe continued until 1/16/21. a bilater arm rash occurred and employee went to the Emergency Department for an assessment. At this time, she was having chest tightness, shortness of breathe. Lab - troponins elevated. Other labs - within normal limits. Admitted to hospital for observation and discharged next day. Today, during cardiac follow-up appt, was having decreased oxygen saturation levels, increased pulse rate. Admitted again today for obsevation with cncern of acute endocarditis.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/14/2021,01/14/2021,0.0,OTH,Albuterol prn,NONE,Exercise induced asthma,,NKDA or food allergies,"['Body temperature increased', 'Chest discomfort', 'Dyspnoea', 'Fatigue', 'Heart rate increased', 'Laboratory test normal', 'Oxygen saturation decreased', 'Rash', 'Troponin increased']",2,PFIZER\BIONTECH,IM 953785,FL,73.0,F,Death,Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/16/2021,9.0,PHM,No scheduled medications Tylenol and Zyrtec as needed,None,None Known,"Hypersensitivity/ anaphylaxis to standard flu vaccine (egg containing) ~ 20 years ago. Of note, did tolerate FluBlok this past",Egg (anaphylaxis) Chicken,"['Autopsy', 'Death']",1,MODERNA,IM 953790,NY,36.0,F,"1 hour post injection patient returned with redness and borderline hives in her left arm, chest, neck and face. She complained of feeling very hot and with mental confusion. We administered 50 mg of diphenhydramine, and 15 minutes later sent her to the ED. At the ED they diagnosed her with a minor anaphylaxis reaction, gave her methylprednisolone and epinephrine.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/18/2021,01/18/2021,0.0,SEN,none,none,"Asthma, Anemia",,"Sulfa, Cefaclor","['Anaphylactic reaction', 'Confusional state', 'Erythema', 'Feeling hot', 'Urticaria']",2,PFIZER\BIONTECH,SYR 953794,NE,23.0,F,"Individual felt fine except a sore arm until 1/5/2021 legs became weak and dizziness and light headed and did t"" feel well"" and passed out. had general muscle weakness and went to ER. She was given fluid for possible dehydration and went home and weakness increase and went back to ER and was admitted to hospital for testing.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/30/2020,01/05/2021,6.0,PVT,None,None,None,,seasonal allergies/ latex,"['Blood creatine phosphokinase abnormal', 'Dizziness', 'Laboratory test normal', 'Loss of consciousness', 'Lumbar puncture normal', 'Magnetic resonance imaging normal', 'Malaise', 'Muscular weakness', 'Pain in extremity']",1,MODERNA,IM 953858,TN,76.0,F,"patient started to decline 1/10/2021, patient seen at facility by medical professional - patient deceased 1/13/2021",Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/13/2021,5.0,SEN,"Seroquel, ibandronate, atenolol, Lexapro, simvastatin, acetaminophen, estradiol, famotidine, calcium citrate, antacid, donepezil, ferrous sulfate, Probiotic Pearls Complete, memantine, Antifungal cream, potassium chloride, Creon, bisacodyl","COVID-19, ARDS, enterocolitis, Sepsis, UTI, Acute renal failure","Chronic kidney disease, dementia with lewy bodies, COPD, GERD, anxiety, anemia, osteoarthritis, unspecified heart failure, paroxysmal atrial fibrillation",,nka,"['Death', 'General physical health deterioration']",UNK,MODERNA,IM 953865,RI,99.0,M,REPORTING ONLY AS RESIDENT EXPIRED ON 1/17/2021 3 DAYS AFTER. S/S HYPOXIA/CONGESTED LUNG SOUNDS,Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/17/2021,3.0,SEN,"FINASTERIDE 5MG QD, FAMOTIDINE 20 MG DAILY, FOLIC ACID 400 MCG QD, SENNA 8.6 DAILY",NONE,"HYPOTHYROIDISM, DEMENTIA, SCHIZOPHRENIA, HTN, DYSPAGIA, INTELLECTUAL DISABILITIES, CKD MACULAR DEGENERATION",,NKA,"['Breath sounds abnormal', 'Death', 'Hypoxia', 'Pulmonary congestion', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 953874,LA,43.0,M,"12/20/2020 12/21/2020 Notices lymneos above left clavicle swollen and hard, bruising at the sight location of left arm. Several weeks and present at the second shot .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/20/2020,2.0,PVT,No,No,No,,No,"['Blood test', 'Induration', 'Injection site bruising', 'Swelling']",1,PFIZER\BIONTECH,IM 953882,WA,29.0,M,ventricular fibrillation cardiac arrest. Witnessed collapse. Bystander CPR performed. Paramedics performed ACLS with defibrillation x 6 before ROSC,Not Reported,,Not Reported,Yes,,Not Reported,Y,01/10/2021,01/11/2021,1.0,PVT,none,none,none,,NKDA,"['Arteriogram coronary normal', 'Blood calcium decreased', 'Cardiac arrest', 'Cardioversion', 'Echocardiogram abnormal', 'Ejection fraction decreased', 'Magnetic resonance imaging heart', 'Resuscitation', 'Syncope', 'Ventricular fibrillation', 'Ventricular hypokinesia']",1,MODERNA,IM 953888,TX,34.0,M,"PVCs with compensatory pauses, postural orthostatic hypotension associated with chest tightness, shortness of breath, dizziness and blurry vision",Not Reported,,Yes,Yes,1.0,Not Reported,N,12/22/2020,01/09/2021,18.0,PVT,,,Prediabetes,"A day following COViD vaccine on 12/23/2020 had arm soreness, chills and generalized body aches.",,"['Cardiac telemetry abnormal', 'Chest discomfort', 'Dizziness', 'Dyspnoea', 'Echocardiogram', 'Electrocardiogram abnormal', 'Orthostatic hypotension', 'Palpitations', 'Scan myocardial perfusion normal', 'Ventricular extrasystoles', 'Vision blurred']",1,PFIZER\BIONTECH,IM 953909,MO,15.0,F,"Headaches for 1 and a half weeks prior to visit with primary care provider on 12/16/2020. Started petechiae on lips on 12/14/2020, headache, nausea, chills, low grade fever of 99.9. 12/15/20 petechiae spread to legs and large spots in her mouth. Took her into PCP for rash, now spread to entire body except lower arms, hands and bottoms of feet. PCP sent her to Emergency Room. Emergency Room ran CBC and plateletes were Zero. COVID-19 results for antigen and antibody both negative. Admitted to hospital with Thrombocytopenia; Acute ITP. Received IVIG treatements with low response. Then started on IV high dose Methylprednisone - released with 26,000 platelets on 12/21/2020.",Not Reported,,Not Reported,Yes,6.0,Not Reported,U,11/03/2020,12/14/2020,41.0,PVT,"Ibuprofen, tylenol, zyrtec - all as needed. Multi-Vitamin","Dizzy when she stood up, heavier cycle (but not abnormally so). Did CDC on 11/04/2020 to check for anemia. All results were normal from CBC.",None,,"Seasonal, dogs","['Chills', 'Headache', 'Immune thrombocytopenia', 'Immunoglobulin therapy', 'Nausea', 'Petechiae', 'Platelet count decreased', 'Pyrexia', 'Rash', 'SARS-CoV-2 antibody test negative', 'SARS-CoV-2 test negative']",2,MERCK & CO. INC.,IM 953922,MA,72.0,M,"The day following the vaccine, the patient complained of throat issues and anxiety. This was not new... however . That evening he reported difficulty breathing and was placed on oxygen; a COVID test was performed and was negative. On 12/30/2020, patient complained of sternal pressure and was transferred to the hospital. The patient died 12/31/2020 and records obtained from the hospital indicated the patient died from a massive myocardial infarction.",Yes,12/31/2020,Not Reported,Yes,2.0,Not Reported,N,12/26/2020,12/27/2020,1.0,SEN,,"Diabetes, COPD, Chrone's Disease, DJD, OSA, PTSD, GERD, HLD, Depression, HTN, lobectomy 3/4/2019, cancer",See above,,NKDA,"['Anxiety', 'Chest discomfort', 'Death', 'Dyspnoea', 'Myocardial infarction', 'Oropharyngeal discomfort', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 953926,NC,74.0,M,Seizure,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/07/2021,01/12/2021,5.0,PUB,"2.5mg Tadalafil once daily,40mg Pantoprazole once daily",,"BPH, Acid Reflux",,"tetracycline, seasonal allergies","['Computerised tomogram', 'Echocardiogram', 'Electrocardiogram', 'Electroencephalogram', 'Magnetic resonance imaging', 'Seizure']",UNK,MODERNA, 953997,GA,23.0,F,WITHIN 30 SECONDS OF RECEIVING VACCINE PATIENT STATED THAT SHE DID NOT FEEL WELL. HER FACE BECAME FLUSHED. HER LIPS BECAME NUMB AND HER TONGUE AND THROAT STARTED SWELLING. AN EPIPEN WAS ADMINISTERED AND 911 CALLED. AFTER THE EPIPEN SYMPTOMS BEGAN TO RESOLVE. EMS CHECKED HER OUT AND SHE REFUSED TRANSPORT.,Not Reported,,Yes,Not Reported,,Not Reported,Y,01/18/2021,01/18/2021,0.0,PHM,NONE,NONE,NONE,,NONE,"['Flushing', 'Hypoaesthesia oral', 'Immediate post-injection reaction', 'Malaise', 'Pharyngeal swelling', 'Swollen tongue']",1,MODERNA,IM 954001,CO,40.0,F,"Received dose 1 of vaccine and on day of and day after of vaccine administration experienced headache, chills, fatigue. and body aches--all flu like symptoms pregnancy info not avl from report filed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,PVT,,,,,,"['Chills', 'Exposure during pregnancy', 'Fatigue', 'Headache', 'Influenza like illness', 'Pain']",1,PFIZER\BIONTECH,IM 954036,WV,30.0,F,"Fatigued for the rest of the day and following day, causing me to take multiple naps and was not able to complete some normal daily activities. Mild headache in the afternoon/evening on day of vaccine. Approximately 10 weeks pregnant at time of vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"Prenatal vitamins, 3mg folic acid",None,Exercise induced asthma - well managed,"Gardasil, ~18 years old, dizzy and felt as though I would pass out.",No known allergies,"['Exposure during pregnancy', 'Fatigue', 'Headache', 'Hypersomnia', 'Loss of personal independence in daily activities']",1,PFIZER\BIONTECH,SYR 954097,WI,65.0,F,"Chief Complaint: low blood pressure, tachycardia, SOB after last Friday's Covid shot. Pt. meeting SIRS criteria with elevated lactate, WBCs, and tachycardia. Given fluid bolus and IV ABX.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/18/2021,3.0,PVT,"alendronate (FOSAMAX) 70 mg tablet Take 1 tablet (70 mg total) by mouth every 7 (seven) days. cholecalciferol (Vitamin D3) 2,000 Unit capsule � Take 1 tablet by mouth daily. � estradioL (ESTRING) 2 mg (7.5 mcg /",N/a,Colitis Ulcerative Pancolonic Urticaria Chronic Malabsorption Glucose Neuritis Optic Bone Disorder,Shingrix (2/12/2018 and 5/25/2018),Penicillins Experienced urticaria while taking penicillin. Sulfa (sulfonamide Antibiotics) Experienced urticaria while taking penicillin then was transitioned to Sulfa antibiotic and rash worsened along with fever.,"['Blood lactic acid increased', 'Dyspnoea', 'Hypotension', 'Systemic inflammatory response syndrome', 'Tachycardia', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 954154,TX,45.0,F,"8 hours after vaccine severe injection site pain/swelling, severe body aches, 101.0 temp. 16 hours after vaccine woke up from sleeping with flushed skin, facial swelling, and throat swelling. I immediately took 100mg of Benadryl and went to hospital emergency room. Approximately 30-40 minutes later symptoms started to lessen. Once at the ER, at the same time symptoms began to resolve, I was given PO Solumedrol and Pepcid. I was monitored and then discharged with RX for prednisone, and EPIPEN (to use if needed). No other issues with allergic reaction. Mild injection site soreness, mild body aches, 99.3 temp persist at 36 hours post injection.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/17/2021,01/17/2021,0.0,PVT,"Nature Thyroid, HCTZ, Vitamin D, Multivitamin, Vitamin C, Quercetin, Turmeric, CO Q10",None,"Hypothyroid, hypertension",,None,"['Body temperature increased', 'Flushing', 'Hypersensitivity', 'Injection site pain', 'Injection site swelling', 'Pain', 'Pharyngeal swelling', 'Sleep disorder', 'Swelling face']",2,MODERNA,IM 954251,,71.0,F,"71 year old woman at rehabilitation center for physical therapy with history of cirrhosis of the liver, asthma, and heart condition was tested for COVID-19 on 01/07/21, received 1st dose of Pfizer COVID-19 vaccine on 01/08/21, positive test result for COVID-19 received on 01/09/21. She was sent to the hospital and admitted on 01/12/21 after O2 was 70% and was in a confused state. Patient passed away on 01/17/21.",Yes,01/17/2021,Not Reported,Yes,,Not Reported,,01/08/2021,01/12/2021,4.0,UNK,,"Cirrhosis of the liver, asthma, heart condition","Cirrhosis of the liver, asthma, heart condition",,,"['Confusional state', 'Death']",UNK,PFIZER\BIONTECH, 954265,DE,27.0,F,"Received shot Wednesday night, developed arm soreness and mild flu like symptoms on left side of my body and facial paresthesias on the left side of my face. Twelve hours later, after waking up those same symptoms were only on the right side of my body. Friday morning, mostly normal physically just with some overall fatigue. Friday afternoon I started to get hives on my chest and overnight into Saturday they were on my lower back, sides, and legs. I took 50 mg of Benadryl every 6-12 hours until Monday mid-day when Benadryl was not helping reduce the hives and so I had full body hives. I did try an drugstore cortisone cream which did not help. Sought treatment at an urgent care as I was feeling anxious and could not control the itching. I and was diagnosed with likely allergic reaction to the covid-19 vaccine.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/13/2021,01/15/2021,2.0,WRK,Adderall 15 mg xr,"ADD, gastric sleeve surgery, chronic sinusitis","Chronic sinusitis, ADD, history of diabetes but no longer diabetic (as of 2019)",,None,"['Anxiety', 'Fatigue', 'Hypersensitivity', 'Influenza like illness', 'Pain in extremity', 'Paraesthesia', 'Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,IM 955627,TX,53.0,F,"Hx Covid infection Had Covid vaccine #1 - no problems Within 1 hr after Covid vaccine #2 progressed to SOB, pruritis throat tickle TxT-ed self with Benadrl but symptoms persisted Went to ED txt with Bendryl, prednisone, zyrtec.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2020,01/12/2020,0.0,WRK,Albuterol inhaler,No,Post covid infection SOB,,No,"['Dyspnoea', 'Pruritus', 'Throat irritation']",UNK,PFIZER\BIONTECH,IM 954295,NY,,F,"immobility; swelling; insomnia; hives around the injection site; More pain than the average vaccines; This spontaneous report was received from a consumer referring to his wife a 58-year-old female patient.. Patient's concurrent conditions included cancer and allergy to sulfur based medications. Concomitant medications included, atorvastatin calcium (LIPITOR) and semaglutide (OZEMPIC). Information regarding patient's historical conditions was not provided. On an unspecified date in 2020 (reported as ""roughly a month ago""), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 1 dosage form in the right arm, to prevent pneumonia (prophylaxis) (strength, administration route, lot number and expiration date were not provided). On 01-DEC-2020 (reported as ""6 weeks ago""), the patient experienced Immobility (paralysis), more pain than the average vaccine caused, swelling, insomnia and then she developed hives around the injection site. No treatment was given for the events, and a blood work was performed. The outcome of the events was reported as recovered/resolved. The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). Upon internal review, Immobility was determined to be a medically significant event.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/01/2020,,UNK,LIPITOR; OZEMPIC,Allergic reaction to drug excipient; Cancer,,,,"['Blood test', 'Immobile', 'Injection site urticaria', 'Insomnia', 'Pain', 'Paralysis', 'Swelling']",UNK,MERCK & CO. INC., 954305,TX,64.0,F,"She woke up soaking wet. She had sweats kind of.; Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable nurse (patient herself) reported that a 64-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730, expiry date not reported), via an unspecified route of administration in the upper left arm on 21Dec2020 17:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included ongoing hypertension (blood pressure high). She was a former smoker, a teenage smoker. She has not smoked since the age of 19 years old. Concomitant medication included amlodipine for high blood pressure. The patient informed that she was vaccinated on 21Dec2020. On 05Jan2021, she had a positive COVID Test and she was wondering when she should have the second dose of the COVID Vaccine. She thought initially she just had a cold. She took the COVID test as a precaution. It started out with a stuffy nose. She had a congested cough, upper airway cough, nothing deep in the lungs. She had a low grade fever. It was like 99.9. It was possible it was higher, but she had taken Ibuprofen at night. She woke up soaking wet. She had sweats kind of. Her temperature however never registered a true fever if a fever was considered 100.4. She was not really having body aches any more unusual than one would have for a 64 year old. She has a very mild sore throat. Her stuffy nose had improved, it's still there slightly, but not like it was the first few days. The outcome of events was unknown.; Sender's Comments: Test positive for covid19 found 14 day following the first dose of COVID-19 vaccination, bnt162b2, no adequate effect of the suspect vaccine thus could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,01/05/2021,15.0,PVT,,,Medical History/Concurrent Conditions: Hypertension; Smoker,,,"['Cough', 'Nasal congestion', 'Night sweats', 'Oropharyngeal pain', 'Pyrexia', 'Respiratory tract congestion', 'SARS-CoV-2 test positive', 'Upper-airway cough syndrome']",1,PFIZER\BIONTECH, 954308,IL,43.0,F,"received the first dose of vaccine in a hospital on 18Dec2020/tested positive for COVID on 01Jan2021; received the first dose of vaccine in a hospital on 18Dec2020/tested positive for COVID on 01Jan2021; This is a spontaneous report from a contactable nurse (patient) via Pfizer-sponsored program, Pfizer First Connect. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EK5730, expiration 31Mar2021) , via an unspecified route of administration in left arm, on 18Dec2020 at 15:00, at 0.3 mL, single, for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient received the first dose of vaccine in a hospital on 18Dec2020 at 15:00 as she works in emergency room and tested positive for COVID on 01Jan2021. The patient stated that the second dose is scheduled this afternoon (08Jan2021) and wants to know if she should proceed with the vaccine. The patient is looking for guidance on whether or not to get the second dose or wait. The patient has been directed to receive second COVID vaccine. No additional vaccines administered on the same date. The event required a visit to urgent care. The patient did not have prior vaccinations within 4 weeks. No events prior to vaccination. The patient underwent lab tests and procedures which included COVID 19: positive on 01Jan2021. Outcome of the events was unknown. The event was assessed as serious (medically significant). The event ""Tested positive for COVID"" was assessed as unrelated to COVID vaccine as her husband was COVID positive before her.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,01/01/2021,14.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 954311,PA,,F,"She reported being exposed to her husband, who tested positive for COVID, and that she tested positive following her first vaccine dose; She reported being exposed to her husband, who tested positive for COVID, and that she tested positive following her first vaccine dose; She reported being exposed to her husband, who tested positive for COVID, and that she tested positive following her first vaccine dose; This is a spontaneous report from a contactable female nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. and expiry date unspecified) via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if it is safe to get the second dose of the vaccine after being exposed to or having COVID? She reported being exposed to her husband (on an unspecified date), who tested positive for COVID, and that she tested positive following her first vaccine dose. She got her Covid-19 vaccine on the 23Dec2020 and tested positive for Covid-19 on the 28Dec2020. She was scheduled to get the next dose on Wednesday and wants to know if she should still get it. Outcome of the events drug ineffective, COVID-19 and Exposure to COVID-19 was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 23Dec2020, and COVID-19 test positive on 28Dec2020. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID test was likely associated with being exposed to her husband, who had COVID-19. Further information is needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/28/2020,5.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 954314,LA,53.0,F,"She had sniffles and post nasal drip; Got first dose then went to (Entertainment complex name) and contracted COVID/tested positive after getting the 1st dose; Tested positive after getting the 1st dose; She returned home with sniffles, fatigue, and no taste/She had sniffles and post nasal drip; This is a spontaneous report from a contactable nurse (patient) via Pfizer-sponsored program: IBCC (Inbound Call Center for HCPs). A 53-year-old female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, exp date not reported), via an unspecified route of administration on 19Dec2020 for given since patient works with COVID patients (COVID-19 immunisation). The patient had no relevant medical history. There were no concomitant medications. Nurse called asking if she can get the 2nd dose of the vaccine 6 days after the 21st day. She tested positive on 05Jan2021 after getting the 1st dose and was still in quarantine. The nurse works at a hospital. She received her first dose of the COVID-19 Vaccine on 19Dec2020, and afterwards donated blood on the same day. She got the vaccine through her place of work. She said when she donated blood on 19Dec2020, her blood was tested for the COVID-19 Virus antibodies, and her blood was negative for the virus antibodies. She lives about 30 mins from work, so she thought she would get both done in the same day. She gave blood right before she got the vaccine. She gave the blood then went and got the Vaccine. She said on 26Dec2020 she went to Entertainment complex as it was her vacation. Her and her family went for 4 days. On 30Dec2020 she returned home with sniffles, fatigue, and no taste. She said she tested positive for the COVID-19 Virus on 05Jan2021. On 30Dec2020 they got back, and on 02Jan2021 she had sniffles and post nasal drip. On 03Jan2021 she did not wanna get out of bed. She was profoundly fatigued. She also lost her smell. She had to go back to work on 07Jan2021, but did not want to go back in unless she was sure she was okay because she works with babies. She had no other symptoms after 03Jan2021, except no smell and no taste. She got tested for COVID and was positive on 05Jan2021 (also reported as 06Jan2021 [pending clarification]). Her and her husband were both positive, but her kids were not. The weird thing was she also on 06Jan2021 got her results back from giving blood and she was negative for COVID on 19Dec2020 prior to getting the vaccine. Caller clarifies that her COVID test was a nasal swab. Patient thought her age may have contributed to her feelings of fatigue. She had indicated she worked in either a hospital NICU or nursery, and that is why she had to quarantine for 14 days. She probably would not have even gotten tested for COVID if she was not a nurse and did not know that losing taste and smell were a sign. She feels fine. She said she was scheduled for her second dose of the COVID-19 Vaccine on 12Jan2021. She said she was now in quarantine for 14 days due to testing positive for the COVID-19 Virus, and her quarantine period ends on 14Jan2021. Since now she is in quarantine, she will miss her second dose which was supposed to be on 12Jan2021. She said she rescheduled her second dose of the COVID-19 Vaccine to 18Jan2021, which was 6 days later than when she was supposed to receive the 2nd COVID-19 Vaccine dose. She asked if getting the dose 6 days late was okay. The events were considered as non-serious by the reporter. The outcome of the events was unknown.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,12/30/2020,11.0,WRK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No",,,"['Ageusia', 'Anosmia', 'Fatigue', 'Rhinorrhoea', 'SARS-CoV-2 test positive', 'Upper-airway cough syndrome']",1,PFIZER\BIONTECH, 954315,SC,48.0,M,"tested positive for COVID; tested positive for COVID; achiness; Chills; not feeling well; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient's wife) reported similar events for four patients. This is the first of four reports. A 48-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as Pfizer-Biontech Covid-19 Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 17Dec2020 at single dose, for Covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient received the vaccine last 17Dec2020. The following day, 18Dec2020, he was not feeling well. Clarified those side effects as achiness and chills. He had been working so hard and thought initially were getting side effects from the COVID Vaccine. He was tested positive for COVID on 22Dec2020. He was in bed basically until 31Dec2020. His wife wants to know if he should get the second dose. The outcome of events was recovered. Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021019513 same drug, similar events, different patient;US-PFIZER INC-2021019535 same drug, similar events, different patient;US-PFIZER INC-2021019534 same drug, similar events, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Bedridden', 'Chills', 'Malaise', 'Pain', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 954321,IL,31.0,F,"tested positive for SARS-COV-2; tested positive for SARS-COV-2; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect, received from a contactable nurse (patient). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 18Dec2020 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient received first dose of vaccine on 18Dec2020 and tested positive for SARS-COV-2 20Dec2020. She reported ""las major symptom"" on 27Dec2020 and asked if it was okay to take the second dose. Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Positive SARS-COV-2 came back 2 days following the vaccine use is compatible with COVID 19 infection. No adequate effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/20/2020,2.0,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 954325,CA,48.0,M,"Fevers; Chills; he is suspecting that he got infected with the Covid-19 though he already received the 1st dose; he is suspecting that he got infected with the Covid-19 though he already received the 1st dose; Body aches; Patient suspected that he has gotten infected also from his spouse; This is a spontaneous report from a contactable physician (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 (Tuesday) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported body aches developing the evening of receiving the vaccine, and it has persisted for three days. Patient started to get the chills on Wednesday (06Jan2021). Patient said his wife has been tested positive after he took the 1st dose and he is suspecting that he got infected with the Covid-19 though he already received the 1st dose. Patient thought that he may have been infected by his spouse. He got the vaccine on Tuesday and on Wednesday had fever and chills and still has them. Stated that his spouse lost her sense of smell and taste and tested positive for Covid on Wednesday. Patient stated that this was the day after he received his vaccine. Patient suspected that he has gotten infected also from his spouse and was not aware when he got the vaccine. Stated that now that he is having expected side effects of fever and chills. The outcome events was not recovered. This case was reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: The subject received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 05Jan2021, and suspected got COVID-19 infection via exposure to COVID-19 living with his wife, who lost her sense of smell and taste and tested positive for COVID on 06Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Further information is needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'Chills', 'Exposure to SARS-CoV-2', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 954331,TN,59.0,F,"exposed to her 6 month old grand daughter who was positive; tested and received a positive test result, without symptoms.; tested and received a positive test result, without symptoms.; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration at the right arm on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included high blood pressure from 2001 and ongoing. There were no concomitant medications. Patient had the flu, shingles and pneumonia vaccines and a booster for MMR in the past 6 months. Patient was exposed to COVID-19 on 01Jan2021. Patient was tested on 07Jan2021 and received a positive test result on 08Jan2021. Patient does not have any symptoms. She was exposed to her 6 month old grand daughter who was positive. The doctor said he thinks it was a false positive. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/08/2021,9.0,UNK,,Blood pressure high,,,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 954348,,,M,"Tested positive for the Covid virus; Tested positive for the Covid virus; This is a spontaneous report from a contactable nurse. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 29Dec2020 and four days ago, he tested positive for the Covid virus (02Jan2021). The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Test positive for the Covid virus found 4 day following the vaccination, no adequate effect of the suspect vaccine thus could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/02/2021,4.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 954353,,,F,"the symptoms as ""having Covid all over again""; the symptoms as ""having Covid all over again""; headache; nausea; severe joint and body pain; body pain; coughing; fever; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included covid-19 from an unknown date. The patient's concomitant medications were not reported. The patient just got the Covid vaccine and was experiencing side effects. She described the symptoms as ""having Covid all over again"", mentioned headache, nausea, severe joint and body pain, coughing and fever on an unknown date. Want to see how long these side effects last. The outcome of the events was unknown. Information regarding lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Arthralgia', 'Cough', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 954354,,,F,"caller was rushed to the emergency room and was tested positive for COVID-19; caller was rushed to the emergency room and was tested positive for COVID-19; caller became symptomatic and experienced headaches; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first dose on 18Dec2020 and is scheduled for the second dose today, 09Jan2021. However, on 24Dec2020, she became symptomatic and experienced headaches. On Saturday, she was rushed to the emergency room and was tested positive for COVID-19. Her physician told her that she could get the COVID-19 vaccine if she has no symptoms anymore. She wanted to know the guidance per Pfizer. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 09Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/24/2020,6.0,UNK,,,,,,"['Headache', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 954362,,,F,"got a positive test on 31Dec2020. Her 2nd dose is due on Wed and she is currently symptomatic.; got a positive test on 31Dec2020. Her 2nd dose is due on Wed and she is currently symptomatic.; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program . A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 31Dec2020, the patient got a positive test. Her 2nd dose was due on wed and she was currently symptomatic. Patent would to know if she should get second dose on her scheduled date even though she still was feeling unwell. The outcome of the events was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,12/31/2020,,UNK,,,,,,"['Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 954372,CA,,F,"COVID test result as positive; COVID test result as positive; Chills; Body aches; Headache; Weakness; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: 49899, unknown expiration), intramuscular in right arm, in Dec2020 at 09:00 AM, at single dose, for COVID-19 immunization. Medical history included asthma, hypothyroid, and interstitial cystitis. The patient has no known allergies. Concomitant medication included influenza vaccine in right arm (lot number: US47SAA) on 08Dec2020 for immunization. Patient also received other unspecified medication within two weeks of vaccination. COVID-19 vaccine was administered in a hospital. On 23Dec2020 at 01:30 AM, the patient woke up with chills, body aches, headache and weakness. On 31Dec2020, the patient had nasal swab for COVID with COVID test result as positive post vaccination. Patient is not pregnant at the time of vaccination. The patient did not have COVID prior to vaccination. The patient received ibuprofen for the events chills, body aches, headache and weakness. The patient recovered from the events chills, body aches, headache and weakness on unspecified date; while unknown outcome for the remaining events.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 23Dec2020, and nasal swab for COVID-19 test positive on 31Dec2020. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/23/2020,22.0,PVT,,,Medical History/Concurrent Conditions: Asthma; Cystitis interstitial; Hypothyroidism,,,"['Asthenia', 'Chills', 'Headache', 'Pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 954392,,,F,"maybe she could have COVID too; maybe she could have COVID too; a rash on her leg; some shortness of breath; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 06Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received her first dose of COVID-19 vaccine on Wednesday, 06Jan2021 and today, on 09Jan2021, the patient started having a rash on her leg, some shortness of breath. She used an asthma inhaler. She experienced some of the symptoms before Wednesday. The reporter was concerned that maybe the patient could have COVID, too. The reporter heard that with COVID, sometimes rashes and/or shortness of breath can come, too. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/09/2021,3.0,UNK,,,,,,"['Dyspnoea', 'Rash']",1,PFIZER\BIONTECH, 954398,NY,39.0,F,"severe headache behind the eyes; Initially extreme fatigue; started to have shortness of breath; muscle aches; cough; second dose on 05Jan2021 08:30; This is a spontaneous report from a contactable physician (patient). A 39-year-old female patient received second dose of BNT162B2 (Lot number: EL3246), intramuscularly on 05Jan2021 08:30 in left arm at single dose for COVID-19 immunization. Medical history included known allergies: latex and asthma. Patient did not have COVID prior vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), drospirenone/ethinylestradiol (YASMIN), melatonin, and ibuprofen (MOTRIN). Patient previously took montelukast sodium (SINGULAIR) and experienced allergy. Patient received first dose of BNT162B2 (Lot number: EK5730), intramuscularly on 18Dec2020 09:00 in left arm at single dose for COVID-19 immunization. Patient experienced initially extreme fatigue, then muscle ached all within 12-24 hours, severe headache behind the eyes. Then when thought was getting better, she started to have shortness of breath, worsening fatigue, and cough; all on 05Jan2021 12:00. These events were resulted in emergency room/department or urgent care. COVID was tested post vaccination. COVID test type post vaccination was nasal swab. COVID test name post vaccination was COVID 19 nasopharyngeal swan. COVID test date was on 08Jan2021. Test result was pending. Treatment received included nebulizer treatment, and steroid course. Patient was not recovered from these events.; Sender's Comments: Based on a compatible temporal relationship and known product safety profile, causality between events severe headache and extreme fatigue and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,ZOLOFT; YASMIN; ; MOTRIN [IBUPROFEN],,Medical History/Concurrent Conditions: Asthma; Latex allergy,,,"['Cough', 'Dyspnoea', 'Fatigue', 'Headache', 'Myalgia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,OT 954426,IL,43.0,F,"Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy and lightheaded/severe dizziness/felt like fainting; difficulty breathing; vomiting; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EL1285) via intramuscular route on 29Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included anxiety. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine received in four weeks. Patient hospitalized for stroke on 31Dec2020 two days after vaccine (Days of hospitalization: 4). Day of vaccine-6 hours after patient had dizzy and lightheaded for about 45 min then went away. On 31Dec2020 at 19:15 had sudden loss of hearing to right ear and severe dizziness, difficulty breathing, vomiting, and felt like fainting. Paramedics were called-sent to ER, had CTA which showed partial blockage and received TPA. Treatment included TPA, fluids, medications, hospital stay, outpatient follow ups, physical therapy. Patient was not diagnosed with COVID prior to vaccination. Patient has been tested for COVID post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: Negative and Pixel: Negative on 08Jan2021. Outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including stroke, dizzy/lightheaded/felt like fainting, difficulty breathing, vomiting, and sudden loss of hearing to right, and the administration of the COVID-19 vaccine, BNT162B2. More information regarding the patient's underlying medical conditions, relevant lab tests would be helpful for the Company to make a more meaningful causality assessment.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,12/29/2020,12/31/2020,2.0,OTH,,,Medical History/Concurrent Conditions: Anxiety,,,"['Angiogram', 'Angiogram cerebral abnormal', 'Cerebrovascular accident', 'Deafness unilateral', 'Dizziness', 'Dyspnoea', 'SARS-CoV-2 test', 'Viral test negative', 'Vomiting']",1,PFIZER\BIONTECH,OT 954434,NC,63.0,F,"fever 102 F; headache; chills; body aches; This is a spontaneous report from a contactable Nurse reported for herself. A 63-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 22Dec2020 14:30 and the second dose single dose (lot number=EK9231) on 09Jan2021 19:15 for COVID-19 immunization. Vaccine location=Left arm, dose number 1 and dose number 2. Facility-type-vaccine: Hospital. Medical history included asthma. The patient's concomitant medications were not reported. On 10Jan2021 at 14:00 the patient experienced headache with outcome of not recovered, fever 102 �F with outcome of not recovered, chills with outcome of not recovered and body aches with outcome of not recovered. The action taken was not applicable. Tylenol was received as therapeutic measures for fever.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/10/2021,19.0,PVT,,,Medical History/Concurrent Conditions: Asthma,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 954442,KY,47.0,F,Developed chest tightness around right side of chest into back and SOB 50.5 hours after vaccination. Went to local ER and found to have a right lower lobe pulmonary embolism. Treated with Xarelto and sent home with outpatient follow up.,Not Reported,,Yes,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,"Trintellix, Protonix, Singulair, Zyxal, Pulmicort, Trazodone, Melatonin",None,"Protein C deficiency (no previous h/o clots), chronic cough, hyperactive airway disease, GERD, depression/anxiety",,PCN - rash,"['Angiogram pulmonary abnormal', 'Chest discomfort', 'Dyspnoea', 'Fibrin D dimer increased', 'Muscle tightness', 'Pulmonary embolism', 'SARS-CoV-2 test negative', 'Troponin increased']",1,MODERNA,IM 954451,OR,38.0,M,"Temperature spike to 104.6; received first dose of bnt162b2 on 20Dec2020 and second dose on 08Jan2021 13:15; This is a spontaneous report from a contactable consumer. A 38-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration, on the left arm on 08Jan2021 13:15 at a single dose for COVID-19 immunization. Medical history included prediabetic kidney disease. Concomitant medications included salmo salar oil (OMEGA-3 [SALMO SALAR OIL]), lisinopril, furosemide, escitalopram, and rosuvastatin calcium (CRESTOR). The patient is reported to have received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 15:45, on the left arm, for COVID-19 immunization. The patient had no prior Covid vaccination. The patient was not tested for Covid post vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient received first dose of bnt162b2 on 20Dec2020 and second dose on 08Jan2021 13:15. On 09Jan2021 at 04:30, the patient experienced temperature spike to 104.6, brought down with TYLENOL to hover around 101.0 to 102.0 for 24 hours, normal after that. The patient called a nurse who instructed to go the emergency room/physician office visit. Outcome of the event Temperature spike to 104.6 was recovered on unspecified date in Jan2021. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,OMEGA-3 [SALMO SALAR OIL]; ; ; ; CRESTOR,,Medical History/Concurrent Conditions: Kidney disorder (Prediabetic kidney disease),,,['Body temperature increased'],2,PFIZER\BIONTECH, 954454,CT,,F,"tested positive for COVID; tested positive for COVID; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient who is a nurse visited last weekend in the reporter's home for a few hours was advised that she tested positive for COVID today (unspecified date) and her family as well. She was vaccinated recently with the Pfizer vaccine. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 954465,OK,,M,"I tested positive for COVID 8 days after my first dose.; I tested positive for COVID 8 days after my first dose.; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got his first dose of Pfizer COVID 19 vaccine 21 days ago in Dec2020. He mentioned that he tested positive for COVID 8 days after his first dose in Dec2020. He stated that he got the second dose yesterday (unspecified date) and queried if should he not have gotten it. The outcome of the events was unknown. Information about Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 954466,PA,34.0,F,"9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nausea, vomiting 10th: profound fatigue, hives, intermittent vertigo 11-17th: vertigo, mild headache and neck pain, nausea, vomiting 18th-current: vertigo, nausea, vomiting *Hospitalized from 17-18th, diagnosed with vestibular neuritis secondary to the vaccine",Not Reported,,Not Reported,Yes,1.0,Yes,N,01/08/2021,01/09/2021,1.0,PVT,Multivitamin,None,None,,None,"['Angiogram', 'Arthralgia', 'Computerised tomogram head', 'Electrocardiogram', 'Fatigue', 'Feeling cold', 'Full blood count', 'Headache', 'Magnetic resonance imaging brain', 'Metabolic function test', 'Nausea', 'Neck pain', 'Pain', 'Pregnancy test', 'Restlessness', 'Troponin', 'Urticaria', 'Vertigo', 'Vestibular neuronitis', 'Vomiting']",2,PFIZER\BIONTECH,IM 954470,GA,,M,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable 39-year-old male healthcare professional reported to have received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Jan2021, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Jan2021, after the first dose of vaccine, the patient felt sick at some point, so he took a rapid test which came back positive. He stated that the test if testing the antigens (as reported). Antibody testing was not currently recommended to assess for immunity to COVID-19 following Pfizer-BioNTech COVID-19 vaccination. Events outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/01/2021,,UNK,,,,,,"['Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 954471,,,U,"13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is first of 13 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018408 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018409 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018410 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018411 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018412 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018413 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018414 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018415 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018416 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018417 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018418 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018419 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018410 same reporter, similar suspect drug and event; different patient.;US-PFIZER INC-2021018412 same reporter, similar suspect drug and event; different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Coronavirus test positive'],UNK,PFIZER\BIONTECH, 954476,FL,,U,"After getting the first shot and the patient test positive for Corona virus; After getting the first shot and the patient test positive/perhaps positive; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable pharmacist reported that a patient of unspecified age and gender started to receive BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, first dose on an unspecified date at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. A pharmacist in a hospital wanted to know if after getting the first shot and the patient test positive for Corona virus, how long do they have to wait to get the second? A colleague is perhaps positive. He doesn't know if they got tested. Outcome of the events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between reported event and BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PVT,,,,,,"['Adverse event', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 954479,CA,51.0,F,"Tested positive for COVID; Tested positive for COVID; Phlegm in throat; Cough; Runny nose; cold; Sneezing; Body aches; Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 14:50 at single dose at right arm for covid-19 immunization. No additional vaccines administered on the same date. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included ongoing migraine. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN EXTRA STRENGTH) for migraine, patient had been alternating this with paracetamol (TYLENOL) while she has been recovering. She clarified the symptoms she experienced as the same day she got the vaccine that evening she had a headache on 29Dec2020. It eventually became a migraine and she left work early. On 30Dec2020 she had body aches, little nausea, and chills. On 31Dec2020, she had more chills, a runny nose, she felt like she was coming down with a cold. She was sneezing, had more chills, more body aches. On 01Jan2021 she felt like she noticed she had phlegm in her throat, but she did not have any pain. The phlegm was causing her to cough more. She had a runny nose the next morning as well. She did the rapid test for COVID on 02Jan2021 evening, and it was positive. She had a headache almost every day. The body aches had pretty much worn off. Runny nose and sneezing resolved in Jan2021. Phlegm in throat confirmed with no pain. This also resolved, as well as coughing. Outcome of event tested positive for COVID was unknown, outcome of event headache was not recovered. outcome of event nausea was recovered on 07Jan2021, event chills was recovered on 08Jan2021, outcome of other events was recovered on unspecified date in Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Information of lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,EXCEDRIN EXTRA STRENGTH,Migraine,,,,"['Chills', 'Condition aggravated', 'Cough', 'Headache', 'Impaired work ability', 'Malaise', 'Migraine', 'Nausea', 'Pain', 'Productive cough', 'Rhinorrhoea', 'SARS-CoV-2 test positive', 'Sneezing']",1,PFIZER\BIONTECH, 954482,NC,,M,"Positive COVID test; Positive COVID test; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for 2 patients. This is the 2nd of 2 reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was an Odontist and received COVID vaccine on Monday. He was scheduled to have a cath done on Thursday, but that was not happening now. The patient has positive COVID test. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021013678 same reporter/drug, similar event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 954486,AZ,51.0,F,"Her stomach is still weirded out/sour stomach; feeling sick; arm pain; She was sick to her stomach; kidneys were hurting; body aches; tested positive; tested positive; The arm wasn't swollen it was just burning.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. At first, she thought she was having a reaction, but then she started feeling sick so she got tested. She was positive so she wasn't having a reaction. She was scared from the pain of COVID. She experienced sickness. Her stomach was still weirded out. She did experience arm pain from the vaccine. Her doctor told her it was fine that it needed to air out. She left the bandage on too long. She didn't have a prescribing doctor. She received the vaccine on the 29Dec2020. She tested positive 02Jan2020. The arm wasn't swollen it was just burning. She was sick to her stomach when she got the stomach. The sick to the stomach lasted maybe two days, but then she got COVID. The burning was around the arm. It wasn't that bad. It lasted for a day. It started the day she got the shot (on the 29Dec2020). On 07Jan2021, she went to the hospital because her kidneys were hurting. The doctor said her kidneys were good. They did labs which were good. She was still going through body aches. She was told she was currently in the worst part of the virus. She still had a sour stomach going on from the virus as well. The outcome of the body aches and sour stomach was not recovered, for other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Burning sensation', 'Dyspepsia', 'Gastric disorder', 'Illness', 'Laboratory test normal', 'Malaise', 'Pain', 'Pain in extremity', 'Renal pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 954489,TN,27.0,F,"tested positive after receiving the vaccine; tested positive after receiving the vaccine; she did not think symptoms were related to COVID like leg pain. She noticed that it was a lot worst; she did not think symptoms were related to COVID like leg pain. She noticed that it was a lot worst; This is a spontaneous report from a contactable consumer (patient herself). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. EH9899 and expiry date Mar2021), via an unspecified route of administration on 05Jan2021 on her left arm at a single dose for covid-19 immunization. Medical history included leg pain. There was no reported concomitant medications. On an unspecified date, patient received COVID vaccine. She stated that she was symptomatic during the vaccine and somewhere after confirmed that she was COVID-positive. She wanted to know if there are any health concerns with getting the vaccine while COVID positive. She added that this was her first dose. she did not think symptoms were related to COVID like leg pain. She noticed that it was a lot worst but did not think that it was a symptom. She stated that she does not recall the first time ever that she had leg pain but stated that the leg pain was really bad the night before the vaccine. She added that she was isolated until 14Jan2021. Outcome of the events drug ineffective, COVID-19 virus test positive and leg pain were unknown.; Sender's Comments: Leg pain is considered intercurrent and unrelated to suspect BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Leg pain,,,"['Pain in extremity', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 954495,CT,,F,"COVID-19 or flu-like symptoms following COVID-19 vaccination/COVID-19 results were to be positive; COVID-19 or flu-like symptoms following COVID-19 vaccination/COVID-19 results were to be positive; COVID-19 or flu-like symptoms following COVID-19 vaccination; This is a spontaneous report from a contactable Other-HCP. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On unspecified date, COVID-19 or flu-like symptoms following COVID-19 vaccination was reported for the patient. COVID-19 results were to be positive on unspecified date. Changing diet to vegan was reported. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Influenza like illness', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 954497,,,U,"contracted COVID two days after receiving vaccine; contracted COVID two days after receiving vaccine; This is a spontaneous report from a non-contactable nurse. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got their first dose of the COVID vaccination. The patient contracted COVID on an unspecified date two days after receiving the vaccine. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch could not be obtained. No further information is expected.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 954511,,,F,"tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program Pfizer Connect. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient works for a hospital. Said had 1st dose of vaccine. Had tested positive for covid on an unspecified date and is under quarantine. The patient would like to know when she should get 2nd dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown. Information on the lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 954512,SC,,U,"got sick and tested positive with COVID; got sick and tested positive with COVID; This is a spontaneous report from a contactable consumer via Pfizer Sponsored Pfizer First Connect. A contactable consumer reported similar events for four patients. This is second of four reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got sick and tested positive with covid on an unspecified date. It was further reported that patient who received the COVID vaccine, tested positive for COVID, and experienced side effects afterwards. The outcome of the events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021013589 same drug, similar events, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Malaise', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 954514,SC,,U,"got sick and tested positive with COVID; got sick and tested positive with COVID; This is a spontaneous report from a contactable consumer via Pfizer Sponsored Pfizer First Connect. A contactable consumer reported similar events for four patients. This is fourth of four reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got sick and tested positive with covid on an unspecified date and experienced side effects afterwards. The outcome of the events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021013589 same drug, similar events, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PVT,,,,,,"['Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 954515,SC,,U,"got sick and tested positive with COVID after getting the first dose of the COVID vaccine; got sick and tested positive with COVID after getting the first dose of the COVID vaccine; This is a spontaneous report from a contactable consumer received from Pfizer-sponsored program Pfizer First Connect. This consumer reported similar events for four patients. This is 3rd of four reports. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got sick and tested positive with COVID after getting the first dose of the COVID vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021013589 same reporter, same product, similar events, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 954520,CA,,F,caller tested positive on covid a week after taking the 1st dose of vaccine; caller tested positive on covid a week after taking the 1st dose of vaccine; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program Pfizer First Connect. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient was tested positive for Covid a week after taking the 1st dose of vaccine on an unspecified date. The outcome of events was unknown. Patient wanted to know if she can get the second dose. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 954536,WA,,M,"COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a Pfizer-sponsored program ""Pfizer First Connect"" from a contactable consumer reporting for himself. A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on 22Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 virus test positive on an unspecified date with outcome of unknown. It was reported that the patient was scheduled to get his second dose on 12Jan2021, however between 22Dec2020 and 12Jan2021 the patient experienced the adverse event. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 954540,,,F,"Got the first dose and was contracted with COVID; Got the first dose and was contracted with COVID; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was contracted with covid on an unspecified date in Dec2020 (27Dec2020 or 28Dec2020) with outcome of unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/01/2020,,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 954541,CO,,F,"throat swelling; headache; Pain; little bit of chills; GI upset; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EK9231, expiry: 30Apr2021), via an unspecified route of administration on an unspecified date at 0.3 mL, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of bnt162b2 on an unknown date for covid-19 immunization and experienced pain at the injection site. On an unspecified date, the patient experienced head ache, throat swelling, gastrointestinal (GI) upset, pain, and little bit of chills (don't believe to have had fever). It was clarified that the event took place after use of product. The outcome of the events was unknown.; Sender's Comments: The information in this report is limited, and does not allow a full medically meaningful assessment of the case. Considering temporal relationship, a causal relationship between the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) and the reported events including throat swelling cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Abdominal discomfort', 'Chills', 'Headache', 'Injection site pain', 'Pain', 'Pharyngeal swelling']",UNK,PFIZER\BIONTECH, 954560,,,U,"five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; This is a spontaneous report from a contactable nurse. This nurse reported similar events for five patients. This is the first of five reports. A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, on an unspecified date, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. It was reported that five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID on an unspecified date. They would like to know if they still get the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Covid-19 virus test positive and suspected LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021021909 Same reporter/ drug/ event for different patients.;US-PFIZER INC-2021021910 Same reporter/ drug/ event for different patients.;US-PFIZER INC-2021021911 Same reporter/ drug/ event for different patients.;US-PFIZER INC-2021021912 Same reporter/ drug/ event for different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 954561,,,U,"five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; This is a spontaneous report from contactable nurse. This nurse reported similar events for 5 patients. This is the second of five reports. A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, on an unspecified date, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. It was reported that five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID on an unspecified date. They would like to know if they still get the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.,Linked Report(s) : US-PFIZER INC-2021021881 Same reporter/ drug/ event for different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 954563,,,U,"five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; This is a spontaneous report from a contactable nurse. This nurse reported similar events for five patients. This is the third of five reports. A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not reported), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. It was reported that five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID on an unspecified date. They would like to know if they still get the second dose. Outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.,Linked Report(s) : US-PFIZER INC-2021021881 Same reporter/ drug/ event for different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 954568,,,U,"five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; This is a spontaneous report from a contactable nurse. This nurse reported similar events for five patients. This is the fourth of five reports. A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, on an unspecified date, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. It was reported that five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID on an unspecified date. They would like to know if they still get the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.,Linked Report(s) : US-PFIZER INC-2021021881 Same reporter/ drug/ event for different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 954569,,,F,"five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; she had felt weird; This is a spontaneous report from a contactable nurse. This nurse reported similar events for five patients. This is the fifth of five reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse reported on behalf of her sister (patient). It was reported that the patient called right before Christmas and she had gotten the Pfizer COVID Vaccine. She reported that she had felt weird and had side effects to the vaccine. The patient works in a nursing home type thing, and she said she has had people who have gotten the first dose of the vaccine, and then tested positive for COVID. The patient called to ask the reporter if they should still get the second dose. The only other details that her sister (patient) provided her was that this has happened with several people; 5 employees and several or 9 patients. She is unsure if she said several patients or 9 patients, but there were 5 employees. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021021881 Same reporter/ drug/ event for different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Feeling abnormal', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 954576,AR,44.0,F,"Diarrhea; nausea and vomiting; nausea and vomiting; rash on her right arm, like a hive or whelp; Fever; Headache; really sore right arm; right arm felt numb; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (Pfizer COVD 19 vaccine), lot number: EL0142, via an unspecified route of administration on 07Jan2021 17:00 at single dose in right arm for COVID-19 immunisation. Medical history included blood pressure abnormal, had a cough from having COVID 19 on 16Dec2020, cough was ongoing and unknown for COVID-19. Concomitant medication included amlodipine from an unspecified date (taking for 2 years) and ongoing at 10mg once daily by mouth for blood pressure abnormal. No other vaccines were administered on same date and no prior vaccinations (within 4 weeks). Registered nurse (patient) was calling regarding Pfizer COVID 19 vaccine. Reported she received the first dose last Wednesday 07Jan2021 17:00 in the right arm. Reported she noticed the next day (08Jan2021) fever and a headache. On 08Jan2021, Friday she had a really sore right arm and her right arm felt numb. On 09Jan2021, Saturday, she experienced nausea and vomiting and also noticed a rash on her right arm, like a hive or whelp. On 10Jan2021 Sunday, again with the fever, nausea, vomiting and she had diarrhea. Today she stated she woke up a new woman. She feels felt with no fever and her arm was better. She still had a cough from having COVID 19 on 16Dec2020. Stated she was used to coughing. Added she treated the fever with Tylenol 1000mg. Stated she didn't remember exactly but she took a little everyday starting on Thursday the day after the vaccine. Stated she was unsure if she would have the next dose. The events didn't require a visit to physician office or emergency room. The outcome of fever was recovered on 10Jan2021, of Headache, sore arm, rash on right arm, nausea and vomiting was recovered on 11Jan2021, of arm numb was recovered on 09Jan2021, of diarrhea was recovering. Serious criteria for fever was reported as yes, medical significant, for Headache, sore arm, arm numb and Diarrhea was non-serious, for rash on right arm, nausea and vomiting was unspecified.; Sender's Comments: Based on the compatible time association, the event fever is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,,Cough,Medical History/Concurrent Conditions: Blood pressure abnormal; COVID-19,,,"['Cough', 'Diarrhoea', 'Headache', 'Hypoaesthesia', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Rash', 'Urticaria', 'Vomiting']",1,PFIZER\BIONTECH, 954585,,,U,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient develop Covid-19 diagnosed by PCR about may be six or seven days after received the vaccine. The patient recovered from the event. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 954604,AZ,,U,"after the patient got vaccinated his relative tested positive; after the patient got vaccinated his relative tested positive; This is a spontaneous report from a Pfizer-sponsored program . A contactable nurse (relative of the patient) reported for a patient of unspecified age and gender received the first dose of bnt162b2 (also reported as Pfizer Covid-19 Vaccine, lot no. and expiry date was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse called in because his relative got the 1st dose of vaccine but after the patient got vaccinated his relative tested positive on unspecified date. The nurse called in if the patient can take the 2nd dose of vaccine. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) but after the patient got vaccinated his relative tested positive on unspecified date. The case will be reassessed should additional information become available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 954611,NY,,M,"Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable nurse (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. The patient received his first dose on 22Dec2020 then, nine days later, on 31Dec2020, he tested positive for COVID. He is scheduled for his second dose on 12Jan2021. However, he is still out of work. He called to see if he could get his second dose a couple of days later or does it have to be exactly 3 weeks from the first shot and if it is okay to go a little longer. During the call, he stated he just wanted his question answered about the second shot, if can he wait a little longer. The outcome of the events was unknown. Follow-up attempts are completed. The following information on the batch number has been requested.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/31/2020,9.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 954619,,,U,"Got my Covid vaccine on the 20th and then I came back positive for Covid last week; Got my Covid vaccine on the 20th and then I came back positive for Covid last week; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 20Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the COVID vaccine on the 20th (20Dec2020) and then came back positive for COVID on an unspecified in Jan2021 (reported as last week), then tested negative on 08Jan2021 and was due for vaccine on 09Jan2021. It was asked if the patient will be able to get the vaccine. The outcome of the events was recovered on 08Jan2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/20/2020,01/01/2021,12.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 954620,KY,,U,"diagnosed with Covid; diagnosed with Covid; This is a spontaneous report from contactable other healthcare professional via a Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date was not reported) via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the vaccine on 04Jan2021 and was diagnosed with COVID on 07Jan2021. Outcome of the event was unknown. Information about Lot/Batch number has been requested.; Sender's Comments: Although, BNT162B2 vaccine immunogenicity is not in full effect after short time (3 days in this case) from the first dose administration, a causal relationship between event ""diagnosed with COVID"" (coded to Drug ineffective / COVID-19) and BNT162B2 vaccine cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/07/2021,3.0,OTH,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 954629,,,U,"Patient received 1st dose on 28Dec and presented symptoms on 05Jan; Patient received 1st dose on 28Dec and presented symptoms on 05Jan; This is a spontaneous report from a contactable pharmacist reporting for self via Pfizer field representative (Field Medical Director). A patient of unspecified age and gender received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not reported) on 28Dec2020 via an unspecified route of administration for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient presented COVID-19 symptoms on 05Jan2021. No lab tests reported. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 28Dec2020, and patient presented COVID-19 symptoms on 05Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, patient's COVID-19 symptoms on 05Jan2021 likely represents a pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/05/2021,8.0,UNK,,,,,,['Adverse event'],1,PFIZER\BIONTECH, 954668,,,M,"This morning he is diabetic. His sugar it was elevated, it was up to 300 which is he said much higher than normal; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program Pfizer First Connect. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. He has his first dose of the COVID Vaccine yesterday and this morning he is diabetic. When he woke up this morning to test his sugar it was elevated, it was up to 300 which is he said much higher than normal and wants to know if that would be a symptom. Outcome of event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/10/2021,1.0,UNK,,,,,,['Blood glucose increased'],1,PFIZER\BIONTECH, 954679,,,F,"Alzheimer's diease from 40 year's of flu vaccines; Initial information received on 06-Jan-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional . This case involves Adult female patient (unspecified age) who had alzheimer's diease from 40 year's of flu vaccines (dementia allzheimer's type), while she received vaccine INFLUENZA VACCINE. The medical treatment(s), vaccination(s) and family history were not provided. The patient had no medication details and reason for taking the medicine, medical history, concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious alzheimer's diease from 40 year's of flu vaccines (dementia alzheimer's type) unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. There were no lab data and results available. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event was not recovered. Information on lot number was requested for this case.; Sender's Comments: This case concerns a female patient (unspecified age) who had dementia alzheimer's type after vaccination with INFLUENZA VACCINEs over 40 years. The time to onset is unknown. The patient had no reported medical history, concomitant disease or risk factor at the time of vaccination. There were no lab data/results available excluding other predisposing etiologies for complete assessment of the case. Based upon the reported information, the role of the suspect vaccinations cannot be assessed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"[""Dementia Alzheimer's type""]",UNK,UNKNOWN MANUFACTURER,OT 954694,NY,,M,"shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, strength, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of shingles was considered to be not recovered and causal relationship was assessed as related. The lawyer considered the event of shingles to be disability.",Not Reported,,Not Reported,Not Reported,,Yes,N,,,,UNK,,,,,,['Herpes zoster'],UNK,MERCK & CO. INC.,OT 954720,MD,41.0,M,"1/16/21, Covid vaccine injection at 12:09 PM Minute 1: dizzy and light headed (like drinking a beer on an empty stomach) Minute 10: Nausea Minutes 23-25: Neck tightness (like doing unsupported crunches and holding my head up) Minute 27: Inability to swallow and inability to speak EMS on site administered EpiPen auto-injection to left thigh, immediate improvement in symptoms Transport to hospital via ambulance Hospital monitored me for several hours and discharged same day",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/16/2021,01/16/2021,0.0,PUB,"Testosterone, Anastrozole, Crestor, Lisinopril, Aspirin, Multivitamin, Vitamin C, Vitamin D, Zetia",None,"Sleep apnea, CAD, pituitary microadenoma",,"None known, seasonal allergies only","['Aphasia', 'Dizziness', 'Dysphagia', 'Laboratory test normal', 'Muscle tightness', 'Nausea']",1,PFIZER\BIONTECH,IM 954723,NY,56.0,F,"itching, hives, short of breath, numbness and tingling to lips with hives to bottom. headache.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,WRK,multi viamin,pancreatitis,"gerds, hernia, asthma",,"pineapple, bee sting","['Dyspnoea', 'Headache', 'Hypoaesthesia oral', 'Paraesthesia oral', 'Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,IM 954780,MI,82.0,M,"On 1/13/2021, resident had sudden emesis. Immediately following emesis he was noted without a pulse and pronounced deceased. No acute symptoms noted prior to this episode. Resident does have a significant cardiac history.",Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/13/2021,8.0,SEN,Norvasc 10mg daily Multivitamin daily Vitamin C 500mg twice daily Folic Acid 1mg daily Aspirin 81mg daily Thiamine 100mg daily Coreg 6.25mg twice daily Ativan 0.5mg three time daily Cymbalta 30mg daily ProStat 30ml three time daily D,None,Essential Hypertension Anxiety Disorder Unspecified Convulsions Pulmonary Candidiasis Paroxysmal atrial fibrillation Occlusion and stenosis of carotid arteries Congestive Heart Failure Left below the knee amputation Peripheral Vascular Disease Hypokalemia Urinary Retention,,Shellfish/Seafood,"['Death', 'Pulse absent', 'Vomiting']",1,MODERNA,IM 954804,MA,48.0,F,"Started with severe chills, body aches and feverish. The. Slight leg pain which worsened with time , swelling on the right leg calf, warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in the hospital now.",Not Reported,,Yes,Yes,4.0,Not Reported,N,01/08/2021,01/10/2021,2.0,WRK,Mvi and vitamin C,None,None,,Acetaminophen,"['Blood test', 'Chest X-ray', 'Chills', 'Computerised tomogram', 'Dyspnoea', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pulmonary embolism', 'Pyrexia', 'Skin warm', 'Thrombosis', 'Ultrasound scan']",1,MODERNA,IM 954812,NY,86.0,F,"She had the first dose of Pfizer vaccine at the Campus on Friday 1/15 at 4:30 pm. After the vaccine, she had no new symptoms or signs of vaccine reaction and MD friend reports that he checked her pulse which was not elevated from baseline. On 1/16, she awakened and continued to feel at her recent baseline. However, in the early afternoon, she complained of headache, nausea/epigastric pain, and chest heaviness. These apparently were not unusual symptoms for her to feel intermittently. Per her niece, who has a home O2 sat device, her 02 sat that morning was 97 with a HR of 87 irregularly irregular. She was afebrile. (continue on page 2)",Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,,01/15/2021,01/16/2021,1.0,PVT,"apixaban, levothyroxine, prednisone, diltiazem, (cont page 2)",Unknown,"non stentable distal occlusive disease, coronary heart disease, stroke, heart failure, diabetes mellitus, (cont. p 2)",,NKDA,"['Abdominal pain upper', 'Cardiac arrest', 'Chest discomfort', 'Headache', 'Heart rate irregular', 'Nausea', 'Pulseless electrical activity', 'Syncope']",1,PFIZER\BIONTECH,IM 954837,MA,20.0,F,"Caller state that first vaccine 12/22 caused fever 100.0, fatigued, muscle aches, pain in arm pit on the vaccinated arm.. Caller went to doctor diagnosed with swollen lymph nodes lasting 12 days. Second Vaccine 1/12 caused high fever, headache, muscle aches and fatigue. Caller used Tylenol and went to be tested for corvid and results were negative. Caller stated that she still does have some numbness in the hand with the swollen lymph nodes. Caller completed vaers report over phone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,WRK,"albuterol, Zyrtec and Tylenol prn",none,asthma,Flu shot years ago caused severe headaches,none,"['Axillary pain', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Lymphadenopathy', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 954943,GA,88.0,F,"Aphasia, ,right-sided weakness and garbled speech",Not Reported,,Not Reported,Yes,2.0,Yes,N,01/07/2021,01/17/2021,10.0,PVT,Vitamin D2000 1 tablet qd,"Sarcoidosis, Hyperlipidemia, Restless legs, Vitamin D, Insomnia, Episodic tension-type headache ,","Intervertebral disc disorders with myelopathy , lumbar region",,none,"['Aphasia', 'Cerebrovascular accident', 'Dysarthria', 'Hemiparesis', 'Magnetic resonance imaging brain abnormal']",1,MODERNA,IM 954996,IN,34.0,F,"Had severe body aches m, fever, headache, progressed into dizziness and ""foggy memory"", started to have some chest pain. Felt as if I was intoxicated, lasted the whole day. Woke up the next morning and still felt ""out of it"" and weak but thought it would get better, went to work (im a nurse). Started having continous vomiting, shortness of breath and chest pain at work. As well as severe tremors. I was taken to the hospital, given fluids and my QT was prolonged with my heart which i have never had before . Was given iv magnesium and waited for my heart rhythm to improve. Was told not to take anymore of my prescribed medications or nausea medications and follow up with my pcp the next day. Im still feeling horrible, nausea, body aches, low grade fever and I am 72 hours out. Now I have huge hospital bill to pay, can't work currently because I still feel bad and my heart has a weird rhythm. Hoping this helps as if this was what I was expecting I would have never got it.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/16/2021,01/17/2021,1.0,PVT,"Prozac, amytriptiline, Zofran, methylphenidate, melatonin, multivitamin, emergency c, vit d",None,N/a,,Macrobid,"['Asthenia', 'Chest X-ray', 'Chest pain', 'Computerised tomogram', 'Dizziness', 'Dyspnoea', 'Electrocardiogram QT prolonged', 'Feeling abnormal', 'Feeling drunk', 'Headache', 'Heart rate irregular', 'Impaired work ability', 'Laboratory test', 'Memory impairment', 'Nausea', 'Pain', 'Pyrexia', 'Tremor', 'Vomiting']",UNK,PFIZER\BIONTECH, 955012,FL,71.0,F,"Pt complained at ED of Headache, Nausea, SOB, felt like had been running. Pt in AFIB started on cardizem admitted to hospital 1/15 discharged 1/17",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/14/2021,01/15/2021,1.0,PUB,"zinc 220, dexamethasone 4mg, bacid caplet, azithromycin, atorvastatin, montelukast, amitriptyline, warfarin, ascorbic acid, cholecalciferol,",discharged from hospital 1/1/21 for COVID 19,none listed,,Penicillin,"['Atrial fibrillation', 'Dyspnoea', 'Electrocardiogram ST segment abnormal', 'Headache', 'Nausea']",1,MODERNA,IM 955052,MD,85.0,F,Patient tested positive for COVID 19 on Jan 5th 2021 Patient was admitted to the hospital January 9th for pneumonia due to COVID,Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,12/31/2020,01/05/2021,5.0,PVT,,,,,amlodipine fluconazole macrolides paxil tetracycline erythropoietin analogues,"['COVID-19 pneumonia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 955096,KY,50.0,F,Acute liver injury requiring transplant evaluation and acute kidney injury,Not Reported,,Yes,Yes,2.0,Not Reported,N,01/01/2021,01/16/2021,15.0,OTH,Bactrim Acetaminophen,None,None,,None,"['Acute kidney injury', 'Liver injury', 'Transplant evaluation']",UNK,PFIZER\BIONTECH, 955179,TN,79.0,F,"Two days after her shot, she was sitting down working on her computer paying bills. She became nauseas and dizzy and then fainted. She hit the tile floor.",Not Reported,,Not Reported,Not Reported,,Yes,Y,01/02/2021,01/04/2021,2.0,PUB,"Morning: Lexapro 10 mg, Losartan/HCT 100/12.5/, atoruastatin 20 mg/calcium, Escital Opram 5mg, Evening: omaprazole 20 mg, procilosac, amlicdpine destylate 5 mg, montelakast sodium 10 mg, baby asprin Day and night: dymista 23 mg spray, Tro",None,Allergies,,"Sulfa,latex, lovaquin","['Computerised tomogram head abnormal', 'Dizziness', 'Facial bones fracture', 'Fall', 'Nausea', 'Syncope']",UNK,MODERNA,SYR 955194,OK,60.0,F,"Lot number for the first dose was EK5730. After receiving the 2nd dose on the 01/11/2021 went to lunch and in the evening started feeling nausea and was throwing and abdominal pain. Went to work sick Tuesday and Wednesday low grade fever, nausea and abdominal pain, wasn't eating was to sick to eat. Thursday early morning hours the pain was unbearable so she went to the ER and the cat scan. It was determined that she had appendicitis and they removed my appendix same day. Feels so much better now.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/21/2020,01/11/2021,21.0,PUB,"Vitamin D daily, Zinc daily, Valtris 500mg daily, Olmesartan 40 mg daily, Calcium. Magnesium, when she remembers",,high blood pressure but very mild case,,"Sulfur, morphine, fentanyl,","['Abdominal pain', 'Appendicectomy', 'Appendicitis', 'Blood test normal', 'Computerised tomogram abnormal', 'Decreased appetite', 'Malaise', 'Nausea', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 955231,CO,89.0,M,"After receiving Moderna vaccine, pt became increasingly tired, withdrawn, and confused, refusing to walk at home. He has begun to have mild memory changes after suspected COVID illness (covid testing negative) in November, but daughter of patient, with whom he lives, states that his memory and orientation now significantly changed- he seems to have forgotten the last ""3 years"" of memory. Presented to ER 1/16/21 as she checked his O2 and found him to be hypoxic in 60s. He is being treated for possible CAP with underlying perviously undiagnosed ILD vs post-covid lung changes (per pulmonology), and his energy and ability to walk have returned but memory is significantly impaired, confabulating and oriented only to self despite good oxygenation on 5L O2 by NC.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/12/2021,01/13/2021,1.0,PVT,"Metformin, glyburide, actos, losartan, simvastatin",,"Diabetes, uncontrolled Suspected COVID infection (but testing Negative) in November- febrile illness with diarrhea/fatigue/cough/hypoxia requiring 2 L O2- treated w/ steroids and abx for possible pneumonia. O2 requirement lasted 2 weeks",,none,"['Acute kidney injury', 'Amnesia', 'Anaemia of chronic disease', 'Angiogram pulmonary abnormal', 'Blood culture negative', 'Blood folate normal', 'Blood thyroid stimulating hormone normal', 'Cerebral small vessel ischaemic disease', 'Condition aggravated', 'Confabulation', 'Confusional state', 'Disorientation', 'Fatigue', 'Gait disturbance', 'Hypoxia', 'Interstitial lung disease', 'Lung opacity', 'Magnetic resonance imaging brain abnormal', 'Mediastinal disorder', 'SARS-CoV-2 test negative', 'Social avoidant behaviour', 'Vitamin B12 normal', 'Vitamin D decreased']",1,MODERNA,IM 955247,NY,74.0,F,"About 22 hours after the shot, I had a mini stroke that required going to the emergency room by ambulance. I was transported that evening to the stroke division that same evening for further evaluation, tests and care. I have never had a mini stroke before this.The doctors said it may have been from the vaccination, or it may not have been precipitated by it. They said they don't have enough information on the Moderna vaccine to make that call.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/14/2021,01/15/2021,1.0,PUB,"Vitamin D, 2000 IU Calcitriol, 0.25 MCG Vitamin C, 250 MG",CKD stage 3,"Osteopenia, CKD stage 3 Asthma",,"Penicillins, Erthromyacin, sulfa drugs Dust, cats, mold","['Chest X-ray', 'Computerised tomogram abdomen', 'Computerised tomogram thorax', 'Magnetic resonance imaging brain', 'Scan with contrast', 'Transient ischaemic attack', 'X-ray limb']",1,MODERNA,IM 955261,MD,85.0,F,Death,Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/19/2021,1.0,SEN,"Nystatin, vitamin C, Klor Con, Vit B12, Coreg, Lactulose, simethicone, colace, trazodone, multi vitamin, torsemide, miralax, calcium, pantoprazole, breo ellipta,","Hip fracture,","afib, hyperlipidemia",,"darvocet, toradol",['Death'],UNK,PFIZER\BIONTECH,IM 955306,SD,40.0,M,"Received vaccination on 12/30/2020, had positive Covid test result on 1/6/2021, was hospitalized with respiratory issues on 1/11/2021, and discharged home from the hospital on 1/18/2021",Not Reported,,Not Reported,Yes,7.0,Not Reported,U,12/30/2020,01/06/2021,7.0,PVT,,,Asthma,,Multiple allergies,"['Respiratory disorder', 'SARS-CoV-2 test positive']",1,MODERNA,IM 955374,CA,37.0,F,"Felt tachycardia immediately, thought she was anxious. After 35-45 minutes she felt like she was having a hard time swallowing which progressed to tongue swelling, all taste buds popped up and sore, hives on face & neck, reddened face. Itchy neck and face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling all over body. Woke up feeling heaviness as if she had ""sumo wrestler"" on her body. 24 hours post vaccine heaviness started to lift but felt as if she had a vise on her lungs. Continuing to take Atarax every 6 hours per MD order.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,PVT,"IBU, plaquenil stopped approximately 3 weeks prior to vaccine.",,"Lupus, asthma, allergies, migraines",red hot swollen with the flu shot that has preservatives,"shellfish or anything shellfish derived any fish- anaphylaxis, Imitrex- stroke like reaction, mustard - rash and tongue raw, PCN, Erythromycin, amoxicillin - rash and hives, codeine - airway narrowed, Benadryl - secondary rash, sulfa - anaphylaxis.","['Anxiety', 'Chest discomfort', 'Discomfort', 'Dysphagia', 'Erythema', 'Fatigue', 'Glossodynia', 'Hypertrophy of tongue papillae', 'Immediate post-injection reaction', 'Pruritus', 'Swelling', 'Swollen tongue', 'Tachycardia', 'Urticaria']",1,PFIZER\BIONTECH,IM 955390,AL,95.0,F,"Resident received vaccination on January 15, 2021. She was found unresponsive with shallow respirations on the morning of January 16, 2021 and was sent to ER via ambulance. The resident was admitted to medical center ICU where she passed away later that day.",Yes,01/16/2021,Not Reported,Yes,1.0,Not Reported,N,01/15/2021,01/16/2021,1.0,SEN,unknown,unknown,unknown,,unknown,"['Death', 'Hypopnoea', 'Intensive care', 'Unresponsive to stimuli']",UNK,PFIZER\BIONTECH,IM 955425,MN,90.0,M,"resident had a pressure ulcer to RT hip, was getting treatment on. Was scheduled to have wound debrided and wound vac applied on 1-19-2021. Appetite was poor, not wanting to get out of bed, and decline in alertness. Passed away on 1-16-2021",Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/15/2021,10.0,SEN,"amlodipine, aricept, bactrim, namenda, remeron",pressure ulcer,"alxheimer's, depression, vitamin D deficience, BPH",,PCN,"['Death', 'Decreased appetite', 'Depressed level of consciousness']",1,MODERNA,IM 955432,PA,33.0,F,"I had vaginal bleeding and receive a Ultra sound. Which I had a miscarriage. My estimated delivery was August 25,2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/14/2021,4.0,PVT,Prenatal vitamin,None,None,,None,"['Abortion spontaneous', 'Activated partial thromboplastin time', 'Exposure during pregnancy', 'Ultrasound scan abnormal', 'Vaginal haemorrhage']",2,PFIZER\BIONTECH,IM 955434,NC,50.0,F,"I got flushed and hot, I got very nauseous. I thought I was going to vomit and dizzy and laid on bathroom floor. I then got up and laid on bed and got headaches and chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,None reported,"I was diagnosed wiith Covid on 11-27-2020, still having some side effects like a bad cough.",None reported,,Amoxycillin,"['Chest X-ray', 'Chills', 'Dizziness', 'Feeling hot', 'Flushing', 'Headache', 'Nausea']",1,MODERNA,IM 955436,,84.0,M,patient received vaccine 12/29. Unexpected death 1/5.,Yes,01/05/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/05/2021,7.0,UNK,aspirin atorvastatin bumetanide carvedilol vit d 3 miralax tamsulosin tylenol keppra lisinopril mirtazapine pantoprazole senna,"CAD s/p CABG, prior ischemic HFpEF (EF 45% > 50%), mild-mod Mitral Stenosis, bradycardia s/p PPM, HTN, HLD, DMII (A1C 6.5), CKD (baseline Cr 2-2.5), GERD, BPH, seizure disorder (on keppra)",as above,,none,['Death'],1,PFIZER\BIONTECH,IM 955467,,46.0,F,Patient had received second Pfizer vaccination after no reported issues with the first dose. Patient was observed post vaccination without incident and released. Patient developed wheezing and attempted to treat with her albuterol inhaler but did not improve. patient presented to the ED approximately 2 hours after vaccination and was admitted for respiratory failure and placed on BiPAP for a brief period of time. patient has known history of Asthma Exacerbation requiring hospitalization and intubations. D/C diagnosis Asthma Exacerbation,Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/13/2021,01/13/2021,0.0,PVT,Prednisone Spirva HHN Albuterol Singular Xarelto,Acute Asthma Chronic Bronchitis Severe Obesity Diabetes,Anemia [D64.9] Asthma [J45.909] Chronic bronchitis (HCC) [J42] Diabetes secondary to steroid DVT (deep venous thrombosis) right leg PERSONAL HISTORY OF DISEASE blood in urine Pneumonia [J18.9] Sleep apnea [G47.30] had test done in 2018 and was cleared STEROID THERAPY,,"Asa [Aspirin], Biaxin [Clarithromycin], Nucala [Mepolizumab], Xolair [Omalizumab]","['Asthma', 'Bilevel positive airway pressure', 'Blood potassium decreased', 'Condition aggravated', 'Endotracheal intubation', 'Respiratory failure', 'Wheezing', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 955475,NY,72.0,F,Blood blisters around the mouth (inside cheeks and tongue). Tiny bruises in the arms and legs Worsening of previous skin rashes,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,01/19/2021,1.0,OTH,Xanpurin 300mg (anti-gout) and Xelevia 100mg (Anti-diabetic).,,,,None,"['Blood blister', 'Contusion', 'Rash']",1,MODERNA,SYR 955478,NC,81.0,F,Systemic: Anaphylaxis-Severe; symptoms lasted 1 day,Not Reported,,Yes,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,SEN,,,,,No known allergies,['Anaphylactic reaction'],1,MODERNA,IM 955491,NC,48.0,F,"Systemic: Anaphylaxis-Severe, Systemic: Seizure-Severe",Not Reported,,Yes,Not Reported,,Not Reported,U,01/15/2021,01/15/2021,0.0,SEN,,,,,unknown,"['Anaphylactic reaction', 'Seizure']",1,MODERNA,SC 955516,WI,64.0,F,"Temp of 104.5, hospitalization",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/29/2020,12/30/2020,1.0,SEN,"""allopurinol tablet; 200 mg; oral Once A Day; AM"" ""calcium carbonate tablet,chewable; 1000 mg; oral Once An Evening; PM"" ""ferrous fumarate tablet; 325 mg (106 mg iron); oral S",Cellulitis,"ESRD, kidney transplant, pulmonary fibrosis, asthma, A. fib",,"amoxicillin-pot clavulanate, ciprofloxacin HCl, doxycycline hyclate, Levaquin, levofloxacin",['Body temperature increased'],UNK,MODERNA,IM 955532,NJ,51.0,F,"COVID 19 Vaccination administered by pharmacy staff. No adverse effect at the present time. Staff will continue to observe adverse reaction. Will continue to monitor. Patient at start of shift awake in the bed. Pt at 3am was on the commode leaned to the side. Patient body still warm to touch no pulse. Called for assistance Asap. Cpr started promptly. Cpr given patient on floor 911 arrived at the scene at 3:10am Cpr rotated Between Nursing and EMT on Scene. Cpr was given to patient for over 45 minutes. Patient was pronounced at the scene at 3:50am. Call placed to Pt family by supervisor on shift. MD to be notified. AT 3:00am, I was notified by the nurse that resident is unresponsive. Upon entering room, resident was sitting on the commode unresponsive with absent respiration and pulse. Resident lowered down on the floor with 4 person assist. CPR initiated, AED pads placed on chest with no shock indicated. 911 called and EMT and paramedics arrived around 3:10am. ACLS performed until code stopped and pronounced death at 3:48am. I called and notified family member of his demise and awaiting for family to call us back for funeral arrangements.",Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,,,SEN,Lantus SoloStar; Atorvastatin Calcium; Gabapentin; Potassium Chloride ER; Levothyroxine Sodium; Alogliptin Benzoate; Acetaminophen; Milk of Magnesia; Enema Rectal; Bisacodyl Rectal Suppository; Tramadol HCl; Ceftriaxone Sodium; Santyl Exter,"Cellulitis of RLE, S/P wound debridement","HTN, Morbid obese, Diabetes, Hypothyroidism, HTN",,NKA,"['Cardioversion', 'Death', 'Posture abnormal', 'Pulse absent', 'Respiratory arrest', 'Resuscitation', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 955565,OH,19.0,F,"One week after the shot (1-14-2021) Patient (19 y.o.)reported side pain and appeared constipated, Laxatives given along with Tylenol, on further assessment Patient was noted to have left leg redness and abdominal fullness. Dr. was updated and we had orders for close monitoring, the next day when she got up, her leg appeared better, and she had passed a small BM, but by lunch she had developed significant pain and edema in her left leg, and the color of her leg was reddened again. She was sent to the emergency room with her symptoms. She was admitted back to our facility yesterday, her diagnoses included Acute provoked left external illiac, femoral, popliteal, and peroneal DVT. Elevated Factor II levels, Elevated APC resistant, May-Thurner Syndrome, history of developmental disabilities, fecal impaction and urinary retention - suspected related to her fecal impaction. Vascular surgery was consulted, and pt. was started on a heparin drip, and mechanical thrombectomy was needed for both legs due to multiple clots. She was started on Eliquis and Plavix, and thigh high compression stockings were ordered, ace wraps being used until these are supplied. Her Fecal impaction was addressed also and the urinary retention resolved.",Not Reported,,Yes,Yes,3.0,Not Reported,N,01/07/2021,01/14/2021,7.0,OTH,"Benztropine Mesylate 1 mg. by mouth twice daily clozapine 50 mg. by mouth daily at 0700 and 1600, 100 mg. daily by mouth at 8 p.m. (200 mg. total daily) Junel 1-20, one tablet by mouth once daily Ativan 0.5 mg. by mouth three times daily","Patient was actively being treated for Bipolar disorder with most recent episode depression, Anxiety disorder, ADHD, Oppositional Defiant disorder, Autism Spectrum Disorder, Fetal Alcohol Syndrome, Intermittent Explosive Disorder, a history of Pseudo-seizures, and insomnia. She has Alopecia Areata, and allergic rhinitis, and constipation. She has a history of left eye strabismus and uses glasses. She has not been acutely ill prior to vaccination.","See above, history also of right radial neck fracture in 2019 with ORIF repair. Living at Center for behavioral management and stabilization",,Ideopathic reaction to clonidine and benadryl - Awake for days after use Risperdal causes Aggression No true allergies,"['Abdominal distension', 'Activated protein C resistance test positive', 'Coagulation test', 'Computerised tomogram abdomen', 'Constipation', 'Deep vein thrombosis', 'Electrocardiogram', 'Erythema', 'Faecaloma', 'Flank pain', 'Laboratory test', 'May-Thurner syndrome', 'Oedema peripheral', 'Pain in extremity', 'Prothrombin level increased', 'Thrombectomy', 'Urinary retention', 'Vascular test', 'Venogram', 'Venous stent insertion']",1,MODERNA,IM 955597,NE,50.0,M,Death,Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/15/2021,2.0,PUB,Levothyroxine Calcium Acetate Albuterol Clonidine Hydralazine Ropinirole Aspirin Ergocalciferol Metoprolol Ondansetron Rifaximin Hydroxyzine Mutlivitamins Buspirone Pantoprazole Oxycodone Atorvastatin,,Major Depressive Disorder Hepatitis C Essential Hypertension Diabetes Type 2 Alcoholic Cirrhosis Hypothyroidism Chronic Kidney Disease Stage 5 Asthma,,Contrast media,['Death'],1,PFIZER\BIONTECH,IM 955656,NH,30.0,F,Woke Up on Thursday and arm was swollen about half dollar sign amount at the injection site.. Tissue underneath the skin was harder Area was raised about a quarter of an inch Red and itchy Vomited Estimated date if delivery - 07/31/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/07/2021,7.0,PVT,Prenatal Vitamins,Nope,None Mild Asthma,,Peanuts Tree Nuts,"['Exposure during pregnancy', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Vomiting']",1,MODERNA,IM 955754,TN,,F,"neuropathy; Information has been received from a lawyer, regarding a case in litigation and refers to a female patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. In or around February 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered neuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of neuropathy to be related to zoster vaccine live (ZOSTAVAX). The event of neuropathy was considered to be disabling. Upon internal review, the event of neuropathy was determined to be medically significant.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/01/2016,,,UNK,,Routine health maintenance,,,,['Neuropathy peripheral'],UNK,MERCK & CO. INC.,OT 955758,,,F,"right sided weakness with numbness from her face down her entire body; right sided weakness with numbness from her face down her entire body; right sided weakness with numbness from her face down her entire body; bad headache; pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 41 unknown unit) received the first dose of bnt162b2 (BNT162B2) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know how long side effects last after receiving the first dose of the Covid vaccine. The patient received first dose of Covid vaccine on Thursday (unspecified date) and reported side effects. She reported side effects of right sided weakness with numbness from her face down her entire body. She describes the feeling as if she's been ""shot up with novocaine on the right side of her body."" She was also experiencing a really bad headache and pain at the injection site. She reported that the side effects do not seem to be wearing off. She wanted to know if this has been reported as a common side effect. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Headache', 'Hemiparesis', 'Hypoaesthesia', 'Injection site pain']",1,PFIZER\BIONTECH, 955759,,27.0,F,"Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe malaise; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; loss of appetite; Transient dysgeusia; Mild nausea; Pleuritic chest pain; This is a spontaneous report from a non-contactable physician. This 27-year-old female physician (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=E15249), via unspecified route at left arm on 08Jan2021 07:30 AM at single dose for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization. Facility type of vaccine was hospital. No other vaccine in four weeks. No Covid prior vaccination. No covid tested post vaccination. On 08Jan2021 06:00 PM, patient experienced severe headache from 12-36h post administration (as reported), impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia (nearly meningeal signs); mild nausea; pleuritic chest pain; severe malaise; transient dysgeusia; loss of appetite. Treatment for events included initially NSAIDs until had difficulty tolerating was received. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Decreased appetite', 'Dysgeusia', 'Headache', 'Loss of personal independence in daily activities', 'Malaise', 'Nausea', 'Pain', 'Photophobia', 'Pleuritic pain']",2,PFIZER\BIONTECH, 955760,,25.0,F,"tachycardia; shortness of breath; elevated blood pressure 165/90; tired; stomach upset; felt unwell; This is a spontaneous report from a contactable other health professional (patient). A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced on 04Jan2021 felt unwell, tired, stomach upset (it continued all week) and on 07Jan2021 tachycardia and shortness of breath. Clinical course: she was feeling very like short of breath and her heart racing, had elevated blood pressure 165/90, usually it was normal. The patient was sent to the emergency room (ER) and got worked up, she had a complete blood panel, everything came back normal; she had a chest X-Ray and 2 bags of fluid, then the patient was discharged. The patient outcome of the events was recovered. The information on the batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/04/2021,4.0,UNK,,,,,,"['Abdominal discomfort', 'Blood pressure increased', 'Chest X-ray', 'Dyspnoea', 'Fatigue', 'Full blood count normal', 'Malaise', 'Palpitations', 'Tachycardia']",1,PFIZER\BIONTECH, 955761,PA,35.0,F,"started having a lot of left eye pain/he diagnosed her with Scleritis; This is a spontaneous report from a contactable other healthcare professional (HCP) a Nurse Practitioner, who reported for herself. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EJ1685 also reported as ES1685), intramuscular in left deltoid on 24Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing anxiety diagnosed years ago, maybe when she was 23. Concomitant medication included ongoing celecoxib (CELEXA) for anxiety started about a year, or year and a half ago. She did not take other vaccines on the same day as the COVID vaccine. She had no recent labs. On 02Jan2021 the patient experienced scleritis. Event was described as follows: patient got her first COVID vaccine on 24Dec2020 and on 02Jan2021 she started having a lot of left eye pain. She went to her Ophthalmologist and he diagnosed her with Scleritis. She had no history of anything with her eyes or any vascular or autoimmune issues; no eye disorder history or rheumatology history. Patient is due to get her second dose of the vaccine on 14Jan2021, and she spoke with her primary care doctor and her ophthalmologist, and neither of them have any answer on if she should get the second dose or not, they did not have much guidance for her as this was such a new product. Patient reported that scleritis was persisting, but it has improved and she was on Prednisone eye drops. Event scleritis was considered serious as Medically significant because of what it is and what it can do, but this was not a severe case (as reported). Final outcome of scleritis was recovering.; Sender's Comments: The reported scleritis was more likely an intercurrent disease, and less likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/02/2021,9.0,UNK,CELEXA [CELECOXIB],"Anxiety (diagnosed years ago, maybe when she was 23)",,,,"['Eye pain', 'Scleritis']",1,PFIZER\BIONTECH,OT 955762,MI,65.0,F,"Appendicitis; Vomiting; Nausea; Chills; This is a spontaneous report from a contactable consumer. A consumer reported that her 65-year-old mother received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number Unknown), into the arm at single dose on 31Dec2020 for COVID-19 immunization. The patient did not have any medical history and did not receive any concomitant products. On 31Dec2020 the same evening of vaccination, the patient experienced vomiting, nausea and chills that were considered flu like. On 03Jan2021 or 04Jan2021 her appendix ruptured. She entered emergency room on 07Jan2021 and was diagnosed with appendicitis. She was admitted to hospital on 07Jan2021. She has been given hospital care for past four days. She will have surgery in 6 weeks to repair and right now they are cleaning ruptured area. Her care team is wondering if she should get second dosage. The patient is currently hospitalized. The patient recovered from the event vomiting on 31Dec2020, recovered from the events Nausea and Chills on 07Jan2021 and was Recovering from the appendicitis. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Appendicitis', 'Appendicitis perforated', 'Chills', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH, 955869,NC,63.0,F,"Bell's Palsy; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: ELD14D, via an unspecified route of administration, in left side of arm, on 04Jan2021 at single dose for COVID-19 immunization. Medical history included early breast cancer from 2017 and ongoing. Concomitant medication included tamoxifen citrate 20 mg tablet by mouth once daily from 2017 and ongoing for breast cancer (cancer pill, she has to be on it for 5 years). The patient received the vaccine as she is ""with fire department, thought she needed to take it, she had early breast cancer, is around lots of people"". On 09Jan2021 the patient was diagnosed with Bell's palsy, assessed as medically significant and in Jan2021 she experienced earache (she thought it was an earache, but it was more than that, but it made her ear hurt, and she has no infection), her mouth was drawled a little, further detailed as numbness and ""the eye, it is messing with it, when she is trying to see out of it, she can see, but it's blurry like"" and, ""where the ear thing is"", on the back of the lymph node was real sore and her face was kind of puffy, which is the reason she went to the doctor. The patient had to go to her doctor, he told her she had a reaction to the shot, he called it Bell's Palsy, and said to let Pfizer know. Her doctor gave her something to take for mouth drawled/numbness, which is supposed to help, and she has to go back in a week. The event Bell's palsy outcome was unknown at the time of the report.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/09/2021,5.0,UNK,,Breast cancer (Early breast cancer),,,,"['Ear pain', 'Facial paralysis', 'Hypoaesthesia oral', 'Lymph node pain', 'Swelling face', 'Vision blurred']",1,PFIZER\BIONTECH, 955871,WI,61.0,F,"Doesn't feel like eating; Fever; Chills/ Chilled; Nausea; Severe Headache/Dull headache/Frontal headache; Fatigue; Body aches; This is a spontaneous report from a contactable Nurse (patient). This 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1686), via intramuscular, on 06Jan2021 (at 14:30) at single dose at left deltoid for COVID-19 immunisation, administered at hospital. Age at vaccination is 61-year-old. Historical vaccine included Diphtheria and Tetanus vaccine (intramuscular, at single dose) on 15Dec2020 for immunization; and Shingles vaccine (intramuscular, at single dose) on 15Dec2020 for varicella immunization. Relevant medical history included usual tenderness. No relevant concomitant medications were provided. On 07Jan2021, she woke up at 2:00 in the morning, she had a high temperature, she was chilled, she had a severe headache, nausea, fatigue, and body aches. She got up and took ibuprofen (ADVIL). She was basically in bed, she had to cancel all her appointments in the morning, she just laid in bed and the following afternoon her fever broke at about 4:30 in the afternoon then she just had a low grade temperature and a dull headache, nausea through the next day, Friday the 08Jan2021. She still has a very dull headache and just not right, kind of like a flu bug. She had no fever; she had not had any fever after Friday afternoon or Saturday. Fever started at 2 in the morning 07Jan2021 and she experienced the chills until after fever broke. Fever went above 102 degrees. She still had a little of the nausea, she just didn't feel like eating. She still had the dull headache. The nausea and headache have improved when compared to how it was on the 07Jan2021. She was back to work now she just has a dull frontal headache. The reporting nurse assessed all the events, except of 'Doesn't feel like eating', serious for disability. She stated she may have had usual tenderness but nothing like this. The patient had recovered from the event fever on 08Jan2021 and from the event 'chills/chilled' on 07Jan2021; the patient was recovering from 'nausea' and 'severe Headache/Dull headache/Frontal headache', while the outcome of the remaining events was unknown.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded due to temporal relationship. It is worth noting that patient had other vaccines not far ago, including Diphtheria and Tetanus vaccine and Shingles vaccine on 15Dec2020 for immunization. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/06/2021,01/07/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Tenderness (usual),,,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Influenza like illness', 'Loss of personal independence in daily activities', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,OT 955872,,,U,"throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow. The patient condition was life threatening. The patient described the events as follows: 40 min after injection my throat and tongue started to feel weird and tight. Pharmacy at my work hospital gave me 25 mg Benadryl and 650mg Tylenol. At about 1 hr 45 min after injection my throat got to the point of so swollen and itchy I couldn't swallow. I went to nearest emergency room hospital they administered Decadron orally, Pepcid P.O. (orally), and Toradol via IM (Intramuscular). The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Dysphagia', 'Oropharyngeal discomfort', 'Pharyngeal swelling', 'Throat irritation', 'Throat tightness', 'Tongue discomfort']",UNK,PFIZER\BIONTECH, 955874,FL,62.0,M,"Have a cut in my leg which is very unusual; Saw a big cut in my feet; I was bleeding from somewhere; It was quite a lot of blood drawing out of my body; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient started to receive single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 23Dec2020 09:00 for COVID-19 immunization; and adalimumab (HUMIRA), via an unspecified route of administration from an unspecified date at unspecified dose (injection every other month) for arthritis. Medical history included arthritis, blood pressure (abnormal), and blood cholesterol (abnormal). Concomitant medication included rosuvastatin for blood cholesterol, olmesartan medoxomil, metoprolol succinate (TOPROL XL), and vitamins: ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride. Patient stated, ""The reason I am calling, I have just a concern that something happened to me. I did not pay much attention but now I have read the news one doctor died after getting this COVID Vaccine (Further details were not available over the call) I have a small incident happened to me the day after I received my first dose of the COVID Vaccine. I just wanted to get some information. You know what happened the next day night, in the evening I was taking a shower and all of sudden I was bleeding from somewhere. Lot of blood was coming out while I was toweling my body out. I couldn't find out where the blood is coming from. I checked, it's not from my urine, not from my rectum but it was quite a lot of blood drawing out of my body. Immediately, I called my wife into bathroom, then I squeezed my body then the bleeding stops. It was on 24Dec2020. You know my kids were at home. I don't want them to find it. The bleeding stopped and everything went away. Then I thought maybe it is something related to my GI. I went to my GI doctor yesterday to have a checkup, they don't know anything either but I am due for my second dose for next week Wednesday. Now I had this news about thrombocytopenia on this doctor died (Clarification unknown). So I am just afraid if there is anything related this. Do you have any explanation on how I bleed and where it bleed? It was lot of bleeding even my towel was full of blood."" Patient wanted to see if anybody else had similar experience or if he get the second dose and he get the complication again. Patient was a medical technologist. He was doing ultrasounds. He was working in a pediatric hospital. Patient was not prescribed/recommended vaccination. ""Nobody recommended it. During my hospital. I am healthcare professional. So everybody in my hospital. I just went there and get it. I didn't ask my doctor."" Patient added, ""You know everything I read about this case and then you know, I have a cut in my leg which is very unusual. I have never seen that. I don't know how it happened. You know all of sudden oneday I wake up and I saw a big cut in my feet also. So, I am just afraid (onset date not reported)."" The action taken in response to the events for adalimumab was unknown. The outcome of the events was unknown. Information about Lot/Batch number is requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/24/2020,1.0,PVT,; ; TOPROL XL; VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] HUMIRA,,Medical History/Concurrent Conditions: Arthritis; Blood cholesterol abnormal; Blood pressure abnormal,,,"['Haemorrhage', 'Skin laceration']",UNK,PFIZER\BIONTECH, 955876,PA,52.0,F,"Possible Bells Palsy; Arm/neck soreness; Arm/neck soreness/ neck are painful; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; Feel numb; Sore-all on same side as injection; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of bnt162b2 (Pfizer COVID 19 vaccine, lot number: EL3246) , via an unspecified route of administration on 13Jan2021 17:00 at single dose on left arm for covid-19 immunisation . The patient medical history was not reported. Concomitant medication included fluticasone propionate (FLONASE), pantoprazole. The patient experienced arm/neck soreness, travel up neck to side of face/around temple; side of head/face/cheeks/jaw, neck are painful, feel numb, and sore-all on same side as injection; and possible Bells Palsy on 14Jan2021 02:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. No treatment was received for the events. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,PVT,FLONASE [FLUTICASONE PROPIONATE];,,,,,"['Facial pain', 'Headache', 'Hypoaesthesia', 'Neck pain', 'Pain in extremity', 'Pain in jaw']",1,PFIZER\BIONTECH, 955879,OH,,U,"expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar death events for 8 patients. This report is for 5th of 8 patients. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. The patient died on an unspecified date. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case. The event death with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available.,Linked Report(s) : US-PFIZER INC-2021034595 same drug, reporter and event but different patient; Reported Cause(s) of Death: expired before receiving the second dose",Yes,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,,,UNK,,,,,,['Death'],1,PFIZER\BIONTECH, 955880,OH,,U,"passed unexpectedly; This is a spontaneous report from a contactable nurse communicated to a Pfizer colleague. This nurse reported similar death events for 8 patients. This report is for 8th of 8 patients. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient passed unexpectedly on an unspecified date. The patient died on an unspecified date. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case. The event death with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034595 same drug, reporter and event but different patient; Reported Cause(s) of Death: passed unexpectedly",Yes,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,,,OTH,,,,,,['Death'],UNK,PFIZER\BIONTECH, 955882,ID,25.0,F,"allergy; Short of breath; Tachycardia/my heartrate was like 140 - 150; Blood pressure was like 165 over 114/my blood pressure just like skyrocketed; Upset stomach; Tired; Started to feel not very good/not feeling like wonderful/overall sickness; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL014 (can't really tell), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. Medical history included allergy and heartburn. Concomitant medication included omeprazole for heartburn, cetirizine hydrochloride (off-brand for Zyrtec) as allergy medicine and a birth control medicine. Consumer stated, she just was calling this number because she didn't necessarily know if she had an adverse reaction or a symptom. She just wanted to report it and see if maybe you had any insight if this has happened to anybody else. Consumer further stated, she had an adverse reaction where she had to go to the emergency room. So, she didn't know if it was from the Vaccine or not because her reaction was very delayed. She got her vaccine on 31Dec2020, New Year's Eve and then starting on Monday after the vaccine on 04Jan2021. She started to feel not very good, it was mostly just like overall sickness, just as muscle aches, tired, having upset stomach so that was after 4 days. Patient had allergy from an unspecified date. And then on 07Jan2021, a week after she got the vaccine, she had signs of tachycardia and her blood pressure just like skyrocketed, her blood pressure was like 165 over a 114 and her heartrate was like 140 - 150. And she worked in healthcare, which was why she was one of the first ones to get the vaccine and she went to the ER and got worked up and they couldn't find, nothing was abnormal with her labs or blood work. She even had a chest X-ray and they couldn't find anything and they just gave her fluids and sent her home. And she was home now and still not feeling like wonderful, she felt better though but she just wanted to report that and see if there was any correlation. She didn't really know because it was so delayed, a week later. So she just wanted to report it. Consumer further stated, she forget to tell one thing, she was also short of breath on 07Jan2021. So that was why they had sent her to ER because of Tachycardia, shortness of breath and her blood pressure was really high. They didn't give her any medicine they just gave two big bags of fluid and then they discharged her. Consumer stated, she was scheduled to have her second one, she thought it was 14Jan2021. She wanted to know if she should get the second one. Consumer stated, when she went into the ER she had a lot of lab work. She didn't even know what all they did but a lot like, blood panels, she checked everything was there, that was on Thursday, last week, 07Jan2021. Consumer stated no treatment was received for the events. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/04/2021,4.0,UNK,; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Allergy (Verbatim: Allergy); Heartburn,,,"['Abdominal discomfort', 'Blood pressure increased', 'Blood test normal', 'Chest X-ray normal', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Illness', 'Myalgia', 'Tachycardia']",UNK,PFIZER\BIONTECH, 955911,NC,40.0,F,"Approximately 3 days after my injection I began experience severe tremors Ib bilateral arms, bilateral legs, head, and vocal cord tremors as well as blurry vision and memory impairment. Unfortunately, the symptoms don't seem to be improving. My MD prescribed metoprolol, which I will begin today.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/15/2021,01/17/2021,2.0,PUB,,,"Asthma, Hashimoto's Thyroidits",,,"['Head titubation', 'Laryngeal tremor', 'Memory impairment', 'Tremor', 'Vision blurred']",1,MODERNA,IM 955945,MA,53.0,F,"a couple hours after the vaccine, I experienced a bit of rapid heart rate, which resolved after a few minutes. The following day around 3 pm I began to have chills and felt like I had the raid heart rate again. By 5 pm I was beginning to feel really bad, I was freezing, chills and my heart rate was now extremely fast, I was having trouble speaking complete sentences, my husband drove me to the emergency department. I had a very high heart rate and high fever, I was admitted and in the hospital until Sunday afternoon. The diagnosis was pneumonia, I don't really believe this, as I felt fine and had no symptoms prior to the onset of the fever.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,01/14/2021,01/15/2021,1.0,PUB,No medications,None,"obesity, afib, covid 19 in March 2020",,No known allergies,"['Atrial fibrillation', 'Chest X-ray abnormal', 'Chills', 'Condition aggravated', 'Electrocardiogram abnormal', 'Feeling abnormal', 'Feeling cold', 'Heart rate increased', 'Influenza virus test negative', 'Laboratory test', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test negative', 'Speech disorder']",1,MODERNA,IM 955959,NM,82.0,M,Patient died 1 week after vaccination. According to family was having very rapid decline in status in recent weeks and they did not think related to vaccination.,Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/18/2021,7.0,OTH,"alfuzosin, allopurinol. amlodipine, aspirin, Sinemet, vitamin D, multivitamin, Lexapro, finasteride, mirtazipine, ropinirole, trospium",recently diagnosed with progressive supranuclear palsy,"BPH, HTN, gout, GERD, hyperlipidemia",,none,['Death'],UNK,MODERNA,IM 955966,OH,31.0,F,"Anaphylaxis less than two hours after vaccination. I had no symptoms immediately after vaccine however did develop symptoms within one minute of completing a run. Developed b/l hand swelling and tingling, diffuse hives and itching, tachycardia, elevated blood pressure, lips tingling and swelling which required emergency room visit and EpiPen, IV fluids, Benadryl and IV steroids. This is similar to previous reactions I have had to running previously. Symptoms resolved within one hour after treatment in ED.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,MIL,"Tri-sprintec (oral birth control), Epi-pen (prn anaphylaxis)",None,Exercise induced Anaphylaxis Iron deficiency Anemia PTSD,,Anaphylaxis to exercise,"['Anaphylactic reaction', 'Blood pressure increased', 'Laboratory test', 'Lip swelling', 'Paraesthesia', 'Paraesthesia oral', 'Peripheral swelling', 'Pruritus', 'Tachycardia', 'Urticaria']",1,PFIZER\BIONTECH,IM 955968,TX,61.0,F,"Severe headaches, vomiting, dehydration, shortness of breath ... led to trip to Emergency Room at Hospital on 1/16/21 at 10:45 am; diagnosis for treatment was Diabetic Ketoacidosis (DKA); patient was admitted to ICU to address critical fluid and electrolyte imbalances , headaches, body aches, dehydration, nausea, shortness of breath. DKA is medical emergency.",Not Reported,,Yes,Yes,4.0,Not Reported,N,01/14/2021,01/15/2021,1.0,OTH,Probiotic Culturelle; Centrum Silver vitamins; Vitamin D3 x 2; Farxiga 10; Melatonin 5mg as needed; aspirin 81mg; Atorvastatin 20 mg; Omerprazole 40mg; Tresiba 7 units daily; Ozempic 50 units weekly; Fiasp 5 units as needed with meals,None,Diabetes 1.5,,None,"['Carbon dioxide decreased', 'Condition aggravated', 'Dehydration', 'Diabetic ketoacidosis', 'Dyspnoea', 'Electrolyte imbalance', 'Headache', 'Intensive care', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,SYR 955979,LA,57.0,M,Pt brought to the ER with SVT. He was given 2 doses of adenosine by EMT's. Pt was found to have hypomagnesemia and hypophosphatemia in the ER. He was admitted for observation and evaluated by Cardiology. He remained stable with NSR during admission. Pt has a follow up appt with Cardiology EP clinic on 2/18/21.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/12/2021,01/13/2021,1.0,PVT,"amlodipine, metformin, glipizide, cetirizine, lisinopril/HCTZ, meloxicam",none,"Type 2 Diabetes Mellitus Hypertension DISH, Osteoarthritis",,Penicillin,"['Blood creatine increased', 'Blood magnesium decreased', 'Blood phosphorus decreased', 'Glycosylated haemoglobin increased', 'Hypomagnesaemia', 'Hypophosphataemia', 'Supraventricular tachycardia']",UNK,MODERNA,IM 956011,IL,34.0,F,"Woke up feeling achy, chills, Feverish Low grade fever Estimated date of delivery 08/25/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,IVF Progesterone,Na,na,Flue Vaccine - Pain a the injection site,Dye,"['Chills', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 956023,,51.0,F,"Fatigue, wheezing, soreness, palpitations",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Patient took ibuprofen after vaccine and also albuterol inhaler,,Asthmatic patient,,No known allergies,"['Fatigue', 'Pain', 'Palpitations', 'SARS-CoV-2 test negative', 'Wheezing']",UNK,PFIZER\BIONTECH, 956075,CA,38.0,F,"38 year old female - healthy with no significant past medical history. Morning of 1/15/21, pt woke up with difficulty speaking (would be talking and then unable to articulate words which were replaced by grunting sounds) and tingling to her face. No changes to breathing, no numbness/tingling to extremities, equal facial symmetry. Slow onset of symptoms. Pt went to the ED, where she received a CT, MRI (inconclusive reading), lab work reported as normal per pt, EKG and chest x-ray. Symptoms self resolved while in the ED, however MD staff wanted to admit patient for 24 hours of observation and to complete an echocardiogram. Pt left AMA the evening of 1/15/21 due to resolution of symptoms and wanting to follow up with her cardiologist for the echocardiogram. Pt told by MD staff symptoms were likely caused by either TIA, possible reaction to vaccine or migraine presentation (no report of headaches/auras). Plan was to have patient on blood thinners x 30 days then baby Aspirin thereafter. Pt still needing to follow up with PCP and cardiologist for further work up.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/12/2021,01/15/2021,3.0,PVT,,,,,NKA,"['Chest X-ray', 'Computerised tomogram', 'Electrocardiogram', 'Grunting', 'Laboratory test normal', 'Magnetic resonance imaging', 'Paraesthesia', 'Speech disorder', 'Transient ischaemic attack']",1,MODERNA, 956165,FL,80.0,M,"Received vaccine on 1/16/21, on 1/17/21 started with coughing, white phlegm, SOB and on 1/18/21 developed fever to 101 and increased need for oxygen. Home requirement increased from 3L O2 to 6L O2. On 1/18/21 presented to hospital. Quickly defervesced with steroids and cefepime. Possible post-obstructive pneumonia vs immune response to vaccination.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/16/2021,01/18/2021,2.0,PVT,Methylfolate Zinc Vitamin C Vitamin D3 ipratropium/albuterol oxygen ipratropium nasal spray doxazosin dutasteride monelukast synthroid centrum silver trelegy omeprazole rimaintadine proair rosuvastatin tramadol vitamin b12,,Non-small cell lung cancer s/p resections and radiation asthma COPD BPH Vitiligo,,demerol,"['Cough', 'Dyspnoea', 'Oxygen therapy', 'Productive cough', 'Pyrexia']",UNK,PFIZER\BIONTECH, 956178,PR,43.0,M,"Patient could not open and close hand after the first day of vaccination. On the third day his arm turned purple and could not be moved and was numb. A week and a half after vaccine, arm hurt and was numb. Patient was hospitalized.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/08/2021,01/10/2021,2.0,PVT,None,None,T2DM,,None,"['Hypoaesthesia', 'Mobility decreased', 'Muscle enzyme increased', 'Pain in extremity', 'Skin discolouration']",1,PFIZER\BIONTECH,IM 956211,KY,91.0,M,patient passed away on 1/12 at 1800 from a ruptured colonic mass.,Yes,01/12/2021,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,PVT,"amiodarone (PACERONE) 100 mg Tablet ferrous gluconate (FERGON) 324 mg (38 mg iron) Tablet furosemide (LASIX) 20 mg tablet lidocaine (XYLOCAINE) 2 % Solution Melatonin 1 mg Tablet nystatin (MYCOSTATIN) 100,000 unit/mL suspension","known colonic mass, presumed malignant but no biopsy diagnosis.",Hypertension hyperlipidemia Factor VIII inhibitor disorder SVT and symptomatic ectopy,,NKDA,"['Computerised tomogram abdomen', 'Death', 'Large intestine perforation', 'SARS-CoV-2 test negative']",UNK,UNKNOWN MANUFACTURER, 956225,CA,82.0,M,"Systemic: Pt monitored by nursing for 30min after inj,pt was stable/no reaction.At ~1hr post inj pt was unresponsive.Pt was a hospice/dnr per director",Yes,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/16/2021,0.0,SEN,,,,,No known allergies,['Unresponsive to stimuli'],1,PFIZER\BIONTECH,IM 956260,ID,29.0,F,"Pregnancy history: 27 weeks at time of injection, history of a significant subchorionic hematoma at 12.5 weeks, vaginal bleeding at that time. Two more episodes of light spotting (dark in color) over the next week and a half. Then no more vaginal bleeding. Growth ultrasound showed no concerns other than healing SCH, nothing indicated for follow up or concern. Date of delivery: 4/7/21. No birth weight yet, still pregnant. Baby was measuring at 25th percentile for weight at 20 week ultrasound. Adverse events: strong, shooting pains felt in area of cervix extending upward. Irregular (every hour or half hour) increasing in frequency (around 6:00 I had four within ten minutes). Throughout the day after getting my vaccine I purposefully stated physically low key. No exercise or long walking etc. At 6:00 when the pains came more frequently I stopped reading to my daughter and laid down, drank more water, electrolytes, took a topical progesterone 90mg vaginally, two more acetaminophen (had taken 2 of these 20 minutes after injection) and napped. Next morning uterus/cervix felt tender with some cramping especially when lifting and holding leg up (to put pant leg on). Did not go to work, laid down most of the day. By end of day feeling less tender.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PUB,"prenatal vitamin, daily. vitamin D supplement, daily.",no. Possibly a light cold mid december?,"virus-induced asthma, only present during virus illnesses.",,none known,"['Exposure during pregnancy', 'Uterine cervical pain', 'Uterine tenderness']",1,PFIZER\BIONTECH,IM 956263,TX,30.0,F,"I received the vaccination on 1/14 and started to get an itching sensation that night - nothing noticeably or concern and was able to go to sleep. The next morning I was very itchy and red and started to break out in hives that started to get worse and spread through my body. I took Benadryl throughout the day and at night to help my sleep. On Saturday morning my eyes were swollen and red, I had severe hives all over my body and had to go to the ER for some type of relief. This was immediately after I woke up, the right side of my body was extremely hot and I went to the restroom and looked in the mirror and didn't recognize myself. At the ER, they put me on Prednisone - to take 2 tablets for 3 days, Famotidine - taking 1 tab, 2 times a day for 5 days, and Benadryl, 1 tab, 3X a day until the symptoms subside - It is currently 1/19 and my skin will start to heat up, primarily in my hands and start to itch, but no more hives or anything severe. I am currently pregnant with my first child, due date 7/7/2021. I have had no previous pregnancies, miscarriages, or abortions.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/14/2021,0.0,PVT,Pre-Natal - Nature Made vitamin,,,,,"['Erythema', 'Exposure during pregnancy', 'Eye swelling', 'Feeling hot', 'Ocular hyperaemia', 'Pruritus', 'Urticaria']",1,MODERNA,IM 956311,WI,50.0,M,Received fist Moderna Vaccine 12/30/2020. 01/07/2021 Started with bil leg numbness and weakness. By 1/15/2021 numbness constant both legs. Electric shock sensation at times down spine to feet. Weakness both legs started 1/18/2021. Neurologic injury being worked up for transverse myelith.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,PVT,Unknown,,,,,"['Hypoaesthesia', 'Magnetic resonance imaging spinal normal', 'Muscular weakness', 'Nerve injury', 'Paraesthesia']",1,MODERNA,IM 956345,CO,51.0,F,"9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/05/2021,01/05/2021,0.0,PVT,,,,,"Phenergan, Reglan, Morphine","['Axillary pain', 'Chills', 'Computerised tomogram', 'Electrocardiogram', 'Facial paralysis', 'Fatigue', 'Feeling abnormal', 'Laboratory test', 'Lymphadenopathy', 'Magnetic resonance imaging', 'Malaise', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vocal cord disorder']",2,PFIZER\BIONTECH,IM 956348,VT,81.0,M,Systemic: Anaphylaxis-Severe,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/17/2021,01/17/2021,0.0,SEN,,,,,,['Anaphylactic reaction'],1,PFIZER\BIONTECH,IM 956365,CA,81.0,F,"12/28/2020: generalized weakness and fell twice at home, cough, nausea,1/04/2021: cough, nausea, fever and chronic pain when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on bipap, 1/15/2021: pt was intubated, on TPN, pt DNR, 1/18/2021: was extubated and put on comfort measures and passed away",Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,,12/21/2020,01/04/2021,14.0,PVT,,,,,,"['Asthenia', 'Bilevel positive airway pressure', 'COVID-19 pneumonia', 'Cough', 'Death', 'Dyspnoea', 'Endotracheal intubation', 'Fall', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 956438,OH,14.0,F,Flu vaccine. 10/31/20 - known Mast Cell Activation Syndrome Hives started later that evening. Over the course of the next week some difficulty breathing felt to be an issue with her vocal cords and/or throat. Admitted to hosp 11/6/20,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,10/31/2020,,,PVT,Sertraline,None,Mast cell activation syndrome Anxiety,,NKDA,"['Chest X-ray normal', 'Dyspnoea', 'Electrocardiogram normal', 'Mast cell activation syndrome', 'Oropharyngeal discomfort', 'Urticaria', 'Vocal cord disorder']",UNK,GLAXOSMITHKLINE BIOLOGICALS, 956458,MA,60.0,M,"Patient was vaccinated for SARS-CoV-2 on 6-Jan-21 at his site of employment, a Nursing Home. Patient presented to Urgent Care on 15-Jan-21 complaining of left sided chest pain that started the evening before with an associated slight cough. Pt was afebrile with a heart rate of 88 and an O2 sat on room air of 98% in triage. His EKG showed a sinus tachycardia of 114 with a slightly prolonged QTc of 463 ms. Physical exam was significant for bibasilar crackles and X-ray showed bibasilar infiltrates consistent with COVID pneumonia but bacterial pneumonia could not be excluded. The patients BP was documented as 97/64. He was treated with Zofran for nausea and tylenol. He was prescribed a five day course of Azithromycin, an Albuterol inhaler, guaifenessin with codeine cough syrup, and Zofran. Labs were drawn and he was discharged. His lab results were reported after his departure and were significant for a white blood cell count of 1.33, platelet count of 73, 2% myelocytes, 1% metamyelocytes, an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline phosphatase of 294 and AST of 112 with ALT noted to be within normal limit. His COVID nasopharyngeal swab from the visit was reported as negative and a swab performed at his employment on 13-Jan-21 was also reported to be negative. Patient could not be reached by phone after discharge from Urgent Care about these labs. On the evening of 16-Jan-21, Police Department received a 911 call about an adult at the patient's address who was found unresponsive. Upon arrival on scene, the patient was found to be deceased and a decision was made not to attempt to resuscitate. The death was deemed to be non-suspicious and the patient's body was transported to a funeral home. On 19-Jan-21, I contacted the State Medical Examiner's Office. They have decided to perform an autopsy and have recovered the CBC and chemistry specimens obtained for further testing.",Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/14/2021,8.0,WRK,"Amlodipine, Lipitor, Lisinopril",None,"Hypertension, hyperlidemia, gout, pre-diabetes",,Nnone,"['Alanine aminotransferase normal', 'Aspartate aminotransferase increased', 'Autopsy', 'Bilirubin conjugated increased', 'Blood alkaline phosphatase increased', 'Blood bilirubin increased', 'Blood creatinine increased', 'COVID-19 pneumonia', 'Chest pain', 'Cough', 'Death', 'Electrocardiogram QT prolonged', 'Electrocardiogram abnormal', 'Full blood count', 'Liver function test', 'Lung infiltration', 'Metabolic function test', 'Metamyelocyte percentage', 'Myelocyte percentage', 'Nausea', 'Neutrophil count decreased', 'Platelet count decreased', 'Rales', 'SARS-CoV-2 test negative', 'Sinus tachycardia', 'Unresponsive to stimuli', 'White blood cell count decreased']",UNK,PFIZER\BIONTECH, 956493,MA,40.0,F,"I had two am Jan 9, chills, aches, low grade temperature. That lasted about 24 hours. Malaise - extreme -lasted the same amount of time. I took Tylenol twice.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Prenatal vitamins,no,no,,no,"['Body temperature increased', 'Chills', 'Malaise', 'Pain']",2,PFIZER\BIONTECH,IM 956504,FL,27.0,F,"27-year-old female with past medical history of anxiety, allergic to shellfish, presented for COVID-19 vaccination, developed shortness of breath after COVID-19 Moderna injection, felt lightheadedness and noted with cyanosis as per nursing, received epinephrine injection and transferred to ED. In ED she received solumedrol, benadryl and pepcid. Vitals in the ER Revealed tachycardia HR 95-105 , Sat 96% on room air not in distress. Patient was admitted for further observation",Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/16/2021,01/16/2021,0.0,PVT,"Ativan, Paxil, Birth control pills",,anxiety,,Moderna covid vaccine (new allergy); Shellfish-derived,"['Cardiac function test', 'Cyanosis', 'Differential white blood cell count', 'Dizziness', 'Dyspnoea', 'Full blood count', 'Metabolic function test', 'Tachycardia']",1,MODERNA, 956506,NJ,34.0,M,1. Shaking 2. Whole body tingling 3. Left arm tense (injection was provided in right arm) 4. Felt clammy Walked over to hospital attached to the facility and was discharged the same day. All symptoms resolved.,Not Reported,,Not Reported,Yes,1.0,Not Reported,,01/12/2021,01/12/2021,0.0,UNK,,,,,,"['Cold sweat', 'Muscle tightness', 'Paraesthesia', 'Tremor']",2,PFIZER\BIONTECH,IM 956527,MO,37.0,F,"Patient called this nurse stating she had an allergic reaction to COVID vaccination given on Friday 1/15/21. States she felt fine for the 15 minutes post immunization, was on her way home and started feeling dizzy, short of breath, chest heavy, throat felt full ""like a ball in it"". She came back to clinic which was closed but sat in the parking lot for a while. While in parking lot trying to figure out what to do, her symptoms lessened. She got home safely but started to feel jittery/shaky and her BP was very high (couldnt remember exact number). She then went to urgent care where they told her she was having an allergic reaction and given a pill of something and steroid for 6 days. Went home from urgent care and BP still high but got better at bedtime. Saturday she had a ""really bad headache and just layed around all day. I was not able to function at all."" Sunday she still had a headache and added muscle aches. Monday she started feeling ""a lot better"" until 8 PM when she was walking around doing her nightly routine and started to feel a wave of dizziness, throat felt funny so she sat down and took her BP with result of 207/131. Says this reaction felt worse than Friday's reaction so she went to ER where she was again told she was having an allergic reaction and the steroid given to her at Urgent Care was not helping and to stop taking them. Given Benadryl in the waiting room, had labs and EKG which came back ""normal"", and given a different med Vistaril to take with any future symptoms. Was also told to NOT take the second dose of COVID vaccination. Says she has not had to take the Vistaril yet and has not had any sign of reaction today so far. Said she did report the initial headache on the V-safe app.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,PVT,"Cholecalciferol, hydroxychloroquine, propranolol, norethindrone/ethinyl est/fe, folic acid.",None per patient,"HTN, RA",,"Ciprofloxacin, Tramadol","['Blood pressure increased', 'Chest discomfort', 'Dizziness', 'Dyspnoea', 'Electrocardiogram normal', 'Feeling jittery', 'Headache', 'Hypersensitivity', 'Laboratory test', 'Myalgia', 'Oropharyngeal discomfort', 'Sensation of foreign body', 'Tremor']",1,MODERNA,IM 956570,OK,36.0,F,Anaphylactic,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,"Migraines, Asthma",,"Banana, avocado, honeydew melon, cantaloupe, pineapple, yellow watermelon",['Anaphylactic reaction'],1,PFIZER\BIONTECH,IM 956578,LA,74.0,F,"At approximately 4pm on Jan 11, 2021, I began to have hard chills and fever that reached 104.9. I was admitted to ICU at the Hospital. My blood pressure dropped to dangerous levels. I was diagnosed with sepsis and the doctors determined it was caused by the vaccine.",Not Reported,,Yes,Yes,3.0,Not Reported,U,01/10/2021,01/11/2021,1.0,PVT,"Lomotil, Pantoprazole, Trametinib, Alprazolam, hydrocortisone cream, doxycycline, immodium, clindamycin, multivitamin,",Diarrhea,Stage 4 Colon Cancer,,"Sulfa, Oxaliplatin, adhesive, irinotecan","['Blood pressure decreased', 'Chills', 'Intensive care', 'Pyrexia', 'Sepsis']",1,PFIZER\BIONTECH,SYR 956589,KY,59.0,F,Tingling in arm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/24/2020,0.0,PVT,,,,,,['Paraesthesia'],UNK,MODERNA, 956597,AL,90.0,F,"Pulmonary Edema, fever, nausea, vomiting",Not Reported,,Yes,Yes,,Not Reported,N,01/18/2021,01/19/2021,1.0,PUB,Not known,none,none,,NKDA,"['Nausea', 'Pulmonary oedema', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 956615,NY,78.0,F,Two days after my wife received the moderna vaccine she showered significant cognitive impairment and memory loss . She cannot recall words and is experiencing delirium. Both her internist and her neurologist are convinced it was the result of the vaccine e. She had a complete Nueromosych evaluation done two months ago snd the results were completed normal. I want you to be aware of this snd if it does not resolve I may sue the federal government and moderna. Thanks a llot,Not Reported,,Not Reported,Not Reported,,Yes,N,01/09/2021,01/11/2021,2.0,PVT,No ne,None,None,,None,"['Amnesia', 'Aphasia', 'Blood test', 'Cognitive disorder', 'Delirium', 'Magnetic resonance imaging brain', 'Ultrasound Doppler']",2,UNKNOWN MANUFACTURER,SYR 956627,NJ,34.0,M,"Moderna COVID- 19 Vaccine. Vaccine recipient reported on 1/19/2021 that they received the Moderna Vaccine on 1/8/2021. The following week on 1/15/2021, they reported while driving, their area around their right eye became numb and they began to have blurry vision. The numbness spread to around their face/mouth. They pulled over and their spouse drove him to the hospital. Roughly 20 minutes after the initial symptoms, they developed chest pain and patient reported that the ED noted an abnormality on their EKG. The patient had to be admitted overnight for observation. The patient reported that on 1/18/2021, they still had mild chest pain and facial numbness remains around the right eye, left mouth/cheek area, and tongue. They did develop fever and a headache. The patient reported that on 1/19/2021, they are waiting on results, additional testing, and further follow-up appointment with their provider.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/08/2021,01/15/2021,7.0,WRK,"Allergy medication (unknown), albuterol Inhaler, multivitamin",None,Asthma,,seasonal allergies,"['Chest pain', 'Electrocardiogram abnormal', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia eye', 'Hypoaesthesia oral', 'Pyrexia', 'Vision blurred']",1,MODERNA, 956642,CO,44.0,F,Visited Provider appx 500 pm 1.14.2021 DVT - left calf - 2 clots via ultrasound on Eliquis now,Not Reported,,Yes,Not Reported,,Not Reported,N,01/09/2021,01/14/2021,5.0,PVT,"birth contol (over 10years same one ) trazadone, wellbutrin celexa",none,none,,penicillins,"['Deep vein thrombosis', 'Ultrasound scan abnormal']",2,PFIZER\BIONTECH,IM 956680,CT,63.0,M,Lacunar infarct (CVA) of right thalamus,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/28/2020,01/15/2021,18.0,PVT,Lisinopril 2.5 mg qd Rosuvastatin 40 mg qd Aspirin 81 mg qd Famotidine 20 mg qd Escitalopram 10 mg qd Alprazolam 0.25 mg qhs Melatonin 2.5 mg qhs Vitamin C 500 mg Vitamin D3 2000 iu qd,No active illness,CAD IFG OSA Hyperlipidemia,,NKMA,"['Angiogram', 'Computerised tomogram head', 'Echocardiogram', 'Lacunar infarction', 'Magnetic resonance imaging brain', 'Thalamic infarction']",1,MODERNA,IM 956709,TX,40.0,F,"Patient developed symptoms of Guillain-Barre syndrome on January 15, 2021 and was admitted the Hospital. She was diagnosed and eventually required ICU level care and has been treated with plasmapheresis. She is currently still in the ICU but is stable.",Not Reported,,Yes,Yes,4.0,Not Reported,N,01/08/2021,01/15/2021,7.0,MIL,,,,,,"['Guillain-Barre syndrome', 'Intensive care', 'Plasmapheresis']",1,PFIZER\BIONTECH,IM 956761,NJ,94.0,M,"Family was told that Patient expired in his sleep during the early morning hours of 1/15. I spoke with him the evening before (on 1/14), which was a day after he had received the Covid vaccine. He was not having any symptoms of allergy or reaction then. He did say that he felt tired, but he often complained of feeling tired over time.",Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/15/2021,2.0,SEN,"Eliquis, losartan, torsemide, metolazone, carvedilol, docusate",episode of congestive heart failure two months ago requiring hospitalization,"hypertension, atrial fibrillation, congestive heart failure, prior aortic valve replacement, permanent pacemaker, venous insufficiency",,none,"['Death', 'Fatigue']",1,PFIZER\BIONTECH,IM 956778,NJ,50.0,M,Hypoglycemia(40mg/dL) and required ICU admission.,Not Reported,,Not Reported,Yes,,Not Reported,,01/07/2021,01/12/2021,5.0,UNK,,,,,,"['Hypoglycaemia', 'Intensive care']",1,PFIZER\BIONTECH,IM 956811,NJ,75.0,M,"Resident was noted unresponsive, no respiration, no blood pressure, no pulse, code blue called according to facility protocol, resident is full code, CPR started, 911 called, arrived and took over from staff. Resident was pronounced dead at 1:16pm 1/18/21",Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,,01/18/2021,01/18/2021,0.0,UNK,,,,,,"['Cardio-respiratory arrest', 'Death', 'Pulse absent', 'Respiratory arrest', 'Resuscitation', 'Unresponsive to stimuli']",1,MODERNA,IM 956819,IN,31.0,F,Fullness of Throat and angioedema.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,01/19/2021,0.0,PVT,,,,,"Latex, extra precautions taken.","['Angioedema', 'Sensation of foreign body']",1,PFIZER\BIONTECH,IM 956836,CA,75.0,M,"""Patient states that he received the Covid vaccine today on left arm. Immediately after receiving it, felt his left arm went numb, then felt his lips on the left side going numb. Sensation progressed to his whole face, and down his neck, and back down to the whole left arm. He states that he even felt his truncal area, kidney, and part of his right foot going numb. States that he went to the ER for further evaluation, and while waiting there for about an hour, the sensation resolved. He denies any tingling or painful sensation. Does not think he was weak at the time.""",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/18/2021,01/18/2021,0.0,MIL,- pyrithione shampoo: uses PRN scalp irritation - cholecalciferol: pt takes 50mcg qam and 25mcg qpm - vitamin B complex 1 capsule daily,No acute illnesses.,"Chronic PMH include COPD, pulmonary nodule, thyroid nodule, vitamin D deficiency.",,"- tetanus toxoid, eggs","['Hypoaesthesia', 'Hypoaesthesia oral', 'Immediate post-injection reaction']",1,MODERNA,IM 956843,IA,71.0,M,Resident was found deceased in his bed at 7:15 am.,Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,01/17/2021,01/19/2021,2.0,SEN,Tylenol 500 Mg 2 tabs Bid; Allopurinol 100 Mg Daily; Atorvastatin 40 Mg Hs; Bumetanide 4 Mg Bid; Bupropn 150 Mg Daily; Carvedilol 3.125 Mg Bid; Cinacalcet 30 Mg Daily; Eplerenone 25 Mg Bid; Fluoxetine 40 Mg Daily; Mirtazapine 7.5 Mg Hs; Pan,No illnesses at time of vaccination or up to one month prior,Stage V Chronic Kidney Disease; Depression; Hypertension; Hyperthyroidism; Anemia; A Fib; Hyperlipidemia; Aortic Aneurysm; Neuropathy; History of Alcohol Abuse; CAD;,,NKA,['Death'],1,PFIZER\BIONTECH,SYR 956870,CA,47.0,F,"Tachycardia, Shortness of breath, headache, dizzyness, weakness, chills, nausea, fever",Not Reported,,Yes,Yes,1.0,Not Reported,N,01/02/2021,01/02/2021,0.0,SEN,,,"Migraines, ankle sprain, Sphincter of Oddi dysfunction, Irritable Bowel Syndrome",,"Atropine Sulfate, Sumatriptan Succinate","['Asthenia', 'Chills', 'Dizziness', 'Dyspnoea', 'Headache', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tachycardia']",1,PFIZER\BIONTECH,IM 956915,CA,37.0,F,"""Wheal and flare"" rash at vaccination site approx 8 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/15/2021,8.0,WRK,"Prenatal vitamins, Aspirin 81mg daily",,,,"Penicillin (hives), shellfish (hives)","['Injection site erythema', 'Injection site urticaria']",UNK,MODERNA,SC 956943,NC,54.0,F,"dose given 1/13/21, patient hospitalized with high blood sugar, hyperkalemia, hypernatremia on 1/15/21 after being lethargic with shallow breathing. Patient still hospitalized as of 1/19/21 and diagnosed with Diabetes",Not Reported,,Not Reported,Yes,,Not Reported,N,01/13/2021,01/15/2021,2.0,PHM,,,,,,"['Blood glucose increased', 'Diabetes mellitus', 'Hyperkalaemia', 'Hypernatraemia', 'Hypopnoea', 'Lethargy']",1,MODERNA,IM 956956,CA,44.0,F,"Severe dissociative event (psychotic break) beginning <72hr after administration of vaccine, and continuing another 48 hours before resolution. Patient has no prior adverse psychiatric history. Transported to local ER on Monday 11th upon worsening of condition. Administered Haldol in the ER as a sedative after becoming combative during dissociative state. Patient woke up Tuesday the 12th with recurrent, but significantly diminished, dissociation, which had largely resolved by late Tuesday. Patient transported to Mental Health on a 5150. Released Friday the 15th around noon. No recurrent symptoms since.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/07/2021,01/11/2021,4.0,PVT,"Women's multivitamin Women's probiotic Cod Liver Oil Vitamin D3 gummies OsteoBiflex B complex THC gummies, 2.5mg one dose Milk kefir L-theanine",,"GERD, asthma",,"Cephalosporin, coedine","['Aggression', 'Computerised tomogram normal', 'Dissociative disorder', 'Toxicologic test normal']",1,MODERNA,IM 956957,TN,88.0,F,Resident reported she didn't feel well. She started running a fever of 103. Resident complained her stomach and genitals were burning and pain in her legs. Resident has been vomiting today and diarrhea. EMS was called and resident transported to Hospital today 1/19/21,Not Reported,,Not Reported,Yes,,Not Reported,N,01/18/2021,01/18/2021,0.0,SEN,,,,,,"['Diarrhoea', 'Dyspepsia', 'Genital burning sensation', 'Malaise', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 956962,NY,74.0,M,"COVID 19 vaccine, unknown which company Chronically ill in a skilled nursing facility found diaphoretic, hypotensive, hypoxia to 85% arrived to Emergency dept in cardiac arrest Died within 65 minutes of nursing finding patient in distress Wife felt it may have been related to vaccine date of vaccination 1/6/20 hx covid 19 PNA in April 2020",Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/19/2021,13.0,PVT,Unavail,CVA seizure disorder all chronic HTN CAD had COVID 19 in April 2020,as above PAtient had accute respiratory distress followed prolptly by cardiac arrest,,NKDA,"['Cardiac arrest', 'Death', 'Hyperhidrosis', 'Hypotension', 'Hypoxia']",1,UNKNOWN MANUFACTURER,UN 956965,VA,32.0,F,"Around 9 pm, my arm became more sore and started radiating into my shoulder and I had chills. I had a low-grade fever and I had slight SOB. Not sure if it was due to vaccine or the fact that I'm big and pregnant. The next more I was extremely sore all over. I also experienced major fatigue and a headache. I just rested and felt better afterwards and it went away.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,Prenatal vitamins,Had COVID in December.,,,,"['Arthralgia', 'Chills', 'Dyspnoea', 'Exposure during pregnancy', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 956994,CA,73.0,M,"The patient had severe shortness of breath resulting in cardiac arrest on the 5th day after the vaccine. Shortness of breath started 12 hours after injection. On the 5th day, the patient was discovered to also have a rash throughout his body, but it is unknown when this rash started.",Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,PVT,"Cholecalciferol, duloxetine, fenofibrate, gabapentin, hydrocortisone suppository, melatonin, metformin, metoprolol succinate, mineral oil, nitroglycerin, omeprazole, pravastatin, quetiapine, selenium sulfide shampoo, quetiapine, sumatriptan",,"Hypertension, Type II diabetes, hyperlipidemia, GERD",,"Aspirin, penicillin, vicodin, acetaminophen, niacin","['Cardiac arrest', 'Dyspnoea', 'Rash']",1,MODERNA,IM 957061,OH,39.0,F,"Pt is 39 y/o female. Pt is casual RN for ED. Pt received COVID-19 vaccination here on the 23rd of December. Pt began feeling weak on the 17th of January. On the 18, Pt began experiencing numbness and tingling in hands and feet. Pt has been seen at facility and her PCP prior to coming to ED. Pt PCP called me and told me she is concerned that the Pt might have Guillain Barre syndrome and referred her here. Pt now c/o numbness and tingling from feet to mid abdomen and numbness/tingling up entire arm. IV was established and labs drawn, CT Head normal. Pt to IR for LP for definitive Dx of Guillain Berre. Pt admitted to room 202. Director of ED notified.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/23/2020,01/17/2021,25.0,PVT,unknown,unknown,hypothyroid,,nkda,"['Asthenia', 'Blood test', 'Computerised tomogram head normal', 'Hypoaesthesia', 'Lumbar puncture', 'Paraesthesia']",1,MODERNA,IM 957091,NC,72.0,M,COVID-19 Vaccine,Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/14/2021,01/15/2021,1.0,MIL,"Lantis, Novolog, ferrous sulfate, metformin, juardance, eloquis,tamulosin, vitamin D3, Metropolol, lisinopril, atorvastatin,omeprazole, finesteride, potassium , centrum 50+","Removal of sebaceous cyst,",High blood pressure Diabetes Schizophrenia p Triple bypass Gerd,,Serentil,"['Angiogram', 'Computerised tomogram', 'Magnetic resonance imaging', 'Unevaluable event']",1,MODERNA,IM 957116,HI,75.0,M,Sudden death without warning symptoms 4 days after vaccine. Many medical problems which most likely explain the outcome but spouse feels it is related and it is a new vaccine. Monitor for pattern?,Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/18/2021,4.0,MIL,"Atovastatin, Ferrous sulfate, Finasteride, Flomax, Humulin N, Pantoprazole, ProAir, Reglan, Spiriva, Turmeric","Diabetes, Chronic renal failure on hemodialysis, Atrial fibrillation, Quadriplegia, Thrombocytopenia, Gastroparesis, Vitamin D deficiency, BPH, Neurogenic bladder, distant history of small intestine carcinoid tumor, right cerebral artery aneurysm, Barrett's esophagus, MGUS, Hypertension, obstructive sleep apnea, Pulmonary hypertension, Junctional tachycardia.",see above. Sudden death without warning likely due to medical problems above but spouse feels it was somehow related to the vaccine 4 days before and it is a new vaccine.,,"Cipro caused nausea, Coreg caused bradycardia, Hydrocodone, calcium acetate",['Sudden death'],UNK,MODERNA,IM 957147,NY,56.0,M,"Excruciating abdominal pain, left arm pain, chest pain. Gangrenous appendicitis requiring emergency surgery and followed by admission for complicated acute abdomen.",Not Reported,,Not Reported,Yes,14.0,Yes,N,12/29/2020,01/02/2021,4.0,PVT,none,none,GERD,,none,"['Abdominal pain', 'Acute abdomen', 'Blood test', 'Chest pain', 'Complicated appendicitis', 'Computerised tomogram abdomen', 'Computerised tomogram thorax', 'Pain in extremity', 'Surgery', 'Ultrasound scan']",1,MODERNA,IM 957159,NJ,65.0,M,"Resident experienced chest pain the evening he received the vaccine and requested to go to the hospital as he stated his ""chest is pounding"".",Not Reported,,Not Reported,Yes,,Not Reported,,12/29/2020,12/29/2020,0.0,UNK,,,,,,"['Chest pain', 'Palpitations']",1,PFIZER\BIONTECH,IM 957163,NJ,54.0,M,"Resident received 1st on 1/11/21 at 12:10am (1/12/21) resident was found unresponsive. Code Blue, 911 called at 12:11am. FD and EMS arrived, resident pronounced at 12:51am.",Yes,01/12/2021,Not Reported,Not Reported,,Not Reported,,01/11/2021,01/11/2021,0.0,UNK,,,,,,"['Cardio-respiratory arrest', 'Death', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 957171,NJ,45.0,F,"24 hours after the vaccine administration, patient began experiencing respiratory (asthma) symptoms. She was treated with nubulizer treatment and albuterol HFA inhaler.",Not Reported,,Not Reported,Yes,,Not Reported,,01/08/2021,01/09/2021,1.0,UNK,,,,,,"['Asthma', 'Respiratory symptom']",1,PFIZER\BIONTECH,IM 957227,CA,63.0,M,"Hypotension, Prolonged seizure with bowel incontinence, cough, weakness and delirium, resulting in 911 transport and admission to hospital for intubation and mechanical ventilation for acute respiratory hypoxia.",Not Reported,,Not Reported,Yes,10.0,Not Reported,Y,01/08/2021,01/09/2021,1.0,OTH,see continuation sheet,"seizure d\o, toothache","seizure d\o, HTN, Backpain r\t old fx and compression, sciatica, CAD, pseudoseizures, major depression",,"iodine cotnrast, oxalic acid, haldol","['Anal incontinence', 'Asthenia', 'Chest X-ray', 'Computerised tomogram head', 'Cough', 'Delirium', 'Echocardiogram', 'Endotracheal intubation', 'Full blood count', 'Hypotension', 'Hypoxia', 'Liver function test', 'Mechanical ventilation', 'Metabolic function test', 'Seizure']",1,MODERNA,IM 957249,TX,42.0,F,Sunday evening developed lower pelvic pressure which continued to Tuesday. Called my OB MFM office and was instructed to come in for a check up. I am currently 18wks 4 days (was exactly 18 weeks on date I received dose 2). At the OB MFM clinic I was discovered to have a shortened cervix of 2cm. I did not have this occur in my prior term pregnancy. Although there may be no causal link I felt it important to report as there may be an association with the vaccine and cervical length/risk of preterm delivery.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/17/2021,2.0,PVT,"Lovenox, 81mg aspirin, plaquenil, omega 3, prenatal vitamin, folic acid",None,"Antiphospholipid antibody (partial), sjogrens antibody, sickle cell trait",,Phenergan,"['Abdominal discomfort', 'Exposure during pregnancy', 'Shortened cervix', 'Ultrasound scan abnormal']",2,PFIZER\BIONTECH,IM 957282,TX,62.0,M,Appendicitis,Not Reported,,Yes,Yes,1.0,Not Reported,Y,12/28/2020,01/11/2021,14.0,SCH,"Phenytoin olmesartan, sinvastarin",None,Hypertension controlled Temporal lobe epilepsy no seizures,,None,['Appendicitis'],UNK,PFIZER\BIONTECH, 959927,,78.0,M,"short of breath Narrative: patient complained of shortness of breath prior to getting covid vaccine, patient and wife stating it was his norm. After vaccine he complained of increasing shortness of breath, and hypoxic with bluish nail beds, lips, and greyish in color. Applied O2 via mask, and nail beds, lips, and facial color returned, sent patient to local ER for treatment and evaluation.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/19/2021,01/19/2021,0.0,OTH,,,,,,"['Condition aggravated', 'Cyanosis', 'Dyspnoea', 'Hypoxia', 'Skin discolouration']",1,MODERNA,IM 957333,NC,,F,"received first dose of COVID vaccine on 18Dec2020 and tested positive on 30Dec2020; received first dose of COVID vaccine on 18Dec2020 and tested positive on 30Dec2020; she had a 5 day migraine after the first dose; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date were unknown), via an unspecified route of administration on 18Dec2020 at first single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of COVID vaccine on 18Dec2020 and tested positive on 30Dec2020. The patient stated her isolation will be over the day that she was to receive her second dose. The patient stated that she had a 5-day migraine after the first dose. Outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up (06Jan2021): New information received in response to query via mail includes confirmation of the primary reporter's last name. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,12/01/2020,,UNK,,,,,,"['Migraine', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 957339,MA,,M,"Patient suffered many black occasional flash dots, flashes and floaters in his left eye and went for an urgent eye exam. Plaintiff was diagnosed with posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye.; Patient suffered many black occasional flash dots, flashes and floaters in his left eye and went for an urgent eye exam. Plaintiff was diagnosed with posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye.; Patient suffered many black occasional flash dots, flashes and floaters in his left eye and went for an urgent eye exam. Plaintiff was diagnosed with posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye.|1; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or around 19-AUG-2014, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) (anatomical location, administration route, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving the vaccine, the patient suffered many black occasional flash dots, flashes and floaters in his left eye and went for an urgent eye exam. Later, the patient was diagnosed with posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) vaccine, mental an emotional distress due to resulting physical limitations and seriousness of his condition; the patient sustained severe and permanent personal injuries. Patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. At the time of the report, the outcome of posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye was not recovered. The reporter considered the posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye to be related to Zoster Vaccine Live (ZOSTAVAX). The events of posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye were considered to be disabling. Upon internal review, the posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye were considered as medically significant event.",Not Reported,,Not Reported,Not Reported,,Yes,N,08/19/2014,,,UNK,,,,,,"['Photopsia', 'Retinal tear', 'Visual impairment', 'Vitreous detachment', 'Vitreous floaters', 'Vitreous haemorrhage']",UNK,MERCK & CO. INC., 957340,AL,,M,"post-herpetic neuralgia; skin lesions developed on his head and forehead; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information regarding current condition, historical condition or concomitant medication was not reported. In or around February 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) being administered, the pt developed skin lesions on his head and forehead, and this resulted in post-herpetic neuralgia in his upper body, particularly the shoulders, that also persisted to the present. The pt first learned of the link between zoster vaccine live (ZOSTAVAX) and injuries such those from which he (also reported as she, conflicting information) suffered, on or about 22-DEC-2018, when a friend shared information found on website. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not presented prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causality between the events and zoster vaccine live (ZOSTAVAX) was considered as related. Skin lesions and post-herpetic neuralgia were considered as disabling.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/01/2016,,,UNK,,Routine health maintenance,,,,"['Post herpetic neuralgia', 'Skin lesion']",UNK,MERCK & CO. INC.,OT 957385,,,F,"tested positive after 1st dose; tested positive after 1st dose; This is a spontaneous report from a contactable nurse reporting for herself. This nurse reported similar events for 2 patients: this is the first of two reports. This 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient tested positive after first dose. Outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021021888 same reporter/drug/AE, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 957388,,,M,"Between then and now I tested positive; Between then and now I tested positive; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, ""I have taken the vaccine (1st dose) on 28Dec2020 at the hospital. Between then and now I tested positive on the 04Jan2021, the hospital sent me home for 2 weeks. The 2nd part of the vaccine is coming up, it isn't until the 18Jan2021."" The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,PVT,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 957416,TX,40.0,F,"Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, left arm pain; jaw pain; This is a spontaneous report from a contactable other Health Professional (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EX5170), via an unspecified route of administration on 16Dec2020 15:00 at single dose in left arm for covid-19 immunization. Medical history included symptomatic PVC's (Premature ventricular contractions), tachycardia, bradycardia, CVA (cerebrovascular accident) from 2018 to an unknown date, asthma and rhythm. Concomitant medication included flecainide, spironolactone, metoprolol for rhythm. The patient had known allergies included hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and adhesive. Prior vaccination, the patient had no covid. On 22Dec2020 18:00, the patient experienced hypertensive Emergency (BP 219/114) with no previous blood pressure issues. Radiating chest pain, left arm pain, and jaw pain. Admitted to the hospital where an echocardiogram and angiogram was performed showing clear coronary arteries and no hypertensive remodeling of the heart. Issue has been ongoing since, despite interventions. The events result in emergency room/department or urgent care and hospitalization from an unspecified date for 1 day. The patient received the treatment for the events included frequent nitroglycerin, hydralazine and metoprolol. The patient underwent curative-SARS-Cov-2 Assay RT-PCR on 01Jan2021 with negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, contributory role of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,) to event ""hypertensive emergency (BP 219/114) with no previous blood pressure issues"" cannot be excluded. The events chest pain and pain in jaw are attributed to underlying medical conditions and assessed unrelated. BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/16/2020,12/22/2020,6.0,PVT,; ;,,Medical History/Concurrent Conditions: Adhesive tape allergy; Asthma; Bradycardia; CVA; Heart rate abnormal; Premature ventricular contractions; Tachycardia,,,"['Arteriogram coronary normal', 'Chest pain', 'Echocardiogram normal', 'Hypertensive emergency', 'Pain', 'Pain in extremity', 'Pain in jaw', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 957428,MO,,F,"having symptoms, tested covid+(positive); having symptoms, tested covid+(positive); This is a spontaneous report from a contactable consumer (patient). This 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 17Dec2020 at single dose for COVID-19 immunization. No relevant medical history and concomitant medications were provided. The patient started having symptoms on 23Dec2020 and she was tested for COVID 19 on 27Dec2020 and resulted positive. The outcome of the event was unknown. Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015240 Same patient/reporter, 2nd dose of drug, different AE",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/27/2020,10.0,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 957441,CA,,U,"tested + 9 days after dose #1; tested + 9 days after dose #1; exposed to Covid-19 four days after vaccination; This is a spontaneous report from a contactable patient. A patient of unknown age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 26Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient was exposed to Covid-19 four days after vaccination and tested positive (+) nine days after dose 1 on 04Jan2021. The patient would like the advice for receiving the second dose. Outcome was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/30/2020,4.0,UNK,,,,,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 957454,LA,82.0,M,"I still have uncomfortable feeling in my arm/I was finally able to raise it above my head, my left arm, after two days but it was not comfortable to do it, it was painful; I have severe pain in my arm/it started hurting and then it continued to get worse and worse and it was severe; It was the worst pain I have ever had and I could not move my arm; It continued to get worse and that night I went to bed and I cannot sleep, it hurts so bad/I could not sleep on the right side or on a left side; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date was not provided), via an unspecified route of administration (left arm) first dose on 30Dec2020 10:30 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that I had the vaccine back a week and half ago on 30Dec2020 and was due to get the booster this month and wanted to report severe pain arm for two days. The patient stated that he had many vaccine (Unspecified Vaccine) over the years and have never had anything that hurts so bad after about six hours. The patient just wanted to know that was that normal. Consumer further stated, ""I took the vaccine about 10:30 in the morning and about four hours later, it started getting sore but that thing was normal you know some vaccines (Unspecified Vaccine) do that but along with that it started hurting about four hours after the vaccine and it continued to get worse and that night I went to bed and I cannot sleep, it hurts so bad. The patient even have thoughts about getting up and go in to the emergency room. It was the worst pain I have ever had and I could not move my arm. I could not sleep on the right side or on a left side and all I did was take Tylenol as prescribed and that helped a little bit but not much but I did not go to the emergency room, I am not going to do that but I felt like it because it hurts so bad but I made it through the night and next day it continued to hurt really bad. I just keep taking Tylenol every four hours and that continued for two days and then finally I was able to raise my arm up above my head without little pain, it was discomfort, but it was not hurting so bad."" The patient stated that the event started about two hours later it started, it started hurting and then it continued to get worse and worse and it was severe, that is the reason why I am calling that it was severe. I wanted a shot or morphine to relieve myself that how bad it was."" (no clarified further). The patient stated that the vaccine was given in my left arm only about one inch below the top of my shoulder which I think that might have been the problem, I don't know if you can answer that or not but I have never received the vaccine or shot anywhere near that area, it is always three or four inches down in my muscle, on my arm either on left or right, this was given in my left arm but this was given almost in my joint I am wondering if that would cause pain."" The patient stated it was given only one inch below the tip above shoulder may be that is causing so much pain."" The patient just wanted to report the severe pain, that was for two whole days and then it was subsided and it lasted for four days and I still have uncomfortable feeling in my arm. I was finally able to raise it above my head, my left arm, after two days but it was not comfortable to do it, it was painful."" The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Injected limb mobility decreased', 'Limb discomfort', 'Pain', 'Pain in extremity', 'Product administered at inappropriate site', 'Sleep disorder']",1,PFIZER\BIONTECH, 957458,,,U,"Spot on arm where I got the vaccine probably 4 days ago is continuing to increase in size and is red, swollen and hard; it's huge and it's purple and red and it feels like bee sting, it feels like an allergic reaction; purple and red; continuing to increase in size and it is red and swollen and hard now; Made me really, really sick like bedridden for 2 days; Spot on arm where I got the vaccine probably 4 days ago is continuing to increase in size and is red, swollen and hard; This is a spontaneous report from a contactable Other HCP (patient). An unknown age and gender patient received BNT162B2 (lot# unknown) on Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Patient stated, ""I just have a question, my Pfizer COVID Vaccine made me really, really sick like bedridden for 2 days which I am finding out is probably normal. But the spot on my arm where I got the vaccine, it was probably 4 days ago that I got it and it's continuing to increase in size and it is red and swollen and hard now. Like I am a Nurse Practitioner, this is not like a normal injection site reaction, it's huge and it's purple and red and it feels like bee sting, it feels like an allergic reaction, should I be concerned, do I need to go to the hospital?"" Outcome of the event was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['Injection site discomfort', 'Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Malaise']",UNK,PFIZER\BIONTECH, 957461,AR,42.0,F,"Tested positive for Covid/had the (Covid) infection; Tested positive for Covid/had the (Covid) infection; Swollen lymph nodes under my right arm; This is a spontaneous report from a contactable nurse. This 42-year-old female nurse (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: nurse stated she thought she had a lot# it looked like EK5703), via unspecified route at right deltoid on 21Dec2020 at single dose for COVID-19 immunization. Medical history included blood pressure (patient had taken blood pressure medicine but hadn't taking currently because her blood pressure was being controlled). Concomitant medications included unspecified vitamins. Patient was tested positive for Covid on the 29Dec2020. She stated she didn't know about causality, she was saying no but she did have swollen lymph nodes under the right arm before getting sick (Dec2020), now she thought that might get from her vaccination but in her understanding she could get it from Covid so, she couldn't answer that, she tested positive, she didn't think it's from vaccination but her concern was because she had got the vaccination the first one then had the (Covid) infection and right now she should get the second one or not. Regarding treatment, patient stated she was taking methylprednisolone sodium succinate (SOLU-MEDROL) and salbutamol (ALBUTEROL) inhaler, taking over the counter Vitamin D3, Zinc and Vitamin C and acetylsalicylic acid (ASPIRIN). Patient reported she did go to the physician office/ emergency room. Outcome of events was unknown.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (8 days in this case). However, a causal relationship between events ""Tested positive for Covid/had the (Covid) infection"" (coded to Drug ineffective / COVID-19) and swollen lymph nodes and BNT162B2 vaccine cannot be completely excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/01/2020,,UNK,,,Medical History/Concurrent Conditions: Blood pressure abnormal (had taken blood pressure medicine blood pressure was being controlled),,,"['Lymphadenopathy', 'Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 957467,PA,60.0,U,"loss of vision in left eye; herpes zoster; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 05-JUL-2011 at the age of approximately 60 years old, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by a health care provider (reported as provider) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster and loss of vision in left eye. The outcome of the events was not reported. Upon internal review, loss of vision in left eye was determined to be medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,07/05/2011,,,UNK,,,,,,"['Blindness unilateral', 'Herpes zoster']",UNK,MERCK & CO. INC.,OT 957555,NY,38.0,M,"I am a registered nurse at hospital. On 12/25, seven days after receiving the shot I started to get right lower leg pain and I kept complaining about it till New Years Day. I had no symptoms of a DVT. I triaged on 1/1/21 and the doctors ordered labs/imaging and the results were as followed: D-Dimer biomarker (+) , Ultrasound of the Rt lower leg ( - ) , CTA showed a PE (segmental right upper lobe pulmonary artery consistent with pulmonary embolus). I was discharged on Xarelto and advised to follow up with a hematologist. On 1/5/2021, I went to hematology and they did a whole bunch of labs. I was sent to get a ultrasound of the leg because the pain persist and they found a clot hidden by my soleus. The plan is to continue on the Xarelto for 6 months. Come back in 3 weeks to scan my leg again and get my lab results. On 1/12/2021, I received the 2nd shot of the Pfizer vaccination.",Not Reported,,Yes,Not Reported,,Not Reported,Y,10/02/1982,01/01/2021,13971.0,PVT,"Vitamin D, Zinc, Descovy",,,,PCN,"['Angiogram pulmonary abnormal', 'Fibrin D dimer increased', 'Pain in extremity', 'Pulmonary embolism', 'Thrombosis', 'Ultrasound scan abnormal']",1,PFIZER\BIONTECH,IM 957627,OH,38.0,F,I received the vaccine on 1/15/21. I was 12 weeks and 4 days pregnant. My cell free DNA testing was normal that week and it was a boy. My ultrasound 4 days prior was normal too. On 1/19/21 the baby did not have a heartbeat. My EDD was 7/26/21,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/19/2021,4.0,PVT,"Effexor, prenatal vitamins",None,Anxiety,,None,"['Foetal heart rate abnormal', 'Prenatal screening test', 'Ultrasound scan normal']",1,MODERNA,SYR 957744,,59.0,F,Patient lost vision in the left eye and was treated for optic neuritis. Patient still has vision loss in the left eye,Not Reported,,Not Reported,Yes,10.0,Yes,,09/15/2020,11/05/2020,51.0,PHM,,,"Type II Diabetes, Hypothyroidism",,,"['Blindness', 'Optic neuritis']",UNK,"SEQIRUS, INC.",IM 957763,IA,29.0,M,"Client was administer 2nd dose of Moderna COVID-19 vaccine at 1:32pm. Client reported has ""sore arm from first dose"", but denied any other issues from 1st dose. At 1:44pm, client reported was feeling flushed and slightly dizzy/light headed. Client appeared flushed, clammy and was slightly confused. Client was sitting in chair and was assisted to the floor and clinical assist code was called. VS were: BP: 149/84 and pulse ox was 97% on RA. Initially, HR was in the low 30's, but after lying down, came up to 86 and stayed in the 80-90's during assist. Client began to report chest tightness and feeling foggy and remained slightly confused and at times speech was garbled. Client denies sensation of throat closing and denied shortness of breath. Client was assisted to a cot and transported by ER staff and MD to the ER for evaluation.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/19/2021,01/19/2021,0.0,PUB,unknown,none,none,,NKA,"['Cardiovascular evaluation', 'Chest X-ray', 'Chest discomfort', 'Cold sweat', 'Confusional state', 'Dizziness', 'Feeling abnormal', 'Flushing', 'Heart rate decreased', 'Heart rate irregular', 'Laboratory test', 'Speech disorder']",2,MODERNA,IM 957792,MN,32.0,F,"Just left arm soreness, just wanted to let you know I was 9 weeks pregnant when I got the vaccine, EDD is 8/3/2021, I knowingly got the vaccine, but wanted to let you know for tracking purposes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,prenatal vitamin,no,"obesity (BMI 31), chronic HTN not on meds",,no,"['Exposure during pregnancy', 'Pain in extremity']",UNK,MODERNA,IM 957799,VA,81.0,M,"Presented to Urgent Care for weakness and confusion, transferred to ED, patient had a cardiac arrest and was unable to be resuscitated",Yes,01/15/2021,Not Reported,Yes,,Not Reported,N,01/14/2021,01/15/2021,1.0,PVT,"sotaloL (BETAPACE) 80 mg Tablet omeprazole (PRILOSEC) 20 mg Capsule, Delayed Release(E.C.) sevelamer carbonate (RENVELA) 800 mg Tablet polyethylene glycol 3350 (MIRALAX PO) acetaminophen (TYLENOL EXTRA STRENGTH PO) fluticasone propionate (F",,HTN AAA with endovascular stent ESRD COPD,,Lipitor,"['Asthenia', 'Cardiac arrest', 'Confusional state', 'Death', 'Electrocardiogram', 'Full blood count normal', 'Metabolic function test', 'Troponin normal']",1,MODERNA,IM 957860,,49.0,F,"""I received the Pfizer Covid vaccine Wed afternoon around 4pm. Thursday morning around 9:30 I started with severe pain in my left leg. The pain worsened through the day and my leg began swelling. No other symptoms at all. This morning my leg was twice the size of my right leg so I went to the ER. I live in so I'm at ED. I have a massive blood clot running the the length of my leg - from my thigh to my ankle. I'm very lucky I got here so fast! I?m a very healthy 49 year old with no history of DVT or blood clots so they dug further to find out why. A cat scan showed I have a congenital condition called May Thurner Syndrome. I?m so relieved to have an answer and it?s fixable! The vascular doctors are not 100% convinced that?s not all that was going on as I was born with the syndrome and I?ve gone this long without a clot. So they are doing lots of labs to see if anything else shows up. This is where we are at. I?m being admitted to take care of the clot.""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,PVT,acetaminophen (Tylenol) 500 mg Tablet cephALEXin (Keflex) 500 mg Capsule rivaroxaban (Xarelto) 15 mg Tablet desvenlafaxine succinate (Pristiq) 25 mg Tablet Sustained Release 24 hr levothyroxine (Synthroid) 100 mcg Tablet Dupixent,None,None,,Compazine [Prochlorperazine Edisylate] Pcn [Penicillins]Rash Sulfa (Sulfonamide Antibiotics) TerconazoleOther (See Comments),"['Computerised tomogram abnormal', 'Condition aggravated', 'May-Thurner syndrome', 'Pain in extremity', 'Peripheral swelling', 'Thrombosis']",1,PFIZER\BIONTECH,IM 957865,MI,67.0,F,Pt woke up with tongue swelling morning following her vaccine. Was admitted for angioedema.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/18/2021,01/19/2021,1.0,PHM,"benazepril, metoprolol, metformin, gemfibrizol, amlodipine, levothyroxine, pravastatin",None,"Diabetes type 2, HTN, hyperlipidemia, hypothyroid",,Penicillin,"['Angioedema', 'Blood calcium normal', 'Blood chloride increased', 'Blood creatinine increased', 'Blood glucose normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea increased', 'Carbon dioxide decreased', 'Glomerular filtration rate decreased', 'Haematocrit normal', 'Haemoglobin normal', 'Mean cell haemoglobin concentration normal', 'Mean cell volume normal', 'Platelet count normal', 'Red blood cell count normal', 'Red cell distribution width normal', 'Swollen tongue', 'White blood cell count normal']",1,MODERNA,IM 957999,AZ,35.0,F,Sore arm and headache.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,PUB,"Vitamin d, prenatal vitamins and probiotic.",No illness.,,,"Corn, melon and nut allergy.","['Headache', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 958012,MO,61.0,F,"Rapid heart Rate that began about 12 hours after the injection. Heart rate of 123 all night and went to ER next morning after calling Nurse on Call system. I was admitted and the Dr ordered bag after bag of fluids to and kept me in the unit overnight for observation. Did may hear tests (EKG, ECHO STRESS,CTA chest) and results all came back good. I was released on 1/19/21 at 2pm and my hear rate is back to normal (82 bpm).",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/17/2021,01/17/2021,0.0,PVT,"Clariton Allergy (daily) Vitamins = Calcium, D3, Zinc, Magnesium, C, Alive for women (1/2 daily dose) Fish oil",,None,,none that I'm aware,"['Angiogram', 'Blood magnesium', 'Blood thyroid stimulating hormone', 'Chest X-ray', 'Differential white blood cell count', 'Electrocardiogram normal', 'Fibrin D dimer', 'Full blood count', 'Heart rate increased', 'Metabolic function test', 'Scan with contrast normal', 'Stress echocardiogram normal', 'Toxicologic test', 'Troponin', 'Urine analysis']",1,PFIZER\BIONTECH,IM 958054,CT,25.0,F,Extreme fatigue since getting shot - effecting ability to work,Not Reported,,Not Reported,Not Reported,,Yes,N,01/02/2021,01/03/2021,1.0,UNK,Xyzal (occationally) multivitamin,None,Lyme disease ( possible),,"Wellbutrin , tree nuts","['Fatigue', 'Impaired work ability', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 958069,FL,94.0,F,"Started with cough, mild shortness of breath and feeling terrible in evening of 1/19.",Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/19/2021,5.0,PVT,"Cartia XT 120mg daily, Zaditor 0.025% 1 drop into eye twice a day, Folic Acid 1mg daily, Metoprolol Succinate ER 100mg twice a day, Lasix 40mg daily, Erythromycin 2% to area twice a day, Hydroxychloroquine Sulfate 200mg 2 tabs daily, Ferrou",None,"Rheumatoid arthritis, osteoarthritis, lumbar spinal stenosis, diabetes, bradycardia with pacemaker",,Codeine,"['Cough', 'Dyspnoea', 'Feeling abnormal']",1,MODERNA,IM 958072,,57.0,F,"Death 3 days after receiving 2nd dose of COVID vaccine, unknown if related to vaccine administration.",Yes,01/19/2021,Not Reported,Yes,,Not Reported,,01/16/2021,01/18/2021,2.0,WRK,,,,,,['Death'],2,PFIZER\BIONTECH,IM 958137,NY,43.0,M,"Developed hives a few hours after shot, with swollen lips that progressed into the evening on the 30th. Worse on the 31st, went to urgent care given IV cortisone and pepcid symptoms resolved, discharged in the early afternoon, 2 hours after dc symptoms returned to cover face with lump in throat. 911 contact and taken by ambulance to Medical Center ER, admitted over night and discharged on 11/1 to home still with full body hives. 11/2 had consults with primary MD and allergist MD, given regimen of predisone taper 60 mg over 10 days along with pepcid, zyrtec . Full body hives began to resolve of 11/3, returned to work on 11/4, intermittant hives persisted on/off for 4 weeks, currently still taking pepcid and zyrtec.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,10/30/2020,10/30/2020,0.0,WRK,zyrtec PRN Nexium 20 mg every other day,no,"previous hx of chronic urticaria,",,sulfa drugs augmentin,"['Lip swelling', 'Sensation of foreign body', 'Urticaria']",1,GLAXOSMITHKLINE BIOLOGICALS,IM 958175,NY,71.0,F,"Approximately after 20 minutes after vaccine administration, my throat felt numb and i could not swallow my saliva, no acute breathing difficulty , I could not swallow water , I was very anxious and went back to facility I got vaccine , The attending doctor administered Benadryl I 50 mg IM , and then EPI 0.3 mg . EMT was called , and ED at Hospital i was attended , and Solumedrol 1.25 mg was administered IV and Pepsid for GERD , i also had, I was observed for a few HRs and skript for Prednisone and Benadryl was issued. I was then feeling better,",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/19/2021,01/19/2021,0.0,OTH,"Plavix, Lipitor, Fish oil ,multivitamins",No illnesses,"CAD, hx of Colon Ca in remission",,"Aspirin Motrin, Beef , pork and lamb","['Anxiety', 'Dysphagia', 'Electrocardiogram', 'Gastrooesophageal reflux disease', 'Pharyngeal hypoaesthesia']",1,MODERNA,IM 958208,TX,69.0,F,"My arm was a little sore after the vaccination but no other symptoms. And on 12/30 I woke up with a sever fever, vomiting and diarreah. Went to the ER and was diagnosed with CHF because my feet were so swollen and was given lasix and released. I continued to feel bad so on that Sunday 1/3 I went back to the hospital and was admitted and tested positive for COVID-19. I spent from Sun-Wed in the hospital",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,12/28/2020,12/30/2020,2.0,PVT,"Levothyroxine 125mg, Simvastatin 40mg, Estradiol .05mg, Potassium Chloride 20mg, Furosemide 20mg, Metroprol 100mg., Asminex 1puff bid, Gavipitman, Ferrous Sulfate 324mg, Vit C, Fish Oil 1000 mg bid, Lexapril 20mg.,",no,"COPD, Congestive Heart Failure, Asthma",Shingles-2016,"oranges, watermelon, chicken","['Cardiac failure congestive', 'Condition aggravated', 'Diarrhoea', 'Feeling abnormal', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'SARS-CoV-2 test positive', 'Vomiting']",1,MODERNA,IM 958228,IL,83.0,M,"Patient has end stage renal disease and rapidly worsening dementia, family could no longer care for him at home, and he was admitted for 14-day quarantine prior to admission to inpatient hospice. Received vaccine on 1/12 without apparent adverse reactions. Patient started refusing oral intake on 1/16, and CMP on 1/17 showed hypernatremia 165 (new issue). His BUN 138 CREAT 6.93 K 5.2 were his baseline. He was found to be deceased on 1/18 at 11:18 pm.",Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/18/2021,6.0,PVT,"1) AMLODIPINE BESYLATE TAB 5MG PO QPM ACTIVE 2) ASPIRIN (OTC) TAB,CHEWABLE 81MG PO QDAILY ACTIVE 3) CARVEDILOL TAB 12.5MG PO BID ACTIVE 4) CHOLECALCIFEROL (VIT D3) 25MCG=100",none other than chronic conditions as listed under item 12.,"acute on chronic kidney failure, Alzheimer's dementia, diabetes mellitus type II, hypothyroidism, bipolar disorder, hypertension, hyperlipidemia",,Niacin - rash,"['Alanine aminotransferase normal', 'Anion gap', 'Aspartate aminotransferase normal', 'Blood albumin decreased', 'Blood alkaline phosphatase increased', 'Blood bilirubin normal', 'Blood calcium normal', 'Blood chloride increased', 'Blood creatinine increased', 'Blood glucose increased', 'Blood potassium increased', 'Blood sodium increased', 'Blood urea increased', 'Carbon dioxide decreased', 'Death', 'Diet refusal', 'Hypernatraemia', 'Metabolic function test', 'Protein total normal']",1,MODERNA,IM 958235,MS,57.0,F,"Pt found unresponsive at home, respiratory distress. Had reported nausea and vointing for two days prior to admit which started 1/15. Acute metabolic encephalopathy and acute renal failure Currently at time of this report still in critical care",Not Reported,,Yes,Yes,,Not Reported,N,01/13/2021,01/17/2021,4.0,PVT,Jardiance Metformin Novolog scale Ozempic,diabetes,Diabetes,,Toradal and protonix,"['Acute kidney injury', 'Chest X-ray', 'Computerised tomogram', 'Diabetic ketoacidosis', 'Intensive care', 'Metabolic function test', 'Nausea', 'Renal function test', 'Respiratory distress', 'Toxic encephalopathy', 'Unresponsive to stimuli', 'Vomiting']",1,MODERNA,IM 958322,FL,62.0,M,Shaking and then became unresponsive,Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,OTH,ASPIRIN ASPIRIN EC 325 MG TABLET TAKE 1 TABLET BY MOUTH DAILY ATORVASTATIN 40 MG TABLET LIPITOR 40 MG TABLET TAKE 1 TABLET BY MOUTH IN THE EVENING AT 5PM OLANZAPINE 10 MG TABLET ZYPREXA 10 MG TABLET TAKE ONE-HALF (1/2) TABLET BY MOUTH TWICE,"Hyperlipidemia, Head Trauma, Hx of Seizures, Unspecified Psychosis, Depression, Mood Disorder, Substance Abuse","Hyperlipidemia, Psychosis, Depression",,None,"['Tremor', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,SYR 958327,FL,55.0,M,Headache and stoke,Not Reported,,Not Reported,Yes,,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Cerebrovascular accident', 'Headache']",2,PFIZER\BIONTECH,IM 958389,AR,82.0,F,"Stroke-like symptoms approximately 2-3 hours after receiving shot (aphasia), BP bottomed out, was transported by EMS and is currently on a ventilator in hospital. CT scan clear; MRI pending.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/18/2021,01/18/2021,0.0,PHM,"Brilinta, meloxicam, losartan, levothyroxine, pantoprazole, atorvastatin, allopurinol, paroxetine, diazepam",Unknown,"Heart disease, HTN, gout, hypercholestrolemia, hypothyroidism",,"PCN, Sulfa","['Aphasia', 'Blood pressure decreased', 'Cerebrovascular accident', 'Computerised tomogram normal', 'Laboratory test', 'Magnetic resonance imaging', 'Mechanical ventilation']",1,PFIZER\BIONTECH,IM 958398,AZ,74.0,M,"The next morning I felt chills, really cold, my arm never hurt at all. I was freezing. I had no energy. Very lethargic, with a blanket around me. Never had a fever. All of a sudden, around 2:30PM all dissipated, it was all gone and I was fine. A week later I called my PCP because the symptoms came back - the lethargy. He suggested me to go to the ER. I went and could barely write my name on the sign in sheet at the hospital. They did 5 COVID tests and 4 of them were negative. I was at the ER for 3 days and finally was admitted and stayed for 11 days. I was sent home with oxygen and my levels are finally getting back to 92/93. I can't walk at this time. I lost 17 lbs and if I try to walk my lungs shut down. ( I went to the ER n 01/07 and was discharged on the 17th - I was also at the ER the week before when they tested me and it kept coming back negative) My pulmonary MD",Not Reported,,Not Reported,Yes,11.0,Not Reported,N,12/26/2020,12/27/2020,1.0,PVT,"Symbicort, multivitamins, lodepine",no,COPD and HBP (last 6 months),,aspirin (highly allergic),"['Asthenia', 'Chills', 'Computerised tomogram', 'Dyspnoea exertional', 'Feeling cold', 'Gait inability', 'Lethargy', 'SARS-CoV-2 test', 'Weight decreased', 'X-ray']",1,PFIZER\BIONTECH,SYR 958416,MD,34.0,F,"Main concern was my baby's heartrate.. after receiving about 48 hours the baby heart rate was down.. the heart rate was down to 10.. I was sent home with close monitoring and after a few days the baby's heartrate finally was normal. I am told that I cannot get the second dose until after I give birth . My estimated date of delivery is February 8th 2021 I had flu like symptoms ,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/11/2021,2.0,PVT,Propranolol Vitamins,None,Ehlers Danlos syndrome,,None,"['Bradycardia foetal', 'Foetal monitoring', 'Foetal non-stress test', 'Influenza like illness', 'Ultrasound foetal']",1,MODERNA,IM 958470,LA,45.0,F,"Started with HA/fever/fatigue and body aches on date of vaccine on 1/5/21. Also had shakes,and had numbness loss of feeling to leg leg. Was admitted to Hospital for 5days. Had intermittnet seizure type episodes. Has had labs and imaging tests that have been neg Under the care of the A Neuro Group. MRI scheduled for 1/20/21. As of 1/20/21 feeling better but still weak.",Not Reported,,Not Reported,Yes,5.0,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,Ibprofen,Unkown,Unknown,,UNKNOWN,"['Asthenia', 'Electroencephalogram normal', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Imaging procedure', 'Laboratory test normal', 'Pain', 'Pyrexia', 'Seizure like phenomena', 'Tremor']",1,PFIZER\BIONTECH,IM 958487,ME,31.0,F,"Estimated due date: 07/16/2021 About 5 hours after the vaccine my arm started to hurt and I started having all body aches and chills, never had a fever. Very fatigued. At night I threw up and about 2AM I woke up drenched in sweat and I did not take my temperature. I woke up around 7AM and I had a migraine for about 2/3 hours - pounding headache. I took Tylenol, My body was really achy and my arm was like it was dead. General malaise, fatigue, it felt like I had a hangover, from my pounding headache. I threw up once again in the afternoon. Not sure if pregnancy related or the vaccine. Sunday morning I started feeling a little better. Saturday I felt horrible.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,prenatal vitamins. unison at night,no,no,,nickel,"['Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Hyperhidrosis', 'Malaise', 'Migraine', 'Pain', 'Pain in extremity', 'Vomiting']",2,PFIZER\BIONTECH,SYR 958501,VA,32.0,F,Client was pregnant at time of vaccination. She had consulted with 2 OBGYNS that are following her concerning if she should receive the covid vaccine. They both stated yes. She received her 1st covid vaccination to her left deltiod between 12pm - 1300 on 1/14/21. She did not experience any complications or feel any side effects immediately after vaccination. She was monitored by nursing staff for over 30 min to be prudent. On 1/16/21 the Sat following vaccination she began experiencing cramping in her stomach and began to bleed vaginally. She consulted w her OBGYN and was monitored. She miscarried on 1/19/21.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/16/2021,2.0,PUB,"8 weeks 5 days, estimated due date august 22, 2021, prenatel mvi qd",none,none,,NKA,"['Abdominal pain upper', 'Abortion spontaneous', 'Exposure during pregnancy', 'Pregnancy', 'Vaginal haemorrhage']",1,MODERNA,IM 958509,CA,46.0,F,"Fainting, dizziness and weakness, trembling, BP 168/129. HR 145",Not Reported,,Yes,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,OTH,None,None,None,,PCN,"['Asthenia', 'Blood test', 'Cardiovascular evaluation', 'Chest X-ray', 'Dizziness', 'Syncope', 'Tremor']",1,MODERNA,IM 958528,AZ,59.0,F,"upper respiratory infection, slowly getting worse and worse; Severe outbreak of genital herpes/herpesoutbreak/8-9 genital herpes; The reaction reported as it was not allergy. It was respiratory and central nervous system related; afraid of covid 19 vaccine because herpes goes wild; fatigue; Croupy pneumonia / Upper respiratory tract infection; recevied wrong vaccine / getting too high of a strain for my system; This spontaneous report was reciefed from a 59-year-old female patient via Pfizer. No information regarding the patient's medical history, drug reactions or allergies was provided. Her concomitant medications included echinacea. The patient's concurrent conditions included genital herps (reported as ""usually have one lesion when not under vaccination""). On 04-NOV-2014, the patient was vaccinated with the first dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) instead of pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) in the right arm (""rt arm"") for ""build up her immune system"" (prophylaxis)(exact dose, lot #, expiration date and route of administration were not reported). She stated ""feeling great day of shot"", ""worked at store that day with no problems"". The patent also reported ""getting too high of a strain for my system"", which ""could have been bad"" and ""what dose not kill you makes you stronger"". On 07-NOV-2014 (reported as 3 days after shot), she experienced croupy pneumonia (pneumonia) (also reported as the reaction respiratory related), which was described as ""croupy"" and ""damp"". On approximately 11-NOV-2014 (reported as 1 week after shot)(also reported as in November 2016), she had severe outbreak of genital herpes reported as 8-9 lesions, which was getting worse and worse. On an unspecified date the patient was hospitalized but no details were provided. It was reported that the patient was home treated (also reported as selfcare). She took echinacea and she was putting camphor, eucalyptus oil and menthol on his chest for a month. She was eating hot chicken soup and she often was going naturopathic. The patient did not go back to doctor. On an unspecified date in December 2014, the patient recovered from pneumonia (reported as it lasted one month). On an unspecified date, the patient had fatigue. On an unknown date, she also experienced upper respiratory infection (also reported as the reaction respiratory related), which was slowly getting worse and worse and on an unspecified date required hospitalization. It was additionally reported that the reaction, which the patient experienced was respiratory related but also central nervous system related (central nervous system disorder). The patient reported that it felt like she had the immune system ""panic attack"". Her nerves ""were worried about her immune system. The patient would like to know if new ""mRNA Covid-19 shot"" would give her 8-9 herpes lesions also? She was afraid of that as ""herpes goes wild"" (Fear of disease). The patient also reported that she was on no medications by doctor since November 2016 after than gynecologist gave her acyclovir for herpes outbreak as needed. She believed, she tried to get a refill from gynecologist for acyclovir ""to try to mange severe out break"" in November 2016. It was reported that on an unspecified date, the patient also recovered from the events of genital herpes and upper respiratory tract infection (reported as ""fine now""). The outcome of the events of fatigue, nervou system disroder and fear of disese was unknown. The causality assessment between the events and the suspect vaccine was not provided. Upon internal review, the event of pneumonia was determined to be medically significant.; Sender's Comments: US-PFIZER INC- 2020461144:",Not Reported,,Not Reported,Yes,,Not Reported,Y,11/04/2014,11/04/2014,0.0,UNK,echinacea (unspecified),,Medical History/Concurrent Conditions: Herpes genital,,,"['Condition aggravated', 'Fatigue', 'Genital herpes', 'Nervous system disorder', 'Pneumonia', 'Upper respiratory tract infection']",1,MERCK & CO. INC., 958533,AL,61.0,F,"Shingles/ a bad case of shingles; Injection site reaction described as a red, swollen, itchy rash; Injection site reaction described as red; Injection site reaction described as swollen; Information has been received from a pharmacist concerning a 61 year old female patient with drug reaction to betadyne, amitryptiline, hydrocodone, lorazepam (ATIVAN), clonazepam (KLONOPIN), mirtazapine (MSD), tetracycline and blue dye allergy who on 11-MAR-2011 was vaccinated with a single dose of zoster vaccine live (Oka/Merck), 0.65ml, subcutaneous. (Lot number not reported). The pharmacist reported that on 11-MAR-2011 the patient developed an injection site reaction described as a red, swollen, itchy rash in the evening following administration of the vaccine. The rash spread down the rest of the arm, down the hand and into the fingers during the next day, and it continued unabated to the present day. The pharmacist reported that the patient had a pre-planned hospital admission to an unspecified facility, for an unspecified surgical procedure, at an unspecified time during the week following the vaccination; she also reported that the hospital admission was not related to the vaccination. The patient sought medical attention by visiting unspecified physician. The pharmacist reported that patient's physician had sent off samples for unspecified lab work to determine if the patient had developed a case of shingles. Diphenhydramine hydrochloride (BENADRYL) and diphenhydramine hydrochloride (BENADRYL) cream were given as a treatment for the experience. At the time of the report, the patient had not recovered. Follow up information has been received from the pharmacist reporting that the 61 year old female patient was still having active break outs with swelling and itching. Her physician (name unspecified) confirmed that she had shingles by doing an unspecified test (previously reported). At the time of the report, the patient had not recovered. Follow up information has been received from the doctor of pharmacy reporting that the white 61 year old female patient with drug allergy to acetaminophen (+) propoxyphene napsylate (DARVOCET), amitriptyline, clonazepam (KLONOPIN), hydrocodone, blue dye, lorazepam (ATIVAN), mirtazapine (REMERON), povidone-iodine (BETADINE) and tetracycline, who on 11-MAR-2011 was vaccinated in her right arm, with the first dose of zoster vaccine live (Oka/Merck) (Lot number 669533/1383Z) at 18:30 p.m in a pharmacy with private funds. On 11-MAR-2011 at 19:00 the patient experienced swelling/redness at injection site. It was reported that later, the patient experienced swelling, redness and itching on entire arm lasted over a month with continued side effects-confirmed active shingles. At the time of the report, the patient had not recovered from active shingles. Follow-up information has been received on 15-JAN-2021 from a lawyer, regarding a case in litigation and refers to a 61-year-old female patient. On or around 11-MAR-2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the vaccine, she suffered a bad case of the shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the product. She also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered to be not recovered. The event was considered to be disabling.",Not Reported,,Not Reported,Not Reported,,Yes,N,03/11/2011,03/11/2011,0.0,PHM,,"Drug hypersensitivity (Medical History Comment: Betadyne, Amitryptiltine, Hydrocone, ATIVAN, KLONOPIN, REMERON, TETRACYCLINE, DARVOCET Stop Date: Continuing); Hypersensitivity (Medical History Comment: Blue Dye Stop Date: Continuing); Routine health maintenance",,,,"['Emotional distress', 'Herpes zoster', 'Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Pain', 'Rash']",1,MERCK & CO. INC.,OT 958559,,,F,"stroke (cerebrovascular accident); Initial information was received on 07-Jan-2021 regarding an unsolicited valid serious case from a consumer/non-health care professional. This case involves a female patient (age unspecified) who had a stroke (cerebrovascular accident), after she received INFLUENZA VACCINE. Medical history, concomitant medications, past vaccinations and family history were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed serious stroke (cerebrovascular accident) in less than a month following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. It is unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. It was not reported if the patient received a corrective treatment. At the time of report, the outcome of event was unknown. The information on batch number was requested; Sender's Comments: This case concerns a female patient (age unspecified) who experienced cerebrovascular accident in less than a month after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. Information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Cerebrovascular accident'],UNK,UNKNOWN MANUFACTURER,OT 958565,FL,71.0,M,"Clients wife reported on 1/18/2021, that her husband died unexpectedly the day after receiving the COVID 19 vaccine. I called and spoke with her. She stated that the client had started experienced some tightness in his chest the evening of 1/11/2021. She stated that it was normal for him to have the tightness in his chest if he got stressed. She stated that she found him on the garage floor on 1/12/2021 at 2120. He was taken by ambulance to the hospital. She stated that the hospital told her that his COPD had caused him to go into arrythmia.",Yes,01/12/2021,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,PUB,"Albuterol nebulizer, Saline nebulizer, Metoprolol, Vespi, Albuterol Inhaler, antibiotic 2-3 times per week",lung infection treated with antibiotics a couple of weeks ago,"Hypertension, COPD",,None Known,"['Arrhythmia', 'Chest discomfort', 'Death']",1,MODERNA,IM 958654,,39.0,F,Patient received Vaccine and during observation period began starring forward and not responding to staff. Patient was taken to the emergency room and evaluated and noted to have a flat affect and general weakness. Patient did not loos consciousness or have any signs of distress. Was admitted to the hospital and noted that she had been in out of country for a week (possibly had cosmetic surgery),Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,Valium Neurontin Hiprex Allegra Wellbutrin urecholine Celexa Flomax,UTI Major Depression,UTI Major Depression,,NKDA,"['Asthenia', 'Flat affect', 'Foreign travel', 'Haematocrit decreased', 'Platelet count decreased', 'Staring', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 958698,WA,27.0,F,"Around 10pm on Tuesday I started to have severe neck pain, headache, fatigue. I ended up going to the emergency room after my shift but due to the physicians recommendations I deferred the lumbar puncture while there. Later Thursday night, the neck pain continued, and I started having fevers with a max of 102.1 so I returned to the ER the following day for the lumbar puncture. I was admitted to the hospital for aseptic meningitis.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/03/2021,01/05/2021,2.0,PVT,"naproxen, advil",None.,Anxiety.,,Just animal dander,"['Angiogram cerebral', 'Antinuclear antibody', 'Arteriogram carotid', 'C-reactive protein', 'Computerised tomogram head', 'Computerised tomogram neck', 'Fatigue', 'Full blood count', 'Headache', 'Lumbar puncture abnormal', 'Magnetic resonance imaging', 'Meningitis aseptic', 'Metabolic function test', 'Neck pain', 'Pyrexia', 'Venogram']",1,MODERNA,IM 958745,CO,73.0,M,"Resident was noted to have increase weakness on 1/15/2021. Resident was warm to touch with low grade fever of 99.3 F. Resident was up propelling self in w/c on 1/16/2021 he was pleasant, accepted medications and ate lunch. He was found slumped over in his w/c not responding and vital signs absent.",Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/14/2021,2.0,SEN,"Divalproex Sodium Tab DR 250mg and 500mg, Lexapro 20mg, Quetiapine Fumarate 200mg tab, Senna 8.6 mg, Latanoprost drops,",Hx of TBI and schizophrenia with worsening behaviors over the past few months including refusing care including meals and medications and striking out with care. Resident had a fall on 1/14/2021. Resident received treatment for a UTI with Keflex for 7 days starting 12/6/2020.,"Traumatic Brain Injury, Shizophrenia, hydrocephalus, hemiplegia following cerebrovascular disease affecting right side, aphasia, reduced mobility with use of w/c, repeated falls, dysphagia, major depression, thrombocytopenia, gluacoma, epilepsy.",,No Known Allergies,"['Asthenia', 'Fall', 'Pulse absent', 'Pyrexia', 'Skin warm', 'Unresponsive to stimuli']",1,MODERNA,IM 958755,CA,40.0,F,"Pt was 18 weeks pregnant at the time of the vaccine. Second pregnancy. Pt is a physician. Pregnancy was entirely normal up to that time. On 1/18/2021, she began to have heavy vaginal bleeding probably due to a placental abruption and subsequently delivered at 18 weeks. Baby was stillborn. Ultrasound done 1/15/2021 normal. Lethal event for the fetus. The patient did well.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/12/2021,01/18/2021,6.0,UNK,prenatal vitamins,none,none,,none,"['Exposure during pregnancy', 'Foetal death', 'Premature delivery', 'Premature separation of placenta', 'Stillbirth', 'Ultrasound antenatal screen normal', 'Vaginal haemorrhage']",1,PFIZER\BIONTECH,IM 958838,PR,36.0,F,"sinus arrhythmia; Night sweats; Heart rate low; Dyskinesia; This is a spontaneous report from a contactable nurse (patient). This 36-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at single dose in the left arm on 07Jan2021 10:00 for covid-19 immunisation. Medical history included hypotension, rheumatoid arthritis, asthma. Concomitant medication included clonazepam, methylprednisolone. On 07Jan2021 21:00, the patient experienced sinus arrhythmia, night sweats, heart rate low, dyskinesia, all with outcome of recovered with sequelae. Therapeutic measures were taken as a result of the events included Inderal 10mg. The events were assessed as congenital anomaly. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,UNK,CLONAZEPAN;,,Medical History/Concurrent Conditions: Asthma; Hypotension; Rheumatoid arthritis,,,"['Dyskinesia', 'Heart rate decreased', 'Night sweats', 'Sinus arrhythmia']",1,PFIZER\BIONTECH,OT 958840,CA,28.0,M,"postural dizziness; dyspnea; paresthesia; This is a spontaneous report from a contactable Physician. This Physician reported for a 28-year-old male patient received 2nd dose of BNT162B2 Intramuscular on 10Jan2021 07:30 on Left arm for covid-19 immunization. Medical history and concomitant drug were not reported. No other-vaccine-in-four weeks. No other-medications-in-two weeks. Historical Vaccine was first dose of BNT162B2 on an unspecific date. Patient experienced Moderate reaction: postural dizziness, dyspnea, and paresthesia on 10Jan2021 09:00 AM that resolved with H1 and H2 antagonists and IV hydration. AE-resulted-in Emergency room/department or urgent care. Outcome of the event was recovered. No covid-prior-vaccination. No covid-tested-post-vaccination. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,,,,,,"['Dizziness postural', 'Dyspnoea', 'Paraesthesia']",2,PFIZER\BIONTECH,OT 958841,PA,65.0,F,"passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe headache; vomiting x 2; cold; experienced orthostatic hypotension; This is a spontaneous report from a contactable other HCP. A 65-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EK9231) vaccine , intramuscular in the left arm on 07Jan2021 11:00 at single dose for Covid-19 immunisation . Medical history included rubber sensitivity (Latex). The patient's concomitant medications were not reported. On 09Jan2021 12:00 the patient experienced orthostatic hypotension , passed out with outcome of recovered , dizzy with outcome of recovered , hit the ground with outcome of recovered. These events were considered serious because medically significant. On 09Jan2021 12:00 the patient also experienced the following non serious events: nausea with outcome of recovered , pain at injection site with outcome of recovered , fever with outcome of recovered , chills with outcome of recovered , tired with outcome of recovered , severe headache on with outcome of recovered , vomiting twice with outcome of recovered , cold with outcome of recovered. The reporter stated the patient attempted to get out of bed and she passed and hit the floor. Caller states she think she may have experienced orthostatic hypotension. Caller stated if she had stayed in bed she probably would not have fallen. Her husband found her laying in vomit The patient underwent lab tests and procedures which included body temperature: 99.6 fahrenheit on unknown date.; Sender's Comments: Based on a chronological temporal association a causal relationship between events orthostatic hypotension , passed out dizzy and falling down and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,OTH,,,Medical History/Concurrent Conditions: Latex allergy (known allergies: Latex),,,"['Chills', 'Dizziness', 'Fall', 'Fatigue', 'Feeling cold', 'Headache', 'Injection site pain', 'Loss of consciousness', 'Nausea', 'Orthostatic hypotension', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,OT 958842,AZ,,F,"Several back operations of stimulator in the back and in pain management; This is a spontaneous report from a contactable Consumer. This adult female Consumer(patient) reported that: An adult female patient received bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation. Medical history was none. No known allergies. The patient's concomitant medications were not reported. Patient was not pregnant a time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior to vaccination. The patient experienced several back operations of stimulator in the back and in pain management on an unspecified date, resulted in disability or permanent damage. Post the vaccination, the patient has not been tested for COVID-19. The outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,U,,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Disability', 'Injury', 'Pain management', 'Spinal nerve stimulator implantation', 'Spinal operation']",UNK,PFIZER\BIONTECH, 958843,WA,58.0,F,"I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive.; I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day; I woke up at midnight and felt extreme malaise; I was covered in sweat; vomited; I checked my temp and it was 99.7�F; sore; I think I had either a seizure or a vasovagal response.; This is a spontaneous report from a contactable nurse (patient). This 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular at single dose in the left arm on 09Jan2021 06:00 for Covid-19 immunisation. Medical history included atrial fibrillation on unknown date (1 episode), allergic to Keflex. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular in the left arm on 22Dec2020 for Covid-19 immunisation. On 10Jan2021 01:00 AM, the patient experienced: I began to pass out and yelled for my husband, he said when he came in i was sitting on the toilet with my head back, eyes rolling back not responsive (loss of consciousness) (medically significant), I had my 2nd vaccine at work early sat the 9th and felt increasingly worse all day (feeling abnormal), Iwoke up at midnight and felt extreme malaise (malaise), I was covered in sweat (hyperhidrosis), vomited (vomiting), I checked my temp and it was 99.7�F (pyrexia), sore (pain), I think I had either a seizure or a vasovagal response (seizure). No treatment required. The outcome of the events was recovered. The events were described as follows: I am healthy RN with no active medical problems. I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day, I expected this so was not alarmed and went to bed around 10pm. I woke up at midnight and felt extreme malaise and went to the bathroom in case I might vomit, etc. and I tried to have a BM. I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive. He yelled at me for about 10 seconds and I came to, I was covered in sweat. I asked him to walk me back to the bedroom where I again passed out, fell to the floor and hit the bed, then was unresponsive again for about 10 seconds then came to again and vomited. After this I felt completely relieved of my malaise. I checked my temp and it was 99.7�F. After this I was sore but otherwise completely okay, the next day I had a temp of 99.5�F. Today I am back to normal. I think I had either a seizure or a vasovagal response. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination.; Sender's Comments: Based on the close temporal relationship, the association between the event ""began to pass out"" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Atrial fibrillation (1 episode),,,"['Eye movement disorder', 'Fall', 'Feeling abnormal', 'Hyperhidrosis', 'Loss of consciousness', 'Malaise', 'Pain', 'Posture abnormal', 'Pyrexia', 'Unresponsive to stimuli', 'Vomiting']",2,PFIZER\BIONTECH,OT 958844,MT,46.0,F,"suddenly lost mobility of left arm; Continue paresthesia and proprioreceptive deficits of left arm; Continue paresthesia and proprioreceptive deficits of left arm; This is a spontaneous report from a contactable nurse (patient). This 46-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK5730) intramuscular, in right arm, on 16Dec2020 at 14:00, for COVID-19 immunization. No other vaccine was given in 4 weeks. Medical history included hypothyroidism, migraine headaches, IBS and COVID-19 (on an unspecified date prior to vaccination). Past drug history included allergy to morphine. Concomitant medication included levothyroxine sodium (SYNTHROID). On 23Dec2020 at 09:30 the patient experienced suddenly lost mobility of left arm, continue paresthesia and proprioreceptive deficits of left arm. She was transported to the ER and was admitted to hospital for 2 days. CT of brain X3, MRI of brain X2, MRI of C-spine and Brachioplexus were performed with unknown results. The patient was not tested for COVID19 after vaccination. The events resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. No treatment was administered. The events had not yet resolved.; Sender's Comments: Based on the temporal relationship, the association between the events "" lost mobility of left arm, continue paresthesia and proprioceptive deficits of left arm"" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,2.0,Yes,N,12/16/2020,12/23/2020,7.0,WRK,SYNTHROID,,Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination); Hypothyroidism; Irritable bowel syndrome; Migraine headache,,,"['Computerised tomogram head', 'Computerised tomogram spine', 'Loss of proprioception', 'Magnetic resonance imaging', 'Magnetic resonance imaging brain', 'Mobility decreased', 'Paraesthesia']",1,PFIZER\BIONTECH,OT 958845,CA,59.0,M,"thrombocytopenia; This is a spontaneous report from a contactable other health professional (patient). A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 04Jan2021 13:30 at single dose for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient experienced thrombocytopenia on an unspecified date with outcome of unknown. It was reported he had thrombocytopenia but did not experience any side effects. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported thrombocytopenia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Thrombocytopenia'],1,PFIZER\BIONTECH, 958862,IL,55.0,F,"on 1/12 started body aches and chills, took Tylenol and felt better, Wednesday felt short beat and irregular and heart beat not regular. checked pulse and it was irregular, that night 9-9:30 I went to ER close to house and pulse and heart rate abnormal after 2 hours went home and advised to contact cardiologist, he said to come in Thursday and the irregular beats were off and on atrial flutter, on Friday I came home and went back to hospital and got the shot cardio version or ablation to revert the rhythm and because the rhythm was back and forth I was observed until released on 1/19/21. Surgery was in 2017 and never had problems and they stated heart was compromised and maybe this is your reaction to the vaccine.",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,01/11/2021,01/12/2021,1.0,PVT,"Medication warfarin blood thinner, panantoprazol, atenolol, aspirin 81mg","no other illnesses, just prostatic mytro valve 4 years ago but totally fine","none just the valve disease that was taken care, it was caught and replaced",,"sulfa drugs, vancomycin","['Anxiety', 'Atrial flutter', 'Blood test', 'Cardiac ablation', 'Cardioversion', 'Chills', 'Echocardiogram', 'Electrocardiogram', 'Electrocardiogram ambulatory', 'Extrasystoles', 'Heart rate decreased', 'Heart rate irregular', 'Pain']",2,PFIZER\BIONTECH,IM 958885,TX,48.0,F,"The patient was seen in my office on 1/19/21 with complaint of heavy vaginal bleeding. A CBC was obtained which revealed an H/H of 12.2/36.1 and a platelet count of 1 (not 1K, but 1 platelet!) and this was confirmed on smear review. She was immediately sent to the Hospital ED and repeat CBC confirmed the critically low platelet count. She is currently hospitalized and she has received platelet transfusions but her platelet count is still critically low. She is also receiving steroids and immunoglobulin and is under the care of MD (Heme/Onc)",Not Reported,,Yes,Yes,,Not Reported,N,01/03/2021,01/16/2021,13.0,PVT,Losartin,None,Hypertension Obesity,,None,"['Blood smear test abnormal', 'Haematocrit decreased', 'Haemoglobin decreased', 'Immunoglobulin therapy', 'Platelet count decreased', 'Platelet transfusion', 'Vaginal haemorrhage', 'White blood cell count normal']",1,MODERNA,IM 958913,MN,61.0,M,"Resident became lethargic, general weakness outside baseline, unable to walk, bumbled speech. Elevated HR and Temp of 105.2F",Not Reported,,Yes,Yes,4.0,Not Reported,Y,01/14/2021,01/15/2021,1.0,SEN,"Vitamin B1 1000MG PO DAILY, Vitamin D3 2000 UI PO Daily, Levothyroxine 50mcg PO Daily, Trazodone 50MG Po HS daily, Tamsulosin 0.4MG PO DAILY, Ramipril cap 2.5mg daily, Quetiapine 150mg Po twice a day, Melatonin 5mg Po at HS. Olanzapine 10m","UTI, was taking Cipro","Neoplasm of unspecified behavior of brain, unspecified dementia with behavioral disturbance. HTN, Hypothyroidism, Insomnia",,NKA,"['Alanine aminotransferase normal', 'Aspartate aminotransferase normal', 'Asthenia', 'Bilirubin conjugated', 'Blood albumin normal', 'Blood bilirubin normal', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine normal', 'Blood glucose increased', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea normal', 'Body temperature increased', 'Carbon dioxide normal', 'Gait inability', 'Heart rate increased', 'Lethargy', 'Mean cell volume normal', 'Platelet count normal', 'Protein total normal', 'Speech disorder', 'White blood cell count normal']",1,MODERNA,IM 958914,GA,87.0,F,Death on 1/15/2020,Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/15/2020,,SEN,"Melatonin, Sertraline, Omeprazole, Resperidone, Depakote ER, vitamin E, multi vit, ASA, Lasix, gabapentin, potassium, Imodium, Zofran, Buspar, benztropine.",,"Alzheimer's, disorganized schizophrenia, HTN, CKD stage 3, Athritis, legal blindness, Dementia, Major Depression Disorder, Parkinson's, GERD",,NKA,['Death'],1,PFIZER\BIONTECH,IM 958926,RI,56.0,F,Patient developed right facial numbness and facial droop on 1/7/21. She came to the TMH ED and was admitted. She was afebrile; neurologic exam was consistent with a peripheral facial palsy on the right.,Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/03/2021,01/07/2021,4.0,PVT,Amlodipine 5 mg daily ASA 324 mg daily Atorvastatin 80 mg daily,None,Hypertension,,NKDA,"['Facial paralysis', 'Hypoaesthesia', 'Magnetic resonance imaging abnormal', 'Meningioma', 'Neurological examination abnormal']",1,PFIZER\BIONTECH,IM 958935,NC,92.0,F,Sudden Death within 24 hours of vaccine,Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/20/2021,1.0,SEN,"Aspirin, Biotin, Levothyroxine, melatonin, Namenda, Zyprexa, Trazodone, B12, B6, Vit D, Xanax",,"Dementia, HTN, Hypothyroidism",,Penicillin,['Sudden death'],UNK,MODERNA,SYR 958971,FL,84.0,M,"Hemorrhagic Stroke, Right Basal Ganglion",Yes,01/14/2021,Not Reported,Yes,,Not Reported,N,01/13/2021,01/14/2021,1.0,PVT,Simvastatin,,Aortic Insuf Dyslipidemia h/o prostate CA,,NKDA,"['Basal ganglia stroke', 'Computerised tomogram', 'Haemorrhagic stroke']",1,MODERNA,IM 958997,MO,52.0,F,"12:00 noon my arm was super sore and swollen and I could barely raise it. By the evening on the 24th I was super tired. Christmas , the 25th,I was really fatigued. 26th, I was very fatigued and no energy - like I almost had the flu. 27th - the same - couldn't get out of bed. 28th - started getting a dry, hacky cough and then it went away. 29th - tried to go to work and I didn't feel good at all and I just wasn't feeling myself. Had brain fog. Went to work - things that I know that Know wasn't there because of brain fog. Felt really like flu symptoms that night. 30th - body aches; headache and eyes felt like pressure behind them. Sent me to COVID and it was positive - was out 2 weeks from work. Went to back to work last week - but I still had shortness of breath, brain fog and fatigue and cough on Moday the11th; super tired still and I kept pushing myself to try to work and by Friday, 15th, I was just done. Exhausted. 16th - still having fatigue and 17th I thought I felt better when I woke up but still had my shortness of breath, cough and brain fog. At 2:00 pm I started feeling dizzy and faint like. I ate and within 20-30 min after food started throwing up, pounding headache. Every time I started trying to drink I would throw up. Monday, 18th, I went to work and I noticed whenever I moved around I was dizzy and short of breath and I couldn't eat or I would throw up. So slept the rest of the day. About 4:pm on Monday I thought I was going to pass out. 02 level at 86. Heartrate - Palpitations at 130. It was bouncing. Hving chest pressure, dizzy, pounding heart - 02 86 and Heartrate145. ER at 5:00 pm at Medical Ctr. Nausea medicine: Phenergan and Zofran. Did IV to hydrate me as I was dehydrated. Gave me Pepsid. I was a direct admit. They kept giving me hydration and nausea med and med for headaches and cardio workup - cardio came back normal. Severe lung inflammation. Was in the hospital until evening of 19th.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/23/2020,12/24/2020,1.0,OTH,none,no,Cardiac - bypass X2 and a pacemaker Heredity hypolipidemia,,Tramadol - confusion; out of body experience,"['Asthenia', 'Blood test', 'COVID-19 pneumonia', 'Cardiovascular examination', 'Chest discomfort', 'Computerised tomogram thorax abnormal', 'Cough', 'Dehydration', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Fatigue', 'Feeling abnormal', 'Headache', 'Impaired work ability', 'Influenza like illness', 'Mobility decreased', 'Nausea', 'Ocular discomfort', 'Pain', 'Pain in extremity', 'Palpitations', 'Peripheral swelling', 'Pneumonitis', 'SARS-CoV-2 test positive', 'Vomiting']",1,MODERNA,IM 959001,IL,55.0,M,"Patient woke apx 0200 complaining of nausea to group home staff. Vitals were checked at that time and WNL. Patient went back to bed. When staff went to wake patient apx 0530, he was unresponsive and had no pulse. Chest compressions were started and EMS called.",Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/16/2021,1.0,PUB,triamcinolone (KENALOG) 0.1 % Ointment amLODIPine (NORVASC) 5 MG Tablet Take 5 mg by mouth. ondansetron (ZOFRAN-ODT) 4 MG TABLET DISPERSIBLE Take 1 Tab by mouth every 8 hours as needed for Nausea - 1st line. acetaminophe,Unknown,Asthma Developmental delay (Pediatric) Eczema HLD (hyperlipidemia) HTN (hypertension),,"Penicillin's, Chocolate, Lactase, Fish, Nuts, Strawberry","['Nausea', 'Pulse absent', 'Resuscitation', 'Unresponsive to stimuli']",UNK,MODERNA,IM 959017,VT,41.0,F,Patient got her 2nd dose of Pfizer covid vaccine on 1/8. On 1/11 she had intermittent chest pain that lasted a few days and started to notice small purpura rash on left breast. She didn't think much of it but noticed the same type of rash on her pant line and then right thigh. On 1/15 she called Occupational Health who advised her to go straight to the ED.,Not Reported,,Yes,Yes,2.0,Yes,Y,01/08/2021,01/15/2021,7.0,PVT,"melatonin 3mg daily, magnesium 500mg daily, gabapentin 300mg BID",none known.,lower extremity neuropathy,,meperidine = hives/dyspnea,"['Chest X-ray abnormal', 'Chest pain', 'Immune thrombocytopenia', 'Immunoglobulin therapy', 'Platelet count decreased', 'Pulmonary hilar enlargement', 'Purpura', 'Rash']",2,PFIZER\BIONTECH,IM 959079,CO,91.0,M,"On 1/9/2021 observed with elevated respirations of 38-42 per minute, BP manually 72/50. pulse is jumping rapidly between 110-16 bpm. oxygen sat 76% RA, resident refusing oxygen at first attempt, allowed oxygen to be placed, is now 84% on 4L. resident shaking head yes that he is hurting, and yes that he would take medication for pain. Dr. notified, branch block. Received order for morphine 2mg per hr as needed for elevated respirations and pain. Dr. also gave orders to D/C Tamsulosin and finasteride. Resident continue with decreased O2 sats and elevated respirations. Absence of vital signs on 1/10/21 at 826PM.",Yes,01/10/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/09/2021,3.0,SEN,"Ascorbic Acid 500mg, Cetirizine HCL 5mg, Escitalopram Oxalate 10mg, Finasteride 5mg, Metoprolol succinate ER 25mg, Tamsulosin 0.4mg, Teriparatide 20mcg injection, Vitamin D3 Tablet, voltaren Gel 1%, Eliquis 5mg, Pantoprazole Sodium 40mg, Ac","Residents condition was declining over the past several months and has been treated for depression and dementia. Resident refusing care including meals, medication and ADL care.","Atrial Fibrillation, obstructive uropathy, chronic kidney disease, asthma, bradycardia, major depression, dysphagia, Parkinson's disease, dependence on supplemental oxygen, osteoporosis, hyperlipidemia,",,No Known Allergies,"['Bundle branch block right', 'Electrocardiogram QRS complex abnormal', 'Heart rate increased', 'Pain', 'Respiratory rate increased', 'Sinus tachycardia', 'Supraventricular tachycardia', 'Vital functions abnormal']",1,PFIZER\BIONTECH, 959090,OR,31.0,F,"Jan 4, 2021 received shot at work in morning around 11:00 am- felt fine at work all day. Around 7:00 that night began to have back pain, fever reached up to 102 around 2:00 am and took Tylenol. Felt very weak, headache, difficulty walking and decreased balance. On Jan 5, 2021 still had back ache and headache. On Jan 6, 2021 I felt better and began to have abdominal pain after eating dinner. I assumed it may be because of eating more then I had in past few days and did not attribute to much but the pain gradually increased to a strange burning/pressure across my upper abdomen that night. Very nauseous and ran low grade fever (99.45). Next morning I had less diffuse pain and could localize it to right lower quadrant.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/04/2021,01/06/2021,2.0,PVT,"Zyrtec, probiotic, B12, Zinc",None,None,,Penicillin- causes itching,"['Abdominal discomfort', 'Abdominal pain', 'Abdominal pain lower', 'Asthenia', 'Back pain', 'Balance disorder', 'Blood test', 'Computerised tomogram', 'Gait disturbance', 'Headache', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 959115,FL,34.0,F,"Tinnitus started in right ear within hour after receiving first vaccination but resolved within a couple of day. Within 24 hours of receiving second vaccination had muffled hearing, Jan 3, 2021. Symptoms were ignored thinking they would resolve. When symptoms persisted and evaluated patient was noted to have a severe right sided low frequency hearing loss with poor word recognition score. Patient was started on high dose steroids with partial recovery of symptoms.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/02/2021,01/03/2021,1.0,PVT,None,None,None,,None,"['Audiogram', 'Deafness', 'Hypoacusis']",UNK,PFIZER\BIONTECH, 959125,KY,76.0,F,"Employee received vaccine on 12/29/2020, was diagnosed with COVID-19 on 1/12/2021, had ED visit, received the Bamlanivimab infusion, returned to the ED on 1/16/2021, was admitted with dehydration, currently remains inpatient receiving Remdesivir infusion.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,12/29/2020,12/29/2020,0.0,OTH,"zolpidem Qhs PRN, Valsartan-HCTZ po daily, Rosuvastatin po daily, Pioglitazone po daily, HCTZ po daily, glimepiride po bid, diclofenac sodium po bid, vitamin d3 50,000 units po 1 x week, atenolol 25mg po daily, amlodipine po daily",none reported,"diabetes, hyperlipidemia, HTN",,"latex, levofloxacin","['Blood creatinine increased', 'Blood glucose increased', 'Blood potassium decreased', 'Blood urea increased', 'COVID-19', 'Chest X-ray abnormal', 'Dehydration', 'Fibrin D dimer increased', 'Lung infiltration', 'White blood cell count increased']",1,MODERNA,IM 959144,,27.0,F,Idiopathic intracranial HTN - IIH,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/10/2021,01/11/2021,1.0,PVT,OCPs,none,none,,None,"['Idiopathic intracranial hypertension', 'Lumbar puncture', 'Magnetic resonance imaging brain']",UNK,PFIZER\BIONTECH, 959147,OH,84.0,F,Unknown as to any correlation with vaccine as this was a hospice patient that was already experiencing decline. Patient became Jaundice for approximately one week prior to expiring.,Yes,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/02/2021,5.0,SEN,,"Alzheimer's disease, Type 2 with chronic kidney disease,","copd, Depression,psychosis,atherosclerotic heart disease",,penicillin,"['Death', 'Jaundice']",1,PFIZER\BIONTECH,IM 959156,PA,39.0,F,"Around 12 hrs later, I started feeling general fatigue, chills, no fever and achy all over. Didn't sleep well. I didn't take any meds since I'm pregnant. Symptoms peaked around 26 hours after vaccine. I slept almost all day. A very deep sleep. I started to feel a little better gradually. At 36 hours, I was completely back to normal. I am currently 31 weeks. I was 29 when I received the vaccine. Even with everything I experienced, I would do it again.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/09/2021,1.0,WRK,Prenatal vitamins,,,,Almonds (getting tested currently),"['Exposure during pregnancy', 'Fatigue', 'Pain', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 959160,NJ,29.0,F,"Unrelenting headache, chills, nausea, body aches, fever of 101.3F. Onset 14 hours after vaccine. Fever 20 hours after. Relieved with Tylenol and Motrin, ice packs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,PVT,Lo loestrin Fe,None,None,,None,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 959167,AL,84.0,M,Patient received COVID 19 vaccine 01/14/2021. Patient died in his sleep 01/16/2021.,Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/16/2021,2.0,PUB,unknown,,Seizures were reported on vaccine form,,NKDA,['Death'],1,MODERNA,IM 959179,CO,79.0,M,"Patient received COVID-19 vaccination on 1/14/2021. On 1/17/2021, patient was transferred to Hospital s/p multiple cardiac arrests. Patient was hyperkalemic and in acute renal failure at time of transfer. Hyperkalemia was treated, but the patient suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021. Ultimately we suspect that the patients condition was a direct result of his underlying disease states, but wanted to make sure reporting was made available.",Yes,01/18/2021,Not Reported,Yes,1.0,Not Reported,N,01/14/2021,01/17/2021,3.0,UNK,"losartan 100 mg QD, metformin 1000 mg BID, simvastatin 40 mg QD, tamsulosin 0.4 mg QD",,"Type 2 DM, Diabetic neuropathy/nephropathy, CKD Stage 3, Hyperlipidemia, Hypertension",,None,"['Acute kidney injury', 'Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood albumin decreased', 'Blood bilirubin normal', 'Blood calcium decreased', 'Blood chloride decreased', 'Blood creatinine increased', 'Blood culture negative', 'Blood glucose increased', 'Blood lactic acid', 'Blood magnesium normal', 'Blood phosphorus increased', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea increased', 'Cardiac arrest', 'Culture urine negative', 'Death', 'Diastolic dysfunction', 'Echocardiogram abnormal', 'Ejection fraction decreased', 'Haematocrit decreased', 'Haemoglobin decreased', 'Hyperkalaemia', 'Left ventricular dysfunction', 'Left ventricular hypertrophy', 'Platelet count normal', 'Pulseless electrical activity', 'SARS-CoV-2 test negative', 'Troponin increased', 'Ventricular fibrillation', 'Ventricular hypokinesia', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 959212,NJ,46.0,F,"Thursday 1/6/21 body aches, fever, chills Fri, Sat, Sun- Vomiting and diarrhea. Low blood pressure (average 70/40 Went to ER Sunday for hydration and low BP Wednesday 1/20/21 diarrhea x 25 episodes while at work, Sent home at 3:30pm. Body aches, chills, sever abdominal pain.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,Crestor 40mg daily Levothroxine 125mcg daily dexiliant 60mg daily Zetia 10mg daily Coreg 0.3125 daily homolog insulin through insulin pump Gabapentin 500mg TID Tramadol 50mg every 6 hrs pun tizidine 2mg every 8 hours pun,,type 1 diabetes gastroparesias hypothyroidism,,PCN Losartan Flagyl Reglan,"['Abdominal pain', 'Chills', 'Diarrhoea', 'Full blood count', 'Hypotension', 'Impaired work ability', 'Metabolic function test', 'Pain', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 959224,CO,29.0,F,"29-year-old female presented to the ED with complaints of nausea, vomiting, and fever. She received the COVID-19 vaccine yesterday. Initially, she felt well but around midnight she started having chills, fevers, and nausea/vomiting. She also complains of a headache with associated photophobia, with a headache described as a diffuse constant ache. She denies any abdominal pain or diarrhea. She denies any cough or cold symptoms. Prior to the onset of her symptoms around midnight, she felt fine.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,dextroamphetamine-amphetamine 30mg levothyroxine 25mcg lisinopril 20mg lorazapam 0.5mg,,"hypothyroidism, anxiety, ADHD, benign hypertension, diffuse spasm of the esophagus, GERD, tachycardia",,NKDA,"['Alanine aminotransferase increased', 'Albumin globulin ratio', 'Anion gap normal', 'Aspartate aminotransferase normal', 'Bacterial test positive', 'Basophil count decreased', 'Basophil percentage decreased', 'Bilirubin urine', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bilirubin normal', 'Blood calcium decreased', 'Blood chloride normal', 'Blood creatinine increased', 'Blood glucose normal', 'Blood osmolarity decreased', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea decreased', 'Blood urea nitrogen/creatinine ratio', 'Blood urine present', 'Carbon dioxide decreased', 'Chills', 'Chromaturia', 'Crystal urine absent', 'Eosinophil count decreased', 'Eosinophil percentage decreased', 'Glomerular filtration rate decreased', 'Glucose urine absent', 'Haematocrit normal', 'Haemoglobin normal', 'Headache', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Lymphocyte count normal', 'Lymphocyte percentage decreased', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Mean platelet volume normal', 'Monocyte count normal', 'Monocyte percentage', 'Nausea', 'Neutrophil count increased', 'Neutrophil percentage increased', 'Nitrite urine absent', 'Photophobia', 'Platelet count normal', 'Protein total normal', 'Protein urine absent', 'Pyrexia', 'Red blood cell count normal', 'Red blood cells urine positive', 'Red cell distribution width normal', 'Specific gravity urine normal', 'Urinary casts absent', 'Urinary sediment present', 'Urine analysis abnormal', 'Urine ketone body absent', 'Urobilinogen urine', 'Vomiting', 'White blood cell count increased', 'White blood cells urine negative', 'pH urine normal']",1,MODERNA,IM 959237,WA,,F,"My daughter was given 2 vaccines in her first 24 hours of life. We were released from the hospital at hour 28 of life, and she died at home at hour 39, due to ""unknown causes"" which they later diagnosed as SUIDS.",Yes,02/07/2019,Not Reported,Not Reported,,Not Reported,N,02/05/2019,02/07/2019,2.0,PVT,,,,,,"['Blood calcium normal', 'Death', 'Sudden infant death syndrome']",1,GLAXOSMITHKLINE BIOLOGICALS,SYR 959272,KS,85.0,M,"Patient died 4 days after immunization. Probably unrelated to immunization, as patient has been in poor health and was receiving hospice services. I have no details related to his illness or symptoms. Daughter is the HIPAA/emergency contact and will have all the information needed.",Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/15/2021,3.0,PVT,unknown,"uncertain illness, however, patient was on Hospice.","uncertain illness, however, patient was on Hospice. We are not his primary care providers, just provided the vaccine.",,none,['Death'],1,MODERNA,IM 959293,MD,68.0,F,"Sudden Sensorineural Hearing Loss in left ear. Symptoms began Friday evening Jan. 8, 2021. Sounded like muffled sound in my ear, water running, ringing. Then on Saturday Jan.9, 2021 my left ear felt like it had to pop and I felt my hearing was impaired. By Sunday evening Jan. 10, 2021, I could barely hear out of my left ear. I called MD immediately Monday morning, Jan. 11, 2021 and was seen that afternoon. I was examined and had a hearing test. I was diagnosed with SSHL and started treatment of a series of steroid injections directly into my eardrum to save my hearing immediately. I have had 2 injections and hearing test since then. The doctors feel this was a side effect of the COVID vaccine due to my compromised immune system, but not an allergic reaction, but a side effect. I had the same condition about 15 years ago from a virus.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/08/2021,01/08/2021,0.0,PUB,"Eplerenone, Metoprolol, Digestive Advantage Lactose Defense, D3,B12, Biotin, Potassium",None,"Microscopic colitis, Vestibular Disorder, Lupus, Fibromyalgia, V Tach, Hiatal Hernia",Influenza vaccine- Anaphylaxis,"Severe allergy to milk and all dairy , oysters, Lobster, Shrimp, Caffeine, MSG Environmental- Severe to Lavender and lavender family. Eucalyptus, spearmint and fresh cut evergreen trees Medication- Influenza shot, Compazine, Lidocaine, Doxycycline, Metronidazole, Flagyl, Amoxicillin, Ceftin, Macrobid, Ciprofloxacin, Augmentin, Bactrim, Amoxil, Zithromax, Biaxin, azithromycin, Ceclor, Tramadol","['Acoustic stimulation tests', 'Deafness neurosensory', 'Deafness unilateral', 'Ear discomfort', 'Hypoacusis', 'Sudden hearing loss', 'Tinnitus']",1,MODERNA,IM 959356,MN,89.0,F,Pt passed away the day after the vaccine was given.,Yes,01/14/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,SEN,N/A not a resident at the living center.,,,,,['Death'],1,MODERNA,IM 959396,MN,79.0,F,1/19/21: ER visit for evaluation 1/20/21: Hospital admit due to increased confusion and possible sepsis. Principle Problem listed: Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction; Acute encephalopathy SIRS likely due to COVID-19 vaccine but no current evidence of acute infection. Her acute encephalopathy is likely due to her SIRS response in the elderly and does not require acute intervention other than support.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/18/2021,01/19/2021,1.0,SEN,"Aripiprazone, Atorvastatin, Clonazepam, Trazodone, Loperamide, Pilocarpine, Clopidogrel, Culturelle, Desvenlafax, Lisinopril, Modafinil, Vitamin B-12, Caltrate, Metformin, Methylphenid, Vimpat",,"Cebral infarction, Other encephalopathy, Pain unspecified, Epilepsy, Dysphagia, Urinary incontinence, Chronic fatigue, Controlled type 2 diabetes, Essential hypertension, Cerebrovascular disease",,"Fentanyl, Rofecoxib","['Confusional state', 'Encephalopathy', 'Systemic inflammatory response syndrome', 'Vaccination complication']",UNK,MODERNA,IM 959400,IA,38.0,F,"12 hours after vaccination began experiencing fever, chills, body aches, slight head ache - lasted around 12 hours Had slight pain above eye prior to getting vaccination Saw PCP on 01/08/2021 due to eye pain - had CT scan for possible aneurysm, found 2 spots on brain, thought patient had shingles On 01/10/2021 shingles rash appeared",Not Reported,,Yes,Yes,6.0,Not Reported,N,01/06/2021,01/06/2021,0.0,PUB,None,None,Migraines,,None,"['Blood test', 'Cerebral disorder', 'Chills', 'Computerised tomogram head abnormal', 'Eye pain', 'Headache', 'Herpes zoster', 'Magnetic resonance imaging', 'Pain', 'Pyrexia', 'Rash']",1,MODERNA,IM 959401,OK,36.0,M,I was having episodes of dyspnea and non productive cough starting from 1/1/2021. On 1/13/2021 I experienced severe dyspnea and had loss of consciousness for 5 seconds and was found down. I was rushed to the hospital and diagnosed with multiple pulmonary embolus (about 9) which was treated with direct TPA via catheterization. I then recovered in the ICU and transitioned to oral anticoagulation and discharged home on 1/15/2021.,Not Reported,,Yes,Yes,3.0,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,Multivitamin,None,None,,None,"['Catheter placement', 'Chest X-ray', 'Computerised tomogram thorax abnormal', 'Cough', 'Dyspnoea', 'Echocardiogram normal', 'Electrocardiogram normal', 'Intensive care', 'Loss of consciousness', 'Pulmonary embolism', 'SARS-CoV-2 test negative', 'Ultrasound Doppler']",1,PFIZER\BIONTECH,IM 959417,,,U,"Anaphylaxis Allergic reaction COVID-19 vaccine: dizziness, vomiting and shortness of breath. Received vaccine and about 5/10 minutes later developed symptoms of chest tightness shortness of breath wheezing. Arrived to ED at 1156 and discharged at 1507. Given epi IM Solu-Medrol, Pepcid, Benadryl, albuterol.",Not Reported,,Yes,Not Reported,,Not Reported,,,,,UNK,,,,,,"['Anaphylactic reaction', 'Chest discomfort', 'Dizziness', 'Dyspnoea', 'Vomiting', 'Wheezing']",1,PFIZER\BIONTECH,IM 959549,MO,58.0,F,"1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21 started to have shortness of breath and made a doctor's appointment for 1/13/21. Seen by provider on 1/13/21 and was sent to ED and admitted to the hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery. Transferred to another acute care hospital for removal of thrombosis. Patient started on Eliqus and no intervention for removal of the thrombosis.",Not Reported,,Yes,Yes,5.0,Not Reported,N,01/02/2021,01/13/2021,11.0,PVT,Eliques; Cholecaleiferol; Ascorbic Acid; Calcium-Carbonate-Vitamin D; Coenzyme Q10; Ferrous Sulfate; Lisinopril; Magnesium Oxide; OxyCodone-Acetaminophen; Pantoprazole EC; Simvastatin; Vilazodone,Hip surgery 10/20,HTN; GERD; Back problems with left lower extremity numbness,,None,"['Acute myocardial infarction', 'Deep vein thrombosis', 'Dyspnoea', 'Erythema', 'Intensive care', 'Laboratory test', 'Pulmonary embolism', 'Tenderness']",UNK,PFIZER\BIONTECH,IM 959568,CO,70.0,F,"Patient received her first dose of the Moderna COVID-19 Vaccination on Saturday January 16th 2021 at approximately 12pm. She completed all necessary screening forms and was deemed to be at low risk for serious allergic reactions. She tolerated the vaccination well, and no complications or immediate adverse events occurred. She was observed for a full 15 mins per CDPHE/CDC guidelines and left the Clinic in stable condition after her observation period was complete. On the morning of Tuesday, January 19th, 2021, the patient was found unconscious and unresponsive by her husband. She was transferred by Ambulance to Hospital shortly thereafter. She was diagnosed with a brain bleed that was determined to be inoperable. She was transferred to other Hospital for higher level care. She was seen by neurosurgery and diagnosed with a ruptured aneurysm. She was treated in the ICU for 24 hours, at which point her team determined that the severity of her brain bleed would not respond to treatment. Supportive cares were withdrawn on Wednesday Jan 20th, and she passed away shortly thereafter.",Yes,01/20/2021,Not Reported,Yes,2.0,Not Reported,N,01/16/2021,01/19/2021,3.0,PVT,None disclosed,None disclosed,None disclosed,,None disclosed,"['Aneurysm ruptured', 'Cerebral haemorrhage', 'Death', 'Intensive care', 'Loss of consciousness', 'Unresponsive to stimuli']",1,MODERNA,IM 959591,CO,70.0,M,Resident has increase weakness and lethargy with abnormal labs. He was transferred to the ER. He was admitted to the hospital and treated for worsening AKI and hypotension.,Yes,01/17/2021,Not Reported,Yes,14.0,Not Reported,N,12/22/2020,12/31/2020,9.0,SEN,"Allopurinol 300mg, Atrovastatin 80mg, CaroSpir Suspension 25mg/5mL, Clopidogrel Bisulfate 75mg, Duloxetine HCL 30mg, Insulin- Lantus 14 units, Levothyroxine 137mcg, Lidocaine patch 5%, Potassium Chloride ER 20MEQ, Prilosec DR 40mg, Psylliu",He was treated for pneumonia and C-Diff at the beginning of December. He had abnormal blood work with elevated BUN and WBC on 12/31 and 1/3/21. Appetite was fluctuating and recently began increase medication for depression. Decrease responsiveness sent to ER on 1/4/2021.,"oxygen dependent, metabolic encephalopathy, atrial fibrillation, hypertension, diabetes, cardiac pacemaker, depression, congestive heart failure, obesity, hypothyroidism, sleep apnea, hyperlipidemia, cushing's disease.",,"Amoxicillin, Ceftriaxone, Lisinopril, Niacin, Pilglitazone, Rosiglitazone, Penicillins","['Acute kidney injury', 'Asthenia', 'Blood chloride decreased', 'Blood glucose normal', 'Blood sodium decreased', 'Blood urea increased', 'Full blood count', 'Hyporesponsive to stimuli', 'Hypotension', 'Lethargy', 'Metabolic function test', 'White blood cell count increased']",1,MODERNA,IM 959605,AZ,45.0,M,"Appendicitis, presenting as periumbilical tenderness at onset (26 hrs after vaccine admin) migrating to RLQ approx 20hrs later (46hrs after vaccine admin) accompanied by fever, chills, sweats, and nausea. Presented to ER that evening and CT confirmed appendicitis (52hrs after vaccine admin). Surgery following day laparoscopic appendectomy (69hrs after vaccine admin). Recovery and clinical improvement over next 8hrs (77hrs after vaccine admin). Discharged following day (96hrs after vaccine admin)",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/14/2021,01/15/2021,1.0,PUB,none,none,Mild intermittent asthma,,none,"['Abdominal tenderness', 'Appendicectomy', 'Appendicitis', 'Chills', 'Computerised tomogram abdomen abnormal', 'Full blood count', 'Hyperhidrosis', 'Laparoscopic surgery', 'Nausea', 'Pyrexia', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 959617,CA,75.0,M,"On 01/14/2021 patient developed fever and chills and had right leg pain similiar to previous episodes of leg infection, right lower extremity showed mild soft tissue swelling. Chest X-ray showed bilateral perihilar vascular congestion which was new since prior study. Patient's temperature was 40.12 C and blood pressure 193/85. Patient was admitted to Hospital at that time.",Not Reported,,Not Reported,Yes,6.0,Not Reported,U,01/11/2021,01/14/2021,3.0,OTH,,,,,,"['Blood test', 'Body temperature increased', 'Chest X-ray abnormal', 'Chills', 'Pain in extremity', 'Peripheral swelling', 'Pulmonary congestion', 'Pyrexia', 'X-ray limb']",1,MODERNA,IM 959620,OK,79.0,F,"Eleven hours after receiving COVID vaccine, client started experiencing stroke-like symptoms legs/arm weakness, couldn't speak, shortness of breath, and throat swelling. Hospital ruled out acute stroke but could not entirely exclude a cerebellar stroke due to her dizziness with vertigo and nystagmus (per hospital report). Client was in hospital 2.5 days, per hospitalist. note-all work up including MRI and tte were negative for acute findings- symptoms have resolved. Hospitalist noted symptoms may be worse following second shot. Spoke with client 1/19/21 and she reported feeling weak and tired only.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,"Atorvastatin 40MG PO DAILY, calcium 1200 MG PO BID, Vitamin D3 400 UNITS PO HS, Metoprolol SUCCINATE 37.5MG ORAL BID",none,"overactive bladder, anemia in the past, fibroid cystic disease",,"tamsulosin - unknown, ciprofloxacin PO and fluoroquinolones - throat closure, povidone - iodine -","['Asthenia', 'Cerebellar stroke', 'Computerised tomogram normal', 'Dizziness', 'Dyspnoea', 'Echocardiogram normal', 'Electrocardiogram normal', 'Fatigue', 'Full blood count normal', 'Laboratory test normal', 'Magnetic resonance imaging normal', 'Muscular weakness', 'Neurological symptom', 'Nystagmus', 'Pharyngeal swelling', 'Speech disorder', 'Vertigo', 'X-ray normal']",1,MODERNA,IM 959665,MD,89.0,F,3 days post = tremors; 4 days post= pneumonia; 6 days post= hospitalized,Not Reported,,Not Reported,Yes,,Not Reported,U,12/30/2020,12/30/2020,0.0,SEN,Unknown,"Diagnosis list is extensive. Please consult with Nursing Home for full list of conditions that patient has. Some include COPD, Diabetes, Heart Disease.","COPD, Diabetes, CHF",,"According to Nursing Home Face sheet Pt has allergies to Atorvastatin, Lisinopril and Valsartan","['Pneumonia', 'Tremor']",1,PFIZER\BIONTECH,IM 959710,MD,82.0,F,Patient unresponsive post vaccine. Taken to hospital. Please contact facility for full Report.,Not Reported,,Not Reported,Yes,,Not Reported,U,12/30/2020,12/30/2020,0.0,SEN,Unknown,None listed.,Pharygitis,,None Listed,['Unresponsive to stimuli'],1,PFIZER\BIONTECH,IM 959729,MD,82.0,M,Per Nursing Staff- patient died within 24 hours of receiving the vaccine. patient has hospice. Please contact director of nursing for more details.,Yes,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,SEN,unknown,"Tachycardia, Hypertension",Hytertension,,NKDA,['Death'],1,PFIZER\BIONTECH,IM 959746,ID,43.0,F,"Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.",Not Reported,,Yes,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,Zoloft; Migravent; Namenda; Full Strength aspirin; Prilosec - off brand; Bustar; Zyrtec - took it that morning only before shot as dr directed,no,Celiac disease; systemic lupus FLE; raynauld's; Shogren's; Kallmans syndrome; exercise induced asthma,,Nuts; dairy; adhesives; Celiac disease - no gluten,"['Anaphylactic reaction', 'Asthenia', 'Blood pressure increased', 'Dyspnoea', 'Impaired driving ability', 'Pruritus', 'Swelling face', 'Urticaria', 'Visual impairment']",1,PFIZER\BIONTECH,SYR 959747,MD,90.0,M,per staff at facility patient died 24 hours post vaccination. Please contact Director of Nursing for further details.,Yes,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,SEN,Unknown,Unknown,Ischemic Cardiomyopathy,,unknown - no,['Death'],1,PFIZER\BIONTECH,IM 959791,WV,50.0,F,"Swelling all over her body, ear popping all the time, hands and feet are numb, torso swollen and numb, face swollen and red. Taking steroids for four days. Went to hospital. Then went to other facility.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/08/2021,01/08/2021,0.0,WRK,"Levothyroxine, Crestor",no,no,,no,"['Blood test', 'Ear discomfort', 'Electrocardiogram', 'Erythema', 'Hypoaesthesia', 'Swelling', 'Swelling face']",1,MODERNA,IM 959857,PA,63.0,F,CVA the following day Patient had vaccine on 1/14/21 and was admitted to the hospital 1/15/21.,Not Reported,,Not Reported,Yes,,Not Reported,Y,01/14/2021,01/15/2021,1.0,PVT,unknown,No,Cancer 2016,,unknown,"['Atrial fibrillation', 'Cerebrovascular accident']",1,MODERNA,IM 959861,AZ,63.0,M,"C6-C7 epidural abscess, bacteremia with MSSA. IV antibiotics via PICC upon hospital discharge",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,12/22/2020,01/06/2021,15.0,PUB,,,,,"Naproxen, nuts","['Blood culture', 'Central venous catheterisation', 'Extradural abscess', 'Magnetic resonance imaging', 'Staphylococcal bacteraemia']",UNK,PFIZER\BIONTECH, 959928,,50.0,F,"Agitation, BlurredVision, Confusion, Anaphylaxis, UrticariaPruritus, Syncope, Pt experienced reaction three days PRIOR to first vaccine - event documentation only. Narrative: Pt has history of likely environmental allergies resulting in 4-5 mild reactions annually. Has seen allergist-immunologist in the community and has epi-pens, ranitidine and diphenhydramine. Had reaction three days PRIOR to first covid vaccine dose. She did NOT experience any untoward reaction to either dose of vaccine.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/20/2021,,,OTH,,,,,,['Unevaluable event'],2,MODERNA,IM 959929,,70.0,M,"Narrative: Patient seen in ED 1-17-21 with c/c of ""bloated with epigastric pain"". Patient with complicated medical history including stage 1B pancreatic cancer (was currently on chemotherapy mFOLFIRINOX), and a leadless permanent pacemaker implantation on 1-11-21 for long episodes of SR with complete heart block following symptoms of syncope (other cardiac history: CAD s/p CABG 2009, PAF, and HTN). Regarding ER visit for epigastric pain, nothing notable was found on workup and patient was to discharge home to rest. There were available doses of COVID-19 Vaccine following a vaccine clinic that same day, and patient was offered and agreed to a dose of vaccine. Patient was monitored for 15 minutes post vaccine with no notable issues. The following day, Monday 1-18-21, patient's caregiver called facility at 22:30 to report he had a fever of 102.8 degrees and that he had been ""feeling kind of bad all day"". Patient was advise to seek urgent medical care and reported back to ED on 1-19-21 at 00:55. Patient wasd admitted for SIRS (tachycardia and febrile) -- patient also reported diffuse myalgia. WBC WNL, CXR unremarkable for infection, UA neg for bacteria, LFTs WNL, blood cultures negative. Procalcitonin elevated at 17.8 -- suggesting inflammatory response. Patient initially reported feeling better on the morning of 1-19-21, but around 13:00 began rapidly declining (confusion, unable to walk) and started experiencing EKG changes (9 beats of SVT). Patient then coded and resuscitation was attempted for approximately 30 minutes. Patient did not survive the code. Coroner has been notified and family is considering autopsy at time of this report.",Yes,01/19/2021,Not Reported,Yes,,Not Reported,N,01/17/2021,01/18/2021,1.0,OTH,,,,,,"['Abdominal distension', 'Abdominal pain upper', 'Bacterial test negative', 'Blood culture negative', 'Cardio-respiratory arrest', 'Chest X-ray normal', 'Confusional state', 'Death', 'Electrocardiogram change', 'Feeling abnormal', 'Gait inability', 'General physical health deterioration', 'Liver function test normal', 'Myalgia', 'Procalcitonin increased', 'Pyrexia', 'Resuscitation', 'Supraventricular tachycardia', 'Systemic inflammatory response syndrome', 'Tachycardia', 'White blood cell count normal']",1,PFIZER\BIONTECH,IM 959933,OH,34.0,F,"Vaccine was administered very high, presumably in the joint space, rather than the deltoid. Patient experienced intense pain in the entire shoulder area for 24 hours following administration. After initial 24 hours, pain remained more localized in the joint itself. Pain is intensified when moving out of the neutral position.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/14/2021,01/14/2021,0.0,PHM,"Escitalopram, Tri-Lo-Marzia, Restasis, melatonin, Multivitamin, probiotic",None,None,,Penicillin,"['Arthralgia', 'Pain', 'Product administered at inappropriate site']",2,PFIZER\BIONTECH,SYR 959938,,58.0,M,"significant facial/lip angioedema first noted ~20 hours post vaccination, leading to intubation in ED due to concern for airway protection. extubated and discharged in 2 days",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/14/2021,01/15/2021,1.0,UNK,ibuprofen ~8 hours prior to symptoms,"COVID-19, symptomatic end of December, positive early January, and positive upon admission",,,none,"['Angioedema', 'Complement factor C4', 'Complement factor normal', 'Endotracheal intubation', 'SARS-CoV-2 test positive', 'Tryptase']",1,PFIZER\BIONTECH,IM 959960,IL,41.0,F,Admitted in Hospital for Anaphylaxis.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,100mg Topiramate,No.,No.,,Allergist reported possible positive reaction to shellfish test but I can consume shellfish without limit with no reaction.,['Anaphylactic reaction'],1,MODERNA,IM 959993,IN,69.0,F,Noticed small area of burning sensation at right side of wrist and the vein there was very enlarged and sticking out.,Not Reported,,Not Reported,Not Reported,,Yes,Y,01/17/2021,01/17/2021,0.0,UNK,,,,,Ampicillin,"['Burning sensation', 'Vasodilatation']",2,PFIZER\BIONTECH,SYR 959996,CA,37.0,F,"Began itching and wheezing approximately 5 minutes after the injection. Gave first epi dose. Throat started tightening, and nausea presented. Gave second epi 5 min after the first. Gave third epi 5 min after the second. EMS arrived, gave 4th epi in ambulance. ER treated with breathing treatment, IV steroids, IV Benadryl, IV Pepcid and IV zofran. Was observed for 6.5 hours.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,PUB,"Bupropion, tizanadine, ketorlac, Benadryl, multivitamin, epipen, albuterol",None,"Asthma, migraines",,"Peanuts, bees, dilaudid, vancomycin, reglan, contrast dye","['Nausea', 'Pruritus', 'Throat tightness', 'Wheezing']",1,MODERNA,IM 960001,LA,70.0,F,"Patient came to ED at 1600 with right upper lip swelling and finger swelling after getting covid vaccine earlier. Angioedema of lips, initial encounter; History of allergic reaction; Lip swelling; Vaccination side effects, initial encounter. Pt has history of rheumatoid arthritis. Was treated & discharged home on 1/12/21",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/10/2021,01/10/2021,0.0,PVT,,,Gastroesophageal reflux disease without esophagitis; History of allergic reaction; Lip swelling; Rheumatoid arthritis involving multiple sites with positive rheumatoid factor,,ACE INHIBITORS; AZITHROMYCIN; CIPROFLOXACIN; CODEINE; CYCLOBENZAPRINE; ERYTHROMYCIN; HYDROCODONE BITARTRATE; HYDROCODONE-ACETAMINOPHEN; SULFA (SULFONAMIDE ANTIBIOTICS); TRAMADOL,"['Angioedema', 'Lip swelling', 'Peripheral swelling']",1,PFIZER\BIONTECH, 960006,,81.0,M,Slurred speech started morning of 1/8 and patient went to ED after dialysis appointment. Admitted for TIA (transient ischemic attack). Discharged home on 1/10 with follow up appts with Neurology.,Not Reported,,Not Reported,Yes,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,,,Anemia of chronic disease; End stage renal disease;,,NO KNOWN DRUG ALLERGIES,"['Dialysis', 'Dysarthria', 'Transient ischaemic attack']",1,PFIZER\BIONTECH, 960013,,67.0,F,"Presented to ED 1/12 with primary complaint of Fatigue starting that AM. Being treated for Stage IV Sacral Decubitus Ulcer w/ possible osteomyelitis, Still admitted",Not Reported,,Not Reported,Yes,,Not Reported,U,01/10/2021,01/12/2021,2.0,PVT,,History of COVID-19 virus infection. First tested postive 12/2/20 and hospitalized 12/4-12/17. Tested positive again 1/12/21. past medical history end stage renal disease.,end stage renal disease.,,ADHESIVE TAPE-SILICONES; DULOXETINE; IODINATED CONTRAST MEDIA; POVIDONE-IODINE,"['Decubitus ulcer', 'Fatigue', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 960018,,73.0,M,Pt reported difficulty in swallowing and wife noticed left-sided facial droop morning of 1/10. Patient admitted for concerns of TIA. Symptoms resolved prior to hospitalization. Patient had MRI brain without contrast of the find evidence of acute infarct. Neurology recommended treatment patient has TIA and having dual anti-platelet therapy for 21 days followed by monotherapy of Plavix for stroke prevention. Patient was stable discharge to home 1/12/21,Not Reported,,Not Reported,Yes,,Not Reported,Y,01/10/2021,01/11/2021,1.0,PVT,,,,,PENICILLIN G POTASSIUM,"['Cerebral infarction', 'Dysphagia', 'Facial paralysis', 'Magnetic resonance imaging brain abnormal', 'Transient ischaemic attack']",1,PFIZER\BIONTECH, 960023,WI,50.0,M,Patient was receiving dialysis and had low grade fevers on the morning on 1/15/2021. Patient was sent to the hospital's emergency room and was found to have a temperature of 103. The patient also had mental status changes. It is unsure what caused the mental status changes and fevers.,Not Reported,,Not Reported,Yes,,Not Reported,Y,01/14/2021,01/15/2021,1.0,SEN,acetaminophen albuterol-ipatropium nebulizer amlodipine aspirin atorvastatin B complex-C-Folic acid benztropine biscodyl suppository carvedilol cholecalciferol fluoxetine hydralazine insulin lispro sliding scale lorazepam melatonin omega-3,Patient tested positive with COVID on 12/2020. Repeat COVID test on 1/5/21 was negative. Patient tested COVID positive 1/15/21.,"Diabetes, hypertension, hyperlipidemia, bipolar disorder, congestive heart failure, seizures, end stage renal disease on dialysis",,lisinopril ? angioedema,"['Computerised tomogram head abnormal', 'Dialysis', 'Electroencephalogram normal', 'Lumbar puncture normal', 'Magnetic resonance imaging brain normal', 'Mental status changes', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,MODERNA,IM 960025,,85.0,F,"Pt presented to ED with Left facial numbness and concern for stroke. Observed over night. MRI brain negative for acute process. Stable at baseline neuro status 1/10/21, discharged home.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/08/2021,01/09/2021,1.0,UNK,,,,,ATORVASTATIN; DEXLANSOPRAZOLE; LATEX; RABEPRAZOLE,"['Hypoaesthesia', 'Magnetic resonance imaging brain normal']",1,MODERNA, 960031,,71.0,M,"Pt Rec'd Covid vaccine and injection in Lt eye for macular degeneration. Monday 1/11 slurring speech/jumbled words since dinner, went to bed, wife states improved from last night but still difficult clearly communicating. Also reports difficulty writing. Came to ED and admitted for stroke evaluation. Stable for discharge home 1/13 with neurology follow up visits.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/10/2021,01/11/2021,1.0,UNK,,,macular degeneration,,NO KNOWN DRUG ALLERGIES,"['Dysarthria', 'Dysgraphia', 'Speech disorder']",1,PFIZER\BIONTECH, 960037,,71.0,M,Pt presented to ED 1/12 complaining of shortness of breath and nonproductive cough which onset approximately 8 days ago. Tested positive for COVID. Remains admitted for management of COVID.,Not Reported,,Not Reported,Yes,,Not Reported,N,01/10/2021,01/10/2021,0.0,UNK,,,,,CARISOPRODOL; WYGESIC,"['Cough', 'Dyspnoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 960038,,78.0,M,"Stated since Xmas he has not feeling well after a family gathering. His wife in hospital for Covid-19 pneumonia. He reports for about 1 week, his SOB worsen, not eating well at all for the past 3 days. Which prompt him to visit the ED. Admitted to Hopital for Dehydration; Dyspnea; Pneumonia due to COVID-19 virus; COVID+ 1/10/21; still admitted",Not Reported,,Not Reported,Yes,,Not Reported,N,01/06/2021,01/10/2021,4.0,UNK,,,,,"Bactrim [sulfamethoxazole-trimethoprim]; Latex, natural rubber; Ciprofloxacin; Nickel; Phenytoin sodium extended","['COVID-19 pneumonia', 'Decreased appetite', 'Dehydration', 'Dyspnoea', 'Malaise', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 960040,,81.0,M,Chest pain; LBBB (left bundle branch block); NSTEMI (non-ST elevated myocardial infarction); angioplasty & bypass done 1/11/21; discharged home 1/12/21 with referral to radiation oncology and f/u with interventional cardiology.,Not Reported,,Not Reported,Yes,,Not Reported,Y,01/08/2021,01/09/2021,1.0,UNK,,,,,no known allergies,"['Acute myocardial infarction', 'Angioplasty', 'Bundle branch block left', 'Chest pain', 'Vascular graft']",UNK,PFIZER\BIONTECH, 960044,,70.0,M,Patient with multiple co-morbidities including Gastroesophageal cancer presented to the ER after he spiked a fever of 100.8 F. Admitted with concern for drain displacement and fever on 1/7/21. The patient remained afebrile overnight. Imaging was evaluated by IR and the fluid collection was deemed to minimal to warrant intervention. Surgery evaluated the patient and concluded that no acute intervention was necessary. It is most likely that the patient's fever was a reaction to administration of the COVID-19 vaccine. The patient was deemed stable for discharge on 1/8 and sent home on 5-day course of antibiotics.,Not Reported,,Not Reported,Yes,,Not Reported,,01/05/2021,01/07/2021,2.0,UNK,,,Gastroesophageal cancer; Hypothyroidism due to acquired atrophy of thyroid; Normocytic anemia;,,IBUPROFEN,"['Imaging procedure', 'Pyrexia']",1,PFIZER\BIONTECH, 960047,,71.0,F,"Pt admitted to hospital on 1/4 with epigastric abd pain and tested positive for COVID. Discharged to recover at home on 1/6. Presented to different hospital 1/12 with progressive SOB. Remains admitted, being treated for Acute on chronic respiratory failure with hypoxia due to COVID-19 pneumonia.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/10/2021,01/12/2021,2.0,UNK,,,,,,"['Abdominal pain upper', 'Acute respiratory failure', 'COVID-19 pneumonia', 'Dyspnoea', 'Hypoxia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 960486,,94.0,F,admitted to hospital 1/11/2020 with Acute respiratory failure with hypoxemia; Iron deficiency; SOB (shortness of breath); Symptomatic anemia; still admitted,Not Reported,,Not Reported,Yes,,Not Reported,U,01/09/2021,01/11/2021,2.0,UNK,,,ANEMIA,,,"['Acute respiratory failure', 'Anaemia', 'Condition aggravated', 'Dyspnoea', 'Hypoxia', 'Iron deficiency']",UNK,PFIZER\BIONTECH, 960489,,99.0,F,presented to the ED with substernal chest pain with right to left side radiation and continuous waxing and waning right sided abdominal pain with back radiation consistent with previous episode of acute cholecystitis; still admitted,Not Reported,,Not Reported,Yes,,Not Reported,N,01/09/2021,01/11/2021,2.0,UNK,,,,,Azithromycin (swelling),"['Abdominal pain', 'Back pain', 'Chest pain', 'Pain']",UNK,PFIZER\BIONTECH, 960500,,80.0,M,"Hypoxia; Shortness of breath; Viral pneumonia; COVID-19; Weakness. COVID+ 1/7; Pt had Telephone encounter 1/1 reporting mild symptoms (fever, cough). Possibly infected prior to vaccination; still admitted",Not Reported,,Not Reported,Yes,,Not Reported,N,01/04/2021,01/09/2021,5.0,UNK,,,,,,"['Asthenia', 'COVID-19', 'Cough', 'Dyspnoea', 'Hypoxia', 'Pneumonia viral', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 960502,,80.0,M,"Re-admitted to hospital 1/10/21 for Pneumonia, physical deconditioning; still admitted",Not Reported,,Not Reported,Yes,,Not Reported,U,01/10/2021,01/10/2021,0.0,UNK,,previous COVID+ 12/10/20,,,ASPIRIN; DABIGATRAN ETEXILATE; IODINE; LISINOPRIL; NICKEL; PEANUT; PENICILLINS; RIVAROXABAN,"['Physical deconditioning', 'Pneumonia']",UNK,PFIZER\BIONTECH, 960512,CA,46.0,F,Shortness of breath panic attacks dizzy diarrhea pneumonia. Tingling in fingers and toes . Agitated muscle pain burning in the muscle of where the shot was located in my left side brace and chest,Not Reported,,Yes,Not Reported,,Yes,N,01/01/2021,01/14/2021,13.0,SCH,,High blood pressure Migraines obesity asthma social distancing disorder,Asthma arthritis in my spine high blood pressure prediabetic,,Milk,"['Agitation', 'Blood test', 'Diarrhoea', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Injection site reaction', 'Myalgia', 'Panic attack', 'Paraesthesia', 'Pneumonia', 'Pulmonary function test', 'X-ray']",1,MODERNA,SYR 962110,NH,49.0,F,"Approximately 5 hours after receiving my 2nd Pfizer Covid shot, I started to get diffuse abdominal pain & back aching. Seen in the ED 1/8/20 - Negative US, Normal labs - returned to ED 12 hours after D/C for worsening abdominal pain. 1/9/21 - CT showed Appendiciticitis",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/08/2021,01/08/2021,0.0,OTH,Vitamin D,None,None,,NKDA,"['Abdominal pain', 'Appendicectomy', 'Appendicitis', 'Appendicitis perforated', 'Back pain', 'Computerised tomogram abnormal', 'Laboratory test normal', 'Ultrasound scan normal']",2,PFIZER\BIONTECH,IM 960226,SC,,F,"Rare type of cancer; Blood titer had 'gone a little bit berserk' with a blood titer of '3000' / Caller reports most recent ''blood shingles titers"" 3060; Paralyzed/glued to floor; This spontaneous report was received from a nurse concerning to herself, who was a female patient of unknown age. No information regarding the patient's pertinent medical history, historical drugs, drug reactions, allergies, concurrent conditions or concomitant therapies was provided. On an unspecified date in 2007, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for prophylaxis (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not provided) on recommendation from two oncologists, one internist, and one allergist. On an unspecified date in 2007, within 8 days of receiving the mentioned vaccine, the patient became 'paralyzed/glued to floor' which had happened in 15 to 20 minutes intervals. At event time, blood titer was determined by healthcare professional (HCP) to be 4.3 (unspecified units). In Autumn 2020 (reported as ''last fall''), HCP drew blood at which time blood titer had 'gone a little bit berserk' with a blood titer of '3000' (unspecified units) (viral titre increased). On an unspecified date (reported as ''most recent''), a blood shingles titers' result of 3060 (unspecified units) was reported (per caller, normal would be 160 (unspecified units) (viral titre increased). On an unspecified date, patient experienced a rare type of cancer (neoplasm malignant). It was reported that, on an unknown date, patient was being treated with an unknown medication from an unknown manufacturer and patient was seeing a specialist for rare cancer treatment. It was also reported that, HCP had recommended patient receive unknown COVID-19 vaccine on unknown, future date. At the time of the report, the outcome of neoplasm malignant, viral titre increased and paralysis was unknown. The causal relationship between all the events and zoster vaccine live (ZOSTAVAX) was not reported. Upon internal review, neoplasm malignant and paralysis were considered serious due to medically significant criteria.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,09/01/2020,,UNK,,,,,,"['Neoplasm malignant', 'Paralysis', 'Viral titre increased']",UNK,MERCK & CO. INC., 960228,AR,,U,"shingles; neuropathy; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. In or around March 2011, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not provided) for its intended purpose, the prevention of shingles. Shortly after being vaccinated, the pt suffered shingles (herpes zoster) and neuropathy (neuropathy peripheral). As a direct and proximate result of the pt's use of the defective zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the company's product. The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of company's conduct, the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the claimed events was not recovered, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX). The reporter considered herpes zoster and neuropathy peripheral to be disabling events. Upon internal review, neuropathy peripheral was determined to be medically significant event.",Not Reported,,Not Reported,Not Reported,,Yes,N,03/01/2011,,,UNK,,,,,,"['Herpes zoster', 'Neuropathy peripheral']",UNK,MERCK & CO. INC.,OT 960304,NC,,F,"patient tested positive for COVID-19; patient tested positive for COVID-19; This is a spontaneous report from a contactable nurse (reporting for herself), via a Pfizer sponsored program. A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID-19. The patient underwent lab tests and procedures which included COVID-19: positive on an unspecified date. The outcome of the event was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 960309,,,F,"patient received the second dose of the vaccine on 06Jan2021 and tested positive for the COVID virus 09Jan2021; patient received the second dose of the vaccine on 06Jan2021 and tested positive for the COVID virus 09Jan2021; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age ((Age: 50; Unit: Unknown; as reported) received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine on 06Jan2021 and tested positive for the COVID virus 09Jan2021 (medically significant). The clinical course was reported as follows: The patient received the second dose of the vaccine on 06Jan2021 and tested positive for the COVID virus on 09Jan2021. The patient stated that she had signs and symptoms and had exposure to the COVID virus. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 09Jan2021. The clinical outcome of the events: drug ineffective and COVID-19 virus test positive, was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/09/2021,3.0,UNK,,,,,,"['Adverse event', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 960315,PA,,F,"received the Vaccine on 31Dec and on 04Jan was tested positive; received the Vaccine on 31Dec and on 04Jan was tested positive; Low-grade fever; slight loss of smell and taste; slight loss of smell and taste; This is a spontaneous report from a contactable Consumer. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received the Vaccine on 31Dec2020 and on 04Jan2021 was tested positive prior to having surgery. Minimal symptoms. Low-grade fever, slight loss of smell and taste. Outcome of events was recovering. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/04/2021,4.0,UNK,,,,,,"['Ageusia', 'Anosmia', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 960323,,,U,"Patient tested positive for COVID after first dose; Patient tested positive for COVID after first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number/expiration date unknown) via an unspecified route of administration on 22-Dec-2020 (19 days before 10-Jan-2021) at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient tested positive for COVID after first dose. Reporter would like to know how he should proceed for second dose. The outcome of the events was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 960367,NY,,F,"positive Covid test the day before second dose of vaccine; positive Covid test the day before second dose of vaccine; This is a spontaneous report from a Pfizer-sponsored program, by contactable physician reported for herself. This 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EK5730), intramuscular at single dose in the left deltoid on 22Dec2020 11:00 for Covid-19 immunisation. Medical history included was none. There were no concomitant medications. The patient experienced positive Covid test the day before second dose of vaccine on 11Jan2021 with outcome of not recovered. On an unspecified date, she can't smell or taste and has some shortness of breath on exertion with outcome of unknown. No further treatments given. Did not have any antibody testing recently and had history of negative antibodies prior to everything, receiving the first vaccine. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first vaccine on 22Dec2020 and went for Covid testing on Saturday, 09Jan2021. Found out results were positive on 11Jan2021. She was scheduled to have the second Covid vaccine on 12Jan2021. Patient then asks if there is a problem with her getting the second dose vaccine 10 days later than originally scheduled due to her results.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported ""positive Covid test the day before second dose of vaccine"".",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/11/2021,20.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Ageusia', 'Anosmia', 'Dyspnoea exertional', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 960368,CA,33.0,F,"lymphadenopathy at her bilateral axilla.; This is a spontaneous report from a contactable pharmacist (patient). This pharmacist reported similar events for 2 patients. This is the first report out of 2 patients. Only this case is serious, medically significant. A 33-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730, expiry date: 31Mar2021, NDC number: 59267-1000-1), intramuscular in the left deltoid on 21Dec2020 17:32 at 0.3ml single, for Covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced lymphadenopathy at her bilateral axilla and got worse on 07Jan2021. She reported that it was painful and swollen. The events was reported as serious medically significant. She wanted to know if she should have the 2nd dose of the vaccine. The outcome of the event was not recovered.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported lymphadenopathy cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : 2021025446 same reporter and drug/similar event/different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,01/07/2021,17.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Axillary pain', 'Lymphadenopathy', 'Oedema peripheral']",1,PFIZER\BIONTECH,OT 960369,SC,,F,"a mild anaphylactic reaction; tongue numbness/lips and tongue started to get numb; throat swelling; she was getting a migraine; she was flushed and her head got sick, and she got congested; she was flushed and her head got sick, and she got congested; she was flushed and her head got sick, and she got congested; This is a spontaneous report from a contactable other health professional (patient). This female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EK5730, Expiry Date Mar2021), via an unspecified route of administration at single dose in the left arm on 28Dec2020 for Covid-19 immunisation. Medical history included allergies to beestings. There were no concomitant medications. On an unspecified date, the patient experienced a mild anaphylactic reaction, tongue numbness, she was getting a migraine, throat swelling, she was flushed and her head got sick, and she got congested. No treatment required. The outcome of the events was recovered. The events were described as follows: Patient stated that she took the first dose of the Pfizer vaccine on 28Dec2020. She had an immediate reaction where she was thinking that she was getting a migraine; those symptoms included that the room got loud, she was flushed and her head got sick, and she got congested. She works at a hospital, and she got the vaccine at that hospital where she works. She waited the standard 15 minutes after the injection and then she walked back to her office. After 25 minutes had passed after getting the vaccine, her lips and tongue started to get numb and she could feel like her throat was starting to swell. Se did not take Benadryl, although in hindsight, she should have. She does have allergies to beestings, but the people administering the product did not know that. The primary care physician said that he did not think that she should take the second dose.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of mild anaphylactic reactions cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,,,UNK,,,Medical History/Concurrent Conditions: Allergy to arthropod sting,,,"['Anaphylactic reaction', 'Flushing', 'Hyperacusis', 'Hypoaesthesia oral', 'Immediate post-injection reaction', 'Malaise', 'Migraine', 'Pharyngeal swelling', 'Respiratory tract congestion']",1,PFIZER\BIONTECH, 960401,,,F,"after sleeping with her neck completely craned; paresthesia in the fingers of her left hand/right paresthesia on the sole of her foot; shock-like symptoms in both hands; Fever; Malaise; This is a spontaneous report from a contactable physician (patient). A female patient of unspecified age received BNT162B2 on 22Dec2020 first dose at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. She had the first vaccination on 22Dec2020. Caller states she had a fever, malaise for 2 days afterwards (24Dec2020). Around Day 4 (26Dec2020), she developed paresthesia in the fingers of her left hand and stimulation in her left hand, there was quite a lot of involvement with her hand. She also developed right paresthesia on the sole of her foot which lasted a couple of days. She states she has never experienced the hand thing completely, for such an extensive time. She has experienced stuff before, but milder. She has never had paresthesia in 2 different places. It seems she was experiencing shock-like symptoms in both hands, that lasted about a week. She did have a neurologic assessment, just as exam, not a testing. But, she confirms the testing was fine. She experienced re-occurring paresthesia in her left hand this morning, but it was after sleeping with her neck completely craned. Caller stated she doesn't know if its vaccine related. Also, her second vaccine is due this week and she doesn't want it be worse. The outcome of event shock-like symptoms in both hands was recovered on 02Jan2021. The outcome of event paresthesia in the fingers of her left hand/right paresthesia on the sole of her foot was recovered. The outcome of other events was unknown. Information about Lot/Batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported ""shock-like symptoms"" cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,UNK,,,,,,"['Malaise', 'Neurological examination normal', 'Paraesthesia', 'Posture abnormal', 'Pyrexia', 'Shock symptom']",1,PFIZER\BIONTECH, 960407,TX,69.0,F,"anterior cervical fusion; Headache; tested positive for COVID-19; tested positive for COVID-19; muscle aches; Loss of taste; Loss of smell; Nausea; sore arm; Tiredness; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EJ1686, intramuscular in right deltoid on 03Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included ongoing essential tremor started in her 50's. The patient's concomitant medications were not reported. The patient did not receive other vaccine within four weeks. On 03Jan2021 the patient experienced sore arm and tiredness. On 07Jan2021 the patient experienced anterior cervical fusion and was hospitalized from 07Jan2021 to 09Jan2021. On 08Jan2021 the patient experienced nausea. On 09Jan2021 the patient experienced muscle aches, loss of taste and loss of smell. On unknown date the patient experienced headache. The patient was tested positive to COVID-19 on 11Jan2021. The patient did not visit Physician Office or Emergency Room. Laboratory data included COVID-19 Rapid Test positive on 11Jan2021. The outcome of the events tested positive for COVID-19, and anterior cervical fusion was unknown. The outcome of the events sore arm, tiredness, nausea, muscle aches, headache was resolving. The outcome of the events loss of taste, loss of smell was not resolved.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and COVID-19 test positive on 11Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use. This 69-year-old female had medical history of ongoing essential tremor started in her 50's. The reported anterior cervical fusion was most likely due to concurrent disease, and unlikely causally related to the vaccine of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/03/2021,01/03/2021,0.0,UNK,,Essential tremor (Started in her 50's),,,,"['Ageusia', 'Anosmia', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain in extremity', 'SARS-CoV-2 test positive', 'Spinal fusion surgery']",1,PFIZER\BIONTECH,OT 960409,,,F,"flushing/ facial flushing; Hives; felt warm; short of breath/ audibly gasping for air; wheeze; throat tightening; throat got so swollen and itchy; throat got so swollen and itchy; could not swallow; This is a spontaneous report from a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. A non-contactable consumer reported that a 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history included food severe allergic reaction to influenza vaccine with eggs preservative. Concomitant medications were not reported. The patient previously took influenza vaccine and experienced severe allergic reaction to the eggs preservative. The patient received BNT162B2 vaccine and informed of prior history of severe allergic reaction to influenza vaccine with eggs preservative. She has previously received flu vaccine without egg without problem. Due to her prior history of severe allergic reaction/ anaphylaxis to another vaccine, in this case flu vaccine with eggs, it was noted to proceed with caution. She was told that the vaccination could be differed until more information became available but opted to proceed with receiving the vaccine and be observed for 30 minutes. The patient developed throat tightening approximately 20 minutes after vaccination. She received EpiPen within one minute of symptoms and was sent to the emergency room immediately in a wheel chair by Nursing staff. She was evaluated in the emergency department and was hemodynamically stable. She was given IV Benadryl and was stable throughout observation. The patient then reported that 40 minutes after injection, her throat and tongue started to feel weird and tight. The pharmacy at her work hospital gave her 25 mg Benadryl and 650mg Tylenol. At about 1 hour 45 minute after injection, her throat got so swollen and itchy to the point that she could not swallow. She went to the nearest emergency room hospital and they administered decadron and Pepcid orally, and Toradol intramuscularly. On an unspecified date, the patient also reported that 5 minutes after the vaccine administration, she developed flushing, hives, felt warm and eventually short of breath. She started to wheeze and was wheeled into the emergency room with complaint of ""cannot breathe, while holding throat and thrashing with facial flushness noted."" She took two Benadryl and had several epinephrine shots. She was discharged from the emergency room but later that day, she started to feel short of breath again. In the emergency department, she was audibly gasping for air, however had no wheezing, had a normal saturation and normal blood pressure. She had taken another dose of her EpiPen intramuscularly and diphenhydramine 50mg by mouth prior to coming. She was then admitted to the hospital for further observation. While on the floor, she started to feel short of breath again (about 9am on 18Dec2020), which required an ""RRT."" The patient received another dose of diphenhydramine IV, methylprednisolone 125mg IV and several doses of IM epinephrine and also required oxygen. She was than transferred to an ICU for further care. Outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.",Not Reported,,Yes,Yes,,Not Reported,U,01/09/2021,,,UNK,,,Medical History/Concurrent Conditions: Allergic reaction to excipient; Egg allergy,,,"['Dysphagia', 'Dyspnoea', 'Feeling hot', 'Flushing', 'Intensive care', 'Oropharyngeal discomfort', 'Paraesthesia oral', 'Pharyngeal swelling', 'Throat irritation', 'Throat tightness', 'Tongue discomfort', 'Urticaria', 'Wheezing']",UNK,PFIZER\BIONTECH, 960410,MI,36.0,F,"Severe Allergic response; This is a spontaneous report from a contactable nurse. A 36-year-old female nurse reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular at single dose into the left arm on 08Jan2021 at 12:00 PM administered at hospital for COVID-19 immunization. The patient had received the first dose of BNT162B2 intramuscular into left arm on 21Dec2020 at 02:30 PM into left arm. Concomitant drug included Lovenox. Medical history included factor five Leiden and allergy to shellfish. On 08Jan2021 at 01:00 PM the patient experienced a severe allergic response. The patient received two shots of epi pen, round the clock IV steroids, pepcid and Benadryl and was admitted into the hospital. Duration of hospitalization reported as 6. The adverse event resulted in Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reaction cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,6.0,Not Reported,U,01/08/2021,01/08/2021,0.0,PVT,LOVENOX [ENOXAPARIN SODIUM],,Medical History/Concurrent Conditions: Factor V Leiden mutation; Shellfish allergy,,,['Hypersensitivity'],2,PFIZER\BIONTECH,OT 960413,,46.0,F,"COVID test/ tested positive; COVID test/ tested positive; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (Lot Number: EL1284), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced COVID test/ tested positive on 29Dec2020, chills, body aches on 25Dec2020. She was supposed to get the second dose of the COVID Vaccine at the time of this report. She got the first dose on 23Dec2020 and after 2 days got chills and body aches. She took a COVID test swab on 29Dec2020. Then she tested positive on 31Dec2020. She was asymptomatic besides chills and body aches. She was in Isolation for 14 days and is done. She was wondering if she could take the second dose. Caller was a nursing assistant. The patient underwent lab tests and procedures which included COVID test swab: positive on 29Dec2020. The outcome of events was unknown.; Sender's Comments: The association between the event lack of effect (COVID test swab positive) with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/29/2020,6.0,UNK,,,,,,"['Chills', 'Pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 960419,OK,55.0,F,"Shortness of breath; Headache; Tinnitus; This is a spontaneous report from a contactable Physician. A 55-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, gastroesophageal reflux disease and asthma, all from an unknown date and unknown if ongoing. Known allergies reported: drug intolerances with nausea/vomiting to Opiates, TRULICITY, sulfa antibiotics. The patient's concomitant medications were not reported. The vaccine was administered at Hospital Facility. It was unknown If other vaccine were administered in four weeks. The patient did not experience COVID prior vaccination. The patient was tested for COVID post vaccination on 01Jan2021 and was negative. On 31Dec2020 within minutes of vaccination the patient experienced shortness of breath, headache and tinnitus. The events required visit to Physician Office and Emergency Room. The patient was admitted to hospital for 7 days. Therapeutic measures taken as a result of the events included epinephrine without benefit, prednisone course but tinnitus remained about 12 days since vaccination, corticosteroids, and H1 and H2 antagonists. The patient underwent lab tests and procedures which included COVID test post vaccination (Nasal Swab) on 01Jan2021 with negative result. The outcome of the events was recovered with sequelae. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events dyspnea, headache and tinnitus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,7.0,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Asthma; Drug intolerance (Drug intolerances with nausea/vomiting to Opiates); GERD; Hypertension; Nausea; Sulfonamide allergy; Type II diabetes mellitus; Vomiting,,,"['Dyspnoea', 'Headache', 'SARS-CoV-2 test negative', 'Tinnitus']",UNK,PFIZER\BIONTECH, 960426,OH,,U,"expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar death events for 8 patients. This report is for 1st of 8 patient. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information about Lot/Batch number is requested.; Sender's Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034597 same drug, reporter and event but different patient;US-PFIZER INC-2021034598 same drug, reporter and event but different patient;US-PFIZER INC-2021034599 same drug, reporter and event but different patient;US-PFIZER INC-2021034600 same drug, reporter and event but different patient;US-PFIZER INC-2021034601 same drug, reporter and event but different patient;US-PFIZER INC-2021034603 same drug, reporter and event but different patient;US-PFIZER INC-2021034596 same drug, reporter and event but different patient.; Reported Cause(s) of Death: expired before receiving the second dose",Yes,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,,,UNK,,,,,,['Death'],1,PFIZER\BIONTECH, 960427,OH,,U,"expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 2nd of 8 patients. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information about Lot/Batch number is requested.; Sender's Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: expired before receiving the second dose",Yes,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,,,UNK,,,,,,['Death'],1,PFIZER\BIONTECH, 960428,OH,,U,"expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 3rd of 8 patients. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information about Lot/Batch number is requested.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported death and the administration of COVID 19 vaccine, bnt162b2. However, more information on the patient's underlying medical condition, concomitant medications, patient's age group, clinical course and relevant lab tests would be helpful for the Company to make a more meaningful causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.; Reported Cause(s) of Death: expired before receiving the second dose",Yes,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,,,OTH,,,,,,['Death'],1,PFIZER\BIONTECH, 960429,OH,,U,"expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 4th of 8 patient. A patient of unspecified age and gender received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information about Lot/Batch number has been requested.; Sender's Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034595 same drug, reporter and event but different patient; Reported Cause(s) of Death: expired before receiving the second dose",Yes,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,,,OTH,,,,,,['Death'],1,PFIZER\BIONTECH, 960430,OH,,U,"7 residents expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 6th of 8 patients. A patient of unspecified age and gender received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: The event death is assessed as related to BNT162b2 vaccine and documented as such in the global safety database until sufficient information is available to allow an unrelated causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034595 same drug, reporter and event but different patient; Reported Cause(s) of Death: 7 residents expired before receiving the second dose",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,OTH,,,,,,['Death'],1,PFIZER\BIONTECH, 960431,OH,,U,"expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar death events for 8 patients. This report is for 7th of 8 patient. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information about Lot/Batch number is requested.; Sender's Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034595 same drug, reporter and event but different patient; Reported Cause(s) of Death: expired before receiving the second dose",Yes,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,,,OTH,,,,,,['Death'],1,PFIZER\BIONTECH, 960435,TX,39.0,F,"Internal brain bleeding 10 days after 1st dose covid vaccine; Brain damage; confused; suffering memory loss; This is a spontaneous report from a contactable Physician (patient). This 39-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 18Dec2020 14:30 at single dose (lot number: EJ1685) for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced internal brain bleeding and brain damage on 30Dec2020 07:30 after 1st dose covid vaccine. Brain surgery received on 29Dec2020. Events were still recovering. Patient was confused and suffering memory loss on 30Dec2020 07:30. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), disability or permanent damage. Days for hospitalization was 16. The patient received treatment for events as brain surgery due to internal brain bleeding. The patient was not pregnant. The patient had no COVID prior vaccination, no COVID tested post vaccination. Outcome of the events was recovering.; Sender's Comments: The reported internal brain bleeding and brain damage with confused and memory loss more likely represented intercurrent disease, and less likely causally related to 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,16.0,Yes,N,12/18/2020,12/30/2020,12.0,PVT,,,,,,"['Amnesia', 'Brain injury', 'Brain operation', 'Cerebral haemorrhage', 'Confusional state']",1,PFIZER\BIONTECH,OT 960436,NM,,M,"The patient had Hemolytic Anemia with symptoms starting within the first 24 hours of vaccine administration.; The first dose received on 18Dec2020 and the second dose received on 06Jan2021; The first dose received on 18Dec2020 and the second dose received on 06Jan2021; This is a spontaneous report from a contactable consumer. This consumer reported for a 37-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization on 06Jan2021. Relevant history and concomitant drugs were unknown. The patient previously received the first dose of BNT162B2 on 18Dec2020 for COVID-19 immunization. The patient did not receive other vaccine in four weeks of vaccination. No known allergies. The patient had Hemolytic Anemia with symptoms starting within the first 24 hours of vaccine administration on 06Jan2021. The patient had emergency room visit and physician office visit. No treatment was received (as reported). Outcome of event was unknown. The event was assessed as serious with serious criteria: Life-threatening, disability. Information about Batch/Lot number has been requested.",Not Reported,,Yes,Not Reported,,Yes,U,01/06/2021,01/06/2021,0.0,PVT,,,,,,['Haemolytic anaemia'],2,PFIZER\BIONTECH, 960438,OH,,M,"Patient suffered cardiac arrest, though most likely result of illicit substance use; patient had been feeling unwell with nausea and GI discomfort after receiving the vaccine 36 hours prior to; patient had been feeling unwell with nausea and GI discomfort after receiving the vaccine 36 hours prior to; patient had been feeling unwell with nausea and GI discomfort after receiving the vaccine 36 hours prior to; Patient suffered cardiac arrest, though most likely result of illicit substance use; This is a spontaneous report from a contactable physician. A 33-years-old male patient received bnt162b2 (BNT162B2, lot unknown), intramuscular on 14Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient suffered cardiac arrest 17Jan2021 11:15, though most likely result of illicit substance use since Jan2021, though patient had been feeling unwell with nausea and GI discomfort on 15Jan2021 23:15 after receiving the vaccine 36 hours prior to his arrest. The events were serious due to Life threatening illness (immediate risk of death from the event) and Disability or permanent damage. The patient had no COVID prior vaccination. COVID test type post vaccination=Nasal Swab on16Jan2021, test result was Negative. COVID test name post vaccination=Roche Cobas. The event outcome was not recovered. No treatment was received to events. No follow-up attempts are possible; information on lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events cardiac arrest, substance abuse, abdominal discomfort, malaise and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Yes,Not Reported,,Yes,N,01/14/2021,01/01/2021,,UNK,,,,,,"['Abdominal discomfort', 'Cardiac arrest', 'Malaise', 'Nausea', 'SARS-CoV-2 test negative', 'Substance use']",1,PFIZER\BIONTECH,OT 960439,MI,30.0,F,"Cardiac event; Paralysis; Fever; Numbness; Chest Pains; Dizziness; Weakness; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient started to receive first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 15Jan2021 14:15 at SINGLE DOSE for covid-19 immunisation. The patient was not pregnant. Medical history included tachycardia, Pre-ventricular contractions, allergies to Latex, covid-19 (reported as covid prior vaccination: Yes). Concomitant medication included metoprolol and multivitamin. No other vaccine received in four weeks. On 15Jan2021 14:30, the patient experienced chest pains, dizziness, weakness. On 15Jan2021 18:20, the patient experienced cardiac event, paralysis, fever, numbness, chest pains. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event)]. Treatment received for the events. No covid tested post vaccination. The outcome of the events was recovering. Information on batch/lot number was requested.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,WRK,,,Medical History/Concurrent Conditions: COVID-19; Latex allergy; Tachycardia; Ventricular contractions premature,,,"['Acute cardiac event', 'Asthenia', 'Chest pain', 'Dizziness', 'Hypoaesthesia', 'Paralysis', 'Pyrexia']",1,PFIZER\BIONTECH, 960448,TX,50.0,F,"positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, first dose on an unspecified date and second dose on 06Jan2021 (at the age of 50-years-old), at a single dose for COVID-19 immunization. Medical history included blood pressure high, high cholesterol, and sugar. Concomitant medications included rosuvastatin calcium (CRESTOR), amlodipine besilate, olmesartan medoxomil (AZOR), metformin (MANUFACTURER UNKNOWN) taken for sugar, and escitalopram oxalate (LEXAPRO). The patient experienced positive COVID-19 test on 09Jan2021. The patient underwent lab tests and procedures which included COVID-19 test: positive on 09Jan2021. The patient did not receive any treatment for the event. The clinical outcome of positive COVID-19 test was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/09/2021,,OTH,CRESTOR; AZOR [AMLODIPINE BESILATE;OLMESARTAN MEDOXOMIL]; ; LEXAPRO,,Medical History/Concurrent Conditions: Blood pressure high; Blood sugar abnormal; High cholesterol,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 960453,,,M,"Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID in Jan2021. Details were as follows: the patient received the vaccine in Dec2020 (reported as about 14 days or 15 days ago), and then he tested positive for COVID in Jan2021. Therapeutic measures were taken as a result of the event. On 09Jan2021, he went and got the monoclonic infusion. The outcome of tested positive for COVID was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,01/01/2021,31.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 960458,,,U,"Broken blood vessel in eye; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2) at single dose on 21Dec2020 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced broken blood vessel in eye on 27Dec2020. The outcome of events was unknown. The reporter considered there was not a reasonable possibility that the event broken blood vessel in eye was related to the vaccine. He was supposed to get second dose, but he did not know whether to get itor not. Information on the lot/ batch number has been requested.; Sender's Comments: There is not a reasonable possibility that event broken blood vessel in eye is related to BNT162B2. The event is most likely intercurrent medical condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/27/2020,6.0,UNK,,,,,,['Eye haemorrhage'],1,PFIZER\BIONTECH, 960460,IL,97.0,M,"died; tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program, Pfizer First Connect. A 97-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 at 97-years-old at a single dose for COVID-19 immunization; administered by the nursing home. Medical history included glaucoma from an unknown date and unknown if ongoing. Concomitant medications included: ""used a sav for skin tears"", and ""eye drops for glaucoma"" from an unknown date to an unknown date. On 07Jan2021, the patient experienced: tested positive for COVID (medically significant). The patient died (death, medically significant) on 17Jan2021. The clinical course was reported as follows: The reporter stated that in regard to the patient's height and weight: ""was probably getting down to about five foot eight. Shrinking."" The reporter stated that If she remembered correctly, they were trying to maintain the patient's weight 135 to 136 pounds. The reporter stated that her father was in a nursing home. The patient received his first dose of the COVID vaccine on 30Dec2020. The patient died on 17Jan2021. The reporter stated that she ""wanted Pfizer to know that the little old people in the nursing might not be strong enough for the vaccine."" The reporter stated that she was ""not calling to complaining."" The reporter stated that there was nothing wrong with her dad. He was elderly with no health issues. ""He was literally on no medications. The only reason he was in the nursing home was because he was afraid to walk."" The reporter stated that she received a call about giving the patient the vaccine and she said yes because she wanted him to have the vaccine. One week after the vaccine, the patient tested positive for COVID ""like all the other people"" (no further details provided). The reporter stated that her dad had no symptoms of COVID. The director of nursing said the patient was doing so well. The patient ate his lunch, he laid down for nap, and at 14:30 he was gone. The patient ""went peacefully in his sleep."" The reporter then again stated that the patient literally had nothing wrong with him. ""They were shocked. They fed him and he took a nap. He was sleeping, but it was eternally."" The reporter stated that, ""it might not have been the Pfizer vaccine, maybe his heart wore out."" In regard to an autopsy: the reporter stated that they would get it done if needed. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 07Jan2021. History of all previous immunization with the Pfizer vaccine considered as suspect: none. It was unknown if there were additional vaccines administered on the same date of the Pfizer suspect, but the reporter doubted it. There were no prior vaccinations within 4 weeks. There were no adverse events following the prior vaccinations. The clinical outcome of the event, died, was fatal. The clinical outcome of the event, tested positive for COVID, was unknown. The patient died on 17Jan2021 due to an unknown cause of death. An autopsy was not performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Reported Cause(s) of Death: died",Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,OTH,,,Medical History/Concurrent Conditions: Glaucoma,,,"['Death', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 960468,CA,58.0,F,"diagnosed with cancer after the first dose; patient received her first dose of Shingrix in August of 2019; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the cancer and incomplete course of vaccination were unknown. It was unknown if the reporter considered the cancer to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient receoved 1st dose of Shingrix and some point after vaccination diagnosed with cancer. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. This case was linked with case US2020202323, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020202323:same reporter",Not Reported,,Not Reported,Not Reported,,Not Reported,U,08/01/2019,,,UNK,,,,,,['Neoplasm malignant'],2,GLAXOSMITHKLINE BIOLOGICALS, 960535,CA,,U,"Asthma attack within 60 minutes, dry throat immediately after vaccination, stuffy nose, short of breath, abdominal pain and diarrhea headache within 12 hours, temp of 101.3, chills, weakness and fatigue for 24 hours. GI symptoms stopped after 4 days. Wheezing, SOB, fatigue, headache continue until now (2 weeks post vaccine). I've been put on prednisone, multiple inhalers, and had a cortisone injection. The lower I get on the prednisone, the weaker and more fatigued I feel. I've missed work for 2 weeks now. Cannot fulfill my job duties with this weakness, fatigue, lightheaded and dizziness. I am on disability for now.",Not Reported,,Not Reported,Not Reported,,Yes,N,,,,WRK,,,,"January 2012, age 33, MMR vaccine, 10 days of unbearable constant pain everywhere. Unable to function with ADL or work.",,"['Abdominal pain', 'Asthenia', 'Asthma', 'Body temperature increased', 'Chest X-ray normal', 'Chills', 'Diarrhoea', 'Dizziness', 'Dry throat', 'Dyspnoea', 'Echocardiogram normal', 'Electrocardiogram normal', 'Fatigue', 'Full blood count', 'Headache', 'Immediate post-injection reaction', 'Impaired work ability', 'Nasal congestion', 'SARS-CoV-2 antibody test positive', 'Urine analysis', 'Wheezing']",1,PFIZER\BIONTECH,IM 960552,,78.0,F,"At approximately 930am I arrived at Memory Care. I met with the director of the facility and she directed me to where my team would be setting up. My team consisted of (technician), (nurse) and I. As we were setting up, the director asked how she can help. I explained to her that we would need a designated area for patients to be monitored after vaccination for 15 minutes and maybe even longer . I also explained that we would need one of her staff monitoring while we vaccinate. She agreed, and proceeded to designate her staff and the cafeteria area, facing the vaccination station,the monitoring station. Throughout the day, nurse and I were both vaccinating,while the staff of the facility would monitor the vaccinated patients. I would also stop occasionally to mix the vaccine and check the temperature of the aero safe. At approximately 12:50pm, the director rushed in and stated that a patient is not responding, and that she had been vaccinated. At that point, I grabbed epipens and a thermometer and I also instructed nurse to grab an Epipen and come with me. We followed the director to pt's room. Once we got to the room, the patient was in bed and there were 4 staff members standing bedside and one of them turned and stated the patient has passed. At that point I asked the staff how long ago did the patient get the vaccine, they stated about 30 minutes ago. They also stated that the patient was a hospice patient and that the patient had declined, and was rapidly detiorating and had not eaten or drank anything all day . They also stated that the patient had been monitored for 15 minutes post vaccination. I then left the room and grabbed the patients COVID Vaccine intake consent form. I looked at the answered questionaire and all the responses were circled NO. Patient had a temp of 96.5 at the time of vaccination.The vaccine administration information for Immunizer Section was filled out by Nurse. I then proceeded to ask the director once again if there were staff that was monitoring her for 15 minutes, the director stated they had staff monitoring her. She also stated the Hospice nurse has to announce her death, so they waited for the Hospice Nurse to come. I then called Corporate and explained the situation. After speaking to corporate, I also asked nurse, if she remembered the patient. She stated that she did and at the time of the vaccination the patient was not alert, there were two staff members with the patient. She was non oriented and she kept closing her eyes. At that point, Nurse stated that she asked the two staff members with her if this is how she usually is and if its ok to vaccinate her. Both Staff members stated that it its ok,this is how she is. The Nurse then proceeded to vaccinate. At approximately 3:10pm, as I was leaving I spoke to the director, and one of her Staff members. Staff that the patient has actually not eaten/ or drank anything for the past several days, including today(01/18/21). Staff also stated that on Friday, Jan 15th,2021, they had informed the family that the patient was rapidly detiorating. Staff also stated that the family knowingly gave the consent to vaccinate her. She also stated that the hospice Nurse believes that the death was primarily caused by her detiorating state. She also stated that the hospice Nurse informed that the death was not due to the Vaccine. Per Lead Pharmacist at the clinic.",Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/18/2021,0.0,SEN,Unknown,Patient was a hospice patient who was not doing well for several days per nurse. Patient had not eaten or consumed liquids in a few days.,Patient was a hospice patient.,,No known Allergies,"['Death', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 960557,SD,20.0,F,"Extreme headache, fever of 102-103 degrees farenheight, dizziness, syncopal episode at work, transferred to ER, heart rate 160s-180s, hypertensive emergency blood pressures 160s/90s. Today 1/20/2021 approx 1700.",Not Reported,,Yes,Not Reported,,Yes,N,01/20/2021,01/21/2021,1.0,PVT,"Metoprolol, sertraline, omeprazole, nortriptyline. Been taking these medications for 4-6 years, no problems.",None,"Abdominal migraines, migraine headaches-active POTS-resolved/grew out of Depression",,Metoclopramide?tardive dyskinesia,"['Blood culture', 'Dizziness', 'Electrocardiogram', 'Full blood count', 'Headache', 'Hypertensive emergency', 'Metabolic function test', 'Pyrexia', 'SARS-CoV-2 test negative', 'Syncope', 'Urine analysis']",2,MODERNA,IM 960580,NV,71.0,M,Ventricular tachycardia resulting in cardiac arrest,Not Reported,,Yes,Not Reported,,Not Reported,U,01/20/2021,01/20/2021,0.0,UNK,,,"DM, CHF, CAD",,,"['Cardiac arrest', 'Ventricular tachycardia']",UNK,MODERNA, 960600,UT,57.0,M,"The patient received the second dose of the Moderna vaccine at the Health Department. The patient experienced a rapid onset of a dry mouth and throat, followed by a restricted airway and elevated blood pressure. The patient was given 2 x 25 mg pf Benadryl, however, due to rapid restriction of the airway .05 of epinephrine was administered by injection. The symptoms subsided slightly. A second injection of .05 mg was administered. The patient was observed and released with instructions to contact his primary care physician.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,PUB,"Metoprolol Tartrate 25mg, Losartan Potassium 25 mg",None,"High Blood Pressure, Hypokalemic Periodic Paralysis","Toradol, Euflexa","Toradol, Euflexa","['Blood pressure increased', 'Dry mouth', 'Dry throat', 'Obstructive airways disorder']",2,MODERNA,IM 960714,NY,50.0,F,"Pt received vaccine and developed HA with left hemianopsia, left upper ext and left lower ext weakness. Stroke Code activated at clinic where she works CT head neg TPA administered, transferred to ED for CTA and stroke care CTA neg MRI pending but clinically improved",Not Reported,,Yes,Yes,,Not Reported,U,01/20/2021,01/20/2021,0.0,PVT,synthroid,none,per neuro consult note hypothyroid on synthroid chronic left eye lid ptosis dural venous thrombosis 2010 cardiac arrest 2000 varices/ GI bleed hep B cirrhosis,,NKDA,"['Angiogram', 'Cerebrovascular accident', 'Computerised tomogram head normal', 'Headache', 'Hemianopia', 'Magnetic resonance imaging', 'Muscular weakness']",UNK,PFIZER\BIONTECH, 960752,LA,69.0,M,Extreme Fatigue,Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,SEN,Several .. I have a list,No,"Diabetic , High Blood Pressure",,No,['Fatigue'],UNK,MODERNA,SYR 960796,TN,60.0,M,"Loss of concentration; small shingles outbreak/ persistent painful blistering rash on top of his head in his hair, on his face and in his ear/ diagnosed as herpes zoster; ears started ""feeling funny""/ persistent painful blistering rash on top of his head in his hair, on his face and in his ear; The vaccine did not prevent shingles, but rather caused patient to contract a persistent strain of herpes zoster; persistent painful blistering rash on top of his head in his hair, on his face and in his ear/ diagnosed as postherpetic neuralgia; This spontaneous report was received from a patient's wife and pharmacist and refers to 60-year-old (also reported as 56-year-old, conflicting information) male patient. The patient's concurrent condition included unspecified heart disease. The patient had no drug reactions or allergies. The patient's medical history and concomitant medications were not reported. On 07-MAR-2015 (also reported as on Saturday), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) vial 19400 plaque-forming unit (PFU), lot # K016326, expiry date 24-DEC-2015 (dose, route of administration, application site were not reported) for the prevention of shingles/ vaccination/ to prevent shingles. On 08-MAR-2015 (reported as the day after getting zoster vaccine live (ZOSTAVAX), also reported as by Sunday afternoon), his ears started ""feeling funny"". On the same day, he also experienced headache and shooting pains accompanied by a burning sensation, all of which occurred on his face without rash and redness. The patient had shooting pains, tingling and numbness on the left side of his face and had. The pharmacist believed it was a small shingles outbreak. The patient's wife reported that he developed shingles in the left side of his face. The patient contacted pharmacist due to the event. It was reported that he went to his physician and was given an unspecified steroid shot and a dose of steroids in pills due to shingles. The patient stated that he felt that the vaccine gave him shingles. There was no treatment given for the events. The outcome of shingles was reported as not recovered. The outcome of remaining events was not reported. The patient considered the shingles to be related to zoster vaccine live (ZOSTAVAX). The relatedness between ears started ""feeling funny"" and zoster vaccine live (ZOSTAVAX) was not provided. Follow up information has been received on 18-OCT-2019 from a lawyer, regarding a case in litigation and refers to a male patient. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused patient to contract a persistent strain of herpes zoster accompanied by pain. On an unknown date (reported as shortly after receiving vaccine), the patient developed a persistent painful blistering rash on top of his head in his hair, on his face and in his ear. In response to these symptoms, he presented to a physician, where he was diagnosed with herpes zoster and postherpetic neuralgia and remained under their care. As a result, the patient had suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). Follow up information has been received on 18-JAN-2021 from a lawyer via a Plaintiff Fact Sheet, regarding a case in litigation and refers to a 60-year-old male patient (pt). The pt never smoked or used tobacco products. He was diagnosed with chickenpox in approximately 1964, at the age of approximately 9 or 10 years old. He was never vaccinated with chickenpox vaccine. On 07-MAR-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) in left arm, by a pharmacist at a pharmacy. The pt claimed to suffer following physical injuries caused by zoster vaccine live (ZOSTAVAX): shingles (herpes zoster) and postherpetic neuralgia (PHN). The pt suffered from pain which led to loss of concentration, loss of work. He had severe pain on the side of his face, head, neck and in his ear. The pt first became aware of the injuries as initially he noticed the pain at night of 07-MAR-2015, but the following day 08-MAR-2015 it got much worse. He first became aware of the injuries as within hours he began to experience pain in his hair, face and ear. It was painful to touch. The following day he broke out in bumps and sores in his hair, side of his face and ear. He was diagnosed with shingles and postherpetic neuralgia (PHN) by a physician in approximately March 2015. On an unknown date in March 2015, he was prescribed unspecified medication for nerve pain by a physician (could not recall name of medication). On an unknown date in March 2015, he communicated with a physician about whether the injuries were related to or caused by zoster vaccine live (ZOSTAVAX). He reported that he saw provider for shingles treatment and discussed injury. He stated that he did not know if any test to determine if the rash following vaccination with zoster vaccine live (ZOSTAVAX) was wild type or vaccine strain varicella zoster virus was ever performed by a healthcare provider. He was never told by any healthcare provider that he had vaccine strain varicella zoster virus. The pt claimed that zoster vaccine live (ZOSTAVAX) did not cause or aggravate any psychiatric/ psychological conditions other than pain, suffering and emotional distress, for which treatment was sought from a healthcare provider. The pt filed for social security due to retirement in 2019, which was granted. In the 7 years preceding his zoster vaccine live (ZOSTAVAX) vaccination to the present, the pt received inpatient or outpatient care from his primary care physician (PCP) (2005 to present). In the 7 years preceding zoster vaccine live (ZOSTAVAX) to the present, the pt required hospitalization or recurrent medical care and treatment or medication due to high cholesterol (2005 to present) and high blood pressure (2010 to present). In the 7 years preceding zoster vaccine live (ZOSTAVAX) to the present, the pt's prescription medications taken on a regular basis included: rosuvastatin for high cholesterol (2005 to present) and metoprolol for high blood pressure (2010 to present). The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). Follow up information has been received on 18-JAN-2021 from pharmacy records, regarding case in litigation. On 07-MAR-2015, the pt was dispensed zoster vaccine live (ZOSTAVAX) 19400 PFU injection, quantity 1. Upon internal review, the event of herpes zoster in his ear was considered to be medically significant. It has been determined that cases # US-009507513-1503USA005428 and US-009507513-1503USA012042 are a duplicate case of case # US-009507513-1503USA004588. Therefore cases # US-009507513-1503USA005428 and US-009507513-1503USA012042 are being deleted from our files and the cases are consolidated into case # US-009507513-1503USA004588.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2015,03/01/2015,,PHM,rosuvastatin; metoprolol,Blood pressure high (dates of care: 2010 to present); Cardiac disorder; Cholesterol high (dates of care: 2005 to present); Non-tobacco user; Routine health maintenance,Medical History/Concurrent Conditions: Chickenpox (at approximately 9-10 years of age),,,"['Blister', 'Burning sensation', 'Disturbance in attention', 'Ear pain', 'Headache', 'Herpes zoster', 'Hypoaesthesia', 'Neck pain', 'Pain', 'Pain of skin', 'Paraesthesia', 'Post herpetic neuralgia', 'Rash', 'Tenderness', 'Varicella post vaccine']",UNK,MERCK & CO. INC.,OT 960828,,,F,"anaphylactic reaction to DPT vaccine made with horse serum; Initial information regarding an unsolicited valid serious case received from non-healthcare professional (consumer) from Pfizer (Reference number: 2021013116) on 11-Jan-2021. This case involved a female patient aged an approximately 3 to 4 year at around years 1964 or 1966 who experienced anaphylactic reaction (Anaphylactic reaction) to DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE made with horse serum. Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, it was reported that the patient developed a serious anaphylactic reaction to DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE made with horse serum (Anaphylactic reaction). No relevant laboratory details were provided. The event of anaphylactic reaction was assessed as medically significant as per important medical event list. It was not reported if the patient received a corrective treatment. Outcome of the event of anaphylactic reaction was unknown. There will be no information available on the batch number for this case.; Sender's Comments: This case involves an approximately 3 to 4 year old female patient who presented with anaphylactic reaction after receiving DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer. Time to onset is unknown. Although, medical history, comorbidities, concomitant medications, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Anaphylactic reaction'],UNK,UNKNOWN MANUFACTURER,OT 960837,NC,33.0,F,G2P1; 19 weeks pregnant; employee felt dizzy and lightheaded after receiving her vaccine. employee given water and Cheez-Its and reported feeling much better.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,PVT,Prenatal Vitamins,Pregnancy,Scoliosis,,NKA,"['Dizziness', 'Exposure during pregnancy']",1,PFIZER\BIONTECH,IM 960841,NY,23.0,M,"Patient developed 104.4 temp approximately 48 hours after being given the vaccine. I treated him with antibiotics, IV fluids, cooling methods. CXR does show a new right perihilar infiltrate. However, his fever came down within the next 24-48 hours. Unfortunately, he suffered a cardiac arrest on 1/21/21 in the early morning and expired.",Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,01/17/2021,01/19/2021,2.0,SEN,"Amantadine, clonazepam, clobazam, lovenox, dextroamphetamine-amphetamine , famotidine, gabapentin, keppra, robinul, polyethylene glycol, propanolol, sertaline, senna, valproic acid, vimpat, cefepime",none,"ventilator dependent, anoxic encephalopathy, seizure disorder",,none,"['Cardiac arrest', 'Chest X-ray abnormal', 'Death', 'Lung infiltration', 'Pyrexia']",1,PFIZER\BIONTECH,IM 960854,FL,35.0,F,Currently 9weeks pregnant with expected due date Aug 21 21. OB office was contacted about reaction and they will continue to monitor during my pregnancy but as of now no signs of harm. Adverse reaction started with minor muscle aches then about 12hr after I started with a fever/ chills that got very severe during the night. Finally around 1am/2am the fever started to break. I took Tyenol 500mg every 4 to 6 hours x 5 doses in the 24hr period.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/18/2021,0.0,WRK,Prenatal Vitamin Levothyroxine 50mcg daily Omega 3,,"hypothyroidism, insomnia",,NKA,"['Chills', 'Exposure during pregnancy', 'Myalgia', 'Oral herpes']",2,MODERNA,IM 960874,OH,24.0,M,"Patient became nauseated at 11pm 1/20/21 and fever of 101, passed out in bathroom dry heaving and woke up at 4am, Heartrate 182, short of breath, continuous vomiting, called EMS, was given zofran on route to ER, upon arrival to ER heartrate reduced to 130's, patient reports being given toradol and IV Fluids, and was released. Patient reports fever range of 101-103.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,PUB,Unknown,Covid-19 3.5 weeks prior,none,,no known allergies,"['Dyspnoea', 'Electrocardiogram', 'Loss of consciousness', 'Nausea', 'Pyrexia', 'Retching', 'Vomiting']",2,MODERNA,IM 960922,NH,93.0,F,"On 01/19/2021 patient was observed to have a slight right facial droop and slight slurred speech, hand grips were equal, pupils equal and reactive, she had difficulty moving her right leg. 911 activated due to possible CVA, admitted to the hospital , a MRI was done to rule out a stroke. Readmitted 1/20/21 with the diagnosis of probable Bell's Palsey. The patient is stable medically at this time. Facial droop remains at this time, she is able to swallow without difficulty.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/07/2021,01/19/2021,12.0,SEN,"ocular vitamins ,bumetanide 0.5mg daily, donepezil 10 mg daily, ferrous sulfate 325 mg daily, levetiracetam 500 mg BID, calcium 600-400,units of D, metoprolol succinate ER 25 mg daily, levothyroxine 88 mcg daily, omeprazole 20 mg daily, ato",none,"diabetes, epilepsy, hx CVA, hypothyroidism, HTN, CHF, osteoporosis, macular degeneration left eye, hyperlipidemia, aortic stenosis, constipation",,,"['Dysarthria', 'Facial paralysis', 'Laboratory test normal', 'Magnetic resonance imaging normal', 'Mobility decreased']",UNK,PFIZER\BIONTECH,IM 960925,VA,67.0,F,"She began to have twitching on the day of vaccine 1/12/2021 but does have a history of seizures secondary to cancer, low grade temp of 99.4 for which she was given tylenol. After the tylenol her fever broke but the lip twitch persisted and her body began to twitch intermittently. She continued to have the twitching throughout the evening and then became unresponsive. She was sent out EMS to our local hospital. She was admitted and returned from the hosptial on 1/19/2021 and state she feels fine. New Diagnosis of Metabolic Encephalopathy",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/12/2021,01/13/2021,1.0,SEN,,,"Acute Kidney Failure, Acute Posthemorrhagic anemia, Other seizures, CVA, Major Depression, Type 2 Diabetes, Essential Hypertension, Morbid Obesity, GERD,",,No known drug allergies,"['Metabolic encephalopathy', 'Muscle twitching', 'Pyrexia', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 960987,GA,80.0,F,HIGH BLOOD PRESSURE AND DROP IN O2 SAT,Not Reported,,Not Reported,Yes,7.0,Not Reported,Y,01/06/2021,01/07/2021,1.0,SEN,"METOPROLOL SUCCINATE, FUROSEMIDE, FLUOXETINE, IRBESARTAN, ATORVASTATIN, MEMANTINE, CENTRUM SILVER MVI, ASPIRIN, MYRBETRIQ, CLOPIDOGREL, ARMOUR THYROID, NITROFURANTOIN",NONE,"HIGH BLOOD PRESSURE, DEPRESSION, HYPERLIDIPDEMIA, DEMENTIA, OVERACTIVE BLADDER, RECURRENT UTI, HYPOTHYROIDISM",,NO KNOWN ALLERGIES,"['Hypertension', 'Oxygen saturation decreased']",UNK,MODERNA,IM 961010,PA,92.0,M,"Resident returned to the memory support unit at 1500. Resident was than toileted and transferred in to bed per his request. At 1515 resident was observed face down beside bed, resident sustained a 1inX1in eccyhmotic/hematoma to the forehead. Neuro Checks with in normal limes Vital signs: 100/52, 100, 97.2, 28. Resident sent to ED for further medical evaluation via EMS.",Yes,01/20/2021,Not Reported,Yes,1.0,Not Reported,U,01/19/2021,01/19/2021,0.0,SEN,,,encephalopathy; gastritis unspecified with bleeding; essential primary HTN; benign prostatic hyperplasia without lower urinary tract sx; hypothyroidism; hyperlipidemia; spinal stenosis; sacral and sacro ccygeal region; anxiety; atrial fibrillation; GERD without esophagitis; edema unspecified; weakness; dementia; hammer toe acquired right foot,,Hydralazine,"['Computerised tomogram head normal', 'Ecchymosis', 'Haematoma', 'Troponin increased']",1,PFIZER\BIONTECH,IM 961055,TX,47.0,M,"Pt started having dizziness, increased HR, extremities became pale, BP increased to 170/94, HR 144 30 mins after injection. Pt tolerated first vaccine s difficulty, sxs continued and BP and HR fluctuated off and on for 1hr. Pt was given an EPI pen, Solumedrol 125mg, Zyrtec (refused benadryl) , and Pepcid 20mg during the episode. HR and BP continued to increase - EMS was called and pt was take to the ED and released ~10pm at night to home.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/20/2021,01/20/2021,0.0,PVT,None,None,none,,Anaphylaxis to peaches,"['Blood pressure increased', 'Dizziness', 'Heart rate increased', 'Pallor']",2,MODERNA,IM 961126,WV,27.0,F,I woke up at 4am to my heart racing. I am a nurse so I checked my pulse and it was 126. I tried to bear down at home to decrease my heart rate but it continued to climb to 164 so after an hour of sustained Hr 126-164 I went to the emergency room where I had SVT. They did a valsalva maneuver 3 times and that made my heart rate go down to the 130s. It was then sinus tachycardia and stayed 120s-130s until about noon. Upon discharge at 3:30pm my resting heart rate was still 105 but it was determined to be a vaccine reaction as all other tests were normal.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/19/2021,01/20/2021,1.0,PVT,Multi vitamin,,Autoimmune thyroiditis,,Keflex,"['Blood thyroid stimulating hormone normal', 'Culture negative', 'Electrocardiogram abnormal', 'Fibrin D dimer normal', 'Full blood count normal', 'Palpitations', 'Pyrexia', 'Sinus tachycardia', 'Sleep disorder', 'Supraventricular tachycardia', 'Troponin normal', 'Vaccination complication']",UNK,PFIZER\BIONTECH,SYR 961168,AR,27.0,F,"She is 11 weeks pregnant EE received 2nd covid vaccine on 1/19 at 0727 and began having s/s 1/20 at 1400: HA, body aches, chills, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/20/2021,1.0,PVT,Anxiety medication,no,no,,no,"['Chills', 'Exposure during pregnancy', 'Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 961170,TX,41.0,F,"41 years 6 month old female with history of thyroid problem. Pregnant 19 weeks. NKDA. G9PA. Meds-Thyroid medication and prenatal vitamins. Patient received COVID-19 vaccine at 10:30AM. 3 minutes later in post vaccine observation area she complained of tingling/numbness in both arms and legs. No loss of strength or weakness. She was anxious and nervous before the vaccine. 10:40AM: BP 170/90 rechecked at 168/90. No shortness of breath, no chest pain, color: pink, lungs clear to auscultation. 10:44AM: BP 160/88 HR-119 O2 Sat-99%. No shortness of breath, stridor. Tachycardia. Color: pink 11:05AM: BP 140/90 HR-109 O2 Sat-98%. Lungs clear to auscultation. HR Tachycardia 11:12AM: BP 138/86 HR-113 O2 Sat-98% Patient informed me that she was nervous and anxious before the vaccine administration Taken by medic to emergency room.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/16/2021,01/16/2021,0.0,OTH,"Thyroid NP 60, Prenatal vitamins",None,Thyroid,,No known allergies,"['Exposure during pregnancy', 'Hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 961179,TX,82.0,F,"Seizure like episode on 1/12/21, one week after vaccine, last 1.5 hours, consisting of both eyes twitching and clenching/spasm of right hand and arm. EMS called. BP normal. Continuing weakness of right arm and right leg, which was side weakened by stroke. Could no longer stand or walk on right leg. Some slurring of speech. Some confusion. Went to hospital 1/14. No evidence of stroke or current seizure. Considered problem to be mild UTI, started antiobiotics, rapid improvement. Discharged 1/17. Woke up 1/18 with aphasia. Went to urgent care, sent immediately to hospital. Doctors found no evidence of stroke or seizure. Consider problem to be due to inflammation, caused by mild UTI (which was cleared by antibiotics) or perhaps due to inflammation caused by Covid vaccination. The inflammation reinitiated the symptoms of her stroke, although she never had expressive aphasia prior to this, only word-finding problems, which had been resolved.",Not Reported,,Not Reported,Yes,3.0,Yes,N,01/05/2021,01/12/2021,7.0,PVT,Metropolol Keppra low dose to prevent seizures from prior stroke (hemorhagic),none,stroke from 18 months prior,,none,"['Aphasia', 'Blepharospasm', 'Confusional state', 'Dysarthria', 'Dysstasia', 'Gait inability', 'Inflammation', 'Muscle spasms', 'Muscular weakness', 'Seizure like phenomena', 'Urinary tract infection']",1,MODERNA,IM 961200,FL,58.0,F,"anaphylaxis - treatment ED / ICU epinephrine, famotidine, methylprednisolone",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/14/2021,01/14/2021,0.0,PVT,"vitamin D glipizide metformin allopurinol potassium and magnesium supplements prn inhaler - Proventil, breo, singulair",none,Celiac and asthma,wheezing after hep b dose 2,"- anaphylaxis to bees, -hives, wheezing with PCN, contrast dye, amoxicillin","['Anaphylactic reaction', 'Intensive care']",1,MODERNA,IM 961281,MI,44.0,F,"near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for Covid 19; lost weight; No sense of taste or smell; No sense of taste or smell; losing hair; heart rate started increasing; high blood pressure; Increased cough; Sleepy; tired; Headache; This is a spontaneous report from a contactable other healthcare professional (patient) through the Medical Information Team and Pfizer-sponsored program Pfizer First Connect. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscularly on the arm on 19Dec2020 11:15 at a single dose for COVID-19 immunization. Medical history included tachycardia and stroke from 2019 and diabetes mellitus diagnosed in summer of 2020 and ongoing. Family medical history included father had type 2 diabetes. Concomitant medication included metformin hydrochloride, sitagliptin (JANUMET) for diabetes. The patient previously took regular flu shot and had body aches; it did not happen at the year of report but in years past she did have it. The patient took the COVID vaccine for precaution as she was a healthcare worker/paramedic and stated there was no prescriber. She received the vaccination at a health department facility, not a military facility. She had no previous immunizations and no additional vaccines were administered on the same date as COVID-19 vaccine. The patient received her first dose of COVID-19 vaccine on 19Dec2020 and after nine days, she tested positive for COVID-19 on 30Dec2020 and had an inpatient hospital stay. She mentioned she was so happy that she did not have any symptoms for those days. She stated that she got the shot on the 19th and later that evening was when she started having symptoms. She tried to sleep and it woke her up, she felt sleepy, tired and experienced headache on 19Dec2020 20:00 to 21:00. On 28Dec2020 23:00, she had an increased cough. She initially had increased cough from wearing mask and was having post nasal drip, then she got wet cough and that was when she decided to get tested. She went back and forth on dates; stated she was confused with the dates because of being in the hospital, it had been a while and the dates were all meshing in together. Her specimen was collected and they did the test on 29Dec2020 then found out that she tested positive for COVID virus with a COVID test nasal swab on 30Dec2020 17:30. She mentioned she lost weight after she got COVID, had no sense of taste or smell on unspecified dates. She did not know if it was related to her thyroid but she started losing hair and her heart rate started increasing on Monday, so they took her off all her meds and said the COVID was doing crazy things to the body. She had to go on Carvedilol for the sinus tachycardia and had high blood pressure now. This was all new after she tested positive. She has had bouts of tachycardia before and did have a heart monitor as she had a stroke last year. So those have never been persistent or symptomatic. If she did have a high heart rate, it always went down. This one was symptomatic. She did fine the whole week after the shot, just had that little bit of sleepiness, was tired, and had a headache. The patient reported near syncope with sinus tachycardia due to COVID-19 and hypothyroidism on 08Jan2021 14:30 to 15:00, which required hospitalization from 08Jan2021 to 10Jan2021 (2 days). ER or physician's office was required. She never went to the ER for the vaccination, it was just for the near syncope with sinus tachycardia due to COVID-19 and hypothyroidism that she went and was then admitted to hospital. She just got out of the hospital the day before report (10Jan2021), was there for two days and was still recovering. She was supposed to receive her second vaccination on the day of report however her doctor did not know if she should get the second dose due to double antibodies. She did not ask if she still had the virus or it went away. She has not been to work in two weeks. Outcome of the events tested positive for COVID virus was not recovered; near syncope with sinus tachycardia due to COVID-19 and hypothyroidism was recovered with sequel; sleepy, tired and headache was recovering; while the remaining events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/19/2020,12/19/2020,0.0,PUB,JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN],,Medical History/Concurrent Conditions: Diabetes; Stroke; Tachycardia,,,"['Ageusia', 'Alopecia', 'Anosmia', 'COVID-19', 'Cough', 'Fatigue', 'Headache', 'Heart rate increased', 'Hypertension', 'Hypothyroidism', 'Impaired work ability', 'Presyncope', 'SARS-CoV-2 test positive', 'Sinus tachycardia', 'Sleep disorder', 'Somnolence', 'Upper-airway cough syndrome', 'Weight decreased']",UNK,PFIZER\BIONTECH,OT 961282,MA,49.0,F,"Felt like a restless leg or blood clot but not as severe.; Felt like a restless leg or blood clot but not as severe.; Left below knee pain and discomfort. Some to the right leg as well.; Left below knee pain and discomfort. Some to the right leg as well.; Checked back of leg for warmth or bruising lasted day 2 and day 3.; Checked back of leg for warmth or bruising lasted day 2 and day 3.; Did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort; This is a spontaneous report from a contactable nurse reporting for herself. A 49-years-old female patient started to receive bnt162b2 (BNT162B2; Lot: ECO142) vaccine , intramuscular in the left arm on 29Dec2020 15:45 at single dose for Covid-19 immunisation . Medical history included hypertension, anaemia, blood cholesterol increased , depression, food allergy (whey casium) (taking doxepin for it with relief). Concomitant medication included doxepin (DOXEPIN), metoprolol (METOPROLOL), calcium ascorbate (VITAMIN C [CALCIUM ASCORBATE]), tocopherol (VITAMIN E [TOCOPHEROL]), cyanocobalamin (VITAMIN B-12) , atorvastatin (ATORVASTATIN), sertraline (SERTRALINE). The patient experienced felt like a restless leg or blood clot but not as severe. on 30Dec2020 07:00 with outcome of recovered , left below knee pain and discomfort. some to the right leg as well. on 30Dec2020 07:00 with outcome of recovered , checked back of leg for warmth or bruising lasted day 2 and day 3. on 30Dec2020 07:00 with outcome of recovered , did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort on 30Dec2020 07:00 with outcome of recovered. The event blood clot was considered serious (Important Medical Event). Course of the events The patient reported left below knee pain and discomfort. Some to the right leg as well. She checked back of leg for warmth or bruising lasted day 2 and day 3. She felt like a restless leg or blood clot but not as severe. She felt better to stand instead of sitting. Did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort. No shortness of breath, no nausea, no dizziness, no increased fatigue (baseline - not enough sleep - working 3 jobs).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported leg thrombosis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,OTH,; ; VITAMIN C [CALCIUM ASCORBATE]; VITAMIN E [TOCOPHEROL]; VITAMIN B-12; ;,,Medical History/Concurrent Conditions: Anemia; Blood pressure high; Depression; High cholesterol; Protein allergy (whey casium - slight allergy taking doxepin for it with relief),,,"['Limb discomfort', 'Pain', 'Pain in extremity', 'Tenderness', 'Thrombosis']",1,PFIZER\BIONTECH,OT 961283,,,U,"heart complications; brain complications; Initial information received on 12-Jan-2021 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional. This case involves patient (unknown demographics) who experienced serious heart complications (cardiac disorder) and brain complications (nervous system disorder), when received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]. The patient's past medical treatment, vaccination, concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On 20-Sep-2020, the patient who do not expect to survive after development of serious heart complications (cardiac disorder) and brain complications (nervous system disorder) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant and life-threatening and was leading to disability. The patient was hospitalized for these events. It is unknown if the patient experienced any additional symptoms or events. Medication details and reason for taking the medicine was not provided It is unknown if there were lab data or results available It was not reported if the patient received a corrective treatment. On 24-Nov-2020, the patient recovered from both the events.; Sender's Comments: A patient (unknown demographics) presented with cardiac disorder and nervous system disorder following the vaccination with FLUZONE HIGH DOSE. Time to onset is unknown. Medical history, concomitant medication, precise final diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.",Not Reported,,Yes,Yes,,Yes,Y,,09/20/2019,,UNK,,,,,,"['Cardiac disorder', 'Nervous system disorder']",UNK,SANOFI PASTEUR,OT 961339,GA,45.0,F,"possibly got it at clinic, possibly who administered shot. Pts. daughter said the pts boyfriend denied any symptoms the whole day but that in the middle of the night the pt passed away.",Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/19/2021,1.0,WRK,"Wellbutrin, Ambien",,"COPD, Sleep apnea",,contrast die,['Death'],UNK,MODERNA,SYR 961349,TN,23.0,F,"Pt's injection was given into the bony prominence at acromion process . Pt reported immediate entire arm went numb immediately with immediate pain. She went back home to Ohio and was seen on 1/10 given a Medrol dose pack and sling. Instructed to rest and Ice the area. Initially the pain seem to improve after steroids, After finishing steroids and returning to work pain and limited ROM has continued to increase. Reports pain at injection site that becomes sharp and worse with certain movements Her fingertips feel like pens & needles.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/08/2021,01/08/2021,0.0,PVT,Pt given Medrol dose pack on 1/10/2021 as well as taking Naproxen. Pt given another dose of Medrol on 1/21/2021,None,None,,NKDA,"['Hypoaesthesia', 'Immediate post-injection reaction', 'Injection site pain', 'Joint range of motion decreased', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Product administered at inappropriate site', 'X-ray limb']",2,PFIZER\BIONTECH,OT 961434,OH,94.0,M,This is a 94-year-old male who is brought in by ambulance after being found on the floor with unknown downtime. He was in asystole upon EMS arrival. He remains in asystole. No advanced airway is in place. The patient is getting compressions from Lucas device upon arrival. It was reported that he was last talked to by family at 2 PM. The patient got his SARS-CoV-2 vaccination this morning. The patient is evaluated emergently. CPR was ongoing with 3 rounds of epinephrine given. The patient remains in asystole. He has rigor mortis. The patient's pupils are fixed and dilated. The patient has compressions paused and ultrasound is used to evaluate for cardiac activity. None is detected. The patient has no electrical activity on monitor. The patient's time of death is 2113.,Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,OTH,Tamsulosin 0.4 mg daily Metoprolol Succinate ER 100 mg daily Rivaroxaban 15 mg daily Levothyroxine 100 mcg daily Furosemide 40 mg daily Atorvastatin 40 mg daily Amiodarone 200 mg daily Nitroglycerin 0.4 mg SL PRN Aspirin 81 mg daily Polyeth,Chronic back pain,"Cardiovascular LBBB (left bundle branch block) HTN (hypertension) Pure hypercholesterolemia CAD (coronary artery disease) Acute systolic heart failure (HCC) Atrial fibrillation (HCC) � Nephrology Stage 3 chronic kidney disease � Endocrinology Controlled type 2 diabetes mellitus with microalbuminuria, without long-term current use of insulin (HCC) Amiodarone-induced thyroiditis � Other BPH (benign prostatic hyperplasia)",,No know allergies,"['Cardiac arrest', 'Death', 'Echocardiogram abnormal', 'Musculoskeletal stiffness', 'Pulseless electrical activity', 'Pupil fixed', 'Resuscitation']",1,PFIZER\BIONTECH,IM 961479,FL,55.0,F,"several fainting spells because of everything going on; elevated HR in the 130's; Uncontrollable chills; fever of 102.8; pain all over my body; intractable vomiting; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EL0140, via an unspecified route of administration in left arm on 07Jan2021 10:45 at single dose for covid-19 immunisation. Medical history included covid-19 on an unknown date prior vaccination. There were not known allergies. Covid was not tested post vaccination. Concomitant medication included vitamin D; vitamin E. On 08Jan2021 at 02:00 the patient experienced several fainting spells because of everything going on, uncontrollable chills, fever of 102.8, pain all over the body, elevated heart rate in the 130's, and intractable vomiting. The patient was not treated for the events. The outcome of the events was resolved in Jan2021.; Sender's Comments: Based on the time association, all events are reasonably related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,VITAMIN D;VITAMIN E,,Medical History/Concurrent Conditions: COVID-19 (covid prior vaccination: Yes),,,"['Chills', 'Heart rate increased', 'Pain', 'Pyrexia', 'Syncope', 'Vomiting']",1,PFIZER\BIONTECH, 961489,MI,37.0,F,"Lupus flare, intractable pain, chest pain; patient received prolonged infusion of ketamine",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/11/2021,01/14/2021,3.0,PVT,Firorinal 325mg-50mg-40mg Norflex 100 mg Nurtex ODT 75 mg Saxenda 18mg/3mL sq Slynd 4mg Soma 250 mg Topamax 25 mg Trokendi XR 100 mg Vraylar 3mg cetirizine 10 mg chlorprmazine 25 mg dihydroergotamine 1mg/mL gabapentin 300 mg lamotridine 100,,SLE Migraine Insomnia Anxiety Disorder Bipolar PTSD POTS Hypothyroidism,,No known allergies,"['Chest X-ray normal', 'Chest pain', 'Condition aggravated', 'Pain', 'Red blood cell sedimentation rate normal', 'SARS-CoV-2 test negative', 'Systemic lupus erythematosus', 'White blood cell count normal']",2,PFIZER\BIONTECH,IM 961499,OH,36.0,M,Severe thrombocytopenia platelet count of 1.,Not Reported,,Yes,Yes,1.0,Not Reported,N,01/05/2021,01/20/2021,15.0,MIL,Lamotrigine Levetiracetam Ibuprofen PRN last dose 1 week ago,None,Epilepsy,,No,"['Platelet count decreased', 'Thrombocytopenia']",1,MODERNA,IM 961501,MN,43.0,M,"After the required wait period of 15 minutes I started to drive back home which is 77 miles from the hospital that administered the vaccination. Around 15 minutes down the road I started feeling like something was caught in my throat and was coughing a little. At that time I decided to turn around and go back to the hospital. I took an oral Benadryl 25mg and decided to wait in my car and see if it was something else. After 30-45 minutes I took a drink of water and realized I was having trouble swallowing. I then preceded into the ER and was admitted immediately. In the ER, they started an IV, administered Benadryl, methylprednisolone and a bag of saline. The physician discussed with me and we agreed to hold the Epinephrine to see how I reacted to the previous medications. I was then monitored for a couple hours then released with a prescription of Prednisone 60mg for 5 days and an EpiPen. One day out, no new symptoms besides injection site pain.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/20/2021,01/20/2021,0.0,PVT,"Lisinopril, Omeprazole, Ibuprofen",,,,Amoxicillin,"['Cough', 'Dysphagia', 'Injection site pain', 'Sensation of foreign body']",2,PFIZER\BIONTECH,IM 961503,MD,34.0,F,"I am a resident physician/ employee at the Hospital. I developed acute perforated appendicitis 56 hours after receiving the 2nd dose of Pfizer COVID vaccine. I received the vaccine on 1/12/21 and developed symptoms of epigastric pain and vomiting on 1/14/21. On 1/15/21, I developed fever and right lower quadrant pain that was sustained. I presented to the Hospital Emergency Department on 1/17/21 and was diagnosed with acute perforated appendicitis by CT with contrast. I underwent emergency appendectomy at The Hospital on 1/17/21 and was hospitalized from 1/17/21-1/19/21.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,01/12/2021,01/14/2021,2.0,PVT,None,None,None,,None,"['Abdominal lymphadenopathy', 'Abdominal pain lower', 'Abdominal pain upper', 'Appendicectomy', 'Appendicitis perforated', 'Computerised tomogram abdomen', 'Computerised tomogram abdomen abnormal', 'Pyrexia', 'Scan with contrast abnormal', 'Vomiting', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 961533,AR,46.0,F,Patient developed one singular area of urticaria approximately one hour after the vaccination and then developed an anaphylactoid reaction 3 days later including widespread urticaria and chest tightness. She took OTC antihistamines and recovered 6 days after the vaccine.,Not Reported,,Yes,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,UNK,None,None,None,,NKDA,"['Anaphylactoid reaction', 'Chest discomfort', 'Urticaria']",UNK,PFIZER\BIONTECH, 961587,MA,20.0,F,"Anaphylactic Reaction. Treatment with Epinephrine, Benadryl, Solumedrol, Albuterol and Atrobent",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/21/2021,0.0,PUB,"Albuterol Inhaler, PRN",None,Asthma,,Shellfish,['Anaphylactic reaction'],1,MODERNA,IM 961589,NC,80.0,M,"Patient reports intermittent left land paresthesias lasting about 10 minutes with a glove distribution just in the hand initially on 1/16/21. On 1/18/21, patient had symptoms lasting about 4 hours and could not pick up objects. By the time he came to the ER for this, symptoms had resolved. On Tues, 1/19, patient went skeet shooting and experienced an episode of numbness involving the entire left arm from shoulder to fingertips, involuntary hand movements, and left cheek twitching. These symptoms lasted about 10 minutes. Patient also reported dysarthria, slurred speech, strange sensation on left side of face, and facial asymmetry. His wife reports his voice was a whisper and patient's left arm was dangling at his side. Reports voice feeling weak along with these symptoms.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/13/2021,01/16/2021,3.0,PVT,"Ocean nasal spray, Flonase nasal spray, naproxen tab, vitamin D tab, Prolia injection, multivitamin tab, methotrexate tab, Hydromet syrup, folate tab, Orencia injection, Priloscec cap, 1 glass of wine/day","Endocrine (partial thyroidectomy - left lobe removed), reflux, arthritis (rt knee replacement)","Endocrine (partial thyroidectomy - left lobe removed), reflux, arthritis (rt knee replacement)",,none,"['Blood culture', 'CSF culture negative', 'CSF white blood cell count', 'Computerised tomogram head normal', 'Cryptococcus test', 'Dysarthria', 'Dyskinesia', 'Dysphonia', 'Facial asymmetry', 'Fungal test', 'Grip strength decreased', 'Hypoaesthesia', 'Laboratory test', 'Lumbar puncture abnormal', 'Magnetic resonance imaging brain abnormal', 'Muscle twitching', 'Musculoskeletal disorder', 'Mycobacterium test', 'Paraesthesia', 'Sensory disturbance', 'Viral test']",1,PFIZER\BIONTECH,IM 961599,AR,40.0,F,"started having asthma attacks (chest pain and Shortness of breath with wheezing) on friday 01/15/2021 Didnt get any better over weekend. was taking inhaler every 3-4 hours. Monday was tested for covid which was negative. body aches and fatigue began over weekend. asthma progressively got worse. On 01/20 had to visit dr office, my neck was swollen on both sides, injection site had a raised large area that extended from my shoulder to my elbow. Up until yesterday, you could not even tell where I had the shot. Now there is still a raised area and you can tell exactly where i recieved it.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/05/2021,01/15/2021,10.0,PHM,Vitamin D Busbar klonipin,,"bipolar 1, allergy induced asthma, general anxiety disorder, PTSD",,"sulpha drug, septra drug, robitussin, mucinex, augmentin","['Asthma', 'Chest pain', 'Condition aggravated', 'Dyspnoea', 'Fatigue', 'Injection site swelling', 'Pain', 'SARS-CoV-2 test negative', 'Swelling', 'Wheezing']",UNK,MODERNA, 961679,GA,59.0,F,"I received the Covid vaccine on December 21. On December 30, I woke up and was unable to maintain my balance. I developed very severe migraine headaches and was hospitalized. I still have not regained my balance. I have had a couple of courses of prednisone and migraine medication. My neurologist is setting up IV I G transfusions feeling that I?m having an auto immune response to the vaccine.",Not Reported,,Not Reported,Yes,4.0,Yes,N,12/21/2020,12/30/2020,9.0,PVT,"Metoprolol, hydrochlorothiazide, Wellbutrin, Celexa, Prilosec",None,"HTN, Depression",,"PCN, Topical Iodine","['Angiogram cerebral', 'Balance disorder', 'Computerised tomogram head', 'Laboratory test', 'Magnetic resonance imaging brain', 'Migraine']",1,PFIZER\BIONTECH,SYR 961703,AZ,31.0,F,"Received vaccination in left deltoid, within a few minutes arm started feeling numb and tingling distal to vaccination site. She describes it feeling like she slept on it wrong. It is beginning to feel better with time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,OTH,Paxil,none,history of depression,,NKDA,"['Injection site hypoaesthesia', 'Injection site paraesthesia']",1,MODERNA,IM 961705,OH,60.0,M,"approximately 3 hours prior to expiring the patient was experiencing forceful emesis. later was found to have expired, patient was comfort care only.",Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/20/2021,2.0,SEN,"Phenergan, melatonin, clonazepam, vit d, asorbic acid, zinc, cholecalciferol, lomotrigine, cimetadine, quetiapine,",none,"Frontotemporal dementia, copd, type 2 diabetes with kidney disease, Anxiety, Atherosclerotic heart disease, covid 19 on 10/15/2020",,no known allergies,"['Death', 'Vomiting projectile']",2,PFIZER\BIONTECH,IM 961741,NY,89.0,M,"The�patient�received�his�vaccine�in�the.�morning�of�1/20/2021,�while�getting�into�car�to�go�see�his�pulmonologist,�about�2�hours�after,�collapsed,�unresponsive�with�asystolic�cardiac�arrest.��No�symptoms�prior�other�than�chronic�dyspnea.��No�allergic�type�symptoms�reported�by�family.��Asystole�with�EMS,�no�response�to�ACLS,�presented�to�ED,�DOA.",Yes,,Not Reported,Not Reported,,Not Reported,,01/20/2021,01/20/2021,0.0,OTH,,copd/chf/sleep�apnea/afib/lymphoma,as�above,,,"['Cardiac arrest', 'Syncope', 'Unresponsive to stimuli']",UNK,UNKNOWN MANUFACTURER, 961776,FL,69.0,M,"1/13/2021 12:00 PM: Patient received COVID-19 Vaccine. 1/14/2021 21:00: Nurse performed routine rounds and the patient appeared okay. 1/14/2021 22:00: CNA discovered patient unresponsive in bed, began CPR, and called 911. 1/14/2021 23:08: Pronounced deceased.",Yes,01/14/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,SEN,"Acetaminophen 325mg, Aspirin 81mg, Celecoxib 200mg, Docusate Sodium 100mg, Furosemide 40mg, Glimepiride 2mg, Lantus SoloStar 100unit/ml Pen-Injector, NovoLog FlexPen 100 Unit/ml Injection Pen, Senokot 8.6mg, Nu-Iron 150mg, Lisinopril, 20mg,",None,"Hypertension, Type 2 Diabetes",,None Known,"['Death', 'Resuscitation', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 961839,NY,41.0,F,"tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female (no pregnant) patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686) on 05Jan2021 10:15AM at Upper Left Arm for COVID-19 immunization. Medical history and concomitant drug were not reported. She said she got Botox injections in her forehead, as well as, a little bit by each eye, a little less than 3 weeks prior to receiving the COVID-19 Vaccine. She clarified she believes she was injected with only 50cc's of a Botox 100mg vial. She said she does not have the Botox NDC, Lot, and Expiration Date from the Botox that was injected into her forehead and eye areas approximately 3 weeks earlier. Patient got the 1st shot of covid vaccine on 05Jan2021. On Monday she had symptoms of bells palsy and wanted clinic trials result for it. Reported her Bell's Palsy symptoms started on Monday, 11Jan2021, and she was formally diagnosed with Bell's Palsy in the right side of her face in the Emergency Room on 12Jan2021 was reported as worsened. She said the doctor told her the Bells Palsy could worsen before it improves. She said the doctors ruled out a stroke and diagnosed her with Bells Palsy. Stated she has tingling in her right arm that comes and goes on 12Jan2021. She doesn't have the right arm tingling all the time. Event details: On Saturday, 09Jan and Sunday 10Jan my right eye began to twitch from time to time. I woke up on Monday very tired and my eyes were swollen and I had bags under my eyes. I felt a little off but went to work. In the middle of the day my right eye began hurting with a burning sensation. I thought I needed to change my contact lenses. The following day, Tuesday 12Jan. I woke up and noticed that I can't fully close my right eye. I felt tired again and my eyes had bags under them. I went to work and felt like not myself. Around 10am, I ate cereal and noticed that I was chewing funny. At 1:30 pm I felt tingling around my right lip and at 4pm I noticed that smile is off and that I was not able to smile fully with my right side. That was when I went to the Emergency Room. She said she was given 3 Prednisone 20mg pills while she was at the hospital yesterday, as well as, a prescription for Prednisone 20mg tablets. She said she is to take 3 Prednisone 20mg tablets per day for 6 days. She clarified once she finishes the Prednisone 20mg prescription, she will have taken 7 days of Prednisone 20mg tablets. She stated the Prednisone 20mg tablets were dispensed in a pharmacy vial, and she does not have the NDC, Lot and Expiration Date. She said she also received a prescription for Valacyclovir 1gm tablets. She said she is to take 1 Valacyclovir 1gm tablet, three times a day, for 7 days. She said the Valacyclovir 1gm tablets are dispensed in a pharmacy bottle, and she doesn't have the Valacyclovir 1gm NDC, Lot and Expiration Date. She said she doesn't want to get the second COVID-19 Vaccine dose now. No Covid prior vaccination. Covid tested post vaccination (Nasal Swab): Yes- Negative. Outcome of reaction/event at the time of last observation was Not Recovered/Not Resolved. Follow-up attempts are completed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/11/2021,6.0,PVT,,,,,,"['Blepharospasm', 'Eye irritation', 'Eye pain', 'Eye swelling', 'Eyelid function disorder', 'Facial asymmetry', 'Facial paralysis', 'Fatigue', 'Feeling abnormal', 'Laboratory test normal', 'Mastication disorder', 'Paraesthesia', 'Paraesthesia oral', 'Periorbital swelling', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 961840,GA,41.0,F,"hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakness; joint hurting; fever; chills; whole body aches; restless; joints and muscles were hurting; She saw really bad redness and it was increasing in size; It was swollen and warm to touch; It was swollen and warm to touch; she has had horrible feelings; inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); Cellulitis; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 09Jan2021 at 10:30 a.m. at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medication were not reported. The patient received first dose on 21Dec2020 (lot number: EJ1685) on left Arm. Patient received second dose of the Pfizer COVID19 Vaccine on 09Jan2021 at 10:30 a.m. and until 11 that night she had no symptoms. She started feeling weakness and joint hurting. After midnight she had fever, chills, and whole body aches. She was restless. All her joints and muscles were hurting. The chills were really bad. She was taking Motrin 200mg and she took three pills at the time, so she took high dose kind of. It didn't get better until Monday, 11Jan2021, at around 1:00PM. It was She stayed home. She has heard from so many people that the second dose gives this kind of symptoms. She was already prepared with the medication. She knew the symptoms would get better. She didn't just right away go to the doctor. For two days she was running all the symptoms. Patient commented also that the last two days she has had horrible feelings. She didn't pay attention to the arm. With any shot, pain is normal. She was getting better with the other symptoms, but was feeling more pain in her hands. She saw really bad redness and it was increasing in size. It was spreading. When moving her arm, it was radiating under the arm and to the side of her breast. Then she felt really bad and came to work. She showed it to her friend and it was spreading and hurting. It was swollen and warm to touch. She went to Urgent Care downstairs. On 12Jan2021 at 10:50AM she went to Urgent Care and was diagnosed with cellulitis in left upper arm. Antibiotics were prescribed as treatment. She informed took vitamins. At the time of the reporting event outcome was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162BB2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/12/2021,3.0,PVT,,,,,,"['Arthralgia', 'Asthenia', 'Chills', 'Erythema', 'Feeling abnormal', 'Injection site cellulitis', 'Myalgia', 'Pain', 'Pain in extremity', 'Pyrexia', 'Restlessness', 'Skin warm', 'Swelling']",2,PFIZER\BIONTECH, 961841,FL,83.0,F,"had trouble breathing; toung was greatly swolen; This is a spontaneous report from a contactable consumer (patient) reported that an 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiration date: not reported), via an unspecified route of administration in the left arm on 11Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included very mild chronic obstructive pulmonary disease (COPD) from an unknown date. Concomitant medications included sertraline, temazepam, levothyroxine and pravastatin. It was reported that on 11Jan2021, the patient had injection at 9:30 am then at 6 pm, had trouble breathing and tongue was greatly swollen (reported as ""toung was greatly swolen""). The patient called ambulance and went to emergency room/department or urgent care. As treatment, the patient received saline IV, banophen and prednisone. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,PUB,; ; ;,,Medical History/Concurrent Conditions: COPD (very mild),,,"['Dyspnoea', 'Swollen tongue']",1,PFIZER\BIONTECH, 961842,VT,40.0,F,"temperature elevated (99.8, 101.8, 101); at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain; at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain; She is very achy; shooting pain all the way down from her left upper deltoid to her middle and ring finger on left hand; This is a spontaneous report from a contactable nurse (patient). This 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ1686) intramuscular, in left deltoid, on 11Jan2021 at 10 AM, COVID-19 immunization. Prior vaccinations (within 4 weeks) or on the same day: none. Medical history included ongoing asthma diagnosed at childhood, ongoing diabetes diagnosed in her twenties, she was overweight, about 7 or 8 years ago she ended up having cellulitis due to the nurse not using aseptic technique but not due to a vaccine, she was diagnosed with COVID on 18Dec2020 (she was off quarantine as of 28Dec2020, going back to work on 31Dec2020). When she was diagnosed with COVID, it caused an asthma exacerbation and she needed a 5-day oral burst of 40 mg prednisone. Concomitant medications were none. On 11Jan2021 the patient experienced temperature elevated, at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain and she was very achy. Her temperature started last night (11Jan2021), temperature was 99.8. She tried to hydrate. She also had a temperature at 6 AM on 12Jan2021 morning. On 12Jan2021 she had temperature of 101.8 and this was after taking antipyretics 6 hours before. Then, on 12Jan2021, her temperature was 101. She was on the phone with her primary care provider and she was told to take more antipyretics. She just took more antipyretics. She stated it felt almost like they hit a nerve when administering the vaccine since she was experiencing shooting pain all the way down from her left upper deltoid to her middle and ring finger on left hand. She believed, based on anatomy, that there were nerves going right there. She knew she was overweight but her upper arms were not that bad. She tried to take a shower to cool herself down. She received the vaccine through pharmacy since she was working at a long term care facility around COVID. Pharmacist came to the long term care facility where she works to administer the vaccine. The events did not require ER visit. Relevant tests: none. Fever outcome was unknown. The other events had not yet resolved. Sharp shooting pain came and went. The reporter considered all the events serious as medically significant and related to BNT162B2 vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/01/2021,,UNK,,Asthma (diagnosed at childhood); Diabetes (diagnosed in her twenties); Overweight,"Medical History/Concurrent Conditions: Cellulitis (about 7 or 8 years, due to the nurse not using aseptic technique but not due to a vaccine); COVID-19 (off quarantine as of 28Dec2020, going back to work on 31Dec2020); Quarantine",,,"['Body temperature increased', 'Injection site erythema', 'Injection site pain', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,OT 961843,VA,52.0,F,"Heart attack / she had a MI / diagnosed as a NSTEMI; This is a spontaneous report from a contactable healthcare professional (patient). This 52-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm, on 07Jan2021, for COVID-19 vaccination. Medical history included autoimmune thyroiditis (Hashimoto's thyroiditis) from 1998 and vitiligo from 1988. She was overweight. She had really no other risk factors. Concomitant medications were not reported. On 08Jan2021 the patient experienced heart attack and she had a MI, then a cardiac catherization that was normal and a normal echo as well. She said it was diagnosed as a NSTEMI and not a large MI, the smaller version. These events required hospitalization from 08Jan2021 to 12Jan2021. MI occurred after she finished clinic and she was not standing or doing anything, just sitting and she had chest pain. Her office was right next to the ER, so she received treatment within an hour and they were able to help her. She said that her hospital couldn't do a cardiac cath, so on 11Jan2021 they moved her to an hospital which was another treatment facility. When she had her MI they gave her acetylsalicylic acid (ASPIRIN) and sublingual nitroglycerin. They tested her troponin and did an EKG which was abnormal on an unspecified date in Jan2021. On 08Jan2021 troponin was increased. When they treated her with nitroglycerin and Aspirin, two hours later her EKG was normal and her troponin came down overnight on 09Jan2021, which was when they said for sure that she had a heart attack. The patient said it was very scary to have a heart attack, but thankfully there was not a lot of damage done and she was able to get treatment quickly. She did not think the event was disabling since they did not see much damage to her heart muscle, it was a near miss kind of thing. She said it was life changing in that she will now be on medication forever, she will be on at least a baby Aspirin and probably something like a statin for the rest of her life. She was recovering, it was unknown what the lasting effects may be, she felt normal but tired from her hospital stay. Heart attack resolved on 08Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event acute myocardial infarction cannot be excluded. The contributory role of the patient age and background of obesity cannot be excluded as well. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/07/2021,01/08/2021,1.0,MIL,,Overweight,Medical History/Concurrent Conditions: Hashimoto's thyroiditis; Vitiligo,,,"['Acute myocardial infarction', 'Catheterisation cardiac normal', 'Chest pain', 'Echocardiogram normal', 'Electrocardiogram abnormal', 'Fatigue', 'Myocardial infarction', 'Troponin increased']",1,PFIZER\BIONTECH, 961844,TX,97.0,F,"Every time my mother blows her nose or coughs up phlegm there is a lot of blood; Every time my mother blows her nose or coughs up phlegm there is a lot of blood; This is a spontaneous report from a contactable consumer (patient's daughter). A 97-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 as a single dose for COVID-19 immunization, lot number: EL0142. Medical history and concomitant medications were reported as none. Patient's daughter reported severe problems with the vaccine. Every time patient blows her nose or coughs up phlegm there is a lot of blood, onset date unknown. No treatment received for the events. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Epistaxis', 'Haemoptysis']",1,PFIZER\BIONTECH, 961845,,77.0,M,Narrative:,Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/17/2021,5.0,OTH,,,,,,['Death'],1,MODERNA,IM 961846,,77.0,M,"Narrative: 1/20/21 Vomited x3 nonbilious and was found to have a fever (100.4 degrees F). Pt reports fullness, saying his belly feels hard. on exam abd distended / tympanic abdomen, decreased bowel sounds. Trafered from clinic to acute care to r/o acute abdomen. 1/19 vaccine given 1/17 - abdomen visibly rounded, patient looks uncomfortable. Patient denied pain x 3, reports feeling full. Abdomen is soft, nontender. Normoactive bowel sounds x 4 - scheduled to receive enema on 1/18. 1/16: noted to have a distended stomach, positive bowels sounds denied pain or discomfort. Ate 50% of dinner, During pm care abdomen noted to be more distended than at the start of shift. - txed with suppository Patient has BM. PMH includes dementia, hypothyroidism, dysphagia, ataxia, drug-induced tremor, schizoaffective disorder, chonic constipation, anemia, bipolar, HL",Not Reported,,Not Reported,Yes,,Not Reported,U,01/19/2021,01/20/2021,1.0,OTH,,,,,,"['Alanine aminotransferase normal', 'Aspartate aminotransferase normal', 'Bilirubin conjugated normal', 'Blood albumin normal', 'Blood alkaline phosphatase increased', 'Blood bilirubin normal', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine normal', 'Blood glucose normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea normal', 'Carbon dioxide normal', 'Gastric dilatation', 'Gastrointestinal sounds abnormal', 'Glomerular filtration rate', 'Granulocyte count', 'Granulocyte percentage', 'Haematocrit decreased', 'Haemoglobin decreased', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Platelet count normal', 'Protein total normal', 'Pyrexia', 'Red blood cell count decreased', 'Red blood cell nucleated morphology', 'Red cell distribution width', 'SARS-CoV-2 test negative', 'Vomiting', 'White blood cell count increased']",2,MODERNA,IM 961848,,76.0,M,"Narrative: Was pt previously covid positive?- Yes. Initial- 10/27/2020, 11/29/2020, 12/22/2020 Are there any predisposing factors for patient experiencing adverse drug event?- Yes, patient had multiple co-morbidities including GI bleed, hepatitis congestion due to cardiac issues, treatment for PE, NSTEMI, or antibiotics for PNA, also on concurrent medications APAP, Atorvastatin, Mirtazapine and Duloxetine. Pt with 2 doses of covid-19 vaccine, second one on 01/08/2021, 2 days pre-death Any occurrence of an ADR at time of administration? Did not specify injection site issues, per RN admin note- Vaccine ""administered without complications."" Did patient recover from event? Not s/p dose on 01/08/2021. First dose given on 12/21/2021, LFTS increased ~01/01/2021, peaked on 01/03/2021 and were decreasing on 01/07/2021 Was there an ADR between observation period and date of death? No Did patient recover from event? No (01/08/2021 event, died 01/10/2021) Was patient hospitalized prior to vaccination? Yes, in between inpatient and nursing home Was patient hospitalized prior to death--was hospitalization attributable to ADE? Yes re-admitted to inpatient on 12/31/2020. GI bleed Is there an alternative cause of death? Yes, as noted above. Quite a complicated case with many comorbidities/concurrent medications as noted above. Primary Diagnosis: Upper GI Bleed in the death note from 01/10/2021",Yes,01/10/2021,Not Reported,Not Reported,,Not Reported,N,,01/09/2021,,OTH,,,,,,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Condition aggravated', 'Death', 'Gastrointestinal haemorrhage', 'Liver function test increased', 'Upper gastrointestinal haemorrhage']",1,PFIZER\BIONTECH,IM 961876,,45.0,F,Covid Vaccine given on 1/5. Headaches started within two hours. Fatigue and headache next two days. Followed by leg weakness in both legs and uncontrollable tremors in my entire body. I was hospitalized for 5 days. I am still having headaches and shakes all over my body with major weakness all over.,Not Reported,,Not Reported,Yes,,Not Reported,,01/05/2021,01/05/2021,0.0,UNK,,,,,,"['Asthenia', 'Fatigue', 'Headache', 'Muscular weakness', 'Tremor']",UNK,UNKNOWN MANUFACTURER, 961879,TX,81.0,M,"My 81-year-old father, and my brother received the first dose of the Pfizer covid vaccine at the Hospital on Wednesday January 13, 2021. Within a couple of minutes of them returning home, my father collapsed. As it turns out, he'd had a silent heart attack. He is still in the medical center area Hospital this morning. A cardiologist who was filling in for my father's primary cardiologist thought maybe my father had a blockage and might have needed a stent. But when Dr. performed a cardiac catheterization, he only found a little plaque. Medical personnel are not too sure what caused the heart attack. My was very dehydrated when he was admitted, and he has underlying health conditions including diabetes, high blood pressure, dementia and a history of blood clots. Those are just a few of his health issues. His primary cardiologist, Dr is back in town. He plans to see if my father has AFib before they release him. I believe Dr. an internist at Hospital, said my father's INR on admitting was 1.2. My father's hematologist, Dr., had told us to let the person administering the vaccine know that my father is on blood thinners. I was not present when my father and brother received the vaccine, but I assume my brother passed that information on to them.",Not Reported,,Not Reported,Yes,,Not Reported,,01/13/2021,01/13/2021,0.0,UNK,,,"Diabetes, high blood pressure, dementia, congestive heart failure, blot clotting history, childhood asthma, tumor on one adrenal gland",,"Cipro, Flomax","['Catheterisation cardiac normal', 'Dehydration', 'International normalised ratio increased', 'Silent myocardial infarction', 'Syncope']",UNK,PFIZER\BIONTECH, 961882,NV,28.0,F,"Sars-CoV-2 vaccine (pPp treatment under Emergency Use Authorization(EUA): pfizer Received COVID-19 Vaccine at 10:45 AM. After 10 minutes post administration, while being monitored began feeling nauseated and c/o some dizziness. Denies allergies or prior events with vaccination. A& O x3, pale, diaphoretic, weak radial pulse, cool w/ delayed cap refill. Preferred to sit with her head lowered rather than supine. VS noted and cool cloths provided. Stated she ate a little this AM, BP and pulse normally low for her and currently on menstrual cycle. Advised to stay additional 15 min. VS rechecked w/o change in symptoms. Agreed to lay supine, color improved and symptoms resolved. Declined calling MERT or 911 unless she had a change in her condition. Moved to sitting position, tolerated well asymptomatic. Stood became symptomatic, returned to sitting upright in chair. Continued dizziness, pale and nausea, A&O x3. Agreed to be seen in ER, departed in wheel chair with RN (Adult ER) to be evaluated. Time B/P Pulse Resp Position Notes 10:55 98/59 59 16 Sitting/Chair Pale, cool extremities, vertigo; additional monitoring 11:00 89/56 66 14 Sitting/Chair Pale, vertigo- moved to supine position 11:05 98/65 60 12 Supine Symptoms improving 11:12 103/70 76 16 Sitting Symptoms resolved 11:18 Sitting Stand, symptoms returned- changed to sitting to w/c Departed Vaccine Clinic area at 11:20 A&O x3, pale, intermittent dizziness in wheel chair to Adult ER. Charge Nurse notified.",Not Reported,,Not Reported,Yes,,Not Reported,,12/21/2020,12/21/2020,0.0,UNK,,,none,,,"['Capillary nail refill test abnormal', 'Dizziness', 'Hyperhidrosis', 'Nausea', 'Pallor', 'Peripheral coldness', 'Pulse abnormal', 'Vertigo']",UNK,PFIZER\BIONTECH,SC 962035,PA,,U,"hearing loss; zoster-related conditions; Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-JAN-2015, the patient was vaccinated with zoster vaccine live(ZOSTAVAX), for the long-term prevention of shingles and zoster-related conditions (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date, the patient experienced hearing loss and other zoster-related conditions. On an unknown date, the patient was treated by a health care provider for hearing loss and other zoster-related conditions. As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization (on unspecified dates), physician care, monitoring, treatment, medications, and supplies. At the time of report, the patient was not recovered from hearing loss and other zoster-related conditions. The reporter considered the adverse events to be related to Zoster Vaccine Live(ZOSTAVAX). Upon internal review, the hearing loss was considered as medically significant event.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/01/2015,,,PHM,,,,,,['Deafness'],UNK,MERCK & CO. INC., 962036,FL,,M,"idiosyncratic myocarditis; This spontaneous report was received from a pharmacist on behalf of his son, a 19 year old male patient. the patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date (also reported as ""in the past""), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (additional dosage regimen information was not reported). On an unknown date (also reported as ""within 3 weeks of GARDASIL 9""), the patient had pain in the chest. Then, he was admitted to ICU for 4 days and was diagnosed with myocarditis. It was mentioned that the physicians could not pinpoint what virus could have be lead to myocarditis, but it was diagnosed as idiosyncratic. Due to unknown reasons. The patient was under care of an immunologist for unknown reasons and would have an unknown lab work done for immunology related reasons. At the time of the report, the outcome of myocarditis was unknown. No causality assessment was provided. Upon internal review, myocarditis was considered to be medically significant.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,,,,UNK,,,,,,"['Chest pain', 'Intensive care', 'Myocarditis']",UNK,MERCK & CO. INC., 962045,NC,91.0,M,erythematous rash on face and chest. no itching or any other symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/21/2021,1.0,UNK,None,None,None,,NKDA,['Rash erythematous'],UNK,UNKNOWN MANUFACTURER, 962091,NY,,F,"I became aware that my sister was exposed to and tested positive for COVID (I assume at work as she is a nurse) after she had received the initial dose of the COVID-19 Pfizer vaccine; I became aware that my sister was exposed to and tested positive for COVID (I assume at work as she is a nurse) after she had received the initial dose of the COVID-19 Pfizer vaccine; This is a spontaneous report from a contactable consumer. A 32-year-old female patient received first single dose of BNT162B2 (Manufacturer: Pfizer, solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for COVID -19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant. Patient had no prior COVID vaccination. The reporter became aware that her sister was exposed to and tested positive for COVID (she assumed at work as she was a nurse) on Jan2021 after she had received the initial dose of the COVID-19 Pfizer vaccine. She was not sure when the exposure took place, but it had been about 3 weeks since she received the first dose. Patient was tested post vaccination. The outcome of events was recovering. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,01/01/2021,,UNK,,,,,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 962093,NC,44.0,F,"approx 34 hours after vaccine awoke unable to breath. symptoms consistent with laryngospasm. symptoms lasted approx 2 minutes; approx 34 hours after vaccine awoke unable to breath. symptoms consistent with laryngospasm. symptoms lasted approx 2 minutes; This is a spontaneous report from a contactable other healthcare professional. A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot ek9231) on 08Jan2021 03.00 pm intramuscular in the left arm for COVID-19 immunization. Medical history included RA, spondylitis, GERD, known allergies to sulfa, penicillin, cefalexin monohydrate (KEFLEX), sulfamethoxazole, trimethoprim (BACTRIM), adalimumab (HUMIRA), ankylosis. Concomitant medications included acetylsalicylic acid (ASPIRIN), omeprazole, loratadine (CLARITIN) and infliximab (RENFLEXIS). First dose of BNT162B2 was administered on 21Dec2020 11:00 am (lot ek5730) intramuscular in the left arm for COVID-19 immunization. Approx 34 hours after vaccine (also reported as 03Jan2021) awoke unable to breath. Symptoms consistent with laryngospasm, symptoms lasted approx 2 minutes. No treatment provided. No COVID test performed prior or after vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of unable to breath/ Laryngospasm cannot be excluded, considering the plausible temporal relationship. Severe allergic reaction is the known risk for the product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of allergic reaction to vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/01/2021,,PVT,ASPIRIN [ACETYLSALICYLIC ACID]; ; CLARITIN [LORATADINE]; RENFLEXIS [INFLIXIMAB],,Medical History/Concurrent Conditions: Ankylosis; GERD; Penicillin allergy; RA; Spondylitis; Sulfonamide allergy,,,"['Dyspnoea', 'Laryngospasm']",2,PFIZER\BIONTECH,OT 962094,CA,61.0,M,"tested positive on 06Jan2021/Came positive for COVID; I am concerned because I am positive; tested positive on 06Jan2021/Came positive for COVID; I am concerned because I am positive; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date Mar2021), via an unspecified route of administration on 28Dec2020 at a single dose for covid-19 immunization. Medical history included diabetes. There were no concomitant medications. The patient got the vaccination on 28Dec2020. He have been testing every day. The patient got a tested on Sunday, 03Jan2021 and was negative. He was negative on Monday, 04Jan2021 different Company. He went back on Tuesday, 05Jan2021, different Company and was negative. On Wednesday, 06Jan2021, he was tested positive, then on Thursday, 07Jan2021, he was tested negative. He wanted to know if he can continue to get the second vaccination shot 18Jan2021 or not?. The patient did not received any treatment for the event and he just stayed at home. The patient had a lab work last Sep2020. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/06/2021,9.0,UNK,,,Medical History/Concurrent Conditions: Diabetes,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 962095,CA,36.0,M,"contracted COVID after the first dose; contracted COVID after the first dose; This is a spontaneous report from a contactable nurse (patient). A 36-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 vaccine. Medical history and concomitant medications were not reported. It was reported that the patient contracted COVID after the first dose on an unspecified date. He has question about the second dose. He had his first dose on 22Dec2020. He contracted COVID in-between doses. His second dose was due today. He wanted to know if he should receive it today or what was the safety issue. He asked if was it safe to get the second dose of his COVID vaccine if he had COVID? Lab data included COVID-19 positive on an unspecified date. The outcome of 'contracted COVID after the first dose' was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 962117,,,F,"COVID-19; COVID-19; This is a spontaneous report from a contactable pharmacist (reporting for herself). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), via an unspecified route of administration in the left arm on 22Dec2020 at a single dose for COVID-19 immunization. There was no medical history and no concomitant medications. The patient experienced COVID-19 on 28Dec2020, which was reported as being medically significant. The patient underwent lab tests and procedures which included nasal swab test: positive on 29Dec2020. Therapeutic measures were taken as a result of the event and included treatment with bamlanivimab on 30Dec2020. The outcome of COVID-19 was recovered on 07Jan2021. The causality was reported as no (unrelated); Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/28/2020,6.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'Viral test positive']",1,PFIZER\BIONTECH, 962123,,,F,"positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable nurse (patient) received via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose then tested positive for the COVID-19 virus, on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive. The patient outcome of the event was unknown. The information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and suspected LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 962131,,,F,"fever and malaise 1st couple of days after her COVID vaccine.; fever and malaise 1st couple of days after her COVID vaccine.; On day 3-10, experienced 'paresthesia felt like polyneuropathy in hand, right foot, muscles, felt like shooting electric shocks in both hands. It felt like she had been applying 'pressure on nerves'; On day 3-10, experienced 'paresthesia felt like polyneuropathy in hand, right foot, muscles, felt like shooting electric shocks in both hands. It felt like she had been applying 'pressure on nerves'; This is a spontaneous report from a contactable Physician reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included COVID-19 from Feb2020. The patient's concomitant medications were not reported. The patient reported fever and malaise 1st couple of days after her COVID vaccine. On day 3-10, she experienced 'paresthesia, felt like polyneuropathy in her hand, right foot, muscles, felt like shooting electric shocks in both hands. It felt like she had been applying 'pressure on nerves'. Has since resolved completely. She has seen a neurologist who performed a general physical exam and it appeared normal. Also, she notified or asked Nursing occupational health. She had a history of COVID last Feb2020. She was asking if there are any recommendation if she should get the 2nd dose of the COVID vaccine. The events had resolved. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event polyneuropathy cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Discomfort', 'Malaise', 'Neurological examination normal', 'Paraesthesia', 'Polyneuropathy', 'Pyrexia']",UNK,PFIZER\BIONTECH, 962140,WA,36.0,F,"treated as panic attack; having difficulty getting thoughts together; My arms were very numb and tingly; My arms were very numb and tingly; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EK5730, unknown lot number), via an unspecified route of administration in left arm on 30Dec2020 at 09:30 at a single dose for COVID-19 immunization. Medical history included prior history of panic attacks, HPV, and known allergies to pets and pollen. Concomitant medications included naproxen sodium (ALEVE), cyclobenzaprine, and aspirin. The patient was vaccinated in a hospital on 30Dec2020 at 09:30. The early morning of 06Jan2021 at 03:15 AM, the patient woke up with very alarming symptoms. She woke up very suddenly and was having difficulty getting thoughts together, her arms were very numb and tingly. She has had panic attacks before, and this did not feel like anything she had experienced. The events resulted in emergency room (ER)/department or urgent care visit. In ER, the patient treated as panic attack, no testing done. The patient was treated for the events. The patient did not have COVID prior to vaccination and the patient was not tested for COVID post vaccination. The patient did not have other vaccine in four weeks. The patient recovered from the events in Jan2021. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/06/2021,7.0,PVT,ALEVE; ; ASPIRIN [ACETYLSALICYLIC ACID],,Medical History/Concurrent Conditions: Allergy to animal; Human papilloma virus infection; Panic attacks; Pollen allergy,,,"['Condition aggravated', 'Hypoaesthesia', 'Panic attack', 'Paraesthesia', 'Sleep disorder', 'Thinking abnormal']",1,PFIZER\BIONTECH, 962144,,,F,"10 days after receiving vaccine patient tested positive for covid via nasal swab; 10 days after receiving vaccine patient tested positive for covid via nasal swab; Mild cold symptoms; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received her first dose of BNT162B2 (lot no. and expiry date were not reported), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of vaccine, and 10 days after receiving vaccine patient tested positive for covid via nasal swab on unspecified date. The patient also experienced mild cold symptoms on unspecified date. The physician would like to know if his patient should receive second dose or if any literature supports second dose after getting covid in between dose. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Nasopharyngitis', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 962164,IN,63.0,F,"Bells Palsy; This is a spontaneous report from a contactable Other HCP (patient). A 63-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EL1284) intramuscular at single dose at left arm on 29Dec2020 16:30 for Covid-19 immunisation, administered at hospital. Medical history included hypertension, thyroid disorder, high cholesterol, fibromyalgia, allergy to sulfur drugs and codeine. The patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. The patient previously took codeine and experienced drug hypersensitivity. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient experienced bells palsy on 11Jan2021. The event resulted in Emergency room/department or urgent care. The event bells palsy has been treated with steroids. Post vaccination, the patient has been not tested for COVID-19. The outcome of event was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bells palsy cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/11/2021,13.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure high; Fibromyalgia; High cholesterol; Thyroid disorder,,,['Facial paralysis'],1,PFIZER\BIONTECH,OT 962165,PA,56.0,M,"Felt brain fatigue; Felt very hungry before dinner; On 07Jan, after breakfast I suddenly felt tired, so took a nap; During the whole day I took three naps; Had sore arm; Between 15-30 min after injection, I felt light arrhythmia twice and I tried to do deeper breath to control it. About 1.5 hours after injection, in between my pull-up exercises I felt light arrhythmia; his legs were shaking which had never happened before; This is a spontaneous report from a contactable consumer reporting for himself. A 56-years-old male patient received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine , in the right arm on 05Jan2021 16:00 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced light arrhythmia on 05Jan2021 16:30 with outcome of recovered , his legs were shaking which had never happened before on 05Jan2021 with outcome of unknown, had sore arm on 06Jan2021 with outcome of recovered; felt brain fatigue on 07Jan2021 with outcome of recovered , , felt very hungry before dinner on 07Jan2021 with outcome of recovered , on 07Jan, after breakfast felt tired, so took a nap on 07Jan2021 with outcome of recovered , during the whole day i took three naps on 07Jan2021 with outcome of recovered. Course of the event: Between 15-30 min after injection, the patient felt light arrhythmia twice and tried to do deeper breath to control it. About 1.5 hours after injection, in between his pull-up exercises he felt light arrhythmia 2-3 times, and after doing the third set of pull-ups his legs were shaking which had never happened before. Next morning the patient woke up a couple hours later than his normal time. Noting that the night before he went to bed one hour earlier for no reason. When semi-waking up, he had a strong arrhythmia, followed by a couple more light ones. In the past arrhythmia did occur to him when he was very stressed or very tired, but had not have it for a few years. The patient had sore arm but tolerable. On 07Jan2021, after breakfast the patient suddenly felt tired, so took a nap. During the whole day he took three naps, which he had never done before. No arrhythmia though. The patient felt brain fatigue, but physically no problem. He felt very hungry before dinner, same as the day before, but not in other days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Arrhythmia', 'Condition aggravated', 'Fatigue', 'Hunger', 'Mental fatigue', 'Pain in extremity', 'Somnolence', 'Tremor']",1,PFIZER\BIONTECH, 962167,NY,59.0,F,"she tested positive for the covid virus; she tested positive for the covid virus; her arm barely hurt (injection site); This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration in the arm on 02Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received her first Pfizer covid vaccine dose on 02Jan2021. She gets tested regularly at work. On 04Jan2021, she tested positive for the Covid virus. She had a headache, not feeling great on Friday, after she was diagnosed with the Covid virus, but no symptoms before. No side effects from vaccine, other than her arm barely hurt (injection site) in Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'Feeling abnormal', 'Headache', 'Pain in extremity', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 962169,,,M,"Clotting event; Fibrin D dimer high; chest pains; Little injection site soreness; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer -BioNTech), via an unspecified route of administration in the arm, on 22Dec2020, at single dose, for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. The patient experienced fibrin d dimer high in Jan2021 with outcome of unknown, clotting event on 03Jan2021 with outcome of unknown, chest pains on 03Jan2021 with outcome of unknown, little injection site soreness on 22Dec2020 with outcome of unknown. The events fibrin D dimer high and clotting event caused patient's hospitalization in Jan2021. The patient underwent lab tests and procedures which included fibrin d dimer: high in Jan2021. The patient was vaccinated on 22Dec2020 close to the evening and had a normal response with a little soreness in the arm at the injection site. Then on 03Jan2021, he reported to be having chest pains that he never had before and went to the emergency department (ED) due to a clotting event. Upon blood work, they discovered that his D-dimer was elevated and was really high for his age. He mentioned that he had no history and no issues with this whatsoever before. He received the 2nd dose on 11Jan2021. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,12/22/2020,12/22/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chest pain', 'Coagulopathy', 'Fibrin D dimer increased', 'Injection site pain']",1,PFIZER\BIONTECH, 962179,AL,78.0,M,"bleeding from the penis; This is a spontaneous report from a contactable Nurse. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EL0142, via an unspecified route of administration in left arm on 05Jan2021 at single dose for covid-19 immunisation. Medical history included fracture displacement on 23Dec2020, atrial fibrillation, non-hodgkin's lymphoma, post surgical ortho care, semen bleeding, from an unknown date and unknown if ongoing, Covid positive on 06Nov2020 (he was Covid positive before and didn't want to get it again and give it to his wife). There were no concomitant medications. The patient underwent lab tests and procedures which included Covid test positive on 06Nov2020. The patient experienced bleeding from the penis on an unspecified date with outcome of unknown. Nurse wanted to know if there is information about interactions between blood thinners and the vaccine.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event penile haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. Of note, semen bleeding was reported as medical history and no concomitant medications were reported; hence, the role of other possible medical conditions or medications cannot be ruled out. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,,,UNK,,,Medical History/Concurrent Conditions: Atrial fibrillation; Bloody semen; COVID-19 virus test positive; Fracture displacement; Hypertension; Non-Hodgkin's lymphoma; Orthosis user (post surgical ortho care),,,"['Condition aggravated', 'Penile haemorrhage']",1,PFIZER\BIONTECH, 962181,CA,63.0,M,"rash; developed symptoms of covid on 27Dec / on 30Dec2020 he tested positive for the virus / cough; developed symptoms of covid on 27Dec / on 30Dec2020 he tested positive for the virus / cough; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the 1st does of bnt162b2 (BNT162B2) at single dose left upper arm on 23Dec2020 for Covid-19 immunisation, administered at hospital. Medical history included ongoing hypertension that began maybe 10 years before and still ongoing, controlled with medication. No family medical history relevant to the events. The concomitant medications included paracetamol (TYLENOL). History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines administered on same date of the suspect. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. He has not had reactions to any other vaccines. On 30Dec2020 he tested positive for Covid. His symptoms of covid started 27Dec2020 in the evening sometime probably around 7pm. He experienced cough in Dec2020. No visit to physician office was required. On the 06Jan2021 he went to the emergency room but that was because he was concerned about rash he developed. He thought it was due to the Tylenol he was taking. Relevant tests performed in Ja2021 included: blood work and chest X-ray did when he went in for the rash and they were was fine. He was treated with steroid injection for the rash. The rash cleared up in the next couple days. As of 12Jan2021 the only thing he has cough but he coughs anyway. He still had a cough but it was not atypical for him to have a cough. He was scheduled to receive his second dose on 13Jan2021. He no longer had any Covid symptoms and wanted to know if he could still get the second dose as scheduled. The outcome of event tested positive for the virus and not recovered was unknown, of coughs was not recovered. A Product Complaint was filed. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/01/2020,,PVT,TYLENOL,"Hypertension (began maybe 10 years before, still ongoing, controlled with medication)",,,,"['Blood test normal', 'Chest X-ray normal', 'Cough', 'Rash', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 962182,TN,47.0,M,"nausea; vomiting; Mild headache; arm was hurting/Left arm soreness; This is a spontaneous report from a contactable physician reporting for himself. A 47-years-old male patient received the second dose of bnt162b2 (BNT162B2; Lot # EJ1686) vaccine , intramuscular in the left deltoid on 07Jan2021 11:00 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. Previously on 17Dec2020 the patient received the first dose of BNT162B2 vaccine. The patient experienced nausea and vomiting on 10Jan2021 23:59 with outcome of recovered , mild headache on 07Jan2021 20:30 with outcome of recovered , arm was hurting/left arm soreness on 07Jan2021 20:30 with outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 20Nov2020. Nausea and vomiting were considered Important Medical Events.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events nausea and vomiting cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Headache', 'Nausea', 'Pain in extremity', 'Vomiting']",2,PFIZER\BIONTECH,OT 962184,CA,41.0,F,"Really bad headache; Really itchy/itching in her upper body and in legs, like a rash; Rash/itching in her upper body and in legs, like a rash; Mottled skin; This is a spontaneous report from a contactable nurse reporting for herself A 41-years-old female patient received bnt162b2 (BNT162B2; Lot #EL3249) vaccine , in the left arm on 11Jan2021 13:00 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient experienced really bad headache on 12Jan2021 with outcome of unknown , really itchy/itching in her upper body and in legs, like a rash on 12Jan2021 with outcome of unknown , mottled skin on 12Jan2021 with outcome of unknown. Unknown treatment was given for really bad headache The reported events were considered Important Medical Events.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events headache, pruritus, rash and livedo reticularis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/12/2021,1.0,PVT,,,,,,"['Headache', 'Livedo reticularis', 'Pruritus', 'Rash']",2,PFIZER\BIONTECH, 962186,,,F,"tested positive after 1st dose; tested positive after 1st dose; This is a spontaneous report from a contactable Nurse. This nurse reported similar events for 2 patients. This is the second of two reports. This Nurse reported for a 65-year-old female patient (Mother) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at single dose for covid-19 immunization. There was no medical history and no concomitant medications. Mother received 1st dose on 22Dec2020, tested positive for covid-19 infection after 1st dose. Outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Covid-19 virus test positive and suspected LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2021015122 same reporter/drug/AE, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 962189,MO,25.0,F,"Loss of consciousness; Muscle aches; Headache; Nausea; Vomiting; Dose1 26Dec2020, dose 2 12Jan2021; Dose1 26Dec2020, dose 2 12Jan2021; This is a spontaneous report from a contactable nurse. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the right arm second dose on 12Jan2021 12:15 at a single dose (lot number: EK4176) and intramuscular on the right arm first dose on 26Dec2020 10:15 at a single dose (lot number: EL1284) for COVID-19 immunisation. Medical history included asthma. Concomitant medication included Women's multivitamin within two weeks of vaccination. The patient had no allergies to medications, food, or other products; was not diagnosed with COVID-19 prior to vaccination, did not receive any other vaccines within four weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered at a hospital facility. On 13Jan2021 03:30, the patient experienced muscle aches, headache, nausea, vomiting and loss of consciousness. Treatment was not received for the events. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Asthma,,,"['Headache', 'Loss of consciousness', 'Myalgia', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,OT 962192,OH,,M,"The patient that contracted COVID, 19 days after the first dose; The patient that contracted COVID, 19 days after the first dose; This is a spontaneous report from a Pfizer-sponsored program from a contactable physician reporter for himself. A male patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient that contracted COVID 19 days after the first dose and want to know what guidance offer for that situation. The outcome of the event was unknown. Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Covid-19 and suspected LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 962197,AZ,56.0,M,"allergy; I have had additional swelling around my upper body including my right eye and right upper quadrant, right ribs.; I have had additional swelling around my upper body including my right eye and right upper quadrant, right ribs.; I have had additional swelling around my upper body including my right eye and right upper quadrant, right ribs.; my Tongue started swelling; both hands started swelling; Foot swelling including the ankle; Foot swelling including the ankle; This is a spontaneous report from a contactable other hcp reported for himself. A 56-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: bh9899), intramuscular on 31Dec2020 13:30 in left arm at single dose (first dose) for COVID-19 immunization. There were no concomitant medications and medical history. After a day of the vaccine which was giving on Thursday 31Dec2020, patient started experiencing sided effects of his foot swelling including the ankle. On Sunday (03Jan2021), both hands started swelling, Monday (04Jan2021) morning his tongue started swelling and went to his doctor. He administered a steroid and prescribed an Epinephrine pen just in case it got worse and was also prescribed additional medicines for his allergy. Since he had had additional swelling around his upper body including his right eye and right upper quadrant, right ribs. AE treatment including steroid injection, hydroxyzine HCL 25 mg, Methylprednisolone 4 mg. AE resulted in doctor or other healthcare professional office/clinic visit. No other vaccine in four weeks and no other medications in two weeks. There was no COVID tested post vaccination and COVID prior vaccination. The outcomes of events were resolved with sequel.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Abdominal distension', 'Eye swelling', 'Hypersensitivity', 'Joint swelling', 'Peripheral swelling', 'Swollen tongue']",1,PFIZER\BIONTECH,OT 962204,WI,,F,"shortness of breath (SOB) with hyperventilation; shortness of breath (SOB) with hyperventilation; Lightheaded; red blotching on face and neck; appeared shaky; This is a spontaneous report from a contactable pharmacist. An adult female patient (pregnant unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 for first dose at single dose (lot number: EL1283) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced lightheaded, shortness of breath (SOB) with hyperventilation on 08Jan2021. She was laying on the floor and appeared shaky with red blotching on face and neck on 08Jan2021. Medical response called. Anaphylaxis medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to emergency room (ER). Patient also received Diphenhydramine and Famotidine. The events resulted in emergency room/department or urgent care. It was unknown if covid prior vaccination and if covid tested post vaccination. The outcome of the events was recovered in Jan2021.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162b2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Dizziness', 'Dyspnoea', 'Hyperventilation', 'Rash', 'Rash macular', 'Tremor']",1,PFIZER\BIONTECH, 962222,,39.0,F,"Hearing loss; This is a spontaneous report from a contactable Nurse Anesthetist (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL0140) on 18Dec2020 at single dose in the left deltoid for COVID-19 immunization.Medical history included ongoing anaemia. There were no concomitant medications. On 06Jan2021 at 16:00 the patient experienced hearing loss, serious as medically significant. Patient had no problems with her ears before hand. On 06Jan2021 around 4 PM, she was just walking in the store, with no loud music or anything, and all of a sudden her hearing in her left ear went lost and muffled. On 07Jan2021 she went to the Otolaryngologist (ENT doctor) to get her ears checked. They said no it looked perfectly fine. They did an audiogram and hearing test on 07Jan2021 and there was a 20% hearing loss. She had no idea what it was from. She took no other medications. She had anemia but that was it. She was wondering if hearing loss has been reported with the vaccine either in the studies or recently. She researched it, and with the COVID virus itself, back in Jul2020 and Oct2020, people reported hearing loss. So she went and had a COVID test in Jan2021 and it was negative. Patient stated it was very scary and weird. Event treatment included high dose oral steroids to see if it can be treated and the ENT doctor was also giving her steroid shots in the ear. She was due to see him again in Jan2021. The outcome of the event Hearing loss was not recovered. Patient also clarified that she did continue with her second dose of the vaccine on 08Jan2021. She had asked the ENT doctor his opinions on still getting the second dose, and he recommended it. The second dose of the vaccine was given on 08Jan2021 (lot EL3302, EXP: May2021) at single dose in the left deltoid for COVID-19 immunization.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported hearing loss cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,01/06/2021,19.0,UNK,,Anaemia,,,,"['Acoustic stimulation tests abnormal', 'Audiogram abnormal', 'Deafness unilateral', 'Fear', 'Hypoacusis', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 962224,,,U,"got vaccinated for the Covid-19 Vaccine but tested positive after that; got vaccinated for the Covid-19 Vaccine but tested positive after that; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that someone she knew who got vaccinated for the Covid-19 Vaccine but tested positive after that. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 962272,TX,45.0,F,"Short of breath; Chest pain; Heart above 120s; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2), intramuscular on 18Dec2020 at 20:00 at a single dose at the left arm in the hospital for covid-19 immunization. Medical history included hypertension. Patient was not pregnant at time of report. The patient previously took excedrin [acetylsalicylic acid;caffeine;paracetamol;salicylamide] and experienced allergies. Concomitant medication included Tejocote root. The patient experienced heart above 120s, short of breath, fatigue, and chest pain, all on 21Dec2020 at 13:00. Patient went to a doctor or other healthcare professional office/clinic visit for the events. The patient received treatment which included Tylenol as needed for the events. Tested for Covid twice since the vaccination; Covid test post vaccination - Nasal Swab on 30Dec2020 and on unknown date, both with negative results. Cardiologist consult was pending. Outcome of the events was reported as not recovered. Information on the lot/batch number has been requested.; Sender's Comments: The 45-year-old female patient had medical history included hypertension, and was on concomitant medication. The reported events short of breath and chest pain were more likely due to underlying disease, and less likely causally related to first dose of bnt162b2 (BNT162B2). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/21/2020,3.0,PVT,,,Medical History/Concurrent Conditions: Hypertension,,,"['Chest pain', 'Dyspnoea', 'Fatigue', 'Heart rate increased', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,OT 962275,OH,,M,"tested positive with the covid-19 after getting the first dose; tested positive with the covid-19 after getting the first dose; This is a spontaneous report from a contactable consumer reporting for himself from a Pfizer sponsored program, Pfizer First Connect. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, on Jan2021, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient experienced cough, runny nose and tested positive with the covid-19 after getting the first dose of the covid-19 in Jan2021. He asked if he should still get the second dose three weeks after the first one. Information on the lot/batch number was requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['Cough', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 962294,AL,35.0,F,"Acute liver injury; This is a spontaneous report from a contactable physician. A 35-year-old female non-pregnant patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) intramuscularly, in the right arm, at single dose, on 04Jan2021 at 11:00 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included hypertension and drug hypersensitivity to amoxicillin; clavulanic acid (AUGMENTIN). Concomitant medications included labetalol; ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) and cetirizine hydrochloride (ZYRTEC). On 10Jan2021, at 12:00 AM, the patient experienced acute liver injury and hospitalization was required (duration of hospitalization: 1 day). Treatment was received (supportive care for acute liver injury). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (Nasal Swab) on 17Jan2021. Covid test result: negative. The adverse event was assessed as serious (Hospitalization, Life threatening illness). Clinical outcome of the adverse event was unknown at time of this report. Information on Lot/Batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Yes,Yes,1.0,Not Reported,U,01/04/2021,01/10/2021,6.0,OTH,; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Hypertension,,,"['Liver injury', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,OT 962307,SD,93.0,M,"tired; legs felt heavy; stopped breathing; This is a spontaneous report from a Pfizer-sponsored program a non-contactable consumer. A 93-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 11:00 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received vaccine around 11:00 a.m. About two hours later, he said he was tired and couldn't continue with the physical therapy he was doing. He was taken back to his room, where he said his legs felt heavy. Soon after, he stopped breathing. A nurse declared a do-not-resuscitate order. The patient died on 04Jan2021. It was not reported if an autopsy was performed. Outcome of stopped breathing was fatal. Outcome of tired and legs felt heavy was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: stopped breathing",Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Death', 'Fatigue', 'Limb discomfort', 'Respiratory arrest']",UNK,PFIZER\BIONTECH, 962308,UT,,F,"died; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that an 83-year-old female patient (reporter mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included hospice care and dementia. The patient's concomitant medications were not reported. The patient died one day after getting vaccine. She was reportedly in good health the day before receiving vaccine. She was on hospice, frail, but in good condition and checked by a hospice nurse the day before which she reported her in good health considering. She was with dementia but stable in her health. The reporter read investigating 23 deaths of people receiving vaccine in similar conditions. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: died",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,"Medical History/Concurrent Conditions: Dementia; Hospice care (on hospice, frail, but in good condition)",,,['Death'],UNK,PFIZER\BIONTECH, 962310,,,U,"rheumatoid arthritis; inflammation; pain in joints; allergic reaction to flu vaacine; Initial information was received on 12-Jan-2021 regarding an unsolicited valid serious case from consumer/ non-health care professional. This case involves a patient of unknown age who experienced rheumatoid arthritis, allergic reaction to flu vaccine (hypersensitivity), inflammation and pain in joints (arthralgia), while the patient received INFLUENZA VACCINE. Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date were not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient experienced rheumatoid arthritis with inflammation and pain in joints (arthralgia) and allergic reaction to flu vaccine (hypersensitivity) (latency: unknown) following administration of INFLUENZA VACCINE. The events rheumatoid arthritis, inflammation and arthralgia were assessed as medically significant. No laboratory data was reported. The patient was taking XELJANZ XR (TOFACITINIB CITRATE) 11 mg once daily via oral route for rheumatoid arthritis since AUG-2020. It was not reported if the patient received any corrective treatment for hypersensitivity. On an unknown date, the patient recovered from inflammation and arthralgia (reported as symptoms of rheumatoid arthritis, inflammation and arthralgia finally resolved). At the time of report, outcome of rheumatoid arthritis and hypersensitivity were unknown. Information on the batch number was requested.; Sender's Comments: This case concerns a patient of unknown age who had rheumatoid arthritis, allergic reaction, inflammation and pain in joints after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset was unknown. However, patient's laboratory data, concomitant medications ruling out alternate etiologies were not reported. Based upon the reported information, the role of an individual vaccine cannot be assessed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Arthralgia', 'Arthritis', 'Rheumatoid arthritis']",UNK,UNKNOWN MANUFACTURER,OT 962318,KY,80.0,M,"Called to schedule second vaccine and daughter reports that he died on01/19/2021 with ""COVID""",Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/19/2021,21.0,OTH,Unknown,unknown,unknown,,unknown,"['COVID-19', 'Death']",1,MODERNA,IM 962325,VA,80.0,M,"Patient's wife called this morning stating that her husband has passed away last night. After receiving first dose of Pfizer COVID-19 vaccine at around 0830, patient remained in the Immunizations Department for the 15-minute monitoring period. Per wife, patient's only complaint was pain at the injection site. At 1300, wife states that patient complaint of dizziness which ""dissipated after a few minutes"" followed by a headache which ""dissipated after a few minutes"" as well. Then patient complained of nausea, no vomiting and ""couldn't relax."" Per wife, from around 1400/1500, patient stayed on his recliner while still having a conversation with her--""he didn't get up to eat."" Last conversation they had was around 2000/2100. Per wife, at around 2100/2200, patient was quiet and when she checked on him, ""he wasn't responding anymore."" Wife then called 911, ""but they couldn't revive him.""",Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,,01/20/2021,01/20/2021,0.0,MIL,,,,,,"['Anxiety', 'Death', 'Dizziness', 'Headache', 'Injection site pain', 'Nausea', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 962355,KY,66.0,F,"Patient presented with worsening fatigue and shortness of air that began Friday(1/15/21) after receiving COVID 19 vaccination. She has also had nausea, vomiting, and diffuse abdominal pain since that time. Patient has had a cough for last five days. Patient admitted to ICU for care on 1/17/2021.",Not Reported,,Not Reported,Yes,,Not Reported,,01/13/2021,01/17/2021,4.0,SEN,,COVID positive 12/18/2020,"Hypertension, diabetes, depression",,,"['Abdominal pain', 'Cough', 'Dyspnoea', 'Fatigue', 'Intensive care', 'Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 962360,,75.0,M,Admitted to hospital 1/14/21 with Fever; Hypoxia; Pneumonia due to COVID-19 virus; COVID+1/14/21. Discharged home 1/18/21,Not Reported,,Not Reported,Yes,,Not Reported,U,01/12/2021,01/14/2021,2.0,UNK,,,,,AMOXICILLIN-POT CLAVULANATE,"['COVID-19 pneumonia', 'Hypoxia', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA, 962382,,78.0,F,"Admitted to hospital 1/14/2021 with acute mental status changes, hypoxia, pneumonia (previous positive COVID 12/18/2020) ICU 1/14/2021-1/16/2021, currently hospitalized PCU level of care",Not Reported,,Not Reported,Yes,,Not Reported,,01/13/2021,01/14/2021,1.0,SEN,,COVID-19 positive 12/18/2020,Cirrhosis Alcohol use disorder Depression,,NKA,"['Hypoxia', 'Intensive care', 'Mental status changes', 'Pneumonia']",1,PFIZER\BIONTECH,IM 962390,,81.0,M,"Admitted to hospital after vaccination with Acute hypoxemic respiratory failure, Septic shock; Aneurysm of arteriovenous dialysis fistula; expired 1/16/2021",Yes,01/16/2021,Not Reported,Yes,,Not Reported,,01/10/2021,01/10/2021,0.0,UNK,,intestinal adhesions with obstruction; Intestinal adhesions with partial obstruction; S/P colon resection; SBO (small bowel obstruction),"chronic renal failure, stage 5; Dilated cardiomyopathy; end stage renal disease on dialysis; End stage heart failure",,ASPIRIN,"['Arteriovenous fistula aneurysm', 'Death', 'Respiratory failure', 'Septic shock']",1,PFIZER\BIONTECH, 962463,MI,79.0,M,"a history of Parkinson's who presented with generalized weakness as well as urinary frequency. Patient had a history of prior COVID 19 infection�in 10/2020, was hospitalized. He had the first dose of COVID vaccine 1/19 and after that, he developed fever, increasing weakness and was unable to get out of a chair and therefore presented to the ED.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/19/2021,01/20/2021,1.0,PHM,Zyloprim Norvasc aspirin Lipitor Sinemet celexa lovenox miralax K-dur Mirapex,Covid-19 10/31/2020,Coronary artery disease hypercholesterolemia HTN Parkinsons,,None known,"['Asthenia', 'Mobility decreased', 'Pollakiuria', 'Pyrexia']",1,MODERNA,IM 962567,OR,41.0,F,Employee received first dose of Pfizer-BioNTech Covid-19 Vaccine on 12/28/20. Per Employee's manager: Patient began experiencing symptoms of neuropathy and was admitted to the hospital as an inpatient on 1/18/21. Informed from neurologist that most likely Guillain-Barr� syndrome resulted from vaccine and instructed to not receive 2nd dose of vaccine at this time.,Not Reported,,Not Reported,Yes,3.0,Not Reported,N,12/28/2020,01/18/2021,21.0,PVT,Unknown. Hospitalist overseeing inpatient care,Unknown.,Hypothyroidism. Contact Doctor for more information on past medical history.,,Tetracycline,"['Guillain-Barre syndrome', 'Neuropathy peripheral']",1,PFIZER\BIONTECH,IM 962590,OR,67.0,F,"Pt presented to the ER 1/21/21 for a syncopal episode, approximately 36 hours after injection. She reported fatigue and dizziness the evening of 1/20/21, then had a syncopal episode and incontinence of diarrhea at that time. She also had hypotension that was corrected with IVF, lowest BP was 60/45 at 0200 on 1/21/21.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/19/2021,01/20/2021,1.0,PVT,"Fosamax, Atacand, Multivitamin, Tramadol, Valsartan",None,"Asthma, COPD, HTN, hx of breast cancer",,"Azithromycin, Codeine, Hydrocodone, Sulfa Antibiotics- all 4 reported as Anaphylaxis reactions","['Anal incontinence', 'Diarrhoea', 'Dizziness', 'Fall', 'Fatigue', 'Hypotension', 'Laboratory test normal', 'Syncope']",1,MODERNA,IM 962598,MS,77.0,M,"After vaccination, could not sleep , hallucinations, didn't sleep until Friday night which he seemed to get a little better. Tuesday morning, he could not feed or dress himself. Went to see his PCP. He went to hospital for CT Scan. If he worsens, take him to the ER. Has appointment to see his Neurologist on Feb. 4.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/12/2021,01/13/2021,1.0,OTH,"Azathioprine, Meloxicam, Rytary, Rosuvastatin, Tyridostigmine, Quetiatine, Donetezil, Sertraline, Rasagile, Nuplazid, Myrbetriq, Folbee, Tylenol, Omeprazole, Low Dose Aspirin",no,Parkinson's Disease,,Morphine,"['Blood test', 'Chest X-ray', 'Computerised tomogram', 'Hallucination', 'Insomnia', 'Loss of personal independence in daily activities', 'Urine analysis']",1,MODERNA,IM 962678,TX,33.0,F,Developed hydrops of gallbaldder and acute cholecystitis 12 hours after vaccination with no history of gallbladder disease prior to this. I was 26 weeks 5 days pregnant with EDD 04/15/2021,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/12/2021,01/12/2021,0.0,PVT,Prenatal vitamins,None,None,,None,"['Cholecystectomy', 'Cholecystitis acute', 'Cholecystitis infective', 'Cholelithiasis', 'Culture negative', 'Exposure during pregnancy', 'Hydrocholecystis', 'Liver function test normal', 'Pancreatic enzymes normal', 'Ultrasound biliary tract abnormal']",1,MODERNA,IM 962714,AK,80.0,M,We do not believe that the patient's death was an adverse event from the vaccine. Patient received COVID vaccine from Pfizer Dose #1 12/19/2020 (lot # EK5730) and Dose #2 1/7/2021 (lot # EL1284). No side effects or adverse events noted; lived in 24/7 care facility and monitored twice daily for reaction. Patient died 1/10/2021 from chronic respiratory failure and congestive heart failure after recent aspiration pneumonia requiring hospitalization. Death was anticipated and not sudden. We were told to report his death to VAERS even though his death was anticipated and not related to his vaccination.,Yes,01/10/2021,Not Reported,Not Reported,,Not Reported,N,12/19/2020,01/10/2021,22.0,PVT,"Acetaminophen suppository 650mg PRN, atropine 1% opthamlic solution, biotine moisturizing mouth solution, lorazepam concentrate 2mg/ml, milk of magnesia suspension 400mg/5ml, morphine sulfate solution 20mg/ml, zofran ODT tablet 4mg.",Aspiration pneumonia (dx on 12/16/2020),"Congestive heart failure, chronic respiratory failure, dementia, chronic mylomonocytic leukemia, chronic COPD, coronary artery disease, dysphagia.",,"lisinopril, shellfish","['Cardiac failure congestive', 'Chronic respiratory failure', 'Death']",1,PFIZER\BIONTECH,IM 962716,ND,62.0,F,Patient deceased,Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/19/2021,20.0,PHM,"TRAMADOL, CHOLESTYRAMINE, DICOLFENAC SODIUM TOPICAL GEL, GABAPENTIN, TRAZODONE, LEVETIRACETAM, HYDROXYZINE HCL, FUROSEMIDE, DIVALPROEX SODIUM, ELIQUIS, LEVOTHYROXINE",,,,"CEPHALEXIN, CODEINE, PENICILLIN, TETRACYCLINE",['Death'],1,PFIZER\BIONTECH,IM 962722,KS,61.0,M,"Hypoxia, left sided weakness, seizures, transferred to Emergency Room.",Not Reported,,Yes,Yes,3.0,Not Reported,U,01/18/2021,01/19/2021,1.0,SEN,Lisinopril Duloxetine Pepcid synthroid atorvastatin donepezil aspirin theram,COVID-19 (December 5th 2020),Multiple Sclerosis Dementia Neuropathy MajorDepressive Disorder,,NKA,"['Hemiparesis', 'Hypoxia', 'Seizure']",2,PFIZER\BIONTECH,IM 962764,AK,73.0,M,"Patient did not have any adverse reaction to the COVID vaccine, but we were asked by our health dept to submit a VAERS report since the patient died between his first and second dose. Received Pfizer Dose #1 12/17/2020. No side effects or adverse events noted; lived in 24/7 care facility and monitored twice daily for reaction. Date of death 12/23/2020 from aspiration pneumonia complicated by end-stage heart failure and ischemic cardiomyopathy. Death was anticipated and not sudden.",Yes,12/23/2020,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/21/2020,4.0,PVT,"acetaminophen suppository 650mg, polyvinyl alcohol solution 1.4%, atropine 1% ophthalmic solution, fentanyl patch 72hr 50mcg/hr, lorazepam concentrate 2mg/ml, morphine sulfate solution 20mg/ml.","Scrotal edema, aspiration pneumonia","Ischemic cardiomyopathy, congestive heart failure, hypertensive heart disease, type 2 diabetes with diabetic neuropathy, spinal stenosis with neurogenic claudication, chronic kidney disease, atrial fibrillation, COPD, venous insufficiency.",,"lisinopril, seroquel, penicillins, beer","['Cardiac failure chronic', 'Condition aggravated', 'Death', 'Ischaemic cardiomyopathy', 'Pneumonia aspiration']",1,PFIZER\BIONTECH,IM 962765,MN,59.0,M,"3 days after vaccine, second dose given on day 16, developed ascending paresthesia, no weakness, up to abd from LEs and to elbows on BUE",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/07/2021,01/10/2021,3.0,PVT,"Terazosin, Amlodipine/Benazepril, Benadryl, ASA",none,"HTN, elevated lipids, BPH",,none,"['Laboratory test normal', 'Magnetic resonance imaging spinal normal', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 962783,NV,30.0,F,"""history of multiple allergic type reactions in the past is presenting for itching and the feeling of hoarse voice after receiving the first Covid vaccine. Here, she is slightly tachycardic, but her oxygen level is good, her lungs are clear. She has no urticaria, she has no stridor or wheezing. She does not wish to receive epinephrine because she has had such bad effects from it in the past, and is agreeable to Solu-Medrol and Benadryl. She took Pepcid prior to having her injection. Her friend who is with her recommends that she has a history of severe events like this in the past, and she usually does better after breathing treatment. However, patient states that she often ends up on BIPAP"" PER ED MD NOTE",Not Reported,,Not Reported,Yes,,Not Reported,U,01/20/2021,01/20/2021,0.0,PVT,TOOK PEPCID PRIOR TO VACCINE,NONE KNOWN,"PACEMAKER RELATED TO AMI AFTER ""ERRANT DOSE OF EPINEPHRINE"" WAS GIVEN 5Y AGO, PHRENIC NERVE PARALYSIS",,"GABAPENTIN, METOPROLOL, IVABRADINE, MORPHINE, PCN","['Anaphylactic reaction', 'Anxiety', 'Blood lactic acid increased', 'Cough', 'Dyspnoea', 'Full blood count', 'Hypertension', 'Intensive care', 'Leukocytosis', 'Metabolic function test', 'Oxygen saturation decreased', 'Respiratory distress', 'Respiratory rate increased', 'SARS-CoV-2 test negative', 'Tachycardia', 'Throat irritation', 'Wheezing']",1,MODERNA,IM 962784,,88.0,M,"patient expired 1/15/2021; had been treated as outpatient for pneumonia, likely COVID-19 but no positive test result in December 2020. PMH diabetes",Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/15/2021,6.0,UNK,,PNEUMONIA,,,"LATEX, NATURAL RUBBER","['COVID-19', 'Death', 'Pneumonia']",1,PFIZER\BIONTECH, 962827,,93.0,F,"Admitted 1/14/21: Patient is an elderly 93-year-old female with multiple medical problems including chronic combined CHF, P 80, diabetes mellitus, HTN, hyperlipidemia, CKD stage 3, has been complaining of generalized weakness, fatigue, decreased appetite for the past few days. She had an outpatient COVID-19 vaccine earlier today. Within 2 hr of admitting the patient to the hospital, condition clinically deteriorated. Patient elected to be DNR/DNI while in the ED. Patient was pronounced dead at 10:30 p.m. earlier today. Preliminary cause of death: Hypoglycemia induced lactic acidosis.",Yes,01/14/2021,Not Reported,Yes,,Not Reported,,01/14/2021,01/14/2021,0.0,UNK,,,"chronic combined CHF, diabetes mellitus, HTN, hyperlipidemia, CKD stage 3",,ATORVASTATIN; CODEINE; DOXY,"['Asthenia', 'Death', 'Decreased appetite', 'Fatigue', 'General physical health deterioration', 'Hypoglycaemia', 'Lactic acidosis']",1,PFIZER\BIONTECH, 962851,,91.0,F,"presented to the ED 1/5/21 with syncope 1 hour after receiving COVID vaccine found to have acute hypoxic resp failure at rest. Per family patient's pulse ox low with exertion at baseline for the past couple of months, but she always recovers to above 90%. She was discharged home with home health with oxygen 1/19/21",Not Reported,,Not Reported,Yes,,Not Reported,,01/15/2021,01/15/2021,0.0,UNK,,,,,,"['Respiratory failure', 'Syncope']",1,PFIZER\BIONTECH, 962921,CO,38.0,F,I have myalgia and vomitting. I am currently pregnant but am due to take medication this weekend to stimulate cramping. I have had 4 healthy pregnancies without complications.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,UNK,"I take prenatal vitamins, vitamin D & DHA.",No,No,,No,"['Foetal non-stress test abnormal', 'Myalgia', 'Ultrasound scan abnormal', 'Vomiting']",2,PFIZER\BIONTECH, 962940,WI,83.0,M,"Pt received second dose of COVID vaccine on 01/20/2021 at 1430. At 1600 Pt developed a wet productive cough with coarse crackles. Pt ate dinner at 5 pm cough persisted. At 18:30 the nurse went to Pt's room to give him his medications. Pt still had a cough, denied shortness of breath. Pt was in a good mood and joking with staff. Pt asked to be shaved. At 19:45 Pt was sitting in the lounge and a CNA noticed that Pt was pale/white in color and clammy. 02 Sat was 85%. Respirations were labored. Pt was placed on 4 L of 02. Increased to 5 L via face mask and 02 sat was 89-90%. Ambulance was called at unknown time. Pt arrived at Medical Center at 2120 and was pronounced dead at 2127.",Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,SEN,"Acetaminophen, Digoxin, Insulin glargine, Loratadine, Simvastatin, Tamsulosin, Warfarin",Unknown,"Dementia, Diabetes, Chronic A Fib, Dyslipidemia, Depression, Osteoarthritis",,Galantamine,"['Cold sweat', 'Crepitations', 'Death', 'Dyspnoea', 'Pallor', 'Productive cough']",2,MODERNA,IM 962952,OR,29.0,F,Miscarriage,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/11/2021,1.0,WRK,Herbal remedy from acupuncturist,None,None,,Allergy to doxycycline,"['Abortion spontaneous', 'Exposure during pregnancy', 'Human chorionic gonadotropin']",1,MODERNA,IM 962957,IL,88.0,F,Patient became lethargic with labored breathing and decreased oxygen saturation. Expired after sent out of facility for treatment.,Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/18/2021,3.0,SEN,"Atorvastatin, Enalapril maleate, Metoprolol, Maxzide",COVID recovered,"Dementia, HTN, Hyperlipidemia, Edema, Constipation, Dysphagia",,NKDA,"['Death', 'Dyspnoea', 'Lethargy', 'Oxygen saturation decreased']",UNK,UNKNOWN MANUFACTURER,IM 962966,,80.0,F,"On Saturday, 1/16/2021, Patient went to the grocery store. Upon her return, she indicated she was experiencing N/V and some throat swelling. Patient subsequently collapsed and expired before she could be brought to an emergency room. During investigation by Coroners Office, it has been reported that Patient may have gotten some takeout food while she was out. Labs are pending and the Coroners investigation is ongoing. Spouse believes that her death was caused by the vaccine.",Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/16/2021,2.0,UNK,,,"atrial fibrillation, hypertension, and hyperlipidemia",,Codeine,"['Death', 'Laboratory test', 'Nausea', 'Pharyngeal swelling', 'Syncope', 'Vomiting']",1,PFIZER\BIONTECH, 962980,MD,63.0,M,"admitted to shady grove hospital for ITP(immune mediated thrombocytopenia) plts were 1 on admission have not responded to typical ITP therapies, platelets still 4 today after 4 days in hospital workup shows ITP no other risk factors or history of itp or autoimmunity",Not Reported,,Yes,Yes,4.0,Not Reported,N,01/07/2021,01/18/2021,11.0,PUB,rosuvatatin 10mg po daily lisinopril 10mg po daily metformin 750 mg po bid centrum MVI asa 81mg po daily,none,dm htn hyperlipidemia,,penicillin sulfa,"['Full blood count', 'Haemoglobin normal', 'Immune thrombocytopenia', 'Platelet count decreased', 'White blood cell count normal']",1,MODERNA,SYR 962983,,79.0,F,She received her first COVID vaccine 1/15. She tested positive for COVID 1/17 in outpatient clinic. Presented to ED 1/18 with a chief complaint of fatigue. admitted to Hospital Medicine for treatment of COVID-19 viral infection and was treated with supportive care. She was enrolled in the COVID-19 Home Symptom Monitoring program & discharged home 1/20/21,Not Reported,,Not Reported,Yes,,Not Reported,,01/15/2021,01/18/2021,3.0,UNK,,,,,AMOXICILLIN; CIPROFLOXACIN; NITROFURANTOIN MACROCRYSTAL; SULFA (SULFONAMIDE ANTIBIOTICS),"['COVID-19', 'Fatigue', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 962995,CA,61.0,M,"No immediate reaction. Patient-reported deceased four days later on Jan. 19, 2021. As of this date cause of death is unknown to our clinic.",Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/19/2021,4.0,PVT,Unknown,Unknown,Unknown,,No known allergies.,['Death'],1,MODERNA,IM 963003,OR,42.0,F,"Acute Bell's Palsy right side occurring on 1/16/2021, total right sides facial palsy involving eyelid, mouth, decreased salivary secretion, facial, ear, mastoid pain. Started prednisone 60mg daily and Acyclovir 400mg po 5x/day on 1/17/2020 x 1 week course. No improvement since onset.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/28/2020,01/16/2021,19.0,PVT,,,,,,"['Aptyalism', 'Ear pain', 'Facial pain', 'Facial paralysis', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging normal', 'Mastoid disorder']",1,PFIZER\BIONTECH,SYR 963016,PA,65.0,F,unknown. Event occurred after leaving vaccination site,Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/15/2021,1.0,PUB,unknown,denied ill symtpoms at time of vaccination,denied,,unknown. Denied allergies on vaccine form,['Death'],1,MODERNA,IM 963019,NV,39.0,F,"Minor arm swelling & hardness day after vaccine, which resolved. Sx returned and progressively worsened on 1/13/21. Was admitted to hospital on 1/15/21 and remains under treatment.",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,01/06/2021,01/13/2021,7.0,PUB,Unknown,Not known,Not known,,NKDA,"['Induration', 'Peripheral swelling', 'Ultrasound scan normal']",1,MODERNA,IM 963039,,82.0,F,Pt brought to ER 1/11/21 & noted to be hypoxic. Patient has been increasingly fatigued for the past several days but with no fever. COVID+ 1/11/21. Treated with remdisivir and discharged home 1/15/21,Not Reported,,Not Reported,Yes,,Not Reported,Y,01/10/2021,01/11/2021,1.0,UNK,,,,,Tramadol (Generalized pruritus); Atorvastatin (Joint pain/muscle aches); Crestor [rosuvastatin] (Myalgia); Flexeril [cyclobenzaprine] (Itching and Rash); Zocor,"['Fatigue', 'Hypoxia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 963057,,96.0,F,"presented to ED 1/9/21 with abdominal pain, progressive worsening weakness and fatigue and new onset A fib with RVR likely due to hypertensive urgency . Patient progressed clinically with severe hypoxia and transferred to ICU and started on BiPAP; progressive decline with decreased urinary output with uremia likely secondary to sepsis. Concern with patient worsening clinical decline, palliative care had been consulted on end of life care. Patient expired 1/17/21",Yes,01/17/2021,Not Reported,Yes,,Not Reported,,01/09/2021,01/09/2021,0.0,UNK,,,"hypertension, hypothyroidism, emphysema, CKD 3, and history of breast cancer",,,"['Abdominal pain', 'Asthenia', 'Atrial fibrillation', 'Azotaemia', 'Bilevel positive airway pressure', 'Death', 'Fatigue', 'General physical health deterioration', 'Hypertensive urgency', 'Hypoxia', 'Intensive care', 'Sepsis', 'Urine output decreased']",1,PFIZER\BIONTECH, 963090,VA,33.0,F,"Patient experienced lip and tongue swelling within 30 minutes of receiving vaccine. Given 25 mg diphenhydramine with no improvement, began having tightening of throat and worsened tongue swelling. Received 3 total doses of IM epinephrine before admission to hospital. Received another dose of IM epinephrine in the ED in addition to methylprednisolone 125 mg, famotidine, and diphenhydramine. Symptoms resolved, no airway edema observed on laryngoscopy. Admitted to medical ICU for observation overnight. Around 12:00 PM the following day, patient again experienced what she described as tongue swelling and lip tingling. Given another dose of IM epinephrine, dexamethasone 10 mg, famotidine, and diphenhydramine. Symptoms resolved.",Not Reported,,Yes,Yes,,Not Reported,U,01/21/2021,01/21/2021,0.0,PUB,fluoxetine 20 mg daily sertraline 25 mg daily,none,"anxiety, depression",,amoxicillin (hives) tamiflu (hives),"['Intensive care', 'Laryngoscopy normal', 'Lip swelling', 'Paraesthesia oral', 'Swollen tongue', 'Throat tightness']",1,MODERNA,IM 963136,KS,75.0,F,"Patient had COVID diagnosed and treated as outpatient on 12/24. She developed SOB with the infection and this persisted afterwards and did not resolve. She received first dose of Moderna vaccine and next day had fevers, myalgias, shortness of breath and hypoxia. She is now admitted to our facility with bilateral diffuse ground glass opacities and is severly hypoxic on high flow nasal cannula. She also has hemoptysis. procalcitonin is negative; BNP is normal; troponin normal.",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/19/2021,01/20/2021,1.0,PVT,"ASA 81mg, lipitor, teassalon pearls, cardizem, lisinopri-HCTZ, toprol XL, omega 3 fish oil, KCL",COVID diagnosis on 12/24. She was treated as outpatient and had no prior radiographic imaging. She developed shortness of breath at the time of infection that persisted after recovery.,"HTN, HLD, and bronchitis/asthma",,none,"['Blood creatinine normal', 'Blood lactate dehydrogenase increased', 'Blood sodium decreased', 'Brain natriuretic peptide normal', 'Dyspnoea', 'Eosinophil count decreased', 'Fibrin D dimer increased', 'Haemoglobin decreased', 'Haemoptysis', 'Hypoxia', 'Liver function test normal', 'Lung opacity', 'Myalgia', 'Procalcitonin normal', 'Pyrexia', 'SARS-CoV-2 test positive', 'Troponin normal', 'White blood cell count normal']",1,MODERNA,IM 963137,TN,67.0,F,Patient received vaccine and 2 days later suffered a CVA,Not Reported,,Yes,Not Reported,,Not Reported,Y,12/29/2020,12/31/2020,2.0,PVT,,,,,,['Cerebrovascular accident'],1,PFIZER\BIONTECH,IM 963140,AL,20.0,M,"Anaphylactic shock, my throat started to close and couldn?t breathe",Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/18/2021,01/18/2021,0.0,SCH,"Aderall, Omneprazoll",,Asthma,,"Z-pack, Outdoor Allergies","['Anaphylactic reaction', 'Anaphylactic shock', 'Dyspnoea', 'Throat tightness']",1,MODERNA,SYR 963213,CA,30.0,M,"Patient had 4 hours of chest pain 3 days after vaccine. EKG showed STEMI. Troponin elevated at 4.8. Patient sent for cardiac catheterization and results pending. At this time suspect myocarditis, but STEMI not yet excluded",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/18/2021,01/21/2021,3.0,PUB,Daily Multivitamin,No,None,,None,"['Acute myocardial infarction', 'Catheterisation cardiac', 'Chest pain', 'Electrocardiogram ST segment elevation', 'Myocarditis', 'Troponin increased']",1,MODERNA,IM 963225,MI,39.0,F,"I received my second covid 19 vaccine on 1/18/21. I was 7 weeks pregnant at that time. About 14 hours after receiving the injection, I developed a fever of 100.4 accompanied by feeling unwell like I had the flu. Symptoms included local pain at the injection site, chills, malaise, headache, joint pains and fever with temp max of 102.6 at about 26 hours post vaccine. Tylenol 1000mg taken. Then I slept until the next morning. Symptoms improved by 36 hours post vaccine. Afebrile but feeling tired following throughout the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/19/2021,1.0,PVT,Effexor. Prenatal vitamin.,None,None,,None,"['Arthralgia', 'Chills', 'Exposure during pregnancy', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Pregnancy', 'Pyrexia']",2,PFIZER\BIONTECH,IM 963235,TX,94.0,F,"Patient diagnosed with COVID on January 9, 2021 after being exposed to family member that was under quarantine in the same household. Admitted to the hospital and was discharged on January 14, 2021 with home hospice. Patient passed away on January 18, 2021",Yes,01/18/2021,Not Reported,Yes,5.0,Not Reported,N,01/04/2021,01/09/2021,5.0,WRK,"Klonipin, Myrbetriq, Zoloft, Carafate, Isosorbide, Allopurinol, Colace, Calcium Carbonate, Synthroid, Famotidine, Metoprolol, Losartan, Tylenol",,"HTN, Depression, Atherosclerotic heart disease, GERD, Hypothyroidism, Chronic renal failure stage 3, CHF",,Lisinopril,"['COVID-19', 'Death', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test']",1,MODERNA,IM 963243,AZ,78.0,M,had first of his COVID-19 vaccines 1/5/2021 and tested positive for COVID-19 on 1/10/2021,Not Reported,,Not Reported,Yes,,Not Reported,N,01/05/2021,01/10/2021,5.0,PVT,"Levemir, ibuprofen, alogliptin, Refresh Plus, cyanocobalamin, doxazosin, aspirin, cholecalciferol, sildenafil, simvastatin, losartan, metformin",NONE,"asthma, DM, HTN, hyperlipidemia, BPH, OSA, diverticulosis, polymyalgia rheumatica, vitamin D deficiency",,"codeine, lisinopril",['SARS-CoV-2 test positive'],1,MODERNA,IM 963267,CO,44.0,F,"Anaphylaxis, angioedema. Unresponsive to epinepherine, steroids. Patient required intubation, mechanical ventilation, and ICU admission. Patient started on high dose steroids, BID IV famotidine, nebulizer therapy, with improvement in symptoms. Pt still in ICU at time of this submission.",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/20/2021,01/20/2021,0.0,PHM,NONE,NONE,Mild intermittent asthma. Diet controlled diabetes.,,NONE,"['Anaphylactic reaction', 'Angioedema', 'Endotracheal intubation', 'Intensive care', 'Mechanical ventilation']",1,MODERNA,IM 963269,TX,87.0,F,Patient passed away on 01/18/2021,Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/18/2021,14.0,WRK,"Lisinopril, Januvia, Fosamax, Trazodone, Metoprolol, Colace Simvastatin, Levoxyl, Lantus, Zocor",,"Type 2 Diabetes, HTN, DJD, Blindness bilateral, Glaucoma, Dyslipidemia, Diverticulosis, Osteoporosis, Memory loss, Chronic renal failure, CAD",,NKDA,['Death'],1,MODERNA,IM 963274,CO,44.0,F,"Anaphylactic reaction, initially unresponsive to IM epinepherine, IV famotidine, IV steroids. Symptoms worsened, requiring intubation, mechanical ventilation, ICU admission",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/21/2021,01/21/2021,0.0,PHM,NONE,NONE,Mild intermittent asthma. Diet controlled diabetes.,,NONE,"['Anaphylactic reaction', 'Endotracheal intubation', 'Intensive care', 'Mechanical ventilation']",1,MODERNA,IM 963313,MA,62.0,F,"Fevers as high as 105.1F , severe chills, headaches, body aches, nausea, severe fatigue",Not Reported,,Yes,Yes,3.0,Not Reported,N,01/12/2021,01/13/2021,1.0,PVT,"Lyrics, tacrolimus, xaralto, albuteral, magnesium, albuteral, VitD, folic acid, amlodipine, nexium",N/a,"Chronic cough, celiac disease, autoimmune hepatitis",,"PCN, Sulfa meds, phenergan, imuran","['Blood test abnormal', 'Chest X-ray normal', 'Chills', 'Echocardiogram normal', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 963331,ND,76.0,M,"WOKE UP AT 0700 THIS AM WITH BODY ACHES, NAUSEA/VOMITING, CHILLS, DIZZINESS, WEAK, TEMP 102. ADMITTED 1/21/2021 INPATIENT. IV NS @ 100ML/HOUR, ZOFRAN 4MG IV, LOVENOX 40MG, SOLUMEDROL 125MG IV.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/20/2021,01/21/2021,1.0,PVT,NEURONTIN 300MG BID + 900MG AT BEDTIME OXYCODONE 10MG Q 4 HOURS PRN MELATONIN 20MG GUMMIES Q HS VITAMIN D 2000 U DAILY VITAMIN C WHEN HE REMEMBERS,,"RESTLESS LEGS, CHRONIC BACK PAIN, COVID OCTOBER, WAS HOSPITALIZED FOR ONE NIGHT",,CIPRO,"['Asthenia', 'Body temperature increased', 'Chills', 'Dizziness', 'Nausea', 'Pain', 'Vomiting']",UNK,MODERNA,IM 963352,TX,29.0,F,"Heart Palpitations , Nausea , headache, arm hurting No appetite Chest Pain A lot of mild reactions Pulse was over 100",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,Milti Vitamin Daily,na,Migraines,,Penicillin Cynomycin,"['Chest pain', 'Decreased appetite', 'Electrocardiogram T wave abnormal', 'Headache', 'Heart rate increased', 'Nausea', 'Pain in extremity', 'Palpitations']",1,MODERNA,IM 963369,MN,60.0,M,"sx: felt hot, tingling at corners of mouth, dry mouth s: lungs cta b/l, upper airway cta b/l, no uvular swelling, no rash tx: benadryl 50 mg PO x 1, monitoring outcome: 911 called, pt monitored, ambulance cancelled, monitored in clinic, condition improved/resolved, discharged home with epi pen and instructions to call 911 if airway irritation develops.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,PVT,"l-argine, theraflavone, lisinopril, fluticasone nasal spray.","pharyngitis: lab confirmed negative strep, flu and covid.","allergic rhinitis, gerd, htn, hyperlipidemia",,"omeprazole (hives), crestor (headache), erythromycin (diarrhea)","['Dry mouth', 'Feeling hot', 'Paraesthesia oral']",UNK,MODERNA,IM 963383,UT,30.0,F,"Fever of 100.3 x 3 days, systemic hives daily and continues as of today 1/21/21. Used an Epipen over the weekend due to face and mouth swelling. Been to Dr several times since 12/24/20. Prednisone and antihistamines given with minimal relief. Patient has missed several days of work due to systemic swelling and hives covering her entire body.",Not Reported,,Yes,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,OTH,unknown,None,None,,sulfa,"['Impaired work ability', 'Mouth swelling', 'Pyrexia', 'Swelling face', 'Urticaria']",1,MODERNA,IM 963388,ND,88.0,F,Patient died unexpectedly 5 days after receiving vaccine (1/10/2021).,Yes,01/10/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/10/2021,5.0,PVT,"Albuterol, Aspirin, Ativan, Ayr Saline Nasal, Biotene Dry mouth moisturizing spray, docusate sodium, Florajen 3, gabapentin, hydralazine HCL, Hydrocortisone acetate/LI, Isosource VHN 1.5 cal, ketoconazole, Lasix, lopressor, multivitamin, pl",No known illnesses at time of vaccination.,"COPD, Aptyalism, upper respiratory tract infection due to Influenza, acute bronchitis, Pnuemonia, generalized anxiety disorder, impaired intestinal carbohydrate absorption, heart failure, GERD without esophagitis, long term current use of anticoagulant, transplanted skin present, history of UTISs, constipation, Periipheral vascular disease, chronic pain, history of amputation of lower limb above knee, sick sinus syndrome, candidiasis of skin, dysuria, Cerebrovasxular disease, cellulitis of toe of right foot, actinic keratosis, psoriasis, hyperlipidemia, intertrigo, dyspnea, dysphagia, and attention to gastrostomy, history of impacted cerumen in ears.",,"Ceftriaxone sodium, Augmentin",['Death'],1,MODERNA,IM 963456,OK,50.0,F,"Itching and throat felt tight and like was closing, blood pressure was about 186/70",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/21/2021,01/21/2021,0.0,OTH,no,no,"Crohn's, fibromyalgia, IBS, Ulcerative colitis",,"coconut, sulfasalazine, eggs, nuts, dairy, shellfish","['Pruritus', 'Throat tightness']",1,MODERNA,IM 963493,MO,25.0,F,"1 1/2 hours after receiving COVID-19 booster vaccination developed a non-progressive, constant throbbing headache [moderate to severe intensity] and associated with nausea, emesis[x1], photophobia, rotational vertigo, generalized malaise, fever 102.1 and lumbar bilateral pain. Came to the ED and was admitted to the hospital 1/20/21 for pain control.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/19/2021,01/19/2021,0.0,PVT,Tylenol; Advil; Wellbutrin XL; Maxalt; Cholecalciferol; Vitamin D2; Zolpidem,,Migraine headaches; obesity; anxiety/depression disorder,,,"['Back pain', 'Computerised tomogram head', 'Headache', 'Malaise', 'Nausea', 'Photophobia', 'Pyrexia', 'Vertigo', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 963554,AZ,25.0,F,"nausea, vomiting, diarrhea, palpitations and SOB. 911 was called to facility per doctors request patient transported to Hospital.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/21/2021,01/21/2021,0.0,PVT,Levothyroxine,NK,Hypothyroidism,,"Penicillin, Lidocaine","['Diarrhoea', 'Dyspnoea', 'Nausea', 'Palpitations', 'Vomiting']",1,MODERNA,IM 963582,NV,62.0,F,"Started with itching and rash at injection site. Went away in 2 days. Next day palm of hands and soles of feet became very itchy. Then progressed to whole body itching. Unable to sleep for two nights. Went to urgent care next morning. Was prescribed hydroxyzine 25mg. Itching went away that night and was able to sleep. Next day bilateral hands had numbness and tingling and general dizziness so stopped taking hydroxyzine. Went to family practitioner and was prescribed methylprednisolone dose pack. After starting steroids, by 2nd day (today - 1-21-21), hands continued n/t. Bilateral feet developed n/t. Dizziness continues when standing but goes away when sitting. Balance and gait are unsteady. Difficulty walking from weakness, balance issues, and dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/11/2021,6.0,PUB,"Vitamins, valsartan and hydrochlorothiazide 160-12.5, amlodipine 10mg, synthroid 88mcg, pravastatin 20mg",None,"Hypothyroidism, hypertension, high cholesterol",,Minocycline,"['Asthenia', 'Balance disorder', 'Blood test', 'Dizziness', 'Dizziness postural', 'Gait disturbance', 'Hypoaesthesia', 'Injection site pruritus', 'Injection site rash', 'Insomnia', 'Paraesthesia', 'Pruritus']",1,MODERNA,IM 963587,AK,40.0,M,"Chest pains, trouble breathing . Diagnosis: Non ST segment elevation myocardial infarction",Not Reported,,Yes,Yes,3.0,Yes,Y,01/12/2021,01/13/2021,1.0,PVT,"Tums, Pepcid AC",None,None,,None,"['Acute myocardial infarction', 'Chest pain', 'Dyspnoea', 'Electrocardiogram', 'Troponin increased']",2,PFIZER\BIONTECH,SYR 963588,OH,63.0,F,"Guillain-Barre syndrome was ultimately diagnosed Following information was described by patient: Typical symptoms started during the night of the vaccination on 12/20/21 as sore arm that became to move, then gradually the symptoms became worse and she developed a rash, nausea, and generally didn't feel well. She eventually went to the hospital on 12/31/20, at which point she was treated for her symptoms and released. By 1/7/21 she felt absolutely awful, she managed to get herself into a vehicle to leave the house to be medically evaluated but by the time she arrived she couldn't get out of the car, she reports her BP was 185/135 and she couldn't walk. At the ER they did a lumbar puncture and that's the last thing she remembers until Monday 1/18/21. At some point was admitted to ICU paralyzed with what was diagnosed as Guillain-Barre syndrome and she said they weren't sure she would make it. She is now alert and making a slow recovery now at a rehab facility and called the pharmacy today to report the incident to us now that she is able to speak again.",Not Reported,,Yes,Yes,,Not Reported,N,12/20/2020,12/21/2020,1.0,PHM,,,,,latex,"['Aphasia', 'Feeling abnormal', 'Gait inability', 'Guillain-Barre syndrome', 'Intensive care', 'Lumbar puncture', 'Malaise', 'Nausea', 'Pain in extremity', 'Paralysis', 'Rash']",1,GLAXOSMITHKLINE BIOLOGICALS,IM 963610,NM,63.0,M,Patient deceased on 01/17/2021,Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/17/2021,3.0,OTH,Asprin 81mg Calcium Acetate 667mg Ensure Plus Eucerin Furosemide 80mg Glipizide 5mg Omeprazole 20mg Renvela 800mg Rifampin 300mg Sensipar Vitamin D3,TB DMII Hyperlipidemia GERD CKD Renal Failure,MII Hyperlipidemia GERD CKD Renal Failure,,NKDA,"['Death', 'SARS-CoV-2 test positive']",1,MODERNA,IM 963973,TX,40.0,F,"Vaccine administered 1/16 in left deltoid- low grade temperature to 99.5, malaise, fatigue, dizziness, arm pain 7 hours post administration. 1/17- large axillary lymphadenopathy with continued fatigue 1/18- fatigue 1/19- supraclavicular and cervical lymphadenopathy bilaterally with mild sore throat and rhinorreah 1/20- lymphadenopathy improved. Temp to 99.9. Developed periumbilical and right lower quadrant pain 1/21- abdominal pain worsened. CT abdomen/pelvis with acute appendicitis for which I went to the OR for an appendectomy.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/16/2021,01/20/2021,4.0,PVT,Wellbutrin,None,None,,No,"['Abdominal pain', 'Abdominal pain lower', 'Appendicectomy', 'Appendicitis', 'Computerised tomogram abdomen', 'Computerised tomogram abdomen abnormal', 'Dizziness', 'Fatigue', 'Lymphadenopathy', 'Malaise', 'Oropharyngeal pain', 'Pain in extremity', 'Pyrexia', 'Rhinorrhoea']",2,MODERNA,SYR 963993,NC,78.0,F,Increase pulse; increase B/P; headache; light headed; unsteady lasting from 1/11/21-1/20/21.,Not Reported,,Not Reported,Not Reported,,Yes,N,01/01/2021,01/11/2021,10.0,PUB,"Levothyroxine sod.75mcg 1 daily; Pravastin sod. 20mg 1 daily, Vit. D 50 mcg daily",None,History of skin cancers;,,Lipitor; Zocor; Fluorouracil; Imiquimod; Travis; lactose; latex,"['Balance disorder', 'Blood pressure increased', 'Dizziness', 'Electrocardiogram', 'Full blood count', 'Headache', 'Heart rate increased', 'Magnetic resonance imaging heart']",1,PFIZER\BIONTECH,SYR 964048,CA,33.0,F,"At 15 min lips began to double in size, by 30 min unable to swallow, medical personal quickly reacted and gave me a shot of steroids and shot of antihistamine. Stabilized and left. Within 24 hours severe vomiting, by 1/16 hives on face, sensitivity to light, migraine, more vomiting. Spoke with dr got prednisone, continued vomiting, 1/19 spoke to PCP Got higher dose of steroids for hives and 8 mg zofran. 1/20-1/22 developed butterfly rash on face similar to lupus. Prescribed more steroids and Ativan to sleep. Follow up scheduled for two weeks",Not Reported,,Not Reported,Not Reported,,Yes,N,01/14/2021,01/14/2021,0.0,PUB,Benadryl welbutrin,None,Rheumatoid arthritis MRSAA,,Penicillin bee venom shellfish soy walnuts lavender,"['Butterfly rash', 'Dysphagia', 'Lip swelling', 'Migraine', 'Photophobia', 'Urticaria', 'Vomiting']",1,MODERNA,IM 967743,TX,77.0,M,"Possible seizer, unknown at this time, aprox 1hr and 20min after vac given. Passed away aprox 2hrs after vac.",Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,OTH,,n/A,Dementia,,,['Death'],1,PFIZER\BIONTECH, 963897,,50.0,F,"severe headache; Muscle aches; Chills; feeling tired and rundown; This is a spontaneous report from a contactable other healthcare professional (HCP)(patient). A 50-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on right arm single dose for COVID-19 immunization on 07Jan2021, 12:00PM, at 50-year-old. Medical history included: asthma. Known allergies reported as: Latex, penicillin. Concomitant medication was not reported. No other vaccine received in four weeks. The patient did not have COVID prior vaccination. The patient had muscle aches, chills, severe headache, feeling tired and rundown; all on 08Jan2021, 04:00 am. No treatment received. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the event was resolving. Information on the lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between event severe headache and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Asthma; Latex allergy; Penicillin allergy,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia']",1,PFIZER\BIONTECH,OT 963898,,44.0,F,"woke up with left sided chest pain and thought she may be having an MI; Injection received in left arm, resulting in extreme left side pain and soreness; woke up with left sided chest pain and thought she may be having an MI; Left upper body continues to be sore, not only at injection site but also left axillary area; Left arm is still warm although vaccine was received 72 hours ago; This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284), via an unspecified route of administration in the left arm on 08Jan2021 07:45 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient has no known allergies. Patient was not pregnant. Patient has no COVID-19 prior to vaccination. No other vaccines was given in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) given in the left arm on 21Dec2020 at 02:00PM for COVID-19 immunization. On 09Jan2021 at 03:00 PM, the patient experienced injection received in left arm, resulting in extreme left side pain and soreness. She woke up with left sided chest pain and thought she may be having an MI. Left upper body continues to be sore, not only at injection site but also left axillary area. This pain was not noted with her first vaccination. Left arm was still warm although vaccine was received 72 hours ago. This was not noted with her first vaccination. No treatment was given for the reported events. Patient was not tested for Covid post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event myocardial infarction with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,,,,,,"['Axillary pain', 'Chest pain', 'Flank pain', 'Injection site pain', 'Skin warm']",2,PFIZER\BIONTECH, 963899,,,M,"bladder infection; This is a spontaneous report from a contactable consumer (patient's spouse). A 65-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was scheduled to get his second dose on 16Jan2021 (reported as ""this coming Saturday""), but in the meantime the patient came down with a bladder infection and was taking Cipro 250 mg twice a day. He started on 09Jan2021 (reported as the past Saturday night) and finishes on 7am on 16Jan2021 Saturday, the day of the second vaccine. The reporter did not know if the patient should take it that day or wait or move the vaccine a few days out. He would still be in the 19-23 day (window). The reporter didn't know if it would fight off the COVID vaccine. Outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,,,UNK,,,,,,['Cystitis'],1,PFIZER\BIONTECH, 963900,,,F,"received the Covid vaccine 19Dec2020/then became Covid positive; exposed to Covid/Covid positive; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration on 19Dec2020 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient received the covid vaccine on 19Dec2020 /then became covid positive. The patient underwent lab tests and procedures which included Sars-Cov-2 test: positive on unknown date. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 963902,,,M,"Death; This is a spontaneous report from four non-contactable consumers via a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 28Dec2020 at a single dose for COVID-19 immunization. Ongoing medical history included Alzheimer's Disease, encephalopathy, hypertension, acute kidney failure, urinary retention and recent urinary tract infection (UTI), all from an unspecified date. Concomitant medication included acetaminophen (MANUFACTURER UNKNOWN), bisacodyl (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN), hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN), loperamide (MANUFACTURER UNKNOWN), ondansetron (MANUFACTURER UNKNOWN), senna alexandrina (SENNA PLUS), vitamin d3 (MANUFACTURER UNKNOWN). The patient had no known drug allergies. The patient experienced death on 30Dec2020. The vaccine was given on 28Dec2020 with no adverse events and no issues on 29Dec2020. The patient died on 30Dec2020, at approximately 2:00 AM. It was unknown if an autopsy was performed. It was unknown if the event was related to the suspect drug, the administrator marked as natural causes. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death",Yes,12/30/2020,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,UNK,ACETAMINOPHEN; ; ; ; HYDROCODONE/ACETAMINOPHEN; ; ; SENNA PLUS [SENNA ALEXANDRINA]; VITAMIN D3,Acute kidney failure; Alzheimer's disease; Encephalopathy; Hypertension; Urinary retention; UTI,,,,['Death'],UNK,PFIZER\BIONTECH, 963903,CA,57.0,F,"received the first dose of vaccine/tested positive for COVID-19; received the first dose of vaccine/tested positive for COVID-19; irritable all day; the sun had been bothering her eyes as she was driving, it was some eye sensitivity going on.; eyes were also hurting; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided), via an unspecified route of administration on 04Jan2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included allergies. The patient's concomitant medications were not reported. The patient reported that she received the first dose of the vaccine on 04Jan2021 and yesterday (11Jan2021) she tested positive for COVID-19. Patient would like to know if she should follow-up for the second dose of the vaccine on 25Jan2021. Patient mentioned that maybe she should follow up with the second dose. It was also reported that the patient wanted to know if the vaccine could have given her COVID-19 and tested positive. Patient further clarified it to be the Pfizer BioNTech COVID-19 Vaccine. Patient mentioned she is a caregiver and received the vaccine on last Monday (04Jan2021). On Friday (08Jan2021), the patient started to notice she was getting headaches. The headache started in the morning. Patient realized she was irritable all day and as a caregiver, this is not an attitude to have. Patient did not feel great that day. Patient also realized that the sun had been bothering her eyes as she was driving, it was some eye sensitivity going on. That night patient got home and was able to eat, but the next day on Saturday (09Jan2021), she did not have any sense of taste or smell. Patient had lost her sense of taste and smell. Patient realized this when she woke up at 6 am for coffee and could not taste or smell it. Patient was calling to find out if there was any way one could get Coronavirus only after the first shot and if she still needs to go and get her follow-up vaccine on 25Jan2021. Patient stated she forgot the name of her HCP. Patient also mentioned she has chest pressure. Patient noticed it about an hour ago, later stated it was like 11 something. It comes and goes. Patient mentioned that it was like shortness of breath. Patient would breathe in a little bit and it will bring the chest pressure back down. Patient would also walk around a bit to get the blood pumping back through. Patient also added, that due to these symptoms, she's locked off in a different room away from her husband. Patient stated they are both quarantining since her husband was exposed too and has not had the shot yet. Patient's eyes were also hurting, but that is due to the headache. Patient also stated that her eyes hurting has gone away. Patient will be getting to get a Coronovirus test done later today. When probed for the time of vaccination, patient that she was not sure. She knew she had to wait 30 minutes under observation because she had allergies. Patient initially stated that she would guess she received the vaccine thirty minutes prior to 3:55. Patient later clarified and stated it was possibly 2 something when she got it. Patient tested positive for COVID-19 on 11Jan2021 (COVID-19 virus test positive). Outcome of the event 'eyes were also hurting' was recovered, while unknown for the remaining events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/01/2021,,PVT,,,Medical History/Concurrent Conditions: Allergy,,,"['Ageusia', 'Anosmia', 'Chest discomfort', 'Dyspnoea', 'Eye pain', 'Feeling abnormal', 'Headache', 'Irritability', 'Photophobia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 963904,,27.0,F,"Neuropraxia of Left Arm; A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS This is a report from an interventional study source for Protocol C4591001 sponsored by BioNTech, managed and reported by Pfizer on the sponsor's behalf. The subject is in open-label phase of the study when the event occurred. A 27-year-old female with a medical history of seasonal allergies (Mar2006 and ongoing not taking any medications to treat) who received the first dose of blinded therapy (BNT162;PLACEBO) (dose 1) on 14Aug2020 at 10:34, second dose of blinded therapy (BNT162;PLACEBO) (dose 2) on 04Sep2020 at 09:27. The first dose of BNT162B2 (dose 3) on 23Dec2020 at 09:25, and the second dose of BNT162B2 (dose 4) on 11Jan2021 at 09:48. All intramuscularly in the left deltoid as a single dose for COVID-19 immunization. Concomitant medications included ethinyl-estradiol/norethisterone acetate (LOESTRIN) for birth control from May2014 and ongoing. There was no family medical history relevant to AE and no concomitant vaccine administered on the same date of investigational vaccine or other prior vaccine within four weeks. The subject experienced neuropraxia of left arm on 11Jan2021 at 09:51 considered an important medical event requiring a visit to physician office. The clinical course was the following: At 9:51, 3 minutes after receiving the second dose of BNT162B2 in left deltoid, the subject complained of left arm numbness and tingling starting at elbow and extending to fingers, weakness, and a weak grip in that hand. She also reported a decreased range of motion on the left side including her arm, shoulder joint, elbow, wrist, and metacarpophalangeal. Subject was afebrile with a normal vascular exam, no bruising, capillary refill time was less than 3 seconds. No antipyretic medication was administered. The investigator requested the subject to return to site the following day. On 12Jan2021, the investigator noted some improvement to symptoms but the subject was unable to return to work for several days after event. An appointment was scheduled with a neurologist for 13Jan2021. The action taken with BNT162B2 for the event was not applicable. The clinical outcome of the event was recovering. The investigator considered there was a reasonable possibility that the event neuropraxia of left arm was related to the second dose of BNT162B2 (dose 4) and clinical trial procedure (vaccination administration in the left deltoid, investigator did consider the location was appropriate), but unrelated to first and second dose of blinded therapy (BNT162;PLACEBO), first dose of BNT162B2 (dose 3) or concomitant medications. Per investigator, it was not likely that the event was related to the investigational product (IP) itself, however, that could not be 100% determined until neurologist had evaluated the subject.; Sender's Comments: The event ""Nerve Injury"" is unlisted in the Single Reference Safety Document (SRSD) of the Investigational Product therapy vaccine (BNT162B2). There is a reasonable possibility for the event ""Nerve Injury"" to be related to the procedure of vaccine (BNT162B2) administration (needle trauma) rather than to the product administered. The event would not be considered a unique response to this specific vaccine (BNT162B2). The case will be reassessed upon reception of neurological advice. Pfizer's safety database was reviewed for cases reporting PF-07302048 or blinded therapy through 31-DEC-2020 for adverse events encoding to MedDRA (v.23.1J) Preferred Term(s) of Nerve injury. Review of the database for the PT Nerve injury had the following results: 0 serious clinical trial cases and 1 non-clinical trial case. The impacts of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committee and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,OTH,LOESTRIN,Seasonal allergy (not taking any medications to treat.),,,,"['Asthenia', 'Capillary nail refill test', 'Grip strength decreased', 'Hypoaesthesia', 'Impaired work ability', 'Injected limb mobility decreased', 'Nerve injury', 'Paraesthesia']",4,PFIZER\BIONTECH,OT 963905,NJ,27.0,F,"tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patients mother) reported for a 27-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685), via an unspecified route of administration in the left arm on 17Dec2020 at single dose, for Covid-19 immunisation. Medical history included was sick 4-5 days in Feb2020 or Mar2020. There were no concomitant medications. After the 1st dose, the patient had fatigue after the 3rd day. After a week she felt like she had loose motions in other words diarrhea. She lost her smell and taste both (thought it was 27Dec2020). She got herself tested and it was positive. She tested positive on 28Dec2020. The outcome of event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/28/2020,11.0,UNK,,,Medical History/Concurrent Conditions: Sickness,,,"['Ageusia', 'Anosmia', 'Diarrhoea', 'Fatigue', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 963906,NJ,46.0,F,"Hypothermia 95.7 - 96.1F; chills; This is a spontaneous report from a contactable physician. A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1685/expiration date) via an unspecified route of administration on 11Jan2021 10:00 at a single dose on the left arm for COVID-19 immunization. Medical history included negative PCR nasal swab on 15Dec2020. Concomitant medications were not reported. The patient received the vaccine in a hospital. She did not receive other vaccines within 4 weeks prior to COVID vaccine. She was not diagnosed with COVID-19 prior vaccination and was tested for COVID-19 since vaccination (PCR, unknown result). The patient experienced Hypothermia 95.7 - 96.1F and chills on 12Jan2021. No treatment was received for the events. The outcome of the event was recovered. The reporter assessed the events as non-serious.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of hypothermia and chills due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/12/2021,1.0,PVT,,,Medical History/Concurrent Conditions: COVID-19 PCR test negative,,,"['Chills', 'Hypothermia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 963909,VA,46.0,F,"allergic reaction; patient was experiencing being flushed; fast heart rate; she wasn't feeling well a few minutes after receiving it; her throat felt thick; had trouble swallowing; This is a spontaneous report from a contactable other HCP and pharmacist. A 46-year-old female patient received the first dose of BNT162b2 (lot: EL3247, Expiry Date: May2021), via an unspecified route of administration in left arm on 15Jan2021 at 0.3 mL, single for covid-19 immunization. Medical history included food allergic. The patient's concomitant medications were not reported. The patient experienced allergic reaction on 15Jan2021. The patient alerted she wasn't feeling well a few minutes after receiving vaccine. The patient was experiencing being flushed, had a fast heart rate, and her heart rate kept increasing over time, despite two benadryl, the patient had allergic reactions in the past due to food, so the patient knew what it felt like, so could expect it, so the patient spoke up soon, and the Epipen was given 28-30 minutes later, and after that, the patient said her throat felt thick and she had trouble swallowing, so was taken to the hospital. The patient seemed to be getting worse, after time, after the Epipen. The patient was most likely admitted to the hospital. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/15/2021,01/15/2021,0.0,OTH,,,Medical History/Concurrent Conditions: Food allergy,,,"['Dysphagia', 'Flushing', 'Heart rate increased', 'Hypersensitivity', 'Malaise', 'Throat tightness']",1,PFIZER\BIONTECH, 963910,,,F,"She was tested positive even though she got the vaccine; She was tested positive even though she got the vaccine; This is a spontaneous report received from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse reported that a female patient of an unspecified age received BNT162B2 (reported as COVID-19 Vaccine, Batch/lot number: Unknown), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The Nurse was calling on behalf of the patient, the patient got Covid test back in Dec2020 and in last week of Dec2020 she received a positive Covid test. So she got the Covid vaccine back in Dec2020 and then a couple of weeks later which was last week of Dec2020 she got a Covid test and then she was tested positive even though she got the vaccine. The event outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, a causal relationship between event ""tested positive even though she got the vaccine"" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/01/2020,0.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 963912,,,F,"vertigo; runny nose; headache; joint pain; extreme fatigue; Initial information was received on 14-Jan-2021 regarding an unsolicited valid serious case received from a other health professional in United States. This case involved a 42 year old female patient who experienced vertigo, runny nose (rhinorrhoea), headache, joint pain (arthralgia) and extreme fatigue (fatigue), while she received INFLUENZA VACCINE. The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiration date not reported via unknown route at unknown administration site for prophylactic vaccination. On an unknown date, the patient experienced vertigo, runny nose (rhinorrhoea), headache, joint pain (arthralgia) and extreme fatigue (fatigue), unknown latency following the administration of INFLUENZA VACCINE. Seriousness criteria for all event was assessed as medically significant as per reporter. No relevant laboratory data was reported. It was not reported if the patient received a corrective treatment. The event outcome was reported as not resolved for all the events. There will be no information available on the batch number for this case.; Sender's Comments: This case concerns an 42 year old female patient who experienced vertigo, runny nose, headache, joint pain and extreme fatigue after vaccination with INFLUENZA VACCINE from unknown manufacturer. The time to onset is unknown. Moreover, concomitant medications, patient's medical condition at time of vaccination and laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Rhinorrhoea', 'Vertigo']",UNK,UNKNOWN MANUFACTURER,OT 963913,,,F,"her last flu shot, got made her sick; Initial information was received on 14-Jan-2021 regarding an unsolicited valid serious case received from a consumer. This case involved a 74 year old female patient for whom her last flu shot, got made her sick (illness) was reported, while she received INFLUENZA VACCINE. The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiration date not reported via unknown route at unknown administration site for prophylactic vaccination. On an unknown date, the patient for whom her last flu shot, got made her sick (illness) was reported, unknown latency following the administration of INFLUENZA VACCINE. The patient was hospitalized (caused or prolinged) for this event. No relevant laboratory data was reported. It was not reported if the patient received a corrective treatment. The event outcome was reported as unknown. There will be no information available on the batch number for this case.; Sender's Comments: This case concerns an 74 years old female patient who reported sickness after vaccination with INFLUENZA VACCINE from unknown manufacturer. The time to onset is unknown. At the time of event the patient had ongoing pulmonary arterial hypertension. Moreover, concomitant medications and laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,Pulmonary arterial hypertension,Comments: Pulmonary arterial hypertension,,,['Illness'],UNK,UNKNOWN MANUFACTURER,OT 964101,OR,37.0,F,"Severe vertigo and nausea, requiring hospitalization x2 days",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/03/2021,01/04/2021,1.0,PVT,Nonw,None,None,,NKDA,"['Blood test normal', 'Computerised tomogram head normal', 'Nausea', 'Vertigo']",1,MODERNA,IM 964218,IA,59.0,F,"Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and tingling of left arm, cheek, and tongue lasting 1.5-2 minutes. Numbness starts in elbow and radiates up and down arm. These episodes happen at various times thorughout the day. Sometimes her arm feels heavy. Has had an episode involving lip numbness that affected her seaking. Sometimes gets hot flashes lasting a few seconds. She contacted PCP to re-establish care on 1/11/21 after about 2 weeks of consistent, infrequent episodes. Never experienced this before. On 1/14 pt had an in person visit where she was evaluated by PCP. At ambulatory visit, BP 174/96. Other vital signs normal. Upper extremity exam: wrist (left, Phalen's test positive, Tinel test positive, no deformity, no crepitus), wrist (right, normal range of motion, Phalen's test negative, Tinel test negative), hand grips 5/5 bicep 5/5 tricep 5/5. Differential diagnosis: TIA, carpal tunnel syndrome, transient neurological event, shingles, hypertensive urgency. Anxiety could be component as well. Pt started ASA 81 mg QD and amodipine 5 mg QD. Plan to get carotid Dopplers to rule out TIA/stroke. Consider MRI in the future. 1/16/21: Pt developed left arm/leg numbness and tingling 0530 and reported to ED with stroke-like symptoms. During this encounter, pt states that she experiences these 1-3 minute episodes of tingling/numbness every hour or so (initially only had 1-2 per day, became more frequent in days immediately preceding 1/16). Pt reports not being able to stand that morning due to weakness in lower extremeties, though the symptoms resolved after sitting down. The patient denies any weakness to the right side, along with any family hx of stroke or headache. She takes omeprazole, amlodipine, and a baby aspirin daily. She does not currently follow up with a neurologist. The patient had lab work done yesterday and also recently had a US of her carotid artery which was unremarkable. She denies any weakness, numbness, or tingling currently. There are no other concerns at this time. The onset was 3 weeks ago. The course/duration of symptoms is worsening and episodic: lasting 3 minutes and with a frequency of every hour. Location: Left face, left upper extremity, left lower extremity. The character of symptoms is weakness, tingling and numbness. SBP 182/86. Temp 97.6 F. CT head ngative, bloodwork unremarkable, chest X-ray negative. Pt admitted for MRI of brain and C-spine. 1/17/21: Hospital notes note that symptoms apear to worsen when pt is stressed or she talks about it. MRI of brain w/ and w/o contrast completed and unremarkable. Pt declined C-spine MRI with and without contrast. Pt discharged. 1/19/21: Pt presented to outpt ambulatory appointment to follow up with worsening episodes of tingling in left arm/leg, numbness and tingling in mouth - is now effecting balance. Considering testing for other diseases such as syphilis, Lyme disease, multiple sclerosis, Guillaine-Barre. Priority status on referral to neurologist.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/23/2020,01/04/2021,12.0,WRK,Omega-3 fatty acids 1000 mg cap PO QD Omeprazole 20 mg cap PO QD Aspirin 81 mg tab PO QD (new start 1/14/21) Amlodipine 5 mg tab PO QD (new start 1/14/21),,Carpal tunnel syndrome GERD Hypertension H/o breast cancer s/p right lumpectomy and chemoradiation therapy Hyperlipidemia,,"Morphine - nausea, vomiting","['Anxiety', 'Balance disorder', 'Blood test normal', 'Carpal tunnel syndrome', 'Chest X-ray normal', 'Computerised tomogram head normal', 'Dysstasia', 'Herpes zoster', 'Hot flush', 'Hypertensive urgency', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Limb discomfort', 'Magnetic resonance imaging brain normal', 'Muscular weakness', 'NIH stroke scale', 'Neurological symptom', 'Paraesthesia', 'Paraesthesia oral', ""Phalen's test positive"", 'SARS-CoV-2 test negative', 'Scan with contrast normal', 'Speech disorder', ""Tinel's sign"", 'Ultrasound Doppler normal', 'Urine analysis normal']",1,PFIZER\BIONTECH,IM 964401,IL,56.0,M,"Pt died 4 days after vaccine, no known reaction to the vaccination",Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/16/2021,4.0,PVT,,,,,,['Death'],1,MODERNA,IM 964460,FL,73.0,M,"Sometime within 12 hours from receiving vaccine he had a stroke. He was taken to the emergency room on January 16, 2021 and tests were performed and he was transferred to Hospital on January 17, 2021. A MRI was performed on January 17, 2021 and showed that he had suffered a stroke. He was put on blood thinners and sent home on January 18, 2021. He had an appointment with MD on January 19, 2021. He has appointments with speech therapist, cardiologist and neurologist.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/15/2021,01/16/2021,1.0,OTH,,,Heart condition being monitored by Cardiologist,,,"['Blood test', 'Cerebrovascular accident', 'Computerised tomogram', 'Magnetic resonance imaging brain abnormal', 'X-ray']",1,MODERNA,SYR 964495,NC,90.0,F,Seizure-like activity. Started on Keppra,Not Reported,,Not Reported,Yes,2.0,Not Reported,,01/14/2021,01/18/2021,4.0,SEN,,,,,,['Seizure like phenomena'],1,MODERNA,IM 964525,MA,29.0,F,"Pt describes ""can't get a breath in"" Warm, dizzy, SOB, light headed, shaky Assessed by AMR and transported to ED Pt stated that she did not have any reaction to the first dose of the Moderna vaccine Pt stated that she was tested for COVID last week. Result was negative",Not Reported,,Not Reported,Yes,,Not Reported,U,01/20/2021,01/20/2021,0.0,WRK,propranolol Sertraline Protonix Topiramate PRN clonazepam,,Anxiety Depression GERD Sinus Tach,,NKDA,"['Blood glucose normal', 'Dizziness', 'Dyspnoea', 'Feeling hot', 'Tremor']",2,MODERNA,IM 964540,NC,82.0,F,"Possible Todd's Paralysis. h/o L craniotomy for meningioma. s/sx stroke ruled out, aphasia and R hemiparesis. Started on Keppra",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/14/2021,01/17/2021,3.0,SEN,,,,,,"['Aphasia', 'Hemiparesis']",1,MODERNA,IM 964598,MN,86.0,F,"At approx 5:13pm on 1/21/2021, change in status with being unresponsive to conversation, Face flushed, taken no food for fluids for the day. T-101.5-102.3 pulse 88-100 02 sat 86%. Unable to take anything orally. Dr updated with request to be evaled in ER. Admitted to rule out UTI, Covid test was negative, continued high temp, WBC count high.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/20/2021,01/21/2021,1.0,SEN,"ASA, Docu Liquid, Donepezil, Gabapentin, Melatonin, Calcium supplement, Pantoprazole, memantine, Metoprolol",none,"Alheimers dementia, hyperlipidemia, Diverticulosis, Benign Neoplasm of the colon, Allergic rhinitis, Anophthalmos R eye, hearing loss, tachycardia, benign positional vertigo , fall,",,No know allergies,"['Decreased appetite', 'Fluid intake reduced', 'Flushing', 'Hypophagia', 'Pyrexia', 'SARS-CoV-2 test negative', 'Unresponsive to stimuli', 'White blood cell count increased']",1,MODERNA,IM 964617,AK,77.0,F,"Death, which I believe is unrelated to vaccination",Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/21/2021,13.0,SEN,"Oxycodone, ventolin, quetiapine, pantoprazole, metoprolol, lorazepam, haloperidol, senna, levetiracetam","Alzheimers, Covid, COPD, Mood disorder, convulsions, HTN, anxiety, DM, parkinson's,","Alzheimers, Covid, COPD, Mood disorder, convulsions, HTN, anxiety, DM, parkinson's,",,Codeine,['Death'],2,PFIZER\BIONTECH,IM 964671,AK,100.0,M,Death on 1-5-21,Yes,01/05/2021,Not Reported,Not Reported,,Not Reported,N,12/18/2020,01/02/2021,15.0,SEN,"Omeprazole, metoprolol, prilosec,, isorbide, senna, nitro, lasix, fluticasone","DM, HTN, anemia, gout, BPH, atrial fib, heart failure, CAD, CKD,","DM, HTN, anemia, gout, BPH, atrial fib, heart failure, CAD, CKD,",,"NKDA, NKFA",['Death'],1,PFIZER\BIONTECH,IM 964724,AK,76.0,M,Death 1-15-21,Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,N,12/18/2020,01/15/2021,28.0,SEN,"prozac, olanzapine, alendronate, divalproex, mirabegron, metoprolol, proair,","Dementia, Bipolar, COPD, HTN, Schizoaffective","Dementia, Bipolar, COPD, HTN, Schizoaffective",,"NKDA, NKFA",['Death'],1,PFIZER\BIONTECH,IM 964795,OH,67.0,M,"Symptoms of fever (Tmax 102.9), diarrhea, and altered mental status started ~ 24 hours after vaccination. No evidence of septicemia with negative blood cultures Minimal improvement over 3 days, transferred to tertiary care center for MRI brain after which LP was recommended. However family declined as intubation would have been required and was not consistent with patient's goals of care.",Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,PVT,"Acetaminophen, Aspirin, Axitinib (Inlyta), Bisacodyl, Duloxetine, Ferrous Sulfate, Glucosamine Chondroitin, Norco, Tresiba, Lovastatin, Magnesium, Senna, Tamsulosin, Warfarin","Metastatic Renal Cell Carcinoma Diagnosed with COVID-19 on 12/7/2020, unknown severity of disease. Received first Pfizer SARS-COV-2 vaccine at the end of December","Insulin dependent Type 2 Diabetes, CKD3, atrial fibrillation, sick sinus syndrome s/p pacemaker on warfarin, hypertension, diastolic heart failure, gastric ulcers, emphysema",,Penicillin- Swelling of tongue and neck,"['Blood culture negative', 'Computerised tomogram head normal', 'Diarrhoea', 'Mental status changes', 'Pyrexia', 'White blood cell count normal']",2,PFIZER\BIONTECH,IM 964994,FL,71.0,M,1-03-2021dose at 9:30 arm pain 6:00 pm went to bed 11:00 woke up around 5:00 with significant breathing problems. Did not improve with albuterol. called 911 and was taken to the hospital ER. Loss of memory for 4-5 hours. don't know what happened,Not Reported,,Yes,Yes,4.0,Not Reported,Y,01/03/2021,01/04/2021,1.0,OTH,"tamsulosin, omeprazole, prednisone, quercitin, red yeast rice, antioxidant,",Covid 10-21-2020,stage 4 copd,,alleve,"['Amnesia', 'Dyspnoea', 'Pain in extremity']",1,MODERNA,IM 965063,OR,42.0,F,"Receiver second Pfizer shot on January 20 2021 and that night at 01:30 January 21,2021 I woke up with a rapid heart rate extreme headache and a fever of 102 I had shortness of breath and was taken to hospital. The ER performed a work up and my main complaint was my heart was hurting really bad I felt like my left carotid artery was swollen or occluded",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/20/2021,01/21/2021,1.0,PVT,,,,,,"['Angina pectoris', 'Chest X-ray', 'Dyspnoea', 'Echocardiogram', 'Electrocardiogram normal', 'Headache', 'Heart rate increased', 'Laboratory test normal', 'Musculoskeletal discomfort', 'Pyrexia', 'Troponin normal']",2,PFIZER\BIONTECH,IM 965106,VT,59.0,F,"1/6 Fatigue, diffuse slight buzzing skin arms, legs torso with mild nausea /anorexia, frontal headache 1/7 Severe fatigue but Insomnia. Difficulty concentrating. Diffuse myalgias/arthralgias in every muscle and joint, large & small, even fingers & toes. Nausea, anorexia, vomiting. Hot and cold chills, temp 96.7 pilo-erection. Severe mid-line low back pain L1-L2. Severe headache across low-forehead (just above eyebrows) to bilat temples to bilat cheek bones to maxillary incisors and canine teeth. Severe bilat eye pain (hurt to move or to touch eyes, but no photophobia or visual changes). Red-rimmed eyes. Facial pallor. Tender swollen left deltoid (left arm circumf 1"" > Rt arm). Tender Left Axillary adenopathy. 1/8/2021 - 1/10/2021 Sx remained severe 1/9/2021 - 1/17/2021 Gradual improvement in Sx w/decreased but persistent muscle/joint pain, mid-line low back pain, severe fatigue, anorexia, difficulty concentrating, anoexia and occasional vomiting. 1/18 - 1/22 Recurrent nausea w/ inc vomiting, increasing fatigue, increasing myalgias/arthragias, recurrent frontal/facial pain and eye pain, marked increase in mid-line low back pain, recurrent facial pallor and re-rimmed eyes.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,WRK,Estradiol vaginal cream,None,Hx Kidney stones,,"Bactrim, Benzoine, Phenergan","['Arthralgia', 'Back pain', 'Chills', 'Decreased appetite', 'Disturbance in attention', 'Eye pain', 'Facial pain', 'Fatigue', 'Feeling of body temperature change', 'Headache', 'Injection site pain', 'Injection site swelling', 'Insomnia', 'Lymphadenopathy', 'Myalgia', 'Nausea', 'Ocular hyperaemia', 'Pallor', 'Vomiting']",2,MODERNA,IM 965108,FL,89.0,F,"Pt got second dose of Pfizer after unremarkable first dose. 2 hours later at home developed garbled speech and confusion. Taken to ED and evaluated for acute stroke, TPA given. CT was not definitive. Weakness was R>L. Pt confusion worsened a bit into evening of day of event, but by the following morning pt had returned to baseline. Is an independent 89 yo who otherwise lives at home alone and is highly functioning. Pt did have a recent kyphoploasty and SI joint injection (perhaps with steroids/lidocaine). Currently patient hospitalized, expected discharge soon, only complaint is tingling in fingers.... we believe this may have been coincidental, but due to time course are reporting here.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/20/2021,01/20/2021,0.0,PVT,"alendronate, dorzolamide-timolol, escitalopram, famotidine, gabapentin, meolixcam",,"Depressive disorder, hyponatremia, lumbar foraminal stenosis, osteoarthritis, sacroiliac joint pain (L), spondylolisthesis of lumbosacral region",,bimatoprost topical ophthalmic,"['Computerised tomogram', 'Confusional state', 'Hemiparesis', 'Laboratory test', 'Paraesthesia', 'Perfusion brain scan abnormal', 'Speech disorder']",UNK,PFIZER\BIONTECH, 965186,IA,43.0,F,"at 15 mins post injection started to get extremely hot from Right side to left. Then like half of my body was cut head to toe in half and the left side of my body went numb and tingly. I could barely move my extremeties. Tounge began to burn like a 9volt battery was being held on it. I was taken to the ER and was told I had a rash on my chest neck and chin. I was treated with Epi IM, Benedryl, famotdine, then had epi again because my tounge felt fat and like a 9volt battery again. Epi went IV second does and had extreme pain with that. Had IV tylenol . Along with IV fluids. For the next 5 days I have had pain in my right harm , shoulder , neck into my head to the tip of my nose. The first 4 days were so bad that I could barely move and would get nauseated and throw up if I moved just right. each day the pains in my right arm,shoulder, neck and head did get better by about 25 percent each day. You could feel it getting better with each day I woke up. I was also having ear pain that seemed to be worse on 1/19/21. A PA checked my ears and said they were clear.Today, 1/22/21 is the first day I have been able to turn my head without being so sore and feeling nauseated. I was also very fatigued until today, 1/22/21. My hips and lower body are sore today and upper body seems to be less sore by 75%. I still am numb at times in my feet and fingers but can turn my head a lot better today.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/13/2021,01/13/2021,0.0,PVT,"Propanolol 80mg every night, Topriamate every night, cyclobenzoprine 10mg at night , Gummy Probiotic, One a day vitamin.",None,Migraines,,No known allergies,"['Arthralgia', 'Ear pain', 'Electrocardiogram', 'Fatigue', 'Feeling hot', 'Headache', 'Hypoaesthesia', 'Injection site pain', 'Laboratory test', 'Mobility decreased', 'Nausea', 'Neck pain', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Rash', 'SARS-CoV-2 test negative', 'Tongue discomfort', 'Tongue disorder', 'Vomiting']",1,MODERNA,IM 965209,,62.0,M,Pt admitted with a STEMI three days after vaccination with pzifer COVID-19 vaccine. Short time (<2hr) between symptoms onset and medical care. PCI on 1/14. Acute subtotal occlusion of proximal LAD and severe diffuse disease extending to distal LAD. Two DES to LAD (99% occluded) but RCA 50% and OMI1 60-65% also stenosed. Echo cardiogram 1/15. Pt noted to have severe wall motion abnormalities (severe hypokinesis of anterolateral and anteroseptal wall; akinesis of mid to distal anterior wall extending to the apex and distal inferior wall ) on echo. EF 30-35%. Received life vest on discharge.,Not Reported,,Yes,Yes,3.0,Yes,Y,01/11/2021,01/14/2021,3.0,PVT,Candesartan 4mg daily,None noted,"Hypertension, prediabetes",,None,"['Acute myocardial infarction', 'Coronary arterial stent insertion', 'Coronary artery occlusion', 'Coronary artery stenosis', 'Echocardiogram abnormal', 'Ejection fraction decreased', 'Percutaneous coronary intervention', 'Ventricular hypokinesia', 'Wall motion score index abnormal']",UNK,PFIZER\BIONTECH, 965226,AR,56.0,F,I developed a sudden onset of heart palpitations and went to the ER to find I was in Atrial Fib with RVR. Heart rate 166 upon arrival to the ED.,Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/08/2021,01/16/2021,8.0,PVT,"Levothyroxine 125mg QD, HTCZ 50 mg QD, Vit D3 5000IU daily, Hair and nail supplement",No,No,,no,"['Atrial fibrillation', 'Electrocardiogram', 'Laboratory test', 'Palpitations']",2,PFIZER\BIONTECH,IM 965256,GA,38.0,M,"Found deceased, presumed while exercising",Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/19/2021,27.0,MIL,Atorvastatin calcium 20mg daily,,Hypertension Hyperlipidemia Obstructive Sleep Apnea Obese Hearing loss Degenerative Disc Lumbar,,NKDA,['Death'],1,MODERNA,IM 965263,TN,37.0,F,"On 12/27 feet started feeling like pins sticking in then numbness & cold non stop. This sensation gradually moved up to the waistline area. Then total numbness, heaviness in legs, making it difficult to walk. There is also a raised, red rash that burns. Her symptoms are not better.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,12/21/2020,12/27/2020,6.0,PVT,"Topamax, phentermine, sertraline",hypertension,"hypertension, obesity",,NKA,"['Burning sensation', 'Gait disturbance', 'Hypoaesthesia', 'Immune system disorder', 'Laboratory test', 'Limb discomfort', 'Lumbar puncture', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging spinal', 'Myelitis transverse', 'Paraesthesia', 'Peripheral coldness', 'Rash erythematous', 'Rash papular']",1,PFIZER\BIONTECH,IM 965303,FL,70.0,M,BELLS PALSEY RIGHT SIDE OF FACE DROPPED,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/15/2021,01/16/2021,1.0,OTH,"AMLODIPINE,LOW DOSE ASPRIN,PANTORAZOLE,TAMSULOSINNONE",NONE,APRIRATED PNUMONIA 3 TIMES IN 5 YEARS,,NONE,"['Blood test', 'Computerised tomogram', 'Facial paralysis', 'Magnetic resonance imaging']",1,PFIZER\BIONTECH,SYR 965323,FL,71.0,F,Sudden onset of expressive aphasia the next morning (0915) after vaccination. Went to emergency room and diagnosed with stroke.,Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/13/2021,01/14/2021,1.0,PVT,"Baby aspirin, nifedipine",none,"hypertension, hyperlipidemia",,none,"['Aphasia', 'Blood test', 'Cerebrovascular accident', 'Computerised tomogram', 'Magnetic resonance imaging']",1,MODERNA,IM 965467,,,F,"passed out; almost like a seizure; fainted; saw sparks; pain of back; my whole body shook/shaking from cold; shaking from cold; teeth chattered; pain in the back of my head; This spontaneous report was received from a 88-year-old female patient. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown. Her concurrent condition included an unknown condition that she did not want to disclose (ill-defined disorder). On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not reported) for prevention of pneumonia. On an unknown date, the patient experienced ""a severe reaction"" to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), described as follows: immediately after receiving the vaccination the patient got up, saw sparks and fainted. She was put in a room where she had pain in the back of her head and small of her back, and she passed out. The patient's granddaughter picked her up in a car and the patient's body shook and her teeth chattered. She was put under three blankets for about three hours before it wore off. The patient's daughter ""looked it up"" and said she might have sore arms and chills but the patient reported she had none of that. The patient reported she never fainted before and it was almost like a seizure, she was shaking from cold so bad. On an unknown date (reported as 10 days later), she had bloodwork performed and it was all good. The patient's doctor did not know why the patient reacted this way but she is now afraid to take the COVID shot. The patient seemed confused by questions and repeated symptoms twice. She stated that the blood work was taken for another condition but did not want to disclose that condition. The patient did not seek medical attention. The outcome of the events was reported as recovered. The patient assessed the events as related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). Upon internal review the events of fainted, passed out and almost like a seizure were assessed as medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,Ill-defined disorder,,,,"['Back pain', 'Chills', 'Confusional state', 'Feeling cold', 'Headache', 'Immediate post-injection reaction', 'Loss of consciousness', 'Photopsia', 'Seizure like phenomena', 'Syncope', 'Tremor']",UNK,MERCK & CO. INC., 965547,,,M,"resident coded and expired; This is a spontaneous report from a non-contactable consumer via Pfizer Sponsored Program. A 63-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EH9899) intramuscular at single dose at left arm on 28Dec2020 for Covid-19 immunisation. Medical history included no current Illness, no known allergies, but preexisting conditions: dysphagia, violent behaviors, depressive disorder, schizophrenia, aspiration, gastrooesophageal reflux disease (GERD), hyperlipidaemia, bipolar disorder, rectal bleeding, hypertension. The patient had no birth defect. Concomitant medication included asa (ASA) at 81mg, lisinopril (LISINOPRIL) at 10mg daily, ferrous sulfate (FERROUS SULFATE) at 325 (unit unknown), olanzapine (ZYPREXA) at 20mg, morniflumate (FLOMAX [MORNIFLUMATE]) at 0.4 (unit unknown), famotidine (FAMOTIDINE) at 20mg, ascorbic acid (VIT C), carbamazepine (CARBAMAZEPINE) at 250mg bid, valproate semisodium (DEPAKOTE) at 750mg bid, metformin (METFORMIN) at 1000 (unit unknown) bid, sertraline (SERTRALINE) at 100 (unit unknown) bid, albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), buspirone hydrochloride (BUSPAR) at 10mg tid, polycarbophil calcium (FIBERCON). The patient died on 29Dec2020. The patient had no ER or Doctor visit and was not hospitalized. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: resident coded and expired",Yes,12/29/2020,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,UNK,ASA; ; ; ZYPREXA; FLOMAX [MORNIFLUMATE]; ; VIT C; ; DEPAKOTE; ; ; ALBUTEROL [SALBUTAMOL]; BUSPAR; FIBERCON,,Medical History/Concurrent Conditions: Aspiration; Bipolar disorder; Depressive disorder; Dysphagia; GERD; Hyperlipidemia; Hypertension; Rectal bleeding; Schizophrenia; Violent behavior,,,"['Cardio-respiratory arrest', 'Death']",1,PFIZER\BIONTECH,OT 965548,,88.0,F,"passed away; This is a spontaneous report from non-contactable consumers received via a Pfizer-sponsored program An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) via an unspecified route of administration on 30Dec2020 at a single dose (1 dose) in the left arm (LA) (administered by: senior living) as Covid vaccine. Medical history included patient was 14 plus days post COVID and unresponsive. The patient had no listed allergies. Concomitant medications were not reported. The patient passed away with an hour and half of receiving vaccine on 30Dec2020. Per nursing staff, they did not expect the patient to make it many more days. She was unresponsive in the room when shot was given. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: passed away",Yes,12/30/2020,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,,,Medical History/Concurrent Conditions: COVID-19 (patient was 14 plus days post COVID); Unresponsive to stimuli,,,['Death'],UNK,PFIZER\BIONTECH, 965549,NY,68.0,M,"Rash in the face that is itchy symmetric and bilateral; Rash in the face that is itchy symmetric and bilateral; This is a spontaneous report from a contactable physician (patient). A 68-years-old male patient received first dose bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Batch/lot number: EK5730) in Left arm, intramuscular on 06Jan2021 around 11:00 at SINGLE DOSE to prevent COVID, famotidine, oral from an unspecified date and ongoing at 40 mg, 2x/day for gastritis . Medical history included gastritis, ongoing diabetes (diagnosed 3 years ago), ongoing hyperparathyroidism (diagnosed many, many years ago), ongoing sjogren's syndrome (diagnosed recently this year), gout from 2010 and ongoing , coronary atherosclerosis from Nov2020 and ongoing, ongoing chronic obstructive pulmonary disease (diagnosed many years ago), asthma from 2020 and ongoing , sleep apnoea from 2019 and ongoing, crohn's disease from 1981 and ongoing, and abdominal pain. The patient's concomitant medications included ongoing ASPIRIN [ACETYLSALICYLIC ACID] (reported he takes aspirin everyday and the aspirin causes him to have some abdominal pain). The patient was administered with the first dose of the vaccine on 06Jan2021 and after that he developed a rash in the face that was itchy symmetric and bilateral on 08Jan2021. The rash was bilateral and symmetrical. The event was reported serious due to medically significant. Upon transfer, the caller clarifies he did not take steroids for the rash. A few days prior to receiving the COVID-19 vaccine, he started taking a new oral medication. So, he doesn't know if the rash is from the new medication or the vaccine, but he decided to call and report this event just in case. He clarifies the name of the new medication was famotidine. Today (12Jan2021) was the first day it was much better. Caller confirmed he did not take any steroids, the only medication he took was an antihistamine for the management of the symptoms. The outcome of the events was recovering.; Sender's Comments: The reported rash in the face that was itchy symmetric and bilateral occurred two days after the first dose of COVID 19 Vaccine, BNT162B2. Based on the plausible temporal association, the Company cannot completely exclude the possible causality between the reported events and the administration of the suspect. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/08/2021,2.0,PVT,ASPIRIN [ACETYLSALICYLIC ACID],"Asthma; COPD (diagnosed many years ago); Coronary atherosclerosis; Crohn's disease; Diabetes (diagnosed 3 years ago); Gout; Hyperparathyroidism (diagnosed many, many years ago); Sjogren's syndrome (Diagnosed recently this year); Sleep apnea",Medical History/Concurrent Conditions: Abdominal pain (reported caused by aspirin); Gastritis,,,"['Rash', 'Rash pruritic']",UNK,UNKNOWN MANUFACTURER,OT 965550,MN,61.0,M,"Bell's Palsy; This is a spontaneous report from a contactable other hcp. A 61-years-old male patient received bnt162b2 (BNT162B2; Lot # EH9899), intramuscular in the right arm on 17Dec2020 10:15 at single dose for Covid-19 immunisation . Medical history included lung neoplasm malignant , adenocarcinoma from an unknown date and unknown if ongoing. Concomitant medication included duloxetine (DULOXETINE), levetiracetam (LEVETIRACETAM), omeprazole (OMEPRAZOLE), olanzapine (OLANZAPINE), hydromorphone (HYDROMORPHONE) , fentanyl (FENTANYL PATCH), bisacodyl (BISACODYL). The patient experienced Bell's palsy on 02Jan2021 with outcome of recovered. The patient had to be treated in Emergency room/department or urgent care; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of Bell's palsy cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,01/02/2021,16.0,PVT,; ; ; ; ; FENTANYL PATCH;,,Medical History/Concurrent Conditions: Adenocarcinoma; Lung cancer,,,['Facial paralysis'],1,PFIZER\BIONTECH,OT 965551,MN,22.0,F,"dizziness then syncope; dizziness then syncope; This is a spontaneous report from a contactable Other HCP. A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 11Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history included situational anxiety, known allergies_penicillin. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient previously took amoxicillin;clavulanic acid (AUGMENTIN) and moxifloxacin and experienced allergies. The patient experienced dizziness then syncope on 12Jan2021 05:45. The patient underwent lab tests and procedures which included electrocardiogram: unknown results, laboratory test: unknown results. Therapeutic measures were taken as a result of dizziness then syncope. The outcome of the events was resolving. Information on batch/lot number was requested.; Sender's Comments: Based on the time association, the event syncope is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/12/2021,1.0,PVT,VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: Penicillin allergy; Situational anxiety,,,"['Dizziness', 'Electrocardiogram', 'Laboratory test', 'Syncope']",1,PFIZER\BIONTECH,OT 965552,FL,,F,"Swelling and Neuropathy in left extremities; Highest fever 103.5/febrile; Severe Nausea Vomiting; Severe Nausea Vomiting; Swelling and Neuropathy in left extremities; Vertigo; Severe migraine headache; This is a spontaneous report from a contactable Nurse (patient). A 43-years-old female patient received second dose of bnt162b2 (BNT162B2, lot_number=EL1284), intramuscular on 11Jan2021 15:00 at single dose on Left arm for covid-19 immunisation. Medical history included Hyperlipidemia, Mild Obesity (Treating with Medication), and Known- allergies: Strawberries - CT contrast, shellfish, iodine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included liraglutide (SAXENDA) and Medication for Mild Obesity. The patient historically received first dose of bnt162b2 for covid-19 immunisation. Details: (product=Covid 19, brand=Pfizer, lot_number=EH9899, administration_date=22Dec2020, administration_time=12:00 PM, administrator_route=Intramuscular, vaccine_location=Left arm, dose_number=1). After received second dose, the patient reported adverse-event included: Highest fever 103.5 - Severe Nausea Vomiting, Swelling and Neuropathy in left extremities, vertigo and severe migraine headache - continued to be febrile an additional 36hrs from injection time. Adverse-event-start-date: 11Jan2021. Adverse-event-start-time: 11:30 PM. Required medical management of nausea/vomiting with ondansetron 4mg; oxycodone 10mg for migraine. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit]. The patient underwent lab tests and procedures which included body temperature: Highest fever 103.5. The event outcome was recovering. This reported was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,PVT,SAXENDA,,"Medical History/Concurrent Conditions: Contrast media allergy (Allergies to medications, food, or other products: Strawberries - CT contrast, shellfish, iodine); Fruit allergy; Hyperlipidemia; Iodine allergy; Obesity (Mild Obesity (Treating with Medication)); Shellfish allergy",,,"['Migraine', 'Nausea', 'Neuropathy peripheral', 'Peripheral swelling', 'Pyrexia', 'Vertigo', 'Vomiting']",2,PFIZER\BIONTECH,OT 965553,NY,,M,"acute appendicitis; nausea; belly bloating; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose or covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 23Dec2020 and on 10Jan2021 (as reported) was admitted for acute appendicitis with abdominal complaints 2-3 days prior. His second dose was scheduled today (13Jan2021) but had not yet taken it due to this AE. He was looking for information on age range and timeframe of appendicitis reports related to covid. General concern was whether he can still take the shot today. Additionally, physician reported that around the 06Jan2021 he started experiencing nausea and belly bloating. On 09Jan2021 (as reported) he was admitted with very acute appendicitis and had to have surgery in the OR. He just got home yesterday (12Jan2021). It seemed to him that the appendicitis occurred too close to receive the vaccine for him not have to consider that it could have been a vaccine related issue for him. He was pretty sick from this and he was happy that he was back home. He was asking if it was safe for him to take the second vaccine given what happened with the first dose. The outcome of events was unknown.; Sender's Comments: Based on the temporal relationship, the association between the event appendicitis with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,12/23/2020,01/01/2021,9.0,UNK,,,,,,"['Abdominal distension', 'Appendicitis', 'Malaise', 'Nausea', 'Surgery']",1,PFIZER\BIONTECH, 965554,CO,46.0,F,"Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; This is a spontaneous report from a contactable Other HCP. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscularly on 28Dec2020 10:30 at single dose for covid-19 immunisation. Vaccine location: Left arm, dose number: 1, facility type vaccine: hospital. Medical history included viral asthma, hypertension, mild depression, anaphylaxis to Bee Stings, vertebral artery dissection with brainstem injury and covid-19 (If covid prior vaccination: Yes). Concomitant medication included acetylsalicylic acid (ASPRIN), metoprolol (METOPROLOL), omeprazole (PROTONIX [OMEPRAZOLE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity and fentanyl and experienced drug hypersensitivity. On 11Jan2021 02:00 the patient developed ""full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting up"". The patient was taken to emergency room (ER) /department or urgent care. In the ER all labs and CT with and without contrast clear, but was unable to find any other reason for the event. No treatment received. The events outcome is recovering. The action taken was not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/11/2021,14.0,PVT,ASPRIN; ; PROTONIX [OMEPRAZOLE]; ; WELLBUTRIN,,Medical History/Concurrent Conditions: Asthma; Bee sting hypersensitivity; COVID-19 (If covid prior vaccination: Yes); Depression; Hypertension; Vertebral artery dissection,,,"['Burning sensation', 'Computerised tomogram normal', 'Dizziness', 'Hypoaesthesia', 'Laboratory test normal', 'Scan with contrast normal']",1,PFIZER\BIONTECH,OT 965555,WI,,F,"dizziness; leg heaviness; feeling hot; tremors; feeling hot with heavy feeling in chest; lost consciousness; This is spontaneous report from a contactable pharmacist. An adult female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 at 11:45, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 28Dec2020, 20 minutes post vaccination, the patient reported dizziness. The patient was sitting in chair with head down with no improvement. When assisting patient to lie down, she lost consciousness. Patient's head and neck were supported so she did not hit head. The patient recovered consciousness and was alert and oriented with c/o leg heaviness and feeling hot. The patient denied difficulty breathing and chest heaviness. No rash noted. She lost consciousness a second time while lying flat. When she recovered consciousness, she was alert and oriented but had c/o leg heaviness, tremors and feeling hot with heavy feeling in chest. No rash noted. Blood pressure: 135/84, pulse: 70, O2 saturation: 99-100. Medical alert was called and the patient was transported to ED. Lost consciousness resolved on an unknown date. The other events outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event loss of consciousness cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,,,,"['Chest discomfort', 'Dizziness', 'Feeling hot', 'Limb discomfort', 'Loss of consciousness', 'Posture abnormal', 'Tremor']",UNK,PFIZER\BIONTECH, 965556,VA,,F,"3 near syncopal episodes; Arm soreness at injection site; Chills; muscle aches; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. A 49-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number=EL1283 via intramuscularly on 12Jan2021 10:30 at single dose Vaccine location: Right arm for covid-19 immunisation ,facility type vaccine: hospital. Medical history included hypertension and the first dose of BNT162B2 Lot number=EK5730 in Dec2020 10:00 Intramuscular, Vaccine location Right arm Facility type vaccine Hospital. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) and multi-vitamin. On 12Jan2021 22:00 the patient experienced 3 near syncopal episodes, arm soreness at injection site, chills and muscle aches. No treatment received. The event outcome was recovered and action taken is not applicable.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event near syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure high (High bp),,,"['Chills', 'Injection site pain', 'Myalgia', 'Presyncope']",2,PFIZER\BIONTECH,OT 965557,,58.0,M,"upper bicep pain/soreness around upper part of bicep; tendonitis; lymphadenopathy; sore deltoid; This is a spontaneous report from a contactable Other Healthcare Professional (patient). This 58-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot # EI0142, expiry date Mar2021), intramuscular once to the left deltoid, on 28Dec2020 at single dose for COVID-19 immunisation. Age at vaccination was 58-years-old. Medical history was none. Concomitant medications included an antihypertensive medication taking for several years. On 28Dec2020 the patient experienced side effects including sore deltoid (lasted for 2 days, Dec2020), and on 01Jan2021 the patient experienced upper bicep pain which he felt 5 days later (his friend said it may be lymphadenopathy). The caller had the COVID vaccine on 28Dec2020, and from 28Dec2020 he had a sore deltoid for a couple days, but then almost a week later developed, he thought it was tendonitis, it was the upper part of his bicep, really he could not extend his arm all the way, it was so painful in that area, and it's still somewhat painful, but better. The sore deltoid was pretty much after the shot and into the next 48 hours, that went away, then he noticed this soreness around the upper part of his bicep, not until, probably, maybe 5 days later, on 01Jan2021. He was chatting with someone, who mentioned soreness in the underarm area, that person felt it was lymph nodes, so maybe, there is possibility, caller thought this was muscle pain, as it hurts when he tried to extend his arm, it does not hurt when sitting here, but when he extends, especially over his head, it is really quite painful but it's lessened, he thought it was a tendonitis, but it could be the lymph nodes active or enlarged, he is not sure, he has never noticed lymph node pain, so he never knew what it was. Causality for soreness around upper part of bicep was reported as yes. He is pretty sure, since he has not done anything that aggravated that muscle, he can't think of anything, and it is in the general vicinity of the injection. States he is on an antihypertensive medication, but has been taking it for several years. He doesn't want to go through a report for the person he spoke to, who mentioned soreness in the underarm area, but it is interesting: the caller told him that had soreness, caller knows he also did report it, he reported it to Pfizer, actually he doesn't know if it was Pfizer or Moderna, but he reported it to whichever company, and said he thought was inflamed lymph nodes, so that was the first time he thought it was not muscle, but maybe the lymph node's reaction to vaccine, he has never experienced this kind of discomfort, he could not straighten his arm, as he would straighten the pain was at the upper insertion at the bicep, so that is where he came to this conclusion, his preliminary conclusions, he never thought it would persist this long. He thought, as time went by, it would be better tomorrow, and it has gotten better, but has not gone away. Sore deltoid was reported as non-serious while soreness around upper part of bicep was reported as serious medically significant because it has persisted for so long, he would have not expected it to keep going on, but it is almost going on two weeks. Outcome of the event soreness around upper part of bicep, lymphadenopathy, and tendonitis was not recovered while the outcome of the sore deltoid was recovered in Dec2020. His second dose is scheduled tomorrow (14Jan2021) and wants to know if he can still take it.; Sender's Comments: There is a reasonable possibility that the events myalgia and lymphadenopathy were related to BNT162b2 based on known drug safety profile. Based on the close temporal relationship, the association between the event tendonitis with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Injection site pain', 'Mobility decreased', 'Myalgia', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,OT 965558,WI,29.0,F,"Miscarriage; pregnant patient received the vaccine; pregnant patient received the vaccine; This is a spontaneous report from a contactable nurse (patient). This pregnant 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EK5730), intramuscular at single dose in the left arm on 20Dec2020 for COVID-19 immunisation. Medical history included none. Concomitant medication included venlafaxine. The patient experienced miscarriage (medically significant) on 09Jan2021 with outcome of recovering. Treatment unknown. The event required a visit to the emergency room. The patient was pregnant while taking BNT162B2. The patient was 4 weeks pregnant at the onset of the event. Patient last menstrual period date was 27Nov2020. The pregnancy due to deliver was on 03Sep2021. The vaccine was administered at Workplace Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. She received the second dose of BNT162B2 (Lot number EL0142), intramuscular in the left arm on 13Jan2021.; Sender's Comments: Based on the temporal relationship, the association between the event miscarriage with BNT162b2 can not be complete excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/20/2020,0.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Abortion spontaneous', 'Exposure during pregnancy']",1,PFIZER\BIONTECH,OT 965559,CA,40.0,F,"I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm; My face and ears got red and I begin to feel warm; Then My whole body felt really weird; my lips went numb; Afterwards for approximately 4 hours I could barely talk or open my eyes; Afterwards for approximately 4 hours I could barely talk or open my eyes; I got red rash on my neck and chest; I felt so weak, I could not move my body!; This is a spontaneous report from a contactable Other HCP reporting for herself. A 40-years-old female patient received the second dose bnt162b2 (BNT162B2) vaccine , intramuscular in the left arm on 18Dec2020 12:15 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. On an unknown date the patient received the first dose of the vaccine. The patient experienced got red rash on my neck and chest on 18Dec2020 12:15 with outcome of recovering , felt lightheaded on 18Dec2020 12:15 with outcome of recovering , face and ears got red and begin to feel warm on 18Dec2020 12:15 with outcome of recovering , then whole body felt really weird on 18Dec2020 12:15 with outcome of recovering , lips went numb on 18Dec2020 12:15 with outcome of recovering , begin to lose consciousness on 18Dec2020 12:15 with outcome of recovering , afterwards for approximately 4 hours could barely talk or open my eyes on 18Dec2020 12:15 with outcome of recovering , felt so weak, could not move my body on 18Dec2020 12:15 with outcome of recovering. The patient was hospitalized for one day for all the reported events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Dec2020 . The patient received Epipen injection, steroids, saline & Benadryl as treatment for the reported events. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,,,,,,"['Asthenia', 'Depressed level of consciousness', 'Dizziness', 'Erythema', 'Feeling abnormal', 'Feeling hot', 'Hypoaesthesia oral', 'Mobility decreased', 'Rash', 'Rash erythematous', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,OT 965560,NJ,54.0,F,"Low grade fever; Headache; Stomach ache; body ache; metallic taste in mouth; sore arm at injection site; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKQ231), via an unspecified route of administration at the left arm on 11Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 11Jan2021, patient experienced metallic taste in mouth, which was reported as worsened and sore arm at injection site. On 12Jan2021within about an hour after vaccination, the patient experienced lowgrade fever that was slowly going up, headache, stomach ache, & body ache. The patient has not recovered from the events.; Sender's Comments: Based on the time association, the reported events are possibly related to suspect BNT162B2 administration in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Abdominal pain upper', 'Dysgeusia', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 965561,,63.0,F,"respiratory distress; fever; anxiety developed requiring oxygen; Passed away; This is a spontaneous report via a Pfizer-sponsored program from a non-contactable consumer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included anaphylactic reaction (broad), neuroleptic malignant syndrome (broad), anticholinergic syndrome (broad), acute central respiratory depression (broad), hypersensitivity (broad), respiratory failure (narrow), drug reaction with eosinophilia and systemic symptoms (broad), hypoglycaemia (broad), COVID-19 (broad) and chronic obstructive pulmonary disease (COPD); all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium and lorazepam (ATIVAN). Within 24 hours of receiving the vaccine, the patient experienced fever, respiratory distress, and anxiety developed requiring oxygen, morphine and lorazepam (ATIVAN). The patient passed away on the evening of 26Dec2020. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: negative on an unspecified date. The outcome of the event death was fatal, while of the other events was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Passed a",Yes,12/26/2020,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/26/2020,3.0,UNK,LEVOTHYROXINE [LEVOTHYROXINE SODIUM]; ATIVAN,,Medical History/Concurrent Conditions: Anaphylactic reaction; Anticholinergic syndrome; Central respiratory depression; COPD; COVID-19; Drug reaction with eosinophilia and systemic symptoms; Hypersensitivity; Hypoglycaemia; Neuroleptic malignant syndrome; Respiratory failure,,,"['Anxiety', 'Condition aggravated', 'Death', 'Pyrexia', 'Respiratory distress', 'SARS-CoV-2 antibody test negative', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 965562,IL,,F,"Oxygen Saturations dropped to 80%; This is a spontaneous report from a contactable nurse. An adult female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140, expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included COVID-19 (covid prior to vaccination: yes) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced oxygen saturations dropped to 80% (The patient underwent lab tests and procedures which included oxygen saturation: 80% (dropped to 80%) on 08Jan2021. Therapeutic measures were taken as a result of the event which included treatment with the use of oxygen. The patient recovered from the event on an unspecified date.; Sender's Comments: The reported event of oxygen saturation 80% was most likely due to COVID-19 prior to vaccination, and unrelated to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/08/2021,,OTH,,,Medical History/Concurrent Conditions: COVID-19 (if covid prior vaccination: Yes),,,['Oxygen saturation decreased'],UNK,PFIZER\BIONTECH, 965563,NJ,43.0,M,"coughing quite a bit; seizure; his whole body feels sore; This is a spontaneous report from a contactable consumer (patient's mother). A 43-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3248) in right deltoid, on 11Jan2021 around 10:30, for COVID-19 immunisation. The patient was in high risk group, was living in senior facility and was disabled. Medical history included also ongoing hydrocephalus diagnosed when he was less than a year old, ongoing shunt (the first one when he was 11 months old, has had multiple revisions since then, the last in 2017), vagal nerve stimulator implantation ongoing from 2003 (for epilepsy; has had multiple since then, last one in 2015), ongoing hemiparesis since he was a baby and epilepsy (he was taking epilepsy drugs but it was well controlled). Concomitant medications included oxcarbazepine (TRILEPTAL) ongoing from 2000, at 1800 mg daily (600 mg in the morning and 1200 mg at night), for epilepsy and levetiracetam (KEPPRA XR) ongoing from 2000, at 1500 mg twice daily (in the morning and at night), for epilepsy. He was on prior medications to these, since he was young. Over the years he has changed to newer and better medications. On 11Jan2021 around 8-9 PM the patient experienced seizure. The patient has not had a grand mal seizure in over 5 years. On an unspecified date in Jan2021, after the vaccine, his whole body felt sore. He was unsure if it was from the seizure or the vaccine. The reporter also noticed that the patient had been coughing quite a bit on 12Jan2021 morning. Events outcomes were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/01/2021,,UNK,TRILEPTAL; KEPPRA XR,"Disability; Hemiparesis (since he was a baby); Hydrocephalus (Diagnosed when he was less than a year old); Living in residential institution (The patient was in high risk group); Medical device implantation (the first one when he was 11 months old, has had multiple revisions since then, the last in 2017); Vagal nerve stimulator implantation (for epilepsy. Has had multiple since then, last one in 2015.)",Medical History/Concurrent Conditions: Epilepsy (he was taking epilepsy drugs but it was well controlled); Grand mal seizure (has not had a grand mal seizure in over 5 years),,,"['Condition aggravated', 'Cough', 'Pain', 'Seizure']",1,PFIZER\BIONTECH, 965564,,58.0,M,Cardiac arrest Narrative:,Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/20/2021,6.0,OTH,,,,,,['Cardiac arrest'],1,MODERNA,IM 965565,NE,84.0,M,Narrative: Please note that patient is a hospice patient. Death occurred 10 days post vaccination. Providers do not believe that there was a correlation. Facility requires that we reports all death even if we suspect no correlation between death and vaccine. Symptoms: & death,Yes,01/05/2021,Not Reported,Not Reported,,Not Reported,,12/26/2020,01/05/2021,10.0,OTH,,,,,,['Death'],2,PFIZER\BIONTECH, 965571,MA,83.0,F,"1/13/21 pt came into clinic for vaccine. Had difficulty remembering age. Called me Mon. 1/18/21 stating she was sick. When asked what her sx were, she stated fatigue. She was well the night of the shot, Thur. and Fri. but became tired on Sat. and Sun. I went through other sx with her such as h/a, fever, n/v, muscle aches, weakness and she said she experienced none of those. I questioned her about eating and drinking and she said she ate and drank water. She seemed fine so I told her to call her doctor if she was worse or the fatigue persisted or call 911. She agreed. Two staff from clinic called her Mon. and Tues, (1/18 and 1/19). On Tues. she may have had sl slurred speech. She was found deceased on",Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,,01/13/2021,01/20/2021,7.0,PUB,Unknown,Unknown,Unknown,,Unknown,"['Death', 'Dysarthria', 'Fatigue', 'Malaise', 'Memory impairment']",UNK,MODERNA,IM 965634,WY,87.0,F,"1840 NSG staff notified that resident had fallen and was unable to get up. Upon arrival to resident, resident was lying on her right side outside of her room. Resident was severely diaphoretic and unable to state what had occurred. Resident had a blue tinge to her lips, wheezing bilaterally, equal strength bilaterally and very weak. BP 143/74, HR 66, 02 80%, temperature unable to read temporally due to diaphoresis. respirations equal and labored at 22 breaths per minute. EMS called. RN and CNA staff stayed with resident while waiting for arrival of EMS. During this time, son called resident's phone and he was updated of the situation. Upon EMS arrival at 1700, resident was regaining orientation and was no longer diaphoretic. EMS bs was 143. 02 placed on resident by EMS with 12 lead to be done on transport. EMS left with resident at approximately 1907. SJH ED called and given report to RN. DON notified.",Not Reported,,Yes,Yes,7.0,Not Reported,Y,12/28/2020,12/30/2020,2.0,SEN,Hctz 25mg Po Daily Vitamin D3 1000IU PO Daily Potassium Chloride ER 20 meq PO daily Metoprolol Succinate ER 25 mg PO daily Acetaminophen 650 mg PO Q6 hrs PRN pain Aspirin 81 mg PO Daily Symbicort 80-4.5mcg/act 1 puff BID Rosuvastatin Calciu,,"HTN, COPD, Hyperlipidemia, dementia",,NKA,"['Angiogram pulmonary abnormal', 'Asthenia', 'Blood lactic acid increased', 'Cyanosis', 'Disorientation', 'Dyspnoea', 'Fall', 'Hyperhidrosis', 'Pulmonary embolism', 'Troponin increased', 'Wheezing']",1,PFIZER\BIONTECH,IM 965658,NC,0.33,F,"Patient presented to Ed with rhythmic movements concerning for seizure. Seizure was witnessed by providers. Given versed, fosphenytoin. Lumbar puncture done and started on antibiotics. Placed on EEG.",Not Reported,,Not Reported,Yes,,Not Reported,,01/21/2021,01/21/2021,0.0,PVT,,,,,,"['Electroencephalogram', 'Laboratory test', 'Lumbar puncture', 'Seizure']",UNK,UNKNOWN MANUFACTURER, 965682,,35.0,F,"The patient was monitored for 15 minutes post vaccination with no issues. However on the drive home, she noticed some numbness of her right face as well as drooping on her eyelids. The patient came back to the hospital where she received her vaccine and checked into the ED. Physician's differential included Bell's Palsy vs CVA/TIA. The patient was discharged with prednisone 20mg daily for 7 days.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/15/2021,01/15/2021,0.0,UNK,"ascorbic acid (vitamin C), enoxaparin 80mg subQ daily, levornorgestrel 52mg intrauterine device",none,antiphospholipid syndrome,,none,"['Computerised tomogram head normal', 'Eyelid ptosis', 'Facial paralysis', 'Hypoaesthesia', 'Magnetic resonance imaging brain normal', 'Perfusion brain scan normal']",2,PFIZER\BIONTECH,IM 965715,FL,57.0,F,"viral cardiomyopathy, myopericarditis, weakness, chest pains",Not Reported,,Yes,Yes,3.0,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,None,None,Breast Cancer 2010,,None,"['Asthenia', 'Blood test', 'Catheterisation cardiac', 'Chest pain', 'Echocardiogram', 'Electrocardiogram', 'Magnetic resonance imaging', 'Myocarditis', 'Viral cardiomyopathy']",1,MODERNA,IM 965753,,23.0,F,"Acute Angioedema. Treated with multiple rounds of epinephrine, solumedrol, diphenhydramine, famotidine. Admitted to the ICU for continued monitoring and treatment. ICU time 42 hours.",Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/15/2021,01/15/2021,0.0,PVT,none,none,none,,none,"['Angioedema', 'Intensive care']",UNK,PFIZER\BIONTECH, 965757,AK,47.0,M,"01/18/2021-Patient became short of breath with c/o throat tightness and difficulty speaking 30min post vaccine. Given epi 0.3mg subcutaneous, Benadryl 50mg by mouth, placed on cardiac monitor for 4 hours with mild tachycardia post epi. Solu medrol 125mg given IV. Sent home and then returned 38 hours later with c/o epigastric pain, nausea, vomiting and weakness. Sent to Medical Center",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/18/2021,01/18/2021,0.0,PVT,"Amlodipine, Losartan 100mg daily, Epi pen",,"HTN, BHP, Hyperlipidemia., OSA and Anaphylaxis to onions",,Onions and Sulfa drugs,"['Abdominal pain upper', 'Asthenia', 'Blood potassium decreased', 'Cardiac monitoring abnormal', 'Dyspnoea', 'Electrocardiogram ST segment depression', 'Haematocrit increased', 'Haemoglobin increased', 'Nausea', 'Red blood cell count increased', 'Speech disorder', 'Tachycardia', 'Throat tightness', 'Troponin increased', 'Vomiting', 'White blood cell count increased']",1,MODERNA,IM 965769,FL,78.0,M,"Patient is extremely comprised due to a kidney transplant 7.5 years ago. The first day patient just had a sore arm. The next the day the 14th had chills, shaking then to bone pain and muscle pain and headache over a period about 4 or 5 days. Then patient started with very bad diarrhea, it was uncontrolled multiple times a day, about 3 days, he was getting dehydrated and muscle weakness. Patient went to the hospital 1/20/2021 and was admitted and the doctors are still trying to determine the cause of the diarrhea. Patient is extremely dehydrated and is still has the diarrhea. Patient is right now is hallucinating due to being so dehydrated. A stool culture has been preformed.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/13/2021,01/14/2021,1.0,PUB,"Prograf twice a day, Cellcept twice a day, Pradaxa twice a day, Northera three times a day, Fludrocortisone twice a day,",,Kidney transplant 7 1/2 year ago. Shore bell syndrome and dumping syndrome,,"IV Contrast, tetanus anti toxins, doxycycline, IV iron (very serve reaction)","['Bone pain', 'Chills', 'Culture stool negative', 'Culture urine negative', 'Dehydration', 'Diarrhoea', 'Hallucination', 'Headache', 'Muscular weakness', 'Myalgia', 'Pain in extremity', 'Tremor']",1,MODERNA,SYR 965801,FL,62.0,M,"1/14 vaccine, code blue in hospital 1/15, discharged 1/20",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,01/14/2021,01/15/2021,1.0,PVT,,,,,,['Cardio-respiratory arrest'],1,MODERNA,IM 965807,GA,90.0,F,"began itching within 24 hours, within 5 days couldn't move on her own, by 6th day was having respiratory issues, by day 7 unresponsive, by day 8 dead",Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,SEN,"metoprolol, methotrexate, calcitrol, digoxin, calcium prednisone, clopidogrel, levothyroxine, folic acid, pantoprazole, eliquis, atorvastatin, latanoprost, melatonin",nose bleeds,"rheumatoid arthritis, atrial fibrillation",,Penicillin,"['Death', 'Immobile', 'Pruritus', 'Respiratory disorder', 'Unresponsive to stimuli']",1,MODERNA,SYR 965812,MN,86.0,F,"Tenant developed nausea/vomiting in the middle of the night after vaccination. The next day she continued with GI upset, fever, and body aches. Toward the afternoon with Tylenol she appeared to be feeling better. At around 6pm she had sudden onset shortness of breath and respiratory distress. Nebulizer was given without improvement, O2 sats were in the 70's and 80's. Tenant was transported to the hospital via ambulance",Not Reported,,Not Reported,Yes,,Not Reported,N,01/20/2021,01/21/2021,1.0,PVT,,None,"Diabetes, chronic cough, edema, PAD, Hypertension",,Penicillin (rash) Cat dander/hair,"['Abdominal discomfort', 'Blood lactic acid increased', 'Dyspnoea', 'Fibrin D dimer increased', 'Nausea', 'Pain', 'Procalcitonin increased', 'Pyrexia', 'Respiratory distress', 'SARS-CoV-2 test positive', 'Troponin increased', 'Vomiting', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 965831,MI,74.0,F,"Patient received her first dose of vaccine on Monday, January 18th. Two days later on Wednesday, January 18th, she retired to bed early. Later that night when her husband went to bed, he found her in the bed deceased. No other details of the event are know.",Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/20/2021,2.0,PVT,Albuterol Sulfate HFA 108 MCG/ACT AERS Allopurinol 300 MG Oral Tablet Aspirin Low Dose 81 MG TABS Baclofen 10 MG Oral Tablet Bystolic 10 MG Oral Tablet Clobetasol Propionate 0.05 % External Cream Cyanocobalamin 1000 MCG TABS Fish Oil,"Emergency Room Visit 1/7/2021 complaining of shortness of breath and swelling. She and elevated D-dimer with no evidence of a Pulmonary Embolus. Persantine Myoview showed small mild area of reversible ischemia to the inferolateral apical wall. Mild symptoms of vague discomfort in her chest, but nothing that has been reproducible with activity. She is chronically short of breath with limited activities because of problems with her hip","Active Problems Abdominal distention (R14.0) Cellulitis (L03.90) Chronic hip pain (M25.559,G89.29) Chronic UTI (N39.0) Colon polyps (K63.5) Coronary artery disease involving native coronary artery of native heart with angina pectoris (I25.119) Edema, leg (R60.0) GERD (gastroesophageal reflux disease) (K21.9) Gout (M10.9) Left kidney mass (N28.89) Lump of right breast (N63.10) Morbid obesity (E66.01) Neuropathy, diabetic (E11.40) Pain with urination (R30.9) Protein in urine (R80.9) Respiratory crackles at right lung base (R09.89) Type 2 diabetes mellitus (E11.9) Venous (peripheral) insufficiency (I87.2)",,"Allergies: Brilinta, ACE Inhibitors, Bactrim, Cipro, Codeine Derivatives, Penicillins, Statins, sulfa",['Death'],1,MODERNA,IM 965860,OH,84.0,M,Patient had increased SOB while at home. EMS was called. Patient coded in the squad,Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,PVT,,,,,,"['Cardio-respiratory arrest', 'Dyspnoea']",UNK,MODERNA, 965878,DE,50.0,F,unknown,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/20/2021,01/20/2021,0.0,PVT,unknown,unknown,unknown,,unknown,['Unevaluable event'],UNK,MODERNA,IM 965910,DC,53.0,F,The employee found dead at her home on 1/21/2021.,Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/22/2021,11.0,PVT,not known,not known,not known,,not known,['Death'],2,PFIZER\BIONTECH,IM 965914,PA,38.0,F,Acute abdominal pain= acute appendicitis,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/06/2021,01/08/2021,2.0,PVT,N/a,None,None,,Ancef and morphine,"['Abdominal pain', 'Appendicitis', 'Computerised tomogram']",2,PFIZER\BIONTECH,IM 965922,MD,75.0,M,We were alerted that the patient died at home.,Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/22/2021,3.0,PUB,unknown,pt denied,pt denied,,pt answered no,['Death'],1,MODERNA,IM 966028,MI,39.0,F,Petechial rash,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,01/21/2021,2.0,PVT,Zoloft,Dental infection,,,Prozac,"['Petechiae', 'Platelet count decreased']",UNK,PFIZER\BIONTECH,SC 966079,MO,25.0,F,"PT stated she felt funny. Began assessment. PT lost pulse, began CPR. PT regained pulse, was transferred via EMS to hospital",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,PUB,None,None,None,,None,"['Feeling abnormal', 'Pulse absent', 'Resuscitation']",1,PFIZER\BIONTECH,IM 966094,VA,31.0,F,"Mild-to moderate sore throat; started about 24 hours after the vaccine and lasted for about 24 hours. I didn't have to take any medication for it and didn't have to call out work. Was a lot more more fatigued that day of the sore throat. Pregnancy- Sept 6, 2021; normal; low risk pregnancy",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,Prenatal Vitamins,nothing,nothing,,Sulpha; amoxicillin,"['Fatigue', 'Oropharyngeal pain', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,SYR 966142,WA,57.0,M,"HPI from ED: 57-year-old male with history of reactive airway disease, T2DM, OSA presenting with shortness of breath. Patient states 2 days ago, he had to take his dog to the vet, and they accidentally ran away; he had to run ""full tilt"" to catch it, which caused him to become acutely short of breath. Since then, he has had worsening difficulty breathing with any type of exertion, progressing today to dyspnea at rest. He has been using albuterol several times per day (3-4 times today), as well as his BiPAP machine that he uses for OSA, during the day without relief. Denies chest pain, though he has chest tightness associated with difficulty breathing. History of similar difficulty breathing with exertion during the winter, but never this bad; has not been hospitalized or intubated for RAD. Got his second COVID vaccine 3 days ago, after which he had fevers, now resolved. Denies recent antibiotics; no history of COPD, slight cough today, not productive of sputum, no hemoptysis. Reports a month of right leg swelling; has a history of prior right knee surgeries; no posterior calf pain, no acute changes; no history of VTE, no history of cancer, no hemoptysis, no recent procedures/surgeries/immobilizations.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/19/2021,01/19/2021,0.0,MIL,,,"history of reactive airway disease, OSA, Diabetes mellitus type II, Obesity (BMI 30-39.9)",,,"['Bilevel positive airway pressure', 'Chest discomfort', 'Condition aggravated', 'Cough', 'Dyspnoea', 'Dyspnoea at rest', 'Dyspnoea exertional', 'Pyrexia']",UNK,PFIZER\BIONTECH, 966177,CO,31.0,F,"Fatigue, Myalgias, Speech Difficulty, and Numbness, left facial weakness",Not Reported,,Not Reported,Yes,2.0,Not Reported,,01/20/2021,01/21/2021,1.0,PVT,,,,,,"['Facial paresis', 'Fatigue', 'Hypoaesthesia', 'Myalgia', 'Speech disorder']",2,MODERNA,IM 966178,WI,89.0,M,Pt called son to let him know he couldn't breath around 2 AM. Pts son showed up at his house 10 minutes later and ambulance arrived with in 20 minutes at 2:15,Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/22/2021,3.0,PHM,"acetaminophen 600 mg every 4 hrs, albuterol 2 puffs every 6 hrs, Symbicort 2puffs 2 x days, vitamin D, B12, Prozac 20 mg once per day, Veramyst 1 spray once per day, Lisinopril 5 mg once per day, Prilosec 40 mg once per day, Probiotic daily",skin ulcer of lower right leg due to old gun shot wound,"alcoholism in remission, aortic stenosis-mild, arthritis, blood loss anemia, carpel tunnel syndrome bilateral, cellulitis of right leg, chronic insomnia, COPD, diverticulosis of sigmoid and descending colon, eczema, gun shot wound of leg, heart murmur-right upper external border, hemorrhoids, history of blood transfusion, history of falling, lyme disease, osteoarthritis of left knee, pneumonia, polyp of colon flat, peripyloric ulcer, peptic ulcer disease, sleep apnea, unspecified essential hypertension, viral meningitis",,aminoglycosides and sulfa meds,['Dyspnoea'],1,PFIZER\BIONTECH,IM 966183,IN,29.0,F,"I received the vaccine on 1/19/2021 at my place of employment. Upon getting the vaccine approx 30 minutes after receiving i became very itcy, and my lips were burning/tingling. The itching continued to get worse, forming red rash on my chest. I called my MD at this point. I was told to take benadryl and to go to er if it became worse. I took benadryl. the itching continued for 2 days. i also experienced pain at injection site, headache, nausea, diarrhea, extreme fatigue, muscle soreness. on 2nd day after vaccine i woke up and my muscles continued to be very sore. like i had just completed a marathon. I also have this sensation that started with the increased muscle pain. The only way i can explain it is that it feels like how a TENS unit feels, but its coming from the inside. especially in my back and thighs. this continues. i feel like i could just start shaking at any time. i cannot sleep but i am so tired. i was seen at dr today and i was told to report this to you guys. this sensation has not went away and has actually cause my muscles to spasming. MD said the vaccine effected my muscles and possibly neurologically as well.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/19/2021,01/19/2021,0.0,PVT,"Levothyroxine, fluoxetine, metoprolol succinate, lyrica, cyclobenzaprine, omeprazole, senna, vitamin B, spironolactone, zofran,",none,"Lupus, Hashimoto's, Asthma, GERD, HTN, Chiari malformation, fibromyalgia, hypothyroidism, neuropathy, myalgia, Rheumatoid arthritis, Cervical radiculopathy, vitamin D deficiency.",,Sulfa and Keflex,"['Diarrhoea', 'Fatigue', 'Headache', 'Injection site pain', 'Insomnia', 'Muscle spasms', 'Myalgia', 'Nausea', 'Oral discomfort', 'Paraesthesia oral', 'Pruritus', 'Rash', 'Rash erythematous', 'Sensory disturbance']",1,MODERNA,IM 966195,VA,21.0,M,"Patient admitted to hospital for progressive bilateral lower extremity weakness, sensory changes and inability to ambulate. Neuroimaging with significant degenerative disc disease with disc protrusions throughout the lumbar spine, greatest L3-L4, and with severe central stenosis. Question of radiculopathy vs peripheral neuropathy at admission, but no acute findings such as cauda equina syndrome. EMG consistent with atypical variant of GBS--acute motor sensory axonal neuropathy.",Not Reported,,Not Reported,Yes,,Not Reported,,12/21/2020,01/18/2021,28.0,PVT,,,History of neonatal stroke with VP shunt (valve replaced 2020),,,"['Acute motor-sensory axonal neuropathy', 'Electromyogram abnormal', 'Gait inability', 'Guillain-Barre syndrome', 'Intervertebral disc degeneration', 'Intervertebral disc protrusion', 'Lumbar spinal stenosis', 'Magnetic resonance imaging spinal abnormal', 'Muscular weakness', 'Sensory disturbance']",UNK,PFIZER\BIONTECH, 966224,NE,,F,"Received Vaccine on 1/8/2021. Reported on 1/19/2021 that on 1/16/2021 developed hives, heart racing, dizziness. Called 911. had an anaphylactic shock. had o2 and steroid treatment. She feels better now and would like to return to work.",Not Reported,,Yes,Not Reported,,Not Reported,Y,11/30/1983,01/16/2021,13562.0,PVT,albuterol Fexofenadine fluticasone-salmeterol Levetriacetam monelukast pantoprazole zonisamide,,,,"motrin, penicillin","['Anaphylactic shock', 'Dizziness', 'Palpitations', 'Urticaria']",1,PFIZER\BIONTECH,IM 966232,MN,25.0,F,"Began having nausea, body aches and pains and the chills around 10am 1/19. Was unable to eat anything without emesis for 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/19/2021,1.0,PVT,"Set trail with, prenatal vitamin",,Anxiety,,Sulfa,"['Chills', 'Nausea', 'Pain', 'Vomiting']",2,PFIZER\BIONTECH,IM 966255,NY,75.0,F,After receiving vaccine patient started to feel hot and face turning red. She reported feeling like she was tight in the chest and throat was swelling. She said she had an epi pen with her. I asked her if she thought it was time to administer and call 911 she said yes. We proceeded. She said her throat was feeling a little better but chest was tight and she was having a dry cough. Ambulance took her to hospital. I called her around Noon the next day to check in on her and she said she was in hospital still being monitored. Was advised not to get second dose of vaccine from hospital.,Not Reported,,Not Reported,Yes,,Not Reported,U,01/21/2021,01/21/2021,0.0,PHM,,,Arthritis ....N/A,,yes N/A,"['Chest discomfort', 'Cough', 'Erythema', 'Feeling hot', 'Pharyngeal swelling']",1,MODERNA,IM 966295,AR,30.0,F,"30 yr old getting vaccinated as an employee of hospital. Within minutes of vaccination, developed tingling in mouth, swelling of tongue, rash on arms and chest (rest of body not examined in room). GIven epi and brought to ER. BP within normal range, exact number not available. In ER given Benadryl and Pepcid, other medications not recollected. Admitted for observation into hospital for one night, discharged next day and doing well.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,none known,none,,,"['Paraesthesia oral', 'Rash', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 966306,SD,67.0,M,"Hives, Skin turned red, and face turned red in warm, over span of 1 hour from vaccination time. Starting to have Shortness of breath and chest felt tight prior to being transported to Emergency room.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/22/2021,0.0,SEN,"Barrier cream, Desenex to feet, Aquaphor Ointment, Benadryl, Biofreeze, Digoxin, Duloxetine, Ferrous Sulfate, Furosemide, Guaifenesin ER, Losartan Potassium, Melatonin, Milk of Magnesia, MIraLax, Mirapex, movantik, Iron, Nitroglycerin, Omeg",None,"PARAPLEGIA, INCOMPLETE (G82.22) 4/23/19 Primary Admission PERSONAL HISTORY OF COVID-19 (Z86.16) 1/1/21 Secondary During Stay COVID-19 (U07.1) 11/7/20 12/31/20 Secondary During Stay ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS (I25.10) 3/23/20 Secondary History OTHER CHRONIC PAIN (G89.29) 3/23/20 Secondary History URINARY TRACT INFECTION, SITE NOT SPECIFIED (N39.0) 2/21/20 4/1/20 Secondary NEUROMUSCULAR DYSFUNCTION OF BLADDER, UNSPECIFIED (N31.9) 1/20/20 Secondary HYPOXEMIA (R09.02) 8/21/19 Secondary SLEEP RELATED HYPOVENTILATION IN CONDITIONS CLASSIFIED ELSEWHERE (G47.36) 8/21/19 Secondary METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS INFECTION AS THE CAUSE OF DISEASES CLASSIFIED ELSEWHERE (B95.62) 7/30/19 11/1/19 Secondary URINARY TRACT INFECTION, SITE NOT SPECIFIED (N39.0) 7/30/19 8/14/19 Secondary OTHER REDUCED MOBILITY (Z74.09) 7/1/19 11/1/19 Secondary OTHER SYMBOLIC DYSFUNCTIONS (R48.8) 7/1/19 11/1/19 Secondary CARDIOMYOPATHY, UNSPECIFIED (I42.9) 5/31/19 Secondary During Stay INSOMNIA, UNSPECIFIED (G47.00) 5/31/19 Secondary During Stay PRIMARY OSTEOARTHRITIS, UNSPECIFIED SITE (M19.91) 4/23/19 Secondary History RESTLESS LEGS SYNDROME (G25.81) 1/9/19 Secondary During Stay ACUTE ON CHRONIC COMBINED SYSTOLIC (CONGESTIVE) AND DIASTOLIC (CONGESTIVE) HEART FAILURE (I50.43) 11/30/18 Secondary Admitting Dx ACUTE PANCREATITIS WITHOUT NECROSIS OR INFECTION, UNSPECIFIED (K85.90) 11/30/18 12/1/20 Secondary History ESSENTIAL (PRIMARY) HYPERTENSION (I10) 11/30/18 Secondary History GASTROINTESTINAL HEMORRHAGE, UNSPECIFIED (K92.2) 11/30/18 Secondary History HYPERLIPIDEMIA, UNSPECIFIED (E78.5) 11/30/18 Secondary History LOW BACK PAIN (M54.5) 11/30/18 Secondary History MAJOR DEPRESSIVE DISORDER, RECURRENT, UNSPECIFIED (F33.9) 11/30/18 Secondary History MALIGNANT NEOPLASM OF PROSTATE (C61) 11/30/18 Secondary History MORBID (SEVERE) OBESITY DUE TO EXCESS CALORIES (E66.01) 11/30/18 Secondary History OBSTRUCTIVE SLEEP APNEA (ADULT) (PEDIATRIC) (G47.33) 11/30/18 Secondary History OTHER ASTHMA (J45.998) 11/30/18 Secondary History OTHER POLYOSTEOARTHRITIS (M15.8) 11/30/18 Secondary History OTHER RHEUMATOID ARTHRITIS WITH RHEUMATOID FACTOR OF MULTIPLE SITES (M05.89) 11/30/18 Secondary History OTHER SPECIFIED ARTHRITIS, MULTIPLE SITES (M13.89) 11/30/18 Secondary History OTHER SPECIFIED POSTPROCEDURAL STATES (Z98.890) 11/30/18 Secondary History T7-T8 laminectomy SPINAL STENOSIS, THORACIC REGION (M48.04) 11/30/18 Secondary History UNSPECIFIED ATRIAL FIBRILLATION (I48.91) 11/30/18 Secondary History UNSPECIFIED SEQUELAE OF UNSPECIFIED CEREBROVASCULAR DISEASE (I69.90) 11/30/18 Secondary History PNEUMONIA DUE TO METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (J15.212) 7/30/19 7/30/19 Other diagnosis 10+ RESTLESS LEGS SYNDROME (G25.81) 1/9/19 1/9/19 Other diagnosis 10+ During Stay MUSCLE WEAKNESS (GENERALIZED) (M62.81)",,"Nisoldipine, Latex","['Chest discomfort', 'Dyspnoea', 'Erythema', 'Feeling hot', 'Urticaria']",1,PFIZER\BIONTECH,IM 966333,IN,79.0,M,falling out of his wheelchair and having altered levels of consciousness every since receiving his COVID vaccine 2 days ago. Admitted with multiple pelvic fractures from fall and NSTEMI with elevated trop,Not Reported,,Not Reported,Yes,,Not Reported,U,01/20/2021,01/22/2021,2.0,SEN,"Current Outpatient Medications on File Prior to Encounter Medication Sig Dispense Refill ? acetaminophen (TYLENOL) 500 mg tablet Take 500 mg by mouth 4 (four) times daily at 8 am, 12 pm,4 pm, and 8 pm. Use caution with Acetaminophen total",none known,"past medical history of DM2, PNA, lung granulomas, HLD, HTN, ischemic cardiomyopathy s/p CABG, and PVD.",,NKA,"['Acute myocardial infarction', 'Altered state of consciousness', 'Aortic aneurysm', 'Arteriosclerosis', 'Bladder hypertrophy', 'Bladder injury', 'Computerised tomogram abnormal', 'Fall', 'Muscle oedema', 'Pelvic fluid collection', 'Pelvic fracture', 'Pelvic haemorrhage', 'Troponin increased', 'Urinary bladder haemorrhage']",UNK,MODERNA, 966359,IN,77.0,F,"Headache, pain in the injection site, threw up. A few hours later she died.",Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/20/2021,1.0,PUB,"Levothyroxine, Gabapentina, furosemide, Losartan, pravastatin","Diabetes, hyper tension",Diabetes,,Aleve,"['Death', 'Headache', 'Injection site pain', 'Vomiting']",1,MODERNA,SYR 966360,MD,30.0,F,"1 hour after receipt of booster vaccine, developed pruritis and difficulty breathing, throat tightness; Stridor evident in the ED, hypotension requiring epinephrine injections and eventual infusion.",Not Reported,,Yes,Yes,,Not Reported,Y,01/21/2021,01/22/2021,1.0,PVT,,,asthma,,augmentin cephalexin triclosan adhesive tape tramadol,"['Dyspnoea', 'Hypotension', 'Pruritus', 'Stridor', 'Throat tightness']",UNK,PFIZER\BIONTECH, 966379,TX,51.0,F,When I woke up the next morning I suffered from stomach pain .. Rushed to the hospital for an emergency surgery Diagnosed with Acute pancreatitis and had to have my Gallbladder removed Gal bladder was 13CM big Currently on Antibiotics,Not Reported,,Not Reported,Yes,6.0,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,Metformin 100 Mg Jardiance 10mg Ezetimite 5Mg Spironolactone 100 Mg Topamax 25Mg Zyrtec 10Mg Rossubastatin 5Mg Multi Vitamin,,Diabetes High Cholesterol Hemochromatosis,Flu Vaccine - Cellulitis 09/2020,Bactrim Lisinopril General Anesthesia,"['Abdominal pain upper', 'Aspartate aminotransferase', 'Cholecystectomy', 'Computerised tomogram', 'Magnetic resonance imaging', 'Metabolic function test', 'Pancreatitis acute', 'Ultrasound scan']",1,MODERNA,IM 966398,NJ,21.0,F,Patient began to have hives and required epinephrine and then 3.5 hours later required the same treatment and admission for further monitoring.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/21/2021,01/21/2021,0.0,PVT,"Lexapro, Birth Control, Vitamin C",None,Elhers Dandos,,"Peanuts, Tree Nuts, and Shellfish","['Laboratory test', 'Urticaria']",1,PFIZER\BIONTECH,IM 966399,MT,49.0,M,severe tinnitus and loss of hearing as some tones. persistent since day after vaccination and continuing through time of reporting to VAERS.,Not Reported,,Not Reported,Not Reported,,Yes,N,12/28/2020,12/29/2020,1.0,OTH,"lisinopril 40mg, vitamin d3, cetirizine 10mg",none,"hypertension, mild tinnitus",,none,"['Condition aggravated', 'Deafness', 'Tinnitus']",1,MODERNA,IM 966419,SD,67.0,M,Patient was given the COVID Pfizer vaccine at approximately 11:45 AM. Patients only allergy listed on VAR form is latex. Patient confirmed only latex allergy after having reaction. At 12:55pm a nurse at the facility altered the pharmacist and stated the patient was red and itchy and she had just given Benadryl 50mg. Patient's arms below the elbows were red and there were two hives on the arm that he received the vaccine in. Patients face was red as well. Patient stated they felt like their chest was tight and they were having shortness of breath. I asked the patient when they started experiencing the itching and redness and he stated shortly after receiving the vaccination. At that time 911 was called. I asked the staff to get the patient to a lying position. Patient is immobile and they needed extra staff. Patient became more red and skin was blotchy and had more hives. Administered epipen into left thigh while patient was sitting in wheelchair at 1:07 pm. EMS arrived at 1:10 and more epinephrine was administered as well as albuterol and levalbuterol nebs. Patients breathing then improved. Patient was then transported to the hospital,Not Reported,,Not Reported,Yes,,Not Reported,U,01/22/2021,01/22/2021,0.0,SEN,unknown,unknown,unknown,,latex,"['Chest discomfort', 'Dyspnoea', 'Erythema', 'Immobile', 'Pruritus', 'Rash macular', 'Urticaria']",1,PFIZER\BIONTECH,IM 966449,NY,54.0,F,"hypoxia to 30%, only improved to 82% on Nonrebreather at 100%, intubated for hypoxic respiratory failure",Not Reported,,Yes,Not Reported,,Not Reported,,01/22/2021,01/22/2021,0.0,PVT,,Asthma,,,Latex,"['Endotracheal intubation', 'Hypoxia', 'Respiratory failure']",UNK,MODERNA, 966515,MN,60.0,M,"confused, hypertensive, very pale and sweaty 6 minutes after receiving vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/22/2021,01/22/2021,0.0,PVT,"Tylenol, amlodipine, aspirin, aspirin-Na bicarb, atorvastatin, calcium acetate, carvedilol, gemfibrozil, glipizide, lantus, lisinopril, metformin",,"hypertension, CKD on dialysis/ESRD, anemia of CKD",,NSAIDs - kidney disease,"['Confusional state', 'Hyperhidrosis', 'Hypertension', 'Pallor']",1,MODERNA,IM 966530,TX,95.0,F,"She began exhibiting seizure like activity, admitted to hospital and observation and since has returned to the facility.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/21/2021,01/21/2021,0.0,SEN,none,COVID-19 (12-23-2020 to -01-15-2021),"Hx of hypertension, GERD, Acute kidney injury",,Codiene and Morphine,"['Laboratory test', 'Seizure like phenomena']",1,PFIZER\BIONTECH,IM 966556,IL,56.0,F,"Patient received vaccine on 1/6. Patient started not feeling well on 1/8 in the evening. On 1/9 patient had several abdominal pain, nausea, and vomiting. She was taken to the emergency room where she was admitted to the hospital with a small bowel obstruction.",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/06/2021,01/08/2021,2.0,PUB,Metoprolol Potassium Hydrochlorothiazide Pentasa,,crohn's disease hypertension,,,"['Abdominal pain', 'Blood test', 'Computerised tomogram', 'Malaise', 'Nausea', 'Small intestinal obstruction', 'Vomiting']",UNK,MODERNA,IM 966606,,27.0,F,"Heart rate elevated to 150 and above, shortness of breath. Went to emergency room. Admitted with blood clot in lung. Previously had COVID in 2020, and we are unsure if this is related to previous illness.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/18/2021,01/18/2021,0.0,SEN,,,,,,"['Dyspnoea', 'Heart rate increased', 'Pulmonary embolism']",2,PFIZER\BIONTECH,IM 966645,TX,41.0,F,12/4/2020. Received Vaccine on 12/30/2020. Feeling unwell with abdomen cramping on 12/31 and 1/1. Positive urine pregnancy test on 1/2/2021. Borderline blood HCG level by doctor's office. It was determined eventually to be chemical pregnancy by the doctor.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/04/2021,5.0,WRK,Prenatal vitamin,none,none,,none,"['Abdominal pain', 'Exposure during pregnancy', 'Human chorionic gonadotropin positive', 'Malaise', 'Pregnancy test urine positive']",1,MODERNA,SYR 966670,WI,83.0,F,Moderna COVID-19 Vaccine EUA Pt found unresponsive with seizure at her skilled nursing facility. Pt had first dose of vaccine earlier in the afternoon prior to being found unresponsive and seizing.,Not Reported,,Not Reported,Yes,,Not Reported,U,01/21/2021,01/21/2021,0.0,SEN,,,"dementia, HTN, OSA, prior L MCA stroke, and Afib",,"Allergies: erythromycin, iodinated diagnostic agents, iodine, nitrofuratoin, penicillin","['Seizure', 'Unresponsive to stimuli']",1,MODERNA, 966779,CT,27.0,F,"Approx 3 -5 minutes after vaccine -redness and hives on both arms, chest, and face. Approximately 10 minutes after vaccine- cough, shortness of breath, tongue itchy, lips swelling. Epi pen in L thigh, 50 mg benedryl IM in R deltoid. Brought to emergency room, 1 liter normal saline, pepcid, solu-medrol, 25mg benadryl IV. D/c to home around noon. 1/22/2020- secondary anaphylactic reaction at 945am. Epi pen to r thigh, 50mg PO benadryl, 20mg prednisone. Drove to hospital ER received 1 liter of normal saline, pepcid, 25mg benadryl IV, 40mg prednisone. D/C at 3pm on prednisone taper.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,PVT,Singulair Synthroid,"Anaphylaxis 12/22/2020, 12/23/2020, 12/24/2020- new onset nut allergy",Hypothyroidism Asthma,,Tree nuts-anapylaxis Anise seed- anaphylaxis Erythromycin-swelling,"['Anaphylactic reaction', 'Cough', 'Dyspnoea', 'Erythema', 'Lip swelling', 'Tongue pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 966801,CA,55.0,F,"Aprox 8-10 hrs after vaccine chills/ rigors, extreme fatigue, body aches, abd pain at Crohns hotspots: @ 12hrs temp 102.6 F: @ 15hrs Oxygen desaturation 89-90%, weakness, extreme fatigue Seen at ED aprox 6PM on 1/9/21: CBC, chem panel, CT abd, CXR Continued to have low sats and was admitted to hospital on 1/10/21 adverse reaction to vaccine, Reactive airway, asthma excerbation discharged on 1/12/21",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,"Ibuprofen, Breo, Incruse, singulair, protonix, neurontin, xyzal, multivit","Crohns flare Early December lasted 1-2 weeks -sx pain, off and on diarrhea, mild bloody spotting","high cholesterol, Crohns, Asthma, arthritis",,"Metocarpine, sulfa, adhesive tapes, latex","['Abdominal pain', 'Asthenia', 'Asthma', 'Body temperature increased', 'Bronchial hyperreactivity', 'Chest X-ray', 'Chills', 'Computerised tomogram abdomen', 'Condition aggravated', 'Fatigue', 'Full blood count', 'Laboratory test', 'Oxygen saturation decreased', 'Pain']",2,PFIZER\BIONTECH,IM 966828,CA,31.0,F,Acute sensory-motor neuropathy symptoms. Appears consistent with a mild Gullian Barre Syndrome,Not Reported,,Not Reported,Not Reported,,Yes,N,01/16/2021,01/20/2021,4.0,WRK,trazodone qhs prn,none,none,,nkda,"['Acute motor-sensory axonal neuropathy', 'Electromyogram normal', 'Guillain-Barre syndrome']",2,PFIZER\BIONTECH,IM 966844,NM,76.0,M,"Patient is reported to have died at home, the day after his COVID test. Family member states that he did good the afternoon and evening after his COVID-19 injection, but that he started not feeling good the next day. The patient ""was having palpitations"". The family tried to convince him to go to the Emergency Room, but he refused. Patient died at home.",Yes,01/14/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,PVT,Unknown,DM II,DM II,,KNA,"['Death', 'Feeling abnormal', 'Palpitations']",1,MODERNA,IM 966845,MI,35.0,M,"24 hr after vaccine, I had fatigue and generalized body aches and left arm pain at site of injection. I took tylenol. Those stopped by the second day morning (day after vaccine). However, in the second morning ( day after vaccine) I started having pain on left side of neck and on Trapezius muscle on left shoulder blade - and had that pain for three more days. Range of motion for neck restricted for three days. All symptoms improved after four days. I took Lidocaine patch and Tylenol for neck and shoulder blade pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,PVT,None,None,sleep apnea,,none,"['Arthralgia', 'Fatigue', 'Injection site pain', 'Joint range of motion decreased', 'Myalgia', 'Neck pain', 'Pain']",1,PFIZER\BIONTECH,IM 966856,KY,90.0,F,"Patient is a 90-year-old female. She is a nursing home resident with and ongoing COVID 19 outbreak occurring . She has been diagnosed with corona virus on 1/4/21. She apparently has not eaten or drank anything in about a week. She was being hydrated at the nursing home with normal saline, but has failed to improve. She was sent to the ER and was admitted on 1/8/21 to hospital At no time during the hospital stay has she been more than minimal responsive. She need O2 for Comfort but on CXR and CT cardiopulmonary imagining was clear. Discharge note stated that he was requiring supplemental oxygen, but her chest x-ray on admission actually showed no acute cardiopulmonary disease. She was diagnosed with COVID-19 on 1/4/21. Most likely, this disease set her level of function back to the point that she was no longer eating and drinking, and she just overall rapidly declined after that. There was no evidence of an actual COVID pneumonia or pneumonitis. On 1/12/2021 family made patient a DNR and IVF were stopped and switched to comforted care. Patient expired 1/13/21",Yes,01/13/2021,Not Reported,Yes,6.0,Not Reported,N,12/31/2020,01/04/2021,4.0,SEN,Covid outbreak in the facility tested two week before negative.,unk,renal AND Alzheimer's,,unk,"['Bacterial test positive', 'Blood bilirubin increased', 'Blood creatinine increased', 'Blood glucose normal', 'Blood potassium decreased', 'Blood sodium increased', 'Blood urea increased', 'Chest X-ray normal', 'Computerised tomogram head abnormal', 'Computerised tomogram thorax normal', 'Coronavirus infection', 'Culture urine negative', 'Death', 'Decreased appetite', 'Fluid intake reduced', 'General physical health deterioration', 'Haematoma', 'Haemoglobin decreased', 'Hyporesponsive to stimuli', 'Nitrite urine absent', 'Platelet count normal', 'SARS-CoV-2 test positive', 'White blood cell count increased', 'White blood cells urine positive']",1,PFIZER\BIONTECH,IM 966874,MI,35.0,M,24 hrs after vaccine started having fatigue and feverish for one day - I took Tylenol and Motrin. Was feeling better the day after the symptoms started.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/15/2021,1.0,PVT,none,none,none,COVID Pfizer Dose 1 12/22/2020,none,"['Fatigue', 'Pyrexia']",2,PFIZER\BIONTECH,IM 966887,IA,31.0,F,"Miscarried at 7.5 weeks between vaccination #1 and #2. I do not believe the vaccine was a cause, however, it was recommended to report just in case. This was a second pregnancy, first miscarriage. EDD was 9-1-2021. First pregnancy was uncomplicated. Pregnancy tests were negative prior to receiving the first vaccine and then turned positive on 12-29-2020 (5 days after getting first vaccine.)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,01/16/2021,23.0,UNK,Prenatal,None,None,,Sulfa medication,['Abortion spontaneous'],1,MODERNA,IM 966888,NV,56.0,F,"At 04:30 on 1/22/2021, facility was notified of employee death at home.",Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,PVT,,,,,,['Death'],2,MODERNA,IM 966895,NY,41.0,F,"Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer vaccinedose #2 on left arm on 1/6/2021 at 11:15 am. The pain persisted and increased in intensity despite the use of topical and oral anti inflammatory medications. She was evaluated by an orthopedist on 1/18/2021 who performed various imaging studies and diagnosed the acute condition as left subacromial bursitis and tendinitis secondary to vaccine infiltration in the left shoulder bursa. The employee informed employee health director on 1/20/2021 and evaluated on same day. On physical exam, she had marked tenderness on the left arm at site of injection and moderate decrease range of motion of the left shoulder. She has been prescribed physical therapy sessions of left shoulder for eight weeks and is continued on daily analgesics. SARSCov-2 Ab IgG test done on 1/20/2021 is negative She will follow up with her orthopedist for further diagnostic tests and treatment.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/06/2021,01/06/2021,0.0,PVT,no,no,no,,no,"['Bursitis', 'Imaging procedure', 'Immediate post-injection reaction', 'Injected limb mobility decreased', 'Injection site extravasation', 'Injection site pain', 'Injection site reaction', 'Pain in extremity', 'SARS-CoV-2 antibody test negative', 'Tendonitis']",1,PFIZER\BIONTECH,IM 966929,MN,35.0,F,"Second vaccine 1/8/21: 10 hours post vaccine there was a 103 degree fever for 30 hours with sharp 9/10 muscle pain and partial awareness to time place and location. Fatigue and pain and nauseas and weakness continued up until day 5. At day 5 8pm: loss of sensation in feet and legs, unable to ambulate, day 6: hospitalized for 7 days. Currently in inpatient acute rehab to re learn how to walk. Sharp painful neuropathy ongoing.",Not Reported,,Not Reported,Yes,6.0,Yes,N,01/08/2021,01/13/2021,5.0,PVT,"Seroquel, lamictal, klonopin, Allegra, vitamin d",None,"Generalized Anxiety disorder, over active bladder",,NKDA,"['Asthenia', 'Disorientation', 'Fatigue', 'Gait inability', 'Myalgia', 'Nausea', 'Neuralgia', 'Neurological examination normal', 'Neuropathy peripheral', 'Pain', 'Pyrexia', 'Sensory loss']",2,PFIZER\BIONTECH,IM 966954,PA,38.0,F,"Itching, chest tightness, SOB, tingling lips, loss of voice. Administered 100mg of benadryl within 5 min of symptom onset followed by Epi Pen with call to 911. Paramedics transported to ED. Patient was admitted with anaphylaxis. Used Adverse Event Emergency Policy.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/22/2021,01/22/2021,0.0,OTH,Budesonide 1 MG/2ML Inhalation Suspension (PULMICORT) USE 1 VIAL VIA NEBULIZER TWICE A DAY Albuterol Sulfate (2.5 MG/3ML) 0.083% Inhalation Nebulization Solution (PROVENTIL) Inhale 1 Vial via nebulizer every 4 hours as needed for Wheezing,,"Non-Hospital Hematuria Urgency of urination OTHER Chronic maxillary sinusitis Status asthmaticus Allergic reaction caused by a drug Migraines Asthma, moderate persistent Latex allergy Drug allergy Allergic contact dermatitis due to adhesives Perennial allergic rhinitis with seasonal variation Coronavirus infection RSV infection Vocal cord dysfunction",,Almond oil Dupilumab xolair,"['Anaphylactic reaction', 'Aphonia', 'Chest discomfort', 'Dyspnoea', 'Paraesthesia oral', 'Pruritus']",1,MODERNA,IM 966976,CA,30.0,M,"Vaccine given at 3:15pm. Pt in observation area, had sudden onset stridor/wheezing and difficulty breathing at 3:28pm. Pt placed in a wheelchair and taken immediately into hospital ED department, arrived in ED at 3:29pm. Pt in sinus tach with O2 SAT 83% on RA, placed on O2 without change, intubated successfully x1 at 1550 and placed on 100% FiO2. Orogastric tube and foley catheter placed. Medications given: Decadron 10mg IV, Benadryl 50mg IV, Pepcid 20mg IV, Epinephrine (0.1%) 0.3ml SQ, Epinephrine IV infusion initiated at 0.05mcg/kg/min, Rocuronium 90mgIV, Etomidate 30mg IV, Racepinephrine (2.25%) 1.5ml inhalation x2, Propofol 5mcg/kg/min IV infusion, NS 0.9% x 1 liter IV, Potassium Chloride 20mEq, Versed 2mg IV. Pt had own Epipen which was noted by ED MD as being used in ED. Pt admitted to CCU, extubated within 2-3 hours per pt request (per CCU RN) and placed on BiPAP. BiPAP weaned overnight and patient on room air by morning with SATs in the upper 90's. Weaning of Epinephrine infusion in progress. Projected outcome: pt to be discharged tomorrow (1/23/21) from CCU to home (per CCU RN).",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/21/2021,01/21/2021,0.0,PVT,None stated/Denied,None stated/Denied,None stated/Denied,"Unknown, but post extubation, pt stated he had a previous reaction with intubation required.",None stated/Denied,"['Bilevel positive airway pressure', 'Bladder catheterisation', 'Blood potassium decreased', 'Dyspnoea', 'Endotracheal intubation', 'Gastrointestinal tube insertion', 'Intensive care', 'Sinus tachycardia', 'Stridor', 'Wheezing']",1,PFIZER\BIONTECH,IM 966991,CA,81.0,M,One week after first Covid vaccine I was diagnosed with atrial fibrillation. Needed treatment. Four hours after second Covid vaccine atrial fibrillation recurred,Not Reported,,Yes,Yes,6.0,Not Reported,N,12/22/2020,12/29/2020,7.0,PVT,"Atorvastatin, vitamin D, multivitamins,",None,Osteoarthritis,,None,"['Atrial fibrillation', 'Blood test', 'Cardiac ablation', 'Cardioversion', 'Electrocardiogram']",1,MODERNA,IM 967071,MA,81.0,F,"severe back and leg pain, paresthesias bilaterally",Not Reported,,Not Reported,Yes,,Not Reported,N,01/04/2021,01/05/2021,1.0,SEN,,,,,,"['Back pain', 'Lumbar spinal stenosis', 'Lumbosacral radiculopathy', 'Neurological examination abnormal', 'Pain in extremity', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 967091,MO,61.0,M,"Within 8 hours of the vaccine I was experiencing a right sided headache, sharp shooting; aches; fatigue and mucousy diarrhea. The right sided headache continued for days. On Saturday evening Jan 16th it became the worst headache of my life. Like a fool I didn't go to ER until Monday morning when I developed left handed weakness. I was visiting my son and presented to the Medical Center ER where I was diagnosed with an acute sub-dural brain bleed and airlifted to Specialized Hospital. Was admitted to the Neuro-Neurosurgery Unit.",Not Reported,,Not Reported,Yes,,Not Reported,,01/08/2021,01/09/2021,1.0,UNK,"Metoprolol xl, warfarin, atorvastatin, aspirin, famotidine,",none,"Hypertension, Hyperlipidemia, GERD, Hx of PEs, Seasonal allergies, VitaD Deficiency",,NKDA,"['Angiogram cerebral abnormal', 'Computerised tomogram head abnormal', 'Diarrhoea', 'Fatigue', 'Headache', 'Muscular weakness', 'Pain', 'Subdural haemorrhage']",1,MODERNA,IM 967214,WI,88.0,F,"Within 1/2 hour of vaccination the patient was dizzy and was having a hard time remaining upright, additionally the patient was less alert and oriented. Patient was observed for a few minutes and then ambulance was called. Patient was transported via EMS within an hour of being vaccinated to local hospital. Patient was found to have has had major stroke and is presently in ICU and not expected to make it.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/21/2021,01/21/2021,0.0,SEN,"aspirin, atorvastatin, famotidine, gabapentin, metoprolol, omeprazole, tramadol",unknown,"anemia, monoplegia of lower limb affecting right dominant side, encephalopathy unspecified, atherosclerotic heart disease, cardiomyopathy, barrets esophagus, acute kidney failure",,sulfa,"['Cerebrovascular accident', 'Depressed level of consciousness', 'Disorientation', 'Dizziness', 'Dysstasia', 'Intensive care']",UNK,MODERNA,IM 967240,MN,47.0,M,Patient unexpectedly died on o1/6/2020. No known signs or symptoms.,Yes,01/06/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 967632,HI,87.0,F,Respiratory distress Hypertension,Not Reported,,Not Reported,Yes,,Not Reported,,01/18/2021,01/21/2021,3.0,UNK,,,,,,"['Hypertension', 'Respiratory distress']",UNK,PFIZER\BIONTECH,IM 967753,,88.0,U,"lightheadedness, generalized weakness (inability to ambulate), decreased appetite Narrative: Pt is currently hospitalized on oxygen being treated for COVID-19 (remdesivir, dexamethasone and Lasix)",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/12/2021,01/13/2021,1.0,OTH,,,,,,"['Asthenia', 'COVID-19', 'Decreased appetite', 'Dizziness', 'Gait inability', 'SARS-CoV-2 test positive']",1,MODERNA,IM 967274,NY,27.0,F,I was pregnant and my baby died two days after I took it and I got really sick,Not Reported,,Yes,Yes,2.0,Yes,N,01/01/2021,01/06/2021,5.0,PVT,None,No,No,,No,"['Exposure during pregnancy', 'Foetal death', 'Malaise', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 967286,CA,44.0,M,"s/p vaccination with 2nd Covid Vaccine dose, developed low grade viral type illness with fevers up to 102 with myalgias, fatigue. Began to recover, teh awoke in the morning of 1/16/20 wtih crushing, substernal chest pain. Presented to the emergency department. Was admitted to he hospital - diagnosed with myopericarditis. Stayed in the hospital one night, and discharged the next day.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/13/2021,01/16/2021,3.0,PVT,,,"dysplipdemia, pre-diabetes, obesity, OSA, s/p COVID infection 8/2/20",,,"['C-reactive protein increased', 'Chest pain', 'Electrocardiogram PR segment depression', 'Electrocardiogram PR segment elevation', 'Electrocardiogram ST segment elevation', 'Fatigue', 'Myalgia', 'Myocarditis', 'Pyrexia', 'Red blood cell sedimentation rate increased', 'Troponin increased', 'Viral infection']",2,PFIZER\BIONTECH,IM 967326,FL,49.0,F,"20 minutes post injection- generalized redness of skin, felt hot and flushed. 25 minutes - tachycardia heart rate. Went from 60?s to 120?s. 30 minutes- difficulty swallowing and hypoxia @ 90",Not Reported,,Not Reported,Not Reported,,Yes,N,12/26/2020,12/26/2020,0.0,PVT,"NP Thyroid 90mg daily vitamin D3 10,000 daily Vitamin C 2000 daily Progesterone 100mg HS",None,Hypothyroid controlled by medication,,Sulfa- childhood rash,"['Dysphagia', 'Erythema', 'Feeling hot', 'Flushing', 'Hypoxia', 'Tachycardia']",1,MODERNA,IM 967327,CO,81.0,M,"EMS brought patient to ED stating patient was bright red and tachypneic with oxygen saturation of 81-82% on RA. Failed on CPAP. Given Benadryl 50mg IVP, Solumedrol 125mg IVP, 0.3mg of IM Epi and a duoneb with no relief. Was RSI'd and intubated and transported to the ED.",Not Reported,,Yes,Yes,,Not Reported,N,01/22/2021,01/23/2021,1.0,OTH,Prednisone 10mg daily; Finasteride 5mg daily; Omeprazole 40mg daily; Simvastatin 40mg q hs; Advair Diskus 250mg/50 bid; Spiriva 18mcg inhalation daily.,Unknown,"Anemia, BPH, GERD, Chronic Pulmonary Hypertension, COPD, CVA, DMT2, Dyslipidemia, Hyperlipidemia, Lower Respiratory Infection, Pneumonia, Rheumatic Fever, Shingles and Urinary Frequency.",,Cefdinir and Tamsulosin,"['Base excess', 'Blood bicarbonate increased', 'Blood culture', 'Blood glucose normal', 'Blood lactic acid', 'Blood pH decreased', 'Blood sodium increased', 'Blood urine present', 'Carbon dioxide normal', 'Chest X-ray abnormal', 'Computerised tomogram thorax', 'Continuous positive airway pressure', 'Endotracheal intubation', 'Erythema', 'Fibrin D dimer', 'Glomerular filtration rate decreased', 'Lung infiltration', 'Lymphocyte count', 'Monocyte count decreased', 'Monocyte count increased', 'Neutrophil percentage decreased', 'PCO2 increased', 'PO2 increased', 'Pulmonary oedema', 'Red blood cell count decreased', 'Red cell distribution width increased', 'Tachypnoea', 'Urine analysis abnormal', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 967399,TN,56.0,M,Sudden death,Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/21/2021,9.0,PVT,,No,diabetes,,No,['Sudden death'],2,PFIZER\BIONTECH,IM 967477,TN,42.0,F,"Day 1. Fatigue. Sleepiness. Loss of appetite Day 2. Muscle aches. Headache. Chills. Loss of appetite. Episode of severe abdominal pain, chest pain, right shoulder pain, shortness of breath, syncope, diaphoresis, vomiting Day 3. Fatigue. Headache. Chest pain.",Not Reported,,Yes,Not Reported,,Not Reported,U,01/20/2021,01/20/2021,0.0,PVT,Sertraline Nexium Vitamin D Melatonin,None,Depression Anxiety Migraines GERD,,Cinnamon Promethazine,"['Abdominal pain', 'Arthralgia', 'Chest pain', 'Chills', 'Decreased appetite', 'Dyspnoea', 'Electrocardiogram normal', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Laboratory test', 'Myalgia', 'Somnolence', 'Syncope', 'Vomiting']",2,PFIZER\BIONTECH,IM 967498,CA,24.0,F,"Severe shoulder pain, limited mobility, arm weakness still from the first day of injection (1/14) to now (1/23). Can?t adduct arm or move it side to side with out a lot of pain. If I do a wrong movement I will end up in 10/10 pain with severe aches.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/01/2021,01/01/2021,0.0,WRK,,Covid with symptom onset of December 20th and ending December 28th,,,,"['Arthralgia', 'Mobility decreased', 'Muscular weakness', 'Pain', 'X-ray normal']",1,MODERNA,SYR 967506,TX,73.0,M,Died within 5 days of receiving vaccine. Exact cause and day unknown.,Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/01/2021,,UNK,"Ketoconazole, lisinoprol, atravastatin, xarelto, bupropion, sertraline",,Congestive heart failure,,,['Death'],1,MODERNA, 967521,MA,39.0,F,Sever abdominal pain that started 1/21 at 9pm. Persisted overnight. Went to ER at 930am on 1/22. Diagnosed with appendicitis. Appendectomy surgery performed around 7pm on 1/22/21.,Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/11/2021,01/21/2021,10.0,PVT,Low estrin Vitamin E B-complex,None,None,,None,"['Abdominal pain', 'Appendicectomy', 'Appendicitis', 'Computerised tomogram abdomen', 'Computerised tomogram pelvis', 'Full blood count', 'Liver function test', 'Metabolic function test', 'Urine analysis']",1,MODERNA,IM 967529,PA,44.0,F,At 6:45AM on 1/19/21 patient developed numbness and tingling on right side of body which progressed to right hemiparesis and right-sided facial droop. Brought to ED by EMS and worked up for stroke. Found to have acute infarct on MRI and treated with dual antiplatelet therapy.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/15/2021,01/19/2021,4.0,UNK,Levothyroxine tablet,,Hypothyroidism,,Latex - sensitivity,"['Basal ganglia infarction', 'Cerebral infarction', 'Computerised tomogram head normal', 'Computerised tomogram neck', 'Facial paralysis', 'Fibrin D dimer increased', 'Hemiparesis', 'Hypoaesthesia', 'Magnetic resonance imaging brain abnormal', 'Paraesthesia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 967560,OH,88.0,M,within 15 min of receiving Covid-19 Moderna vaccine pt C/O: chest pain and heart palpitations. Vitals 100/60 P: 80 Regular. Learned later from family member that patient was taken to hospital and admitted.,Not Reported,,Not Reported,Yes,,Not Reported,U,01/20/2021,01/20/2021,0.0,PUB,,"heart related issues, stents per daughter",cardiac,,,"['Chest pain', 'Palpitations']",1,MODERNA,IM 967588,NY,76.0,F,"fever up to 103, chills, aches, malaise, abd pain, vomiting, went to the ER had IVF abnormal labs, + non st elevation MI",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/18/2021,01/19/2021,1.0,PVT,"LISINOPRIL-HCTZ 10/12.5MG PO DAILY, VITAMIN D3 1000 UNITS PO DAILY TOPROL XL 12.5MG PO QHS ADVIAR 250/50MG BID CRESTOR 20MG PO DAILY",NONE,"HTN, HYPERLIPIDEMIS, LBBB, BREAST CANCER RIGHT LUMPECTOMY RADIATION AND CHEMO, ASTHMA, SPONDYLOSIS, LUMBAR STENOSIS",,SHELLFISH,"['Abdominal pain', 'Acute myocardial infarction', 'Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood alkaline phosphatase increased', 'Blood creatine phosphokinase increased', 'Chills', 'Malaise', 'Pain', 'Pyrexia', 'Troponin increased', 'Vomiting']",2,PFIZER\BIONTECH,IM 967589,NY,54.0,F,patient immediately got short of breath and hypoxic requiring intubation,Not Reported,,Yes,Yes,2.0,Not Reported,N,01/22/2021,01/23/2021,1.0,PVT,none,none,"asthma, sleep apnea",,none,"['Dyspnoea', 'Endotracheal intubation', 'Hypoxia']",1,MODERNA,IM 967643,NY,31.0,F,"After I had the 2nd dose of the Pfizer, my left arm was numb and couldn?t drive but I was able to live with it until the 4th day, during working period I suddenly felt dizzy and nauseous, went to throw up, dizziness was intense then I fell off my chair and was rushed to the Emergency for treatment, was treated for vertigo and given Meclizine to reduce the dizziness and nausea. Till date the dizziness wouldn?t go away.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/07/2021,01/11/2021,4.0,WRK,,,,,,"['Dizziness', 'Fall', 'Hypoaesthesia', 'Impaired driving ability', 'Nausea', 'Vertigo', 'Vomiting']",2,PFIZER\BIONTECH,SYR 967681,TX,38.0,M,"I am a physician myself and would like to report the following adverse event: - 2nd dose of Pfizer COVID 19 vaccine received on 1/8/21 - 1/9/21 Had body aches, chills, no fever, fatigue - relieved with Tylenol and ibuprofen and all resolved by 1/10. - On the night of 1/12/21, after an intense gym workout, I was unable to lay flat in bed. I had sudden onset SOB, chest tightness, audible upper airway wheezing. Symptoms persisted and worsened through the night prompting me to drive to the Emergency Dept.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/08/2021,01/12/2021,4.0,PVT,Atorvastatin 80 mg daily Ezetimibe 10 mg daily Amlodipine 5 mg daily Telmisartan 40 mg daily Sertraline 100 mg daily,None,"Hypertension, Hyperlipidemia",,NKDA,"['Angiogram pulmonary abnormal', 'Blood culture negative', 'Brain natriuretic peptide increased', 'C-reactive protein increased', 'COVID-19 pneumonia', 'Chest discomfort', 'Chills', 'Dyspnoea', 'Echocardiogram normal', 'Ejection fraction decreased', 'Fatigue', 'Fibrin D dimer normal', 'Haemoglobin decreased', 'Interleukin level', 'Pain', 'Platelet count normal', 'Pleural effusion', 'Procalcitonin increased', 'Pulmonary oedema', 'Respiratory viral panel', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 antibody test positive', 'SARS-CoV-2 test negative', 'Troponin increased', 'Wheezing', 'White blood cell count normal']",2,PFIZER\BIONTECH,IM 967802,MA,58.0,M,"Chest pain, leading to STEMI",Not Reported,,Yes,Yes,,Not Reported,U,01/21/2021,01/21/2021,0.0,PVT,"Aspirin 81mg daily, ginseng, garlic, grapeseed","Raynaud's, hypertension, hyperlipidemia","Raynaud's, hypertension, hyperlipidemia",,No allergies,"['Acute myocardial infarction', 'Chest pain']",2,MODERNA,IM 967816,IA,65.0,F,"Enable to make sleep headaches ,GI,elevated temp.and extreme fatigue ,rapid heartbeat",Not Reported,,Not Reported,Yes,2.0,Not Reported,,,,,PUB,"Prior to event daily ferrous sulfate,folic acid Vitamin D3,fexofenadine, hydroxyzine Lumigan ,prolia Q 6months",No,None,,Codeine phosphate hydrocodone Zpak Formaldehyde,"['Body temperature increased', 'Fatigue', 'Gastrointestinal disorder', 'Headache', 'Heart rate increased', 'Hypertension', 'Sleep disorder']",1,MODERNA,SYR 967821,NC,25.0,F,"Full right side paralyzed, facial pain, shooting body pain",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/21/2021,01/21/2021,0.0,PVT,None,No,No,,"Zofran, morphine","['Computerised tomogram head normal', 'Facial pain', 'Hemiplegia', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging neck', 'Pain']",1,MODERNA,IM 967830,CA,64.0,M,"Patient was was brought to the ED from facility which he received the vaccine via ambulance with BiPAP, hypoxia, and one dose of Epi of 0.3 mg. He then required intubation, and had struggled with hypoxia, even on increasing PEEP. CODE BLUE called in the ED for PEA. He was medicated for such (please see the code run sheet for details), and he came in and out of the code 5 times. After 95 minutes, with the wife at the bedside, and family conference by phone, the code was called, and he was pronounced at 18:20. He received in total 8 me of Epi, 3 shots of Atropine, 3 amps bicarb. He got lasix 40 mg, lovenox 60 mg subcutaneous once. He had a CVC into the right internal jugular, and levophed was started, then Epinephrine drip was started. Prior to the code he got steroids (solumedrol 125 mg, then later decadron 6 mg iv), benadryl iv, antibiotics (ceftraixone / zithromax), and lasix 40 mg. All this time while in the ED, the Rt was at the bedside, and lots of secretions from the lungs were aspirated, bloody color. � Code was the result of PEA secondary to hypoxia ( 100.4F 2) BISACODYL SUPP,RTL 10MG RTL DAILY PRN hold for >1 BM daily 3) BISACODYL TAB,EC 10MG PO DAILY PRN FOR CONSTIPATION, second line 4",Cholecystitis,"Gout, low back pain, knee pain, constipation",,NKDA,"['Cholecystitis infective', 'Computerised tomogram abnormal', 'Condition aggravated', 'Escherichia bacteraemia', 'Laparoscopic surgery', 'Pulmonary embolism', 'Sepsis']",1,MODERNA,IM 971645,IL,65.0,F,"A few hours after the vaccine was administered, patient experienced increased shortness of breath. Baseline O2 requirement is usually 2-3 Liters; required 7L on home O2. Was using nebulizers 2-3 times a day afterward as well (typically uses 1-2 times a month). Patient does not have history of COPD exacerbations that present similarly. Presented to the emergency department and now admitted to the ICU.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/23/2021,01/23/2021,0.0,PVT,,,"COPD (baseline O2 requirement 2-3 Liters), HFpEF, HTN, T2DM,",,"Penicillin, Shellfish, Aspirin","['Dyspnoea', 'Intensive care']",1,PFIZER\BIONTECH,IM 971656,GA,47.0,F,"Pain in left arm. Several days later, chest pain, pain on left side of back. Left wrist pain. All would come and go. January 7, bottom lip began tingling and left side of face went numb. Taken to medical center and admitted.",Not Reported,,Yes,Yes,1.0,Not Reported,N,12/30/2020,01/01/2021,2.0,PUB,"Prozac, Norvasc, Elderberry, Vitamin C, D3, Turmuric, Multivitamin, Vyvanse",None,None,,KNA,"['Arthralgia', 'Back pain', 'Blood test', 'Chest pain', 'Computerised tomogram', 'Electrocardiogram', 'Hypertension', 'Hypoaesthesia', 'Magnetic resonance imaging', 'Pain in extremity', 'Paraesthesia oral', 'Scan myocardial perfusion', 'X-ray']",1,MODERNA,SYR 971665,OK,64.0,M,"Left side of face paralysis, primarily noted in mouth and left eye. Can not blink left eye, continues to tear up. Left side of mouth does not move while trying to smile/eat/talk. Emergency Room visited 1/24/20. MRI, CT Scans run to determine if stroke occurred. Diagnosis is Bells Palsy with seven days of steroids prescribed (Prednisone 20mg - two tabs once per day).",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/19/2021,01/24/2021,5.0,OTH,"Lisinopril 40mg, Amlodipine 5mg, Hydroclorothiazide 25mg, Allopurinol 300mg, 81mg Asprin",none,"High Blood Pressure - treated with medication above. Obesity (5'8"" - 315 lbs.)",,"None that I am aware of, or has occurred in the past.","['Computerised tomogram normal', 'Eyelid function disorder', 'Facial paralysis', 'Lacrimation increased', 'Magnetic resonance imaging normal']",1,MODERNA,IM 971676,IA,82.0,F,muscle aches-increased pain to lower back,Yes,01/19/2021,Not Reported,Yes,13.0,Not Reported,N,12/31/2020,01/01/2021,1.0,SEN,"Tylenol, aleve, aspirin, bisacodyl, calcium carb-cholecalciferol, diclofenac, fluticasone-Salmeterol inhaler, hydromorphone, hycacyamine sulfate, ketoconazole cream, levemir, lidocaine patch, lisinopril, mematine, methcarbamol, metoprolol,","HYPERLIPIDEMIA, UNSPECIFIED(E78.5), CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED(J44.9), VASCULAR DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE(F01.50), OTHER SPECIFIED ANXIETY DISORDERS(F41.8), VENTRAL HERNIA WITHOUT OBSTRUCTION OR GANGRENE(K43.9), NONINFECTIVE GASTROENTERITIS AND COLITIS, UNSPECIFIED(K52.9), CHRONIC VASCULAR DISORDERS OF INTESTINE (K55.1), SACROCOCCYGEAL DISORDERS, NOT ELSEWHERE CLASSIFIED(M53.3), OTHER SPECIFIED DISORDERS OF BONE DENSITY AND STRUCTURE, UNSPECIFIED SITE(M85.80), PERSONAL HISTORY OF OTHER VENOUS THROMBOSIS AND EMBOLISM(Z86.718), PRESENCE OF INTRAOCULAR LENS(Z96.1), ANEMIA, UNSPECIFIED(D64.9), DISORDER OF WHITE BLOOD CELLS, UNSPECIFIED(D72.9), IRRITABLE BOWEL SYNDROME(K58), ABDOMINAL AORTIC ANEURYSM, WITHOUT RUPTURE(I71.4), PAIN IN RIGHT ANKLE AND JOINTS OF RIGHT FOOT(M25.571), TYPE 2 DIABETES MELLITUS WITH DIABETIC PERIPHERAL ANGIOPATHY WITHOUT GANGRENE(E11.51), ACUTE HEMATOGENOUS OSTEOMYELITIS, OTHER SITES(M86.08), ESSENTIAL (PRIMARY) HYPERTENSION(I10), GROSS HEMATURIA(R31.0), MAJOR DEPRESSIVE DISORDER, RECURRENT, UNSPECIFIED(F33.9), CHRONIC KIDNEY DISEASE, STAGE 2 (MILD)(N18.2), WEDGE COMPRESSION FRACTURE OF T11- T12 VERTEBRA, SUBSEQUENT ENCOUNTER FOR FRACTURE WITH ROUTINE HEALING(S22.080D), PERIPHERAL VASCULAR DISEASE, UNSPECIFIED(I73.9), BODY MASS INDEX [BMI]40.0-44.9, ADULT(Z68.41), HYPERMETROPIA, BILATERAL(H52.03), OTHER MYELODYSPLASTIC SYNDROMES(D46.Z), MUSCLE WEAKNESS (GENERALIZED)(M62.81",see #11,,"hydrocodone, metformin, niacin, Aricept, lipitor","['Back pain', 'Myalgia']",1,PFIZER\BIONTECH,IM 971736,IA,88.0,M,"Vomit 30 minutes after administration. approx. 9 hours later, resident has Stroke-like symptoms. He was previously on Hospice before admitting to our facility and planned to be readmitted to hospice upon discharge.",Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,SEN,"acetaminophen, aspirin, atorvastatin, bicalutamide, Plavix, lisinopril, metoprolol, multivitamin, oxycodone, Seroquel, sertraline, vanicream","DISPLACED INTERTROCHANTERIC FRACTURE OF LEFT FEMUR, SUBSEQUENT ENCOUNTER FOR CLOSED FRACTURE WITH ROUTINE HEALING (S72.142D), MALIGNANT NEOPLASM OF PROSTATE(C61), UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE(F03.90), ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS(I25.10), DISPLACED FRACTURE OF BASE OF NECK OF RIGHT FEMUR, SUBSEQUENT ENCOUNTER FOR CLOSED FRACTURE WITH ROUTINE HEALING(S72.041D), ESSENTIAL (PRIMARY) HYPERTENSION(I10), ANEMIA, UNSPECIFIED(D64.9), HYPOKALEMIA(E87.6), ST ELEVATION (STEMI) MYOCARDIAL INFARCTION OF UNSPECIFIED SITE(I21.3), MAJOR DEPRESSIVE DISORDER, RECURRENT, UNSPECIFIED(F33.9), HYPERLIPIDEMIA, UNSPECIFIED(E78.5), ALZHEIMER'S DISEASE WITH LATE ONSET(G30.1), OTHER ABNORMALITIES OF GAIT AND MOBILITY(R26.89), DISORIENTATION, UNSPECIFIED(R41.0), MUSCLE WEAKNESS (GENERALIZED)(M62.81), DYSPHAGIA, OROPHARYNGEAL PHASE(R13.12)",see #11,,"terbinafine, ACE inhibitors, tetanus toxoids","['Neurological symptom', 'Vomiting']",1,PFIZER\BIONTECH,IM 971749,ME,39.0,F,"1 week after receiving the first dose, in the afternoon i had loose stool followed by some mild abdominal cramping for the rest of the day. I took some ibuprofen. The following morning (Wednesday), the pain was on my right abdomen and right flank area only. It was persistent, achy, soreness. My insides felt very tender to put any pressure on my right abdomen or flank. The pain on the right side of my back became more intense as the day went on. I had sharp right flank pain when lifting my right leg after showering to get dressing and use lotion. When I was walking up the stairs I turned to the left and had a sharp pain in the right flank again, taking my breath away for a moment. Around 4pm I took ibuprofen. About an hour later my eyes felt hot and tired. My cheeks were pink. My temp was 99.2. I generally just didn't feel good from this achiness. I took Benadryl and went to bed at 7pm, and slept for about 12 hours, waking once at midnight. The following day (Thursday) I felt 99% better and contacted my doctors office. When putting pressure on the same areas I could feel very slight tenderness if I pushed hard. That evening and into the next morning (Friday) I was mildly achy on my right side but barely at all. I didn't feel any more discomfort until this past week on the 22nd or 23rd. During sexual intercourse I felt that same mild internal tenderness on my right side. At this time, I don't believe I have any pain. My urine seems unusually clear, light colored, and smaller volume but this is very subjective. I have some abdominal swelling but this has been present since my breast reconstruction in January of 2020 and seems to get worse or better depending on the days activities or meals so it's hard to know what causes what. Labs were done on 1/22 showing decreased kidney fuction. Pending tests include an ultrasound of the Right Ovary that remains after the hysterectomy, bladder, and kidney. In addition to a 24 hour urine and some other urine studies.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/05/2021,01/12/2021,7.0,WRK,"D-Mannose had been taken a couple times the week prior. 1000mg in the morning, maybe 4 times.","some urinary difficulties and urinary tract infections since hysterectomy in 05/2020 which resulted in a bladder puncture that was repaired intra-op. Week prior to vaccine, UTI symptoms such as cloudy urine and urgency were present. Weekend prior to vaccine, hormonal symptoms were present such as PMS and hormonal acne.","Non-allergic rhinitis Micro invasive breast cancer diagnosed in 10/2019. Bilateral mastectomy with reconstruction and hysterectomy in 2020 (no chemo, radiation, or hormone treatment). Raynaud's disease of upper and lower extremities. Family history of vascular connective tissue disorders (aortic dissection in father and grandmother). Raynaud's in other family members. Mononucleosis during childhood. Chicken pox at 6 months old. Shingles at 24 years old; left-side back of neck. Long-term hyperreactive inflammatory responses that has not been worked up.",,"Non-allergic rhinitis which results in nasal congestion and sneezing to many foods and scents. Keflex, Sulfa (full body hives); history of moderate responses to bee stings. Systemic reactions to poison ivy and poison sumac. Skin sensitivities to adhesives such as surgical glue (hives), steristrips (blisters and itching), Surgical drapes (rash), silicone scar tape (blisters). Sensitivities to ultram (blurred vision), Demerol/Vistaril (migraine/brain fog/visual changes), fentanyl (itching)","['Abdominal pain', 'Abdominal tenderness', 'Abnormal sensation in eye', 'Asthenopia', 'Back pain', 'Blood creatinine increased', 'Body temperature increased', 'Diarrhoea', 'Discomfort', 'Erythema', 'Feeling abnormal', 'Flank pain', 'Glomerular filtration rate decreased', 'Metabolic function test', 'Pain', 'Renal impairment']",1,PFIZER\BIONTECH,IM 971758,FL,24.0,M,"Reported that within 2 minutes of receiving vaccine,began to experience a swelling feeling in his throat.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,PVT,None,None,None,,"Sulfa drugs, seafood",['Pharyngeal swelling'],UNK,MODERNA,IM 971796,AL,50.0,M,The patient became short of breath and decreased oxygen saturation at home around 2000 on 01/18/2021. He reported to the ED on 01/19/2021 at approximately 0500. The patient was found to have bilateral pulmonary emboli.,Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,01/18/2021,01/18/2021,0.0,PVT,Denies,COVID 19 positive on 01/04/2021,None Reported,,No Known Allergies,"['Blood test', 'Chest X-ray', 'Computerised tomogram thorax abnormal', 'Dyspnoea', 'Oxygen saturation decreased', 'Pulmonary embolism']",1,MODERNA,IM 971798,DC,76.0,F,"VACCINE received on Friday 1/15/2021 afternoon; Monday evening 1/18/2021 felt slight chills; early to bed. Tuesday AM awoke with severe 'bed-rocking' chills, nausea and fever 100-101 degrees. recommended I go to Hospital ER. At ER, temperature increased to 102 degrees. Covid test was negative, but cost X-ray showed reasons to suspect pneumonia. No one suggested I was just suffering acute reaction to vaccine. Returned home w/ prescription for doxycycline hyclate and request that I return to the ER the next day if I continued to feel ill. The next morning, 1/19/21, I again awoke with intense, somewhat frightening chills, vomiting and a mild fever. As instructed I returned to the ER. Assuming the COVID Test may have been a false negative, a second one was given; it too turned out to be negative, but I remained at the ER and then admitted to Hospital to remain under observation. Im the hospital the chills, nausea and fever came to an end, but acute headache and utter fatigue lasted until I was released on Jan 22. My discharge papers indicated no further signs of pneumonia or any other infection; my attending doctor, concluded that my experience was an unusually strong (and delayed) reaction to the 1st dose of the Moderna Vaccine.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/15/2021,01/18/2021,3.0,OTH,Nitrofurantoin mono-MCR 100 MG PANTOPRAZOLE 40 MG FISH OIL flax oil,None,None,,NONE,"['Blood test', 'Chills', 'Computerised tomogram', 'Fatigue', 'Headache', 'Nausea', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test negative', 'Urine analysis', 'Vomiting', 'X-ray abnormal']",1,MODERNA,IM 971813,AL,85.0,F,"patient received vaccine on 1/20/2121, later that night husband found her slumped in chair, called EMS and patient was taken to Hospital where she died on 1/21/2021",Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,PUB,not known,"A fib, type 2 diabetes, HTN, seizure disorder, CHF","A fib, type 2 diabetes, HTN, seizure disorder, CHF, Z alpha hydroxylase deficiency",,Iodine,"['Death', 'Posture abnormal']",1,MODERNA,IM 971865,TN,67.0,F,"PATIENT RECEIVED VACCINE 1/12/2021. STATES SHE WOKE AT 0500 ON 1/21/2021 WITH SEVERE BURNING AND ITCHING AT INJECTION SITE, STATES ARM SWOLLEN TO GRAPEFRUIT SIZE. WENT TO PCP WHERE SHE WAS ADMINISTERED A STERIOD INJECTION AND PUT ON BENADRYL PO. RESOLVED ON 1/25/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/21/2021,9.0,PUB,"UNKNOWN NAME MEDICATION FOR HTN, CHOLESTEROL, THYROID DISEASE, OTC VITAMINS, AMBIEN",NONE,"HYPERTENSION, HYPERLIPIDEMIA, INSOMNIA, THYROID DISEASE",,SULFA,"['Injection site pain', 'Injection site pruritus', 'Peripheral swelling']",1,MODERNA,IM 971918,NE,75.0,M,"Patient presented to the ED with altered mental status and extreme agitation. Patient was given lorazepam 1 mg IV, haloperidol 5 mg IM, and Olanzapine 5 mg IM. Patient's quetiapine was also increased. Infectious workup was negative besides elevated temperature. Patient's agitation had resolved by the next morning 01/21 but was still experiencing AMS. By 01/23 patient had seen marked improved mental status and fever free for > 24 hours.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/19/2021,01/20/2021,1.0,PHM,"Tylenol, allopurinol, aspirin, atenolol, docusate, benadryl, lisinopril, lorazepam, melatonin, metformin, Myrbetriq, mirtazapine, nyamyc pwd, fish oil, oyster shell calcium, quetiapine, simvastatin, Toujeo, Thera-M multivitamin, vit D3","No new dx but ALF nursing staff did notice more anxiety in patient in week prior to hospitalization. COVID + test 2 weeks prior to vaccination. Follow up tests were negative, and first positive was ruled a false +","Cognitive Disorder, essential HTN, CKD stage 3, dyslipidemia, gout, T2DM, Paranoid schizophrenia, MDD recurrent, proteinuria",,None,"['Agitation', 'Body temperature increased', 'Chest X-ray abnormal', 'Computerised tomogram abnormal', 'Inguinal hernia', 'Laboratory test normal', 'Mental status changes', 'Procalcitonin increased']",1,MODERNA,IM 971923,RI,55.0,F,"Was sitting for observation, around 5 minutes later starting coughing and getting flushed in the face and saying it was getting hot. Then, continued to cough and was using her prescribed inhaler ( unknown what type of inhaler it was ). Administered epi-pen immediately, and called 9-1-1. Had to administer second epi-pen 5 minutes later, and patient also took two 25 mg benadryls. A nurse at the facility was the one to administer her epi-pens. They were the patient's prescribed epi-pens",Not Reported,,Not Reported,Yes,,Not Reported,U,01/25/2021,01/25/2021,0.0,SEN,,,,,contrast dye and nuts were stated at time of vaccination,"['Cough', 'Feeling hot', 'Flushing']",1,PFIZER\BIONTECH,IM 971939,WA,43.0,F,"Parsonage-turner syndrome, confirmed by neurologist and primary care provider. 5 days after 2nd dose, the patient developed severe pain around vaccination site and arm, followed by muscle atrophy, weakness and clinical signs consistent with acute brachial neuritis.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/17/2020,01/05/2021,19.0,PVT,None,None,None,,None,"['Asthenia', 'Muscle atrophy', 'Neuralgic amyotrophy', 'Pain in extremity', 'Radiculitis brachial', 'Vaccination site pain']",1,PFIZER\BIONTECH, 971969,LA,72.0,F,brought by EMS to ED; seizures at home in bed; 6 Epi and 1 bicarb; no hx of seizure,Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/21/2021,6.0,PVT,,,"HTN, BCC, HLD",,NKA,['Seizure'],1,PFIZER\BIONTECH,IM 971989,TX,70.0,M,"Following are my symptoms and severe side effects and events after receiving the COVID-19 Vaccine. 1- Receive COVID 19 vaccine at 4.00 PM on 01/15/21. 2- Stay about 20 minutes after Vaccination and observe no reactions and symptoms. Dive back home. take dinner and sleep well whole night. 3- Next day morning when I wake up feel till bit of Nausea/Vomiting. 4- Take breakfast at about 10.00 AM and after that feeling of Nausea got increased and i also start feeling weakness. These symptoms remains all day. 5- At about 5.15 PM I went to take Shower. After about 2 minutes during shower, i feel shortness of Breath,pressure on chest and Dizziness 6- These Symptoms was for about 4 to 5 second and goes off. 7- After about one minute I feel second time shortness of Breath, pressure on chest and Dizziness. It was bit intensive and for a longer period for about 10 second. 8- At this point I realized that this is something serious happening to me. 9- I came out from the Vertical Shower and called my wife that I am not feeling well. She was at this time at first floor. 10- I think it is about 1 minute after when I came from shower, I feel third time shortness of Breath, pressure on chest and Dizziness. I was very severe and within a second or so I passed out and fell down into the Jacuzzi which is beside the Vertical Shower. 11- Within a minute, my wife and my son came to the scene. At this time my wife finds me unconscious with my eyes open. 12- She shouted my name and then I came into my senses and told them to get me out of Jacuzzi. 12- My wife and my son get me out and carried over to the bedroom. I was feeling no shortness of Breath and Dizziness but mild pressure on chest, shivering and chill. 13- Thanks GOD I did not get any body injury except little bit of hit at my Neck and back of the Head. 14- My wife immediately called to my Primary Care Nurse and then I talk to her explain the whole situation and then asking for advise. 15- She advise me to go to any near Hospital Emergency for any urgent Medical care. 16-A about 6.00 PM I went to Emergency. At this time I was feeling Nausea and Shortness of breath. 17- The Nurse immediately check my blood pressure, temperature, oxygen and pulse. These all was normal. Nurse also provide me IV medicine for Nausea. 18- During my stay at Emergency, I again feeling mild tightness/pressure in chest beside shortness of breath and shivering, therefore Emergency Doctor advise me that will admit to the hospital and do the complete check of any stroke and heart attack. 19- I was in the Hospital for 2 nights. During this stay I was under care of: -Attending Physicism: -Cardiology Physician 20- They have carried out Multiple Blood and Radiology Test as stated below. As per Doctors, all of my Test results are Normal, and they did not find any sign of Stoke and Heart Attack. -Multiple Blood Lab test. -XR CHEST 1 V -CT C-SPINE WO CONT. -CT HEAD-BRAIN WO CONT. -CT ANGIO HEAD W&WO CONT. -CT ANGIO NECK W&WO CONT. -CTA CHEST FOR PE -MRI BRAIN WO CONTRAST . -STRESS TEST. 21- I was discharge from the Hospital on 01/18/21 at 17.34.",Not Reported,,Yes,Yes,,Not Reported,Y,01/15/2021,01/16/2021,1.0,PVT,,,,,,"['Angiogram cerebral normal', 'Angiogram pulmonary normal', 'Arteriogram carotid normal', 'Asthenia', 'Blood test normal', 'Cardiac stress test normal', 'Chest X-ray normal', 'Chest discomfort', 'Chills', 'Computerised tomogram head normal', 'Computerised tomogram spine', 'Dizziness', 'Dyspnoea', 'Fall', 'Head injury', 'Loss of consciousness', 'Magnetic resonance imaging brain normal', 'Malaise', 'Nausea', 'Neck injury', 'Scan with contrast normal', 'Vomiting']",1,MODERNA,IM 971996,PA,33.0,F,I have a positive pregnancy test on 12/26. I went to ER for bleeding on 12/28. On 1/7 went to pregnancy center for intermittent bleeding and 1/12. It might be potential of more bleeding so far haven't had any bleeding pst week. (estimated date of delivery 9/7/2021),Not Reported,,Not Reported,Yes,,Not Reported,,12/18/2020,12/26/2020,8.0,PVT,"Prenatal Vit, Vita D",No,No,,Allergy macrobid,"['Activated partial thromboplastin time', 'Exposure during pregnancy', 'Haemorrhage in pregnancy', 'International normalised ratio', 'Liver function test', 'Metabolic function test', 'Pregnancy test positive', 'Ultrasound pelvis', 'Ultrasound scan']",1,PFIZER\BIONTECH,IM 972019,TX,34.0,F,"On Thursday 1/21/2021, around 10am: I felt my left lip and mouth had a numbing taste and effect, I was slowly throughout the day unable to drink out of a cup without dribbling, my right eye was constantly watering, around 4pm: my right arm started tingling and bothering me, around 9pm: I tasted a Novocain(numbing) like taste in my mouth, I showered and went to bed, while in bed around 10:30pm: I drank out of a water cup and immediately drooled water onto my shirt and my right arm was starting to tingle even more, I thought that was out of the ordinary and got up to look in the mirror, when I looked in the mirror, my first thought was to smile and the right side of my mouth drooped, my right eye was drooping and I was unable to smile or close my eye. At 12:30: I went to the ER for tingling on my face and right arm, I thought I was having a stroke. In between home and traveling to the ER, paralysis started on my right side of face",Not Reported,,Not Reported,Not Reported,,Yes,N,12/30/2020,01/22/2021,23.0,PVT,none,no other illnesses at this time,none known,,Penicillin,"['Blood test normal', 'Computerised tomogram normal', 'Drooling', 'Electromyogram normal', 'Eyelid function disorder', 'Facial paralysis', 'Hypoaesthesia oral', 'Lacrimation increased', 'Paraesthesia', 'Taste disorder', 'Urine analysis normal']",1,PFIZER\BIONTECH,IM 972023,NE,30.0,F,"High anion gap metabolic acidosis. Patient developed poor appetite, nausea, and vomiting. She was unable to tolerate oral intake. She presented to the emergency department after two days of vomiting and was found to have high anion gap metabolic acidosis with pH of 7.0 requiring ICU stay. She had no prior hx of diabetes and was noted to be euglycemic. Patient's acidosis resolved after IVF resuscitation.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/21/2021,01/21/2021,0.0,WRK,"Adderall, Albuterol, clonazepam, gabapentin, Kurvelo, Risperdal, Zoloft, Vyvanse",None,"Celiac disease, anxiety, depression, attention deficit disorder",,Gluten,"['Blood bicarbonate decreased', 'Blood glucose normal', 'Blood pH decreased', 'Decreased appetite', 'Euglycaemic diabetic ketoacidosis', 'Hypophagia', 'Intensive care', 'Metabolic acidosis', 'Nausea', 'PCO2 decreased', 'Vomiting', 'White blood cell count increased']",UNK,PFIZER\BIONTECH,IM 972070,TN,64.0,F,"She experienced headache, dizziness and SOB. Later she developed diarrhea, then swelling in her both feet and right knee. She was admitted to the hospital for tests last Friday night and was discharged with gout. They drew fluid from her knee and left ankle. She is in a wheelchair at home.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/14/2021,01/21/2021,7.0,SEN,,,,,,"['Diarrhoea', 'Dizziness', 'Dyspnoea', 'Gout', 'Headache', 'Joint fluid drainage', 'Joint swelling', 'Laboratory test', 'Peripheral swelling', 'Wheelchair user']",1,MODERNA,IM 972092,CA,88.0,F,"Reportedly, this employee's mother died the night of the vaccine. The details are not known at this time.",Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,PVT,Diabetes Prescription,Diabetes Mellitus,Diabetes Mellitus,,None reported,['Death'],1,PFIZER\BIONTECH,IM 972113,TN,91.0,F,"Resident became lethargic and reports of blood coming from resident's nose and mouth on the morning of 1/13/21. Resident went out to ER for eval, and came back to facility with dx of pneumonia and recommendations for resident to be placed on hospice. Resident deceased on 1/14/21. Unknown if vaccine related, but with timeline of events I was advised to report this per medical director of facility, as well as Pharmacy who administered the vaccine.",Yes,01/14/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,SEN,"Pantoprzole, Miralax, Potassium, buspirone, Aspirin 81mg, Atenolol, Depakote, Glucosamine-chondroitin, mirabegron ER, Zyprexa, Atorvastatin, Ocuviteeye&MVM",Resident was Dx with pneumonia the day after vaccine.,"ENCEPHALOPATHY, UNSPECIFIED, ACUTE KIDNEY FAILURE, UNSPECIFIED,UNSPECIFIED DEMENTIA WITH BEHAVIORAL DISTURBANCE, UNSTEADINESS ON FEET, UNSPECIFIED HEARING LOSS, UNSPECIFIED EAR, DRY EYE SYNDROME OF BILATERAL LACRIMAL GLANDS, CONSTIPATION, UNSPECIFIED, LONG TERM (CURRENT) USE OF ASPIRIN,MOOD DISORDER DUE TO KNOWN PHYSIOLOGICAL CONDITION WITH MIXED , GENERALIZED ANXIETY DISORDER, AGE-RELATED OSTEOPOROSIS WITHOUT CURRENT PATHOLOGICAL FRACTURE,HYPERLIPIDEMIA, UNSPECIFIED, LOCALIZED EDEMA, ESSENTIAL (PRIMARY) HYPERTENSIONGASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS, UNSPECIFIED URINARY INCONTINENCE,",,NKA,"['Death', 'Epistaxis', 'Lethargy', 'Mouth haemorrhage', 'Pneumonia']",1,MODERNA,IM 972117,TX,44.0,M,"Syncope, hospitalization for GI bleed for 4 days. probable diagnosis diverticulosis bleed",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,12/28/2020,12/31/2020,3.0,PVT,"Multivitamin, Vitamin C, losartan, HCTZ, citalopram, rosuvastatin, Co Q10, Vitamin D, omega-3 fish oil",None,"Hypertension, anxiety, hyperlipidemia",Syncope - 17 y/o - cannot recall vaccination,No know allergies,"['Colonoscopy abnormal', 'Diverticulum intestinal haemorrhagic', 'Gastrointestinal haemorrhage', 'Oesophagogastroduodenoscopy normal', 'Syncope']",1,PFIZER\BIONTECH,IM 972148,MI,91.0,F,VACCINATION WAS RECEVIED THE MORNING OF 1/5/2021- IN THE EVENING OF THAT DAY RESIDENT SUSTAINED A FALL AND WAS TRASNPORTED TO FACILITY FOR TREATMENT. IT IS NOT UNUSUAL THAT RESIDENT WAS SELF TRANSFERRING AND HAS A HISTORY OF FALLS.,Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,SEN,ATIVAN 0.5MG EVERY 6 HOURS SYNTHROID 75MCG DAILY METOPROLOL TARTRATE 50MG TWICE DAILY MED PASS 2.0 THREE TIMES DAILY COLACE 200MG DAILY DICYCLOMINE 10MG TWICE DAILY NORCO 5-325MG FOUR TIMES DAILY NEURONTIN 100MG TWICE DAILY NEURONTIN 3,RESIDENT SUSTAINED A FALL ON 1/5/2021.,HYPOTHYROIDISM HYPERTENSION GERD ANXIETY DEPRESSION OSTEOARTHRITIS TRAUMATIC SUBDURAL HEMORRHAGE DEMENTIA HYPERLIPIDEMIA ALZHEIMERS SPINAL STENOSIS ATHEROSCLEROTIC HEART DISEASE PULMONARY FIBROSIS ABDOMINAL HERNIA BLADDER DISORDER,,NKDA,"['Computerised tomogram head', 'Fall', 'X-ray of pelvis and hip']",1,MODERNA,IM 972167,AL,74.0,M,"Wife reported that 3 hours after receiving vaccine, pt had MI.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/22/2021,01/22/2021,0.0,PUB,None listed,none listed,none listed,,None listed,['Myocardial infarction'],1,MODERNA,IM 972227,TX,76.0,M,Temperature of 104.0 degrees,Not Reported,,Not Reported,Yes,,Not Reported,N,01/24/2021,01/25/2021,1.0,SEN,"Protonix, Colace, Iron, Vitamin C, Zinc, Losartan, Terazosin, Allopurinol, Aspirin, Atorvastatin, Isosorbide Mononitrate, Nifedipine",GI Bleeed,"Type 2 Diabetes, Cerebral Infarction, Hypertension",,No known allergies,['Body temperature increased'],2,PFIZER\BIONTECH,IM 972263,MI,77.0,F,"Symptoms started to show after 6 hours from having vaccine administered. Patient had stiffness (unable to sit back down from standing position), blank stare, depressed breathing and fever. Transferred to ER, seizures were witnessed. IV Keppra was initiated. Patient was discharged after 2 days and followed up with primary care provider in clinic. Primary provider documented that cellulitis is noted in right arm and antibiotic has been initiated.",Not Reported,,Not Reported,Yes,2.0,Not Reported,,01/21/2021,01/21/2021,0.0,SEN,,,,,"Seasonal allergies, azithromycin, Bactrim DS, penicillins","['Cellulitis', 'Musculoskeletal stiffness', 'Pyrexia', 'Respiratory depression', 'Seizure', 'Staring']",1,MODERNA,IM 972267,PA,63.0,M,"We were made aware that days after vaccination the patient suffered a ""major brain hemorrhage"" according to patient's wife. He is currently admitted at a different hospital. After vaccine administration on-site, the patient became unconscious for a few minutes. However, this is common for him - he informed us that he almost always ""passes out"" after vaccine administration. He slowly returned to consciousness without any issues. He was seen by an ED physician prior to leaving the facility. Deemed to be in good health, patient also stated that he felt fine and believed he was okay to leave as these episodes occur frequently following vaccination.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/15/2021,01/22/2021,7.0,PVT,,,Unknown,Brief loss of consciousness,,"['Cerebral haemorrhage', 'Loss of consciousness']",1,MODERNA,IM 972281,PR,20.0,F,"Dificulty breathing, rash all over my neck, shoulders and eyes. Fever.",Not Reported,,Yes,Yes,1.0,Not Reported,N,01/20/2021,01/22/2021,2.0,SCH,fludrocortisone 0/1 mg daily,"Orthostatic intolerance, minor arrhythmia",none,,none,"['Dyspnoea', 'Pyrexia', 'Rash']",UNK,PFIZER\BIONTECH,IM 972363,NC,58.0,F,"1/6/21 5:30 pm Client was as her patients house and stood up to leave and was ""walking like I was drunk."" Felt like her leg was asleep. Got to her car and drove to next patients house. Noticed Rt. sided weakness and knee buckling. Drove herself home and went to bed. 1/7/21 Woke up to increased symptoms, Rt hand and Rt. leg weak, slurring speech. hospital by rescue. Admitted X 7 days. CT SCAN with and without contrast showed no bleed. Telemed Visit, MD ordered MRI to rule out Cerebellum Stroke. MRI showed cerebellum stroke. Transferred to A Rehabilitation X 7 days. Has regained most of her normal functions, continues outpatient therapy.",Not Reported,,Yes,Yes,14.0,Yes,,01/06/2021,01/06/2021,0.0,PUB,"Crestor, Lisinopril, Glimepiride, Eliquis, Metformin",None X 1 mo. Covid positive in April 2020... 21 days of Fever headache and backache DVT ...attributed to Covid in August 2020 Eliquis started,Diabetes Fibromyalgia Sarcoidosis High Cholesterol,,Biaxin,"['Cerebellar stroke', 'Computerised tomogram normal', 'Dysarthria', 'Dysstasia', 'Gait disturbance', 'Hemiparesis', 'Hypoaesthesia', 'Magnetic resonance imaging brain abnormal', 'Scan with contrast normal']",1,MODERNA,IM 972370,,60.0,M,patient received covid vaccine and had a heart attack the next day and died,Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,,01/20/2021,01/21/2021,1.0,PHM,,,,,,"['Death', 'Myocardial infarction']",UNK,MODERNA, 972392,IL,78.0,F,"Patient sent to hospital 1/2 and 1/5. Returned both times to nursing home covid unit without a hospital admission. Resident had been diagnosed with COVID later in the day on 12/30, when routine testing PCR results returned to facility, after resident had already had her first covid vaccination on 12/30/20 in the morning. Resident continued decline, was again sent to hospital on 1/24/21, and expired in hospital 1/25/21.",Yes,01/25/2021,Not Reported,Yes,1.0,Not Reported,N,12/30/2020,01/02/2021,3.0,SEN,,Left femur fx 12-7-20 UTI 12-7-20,Diabetes Type 1 Rheumatoid Arthritis GERD HTN,,,"['COVID-19', 'Death', 'General physical health deterioration', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 972394,CA,65.0,M,Died about 24 hours later,Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/20/2021,1.0,PHM,,Unknown,No chronic health conditions,,Unknown,['Death'],1,MODERNA,SYR 972399,OH,37.0,F,"Began medication (follitropin 200 units) for assisted reproductive technology on evening of 01/02/21. Added ganirelix injections on 01/06/21. Trigger injection with leuprolide administered at 20:00 on 01/11/21. Immediately prior to oocyte retrieval on 01/13/21, given 1L IVF and ampicillin (dose unknown) at approx. 07:30am. Retrieval at 08:00am was uneventful, but notable for 17 oocytes retrieved and only 10 were mature. Post-procedure vitals were WNL. Discharged home from facility (Family Health Center) at approx. 09:30am. At approx. 12:00pm, noted increasing abdominal girth. At approx. 14:00, noted mild shortness of breath. Abdominal distention and shortness of breath continued to worsen. Unable to recline even moderately due to difficulty breathing.",Not Reported,,Yes,Yes,2.0,Not Reported,U,12/27/2020,01/13/2021,17.0,PVT,prenatal vitamin,,,,,"['Abdominal distension', 'Assisted reproductive technology', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram pelvis abnormal', 'Dyspnoea', 'Haematocrit decreased', 'Haemoperitoneum', 'Hypotension', 'Infusion site extravasation', 'Oocyte harvest', 'Packed red blood cell transfusion', 'Pelvic haematoma', 'Pelvic haemorrhage', 'Scan with contrast abnormal', 'Therapeutic embolisation', 'Waist circumference increased']",1,PFIZER\BIONTECH,IM 972404,GA,23.0,F,"covid vaccine 1/21, 24hrs latere developed tach, dysphagia , difficulty swallowing, difficulty speaking, weakness left side of face and progressive weakness LUE. and SOB",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/23/2021,2.0,PVT,"Acetaminophen, Cefuroxime, Dalteparin, Diphenhydramine, ergocalciferol, Famotidine, Gabapentin, insulin, Melatonin, methylprednisolone, rituximab, ondansetron, sertraline, trazodone","neuromyelitis optica, UTI, neuropathic pain, neurogenic bowel, neurogenic bladder","NMO, paralysis",,Tree nuts,"['Dysphagia', 'Dyspnoea', 'Facial paresis', 'Muscular weakness', 'Speech disorder', 'Tachycardia']",1,MODERNA,IM 972424,TX,78.0,M,"Pfizer-BioNTech COVID- 19 Vaccine EUA:Patient with significant PMHx of alcoholism, AFIB, CHF, COPD, DM, GERD, MI, HTN, pacemaker placement stroke, and hyperlipidemia who presents to the ED with CC of dizziness. Pt states that two days prior he slipped and fell and hit his head, and was unable to ambulate after the fall. Pt denies any LOC, but states he is currently on Xarelto. Pt currently c/o back pain. Pt went for his first COVID-19 immunization 1/22/2021 when he became suddenly dizzy. Patient denies chest pain, shortness of breath, nausea, vomiting, diarrhea, abdominal pain, fever, chills, or any other acute complaints. Progress Note: ""Dizziness, near-syncope: Onset following injection of COVID-19 vaccination.",Not Reported,,Not Reported,Yes,,Not Reported,,01/22/2021,01/22/2021,0.0,PVT,"Amlodipine 5 mg daily, Atorvastatin 80 mg daily, Baclofen 10 mg nightly prn, Breo Elipta 100/25 mcg 1 puff daily, clonazepam 1 mg nightly, Colesevelam 1875 mg twice daily, Duloxetine 60 mg twice daily, Esomeprazole 40 mg tice daily, gabapen",Acute Hypokalemia (Serum K = 2.8); S/P Fall 2 days prior,"Chronic Kidney Disease (Stage 4), Type II Diabetes, Hypertension, Major Depressive Disorder, Paroxysmal atrial fib.",,No Known Drug Allergies,"['Back pain', 'Dizziness', 'Presyncope']",1,PFIZER\BIONTECH,IM 972436,CA,35.0,F,"15 weeks pregnant female with localized rash on left lower back. Itchy, occasionally painful",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/22/2021,1.0,PVT,,,,,,"['Exposure during pregnancy', 'Rash', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 972447,ND,83.0,F,"She was admitted to the hospital on 1/24/21 with acute symptoms of fatigue, malaise and some increased confusion. Patient also developed a junctional heart rhythm on night of admission.",Not Reported,,Not Reported,Yes,2.0,Not Reported,,01/23/2021,01/24/2021,1.0,PVT,,,,,,"['Confusional state', 'Fatigue', 'Malaise', 'Supraventricular tachycardia']",1,MODERNA,IM 972527,AZ,34.0,F,pt reports tightness in chest and throat she reports palpatations and she felt she couldn't breath.,Not Reported,,Not Reported,Yes,,Not Reported,N,01/22/2021,01/22/2021,0.0,PVT,,,,,allergies cipro,"['Chest discomfort', 'Dyspnoea', 'Electrocardiogram', 'Palpitations', 'Throat tightness']",UNK,MODERNA, 972540,MN,51.0,M,"1/22/2021 this resident was found on his kitchen floor having severe Grand Mal seizures and was profusely foaming from the mouth. RN (writer) responded to the emergency. Resident had 8 seizures between the time of calling 911 and them arriving. They had been IV pushing Ativan and Versed. The seizures did not stop. He was rushed to Hospital, intubated, placed on life support and admitted to the ICU. Resident had an emergency craniotomy and they did not find any infection or cause of the seizures. Many other tests were done and nothing was determined to be the cause at this time. Reported to ICU nurse on 1/23/2021 that resident had received the Moderna vaccine a couple days prior.",Not Reported,,Yes,Yes,4.0,Not Reported,U,01/19/2021,01/22/2021,3.0,SEN,"Tylenol, Clonidine, Melatonin. Nicotine patch , and Senna PRN",No,Hx. of assault causing subdural hematoma/TBI and Craniotomy 10/7/2020. Cranioplasty done 11/11/2020. Cognitive impairment Hx of drug and alcohol abuse,,NKDA. Some intolerance to food with dairy in it.,"['Craniotomy', 'Endotracheal intubation', 'Foaming at mouth', 'Generalised tonic-clonic seizure', 'Intensive care', 'Life support']",UNK,MODERNA,IM 972545,WI,93.0,M,"Reporting per Pfizer that patient tested positive for COVID post-vaccination (1/21/2021) and was hospitalized (1/24/2021). Patient received Bamlanivimab treatment 1/22/2021, 2nd dose will be deferred 90 days per PCP. Patient admitted for hypoxia, improved SPO2 to >95% on room air, and was discharged back to ALF 1/25/2021.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/13/2021,01/21/2021,8.0,UNK,,,"Squamous cell carcinoma, sensorineural hearing loss, nummular eczema, lumbar spinal stenosis, hypertension, gait instability, dyslipidemia, diabetic polyneuropathies, diabetes, coronary artery disease, cataract, benign positional vertigo, seborrheic keratosis, restless leg syndrome.",,"Lisinopril, pravastatin","['Hypoxia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 972580,,43.0,M,"1/22/21 AM BODY TEMPERATURE WAS 102.3(F). RAPID COVID TEST RESULTS: NEGATIVE. 1/25/21 AM BODY TERMPERATURE WAS 104(F), ALSO RECENT SERUM LAB TEST DEMONSTRATED ELEVATED LIVER ENZYMES",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/22/2021,1.0,PVT,,CELLULITIS TREATED WITH ANTIBIOTICS 1/11/21-1/25/21,,,,"['Body temperature increased', 'Hepatic enzyme increased', 'SARS-CoV-2 test negative']",1,MODERNA,IM 972610,CA,65.0,M,"Patient was tested positive for Covid-19 on 12/9/20. Patient received Covid Vaccine on 1/21/21. Patient was observing for 15 minutes in treatment room by Nursing staff. Patient denied any signs/symptoms adverse effect: headache, dizziness & weakness, difficulty breathing, muscle pain, chills, nausea and vomiting, and fever . Patient seated on treatment table appeared to be relaxed, respiration even and unlabored. Health teaching provided. Patient educated to report any changes in condition to staff immediately. Patient verbalized understanding and able to verbalize signs and symptoms and adverse effects to be aware of related vaccine. On 1/22/21: patient was seen by medical provider for ""altered behavior"". Per medical provider's documentation: ""Patient was fallen on 1/2/21 and was sent out to outside hospital on 1/4/21. CT head: no intracranial abnormality, age-related changes. Patient had labs (B12, RPR, folate) were within normal limit"". We did MMSE today: 22/30 score ""mild dementia"" On 1/23/20: ""Patient was inside his cell. He was walking towards cell door to obtain his breakfast, when custody witnessed him collapse and activated the alarm. Nursing staff arrived at cell front at 06:34 am and found the patient pulseless and unresponsive, and CPR was immediately initiated. AED was attached at 06:35 am and no shock advised. AMR then arrived and patient did not have ROSC, and was pronounced dead at 06:54 am.""",Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/23/2021,2.0,OTH,"Aspirin EC 81mg, Atorvastatin 10mg, Glipizide 5mg, Lisinopril 40mg, Metoprolol tartrate 25mg, Latanoprost, Sertraline 25mg, Paliperidone 324mg q28 days, Acetaminophen 325mg, Naproxen 500mg, Capsaicin 0.025%, Glucose 40%, Naloxone Nasal Sp",Fall on 1/2/2021,"Allergic Rhinitis, Back Pain, BPH, Cataract, DM2, Essential hypertension, Hyperlipidemia, Morbid Obesity, Schizophrenia",,No known allergy,"['Abnormal behaviour', 'Death', 'Dementia', 'Pulse absent', 'Resuscitation', 'Syncope', 'Unresponsive to stimuli']",1,MODERNA,IM 972615,NY,83.0,F,"Tired at first, slept 20 min then got up and had no control of my movement to walk, could not remember short term, nausaness, lost heart beat at the hospital, was in the hospital for atleast a couple of weeks and then another couple of weeks in rehab. Now have a pacemaker.",Not Reported,,Not Reported,Yes,,Not Reported,N,10/01/2020,10/01/2020,0.0,PHM,alprazalan,none,anxiety due to an accident years prior,,no,"['Amnesia', 'Cardiac arrest', 'Cardiac pacemaker insertion', 'Fatigue', 'Gait disturbance', 'Heart rate abnormal', 'Laboratory test', 'Loss of control of legs', 'Nausea', 'X-ray']",UNK,"SEQIRUS, INC.",IM 972631,CA,92.0,M,"Felt like his throat was closing. He was given 25mg benadryl and then developed dizziness, heart racing, chest pain, shortness of breath, jaw pain. Was in SVT on arrival to ED",Not Reported,,Yes,Yes,,Not Reported,Y,01/25/2021,01/25/2021,0.0,MIL,"Kcl, Furosemide, Enalapril, Lactobacillus, Bisocodyl, Spironolactone, Cyanocobalamin, Vit D3, Darolutamide, omeprazole, alendronate, multivitamin",Denies,"CAD, prostate cancer, HTN< GERD, hypoparathyroidism, thoracic aortic aneursym",,Codeine (nausea/vomiting),"['Chest pain', 'Dizziness', 'Dyspnoea', 'Pain in jaw', 'Palpitations', 'Supraventricular tachycardia', 'Throat tightness']",1,PFIZER\BIONTECH,IM 972635,NV,91.0,M,"Patient admitted to Inpatient on 1/13/2021 after receiving vaccine on 1/6/2021. Diarrhea and dizziness. Since Sunday, corona vaccination last week. No headache, abdominal pain, nausea or vomiting, loss of taste or smell, muscle aches or general malaise. Patient was hypoxic at clinic visit, 84% on room air, transferred to ED for evaluation.",Not Reported,,Not Reported,Yes,13.0,Not Reported,N,01/06/2021,01/13/2021,7.0,PVT,"Magnesium, Potassium, Tamsulosin","diarrhea, dizziness, low oxygen saturation at 84%",benign prostatic hyperplasia chronic kidney disease gastroesophageal reflux disease hypertensive disorder,,No known allergies,"['Amylase increased', 'Bilirubin urine present', 'Blood creatinine increased', 'Blood glucose normal', 'Blood lactic acid decreased', 'Blood magnesium normal', 'Blood potassium increased', 'Blood sodium decreased', 'Blood urea increased', 'Blood urine present', 'Chest X-ray abnormal', 'Diarrhoea', 'Dizziness', 'Drug screen negative', 'Haematocrit normal', 'Haemoglobin normal', 'Hypoxia', 'Influenza virus test negative', 'International normalised ratio normal', 'Interstitial lung disease', 'Lipase increased', 'Platelet count normal', 'Pneumonia', 'Protein urine present', 'Prothrombin time normal', 'Red blood cell count normal', 'SARS-CoV-2 test positive', 'Troponin normal', 'White blood cell count decreased']",1,MODERNA,IM 972658,FL,34.0,F,Rash occurred day after on stomach then each day rash would form somewhere else. Itchiness gradually worsened each day and rash gradually spreading. Large swollen welt on lower back and past 4 hours progressively increasing in itching and widespread rash over entire back and shoulders. Red swollen welts all throughout with excessive itching. Took levocetirizine and will take 50 mg Benadryl in a few hours. Examined by dermatologist over video and he suggested IM kenalog and antihistamines.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/16/2021,1.0,PVT,"Adderall, multivitamin",None,"ADHD, GERD, IBS, asthma (controlled without meds)",,"Pet allergies (rats, horses, Guinea pigs, rats, cats, dogs) Environmental allergies (ragweed, pollen, grass, dust, mold)","['Erythema', 'Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 972677,OK,42.0,F,"Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, heart racing. Within 5 minutes of vaccine. Epinephrine auto injection and oxygen followed by steroid, Benadryl and omeprazole with oxygen in the ER.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,Claritin 10mg PO,None,None,,"Peanuts, pecans, walnuts, pine nuts, sunflower seeds","['Dizziness', 'Dyspnoea', 'Electrocardiogram normal', 'Feeling hot', 'Hyperhidrosis', 'Palpitations', 'Throat tightness']",1,PFIZER\BIONTECH,IM 972706,HI,88.0,F,I do not know which Covid-19 vaccine my mother had received the day before but she reported pain in her shoulder and arm to her caregiver on Sun morning Jan 24th. She did not report any problems with breathing. The caregiver gave her a massage before letting her take an afternoon nap. She was later discovered to be unresponsive and not breathing around 5pm. EMS declared her dead at 5:59pm and were already gone by the time I arrived at the caregiver's house around 6:05pm. She was still slightly warm. Her mouth was slightly opened and her left hand was in a fist. My father had been in the room the whole time and thought she was still sleeping.,Yes,01/24/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/24/2021,2.0,PVT,Not know at this time,,,,,"['Arthralgia', 'Death', 'Pain in extremity', 'Respiratory arrest', 'Unresponsive to stimuli']",1,UNKNOWN MANUFACTURER,SYR 972711,OK,65.0,F,"Slightly sore arm days 2&3 after vaccination, no visible reaction Red, hot, sore & itchy swath 3"" X 6"" one week after vaccination lasting 4 days so far.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/22/2021,7.0,OTH,OTC / Supplements Natural Calm 1 heaping tsp every evening Colon Motility Blend 3 caps twice per day Lactobacillus 1 cap twice per day Ageless Hydro-C: Heaping tsp in AM. Heaping tsp in AM DHEA 10mg: 1 capsule every morning. - 10mg capsul,none,seasonal hay fever,,latex,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Limb discomfort']",1,MODERNA, 972719,OH,38.0,F,"Received second COVID vaccine Moderna on Wednesday evening at 6pm. Later that night, I was a little light-headed and achey, but went to bed. On thursday, my legs and arms were extremely achy. I took Tylenol and Motrin in the morning. It seemed to help some, but continued to feel very achy in my legs. I left work early (I am a pediatrician) on Thursday and went home and just sat and rested. I felt terrible, but had talked to other colleagues who felt very bad that first day after the shot. Friday morning, I woke up still achy but feeling better overall. I took motrin and Tylenol again on Friday morning. I worked the whole day seeing patients. Was tired, but got thru the workday. At around 6pm, I noticed petechiae rash on my lower legs. The rash started spreading thru the night- up my legs and to my arms. I went to ER. They did order CBC, CMP. Platelets were undetectable- 1 platelet was seen under microscope. CMP was normal. I was told to go to bigger hospital. I went, My platelets read as 4. I was admitted for two nights. Two doses of IVIG were given and I was put on Decadron 40mg PO daily for 4 days. I had tylenol, benadryl, zofran before the IVIG and after. I will see Hematology next week for follow up. Platelets yesterday at discharge were 60. Will be checked frequently for the next few months. ITP= diagnosis. COVID shot was trigger.",Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/20/2021,01/22/2021,2.0,PVT,"1) Zoloft 25mg PO daily 2) Sprinolactone 150mg PO daily 3) Vitamin D 10,000 units daily PO 4) vitamin B12 5,000 daily PO 5) Tylenol 650mg every 4 hrs prn 6) Advil 800mg every 8-12 hours prn","Received first COVID vaccine on December 23, 2020 Second COVID vaccine Jan 20, 2020 MODERNA brand",Platelets did drop to 55-115 last year (December 2019). Vitamin B12 was started which brought them from 55 to 112 or so. Positive anti-platelet antibodies were detected. Never required more than vitamin B12.,,Penicillin and Zithromax (confirmed by allergy testing),"['Dizziness', 'Full blood count normal', 'Immune thrombocytopenia', 'Malaise', 'Metabolic function test normal', 'Pain', 'Pain in extremity', 'Petechiae', 'Platelet count decreased', 'Rash']",2,MODERNA,IM 972721,KY,25.0,F,"Hives and minor lip swelling 1/24/21 throughout the day. Took two Atarax after waking up. Took multiple Benadryl throughout the day. Did not help. Took 50mg Benadryl at bedtime along with Claritin. Woke up 1/25/21 with swelling of both lips and swelling in throat what felt like around tonsil and lymph area (have had tonsillectomy). Went to ER was given additional Benadryl PO, IV Decadron and IV Pepcid. Was discharged home with a prednisone taper prescription, Benadryl and Pepcid. My full biological sister also had minor hives after her second dose of Pfizer , but has never had an anaphylactic reaction in the past and her onset was within the first day after vaccination.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/20/2021,01/24/2021,4.0,PVT,"Verapamil, aimovig, magnesium, prenatal, linzess, Claritin, Effexor, trazodone, cyclobenzaprine. Finished Flagyl 1/23/21 in AM",Bacterial vaginosis,Asthma PTSD Migraines Insomnia IBS with constipation,,PCN - anaphylaxis,"['Lip swelling', 'Pharyngeal swelling', 'Urticaria']",2,PFIZER\BIONTECH,IM 972782,CA,81.0,F,"Resident expired on 1/23/21 . Resident receiving care under hospice ,diagnosis Acute Myeloid Leukemia.",Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/23/2021,5.0,SEN,"Amlodipine 2.5 mg Eliquis 2.5mg Aspirin 81 mg Cholecalciferol 1.25 mg Ondansetron 4mg , Thiamine HCL 100, Inrebic 100mg Oral Capsule",Acute Myeloid Leukemia,"Myelofibrosis Hypertension Generalized Weakness Ulcerative Colitis Lymphadenopathy Diabetes Mellitus Type 2 Mets to Bone, Lymph node metases, DVT",,"Compazine Trazadone, Augmentin Penicillin","['Acute myeloid leukaemia', 'Death']",1,PFIZER\BIONTECH,IM 972784,FL,73.0,F,"STROKE SYMPTOMS 5 DAYS LATER. SEVERE HEADACHE, DIZZINESS , SLURRED SPEACH, TROUBLE REMEMBERING SOME WORDS, DIFFICULTY SIGNING NAME, HIGH bp WAS ADMINISTERED EMERGENCY CLOT BUSTING DRUG IV AND THEN TRANSFERRED TO NEUROLOGY HOSPITAL. SYMPTOMS OF SLURRED SPEECH, DISAPPEARED NEXT DAY, WRITING HAND RETURNED TO NORMAL RAPIDLY AFTER IV. SLIGHT HEADACHE REMAINED FOR A COUPLE OF DAYS",Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/11/2021,01/16/2021,5.0,PVT,NONE,NONE,NONE,,NONE,"['Aphasia', 'Blood test', 'Chest X-ray', 'Dizziness', 'Dysarthria', 'Hand-eye coordination impaired', 'Headache', 'Hypertension', 'Magnetic resonance imaging', 'Neurological symptom']",1,PFIZER\BIONTECH,IM 972836,MA,88.0,F,sudden death,Yes,01/24/2021,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/24/2021,4.0,SEN,"lorazepam, trazodone, levothyroxine , acetaminophen, multivitamin, senna",no,Alzheimer's disease,,"Levofloxacin, ACE inhibitors",['Sudden death'],2,PFIZER\BIONTECH,UN 972884,MO,70.0,M,Hospitalization severe pneumonia liver damage,Not Reported,,Yes,Yes,,Not Reported,N,01/20/2021,01/21/2021,1.0,PVT,"Metoprol, Torsemide, Spirolactone, potassium,Midodrine, vit C, vit D3,",Excited,Heart disease,,Ativan,"['Liver injury', 'Pneumonia']",UNK,PFIZER\BIONTECH, 972890,NY,96.0,F,"On the evening of 10JAN2021, patient experienced a low grade fever, decreased oxygen saturation of 38%, heart rate of 124, confusion. Patient received oxygen via face mask, morphine and ativan. By 11JAN2021, patient was no longer verbal, able to eat or communicate and was kept on comfort measure only. On the morning of 17JAN2021, the patient passed away.",Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/10/2021,12.0,SEN,unknown,"COVID-19 positive on November 19, 2020 and didn't test negative until December 26, 2020",Macular Degeneration,,None,"['Aphasia', 'Communication disorder', 'Confusional state', 'Death', 'Feeding disorder', 'Oxygen saturation decreased', 'Pyrexia']",1,MODERNA,UN 972898,OH,68.0,M,"5 days after receiving the vaccination the patient developed generalized malaise progressing to encephalopathy. He was admitted to the hospital with presumed septic shock, and work-up revealed hemophagocytic lymphohistiocytosis. He died from the disease process 9 days after vaccination.",Yes,10/09/2019,Not Reported,Yes,3.0,Not Reported,N,09/30/2019,10/05/2019,5.0,PVT,"pred forte right eye, zaditor right eye, finasteride 5 mg daily, aspirin 81 mg daily, MVI, xyzal 5 mg daily, saw palmetto, antivert 25 mg TID PRN, pantoprazole 40 mg daily, lisinopril 20 mg daily, verapamil 180 mg daily, atorvastatin 20 mg",,"HTN, high cholesterol, BPH, meniere's",,NKDA,"['Death', 'Encephalopathy', 'Haemophagocytic lymphohistiocytosis', 'Laboratory test', 'Malaise', 'Septic shock']",1,SANOFI PASTEUR,IM 972917,WA,41.0,F,"This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immunization, she appropriately stayed in the waiting area for the 30 minutes. She then got in car and 15 minutes after, she noticed that her tongue was feeling full/swollen and that was experiencing neck swelling. These symptoms persisted and resembled a prior allergic response to Tetracycline and Aleve. Wheezing and breathing difficulty ensued and EMS was activated. On arrival to the emergency department she was found to have wheezing with stridor. A dose of epinephrine was administered and she was monitored in the emergency department with an initial improvement in symptoms. Approximately one hour and 30 minutes after initial epinephrine administration patient reported that she was having continued difficulty swallowing and she was starting to feel a little worse. At this point a second dose of IM epinephrine was administered. The patient was subsequently admitted to inpatient medicine team for further monitoring.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/25/2021,01/25/2021,0.0,MIL,"HCTZ (25mg daily) every morning Metformin (500mg twice daily) Celexa (40mg PO every day at bedtime) Wellbutrin (150mg ER PO daily) Topomax (50mg PO BID) Potassium supplement(BID, OTC) Magnesium gluconate supplement OTC MV",None,,,"PCN, Aleve, Cipro, Tetracycline, Iodine","['Dysphagia', 'Dyspnoea', 'Feeling abnormal', 'Stridor', 'Swelling', 'Swollen tongue', 'Wheezing']",2,PFIZER\BIONTECH,IM 972961,,72.0,F,Pt developed Afib at 2AM on 1/23. Started on amiodarone and Xarelto,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/22/2021,01/23/2021,1.0,UNK,"Rifampin, azithromycin, ethambutol, s/p RCHOP 8/2020",MAC,Large B cell lymphoma in remission,,Pollen extracts,['Atrial fibrillation'],1,PFIZER\BIONTECH,IM 972964,MN,65.0,F,"the patient appeared with a swollen face when the morning shift arrived at 7 am . no signs of respiratory concerns, vitals within normal limits . face swollen and warm to the touch. the patient was taken to urgent care by her POA. clinic transferred the patient to a local hospital where she admitted to be observed overnight. The Resident returned back to the facility the next day (1/21/21). Reported received verbal notification from POA that the patient's primary physician is recommending to not receive the second dose of the Moderna vaccine.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/20/2021,01/21/2021,1.0,SEN,"Atorvastatin 20mg, melatonin 6mg, memantine 10mg, Polyeth glyc 17g, quetiapine 25mg, venlafaxine 75mg, Haloperidol 1mg PRN, Acetaminophen 500 PRN.",none,"dementia,",,"Ace inhibitors, Bee venom","['Skin warm', 'Swelling face']",1,MODERNA,IM 972972,NJ,43.0,F,"Worsened tinnitus. I had tinnitus that had largely resolved and since the vaccine, it's been extremely loud - more loud than ever before. I don't have any other lifestyle issues that would've aggravated the tinnitus.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/09/2021,01/09/2021,0.0,UNK,Multivitamin,none,none,,none,"['Condition aggravated', 'Tinnitus']",2,PFIZER\BIONTECH,IM 972985,OK,78.0,M,AROUND 9:30 PM I BECAME VERY WEAK AND FEVERISH. I HAD CHILLS AND I COULD NOT EAT OR DRINK. I COULD NOT GET OUT OF BED TO GO TO THE BATHROOM. I THREW UP TWO DIFFERENT TIMES. THE NEXT DAY I WAS STILL VERY WEAK. I TRIED TO GET OUT OF MY CHAIR AND I FEEL. I WAS UNABLE TO GET UP WITHOUT ASSISTANCE. THE WEAKNESS AND FEVER CONTINUED FOR THE NEXT THREE DAYS. I AM STILL VERY WEAK AND CAN'T HARDLY WALK. MY HIP FLARED UP AND CAUSED ME GREAT PAIN AND IMBALANCE. ALL THE AREAS THAT I HAD OCCASSIONAL OSTEOARTHRITIS I AM NOW IN CONSTANT PAIN. I CAN NO LONGER SLEEP ON MY RIGHT SHOULDER. BOTH OF FEET FLARED UP AND HURT ALL THE TIME.,Not Reported,,Not Reported,Not Reported,,Yes,N,01/21/2021,01/21/2021,0.0,PUB,"acetaminophen, amlodipine, atorvastatin, b complex, clopidogrel, furosemide, hydrchlorothiazide, levothyroxine, losartan, meformin, multi vitamin, potassium chloride crys, primidone, tamsulosin, tramadol,","acute rt arterial ischemic stroke mca; beningn essential tremor, benign non nodular prostatic hyperplasia with loer urinary tract symptoms, benign prostratic hyperplasia, cerebral infaarcation due to embolism of vertebral artery, cvd, diabetes mellius, edema, epidiymitis right, hpercalcemia, hyperhomocystinemia, hypertension, hyporthyroidism, mixed hyperlipidemia, pfo, osteroarthritis multiple joints, scoliosis, inus bradycardia","acute rt arterial ischemic stroke, mca; beningn essential tremor, benign non nodular prostatic hyperplasia with loer urinary tract symptoms, benign prostratic hyperplasia, cerebral infaarcation due to embolism of vertebral artery, cvd, diabetes mellius, edema, epidiymitis right, hpercalcemia, hyperhomocystinemia, hypertension, hyporthyroidism, mixed hyperlipidemia, pfo, osteroarthritis multiple joints, scoliosis, inus bradycardia",,iodine and sulfa antibiotics,"['Arthralgia', 'Asthenia', 'Balance disorder', 'Chills', 'Condition aggravated', 'Fall', 'Feeding disorder', 'Gait disturbance', 'Mobility decreased', 'Osteoarthritis', 'Pain in extremity', 'Pyrexia', 'Sleep disorder', 'Vomiting']",1,MODERNA,SYR 973014,AZ,60.0,F,"Awoke in the early morning hours of 1/23/21 with severe vertigo, almost fell over twice while walking to the bathroom. Vertigo caused severe nausea and vomiting, with inability to drink or eat for 36 hours. I became dehydrated. Went to the ED and was admitted overnight for vertigo, orthostatic hypotension, dehydration.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/20/2021,01/23/2021,3.0,OTH,Levothyroxine Pantoprazole,None,Hypothyroidism Migraines,"chllls, myalgia, fatigue, extensive erythema of length of arm -60 years- 10/10/20 - Shingles, Shingrix",None,"['Balance disorder', 'Blood electrolytes normal', 'Chest X-ray normal', 'Dehydration', 'Echocardiogram normal', 'Electrocardiogram normal', 'Feeding disorder', 'Nausea', 'Orthostatic hypotension', 'SARS-CoV-2 test negative', 'Troponin', 'Vertigo', 'Vomiting']",2,PFIZER\BIONTECH,IM 973044,NJ,62.0,F,"Morning of 1/24/21 (Sunday), patient saw that the right side of her face was drooping, her right eye was swollen and excessively tearing. Patient noted drooling out of the right side of mouth when drinking fluids or eating food. Patient was unable to chew on the right side, had difficulty speaking due to the drooping of the right side of her mouth. Symptoms persisted into the next day. Patient was seen by her PCP and was diagnosed with Facial Palsy (Bell's Palsy). Patient's neurological assessment was negative for stroke symptoms.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/14/2021,01/24/2021,10.0,PVT,Metformin 1000 mg BID Glimepiride 2 mg once a day Januvia 100 mg once a day Losartan 25 mg once a day Atorvastatin 20 mg once a day Levocetirizine 5 mg once a day Vitamin D Multivitamins Calcium Vitamin C Glucosamine Vitamin B12 Tumeric,,Type II Diabetes Hypertension High cholesterol Ocular allergies Rosacea Squamous cell carcinoma (2013),,Crestor,"['Drooling', 'Eye swelling', 'Facial paralysis', 'Lacrimation increased', 'Mastication disorder', 'Neurological examination normal', 'Speech disorder']",1,MODERNA,IM 973794,ND,33.0,F,"Moderna Covid-19 Vaccine EuA Horrible body aches, headache, feels like bones were breaking, "" was kicking my behind and feeling like poo"".",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,01/19/2021,0.0,PVT,"prenatal vit.,",None,"Migraine, anxiety",,Ceclor,"['Feeling abnormal', 'Headache', 'Pain']",2,MODERNA,IM 973796,,37.0,M,"Thrombocytopenia Narrative: thrombocytopenia requiring hospitalization, meds and platelet infusion",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/25/2021,01/21/2021,,OTH,,,,,,"['Platelet transfusion', 'Thrombocytopenia']",1,MODERNA,IM 973803,,78.0,M,"hypoxemia, urinary retention Narrative: Transferred from facility to ED with 1 day of fevers, hypotension, and c/f new oxygen requirement and admitted to acute care ward on 1/14/21. Tachycardia resolved w/ fluids. Patient was ruled out for PE and infectious workup negative. Fevers, hypoxia resolved overnight. Medicine Team felt symptoms were side effects from COVID vaccine (2nd dose received 1/13). He was treated for possible cellulitis at L shin wound (warm and tender to touch with mild erythema, without fluctuation) with 14-day cephalexin course, however cellulitis not deemed severe and unlikely contributing. Regarding urinary retention, the Discharge Summary stated, ""Urinary retention seemed new in the last day. Pt on condom cath during admission, urinating well."" Discharged 1/15/21 and returned to facility.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/13/2021,01/14/2021,1.0,OTH,,,,,,"['Bladder catheterisation', 'Blood culture negative', 'Culture urine negative', 'Erythema', 'Hypotension', 'Hypoxia', 'Limb injury', 'Pyrexia', 'SARS-CoV-2 test negative', 'Skin warm', 'Tachycardia', 'Tenderness', 'Urinary retention']",2,PFIZER\BIONTECH,IM 973808,,74.0,M,"shortness of breath, chest xray with pulmonary edema, periorbital edema Narrative: 73 yo M w/ PMH HTN, HLD, EVAR (2013) for AAA c/b persistent type II endoleak s/p multilple repairs (2015 & 2017) c/b glue embolization down into the R CIA secured with additional stent placement with the R iliac limb, s/p b/l Iliac artery aneurysm stent 08/31/20, and PTSD. Former smoker, quit 12+ yrs ago. 11/1/20-11/6/20: Hospitalized for acute on chronic back pain, found to multiple hypermetabolic lesions in the axial skeleton. Diagnosed with epithelioid angiosarcoma. Patient discharged to facility. 12/17/20: Patient received his 1st COVID-19 vaccine w/o complications at facility. 12/21/20: Underwent cyberknife treatment. 12/31/20: Transferred from facility to ER for new O2 requirement, SOB, cough, chest X ray / pulm edema, tachycardic and new periorbital edema. 12/31/20: Admitted to ICU before transfer to acute care. 1/1/21: Pulmonary consult, ""Labs are notable for progressive left shift with bandemia, markedly elevated inflammatory markers (D-dimer, ESR, CRP, ferritin, LDH), mild elevation in procalcitonin, mild elevation in lactate that has improved, and negative viral panel including COVID-19 x2. CT chest is notable for b/l GGOs along with some interstitial infiltrates with an upper and particularly mid zone and perihilar predominance, septal thickening and crazy paving, and numerous cystic lesions or pneumatoceles. There is a lack of lobar consolidation and pulmonary nodules. Of note, PET/CT about 2 months ago only demonstrated some mild to moderate emphysema mostly in the upper lobes. Therefore, there has been a relatively dramatic change in a few months, suggesting a more subacute process, rather than an acute infectious process such as a viral pneumonia, including COVID-19 infection, in which the GGOs tend to be subpleural and peripheral. Overall, our suspicion for COVID-19 is relatively low, with negative testing x2 yesterday, negative testing a few weeks ago, and lack of sick contacts, but it is possible. Therefore, higher on the differential is a more subacute infection or chemotherapy-induced pneumonitis. Risk factors include malignancy, chemotherapy, and use of steroids (equivalence of about 27 mg of Prednisone in the form of Dexamethasone since 11/6/20 without PJP prophylaxis). These risk factors, along with consistent imaging and elevated LDH, make PJP quite likely. Fungal infection is less likely based on imaging. Chemotherapy-induced pneumonitis is a possibility, especially given the more subacute picture based on imaging. Both Gemcitabine and Docetaxel can cause pneumonitis. However, the patient has been on steroids, which is used to treat drug-induced pneumonitis, although this does not exclude it completely."" 1/2/21: Transferred to ICU for worsening hypoxemia as patient reached 40L/100% FIO2 and remained on COVID isolation/COVID patient under investigation per ID recommendation. 1/4/21: Isolation precautions discontinued due to lower suspicion for active COVID infection to explain current presentation 1/6/21: Went into atrial fibrillation w/o RVR overnight 1/6. Tolerating, with MAPs in low 60s and HR in high 90s/low 100s. Suspect due to being-1L yesterday from diuresis, lasix stopped. S/p amiodarone bolus + drip, albumin 5% bolus 1/5/21: Macrocytic anemia NOS w/ slowly worsening H/H s/p PRBC x 1 unit 1/7/21: Per ICU Life-sustaining treatment note, ""Following discussion w/ patient that his lung dx has been refractory to txt and hasn't improved despite maximal therapy, patient agreed to transition to hospice after he settles affairs. "" 1/7/21 Infectious Disease note: ""This is an immunocompromised host due to cancer on active chemotherapy (albeit ANC>4000 on admission) and notably had been on daily PO dexamethasone 1 mg TID (total daily dose 3 mg, equivalent to 20 mg PO prednisone) since 11/6/20 without any PJP ppx. There was elevated c/f COVID-19 infection in setting of patient's presenting symptoms, especially in conjunction with b/l GGOs on imaging. Has undergone multiple COVID test that have all resulted negative. Discussed radiographic findings with radiology colleagues, and overall, it is difficult to definitively narrow the differential with imaging alone, but overall density of GGOs seem to appear less likely PJP and more in line with chemical pneumonitis vs COVID, although less typical for viral pneumonia as well. Given false-negative COVID tests are not unheard of, especially in the immunocompromised population, patient was kept on isolation precautions as a PUI for abundance of caution. He is now off precautions. In setting of patient having been on prednisone for some time without PJP ppx, he was also started on treatment dose TMP/SMX. Beta-d-glucan has returned positive, and although not the ideal test for PJP, this can certainly support a potential dx of PJP. Unfortunately, DFA from sputum was not performed due to insufficient sample and currently the patient is unable to produce an additional sample for testing. He is tolerating the high-dose TMP/SMX; we adjusted the dose to three SS tablets TID based on his somewhat declining UOP. Other fungal etiologies are pending work-up as well. Lastly, patient's chemotherapy is known to cause pneumonitis, but per pulmonology team, he receives prophylactic dexamethasone with his chemo cycles that should help to prevent drug-induced pneumonitis. Remains on the differential for now and this should also be concurrently treated with the steroids he is receiving."" 1/10/21: Comfort care initiated. All non-comfort measures were discontinued. Time of death: Jan 10,2021@14:56; immediate cause of death per death note is ""hypoxic respiratory failure""",Yes,01/10/2021,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/31/2020,14.0,OTH,,,,,,"['Anaemia macrocytic', 'Atrial fibrillation', 'Bandaemia', 'Blood beta-D-glucan positive', 'Blood lactate dehydrogenase increased', 'Blood lactic acid increased', 'C-reactive protein increased', 'Chemotherapy', 'Chest X-ray abnormal', 'Computerised tomogram thorax abnormal', 'Cough', 'Death', 'Dyspnoea', 'Fibrin D dimer increased', 'Fungal test negative', 'Haematocrit decreased', 'Haemoglobin decreased', 'Hypoxia', 'Inflammatory marker increased', 'Intensive care', 'Lung infiltration', 'Lung opacity', 'Packed red blood cell transfusion', 'Periorbital oedema', 'Pneumonitis chemical', 'Procalcitonin increased', 'Pulmonary oedema', 'Pulmonary pneumatocele', 'Radiotherapy', 'Red blood cell sedimentation rate increased', 'Respiratory failure', 'SARS-CoV-2 test negative', 'Serum ferritin increased', 'Shift to the left', 'Tachycardia']",1,PFIZER\BIONTECH,IM 973816,,86.0,M,"right hand swelling, right knee swelling, right ankle swelling, facial swelling of left cheek Narrative: Following 1st COVID-19 vaccine dose on 12/17/20, patient seen at Emergency Department on 12/21/20- 12/22/20 for eval of new left cheek swelling and right hand/ankle swelling. Hand x-ray did not show signs of fracture, head CT did not show any signs of new strokes, and labs showed mild BNP elevation. Per ED note, ""Based on the patient history, physical, and initial vital signs - the patient's initial presentation is concerning for heart failure/volume overload->pulmonary edema and bilateral pedal edema."" He received ipratropium neb x1 and returned to facility. Neurology consulted (12/22/20), ""It is difficult to determine whether the patient has a new facial palsy or whether this is recrudescence of his previous stroke deficits. Given the swelling of his left face it is quite possible that there is inflammation causing some partial left facial nerve dysfunction that would not include the forehead. The pattern of weakness is, however, also consistent with what would be expected from his documented right MCA stroke. At this point it is appropriate to consider this a possible complication of his vaccination (Bell's palsy has been reported in some after Covid19 vaccination). However, I would not recommend any specific treatment for the facial weakness as the etiology is still somewhat unclear."" Patient admitted to hospital 1/2/21-1/8/21 for mild hypothermia with possible AMS and found to have adenovirus. Head CT negative for CVA. Sepsis/toxic/metabolic w/u was unrevealing. Given IVF for diarrhea; C diff negative. Discharged to facility. Patient received 2nd COVID-19 pfizer vaccine on 1/13/21 in Right Deltoid w/o complications (lot#: EK9231, exp. 04/30/2021)",Not Reported,,Not Reported,Yes,,Not Reported,N,12/17/2020,12/20/2020,3.0,OTH,,,,,,"['Adenovirus infection', 'Brain natriuretic peptide increased', 'Clostridium test negative', 'Computerised tomogram head normal', 'Diarrhoea', 'Facial paresis', 'Hypothermia', 'Joint swelling', 'Metabolic function test normal', 'Peripheral swelling', 'SARS-CoV-2 test negative', 'Septic screen', 'Swelling face', 'Toxicologic test normal', 'X-ray limb normal']",2,PFIZER\BIONTECH,IM 974753,IL,68.0,F,Experienced shortness of breath upon minimal exertion 24 hours after having receieved the vaccine. Called MD 72 hours vaccine received - MD advised hospital ER. Admitted with pulmonary embolism and deep vein thrombosis. Remains short of breath and is on 4L of oxygen. Receiving anti-coagulants.,Not Reported,,Not Reported,Yes,,Not Reported,N,01/16/2021,01/17/2021,1.0,SEN,"Methotrexate DIOVAN HCT Protonix Folic Acid Multivitamin Vit D, Vit C XANAX",none,LUPUS HTN,,Adhesive Tape NKDA,"['Deep vein thrombosis', 'Dyspnoea', 'Pulmonary embolism']",1,MODERNA,IM 973137,PA,67.0,F,"but tested covid positive; but tested covid positive; had sinus; a little diarrhea; cough; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 13Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer, reporting for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration at the right arm at on 30Dec2020 11:15 at a single dose as the patient works for a medical retirement facility. Vaccination was done in a hospital. Medical history included was reported as none. The patient's concomitant medications were not reported. It was reported that the patient got her first shot on 30Dec2020, but tested COVID positive on 13Jan2021, had sinus, a little diarrhea, and cough. She was on quarantine with her husband as of today. She did not receive any other vaccines that day or 4 weeks prior. No history of any other vaccines or events. She was asking if she can take the second dose of the COVID vaccine. The patient underwent lab tests and procedures which included COVID virus: positive on 13Jan2021. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/13/2021,14.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Cough', 'Diarrhoea', 'SARS-CoV-2 test positive', 'Sinus disorder']",1,PFIZER\BIONTECH, 973150,CA,61.0,M,Pt had slurred speech and left-sided weakness day after vaccine he presented to ER and appears to have CVA,Not Reported,,Not Reported,Yes,,Yes,N,01/20/2021,01/21/2021,1.0,PVT,lipitor asa glipizide coreg losartan,,CAD DM,,nkda,"['Cerebrovascular accident', 'Dysarthria', 'Hemiparesis']",UNK,MODERNA,IM 973155,MI,,M,"tested positive both with a rapid and standard test; tested positive both with a rapid and standard test; This is a spontaneous report from contactable consumer. A 92-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient who was in a nursing home received the vaccine first dose on 04Jan2021. On 10Jan2021, he tested positive both with a rapid and standard test. His fever at the highest was 100.3 and he had chills and a cough but that's all gone now. Thought maybe it's because he received the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/10/2021,6.0,UNK,,,,,,"['Chills', 'Cough', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 973156,,,F,"received the 1st dose on 01Dec2020 and tested positive for COVID on 15Dec2020 but was asymptomatic.; received the 1st dose on 01Dec2020 and tested positive for COVID on 15Dec2020 but was asymptomatic.; This is a spontaneous report from a contactable other healthcare professional reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter was asking what the recommendations are for the administration of the 2nd dose for a patient who received the 1st dose on 01Dec2020 and tested positive for COVID on 15Dec2020 but was asymptomatic. She missed the dosing window of the 2nd dose scheduled on 30Dec2020 due to quarantine. Caller mentioned that patient is recovered and is back to work. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Dec2020. Information about lot/batch number has been requested; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,12/15/2020,14.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 973160,OH,,F,"""symptoms""/tested positive for covid; ""symptoms""/tested positive for covid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 76 with no unit) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if she should get her second dose of vaccine on 25Jan2021, after receiving the first dose on 04Jan2021 and having symptoms and testing positive for COVID on 08Jan2021. The patient continued to have symptoms (unspecified) at the time of report. The patient was taking Tylenol for the symptoms. Outcome of the events was not recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/08/2021,4.0,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 973175,,23.0,F,"tested positive for COVID-19 and her only symptom is sore throat; tested positive for COVID-19 and her only symptom is sore throat; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date were not reported), via an unspecified route of administration on 23Dec2020 at a single dose for covid-19 immunization. The patient's medical history included in contact with somebody who was COVID-positive prior to getting the vaccine. Concomitant medications were not reported. It was reported that the patient was vaccinated last 23Dec2020 and tested positive for COVID-19 and her only symptom is sore throat that lasted for 3 days on unspecified date. She said she is all cleared now and had finished the 14-day quarantine. Is it safe to take the second dose of the COVID-19 vaccine as scheduled? Outcome of the events tested positive for COVID-19 and her only symptom is sore throat was recovered on unspecified date. Information about Lot/batch no has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,,,UNK,,,Medical History/Concurrent Conditions: Exposure to SARS-CoV-2 (prior to getting the vaccine),,,"['Oropharyngeal pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 973193,FL,79.0,F,"she tested positive COVID-19; she tested positive COVID-19; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect received from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), intramuscular on 10Jan2021 at single dose for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient experienced tested positive covid-19 on 12Jan2021. The patient underwent lab tests and procedures which included COVID test: unknow results on 10Jan2021, tested positive on 12Jan2021. Caller had a COVID test on Sunday morning and got the first dose of the vaccine on the same day. She received the results of the test today which turned out positive and wanted to know if she needs to repeat the first dose. Caller wanted to know if her testing positive was due to the efficacy of the vaccine or did she do something wrong or what. Caller verifies there are no other numbers besides EL1283 on her vaccine record card. The outcome of event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/12/2021,2.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH,OT 973210,SC,40.0,M,"Had COVID test/positive test result/Tested positive for COVID-19 after getting the initial dose of the vaccine; I am sick with COVID 19; This is a spontaneous report from a contactable other HCP. A 40-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration in left deltoid/left arm on 05Jan2021 at a single dose for covid-19 immunization. Medical history included ongoing high blood pressure diagnosed about 7 years ago and ongoing GERD that he had his entire life. There were no concomitant medications. The patient got the first vaccine on 05Jan2021, then tested positive for COVID-19. The patient added that he experienced fever of 103, body aches, headache, cough, fatigue, nausea and vomiting and diarrhea times one week.Had COVID test Friday, 08Jan2021 and positive test result received on Saturday, 09Jan2021. The outcome of the event was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/09/2021,4.0,UNK,,Blood pressure high (Verbatim: High blood pressure/Diagnosed about 7 years ago.); GERD (Verbatim: GERD/Has had this his entire life),,,,"['Cough', 'Diarrhoea', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive', 'Vomiting']",1,PFIZER\BIONTECH, 973211,,,F,"had a COVID test on Monday/test came back positive; had a COVID test on Monday/test came back positive; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a first dose of the Pfizer COVID-19 vaccine on Sunday and then had a COVID test on Monday as part of a pre-surgery test and her test came back positive but she does not have symptoms. She would like to know if the vaccine can cause you to test positive for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 973215,,34.0,F,"developed symptoms of COVID-19 infection on 24Dec2020/tested positive to COVID-19 on 29Dec2020; developed symptoms of COVID-19 infection on 24Dec2020/tested positive to COVID-19 on 29Dec2020; This is a spontaneous report from a non-contactable pharmacist. A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID-19 vaccine on 21Dec2020, developed symptoms of COVID-19 infection on 24Dec2020, and tested positive to COVID-19 on 29Dec2020. The reporter asked for recommendations on how to proceed with the second dose. She then specified her request asking whether the patient should receive the second dose, or repeat the vaccination series. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A causal association between suspect BNT162B2 and reported event cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/24/2020,3.0,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 973225,CA,52.0,M,"his brain was still a little cloudy; tested positive for covid; tested positive for covid; lost 10 pounds; energy level changed drastically; weak; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EH9899, via an unspecified route of administration in left arm on 21Dec2020 09:00 at a single dose for COVID-19 immunization in a hospital. Medical history included hypertensive and diabetic, both ongoing. Concomitant medication included metformin for diabetic and olmesartan medoxomil (BENICAR) for hypertensive. There were no prior vaccinations within 4 weeks. The patient received the covid vaccine first dose on 21Dec2020 and started developing covid symptoms on the 27Dec2020. He was tested positive for covid on the 28Dec2020. The patient wanted to know what is next. He patient stated that it has been 10 days and he wanted to know if he is still contagious. He is scheduled to get the second dose on 11Jan2021. He wonders if he can get the second dose or does have to start the process over again. He works in a doctor's office. He is a technician. While providing height and weight he commented it has changed drastically. He later clarified it was his weight that changed drastically. He lost ten pounds. His weight and energy level changed drastically, and this was after getting the COVID Vaccine. His symptoms started the weekend after taking the vaccine. He had COVID symptoms. He later clarified and stated they all started on 27Dec2020. He clarified his symptoms as: body aches and fever. The body aches and fever started the night of 27Dec2020 and recovered from 08Jan2021. He was unable to provide an exact time of onset. These have resolved, but at the time of report he was just weak. He had a COVID test done on 28Dec2020 he tested positive. He confirmed he has not had a follow-up COVID test done afterwards. The patient also mentioned that his brain was still a little cloudy since an unspecified date. The patient had not recovered from the event weak; while outcome of ""lost ten pounds"", ""his brain was little cloudy"" and ""tested positive for covid"" was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/27/2020,6.0,PVT,METFORMIN; BENICAR,Diabetic; Hypertensive,,,,"['Asthenia', 'Feeling abnormal', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive', 'Weight decreased']",1,PFIZER\BIONTECH, 973226,MN,31.0,F,"tested positive for COVID-19; tested positive for covid-19; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration on 24Dec2020 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient received the first dose of vaccine on 24Dec2020 and tested positive for COVID-19 on 11Jan2021. She was scheduled for second dose on 14Jan2021. The patient was asking if she can get her second dose as scheduled or wait and recommendation for 2nd dose, if needing to extend past 3 week mark for quarantine after testing positive. Outcome of the events was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,01/11/2021,18.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 973232,VA,,M,"stated that he was scheduled for his second vaccine and tested positive for Coronavirus the same day; stated that he was scheduled for his second vaccine and tested positive for Coronavirus the same day; This is a spontaneous report from a contactable physician. A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at a single dose (first COVID vaccine) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was scheduled for the second dose on 06Jan2021 and tested positive for Coronavirus the same day. He started showing symptoms on 03Jan2021 and wanted to know, since he could not do the second Covid vaccine, because he is in quarantine and when he can get it. His quarantine ends on Friday and hopes to do it on that day. Clarified that it was 04Jan2021 that he was scheduled for the second dose and tested positive for the Coronavirus the same day and not 06Jan2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 04Jan2021. The outcome of the events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between suspect BNT162B2 and reported event cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,,,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 973266,,,F,"Received the vaccine 2 weeks ago and came down with COVID; Received the vaccine 2 weeks ago and came down with COVID; This is a spontaneous report from a contactable Physician. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unknown date in 2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine 2 weeks ago, unknown date in 2020 and came down with COVID on an unknown date. The outcome of the event was recovered on an unspecified date. Information on Lot/Batch number has been requested; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 973267,CA,45.0,M,"brain is still in a fog; received the first dose of the Pfizer COVID Vaccine and then 2 weeks later got COVID again; received the first dose of the Pfizer COVID Vaccine and then 2 weeks later got COVID again; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140 and expiry date: Mar2021), via an unspecified route of administration on 19Dec2020 at single dose for Covid-19 immunization and tetanus vaccine (manufacturer unknown) via an unspecified route of administration on unspecified date at single dose for immunization. Medical history included COVID diagnosed in Mar2020. Concomitant medication was not reported. The patient received the first dose of the Pfizer COVID Vaccine and then 2 weeks later on 05Jan2021 got COVID again. He wanted guidance as to when he can get the second dose of the vaccine. His vaccination provider refused his second dose and the 21-day interval has passed. He was tested for COVID on 05Jan2021 and was positive. The patient said that his brain is still in a fog on unspecified date. He is normally not this cloudy. It was also reported that around the same time he got a Tetanus shot, and he can not remember which one was given in which side. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/19/2020,01/05/2021,17.0,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['COVID-19', 'Feeling abnormal', 'Inappropriate schedule of product administration', 'SARS-CoV-2 test positive']",UNK,UNKNOWN MANUFACTURER, 973273,,,F,"contracted Sars-Cov-2 in the interim/tested positive for vaccine; contracted Sars-Cov-2 in the interim/tested positive for vaccine; This is a spontaneous report from a non-contactable Other HCP. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received the first dose 24Dec2020 and is due for 2nd dose 13Jan2020 but contracted Sars-Cov-2 in the interim. She reports that she is currently symptomatic, but her employer will allow her to return to work after a 10-day quarantine. And then 07Jan2021 tested positive and a couple of days to me asymptomatic No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,01/07/2021,14.0,UNK,,,,,,"['COVID-19', 'Impaired work ability', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 973281,TX,48.0,F,"I regained my taste. I had Covid 31Dec-10Jan with both loss of smell and taste initially. My smell returned quickly but after the 2nd vaccine my taste returned the next day; I had Covid 31Dec-10Jan with both loss of smell and taste initially.; This is a spontaneous report from a contactable nurse (patient). A 48-years-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot-number: EL0104), via an unspecified route of administration in the right arm on 21Dec2020 at 03:00 at a single dose, and the second dose (Lot number: EL3249) via an unspecified route of administration in the right arm on 11Jan2021 at 03:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination, did not have any other vaccine within four weeks, and did not have COVID prior to the vaccination. The patient's concomitant medications were not reported. The patient previously took sertraline (ZOLOFT) and experienced drug hypersensitivity. The patient stated that she regained her taste. She had COVID from 31Dec-10Jan (also reported as on 12Jan2021 at 12:00) with both loss of smell and taste initially. Her smell returned quickly but after the second vaccine, her taste returned the next day. The patient underwent lab tests and procedures which included viral test (nasal swab; Sofia COVID test): positive on 04Jan2021. The patient received no treatment for the events. Outcome of the events was recovered.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/31/2020,10.0,UNK,,,Medical History/Concurrent Conditions: Hypothyroidism,,,"['Ageusia', 'Anosmia', 'COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 973295,FL,57.0,F,"Patient reported during her 15 minute observation to the medic that she is feeling dizzy and her heart is racing. Patient was taken to the medic location. VS= 192/116, HR 152, O2 sat=99%",Not Reported,,Not Reported,Yes,,Not Reported,U,01/25/2021,01/25/2021,0.0,PUB,Losortoan 50,none per patient,High blood pressure,,none per patient,"['Dizziness', 'Electrocardiogram abnormal', 'Palpitations', 'Tachycardia']",1,PFIZER\BIONTECH,IM 973299,NV,72.0,M,"severe angioedema resulting in intubation to protect his airway and ICU admission. pt recieved the 2nd dose at 0755 am, woke up from a nap at 2200 the same night with tongue swelling.",Not Reported,,Yes,Yes,,Not Reported,U,01/25/2021,01/25/2021,0.0,PVT,"lantus, gabapentin, regular insulin, sertraline, sevelamar, cinacalcet, bumetadine, calcium acetate, vitiman E, atovorstatin",none,"stage 5 chronic kidney disease, diabetes melitis, diabetic neuropathy, gout, anemia, hyperkalemia, ptsd, GERD",,"hydralazine caused flushing, varenicline caused nausea","['Angioedema', 'Endotracheal intubation', 'Intensive care', 'Swollen tongue']",2,PFIZER\BIONTECH,IM 973301,,,F,"Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a non-contactable consumer (patient's daughter) reported that a female patient (aged 102, no unit reported) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 at a single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's daughter was calling on behalf of her mother, aged 102, received vaccine a week ago last Sunday (03Jan2021), and was tested positive for Covid the next day (04Jan2021). The patient was due for her second vaccine and wanted to know if her mother is still eligible to receive vaccine. No follow-up attempts are possible. Information about batch/lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/04/2021,1.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 973307,MA,,F,"cold symptoms; leg pain; Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Covid vaccine on 03Jan2021 and tested positive for COVID on 05Jan2021. She further reported that she is still experiencing some cold symptoms and leg pain on an unspecified date. She is scheduled for second dose on 24Jan2021. She is still on precautions. She does not think she should get it. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Jan2021. Therapeutic measures were taken as a result of the events which included treatment with Tylenol. The patient did not recover from cold symptoms and leg pain while the outcome of the other events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/05/2021,2.0,UNK,,,,,,"['Nasopharyngitis', 'Pain in extremity', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 973313,,,F,"received her first dose of the COVID-19/now testing positive; received her first dose of the COVID-19/now testing positive; This is a spontaneous report from a contactable other HCP. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient was now testing positive for Covid-19 at the hospital she works at regularly. She was not sure what test she had done, i.e. antibody or virus. The outcome of events was unknown. Information about batch/lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 973318,,,F,"got the first dose of the covid vaccine/tested positive with covid; tested positive with covid; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on an unknown date, at single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. She was positive with covid and is asking when she could get the second shot of the vaccine. The outcome of event was unknown. Information about Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 973339,,,F,"Tested positive for Covid; Tested positive for Covid; This is Spontaneous report from a Non-contactable Consumer reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient and her husband received the Covid vaccine last Friday (08Jan2021) and the patient was positive for Covid 19 on Monday (11Jan2021). She was wondering whether she should get the second shot. The outcome of the event was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034217 same reporter, diff patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/11/2021,3.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 973346,TN,,F,"Caller is COVID positive after taking the first dose; Caller is COVID positive after taking the first dose; got sick; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 31Dec2020 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID), duloxetine hydrochloride (CYMBALTA), vitamin C, vitamin E, propanolol hcl and clonazepam (KLONOPIN). Reporter is a social worker at a community center for pediatrics. She had the first dose of the COVID-19 vaccine on 31Dec2020. However, she got sick past Sunday (03Jan2021) and tested positive for COVID-19. She was wondering if there is a chance that the vaccine caused the positive result for the COVID test. Consumer stated, ""I had a question about the COVID vaccine and I had the COVID vaccine administered on let's say it was 31Dec and I felt sick over the weekend and ended up having to take a COVID test. Well, the COVID test came out positive for COVID. And so my question is because I had the vaccine could the vaccine maybe cause a false positive test?"" The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unspecified date (Caller is COVID positive after taking the first dose). The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/03/2021,3.0,UNK,SYNTHROID; CYMBALTA; Vitamin C; Vitamin E; Propanolol HCl; KLONOPIN,,,,,"['Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 973349,,,F,"heart rate went up to the 120s or 150s; chills; fever; This is a spontaneous report from a contactable healthcare professional (HCP [patient]). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 31Dec2020 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the first dose of the COVID-19 vaccine last 31Dec2020 and did not have any immediate adverse effect. During the night of 31Dec2020, she experienced chills and fever, but the patient wasn't concerned because she knows other people experience it too: some individuals she knew were getting, the fever (could not be clarified further). She was concerned since she had fast heartbeat. Her heart rate went up to the 120s or 150s (ranging to 120s to 140s, 150s). She was concerned if she should go to the hospital to get an IV bolus. Patient had to go to the ER and they gave her some IV Bolus. Patient asked if she should be concerned about the second dose. The outcome of the events was unknown. Information on the batch number/lot number has been requested.; Sender's Comments: Based on a compatible temporal association, a causal relationship between event ""heart rate went up to the 120s or 150s"" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,12/31/2020,0.0,UNK,,,,,,"['Chills', 'Heart rate increased', 'Pyrexia']",1,PFIZER\BIONTECH, 973350,,,F,"received COVID vaccine first dose on 21Dec2020. 10 days later I was diagnosed with COVID; received COVID vaccine first dose on 21Dec2020. 10 days later I was diagnosed with COVID; dizziness; nausea; vomiting; diarrhea; This is a spontaneous report from a contactable pharmacist (reported for herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received COVID vaccine first dose on 21Dec2020. 10 days later (31Dec2020), the patient was diagnosed with COVID. Her work cancelled her second COVID vaccine until she was symptom free. The patient asked when she should receive her 2nd COVID vaccine. The patient also had a reaction to the first COVID vaccine (dizziness, nausea, vomiting, diarrhea) about 1.5 hours after getting the vaccine at her work on 21Dec2020. She was worried about having strong reaction to 2nd dose since she actually had COVID. The outcome of the events was unknown. Information on the batch/lot number has been requested.; Sender's Comments: The subject received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020, and 10 days later she was diagnosed with COVID. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the reported COVID likely represents a pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/21/2020,0.0,UNK,,,,,,"['COVID-19', 'Diarrhoea', 'Dizziness', 'Nausea', 'SARS-CoV-2 test positive', 'Vomiting']",1,PFIZER\BIONTECH, 973351,NC,35.0,M,"pain on swallowing in the throat; throat started feeling itchy; pins and needles feeling; throat was swollen; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL0140, expiry date unknown), via an unspecified route of administration on the left arm on 12Jan2021, 9:00AM at a single dose for COVID-19 immunization. The patient's medical history included asthma and allergies to Amoxicillin, Quinolones, and Sulfa drugs, all from an unknown date and unknown if ongoing. Concomitant medications included colecalciferol (VITAMIN D) and cyanocobalamin (VITAMIN B 12); patient received these medications with two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 12Jan2021, 19:00, just after evening, patient's throat started feeling itchy and had pins and needles feeling. Gradually the symptoms increased in intensity and in the night of 12Jan2021 (time unspecified), he felt like his throat was swollen. It was also reported that patient woke up today, 13Jan2021 with the same feeling and there is pain on swallowing in the throat. No therapeutic measures were taken in response to the events. Outcome of the events was reported as recovering.; Sender's Comments: Based on a chronological association, causality between events odynophagia, pharyngeal swelling and throat irritation and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,SEN,VITAMIN D [COLECALCIFEROL]; VITAMIN B 12 [CYANOCOBALAMIN],,Medical History/Concurrent Conditions: Allergic reaction to antibiotics; Asthma,,,"['Odynophagia', 'Paraesthesia', 'Pharyngeal swelling', 'Throat irritation']",1,PFIZER\BIONTECH, 973356,,,F,"Tested positive; Tested positive; This is a spontaneous report from a contactable pharmacist. A (23 unknown unit) female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 04Jan2021, at single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Patient received the covid 19 vaccine on 04Jan2021 and tested positive on 11Jan2021, when should patient receive the second dose. The outcome of event was unknown. Information about Lot/Batch has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 04Jan2021, and COVID-19 test positive on 11Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID test possibly represents a pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/11/2021,7.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 973367,FL,83.0,F,"her blood pressure is 188/90; bad headache; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in right arm on 10Jan2021 at a single dose for protection from the virus. Medical history included a month ago on Dec2020, she fell on her right knee and has gotten a shot in her knee for pain. She was going to chiropractor and then started going to an orthopedic doctor. That is when she got a shot in her knee. She had an appointment with her doctor on 29Dec2020. She had labs a week prior. The patient's concomitant medications were not reported. The patient received Covid-19 vaccine on Sunday, 10Jan2021. Yesterday, 12Jan2021, she started having a bad headache. She took Tylenol and it went away. This am of 13Jan2021 at 7:00am, she started having a terrible headache. She also checked her blood pressure and it was 188/90. She took Tylenol around 7:15-7:30. She still has a headache. The outcome of the event headache was not recovered. the outcome of the event blood pressure and it was 188/90 was unkown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/12/2021,2.0,UNK,,,Medical History/Concurrent Conditions: Fall (Verbatim: fell on her right knee); Knee pain,,,['Headache'],UNK,PFIZER\BIONTECH, 973368,MI,72.0,F,"her brain is going blank; back pain that occurs in her left leg past the knee until the top of her foot; back pain that occurs in her left leg past the knee until the top of her foot; She wanted to know if it is like a sciatic nerve pain she is experiencing; she just thought it was swelling in her spine; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EK9231, via an unspecified route of administration in left shoulder on 11Jan2021 at a single dose for covid-19 immunization. Medical history included other problems before taking the COVID-19 vaccine such as joint pain, muscle pain, back pain, spinal stenosis, has a lot of back issues, like sciatic has a lot of problems. There were no concomitant medications. The patient had the COVID-19 vaccine on Monday (11Jan2021). On Tuesday (12Jan2021), she experienced back pain that occurs in her left leg past the knee until the top of her foot. She also mentioned that she had other problems before taking the COVID-19 vaccine such as joint pain, muscle pain, back pain, and spinal stenosis. She wanted to know if the COVID-19 vaccine can cause the adverse event that she experienced. She wanted to know if it is like a sciatic nerve pain she is experiencing. The patient stated it may sound crazy, but she got the COVID 19 vaccine on Monday, she is 72 years old, and has a lot of back issues, like sciatic has a lot of problems, and she got the shot and Tuesday) morning, her back hurt so bad, down into her sciatic, into her butt, leg, her lower leg and as far as her foot, the top of her foot, and she doesn't know if this is something that was going to happen, she read about joint pain, tiredness, that would include joints in the back, she would expect. She wonders if she is out of her head, since it was the very next morning, this was Tuesday, and instantly, she was sitting with ice and trying to get ahold of her healthcare person, she gets pain shots in her back, but she hasn't had them in a couple years, she was going along pretty good, then this was bad enough, it is in her thigh and leg, and is always under her foot, and she just thought it was swelling in her spine. She wonders if it is a side effect or her imagination. When asked for address, the patient stated her brain is going blank. She stated this may be just her. She has bad back problems, and was going along pretty good, it has been a year or two since she has had any kind of anything. But this was a good one, a strong one, the ice hurts so bad. She woke up with it, it is staying the same- after having something like this, she was trying to get ahold of the pain clinic, to get a shot, but that may be 3-4 weeks out. She has had no blood work in a while. Outcome of the events ""she just thought it was swelling in her spine"" and ""her brain is going blank"" was unknown; while not recovered for other events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/12/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Back disorder; Back pain; Joint pain; Muscle pain; Sciatica; Spinal stenosis,,,"['Back pain', 'Condition aggravated', 'Feeling abnormal', 'Musculoskeletal pain', 'Pain in extremity', 'Sciatica']",1,PFIZER\BIONTECH, 973375,,,F,"tested positive; tested positive; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to obtain information for receiving the second dose if she tested positive after receiving the first dose. She received the first dose on 21Dec2020, was exposed on 26Dec2020, tested positive on 02Jan2021 and went to the ER but was now feeling better. She wanted to know if she can still get the second vaccine. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,01/02/2021,12.0,UNK,,,,,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 973382,SC,,F,"Tested positive for covid 19; Tested positive for covid 19; missed the second dose at the 21-day mark and wants to know if it is okay to get the vaccine a week later; This is a spontaneous report via a Pfizer-sponsored program, Pfizer First Connect from a contactable nurse. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter stated she tested positive for COVID 19 after receiving the COVID 19 vaccine. She missed the second dose at the 21-day mark and wants to know if it is okay to get the vaccine a week later. She got sick and was tested positive after the vaccine. She's about to take the 2nd dose and wondering if she still has to take it or not. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Inappropriate schedule of product administration', 'Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 973413,,,M,"6 days after the first dose he received a diagnostic with a positive test for COVID-19; 6 days after the first dose he received a diagnostic with a positive test for COVID-19; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient called that he was administered with the first dose of Pfizer's COVID-19 vaccine on 28Dec2020 and 6 days after (03Jan2021) the first dose, he received a positive result for a COVID-19 laboratory test. He started with symptoms of COVID-19 between 4 to 6 days after the administration of the vaccine and he had scheduled the second dose of the vaccine in 2 days (at the time of report). He had been quarantined appropriately after being diagnosed. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/03/2021,6.0,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 973424,NC,39.0,F,"Sore arm; a little tired; second dose was due 25Jan2021; Tested positive for COVID-19 on 03Jan2021/congestion and cough; Tested positive for COVID-19 on 03Jan2021/congestion and cough; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). This 39-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via intramuscular at left deltoid on 28Dec2020 11am at single dose for COVID-19 immunization. Medical history included non-smoker with no other illness. Concomitant medication was none. The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. Patient reported after receiving her first dose of the COVID-19 vaccine on 28Dec2020, she had sore arm and a little tired, other than that felt fine. She stated second dose was due 25Jan2021. She was tested positive for COVID-19 (Rapid Covid testing) on 03Jan2021. She already decided going to wait the 90-day-period to get the second dose of the vaccine. Since she was quarantined she wanted to what she should do. She stated her having testing positive for Covid did not have anything to do with the vaccine. She still had some lingering symptoms, congestion and cough. Nothing had worsened, but just wouldn't go away. She did not receive any other vaccines the same day or 4 weeks prior. No history of problems with vaccines in past. She had not had antibodies checked yet. It was reported no AE required a visit to emergency room/physician office. The patient was not hospitalized. The patient received no additional therapies for COVID-19. Patient's outcome with COVID-19 was recovering, and the rest of events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tested positive for COVID-19 (Rapid Covid testing), which is considered ineffective of BNT162B2, and the administration of BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/03/2021,6.0,UNK,,,Medical History/Concurrent Conditions: Non-smoker (no other illness),,,"['Cough', 'Fatigue', 'Pain in extremity', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 973433,TX,61.0,F,"Tested positive for Covid 19 after receiving the vaccine/illness; Tested positive for Covid 19 after receiving the vaccine/illness; This is a spontaneous report from a contactable consumer (patient) from the Pfizer-sponsored program, Pfizer First Connect. A 61-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EL0140, expiration date: 31Mar2021), via an unspecified route of administration on the upper left arm on 22Dec2020 at a single dose for COVID-19 immunization. There was no medical history and no concomitant medications. The patient received her first dose of the COVID-19 vaccine on 22Dec2020. On 31Dec2020, the patient tested positive for COVID-19. The patient was scheduled to receive her second dose and wanted to know if it is okay to get it, clarified that she was supposed to receive her second shot on 12Jan2021 (the day before the report). The doctor gave her a script that showed that she clinically recovered from illness and okay to get the second vaccine (dose). No treatment was administered for the event. The event ""tested positive for COVID-19 after receiving the vaccine/illness"" resolved on 13Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/31/2020,9.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Inappropriate schedule of product administration', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 973442,,,F,"The patient developed symptoms on 25Dec2020, tested positive on 31Dec2020; She was supposed to receive second vaccine on 06Jan2021, but put it off; The patient developed symptoms on 25Dec2020, tested positive on 31Dec2020; This is a spontaneous report from a other HCP. A female patient (Age: 45, Unit: Unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed symptoms on 25Dec2020, tested positive on 31Dec2020. She was supposed to receive second vaccine on 06Jan2021, but put it off because she was told by Pfizer she had to wait 90 days. She was calling for guidance because her hospital was telling her she was eligible to receive the vaccine. She already filed a report with safety when she initially developed symptoms that included loss of smell, taste and headaches. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,12/25/2020,9.0,UNK,,,,,,"['Ageusia', 'Anosmia', 'Headache', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 973449,NJ,63.0,F,"lost a lot of weight, but still plump; tightness in chest; Upper chest tightness with post nasal drip, like the flu; got Covid virus/ Covid PCR testing: positive; got Covid virus/ Covid PCR testing: positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EJ1685) via an unspecified route of administration on left arm on 24Dec2020 11:00 at single dose for COVID-19 immunisation. Medical history included ongoing asthma, ongoing allergies. She was asthmatic and believed that the virus would have affected her differently if she didn't get the vaccine. If she was to catch the virus and didn't have the vaccine she may not have come out of it. The patient's concomitant medications were not reported. The patient denied getting any other vaccines that day or 4 weeks prior. No problems with vaccines in past. Received the COVID vaccine at her workplace. The patient got COVID virus on 07Jan2021. It was also reported that the patient lost a lot of weight, but still plump, coughing, tightness in chest, upper chest tightness with post nasal drip, like the flu, body aches, all on an unspecified date. Emergency room visit needed for the events (body aches, runny nose). The patient underwent lab tests and procedures which included Covid PCR testing: negative on 04Jan2021, positive on 07Jan2021, rapid COVID testing: negative on 01Jan2021. The outcome of the event (got COVID virus) was not recovered, of other remain events was unknown. Clinical course: The patient received the first dose of BNT162B2 on 24Dec2020, and a couple weeks later she got the COVID virus (07Jan2021). Mentioned she lost a lot of weight, but still plump. Probably be in the hospital now. Still had some coughing, tightness in chest, but it's not as bad. Upper chest tightness with post nasal drip, like the flu, runny nose in throat that goes down into the lungs and when it goes down she coughs and hacks to get rid of it. Went to the doctor office on the 01Jan2021 and did a rapid test and it was negative. Then on 04Jan2021 she did another PCR Covid test and it was negative. On 07Jan2021 she had symptoms and was insistent on getting another test since having body aches, runny nose. Got the re-test and it came back positive when she went to the emergency room. Got the PCR test. The patient thought that the way they were testing is how it's spreading. Did the testing on the 04Jan2021 and they used a swab bigger than a cue tip, it was huge and couldn't get far up enough instead of the tiny ones. On the 07Jan2021 at her job, emergency room, they had the tiny ones and was able to go further up and that's when she tested positive. Mentioned using salbutamol (ALBUTEROL) nebulizer, over the counter cough syrup, prescription azelastine hydrochloride;fluticasone propionate (DYMISTA) nasal spray, and pseudoephedrine hydrochloride (SUDAFED). When has the dry cough she uses the ALBUTEROL nebulizer with the machine and vials at home and that slows down the coughing a lot and the other stuff with the lungs. Not taking any steroids. Using SUDAFED to stop the runny nose from post nasal drip from going into lungs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,01/07/2021,14.0,PVT,,Allergy; Asthmatic,,,,"['COVID-19', 'Chest discomfort', 'Cough', 'Influenza like illness', 'Pain', 'Rhinorrhoea', 'SARS-CoV-2 test positive', 'Upper-airway cough syndrome', 'Weight decreased']",1,PFIZER\BIONTECH, 973475,PA,,F,"tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer (patient 's mother). This consumer reported same event for 2 patients. This is the 1st of 2 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for COVID on 12Jan2021 with outcome of unknown. Event was assessed as non-serious by reporter. Information on lot number/batch number was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021035102 Same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,01/12/2021,27.0,PVT,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 973492,NY,,F,"Tested positive after 7 days of taking the vaccine; Tested positive after 7 days of taking the vaccine; This is a spontaneous report from a contactable Pharmacist. A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient tested positive after 7 days of taking the vaccine. Patient also received the ""Bam antibodies"", monoclonal antibody. Outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (tested positive) with BNT162b2 can not be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 973541,,,U,"the patient got a positve COVID-19 test result; the patient got a positve COVID-19 test result; This is a spontaneous report from a contactable other healthcare professional (hcp). This hcp reported the same events for 2 patients. This is the second of two reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got a positve COVID-19 test result on 05Jan2021. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021020999 same drug/events/reporter, different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/05/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 973561,NV,,M,"He tested positive for Covid- 3 days without symptoms; He tested positive for Covid- 3 days without symptoms; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect, by a contactable consumer (patient). This male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 22Dec2020 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Jan2021, the patient tested positive for Covid, 3 days without symptoms with outcome of unknown. He asked if it's okay to get the second dose. The patient underwent lab tests and procedures which included Sars CoV-2 test: positive on 06Jan2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,01/06/2021,15.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 973562,CA,,F,"tested positive; tested positive; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect via a contactable female nurse reported for herself. The female patient of an unspecified age received first dose BNT162B2(Covid-19) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested positive after she got the 1st vaccine, and got sick, both in Jan2021. Outcome of events was unknown. Information about Lot/Batch has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/01/2021,,UNK,,,,,,"['Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 973597,PA,,U,"tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer. This consumer reported same event for 2 patients. This is the second of 2 reports. A patient of an unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for COVID on 12Jan2021 with outcome of unknown. Event was assessed as non-serious by reporter. Information on lot number/batch number was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021028267 Same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/16/2020,01/12/2021,27.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 973600,TX,51.0,F,"diagnosed with Covid-19 after the 1st dose; diagnosed with Covid-19 after the 1st dose; Pneumonia; Fever; Body aches; swollen lymph nodes under left armpit; Exposed to COVID; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that a 51-year-old female patient received the first does of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 08:30 in left arm at single dose for covid-19 immunization. The patient medical history was none. Family medical history was no. Patient had been taking vitamin supplements. No vaccinations were taken within 4 weeks. Patient received first COVID-19 Vaccine on 21Dec2020 around 08:30. Between that three weeks period, patient was diagnosed with COVID. Patient was exposed the following weekend. Took four tests to finally test positive within a four-day-span. Patient was exposed to COVID on 26Dec2020. On 28Dec2020, patient experienced swollen lymph nodes under left armpit. Progressively got more sensitive on 29Dec2020. Patient thought maybe it was a side effect of the COVID-19 Vaccine. Wednesday morning, 30Dec2020, around 10:00 patient noticed body aches. Around 12:00 patient noticed a fever. On 30Dec2020, patient had a 24-hour lab test to check for COVID. All other COVID tests performed were rapid tests. First COVID test was on 30Dec2020. Patient had another COVID test on 31Dec2020, and two COVID tests on 02Jan2021. Patient was tested positive for COVID on 02Jan2021. COVID test that resulted positive was a rapid test in the emergency room. Patient was diagnosed with Covid-19 after the 1st dose. Patient was in the emergency room with pneumonia which occurred on 02Jan2021. It was confirmed patient was discharged from the emergency room six to seven hours after arrival. Lot number from patient card was either EJ1685 or ET1685. Caller unable to confirm lot number from patient card. Chest X-ray was what sent her to emergency room labs and blood work done on 02Jan2021 in emergency room. Labs were done in clinic a couple days before flu and strep test both negative on an unspecified date. Patient didn't remember all tests and results. Outcome of all events were unknown. Caller would like to know whether she should take the 2nd dose or not. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/21/2020,12/26/2020,5.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Blood test', 'COVID-19', 'Chest X-ray', 'Exposure to SARS-CoV-2', 'Influenza virus test negative', 'Laboratory test', 'Lymph node pain', 'Lymphadenopathy', 'Pain', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test positive', 'Streptococcus test negative']",1,PFIZER\BIONTECH, 973644,,,F,"She have her first dose of the COVID vaccine; She had a positive COVID test; She have her first dose of the COVID vaccine; She had a positive COVID test; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age reported she received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported she have her first dose of the covid vaccine; and had a positive covid test on 31Dec2020. The patient underwent lab tests and procedures which included COVID test: positive on 31Dec2020. The event outcome was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/20/2020,12/31/2020,11.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 973662,CA,,F,"diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for self. This female patient received the first dose of BNT162B2 (reported as COVID-19 Vaccine, lot number unknown) via unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the first dose of COVID-19 vaccine on 07Jan2021 and tested positive with COVID-19 on 13Jan2021. The patient was diagnosed with COVID-19 on 13Jan2021. The outcome of event was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/13/2021,6.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 973669,,,M,"pneumonia; flu; Initial information was received on 19-Nov-2020 regarding an unsolicited valid serious case from the physician via non-healthcare professional. This case involved an adult male patient (age was not specified) who had pneumonia and flu (influenza), after he received INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination. On an unknown date, the patient developed serious pneumonia and flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE. The event of pneumonia was assessed as medically significant. It was unknown if there were lab data/results available. It was not reported if the patient received any corrective treatment. At the time of reporting, the outcome of the events was unknown. Information on the batch number was requested.; Sender's Comments: This case concerns an adult patient who presented with pneumonia and influenza, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. The patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Influenza', 'Pneumonia']",UNK,UNKNOWN MANUFACTURER,OT 973670,,84.0,M,"Issue from a flu shot that caused him to be paralyzed; Issue from a flu shot that caused him to be paralyzed; This spontaneous case was retrieved on 13-Jan-2021 via Novartis (reference number: NVSC2021US006533), reported by other non-health professional (consumer) and concerned an 84-year-old, male patient. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported. On an unspecified date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced an issue which caused him to be paralyzed. The outcome of events was not reported. The reporter assessed events as related to influenza virus vaccine polyvalent, as it was reported that the patient was dealing with issue from flu shot that caused him to be paralyzed. The event of paralyzed was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department. Company comment: An 84-year-old patient was administered influenza virus vaccine polyvalent. On an unspecified date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced an issue which caused him to be paralyzed. Causality is unassessable for unevaluable event and paralysis, due to lack of information regarding events, temporal relationship with the suspect vaccine and diagnostic findings.; Reporter's Comments: The patient was dealing with issue from flu shot that caused him to be paralyzed.; Sender's Comments: An 84-year-old patient was administered influenza virus vaccine polyvalent. On an unspecified date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced an issue which caused him to be paralyzed. Causality is unassessable for unevaluable event and paralysis, due to lack of information regarding events, temporal relationship with the suspect vaccine and diagnostic findings.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Comments: None,,,['Paralysis'],UNK,UNKNOWN MANUFACTURER,OT 973673,NY,30.0,F,"Fever of 104, causing febrile seizure. Symptoms began approx. 12 hours after vaccination. Patient was hospitalized for observation for 15 hours.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/20/2021,01/21/2021,1.0,WRK,levothyroxine,,"hypothyroidism, OCD, depression, anxiety, anemia",,cephalexin,"['Febrile convulsion', 'Pyrexia']",2,PFIZER\BIONTECH,IM 973674,FL,75.0,F,Facial tingling BP 160/90 HR 85 Resp 18 trelegy prednisone ventolin,Not Reported,,Not Reported,Yes,,Not Reported,U,01/25/2021,01/25/2021,0.0,PUB,"Vitamin C, zinc",none,COPD,,none,['Paraesthesia'],1,PFIZER\BIONTECH,IM 973708,NE,91.0,F,"Resident experienced flash pulmonary edema at 2300 on 01/25/2021 with SOA, Overt coarse crackles to all lung fields, hypoxia on room air requiring 5LPM via NC, Hypertension (190/102). Resident was sent to Hospital where she was admitted for pulmonary edema.",Not Reported,,Yes,Yes,,Not Reported,N,01/25/2021,01/25/2021,0.0,SEN,"Acetaminophen, Carb/Levo Tab 25-100mg, Polyethylene Glycol, Vitamin D3, Systane eye drops, Oxybutynin, Elequis, Guaifenesin DM, Metoprolol Succinate, Levothyroxine, Furosemide",,"Parkinson's Disease, Acute Kidney Failure, Essential Hypertension, Hypothyroidism, Dorsalgia, Overactive Bladder, Anemia, Dry eye syndrome of bilateral lacrimal glands, Nonexudative Age-related macular degeneration,",,"Penicillins, Sulfa Antibiotics","['Acute pulmonary oedema', 'Hypertension', 'Hypoxia', 'Rales']",2,PFIZER\BIONTECH,IM 973823,NH,78.0,M,New onset atrial fibrillation that resolved in 1-2 hours after treatment in ER with Amlodipine and Metaprolol. Observed overnight. No symptoms since.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/30/2020,01/10/2021,11.0,PVT,"Tamulosin, Ibuprofen",,Asthma,,"Avodart, Latex","['Atrial fibrillation', 'Computerised tomogram thorax normal', 'Echocardiogram normal', 'Fibrin D dimer increased']",1,PFIZER\BIONTECH,IM 973889,CT,65.0,M,"Systemic: Other- unknown, depot store received call from facility on 1/22 that patient passed around 7pm",Yes,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,SEN,,,,,none,['Death'],1,PFIZER\BIONTECH,IM 973957,NC,81.0,M,5 days after receiving his COVID vaccination the patient had a spontaneous (nontraumatic) subarachnoid hemorrhage which was fatal. The patient had previously been stable on his coumadin dosing with therapeutic INRs for the past several months per his wife. At time of presentation his blood pressure in the ER was elevated to 223/94 and his INR was risen to 3.1,Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/24/2021,4.0,UNK,pantoprazole 40 mg daily potassium chloride 10 meq daily sotalol 120mg BID warfarin 2.5mg daily warfarin 5mg weekly furosemide 40mg daily allopurinol 200 mg daily donepezil 10mg daily lisinopril 5mg daily,none,"atrial fibrillation, hypertension, GERD, prostate cancer",,penicillin,"['Activated partial thromboplastin time shortened', 'Blood pressure increased', 'Computerised tomogram head abnormal', 'Death', 'International normalised ratio increased', 'Platelet count normal', 'Prothrombin time prolonged', 'Subarachnoid haemorrhage', 'Subdural haemorrhage']",UNK,UNKNOWN MANUFACTURER, 973966,FL,82.0,M,death,Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,PHM,"Toujeo 300 unit/ml,trulicity 3mg/0.5ml, hydrochlorthiazide 12.5mg, actos 45mg, onglyza 2.5mg, olmeprazole 40mg, repaglinide 1mg, olmesartan 40mg, simvastatin 40mg, amlodipine 10mg",,diabetes,,,['Death'],UNK,MERCK & CO. INC.,IM 973994,IN,36.0,F,Fever chills body aches headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,PVT,"Zoloft , trulance",None,None,,None,"['Chills', 'Headache', 'Pain', 'Pyrexia']",2,MODERNA,SYR 974009,IL,48.0,F,"abd pain that began on 1/15/2021, 1/19/2021 admitted to hospital with Acute appendicitis with perforation",Not Reported,,Not Reported,Yes,7.0,Not Reported,,01/12/2021,01/15/2021,3.0,UNK,,,,,,"['Abdominal pain', 'Appendicitis', 'Appendicitis perforated']",2,PFIZER\BIONTECH,IM 974033,IN,69.0,F,Resident deceased on 1/26 at 445am. No signs ahead of time.,Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/26/2021,13.0,SEN,,,"coronary artery disease, diabetes mellitus, hypertension, TIA, asthma, CVA stroke, anemia, peripheral neuropathy, heart failure, heart disease with congestion",,"Macrobid, depacote, sulfamethoxazole/trimethorpim, lisinopril, lyrica, sumatriptan succinate",['Death'],1,MODERNA,IM 974040,IA,86.0,F,"high fever, severe pain, dizziness, vomitting, internal bleeding, stroke, sepsis",Not Reported,,Yes,Yes,,Not Reported,N,01/22/2021,01/22/2021,0.0,PVT,elquis,None,"pacemaker, valve replacement",,None,"['Cerebrovascular accident', 'Dizziness', 'Internal haemorrhage', 'Pain', 'Pyrexia', 'Sepsis', 'Vomiting']",1,MODERNA,SYR 974068,DE,67.0,M,Sudden onset of severe abdominal pain with diarrhea and bloody stool/fluid on Wednesday 1/20/21. Very weak/lightheaded. To ER on evening of 1/21 - CT noted 2 Thrombi in each branch of portal vein and ischemic colitis of descending colon. No risk factors determined. Only change in life was Covid-19 Moderna vaccine. Other side effect from vaccine was only a sore are at injection site. Seen by surgery and hematology. Rapid Covid test was negative and wife's pcr Covid test was negative. As of today is feeling significantly improved but not yet taking PO and remains on heparin drip.,Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/16/2021,01/20/2021,4.0,PVT,dextroamphetamine Tums Vitamin D3,none,ADHD,,"Brazil and macadamia nuts, honey bees","['Abdominal pain', 'Asthenia', 'Colitis ischaemic', 'Computerised tomogram abnormal', 'Diarrhoea', 'Dizziness', 'Haematochezia', 'Injection site pain', 'Portal vein thrombosis', 'SARS-CoV-2 test negative']",1,MODERNA,IM 974074,FL,74.0,F,"Initially soreness around injection site later followed by vertigo, nausea and vomiting. which resolved after 48 hours. Dizziness continued and on fourth day I developed body aches, low grade fever (100.9) and nausea. which lasted for three days.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/14/2021,01/14/2021,0.0,OTH,Losartan 100mg Hydrochlorothiaz 25 mg Anastrazole 1mg Vit D3 1000 IU,,hypertension,,,"['Blood test', 'Chest X-ray', 'Computerised tomogram head', 'Dizziness', 'Electrocardiogram', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia', 'Vertigo', 'Vomiting']",1,PFIZER\BIONTECH,IM 974085,CT,19.0,F,"Patient developed bilateral leg pain, weakness , numbness and tingling within 36 hours of receiving vaccine. She was admitted to the hospital on 1/22/21 for Guillain - Barre Syndrome. She was treated with IVIG and is starting physical therapy today",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,01/21/2021,01/22/2021,1.0,PVT,Pantoprazole,GERD,none,,none known,"['CSF protein normal', 'CSF test normal', 'Full blood count normal', 'Guillain-Barre syndrome', 'Hypoaesthesia', 'Immunoglobulin therapy', 'Magnetic resonance imaging normal', 'Metabolic function test', 'Metabolic function test normal', 'Muscular weakness', 'Pain in extremity', 'Paraesthesia', 'Red blood cell sedimentation rate normal', 'SARS-CoV-2 test negative', 'Urine analysis normal']",2,PFIZER\WYETH,IM 974095,WI,88.0,M,Inpatient admission for the treatment of sepsis (peptostreptococcus suspected) source of the infection unknown.,Not Reported,,Not Reported,Yes,9.0,Not Reported,Y,12/30/2020,01/16/2021,17.0,PVT,acetaminophen (TYLENOL) 325 mg tablet Take 650 mg by mouth every 6 hours if needed. ? albuterol HFA (PROAIR HFA) 90 mcg/actuation inhaler Inhale 2 Puffs by mouth 4 times daily if needed for Shortness Of Breath or Wheezing. ? fluticasone-sa,Dementia w/ activity change,"Dementia, weakness, anemia, COPD, chronic atrial fibrillation, benign neoplasm of ear and external auditory canal,",,NKA,"['Blood lactic acid', 'Peptostreptococcus infection', 'Sepsis']",1,MODERNA,IM 974115,SC,,M,"double vision; right posterior cerebral artery stroke; vertigo; loss of balance; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not reported. On or around 20-JAN-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered sudden onset of double vision, vertigo and loss of balance. The patient was hospitalized and diagnosed with right posterior cerebral artery stroke. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to vaccination. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), he sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, he suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). The events were determined to be disabling. Upon internal review, the event of right posterior cerebral artery stroke was considered to be medically significant.",Not Reported,,Not Reported,Yes,,Yes,N,01/20/2017,,,UNK,,Routine health maintenance,,,,"['Balance disorder', 'Cerebral infarction', 'Cerebrovascular accident', 'Diplopia', 'Vertigo']",UNK,MERCK & CO. INC.,OT 974116,NY,71.0,F,"E-coli Urinary tract infection; whelps at site; pain at site; itching at site; redness at site; Discomfort; This case was reported by a physician via call center representative and described the occurrence of escherichia urinary tract infection in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included mepolizumab (Nucala) powder for injection for eosinophilic granulomatosis with polyangiitis. The patient's past medical history included walking difficulty (had difficulty walking up stairs) and difficulty breathing (had breathing dificullty). Concomitant products included sertraline hydrochloride (Zoloft), omeprazole, atorvastatin, hydrochlorothiazide, amlodipine, gabapentin (Gabapentine), budesonide + formoterol fumarate (Symbicort), beclometasone dipropionate (Qvar), prednisone and mycophenolic acid (Mycophenolate). In October 2020, the patient received the 1st dose of Shingrix. In November 2020, the patient started Nucala (subcutaneous) 300 mg cyclically. On an unknown date, the dose was changed to 300 mg cyclically. On 12th January 2021, the dose was changed to 300 mg cyclically. In November 2020, less than 2 months after receiving Shingrix, less than a week after starting Nucala and an unknown time after starting Macrobid, the patient experienced escherichia urinary tract infection (serious criteria GSK medically significant), injection site urticaria, injection site pain, injection site itching, injection site erythema and discomfort. The patient was treated with macrobid (nos) (Macrobid), ciprofloxacin (Cipro), benadryl (nos) (Benadryl) and celecoxib (Celebrex). The action taken with Nucala was unknown. On an unknown date, the outcome of the escherichia urinary tract infection, injection site urticaria, injection site pain, injection site itching, injection site erythema and discomfort were recovered/resolved. It was unknown if the reporter considered the escherichia urinary tract infection, injection site urticaria, injection site pain, injection site itching, injection site erythema and discomfort to be related to Shingrix and Nucala. Additional details were provifded as follows: The reporter was the patient's husband. The patient had difficulty walking up stairs and give out breath as a historical condition. The patient received 1st dose of Nucala(batch number EGPA) in November 2020 and 1st doe of Shingrix in October 2020. The patient received all three in the office and the 300mg has been in 3 seperate shots all in lower abdomen. The reporter stated that, 12 to 24 hours after the first injection she had an E-coli urinary tract infection. The patient received Macrobidbut the urinary tract infection returned, which led to drug ineffective. Less than 2 months after vaccination with Shingrix, the patient experienced escherichia urinary tract infection, injection site urticaria, injection site pain, injection site itching and injection site erythema. The day before reporting, the patient had eosinophils level as down to 1 percent. The patient received Cipro, Benadryl 25 mg, Celebrex 200mg as a treatment medication. The reporter stated that prior to 2nd and 3rd dose of Nucala, the patient received pre medication and had no issue with 2nd dose but had redness, itching and discomfort again but not as significant as the first time. The reporter stated that, prior to Nucala, but on a lot of other medications and inhalers, the patient's eosinophil level was 9 to 12, at the end of December. The reporter stated that, aafter starting Nucala the patient could walk up stairs without shortness of breath and breathing had improved by 80 percent. The patient received 2nd dose of Shingrix in December 2020. The reporter consented to follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,10/01/2020,11/01/2020,31.0,UNK,ZOLOFT; OMEPRAZOLE; ATORVASTATIN; HYDROCHLOROTHIAZIDE; AMLODIPINE; GABAPENTINE; SYMBICORT; QVAR; PREDNISONE; MYCOPHENOLATE; NUCALA,,Medical History/Concurrent Conditions: Difficulty breathing (had breathing dificullty); Walking difficulty (had difficulty walking up stairs),,,"['Eosinophil percentage', 'Escherichia urinary tract infection', 'Gait disturbance', 'Injection site discomfort', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site urticaria', 'Urticaria']",1,GLAXOSMITHKLINE BIOLOGICALS, 974138,GA,78.0,F,DEATH- NO OTHER INFORMATION KNOWN,Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,U,01/18/1920,01/23/2021,36896.0,PVT,UNKNOWN,UNKNOWN,UNKNOWN,,UNKNOWN,['Death'],1,MODERNA,IM 974172,WA,94.0,F,Resident passed away 1/25/2021 at 1048pm after the vaccine was given on 1/24/2021. Resident had been being monitored but death was not expected.,Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/25/2021,1.0,SEN,"guaiFENesin, aspirin, celexa, Buprenorphine, zinc, vitamin D, voltaren gel, miralax, hydralazine, ascorbic acid, coreg, tramadol, metolazone, melatonin, potassium, gabapentin, senna, magnesium, ocuvite, losartan potassium, doss, vitamin B1","COVID-19 diagnosis 12/29/2020, pneumonia, CHF, depression, rheumatoid arthritis and anemia.","CHF, acute on chronic anemia, pulmonary hypertension, chronic pain, chronic kidney disease stage 3,",,lisinopril,['Death'],1,PFIZER\BIONTECH, 974177,MN,55.0,M,"ED visit for palpitations, fevers, chills with admission to the hospital for observation.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/25/2021,01/25/2021,0.0,PVT,atorvastatin (LIPITOR) 80 mg tablet Blood-Glucose Meter (RELION PRIME METER) CPAP dilTIAZem CD (CARDIZEM CD) 240 mg extended release 24 hr capsule diphenhydrAMINE (BENADRYL) 25 mg tablet durable medical equipment (DME) hydroCHLOROthiazide (,,DM (diabetes mellitus) (HC) Hyperlipidemia Sepsis due to group A Streptococcus (HC) Cellulitis of right lower extremity Hypotension Acute kidney injury (HC),,Adhesive Tape-Silicones,"['Chills', 'Palpitations', 'Pyrexia', 'SARS-CoV-2 test positive']",2,MODERNA,IM 974190,MI,51.0,F,"warmth in the chest; heart began to race and BP elevated. started to feel discomfort in chest and tightness in throat but did not close up. Was given Benadryl and Steiroid. chest x ray given which was normal. EKG taken which was abnormal but told was consistent with an older EKG. Was feeling better and about 90 minutes later felt warmth over my heart, my lips and mouth became tingly and both arms went numb and uncertain if my heart monitor showed abnormal. Was admitted overnight for observation. About 10 hours later had warmth in my chest, heart started beating fast, numbness in arms and around mouth and slight tightness in throat. Benadryl administered and heart calmed after couple of minutes, numbness went away after couple of minutes and tightness in throat went away after an hour. Again about 13 hours later the warmth in chest and heart racing only symptoms. Given another dose of Benadryl. The symptoms only lasted a couple of minutes. I also saw a cardiologist who ordered an echocardiogram just to rule out anything with my heart. It was normal. I was sent home with instructions to use Bendryl oral for 3 days every 12 hours. I was told it could be from vaccine and I was to follow symptoms for 2 weeks and if not better to see cardiologist to look at other reasons. I have taken the Benadryl for 3 days every 12 hours and did not have any other episodes with my heart. I am on day 6 now and I have joint pain and headache.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/21/2021,01/21/2021,0.0,PVT,cipro and lexipro,had beed at tail end of treatment for a UTI. Was on last 4 days of a two week antibiotic treatment,history of Crohn's disease although stable and not on any medications or treatments.,,"allergic to vicodin, iron infusions, sulfa drugs","['Arthralgia', 'Blood pressure increased', 'Blood test', 'Cardiac monitoring', 'Chest X-ray normal', 'Chest discomfort', 'Echocardiogram normal', 'Electrocardiogram abnormal', 'Feeling hot', 'Headache', 'Hypoaesthesia', 'Palpitations', 'Paraesthesia oral', 'Throat tightness']",2,PFIZER\BIONTECH, 974230,VT,92.0,M,"Patient had a fall at extended care facility, patient had worsening cognitive function. CT reveals subdural hematoma",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/18/2021,01/25/2021,7.0,SEN,"ASpirin 81mg, Symbicort, vitamin C, finasteride, synthroid, losartan, fish oil, multivitamin, tamsulosin, Spiriva, trazodone",,,,"Brimonidine, Prednisone","['Cognitive disorder', 'Computerised tomogram head abnormal', 'Fall', 'Subdural haematoma']",1,PFIZER\BIONTECH,IM 974244,CT,40.0,F,"PT shared that she had a history of allergic reaction to multiple antibiotics. PT denied that she had had an anaphylactic response and stated she did not carry an epi-pen. PT confirmed reading the fact sheet and review of the pre-vaccination questionnaire prior to coming to the clinic. At 5-10 min, RN checked with Patient. She stated she was feeling okay. She was reassured by RN that EMT staff were on site if she had any concerns. Pt stated ""Yes, I work at the police department. They are the reason I came here for the vaccine."" Within 20 min. of admin. she reported hives and itchy. Pt was imm. moved to the paramedic team, emergency care was initiated. Transfered to Hosp. ED",Not Reported,,Yes,Yes,,Not Reported,U,01/21/2021,01/21/2021,0.0,PUB,Denied,Reported she was feeling well,,,Multiple IV Antibiotics,"['Pruritus', 'Urticaria']",1,MODERNA,IM 974313,WI,54.0,F,"Patient vaccinated on 1/22. The next morning (1/23), patient experienced diminished sensory and motor function in left arm and leg, as well as facial numbness. Presented to the hospital on 1/24, and was found to have a small stroke in pontine medullary junction. Discharged on 1/25. There is some suspicion that her COVID infection in December may have precipitated this, and patient is currently being evaluated for coagulation disorders, primarily antiphospholipid antibody testing. It is unlikely that the vaccine contributed to this, but given close timeline between the two, filing this report.",Not Reported,,Not Reported,Yes,2.0,Yes,U,01/22/2021,01/24/2021,2.0,PVT,"Cholecalciferol daily, fish oil daily, garlic capsule daily, glucosamine daily, losartan daily, zinc daily, metformin 500 mg po daily (most doses are unclear from her medication history)",Patient was confirmed to be COVID positive in early December (did not require hospitalization).,"Hypertension, diabetes, morbid obesity",,None,"['Antiphospholipid antibodies', 'Brain stem infarction', 'Cerebrovascular accident', 'Coagulation test', 'Hypoaesthesia', 'Magnetic resonance imaging', 'Peripheral sensorimotor neuropathy']",1,MODERNA,IM 974341,FL,50.0,F,"Fever 104F and hallucinations prompting ED visit. While in CT, rigors observed which raised concern for seizure. Patient was admitted for workup. Subsequent EEG did not reveal epileptiform activity.",Not Reported,,Not Reported,Yes,3.0,Not Reported,,01/23/2021,01/24/2021,1.0,UNK,,,,,,"['Chills', 'Computerised tomogram abnormal', 'Electroencephalogram normal', 'Hallucination', 'Pyrexia']",2,MODERNA,IM 974345,TX,37.0,F,I received the immunization at 28w1d pregnant. I had an ultrasound at 28w that showed a healthy placenta. I had a repeat ultrasound at 29w1d that showed significant placenta issues. It has calcified and aged prematurely and also is heterogenous. I am currently inpatient in the hospital until delivery due to the rapid decline in placenta. EDD is 4/5/2021,Not Reported,,Not Reported,Yes,8.0,Not Reported,,01/14/2021,01/19/2021,5.0,PUB,"Labetalol, nifedipine, baby aspirin, prenatal, omeprazole",None,Hypertensive,,Triptan drugs,"['Exposure during pregnancy', 'Placental calcification', 'Placental disorder', 'Ultrasound antenatal screen abnormal']",1,MODERNA,IM 974358,CT,48.0,F,"on 12/30, I experienced a sudden onset of extreme dizziness. I proceeded to have one of the nurse techs I work with check my blood pressure in both arms. I was 198/103 and 190/100. A headache was starting, dizziness continued. They (NT) told me I didn't look good and my face was very red. I waited 15-20 minutes, sitting down and in a darken room, the NT checked again and BP was 168//100. So I called Nursing supervisor, who left it up to me to go home or ED. I choose ED. IN ED they did EKG (-), Cat scan (-), nuero checks often that were fine, labwork all fine. I was admitted because they wanted to follow up with an MRI in morning and continue nuero checks overnight. BP returned to normal when nighttime dose of Carvedilol was given along with and extra dose of HCTZ. Dizziness lessened but did not completely abate. Doctors recommended vestibular rehab. Pt doing PT 2x a week on going.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/24/2020,12/30/2020,6.0,WRK,"Carvedilol, Hydrochorthiazide, Metformin, Bijuva, Flexeril, Zyrtec, Famotidine","URI 11/28/20-12/8/20, Covid PCR swabs on 12/1, 12/6 both were negative.","HTN, IBS/GERD, Insulin resistance,",,"wheat, codeine, latex","['Computerised tomogram normal', 'Dizziness', 'Electrocardiogram normal', 'Erythema', 'General physical condition abnormal', 'Headache', 'Laboratory test normal', 'Magnetic resonance imaging normal', 'Neurological examination normal']",1,MODERNA,IM 974391,ND,83.0,F,"Patient has a long standing history of CHF and AFib, however, patient had a syncopal episode on 01/25/2021 in the morning. Per her hospital admission note, she stated that she felt fine, stood up, became dizzy and was able to lower herself to her chair then went unresponsive for a few minutes, but did regain consciousness. When she arrived to the emergency department, she was in atrial fibrillation with RVR with rate in the 140-150s. While the AFib is long standing, the RVR is new and potentially unexplainable. This was resolved with cardizem drip ending at 2220 on 01/25/2021. Alternatively, this patient is being put into VAERS as there are 2 other patients hospitalized with cardiac issues and received vaccine from the same pharmacy with the same lot number.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/20/2021,01/25/2021,5.0,PHM,"buspirone 10mg AM, buspirone 15mg PM, citalopram 20mg daily, loratadine 10mg daily, rosuvastatin 5mg daily, ferrous sulfate DR 324mg daily, losartan 100mg daily, multivitamin 1 tab daily, potassium chloride ER 10mEq oral daily, cholecalcif",unknown,"atrial fibrillation, heart failure, high cholesterol, hypertension. IBS, recurrent UTI, osteoarthritis, osteoporosis, scoliosis, depression, anxiety, hypothyroidism,",,NKA,"['Atrial fibrillation', 'Chest X-ray', 'Condition aggravated', 'Dizziness postural', 'Haematology test', 'Laboratory test', 'Syncope', 'Unresponsive to stimuli', 'Urine analysis']",2,PFIZER\BIONTECH,IM 974422,MD,85.0,F,Patient developed fever to 102 within 24 hours with decreased mentation. Stopped eating/drinking despite aggressively treating fever. Was DNR B status. Family agreed to a trial of IV fluids on 1/21 but was not successfully started until 1/22 after several attempts. Family wanted only comfort measures with no transfer to hospital. Patient continued to have fevers to 102-103 range. Patient passed on 1/23 . Patient did test positive for COVID in early September without significant illness. She was in usual state of health prior to vaccination.,Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/19/2021,1.0,SEN,"depakote, seroquel, aspirin, loratidine, prilosec, senna plus, vitamin D, gabapentin",none,"dementia with behaviors, GERD. H/o HTN and diabetes in past",,none,"['Death', 'Decreased appetite', 'Mental impairment', 'Pyrexia']",UNK,PFIZER\BIONTECH, 974424,WI,46.0,F,"Patient reported her tongue felt tingly 5 minutes following the first dose. She reported this finding at today's visit. She said she just took a Benadryl when she got home following her first dose. I did question if she has had anaphylaxis in the past to any meds, etc, and she said no, but reported having allergic symptoms with an antibiotic. No other allergic history to vaccines, meds, etc. Patient wanted to continue with second dose of vaccine today. Vaccinated at 1615. Patient reported tongue tingling at 1640. 25mg PO Benadryl given at 1640. Patient left the clinic at 1700 stating that she felt ok to leave. She had Benadryl at home and knew who to call if symptoms worsened. Writer called the patient back on 1/26/2021 at 1100. Patient stated that at 1900 last night (1/25/2021) she had to go to the Emergency room and received 2 doses of Epinephrine. She then had to stay the night to be observed. Patient stated that she was being discharged today.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/25/2021,01/25/2021,0.0,PVT,,,,,,['Paraesthesia oral'],2,PFIZER\BIONTECH,IM 974443,TN,76.0,M,"Patient received Moderna COVID vaccine on 12/30/2020 at a Pharmacy clinic where he was a resident. Nurses at the facility reported that he was responsive and showed no signs of any adverse effects until 1/2/2021 when he was observed slightly unresponsive and staring at the ceiling and trembling. He had a fever of 101F at this time. The facility ordered labs and a rapid COVID test (all of which came back normal) and started IV antibiotics. A few hours later, patient began bleeding from his eyes, nose, and mouth and was sent to the local ER. The patient refused being admitted to the ICU for possible sepsis/hemorrhage and died the following day on 1/3/2021. All healthcare professionals involved agreed that this was not likely due to the vaccine, but needed to be reported nonetheless.",Yes,01/03/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,SEN,Unknown,Unkown,Unknown,,,"['Death', 'Epistaxis', 'Eye haemorrhage', 'Full blood count normal', 'Metabolic function test normal', 'Mouth haemorrhage', 'Pyrexia', 'SARS-CoV-2 test negative', 'Staring', 'Tremor', 'Unresponsive to stimuli']",1,MODERNA,IM 974454,,78.0,F,Patient passed away 23 days after receiving COVID vaccine,Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/20/2021,23.0,UNK,,,,,,['Death'],1,MODERNA, 974464,MI,35.0,F,PRESENTING PROBLEM: Bilateral pulmonary embolism (HCC) HOSPITAL COURSE: 35-year-old female came in with shortness of breath and pleuritic chest pain who was found to have bilateral pulmonary embolism with moderately extensive clot burden. Her BNP and troponins were normal and no signs of right ventricular dysfunction on CT scan. Patient was placed on heparin drip and her symptoms improved. Ultrasound Doppler of bilateral lower extremities were negative. This was an unprovoked PE. Patient was switched to and discharged with Xarelto. She will benefit from a hypercoagulable workup once she is off of anticoagulation. After vaccine: patient reported difficulty breathing and fast heartrate,Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/19/2021,01/22/2021,3.0,OTH,"cholecalciferol, fluticasone, levonorgestrel, levothyroxine, rivaroxaban, sertraline",none,"hypothyroidism, depression",,"Amoxicillin, Clavulanic acid, nickel","['Brain natriuretic peptide normal', 'Computerised tomogram normal', 'Dyspnoea', 'Heart rate increased', 'Pleuritic pain', 'Pulmonary embolism', 'Troponin normal', 'Ultrasound Doppler normal']",1,PFIZER\BIONTECH,IM 974467,OH,58.0,M,Patient received both doses of COVID vaccine ( 1st dose 12/21/20 and 2nd dose 1/12/21). Patient was admitted to Medical Center on 1/24/21 and tested positive for COVID.,Not Reported,,Not Reported,Yes,,Not Reported,N,01/12/2021,01/24/2021,12.0,PVT,"Clozaril, Milk of Magnesia (PRN), ketoconazole cream, olanzapine, valproic acid, Bisacodyl, ondansetron, Ivenga IM, linezolid, pantoprazole, permethrin, Ativan",Unknown,"Lewy body dementia, schizophrenia, heart failure, diabetes, scabies. Was being treated for bacteremia.",,"fluphenazine, meloxicam, mesoridazine",['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 974471,LA,86.0,M,01/19/2021 patient received Moderna Vaccination. Later that evening patient began having abdominal pain. He took 2 tums and reported that he felt much better and slept well. On 01/20/2021 patient was seen by home health skilled nurse. All vital signs within normal limits with no complaints at skilled nurse visit. On 01/22/2021 patient participated in therapy with no complaints. Home Health notified today 01/26/2021 that patient was admitted to hospital on 01/22/2021 for abdominal pain.,Not Reported,,Not Reported,Yes,4.0,Not Reported,U,01/19/2021,01/22/2021,3.0,OTH,"Linzess, MegaRed Omega-3 Krill Oil, Levothyroxine, Losartan Potassium, Tamulosin HCl, Finasteride, Vitamin D3, Vitamin B12 TR, Aspirin, Sinemet, Sinemet CR, Amantadine Hcl","Parkinsons, Hypertension, Hypothyroidism, CVA","Chronic Constipation, CKD, Intertrigo, lower urinary tract symptoms, hip fracture",,"Penicillin, Sulfa antibiotics",['Abdominal pain'],UNK,MODERNA, 974489,MI,80.0,F,No immediate symptoms. No symptoms ever reported. Patient was found dead in her home on 1/25/2021 and last seen on 1/24/2021. Neighbor called for welfare check because they had not seen her and she had not checked mailbox. No evidence of foul play.,Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/25/2021,6.0,PVT,"Ipratropium and prednisone prescribed on 1/6/2021. Other medications include albuterol inhaler & nebulizer solution, calcium carbonate, cetirizine, cyclobenzaprine, fluticasone nasal spray, Advair HFA, home oxygen, guaifenesin, lidocaine 5","Asthma, COPD exacerbation.","Essential hypertension, dyslipidemia, allergic rhinitis, COPD, brain aneurysm, hiatal hernia, tobacco abuse, hyponatremia, normochromic, normocytic anemia, hx of MI, anxiety, intractable pain.",,"Clarithromycin, cefaclor, ciprofloxacin, codeine, erythromycin, penicillins, tramadol, naproxen. All of these cause shortness of breath. Generic lisinopril-HCTZ caused severe headache and nausea. Statins cause joint pain and stiffness, couldn't walk.",['Death'],1,PFIZER\BIONTECH,IM 974526,MN,82.0,M,"Unexplained dramatic drop in INR from 2.9 on January 11, 2021 to 1.3 on January 25, 2021. No symptoms experienced SQ Lovenox was initiated Follow-up INR is scheduled for January 27, 2021",Not Reported,,Yes,Not Reported,,Not Reported,U,01/21/2021,01/25/2021,4.0,PVT,"Carvedilol, Hydralazine, Bumex, Warfarin, Allopurinol, Amlodipine, Isosorbide, Multivitamin. Aspirin, Atorvastatin, Insulin",New Stroke 12/2021,"Congestive Heart Failure, COPD, diabetes- Type 2, ASHD, Aortic valve replacement, High Cholesterol, Chronic Renal Failure",,None,['International normalised ratio decreased'],1,PFIZER\BIONTECH,IM 974539,MA,39.0,F,"Patient had the second shot 1/12. Experienced numbness of feet within first 24 hrs. That continued up both legs and then weakness set in. Called PCP on the 15th as symptoms were getting worse not better. Patient advised me to go to ED. Went to ED here last Friday and was released. The weakness in legs got much worse and early the following week she started getting the numbness and weakness in arms. She went for the follow up post ED visit with NP at PCP office on 1/20 and due to the continued weakness, after consulting with one of the MDs, decision was made to send her back to ED for further work up to check for GBS including the LP in ED, labs and MRI of head, spine, lumbar and thoracic. Patient was release on Saturday 1/23 and diagnosis was a severe immune response to the vaccine. Patient still has unsteady gait and weakness.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/12/2021,01/13/2021,1.0,PVT,unk,,ASTHMA AND HYPERTENSION,,,"['Gait disturbance', 'Hypoaesthesia', 'Lumbar puncture', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging spinal', 'Magnetic resonance imaging thoracic', 'Muscular weakness']",2,PFIZER\BIONTECH,IM 974546,KS,61.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA I went to bed at 8 pm and noticed my arm was sore. I awoke at 11 pm to use the restroom and when I returned to bed I had a cough and SOB. This continued with copious secretions with worsening over time until I was fighting for air at 4:30 am. My husband called the ambulance because he did not feel he could get me to the hospital in time. In the ambulance I was started on 4L of O2. Upon arrival at the ER I was given a breathing treatment and started on the BiPap. I was admitted to the hospital and received 3 more breathing treatments and recovered to be on room air by 11:00 pm. The tests and observations, the doctor reported that there was no other cause than the vaccine.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/18/2021,01/18/2021,0.0,PVT,"Basaglar KwikPen U-100, carbidopa-levodopa 10-100 mg, sodium bicrbonate 650 mg, metoprolol succinate 100 mg , lisinopriL 10 mg, atorvastatin 40 mg, amLODIPine 10 mg, cloNIDine HCL 0.2 mg, isosorbide mononitrate 60 mg, ZurTeC 10 mg, Vitamin","IDDM, HTN, Stage 4 Kidney Disease","IDDM, HTN",,"Amoxicillin, Topamax, Biaxin, Invokana, Victoza, Sulfa","['Bilevel positive airway pressure', 'Cough', 'Dyspnoea', 'Increased bronchial secretion', 'Pain in extremity']",2,PFIZER\BIONTECH,SYR 974553,NY,66.0,F,"RESIDENT RECEIVED THE VACCINE ON 1/20/2021, RESIDENT HAD BEEN MONITORED EVERY SHIFT AND HAS NOT EXHIBITED ANY SYMPTOMS. RESIDENT WAS OBSERVED TO BE UNRESPONSIVE WITH NO PRESENCE OF VITAL SIGNS ON 1/24/2021. RESIDENT WAS A FULL CODE, CPR INITIATED UNSUCESSFULLY. BASED ON REVIEW WITH PRIMARY CARE PHYSICIAN AND MEDICAL DIRECTOR, THE RESIDENT HAD NOT HAVE ANY OTHER EVENTS PRIOR TO RECEIVING THE COVID VACCINE 4 DAYS PRIOR TO EVENT.",Yes,,Not Reported,Not Reported,,Not Reported,,01/20/2021,01/24/2021,4.0,SEN,"MOBIC, MVI, OLANZAPINE, REMERON, COLACE, TYLENOL",,"SCIZOPHRENIA, DEPRESSION, ANXIETY, HYPERKALEMIA",,NKA,"['Cardio-respiratory arrest', 'Death', 'Resuscitation', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 974573,MI,95.0,M,"ON 1/21/2020 RESIDENT WAS EXPERINCING CHILLS AND LOOSE STOOLS. FOLLOWING THIS EPISODE BECAME UNRESPONSIVE, PALE, DIAPHORETIC AND BRADYCARDIC. PALLIATIVE CARE WAS PROVIDED. RESIDENT PASSED AWAY APPROX. 10 HOURS LATER.",Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/21/2021,16.0,SEN,SYNTHROID 25MCG DAILY PRILOSEC 10MG DAILY CASODEX 50MG DAILY TYLENOL 500MG THREE TIMES DAILY MULTIVITAMIN DAILY ZOLOFT 25MG DAILY NAPROXEN 440MG DAILY,URINARY TRACT INFECTION,HYPERTENSION DEMENTIA INTERSTITAL PULMONARY DISEASE GERD HYPOTHYROIDISM PAIN HYPERLIPIDEMIA MALIGNANT NEOPLASM OF PROSTATE OSTEOARTHRITIS CONSTIPATION WEAKNESS UTI PERIPHERAL VASCULAR DISEASE,,STATINS,"['Bradycardia', 'Chills', 'Death', 'Diarrhoea', 'Hyperhidrosis', 'Pallor', 'Unresponsive to stimuli']",1,MODERNA,IM 974577,WV,,U,"shingles; ill defined disorder; This spontaneous report as received from a lawyer refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On or about 03-OCT-2012, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) for prophylaxis (dose, route, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequent, on unknown date, after zoster vaccine live(ZOSTAVAX) inoculation, the pt was treated by healthcare providers, including the physiciaN for shingles, and other zoster-related conditions. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.",Not Reported,,Not Reported,Yes,,Not Reported,N,10/03/2012,,,PHM,,,,,,"['Herpes zoster', 'Ill-defined disorder']",UNK,MERCK & CO. INC., 974639,,,F,"reaction as a child to the pertussis part of the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) vaccine which resulted in convulsions; Initial information was received on 18-Dec-2020 regarding an unsolicited valid serious courtesy case from a consumer/non-hcp (healthcare professional) via Pfizer Inc. This case involves a female patient (also reported as a baby) who had a reaction as a child to the pertussis part of the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) which resulted in convulsions, while she received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DTAP]. Medical treatments, vaccinations and concomitant medication were not provided. At the time of the event, the patient had ongoing medical history of latex allergy (rubber sensitivity) which was hereditary and she was tested for this before childbirth. She has concerns about her son receiving as well. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer, batch number and expiration date was not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient had a reaction as a child to the pertussis part of the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) which resulted in convulsions (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant. The reporter wanted to know about the ingredients in the PFIZER-BIOTECH Coronavirus disease (COVID-19) VACCINE. It was not reported if the patient received any corrective treatment or not. The outcome of the event was unknown at the time of reporting. Information on the batch number has been requested for this case.; Sender's Comments: This case concerns a baby female patient who experienced seizure after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE from unknown manufacturer. The time to onset is unknown. The patient has the history of latex allergy. The patient's medical condition at time of vaccination, concomitant medication and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,Latex allergy (this allergy is hereditary and was tested before childbirth),,,,['Seizure'],UNK,UNKNOWN MANUFACTURER,OT 974692,FL,,U,"other zoster-related conditions; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 01-JAN-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively, on or about 01-JAN-2011, the patient's pharmacist relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine and believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequent to the vaccination, the patient was treated for shingles and other zoster-related conditions. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles and ill-defined disorder were not recovered. The reporter considered shingles and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX).",Not Reported,,Not Reported,Yes,,Not Reported,N,01/01/2011,,,PHM,,,,,,['Herpes zoster'],UNK,MERCK & CO. INC.,OT 974794,NE,89.0,F,"Patient presented to Vaccine clinic 1/12/21 to receive COVID vaccination. Patient denied any ill feeling, no fever, cleared for vaccination. Is chronically SOB due to COPD, but patient reported no different than usual. Presented to the ED the next day c/o SOB and weakness for the last week. Patients condition ultimately declined over the next few days and died 01/21/21 from pneumonia (not COVID). Patient did admit she lied about her symptoms on the day of vaccination to get the shot.",Yes,01/21/2021,Not Reported,Yes,8.0,Not Reported,N,01/12/2021,01/21/2021,9.0,PVT,"albuterol, amlopidine, aspirin, atorvastatin, lasix, gabapentin, HCTZ, hydroxyzine, lansoprazole, levalbuterol, losartan, meloxicam, Norco, Nystatin, Preservision, Prolia, Refresh eye drops, Spiriva, Wixela","Pneumonia, pleural effusion, COPD,","macular degeneration, hyponatremia, osteoporosis, anemia, hx of breast cancer, GERD, hyperlipidemia, OSA, ex-smoker",,"Sulfa, duloxetine","['Asthenia', 'Bacterial test positive', 'Blood albumin decreased', 'Blood alkaline phosphatase increased', 'Blood creatinine increased', 'Blood potassium normal', 'Blood sodium decreased', 'C-reactive protein increased', 'Death', 'Dyspnoea', 'Haemoglobin decreased', 'Platelet count increased', 'Pneumonia', 'Procalcitonin increased', 'Sputum culture', 'Staphylococcus test negative', 'Troponin normal', 'White blood cell count increased']",1,MODERNA,SYR 974825,TN,44.0,M,5 minutes after receiving vaccine I started feeling ?heavy ?. This progressed until I was diagnosed with Covid pneumonia and hospitalized on 1/17/21. I must have had asymptomatic case of Covid that was escalated by vaccine.,Not Reported,,Not Reported,Yes,4.0,Not Reported,U,01/07/2021,01/07/2021,0.0,PUB,None,None,None,,"PCN, sulfa drugs","['COVID-19 pneumonia', 'Discomfort']",1,MODERNA,SYR 974832,MA,22.0,F,"first dose of moderna vaccine (1/13 on L arm), admitted 1/24/2021 with progressive fever sore throat and odynophagia found to have RIJ lymphadenitis. Now persistently febrile, hypotensive, tachycardic",Not Reported,,Not Reported,Yes,,Not Reported,N,01/13/2021,01/23/2021,10.0,PVT,OCPs,COVID -19,None,,"Milk, peanuts, amoxicillin","['Hypotension', 'Lymphadenitis', 'Odynophagia', 'Oropharyngeal pain', 'Pyrexia', 'Tachycardia']",1,MODERNA,IM 974833,ND,85.0,M,"1/24/21 0445- patient presents to the ED with complaints of neck pain, chest pain, and back pain for about a week. States also feels SOB, intermittent fever with temperature 100.3 on arrival. Patient was worked up for his cardiac type symptoms, found to have elevated WBC and CRP with no explanation. D-Dimer was elevated with CT showing no sign of PE. Patient was sent home from the ED with instructions to follow up with primary care and/or return if s/s worsen. 1/24/21 1705- patient is returned to the ED via ambulance after becoming unresponsive and some seizure like activity. Patient was intubated. Head CT showed large brain bleed that was irreparable and not compatible with life. Patient was also found with positive blood cultures x2 with gram positive cocci in clusters growing after 9 hours.",Yes,01/25/2021,Not Reported,Yes,1.0,Not Reported,N,01/19/2021,01/24/2021,5.0,PVT,"isosorbide mononitrate ER 30mg daily, allopurinol 300mg daily, aspirin 81mg daily, nitroglycerin 0.4mg PRN, rosuvastatin 10mg daily, codine/guaifenesin syrup 5lm PO Q6H PRN, fursemide 40mg BID, levothyroxine 75mg daily, metoprolol succinate",unknown,"CHF, heart murmur, hyperlipidemia, hypertension, aortic valve leak, acute renal failure, history of CABG, AICD and heart stent placement",,NKA,"['Back pain', 'Blood culture positive', 'C-reactive protein increased', 'Cerebral haemorrhage', 'Chest X-ray', 'Chest pain', 'Coagulation test', 'Computerised tomogram head abnormal', 'Computerised tomogram thorax normal', 'Dyspnoea', 'Endotracheal intubation', 'Fibrin D dimer increased', 'Gram stain positive', 'Haematology test', 'Laboratory test', 'Neck pain', 'Pyrexia', 'Seizure like phenomena', 'Unresponsive to stimuli', 'Urine analysis', 'White blood cell count increased']",1,MODERNA,IM 974847,CA,63.0,M,"left sudden sensorineural hearing loss , ear numbness. symptoms began 48 hours after vaccination. Treatment began 3 days after onset of symptoms and included high dose prednisone and trans-tympanic dexamethasone shots. The patient partially recovered after 3 weeks of treatment.",Not Reported,,Not Reported,Not Reported,,Yes,Y,12/25/2020,12/27/2020,2.0,PVT,"CoQ10, B12, fish oil",none,none,,none,"['Deafness neurosensory', 'Full blood count normal', 'Hypoaesthesia', 'Laboratory test normal', 'Magnetic resonance imaging normal', 'Metabolic function test', 'Metabolic function test normal', 'Thyroid function test normal']",1,PFIZER\BIONTECH,IM 974848,WA,60.0,F,"Woke up the next morning with slurred speech, right side weakness, illegible writing, balance issues. Next day all symptoms worse. Went to Urgent Care, was transferred to Hospital. Diagnosed with stroke.",Not Reported,,Not Reported,Yes,2.0,Yes,N,12/29/2020,12/30/2020,1.0,PVT,"Hydochlorothiazide 25 mg daily, Losartan 25 mg daily, Meloxicam 7.5 mg daily, Fexofenadine 180 mg daily, Omeprazole 40 mg daily, ALIVE womens vitamins daily, Citralcal maximum daily, Triple Flex 50+ daily, Probiotic daily.",None,Hypertention,,None,"['Balance disorder', 'Cerebrovascular accident', 'Computerised tomogram', 'Dysarthria', 'Dysgraphia', 'Hemiparesis', 'Laboratory test', 'Magnetic resonance imaging', 'Neurological examination', 'X-ray']",1,MODERNA,IM 974855,MA,76.0,F,"decedent had shortness of breath and hypoxia, cardiac arrested in front of the EMS crew, ACLS initiated, arrived in the Hospital ED asystole and pronounced dead",Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,SEN,"pantoprazole, levothyroxine, lisinopril, lamotrigine, atenolol, mirtazapine, furosemide, dronabinol","hypothyroid, hypertension",same,,No Known Allergies,"['Cardiac arrest', 'Death', 'Dyspnoea', 'Hypoxia']",1,PFIZER\BIONTECH,IM 974892,NY,82.0,F,"Presented to ED with complaints of Fever, chills, and myalgia. Symptoms transitioned into lethargy and weakness. Treatments: Physical Therapy for strengthening, lab work, fever reducing medications!",Not Reported,,Not Reported,Yes,7.0,Not Reported,Y,01/16/2021,01/17/2021,1.0,PHM,"Amlodipine, Celebrex, glucosamine, Hydrochlorothiazide, losartan potassium, hydrocodone, omeprazole, oyster shell vitamin d.",Positive COVID-19 Test on 1/4/2021.,"HTN, GERD, DJD, chronic arthralgias, osteoarthritis.",,"Morphine, NKFA","['Asthenia', 'Chills', 'Laboratory test', 'Lethargy', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 974897,NJ,52.0,F,"Per patient report: Patient works in hospital setting and states that she began feeling numbness of left face at about 1130 on 01/06/2021. Patient walked to ED and while walking, began to have numbness of left arm and leg as well. Patient reports being given Valtrex. Patient was discharged from hospital on 01/07/2021. Patient is being followed by her private provider as well as neuro.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/28/2020,01/06/2021,9.0,PVT,Furosemide 20 mg daily Atorvastatin 10 mg po daily,NOne,"hx of malignant neoplasm of colon, hypertension, elevated lipids",,NKDA,['Hypoaesthesia'],1,MODERNA,IM 974960,MI,53.0,M,ON 1/14/2021 TYPICAL UTI SYMPTOMS FOR RESIDENT DEVELOPED INCLUDING FEVER AND RIGIDITY. RESIDENT IS NON-VERBAL. IV ANTIBIOTICS WERE STARTED. FREQUENT UTI'S ARE COMMON FOR THIS RESIDENT.,Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/14/2021,9.0,SEN,"JEVITY, FAMOTIDINE, VALIUM, ATROPINE, LABETALOL, PROSCAR, LASIX, DUONEB, KEPPRA, GUIAFENESIN, ERYTHROMYCIN ETHYLSUCCINATE",UTI,"TRAUMATIC BRAIN INJURY, VEGETATIVE STATE, HYPERTENSION, HEART FAILURE, POST TRAUMATIC SEIZURES, CHRONIC RESPIRATORY FAILURE, FLACCID HEMIPLEGIA, GASTROPARESIS, APHASIA",,AMOXIL,"['Condition aggravated', 'Culture urine', 'Full blood count', 'Muscle rigidity', 'Pyrexia', 'Urinary tract infection', 'Urine analysis']",1,MODERNA,IM 974998,ND,79.0,F,patient presented to her primary care for evaluation of leg pain. Noted on US that patient had a DVT in Left distal superficial femoral and popliteal veins. patient was hospitalized for treatment as patient had recent diagnosis of GI bleed and would need close monitoring of blood thinning medications. Of note- patient is 1/3 hospitalized with cardiac/blood issues currently in this facility who received a vaccine from this pharmacy in the last month and all three patients have the same COVID vaccine lot number. Physician elected to have a VAERS put in on all patients to ensure investigation was properly handled.,Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/20/2021,01/22/2021,2.0,PHM,"levothyroxine 88mcg daily, benzonatate 100mg PO QID PRN, betamethasone valerate 1% cream topical Daily PRN, ducosate sodium 100mg BID, ketotifen 0.025% opthl soln 1 drop both eyes BID PRN, multivitamin 1 tab PO Daily, pantoprazole sodium 40","Diagnosed with COVID 12/16/2020, hospitalized at our facility 12/16/2020- 12/31/2020. Patient then went to Bismarck, ND for GI bleed. unsure of discharge date.","hypertension, urinary incontinence, osteoarthritis, hypothyroidism, BMI +30",,"levofloxacin, adhesive, iodine/iodide containing products, penicillins","['Chest X-ray', 'Coagulation test', 'Deep vein thrombosis', 'Haematology test', 'Laboratory test', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 975002,WI,88.0,M,"on 1/13/2021 at 3:40am Cliff called for assistance. He lost his balance and had fallen. Cliff refused vitals, refused emergency department, denied hitting his head. As the day progressed patient developed a headache, diarrhea, and vomiting. He again declined the offer for the emergency room. At supper time wife and staff found Cliff unresponsive, 911 was called and he was taken to the emergency department. The ER did a CT scan and found an acute subdural hematoma. Patient was placed on comfort cares and expired at 3pm on 01/14/2021. Cliff did not have a history of falls.",Yes,01/14/2021,Not Reported,Yes,1.0,Not Reported,N,01/12/2021,01/13/2021,1.0,SEN,"Cholecalciferol 1000 ius daily, Magnesium Oxide 400mg BID, Vi",Stable,"Chronic atrial fibrillation (on warfarin), coronary artery disease, chronic heart failure with preserved ejection","Influenza vaccine 10/06/2020, age 88, fever, chills, vomiting, malaise","Bee venum, shellfish, adhesive tape, cardizem, primidone","['Balance disorder', 'Computerised tomogram head abnormal', 'Death', 'Diarrhoea', 'Fall', 'Headache', 'Subdural haematoma', 'Unresponsive to stimuli', 'Vomiting']",1,MODERNA,SYR 975020,NY,73.0,F,"Had normal side effects the day after, 12/25/20 slight fever, lethargy, not even sore arm. on the 27th, felt fine. On 12/28/20, woke up not able to breath, oxygen saturation 83%, could not walk across the room without gasping for air, which lasted for about 2 days. Could not reach her PCP due to holidays, was convinced she had COVID. Went to drive-thru facility and got the COVID test on 12/28/20, negative on 12/29/20. Then made another APT, went back on 12/30/20 had negative test again. On 12/30/20 started feeling better, was not great but her 02 SAT's were about 90. Stayed that way until 1/8/21, had FU from lumpectomy with surgeon, when she got up her left ankle/foot were very swollen and red looking. Saw that Dr., and discussed the postop business and showed her the foot/leg told her to have it looked at. Her PCP was closed, she went to radiology Dept in Hospital and found DVT in her left leg. She was then told to go to the ER and ordered a CT scan, which showed pulmonary emboli in both lungs. Put on heparin IV right away, later transferred to another hospital where CV surgeon on staff. By that evening they decided that she was walking , talking and checking blood levels, kept her overnight and sent her home the next day. Needed to be on blood thinners, and saw pulmonologist. Has APT with hematologist this week. Pulm told her to call and report adverse reaction. Today, 1/26/21 her 02 SAT's are in the 99%, leg is still swollen, and is able to breath better. On Eliquis which will prevent new clots, but the others should be absorbed. Got 2nd dose on 1/21/21 and had only the classic side-effects for about 30 hours but was then fine. Had fever, chills, nausea, sore arm, cough, but then was fine. Same lot # as dose 2.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/24/2020,12/28/2020,4.0,PVT,"Losartan, Vitamin D.",Had lumpectomy on 11/17/20 that showed precancerous pathology report.,"High blood pressure, family history of Alpha1 anti-tripsin deficiency. She has single alliel form. Over time she gets short of breath, can go 2 flights of steps but not 3. Can play tennis but not doubles.",,None.,"['Chills', 'Computerised tomogram thorax abnormal', 'Cough', 'Deep vein thrombosis', 'Dyspnoea', 'Erythema', 'Joint swelling', 'Lethargy', 'Pain in extremity', 'Peripheral swelling', 'Pulmonary embolism', 'Pyrexia', 'SARS-CoV-2 antibody test negative', 'SARS-CoV-2 test negative', 'Ultrasound Doppler abnormal']",1,MODERNA,IM 975023,NY,76.0,M,"CARDIAC ARREST THAT LEAD TO DEATH - IT WAS REPORTED BY EMS THAT THE PT HAD RECEIVED THE VACCINE ABOUT 30 MINS PRIOR. HE ARRIVED HOME, BECAME SHORT OF BREATH & COLLAPSED. 911 WAS CALLED AND HE WAS TRANSPORTED VIA EMS TO HOSPITAL (16:17) WHERE HE LATER EXPIRED (23:01).",Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,PVT,"ATORVASTATIN 20MG DAILY, GABAPENTIN 300MG TWICE DAILY, HYDRALAZINE 10MG 3 TIMES DAILY, LANTUS 30UNITS AT BEDTIME, LUMIGAN OPHTHALMIC SOLN BOTH EYES EVERY EVENING, METOLAZONE 2.5MG DAILY, OMPERAZOLE 20MG DAILY, PREDNISONE 15MG DAILY, TORSEMI",,"PULMONARY FIBROSIS, HYPERTENSION, DIABETES MELLITUS, COPD, TOBACCO USE, ALCOHOL INTAKE, RESPIRATORY FAILURE, PVD, PROTEINURIA, PERICARDITIS, HYPERLIPIDEMIA, OBESITY, ILD, HYPONATREMIA, CKD STAGE 3, BPH, ANEMIA, BILATERAL HEARING LOSS, GERD, HYPERSENSITIVITY PNEUMONITIS, DIASTOLIC CONGESTIVE HEART FAILURE, SOLITARY PULMONARY NODULE",,"SULFA, IODINE-BASED CONTRAST MEDIA","['Cardiac arrest', 'Death', 'Dyspnoea', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Respiratory syncytial virus test negative', 'SARS-CoV-2 test negative', 'Syncope']",1,MODERNA,IM 975057,CA,70.0,M,"*Atrial fibrillation . No prior instances.* Vaccine 1/20/2021. On 1/21, 25 hours after vaccine felt slight pressure in chest and rapid heat beat. Heart rate 150. EKG in Cardiologist's office. Admitted to hospital On 1/22/2021 -- DC (Direct Current) Cardioversion Procedure Prior to the procedure, a transesophageal echocardiogram was performed which showed no evidence of left atrial appendage thrombus. The patient was successfully cardioverted on the 1st attempt after administration of 150 joules using a bi-phasic defibrillator. A post cardioversion EKG was obtained and reviewed. The patient tolerated the procedure well with no complications. Post-procedure vitals: HR 65 BP 119/71 O2 sat 99%",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/21/2021,01/22/2021,1.0,SEN,Finasteride 5 mg oral tablet- Brand Name: PROSCAR 1 tablet daily. Terazosin 5 mg capsule- Brand Name: HYTRIN. 1 capsules 2 times daily. Rosuvastatin 10 mg oral tablet- Brand Name: CRESTOR 1 tablet daily. Aspirin 81 mg oral tablet 1 tab,,"Essential HYpertension, GERD, LVH,",,Erythromycin; Cefaclor; Scopolamine Tramadol,"['Atrial fibrillation', 'Cardioversion', 'Chest discomfort', 'Echocardiogram', 'Electrocardiogram', 'Heart rate increased']",1,MODERNA, 975065,MA,51.0,F,"Dizzyness Flushed face and neck Swollen tongue Minor facial swelling around eyes Epi Pen and 50mg of Benedryl, bp remained normal, patient remained fully conscious. 911 called and transport to Emergency Dept",Not Reported,,Yes,Not Reported,,Not Reported,,01/22/2021,01/22/2021,0.0,WRK,,,,,,"['Dizziness', 'Flushing', 'Periorbital swelling', 'Swollen tongue']",1,MODERNA,IM 975111,OR,30.0,F,"Around 8pm on the day I was given the vaccine, my heart began to race and lasted for about 1 minute. I was able to breathe deeply and eventually my heart rate slowed down. I had 2 more episodes the next morning. Around 9am. Again I was able to breathe through them. I received the vaccine when I was 18 weeks, 4 days pregnant. I called my OBGYN's office and was told to monitor and register my reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,PHM,"Gummy multi-vitamin, unisom 50mg gel cap",,"asthma, depression",,sulfa,"['Exposure during pregnancy', 'Palpitations']",1,PFIZER\BIONTECH,SYR 975118,LA,68.0,F,"Right arm sore, red, hard. Around 1:00 a.m. I became very nauseous. Chills began and lasted through night. Upon awaking light headed, arm worse but nausea had stopped. My taste was funny like when I had Covid. No appetite. Chills came back during morning. Fever 101. Fatigued went to bed. Slept all afternoon. Still no appetite. Cough returned as when had Covid. Fever no higher. Went to bed woke up fine. Lasted 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/24/2021,01/25/2021,1.0,PHM,"Vitamins D, C and zinc. Atorvastatin 20 mg daily. Tirosint 112 mg daily",10 weeks post Covid,One kidney,,None,"['Chills', 'Cough', 'Decreased appetite', 'Dizziness', 'Erythema', 'Fatigue', 'Induration', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Taste disorder']",1,MODERNA,SYR 975119,MS,42.0,F,"I got the vaccine on Tues felt fine later that evening arm was sore couldn't sleep on (right side). I went work on Wed arm felt as if had fever. I informed employee health was told the symptoms was common. I took Ibuprofen before laying down Wed my throat felt as if closing up. Upon me calling my mom voice was screeching . My mom asked my sister to bring me some Benadryl. I contacted the director of employee health was informed to go ER. Then my lips was swelling, Oxygen was fine and I was given Pepcid.I stayed overnight for observation.",Not Reported,,Not Reported,Yes,,Not Reported,,12/22/2020,12/23/2020,1.0,PVT,"Norvac, Hydrochloride, Birth Control, Lexapro,Alive,Icarsee,",No,"Anemia,Blood pressure",,Albecton,"['Dysphonia', 'Lip swelling', 'Pain in extremity', 'SARS-CoV-2 antibody test negative', 'Skin warm', 'Sleep disorder', 'Throat tightness']",1,MODERNA,IM 975148,IL,59.0,M,"On 1/4/21 Client had what appeared to be a seizure and went unresponsive. He foamed from the mouth and turned blue. O2 Sat was in the 60's, O2 was applied previous to paramedics arrival. BP was high. Unresponsive for 30 minutes. When he woke he did not recognize anyone, did not know where he was at or what day of the week it was. He was transported to the Hospital. Multiple tests were ran and nothing out of the ordinary was found. Started seizure medication.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/02/2021,01/04/2021,2.0,SEN,lisperol/diaretic,none,high blood pressure,,penicillin,"['Blood test normal', 'Cyanosis', 'Disorientation', 'Foaming at mouth', 'Hypertension', 'Magnetic resonance imaging normal', 'Oxygen saturation decreased', 'Seizure', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,SYR 975152,NJ,73.0,F,"Three hours after the vaccination, my heart started beating very rapidly. I went to the Urgent Center and my heart rate was 161 and my blood pressure 174/113. When they gave me an EKG, I was in aFib. I was sent by ambulance to Hospital where another EKG, an xRay and some blood tests were taken. I was kept overnight and released the next afternoon after my blood pressure and heart rate was lower.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/22/2021,01/22/2021,0.0,OTH,"Losartan, Xyzal, Advair, Singilair, Flonase, Astelin, Gabapentin, Multivitamin, Vitamin D, Elderberry",no illnesses,"High Blood Pressure, Asthma, Sleep Apnea, Lymphedema",,None,"['Activated partial thromboplastin time', 'Atrial fibrillation', 'Blood thyroid stimulating hormone', 'Differential white blood cell count', 'Electrocardiogram abnormal', 'Full blood count', 'Heart rate increased', 'Hypertension', 'International normalised ratio', 'Metabolic function test', 'Prothrombin time', 'Troponin T', 'X-ray']",UNK,PFIZER\BIONTECH, 975178,FL,66.0,M,Patient received the vaccine on 12/21/2020 and shortly after began having headaches associated with decreased coordination and ataxia. Patient had an MRI performed at another facility which showed bilateral subdural hematomas and midline shift. Patient was operated on at another facility for evacuation of subdural hematomas. Post-op hospital course for unremarkable. Patient underwent physical therapy and rehabilitation at Doctors Memorial and discharged on 01/25/2021.,Not Reported,,Not Reported,Yes,17.0,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,Gabapentin 600mg three times a day Glycopyrrolate 1mg three times a day as needed Tamsulosin 0.4mg at bedtime Primidone 50mg Propranolol 160mg extended release,No known illnesses,Hypertension COPD Benign Essential Tremors,,No known allergies,"['Ataxia', 'Brain midline shift', 'Coordination abnormal', 'Headache', 'Magnetic resonance imaging brain abnormal', 'Subdural haematoma', 'Subdural haematoma evacuation']",1,MODERNA,IM 975184,AR,89.0,F,The patient had a heart attack and died at a local hospital morning of 1/19/2021.,Yes,01/19/2021,Not Reported,Yes,,Not Reported,N,01/14/2021,01/19/2021,5.0,PHM,Unknown,none,Heart disease Mild stroke about a year ago,,none,"['Death', 'Myocardial infarction']",1,PFIZER\BIONTECH,IM 975206,OH,87.0,F,"1 fall after first dose on 1/8/2021 at 1930; no injuries; 4 falls after second dose on 1/14/21 at 1545, 1/15/21 at 1700, 1/21/21/at 1220 and 1/21/21 at 1330 all falls with no injuries. Started Ceftriaxone 1 GM IM daily for 5 dyas on 1/21/21 for UTI: E. Coli",Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/22/2021,31.0,SEN,"Aricept 10 mg at bedtime; Cerovite Sr, Tablet 1 tablet daily; Coreg 6.25 mg two times a day; Ferrous Sulfate 325 mg two times a day; Folidc Acid 1 mg daily; Lexapro 5 mg daily; Lisinopril Hydrochlorothizide 20-12.5 mg daily; Methimazole 5 m",11/30/2020 positive for Covid-19,"Alzheimer's Dementio; Esential hypertension; major depressive disorder, recurrent; osteoarthritis bilateral knees; Hyperlipidemia; specified diorders of thyroid; Vit D deficiency; Impulse control disorder; Unspecified dementia with behavioral disturbance; Hypertensive retinopathy; unspecified abnormalities of gait and mobility; feeding difficulties; other dysphagia.",,No known allergies,"['Chest X-ray normal', 'Culture urine positive', 'Escherichia infection', 'Fall', 'Full blood count normal', 'Metabolic function test normal', 'Urinary tract infection']",2,PFIZER\BIONTECH,IM 975214,NC,86.0,M,He had a stroke later that night after receiving vaccine.,Not Reported,,Yes,Yes,5.0,Yes,N,01/22/2020,01/22/2021,366.0,MIL,,Na,Heart attack 2 years ago. High blood pressure and borderline diabetic. He had a stroke friday night. Same day as vaccine,,Na,['Cerebrovascular accident'],1,PFIZER\BIONTECH, 975223,TX,105.0,F,"Systemic: Headache-Severe, Systemic: Other- Death 8 days after receiving the vaccine-Severe",Yes,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,SEN,,,,,Azithromycin and Sulfa antibiotics,"['Death', 'Headache']",1,PFIZER\BIONTECH,IM 975228,VA,45.0,M,"The patient did not have any adverse reactions during the 15 minute observation, nor any reported the day of the vaccine. Between his COVID diagnosis and the second vaccine, he had serval documented complaints of nausea, dizziness, body aches. The patient had a virtual visit on 1/21/2021 for dizziness, nausea and fever. At this time, these symptoms had been persistent for one month according to his medical records. Patient later presented to the Urgent Care for with a fever of 103.1, rigors, nausea and cough. Patient admitted to hospital for sepsis.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/20/2021,01/21/2021,1.0,PVT,"Zofran, Vistaril,","Patient diagnosed with COVID on 12/30/2020. Since diagnosis, up until second vaccine on 1/20/2021, patient had c/o dizziness, body aches, fever, and ringing in the ears. Patient seen in Urgent Care on 12/30/ 2020 for vomiting, dehydration, dx with bacterial coinfection. First COVID Vaccine administered on 12/ 23/2020. No reaction to initial vaccine.","DM 2, hyperlipidemia, gastroparesis, neoplastic neuroma, insomnia",,NKDA,"['Chills', 'Cough', 'Dizziness', 'Nausea', 'Pyrexia', 'Sepsis']",2,MODERNA,IM 975246,FL,84.0,M,"~2 weeks after 1st dose, patient suffered cerebral hemorrhage. Was also on Eliquis. Received KCentra.",Not Reported,,Yes,Yes,8.0,Yes,N,01/07/2021,01/19/2021,12.0,UNK,"Gabapentin, tamulosin, atorvastatin, isosorbide, KCl, shingrix (4/23/20), twinrx (4/23/20), synthroid, omeprazole, eliquis",,"CKD, DM, hyperlipidemia, afib",,NKMA,['Cerebral haemorrhage'],1,PFIZER\BIONTECH,IM 975268,FL,71.0,F,"Client received vaccine in drive thru clinic operation, while in observational area, EMS was on site, 10 minutes after vaccine was administered, pt experienced anaphylactic reaction including swelling of lips, tongue, and throat, 0.3mg epi , 125 mg solucortef, 50mg Benadryl administered by EMS. Pt transferred to local ER. Presented to ER with no swelling noted, breathing unlabored, skin w/d/intact.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/12/2021,0.0,OTH,unknown,no,unknown,,"pt consent form states ""yes"" to Do you carry an Epi Pen for emergency treatment of anaphylaxis and or have allergies or reaction to any medications foods , vaccines, or latex? no further info is recorded.","['Anaphylactic reaction', 'Lip swelling', 'Pharyngeal swelling', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 975318,KY,62.0,F,"PATIENT RECIEVED 2ND DOSE OF SHINGRIX VACCINE AROUND 9:30 AM ON 1/22/2021, RECEIVED NOTIFICATION PATIENT SUFFERED FATAL HEART ATTACK MORNING OF 1/23/2021.",Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/23/2021,1.0,PHM,"RX: ALPRAZOLAM 0.5MG, TRAZODONE 100MG, TIZANIDINE 2MG, OXYBUTYNIN ER 10MG, LINZESS 290MCG, LEVOTHYROXINE 175MCG, OXYCODONE-ACETAMINOPHEN 7.5MG/325MG, GABAPENTIN 800MG, ALBUTEROL HFA 90MCG, METFORMIN 500MG",UNKNOWN,"DIABETES, HEART DISEASE, ARTHRITIS, DEPRESSION, HYPOTHYROIDISM, PAIN",,NKDA,"['Death', 'Myocardial infarction']",2,GLAXOSMITHKLINE BIOLOGICALS,IM 975322,,42.0,M,"diffuse rash appearing to be urticaria. fever, chills",Not Reported,,Not Reported,Yes,,Not Reported,N,01/05/2021,01/11/2021,6.0,UNK,,,,,,"['Chills', 'Pyrexia', 'Rash', 'Urticaria']",1,MODERNA,IM 975341,FL,56.0,F,"Approximately 20 minutes after receiving the vaccine she stood up to leave the vaccine clinic. She said she felt like she was having palpitations. She denied chest pain and shortness of breath. She was placed cardiac monitor showing a rapid Atrial Fibrillation. VS were - 5:25 pm 137/97, HR 133 - 140, R 18, O2sat 98% 5:30pm 145/107, HR 141, R 15, O2sat 98% 5:40pm 117/101, HR 128, R 15, O2sat 98% 5:46pm 152/109, HR 146, R 16, O2sat 98% - Sent to Emergency Department with ED staff after Code Green was called. She remained awake, alert, and oriented x3 throughout.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/25/2021,01/25/2021,0.0,PVT,"Klonopin, Metoprolol, Requip",None,"Hypertension, Seizures, Mitral Valve Prolapse, Restless Legs",,NKA,"['Atrial fibrillation', 'Blood test', 'Cardiac monitoring abnormal', 'Electrocardiogram', 'Palpitations']",2,MODERNA,IM 975382,FL,83.0,M,"01/22/20When transferring resident from bed to W/C Resident became unresponsive to voice with eyes fix open and point up to the right. Placed resident back in bed found 82% o2 sats B/P 110/106 pulse 110 resp below 16 placed o2 via non rebreather with 20 l/min 02 up to 90% then stabilized at 89% Resident following all commands encouraged to take do breathing exercises, with some compliance, continues ABT/pneumonia , no s/s adverse 1/23/2021 16:48 Discharge Summary Note Text: Resident found unresponsive with no pulse or respirations in bed with emesis on gown. Time of death verified at 1645 with LPN. Funeral Home called at 1900 and body released at 2000.",Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/22/2021,2.0,SEN,Acetaminophen Tablet 325 MG Give 2 tablet by mouth every 4 hou,"Anemia, Dementia, COPD","Anemia, Dementia, COPD",,none,"['Blood urea increased', 'Brain natriuretic peptide increased', 'Chest X-ray abnormal', 'Death', 'Eye movement disorder', 'Lung opacity', 'Pneumonia', 'Pulse absent', 'Respiratory arrest', 'Staring', 'Unresponsive to stimuli', 'Vomiting', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 975383,NV,79.0,F,Acute onset of SOB presented to ED and diagnosed with a pulmonary embolism. Tested positive for SARS-Co-V-2 on 01/25/21 using NAT.,Not Reported,,Not Reported,Yes,,Not Reported,N,12/20/2020,01/25/2021,36.0,PVT,"Aspirin, lisinopril, fludrocortisone, loperamide, prednisone, simvastatin",,"COPD, Hyperlipidemia",,"Seasonal allergies (pollen), motrin, sulfa, plaquenil","['Angiogram pulmonary abnormal', 'Blood creatinine increased', 'Blood glucose normal', 'Blood potassium normal', 'COVID-19 pneumonia', 'Chest X-ray normal', 'Defect conduction intraventricular', 'Dyspnoea', 'Electrocardiogram abnormal', 'Fibrin D dimer increased', 'Lung opacity', 'Lymphocyte percentage decreased', 'Neutrophil percentage increased', 'Pulmonary embolism', 'Red cell distribution width increased', 'SARS-CoV-2 test positive', 'Troponin']",1,MODERNA,IM 975399,SD,54.0,F,"1/13/21 woke at 4am with neck pain 1/14 Pain worse, could not move neck, radiated on both sides of neck to back of head, saw doctor, was given a muscle relaxant, pain worsened, went to ER was given valium and sent home 1/15 called doctor, was given hydrocodone, increased pain, went to ER due to pain, was hospitalized 1/19 discharged from hospital, off work till 2/3/2021 per PCP",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/12/2021,01/13/2021,1.0,PVT,,none,nodules on lung and liver (being monitored),,none,"['Computerised tomogram abnormal', 'Headache', 'Impaired work ability', 'Magnetic resonance imaging abnormal', 'Neck pain', 'Pain', 'Sleep disorder']",1,PFIZER\BIONTECH,IM 975420,OK,63.0,M,"pt developed a partial small bowel obstruction which required surgical intervention. He was found to have an adhesive band compressing the small intestine. There was no other signs of pathology in the abdomen. The pts only other surgical procedure was a right inguinal hernia repair which was distant from the site of the band. The pt began with persistent nausea, crampy pain and vomiting 5 days after his first dose of the Pfizer vaccine.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/14/2021,01/19/2021,5.0,PVT,"Micardis, Mirolax",None,"Essential hypertension, controlled Prediabetes",,Penicillin Erythromycin,"['Abdominal pain', 'Blood urea increased', 'Computerised tomogram abdomen abnormal', 'Dehydration', 'Haemoconcentration', 'Inguinal hernia repair', 'Metabolic function test', 'Nausea', 'Small intestinal obstruction', 'Surgery', 'Vomiting']",1,PFIZER\BIONTECH,IM 975421,MO,60.0,M,Resident was discovered deceased in his apartment on 1/23/2021. Family had,Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/01/2021,,SEN,"unknown medications for COPD, nebulizers, inhalers","Patient had reported on 8/8/2019 having arthritis, leg wounds, COPD, asthma, incontinence of bladder. Resident may also have had blood clots in his legs, per his sister.",Same as in Item 11.,,none known,['Death'],1,MODERNA,IM 975430,VA,51.0,M,"14th of jan i had a pain around my jaw got up the next day i started having water eyes, the right side of face started to droop. went to ER and was diagnosed with Belspaulsy. after that did a follow up appointment with neurology",Not Reported,,Not Reported,Not Reported,,Yes,N,01/06/2021,01/15/2021,9.0,WRK,"metformin 100 mg, Lipitor",,Diabetic,,,"['Blood test', 'Computerised tomogram', 'Facial paralysis', 'Lacrimation increased', 'Pain in jaw']",UNK,PFIZER\BIONTECH, 975434,IL,67.0,M,"vomiting x3 1/8/21 1/9/21 00:34 - called to resident room by CNAs, staff stated resident was ""different"". Vitals taken and 02 sat was low, O2 in room and applied via NC @3L, O2 sat returned to 98 and all other vitals WNL including BS. Resident asked how he felt, stated he felt ""okay"". Resident exhibiting some shakey movements and clearing throat, states he does not have any phlegm or drainage or trouble swallowing. MD called and updated on situation, voicemail left. 1/9/21 11am- resident has been making a ""growling"" noise this shift. resident also has tremors. resident alert and answers questions appropriately. when asked if resident wants to go to hospital, resident firmly states ""no"". vitals wnl. no emesis noted. will continue to monitor resident. 1/9/21 12p- resident not answering questions appropriately. resident only answering yes or no. resident cannot tell me name, or the year, resident cannot state where he is currently or birthdate.",Yes,01/09/2021,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/07/2021,5.0,SEN,"Renvela, Clopidogrel, Coreg, Aceteminophen, amLODIPine Besylate, Atorvastatin Calcium, Benzonatate, Calcium Acetate, Citalopram Hydrobromide, cloNIDine, Cozaar, Diclofenac, Docusate Sodium, Fluticasone-Umeclidin-Vilant Aerosol Powder Breath","OTHER INJURY OF UNSPECIFIED BODY REGION, SUBSEQUENT ENCOUNTER , LOCAL INFECTION OF THE SKIN AND SUBCUTANEOUS TISSUE, UNSPECIFIED , CELLULITIS OF LEFT LOWER LIMB, CELLULITIS OF RIGHT LOWER LIMB , END STAGE RENAL DISEASE , DEPENDENCE ON RENAL DIALYSIS , TYPE 2 DIABETES MELLITUS WITH DIABETIC CHRONIC KIDNEY DISEASE,UNSTEADINESS ON FEET , CHRONIC OBSTRUCTIVE PULMONARY DISEASE WITH (ACUTE) EXACERBATION, DIFFICULTY IN WALKING, NOT ELSEWHERE CLASSIFIED , MUSCLE WASTING AND ATROPHY, NOT ELSEWHERE CLASSIFIED, UNSPECIFIED SITE , COGNITIVE COMMUNICATION DEFICIT, REPEATED FALLS, OTHER LACK OF COORDINATION, SPINAL STENOSIS, LUMBAR REGION WITH NEUROGENIC CLAUDICATION, ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS, OTHER INTERVERTEBRAL DISC DISPLACEMENT, LUMBAR REGION, ESSENTIAL (PRIMARY) HYPERTENSION",listed in Item 11,,No Known Allergies,"['Abnormal behaviour', 'Blood glucose normal', 'Cardio-respiratory arrest', 'Computerised tomogram', 'Death', 'Disorientation', 'Grunting', 'Oxygen saturation decreased', 'Pneumonia', 'Pyrexia', 'Respiratory failure', 'Sepsis', 'Throat clearing', 'Tremor', 'Vomiting']",1,PFIZER\BIONTECH,SYR 975572,NC,72.0,F,Admitted for COVID-19 post vaccination,Not Reported,,Not Reported,Yes,13.0,Not Reported,Y,12/21/2020,01/01/2021,11.0,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH,IM 975573,KY,31.0,M,"History of Present Illness: Patient is a 31 y.o. male who is here today for a Gastroenterology Consultation for abdominal pain. He reports abdominal pain began abruptly 6 days ago. The pain is progressively worsened. Pain is from his chest to his testicles. Bilateral flank pain seems to be the worst. He is very tender to touch and it hurts when he walks. He began being jaundice the day after pain onset and presented to ER. CT abdomen showed splenomegaly and he was discharged with close outpatient follow-up. He was prescribed Cipro before that for possible UTI. Of note, jaundice and pain began before starting Cipro. For the past 3 days he has been experiencing fever at home, decreased appetite. Was having diarrhea that is very pale and now having no bowel movements and not able to pass gas. It is also associated with headaches. No indigestion or dysphagia. No alcohol use or illicit drug use. No new medications. Has been tested for Covid multiple times?did just recently get his Covid vaccine. Also tested negative for mono.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/07/2021,01/14/2021,7.0,UNK,Allegra,None,None,,NKDA,"['Abdominal distension', 'Abdominal pain', 'Alanine aminotransferase increased', 'Blood alkaline phosphatase increased', 'Blood bilirubin increased', 'Chest pain', 'Computerised tomogram abdomen', 'Computerised tomogram abdomen abnormal', 'Constipation', 'Cytomegalovirus test', 'Decreased appetite', 'Diarrhoea', 'Epstein-Barr virus antibody negative', 'Epstein-Barr virus antibody positive', 'Epstein-Barr virus antigen positive', 'Faeces pale', 'Flank pain', 'Headache', 'Hepatitis A antibody negative', 'Hepatitis B core antibody negative', 'Hepatitis B surface antigen negative', 'Hepatitis C antibody negative', 'Jaundice', 'Mononucleosis heterophile test negative', 'Pain', 'Pyrexia', 'Scan with contrast normal', 'Splenomegaly', 'Tenderness', 'Testicular pain']",UNK,MODERNA, 975664,,71.0,F,"Throat closing ER Visit 1: 25 mg Benadryl pill ER Visit 2: Epi Pen injection; IV PEPCID and MEDRA, Benadryl; Prescription for Famotidine, Methylprednisolone, continue Benadryl ER Visit 3: IV MEDRAL and Benadryl; Prescription for Epi Pens Throat is slightly better. Prednisone elevates my glucose levels, but am working real hard to keep them low.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/19/2021,01/22/2021,3.0,UNK,"CD-LD 24/100, Ropinirole, Metformin, Amlodipine, Atenolol, B-12, D-2, Biotin, Fish Oil",",",Parkinsons,,"lisinopril, penicillin, codeine, oxycodone, hydrochlorothiazide, aspirin 81, statins, clindamiacin","['Mononucleosis heterophile test negative', 'Streptococcus test negative', 'Throat tightness']",1,PFIZER\BIONTECH,IM 975689,AR,97.0,F,Resident vaccinated on 01/06/21 she acquired COVID 19 on 01/10/2021. Resident had multiple co morbidities and was declining prior to the vaccine. Resident expired on 01/20/2021,Yes,01/20/2021,Not Reported,Yes,5.0,Not Reported,N,01/06/2021,01/20/2021,14.0,SEN,"IBUPROFEN, VITAMIN D, ZINC, TRAMADOL, CRANBERRY, DULOXETINE, MIRALAX, ACIDOPHYLIS, ATIVAN, ASA, GUAUFENISEN",COVID 19 01/10/2021 HYPEROSMOLOTY AND HYPERNATREMIA HERNIA HYPERGLYCEMIA LOW BACK PAIN ANEMIA OSTEOPOROSIS DEMENTIA WITH BEHAVIORS CONSTIPATION CARDIAC MURMUR/HEART DISEASE POLYNEUROPATHY HX OF BREAST CANCER HTN DEPRESSION,,,PCN and NKFA,"['COVID-19', 'Death']",1,MODERNA,IM 975735,AR,83.0,F,VACCINE ADMINISTERED 01/06/21 ACQUIRED COVID 19 01/10/21 RESIDENT HAD MULTIPLE CO MORBIDITIES AND WAS DECLINING PRIOR TO VACCINE. RESIDENT EXPIRED ON 01/25/2021,Yes,01/25/2021,Not Reported,Yes,12.0,Not Reported,N,01/06/2021,01/25/2021,19.0,SEN,"zinc, acidophylis, albuterol inhaler, vitamin d, mirtazapine, Pepcid, vitamin c, Lasix, magnesium oxide, Depakote, cranberry, melatonin, Zoloft, folic acid, pericolace, simethicone, xarelto, asa, mvi with mineral, synthroid, evista,",COVID 19 01-10-2021 GERD DELUSIONS VASCULAR DEMENTIA WITH BEHAVIORS INSOMNIA CHRONIC DVT LEFT LOWER EXTREMITY HEMOCHROMATOSIS PSYCHOSIS MAJOR DEPRESSIVE DISORDER WITH ANXITY IMPULSE DISORDER VITAMIN DEFICIENCY EDEMA CONSTIPATION HALLUCINATIONS HYPOTHYROIDISM HX OF SKIN CANCER CARPAL TUNNEL LT HAND DYSTHYMIC HTN,ALZHEIMERS CONTRACTURE OF LEFT HAND,,"Aricept, codeine, hydrocodone, sulfa abx","['COVID-19', 'Death']",1,MODERNA,IM 975744,CA,87.0,F,See initial report,Yes,01/15/2021,Not Reported,Yes,,Not Reported,,01/07/2021,01/15/2021,8.0,SEN,"Atorvastatin Calcium 10mg, Ceftriaxone 1GM, Famotidine, Hydrocodone-Acetaminophen 5-325mg, Levothyroxine 25mcg, Senna, ASA, Docusate","The resident was febrile on 1/9/2021 after receiving the Pfizer vaccine on 1/7/2021. On 1/9/2021 UA, CBC, and CMP ordered indicating she had UTI. SARS-CoV-2 testing was performed using POCT GeneXpert on 1/9/2021. No SARS-CoV-2 was detected. The resident continued to decline and on 1/15/2021 she became tachycardiac and was having trouble breathing. She was transferred to ER where she later died.","Dementia, Hyperlipidemia, HTN, Hypothyroidism, left femur fracture, hx of COVID-19",,NKA,"['Death', 'Dyspnoea', 'Full blood count abnormal', 'General physical health deterioration', 'Metabolic function test abnormal', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tachycardia', 'Urinary tract infection', 'Urine analysis']",1,PFIZER\BIONTECH,IM 975762,ID,57.0,F,Pt deceased,Yes,01/24/2021,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/24/2021,4.0,PVT,,,- Hx of aortic dissection - Hx of mitral valve repair - Ascending aortic aneurysm (HCC) - Hearing loss of right year - Scoliosis of thoracolumbar spine - Fatigue - Overweight,,- Fish containing products - Kale - PCN,['Death'],2,MODERNA, 975821,WA,66.0,F,Patient was admitted to hospital for Pulmonary Embolism,Not Reported,,Not Reported,Yes,,Not Reported,U,01/21/2021,01/23/2021,2.0,PVT,,,,,,"['Activated partial thromboplastin time prolonged', 'Angiogram pulmonary abnormal', 'Pulmonary embolism']",1,MODERNA,IM 975888,NY,67.0,M,"I received my first vaccine on the 17th of December, I was exposed to COVID. I got COVID and was treated in the hospital for covid 19. Two weeks after the vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/17/2020,12/31/2020,14.0,PVT,,,Skin condition,,,"['COVID-19', 'Exposure to SARS-CoV-2', 'Full blood count', 'Liver function test', 'Renal function test', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,IM 975913,,57.0,F,"Tachypnea, Palpitations, HYPERtension & Angina Narrative: 12 HOURS AFTER VACCINE PT DEVELOPS TACHYCARDIA, CHEST PAIN, AND SHORTNESS OF BREATH. TREATMENT AT ER/ HOPSPITALIZATION FOR TWO DAYS.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/19/2021,01/19/2021,0.0,OTH,,,,,,"['Angina pectoris', 'Chest pain', 'Dyspnoea', 'Hypertension', 'Palpitations', 'Tachycardia', 'Tachypnoea']",2,PFIZER\BIONTECH,IM 975918,,61.0,M,death Narrative:,Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/17/2021,5.0,OTH,,,,,,['Death'],UNK,MODERNA,IM 975925,,66.0,M,Oral perioral paresthesias Narrative:,Not Reported,,Yes,Not Reported,,Not Reported,U,01/22/2021,01/22/2021,0.0,OTH,,,,,,['Paraesthesia oral'],1,PFIZER\BIONTECH,IM 975928,,43.0,M,"mild DRESS syndrome, rash, blood in urine. note it may have bene the doycycline, as simialr symptoms recurred later with a dose of doxy on jan 2nd, not hospitalized. pt is a MD",Not Reported,,Yes,Yes,3.0,Not Reported,Y,12/21/2020,12/22/2020,1.0,UNK,"naprosyn, doxycycline",none,"mgus, low T",,seasonal allergies,"['Blood urine present', 'Drug reaction with eosinophilia and systemic symptoms', 'Eosinophil count', 'Liver function test increased', 'Rash']",UNK,MODERNA,IM 975932,,80.0,M,"HYPOXIA Narrative: Patient received dose one of COVID vaccine and at the time was COVID negative (documented shortly before and after the vaccine). COVID test turned positive 14 days after first injection. He then received his second vaccine 4 days after positive test. 12 days after the second vaccine he was admitted to our facility and is currently in critical condition in the ICU with COVID pneumonia. It is unclear what role, if any the second vaccination had related to critical condition.",Not Reported,,Yes,Yes,,Not Reported,N,01/08/2021,01/20/2021,12.0,OTH,,,,,,"['COVID-19 pneumonia', 'Hypoxia', 'Intensive care', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,IM 975939,,73.0,M,COVID+ via biofire Narrative: Patient hospitalized for COVID-19 disease management given immunosuppressed status.,Not Reported,,Not Reported,Yes,,Not Reported,N,01/04/2021,01/23/2021,19.0,OTH,,,,,,"['Alanine aminotransferase', 'Aspartate aminotransferase', 'Blood creatinine', 'C-reactive protein', 'COVID-19', 'Immunosuppression', 'SARS-CoV-2 test positive', 'Serum ferritin']",1,MODERNA,IM 975946,,81.0,M,"fatigue Narrative: Did not feel good, appeared to have symptoms prior to getting vaccine, but had declined ER evaluation prior to vaccine. Pt was light headed, VS stable. Pt reported to have fatigue with exertion. Was sent to MER at 1:30p, routine labs revealed elevation in SCR and admitted for AKI. Pt was determined during admission to be volume depleted exacerbated by diuretics and administered IV fluids. follow-up appointment scheduled for 01/31/2021.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/10/2021,01/10/2021,0.0,OTH,,,,,,"['Acute kidney injury', 'Blood creatinine increased', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Hypovolaemia']",1,PFIZER\BIONTECH,IM 975952,,92.0,M,Narrative:,Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/16/2021,1.0,OTH,,,,,,['Death'],1,PFIZER\BIONTECH,IM 975959,NH,63.0,F,"anaphylaxis (throat tightness, swelling, pruritis, GI upset, cramping, diarrhea",Not Reported,,Not Reported,Yes,,Not Reported,N,01/26/2021,01/26/2021,0.0,OTH,acetaminophen (TYLENOL) 325 MG Oral Tab Take 1-2 Tabs by mouth EVERY 6 HOURS AS NEEDED. Unknown albuterol sulfate HFA 108 (90 Base) MCG/ACT Inhalation Aero Soln Inhale 2 Puffs EVERY 4 HOURS AS NEEDED for Shortness of Breath/Cough/Wh,None known,"Migraine Displacement of lumbar intervertebral disc without myelopathy Vestibular neuronitis Dyshidrosis Intestinal disaccharidase deficiencies and disaccharide malabsorption Peptic ulcer, unspecified site, unspecified as acute or chronic, without mention of hemorrhage or perforation Progressive muscular atrophy (CMS/HCC) Chondromalacia Temporomandibular joint disorders Other extrapyramidal disease and abnormal movement disorder Esophageal reflux Asthma Arthropathy, unspecified, site unspecified DEPRESSION MENARCHE Polyp of corpus uteri Other disorder of menstruation and other abnormal bleeding from female genital tract Unspecified pleural effusion ASHERMAN'S Other and unspecified ovarian cyst Acute gastritis without mention of hemorrhage Internal hemorrhoids without mention of complication Irritable bowel syndrome Acute bronchitis Stenosis of Cervix[622.4] Solitary cyst of breast Diffuse cystic mastopathy GERD (gastroesophageal reflux disease) Restless leg syndrome Pneumonia Central apnea H/O atrioventricular nodal ablation AF (atrial fibrillation) (CMS/HCC) Barrett's esophagus Malignant hypertensive heart disease without heart failure",,"Abilify Side Effect Not Specified 6/13/2011 Muscle stiffness Cartia Xt [Diltiazem Cd] Not Specified 9/4/2018 CHF Codeine Not Specified 1/20/2004 hyperactive Compazine Not Specified 10/23/2020 Dilaudid [Hydromorphone Hcl] Urticaria Not Specified 5/3/2006 Wheezing Diltiazem Not Specified 1/5/2020 chf after 3 days of taking Erythromycin Rash Not Specified 1/20/2004 Latex Not Specified 8/14/2004 Itching Levaquin Not Specified Patient Reported 2/12/2015 Joint pain - tolerates Cipro Metoclopramide Not Specified 1/20/2004 dystonic Metoprolol Not Specified 9/4/2018 Bronchospasm Morphine Sulfate Urticaria Not Specified 2/3/2004 wheezing Oxycodone-acetaminophen Not Specified 1/20/2004 hyperactive Penicillin V Potassium Not Specified 2/3/2004 rash Sulfa Drugs Rash Not Specified 1/20/2004 Xarelto [Rivaroxaban] Not Specified 9/4/2018 ""contraindicated because I'm on Prozac""","['Abdominal discomfort', 'Anaphylactic reaction', 'Diarrhoea', 'Muscle spasms', 'Pruritus', 'Swelling', 'Throat tightness']",UNK,MODERNA, 975997,CO,77.0,M,"On 1/20/21 the staff observed resident to be more restless constantly moving his legs. He had a decrease in his appetite and fluid intake and required assistance for consumption. His oxygen sats dropped to 89% on room air and was given oxygen at 2L. On 1/21/2021 the Resident observed moving restlessly, opened his eyes when this writer called his name, murmuring incoherent words, words were unclear, was observed taking off his Foley, attempting to grab something, dropped his hands and legs and at the same time restless. This writer was unable to auscultate lungs or heart, resident was moving uncontrollable. Resident positioned safely in bed. VS revealed high BP 147/101. MD ordered transfer to hospital. Resident was treated in the hospital for acute encephalopathy, sepsis with tachycardia and tachypenia and hypoxia.",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/19/2021,01/21/2021,2.0,SEN,"Atorvastatin Calcium Tablet 40 MG, Bactrim Tablet 400-80 MG, Cyanocobalamin Tablet 1000 MCG, Cymbalta Capsule Delayed Release Particles 60 MG, Flonase Suspension 50 MCG/ACT, Lasix Tablet 40 MG (Furosemide), Lidocaine Patch 5 %, Metoprolol","Resident of a long term car facility with chronic illness. He was treated for fever of unknown origin on 12/18/2020 with negative CXR, CBC and COVID-19 test. He has recurrent UTIs and is on prophylactic antibiotics. He was treated for pneumonia on 12/23/2020. Resident received first dose of COVID-9 vaccine on 12/22/2020.","COPD, Type 2 Diabetes, chronic UTIs, PTSD, atrial fibrillation, Chronic diastolic congestive heart failure, Insomnia, major depression, urinary retention with foley catheter",,"Cefepime, Morphine","['Blood urine present', 'Chest X-ray abnormal', 'Culture negative', 'Decreased appetite', 'Dyskinesia', 'Encephalopathy', 'Fluid intake reduced', 'Hypoxia', 'Incoherent', 'Loss of personal independence in daily activities', 'Lung opacity', 'Oxygen saturation decreased', 'Protein urine present', 'Red blood cells urine positive', 'Restlessness', 'SARS-CoV-2 test negative', 'Sepsis', 'Speech disorder', 'Tachycardia', 'Tachypnoea', 'Urine leukocyte esterase positive', 'Viral infection', 'White blood cells urine positive']",2,MODERNA,IM 976011,AK,71.0,F,"Began experiencing left sided weakness, Evaluated in ER, Medivac'd to other facility for stroke",Not Reported,,Not Reported,Yes,,Not Reported,U,01/19/2021,01/20/2021,1.0,PVT,unknown,unknown,unknown,,unknown,"['Cerebrovascular accident', 'Hemiparesis']",2,PFIZER\BIONTECH,IM 976019,CO,44.0,F,"Per summary of primary hospitalist. Pt admitted for acute hypoxic respiratory failure requiring mechanical ventilation secondary to angioedema from Moderna COVID-19 vaccination. Pt presented with a chief complaint of tongue and facial swelling approximately 10 minutes after receiving first dose of the vaccination. She did not respond to Benadryl or IM epinephrine. She was admitted to ICU and intubated. She was started on IVsteroids, famotidine and diphenhydramine. Swelling gradually improved and she was successfully extubated. Her hospital course was complicated by steroid-induced hyperglycemia requiring insulin.",Not Reported,,Yes,Yes,,Not Reported,U,01/20/2021,01/20/2021,0.0,PHM,Phenergan; Trileptal; Nortriptyline; Melatonin; Voltaren,None,Diabetes Mellitus; Asthma; Migraine headaches.,,"Pt denies any allergies to medications. Pt reports as a ""teen I was l allergic to citrus, barley, wheat, rice"". Pt states ""my lips and tongue swelling and I would take Benadryl"". Pt reports that she has ""since outgrown those food allergies"". Pt denies to her knowledge allergies to other products","['Angioedema', 'Endotracheal intubation', 'Hyperglycaemia', 'Intensive care', 'Mechanical ventilation', 'Respiratory failure', 'Swelling face', 'Swollen tongue']",1,MODERNA,IM 976032,CA,92.0,M,"Patient stated he wasn't feeling well on January 25, 2021, wasn't eating and complained of abdominal pain. Patient noted to have indigestion and was constipated. Meds provided and labs ordered. On morning of January 26, 2021, patient became weak, lethargic and hypoxic and was sent to emergency department around 0700 hours on January 26, 2021. At approximately 1100 hours, emergency physician notified this writer that patient was not going to overcome his illness and would be placed on comfort care. At approximately 1130 hours, this writer was notified that patient had passed away from multi-organ failure.",Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/26/2021,4.0,SEN,"Acetaminophen, Aspirin, Sinemet, Docusate, Eliquis, Finasteride, Fluticasone, Furosemide, Klor-con, Melatonin, Nortriptyline, Pantoprazole, Simvastatin, EMU muscle and joint relief cream, Synthroid, Tamsulosin, Vitamin B12, Vitamin D3, TUMS",CHF exacerbation in November 2020,"CHF, CAD w/CABG, Pacemaker, CKD IV, HTN, Hyperlipidemia, Hypothyroidism, Osteoarthritis",,No known allergies,"['Abdominal pain', 'Asthenia', 'Constipation', 'Death', 'Decreased appetite', 'Dyspepsia', 'Hypoxia', 'Lethargy', 'Malaise', 'Multiple organ dysfunction syndrome']",2,PFIZER\BIONTECH,IM 976036,,61.0,F,No problems with first vaccine. Started having severe head aches 2 days after the vaccine. Back Ache after 5 days on the right side. Throwing up 6 days after for 3 days. Went to the hospital 10 days later for four days was taken by ambulance because she was to ill to drive.,Not Reported,,Not Reported,Yes,4.0,Not Reported,,01/12/2021,01/14/2021,2.0,UNK,,,,,,"['Back pain', 'Headache', 'Impaired driving ability', 'Malaise', 'Vomiting']",2,PFIZER\BIONTECH,SYR 976078,VA,79.0,F,"After 1.5-2 hours after injection, patient blacked out on stairwell and fell down stairs. Patient struck head and received a concussion, broken nose, brain bleed, tear in the lip and damage to 6th cranial nerve in right eye. Patient has double vision now.",Not Reported,,Not Reported,Yes,2.0,Yes,N,01/21/2021,01/21/2021,0.0,PUB,Lisinopril Atenolol Januvia Fenofibrate Centrum multivitamin Vitamin D,No,Diabetes High blood pressure,,Sulfa,"['Cerebral haemorrhage', 'Computerised tomogram', 'Concussion', 'Cranial nerve injury', 'Diplopia', 'Facial bones fracture', 'Fall', 'Head injury', 'Lip injury', 'Loss of consciousness', 'Magnetic resonance imaging brain']",1,MODERNA,SYR 976111,,84.0,M,"CC:full arrest HPI:HPI and ROS limited due to patient's condition. History is via EMS, medical record, and son. Per Son patient had Covid vaccine on Saturday morning. Slept all day Sunday. Woke up Sunday night a bit ""like coming out of a deep sleep per son, around 10 pm. Shortly after that patient was having a hard time breathing. Emergency called. Arrested around the time EMS arrived. King airway, I/O and CPR initiated. Patient has been in v fib. Was shocked multiple times, given 4 rounds of epi, bicarb and amiodarone. ACLS continued on arrival. Multiple rounds of epi, and attempted defib. Patient given epi, bicarb. Rhythms included fine v fib, asystole, and PEA. Unrecoverable with no cardiac motion. Time of death 11:50 pm.",Yes,01/24/2021,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/24/2021,1.0,UNK,warfarin (COUMADIN) 2.5 mg tablet zinc sulfate 220 (50) mg capsule nutritional supplements (NUTREN 1.5) 0.07 gram-1.5 kcal/mL liqd acetaminophen (TYLENOL) 325 mg tablet senna (SENOKOT) 8.6 mg tab furosemide (LASIX) 40 mg tablet spironolacto,"Pt admitted with closed-loop bowel obstruction with subsequent surgery for ex-lap, SBR ~160cm jejunem and ileum, left with open abdomen with Abthera wound vac 12/22. Now s/p Exploratory laparotomy, primary stapled small bowel anastomosis, abdominal fascial and skin closure on 12/24.","Neurology Myalgia Secondary hypothyroidism � Cardiovascular Coronary atherosclerosis of native coronary artery Postsurgical aortocoronary bypass status Chronic atrial fibrillation (HCC) Aortic insufficiency RBBB Essential hypertension, benign Pure hypercholesterolemia Bradycardia Typical atrial flutter (HCC) Severe aortic stenosis History of acute anterolateral myocardial infarction Thoracic aortic aneurysm without rupture (HCC) Ischemic cardiomyopathy Coronary artery disease involving autologous vein coronary bypass graft without angina pectoris Acute on chronic systolic heart failure (HCC) Acute on chronic systolic (congestive) heart failure (HCC) Chronic systolic congestive heart failure (HCC) � Gastrointestinal Malnutrition of moderate degree (HCC) � Nephrology BPH with obstruction/lower urinary tract symptoms Stage 3 chronic kidney disease (HCC) � Endocrinology Acquired hypothyroidism � Genetics/Metabolics Chronic gout of ankle � Ophthalmology Nuclear sclerotic cataract of right eye Pseudophakia of left eye Exudative age-related macular degeneration of left eye with active choroidal neovascularization (HCC) Ocular trauma of right eye � Rheumatology Primary localized osteoarthrosis, pelvic region and thigh � Musculoskeletal Left leg swelling � Psychiatry Delirium � Other Statin intolerance Transient global amnesia CVA, �Possible lacunar infarct right cerebellar Long term current use of anticoagulant therapy",,Statins (muscle weakness),"['Cardiac arrest', 'Cardio-respiratory arrest', 'Cardioversion', 'Death', 'Dyspnoea', 'Pulseless electrical activity', 'Resuscitation', 'Somnolence', 'Ventricular fibrillation']",2,PFIZER\BIONTECH,IM 976112,CA,81.0,F,"Resident expired on january 21, 2021",Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/10/2021,3.0,SEN,Metoprolol Tartrate Tablet 25 MG BID Norvasc Tablet 10 MG (amLODIPine Besylate) QD Namenda Tablet 5 MG (Memantine HCl) BID Cozaar Tablet 100 MG (Losartan Potassium) QD hydrALAZINE HCl Tablet 25 MG TID Amiodarone HCl Tablet 200 MG QD CloNID,"Resident started manifesting loss of appetite and body weakness on January 10,2021 a few days after vaccination. She expired in our facility 1/21/2021.",HEMIPLEGIA AND HEMIPARESIS FOLLOWING OTHER NONTRAUMATIC 10/28/2020 Principal Diagnosis INTRACRANIAL HEMORRHAGE AFFECTING LEFT DOMINANT SIDE TYPE 2 DIABETES MELLITUS WITHOUT COMPLICATIONS DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE UNSPECIFIED ATRIAL FIBRILLATION ENTIAL (PRIMARY) HYPERTENSION 10/28/2020 Diagnosis 4 Admission HISTORY OF FALLING 10/28/2020 Diagnosis 5 Admission OTHER ABNORMALITIES OF GAIT AND MOBILITY 01/13/2021 Other Diagnosis During Stay COVID-19,,ASPIRIN PENICILLIN,"['Asthenia', 'Death', 'Decreased appetite']",1,MODERNA,IM 976123,NJ,58.0,F,"Having Ehlers Danlos and Mast Cell Degranulation as well as Dysautonomia... Anaphylaxis is often referred to as slow roll and without the typical face swelling and rash. It is more subtle and can be harder to detect. And that was my experience: as follows: I became faint and briefly passed out within 2 minutes of injection. I stabilized quickly within a 30 minute hold although developed increasing nausea, I and med tech was satisfied that it might just be my dysautanomia. I spent the evening with severe headache vomiting as passed out again. I experienced throat tightening but not full closure. The next day I had flue like symptoms that I assume were normaland vaccine related. When this passed in the evening I again suffered nausea and dizziness, vomiting and throat tightening when I tried to eat. These symptoms were not similar to the flush feelings earlier in the day. The symptoms ebbed and waned for 2 days with increased frequency as I took chromalyn , Benadryl with some effect at first and ate with great care as not to introduce more allergens. I had increased chest pain, sweating, fainting, throat tightening became severe Benadryl was not effective. I was having trouble swallowing. I was forced to us an epi pen and call 911. This is a typical anaphylactic response for EDS< Mast Cell patients. It became clear that I could not get past this on my own and the symptoms were increasing. I started to shake with chills and feared shock as my chest pains increased. The epi pen injection and hospital visit via ambulance occurred Monday 1/25-1/26. I became very faint during the Ems intake with the techs having to hold me up to check vitals etc.. My HR dropped despite the EPi. At the ER I was given IV steroids, IV Benedryl and Potassium, tablets and fluids throughout the night, admitted for evaluation.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,01/21/2021,01/21/2021,0.0,PVT,"Benadryl, Chromelyn, Zyrtec, Zonizamide, Aloe vera, Vitamin D,",none,"Ehlers Danlos with Mast Cell Degranulation and Dysautonomia. Neg ANA Lupus-Pos C complex, Interstitial Cystitis , Migraine frequent, Arrhythmia,",,"Augmentum, Antiemetics, Benzos, narcotics, muscle relaxants, Ventolin, bee stings, mold, pollen-tree, flower, apple and pear skin, grass, evergreens, chocolate, eggs (but I eat them with out symptoms-did not eat for two weeks prior to inject), garlic salt, fragrance, nitrile gloves (mucosal contact only) adhesive tape-localized response only.","['Anaphylactic reaction', 'Blood test', 'Chest X-ray', 'Chest pain', 'Chills', 'Dizziness', 'Dysphagia', 'Electrocardiogram', 'Fear', 'Flushing', 'Headache', 'Heart rate decreased', 'Hyperhidrosis', 'Influenza like illness', 'Loss of consciousness', 'Nausea', 'Syncope', 'Throat tightness', 'Vomiting']",1,MODERNA,SYR 976146,CA,86.0,F,Resident is asymptomatic,Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/21/2021,14.0,SEN,Multivitamin Liquid (Multiple Vitamins-Minerals) Give 5 ml via G-Tube one time a day for (SUPPLEMENT) Aspirin Tablet Chewable 81 MG Give 1 tablet via G-Tube one time a day for (CVA PROPHYLAXIS) Norvasc Tablet 5 MG (amLODIPine Besylate) G,No symptoms after COVID vaccinations,"ENCOUNTER FOR SURGICAL AFTERCARE FOLLOWING SURGERY ON THE DIGESTIVE SYSTEM ENCOUNTER FOR ATTENTION TO GASTROSTOMY CONTACT WITH AND (SUSPECTED) EXPOSURE TO OTHER VIRAL COMMUNICABLE DISEASES UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE DEGENERATIVE DISEASE OF NERVOUS SYSTEM, UNSPECIFIED ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS UNSPECIFIED SEQUELAE OF UNSPECIFIED CEREBROVASCULAR DISEASE PAROXYSMAL ATRIAL FIBRILLATION UNSPECIFIED CIRRHOSIS OF LIVER ESSENTIAL (PRIMARY) HYPERTENSION UNSPECIFIED VIRAL HEPATITIS B WITHOUT HEPATIC COMA HYPERLIPIDEMIA, UNSPECIFIED GASTRITIS, UNSPECIFIED, WITHOUT BLEEDING UNSPECIFIED PROTEIN-CALORIE MALNUTRITION",,None,['Asymptomatic COVID-19'],1,MODERNA,IM 976166,CA,93.0,F,ASYMPTOMATIC,Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/18/2021,11.0,SEN,"Gabapentin Capsule 100 MG, Give 1 capsule orally one time a day for (NEURALGIA) Losartan Potassium Tablet 50 MG, Give 1 tablet orally one time a day for (HYPERTENSION) HOLD IF SBR<110 OR HR<60 Norvasc Tablet 5 MG (amLODIPine Besylate), Give",NONE,"HEMIPLEGIA AND HEMIPARESIS FOLLOWING NONTRAUMATIC INTRACEREBRAL HEMORRHAGE AFFECTING RIGHT DOMINANT SIDE CONTACT WITH AND (SUSPECTED) EXPOSURE TO OTHER VIRAL COMMUNICABLE DISEASES ACIDOSIS ANEMIA UNSPECIFIED SEVERE PROTEIN-CALORIE MALNUTRITION PERSONAL HISTORY OF OTHER MALIGNANT NEOPLASM OF LARGE INTESTINE ACUTE KIDNEY FAILURE, UNSPECIFIED UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE NEURALGIA AND NEURITIS, UNSPECIFIED ESSENTIAL (PRIMARY) HYPERTENSION",,NONE,['Death'],1,MODERNA,IM 976265,CA,39.0,F,"6 days after receiving the first dose, I suddenly noticed a circular area of redness, swelling, and itchiness around the injection site. 3 inches in diameter. It has been 5 days and is still mildly red, swollen, and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/19/2021,6.0,PVT,Prenatal vitamin,No e,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 976280,LA,75.0,F,Death on 21 Jan 2021 - coroner called provider office,Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,,01/21/2021,,PVT,,,,,GABAPENTIN; PREGABALIN,['Death'],1,PFIZER\BIONTECH,IM 976284,GA,74.0,M,"Felt strange 5 days after getting shot, weakness in legs, fatigued. Next day started having slurred speech, weakness in bil lower ext.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/18/2021,01/23/2021,5.0,PUB,"Amlodipine 5 mg q day, Toujeo pen 30 to 60 Units at HS, Glimperde 4 mg q day PRN, ASA 325 mg q day, Vit D3 2000 IUs q day, Vit C 500 mg q day, Vit B12 1000 mcg q day, Folate 400 mcg q day",None,"Type 2 diabetes, HTN",,NKDA,"['Cerebrovascular accident', 'Computerised tomogram head normal', 'Dysarthria', 'Fatigue', 'Feeling abnormal', 'Magnetic resonance imaging brain abnormal', 'Muscular weakness']",1,MODERNA,IM 977022,LA,89.0,M,admitted to hospital within 4 days after vaccine COVID +,Not Reported,,Not Reported,Yes,2.0,Not Reported,U,,01/20/2021,,PVT,,,,,ALPHA 2 ADRENERGIC AGONIST; BETA-BLOCKERS (BETA-ADRENERGIC BLOCKING AGTS),['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH,IM 977023,WI,86.0,M,Bell?s palsy on left side (onset 01/24) T/t Valacylovir 1000 mg PO TID x 1 week and prednisone 60 mg PO Daily x 1 week.,Not Reported,,Not Reported,Not Reported,,Yes,,01/12/2021,01/23/2021,11.0,OTH,,,,,,['Facial paralysis'],UNK,PFIZER\BIONTECH,IM 977031,LA,84.0,M,admitted 21 Jan 21for Chest pain; Elevated troponin; Hypokalemia; SOB (shortness of breath); Shortness of breath; Volume depletion Dishcarged on 23 Jan 21,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/18/2021,01/21/2021,3.0,PVT,,,,,DOXYCYCLINE,"['Chest pain', 'Dyspnoea', 'Hypokalaemia', 'Hypovolaemia', 'Troponin increased']",1,PFIZER\BIONTECH,IM 977050,LA,77.0,F,"admitted to hospital on 21 Jan 21 with Acute cystitis without hematuria; Cardiovascular disease; Diarrhea; ST segment depression; Syncope, unspecified syncope type Discharged on 26 Jan 21",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/20/2021,01/21/2021,1.0,PVT,,,,,CIPROFLOXACIN; DILTIAZEM HCL; IODINATED CONTRAST MEDIA; IODINE; SULFAMETHOXAZOLE-TRIMETHOPRIM,"['Cardiovascular disorder', 'Cystitis', 'Diarrhoea', 'Electrocardiogram ST segment depression', 'Syncope']",1,PFIZER\BIONTECH,IM 977711,NY,71.0,M,"The patient lives in a group home. He was noted to have fever, cough and oxygen saturation was 93%. He was sent to the hospital. COVID test was negative. He was admitted for rule out pneumonia. He also had lower sodium (123) than previous baseline of 130. His antibiotics were stopped on day 2 of admission because fever resolved, chest x-ray was clear and oxygenation was improved. He was observed, remained stable and then discharged on his usual medications on 1/26/21.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/21/2021,01/23/2021,2.0,OTH,"lacosamide, valproic acid, sertraline, melatonin, atorvastatin",None,"bipolar disorder, intellectual disability, GERD, constipation, hyponatremia, osteoporosis",,latanoprost eye drops,"['Blood sodium decreased', 'Chest X-ray normal', 'Cough', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 976513,PR,31.0,F,"Itching; redness; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date were unknown), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. Medical history was reported as none. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior to vaccination. She has no known allergies. The patient's concomitant medications were not reported. No other vaccines in four weeks prior to COVID vaccine. No other medication in two weeks. On 10Jan2021, the patient experienced itching and redness. Benadryl was given as treatment for the events. The events resulted in emergency room/department or urgent care. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Erythema', 'Pruritus']",UNK,PFIZER\BIONTECH, 976525,OR,72.0,F,"severe reaction; her whole body system ultimately shut down; er blood count was all over the chart; she came close to dying; it started out looking like it was cellulitis but went through her body/infectious disease; Lethargic; her urine was off; it started out looking like it was cellulitis; This spontaneous report has been received from a 72 year old female patient reporting on herself. The patient's concurrent conditions included hypertension, drug hypersensitivity, hypersensitivity, and allergy to arthropod sting. Her medical history included sepsis, and 2 hip arthroplasties. Historical drugs included sulfamethoxazole, trimethoprim (BACTRIM), unspecified flu vaccine, and unspecified antibiotic. Her concomitant medications included lisinopril (Manufacturer unknown), unspecified flu vaccine, and an unspecified vaginal tablet. On 09-OCT-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S018140, expiration date not reported but upon internal validation established as 02-MAR-2021) for prophylaxis, strength, and route of administration were not reported. At the same time, the patient was also vaccinated with a shot of unspecified flu vaccine in the same arm. On the same date, after vaccination the patient experienced a severe reaction (vaccination complication), she stated that her whole body system ultimately shut down (ill-defined disorder), her blood count was all over the chart (full blood count increased), and she was close to dying (near death experience). She also stated, that it started out looking like it was cellulitis, but went through her body (cellulitis/sepsis), she was very sick, lethargic, and her urine was off (Anuria). She reported that she was working with an infectious disease. Due to this, she sought medical attention, and she stated that she ended up in the hospital for 3 days (unspecified dates). The patient was treated with intravenous (IV) antibiotics. On an unknown date in January 2020, the patient recovered from the adverse events. She reported that the doctor and ""they"" had determined that it was in fact the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine that had caused her reaction. Moreover, she stated that she had always the flu shot every year, but since she had the ""13 vaccine"", they wanted her to go ahead and get the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), reported as (23 vaccine). The reporter considered the adverse events to be life threatening. Upon internal review the patient's anuria, sepsis, and near death experience were considered medically significant. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S018140; expirationdate: 02-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability",Not Reported,,Yes,Yes,3.0,Not Reported,Y,10/09/2019,10/09/2019,0.0,UNK,influenza virus vaccine (unspecified); PRINIVIL,Allergic reaction to antibiotics; Allergic reaction to bee sting; Allergy; Blood pressure high; Sulfonamide allergy,Medical History/Concurrent Conditions: Hip replacement; Sepsis,,,"['Adverse reaction', 'Anuria', 'Cellulitis', 'Full blood count', 'Ill-defined disorder', 'Lethargy', 'Malaise', 'Near death experience']",UNK,MERCK & CO. INC., 976526,PA,,U,"retinal eye detachment; zoster-related eye conditions; other zoster-related conditions; zoster-related eye conditions / other zoster-related conditions; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or about 13-AUG-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On unknown dates, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by various healthcare providers, including but not limited to healthcare provider at an eye hospital, as well as other healthcare providers, for zoster-related eye conditions, retinal eye detachment, and other zoster-related conditions. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of zoster-related eye conditions, retinal eye detachment, and other zoster-related conditions to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of retinal detachment was determined to be medically significant.",Not Reported,,Not Reported,Yes,,Not Reported,N,08/13/2015,,,PHM,,,,,,"['Ill-defined disorder', 'Retinal detachment']",UNK,MERCK & CO. INC.,OT 976711,NY,67.0,F,"7 hours after shot I had severe vomiting and diarrhea and chills; 7 hours after shot I had severe vomiting and diarrhea and chills; 7 hours after shot I had severe vomiting and diarrhea and chills; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly into the left arm on 11Jan2021 02:45 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly into the left arm on 21Dec2020 03:00 at a single dose for covid-19 immunization at the age of 67-year-old as well. On 11Jan2021 09:45, 7 hours after the shot she had severe vomiting, diarrhea and chills. The patient received no treatment for the events reported and was not pregnant at the time of administration of the vaccine. Outcome of the events recovered on an unspecified date in Jan2021. Information on lot number/batch number was requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,,,,,,"['Chills', 'Diarrhoea', 'Vomiting']",2,PFIZER\BIONTECH,OT 976712,MO,,M,woke up with the shakes; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient woke up with the shakes on an unspecified date in Jan2021 after receiving the vaccine. Outcome of event was unknown. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/01/2021,,UNK,,,,,,['Tremor'],UNK,PFIZER\BIONTECH, 976713,WI,25.0,M,"received the first dose of the vaccine on 30Dec2020 in a hospital. On 07Jan2021, he tested positive for COVID.; received the first dose of the vaccine on 30Dec2020 / On 07Jan2021, he tested positive for COVID / COVID symptoms; This is a spontaneous report from a contactable healthcare professional (patient) via a Pfizer-sponsored program. A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL1284, unknown lot number), intramuscular in left deltoid on 30Dec2020 at 19:30 at a single dose for COVID-19 immunisation/to prevent getting sick, to prevent the spread. Medical history and concomitant medication reported as none. The patient received the first dose of the vaccine on 30Dec2020 in a hospital. On 07Jan2021, he tested positive for COVID. His second dose is scheduled on 22Jan2021 and wants to know if he should get that or if there is any recommendation. The patient clarified that the COVID symptoms began on 06Jan2021. On the night of the 6th, he started to have chills and a headache throughout the night. He never had a fever or anything. He woke in the morning of 07Jan2021 kind of congested; runny nose, clear discharge. The patient wasn't able to taste his toothpaste, and then he couldn't smell his coffee. So, he experienced a loss of taste and smell. He was then tested for COVID (rapid test) on 07Jan2021 and tested positive. It was worse 2 days after he got sick. The patient progressively gotten better each day. The patient felt good today. He still can't taste or smell fully, some of it is coming back though. No additional vaccines administered on same date and no prior vaccinations within 4 weeks. The patient did not require a visit to emergency room/ physician office. The patient underwent lab tests and procedures which included COVID Rapid test: positive on 07Jan2021. The patient was recovering from the events chills, headache, ""congested- runny nose, clear discharge"", and Loss of taste and smell, while unknown outcome for the remaining events. The patient would consider the seriousness as not significant.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/07/2021,8.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Ageusia', 'Anosmia', 'Chills', 'Headache', 'Malaise', 'Respiratory tract congestion', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 976714,,,F,"Fever chills; Fever chills; This is a spontaneous report from a non-Contactable Consumer (patient sister). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration on unspecified date at a single dose (1st dose and 2nd dose) for covid-19 immunization. Relevant medical history included virus before she got the vaccine. On an unspecified date, patient got the vaccine and had fever chills after it. Patient received 2nd dose took Tylenol and Zyrtec before the dose. The reporter asked if that was not recommended and if could affect the efficacy. The outcome of the events was unknown. No follow up attempts are possible. Information on Lot/Batch number could not be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: COVID-19 (Also mentioned his Sister had the virus before got the vaccine and had fever chills after it),,,"['Chills', 'Pyrexia']",2,PFIZER\BIONTECH, 976715,,,F,"received her first dose of the COVID-19 vaccine/she tested positive for COVID-19; received her first dose of the COVID-19 vaccine/she tested positive for COVID-19; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 26Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the COVID-19 vaccine on 26Dec2020. Five days later she started having symptoms and then she tested positive for COVID-19 on 04Jan2021. She is scheduled to receive her second dose this Saturday, 16Jan2021, and would like to know if she should still proceed with this scheduled dose on that date since she currently has a COVID-19 infection. The patient stated that the nurse practitioner she went to mentioned waiting 30 days, but she wanted to check with Pfizer. Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,01/04/2021,9.0,UNK,,,,,,"['Adverse event', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 976716,MA,31.0,F,"Mild headache; mild low back pain; fever/Peak temp was 101.4F; This is a spontaneous report from a contactable physician (patient). A 31-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the left arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization. The patient was vaccinated in a workplace clinic facility. Medical history included known allergies to egg whites and yogurt. The patient has no covid prior vaccination. Concomitant medications included vitamin d3 and cyanocobalamin (VITAMIN B12). The patient has no other vaccine in four weeks. On 24Dec2020, the patient experienced mild headache, mild low back pain, and fever which started 20-24 hours after vaccine was given. Peak temp was 101.4F about 32 hours after vaccine was given (24Dec2020 20:00). The patient did not take any medication for it (no acetaminophen, no NSAIDs). Temperature was 98.9F at 44 hours after vaccine (25Dec2020 08:00). All symptoms resolved on their own within 48 hours (26Dec2020). The covid test post vaccination showed that patient had negative covid test result based on nasal swab on 26Dec2020. Information about the lot/batch number and expiry date were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,WRK,VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN],,Medical History/Concurrent Conditions: Egg allergy; Food allergy,,,"['Back pain', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH, 976717,NJ,37.0,M,"Hives scattered on my face, neck and arms; This is a spontaneous report from a contactable physician (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no: EH9899, expiry date not reported), via an unspecified route of administration on 20Dec2020 at a single dose (1st dose) then via an unspecified route of administration on 10Jan2021 (lot no: EK9231, expiry date not reported) at a single dose (2nd dose); both on left arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. To his knowledge, patient has no known allergies. Patient had no other vaccine received in four weeks. Patient had One a Day multivitamin in two weeks. The patient stated on 23Dec2020, ""The days after the first vaccine I had a couple hives scattered on my face, neck and arms. After the second vaccine, the hives increased in size and number. It really progressed today (3 days after the second shot)"". The patient took BENADRYL, PEPCID and prednisone as a treatment for the events. Patient had no prior COVID vaccination and had not tested COVID post vaccination. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/23/2020,3.0,PVT,,,,,,['Urticaria'],1,PFIZER\BIONTECH, 976718,KY,30.0,M,"feel his chest and neck hurting; feel his chest and neck hurting; feeling really sick; feeling tired; arms hurting; head hurting/ neck and all around head area, hurting real bad; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization (reported as ""I guess to protect myself from other people, to protect myself""). There were no medical history and concomitant medications. The patient took his first dose on 20Dec2020, 3 weeks from there, he took the second on 10Jan2021 (reported as ""it was 10th it was Sunday morning when I took it""). The patient reported that he had his second dose on Sunday morning (10Jan2021) and started feeling tired last Monday (11Jan2021). Then on 12Jan2021 (reported as ""yesterday"" at the time of reporting), he started to feel his chest and neck hurting. The patient stated that he woke up in the middle of the night (Sunday night) and Monday morning, he was feeling really sick so he called out rest all day on Monday (11Jan2021). Then patient woke up yesterday morning (12Jan2021) feeling good then probably about 6 o'clock last night he started feeling tired, like real bad tired and he got home. Patient lied down and woke up in middle of night, his chest, arms and head were hurting. His neck and all around head area were hurting real bad. The events were assessed as non-serious. The patient does not have the lot number but stated that it was the Pfizer vaccine. When the patient was asked if still experiencing tiredness and chest hurting, he stated ""When I started, that was last night on I will go with the 12 before midnight 12 (not clear). Yes right now yeah. This is the first time my chest and my arms and my neck and like all that has been hurting, started last night"". When asked for the treatment, the patient answered ""I took Ibuprofen to calm it down a little bit. I took Ibuprofen if you count that as a treatment"". Outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Chest pain', 'Fatigue', 'Headache', 'Malaise', 'Neck pain', 'Pain in extremity']",2,PFIZER\BIONTECH, 976719,FL,71.0,F,"Nausea; Chills; Sweating; General unwell feeling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration at the right arm on 11Jan2021 13:45 at a single dose for covid-19 immunization. Medical history included allergic to shellfish and allergic reaction to bee sting 50 years ago. Concomitant medication included losartan potassium (strength: 100 mg) and atorvastatin calcium (ATORVA). The patient experienced nausea, chills, sweating and general unwell feeling on 13Jan2021 12:15. The patient took two paracetamol (TYLENOL) as treatment for the events. The patient was not pregnant at the time of administration. Outcome of events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/13/2021,2.0,PVT,LOSARTAN POTASSIUM; ATORVA,,Medical History/Concurrent Conditions: Allergic reaction to bee sting; Shellfish allergy,,,"['Chills', 'Hyperhidrosis', 'Malaise', 'Nausea']",1,PFIZER\BIONTECH, 976720,NY,36.0,F,"exposure to someone positive to the COVID virus; She was exposed to COVID a week ago and has tested positive; She was exposed to COVID a week ago and has tested positive; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 23Dec2020 at a single dose as she doesn't want COVID. Medical history included occasional mild hypertension since Mar2019 and ongoing anxiety depression. Concomitant medication included sertraline hydrochloride (ZOLOFT) since Aug2020 for anxiety depression. The patient reported that she is supposed to get the second dose of the vaccine today (13Jan2021). She was exposed to COVID a week ago and has tested positive on 06Jan2021. She does not have any symptoms. She tested negative on 08Jan2021. She will be tested again today. She is asking if it is still ok to get the second vaccine after having exposure to someone positive to the COVID virus. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/06/2021,14.0,UNK,ZOLOFT,Anxiety depression; Hypertension,,,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 976721,FL,,F,"tested positive for COVID after receiving the first dose; tested positive for COVID after receiving the first dose; This is a spontaneous report from a contactable consumer reporting on behalf of the patient via a Pfizer-sponsored program. A female patient (mother) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter mentioned that her mother tested positive for COVID after receiving the first dose. The reporter wanted to know when will the patient take the second dose since she is COVID positive. The patient is in the nursing home. Outcome of the events was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 976722,CA,,M,"Vigorous chills (afebrile); Some sensitivity over his nose; Painful and tender lymphadenopathy on the axillary area on the same arm as the injection site; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, on 11Jan2021, at a single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously had his first dose of COVID-19 vaccine on an unspecified date. It was reported that the patient had the second dose of the COVID-19 vaccine on 11Jan2021, and on 12Jan2021, he had a painful and tender lymphadenopathy on the axillary area on the same arm as the injection site. He had no issues with the first shot. He also reported that he has been taking an antihistamine and the lymphadenopathy is going away. He also had vigorous chills (afebrile) when the event first took place for 2-3 hours. He had some sensitivity over his nose which was also improving with the antihistamine. The outcome of the events ""painful and tender lymphadenopathy on the axillary area on the same arm as the injection site"" and ""some sensitivity over his nose"" was recovering, and the other event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/12/2021,1.0,UNK,,,,,,"['Chills', 'Lymphadenopathy']",2,PFIZER\BIONTECH, 976723,FL,,F,"diarrhea; mild abdominal pain; tiredness on legs; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 70, unknown unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 11Jan2021; however, the facility didn't provide the time she should show up on 01Feb2021. She was looking for the time right here at Pfizer MI. She also stated that she has been having diarrhea, mild abdominal pain and tiredness on legs, but she doesn't attribute it entirely to the vaccine, it might be related. She mentioned that her arm was not in such expected pain. The outcome of the events was unknown. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,,,UNK,,,,,,"['Abdominal pain', 'Diarrhoea', 'Fatigue', 'Limb discomfort']",1,PFIZER\BIONTECH, 976724,MD,39.0,M,"tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 39-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 24Dec2020 at a single dose for him to not get COVID. Medical history and concomitant medications reported as none. The patient is a surgical technician who received his first dose of vaccine on 24Dec2020 and tested positive for COVID-19 on 05Jan2021. Patient's quarantine ends tomorrow, and he is also due for his second dose, tomorrow (14Jan2021). He is asking what to do as far as taking it or not. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,01/05/2021,12.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 976725,,28.0,F,"Fever up to 102 after 12 hours of vaccine/Continuing fever throughout next day; low grade fever at 36h; Aches; chills; This is a spontaneous report from a non-contactable physician (patient). A 28-year-old female patient received the second dose bnt162b2 (reported as COVID 19 vaccine, brand: Pfizer) via an unspecified route of administration in left arm on 11Jan2021 11:30 at a single dose for COVID-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of report. The patient previously received the first dose of bnt162b2 on 21Dec2020 11:30 in left arm for COVID-19 immunization at age 28 years old; azithromycin and experienced allergies. No other vaccines were administered in four weeks. The patient was not covid tested post vaccination. On 11Jan2021 23:30, the patient experienced fever up to 102 after 12 hours of vaccine, aches, chills. Continuing fever throughout next day and still had low-grade fever at 36h. Treatment was not given for AEs. The patient was recovering from the events. No follow-up attempts are possible. Information on lot number, batch number could not be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,PVT,,,,,,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 976726,MD,51.0,F,"Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; Fever; headache; bodyaches; cough; tiredness; sore throat; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 05Jan2021 at 08:15 AM at a single dose for COVID-19 immunization in a hospital. Medical history included known allergies to mold, dust mites, grass and tree pollen, cockroaches. Concomitant medications included hydroxyzine, ergocalciferol (VITAMIN D), vitamin c, calcium, and glucose (GLUCOS). The patient experienced fever, headache, bodyaches, cough, tiredness, sore throat on 10Jan2021 at 08:30 AM. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received zinc, vitamin D, ibuprofen, and Tylenol as treatment for the events. Since the vaccination, has the patient been tested for COVID-19: Yes. The patient has no COVID prior to vaccination and she was tested for COVID post vaccination (nasal swab; COVID-19 Ag test) with COVID test result as positive on 12Jan2021. The patient did not receive other vaccine in four weeks. Outcome of the event ""Since the vaccination, has the patient been tested for COVID-19:Yes"" was unknown, while recovering for the remaining events. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for COVID test based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/10/2021,5.0,PVT,HYDROXYZINE; VITAMIN D [ERGOCALCIFEROL]; VITAMIN C [ASCORBIC ACID]; CALCIUM; GLUCOS,,Medical History/Concurrent Conditions: Allergy to molds; Cockroach allergy; House dust mite allergy; Pollen allergy,,,"['Cough', 'Fatigue', 'Headache', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 976727,,55.0,F,"mouth was dry; sense of taste was not the same; This is a spontaneous report from a contactable other health professional. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Jan2021, the patient experienced that her mouth was dry and her sense of taste was not the same. The outcome of events was unknown. Follow-up attempts are completed. The following information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/12/2021,4.0,UNK,,,,,,"['Dry mouth', 'Taste disorder']",1,PFIZER\BIONTECH, 976728,MS,40.0,F,"woke up during the night after her second dose (dose given on Friday) with joint pain (around midnight or shortly after); joint pain; intense fatigue; muscle aches; arm was sore at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 08Jan2021 (11:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EH9899) on 18Dec2020 (02:45 PM) via an unspecified route (right arm) for Covid-19 immunization. The patient's medical history included drug allergy (reported as known allergies: Cephalosporin (mild reaction of hives one time after having taken it with no issues for years-pending clarification)). There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that she woke up during the night after her second dose (dose given on Friday) with joint pain (around midnight or shortly after [09Jan2021, 12:15AM]). The entire day after her 2nd dose (during the day Saturday) every joint in her body ached and she experienced intense fatigue. There were also some muscle aches in her shoulders and her arm was sore at the injection site as it usually is after a tetanus shot (she stated she had soreness in her arm the day after the first injection but no other adverse events after the first injection). She did not seek medical treatment and did not take any over the counter medications to alleviate the symptoms as she does not typically take medications unless absolutely necessary. By the next day (Sunday), she was much better and had only slight joint pain remaining in her neck. By the following day (Monday;11Jan2021), all symptoms had resolved. She further stated that the symptoms experienced for one day did not make her regret getting the vaccine and she continue to strongly recommend the vaccine. The outcome of events was recovered on 11Jan2021. The patient has not been tested for COVID-19 since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Drug allergy (Cephalosporin (mild reaction of hives one time after having taken it with no issues for years)),,,"['Arthralgia', 'Fatigue', 'Injection site pain', 'Myalgia']",2,PFIZER\BIONTECH, 976729,IL,28.0,F,"Fever (highest at 101.8); Chills; Moderate nausea; Fatigue; Muscle aches in injection arm; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), intramuscular in left arm, on 09Jan2021 at 17:30, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included ethinylestradiol/ ferrous fumarate/ norethisterone acetate (JUNEL FE). The patient previously took the first dose of BNT162B2 (Lot Number: EL0140) on 19Dec2020 (04:30 PM) for COVID-19 immunization (intramuscular in left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. The most recent vaccine was administered in a hospital facility. On 10Jan2021 at 05:30 AM (day 1 post-dose number 2), the patient experienced fever (highest at 101.8) twice, chills, moderate nausea, fatigue, and muscle aches in injection arm. No treatment was administered for the events. Post-vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,JUNEL FE,,,,,"['Chills', 'Fatigue', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,OT 976730,,,F,"contracted SARS-COV-2; contracted SARS-COV-2; This is a spontaneous report from a contactable physician (patient) via Medical Information. This physician reported similar events for two patients. This is the first of two reports. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received her first COVID-19 vaccination but contracted SARS-COV-2 from her husband, seven days after vaccination. Outcome of the events was unknown. Information about batch/lot number is requested.; Sender's Comments: Comirnaty's effectiveness is documented after at least seven days from the second vaccination.,Linked Report(s) : US-PFIZER INC-2021036192 same reporter/drug/events, different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 976731,NY,34.0,F,"I also did the home pregnancy test and I am pregnant; Tested positive for covid; Tested positive for covid; This is a spontaneous report from a contactable nurse (patient). This is a maternal report. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date was not provided), intramuscular via the left deltoid on 29Dec2020 11:15 at a single dose to prevent COVID. Medical history was none. There were no concomitant medications. It was reported that the patient received the Pfizer COVID vaccine on 29Dec2020 at 11:15am. She tested positive for COVID on 11Jan2021. She is supposed to be scheduled for her second dose on 19Jan2021. The patient asked the doctors and they don't know if she should get the second dose of the vaccine or postpone it. The patient called to ask if she should get the second dose. The patient took a home pregnancy test on 11Jan2021 and it came back positive, stated that this all occurred since she got vaccinated. Stated her last period was 13Dec2020. The patient reported that she is experiencing mild covid symptoms. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/11/2021,13.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Adverse event', 'Exposure during pregnancy', 'Inappropriate schedule of product administration', 'Pregnancy test positive', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 976732,PA,,F,"Mild arm soreness; fatigue; mild body aches; chills; received 1st dose of BNT162B2 on 29Dec2020, second dose received 12Jan2021; This is a spontaneous report from a contactable consumer. An adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiration date not reported) via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 on 29Dec2020 for COVID-19 immunization. The patient experienced mild arm soreness starting about 4 hours after the shot on 12Jan2021 and able to do subsequent work out. About 12 hours after vaccine, developed fatigue and mild body aches followed by about an hour of chills, which resolved. Took some ibuprofen and melatonin and slept well until 6 am. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,PVT,,,,,,"['Chills', 'Fatigue', 'Limb discomfort', 'Pain']",2,PFIZER\BIONTECH, 976733,NV,59.0,F,"swollen lymph nodes under arm of injection; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular in the right arm on 08Jan2021 10:45 at a single dose for COVID-19 immunization. The patient's medical history included allergies to penicillin and diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient previously took ciprofloxacin (CIPRO) and experienced allergies to ciprofloxacin. The patient had not been tested for COVID-19 since the vaccination. The patient experienced swollen lymph nodes under arm of injection on 11Jan2021 08:00. No treatment was received for the adverse event. Outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/11/2021,3.0,WRK,,,Medical History/Concurrent Conditions: COVID-19; Penicillin allergy,,,['Lymphadenopathy'],1,PFIZER\BIONTECH,OT 976734,,31.0,M,"Large rash around the injection site; This is a spontaneous report from a contactable physician (patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular (left arm) on 28Dec2020 19:00 at single dose for Covid-19 immunization. There was no medical history; no known allergies. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, the patient experienced large rash around the injection site which lasted 7 days. There was no treatment received for the adverse event. The outcome of event was recovered on 04Jan2021. The patient has not been tested for COVID-19 since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Injection site rash'],1,PFIZER\BIONTECH,OT 976735,MI,74.0,F,"fever; severe chills/could not get warm; her breathing was deep; drop in blood pressure; mild swelling/Swelling of Left Arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration in the left arm on 11Jan2021 10:00 at a single dose for COVID-19 vaccine (because she's 74 and high risk). Medical history included hypertension. Concomitant medication included irbesartan oral (by mouth) from an unspecified date (maybe 3 years ago) and ongoing at 300 mg once daily (150mg, 2 tablets once a day in the morning) for hypertension as blood pressure medication. The patient received the first dose of vaccine on Monday (11Jan2021) morning (AM) at 10 at the county (public) health department. She had no problem at all until yesterday Tuesday, she experienced mild swelling; the swelling happened in the upper left arm (swelling of left arm) which started on 12Jan2021, this was also the same side that she got her vaccine on, the left arm. On 13Jan2021 she woke up at 4AM [also reported as thirty (30) hours after the shot] in which she started to have severe chills (horrendous chills), could not get warm under the blanket for an hour and a half. It lasted a long time. Her severe chills did stop, she used an electric (heated) blanket. This morning on 13Jan2021 at 8:30, she woke up with the fever, which she was able to reduce with acetaminophen (did take two acetaminophen). Her fever was also gone. She was a little concerned because she thought her breathing was deep too on 13Jan2021. She did some relaxing breathing which helped. It lasted a long time. The patient also experienced a drop in blood pressure on 13Jan2021. Her blood pressure has been running the past few days at 133/80 on 11Jan2021. Today (13Jan2021), she took her blood pressure and it was at 93/50. It went to 87/56 after drinking some salty soup on 13Jan2021 (the bottom number in the blood pressure was going up a little, and the top number was going down a little). Her blood pressure has been normal 133/70 on Jan2021, but this morning it was 90/50 on 13Jan2021. Her blood pressure has been running normal the last couple of days like 133/90 on Jan2021. She was shocked it was lower. She knew they talk about dizziness and weakness, but she didn't experience that. She was concerned about that sudden drop in blood pressure. She did some research and started eating some salty soup and stuff (has been drinking salty soup). Her bottom number went up to 53 on Jan2021. She was concerned about that drop there. She was wondering if that was a side effect of the vaccine (result of the vaccine). She asked if drop in blood pressure was a concern. She had no positive test for Covid before the vaccine. She never had any tested, she's been pretty isolated. She had no antibody test. She has had no issues with vaccine in the past. Therapeutic measures were taken as a result of severe chills/could not get warm, fever, her breathing was deep, and drop in blood pressure. The outcome of swelling of left arm/mild swelling and drop in blood pressure was not recovered; of severe chills/could not get warm was recovered on 13Jan2021 05:30 and fever was recovered on 13Jan2021; and of her breathing was deep was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/12/2021,1.0,PUB,IRBESARTAN,,Medical History/Concurrent Conditions: Hypertension,,,"['Blood pressure decreased', 'Chills', 'Hyperventilation', 'Injection site swelling', 'No reaction on previous exposure to drug', 'Pyrexia']",1,PFIZER\BIONTECH, 976736,NY,51.0,M,"he had 102.1 temp; he started not feeling well; chills; ringing in ears/ The ringing was in both ears; body aches; joint aches; fatigue; lymphadenopathy/had swollen lymph nodes like the size of an apple; he was uncomfortable; His eyes were also hurting; The light bothered his eyes; This is a spontaneous report from a contactable Other HCP (patient) and a contactable Nurse (patient's wife). A 51-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/lot # EL3246, Expiry Date Apr2021) at single dose at left arm on 11Jan2021 18:00 for Covid-19 immunisation, administered at hospital as being a certified registered nurse anesthetist (CRNA). The patient medical history was none. There were no concomitant medications. The patient received the 1st dose of bnt162b2 (BNT162B2, lot # EK5730, expiry: 31Mar2021) at single dose at left arm on 23Dec2020 for Covid-19 immunisation and he has been fine, no adverse effect occurred. No additional vaccines administered on same date of BNT162B2. The patient experienced lymphadenopathy which is a size of tennis ball under my left armpit /had swollen lymph nodes like the size of an apple in his left arm in the axillary area, where he received the vaccine on 12Jan2021, he started not feeling well on 12Jan2021 around 9.00, he had 102.1 temp Fahrenheit on 12Jan2021 17:00, chills on 12Jan2021, ringing in ears/ the ringing was in both ears on 12Jan2021, body aches on 12Jan2021, joint aches on 12Jan2021, fatigue on 12Jan2021, his eyes were also hurting on an unspecified date in Jan2021, the light bothered his eyes on an unspecified date in Jan2021. The patient underwent lab tests and procedures which included body temperature: 102.1 fahrenheit on 12Jan2021, he was uncomfortable on 12Jan2021, body temperature: 100 and something fahrenheit on 13Jan2021. The outcome of lymphadenopathy/had swollen lymph nodes like the size of an apple was worsened, of he had 102.1 temp, ringing in ears/ the ringing was in both ears was not recovered, he started not feeling well, his eyes were also hurting, light bothered his eyes was unknown, chills, body aches, joint aches, fatigue was recovered on 13Jan2021. Course of events: Around 9AM on 12Jan2021 he started not feeling well. By the time he got home from work he had 102.1 temp Fahrenheit around 5PM. Temp was ongoing. His eyes were also hurting. The light bothered his eyes. He can't put his arm down. His left arm in the axillary area, where he received the vaccine, had swollen lymph nodes like the size of an apple. He had chills, ringing in ears, body aches and joint aches, and fatigue 12Jan2021. He was uncomfortable. The ringing was in both ears. On 13Jan2021 his temp was one hundred and something. What is concerning was the swelling in the armpit in the arm he received the vaccine in. It was very painful. It was starting to radiate up his arm. He did not go to the doctor, since he was relatively healthy. No event required a visit to Emergency Room or Physician Office. The reporting Nurse assessed the events he had 102.1 temp, His left arm in the axillary area, where he received the vaccine, had swollen lymph nodes like the size of an apple as serious as medically significant. The reporting Nurse assessed the events he had 102.1 temp, His left arm in the axillary area, where he received the vaccine, had swollen lymph nodes like the size of an apple, chills, Ringing in ears, body aches and joint aches, and Fatigue as related to BNT162B2.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between events lymphadenopathy and fever and BNT162B2 COVID-19 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/01/2021,,PVT,,,,,,"['Arthralgia', 'Body temperature increased', 'Chills', 'Discomfort', 'Eye pain', 'Fatigue', 'Injected limb mobility decreased', 'Lymphadenopathy', 'Malaise', 'Pain', 'Pain in extremity', 'Photophobia', 'Tinnitus']",2,PFIZER\BIONTECH, 976739,NC,31.0,F,"Severe rigors involving core and extremities, making it difficult to breathe.; Severe rigors involving core and extremities, making it difficult to breathe.; muscle pain; joint pain noted in hips; loss of appetite; profound fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231, expiry: unknown), via an unspecified route of administration on 11Jan2021 11:45 on the left arm at a single dose for COVID-19 immunization. The patient received the vaccine in a hospital. The patient had no other vaccine in four weeks. Medical history included clinical depression. The patient has no known allergies. The patient was not tested for COVID prior and post vaccination. Concomitant medications included bupropion and multivitamin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK5730, expiry: unknown) on 21Dec2020 at 11:00 in the right arm for COVID-19 immunization. On 12Jan2021 at 01:00, the patient experienced severe rigors involving core and extremities, making it difficult to breathe. Flexeril 10 mg was taken to help relieve rigors. Rigors stopped and ease of breathing resumed in 1 hour. Other symptoms include muscle pain, joint pain noted in hips, loss of appetite, and profound fatigue x48 hrs. The events difficult breathing, muscle pain, joint pain noted in hips, loss of appetite and profound fatigue were not treated. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of ""severe rigors involving core and extremities, making it difficult to breathe"". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/12/2021,1.0,PVT,BUPROPION,,Medical History/Concurrent Conditions: Clinical depression,,,"['Arthralgia', 'Chills', 'Decreased appetite', 'Dyspnoea', 'Fatigue', 'Myalgia']",2,PFIZER\BIONTECH, 976741,,,M,"He mentioned that he took the first dose of the COVID-19 vaccine on 29Dec2020. Then, after a few days, tested positive for COVID-19.; He mentioned that he took the first dose of the COVID-19 vaccine on 29Dec2020. Then, after a few days, tested positive for COVID-19.; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable nurse (patient) reported that a male patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He mentioned that he took the first dose of the COVID-19 vaccine on 29Dec2020. Then, after a few days, tested positive for COVID-19. He is scheduled for his second dose this weekend (16Jan2021-17Jan2021). He wants more information about his safety. What happens next, the do's and don'ts. He is asking if there is any information on this. The outcome of the event was unknown. Information about the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/31/2020,2.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 976744,,,F,"tested positive COVID-19; tested positive COVID-19; This is a spontaneous report from a contactable healthcare professional, reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received first dose of the COVID-19 vaccine on 28Dec2020, 9 days later tested positive COVID-19. She requested information on the recommendations for getting her second dose of the vaccine. The patient underwent lab tests and procedures which included Covid test: positive on Jan2021. The outcome of the events was unknown. Information on the batch/lot number has been requested.; Sender's Comments: Comirnaty's effectiveness is documented after 7 days from the second dose",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/01/2021,4.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 976746,,,M,"7 days later tested positive for the COVID-19 infection; 7 days later tested positive for the COVID-19 infection; This is a spontaneous report from a contactable consumer (patient's mother). A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's mother was asking in regards of her son who received first dose of the COVID-19 vaccine and 7 days later tested positive for the COVID-19 infection, she wants to know if the patient could receive the second dose, is been 14 days since he tested positive with the PCR test. Patient is not showing any symptoms. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 976757,,,F,"first dose of the COVID-19 vaccine on 23Dec2020, and testing positive to COVID on 01Jan2021; first dose of the COVID-19 vaccine on 23Dec2020, and testing positive to COVID on 01Jan2021; This is a spontaneous report from a non-contactable Other HCP. A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the first dose of the COVID-19 vaccine on 23Dec2020, and testing positive to COVID on 01Jan2021. She mentioned that her ""last recorded symptoms"" were on 06Jan2021 and has been ""symptom less"" for 8 days, now. She specified that her second dose was due today but she didn't receive it at her workplace, as planned (due to isolation measures). She asked what was the allowed window to receive the second dose of the vaccine? She also asked what were the criteria to receive the second dose, after testing positive. She then asked if she would need to repeat the vaccination series. Patient also mentioned testing positive to COVID on 13Jan2021. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given. However, a causal relationship between event ""first dose of the COVID-19 vaccine on 23Dec2020, and testing positive to COVID on 01Jan2021"" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/01/2021,9.0,UNK,,,,,,"['Adverse event', 'Inappropriate schedule of product administration', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 976758,CA,60.0,F,"like an anaphylactic reaction but not in her throat; itching and inflammation, in eyes as well/eyes were swollen and itchy; itching and inflammation, in eyes as well; swelling on her eyes and itching on her eye lids; swelling on her eyes and itching on her eye lids; welts; whelps on her hip, inflamed and itchy/general arthritis symptoms; Headache dull; shingle like rash on tailbone, genital area / raised itchy rash on the tailbone like shingles; itching on her face that she couldn't see / raised itchy area on her left cheek and eyes; rash / rash down her thighs/rash that was across her body; rash vulva; swelling / vulva was swollen; itching / itching around the genital area, vulva; itching / itching around the genital area, vulva; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse (patient) worked in outpatient mental health reported that a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, Expiry Date: Apr2021) via an unspecified route of administration on 04Jan2021 at 16:20 in the left arm at single dose for COVID-19 vaccination. Vaccine administered at hospital and not military facility. No additional vaccines administered on same date of the Pfizer suspect. Medical history included ongoing Graves' disease (the patient had her thyroid irradiated away for Grave's disease 25 years ago). Family Medical History was none. Concomitant medication included ongoing levothyroxine 1.25 mcg once daily by mouth Graves' disease taking for 25 years. Prior vaccination within 4 weeks was none. The patient received her Pfizer COVID 19 vaccine on 04Jan2021. Since then she started to experience a genital itch immediately; a rash that was across her body; eyes were swollen and itchy; new itchy rash 13Jan2021. She felt okay going home then she started to have itching around the genital area. She thought she might have a yeast infection but she didn't have any other symptoms for a yeast infection. Her vulva became swollen from 05Jan2021 and itchy from 04Jan2021 and she noticed rash around her body. It all started in the genital area. The next day the rash spread down her thighs and she noticed an itchy place on her face, but you couldn't see it. Her thighs were inflamed and she noticed patches of angry whelps on her hips as well as a itchy rash area on her tailbone that seemed more like shingles; size of a quarter; raised, itchy, rash, that felt like it was radiating out. Then she noticed the rash on her face on her cheek, general swelling on her eyes and itching on her eye lids. Now the genital itching was less and most of her symptoms were improved but her eye was driving her crazy and it was more swollen on the outside. She tried to treat her eyes with eye drops Dry Eye Relief (manufacturer Similasan; no UPC seen, lot number: 15942; expiration date: Sep2022, ingredients include Belladonna) but it didn't help. They were still itchy and weepy. The eye drops were not working. She also treated the rash and itching with Benadryl at night and it improved the symptoms overall. She took Tylenol (UPC 300043760; lot number: PMA003; expiration date: Aug2022) and Bayer Aspirin (81mg; lot number: NAA93E1; expiration date: Feb2023. No UPC code on bottle) every day for general arthritis symptoms, but they didn't touch her dull headache she has had on and off since the vaccine. Before she got the vaccine, she had a little tag on her vulva, it was tiny. Now after experiencing the itching, swelling, rash on her vulva, the tag was gone. It just took a layer of skin right off. It was not uncomfortable but the whole layer of the skin was gone. It was very uncomfortable while it was happening but now it was okay. When she noticed these symptoms, she tried to call occupational health and a institute but didn't get anyone. She also contacted her HCP but had not heard back. It seemed to her like a lot of side effects and a lot of itching. She didn't have it in her throat, but all that itching seems a lot like an anaphylactic reaction. She was curious whether we would recommend her to take the second dose since they say the reaction to the second dose was worse. She had multiple COVID tests that have all come back negative. A friend tested positive so she had a test; and she had a test when she traveled. The events did not require a visit to physician or emergency room. The patient had reactions: itching, rash, swelling, welts, shingle like rash on tailbone, genital area, hips moving to her face, itching and inflammation, in eyes as well. She wanted to know if the 2nd dose was recommended. It was ""like an anaphylactic reaction but not in her throat."" itching around the genital area, vulva started from 04Jan2021, vulva was swollen started from 05Jan2021; Rash vulva started from 06Jan2021 to 10Jan2021; rash down her thighs started from 07Jan2021; Raised itchy rash on the tailbone like shingles started from 06Jan2021, whelps on her hip, inflamed and itchy from 07Jan2021; itching on her face that she couldn't see started from 06Jan2021; raised itchy area on her left cheek and eyes started from 07Jan2021; Headache dull started from 06Jan2021. The events Headache dull, itching on her face that she couldn't see; whelps on her hip, inflamed and itchy and raised itchy rash on the tailbone like shingles were reported as non-serious by the reporter and other events were considered as medical significant by the reporter. Investigation assessment for the events was reported as No. The outcome of the event anaphylactic reaction, inflammation in eye, welts was unknown, outcome of the event Rash vulva was recovered on 10Jan2021; of Headache dull, swelling eye was not recovered, of other events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,LEVOTHYROXINE,Graves' disease (Had her thyroid irradiated away for Grave's disease 25 years ago),,,,"['Eye pruritus', 'Eye swelling', 'Eyelids pruritus', 'Genital rash', 'Headache', 'Immediate post-injection reaction', 'Inflammation', 'Lacrimation increased', 'Periorbital swelling', 'Pruritus', 'Pruritus genital', 'Rash', 'Rash papular', 'Rash pruritic', 'Rash vesicular', 'SARS-CoV-2 test negative', 'Skin exfoliation', 'Urticaria', 'Vulvovaginal pruritus', 'Vulvovaginal rash', 'Vulvovaginal swelling']",1,PFIZER\BIONTECH, 976763,IN,29.0,F,"2 weeks after covid 19 vaccine, had severe multiple allergic reactions never experienced.; Suture reaction to surgical site; allergic flare up of previously healed and closed nerve block locations; slight increase in eosinophils, CRP; slight increase in eosinophils, CRP; increase in platelets; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number Ek5t30), intramuscularly on 20Dec2020 12:00 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant. The facility type vaccine was workplace clinic. Medical history included hypothyroidism from an unknown date. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. 2 weeks after COVID-19 vaccine on 01Jan2021 21:00, patient had severe multiple allergic reactions never experienced. Suture reaction to surgical site, allergic flare up of previously healed and closed nerve block locations, then later apparent full body reaction to Bactrim. At least 3 allergic reactions never experienced before with slight increase in eosinophils, CRP, and increase in platelets. Severe Suture rejection to extremely common sutures. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization one day. Patient received IV methylprednisone, Benadryl, famotidine as treatment for the adverse events. The outcome of events was recovered in Jan2021. Known allergies included apparent Bactrim allergy, in spite of allergic symptoms starting 4 days prior to taking Bactrim.; Sender's Comments: Based on the information currently provided, the vaccination might trigger the onset of multiple allergic reactions accompanying with lab abnormalities, considering the plausible temporal relationship. Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/20/2020,01/01/2021,12.0,WRK,,,Medical History/Concurrent Conditions: Hypothyroidism,,,"['Allergy to surgical sutures', 'C-reactive protein increased', 'Dermatitis allergic', 'Drug hypersensitivity', 'Eosinophil count increased', 'Multiple allergies', 'Platelet count increased']",1,PFIZER\BIONTECH,OT 976767,MO,44.0,F,"I had acute onset Mononeuropathy of the R posterior interosseous nerve; This is a spontaneous report from a contactable physician (patient herself). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular on 07Jan2021 at 16:30, at a single dose, for COVID-19 immunization. The patient has no relevant medical history, has no known allergies, and has no concomitant medications. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) on 17Dec2020 at 12:00, for COVID-19 immunization. The patient stated that 48 hours after administration, on 09Jan2021 at 15:00, she had an acute onset mononeuropathy of the right (R) posterior interosseous nerve. Patient stated this may be unrelated and she wanted to know if this is a trend. She was seen by neuro, she had electromyogram (EMG) and magnetic resonance imaging (MRI) and it was definitely an isolated nerve. The event was treated with prednisone. Outcome of the event was recovering. The patient has not been tested for COVID-19 since vaccination.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of mononeuropathy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,PVT,,,,,,"['Electromyogram abnormal', 'Magnetic resonance imaging abnormal', 'Mononeuropathy']",2,PFIZER\BIONTECH,OT 976771,FL,59.0,F,"Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest pain; Right calf pain/cramping; Right calf pain/cramping; Fever; Chill; Body aches; Severe headache; Left arm swelling; left arm swelling, redness, knot; left arm swelling, redness, knot; Pain at injection site; Fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 11Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 (COVID prior vaccination: Yes) and known allergies to penicillin and erythromycin. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 07:15, for COVID-19 immunization. The patient experienced shortness of breath w/min exertion, right calf pain/cramping, fever, chill, body aches, severe headache, left arm swelling, redness, knot and pain at injection site, dull chest pain, fatigue, throat tightness/numbness on 11Jan2021. The events resulted to emergency room/department or urgent care visit. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: The 59-year-old patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021, and experienced shortness of breath w/min exertion, dull chest pain, throat tightness/numbness and other symptoms on the same day. Considering plausible temporal relationship, the events were probably related to the second dose of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,PVT,,,Medical History/Concurrent Conditions: COVID-19 (If covid prior vaccination: Yes); Penicillin allergy,,,"['Chest pain', 'Chills', 'Dyspnoea', 'Erythema', 'Fatigue', 'Headache', 'Injection site nodule', 'Injection site pain', 'Muscle spasms', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pharyngeal hypoaesthesia', 'Pyrexia', 'Throat tightness']",2,PFIZER\BIONTECH,OT 976773,,,F,"She received 1st dose of Covid vaccine and then tested positive for Covid.; She received 1st dose of Covid vaccine and then tested positive for Covid.; This is a spontaneous report from a contactable other health professional from a Pfizer-sponsored program Pfizer First Connect. A female elderly patient (Grandmother, 80 or older) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received 1st dose of covid vaccine and then tested positive for covid on 12Jan2021. The patient underwent lab tests and procedures which included Covid: positive on 12Jan2021. The reporter's grandmother (female, caller stated age is 80 or older) received the vaccine 3 weeks ago and was scheduled to get the vaccine tomorrow but tested positive for covid on 12Jan2021. The reporter was wondering whether she could get the 2nd dose in this case. She's asymptomatic, not sure when she came down with it. She resided in a Senior care facility. They would have (Pharmacy name) coming tomorrow to get the vaccine. They stated she won't be getting it. The reporter was asked whether it would lose effectiveness if wait and whether the efficacy would go down If wait longer to get the 2nd dose. The outcome of events was unknown. Information on the batch number and lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/12/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 976776,WA,45.0,F,"intermittent dizziness; felt a ""closing in"" sensation/brain fog; pulse and blood pressure went up; pulse and blood pressure went up; severe headache; hot flushing; chest tightness; started getting pale; sweating; peripheral perfusion worsened; palpitations; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), intramuscular in left arm on 31Dec2020 at 08:15 AM at a single dose for COVID-19 immunization in a workplace clinic. Medical history included mild asthma and known allergies to bee stings. There were no concomitant medications. Within a few minutes of the vaccine on 31Dec2020, the patient felt a ""closing in"" sensation and then her pulse and blood pressure went up. She developed a severe headache and hot flushing with chest tightness. The medical team gave her epinephrine in right thigh and she felt a bit better. Then she started getting pale, sweating, and peripheral perfusion worsened so she was given a second dose of epi. She started feeling better, but had a headache, palpitations and ""brain fog"" for about 5 days after and she still having intermittent dizziness (unspecified date). The patient received epinephrine IM and benadryl IV push for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient recovered from the events with lasting effects. The patient had not yet recovered from the event dizziness, while the patient recovered with sequelae for the remaining events. Information on the lot/batch number has been requested.; Sender's Comments: The reported events were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,,,Medical History/Concurrent Conditions: Asthma; Bee sting hypersensitivity,,,"['Blood pressure increased', 'Chest discomfort', 'Dizziness', 'Feeling abnormal', 'Headache', 'Heart rate increased', 'Hot flush', 'Hyperhidrosis', 'Pallor', 'Palpitations', 'Poor peripheral circulation']",1,PFIZER\BIONTECH,OT 976777,MD,55.0,F,"severe incapacitating headache starting several hours after vaccine and lasting at least through today 13Jan2021. Steroids prescribed today; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 09Jan2021 11:30 at single dose for covid-19 immunisation. The patient's medical history included Asthma and hypertension. The patient's concomitant medication includes unspecified medication. On 09Jan2021 23:00, the patient experienced severe incapacitating headache starting several hours after vaccine and lasting at least through today 13Jan2021. The patient event resulted in doctor or other healthcare professional office/clinic visit and Steroids prescribed today. Treatment includes prednisone. The outcome of the event was unknown.; Sender's Comments: Based on the compatible time association and drug's safety profile, the event headache is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/09/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Asthma; Hypertension,,,['Headache'],1,PFIZER\BIONTECH, 976778,NJ,42.0,F,"heart started to race; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; heart rate jumped to 160; heart rate jumped to 160 and blood pressure went up; choking sensation on her neck; This is a spontaneous report from a contactable healthcare professional. A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date), dose number 2 via an unspecified route of administration on 12Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history was not reported. The patient did not have COVID prior vaccination. The patient previously took nitroglycerin and experienced drug allergy. Historical vaccine included BNT162B2 (lot number EL0140, dose number 1) for immunization on 22Dec2020 after which the patient experienced mild headache. Concomitant medications were not reported. There were no other vaccines received within 4 weeks. The patient had no adverse reaction other than mild headache after the first dose, so she was very relaxed and she felt comfortable getting the 2nd dose. However, after 10 minutes after the second dose, her heart started to race and she started to feel a tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed. Her heart rate jumped to 160 and her blood pressure went up. She couldn't even open her eyes nor speak a word. She was transported to the ER and was given steroids and anti-histamine. She refused to get an epinephrine shot at first, but she started to feel choking sensation on her neck so she asked for an epi shot. The patient had not been tested for COVID post-vaccination. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events heart racing, tingling sensation, paralyzed, heart rate high, blood pressure increased and chocking sensation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,PVT,,,,,,"['Blood pressure increased', 'Choking sensation', 'Eyelid function disorder', 'Heart rate increased', 'Palpitations', 'Paraesthesia', 'Paralysis', 'Speech disorder']",2,PFIZER\BIONTECH, 976781,GA,53.0,F,"elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbness and tingling in both hands; nausea; rash across the top of my chest; sore muscles in legs; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via intramuscular route of administration in the left arm, on 12Jan2021 10:30 at SINGLE DOSE for covid-19 immunization. Medical history included asthma, sinusitis and migraine. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), albuterol, estradiol, norethisterone acetate (ESTRADIOL AND NORETHINDRONE), vitamin d3, zinc, paracetamol (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). The patient previously took erythromycin, levaquin, biaxin and cefzil (on unspecified dates) and experienced allergy. The patient started having reactions after 20 mins (12Jan2021, 10:45am): a bad headache, elevated BP: 193/113 (no history of hypertension), tachycardia 134 BPM, numbness and tingling in both hands, nausea, and a rash across the top of the chest. Since it was administered in a workplace drive-thru clinic, there was a 15-30 mins post vaccine monitoring. She was taken inside for further evaluation and monitoring with no changes after 30 mins. EMS was called for transport to the closet hospital that wasn't on diversion. Her allergist was consulted by the treating ER physician and was later discharged with prescriptions for the following: Epipen, prednisone for 5 days, and pepcid. Follow-up with allergist in 3-5 days and PCP. Patient was still recovering however headache was and sore muscles in legs were still present. The outcome of events headache was and sore muscles in legs was not recovered whereas patient was recovering from all other events. Therapeutic measures taken as result of the events included Benadryl, Pepcid, Zofran, Tylenol, 1L Saline bolus, EKG, lab work, monitoring on a pulse ox, frequent BP. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,WRK,ADVAIR; ALBUTEROL [SALBUTAMOL]; ESTRADIOL AND NORETHINDRONE; VITAMIN D3; ZINC; TYLENOL; BENADRYL,,Medical History/Concurrent Conditions: Asthma; Migraine; Sinusitis,,,"['Blood pressure increased', 'Electrocardiogram', 'Headache', 'Hypoaesthesia', 'Laboratory test', 'Myalgia', 'Nausea', 'Paraesthesia', 'Rash', 'Tachycardia']",1,PFIZER\BIONTECH,OT 976782,WI,,F,"rash and itchiness on face and chest; rash and itchiness on face and chest; anxiety; feeling restless/shakiness; insomnia; difficulty concentrating; feeling restless/shakiness; she developed sudden chest tightness; throat hoarseness; scratchiness; lightheadedness; This is a spontaneous report from a contactable pharmacist. An adult female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 31Dec2020 10:45 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Approximately 5 minutes later on 31Dec2020 10:50, she developed sudden chest tightness, throat hoarseness and scratchiness, and lightheadedness. Staff responded with AED and rescue meds, called for EMS transport to ED. Employee reported that at ED , the patient was treated with rescue medications including Benadryl, Pepcid, solumedrol, but symptoms continued to worsen, therefore epi was given which improved symptoms. The patient was observed in ED for approximately 6 hours before being discharged home with oral antihistamines, steroid pack, and an epi-pen. Once home, employee experienced a rash and itchiness on face and chest which has now resolved. Patient was still experiencing side effects from medications including insomnia, anxiety, difficulty concentrating, and feeling restless/shakiness. The outcome of the events sudden chest tightness, throat hoarseness and scratchiness, and lightheadedness was recovering; the outcome of the events rash and itching was recovered on an unknown date; while the outcome of the remaining events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on a close chronological association, a causal relationship between events chest tightness, throat hoarseness and scratchiness, and lightheadedness occurred approx. 5 minutes after vaccination and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,WRK,,,,,,"['Chest discomfort', 'Dizziness', 'Dysphonia', 'Pruritus', 'Rash', 'Throat irritation']",1,PFIZER\BIONTECH, 976786,MI,38.0,F,"hot flash; arm was very sore at the injection site; diagnosed with an allergic reaction; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 38-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand= Pfizer/Biontech, lot/batch number and expiry date were not reported), via an unspecified route of administration in the right arm on 11Jan2021 14:45 at SINGLE DOSE for Covid-19 vaccination. She received the vaccine in a facility. Medical history included gastrooesophageal reflux disease. No other vaccine in four weeks. Concomitant medications included ergocalciferol (VIT D) and lansoprazole (PREVACID). On 11Jan2021, within about 10 minutes of getting the vaccine she reported that her heart began to race and she became sweaty and uncomfortable. After another 5 minutes or so she began to have difficulty breathing as her chest and throat felt very tight and restricted. She also became lightheaded. Her heart rate was over 100, then dropped into the 70s, then shot back up over 100. Her face had a weird sensation as well. She was given Benadryl first and then epinephrine and had to go to the emergency room via ambulance for observation. She was released after an hour and had to take Benadryl every 6 hours for the next 24 hrs and diagnosed with an allergic reaction. On 12Jan2021, she had a hot flash upon waking up and felt generally under the weather all day. Her arm was very sore at the injection site. She missed a day of work due to the whole ordeal. On 13Jan2021, she felt more normal but still have some tightness in her chest with a fluttering feeling. The outcome of event diagnosed with an allergic reaction was not recovered; for other events was recovered. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between event allergic reaction to vaccine and BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,PUB,VIT D; PREVACID,,Medical History/Concurrent Conditions: GERD,,,"['Cardiac flutter', 'Chest discomfort', 'Discomfort', 'Dizziness', 'Dyspnoea', 'Hot flush', 'Hyperhidrosis', 'Hypersensitivity', 'Impaired work ability', 'Injection site pain', 'Malaise', 'Palpitations', 'Sensory disturbance', 'Throat tightness']",1,PFIZER\BIONTECH, 976796,,,F,"shakes; difficulty walking; This is a spontaneous report from a non-contactable consumer (patient). This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. It was unknown if the patient received other vaccines in four weeks. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced shakes and difficulty walking. The reported events resulted in Doctor or other healthcare professional office/clinic visit and hospitalization on an unspecified date. It was unknown if the patient had COVID-19 prior to vaccination and it was unknown if she was tested for COVID-19 post vaccination. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,"['Gait disturbance', 'Tremor']",UNK,PFIZER\BIONTECH, 976799,FL,55.0,F,"dizzy; cold chills/chills; a little headache; nausea/nauseated/nauseous; vomiting/ vomited; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiration date: Apr2021) via an unspecified route of administration on left deltoid on 12Jan2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. The patient stated she had a shingles vaccine, got dizzy and nauseous, thought this was about 3 years prior to the report. The patient received the first dose of the vaccine after working a night shift. She went home, went to bed and then woke up very dizzy, nauseated, vomited and experienced cold chills on and off. She also stated that about 10 hours after she got the shot, she got dizzy, nauseous, threw up a couple of times, got chills, and had a little headache on 12Jan2021. She stated she was a little nervous about getting the second vaccine. She also worked nights and that she got off her night shift and got the vaccine on 12Jan2021, didn't know if maybe she was a little dehydrated possibly. The events are reported as serious due to medically significant. The outcome of the events nausea/nauseated/nauseous and vomiting/ vomited was recovered on 13Jan2021, for the events dizzy, cold chills/chills and a little headache were recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Dizziness', 'Headache', 'Nausea', 'Nervousness', 'Vomiting']",1,PFIZER\BIONTECH, 976810,IL,31.0,F,"one syncopal episode; Shaking chills; light headed; pregnant female patient received the vaccine; pregnant female patient received the vaccine; pregnant female patient received the vaccine; This is a spontaneous report from a contactable healthcare professional (patient). This healthcare professional only reported information for the mother (herself). This is the maternal case. A 31-year-old pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the left arm, on 11Jan2021 at 08:15 (at the age of 31-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient's last menstrual period was 05Dec2020 and the patient was pregnant at the time of vaccination (5 gestation weeks) with a due date of 11Sep2021. Concomitant medications, taken within two weeks of vaccination, included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ1685) on 21Dec2020 at 09:00 (at the age of 31-years-old) for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced shaking chills, light headed, and one syncopal episode on 12Jan2021 at 01:00. The pregnant female patient received the vaccine on 11Jan2021 at 08:15. The patient did not receive any treatment for the events. The clinical outcome of shaking chills, light headed, and one syncopal episode was recovered in Jan2021 and of pregnant female patient received the vaccine was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the close temporal relationship, the association between the event syncopal episode with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS,,,,,"['Chills', 'Dizziness', 'Exposure during pregnancy', 'Syncope']",2,PFIZER\BIONTECH, 976812,PA,26.0,F,"syncope; Fever; Joint pain; Weakness; Dizziness; Tachycardia; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EL3302 via an unspecified route of administration in left arm, on 12Jan2021 17:00 at single dose for covid-19 immunisation. Previously the patient received the first dose of BNT162B2 on 22Dec2020 at 17:00, lot number EJ1685, in left arm, for covid-19 immunisation. The vaccine was administered at Hospital Facility. No other vaccine was administered in four weeks. No COVID prior vaccination. COVID was not tested post vaccination. No known allergies. Medical history included asthma and postural orthostatic tachycardia syndrome, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 12Jan2021 the patient experienced syncope, fever, joint pain, weakness, dizziness, tachycardia, fatigue. The events required Physician Office visit. The patient was not treated for the events. The outcome of the events was resolving.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Asthma; Postural orthostatic tachycardia syndrome,,,"['Arthralgia', 'Asthenia', 'Dizziness', 'Fatigue', 'Pyrexia', 'Syncope', 'Tachycardia']",2,PFIZER\BIONTECH, 976814,NY,,F,"loss of consciousness; Chest tightness; shortness of breath; fatigue; This is a spontaneous report from a contactable healthcare professional. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as a first single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced loss of consciousness, chest tightness, shortness of breath and fatigue on an unspecified date with outcome of unknown. The reporter indicated that these severe reactions occurred after the first vaccination with BNT162B2. The outcome of loss of consciousness, chest tightness, shortness of breath and fatigue was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event loss of consciousness cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Chest discomfort', 'Dyspnoea', 'Fatigue', 'Loss of consciousness']",UNK,PFIZER\BIONTECH, 976836,MI,41.0,F,"seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss of hearing; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; loss of the onion ability to stand up or walk; loss of the onion ability to stand up or walk; This is a spontaneous report from a contactable other health professional (patient), a 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm on 14Jan2021 08:30 AM at single dose for covid-19 immunization in a public health facility. Medical history was none. Allergies to medications, food, or other products was No. Patient was not pregnant at the time of vaccination. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. the patient received within 2 weeks of vaccination included amphetamine salts 15 mg. Patient woke up in the middle of the night got out of bed walk down a set of stairs started seeing gray spots room started spinning felt nauseous collapsed on the table. Had to call her husband to carry her back up the stairs. she had loss of vision loss of hearing and the onion ability to stand up or walk. He laid her back in bed to pick up his phone and call emergency services within five minutes everything had gone back to normal. adverse event start date was 15Jan2021 03:00 AM. the adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The final outcome of the events was unknown (if patient recovered: Unknown). It was reported as non-serious. Seriousness criteria Results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all no.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/15/2021,1.0,PUB,AMPHETAMINE SALTS,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Blindness', 'Deafness', 'Dysstasia', 'Gait disturbance', 'Nausea', 'Syncope', 'Vertigo', 'Visual impairment']",1,PFIZER\BIONTECH, 976841,,,M,"her husband received the Covid vaccine last Friday and was positive for Covid 19; positive for Covid 19; This is a spontaneous report from a non-contactable consumer reporting for herself and her husband. This case is for the reporter's husband. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not reported) via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 08Jan2021 (Friday) and was positive for COVID-19 on 11Jan2021 (Monday). The outcome of the event was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021024045 same reporter/product/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/11/2021,3.0,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 976851,PA,39.0,F,"L Axillary lymphadenopathy; Fever 102.8 (H); muscle aches/heaviness; Migraine; Tachycardia; Chest pressure/pain; Chest pressure/pain; elevated BP; malaise; This is a spontaneous report from a contactable 39-year-old female Nurse reported for herself. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number E10140), intramuscular in arm left on 11Jan2021 12:30 at single dose for COVID-19 immunization. Medical history included Low BP, depression, insomnia, latex allergy. The patient was allergy to morphine and diltiazem (CARDIZEM). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, E10140) on 24Dec2020 10:45 AM, intramuscular in left arm at age of 39 years old for Covid-19 immunization. Concomitant medication included cefixime (FLEXERIL), diphenhydramine hydrochloride (UNISOM), acetylsalicylic acid (ASPIRIN) and ibuprofen. The patient experienced l axillary lymphadenopathy, fever 102.8, muscle aches/heaviness, migraine, tachycardia, chest pressure/pain, elevated bp, malaise, all on 11Jan2021 23:00 with outcome of recovered with sequelae. The patient underwent lab tests and procedures which included blood pressure: elevated on 11Jan2021, body temperature: 102.8 on 11Jan2021 (H), nasal swab: negative on 12Jan2021 (Covid test post vaccination). The events were non-serious, result in emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient received Bolus of IV (intravenous) fluids for treatment.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,PVT,FLEXERIL; UNISOM; ASPIRIN; IBUPROFEN,,Medical History/Concurrent Conditions: Depression; Insomnia; Latex allergy; Low BP,,,"['Blood pressure increased', 'Chest discomfort', 'Chest pain', 'Discomfort', 'Lymphadenopathy', 'Malaise', 'Migraine', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tachycardia']",2,PFIZER\BIONTECH,OT 976854,MA,68.0,M,"tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist (patient). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 28Dec2020 at 18:00 at a single dose for COVID-19 immunization. Medical history included diabetic and blood pressure high, both from 10-15 years. There were no concomitant medications. The patient does nursing homes and assisted living facilities and also the employees of the nursing home. The patient received the first dose of COVID-19 vaccine on 28Dec2020 at 1800 PM in the left arm. He tested negative on 27Dec2020, 04Jan2021, and 08Jan2021 and tested positive for COVID-19 on 11Jan2021, which was 2 weeks after the administration of the vaccine. He reported no severe symptoms, all he got from the COVID-19 infection was a little bit of chills, temperatures rising to a maximum of 100 degrees Fahrenheit (temperature back and forth), body aches, oxygen levels at 95%, and no cough. His oxygen saturation has always been good between 95% and 96%. The patient asked what caused the positive test and asked if he was going to have protection after receiving the first dose of COVID vaccine. The patient is due for the second dose of the COVID vaccine on Monday, the 18th (18Jan2021), in which he will still be under isolation. The patient asked if he should wait until he gets out of isolation to receive the second vaccine. The patient asked if that is part of the vaccine to test positive for COVID or if he actually does have COVID. The patient also asked if he can have the second dose. He will be unable to receive second dose of the COVID vaccine at the 21-day mark due to being in isolation from the COVID virus. The patient was recovering from the events. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/11/2021,14.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure high (from 10-15 years); Diabetic (from 10-15 years),,,"['Body temperature increased', 'COVID-19', 'Chills', 'Inappropriate schedule of product administration', 'Pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 976858,OH,,U,"contracted covid after receiving the 1st vaccine dose; contracted covid after receiving the 1st vaccine dose; This is Spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 3rd of 6 reports. A patient of unspecified age and gender received the first dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient contracted COVID after receiving the 1st vaccine dose on an unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.,Linked Report(s) : US-PFIZER INC-2021035078 same reporter/product/event, different patient;US-PFIZER INC-2021035069 Same reporter/drug, different patient/ event",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,SEN,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 976859,OH,,U,"COVID; COVID; This is spontaneous report from a contactable Nurse. This Nurse reported similar events for 6 patients. This is 5th of six reports. An unknown age and gender patient received 1st of BTN162B2 (Pfizer BioNTech Covid 19 vaccine) on 22Dec2020 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. it was reported that patient contracted COVID after receiving the 1st vaccine dose. Outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient, who contracted COVID after receiving the 1st vaccine dose, cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,SEN,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 976864,NC,46.0,F,"tunnel vision; 2 minutes after injection Heart rate went to 138/Hr 110/elevated heart rate.; dizziness; This is a spontaneous report from a contactable nurse reporting for herself. A 46-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number Ek9231, via an unspecified route of administration in left arm on 28Dec2020 at 11:45, at 46 years of age, at single dose for COVID-19 immunization. The patient was not pregnant when she was vaccinated and received the vaccine in Hospital. She didn't receive any other vaccine in the previous 4 weeks. Medical history included Meniere's disease with sudden hearing loss in left ear from an unknown date, gastrooesophageal reflux disease from an unknown date and allergy to penicillin and sulfa drugs. Concomitant medication included famotidine (PEPCID), paracetamol (TYLENOL), ergocalciferol (VITAMIN D) supplements and cetirizine hydrochloride (ZYRTEC). On 28Dec2020, 2 minutes after vaccine injection, the patient experienced tunnel vision, assessed as medically significant, her heart rate went to 138 and she experienced dizziness. The same happened again ""at the 8 min mark"": heart rate at 110 and dizziness. The events resolved on their own. Dizziness and elevated heart rate happened again later that evening. At the time of the report the reported events had resolved without any treatment.; Sender's Comments: Based on the compatible time association, the events tunnel vision, heart rate increased and dizziness are reasonably related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,PEPCID; TYLENOL; VIT D; ZYRTEC,,Medical History/Concurrent Conditions: Acid reflux (esophageal); Hearing loss; Meniere's disease (Menieres with sudden hearing loss left ear.); Penicillin allergy; Sulfonamide allergy,,,"['Dizziness', 'Heart rate increased', 'Tunnel vision']",1,PFIZER\BIONTECH, 976865,NY,,F,"bell's palsy from covid vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose on Jan2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Jan2021 the patient experienced bell's palsy from COVID-19 vaccine. The event resulted in doctor office/clinic visit, disability or permanent damage. Since the vaccination, the patient has not been tested for COVID-19. At the time of reporting the outcome of the event was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/01/2021,01/01/2021,0.0,PVT,,,,,,['Facial paralysis'],UNK,PFIZER\BIONTECH, 976867,NY,49.0,M,"Pressured Speech; Weakness and tremors to both limbs; Weakness and tremors to both limbs; muscle spasm; This is a spontaneous report from a contactable Other HCP (patient). This 49-year-old male patient received his first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec202 at 17:30 in left arm at single dose for COVID-19 immunisation at the age of 49-year-old. Lot number was EK9231. Medical history included gout. Concomitant medications were unknown. On 10Jan2021, the patient experienced Pressured Speech, weakness and tremors to both limbs and muscle spasm. The events resulted in Emergency room/ department or urgent care and Hospitalization for one day. The patient was not treated for the events. COVID was tested post vaccination on 13Jan2021, Nasal Swab, polymerase chain reaction (PCR) and it resulted negative. The patient did not recover from the events.; Sender's Comments: The events pressured speech, weakness and tremors to both limbs ,muscle spasm are less likely related to suspect BNT162B2 administration given the weak time association. The available examination results would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/28/2020,01/10/2021,13.0,PVT,,,Medical History/Concurrent Conditions: Gout,,,"['Asthenia', 'Muscle spasms', 'Pressure of speech', 'SARS-CoV-2 test negative', 'Tremor']",1,PFIZER\BIONTECH,OT 976870,,,M,"It affected him neurologically and he can't walk, nor stand without wanting to vomit.; It affected him neurologically and he can't walk, nor stand without wanting to vomit.; It affected him neurologically and he can't walk, nor stand without wanting to vomit.; It affected him neurologically and he can't walk, nor stand without wanting to vomit.; This is a spontaneous report from a non-contactable consumer (patient's wife) A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was hospitalized on 12Jan2021 and reported that on unspecified date ""affected him neurologically and he can not walk, nor stand without wanting to vomit. Everything, and I mean everything else has been ruled out"". Events outcome were unknown. The action taken was not applicable. No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/11/2021,,,UNK,,,,,,"['Dysstasia', 'Gait inability', 'Nausea', 'Neurological symptom']",2,PFIZER\BIONTECH, 976871,TX,43.0,F,"1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; eye lower lid internal tenderness; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Dizziness; sleepiness; increased blood pressure and pulse; increased blood pressure and pulse; Then sleeplessness till 4am next day; This is a spontaneous report from a contactable Nurse A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 15Jan2021 14:45 at single dose for covid-19 immunisation. Vaccine location was right arm. Medical history included attention deficit hyperactivity disorder from an unknown date, hypothyroidism from an unknown date. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient experienced 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch on 15Jan2021 15:15 with outcome of not recovered, behind lower rt (right) ear pain, rt (right) sided neck pain, rt (right) side buttocks pain, rt (right) side thigh pain, swelling, rt (right) knee pain, and swelling on 15Jan2021 15:15 with outcome of not recovered, dizziness on 15Jan2021 15:15 with outcome of not recovered, sleepiness on 15Jan2021 15:15 with outcome of not recovered, increased blood pressure and pulse on 15Jan2021 15:15 with outcome of not recovered, then sleeplessness till 4am next day (as reported) on 15Jan2021 15:15 with outcome of not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/15/2021,01/15/2021,0.0,SEN,,,Medical History/Concurrent Conditions: ADHD; Hypothyroidism,,,"['Arthralgia', 'Blood pressure increased', 'Dizziness', 'Ear pain', 'Eye pain', 'Heart rate increased', 'Hyperaesthesia', 'Hypoaesthesia', 'Insomnia', 'Joint swelling', 'Musculoskeletal pain', 'Neck pain', 'Pain in extremity', 'Paraesthesia', 'Somnolence', 'Swelling', 'Swelling face', 'Tenderness']",1,PFIZER\BIONTECH, 976881,,,F,"acute vertigo/most likely benign paroxysmal positional vertigo; This is a spontaneous report from a contactable physician (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly, on 22Dec2020 at a single dose (reported as 0.3) for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient experienced acute vertigo/most likely benign paroxysmal positional vertigo on 02Jan2021, which was reported as medically significant. The patient could barely get out of bed on 02Jan2021. The clinical course was reported as follows: The patient did not have any systemic symptoms after receiving the first vaccine but 12 days (as reported) after, she did have some acute vertigo; reported as very serious for her. She could barely get out of bed the first couple of days after getting it. The patient went to ear-nose-and throat (ENT) because she wanted to determine the likelihood of the vertigo having anything to do with her getting the vaccine before she got her second vaccine. She was told it was most likely benign paroxysmal positional vertigo, most likely positional, had nothing to do with the vaccine, and that she was okay to go ahead and get her second vaccine. The vertigo went away within a couple of days. The patient clarified that by 06Jan2021, she was feeling much better and recovered completely. The clinical outcome of acute vertigo/most likely benign paroxysmal positional vertigo and barely get out of bed was recovered on 06Jan2021. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: The reported acute vertigo/most likely benign paroxysmal positional vertigo occurred 12 days after the first dose of COVID 19 vaccine, BNT162B2, is considered an intercurrent disease, unlikely related to BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,01/02/2021,11.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Mobility decreased', 'Vertigo positional']",1,PFIZER\BIONTECH,OT 976882,WI,37.0,F,"dyspnea; myalgias; chest pain/Chest pain is moderately severe and worse with deep inspiration; back aches; feeling clammy; This is a spontaneous report from a contactable pharmacist. A 37-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3248, expiration date unspecified), via an unspecified route of administration on 11Jan2021 12:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 21Dec2020 and experienced fever, chills, myalgias, and some sensory changes to the left arm; and vancomycin and experienced allergies. On 11Jan2021, the patient experienced dyspnea and myalgias following her second vaccination today. It was reported that she received the second dose of the vaccine around noon and then began having dyspnea and chest pain around an hour later. Chest pain was moderately severe and worse with deep inspiration. Patient was also having back aches and was feeling clammy. Patient represented to the vaccine site and was brought to the emergency room department/urgent care for evaluation. Patient denied any history of vaccine associated reactions. The patient received therapy for the events which included acetaminophen, ketorolac and intravenous (IV) fluids. The patient had no other vaccine in four weeks. Outcome of events was unknown.; Sender's Comments: Based on the time association, the events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/11/2021,0.0,PVT,,,,,,"['Back pain', 'Chest pain', 'Cold sweat', 'Dyspnoea', 'Myalgia', 'Painful respiration']",2,PFIZER\BIONTECH, 976937,CA,78.0,M,"perfuse sweating; mild tenderness of arm; Muscle pain; Chills; Weakness; This is a spontaneous report from a contactable physician (patient). A 78-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2) intramuscular at single dose at left deltoid on 11Jan2021 around 13:00 for covid-19 immunisation, administered at hospital. Medical history was none, he was basically healthy. There were no concomitant medications. No prior vaccinations (within 4 weeks), but the patient received the 1st dose of bnt162b2 (BNT162B2) at single dose exactly 3 weeks before 1st dose on 21Dec2020 for covid-19 immunisation. No additional vaccines administered on same date of bnt162b2. The patient began to have muscle pain, chills, and weakness about 8 hours or so after the 2nd vaccine on 11Jan2021. He states these symptoms have maybe gotten a little better, but have been continuing on for 2-3 days now. He is also experiencing perfuse sweating during 13Jan2021night. Right now, he was not experiencing this. Maybe a little bit, but not much. The caller experienced mild tenderness of arm on 12Jan2021: he explained when you press his arm, it hurts a little bit. No events required a visit to Emergency Room or Physician Office. The outcome of muscle pain was and perfuse sweating was unknown, of chills, weakness was recovering, of mild tenderness of arm was not recovered. The patient was his own primary doctor. The reporter considered all events as medically significant and he believed these symptoms are related to receiving the vaccine because he stated he was okay before that. No further information expected. Information about lot/batch number has been requested.; Sender's Comments: There is a reasonable possibility that the event muscle pain was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other events with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Chills', 'Hyperhidrosis', 'Myalgia', 'Tenderness']",UNK,PFIZER\BIONTECH,OT 976938,MA,,U,"tested positive for covid after 1st dose received on 03Jan2021; tested positive for covid after 1st dose received on 03Jan2021; This is a spontaneous report from a contactable Nurse via a Pfizer-sponsored program named Pfizer First Connect. This nurse reported similar events for 15 residents and 5 staff members. This case was for the 10th of 15 residents. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 03Jan2021 at the first single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced tested positive for covid in Jan2021 after 1st dose received. The outcome of events was unknown. Information about batch/lot number has been requested.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 976939,NJ,50.0,F,"involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscle cramping; chest pain; Feels bad; severe joint aches; tremor; nausea; severe body pain in her back and knees; severe body pain in her back and knees; Weakness; Headache; This is a spontaneous report from a contactable Other HCP reported for self. This 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 07:00 on Deltoid Left at single dose (Lot # EK9231) for covid-19 immunisation. Concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 via Intramuscular at age of 50 years old on Deltoid, Left at single dose (Lot # EH9899) for covid-19 immunisation, experienced Tingling lips, Swollen lips, and the Benadryl took away the lip tingling and swelling, Tachypnea, Myalgia, Joint pain, severe headache, Weakness generalized, Nausea, she said she was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. Reported she received the second COVID-19 Vaccine dose on 12Jan2021 at 7:00AM in the left Deltoid. She said the adverse reaction she experienced after the second vaccine dose was slightly different from what she experienced with the first dose. She said about 10 hours after the COVID-19 Vaccine was administered, clarifying at around 17:00PM 12Jan2021, she started having severe body aches(disability), and involuntary muscle cramping (disability), like tetanus. She said even her diaphragm was cramping. She said she had chest pain on 12Jan2021(disability), tremors on 12Jan2021 (medically significant), and body aches, but doesn't think she had fever. She said the symptoms are still going on like with the first COVID-19 Vaccine dose, but she has more severe joint aching on 12Jan2021 (disability), weakness on 12Jan2021 (disability), and nausea on 12Jan2021 (medically significant). She said her knees feel like she was beaten severely. She said she aches so bad, it hurts having pants on. She said she does not have a headache or tremors now, but did have a headache on 12Jan2021 (medically significant) and tremors in the beginning. She said she feels the most pain in her back and knees. She said she feels really bad on 12Jan2021(disability). After the second dose on 12Jan2021, she reports severe body pain in her back and knees (disability). She reports almost feeling like she has tetanus- involuntary muscle contractions in her diaphragm on unknown date(disability), tremor, cold, chills, nausea, muscle cramps/chest pain. 'Felt like a heart attack. It was out of this world'. She still has nausea, severe pain all over my body, she can't be touched, and even wearing pants hurts. She said she is a healthy person with no chronic disease. She said she had nothing wrong with her prior to getting the COVID-19 Vaccine. Reported she hurts so bad, she can't even lift her arm. She completed a covid 19 PCR test after the first dose in Dec2020, which was negative. Treatment were received for the events severe body pain in her back and knees, involuntary muscle contractions in her diaphragm, tremor, nausea, muscle cramping, chest pain, Feels bad, more severe joint aching, severe body aches, Weakness, headache, chills, cold. Reported she has taken 1500mg of Motrin. Outcome of the severe body aches, Involuntary muscle cramping, Chest pain, severe joint aches, weakness, Nausea, Back pain, Knee pain, Feels bad was not recovered. Outcome of the event Tremor was recovered in Jan2021, Headache was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/12/2021,01/12/2021,0.0,PVT,,,,,,"['Arthralgia', 'Asthenia', 'Back pain', 'Chest pain', 'Chills', 'Feeling abnormal', 'Feeling cold', 'Headache', 'Lip swelling', 'Mobility decreased', 'Muscle contractions involuntary', 'Muscle spasms', 'Myalgia', 'Nausea', 'Pain', 'Pallor', 'Paraesthesia oral', 'SARS-CoV-2 test negative', 'Sensitive skin', 'Tachypnoea', 'Tremor']",2,PFIZER\BIONTECH, 976946,,,M,"Covid positive; Covid positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable consumer reported for patient (husband). This reporter reported similar events for 2 patients (reporter and reporter's husband). This is 2nd of 2 reports reported for reporter's husband. A male patient of an unspecified age received BNT162B2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter and her husband both had vaccine on Friday and they discovered that they both are Covid positive on Monday. Reporter does not have symptoms but her husband (patient) does, the question is wants to know whether they should still get the second shot? Events outcome was unknown. Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021049653 Same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 976965,AZ,45.0,M,"coronary spasm; STEMI COVID vaccine induced; slight 1-2/10 substernal chest pain on/off; fever of 101 to 101.7; diffuse severe muscle aches; tachycardia of 110 to 130; painful lymphadenopathy of the ipsilateral axilla and clavicular lymph node (LN); This is a spontaneous report from a contactable physician (patient). A 45-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142), via an unspecified route of administration in the left arm on 13Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included benign prostatic hyperplasia (BPH). Concomitant medication included alfuzosin. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) in the left arm on 23Dec2020 16:00 at the age of 44 years old for COVID-19 immunization. On 14Jan2021, the patient started having fever of 101 to 101.7, diffuse severe muscle aches, and tachycardia of 110 to 130. Thursday evening (14Jan2021) through Sunday (17Jan2021), the patient also had painful lymphadenopathy of the ipsilateral axilla and clavicular lymph node (LN). Thursday evening (14Jan2021), the patient had slight 1-2/10 substernal chest pain on/off. Friday evening around 23:30 (15Jan2021), the patient had chest pain substernal 7-8/10 that lasted for one hour. The burning sensation was worse with cold air. It resolved with paracetamol (TYLENOL) and ibuprofen. Monday early morning at 04:00 (18Jan2021), the patient experienced STEMI COVID vaccine induced wherein the patient woke up with 10/10 chest pain and shoulder pain which lasted for 30 to 40 minutes and resolved with paracetamol and ibuprofen. The patient also decided to check blood work Monday morning (18Jan2021) while in the hospital. Trop came back 16.28 ng/ml. This is the old trop not high sensitivity. Normal high is 0.30 ng/ml. The patient went to the hospital. ECG showed ST elevation inferior lead. Left heart catheterization was done. The patient have clean coronaries. No evidence of any atherosclerosis. Echocardiogram showed normal EF. No wall motion abnormality. It was concluded that the patient also had coronary spasm. The patient underwent other lab test and procedure which included nasal swab COVID test showed negative on 18Jan2021. Outcome of the lymphadenopathy was recovered on 17Jan2021, of the chest pain was recovered on Jan2021, of the coronary spasm and STEMI was recovering, while of the remaining events was unknown. The events coronary spasm and STEMI resulted in hospitalization and life threatening illness.; Sender's Comments: The reported coronary spasm with chest pain and suspected STEMI were likely related to the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship, and no evidence of any atherosclerosis during left heart catheterization. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,,Not Reported,N,01/13/2021,01/14/2021,1.0,UNK,ALFUZOSIN,,Medical History/Concurrent Conditions: BPH,,,"['Acute myocardial infarction', 'Arteriospasm coronary', 'Arthralgia', 'Burning sensation', 'Catheterisation cardiac normal', 'Chest pain', 'Echocardiogram normal', 'Ejection fraction normal', 'Electrocardiogram ST segment elevation', 'Lymphadenopathy', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tachycardia', 'Troponin increased']",2,PFIZER\BIONTECH, 976967,NY,57.0,F,"Felt tired; Headache; Arm sore; patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything; patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything; This is a spontaneous report from a contactable consumer reported for self. This 57-year-old female patient received the first dose of BNT162B2 (Lot number ELD140, Expiry Date Mar2021) via unspecified route of administration on an unspecified date at single dose, and second dose of BNT162B2 (maybe the same Lot/ Expiry date as the first dose) via unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything. The patient clarified that she was tested positive at work. The patient had the nose swab 12Jan2021 at job and the patient had the second dose of the shot (vaccine). The patient stated that she felt tired in the morning and had headache and arm was sore, other than that the patient felt she was fine. The patient didn't have any chills or anything. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/12/2021,,OTH,,,,,,"['Fatigue', 'Headache', 'Pain in extremity', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 976970,TN,43.0,F,"Rash; Hives; Throat started to close up; Voice changed/ Functional dysphonia; This is a spontaneous report from a contactable other health professional reporting for herself. A 43-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), intramuscular in the right arm, on 29Dec2020 at 16:42, at single dose, for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing, blood pressure high from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing, drug allergy to triptans from an unknown date and unknown if ongoing. Past drug event included drug allergy to Topamax and Rocephin both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced rash on 29Dec2020 at 16:45 with outcome of not recovered, hives on 29Dec2020 at 16:45 with outcome of not recovered, throat started to close up on 29Dec2020 at 16:45 with outcome of not recovered. The patient was given Benadryl and EpiPen and was rushed to the emergency room (ER). The events needed emergency room visit and physician office visit. She was admitted into the hospital for 3 days and received Solu-Medrol and intravenous Benadryl every 6 hours until discharge. The reporter stated that after the reaction her voice changed. She was visited by an otorhinolaryngology (ENT) doctor on 19Jan2021 and she had functional dysphonia. Therapeutic measure included speech therapy. Outcome was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events rash, hives and throat tightness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,3.0,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Anxiety; Blood pressure high; Depression; Diabetes; Drug allergy (To triptians); Migraine,,,"['Dysphonia', 'Rash', 'Throat tightness', 'Urticaria']",1,PFIZER\BIONTECH,OT 976973,NJ,44.0,M,"Elevated blood pressure (180/116 highest recorded); dizziness; weakness lasting several hours; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 20Jan2021 14:15 at single dose for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. The patient medical history was not reported. Concomitant medication included atorvastatin (LIPITOR), 40 mg daily, butalbital, caffeine, paracetamol (FIORICET). The patient experienced elevated blood pressure (180/116 highest recorded), dizziness and weakness lasting several hours on 20Jan2021 14:30 with outcome of recovering. The events were considered life-threating (immediate risk of death from the event) and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. No treatment was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,UNK,LIPITOR [ATORVASTATIN]; FIORICET,,,,,"['Asthenia', 'Blood pressure increased', 'Dizziness']",1,PFIZER\BIONTECH, 976974,CO,51.0,M,"tested positive for COVID via nasal swab; tested positive for COVID via nasal swab; This is a spontaneous report from a contactable healthcare professional. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ165), via an unspecified route of administration at left arm on 17Nov2020 18:45 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID via nasal swab on 27Dec2020. The outcome of the events was unknown.; Sender's Comments: The 51-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ165), on 17Nov2020 and tested positive for COVID via nasal swab on 27Dec2020. It was unknown whether he received second dose. Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information is needed for full meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,11/17/2020,12/27/2020,40.0,WRK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 977060,ND,83.0,F,"Per the ED Physician documentation and report from family, patient had been experiencing some chest pain for the last week to week and a half with SVT before presenting to the emergency department. patient had a holter monitor study earlier in the week that results were pending. 1/23/21- patient arrives to the ED via ambulance with complaints of sharp chest pain, palpitations and heart rate in 150's. Patients troponin level then elevated and it was determined patient was having a NSTEMI. 1/24/21- patient had recurrent episodes of SVT and family decided patient would benefit from further cardiac workup so she was transferred to a higher level of care. Unknown if patient has discharge from the facility we transferred her to. This patient is felt to be of significance since she is 1/3 patients currently in our facility who developed cardiac/blood issues post vaccination from the same pharmacy with the same lot number vaccine. VAERS reports were put in for all three to determine if further investigation is needed.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/07/2021,01/23/2021,16.0,PHM,"acetaminophen 650mg BID, albuterol 2 puffs INH Q4H PRN, aspirin 81mg daily, calcium carbonate 500-1000mg Q6H PRN, calcium carbonate/Vitamin D3 600/400 tab 1 tablet daily, insulin glargine Hum.Rec.Analog 25 units SUBCUT BID, magnesium oxide",unknown,"CHF, hyperlipidemia, diabetes, COPD, urinary incontinence, chronic constipation, GERD, renal insufficiency, osteoporosis",,NKA,"['Acute myocardial infarction', 'Chest pain', 'Electrocardiogram', 'Electrocardiogram ambulatory', 'Haematology test', 'Laboratory test', 'Palpitations', 'Supraventricular tachycardia', 'Troponin increased']",1,PFIZER\BIONTECH,IM 977061,LA,70.0,M,"Pt admitted 22 Jan 21 with (HFpEF) heart failure with preserved ejection fraction; AKI (acute kidney injury); Acute kidney injury superimposed on chronic kidney disease; Acute on chronic diastolic congestive heart failure; Acute on chronic heart failure with preserved ejection fraction; Acute respiratory failure with hypoxia; Anemia due to stage 3 chronic kidney disease, unspecified whether stage 3a or 3b CKD; Anemia, unspecified type; COVID-19; Chest pain; Chronic pain syndrome; Gastroesophageal reflux disease without esophagitis; History of COVID-19; Hypertension, essential; Hypertensive heart and kidney disease with HF and with CKD stage II; Hypoxia; Peripheral vascular disease due to secondary diabetes mellitus; Prostate cancer; Shortness of breath; Type 2 diabetes mellitus with stage 3 chronic kidney disease, with long-term current use of insulin, unspecified whether stage 3a or 3b CKD as of today still hospitalized",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,01/20/2021,01/22/2021,2.0,PVT,,,,,CANDESARTAN; ZINC,"['Acute kidney injury', 'Acute left ventricular failure', 'Acute respiratory failure', 'Anaemia', 'COVID-19', 'Cardiac failure', 'Cardiac failure acute', 'Cardiac failure congestive', 'Chest pain', 'Chronic kidney disease', 'Gastrooesophageal reflux disease', 'Hypoxia', 'Pain']",1,PFIZER\BIONTECH,IM 977065,LA,87.0,F,"Pt. admitted to the hospital on 22 Jan 21 with Acute on chronic combined systolic and diastolic congestive heart failure; CHF (congestive heart failure); Chest pain, unspecified type; Coronary artery disease involving native coronary artery of native heart without angina pectoris; Debility; Ischemic cardiomyopathy; Shortness of breath; Systolic and diastolic CHF, acute on chronic Still admitted as of today",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/20/2021,01/22/2021,2.0,PVT,,,,,DOXYCYCLINE; LORAZEPAM; MORPHINE SULFATE; SULFA (SULFONAMIDE ANTIBIOTICS),"['Asthenia', 'Cardiac failure acute', 'Cardiac failure congestive', 'Chest pain', 'Coronary artery disease', 'Dyspnoea', 'Ischaemic cardiomyopathy', 'Left ventricular failure']",1,PFIZER\BIONTECH,IM 977073,LA,75.0,M,Pt. admitted to hospital on 23 Jan 21 with Abdominal distention; Abdominal pain; Benign prostatic hyperplasia without lower urinary tract symptoms; Bilateral lower extremity edema; Chest pain; Essential hypertension; Generalized abdominal pain; Lower extremity edema; Mesenteric mass; Pain of upper abdomen; Shortness of breath; Weakness Discharged 25 Jan 21,Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/21/2021,01/23/2021,2.0,PVT,,,,,Unknown,"['Abdominal distension', 'Abdominal pain', 'Abdominal pain upper', 'Abdominal wall mass', 'Asthenia', 'Benign prostatic hyperplasia', 'Chest pain', 'Dyspnoea', 'Essential hypertension', 'Oedema peripheral']",1,MODERNA,IM 977075,LA,72.0,M,"Pt. admitted on 23 jan 21 with AMS, Chest pain; Shortness of breath. He was discharged on 21 Jan 21",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/22/2021,01/23/2021,1.0,PVT,,,,,unknown,"['Chest pain', 'Dyspnoea', 'Mental status changes']",1,MODERNA,IM 977101,OR,32.0,F,"8bdays after recieved the vaccine, a red bump, that felt like a bug bite, showed up. Bump itches, and has began to spread out. It is warm/hot to touch. Area of ridged, as a bug bite would be, but is now about the size of my palm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,WRK,Prenatal,,,"Flu like symptoms, after flu vaccine",,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 977103,CO,78.0,F,Low plts at 6. Admitted to hospital.,Not Reported,,Not Reported,Yes,,Not Reported,U,01/20/2021,01/26/2021,6.0,OTH,,,,,Venum,['Platelet count decreased'],1,PFIZER\BIONTECH, 977238,CA,86.0,M,"Vaccine admin Wed 3 pm. Thurs no problem. Friday am, patient woke up almost fully blind right eye.",Not Reported,,Not Reported,Yes,2.0,Yes,N,01/20/2021,01/22/2021,2.0,PVT,Baby Aspirin,Arteriosclerosis,Arteriosclerosis,,Non-specific,"['Aortic stenosis', 'Blindness unilateral', 'Carotid artery stenosis', 'Chest X-ray normal', 'Computerised tomogram head normal', 'Echocardiogram normal', 'Left ventricular hypertrophy', 'Magnetic resonance imaging brain normal', 'Retinal artery thrombosis', 'Systolic hypertension']",1,MODERNA,IM 977242,OH,36.0,M,Patient developed myopericarditis requiring hospitalization four days after receiving second dose of moderna vaccine. He developed left arm pain and numbness as well as substernal chest pressure. He was admitted.,Not Reported,,Not Reported,Yes,,Not Reported,Y,01/22/2021,01/26/2021,4.0,PVT,None,None,None,,None,"['Chest discomfort', 'Electrocardiogram ST segment elevation', 'Hypoaesthesia', 'Magnetic resonance imaging heart', 'Myocarditis', 'Pain in extremity', 'Troponin increased']",2,MODERNA,IM 977301,MI,34.0,F,"Patient with underlying MS and pregnancy. Patient reported that Fever, body aches, chills, fatigue after administration of 2nd dose. Presented to the Emergency Department / OB triage in labor 4 days later (1.24.21) Patient is a 34 y.o. female at 37w0d with Estimated Date of Delivery: 2/14/21 who presents today with spontaneous labor. HOSPITAL COURSE: Patient underwent an uncomplicated vaginal delivery and was discharged home in stable condition. ESTIMATED DUE DATE: Estimated Date of Delivery: 2/14/21 GESTATIONAL AGE AT DELIVERY: 37w0d. Patient weight = 2.63 KG",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/20/2021,01/24/2021,4.0,PVT,Escitalopram; ocrelizumab (on hold during pregnancy); prenatal vitamin,Pregnancy; Multiple Sclerosis,"Multiple Sclerosis; pregnancy; Lyme disease, anxiety, GBS bacteremia;",,NKDA,"['Chills', 'Delivery', 'Exposure during pregnancy', 'Fatigue', 'Pain', 'Premature labour', 'Pyrexia']",2,PFIZER\BIONTECH,IM 977314,MI,56.0,F,"chills, fever, diarrhea, unable to urinate, dehydrated went to emergency room and was admitted IV fluids",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/22/2021,01/23/2021,1.0,PVT,"Magnesium, Prograf, Albuterol, Lipitor, Singular, Prednisone, Vitamin D, Mycophanolate Motifo, Omeprazole, Oxycodone, Klor-con, Fludrocortisone, Synthroid , Cholecalciferol, Gabapentin, Docusate sodium , Chlorhexidine, Tessalon pearles, Ond",none,"2003 Transplant kidney and pancreas, hyperlipidemia, osteoporosis, anemia, hypothyroidism, allergic Rhinitis, leukocytosis neuropathy,",,Septra,"['Blood test', 'Chills', 'Dehydration', 'Diarrhoea', 'Pyrexia', 'Urinary retention', 'Urine analysis']",1,MODERNA,IM 977319,MI,46.0,M,Notified by patient's sister on 1/26/2021 that patient died in his sleep on 1/25/2021. She did not know cause of death.,Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/25/2021,27.0,PUB,Unknown,Unknown,Unknown,,Unknown,['Death'],1,MODERNA,IM 977320,MI,83.0,F,"about 20+ hours after vaccination resident was having hard time breathing, 911 was called. Resident coded multiple times at the facility after CPR she was taken to ICU. She coded again and was placed on life support. Due to her choice to not be on life support she passed on 11/26/2021.",Yes,01/26/2021,Not Reported,Yes,1.0,Not Reported,N,01/25/2021,01/26/2021,1.0,SEN,unknown,"acute pancreatitis, gerd, ibs, OA, rheumatoid arthritis, HTN, H/o falls, osteoporosis, pre-diabetes, hyperlipidemia, diverticulosis, interstitial lung disease, permatomyoitis","acute pancreatitis, gerd, ibs, OA, rheumatoid arthritis, HTN, H/o falls, osteoporosis, pre-diabetes, hyperlipidemia, diverticulosis, interstitial lung disease, permatomyoitis",,azathioprine (Imuran),"['Cardio-respiratory arrest', 'Death', 'Dyspnoea', 'Intensive care', 'Life support', 'Resuscitation']",1,MODERNA,IM 977351,NC,80.0,F,"Pt received her Moderna COVID-19 Vaccine at 2:50 pm on 1/25/2021. Pt tolerated administration well and was monitored for 15 minutes inside the agency. She was accompanied by her son. When exiting the building at approximately 3:15pm, pt continued walking off of the side walk into the flower bed. She then was noticed by son to have confused and jumbled speech. Staff from The Agency and EMS was on the scene immediately after this was observed and 911 was called for EMS. Son reports this is not her baseline.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/25/2021,01/25/2021,0.0,PUB,Not known,Not known,Not known,,None known,"['Disorganised speech', 'Gait disturbance']",1,MODERNA,IM 977358,FL,99.0,M,cough congestive heart failure death,Yes,01/21/2021,Not Reported,Yes,1.0,Not Reported,N,01/08/2021,01/12/2021,4.0,PUB,"Lisinopril, ASA, Paxil, Amlodipine",,"anemia, mild renal insufficiency, hypertension",,none,"['Cardiac failure congestive', 'Chest X-ray', 'Cough', 'Death', 'Full blood count', 'Laboratory test', 'SARS-CoV-2 test', 'Ultrasound chest']",1,MODERNA,IM 977362,MI,56.0,F,"Moderna COVID-19 Vaccine EUA On 1/9/2021 I suffered a lacunar stroke, Symptoms of left sided paralysis . The symptoms came and went. I was life flighted to Hospital. Underwent several test . CT,MRI,ECHO and labs among other test I was in patient ICU for 3 days. Discharged home. The longest event lasted 4 hours . My BP was extremely elevated. I had borderline HTN in past but never that high. Fortunately I have regained the use of my left side and minimal side effects remain. Unsure if the vaccine could have elevated my BP",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/06/2021,01/09/2021,3.0,PUB,none,none,none known at that time,,PCN,"['Blood pressure increased', 'Computerised tomogram', 'Echocardiogram', 'Electrocardiogram', 'Hemiplegia', 'Intensive care', 'Laboratory test', 'Lacunar stroke', 'Magnetic resonance imaging']",1,MODERNA,IM 977426,GA,70.0,M,Patient has a history of advanced melanoma with brain metastasis. He developed seizure disorder as well and had some mild seizures at home over the prior month. He received the vaccine at 4pm and was monitored in the office for 15 minutes. He then went home with his daughter whom he lives with. He ate dinner with her and read until 8pm when he went to his room. She found him in his room at 9pm unresponsive with seizures. Hospice was alerted and recommend oral valium. He continued to be unresponsive and expired the following day at 7:30 pm.,Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,PVT,"Tramadol, Dexamethasone, Pantoprazole, Dilatin, Plaxis, Aspirin, VImpat, Keppra, Clopidogrel",1. Melanoma with brain metastasis 2. Seizure disorder,1. Melanoma with brain metastasis 2. Seizure disorder,,None,"['Condition aggravated', 'Death', 'Seizure', 'Unresponsive to stimuli']",1,MODERNA,IM 977478,FL,1.0,M,Patient received MMR and Varicella vaccine on 11/12/2020 and Hep A and flu vaccine on 12/03/2020 Pt developed easy bruising and petechiae on 12/09 dx Idiopatic Thrombocytopenia on 12/17/2020 treated at Med Ctr,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,11/12/2020,12/09/2020,27.0,OTH,None,None,None,,no allergies,"['Blood test', 'Computerised tomogram head', 'Contusion', 'Immune thrombocytopenia', 'Petechiae', 'Skeletal survey']",1,MERCK & CO. INC.,SC 977503,DC,37.0,F,"First round of moderna vaccine received 28days prior when I was not pregnant. After first dose, I had a lard red, indurated but painless bump on my arm for a week. I became pregnant about two weeks after first dose and this, the second dose, was given at four weeks pregnant (due date oct 1 2021). Side effects included fever, chills, muscle aches, very sore arm, light-headedness, tachcardia.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/26/2021,1.0,PVT,None,None,None,,None,"['Chills', 'Dizziness', 'Exposure during pregnancy', 'Myalgia', 'Pain in extremity', 'Pyrexia', 'Tachycardia']",2,MODERNA,SYR 977531,,25.0,M,"25yo M with no sig PMHx or FMHx for ACS presents with 4 days of viral symptoms: f/s/c/myalgia/fatigue/HA that progressed to include CP for last 3 days. Classic positional CP, dull pressure, worse lying flat, better leaning forward, feels every heart contraction. Work up consistent with Acute Pericarditis and treated outpatient with Ibuprofen and Colchicine. symptoms worsened and he was evaluated and admitted overnight hospital for observation due to elevated troponin and STE on EKG. Pt stable and discharged next day.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/22/2021,01/24/2021,2.0,PVT,,,,,,"['Blood potassium normal', 'Chest X-ray normal', 'Chest discomfort', 'Chest pain', 'Chills', 'Echocardiogram abnormal', 'Electrocardiogram ST segment elevation', 'Fatigue', 'Full blood count normal', 'Headache', 'Lymphocyte count normal', 'Myalgia', 'Palpitations', 'Pericardial effusion', 'Pericarditis', 'Pyrexia', 'Respiratory viral panel', 'SARS-CoV-2 test negative', 'Troponin increased']",2,PFIZER\BIONTECH,IM 977593,MN,71.0,F,"Patient is a 71-year-old female with PMH of type 2 diabetes, hypertension, hyperlipidemia, cataracts, glaucoma who was transferred from Medical Center as a stroke code after she presented there for right-sided weakness, facial droop and visual changes. Patient was given TPA in the past she was within window and she was then transferred here for further management. Patient's symptoms continue to resolve. She was admitted in the ICU and managed by neuro critical care and neurology. Further imaging including CTA head and neck, MRI brain did not reveal any stroke. An assessment of small vessel disease was made which likely resolved after TPA was given. Patient was assessed by PMR and PT/OT and deemed safe to go home with family care and no restrictions. Echo, telemetry and EKG showed no signs of cardiac involvement. Patient was started Plavix x21 days and chronic baby aspirin. She was also started on Crestor 20 mg daily. Patient is to follow-up with neurology in 3 months as she got TPA. She will also follow-up with her PCP on discharge.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,01/08/2021,01/11/2021,3.0,PHM,"amlodipine, simvastatin, metformin, losartan, omeprazole","Pt had strep throat that was treated on January 4, 2021","hypertension, DM2, GERD, high cholesterol",,Aspirin,"['Angiogram cerebral normal', 'Arteriogram carotid normal', 'Cardiac telemetry normal', 'Cerebral small vessel ischaemic disease', 'Echocardiogram normal', 'Electrocardiogram normal', 'Facial paralysis', 'Hemiparesis', 'Intensive care', 'Magnetic resonance imaging brain normal', 'Visual impairment']",1,PFIZER\BIONTECH,IM 977663,,77.0,F,COVID19 Infection,Not Reported,,Not Reported,Yes,,Not Reported,,01/12/2021,01/18/2021,6.0,UNK,,,,,,['COVID-19'],UNK,MODERNA, 977680,WY,,F,"she has passed away / had leukemia / was on chemotherapy; she has passed away / had / cancer / was on chemotherapy; she passed / from dementia he thinks; she fell at the house; This case was reported by a consumer via other manufacturer and described the occurrence of leukemia in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included cancer (Family History) (to mother). On an unknown date, the patient received Shingles vaccine. In August 2019, unknown after receiving Shingles vaccine, the patient experienced fall. On an unknown date, the patient experienced leukemia (serious criteria GSK medically significant), cancer (serious criteria GSK medically significant) and dementia (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy) and oxygen. On an unknown date, the outcome of the leukemia, cancer, dementia and fall were unknown. It was unknown if the reporter considered the leukemia, cancer, dementia and fall to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by patient's husband. Age at vaccination was not reported. It was reported that the patient was very tough hard and strong. The reporter stated that the patient had a reaction to shingle shot. The patient had leukemia and cancer and she was on chemotherapy. The patient also had dementia and she fell at house in august 2019. The reporter did not have product information for shingles vaccine lot number etc. The patient went a lot through cancer and was on oxygen 24x7. It was reported that more than a year ago the patient passed away. The patient died from unrelated cause. The reporter did not given consent to follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,08/01/2019,,UNK,,,Medical History/Concurrent Conditions: Cancer (to mother),,,"['Chemotherapy', 'Death', 'Dementia', 'Fall', 'Leukaemia', 'Neoplasm malignant']",UNK,UNKNOWN MANUFACTURER, 977740,FL,53.0,F,dizziness nausea and vomit Pounding Heachache crushing pain in my left leg numbness on my left side numbness on my face limping leaning to the left side when walking tingling on my gums and teeth,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/22/2021,01/22/2021,0.0,SEN,"Atenolol- 50 ml- twice daily , Lozartan-50ml-once daily",none,High Blood Pressure,,none,"['Computerised tomogram normal', 'Dental paraesthesia', 'Dizziness', 'Echocardiogram normal', 'Electrocardiogram normal', 'Gait disturbance', 'Headache', 'Hypoaesthesia', 'Magnetic resonance imaging normal', 'Nausea', 'Pain in extremity', 'Paraesthesia oral', 'Posture abnormal', 'SARS-CoV-2 test negative', 'Vomiting']",UNK,PFIZER\BIONTECH, 977743,IN,85.0,F,"The following day, food did not taste as it should and water tasted like metal. By January 13, 2021, extreme fatigue set in; lack of appetite; and extreme feelings of hopelessness, depression, etc. On January 14, 2021, I took my Aunt to Hospital ER and she received a positive COVID diagnosis. She was released to return home with instructions to use a pulse oximeter; move about every 2 hours and not sleep throughout the day; and to do breathing exercises. All were done. Symptoms did not abate. On January 17, 2021, I took my Aunt to Hospital to receive an infusion of antibodies. Unfortunately, her pulse ox readings dropped into the 80 percentile and she was admitted for care. Although she experienced pneumonia, she improved her pulse ox and was released on January 22, 2021 to (rehabilitation center) for outpatient care.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/08/2021,01/09/2021,1.0,PUB,Ibrance 125 mg,Receiving treatment for Stage 4 Breast Cancer (out of remission),Cancer.,,Lactose intolerance. Seasonal sinus allergies.,"['COVID-19', 'Decreased appetite', 'Depressed mood', 'Depression', 'Dysgeusia', 'Fatigue', 'Oxygen saturation decreased', 'Pneumonia', 'Taste disorder']",1,MODERNA,SYR 977788,PA,56.0,F,"developed numbness and tingling over body; pins and needles over all skin areas; numbness of legs, feet,torso; admitted to the Hospital; still have residual numbness and tingling",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/14/2021,01/22/2021,8.0,OTH,"Lamictal, Multivitamin(Womens One-a-day)",no,none,,"Penicillin, Tegretol","['Blood test', 'Hypoaesthesia', 'Magnetic resonance imaging brain', 'Paraesthesia']",1,MODERNA,IM 977864,VA,64.0,F,"Developed Left sternal chest pain with radiation to L upper arm with numbness and tingling of 3 fingers on left hand (Vaccine was administered in Right arm). Presented to ER, EKG showed inferior lead changes suggestive of ischemia. Was admitted overnight onto telemetry floor, no adverse s/s noted. Labs normal. CXR normal. Discharged next day, 1/23/21, with recommendation for cardiology follow up. Stress test, echo, and potentially cardiac MRI recommended, awaiting scheduling. Cardiology follow up scheduled Mon, 2/1/21.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/22/2021,01/22/2021,0.0,OTH,"OTC vitamins, calcium supplements, melatonin sleep, Benadryl sleep",None known,"None. Except for osteoarthritis shoulder, knee, hip",,None known,"['Chest X-ray normal', 'Chest pain', 'Electrocardiogram abnormal', 'Hypoaesthesia', 'Ischaemia', 'Laboratory test normal', 'Myocardial necrosis marker normal', 'Pain', 'Pain in extremity', 'Paraesthesia']",UNK,MODERNA,IM 977869,LA,76.0,F,"1/9/21 At 3:50 am started with nausea, weakness, and complaints of body aches. Required more assistance with ADL's than previous. @ 4:28 am: complaints of SOB, O2 sats 85% on room air. Required supplement O2, with tremors noted. PRN Zofran administered for nausea. 7:42 am noted with fever, decreased O2 sats, Tylenol administered for fever. Fever continue to climb despite Tylenol, supplemental O2 increased to 4L, rapid covid test negative, new orders to start Rocephin IM x 3 days and stat Xray which showed pneumonia. Temperature continues to remain elevated- O2 status continues to decline. Sent to ER 1/9/2021 @ 4:53 pm via ambulance. Admitted to Hospital with ABT tx for pneumonia and UTI. Respiratory status continued to decline- pulmonology consulted- Placed in ICU 1/13/21 and started on steroids. Required BiPap and was eventually weaned to supplemental O2. Multiple Covid tests- all negative. GI complaints addressed with GI consult- unremarkable. Started on PPI and Linzess. Eventually was placed on telemetry floor, closely monitored by pulmonology, and was cleared for discharge on 1/19/2021 back to nursing home.",Not Reported,,Yes,Yes,11.0,Not Reported,Y,01/08/2021,01/09/2021,1.0,SEN,,,"Heart failure, Hx of stroke, Diabetic, hypertension,",,"Invokana, Rocephin, Vancomycin","['Asthenia', 'Bilevel positive airway pressure', 'Dyspnoea', 'Intensive care', 'Loss of personal independence in daily activities', 'Nausea', 'Oxygen saturation decreased', 'Pain', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tremor', 'Urinary tract infection', 'X-ray abnormal']",1,MODERNA,IM 977901,IL,33.0,F,I had a headache starting at 5 Pm same day. Body aches/muscle aches in chest and back and a little bit fatigued. Symptoms lasted about 24 hours. I had a little arm soreness too and that lasted two. Pregnancy: May 4 expected due date and totally normal pregnancy.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,Prenatal vitamins,no,no,,no,"['Back pain', 'Chest pain', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 977933,ID,56.0,F,"EventsPatient experienced segmental and subsegmental pulmonary emboli without other preceding no evidence for DVT, no history of inherited thrombophilia or previous pulmonary embolism, no underlying cancer, surgery, or stasis. The only other complicating factor would be that she has been taking estrogen therapy prescribed by gynecology which she discontinued the day prior to her vaccine.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/16/2021,01/18/2021,2.0,PVT,Just discontinues beyaz(ocps) prescribed by gynecology,none,none,,none,"['Angiogram pulmonary abnormal', 'Fibrin D dimer increased', 'Pulmonary embolism']",1,MODERNA,IM 977961,TN,66.0,M,"january 19th during lunch, experienced a slurring of speech, left eye and left side of mouth droop. unable to hold in fluids. went to ED, stated all the tests were normal. air flighted to higher level of care facility for neurology. MRI/ CT negative. work up for stroke unfounded. 1/26 ENT visit- no definitive diagnosis. treatment with levaquin and steroids.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/30/2020,01/19/2021,20.0,PVT,metformin,none reported,none reported,,augmentin,"['Computerised tomogram normal', 'Dysarthria', 'Facial paralysis', 'Laboratory test normal', 'Magnetic resonance imaging normal', 'Neurological examination abnormal']",1,MODERNA,IM 977963,AL,81.0,M,(Report per patients wife ) Patient took his usual nap around 12pm. She found him lying in the bed unresponsvie at 2pm. EMS was not called. Patient's wife called the Funeral home.,Yes,01/26/2021,Yes,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Death', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 978002,GA,77.0,M,"The morning of Jan 20, 2021, Patient was disoriented, could not communicate well, and fell when he tried to get out of bed. He was taken to The Hospital by ambulance about 11:30 am. He is still hospitalized. Emerging symptoms include: passing a blood clot from his mouth, slight pneumonia, high white count, low kidney values, high fever, all of which fluctuated. A blood transfusion was given because of blood in the urine. He has been confused and disoriented until this morning.",Not Reported,,Yes,Yes,7.0,Not Reported,N,01/19/2021,01/20/2021,1.0,OTH,"Tramadol, Gabapentin, Lantus, Novalog, Baby Aspirin, Atorvastatin, Blood Pressure Med, Syntriod, B12, Dieuretic",none,"Chronic heart condition, Diabetes, Cellulitis, End stage deterioration of both knees and hips, Bursitis, High cholesterol, High blood pressure",,none,"['Blood urine present', 'Communication disorder', 'Confusional state', 'Culture stool', 'Disorientation', 'Fall', 'Laboratory test', 'Magnetic resonance imaging', 'Pneumonia', 'Pyrexia', 'Renal function test abnormal', 'Thrombosis', 'Transfusion', 'Ultrasound Doppler', 'White blood cell count increased']",1,MODERNA,IM 978069,PA,63.0,F,"About 5:30 or so and I was going to go to lunch at work - I felt like a heartburn and I was looking for a tums. I didn't have any. I asked a coworker because my chest felt like I had heartburn. It was really bad. Protonic - a coworker gave it to me to see if that would help. And I took it. Diaphoretic - sweating - coworker noticed that I was sweating. I had pain in my jaw. I thought I was showing signs of a heart attack. A doctor came over and we told her what was happening with me. He recommended that I should be seen right away. Next thing I know, nurse is wheeling me down to ER in wheelchair as my chest pains weren't going away but ER told me I had to go through triage and wait. Finally got seen and I had an EKG - which was good. CDU unit - was admitted to and checked Troponin levels and did blood work. Everything came back fine. My EKG was being monitored all night. At one point I was feeling something and they gave me a dose of Nitro. It gave me a headache. There all night and then I did a stress test in the morning. And I was released that day. That was my day off so I was off all work. I went back to the work the day after. My granddaughter came to stay with me over Christmas and she started having symptoms of COVID. She wasn't feeling well. /She tested positive.Symptoms for COVID began for me on December 26th and was tested for COVID on December 27th - cough; sore throat; headache, fever, not got chills or lose my taste or smell (until after those symptoms were finished); belching - lots; diarrhea; upset; nausea. Extremely tired and muscles aches, joint pain - settled in my lower back and my hip. I still struggle with those joint pain and tiredness today. They put me off work until January 12 2021. I was scheduled to get the dose 2 at 9th but didn't get it that day because of COVID illness.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/19/2020,12/21/2020,2.0,PVT,no,nothing,nothing,,penicillin; cheap metal - like nickel; bees,"['Abdominal discomfort', 'Arthralgia', 'Back pain', 'Blood test normal', 'Cardiac stress test normal', 'Chest pain', 'Cough', 'Diarrhoea', 'Dyspepsia', 'Electrocardiogram normal', 'Eructation', 'Exposure to SARS-CoV-2', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Impaired work ability', 'Inappropriate schedule of product administration', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Pain in jaw', 'Pyrexia', 'SARS-CoV-2 test positive', 'Troponin normal']",1,PFIZER\BIONTECH,SYR 978199,TX,71.0,M,Arm hurting used his oxygen at time of bed appeared vomited.,Yes,01/07/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,OTH,,Heart disease,Sleep apnea,,,"['Pain in extremity', 'Vomiting']",1,PFIZER\BIONTECH,IM 978310,CA,36.0,F,"I have had severe lymph node swelling on the right side where I got the vaccine; 24hrs post 2nd vaccination I have had a sudden onset of an extremely violent cough; My sputum is greenish/yellow brown with blood flecks; My sputum is greenish/yellow brown with blood flecks; chest tightness; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular in the right arm on 11Jan2021 15:45 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, asthma, polycystic ovarian syndrome (PCOS), endometriosis, chronic allergies, gastritis, and walnut allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), metformin, loratadine (CLARITINE), spironolactone, and calcium carbonate, colecalciferol (VITAMIN D 2000). The patient previously took first dose of bnt162b2 (lot number and expiry date not reported), intramuscular in the right arm on 21Dec2020 15:15 at single dose for COVID-19 immunisation. The patient verbalized, ""I don't know if it's related but I figured I should report just in case. I have had severe lymph node swelling on the right side where I got the vaccine. 24hrs post 2nd vaccination I have had a sudden onset of an extremely violent cough. By sudden onset, I mean I had no desire to cough and over about 30 min I developed the severe need to cough. My sputum is greenish/yellow brown with blood flecks. I've never experienced such a violent cough with so much sudden sputum production. I am using an Albuterol inhalor to help chest tightness."" Clinical outcome of chest discomfort was unknown while for the other events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on a close chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/12/2021,1.0,PVT,SYNTHROID; METFORMIN; CLARITINE; SPIRONOLACTONE; VITAMIN D 2000,,Medical History/Concurrent Conditions: Allergy; Asthma; Endometriosis; Fruit allergy; Gastritis; Hypothyroidism; Polycystic ovarian syndrome,,,"['Chest discomfort', 'Cough', 'Haemoptysis', 'Lymphadenopathy', 'Sputum discoloured', 'Sputum increased']",2,PFIZER\BIONTECH,OT 978311,FL,64.0,F,"isolated hives/generalized hives; generalized itching/itchy from head to toe; contact Dermatitis had worsened/reactivations of contact dermatitis that flared up on her right knee; contact Dermatitis had worsened/reactivations of contact dermatitis that flared up on her right knee; This is a spontaneous report from a contactable physician. A 64-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular on deltoid left from 30Dec2020 to 30Dec2020 at SINGLE DOSE for covid-19 immunisation. Medical history included contact dermatitis. There were no concomitant medications. The reporter stated that the patient had mentioned that she had contact dermatitis for several months now and before taking the COVID-19 vaccine, it has settled within a month. 6-12 hours after getting the COVID-19 vaccine, her contact dermatitis had worsened dramatically on 30Dec2020. She was prescribed high dose topical steroids by her doctor. She also developed generalized itching and isolated hives on 12Jan2021. She is trying to avoid systemic corticosteroids because it might affect the vaccine. She is also taking antihistamines but she said these interventions don't seem to be working. Stated that it has not responded to anything. The patient also stated stated that she has not taken steroids because her second dose is due in a week. Stated that the doctors do not think that it is due to the vaccine but due to reactivation (immune system reactivity) of something that had happened. Stated that they are treating it with high dose topical steroids, pepcid and hydroxyzine. Wanted to see if there was information on this sort of reaction and if they had guidance on the second shot. Had the Pfizer BioNTech Covid 19 vaccine. Outcome of the events urticaria and pruritus was not recovered while outcome of the remaining events was recovering.; Sender's Comments: The reported generalized itching and isolated hives occurred 13 days after the first dose of COVID 19 vaccine, BNT162B2. Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported events and the administration of the suspect. However, the pre-existing contact dermatitis might have provided alternative explanation towards the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Contact dermatitis,,,"['Condition aggravated', 'Dermatitis contact', 'Pruritus', 'Urticaria']",UNK,PFIZER\BIONTECH,OT 978312,CA,61.0,F,"unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/21/2020,3.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Blood test normal', 'C-reactive protein increased', 'Chills', 'Fatigue', 'Gait disturbance', 'Hyperhidrosis', 'Impaired work ability', 'Loss of personal independence in daily activities', 'Musculoskeletal stiffness', 'Myalgia', 'Neck pain', 'Pain', 'Pain in extremity', 'Positron emission tomogram normal', 'Red blood cell sedimentation rate increased', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 978313,FL,66.0,F,"Tiredness; A sore arm/Arm was a little sore; Dizziness; Passed out; Chills; Tremor in fingers; A headache; This is a spontaneous report from a contactable Nurse (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EH9899, expiry date: unknown), via an unspecified route of administration on 06Jan2021 10:30 at single dose (Right upper arm) for COVID-19 immunization. Medical history included Blood pressure (takes blood pressure medication). The patient's concomitant medications included blood pressure medication. The patient experienced a sore arm, chills, tremor in fingers and a headache when she came home from being vaccinated. The morning after, she experienced dizziness, tiredness and passed out. She then checked her blood pressure and it was fine and then she went to bed and slept all day. She got up around 7 pm and was fine. It was further reports that the patient received first COVID Vaccine on 06Jan2021. She came home and was fine. Arm was a little sore. During night had chills and noticed fingers had tremors. Had a bad headache. Woke up in morning and went to do usual things. Was dizzy and passed out. Woke up on floor. Husband helped her back into bed and she slept the whole day. After that she was absolutely fine. They were curious, but a little bit concerned about taking the second dose. Advised patient to follow up with primary care physician. She went to primary care physician yesterday. Primary care physician advised her to take the second dose of COVID Vaccine stating he didn't see why she couldn't take it. HCP Details: Address and email address are unknown Received first dose of COVID Vaccine on 06Jan2021 around 10:30. Chills: began at 23:00 Fingers had tremors: began 23:00 Bad headache: did not provide time of onset Dizzy and passed out: 08:00 Woke up absolutely fine on 07Jan2021 around 19:00 Indication: 66 years old and it was available to her Causality: Yes, because she was fine before then History and Investigations: Takes blood pressure medication, but blood pressure has been normal. Product name not provided by caller. Vaccination facility type was at a skilled nursing facility. The outcome of the events was unknown. Chills, Tremor in fingers, headache, Dizziness, and Passed out were reported as Medically significant events. Reaction assessed for Chills, Fingers had tremors, Had a bad headache, Dizzy, and Passed out. Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including chills, tremor in fingers, headache, dizziness, and passed out, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,SEN,,,Medical History/Concurrent Conditions: Blood pressure abnormal (Takes blood pressure medication),,,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Hypersomnia', 'Loss of consciousness', 'Pain in extremity', 'Tremor']",1,PFIZER\BIONTECH, 978314,PA,44.0,F,"feeling cold/coldness; increased temperature/she took her temperature and it was 100.2/fever; body numbness/body started to feel numb; This is a spontaneous report from a contactable nurse reported for herself. A 44-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular at left deltoid on 13Jan2021 16:00 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient historic vaccine included the first dose of BNT162B2 on 22Dec2020 for covid-19 immunization. The patient body started to feel numb on 13Jan2021, she was feeling cold/coldness on 14Jan2021, increased temperature on 14Jan2021 and she took her temperature and it was 100.2, stated that she knew that a fever is a side effect. She was only concerned with the body numbness and wanted to know if body numbness was anything to be concerned about. The reporter assessed events was related to Pfizer Covid vaccine and as serious due to medically significant. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible temporal association, the Company considers the reported events of hypoesthesia, pyrexia and feeling cold are possibly related to suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/13/2021,0.0,UNK,,,,,,"['Feeling cold', 'Hypoaesthesia', 'Pyrexia']",2,PFIZER\BIONTECH,OT 978315,VA,40.0,F,"Severe proximal myositis of upper and lower extremities/ proximal upper and lower muscle weakness/ vaccine related myositis; dysautonomia; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899), intramuscular in the left arm on 18Dec2020 at 05:00 PM at a single dose for COVID-19 immunization. Medical history included premature ventricular contractions (PVCs) with heart ablation. Patient was not pregnant at the time of vaccination. Patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient also did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced severe proximal myositis of upper and lower extremities also reported as proximal upper and lower muscle weakness on 21Dec2020 at 09:00. The patient also experienced dysautonomia on 21Dec2020. The patient was admitted to hospital for 4 days due to the reported events and was then released. Follow up evaluations and testing showed and confirmed vaccine related myositis. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department visit or urgent care and hospitalization. No treatment for the adverse events. The patient underwent lab test which included nasal Swab: negative on 23Dec2020. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported myositis, dysautonomia and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,12/18/2020,12/21/2020,3.0,PVT,,,Medical History/Concurrent Conditions: Cardiac ablation; Premature ventricular contractions,,,"['Autonomic nervous system imbalance', 'Muscular weakness', 'Myositis', 'Vaccination complication', 'Viral test negative']",1,PFIZER\BIONTECH,OT 978521,OK,82.0,F,"This is an 82-year-old female with history of cerebellar degeneration, who had her first COVID vaccine today around 11 a.m. she was in her usual state of health prior to that time. About two and half hours afterwards she became nauseated. She had several bouts of emesis and then had a fall. She was found to be hypotensive and bradycardic. The ambulance crew actually gave her atropine at the same because she had a pulse in the 30s, improved her quickly and she presented to the ER. She is to remain very orthostatic, received several liters of IV fluid as now symptomatically better. She remains a little nauseated. She denies any headache, diarrhea, fatigue, or myalgias. She does not feel quite right. She is still dizzy with sitting up.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/26/2021,01/26/2021,0.0,SEN,"Cardizem CD 180 mg a day., CeleXA 20 mg a day., Chlorpheniramine as needed., Allegra 180 mg a day as needed., Flomax 0.4 mg b.i.d., Lipitor 10 mg at bedtime., Losartan 50 mg at bedtime., Meclizine 25 mg t.i.d. p.r.n. dizziness., Naprosyn 3",she was in her usual state of health prior to that time,"PAST MEDICAL HISTORY: 1. Cerebellar degeneration. 2. Hypertension. 3. History of rectal prolapse, status post repair. 4. DJD. 5. Hyperlipidemia. 6. Urinary difficulties. 7. Hot flashes. 8. Urinary retention.",,NKDA,"['Activated partial thromboplastin time', 'Blood lactic acid', 'Blood thyroid stimulating hormone', 'Bradycardia', 'Brain natriuretic peptide', 'Chest X-ray', 'Computerised tomogram head', 'Dizziness postural', 'Fall', 'Feeling abnormal', 'Full blood count', 'Hypotension', 'Metabolic function test', 'Nausea', 'Prothrombin time', 'Troponin', 'Vomiting']",1,PFIZER\BIONTECH,UN 978529,WV,88.0,F,"Patient developed Covid pneumonia dx 1/15/21, patient expired",Yes,01/15/2021,Not Reported,Yes,,Not Reported,N,12/31/2020,01/15/2021,15.0,PVT,"Lasix 20 mg daily, KCL ER 20 MEQ daily, Eliquis 2.5 mg twice daily, allopurinol 300 mg daily, Lyrica 50 mg daily, Metoprolol Succinate ER 50 mg daily, Amlodipine 5 mg daily, Pravstatin 20mg daily, Vit d3 25mcg daily",None,Diabetes,,"Bee Stings, Statins, Flecinide","['COVID-19 pneumonia', 'Chest X-ray', 'Computerised tomogram abdomen', 'Computerised tomogram thorax', 'Death']",1,MODERNA,IM 978535,WA,34.0,F,"Trachycardia, syncope, dizziness, facial swelling, full body numbness, rash over arms",Not Reported,,Yes,Not Reported,,Not Reported,N,12/30/2020,01/01/2021,2.0,WRK,Women's multivitamin,None,None,,None,"['Alanine aminotransferase normal', 'Albumin globulin ratio normal', 'Anion gap decreased', 'Aspartate aminotransferase normal', 'Basophil count decreased', 'Basophil percentage', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bilirubin normal', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine normal', 'Blood glucose normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea decreased', 'Carbon dioxide normal', 'Dizziness', 'Electrocardiogram abnormal', 'Eosinophil count normal', 'Eosinophil percentage', 'Globulins decreased', 'Glomerular filtration rate', 'Haematocrit normal', 'Haemoglobin normal', 'Human chorionic gonadotropin negative', 'Hypoaesthesia', 'Immature granulocyte count increased', 'Immature granulocyte percentage increased', 'Lymphocyte count normal', 'Lymphocyte percentage', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Monocyte count decreased', 'Monocyte percentage increased', 'Neutrophil count normal', 'Neutrophil percentage decreased', 'Platelet count normal', 'Protein total normal', 'Rash', 'Red blood cell count decreased', 'Red cell distribution width normal', 'Sinus arrhythmia', 'Swelling face', 'Syncope', 'Tachycardia', 'Troponin I', 'White blood cell count decreased']",1,MODERNA,SYR 978567,CA,82.0,M,Resident received the first dose of Moderna Vaccine on 01/12/2021 and Tested for COVID-19 on 01/12/2021. Resident tested positive on 01/13/2021. Resident was transferred to acute hospital on 01/19/2021 due to desaturation. Resident expired at Hospital on 01/24/2021.,Yes,01/24/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/24/2021,12.0,SEN,"Metformin 500mg PO BID for DM Phenobarbital 97.2mg QD for Seizure Dilantin 100mg, 2 caps, QHS for Seizure Eliquis 5mg BID for DVT Lipitor 10mg QHS for Hyperlipidemia",None,"DM2, Seizure, HTN, Hyperlipidemia, PVD, History of CVA, Contractures of both knees, Dysphagia.",,NKA,"['Death', 'Oxygen saturation decreased', 'SARS-CoV-2 test positive']",1,MODERNA,IM 978635,CA,96.0,M,"Patient is a 96 year old MALE with pmh colon cancer s/p resection 25 years ago, chronic urinary retention in the setting of prostate cancer with chronic foley, CKD 3b, HTN, HLD, hypothyroidism, left frontal lobe stroke on plavix here for hemoglobin of 5.9 on labs. Pt reports that he was drawing some bloodwork for renal follow up in 2 weeks and was told to come into the ED for evaluation due to low hemoglobin levels. Patient smear also contains schistocytes, more concerning for hemolytic process at play.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/12/2021,01/26/2021,14.0,MIL,1) ATORVASTATIN CALCIUM 80MG TAB TAKE ONE-HALF TABLET BY MOUTH DAILY FOR CHOLESTEROL 2) BRIMONIDINE TARTRATE 0.2% OPH SOLN INSTILL 1 DROP IN BOTH EYES THREE TIMES A DAY FOR GLAUCOMA 3) CLOBETASOL PROPIONATE 0.05%,,- colon carcinoma - hypothyroidism - osteoarthrosis involving the knee - elevated prostate specific antigen - senile macular degeneration retina - HTN - urinary incontinence - health maintenance - retention of urine - cerebral infarction - HLD - prostate cancer - stasis dermatitis - open angle glaucoma - nonexudative age-related macular degeneration - iron deficiency anemia - hyperkalemia - chronic kidney disease - bilateral lower leg edema - hypertension - GERD,,"Penicillin (pruritus, dermatitis)","['Blood smear test abnormal', 'Haemoglobin decreased', 'Red blood cell schistocytes present']",1,MODERNA,IM 978721,IL,17.0,M,"4 hours after shots, he was found to have a swollen face, SOB, sore throat and fainted; patient got Benadryl and Albuterol; went to ER and given ?prednisone and evaluated; he had difficulty swallowing for 2 days and is gradually feeling better; taking Famotidine, too.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,PVT,Albuterol MDI; Flovent MDI,none,Mild intermittent asthma; allergic rhinitis; overweight,,"Tuna, Dogs","['Dysphagia', 'Dyspnoea', 'Oropharyngeal pain', 'Swelling face', 'Syncope']",2,SANOFI PASTEUR,IM 978754,CO,93.0,F,"No symptoms appeared immediately after vaccination, although patient passed away around 6:00 pm unexpectedly. Staff talked with her last time at 5:30 pm and then found her at 6:00 pm passed away. Unknown at this time if death is directly related to receiving the vaccine.",Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,SEN,B12 vitamin 1 tab po daily Triamcinolone acetonide cream 0.5% apply 2-3 times per day Tylenol 500 mg as needed- Had not taken at all in January Loperamide 2 mg as needed-Had not taken at all in January,Hospice client Some diarrhea with colostomy bag in place general decline,"Hypertension, Dyspnea, Primary Pulmonary hypertension, Muscle weakness, pulmonary fibrosis, intraductal carcinoma breast, dizziness",,"Fosamax, Codeine derivatives",['Death'],1,PFIZER\BIONTECH,IM 978768,NY,29.0,F,"1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours, took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/20/2020,01/15/2021,26.0,OTH,Multivitamin: once a day Vitamin D3: 4000 iu/day Adderall xr: 10mg/day Melatonin: 10mg/night Trazedone: 25mg/night,,,,Morphine intolerance Phenergan intolerance,"['Anal incontinence', 'Anxiety', 'Arthralgia', 'Asthenia', 'Blood alkaline phosphatase normal', 'Blood creatinine normal', 'Blood pH increased', 'Brain natriuretic peptide increased', 'Chest discomfort', 'Chest pain', 'Complement factor C3', 'Complement factor C4 decreased', 'Cough', 'Diarrhoea', 'Dizziness', 'Dyspnoea', 'Eosinophil percentage', 'Erythema', 'Fatigue', 'Feeling hot', 'Headache', 'Hypoaesthesia', 'Hypotonia', 'International normalised ratio increased', 'Lymphocyte percentage increased', 'Migraine', 'Nausea', 'Neutrophil count decreased', 'Neutrophil percentage decreased', 'PCO2 decreased', 'Pulmonary pain', 'Pyrexia', 'Red cell distribution width normal', 'Retching', 'Sensation of foreign body', 'Urinary incontinence', 'Urticaria']",2,PFIZER\BIONTECH,IM 978848,OK,45.0,F,"lymph node swelling in axillary area on the injection side; lymph node swelling in axillary area on the injection side and it's painful; This is a spontaneous report from a contactable nurse and other hcp (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number: EL1283, expiry date: unknown), via an unspecified route of administration on 11Jan2021 09:00 at single dose (left deltoid) for COVID-19 immunization. There were no medical history and concomitant medications. On 12Jan2021, patient had lymph node swelling on the same arm as the injection site. It got worse on the 13th. She described her experience as uncomfortable. She was asking how long it is expected to last. It was further reported that the patient received first Covid-19 vaccine on 11Jan2021 and is doing well, but had lymph node swelling in axillary area on the injection side and it's painful on 12Jan2021. She wanted to know how long it will be like that and if it doesn't go away when should she seek medical attention. Received the vaccine on the 11th and a couple days later had the lymph node swelling. She then clarified lymph node swelling started the 12th. Mentioned it got worse yesterday and it's staying about the same today with the swelling and is very uncomfortable (Jan2021) and is persisting. Causality not provided. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in the past. Vaccination Facility Type was Clinic. The outcome of the events was not recovered. Events reported as medically significant.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events swollen lymph nodes and lymph node pain. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/12/2021,1.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Axillary pain', 'Discomfort', 'Lymphadenopathy']",1,PFIZER\BIONTECH, 978850,IL,56.0,F,"headache; fever; L Arm (injection site) pain/severe left arm pain; dizziness; blurred double vision and couldn't function; eyes wouldn't focus, Couldn't function; blurred double vision and couldn't function; eyes wouldn't focus, Couldn't function; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 11Jan2021 15:00 at a single dose in the left arm for COVID-19 immunization. The patient received the vaccine in a skilled nursing facility or long term care facility. The patient received no other vaccinations recently. Medical history included attention deficit disorder diagnosed at least 5 years ago for which the patient was taking Ritalin; hypothyroidism diagnosed a long time ago, probably 10 years and depression diagnosed a long time ago, probably at least 25 year, she takes a cocktail of anti-depressants for this (no further details provided about her anti-depressants). The patient also had a similar reaction of blurred double vision and couldn't function/eyes could not focus before when her doctor put her on an antibiotic (unspecified). The patient was also very overweight. Concomitant medications included methylphenidate hydrochloride (RITALIN; lot: unknown, expiry: 28Jul2021) for attention deficit disorder and the patient takes a cocktail of anti-depressants (unspecified) for her depression. The patient received the first dose of the covid vaccine on 11Jan2021 at 3 PM and by 5PM she was experiencing bad headache, fever, L arm (injection site) pain that was severe. Later that evening she had blurred double vision and couldn't function. She also got a fever of about 100 degrees Fahrenheit, was dizzy and her eyes could not focus and were almost like double vision but not quite, it was hard to explain. She just remembered that she had a similar reaction with her eyes before, when her doctor put her on an antibiotic. She cannot recall what antibiotic that was. The patient also experienced dizziness on 11Jan2021. The patient treated her side effects with ibuprofen and most of these improved. The injection was given in her left arm, her non-dominate one. She says that the pain was so bad it woke her up, and she doesn't take any pain meds, but that was really bad. She says that she took some Ibuprofen (lot: P113671, exp: Jan2022), about a total of 800mg over a few hours. Her fever had started pretty fast, by 05:00PM on the 11th, and it was better after taking the Ibuprofen, as was her arm pain, and headache. She says that the dizziness went away probably around 02:00AM the following day (12Jan2021). She says her eyes can focus again as well. The patient thinks that these effects are medically significant, mostly that her eyes were not able to focus, it was very scary. The patient stated that the purpose of this call is to have this documented, and possibly find out if there are recommendations that she should not get the second dose, since she had to call out of work because she couldn't function. The outcome of the event ""blurred double vision and couldn't function; eyes wouldn't focus, couldn't function"" was recovered on an unspecified date and dizziness recovered on 12Jan2021 at 02:00. The outcome of the event ""she had to call out of work because she couldn't function"" was unknown while the other events were recovering. Information on the lot/batch number has been requested.; Sender's Comments: The 56-year-old female patient had medical history included attention deficit disorder; hypothyroidism and depression and she takes a cocktail of anti-depressants for this. The patient also had a similar reaction of blurred double vision and couldn't function/eyes could not focus. Based on information reported, the reported double vision and difficulty focusing eyes were more likely due to pre-existing condition (s); and less likely causally related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The rest events fever, headache, vaccination site pain and dizziness were likely causally related to the use of vaccine due to plausible temporal relationship and known safety profile of this product. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,SEN,RITALIN,,"Medical History/Concurrent Conditions: Attention deficit disorder (Ritalin; diagnosed at least 5 years ago); Blurred vision; Depression (diagnosed a long time ago, probably at least 25 year. takes a cocktail of anti-depressants for this); Hypothyroidism (diagnosed a long time ago, probably 10 years); Overweight",,,"['Condition aggravated', 'Diplopia', 'Dizziness', 'Headache', 'Injection site pain', 'Pyrexia', 'Sleep disorder', 'Vision blurred']",1,PFIZER\BIONTECH, 978851,NJ,50.0,F,"Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea; she said she was really pale, so much so, that her husband was scared for her; This is a spontaneous report from a contactable other HCP. A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left deltoid on 22Dec2020 07:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. There were no relevant medical history and concomitant medications. On to 22Dec2020, she said she feels like she has had a severe reaction to the COVID-19 Vaccine, saying she was not doing so great. Reported she received her first COVID-19 Vaccine dose on 22Dec2020 at 7:00AM in her left Deltoid. She said she had a reaction after receiving the first dose of the COVID- 19 Vaccine. She said her lips were tingling slightly, clarifying her lips were swollen too. She said she took some Benadryl (she clarified she did not have the Benadryl NDC/UPC, Lot or Expiration Date), and the Benadryl took away the lip tingling and swelling. She said she was tachypneic, and developed muscle pains (clarified as myalgia), joint pain, severe headache, weakness, and nausea. She said she also was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago, Dec2020 and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID- 19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. The outcome of the events joint pain,. myalgia, tachypnic, headache, pale and nausea was recovered on an unknown date in Dec2020; the outcome of the event tingling lips and swollen lips was recovered on 22Dec2020; while the outcome of weakness was unknown. The events were assessed as medically significant and causality was reported as related.; Sender's Comments: Based on the close compatible temporal association, there was a reasonable possibility that the events were related to the vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/22/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Asthenia', 'Headache', 'Lip swelling', 'Myalgia', 'Nausea', 'Pallor', 'Paraesthesia oral', 'SARS-CoV-2 test negative', 'Tachypnoea']",1,PFIZER\BIONTECH,OT 978852,TX,45.0,F,"joint pain/still having joint pain and muscle aches in her knees and lower legs; It is mainly irritating; still having joint pain and muscle aches in her knees and lower legs; body aches; a fever for about 3 days; feeling heaviness in her chest; She was chocking it up to anxiety; This is a spontaneous report from the contactable nurses (one is the patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration, on the right deltoid, on 04Jan2021 at a single dose as she wanted added protection (Covid-19 immunization). The patient medical history was not reported. The patient has no heart issues but has a family history of heart disease. The patient's concomitant medications were not reported. The patient was asking if it is okay to take second dose after experiencing side effects of fever, body ache, joint pain, probably anxiety, chest heaviness 8-10h after (not wheezing, 98% O2 saturation) which returned next day and subsided. On 04Jan2021, the patient got her first dose of the Pfizer COVID Vaccine, she was one of the lucky people who had joint pain, body aches, and a fever for about 3 days. She noticed about 8-10 hours after she got the vaccine that she started feeling heaviness in her chest, chest felt tight and heavy; not shortness of breath, harder to take a deep breath. She had no wheezing. In Jan2021, her oxygen level was 98%. She was chocking it up to anxiety in Jan2021. It went away. She had it the same day and the next day intermittently. It was short and passing. She is still having joint pain and muscle aches in her knees and lower legs. It is intermittent and mainly at night. She is supposed to get the second dose next Friday and asking should she go ahead and get the second dose. The joint pain had went away intermittently on Tuesday, then hit her harder on Wednesday. Thursday she felt okay but the Friday again was having the pain. It is still occurring. It is mainly at night. In the day she feels okay. It is when she lays down to relax that it kicks in. It is mainly irritating but she would say it is medically significant as it has lasted for a while, almost 2 weeks now and she is still having issues. She takes 1000mg of acetaminophen (TYLENOL) to knock it out. The heaviness in her chest lasted about 1.5 hours the first day, and then went into Tuesday intermittently. The patient recovered from anxiety in Jan2021, body aches and fever on 07Jan2021, heaviness in her chest recovered on 05Jan2021, while other events were not recovered. The reporter assessed the events of Joint pain and muscle aches in her knees and lower legs, and irritating as medically significant. The reporter causality of the events for joint pain and muscle aches in her knees and lower legs, body aches, fever and heaviness in her chest were related to the suspect drug, causality for other events was not reported. Information about lot number/batch number was requested.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of events of Joint pain and muscle aches in her knees and lower legs and irritating. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/01/2021,,UNK,,,"Medical History/Concurrent Conditions: Heart disease, unspecified (The patient has no heart issues but has a family history of heart disease)",,,"['Anxiety', 'Arthralgia', 'Chest discomfort', 'Dyspnoea', 'Irritability', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 978854,,,M,"he reported a low blood pressure episode that requires hospitalization; This is a spontaneous report from a non-contactable consumer reported for her father. A male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unknown date at SINGLE DOSE for COVID-19 immunization. Medical history and Concomitant medications were not reported. After 18 hours of the administration he reported a low blood pressure episode that required hospitalization. The outcome of the event was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,['Hypotension'],UNK,PFIZER\BIONTECH, 978855,OR,42.0,F,"auditory hallucination; This is a spontaneous report from a contactable physician (patient herself). A 42-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 28Dec2020 in left arm at single dose for covid-19 immunization. The patient medical history was not reported. The patient had taken other medications in two weeks. No other vaccine in four weeks was taken. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Facility type vaccine was hospital. The patient experienced auditory hallucination on 29Dec2020 with outcome of recovered. No treatment was received for the event.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event auditory hallucination cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,PVT,,,,,,"['Hallucination, auditory']",1,PFIZER\BIONTECH, 978856,NY,51.0,F,"metallic taste in throat; mid chest tightness and weakness; flushed feeling in body and legs; went to the emergency room since she didn't feel any better; mid chest tightness and weakness; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730, expiration date: Mar2021), via an unspecified route of administration on 30Dec2020 12:00 at single dose on deltoid left for COVID-19 immunisation. Medical history included patient was working in healthcare and around Covid positive patients daily. There were no concomitant medications. 10 minutes after getting bnt162b2, patient noticed side effects. Patient had a metallic taste in throat and a few more things. Right after getting it she had a flushed feeling in her body and legs, similar like IV contrast. 10 minutes after that so about 20 minutes later she had mid chest tightness and weakness that was gone after about 40 minutes to an hour. Patient was unable to provide any seriousness criteria, stating it was scary for a moment and she didn't know what it was, but the mid chest tightness could have progressed to something more serious. That was how she felt at that moment, but after it was all gone, it was not serious. She did not know why or what the reason was or if she was lucky or what. Patient was sitting for 10 minutes after receiving Pfizer COVID vaccine and was doing something on her phone when she started experiencing these symptoms unexpectantly. Eventually the nurses observing her after a half hour took her to the emergency room since she wasn't feeling any better. Patient had emergency room visit for all events. Outcome of events was resolving.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported mid chest tightness and the administration of the COVID 19 vaccine, BNT162B2, based on the plausible temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,Exposure to SARS-CoV-2,,,,"['Asthenia', 'Chest discomfort', 'Dysgeusia', 'Flushing']",1,PFIZER\BIONTECH, 978858,PA,38.0,F,"intense chest pain; nasal congestion; Fever; body ache; This is a spontaneous report from a contactable physician. A 38-year-old not pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular at left arm on 06Jan2021 14:00 at single dose for COVID-19 immunization. Patient had Covid prior vaccination. There were no concomitant medications. No other medications in two weeks. No other vaccine in four weeks. On 07Jan2021, The patient experienced fever and body ache for the first 2 days. On the 3rd day (19Jan2021) experienced intense chest pain and nasal congestion. she needed to go to Emergency Room where she stayed for 4 hours, and performed Thorax CT. No treatment received. The outcome of events was recovering.; Sender's Comments: Based on a compatible temporal relationship, causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,,,Medical History/Concurrent Conditions: COVID-19,,,"['Chest pain', 'Computerised tomogram thorax', 'Nasal congestion', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,OT 978859,FL,,F,"This is a spontaneous report from a contactable nurse, the patient. This nurse reported similar events for three patients. This is 1st of 3 reports. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left arm on 13Jan2021 as a single dose for COVID-19 immunization. Medical history included ongoing arrhythmias, which started about 3 years ago (2018) and got worse over time. Ongoing concomitant medications included metoprolol (MANUFACTURER UNKNOWN) taken arrythmia from Sep2020. On 13Jan2021, the patient received the vaccine. Afterwards her right wrist was itching. She took diphenhydramine hcl (BENADRYL) for the itching. Then, she felt different when she got home and was lightheaded. She also had a headache. She took acetaminophen/diphenhydramine (TYLENOL PM) before bed for the itching and headache. In the morning of 14Jan2021, she felt really bad. She did not have itching, but it started back up again later. She also took acetaminophen for the headache as the headache was on and off. She called her cardiologist due to her cardiac history, and asked if she could come in. On 14Jan2021, she had an electrocardiogram done and was diagnosed with post COVID vaccine supraventricular tachycardia (SVT). On 14Jan2021, she had head and chest congestion. She felt stuffed up. She was coughing but she had no mucus. She thought that when the arrhythmia occurred, she coughed because of the SVT. The cardiologist ordered her to wear a 24hour HOLTER monitor, the results of which were unknown. The clinical outcomes of the wrist itching and post-COVID vaccine SVT were not recovered; while the events of felt different, lightheaded, and headache were recovered on 13Jan2021. The outcome of felt really bad was recovering. The outcomes of the cough and head and chest congestion were unknown. The events of felt different, lightheaded, felt really bad, and post-COVID vaccine SVT were reported as serious for being medically significant. The seriousness of the other events was not reported.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events supraventricular tachycardia, lightheadedness and feeling abnormal. The patient's underlying arrhythmias may also predispose the patient to developing supraventricular tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021042313 same reporter, same drug and event, different patient.;US-PFIZER INC-2021042339 same reporter, same drug and event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/13/2021,0.0,WRK,METOPROLOL,"Arrhythmia (Started about 3 years ago and got worse over time, which is when she went on the Metoprolol)",,,,"['Cough', 'Dizziness', 'Electrocardiogram abnormal', 'Electrocardiogram ambulatory', 'Feeling abnormal', 'Headache', 'Nasal congestion', 'Pruritus', 'Respiratory tract congestion', 'Supraventricular tachycardia']",1,PFIZER\BIONTECH, 978862,MN,25.0,F,"broke out in hives all over her body; didn't sleep for 2 nights because she was so uncomfortable; didn't sleep for 2 nights because she was so uncomfortable; areas on her legs and ankles that are reddened; This is a spontaneous report from a contactable nurse (patient). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ1685), via an unspecified route of administration in the left deltoid, on 29Dec2020 at 18:40 (at the age of 25-years-old) as a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced broke out in hives all over her body on 03Jan2021, which was reported as medically significant. The patient also didn't sleep for 2 nights because she was so uncomfortable and areas on her legs and ankles that are reddened on 03Jan2021. The clinical course was reported as follows: The patient received her first dose of the vaccine on 29Dec2020 and said 5 days later she broke out in hives. The patient stated her hives began on the evening of 03Jan2021. She clarified she had hives all over her body and didn't sleep for 2 nights because she was so uncomfortable. She said she still had areas on her legs and ankles that were reddened. She said the reddened areas on her legs and ankles are not fully raised or itchy, like she had experienced with the hives on the rest of her body. The patient went to an urgent care on 06Jan2021. She saw a dermatologist for the hives on 07Jan2021, who suspected that since she did not have any prior history of hives, her hives are from the COVID-19 vaccine. She said the dermatologist told her there is no way to truly test if the vaccine caused her hives. The patient received an intramuscular unspecified steroid shot at the dermatologist and was prescribed methylprednisolone (MANUFACTURED BY: PAR PHARMACEUTICAL; Lot number: 1129091; Expiration date: Dec2021) 4 mg tablets in a taper dose pack. She also stated that she took the following over-the-counter medications: diphenhydramine hydrochloride (reported as: generic BENADRYL; MANUFACTURER UNKNOWN; Lot number: 0MR0456; Expiration date: Sep2022) 25 mg tablet, taken as needed; cetirizine hydrochloride (ZYRTEC; Lot number: 1652346; Expiration Date: Dec2021) 10 mg tablet, taken as one tablet up to four times a day; and hydrocortisone (MANUFACTURER UNKNOWN) cream. Therapeutic measures were taken as a result of all of the events as aforementioned. The clinical outcome of broke out in hives all over her body and didn't sleep for 2 nights because she was so uncomfortable was recovering and of areas on her legs and ankles that are reddened was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/03/2021,5.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Discomfort', 'Erythema', 'Sleep disorder', 'Urticaria']",1,PFIZER\BIONTECH, 978863,,,F,"tremor or shaking of her entire body; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient seemed to have some sort of neurological effect of causing a tremor or shaking of her entire body (hospitalization) on an unspecified date with outcome of not recovered. Date of onset of the adverse event was unknown, but the earliest that caller was aware of could be 12Jan2021, which could be the date of admission to the hospital related to this event; but event onset and hospitalization could have occurred earlier than 12Jan2021, she was not sure of exact dates. Patient age at onset was unknown but if caller had to guess probably 58 or 59 years. Height was guessed approximately 5 feet 5 inches. Weight was guessed approximately 130lbs. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Yes,,Not Reported,N,,,,UNK,,,,,,"['Neurological symptom', 'Tremor']",UNK,PFIZER\BIONTECH, 978864,,,F,"pain on her arm for over a year; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on 02Dec2019 via an unspecified route of administration in the arm at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received a pneumonia shot (unspecified trade name) on 02Dec2019 then she had been suffering with pain on her arm for over a year. The patient was seeing an orthopedic, she has had been on steroid pills, shots, done physical therapy, everything, and she didn't know the problem, why she was still hurting. The patient was concern that when that COVID vaccine, that Pfizer or Moderna, she doesn't know which she will get, but she was afraid to get the vaccine, so she was trying to find out, if there is any place else she can get it, like the butt or someplace else, she is afraid to get the shot in the arm. The vaccine was still bothering her. The outcome of the event was not recovered. Information regarding lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/02/2019,,,UNK,,,,,,['Pain in extremity'],UNK,UNKNOWN MANUFACTURER, 978866,,,U,"had lung cancer diagnosed after receiving the vaccine first dose; This is a spontaneous report from Pfizer-sponsored program . A contactable other health profession (patient's friend) reported that a patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had lung cancer diagnosed after receiving the vaccine first dose on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on known pathophysiology of lung malignancies, reported lung cancer is considered intercurrent and unrelated to suspect BNT162B2. Carcinogenesis takes years. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Lung neoplasm malignant'],1,PFIZER\BIONTECH, 978868,WA,100.0,F,"health has totally deteriorated; She sleeps, barely opens her eye; refuses to eat or drink; dizzy; didn't feel well; she can't talk, walk or anything; she can't talk, walk or anything; She is weak and frail; This is a spontaneous report from a contactable consumer (patient's daughter). A 100-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. Medical history included dementia from an unknown date and unknown if ongoing and walking aid user from an unknown date and unknown (prior to the vaccine, she walked well with her walker). Concomitant medication included quetiapine. The reporter reported that the patient's health has totally deteriorated as of a few days after receiving the vaccine on 13Jan2021. She is dying. She sleeps, barely opens her eyes and refuses to eat or drink. Three days after receiving the vaccine on 13Jan2021, she said she was dizzy and didn't feel well. Now she can't talk, walk or anything. She is weak and frail. Prior to the vaccine, she walked well with her walker, ate well and had energy. The reporter visited with her and had conversations but the patient doesn't talk or respond. She is her daughter and POA. She lives in the facility due to dementia. No treatment was received for the events. The patient did not recover from the events. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/13/2021,3.0,SEN,QUETIAPINE,,"Medical History/Concurrent Conditions: Dementia; Walker user (Prior to the vaccine, she walked well with her walker)",,,"['Aphasia', 'Asthenia', 'Diet refusal', 'Dizziness', 'Gait inability', 'General physical health deterioration', 'Hypersomnia', 'Malaise', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH, 978869,MD,44.0,F,"surface blisters, like deep blisters all over her body/blistering rash all over; Hives; Itchy tongue; Headache; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176 and expiry date: unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After receiving the vaccine, patient had hives and an itchy tongue on an unspecified date in Jan2021. Patient received some Benadryl at site. She spoke for about two hours and it seemed to ease a little bit. Patient came home and slept a quite a bit. As soon as she woke up, patient had the itchy tongue and hives again, so she took another the Benadryl. She woke up and then had a blistering rash all over on Jan2021. But the blisters were like surface blisters, like deep blisters all over her body. She went to the urgent care and received some IM steroid and Benadryl as treatment. Patient also had the headache on Jan2021. Outcome of the events was unknown. Patient was asking if she should get her second dose as back in the emergency room, they said they would not suggest to get the second dose.; Sender's Comments: Based on the time association, the blistery rash is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/01/2021,,UNK,,,,,,"['Blister', 'Headache', 'Rash', 'Rash vesicular', 'Tongue pruritus', 'Urticaria']",1,PFIZER\BIONTECH, 978870,AZ,40.0,M,"Heart event stopped him from breathing; stroke; lack of air; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm on 13Jan2021 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included nut allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included zolpidem tartrate (AMBIEN) and doxepin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jan2021 at 13:00, the patient experienced heart event that stopped him from breathing and the lack of air caused a stroke; all reported as life-threatening. On 14Jan2021, the patient underwent lab tests and procedures which included COVID-19 test which was negative. The patient was treated for the events which included being put on a ventilator and sedation. The clinical outcomes of the heart event stopped him from breathing, lack of air, and stroke, were not recovered.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,UNK,AMBIEN; DOXEPIN,,Medical History/Concurrent Conditions: Allergy to nuts,,,"['Acute cardiac event', 'Cerebrovascular accident', 'Mechanical ventilation', 'Respiratory arrest', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 978873,CA,,U,"died several hours after receiving a Covid-19 vaccine; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died several hours after receiving a Covid-19 vaccine on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The person had tested positive for the virus (Covid-19) in late Dec2020. Information on the batch/lot number has been requested.; Reported Cause(s) of Death: died several hours after receiving a Covid-19 vaccine",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Death', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 978875,NC,,M,"Fell twice and looks like he may have had a stroke; Fell twice and looks like he may have had a stroke; This is a spontaneous report from a Pfizer-sponsored program ""Pfizer First Connect"" from a contactable consumer (patient's wife). A 77-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient fell twice and looks like he may have had a stroke on 16Jan2021 with outcome of unknown. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/16/2021,1.0,UNK,,,,,,"['Fall', 'Neurological symptom']",1,PFIZER\BIONTECH, 978876,,,M,"Autoimmune disease; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse. A male patient of an unspecified age received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced autoimmune disease on an unspecified date. The patient died on an unspecified date due to autoimmune disease. It was unknown if an autopsy was performed. The information on the lot/batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. The company cannot completely exclude a causal relationship between the fatal autoimmune disease and suspect vaccine BNT162B2. Additional information regarding therapy duration, relevant medical history, underlying conditions, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.; Reported Cause(s) of Death: Autoimmune disease",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Autoimmune disorder', 'Death']",UNK,PFIZER\BIONTECH, 978877,,,F,"got the worst respiratory infection/ deathly sick; Initial information received on 23-Nov-2020 regarding an unsolicited valid serious case received from a physician and consumer or non-healthcare professional. This case involves female patient (age not reported) who experienced got the worst respiratory infection/ deathly sick (respiratory tract infection), while she received vaccine INFLUENZA VACCINE. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious got the worst respiratory infection due to which she was deathly sick for 12 long weeks (respiratory tract infection) within a week following the administration of INFLUENZA VACCINE (patient took the influenza vaccine once in his life). This event was assessed as medically significant. It was the sickest he had ever been. She will never take another flu shot. She said they are poison and that is not debatable. Then she made it a mission after that to get educated about these things like vaccines and what she found was astonishing. They have crippled and killed many caused autism, polio, nervous system disorders just to name a few by the thousands but they will always tell you they are safe. She just have one simple question that everyone should think about how in the world does it make any sense at all to inject poisons and toxins into your natural immune system as a means to stay healthy. Staying truly healthy is to not do that Laboratory details were not reported. Patient had to make three trips to the Doctor and they had to put her on three different strong antibiotics that didn't work. Finally had to be put on complete bed rest to recover. On an unknown date, the patient recovered from respiratory tract infection (patient haven't been sick again once recovered). Batch number has been requested for suspect product for this case.; Sender's Comments: A female patient (age not reported) who presented with respiratory tract infection within a week following the vaccination with INFLUENZA VACCINE (unknown manufacturer). Time to onset is compatible. Medical history, concomitant medication, precise final diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Malaise', 'Respiratory tract infection']",UNK,UNKNOWN MANUFACTURER,OT 978888,IN,61.0,F,"hemiparesis left, facial droop, weakness on left upper and lower extremity",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/18/2021,01/25/2021,7.0,PVT,,none,"HTN, DM2, s/p gastric bypass",,"bacitracin, keflex, tape, metals?","['Computerised tomogram', 'Facial paralysis', 'Hemiparesis', 'Magnetic resonance imaging']",2,PFIZER\BIONTECH,IM 978912,WA,67.0,M,"Large, bilateral, unprovoked pulmonary emboli 3 days after a Moderna first dose vaccine in a patient with no risk factors for DVT or PE and no history of any sort of pro-thrombotic disorder. He is in the hospital and work up is in progress, and so we might find another reason for his PE, but as of now we have no other explanation.",Not Reported,,Yes,Yes,,Not Reported,N,01/22/2021,01/25/2021,3.0,PVT,For Hypertension losartan potassium 100 MG Tablet (Cozaar) 1 po qd for blood pressure Chlorthalidone 25 MG Tablet 1 po q AM for blood pressure,,"Hypertension, metabolic syndrome",,"Codeine (Feels goofy), Lisinopril (Cough)","['Angiogram pulmonary abnormal', 'Echocardiogram abnormal', 'Electrocardiogram ST-T segment abnormal', 'Pulmonary embolism']",UNK,MODERNA,IM 978922,VA,73.0,M,"Received vaccine 1/19/21 at 3:30pm. Next am aches, by afternoon profuse sweating requiring clothing change. 1/21/21 woke up and had 3 watery, explosive diarrhea episodes. He fell and required 911 call. Admitted to Medical Center with diagnosis of weakness. Has had difficulty moving, and walking. on 1/27/21 still in hospital pending transfer to Rehab Center.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/19/2021,01/21/2021,2.0,PUB,Unable to collect,"Diabetes, HTN","Diabetes, HTN, following neurologist since COVID diagnosis in March 2020 due to neurological concerns that occurred with diagnosis",,Sulfa drug allergy,"['Asthenia', 'Diarrhoea', 'Fall', 'Gait disturbance', 'Hyperhidrosis', 'Mobility decreased', 'Pain']",1,MODERNA,IM 978959,CA,90.0,M,"Presented with stroke like symptoms at 10:30, right sided weakness and slurred speach. 911 was call, patient was transported to hospital. Per ED note, patient experienced TIA which resolved, actue exacerbation of CHF. Patient was admitted. Discharge summary on 1/22 indicates same diagnosis, plan was home with hospice. Family notified hospital on 1/25 that patient had expired on 1/23 at home.",Yes,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,PUB,,,,,,"['Cardiac failure congestive', 'Condition aggravated', 'Death', 'Dysarthria', 'Hemiparesis', 'Neurological symptom', 'Transient ischaemic attack']",1,PFIZER\BIONTECH,IM 978972,AZ,31.0,F,"Patient received initial COVID-19 vaccine on 1/16/2021. Experienced injection site soreness and a little fever lasting 48 hours. On 1/19/2021, patient developed severe sore throat/odynophagia. Went to an urgent care, and strep throat screen and COVID test and both resulted negative. Odynophagia continued, painful to swallow food/liquids. Never developed tongue or lip swelling. Due to ongoing fevers, patient admitted to hospital for ulcerative pharyngitis",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/16/2021,01/18/2021,2.0,WRK,desvenlafaxine 50 mg PO daily,none,none,,amoxicillin causes itchiness,"['Adenovirus test', 'Chest X-ray normal', 'Differential white blood cell count normal', 'Epstein-Barr virus antibody positive', 'Human metapneumovirus test', 'Human rhinovirus test', 'Influenza virus test negative', 'Injection site pain', 'Mononucleosis heterophile test negative', 'Odynophagia', 'Oropharyngeal pain', 'Pharyngitis', 'Pyrexia', 'Respiratory syncytial virus test negative', 'SARS-CoV-2 test negative', 'Streptococcus test negative', 'Viral test negative', 'White blood cell count normal']",1,PFIZER\BIONTECH,IM 978998,WI,89.0,F,"Day after receiving COVID 19 vaccine dose 1 admitted to hospital with fall and weakness, tested positive for COVID 19.",Not Reported,,Not Reported,Yes,,Not Reported,,01/21/2021,01/22/2021,1.0,PVT,,,,,,"['Asthenia', 'Fall', 'SARS-CoV-2 test positive']",1,MODERNA,IM 979081,CA,89.0,M,Patient found dead in home the next morning. May or may not be connected to vaccination. Instructed to report it from our medical director and director of nursing.,Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/22/2021,1.0,PVT,"Warfarin, Tamsulosin, Metoprolol, Vitamin D3, Lasix",None,"Acute systolic congestive heart failure, Atrial Fibrillation, Coronary Artery Disease, Left Ventricular Hypertrophy, Arteriosclerotic Heart Disease, Carotid Artery Stenosis, Ischemic Cardiomyopathy, Hypertension, Osteoarthritis, Myelodysplasia, COPD, Dyslipidemia, Malignant Neoplasm of Colon, Anemia",,NKA,['Death'],1,MODERNA,IM 979082,SC,76.0,F,"Severe anaphylaxis shock, received 5 drug injections at vaccination site, transported to ER for observation. released later that evening.",Not Reported,,Yes,Not Reported,,Not Reported,U,01/22/2021,01/22/2021,0.0,OTH,"clonazepam 0.5 (1), aspirin 81mg (1), centrum silver (1), miralax 1 tbsp, rosuvastatin 5 mg (1), preservision areds 2 (2), cymbalta 60 mg (1), calcium 600 +D3 (1), elderberry syrup (2) tbsp daily on all",none,fibromyalgia,,"penicillin, clindamycin, zofran, avocado","['Anaphylactic shock', 'Electrocardiogram']",1,PFIZER\BIONTECH,SYR 979101,IA,64.0,F,cardiac arrest - no warning signs,Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/25/2021,3.0,SEN,"Allopurinol, Amiodorone, Vitamin C, Budesonide, Chlorhexadine gluconate, Clonidine, Eliquis, Polyethylene glycol, Ipratopium-Albuterol, Lantus, Lasix, Loratadine, Magnesium Oxide, Melatonin, Metolazone, Metoprolol Tartrate, Nepro Carb Stea",none,"Ventilator dependant r/t acute respiratory failure with hypoxia, chronic diastolic heart failure, diabetes, cerebral infarct with hemiplegia",,"Penicillin, Chocolate",['Cardiac arrest'],1,PFIZER\BIONTECH,IM 979109,WA,66.0,F,"Unable to breath within 27 minutes, coded, rushed to emergency after crash cart medical trestment",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PVT,"Vitimin, B12,D, D3, Chewable Women's Multivitamin, Benazepril HCL, 10mg., Levothyroxine, 75MCG, Amlodipine Besylate 5 Mg, (took morning of appt) did not take prescribed mef of Dextroamp Amphetamine 10 mg or 20 mg that day.","Graves Disease, anemia, foot fungus, wart removed, anxiety","Graves Disease, Anxiety, one, prior treatment for migraines with Botox 2O13 after 20 years of illness, minor asthma treatment PRN, cognitive issues as a result of 3 motor vehicle accident, Sleep Apnea, untreated, Narcolepsy ( untreated), periodic psycological treatment for episodic events in life; i.e, divorce, legal issues, family dynamic, childhood sexual and mental abuse",,"Sulfur, sulfates, peanut butter, milk, coconuts, penicillin, amoxicillin, reglan, vicodin, latex, codeine, morphine","['Blood test', 'Cardio-respiratory arrest', 'Respiratory arrest', 'Resuscitation']",UNK,PFIZER\BIONTECH, 979121,NY,31.0,F,EST. date of my delivery is 5/11/2021 30 hours after the dose had adnominal pain. Several episode of diarrhea. Also had nausea and chills.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,None,None,None,,None,"['Abdominal pain', 'Chills', 'Diarrhoea', 'Exposure during pregnancy', 'Nausea']",1,PFIZER\BIONTECH,IM 979136,MN,60.0,F,ER ROOM........... DIAHARREA AM 600PM TO 300 AM VOMITING SAME TIME HEADACHE ER ROOM 1100 AM,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/20/2021,01/21/2021,1.0,SEN,NONE,NONE,NONE,,PENICILLIN,"['Blood test', 'Diarrhoea', 'Headache', 'SARS-CoV-2 test', 'Ultrasound abdomen', 'Ultrasound bladder', 'Urine analysis', 'Vomiting']",1,MODERNA,IM 979143,,56.0,M,"Patient was hospitalized on 1/24/2021 with COVID-19. He reports symptoms started on 1/18/21, 7 days prior to admission, and 11 days after receiving his first dose of the Pfizer/BioNTech COVID19 Vaccine. During this time he experienced shortness of breath and non-radiating, pressure-like chest pain, the latter prompting him to go to the Emergency Department. Upon admission his oxygen saturation was 90% and was put on 2 L nasal cannula with oxygen saturation, increasing oxygen saturation to 95%. On 1/26/2021 oxygen was increased to 4 L nasal cannula with oxygen saturation at 94%. On 1/27/21 oxygen requirements improved and pt is now on 2 L nasal cannula with oxygen saturation at 99%.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/07/2021,01/18/2021,11.0,UNK,,,"CAD, T2DM, Hyperlipidemia, Hypothyroidism, Obstructive Sleep Apnea, prior CVA, Erectile Dysfunction, Obesity",,,"['COVID-19', 'Chest discomfort', 'Chest pain', 'Dyspnoea']",1,PFIZER\BIONTECH,IM 979151,NY,77.0,M,"Patient received unknown covid vaccine 1/20/21, sometime before or after became Covid PCR+. 3 days later developed encephalopathy, was quite agitated, walking around hospital naked. He had LP which ruled out infection and CT imaging to rule out CVA. Improved after 24 hrs with supportive care, pt returned to mental status baseline",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/20/2021,01/23/2021,3.0,UNK,pravastatin,"lymphoma,","prostate ca, lymphoma, CKD stage 3",,none,"['Abnormal behaviour', 'Agitation', 'CSF test normal', 'Computerised tomogram head normal', 'Encephalopathy', 'Lumbar puncture', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 979155,AZ,65.0,M,"Jan 3 vaccine administered, jan 4 started headaches, vomiting, pain in the back of the neck, Headaches, chills, loss of speech,",Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,SEN,"Atrovastatin Calcium 80mg, Cholecalclfer0l Tablet 5000 Unit, Clopidogrel Bisulfate Tablet 75 mg, Colace Capsule 100 mg, Cyanocobalamin tablet 1000 Mcg, Famotidine Tablet 20mg, Gilmepiride Tablet 1 mg, Loperamide HCI Capsule 2Mg, Melatonin T",,"Heart Disease, Polyneuropathy, Anemia and chronic Kidney disease, Type 2 Diabetes, hypotension",,,"['Aphasia', 'Chills', 'Headache', 'Influenza A virus test positive', 'Neck pain', 'Vomiting']",UNK,PFIZER\BIONTECH,UN 979210,CA,56.0,F,"Acute onset of diverticulitis late afternoon/evening after injection without usual prodrome of symptoms. Initial onset of LLQ abdominal to suprapubic pain about 4 hours after injection on 01/19/21, later that night chills, fever of up to 100.4� with worsening abdominal pain 8/10. On 01/20/21 App used for video MD visit prescribed Augmentin 875/125, started later that day. In bed 22 of 24 hours on 01/20/21 and 01/21/21. Acute onset of non-traumatic R ankle /foot severe swelling and instability with severe pain, unable to bear weight, waking me up early morning 01/22/21. Due to diverticulitis and unable to walk, stayed home, conservative care (RICE), ace bandage and Norco 5 mg 01/22/21-01/24/21. X-rays R ankle/foot taken on 01/25/21 at Imaging . Unable to get into PCP, went to Urgent Care, orthocast placed, prescribed Norco 5 mg. Unable to talk with PCP, spoke with another Physician requesting MRI R foot/ankle and Podiatry and/or orthopedic Consult. Still non-weight bearing on 01/27/21 but decreased swelling and R ankle/foot pain in cast. Diverticulitis improved, no fever, on liquid diet.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/19/2021,01/19/2021,0.0,OTH,"Lotrel 5/20 mg, levothyroxine 25 mcg, Nature's Made Diabetes Supplement Pack",R calcaneal stress fracture,"Hypertension, hypothyroidism, diverticulosis w occasional bouts of diverticulitis, obesity.",,"Sulfa Antibiotics, Dilaudid","['Abdominal pain lower', 'Arthralgia', 'Cast application', 'Chills', 'Condition aggravated', 'Diverticulitis', 'Gait inability', 'Joint instability', 'Joint swelling', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Sleep disorder', 'Suprapubic pain', 'Weight bearing difficulty', 'X-ray limb']",1,MODERNA,IM 979223,CA,77.0,M,Patient developed SOB but reported good O2Sats. Instructed on going to ER if worsening symptoms. Patient eventually expired on 1/22/21,Yes,01/22/2021,Not Reported,Yes,,Not Reported,N,01/05/2021,01/12/2021,7.0,OTH,"Pravastatin 40 mg, KCL ER 10meq, Metoprolol 25 mg, losartan 100 mg, glyburide 2.5 mg, furosemide 40 mg, ASA 81 mg, amlopidine 10 mg, allopurinol 300 mg","CHF, hypertension, type 2 DM",same as 11,,NKA,"['Death', 'Dyspnoea']",1,MODERNA,IM 979224,MN,88.0,F,Pt. with weakness and GI bleed. Admitted to hospital after being seen in the ER,Not Reported,,Yes,Yes,,Not Reported,N,01/07/2021,01/26/2021,19.0,PUB,Too many to list.,None other than chronic illness,"Afib on coumadin, HTN, hyperlipidemia, osteoporosis",,Ambien and cyclobenzoprine,"['Asthenia', 'Full blood count', 'Gastrointestinal haemorrhage', 'Metabolic function test']",UNK,MODERNA,IM 979255,CA,65.0,M,"Patient received COVID 19 vaccine the morning of 1/18/21 at Public Health COVID-19 vaccine clinic. I (person completing this report) work for PH. Later that night while in bed, patient reported difficulty breathing to his wife, then turned blue, and became unresponsive. Family report pt was without any symptoms prior to event. 911 called; CPR started by family member 15 min. after pt became unresponsive. EMS performed resuscitation for about 30-40 minutes with multiple defibrillation for V-fib. Between EMS and Medical Center ER, pt had 9 rounds of epi, CPR w/ LUCAS machine, given 2 doses of amiodarone (150 mg and 300 mg). Patient had 3 EKGs, which did not show STEMI, but did show nonspecific conduction delay and sinus arrest with junctional escape vs sinus bradycardia (HR 50's). Pt had return of spontaneous circulation. Pt intubated, and started on Levophed. Pt transferred to ICU, and had central line placed. Family decided to make patient DNR. Pt went into coarse VFib again, and as per wishes of family, code blue not called. Patient expired at 01:53 on 1/19/21.",Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/18/2021,0.0,PUB,"per hospital list: Nitrostat 0.4 mg SL prn, famotidine 10 mg, ASA 81 mg, atorvastatin 20 mg, benazepril 5 mg, carvedilol dose unspecified",unknown; family report pt without symptoms prior to event,"hx of gastric bypass; s/p CABG 3 years ago, HTN, HLD, morbid obesity",,none; + bee allergy listed in records,"['Angiogram pulmonary abnormal', 'COVID-19 pneumonia', 'Cardiomyopathy', 'Cardioversion', 'Central venous catheterisation', 'Chest X-ray abnormal', 'Conduction disorder', 'Cyanosis', 'Death', 'Dyspnoea', 'Echocardiogram abnormal', 'Ejection fraction decreased', 'Electrocardiogram abnormal', 'Endotracheal intubation', 'Hiatus hernia', 'Intensive care', 'Lung consolidation', 'Lung opacity', 'Metabolic acidosis', 'Myocardial necrosis marker normal', 'Nodal rhythm', 'Oesophageal disorder', 'Pneumonia aspiration', 'Resuscitation', 'Scan with contrast abnormal', 'Sinus arrest', 'Sinus bradycardia', 'Unresponsive to stimuli', 'Ventricular fibrillation']",1,PFIZER\BIONTECH,IM 979257,KY,65.0,F,Notified by a secondary source the following information. Patient was admitted to the hospital for a stroke. The hospital discovered the patient had a stroke a week prior to vaccination. Patient pace maker had been faulty and patient INR may have been lower than therapeutic. Unable to speak directly to patient at this time to confirm these events. Actual progression unknown. Understood patient is improving.,Not Reported,,Not Reported,Yes,,Not Reported,Y,01/20/2021,01/21/2021,1.0,OTH,"Warfarin, Levothyroxine, Zocor, Losartan, B12 1,000, Lopressor, Flecainide",unknown,"Bradycardia, High Blood pressure, High Cholesterol, possible Lung issues no known Drug Allergies",,,"['Cerebrovascular accident', 'Complication associated with device', 'International normalised ratio']",1,PFIZER\BIONTECH, 979259,FL,82.0,F,"At 8:00 P.M. that night she used her walker to go to the bathroom. After 5 minutes I went in and found her walker at the comode,and she was standing 20 ft. away at the bed mumbling O.K. o.k. and that was all she said. I called 911 and she was taken to The Hospital where she is currently in ICU on a respirator.",Not Reported,,Yes,Yes,5.0,Yes,N,01/22/2021,01/22/2021,0.0,PVT,Tylenol,Lung Cancer and Biopsys done on Tues Before,Fell broke right hip in Sept 2020 Found mass on Left lung Negative.Right lung biopsied at Hospital.,,None,"['Intensive care', 'Mechanical ventilation', 'Speech disorder', 'Walking aid user']",2,MODERNA,SYR 979264,FL,,F,"Patient was given vaccine @ 10:47am, sat in observation area for about 20 minutes then reported sore throat (of sudden onset) EMS was on site and attend patient. Patient reports history of anaphylaxis x 3.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/27/2021,01/27/2021,0.0,PUB,"Metoprolol Amitiza Gabapentin Eliquis, Diltiazem, Topiramate",pacemaker (afib) Hx seizures,"hypertension, neuropathy",tetanus ? dyspnea ? anaphylaxis,"tetanus, codeine, Latex",['Oropharyngeal pain'],UNK,MODERNA,IM 979288,FL,82.0,F,Shortness of breath EMS on scene and treated the client. *Epi given @ scene by EMS.,Not Reported,,Not Reported,Yes,,Not Reported,U,01/27/2021,01/27/2021,0.0,PUB,"HTN, cholesterol, Inhaler -> Daily to BID",0,,,0 NKDA,['Dyspnoea'],UNK,MODERNA,IM 979309,NV,51.0,F,Systemic: patient had no known medical history per supervisor,Yes,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,SEN,,,,,,['Death'],1,PFIZER\BIONTECH,IM 979315,,72.0,M,"Patient received the first dose of the Moderna COVID19 Vaccine on 1/8/21. He reports he had a sore arm for about 2 days, but soon after developed shortness of breath, generalized body aches and extreme fatigue, most of which lasted for 6 to 7 days. The shortness of breath worsened during this time and he also developed a bump in the right neck area. Upon admission his oxygen saturation was 91% and he had a 10 L nasal cannula placed, increasing saturation to 93%. As of 1/27/21, oxygen saturation has improved and pt is now on 5 L nasal cannula, saturating at 99%.",Not Reported,,Not Reported,Yes,3.0,Not Reported,,01/08/2021,01/10/2021,2.0,UNK,,,"Hypertension, diverticulosis with prior diverticulitis, pancreatitis",,,"['Dyspnoea', 'Fatigue', 'Pain', 'Pain in extremity', 'Swelling']",1,MODERNA,IM 979316,MT,54.0,F,"Patient reported tight coughing and itching to lips. Vital signs remained stable. SPO2 99-100% on room air. Medicated with racemic epinephrine, solumedrol, pepcid, benadryl. Patient denies any improvement in her symptoms. Monitored overnight as an observation patient. Was then discharged the next day to home.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/20/2021,01/20/2021,0.0,PVT,"Ropinirole, Ondansetron, Meloxicam, Levothyroxine, Estradiol, escitalopram, Cetirizine, Benadryl, Wellbutrin, Hydrocodone, Aspirin",Had Right Shoulder arthroscopy on 12/15/20,"Fibrocystic breast disease, myopia, presbyopia, obesity, depression, hypertension, acquired hypothyroidism, neuropathy, smoke inhalation, knee pain",Influenza,"Albuterol, Codeine, Levaquin, Penicillin, Tramadol, Sulfa, Hydrocodone, Chinese Food, Influenza, Sweet grass, dust from cereal grains","['Cough', 'Lip pruritus']",2,MODERNA,IM 979325,,69.0,F,"HPI: 69 y/o woman with minimal PMH of hysterectomy and cystic mass resection in 2016. She presented with c/o fatigue, fevers, shaking chills, SOB/cough, anorexia, N/V/D for the past 6 days (GI symptoms started 2 days ago). Husband reports she has also had periodic confusion during this time. She received her second COVID vaccine 7 days ago and symptoms started the following day.",Not Reported,,Not Reported,Yes,13.0,Not Reported,N,01/08/2021,01/09/2021,1.0,UNK,"Vit D, Calcium, Tylenol, Motrin",,,,none,"['Chills', 'Confusional state', 'Cough', 'Decreased appetite', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Nausea', 'Pyrexia', 'Vomiting']",UNK,PFIZER\BIONTECH, 979326,MI,35.0,F,"I had extreme dry eye (both eyes) and previous ablation right occurred 3-6 months earlier.I went on 12/31 I had to get eye drops. Throughout the evening I started to exp pain left continuously eye drops and ice pack. The next morning 1/1 woke up pain was still there went to urgent care. I was told the tissue was reopened from the ablation given antibiotic drops to take 4 drops, Erythromycin and follow up 2 days. I was told to up dosage to 6 drops due to bacteria,recommended to follow up with Opthamologist in April 2021.",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/29/2020,12/31/2020,2.0,PUB,No,No,Low back pain,,No,"['Dry eye', 'Eye disorder', 'Eye infection bacterial', 'Eye pain']",1,MODERNA, 979379,VA,62.0,M,"19th vaccinated; my wife was exposed to COVID on 26th and she developed symptoms on 29th; I developed on 31st and tested Positive on January 2 for COVID; January3, I was admitted to ER for shortness of breath, my oxygen saturation - between 88 and 94; I was in the hospital and discharged on January 8. Remdesivir and Decadron treated with and also Eliquis. I was on oxygen until Wednesday (three days) and then I went home on 8th and continued on Prednisone for last week (Friday). Haven't gone back to work - shortness of breath, fatigue and headaches continue.",Not Reported,,Yes,Yes,6.0,Not Reported,N,12/19/2020,12/31/2020,12.0,OTH,Losartan 50 mg daily; Zocor 20 mg daily; aspirin - 81 mg daily; Breolopto inhaler daily; Mybetriq - 50 mg daily; Vit D - 5000 units daily,none,hypertension; high blood pressure; obesity; asthma,MMR -rash 1980,none,"['Angiogram pulmonary abnormal', 'Blood test', 'Chest X-ray', 'Dyspnoea', 'Exposure to SARS-CoV-2', 'Fatigue', 'Headache', 'Impaired work ability', 'SARS-CoV-2 test positive', 'Thrombosis']",1,PFIZER\BIONTECH,IM 979451,ME,61.0,F,"Pt received second dose of vaccine and went to the observation area. She was risk stratified into the high risk (30 minute obsevation) category based on a previous anaphylactic response to shelffish requiring epinhephrine. She reported only a minor pruritis after the first dose of the vaccine. While in the observation area she reported auditory exclusion to her male partner, then reportedly went unconcsious immediately. Employees working in the observation area were notified and summoned medical assistance. A medical provider (PA) arrived and found the pt supine in the passenger seat and unresponsive. Her pulse was weak and thready. One dose of 0.3mg epi autoinjector was administered to her R lateral thigh at 12:03p",Not Reported,,Yes,Not Reported,,Not Reported,U,01/21/2021,01/21/2021,0.0,OTH,,,,,"Moderate to severe reaction to mollusks: clams, mussels, etc.","['Deafness', 'Loss of consciousness', 'Pruritus', 'Pulse abnormal', 'Unresponsive to stimuli']",1,MODERNA,IM 979461,NY,54.0,M,The patient lives in a group home. He has a history of seizures with occasional breakthrough. On 1/24/22 at ~4 am he had a cluster of seizures and a fever of 102.0F. The staff called 911 and he was taken to the Hospital and admitted for observation. All the details of the hospitalization and treatment are not known now. His group home staff person who was at the hospital with him reported that he was back to his baseline after 1 day. He remained in the hospital for video EEG monitoring. The studies will be reviewed by neurology to determine if medication changes are needed. His discharge is planned for tomorrow (1/28/2021).,Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/22/2021,01/24/2021,2.0,OTH,"Fycompa, Keppra, Vimpat, Olopatadine ophthalmic, Colace, Ketoconazole shampoo, ducolax, folic acid, multivitamin, Oscal plus D","ER Visit 1/11/2021 for cluster of seizures,","Seizure disorder, osteoporosis, ataxia, old cerebral infarct, profound intellectual disability, dysphagia",,none known,"['Condition aggravated', 'Electroencephalogram', 'Pyrexia', 'Seizure cluster']",1,MODERNA,IM 979465,NY,73.0,F,"Injection site pain, Nausea, light headed same day (1/25//2021) after injection. That evening, Nausea, fever and chills. Took Tylenol. Next day (1/26/2021) Nausea, fever and chills continued. On 1/27/2021 in the morning became faint and weak and fell or fainted. Due to fall hit her head. Daughter living in same house treated her with Ice Pack and brought her to Hospital ER for evaluation. Hospital identified fever and began antibiotic treatment and fluids.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/25/2021,01/25/2021,0.0,PVT,"Metoprolol, Metformin, Lisinopril, Aspirin 81mg, Lovastatin, Vitamin D 2000IU",None,"Post Bypass, HTN, Diabetes",,None,"['Asthenia', 'Blood lactic acid increased', 'Chills', 'Dizziness', 'Fall', 'Head injury', 'Injection site pain', 'Nausea', 'Pyrexia', 'Syncope']",1,MODERNA,IM 979495,WY,83.0,M,No adverse events noted Patient past away was notified by Public Health the record is at Vital Statistics,Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,N,,01/19/2021,,PVT,Budesonide/formoter Fish Oil Aspirin Albuterol Terazosin Potassium Pantoprazole Metoprolol Metolazone Levothyroxine Furosemide Alopurinol Apixaban Lactobacillus Acidophilus,,MRSA carrier CHF Gout Vitamind deficiency A fib,,Amiodarone Mild Pulmonary fibrosis,['Death'],1,MODERNA,IM 979533,AZ,82.0,F,Patient recieved vaccine 1 of covid 19 i 1/19/2021. She felt poorly on 1/20/2021. She felt dizzy and fell at 3 AM on 1/23/2021. She felt poorly and did not know her son's name which was not normal. She went to ER on 1/24. She was assessed as not having fractures. She was going to be transferred to a skilled nursing facility. She was not having respiratory complaints. She was awaiting transfer when her O2 levels started dropping substantially. She declined aggressive intervention and she died within a few hours.,Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/20/2021,1.0,OTH,"dexamethasone, losartan, amlodipine, Ensure supplement drink",chronic copd is stable condition; no illnesses at time of vaccination,copd hypertension,,none,"['Chest X-ray normal', 'Death', 'Dizziness', 'Fall', 'Feeling abnormal', 'Laboratory test normal', 'Memory impairment', 'Oxygen saturation decreased', 'SARS-CoV-2 test negative', 'X-ray of pelvis and hip normal']",1,MODERNA,IM 979539,CA,51.0,F,"Pt received Pfizer vaccine 2nd dose on 1/11/2021. On 1/12/2021, pt had severe lower back seen her PCP and lower back pain progressed on 1/18/2021. Employee went to ER and was discharge. She continued to have back pain and went ER on 1/24/2021, she was admitted and doctor related her symptoms/neuropathy to the COVID vaccine, per employee. On 1/24/2021, admitted to Hospital for treatment included CT scan, MRI scan, medication such as morphine, dulaudid, Norco and gabapentin. Current using a walker for stability.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/11/2021,01/12/2021,1.0,WRK,unknown,unknown,unknown,,unknown,"['Back pain', 'Computerised tomogram', 'Gait disturbance', 'Magnetic resonance imaging', 'Neuropathy peripheral', 'Walking aid user']",2,PFIZER\BIONTECH,IM 979594,,80.0,F,"Patient observed slumping over in chair. When assessed she stated she felt lightheaded and was diaphoretic. Blood pressure obtained at 1400, BP 63/34, HR 84. EMS contacted and dispatched. Patient experienced syncope. 1405 EPI administered per protocol. 1414 vital signs as follows: BP, 168/135; HR 60.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,OTH,,,,,,"['Blood pressure abnormal', 'Dizziness', 'Hyperhidrosis', 'Syncope']",UNK,PFIZER\BIONTECH,IM 979630,NJ,46.0,F,"blood clot in lungs, PE,",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/11/2021,01/15/2021,4.0,PUB,"atenelol 25 mg, topiramate, singulair 10mg",,"svt, sleep apnea, asthma",,"eletriptan, cantaloupe, cats","['Blood test', 'Computerised tomogram', 'Pulmonary embolism', 'Thrombosis', 'Ultrasound Doppler', 'Ventilation/perfusion scan']",1,MODERNA,IM 979666,MA,60.0,M,0900 - Pfizer Shot 1000- noticed eyes looked puffy 1100- rash started on left arm below bicep in the elbow area 1115- rash now showing on right arm in the same area Around 1230 - 1300 seen by EMT - at that time I was given a shot of Epinephrine and IV of Benadryl transported by ambulance to ED to be evaluated for allergic reaction. was released from the ED around 1545 no other treatment needed,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/22/2021,01/22/2021,0.0,WRK,Metformin Ezetimibe Atorvastatin vitamin D Tramadol as needed for back pain. note maybe 1 pill every other day,,,,Azithromycin Cat dander,"['Injection site rash', 'Periorbital swelling', 'Rash']",1,PFIZER\BIONTECH,IM 979690,AZ,50.0,M,"Acute appendicitis with perforation on January 17, 2021 that required emergency surgery",Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/14/2021,01/16/2021,2.0,PVT,"Vitamin D 5,000 IU every day Ibuprofen 200 mg PRN headache (about 1 or 2 a month) Tadalafil 5 mg PRN",None,None,,None known,"['Appendicitis', 'Appendicitis perforated', 'Computerised tomogram abdomen abnormal', 'Surgery', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 979709,,56.0,M,Pt passed away 1/23/2021. Exact details unknown.,Yes,01/23/2021,Not Reported,Yes,9.0,Not Reported,N,01/06/2021,01/11/2021,5.0,OTH,ZOLOFT 25 MG QD COREG 12.5 MG BID IMDUR 30 MG QD CALCIUM ACETATE 667 MG QID HEPARIN QHD MIRCERA Q4W FERRLECIT 125 MG TIW,NONE,"RENAL OSTEODYSTROPHY, ACUTE KIDNEY FAILURE, ENDOCARDITIS, GOUT, DEPRESSION, CHF, TACHYCARDIA, TOBACCO USE, HYPERTENSION",,PCN,['Death'],1,MERCK & CO. INC.,IM 979716,IL,74.0,F,"the patient received the vaccine on 1/8/21, her last day of work was on 1/11/21, patients family reported that she was hospitalized and on life suppose on 1/12/21. She suffers from severe asthma, has several asthma attacks and wound up on the life suppose. Patient passed away on 1/22/21",Not Reported,,Not Reported,Yes,10.0,Not Reported,N,01/08/2021,01/11/2021,3.0,SEN,"ALBUTEROL HFA INH, AMLODIPINE 10MG, MONTELUKAST 10MG, SPIRONOLACTONE 50MG, ATORVASTATIN 20MG, MONTELUKAST 10MG. OTC, HERBALS, AND DIETARY SUPPLEMENT UNKNOWN.",ASTHMA,ASTHMA,,ALLERGY TO SALICYLATES ONLY ON FILE.,"['Asthma', 'Condition aggravated', 'Death', 'Life support']",1,PFIZER\BIONTECH,IM 979767,ID,73.0,F,Moderna COVID- 19 Vaccine EUA was given on 12/29/20 and patient was hospitalized on 1/11/21 with COVID-19 and was released on 1/16/21 after receiving remdesivir and dexamethasone.,Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,12/29/2020,01/07/2021,9.0,PVT,"ASPIRIN 81MG EC, CEPHALEXIN 500 MG ORAL CAPSULE, CHOLECALCIFEROL (VIT D3) 5,000 UNIT, HYDROCORTISONE 1% CREAM, INSULIN NOVOLIN 70/30 (NPH/REG) INJ, LATANOPROST 0.005% OPH SOLN , LOSARTAN/HCTZ 100MG/12.5MG, METFORMIN HCL 1000 MG ORAL TA",Moderna COVID- 19 Vaccine was received on 12-29-20 and patient was admitted to hospital with difficulty breathing and found to have COVID 19 infection. patient was treated with dexamethasone and remdesivir and released from hospital on 1/16/21,"DM, Anxiety, recurrent vaginitis, bursitis, HTN, hyperlipidemia",,"Codeine, sulfa, cipro, neo/poly/HC, nitrofurantion","['COVID-19', 'Dyspnoea', 'SARS-CoV-2 test']",1,MODERNA,IM 979773,TX,75.0,F,Not sure if it has to do with the COVID vaccine but her caregiver reported to me today (1/27/20201) that she passed away on 01/16/2021 from a pulmonary embolism that was 18 days after vaccine,Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/16/2021,17.0,SEN,none as far as i know,none per care giver,none that was reported,,none reported,"['Death', 'Pulmonary embolism']",1,MODERNA,IM 979796,TX,74.0,M,Patient went to hospital with COVID symptoms on 01/10/2021 and passed away on 01/22/2021,Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/10/2021,2.0,PHM,"metoprolol, atorvastatin, furosemide, metformin, trulicity, glipizide, omeprazole, gabapentin, loratadine, losartan, amlodipine","not known. I spoke with his wife when he was in the hospital a couple of days after the first dose of Moderna vaccine. She mentioned that he felt ill a few days before and up to the vaccine date. Despite feeling ill, he checked off ""no"" on the questionnaire section that asked if patients were feeling ill that day.","Diabetes, hyperlipidemia, hypertension",,none,['Death'],1,MODERNA,IM 979818,TX,77.0,M,"Patient arrived at ER with complaints of CPR in progress. Per EMS, patient became short of breath while performing yard work on 1/26/2021. At arrival, patient was in fine v fib with a total of 6 shocks delivered along with 300 mg amiodarone followed by 150 mg amiodarone, 1 amp epinephrine and 2 epinephrine drips adminstered en route to ED. CPR initiated at 1755 and EMS reports asystole at 1829. TOD 1909 pronounced by ED DO Dx: Cardiac arrest",Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,PVT,Adult one daily multivitamin Vitamin B12 Vitamin D Acetaminophen - Codeine 300-30 prn acyclovir levothyroxine,"Malignant neoplasm of colon dx Stage IIB in 2018. Surgery in 2018 to remove mass Inguinal hernia (rt) CT follow up in 12/2020 r/t above found no evidence of metastatic disease in abdomen or pelvis, inguinal hernia still present. Distension in abdomen reported in 11/2020 through 12/2020 at office visit","Malignant neoplasm of colon dx Stage IIB in 2018. Surgery in 2018 to remove mass Inguinal hernia (rt) CT follow up in 12/2020 r/t above found no evidence of metastatic disease in abdomen or pelvis, inguinal hernia still present.",,None,"['Cardiac arrest', 'Cardioversion', 'Death', 'Dyspnoea', 'Resuscitation', 'SARS-CoV-2 test positive', 'Ventricular fibrillation']",1,PFIZER\BIONTECH,IM 979837,NV,76.0,M,"Per EMS, the patient was last seen walking and talking to wife 10 minutes prior to EMS arrival. EMS reports via patients wife, that patient was upstairs to change for his doctor appointment then patient's wife found him down. The patient received his COVID-19 vaccine on 1/25/21. EMS states they gave 5 rounds of EPI then patient moved into vfib then was shocked once but returned to asystole. In ED, the patient initially in asystole CPR was started immediately. The patient was given 3 rounds EPI, 1 round bicarb. The patient stayed in PEA throughout. Patient was given tPA. Patient continued to be in asystole and time of death was called at 11:35 am.",Yes,01/27/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/27/2021,2.0,PVT,,"History of benign prostatic hyperplasia, hypertension, urinary tract infection, cerebrovascular accident. 1/25/21 Brought to Hospital ED by EMS from Health District for near syncope and hypotension post Pfizer vaccine administration. 1/27/21 Brought to Hospital ED by EMS from home after wife found.","History of benign prostatic hyperplasia, hypertension, cerebrovascular accident.",,No known allergies,"['Cardiac arrest', 'Cardioversion', 'Death', 'Hypotension', 'Presyncope', 'Pulseless electrical activity', 'Resuscitation', 'Ventricular fibrillation']",UNK,PFIZER\BIONTECH, 979841,MT,64.0,M,"Pt likely presented to vaccine appt with asymptomatic/early infection of COVID-19, as he presented 2 days post-vaccination and tested positive for COVID-19 on rapid and PCR test. He was hospitalized where he eventually died of complications from COVID-19 while in ICU. Date of death was 1/15/2021.",Yes,01/15/2021,Not Reported,Yes,6.0,Not Reported,,01/07/2021,01/09/2021,2.0,PVT,,"Evaluated for L flank pain in ED on 1/1/2021, no acute findings on CT. Noted to be in mild CHF, discharged home from local ED.","HTN, CKD stage 5, hemodialysis dependent, DM type II, hx renal transplant",,,"['COVID-19', 'Death', 'Intensive care', 'SARS-CoV-2 test positive']",1,MODERNA,IM 979886,AR,42.0,F,"Moderna COVID-19 Vaccine Extreme Fatigue, Joint pain, Body pain, low grade fever of 99.3 -100.4, loss of appetite, Headaches, unable to sleep, mouth sores, swollen lymph nodes, brain fog (Dizzy headed)",Not Reported,,Not Reported,Not Reported,,Yes,N,01/08/2021,01/08/2021,0.0,WRK,Hydrochlorothiazide 25MG once daily AzaTHIPprine 150MG once daily,None,"undifferentiated convective tissue disorder, Lupus, Hashimoto thyroid-ism, Celiac disease, Crest syndrome,Fibromyalgia, osteoarthritis",,"Penicillin, K flex, sulfa drugs, codeine, gluten, coconut, avocado","['Arthralgia', 'Blood test normal', 'Chest X-ray normal', 'Decreased appetite', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Headache', 'Influenza virus test negative', 'Insomnia', 'Lymphadenopathy', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Stomatitis', 'Urine analysis normal']",1,MODERNA,SYR 979926,CA,81.0,F,Pt began experiencing shortness of breath 3 days after vaccine and expired later that day.,Yes,01/02/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/02/2021,3.0,SEN,,"Pt was on hospice in LTCF at time of death, but expired 3 days after receiving vaccine. She exhibited shortness of breath the morning of death. 12/7-12/17 covid positive but seemed to be recovering HTN Alzheimer?s",HTN Health Conditions,,,"['Death', 'Dyspnoea']",1,PFIZER\BIONTECH,IM 979937,WA,38.0,F,"G3P1011 at 19wks EGA given Pfizer Covid-19 vaccine 17 days after first in series. Within 24 hours of administration, developed fevers exceeding 104 degrees (104.7 max, tympanic), tachycardia to 130s, rigors with fevers not responding to maximal doses of oral acetaminophen and ibuprofen, requiring hospital admission for IV fluids and IV antipyretics and anti-inflammatory agents.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/21/2021,01/22/2021,1.0,MIL,"Prenatal vitamin, Aspirin 81mg",None,Cardiac arrhythmia,,None,"['Chest X-ray normal', 'Chills', 'Electrocardiogram abnormal', 'Exposure during pregnancy', 'Full blood count abnormal', 'Neutrophilia', 'Pyrexia', 'SARS-CoV-2 test negative', 'Sinus tachycardia', 'Tachycardia']",2,PFIZER\BIONTECH,IM 979990,OH,63.0,M,sudden cardiac arrest,Yes,01/09/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,PVT,,none,,,NKDA,['Cardiac arrest'],UNK,MODERNA, 980009,VA,43.0,U,"Swollen throat, not able to swollow or breath Chili?s dizziness , shaking, coughing , feeling like being choked Epipen, benedryl howpitalization",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,SCH,None,None,None,,None,"['Chills', 'Choking sensation', 'Cough', 'Dizziness', 'Dysphagia', 'Dyspnoea', 'Pharyngeal swelling', 'Tremor']",UNK,MODERNA,SYR 980020,MO,62.0,M,"1/25/2021- Presented to ED with chest pain which radiated up his right shoulder, right armpit and across his chest. The EKG showed a STEMI [acute inferior]. He was transferred to other Hospital.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/08/2021,01/25/2021,17.0,PVT,Glucotrol 10mg; metFormin XR 500 mg,,Hypertension and Diabetes,,,"['Acute myocardial infarction', 'Arthralgia', 'Axillary pain', 'Chest X-ray', 'Chest pain', 'Electrocardiogram abnormal', 'Laboratory test', 'Pain']",UNK,PFIZER\BIONTECH,IM 980049,NY,35.0,F,"Blue dots around injection site, swelling, redness, pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/27/2021,2.0,UNK,Aspirin 81mg daily Levothyroxine 137mcg daily Tylenol 1000mg as needed for fever,None,Hypothyroid HSV Type 2,,Demerol - itching,"['Injection site discolouration', 'Injection site erythema', 'Injection site pain', 'Injection site swelling']",2,PFIZER\BIONTECH,IM 980056,AZ,76.0,F,"Rash and severe swelling of the face, Hands and throat. Given intravenous benedryl, Pepcid, Ativan, Prednisone",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,OTH,Lotsartan,None,None,Contrast dye,Contrast dye,"['Hypersensitivity', 'Peripheral swelling', 'Pharyngeal swelling', 'Rash', 'Swelling face']",1,PFIZER\BIONTECH, 980074,IL,36.0,F,"patient had her jaw clenched and her upper body contracted, with partial seizure of the upper body, with difficulty breathing. her pulse ox was 86 %. she was given a shot of epinephrine and immediately recovered with pulse ox up to 98%. She was taken to the ER by EMS",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/27/2021,01/27/2021,0.0,PVT,none,none,asthma,,nkda,"['Blood glucose normal', 'Bruxism', 'Dyspnoea', 'Muscle contractions involuntary', 'Partial seizures']",2,MODERNA,IM 980107,AL,90.0,F,Patient noted to have a change in status at 11:23PM that night. Her oxygen saturation had dropped from normal on room air to 82% and required oxygen. She was also noted to be lethargic with altered mental status and not responding verbally. She then began to mottle. Her oxygen saturation worsened to 51% on 4Liters of oxygen by the next day and she expired on 1/14/21.,Yes,01/14/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,SEN,,,,,,"['Death', 'Lethargy', 'Livedo reticularis', 'Mental status changes', 'Oxygen saturation decreased', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 980124,NJ,30.0,F,"Patient is 30 y female who was 11 weeks pregnant with a singleton gestation EDC 8/10/2021. She received the first dose of Moderna vaccine on 1/14/2021. Over the ensuing 4 days, she experienced fevers to 99.3 F, a bumpy red rash accompanied by itching at the shot site, nausea, headache, and fatigue. Tylenol 500 mg/dose was used for temperature control. She then had two days of minimal symptoms, but on 1/21 experienced sudden swelling of her left arm at the shot site with rapid expansion of the rash. The rash was itchy and the arm was painful. She had a significant headache, fatigue, and temperature to 99.3 F. These symptoms worsened over the next two days, with temperatures reaching 100 degrees F, continued headache, fatigue, and increased arm swelling. On 1/23/2021 the arm began to improve, but fevers to 99.3, fatigue and headaches continued. The rash had expanded to almost 12 cm x 6 cm. Tylenol 500 mg dosing was used for symptom control with some improvement. By 1/26/2021 the rash had mostly disappeared, the headache was gone, fevers were gone, and the fatigue remained. In all, symptoms lasted 12 days post-vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/15/2021,1.0,PVT,"Advair HFA 230/21, Prenatal vitamins",none,Asthma,,-none-,"['Condition aggravated', 'Exposure during pregnancy', 'Fatigue', 'Headache', 'Injection site pruritus', 'Injection site rash', 'Nausea', 'Pain in extremity', 'Pregnancy', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vaccination site swelling']",1,MODERNA,IM 980126,CA,41.0,F,"Date of 2nd dose received 1/17/21. HCW (Physician) pregnant at 32wks 5 days (due date 3/10/21) with preterm premature membrane rupture on 1/18/21. Was working entire weekend and overnight in hospital on call before event happened (?stress). Currently hospitalized in Labor&Delivery, received latency antibiotics, steroids and currently under expectant management.",Not Reported,,Not Reported,Yes,10.0,Not Reported,N,01/17/2021,01/18/2021,1.0,PVT,"Prenatal multivitamins, levothyroxine, cholecalciferol",,Hypothyroidism,,None,"['Exposure during pregnancy', 'Foetal non-stress test', 'Full blood count', 'Preterm premature rupture of membranes']",2,PFIZER\BIONTECH,IM 980164,ID,51.0,F,"Fever, debilitating fatigue, muscle aches, headache, chills with rigors, nausea and loss of appetite , severe left ans right upper abdominal pain",Not Reported,,Not Reported,Not Reported,,Yes,N,01/20/2021,01/20/2021,0.0,PVT,"Tramadol, syntroid, furosemide, Potassium supplement, mirapex, vitamin D, B12 injection, carafate, cimetidine",None,Restless leg syndrome. Hypothyroidism; leg swelling; obesity,Shigrix series,"Penicillin, chlorhexidine gluconate, Morphine, Codeine, hydrocodone, sulfa, Furadantin, neosporin, trazodone","['Abdominal pain upper', 'Blood alkaline phosphatase increased', 'Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",2,MODERNA,IM 980196,CA,36.0,F,"started with itching on back of neck. moved to show hives and then throat itching. Given benadryl 25 Im, pepcid 20 mg po. Initially improved, but itching started coming back. progressed to throat itching again. Given another 25 mg IM benadryl. 2-3 minutes after the benadryl, throat started feeling tight and she was coughing a little, so epi Im given and paramedics called.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/25/2021,0.0,OTH,,,,,,"['Cough', 'Pruritus', 'Throat irritation', 'Throat tightness', 'Urticaria']",1,MODERNA,IM 980243,,39.0,F,"Acute pericarditis, left pleural effusion.severe typical pericarditis and pleuritic Chest pain started 1/13 , got worse , went to Er on 1/15/2021 , was admitted to cardiology service and discharged 1/17/2021 and now on colchicine since admission.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/30/2020,01/13/2021,14.0,OTH,Levothyroxine,"Viral illness dec 15 , 2020",Hypothyroidism,,"Garbanzo beans, Nsaids","['Pericarditis', 'Pleural effusion', 'Pleuritic pain']",1,MODERNA,IM 981918,,87.0,M,"covid + on 1/21/21; admitted to hospital due to infection Narrative: Patient received the first dose of the COVID vaccine on 1/12/21. The patient tested positive for COVID 1/21/21. Admitted to Hospital on 1/23/21. Patient developed fever, cough, SOB, and diarrhea.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,OTH,,,,,,"['COVID-19', 'Cough', 'Diarrhoea', 'Dyspnoea', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,MODERNA,IM 981938,,69.0,M,"UNKNOWN/ASYTOLE Narrative: Please refer to section 6. 68y/o male with h/o severe peripheral vascular disease with previous left AKA 2/3/20, s/p bilateral bypasses in the past. Pt recently underwent right AKA on 1/12/21. Per Hospital remote data 1/10/21 pt c/o shortness of breath, CXR demonstrated right lower lobe opacity & left basilar infiltrate. Pt s/p >10 days emperic IV abx. Moderna vaccine 0.5ml IM was administered via left deltoid on 1/22/21 around 16:21. On 1/23/21@05:14 code blue was called as pt found to be unresponsive, breathless and pulseless, facial cyanosis noted, CPR started immediately.Pt found to be in asystole. ACLS guideline followed but no return of spontaneous circulation, At 05:32 pt remained pulseless and breathless and was pronounced. Autopsy currently pending.",Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/23/2021,1.0,OTH,,,,,,"['Autopsy', 'Cardiac arrest', 'Cardio-respiratory arrest', 'Chest X-ray abnormal', 'Cyanosis', 'Death', 'Lung infiltration', 'Lung opacity', 'Pulse absent', 'Respiratory arrest', 'Resuscitation', 'SARS-CoV-2 test negative', 'Unresponsive to stimuli']",1,MODERNA,IM 981945,,96.0,M,"weakness and fallsNarrative: 95 yo male w/ a PMH significant for Afib, legal blindness, Hx of CVA, cognitive impairment, GERD, HTN, pseudogout, BPH, chronic knee infection, and DJD who received his first dose of the Moderna COVID-19 vaccine on 01/08/21. The pt's COVID-19 screening questionnaire prior to receiving the vaccine was negative. The pt presented to the ED on 01/13/21 for weakness and m PCR test on ultiple recent falls (since receiving his first dose of the COVID-19 vaccine). The pt's COVID-19 01/13/20 was positive and he was admitted. He was started on treatment with remdesivir + dexamethasone on 1/14. The pt initially required supplemental oxygen via low-flow NC, however his oxygen requirements increased to 100% NRB. On 01/16/21 his MPOA elected for hospice care. The pt passed on 01/17/21. Unclear if the COVID-19 vaccine attributed to the patient's hospitalization and eventual death, or whether these events occurred from COVID-19 itself, however this case is being reported the FDA since this vaccine is under an emergency use authorization (EUA).",Yes,01/17/2021,Not Reported,Yes,,Not Reported,N,01/08/2021,01/13/2021,5.0,OTH,,,,,,"['Asthenia', 'COVID-19', 'Death', 'Fall', 'SARS-CoV-2 test positive']",1,MODERNA,IM 983720,,76.0,M,Death Narrative: Patient had Parkinson's and advanced Dementia. He was on a palliative care unit and a DNR.,Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/20/2021,21.0,OTH,,,,,,['Death'],1,MODERNA,IM 983721,,72.0,M,Death Narrative: Patient with Severe Dementia and on Hospice for end of life care.,Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/23/2021,10.0,OTH,,,,,,['Death'],1,MODERNA,IM 980324,PR,71.0,M,"mild headache; mild rash; mild stomach upset; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration (left arm) on 15Jan2021 13:30 at single dose for Covid-19 immunization. The patient's medical history included asthma and allergic rhinitis; no known allergies. Concomitant medications included guaifenesin (ROBITUSSIN), levosalbutamol (LEVALBUTEROL), azelastine hcl, and unspecified vitamin (reported as ""vit""). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 (15:45), the patient experienced mild adverse events reported as headache, mild rash within approximately 8 hours after vaccination, mild stomach upset in the morning after vaccination. The patient was treated with 10 mls Benadryl and chamomile tea on 16Jan2021 ""mor"". The patient has been tested for COVID-19 post vaccination (unspecified date) with unknown result. The patient had been tested for Covid with Nasal Swab on 01Jan2021 (Ag) and on 07Jan2021 (PCR) both with negative result. The outcome of events was recovered on an unspecified date in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,PVT,ROBITUSSIN [GUAIFENESIN]; LEVALBUTEROL [LEVOSALBUTAMOL]; AZELASTINE HCL,,Medical History/Concurrent Conditions: Allergic rhinitis; Asthma,,,"['Abdominal discomfort', 'Headache', 'Rash', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 980590,KY,44.0,F,"her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; Tiredness; scratchy throat which got worse with time; tenderness around the injection site; it felt really bad almost like a flu; it felt really bad almost like a flu; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: 30Apr2021, NDC number: 59267100001), intramuscular in the left deltoid, on 08Jan2021, at 0.3 mL, single, for COVID-19 immunization. There were no medical history and concomitant medications. The patient reported she had side effects after receiving the first dose (Jan2021). She had a scratchy throat which got worse with time. She had a general muscle ache, tenderness around the injection site. The muscle ache increased with chills and low grade fever. She said it felt really bad almost like a flu. She reported her eye is still swollen with chills and low grade fever. She further clarified that she was given the vaccine on 08Jan2021, Friday afternoon. On 09Jan2021, Saturday, she had muscle aches, tiredness, and by Saturday night she had a scratchy throat. On 10Jan2021, Sunday, she experienced tiredness and muscle cramps. She worked half day on 11Jan2021, Monday, and by the afternoon she had chills and low grade fever. On 12Jan2021, Tuesday morning, she woke up and her eyes were swollen. She noticed the swelling has decreased a little bit. She didn't have any symptoms such as difficulty breathing. The reporter asked what have caused these side effects and why did her immune response react this way after receiving the vaccine. She mentioned that her second dose is set up for the end of January and asked if she will be able to get the second dose since she had a reaction and she was wondering if had an illness when she got the vaccine could that have caused her to have a hyper response in her immune system to the vaccine. The outcome of the events scratchy throat which got worse with time, general muscle ache, tiredness, muscle cramps, eye swelling and low grade fever was recovering; chills was not recovered; and the outcome of the remaining events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Eye swelling', 'Fatigue', 'Injection site pain', 'Malaise', 'Muscle spasms', 'Pyrexia', 'Throat irritation']",1,PFIZER\BIONTECH,OT 980591,MA,46.0,F,"She received the 1st dose on 28Dec2020. She taShe received the 1st dose on 28Dec2020. She tested positive to COVID-19 on 06Jan2021ested positive to COVID-19 on 06Jan2020.; She received the 1st dose on 28Dec2020. She tested positive to COVID-19 on 06Jan2021; This is a spontaneous report from a contactable nurse. A 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: )Mar2021 , via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. There were no relevant medical history and concomitant medications. The patient received the 1st dose on 28Dec2020. She tested positive to COVID-19 on 06Jan2021. She was still currently in isolation and symptomatic. Her second dose was scheduled on 18Jan2020. The outcome of the event was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive to COVID-19 based on the known safety profile. However the short duration of 9 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/06/2021,9.0,SEN,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 980592,NC,79.0,M,"twisted his back a little bit/strained his back; he is having some muscle pain; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 13Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient) reported that a 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he is in good physical health. The patient stated that he is 79 years old, and received his first dose of the COVID vaccine 48 hours ago, on Monday at noon (11Jan2021). The patient strained his back last night (12Jan2021), and he is having some muscle pain, and he would like to know if it is okay to take Ibuprofen, following having received the vaccine. The patient clearly stated that he has had no side effects and he is fine from the vaccine. He also added that it was while he was in the shower last night, he twisted his back a little bit, and that happens to him now and then and that was normally when this happens to him, it takes a few days to get better. But patient stated that this event is totally unrelated to the COVID vaccine. The patient normally just takes a Motrin, and it clears the pain up, it relieves it. But he was just wondering if it is contraindicated to take Motrin after having had the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The events back strain and muscle pain were intercurrent conditions and unrelated to BNT162B2 vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/12/2021,1.0,UNK,,,,,,"['Muscle strain', 'Myalgia', 'No adverse event']",1,PFIZER\BIONTECH, 980593,MN,,U,"she has pulled some of the vials that were used out of the sharps container and peeled off the label to find that the dots and lines disappeared. We didn't inject the vial into the patient; This case has been considered as invalid due to no adverse effect, only product complaint. This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiry date: unknown, NDC number: 59267- 1000-1 ) via an unspecified route of administration, on an unspecified date, at 30mg/0.3mL, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that she has multiple vials of the COVID-19 vaccine that have either dots or fixed lines on the vials, presumably what could be a potential crack in the vial. The vials were all smooth on the outside. There are no particles and the vaccine looks normal, even after its been reconstituted. She pulled some of the vials that were used out of the sharps container and peeled off the label to find that the dots and lines disappeared. She felt that they may be a result of air trapped between the label and the vial but she states that she is not sure and would like to know if she can still use the product or should discard them. In follow-up the pharmacist reported seeing something strange in the vial after reconstituting it with the diluent. She noticed what looks like a core as she injected the syringe and on further injection, she noticed that the piece was reflecting and picking up light and this piece was not moving in the solution. And she added that there are 2 vials with this appearance, and they have the same LOT#. Pharmacist stated, they didn't inject the vial into the patient. Pharmacist stated, ""It is not floating, it is a fixed spot on the vial where, when I look from one angle it looks like there could potentially be a core. So, it shows almost grey. When I move the vial, I can see the reflected light within the particle slightly and then if I move the vial further over where there is no fluid covering the spot, the spot is not noticeable. One vial is one spot, the other vial is a spot and what looks almost to be scraped on the inside. It is grey in color until I move the vial as such to where there is no fluid covering it, then it disappears. And when I move the vial further when there is fluid covering it, it will reflect light, so it's not really a true like particles, it's hard to describe. It is very, very small in 1 vial, may be the size like of a, I don't know like similar to like a 21 gauge needle. And then on the other vial it is one spot that's larger than that almost like the end of paper clip and then the part that almost appears to be like 'dry are faded' (voice distortion) and those are very, very faint lines. This happened after dilution of the vial with Sodium Chloride. I did not notice this prior to, I inspected the vial prior to dilution and I did not notice that either. At this point I completed the dilution around 8:55 for one of the vials and 9 o' clock for the other so. It has been at as far as I am aware I have access to our continual monitor but we do keep a paper log of the refrigerator temp every day and it has been under refrigeration. It was removed from the ultra-low freezer at 8 o' clock on 11th, on Monday."" Follow-up (13Jan2021): New information received from a contactable pharmacist includes: clinical course and confirmed they didn't inject the vial into the patient. Sodium Chloride added as suspect drug.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,Sodium Chloride,,,,,['No adverse event'],UNK,PFIZER\BIONTECH, 980611,TX,,M,"Tested positive on 11Jan2021; Tested positive on 11Jan2021; This is a spontaneous report from a contactable consumer (daughter reporter for her father). An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no and expiry date not reported), via an unspecified route of administration on 28Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Daughter calling on behalf of father, aged 88, who lives in assisted living received his first dose on 28Dec2020. However, patient tested positive on 11Jan2021, and was moved to a covid facility. He is scheduled to receive his second dose on 18Jan2021. The daughter asked if her father could get the second covid vaccine after being sick. She also asked what if his father can't go back to his regular nursing home in time? Does he have to restart the vaccination schedule? The outcome of the events was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/11/2021,14.0,UNK,,,,,,"['Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 980613,MA,,U,"Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program Pfizer First Connect. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the first of 20 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and tested positive for the virus (COVID-19) on an unspecified date. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection. Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021042231 same reporter, same drug/event, different patient;US-PFIZER INC-2021042229 same reporter, same drug/event, different patient;US-PFIZER INC-2021042217 same reporter, same drug/event, different patient;US-PFIZER INC-2021042222 same reporter, same drug/event, different patient;US-PFIZER INC-2021042224 same reporter, same drug/event, different patient;US-PFIZER INC-2021042225 same reporter, same drug/event, different patient;US-PFIZER INC-2021042230 same reporter, same drug/event, different patient;US-PFIZER INC-2021042220 same reporter, same drug/event, different patient;US-PFIZER INC-2021042218 same reporter, same drug/event, different patient;US-PFIZER INC-2021042234 same reporter, same drug/event, different patient;US-PFIZER INC-2021042233 same reporter, same drug/event, different patient;US-PFIZER INC-2021042221 same reporter, same drug/event, different patient;US-PFIZER INC-2021042219 same reporter, same drug/event, different patient;US-PFIZER INC-2021042223 same reporter, same drug/event, different patient;US-PFIZER INC-2021042228 same reporter, same drug/event, different patient;US-PFIZER INC-2021042226 same reporter, same drug/event, different patient;US-PFIZER INC-2021042216 same reporter, same drug/event, different patient;US-PFIZER INC-2021042232 same reporter, same drug/event, different patient;US-PFIZER INC-2021042227 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 980627,IL,45.0,M,"I developed COVID positive test; I developed COVID positive test; Had mild to moderate illness; This is a spontaneous report from a contactable physician reporting for himself. A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular, on 23Dec2020, single dose for COVID-19 immunization. Relevant medical history and concomitant medication was reported as none. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient was not diagnosed with COVID before vaccination. On 30Dec2020 at 4:15 PM, after the first vaccine dose, within a week the patient developed COVID positive test. The patient had mild to moderate illness on an unspecified date. Therapeutic measure taken in response to the events included administration of Tylenol. The patient underwent covid test via nasal swab on 31Dec2020 and showed positive result. Outcome of the events was not recovered. Information for Lot/Batch number has been requested; Sender's Comments: The PFIZER-BIONTECH COVID-19 VACCINE provides protection after 7 days from the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Illness', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 980660,CA,38.0,F,"nasal swab covid test result positive; nasal swab covid test result positive; This is a spontaneous report from a contactable Other HCP (for herself) reported that a 38-year-old female (not pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EJ1685 and Expiration Date unknown) intramuscularly on 21Dec2020 01:45 PM at single dose (Left arm) for COVID-19 immunisation. The patient's medical history was known allergies: Penicillin, clindamycin, doxycycline. The concomitant medications was not reported. No other vaccine in four weeks. Patient experienced nasal swab covid test type post vaccination on 01Jan2021 was positive. The outcome was unknown with no treatment.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported nasal swab covid test positive based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,01/01/2021,11.0,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH,OT 980703,MO,44.0,F,"fever; hip pain; 'pretty intense joint pain, felt like it was on fire; She feels ''like death today""/she did not feel good; Chills; This is a spontaneous report from a contactable nurse. A 44-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3248) intramuscular on 14Jan2021 single dose for COVID-19 immunisation. Vaccine location was deltoid left. No other vaccine was received in four weeks. The patient medical history was not reported. Historical vaccine included first dose of BNT162B2 (Lot: EL1284) received on 28Dec2020 around 7pm, intramuscular injection right deltoid. There were no concomitant medications. The patient experienced fever (she woke up with a fever of 101.3 at 6am), pretty intense 'joint pain, felt like it was on fire' on 14Jan2021; with the first dose of the covid vaccine she had really bad hip pain about 24 hours after (as reported) and it lasted about 12 hours but she could still walk and move, it was just annoying. The patient was ''like death today""/ she did not feel good' on 14Jan2021, chills on 14Jan2021. Her temperature has improved and it is around 99. The outcome of fever and chills was recovering, of 'pretty intense joint pain, felt like it was on fire' was recovered on 15Jan2021, of she feels 'like death today'/ she did not feel good and hip pain was unknown.; Sender's Comments: A possible contributory effect of suspect BNT12B2 on reported fever cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,PVT,,,,,,"['Arthralgia', 'Chills', 'Feeling abnormal', 'Pyrexia']",UNK,PFIZER\BIONTECH,OT 980706,OH,,U,"Covid + since receiving the first dose; Covid + since receiving the first dose; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included near end of life (patient was transitioned to hospice). The patient's concomitant medications were not reported. Per second (2nd) vaccination clinic on 12Jan2021, it was reported the one resident was transitioned to hospice (and is near end of life) and also reported was COVID positive (+) since receiving the first dose on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event COVID positive (+) based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Terminal state (transitioned to hospice),,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 980708,OH,,U,"contracted covid after receiving the 1st vaccine dose; contracted covid after receiving the 1st vaccine dose; This is a spontaneous report from contactable nurse. This Nurse reported same events for six patients. This report is for 1st of six reports. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 22Dec2020 at a single dose in the nursing home for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient contracted COVID after receiving the 1st vaccine dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 22Dec2020, and contracted COVID on an unspecified date. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection. Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021035080 same reporter/drug/event, different patient;US-PFIZER INC-2021035079 same reporter/drug/event, different patient;US-PFIZER INC-2021035081 same reporter/drug/event, different patient;US-PFIZER INC-2021035082 same reporter/drug/event, different patient;US-PFIZER INC-2021035083 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,SEN,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 980709,OH,,U,"contracted covid after receiving the 1st vaccine dose; contracted covid after receiving the 1st vaccine dose; This is a spontaneous report from a contactable nurse. This nurse reported same events for six patients. This is the second of six reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 22Dec2020 at a single dose in the nursing home for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient contracted covid after receiving the 1st vaccine dose. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The PFIZER-BIONTECH COVID-19 VACCINE provides protection after 7 days from the second dose.,Linked Report(s) : US-PFIZER INC-2021035078 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 980710,OH,,U,"contracted covid after receiving the 1st vaccine dose; contracted covid after receiving the 1st vaccine dose; This is spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is 4th of 6 reports. An unknown age and gender patient received first dose of BNT162B2 (Pfizer BioNTech Covid 19 vaccine) on 22Dec2020 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. It was reported that patient contracted COVID after receiving the 1st vaccine dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 22Dec2020, and contracted COVID on an unspecified date. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection. Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021035078 same reporter/product/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 980711,OH,,U,"contracted covid after receiving the 1st dose and were still symptomatic; contracted covid after receiving the 1st dose and were still symptomatic; This is spontaneous report from a contactable nurse via Pfizer sales representative. This nurse reported similar events for 6 patients. This is the sixth of six reports. A patient of unknown age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 22Dec2020 at single dose in the nursing home for COVID-19 immunization. Medical history and concomitant drugs were not reported. On an unspecified date, patient contracted covid after receiving the 1st dose and were still symptomatic and was unable to receive their 2nd dose on 12Jan2021. Outcome of events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021035078 same reporter/product/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,,,SEN,,,,,,"['COVID-19', 'Inappropriate schedule of product administration', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 980712,OH,,U,"Recent COVID + diagnosis/Covid exposure; Recent COVID + diagnosis/Covid exposure; This is a spontaneous report from two contactable nurses via a Pfizer sales representative. This author reported similar events for 4 patients. This is 1st of 4 reports. A patient of unspecified age and gender receive 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had been vaccinated with a 1st dose and had to defer to 02Feb2021 due to recent COVID + diagnosis/COVID exposure. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021035087 the same reporter, product and adverse events in different patients;US-PFIZER INC-2021035086 the same reporter, product and adverse events in different patients;US-PFIZER INC-2021035085 the same reporter, product and adverse events in different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,SEN,,,,,,"['COVID-19', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 980713,OH,,U,"COVID + diagnosis/Covid exposure; COVID + diagnosis/Covid exposure; This is a spontaneous report from contactable nurses. This nurse reported same events for 4 patients. This is 2nd of 4 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that 4 employees that had been vaccinated with a 1st dose had to defer to 02Feb2021 due to recent COVID + diagnosis/Covid exposure. Lab test included positive covid test. The outcome of events was unknown. Information on the lot/batch number has been requested; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021035084 the same reporter, product and adverse events in different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,UNK,,,,,,"['COVID-19', 'Exposure to SARS-CoV-2', 'Inappropriate schedule of product administration', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 980714,OH,,U,"recent COVID + diagnosis/Covid exposure; recent COVID + diagnosis/Covid exposure; This is a spontaneous report from contactable nurses. This nurse reported similar events for 4 patients. This is the third of four reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 22Dec2020 for COVID-19 immunisation. Medical history and concomitant medication were not reported. Reporter stated 4 employees that had been vaccinated with a 1st dose had to defer to 02Feb2021 due to recent COVID + diagnosis/COVID exposure. Event took place after use of product. Covid test was positive. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021035084 the same reporter, product and adverse events in different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,UNK,,,,,,"['COVID-19', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 980715,OH,,U,"Recent COVID + diagnosis/Covid exposure; Recent COVID + diagnosis/Covid exposure; This is a spontaneous report from contactable nurses. This nurse reported same events for 4 patients. This is 4th of 4 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that 4 employees that had been vaccinated with a 1st dose had to defer to 02Feb2021 due to recent COVID + diagnosis/Covid exposure. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021035084 same reporter, product and adverse events in different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,UNK,,,,,,"['COVID-19', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 980761,,,F,"Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a non-contactable consumer. This (age: 56, unit: unknown) female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 30Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant drugs were not reported. Patient was tested positive for Covid today, 14Jan2021. She was scheduled to get her next dose 20Jan2021. She had no symptoms. She received a negative Covid test result yesterday (16Jan2021). She would be quarantining for 2 weeks. Outcome of events was unknown. No follow-up attempts are possible; Information about Lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/14/2021,15.0,UNK,,,,,,"['Inappropriate schedule of product administration', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 980794,,,M,"her husband contracted SARS-Cov-2 10 days after vaccination; her husband contracted SARS-Cov-2 10 days after vaccination; This is a spontaneous report from a contactable Physician (patient's wife). This physician reported similar events for two patients. This is the second of two reports. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient (reporter's husband) contracted sars-cov-2 10 days after vaccination in Jan2021. The physician was looking for direction on receiving the second dose. Outcome of the event was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.,Linked Report(s) : US-PFIZER INC-2021025409 same reporter/drug/events, different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 980799,,,M,"Fever; Chills; Myalgia; Fatigue; This is a spontaneous report from a non-contactable physician (patient). A 32-year-old male patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK9231), via an unspecified route of administration on 12Jan2021 09:30 in left arm at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 on 22Dec2020 for COVID-19 immunization. There were no medical history or concomitant medications. No known allergies. There was no other vaccine in four weeks. There was no other medication in two weeks. On 13Jan2021 01:00, the patient experienced fever, chills, myalgia, fatigue. No treatment was received for these adverse events. No COVID prior vaccination. No COVID tested post vaccination. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. The outcome of all the events was recovering. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Fatigue', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH, 980809,FL,36.0,F,"positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable Nurse reporting for herself. A 36-year-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration in the left arm, on 22Dec2020 16:30 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Dec2020 the patient resulted positive to Covid-19 test (nasal swab), but the patient did not show symptoms. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,PVT,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 980811,DE,56.0,F,"Severe low back and hip pain; Severe low back and hip pain; malaise; woke up soaking wet in the middle of the night with chills; Extremely tired; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscularly on 07Jan2021 10:30 at a single dose in left arm for COVID-19 immunization. The patient is not pregnant. Medical history included hypothyroidism, hypertension, known allergies: penicillin. The patient previously took first dose of bnt162b2 (lot number: EK5730) via intramuscular on 18Dec2020 13:30 at a single dose in left arm for COVID-19 immunization. There was no other vaccine administrated in four weeks. Concomitant medication included losartan, bupropion hydrochloride (WELLBUTRIN), levothyroxine, colecalciferol (VITAMIN D 3), estradiol (ESTROGEN), and progesterone. On 09Jan2021 15:45, the patient experienced severe low back and hip pain along with general malaise, woke up soaking wet in the middle of the night with chills, and extremely tired. No fever. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No treatment received for adverse event. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of events was recovered on an unspecified date in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,PVT,LOSARTAN; WELLBUTRIN; LEVOTHYROXINE; VITAMIN D 3; ESTROGEN; PROGESTERONE,,Medical History/Concurrent Conditions: Hypertension; Hypothyroidism; Penicillin allergy,,,"['Arthralgia', 'Back pain', 'Chills', 'Fatigue', 'Hyperhidrosis', 'Malaise', 'Sleep disorder']",2,PFIZER\BIONTECH,OT 980816,CA,31.0,F,"tested positive for COVID virus; tested positive for COVID virus; This is a spontaneous report from a Pfizer-sponsored program. A contactable other HCP (health care worker, patient) reported that a 31-year-old female patient received 1st dose of BNT162B2 (COVID 19 Vaccine, Batch/lot number: EL0140) on 23Dec2020 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. She received the first dose of the vaccine 23Dec2020. Then, on 05Jan2021, she tested positive for the COVID virus. She was supposed to get the second dose of the Vaccine on 13Jan2021. She was put on quarantine. She is wondering if she can she still get the vaccine or does she need to wait. Outcome of the event was unknown. No further information is expected. Information about lot/batch number has been obtained.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/05/2021,13.0,PVT,,,,,,"['Inappropriate schedule of product administration', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 980857,MA,,U,"tested positive for covid after 1st dose received on 03Jan2021; tested positive for covid after 1st dose received on 03Jan2021; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported similar events for 15 patients. This is 8th of 15 reports. A patient of an unspecified gender and age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. As per caller 15 residents tested positive for covid after 1st dose received on 03Jan2021. Would like to know if and when they should receive the second dose i.e. wait 10-14 days without symptoms.The second dose was scheduled for 24Jan2021. The outcome of events was unknown. Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported ""tested positive for covid after 1st dose"".,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 980858,MA,,U,"had tested positive for the virus (COVID) after the first dose of the vaccine; had tested positive for the virus (COVID) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported same event for 20 patients (15 residents and 5 staff members). This report is for 11th of 15 residents. A patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), at single dose for COVID-19 immunisation on 03Jan2021. The patient's medical history and concomitant medications were not reported. The patient had tested positive for the virus (COVID) after the first dose of the vaccine in Jan2021. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and tested positive for the virus (COVID-19) in Jan2021. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection. Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 980859,MA,,U,"Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the 14th of 20 reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. The second dose is scheduled for 24Jan2021. The outcome of the event was unknown. Information on the lot/batch number has been requested. Sender's Comments: The PFIZER-BIONTECH COVID-19 VACCINE provides protection after 7 days from the second dose,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 980860,MA,,U,"Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the 15th of 20 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The PFIZER-BIONTECH COVID-19 VACCINE provides protection after 7 days from the second dose.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 980868,TX,24.0,F,"allergies; positive for COVID 19; positive for COVID 19; This is a spontaneous report from a contactable consumer(patient) from Pfizer-sponsored program Pfizer First Connect. The 24-year-old female consumer received first dose of bnt162b2 (BNT162B2, lot number: 1686), unknown on 05Jan2021 at SINGLE DOSE by injection once to left arm for covid-19 immunisation. Medical history and concomitant medications were none. The patient got the first dose of the COVID 19 vaccine and got positive for COVID 19 on 13Jan2021, and is asking if she will have to take the second dose as per her scheduled date. States she thought this was just allergies, since she takes Zyrtec and it clear up everything. No further details provided. The outcome of the event drug allergy was unknown and was not recovered for the rest events. No follow-up attempts possible. No further information expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/13/2021,8.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 980879,SC,45.0,F,"COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK570), via an unspecified route of administration in the left upper arm on 21Dec2020 at a single dose for COVID-19 immunization. Medical history was none and there were no concomitant medications. The patient stated that she felt yucky afterwards on 23Dec2020, experienced shortness of breath on exertion and coughing on 26Dec2020; chills, dizziness, headache, muscle pain, body aches, fever on 28Dec2020; loss of taste, loss of smell and COVID-19 pneumonia on 07Jan2021. All the events were reported as being medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 29Dec2020. Therapeutic measures were taken as a result of COVID-19 pneumonia and included: started on bronchodilator, cough elixir, steroids and azithromycin (ZITHROMAX). The outcome of muscle pain, body aches and COVID-19 pneumonia was recovering and of loss of taste and loss of smell was not recovered. The causality of the suspect vaccine to the events was reported as related.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,01/07/2021,17.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Ageusia', 'Anosmia', 'COVID-19 pneumonia', 'Chills', 'Cough', 'Dizziness', 'Dyspnoea', 'Feeling abnormal', 'Headache', 'Myalgia', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 980885,TX,88.0,M,"Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient's daughter) via the Pfizer sponsored program Pfizer First Connect. An 88-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 28Dec2020 to 28Dec2020 at SINGLE DOSE for covid-19 immunisation. Medical history included was reported as none. There were no concomitant medications. The reporter stated that the patient had tested positive for covid on 11Jan2021. Outcome of the event was unknown. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/11/2021,14.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 980904,MD,52.0,F,"Lymphadenopathy; mild fatigue; Myalgia; This is a spontaneous report from a contactable physician (patient). A 52-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), intramuscular in the left arm on 12Jan2021 at 16:30 as a single dose to prevent COVID. The patient's concomitant medications were not reported and it was reported that she had no relevant medical history. The patient previously received the first dose of BNT162B2 on 22Dec2020 at 14:00. The patient did not receive any other vaccine/s on the same date as BNT162B2, did not have prior vaccination within four weeks of receiving BNT162B2, and did not experience any adverse event following prior vaccinations. The patient experienced mild fatigue and myalgia on 13Jan2021, and lymphadenopathy on 14Jan2021. Seriousness for the events was reported as serious (medically significant). The patient received her second dose of the Pfizer Covid Vaccine on 12Jan2021 at 16:30. She experienced mild fatigue and myalgia after 24 hours which has improved. She clarified that the mild fatigue and myalgia resolved by this morning. She felt lymphadenopathy in her lower neck and supraclavicular area. Stated it was almost fullness she can feel, there was no redness and it was not tender. She was hoping this was related to the vaccine that she got in her left upper arm. She went to the CDC and Pfizer website and saw that lymphadenopathy was mentioned but it was a small percentage. The patient declined any treatment. The events did not require a visit to the Emergency Room of Physician's office. Outcome of the events fatigue and myalgia was recovered on 15Jan2021, while for the event lymphadenopathy was not recovered. The reporter's causality assessment between the events and BNT162B2 for the events fatigue and myalgia was related, while for the event lymphadenopathy was unknown. Information about the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events fatigue, myalgia and lymphadenopathy are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,PVT,,,,,,"['Fatigue', 'Lymphadenopathy', 'Myalgia']",2,PFIZER\BIONTECH,OT 980908,,,F,"Covid positive; Covid positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable consumer (patient). This reporter reported similar events for 2 patients (reporter and reporter's husband). This is 1st of 2 reports reported for the reporter. A female patient of an unspecified age received first dose of BNT162B2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient and her husband both had vaccine on Friday and they discovered that they both were Covid positive on Monday. Patient did not have symptoms but her husband did, the question was whether they should still get the second shot. Events outcome was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021049698 Same reporter, same drug, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 980939,,,U,"Received the Vaccine (Unspecified Vaccine),contracted Covid after that; Received the Vaccine (Unspecified Vaccine),contracted Covid after that; This is a spontaneous report from a non-contactable healthcare professional (patient). A patient of unspecified age and gender received first single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine. Patient was a healthcare provider and then contracted Covid after that. Patient asked if she should still go ahead and still take the dose of the vaccine. The outcome of the events was unknown. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained. No further information is expected; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 981061,TN,87.0,F,Patient died 3 days post Moderna vaccine.,Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/25/2021,3.0,SEN,Unsure,None,Unsure,,Unsure,['Death'],1,MODERNA,SYR 981099,NY,35.0,M,"Patient reportedly had shortness of breath, hives, diarrhea, nausea, vomiting approximately 4 hours after receiving vaccine. Symptoms resolved with Benadryl.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,,,,,,"['Diarrhoea', 'Dyspnoea', 'Nausea', 'Urticaria', 'Vomiting']",UNK,MODERNA, 981141,GA,34.0,F,High fever. Aches chills. Sob. 4 days. Passed on 1/27/2021,Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/22/2021,01/23/2021,1.0,WRK,Loratadine 10mg. Spiralactine 100 mg. Sertraline half dose.,Anemia,,,PCN. Clindamycin,"['Chills', 'Dyspnoea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 981164,CA,34.0,F,"I was 22 months pregnant I chose to get the vaccine because I work with Covid patients at hospital as a PA. 8 days after the vaccine, I got a needle stick at work. As part of the work up for this, they checked my ALT and it was markedly elevated (previously well within normal range).",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/22/2021,8.0,UNK,None,None,None,,None,"['Alanine aminotransferase increased', 'Exposure during pregnancy', 'Pregnancy']",UNK,PFIZER\BIONTECH, 981170,PA,54.0,F,"Moderna COVID-19 Vaccine EUA given approximately 7:50 am on 1/25/2021 I left deltoid. By 4 pm, arm sore, noticeable fatigue and headache. Approximately 7 pm, chills started and headache much worse. Temperature was 100.7. Took a Tylenol. Around 8:30 pm became extremely nauseous and began vomiting. Vomited several times, and became dizzy and near syncopal and confused. Eyesight blurred. Husband called 911. Taken to Hospital and was in hospital until 1/27/21.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/25/2021,01/25/2021,0.0,PVT,None,None,Asthma,,Compazine,"['Blood test', 'Body temperature increased', 'Chills', 'Confusional state', 'Dizziness', 'Electrocardiogram', 'Fatigue', 'Headache', 'Nausea', 'Pain in extremity', 'Presyncope', 'Vision blurred', 'Vomiting']",UNK,MODERNA,IM 981180,IA,19.0,F,"Vaccine was administered into the subacromial space/joint of right shoulder instead of deltoid muscle. Patient presents on 1/27/2021 after onset of pain, decreased ROM ongoing since administration. I was able to visualize ecchymotic area where vaccine was administered and patient has photo evidence. The physician responsible for the vaccine administration needs to be retrained on where to give deltoid muscle IM injections and to avoid the extremities where recent surgeries occurred (patient had right shoulder labrum repair in October 2020)",Not Reported,,Not Reported,Not Reported,,Yes,N,01/18/2021,01/18/2021,0.0,PUB,None,None,None,,None,"['Injected limb mobility decreased', 'Injection site haemorrhage', 'Laboratory test', 'Pain in extremity', 'Product administered at inappropriate site']",UNK,MODERNA, 981225,MD,59.0,F,"Patient with inoperable pancreatic cancer received second Pfizer vaccine approximately 12:30 pm on 1/27/21. At approximataely 16:30, patient complained of abdominal pain and was given Levsin 0.125mg and morphine 5mg orally. At approximately 19:30 patient was found on the floor covered in a large amount of emesis, unresponsive without a pulse.",Yes,01/27/2021,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,SEN,Acetaminophen Suppository Insert 650 mg rectally every 6 hours as needed for pain 1-3 Bisacodyl Suppository 10 MG Insert 1 suppository rectally every 24 hours as needed for constipation COVID-19 mRNA Vaccine (Pfizer) Suspension 30 MCG\/0.3M,,"C25.9 MALIGNANT NEOPLASM OF PANCREAS, UNSPECIFIED B19.20 UNSPECIFIED VIRAL HEPATITIS C WITHOUT HEPATIC COMA S82.002D UNSPECIFIED FRACTURE OF LEFT PATELLA, SUBSEQUENT ENCOUNTER FOR CLOSED FRACTURE WITH ROUTINE HEALING J44.9 CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED F03.90 UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE D64.9 ANEMIA, UNSPECIFIED Z91.81 HISTORY OF FALLING E46 UNSPECIFIED PROTEIN-CALORIE MALNUTRITION G31.84 MILD COGNITIVE IMPAIRMENT, SO STATED I10 ESSENTIAL (PRIMARY) HYPERTENSION G40.89 OTHER SEIZURES F32.9 MAJOR DEPRESSIVE DISORDER, SINGLE EPISODE, UNSPECIFIED F41.9 ANXIETY DISORDER, UNSPECIFIED M62.81 MUSCLE WEAKNESS (GENERALIZED) R26.89 OTHER ABNORMALITIES OF GAIT AND MOBILITY R41.841 COGNITIVE COMMUNICATION DEFICIT Z11",,"Imipenem, Penicillins, Peanut","['Abdominal pain', 'Death', 'Pulse absent', 'Unresponsive to stimuli', 'Vomiting']",2,PFIZER\BIONTECH,IM 981249,NH,51.0,F,I had covid nov 23 2020. On jan 25 I had a stroke Couldn't talk. Couldn't move my left arm or leg. I received TPA.,Not Reported,,Yes,Yes,2.0,Not Reported,Y,12/29/2020,01/25/2021,27.0,WRK,Lisinopril 10 mg daily. Zoloft 75 mg daily. Atenolol 25mg,Covid nov 23,"HTN, anxiety/ depression",,None,"['Aphasia', 'Cerebrovascular accident', 'Computerised tomogram', 'Full blood count', 'Magnetic resonance imaging', 'Metabolic function test', 'Mobility decreased']",1,MODERNA,IM 981303,,,M,"pneumonia; Initial information was received on 21-Jan-2021 regarding an unsolicited valid serious case from a consumer/non-health care professional. This case involves an 87 years old male patient who had a fatal pneumonia, while he received INFLUENZA VACCINE. It is unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment(s), past vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination On an unknown date, the patient developed a serious pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. The patient was full of hair, most of his teeth and healthy to his last year with no flu shot ever until the last year. It is unknown if the patient experienced any additional symptoms/events There were no laboratory data/results available. It was not reported if the patient received a corrective treatment before death. At the time of report, the outcome of event was fatal It is unknown if an autopsy was done. The cause of death was Pneumonia. Information on batch number was requested for this case; Sender's Comments: This poorly documented case, involves an 87 years old male patient who had a fatal pneumonia following the administration of INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Additional information regarding patient's medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed; Reported Cause(s) of Death: pneumonia",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Death', 'Pneumonia']",UNK,UNKNOWN MANUFACTURER,OT 981315,VA,41.0,M,"After vaccine was given, patient was cleaned up after having a bowel movement and shortly after, patient became tachypneic with nasal flaring and verbalized the words ""can't breathe."" Dr. was notified and came to the bedside to assess. Patient had audible upper airway wheezes and orders obtained for Epi, benadryl and solumedrol. RT also came to bedside to assist. 1mg Epi x2 given 25mg Benadryl given 125mg Solumedrol given Anesthesia was called for intubation due to continuing low sats. -7.5 ETT noted at 22@lip -OG@60 Both were cleared via CXR. -0307: patient sedated and resting comfortably.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,PVT,"Hospital meds the day of the event: furosemide, KCL, albumin, ceftriaxone, dexmedetomodine, lactulose, midodrine, octreotide, pantoprazole, and rifaximin",alcoholic cirrhosis and esophageal varices,of alcoholic cirrhosis and esophageal varices,,NKDA,"['Chest X-ray normal', 'Death', 'Dyspnoea', 'Endotracheal intubation', 'Hepatic cirrhosis', 'Nasal flaring', 'Oxygen saturation decreased', 'Tachypnoea', 'Wheezing']",1,GLAXOSMITHKLINE BIOLOGICALS,IM 981332,SC,92.0,F,"Resident became chilled, unable to get warm, shivering, unable to get up, oxygen saturation dropped to 50% with heart rate of 133. Tachypnea",Not Reported,,Not Reported,Yes,,Not Reported,N,01/27/2021,01/27/2021,0.0,OTH,"Fibercon, Imodium AD, Align, Proair inhaler, Potassium, hydrocortisone, levothyroxine",WEAKNESS,"DILATED CARDIOMYOPATHY, UNSPECIFIED ADRENOCORTICAL INSUFFICIENCY, HYPOKALEMIA, IRRITABLE BOWEL SYNDROME WITH DIARRHEA, HYPOTHYROIDISM, HISTORY OF COVID-19",,No known allergies,"['Chills', 'Feeling cold', 'Mobility decreased', 'Oxygen saturation decreased', 'Pulmonary oedema', 'Tachypnoea']",2,MODERNA,IM 981338,FL,39.0,F,"head ache, sore arm, dizziness, nausea, numbness down right hand and leg, fever",Not Reported,,Not Reported,Yes,,Not Reported,U,01/25/2021,01/25/2021,0.0,PVT,,,,,,"['Dizziness', 'Headache', 'Hypoaesthesia', 'Nausea', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 981406,TN,71.0,F,"Stroke, death",Yes,01/18/2021,Not Reported,Yes,,Not Reported,N,01/15/2021,01/18/2021,3.0,SEN,"multiple, unknown",,"COPD, smoker",,unknown,"['Cerebrovascular accident', 'Death']",1,MODERNA,IM 981407,MO,48.0,F,Expired in sleep on 1/24/21,Yes,01/24/2021,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/24/2021,18.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 981535,WI,89.0,F,"The next morning after receiving the vaccine I noticed that my mother she talking to me, as her primary giver she knows me and comfortable to me. She tells me the same story over the over with isn't abnormal. It was every 3-4 words she was jumbling her words. I didn't think anything of it at first. I just let it go. Early Wednesday morning 2:48am, I heard her in her bedroom. I went to check on her, I found at her dresser trying to put her watch on. She didn't know who was I or didn't know where she was. It took me about 40 minutes to calm her down. Now it was every 2 words that she was jumbling up. I finally got her back to bed. I went to send a message to her doctor. In the morning someone from the doctor's office called back I explained what was going on and they said get her to an ER. I took her to the hospital 01/27/2021. She was admitted to hospital for overnight observation. Still not been discharged. Patient was still confused when I had to left last night, did not understand where she was at or why she had to stay there. My mother was very angry when she woke up early Wednesday is not my mom she is very lovely. One year or two years she did have a TA or mini stroke.",Not Reported,,Not Reported,Yes,2.0,Not Reported,,01/23/2021,01/24/2021,1.0,PHM,"Levothyroxin once a day, Losartan once day, Digoxin once a day, Furosemide once a day, Memantine twice daily, Eliquis twice a day, Metoprolol once a day , Multivitamin for women over 55+",,"mild dementia, Afib",,Not that I am aware of,"['Anger', 'Blood test normal', 'Condition aggravated', 'Confusional state', 'Dementia', 'Disorientation', 'Emotional distress', 'Magnetic resonance imaging normal', 'Speech disorder', 'Urine analysis normal']",1,PFIZER\BIONTECH,SYR 981553,SC,71.0,F,coughing; severe difficulty breathing; itching of inner ear; rash around neck; headache,Not Reported,,Yes,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,PHM,Levathoroxin,,hypo thyroid,,,"['Cough', 'Dyspnoea', 'Ear pruritus', 'Headache', 'Hypersensitivity', 'Rash']",1,MODERNA, 981568,IL,92.0,M,"Received vaccine on 1/26/2021 at 10:30am and at 2134 was observed to be having difficulty with breathing and cyanotic when staff entered his room. He was coughing and sounded congested. He was repositioner and SPO2 78% on room air so O2 applied at 2L which increased SPO2 88% so O2 increased to 4L and SPO2 increased to 95%. Temp 103.1, B/P 188/110, resp 28, pulse 128. 911 called and sent to Community Hospital ER at 2145. Received call from hospital reporting diagnosis of right sided pneumonia. He had received his 1st dose on 12/29/2020. On 1/8/2021 he was on droplet isolation due to possible exposure of Covid 19 and receiving duoneb treatments for chronic nonproductive cough.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/26/2021,01/26/2021,0.0,SEN,"atorvastatin, flomax, tylenol, miralax,lasix, duoneb",see response to 12,"Alzheimer's, Hypertension,ASHD, Hyperlipidemia, BPH, Prostate Cancer. 11/2/2020 Covid-19",,"Aricept, Exelon","['Body temperature increased', 'Breath sounds abnormal', 'Cough', 'Cyanosis', 'Dyspnoea', 'Pneumonia']",2,MODERNA,IM 981582,NH,63.0,F,"Patient received her vaccine on Thursday, 1/21/21. From then until Saturday afternoon she had been experiencing extreme fatigue. On Sat. around 5:00 PM she was standing at her flat-top stove cooking dinner. A wave of very extreme fatigue came over her, so she leaned over to turn off the burner. When she did this, she passed out leaning forward with her hand on the burner and touching the frying pan. When she came to, she went to the couch and laid down - not realizing for 10 minutes that her hand and right breast were burned. The resulting injuries lead to her having to see her PCP on Monday, and then a General Surgeon on Weds 1/27/21. Injuries sustained include a second degree burn on her right breast, On the right arm, laterally above the wrist is a small superficial partially healed burn. On the dorsal aspect of the right fifth finger there is a longitudinal burn that goes from the MCP joint to almost the tip of the finger. She has limited range of motion due to discomfort and swelling. The blister encompasses the entire dorsal lateral aspect of the finger. The fourth right finger has a less extensive blistered area on the PIP joint. The burn on the fifth finger is deep second degree.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/21/2021,01/23/2021,2.0,PVT,Hydrodiuril 25 mg metoprolol succinate XL 25 mg Advair Diskus Decadron drops 1% Albuterol inhaler,,Allergic Asthma Hypertension Pre-diabetes BMI > 40,,metronidazole,"['Burns second degree', 'Discomfort', 'Fatigue', 'Loss of consciousness', 'Mobility decreased', 'Swelling', 'Thermal burn']",1,PFIZER\BIONTECH,IM 981604,FL,60.0,M,"Approximately 5 hours after my injection, I started to feel fatigue. Went to bed, awoke around 0039 1/26/2021 with mild shortness of breath and slight chest pressure. Around 0500 I started with chills, muscle, joint, bone pain. I went back to bed and awoke around 1200 with throat tightness, SOB, chest pressure and diaphoretic accompanied by the other symptoms. I went to my local ER.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/25/2021,01/25/2021,0.0,WRK,"testosterone, Crestor, Anastrozole, omeprazole, Trulicity, Jaurdiance",Positive Covid result 1/6/2021,"Asthma, Barretts, Type 2 diabetes. prostate cancer",,Metformin. Atorvastatin. IVP,"['Arthralgia', 'Bone pain', 'Chest X-ray', 'Chest discomfort', 'Chills', 'Dyspnoea', 'Electrocardiogram', 'Fatigue', 'Hyperhidrosis', 'Laboratory test', 'Myalgia', 'Throat tightness']",2,MODERNA,IM 981640,TX,38.0,F,"I received my 1st dose of the moderna vaccine on 1/20/21 around 9:15am. I had normal site soreness and a very small raised area. All that went away within 3-4 days. Yesterday 1/27/21, exactly 1 week after my injection I noticed a larger raised area that was raised, red, warm to the touch and slightly itchy. The area is currently around 2""x1"". I am 38 years old and pregnant with our second child. I received the 1st dose at 33 weeks and 5 days pregnant. Today we are 34 weeks and 6 days. Baby's estimated due date is March 5, 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/27/2021,7.0,OTH,Prenatal Vitamin Iron Vitamin D3 Progesterone,,,,Sulfa Drugs,"['Exposure during pregnancy', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",2,MODERNA,SYR 981653,MI,41.0,M,received dose 1 at 8:40am and woke up the next morning at 7am with hearing loss in left ear and constant ringing in the left ear. have never had this issue before.,Not Reported,,Not Reported,Not Reported,,Yes,N,01/11/2021,01/12/2021,1.0,PVT,None,None,None,,amoxacillin,"['Deafness unilateral', 'Middle ear effusion', 'Tinnitus']",1,PFIZER\BIONTECH,IM 981746,AR,82.0,F,Pt in CCU with Covid,Not Reported,,Yes,Yes,3.0,Not Reported,N,01/05/2021,01/26/2021,21.0,SEN,,,,,,"['COVID-19', 'Intensive care']",1,MODERNA,IM 981787,WI,61.0,M,"pulmonary embolism that presented with chest pain and inability to take a deep breath, admitted and started on Heparin drip. Patient transitioned to Apixiban.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/19/2021,01/28/2021,9.0,PVT,"Simvastatin, lisinopril",None,"Hypertension, hyperlipidemia",,none,"['Chest pain', 'Computerised tomogram thorax abnormal', 'Fibrin D dimer increased', 'Hypopnoea', 'Lung opacity', 'Pleural effusion', 'Pulmonary embolism', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 981790,NC,82.0,M,Systemic: Other- Death,Yes,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,SEN,,,,,NKA listed on form,['Death'],1,MODERNA,IM 981812,FL,35.0,F,"1/2/2021 vaccination. Observation for 15 min. Felt light headed, feverish. Lasted for about a couple days. 1/2/2021 ER; administered saline / 3 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/02/2021,01/02/2021,0.0,PUB,BC; vitamins,,low BP,,,"['Blood test normal', 'Dizziness', 'Electrocardiogram normal', 'Pyrexia']",1,MODERNA,SYR 981825,WI,68.0,F,"Patient presented to the ED on 1/21/21 for evaluation of SOB stating her husband tested positive for COVID earlier that week and she has been around him. The patient states her symptoms started 3-4 days prior to presentation. She admits to cough, nausea, and an episode of vomiting the day of presentation. She had been intermittently using her husband's oxygen prior to presentation which she says has helped with her symptoms, but does not use oxygen at baseline. Upon presentation the patient's oxygen saturation rate on room air is 89%. Patient was placed on 2L oxygen via nasal cannula and then was saturating in the mid 90s. CXR demonstrated bilateral patchy infiltrates in the ED which the ED physician felt to be consistent with COVID infection. The patient's rapid COVID test resulted as positive. The patient was admitted to the hospital for further management of hypoxia related to COVID infection. The patient remains hospitalized on the day of report submission (1/28/21)",Not Reported,,Not Reported,Yes,,Not Reported,N,12/30/2020,01/18/2021,19.0,PVT,"anastrozole, cholecalciferol, cyanocobalamin, Lomotil, Lexapro, fenofibrate, Atarax, Basaglar, Imodium, Metrogel, magnesium, Singulair, Protonix, Compazine, Inderal LA, Zocor",,"Agranulocytosis secondary to cancer chemotherapy, Antineoplastic chemotherapy induced pancytopenia, Anxiety, Depression, Diabetes, Fibromyalgia, GERD, Hyperlipidemia, Malignant neoplasm of nipple and areola of female breast, Migraine, PONV",,"codeine (N/V), adhesive tape (pruritis/rash)","['Chest X-ray abnormal', 'Cough', 'Dyspnoea', 'Exposure to SARS-CoV-2', 'Hypoxia', 'Lung infiltration', 'Nausea', 'SARS-CoV-2 test positive', 'Vomiting']",1,PFIZER\BIONTECH,IM 981827,,37.0,M,"Received vaccination at 1546, at approximately 1925 he was evaluated by medical staff for hives, vomiting, and difficulty breathing. He was treated on site by medical with diphenhydramine IV, methylprednisolone sod succinate IV, albuterol sulfate neb soln, and ipratropium inhalation soln. Following treatment he was still with difficulty swallowing and was sent to the ER via ambulance and remains there at this time (1/28/21, 0839)",Not Reported,,Not Reported,Yes,,Not Reported,U,01/27/2021,01/27/2021,0.0,OTH,"Albuterol inhal, famotidine, gabapentin, HCTZ, cholecalciferol, ibuprofen, mometasone furoate inhal, phenytoin",,"Vita D deficiency, hyperlipidemia, anxiety disorder, PTSD, seizure disorder, HTN, Asthma, GERD",,none known,"['Dysphagia', 'Dyspnoea', 'Urticaria', 'Vomiting']",1,MODERNA,IM 981849,IN,92.0,M,died 01/16/2021,Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/16/2021,3.0,PUB,unknown,unknown,unknown,,unknown,['Death'],UNK,MODERNA,IM 981851,AZ,43.0,M,"A few days after injections, noticed when I lift my arm, lift items or stretch, now get a pinched/pulling sensation in the palm of my left hand.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/11/2021,01/14/2021,3.0,OTH,"Synthroid, liothronine, testosterone,",None,,,None,"['Pain', 'Sensory disturbance']",1,PFIZER\BIONTECH,SYR 981912,CA,67.0,F,"Patient presented to the Emergency Department complaining of chest pain, pale, cool diaphoretic, and hypotensive. The patient was discovered to have a large saddle pulmonary embolism, went into cardiac arrest and expired. Of note, the patient received her second Moderna COVID vaccine on 1/23, which would place her first one approximately 12/25 if she received them at the appropriate interval. This information is from the patient's daughter and the ED record, the information is not available in CAIR. Per the daughter, the patient started feeling ill on 1/21, improved on 1/25, and then acutely worsened on 1/27, resulting in the ED visit.",Yes,01/27/2021,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/23/2021,0.0,UNK,"albuterol, fluticasone nasal spray, hydrochlorothiazide, losartan",,hypertension,,none,"['Angiogram pulmonary abnormal', 'Cardiac arrest', 'Chest pain', 'Cold sweat', 'Death', 'Endotracheal intubation', 'Hypotension', 'Laboratory test', 'Pallor', 'Pulmonary embolism']",2,MODERNA,IM 981914,GA,53.0,M,"Moderna COVID?19 Vaccine EUA Dr. received Covid-19 vaccine on January 11, 2021 in his office. Dr. reported complaints of abdominal discomfort to his staff starting on January 13 or 14th. Pain and condition worsened. By January 19th, running fever 103.9 F, oral. Labs showed elevated white count. On January 20th, follow up labs and KUB done. Elevated white count and Appendicits diagnosed. Also on January 20th, emergency consult done and emergency surgery done to remove appendix. Reports of Appendicitis noted on follow-up research. Even though reports stated unknow correlations between Covid-19 vaccine and Appendicitis, VAERS report done as precaution.",Not Reported,,Not Reported,Yes,7.0,Not Reported,,01/11/2021,01/20/2021,9.0,PVT,None known,None reported.,None reported,,NKDA,"['Abdominal discomfort', 'Appendicectomy', 'Appendicitis', 'Laboratory test abnormal', 'Pain', 'Pyrexia', 'Urinary system x-ray abnormal', 'White blood cell count increased']",UNK,MODERNA,IM 981915,CA,38.0,F,"Complex migraine with neurological symptoms: numbness to R upper extremity, trouble speaking. Patient presented to Emergency Dept. Sxs resolved in one hour.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/19/2020,12/19/2020,0.0,PVT,,,,,,"['Aphasia', 'Hypoaesthesia', 'Migraine', 'Neurological symptom']",1,PFIZER\BIONTECH,UN 981928,PR,51.0,F,"Sepsis, Acute Pancreatitis, Respiratory Failure on Mechanical Ventilation, Disseminated Intravascular Coagulation, Pneumonia, Acute Kidney Injury. Refractory Hypoglycemia",Not Reported,,Yes,Yes,,Yes,N,01/08/2021,01/09/2021,1.0,OTH,"Benadryl 50mg PO HS, Duloxetine 30mg POD, Folic Acid 1mg POD, Gabapentin 300mg POD, Gemfibrozil 600mg POD, methotrexate 2.5mg PO weekly, Prednisone 5mg POD, Propranolol 80mg POD, Sulfasalazine 1gm POD",,"rheumatoid arthritis, fibromyalgia, essential tremors, unspecified cardiac arrhythmia, anxiety",,,"['Activated partial thromboplastin time prolonged', 'Acute kidney injury', 'Alanine aminotransferase increased', 'Albumin globulin ratio decreased', 'Amylase normal', 'Anion gap increased', 'Aspartate aminotransferase increased', 'Basophil count increased', 'Basophil percentage', 'Blood albumin normal', 'Blood alkaline phosphatase increased', 'Blood bilirubin increased', 'Blood calcium decreased', 'Blood chloride normal', 'Blood cholesterol normal', 'Blood creatine increased', 'Blood creatinine increased', 'Blood glucose increased', 'Blood lactate dehydrogenase increased', 'Blood osmolarity increased', 'Blood potassium decreased', 'Blood smear test abnormal', 'Blood sodium normal', 'Blood urea increased', 'Carbon dioxide decreased', 'Disseminated intravascular coagulation', 'Eosinophil count decreased', 'Eosinophil percentage decreased', 'Gamma-glutamyltransferase increased', 'Globulin', 'Glomerular filtration rate decreased', 'Haematocrit decreased', 'Haemoglobin decreased', 'Hypoglycaemia', 'Immature granulocyte count increased', 'International normalised ratio increased', 'Lipase normal', 'Lymphocyte count decreased', 'Lymphocyte percentage decreased', 'Mean cell haemoglobin increased', 'Mean cell volume increased', 'Mean platelet volume normal', 'Mechanical ventilation', 'Monocyte count normal', 'Monocyte percentage decreased', 'Neutrophil count increased', 'Neutrophil percentage increased', 'Pancreatitis acute', 'Platelet count decreased', 'Pneumonia', 'Protein total decreased', 'Prothrombin time prolonged', 'Red blood cell count decreased', 'Red blood cell nucleated morphology', 'Red cell distribution width increased', 'Respiratory failure', 'Sepsis', 'White blood cell count increased']",1,MODERNA,IM 981932,CO,74.0,M,Systemic: Other- Patient became dizzy causing him to fall. Pt had no injuries from the fall but paramedics/ fire dept came and took him to the hospital for further evaluation. No definitive explanation for fall.,Not Reported,,Not Reported,Yes,,Not Reported,U,01/27/2021,01/27/2021,0.0,SEN,,,,,,"['Dizziness', 'Fall']",3,PFIZER\BIONTECH,IM 981952,OK,44.0,F,"on the evening of 1/11/21 pt started to talk to her children and she ""could not access the words."" Then she tried to text and couldn't figure out the vocabulary. She went to the ER where she was transported to hospital, under stroke protocol. She also c/o right hand numbness at the er. She was admitted and test run. No evidence of a stroke.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/05/2021,01/11/2021,6.0,OTH,none,none,none,,NKDA,"['Aphasia', 'Computerised tomogram', 'Hypoaesthesia', 'Magnetic resonance imaging', 'Scan with contrast']",2,PFIZER\BIONTECH,IM 982042,,,F,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable Other HCP (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient was supposed to go back on 13Jan2021 for second dose, but the week before, in Jan2021, she tested positive COVID-19. She had an appointment for the 15Jan2021. The patient wanted to know how many days she has to wait to get second dose. Information on Lot/ Batch number requested.; Sender's Comments: The PFIZER-BIONTECH COVID-19 VACCINE provides protection after three weeks from the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/01/2021,9.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 982160,SC,,F,"Pfizer BioNTech Covid 19 vaccine = treatment under Emergency Use Authorization(EUA): Patient presented to Covid Vaccine Clinic. Appointment time was 0925. Patient indicated she did have allergies on her screening sheet. Pfizer- BioNTech Covid-19 vaccine (0.3ml) was administered per protocol (Lot # EL3246, exp. date 04/30/21). At 0947 I was asked to come assess patient by the monitor. Patient reported her tongue felt thick and the roof of her mouth felt weird. I asked if her throat felt tight, if she had any shortness of breath or chest tightness. She denied any other symptoms. I asked if she had any allergies. Patient reported having a reaction in the past to adhesive from EKG leads, codeine, and contrast dye. I asked patient to pull her mask down. No swelling was observed around her mouth, lips, or tongue at that time. No hives were observed on her arms, chest or back. Patient than started to complain of feeling worse and had some tightness in her chest. At that time I escorted patient to a cot and advised I was going to administer an epi-pen. Patient verbalized understanding. I advised staff to call 911. At 0955 0.3 mg of epinephrine was administered into her left anteriolateral thigh. HR was 88 bpm at this time. Patient reported feeling shaky and felt like her heart was racing. I advised her that was a normal reaction to the epinephrine. Symptoms at this time did not progress. Patient reported her chest felt less tight at 10:05. EMS arrived and reported on 02 sat of 97% on room air. Patient was transported to the ED without further incident on location. Husband was present at all times and informed on all action taken.",Not Reported,,Not Reported,Yes,,Not Reported,,01/21/2021,01/21/2021,0.0,UNK,,,,,"Allergy to adhesives (rash), codeine (itching), erythromycin base (rash), iodinated contrast media (anaphylaxis), latex (rash), metoclopramide hcl (anxiety), oxycodone (rash), tetracycline (rash)","['Chest discomfort', 'Nervousness', 'Palpitations', 'Stomatitis', 'Tongue disorder']",UNK,PFIZER\BIONTECH,IM 982191,,64.0,M,"Patient lives in a SNF and received the first dose of the COVID-19 vaccine 1 day prior to admission. After the vaccine, patient had multiple rounds of vomiting. The next morning, patient was sent to emergency department for continued vomiting. On assessment, patient was found to have right sided opacities on chest x-ray. Patient was afebrile, with a normal WBC, and had mild increase in his chronic oxygen requirement. It was thought that these right sided opacities could be aspiration pneumonitis/pneumonia from the recurrent vomiting in a bed bound SNF patient. Vomiting leading to aspiration pneumonitis/pneumonia. Idiosyncratic response not expected from normal pharmacological mode of action (MOA) vomiting post vaccine leading to aspiration. Vomiting does appear to be linked to receipt of vaccine given timing. Of note, patient had COVID-19 requiring hospital admission approximately 1 month before receiving the COVID-19 vaccine. It is possible that the recent COVID-19 infection contributed to a worsened response to the COVID-19 vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,,,,,UNK,"symbicort, spiriva, albuterol neb, bumetanide, hydralazine, atorvastatin, aspirin, COVID-19 vaccine (first dose)",,"Asthma; Coronary artery disease (CAD); Diabetes mellitus (DM); Hypertension (HTN); Renal Disease (e.g. CKD, HD, ESRF); Pertinent other, pulmonary hypertension, HFpEF",,,"['Chest X-ray abnormal', 'Lung opacity', 'Pneumonia aspiration', 'Vomiting', 'White blood cell count normal']",1,UNKNOWN MANUFACTURER,IM 982218,MO,63.0,M,"resident was on hospice, chronically ill w dementia, COPD, HTN, failure to thrive, passed away 1/13/21. Not certain injection related as he was declining already.",Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/13/2021,5.0,SEN,"On hospice: morphine, ativan, trazodone, tylenol","failure to thrive, pressure ulcer, pneumonitis d/t aspiration, dementia, COPD, alzheimer's disease,","HTN, see above",,aspirin: severe unknown reaction,['Death'],1,MODERNA,IM 982227,NY,73.0,M,On 1/19/21 I started to experience double-vision with both eyes open. My left eye crossed towards the nose. The diplopia goes away when I cover either eye. My primary physician referred me to a neuro ophthalmologist who diagnosed sixth cranial nerve palsy.,Not Reported,,Not Reported,Not Reported,,Yes,N,01/15/2021,01/19/2021,4.0,PHM,"amLODIPine 5mg, aspirin 81 mg, atorvastatin 80mg, decussate sodium 100 mg (x2), Losartan, metoprolol 25 mg (x2), finasteride 5 mg, tadalafil 5 mg, tamsulosin 0.4 mg, Oxybutynin 10 mg",Sinus headache,"Arthritis, high bp, cholesterol, large prostate",,Sulfa drugs,"['Diplopia', 'Magnetic resonance imaging brain', 'Metabolic function test', 'Strabismus', 'Ultrasound Doppler', 'VIth nerve paralysis']",1,MODERNA,IM 982276,CA,69.0,M,"Pt came to tx a/o x4. Pt given COVID-19 Moderna vaccine at around 1545, then RN checked on pt at 1600, and pt not verbally responsive. Pt BP in the low 100's. Pt able to open eyes, but very lethargic. Pt placed supine, given 2l 02 via, breathing unlabored, hr ok, about 600 cc ns bolus given. Pt still not responding verbally. RN noted body twitching/shaking. Paramedics called and transferred to ER at around 1615. The patient did not require the use of an Epi pen . Patient spent the night in the hospital. It was reported that he had elevated Ammonia levels which may have caused this issue. However as this happened so close to the vaccination we are reporting",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/25/2021,01/25/2021,0.0,OTH,,,"ESRD,CAD,HLD, HTN, Hep C cirrhosis, liver hemangioma",,Ibuprofen,"['Ammonia increased', 'Lethargy', 'Muscle twitching', 'Tremor', 'Unresponsive to stimuli']",1,MODERNA,IM 982340,FL,27.0,F,"Patient reports that approximately 10 hours after receiving 2nd dose of Moderna COVID vaccine, she experienced arm pain, fatigue, low grade fever and nightsweats and dizziness with strange sensation in chest. The following morning (<24 hours after dose), she presented to ED with sinus tachycardia (rates ranging 114 - 136). She started continuous IV fluids and got 2 saline boluses. Symptoms improved dramatically the second night after the vaccine. No medication was needed to improve heart rate or treat dizziness.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/26/2021,01/26/2021,0.0,WRK,none,none,none,,none,"['Chest discomfort', 'Dizziness', 'Fatigue', 'Night sweats', 'Pain in extremity', 'Pyrexia', 'Sinus tachycardia']",2,MODERNA,IM 982354,,91.0,M,patient received COVID vaccine on 12/29/2020 and passed away on 1/23/2021,Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/23/2021,25.0,SEN,,,,,,['Death'],UNK,MODERNA, 982370,KY,93.0,M,Patient died at hospital on j/16/2021 approximately 48 after receiving vaccination. Believe death related to fall at home prior to vaccination.,Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/16/2021,2.0,OTH,,Patient fell at home night before vaccination.,,,,['Death'],UNK,MODERNA,IM 982417,KS,89.0,F,Resident tested positive for COVID on 1/7/2021.,Yes,01/14/2021,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/07/2021,8.0,SEN,,"This person had been on HOSPICE for Failure to Thrive since November 2019. She was treated for weight loss with nutritional supplements and served meals of her choice. She had noted increase in sleep in weeks prior to death, but would have times she wanted out of bed for meals and to attend some activity.",,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH,IM 982427,MN,93.0,F,"Weakness, dehydration, renal failure, UTI",Not Reported,,Not Reported,Yes,,Not Reported,U,12/29/2020,01/27/2021,29.0,PUB,"hydralazine, Asa, Lisinopril, Colace",No acute illness,"Hypertension, constipation",,NKDA,"['Asthenia', 'Dehydration', 'Electrocardiogram', 'Full blood count', 'Metabolic function test', 'Renal failure', 'Troponin', 'Urinary tract infection', 'Urine analysis']",UNK,MODERNA,SYR 982439,CA,29.0,F,"I was 11weeks and 2 days pregnant at time of injection. EDD 08/15/2021. The day after my vaccine, I had fever, chills, bodyaches, headache and fatigue. The following day, I woke up with a rash just on my face. It is not itchy or painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/28/2021,2.0,UNK,"Levothyroxine, Pre-natal, ASA and Vitamin D",,"Hypothyroidism, Migraines",,NKDA,"['Chills', 'Exposure during pregnancy', 'Fatigue', 'Headache', 'Pain', 'Pyrexia', 'Rash']",UNK,MODERNA, 982448,MN,93.0,F,"Weakness, renal failure, dehydration, uti",Not Reported,,Not Reported,Yes,,Not Reported,U,01/26/2021,01/27/2021,1.0,PUB,"Lisinopril, Hydralazine, Asa, Colace",No reported illness,"Hypertension, constipation",,NKDA,"['Asthenia', 'Chest X-ray', 'Dehydration', 'Electrocardiogram', 'Full blood count', 'Metabolic function test', 'Renal failure', 'Troponin', 'Urinary tract infection', 'Urine analysis']",UNK,MODERNA,SYR 982472,NJ,72.0,M,Worsening respiratory failure 1/20/2021 death 1/27/2021,Yes,01/27/2021,Yes,Yes,6.0,Not Reported,N,01/19/2021,01/20/2021,1.0,PVT,"Eliquis, Lasix, metoprolol","Chf, CKD","CHF, CKD, DM",,None,"['Death', 'Respiratory failure']",1,MODERNA,IM 982495,OK,65.0,M,"Client's sister called crying and said the family just found out yesterday that Client had died some time last week. The last time any family talked to him was on the 19th of January, missed calls show on the phone on the 21st. His last internet search was sternum pain. . She will also call the Agency and report this. The vaccine isn't in Registery at this time, do I don't know the lot number but she said he was due back in one month. She said he was very healthy and ran triathalons.",Yes,01/27/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/19/2021,4.0,PUB,diclofenac,none,none,,NKDA,['Death'],1,MODERNA,IM 982517,,66.0,M,patient received COVID vaccine on 1/11/2021 and passed away on 1/25/2021,Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,,01/11/2021,01/25/2021,14.0,SEN,,,,,,['Death'],UNK,MODERNA, 982541,IL,81.0,M,"36 hours after vaccination, the patient had increased respiratory distress. He was placed on high flow nasal cannula oxygen with mild improvement. He then continued to be hypotensive requiring IV fluids and subsequently IV vasopressors. Patient's BP was stabilized with vasopresor, however he continued to deteriorate clinically with altered mental status and lethargy, concerned for bowel peroration based on physical exam by MD. He was then emergency intubated and placed on mechanical ventilation. He was then transferred to acute care hospital near by.",Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/24/2021,2.0,PVT,,COVID pneumonia 12/2020,"Coronary artery disease s/p PCI prxima and mid left circumflex in July 2011, carotid stenosis, peripheral vascular disease, dyslipidemia, hypertension",,,"['Endotracheal intubation', 'General physical health deterioration', 'Hypotension', 'Lethargy', 'Mechanical ventilation', 'Mental status changes', 'Respiratory distress']",1,MODERNA,IM 982610,,68.0,M,"Cough and shortness of breath with fever, began day after vaccination. COVID PCR negative. Required brief hospitalization for evaluation.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/24/2021,01/25/2021,1.0,UNK,Gemcitabine,,Pleomorphic sarcoma of upper back with lung metastases,,Sulfa antibiotics,"['Cough', 'Dyspnoea', 'Pyrexia', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH, 982641,TX,56.0,F,"On Sunday, 1/17/21, patient was nauseous and vomiting and could not keep anything down at one point vomit was dark in appearance. Patient receives home dialysis when nurse came to home on Monday, 1/18, saw condition of patient and sent them to the hospital. At the hospital it was noted she had redness throughout body, no hives or blisters. Patient was lethargic, received antiemetic and medication for rash, does not know what medications were. On Tuesday, 1/19, she received 2 liter transfusion, discharged on Thursday, 1/21. Today, Thursday 1/28 patient still feels lethargic and states rash is peeling.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/16/2021,01/17/2021,1.0,OTH,"Clonidine 0.2 mg BID, Carvedilol 25 mg BID, Glipizide 10 mg QD, Vitamin D 50000 units weekly, Pioglitazone 30 mg daily, Sevelamir carbonate 800 mg take 3 with meals, Renavite 1 tablet daily, Toujeo (insulin glargine) 50 units daily","Anemia diagnosed on 1/14/21 was given injection by dialysis clinic, patient unable to recall name.","Hypertension, diabetes mellitus type 2, Chronic Kidney disease, stage 5, anemia, psoriasis",,"Methotrexate - rash, and shellfish","['Discoloured vomit', 'Erythema', 'Feeding disorder', 'Lethargy', 'Magnetic resonance imaging', 'Mental status changes', 'Nausea', 'Rash', 'Red blood cell count decreased', 'Skin exfoliation', 'Transfusion', 'Vomiting']",1,PFIZER\BIONTECH,IM 982671,NC,49.0,F,"Patient received COVID19 vaccine on 1/26/21 (mfg unknown); headache started 1/27/21 at 2pm. Patient had headache and tiredness and diarrhea and body aches after 2nd dose covid vaccine. Symptoms progressed to severe headache associated with N/V, dizziness that started 1/28@0800am. The patient admitted to Emergency Room at Hospital on 1/28/21 and diagnosed with aneurysmal subarachnoid hemorrhage. Patient transferred to Medical Center for care.",Not Reported,,Not Reported,Yes,,Not Reported,,01/26/2021,01/27/2021,1.0,UNK,,,,,,"['Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Ruptured cerebral aneurysm', 'Vomiting']",UNK,PFIZER\BIONTECH, 982736,MN,81.0,F,STEMI,Not Reported,,Not Reported,Yes,,Not Reported,Y,01/27/2021,01/27/2021,0.0,PVT,atenolol,stroke,borderline diabetes,,none,"['Acute myocardial infarction', 'Angiogram']",1,PFIZER\BIONTECH,IM 982826,NV,40.0,M,"Was at work on 1/26/21 and collapsed, no known complaints a the time. CRP was initiated immediately, transported to ER and pronounced dead",Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/26/2021,5.0,PUB,unknown,immunocompromised with reportable conditions,"immunocompromised with reportable conditions, positive for COVID-19 September 2020",,unknown,"['Death', 'Resuscitation', 'Syncope']",1,PFIZER\BIONTECH,IM 982851,IL,61.0,F,"Patient has temperature the day after the vaccine (1/23/2021), then felt better. On Monday developed chest pain and palpitations. Admitted to hospital.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/22/2021,01/25/2021,3.0,PVT,Klonopin,Anxiety,Anxiety,,NKDA,"['Blood creatine phosphokinase', 'Chest X-ray', 'Chest pain', 'Full blood count', 'Metabolic function test', 'Palpitations', 'Pyrexia', 'SARS-CoV-2 test', 'Troponin']",1,MODERNA,IM 982866,MS,68.0,F,"One week after taking the vaccine I developed significant swelling of the upper left arm at the vaccination site that gradually got worse as the day progressed. I also experienced a headache and a severe spike in blood pressure in the afternoon, which led me to think that my reaction might be severe. As a result I went to the local ER where they decided to keep me overnight for observation. The symtoms did not get worse, but I was given steroids and peptid intravenously, as well as Benadryl to counteract the swelling. Today, Jan. 28, I continue to have some swelling in the left arm, as well as redness.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/19/2021,01/26/2021,7.0,PUB,simvastatin 20mg losartan 50mg rizatriptan 5mg (as needed) calcium/D3 Prolia,None,High blood pressure,,"Had an allergic reaction to shrimp in my 20's, but presently eat shrimp with no adverse effects","['Blood pressure increased', 'Headache', 'Injection site erythema', 'Injection site swelling']",1,MODERNA,SYR 982890,MS,67.0,M,"Pt presented to ER via EMS at 1556 3 days after receiving vaccine. pt was breathing approximately 50 times a minutes and o2 sats in the 70's upon arrival. NP decided to intubate, Rocuronium and Versed given. Pt became bradycardic and 1 amp of Atropine was given without improvement. No pulse felt, CPR started per ACLS protocol. 7 Epi's given. Time of death- 1632. After TOD pt was swabbed for COVID-19 and the results were positive.",Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/25/2021,3.0,PVT,Crestor 10 mg po daily Norvasc 10 mg po daily benazepril 20 mg po daily Gabapentin 600 mg po daily Toprol XL 100 mg po daily,GI Bleed and Anemia- DX: 1/31/2021,"ASCVD, HTN, Blindness, Diverticulous",,No Known Drug Allergies,"['Bradycardia', 'Death', 'Endotracheal intubation', 'Pulse absent', 'Resuscitation', 'SARS-CoV-2 test positive', 'Troponin increased', 'White blood cell count increased']",1,MODERNA,IM 982891,KS,61.0,M,"All residents had been in isolation due to multiple cases of COVID in the facility. Resident voiced no health related complaints. He continued to visit with staff and required moderate assist with toileting. Resident had fall 0130 on 1-15-2021, which resulted in laceration with surgical repair. Resident was noted to change in mental status and respirations on morning of 1-16-2021 during morning blood sugar check. Resident had O2 @1.5l/m via n/c and respirations of 10 with periods of apnea and unresponsive to verbal stimuli. Blood sugar was 583. Resident deceased upon re-check after calling PCP to report status change.",Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,SEN,,,"Heart Failure, unspecified, Acute and Chronic Respiratory Failure with Hypercapnia, Chronic Obstructive Pulmonary Disease, Morbid (Severe) Obesity with Aveolar Hypoventilation, Essential Hypertension, Type 2 Diabetes Mellitus with Diabetic Neuropathy, Hypothyroidism, Obstructive Sleep Apnea",,NKDA,"['Apnoea', 'Blood glucose increased', 'Death', 'Exposure to SARS-CoV-2', 'Fall', 'Mental status changes', 'Respiration abnormal', 'SARS-CoV-2 test negative', 'SARS-CoV-2 test positive', 'Skin laceration', 'Unresponsive to stimuli', 'Wound closure']",1,PFIZER\BIONTECH,IM 982895,TX,44.0,F,"Severe muscle pain, kidney pain,shaking for a week.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PHM,BYSTOLIC,none,kidney hydronephrosis,Moderna,none,"['Myalgia', 'Renal pain', 'Tremor']",1,MODERNA,IM 982911,PA,79.0,F,"Patient presented to hospital 1 day following vaccination with slurred speech, left sided weakness, and left gaze preference concerning for acute neurologic injury.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/26/2021,01/27/2021,1.0,PVT,"Diclofenac, Gabapentin, Clopidogrel, Simvastatin, Symbicort, Timolol ophthalmic, Restasis ophthalmic",None,"Hypertension, hyperlipidemia, glaucoma, Transient ischemic attack, spinal stenosis, pancreatic lesion, abnormal fasting glucose, rectal bleed",,No known allergies,"['Dysarthria', 'Gaze palsy', 'Hemiparesis', 'Imaging procedure', 'Laboratory test']",1,PFIZER\BIONTECH, 982929,MD,61.0,F,"Client was being treated with antibiotics by her PCP for diverticulitis flare up. It had not been resolved on the date of her death which occurred 01/27/21, She was found unresponsive by staff, 911 contacted, and paramedics pronounced her deceased at 7:48 AM. After consultation with PCP manner of death was noted as cardiac arrest. PCP was to sign off on death certificate.",Yes,01/27/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/27/2021,28.0,WRK,"Cetirizine 10 mg, Haloperidol 5 mg, Sertraline 50 mg, Albuterol HFA 90 mcg (PRN), Diphenhydran 25 mg (PRN), Fluticasone 50cg PRN, Lactulose 10 gm/15 (PRN), Polyeth Glycol 17 gm (PRN), Neomycin/Polymyxin drop, Amoxicillan 500 mg, Methyldredn",Ongoing Sinus and ear infections being treated by PCP,"COPD, Hypothyrodism, non-alcoholic fatty liver, diabetes type 2, hypertension, diverticulitis",,"Quetiapine, Zyprexa","['Cardiac arrest', 'Condition aggravated', 'Death', 'Diverticulitis', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 982942,AZ,57.0,M,per recipient spouse - vaccine recipient became ill during the night of 1/21/21 or early morning of 1/22/21 and was deceased in the morning of 1/22/21.,Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,OTH,unknown,unknown,unknown,,peanuts,"['Death', 'Illness']",1,MODERNA,IM 983040,VA,55.0,F,"Developed immediate fever & cills within 2 hours. By next morning had pain & difficulty producing urine. Saw primary care doctor and urgent care center, infection not treated w/PO Macrobid after 2 days. Admitted to Hospital w/sepsis, kidney infection and acute renal injury?creatinine 4.25 (baseline=1.5)",Not Reported,,Yes,Yes,5.0,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"Envarsus, Cellcept, Bentley, Pepcid, Amlodipine. Crestor, Zoloft, Wellbutrin",Possible silent UTI/kidney infection(?),"S/p bilateral nephrectomies (1987, 2011) S/p right renal transplant, living, unrelated donor 5/17/2011., Polycystic Kidney DS., Depression., Hx of pancreatitis, s/p appendectomy1988, right oopharectomy 2002",,Zestril?angioedema Ampicillin?hives Heparin?heparin induced thrombocytopenia,"['Acute kidney injury', 'Blood creatinine increased', 'Chills', 'Immediate post-injection reaction', 'Kidney infection', 'Pain', 'Pyrexia', 'Sepsis', 'Urine output decreased']",1,MODERNA,IM 983055,OK,85.0,F,"sluggish orientation, fatigue resulting in a fall and hospitalization. possible brain bleed",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/26/2021,01/27/2021,1.0,SEN,,,,,,"['Fall', 'Fatigue', 'Sluggishness']",1,PFIZER\BIONTECH,IM 983111,MN,36.0,F,"Pericarditis :severe, pleuritic chest pain, with subtle T-wave inversions, mildly elevated troponin, elevated CRP and ESR-- developed symptoms approx 50-54 hours after immunization) Also had 36 total hours of severe arthralgias, myalgias, fatigue, fevers and chills.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/25/2021,01/28/2021,3.0,PVT,Rifampin 600 mg daily; Zoloft 100 mg daily,None,"ADHD, anxiety",,"Buproprion, Codeine, Morphine","['Arthralgia', 'C-reactive protein increased', 'Chills', 'Electrocardiogram T wave inversion', 'Fatigue', 'Myalgia', 'Pericarditis', 'Pleuritic pain', 'Pyrexia', 'Red blood cell sedimentation rate increased', 'Troponin increased']",2,PFIZER\BIONTECH,IM 983142,MO,74.0,F,Presented to ED with dizziness and nausea and vomiting and SOB. Na level of 111 (1/27); Cl 82; CO2 17 All other BMP labs WNL. Urine Osmolality 436; urine sodium 89. Admitted to hospital for treatment. Nephrologist states that she has not prior history of hyponatremia (12/1/20 Na was 139),Not Reported,,Not Reported,Yes,,Not Reported,N,01/22/2021,01/27/2021,5.0,PVT,Asa 325; atorvastatin 40mg lisinopril 5mg bid; lantus 10 units daily; mvi daily; Levothyroxine 50 mcg,,HTN; TIA; Hypothyroidism; DM2,,Shellfish,"['Blood chloride decreased', 'Blood sodium decreased', 'Carbon dioxide decreased', 'Dizziness', 'Dyspnoea', 'Nausea', 'Urine osmolarity normal', 'Urine sodium normal', 'Vomiting']",1,PFIZER\BIONTECH,IM 983147,NE,55.0,M,"On 12/31,1/1 exp flu like symptoms. Then on 1/3 got dizzy,sweaty and sat down nurse nearby took my pulse 65. The ambulance was called went to a hospital there was no CT scan capability therefore transferred to another hospital.",Not Reported,,Not Reported,Yes,2.0,Not Reported,,12/21/2020,12/31/2020,10.0,PVT,"Synthroid, Losartan, Zyrtec, Aspirin",No,Hypothyroidism,Flu vaccine(flu like symptoms) lasting 12 hrs and feel fine.,No,"['Blood creatinine increased', 'Computerised tomogram', 'Dehydration', 'Dizziness', 'Hyperhidrosis', 'Influenza like illness']",1,PFIZER\BIONTECH,IM 983159,TX,64.0,F,"Patient had left to walk around the store. When patient returned she was not speaking. Patient stumbled into the counter then into the wall. We then caught patient before she could fall on the floor. We placed patient in a chair. Tried to talk to patient but was not responding . Called 911, and which point EMS said patient was having a seizure. EMS then transported patient to the hospital.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/28/2021,01/28/2021,0.0,PHM,,History of seizures.,,,None that the patient reported,"['Aphasia', 'Condition aggravated', 'Gait disturbance', 'Seizure', 'Unresponsive to stimuli']",2,MODERNA,IM 983169,KY,83.0,M,"Client received the COVID-19 vaccine on 1/5/21 by the Vaccine clinic. Plans were for Hospice services. Client tested positive for COVID-19 by rapid testing on 1/8/21. On 1/10/21 at 0900 Client was unresponsive and without vital signs. Orders were for DNR, and CPR was not initiated.",Yes,01/10/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/08/2021,3.0,SEN,"Clopidogrel, Lexapro, Gabapentin, Synthroid, Prilosec, Zinc, Vitamin C, Vitamin D, Tuberculin Skin Test",COVID-19,"Alzheimer's Disease, Dysphagia, AAA, PVD, Neuropathy, RLS, Hypothyroidism HTN, GERD",,"Olanzapine, Risperidone, Aggrenox","['SARS-CoV-2 test positive', 'Unresponsive to stimuli', 'Vital functions abnormal']",1,PFIZER\BIONTECH,IM 983173,KY,86.0,F,"Client recevied the COVID-19 vaccine on 1/5/21 by the Vaccine clinic. Client tested positive for COVID-19 by rapid testing on 1/21/21, with c/o hurting all over and loose stools. She became non-verbal on 1/23/21 with poor intake. On 1/24/21 at 0537 Client was unresponsive and without vital signs. Orders were for DNR, and CPR was not initiated.",Yes,01/24/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/21/2021,16.0,SEN,"Losartan-HCTZ, Memantine, Metformin, Macrobid, Prilosec, Risperidone, Zocor, Detrol, Benedryl, Aspirin, Centrum, Donepezil, Farxiga, Gabapentin, Vitamin B-12, Vitamin D3, Tylenol",COVID-19,"Alzheimer's Disease, Anemia, DM type 2, Hyperlipidemia, HTN, GERD",,Avandia,"['Diarrhoea', 'Hypophagia', 'Pain', 'SARS-CoV-2 test positive', 'Speech disorder', 'Unresponsive to stimuli', 'Vital functions abnormal']",1,PFIZER\BIONTECH,IM 983184,KY,87.0,F,"Patient has been under Hospice services for almost a year. She began to demonstrate a large amount of oral secretions on 1/10/21 at 2130. She was suctioned and a Rapid COVID-19 test was performed, which was negative. The COVID-19 Rapid test was repeated on 1/11/21 and was positive. Oxygen saturation was noted to be 78% on 1/12/21, and oxygen was initiated at 1133 at 3L per nasal cannula. Oxygen was increased to 4L at 1635 d/t shortness of breath. On 1/15/21 @ 0645 patient was unresponsive and without vital signs. Orders were for DNR and CPR was not initiated.",Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/11/2021,6.0,SEN,"Norco, Morphine Sulfate, Levsin",COVID-19,"Alzheimer's Disease, Dysphagia, Anxiety, Ischemic Heart Disease, Hypertension, Hypercholesterolemia",,NKA,"['Airway secretion clearance therapy', 'Dyspnoea', 'SARS-CoV-2 test positive', 'Salivary hypersecretion', 'Unresponsive to stimuli', 'Vital functions abnormal']",1,PFIZER\BIONTECH,IM 983187,KY,92.0,M,Client tested positive for COVID-19 by rapid test on 1/8/21. On 1/9/21 at 1405 his oxygen saturation dropped to 86% and oxygen was initiated at 2L per nasal cannula. A non-productive cough was noted on 1/10/21 and oxygen was increased to 3L. On 1/12/21 Client became non-responsive with 30 second periods of apnea. Dexamethasone was initiated on 1/13/21. Lung sounds were noted with crackles on 1/15/21 at 1158 and at 2120 Client was unresponsive and without vital signs. Orders were for DNR and CPR was not initiated.,Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/09/2021,4.0,SEN,"Allopurinol, Eliquis, Allegra, Synthroid, Sodium Chloride, Trazadone, Zinc, Vitamin C, Vitamin D, Dexamethasone, Tylenol",COVID-19,"Alzheimer's Disease, Dysphagia, Encephalopathy, Syndrome of Inappropriate Secretion of Antidiuretic hormone",,"Risperidone, Memantine, Haldol","['Apnoea', 'Cough', 'Oxygen saturation decreased', 'Oxygen therapy', 'Rales', 'SARS-CoV-2 test positive', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 983189,KY,92.0,F,Patient tested positive for COVID-19 by rapid test on 1/6/21. She began to demonstrate a dry cough on 1/11/21. On 1/12/21 at 1723 her oxygen saturation dropped to 79% and oxygen was applied at 4L per nasal cannula. On 1/19/21 at 2130 Patient was unresponsive and without vital signs. Orders were for DNR and CPR was not initiated.,Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/11/2021,6.0,SEN,"Alprazolam, Amlodipine, Lexapro, Cozaar, Metoprolol, Tylenol",COVID-19,"ASHD, Hyperlipidemia, Hypertension, Dementia, Anxiety, Dysphagia",,Fosomax,"['Cough', 'Oxygen saturation decreased', 'SARS-CoV-2 test positive', 'Unresponsive to stimuli', 'Vital functions abnormal']",1,PFIZER\BIONTECH,IM 983192,KY,89.0,F,Patient recevied the COVID-19 vaccine on 1/5/21 by the Vaccine clinic #1. Patient tested positive for COVID-19 by rapid testing on 1/6/21. She demonstrated poor appetite and fluid/food intake and an IV of Normal Saline was initiated on 1/7/21. Oxygen saturation was initiated on 1/12/21 at 4L per nasal cannula. for shortness of breath. On 1/22/21 at 0310 Patient was unresponsive and without vital signs. Orders were for DNR and CPR was not initiated.,Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,SEN,None,COVID-19,"Alzheimer's Disease, Dysphagia, Dementia",,NKA,"['COVID-19', 'Decreased appetite', 'Dyspnoea', 'Fluid intake reduced', 'Hypophagia', 'SARS-CoV-2 test positive', 'Unresponsive to stimuli', 'Vital functions abnormal']",1,PFIZER\BIONTECH,IM 983193,KY,96.0,F,"Patient began to demonstrate a cough the evening of 1/5/2021, after receiving the COVID-19 vaccine earlier in the afternoon. A rapid COVID-19 test was performed and was positive. She began to demonstrate shortness of breath with exertion on 1/7/21, and lethargy on 1/12/21. Appetite and oral intake began to decline on 1/12/21, and Oxygen saturation dropped on 1/16/21 to 82%, and oxygen was initiated at 3L per nasal cannula. On 1/19/21 at 0414 patient was unresponsive and without vital signs. Orders were for DNR, and CPR was not initiated.",Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,SEN,"Citalopram, Divalproex, Levothyroxine",COVID-19,"Dementia, Atrial Fibrillation, Hypothyroidism, Dysphagia",,"Atorvastatin, Donepezil, Corticosteroids","['Cough', 'Decreased appetite', 'Dyspnoea exertional', 'Hypophagia', 'Lethargy', 'Oxygen saturation decreased', 'SARS-CoV-2 test positive', 'Unresponsive to stimuli', 'Vital functions abnormal']",1,PFIZER\BIONTECH,IM 983293,TN,69.0,F,"FELT A SWOOSH GOING THRU BODY WITHIN 5 MINUTES OF THE VACCINE, STARTED TREMBLING INSIDE AND FELT LIGHT-HEADED. CALLED AN EMT OVER, HE TOOK HEART RATE AND IT HAD SHOT UP 100. CAME ON HOME WITHIN AN HOUR ENDED UP AT MINOR EMERGENCY BECAUSE MY BLOOD PRESSURE HAD GONE UP TO OVER 170. HAVE HAD SHAKING INSIDE AND HIGH BLOOD PRESSURE EVER SINCE. TOOK BENADRYL, DIDN'T REALLY HELP, WENT TO MY PCP AND WAS TOLD TO TAKE CLARITIN. WAS ALSO GIVEN AT THE SECOND URGENT CARE VISIT, AMLODIPINE BUT IT DIDN'T HELP.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/28/2021,01/28/2021,0.0,UNK,Nexium 40mg,"Right sphenoid sinusitis, gastrointestinal reflux and dermatitis.",Right sphenoid sinusitis and gastrointestinal reflux,,"Naproxen, Prednisone (steroids), penicillin, principen, lidocaine, flonase, x-ray contrast.","['Blood pressure increased', 'Dizziness', 'Full blood count normal', 'Heart rate increased', 'Nervousness', 'Sensory disturbance', 'Urine analysis normal']",UNK,MODERNA,UN 983303,IN,74.0,M,Hospital contacted this facility this morning to report that patient was admitted for complaints of Altered Mental Status. Pt's family reports receiving COVID 19 vaccination at facility on 1/26; Per MHP pt.'s family also states that pt received monoclonal antibody infusion within the past 90 days. Pt currently remains inpatient at Hospital. Upon review of pt intake form pt checked NO on if he had received monoclonal antibody infusion. Staff also verbally screen for this question as well.,Not Reported,,Not Reported,Yes,,Not Reported,U,01/26/2021,01/27/2021,1.0,PVT,unknown,denied,none disclosed at time of appointment,,denied,['Mental status changes'],1,PFIZER\BIONTECH,IM 983314,,45.0,F,Received the second vaccine yesterday 1/27/2021 around 11am. About an hour later started to get hives and took a Claritin. Was at home later in the evening around 5pm and started to have lip/jaw swelling and throat tightening. Called an ambulance and they gave her EPI pen and took over treatment. Ended up getting discharged around 11-12pm last night and told to take prednisone and Benadryl. Around 5am today 1/28 had swelling in tongue and bottom lip swelling. Went back to emergency room and they did similar treatment. Is planning to follow up with her doctor and will be on her prescribed medications for a few days.,Not Reported,,Yes,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,PVT,"Omeprazole, rosuvastatin, multivitamin",none,"ADHD, familial hypercholesterolemia",,"Contrast (Iodinated) - anaphylaxis, amoxicillin - hives, clindamycin - hives, doxycycline-hives, sulfa antibiotics-hives","['Lip swelling', 'Swelling face', 'Swollen tongue', 'Throat tightness', 'Urticaria']",2,PFIZER\BIONTECH,IM 983362,CA,25.0,F,"7 Days after receiving the vaccine, patient developed generalized myalgia, fever, shortness of breath, and chest pain. Patient admitted to our hospital on 21JAN and diagnosed with myocarditis. Difficult to elucidate whether the myocarditis was secondary to Moderna vaccination or other viral etiologies.",Not Reported,,Yes,Yes,8.0,Not Reported,Y,01/08/2021,01/13/2021,5.0,PVT,Tylenol,None,None,,None,"['Blood creatine phosphokinase MB increased', 'Chest pain', 'Dyspnoea', 'Electrocardiogram ST segment depression', 'Myalgia', 'Myocarditis', 'Pyrexia', 'Troponin increased']",1,MODERNA,IM 983425,TX,41.0,F,"5 days after 2nd covid vaccine, I started experiencing severe pain, with pins/needles sensation. Started in plantar aspect of both feet and traveled upwards to my hands, in a matter of hours. Extreme pain in lower back and extremities caused me to go to the ER. Following lumbar puncture and a series of diagnostic tests, I have started on IVIG for Acute Inflammatory Demyelinating Polyneuropathy. This is a subtype of Guillain Barre syndrome, believed to be precipitated by autoimmune response generated from the 2nd covid vaccine. I am now on day 4 of my hospitalization.",Not Reported,,Yes,Yes,4.0,Not Reported,N,01/20/2021,01/25/2021,5.0,WRK,,Acid reflux,"History of breast cancer, in remission over 15 years",,,"['Back pain', 'Computerised tomogram head', 'Full blood count', 'Guillain-Barre syndrome', 'Immunoglobulin therapy', 'Lumbar puncture', 'Magnetic resonance imaging neck', 'Metabolic function test', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Viral titre']",1,PFIZER\BIONTECH,IM 983428,NE,68.0,F,"Pt. was admitted to hospital on 1/6/21 with fatigue, weakness. Pt. was Covid positive in November of 2020. Impression upon admission was fatigue may be due to her aortic stenosis and some hypertensive issues with blood pressure changes. She was anemic. WBC was elevated to 19.2, HBG 10.5, NA-131, K+ - 3.1, Rule out bacterial infection. Potential source could be her heart valve. Also noted to have acute renal failure with BUN of 47 and Creatinine of 2.2 noted. Pt. was transferred to Hospital on 1/8/2021 with dx of aortic stenosis, bacteremia, ARF, Dehydration and anemia. Discharged with dx. of sepsis. Pt. expired on 1/18/21 with dx. of severe sepsis, complete heart block, staphylococcus epidermidis bacteremia.",Yes,01/18/2021,Not Reported,Yes,13.0,Not Reported,N,12/24/2020,01/06/2021,13.0,PVT,"Bystolic - started on 12/21/20, Crestor started on 11/09/2020, Qzemoic subq weekly, Advair diskus, Fish oil, ASA, Vitamin E, Multivitamin",Denied any illness at time of the vaccination. November 2020 was diagnosed with Covid-19. Admitted to Hospital on 01/6/2021 with c/o weakness. Reported that her weakness was over her entire body. Reports having episodes of vomiting once or twice a week.,"Erysipelas, Aphthous pharyngitis, Sixth nerve palsy, Heart mumur, Acute renal insufficiency, Hypertension, Diabetes Mellitus",,NKA to medications,"['Acute kidney injury', 'Anaemia', 'Aortic stenosis', 'Asthenia', 'Atelectasis', 'Atrioventricular block complete', 'Blood creatinine increased', 'Blood potassium decreased', 'Blood pressure fluctuation', 'Blood sodium decreased', 'Blood urea increased', 'C-reactive protein increased', 'Cardiomegaly', 'Chest X-ray abnormal', 'Condition aggravated', 'Death', 'Dehydration', 'Fatigue', 'Haemoglobin decreased', 'Hypertension', 'Lung infiltration', 'Procalcitonin increased', 'Sepsis', 'Staphylococcal bacteraemia', 'Vomiting', 'White blood cell count increased']",1,MODERNA,IM 983432,IL,48.0,F,"I received a phone call from the persons work place. They reported that she had a seizure at 2:00 PM this afternoon. Prior to the seizure they said that she was ""feeling off"", ""jittery"", and ""misfiring"". The RN that notified me said that they were checking on her every hour and the last check in was at 1:00 PM. She went to check on her at 2:00 PM when she found her in the hallway very pale/gray, bradycardic, and hypotensive. The nurse said she appeared to be postictal and hallucinating. They immediately called 911 -and she was transferred to the hospital and to my knowledge she is still there. RN will keep me updated.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/27/2021,01/28/2021,1.0,PUB,unknown,unknown,unknown,,unknown,"['Bradycardia', 'Feeling abnormal', 'Feeling jittery', 'Hallucination', 'Hypotension', 'Pallor', 'Postictal state', 'Seizure']",2,MODERNA,IM 983553,MN,31.0,F,"After vaccination, patient complaining of chest pain / pressure, and sense of impending doom.Medication administered per EMS EPI given x2 at 0956 and 1015 ASA 325 chewable given at 1004 for c/o crushing chest pain. Emergency response provider arrived present. Pt started with c/o epigastric and then crushing CP. Pt appeared to be unresponsive at 1020 but the several minutes later she is arousable and anxious, breathing labored and she is stating she is ""going to die"". Transported to ED where delirium was noted and due to elevated ammonia level current presumptive diagnosis is hepatic encephalopathy.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/28/2021,01/28/2021,0.0,WRK,"ferrous sulfate 325 mg (65 mg iron) tablet levothyroxine (SYNTHROID, LEVOTHROID) 200 mcg tablet levothyroxine (SYNTHROID, LEVOTHROID) 75 mcg tablet metFORMIN XR (GLUCOPHAGE-XR) 500 mg 24 hr tablet omeprazole (PriLOSEC) 20 mg DR capsule onda",Liver failure on transplant list.,"S/P resected metastatic biliary neuro endocrine tumor, multiple pulmonary nodules, secondary malignant lung neoplasm, mediastinal lymphadenopathy, biliary cirrhosis, GERD, type 2 diabetes, hyperlipidemia, hypothyroidism, chronic granulomatosis disease, and anemia.",,Ketamine (N/V) and cat dander (itching),"['Abdominal pain upper', 'Ammonia increased', 'Anxiety', 'Chest discomfort', 'Chest pain', 'Delirium', 'Dyspnoea', 'Fear', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 983612,TX,54.0,F,"Following vaccination, at the 15 min mark, patient started experiencing tightening around throat and tingling around lips. Benadryl 25mg PO given w/ water. Pt monitored and taken to observation area where she needed further treatment. (refer to PE) PE: 1400- pt started 30 min motoring post vaccination. 1415- pt expressed tightening around throat and tingling. respirations unlabored, no stridor heard. no rash observed. Benadryl 25mg PO given. 1420- Pt became tearful and expressed feeling SOB in addition to symptoms. no angioedema or other symptoms observed. patient moved to monitor room where vitals were taken. 98%, 94HR, 192/115. CTAB 1423- pt distressed, 94%. unable to verbalize and making chocking sign. EPI PEN immediately administered 0.3mg IM in left vastus lateralis. Lung sounds diminished bilaterally. vitals taken. >>>(*EPI PEN Given in prefilled syringe IM ONCE. LOT 0GM071, Expiration OCT 21) 1424- 203/125, 105HR, 97%. pt sitting upright, tearful but now able to verbalize. 1425- pt sighed in relief, able to take a deep breath, stating ""ok. It passed."" Lungs CTAB. 98%, 91HR, 16RR. 1430-pt sitting calmly in chair. Breathing unlabored. Denies SOB. No distress at this time. 108/101, 14RR, 98% 1432-98%, 95HR. Patient able to tolerate clear PO fluids. NO n/v or abd pain. 1436-99%, 77HR, 159/85, RR 15-16. CTAB. 1440-unlabored respirations. CTAB. patient sitting comfortable in chair. no distress. 1443- 97%, 70 HR. 1450- Regular heart rate on auscultation. 1454-12RR, 98%, 102 HR, 164/83 1512-164/82, 97.4F, 91HR, 97%, 20RR. No distress. 1527-20RR, 175/83, 98%, 91HR, 96.4F. No distress. 1542-22RR, 155/81, 98%, 82, 96.9F. No distress. 1600- pt ambulates to restroom independently without any SOB, weakness or dizziness. 1615- Pt sitting comfortably in chair. 99%, 88HR, 148/85, 96.9F, 18RR. No distress. 1650-Pt denies blurred vision, HA, dizziness, weakness, chest pain, palpitations, SOB, tightening to throat, swelling, n/v or pruritis. no rash present. pt in no distress. 157/87, 96.7F, 99%, 88HR, 15RR. 1700-Pt no distress. pt d/c to family member.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,WRK,multivitamin,None.,DMT2,localized pruritis and sensation of tingling of lips on 1st dose of Moderna vaccine 1 mo prior. No angioedema. Pt received benad,"Augmentin, Flonase, Darvocet. Bee stings, shellfish.","['Breath sounds abnormal', 'Choking', 'Dyspnoea', 'Emotional distress', 'Paraesthesia oral', 'Pharyngeal paraesthesia', 'Tearfulness', 'Throat tightness']",2,MODERNA,IM 983647,TX,31.0,F,"Began experiencing fast heartbeat at approx 1730. Sought care at urgent care/ED. Heart rate continued to increase along with elevated blood pressure. Was treated with Benadryl, Epi, Zofran, and Ativan. Transferred to local hospital for observation and continued montioring.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,Levothyroxine Enskyce Nasonex Nasal Spray Allergy Antigen Injections for seasonal allergy control,none,hypothyroidism,,Seasonal Allergies,"['Blood pressure increased', 'Blood thyroid stimulating hormone normal', 'Chest X-ray normal', 'Echocardiogram normal', 'Heart rate increased', 'Laboratory test normal', 'Ultrasound scan normal']",UNK,MODERNA,IM 983664,,43.0,M,"Abdominal pain, diarrhea, syncope, bradycardia, fever",Not Reported,,Not Reported,Yes,,Not Reported,,01/27/2021,01/27/2021,0.0,UNK,,,,,,"['Abdominal pain', 'Bradycardia', 'Diarrhoea', 'Pyrexia', 'Syncope']",UNK,MODERNA, 983741,MO,43.0,F,"She received her first dose of Moderna COVID-19 vaccine at 7:30 AM on 1-22-21. At 9:15 AM, she felt lightheaded, her heart was racing, and vertigo. She had a nurse check her blood pressure and it was 101/65 and her heart rate was 138 bpm. She felt presyncopal so she went to the ED for evaluation. By the time she got to the ED, she felt her throat was scratchy, and when she would lie down flat she felt her throat was occluding. She notes that she is s/p tonsillectomy in 12-2020, and considered whether that was playing a role in her symptoms, but she had not had any of those throat symptoms for 1 week prior to getting her COVID-19 vaccine. In the ED, she was given IV medications and IV fluids. ENT was consulted. Her symptoms got better with medications, she is still experiencing some throat dryness but otherwise is feeling back to her usual self. She never had any rash, flushing, itching. She had a little tenderness at the injection site only. She never had any difficulty breathing, lip/eye/tongue swelling, wheezing, coughing, shortness of breath, vomiting/diarrhea/abdominal pain. She did have nausea when she felt vertigo.",Not Reported,,Yes,Not Reported,,Not Reported,U,01/22/2021,01/22/2021,0.0,UNK,,Completed tonsillectomy 12-28-20,"tonsil stone, rosacea, migraine, HPV, asthma",,"adhesive tape, sulfa","['Blood immunoglobulin E', 'Dizziness', 'Dry throat', 'Full blood count', 'Injection site pain', 'Metabolic function test', 'Nausea', 'Palpitations', 'Presyncope', 'Throat irritation', 'Throat tightness', 'Tryptase', 'Vertigo']",UNK,MODERNA, 983745,WA,85.0,M,"Pt. woke up on 1/13/21 throwing up, this continued throughout the day about 5 episodes total. Pt. had no appetite that day and drank or ate very little. During the night on 1/13/21, he woke up and when his caregiver tried to help him to the bathroom, he had weakness on the right side of his body. Caregiver called on 1/14/21 letting us know the pt. has increased weakness. Caregiver encouraged to take pt. to Er. Pt. refused. Pt. seen in clinic on 1/15/21 and examination found pt. to have right hemiparesis including foot drip, right arm weakness, loss of motor control on the right upper and lower extremities. Facial droop on the right with disarticulation of speech and control of the tongue.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/11/2021,01/13/2021,2.0,PVT,"Multivitamins, Aspirin, Risperidone, Insulin Glargine",,"Diabetes, Dementia, renal failure and history of cerebrovascular accident.",,,"['Decreased appetite', 'Facial paralysis', 'Hemiparesis', 'Motor dysfunction', 'Muscular weakness', 'Peroneal nerve palsy', 'Speech disorder', 'Tongue movement disturbance', 'Vomiting']",1,MODERNA,IM 983766,NC,90.0,F,Pt started complaining of chest heaviness and shortness of breath on the afternoon of 1/21/21. EMS was called to the patients home and she was found to have an O2 sat in the 70's. She was admitted to hospital and found to have a proBNP of 5000. She tested negative for Covid-19. She was determined to be in acute-on-chronic heart failure and was referred for hospice care. She passed away on the evening of 1/24/21.,Yes,01/24/2021,Not Reported,Yes,3.0,Not Reported,N,01/16/2021,01/21/2021,5.0,PVT,"Furosemide 20mg 2poBID, Warfarin 5mgQD, Omeprazole 20mg BID, Propanolol 10mg BID, atorvastatin 40mg QD, vitamin D 1000IUQD","Heart failure with reduced EF, history of moderate pulmonary hypertension, history of moderate mitral valve regurgitation and moderate pulmonary valve regurgitation. History of A. fib.","Heart failure with reduced EF, history of moderate pulmonary hypertension, history of moderate mitral valve regurgitation and moderate pulmonary valve regurgitation. History of A.fib.",,No known allergies to drugs or food,"['Blood pH decreased', 'Cardiac failure acute', 'Chest discomfort', 'Death', 'Dyspnoea', 'International normalised ratio increased', 'N-terminal prohormone brain natriuretic peptide increased', 'SARS-CoV-2 test negative']",1,MODERNA,IM 983842,AR,67.0,M,"PATIENT EXPERIENCED ISSUES WITH SOME LIP SWELLING AND PRESENTED TO THE PHARMACY ON FRIDAY JANUARY 19TH IN THE MORNING. HE HAD VISIBLE SWELLING ON ONE SIDE OF BOTH LIPS . HE PURCHASED SOME DIPHENYDRAMING 25MG OTC AND LEFT. ACCORDING TO HIS WIFE VIA PHONE TO US (ON JAN 26 6PM) HE HAD BEEN ADMITTED TO THE ER AND WAS ON A VENTILATOR DUE TO SEVERE SWELLING OF HIS LIPS, NECK AND TONGUE. HIS AIRWAY HAD BECOME COMPROMISED AND HE WAS STARTING TO EXPERIENCE NAUSEA AND VOMITING. HE WAS IMMEDIATELY INTUBATED AND PLACED ON A VENTILATOR EVEN THOUGH HE WAS STILL CAPABLE OF BREATHING ON HIS OWN. DRS WERE FEARFUL OF MORE SWELLING AND WANTED TO SEDATE HIM AND BEGIN TREATMENTS.",Not Reported,,Yes,Yes,3.0,Not Reported,N,01/18/2021,01/21/2021,3.0,PHM,"LISINOPRIL 2.5MG, METFORMIN 500MG ER, CITALOPRAM 20MG, B-12 INJECTION, EZETIMIBE 10MG, GLIPIZIDE 10MG, METOPROLOL 25MG, PANTOPRAZOLE 40MG, PRASUGREL 10MG, ROSUVASTATIN 20MG,",COMPLAINT OF SINUS ISSUES AND NON PRODUCTIVE COUGH,HEART CONDITION,,"SULFONYLUREAS,","['Endotracheal intubation', 'Lip swelling', 'Mechanical ventilation', 'Nausea', 'Obstructive airways disorder', 'Sedative therapy', 'Swelling', 'Swollen tongue', 'Vomiting']",1,MODERNA,IM 983883,AZ,50.0,F,"Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache that would not be relieved with tylenol. I took a plane and arrived at 1130 pm. I went to bed shortly after arriving at my daughters house. Friday morning, I was unable to be woken up and my daughter called 911. I was in a coma. I suffered cardiac arrest during a CT to check for clots. I was resuscitated and put on life support. CT scan for clots, strokes, heart attacks were all clear. I was admitted to the C-ICU and on life support, on the ventilator, and was on 3 different medications at max dosage to keep my blood pressure barely surviving. The doctors told my daughter not to expect me to survive because they had no idea why I was suddenly so ill. A doctor then told my daughter that my kidneys were failing, and my liver was damaged. I also developed a high fever and had a high white blood cell count. They gave me Vancomycin and another antibiotic, and then the next the day a kidney doctor gave me lasix to flush out all of the excess fluid. I woke up on Saturday not knowing what had happened and was completely terrified and confused. My daughter was allowed into the ICU to see me and keep me calm, thankfully. She explained to me what happened. I am still in the hospital, as they are keeping me for observation and trying to determine if my kidneys will start working properly again. Prior to this, I have only ever had a kidney infection, and I thought before I might have had the start of a UTI. I do have chronic high blood pressure as well, a long term side effect from open heart surgery 10 years prior for an aneurysm, but aside from that I am relatively healthy 50 year old.",Not Reported,,Yes,Not Reported,,Yes,U,01/20/2021,01/28/2021,8.0,PVT,"Metoprolol, procardia, asirin, suboxone, locartin,","chronic high BP, possible uti",high blood pressure,,"codiene, demerol, milk","['Cardiac arrest', 'Coma', 'Computerised tomogram thorax normal', 'Confusional state', 'Dependence on respirator', 'Fatigue', 'Fear', 'Headache', 'Intensive care', 'Life support', 'Liver injury', 'Pyrexia', 'Renal failure', 'Resuscitation', 'Unresponsive to stimuli', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 983919,FL,69.0,M,death,Yes,,Not Reported,Not Reported,,Not Reported,,01/21/2021,01/01/2021,,PHM,,,,,,['Death'],1,MODERNA,IM 983933,NY,97.0,F,"Already reported immediate severe weakness, lethargy, withdrawal, delirium. Now adding 4 days later ... hypotension, nausea, vomiting, diarrhea, cramps, chest pain. ER visit and 2 day hospitalization. Abdominal CT indicated intestinal inflammation in the area of the Cecum. One week of antibiotics.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/12/2021,01/16/2021,4.0,PHM,"Simvastatin, Eliquis, Budesonide, Calcium, Vitamin D, Duloxetine, Bupriopion, Metoprolol Succinate, Lasix, Pepcid.",,"CHF, AFib.",,,"['Asthenia', 'Blood test', 'Chest pain', 'Computerised tomogram abdomen abnormal', 'Delirium', 'Diarrhoea', 'Gastrointestinal inflammation', 'Hypotension', 'Lethargy', 'Muscle spasms', 'Nausea', 'Vomiting', 'Withdrawal syndrome']",1,PFIZER\BIONTECH,IM 983960,OR,56.0,F,On 1/12 -1/15 worst migraine and left eye pain of my life. Saw retinal specialist 1/15. On 1/15 saw my PCC provider. Woke up 1/17 with blurry vision and continued eye pain. Talked to my Rheumatologist 1/19. I saw my PCC in person 1/20. Got sent to ER got admitted. Had an MRI and a lumbar puncture. I was diagnosed with optic neuritis by the neurologist. I continued to do 5 days of out pt iv steroids.,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/11/2021,01/12/2021,1.0,PVT,Plaquenil Zyrtec Synthroid Ambien Pilocarpine Vitamin D Vitamin C,,Rheumatoid Arthritis HX Migraines Hashimoto?s,,Latex,"['Blood test', 'Condition aggravated', 'Eye pain', 'Lumbar puncture', 'Magnetic resonance imaging', 'Migraine', 'Optic neuritis', 'Vision blurred']",2,PFIZER\BIONTECH,IM 985015,AK,89.0,F,There were no signs of adverse affects from vaccine. She was admitted to hospital due to stroke.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/13/2021,01/15/2021,2.0,OTH,Aspirin; Calcium w/vit D; Cholecalciferol; Cinnamon; Flaxseed Oil; Fluoxetine HCl; Levothyroxine Sodium; Lidocaine-Prilocaine Cream Lisinopril; Metoprolol Succinate ER; Multivitamin with Minerals; Omeprazole; Tolterodine Tartrate ER; Ibupro,UTI,"Weakness; Hypo-osmolality and Hyponatremia; Essential (Primary) Hypertension; Disorientation, unspecified; Unspecified Urinary Incontinence; Type 2 Diabetes Mellitus with Diabetic Neuropathy, unspecified; Hypothyroidism, unspecified; Urinary Tract Infection, site not specified",,No known allergies,['Cerebrovascular accident'],1,MODERNA,IM 984400,,39.0,U,"arm soreness; headache; fatigue; mild body aches; The initial case was missing the following minimum criteria: Unidentifiable reporter. Upon receipt of follow-up information on 17Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient) and another contactable consumer. A 39-year-old patient of an unspecified gender received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 14Dec2020 at single dose for covid vaccine. The patient's medical history and concomitant medications were not reported. The patient was almost 72hrs in and feel normal. The patient had arm soreness the first day (14Dec2020) followed by headache, fatigue, and mild body aches lasting about 36hrs. The patient was vaccinated in the middle of six emergency room shifts in 7 days so the patient suspected that contributed to some of the fatigue. The patient was able to go for a run yesterday (unspecified date) before night shift and felt fine during shift. So all in all, the side effects for the patient had been mild without needing any Motrin or Tylenol. The outcome of events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/14/2020,12/14/2020,0.0,UNK,,,,,,"['Fatigue', 'Headache', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 984401,FL,70.0,M,"when he pushes on the injection site, he does feel a little pain; feel a little tightness in his breathing/ tightness/shortness of breath; on his finger (pulse ox) showing he had 95% oxygen uptake, looked like 91% and then it went up to 93%; feel a little bit of heat on his forehead; nose dripping/nose was running; seems like it isn't working; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL1283, via an unspecified route of administration on 13Jan2021 09:55 at a single dose on the Upper Left Arm, probably on muscle near the top for COVID-19 immunization. Medical history included shellfish allergy, asthma, hay fever, reaction/allergy to oleander plant (rash on his legs) and had surgery on his hip. There were no concomitant medications. The caller received Pfizer's COVID-19 vaccine early yesterday morning, 13Jan2021 and his second dose has been scheduled for more than 3 weeks. He also mentioned that his vaccine ""seems like it isn't working"". The patient stated it doesn't look like he had much of a response. All of his neighbor's arms are so sore and 'blah blah' and they have other side effects. He feels like everybody else had a much bigger reaction. He read there was a whole bunch of people that was given the COVID-19 vaccine with a short needle and all of their vaccinations had to be re-done. He really didn't feel nothing when he was being injection. He explained that when he pushes on the injection site, he does feel a little pain on 14Jan2021. However, he was heavily muscled in that area, and also based on his recent surgery on his hip and other experiences, he noticed on the surgeons files on his case, it says he has a high tolerance for pain which he believes to be true. He believes he may have been injected with a short needle. He was just wondering what size of needle is supposed to be used for the Pfizer vaccine and asked how he can find out what needle was used on him. He doesn't know if this was an intramuscular injection, but he assumes they were trying to get into the muscle. The patient stated he does have allergies, particularly to shellfish, but they haven't been really acting up a lot or that much. He told them about his allergies when he was receiving the COVID-19 vaccine, and they kept him for half an hour after receiving it on 13Jan2021. He did feel a little tightness in his breathing. He does have a little bit of asthma and he does have hay fever and all of that stuff. They put the little thing on his finger (pulse ox) showing he had 95% oxygen uptake, which is little low for him. The next time that checked it first looked like 91% and then it went up to 93%, but the way one holds their finger has something to do with that. He waited a few more minutes and assumed it was probably just allergies. He felt how it feels when he gets into pollen. He took a couple of puffs of his inhaler (Pro air HFA (albuterol sulfate) and the tightness very quickly went back to normal. The last reading when they put the pulse ox on his finger was 96.5. It should be 98 but at that point he talked to them and was feeling much better. He also mentioned he did feel a little bit of heat on his forehead last night (13Jan2021), he might have noticed it. However, the breathing stuff (Tightness/shortness of breath) started again. He used his inhaler again which would have been about 9 hours later, and he also took a Claritin as well. He doesn't normally take Claritin but he does take it every day up north and the last few weeks he did have his Condo wide open. The patient confirmed the tightness/shortness of breath wasn't immediately after receiving the COVID-19 vaccine, it was about 15-20 minutes after. The feeling felt no different than when he starts having a reaction to cigar smoke or something like that. The tightness/ shortness of breath improved immediately after using his inhaler. He used the inhaler which cleared up the tightness instantly as it always does but his nose was running kind of like when one has the flu. He clarifies he noticed late afternoon/evening; his nose was dripping. The dripping went on for 2-3 hours. He knew the inhaler wouldn't necessarily stop the dripping, so he figured he better take a Claritin. He stated not too longer after taking the Claritin, maybe 15-20 minutes afterwards when the Claritin started taking effect, the dripping stopped, and it hasn't been back since. He believes he took one Claritin a day before. The outcome of the event nose dripping was recovered, tightness/shortness of breath and 'on his finger (pulse ox) showing he had 95% oxygen uptake, looked like 91% and then it went up to 93%' was recovering, 'when he pushes on the injection site, he does feel a little pain' was not recovered while for other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/13/2021,0.0,PUB,,,Medical History/Concurrent Conditions: Allergy to plants; Asthma (Verbatim: Asthma); Hay fever (Verbatim: Hay fever); Hip surgery; Shellfish allergy (Verbatim: Shellfish allergy),,,"['Asthma', 'Chest discomfort', 'Dyspnoea', 'Injection site pain', 'Rhinorrhoea', 'Skin warm']",1,PFIZER\BIONTECH, 984402,AK,63.0,U,"pulse 128, heart is still beating too fast; took my blood pressure and it was high for me. 167/102/high blood pressure; patient was very tired; I was lightheaded and saw spots before my eyes; My heart pounded in my chest; my pulse erratic; low potassium; high sugar; high thyroid; low sodium; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (vaccination location: left arm) on 04Jan2021 at 12:00 at SINGLE DOSE for COVID-19 immunisation. Medical history included allergies to latex from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient previously took tetracycline and experienced allergies to tetracycline. It was reported that the evening of the vaccine, the patient was very tired. Patient stated, ""I took my blood pressure and it was high for me. 167/102, pulse 128, I was lightheaded and saw spots before my eyes"". The patient called the nurse hotline and was sent to the ER. The ER just said that the patient had high blood pressure which patient stated, ""I don't, I take it regularly"". The patient also stated, I was off work for a week, too tired to get off the couch. My heart pounded in my chest, my pulse erratic. I went to the doctor 2 days later. She said it was from the vaccine. My labs from the ER showed low sodium, low potassium, high sugar and high thyroid. I had no health issues before the vaccine. I am back at work, but my heart is still beating too fast. This morning while doing nothing it was 102"". No treatment was provided for the events. Covid test post vaccination (test type: nasal swab) on 07Jan2021 was negative. Outcome of the events was reported as recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PHM,,,Medical History/Concurrent Conditions: Latex allergy,,,"['Blood potassium decreased', 'Blood sodium decreased', 'Dizziness', 'Fatigue', 'Heart rate increased', 'Heart rate irregular', 'Hypertension', 'Palpitations', 'SARS-CoV-2 test negative', 'Thyroid function test abnormal', 'Vitreous floaters']",1,PFIZER\BIONTECH, 984404,IL,41.0,F,"Full body rash; trouble clearing throat; felt like there was something stuck in throat; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3249), intramuscular (right arm), on 13Jan2021 09:45, at single dose, for covid-19 immunization. Medical history included allergies: sea salt, hypothyroidism, anemia, asthma, and seizures (when younger). Concomitant medications were not reported. The patient previously took tramadol and hydrocodone and experienced allergies to both drugs. The patient experienced full body rash on 13Jan2021 10:15 (also reported as about 30 mins after vaccination). On 13Jan2021 10:15 (also reported as about an hour after receiving vaccination), the patient had trouble clearing throat and felt like there was something stuck in throat. The patient has been taking Benadryl and Motrin for these adverse events. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination and, had not been Covid-tested post vaccination. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/13/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Anemia; Asthma; Food allergy; Hypothyroidism; Seizures (Seizures when younger),,,"['Adverse event', 'Rash', 'Sensation of foreign body', 'Throat clearing']",UNK,PFIZER\BIONTECH,OT 984405,NY,,F,"tested positive for Covid-19; asymptomatic; tested positive for Covid-19; asymptomatic; Back pain; Cold; This is a spontaneous report from a contactable nurse (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 29Dec2020 at single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient informed that she received the first dose of the Covid-19 vaccine on 29Dec2020 and her second dose was scheduled on 19Jan2021, but she was tested positive for Covid-19 on unspecified date. The patient informed that she was asymptomatic and only has back pain and cold. The patient wanted to know if she can receive the second dose of the vaccine. The outcome of the events tested positive for Covid-19; asymptomatic, back pain, cold was unknown. Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Based on the time association, the lack of efficacy cannot be excluded for vaccine BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,,,UNK,,,,,,"['Asymptomatic COVID-19', 'Back pain', 'Nasopharyngitis', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 984406,AR,36.0,M,"test for COVID-19/Positive; test for COVID-19/Positive; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received the first dose of BNT162b2 (Lot number: EL1284), via an unspecified route of administration in left arm on 22Dec2020 17:00 at single dose for covid-19 immunization. Medical history included High Cholesterol. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. The patient received the Rapid throat swab test for COVID-19 on 30Dec2020, the result was positive. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/30/2020,8.0,UNK,,,Medical History/Concurrent Conditions: High cholesterol,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 984408,,,F,"Vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 05Jan2021 at 05:00 at a single dose for COVID-19 immunization. Medical history included skin auto-immune disease and auto-immune hypothyroidism. The patient's concomitant medications were not reported. The patient received the vaccine on 05Jan2021 at 05:00. The next day at 6:30 AM (06Jan2021), the patient started having vaginal bleeding that has not subsided yet and still going strong. The patient had seen a lot of specialist. She went to the ER twice and had CT scan, 3 biopsies taken, internal sonogram, had blood tests and urinalysis done, all with unknown results. The doctor told her if it doesn't stop in a couple of weeks, the patient will undergo a general anesthesia to further analyze the situation. The physician did not have information on vaccination for people with auto-immune issue. The patient had not yet recovered from the event vaginal bleeding. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Autoimmune disorder; Autoimmune hypothyroidism,,,"['Biopsy', 'Blood test', 'Computerised tomogram', 'Ultrasound scan vagina', 'Urine analysis', 'Vaginal haemorrhage']",UNK,PFIZER\BIONTECH, 984409,IL,22.0,F,"She has abdominal cramping now; Chills; she develops joint pain /They were sore and stiff; she develops joint pain /They were sore and stiff; This is a spontaneous report from a contactable consumer patient via a Pfizer-sponsored program. A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685, Lot Expire Date: unknown), intramuscular injection in left deltoid on 30Dec2020 07:15 AM at single dose for COVID-19 immunization (reported as ""Why was the patient taking COVID19 Vaccine (Verbatim): healthcare worker ""). Medical history included ongoing allergy to sulfa antibiotics since 1998 (diagnosed within her first year of life) and allergic to the cold from 2011 and ongoing. She has an allergy to the cold and people sometimes confuse it with Raynaud's. It is not Raynaud's. Concomitant medication included etonogestrel (NEXPLANON) from May2019 and ongoing for birth control. The patient received the vaccine on 30Dec2020 and developed symptoms 4 days ago (10Jan2021), she was experiencing joint pain and chills, also reported as ""just over the last 2 days she develops joint pain and chills"". Patient experienced chills on 13Jan2021. Patient just called about possible side effects and she was wondering if she should get the second dose. Her side effects were minor. They were joint pain and chills. Joint Pain started in the hips and felt like something was wrong. They were sore and stiff. She has abdominal cramping now and she was not sure if that is from the joint pain or regular period. She just finished her menstrual cycle and normally she has cramps afterwards. She does not have a fever. Patient has checked her temperature three times. 30Dec2020 was when she received her first dose. Vaccination Facility Type was health center . The events did not require a visit to emergency room and physician office. No prior vaccination within 4 weeks but patient reported that events following prior vaccinations was ""the worst was swelling and tenderness with HPV vaccine. HPV vaccine manufacturer: unknown"". Outcome of the event chills was not recovered (ongoing) while for other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/10/2021,11.0,SCH,NEXPLANON,Environmental allergy; Sulfonamide allergy (diagnosed within her first year of life),,,,"['Abdominal pain', 'Arthralgia', 'Chills']",1,PFIZER\BIONTECH,OT 984410,CT,47.0,F,"she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so now they are telling her to go this weekend; she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so now they are telling her to go this weekend; tested positive for COVID; tested positive for COVID; not feeling very well; feeling dizzy and weak; feeling dizzy and weak; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiration date not provided), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included Diabetes which was diagnosed in Apr2020. There were no concomitant medications. The patient received the first dose of the vaccine on 22Dec2020. She tested positive for COVID19 on 08Jan2021. The second dose of vaccine on 12Jan2021 was deferred as the patient was not feeling well on an unspecified date in Jan2021. She asked for guidance/information about receiving the second dose after testing positive. She stated that she was still feeling dizzy and weak on an unspecified date in Jan2021. She said that she heard the people were not feeling too well after the second dose and she will get it as long as it will not kill her. She asked what will happen if she does not take the second dose and will she need to get the series again. She wanted to know if she can take the second dose of vaccine. She clarified that she was supposed to get her second dose on 12Jan2021 but she was not feeling very well so now they were telling her to go on the weekend. She does not feel fine. She asked if it was safe for her to take the second dose or should she wait. She wanted to know if the effect of the first dose is null since she has now delayed it so long. She is the supervisor of ultrasound department. She started having COVID symptoms of 04Jan2021, she was tested on 05Jan2021 and got a positive result on 08Jan2021. The outcome of the events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive for COVID19 based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,01/01/2021,10.0,UNK,,,Medical History/Concurrent Conditions: Diabetes,,,"['Asthenia', 'Dizziness', 'Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 984411,,,U,"significant leakage from the site of injection; This is a spontaneous report from contactable pharmacist. This pharmacist reported similar events for two (2) patients. This is the first of the two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After administration of the vaccine, two of the doctors had significant leakage from the site of injection. This was a clear fluid leaking out of the site of injection. The pharmacist stated this type of leaking fluid is a common occurrence with the flu vaccine and asked if there is any particular guidance on what should be done in the case of this vaccine. Should the doctors get titers drawn up to determine if they need to get a 3rd dose? Should they go ahead and get the 3rd dose anyways? Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021042161 same drug/event, different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Injection site extravasation'],UNK,PFIZER\BIONTECH, 984412,NY,31.0,F,"numbness to my left leg (from my ankle to my hip/waist)/ right side also became slightly numb/numbness to her left arm; My left knee was buckling, making walking very difficult; My left knee was buckling, making walking very difficult; my right side also became slightly numb, and was also tingling; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ELO140, expiration date unknown), via an unspecified route of administration in the left arm on 10Jan2021 at 11:45 AM at a single dose for COVID-19 immunization. Medical history included neuropathy and migraine. The patient did not have COVID prior to vaccination. Patient is not pregnant. Concomitant medications included cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), colecalciferol (VITAMIN D [COLECALCIFEROL]) and acacia senegal, ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium silicate, cellulose microcrystalline, colecalciferol, croscarmellose sodium, cyanocobalamin, dextrin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, gelatin, glucose, hypromellose, lecithin, macrogol, magnesium oxide, magnesium stearate, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, starch, thiamine mononitrate, titanium dioxide, zinc oxide (ONE-A-DAY WOMEN'S) on unspecified dates for unspecified indications. The patient has not had other vaccines in four weeks. On 10Jan2021, three hours after being vaccinated (at approximately 3:00 PM), the patient experienced complete numbness to her left leg (from her ankle to her hip/waist). Hours later, the patient noted numbness to her left arm. Her left knee was buckling, making walking very difficult. The patient reported to the ER, and after several hours of waiting to be seen by a doctor, her right side also became slightly numb, and was also tingling. 18 hours after symptom onset (at approximately 9:30am, the day following injection), the numbness on her right side resolved. It was also reported that the numbness on her left side did not completely resolve for more than 24 hours. The patient underwent lab tests and procedures which included nasal swab test which was negative on 13Jan2021 . Therapeutic measures were taken as a result of the events which included anti-anxiety medication for calming. The outcome of the events left knee was buckling, making walking very difficult and tingling was recovered on unspecified date, while the rest of the events was recovering at the time of report.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported complete numbness to her left leg (from her ankle to her hip/waist)/numbness to her left arm, left knee was buckling, walking very difficult, right side also became slightly numb and tingling, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/10/2021,0.0,SEN,VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D [COLECALCIFEROL]; ONE-A-DAY WOMEN'S,,Medical History/Concurrent Conditions: Migraine; Neuropathy,,,"['Gait disturbance', 'Hypoaesthesia', 'Joint instability', 'Muscular weakness', 'Paraesthesia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 984413,CA,49.0,F,"BP 218/116; headache; cold sweats; shivering; This is a spontaneous report from a contactable nurse (patient) reported that a 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKS730), via an unspecified route of administration on the right arm on 20Dec2020 11:15 at a single dose for Covid-19 immunization. Medical history included allergic rhinitis and atopic dermatitis both from an unspecified date. Patient is not pregnant. Concomitant medications included montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), doxycycline, prednisone, and diphenhydramine hydrochloride (BENADRYL); all were taken from an unspecified date for an unspecified indication. The patient received the second dose of other vaccine (unspecified, Pfizer product, lot number: EK9231), via an unspecified route of administration on the right arm on 14Jan2021. On 20Dec2020 11:45, the patient had headache, cold sweats, shivering, and BP (blood pressure) 218/116. The patient called Rapid Response Nurse, and she was wheeled to the hospital E.R. The patient was seen by a doctor and opted to just monitor her BP, no medication or IV line started. The patient was discharged with SBP of 159. The outcome of the event BP (blood pressure) 218/116 was recovering while the rest of the events was unknown.; Sender's Comments: The subject received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 11:15. On 20Dec2020 11:45, the patient had blood pressure high, 218/116 mmHg. Based on information available, the reported high blood pressure was probably causally related to the first dose of BNT162B2, considering the plausible temporal relationship, and clinical course. However, the concomitant medications, especially prednisone, for unspecified indications, could be confounding factors. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/20/2020,0.0,PVT,SINGULAIR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; DOXYCYCLINE; PREDNISONE; BENADRYL,,Medical History/Concurrent Conditions: Allergic rhinitis; Atopic dermatitis,,,"['Chills', 'Cold sweat', 'Headache', 'Hypertension']",1,PFIZER\BIONTECH, 984414,OK,40.0,F,"Facial numbness and tingling; Facial numbness and tingling; This is a spontaneous report from a contactable other healthcare professional (HCP). A 40-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on the right arm on 08Jan2021 at 07:15 at a single dose for COVID-19 immunization. Medical history included anemia, Vitamin D deficiency, and known allergies to dairy and kiwi. Concomitant medication included iron (IRON), colecalciferol (VITAMIN D [COLECALCIFEROL]), zinc (ZINC), linum usitatissimum oil (FLAXSEED OIL [LINUM USITATISSIMUM OIL]), and cetirizine (CETIRIZINE). The patient had no other vaccine in four weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH9899, on the right arm on 19Dec2020 at 0745AM for COVID-19 immunization. The patient had no COVID prior vaccination and had not tested for COVID post vaccination. The patient experienced facial numbness and tingling on 08Jan2021 at 08:15. No treatment was administered for the events. The events resolved on an unknown date in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,IRON; VITAMIN D [COLECALCIFEROL]; ZINC; FLAXSEED OIL [LINUM USITATISSIMUM OIL]; CETIRIZINE,,Medical History/Concurrent Conditions: Anemia; Dairy intolerance; Food allergy; Vitamin D deficiency,,,"['Hypoaesthesia', 'Paraesthesia']",2,PFIZER\BIONTECH, 984415,HI,40.0,F,"on left arm, almost immediately after left hand became increasingly cold; This is a spontaneous report from a non-contactable Other-HCP reporting for herself. A 40-years-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration on arm left from 14Jan2021 07:00 to 14Jan2021 07:00 at SINGLE DOSE for covid-19 immunisation. Medical history included Prolonged QT syndrome. The patient's concomitant medications were not reported. The patient had her first dose of BNT162B2 on 23Dec2020 to 23Dec2020. On 15Jan2021 at 07:00, on left arm, almost immediately after left had became increasingly cold. Right had was ok and did not change in temperature. Area around the shot was not cold, only hand. Coldness lasted for about 15 minutes before slowly getting back to normal temperature. The patient had not received any treatment for the event. The patient was not pregnant at the time of the report. Outcome of the event was recovered on an unspecified date. No follow up attempts are possible, information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/15/2021,1.0,PVT,,,Medical History/Concurrent Conditions: QT prolonged,,,"['Immediate post-injection reaction', 'Peripheral coldness']",2,PFIZER\BIONTECH, 984416,,32.0,F,"Severe generalized pruritus, likely delayed hypersensitivity; Severe generalized pruritus, likely delayed hypersensitivity; This is a spontaneous report from a contactable physician (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 10Jan2021 at 08:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included seasonal allergies. Patient has no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 12Jan2021, the patient experienced severe generalized pruritus, likely delayed hypersensitivity. Patient was given antihistamines and topical agents for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/12/2021,2.0,PVT,,,Medical History/Concurrent Conditions: Seasonal allergy,,,"['Pruritus', 'Type IV hypersensitivity reaction']",2,PFIZER\BIONTECH, 984417,FL,75.0,F,"Very painful stiff neck; Very painful stiff neck; rapid heartbeat; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 11Jan2021 13:15 at single dose (left arm) for COVID-19 immunization. The patient had no medical history. The patient had no known allergies and patient was not pregnant. Concomitant medication included gabapentin, diltiazem hydrochloride (DILT-XR), losartan and ezetimibe (ZETIA). On 14Jan2021 at 22:00, the patient experienced very painful stiff neck and rapid heartbeat. The patient had no therapy for the events. The patient had no other vaccine in 4 weeks, and did not have Covid prior vaccination. The patient was no Covid tested post vaccination. Outcome of events was not recovered. Information on Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/14/2021,3.0,UNK,GABAPENTIN; DILT-XR; LOSARTAN; ZETIA,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Heart rate increased', 'Musculoskeletal stiffness', 'Neck pain']",1,PFIZER\BIONTECH, 984418,NC,25.0,M,"Muscle tightness; soreness at the injection site; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 14Jan2021 13:15 at single dose for Covid-19 immunization. The patient's medical history included Penicillin allergy (reported ""known allergies: Penicillin"". Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 (20:00), the patient experienced muscle tightness and soreness at the injection site up to 24 hours post injection. There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Injection site pain', 'Muscle tightness']",1,PFIZER\BIONTECH, 984419,ME,29.0,F,"red circle around the injecting site; injecting site, itchy; injecting site; a hard ball underneath; This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number El3246 and expiry date unknown) via unspecified route of administration at the left arm on 13Jan2021 09:15 at single dose for Covid-19 immunization in a hospital. Medical history included liver tumors, and allergies to ""sulfer"", thyroid (disorder), anxiety and blood pressure (abnormal). Concomitant medications included thyroid, anxiety and blood pressure medications. The patient has no other vaccine in four weeks. On 14Jan2021, the patient experienced red circle around the injecting site, itchy and a hard ball underneath. The patient did not receive treatment due to the events. The outcome of the events red circle around the injecting site, itchy and a hard ball underneath was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Anxiety; Blood pressure abnormal; Liver tumor; Sulfonamide allergy; Thyroid disorder,,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus']",1,PFIZER\BIONTECH, 984420,LA,53.0,F,"Fever; body ache; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL0142, unknown expiration), intramuscular in right arm on 13Jan2021 at 07:15 AM at a single dose for COVID-19 immunization in a hospital. Medical history included diabetes and high cholesterol. The patient's concomitant medication included unspecified vitamins. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, unknown expiration) via intramuscular in left arm on 23Dec2020 at 07:15 AM in a hospital. The patient also had known allergies to codeine. The patient experienced fever and body aches on 13Jan2021 at 13:00. The patient did not receive other vaccines in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not received treatment for the events. The patient had not yet recovered from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/13/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Diabetes; High cholesterol,,,"['Pain', 'Pyrexia']",2,PFIZER\BIONTECH,OT 984421,CT,,M,"coughed up what looked like blood in his spit; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received his first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at a single dose on 14Jan2021 for COVID-19 immunization, and apixaban (ELIQUIS) via an unspecified route of administration at an unspecified dose from an unspecified date as blood thinner. The patient's medical history and concomitant medications were not reported. The patient received his first shot of vaccine in the morning 14Jan2021 while on apixaban. After going to sleep at night, he woke up a couple hours later and coughed up some spit that looked like it had blood. It was 6 or 7 times. He stated he was ""ok now"" and it was just last night that one time. The action taken for apixaban was unknown. The outcome of the event was resolved on a unspecified date in Jan2021. He will have his second shot in 4 weeks and he is asking if he should get the second shot and if he should stop taking apixaban before his second shot. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,UNK,,,,,,['Haemoptysis'],UNK,UNKNOWN MANUFACTURER, 984422,FL,32.0,M,"101.8F fever; chills; nausea; headache; sinus pain; This is a spontaneous report from a contactable healthcare professional. A 32-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246) on his left arm, via an unspecified route of administration on 14Jan2021 08:45 at a single dose for COVID-19 immunization. Medical history included allergies to sulfa drugs. Concomitant medication included loratadine (CLARITINE) and crisaborole (EUCRISA). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 (first dose). The patient experienced 101.8F fever, chills, nausea, headache, sinus pain; all on 14Jan2021 11:00pm. No treatment was received for the events. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,PUB,CLARITINE; EUCRISA,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,"['Chills', 'Headache', 'Nausea', 'Pyrexia', 'Sinus pain']",2,PFIZER\BIONTECH, 984423,,,F,"experiencing diarrhea that is a little bit on the loose side; This is a spontaneous report from a non-contactable consumer (patient herself). A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 also known as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date not reported), via an unspecified route of administration on 13Jan2021 at single dose, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced diarrhea that she was a little bit on the loose side on an unspecified date in Jan2021. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/01/2021,,UNK,,,,,,['Diarrhoea'],1,PFIZER\BIONTECH, 984424,,,M,"Really dizzy; This is a spontaneous report from a contactable consumer (wife). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 15Jan2021 the patient experienced the event really dizzy. The reporter called to ask if dizziness was a side effect of the vaccine. The clinical outcome of the event, really dizzy, was unknown. The lot number for vaccine BNT162B2, was not provided and will be requested during follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/15/2021,1.0,UNK,,,,,,['Dizziness'],UNK,PFIZER\BIONTECH, 984425,PA,74.0,F,"both cheeks were very rosy red; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246) via an unspecified route of administration on 14Jan2021 (in the morning) at a single dose as COVID-vaccine, she got it as a protection to her because she's elderly with underlying conditions. Medical history was not reported. Concomitant medications included unspecified five prescriptions which she has been taking for a long time (nothing new). She has had no reaction to medications. Her diet was her normal diet. The patient experienced both cheeks were very rosy red on 14Jan2021 21:30. She wanted to know if experiencing very rosy red cheeks, on both sides, after receiving the Covid vaccine was a normal side effect. She received the first dose of the COVID Pfizer vaccine yesterday morning on 14Jan2021, everything was fine (good) at 7:30 p.m. Then at 9:30 p.m., while she was brushing her teeth, she noticed that both cheeks were very rosy red (her cheeks were rosy red). This morning, her cheeks appeared to be skin tone (skin looked normal). It was gone now; both cheeks were her normal skin tone and everything looked normal now. She didn't eat anything unusual the day of the vaccine. She was wondering if she should go back on 15Feb2021. She was going to ask her doctor and was going to notify her primary care doctor as well if she experiences any redness today or tomorrow. Investigation assessment was noted as no. The outcome of the event was recovered on 15Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,UNK,,,,,,['Erythema'],1,PFIZER\BIONTECH, 984426,FL,83.0,M,"bronchitis; Arm soreness; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: A3246/H3246, via an unspecified route of administration from 12Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included asthma and ongoing cough. There were no concomitant medications. The patient had a minor cough and was spitting up phlegm but had no temperature before he got the vaccine. The patient had bronchitis but no virus currently. He still has a bit of cough. He wanted to know if it gets worse was, he allowed to take an antibiotic and if taking antibiotics or prednisone will interfere with the vaccine as he already received the first dose. He was asking if it got worse, should he wait five more days and then go to the doctor. He wanted to know if prednisone affects the vaccine. The only side effect of COVID-19 Vaccine was his arm was hurting for about four to five hours on 12Jan2021, but that was it. The patient took two Tylenol. Arm soreness went away maybe five to seven hours later. The outcome of the event arm soreness was recovered while bronchitis was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,UNK,,Productive cough (minor cough and was spitting up phlegm),Medical History/Concurrent Conditions: Asthma,,,['Pain in extremity'],1,PFIZER\BIONTECH, 984427,TX,74.0,F,"it itches quite a bit/ Itching; pain and discomfort with her arm; pain and discomfort with her arm; couldn't get to sleep; rash looks like little blisters; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient started received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248 and expiry date: Nov2021), via an unspecified route of administration on her left arm on 12Jan2021 12:40 at a single dose for her age (COVID-19 immunization). Medical history included blood pressure (abnormal) and surgeries (had so many surgeries but none recently). Concomitant medications included ongoing atorvastatin for more than a year for blood pressure, ongoing amlodipine for more than year for blood pressure, ongoing losartan for more than year for blood pressure and ongoing terazosin from 09Dec2020 for blood pressure. The patient got her first injection on 12Jan2021 Tuesday and the following day (13Jan2021) she broke out with a rash on her right arm, right under her wrist and where you bend arm. She was asking if this a normal or expected side effect. The patient mentioned it was not in the arm where she received the vaccine. The rash was located in four places on her right arm; at the bend; maybe about two inches from where she bends it; a little bit on the outside of the arm and at the inside of her wrist. Last night (14Jan2021) she went to bed at 11PM and couldn't get to sleep until 3:00AM due to the pain and discomfort with her arm. Now (15Jan2021), it itches quite a bit. She put Neosporin (31254-7238-090 Lot 3259L or a 1 2/1 Expiration date Oct2021) on it and it helped but then when it dries up she can feel the itching again and was painful. The rash looks like little blisters. She is planning to get the next dose; she has to call in. Her next dose is due by 02Feb2021. The events did not require a visit to physician or ER. No prior vaccinations (within 4 weeks). The outcome of the events rash looks like little blisters, Pain in arm and it itches quite a bit/ Itching was not recovered and it was unknown for the other events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,UNK,ATORVASTATIN; AMLODIPINE; LOSARTAN; TERAZOSIN,,Medical History/Concurrent Conditions: Blood pressure abnormal; Surgery,,,"['Discomfort', 'Pain in extremity', 'Pruritus', 'Rash', 'Rash vesicular', 'Sleep disorder']",1,PFIZER\BIONTECH, 984428,FL,,M,"The caller and his wife are to receive the second dose 28 days after the first; This case has been considered invalid since there is no indication that the consumer experienced an event under Product BNT162B2, just medical inquiry. This is a spontaneous report from a contactable consumer (patient). The reporter reported similar event for two patient (reporter and his wife). This is the first case of 2 reports, for consumer himself. A male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL1283, on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient explained that yesterday he and his wife were scheduled to get the Modera vaccine in (address). They drove down there only to find out they ran out of the Moderna vaccine so they gave them the Pfizer one, which was fine, it was good actually. Now his second dose was based on the Moderna one and was scheduled at 28 days out. He was reading and found out we recommend it being given at 21 days. The patient explained the site said it was fine but he wanted to know if there's a problem with getting it at 28 days instead of 21 days or should he raise a fuss with the Health Department to make them give it to them at 21 days. He and his wife both got the shot that day with the same lot number: EL1283.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Unevaluable event'],1,PFIZER\BIONTECH, 984429,FL,78.0,F,"Chills; feeling very hot; arm also swelled, about 3 inches around the site; arm also swelled, about 3 inches around the site/ it was red and itchy; arm also swelled, about 3 inches around the site/ it was red and itchy; she woke up in a horrible sweat; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1284, expiry date: 30Apr2021), via an unspecified route of administration upper arm probably only about 4inches down from shoulder blade on the left on 12Jan2021 18:00 at a single dose for COVID-19 immunization. Medical history included COVID on 01Oct2020. Concomitant medication included rivaroxaban (XARELTO) as blood thinner. The patient previously took a flu and shingles shot and experienced her redness and swelling on her arm. The patient did not have vaccinations four weeks prior, and no additional vaccines were administered on the same date. She got it because she was told by her doctor that her antibodies will not last forever and it was still necessary to get it even though she already had COVID antibodies. She contracted COVID on 01Oct2020, that was the date when she had a positive test then she was last tested in December and she still had the antibodies then. She received her first dose of the vaccine on Tuesday 12Jan2021 and 24 hours later on 13Jan2021, she experienced chills and feeling very hot, which she took Tylenol extra strength for and it disappeared the next day. Her arm also swelled, not the whole arm, she would say about 3 inches around the site, 4 inches at the most and it was still swollen, it was red and itchy. Then she woke up in a horrible sweat but by the following morning it was gone. She wouldn't say it was a horrible reaction but she wanted to be certain she can go ahead and get the second shot which she had an appointment for. She said everything has resolved completely except for the swelling, her arm was still swollen, itchy, and red. Since the swelling, redness and itchiness began she would say it was slightly better than it was. The patient received the vaccine at an independent assisted living facility, not a military facility. The adverse events did not require a visit to the emergency room or physician's office. Outcome of the events chills, feeling very hot and woke up in a horrible sweat was recovered on 14Jan2021, while the remaining events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,UNK,XARELTO,,Medical History/Concurrent Conditions: COVID-19,,,"['Chills', 'Feeling hot', 'Hyperhidrosis', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,PFIZER\BIONTECH, 984430,,,M,"a little soreness in the arm; nauseated/cannot throw up anything, he was just continually nauseated; his stomach hurt; headache; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unspecified route of administration, on 10Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The wife stated that the patient received the Covid vaccine on 10Jan2021 with a little soreness in the arm on 10Jan2021 when he first received the shot. However, in a couple days in Jan2021, he got nauseated and his stomach hurt, but cannot throw up anything, he was just continually nauseated. He also had a headache for a while on Jan2021 but that's gone now. The patient's wife asked if there was something to help the patient with the nausea after receiving the vaccine and also asked if the patient should receive the second dose if he was experiencing nausea. The outcome of the event headache was recovered on Jan2021; nausea was not recovered; while the outcome of the other remaining events was unknown. Information about the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/01/2021,,UNK,,,,,,"['Abdominal pain upper', 'Headache', 'Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH, 984431,,,F,"her blood sugar is 260's; This is a spontaneous report from a Non-contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter indicated that she received her first dose of vaccine yesterday (14Jan2021) and her blood sugar is 260's on an unspecified date. She ate a slice of toast and exercised, asking if steroids are in vaccine. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,,,UNK,,,,,,['Blood glucose increased'],1,PFIZER\BIONTECH, 984432,MA,89.0,M,"losing night time sleep; welts on his body; rashes on delicate parts of belly, buttocks, scalp which were itchy/The rash gradually developed an itch; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899 and expiry date: 31Mar2021), via intramuscular route of administration on 30Dec2020 at 11:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021, a week after the injection, the patient experienced rashes on delicate parts of belly, buttocks, scalp which were itchy. The rash gradually developed an itch and he is now losing night time sleep. Patient stated that there were welts on his body on an unspecified date. He tried everything to stop the itch. He later stated there were objects across the counter that he tried, not prescription. One was alcohol and the other one was peroxide and a third one is Jergen's hand lotion and none worked. The outcome of the event itchy rash was not recovered, while unknown for the other events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/06/2021,7.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Rash', 'Rash pruritic', 'Sleep disorder', 'Urticaria']",1,PFIZER\BIONTECH,OT 984433,SC,44.0,M,"Fever/a temp of 101; feels something is different; intermittent minimal pain especially when he wakes up; Tachycardia; His CRP was up a little at 1.1; Nausea; Shortness of breath; Fatigue; Pain at injection site left shoulder; This is a spontaneous report from a contactable physician reporting for himself. A 44-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 28Dec2020, at a single dose on the left shoulder (arm left) for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 28Dec2020. Since receiving the vaccine, he has experienced multiple side effects at varying time points: pain at injection site left shoulder (experienced pain first day of receiving vaccine on 28Dec2020 and couple of days after fever (unspecified date) resolved (on an unspecified date); he was currently experiencing intermittent minimal pain especially when he wakes up; feels something is different; fever (experienced 08Jan2021); fatigue (developed 07Jan2021). He went to the ER on 08Jan2021 when he developed fever, nausea and shortness of breath which also resolved that day. When he went to ER, his CRP was up a little at 1.1. His PCR and antigen test was negative at that time (08Jan2021); a retest of PCR done 5 days after sxs started (unclear of time window) was negative. He was concerned that he had the fever many days after the vaccine. HCP was asking if any cases of fever and fatigue reported after 7 days (around the 10 day mark) of receiving the first dose. He stated that he is planning on taking the second dose. The patient is a physician calling about the Pfizer covid vaccine. He received his first dose on 28Dec2020. He had a little bit of pain in his left arm on same day, but it went away. About 10 days later, 07Jan2021, he had fever and fatigue. On 08Jan2021, he went to the ER with a temp of 101. He had tachycardia, nausea and shortness of breath. He was not admitted, stated his fever was controlled and his breathing was better. His oxygen was 100% and everything was ok and he was sent home. In the ER he had xrays and labs and everything was ok, except his CRP was a bit up. In the ER he had an antigen and pcr covid test (08Jan2021) and they both came back negative. About 4 or 5 days after the symptoms started, he had an outpatient repeat pcr test and nucleic acid rapid test (unspecified dates) and they both came back negative. He is on his way to get his second dose and he is asking if the symptoms could be side effects from the vaccine. Outcome the event fever was recovered on an unspecified date. Outcome of nausea and shortness of breath was recovered on 08Jan2021, while outcome of pain at injection site left shoulder was recovered on 28Dec2020. Outcome of the remaining events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['C-reactive protein increased', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Injection site pain', 'Laboratory test normal', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tachycardia', 'X-ray normal']",1,PFIZER\BIONTECH, 984434,,,F,"Not feeling well; Really bad headache; This is a spontaneous report from a non-contactable consumer via the Medical Information Team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the patient that she was not feeling well and have a really bad headache. The outcome of the events was unknown. No follow-up attempts are possible: information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Headache', 'Malaise']",UNK,PFIZER\BIONTECH, 984435,CA,26.0,F,"in the injection site she has a ""large mass hard and stiff""; large mass and it hasn't resolved. The area was really hard and stiff; breastfeeding; breastfeeding; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and baby. This is the maternal report. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284, expiration date not reported) via an unspecified route of administration on the left arm on 07Jan2021 07:00 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. She received the first dose of the vaccine on Thursday and in the injection site she has a ""large mass hard and stiff"", she's concerned about this and she would like to know what she can do. In the injection area a large mass and it hasn't resolved. The area was really hard and stiff. Wanted to know if she should be concerned or be seen. Received the first dose on 07Jan2021 and kind of had this issue with the injection arm all week and maybe noticed it Tuesday because she was afraid to sleep on that side. No history of problems with vaccines in past. She is due for the second dose on 28Jan2021. Caller later provides that she is breastfeeding at the moment, but no further details provided. The events did not result to a physician office and emergency room visit. Vaccination Facility Type was hospital. There were no additional vaccines administered on same date of Pfizer suspect. No relevant tests done and no family medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Event was reported as non-serious. Outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021051752 mother/baby",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Injection site induration', 'Injection site mass', 'Maternal exposure during breast feeding', 'Musculoskeletal stiffness', 'Sleep disorder']",1,PFIZER\BIONTECH, 984436,FL,78.0,M,"He was scheduled for the 2nd dose on 09Feb2021, longer than the 3weeks; dizzy; vertigo; This is a spontaneous report from a contactable consumer reporting for himself. A 78-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: not reported), via an unspecified route of administration on 12Jan2021 (around 11:00 or 11:30 AM) on left shoulder (arm left) for COVID-19 immunization. Vaccine was not administered at a military facility. There were no additional vaccines administered on same date of bnt162b2. He did not receive other vaccines 4 weeks prior to COVID-19 vaccination. Medical history and concomitant medications were none. The patient had his 1st dose on 12Jan2021. He was fine that day, but on the 13Jan2021, he woke up and was dizzy. He stated that he had no problem after having the shot, 15 minutes later, he had no problems; but, the next day he began having vertigo and dizziness. Vertigo and dizziness began 13Jan2021 at about 8:00 AM. This has continued the past 3 days. It is getting better, but he is wondering if that is a big problem. At the time of report, it's getting better but still have it. He asked if he should be concerned. It is quite a bit improved but it's still there. If he had to drive a car for an emergency, he thinks he could do it, but he wouldn't volunteer for that right now. He looked up all that stuff and it says that 20% of the people who take it have that. But when they list the side effects, they don't list dizziness until they list severe that is the only thing that has concerned him. He was scheduled for the 2nd dose on 09Feb2021, longer than the 3weeks. Outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dizziness', 'Vertigo']",1,PFIZER\BIONTECH, 984437,CA,27.0,F,"Local skin allergic reaction at the injection site; Swelling (about the size of a quarter) at the injection site; Red dots (about the size of a pencil eraser) that appeared around the injection site; some spots around the area approximately the size of pencil erasers; This is a spontaneous report from a contactable pharmacist (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302), intramuscular in the left upper deltoid muscle, on 13Jan2021 at 10:30, at a single dose, for COVID-19 vaccination. The patient had no medical history and concomitant medications. On 13Jan2021, the patient received first dose of vaccine and immediately (about 5 minutes after she received the vaccine at 10:35) developed non-severe local skin allergic reaction and swelling at the injection site, and some spots around the area approximately the size of pencil erasers. The patient had swelling (about the size of a quarter) at the injection site, along with red dots (about the size of a pencil eraser) that appeared around the injection site. The patient's vital signs were normal, her breathing was fine, and she had no swelling in her throat or lips. The patient took diphenhydramine hydrochloride (BENADRYL) 25 mg tablet, and a minute or two after taking the diphenhydramine hydrochloride tablet, all the symptoms went away. The patient was calling to see if she should receive the second dose of the vaccine. The patient asked if she should get the second COVID-19 vaccine dose, based on her adverse reactions after receiving the first dose. The patient recovered from the events on 13Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Immediate post-injection reaction', 'Injection site erythema', 'Injection site hypersensitivity', 'Injection site swelling']",1,PFIZER\BIONTECH,OT 984438,AZ,46.0,F,"Pain traveled up shoulder to ear; Pain traveled up shoulder to ear; strong dizziness that dissipated to minor dizziness within 15 minute wait; Pain in shoulder to neck; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date unknown), via an unspecified route of administration (left arm) on 13Jan2021 at 10:45 at a single dose for COVID-19 immunization. Medical history included Polycystic Ovarian Syndrome (PCOS), allergies, excessing calcification of veins and arteries, high blood pressure (BP), and known allergies to trees, grass and weeds. Concomitant medications included metformin (METFORMIN), rosuvastatin (ROSUVASTATIN), levothyroxine (LEVOTHYROXINE), and liothyronine (LIOTHYRONINE). The patient had no other vaccine in four weeks. On 13Jan2021, the patient experienced pain traveled up shoulder to ear, strong dizziness that dissipated to minor dizziness within 15-minute wait and pain in shoulder to neck has lessened 48 hours later, but still present. The patient had no COVID prior vaccination and had no COVID test post-vaccination. No treatment administered for the events. The events were resolving at the time of the report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/13/2021,0.0,UNK,METFORMIN; ROSUVASTATIN; LEVOTHYROXINE; LIOTHYRONINE,,Medical History/Concurrent Conditions: Allergy; Arterial calcification; Blood pressure high; Grass allergy; Pollen allergy; Polycystic ovarian syndrome; Ragweed allergy,,,"['Arthralgia', 'Dizziness', 'Ear pain']",1,PFIZER\BIONTECH, 984439,MA,81.0,F,"chills; tiredness; temperature was 100.8; sore arm with redness; sore arm with redness; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left arm on 12Jan2021 at a single dose for covid-19 immunisation. Medical history included covid-19 in Apr2020. There were no concomitant medications. On 13Jan2021, the patient experienced chills and tiredness and at the end of the day, her temperature was 100.8. The patient also experienced sore arm with redness in Jan2021. The patient stated that every once in a while, she get a shot and get a sore arm. She added that she noticed that her arm was more sore with redness that morning of reporting. The outcome of events chills, tiredness and temperature was 100.8 recovered on 14Jan2021, event sore arm with redness was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Body temperature increased', 'Chills', 'Erythema', 'Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH, 984440,,,M,"vomiting; does not feel good; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received a 1st shot of Pfizer vaccine yesterday (14Jan2021) and has been vomiting since this am (morning) (15Jan2021) and does not feel good (exact date unspecified; Jan2021). The outcome of events was unknown. This case is non-serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/01/2021,,UNK,,,,,,"['Feeling abnormal', 'Vomiting']",1,PFIZER\BIONTECH, 984441,,,F,"pain; headache; shiver; a fever which is currently 99.7 F; This is a spontaneous report received from a non-contactable consumer (patient's husband). A female patient of an unspecified age (reported as 62, unit not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date: unknown), via an unspecified route of administration, on 14Jan2021 10:00, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the vaccine yesterday (14Jan2021) around 10:00 and around 20:00, the patient experienced pain, headache, shiver and a fever which is currently 99.7 F. The reporter asked if the patient can use antipyretics before or after vaccination with the BNT162B2 vaccine. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/14/2021,0.0,UNK,,,,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 984442,,,M,"large swelling around his right leg; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of unspecified age received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 13Jan2021, at a single dose for COVID-19 immunization. The patient also received insulin (manufacturer unknown), via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. Medical history and concomitant medications were not reported. The patient got the COVID vaccine shot on Wednesday, 13Jan2021. At the morning of the report, 15Jan2021, he noticed a large swelling around his right leg. When he takes insulin through his right leg, he sees a few spots, but it usually goes away. This morning, when he woke up, a large area around the right site was swollen and it's not going away. He had been injected insulin around the same site a few times. He called to know if this was normal. The action taken in response to the event for insulin was unknown. Outcome of the event was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/15/2021,2.0,UNK,,,,,,['Peripheral swelling'],UNK,UNKNOWN MANUFACTURER, 984443,LA,48.0,F,"pain on left side of head that extends from left temple to above and behind my left ear and down the back of her neck; chills; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the first dose of bnt162b2 (lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 04Jan2021 at 13:30 at a single dose in the workplace clinic for COVID-19 immunization. There were no medical history and concomitant medications. The patient did not have COVID prior to vaccination. The patient is not pregnant. The patient experienced sharp pain on left side of head that extends from left temple to above and behind my left ear and down the back of her neck on 05Jan2021 at 15:00. Sudden onset and fades over 10-60 minutes and reoccurs off and on throughout the day. Also have noticed chills at the same time, on 05Jan2021 at 15:00. The patient did not receive treatment for the events. Outcome of event chills was not recovered while recovered on 05Jan2021 for the other event. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Headache', 'Neck pain']",1,PFIZER\BIONTECH, 984444,,,M,"light headiness; feel tightness around my chest; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 15Jan2021 11:15 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated ""I already reported the side effects to Pfizer before calling you. I received the vaccine today (15Jan2021) at 11:15 am. I felt light headiness for 5 to 19 minutes. I attributed this to the fact that I was fasting. I felt better after drinking water and a little walk. When I got home I started to feel tightness around my chest, no difficult breathing, no high pulse and no fever."" The patient wasnted to know if this was considered a severe allergic reaction that may require hospitalization. The outcome of the event light headiness was recovering, while feel tightness around my chest was unknown. Follow-up activities are possible, information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,UNK,,,,,,"['Chest discomfort', 'Dizziness']",UNK,PFIZER\BIONTECH, 984445,AR,30.0,F,"Shortness of breath Chest Heavy Lightheaded; Shortness of breath Chest Heavy Lightheaded; Shortness of breath Chest Heavy Lightheaded; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246, expiration date not reported), intramuscular on 14Jan2021 10:15 at single dose on the right arm for COVID-19 immunization. Medical history included chronic pain and known allergies to sulfa. The patient's concomitant medications were not reported. The patient experienced shortness of breath, chest heavy, lightheaded on 15Jan2021 at 10:00. The patient has not recovered from the events at the time of the report. The patient was not pregnant, has no prior COVID vaccination and was not tested for COVID post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/15/2021,1.0,SCH,,,Medical History/Concurrent Conditions: Chronic pain; Sulfonamide allergy,,,"['Chest discomfort', 'Dizziness', 'Dyspnoea']",1,PFIZER\BIONTECH,OT 984446,WV,42.0,F,"A rash that was located on the neck,chest and back area; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 08Jan2021 10:00 at a single dose on right arm for COVID-19 immunization. Medical history included type 2 diabetes mellitus. The patient was not pregnant at the time of vaccination. No known allergies. The patient was not diagnosed with COVID prior to vaccination. The patient's concomitant medications were not reported. The patient experienced a rash that was located on the neck,chest and back area on 08Jan2021 14:00. No treatment was given for the event. The patient has not been tested for COVID post vaccination. The patient recovered from the event on Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PHM,,,Medical History/Concurrent Conditions: Type 2 diabetes mellitus,,,['Rash'],1,PFIZER\BIONTECH, 984447,MS,47.0,M,"Transient numbness inside mouth buccal mucosa for about 3-5 minutes; Slight swelling upper left lip; 2cm petechia on border of left upper lip stopping at the midline; This is a spontaneous report from a contactable Other HCP (patient). A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), Intramuscular at left arm on 15Jan2021 11:00 at SINGLE DOSE for covid-19 vaccination. Medical history was reported as none. The patient's concomitant medications were not reported. On 15Jan2021 11:15, the patient experienced transient numbness inside mouth buccal mucosa for about 3-5 minutes, slight swelling upper left lip, 2cm petechia on border of left upper lip. Stopping at the midline. No treatment received for the events. No covid-prior-vaccination, no covid-tested-post-vaccination, no known allergies. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,MIL,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Hypoaesthesia oral', 'Lip swelling', 'Petechiae']",1,PFIZER\BIONTECH,OT 984450,OK,69.0,F,"temperature of 105.5 and stated it would fluctuate between 104-105; blurred vision; balance was off; first it was up around 163/71 and then over time it was really low 118/58; HR was high; body was jerking; arm that she got the injection in was dropping; dehydrated; urine is darker; real thirsty; extremely weak; tired and exhausted; feeling horrible; couldn't stay awake, fell asleep; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 14Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included left hip replaced on 16Nov2020 and had her right hip replaced on 29Dec2020. There were no concomitant medications. Patient reported that she got the shot at 1:30 pm and on the way home she started getting tired and exhausted on 14Jan2021. She got home and went right to bed. She felt like she couldn't stay awake, fell asleep and woke up about 6 pm then with a temperature of 105.5 and stated it would fluctuate between 104-105. She was just feeling horrible. At 7:30 pm, patient had a temperature of 103.5 and at 7:45 pm, her temperature was 104. On 14Jan2021, patient stated that she couldn't see straight, had blurred vision, having trouble walking, her balance was off and falling into walls. Her body was jerking and the arm that she got the injection in was dropping. Patient called her cardiology office, and was advised to take Tylenol 3-4 times per day and alternate it with Motrin. She was also taking coated 325 mg aspirin. She can hold her head up and was not jerking as much as she was. She was doing noticeably better. Patient had put ice bags on her groin, stomach and throat to try to cool down through the night. This brought temperature down to 103. She woke up at 12 am she was 102. Her temperature at the time of report was around 101-102. She took her blood pressure it was going crazy, first it was up around 163/71 and then over time it was really low 118/58 and heart rate was 130 for a while and went to 103. The back of her neck still felt so weak and she still feels extremely weak and exhausted. She went on to report that her HR was high and B/P was up but since then it has come down. The night of 14Jan2021, her b/p was low.On 14Jan2021, patient was also real thirsty and her urine was darker and was probably dehydrated and thought that she was real jerky muscle-wise, like she is not in control of anything last night. That she has not taken BP or heart rate on 15Jan2021, but it was not pounding today though. She was doing better today at the time of report. Patient was recovering from the events of fever, blurred vision, and balance was off; not recovered from tired, jerking, and dehydration. Outcome of remaining events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Hip replacement,,,"['Asthenia', 'Balance disorder', 'Blood pressure abnormal', 'Dehydration', 'Dyskinesia', 'Fatigue', 'Heart rate irregular', 'Malaise', 'Movement disorder', 'Pyrexia', 'Somnolence', 'Thirst', 'Urine abnormality', 'Vision blurred']",1,PFIZER\BIONTECH, 984452,TX,25.0,F,"numbness; tingling; shooting pain in her left trapezius; nerve pain in this area, mostly on the left medial trap next to her spine; This is a spontaneous report from a contactable healthcare professional (patient herself). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EK5730, expiry date unknown), intramuscular (right arm), on 12Dec2020 21:00 at single dose, for covid-19 immunization. Medical history includes unresolved dystonic reaction as of 2016 secondary to taking Lamictal (not fully resolved, currently being treated with baclofen and gabapentin). Concomitant medications in two weeks included gabapentin for unresolved dystonic; methylphenidate hydrochloride (CONCERTA); clonidine; vilazodone hydrochloride (VIIBRYD); ondansetron (ZOFRAN [ONDANSETRON]); doxycycline; and baclofen for unresolved dystonic. The patient previously took lamotrigine (LAMICTAL) and experienced dystonic reaction and allergies. The patient experienced numbness, tingling, and shooting pain in her left trapezius one day on 17Dec2020, after the first injection; and these lasted two weeks. While the numbness and tingling have resolved, the patient sometimes still experiences nerve pain in this area, mostly on the left medial trap next to her spine from 17Dec2020. These events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the adverse events. The patient was recovering from the events shooting pain in her left trapezius and; nerve pain in this area, mostly on the left medial trap next to her spine. The patient recovered from the events numbness and tingling on an unspecified date. The patient had no other vaccine in four weeks. The patient had a nasal swab test post-Covid vaccination on 02Jan2021 with results of negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/12/2020,12/17/2020,5.0,PVT,GABAPENTIN; CONCERTA; CLONIDINE; VIIBRYD; ZOFRAN; DOXYCYCLINE; BACLOFEN,,"Medical History/Concurrent Conditions: Dystonic reaction (secondary to taking Lamictal not fully resolved, currently being treated with baclofen and gabapentin)",,,"['Hypoaesthesia', 'Neuralgia', 'Pain', 'Paraesthesia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,OT 984453,,,F,"allergic reaction; hives and itching in the administration site; hives and itching in the administration site; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked for information if she should be administrated with the second dose of the Pfizer's COVID-19 vaccine if she developed side an allergic reaction to the first dose of the vaccine. The patient reported that after the first dose of the Pfizer's COVID-19 vaccine she had hives and itching in the administration site on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Hypersensitivity', 'Injection site pruritus', 'Injection site urticaria']",1,PFIZER\BIONTECH, 984473,WI,,F,"blotchy rash first noted above BP cuff on right arm, but quickly spread up neck and down trunk; Blood pressure (BP) 146/88; feeling hot and tingly on neck and all the way down to her legs; her throat feeling hot and tingly; her throat feeling hot and tingly; Heart rate (HR)-140- 150; not feeling well; Got a rush of feeling very warm and shaky; Got a rush of feeling very warm and shaky; patient is pale, diaphoretic and has a rapid bounding pulse; patient is pale, diaphoretic and has a rapid bounding pulse; patient is pale, diaphoretic and has a rapid bounding pulse; This is a spontaneous report from a contactable pharmacist. A female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 24Dec2020 09:45 AM at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Events onset date was 24Dec2020. Patient reports not feeling well. Got a rush of feeling very warm and shaky. Upon assessment patient is pale, diaphoretic and has a rapid bounding pulse. Moved patient to exam room where we assisted her to lay down. Hooked her up to vitals machine for a set of vitals. Heart rate (HR)-140- 150, Blood pressure (BP) 146/88, O2 100%, R-24. Upon patient laying down she started to complain of her throat feeling hot and tingly. She began to develop a blotchy rash first noted above BP cuff on right arm, but quickly spread up neck and down trunk. Assessed mouth and throat, no swelling of tongue or lips noted. Patient still c/o feeling hot and tingly on neck and all the way down to her legs. Blotchy rash had subsided. HR dropping to 80-90 and BP came down to 124/82. O2 remained 100% throughout. Medical response called. Continued to monitor and talk with patient until response team arrived. Patient transferred to Emergency room (ED). The outcome of event Feeling of warmth and tingly was not recovered. The outcome of Blotchy rash was recovering. The outcome of Blood pressure (BP) 146/88 was recovered on 24Dec2020. The outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported events were likely related to the first dose of bnt162b2 (Pfizer-BioNTech COVID-19) due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,PVT,,,,,,"['Feeling hot', 'Heart rate increased', 'Hyperhidrosis', 'Malaise', 'Nervousness', 'Pallor', 'Paraesthesia', 'Pharyngeal paraesthesia', 'Rash', 'Rash macular', 'Throat irritation']",1,PFIZER\BIONTECH, 984500,MA,,U,"Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program, Pfizer First Connect. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the second of 20 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 984501,MA,,U,"Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the third of 20 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event tested positive for the virus (COVID-19) based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 984502,MA,,U,"Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine.; This is a spontaneous report from a contactable nurse. This nurse reported the same event for 20 patients (15 residents and 5 staff members). This is the fourth of 20 reports. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient has tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if the patient should receive the second dose. Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and tested positive for the virus (COVID-19) in Jan2021. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection. Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 984503,MA,,U,"Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse received from Pfizer sponsored program Pfizer First Connect. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the 5th of 20 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, the lack of efficacy cannot be excluded for vaccine BNT162B2.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 984504,MA,,U,"Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the sixth of 20 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and tested positive for the virus (COVID-19) in Jan2021. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection. Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,OTH,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 984505,MA,,U,"Patient tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the seventh of 20 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,OTH,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 984506,MA,,U,"Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program Pfizer First Connect. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the ninth of 20 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, the lack of efficacy cannot be excluded for vaccine BNT162B2. ,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 984507,MA,,U,"Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program Pfizer First Connect. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the twelfth of 20 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 cannot be completely excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 984508,MA,,U,"Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program Pfizer First Connect. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the 13th of 20 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,OTH,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 984509,MA,,U,"patient tested positive for the virus (COVID-19) after the first dose of the vaccine; patient tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via the Pfizer-sponsored Program. This nurse reported the same event for twenty (20) patients (15 residents and 5 staff members). This is the sixteenth (16th) of the twenty (20) reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,OTH,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 984510,MA,,U,"Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the seventeenth of 20 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 984511,MA,,U,"Tested positive for covid after 1st dose received on 03Jan2021; Tested positive for covid after 1st dose received on 03Jan2021; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse reported same event for 20 patients (15 residents and 5 staff members). This is the 18th of 20 reports. A patient of unspecified age and gender receive the first dose bnt162b2 (BNT162B2 also reported as Pfizer-Biontech Covid-19 Vaccine, lot/batch number and expiry date not reported), via an unspecified route of administration on 03Jan2020 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient was tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. The outcome of event was unknown. Information on Lot/Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive for the virus (COVID-19) based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2020,01/01/2021,364.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 984512,MA,,U,"Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the nineteenth of 20 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 984513,MA,,U,"Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the 20th of 20 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and tested positive for the virus (COVID-19) in Jan2021. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection. Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 984614,OK,,U,"Contracted COVID-19 11 days after first jab; Contacted COVID-19 11 days after first jab; This is a spontaneous report from a contactable nurse (patient) via a Pfizer sales representative. A patient of unspecified age and gender received the first dose of bnt162b2 (BNT162B2) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient contracted COVID-19 11 days after first jab. Outcome of the event was unknown. Information about Lot/Batch number is requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 984615,IL,,U,"patient took the PCR COVID test for the purpose of travelling and it was positive; patient took the PCR COVID test for the purpose of travelling and it was positive; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs). A contactable physician (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported the patient was antibody-antigen negative before taking the vaccine. Then the patient took the PCR COVID test for the purpose of travelling and it was positive on an unknown date. Outcome of the events was unknown. Information about Lot/Batch number is requested.; Sender's Comments: Based on the time association, the lack of efficacy cannot be excluded for vaccine BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 984616,MT,78.0,F,"felt tired; nausea; headache; short of breath; rapid/shallow breathing; rapid/shallow breathing; fast heart rate (100 bpm); low grade fever; felt very weak; pleuralpericardial effusion; pleuralpericardial effusion; This is a spontaneous report from a contactable consumer. A non-pregnant 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 16Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included allergic to opioids, allergy to fish, cirrhosis with portal hypertension, parkinsonism, heart blockage, type 2 diabetes, depression, early dementia. The patient previously took morphine and experienced drug hypersensitivity. There was unspecified concomitant medication. The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced allergic to morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced felt tired, nausea, headache, short of breath, rapid/shallow breathing, fast heart rate (100 bpm), low grade fever, felt very weak, pleuralpericardial effusion on 16Jan2021. All the events were reported with the seriousness criteria of disability, hospitalization and being life-threatening. The patient was hospitalized for the events for 4 days. After the injection, from 0 to 24 hours the patient felt tired, had nausea, a headache, short of breath then at about 24 hours post injection developed rapid/shallow breathing, fast heart rate (100 bpm) low grade fever and felt very weak. The patent was taken to the emergency room (ER) at 30 hours post injection and it was determined (Xray, CTA & EKG) that she had a pleuralpericardial effusion. She was flown by air life to another ER for treatment. The patient underwent lab tests and procedures on 16Jan2021 which included angiogram (CTA): had a pleuralpericardial effusion; body temperature: low grade fever; electrocardiogram (EKG): had a pleuralpericardial effusion; heart rate: 100 beats per minute (bpm); X-ray: had a pleuralpericardial effusion. The patient had a rapid nasal swab on 17Jan2021 which was negative. Therapeutic measures were taken as a result of the events and included unspecified medications & oxygen therapy. The outcome of the events was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.",Not Reported,,Yes,Yes,4.0,Yes,N,01/16/2021,01/16/2021,0.0,SEN,,,Medical History/Concurrent Conditions: Cirrhosis liver; Dementia; Depression; Drug allergy; Fish allergy; Heart block; Parkinsonism; Portal hypertension; Type 2 diabetes mellitus,,,"['Angiogram', 'Angiogram abnormal', 'Asthenia', 'Dyspnoea', 'Electrocardiogram abnormal', 'Fatigue', 'Headache', 'Heart rate increased', 'Hypopnoea', 'Nausea', 'Pericardial effusion', 'Pleural effusion', 'Pyrexia', 'Respiratory rate increased', 'SARS-CoV-2 test negative', 'X-ray abnormal']",1,PFIZER\BIONTECH, 984617,FL,98.0,F,"Patient passed su hospital on 23Jan2021 stopped breathing; complained of not feeling well; had an inflamed gall bladder; This is a spontaneous report from a contactable consumer. A 98-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiry date unknown), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medication reported as has received other medications (unspecified) within 2 weeks. The patient passed in hospital on 23Jan2021 with stopped breathing. Day after vaccine on 17Jan2021, the patient complained of not feeling well, went to hospital where was told she had an inflamed gall bladder. The events caused patient hospitalization for 4 days. The cause of death reported as stopped breathing. It was unknown if autopsy done. Prior to vaccination, the patient not diagnosed with COVID-19. The outcome of the event breathing arrested was fatal, outcome of the other events was unknown.; Reported Cause(s) of Death: Stopped breathing",Yes,01/23/2021,Not Reported,Yes,4.0,Not Reported,N,01/16/2021,01/17/2021,1.0,SEN,,,,,,"['Cholecystitis', 'Death', 'Malaise', 'Respiratory arrest']",1,PFIZER\BIONTECH, 984620,KS,61.0,M,"Got the COVID-19 vaccine shot and was COVID positive the day after; Got the COVID-19 vaccine shot and was COVID positive the day after; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiration date not reported), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), atorvastatin. It was reported that the patient got the COVID-19 vaccine shot last Saturday (09Jan 2021) and was COVID positive on Sunday (10Jan2021), the day after. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/10/2021,1.0,PVT,LISINOPRIL HCTZ; ATORVASTATIN,,Medical History/Concurrent Conditions: Blood pressure high; High cholesterol,,,['SARS-CoV-2 test positive'],UNK,PFIZER\BIONTECH, 984637,NE,38.0,F,"Rught MCA Stroke; This is a spontaneous report from a contactable nurse (patient). A 39 years old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscular on 16Dec2020 10:15 at the first single dose at right arm for covid-19 immunisation. Medical history included Hodgkin's disease. Concomitant medication included colecalciferol (VITAMIN D3 1000). The patient experienced rught MCA stroke on 25Dec2020 06:15. Seriousness criteria reported as hospitalization, life threatening. The patient was hospitalized for rught MCA stroke for 3 days. The patient underwent lab tests and procedures which included Nasal Swab: negative on 25Dec2020. The patient received unspecified treatment for rught MCA stroke. The outcome of event was recovered.; Sender's Comments: The subject had medical history included Hodgkin's disease. The reported stroke was more likely an intercurrent disease, and unlikely causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,12/16/2020,12/25/2020,9.0,PVT,VITAMIN D3 1000,,Medical History/Concurrent Conditions: Hodgkin's disease,,,"['Cerebrovascular accident', 'Viral test negative']",1,PFIZER\BIONTECH,OT 984701,AZ,29.0,F,"1week after second shot started experiencing facial nerve pain. No medical history of any pain before. Negative etiology from dentist. Received 5 day course of prednisone 50mg daily which resolved pain, however 1 day after finishing course pain returned. Worse at night with bouts of pain every 30 minutes when trying to sleep. Received steroids and carbamazepine from internal medicine doctor but this has not helped for this episode. Max doses of Tylenol and ibuprofen have not helped this episode.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/14/2021,01/21/2021,7.0,UNK,None,None,None,,None,"['Facial pain', 'Neuralgia', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 984708,WI,31.0,F,"At 6 hours from vaccination (day 0), very strong shoulder pain. Needed tylenol, have never needed tylenol after a shot in my life before. Shoulder pain continued through to the day after vaccination (day 1) - had to take tylenol around the clock. By day 2 it was normal. On Day 0, around 8-10 hours post vaccination, I had rigors which lasted a few mins, chills, fevers, myalgias. Took tylenol. On day 1, about 17 hours from vaccination, I woke up with lightheadedness, dizziness, nausea. Felt like I was going to pass out. Laid down, and it passed. Continued with myalgias, fevers, chills, fatigue on day 1. By day 2, I felt normal. I took tylenol day 0 and day 1.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,none,none,Migraine with Aura,,none,"['Arthralgia', 'Chills', 'Dizziness', 'Fatigue', 'Myalgia', 'Nausea', 'Pyrexia']",UNK,MODERNA, 984729,CA,58.0,M,"I developed a 108.3 degree fever 16 hours after injection. Also swollen lymph glands in left armpit, inflammation on left side of body, headache, extreme fatigue",Not Reported,,Yes,Not Reported,,Not Reported,N,01/16/2021,01/17/2021,1.0,PVT,"25 mg Atenolol, amlodipine 10mg, hydrochlorothiazide 25mg",none,high blood pressure,,wellbutrin,"['Fatigue', 'Headache', 'Inflammation', 'Laboratory test', 'Lymphadenopathy', 'Pyrexia']",2,PFIZER\BIONTECH,IM 984733,MN,56.0,F,"She became acute short of breath. Called EMS. On their arrival she was nearly unresponsive. Bagged. NOT hypotensive. HYPERCARBIC. Difficult intubation. Transferred to our facility on VENT with bilateral pulmonary infiltrates, wheezy with size 6 ETT from outside facility.",Not Reported,,Yes,Yes,,Not Reported,N,01/28/2021,01/28/2021,0.0,PVT,Outpatient Medications azelastine (ASTELIN) 137 mcg/spray nasal spray Spray 2 sprays into each nostril Every 12 hours fluconazole (DIFLUCAN) 100 mg tablet Take 100 mg by mouth 1 time per day prochlorperazine (COMPAZINE) 10 mg tablet Take,"Breast cancer with hx radiation and current chemotherapy. Posterior glottis stenosis,",Hx asthma,,"Peanut oil, molds, and smut.","['Chest X-ray', 'Computerised tomogram neck', 'Computerised tomogram thorax', 'Dyspnoea', 'Endotracheal intubation complication', 'Hypercapnia', 'Laboratory test', 'Lung infiltration', 'Mechanical ventilation', 'Unresponsive to stimuli', 'Wheezing']",2,PFIZER\BIONTECH,IM 984750,MN,55.0,M,"48 hours after round 1 of the moderna vaccine, Patient developed severe diarrhea and vomiting. The diarrhea and vomiting led to acute dehydration which substantially lowered blood pressure. Patient was then brought to ER and hospitalized for 2 days related to the severe dehydration. Patient has not had similar symptoms in previous 2 years to this incident.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/10/2021,01/12/2021,2.0,SEN,"Amitriptyline, Aspirin, Atorvastatin, cloZAPine, Depakote, Ferrous Sulfate, Gemfibrozil, Glycopyrrolate, Lisinopril, miralax, Mirtazapine, Multivitamin, OLANZapine, Phenytoin",no other non-chronic illness during that time,"Schizophrenia, Diabetes Mellitus type II, Hyperlipidemia",,NKDA,"['Blood pressure decreased', 'Dehydration', 'Diarrhoea', 'Vomiting']",1,MODERNA,IM 984751,,79.0,M,"a fib with RVR. Patient also had viral like symptoms day after the vaccine (fatigue, chills)",Not Reported,,Not Reported,Yes,,Not Reported,N,01/25/2021,01/28/2021,3.0,OTH,Terazocine,none,none,,none,"['Atrial fibrillation', 'Chills', 'Fatigue', 'Laboratory test normal']",UNK,PFIZER\BIONTECH, 984752,HI,77.0,M,"Feeling normal before the vaccine, with exception of slight cough that Dr said was due to allergies. But then a fever, chills and aches the day after vaccine. Two days after, still febrile and feeling worse and experiencing shortness of breath and lightheadedness. Fatigue, fever and lightheadedness continue for three more days. On the 6th day post-vaccine, taken to ER and admitted to hospital with a pneumonia and blood counts dangerously low. Received 3 blood transfusions and is receiving 2 different IV antibiotics to treat pneumonia. Still in hospital and waiting to see how blood counts go. I can?t say the vaccine CAUSED this, but it all happened rapidly, immediately following the vaccine.",Not Reported,,Yes,Yes,3.0,Not Reported,N,01/21/2021,01/22/2021,1.0,PVT,Low dose blood pressure medication,None,Sinusitis annually,,Hay fever allergies,"['Blood count abnormal', 'Chills', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Pain', 'Pneumonia', 'Pyrexia', 'Transfusion']",1,MODERNA,SYR 984761,CA,49.0,F,"Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my entire right arm. I was only able to lift my arm up to my shoulder. Very fatigue, body aches, dizziness and drunken feeling. Day 3: less arm soreness. Very fatigued and dizzy. Body aches, joint and muscle pain. Pain in my body. Day4: muscle and joint pain, still very fatigued and my vision began to become blurry. Day 5: fatigue, joint pain, headache and blurred vision has worsened. Day 6: fatigue joint pain, sever headache, dizzy, vision is still bad. I contacted the ophthalmologist and Optometry to schedule an appointment.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/22/2021,01/22/2021,0.0,PUB,"Pristiq, Linzess, Valtrex, lunesta, vit d, zinc, fish oil,","Srogens, fibromyalgia, demyelination, back issue,",Back pain,,Ativan and morphine,"['Arthralgia', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Feeling drunk', 'Headache', 'Injected limb mobility decreased', 'Injection site pain', 'Myalgia', 'Pain', 'Pain in extremity', 'Vision blurred']",1,PFIZER\BIONTECH,SYR 984774,IL,37.0,F,Sudden-onset R sided sensorineural hearing loss,Not Reported,,Not Reported,Not Reported,,Yes,N,01/06/2021,01/13/2021,7.0,PVT,Tri-Lo-Sprintec Tretinoin cream,None,Atopic dermatitis History of allergic rhinitis,,None,"['Acoustic stimulation tests abnormal', 'Deafness neurosensory']",2,PFIZER\BIONTECH,IM 984790,MI,69.0,M,"Pt reported to Health Services at approximately 2200PM on 1/28/21 after receiving vaccination 1/28/21 at 0925AM. He reported complaints of dyspnea beginning at 2000PM but did not report until 2200. He presented with an SpO2 of 81% on RA, HR 121, RR 44, BP 180/96, and temp 100.4. Previously, the patient required O2 therapy and oral steroids to recover from COVID 19 infection diagnosed on 12/1/2020. He was asymptomatic at the time of vaccination. He was treated with O2 therapy and Tylenol and states feeling much better this morning (1/29/21) at 0630AM. He continues to have a low grade fever of 100.6, and Tylenol provided.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,OTH,"Aspirin 81mg 1 QD, TUMS 750mg 1 TID PRN, Multi Vit 1 QD, Psyllium capsule 0.52GM 1 QD, Tamsulosin 0.4mg 1 HS, AREDS 2 1 BID, Vitamin D 2000IU 1 QD",COVID 19 diagnosis 12/1/2020. Long convalescence including O2 therapy afterward. Asymptomatic at the time of vaccination.,"Osteoarthritis, enlarged prostate, cirrhosis of the liver, macular degeneration, cataract, cervicalgia, functional dyspepsia",,NKA,"['Dyspnoea', 'Pyrexia']",1,MODERNA,SYR 984929,AR,35.0,F,"? Day 10 after vaccine #1 upper lip swelling AKA angioedema ? Day 6 post vaccine #2 lower right lip and upper right lip swelling. Scratchy throat ? Day 10 post vaccine #2 wheezing like an asthma attack ? Day 12 post vaccine #2 Left, lower lip swelling, tingling in my tongue ? itchy for 2 weeks, 14 days post vaccine #2. Developed a sporadic, ever changing rash ? Day 16 post vaccine #2 a different, new rash",Not Reported,,Yes,Not Reported,,Not Reported,U,12/21/2020,12/31/2020,10.0,PVT,"Blisovi (birth control), one dose of duexis, Lil Critters Immune C + zinc & vit d",None,None,,NKA,"['Angioedema', 'Full blood count', 'Lip swelling', 'Paraesthesia oral', 'Pruritus', 'Rash', 'Throat irritation', 'Wheezing']",2,PFIZER\BIONTECH,IM 984959,VT,31.0,F,"The injection site is circled with ink and is one finger breadth below the acromion. Patient presents with pain and poor range of shoulder motion. Suspect vaccine was injected into her subacromial bursa, or possibly shoulder joint, resulting in injury (SIRVA)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/29/2021,2.0,OTH,None,None,None,,History of intolerance to Amoxicillin/Clavulanate. No know allergies.,"['Injection site movement impairment', 'Injection site pain', 'Product administered at inappropriate site']",1,MODERNA,IM 984970,MN,29.0,F,"Pregnant. Due august 2, 2021 Having fever (up to 100 F), headache, nausea, vomiting, aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,PVT,Hydrocortisone Fludrocortisone Levothyroxine Prenatal Vitamin D DHA Claritin,None,Addison?s disease Hashimoto?s thyroiditis Pregnancy,,Sulfa medications,"['Exposure during pregnancy', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,SYR 984998,WI,42.0,F,Pt diagnosed with Bell's Palsy 3 days after receiving dose,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/16/2021,4.0,PVT,Allegra 180 mg,None,None,,PCN,['Facial paralysis'],1,MODERNA,IM 985004,MI,58.0,F,"The week of 1/18/2021 The patient complained of Abdominal pain and called off work (we are also her employer) She was seen for constipation on 1/20/2021. Employee returned to work on 1/25/2021 Had occasional episodes during work where she would sweat and become tired but would rest until she felt better. On the Night of 1/27/2021 she was feeling fine no issues, later in the shift a co worker found her unresponsive, CPR was initiated but unsuccessful.",Yes,01/27/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/27/2021,19.0,PVT,None,none,Cardiac Issues. Hx of cardiac Stent but unknown in-depth.,,Codeine Penicillin V,"['Abdominal pain', 'Constipation', 'Death', 'Fatigue', 'Hyperhidrosis', 'Impaired work ability', 'Resuscitation', 'Unresponsive to stimuli']",1,UNKNOWN MANUFACTURER,IM 985018,IN,34.0,F,"Fatigue, arm pain, contractions (baby due date 7/30/2021)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/28/2021,1.0,PVT,"Zyrtec, fluoxetine, levothyroxine, prenatal vitamins, low dose aspirin, amlodipine, diclegis",1st COVID 19 vaccine dose,"High blood pressure, hypothyroidism",,Lactose intolerant,"['Exposure during pregnancy', 'Fatigue', 'Pain in extremity', 'Uterine contractions during pregnancy']",UNK,PFIZER\BIONTECH,SYR 985020,MA,31.0,F,"24 weeks pregnant due 5/11/21, unknown birth weight Symptoms started as sharp stomach pains around belly button which I believed to be constipation or gas due to pregnancy. I began to feel nauseous around 6-6:30 on the night of 1/21/21 (vaccine administered on 1/20/21). I then began vomiting until approximately 8:00 pm. The nausea persisted until some point in the night, but I fell asleep so I?m unsure when. Stomach pain persisted the same as the nausea.. woke up next morning feeling much better, but dehydrated. Still unsure if stomach pain is related, but positive the nausea and vomiting was from vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/21/2021,1.0,OTH,"Zofran, prenatal vitamins",None,None,,None,"['Abdominal pain upper', 'Dehydration', 'Exposure during pregnancy', 'Nausea', 'Vomiting']",1,MODERNA,IM 985024,TX,31.0,M,"13 hours after injection: Typical chills, body aches, cold sweats lasting 24 hours. Relief with Acetaminophen and Ibuprofen. On 1/25/21 around 4:00 PM: Following intercourse, shortness of breath and mild chest pain. Unable to go for walk with son and wife due to fatigue and mild chest pain. Discomfort ameliorated with rest. On 1/26/21 around 6:00 AM: Shortness of breath and chest pain in shower with minimal effort. Pulse around 140 BPM. Drove to ER for workup. Transferred to hospital for admission.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/23/2021,01/25/2021,2.0,PVT,None,None,None,,None,"['Chest pain', 'Chills', 'Cold sweat', 'Discomfort', 'Dyspnoea', 'Echocardiogram normal', 'Electrocardiogram normal', 'Fatigue', 'Myocarditis', 'Pain', 'Troponin increased']",2,PFIZER\BIONTECH,IM 985117,FL,58.0,F,"Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the top of her head felt funny. At this point on site ARNP was called over to Patient. and both myself and ARNP noticed flushing on face and neck and hives on neck area. On site EMS notified and came over. Patient then self medicated with 2-25 mg Benadryl. Patient exhibited mild cognitive slowing with some mild speech and thought degradation...felt funny....not sure what she felt.... Physical symptoms noted above showed some mild sign of improvement? Clinicians insisted that patient should be taken to hospital of choice via ambulance. Patient was taken to clinic where she was under observation, put on IV saline and administered IV steroid, dexamethasone. After approximately two hours patient was released and instructed to take over-the-counter Benadryl every six hours for six days and one Pepcid per day for six days.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,SEN,"valsartan, amyltriptilline, synthroid",none,"hashimotos,",,"sulfa drugs, shellfish","['Cognitive disorder', 'Dry mouth', 'Feeling abnormal', 'Flushing', 'Speech disorder', 'Thinking abnormal', 'Thirst', 'Urticaria']",1,PFIZER\BIONTECH,IM 985188,MN,34.0,F,"12 hours post vaccination had chills and body aches, restless sleep. The morning after whioe body soreness, tired, nauseous, pain at injection site, headache. Took 1000 mg Tylenol at 11 am and 7 pm. Day 2 Body aches, tired. Currently 12 weeks pregnant as of 2nd dose date.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,PVT,None,None,Hypothyroidism,,None,"['Chills', 'Exposure during pregnancy', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pain', 'Poor quality sleep']",2,PFIZER\BIONTECH,IM 985205,OH,75.0,M,Patient was feeling dizzy and under the weather after the vaccination. The following day he died in his sleep during a nap.,Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,UNK,"Yes, but caller does not know what they are.",No,None,,No,"['Death', 'Dizziness', 'Malaise']",1,MODERNA,IM 985222,IA,43.0,F,Flareup of myasthenia gravis. Condition deteriorated and she was urgently intubated due to myasthenia crisis. Received steroids and IVIG and was successfully extubated. Therapies worked with her and did well. Discharged on oral steroids with Neurology follow up in 2 weeks.,Not Reported,,Yes,Yes,5.0,Not Reported,Y,01/18/2021,01/18/2021,0.0,PVT,pyridostigmine 60mg 3x daily Epipen 0.3mg IM prn,,myasthenia gravis,,Shellfish,"['Condition aggravated', 'Endotracheal intubation', 'General physical health deterioration', 'Immunoglobulin therapy', 'Myasthenia gravis']",1,MODERNA,IM 985312,AL,75.0,M,Experienced a witness arrest at home on 1/27/21 while watching TV. Wife performed CPR prior to EMS arrival. Pt intubated using King Airway due to edema and bleeding. Admitted to ICU on Vent,Not Reported,,Yes,Yes,,Not Reported,U,01/26/2021,01/27/2021,1.0,PVT,,"Hyperlipidema, Stage four Kidney disease, Congestive Heart Failure","CHF, Kidney Disease",,Sulfamethizole,"['Cardiac arrest', 'Computerised tomogram abdomen', 'Computerised tomogram head', 'Computerised tomogram thorax', 'Endotracheal intubation', 'Haemorrhage', 'Intensive care', 'Mechanical ventilation', 'Oedema', 'Resuscitation', 'SARS-CoV-2 test negative']",1,MODERNA,IM 985367,KY,83.0,M,"TESTED POSITIVE FOR COVID-19 1-7-2021, TRANFERRED TO HOSPITAL ON 1-18-2021. HE READMITTED TO THE FACILITY ON 1-21-2021 WITH HOSPICE SERVICES AND EXPIRED ON 1-25-2021.",Yes,01/25/2021,Not Reported,Yes,4.0,Not Reported,N,01/06/2021,01/18/2021,12.0,SEN,Mucinex Tablet Extended Release 12 Hour 600 MG (guaiFENesin ER) Acetaminophen Tablet 500 MG cloZAPine Tablet 25 MG Remeron Tablet (Mirtazapine) Aspercreme Lidocaine Patch 4 % (Lidocaine) Cyanocobalamin Tablet 500 MCG Cholecalciferol,COVID-19 + DAY AFTER THE FIRST DOSE OF THE VACCINE,PARKINSON'S DISEASE HTN BPH CROHN'S DEMENTIA ANXIETY OA DDD ALLERGIC RHINITIS VITAMIN D DEFICIENCY,,ATIVAN GEODON,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 985429,TX,50.0,F,"10:50am shot was given, 11am patient started to get cold and having a headache, 11:10am patient started to have hard time breathing and severely cold and BP was rising. 911 was called and patient was transported to hospital where she was admitted.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/28/2021,01/28/2021,0.0,SEN,,,,,,"['Blood pressure increased', 'Dyspnoea', 'Feeling cold', 'Headache']",2,PFIZER\BIONTECH,SYR 985449,,87.0,F,Patient was an 87 y/o female admitted for septic shock. She was started on and eventually maxed on 3 pressors. CT abd showed colonic obstruction with dilatation of large and small bowel. Patient was made DNR in the ED. Palliative care consulted on case. Family opted for comfort care. Patient was asystole on monitor. No spontaneous breath/cardiac sounds ausculted. Patient did not withdraw to pain. Pupils fixed and dilated. She was pronounced and 1230 on 1/28/21,Yes,01/28/2021,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/28/2021,1.0,PVT,,colonic obstruction with dilatation of large and small bowel,,,,"['Cardiac arrest', 'Cardio-respiratory arrest', 'Computerised tomogram abdomen abnormal', 'Death', 'Intestinal dilatation', 'Large intestinal obstruction', 'Pupil fixed', 'Septic shock', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH, 985451,KY,101.0,F,"COVID-19 + 1/11/2021, EXPIRED ON 1-24-2021",Yes,01/24/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/24/2021,18.0,SEN,predniSONE Tablet 20 MG Mucinex Tablet Extended Release 12 Hour 600 MG (guaiFENesin ER) Acetaminophen Tablet 500 MG RisaQuad Capsule (Probiotic Product) BISACODYL 10MG SUPPOSITORY Morphine Sulfate (Concentrate) Solution 100 MG/5ML H,,VASCULAR DEMENTIA HEART FAILURE BULLOUS PEMPHIGOID,,NKA,"['Death', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 985456,FL,87.0,M,"Patient had auditory hallucinations same evening as the shot, then began to have generalized weakness, worsening SIADH symptoms and visual hallucinations leading to subsequent hospitalization for 5 days and the SNF for 10 days. Never had hallucinations prior to event",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,"Desmopressin 0.1mg (nightly), Simvastatin 40mg, Sodium Chloride (1 gm TID), Omeprazole 20mg QD, ASA 81mg QD, Calcium 500mg + D, Glucosamine Chondroitin, Smarty Pants Vitamin, Magnesium",None,"SIADH, Hyponatremia, Hypomagnesemia, Dementia (Mild)",,NKDA,"['Asthenia', 'Condition aggravated', 'Hallucination, auditory', 'Hallucination, visual', 'Inappropriate antidiuretic hormone secretion']",1,MODERNA,IM 985480,,73.0,F,"after second dose of vaccine, patient had Internal jugular (IJ) vein thromboembolism, acute, right; Mucositis; Sore throat. Admitted for Chemotherapy-induced neutropenia; Infection of venous access port. Discharged after one day.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/26/2021,01/27/2021,1.0,PVT,,"hyperlipidemia, uterine leiomyosarcoma with metastasis to the right lung","hypertension, diabetes mellitus type 2",,STATINS-HMG-COA REDUCTASE INHIBITORS,"['Catheterisation venous', 'Embolism', 'Infection', 'Mucosal inflammation', 'Neutropenia', 'Oropharyngeal pain']",2,PFIZER\BIONTECH, 985501,OH,89.0,F,"family states seemed short of breath since after the covid vaccine. Staff said beginning on 1/22/21 the patient seemed sluggish, more tired, and nausea noted. She stayed in her room more after the vaccine because worried about giving/getting COVID to others. was talking on the phone at 11:30 PM on 1/26/21 to staff person about temperature of room. at 12:15 AM on 1/27/21 staff noted not breathing, started CPR and called EMS. When EMS arrived they stopped the code because she was too long deceased.",Yes,01/27/2021,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/22/2021,4.0,PHM,Fish oil Aspirin Calcium + D Lisinopryl 10 mg methimazole 5 mg colase 100 mg Hydrochlorathiazide 25 mg amlodipine 5 mg atenolol 25 mg trazadone 50 mg,none,"hypertension, hyperlipidemia, hyperthyroidism, thyroid nodules, constipation, osteopenia, insomnia, incontinence",,none,"['Death', 'Dyspnoea', 'Fatigue', 'Nausea', 'Respiratory arrest', 'Resuscitation', 'Sluggishness']",1,PFIZER\BIONTECH,IM 985505,NY,23.0,F,"Patient received her second dose of Moderna Vaccine at 17:00 and at 17:09 reported developing lightheadedness, itchy throat and subsequently became SOB and diaphoretic. Tachycardia noted at 120 bpm, and BP 148/80, RR 26. Medical First Response called and Dr. present administering Epi 0.3 ml sq to left lateral thigh at 17:12. Benadryl 50 mg given in R. Deltoid at 15:14. Pt. vital improved- 17:28: BP 130/82 and HR 90 RR 18. Transferred to ED. Noted to be diaphoretic, SOB, ashen skin and wheezing in the ED. Given Epi, Pepcid, Deacadron, Benadryl in ED and pt. responded well and discharged when hemodynamically stable. Discharge with Predisone and Benadryl. PCP f/u 2/4/2021",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,PVT,"Women 1 a day. Vit C+D, Allegra, Flonase, Azelestine, cont. DepoShot, Hydrozyzine, Effexor, Advair 250/50, Albuterol PRN, allergy shots.",Jan 4- Jan 7 Acute Asthma Exacerbation- unknown etiology,"Asthma, Allergic Rhinitus, endometriosis, depression and anxiety.",,"Environmental see below Allergies- Environmental- Dust, hay, weeds, cats, grass, trees, pollen. No food allergies. No product or medication allergies.","['Dizziness', 'Dyspnoea', 'Hyperhidrosis', 'Skin discolouration', 'Tachycardia', 'Throat irritation', 'Wheezing']",2,MODERNA,IM 985527,KY,96.0,M,"COVID-19 + ON 1-13-2021, TRANFERRED TO HOSPITAL ON 1-23-2021 DUE TO HYPONATREMIA",Not Reported,,Not Reported,Yes,,Not Reported,N,01/06/2021,01/23/2021,17.0,SEN,ALLOPURINOL CHOLECALCIFEROL DEBROX DOCUSATE SODIUM FLOMAX FLONASE GABAPENTIN KONSYL PACKET LASIX LORATIDINE MELATONIN MIRALAX SENNA,,NEUROPATHY HYPONATREMIA HTN BPH CKD ANEMIA GOUT,,ROCEPHIN,"['COVID-19', 'Full blood count', 'Hyponatraemia', 'Metabolic function test']",1,PFIZER\BIONTECH,IM 985528,,87.0,M,Admitted with COVID-19 infection 1/26/2021.,Not Reported,,Not Reported,Yes,,Not Reported,U,01/22/2021,01/26/2021,4.0,PVT,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 985635,TX,72.0,F,"awful burning in the chest/pain in her chest; horrible pressure and pain in her chest; nausea; felt woozy; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246), via an unspecified route of administration in the right arm on 13Jan2021 at 17:39 at a single dose in the hospital for covid-19 immunisation. Medical history included anxiety, seizures, and high cholesterol. She passed out last summer and they put her in the hospital from 31Aug2020 and ran all kinds of tests. In the end, they said she only had a few PVCs (premature ventricular contractions) and she doesn't need to see the doctor for a year. Mentioned she also has chronic bronchitis and this is related to having low platelet count and low immunity. All of these events predate treatment with Pfizer COVID 19 vaccine. Concomitant medication included amlodipine, atorvastatin for high cholesterol, clonazepam for seizures, escitalopram for anxiety, levothyroxine sodium for thyroid, and mirtazapine for sleep; all were ongoing. Stated that she had something weird happen after her injection about four hours after the shot. She received the first dose of the Pfizer COVID 19 vaccine on 13Jan2021 at 17:39 in the right arm. About three or four hours later on 13Jan2021, she was getting ready for bed and when she sat down and leaned over she had a god awful burning in her chest and nausea. She was going to take baking soda but when she sat up she had horrible pressure and pain in her chest and felt woozy so she sat on the floor and then the pain started to radiate through her arm and into her neck. The horrible pain and pressure in her chest felt like something was sitting on her chest and the bad pain in her chest was going into her arm and a little into her neck. She laid real still on the floor, and did a lot of praying, and then 20 minutes later it totally stopped. She got up slowly and finished getting ready for bed and was fine. She was just hoping they will still let her get the second shot. The whole event only lasted 20 minutes and when it was over it was completely gone. She did tell her husband when he came home. She was alone when this happened. The patient wanted to know if she can receive second dose of vaccine. She stated it almost felt like a heart attack. She was planning to get the second dose on 03Feb2021. Wanted to know if her effect will preclude her from getting the second dose of the vaccine. Outcome of the events was recovered on 13Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,PVT,AMLODIPINE; ATORVASTATIN; CLONAZEPAM; ESCITALOPRAM; LEVOTHYROXINE [LEVOTHYROXINE SODIUM]; MIRTAZAPINE,,Medical History/Concurrent Conditions: Anxiety; Chronic bronchitis; High cholesterol; Hospitalisation; Immune system disorder; Passed out (last summer); Platelet count low; Premature ventricular contractions; Seizures,,,"['Chest discomfort', 'Chest pain', 'Dizziness', 'Nausea', 'Neck pain', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 985656,CO,,M,"glaucoma; This is a spontaneous report from a contactable consumer (patient's wife) received via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 14Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that second dose was scheduled on 04Feb2021. It was reported that the patient has an appointment for glaucoma injection on 29Jan2021 in his eye. Reporter asked if okay to get it or reschedule his appointment. Outcome of the event was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,,,UNK,,,,,,['Glaucoma'],1,PFIZER\BIONTECH, 985658,,,U,"neuropathy in his lower leg from the knee down; Neuropathic pain; tingling; This is a spontaneous report from a contactable physician, the patient. This report was received via a Pfizer sales representative. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 23Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 06Jan2021, the patient experienced neuropathic pain in his leg below the knee. It felt like ""daggers in his foot"". On 06Jan2021, the patient also had neuropathy in his lower leg from the knee down that persisted. The patient received the second dose of BNT162B2 on 06Jan2020 and did not experience any worsening ""tingling"" after it. The clinical outcomes of the neuropathic pain and neuropathy and tingling were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the onset of neuropathy peripheral with neuropathic pain and tingling cannot be excluded due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/06/2021,14.0,UNK,,,,,,"['Neuralgia', 'Neuropathy peripheral', 'Pain in extremity', 'Paraesthesia']",1,PFIZER\BIONTECH, 985659,TN,,F,"high blood pressure/blood pressure was very high at 217/got it down a little to 200; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization. Medical history included heart surgery. The patient's concomitant medications were not reported. The patient received the first shot of the vaccine on 13Jan2021. On 14Jan2021, the patient experienced high blood pressure and was taken to the hospital. The patient would like to know if the COVID vaccine contain any substance that can trigger the blood pressure to go higher. The patient used to get iron bags for years injected and has not had any for a while and they said she needed some. The blood work showed that her iron was down. Patient's blood pressure has to be checked before giving it to the patient, and blood pressure was very high at 217. They waited a little bit for and got it down a little to 200 and gave her the iron (Jan2021). The patient was suggested to go over to a hospital. They were just concerned that it took a 12-hour process. The patient was then given different medications. Second shot of COVID vaccine is due in 3 weeks. She was just wondering would that have anything to do with her blood pressure going up and should she have the second dose. Her doctor did not think it had anything to do with it, but she said they only know so much. The patient was recovering from the event high blood pressure. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Cardiac operation,,,"['Blood iron decreased', 'Hypertension']",1,PFIZER\BIONTECH, 985661,,,F,"now her daughter is blowing up into a giant blueberry; she was really itchy all night long; up all night the first night; thought she had a rash; hives; This is a spontaneous report from a non-contactable consumer (parent). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing caller knows her daughter is allergic to antibiotics. The patient's concomitant medications were not reported. The reporter is upset right now, her daughter (patient) works in a Hospital, and received her vaccine (clarified as COVID vaccine) the day before yesterday (13Jan2021), her daughter was up all night the first night, she thought she had a rash (Jan2021), by yesterday afternoon, she was starting to get hives (Jan2021), they are getting worse, reporter will ask her to take pictures of the hives, but this is getting downplayed, she contacted whoever administered the vaccination, reporter thought she saw where there was an antibiotic involved, but it is not on the ingredient list. They asked if there was a little antibiotic in it. This is her grown child, reporter states she (the reporter) sent mean messages on social site to the company. Stated nothing bad better happen, she warned her daughter not to get it, reporter has a family history of bad reactions, and she said to not do it, but they say CDC recommendation, she has told everyone who is blood related to not get the vaccination, but per the CDC website, her daughter wouldn't listen, and she went in and was getting pressure from her workplace and not only that, her daughter is having this reaction downplayed, to the point where, they are thinking of convincing her to go back for shot #2, which is stupid, the reporter said don't do it, it's like Willa Wonka, she said don't do it, don't do it, and now her daughter is blowing up into a giant blueberry. When asked if she would be willing to go through a report, reporter said all she knows, her daughter has giant hives and they are getting worse, this is day 2, stated don't worry, Pfizer will know, this problem was reported to her daughter's doctor and she did report it, they told her, since it happened the next day, it was probably not that bad, but reporter said it started that very night, she said to her mother (reporter), that she was really itchy all night long (13Jan2021), and reporter asked if she had hives, and right caller said that, her daughter said yes, she didn't realize it was. Reporter wanted to know why she thinks there is some type of antibiotic involved, and she looked at ingredients, she looked and it didn't look like it, but something is telling the caller- she thinks her daughter knows what it was, which is why she is so sensitive, reporter knows her daughter is allergic to antibiotics. They asked if agent knew anything about these hives, what will happen. The doctor didn't even tell her daughter to take antihistamines, but reporter told her to take them immediately, they said it was nothing, and signed her up for shot 2, to stay on track, which reporter thinks is idiotic. Advised, for direct access to medical information on Pfizer products, they can visit web site. The reporter was provided with a phone number of #, option 3, and hours of operation of Monday through Sunday, 8AM to 11PM for COVID inquiries, prior to cold transfer onto the line, to wait for the next available agent. Reporter declined to provide any additional information and was cold transferred to Organization. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Allergy to antibiotic,,,"['Angioedema', 'Pruritus', 'Rash', 'Sleep disorder', 'Swelling']",UNK,PFIZER\BIONTECH, 985692,VA,64.0,F,Patient was found with AMS 1 day after receiving vaccine. Patient had pain at the injection site and fever of 103.,Not Reported,,Not Reported,Yes,,Not Reported,,01/19/2021,01/20/2021,1.0,PVT,,,,,,"['Injection site pain', 'Mental status changes', 'Pyrexia']",1,PFIZER\BIONTECH,IM 985715,FL,80.0,M,Patient received the vaccine on 12/29/20 and presented at the ER at the Hospital on 12/30/20 stating that he wasn't feeling well. It is stated that his health had declined over the past few weeks and currently on hospice. Visit was unremarkable. Patient stated that wanted to stop dialysis. Patient passed away on 01/02/2021.,Yes,01/02/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,PVT,metoprolol 25mg vitamin D3 1000IU furosemide 80mg Norvasc 5mg aspirin 81mg Renvela 800mg atorvastatin 20mg vitamin B12 1000mcg,high blood pressure dialysis GI bleed/ symptomatic anemia,,,no known allergies,"['Death', 'General physical health deterioration', 'Malaise']",1,MODERNA,IM 985761,OR,38.0,F,"10 days following the vaccine, I developed symptomatic palpitations at about 10am. Traveled to urgent care clinic (2pm) and experienced sudden onset SVT during that appointment (3pm). Was transported to ER, admitted to the hospital for observation, had another occurrence of SVT at midnight.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/10/2021,01/20/2021,10.0,PVT,Oral contraceptives Vit D,None,None,,None,"['Chest X-ray normal', 'Echocardiogram normal', 'Electrocardiogram ambulatory', 'Electrocardiogram normal', 'Laboratory test normal', 'Palpitations', 'Supraventricular tachycardia']",1,PFIZER\BIONTECH,IM 985773,MN,83.0,F,Resident was hospitalized on 1/17 after having multiple falls and change in condition. Resident returned to facility on 1/20- continued to be unable to ambulate as previous baseline. Son brought resident back to Hospital on 1/21 for further testing. Resident now being treated for Guillan Barre after having lumbar puncture and MRI. She has received IV IG treatments. Resident remains hospitalized.,Not Reported,,Not Reported,Yes,9.0,Yes,N,01/15/2021,01/17/2021,2.0,UNK,,,,,"PCN, caffeine","['Fall', 'Gait inability', 'Guillain-Barre syndrome', 'Immunoglobulin therapy', 'Lumbar puncture abnormal', 'Magnetic resonance imaging abnormal']",1,MODERNA,IM 985775,UT,39.0,F,"facial tingling in both cheeks like when your dentist numbs your cheek and it is waking up lasted 2-3 hours and decreased overnight. I am currently 29 weeks along G1 with due date of April 16, 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/28/2021,0.0,WRK,"prenatal vitamin, low dose aspirin, pepcid 20 mg twice a day",none,"PCOS, migraines, obese",redness and swelling at the injection site after flu shot and T-dap in 2020,"Penicillin, doxycycline, clindamycin- rash for all","['Exposure during pregnancy', 'Paraesthesia']",1,MODERNA,SYR 985779,UT,31.0,F,"Went into anaphylactic shock. Started feeling dizzy and light headed 15 mins after the vaccine was given. At 20 mins my throat felt tighter and it was making me cough trying to get air so they gave me 50 ml of benedryl into my right arm. I started to pass out and my breathing was labored so I was given my epipen and taken to the ER. While I was there I was monitored for 4 hours and given 2 more medications. One was a steroid, I?m unsure on the second.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,PUB,"Clonazepam, venlafaxine, lamotrigine",None,Chronic cough possibly due to asthma,,Bee stings,"['Anaphylactic shock', 'Cough', 'Dizziness', 'Dyspnoea', 'Presyncope', 'Throat tightness']",1,PFIZER\BIONTECH,IM 985814,OH,94.0,M,"started having generalized weakness on 1/21/21, fatigued., nausea/vomiting. went to doctor on 1/25/21 with complaint of sore throat, cough, and felt congested. Went to ER on 1/25/21 with complaints of increased shortness of breath, worsening nausea and vomiting. started on oxygen for sats of 87%. admitted on 1/25/21. On 1/26/21 needed intubated, CXR showed worsening consolidative change right lung at right hilar level. Echocardiogram showed ejection fraction 35-40%, left atrium is moderately dilated.",Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/21/2021,1.0,PUB,acetaminophen 500 mg amoxicillin 1 gm aspirin furosemids 40 mg glucosamine-chondroitin 1 tab cozaar 25 mg multivitamin potassium chloride 20 meq tamsulosin 0.4 mg furosemide 40 mg zofran 4 mg,started with a sore throat the day before vaccination,"anemia, BPH with obstruction, cervical neuritis, cervical spondylosis, cervicalgia, enlarged prostate, HLD, HTN, left sciatic nerve pain, low back pain, lumbar spinal stenosis, osteoarthritis, pacemaker, pancytopenia",,"morphine, oxycodone, hydrocodone, hydromorphone, coumadin","['Aspiration', 'Asthenia', 'Blood creatinine increased', 'Blood glucose normal', 'Blood potassium increased', 'Blood urea increased', 'Chest X-ray abnormal', 'Computerised tomogram thorax abnormal', 'Cough', 'Dyspnoea', 'Echocardiogram abnormal', 'Ejection fraction decreased', 'Emphysema', 'Endotracheal intubation', 'Fatigue', 'Haematocrit decreased', 'Haemoglobin decreased', 'Left atrial dilatation', 'Lung consolidation', 'Lung opacity', 'Nausea', 'Oropharyngeal pain', 'Pulmonary granuloma', 'Pulmonary hilum mass', 'Pulmonary mass', 'Red blood cell count decreased', 'Respiratory tract congestion', 'SARS-CoV-2 test negative', 'Vomiting', 'White blood cell count decreased']",1,MODERNA,IM 985841,WV,22.0,M,Received 2nd dose of Vaccine and developed numbness in his feet with tingling and shaking of his knees. Admitted for observation (initial concern for Guillain-Barre). Patient slept all night and discarged the following day with no symptoms.,Not Reported,,Not Reported,Yes,,Not Reported,Y,01/27/2021,01/27/2021,0.0,PVT,"Lisinopril, Omeprazole, Dicyclomine",,"GERD, Anxiety, Chronic Sinusitis",,Beestings,"['Blood creatine phosphokinase', 'Blood lactic acid', 'Full blood count', 'Hypoaesthesia', 'Metabolic function test', 'Paraesthesia', 'SARS-CoV-2 test', 'Tremor']",2,MODERNA,IM 985874,NM,76.0,M,Gillian Barre Syndrom,Not Reported,,Not Reported,Yes,3.0,Yes,N,01/21/2021,01/27/2021,6.0,PVT,,,Diabetes millitus,,,['Guillain-Barre syndrome'],1,MODERNA,IM 985933,,,F,"Died; Increased respirations (22 and labored at times); Pulse 105; 94% O2 on RA; Labored breathing at times; leukocytosis; elevated BUN; left lower lung congestion; elevated creatinine; Temperature of 102.0F; Redness on face; A spontaneous report was received from a nurse concerning a 92-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness on face, increased respirations, labored breathing at times, temperature of 102F, pulse of 105, 94 percent O2, leukocytosis, elevated BUN, left lower lung congestion, elevated creatinine, and death. The patient's medical history, as provided by the reporter, included dementia and reduced mobility. No relevant concomitant medications were reported. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 30 Dec 2020, the patient began to experience redness on her face, increased respirations (reported as 22 and labored at times), pulse of 105, and 94 percent oxygen saturation on room air. The patient had a fever of 102 degrees Fahrenheit. Laboratory tests revealed a negative influenza swab, elevated white blood cell count of 14.1, elevated BUN at 113, and creatinine 2.7. Chest x-ray showed mild, left lower lung infiltrate. On 31 Dec 2020, the patient went under hospice care per her family request.. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 01 Jan 2021, the cause of death was unknown.; Reporter's Comments: This case concerns a 92-year-old, female subject with medical history of dementia and reduced mobility, who experienced the serious unexpected events of death, respiratory rate increased, heart rate increased, oxygen saturation decreased, elevated BUN, elevated creatinine, left lung congestion and dyspnoea and the non-serious events of erythema and pyrexia. The events of respiratory rate increased, heart rate increased, oxygen saturation decreased, dyspnoea, erythema and pyrexia occurred 2 days after the first dose of the study medication administration, and the event of death occurred 4 days after the first dose of the study medication administration. Very limited information regarding the events is available at this time and no definite diagnosis or autopsy report have been provided. Additional information has been requested.; Reported Cause(s) of Death: Died",Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/30/2020,1.0,UNK,,,Medical History/Concurrent Conditions: Dementia; Walking disability,,,"['Blood creatinine increased', 'Blood urea increased', 'Chest X-ray abnormal', 'Death', 'Dyspnoea', 'Erythema', 'Influenza virus test negative', 'Leukocytosis', 'Lung infiltration', 'Pulmonary congestion', 'Pyrexia', 'Respiratory rate increased', 'White blood cell count increased']",1,MODERNA,OT 985947,TX,37.0,F,"pain on arm/body/body; nausea; brain fog; migraine; swollen arm; pain at injection site; could not move; fever; increase blood pressure; chest tightness; The Vaccine vail was not mixed with Sodium Chloride prior to administration; The Vaccine vail was not mixed with Sodium Chloride prior to administration; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (15Jan2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable Pharmacist. A 37-year-old female patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL0140, expiration date: Mar2021), via Intramuscular on left arm on 02Jan2021 at 18:00 at 0.3 mL, single for covid-19 immunisation. The relevant medical history was not reported. Concomitant medications were reported as none. The patient previously took Tylenol one hour prior to the vaccination on 02Jan2021 at 1 tablet by mouth. Patient complained of nausea, brain fog on 02Jan2021 at 06:20 pm. Pharmacist recommended to admit ER for safety and to monitor. Patient received the injection at 6pm. Patient was recommended by Pharmacist to admit ER for safety. Patient decided to admit ER at 10 pm. No other symptoms were reported from patient. The patient was admitted to hospital on 02Jan2021 and was discharged on 03Jan2021. While at the hospital, patient informed that she had fever, increased in blood pressure, and chest tightness on 03Jan2021 (reported as mid night). Patient admitted to hospital on 10 pm and was discharged the next day with ibuprofen/Tylenol/ zofran and continue to monitor for symptoms. After discharged, while at home, patient informed about migraine, swollen arm, pain at injection site and body that she could not move at 9:00 am on 04Jan2021. Patient informed that she admitted to hospital again about the pain on arm/body. The patient received 1 dose of 0.3ml and before it was possible that the vaccine was not mixed with sodium chloride prior to administration, an error due to mixture to communicate clearly adequately between our colleagues. Patient received the vaccine at 6 pm on 02Jan2021. After speaking with our colleague about 15 minutes ran to check on the patient if she was feeling okay. Patient complained feeling a bit nausea, brain fog, no other symptoms. Patient stated that she was okay. They stayed back at the store to keep track of patient to admit to ER after her shift at 10 pm. Patient informed she had fever, chest tightness, increase blood pressure at the hospital, then was discharged the next day with ibuprofen/tylenol/Zofran. The following day during at home patient complained at migraine, swollen arm, Pain at the injection site and could not move due to the pain. Patient decided to admit back to hospital for additional information about her pain. They contacted patient again after 3 days, patient informed. She was better and had returned to work on 13Jan2021. The outcome of the events was recovered on 11Jan2021. The pharmacist considered the events were related to suspect product Covid-19 by Pfizer.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported nausea, brain fog, pain on arm/body, and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/02/2021,01/02/2021,0.0,PHM,,,,,,"['Blood pressure increased', 'Chest discomfort', 'Feeling abnormal', 'Injection site pain', 'Migraine', 'Mobility decreased', 'Nausea', 'Pain', 'Peripheral swelling', 'Pyrexia']",1,PFIZER\BIONTECH,OT 985951,IL,55.0,F,"Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days. By Saturday, her symptoms began to improve. On Monday 1/25/21, the patient developed a petechial rash around the injection site and noticed sores on her gums and the patient went to OR. Evaluation at outside ED showed a platelet count of 2,000 with a normal H/H. Patient was transferred to our hospital for increased level of care, hematology consult and platelet transfusions. Significant hematology workup with a clinical picture thought to be consistent with ITP. Patient started on dexamethasone 40mg and received IVIG x 3 doses and platelet counts have started to improve",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/21/2021,01/21/2021,0.0,UNK,"Albuterol Inhalation, Trulicity Injection, Lexapro 20mg, glimepiride 4mg, hydrochlorothiazide 25mg, Basaglar insulin, lisinopril 40mg, lorazepam 0.5mg, metformin 1000mg",None,"Hypertension, Diabetes Mellitus, Arthritis",,Allergy/intolerance to ibuprofen noted,"['Fatigue', 'Headache', 'Immunoglobulin therapy', 'Injection site rash', 'Noninfective gingivitis', 'Petechiae', 'Platelet count decreased']",1,PFIZER\BIONTECH,IM 985960,MA,,U,"tested positive for Covid-19 (asymptomatic); tested positive for Covid-19 (asymptomatic); This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid-19 (asymptomatic) on 13Jan2021. The pharmacist wanted to know if a person who was administered with the first dose of the Covid-19 vaccine on administered on 04Jan2021 and on 13Jan2021 tested positive for Covid-19 (asymptomatic) and needs to quarantine can proceed with the second dose of the vaccine or if it's contraindicated. The pharmacist also wanted to know if it was okay to give the second dose as long as 90 days if a person with Covid-19 is deferred after recovering, and also asked when the second dose can be received if somebody did not recover fully from Covid. The outcome of the event was unknown. Information on the batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported ""tested positive for Covid-19"".",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/13/2021,9.0,UNK,,,,,,"['Asymptomatic COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 985967,OH,63.0,M,"tinnitus; loss of hearing on Left side; This is a spontaneous report from a contactable physician (patient himself). A 63-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via an unspecified route of administration on the left arm on 06Jan2021 at a single dose for COVID-19 immunization at hospital facility. Medical history included benign prostatic hyperplasia (BPH) and hypothyroidism. The patient had no known allergies and did not have COVID prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), tamsulosin hydrochloride (FLOMAX), and finasteride taken within two weeks of vaccination. The patient had no other vaccine in four weeks. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK8330) via intramuscular route on the left arm on 16Dec2020 at 6:15AM. The patient experienced tinnitus and loss of hearing on left side on 13Jan2021, 7 days post 2nd dose. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Prednisone taper was given as treatment for the events. The patient had not been tested for COVID post vaccination. The outcome of the events was unknown.; Sender's Comments: Based on the information provided, the possible contribution of suspect BNT162B2 to the events tinnitus and loss of hearing cannot be totally excluded given the time association. The detailed clinical course about these events would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,U,01/06/2021,01/13/2021,7.0,PVT,SYNTHROID; FLOMAX [TAMSULOSIN HYDROCHLORIDE]; FINASTERIDE,,Medical History/Concurrent Conditions: BPH; Hypothyroidism,,,"['Deafness', 'Tinnitus']",2,PFIZER\BIONTECH, 985974,,,M,"Atrial Fibrillation; his heart was racing and was something very unusual; This is a spontaneous report from a contactable consumer (patient himself). An 80-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient mentioned that he was a pretty healthy at 80 years old. He and his wife got vaccinated for the 1st shot last 05Jan2021. He experienced no side effects for a week. On 12Jan2021, he experienced his first ever episode of atrial fibrillation and said that his heart was racing and was something very unusual. He mentioned that his I-watch first notified him of this and he went to consult his doctor who confirmed this. He was prescribed with baby aspirin but had not taken it yet. Outcome of events were unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/12/2021,7.0,UNK,,,,,,"['Atrial fibrillation', 'Palpitations']",1,PFIZER\BIONTECH, 985979,NC,57.0,F,"fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected arm); numbness in hand (vaccine affected arm) with edema of hand; broke all the blood vessels in both eyes; O2 saturation's dropped to 86%; Headache within 1 hour; This is a spontaneous report from a contactable nurse. A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on arm right from 14Jan2021 12:00 to 14Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation. Medical history included End-Diastolic Heart Failure, osteopenia and arthritis. Concomitant medication included losartan, furosemide (LASIX [FUROSEMIDE]), metronidazole (FLAGYL [METRONIDAZOLE]) and omeprazole. The patient took his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), from 22Dec2020, 09:00 AM to 22Dec2020, 09:00 AM on Left arm (patients age: 57 years). The patient previously took tetracycline and erythromycin and had known allergies. On 14Jan2021, the patient had headache within 1 hour, then also on 14Jan2021, at 23:00 the patient also had fever 103.9F at 12 hours, constant coughing, O2 saturation's dropped to 86%; broke all the blood vessels in both eyes; severe body pain; numbness in hand (vaccine affected arm) with edema of hand. Outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events broken blood vessel in eye and oxygen saturation low. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,PVT,LOSARTAN; LASIX [FUROSEMIDE]; FLAGYL [METRONIDAZOLE]; OMEPRAZOLE,,Medical History/Concurrent Conditions: Arthritis; Diastolic heart failure; Osteopenia,,,"['Cough', 'Eye haemorrhage', 'Headache', 'Hypoaesthesia', 'Oedema peripheral', 'Oxygen saturation decreased', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 985981,,,F,"my blood pressure, it was up to 217; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 13Jan2021 at 12:00 PM at a single dose for COVID-19 immunization . The patient's medical history and concomitant medications were not reported. On 13Jan2021, the patient received the first shot then had no problems. On 14Jan2021, 24 hours afterwards, the patient had two doctors supposed to get her iron injections and they checked her blood pressure, it was up to 217, they got it down a little and finally gave the iron. They recommended the patient went over the ER and be checked. The patient spent a good 10 hours there having medications to get it down. Finally, it went down: 187/92 and everything fine there. The patient was given injection through the IV and finally got one that worked; got the lowest it would come. The patient came home on 15Jan2021 at 3:00 AM, went to bed then got up and her husband took her blood pressure: 127/65 and informed that it has not been taken since 8:00 AM. The patient was told by doctors that they did not think it was related to the COVID-19 vaccine. The outcome of the event was recovered on 15Jan2021. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/14/2021,1.0,UNK,,,,,,['Blood pressure increased'],1,PFIZER\BIONTECH, 985982,PA,76.0,F,"believed the heart rate might be a result of being nervous; Tightness of throat/throat tightness; Laboured breathing; Fast HR/high heart rate; This is a spontaneous report from a contactable nurse, reporting for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 03Jan2021 at a single dose for COVID-19 immunization. Medical history included sensitivity to pollen, sensitivity to narcotics and allergic reactions to perfume, all from unknown dates and unknown if ongoing. There were no concomitant medications. The patient previously received pneumonia vaccine and flu vaccine, both for immunization and experienced pain on the side. The patient also previously took cortisone to lower her immune system. It was reported that on 03Jan2021, the patient developed a slight reaction immediately after first dose of Pfizer Covid vaccine which included tightness of throat along with laboured breathing with fast HR/heart rate was high (she believed it was greater than 80 BPM; her heart rate is usually in the 60's) which resolved after a few minutes. The nurse was going to give her Benadryl but did not as her signs and symptoms were resolving. She was asking for recommendations/clarifications on whether she should get the second dose given her reactions. She never had that type of reaction before. She had had sensitivity to pollen and narcotics. She read that she should not receive the second dose given her reactions but was asking for clarification. She would like to get the second dose and bought an Epi pen. Throat tightness and high heart rate didn't last for more than two minutes maximum. She visited websites and was directed not to get the second dose. She wanted to be 100% certain in regards to whether or not she should receive the second dose. Stated tightness in throat wasn't really that bad. She felt throat tightness previously when smelling perfume. Stated it wasn't anything to be frightened about. She also stated some websites said it does not matter and some websites said not to get the second dose. Also wanted to know if having the Epi Pen would help. She added that she explained reaction to the physician who advised her to get an Epi Pen for the second COVID Vaccine dose. She only had allergic reactions to pollen and perfume. Got the vaccine for Pneumonia and Flu. Did not get adverse reactions, but stated she only had pain on the side. Confirmed she has no NDC/Lot/Exp for the Pneumonia vaccine and Flu vaccine. She also got Coronavirus three months prior to receiving the COVID vaccine. She clarified that she diagnosed herself and it was the weirdest thing. She took cortisone to lower her immune system. Received first dose of COVID Vaccine on 03Jan2021. She wa due for second COVID Vaccine on 26Jan2021. She stated she is a psychologist with specialty in mental health. She believed the heart rate might be a result of being nervous. When she is nervous her heart rate goes up. Tightness of throat made her concerned. When asked about the indication, she stated that her husband works and the right thing to do was to be protected. She read she should have stopped taking Ibuprofen 10 days prior to the COVID Vaccine. She was not taking Ibuprofen any longer. Has no NDC/Lot/Exp for Ibuprofen at time of call. Confirmed she did not use the Epi Pen after the first dose of COVID Vaccine. She bought it for the second dose. The nurse who administered COVID Vaccine to the patient suggested she take Benadryl. By that time, she was feeling better. She stated it was questionable for half an hour. The outcome of the event Tightness of throat/throat tightness and fast HR/high heart rate was recovered on 03Jan2021 while the outcome of all other events was unknown. Information on the batch/lot number has been requested.; Sender's Comments: The patient had medical history included sensitivity to pollen, sensitivity to narcotics and allergic reactions to perfume. The reported events were likely related to first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/03/2021,01/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Drug allergy; Perfume sensitivity; Pollen allergy,,,"['Dyspnoea', 'Heart rate increased', 'Immediate post-injection reaction', 'Throat tightness']",1,PFIZER\BIONTECH, 985988,NM,77.0,M,"He woke up could not walk; dizziness; lots of difficulty walking; This is a spontaneous report from a contactable consumer (patient's daughter) A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 13Jan2021 at 15:00 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included borderline diabetic. It was also informed that patient had a little bit of cognitive decline predating the vaccine and he didn't drive. Concomitant medications were not reported. On 14Jan2021 the patient woke up and could not walk. On the same day (14Jan2021) the patient also experienced dizziness and lots of difficulty walking. He was admitted to hospital on 14Jan2021. Reported the CT was clean, chest x ray was clean and blood work was fine. Patient was planning to receive the next dose of vaccine on 03Feb2021. At the time of the reporting the patient was recovering from dizziness and had not yet recovered from other reported events. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/13/2021,01/14/2021,1.0,MIL,,,Medical History/Concurrent Conditions: Cognitive impairment; Diabetic,,,"['Blood test normal', 'Chest X-ray normal', 'Computerised tomogram normal', 'Dizziness', 'Electrocardiogram', 'Gait disturbance', 'Gait inability']",1,PFIZER\BIONTECH, 985991,MI,28.0,F,"Right breast implant exploded and spread to her neck where she was having difficulty breathing/Right breast implant erupted. Silicone in breast implant spread into her neck where patient was having difficulty breathing; Right breast implant exploded and spread to her neck where she was having difficulty breathing/Right breast implant erupted. Silicone in breast implant spread into her neck where patient was having difficulty breathing; This is a spontaneous report from a contactable Physician. A 28-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), intramuscular on 13Jan2021 10:00 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. Vaccine location was right arm. No prior vaccinations within 4 weeks. Patient called stating she wasn't feeling well. She was in the resident lounge and all of a sudden, the right breast implant just popped. Silicone in her breast implant spread into her neck where patient was having difficulty breathing on 14Jan2021. The patient was hospitalized on 14Jan2021, with pain medication and will have to have the implants removed. They think it is vaccine related. Patient was waiting for general surgery. The outcome of right breast implant exploded was unknown. The outcome of difficulty breathing was not recovered. Information on the Lot/batch number has been requested.; Sender's Comments: The reported breast implant rupture and associated difficulty breathing were more likely due to breast implant surgery and the quality of implant, and unlikely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/13/2021,01/14/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Device breakage', 'Dyspnoea', 'Laboratory test', 'Malaise', 'X-ray']",UNK,PFIZER\BIONTECH,OT 985993,TX,34.0,F,"Previously G1P1, delivered normal healthy baby July 20, 2020. Second pregnancy conception 12/15/2020. First vaccine dose 12/22/2020. Vaginal bleeding started 1/2/2021 and tapered down 1/4/2021. Light bleeding continued 1/4/2021 - 1/18/2021. Second vaccine dose administered 1/12/2021. Bleeding increased from light/none to medium flow on 1/19/2021 - 1/22/2021. Home urine pregnancy tests positive x 2 on 1/22/2021. HCG 56 mIU/mL and progesterone 0.5 ng/mL on 1/22/2021. HCG 17 mIU/mL and progesterone <0.5 ng/mL on 1/25/2021. Bleeding decreased to light flow 1/22-1/25 and gone 1/26/2021. Dr. diagnosed as early pregnancy loss/miscarriage.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,01/02/2021,11.0,PVT,omega 3 fatty acids 1gm PO BID NP thyroid 60 mg PO QAM,None,Hypothyroidism,,"Egg ovalbumin, raw - rash/hives","['Abortion spontaneous', 'Exposure during pregnancy', 'Human chorionic gonadotropin decreased', 'Pregnancy test positive', 'Progesterone decreased', 'Vaginal haemorrhage']",1,PFIZER\BIONTECH,IM 985994,NY,78.0,F,"She has shrunk; weighs less. Maybe 154 pounds. She was 170; she got first dose of Pfizer COVID vaccine on Monday 04Jan2021/She will get the second dose on 01Feb2021; she got first dose of Pfizer COVID vaccine on Monday 04Jan2021/She will get the second dose on 01Feb2021; had congestion; Coughing; choking; body was more than hot it was burning/body turned very hot; could not sleep/two sleepless nights; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization, ciprofloxacin (CIPRO), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication and pirfenidone (ESBRIET), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication. Medical history included pulmonary fibrosis (diagnosed between 2007-2010), Lymphoma type B, blood pressure (abnormal), cholesterol (abnormal), vertigo, biopsy, tightening of legs and feet, drip (nasal) and pain. Concomitant medication included gabapentin for tightening of her legs and feet, diphenhydramine hydrochloride (BENADRYL) for drip (nasal) and meloxicam for pain. It was reported that the patient took the vaccine and had two sleepless nights on 05Jan2021, her body turned very hot but she have some conditions. Sleepless nights: they have been really rough nights. Scary. Coughing and choking. She thinks the vaccine kicked in and started beating the hell out of it. The patient clarified that she is having sleepless nights because of the coughing, choking, and burning and she feels that it is related to the vaccine kicking in. She slept last night, 14Jan2021. The cough is starting again today (as reported). She hopes it calms down. When she said her body was hot, like burning she was describing her sleepless nights. She is afraid. She is keeping in contact with her doctor. She figured she better call because more people are on this medication. The patient also experienced congestion on 06Jan2021. It was reported that the patient has shrunk and weighed less. Maybe 154 pounds. She was 170. The action taken for ciprofloxacin and pirfenidone was unknown. The outcome of the event congestion was not recovered, while unknown for the rest of the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,UNK,GABAPENTIN; BENADRYL; MELOXICAM; CIPRO [CIPROFLOXACIN]; ESBRIET,,Medical History/Concurrent Conditions: Biopsy; Blood cholesterol abnormal; Blood pressure abnormal; Lymphoma (Verbatim: Lymphoma type B); Muscle tightness; Nasal discharge; Pain; Pulmonary fibrosis (diagnosed between 2007-2010); Vertigo,,,"['Choking', 'Cough', 'Fear', 'Feeling hot', 'Insomnia', 'Respiratory tract congestion', 'Skin burning sensation', 'Weight decreased']",1,PFIZER\BIONTECH, 985999,NC,37.0,F,"Persistent shortness of breath; Chest pain; Runny nose; Dry cough; Dizzy; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-year-old female patient received the second dose of bnt162b2 (COVID-19 vaccine, brand: Pfizer) via an unspecified route of administration in right arm, on 07Jan2021 09:15 at a single dose for COVID-19 immunization in a hospital. Medical history included narcolepsy from an unknown date and unknown if ongoing and ongoing persistent shortness of breath from an unknown date. No known allergy. Concomitant medication included armodafinil, sertraline hydrochloride (ZOLOFT), and dextroamphetamine (DEXAMFETAMINE). The patient previously received the first dose of bnt162b2 on 21Dec2020 12:00 in right arm for COVID-19 immunization at age 37 years old. The patient had no COVID prior to vaccination. On 07Jan2021, the patient experienced shortness of breath, chest pain, runny nose, dry cough, dizzy. The patient had 2 ER visits and admission, and ongoing work up. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 1 day. The patient received albuterol and alprazolam (XANAX) as treatment. The patient underwent covid test post vaccination: Nasal swab on 11Jan2021 and on 12Jan2021 with both with result negative. The patient had not recovered from the events. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events shortness of breath, chest pain, runny nose, dry cough and dizzy. The patient's underlying ongoing shortness of breath and psychiatric disorder treated by sertraline may also be contributory. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,ARMODAFINIL; ZOLOFT; DEXTROAMPHETAMINE [DEXAMFETAMINE],Shortness of breath,Medical History/Concurrent Conditions: Narcolepsy,,,"['Chest pain', 'Condition aggravated', 'Cough', 'Dizziness', 'Dyspnoea', 'Rhinorrhoea', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH, 986001,NY,58.0,F,"Headache; Chills; not feeling well; tingling all over her arms, face and legs; severe fast heartbeat; Dizziness; difficulty breathing; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0142, expiry: Mar2021), via an unspecified route of administration on 03Jan2021 at a single dose for covid-19 immunization. The patient has no medical history and no concomitant medications as the patient reported she was healthy. The patient experienced severe reactions, she was in the hospital twice. On 10Jan2021, the patient experienced difficulty breathing, severe fast heartbeat and dizziness. On 13Jan2021, patient had headache, chills, not feeling well, and tingling all over her arms, face and legs. The patient further stated that a week after getting the vaccine, last Sunday, she had a severe reaction and was hospitalized twice due to the events. Exactly one week after receiving the vaccine, on Sunday 10Jan2021, patient ended up in an ambulance due to dizziness, fast heart rate, and difficulty breathing which all started on 10Jan2021. She confirms that she was admitted to the hospital that day, and she was discharged the next day, on 11Jan2021 in the afternoon. On 13Jan2021, in the afternoon, the other symptoms of headache, chills, not feeling well, and tingling all over her arms, face and legs, started. Patient went back to a different hospital, to the emergency room, on Wednesday 13Jan2021, but was not admitted at that time. Patient mentioned the difficulty breathing was okay, but she does not want to say it was 100% better because she was still having a little bit of difficulty. Caller states that the dizziness and fast heart rate are still pretty serious. It was reported that the patient was hospitalized for the event fast heart rate from 10Jan2021 to 15Jan2021, and chills, not feeling well, and tingling all over her arms, face and legs on unspecified date. Patient was due to get the second dose on 24Jan2021, and she does not know if she should because she had side effects to the first dose. Patient seen several doctors and she had a cardiologist that was monitoring her, and she has had a stress test and labs and those are all normal. patient confirms that the product was no specifically prescribed to her, but it was given via workplace policy as she works for a hospital. The outcome of the events difficulty breathing was recovering and not recovered for all the other events. No follow-up attempts are possible; information about batch number has been obtained.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/03/2021,01/10/2021,7.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No,,,"['Cardiac stress test normal', 'Chills', 'Dizziness', 'Dyspnoea', 'Headache', 'Heart rate increased', 'Laboratory test', 'Malaise', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 986006,WA,,M,"His reaction was swollen lymph nodes nearly blocking his airway; His reaction was swollen lymph nodes nearly blocking his airway; This is a spontaneous report from a contactable consumer (pharmacy intern) reported a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reaction was swollen lymph nodes nearly blocking his airway. He did not seek treatment and it did subside. It was reported that a patient received the first dose of the Pfizer Covid vaccine and it seems like there was swelling of the lymph nodes in the neck to the point where it started to block the airway. Patient had no swelling of the tongue or shortness of breath, but there was swelling that was starting to block the airway due to that. Patient had no anaphylaxis reaction. They are wondering if he should get the second vaccine. Knows there is extensive guidance on the CDC and on Pfizer website about not to get the second dose if anaphylaxis occurs, but they don't consider this anaphylaxis reaction in this case. Should patient get it or not or if he can get it to go to a facility where he can be monitored and have Epipen on stand by if needed. They know normally it would be treated with steroids, but they tend to counter interact with the vaccine which can affect the immune system. Outcome of the events was recovering. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Lymphadenopathy', 'Obstructive airways disorder']",1,PFIZER\BIONTECH, 986013,TX,80.0,M,"heart attack; chest pressure; hardly slept; This is a spontaneous report from a contactable consumer (patient's wife). An 80-year-old male patient (reported also as 81-years-old, to be clarified) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL3246), via an unspecified route of administration, on 13Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 80-years-old. Medical history included ongoing emphysema and ongoing diabetes (caller has been diagnosed for 35 years for both conditions), heart was damaged because of the diabetes, and a history of bypass 4 years ago however he hasn't had any issues with chest pressure since before the bypass. Concomitant medications were none. On 15Jan2021 at 1:am he developed pressure in the chest which ultimately resolved. This trouble last night, lasted over 1 hour. He couldn't get back to bed. He had to sleep sitting up on the sofa. That was the only way he was comfortable. Her husband has hardly slept. She was seeing how he was doing. He said he was okay sitting. The pressure on his chest would go away while he was sitting, but laying down it would come back. This morning (15Jan2021) she made him check when he woke up at 8 o'clock. She made him lay down, and he said it was gone after sitting the whole night. He is well now. He is feeling fine. He didn't even ask for help getting on his clothes. He got the vaccine because of his age and because of underlying conditions. Her husband has done very well this year. He even has underlying conditions. He has had Emphysema for 35 years, but it hasn't been bothering him. He has also had diabetes for 35 years. The reporter spoke to her husband's hcp (nurse) who said it could have a heart attack and for him to go to hospital if it reoccurs. She did speak with a nurse with his primary doctor, and she said the pressure in his chest for 1 hour could have been a heart attack. That if it occurs again to give him the nitroglycerin. She told the nurse it wasn't pain. The reporter stated chest pressure could have been a heart attack. He is scheduled to get the 2nd dose on 21Jan2021. The reporter was wondering if her husband can have the second dose given it has potassium in it (given he has bypass history). The reporter is afraid the vaccine is not safe, and they may not go for the second vaccine. She wants more information if it is safe. The events recovered on 15Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/15/2021,2.0,UNK,,Diabetes (caller has been diagnosed for 35 years.); Emphysema (caller has been diagnosed for 35 years. it hasn't been bothering him); Heart disorder (heart was damaged because of the diabetes),"Medical History/Concurrent Conditions: Bypass surgery (heart bypass 4 years ago, hasn't had any issues with chest pressure since before the bypass.)",,,"['Chest discomfort', 'Sleep disorder']",UNK,PFIZER\BIONTECH, 986015,,36.0,F,"tired; sore; thought that she would pass out; dizziness/felt dizzy; weakness/felt very weak; hard for her to talk/was having a hard time talking, like she had to put effort into talking; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Expiry Date: 31Mar2021, lot# EJ1685), intramuscularly in left arm on 31Dec2020 at 0.3 mL, single for COVID Prevention. Medical history included ongoing Hypertension/high blood pressure (Diagnosed about 2 years ago). Concomitant medication included ongoing ascorbic acid (VITAMIN C) and just some other vitamins but she does not think that is relevant. She had no other vaccines on the same day as the COVID vaccine. The patient experienced dizziness/felt dizzy, weakness/felt very weak, hard for her to talk/was having a hard time talking, like she had to put effort into talking, thought that she would pass out, all on 31Dec2020 with outcome of recovered on 31Dec2020, tired and sore on 02Jan2021 with outcome of recovered on 04Jan2021. The patient got the vaccine on 31Dec2020, and is scheduled to receive the 2nd dose next week and within a couple minutes after getting the vaccine, like less than 5 minutes later, she felt dizzy and very weak, and thought that she would pass out, and she was having a hard time talking, like she had to put effort into talking. After like an hour, she felt better. From then on, she had no side effects besides just being tired and sore, but she had no fever or anything like that. She does have hypertension in her history, but she hasn't been taking her pill because her BP has been stable. She felt like when she took the Pfizer Vaccine, some people can feel their BP shooting up, like it felt like a sensation in the back of head that her BP went up, but she did not think it was her BP because she has not needed to take her pill because her BP has been good. She did not take her BP, so she doesn't know what her BP was at the time. It was a pressure in the back of her like how she feels if her blood pressure is elevated. Investigation Assessment: No. Relatedness of drug to all the events was related per source of assessment: primary source reporter, method of assessment: global introspection.; Sender's Comments: Based on the compatible time association, the event depressed level of consciousness is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,UNK,VITAMIN C [ASCORBIC ACID],Hypertension (Diagnosed about 2 years ago),,,,"['Asthenia', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Pain', 'Speech disorder']",1,PFIZER\BIONTECH,OT 986016,,52.0,M,"trouble breathing; severe body aches; fevers and chills; extreme fatigue; headaches; passed out/ when trying to return to bed, passed out a second time; This is a spontaneous report from a non-contactable physician. A 52-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 07:30 at a single dose for COVID-19 immunization at the workplace clinic. The patient's medical history was not reported. Patient has no known allergies. Concomitant medication included venlafaxine hydrochloride (EFFEXOR). Patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date. On 15Jan2021 04:00, patient had severe body aches, followed very quickly by fevers and chills. At 4:45am started to have trouble breathing. Patient was concerned about respiratory symptoms, and woke his spouse, then stood up to try and breathe better, took a couple steps, and passed out. When the patient woke, when trying to return to bed, passed out a second time. Over the next few hours respiratory symptoms improved. Remainder of day characterized by extreme fatigue, body aches and headaches. Patient had an unspecified over the counter anti-inflammatory medication. The patient has a negative COVID 19 test via a nasal swab on an unknown date. Patient was recovering from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported passed out and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/15/2021,1.0,WRK,EFFEXOR,,,,,"['Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Loss of consciousness', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH, 986036,,37.0,F,"stroke; unresponsive; unable to move one side of her body; fell down the stairs; fever; felt groggy; This is a spontaneous report from a contactable consumer and a non-contactable consumer (patient's sister). A 37-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for an covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was an oncology nurse practitioner working received the Pfizer BioNtech vaccine on Thursday 14Jan2021. On Friday 15Jan2021, the patient visited her family members and told them she had a fever and felt groggy. She went to sleep around 8pm-9pm that evening (15Jan2021). Around 2am-3am in the morning Saturday 16Jan2021, the patient fell down the stairs and her family member found her - unresponsive and unable to move one side of her body. Her family member moved her to the couch. Around 7am-7:30am, the patient was still unresponsive and unable to move one side of her body. Her family dialed an ambulance took her to an hospital. At present - her family reported that the healthcare professional they spoke to said the patient had a stroke. She had received multiple scans (MRI, brain scan) in the hospital and was awaiting a Neuro consult. It was unknown if treatment received. The outcome of events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/14/2021,01/15/2021,1.0,UNK,,,,,,"['Cerebrovascular accident', 'Fall', 'Hemiplegia', 'Magnetic resonance imaging', 'Pyrexia', 'Scan brain', 'Somnolence', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH, 986039,LA,45.0,F,"severe muscle weakness; tremors all over the body; fatigue; headache; This is a spontaneous report from a contactable Other HCP reporting for herself. A 45-year-old female patient who was not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: WHO142), via an unspecified route of administration on 05Jan2021 11:30 at single dose in Left arm at the hospital for COVID-19 immunisation. Medical history included Wolff-Parkinson-White (WPW) syndrome from an unknown date. There were no known allergies. Concomitant medication included Multi Vitamin in two weeks. The patient did not receive other vaccine in four weeks. The patient had a mild headache within 2 hours on 05Jan2021. She started next day with headache and fatigue, on 06Jan2021. 3 days later (on 08Jan2021) severe muscle weakness and tremors all over the body. The adverse events (AEs) were resulted in Emergency room/department or urgent care, Hospitalization, the patient was hospitalized for AEs for 5 days. This was day 11 and she was still having the systems. She was released and now seeing a Nuero at (facility name) for additional treatment. The patient underwent lab tests and procedures which included COVID test type post vaccination=Nasal Swab: negative on 09Jan2021. The patient was not recovered from reported AEs.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events headache, fatigue, muscle weakness and tremor. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,,,Medical History/Concurrent Conditions: WPW syndrome,,,"['Fatigue', 'Headache', 'Muscular weakness', 'SARS-CoV-2 test negative', 'Tremor']",1,PFIZER\BIONTECH, 986044,IL,59.0,F,"Short of breath; Fluish symptoms; Fatigue; This is a spontaneous report from a contactable nurse. A 59-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1283, expiry date: Apr2021), via an unspecified route of administration on the right upper arm, from 08Jan2021 at 11:30, at a single dose for Covid-19 immunization and progesterone at 700 mg, daily (takes 300mg in the morning and 400mg and night) and then 200 mg (yesterday took 200 mg and today she took 200 mg), at unspecified route of administration, from an unspecified dates, for perinatal menopause symptoms. Medical history included allergic reaction to Penicillin, ongoing borderline high blood pressure, sleep apnea, perinatal menopause symptoms, and allergic reaction also with Sulfa drugs, it is hives and wheals with Sulfa drugs and overweight. The patient previously took prochlorperazine maleate (COMPAZINE) and experienced anaphylactic reaction, Diavan and experienced angioedema and allergic reaction, and first dose of bnt162b2 (lot number is EJ1685 with expiration Mar2021) on the right arm, on 18Dec2020 for Covid-19 immunization. The patient was calling about Pfizer COVID vaccine number 2. She knows she could go on the website but she also had a question she would like to see if she could be answered. She said she took the COVID vaccine 2 on 08Jan2021, Friday, and on 10Jan2021, Sunday she noticed she couldn't breath after taking her Progesterone. She takes Progesterone for perinatal menopause symptoms and she really needs it. She noticed about 20-25 minutes after taking her progesterone that she was short of breath and this has continued if not increased. It is not going away since then and she is wondering if there is any end in site. She went to a physician that is very knowledgeable and he said it is triggering an inflammatory response but she is really short of breath she is walking around with a O2 sat monitor on. She doesn't know if there is any end in site. She does not want to have to go in the hospital. Mainly after she takes her progesterone she is short of breath and she has gone down on her dosage a lot and she still having shortness of breath. She took the progesterone and 25 minutes later she became short of breath. The reaction has increased since it started on Sunday evening, 10Jan2021. She is noticing, she is still taking it and it has a long half life but even with dropping the dose a lot even with that it has stayed the same or gotten worse. She says she took her Progesterone on Saturday as she normally would. But Sunday morning when she took her 300 mg in the morning about 20 minutes or 25 minutes after she was very short of breath like she can't get a whole breath of air. She has reduced the dose she is taking now. Yesterday she took 200 mg and today she took 200 mg. She has been on it for 3 years and she has never had shortness of breath. She has never had shortness of breath before even though she is overweight she has not had shortness of breath unless she is running or some sort of exertion this is totally new. She said her initial side effects the fluish symptoms and fatigue began Friday evening on 08Jan2021 and had resolved completely on Saturday, 09Jan2021. Outcome of short of breath was reported as worsened (not recovered). The action taken for progesterone was dose reduced.; Sender's Comments: The event short of breath is more likely due to progesterone based on more close temporal relationship. However, a possible contributory role of BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,,Borderline hypertension,Medical History/Concurrent Conditions: Hives (it is hives and wheals with Sulfa drugs); Overweight; Penicillin allergy; Perimenopause; Sleep apnea; Sulfonamide allergy (it is hives and wheals with Sulfa drugs); Wheals (with the Sulfa drugs it is hives and wheals),,,"['Drug interaction', 'Dyspnoea', 'Fatigue', 'Inflammation', 'Influenza like illness']",2,PFIZER\BIONTECH, 986055,NJ,56.0,F,"close to passing out; felt ""heat waves"" throughout my body; tingling; palpitations; My BP was taken and it was 166/86 (my normal BP is usually 100/60).; This is a spontaneous report from a contactable Physician (the patient). A 56-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm, second dose, on 15Jan2021 14:30 at SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism and gastrooesophageal reflux disease, both from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID), esomeprazole magnesium (NEXIUM), estradiol, norethisterone acetate (AMABELZ), estradiol, levonorgestrel (CLIMARA PRO). Patient previously received the first dose of BNT162B2 in left arm, on 24Dec2020 08:15 AM. No other vaccine in four weeks. Vaccination Facility type: Hospital. No COVID prior vaccination. COVID was not tested post vaccination. No Known allergies. On 15Jan2021 about 5 minutes after the vaccination the patient experienced close to passing out, felt ""heat waves"" throughout my body, tingling, palpitations, blood pressure (BP) was taken and it was 166/86 (her normal BP is usually 100/60). No treatment was given. The symptoms slowly resolved over the next 45 minutes, with BP returning back to normal. Information on Lot/Batch has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported ""close to passing out"". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,PVT,SYNTHROID; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; AMABELZ; CLIMARA PRO,,Medical History/Concurrent Conditions: GERD; Hypothyroidism,,,"['Blood pressure increased', 'Dizziness', 'Feeling hot', 'Palpitations', 'Paraesthesia']",2,PFIZER\BIONTECH, 986063,UT,83.0,F,Resident was vaccinated on 1/13/21. Resident passed away on 1/16/21,Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/16/2021,4.0,SEN,"Cholestyramine, Duloxetine, Fiber, Haloperidol, Hyoscyamine, Lisinopril, Lorazepam, Metoprolol, Morphine, Nystatin powder, Pepto Bismol, Seroquel, Spiriva, Symbicort, Tramadol, Tylenol, Vistaril, Zolpidem","COPD, CHF, Major Depressive Disorder, Anxiety, Respiratory Failure, Insomnia, OsteoArthritis, Hypertension, Irritable Bowel Syndrome, Atrial Fibrillation, COVID recovered",Resident was a Hospice Patient as of: 11/17/2020,,No Known Allergies,['Death'],1,PFIZER\BIONTECH,IM 986079,TX,32.0,F,"Severe Headache/Migraine lasting for over 2 weeks; Severe Headache/Migraine lasting for over 2 weeks; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 30Dec2020 10:00 at a single dose on left arm for COVID-19 immunization. Medical history included spinal stenosis and allergies to cephalosporin. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior to vaccination. Concomitant medication included gabapentin. On 30Dec2020 19:00, the patient experienced severe headache/migraine which lasted for over 2 weeks, required prescription medication to make them bearable but even then, they didn't go away and were very bad. The patient spent the good part of two weeks in bed or at least not doing her regular level of activity. She went to Urgent Care twice and to the Emergency Room once. The patient was given prescription medication and IV pain medication as treatment for the events. The patient underwent lab tests and procedures which included nasal swab test (COVID-19 virus test) on 11Jan2021: negative result; and the same test on 14Jan2021 with negative result. The patient was recovering from the events. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,GABAPENTIN,,Medical History/Concurrent Conditions: Drug allergy; Spinal stenosis,,,"['Bedridden', 'Headache', 'Migraine', 'SARS-CoV-2 test negative', 'Viral test negative']",1,PFIZER\BIONTECH, 986085,VA,58.0,M,"Acute Unilateral Sensorineural Hearing Loss; This is a spontaneous report from a contactable physician. A 58-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular in left arm on 11Jan2021 at a single dose for COVID-19 immunization. Medical history included hyperlipidemia. The patient had no known allergies and was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included rosuvastatin calcium (CRESTOR). The patient previously received the first dose of bnt162b2 on an unknown date for COVID-19 immunization. The patient experienced acute unilateral sensorineural hearing loss on 17Jan2021 07:00 with outcome of not recovered. The event caused physician office visit. Therapeutic measures were taken as a result of acute unilateral sensorineural hearing loss that included prednisone. The patient was not tested with COVID-19 post vaccination.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, there is a reasonable possibility that the event acute unilateral sensorineural hearing loss is related to suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/17/2021,6.0,PVT,CRESTOR,,Medical History/Concurrent Conditions: Hyperlipidemia,,,['Deafness neurosensory'],2,PFIZER\BIONTECH,OT 986092,NM,39.0,F,"the right side swelling, swelling underneath armpit, swelling of collarbone and neck; This is a spontaneous report from a contactable Nurse reporting for herself. A 39-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL0142) vaccine, intramuscular on 12Jan2021 15:30 at single dose for Covid-19 immunisation. Medical history included deep vein thrombosis, provoked DVT, and moderate asthma . There were no concomitant medications. The patient received the first dose of BNT162B2 vaccine on 23Dec2020. The patient experienced right side swelling on 12Jan2021 some hours after injection. On 13Jan2021 swelling underneath armpit was significant, swelling of collarbone and neck was also present. The reported event was considered Important Medical event. The outcome of the event was recovering. The event was treated with Round the clock Ice pack. Antihistamine and NSAIDs. Followup information has been requested. Lot number already provided.; Sender's Comments: Based on the compatible temporal association, a contributory role of suspect vaccine BNT162B2 in the development of ""the right side swelling, swelling underneath armpit, swelling of collarbone and neck"" cannot be excluded. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Asthma (Moderate asthma); DVT (Provoked DVT),,,"['Injection site swelling', 'Oedema peripheral', 'Swelling']",2,PFIZER\BIONTECH,OT 986093,AR,48.0,M,"Started breaking out in hives that within 30 mins covered 80-90% of my body.; This is a spontaneous report from a contactable other health care professional (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1686 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 08Jan2021 15:00 at single dose for covid-19 immunisation. There was no medical history. The patient's concomitant medication included venlafaxine at 75 mg, 2x/day and unspecified medication. It was reported that the patient received the shot on Friday 08Jan2021 and no issue until Wednesday morning 13Jan2021 10:00, the patient started breaking out in hives that within 30 minutes covered 80-90% of my body. This resulted for the patient to visit physician office. The patient was treated with Steroid shot and pills, OTC Benadryl, and Pepcid. The outcome of the event was recovering. The patient was tested for Covid post vaccination on 14Jan2021 of Nasal swab and the result was negative.; Sender's Comments: Based on the available information, a causal relationship between the event urticaria and suspected vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/13/2021,5.0,PVT,VENLAFAXINE,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['SARS-CoV-2 test negative', 'Urticaria']",1,PFIZER\BIONTECH, 986096,,,F,"felt light headed and ""off""; felt light headed and ""off""; I felt worse/ doesn't feel good; Chest is very sore like I have been sick; Chest is very sore like I have been sick; Dry cough; Tired; shortness of breath; a great heaviness on her chest; This is a spontaneous report from contactable consumers. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included allergic to gluten. The patient's concomitant medications were not reported. The patient felt light headed and ""off"" on an unspecified date after the shot. As the day progressed, patient felt worse. Last night, on 14Jan2021, she had shortness of breath and a great heaviness on her chest. Like she was struggling to breathe. Got through the night with Benadryl. Saw her PCP today and her lungs were clear and PCP gave her a steroid shot. Patient started feeling better after that. But she still feels off. On an unknown date, chest was very sore like she had been sick. She had dry cough, was tired and her breathing thing comes and goes. She doesn't feel good. But she was not in hospital. Last night was scary according to the patient. Therapeutic measures were taken as a result of shortness of breath and a great heaviness on her chest which includes Benadryl and steroid shot. The outcome of shortness of breath was recovering, while for the rest of the events was unknown. Events took place after use of product. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,01/14/2021,,UNK,,,Medical History/Concurrent Conditions: Gluten sensitivity,,,"['Chest discomfort', 'Chest pain', 'Cough', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Fear', 'Feeling abnormal']",UNK,PFIZER\BIONTECH, 986097,TX,53.0,F,"she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tighten, and congestion; back was hurting; she had lost her taste and smell; she had lost her taste and smell; feeling her chest tighten, and congestion; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; allergy symptoms; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer (patient) reported that a 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration on 29Dec2020 at a single dose on left arm for COVID-19 immunization as COVID-19 prevention. Medical history included ongoing asthma diagnosed more than three years ago. The patient's concomitant medications were not reported. She had no other vaccines on the same day as her COVID vaccine. The patient had the first dose of the Pfizer COVID vaccine on 29Dec2020, and since then she has contracted COVID, and tested positive for it on 07Jan2021 with symptoms. She asked if she still can get the second shot on the 21st day following her first dose. When she got the vaccine, she was fine, just had a sore arm. A couple days before 07Jan2021, she developed allergy symptoms, and so on the 7th (07Jan2021), she went to get tested, and it was positive. She was 235 pounds, but since getting COVID on Jan2021, she is now 224 pounds. She reported that she started to have allergy like symptoms on maybe 05Jan2021, and on the 7th she went to get tested for COVID, because she had started feeling her chest tighten, and congestion, and her back was hurting, and she has a history of asthma, so she wanted to be seen. She confirmed that on 07Jan2021, she had a Rapid test for COVID, and the results came back the same day, as Positive. She was told that she should also have a 48-hour test, so she had that performed as well, and that one also came back positive, but she knew it would, because by then she had lost her taste and smell. The patient is scheduled for her 2nd dose 19Jan2021. She was wanting to know if she can still get the 2nd dose. She was told she needed to wait 30 days from her positive diagnosis before she could get the 2nd dose. She added that she will still be in isolation when her 2nd dose is due. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/05/2021,7.0,UNK,,Asthma (diagnosed more than three years ago.),,,,"['Ageusia', 'Allergic respiratory symptom', 'Anosmia', 'Back pain', 'COVID-19', 'Chest discomfort', 'Pain in extremity', 'Respiratory tract congestion', 'SARS-CoV-2 test positive', 'Weight decreased']",1,PFIZER\BIONTECH, 986098,PA,,U,"syncope; Dizziness; vertigo; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received both 1st and 2nd doses of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient had received two of the COVID vaccine and would like to report about a possible side effect. Three days after each shot the patient had an episode of dizziness with vertigo and syncope. The patient was not sure if this was related to the vaccine but since the patient had not had this before and wanted to report. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Dizziness', 'Syncope', 'Vertigo']",2,PFIZER\BIONTECH, 986100,LA,71.0,M,"Raspy voice in the morning; The right side of his mouth is droopy. The droopiness is not excessive, but it is odd.; Right eyelid puffiness/ on the right side of patient's face, the eyelid was puffy; Right eye full of fluid/Under that eyelid is full of fluid; Can't hardly see out of right eye due to swelling; This is a spontaneous report from a contactable consumer. A 71-year-old male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3299) via an unspecified route of administration on the left arm on 13Jan2021 14:00 at a single dose for COVID-19 immunization at a clinic/ used empty offices. Medical history included being diabetic, had heart attacks and blood clots on unspecified dates. It was confirmed that all of this occurred years ago prior to COVID-19 vaccination. The patient had no relevant family medical history and no relevant tests. The patient takes a number of medications (unspecified). The patient previously received Flu shot at least six weeks ago in Nov2020 and had no adverse events. The patient had no additional vaccines administered on the same date as BNT162B2. The reporter and her husband (patient) got their shots on Wednesday afternoon. That morning, on 15Jan2021 at 08:00, on the right side of patient's face, the eyelid was puffy/ right eyelid puffiness. He can hardly see out of it. He can see. Under that eyelid was full of fluid/ right eye full of fluid. The right side of his mouth was droopy. The droopiness was not excessive, but it was odd. The reporter also stated that the ""patient had a raspy voice in the morning anyways."" The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/15/2021,2.0,OTH,,,Medical History/Concurrent Conditions: Clot blood; Diabetic (Takes a number of medications); Heart attack,,,"['Dysphonia', 'Facial paralysis', 'Periorbital swelling', 'Swelling of eyelid']",UNK,PFIZER\BIONTECH, 986101,NJ,,M,"he has a sinus infection and took an antibiotic (Augmentin); tested positive; tested positive; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable other healthcare professional (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he received the first dose of COVID-19 vaccine last 09Jan2021 and was going to receive the second dose on 30Jan2021. He was being tested in their facility twice a week for COVID-19. He mentioned that for those two consecutive tests, he said he was positive last Tuesday and was negative on Thursday. However, this Friday 15Jan2021, the patient was tested positive and had no symptoms. He asked if he can have the second dose of the vaccine as a booster shot since he was tested positive. He mentioned that he also had a sinus infection and took an antibiotic (Augmentin). Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 09Jan2021, and COVID-19 test positive on 15Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use. The reported a sinus infection was more likely an intercurrent disease, and less likely causally related to the first dose of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/15/2021,6.0,UNK,,,,,,"['SARS-CoV-2 test positive', 'Sinusitis']",1,PFIZER\BIONTECH, 986102,NJ,,M,"eye problem before, did get worse after 1st shot; eye problem before, did get worse after 1st shot; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included eye problem, and cataract surgery. The patient's concomitant medications were not reported. It was reported that on 01Feb2021, a small eye surgery was scheduled to remove an eye film, from a post cataract surgery result. Patient had first vaccine. It was reported that the patient had eye problem before, and it did get worse after the first shot on an unspecified date, and so surgery scheduled. The second dose of vaccine was scheduled prior to surgery. The clinic wants to have him get Covid test prior to surgery and wants to know if Covid test will provide a positive result just because of the vaccine. The patient does not think the eye problem was result of vaccine but will fax as possible worsening of condition after shot. Outcome of event was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Cataract operation; Eye disorder (Had eye problem before),,,"['Condition aggravated', 'Eye disorder']",1,PFIZER\BIONTECH, 986104,GA,29.0,F,"raspy throat; red ears; a temperature; Headache; lip swelling; tongue swelling; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration on the left arm, on 14Jan2021 at 05:15, at a single dose for Covid-19 immunization. Medical history included asthma and uses an inhaler, glaucoma, nonsustained ventricular tachycardia for which she takes no medication. When she was a baby she had a reaction to the pertussis vaccine, she thought it was just a rash. Concomitant medications included topiramate (TOPAMAX) and bupropion hydrochloride (WELLBUTRIN). On 14Jan2021, the patient had a reaction after getting the vaccine. She reported that she had lip and tongue swelling. On the day of the report she still has the lip swelling. On 15Jan2021, the patient also had a raspy throat, red ears, a temperature, and headache. The center where she got the vaccine gave her diphenhydramine hcl (BENADRYL) through injection and the swelling went down. She noted she can breath, that has been complete fine. She explained that the lip and tongue swelling had gone completely down last night after the diphenhydramine hcl, but the lip swelling has come back as she has not taken any diphenhydramine hcl yet at the time of the report. She plans on taking some soon. The outcome of the event of tongue swelling was recovered on 14Jan2021 and outcome of other events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,PUB,TOPAMAX; WELLBUTRIN,,Medical History/Concurrent Conditions: Asthma; Glaucoma; Non-sustained ventricular tachycardia,,,"['Body temperature', 'Dysphonia', 'Erythema', 'Headache', 'Lip swelling', 'Swollen tongue']",UNK,PFIZER\BIONTECH, 986105,CA,38.0,F,"gastritis; heart burn; Chest pain; The EKG said she had a heart attack; This is spontaneous report from a contactable nurse (patient). A 38-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 13:00 at single dose at right arm for covid-19 immunization. Medical history included heart attack from Apr2019 to an unknown date, covid-19 from Jul2020 to an unknown date (really sick with it). The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient got the first COVID19 vaccine and a few days after started having chest pain on 02Jan2021 at 1:00AM, event was serious per medically significant. She went to the doctor and they did an EKG on 08Jan2021. The EKG said she had a heart attack. The heart attack was about the time she had chest pain after the first injection. Patient called her doctor on Monday, 04Jan2021. She had a televideo appointment on 06Jan2021. She went to the doctor's office and had EKG on 08Jan2021 and was sent to the hospital. She didn't get admitted because there were no beds. Outcome of the event chest pain, she would say she had recovered on 02Jan2021 with lasting effects because she was in the hospital again for the same thing. She went to the hospital the second time for chest pain that woke her up on 11Jan2021. It started at like 3AM. She thought it was heart burn. She tried to go back to sleep. It continued while she was at work. She told her supervisor who sent her to the hospital. They did not admit her. They did do an EKG on 11Jan2021 and it was abnormal, but not indicative of heart attack. Thought it was gastritis. Her doctor thought the heart attack was on the 02Jan2021. The same thing happened with her heart and she had a heart attack in Apr2019. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines administered on same date of the Pfizer suspect. Patient stated she didn't go to the ER, but called doctor's office on the following Monday. There was no adverse event following prior vaccinations. Outcome of event chest pain was recovered with sequel, and outcome of other events was unknown. Information on lot/batch number has been requested.; Sender's Comments: Based on the available information, a possible contributory role of the suspect BNT162B2 in the development of the events chest pain and heart attack cannot be excluded. The events are confounded by the patient's underlying cardiovascular conditions. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,PUB,,,Medical History/Concurrent Conditions: COVID-19 (really sick with it.); Heart attack,,,"['Chest pain', 'Electrocardiogram abnormal', 'Myocardial infarction']",1,PFIZER\BIONTECH, 986107,TN,63.0,F,"8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest; tightness bilateral flank area; HA; body aches; diaphoresis; hot feeling; numbness tingling of head; numbness tingling of head/tingling in jaw and over the top of my head; pressure in the back of my neck; blurred vision; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in right arm on 14Jan2021 10:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. Medical history included HTN, GERD, constipation, ocular migraine, osteoarthritis in sacroiliac joints, small fiber neuropathy, glucose intolerance, steatotic liver, CTS (Carpal tunnel syndrome). Concomitant medication included losartan (LOSARTAN), furosemide sodium (LASIX [FUROSEMIDE SODIUM]), and spironolactone (SPIRONOL). The patient previously received the first dose of bnt162b2 on 24Dec2020 10:00 AM for COVID-19 immunization. On 14Jan2021 11:00, the patient experienced tightness in chest tin which the patient took benadryl 25 mg with improvement, tightness bilateral flank area, HA, body aches, diaphoresis, hot feeling, numbness tingling of head, pressure in the back of my neck, and blurred vision. On 15Jan2021, the patient had an 8/10 chest pain radiating into left arm subsided after 10 mins, tingling in jaw and over the top of head, chest tightness and tightness in both flanks most of day 2. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162B2 administration to the event chest pain cannot be excluded. The status of medical history including HTN, GERD, constipation, migraine and osteoarthritis in sacroiliac joints would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,PVT,LOSARTAN; LASIX [FUROSEMIDE SODIUM]; SPIRONOL,,Medical History/Concurrent Conditions: Carpal tunnel syndrome; Constipation; GERD; Glucose intolerance; Hepatic steatosis; Hypertension; Migraine; Osteoarthritis; Small fiber neuropathy,,,"['Chest discomfort', 'Chest pain', 'Feeling abnormal', 'Feeling hot', 'Headache', 'Hyperhidrosis', 'Hypoaesthesia', 'Muscle tightness', 'Osteoarthritis', 'Pain', 'Paraesthesia', 'Skin tightness', 'Vision blurred']",2,PFIZER\BIONTECH, 986108,CA,38.0,F,"nasty headache; felt hot; Shivers; achy; Nauseous; eyesight/ felt like she was straining; sensitivity to light; eyeballs felt sore; cold sweats; when she talked, she felt like she had to close her eyes because of pressure; arm was hurting really bad; received the 2nd vaccine yesterday/ date of the first vaccine was 28Dec2020; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284, expiry date: 30Apr2021), intramuscularly on the left arm, deltoid on 14Jan2021 15:30 to 14Jan2021 15:45 at a single dose for COVID-19 immunization. Medical history included ongoing pernicious anaemia, a B12 deficiency diagnosed 2-3 years ago (she gave herself B12 shots and she cannot convert B12 through her food), and myomectomy (15 cm uterine fibroid, removed this past summer). Concomitant medication included ongoing cyanocobalamin (B12) for pernicious anemia. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284, expiry date: 30Apr2021), intramuscularly on the left arm, deltoid on 28Dec2020 at a single dose for COVID-19 immunization; and a flu shot (the MA gave it in the back of her arm, it was pretty significant). The patient was a nurse and informed that she received the second COVID vaccine the day before report (14Jan2021). She woke up on the day of report on 15Jan2021 03:00 with a nasty headache, she felt hot, had the creepy crawly shivers, was achy and when she talked, she felt like she had to close her eyes because of pressure, and she was nauseous. She figured this was probably normal but she couldn't get a hold of her doctor and the hospital she worked at did not know what to tell her. She was wondering if she can take Tylenol or ibuprofen and has even thought about drinking caffeine, that it might help her headache. She didn't have a prescribing doctor as she got it at work. The first round of the vaccine she only had a super mild sore arm and a slight headache. She received the second vaccine at 3:30pm and then went to bed when she got home. She woke herself up at 3 am because her arm was hurting really bad. She started feeling like she couldn't keep her legs still. She felt hot, achy, and was shivering. She hasn't taken her temperature. When she woke up at 3 am she got on her phone, and her eyesight felt like she couldn't quite focus. It wasn't bad, but she felt like she was straining. Then her head started hurting at 5-7 am. She was very sensitive to light. She woke up and couldn't go back to sleep. She had cold sweats, and was shivering. Every time she stood up, she was chattering. She felt achy almost like growing pains. She woke up with the arm pain, and then 10-15 minutes later, she started feeling that creepy crawly feeling. She got up and the cool fan hit her, and she realized how bad she was shivering. The shivering intensified at times but hasn't gotten worse. She had just called employee health and realized that when her eyes were open when she was talking was when she felt nauseated. She has noticed the nausea in the past half hour. She did not know if it was related to the headache or what. She had to cover her eyes, her eyeballs felt sore. When she talked with her eyes open, she felt a little queasy. She was just straining to see. Her vision was not blurry but she can tell she was straining. She did not know if it was because of the headache and nausea. When she got out of bed, the cold fan did not feel cold but it made her shiver. She was a nurse was trying to be socially responsible as she did not want to get COVID. She was a little suspicious because of the headache after the first one. She hasn't been around anyone in a couple of weeks and had been working from home. She has not been exposed to people. She kept feeling like she needed to stretch because she was sore. The patient was tested for COVID pre-surgery (myomectomy) and was negative. She was also tested for COVID antibodies and she did not have any. She was vaccinated at a hospital facility. Patient received no other vaccines on that day. The adverse events did not require any visit to the emergency room or physician office. Patient did not receive prior vaccines in the previous 4 weeks. Outcome of the events cold sweat and ""tested for COVID antibodies and she did not have any"" was unknown, nasty headache was reported as worsened (not recovered), and the remaining events was not recovered. The reporter considered the events serious due to medically significant events and related to the suspect drug.; Sender's Comments: Based on the information currently available, a possible contributory role of BNT162B2 vaccine in the development of the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,PVT,B 12,Pernicious anemia (B12 deficiency),"Medical History/Concurrent Conditions: Myomectomy (15 cm uterine fibroid, removed this past summer)",,,"['Asthenopia', 'Chills', 'Cold sweat', 'Dyskinesia', 'Eye pain', 'Feeling hot', 'Formication', 'Headache', 'Insomnia', 'Nausea', 'Ocular discomfort', 'Pain', 'Pain in extremity', 'Photophobia', 'SARS-CoV-2 antibody test negative', 'SARS-CoV-2 test negative', 'Vision blurred']",2,PFIZER\BIONTECH,OT 986110,TX,36.0,F,"feels tired; heart rate became very fast, it went into like the 150's; feeling jittery; Lightheadedness; weakness of lower extremities; Nauseated; felt really cold; probably had a fever; really thirsty; very hot; she wasn't feeling well; This is spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular (deltoid left) on 14Jan2021 18:25 at 0.3 mL, single for Covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took Bactrim and experienced allergy. The patient reported she did develop some side effects, but the hospital she received the vaccine at didn't know if it was an allergic reaction or what. She reported that a minute or two minutes after receiving the COVID-19 vaccine (14Jan2021), her heart rate became very fast, it went into like the 150's. She started feeling jittery, lightheaded, and she had some weakness of her lower extremities. She also felt nauseated. She didn't have any shortness of breath; she thinks she was okay there. She clarified that she had her mask on and they told her to remove her mask and to breathe, breathe, breathe. She had a pulse oximeter on, and her levels were always at 98, 96. She was told to sit still, and she was given water. Her heart rate went down to 76. She was fine and then after 5 minutes, she had the same reaction again. Her heart rate this time was in the 120's. She was lightheaded, cold, jittery. She did the same thing again and waited another 5- 10 minute. She felt better but was still nauseated, lightheaded, and really, really cold. She was kept there for 45 minutes. After that, she still did not feel 100%. Currently, she still does not feel 100% well. She was okay, she thinks she was okay. She explains they wanted to send her to the ER (emergency room) but she declined. Her heart rate had improved, she wasn't feeling like she was going to pass out. She wasn't experiencing shortness of breath, she wasn't throwing up, she didn't have a rash, her throat wasn't closing up, so she went back to work. She further stated that she came back home. Her heart rate was a little faster, but it wasn't as high as it had been. She still felt a little bit of weakness. At night (14Jan2021), she probably had a fever, she doesn't know. She was really thirsty and very hot. Because she was not feeling well, she didn't get up and drink anything. This morning (15Jan2021), she feels a little better. If she is doing her normal activities, she does get tired. She feels like she is running and is like ""okay I feel tired"". She has a little bit of weakness in her lower extremities. She was given information for reporting side effects, but because she wasn't feeling well, she didn't do any of it. She checked her heart rate today (15Jan2021) and it's at 76. She added that when she moves a lot, she feels tired and she doesn't know why. She's normally a very active person. She is no longer jittery, but still feels lightheaded. She has a little bit of nausea. She felt hungry so she made a shake and it's not like she is going to throw up, but she is still feeling yucky. She still has a little weakness of her lower extremities. They feel light, she doesn't know how to explain it. She is just a little bit concerned because this is a new vaccine. The outcome of event heart rate increased was recovering; outcome of event feeling jittery was recovered on an unspecified date; while the outcome of other events was unknown. The patient confirmed he doesn't believe it to be life threatening. She doesn't know if this is a severe allergic reaction. She was reading on the side effects the COVID-19 vaccine can cause. Per reporter all events were related to suspect product.; Sender's Comments: Based on the compatible time association, the contribution of suspect BNT162b2 to the event heart rate increased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,PVT,,,,,,"['Dizziness', 'Dyspnoea', 'Fatigue', 'Feeling cold', 'Feeling jittery', 'Heart rate increased', 'Malaise', 'Muscular weakness', 'Nausea', 'Sensory disturbance', 'Thirst']",1,PFIZER\BIONTECH,OT 986112,KY,53.0,F,"lost eyesight, everything went black; sweating really bad; cold chills; feels kind of achy; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) received from a contactable consumer. A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3249), intramuscular in left arm on 14Jan2021 12:00 at a single dose to prevent COVID-19. Medical history included shingles recently and was not given any medicine for that and breast cancer when she was 29 so she can't have shots on her right side. There were no concomitant medications. On 15Jan2021 05:00, she went to the bathroom and everything went black. When her eyesight did come back after a while, she was sweating badly and had the chills. As soon as her husband helped her get back to bed, she started sweating really bed. Her nightclothes were soaked, it wasn't like a normal sweat. She also got the cold chills. She got the cold chills right after she had the experience with her eyesight. She was just kind of achy. However, the sweating, chills, and achiness are all listed on the form she has. She isn't really worried about that. The patient was more concerned about the fact she couldn't see anything. Caller wanted to know if losing her eyesight is a side effect of the vaccine. She confirmed her eyesight came back. The outcome of the event losing her eyesight was recovered while the outcome of the remaining events was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/15/2021,1.0,OTH,,,Medical History/Concurrent Conditions: Breast cancer (She mentions she had breast cancer when she was 29 so she can't have shots on her right side); Shingles (She did have shingles recently and they had to give her medicine for that.),,,"['Blindness', 'Blindness transient', 'Chills', 'Hyperhidrosis', 'Loss of consciousness', 'Pain']",1,PFIZER\BIONTECH,OT 986114,MO,39.0,F,"by night bilateral arm heaviness; 8 days out: right forearm weakness paresthesia/pins and needles sensation across neck shoulders extending to upper arms; 7 days after 2nd injection right foot/calf numbness; quadriceps weakness/11 days out left quadriceps weakness; This is spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the second dose of BNT162B2, via an unspecified route of administration in right arm on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hypothyroidism and known allergies: Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID), colecalciferol (VITAMIN D), and ubidecarenone (COQ10). Patient previously received the first dose of BNT162B2 on 15Dec2020 09:00 in right arm for COVID-19 immunization. 7 days after 2nd injection right foot/calf numbness quadriceps weakness on 12Jan2021 21:00. 8 days out: right forearm weakness paresthesia on 13Jan2021. 11 days out left quadriceps weakness, by night bilateral arm heaviness on 16Jan2021. 12 days out pins and needles sensation across neck shoulders extending to upper arms on 17Jan2021. Deep tendon reflexes intact throughout. Bladder function intact. Events resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was not received for these events. Outcome of events was not resolved. Information about lot/batch number is requested.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/12/2021,7.0,PVT,SYNTHROID; VITAMIN D [COLECALCIFEROL]; COQ10 [UBIDECARENONE],,Medical History/Concurrent Conditions: Hypothyroidism; Penicillin allergy,,,"['Hyperreflexia', 'Hypoaesthesia', 'Limb discomfort', 'Muscular weakness', 'Paraesthesia']",2,PFIZER\BIONTECH, 986115,CA,65.0,F,"Suffered a massive MCA stroke; This is a spontaneous report from a Contactable Nurse. A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), intramuscularly in left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. Medical history included covid prior vaccination. Known allergies: None. The patient's concomitant medications were not reported. The patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1685), intramuscularly in right arm on 21Dec2020 03:00 PM at single dose for COVID-19 immunization. The patient was not pregnant while receiving vaccine. Facility type vaccine: Hospital. If other vaccine in four weeks: No. Other medications in two weeks: No. The patient suffered a massive MCA (Middle cerebral artery) stroke on 21Jan2021 08:00 after getting second covid vaccine with outcome of not recovered. No history of hypertension, elevated cholesterol or medical issues. No medication being taken. Daily BP (Blood pressure) reading normal. Covid test post vaccination: Nasal Swab-PCR on 22Jan2021 with result negative. If treatment for AE: Unknown. The event was resulted in: Emergency room/department or urgent care, Hospitalization (Number of days hospitalization: 4), Life threatening illness (immediate risk of death from the event), Disability or permanent damage.; Sender's Comments: The event middle cerebral artery stroke appeared 8 days after administration BNT162B2. The Company considers that the event is less likely related to suspect BNT162B2 injection given the weak time association. The status (bleeding or infarction) and cause of the stroke would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,4.0,Yes,N,01/12/2021,01/21/2021,9.0,PVT,,,Medical History/Concurrent Conditions: COVID-19,,,"['Cerebrovascular accident', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,OT 986116,IN,85.0,M,"like a blood clot; All around eye is real swollen and puffy and in corner/don't know if it looks like a bruise or it's like a blood clot or something; like a bruise; a red, dark red spot/not on the eye but up on the eyelid it looks like; all around his eye was real swollen and puffy and in the corner, not on the eye but up on the eyelid it looks like; This is a spontaneous report from a contactable consumer. An 85-year-old male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number like EL1283), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. Medical history included slightly elevated blood pressure from an unknown date. Concomitant medication included clopidogrel besylate (CLOPIDOGREL) for blood pressure; hydrochlorothiazide, losartan potassium (LOSARTAN + HIDROCLOROTIAZIDA) as blood thinner and several of drugs. The patient had the Covid vaccine on the 12Jan2021 and yesterday (14Jan2021) as they noticed his eye, all around his eye was real swollen and puffy and in the corner, not on the eye but up on the eyelid it looks like, the reporter didn't know if it looks like a bruise or it's like a blood clot or something and it's still there, it hasn't gone away and they didn't know if this was from the vaccine, the reporter didn't know if it's bruise or if it's a clot the reporter didn't know, it's a red, dark red spot. after we had the vaccine they gave us a paper that had some information on it and it said on there they should advise them if on blood thinners, they did not told beforehand and the patient was on blood thinners. No treatment was received. The outcome of the events was not recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/14/2021,2.0,UNK,CLOPIDOGREL [CLOPIDOGREL BESYLATE]; LOSARTAN + HIDROCLOROTIAZIDA,,Medical History/Concurrent Conditions: Blood pressure increased,,,"['Erythema of eyelid', 'Eye swelling', 'Periorbital swelling']",UNK,PFIZER\BIONTECH, 986118,WA,81.0,F,"She was cleaned out, pretty much cleaned out of her bowels, but she kept getting pains and started passing blood clots; She kept getting pains; Bad stomach cramps; Diarrhea; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date unknown), via an unspecified route of administration, on 14Dec2020 10:00 at a single dose for COVID-19 immunization. Medical history included hypertension from an unknown date. Concomitant medication included atorvastatin, losartan, alprazolam, mirtazapine, and several medications because of her age and she has hypertension. The patient had her vaccine on 14Dec2020 at about 10 o'clock and a couple of hours later she began getting really bad stomach cramps and had diarrhea for most of the day and about 11 o'clock of 14Dec2020 she reported she was cleaned out, pretty much cleaned out of her bowels, but she kept getting pains and started passing blood clots. Treatment for the events include Some Pepto-Bismol (as reported). The outcome of the event ""bad stomach cramps"" was not recovered, and for other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/14/2020,12/14/2020,0.0,UNK,ATORVASTATIN; LOSARTAN; ALPRAZOLAM; MIRTAZAPINE,,Medical History/Concurrent Conditions: Hypertension,,,"['Abdominal pain upper', 'Bowel movement irregularity', 'Diarrhoea', 'Diarrhoea haemorrhagic']",1,PFIZER\BIONTECH, 986119,NC,93.0,F,"Normally, patient has neuropathy but it has never been this bad before and it has never been that high up.; Terrible cramps in both legs and thighs; This is a spontaneous report from a contactable consumer who reported for herself, a 93-year-old female patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), via an unspecified route of administration on 15Jan2021, at the age of 93 years, at a single dose for COVID-19 immunization. Medical history included diabetes and neuropathy, both ongoing. Concomitant medications included unspecified medicines including one for diabetes. The patient stated that she received her shot yesterday, 15Jan2021 and last night, same day of vaccination 15Jan2021, she had terrible cramps in both legs and thighs and was just wondering if that was one of the symptoms. Normally, patient has neuropathy but it has never been this bad before and it has never been that high up (15Jan2021). The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/15/2021,0.0,UNK,,Diabetes; Neuropathy,,,,"['Muscle spasms', 'Neuropathy peripheral']",UNK,PFIZER\BIONTECH, 986122,TN,68.0,M,"acute myocardial infarction; He was found by his secretary unconscious; feeling unwell; This is a spontaneous report from a contactable nurse. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), intramuscular in the left arm on 19Jan2021 (at 68-years-old) as a single dose for COVID-19 immunization. Medical history included blood cholesterol of 200 (not further specified). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2020 at 08:00, after the vaccine, that patient was at work and was feeling unwell and the patient was found by his secretary unconscious. An ambulance was called. The patient's blood pressure was 79/38 and electrocardiogram showed acute myocardial infarction. He underwent one stent placement with the remaining arteries normal. He was also started on ticagrelor (BRILINTA), metoprolol (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). The patient immediately improved and was feeling well and resumed exercise. The clinical outcomes of the unconscious, acute myocardial infarction, and feeling unwell were recovering. The events required emergency room visit and were assessed as serious for requiring hospitalization for 2 days and being life-threatening. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: There is not a reasonable possibility that reported events acute myocardial infarction, unconsciousness and feeling unwell are related to BNT162B2. The events are more likely intercurrent medical condition for this elderly patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/19/2021,01/19/2021,0.0,PVT,IRBESARTAN,,Medical History/Concurrent Conditions: Blood cholesterol abnormal,,,"['Acute myocardial infarction', 'Blood cholesterol normal', 'Electrocardiogram abnormal', 'Loss of consciousness', 'Malaise', 'Stent placement']",1,PFIZER\BIONTECH,OT 986123,AZ,,M,"passed away-heart attack; This is a spontaneous report from a contactable consumer, the daughter of the patient from a Pfizer Sponsored program Pfizer First Connect. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 19Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 24Jan2021, the patient passed away due to a heart attack. It was not reported if an autopsy was performed. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away-heart attack",Yes,01/24/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/24/2021,5.0,UNK,,,,,,"['Death', 'Myocardial infarction']",1,PFIZER\BIONTECH, 986124,NC,87.0,M,"Delirious; He woke up sick on stomach and throwing up; He woke up sick on stomach and throwing up; This is a spontaneous report from a contactable consumer (son). An 87-year-old male patient received BNT162B2 (lot number: EK9231, expiration date: 30Apr2021) first dose on 15Jan2021 around lunch time at single dose for COVID-19 immunization. Medical history included high sugar and COPD (Chronic obstructive pulmonary disease). Concomitant medications included gabapentin, metformin, ferrous sulfate, acetylsalicylic acid (ASPIRIN 81). Patient took the vaccine 15Jan2021 around lunch time and this morning (16Jan2021) he woke up sick on stomach and throwing up and kind of 'deluce' or delirious. Consumer just started giving patient fluids and Pepto Bismol as treatment. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/16/2021,1.0,UNK,GABAPENTIN; METFORMIN; FERROUS SULFATE; ASPIRIN 81,,Medical History/Concurrent Conditions: COPD; Sugar blood increased (Verbatim: High sugar),,,"['Abdominal discomfort', 'Delirium', 'Vomiting']",1,PFIZER\BIONTECH, 986126,,,U,"It was probably a Pleurisy and put me on a steroid (Unspecified Medication); I am a little bit more winded today than I was before and my heart rate is a little faster than I normally run; I am a little bit more winded today than I was before and my heart rate is a little faster than I normally run; Pain in my left shoulder clavicle area when I took a really deep breath and it got worse; Pain in my left shoulder clavicle area when I took a really deep breath and it got worse; This is a spontaneous report from a contactable consumer (patient). A patient received second dose of bnt162b2 (Lot Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient had second Covid vaccination (manufacturer not clarified, hence is this a Pfizer product tab left unchecked) on the 8th (not clarified). This Friday (15Jan2021), patient started getting pain in left shoulder clavicle area when took a really deep breath and it got worse yesterday. So, patient went to Institute, they did a test X-ray on 16Jan2021 and they did not see anything. He said, it was probably Pleurisy and put me on a steroid (Unspecified Medication). Today, like the pain is a little bit better but patient was a little bit more winded today than it was before and heart rate was a little faster (17Jan2021) than normally run and just do not know if this was something that was being reported or what. The outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/15/2021,,UNK,,,,,,"['Arthralgia', 'Dyspnoea', 'Heart rate increased', 'Pleurisy', 'X-ray normal']",2,PFIZER\BIONTECH, 986127,PA,35.0,F,"Troponin, which is a cardiac enzyme or a heart test to be high; test continued to stay high for the 24 hours when they have done three different test at 8 hours apart; I might have myocarditis which is inflammation of the heart muscle as a result of the vaccine; I am having side effects affecting the heart because my cardiac enzymes are high; Rash that can happen from low platelet on both of my arm, for which I came to the emergency room; Rash that can happen from low platelet on both of my arm, for which I came to the emergency room; I am having side effects affecting skin because I am having rash; I am side effects affecting the immune system because my lymph nodes are enlarged; I have swelling at the site of injection; My lungs because I was wheezing; I was having lung symptoms; I have any irregular rhythm; I started having low grade fever and myalgia; I had similar low grade fever and myalgia with my first dose; I started having low grade fever and myalgia; I had similar low grade fever and myalgia with my first dose; I started having high grade fever, maximum temperature of 101.5 degree Fahrenheit; Wheezing; Dyspnea on excursion which is basically shortness of breath when I go up and down on the stairs; Chest tightness; This is a spontaneous report from a contactable Physician (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunisation. Medical history included asthma exercise induced from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received the first dose of BNT162B2 on unknown date and experienced low grade fever and myalgia. On 15Jan2021 the patient experienced Dyspnea on excursion which is basically shortness of breath when I go up and down on the stairs; Chest tightness; I started having high grade fever, maximum temperature of 101.5 degree Fahrenheit; Wheezing. On 16Jan2021 the patient experienced rash that can happen from low platelet on both of my arm, for which I came to the emergency room (hospitalization). On unknown date the patient experienced Troponin, which is a cardiac enzyme or a heart test to be high; test continued to stay high for the 24 hours when they have done three different test at 8 hours apart (hospitalization); I might have myocarditis which is inflammation of the heart muscle as a result of the vaccine (hospitalization); having side effects affecting the heart because my cardiac enzymes are high (hospitalization); I have any irregular rhythm; I started having low grade fever and myalgia; I had similar low grade fever and myalgia with my first dose; I am having side effects affecting skin because I am having rash; I am side effects affecting the immune system because my lymph nodes are enlarged; I have swelling at the site of injection; My lungs because I was wheezing; I was having lung symptoms. The patient underwent lab tests and procedures which included blood test: unknown results on unknown date; body temperature: 101.5 fahrenheit on 15Jan2021, chest x-ray: unknown results on unknown date; echocardiogram: unknown results on unknown date; EKG: unknown results on unknown date, cardiac enzyme: high on 16Jan2021, platelet count: low on unknown date . The outcome of the events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/14/2021,01/15/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Exercise induced asthma,,,"['Blood test', 'Chest X-ray', 'Chest discomfort', 'Condition aggravated', 'Dyspnoea exertional', 'Echocardiogram', 'Electrocardiogram', 'Injection site swelling', 'Lymphadenopathy', 'Myalgia', 'Myocardial necrosis marker increased', 'Platelet count decreased', 'Pyrexia', 'Rash', 'Respiratory symptom', 'Troponin increased', 'Wheezing']",2,PFIZER\BIONTECH, 986129,NY,49.0,F,"Fullness under my armpit which is on the same side as the vaccine, which looks like swollen lymph nodes under my armpit/kind of benign; Generalized malaise low grade; Headache; Both eyes are very swollen; inflammatory prosthesis in my eye; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247) via an unspecified route of administration at arm on 15Jan2021 11:00 at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Nurse stated that she just wanted to report what she thinks is adverse reaction to the Covid-19 vaccine from Pfizer not sure what to do about it at this point. She was vaccinated Friday 11 o'clock in the afternoon. Both days felt really fine. Last night (16Jan2021) got some fullness under her armpit which was on the same side as the vaccine, which looked like swollen lymph nodes under her armpit which you can see was kind of benign. But in addition to that some generalized malaise lowgrade and headache (Jan2021). Seems totally fine but her both eyes are very swollen (Jan2021). Nurse took some ibuprofen (ADVIL)-600 mg, she was taking Prednisone for inflammatory prosthesis in her eye as treatment (Jan2021). Outcome of the events was unknown. The nurse considered the occurrence of the events are because of COVID-19 Vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Swollen eyes and Eye inflammation cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Eye swelling', 'Headache', 'Injection site lymphadenopathy', 'Malaise', 'Oedema peripheral']",UNK,PFIZER\BIONTECH, 986130,GA,57.0,F,"increased heart rate after that it started getting worse; a warm feeling in her chest like tingling; kind of short of breath; left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand; Chills; Fatigue; GI problems; still have some issue, did not feel good, off and on; SARS Covid antibodies test says positive; This is a spontaneous report from a contactable other nurse (patient) from a Pfizer sponsored program Pfizer First Connect. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose (lot number: EJ1685) on Deltoid Left for covid-19 immunisation. Medical history included Paroxysmal supraventricular tachycardia. The patient's concomitant medications were not reported. The patient experienced a warm feeling in her chest like tingling; kind of short of breath, it went away like she said it was just breath it was like for couple of minutes and then it went away and then she was just fine till it's been long here honestly about 3 or 4 days later; got shot in her right arm but left hand start swelling up first a little bit and then her left arm start swelling up and it's just and then that's the base and then her right hand start very, very mild swelling in her right hand. The hospital think there as some clot or something weird but she did not and then that started going down after that it just started going down and went away and never had swelling since then but this was going to long but this was something weird happened to her. She got chills, She got fatigue. She had increased heart rate after that it started getting worse. She had Paroxysmal supraventricular tachycardia, she had that always but it's been control. She walked 5 miles daily a day, she was in shape, she had lot since then, so it's been under control, she never had problem with it until after she got the shot, her heart rate was she had to add medication, she never have to add. She took metoprolol (Treatment) so she added that and she added more and that's thing get it under control and then she take herself back off because she felt like it was under control but she had GI problems since, now she was getting better now, still have some issue, did not feel good, off and on. The patient underwent lab tests and procedures which included blood test: good on 04Jan2021 (blood work to see if something was going on to her heart, because she had short breath, and everything was good), weight: 166 or 164, SARS Covid antibodies test IgM on 04Jan2021: positive. Treatment: Nurse stated, ""No, not now, I had a heart-rate monitor, it's what for see what is my heart rate, to locate and see what's going on."" Outcome of left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand was recovered.; Sender's Comments: There is not a reasonable possibility that event heart rate increased is related to BNT162B2. The event is most likely due to underlying paroxysmal supraventricular tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,01/04/2021,18.0,UNK,,,Medical History/Concurrent Conditions: Paroxysmal supraventricular tachycardia,,,"['Blood test normal', 'COVID-19', 'Chills', 'Dyspnoea', 'Fatigue', 'Feeling hot', 'Gastrointestinal disorder', 'Heart rate increased', 'Malaise', 'Paraesthesia', 'Peripheral swelling', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 antibody test positive']",UNK,PFIZER\BIONTECH, 986145,OK,68.0,F,"On the two hour ride home, my arm would ache then be fine. I was cranky, not myself, going to bed, I woke several times as I rolled over onto my right arm. When I awoke early, I was swollen from Head to Toes, my eyes were slits, my bracelets and rings were swollen into my skin, and my toes and ankles were large. AND I was grouchy about everything. As the day went on I was just mad about everything, I began to drink lots of water and tried to exercise to get the swelling down. About noon, my eyes and face began to ease, but my body didn't ease till about 2pm, as my rings and bracelets were movable then. I am still swollen and still angry and it is Friday.",Not Reported,,Yes,Not Reported,,Yes,N,01/26/2021,01/27/2021,1.0,UNK,"Bi0-Hormones, Bone up, Strontiom, Vit. D, Folic Acid, Collagen Type 1 & 3, Omega 7 1000 mg, Quercetin Aller-Plex, Lovasa, Methydopa, Montelukast, Aspirin 81 mg, Zyrtec, Probiotic, L-Lysine, Bystolic, Frova as needed",none,"Migraines, sinus and ear infections",,"All types of steroids, Nitroglycerin, Migranal, Neurontin, Depakote, Tramadol, Cerebyx, lisinopril, Meloxicam, Tobdramycin, Cefdinir , Atenolol, Verapamil, Hydrocodone, Oxycodone, Percocet, Azithromycin, Otovel, Neomycin-Polumyxin, Tobradex, Loteman, Lorsatan","['Irritability', 'Pain in extremity', 'Poor quality sleep', 'Swelling']",1,PFIZER\BIONTECH,SYR 986200,NM,82.0,F,Death,Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/15/2021,16.0,PUB,"Atorvastatin, Metformin and Atenolol.",None.,Uncontrolled DMII and HTN.,,NKA.,['Death'],1,PFIZER\BIONTECH,IM 986330,MI,46.0,F,Syncope. Breathing but unresponsive. Dizziness and weakness prior to syncope event.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/25/2021,01/25/2021,0.0,OTH,"Guaifenesin 400 MG, Hyoscyamine Sulfate, Ondansetron, Pseudoephedrine 30 MG, Ropinirole 0.5 MG",,"GERD (gastroesophageal reflux disease) Nervous Migraine CTS (carpal tunnel syndrome) Neck pain Arm pain, right Arm paresthesia, right Myofascial pain syndrome Other Allergy, unspecified not elsewhere classified Lump or mass in breast Spondylosis of cervical joint without myelopathy",,"Bactrim, Sulfamethoxazole, Trazodone","['Asthenia', 'Dizziness', 'Syncope', 'Unresponsive to stimuli']",UNK,MODERNA,IM 986355,CA,58.0,F,"Same day when I got the vaccine I started feeling hot & dizzy I asked a nurse to check my temperature and it was at 101F, I left home the next day in the morning I was low on oxygen they had to called the ambulance and they took me to the ER. I was hospitalized since 01/5/2021- 01/17/2021 the fever continued during that time but as it right now I'm still with oxygen I also have a cough. The doctors said it affected my lungs. On February I should be getting another lung exam.",Not Reported,,Not Reported,Yes,12.0,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,High Blood Pressure Medication Vitamins,dry cough,No,,No,"['Cough', 'Dizziness', 'Feeling hot', 'Oxygen saturation decreased', 'Pyrexia']",1,MODERNA,SYR 986434,IL,43.0,F,"Next day fever 100.8 and chills. 2 days later very bad headaches that lasted until 1/23. ER visit on 1/21 for chest pressure, lightheadedness, dizzy. Cardiac work up- negative. Discharged. Still lightheaded and dizzy 1/22 - 1/24. On 1/25 sharp chest pains went to see my PCP. She prescribed a steroid pack. 1/26 at 3:30 pm felt weak, felt like I was going to black out. Went back to the ER- full cardiac work up, head CT, admitted to the hospital for observation. Stress test on 1/27. Everything normal. Follow up with PCP on 1/29 still very lightheaded. Ordered a 48 hour heart monitor and Neurology consult.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/11/2021,01/12/2021,1.0,PVT,Tylenol,None,Menstrual Migraines,,None,"['Activated partial thromboplastin time', 'Activated partial thromboplastin time normal', 'Asthenia', 'Blood folate', 'Blood magnesium', 'Cardiac stress test normal', 'Chest X-ray', 'Chest discomfort', 'Chest pain', 'Chills', 'Computerised tomogram', 'Dizziness', 'Electrocardiogram', 'Feeling abnormal', 'Fibrin D dimer', 'Full blood count', 'Headache', 'Lipase', 'Metabolic function test', 'Prothrombin time', 'Pyrexia', 'Red blood cell sedimentation rate', 'Red blood cell sedimentation rate normal', 'SARS-CoV-2 test', 'Troponin', 'Vitamin B12', 'X-ray']",2,PFIZER\BIONTECH,IM 986449,FL,47.0,F,"Immediately after the 1st injection employee had tachycardia, hypertension, nausea, dizziness, hot flash, ringing in the ears, sweating. Was monitored for 30 minutes and symptoms resolved. Approximately 10 hours after 2nd vaccine employee had nausea, vomiting, fever, body aches and cramps, chills, headache. Approximately 18 hours post 2nd vaccine, Lymph nodes in neck began to swell and throat was scratchy and having difficulty swallowing.",Not Reported,,Yes,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PVT,"Multi-vitamin, fish oil,CoQ10, D3, B12",No,Asthma,,No allergies,"['Chills', 'Computerised tomogram', 'Dizziness', 'Dysphagia', 'Full blood count', 'Headache', 'Hot flush', 'Hyperhidrosis', 'Hypertension', 'Immediate post-injection reaction', 'Laboratory test', 'Lymphadenopathy', 'Metabolic function test', 'Muscle spasms', 'Nausea', 'Pain', 'Pyrexia', 'Tachycardia', 'Throat irritation', 'Tinnitus', 'Vomiting']",1,MODERNA,IM 986463,UT,32.0,F,"24 weeks pregnant at time of 2nd shot. Shot given at 1430 on 1/27 in left deltoid. Felt great rest of day. @0500 on 1/28 woke up shivering uncontrollably. Mild fever of 100.5(highest recorded during this whole episode). Body aches, chills, sweats, headache rest of day. 1000 mg Tylenol helped with fever/chills but headache progressed to migraine w/nausea. Took 50 mg sumatriptan and 25 mg doxylamine in evening and this seemed to help with headache and allow me to get to sleep 1/28. Woke up at 0300 1/29 with chills/cold sweats. Took 1000 mg Tylenol again (didn't check temp) and went back to sleep. Woke up at 0530 for work - checked temp since I'm a healthcare worker and it was 100.4 (with tylenol). Waited until clinic opened up and called them at 0700 for recommendations on going to work or not (temp by then was 99.8, with tylenol). Was advised to stay home and if febrile tomorrow to get COVID tested on 1/30. As of right now (1300 on 1/29) headache has returned but mild. Body aches still. Temp 99.4 w/tylenol redosed at 1000.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/28/2021,1.0,PVT,Wellbutrin 300 mg qd Propranolol 10 mg qd Tylenol 1000 mg prn Doxylamine succinate 25 mg qhs prn,None,Depression/anxiety,,Penicillin Venlafaxine,"['Chills', 'Cold sweat', 'Exposure during pregnancy', 'Headache', 'Hyperhidrosis', 'Impaired work ability', 'Migraine', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 986464,FL,50.0,F,"Response (1/27) after receiving 2nd dose of Moderna COVID-19 vaccine (~1840), c/o itching, throat swelling, SOB, racing heart & nausea about 50min after vaccination. S/p IM Epi, Benadryl, Pepcid, Solumedrol & Racemic Epi. CCM consulted. Close monitoring in ICU overnight. (1/28) Symptoms resolved, plan to discharge home with Rx for Epi pen.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/27/2021,01/27/2021,0.0,PVT,"aspirin, atorvastatin, carvedilol, EpiPen, losartan, Seroquel, synthroid",,,,"Gadavist, iodine, motrin, Zofran","['Dyspnoea', 'Intensive care', 'Nausea', 'Palpitations', 'Pharyngeal swelling', 'Pruritus']",2,MODERNA,IM 986501,OH,30.0,F,"7:00 pm that night, my arm started to hurt very intensely and then the next day when I woke up and it hurt - felt like it broke my arm. It hurt really bad - couldn't left it or move it. I took Tylenol once or twice that day with six hours in between. I was a little bit drowsy and headache and a little bit nauseous. So I slept that day. I felt like my arm got hit by truck. 10th - I felt better that day. By Monday, the 11th, I was totally fine. Pregnancy: I'm due May 29, 2021; I have had a miscarriage before so it's my second pregnancy. So far everything has been normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,WRK,prenatal vitamin; fish oil; iron; fluoxetine 20 mg; vit B6,no,chronic diarrhea,flu shot - I have had my arm hurt and felt sick afterwards. It was milder symptoms than this. 2018; 2019 made me feel bad. 2020 ,Zithromax - get hives,"['Exposure during pregnancy', 'Headache', 'Mobility decreased', 'Nausea', 'Pain in extremity', 'Somnolence']",1,MODERNA,SYR 986526,MA,34.0,F,"1/9/21 woke up with fever, body aches and fatigue. 1/10/21 developed right lower back pain radiating to right side and right lower quadrant without any known injury. Presented to ER on 1/11/21 and was found to have elevated liver enzymes. 1/12/21 woke up with right thigh numbness and was referred to spine specialist by PCP. Saw spine specialist on 1/14/21 and was referred to physical therapy and given medrol dose pack taper. Repeated liver enzymes after 1 week resulted with abnormal results and referred to GI doctor. 1/28/21 Developed worsening right thigh numbness with decreased strength to right leg and following up with spine specialist on 02/01/21.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/08/2021,01/10/2021,2.0,WRK,Zoloft,None,,,None,"['Abdominal pain lower', 'Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Asthenia', 'Back pain', 'Computerised tomogram abdomen', 'Computerised tomogram pelvis', 'Fatigue', 'Hepatic enzyme increased', 'Hypoaesthesia', 'Pain', 'Pyrexia', 'Ultrasound abdomen normal']",2,PFIZER\BIONTECH,IM 986539,MS,73.0,M,"PT was in waiting area for his 15 min wait. about 10 minutes after receiving vaccine, pt complained of chest pain. Pt had a pacemaker and had a cardiology appointment previously where provider instructed pt to receive covid vaccine. EMS assist was initiated and ER staff responded within 3 minutes of notification. Pt has been admitted to inpatient unit for observation",Not Reported,,Not Reported,Yes,,Not Reported,,01/29/2021,01/29/2021,0.0,MIL,,,,,,['Chest pain'],1,PFIZER\BIONTECH,IM 986540,TN,73.0,M,"Patient was given vaccination on 1/22/21 @ 0940am. Patient was well at the time. Patient reported running a low grade temp over the weekend no higher than 100.1. On Monday 1/25/21 @ 1205pm, patient spiked temp of 105.1. Patient became very confused, lethargic, and unable to make coherent statements. Patient was given 2 Tylenol by family member and taken to Hospital at this time. Patient tested positive for Covid 19 at this time and was admitted into the hospital and d/c on 1/28/21.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/22/2021,01/25/2021,3.0,PUB,Multiple Medications. List not available at the time of VAER'S report,1 Ear Infection on 1/18/21,"COPD, DM, and Chronic Pain",,"Levaquin, Iodine, Bactrim, Toradol, and Bioxin","['Confusional state', 'Incoherent', 'Lethargy', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 986545,CA,55.0,M,Serious anaphylaxis started at 630 PM the day after the Moderna dose was administered . I ended up at the Medical Center ICU for two days before conditions abated and I could be discharged .,Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/25/2021,01/26/2021,1.0,OTH,Toprol lisinipril spironolact atorvastatin omega 3 fish oil co q 10,none,heart condition,,none known,"['Anaphylactic reaction', 'Blood test', 'Intensive care']",1,MODERNA,IM 986558,NY,66.0,F,"Extreme, extreme pain and increasing pain in upper left arm and near shoulder. Not able or barely able to move arm. Any little movement or effort causes extreme pain. Gets worse wit time passage.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/27/2021,01/28/2021,1.0,PHM,"Dulera, Trokendi, Valsartan, Deplin",,"Asthma, CKD, Controlled HBP",,,"['Injected limb mobility decreased', 'Injection site pain', 'Pain']",UNK,MODERNA,IM 986611,,46.0,M,"Difficult to determine if this event was related to vaccination. 46 y.o. male with a pertinent interval and past history of HTN, sponge kidney, ckd, gerd and HLD. Presents to ED with worsening redness and tenderness of his right upper mid thigh. Patient states that he got the Pfizer vaccination yesterday second shot evening and then developed some subjective fevers sweats and chills. Also had myalgias this all lasted approximately 2 hours but he was able to get to bed and fall asleep. Woke up this morning feeling better but still with some chills but noticed some tenderness and redness in his right upper mid thigh. This got progressively worse. Continues to have chills but improving. � ED work-up including CBC unremarkable, CMP with mild hyponatremia and hypokalemia of 134 and 3.4 respectively. ED drew blood cultures and then started vancomycin. Vitals normal and stable in ED. Admitted to hospital. Provider notes on 2nd day of admission as follows. Cellulitis and abscess of the right medial thigh likely secondary to a skin tag tear which introduced infection. Patient currently is on broad-spectrum antibiotics in the form of doxycycline and vancomycin. Unfortunately, the patient has been eating just ate lunch and also has been getting Lovenox. He is not going to tolerate a bedside incision and drainage. We will plan on proceeding to the operating room tomorrow for quick I&D and cultures. Procedures been explained. The wound will need to be packed afterwards and ultimately healed in. Patient seems understand plan and we will proceed accordingly",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/27/2021,01/28/2021,1.0,PVT,"amlodipine, aspirin, hydrochlorothiazide, losartan, omeprazole, sertraline",,"Chronic kidney disease, depression, GERD, hypertension",,Codeine,"['Abscess limb', 'Blood culture', 'Cellulitis', 'Chills', 'Erythema', 'Full blood count normal', 'Hyperhidrosis', 'Hypokalaemia', 'Hyponatraemia', 'Infection', 'Metabolic function test', 'Metabolic function test abnormal', 'Myalgia', 'Pyrexia', 'Skin laceration', 'Tenderness']",2,PFIZER\BIONTECH,IM 986631,MI,87.0,F,Suspected myocardial infarction on 01/15/2021. Patient passed away on 01/15/2021.,Yes,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/15/2021,1.0,SEN,,,"Hypertension, hyperthyroidism",,No known allergies.,"['Death', 'Myocardial infarction']",1,MODERNA,SYR 986636,MO,80.0,M,"Patient waited 15 minutes after injection at the vaccine clinic. Shortly after leaving the clinic (less than 1 hour), the patient was taken by ambulance to the hospital experiencing cardiac issues. Patient was air-lifted to larger hospital and later diagnosed with myocardial infarction.",Not Reported,,Yes,Yes,,Not Reported,U,01/28/2021,01/28/2021,0.0,PHM,Unknown,Unknown,Unknown,,None Reported,"['Cardiac disorder', 'Myocardial infarction']",1,MODERNA,IM 986640,CA,77.0,F,Hypertensive urgency and acute CHF exacerbation with hypoxia. Hospitalized for diuresis with furosemide. Currently much improved and discharged home. Symptoms started night of 1/22/2021. Worsened 1/25. Went to urgent care 1/26 and sent to hospital where she was admitted 1/26-28. Patient diagnosed with COVID-19 and was hospitalized for acute respiratory failure not requiring intubation in Jun 2020.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/22/2021,01/22/2021,0.0,PVT,"Atenolol, clopidogrel, furosemide, gabapentin, losartan, omeprazole, potassium chloride 10 mEQ, pramipexole, simvastatin",no known,"HFpEF, hypertension, class 3 obesity, GERD, OSA on CPAP, peripheral arterial disease, restless leg syndrome, controlled type 2 diabetes",,sulfa drugs,"['Angiogram', 'Arteriogram coronary abnormal', 'Brain natriuretic peptide increased', 'Cardiac failure congestive', 'Condition aggravated', 'Endotracheal intubation', 'Hypertensive urgency', 'Hypoxia', 'Polyuria']",1,PFIZER\BIONTECH,IM 986672,AZ,77.0,M,"Patient tested Covid positive, cough, low oxygen levels, COVID Pneumonia, patient is now deceased",Yes,01/28/2021,Not Reported,Yes,3.0,Not Reported,N,01/01/2021,01/15/2021,14.0,PUB,125 MG/5ML Suspension 5 ml in AM and 10 ml in PM Orally thru feeding tube Seroquel 50 MG Tablet 1 tablet Orally Once a day (crush and mix with water and thru feeding tube) Naproxen 125 MG/5ML Suspension 10 ml with food or milk Orally,none,"CVA, seizures, Lung nodule",,iodine topical betadine,"['COVID-19 pneumonia', 'Cough', 'Death', 'Oxygen saturation decreased', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 986735,TX,63.0,F,"First Moderna vaccine administered 12/23/2020. On or about 12/24/2020 paresthesia began in forearm and upper. On or about 12/28/2020 mild to moderate 5/10 began of left shoulder radiating down to left arm, x-rays were done on left shoulder and humerus. No acute findings noted. Few days later Medrol dose pak was ordered due worsening pain of left upper back, left arm and hand. 01/19/2021 telemedicine with MD to get stronger pain medication. Norco 10/325 mg was prescribed. 1/20/2021 second Moderna was given. ~pain 8/10 started morning of 1/21/2021. I used heat/ice therapy and Norco pain decreased to 7/10. Morning of 1/22/2021 pain ( upper back entire left arm and left chest wall) became unbearable thus, went to ER to rule out heart attack. I was admitted for pain management and cardiac monitoring. CT of the c-spine and t- spine was ordered. No acute findings. Discharged to home. Discharge to home with carbamazepine. My PCP, ordered MRI of c- spine and t- spine. Multiple levels of small herniations in c-spine reported. Appt with ortho physician 1/27/2020. He recommended neck injections which is pending at this point. Continue with pain 7/10 and numbness of digit 4 and 5 left hand",Not Reported,,Not Reported,Yes,2.0,Yes,N,12/23/2020,12/24/2020,1.0,PVT,XeRALTO,none,Lupus anticoagulant taking Xeralto,,solu-cortif,"['Arthralgia', 'Back pain', 'Cardiac monitoring', 'Computerised tomogram spine', 'Hypoaesthesia', 'Intervertebral disc protrusion', 'Magnetic resonance imaging spinal abnormal', 'Musculoskeletal chest pain', 'Pain', 'Pain in extremity', 'Paraesthesia', 'X-ray limb normal']",1,MODERNA,IM 986749,FL,71.0,M,"5:30 am I found husband by bed, babbling, Called 911, Had Lt Hemi Stroke. Aphasic, Rt side limp, given TPA. Sent to ICU. Recovered within 2hrs, speech, movement of extremities. lt hemi clot found on ct angiogram & mri. 2nd mri found clot busted with residual. transfered to telemetry next nite. echo unconclusive. 02 sats low, venogram done 3days later show lt dvt, lung ct wnl. ld asa & b/p meds were given. blood work to be drawn for baseline prior to anticoagulent therapy. possible d/c 9/30.",Not Reported,,Yes,Yes,4.0,Not Reported,N,01/22/2021,01/26/2021,4.0,PVT,"avorstatin, nexium, vitamin",none,none,,none,"['Angiogram abnormal', 'Aphasia', 'Blood test', 'Cerebrovascular accident', 'Computerised tomogram thorax normal', 'Deep vein thrombosis', 'Echocardiogram', 'Hemiparesis', 'Intensive care', 'Magnetic resonance imaging abnormal', 'Oxygen saturation decreased', 'SARS-CoV-2 test', 'Speech disorder', 'Thrombosis', 'Venogram']",1,PFIZER\BIONTECH,IM 986773,VA,67.0,M,"Resident was vaccinated on 12/31/20. Then on 1/14/21 he tested positive for SARS-CoV-2 on routine surveillance PCR testing. Another resident on the same hall was COVID positive on 1/11/21. Results of the PCR test were obtained on 1/16/21. He appeared asymptomatic at that time. Given his COVID positive status, all aerosol generating procedures had to be stopped. Overnight on 1/16/21 into 1/17/21, he had the onset of acute respiratory failure and was transported to the hospital. Per notes, he was put on BiPAP for several hours, but his CO2 level did not improve. Per prior advance directives completed with the resident and his two brothers, he had DNR/DNI orders. The hospital physician spoke with his brother and the decision was made to move to comfort care. He was discharged to inpatient hospice and died around 4pm on 1/18/21. This outcome does not appear to be vaccine-related, but death from COVID-19 infection is listed as a reportable event following COVID-19 vaccination.",Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/14/2021,14.0,SEN,"Acetylcysteine Solution 10 % 3 ml inhale orally two times a day BUDESONIDE 30'S,U-D,SDV UD 0.25MG/2ML AMPUL-NEB 2 ml inhale orally two times a day DIVALPROEX SOD ER 500MG TAB.SR 24H Give 1 tablet by mouth at bedtime IPRATROPIUM-ALBUTEROL O","Intermittent episodes of acute on chronic worsening of multi-factorial chronic respiratory failure with clear goals established through advance care planning. Overall, was stable in the month prior to vaccination.","1. Status post TBI as a young child resulting in a cerebral palsy like syndrome w/ ID and spastic quadriparesis, R>L 2. Seizure disorder 3. OBS/Psychiatric disorder with bipolar aspects and psychosis, better on Lithium. Symptoms well-controlled on Paxil, Risperdal and Lithium. 4. Asthmatic bronchitis w/ poor baseline respiratory function (chronic respiratory failure) and chronic cough, stable on regimen of inhaled budesonide, Duonebs and VEST therapy. 5. Complex Sleep apnea, controlled with Bi-PAP 6. GERD, stable on daily PPI. 7. Hypertension, controlled with spironolactone and terazosin. 8. CHF?, stable on spironolactone. Unable to get more records. 9. Hypothyroidism, stable on levothyroxine. 10. Dysphagia with Recurrent Aspiration (Does not want a Peg tube). Stable on puree diet and thickend liquids.",,"Quinolones, Latex, Natural rubber","['Acute respiratory failure', 'Bilevel positive airway pressure', 'COVID-19', 'Death', 'Exposure to SARS-CoV-2', 'Hospice care', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 986818,NJ,48.0,M,"aches, low blood pressure",Not Reported,,Not Reported,Yes,,Not Reported,U,01/27/2021,01/27/2021,0.0,SEN,,,,,,"['Hypotension', 'Pain']",UNK,PFIZER\BIONTECH,UN 986831,NY,77.0,M,"The patient was discharged from the facility on 1/4/2021 and was re-hospitalized on 1/8/2021, currently in the MICU. Hospital feels that current admission is due to a reaction to the COVID vaccine but not specific with the presenting symptoms.",Not Reported,,Not Reported,Yes,21.0,Not Reported,N,01/03/2021,01/08/2021,5.0,SEN,"Colace, Crestor, Proscar, Flomax, Folic Acid, Lunesta, Metformin, Miralax, Multivitamin Mylanta, Pantoprazole, Senna, Thiamine, Tylenol Valsartan","T11,T12 Compression Fracture","T2DM, Anemia, SIADH, BPH, HLD/CAD, HTN",,NKDA,"['Adverse event', 'Intensive care']",1,PFIZER\BIONTECH,IM 986857,TX,66.0,M,Extreme bouts of nausea first few days after vaccine. Estimated that patient died at home within 3-4 days after receiving the vaccine. Last phone call to daughter expressed extreme nausea and seemed to have altered mental status. Found dead by daughter on 01/04/2021.,Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PUB,Tresiba Flextouch Insulin Pen Victoza Pen Gabapentin Symtuza Sertraline HCL Anoro Inhaler Atorvastatin Risperidone Aspirin Men's Multivitamin Melatonin Pioglitazone,Uncontrolled insulin levels (high glucose),HIV COPD Diabetes Mellitus Type II Schizophrenia Psychosis Suprapubic catheter,,Fish / seafood,"['Death', 'Mental status changes', 'Nausea']",1,MODERNA,IM 986865,,50.0,F,"SOB with chest tightness and syncope episode with loss of consciousness. c/o elephant sitting on the chest. O2 92%, BP 160/ 90, AED no shock advised. EMS arrived and transported to ED",Not Reported,,Not Reported,Yes,,Not Reported,,01/29/2021,01/29/2021,0.0,UNK,,,,,,"['Chest discomfort', 'Dyspnoea', 'Loss of consciousness', 'Syncope']",1,PFIZER\BIONTECH,IM 986869,NY,79.0,F,"Patient noted with respiratory distress on 1/10/2021, transferred to hospital via 911.",Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/10/2021,7.0,SEN,"Prednisone, Miralax, Labetalol, Gas-X, Gabapentin, Folic Acid, Fluconazole, Famotidine, Eliquis, Crestor, Bactrim","Pembro associated pneumonitis and nuronal inflammation, Candida Esophagitis","HTN, MVP/Mod MR, Prior Renal Ca s/p R nephrectomy, Active Lung Ca (Prior lobectomy/SRT on pembrolizumab)",,NKA,['Respiratory distress'],1,PFIZER\BIONTECH,IM 986901,NC,33.0,F,Patient received vaccine uneventfully with no acute concerns. Left clinic and by report went out with friends. Spoke to father on phone at or around 9:00 pm. Failed to show up to work and was found dead at home. Other details pending,Yes,01/29/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,OTH,Copaxone,,Optic neuritis; asthma,,None,['Death'],1,PFIZER\BIONTECH,IM 986910,,72.0,U,L MCA stroke,Not Reported,,Not Reported,Yes,,Not Reported,,01/28/2021,01/28/2021,0.0,PHM,,,,,,['Cerebrovascular accident'],UNK,MODERNA, 986939,CA,78.0,F,Patient developed cold like s/s on the 11/12 of January 2021. By the 15th of January patient became weak with mild shortness of breath and was sent to the ER. ER sent patient home. Patient was sent back to ER on January 18th as she remained weak with shortness of breath and was unable to get out of bed. On the 19 of January the patient was sent to a SNF for rehab services in which she remains as of today. According to the patient's son the patient is doing better but still requires assist with mobility. Patient is not on oxygen.,Not Reported,,Not Reported,Yes,,Not Reported,N,01/07/2021,01/15/2021,8.0,PVT,None listed,DM type II Anemia Hyperlipidemia,DM type II Anemia Hyperlipidemia,,Propantheline,"['Asthenia', 'COVID-19', 'Dyspnoea', 'Mobility decreased', 'Nasopharyngitis', 'SARS-CoV-2 test positive']",1,MODERNA,IM 986948,GA,80.0,F,Cardiac arrest on 1/24/21 in the early morning hours then passed away on 1/25/21 around 1:51am in the hospital,Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/24/2021,2.0,PVT,"Diltiazem CD, Gabapentin, Hydroxychloroquine, Levothyroxine, Omeprazole, Oritavancin, Potassium Chloride, Propylene Glycol Eye Drops, Sertraline","alcoholic cirrhosis, thrombocytopenia, anemia, lymphedema","hypertension, hypothyroid, rheumatoid arthritis, depression, GERD",,"acetaminophen, atorvastatin, belsomra, benadryl, benzoin, cefazolin, cephalosporins, codeine, cymbalta, darvocet, dilaudid, duragesic, floxin, guaifenesin, hydrocodone, indocin, lovenox, morphine, nafcillin, oxycodone, paxil, sudafed, sulfa, vancomycin","['Cardiac arrest', 'Death']",1,PFIZER\BIONTECH,IM 986989,VA,36.0,M,"He became lethargic a few hours after 2nd vaccine. No fever, No SOB, no lower oxygen levels He was admitted to Hospital on 1/26/2021 and discharged back to us on 1/29/2021. His discharge summary stated: ""Hospital course: Patient was hospitalized. AMS was likely due to metabolic encephalopathy and dehydration and likely response to second COVID vaccination. Patient without any signs of infection with negative chest x0ray and urinalysis. His blood cultures have remained negative. Patient had CT head done which showed no acute findings. There was stable chronic changes and VP shunt. No hydrocephalus. Patient was gien IV fluid hydration. Also his hydrocortison as per recommendation from from his endocrinologist was doubled for 3 days, taking 40 mg. in the morning and 20 mg. in the afternoon. His last doubling of his dose will be this afternoon with 20 mg. hydrocortisone at 1600 hrs.........................Per the patient's father, the patient is at his baseline. At this time patient has reached maximum benefit of hospitalization and will be discharged.""",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/23/2021,01/23/2021,0.0,SEN,"Peg tube, D3, vimpat, Synthroid, Cortef, Claritin, Senekot, claritin",no,"Brain tumor hx, Hydrocephalus post VP shunt, hypopituitarism with adrenal insufficiency, dysphagia, migraines, blind L",,Trazodone,"['Blood culture negative', 'Chest X-ray normal', 'Computerised tomogram head normal', 'Dehydration', 'Lethargy', 'Mental status changes', 'Metabolic encephalopathy', 'Urine analysis normal']",2,PFIZER\BIONTECH,IM 986995,HI,43.0,M,"multiple bullae present on right ankle/foot 2 days after vaccine administration. Patient had similar event after second dose as well, with multiple bullae present on bilateral lower extremities.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,12/31/2020,01/01/2021,1.0,MIL,None,None,History of MRSA cellulitis in 2012,,No Known Drug Allergies,"['Blister', 'Blister infected', 'Cellulitis', 'Skin bacterial infection', 'Vaccine positive rechallenge']",1,PFIZER\BIONTECH,IM 986997,AR,74.0,F,"patient started complaining of leg cramps and went back to his room, then left arm pain and body pain was given some nitro, patient vomited and a headache",Not Reported,,Not Reported,Yes,,Not Reported,U,01/28/2021,01/29/2021,1.0,SEN,,,,,,"['Cardiac failure', 'Headache', 'Laboratory test abnormal', 'Muscle spasms', 'Pain', 'Pain in extremity', 'Pneumonia', 'Vomiting']",2,MODERNA,IM 987011,CA,64.0,M,"Patient received his 1st Pfizer dose on 12/17 and 2nd dose on 1/6. He gets tested for Covid-19 weekly at the nursing home and was negative 1/4 but tested positive on 1/8. On 1/15, he was admitted to the hospital with hypoxia and fever 102. O2 sat 88% on room air, 90% on 4L O2. No cough. BP dropped to systolic 90s. He was admitted for 10 days. Did not require ICU care.",Not Reported,,Not Reported,Yes,10.0,Not Reported,Y,12/17/2020,01/15/2021,29.0,PVT,"acetaminophen PRN, aripiprazole, ascorbic acid, calcium/Vit D, docusate, donepezil, famotidine, ferrous sulfate, Keppra, levothyroxine, senna, tamsulosin",none known,"Resides in nursing home Ascending thoracic aortic aneurysm, chronic. Bilateral lower extremity chronic fractures. Acute on subacute impacted fracture of the right femoral neck Hypertension Hypothyroidism Seizures Decubitus ulcers",,NKA,"['Blood pressure decreased', 'Hypoxia', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 987016,NY,30.0,U,Extensive left lower extremity/iliac DVT requiring surgical intervention. No history of thromboses. No family history of thromboses.,Not Reported,,Not Reported,Yes,,Not Reported,,01/27/2021,01/28/2021,1.0,UNK,,,,,,"['Deep vein thrombosis', 'Pelvic venous thrombosis', 'Thrombectomy', 'Ultrasound Doppler abnormal']",UNK,PFIZER\BIONTECH, 987029,NC,86.0,M,Resident passed away at 8:15 am on 1/28/21-found to be without pulse/respirations/DNR order in place.,Yes,01/28/2021,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/28/2021,1.0,SEN,Pepcid Aspirin Finasteride Stress Plus Zinc Tab Seroquel Pravastatin Sodium Amlodipine besylate Flomax,"PRESSURE ULCER OF RIGHT HEEL, STAGE 2 ATHEROSCLEROSIS OF NATIVE ARTERIES OF LEFT LEG WITH ULCERATION OF OTHER PART OF FOOT ATHEROSCLEROSIS OF NATIVE ARTERIES OF LEFT LEG WITH ULCERATION OF HEEL AND MIDFOOT","TRAUMATIC SUBDURAL HEMORRHAGE WITHOUT LOSS OF CONSCIOUSNESS, SUBSEQUENT ENCOUNTER MUSCLE WEAKNESS (GENERALIZED) UNSPECIFIED LACK OF COORDINATION FEEDING DIFFICULTIES OTHER REDUCED MOBILITY NEED FOR ASSISTANCE WITH PERSONAL CARE DIFFICULTY IN WALKING, NOT ELSEWHERE CLASSIFIED DYSPHAGIA, OROPHARYNGEAL PHASE OTHER SYMBOLIC DYSFUNCTIONS ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS ORTHOSTATIC HYPOTENSION HYPERLIPIDEMIA, UNSPECIFIED DEMENTIA WITH LEWY BODIES CHRONIC DIASTOLIC (CONGESTIVE) HEART FAILURE HYPOKALEMIA PRESSURE ULCER OF LEFT HEEL, UNSTAGEABLE CONSTIPATION, UNSPECIFIED BENIGN PROSTATIC HYPERPLASIA WITH LOWER URINARY TRACT SYMPTOMS ESSENTIAL (PRIMARY) HYPERTENSION REPEATED FALLS RETENTION OF URINE, UNSPECIFIED PRESENCE OF AORTOCORONARY BYPASS GRAFT PARKINSON'S DISEASE LOCALIZED SWELLING, MASS AND LUMP, RIGHT UPPER LIMB",,Penicillins Green Food Dye Dust Mites Aricept Namenda,"['Death', 'Pulse absent', 'Respiratory arrest']",2,MODERNA,SYR 987080,PA,80.0,M,"Client developed a mild covid infection 12/8/21 and recovered. He was admitted 12/25 with hypogycemia and mild weakness and sent home He was given his first dose of the Moderna vaccine 1/4/21 at approximately 9AM covid vaccine clinic He developed weakness the next day (1/5) prompting admission to a hospital and then transition to subacute rehabilitation briefly Work up at hospital revealed progressive respiratory failure and pneumonia requiring intubation and progressive ascending weakness and sensory loss without upper motor neuron changes. MRI : nerve root enhancement LP : protein 40, +/- 80 lymphocytes, cultures negative B 12 and B6 normal extensive CSF testing still pending campylobacter and Musk antibodies negative Neurology diagnosed likely AIDP (Guillain-Barre) and an EMG is planned for the near future. Neurology felt the cause of his GBS was likely his covid infection verses his Moderna vaccination He was treated with plasmapheresis. Client received dexamethasone, remdesivir, and zosyn and doxycycline when progressive leukocytosis and procalcitonin elevation was noted. Candida was cultured from tracheal aspirates but felt most likely d/t colonization with an option to treat further if he did not continue to improve. He is now extubated, unable to swallow and has profound weakness and distal sensory loss. He will transition to Acute rehab in the near future. Comorbidities:as described in the above section and... DM2, CKD3, HTN, DJD, BPH ( h/o prostate surgery), h/o Lumbar surgery and hernia repair, GERD, hypothyroidism, hyperlipidemia. Possible etiologies of his AIDP ( GBS) would include his recent covid infection, the Moderna Vaccine, or other undiagnosed infection. He got his flu shot 9/25 ( fluzone sanofi) so this is not likely to be the culprit",Not Reported,,Yes,Yes,20.0,Not Reported,N,01/04/2021,01/05/2021,1.0,MIL,prilosec 20 bid flonase 50 mcg nasla spray qhs glipizide 5mg ac breakfast/supper lipitor 10 mg qhs dorzolamide/timolol/ eye drops bid OU latanprost eye drops 1 qhs OU senekot bid prn loratidine 10 mg daily synthroid 125 mcg daily ipratropi,COVID infection 12/8/21,"glaucoma, diabetes, hypothyroidism, hyperlipidemia, elevated PSA, BPH, Lumbar DDD, ED",,none,"['Anti-muscle specific kinase antibody', 'Asthenia', 'CSF culture', 'Dysphagia', 'Endotracheal intubation', 'Fungal disease carrier', 'Guillain-Barre syndrome', 'Helicobacter test negative', 'Leukocytosis', 'Lymphocyte count increased', 'Magnetic resonance imaging abnormal', 'Plasmapheresis', 'Pneumonia', 'Procalcitonin increased', 'Protein total', 'Radiculopathy', 'Respiratory failure', 'Sensory loss', 'Vitamin B12 normal', 'Vitamin B6 normal']",1,MODERNA,IM 987090,WA,58.0,F,"Side effects started the same day I received the vaccine, which were reported on the V-safe app. Started with very sore arm, within 24 hours progressed to extreme fatigue, joint and body aches, loss of taste and headache. I also experienced some mild nausea. By Wednesday evening, I began to experience heart palpations which I listened to as a nurse which sounded like PVC's. I have never had this happen to me before. I assessed my vital signs and noted that as the arrhythmia progressed, my O2 sat level began to decrease and my pulse began to increase. I could hear a definite pause in my heart rhythm. Within an hour, I had chest pain in the area of my left chest over my heart which progressed into a feeling of pressure as if someone was standing with a foot on my chest. As time went on, this sensation radiated into my back at an angle from left to right. It was at this point that I had my father take me to the emergency room. When I got there, my pulse was in the low 100's and my blood pressure was 230/130. I have never had this happen to me before. I ended up on a nitroglycerin drip. My magnesium level was low and my sodium level was low normal. I was kept in the emergency room until Thursday evening then transferred to Progressive Care Unit where I remained until early evening on Friday.I was sent home on 2 different cardiac medications, Coreg and Lisinopril. I am to follow up with my PCP and a cardiologist. Both are brand new to me. I am now feeling better, but I am very reluctant to have the second covid vaccine. Also, the Hospital does not know what happened to me. (Facility where I received my Covid vaccine.)",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/15/2021,01/20/2021,5.0,PVT,"Probiotics, vitamins, Claritin prn for seasonal allergies, Tylenol as needed. Use prn for pain on occasion.",Seasonal allergies. No other known illnesses or issues. Was not diagnosed with any heart issues or blood pressure issues ever in the past. Was not taking any kind of prescription medication.,Excema since I was born. Seasonal allergies. Chronic issues with my sinuses after nasal fracture at age 16.,,"Demerol, theophylline, Ceclor, Neosporin, Vicodin. Sensitivity to prednisone and nsaids. Allergic to raw potatoes.","['Ageusia', 'Arrhythmia', 'Arthralgia', 'Blood culture', 'Blood glucose', 'Blood magnesium decreased', 'Blood thyroid stimulating hormone', 'Chest X-ray', 'Chest discomfort', 'Chest pain', 'Ejection fraction', 'Electrocardiogram', 'Fatigue', 'Fibrin D dimer', 'Headache', 'Heart rate increased', 'Metabolic function test', 'Nausea', 'Nucleic acid test', 'Oxygen saturation decreased', 'Pain', 'Pain in extremity', 'Palpitations', 'SARS-CoV-2 test', 'Scan myocardial perfusion', 'Thyroid function test', 'Troponin']",1,MODERNA,IM 987105,OK,68.0,M,"The patient noted weakness starting in the legs on January the 19th, 10 days after receiving the first dose of the vaccine. The weakness progressed to the point that he was able to ambulate only with assistance. He was seen in my neurology clinic on January 28th and his evaluation suggested an ascending, painless weakness of the legs with rapidly progressive symptoms. He was admitted to Hospital on the same day. His evaluation is consistent with Guillain Barre Syndrome and he has been started on plasmapheresis to treat the condition.",Not Reported,,Not Reported,Yes,,Yes,N,01/09/2021,01/19/2021,10.0,PUB,1) ASA 81 mg a day 2) Jardiance 25 mg daily 3)Gabapentin 300 mg TID 4) Insulin 60 units at bedtime 5) Lisinopril 10 mg daily 6) Pravastatin 80 mg daily 7) Janumet XR 50-500 two pills daily,Not applicable,Diabetes,,shellfish,"['Blood glucose increased', 'CSF protein increased', 'Central venous catheterisation', 'Gait disturbance', 'Guillain-Barre syndrome', 'Lumbar puncture abnormal', 'Magnetic resonance imaging spinal abnormal', 'Muscular weakness', 'Plasmapheresis', 'Spinal cord lipoma', 'White blood cell count normal']",1,MODERNA,IM 987115,CA,80.0,F,"Felt fine at first then everything started spinning and I started vomiting that lasted 2 hours, I was dizzy and my daughter call the ambulance and they gave me meds for nausea and started IV and at hospital they did the same and gave me something for nausea which helped.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/27/2021,01/27/2021,0.0,OTH,"Losartan-ATCZ, Level thyroxin 75 mcg tab, Estradiol 1mg, Metha",No,Soriatic arthritis,,"Demoral, Linocin and paint","['Computerised tomogram head normal', 'Dizziness', 'Magnetic resonance imaging normal', 'Nausea', 'SARS-CoV-2 test negative', 'Vertigo', 'Vomiting']",1,MODERNA,IM 987126,IA,90.0,F,Patient died. Patient had been declining in health rapidly prior to receiving the vaccine,Yes,01/29/2021,Not Reported,Not Reported,,Not Reported,,01/29/2021,01/29/2021,0.0,SEN,,,,,,['Death'],2,PFIZER\BIONTECH,IM 987154,CA,37.0,F,"The History & Physical dated Jan 25, 2021 indicates, ""Patient is a 37 Y at 34w2d presenting with leakage of fluid. She had a large gush of fluid at roughly 0600 this morning. Since that time has been leaking clear fluid intermittently. She denies contractions, no vaginal bleeding. Good FM. She denies any dysuria, hematuria, foul-smelling discharge, fevers or chills.""",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/21/2021,01/25/2021,4.0,PVT,Prenatal vitamin,Pregnant 33 weeks,None,,No known drug allergies,"['Amniorrhoea', 'Amniotic fluid index decreased', 'Amniotic membrane rupture test negative', 'Amniotic membrane rupture test positive', 'Exposure during pregnancy', 'Gynaecological examination abnormal', 'Smear vaginal normal', 'Ultrasound abdomen abnormal']",1,MODERNA,IM 987242,TX,41.0,F,"Paralysis, weakness, numbness in bilateral lower extremities. Symptoms started 1/26/2021 resulting in hospitalization. Discharged on 1/28/2021 with Out-patient physical therapy",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/25/2021,01/26/2021,1.0,PHM,"Pravastatin (10mg), Estradiol(1mg), Albuterolsulfate Inhaler",None,Asthma,,Latex & Iodine contrast,"['Asthenia', 'Facet joint syndrome', 'Hypoaesthesia', 'Intervertebral disc protrusion', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging spinal abnormal', 'Paralysis', 'Vertebral foraminal stenosis']",2,MODERNA,IM 987256,CO,77.0,F,"Had Covid vaccine Friday morning, Saturday morning at breakfast started shaking, couldn't talk. Called 911 and treated for TIA. Received blood thinners, had CT scan . MRI, and echo gram on heart. Released from hospital Monday morning, no after effects.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/15/2021,01/16/2021,1.0,PVT,"vitamin E 400iu, Pantoprazole 40mg, Primidone 100mg",Polymyalgia rheumatic,,,"Erythromycin, penicillin, sulfa, Band-aids , eggs Metronidazole topical Cream .75%","['Aphasia', 'Computerised tomogram', 'Echocardiogram', 'Magnetic resonance imaging', 'Transient ischaemic attack', 'Tremor']",1,MODERNA,IM 987301,NC,87.0,F,"My Mother was given the Covid Vaccine (1st Dose) on 12/28/2020. Later that night we received a call from the nursing facility that my Mother was having uncontrollable seizures and had to be transported to the nearby hospital. The ER doctor confirmed that my Mother had tested positive to Covid. She was treated for Covid and was on life support. A few days later we received a call that my Mother had a major stroke. She passed away on January 4, 2021",Yes,01/04/2021,Not Reported,Yes,6.0,Not Reported,N,12/28/2020,12/28/2020,0.0,SEN,Not Sure! Vaccine was given in a Nursing Facility,Previous Stroke,Not Sure,,Not aware,"['COVID-19', 'Cerebrovascular accident', 'Death', 'Life support', 'SARS-CoV-2 test positive', 'Seizure']",UNK,MODERNA, 987374,TX,78.0,M,Patient was in distress and had a Stroke ( per his wife). Ambulance called and pt was admitted to hospital.,Not Reported,,Yes,Yes,,Not Reported,U,01/27/2021,01/28/2021,1.0,PUB,,Hypertension,Hypertension,,,['Cerebrovascular accident'],1,MODERNA,IM 987400,NY,90.0,M,Patient left the pharmacy and was at his table eating. He dropped his bowl and appeared to be shaking and his eyes rolled back. He was unresponsive so his wife called 911 and an ambulance came and transported him to the Hospital. Concern at the time was either a seizure or stroke.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/26/2021,01/26/2021,0.0,PHM,"Nitrofurantoin 50mg hs, Ezetimide 10mg qd, Warfarin 3mg qd M,W,F and Warfarin 5mg qd",none listed,none listed,,nka,"['Echocardiogram', 'Electrocardiogram', 'Eye movement disorder', 'Tremor', 'Unresponsive to stimuli']",1,MODERNA,IM 987423,CA,86.0,F,"Patient received COVID vaccine #1 at 5pm. At around 9pm, she went to bathroom and noticed that she felt dizzy, shortly thereafter she noticed that her speech was slurred. Her daughter saw that her mouth was droopy and called 911. Pt took 3 baby ASA at that time as well. Patient evaluated in ED for stroke, CT/CTA normal, TPA not given. Admission diagnosis CVA vs Bell's palsy (mild). MRI consistent with changes suspect acute infarct. No arrhytmias noted. ECHO unremarkable.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/28/2021,01/28/2021,0.0,PVT,"acetaminophen 325mg 2tabs PO q6h prn fever or pain, allopurinol 100mg PO BID, anastrozole 1mg PO daily, carvedilol 12.5mg take 1/2tab PO BIDWM, vitamin D 1000 units PO daily, clobetasol 0.05% cream 1 application to affected area BID PRN leg",none noted,"Hypertension, obesity, left breast cancer s/p surgery and radiation in 2020, DVT in 2019 s/p anticoagulation (likely provoked)",,"furosemide (lip swelling), lisinopril (lip swelling)","['Acute myocardial infarction', 'Angiogram', 'Carotid arteriosclerosis', 'Cerebrovascular accident', 'Computerised tomogram head', 'Computerised tomogram head normal', 'Computerised tomogram neck', 'Dizziness', 'Dysarthria', 'Echocardiogram', 'Facial paralysis', 'Lacunar infarction', 'Magnetic resonance imaging brain abnormal', 'White matter lesion']",1,MODERNA,IM 987433,NC,58.0,F,"Chest pain, and gradual severe allergic reaction",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/29/2021,01/29/2021,0.0,OTH,"Vitamins B, C, D Buspirone, Carvedilo, Gabapentin, Dexilant, Paroxetine, Atomoxemtine, Spironolactone, Digoxin, Atorvastatin, Trazadone, Zofran, Relpax, Novolog, Basaglar, Emgality",,"Cardiomyopathy, Tachycardia, GERD, Gastroparesis, Depression PTSD, Migraines",,"Penecillin, Cephalosporin, Hydrocodone, Imitrex, Doxycyline, Levaquin, Contrast dye Peanuts, Strawberries, peppers, shellfish, fish","['Chest pain', 'Hypersensitivity']",1,MODERNA, 987469,PA,89.0,M,"emesis bright yellow in color, liquid BM, increased respirations",Yes,01/28/2021,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,SEN,,was being treated with antibiotic prednisone for hand swelling day prior,"history of bowel obstructions and diverticulosis, AFIB, Dementia, PANCYTOPENIA",,,"['Atelectasis', 'Chest X-ray abnormal', 'Computerised tomogram abdomen', 'Computerised tomogram abnormal', 'Culture negative', 'Diarrhoea', 'Lung opacity', 'Pneumonia aspiration', 'Respiratory rate increased', 'Urine analysis normal', 'Vomiting']",2,PFIZER\BIONTECH,IM 987513,VA,64.0,M,"Note Text: Resident oxygen was going down to 74% during change of shift 3-11, oxygen initiated 3liters via nasal canula per standing order want up to 84-86% NP notified, ordered Prednisone 20mg stat, Rocephin 1gram IM stat administered, Per NP statement if pt's condition worsening sent him to ER, continue monitoring pt and his oxygen going to 82% increasing distress. Notified Nurses supervisor, 911 was called pt left building at 1819 to Hospital alert oriented. Vs bp. 165/60, temp. 98.3,m pulse 109, res 22, 02. 82%. Resident father notified.",Yes,01/28/2021,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,SEN,None,UTI And PNA,"COPD , anxiety history of ETOH abuse ,thrombocytopenia",,NKA,"['Oxygen saturation decreased', 'Respiratory distress']",2,PFIZER\BIONTECH, 987533,CA,91.0,M,"The patient was observed to be lethargic on 1/29/21 at 1515. BP-80/50, P-75, RR-27, T-100.1. He was given a bolus of NS 150 mlx2. and Rocephin 1 gram IM.",Yes,01/29/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,SEN,"Insulin Lispro, Propranolol 120mg, Clopidogrel 75mg, Donepezil 10mg, Memantine 10mg, QUEtiapine Fumarate 100mg, Pantoprazole 40mg, Pramipexole Dihydrochloride 1.5mg, predniSONE 20mg, Aspirin 81mg, Atorvastatin Calcium 40mg, Insulin Glarg",See item 12,"COPD, CHF, DM, Asthma, HTN, Dementia, Depression, GERD, Parkinson",,"Dexamethasone, Versed","['Death', 'Full blood count', 'Lethargy', 'Metabolic function test']",2,PFIZER\BIONTECH,IM 988243,,80.0,M,"Weakness, pt is now in the ICU Narrative:",Not Reported,,Not Reported,Yes,,Not Reported,U,01/19/2021,01/25/2021,6.0,OTH,,,,,,"['Asthenia', 'Intensive care']",UNK,MODERNA, 988244,,71.0,M,"Weakness, dehydrated Narrative: Patient presented to vaccine clinic today for Covid-19 vaccination (Pfizer, first dose). Pt appeared weak and stated he was ""dehydrated,"" but pleasant, alert, and oriented throughout visit. After receiving the vaccination, pt still reported feeling weak. Blood pressure and pulse remained normal, but 911 was called and pt transported to the ER on campus.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/27/2021,01/27/2021,0.0,OTH,,,,,,"['Asthenia', 'Dehydration']",1,PFIZER\BIONTECH,IM 988245,,93.0,M,"93 y/o with complex medical history (severe COPD on oxygen, diastolic CHF, CKD3, myelofibrosis, marginal zone lymphoma of spleen with recent progression and no active treatment, chronic anemia, afib, CAD, pulmonary artery hypertension, h/o bladder cancer, hypertension, hypothyroidism, h/o bilateral PE, sick sinus syndrome s/p pacemaker, h/o Hodgkin's disease). Has had multiple hospitalizations over the last 3 months for dyspnea, most recently in 12/2020. Enrolled in palliative care. Has had multiple transfusions (most recently 01/13/21) for his chronic anemia due to myelofibrosis, and recently started on darbepoetin. No documented history of anaphylaxis to medications or prior vaccinations. He received COVID19 vaccine (Moderna) on 01/16/21. He passed away suddenly at home on 01/17/21. Symptoms: & cardiac arrest Treatment:",Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,,01/16/2021,01/17/2021,1.0,OTH,,,,,,"['Cardiac arrest', 'Sudden death']",2,MODERNA, 988246,FL,77.0,M,"Narrative: See ""Other Relevant History"" in Section 6 above Symptoms: ElevatedLiverEnzymes & death, pneumonia, afib Treatment:",Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,,12/22/2020,01/26/2021,35.0,OTH,"acetaminophen, albuterol/ipratropium, amlodipine, ascorbic acid, atorvastatin, baclofen, buspirone, calcium carbonate with vitamin D, cholecalciferol, dexmedetomidine, diltiazem, docusate, esomeprazole, famotidine, fentanyl, fluticasone, ga",,,,,"['Alanine aminotransferase decreased', 'Aspartate aminotransferase decreased', 'Atrial fibrillation', 'Bilirubin conjugated increased', 'Blood alkaline phosphatase normal', 'Blood bilirubin increased', 'Blood creatinine increased', 'Blood urea decreased', 'Blood urea increased', 'Death', 'Pneumonia', 'Protein albumin ratio increased', 'SARS-CoV-2 antibody test negative', 'SARS-CoV-2 test negative', 'White blood cell count increased']",3,PFIZER\BIONTECH, 988286,,62.0,F,"Headache, HYPERtension, FATIGUE Narrative: PATIENT HOSPITALIZED OVERNOC w/HTN urgency. patient later seen by PCP endorsing improvement of symptoms. pt further endorsed feeling lightheaded with vaccination # 1. pt also with c/o increased burping.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/22/2021,01/22/2021,0.0,OTH,,,,,,"['Eructation', 'Fatigue', 'Headache', 'Hypertension', 'Hypertensive urgency']",2,PFIZER\BIONTECH,IM 987636,GA,78.0,M,Legs started swelling and shortness of breath Thursday January 21 2021 Was rushed to hospital with kidney failure and fluid build up around lungs and entire body Blood pressure dropped and had multiple organ failure,Yes,01/28/2021,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/21/2021,3.0,PHM,"Insulin, blood pressure medication",Diabetes,,,None,"['Blood pressure decreased', 'Dyspnoea', 'Fluid retention', 'Multiple organ dysfunction syndrome', 'Peripheral swelling', 'Pulmonary oedema', 'Renal failure']",1,PFIZER\BIONTECH,SYR 987640,FL,72.0,F,"Severe pain in arm and shoulder, feels like a fracture. Unable to move arm without severe pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,OTH,Omeprazole -- 40MG; Losartan -- 50MG; Simvastatin --40MG; Synthroid --75MCG; Metoprolol -- 25MG; Pregabalin -- 25MG Centrum Silver Multi Vitamin; Vitamin E; Calcium w/D; Citrucel; Probiotic; Biotin,None,Osteoporosis; GERD; Hypothyroidism; High Blood Pressure; Chronic Back Pain,,None,"['Pain', 'Pain in extremity']",1,MODERNA,IM 987663,,85.0,M,Died,Yes,01/10/2021,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/10/2021,10.0,PVT,Prescription blood pressure medication,None,For a year he had a catheter as part of treatment of a prostrate issue without surgery.,,None,['Death'],UNK,PFIZER\BIONTECH, 987687,MI,58.0,M,"Severe pain in injection arm, profuse sweating on second day. A lot of vomiting causing me pass out out and be taken to the hospital via ambulance.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/23/2021,01/24/2021,1.0,PVT,,,,,,"['Hyperhidrosis', 'Laboratory test', 'Loss of consciousness', 'Pain in extremity', 'Vomiting']",2,PFIZER\BIONTECH,IM 987693,TN,58.0,F,I have tinnitus before the vaccine that was under control in right ear . After second vaccine my ears both began feeling full with pressure and buzzing in ear became much louder . MD prescribed cefdiner antibiotic on 1/26/21 and then prednisone dose pack on 1/27/21. The fullness in the ears started 1/25/21,Not Reported,,Not Reported,Not Reported,,Yes,N,01/21/2021,01/30/2021,9.0,PUB,Triamterene HCTZ 37.5 to 25 mg Temazepam 50 mg Amitriptyline Allegra 180 Vitamin D 3,Asthma,Asthma,Arm sore from first vaccine given on 12/23/20,NKA,"['Condition aggravated', 'Ear discomfort', 'Tinnitus']",2,MODERNA,SYR 987737,MI,65.0,M,"On 1-23-21, less than 24 hours after the vaccine was administered, the person developed facial numbness, slurred speech, memory difficulty. BP: 200/100. This occurred again on day 3. Hospitalized a total of 6 days. Discharged home on 1-29-21. Diagnosis: TIA, possible seizures. No history of either. Positive history for controlled hypertension.",Not Reported,,Yes,Yes,6.0,Not Reported,Y,01/22/2021,01/23/2021,1.0,PVT,,,,,,"['Blood pressure increased', 'Computerised tomogram normal', 'Dysarthria', 'Electroencephalogram normal', 'Hypoaesthesia', 'Laboratory test normal', 'Magnetic resonance imaging normal', 'Memory impairment', 'Transient ischaemic attack', 'Vitamin B12 decreased']",1,PFIZER\BIONTECH,SYR 987748,FL,69.0,F,a few days after my covid shot my right should be to hurt. I am left handed and have had a torn rotor cuff in my left arm and now my right arm where the shot was given is having the same painful symptoms as a torn rotor cuff. Before the shot i had absolutely no problems with my right arm,Not Reported,,Not Reported,Not Reported,,Yes,N,01/22/2021,01/24/2021,2.0,OTH,levothyroxine 100 mcg burpropion 150 mg calcium w/d multi vitamin,no,none,,gluten,"['Arthralgia', 'Injection site pain']",1,PFIZER\BIONTECH,UN 987751,AZ,74.0,F,"My mom received her vaccine at her assisted loving facility. I talked to her that evening and she felt good. No pain. No complaints of anything. Overnight she had respiratory distress. Per EMS her O2 seats were in the 60s . She stoped breathing en route. Currently on a vent, pressers. COVID test at the hospital is negative.",Not Reported,,Yes,Yes,,Not Reported,N,01/28/2021,01/28/2021,0.0,SEN,Tylenol ES,No acute illness,HTN HLP CAD,,None,"['Mechanical ventilation', 'Respiratory arrest', 'Respiratory distress', 'SARS-CoV-2 test negative']",UNK,MODERNA,IM 987789,MI,85.0,M,"REC'D CALL FROM PT'S DAUGHTER, HER FATHER WAS VACCINATED ON 1/22/21, WOKE UP 1/23/21 WAS SHORT OF BREATH AND DIZZY. PT PRESENTED TO ED OF LOCAL HOSPITAL AND WAS ADMITTED, PT PASSED ON 1/25/21. DAUGHTER STATES THAT FAMILY AND DOCTORS AGREE THAT THE VACCINE DID NOT CONTRIBUTE TOWARDS PT'S DEATH, BUT FELT IT NEEDED TO BE REPORTED. PT'S DAUGHTER CONTACTED THIS RN AT LOCAL HEALTH DEPARTMENT TO REPORT TO VAERS.",Yes,01/25/2021,Not Reported,Yes,2.0,Not Reported,N,01/22/2021,01/23/2021,1.0,PVT,UNKNOWN,UNKNOWN,UNKNOWN,,UNKNOWN,"['Death', 'Dizziness', 'Dyspnoea']",1,PFIZER\BIONTECH,SYR 987877,MI,86.0,M,"REC'D CALL FROM PT'S SON, PT HAS BEEN ON HOSPICE CARE AND PASSED 1/26/21. DOES NOT BELIEVE THIS IS RELATED TO VACCINE ADMINISTRATION, BUT WANTED TO REPORT TO US.",Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/26/2021,12.0,PUB,UNKNOWN,PT WAS ON HOSPICE CARE AT TIME OF VACCINATION,UNKNOWN,,PCN,['Death'],1,MODERNA,IM 987914,IA,33.0,F,"Received COVID vaccine on Friday afternoon, 1/22, developed some slight abdominal cramping 1/24 and 1/25, had severe abdominal and back pain resulting in miscarriage evening of 1/25. Estimated date of delivery: August 27, 2020 Also had known subchorionic hematoma, diagnosed on 1/19 via ultrasound at physician's (OBGYN) office",Not Reported,,Yes,Not Reported,,Not Reported,N,01/22/2021,01/25/2021,3.0,PVT,"Zyrtec, 200 mg Progesterone","Subchorionic hematoma, diagnosed by ultrasound on 1/19/2021",GERD,,None,"['Abdominal pain', 'Abortion spontaneous', 'Back pain', 'Blood test', 'Exposure during pregnancy', 'Ultrasound scan']",1,PFIZER\BIONTECH,IM 987994,FL,65.0,M,"Patient presented to the ED the morning after receiving his first COVID-19 vaccine with a chief complaint of tongue swelling and difficulty speaking. Patient received his vaccine at approximately 12:00pm and presented to the ED around 08:00am. Isolated tongue swelling and abnormal speech was appreciated on exam. Patient was given famotidine, methylprednisolone, epinephrine, and diphenhydramine in the ED. Patient was then admitted to the medical ICU for monitoring.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/29/2021,01/30/2021,1.0,PVT,"Amlodipine, atorvastatin, Vitamin D3, clopidogrel, cyanocobalamin, lisinopril, venlafaxine.",,"Hypertension, COPD, depression, hyperlipidemia",,No known allergies.,"['Intensive care', 'Speech disorder', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 988061,MI,82.0,M,"Chills, fever, fatigue from day of onset. Currently in ICU for ARDS",Not Reported,,Yes,Yes,,Not Reported,N,01/11/2021,01/11/2021,0.0,PVT,"Moduretic, ASA 81mg, glipizide, losartan, metformin, potassium chloride, potassium citrate",None,"CKD stage 2, DM2, essential hypertension, hyperlipidemia, obesity (BMI 27.3)",,None,"['Acute respiratory distress syndrome', 'C-reactive protein', 'Chest X-ray abnormal', 'Chills', 'Computerised tomogram thorax abnormal', 'Fatigue', 'Fibrin D dimer increased', 'Intensive care', 'Lactic acidosis', 'Lung opacity', 'Procalcitonin', 'Pulmonary congestion', 'Pulmonary embolism', 'Pulmonary oedema', 'Pyrexia', 'Respiratory tract congestion', 'Troponin', 'White blood cell count']",1,MODERNA, 988065,NC,30.0,F,"The patient came in to get her 2nd dose of COVID-19 vaccine. The patient is pregnant and currently enrolled in 2 trials. She also had COVID-19 back in July. The patient received Pfizer vaccine today (1/30/2021) as this was the only vaccine being given today. Upon administration, it was noticed that the patient had actually received Moderna first (12/30/2020 at 9:10 a.m.) and should have received Moderna again. The nurses stated that they informed the patient that we are giving Pfizer vaccine today. The patient disputed this and said she wasn?t told this information. However, the manufacturer and lot# were recorded on her vaccination card and this was missed before the patient got her vaccination. In the midst of explaining about the vaccines the patient told us that she rescheduled her own appointment from Wednesday, Jan. 27 to today Jan. 30. Apparently this was a glitch in our scheduling system and the problem has been fixed. Patient was advised to contact her OB/GYN and clinical trial coordinators. We also encouraged her to call V-Safe to report the administration error.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/30/2021,01/30/2021,0.0,PUB,Unknown,Unknown,Unknown,,Unknown,"['Exposure during pregnancy', 'Interchange of vaccine products']",2,PFIZER\BIONTECH,IM 988076,NY,59.0,M,"On day 04 After receiving the 2nd Covid 19 Pfizer vaccine, I experienced a deep pain in my upper inner right thigh around 0600 am of the 16th of January. At the same time my calf muscle of that same right leg was in pain. I thought it to be muscular pain as I was told by the reading material regarding symptoms of the covid 19 vaccine there could be aches an pains attributed to the 2nd shot. I used a deep heating rub on both areas of my right leg and put heat on them to treat the soreness. This occured over the next few days feeling this pain in my right leg and treated the same way applying heat. Within about 24 hours of the pain in my legs I started experiencing a shortness of breath while walking up and down st. On day 04 After receiving the 2nd Covid 19 Pfizer vaccine, I experienced a deep pain in my upper inner right thigh around 0600 am of the 16th of January. At the same time my calf muscle of that same right leg was in pain. I thought it to be muscular pain as I was told by the reading material regarding symptoms of the covid 19 vaccine there could be aches an pains attributed to the 2nd shot. I used a deep heating rub on both areas of my right leg and put heat on them to treat the soreness. This occured over the next few days feeling this pain in my right leg and treated the same way applying heat. Within about 24 hours of the pain in my legs I started experiencing a shortness of breath while walking up and down stairs as part of my daily activities. The symptoms of shortness of breath only seemed to appear when I was on any form of extended walking activity or physical movements or exercise this would of have been starting around the 17th of January. The right leg pain was masked by the heating rub while the shortness of breath continued for the next few days. On the 19th of January, I went to an Urgent Care Facility at 0800 am to see a Medical professional to discuss my symptoms I was previously experiencing and to figure out why I was having a shortness of breath and the pain in my right leg. The on staff Physician's Assistant had a Nurse conduct a Covid 19 Rapids test (negative) and a second swab was administered and sent to the Lab. Which produced a (negative for Covid 19) on the 20th of January. An Xray was not taken to determine my shortness of breath. The Dr listened to my lungs and heart, though I did let the PA know I had received both Pfizer shots and when they were administered. I was carrying My Shot record for the vaccine with the dates and lot number. He didnt appear to be interested in further diagnosis and made sure I had the paperwork to track the results of my Covid swab sent to the lab. The visit was completed and I was released to go back to work/home. I carried on the symptoms of the shortness of breath from the 19th of January to the 22nd of January monitoring my O2 (oxygen levels) with a pulse oximeter. They ranged from 90-93. On the evening of the 22nd of January I was becoming very uncomfortable with my breathing climbing the stairs in my home and monitored my O2 readings with the oximeter on my finger when walking upstairs and they dropped down to 60-65. My wife drove me to the emergency room at Hospital. I walked into the ER and checked myself in for shortness of breath and leg pain in my right leg. I was admitted into the emergency room and put on 15 litres of oxygen. The emergency room Dr ordered a chest Xray, Cat Scan of my chest and heart and a sonogram of my right leg. The testing results came back with a noted large pulmonary emboli on my lungs/heart area and blood clots throughout my right leg (right lower extremity DVT). Surgery was performed to remove the pulmonary emboli and I was put on a Heprin Drip to thin out my blood for the remaining clots in my chest and my right leg. The attending physician ordered a T.E.E. (transesophageal Echocardiogram) to observe my heart functions. I was told the TEE did not demonstrate any further recommend surgeries. I was administered a test for my cardio and heart functions prior to my discharge on 27 January 2021. I was prescribed Eloquis for maintenance medication to be monitored by followup visits to my cardiologist and Hemotologist within the next few weeks. I have not family or personal history of Blood Clots. I do perform administrative duties as part of my job, which requires sitting and working on a computer. Note however I move around very often during a work day and operate a farm tractor and have an active life style. I have not recently had any extended trips more than 2 hours nor have I flown within the past year or so.",Not Reported,,Yes,Yes,5.0,Yes,Y,01/13/2021,01/16/2021,3.0,WRK,"20 mg Omeprazole 1x day, 20 mg Lisinopril 1 x day, 5 mg Amlodo; Amlodopine 1 x day, 12.5 mg Carvedilol 2 tabs 2 x day, .4mg Tamsulosin 1 x day, Advair diskus 500/50 (1) puff twice a day. CPAP machine at night set to 6.",None,"Acid Reflux, sleep apnea, hypertension",,None,"['Angiogram', 'Blood test', 'Chest X-ray abnormal', 'Deep vein thrombosis', 'Dyspnoea', 'Dyspnoea exertional', 'Echocardiogram', 'Myalgia', 'Oxygen saturation decreased', 'Pain in extremity', 'Pulmonary embolism', 'SARS-CoV-2 test negative', 'Thromboembolectomy', 'Thrombosis', 'Ultrasound Doppler abnormal', 'Ultrasound scan abnormal']",2,PFIZER\BIONTECH,IM 988095,NY,79.0,M,"BRAZO, HOMBRO, TOBILLO, PECHO, CUELLO, PARTE DE DONDE LA CABEZA SE JUNTA CON EL CUELLO UN DOLOR COMO CUANDO LE PONEN LAS INJECCIONES DE VITAMINAS. HE PERDIDO LA FUERZA. NO HE PERDIDO SENSIBILIDAD PERO NO HAY FUERZA MUSCULAR. CUANDO VIRO EL CUELLO ME DUELE. EL PIE SE HA MEJORADO, PERO EL TRONCO DEL MULO ME DUELE. EL PECHO ME DUELE CUANDO TOSO. NO TENGO NINGUNA FUERZA NI MOBILIDAD EN MI BRAZO IZQUIERDO Y UN DOLOR ""CANSADO"" EN EL CUELLO.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/15/2021,01/16/2021,1.0,PVT,MELOXICAM 15MG; LOSARTAN 50MG; ESOMEPRAZOLE 40MG; FINASTERIDE 5MG; AMLODIPINE 10MG; ESCITALOPRAM 5MG; TAMSULOSIN 0.4MG; SUCRALFATE 1MG,NINGUNA,NINGUNA,,NINGUNA,"['Arthralgia', 'Asthenia', 'Chest X-ray', 'Chest pain', 'Computerised tomogram abnormal', 'Coronary artery disease', 'Cough', 'Headache', 'Injected limb mobility decreased', 'Laboratory test', 'Mobility decreased', 'Neck pain', 'Pain', 'Pain in extremity', 'Sensory loss']",1,MODERNA,IM 988252,PA,29.0,F,"""Pfizer-BioNTech COVID-19 Vaccine EUA"" I received my 2nd dose of the Pfizer COVID-19 vaccine on Jan. 20th, 2021. On Jan. 21st, 2021, I woke up feeling feverish. I went to use the bathroom, and after washing my hands I walked towards the bathroom door and felt light-headed and dizzy. Suddenly, I passed out and hit my head and upper neck on the tile floor. My parents heard the sound of my fall and luckily rushed to the bathroom. They found me lying unconscious on the floor with my eyes rolled up for what felt like more than a minute. I regained consciousness on my own, and I drank water with a bit of sugar and salt mixed in. I felt too weak to get up and walk, and the back of my head and upper neck were in pain. I told my parents to call 911 as I wanted to make sure that there was no serious damage to my brain or neck area. I went to the local hospital in an ambulance. I was taken to the emergency room: Vitals were done and my temperature ranged from then was 99.5-101F and my heart rate was high- it stayed around 112 bpm for some time I was given 2 L of IV Saline Fluids EKG result: no clinical abnormalities CT head/neck/spine: negative 2 different types of COVID-19 tests: results were both negative Bloodwork: CBC/BMP/D-dimer: no clinical abnormalities Chest Xray: negative 2D- doppler ultrasound: negative Holter monitor: negative for irregular heart rhythm I was discharged the same day around 4:30pm",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/20/2021,01/21/2021,1.0,PVT,Centrum Multivitamin,None,None,,None,"['Asthenia', 'Chest X-ray normal', 'Computerised tomogram head normal', 'Computerised tomogram neck', 'Computerised tomogram spine', 'Dizziness', 'Electrocardiogram ambulatory normal', 'Electrocardiogram normal', 'Eye movement disorder', 'Fall', 'Fibrin D dimer normal', 'Full blood count normal', 'Head injury', 'Headache', 'Heart rate increased', 'Loss of consciousness', 'Metabolic function test normal', 'Neck injury', 'Neck pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Ultrasound Doppler normal']",2,PFIZER\BIONTECH,IM 988255,,81.0,M,Recurrence of symptomatic paroxysmal AFib Narrative:,Not Reported,,Not Reported,Yes,,Not Reported,N,01/27/2021,01/28/2021,1.0,OTH,,,,,,"['Atrial fibrillation', 'Condition aggravated']",2,PFIZER\BIONTECH,IM 988262,,60.0,M,Dizziness diplopia Narrative:,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/12/2021,01/16/2021,4.0,OTH,,,,,,"['Diplopia', 'Dizziness']",1,PFIZER\BIONTECH,IM 988266,AZ,50.0,F,"I contracted Covid-19 approx 1 week after getting the vaccine. I do not believe that the vaccine gave me Covid. But, I believe that it made me more susceptible. The week of receiving the vaccine my daily schedule was approx 80-90% covid patients. I do Physical Therapy in a hospital with them and spend approx 30 min or more with each patient. If I or my facility would have been given a warning my schedule could have been different. Our therapy team might have been allowed to change the individual patient load depending on when each person recvd the vaccine. I am older and have a few underlying conditions so I was concerned about contracting it. Luckily I was able to stay home. *main take-away is that health care facilities should have been given more information and guidance on how to change schedules to best protect the employees if the vaccine causes a reduction in immunity right after. I asked the question in a Facebook group for therapists and many of them did get covid right away. Coincidentally? Could be. But for sure something to keep track of.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/05/2021,01/12/2021,7.0,OTH,"Vit: C, D3, B12, iron, magnesium, Rx: Levothyroxine, Duloxetine, Gabapentin, cyclobenzaprine, progesterone, Estrogen/Testosterone gel OTC: Tylenol, Zyrtec, baby asprin",None,Hashimoto?s Hypothyroidism OSA,,"EDD, EDTA, celebrex, ranidatine , nystatin","['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,SYR 988270,TN,90.0,M,Narrative: Symptoms: & death Treatment:,Yes,01/14/2021,Not Reported,Not Reported,,Not Reported,,12/28/2020,01/14/2021,17.0,OTH,,,,,,['Death'],UNK,MODERNA, 988280,,78.0,M,"SOB, Fatigue, weakness Narrative: F: Telephone call: Pt's wife called and said that patient is in the hospital- He went into hospital on 1/24/21. He had the Covid injection here at facility on 1/22/21@0945. He was feeling fine till approximately 1800 that night. His symptoms included the following: chills- fever of 102- he took Motrin 11PM on 1/22. On 1/23- @0200 fever was 99 on 1/23- he was fatigued feverish was back @ 101 degrees. He had no appetite all day. He was tired- weak- trouble breathing with SOB- Call was made to to this facility at 0230 but there was no answer. On 1/24/21- 0230AM patient could not breath and 911 was called. The EMT came- Sao2 was 65 %- couldn't walk- very short of breath. He was taken to hospital where he has been since. He was Dx with Pneu and placed on IV/ABT. Covid test was done and was negative at hospital. He has been on Oxygen since. His wife was very tearful. Family says that he may need O2 at home and a HHA.",Not Reported,,Yes,Yes,,Not Reported,N,01/22/2021,01/22/2021,0.0,OTH,,,,,,"['Asthenia', 'Chills', 'Decreased appetite', 'Dependence on oxygen therapy', 'Dyspnoea', 'Fatigue', 'Gait inability', 'Pneumonia', 'Pyrexia', 'Respiratory arrest', 'SARS-CoV-2 test negative']",1,MODERNA,IM 988287,IL,23.0,F,"I received my second dose of the Moderna COVID vaccine at approx. 10:40 AM on Friday, January 29 at clinic. By 12:00 PM, I noticed that I developed facial swelling, which was most significant around my eyes, and I felt lethargic. Between 12:00 PM and 2:00 PM, I developed hives on my neck, chest, stomach, and arms, which prompted me to take 1/2 of a dose of 25mg Benadryl. Nonetheless, the symptoms persisted and I began to experience dizziness and tightness in my throat around 4-5 PM, which was when I was advised by a nurse to go to the emergency room for treatment. I arrived at Hospital's Emergency Department around 6:00 PM and I was treated for ""Possible Allergic Reaction Major."" I received diphenhydrAMINE (BENADRYL) injection 50 mg, famotidine (PF) (PEPCID) injection 20 mg, methylPREDNISolone sodium succinate (PF) (SOLU-MEDROL) injection 125 mg, sodium chloride 0.9 % iv bolus, and acetaminophen (TYLENOL) tablet 650 mg. I was discharged after 10:00 PM and sent home with a prescription for predniSONE 20 mg and famotidine 20 mg. My facial swelling and hives have gone down but neither have completely resolved since being discharged. I am also experiencing full body aches and fatigue at this time (3 PM on Saturday, January 30).",Not Reported,,Yes,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,PVT,"Vyvanse (ADHD), doxycycline (acne)",None,None,,No allergies,"['Blood test', 'Dizziness', 'Fatigue', 'Lethargy', 'Pain', 'Swelling face', 'Throat tightness', 'Urticaria']",2,MODERNA,IM 988325,MI,60.0,F,Onset of Petechial/purpural rash along BLE starting in thighs B/L with spread to abdomen and BUE. Probable Type III Hypersensitivity vs vasculitis. Came to hospital 01/28/2021. Treated with PO steroids 60 mg PO prednisone with rapid improvement. Testing still pending.,Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/06/2021,01/26/2021,20.0,PVT,Hydrochlorothiazide last taken 2 weeks prior to vaccine administration Levothyroxine Albuterol as needed Daily multivitamin,None.,"Anxiety, HLD, HTN, hypothyroidism, rosacea, liver steatosis secondary to obesity Migraine, impaired fasting glucose without diagnosis of T2DM, obesity with BMI 40.5",,Codeine and morphine intolerance Sulfa antibiotics-prior hives seen on administration in her 20s,"['Biopsy skin', 'Petechiae', 'Purpura', 'Rash', 'Type III immune complex mediated reaction', 'Vasculitis']",1,MODERNA,IM 988343,MI,27.0,M,"Jaundice, abdominal pain, body aches. headache,nausea - started 1/24/21. HGB 6.8, low haptoglobin Pt has a had a history of hereditary stomatocytosis. When the patient had the shingles vaccine 5/2019,he had a similar reaction. Pt is requiring IV pain medications.",Not Reported,,Not Reported,Yes,7.0,Not Reported,N,01/22/2021,01/24/2021,2.0,PVT,"Albuterol Inh, Xanax 0.25 mg, Zytrec 10mg, Hibiclenz, vibramycin 100 mg, folic acid, ibuprofren, Airborne (not recently taken), MVI,sertraline",none listed,"Hereditary stomatocytosis aplastic crisis gynecomastia splenomegaly migraine, seasonal allergies",shingrix,Amoxicillin Penicillin azithromycin,"['Abdominal pain', 'Blood bilirubin normal', 'Haemoglobin decreased', 'Haptoglobin decreased', 'Headache', 'Hepatomegaly', 'Jaundice', 'Metabolic function test', 'Nausea', 'Packed red blood cell transfusion', 'Pain', 'Portal hypertension', 'Splenomegaly', 'Ultrasound abdomen', 'Ultrasound abdomen abnormal', 'White blood cell count']",1,PFIZER\BIONTECH,ID 988369,IL,82.0,M,aspiration pneumonia/death,Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/21/2021,2.0,UNK,Carvedilol Citalopram Phenytion Olanzapine,,diabetes gastroparesis MitraClip,,Penicillin,"['Death', 'Pneumonia aspiration']",1,MODERNA, 988373,IN,31.0,M,"High blood sugar, fever, headache, body aches",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,"Lisinopril, metoprolol, pravastatin, amlodipine, Lyrica, insulin",None,"Type 1 diabetes, gastroparesis, high blood pressure, high cholesterol",,"Metformin, Cipro, Levaquin, Milk, Eggs","['Blood glucose increased', 'Full blood count', 'Headache', 'Metabolic function test', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 988402,FL,54.0,M,"9 days after the vaccination, I had fever 102-103 F with chill, malaise, paresthesia and body ache requiring taking Tylenol alternate with Advil every three hours. I tested for COVID-19 (PCR) and it was negative. Fever continued. On day 6, I went to urgent care center and was tested again with PCR for SAR-CoV-2 virus. The result was again negative. On day 7, I started coughing so I went to Hospital ER and was admitted. Chest X-ray and CT scan of chests showed pneumonia. The COVID-19 PCR test was again done and was negative. Respiratory panel PCR was negative. Mycoplasma titer was negative. I was given steroid and fever improved. I continued to cough until now (1/30/2021)",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,12/17/2020,12/26/2020,9.0,PVT,None of,None,Hypercholesterolemia,,None,"['C-reactive protein increased', 'Chest X-ray abnormal', 'Chills', 'Computerised tomogram thorax abnormal', 'Cough', 'Lung infiltration', 'Malaise', 'Mycoplasma test negative', 'Pain', 'Paraesthesia', 'Pneumonia', 'Pyrexia', 'Respiratory viral panel', 'SARS-CoV-2 test negative', 'Serum ferritin increased']",1,PFIZER\BIONTECH,IM 988497,NJ,41.0,F,Encephalitis - most likely recurrent autoimmune,Not Reported,,Not Reported,Yes,3.0,Yes,N,01/09/2021,01/13/2021,4.0,PHM,Lexapro 10 mg Vitamin D Multivitamin,None,None,,Latex Pencillin,"['Angiogram', 'Computerised tomogram', 'Electroencephalogram', 'Encephalitis', 'Lumbar puncture', 'Magnetic resonance imaging brain']",1,MODERNA,SYR 988528,CA,70.0,F,"Acute fainting episode during the night following the day of the vaccine. Hit my head on the stone floor and was unconscious. Taken to ER in ambulance. All diagnostics were normal and after blood pressure returned to normal and getting 4 staples in my scalp I was released. Since coming home I have been very ill with weakness, vertigo, nausea, and headache.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/27/2021,01/28/2021,1.0,OTH,"Calcium, vitamin D, essential fatty acids",None,None,,none,"['Asthenia', 'Blood pressure decreased', 'Blood test', 'Computerised tomogram head', 'Electrocardiogram abnormal', 'Head injury', 'Headache', 'Heart rate decreased', 'Loss of consciousness', 'Malaise', 'Nausea', 'Skin laceration', 'Spinal X-ray', 'Suture insertion', 'Syncope', 'Urine analysis', 'Vertigo']",1,PFIZER\BIONTECH,SC 988533,MT,89.0,F,"Resident per her usual health when dietary staff were into apartment at 0730 with her breakfast. Resident conversing, appropriate, with no focal deficits with ADL. Resident baseline with mild confusion, generalized weakness, using a 4 wheeled walker when ambulating. Med care manager into room at 0830 with am medications. Resident was lying partially on her bed, non responsive. EMS was called immediately and resident was transported to Hospital ER. Wellness nurse was notified later that resident was admitted for rule out CVA.",Not Reported,,Yes,Yes,,Not Reported,U,01/29/2021,01/30/2021,1.0,SEN,Cerovite senior tablet- 1 daily; Plavix 75 mg daily; Digoxin 125 mcg daily; Furosemide 20 mg daily; Hair Skin and Nails caplet- 1 daily; Levothyroxine 25 mcg daily; Magnesium 250 mg daily; Metoprolol ER 25 mg daily; Stimulant Laxative Plus-,No acute illnesses,"Coronary Artery Disease, Atria Fibrillation; Muscle Weakness; GERD without esophagitis; long term use of anticoagulants; hyperlipidemia; diffuse cystic mastopathy; viral hepatitis complicating the peurperium; essential hypertension; impaired fasting glucose; low back pain.",,"Fentanyl, Midazolam, Rosuvastatin, Statins","['Asthenia', 'Cerebrovascular accident', 'Confusional state', 'Unresponsive to stimuli', 'Walking aid user']",1,PFIZER\BIONTECH,SYR 988537,OH,79.0,M,"Patient rec'd vaccine on 1-25-2021. Patient woke up on 1-26-2021 feeling so bad with joint stiffness and trouble breathing, he called 911. He was taken to Hospital where he was admitted. He says by 1-27-2021 he was feeling much better with each passing hour. He was discharged on 1-27-2021. Then on 1-28-2021 he noticed a red and very itching rash at the injection site and all across his back.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/25/2021,01/26/2021,1.0,PHM,,,Congestive Hearth Failure and was hospitalized with COVID19 in Nov 2020.,,"Statins, Cipro and Torsemide","['Dyspnoea', 'Feeling abnormal', 'Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Joint stiffness', 'Rash', 'Rash erythematous']",1,MODERNA,IM 988539,TN,83.0,F,"Shortness of breath, rapid heart, nervous, oxygen dropped I had to rush her to Emergency Room at hospital. She was placed on oxygen, giving multiple breathing treatments, rocephine, and steriods.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/27/2021,01/28/2021,1.0,OTH,Carbidopa/Levadopa Ropinrole HCL Gabapentin Vitamin B 6 Vitamin D 3 Calcium Citrate Sertailine HCL Ferrous Gluconate Atenolol Ipratropium Bromide Nasal Solution,,Parkinson's Disease,,Doxycycline,"['Blood gases', 'Blood test', 'Computerised tomogram', 'Dyspnoea', 'Heart rate increased', 'Nervousness', 'Oxygen saturation decreased']",1,PFIZER\BIONTECH,SYR 988550,AK,37.0,F,Developed appendicitis within 2 days of vaccination,Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/26/2021,01/28/2021,2.0,MIL,Wellbutrin atarax,,Anxiety,,Sulfa,['Appendicitis'],UNK,MODERNA,IM 988676,WA,39.0,F,"G4P1 prior uncomplicated pregnancy 35 +1 weeks pregnant EDD 27 Feb. That night I went to drink and liquid came out my mouth spontaneously, my left side of face had lost normal wrinkles on forehead, eyebrow wouldn't lift, eyelid wouldn't blink, cheek couldn't puff, lips didn't smile. Next day (1) slight cheek numbness noted- resolved Day3 . Day 2 slight difficulty articulating words. Night 3 intermittent sharp outer ear and mastoid area pain duration 30min and at different times intermittent pulsatile heartbeat and whistling sound 10 min or less. Day 4 & 6 notable improvements in cheek ability to puff- not fully resolved though. Day 5 eyelid movement - not fully resolved though. Day 6: less difficulty articulating. Day 1: Spoke to OB office nurse- offered steroids which I declined & spoke to PCP recommended go to ED, which I declined, I'm a family physician and had otherwise normal Cranial nerve testing and no other neurological changes- seems fully consistent with Bell's palsy. Day 3 had co-worker physician use otoscope - normal exam bilaterally.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/11/2021,01/24/2021,13.0,PVT,Prenatal vitamin 1 daily Ferrous sulfate 325mg 1 dialy Colace 100mg 1 twice daily,3rd trimester hemorrhoids used hydrocortisone suppository 100mg every 8 hours as needed the week before vaccination,None,,None,"['Dysarthria', 'Dysphagia', 'Exposure during pregnancy', 'External ear pain', 'Eyelid function disorder', 'Facial paralysis', 'Hypoaesthesia', 'Mastoid disorder', 'Tinnitus']",1,PFIZER\BIONTECH,IM 988684,TX,82.0,M,"Patient had fall x 2 with or without sycnope (conflicting documentation) with humeral fracture after recieving the vaccine. Workup demonstrated PE and DVT (appears PE was not submassive/massive, unlikely it directly precipitated fall/ syncope)",Not Reported,,Yes,Yes,4.0,Not Reported,Y,01/27/2021,01/27/2021,0.0,UNK,betaxolol (Betoptic S) 0.25 % ophthalmic suspension 1 Drop every day donepezil (Aricept) 10 mg tablet Take 10 mg by mouth at bedtime escitalopram oxalate (Lexapro) 10 mg tablet Take 10 mg by mouth every day for: major depressive disorder me,"Alzheimer's, depression, elevated intra-ocular pressure","Alzheimer's, depression, elevated intra-ocular pressure",,None,"['Angiogram pulmonary abnormal', 'Carotid arteriosclerosis', 'Computerised tomogram thorax', 'Deep vein thrombosis', 'Diastolic dysfunction', 'Echocardiogram abnormal', 'Ejection fraction', 'Ejection fraction decreased', 'Electrocardiogram normal', 'Fall', 'Haemarthrosis', 'Humerus fracture', 'Left atrial enlargement', 'Leukocytosis', 'Peripheral vein occlusion', 'Pulmonary embolism', 'Scan with contrast abnormal', 'Syncope', 'Tricuspid valve incompetence', 'Ultrasound Doppler', 'Ultrasound Doppler abnormal', 'White blood cell count increased']",UNK,PFIZER\BIONTECH, 988737,MN,33.0,F,"32 weeks pregnant, still pregnant. Side effect is dizziness two days after the first COVID vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/30/2021,2.0,OTH,"Prenatal vitamin, vitamin D, levothyroxine",None,32 weeks pregnant,,,"['Dizziness', 'Exposure during pregnancy', 'Pregnancy']",1,MODERNA,IM 988751,CA,80.0,M,worsening cough with pain,Not Reported,,Not Reported,Yes,1.0,Not Reported,,01/28/2021,01/29/2021,1.0,UNK,"Ofev, Protonix, Exelon, Lidoderm",,,,"Hydrocodone, clindamycin",['Cough'],UNK,MODERNA, 988763,,22.0,F,Urticarial and facial angioedema without respiratory symptoms treated the in ED with epi and discharged with recrudescence of her rash and angioedema several hours later and admitted for observation and symptomatic treatment,Not Reported,,Not Reported,Yes,1.0,Not Reported,,01/19/2021,01/28/2021,9.0,UNK,,,,,,"['Angioedema', 'Rash', 'Urticaria']",UNK,MODERNA, 991310,SC,,F,"Pfizer vaccine treatment under Emergency Use Authorization(EUA): Patient administered the Pfizer-biontech Covid 19 vaccine on 1/28/2021 at 15:19 in her LEFT deltoid. Patient reported feeling numbness and tingling to hands, face and leg within 15 minutes of the injection. No dyspnea, nausea, dizziness, abdominal pain, vision changes, or gait abnormality. VS 97.9F, 76, 16, 131/69, pulse ox 100%. ECG sinus rhythm.",Not Reported,,Not Reported,Yes,,Not Reported,,01/28/2021,01/28/2021,0.0,UNK,Medications patient takes at home: Dandelion Root 2 tab PO BID RF: 0 Pre Work Out Powder 1 pkt PO DAILY RF: 0 cyanocobalamin (vitamin B-12) [B-12 DOTS] 500 MCG tablet 500 mcg PO DAILY RF: 0 cinnamon bark 500 MG capsule 500 mg PO DAILY RF: 0,,,,"Reports allergy to: Acetaminophen, aspirin, and oxycodone","['Electrocardiogram normal', 'Hypoaesthesia', 'Paraesthesia']",UNK,PFIZER\BIONTECH,IM 991347,TX,86.0,M,"[Casirivimab/indevimab] treatment under Emergency Use Authorization(EUA): Infusion started at 9:45 and was stopped at 11:00. At 11:30 Patient developed SOB and drop in Sat from >96% to 88%. Patient had a large cough and expectorated a quarter size of brown phlegm. Code blue was activated, patient placed on NRB 180/81, 72, 24, 91%. Patient was AAOx3 and talking during this time. Patient transferred to the ER gurney and transported to ER for further evaluation. From H&P: tested positive for COVID-19 outside facility on 1/22 w/onset of covid sxs on 1/18 after returning from hunting trip with son on 1/17. Patient s/p Moderna vaccine #1 on 1/14/2021. Initially symptoms were just fatigue, cough, and chills and then spiked low grade fever on 1/20. Patient began to experience weakness and difficulty walking on 1/24 and fell from standing on 1/25 and possibly hit his head but without LOC. Patient presented to ED complaining of SOB that began after receiving monolconal antibodies about an hour PTA. Patient states that prior to the infusion, he was not feeling overly short of breath. After the transfusion, a code blue was called in the parking lot due to the patient becoming light-headed and short of breath - he never lost pulses. Upon arrival to the ED, he was in obvious respiratory distress and O2 sats were 92% on 15L NRB and patient switched to BIPAP. Patient given dose of epinephrine injection,after which he states he began feeling better.",Not Reported,,Not Reported,Yes,,Not Reported,,,,,UNK,Casirivimab/imdevimab; apixaban; captopril; fluticasone nasal spray; HCTZ/triamterene; omeprazole; simvastatin,,"COVID-19, osteoarthritis, hypertension, hyperlipidemia, BPH, GERD, atrial fibrillation",,,"['Asthenia', 'Bilevel positive airway pressure', 'Cardio-respiratory arrest', 'Chills', 'Cough', 'Dizziness', 'Dyspnoea', 'Fall', 'Fatigue', 'Gait disturbance', 'Infusion', 'Oxygen saturation decreased', 'Pyrexia', 'Respiratory distress', 'SARS-CoV-2 test positive', 'Sputum discoloured']",UNK,MODERNA, 991365,IN,,F,"[COVID-19 Vaccine, Pfizer] treatment under Emergency Use Authorization(EUA): Patient presented to outside hospital with petechial rash around injection site and within mouth. COVID Vaccine was administered 1/22. For 2 days following the vaccine she felt extreme fatigue and headaches. By Monday 01/25/2021 her symptoms had improved but then developed a diffuse rash and sores on her gums. Evaluation in the outside ED showed a platelet count of 2,000. Patient was transferred to our hospital for increased level of care, hematology consult, and platelet transfusion. Thrombocytopenia likely sec immune mediated destruction vs infection vs medications vs unlikely MDS or marrow infiltrative process.",Not Reported,,Not Reported,Yes,,Not Reported,,01/22/2021,01/26/2021,4.0,UNK,Albuterol inhalation; Trulicity injection; Lexapro; Amaryl; Hydrochlorothiazide; Basaglar Insulin injection; Lisinopril; Lorazepam; Metformin,,"Allergy/intolerance to ibuprofen noted hypertension, diabetes mellitus, and arthritis",,,"['Fatigue', 'Headache', 'Immune thrombocytopenia', 'Infection', 'Injection site rash', 'Injection site reaction', 'Noninfective gingivitis', 'Oral mucosal eruption', 'Petechiae', 'Platelet count decreased', 'Platelet transfusion', 'Rash macular', 'Thrombocytopenia']",UNK,PFIZER\BIONTECH, 991407,,46.0,F,"Patient is a healthcare worker who received COVID-19 vaccine through her employee health vaccination program. 2 days later, patient developed subconjunctival hemorrhages, then fever, headache, and blisters on trunk. Over the next several days the blisters developed into pruritic pustules including extremities, palms, and soles and patient had increasing joint pain and stiffness in extremities. Patient was seen by rheumatology who thought this may be flare of her psoriatic arthritis or a viral etiology. They deferred treatment with steroids since she was due to receive her 2nd dose of the COVID-19 vaccine soon. Patient received 2nd dose of COVID-19 vaccine and called employee health 2 days later with fever, headache, nausea, swollen lymph nodes, rash spreading to head, and congestion. COVID-19 swab neg. She was seen at an urgent care and diagnosed with pneumonia and was started on doxycycline. Three days later, she presented to the emergency department and was admitted with fever, cough, sob, continued rash (macular and pustular), reported worst headache of life and continued worst arthritis flare of life. Patient was seen multiple times by a variety of clinicians throughout her illness including dermatology, rheumatology, emergency medicine, and internal medicine. Patient had an extensive work-up to identify causes including negative blood cultures, RPR, varicella PCR, respiratory pathogen panel, gonorrhea/chlamydia PCR, HIV, and lumbar puncture with bacterial, viral, and fungal testing. The most common themes of provider assessments were that patient had a psoriatic arthritis flare (worst of life per patient report) which may have been related to the first dose of the COVID-19 vaccine. After 2nd dose of vaccine, patient was diagnosed with guttate psoriasis which was thought to be either related to COVID-19 vaccine or Humira as TNFi has been linked to guttate psoriasis, although Humira was not a new med, and this had not happened in the past.",Not Reported,,Not Reported,Yes,,Not Reported,,,,,UNK,"Humira, celecoxib, leflunobide, lisdexamfetamine, omeprazole, tizanidine, amlodipine, COVID-19 vaccine",,"Hypertension (HTN); Obesity; psoriatic arthritis, migraines, hyperparathyroidism",,,"['Arthralgia', 'Arthritis', 'Bacterial test', 'Blister', 'Blood culture negative', 'Chlamydia test', 'Condition aggravated', 'Conjunctival haemorrhage', 'Cough', 'Dyspnoea', 'Fungal test', 'Guttate psoriasis', 'HIV test', 'Headache', 'Lumbar puncture', 'Lymphadenopathy', 'Musculoskeletal stiffness', 'Nausea', 'Nucleic acid test', 'Pneumonia', 'Polymerase chain reaction', 'Pruritus', 'Psoriatic arthropathy', 'Pustule', 'Pyrexia', 'Rash', 'Rash macular', 'Rash pustular', 'Respiratory viral panel', 'SARS-CoV-2 test negative', 'Treponema test', 'Viral test']",2,UNKNOWN MANUFACTURER,IM 991434,,67.0,M,"The patient developed an acute right posterior frontal stroke with weakness, dysarthria and hemineglect at 1015pm on 1/26. He had received the Moderna vaccine second dose on 1/25. He received tPA and is now in the ICU for monitoring. Also found to have atrial fibrillation on EKG which seems to be a new finding.",Not Reported,,Not Reported,Not Reported,,Not Reported,,,,,UNK,none; none,,,,,"['Asthenia', 'Atrial fibrillation', 'Cerebrovascular accident', 'Dysarthria', 'Electrocardiogram abnormal', 'Intensive care', 'Unresponsive to stimuli']",UNK,MODERNA,IM 991450,,,F,The patient developed left sided neck and trapezoid tightness and pain after receiving the moderna covid vaccine in her left shoulder. The injection site is non tender and does not show any erythema or tenderness. The tenderness is over the left trapezius and left lateral neck area. It also feel tight like a muscle spasm.,Yes,,Not Reported,Not Reported,,Not Reported,,,,,UNK,"Lisinopril, furosemide, omeprazole, amlodipine, meclizine, loratadine",,"Coronary artery disease (CAD); Hypertension (HTN); Renal Disease (e.g. CKD, HD, ESRF)",,,"['Muscle spasms', 'Muscle tightness', 'Myalgia', 'Neck pain']",UNK,MODERNA,IM 991465,,72.0,M,Patient previously was diagnosed with COVID-19 and recovered in 12/20. Patient received MODERNA COVID-19 vaccine 72 hours PTA. Patient developed soreness and achiness and fevers 48 hours PTA. This was followed by progressive redness of the skin on left upper arm at vaccine injection site. Patient was then admitted with left upper arm cellulitis with sepsis criteria.,Not Reported,,Not Reported,Yes,,Not Reported,,,,,UNK,"simvastatin, meloxicam, losartan, fluticasone propionate, bisoprolol-hydrochlorothiazide, albuterol",,"Asthma/COPD; Hypertension; COVID-19, arthritis, hyperlipidemia, neuropathy",,,"['Injection site cellulitis', 'Injection site erythema', 'Pain', 'Pyrexia', 'Sepsis']",UNK,MODERNA,IM 995143,,83.0,M,"falling, weakness Narrative:",Not Reported,,Not Reported,Yes,,Not Reported,U,01/23/2021,01/24/2021,1.0,OTH,,,,,,"['Asthenia', 'Fall']",1,PFIZER\BIONTECH,IM 995144,,77.0,M,possible M/I chest pain Narrative: On 1/29/20 patient taken to local hospital via ems then was transferred to second hospital to rule M/I,Not Reported,,Not Reported,Yes,,Not Reported,U,01/27/2021,01/29/2021,2.0,OTH,,,,,,['Chest pain'],UNK,MODERNA,IM 995148,,71.0,M,"PERICARDIAL EFFUSION Narrative: Patient with history of pleural effusions and recurrent pericardial effusions presented 9/11/20 to facility ~7 days following influenza vaccination for routine imaging and found to have abnormal chest CT with concern for pericardial effusion. Patient not admitted at the time, however presented to ED 9/25/20 with worsening shortness of breath and cough. Patient admitted for bacterial pneumonia with parapneumonic effusion. Discharged 10/10/20. At 10/16/20 PCP visit, patient reported he believed the event was triggered by influenza vaccine.",Not Reported,,Yes,Yes,,Not Reported,U,,09/17/2020,,OTH,,,,,,"['Computerised tomogram thorax abnormal', 'Cough', 'Dyspnoea', 'Infectious pleural effusion', 'Pericardial effusion', 'Pneumonia bacterial']",UNK,UNKNOWN MANUFACTURER, 988876,WI,40.0,F,"sore left arm x 2 days, muscle fatigue, chills",Not Reported,,Not Reported,Not Reported,,Yes,Y,01/20/2021,01/29/2021,9.0,PVT,Fluoxetine - 60mg daily Lorazepam - 1-2.5mg daily Orphenadrine - 100mg ER BID Zofran ODT 4mg PRN Zolpidem 10mg 1-1.5 tabs per evening,,POTS Vestibular/Hemiplegic Migraines,,Pertussis vaccine _ anaphylaxis,"['Chills', 'Muscle fatigue', 'Pain in extremity']",1,MODERNA,IM 988971,TN,88.0,F,"On the 28th, she began complaining of sore right shoulder. By 30th, moving her arm was extremely painful. That morning, her temp was 95, By 8pm, her temp was 101. We took her to the ER. The ER drained fluid off her shoulder and found extremely high white blood cell count and sepsis had set in. They hospitalized her last night (Jan 30). She is on high dose of antiobiotics. She hasn't been ill and this week, only trip from home was for a curbside pickup.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/18/2021,01/28/2021,10.0,PVT,Blood pressure & colestoral meds only.,None,Intermittent foot neuropathy,,erythrmycin & statins,"['Arthralgia', 'Arthritis bacterial', 'Aspiration joint', 'Body temperature increased', 'Joint fluid drainage', 'Pain', 'White blood cell count increased']",1,PFIZER\BIONTECH, 988994,CT,66.0,M,Resident coded on 1/12/2021,Not Reported,,Not Reported,Yes,16.0,Not Reported,N,01/05/2021,01/12/2021,7.0,SEN,,,"COPD, Type II Diabetes Mellitus, Hypertension, PVD, Absence of left leg above the knee, CKD, history of Acute Respiratory failure with hypoxia",,No Known Drug Allergies,['Cardio-respiratory arrest'],1,PFIZER\BIONTECH,IM 989006,VA,58.0,F,"After being observed for approximately 20 minutes and patient walked to her car without assistance I was called to assess the patient in the parking lot for troubles breathing. EMS was called as I made my way outside. Upon my arrival patient was leaning out of the car and stating that she could not breath. She was able to tell me that she was allergic to penicillin. Oxygen was immediately placed on the patient with minimal relief. Lung sounds were coarse throughout. She then began to vomit about every 20-30 seconds. Epipen was administered in the right leg with no relief. Patient continued to complain of troubles breathing and vomiting. A second epipen was administered in the patients right arm again with no relief. A few minutes later patient was given racemic epinephrine through the oxygen mask. There appeared to be mild improvement in her breathing as she appeared more comfortable, but still complaining of shortness of breath and vomiting. When EMS arrived patient was unable to transport herself to the stretcher. When EMS and clinical staff transferred patient to the stretcher she became unresponsive. She appeared to still be breathing. She did not respond to verbal stimuli. Per ED report large amount of fluid was suctioned from the patients lungs following intubation in the ambulance. When patient arrived to the ED she was extubated and re-intubated without difficulty and further fluid was suctioned. At that time patient was found to be in PEA, shock was delivered. Shortly thereafter no cardiac activity was found and patient pronounced dead.",Yes,01/30/2021,Yes,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,PVT,"Per reviewed on medical records: metformin, gabapentin, glipizide",unknown,diabetes obesity hypoventilation syndrome,,penicillin latex,"['Airway secretion clearance therapy', 'Breath sounds abnormal', 'Cardiac arrest', 'Cardioversion', 'Death', 'Dyspnoea', 'Endotracheal intubation', 'Mobility decreased', 'Pulseless electrical activity', 'Unresponsive to stimuli', 'Vomiting']",1,PFIZER\BIONTECH,IM 989015,CT,69.0,M,Myocardial Infarction,Yes,01/27/2021,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,SEN,,,"End Stage Renal Disease, NON ST Elevation (NSTEM) Myocardial Infarction,, Type II Diabetes Mellitus, Cardiac Arrest cause unspecified, Paroxysmal atrial fibrillation, acute embolism and thrombosis of unspecified deep veins of right lower extremity, Alzheimer's disease, Chronis systolic heart failure,",,No known allergies,['Myocardial infarction'],2,PFIZER\BIONTECH,IM 989059,RI,31.0,F,The next day of vaccination on 1/10/2021 I started feeling fatigue & astragalus. It lasted for about 6hrs.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,PVT,Zertalin zomonari 20mg,No,No,2013 after the flue vaccine I had malaise,No,['Fatigue'],2,PFIZER\BIONTECH,SYR 989088,OH,,U,"approx 2-3 days post vaccine, started having diarrhea and rhinorrhea. The developed some abd pain (different than his usual pain). Followed by frequent vomiting leading to his emergency department visit today.",Not Reported,,Not Reported,Yes,,Not Reported,N,,,,PVT,,,,,,"['Abdominal pain', 'Chest X-ray', 'Computerised tomogram abdomen', 'Computerised tomogram pelvis', 'Diarrhoea', 'Laboratory test', 'Rhinorrhoea', 'Urine analysis', 'Vomiting']",UNK,MODERNA, 989124,OK,75.0,F,She had orthostatic hypotension and dizziness 2-3 hours post vaccination with blood pressure on standing of 70 systolic. She was observed in the hospital overnight,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/30/2021,01/30/2021,0.0,PVT,There are numerous she is a heart transplant patient,None,"heart transplant, diabetes, hypertension, hyperlipidemia",,diphenhydramine and mereperidine,"['Dizziness', 'Laboratory test normal', 'Orthostatic hypotension']",1,MODERNA,IM 989143,IL,85.0,M,"Chills, Fever, Weakness",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/27/2021,01/27/2021,0.0,SEN,,,,,,"['Asthenia', 'Chills', 'Pyrexia']",UNK,PFIZER\BIONTECH, 989164,CA,35.0,F,"hemiplegic migraine, blurry vision, slurred speech, high bp 140/103, l",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/14/2021,01/27/2021,13.0,WRK,,,"migraines, rbbb",,,"['Angiogram normal', 'Blood test normal', 'Computerised tomogram head normal', 'Computerised tomogram neck', 'Dysarthria', 'Echocardiogram normal', 'Electrocardiogram ambulatory normal', 'Electroencephalogram normal', 'Hemiplegic migraine', 'Hypertension', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging neck', 'Scan with contrast', 'Vision blurred']",2,PFIZER\BIONTECH,IM 989170,NC,60.0,F,Left arm tingling and numbness - continues today. Left eye droopiness - x 1.5 weeks. Resolved.,Not Reported,,Not Reported,Not Reported,,Yes,N,01/04/2021,01/07/2021,3.0,PUB,sertraline 50 mg by mouth once daily NP thyroid replacement vitamin C 5000 mg vitamin D 5000 mg,none,hypothyroidism due to total thyroidectomy (cancer) 9/2010,,,"['Eye disorder', 'Facial paralysis', 'Hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 989210,TX,48.0,M,"About 5 days after I received my injection, my blood pressure went to 170/ 100 for about 2 -3 hours. I was kept one night at the hospital due to an image of my lungs. My blood pressure had been good and it still has not come down. I am not sure if this is due to injection or not.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/07/2021,01/11/2021,4.0,PUB,"Metformin, olmesartan medoxomil, aspirin, centrum vitamin, fish oil, calcium, vitamin c",,"diabetes, elevated blood pressure",,none,"['Blood pressure increased', 'Imaging procedure abnormal']",1,MODERNA,SYR 989244,NJ,51.0,F,"Throat closing, palpitation, lightheadedness, cough with bronchospasm",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,09/09/1969,01/12/2021,18753.0,WRK,Synthroid 88mcg,none,none,,Shell-fish,"['Bronchospasm', 'Cough', 'Dizziness', 'Intensive care', 'Palpitations', 'Throat tightness']",2,PFIZER\BIONTECH,IM 989277,IL,84.0,F,Vomiting,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/27/2021,01/27/2021,0.0,SEN,,,,,PENICILLIN,['Vomiting'],UNK,MODERNA, 989320,NY,41.0,F,The next day of vaccine on 1/10/2021 in the afternoon I started feeling very fatigue & taquicardia my heart rate was in the 90s. On 1/11/2021 I couldn't do anything I stayed home I still had fatigue but I also had a server headache. The fatigue went away by 1/12/2021 but I still had a headache it felt like a pressure headache & that went away until 1/16/2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/10/2021,1.0,WRK,No,Tested positive for Covid on 12/26/2020,No,,No,"['Exposure during pregnancy', 'Fatigue', 'Head discomfort', 'Headache', 'Tachycardia']",1,MODERNA,SYR 989333,CA,69.0,M,"Out of know where on 1-13-21 awoke at 3:00 AM with severe anxiety which has continued to date, 1-31-21 but not as severe. Unable to sleep, no matter what medication given. At beginning had high blood pressure which is unusual for me and heart palpitations. Had two trips to the ER , 1-13-21 9:00 PM, released and 1-15-21 10:00 PM and admitted, kept for one day. Heart palpitations decreased within the first week and blood pressure came down to normal. Unable to sleep, after being given Hydroxyzine Hydrochloride-25mg and later Alprazolam-.5 mg. Tried taking herbs before taking Alprazolam due to the addiction factor. Took Kava , Deep Sleep and CBD. Took Alprazolam after herbs didn't seem to help but it made me feel bad and didn't help with the sleep so went to over the counter sleep aid.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/31/2020,01/13/2021,13.0,PUB,"Rosuvastatin-20mg, Fish oil-1000mg, Aspirin-low dose, Cinnamon-1000mg.",,High Cholesterol,,Lipitor,"['Anxiety', 'Blood test normal', 'Cardiac stress test normal', 'Echocardiogram normal', 'Electrocardiogram normal', 'Hypertension', 'Insomnia', 'Palpitations']",1,MODERNA,SYR 989360,NE,31.0,M,"Gross hematuria with clots. AKI with elevated creatinine to 2.18 (Baseline <1.0). UA with moderate blood, positive nitrite, moderate LE, >50 rbcs Urine lytes WNL, Pr:Cr 3.3, Al:Cr 1,245 C3/C4 WNL US with mildly echogenic kidneys, a nonspecific indicator of medical renal disease. �No hydronephrosis. Thick-walled nondistended urinary bladder. Hgb decreased to 12.9 from 15 Pt underwent a kidney biopsy, pathology is still pending. He received aggressive IVFs and was monitored for 2 days. He was discharged following the kidney biopsy. At that time he was still having hematuria although it was improving and his hemoglobin was stable.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/26/2021,01/27/2021,1.0,UNK,Acetaminophen,None,Hx of shingles,,Penicillins-Rash,"['Acute kidney injury', 'Biopsy kidney', 'Bladder hypertrophy', 'Blood creatinine increased', 'Complement factor C3', 'Complement factor C4', 'Haematuria', 'Haemoglobin decreased', 'Haemorrhage urinary tract', 'Nephropathy', 'Nitrite urine present', 'Urine analysis abnormal', 'Urine electrolytes normal', 'Urine leukocyte esterase positive']",2,MODERNA,IM 989439,FL,83.0,F,"Initially itching, painful burning hives and welts on both arms began about Jan 12-13. Began low dose benedryl from 1/13 - 1/25. Second adverse event on Jan 25; began sudden onset of dizziness, weakness, nausea, vomiting and unusual blood pressure elevation. Went to ER @4 pm.. Released after 6 hours. Same occurrence next day, similar symptoms. Began to feel 'bad'; BP still elevated. Went to closest ER at 3 pm. Discharged after 5 hours with clonidine. Skipped a day, but could not resume normal activities. On Jan 29 returned to ER early afternoon, admitted for observation. Discharged ~6:30 pm on Jan 30. Currently only on higher dose of losinipryl. Rash bumps persist as 'red streaks', elevated BP and not feeling well. Streak is inner right arm above elbow. Rash streaks continue but are not bother some. Including morning of 1:30 after night in hospital. Rash usually appears after sleeping and early a.m. No medication. Still unable to resume normal activities. ""feel terrible"".",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/05/2021,01/12/2021,7.0,PVT,"Lisenopril Vitamin C, Vitamin E, Magnesium, CoQ10","right breast lumpectomy Dec 10, 2020 and medications given with this. No radiation, no chemo., no hormone drugs","hypertension,",,"sulfa, anfid, contrast iodine injected","['Angiogram', 'Asthenia', 'Blood pressure increased', 'Blood test', 'Burning sensation', 'Cardiac monitoring', 'Computerised tomogram head', 'Dizziness', 'Feeling abnormal', 'Gastrointestinal scan', 'Injection site reaction', 'Injection site streaking', 'Loss of personal independence in daily activities', 'Malaise', 'Nausea', 'Pain', 'Pruritus', 'Rash erythematous', 'Ultrasound scan', 'Urticaria', 'Vomiting']",1,MODERNA,IM 989505,CA,49.0,M,"acute fever, chills, body aches, nausea, headache starting 2 hours after injection and lasting 4 days. on day 5 onset of right posterior shoulder pain, with worsening numbness and weakness of the right arm and hand, specifically to wrist extension, grip strength and finger adduction.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/26/2021,01/26/2021,0.0,PVT,"Metformin, amlodipine, aspirin, atorvastatin, omeprazole, candesartan",none reported,"diabetes, htn","patient had fever, body aches, chills for 2 days following 1st dose of moderna covid vaccination","allegra, latex","['Arthralgia', 'Asthenia', 'Chills', 'Grip strength decreased', 'Headache', 'Hypoaesthesia', 'Injection site hypoaesthesia', 'Injection site muscle weakness', 'Muscular weakness', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,IM 989508,CO,75.0,F,"All information per patient's husband: patient started experiencing severe headache on the day of vaccination. Headache continued for three days during which no medical attention was sought. Confirmed that patient never took any NSAIDs to treat headache during this time. On day 4, patient had a subdural hematoma accompanied by two seizures upon which she was flown to a hospital to receive treatment. Husband did state that patient is on warfarin due to factor V deficiency and that treating physician thought that this was most likely caused by the warfarin, however that the vaccine could not be ruled out completely. Husband also said INR has always been within normal limits.",Not Reported,,Yes,Yes,4.0,Not Reported,U,01/03/2021,01/03/2021,0.0,PHM,"Warfarin, blood pressure medications (husband not sure of names), statin, over the counter fish oil, colchicine PRN, acetaminophen PRN-- might not be a complete list of medications as we do not fill for her and husband was unsure of her med",,"Gout, Factor V deficiency, hypertension",,Sulfa,"['Headache', 'Seizure', 'Subdural haematoma']",UNK,MODERNA,IM 989541,NJ,75.0,M,"Other than sore arm after vaccine, developed weakness and melena 2 days later on Friday the 22nd and intermittent for next 3 days. He saw cardiologist the following Friday (29th) who advised blood work. The next day sent to ER as hgb was only 5.2. EGD. He received 3 units of PRBC and a gastric AVM was cauterized. He has had a Type 2 MI and is still hospitalized.",Not Reported,,Yes,Yes,,Not Reported,N,01/20/2021,01/22/2021,2.0,SCH,Baby aspirin every other day,NO other acute illnesses,"DM2, CKD, CAD, spinal stenosis",,NKA,"['Acute myocardial infarction', 'Asthenia', 'Blood creatinine increased', 'Blood urea increased', 'Haemoglobin decreased', 'Melaena', 'Oesophagogastroduodenoscopy abnormal', 'Packed red blood cell transfusion', 'Pain in extremity', 'Troponin increased', 'Vascular cauterisation']",UNK,MODERNA,IM 989556,AZ,59.0,F,"1st dose at 12/23/20 -> myalgia and loss of appetite, both persisting until 01/19/21. 2nd dose at 01/21/21 -> fever, chill, nausea, vomiting, loss of appetite, generalized weakness, fatigue Admitted to hospital on 01/31/21. Initial exam show normal neurologic signs. Several hours after initial exam, patient developed 0 to 1/5 strength in all 4 extremities with absent ankle reflexes bilaterally.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,MIL,"Clobetasol propionate, diclofenac gel, carvedilol, HCTZ/Triamterene, K chloride, hydroxyzine, estradiol, prednisone",None,"Pituitary tumor (hyperprolactinemia), HTN, HLD, vertigo, SVT, hypokalemia",,Morphine,"['Areflexia', 'Asthenia', 'Blood albumin decreased', 'Blood calcium decreased', 'Blood glucose increased', 'Blood phosphorus decreased', 'Blood potassium decreased', 'Chills', 'Decreased appetite', 'Fatigue', 'Full blood count normal', 'Hyperglycaemia', 'Hypoalbuminaemia', 'Hypocalcaemia', 'Hypokalaemia', 'Hypophosphataemia', 'Metabolic function test abnormal', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",2,MODERNA,IM 989565,LA,78.0,F,"Patient reported that after a couple of hours of receiving the covid vaccine, she became dizzy, nauseated, and lightheaded. She reported her blood pressure was low 80/60 and her heart rate about 100. She rested and her pressure came up. Then she reported a couple hours later she felt that way again while walking around house. She sat down and felt better. Then around 6p symptoms came back and she also had a headache and a little shortness of breath. She then decided to go to the ER.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/27/2021,01/27/2021,0.0,PVT,"Plavix 75mg po daily, ASA DR 81mg po daily, Lutein 20mg po daily, Lovaza 1 gm oral twice daily, Metoprolol tartrate 25mg po at bedtime, Simvastatin 20mg po daily, Co Q 10 po daily, Vitamin D3 4000 units po daily, Nitroglycerin Translingual",Unknown,"GERD, Hypertension, TIA, Stented coronary artery",,"Cortisone, Dilaudid, Morphine, Myacins, Penicillin, Fructose","['Activated partial thromboplastin time', 'Brain natriuretic peptide', 'Chest X-ray', 'Computerised tomogram head', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Full blood count', 'Headache', 'Hypotension', 'International normalised ratio', 'Metabolic function test', 'Nausea', 'Prothrombin time', 'Troponin', 'Urine analysis']",1,PFIZER\BIONTECH,IM 989665,TX,49.0,F,about 6 hours post vaccine I started having chills and a headache. 11 hours post vaccine my hands became paralyzed in severe contracture. My face and feet and legs were number. I could barely breathe. I had to be transferred by Ambulance to Hospital,Not Reported,,Yes,Not Reported,,Not Reported,Y,01/30/2021,01/30/2021,0.0,PVT,one a day vitamin tramadol dicyclomine omeprazole Valium Atorvastatin,Arthritis Irritable bowel syndrome Anxiety High cholesterol,Arthritis Irritable bowel syndrome Anxiety High cholesterol,,Allergy to lime jello - hives,"['Chills', 'Dyspnoea', 'Electrocardiogram', 'Headache', 'Hypoaesthesia', 'Joint contracture', 'Laboratory test', 'Paralysis']",UNK,MODERNA,IM 989695,CA,84.0,M,"Few hours after receiving treatment his arm became very sore which is normal, but the next day he had a severe reaction in his back resulting in an unbearable pain. Each day the pain has gotten worse and now a week later he is in the worst shape so far. The primary care Physician has associated the symptoms with the vaccine and on the 25th he saw a cardiologist who again blamed it on the vaccine",Not Reported,,Not Reported,Not Reported,,Yes,N,01/23/2021,01/24/2021,1.0,OTH,"Vitamin C, D, Calcium, Fish oil, , multivitamin , stool softener(OTC) Alendronate 70 mg (1x/week); atorvastatin 40 mg, carvedilol 3.1 mg, Eliquis 5mg, levothyroxine 75mcg, memantine 5mg,",,"Back pain due to a fall last February 2000, kyphoplasty surgery last October 2020, and Prostate TURP also in Oc. 2020",,None,"['Back pain', 'Cardiovascular evaluation', 'Condition aggravated', 'Pain in extremity', 'Vaccination complication']",1,MODERNA,IM 989704,ME,98.0,F,"3 days ago patient was started on Cipro for a UTI. Patient received the ModernaCOVID vaccine 2 days ago. The past 48 hours patient has had increased confusion, decreased p.o. intake. Patient was sent to emergency room for evaluation. Patient was found to have a low sodium, 112, high potassium 6.9 with corresponding EKG changes. Patient was bradycardic with a rate between 30 and 40. Patient was also found to be in acute renal failure with a creatinine of 5.6. In ER pt was confused, unable to tolerate PO fluids. Due to severity of illness patient's family has elected to avoid aggressive medical care. Patient has poor prognosis. Patient was returned to nursing home for comfort care only.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/29/2021,01/31/2021,2.0,SEN,"Ferrous Sulfate Oral, daily. Hydrocortisone External. Levothyroxine Sodium Oral (Tablet 75 mcg), daily. Metoprolol Tartrate Oral (Tablet 50 mg), 2x a day. Nystatin External. Trimethoprim Oral (Tablet 100 mg), daily at bedtime. Tyl",Recent UTI,Hypokalemia. Hypertension. Hypomagnesemia. Lumbar Radiculopathy. Dysuria. Hypothyroidism. DVT - Deep Venous Thrombosis. Hemorrhoids. Renal Failure. Heart Disease. Sciatica. Sepsis (disorder). UTI - Urinary Tract Infection. Urinary Retention. Myofascial Strain. Lumbar Strain. Nephropathy. Rectal Bleed. Pneumonia.,,Baclofen. Fentanyl. Sulfa Antibiotics. --,"['Acute kidney injury', 'Albumin globulin ratio', 'Anion gap normal', 'Aspartate aminotransferase normal', 'Base excess increased', 'Basophil count decreased', 'Basophil percentage decreased', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bicarbonate decreased', 'Blood bilirubin decreased', 'Blood calcium decreased', 'Blood chloride decreased', 'Blood creatine increased', 'Blood creatinine decreased', 'Blood creatinine increased', 'Blood glucose normal', 'Blood lactic acid normal', 'Blood magnesium normal', 'Blood pH decreased', 'Blood potassium increased', 'Blood sodium decreased', 'Blood urea increased', 'Bradycardia', 'C-reactive protein increased', 'Carbon dioxide decreased', 'Chest X-ray', 'Chronic obstructive pulmonary disease', 'Confusional state', 'Electrocardiogram abnormal', 'Eosinophil count decreased', 'Eosinophil percentage decreased', 'Full blood count', 'Globulin', 'Glomerular filtration rate decreased', 'Granulocyte count decreased', 'Haematocrit decreased', 'Haemoglobin decreased', 'Haemolysis', 'Hypophagia', 'Immature granulocyte count increased', 'Lymphocyte count decreased', 'Lymphocyte percentage decreased', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Mean platelet volume normal', 'Monocyte count decreased', 'Monocyte count normal', 'Monocyte percentage', 'Neutrophil count increased', 'Neutrophil percentage increased', 'Platelet count increased', 'Protein total normal', 'Red blood cell count decreased', 'Red blood cell nucleated morphology', 'Red cell distribution width increased', 'Venous oxygen partial pressure', 'Venous oxygen saturation decreased', 'Venous oxygen saturation normal', 'White blood cell count increased']",2,MODERNA, 989739,CA,69.0,F,"Cellulitis- infection. Initial treatment was antibiotics orally administered. Second day as symptoms worsened, injection of ceftriaxone.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/22/2021,01/30/2021,8.0,OTH,"Atrovastatin, synthoid.",,,,None,['Cellulitis'],1,MODERNA, 989756,,42.0,F,"12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area Jan. 2 & 3: didn?t sleep well Jan. 4: mental fatigued Jan. 7: fever 101.2F, shallow breathing, upper quadrant pain, rash on neck Jan. 8: rash on abdomen; right flank pain?spoke with her Endocrinologist who think reactions are auto-immune related Jan. 15: increased blood pressure?consulted a Cardiologist and was prescribed a medication Jan. 15: had labs drawn?IgG 69 Jan. 28: consulted with a Neurologist who think she may have acute encephalitis related to the vaccine and recommended not to get the 2nd dose",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/26/2020,01/02/2021,7.0,UNK,,,,,,"['Abdominal pain upper', 'Autoimmune disorder', 'Blood immunoglobulin G decreased', 'Blood pressure increased', 'Flank pain', 'Hypopnoea', 'Mental fatigue', 'Poor quality sleep', 'Pyrexia', 'Rash', 'Swelling']",1,PFIZER\BIONTECH,IM 989768,CT,82.0,M,"Exertional dyspnea, hypoxia, wheezing, low-grade fever, muscle pain",Not Reported,,Not Reported,Yes,,Not Reported,N,01/29/2021,01/30/2021,1.0,PVT,"Fever,Myalgias, is there snow dyspnea, wheezing, hypoxia",None,"Hypertension, hyperlipidemia",,Sulfa drugs,"['Dyspnoea exertional', 'Hypoxia', 'Myalgia', 'Pyrexia', 'Wheezing']",UNK,MODERNA,IM 989821,LA,70.0,F,Went into a sustained A fib event at approximately 8:30 pm approximately 11 hours after receiving vaccine. Entered ER and was treated for A fib with A fib lasting approximately 10 hours with cardiziem administration and continued to be hospitalized for another 6 hours for monitoring for stability.,Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/29/2021,01/29/2021,0.0,OTH,"Felicainide, metoprolol, eliquis, np thyroid, per pro, rosuvastatin, venlafaxine, busppirone, zinc, vit D3, turmeric, b complex, elderberry, vit c, biotin, daily multiple vitamin",None,"Hypothyroidism, medication controlled A fib",,None,"['Atrial fibrillation', 'Chest X-ray', 'Condition aggravated', 'Electrocardiogram', 'Laboratory test']",1,PFIZER\BIONTECH,IM 989822,TX,52.0,M,"The patient had a very severe side effect profile from the second dose of vaccine: ""worst I've ever felt"" with myalgia, headache, fever and fatigue. This subsided and then on day 3 he developed severe substernal chest pain and came to ER where his hs-cTnI was > 2000 ng/L and peaked at 6700 ng/L. His ECG, echo and cardiac cath were normal but MRI showed evidence of myocarditis with mild left ventricular dysfunction. He is doing well clinically and we are managing expectantly. This appears to be immune mediated myocarditis from the Moderna vaccine",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,01/26/2021,01/29/2021,3.0,PVT,"Lisinopril, atorvastatin, ezetimibe,",None,none,,No,"['C-reactive protein increased', 'Catheterisation cardiac normal', 'Chest pain', 'Echocardiogram normal', 'Electrocardiogram normal', 'Fatigue', 'Headache', 'Left ventricular dysfunction', 'Magnetic resonance imaging abnormal', 'Magnetic resonance imaging heart', 'Malaise', 'Myalgia', 'Myocarditis', 'Pyrexia', 'Red blood cell sedimentation rate increased', 'SARS-CoV-2 test negative', 'Troponin T increased', 'Troponin increased']",UNK,MODERNA,IM 989918,CT,89.0,F,Stroke,Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/26/2021,01/27/2021,1.0,PVT,Stroke,None,"Paroxysmal a fib, hypothyroidism, hypertension, rheumatoid arthritis",,Codeine; Walnuts,['Cerebrovascular accident'],2,PFIZER\BIONTECH,IM 989988,MI,52.0,M,Diagnosed day after 2nd shot with opthalmic artery thrombus causing vision loss/change in left eye. I did get shot series on 12/22/2020 #1 and 1/10/2021 and was diagnosed with Covid-19 on 12/13/2020. My internist MD did not feel the vaccine caused the thrombus /Stroke but I wanted to report it as it was associated with the vaccine administration (symptoms of vision loss within 24 hours of the vaccine #2 administration).,Not Reported,,Not Reported,Not Reported,,Yes,N,01/10/2021,01/11/2021,1.0,PVT,doxepin in evening for sleep 5mg asprin 325mg daily,Covid 19 infection diagnosed 12/23/2020,angioedema periodic due to sulfite allergy,,sulfites- angioedema,"['Blindness unilateral', 'COVID-19', 'Cerebrovascular accident', 'Ophthalmic artery thrombosis', 'Retinal artery occlusion', 'Retinal artery thrombosis', 'Retinal infarction', 'Retinogram abnormal', 'Visual impairment']",2,PFIZER\BIONTECH,IM 990034,TX,79.0,M,I helped facilitate scheduling for his COVID vaccine and received notification from his wife that he passed away unexpectedly this morning. She reported he had been experiencing a rheumatoid arthritis flare and was on steroids. His diabetes was not well controlled as a result. He did not have any reactions in the days immediately after the vaccine.,Yes,01/31/2021,Not Reported,Not Reported,,Not Reported,N,01/17/2021,01/31/2021,14.0,UNK,,,"Rheumatoid arthritis, diabetes",,,"['Condition aggravated', 'Death', 'Rheumatoid arthritis']",UNK,MODERNA, 990043,,24.0,M,"24y/o male with remote history of Kawasaki disease fevers, chills, night sweats, anorexia, nausea, vomiting, dehydration, chest pain, dyspnea, constipation. Symptoms began around 1600 on 27JAN21 (day of immunization). Worsened on 28JAN21. On 29JAN21 presented to primary care with tachycardia prompting IV fluid resuscitation.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/27/2021,01/27/2021,0.0,MIL,None,None,None,,NOne,"['Blood calcium decreased', 'Blood lactic acid', 'Blood thyroid stimulating hormone decreased', 'C-reactive protein increased', 'Chest X-ray normal', 'Chest pain', 'Chills', 'Constipation', 'Decreased appetite', 'Dehydration', 'Dyspnoea', 'Echocardiogram', 'Electrocardiogram ST segment elevation', 'Electrocardiogram abnormal', 'Haematocrit normal', 'Haemoglobin normal', 'Nausea', 'Neutrophil percentage increased', 'Night sweats', 'Platelet count normal', 'Prohormone brain natriuretic peptide increased', 'Pyrexia', 'Red blood cell sedimentation rate increased', 'SARS-CoV-2 test negative', 'Sinus tachycardia', 'Tachycardia', 'Thyroxine', 'Troponin I increased', 'Vomiting', 'White blood cell count increased']",2,MODERNA,IM 990084,CA,56.0,M,Painful Left Axillary& left Supraclavicular Lymphadenopathies,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2020,01/31/2020,2.0,PVT,None,None,None,,None,"['Axillary pain', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 990086,MA,27.0,F,"Fatigue, headache, nausea, bodyaches, no appetite - Tylenol, sleep and fluids for symptoms - lasted 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/23/2021,1.0,PVT,No,No,No,,No,"['Decreased appetite', 'Fatigue', 'Headache', 'Nausea', 'Pain']",1,MODERNA,IM 990087,CA,45.0,F,Received vaccine on 1/15 and developed rash c/w shingles (herpes Zoster) on 1/28.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/28/2021,13.0,WRK,none,none,none,,none,"['Herpes zoster', 'Rash']",2,PFIZER\BIONTECH,IM 990088,WA,44.0,F,"Day 2, I couldn?t lift my left arm. It was extremely tender and painful. Day 3, I broke out in hives (torso, groin and armpits). Still unable to use my arm. Day 4, regained mobility of arm, the injection site was hot, red and tender. One week later, day 7, the red and swollen area had spread up and down my arm, shoulder to elbow. Day 8, it became very itchy. By day 10, visible signs had faded but it remained itchy. It is now day 15, and I have occasional itching sensation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,01/17/2021,1.0,PVT,"BuPROPion HCI ER (XL). Vit C, vit D","Unknown. I was feeling like I had a cold the week prior, had a COVID test on Jan 11, it was negative.",,,Penicillin,"['Feeling hot', 'Injected limb mobility decreased', 'Injection site erythema', 'Injection site pain', 'Pain in extremity', 'Pruritus', 'Tenderness', 'Urticaria']",1,MODERNA,IM 990089,AZ,40.0,M,"Oscillopsia, dizziness 10 hours later. Gradually subsided over 8 days, but still persists as if this report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/23/2021,1.0,SCH,Lisinopril 10mg/daily,,None,,,"['Dizziness', 'Oscillopsia', 'Visual acuity tests normal']",1,MODERNA,SYR 990090,AZ,38.0,F,Small red bumps spread out on chest and bottom of my back. A few on my arm and neck.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/22/2021,01/25/2021,3.0,UNK,Benadryl,None,None,,None,"['Rash', 'Rash erythematous']",1,PFIZER\BIONTECH, 990093,CA,77.0,F,Swelling of Left upper from top of arm to 1/2 way to elbow. On 1/31/21 the swelling decreases but redness started from mid upper arm to elbow with itching..,Not Reported,,Not Reported,Not Reported,,Not Reported,N,,01/26/2021,,PVT,,NONE,"ASTHMA,,COPD, Sleep apnea, Chronic Kidney disease, Barretts disease.",,"Sulfa Drugs, Lasinapril.Augmentin. Neosporin Ointment, Surgical tape.","['Erythema', 'Peripheral swelling', 'Pruritus']",1,MODERNA,IM 990094,IL,60.0,F,"6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days later 12 hrs after vaccination: Nausea, vomiting, headache, body aches, fever (100.7 at peak), chills. Lasted approximately 36 hours. 48 hours after vaccination: vaccinated arm has tingling sensation and weakness when raised, armpit lymph nodes tendor/sore - still have this symptom 3 days later. Took Aleve to alleviate symptoms. It lessened them somewhat but I was still not able to function fully for several days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,WRK,Tylenol,none,none,,Sulfa drugs penicillin,"['Chills', 'Headache', 'Injection site pain', 'Injection site swelling', 'Lymphadenitis', 'Muscular weakness', 'Nausea', 'Pain', 'Paraesthesia', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,SYR 990095,IL,30.0,F,"Moderna COVID-19 Vaccine EUA 1/21- arm dark red in color at injection site 1/21-1/23 nausea, diarrhea, headache, redness worsens, arm painful/hot/swollen 1/24-1/26 symptoms seem to have improved 1/26 night- nausea returns, loss of appetite 1/27 am- rash on arm which looks like wheels or bullseyes starting at injection site and spreading down to mid-forearm, benadryl taken, improved, returned again later, benadryl taken again with improvement... feels feverish, very pale, flushed cheeks, body aches, no temp 1/27-1/29- loss of appetite, intermittent chills/body aches, arm redness waxes and wanes, still warm to touch 1/30 night- 101 oral temp, night sweats 1/31- low grade temp in afternoon, arm improved in color, still warm to touch, virtual health visit with MD and in person immediate care visit",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/21/2021,8.0,PVT,None,None,"Migraines, IBS","Flu shot, 29, redness/warmth/swelling at injection site, 09/2020","amoxicillin, lactose intolerant","['Cellulitis', 'Chills', 'Decreased appetite', 'Diarrhoea', 'Flushing', 'Full blood count', 'Headache', 'Injection site erythema', 'Injection site rash', 'Metabolic function test', 'Nausea', 'Night sweats', 'Pain', 'Pain in extremity', 'Pallor', 'Peripheral swelling', 'Pyrexia', 'Rash', 'SARS-CoV-2 test', 'SARS-CoV-2 test negative', 'Skin warm']",1,MODERNA,IM 990096,CO,76.0,M,Just a question regarding accessing web site for reporting. All good no adverse affects.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/28/2021,5.0,PUB,,none,none,,None,['No adverse event'],1,MODERNA, 990097,CT,25.0,F,"Fever, treated with ibuprofen 400 mg evry 4-6 hours, fever resolved in 24 hours Acid Reflux/Heartburn, treated with sodium bicarbonate, still ongoing 4 days after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/29/2021,2.0,SCH,Ibuprofen,None,None,,None,"['Dyspepsia', 'Gastrooesophageal reflux disease', 'Pyrexia']",2,MODERNA,IM 990098,CA,74.0,M,Pt is a 74 year old male who had his 1st dose of Pfizer today. Approximately 20 minutes after having his vaccination he was sitting in a chair getting ready to leave observation when he complained of heart burn with no other associated symptoms. Patient was assesed and released via the AMA process. Patient had symptoms decrease in severity during assesment. Additionally a full set of vital signs including a 12 lead were obtained. 12 lead was negative for any signs of a cardiac event. Pt refused transportation to the emergency room via ambulance. Patient was assited to the back of Fire Paramedic Ambulance for further evaluation. Refer to patient care report.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/31/2021,01/31/2021,0.0,OTH,Vistalek,denies,AFIB,,"iodine, contrast,","['Dyspepsia', 'Electrocardiogram normal']",1,PFIZER\BIONTECH,IM 990099,CA,66.0,F,"Pt is a 66 year old female who had her 1st dose of Pfizer today. Approximately 15 minutes after having the vaccination, she was sitting in her car getting ready to leave observation area when she complained of tingling in her mouth with no other associated symptoms. Patient was assesed and released. Patient had symptoms decrease in severity during assesment. Additionally a full set of vital signs were obtained. Refer to 2021-002288 for further details.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/31/2021,01/31/2021,0.0,OTH,Lorazopam,denies,"AFIB, Fibromyalgia, anxiety",,Sulfa,['Paraesthesia oral'],1,PFIZER\BIONTECH,IM 990100,CA,85.0,F,"Pt is a 85 year old female who had her 1st dose of Pfizer today. Approximately 30 minutes after having the vaccination, she was sitting in her chair getting ready to leave observation area when she complained of a dry throat with no other associated symptoms. Patient was assesed and released via the process. Patient had symptoms decrease in severity during assesment. Additionally a full set of vital signs were obtained. Refer to POD 1's patient care report for further details.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/31/2021,01/31/2021,0.0,OTH,Unknown,denies,"Pacemaker, 5 stents",,"Sulfa, shellfish",['Dry throat'],1,PFIZER\BIONTECH,IM 990101,WI,38.0,F,"Vomiting for 12 hours, diarrhea for 24 hours, headache/migraines for 7 days, body aches for 7 days, extreme fatigue, slept for 28 hours at one time, no appetite, runny nose, fever, chills,.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/22/2021,1.0,UNK,"Effexor 150mg, sumitriptan 50mg, propranolol 120mg,",None,Migraines,,Penicillin and walnuts,"['Chills', 'Decreased appetite', 'Diarrhoea', 'Fatigue', 'Headache', 'Migraine', 'Pain', 'Pyrexia', 'Rhinorrhoea', 'Somnolence', 'Vomiting']",1,PFIZER\BIONTECH,SYR 990102,WA,42.0,F,"10 minutes after injection had tachycardia, anxiety, dizziness that lasted for about 15 minutes before resolving with some residual left cheek numbness. Had swollen area around injection site for next four days with intense itching, as well as pain ar injection site. On day 11 post vaccination, developed a rash on injection site covering the area that was previously swollen, approximately 3 inches in diameter as well as tender lymph nodes in left armpit.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,PVT,"Dulera, magnesium, vitamin D and K, Quercetin",,"Sjogrens, asthma",,Levaquin,"['Anxiety', 'Dizziness', 'Hypoaesthesia', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Lymph node pain', 'Tachycardia']",1,MODERNA,IM 990103,NV,34.0,F,"I became very tired almost immediately after my second dose, and proceeded to take a 3 hour nap. Upon waking up from the nap, I had full body aches, joint pain, a headache, and a low grade fever. Said symptoms have now lasted over 24- hours",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,PUB,"Singulair, escitolopram, heather birth control, advair, Allegra, vitamin D, vitamin B complex",None,Hypo thyroidism,,Dairy,"['Arthralgia', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 990104,CA,76.0,F,"Large red area on upper arm around shot location. The upper boundary was rounded on top, vertical on the sides, and a relatively straight line across the bottom. It is about 3 inches long and 1 1/2 inches wide, and was a little swollen yesterday but not much today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/28/2021,7.0,OTH,"Vitamin D and Calcium, Areds2, Pro-5 probiotic, Quercetin, Luteolin",None,None,,Some plastic products,"['Injection site erythema', 'Injection site swelling']",UNK,MODERNA, 990106,AZ,42.0,F,"1/21/21 covid vaccine 1/23/21 covid positive test at work 1/31/21 hospitalized - remdesivir, dexamethasone.",Not Reported,,Not Reported,Yes,,Not Reported,,01/21/2021,01/31/2021,10.0,PHM,,,,,Amoxicillin-rash,"['COVID-19', 'SARS-CoV-2 test positive']",1,MODERNA,IM 990107,NY,50.0,F,"Red, itchy rashes resembling ""goose bumps"" or poison ivy on both arms including both shoulders, both upper arms, both forearms, both wrists. The left and right arms have almost identical patterns. It is not only in the arm that got the injection. Rashes are also on both legs and shins. The rashes appeared approximately 5-6 days after the first dose on Jan. 18 and continue to spread .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/23/2021,5.0,SCH,,None,None,,None,"['Rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,SYR 990108,OR,28.0,F,"Very sore arm for 2 days. Third day showed much improvement, just some mild tenderness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PVT,None,None,None,,Penicillin,['Pain in extremity'],1,MODERNA,SYR 990109,AZ,23.0,F,"Symptoms: 01/29/2021 @ 11:21 AM: Shortness of breath, chest pain, and weakness. Two hours later, chest pain began to feel like chest tightness. Continued for the rest of the day. 01/30/2021: Mild irritation when breathing. Getting out of breath when minimal effort in an activity. A sensation of an increased heartbeat when in reality, it would be 92 BMP. General weakness and dizziness. 01/31/2021: Same symptoms as mentioned. While taking a deep breath, I feel a mild pain around my heart.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,PUB,Cetrizine 10 mg Citalopram 20 mg,,None.,,NKDA,"['Asthenia', 'Chest discomfort', 'Chest pain', 'Dizziness', 'Dyspnoea', 'Dyspnoea exertional', 'Pulse abnormal']",2,PFIZER\BIONTECH,SYR 990110,CO,55.0,F,Shortly after receiving vaccination -- staff advised me of Macroler papular rash at injection site. This rash continued to spread to entire body surface. Two doses of Benadryl 25mg were given then 911 was called to transport patient to local hospital for further evaluation,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,SEN,None,None,"Stable Seizure disorder, Hyperopia,",,Unknown,"['Injection site rash', 'Rash', 'Rash maculo-papular']",1,PFIZER\BIONTECH,IM 990111,CA,51.0,F,"9 days after vaccine left arm posterior mid shaft raised indurated 13x5 cm warm skin lesion. no itching, mildly painful. blotchy skin on volar aspect arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,WRK,"lisinopril, atorvastatin, metformin, albuterol hfa, advair",,"asthma, htn, hyperlipidemia, pre-diabetes",,codeine,"['Induration', 'Pain of skin', 'Rash macular', 'Skin lesion', 'Skin warm']",1,MODERNA,IM 990112,,86.0,F,Fever 101 this evening very mild diarrhea.. this is six days after the shot. Took ASA drinking lots of water,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,PVT,Hydrocodone 10 mg,Bladder infection,Bladder infection,,None,"['Diarrhoea', 'Pyrexia']",1,MODERNA,SYR 990113,WA,24.0,F,"10:00 AM - fatigue, headache, joint pain 2:00 PM - fever and chills 10:10 PM - passed out, approx 5-10 seconds. No memory for 2-3 seconds prior to or 2-3 seconds after passing out. Was caught by partner and no injury from fall occurred.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/31/2021,01/31/2021,0.0,PVT,None,Nasal congestion and sore throat 5 days prior with negative covid test,None,,Sulfa drugs,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Memory impairment', 'Pyrexia', 'Syncope']",2,MODERNA,IM 990114,CA,41.0,M,Patient reported decreased should mobility,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/24/2021,2.0,PUB,,,,,,['Joint range of motion decreased'],1,MODERNA,IM 990115,PA,27.0,F,"Headache, pain/soreness at injection site - both resolved by next day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,PVT,"Lo loestrin fe, multivitamin",Tested covid positive on 1/3/2021,,,,"['Headache', 'Injection site pain']",1,MODERNA,IM 990116,AK,50.0,F,"1/28/21 at 11pm I began feeling overall unwell so I checked my temperature orally as soon as feasible, as I had been traveling on airplane, and I noted fever developing. Overnight I experienced increasing fever and chills, noting fever arriving and staying at 102.4 by middle of the night/very early on 1/29/21. Experienced intense headache and whole body aches. On the morning of 1/29/21 when I got out of bed I felt nauseated and vomited. I still had fever of 102, chills, intense headache and whole body aches. I went back to bed and stayed there until the morning of 1/30/21 continuing to experience all the same symptoms. By 8pm on 1/29/21, I needed relief so I took 500mg acetaminophen. I took 500mg acetaminophen again at 1am and again at 9am on 1/30/21. When I got out of bed the morning of 1/30/21 I noted I still had fever but it was lower at 100.4. On 1/31/21 fever has gone but headache, fatigue and body aches with general feeling of not feeling well.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,PVT,"multi-vitamin, vitamin D3, Cymbalta, losardan, buspirone, gabapentin",none,"complex post traumatic distress disorder (cPTSD), high blood pressure related to cPTSD",,none,"['Chills', 'Fatigue', 'Headache', 'Malaise', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 990118,MN,24.0,F,"After the second dose I woke up on 1/18/21 at 7:30 AM with extreme body and joint pain, a 102�F fever, a migraine with sensitivity to light and sound, dizziness, weakness and ear pain. Fever broke on 1/19/21 at approximately 11:30PM. I had a low grade fever, migraine, some body and joint pain, ear pain, dizziness and weakness. By 1/20/21 I had no fever, little body and joint pain, slight headache and still intense weakness and dizziness, and very intense ear pain. After 1/20/21, only the ear pain, slight arm pain, weakness and dizziness remained until 1/25/21. As of today 2/1/21 I have diagnosed auditory neuritis but no other symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/17/2021,01/18/2021,1.0,PVT,"Claritin 10mg, Vitamin D, probiotic, venlafaxine XR 225mg, Wellbutrin SR 150mg",No,"PTSD, Major Depression, Generalized Anxiety Disorder, Panic Disorder, recurrent UTIs, seasonal allergies",,Grass and bleach,"['Arthralgia', 'Asthenia', 'Dizziness', 'Ear pain', 'Hyperacusis', 'Migraine', 'Neuritis', 'Pain', 'Photophobia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 990119,FL,56.0,F,Made my hair fall out starting about two weeks after the first injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/21/2021,14.0,PVT,carvedilol; Topamax; omeprazole; paroxetine; trazodone; levothyroxine; biotin; magnesium; Montelukast; bentyl;,none,hypertension; hashimoto's thyroiditis; migraine headaches; environmental allergies;,,opiates; biaxin,['Alopecia'],1,MODERNA,IM 990120,HI,48.0,F,Within 5 mins of vaccine I felt my chest tightening. I could still breathe but I could tell my lungs were tight. Taking a deep breath was not normal. Soon after I felt the muscles between my shoulder blades starting to tighten as well. I think a response to my tightness in my chest. We were instructed to stay in facility for 15 mins. My symptoms did not increase after 15 mins so I went home. That was 5:00pm. By bedtime at 10:00pm my symptoms had resolved. I?m not sure if I should get my second dose?,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,PVT,Advil,None,Endometriosis,,"Shellfish, cats, dogs, hay/grass, pollen, dust mites","['Chest discomfort', 'Immediate post-injection reaction', 'Muscle tightness', 'Respiration abnormal']",1,PFIZER\BIONTECH,SYR 990121,WA,45.0,F,"nausea, emesis, syncope, as well as extended tiredness, headache, joint pain, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,PVT,none,none,none,,,"['Arthralgia', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia', 'Syncope', 'Vomiting']",2,PFIZER\BIONTECH,IM 990122,CA,69.0,M,"Chills, high temperature (102-104), fatigue, headache. Treatment: Ibuprofen (initially), switched to Aspirin; beginning 1 every four hours, after two doses switched to 2 every four to 6 hours. Outcome: temperature subsided by morning of 1-31. Headache continued but handled with Aspirin.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,UNK,"Losartan 100mg, Amlodipine 5mg, Aspirin 81 mg EC tablet, triamterene-hydrochlorothiazide 37.5-25 mg per capsule",None,"hypertension, controlled by medication, Stage 3 Kidney Disease",Minor temperature increase with some vaccines when traveling to country regularly,None,"['Body temperature increased', 'Chills', 'Fatigue', 'Headache']",1,MODERNA,IM 990123,OR,48.0,F,"After 9 days, developed redness, itch, swelling, hot to touch, sore big area on arm where injection given.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/30/2021,8.0,OTH,"Lexapro, np thyroid, atarax, vitamin D",,,,Sulfa antibiotics,"['Erythema', 'Pruritus', 'Swelling', 'Vaccination site pain']",1,MODERNA,IM 990124,CA,36.0,F,Injection site soreness for 2 wks. Injection site looked similar to a mosquito bite (mild) in that I can see the where the needle injection was for up to a week. Soreness was limited to the injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/14/2021,1.0,PUB,None,None,None,,Peaches,['Injection site pain'],1,MODERNA,IM 990125,NH,74.0,M,Fatigue lasted 2 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,PVT,,,"Heart, obesity, diabetes.",,,['Fatigue'],1,MODERNA,SYR 990126,MD,50.0,F,"Moderate left Ear, head, and sore throat pain/stuffiness started 1/28/21 with fever of 100.7 with Severe chills and muscle aches, fatigue and arm pain, along with activation of migraine. On 1/30/21, I went to urgent care with concerns over ear and throat pain and redness/pain at injections site to rule out an infection at these sites. The physician said ear and throat showed no signs of infection, the arm redness was still in the expected normal reaction range, but I had Swollen left neck lymph nodes. The doctor said I should Report that as an adverse effect. Advised to take Tylenol - motrin, and hydrocortisone cream for arm if needed .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/28/2021,1.0,WRK,Multivitamin,Left wrist ligament injury,"Migraines, plantar fasciitis, borderline high blood pressure.",,Sulfa medications,"['Chills', 'Ear pain', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Lymphadenopathy', 'Migraine', 'Myalgia', 'Oropharyngeal pain', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 990127,MD,32.0,F,"Approximately 1 hour after injection I developed chest tightness, burning eyes, scratchy throat and hives. No anaphylaxis. If Benadryl was not taken regularly the hives would return for the first 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PUB,"Prescription: Amethia Lo, Lisinopril, Ibuprofen OTC: B Complex, Calcium + Vit D, Women's Multivitamin, Power C chewable, Power Zinc chewable, Hair, Skin & Nails chewable",None,"Scoliosis, HBP",,"Ceclor, Penicillin, Augmentin, Keflex, Ceftin, Doxycycline, Erythromycin, Biaxin","['Chest discomfort', 'Eye irritation', 'Throat irritation', 'Urticaria']",1,MODERNA,IM 990195,IN,25.0,F,"Low grade fever, chills, muscle aches, headache, fatigue, and cold sore on bottom lip",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/29/2021,28.0,PVT,None,None,Right bundle branch block and sinus arrhythmia,,Nickle,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Oral herpes', 'Pyrexia']",2,MODERNA,SYR 990198,,33.0,F,"During cardiovascular exercise experienced SOB, Dyspnea, Chest pain, during and for 1-2hrs post cardio exercise. this continued for 2-3 days. with fatigue, sob,. Pt. had EKG performed which showed 1st degree AV block w RBBB. Pt. was then referred to cardiology where she was seen and diagnosed on 27Jan with pericarditis. Pt has since started NSAID therapy with mild symptoms persisting. Pt. will have Cardiology follow-up at 4weeks time.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/14/2021,5.0,MIL,"Nexplanon, prenatal vitamin, Lunesta PRN",None,None,,NKA,"['Atrioventricular block first degree', 'Bundle branch block right', 'C-reactive protein', 'Chest pain', 'Dyspnoea', 'Electrocardiogram abnormal', 'Fatigue', 'Full blood count', 'Lipids', 'Metabolic function test', 'Pericarditis', 'Red blood cell sedimentation rate']",1,MODERNA,IM 990200,,38.0,F,"Day 1 (day of vaccination): Within 15 minutes of receiving the jab i experienced heart palpitations, fever, dizziness, a dry mouth/throat and heat in my head/upper body. After being discharged from recovery an hour later i returned home but felt very anxious all night. Heart palpitations continued on and off. Day 2: Severe cramp/pain started in my arm, neck and shoulders. Headache. Sweating. Days 3 & 4: Flu symptoms; headache, shivers/fever, runny nose, sore throat, cough, severe muscle and joint pain. Skin was so sensitive to touch i could not wash. Muscles hurt so much i could not move around. Extreme fatigue. Days 5 & 6: Cold symptoms started to resolve. Muscle and joint pain still very severe - difficulty walking/moving around, stiffness and aches in every part of my body. Extreme fatigue. Days 7, 8 & 9: Cold symptoms gone. Muscle and joint pain still severe. Extreme fatigue. Day 10: Pain in muscles started to resolve but not in joints. Fatigue still present. Day 11: Fatigue starting to resolve, joints still very sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,PVT,None,None,Coeliac Disease (auto-immune disorder),,"Wheat, Gluten","['Anxiety', 'Arthralgia', 'Chills', 'Cough', 'Dizziness', 'Dry mouth', 'Dry throat', 'Fatigue', 'Feeling hot', 'Gait disturbance', 'Headache', 'Hyperhidrosis', 'Influenza like illness', 'Myalgia', 'Neck pain', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Palpitations', 'Pyrexia', 'Rhinorrhoea', 'Sensitive skin']",1,PFIZER\BIONTECH,SYR 990310,PR,46.0,F,"severe headache; severe neck pain; severe arm pain; fever at 103 degrees F; Swollen lymph node; bleeding gums; small hematomas on legs; extremely hot diarrheas; horrible burning sensation; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EJ1686, expiration date was unknown), via an unspecified route of administration on the left arm on 08Jan2021 at 14:15 at a single dose for COVID-19 immunization administered at the hospital. She received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EK5730, expiration date was unknown) via an unspecified route of administration on the left arm on 18Dec2020. Relevant medical history included known allergies to shellfish. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. On 09Jan2021 at 12:00 AM, the patient experienced severe headache, severe neck pain, severe arm pain, fever at 103 degrees Fahrenheit (F), swollen lymph node, bleeding gums, small hematomas on legs, and extremely hot diarrheas that she had this horrible burning sensation. The patient did not receive any treatment for the adverse events (AE). The patient underwent further lab tests and procedures, which included COVID test via nasal swab post vaccination on 13Jan2021, which resulted negative. The patient was recovering from all the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Shellfish allergy,,,"['Burning sensation', 'Diarrhoea', 'Gingival bleeding', 'Haematoma', 'Headache', 'Lymphadenopathy', 'Neck pain', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH, 990311,PR,54.0,M,"Uncontrolled short rhythmic breathing; brief electric shock sensation; little sporadic back spasms; strong head pressure sensation; depression symptoms; This is a spontaneous report from a contactable Other HCP reporting for self. A 54-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 09:00 at single dose for covid-19 immunisation. The patient medical history was not reported. Patient received first dose of bnt162b2 on 17Dec2020 09:00. The patient's concomitant medications were not reported. The patient experienced Uncontrolled short rhythmic breathing, brief electric shock sensation and little sporadic back spasms, strong head pressure sensation, depression symptoms currently persistent and decreasing gradually on 09Jan2021. Patient had Nasal Swab on 12Jan2021 with negative result. Outcome of events was recovering. Patient received treatment for all events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,PVT,,,,,,"['Depression', 'Head discomfort', 'Muscle spasms', 'Paraesthesia', 'Respiration abnormal']",2,PFIZER\BIONTECH, 990366,SC,72.0,M,"injection site swelling (size of dime); TThe one at the injection site itself, was an injection site swelling about the size of a dime, ""a red area""/at the site where the shot was administered he has some red streaks; red streaks running from the site up to his neck and shoulder. It is very small. It looks like if he took a ball point pin and drew some lines; This is a spontaneous report from the Medical Information Team. A contactable consumer reported that a 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: ELO142, via an unspecified route of administration from 13Jan2021 11:00 at SINGLE DOSE for COVID-19 immunization. Medical history included haemochromatosis diagnosed in the mid 90's and wa reported as hereditary it was too much iron in the blood, he goes once a month for therapeutic phlebotomy to reduce the iron in the blood; very rare bacterial infection called Arupense from an unknown; he has a slight case of asthma but mentioned that it was related to living on the coast with the mold and moisture and also has a little wheezing. Concomitant medications included ethambutol, montelukast, pravastatin, amlodipine; hydrochlorothiazide, lisinopril; colecalciferol (VITAMIN D), acetylsalicylic acid (ASPIRIN (E.C.) and rifampin for infection and blood pressure medications. Patient had the first dose of the vaccine yesterday 13Jan2021. He has no discomfort, but at the site where the shot was administered, he has some red streaks running from the site up to his neck and shoulder. It was very small. It looks like if he took a ball point pin and drew some lines. However, the patient's wife said it was bigger than a ball point pen. It was jagged lines. The one at the injection site itself, the injection site swelling was about the size of a dime, a red area. He only discovered the red streaks about an hour ago on 14Jan2021, so there has not been no radical change. Patient has concerns; he wanted to know if he should seek medical advice. ""Is it just a rash?"", he asked. His doctor doesn't know about this yet. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/14/2021,1.0,PVT,ETHAMBUTOL; MONTELUKAST; PRAVASTATIN; AMLODIPINE; HYDROCHLOROTHIAZIDE;LISINOPRIL; VITAMIN D [COLECALCIFEROL]; ASPIRIN (E.C.); RIFAMPIN,,Medical History/Concurrent Conditions: Asthma (related to living on the coast with the mold and moisture); Bacterial infection; Blood pressure abnormal (concomitant medication indication (blood pressure medication)); Hemochromatosis (diagnosed in the mid 90's and); Phlebotomy (He goes once a month for therapeutic phlebotomy to reduce the iron in the blood); Wheezing,,,"['Erythema', 'Injection site erythema', 'Injection site streaking', 'Injection site swelling']",1,PFIZER\BIONTECH, 990367,AL,31.0,M,"been in contact with someone who is Covid-19 positive; Chest tightness; Low grade fever; Vomiting; Cough; has been sick since getting the vaccine; tired and fatigue; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 11Jan2021 at a single dose for front line worker (covid-19 immunization). Medical history included ongoing HIV since 2015. There were no concomitant medications. The patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for front line worker (covid-19 immunization). The patient reported that he received his second dose of the Pfizer-BioNTech Covid-19 Vaccine last Monday (11Jan2021) between 8:00 am and 8:30 am, and since then he has been sick and has been experiencing some side effects. He mentioned that he has been in contact with someone who is Covid-19 positive on an unspecified date. He works at the front desk registration in a hospital. He has been tired and fatigued, has had a low-grade fever, vomiting, headache, cough and chest tightness. He added that on Monday evening (11Jan2021), he became tired and fatigued. He had an on and off fever on Tuesday (12Jan2021). He started vomiting while coughing on 12Jan2021. He went to the doctor last night (13Jan2021) and he said he got tested for Covid-19 on 13Jan2021, but the results came out negative. The physician said that it would. However, his physician said that it was too early to tell if he has been infected since he has just been exposed last Monday. Normally, they like to have a 5 day turn around for a true reading. He said his physician told him he just needed to quarantine. He mentioned that his chest feels tight when he coughs on 13Jan2021. When he had to take deep breaths while the doctor was listening to him breath his chest was tight. He had blood work drawn at the doctor's office, but he does not have any results to provide. The patient wanted to know what he needs to do about this. He was inquiring if there any recommendations. He is probably negative because he is symptomatic. His employer said it may be a reaction from the shot. The outcome of the events sickness and exposure to COVID-19 were unknown, as for the event vomiting was recovered on 12Jan2021 while the outcome of the other events was not recovered. � The following information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,UNK,,HIV infection (Verbatim: HIV),,,,"['Chest discomfort', 'Cough', 'Exposure to SARS-CoV-2', 'Fatigue', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting']",2,PFIZER\BIONTECH, 990368,LA,83.0,F,"swollen lips; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; chills and shaking; chills and shaking; red dot on the inside of her throat; she took the Benadryl thinking it was an allergic reaction; swelling on left side where the nodule was removed; burning sensation in her left arm; ear pain; nausea; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on Left deltoid (upper left arm) on 13Jan2021 14:00 at single dose to prevent COVID. Medical history included sulfa drug reaction, high blood pressure diagnosed in 1970s or 1980s (States she was in the hospital in the 70s or 80s. She has high blood pressure which has been difficult to control, she is seeing a cardiologist and he is content with her blood pressure readings, her diastolic is normal), incontinence, thyroid nodule surgery a year ago (2020), thyroid nodule, ten operations in the last 3 years, tightening in her neck repeatedly since her thyroid nodule surgery, scratchy throat problems since a week prior to getting the vaccine (from Jan2021) and post nasal drip and she has had that for years and when they operated nothing worked. The patient's concomitant medications were not reported. The patient previously took cipro where she could not breathe. She does not have lot, ndc or expiration date to provide for any of the medications mentioned that she had a reaction to. She took the Asiatic flu shot in 1958 (as reported), she had a reaction and high fever, weak and pale. This occurred when she was 19 years old. She took the Pfizer covid 19 shot last Wednesday. She stated that it could be her but she got a few of the reported side effects. What she found most important was that she had swollen lips that started about an hour after receiving the vaccine. Last night (13Jan2021) she got the chills and was shaking during the night. She had mild chills in the last few days, during the night she was shaking from the chills but it may have been cold at night, reporting the chills have subsided but she can feel it a little bit. In Jan2021, she felt a burning sensation in her left arm which lasted about two minutes. She got a piercing earache in her left ear for about two minutes and then it went away. She experienced nausea within two minutes, but she ate the ginger candy she had in her purse and her nausea went away. She could have something else too since she has a red dot on the inside of her throat. She did not see it was red before last night (13Jan2021). She took Benadryl on Wednesday afternoon after she called the doctor's office, she took the Benadryl thinking it was an allergic reaction, her swollen lips seemed like it was improved but now it was minor. She has had the tightening in her neck repeatedly since her thyroid nodule surgery but she felt the tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening, it is sort of still ongoing but states it has sort of improved. Patient also mentioned swelling on left side where the nodule was removed. She was asking if she should get the second dose. She has an appointment for her second dose. She has never had much problems till she was 80. Her husband tested negative for covid and she tested negative in Aug2020 prior to one of her surgeries. Patient stated that she is 83 but she is biologically younger. She felt pretty good normally. The events did not require emergency room visit or physician office visit. No prior vaccinations (within 4 weeks). The outcome of the events burning sensation in her left arm, ear pain and nausea was recovered in Jan2021; Swollen lips, tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening, chills was recovering; and unknown for the other events. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/01/2021,,PVT,,,Medical History/Concurrent Conditions: Blood pressure high; Hospitalization; Incontinence; Neck tightness (tightening in her neck repeatedly since her thyroid nodule surgery); Postnasal drip; Sulfonamide allergy (she has a sulfa drug reaction); Surgery (She has had ten operations in the last 3 years.); Throat irritation (since a week prior to getting the vaccine); Thyroid nodule; Thyroid nodule removal (a year ago),,,"['Burning sensation', 'Chills', 'Condition aggravated', 'Ear pain', 'Lip swelling', 'Muscle tightness', 'Nausea', 'Pharyngeal erythema', 'SARS-CoV-2 test negative', 'Swelling', 'Tremor']",1,PFIZER\BIONTECH,OT 990369,CA,37.0,F,"Painful Lymphadenopathy in the vaccinated arm and same side of the neck; This is a spontaneous report from a contactable physician (patient). A 37-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246) intramuscular in the left arm on 12Jan2021 07:15 AM at a single dose as Covid vaccine. The patient had no medical history. She has no known allergies. Concomitant medications were not reported. The patient had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685) intramuscular in the left arm on 22Dec2020 12:45 AM as Covid vaccine. She had no other vaccine in four weeks. She experienced painful lymphadenopathy in the vaccinated arm and same side of the neck that started 24hrs post vaccine on 13Jan2021 07:15 AM. Treatment was not received for the event. She has no Covid prior to vaccination. She did not have Covid tested post vaccination. The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Lymphadenopathy'],2,PFIZER\BIONTECH,OT 990370,KY,49.0,F,"I had a bowel movement and lots of blood; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJI686), via an unspecified route of administration in the right arm on 11Jan2021 at 12:45 as a single dose for COVID-19 immunization. Medical history included arthritis and migraines. The patient had no other vaccines within four weeks and did not have COVID prior to the vaccination. Concomitant medications (reported as other medications in two weeks) included fexofenadine hydrochloride (ALLEGRA) and paracetamol (TYLENOL). On 13Jan2021 at 12:00 AM, the patient had a bowel movement and lots of blood and also on 15Jan2021, she had a bowel movement with blood. The patient was not treated for the event. The patient had not tested positive for COVID post vaccination. Outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/13/2021,2.0,UNK,ALLEGRA; TYLENOL,,Medical History/Concurrent Conditions: Arthritis; Migraine,,,['Haematochezia'],1,PFIZER\BIONTECH, 990371,NC,46.0,F,"Acute asthma attack; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), intramuscular in the left arm on 15Jan2021 07:45 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced acute asthma attack on 15Jan2021 08:00. This adverse event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of acute asthma attack and included treatment with albuterol inhaler. Outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,PVT,,,,,,['Asthma'],1,PFIZER\BIONTECH,OT 990372,NY,,M,"tested positive for covid on 12Jan, is asymptomatic, and tested negative after two days; tested positive for covid on 12Jan, is asymptomatic, and tested negative after two days; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID vaccine on 30Dec2020 and was supposed to take the next dose on 20Jan2021. However he tested positive for COVID on 12Jan2021 and was asymptomatic, and tested negative after two days on 14Jan2021. He wanted to know if he can take the second dose even if he tested positive. The outcome of the event was recovered on 14Jan2021. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/12/2021,13.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test negative', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990373,AZ,,F,"I received the first dose of the Pfizer vaccine on 30Dec2020 and got covid on 04Jan2021 via positive nasal swab test; I received the first dose of the Pfizer vaccine on 30Dec2020 and got covid on 04Jan2021 via positive nasal swab test; This is a spontaneous report from a from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (Lot number and Expiration date not provided), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient had her first dose of COVID vaccine on 30Dec2020. She had a positive COVID test via Nasal swab test on 04Jan2021. She will be off of quarantine on 18Jan2021. For some reason her second dose of COVID Vaccine is not scheduled until 29Jan2021. She asked if she is COVID positive when should she get that next dose; and also the second dose scheduled her out 30 days which is a long time which she was questioning that as well. The outcome of the events was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/04/2021,5.0,UNK,,,,,,"['Inappropriate schedule of product administration', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990374,FL,73.0,F,"Not feeling great; Slight headache; Breathing is heavier; Below her breast line is a tightness she can't really describe; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: SL3246), via an unspecified route of administration in right arm, on 12Jan2021 at 10:45, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took varicella zoster vaccine (SHINGLES VACCINE) for immunization and had a little reaction but just the normal things. On Tuesday morning, the patient got the COVID-19 shot and was fine. This morning (15Jan2021), the patient was not feeling great, has a slight headache, her breathing is heavier, and below her breast line is a tightness she can't really describe. The patient asked if these were a side effect of the COVID-19 vaccine and wondering if this is normal. As a treatment for the events, the patient took paracetamol (TYLENOL). The patient asked if she can or should get a test, a COVID-19 test. It has been so many days since having the vaccine, 4 days later, she is wondering if she might have COVID-19. The patient isn't sure and is just asking a question. It is confirmed that she has not had a test or tested positive for COVID-19. The outcome of ""Not feeling great"" was unknown. The patient had not recovered from the remaining events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/15/2021,3.0,UNK,,,,,,"['Feeling abnormal', 'Headache', 'Respiration abnormal', 'Skin tightness']",UNK,PFIZER\BIONTECH, 990375,,,F,"received first dose of vaccine and then tested positive for SARs-Cov-2; received first dose of vaccine and then tested positive for SARs-Cov-2; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of vaccine and then tested positive for SARs-Cov-2 on an unspecified date. The patient was asking about the efficacy. Outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990376,,,F,"got tested and tested positive; got tested and tested positive; lethargic; This is a spontaneous report from non-contactable consumer. This consumer reported similar events for two patients (husband and wife). This is the first of two reports (for the wife). A 72-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 04Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, reported as two days after, the patient was lethargic. A week ago on an unspecified date, reported as past Monday, she had no cough, no fever, received azithromycin, got tested and tested positive. She wanted to know if they can receive the second dose and the timing of the second dose of vaccine. The patient underwent laboratory tests and procedures which included SARS-CoV-2 test: positive on an unspecified date. Outcome of the events was unknown. No follow-up attempts are possible. Information about the lot/batch cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046180 same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,,,UNK,,,,,,"['COVID-19', 'Lethargy', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990377,TX,,F,"heart rate increased to 150; nausea; headache; jittery; coldness; lightheaded; weakness; legs felt light; fever last night (very hot and thirsty); very hot; thirsty; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the COVID vaccine yesterday on 14Jan2021 and after 1 or 2 minutes of receiving it, her heart rate increased to 150, she felt nausea, headache, jittery, coldness, lightheaded, weakness, legs felt light , fever last night (very hot and thirsty) and today she does not feel 100%. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/14/2021,0.0,UNK,,,,,,"['Asthenia', 'Dizziness', 'Feeling abnormal', 'Feeling cold', 'Feeling hot', 'Feeling jittery', 'Headache', 'Heart rate increased', 'Limb discomfort', 'Nausea', 'Pyrexia', 'Thirst']",1,PFIZER\BIONTECH, 990378,,,F,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable other healthcare professional (patient). This female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 11Jan2021, the patient started developing symptoms such as loss of smell and, on 12Jan2021, she tested positive for COVID from 2 rapid tests and a PCR test. The outcome of the events was unknown. The information on Lot/Batch number has been requested.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (7 days in this case). However, a causal relationship between event ""positive COVID-19 test with symptoms"" (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/12/2021,8.0,UNK,,,,,,"['Anosmia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990379,NY,53.0,F,"second vaccine was scheduled supposedly on 13Jan2021 but was rescheduled to 19Jan2021; supposedly on 13Jan2021 but was rescheduled to 19Jan2021; received the first dose on 23Dec2020 and tested positive for COVID RNA test nasopharyngeal swab; received the first dose on 23Dec2020 and tested positive for COVID RNA test nasopharyngeal swab; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs). A 53-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; strength: 30 mcg, lot number: EK9231) via an unspecified route of administration in the left deltoid on 23Dec2020 at 0.3mL, single dose for covid-19 immunisation. There were no medical history and no concomitant medications. The patient received the first dose on 23Dec2020 and tested positive for COVID RNA test nasopharyngeal swab on 11Jan2021. The outcome of the event was not recovered. Her second vaccine was scheduled supposedly on 13Jan2021 but was rescheduled to 19Jan2021 because they didn't allow her to go to the hospital while she was positive. She wanted to know if this was recommended. She just wanted some advice on getting the second vaccine, and how does it affect efficacy because she didn't get it on day 21.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 23Dec2020, and tested positive for COVID RNA test nasopharyngeal swab on 11Jan2021. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/11/2021,19.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990380,MI,77.0,F,"experienced allergic reactions; her eyes got red; Her eye lids were red; Her eye lids were red, swollen, and puffy.; Her eye lids were red, swollen, and puffy.; cheeks were bright red; This is a spontaneous report from a contactable nurse (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration on the left arm on 14Jan2021 14:00 at a single dose for Covid-19 immunization. Medical history included that the patient was diabetic and hypertensive; both were ongoing. Concomitant medications included atenolol taken from 14Jan2021 for blood pressure high; pioglitazone hydrochloride (ACTOS) and ongoing metformin both were taken from an unspecified date for diabetes; ongoing montelukast sodium (SINGULAIR) for history of food and drug allergies and ongoing chlorothiazide for diuretic. It was reported that she had the first dose of the covid vaccine on 14Jan2021 and experienced allergic reactions after she left the facility; they were not life threatening but were not pleasant. She realized how bad it was after she got in the car, removed her mask, and looked at her face. She was concerned about getting the second dose. She even took Benadryl 1 hour before getting the shot and still had a reaction. She clarified her allergic reaction to be as her eyes got red. Her eye lids were red, swollen, and puffy. It looked bad. When she got in the car took her mask of her cheeks were bright red. She sat in the ER parking lot for an hour waiting for it to resolve. It resolved after like an hour and half. After it resolved and went away she went back home. She stated that this allergic reaction is anxiety producing. She gets anxious because she knew what could happen. The outcome of the events was recovered on 14Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,UNK,ATENOLOL; ACTOS; METFORMIN; SINGULAIR; CHLOROTHIAZIDE,Diabetic; Hypertensive,,,,"['Anxiety', 'Erythema', 'Erythema of eyelid', 'Hypersensitivity', 'Ocular hyperaemia', 'Skin swelling', 'Swelling of eyelid']",1,PFIZER\BIONTECH, 990381,,,F,"tested positive for Covid 19; tested positive for Covid 19; lethargic; cough; arm hurt; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter tested positive for COVID 19 this past Wednesday after receiving the first shot on 04Jan2021. She is due for her second shot on 25Jan2021 and is wondering if she can take the second dose if it is already past her quarantine time? The night of receiving her first shot (04Jan2021), her arm hurt that night and went away the following day. She felt a little lethargic and it had gone away. She then wounded up with a cough, went into a walk-in clinic to check the chest and everything was normal. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unspecified date. The outcome of the events arm hurt was recovered on 05Jan2021, lethargic was recovered on an unspecified date, while of the rest was unknown. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,,,,,,"['Cough', 'Lethargy', 'Pain in extremity', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990382,KY,39.0,F,"pleural effusion; This is a spontaneous report from a contactable health care professional (patient). A 39-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL 0142) in the hospital via an unspecified route of administration on 06Jan2021 at 11:15 AM at a single dose on the right arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO), calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS) and ibuprofen (manufacturer unknown) which was given 8 hours before (as reported). The patient previously took morphine and experienced allergies. The patient did not have COVID-19 prior to vaccination. The patient reported that she ended up on the ER on the day of the report diagnosed with a pleural effusion which was reported to have started on 14Jan2021 at 08:00 AM. The doctors are unsure whether it could be related to the vaccine, but she was only 39 years old and have never had something like this happen before. The patient was given azithromycin as treatment for the event. The patient had not recovered from the event. The patient had not been tested for COVID-19 post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/14/2021,8.0,PVT,LEXAPRO; TUMS [CALCIUM CARBONATE;MAGNESIUM CARBONATE;MAGNESIUM TRISILICATE]; IBUPROFEN,,,,,['Pleural effusion'],1,PFIZER\BIONTECH, 990383,,,F,"diagnosed with a COVID-19 infection 2 days after the second dose of the Pfizer's COVID-19 vaccine.; diagnosed with a COVID-19 infection 2 days after the second dose of the Pfizer's COVID-19 vaccine.; This is a spontaneous report from a contactable consumer. A 91-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date, their first dose, via an unspecified route of administration on an unspecified date; both at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was diagnosed with a COVID-19 infection 2 days after the second dose of the Pfizer's COVID-19 vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: diagnosed with a covid-19 infection on an unspecified date (2 days after the second dose of the Pfizer's COVID-19 vaccine). The reporter inquired if the patient could be administrated with a monoclonal antibody infusion for the management of mild COVID-19 symptoms. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 990384,CO,54.0,F,"body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; a little swelling; throat dry at night; joint pain/ankle pain; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 08Jan2021 14:00 at a single dose for COVID-19 immunization. The patient medical history was none. Patient's concomitant medications were not reported. The patient previously took cortisone. It was reported that the patient got the vaccine on 08Jan2021 and started having the headaches right after. Still has some pain in the forehead and temples area. Has had neck pain, overall body aches, joint pain, pain in ankles and legs that still happens with getting up and down from sitting position. Overall pain is improved but still there, still has pain in ankles and legs. Got the shot in the left upper arm and having real bad armpit pain and a little swelling there. It has gotten a little better, but mostly hurts when moving and laying down. Has had a cough since she got the vaccine, it's mostly a dry cough and not really wet and mostly in the morning. She drinks a lot of fluids throughout the day and still has a little cough off and on. During the night her throat is really dry and which causes more coughing which she did not have before the vaccine. They are mostly concerned with the cough and the stuff when read online about the side effects that last about 2-3 days, but these have been since she got the vaccine. They know this is also know and not much known about it or what is normal yet, but they want to know if she could get the second vaccine, would it be okay. It was stated that the seriousness of the events is in the middle of not serious and medically significant. She is worried about the cough since it is ongoing, when reads online the side effects are listed as 2 or 3 days and her side effects have been going on since she got the vaccine which is worrisome. The outcome of the events cough and throat dry was not recovered, event pain was recovering, while the outcome of the rest of the events was unknown. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Axillary pain', 'Cough', 'Dry throat', 'Headache', 'Neck pain', 'Oedema peripheral', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 990385,,,F,"she tested positive for Covid-19; she tested positive for Covid-19; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 28Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last 28Dec2020, but on 04Jan2021, she tested positive for Covid-19. She said she has been quarantined since and was asymptomatic. Patient said she was due to receive the 2nd dose on the 18th of January and wants to know if that was okay. Outcome of the event was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The patient received the single dose of BNT162B2 on 28Dec2020, and was diagnosed with COVID-19 on 04JAN2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. The company considers that the COVID-19 infection is more pre-existing infection prior to vaccine use, and unrelated to BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990387,CA,53.0,F,"tested positive later in the day; tested positive later in the day; exposed to someone with covid virus; headaches in the back of head and ears; heaviness, it seems like pressure; Fever/101.6; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration, administered to the left deltoid, on 14Jan2021 between 2:30-2:45pm (14:30-14:45) at single dose for COVID-19 immunisation. It was offered at her worksite. The patient's medical history included ongoing Baker's cyst right knee. The patient had no family history. Concomitant medication included celecoxib (CELEBREX) from May2020 for Baker's cyst. The patient had no additional vaccines administered on the same date of the BNT162B2. The patient previously took flu shot and she got sick (in the 1980's or 1990's). The patient had no prior vaccinations that were within 4 weeks prior to the first administration date of BNT162B2. The patient, a Senior facility HCP, took a covid test on Monday and was negative. Yesterday (14Jan2021), she received the first dose and then tested positive later in the day. She wanted to know if she can get the next dose at the appropriate time or if she has to wait 90 days. On 14Jan2021, the patient experienced headaches in the back of head and ears, heaviness, it seems like pressure, fever, and exposed to someone with covid virus. It was reported that the patient was debating on getting the Pfizer BioNTech Covid vaccine and so she finally decided to get it yesterday (14Jan2021). Two hours after getting it and getting home, her head started to hurt and fever, which she thought that was typical. That night the fever broke and it started again this morning (15Jan2021). She works at a senior facility and had to ask for an extended medical leave. She was tested yesterday for Covid that morning and had the vaccine in the afternoon. She was exposed to someone with the virus. She knows there are 2 shots and now she has had the one. She wanted to know if it's safe to get the second one since someone said she may need to wait 90 days since being exposed. She still has the headaches in the back of head and ears, heaviness, it seems like pressure. The fever has been under 100, it's been about 99 and the highest it got was yesterday at 101.6 degrees. By the time she went to bed last night it got down to 98.2 degrees. She has alternated Advil and Tylenol. She took temperature at 6am today (15Jan2021) and it was 99.8 and so she took a couple of Advil to help and by 7am it was down to 99.2. So, it's staying in the 99.2-99.3 range. The patient did not receive any other vaccines the same day or 4 weeks prior. The patient mentioned when getting the her very first flu shot, which she was hesitant about getting, she did get sick, but it wasn't immediately after. Since then she has been fine. She thinks this was in the 1980's or 1990's. She mentioned that this is a new vaccine and there is not a lot of information out there. She wanted to know if she will get immunity right away. She mentioned she was tested on Monday for Covid and told if she didn't get a call she was fine and she didn't hear anything. Then was told yesterday she was exposed to someone with Covid and so she had testing again yesterday. She is awaiting results (pending clarification). No further details provided. She was diagnosed around Memorial Day last year for right knee baker's cyst and given celecoxib. She went through physical therapy and has full range of motion, but cyst still there and tender. She may see a rheumatologist. She just finished her 30 days of celecoxib and didn't see any difference. It was reported that the events did not require a visit to emergency room nor physician office. The outcome of the event "" tested positive later in the day"" was unknown while the outcome of the events headaches in the back of head and ears, heaviness, it seems like pressure, fever, and exposed to someone with covid virus was not recovered.; Sender's Comments: The reported tested positive on the same day that the patient received first dose of COVID 19 vaccine, BNT162B2, is considered unlikely related to the suspect. Of note, the patient exposed to someone with the virus.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,UNK,CELEBREX,Baker's cyst (Additional Information for Other Conditions: Right knee),,,,"['Discomfort', 'Exposure to SARS-CoV-2', 'Head discomfort', 'Headache', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990388,CA,29.0,F,"began having symptoms on 09Jan2021 and she had a positive test on 12Jan2021; began having symptoms on 09Jan2021 and she had a positive test on 12Jan2021; This is a spontaneous report from a contactable nurse (patient) reported that a 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on the left arm on 28Dec2020 16:00 at a single dose for safety for herself working with COVID patients. The patient's medical history and concomitant medications were reported as none. The patient asked how she should proceed with her second vaccine dose now that she is positive for covid. The patient received the first dose of the vaccine on 28Dec2020. She was looking for recommendations of what to do about the second dose. She began having symptoms on 09Jan2021 and she had a positive test on 12Jan2021. The outcome of the events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported positive test/having symptoms based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/09/2021,12.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'Occupational exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990389,LA,29.0,F,"the redness came back but it was itchy, hot to touch, and hard; the redness came back but it was itchy, hot to touch, and hard; With my first vaccine I had redness to the site the day after injection; It was probably about a quarter to half dollar in size and was red and inflamed; This is a spontaneous report from a contactable nurse (patient) reported that a 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the right arm on 21Dec2020 17:15 at a single dose for Covid-19 immunization. Medical history included attention deficit hyperactivity disorder (ADD), eczema, and psoriasis; all from an unknown date. Patient was not pregnant. Concomitant medications included vitamin b complex, ergocalciferol (VIT D), and birth control. It was reported that with patient's first vaccine, the patient had redness to the site the day after injection (22Dec2020). It was probably about a quarter to half dollar in size and was red and inflamed but went away and faded as the week went on. Then about a week after that vaccine (reported as '27Dec2020 19:00'), the redness came back but it was itchy, hot to touch, and hard. Over the next day or so it grew quite large. The patient visited a physician, and was placed on an oral antibiotic and it slowly began to fade and go away. The outcome of the events was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,VIT B COMPLEX; VIT D,,Medical History/Concurrent Conditions: ADD; Eczema; Psoriasis,,,"['Injection site erythema', 'Injection site induration', 'Injection site inflammation', 'Injection site pruritus', 'Injection site warmth']",1,PFIZER\BIONTECH, 990390,NC,23.0,M,"rash on his right arm and right leg; it is like little red bumps that kind of itch; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EK9231, via an unspecified route of administration in left arm (top of shoulder) on 12Jan2021 at a single dose for Covid-19 immunization. The patient had no relevant medical history, stated that he is perfeclty healthy. There were no concomitant medications. There were no prior vaccination within 4 weeks.The patient received the first dose of the Covid 19 vaccine on 12Jan2021. It was administered in his left arm; however, he has developed a rash on his right arm and right leg. It's kind of large but it is not oozing or anything. The patient wanted to know if this is a normal side effect. He wanted to know if this a serious allergic reaction. He stated that he got the first dose Tuesday and he is beginning to have, he does not know if it is a mild allergic reaction or just a symptom but he has a rash on his right arm right around the elbow and one his leg it is like little red bumps that kind of itch. In his paperwork it is saying one symptoms that could be severe allergic reaction is a rash all over the body so he is wondering if this is a mild reaction of some sort and also if there are any other cases like this. He first noticed the rash on his arm yesterday (14Jan2021) after he took a shower he looked on his arm and seen a trail going down and today he noticed one on his leg. He noticed the area on his arm yesterday and today he noticed the area on his leg. He says they are little red bumps that itch. He does not know if it was kind of wet but there was a little trail going down and its itchy, it is only the 2 spots that he has noticed are really bad. He says is has persisted he thinks it has remained about the same, he definitely won't say they have gotten worse, they may have swelled up a little bit, he is trying not to scratch but he has scratched a little bit so that is probably why it has swollen up a little bit. The patient has not taken anything for the events; other than using lotion, he was putting lotion on when he first noticed it. The patient had not recovered from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/14/2021,2.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Rash', 'Rash erythematous', 'Rash pruritic', 'Swelling']",1,PFIZER\BIONTECH, 990392,,,F,"hive rash on her body; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no history of allergies. The patient reported on unspecified date, six days after receiving a dose of the covid vaccine, she developed hive rash on her body requiring steroids to treat. Outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Rash', 'Urticaria']",UNK,PFIZER\BIONTECH, 990394,,,F,"Caller received her first shot of the COVID vaccine on 07Jan2021 however tested positive on the 13Jan2021; Caller received her first shot of the COVID vaccine on 07Jan2021 however tested positive on the 13Jan2021; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received her first shot of the COVID vaccine on 07Jan2021 however tested positive on the 13Jan2021. Scheduled for her second dose on 27Jan2021. She asked that will it help or harm to get the second dose of the COVID vaccine with her history of a COVID positive test? She would like to know if she should get her second dose of the COVID vaccine after testing positive for the COVID infection, or not. Events outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/13/2021,6.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990395,,,M,"tested positive on 14Jan2021; tested positive on 14Jan2021; This is a spontaneous report from a contactable nurse (Patient's wife). A male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 26Dec2020 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She states that her husband, who is also an RN, got first dose of the vaccine on 26Dec2020, was exposed to Covid on 09Jan2021, experienced symptoms on 12Jan2021, and tested positive on 14Jan2021. She wants to know if he can still get the 2nd dose which he was originally scheduled to receive on 16Jan2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,01/14/2021,19.0,UNK,,,,,,"['COVID-19', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990396,AZ,42.0,M,"Tested positive symptomatic COVID-19 on 04Jan2021.; Tested positive symptomatic COVID-19 on 04Jan2021.; High grade fever up to 104F after booster dose on first 24 hours with headache; High grade fever up to 104F after booster dose on first 24 hours with headache; This is a spontaneous report from a contactable physician (patient). A 42-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown: EK5730), intramuscularly on left arm on 23Dec2020 at 08:45 AM at single dose for COVID-19 immunization. Medical history included hyperuricaemia and hypertriglyceridaemia. Concomitant medication included fenofibrate and febuxostat. The patient was tested positive symptomatic COVID- 19 on 04Jan2021. Symptoms started 01Jan2021: recovered at home. High grade fever up to 104F after booster dose on first 24 hours in Dec2020 with headache. The patient received other vaccine same date (reported as) on 13Jan2021 as second dose on IM left. The patient did not receive any treatment from events. The outcome of events was recovered on unknown date.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 23Dec2020, and COVID-19 test positive on 04Jan2021. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/01/2020,,PVT,FENOFIBRATE; FEBUXOSTAT,,Medical History/Concurrent Conditions: Hypertriglyceridemia; Hyperuricemia,,,"['COVID-19', 'Headache', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 990398,PA,32.0,M,"came down with COVID-19; came down with COVID-19/Nasal Swab: positive; This is a spontaneous report from a contactable nurse (patient). A 32-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL0140), via an unspecified route of administration on 23Dec2020 at a single dose in right arm for COVID-19 immunization. Medical history included asthma, atrial fibrillation, allergy to wasp. Concomitant medication included flecainide, metoprolol, budesonide, formoterol fumarate (SYMBICORT), albuterol (SALBUTAMOL). The patient previously took CECLOR and acetylsalicylic acid (ASPIRIN), both experienced allergy. There was no other vaccine in four weeks. The patient came down with COVID-19 1 week later on 30Dec2020. The patient had no exposures and no one else around the patient was sick. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. There was a treatment for adverse event: multiple doctor visits, urgent care visit, computerised tomogram (CT) scan: unknown result. There was no COVID prior vaccination. There is a COVID tested post vaccination: Nasal Swab on 03Jan2021: result positive. The outcome of events was not recovered.; Sender's Comments: Based on the information provided, the positive COVID-19 nasal swab test cannot be excluded for the ineffective protection of vaccine BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,12/30/2020,7.0,PVT,FLECAINIDE; METOPROLOL; SYMBICORT; ALBUTEROL [SALBUTAMOL],,Medical History/Concurrent Conditions: AFib; Allergy to insect sting; Asthma,,,"['COVID-19', 'Computerised tomogram', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990401,GA,42.0,F,"Allergic reaction; This is a spontaneous report from a contactable consumer (patient's spouse). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration in the left arm on 14Jan2021 15:00 at a single dose in a hospital for COVID-19 immunization. Medical history included allergy to sulfur and latex. There were no concomitant medications. The patient previously took dexamethasone (DECADRON) and experienced allergy. The patient had Covid vaccine at the hospital yesterday (14Jan2021) about 3pm and around 315-320, she had an allergic reaction. The patient was given epinephrine and stuff like that but ended up having to call an ambulance and took to another hospital. There, they had to put her in ICU and on a ventilator. The patient's spouse asked what might have been in the product that she would have been allergic to. The patient was transferred to hospital. She is a respiratory therapist. The patient was treated with epinephrine, albuterol and she was put on a bi-pap but she couldn't breathe and was told by the doctors that her body can't take it so they intubated her about 7:30 pm, she was put on a ventilator. The patient had an emergency visit. The patient had no prior vaccination (within 4 weeks). The outcome of the event was not recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/14/2021,01/14/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Latex allergy; Sulfonamide allergy,,,"['Bilevel positive airway pressure', 'Dyspnoea', 'Endotracheal intubation', 'Hypersensitivity', 'Intensive care', 'Mechanical ventilation']",UNK,PFIZER\BIONTECH, 990404,PA,57.0,F,"Soreness on the arm/ soreness at the site; felt a little achy/ achiness like you have on flu; I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID; I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID; This is a spontaneous report from a contactable nurse (patient herself). A 57-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140, reporter stated ""could be ELO or ERO""), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included bronchitis from Oct2020 and ongoing and occasional cough. Concomitant medications were not reported. The patient reported that ""I am a nurse I work with COVID patients. I got my vaccination on 28Dec2020. After the vaccination I had soreness on the arm and I felt a little achy. I felt like that with the flu shot (no further clarification) for couple of few days maybe. Then my whole family developed COVID and I am COVID positive. On 06Jan2021, I woke up with every COVID symptoms. I tested positive on the 7th. So, I have been in isolation for 10 days from work. The reason I called you guys is that I am getting 10 different answers. I am due to get my vaccination on 18th. I still have some symptoms and I did not know I am hearing where symptoms go away. I am concerned, my shot is not going to work. If I have mild symptoms can I get it? I am getting tensive for answers, she gave a little bit of information. Do you want me to tell you all my symptoms the time I contracted the COVID? What I told you about the shot was from 28th. Yes, the vaccination on the 28th was soreness at the site like achiness like you have on flu. I had bronchitis (Intent: History) back in at the month of Oct. I have an occasional cough. So, I do not even count that because that is being going on but then I got real sick with positive COVID on the 6th. I am concerned about getting my second shot. That is the reason of my call. The symptoms from the 28th is just what I told you. I have COVID so I am on a lot of medication right now. I am taking medications for the COVID. I am on budesonide (SYMBICORT) inhaler, albuterol (VENTOLIN) inhaler, I am taking acetaminophen (TYLENOL), guaifenesin (MUCINEX). As of Thursday I am taking ranitidine (ZANTAC) and some Steroids, pepper too and cough medicine as needed. When asked about causality, the patient stated ""No because my whole family got COVID. Like my daughter, in-laws. It just went through our whole family. I do not think anything is related to the vaccine."" Nurse added, ""I do not really know what to do about this. If I feel better, I am just wondering if I should go ahead and get it because she told me there is no studies beyond that day. That was my main reason for the call."" She was referring to the 'TCP'. ""When I am going to get it if I am having mild symptoms because I do not want to lose my immunity. I am kind of troubling with myself what to do."" The outcome of the event ""I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID"" was not recovered and of the remaining events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for corona virus infection based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity. It worth to note that the patient's whole family developed COVID.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/07/2021,10.0,UNK,,Bronchitis,Medical History/Concurrent Conditions: Cough,,,"['COVID-19', 'Exposure to SARS-CoV-2', 'Injection site pain', 'Pain', 'Pain in extremity', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990413,,,F,"tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for two patients. This is the second of the two reports. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 31Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. This patient was vaccinated and has tested positive for Covid-19 on an unspecified date, not sure when she tested positive for the Covid-19. She was asymptomatic. It was also reported that she got sick on 03Jan2021. The second dose is due 21Jan2021, is it ok for her to receive it? How long can she wait if she does not get the vaccine at 21 days? The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021051642 same reporter/product, similar events and different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,,,UNK,,,,,,"['Asymptomatic COVID-19', 'Illness', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990421,MI,65.0,F,"I had anaphylaxis yesterday; Throat is still swollen; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus. Concomitant medication included metformin (unknown manufacturer), levothyroxine sodium (LEVOXYL), fluoxetine (unknown manufacturer), empagliflozin (JARDIANCE), rosuvastatin (unknown manufacturer). The patient experienced anaphylaxis and throat was still swollen on 15Jan2021 about 30 minutes after when she received the shot, with outcome of recovering. The patient was transferred to emergency and was treated for the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,UNK,METFORMIN; LEVOXYL; FLUOXETINE; JARDIANCE; ROSUVASTATIN,,Medical History/Concurrent Conditions: Diabetes (Verbatim: Diabetes),,,"['Anaphylactic reaction', 'Pharyngeal swelling']",1,PFIZER\BIONTECH, 990423,PA,,F,"ended up getting coronavirus; ended up getting coronavirus; This is a spontaneous report from the Pfizer marketing program. Information received from a contactable consumer reporting for the mother. A female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. It was reported that the patient took the first dose of the vaccine but ended up getting Coronavirus a week after her first dose. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Coronavirus infection']",1,PFIZER\BIONTECH, 990424,CA,,F,"COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a Pfizer-sponsored program ""Pfizer RXPathways"" from a contactable other health professional. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 virus test positive on 13Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 13Jan2021. The information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,01/13/2021,20.0,UNK,,,,,,"['COVID-19', 'Laboratory test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990429,CO,52.0,F,"fever between 103 to 103 F; Severe body aches; fatigue; generalized weakness; This is a spontaneous report from a contactable physician (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiration date not provided), via an unspecified route of administration in the left arm on 07Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included Meniere's disease, and allergies to Latex. The patient previously took cefalexin (KEFLEX) and codeine and experienced allergies. The patient also took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 17Dec2020 17:30 in the left arm for COVID-19 immunization. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications. On 08Jan2021 03:00, about 10 hours post vaccine, the patient experienced fever between 103 to 103 f, severe body aches, fatigue, and generalized weakness which lasted until about 60 hours post vaccination. The patient has not undergone COVID testing post vaccination. The outcome of the events was recovered on 10Jan2021 15:30.; Sender's Comments: Based on a compatible temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Latex allergy; Meniere's disease,,,"['Asthenia', 'Fatigue', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 990433,PA,,F,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse reporting for herself. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the vaccine and 2 days later developed positive COVID-19 test and go bed. The patient wanted to know how many days she needs to wait until she receives the 2nd vaccine. The outcome of the event was unknown. Information on lot number/batch number was requested.; Sender's Comments: The patient developed positive COVID-19 test two days after vaccination of BNT162B2. No complete protection can be achieved to prevent from the targeted infection/disease due to the very short time lag. The company considers that the COVID-19 is more likely pre-existing condition prior to vaccine use, and unrelated to BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990434,TX,,F,"COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a Pfizer-sponsored program contactable consumer reporting for herself. A 53-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. Medical history included blood pressure. Concomitant medication included losartan (unknown manufacturer) for blood pressure. The patient experienced COVID-19 virus test positive on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive (unknown date). The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,LOSARTAN,,Medical History/Concurrent Conditions: Blood pressure,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990441,FL,66.0,F,"severe upper stomach pains and stomach pains all over and cramps; all over body pain; headache; nausea; ankles swelling more the right one; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration in the right arm on 13Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included Coronary artery disease (CAD), 2nd degree AV heart block, acid reflux, gastritis, high blood presure, fibromyalgia, gammaglobulinemia, allergies to sulfa, eggs, milk, fish, shrimp, and nuts. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included valsartan (DIOVAN), esomeprazole sodium (NEXIUM), acetylsalicylic acid (BABY ASPIRIN), alprazolam, atorvastatin (LIPITOR). The patient previously took codeine, morphine, clopidogrel (PLAVIX), isosorbide mononitrate (IMDUR) and experienced allergies. On 13Jan2021 15:00, approximately 1 hour after the shot, the patient experienced severe upper stomach pains and stomach pains all over and cramps. A few hours later, she got all over body pain, headache, nausea, and her ankles were swelling more the right one. These events are all still going on 3 days later. Treatment was not provided in response to the events. The patient has not undergone COVID testing post vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/13/2021,0.0,UNK,DIOVAN; NEXIUM [ESOMEPRAZOLE SODIUM]; BABY ASPIRIN; ALPRAZOLAM; LIPITOR [ATORVASTATIN],,Medical History/Concurrent Conditions: Acid reflux (oesophageal); Blood pressure high; Coronary artery disease; Egg allergy; Fibromyalgia; Fish allergy; Food allergy; Gastritis; Heart block AV second degree; Hypergammaglobulinemia; Milk allergy; Sulfonamide allergy,,,"['Abdominal pain', 'Abdominal pain upper', 'Headache', 'Joint swelling', 'Nausea', 'Pain']",1,PFIZER\BIONTECH, 990447,VA,21.0,F,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable Health Care Professional (patient). A 21-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL0142) at single dose, in the left arm, on 01Jan2021 at 09:00 PM, for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Relevant medical history was unknown. Concomitant medications included levocetirizine. On 12Jan2021, after receiving first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) the patient resulted positive to COVID-19. Post the vaccination, the patient has been tested for COVID-19 on 12Jan2021 and resulted positive. COVID-19 test type post vaccination: Nasal Swab (COVID-19 PCR test). No treatment received. Clinical outcome was unknown at time of this report.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/12/2021,11.0,PHM,LEVOCETIRIZINE,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990448,,,U,"tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable healthcare professional. A patient of unspecified age (age: 21; unit: unknown) and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that one of her colleagues tested positive for COVID after the first dose of the vaccine on an unspecified date. The outcome of the event was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990450,IN,33.0,F,"Miscarriage after 2nd vaccine.; Miscarriage after 2nd vaccine.; Miscarriage after 2nd vaccine.; Miscarriage after 2nd vaccine.; This is a spontaneous report from a contactable nurse reported for herself. This 33-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Es1686), via intramuscular at left arm on 11Jan2021 08:00 am at single dose for COVID-19 immunisation. Medical history was unknown. Concomitant medications were none. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685) intramuscular at left arm on 21Dec2020 10:15 AM for COVID-19 immunisation. The patient had no known allergies. The patient had no other vaccine in four weeks, no other medications in two weeks. The patient was pregnant. Last menstrual date was 14Dec2020. Delivery due date was 16Sep2021. Gestation period was 3 weeks. The patient experienced miscarriage on 16Jan2021 after 2nd vaccine. AE resulted in congenital anomaly or birth defect. The patient had no COVID prior vaccination. The patient had COVID tested/nasal swab post vaccination with negative results on 11Jan2021 and 13Jan2021. Outcome of the events was unknown.; Sender's Comments: Based on the available information, a causal relationship between event miscarriage after the second COVID-19 vaccination and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/16/2021,5.0,UNK,,,,,,"['Abortion spontaneous', 'Congenital anomaly', 'Exposure during pregnancy', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,OT 990454,TN,62.0,M,"headache, 10 hours later symptoms of fatigue and Bell's Palsy; headache, 10 hours later symptoms of fatigue and Bell's Palsy; headache, 10 hours later symptoms of fatigue and Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient receive first dose of bnt162b2 (lot number: EL3249, Pfizer), via an unspecified route of administration in right arm (shoulder) on 16Jan2021 06:30 at single dose for covid-19 immunization. Medical history included hypertension, gout, BP (blood pressure) abnormal, blood cholesterol abnormal all from an unknown date and unknown if ongoing. Concomitant medication included daily losartan for blood pressure, rosuvastatin calcium (CRESTOR) for cholesterol. The patient experienced headache, 10 hours later symptoms of fatigue and bell's palsy on 16Jan2021 16:00 about 10 hours after vaccination. Therapeutic measures were taken as a result of events. He was prescribed Prednisone 6 tabs PO (per oral) for 5 days, tapering down 1 tab daily. B12 Shot in 19Jan2021. He had an MRI (magnetic resonance imaging) appointment on 20Jan2021. His BP and cholesterol are both under control. Facility type vaccine: Hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. No additional vaccines administered on same date of the Pfizer suspect. The adverse event was not required a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Family Medical History included: Mother died of cancer in the early 90s. Dad died of heart failure in the early 80s. The outcome of events was not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/16/2021,0.0,PVT,LOSARTAN; CRESTOR,,Medical History/Concurrent Conditions: Blood cholesterol abnormal; Blood pressure abnormal; Gout; Hypertension,,,"['Facial paralysis', 'Fatigue', 'Headache']",1,PFIZER\BIONTECH, 990462,VA,31.0,F,"tested positive for COVID-19; tested positive for COVID-19; headache; This is a spontaneous report from a contactable nurse (patient herself). A 31-year-old female patient (not pregnant) received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid vaccine, lot EL1283), via an unspecified route of administration in the right arm on 21Dec2020 at SINGLE DOSE, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccines in four weeks. She had a sars-cov-2 test via nasal swab on 30Dec2020 and was negative. She was re-tested for sars-cov-2 and she was positive (via nasal swab) on 04Jan2021. The patient had her second dose of bnt162b2 on 15Jan2021. She informed that she had headache that started 30Dec2020 and during the 10 days following the positive test. She received the vaccine in a hospital and had doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of events was recovered.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 21Dec2020, and a repeated sars-cov-2 test via nasal swab positive on 04Jan2021. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/30/2020,9.0,PVT,,,,,,"['Headache', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990467,NY,50.0,M,"Stated that he received the first dose then took the test and it came out positive/got vaccinated 29Dec2020/took the Covid test on 30Dec2020/found out that he was positive on Friday (01Jan2021); Stated that he received the first dose then took the test and it came out positive/got vaccinated 29Dec2020/took the Covid test on 30Dec2020/found out that he was positive on Friday (01Jan2021); This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect, received from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 29Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he received the first dose then took the test and it came out positive. He was scheduled to take the second dose next Tuesday 19Jan2021 and wanted to confirm if he has to wait 90 days or still stick with the second dose since he has already had the first dose. Patient stated that he had got vaccinated on 29Dec2020. Stated that he took the Covid test on 30Dec2020 because someone tested positive and found out that he was positive on Friday (01Jan2021). He was cleared to return to work and he will tomorrow. He wanted to know if this will impede the vaccination process and wanted to know if he will have to redo the vaccination. Outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/30/2020,1.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990478,NJ,65.0,M,"Since getting first shot and again after the second shot, have had frequent afib/apc's; Since getting first shot and again after the second shot, have had frequent afib/apc's; This is a spontaneous report from a contactable Physician (ophthalmologist) reporting for himself. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: eh9899), intramuscular on 21Dec2020 at 15:00 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Patient age at time of vaccination was 65 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient was not receiving concomitant medications. Medical history included ongoing paroxysmal afib (atrial fibrillation). The patient has known allergies to squid. The patient reported having a long history of paroxysmal afib, very fit, play tennis at the national level. Prior to vaccine have had 2-3 brief bouts of afib/year. Since getting first shot and again after the second shot, have had frequent afib/apc's (atrial premature contractions) at least 6 episodes. Adverse event start date was reported as 21Dec2020 at 02:00 AM (pending clarification). No treatment was given for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The outcome of the event was unknown.; Sender's Comments: The event is considered possibly related to the suspect product based on the reportedly positive temporal association in a subject with a positive medical history of atrial arrhythmias. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/21/2020,0.0,PVT,,"Paroxysmal atrial fibrillation (paroxysmal afib, had 2-3 brief bouts of afib/year.); Seafood allergy (Allergy to squid)",,,,"['Atrial fibrillation', 'Condition aggravated', 'Supraventricular extrasystoles']",UNK,PFIZER\BIONTECH,OT 990490,WI,47.0,F,"my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across my chest; red splotchy rash; right side of my head was tingling; I was mildly tachycardic; This is a spontaneous report from a contactable other Health Professional (patient). A 47-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1284), via an unspecified route of administration on 06Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included allergies to adhesive and nickel. Patient did not have COVID prior vaccination. Patient did not have COVID tested post vaccination. There were no concomitant medications. It was reported that the day after vaccination, patient's right arm started to feel like it was on fire. This feeling quickly spread up neck and across chest and this area had a red splotchy rash. The right side of head was tingling. Patient took 50 mg diphenhydramine hydrochloride (BENADRYL) and headed to ER (Emergency Room) where patient received Dexamethasone. Patient was mildly tachycardic. Above events started on 07Jan2021 at 12:30. Outcome of the events was resolved.; Sender's Comments: The events are considered related to the suspect product based on the strong temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Adhesive tape allergy (Known allergies: adhesive),,,"['Burning sensation', 'Paraesthesia', 'Rash', 'Rash erythematous', 'Rash macular', 'Tachycardia']",1,PFIZER\BIONTECH, 990494,FL,77.0,F,"couldn't sleep; sudden hearing loss; complete hearing loss a few days later/hearing loss in right ear; constant humming in her right ear/getting hissing in my ear; arm felt tender; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was either: EL1283, CL1283, or LL1283) on 11Jan2021 at 11:00 at single dose in left arm for COVID-19 immunization. Medical history was none. There were no concomitant medications. Patient previously took pneumonia shot on an unknown date and flu shot in Oct2020 for immunization. Patient got the first dose of the vaccine on 11Jan2021 at 11:00 in the morning. On 11Jan2021 her arm felt tender where the needle went in.On 12Jan2021 late afternoon, she started getting hissing in her ear that was still there and had not gone away at all and she also had a constant humming in her right ear. By 13Jan2021, she still had the humming. She saw an ENT on 13Jan2021 and doctor didn't know if it was correlated to the vaccine or not; doctor took some wax out of her ear and she seemed to get relief from the hissing for about 15 minutes but about 15-20 minutes later the hissing/ humming continued. On 14Jan2021, woke up with complete deafness in right ear. Immediately called ENT doctor and did a hearing test. Patient could not hear and they confirmed she had sudden hearing loss in her right ear on 14Jan2021, she had nothing in her right ear (as reported). They put her on 40 mg a day of Prednisone (20mg tablets) and so far, prednisone hadn't done anything: originally taking prednisone 40mg for four days and was taking two a day; on 16Jan2021 when she was getting no relief and couldn't sleep due to the humming in her ear, she called doctor and was advised to take the 40mg together in the morning, she will take 40mg a day. On 19Jan2021 she took 20mg for four days and then decreased by half again. She was also advised by doctor to take 25mg Benadryl (UPC: 30048284 Lot: SPS023 Exp: Jun2022) at night. They are scheduling her for an MRI in Jan2021.Patient was also scheduled for the second dose on 01Feb2021 and will be on the prednisone until 26Jan2021; she would like to know whether the prednisone will diminish the effectiveness of the vaccine. She also asked if there was a certain amount of time she should wait to restart in case the doctor decided she should not get the second dose; she also wanted to know if she should wait on the second vaccine and maybe start over in two months.She was concerned and wanted to know if she should proceed with the second shot. The patient underwent blood work on an unspecified date to see if she can receive contrast for an MRI. She never had problem with MRI contrast before. Final outcome of the events was reported as unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/11/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Acoustic stimulation tests abnormal', 'Blood test', 'Cerumen removal', 'Deafness', 'Deafness unilateral', 'Injection site pain', 'Insomnia', 'Sudden hearing loss', 'Tinnitus']",1,PFIZER\BIONTECH, 990499,MO,49.0,F,"Sick; woke up 12 hours later and had a temp of 102 and arm pain/ temp gotten as high as 103 degrees Fahrenheit; arm pain; sweating; she was really tired; This is a spontaneous report from a contactable nurse. This 49-year-old female nurse reported for herself that she received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL8982) at single dose for Vaccination on 14Jan2021. The vaccine was injected to left deltoid/shoulder about 2:15 pm. Relevant medical history included ongoing uterine fibroids since Dec2019, ongoing obesity since Oct2000 and COVID-19 from Dec2020 to Dec2020. Relevant concomitant drug was unknown. The patient had surgical procedures when she had her first child. No Family Medical History Relevant to AE(s). Her mother got the shot a couple of days before caller did and she had no problems. The patient was administered her first dose of Pfizer BioNTech COVID-19 Vaccine on 14Jan2021. She reported that she became sick (Medically significant) about 12 hours later on 15Jan2021. The patient Went to sleep and woke up about 12 hours after she got the Pfizer-BioNTech COVID-19 Vaccine with a body temperature of 102 degrees Fahrenheit and arm pain. She could not really go back to sleep. When she got up it went away. She tried to go to work that day, and did go to work but she was really tired. When she finally got home she got in the bed and really had not been out of bed since then except for today she was sitting in a chair; so she thought maybe she had improved a little bit at on the reporting day. She had maintained a constant fever since 15Jan2021 that had gotten as high as 103 degrees Fahrenheit. At the reporting time her temp was 100.5. She had alternated Tylenol and Motrin for the fever. She was sweating profusely so it may be the temperature trying to break, but she had been struggling since she had it. This was so unlike her, she did not just stay in bed. She could not kick it. She had been unable to work since 15Jan2021 and she had to work tomorrow. She believed this was medically significant because she cannot work. The patient did not have vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No Additional Vaccines was administered on Same Date of the Pfizer Suspect. Relevant Tests was None. The patient did not visit the emergency Room nor Physician Office due to the events. The outcome of event being sick was resolving. The outcome of event temperature had gotten as high as 103 degrees Fahrenheit was not resolved. The outcome of other events was unknown. The patient thought the causality was yes 100% because her COVID-19 symptoms were not even this bad; she never had a fever with COVID-19; and she had never before had a fever this high for this long.; Sender's Comments: There is a plausible chronological association between vaccine administration and onset of the event; causality therefore cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/01/2021,,PUB,,Obesity; Uterine fibroids,Medical History/Concurrent Conditions: COVID-19,,,"['Fatigue', 'Hyperhidrosis', 'Hypersomnia', 'Impaired work ability', 'Malaise', 'Mobility decreased', 'Pain in extremity', 'Pyrexia', 'Sleep disorder']",1,PFIZER\BIONTECH, 990523,LA,80.0,M,"he is shrinking; chills; tired; cant walk; it hit me like I had the virus; it hit me like I had the virus; My eyes are hurting; no matter which way I turned it was hurting, knees, everything was hurting really bad/aches and pain; dizzy/dizziness; weak; muscle pain; joint pain/back knees elbow joint pain; fever; headaches; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received first dose of bnt162b2 (Pfizer BioNtech Covid 19 vaccine, lot number EL1283) , via an unspecified route of administration on 17Jan2021 01:15 at single dose for covid-19 immunisation. Medical history included open heart surgery 11 years ago, covid-19 from Jul2020 to an unknown date. The patient's concomitant medications were not reported. The patient received bnt162b2 yesterday, with no problems. However today (18Jan2021), in 15 minutes after waking up at 11, he had the chills really bad, that went away, then he went to sleep again and woke up and he had all the symptoms on the paperwork, he had dizziness, headache, he's hardly ever had a headache ever. He had aches and pain. Caller states that he was just asking right now about another company, and their vaccine in started with an M, and her daughter is at a girls home, because she has a epileptic type thing, and this particular shot, that started with M, the nurse called over, and the problems that he is having he explained to the nurse is like when he had the virus previously about in Jul2020, when he had the virus he was in hospital for a week, because he had to get rid of the virus, and they got him out of that. Now he took this shot yesterday and the next day is when he got all these symptoms, he's tired, cant walk, muscle pain, had chills not any more, pain in the knees, everywhere really, he couldn't get any position to go back to sleep, his back knees elbow joint pain. Since he had these things, the nurse at the girls home, told his wife if having these problems he can take 300 mg of Zinc, 1000mg of Vitamin C, and 2000IU or Vitamin D, the same thing, that amount, he asks will it over come the symptoms. Another person felt good after getting those, it helped him he does state however that is what the person took when he actually had the Covid 19 Virus. Caller states that he received paperwork after the vaccine from the (State), it has a bunch of blocks asking if he has this or that symptom. His First dose was 17Jan2021 at 1:15, then on 07Feb2021 if this Second Dose. All the side effects started Today 18Jan2021. His doctor said he's in good health. He did have open heart surgery 11 years ago. The patient reported he is 5 feet 8 and a half inches, he is shrinking. He stated, ""I was good until this morning, it hit me like I had the virus. The product they gave me at the (State) was the Pfizer-biontech vaccine. I had all the symptoms except vomiting/throwing up. I got all the other symptoms. no matter which way I turned it was hurting, knees, everything was hurting really bad. I was dizzy and weak so I don't want to walk around too much. I had muscle pain, joint pain, fever, headaches, chills, never went away. I hurt everywhere. I am really weak. My eyes are hurting. My daughter is in a girls home (paralysis problem). They had the vaccine from the another company and they have heard so many negative stuff so they decided they did not want to, when my wife told her I was having these problems. I had the virus 4 months, the nurse told me to take 300mg of zinc, 1000mg vitamin C and 2000mg vitamin D (the person took that when he had the disease). Should I take this stuff? Is there any information on that? what's in this? protein? my wife got the disease. They said she had enough antibodies. How long is the immunity? When does it start?"" The outcome of the event chills was resolved, of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/17/2021,01/18/2021,1.0,PVT,,,Medical History/Concurrent Conditions: COVID-19; Open heart surgery (11 years ago.),,,"['Arthralgia', 'Asthenia', 'Back pain', 'Body height decreased', 'Chills', 'Dizziness', 'Eye pain', 'Fatigue', 'Gait inability', 'Headache', 'Myalgia', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 990524,CT,,M,"Stroke like symptoms; This is a spontaneous report from a non-contactable consumer reporting for father in law. An elderly male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced stroke like symptoms in Jan2021 and was admitted to the hospital due to it. Outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,['Neurological symptom'],1,PFIZER\BIONTECH, 990525,,,F,caused a rib head to come out of socket; The vaccine caused a flair up of the arthritis in her shoulder; She still has pain in the shoulder now because it has pinched a nerve; She still has pain in the shoulder now because it has pinched a nerve; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in her arm on an unspecified date at a single dose for COVID-19 immunization. Medical history included arthritis in her shoulders bilaterally. Concomitant medications were not reported. The vaccine caused a flair up of the arthritis in her shoulder and caused a rib head to come out of socket. She still had pain in the shoulder now because it had pinched a nerve. Can she get the second dose in another site besides her deltoid? The outcome of events was unknown. Information about batch/lot number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Shoulder arthritis,,,"['Arthralgia', 'Arthritis', 'Condition aggravated', 'Joint dislocation', 'Nerve compression']",1,PFIZER\BIONTECH, 990531,,,M,"tested positive after his second Pfizer vaccine; tested positive after his second Pfizer vaccine; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (lot number and expiration date not provided) via an unspecified route of administration on an unspecified date at a single dose, and second dose (lot number and expiration date not provided) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive after his second Pfizer vaccine. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 990534,,,U,"Patient received 2 doses of vaccine and got COVID and was sick for 10-13 days with Covid; Patient received 2 doses of vaccine and got COVID and was sick for 10-13 days with Covid; This is a spontaneous report from a non-contactable Other-HCP (patient) via Pfizer Sales Representative. A patient of unknown age and gender received 2 doses of (PFIZER-BIONTECH COVID-19 VACCINE) on an unknow date at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. Patient received 2 doses of vaccine and she/ he got COVID and she/ he was sick for 10-13 days with Covid. The outcome of the events was unknown. No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['COVID-19'],2,PFIZER\BIONTECH, 990541,,,F,"Positive COVID-19 test; Positive COVID-19 test; This is a spontaneous report from a Pfizer sponsored program from a contactable physician. A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the first dose, was diagnosed for COVID-19. Clinical outcome was unknown at time of this report. The information on the lot number has been requested.; Sender's Comments: A possible contributory role of the suspect BNT162B2 cannot be excluded for the reported diagnosed for COVID-19. However, more information, such as Vaccine administration date, clinical course, underlying medical conditions is required for the Company to make a more meaningful causality assessments.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990543,MA,,F,"positive for Covid; positive for Covid; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient) from the Pfizer-sponsored program. A female patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine last 28Dec2020 and then last 04Jan2021, she was positive for COVID-19. She wanted to know if it is okay for her to take her second dose. The outcome of the events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990546,,,U,"patient tested positive for Covid after receiving the first dose; patient tested positive for Covid after receiving the first dose; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 7 patients. This report is for 5th of 7 patient. A patient of unspecified age and gender received the first dose of BNT162B2 (BNT162B2 also reported as Pfizer Covid vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer reported that 7 coworkers was tested positive for COVID after receiving first dose of the Pfizer Covid vaccine on an unspecified date. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045622 same drug/AE, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990547,,,U,"patient tested positive for Covid after receiving first dose; patient tested positive for Covid after receiving first dose; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 7 patients. This report is for the 7th of 7 patients. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number and expiry date were not reported, via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that patient tested positive for Covid after receiving first dose of the Pfizer Covid vaccine on an unspecified date. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045622 same reporter, drug and event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990552,IN,,F,"positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable female consumer (patient) of an unspecified age reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 15Jan2021, the patient tested positive for a COVID-19 test. The patient was put in isolation. She should receive her second dose on 19Jan2021, but she had to cancel her second shot since she was tested positive and she couldn't go. She called in because she wanted to reschedule her second shot of the vaccine. Local authorities can't give her second dose of vaccine until mid of February. She's trying to find out if it's okay. At the time of the report, the outcome of the events was unknown. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/15/2021,17.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990587,LA,71.0,F,"Not being able to eat; Not being able to drink; Not being to stand up; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 12Jan2021 14:50 at single dose in upper left arm for Prevent Covid. Medical history included ongoing rheumatoid arthritis from in 2008 (diagnosed about 12 years ago), ongoing fibromyalgia from in Nov2020 (diagnosed a couple of months ago), ongoing hypothyroidism diagnosed about 20 years ago. Concomitant medications included levothyroxine sodium (SYNTHROID) ongoing for Hypothyroidism, her dose has not changed for most of the years she has been on it; liothyronine sodium started taking from 2020 (about 6 weeks ago) after seeing an endocrinologist and ongoing for Hypothyroidism. The patient previously took Generic of Synthroid and it made her sick/ cannot take this was years ago; she got flu vaccine every year. Vaccination Facility Type was Rehab clinic associated with the Hospital in town. Vaccine Administered not at Military Facility. No Prior Vaccinations (within 4 weeks). She was calling about the first dose of Pfizer Covid vaccine. She was in the ER on Friday after having the vaccine. For 4 days she had not been able to eat, drink or stand up. She was pretty much only mildly better since Friday. She clarified that she received the vaccine on 12Jan2021 and the events started the same day within hours after receiving the vaccine. In the Emergency Room she received a bag of fluids. She had blood work and a chest x-ray done, she was told the chest x-ray was very good (12Jan2021). She was not told details about her blood work but she thought it was good since she was sent home. The only prescription that was given to her was for Zofran. She confirmed she was not admitted, she was in the ER for hours. She would be at her doctor's office this afternoon. She was slightly improved. She was resting right now to talk. She had been able to drink powerade and water. Last night after being force fed, she did eat a little it of supper, she did not enjoy it but she ate it. The events required a visit to Emergency Room. Reported she cannot take the generic of Synthroid called levothyroxine since it made her sick. This was years ago. She was grateful. She was nervous about taking the second dose. Advised to ask HCP when she saw her this afternoon. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,OTH,SYNTHROID; LIOTHYRONINE SODIUM,Fibromyalgia (diagnosed a couple of months ago); Hypothyroidism (diagnosed about 20 years ago); Rheumatoid arthritis (diagnosed about 12 years ago),,,,"['Blood test', 'Chest X-ray normal', 'Dysstasia', 'Feeding disorder']",1,PFIZER\BIONTECH,OT 990595,PA,61.0,F,"positive for covid; positive for covid; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program Pfizer First Connect. A 61-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm, intramuscular on 31Dec2020 at 0.25 mL, single for preventative. Time the Vaccination was Given between 7:30 to 08:00 am. Medical history was none. There were no concomitant medications. The patient took the first dose of the covid vaccine on 31Dec2020. She took a rapid test on Tuesday 12Jan2021 and found out she was positive for covid, she did not know the name of the test specifically. She stated she was lucky that she had mild covid symptoms. The outcome of event was unknown. No Follow Up attempts are Possible; Information on Lot/Batch Number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/12/2021,12.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 990619,AZ,,M,"he has been deaf since he got out; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. He has been a truck driver all his life. The patient reported that he has been deaf since he got out, on an unknown date. He stated that his heart doctor wanted him to take a nuclear test on 20Jan2021. Patient did not want to take a test if it will interfere with his shot and he wanted to know if this will interfere with his shot. The final outcome of the event was unknown. Information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,,,UNK,,,,,,['Deafness'],UNK,PFIZER\BIONTECH, 990627,PA,41.0,F,"Allergic reaction; Throat swelling; tightness; difficulty swallowing; This is a spontaneous report from a contactable Other Health Professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. The patient medical history reported no current heath issue like no ""acute"" (not clarified) current she got but she had got ""bulging"" (not clarified) disc and ""effects"" in the past, no ""aplasia"" (not clarified) nothing, no and she was ""marina"" (not clarified)."" There were no concomitant medications. The reporter reported a patient that had an allergic reaction to the Pfizer Covid vaccine. Nurse stated that when she was ""admitted"" (not clarified) she was in the ER being monitored she got ""admitted"" (not clarified) first day today 7:45 not clarified (15Jan2021). The patient experienced allergic reaction, included ""Throat swelling, tightness, difficulty swallowing."" The reporter gave the patient ""Api"" (not clarified) 0.3 milligram and then also she had ""Dimedrol"" (not clarified) 125 and then she had CAPCID 20mg IV ""piggy back"" (not clarified). She had Benadryl 50 milligrams."" The outcome of the events was unknown. Information on the batch number and lot number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of allergic reaction cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/15/2021,,,UNK,,,Medical History/Concurrent Conditions: Intervertebral disc disorder,,,"['Dysphagia', 'Hypersensitivity', 'Pharyngeal swelling', 'Throat tightness']",UNK,PFIZER\BIONTECH, 990634,,,U,"I am very ""hard of hearing""; My blood pressure went up, very high/high blood pressure/my BP was 186/113/my Blood pressure was like 214/87 to 205/99; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a shot on Wednesday (13Jan2021) and on Thursday (14Jan2021) morning, the patient's blood pressure went up, very high. The patient had high blood pressure. That is when the patient took blood pressure tablets (unspecified medication). The patient's BP was 186/113 and pulse was 62. The patient was taking BP (measurement or medication?) all the time. Anyways, the patient was just wondering yesterday (15Jan2021), the patient's blood pressure was like 214/87 to 205/99 which was really high, and the patient went to the emergency care, they gave the patient some pills to bring it down anyways. The patient was just wondering because it just could be coincident. From the patient's sheets, it looked like the patient's blood pressure was going up a little bit. The patient wanted to see if it's some sort of reaction or (incomplete sentence). The patient also stated very ""hard of hearing (further not clarified)"". The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/14/2021,1.0,UNK,,,,,,"['Condition aggravated', 'Hypertension', 'Hypoacusis']",UNK,PFIZER\BIONTECH, 990641,,,F,"Went to go get a Covid test and it came back positive; Went to go get a Covid test and it came back positive; had a bitter taste in her mouth; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse(patient) reported that a female patient of an unspecified age received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunization. The patient medical history was none. The concomitant medications were none. The patient got the vaccine on the 02Jan2021. After getting the vaccine she started losing taste. After getting vaccine in Jan2021 she had a bitter taste in her mouth. She went to go get a Covid test and it came back positive in Jan2021 and she had additional questions. The patient stated it was the Pfizer vaccine but she did not think it gave her the Covid because she had symptoms before that period then they just came back. If it feels with adverse reaction or anything just wanted to know if it was associated with the vaccine or not.The patient stated she did not lose taste, she just had a bitter taste. She could taste everything. She just had bitter taste in her mouth. She did not think bitter taste in her mouth was related to product. The patient just find anybody who can explain to her if it was okay for her to go for the second dose because there was no more information about the Pfizer because she had Covid. She just needed to know it was ok for her to get the second dose or stop the vaccine. The patient was informed to contact Medical information. The outcome of the events was unknown. Information on the batch number/lot number has been requested.; Sender's Comments: Based on the available information and time association, the possible contribution of suspect BNT162B2 administration to the COVID-19 infection and bitter teste cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'Dysgeusia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 990649,NJ,51.0,F,"She got the vaccine and now she has Covid, she is tested positive; She got the vaccine and now she has Covid, she is tested positive; This is a spontaneous report from a contactable nurse (patient's husband). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142, expiry date not reported) on 07Jan2021 intramuscularly in left deltoid muscle at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID), amlodipine besilate/ atorvastatin calcium (CADUET). The patient received the vaccine and then had COVID. On 07Jan2021 Thursday, the patient received the vaccine, and on Tuesday (12Jan2021) she said she was not feeling good. On Thursday (14Jan2021) she went to work and because she was not feeling good, she was tested and she was tested positive. The patient worked in a nursing home where she had been tested almost everyday. She was tested negative before she got the vaccine. She was at home, not receiving treatment for COVID. The reporter didn't understand why the patient (reporter's wife) got the vaccine and then had COVID. The outcome of the event was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event tested positive based on the known safety profile. However the short duration of 7 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/14/2021,7.0,UNK,SYNTHROID; CADUET,,,,,"['COVID-19', 'Feeling abnormal', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,OT 990653,FL,,M,"Gas; Aches and pains; Passed out; Fell; did get hurt when he fell; Hit his head on the counter and cut open his head; Dizzy; Nausea; Weakness/He is very weak; This is a spontaneous report from a contactable consumer (caregiver). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 as a single dose for COVID-19 immunisation, lot number: unknown. Medical history included Blood pressure high. Concomitant medications included some blood pressure medicine (no names reported). It was reported that patient got up in the morning the following day (on 16Jan2021), so dizzy, weak, nauseous, and he fell (did get hurt when he fell), passed out. On the way down, he hit his head on the counter and cut open his head, not a pretty sight when he got up. On unknown date patient experienced gas, aches and pains. Patient was very weak. Patient was not going to pass out, but he was very weak, and reporter thought some of it was from fall, he fell. When you pass out, you fall like a ton of bricks. He fell on a tile floor. So, he had gas, he had some aches and pains now too. Patient was going to take him to the doctor because he did get hurt when he fell. No treatment received for the events, patient had not seen a doctor yet, he will be seeing one the day of the report. Patient had not recovered from weakness, while outcome of the other reported events was unknown. Information about Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/16/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Asthenia', 'Dizziness', 'Fall', 'Flatulence', 'Head injury', 'Loss of consciousness', 'Nausea', 'Pain', 'Skin laceration']",UNK,PFIZER\BIONTECH, 990669,,63.0,F,After 7 days left arm shot area is pink and itches a lot,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/29/2021,7.0,MIL,,None,kidney removed two years ago followed by anemia and diberticulosis,,MiicardisPlus 40/12.5 mg Fumarate de bisoprolo 1 mg,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 990670,,30.0,F,"Pt received first dose of COVID-19 vaccination on 7 Jan 2021. She reports 8 days after receiving the vaccine she woke up with her left arm (vaccine arm) feeling like ""deadweight"". The vaccine sight was warm to the touch, swollen, and an erythematous, raised, pruritic rash was present. The rash stayed localized, did not spread. Interventions include ice, Tylenol, and Motrin with no relief. Pt reported resolution of above symptoms 72 hours after they presented. She reports some lingering fatigue and a swollen lymph node in axillary chain n the arm pit of the arm she recieved the vaccine. She denies drainage/discharge from site, pain in area, or overlying pore/punctum. She denies angioedema or anaphylaxis reaction to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/15/2021,8.0,MIL,"Cymbalta, Singulair, Claritin",No,Migraine Headaches Anxiety,,Ascorbic Acid,"['Fatigue', 'Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Lymphadenitis']",1,MODERNA,IM 990671,NY,53.0,F,"Two day after vaccine I had a pain on my left side, left chest under or near left breast. It was a constant pain or discomfort. It lasted from Friday-Monday . I was concerned that maybe was a blot clot ( I have two clotting disorders) I did know about this site until today. It was not explained to me at the Vaccine clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/08/2021,2.0,PVT,"Xarelto, Gabapentin, Fluoxetine",,"Factor V Liden, Hyperprothrominemia",,,['Chest pain'],1,MODERNA,SYR 990672,IL,35.0,F,"At 11:30am the next day after receiving the second dose, I became extremely fatigued and felt dizzy and very nauseous. On the morning of 1/31/21, I felt the exact same symptoms but this time the nausea led to vomiting.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/23/2021,1.0,PHM,,,,,,"['Dizziness', 'Fatigue', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 990673,WA,55.0,F,"One day after second dose of moderna , had bad chills, body aches, joint pain, sore throat, headache, fever. Lasted 2 days. Took repeated doses of excedrin migraine, Advil, and liquid cold medicine. Two days after vaccine, developed patchy, slightly raised, itchy red rash extending approximately 5 inches below the injection site. No rash on rest of body. Rash still visible 4 days after injection but not as severe.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/28/2021,1.0,WRK,"Multivitamin, glucosamine chondroitin with MSM, venlafaxine 37.5 mg, 1/2 tsp tumeric",2nd shingles vaccine on 1/7/2021,No,,No,"['Arthralgia', 'Chills', 'Headache', 'Injection site pruritus', 'Injection site rash', 'Oropharyngeal pain', 'Pyrexia']",2,MODERNA,IM 990674,KY,40.0,M,"Fatigue, muscle aches, fever, chills, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/29/2021,1.0,SEN,,,,,,"['Chills', 'Fatigue', 'Malaise', 'Myalgia', 'Pyrexia']",2,MODERNA,IM 990675,,39.0,F,"Metaletic taste, chills, rash, fatigue, muscle pain and weakness, severe nausea and vomitting. Vomitted for 3 hrs. Vomitting occurred 48 hr after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,MIL,"Vitamin D, Vitamin B12, Iron, omperazole, sertraline,",None,"Asthma, chronic Sinusitis,",,"Dairy, Casin, gluten","['Asthenia', 'Chills', 'Dysgeusia', 'Fatigue', 'Myalgia', 'Nausea', 'Rash', 'Vomiting']",2,MODERNA,IM 990676,FL,89.0,F,Client stated shortness of breath. Paramedics assessed client and client was transported to Hospital.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/30/2021,01/30/2021,0.0,PUB,Client unsure of medication currently taking,,,,,['Dyspnoea'],2,PFIZER\BIONTECH,IM 990677,MA,85.0,M,"itchy rash in b/l arms. itch resolved after 3 hours, and skin became scaly and peeling in tiny patches about 0.5 cm, multiple, across b/l arms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PUB,"FINASTERIDE 5 MG TABLET Instructions: TAKE 1 TABLET BY MOUTH once a week NICOTINAMIDE POWDER (NIACINAMIDE) Instructions: 250-500mg daily PROGESTERONE ER 25MG CAP Instructions: 1 by mouth one time daily every M,W,F DHEA 50 MG ORAL CAPSUL",,"AORTIC INSUFFICIENCY, MILD; ECHO 9/20 LONG-TERM (CURRENT) USE OF ANTICOAGULANTS AORTIC ARCH DILATION 4.3 CM ON CTA 10/19; 4.1 CM 9/20 ECHO PULMONARY HYPERTENSION-MOD ECHO 9/19; FELT TO BE LEFT HEART HX (CAD, AFIB) HYPERHOMOCYSTEINEMIA HYPONATREMIA CATARACTS-S/P B/L REPLACEMENT MENISCUS DEGENERATION-S/P B/L KNEE SURGERY OSTEOPENIA KIDNEY CYST, ACQUIRED; LEFT, EXOPHYTIC, 2 CM; ABD CT 5/16; DX SIMPLE CYST ON US 5/17; STABLE 5/18 SMALL BOWEL OBSTRUCTION-RECURRENT ATRIAL FIBRILLATION, PAROXYSMAL TIA-APHASIA, PROBABLY TOXIC/METABOLIC S/P REMOVAL OF APPENDIX-CRITCHLOW ? of LYME DISEASE (EARLY, LOCAL) DISC DISEASE, LUMBAR SCOLIOSIS, IDIOPATHIC S/P L4-L5 HEMILAMINECTOMY SCIATICA- L5-S1 DISC BULDGE PERIPHERAL NEUROPATHY, B/L TOES HX OF ELEVATED HEAVY METALS; S/P CHELATION TX ELEVATED C-REACTIVE PROTEIN HYPOTHYROIDISM DYSLIPIDEMIA TESTOSTERONE DEFICIENCY IRON DEFICIENCY HEMORRHOIDS, EXTERNAL PLANTAR FASCIITIS FRACTURE, FINGER-LEFT 3RD NEVUS, ATYPICAL GASTROESOPHAGEAL REFLUX-GE JUNCT EROSIONS, EGD 11/10 BENIGN PROSTATIC HYPERTROPHY, W/O OBSTRUCTION ROTATOR CUFF SYNDROME HEMATOSPERMIA PROSTATITIS, ACUTE ARTERIOSCLEROTIC HEART DISEASE-CTA SHOWING <50% IN 3 VESSELS BASAL CELL CANCER-S/P MOHS TO LEFT NASAL BENIGN NEOPLASM OF TONGUE-PRECANCEROUS TINNITUS LEIOMYOMA STOMACH GOUT, ACUTE S/P EXC HYDROCELE UNI-RIGHT S/P VASECTOMY COLON POLYP PES PLANUS",,"Lipitor, cipro, bactrim","['Pruritus', 'Rash', 'Skin exfoliation']",1,PFIZER\BIONTECH,IM 990678,CA,56.0,F,"Injection site bruise(bleed a lot at injection ) Itchy, red, swollen(harden) right below the injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/23/2021,01/31/2021,8.0,OTH,"VitaminD, turmeric, astaxanthin, probiotics",NONE,NONE,,NKA,"['Injection site bruising', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA, 990679,MD,56.0,F,dizziness immediately after injection; Repeated headaches ever since,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,Effexor Ropinerole Trazadone,None,Smoker,,Sulphate Amoxicillin Cephalexin Augmentin,"['Dizziness', 'Headache']",UNK,MODERNA,IM 990680,CT,27.0,F,"Erythematous rash and urticaria that started on anterior neck and spread to eyes, cheeks, forehead, ears. Rash lasted about a week.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/27/2021,5.0,UNK,Lo lo estrin,N/a,N/a,,Nickel,"['Rash erythematous', 'Urticaria']",2,MODERNA, 990681,FL,35.0,F,"Chills (no fever), myalgia, arthralgia, fatigue, malaise, headache, right arm soreness. No treatment given except rest. Lasted ~24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,OTH,,None,None,,Compazine,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Limb discomfort', 'Malaise', 'Myalgia']",2,PFIZER\BIONTECH,IM 990683,FL,71.0,F,"Client stated, ""I feel very sleepy."" Spouse reported hat client was lightheaded and dizzy. Fire Rescue attended to client on site. Released home with her spouse awake, alert and verbally responsive.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/30/2021,01/30/2021,0.0,UNK,,,,,,"['Dizziness', 'Somnolence']",2,PFIZER\BIONTECH,IM 990685,CT,68.0,F,Awoke in the night with fever. Fever persisted for about 30 hours. Temp taken at 102.9. Felt weak for days afterward.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/28/2021,01/29/2021,1.0,PUB,"famotidine 10 mg bid, lipitor 5mg qday, maxzide 1/2 tab qday, vitamin D, vitamin B, milk of magnesium,",none,hydronephrosis,,"NSAIDS, Prevacid","['Asthenia', 'Pyrexia']",2,MODERNA,IM 990686,FL,79.0,F,"Client reported warm feeling to face and neck, lightheadedness 3 minutes after receiving the vaccine Care initiated by facility. Vital signs within normal range. Client declined further treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/30/2021,01/30/2021,0.0,UNK,,,,,Sulfa,"['Dizziness', 'Feeling hot']",1,PFIZER\BIONTECH,IM 990687,NC,38.0,F,Rash with soreness at injection site and going down right arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,PUB,"Tylenol, Benadryl, and Propranolol",None,High blood pressure,,"Latex, penicillin","['Injection site pain', 'Injection site rash']",2,MODERNA,SYR 990688,FL,39.0,F,Supraclavicular lymphadenopathy,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/11/2021,5.0,PVT,Levothyroxine,None,Hypothyroidism,,None,"['Lymphadenopathy', 'Ultrasound scan abnormal']",1,MODERNA,IM 990689,FL,83.0,F,"Client's son reports that client complained of throat tightness, new onset coughing. Client was treated on site by Fore Rescue and transported to Hospital by ambulance.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/30/2021,01/30/2021,0.0,UNK,,,,,,"['Cough', 'Throat tightness']",1,PFIZER\BIONTECH,IM 990690,IN,26.0,F,"Patient here for COVID vaccine. Patient's left deltoid muscle was punctured with needle. After puncture I noted that the syringe was empty, there was nothing in syringle. Site Coordinator, was notified and situation was explained to patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,PVT,,,,,,['Product administration error'],UNK,MODERNA, 990691,PA,71.0,M,nausea - couldn't hold down water or food for first day abdominal pain back ache blood in urine on third day after shot still in pain...haven't slept last two nights,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/30/2021,1.0,WRK,None,none,hemochromatosis - under control Prostatectomy June 2019 iguinal hernia,,maybe penicillin,"['Abdominal pain', 'Back pain', 'Blood urine present', 'Nausea', 'Sleep disorder', 'Vomiting']",1,MODERNA,IM 990692,OK,69.0,F,"Very sore at injection site and had a small round red spot. 4-5 days later it started itching , very tender, very red & very hot to touch. 2 days later the spot was getting bigger. As of this minute it is not as red, but hot and has a bit of a streak down from the injection site. It is about 2 1/2"" tall & 2 1/4"" wide.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/26/2021,4.0,OTH,"Paroxatine, Levothyroxine, Propranolol, simvastatin & ezetimine, Lyrica, 1 baby asprin, Plavix. Vitamin C500 ms 1 daily, Vitamin A2400 mcg dailoy, CoQ10 200 mg daily. Calcium 600 bid, vitamin D 3 2000 IU dail6y. Xanax 1-2 times da",Fibromyalgia. Just getting over a flare up. Bones & joints already hurt before Modernas shot.,"Fibromyalgia, mid high cholesterol. anxiety","Pneumonia Booster very swollen, red and extremely painful for 3-4 weeks.","all gluten, all lactose Most antibiotics make me itch and feel like death warmed over.","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 990693,MN,34.0,F,"Rash on forearms 1 hour following injection that disappeared within 12 hours. Vulvar irritation including lesions noticed roughly 36 hours post injection, lasting for 2 weeks. No interventions or medications used for treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/15/2021,2.0,PVT,None,None,None,,"Doxycycline, Amoxicillin, bees","['Rash', 'Vulvovaginal discomfort']",2,PFIZER\BIONTECH,IM 990694,MI,52.0,F,"39 hours after I received 2nd injection, started with bad migraine (3x as bad as usual migraine), diarrhea, nausea, had temp of 99.5F for one day, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/30/2021,2.0,PVT,"Diamox, corgard, carafate, klonopin",Gastritis,Migraine,,Emyacin and amoxicillin,"['Diarrhoea', 'Fatigue', 'Migraine', 'Nausea']",2,PFIZER\BIONTECH,IM 990695,OK,67.0,M,"Extreme fatigue, body ache, fever (101.1) night of the injection and all the next day. I also had a rash develop on the wrist of the arm where I was injected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,OTH,None,None,Type 2 diabetes Pacemaker,,Iodine for CAT scan only,"['Fatigue', 'Pain', 'Pyrexia', 'Rash']",UNK,MODERNA, 990696,FL,34.0,F,"Myalgias, Rigors, Syncope, Hypoglycemia, Nausea, Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,PVT,none,none,none,,none,"['Chills', 'Hypoglycaemia', 'Myalgia', 'Nausea', 'Syncope']",2,MODERNA,IM 990697,MO,62.0,F,"chills, aching, headache, slightly nauseous, low grade fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,OTH,"Vitamin C, Calcium w/D3, Valsartin HTCZ 125 mg, Aspirin 325, Celebrex 200 mg, Claritan 10 mg, Omeprazole 10 mg (2� daily), Benedryl (2 tablets daily), Atorvistatin 10 mg, Metoprolol succinate 25 MG",None,Obesity,,none,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 990698,TX,57.0,F,?Moderna COVID-19 Vaccine EUA?,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,OTH,"Levothyroxine, Buspiron, Sertraline, Dexilant, Lunesta, Imitrex, Aleve, Tylenol Magnesium, CoQ10, Tumeric, Colace, Iron, Vitamin D",None,"Hypothyroidism, migraines",,SimVastatin (Lipitor) latex Sulfa Drugs,['COVID-19 immunisation'],2,MODERNA,IM 990699,IN,71.0,F,"On Jan 31, had a scratchy feeling on L back, under the bra area and on L arm (upper, back). It was irritating, itchy and slightly painful. During the night, the same symptoms. A little more painful today, also noted red marks on the back area and arm. Appears to be Shingles. Also yesterday I had a slight discomfort in my Left chest. That remains today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/31/2021,3.0,OTH,"Pantrapozole, atenolol, xyzal, plaquenil, folic acid, singulair, restasis, hydroxycycline, presnisolone acetate-1% Suspension, methotrexate, atorvstatin, prednisone, symponi infusion q 2 months (due Feb. 4th), folic acid, magnasium, vit. D.",None,"Rheumatoid Arthritis, Sjogrens syndrome, IBS, Tachycardia, Osteoarthritis,",,NKA,"['Chest discomfort', 'Erythema', 'Pain', 'Pruritus', 'Scratch', 'Skin irritation']",UNK,MODERNA,IM 990700,VA,39.0,F,"Progressive body numbness and tingling from chest down, unable to feel when urinating or have a bowel movement, tight girdle banding feeling on and around chest and back, hand malfunction with drawing, unable to walk without cane/walker, feeling of walking on a bounce house as walking",Not Reported,,Not Reported,Yes,5.0,Yes,N,01/21/2021,01/22/2021,1.0,SEN,Synthroid Wellbutrin Lexapro Meloxicam Vitamin D,UTI,Asthma Hypothyroidism Anxiety,,None,"['Band sensation', 'Blood glucose abnormal', 'Blood test', 'Bowel movement irregularity', 'Computerised tomogram', 'Dysgraphia', 'Dysuria', 'Gait disturbance', 'Hypoaesthesia', 'Laboratory test', 'Lumbar puncture', 'Magnetic resonance imaging', 'Myelitis transverse', 'Neurological examination', 'Paraesthesia', 'Walking aid user', 'X-ray']",UNK,UNKNOWN MANUFACTURER, 990701,FL,71.0,F,Rash appeared on arm at site of shot - 9 days after administration,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/30/2021,9.0,PHM,"Levothyroxin, metformin,trianterene, rosouvastatin, fis oil, zinc, vitamin d, magnesium, vitamin c, turmeric, methenamine, nac,",Allergies,"Hypertension, hyperlipidemia",,None,['Injection site rash'],1,MODERNA,SYR 990702,NJ,50.0,F,"My 2nd dose was given 1/18/2021. On 1/21/2021 at 2:00 am, my temp was 100.9 ( oral ). I started taking Tylenol and did not go to work. An hour before Tylenol is due, I start feeling the chills and then fever. If I skip Tylenol or Advil, my fever starts. I was cleared to go back to work today but yesterday 1/31/2021: took Tylenol close to 9 am and by 4:05 my temp is 102.6. Still not back to work.. My highest temp was 1/25/2021: 10:50 am: 104.3. I?ve been having fevers and at times chills for 11 days since the 2nd vaccine dose and still having fevers today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/21/2021,24.0,PVT,"I did not take my supplements: Vit. D, Fish Oil, Turmeric, Coconut Oil, Baby Aspirin, Biotin, Vit. C, Vit. E and Garlic.",None.,None.,My first flu vaccine: year 1999. I got sick. Age: 29 y/o. Forgot the rest of the information.,None.,"['Chills', 'Impaired work ability', 'Pyrexia', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 990703,IL,43.0,F,Developing an unusual sense of smell of metal mixed with formaldehyde and vinegar since yesterday. Smell is intermittent and lasts for about 5-10 seconds.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/31/2021,18.0,OTH,Propranolol 20mg Omeprazole 20mg,None,None just started propranolol (headaches and slight blood pressure increase) and omeprazole (possible acid reflux) in November 2020.,,Contrast dye Amoxicillin Lactose intolerance,['Parosmia'],1,MODERNA,IM 990704,VA,67.0,M,"Rash, blistering, In scalp, neckline, back of neck, burning sensation, right side and back of head. Painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/28/2021,6.0,PUB,"Metformin,Rousvastatin, Amlodipine Omeprazole","A1C, Rieters Syndrome",Uncertain,,"Penicillin, Latex, Kiwi, Ratanadine, Gluten.","['Blister', 'Burning sensation', 'Flank pain', 'Headache', 'Rash']",1,MODERNA,SYR 990705,NJ,60.0,M,"Severe myalgias, fever, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/30/2021,0.0,PHM,None,None,None,,No known drug allergies,"['Fatigue', 'Myalgia', 'Pyrexia']",2,MODERNA,IM 990706,NY,82.0,F,"Complain of itching, no observations of rash or hives. Medical director present, administered one dose of Benadryl 25 mg tab, patient state a history of itching after vaccinations. Patient was monitored for 30 minutes, rode home with her husband.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/29/2021,01/29/2021,0.0,PUB,,,,,,"['Pruritus', 'Reaction to previous exposure to any vaccine']",1,MODERNA,IM 990707,TX,64.0,F,"Fever up to 101.8 before taking Tylenol at 2:30 pm on January 30, 2021. Fever started at 6:30 am that morning. Intense fatigue and moderate headache. I had joint and body aches. I experienced lightheadedness when I got up when fever was 101.8 at 2:30 pm. I had to lay down again and apply a wet towel. Once I felt able to walk (about 10 minutes later) I ate a popsicle and then proceeded to take two 325 mg of Tylenol. Within 30 to 45 minutes fever subsided. I then ate soup, crackers and an orange and drank cranapple juice. I went back to bed and slept some more. I woke up at 5 pm and had a cup of soup, a quarter of an apple and gatorade. At 9 pm I took two more Tylenol to be safe and when to sleep. Sunday I was fine. My arm, never was swollen only a little sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,PVT,None,None,Pre-hypertension,,Sulfur,"['Arthralgia', 'Dizziness', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 990708,MI,31.0,F,"About 24 hours after receiving the vaccine, I developed a headache at the base of my skull and some mild joint pain in my left hand. The joint pain lasted <1 day, the headache lasted ~1.5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,birth control pill,none,none,,none,"['Arthralgia', 'Headache']",1,PFIZER\BIONTECH,IM 990710,MA,30.0,M,Headache and chills,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/20/2021,0.0,UNK,"Ibuprofen 800 mg tablet, FLUoxetine",,,,None,"['Chills', 'Headache']",1,MODERNA,IM 990711,OH,45.0,F,"Chills, low-grade fever, body aches, extreme fatigue, loss of apetite",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,PVT,None,None,None,,Penicillin,"['Chills', 'Decreased appetite', 'Fatigue', 'Pain', 'Pyrexia']",2,MODERNA,IM 990712,MO,48.0,F,"The evening of 1/29/21, hives (small red itchy bumps) started on the side of my right knee and then spread to upper thigh. The morning of 1/31/21 the hives had spread to my right forearm and left thigh. The morning of 2/1/21 the complete front side on my right leg and shin are covered in hives. The hives are gone from my forearm and only a few remain on my left thigh. I have taken benedryl over the counter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/30/2021,2.0,PUB,multi vitamin,none,none,,none,"['Rash', 'Rash erythematous', 'Rash pruritic', 'Urticaria']",1,MODERNA,SYR 990713,OH,76.0,M,I am not sure if this is a reaction but 3 weeks after the first vaccination I developed painful spots in my fingers that now have continued for 10 days and some new have developed and the old ones have changed it seems to me as a vasculitis of some kind I will see my PCP on 2/19/21 but for now I am going to skip the second dosage,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/16/2021,10.0,OTH,"metoprolol, lisinopril, colchicine , omeprazole ,",none,"HTN , gout ,",,none,"['Pain in extremity', 'Vasculitis']",1,MODERNA,IM 990714,MI,65.0,F,Nausea. Vomiting. Joint swelling muscle Couldn?t walk day 2. Skin hurts. Spine hurts. Neck can?t band or turn.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,PVT,"Armor Thyroid, Creon 36000",None,Malabsorption. Due to whipped operation,Flu,Sulfa. Amoxicillin. Stimulants.,"['Gait disturbance', 'Joint swelling', 'Mobility decreased', 'Muscle swelling', 'Nausea', 'Pain of skin', 'Spinal pain', 'Vomiting']",1,MODERNA,SYR 990715,GA,39.0,F,"Flushing, all over sensation of pins and needles, dizziness/shakiness, heart rate increased. Lasted for about 8 mins. Stayed in pharmacy for 20 mins, drank water. No more symptoms returned.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/30/2021,0.0,PHM,Escitalopram (20mg),Preliminary diagnosis of POTS,None,,None,"['Dizziness', 'Flushing', 'Heart rate increased', 'Paraesthesia', 'Tremor']",1,MODERNA,SYR 990716,MI,31.0,F,"About 14 hours after receiving the vaccine, I developed chills and felt feverish (do not own a thermometer so was unable to check temp). Throughout the night, I had chills and moderate muscle/joint pain. The following day, I had chills, muscle aches, joint pain, and a headache. I took some Tylenol and the symptoms lessened significantly. The following day (48 hrs after receiving the vaccine), I felt completely back to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PVT,birth control pill,none,none,,none,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 990717,OH,27.0,M,"Body aches, shaking, headache, dizziness, chills, sleeplessness",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/26/2021,01/27/2021,1.0,PVT,,,,,,"['Chills', 'Dizziness', 'Headache', 'Insomnia', 'Pain', 'Tremor']",2,MODERNA,IM 990718,GA,51.0,F,"1st shot on 1/5/2021 felt really tired and fatigued. Woke up at 5:30am on 1/6/2021 with chills and a headache. Some light swelling and soreness at the injection site on the left arm. 2nd shot on 1/26/21 @ 4:15pm. Right arm swollen, muscle very sore and tight feeling. Some bruising. Half dollar sized knot at the inject site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,WRK,"Metformin, Reglan, Pantoprazole, Jardiance, Losartan, Actos, Goli, One a Day vitamin for women. Flonase as needed. Benadryl as needed.",None,Diabetes High Blood Pressure,,Allergies to fresh peaches.,"['Chills', 'Contusion', 'Fatigue', 'Headache', 'Injection site nodule', 'Injection site swelling', 'Muscle tightness', 'Myalgia', 'Peripheral swelling']",2,PFIZER\BIONTECH,SYR 990719,VA,64.0,F,"approx 13 hours after vaccine developed chills, fatigue, anorexia. Lasted approximately 12 hours Also injection site was hard, swollen, red and warm; lasted 4 days, and even at 1 week still tender if palpated",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,PVT,"lisinopril, metoprolol, crestor,amlodipine, prilosec, magnesium, calcuium, tumeric, Tylenol take prior to and during first 24 hours after vaccine",none,"HTN, high cholestrol",as reported previously - no adverse response to first dose,"INH, reglan, sulfa","['Chills', 'Decreased appetite', 'Fatigue', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",2,MODERNA, 990720,WA,57.0,F,"Same day injection site pain. Next day had flu-like sx's, which resolved. This AM developed erythema, induration, pruritus, warmth just below injection site. No acute SOB.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/12/2021,0.0,PHM,ibuprofen,COPD flare,,,"trazodone, spironolactone, penicillins, aspartame","['Influenza like illness', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",UNK,MODERNA,IM 990721,GA,38.0,F,The 1st dose of COVID-19 vaccine (Moderna) was administered on 1/12/2021. The 2nd dose was administered inadvertently too soon.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/27/2021,01/27/2021,0.0,PUB,,,,,,['Inappropriate schedule of product administration'],2,MODERNA,IM 990757,LA,90.0,F,"following administration, pt had progressive diarrhea, hypoglycemia not responsive to eating/drinking requiring hospitalization (glucose as low as 31 - short D5W drip); workup for infection, thyroid, or adrenal cause all negative",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/16/2021,01/21/2021,5.0,PVT,tylenol/imodium,,"type 2 diabetes - controlled on metformin alone, hypertension, Paroxysmal atrial fibrillation, Hyperlipidemia, hypothyroidism, history of left breast cancer",,Avelox/Levaquin,"['Blood culture negative', 'Blood glucose decreased', 'Cortisol normal', 'Culture urine negative', 'Diarrhoea', 'Diet refusal', 'Hypoglycaemia', 'Thyroid function test normal']",1,PFIZER\BIONTECH,IM 990776,PA,85.0,M,"The next day he had facial swelling and burning on right side of face. 2 days after he had a high fever and flu symptoms. 3 days later he became unable to move legs to walk, had severe double vision and lost hearing in right ear,in ED at hospital then admitted on day 4. Broke out in shingles like rash but had no pain as you normally would with shingles. In hospital 10 days, still can't walk without assistance after 5 months.",Not Reported,,Not Reported,Yes,10.0,Yes,N,10/01/2020,10/01/2020,0.0,PVT,"Zytiga, prednisone, tamsulosin",None,Prostate cancer,,None,"['Blood test', 'Burning sensation', 'Chest X-ray', 'Computerised tomogram head', 'Deafness unilateral', 'Diplopia', 'Gait disturbance', 'Herpes zoster', 'Influenza', 'Laboratory test', 'Mobility decreased', 'Pyrexia', 'Rash', 'Swelling face']",1,SANOFI PASTEUR,IM 990780,MI,75.0,M,patient passed,Yes,01/28/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/28/2021,3.0,SEN,,Marko Cell Carcinoma Matasisized,was in hospice since 8/11/20 had cancer,,,['Death'],1,MODERNA,IM 990792,IL,71.0,M,"Bell's palsy -L side of face began 1/30/2021. Gradual onset. Began with dysarthria and droop of corner of mouth, then upper brow of eye, then weakness in closing L eye. Went to Hospital ER. Diagnosis made after exam and tests",Not Reported,,Not Reported,Not Reported,,Yes,N,01/20/2021,01/30/2021,10.0,PHM,Remicade infusions q. 6 wks. Multi. vits/da Methotrexate 12.5mg/ wk Tamsulosin 0.4mg/da Citracal Vit. D 2000mg/da Omeprazole 20mg /da,None,Crohn's disease Psoriasis,,None,"['Computerised tomogram', 'Dysarthria', 'Extraocular muscle paresis', 'Facial paralysis', 'Full blood count', 'Magnetic resonance imaging', 'Metabolic function test']",1,MODERNA,IM 990911,VA,25.0,F,"Got shot at church at 11:00 AM, had adverse effects immediately after sitting down. Started off being disoriented and light headed which led to me losing consciousness. Would go in and out of consciousness until sternum checked multiple times. Got picked up by the ambulance and taken to the hospital as blood pressure was low and was fevering per first responder. Had an ekg with tachycardia, once delivered to the hospital. Still in and out of consciousness. Stayed there roughly 6-7 hours and received fluids and magnesium before being discharged,",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/20/2021,01/20/2021,0.0,PVT,"Prozac 60 mg, Singulair 10 mg",None,Asthma,,Bees,"['Disorientation', 'Dizziness', 'Electrocardiogram abnormal', 'Hypotension', 'Immediate post-injection reaction', 'Loss of consciousness', 'Pyrexia', 'Tachycardia']",UNK,MODERNA,SYR 990956,IL,91.0,M,Systemic: Other- Patient passed away,Yes,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/12/2021,0.0,SEN,,,,,,['Death'],1,PFIZER\BIONTECH,IM 991060,PA,88.0,M,"Fever 101.1, unresponsive episode. Transferred to Hospital on 1/28. Diagnosis there was anemia and CHF, aware that he had vaccine day prior. Transfused with 2 units pRBC's. Transferred back to Nursing Home on 1/30 and passed away 0140 1/31/2021",Yes,01/31/2021,Not Reported,Yes,2.0,Not Reported,N,01/27/2021,01/28/2021,1.0,SEN,"Lisinopril 10mg daily, Lasix 40 mg daily, Simvastatin 40 mg daily, Senna 8.6/50mg twice daily, Namenda XR 28mg daily, Protonix 40mg daily, ASA 81 mg daily, Potassium Chloride ER 10 meq daily, Amiodarone 100mg daily, metoprolol 25 mg daily.","Dementia, heart failure, paroxysmal atrial fib.. BHP, HTN, thorasic aortic aneurysm, polyosteoarthritis, history of falls, anemia",as above Resident was transferred to hospital on 1/28/21. Returned to nursing facility on 1/30 and passed away on 1/31/21.,,NKA,"['Anaemia', 'Cardiac failure congestive', 'Condition aggravated', 'Death', 'Packed red blood cell transfusion', 'Pyrexia', 'Unresponsive to stimuli']",2,MODERNA, 991080,MA,69.0,M,Patient sudden death reported by family. No further details available at this time.,Yes,01/06/2021,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/06/2021,9.0,PVT,Unknown,Unknown,Unknown,,Unknown,['Sudden death'],1,MODERNA,IM 991101,NC,62.0,M,"Patient reports having his flu vaccination in November 2020 and his Pfizer COVID-19 vaccination on 12/22/2020. 10 days later he noticed bilateral leg cramps subsequently leading to numbness in his feet, weakness in his feet, numbness on side of his legs, both hands and upper back. 2 to 3 days prior to admission on 1/2/21 he has noticed right-sided facial weakness andhas noticed increasing shortness of breath on exertion. He was initially seen by PCP who suspected Guillain-Barr� syndrome and had a PFT done which showed reduced tidal volume and FEV1 He was seen by neurologistand had EMG nerve conduction studies which confirmed demyelination & patient has been sent to the hospital for IVIG treatment. Per PT note from 1/30: ""UE ROM: WFL UE Strength: WFL, reports grip weaker from baseline LE ROM: WFL LE Strength: proximal WFL, ankle DF/ PF 2+/3-/5 ����������� Coordination: reports no deficits with finger to nose B Sensation: numbness B hands; B feet numbness and reports weight bearing feels like standing on something squishy Balance: WFL over level surfaces, able to compensate with strength Posture: midline Other: R side facial droop, able to close R eyelid Bed Mobility: mod independent Transfers: modified independent, no device; able to perform controlled eccentric lowering stand > sit Gait Level of Assistance: Modified independent, requires aide device or extra time Assistive Device: None Distance Ambulated (ft): 10 ft Gait: pt ambulating in room without device, appears mildly unsteady with decreased heel strike with increased foot flat contact, mild increased lateral postural sway (increased with retrowalk). No frank LOB. Stairs: verbally reports has been performing stairs sineonset of symptoms, stairs are hard but able to perform, improved with UE support when available, requires increased time and fatigues quickly Endurance: neuromuscular fatigue, requires increased rest breaks"" He was admitted to hospital from 1/28-2/2 for 5 treatmens of IVIG. He had improvement of his SOB and numbness but has not had full resolution of symptoms.",Not Reported,,Not Reported,Yes,5.0,Yes,U,12/22/2020,01/01/2021,10.0,PVT,"chlorthalidone, dapagliflozin-metformin, armour thyroid, melatonin",none but had flu vaccine in Nov of 2020,diabetes,,none,"['Balance disorder', 'Demyelination', 'Dyspnoea', 'Dyspnoea exertional', 'Electromyogram abnormal', 'Facial paralysis', 'Facial paresis', 'Fatigue', 'Forced expiratory volume', 'Forced expiratory volume decreased', 'Gait disturbance', 'Grip strength decreased', 'Guillain-Barre syndrome', 'Hypoaesthesia', 'Immunoglobulin therapy', 'Muscle fatigue', 'Muscle spasms', 'Muscular weakness', 'Nerve conduction studies abnormal', 'Pulmonary function test abnormal', 'Tidal volume decreased']",1,PFIZER\BIONTECH,IM 991117,CA,90.0,F,"Systemic: Other- pt had history of copd and DNR on file. approx 3 1/2hr after vaccine pt had sob and lowo2 sat, emergency services called, pt passed on their arrival.staff felt due to pt existing condition",Yes,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,SEN,,,,,,"['Death', 'Dyspnoea', 'Oxygen saturation decreased']",2,PFIZER\BIONTECH,IM 991151,VA,57.0,M,"Morerna 2 vaccine was admitted on Jan. 24 at 3:45 pm from the Hospital. Mild Cheer, muscle, fever and diarrhea on 25th. On 26th, Moderate symptoms abdominal pain. On 27, Mod localized Abdominal pain developed and 28the 4:30 am entered to ER. Blood work and CT done. Dx: Appendicitis . Transferred to higher level of care OR at 3pm and Surgery was done at 5:00pm with Appendicitis with burst. Discharged from hospital on 30 th at 2pm",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/24/2021,01/25/2021,1.0,OTH,None,None,None,,None,"['Abdominal pain', 'Appendicitis', 'Blood test abnormal', 'Computerised tomogram abdomen abnormal', 'Diarrhoea', 'Muscle disorder', 'Pyrexia', 'Surgery']",UNK,MODERNA, 991187,IL,63.0,F,"Developed hives within 2 hrs/took Benadryl that night; swelling that traveled up the arm and neck in the morning with shortness of breath/used rescue inhaler at 0400 and then again at 0800; and then anaphylaxis by 0900. Treated in ED with EpiPen then IV Solumedrol, Benadryl and Famotidine. Recovered and started on prednisone taper pack starting at 6 tabs for 3 days etc. Suggested to make follow up Dr appt for one week following incident/set for Feb 8",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,WRK,"Zyrtek, Omeprazole, Zetia, Aleve, Singular",Severe reaction to this years flu shot end of October: Fever 103.4 for 4 days which started 3 days after receiving the vaccine-2 Neg COVID tests during that time period,"asthma, allergies, OA, elevated cholesterol, GERD",Extreme immune response this past OCT after this year's flu vaccine. Elevated fever of 103.4 for 4 days,"Cantaloupe, Lilium Candidum (Lilies), Macadamia Nut, Ragweed, Codeine, Poison Ivy, and intolerance to Statins","['Anaphylactic reaction', 'Dyspnoea', 'Peripheral swelling', 'Swelling', 'Urticaria']",2,MODERNA,IM 991213,VA,32.0,M,"Heart swelling (pericarditis) , abnormal EKG showing STEMI initially on Saturday approximately 3 days after 2nd vaccine dose administration.",Not Reported,,Not Reported,Yes,2.0,Yes,N,01/19/2021,01/23/2021,4.0,SEN,Prozac Adderall (I have since discontinued),none,None,,NONE NKDA,"['Acute myocardial infarction', 'Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood creatine phosphokinase increased', 'Electrocardiogram abnormal', 'Full blood count normal', 'Pericarditis', 'Troponin increased', 'White blood cell count normal']",2,PFIZER\BIONTECH,IM 991216,KS,70.0,M,"Vaccine given on 01-25-2021. Wife reported on 01-29-2021 that patient had a ran a fever on 01-26-2021, Was better on 01-27-2021. She found him dead when she came home work on the evening of 01-28-2021.",Yes,01/28/2021,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/28/2021,2.0,PVT,Unknown,,History of Heart Condition,,NKDA,"['Death', 'Pyrexia']",1,MODERNA,IM 991251,MO,27.0,F,"Headache right after vaccine was administered. Approximately 40min after vaccine was administered I had severe dry mouth, inability to swallow, at about an hour after vaccine was administered my lips tongue and throat were swelling. Diarrhea, chills, dizziness, severe tremors.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/29/2021,01/29/2021,0.0,UNK,"Ritual prenatal vitamins, maca root, and black seed oil",No.,No.,,Simple hay fever in the spring,"['Chills', 'Diarrhoea', 'Dizziness', 'Dry mouth', 'Dysphagia', 'Headache', 'Immediate post-injection reaction', 'Lip swelling', 'Pharyngeal swelling', 'Swollen tongue', 'Tremor']",1,PFIZER\BIONTECH,SYR 991331,FL,30.0,F,"My white blood count went really high; The first dose was on 28Dec2020 and the Lot: EH9899. The second dose 12Jan2021 at 7am, Lot: EL1284; Extremely achy/Body aches; Chills; Back hurts so bad that she can't lay down; Sweating; The first round of the vaccine she had flu like symptoms. This time, with the second dose, it is more severe; The first round of the vaccine she had flu like symptoms. This time, with the second dose, it is more severe; This is a spontaneous report received from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), via an unspecified route of administration in the right arm, on 12Jan2021 07:00, at single dose, for COVID-19 immunization, in the hospital. The patient medical history and concomitant medications were not reported. The patient had no allergies. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), via an unspecified route of administration, on 28Dec2020, for COVID-19 immunization and the patient had flu-like symptoms. The patient reported that with the first round of the vaccine, she had flu like symptoms. This time in Jan2021, with the second dose, it was more severe and if she didn't keep up with Tylenol, she was extremely achy, had chills, her back hurts so bad that she couldn't lay down, and sweating. The patient wanted to know if that was normal. The patient mentioned she called out of work for the rest of the week and left early on Tuesday. The patient stated that she had not been to the doctor at this point but when Tylenol wears off it was really ugly and would consider going. The patient stated that she was almost on septic. Her white blood count went really high on 12Jan2021 and was hospitalized from 16Jan2021. She was put on Cefepime, 2 gm per vial, gotten maybe 4 of them so far. Body aches was ongoing. Her blood work was getting better. The outcome of events white blood count went really high, extremely achy/body aches was not recovered.The outcome of other events was unknown. Follow-up (17Jan2021): New information from a contactable consumer (patient) includes: Reaction data (add event white blood count went really high, outcome of event extremely achy/body aches updated). This case has been upgraded to serious.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/12/2021,01/01/2021,,PVT,,,,,,"['Back pain', 'Chills', 'Hyperhidrosis', 'Impaired work ability', 'Pain', 'White blood cell count increased']",2,PFIZER\BIONTECH, 991336,OR,73.0,M,Systemic: Other- Bells Palsey diagnosed 1/26/21 at hospital,Not Reported,,Not Reported,Yes,,Not Reported,,01/21/2021,01/25/2021,4.0,SEN,,,,,,['Facial paralysis'],UNK,PFIZER\BIONTECH,IM 991343,,79.0,M,"Patient admitted to hospital with COVID-19 virus infection; Cardiovascular disease; Dyspnea, unspecified type; SOB (shortness of breath). Still admitted.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/30/2021,01/30/2021,0.0,PVT,,,,,no known allergies,"['COVID-19', 'Cardiovascular disorder', 'Dyspnoea']",2,PFIZER\BIONTECH, 991397,,88.0,M,A-fib; Acute on chronic heart failure; Pacemaker; Tachycardia; VT (ventricular tachycardia),Not Reported,,Not Reported,Yes,,Not Reported,,01/30/2021,01/30/2021,0.0,UNK,,,,,,"['Atrial fibrillation', 'Cardiac assistance device user', 'Cardiac failure acute', 'Tachycardia', 'Ventricular tachycardia']",2,PFIZER\BIONTECH, 991425,TX,70.0,F,"Pt received her Pfizer vaccine. During post vaccine monitoring she began to complain of not feeling well. Pt complained of lightheaded/dizziness, headache, and weakness and transferred to wheelchair. Vital signs monitored (148/77, spo2 100%). Patient stated this is above her baseline and not usual. Patient began to complain of chest pressure and was transferred to EMS stretcher to continue to monitor and transferred to hospital.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/29/2021,01/29/2021,0.0,PVT,,,,,"Azithromycin, contrast media, pencillins, sulfa drugs, adhesives.","['Asthenia', 'Chest discomfort', 'Dizziness', 'Headache', 'Malaise']",1,PFIZER\BIONTECH,IM 991481,,97.0,M,COVID-19; Chronic heart failure with preserved ejection fraction; Elevated brain natriuretic peptide (BNP) level; Fatigue; Hypokalemia; Hyponatremia; Need for vaccination,Not Reported,,Not Reported,Yes,,Not Reported,,01/30/2021,01/30/2021,0.0,UNK,,,,,,"['Brain natriuretic peptide increased', 'COVID-19', 'Cardiac failure', 'Fatigue', 'Hypokalaemia', 'Hyponatraemia']",2,PFIZER\BIONTECH, 991508,,87.0,F,Acute on chronic diastolic congestive heart failure; Epistaxis; Hypoxia; Shortness of breath,Not Reported,,Not Reported,Yes,,Not Reported,N,01/30/2021,01/30/2021,0.0,UNK,,,,,,"['Cardiac failure acute', 'Cardiac failure congestive', 'Dyspnoea', 'Epistaxis', 'Hypoxia']",UNK,PFIZER\BIONTECH, 991535,PA,34.0,M,"Fever, rapid heart rate, and flu like symptoms within 6 hours of receiving vaccine. Extreme abdominal pain coupled with fever began again in the night of 01/26-01/28/2021. Extreme abdominal pain continued and I had to have emergency appendectomy on 01/30/2021.",Not Reported,,Yes,Yes,1.0,Not Reported,N,01/13/2021,01/28/2021,15.0,PVT,,,,,,"['Abdominal pain', 'Appendicectomy', 'Heart rate increased', 'Influenza like illness', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 991536,LA,57.0,F,Patient states felt hot flashes following injection in waiting room went home became lethargic that evening having difficulty answering questions at night patient states she became apneic and husband had to watch her breathe. Did not go to the ER. Patient states fully recover the next day and fully recovered 5 days later. No rashes fever generalized weakness that resolved.,Not Reported,,Yes,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,OTH,"vit D3, atorvastatin, hydrocholorthiazide, losartan, metformin, jardiance, soliqua, aspirin, biotin,",COVID + on 1/12/2021,"type 2 DM, HTN, hyperlipidemia, Depression. vit D defiency.",,"Demerol, Vicodin, Norco,","['Apnoea', 'Asthenia', 'Hot flush', 'Lethargy', 'Mental impairment', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 991540,AZ,89.0,F,"Systemic: Vomiting-Medium, Systemic: Other- low blood pressure-Medium",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/20/2021,01/22/2021,2.0,SEN,,,,,,"['Hypotension', 'Vomiting']",1,MODERNA,IM 991555,NY,65.0,F,"Paresthesias of left hand, general malaise, fatigue, ? HTN urgency ? however missed HTN med doses at the time of evaluation",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,acetaminophen 325 MG Oral tablet aspirin 81 MG Oral EC tablet atorvastatin 40 MG Oral tablet metoprolol succinate 50 mg 24 hr ER,None,Hypertension Dyslipidemia Coronary Artery Disease Tobacco Dependence Elevated LFTs,,Lisinopril Latex,"['Brain natriuretic peptide normal', 'Differential white blood cell count normal', 'Electrocardiogram normal', 'Fatigue', 'Full blood count normal', 'Hypertensive urgency', 'Malaise', 'Metabolic function test normal', 'Paraesthesia', 'Product dose omission issue', 'Troponin normal']",2,PFIZER\BIONTECH,IM 991562,AZ,73.0,M,"Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Other- multiple falls-Severe",Not Reported,,Not Reported,Yes,,Not Reported,,01/20/2021,01/22/2021,2.0,SEN,,,,,,"['Fall', 'Fatigue', 'Pyrexia']",1,MODERNA,IM 991622,MA,90.0,F,Death,Yes,01/29/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,SEN,81 mg Aspirin Prevident 5000 Pepcid 20 mg Propafenone 150 mg Biscodyl Suppository Milk of Magnesia Acetaminophen 325 mg Miralax Powder Ferrous Sulfate 325 mg,"Cerebral Infarction due to embolism Crohn's Disease Gastric Reflux Hyperlipidemia HTN SENILE DEGENERATION OF BRAIN, NOT ELSEWHERE CLASSIFIED PRIMARY GENERALIZED (OSTEO)ARTHRITIS",See Item 11,,Adhesive Tape (intolerance) Procaine (intolerance),['Death'],2,PFIZER\BIONTECH,IM 991677,IL,63.0,F,"got up in the night and stated that she couldn't breath, ambulance was called, pt expired in route to hospital. *relayed to me by Facility staff RN.",Yes,01/31/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/30/2021,9.0,PUB,,diagnosed with Covid on 12/03/2020,"hypertension, hyperlipidemia, diabetes, GERD",,"Sulfa, Flexeril, trimethoprim","['Death', 'Dyspnoea']",1,MODERNA,IM 991686,TX,39.0,F,"Pfizer-BioNTech COVID- 19 Vaccine Patient experienced nausea and palpitation approximately 2 hours post COVID-19 vaccine dose #2. Presented to emergency department and found to have new onset atrial fibrillation with rapid ventricular rate (pulse 155), and dehydration. Patient treated with metoprolol 5 mg IV and aspirin 325 mg orally, and subsequently converted to normal sinus rhythm. Patient admitted for observation and discharged with resolution of symptoms on 1/29/2021.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/28/2021,01/28/2021,0.0,PVT,"Ergocalciferol Daily, Fish Oil Daily, Multivitamin Daily",,None,,Eggs,"['Atrial fibrillation', 'Dehydration', 'Heart rate increased', 'Nausea', 'Palpitations']",2,PFIZER\BIONTECH,IM 991730,MI,40.0,F,"Patient administered 2nd dose of Pfizer COVID vaccine on 1/25/2020. Six days later the patient developed generalized hives treated with over the counter antihistamine (benadryl). The next day patient again had hives, trouble swallowing, and difficulty breathing. She presented to an Emergency Department and was treated with epi IM and oral antihistamines (H1 and H2). Discharged to home on prednisone 40 mg PO QD x 3 days and then 20 mg PO QD x 2 days. Patient again had trouble breathing 2/1/2020 and returned to the ED. Patient 10 weeks pregnant.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/30/2021,5.0,PVT,"Vitamin C, docusate sodium, Allegra, pre-natal vitamin, ibuprofen",none,none,,cephalosporins (anaphylaxis) levothyroxine (anaphylaxis) penicillin (anaphylaxis),"['Dysphagia', 'Dyspnoea', 'Pregnancy', 'Urticaria']",2,PFIZER\BIONTECH,SYR 991738,MI,54.0,F,"Dizziness and weakness; Numbness and tingling; Other ADVERSE REACTION Reported: Electrolyte imbalance requiring hospitalization for More than 48 hours with repeated hematology follow up. Patient is a 54-year-old woman with history of Roux-en-Y gastric bypass surgery and some alcohol abuse who presented to the hospital with fatigue, headache, muscle cramps and weakness. She also had a slight fever that followed her 2nd dose of COVID-19 vaccine. She had basic lab work which revealed pancytopenia along with multiple electrolyte disturbances including hypokalemia, hypomagnesemia, hypocalcemia and hyponatremia. She admits that she had heavy alcohol use over the weekend with binge drinking of liquor. She otherwise does drink a couple of mixed drinks a night. She has also been trying to lose a lot of weight. She says that she lost about 60 lb in the last 6 months on purpose. She is doing this so that she can have a panniculectomy and tummy tuck. She recently had a breast reduction in November. She has not been following with a dietitian or having her vitamin levels checked. Despite having pancytopenia, her levels remained pretty stable during her stay. She had a peripheral smear sent which was pending at the time of discharge. She was also checked for vitamin deficiencies. She is given a dose of IM B12, IV iron, IV calcium and started on oral calcium vitamin-D supplements. She does take a daily multivitamin. Due to her reported history of heavy alcohol use she is also given thiamine and folate. After speaking with Hematology, recommendations were for her to have a follow-up appointment which is scheduled on February 10th. I also put in a referral for a dietitian to evaluate her for further recommend deficiencies in the setting of Roux-en-Y gastric bypass surgery with heavy weight loss. I prescribed her calcium vitamin-D along with folic acid. I recommended she continue her multivitamin. I also recommended that she abstain from alcohol use.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/26/2021,01/27/2021,1.0,PVT,ALPRAZolam; citracal; tylenol PM; EpiPen PRN; estradiol; folic acid; furosemide; metFORMIN; MVI; rOPINIRole; traMADol,some weight loss within the prior 6 months; breast reduction in Nov 2020; alcohol use,hypertension; depression / anxiety; migraines; type 2 diabetes mellitus; elevated BMI; dysplastic nevus; vitamin D deficiency; OSA; menopause; chronic opioid use; history bariatric surgery; asthma,,"iodine and shellfish (anaphylaxis); lisinopril, demerol, morphine","['Alcohol use', 'Asthenia', 'Binge drinking', 'Blood smear test', 'Dizziness', 'Electrolyte imbalance', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Hypocalcaemia', 'Hypokalaemia', 'Hypomagnesaemia', 'Hyponatraemia', 'Laboratory test abnormal', 'Muscle spasms', 'Pancytopenia', 'Paraesthesia', 'Pyrexia', 'Weight decreased']",2,PFIZER\BIONTECH,IM 991769,CA,70.0,F,"woke up disorientated and confused on 01/25 at 3 am and she is still in the ER in ICU and does not recognize anyone, she is very strong an d trying to leave hospital and pulling out IV's and catheters",Not Reported,,Not Reported,Yes,7.0,Yes,N,01/21/2021,01/25/2021,4.0,PVT,"various, including prednisone, insulin, Neurontin, spironolactone","high blood pressure, diabetes cirrhosis of the liver.","high blood pressure, diabetes cirrhosis of the liver.",,Neosporin,"['Blood test normal', 'Computerised tomogram normal', 'Confusional state', 'Disorientation', 'Intensive care', 'Magnetic resonance imaging normal', 'Memory impairment']",1,PFIZER\BIONTECH,SYR 991849,MN,88.0,M,"Congestion, Hypoxia, SOB, Tachycardia, Weakness. Started on O2 @ 3L, HOB elevated, Tylenol supp",Yes,01/28/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/27/2021,2.0,SEN,"clonazepam, Flomax, Flunisolide Soln., Melatonin, Omeprazole, Miralax, Sertraline, Milk of Mag, Tylenol",,"Epilepsy, HTN, BPH, ASHD, GERD, Alzheimer's Disease, Depression, OCD",,NKA,"['Asthenia', 'Dyspnoea', 'Hypoxia', 'Respiratory tract congestion', 'Tachycardia']",2,MODERNA,IM 991859,IL,89.0,M,"Per granddaughter's report, pt became very weak within hours of receiving the first dose of the Moderna COVID-19 vaccine and could not get out of bed the next morning without assistance, reported difficulty seeing, and did not recognize some family members. By Sunday, 1/31, pt was unable to be awakened, would not eat, and had low urinary output. Granddaughter reports that the morning of 2/1 he was awake and ate a small amount and seemed to be improving although still weak and unable to get out of bed. Granddaughter reported he died 2/1 around 10am in the morning.",Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,PUB,,,hospice patient for 1 year,,,"['Asthenia', 'Death', 'Decreased appetite', 'Food refusal', 'Memory impairment', 'Mobility decreased', 'Somnolence', 'Urine output decreased', 'Visual impairment']",1,MODERNA,IM 991882,NC,75.0,M,"Patient had fever, chills, tachycardia and projectile vomiting.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/26/2021,01/27/2021,1.0,SEN,"1) ACETAMINOPHEN TAB 650MG PO TID 2) AMLODIPINE TAB 5MG PO QDAY 3) ASPIRIN TAB,EC 81MG PO QDAY 4) ATORVASTATIN TAB 10MG PO AT BEDTIME 5) CARBOXYMETHYLCELLULOSE SODIUM SOLN,OPH 3 DROPS B",1. Acute-on-chronic renal failure 2. COVID-19 3. Long-term current use of insulin16. Esophagitis 17. Cognitive impairment 4. Diabetic nephropathy 5. Dry eyes 6. Adhesive capsulitis of right shoulder 7. Oropharyngeal dysphagia 8. OA - Osteoarthritis (SCT 396275006) 9. COPD - Chronic Obstructive Pulmonary Disease (SCT 13645005) 10. Anemia of chronic disease 11. Debility 12. Major depressive disorder 13. Hyperparathyroidism due to renal insufficiency 14. Diabetes mellitus 15. Hyperlipidemia 16. Benign hypertension 17. Degeneration of lumbar intervertebral disc,patient is a LTC resident and has multiple co-morbidities,Stroke like symptoms with first dose. Though unclear if sxs related to vaccine,NKA,"['Chills', 'Pyrexia', 'Tachycardia', 'Vomiting projectile']",UNK,MODERNA,IM 991900,GA,46.0,F,Diagnosed with Bells Palsey,Not Reported,,Not Reported,Not Reported,,Yes,N,01/26/2021,01/29/2021,3.0,PVT,Lisinopril/HCTZ,Na,HTN,,Codeine/ Flexeril,['Facial paralysis'],2,MODERNA,IM 991927,ND,86.0,M,Patient was found deceased at Nursing Home in his room 01/12/2021 at 5:25 AM.,Yes,01/12/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/12/2021,7.0,PVT,"Diphenhydramine HCl, atorvastatin, furosemide, gabapentin, Healthy Eyes (vitamin A, C, & E with lutein minerals), Imodium, Isosorbide mononitrate, Jantoven, Potassium Cl, Metoprolol succinate, Nitroglycerin.",,"Constipation, acute exacerbation of chronic congestive heart failure , osteoarthritis, mitral and aortic incompetence, abnormal renal function, hernia of abdominal cavity, polyp of colon, coronary arteriosclerosis, atrial fibrillation, aortic valve stenosis, aortic valve disorder, cerebrovascular disease, long term current use of anticoagulant, sick sinus syndrome, edema, gout, angina co-occurrent and due to coronary arteripolyneuropathy, essential hypertension, mixed hyperlipidemia, chronic kidney disease stage 3, chronic systolic heart failure, angina, prosthetic cardiac paravalvular leak, prosthetic heart valve in situ, aortic stenosis-non-rheumatic, macrocytic anemia, diarrhea-occasionally, heart disease, cerebrovascular accident, old MI, Squamous cells carcinoma of skin of face, long QT syndrome- 6/18/2020 PPM placed.",,No known defined allergies.,['Death'],1,MODERNA,IM 991937,FL,92.0,M,"weakness in legs, difficult to get out of chair, fell and could not get up. fever loose stool Went into AFIB and it snowballed from there. Was taken to Emergency.",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,01/20/2021,01/21/2021,1.0,OTH,"Coreg, Eliquis Vitamin D",N/a,Congestive heart failure - under control,,Sulfa,"['Atrial fibrillation', 'Blood test', 'Computerised tomogram', 'Condition aggravated', 'Diarrhoea', 'Dysstasia', 'Fall', 'Full blood count', 'Muscular weakness', 'Pyrexia']",1,MODERNA,SYR 991994,CA,68.0,F,"Ache in the arm side of the shot for few days, followed by headache 3-4 days later associated with tremors. Then was seen by a health care provider on Jan 28th, Symptoms worsen, and was admitted to ER on January 31, 2020. The situation persists. She has not shown neurological symptoms prior.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/26/2021,5.0,PVT,"Thyroid Medications Levothyroxine 75 Mg), Cholesterol Medication Atorvastatin 10 mg",Arteritis,Arteritis,,None,"['Blood test', 'Brain natriuretic peptide', 'Full blood count', 'Headache', 'Injection site pain', 'Intensive care', 'Metabolic function test', 'Pain in extremity', 'Tremor', 'Troponin I', 'Urine analysis']",1,MODERNA,SYR 991997,MN,71.0,F,"Resident c/o nausea evening of 1/29 (nausea common for her post dialysis), had a large emesis at approx 2220, 0030 (unusual for resident to vomit)- received Zofran per order. Skin cool and damp, Blood sugar 147 (checked due to h/o diabetes and poor intake). At approx 230am Blood pressured checked and noted to be 52/29. Resident transferred to ER, intubated and transferred to higher level of care where she passed away on 1/30 at 736pm. Resident's medical notes indicated likely shock, cardiogenic in nature, sepsis (source unknown) along with a multitude of other co-morbidities that resident has.",Yes,01/30/2021,Not Reported,Yes,1.0,Not Reported,N,01/28/2021,01/30/2021,2.0,SEN,"Tylenol, Levemir, Humalog, Trazodone, Prozac, Metoprolol, Eliquis, Plavix, Atorvastatin, Pantoprazole, Dialyvite, Renagel",COVID + diagnosis (12/17/2020) ASYMPTOMATIC Multiple oral extractions completed by dentist on 1/26/2020 ESRD (on 3x week dialysis-last date of dialysis 1/29/2020),"ESRD, Diabetic, Heart Disease, Vascular Disease, HTN,",,"Bactrim/Sulfa, Cyclobenzaprine, Fentanyl, Gabapentin, Lisinopril, Metoprolol, Primidone","['Blood glucose increased', 'Blood potassium increased', 'Cardiogenic shock', 'Cold sweat', 'Death', 'Endotracheal intubation', 'Nausea', 'Sepsis', 'Troponin increased', 'Vomiting', 'White blood cell count increased']",1,MODERNA,IM 992000,MI,45.0,F,Liver test abnormalities,Not Reported,,Not Reported,Yes,5.0,Not Reported,U,01/04/2021,01/05/2021,1.0,PVT,"nexium, tums",Hep C infection detected,"anxiety, depression, HPV with ASCUS",,none,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood alkaline phosphatase increased', 'Blood bilirubin increased', 'Liver function test abnormal']",UNK,MODERNA, 992035,CA,44.0,F,"Anaphylaxis: hives all over her body, lightheadedness, throat closing. Hypotension about 2 hours after the moderna was administered.. She received 2 doses of epipen before paramedics took her to the ER.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,PVT,none,none,none,,none,"['Anaphylactic reaction', 'Dizziness', 'Hypotension', 'Throat tightness', 'Urticaria']",1,MODERNA,IM 992041,IN,54.0,F,shortness of breath---in hospital for a few days and inflamatory response,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/27/2021,01/27/2021,0.0,PVT,slo mag,no,diabetic asthma,,sulfa shellfish bee venom,"['Blood test', 'Chest X-ray', 'Computerised tomogram thorax', 'Dyspnoea', 'Electrocardiogram', 'Inflammation']",2,MODERNA,IM 992052,CA,81.0,F,"My parents do not have a smart phone so they cannot participate in the mobile app to report symptoms. I understand that there may or may not be a link between my mother's symptoms and the vaccine, but I want to make sure that it is looked into. Three days after dose, my mother woke up with shortness of breath. Over the last week, the shortness of breath has lingered and she has also had stomach issues. She has now been hospitalized since yesterday. These are not uncommon symptoms with her, but she has definitely been worse since the vaccine. Assuming she recovers, I am concerned about her taking the second dose, scheduled in two weeks. Her symptoms are very similar to those of a Physician in an article I read today.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/17/2021,01/20/2021,3.0,OTH,"Many for rheumatoid arthritis, diabetes, blood pressure, etc.","rheumatoid arthritis, diabetes, anemia","rheumatoid arthritis, diabetes, high blood pressure",,None,"['Abdominal discomfort', 'Dyspnoea']",1,MODERNA,IM 992061,MO,49.0,F,"Patient began having increasing shortness of breath about a week after receiving first dose of Pfizer COVID-19 vaccine. Symptoms worsened and persisted to the point where patient called her PCP on 1/26/2021, who advised her to report to ED if experiencing worsening symptoms and/or low oxygenation. Patient reported to ED on 1/29/2021 due to tachycardia and O2 sats <90%. On presentation, patient was found to have bilateral pulmonary emboli involving the upper and lower lobe regions bilaterally including segmental branches without evidence of right heart strain.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/15/2021,01/22/2021,7.0,PVT,"Alprazolam, Symbicort, Nuvaring, Ventolin, Zolpidem",No acute illnesses,"Depression, anxiety, restless legs syndrome Persistent shortness of breath post-COVID-19 - diagnosed 9/30/2020",,None,"['Blood lactic acid increased', 'Computerised tomogram abnormal', 'Condition aggravated', 'Dyspnoea', 'Fibrin D dimer increased', 'Pulmonary embolism', 'SARS-CoV-2 antibody test', 'Tachycardia', 'Ultrasound Doppler']",1,PFIZER\BIONTECH,IM 992063,WI,80.0,M,"Patient received first dose of the COVID-19 Moderna vaccine on 1/19/2021 at an outside facility (no lot #, route, or site available to me in electronic charting). Pt began having hypoxia, SOB, and a dusky appearance of extremities on 1/29/2021 and was brought by EMS to our hospital. PT is a DNR and family had been looking into a hospice sign up due to dementia and general decline in the weeks prior to hospitalization. Pt tested positive on admission for COVID-19 via PCR test on 1/29/2021. Pt continued to have respiratory decline, was put on comfort care per wishes of family/advanced directives, and he passed away the evening of 1/30.",Yes,01/30/2021,Not Reported,Yes,,Not Reported,,01/19/2021,01/29/2021,10.0,UNK,"Tums, folic acid, hydroxychloroquine (pre-existing prescription to pandemic), pain pump, symbicort inhaler, multi-vitamin, albuterol inhaler, duloxetine, nystatin powder, senna-docusate, tofacitinib citrate, probiotic, polyethylene glycol,",,"Vascular dementia, swelling of left lower extremity (chronic), subclinical hypothyroidism, STEMI (2014), rheumatoid arthritis, postinflammatory pulmonary fibrosis, posterior tibial tendon dysfunction, paroxsymal atrial fibrillation, osteoporosis, OSA on CPAP, microscopic colitis, interstitial lung disease, hypertension, hx of squamous cell carcinoma of skin, hx of basal cell carcinoma, hearing loss, gout, GERD, dyspnea on exertion, dyslipidemia, diverticulitis, HX of CVA, COPD, chronic heart failure w. preserved ejection fraction, chronic back pain, carotid artery stenosis, CAD, BPH, Barrett's esophagus, asthma, anxiety, allergic rhinitis, actinic keratosis.",,"Amoxicillin (N&V), ""poison ivy/treatments""","['Death', 'Dyspnoea', 'Hypoxia', 'Respiratory depression', 'SARS-CoV-2 test positive', 'Skin discolouration']",1,PFIZER\BIONTECH, 992082,GA,70.0,F,"Resident was noted on 1/25 with an increased functional decline as she would not feed herself with utensils, but would eat finger foods if placed in her hand. She was started on Rocephin IM for possible infections. Labs had been obtained on 1/21/21, unremarkable for CBC and CMP. 75,000 colony count on urine. On 1/26/21 she was noted with right sided weakness and further decline. She was sent to Hospital for further evaluation. We were notified that she expired on 1/28/2021. Resident had been noted with a decline in function about 2 weeks earlier when she would not stand or transfer any longer. She was still responsive, taking meds, and feeding herself until 1/26/21. Further information on admitting diagnoses and progress notes from hospital have not been available to date.",Yes,01/28/2021,Not Reported,Yes,2.0,Not Reported,N,01/24/2021,01/25/2021,1.0,SEN,"Rocephin, depakote sprinkles, metoprolol, trazodone, famotidine, certevite, mylanta, vit D, zocor, keppra, aspirin, tylenol, tricor.",None,"Supraventricular Tachycardia, cerebral palsey, epilepsy,",,NKA,"['Culture urine negative', 'Death', 'Full blood count normal', 'General physical health deterioration', 'Hemiparesis', 'Metabolic function test', 'Metabolic function test normal', 'Mobility decreased']",2,PFIZER\BIONTECH,IM 992110,FL,33.0,F,"Uncomplicated pregnancy but mother has type 1 diabetes and hypothyroidism monitored by regular OB and high risk MFM. On 1/31/21, I developed discharged of clear vaginal fluid later diagnosed at the hospital with preterm premature rupture of the membranes.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/22/2021,01/31/2021,9.0,PHM,Levothyroxine Humalog Aspirin Prenatal vitamins Prenatal DHA,None,Type 1 diabetes Hypothyroidism,,None,"['Discharge', 'High risk pregnancy', 'Preterm premature rupture of membranes', 'Vaginal discharge']",1,MODERNA,IM 992123,MA,20.0,M,"Acute myocarditis with chest pain and elevated troponin with EKG ST segment changes, muscle aches",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/26/2021,01/30/2021,4.0,WRK,"Dupixent, Albuterol, Zyrtec, Montelukast, Symbicort",None,Asthma Food allergy,,"Egg, Peanut, Treenut","['Chest pain', 'Electrocardiogram ST-T change', 'Electrocardiogram ST-T segment elevation', 'Myalgia', 'Myocarditis', 'Troponin increased']",2,MODERNA,IM 992137,SC,74.0,M,6 days after vaccine developed bloody diarrhea. Thought to have ischemic colitis but negative evaluation. became hypotensive bradycardic placed on ventilator. Subsequently was poorly responsive and eventually coded once more and succumbed,Yes,01/31/2021,Not Reported,Yes,5.0,Not Reported,N,01/19/2021,01/25/2021,6.0,PVT,"oxymorphone ,mertazapine,medical marijuana , duloxetine , lisinopril , monolucast, hydocortisone, simvastatin amlodipine famotidine",,"pan-hypo pituitarism, hypertension, hyperlipidemia chronic pain sleep apnea",,,"['Bradycardia', 'Cardio-respiratory arrest', 'Death', 'Diarrhoea haemorrhagic', 'Hyporesponsive to stimuli', 'Hypotension', 'Mechanical ventilation']",1,MODERNA,IM 992154,MN,100.0,M,No adverse events reported post vaccine. 1 st dose on 1/11/21 by public health. Death 1/31/21 Patient was on hospice for gradual decline.,Yes,01/31/2021,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/25/2021,14.0,SEN,"duo neb, lasix, protonix, prednisone, apap , dulcolax, cough syryp, levsin, MOM, morphine, tums, ativan, flomax, aquaiphor oint, senna, muscle rub",None,"Alzheimers Dementia late onset without behavioral disturbance, Hypotension, benign prostatic hyperplasia, Left inguinal hernia found 2016, Left shoulder lesions, Hypothyroidism, GERD (gastroesophageal reflux disease), Mixed hyperlipidemia, Basal Cell Carcinoma, Kyphosis, Hx of shingles, dysphagia, Legally blind LEFT eye, cataracts both eyes, frality, hard of hearing Hospice- general decline in the past year.",,NKA,['Death'],1,MODERNA,IM 992192,OH,46.0,F,I have not had any issues with a bechet's/crohn's flareup since diagnosed many years ago. I received my first covid vaccine on 12/29/21. On 1/6/21 I was admitted for small bowel obstruction due to major inflammatory attack. I was admitted for 2 days and placed on high dose steroids. I went home on 1/8/21 but was unable to progress past liquid diet due to the inflammation/scarring from this event so was admitted hospital on 1/21/21 and had small bowel resection. I was discharged from there on 1/27/21. My concern is that the vaccine could have triggered this major inflammatory response in my body as I was doing so well prior to that vaccine.,Not Reported,,Not Reported,Yes,9.0,Yes,Y,12/29/2020,01/06/2021,8.0,PVT,stelara,none,Bechet's/chron's disease,,none,"['Computerised tomogram abdomen', 'Condition aggravated', 'Feeding disorder', 'Inflammation', 'Laboratory test', 'Small intestinal obstruction', 'Small intestinal resection']",1,MODERNA,SYR 992209,AK,82.0,F,Death,Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/30/2021,22.0,SEN,"Lorazepam, Haloperidol, Morphine",Hyperlipidemia,Hyperlipidemia,,"NKDA, NKFA",['Death'],2,PFIZER\BIONTECH,IM 992237,MO,42.0,M,"1/28/2021- Seen by FNP for indigestion, chest pressure and palpitations. EKG reviewed and referral made to Cardiology. 1/29/2021-1800 Presented to ED in cardiac arrest-onset PTA. Patient was found unresponsive by his wife at their home. The last known well was at 1530 when she called him on the phone. The patient was pronounced at ~1850.",Yes,01/29/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/29/2021,4.0,PVT,Nebivolol 5mg; Pantoprazole 40 mg; Levocetirizine dehydrochloride 10 mg,,Hypertension; Hyperlipidemia; decreased GFR. Family history of CAD,,None,"['Cardiac arrest', 'Cardioversion', 'Chest discomfort', 'Death', 'Dyspepsia', 'Electrocardiogram', 'Endotracheal intubation', 'Mechanical ventilation', 'Palpitations', 'Unresponsive to stimuli']",UNK,PFIZER\BIONTECH,IM 992238,MI,70.0,M,"Tested positive for COVID19 on 12-30-2020, Admitted to Hospital on 1/5/2021 with active COVID, Patient died 1/29/2021.",Yes,01/29/2021,Not Reported,Yes,24.0,Not Reported,N,12/16/2020,01/05/2021,20.0,PVT,Metoprolol sitagliptin/metformin glipizide pioglitazone folic acid rivaroxaban tadalafil aspirin atorvastatin lisinopril nephrocaps omeprazole,,ischemic heart disease hypertension diabetes mellitus type 2 gastroesophageal reflux disease hyperlipidemia obstructive sleep apnea obesity,,Plavix,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 992257,OK,61.0,M,I was asked to sit down for 15 mins in the observation chair. I started to feel a warm feeling in the arm went back to work.The next day arm was sore at the injection site went away that night. On Friday night started vomiting and diarrhea at the same time.After 3 days following Monday I went to ER stayed 2 wks 12 days with blockage small intestine.,Not Reported,,Not Reported,Yes,26.0,Not Reported,N,12/28/2020,01/01/2021,4.0,PVT,"Norvac, High blood pressure (doesn't remember the name),Potassium, Hydroxyzine",No,High blood pressure(it is under control),,No,"['Diarrhoea', 'Feeling hot', 'Injection site pain', 'Laboratory test', 'Small intestinal obstruction', 'Vomiting', 'X-ray']",1,PFIZER\BIONTECH,IM 992327,MO,70.0,M,Diffuse rash peticheal No sob,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/20/2021,01/26/2021,6.0,UNK,Advair Norvasc Fish oil,None,Htn Dyslipidemia Copd,,Chantix,['Petechiae'],UNK,PFIZER\BIONTECH, 992335,VA,22.0,M,STARTED WITH BODY ACHES ON DATE OF VACCINATION WITH POSSIBLE TEMP. ON FRIDAY (2 DAYS POST) PT. WOKE UP WITH JAW PAIN AND SHORTNESS OF BREATH.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/27/2021,01/27/2021,0.0,PVT,none,none,none,,none,"['Atrioventricular block', 'Catheterisation cardiac abnormal', 'Dyspnoea', 'Electrocardiogram abnormal', 'Pain', 'Pain in jaw', 'Troponin increased']",2,MODERNA,IM 992338,MA,31.0,M,"Pulmonary embolism, with pulmonary infarct",Not Reported,,Yes,Yes,3.0,Not Reported,N,01/26/2021,01/29/2021,3.0,OTH,none,Covid-19,none,,none,"['Computerised tomogram thorax', 'Pulmonary embolism', 'Pulmonary infarction']",UNK,MODERNA,IM 992342,AL,77.0,M,"Shortness of Breath, decreased oxygen saturation, irregular heart rhythm, hypertension, Positive for COVID, bilateral pneumonia",Yes,01/31/2021,Not Reported,Yes,1.0,Not Reported,N,01/21/2021,01/30/2021,9.0,PVT,Baby Aspirin,none,Diabetes Type 2,,NKDA,"['Arrhythmia', 'Dyspnoea', 'Hypertension', 'Oxygen saturation decreased', 'Pneumonia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 992347,OK,78.0,M,Death,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,PVT,"hydrocodone, fentanyl, albuterol",none known,"degenerative disc disease, chronic back pain, hypothyroidism, hypertension, GERD, COPD, tobacco dependence",,NKDA,['Death'],1,MODERNA,IM 992372,OR,73.0,F,"This is a 73 year old female that received her 1st dose with Moderna vaccine on 1/8/21 at approximately 1600. Within one hour, the patient developed altered mental status and increasing weakness. She was transported to the hospital by the staff at her Assisted Living Facility for concern of a vaccine reaction. On admission, oxygen saturation was found to be 89% on room air, BP=137/86, HR=94. Labs were normal, with the exception of WBC=15 (leukocytes normal, chest xray clear, COVID test negative), and a detectable troponin=63. Head CT negative. Physical exam was only notable for 'slight superficial erythema over distal right forearm and dorsal hand. No significant edema.' The patient was treated for a possible allergic reaction to vaccine with NS bolus, methylprednisolone 125mg, famotidine 20mg, and aspirin 300mg PR. She was admitted for monitoring given continued altered mental status/weakness. The next day, she continued to show no improvement, so a head MRI was ordered. MRI showed "" 1. Numerous acute cerebral and cerebellar infarcts involving both anterior and posterior circulations consistent with a central embolic source. 2. Minimal right parietal petechial hemorrhage. 3. Moderate atrophy and moderate nonspecific white matter signal abnormalities compatible with chronic microvascular ischemia "" Neurology was consulted, who approved the start of aspirin and to continue DVT prophylaxis. The patient's advanced dementia and timeline preclude other intervention. The patient's status was DNR/DNI. The patient was discharged on hospice to her assisted living facility on 1/11/21 (with reports of continued somnolence). It was reported that date of death was 1/24/21.",Yes,01/24/2021,Not Reported,Yes,4.0,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"(1) Acetaminophen 500mg PO Q4H PRN pain (2) Albuterol inhaler 1 puff Q4H PRN (3) Cyanocobalamin 1000mg PO daily (4) Diazepam 5mg PO daily PRN anxiety (5) Ergocalciferol 48,000 units PO daily (6) Fluoxetine 20mg PO daily (7) Arnicare cream 1",,(1) Advanced dementia (2) Hypothyroidism (3) Anxiety (4) Hx falls,,"(1) Etodolac (rxn = n/v, diarrhea, SOB) (2) Bee Pollen (3) Escitalopram (rxn = 'intolerance') (4) Paroxetine (rxn = 'ineffective') (5) Venlafaxine (rxn = 'ineffective')","['Asthenia', 'Atrophy', 'Cerebral haemorrhage', 'Cerebral small vessel ischaemic disease', 'Chest X-ray normal', 'Computerised tomogram head normal', 'Death', 'Embolic cerebellar infarction', 'Embolic cerebral infarction', 'Erythema', 'Laboratory test normal', 'Magnetic resonance imaging brain abnormal', 'Mental status changes', 'SARS-CoV-2 test negative', 'Troponin increased', 'White blood cell count increased']",1,MODERNA,IM 992377,CO,70.0,M,"Got shot at 8am 22 Jan. Slight soreness in arm developed later the same day, but no problem. Everything was normal and went to bed. Woke up approximately 2-3 h later with extreme vertigo, dizziness, imbalance, completely clogged left ear, tinnitus in left hear and nausea. Within about an hour I was hyperventilating and had cold tingling sensation in hands and feet. About 2am went to hospital. They did a bunch of tests including a CT scan which revealed nothing adverse. They kept me over night and gave me an MRI the next morning. Again nothing adverse found. I was released that next day with orders to see PCP. Got an appt 2 days later. PCP immediately started me on Prednisone and referred me to ENT doctor. Got an audio test 2 days later and because of the severity of my symptoms (sudden, acute tinnitus and complete hearing loss in left ear) ENT prescribed higher dose and duration of prednisone. I am on day 5 of the 24day course prescribed by ENT with no appreciable improvement. Still have no hearing in left ear and tinnitus, imbalance and trouble focusing and walking. No causal link has been ascribed to the vaccine, but I am terrified of having the booster shot which is schedule for 12 Feb.",Not Reported,,Not Reported,Yes,2.0,Yes,N,01/01/2021,02/01/2021,31.0,PUB,"Pseudophedrine, atorvastatin, joint supplement (chondroitin/glucosamine)",Very slight vertigo on 2 short occasions a few days prior to vaccination. Passed quickly so wasn't concerned and took pseudophendirine at night a couple of time to clear what I thought was simply sinus congestion. I had a knee inflamation due to osteo arthritis on 1 Jan and had taken a 5-d course of Prednisone beginning 1 Jan. Infmamation subsided and not further prednisone was taken between 6 and 22 Jan.,"Typical 70-y old aches and pains, but none others. I have had very slight lateral benign vertigo off and on for about a year or so, but none in the last 6 months except the episodes described above.",,None,"['Balance disorder', 'Blood test normal', 'Computerised tomogram normal', 'Condition aggravated', 'Deafness unilateral', 'Disturbance in attention', 'Dizziness', 'Ear discomfort', 'Fear', 'Feeling cold', 'Gait disturbance', 'Hyperventilation', 'Incoherent', 'Magnetic resonance imaging normal', 'Nausea', 'Pain in extremity', 'Paraesthesia', 'Sudden hearing loss', 'Tinnitus', 'Vertigo', 'Vision blurred']",1,PFIZER\BIONTECH,IM 992400,AL,58.0,F,"Idiopathic thrombocytopenia Onset Jan 27; platelets dropped to <3000. Good response to decadron with rise to 100,000 by feb 1. No significant bleeding",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/27/2021,7.0,PVT,None,None,None,,Wasps,"['Immune thrombocytopenia', 'Platelet count decreased']",2,PFIZER\BIONTECH,IM 992414,TX,52.0,F,"Patient received FluBlok Vaccine on December 28th 2020, patient called pharmacy on January 4th 2021 stating that she was experiencing pain and movement difficulties at the site of injection. During that first complaint patient was advised by pharmacist to follow up with primary care doctor if pain did not imporve with in the next 2 days. Patient called back the following week and informed that pain had increased and mobility was limited. At that point, patient was instructed to schedule an appointment with doctor. Patient saw Doctor on 01/18/21, of which reccommended she see a orthopedic doctor. During her visit with PCP, patient was prescribed Etodolac 400mg and Norco 7.5/325 for pain. Patient was then scheduled to see a a specialist on 01/28/2021. The orthopedic specialist diagnosed patient with Left Subacromial bursitis/Rotator Cuff Tendinitis. At orthopedic clinic, patient received a left shoulder subacromial injection ( 4 ccRopivacaine and 2cc of Kenalog-10)",Not Reported,,Not Reported,Not Reported,,Yes,N,12/28/2020,01/04/2021,7.0,PHM,Armour Thyroid 60mg Losartan Potassium 25 mg Topiramate 25mg amphetamine Salts 30mg,none,Hypertension migrains,,egg allergy and maple syrup,"['Bursitis', 'Injected limb mobility decreased', 'Injection site pain', 'Joint range of motion measurement', 'Rotator cuff syndrome', 'Vaccination site movement impairment']",1,PROTEIN SCIENCES CORPORATION,IM 992428,KY,87.0,F,profound dizziness and nausea leading to hospital admission,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/28/2021,01/29/2021,1.0,PUB,Eliquis 5 mg q12h Atorvastatin 40 mg qday metoprolol tartrate 100 mg q12h,LMCA CVA 22 PAF last June,HTN,,"sulfa, valsartan/hctz","['Dizziness', 'Magnetic resonance imaging', 'Nausea']",1,PFIZER\BIONTECH,IM 992463,TX,21.0,F,"On 1/31, 4 days after vaccine she developed left-sided chest pain described as pressure radiating to left arm. In ED, troponin was elevated and she had emergent left heart catheterization. LHC found normal coronaries and she was discharged home.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/27/2021,01/31/2021,4.0,PVT,Trazodone,,Anxiety,,NKDA,"['Catheterisation cardiac normal', 'Chest discomfort', 'Chest pain', 'Pain', 'Troponin increased']",2,MODERNA,IM 992506,TX,22.0,M,"pt developed fever 102, chills and body aches evening of vaccine. Mon am (2/1/2021) awoke with chest pain. Came to ED for evaluation, diffuse ST elevation in all leads, troponin elevated 4.1, 2nd trop 33. echocardiogram with EF 50% pt currently being worked up for pericarditis, ACS with plans for heart cath in am",Not Reported,,Yes,Yes,,Not Reported,U,01/30/2021,01/30/2021,0.0,PUB,none,none,none,,none,"['Acute coronary syndrome', 'Chest pain', 'Chills', 'Echocardiogram', 'Ejection fraction', 'Electrocardiogram ST segment elevation', 'Pain', 'Pericarditis', 'Pyrexia', 'Troponin increased']",2,MODERNA,SYR 992571,PA,75.0,M,"Patient's wife called the physician's office with increasing SOB. MD advised that the patient go to the ED. While dressing, the patient became unresponsive, 911 called. Patient expired in ED.",Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,PVT,unknown,He stated he was experiencing some shortness of breath with cold and walking up the steps. The patient did report that they had some bloody stool early in the week but that had resolved.,"PMH: DM, HTN, Obesity, hyperlipidemia, Chronic kidney Disease, polyp?s removal. History of Angioedema secondary Ace Inhibitor",,ACE inhibitor,"['Condition aggravated', 'Death', 'Dyspnoea', 'Unresponsive to stimuli']",1,MODERNA,IM 992599,CA,87.0,F,right arm redness,Yes,01/03/2021,Yes,Not Reported,,Not Reported,N,12/31/2020,01/03/2021,3.0,SEN,Lactobacillus Capsule MULTIVITAMINS TABLET CRANBERRY TABLET,COVID-19 POSITIVE 12/14/20,"COPD, DM TYPE 2, CHF, GERD, HYPERTENSION, HYPERLIPIDEMIA",,"Ciprofloxacin, Codeine, Bactrim, Lactose Intolerant",['Erythema'],1,PFIZER\BIONTECH,IM 992603,MD,88.0,M,"Had vaccine on 1/18. No reported fevers or change in functional status/fatigue. Patient appeared in usual state of health. Is ambulatory with rollator. No prior h/o DVT. Was found in bathroom after presumed fall on 1/27. When attempted to lift patient become hypotensive (40-60 systolic). hypoxic (PO would not read). Was placed on 10 L oxygen without PO reading. Sent to ED-required 15 L nonrebreather to get PO into 90s. Was diagnosed with large bilateral PEs. Found to have dvt RLE. Patient was hospitalized 4 days. His covid test was negative. He returned to facility without oxygen, on Eliquis.",Not Reported,,Yes,Yes,4.0,Not Reported,Y,01/18/2021,01/27/2021,9.0,SEN,"zyrtec, lyrica,flomax, B12",none,"dementia, BPH, OA, a fib",,none,"['Angiogram', 'Deep vein thrombosis', 'Fall', 'Fatigue', 'Hypotension', 'Hypoxia', 'Pulmonary embolism', 'Pyrexia', 'Ultrasound Doppler']",UNK,PFIZER\BIONTECH, 992642,MN,75.0,M,"Increased hand and arm tremors, Elevated FSBG (>500) Nausea, decreased mobility, increased confusion, sore throat with Inability to eat or drink",Not Reported,,Yes,Yes,5.0,Not Reported,N,01/25/2021,01/26/2021,1.0,SEN,"EC ASA 81, Tylenol ES, Atorvastatin, Carbadopa - Levodopa, Magnesium, Vitamin D, Senna, Jardiance, Metformin, Lantus Insulin.",,"Alzheimer's Lewy Body Dementia, Parkinson's, Psychotic D/O with hallucinations, CKD, DM2, HDL, Hypomagneseima.",,PCN,"['Blood glucose increased', 'Confusional state', 'Feeding disorder', 'Fluid intake reduced', 'Mobility decreased', 'Nausea', 'Oropharyngeal pain', 'Tremor']",2,MODERNA,IM 992676,TX,30.0,F,"I exclusively nurse my 2 month old baby and on Wednesday morning my son began to have hematemesis and coffee ground stool. He had it the morning of 1/20 and then again he spit up Frank red blood early morning of 1/21 and darkening stools. He continued to have hematemesis sporadically until midnight 1/21 when he stopped eating and went NPO. We took him to the ER per our pediatrician?s advice around 1pm on 1/21 and stayed overnight to do an endoscopy in the morning. His CBC and PTT were normal and the endoscopy showed stomach ulcers had developed. Biopsies were taken and culture for H. Pylori sent . Biopsies showed no pathology and h.pylori did not grow on culture. Currently, I have no explanation for his stomach ulcer development and I feel that the close proximity to my first vaccination should be further evaluated.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/18/2021,01/20/2021,2.0,PVT,Prenatal vitamin,None,None,,None,"['Activated partial thromboplastin time normal', 'Biopsy oesophagus normal', 'Biopsy small intestine normal', 'Biopsy stomach', 'Decreased appetite', 'Endoscopy abnormal', 'Exposure via breast milk', 'Faeces discoloured', 'Full blood count normal', 'Gastric ulcer', 'Gastrointestinal haemorrhage', 'Haematemesis', 'Helicobacter test negative', 'Infantile spitting up', 'Occult blood']",1,MODERNA,IM 992677,MN,64.0,M,"Low Grade Temp, Persistent low back pain, Projectile Vomiting.",Yes,01/29/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,SEN,"Clonazepam, Mirtazapine, Seroquel, Austedo, Risperdal, Senna, Omeprazole",,"Huntington's Anxiety, Depression, Constipation.",,Paroxetine,"['Back pain', 'Body temperature increased', 'Vomiting projectile']",2,MODERNA,IM 992734,KY,86.0,F,"1st COVID immunization 1/7/2021, COIVD positive results on 1/16/21, 1/24/21 O2 sats decreased to 78%, 1/24/21 reveived the Bamlanivimab infusion 50 ml/hr. 1/24/20 chest x ray 1/24/21 She was sent to hospital and admitted. 1/27/2021 Expired",Yes,01/27/2021,Not Reported,Yes,3.0,Not Reported,N,01/07/2021,01/24/2021,17.0,SEN,alendronate sodium 70 mg 1 time a day every sunday for arthritis aspirin 81 mg q day Buspirone HCL 5 mg 3 times daily Calcitonin solution 200 units 1 spray via nostril Calcium capsule 250 mg 2 times per day Cardedilol 6.25 tab 2 times per,"Rheumatoid Arthritis, overactive bladder, glaucoma, major depressive disorder, Alzheimers Disease, polyneuropathy,","Rheumatoid Arthritis, overactive bladder, glaucoma, major depressive disorder, Alzheimers Disease, polyneuropathy,",,"codeine, penicillin, enbrel, septra, sulfa antibiotics","['Chest X-ray', 'Death', 'Oxygen saturation decreased', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 992762,FL,95.0,F,Basal Ganglia Stroke,Not Reported,,Not Reported,Yes,4.0,Yes,N,01/22/2021,01/25/2021,3.0,OTH,None!,none,none,,none,['Basal ganglia stroke'],UNK,PFIZER\BIONTECH, 992774,CO,92.0,M,"On 1/20/2021 the resident experienced hypotension while at dialysis and was not able to complete treatment prior to being transferred to the hospital. He also had congestion in lungs. The hospital notes indicate upon admission to the hospital he was being treated for # Shock - distributive - cover for sepsis, check u/s RLE, possible SIRS response after second COVID vaccine. MAP >55 and # ESRD. While in the hospital resident was treated for hypotension, right lower leg cellulitis and the rate of pacemaker was increased.",Not Reported,,Not Reported,Yes,8.0,Not Reported,Y,01/19/2021,01/20/2021,1.0,SEN,"Aspirin Tablet 81 MG, Clopidogrel Bisulfate Tablet 75 MG, Colace Capsule 100 MG, Darbepoetin Alfa Solution Prefilled Syringe 25 MCG/0.42ML, Glucosamine-Chondroit-Vit C-Mn Tablet, Levothyroxine Sodium Tablet 88 MCG, Lyrica Capsule 50 MG, Mel",Resident is dialysis dependent. Was evaluated by NP for epistaxis in December and was seen in ER and treated with Tranexamic. Resident is oxygen dependent due to COPD. Resident had an unwitnessed fall on 1/9/2021.,"End Stage Renal Disease- dialysis dependent, renal cancer, Atherosclerotic heart disease, Type 2 diabetes, COPD, GERD, Atrial Fibrillation, cardiac pace maker, prostate cancer, history of covid positive -resulting in hospitalization and received convalescent plasma in May, 2020",,"Codeine, Lactose Intolerant, Cats, Pollen","['Atelectasis', 'Cardiac pacemaker adjustment', 'Cellulitis', 'Chest X-ray abnormal', 'Computerised tomogram abdomen', 'Distributive shock', 'Echocardiogram', 'Hypotension', 'Lung consolidation', 'Lung opacity', 'Oedema peripheral', 'Pleural effusion', 'Pulmonary congestion', 'Sepsis']",1,MODERNA,IM 992776,,93.0,M,Moderna COVID-19 Vaccine EUA patient developed acute respiratory failure with bilateral pulmonary infiltrates 1 week after receiving Moderna COVID vaccine,Not Reported,,Yes,Yes,5.0,Not Reported,N,01/20/2021,01/28/2021,8.0,UNK,,,idiopathic pulmonary fibrosis,,,"['Acute respiratory failure', 'Lung infiltration']",1,MODERNA, 992781,FL,66.0,F,"Within 3 hours: Dizziness, severe diarrhea, vomiting, loss of consciousness, rapid shallow breathing, BP 87/40, called 911, went to E.R.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PUB,Metoprolol; Losartan; Clonazepam; Omeprazole; Ibuprofen.,None.,Mitral valve regurgitation; COPD; asthma.,,None.,"['Blood glucose', 'Blood test', 'Diarrhoea', 'Dizziness', 'Electrocardiogram', 'Full blood count', 'Hypopnoea', 'Loss of consciousness', 'Respiratory rate increased', 'Vomiting']",1,PFIZER\BIONTECH,IM 992810,FL,68.0,F,"Concern comes from a pulmonary Embolism and DVT diagnosed within a week of the first shot. Realize this could be a coincidence, I have no history of clots.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/19/2021,01/22/2021,3.0,PUB,,None,"Chronic kidneys, asthma, high blood pressure, hypothyroidism",,,"['Computerised tomogram thorax abnormal', 'Deep vein thrombosis', 'Imaging procedure abnormal', 'Magnetic resonance imaging abnormal', 'Pulmonary embolism']",UNK,PFIZER\BIONTECH, 992836,WA,26.0,M,Presented about 60 hours after 2nd moderna vaccine with crushing chest pain and was found to have acute pericarditis and a troponin of 10.,Not Reported,,Yes,Yes,2.0,Not Reported,U,01/27/2021,01/30/2021,3.0,PVT,Aderell Truvada,Nil,Taking PreP ADHD,,Augmentin Cat Dander,"['Catheterisation cardiac normal', 'Chest discomfort', 'Chest pain', 'Echocardiogram abnormal', 'Ejection fraction normal', 'HIV test negative', 'Hepatitis B antibody negative', 'Hepatitis C antibody negative', 'Pericardial effusion', 'Pericardial fibrosis', 'Pericarditis', 'Respiratory viral panel', 'SARS-CoV-2 test negative', 'Troponin increased']",2,MODERNA, 992846,MT,82.0,M,Patient complained to wife of not feeling well in evening after the vaccination and expired at home during the night.,Yes,01/29/2021,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,PVT,Coreg 12.5 mg tablet: 12.5 mg PO BID; Hytrin 10 mg capsule po daily; Lasix 20 mg tablet po daily; Lipitor 40 mg tablet daily; Phenobarbital 30 mg tablet po BID; Levothyroxine 100 mcg tablet daily; lisinopril 2.5 mg tablet po daily; pantopra,CRT-P upgrade on 1/7/2021 Pacemaker 0107 on 1/7/2021,Acute MI; arthritis; atrial fibrillation; bleeding; bronchitis; bypass; cholecystitis; chronic anemia; COPD; CKD; CAD; Heart block Hypercholesteremia; HTN; hypothyroidism; MI,,CeleBREX-GI Bleed Morphine-urticaria,"['Death', 'Malaise']",1,MODERNA,IM 992848,TX,30.0,F,"Pt is G1P0. EDD was 8/15 by LMP. The patient had an ultrasound on 1/6 showing a live intrauterine pregnancy with crown rump length measuring 8 weeks 0 days. She had covid vaccine 1/7. Came in with vaginal bleeding 1/29 and found to have missed abortion on ultrasound (no heart tones, crown rump length measuring 8 weeks 3 days). Underwent D&C 2/1.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,prenatal vitamins,No,No,,No,"['Abortion missed', 'Ultrasound foetal', 'Ultrasound foetal abnormal', 'Uterine dilation and curettage', 'Vaginal haemorrhage']",1,MODERNA,IM 992853,AZ,69.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Yes,U,,02/01/2021,,PVT,"Tramadol, lyrica, armor, sleep med, cymbalta, vit B, cholesterol, blood med, biotin, bladder med, potassium, gingko.",Na,"Blood pressure, kidney disease, nerve problems, neuropathy, thyroid problems ,",,Sulfa drugs adhesive,"['Computerised tomogram', 'Unevaluable event', 'X-ray']",1,PFIZER\BIONTECH, 992864,MA,87.0,F,"Patient was having shortness of breath, Heart rate was 111, respirations were 44, suctioned multiple times MD notified and sent to Emergency room for evaluation",Not Reported,,Yes,Yes,5.0,Not Reported,U,01/27/2021,01/28/2021,1.0,SEN,Albuterol Sulfate Nebulization Solution (2.5 MG/3ML) 0.083% 1 dose via trach every 4 hours as needed for SOB/Wheezing Resp (Breaths/min) O2 Sats (%) LS (1-Clear 2-Rhonchi 3-Crackles 4-Dim 5-Wheezes) Post (Outcome: I-Improved NC-No change W,"Z43.0 T ENCOUNTER FOR ATTENTION TO TRACHEOSTOMY Medical Management 5/2/2019 Primary Primary Admitting Diagnosis 5/3/2019 update R06.02 SHORTNESS OF BREATH N/A, not an acceptable Primary Diagnosis 1/21/2020 A During Stay 2/7/2020 slopes update M62.81 MUSCLE WEAKNESS (GENERALIZED) N/A, not an acceptable Primary Diagnosis 5/2/2019 B During Stay 5/3/2019 update D64.9 ANEMIA, UNSPECIFIED Medical Management 9/25/2019 C During Stay 9/26/2019 update Z43.1 ENCOUNTER FOR ATTENTION TO GASTROSTOMY Medical Management 5/2/2019 D Admission (Also Present on Admission) 5/3/2019 update R13.10 T DYSPHAGIA, UNSPECIFIED N/A, not an acceptable Primary Diagnosis 5/2/2019 E Admission (Also Present on Admission) 5/7/2019 update I50.9 HEART FAILURE, UNSPECIFIED Cardiovascular and Coagulations 5/2/2019 F Admission (Also Present on Admission) 5/3/2019 update F33.1 MAJOR DEPRESSIVE DISORDER, RECURRENT, MODERATE Medical Management 5/2/2019 I Admission (Also Present on Admission) 5/3/2019 update R49.8 T OTHER VOICE AND RESONANCE DISORDERS N/A, not an acceptable Primary Diagnosis 9/13/2019 J During Stay 9/18/2019 update B96.4 PROTEUS (MIRABILIS) (MORGANII) AS THE CAUSE OF DISEASES CLASSIFIED ELSEWHERE Acute Infections 11/24/2020 K 12/1/2020 update J69.0 PNEUMONITIS DUE TO INHALATION OF FOOD AND VOMIT Pulmonary 4/29/2020 Non-Ranked Diagnosis History 4/29/2020 update J18.9 T PNEUMONIA, UNSPECIFIED ORGANISM Pulmonary 4/28/2020 Non-Ranked Diagnosis History 6/2/2020 slopes update Z20.828 CONTACT WITH AND (SUSPECTED) EXPOSURE TO OTHER VIRAL COMMUNICABLE DISEASES N/A, not an acceptable Primary Diagnosis 4/28/2020 Non-Ranked Diagnosis History 4/29/2020 update J20.8 ACUTE BRONCHITIS DUE TO OTHER SPECIFIED ORGANISMS Tracheobronchitis Pulmonary 10/28/2019 Non-Ranked Diagnosis History 11/8/2019 slopes update R26.89 T OTHER ABNORMALITIES OF GAIT AND MOBILITY N/A, not an acceptable Primary Diagnosis 7/26/2019 Non-Ranked Diagnosis History 7/26/2019 update F43.20 ADJUSTMENT DISORDER, UNSPECIFIED Medical Management 7/11/2019 Non-Ranked Diagnosis During Stay 7/19/2019 slopes update J40 BRONCHITIS, NOT SPECIFIED AS ACUTE OR CHRONIC","Z43.0 T ENCOUNTER FOR ATTENTION TO TRACHEOSTOMY Medical Management 5/2/2019 Primary Primary Admitting Diagnosis 5/3/2019 update R06.02 SHORTNESS OF BREATH N/A, not an acceptable Primary Diagnosis 1/21/2020 A During Stay 2/7/2020 slopes update M62.81 MUSCLE WEAKNESS (GENERALIZED) N/A, not an acceptable Primary Diagnosis 5/2/2019 B During Stay 5/3/2019 update D64.9 ANEMIA, UNSPECIFIED Medical Management 9/25/2019 C During Stay 9/26/2019 update Z43.1 ENCOUNTER FOR ATTENTION TO GASTROSTOMY Medical Management 5/2/2019 D Admission (Also Present on Admission) 5/3/2019 update R13.10 T DYSPHAGIA, UNSPECIFIED N/A, not an acceptable Primary Diagnosis 5/2/2019 E Admission (Also Present on Admission) 5/7/2019 update I50.9 HEART FAILURE, UNSPECIFIED Cardiovascular and Coagulations 5/2/2019 F Admission (Also Present on Admission) 5/3/2019 update F33.1 MAJOR DEPRESSIVE DISORDER, RECURRENT, MODERATE Medical Management 5/2/2019 I Admission (Also Present on Admission) 5/3/2019 update R49.8 T OTHER VOICE AND RESONANCE DISORDERS N/A, not an acceptable Primary Diagnosis 9/13/2019 J During Stay 9/18/2019 update B96.4 PROTEUS (MIRABILIS) (MORGANII) AS THE CAUSE OF DISEASES CLASSIFIED ELSEWHERE Acute Infections 11/24/2020 K 12/1/2020 update J69.0 PNEUMONITIS DUE TO INHALATION OF FOOD AND VOMIT Pulmonary 4/29/2020 Non-Ranked Diagnosis History 4/29/2020 update J18.9 T PNEUMONIA, UNSPECIFIED ORGANISM Pulmonary 4/28/2020 Non-Ranked Diagnosis History 6/2/2020 slopes update Z20.828 CONTACT WITH AND (SUSPECTED) EXPOSURE TO OTHER VIRAL COMMUNICABLE DISEASES N/A, not an acceptable Primary Diagnosis 4/28/2020 Non-Ranked Diagnosis History 4/29/2020 update J20.8 ACUTE BRONCHITIS DUE TO OTHER SPECIFIED ORGANISMS Tracheobronchitis Pulmonary 10/28/2019 Non-Ranked Diagnosis History 11/8/2019 slopes update R26.89 T OTHER ABNORMALITIES OF GAIT AND MOBILITY N/A, not an acceptable Primary Diagnosis 7/26/2019 Non-Ranked Diagnosis History 7/26/2019 update F43.20 ADJUSTMENT DISORDER, UNSPECIFIED Medical Management 7/11/2019 Non-Ranked Diagnosis During Stay 7/19/2019 slopes update J40 BRONCHITIS, NOT SPECIFIED AS ACUTE OR CHRONIC",,NKDA,"['Condition aggravated', 'Device malfunction', 'Dyspnoea']",2,PFIZER\BIONTECH,IM 992878,MN,34.0,F,"LOC, not breathing, admitted to hospital x3 days",Not Reported,,Yes,Yes,3.0,Not Reported,Y,01/18/2021,01/27/2021,9.0,OTH,Diltiazem Unifiber Miralax Acetaminophen Vitamin B6 Nephrovite Sodium Chloride Cranberry Juice Carvedilol Flax Seed Oil Gabapentin Ladin Ceterizine Folic Acid Zinc Fluticanose Sevelamer Aspirin Famotodine Melatonin Clonidine PRN Zofran PRN,,Kidney disease Lipoprotein metabolism disorder Developmental disorder Cerebral palsy Osteoporosis Deaf,,Ceftriaxone Seasonal Allergies Bactrim Adhesives,"['Computerised tomogram', 'Loss of consciousness', 'Respiratory arrest', 'Troponin increased']",1,MODERNA,IM 992882,OH,51.0,M,"Became immediately hot, within 2 hours I was having issues breathing, blood pressure of 202/170. Put on oxygen as my O2 dropped to 90%, Irregular EKG, blood work taken.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,PVT,"Diltiazem, ibuprofen",None,High blood pressure and Concussion syndrome,,None,"['Dyspnoea', 'Electrocardiogram abnormal', 'Feeling hot', 'Immediate post-injection reaction', 'Laboratory test', 'Oxygen saturation decreased']",2,MODERNA,SYR 992884,KS,57.0,F,"The next morning after vaccine, patient ran a fever, vomited, and was very tired. Mom laid her down to sleep and when she checked later, patient had passed away.",Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/17/2021,1.0,PHM,Unknown,Unknown,Unknown,,Sulfa Allergy,"['Death', 'Fatigue', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 992886,MA,80.0,F,"Patient began shaking, had shortness of Breath, Increased heart rate 148, low o2 sat 90 increased temp 99.5 respirations were 38 B/P 144/70 blood sugar 198",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/27/2021,01/28/2021,1.0,SEN,"ARTHRTS PAIN TAB 650MG Give 2 tablet orally at bedtime for PAIN TD=1300 mg, NTE 3gm/24 hr Pharmacy Active 4/9/2019 21:00 4/13/2019 MIRTAZAPINE TAB 45MG Give 0.5 tablet orally in the evening related to MAJOR DEPRESSIVE DISORDER, RECURRENT","J44.9CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED Converted from ICD-9-CM 491.20 OBSTRUCTIVE CHRONIC BRONCHITIS WITHOUT EXACERBAT NTA (2 pts) Pulmonary 12/15/2011 Primary Admission (Also Present on Admission) 6/2/2014 update J18.9 PNEUMONIA, UNSPECIFIED ORGANISM Pulmonary 10/27/2020 A During Stay 10/28/2020 update E11.8 TYPE 2 DIABETES MELLITUS WITH UNSPECIFIED COMPLICATIONS NTA (2 pts) Medical Management 3/5/2017 B Admission (Also Present on Admission) 3/6/2017 update F20.0 PARANOID SCHIZOPHRENIA Medical Management 5/21/2018 C During Stay 6/1/2018 update I50.22 CHRONIC SYSTOLIC (CONGESTIVE) HEART FAILURE Cardiovascular and Coagulations 1/22/2019 D During Stay 4/19/2019 update M62.81 T MUSCLE WEAKNESS (GENERALIZED) N/A, not an acceptable Primary Diagnosis 4/12/2020 E Admission (Also Present on Admission) 4/14/2020 update R26.89 T OTHER ABNORMALITIES OF GAIT AND MOBILITY N/A, not an acceptable Primary Diagnosis 4/12/2020 F Admission (Also Present on Admission) 4/14/2020 update D64.9 ANEMIA, UNSPECIFIED Converted from ICD-9-CM 285.9 UNSPECIFIED ANEMIA Medical Management 12/15/2011 G Admission (Also Present on Admission) 6/2/2014 update I10 ESSENTIAL (PRIMARY) HYPERTENSION Converted from ICD-9-CM 401.9 UNSPECIFIED ESSENTIAL HYPERTENSION N/A, not an acceptable Primary Diagnosis 12/15/2011 H Admission (Also Present on Admission) 6/2/2014 update R13.10 DYSPHAGIA, UNSPECIFIED N/A, not an acceptable Primary Diagnosis 4/12/2020 I Admission (Also Present on Admission) 4/13/2020 update E78.5 HYPERLIPIDEMIA, UNSPECIFIED Medical Management 1/22/2019 J During Stay 4/19/2019 update F32.0 MAJOR DEPRESSIVE DISORDER, SINGLE EPISODE, MILD Medical Management 5/21/2018 K During Stay 6/1/2018 update F34.9 PERSISTENT MOOD [AFFECTIVE] DISORDER, UNSPECIFIED Medical Management 12/18/2018 L During Stay 4/19/2019 update F41.1 GENERALIZED ANXIETY DISORDER Medical Management 5/21/2018 M During Stay 6/1/2018 update F51.01 PRIMARY INSOMNIA Medical Management 5/21/2018 N During Stay 6/1/2018 update I42.9 CARDIOMYOPATHY, UNSPECIFIED Cardiovascular and Coagulations 1/22/2019 O During Stay 4/19/2019 update R26.2 T DIFFICULTY IN WALKING, NOT ELSEWHERE CLASSIFIED N/A, not an acceptable Primary Diagnosis 7/4/2020 S 8/4/2020 update U07.1 T COVID-19 Pulmonary 6/5/2020 Non-Ranked Diagnosis History 6/8/2020 update Z16.12 EXTENDED SPECTRUM BETA LACTAMASE (ESBL) RESISTANCE N/A, not an acceptable Primary Diagnosis 4/12/2020 Non-Ranked Diagnosis History 4/13/2020 update Z87.898 PERSONAL HISTORY OF OTHER SPECIFIED CONDITIONS N/A, not an acceptable Primary Diagnosis 5/21/2018 Non-Ranked Diagnosis During Stay 6/1/2018 update R06.02 SHORTNESS OF BREATH N/A, not an acceptable Primary Diagnosis 9/5/2017 Non-Ranked Diagnosis Admission (Also Present on Admission) 9/5/2017 update Z99.81 DEPENDENCE ON SUPPLEMENTAL OXYGEN N/A, not an acceptable Primary Diagnosis 3/5/2017 Non-Ranked Diagnosis Admission (Also Present on Admission) 3/6/2017 update R13.14 DYSPHAGIA, PHARYNGOESOPHAGEAL PHASE N/A, not an acceptable Primary Diagnosis 7/18/2016 Non-Ranked Diagnosis History 7/19/2016 update K62.3 RECTAL PROLAPSE N/A, not an acceptable Primary Diagnosis 2/26/2016 Non-Ranked Diagnosis History 4/15/2016 update F33.3 MAJOR DEPRESSIVE DISORDER, RECURRENT, SEVERE WITH PSYCHOTIC SYMPTOMS Converted from ICD-9-CM 298.0 DEPRESSIVE TYPE PSYCHOSIS Medical Management 12/15/2011 Non-Ranked Diagnosis Admission (Also Present on Admission) 6/2/2014 update F41.9 ANXIETY DISORDER, UNSPECIFIED Converted from ICD-9-CM 300.00 ANXIETY STATE, UNSPECIFIED Medical Management 12/15/2011 Non-Ranked Diagnosis 11/26/2014 update Z86.16 PERSONAL HISTORY OF COVID-19 N/A, not an acceptable Primary Diagnosis 1/8/2021 1/8/2021 update Z11.52 ENCOUNTER FOR SCREENING FOR COVID-19 N/A, not an acceptable Primary Diagnosis 1/8/2021","J44.9 CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED Converted from ICD-9-CM 491.20 OBSTRUCTIVE CHRONIC BRONCHITIS WITHOUT EXACERBAT NTA (2 pts) Pulmonary 12/15/2011 Primary Admission (Also Present on Admission) 6/2/2014 update J18.9 PNEUMONIA, UNSPECIFIED ORGANISM Pulmonary 10/27/2020 A During Stay 10/28/2020 update E11.8 TYPE 2 DIABETES MELLITUS WITH UNSPECIFIED COMPLICATIONS NTA (2 pts) Medical Management 3/5/2017 B Admission (Also Present on Admission) 3/6/2017 update F20.0 PARANOID SCHIZOPHRENIA Medical Management 5/21/2018 C During Stay 6/1/2018 update I50.22 CHRONIC SYSTOLIC (CONGESTIVE) HEART FAILURE Cardiovascular and Coagulations 1/22/2019 D During Stay 4/19/2019 update M62.81 T MUSCLE WEAKNESS (GENERALIZED) N/A, not an acceptable Primary Diagnosis 4/12/2020 E Admission (Also Present on Admission) 4/14/2020 update R26.89 T OTHER ABNORMALITIES OF GAIT AND MOBILITY N/A, not an acceptable Primary Diagnosis 4/12/2020 F Admission (Also Present on Admission) 4/14/2020 update D64.9 ANEMIA, UNSPECIFIED Converted from ICD-9-CM 285.9 UNSPECIFIED ANEMIA Medical Management 12/15/2011 G Admission (Also Present on Admission) 6/2/2014 update I10 ESSENTIAL (PRIMARY) HYPERTENSION Converted from ICD-9-CM 401.9 UNSPECIFIED ESSENTIAL HYPERTENSION N/A, not an acceptable Primary Diagnosis 12/15/2011 H Admission (Also Present on Admission) 6/2/2014 update R13.10 DYSPHAGIA, UNSPECIFIED N/A, not an acceptable Primary Diagnosis 4/12/2020 I Admission (Also Present on Admission) 4/13/2020 update E78.5 HYPERLIPIDEMIA, UNSPECIFIED Medical Management 1/22/2019 J During Stay 4/19/2019 slopes update F32.0 MAJOR DEPRESSIVE DISORDER, SINGLE EPISODE, MILD Medical Management 5/21/2018 K During Stay 6/1/2018 update F34.9 PERSISTENT MOOD [AFFECTIVE] DISORDER, UNSPECIFIED Medical Management 12/18/2018 L During Stay 4/19/2019 update F41.1 GENERALIZED ANXIETY DISORDER Medical Management 5/21/2018 M During Stay 6/1/2018 update F51.01 PRIMARY INSOMNIA Medical Management 5/21/2018 N During Stay 6/1/2018 update I42.9 CARDIOMYOPATHY, UNSPECIFIED Cardiovascular and Coagulations 1/22/2019 O During Stay 4/19/2019 update R26.2 T DIFFICULTY IN WALKING, NOT ELSEWHERE CLASSIFIED N/A, not an acceptable Primary Diagnosis 7/4/2020 S 8/4/2020 update U07.1 T COVID-19 Pulmonary 6/5/2020 Non-Ranked Diagnosis History 6/8/2020 update Z16.12 EXTENDED SPECTRUM BETA LACTAMASE (ESBL) RESISTANCE N/A, not an acceptable Primary Diagnosis 4/12/2020 Non-Ranked Diagnosis History 4/13/2020 update Z87.898 PERSONAL HISTORY OF OTHER SPECIFIED CONDITIONS N/A, not an acceptable Primary Diagnosis 5/21/2018 Non-Ranked Diagnosis During Stay 6/1/2018 update R06.02 SHORTNESS OF BREATH N/A, not an acceptable Primary Diagnosis 9/5/2017 Non-Ranked Diagnosis Admission (Also Present on Admission) 9/5/2017 update Z99.81 DEPENDENCE ON SUPPLEMENTAL OXYGEN N/A, not an acceptable Primary Diagnosis 3/5/2017 Non-Ranked Diagnosis Admission (Also Present on Admission) 3/6/2017 update R13.14 DYSPHAGIA, PHARYNGOESOPHAGEAL PHASE N/A, not an acceptable Primary Diagnosis 7/18/2016 Non-Ranked Diagnosis History 7/19/2016 update K62.3 RECTAL PROLAPSE N/A, not an acceptable Primary Diagnosis 2/26/2016 Non-Ranked Diagnosis History 4/15/2016 update F33.3 MAJOR DEPRESSIVE DISORDER, RECURRENT, SEVERE WITH PSYCHOTIC SYMPTOMS Converted from ICD-9-CM 298.0 DEPRESSIVE TYPE PSYCHOSIS Medical Management 12/15/2011 Non-Ranked Diagnosis Admission (Also Present on Admission) 6/2/2014 update F41.9 ANXIETY DISORDER, UNSPECIFIED Converted from ICD-9-CM 300.00 ANXIETY STATE, UNSPECIFIED Medical Management 12/15/2011 Non-Ranked Diagnosis 11/26/2014 update Z86.16 PERSONAL HISTORY OF COVID-19 N/A, not an acceptable Primary Diagnosis 1/8/2021 1/8/2021 update Z11.52 ENCOUNTER FOR SCREENING FOR COVID-19 N/A, not an acceptable Primary Diagnosis 1/8/2021",,NKA,"['Blood glucose increased', 'Body temperature increased', 'Dyspnoea', 'Heart rate increased', 'Oxygen saturation decreased', 'Tremor']",2,PFIZER\BIONTECH,IM 992900,SD,52.0,F,"Anaphylaxis, tongue swelling, difficulty breathing, & hives, Ambulance transported pt to the nearest ER, required Epinephrine injections 1mg IM X3, IV Methylprednisolone 50mg and IV Benadryl 50mg, pt had to be transferred to higher level of care due to ongoing symptoms and was kept until 1/24/21. Pt said staff at the ER told her they knew they should report the reaction to someone but didn't know how to report it.",Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/20/2021,01/22/2021,2.0,PVT,"Glipizide, ASA, Crestor, & B12",None,Diabetes,,Voltaren,"['Anaphylactic reaction', 'Dyspnoea', 'Swollen tongue', 'Urticaria']",1,PFIZER\BIONTECH,IM 992902,CA,58.0,F,"chest tightness, shortness of breath, then went to throat sore throat, hoarseness patient received EPIPEN 0.3 mg 3 doses 5 min apart. then went to ER had two breathing treatments, albuterol, epinephrine, solumedrol one injection, 50 mg Benadryl reports rash at IV site from (Benadryl?) No rash anywhere else. Prednisone tapering dose and Benadryl 50 mg at night and 25 during day time. To follow up with PMD. Headache.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,OTH,"lisinopril, Prilosec, gabapentin, Norco amlodipine",mild itchiness after first dose one,"blood pressure, diabetes type 2, asthma, chronic pain , severe allergies, post op bariatric, chronic low backpain, chronic pain, retinopathy, elevated tranaminases, fatty liver disease, GAD, hx hysterectomy/menopause , hyperlipidemia, incarcerated abd hernia, incisional hernia, paresthesia, mild pers asthma controlled, obesity, obstructive sleep apnea, osteoarthritis b/l knees. hx of SVT, patellofemoral syndrome",,"latex, clindamycin, penicillin, Macrobid.","['Blood test', 'Chest X-ray', 'Chest discomfort', 'Dysphonia', 'Dyspnoea', 'Electrocardiogram', 'Headache', 'Oropharyngeal pain', 'Rash']",2,PFIZER\BIONTECH,IM 992915,FL,56.0,F,"Severe, unprovoked, sudden onset nausea followed by severe chest pain, diaphoresis, shortness of breath and excessive salivation., with no prior cardiac history. EMS was called, I was placed on a Life Pack Monitor. ECG was borderline. Advised to go to hospital. Enroute to hospital, 20g Angio IV in right AC was established. Administered 4 Baby Aspirin and 1 Nitroglycerine. Nitroglycerine relieved chest pain. At hospital labs were ordered. CMP, CBC and Triponin were normal. Advised by physician to remain for monitoring overnight and further Triponin testing. On 01/11/2021, I had a Stress Test and Echocardiogram. Stress Test showed areas of ischemia. On 01/12/2021 I had a Cardiac Cath through my right wrist. Results were negative. Discharged to home from hospital with follow up appt with Cardiologist scheduled. Every person that I came into contact with was informed that I had had the Moderna Vaccine 7 hours prior to onset of symptoms.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/10/2020,01/10/2020,0.0,PVT,Levothyroxine,None,Hashimoto's Thyroid Fibromyalgia,,"NKDA, NKA","['Cardiac stress test abnormal', 'Chest pain', 'Dyspnoea', 'Echocardiogram', 'Full blood count', 'Hyperhidrosis', 'Ischaemia', 'Metabolic function test', 'Nausea', 'Salivary hypersecretion', 'Troponin']",1,MODERNA,IM 992936,RI,31.0,F,Appendicitis resulting in emergency removal of appendix,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/30/2021,01/31/2021,1.0,PHM,Prenatal vitamins,None,None,,None,"['Appendicectomy', 'Appendicitis', 'Computerised tomogram abnormal']",UNK,MODERNA, 992977,OH,84.0,F,"spoke with patient husband on Saturday 1/23 and he said that she had been in the hospital. that she had had a stroke, the MD's at the hospital told him that it was not contributed to the vaccine and that they were unsure even if the stroke had occurred prior to the vaccine or after. spoke with him again on 1-29 and he stated that she had passed away on 1/25/21",Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,PHM,"pantoprazole, tramadol, duloxetine, vesicare",unsure,unsure,,"cephalosporins, sulfa, penicillins, opiods,","['Cerebrovascular accident', 'Death']",1,MODERNA,IM 992985,WA,66.0,F,"Sunday: tightness in chest Monday : short of breath with walking Tuesday: extreme shortness of breath Wednesday: continued worsening SOB- sent for labs/ chest xray Thursday: D-dimer back -4.53- sent to hospital CAT scan showed multiple pulmonary embolisms without cor pulmonale / ultrasound- multiple DVTs, hospitalized 01-21 to 01-23/ heparin drip, transitioned to apixiban Discharged home",Not Reported,,Yes,Yes,3.0,Not Reported,N,01/15/2021,01/17/2021,2.0,SEN,simvastatin 20 mg PO daily Metoprolol Succinate 100 mg PO daily Centrum Silver- one tablet daily aspirin 81 mg PO daily Magnesium oxide 400 mg po bid,none,"Hypertension, Hyperlipidemia- LDL- 97, HDL-52, Triglycerides 143- Well managed",,NKDA/ No food allergies of any kind,"['Chest X-ray', 'Chest discomfort', 'Computerised tomogram abnormal', 'Deep vein thrombosis', 'Dyspnoea', 'Fibrin D dimer increased', 'Laboratory test', 'Pulmonary embolism', 'Ultrasound scan abnormal']",1,PFIZER\BIONTECH,IM 992997,TX,36.0,F,"Nausea Flu like symptoms- aches, chills, fatigue SEVERE RASH- all over body- red and inflamed ITCHY- uncomfortable ER VISIT - Hospitalized Medicine- Prednisone, Zyrtec, Pepcid",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/27/2021,01/27/2021,0.0,PVT,Humalog Insulin (w insulin pump) Rituxan IV -started November For infected finger (10 day round- on 8th day at start of rash) Meloxicam 7.5mg Clindamycin HCL 300mg Sulfamethoxazole -TMP DS,Wound on Right hand- index finger- not healing,Rheumatoid Arthritis Type 1 Diabetes Interstitial Lung Disease Raynaudes,,None,"['Chills', 'Dermatitis', 'Fatigue', 'Influenza like illness', 'Nausea', 'Pain', 'Pruritus', 'Rash', 'Rash erythematous']",1,PFIZER\BIONTECH,SYR 993002,WA,41.0,F,"12/18/20: I recieved first dose Covid vaccine, 12/20/20: developed blurry vision, diminished color, altered depth perception, light sensitivity in right eye, 12/21/20: exam by opthalmologist (Dr), 12/23/20: MRI with and without contrast: showed active inflammation on right optic nerve, optic neuritis - referred to neuro opthalmologist, 12/29/20: examined by Dr. (neuro-opthalmologist), confirmed optic neuritis and referred to Dr. (neurologist) for further eval of possible MS, 01/18/21: virtual meeting with Dr., labs ordered. 02/01/21: no treatment to date and I am still experiencing all original symptoms, though have slightly improved since initial onset. Planned follow up with Dr. (neurologist) this week and follow up with Dr. (neuro-ophthalmologist) next week",Not Reported,,Not Reported,Not Reported,,Yes,N,12/18/2020,12/20/2020,2.0,PVT,"Vitamin D, Vitamin C",no,intermittent mild asthma,frozen shoulder for months after misplaced flu vaccine in 2010,"Sulfa meds, latex, dermabond (skin glue)","['Altered visual depth perception', 'Antinuclear antibody', 'Blood test', 'Dyschromatopsia', 'Full blood count', 'Immunology test', 'Magnetic resonance imaging', 'Metabolic function test', 'Neurological examination', 'Ophthalmic scan', 'Ophthalmological examination', 'Optic neuritis', 'Photophobia', 'Scan with contrast abnormal', 'Treponema test', 'Vision blurred', 'Visual field tests', 'Vitamin B12', 'Vitamin D']",1,PFIZER\BIONTECH,IM 993028,KY,78.0,F,"On 1/9/21-Diaphoresis, O2 90%, respirations 22, increased weakness, wheezing bilaterally. Send to ER for evaluation and treatment. She was sent to ER, where she was admitted for 2 days, then expired there on 1/11/21",Yes,01/11/2021,Not Reported,Yes,2.0,Not Reported,N,01/06/2021,01/09/2021,3.0,SEN,see attached med list,C-diff,"COPD, HTN, DM II, CAD, Acute kidney failure, CHF, GERD, Adult failure to thrive,",,"metoprolol, demerol","['Asthenia', 'Death', 'Hyperhidrosis', 'Wheezing']",1,PFIZER\BIONTECH,IM 993048,NV,25.0,M,"Patient received his 2nd dose of the Moderna vaccine prior to hospital admission at unknown site. Patient reported generalized body aches and that his whole body hurts and feels likes he's ""being poked with a knife."" He endorsed associated symptoms of fever, nausea, back pain, and shortness of breath. The patient denies any sore throat, headache, cough, or vomiting. His back pain is at the tip of his shoulders, in the middle of his spine, and near his kidneys. The patient adds the abdominal pain is worst in the lower left quadrant. Patient admitted for bilateral lower extremity weakness limiting him to ambulate and to rule out Guillain-Barr�. During admission, had fevers, photophobia, phonophobia, and nuchal rigidity. On physical examination patient was able to minimally wiggle toes, had no plantar/dorsiflexion, unable to move hip joints or knee joints bilaterally, lift his legs against gravity.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/26/2021,01/27/2021,1.0,PVT,"Montelukast, rizatriptan, topiramate",,COPD and migraines,,None,"['Abdominal pain', 'Abdominal pain lower', 'Back pain', 'Blood culture negative', 'C-reactive protein normal', 'CSF culture negative', 'CSF test normal', 'Culture negative', 'Culture urine negative', 'Dyspnoea', 'Feeling abnormal', 'Hypokinesia', 'Intervertebral disc protrusion', 'Joint effusion', 'Lumbar puncture normal', 'Magnetic resonance imaging spinal abnormal', 'Mobility decreased', 'Muscular weakness', 'Nausea', 'Nuchal rigidity', 'Pain', 'Phonophobia', 'Photophobia', 'Physical examination abnormal', 'Pyrexia', 'Staphylococcus test negative', 'Vitamin D deficiency']",2,MODERNA,IM 993055,TX,61.0,M,"Patient reports known onset of right foot drop the following day of vaccination (time unknown, reported ""Evening time""). Currently being worked up in the clinic, but now patient is day 12 of foot drop without any significant improvement. Unsure if vaccine reaction, reporting out of caution. Patient has no recent trauma or injury to spine. Signs/Symptoms: Weakness in Dorsiflexion/Eversion of right foot, Mild weakness of right hip extension, Decreased sensation to right lateral lower leg, steppage gait",Not Reported,,Not Reported,Not Reported,,Yes,N,01/20/2021,01/21/2021,1.0,PVT,"metformin, Wellbutrin, Flomax, protonix, crestor, tylenol",no acute illness reported,HLD BPH Pre-Diabetes (A1c 5.8 in Dec 2020) GERD,,,"['Asthenia', 'C-reactive protein normal', 'Foot deformity', 'Gait disturbance', 'Hypoaesthesia', 'Hyporeflexia', 'Metabolic function test', 'Metabolic function test normal', 'Peroneal nerve palsy', 'Red blood cell sedimentation rate normal', 'Sensory loss', 'Spinal X-ray abnormal', 'Spinal deformity', 'Spinal osteoarthritis', 'Spinal retrolisthesis', 'Vitamin B12 normal']",2,MODERNA,IM 993072,MN,64.0,F,Pt. presented to the ER with abd pain and septic shock. Pt. reported to feel ill shortly after receiving the vaccine.,Yes,01/31/2021,Not Reported,Yes,2.0,Not Reported,N,01/27/2021,01/27/2021,0.0,PUB,"Metoprolol, Lipitor, Lisinopril, Asa,Demedex, Levimir, Jardiance, Metformin",None reported,"Type 2 DM, MGUS, Cardiomyopathy with implanted Defib, Chronic heart failure",,Environmental and Magnesium succinate,"['Abdominal pain', 'Ascites', 'Blood alkaline phosphatase increased', 'Blood chloride decreased', 'Blood creatinine increased', 'Blood culture positive', 'Blood lactic acid increased', 'Blood potassium decreased', 'Blood sodium decreased', 'C-reactive protein increased', 'Carbon dioxide decreased', 'Death', 'Malaise', 'Omental necrosis', 'Ovarian necrosis', 'Peritoneal lavage', 'Platelet count decreased', 'Septic shock', 'Streptococcus test positive', 'Surgery', 'White blood cell count decreased']",UNK,MODERNA,SYR 993112,CA,62.0,F,"she was injected, sh stopped eating and talking, the doctor watched her for 2 days. had her transported to the hospital. i was told she had tested positive for COVID 2 times once at the home and once at the hospital. with in 2 DAYS at the hospital she wa on a ventilator 2 days later she died. i talked with the rehab center and confirmed she tested negative for COVID on Dec 27th 2020 and was given the Vaccine on the 29th Dec 202 was in the hospital 4 day later, was on a ventilator 4 days after that then died a few day later as her heart stopped beating. all the while i had POA and was not contacted by Hospital staff until after they had made the next step.",Yes,02/01/2021,Yes,Yes,9.0,Not Reported,N,12/01/2020,01/01/2021,31.0,SEN,"Aspirin ec 81mg, xarelto 20 mg, propranolol 40 mg, Vita-B1 100mg Trazodone 50mg, Clonidine HCL 0.1 mg tablet, Divalproex 80D DR 25mg, CHLORPROMAZINE 10mg, folic acid 1 mg ,Benztropine mes 1mg, cetirizine HCL 10mg, SPIriva 18 MCG CP-handihal",Broken ankle,"Mid intellectual Disabilities, Schizoaffective Disorders, Obesity, Unspecified Heart Disease, Unspecified Hypothyroidism, unspecified Allergic rhinitis",,"PCN,Lactose Intol","['Aphasia', 'Cardiac arrest', 'Death', 'Decreased appetite', 'Dependence on respirator', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,SYR 995147,,88.0,M,"Death Narrative: Patient received the first COVID-19 dose on 12/23. Afterwards, patient complained of localized pain on L deltoid area where the vaccine was administered; his temperature was 98.1 F. On 12/26-27, staff reported that patient appeared more fatigued than usual and was shivering on 12/27, which seized after blanket was given. On 12/28, patient presented with fever (Tmax 100.2 F) and acetaminophen was administered for alleviation of fever. ADR was reported for the fever on 12/29. Patient continued to decline and was placed back on hospice care on 12/29; on 12/30. the symptoms reported on nursing note include erythema and pain on whole L arm. Lidocaine was applied. Patient's family and provider mutually agreed not to administer the second dose of vaccine. He continued to decline and was started on end-of-life care around 1/4 and passed on 1/20 1417.",Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/20/2021,28.0,OTH,,,,,,"['Chills', 'Death', 'Erythema', 'Fatigue', 'General physical health deterioration', 'Injection site pain', 'Laboratory test normal', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 995165,GA,92.0,F,Died in sleep,Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,,01/27/2021,01/30/2021,3.0,PUB,,,,,,['Death'],1,PFIZER\BIONTECH,IM 995168,MI,87.0,F,Aphasia CVA Rhythm IRRegulaR (CardovasculaR) ElEvated Troponin,Not Reported,,Yes,Yes,3.0,Not Reported,,01/21/2021,01/22/2021,1.0,UNK,,Pt.,,,NKDA,"['Aphasia', 'Arrhythmia', 'Cerebrovascular accident', 'Troponin increased']",UNK,PFIZER\BIONTECH, 997081,WI,91.0,F,"Pt suffered stroke on 1-23-21, 2 days after getting vaccine.",Not Reported,,Yes,Not Reported,,Not Reported,U,01/21/2021,01/23/2021,2.0,OTH,unk,unk,unk,,,['Cerebrovascular accident'],1,MODERNA,IM 993117,UT,30.0,F,"Redness, slight swelling, and itchiness at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/30/2021,01/30/2021,0.0,OTH,None,None,None,,Nka,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",UNK,PFIZER\BIONTECH, 993118,CA,46.0,F,"about 8-9 days after, I developed a large red, itchy welt on my arm below injection site, which lasted about 2-3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/16/2021,8.0,PVT,,,fibromyalgia,,,"['Erythema', 'Pruritus', 'Urticaria']",1,MODERNA,IM 993119,UT,42.0,M,"About 1:15 pm (an hour after shot), I was driving and noticed my face on both sides of my temples started to swell. I removed my sunglasses and noticed the swelling for about 20 minutes then it subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,PUB,Omeprazole 20 mg/day Testosterone cream 1 G/day,None,None,,Dairy,['Swelling face'],UNK,MODERNA,SYR 993120,CA,26.0,F,At 20 minutes s/p vaccination deltoid became extremely sore . At 2 hours s/p vaccination i became feverish. At 10 hours s/p vaccination I became nauseous and developed a severe headache.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/01/2021,02/01/2021,0.0,WRK,Prozac 60mg,,Depression/bulimia nervosa,,Ondansteron,"['Headache', 'Injection site pain', 'Nausea', 'Pyrexia']",2,MODERNA, 993121,NM,68.0,F,"Red, itchy rash on right arm above elbow for last three days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/30/2021,7.0,OTH,"Estrogen/Methyltest, Famvir, Lexapro, Allegra, Calcium, Tumeric, Align, Prilosec",None,,,"Penicillin, Latex","['Pruritus', 'Rash erythematous']",1,MODERNA,SYR 993122,NY,41.0,F,"Started from 1/30 Saturday, my left hand fingers started getting numb, 1/31 Sunday the numbness expended to half of the left hand palm, 2/1 Monday the numbness spreads to lower arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/28/2021,01/28/2021,0.0,UNK,Multivitamin,,,,Macrobid,['Hypoaesthesia'],1,MODERNA,SYR 993123,MD,38.0,F,"Pain and redness at injection site. Redness initially size of a quarter on day 1, 11 hrs after injection and increased to the size of a silver dollar on day 2.5. Remained silver dollar size through day 5. Also swelling of arm 2 inches above injection site through it to 2 inches below. Warm to touch. Itchy near injection all lasting 5 days. Symptoms subsided by day 5. Treatment: Tylenol and Benadryl which were ineffective.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,WRK,"Labetalol, Metformin, Vitamin D3, Vitamin C, Iron, Cabergolin, Chlorthalidone, Amlodipine, Claritin, Montelukast, Rabeprazole, Pregabalin, Prazosin, Spironolactone","Fatigue, Chills, Body Ache","HTN, Fibromyalgia, Asthma, Anxiety, Depression, PTSD, Chronic Fatigue, Microademnoma, PCOS",,"Latex, Peanuts, Percocet, Neurontin, Ferrlecit,","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Peripheral swelling']",2,PFIZER\BIONTECH,IM 993124,ID,63.0,F,"Swelling, redness, hot to the touch, itchiness, 3"" x 4""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/01/2021,5.0,WRK,,,,,,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA, 993125,CA,48.0,F,About 15 hours after I felt like I was going to faint This only lasted forabout 5mins and went away but then after that I started to have a fever that rose to 103.9. That fever slowly rose through the day. At that level I took Tylenol. And when it had not gone down after one hour I took Advil. After about 45 minutes later the fever went down. Next day woke up with only a slight fever of 99.6 and felt fine but wanted to share the information none the less. I did not seek medical help.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/31/2021,1.0,OTH,Vitamin C morning of vaccination.,Not ill.,High blood pressure.,,No confirmed allergies.,"['Dizziness', 'Pyrexia']",UNK,MODERNA,IM 993126,TX,32.0,F,"Date of vaccine - foot, legs, arm, hand tingling. Intermittently since then including today nearly 3 weeks out, most prominent in left arm and hand. Has caused significant anxiety.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,PVT,"Flonase, Zyrtec, allergan eye drops",None,None,,None,"['Anxiety', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 993127,CA,41.0,M,"Jan 22, 2021 - 7:00pm - My housemates have notice my left mouth was barely moving when I speak. But dismissed it and didn't inform me. I personally did not notice it as at this time I have experience chills and my temperature rose to about 100.4 F Jan 24, 2021 - 7:00pm - I personally noticed that the left side of my face was paralyzed when I couldn't sip from a straw to drink tea Jan 25, 2021 -8:50am - I was diagnosed (through virtual consult) with Bell's Palsy by a Doctor and put on Prednisone 20 MG - 3 Tablets per day for 7 Days , Valacyclovir HCL 1 Gram - 3 Tablets per day for 7 days Jan 29, 2021 - 4:20pm - On-site checkup with Doctor and tapered my Prednisone for additional of 3 days - 3 tabs day, 2 tabs day 2 and 1 tab day 3. Valacyclovir HCL 1 Gram was extended for another 3 more days. Same dosage Feb 1, 2021 - 9:13pm - There is very little improvement",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/22/2021,1.0,SEN,None,"On and off Fever from Dec 24, 2020 to Jan 8, 2021",None,,None,"['Chills', 'Facial asymmetry', 'Facial paralysis', 'Pyrexia', 'Steroid therapy']",1,MODERNA,SYR 993128,IL,36.0,F,"Rash developed on arm of injection- warm to the touch, very painful to touch, itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,PVT,Metoprolol,None,None,,None,"['Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",2,MODERNA,IM 993129,CA,36.0,F,"In the afternoon, I got headache and felt tired. Didn?t think much of it. Then by 6 pm I realized it wasn?t just a headache, it was a migraine, so I took my prescription Rizatriptan (5 mg disintegrating tab). By 6:30 pm migraine pain severe (worse than I?ve ever experienced in the decade of history of migraines). It went from a migraine to so insanely miserable in minutes that my husband even commented at the rapid speed it came on. Could not lie down as the pressure in my head would get worse (never had that response to a migraine). Stomach extremely upset, started vomiting around 7 pm. It was an MSG type of vomit - where I rapidly vomit 5-7 times in a matter of a seconds; however I didn?t feel better like I do after MSG vomiting. I vomited 3 different occasions between 7 pm and maybe 11 pm. I felt cold and had chills - took temperature at it was 95 degrees. Tub bath increased temp to 96. I was extremely fatigued, walking to bathroom was difficult. Had to use wall for support. Since I couldn?t lie down, I sat in a chair and between 10 pm and 1 am I would dose. Several times I woke up in a hot flash and panicked that I couldn?t breathe. My chest didn?t feel tight or anything, so thinking it was just a panic attack from the severe head pain. Around 1 am the pain in my head lessened, so I went to bed. I slept until 4 am. Around 5 am I noticed my chills subsided. The whole ordeal lasted around 12 hours. No additional symptoms throughout the day, just extremely tired from not sleeping the night before. I took my temp when I got up at 8 am at it was 98 degrees F.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/31/2021,10.0,WRK,"Rizatriptan (didn?t take at time of vaccine), zinc, NAC, vitamin B-Complex, vitamin D, Magnesium L-Threonate",None,History of migraines,,Bee allergy and MSG,"['Abdominal discomfort', 'Body temperature decreased', 'Chest discomfort', 'Chills', 'Dyspnoea', 'Fatigue', 'Gait disturbance', 'Head discomfort', 'Headache', 'Hot flush', 'Insomnia', 'Migraine', 'Nasopharyngitis', 'Panic attack', 'Vomiting']",1,MODERNA,IM 993130,TX,76.0,F,"DIZZY 5/10 1000 BLOOD PRESSURE 105/70, HEART RATE 50, OXYGEN SATURATION 97. PATIENT COMPLAINS OF DIZZINESS PATIENT IS SPANISH SPEAKING ONLY. DAUGHTER IN LAW IN CAR WITH PATIENT. PAIENT IS ALERT AND ORIENTED X3. GAVE PATIENT AN ORANGE AND BOTTLE OF GATORADE. PATIENT DENIES ANY DIFFICULTY SWALLOWING OR SHORTNESS OF BREATH. SAT WITH PATIENT FOR 10 MINUTES. 1015 PATIENT WAITED 15 MINUTES. PATIENT STATES SHE IS GOOD TO GO HOME. DAUGHTER IN LAW IS DRIVING AND IS TAKING PATIENT HOME TO EAT.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,OTH,NONE,,,,PENICILLIN,['Dizziness'],1,MODERNA,IM 993131,DC,67.0,F,"On Jan . 19, Exactly one week after vaccine (part 1) vaccine site developed a nickel size red area and about 1 1/2 inch above vaccine site a 2 inch red, hot, itchy patch appeared on my right shoulder. . There had been no discoloration prior to this . I applied a clean cold wet washcloth to shoulder area. For about an hour. That stopped itch. Next morning area still looked and felt the same-red, hot, itchy. I again applied clean cold washcloth to shoulder area. For about 30 minutes. Then applied an over counter cream ( hydrocortisone 1% plus) just to shoulder area. Used the cream again just before bed that Wednesday night and again Thursday night, only on shoulder. Itching stopped and did not resume. Redness and heat on rash faded each day until completely gone by Sunday January 24th., total of 6 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/19/2021,7.0,PUB,Synthroid,None,Hypothyroid,,Sulfa drugs,"['Erythema', 'Pruritus', 'Rash', 'Vaccination site erythema']",UNK,MODERNA, 993132,TX,87.0,F,"1545 PATEINT TOLD DAUGHTER SHE ""FEELS LIKE SOMETHING IS IN HER THROAT"" PATIENT IS SUCKING ON COUGH DROP AND IS ABLE TO SWALLOW. PATIENT IS ALERT AND ORIENTED X3. SPEAKING. 1610 PATIENT TOLD DAUGHTER SHE WAS OK TO GO HOME. PARAMEDIC INSTRUCTED DAUGHTER TO CALL 911 IF PATIENT STARTS FEELING SHORT OF BREATH OR IS UNABLE TO SWALLOW. PATIENT CONTI ES TO BE ALERT WITH ON DISTRESS NOTED",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,OTH,LOSARTAN PANTOPRAZOLE CITALOPRAM PRAVASTATIN PAZEO EYE DROPS TRAVOPROST EYE DROPS PROLIAR INJECTIONS,,,,NONE,['Sensation of foreign body'],1,MODERNA,IM 993133,HI,41.0,F,4 minutes- severe dizziness 6 minutes throat and tongue swelling 8 minutes - asthma attack,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,"Loratadine, montelukast, advair, spiriva.",Anaphylactic allergic reaction 7 days prior to vaccination.,"Asthma, allergies",,"Eggs, mango","['Asthma', 'Dizziness', 'Pharyngeal swelling', 'Swollen tongue']",1,PFIZER\BIONTECH,SYR 993134,MO,35.0,F,"1/30/21 0800 chills, muscle pain, swollen axillary lymph nodes with pain radiating to neck and down arm 0830 nausea, vomiting 0900 fever, tylenol and ibuprofen 1300 afebrile 1/30/21 - current (2/1/21) increased fatigue, muscle aches, loss of appetite, swollen axillary lymph nodes have persisted",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/29/2021,01/29/2021,0.0,WRK,none,,none,right axillary lymph node swelling with Tdap booster 10/2020,NKA,"['Chills', 'Decreased appetite', 'Fatigue', 'Lymphadenopathy', 'Myalgia', 'Nausea', 'Neck pain', 'Pain in extremity', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 993135,NV,74.0,F,"Pink rash approximately 3 inches wide and 5 inches long on left deltoid appeared day following injection, area was warm to touch for 3 days, then rash remained until 1/29/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/21/2021,1.0,PHM,"lisinopril, metropolol, oxybutinin, CBD, Advair, Potassium, magnesium,",none,"GERD, asthma, Hypertension, Prinzmetal's angina, arthritis",,zPak,"['Injection site rash', 'Injection site warmth']",UNK,MODERNA,IM 993136,CA,52.0,M,"On the evening following COVID-19 vaccine, patient had mild fever and experienced mild epigastric and bilateral upper quadrant pain. Pain continued and patient presented to the ED on 1/31/2021 with epigastric pain. Final diagnosis appears to be acute diverticulitis with microperforation and early abscess formation. No physician notes document that the two events are related; however timing is close. Patient does not have a history of gallbladder disease, abdominal disease, etc. Patient is currently admitted and followed by general surgeon.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/27/2021,01/31/2021,4.0,PVT,Multivitamin; Fish Oil,None known.,None known.,,No Known Drug Allergies,"['Abdominal pain upper', 'Abscess', 'Diverticulitis', 'Intestinal perforation', 'Pyrexia']",2,PFIZER\BIONTECH,IM 993137,,21.0,M,"pt presents with mid epigastric chest burning x1 hour after breakfast, 21 yo M w/ no known chronic medical conditions, presents w/ 2 hours MEG/central chest burning. Initial a/w mild SOB and LH; by time of my eval, LH/SOB had resolved and CP was 4/10. Pts sx completely resolved w/ GI cocktail. No exertional sx. No recent infectious sx. VS w/o acute abn. Well-appearing, NAD. Normal CV exam; no edema. LCTAB. PT transferred for troponemia.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/29/2021,02/01/2021,3.0,MIL,UNK,,,,NKDA,"['Chest X-ray normal', 'Chest pain', 'Dyspepsia', 'Dyspnoea', 'Electrocardiogram ST segment elevation', 'Full blood count normal', 'Lipase normal', 'Metabolic function test normal', 'Myocarditis', 'Troponin increased']",2,MODERNA,IM 993138,OH,69.0,F,"Anaphylactic type reactions such as dizziness, cough and throat swelling, BP drop - happened slowly within 1 hour with antihistamines taken 1 hour prior to injection ( Chlorphenerimine 4 mg, Pepcid 20 mg tabs) Swelling of feet, hands, face in 1.5 hours. Used Flucatisone nasal spray x2 , albuterol puffs x 2 and pseudophed 15 mg tablet Continued to use Antihistamines for 3 - 4 days post injection for rash and swelling. VERY FATIGUED for 3 days. Rash over trunk of body for 7- 10 days post injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,PUB,"Oscamin 0.375, Fibercon , Cranberry 500 mg, Vit C 60 mg , Lactobacillus 30 mg, Chlorpheniramine 4 mg, Pepcid 20 mg",no acute illness,"Irritable Bowel Syndrome,","rash from flu shot Fall 2020, rash from 1 previous flu shot 2014","Antibiotics: Sulfa, Quinolones, other antibiotics; Chocolate, Peanuts, other food additives. Numerous soaps, shampoos and cosmetics, cleaning products - allergens unknown.","['Anaphylactoid reaction', 'Blood pressure decreased', 'Cough', 'Dizziness', 'Fatigue', 'Peripheral swelling', 'Pharyngeal swelling', 'Rash', 'SARS-CoV-2 antibody test positive', 'Swelling face']",UNK,MODERNA,IM 993139,,41.0,F,"Swollen, itchy, painful, hot lump about 4 inches under the skin at injection site one week after receiving the shot",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/02/2021,8.0,MIL,,,,,,"['Injection site mass', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 993140,TN,74.0,M,Took nap at 4PM and woke at 6PM with one of the worst headaches I have ever had. There is some tenderness at site on left arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,SEN,Levothroxine 75 mcg tab Citalopram 10 mg Cetirizine 10 mg Aspirin 81 mg Vitamin B Complex Vitamin C 500 mg Vitamin D3 50mcg,seasonal allergy,"heart disease, hypothroidism, osteoarthritis",,None that I know of,"['Headache', 'Injection site pain']",1,PFIZER\BIONTECH,IM 993141,AR,32.0,F,Tingling around mouth and tongue. Body aches the whole next day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PVT,Losartan Protonix Lexapro Nuvaring,None,Hypertension Anxiety Depression,,NKDA,"['Pain', 'Paraesthesia oral']",UNK,PFIZER\BIONTECH,SYR 993142,CA,50.0,M,"On 1-26-2021, he presented to ED after waking up at 1AM with lip swelling and diffuse itchy rash. Rash involved both forearms, scalp, chest, abdomen, back, and legs. He took 50 mg of Benadryl at home, but woke up with worsened symptoms. Denied unusual foods, soaps, detergents, colognes, or medications. Patient denied shortness of breath, throat or intraoral swelling or pain, chest pain, palpitations, cough, sore throat, nasal congestion, rhinorrhea, fever, chills, loss of sense of taste or smell, abdominal pain, n/v, diarrhea or dysuria. Patient was treated with epinephrine 0.3 mg SQ, Solu-Medrol 125 mg, Benadryl 25 mg IV, and Pepcid 20 mg oral. Patient was re-evaluated an hour and a half after receiving medication and lipedema and urticarial improved. Patient was provided with an Rx for EpiPen kit, prednisone 40 mg daily for 3 days. He was told to follow up with his PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/26/2021,7.0,PVT,,,,,"Hydrochlorothiazide NSAIDS (Gastric Ulcer) Penicillins (SOB, swelling of throat)","['Lip swelling', 'Rash', 'Rash pruritic']",2,PFIZER\BIONTECH,IM 993143,CA,68.0,F,"Received Vac 1/28/21 @10:40 am. No adverse reaction first day. Only slight swelling and slight pain x24 hrs. on 1/29/21 started itching over abdomen area, gradually proceeded to cover entire trunk. If scratched skin turned into welts of various sizes. On 1/30/21 around 4:00 pm felt tingling around lips; by 7:00 pm lips were abnormally swollen to the point of interfering with my word pronunciation. Took Benadryl 25 mg around 7:30 pm and swelling of upper lip began to decrease. Night itching quite aggressive; rash progressed to scalp. On 1/31/21 rash progressed to arms, legs and feet. On 2/1/21 rash progressed to forehead and perimeter of face.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,OTH,Aspirin 81 mg Zinc 50 mg Vit D3 5000 iu calcium 600 mg. NAC 600 mg Vit B 100/100. oxybutynin 5 mg,none,Multiple Sclerosis,,none,"['Lip swelling', 'Pain', 'Paraesthesia oral', 'Pruritus', 'Rash', 'Swelling', 'Urticaria']",1,MODERNA,IM 993144,CA,33.0,F,"Immediately after vaccine administration had a brief episode of dizziness. The next morning (1/21/21) noted quarter-sized red rash at injection site along with fatigue, whole body aches, that later progressed into headache, nausea and overall feeling unwell. That evening experienced chills. The following morning (1/22/21) injection site redness/rash was roughly 3in in diameter and warm to touch. Right front shoulder pain began and still continues 12 days post vaccine administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/21/2021,1.0,UNK,,NONE,NONE,,NKDA,"['Arthralgia', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site rash', 'Injection site warmth', 'Malaise', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,SYR 993145,SC,31.0,F,"Chills, body aches, headache, fever, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/01/2021,02/02/2021,1.0,PVT,"Oral birth control, spirinolactone 100mg qd",None,Acne,,"Nkda, no allergies","['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,MODERNA,SYR 993146,NY,41.0,F,"Redness, Swelling and itching rash at the injection site 1 week post vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/26/2021,8.0,MIL,,,,,,"['Injection site erythema', 'Injection site rash', 'Injection site swelling', 'Rash pruritic']",1,MODERNA,IM 993147,CA,77.0,F,"Itchy and rash where vaccine was ministered. My husband age 80 who got the vaccine same time as I in left arm and has the same rash , No other symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/24/2021,01/31/2021,7.0,UNK,Crestor 5mg 1 per day Vitamin B Magnesium 500 mg per day,"Skipped heart beats, About 3 days after the vaccine I had .vertigo and headaches, but was not sure if it came from medication I took for heart burn (Pepcid)",Not really,,Non that I?m aware of,"['Dyspepsia', 'Headache', 'Injection site pruritus', 'Injection site rash', 'Vertigo']",1,MODERNA, 993148,,35.0,M,Localized redness around injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/26/2021,7.0,MIL,,,,,,['Injection site erythema'],1,MODERNA,IM 993150,OR,38.0,F,"Had some numbness that started about 20 min after the injection that lasted for about 10 min. After about an hour, my arm was swollen and very painful to move and touch. I put an ice pack on and took Tylenol but the pain and swelling didn?t completely subside. I went to bed with Tylenol PM to help me sleep and woke up several times from the pain. Throughout the day today (2nd day), the pain has steadily gotten worse. I can barely move my arm due to the immense pain. The swelling is still there. I have been icing it and taking Tylenol but the pain has only gotten worse. I feel achy in my neck and the pain is radiating down my arm to my forearm, wrist, and fingers.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,01/31/2021,0.0,PVT,Synthroid (Levothyroxine 200 mcg),,Was diagnosed with Grave?s Disease in 2009. Thyroid was ablated (no active thyroid).,,Bee stings,"['Hypoaesthesia', 'Neck pain', 'Pain', 'Pain in extremity', 'Pain of skin', 'Peripheral swelling', 'Sleep disorder']",1,MODERNA,SYR 993151,OR,31.0,F,"soreness @ injection site, 4 puffs of inhaler & advair diskus within 1st hour. No additional symptoms until 1:30 am where I was up all night. In severe systemic pain, fever, severe myo aches, some mild wheezing resolved with inhalers & migraine. Intermittent stuffy nose & sore throat but it goes away. Pain level 10. I can barely move. Dizzy & drinking water & taking otc pain meds. Unable to work or daily function",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/31/2021,1.0,OTH,"Advair diskus, Albuterol Sulfate, Singulair, Multivitamin",None known,Moderate to severe asthma & allergies,,"Augmentin, Tramadol, dogs, cats, pollen, dust, seasonal allergies","['Dizziness', 'Impaired work ability', 'Injection site pain', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Myalgia', 'Nasal congestion', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'Wheezing']",2,MODERNA,IM 993152,CA,31.0,F,"Giant hive on right side of my body above my right thigh, on the side of my hip.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/01/2021,3.0,PVT,None,None,None,,Ibuprofen,['Angioedema'],2,MODERNA,SC 993153,CA,65.0,M,"1. Pain at injection site x 48 hours 2. Arthralgia, both shoulders, both knees > 1 week",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/22/2021,1.0,PVT,"Lisinopril, ASA, Atorvastatin",None,"Htn, Mild Elevated Cholesterol",,Mango,"['Arthralgia', 'Injection site pain']",1,MODERNA,IM 993154,CA,37.0,F,"on 1/31/2021 at 11am, I woke up raised red rashes all over my body. my primary doctor advised to take zyrtec in Am and bennadryl at night. everytime antihistamine meds wears off, i seen coming back again the hives all over my body, face and lips. hives all over body and face shows up again today 2/1/21 at 1am, 11am, 9:30pm. antihistamine meds helps but keep coming back the hives. no known allergies my entire life. no changes in my diet or taking any supplement. `no pet in my house. no laundry soap changes. my doctor sent consult to allergy. waiting for response.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/31/2021,11.0,PVT,none,none,thyroid problem but not on medication,,none,"['Rash', 'Rash erythematous', 'Rash papular', 'Urticaria']",1,MODERNA,IM 993155,,40.0,M,I woke up at 1am freezing w/Headache. All my joints are aching. And my nose is plugged. Pain scale for headache was about a 4-5. so it?s like I have a normal cold. The injection site hurts to touch. A teeny bit swollen.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/02/2021,1.0,MIL,"Multi-vitamin, Vitamins C, D, E, Magnesium, B, Fish Oil, Calcium",none,"Gerd, Rt kidney slow, kidney stones, back problems, shoulder tear",,none,"['Arthralgia', 'Feeling cold', 'Headache', 'Injection site pain', 'Injection site swelling', 'Nasal congestion']",2,MODERNA,SYR 993156,WA,56.0,F,"extreme itching and 11/2 inches big redspot on arm. The itching is so severe and cannot relieved by over counter hrdrocortisone, it make me feel my heart starting beat irregularly",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/28/2021,02/01/2021,4.0,UNK,no,no,Slightly htn but under controlled,,no,"['Erythema', 'Heart rate irregular', 'Pruritus']",UNK,PFIZER\BIONTECH, 993157,CA,29.0,F,"At the time there was no pain or itchiness, only tenderness and pain the following 3 days. There was also an undefined lump underneath the injection site that was tender like the rest of my arm. Now, exactly 7 days later, the lump is more defined and very itchy. The skin is pink and slightly inflamed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/01/2021,7.0,OTH,,,,,"Sulfa, ciprofloxacin","['Dermatitis', 'Injection site mass', 'Pain', 'Pruritus', 'Skin discolouration', 'Tenderness']",1,MODERNA,SYR 993158,MN,40.0,F,"Intense arm pain and finger numbness, neck pain/stiffness on left side. Severe nausea and dizziness, vomiting/dry heaving. Headache, fever (102)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/02/2021,1.0,WRK,Viibryd,None,None,,Penicillin,"['Dizziness', 'Headache', 'Hypoaesthesia', 'Musculoskeletal stiffness', 'Nausea', 'Neck pain', 'Pain in extremity', 'Pyrexia', 'Retching', 'Vomiting']",1,MODERNA,IM 993159,NY,44.0,M,diffuse hives entire body x 4 days daily and continuously starting 2 days after vaccine administration. Treated by urgent care with steroids and benadryl but not helping,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/30/2021,2.0,PVT,Atorvastatin,None,high cholesterol,,None,['Urticaria'],2,PFIZER\BIONTECH,IM 993160,CA,69.0,F,"Changes in hearing, faint, aches in hips and neck, tight chest. Faintness was within 10 minutes of administration of vaccine. And last about 2-3 minutes. Aches lasted 2 days. Ears felt strange next day: felt as if plugged, seemed both like a loss of hearing and exaggerated hearing at same time. Roaring in ears.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,01/31/2021,0.0,PVT,None,None,"Arthritis, hyatal hernia,",,None,"['Arthralgia', 'Auditory disorder', 'Chest discomfort', 'Dizziness', 'Ear discomfort', 'Neck pain', 'Tinnitus']",1,MODERNA,SYR 993161,SC,40.0,F,"Around 6 am,( day after vaccine- approximately18 hrs after vaccine) achy legs, fever, sore arm(left arm), fatigue, headache. Lasted approximately 12 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/31/2021,1.0,OTH,N///A,,,,,"['Fatigue', 'Headache', 'Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 993162,WA,67.0,F,"Drippy nose almost 24 hours after vaccine injection followed by itchiness around mouth and nose for several hours. Took one antihistamine--chlorpheniramine. Began to feel chills 29 hours after injection. 36 hours after injection, awakened when both arms and legs felt numb. Very thirsty, 'cotton mouth'. Drank water. Will take another chlorpheniramine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,02/01/2021,1.0,PUB,none,none,none,,sulfa drugs,"['Chills', 'Hypoaesthesia', 'Pruritus', 'Rhinorrhoea', 'Thirst']",1,MODERNA,IM 993164,TX,34.0,F,Lymph edema started 3 days post injection. Started under arms. Day 4 it moved to left breast. Day 5 the swelling continued to left lower abdomen area and left labia. Skin is very tender to the touch in swollen areas,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/28/2021,3.0,PHM,,Thrush after dose 1 of Moderna vaccine,Unspecified autoimmune disease,Thrush 4 days after first Moderna vaccine,,"['Abdominal distension', 'Breast swelling', 'Labia enlarged', 'Lymphoedema', 'Oedema peripheral', 'Pain of skin']",2,MODERNA,IM 993293,PR,48.0,F,Chills Fever Pain in the middle of the chest Arthralgia Headache. Tylenol and Advil depending on the severity of symptoms at the moment,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/29/2021,1.0,SCH,Plaquemil,Discoid lupus,Discoid lupus,,Kiwiii,"['Arthralgia', 'Chest pain', 'Chills', 'Headache', 'Pyrexia']",UNK,MODERNA,IM 993296,WA,51.0,F,"Developed chills with aching long bones (thighs, low back, upper arms) early evening after injection. Profound malaise and fatigue with same pain and chills next day and continuing until 2/1/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,OTH,"Monteleukast, Wixela, Sertraline, pramiprexole, omeprazole, albuterol",None,Asthma,,"Keflex, Sulfa, ibuprofen, penicillin","['Bone pain', 'Chills', 'Fatigue', 'Malaise']",2,PFIZER\BIONTECH,IM 993298,CA,46.0,F,"Chils, headache, body ache ,diarreah, fever up to 104 Took 4 days to get better feels like if I had covid again very painful scare to take the2nd dose",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/20/2021,,UNK,When I got the vaccine and I got sick i was taking Tylenol evey 8hrs I got the chills and fever up to 104 headache body pain couldn't breath chest pain all that with the first dose still arm hurts and chest too..had covid june 24 2020,,,Moderna,,"['Chills', 'Diarrhoea', 'Fear', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA, 993302,IN,26.0,M,"Extreme headache within 30 minutes of injection. Rash/skin redness- didn?t notice until 7 hours later; chest and entire face going into part of neck. Fatigue. I took some Tylenol and fell asleep. When I woke up, only my chest was slightly red and the headache had dulled some.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/30/2021,0.0,PVT,"Lamictal, amitriptyline, atomoxetine, topiramate, testosterone, propranolol, cyclobenzoprine, sumatriptan",,"Anxiety, depression, headaches/migraines, optic neuritis in L eye, cervical radiculopathy at C7","Headache, muscle aches, fatigue. 26. Moderna COVID vaccine round 1 on 1/2/2021","Sulfa medications, adhesive","['Erythema', 'Fatigue', 'Headache', 'Rash']",2,MODERNA,IM 993304,HI,36.0,F,"Flu like symptoms approximately 8 hours following. Chills, headache, body aches. Large, hard lump at injection site. 12 hours following vaccine, severe edema in Left Axilla. Multiple swollen lymph nodes and general edema. Unable to put arm down. Symptoms subsided after 48 hours, but are pain and mild swelling are still present.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,WRK,Humalog insulin via insulin pump Multi-vitamin,None,Type 1 Diabetes,Pneumonia vaccine. Swellin in arm and neck on same side as injection. Unknown vaccine name/brand or date. Patient age: 23.,Pneumonia vaccine: arm and neck swelling on side of injection.,"['Chills', 'Headache', 'Influenza like illness', 'Injection site mass', 'Injection site movement impairment', 'Lymphadenitis']",2,PFIZER\BIONTECH,IM 993468,PR,42.0,F,"facial paralysis; stress; facial pain; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on an 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history includes ongoing facial paralysis (it was reported that the patient experienced facial paralysis caused by stress a couple of year ago and then again after the vaccination). Concomitant medications were not reported. The reporter felt worried about the patient (partner) that had facial paralysis and asked if they could administer the second dose of the vaccine of COVID-19 from Pfizer. The paralysis it was previous from the fist dose of the vaccine, a consequences of the stress, the partner had 42 years. The reporter considered that the event was non-serious. As of 15Jan2021, it was reported that the patient experienced facial paralysis caused by stress a couple of years ago and then again after the vaccination (24Dec2020). The patient also experienced pain in face on 24Dec2020. The patient underwent MRI on an unspecified date. Treatment was given for the events facial paralysis and pain in face (Anti-inflamatories). The outcome of the stress was unknown while not recovered for the other events. Information on the lot/batch number has been requested. Amendment: This follow-up report is being submitted to amend previously reported information: country of incidence was updated. Additional information received on 15Jan2021 from a contactable nurse includes: patient details (medical history and lab data), product details (therapy dates), reaction data (additional event: pain in face) and clinical course details.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of facial paralysis cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/24/2020,7.0,OTH,,,Medical History/Concurrent Conditions: Facial paralysis (facial paralysis caused by stress a couple of year ago and then again after the vaccination.); Stress,,,"['Condition aggravated', 'Facial pain', 'Facial paralysis', 'Magnetic resonance imaging']",1,PFIZER\BIONTECH,OT 993489,,72.0,F,"she has a bleeding disorder/ a cardiac procedure in the groin to stop bleeding; Hashimotos' Disease; Mixed Connective Tissue Autoimmune Disease; allergies (experienced rashes and hives) to contrast dyes; allergies to adhesive, and polymers; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (Manufacturer Control Number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-005628), license party for apixaban (ELIQUIS). This case was received via Pfizer Inc (Reference number: 2021040024) on 18Jan2021 and was forwarded to BMS on 19Jan2021. This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE THYROIDITIS (Hashimotos' Disease), MIXED CONNECTIVE TISSUE DISEASE (Mixed Connective Tissue Autoimmune Disease) and HAEMORRHAGE (she has a bleeding disorder/ a cardiac procedure in the groin to stop bleeding) in 72-year-old female patient who received apixaban (ELIQUIS) for an unknown indication. The occurrence of additional non-serious events is detailed below CO-SUSPECT PRODUCTS included COVID-19 VACCINE for an unknown indication. On an unknown date, the patient started ELIQUIS (unknown route) and COVID-19 VACCINE (Intramuscular). On an unknown date, the patient experienced AUTOIMMUNE THYROIDITIS (seriousness criterion medically significant), MIXED CONNECTIVE TISSUE DISEASE (seriousness criterion medically significant), HAEMORRHAGE (seriousness criterion medically significant), CONTRAST MEDIA ALLERGY (allergies (experienced rashes and hives) to contrast dyes) and DERMATITIS CONTACT (allergies to adhesive, and polymers). The action taken with ELIQUIS (Unknown) was unknown. At the time of the report, AUTOIMMUNE THYROIDITIS, MIXED CONNECTIVE TISSUE DISEASE, HAEMORRHAGE, CONTRAST MEDIA ALLERGY and DERMATITIS CONTACT outcome was unknown. Consumer reported that she had read the EUA Fact Sheet for Recipients and have some questions to the ""What should you mention to your vaccination provider"". Caller mentioned that she has allergies (experienced rashes and hives) to contrast dyes, adhesive, and polymers such as the angio-seal that was used on her for a cardiac procedure in the groin to stop bleeding. She has irritation from the polymer and described it as a sponge that was meant to be absorbed for a month. Her first question was does the COVID-19 vaccine contain latex, mold (polymers) and adhesive? Response: For latex. For mold (polymer) and adhesive: ""A review of the ingredients list on the product label show that mold (polymer) and adhesive are not part of the formulation, however, Pfizer does not specifically manufacture the vaccine to be free of mold (polymer) and adhesive, therefore, we cannot assure that it was ""mold (polymer)-free and adhesive free"". We cannot guarantee that minute amounts of substances are not contained in raw materials obtained from our suppliers. She had the PPSD23/Pneumonia 23 vaccine last 05Jan2021 and was told not to get the COVID-19 vaccine for 14 days. Is it because of the injection site or is it for systemic reasons? Consumer mentioned that she was on ELIQUIS. She has Hashimoto's Disease and Mixed Connective Tissue Autoimmune Disease. She said that she was not immunocompromised. She mentioned that she has a bleeding disorder. The Pfizer- BioNTech COVID-19 Vaccine can only be administered as an intramuscular injection For ELIQUIS (Unknown), the reporter did not provide any causality assessments. Reporter's causality assessment was not provided. Bristol-Myers Squibb Causality assessment for ELIQUIS: Events: Hashimoto's disease, Contrast media allergy, Topical adhesive allergy, Mixed connective tissue disease were considered unrelated while bleeding was considered related. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: BMS Medical Evaluation Comment: This patient had autoimmune thyroiditis, mixed connective tissue disease and hemorrhage after receiving apixaban therapy. This patient also had COVID-19 vaccination. Based on the anticoagulant action of apixaban, its role in the event hemorrhage is considered as possible. Based on the etiology of the reported events, auto immune thyroiditis and mixed connective tissue disorder are considered not related to apixaban.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Autoimmune thyroiditis', 'Catheterisation cardiac', 'Haemorrhage']",UNK,UNKNOWN MANUFACTURER, 993504,IL,56.0,F,"sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; severe abdominal pain; Nausea; Injection site pain; This is a spontaneous report from contactable other hcps (including patient herself). A 56-year-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid19, lot number EL3248) , via an unspecified route of administration 08Jan2021 17:30 at single dose on left deltoid for covid-19 immunisation. Medical history included covid-19 the first time in Oct2020 to an unknown date , then from 16Nov2020 to an unknown date and experienced ""every symptom except for vomiting"". The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 18Dec2020 for covid-19 immunisation and experienced neck hurting, Shingrix Vaccine on 04Dec2020 for immunization and experienced no adverse effect. The patient experienced severe abdominal pain, nausea, Injection site pain on 12Jan2021, headache, fatigue, feeling of total lack of energy on 13Jan2021, fever on 16Jan2021. She had severe abdominal pain and nausea for three days (as reported). The caller stated she took Zofran for her nausea. The caller stated she had a rapid COVID-19 Virus test that was negative, but continued to feel queasy. She stated she had 100.5-101.8 degree fevers over the weekend, and has been sleeping a lot. Reported she woke at 4:00AM on Tuesday, 12Jan2021, with severe abdominal pain. She said the abdominal pain is better but not completely gone. Abdominal Pain Treatment: Declined any. Reported she hasn't discussed with her doctor the adverse events she has been experiencing since receiving the second COVID-19 Vaccine dose. She stated she had injection site pain for 2-3 days after receiving the second COVID-19 Vaccine dose. She said she didn't have any injection site soreness with the first COVID-19 Vaccine dose. She said she thought she was good after receiving the second COVID-19 Vaccine dose, but then on Tuesday, 12Jan2021, she woke at 4:00AM with severe abdominal pain. She said the abdominal pain came in waves. She described the abdominal pain as an 8 out of 10, clarifying the abdominal pain would be sharp and then fade away, and then the abdominal pain would cycle back around. She said she found herself standing over her toilet a few times because the abdominal pain was so severe, she thought she was going to throw-up. She clarified she had nausea and took and old prescription of Zofran she had received for vertigo years ago. She stated she did not have the Zofran NDC, Lot, and Expiration Date. Reported her abdominal pain and nausea went away by Thursday, 14Jan2021, saying the abdominal pain and nausea was less and less each day. She clarified the abdominal pain and nausea were intermittent, saying all of a sudden she would not feel good. She said her nausea has been better for the past 2-3 days. She clarified she called off work on Tuesday, 12Jan2021, and on Wednesday, 13Jan2021, she had a Rapid COVID-19 Virus Test before she started work that day (13Jan2021) to make sure that she wasn't positive for the COVID-19 Virus. She said she had a headache, no energy, and felt fatigued at work on Wednesday (13Jan2021), and Thursday (14Jan2021), but didn't take her temperature during that time. She said she didn't work on Friday (15Jan2021), but continued to have the headache, fatigue, and feeling like she had no energy. She said she didn't check her temperature until Saturday, 16Jan2021. She said she woke up Saturday (16Jan2021) at 9:40AM and went back to sleep until 11:30AM. She said she woke back up at 1:42PM and her husband told her she felt hot to the touch. She said she checked her temperature and it was 101.8 degrees. She said she checked her temperature first thing this morning (18Jan2021) because she could tell she sweated overnight, and her temperature was 100.3. She said she just checked her temperature again, and her temperature was now 99.3 degrees. She said by this afternoon, her temperature will be in the 101 range. Headache & Fever Treatment: Reported she took Naproxen (clarified as a prescription Naproxen 500mg tablet), and Tylenol (clarified as Equate brand Acetaminophen 500mg tablet) for her headache and fever on Saturday (16Jan2021). She said she took the Naproxen and Acetaminophen 500mg once in the morning, and again at night, before bed. She stated she did not take any Naproxen or Acetaminophen on Sunday, 17Jan2021. Acetaminophen 500mg tablet (Equate Brand): UPC Number: Unknown, Lot Number: 0HV1335, Expiration Date: May2022 Naproxen 500mg tablet (Prescription dispensed in round, pharmacy bottle): No NDC, Lot, or Expiration Date Reported she had another COVID-19 Virus test performed on Sunday, 17Jan2021, at 11:40AM at a drive-thru test site at Pharmacy. She clarified it was a ""send-out"" PCR COVID-19 Virus test, and she had not received her test results yet. She said her belly doesn't hurt anymore. She said she doesn't have a gallbladder and appendix. She said if she had the flu, the flu lasts for 3-5 days, and she is not coughing. She said she feels like now, what she felt like when she had the COVID-19 Virus the first time in Oct2020. She said she had a 12 days of severe fatigue when she had COVID-19 in Oct2020. She said her COVID-19 Virus symptoms started on 14Oct2020 with nasal congestion, and by 16Oct2020 she couldn't taste her yogurt. She said she got tested later in the day on 16Oct2020 for the COVID-19 Virus. She clarified she definitely had no sense of smell or taste on Friday, 16Oct2020. She said on Thursday, 15Oct2020, she kept falling asleep in the evening, saying that never happens. She said on Friday, 16Oct2020, she had a fever of 100.3, as well. The outcome of the events severe abdominal pain, nausea was resolved on 14Jan2021, of Injection site pain was resolved on an unspecified date, of sleeping a lot and she sweated overnight was unknown, of other events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of abdominal pain, nausea and other events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/12/2021,4.0,PVT,,,Medical History/Concurrent Conditions: COVID-19; SARS-CoV-2 infection,,,"['Abdominal pain', 'Adverse event', 'Asthenia', 'Fatigue', 'Feeling hot', 'Headache', 'Hyperhidrosis', 'Hypersomnia', 'Impaired work ability', 'Injection site pain', 'Malaise', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH, 993505,FL,70.0,F,"Yesterday and still today it felt like I burnt the tip of my tongue; poking my tongue with needles, very painful; My tongue was numb for 2-3 hours; Arm hurt; This is a spontaneous report from a contactable consumer (patient). A 70-year old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at 10:21 at single dose in left arm for COVID-19 immunisation at the age of 70-year-old. Lot number was EL1284. Medical history included blood pressure, COVID-19 in Mar2020, loss of smell and taste in Mar2020, diarrhea in Mar2020, ongoing headache since Mar2020 (started with eyes, thought the patient had pink eye, she had a headache right at the time of report), chills in Mar2020. Concomitant medications included ongoing olmesartan for blood pressure. The patient received flu vaccine in Oct2020. The patient received her vaccine on 15Jan2021; she was informed to wait 15 minutes after getting the vaccine and she did. When she left the park about 2-3 minutes after waiting the 15-minute observation period she started to feel a sharp needle poking type feeling on her tongue, it was painful. Her daughter asked if she wanted to turn back around, but they did not. The feeling did not last long. She then added, later that day it felt like the tip of her tongue was numb. It stayed that way for at least 2 hours and then went away. On 17Jan2021, she woke up and she has the feeling on her tongue as if she drunk something hot and burnt the tip of his tongue. She has this burnt feeling sensation on her tongue and she had not eaten or drunk anything yet. Poking sensation on tip of tongue that was painful occurred like 17 minutes after she got the injection. It is like her tongue was being poked with needles. She later had numbness on her tongue, this lasted like 2 hours. It seemed like a numbing solution was administered with the vaccine. The way her tongue felt, it was as if there was a numbing solution in the needle with the vaccine. Her tongue was very numb for a while, but it then went away. On 17Jan2021, she started to feel the tip of her tongue was burnt. She looked at her tongue on 17Jan2021 and it was red. She has not looked at it the day of report so she did not know what it looked like. The patient initially stated, besides the tongue issue, she had no issues. However, she then later stated and clarified the only other issue she had was her arm hurt a little; it was not bad, but it did hurt; it did not hurt at the time of report, it started the same day she got the vaccine during the night. The patient recovered from Poking sensation on tip of tongue that was painful, Tongue numb on 15Jan2021, patient was recovering from Tip of tongue feels like it was burned, the outcome of arm pain was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,UNK,OLMESARTAN,"Headache (headache, started with eyes, thought she had pink eye, had a headache right at the time of report)",Medical History/Concurrent Conditions: Blood pressure abnormal; Chills; COVID-19; Diarrhea; Loss of smell; Loss of taste,,,"['Glossodynia', 'Hypoaesthesia oral', 'Pain in extremity', 'Paraesthesia oral', 'Tongue discomfort', 'Tongue erythema']",1,PFIZER\BIONTECH, 993506,FL,81.0,M,"the doctor was concerned that it might be a mini stroke; couldn't think of what he wanted to say; This is a spontaneous report from a contactable consumer reporting for the father. An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 08:45 at single dose in right arm because of his age group /mass senior vaccination order. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medications included blood pressure medicine since recent years. The patient previously had a flu shot (INFLUENZA VACCINE) but had that in early Nov2020. He kept saying it was the shot, but that he was fine. There were no additional vaccines administered on same date of the Pfizer Suspect. The patient got vaccinated with the Pfizer COVID vaccine on 14Jan2021. He was feeling great with no problems. He sat and waited 15 minutes, and felt fine. When they were driving home after breakfast, her mother said she was talking asking him a question, and he wouldn't respond. Her father could hear her mother asking the question, but he said he could not think of what he wanted to say. He told her he couldn't think of what he was thinking on 14Jan2021. It probably started 1 hour to 1 hour 15 minutes after vaccination, and lasted 15-20 minutes. He kept trying to think of stuff. He kept repeating this for a little bit. His wife thought he was just trying to think of something, but couldn't remember. He was 81. He was very healthy and in shape. He still rides his bike every day. He walks in the morning to play golf too. When they got home and woke up from the nap, and he felt fine. He did say it was the weirdest thing, and that it had to have come from the shot. Since then, he has felt perfectly fine. He had nothing more going on that would indicate any side effect. Her concern was that it sounded like possibly a mini stroke. Upon checking with an HCP (Healthcare professional), the doctor was concerned that it might be a mini stroke and scheduled him for a CAT (Computerised axial tomography) scan. He kept saying it had to be the shot because he has been fine ever since. He had no issues with soreness at site or anything. He didn't have a prescribing doctor. He was driving when it happened. He didn't have a slur or anything. His second appointment is on the 04Feb2021. The event did not require a visit to Emergency Room, but required a visit to Physician Office in the morning of 18Jan2021. The outcome of the event couldn't think of what he wanted to say was recovered, and of the other event was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure abnormal,,,"['Aphasia', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH, 993507,OH,,M,"He tested positive for Sars-CoV-2 in the interim; He tested positive for Sars-CoV-2 in the interim; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program Pfizer First Connect. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included exposure to a patient who was positive. The patient's concomitant medications were not reported. The patient received his first Pfizer-Biontech Covid19 vaccine on 30Dec2020, and was scheduled to receive his second dose today, 18Jan2021. He tested positive for Sars-CoV-2 in the interim and is looking for guidance on receiving the second dose. He was exposed to a patient who was positive. The patient has also tested positive. He wanted to know when he should get the second vaccine. The patient should have gotten the second dose today and was told they could get him in on Thursday which was in that 4-day window. Now, he has just been informed that they can't get him in for the second dose until Monday, which is outside to of the 4 days window and he wants guidance on this since his hospital was unsure. The outcome of the events was unknown. Information about batch/lot number has been requested.; Sender's Comments: The patient received only one dose of BNT162B2 injection and then tested positive SARS-COVID-2 on an unspecific date. Given the incomplete protection from single dose of vaccine BNT162B2 , the COVID infection is unlikely related to suspect BNT162B2 administration, but may be pre-existing/intercurrent condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,,,UNK,,,Medical History/Concurrent Conditions: Exposure to COVID-19,,,"['COVID-19', 'Inappropriate schedule of product administration', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993508,,,F,"ulcerative colitis; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). This female patient of an unspecified received bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at SINGLE DOSE for COVID-19 immunization. Medical history included she was allergic to sulfa. The patient's concomitant medications were not reported. She had ulcerative colitis and asked if that would impact anything. Outcome of the event was unkonwn. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,['Unevaluable event'],UNK,PFIZER\BIONTECH, 993509,,,F,"received first dose of vaccine and slept for two days straight; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient slept for two days straight on an unspecified date. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Hypersomnia'],1,PFIZER\BIONTECH, 993510,AZ,76.0,F,"24 hours after receiving the vaccine, I passed out while walking. I do not have any other new medications; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Arm Left on 13Jan2021 at 08:00 AM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included bronchiectasis. Patient had no known allergies. Concomitant medications in two weeks prior to the vaccination included olodaterol hydrochloride, tiotropium bromide monohydrate (STIOLTO RESPIMAT), salbutamol (ALBUTEROL HFA) and multi vitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jan2021 at 10:00 AM patient passed out while walking, 24 hours after receiving the vaccine, patient did not have any other new medications. Event resulted in emergency room/department or urgent care and hospitalization for one day. Treatments received included cast on hand, computerised tomogram (Ct) scans, electrocardiogram (EKG) and echocardiogram on unknown date with unknown results. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the event, at the time of the report.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/13/2021,01/14/2021,1.0,UNK,STIOLTO RESPIMAT; ALBUTEROL HFA,,Medical History/Concurrent Conditions: Bronchiectasis,,,"['Cast application', 'Computerised tomogram', 'Echocardiogram', 'Electrocardiogram', 'Loss of consciousness']",1,PFIZER\BIONTECH, 993511,AZ,,F,"Went to living room shaky then pass out 2-3 minutes.; chills all day; Cold sweats; little lightheaded/ feeling dizzy; Headache; feels like someone put ice cold on both ears and face; Nauseous; Feverish at night with 99.9 oral temp; Sore on in the injection site; Blurry vision; shaky; thirsty; This is a spontaneous report from a contactable other HCP reported for self. This 49-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 16Jan2021 09:15 AM on Right arm at single dose (Lot # EL1283) for covid-19 immunisation. Medical history included high Blood pressure, Known allergies: Amlodipine, Seasonal allergy. Prior to vaccination, was the patient did not diagnosed with COVID-19. Concomitant medications included Chlorthalidone 25 mg, Magnesium 500mg. No other vaccine in four weeks. The patient previously received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Dec2020 08:30 AM for covid-19 immunisation, experienced sore on in the injection site. On 17Jan2021, waking up 06:00 AM with headache, thirsty, little lightheaded, went to kitchen turn on coffee maker start feeling dizzy, nauseous, blurry vision, went to living room shaky then pass out 2-3 minutes. Cold sweats again, went to bathroom was sitting there then feels like someone put ice cold on both ears and face, cold sweats, nausea, and blurry again. Cold sweats and chills all day, feverish at night with 99.9 oral temp. Sore on in the injection site both doses. No COVID tested post vaccination. No treatments were received. Outcome of the events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the loss of consciousness and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/17/2021,1.0,UNK,CHLORTHALIDONE; MAGNESIUM,,Medical History/Concurrent Conditions: Blood pressure high; Seasonal allergy,,,"['Chills', 'Cold sweat', 'Dizziness', 'Feeling cold', 'Headache', 'Injection site pain', 'Loss of consciousness', 'Nausea', 'Pyrexia', 'Thirst', 'Tremor', 'Vision blurred']",2,PFIZER\BIONTECH, 993512,TX,,F,"Felt pricked by shoulder and has a scab there now; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age (Age: 65; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, ""I felt pricked by shoulder and has a scab there now, could this happen due to the vaccine? The site which she received her vaccine is rescheduling people for after 21 days. The patient felt two pricks. She got a scab on her shoulder. She thinks he accidently poked her. The patient stated, ""If the person that gave the vaccination pricked her shoulder before the shot could it have caused a little irritation on her shoulder? Whenever the man gave the shot, she wasn't looking at him, but he told her to hold her sleeve up. She was just trying to hold her sleeve up. He pushed his sleeve way up on her shoulder. She felt it way up on her shoulder, and thought it was strange. He squeezed her arm, and said he thought there would be good. She felt two pricks. She got a scab on her shoulder. She thinks he accidently poked her. He tried to say he thought he poked himself, but she is pretty sure he poked her. He gave the shot in her arm. He thought he had pricked himself but pricked her. Her question is, if that happens and the needle pricks the surface of the skin, can it make it blister the skin? Her main reason for calling is that she is signed up to get the second round. Now, the city she lives in is having trouble getting the vaccine. People that were supposed to get the first vaccine Monday and Tuesday had to be pushed to Wednesday because they didn't get their shipment. So now everyone will get them on Wednesday. The day she went it was very organized so she feels bad for these people. Since Pfizer is having trouble getting this shipped, then what is going to happen on 5 Feb 2021 which is the day she is supposed to get her second dose. What will happen if they don't have vaccines?"". She would just like her questions answered. Her brother said he heard somewhere the vaccine doesn't have to be given at exactly 21 days like they originally said. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Injury associated with device', 'Scab']",1,PFIZER\BIONTECH, 993513,FL,65.0,F,"headache; nausea; fatigue; sore arm; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient (not pregnant), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283), via an unspecified route of administration, on left arm on 16Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included Diverticulosis, hypothyroid, osteoarthritis, vitiligo, psoriasis, anxiety/depression, known allergies: Iodine, sulfa, bivalve shellfish, garlic, onions. Concomitant medications included first dose of pneumococcal vaccine polysacch 23v (PNEUMOVAX) on 23Dec2020 on left arm, celecoxib (CELEBREX), sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL). The patient experienced fatigue, sore arm the day after vaccine was administered on 17Jan2021. Two days after administration on 18Jan2021, patient experienced fatigue, headache, nausea. No treatment received for all events. The outcome of the events were resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/17/2021,1.0,UNK,CELEBREX; SERTRALINE; ADDERALL; SYNTHROID; CYTOMEL,,Medical History/Concurrent Conditions: Anxiety; Depression; Diverticulosis; Food allergy; Hypothyroidism; Iodine allergy; Osteoarthritis; Psoriasis; Sulfonamide allergy; Vitiligo,,,"['Fatigue', 'Headache', 'Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH, 993517,CT,39.0,F,"Anaphylactic reaction; This is a spontaneous report from a contactable Nurse (patient). This is the second of two cases and refers to events occurred with the second dose of the vaccine. A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EL1283), on 11Jan2021 at 11:00 at single dose in Deltoid Left for COVID-19 immunization. Medical history included asthma, shellfish allergy, allergy lobster (used steroids). Patient was not pregnant.The patient's concomitant medications were not reported. Previously on 22Dec2020 at 12:30 PM patient took the first dose of the vaccine (Lot EJ1685) at single dose in Deltoid Left for COVID-19 immunization and couple of days after she had nausea and something stuck in her throat. On 11Jan2021, 5 minutes after the 2nd dose (at 11:05), the patient experienced anaphylactic reaction, that required Emergency room visit. Patient was not hospitalized and was treated with diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLUMEDROL) and ""Pepcid"": she was prescribed 3-day course of oral prednisone and H2 antihistamine oral ""Pepcid"". After finished it, she felt it was coming back therefore she took diphenhydramine hydrochloride for 2 nights in a row. She did not experience any respiratory, cardiovascular, dermatological or gastrointestinal manifestation. She completely recovered in Jan2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of anaphylactic reaction due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Allergy to animal (Used steroids.); Asthma; Shellfish allergy,,,"['Anaphylactic reaction', 'Nausea', 'Sensation of foreign body']",2,PFIZER\BIONTECH, 993518,,,M,"asymptomatic but positive; asymptomatic but positive; This is a spontaneous report from a contactable Other HCP (patient's parent). A male patient (son) of unknown age received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Caller states his son went back to school and initially tested negative for SARS-Cov-2 following first dose, now is asymptomatic but positive. Asking if second dose would exacerbate. Outcome is unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the limited information available, a causal relationship between event ""asymptomatic but positive"" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be completely excluded. The case will be reevaluated should additional information become available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Asymptomatic COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993521,FL,49.0,F,"a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny nose; Cough; Anaphylaxis; This is a spontaneous report from a contactable consumer(patient). A 49-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), intramuscular in right bicep(arm) on 13Jan2021 around 16:15 at single dose for preventative. Medical history included high blood pressure from 2016 and ongoing. Concomitant medication included ongoing chlortalidone for high blood pressure. She received first dose of covid vaccine BNT162B2 (Lot: EL0140) on 23Dec2020 around 13:00., in right bicep(arm), a little above where she received this second dose for covid-19 immunization, she previously received flu shot for immunization and had a knot in her arm where it is tender to the touch and sore. She had an anaphylaxis event directly after her shot on 13Jan2021, she was kind of knocked out for the anaphylaxis event and her body was hurting. She was not sure if it was from the shot or from the trauma anaphylaxis event. She received an epi shot in the clinic, diphenhydramine (BENADRYL)into her arm. She was taken to the ER(Emergency Room) where she stayed till about 9:30pm. She was not admitted. Anaphylaxis recovered on 13Jan2021. She also stated that she got sick after the shot, she was exhibiting flu-like symptoms, she never lost her taste or smell, she had a fever, severe body aches, runny nose, and a cough. These symptoms started the next day on the 14Jan2021 and got worse on the 15Jan2021, on 17Jan2021, She feeling better morning and recovered completely by the time she went to bed in regards to her flu-like symptoms, she felt like herself and normal. She felt rested. This morning she felt good. Treatment included paracetamol (TYLENOL) and she was taking diphenhydramine every night since the anaphylaxis occurred. She still had a knot in her arm that it was very sore to the touch which she stated was pretty common even with flu shot(not know the name of the flu shot or have lot, NDC, or expiration date) where it was tender to the touch and sore. There was no relevant test. Outcome of anaphylaxis was recovered on 13Jan2021, of a knot in her arm, sore to the touch was unknown, of other events was recovered on 17Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,PVT,CHLORTHALIDONE,Blood pressure high,,,,"['Anaphylactic reaction', 'Cough', 'Immediate post-injection reaction', 'Influenza like illness', 'Injection site nodule', 'Injection site pain', 'Malaise', 'Nodule', 'Pain', 'Pain of skin', 'Pyrexia', 'Rhinorrhoea']",2,PFIZER\BIONTECH,OT 993529,FL,,U,"stroke; This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The physician reported an employee of (institute name) suffered a stroke within a week of taking the Pfizer Covid Vaccine on an unknown date. Dr. (Name) told the physician that he didn't think it was related. The event outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Very limited information is currently available. As the reported stroke occurred within a week of taking the Covid Vaccine, BNT162B2, the Company cannot completely exclude the possible causality between the reported event and the administration of the suspect. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Cerebrovascular accident'],UNK,PFIZER\BIONTECH, 993532,NC,,F,"Still experiencing upper respiratory congestion; She developed COVID 5 days after getting the 1st dose; She developed COVID 5 days after getting the 1st dose; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age(reported as Age: 66, Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed COVID 5 days after getting the 1st dose, she received the 1st dose on 29Dec2020 and due for 2nd dose on 19Jan2021. The patient was still experiencing upper respiratory congestion. She had the initial dose of the vaccine 3 weeks before and a week after her first dose, she developed Covid, she had been exposed so it just so happened, The patient was 14 days out from having COVID. She was scheduled to get the 2nd dose at the time of the report and was wondering if she needed to postpone it. The outcome of event ""still experiencing upper respiratory congestion"" was not recovered, of other events was unknown. � Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/01/2021,3.0,UNK,,,,,,"['COVID-19', 'Exposure to SARS-CoV-2', 'Upper respiratory tract congestion']",1,PFIZER\BIONTECH, 993533,WV,48.0,F,"first dose of bnt162b2 on 01Dec2020, patient was due for their second dose 30Dec2020; first dose of bnt162b2 on 01Dec2020, patient was due for their second dose 30Dec2020; patient had a positive COVID test, contracted Sars-Cov-2; patient had a positive COVID test, contracted Sars-Cov-2; This is a spontaneous report from a contactable Nurse from a Pfizer-sponsored program. A 48-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 01Dec2020 at a single dose for COVID-19 immunization. There was none medical history or concomitant medications. The patient received the vaccine on 01Dec2020, and then on 15Dec2020, patient had a positive COVID test, contracted Sars-Cov-2, and was due for their second dose 30Dec2020. She was supposed to get her second dose at the end of Dec2020, but she did not return. She stated they were caught in the middle. The patient did return for her second dose with her employer, but they turned her away. The patients second dose was supposed to be on 30Dec2020. Suspect product: Caller does not have the NDC, lot, or expiration date to provide from the first dose that the patient received. There was a Product Complaint. This is a non-serious report. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE due to temporal relationship. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,12/15/2020,14.0,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No",,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993536,SC,28.0,F,"Seizure; muscle spasm; weakness; hard to breathe at time; can't stay awake; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3346), via an unspecified route of administration at Left arm on 15Jan2021 08:00 at single dose for covid-19 immunization. Medical history included seizure, asthma, known allergies to penicillins and NSAIDs. Concomitant medication included levetiracetam, escitalopram, phenytoin, lamotrigine. The patient previously took naproxen, azithromycin, clindamycin; all experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 08:30, the patient experienced seizure, muscle spasm and weakness, hard to breathe at time, can't stay awake. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the seizure and other reported events due to temporal relationship. Of note, the patient has a medical history of seizure disorder. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,PVT,LEVETIRACETAM; ESCITALOPRAM; PHENYTOIN; LAMOTRIGINE,,Medical History/Concurrent Conditions: Allergic reaction to analgesics; Asthma; Penicillin allergy; Seizures,,,"['Asthenia', 'Condition aggravated', 'Dyspnoea', 'Muscle spasms', 'Seizure', 'Somnolence']",1,PFIZER\BIONTECH, 993538,,,F,"tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable nurse (reporting for herself). A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number and expiration date not reported), via an unspecified route of administration on 23Dec2020 as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that she received her first dose on ""23Dec and on 27Dec tested positive for Covid"". The clinical outcome of the events tested positive for Covid was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (4 days in this case). However, a causal relationship between event ""tested positive for Covid "" (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/27/2020,4.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 993539,NY,58.0,F,"tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable nurse. A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first shot of the COVID-19 vaccine on 04Jan2021 then tested positive for COVID-19 on 12Jan2021. Patient was concerned whether she should get the second shot of the COVID-19 vaccine as scheduled or should we wait. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (8 days in this case). However, a causal relationship between event ""tested positive for Covid-19 "" (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/12/2021,8.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993550,NY,28.0,F,"elevated redness sort of like a rash around the injected area; rash came back in the injected area; it was itchy; my face was swollen and ears; my face was swollen and ears; hives on my face; skin was very dry; rash like; This is a spontaneous report from a contactable healthcare professional reporting for a patient. A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 31Dec2020 at 14:00 (at the age of 28-years-old) as a single dose for Covid-19 immunization. Medical history included tuberculosis (TB) when younger and took medication for it from an unknown date. The patient was allergic to penicillin and breaks out in hives and a rash. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included spironolactone (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date after the vaccination, the patient experienced elevated redness sort of like a rash around the injected area for 2 days and then it went away, exactly a week later the rash came back in the injected area but did not spread and lasted another two days. On 14Jan2021 at 04:00 the patient experienced broke up in hives on face, face was swollen, and ears and it was itchy. The patient experienced skin was very dry and rash like but not itchy on an unknown date in Jan2021. Therapeutic measures were taken for the swelling face, ear swelling, hives and pruritis which included Benadryl for 2 days which helped the events go down. The clinical outcome of the event injection site erythema, swelling face, ear swelling, hives and pruritus was recovered; injection site rash, dry skin and rash were unknown. It was reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and suspected LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,PVT,SPIRONOLACTONE,,"Medical History/Concurrent Conditions: Penicillin allergy; Tuberculosis (when younger, took medication for it)",,,"['Dry skin', 'Ear swelling', 'Injection site erythema', 'Injection site rash', 'Pruritus', 'Swelling face', 'Urticaria']",1,PFIZER\BIONTECH,OT 993568,,25.0,F,"nausea; diarrhea; fatigue; loss of taste and smell; loss of taste and smell; stomach upset; tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 31Dec2020 at single dose at left arm for covid-19 prophylaxis. There were no medical history and concomitant medications. Patient said that she got the first dose on 31Dec2020. She stated that she got Covid 2 weeks later. She said that she positive test on 12Jan2021. She stated that she was still having mild symptoms of Covid. She said that because of that, she was not cleared to go back to work yet. She stated that she was not having fever or shortness of breath. Patient clarified that her covid-19 symptoms were stomach upset, nausea, diarrhea, loss of taste and smell, and fatigue. She was supposed to get the second dose on 19Jan2021. Outcome of all events was recovering. Information about Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/12/2021,12.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Abdominal discomfort', 'Ageusia', 'Anosmia', 'Diarrhoea', 'Fatigue', 'Impaired work ability', 'Nausea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 993572,OH,61.0,F,"thrush; weak; tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685, expiry date: unknown), via an unspecified route of administration on 21Dec2020 at a single dose for covid-19 immunisation. Medical history included ongoing COPD (chronic obstructive pulmonary disease) (not really diagnosed with COPD), ongoing smoker (smokes about 10 cigarettes a day; has smoked 40+ years), cough. The patient's concomitant medications were not reported. It was reported that on 31Dec2020, the patient tested positive for COVID from which she went to the doctor and was treated on 14Jan2021. The patient was given SOLU-MEDROL injection just to help her because she has mild COPD to bring up all of the junk. She is clear now. She doesn't have pneumonia. Her labs were good. She feels 80% back. The patient also experienced weak and thrush on unspecified date. Therapeutic measures were taken as a result of the event tested positive for COVID which included antibiotic and a cortisone injection, and for the event thrush which included NYSTATIN mouth rinse. Outcome of the event tested positive for COVID was recovering. Outcome of the remaining events was unknown.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (10 days in this case). However, a causal relationship between event ""tested positive with Covid "" (coded to Drug ineffective / COVID-19) and BNT162B2 vaccine cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/31/2020,10.0,UNK,,COPD; Smoker (smokes about 10 cigarettes a day; has smoked 40+ years),Medical History/Concurrent Conditions: Cough,,,"['Asthenia', 'Candida infection', 'Laboratory test normal', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993579,,,F,"received first dose of the vaccine on 29Dec2020 and tested positive for COVID on 11Jan2021; received first dose of the vaccine on 29Dec2020 and tested positive for COVID on 11Jan2021; This is a spontaneous report from a contactable pharmacist (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 29Dec2020 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that the patient received first dose of the vaccine on 29Dec2020 and tested positive for COVID on 11Jan2021. Patient was scheduled for her second dose this week and stated she is trying to figure out what to do. Patient asked if there are side effects if she get is earlier that the suggested 90 days. Patient also asked if there is a recommendation on what to do if it ended up running out of the vaccine before she gets her second dose. The patient underwent lab tests and procedures which included sars-cov-2 test with result of positive on 11Jan2021. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/11/2021,13.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993601,MD,28.0,M,"initial exposure to coronavirus; COVID-19 PCR test positive; COVID-19 PCR test positive; when he woke up the next morning he had a 5 minute interval of indescribable burning sensation on the face and upper torso/being hot; This is a spontaneous report from a contactable physician from a Pfizer-sponsored program. A 28-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly on 31Dec2020 in arm at a single dose to prevent COVID. There were no medical history or no concomitant medications. He confirmed he is the physician and the primary doctor for the patient. The patient is a pharmacist and he received the first dose of the Pfizer COVID vaccine on 31Dec2020. The next day (01Jan2021), he woke up with a 5-minute interval of indiscernible burning sensation on his face and upper torso that went away after about 5 minutes. The patient reported being hot for a few seconds after taking the Pfizer COVID vaccine. The patient came in to contact with some with coronavirus and then the patient tested positive for coronavirus on 17Jan2021 with a PCR test. He had no symptoms since a week after his initial exposure to coronavirus. No adverse reactions but turned up with infection. The outcome of event burning sensation on the face and upper torso was recovered on 01Jan2021, outcome of the other events was unknown. Reporter assessed seriousness for burning sensation on face and upper torso: Medically significant. Causality between burning sensation on face and upper torso and bnt162b2 was related by Primary Source Reporter per Global Introspection. Information on the batch number/lot number has been requested.; Sender's Comments: Based on the current available information , Exposure to SARS-CoV-2 is most likely related to an intercurrent condition which is not related to the suspected drug. Based on the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of other events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/01/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Burning sensation', 'COVID-19', 'Exposure to SARS-CoV-2', 'Feeling hot', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 993606,,65.0,F,"hallucinations; having stroke like symptoms; having intense headaches; felt exhausted; has pain in her arm; her vision affected/wavy lines throughout her eyes; numbness in her face, hands, and lips; This is a spontaneous report from contactable Nurse reporting for herself. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Patient age at time of vaccination was 65 years. The patient did not have reactions with other immunizations except a severe reaction with the measles, mumps, and rubella (MMR) vaccine when she was younger. She had seizures after receiving the MMR vaccine. The patient's concomitant medications were not reported. The patient mentioned she had a severe reaction. She described her adverse reaction by having intense headaches, having stroke-like symptoms in which she described as she cannot speak, having headaches, having numbness in her hands, face, and lips. She also felt exhausted. She also had some pain in her arm that she is not concerned about. She mentioned that she also has her vision affected, she couldn't drive, there were wavy lines all though her eyes. She started to have hallucinations such as seeing people that weren't there, seeing snow storms, and seeing things whipping throughout the wind. All the events started on 04Jan2021. She reported she was very sick in the hospital and is now getting well. However it was unknown if she was admitted to hospital (clarification pending). She wanted to know recommendations about the second shot of the COVID-19 vaccine because with her experience, she is not comfortable having the second shot of the COVID-19 vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,UNK,,,Medical History/Concurrent Conditions: Seizures,,,"['Fatigue', 'Fear', 'Hallucination, visual', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Impaired driving ability', 'Malaise', 'Neurological symptom', 'Pain in extremity', 'Speech disorder', 'Visual impairment']",1,PFIZER\BIONTECH, 993626,NV,49.0,F,"Lips swelling and face; Lips swelling and face; Anaphalaxis; Anaphalaxis; This is a spontaneous report from a contactable other HCP (patient). A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Eh9899) via an unspecified route of administration on 18Dec2020 18:30 at single dose in left arm for COVID-19 immunisation. She received the second dose (lot number: El1283) in right arm on 08Jan2021. Medical history included Idiopathic anaphylaxis and was allergic to penicillin, had COVID-19 from May2020 to an unknown date. Concomitant medication included unspecified birth control pills. The patient experienced anaphalaxis on 19Dec2020 06:00 AM. She talked with her doctor lips swelling and face. Treatment received for events lips swelling and face. But her question is she had an IGG antibody test and it was negative. She had COVID in May2020 and have been tracking her antibodies. She wanted to know 'does this antibody test show the same antibodies?' She had negative after the two vaccines. The patient is not pregnant. Events outcome was recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/19/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Anaphylaxis (Idiopathic anaphylaxis); COVID-19; Penicillin allergy,,,"['Anaphylactic reaction', 'Lip swelling', 'SARS-CoV-2 antibody test negative', 'Swelling face']",1,PFIZER\BIONTECH, 993629,ME,30.0,F,"Excessive vomiting for 24 hours; Excessive nausea for 24 hours; patient was pregnant at the time of the Covid-19 immunization; patient was pregnant at the time of the Covid-19 immunization; patient was pregnant at the time of the Covid-19 immunization; This is a spontaneous report from a contactable healthcare professional (patient). This healthcare professional reported information for mother. This is maternal report. A 30-year-old pregnant female patient receive bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJ1686; expiration date: unknown), via an unspecified route of administration on 18Jan2021 at a single dose for covid-19 immunization. Medical history included had COVID prior vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient received her vaccination in a nursing home/senior living facility. The patient was pregnant at the time of the Covid-19 immunization. The patient reported experiencing excessive nausea and vomiting for 24 hours (unspecified date). The patient received treatment for the adverse events which included over the counter medications. The patient was not COVID tested post vaccination. The outcome of the events nausea and vomiting was recovering while the outcome of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/18/2021,0.0,SEN,,,Medical History/Concurrent Conditions: COVID-19 (If COVID prior vaccination: Yes),,,"['Maternal exposure during pregnancy', 'Nausea', 'Off label use', 'Product use issue', 'Vomiting']",UNK,PFIZER\BIONTECH, 993636,NY,,M,"tested positive for Covid after first dose of vaccine; tested positive for Covid after first dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient receive the COVID-19 vaccine in 30Dec2020 and on 05Jan2021 he tested positive for COVID-19. He got the first dose of the vaccine on 30Dec2020 and was COVID-19 positive on 01Jan2021 and then tested negative on 08Jan2021. He was supposed to take the second dose on 19Jan2021, if he had COVID-19, he wanted to know if he needs to get the second dose or skip it. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/01/2021,2.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993639,NM,39.0,F,"Early Bell's Palsy; Facial numbness on the left side of her face; Facial numbness on the left side of her face; Facial numbness and increased sensitivity on the left side of her face; This is a spontaneous report from a pharmacist. A 39-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), intramuscular at left arm on 06Jan2021 17:00 at single dose for covid-19 immunization. Medical history included allergic rhinitis, deviated nasal septum, factor V leiden, gastroesophageal reflux disease (GERD), history of deep vein thrombosis (DVT), hypertension, neck pain on left side, rhinitis, rhomboid muscle strain and pain. No known allergies. Concomitant medication included fluoxetine, acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE), fluticasone, hydrochlorothiazide, lisinopril, loratadine, meloxicam, omeprazole, oxycodone for pain, sodium chloride. The historical vaccine included the first dose of BNT162B2 (Lot number: EJ1685) via intramuscular at left arm on 17Dec2020 04:15 PM and the paitent did notice some numbness on the right side of face after receiving the first dose of vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced facial numbness and increased sensitivity on the left side of her face. There was no facial droop or lid lag. Other cranial nerves are stable. Concern for early Bell's Palsy would be treated with valganciclovir and prednisone. The adverse events (AE) started from 15Jan2021 09:00. AE resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment valganciclovir 1gm q8h, prednisone 20mg 3-day taper for AE. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.; Sender's Comments: Based on the temporal relationship, the association between the event early Bell's paly with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/15/2021,9.0,PVT,FLUOXETINE; EXCEDRIN MIGRAINE; FLUTICASONE; HYDROCHLOROTHIAZIDE; LISINOPRIL; LORATADINE; MELOXICAM; OMEPRAZOLE; OXYCODONE; SODIUM CHLORIDE,,Medical History/Concurrent Conditions: Allergic rhinitis; Deep vein thrombosis; Deviated nasal septum; Factor V Leiden thrombophilia; GERD; Hypertension; Muscle strain; Neck pain; Pain; Rhinitis,,,"['Hyperaesthesia', 'Hypoaesthesia']",2,PFIZER\BIONTECH,OT 993644,,,F,"Two people got covid after receiving the first shot; Two people got covid after receiving the first shot; This is a spontaneous report received from a non-contactable consumer. This consumer reported similar events for 2 patients. This is the first of two reports. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that two people got Covid after receiving the first shot. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021065167 same reporter/drug/ae, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 993645,,,F,"she tested positive for covid after first dose; she tested positive for covid after first dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for covid after first dose in Jan2021 with outcome of unknown. Second dose scheduled for Saturday. She was in quarantine for two weeks. She would like to know if she should get second dose or not. The patient underwent lab tests and procedures which included covid 19 test: positive in Jan2021. Serious: No. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993667,NY,,U,"3 of her staff members tested positive after taking the 1st dose/They got a result for asymptomatic 3 employees that tested positive with COVID 19; 3 of her staff members tested positive after taking the 1st dose/They got a result for asymptomatic 3 employees that tested positive with COVID 19; This is a spontaneous report from a Pfizer Sponsored Program. A contactable Nurse reported similar events for 3 patients. This is 1st of 3 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive with COVID 19 on 11Jan2021. Outcome of events was unknown. Information about lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 05Jan2021, and tested positive with COVID-19 on 11Jan2021. No complete protection of the suspect vaccine could be reasonably achieved to prevent from the targeted infection due to the very short time lag. The positive COVID-19 is more likely pre-existing infection prior to vaccine use, and unrelated to BNT162B2 based on the limitedly available information.,Linked Report(s) : US-PFIZER INC-2021049694 Pfizer, Same drug, same event, different patient;US-PFIZER INC-2021049695 Pfizer, Same drug, same event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/11/2021,6.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993668,NY,,U,"3 of her staff members tested positive after taking the 1stdose/3 of her workers tested positive for Covid; 3 of her staff members tested positive after taking the 1stdose/3 of her workers tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable nurse reported same events for 3 patients. This is second of 3 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive after taking the first dose on 11Jan2021. The event was reported as non-serious. The patient underwent lab tests and procedures which included Covid: positive on an unspecified date. The outcome of events was unknown. Got the first shot on the 05Jan2021 for all of the 50 employees and 70 residents. On 11Jan2021, they got a result for asymptomatic 3 employees that tested positive with COVID 19. Health professional had questions about 2nd dose guidelines. Information about lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 05Jan2021, and COVID-19 test positive on 11Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.,Linked Report(s) : US-PFIZER INC-2021049693 same reporter/ drug/ event, different patients;US-PFIZER INC-2021049695 same reporter/ drug/ event, different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/11/2021,6.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993669,NY,,U,"tested positive after taking the 1stdose/tested positive for Covid/they got a result for asymptomatic employee that tested positive with COVID 19; tested positive after taking the 1stdose/tested positive for Covid/they got a result for asymptomatic employee that tested positive with COVID 19; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A contactable Nurse reported similar events for 3 patients.This is 3rd of 3 reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan202 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid after taking the 1st dose/got a result for asymptomatic employee that tested positive with covid 19 on 11Jan2021. The nurse reported that got the first shot on the 05Jan2021 for all of the 50 employees and 70 residents. On 11Jan2021, they got a result for asymptomatic 3 employees that tested positive with COVID 19. HCP had questions about 2nd dose guidelines, if they can take the second shot after testing positive. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021049693 same reporter/ drug/ event, different patients.;US-PFIZER INC-2021049694 same reporter/ drug/ event, different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/11/2021,6.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993675,NY,51.0,F,"tested positive after receiving the Covid-19 vaccine; tested positive after receiving the Covid-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse. This case refers to the first of three employees tested positive for Covid-19 after receiving the vaccine. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL0140, expiry date Mar2021), via an unspecified route of administration, on 05Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 51-years-old. Medical history and concomitant medications were unknown. The patient was tested on 08Jan2021. She received the results on 12Jan2021 and tested positive after receiving the Covid-19 vaccine. She is asymptomatic. It hasn't affected her but she has not been able to work. The event was reported serious as medically significant. Outcome was unknown. She states she was asking about getting 2nd vaccine.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive based on the known safety profile. However the short duration of 3 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/08/2021,3.0,UNK,,,,,,"['Asymptomatic COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993678,DE,50.0,F,"Diagnosed with Bell's Palsy from Covid-19 injection (1st dose.)/left sided face droop; Stroke; Lower left pain under ear, sudden onset; This is a spontaneous report from two contactable consumers. A 50-year-old female patient (not pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 08:30 at single dose for COVID-19 immunisation. Medical history included depression, anxiety, Post-traumatic stress disorder (PTSD), elevated pressure increased (BP), elevated cholesterol, spondylosis with radiculopathy. Known allergies: NSAID's and augmentin. Concomitant medications included hydrochlorothiazide, venlafaxine hydrochloride (EFFEXOR), hydroxyzine, atorvastatin and ascorbic acid;betacarotene;biotin; calcium; chloride; chromium; copper; folic acid; iodine; iron; magnesium; manganese; molybdenum; nickel; nicotinic acid; pantothenic acid; phosphorus; potassium; pyridoxine hydrochloride; riboflavin; selenium; silicon; thiamine; vanadium; vitamin B12 NOS; vitamin D NOS; vitamin E NOS; vitamin K NOS; xantofyl; zinc (CENTRUM SILVER WOMEN 50+). On 05Jan2021 at 13:00, patient experienced lower left pain under ear, sudden onset. Then, noticed symptoms of a stroke. Left sided face droop. Patient went to ER (emergency room). Patient was diagnosed with Bell's Palsy from Covid-19 injection (1st dose). Patient received treatments for the events included prednisone, acyclovir, ointment to protect eye and eye patch for covering of left eye. Lab test included Nasal Swab: negative on 07Jan2021. Outcome of the events was resolving. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/05/2021,5.0,PUB,HYDROCHLOROTHIAZIDE; EFFEXOR; HYDROXYZINE; ATORVASTATIN; CENTRUM SILVER WOMEN 50+,,Medical History/Concurrent Conditions: Anxiety; Cholesterol blood increased; Depression; Elevated BP; Post-traumatic stress disorder; Radiculopathy; Spondylosis,,,"['Ear pain', 'Facial paralysis', 'Viral test negative']",1,PFIZER\BIONTECH, 993680,CA,,F,"hallucinating; hands are very swollen; fever; she was also 'really swollen' not just on the injection site but on her hands and face.; she was also 'really swollen' not just on the injection site but on her hands and face.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL8982), via an unspecified route of administration on an unspecified date single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced hallucinating, hands are very swollen, fever, she was also 'really swollen' not just on the injection site but on her hands and face, all on an unknown date. The events outcome was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Hallucination', 'Injection site swelling', 'Peripheral swelling', 'Pyrexia', 'Swelling face']",UNK,PFIZER\BIONTECH, 993685,,,F,"covid test which came back positive; covid test which came back positive; This is a spontaneous report from a Pfizer-sponsored program . A contactable female consumer (patient) of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she received the vaccine and then took Covid test which came back positive (unknown date). The patient would like to know if it is safe for her to get second dose. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993688,CA,,U,"tested positive for COVID; tested positive for COVID; back pain; heavy cold symptoms; fatigue; Experienced a sore arm for 24 hours; This is a spontaneous report from a contactable Nurse (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her vaccine in the left arm deltoid on 23Dec2020. The patient experienced a sore arm for 24 hours in Dec2021. On 31Dec2020, she experienced back pain, heavy cold symptoms and fatigue. On 05Jan2021, the patient was tested positive for COVID. On 09Jan2021 she lost taste and smell. On 14Jan2021, she tested negative for COVID. As of today, 19Jan2021, she has not been able to go back to work. Event took place after use of product. The outcome of event sore arm was recovered on an unspecified date. The outcome of event COVID-19 was recovered on 14Jan2021. The outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/01/2020,,UNK,,,,,,"['Ageusia', 'Anosmia', 'Back pain', 'COVID-19', 'Fatigue', 'Nasopharyngitis', 'Pain in extremity', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 993692,TX,,F,"tested positive for Covid; tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reporting for self that a female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller is due for a second dose of covid vaccine tomorrow. She has tested positive for covid before second dose. Outcome of events was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993695,NY,97.0,F,"Couldn't speak, slurring words, stuttering, couldn't formulate a sentence; stroke; This is a spontaneous report from a contactable consumer. A 97-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 14:15 at single dose for covid-19 immunization. Medical history included ongoing atrial fibrillation(A-flib), took medication for that. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), rosuvastatin calcium (CRESTOR). Additional vaccines administered on same date of pfizer suspect reported as no. Prior vaccinations within 4 weeks, AES follow prior vaccinations and family medical history all reported as no. The patient got her first dose on 16Jan2021 and that evening she began to have a stroke. The patient was on blood thinners (apixaban(ELIQUIS) and questor). Event reported as ""Couldn't speak, slurring words, stuttering, couldn't formulate a sentence"" with onset date 16Jan2021. Event was serious as hospitalization from 17Jan2021 to 18Jan2021. The outcome of the events was not recovered/not resolved. Patient was caller's mother. Four hours later, patient couldn't speak and was slurring words. Ambulance was called, vitals were checked, and patient was told she was ok. Next morning patient was the same. Ambulance was called again and patient had a stroke. Caller stated the stroke was very coincidental. Patient had the COVID-19 Vaccine at about 2PM. Patient had A-fib. Stroke affected patient's speech, but not terribly. Patient was on a blood thinner at the time of the report because of MRI and CT scan results. The patient was taking acetylsalicylic acid (BABY ASPIRIN), but that was taken away at time of the report. The patient was on rosuvastatin calcium (CRESTOR) 0.5 at time of the report. Next appointment for second COVID-19 Vaccine was 06Feb2021. Caller was concerned. Patient never had a stroke before. The reporter wanted to know if this had been previously reported. Saturday night was when patient's speech began slurring. The patient had the Pfizer COVID-19 Vaccine that afternoon. EMS didn't take patient to the hospital on Saturday night, just took vitals and left. Patient's speech was going in and out. Caller reached out to patient Sunday morning and patient was having the same speech issues. Patient was stuttering and couldn't formulate a sentence. Ambulance was called and patient was transported to (health center). CT scan and MRI showed patient had a stroke in the area of the brain that affect speech. Patient had an echocardiogram. Clarified patient's speech symptoms began on Saturday, 16Jan2021. � Information of lot/batch number has been requested.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/16/2021,01/16/2021,0.0,UNK,BABY ASPIRIN; CRESTOR,AFib (Patient Medical comments: Verbatim: A-fib takes medication for that),,,,"['Aphasia', 'Cerebrovascular accident', 'Computerised tomogram abnormal', 'Dysarthria', 'Echocardiogram', 'Magnetic resonance imaging brain abnormal']",1,PFIZER\BIONTECH, 993696,PA,46.0,F,"had COVID symptoms and tested positive for Covid; had COVID symptoms and tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program COVAX US Support. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730, expiry date not provided) on 28Dec2020 17:30 at single dose in the left arm via an unspecified route of administration for COVID-19 immunisation . There were no relevant medical history and no concomitant medications. The patient took the first dose of the vaccine on 28Dec2020 and by the end of that week she had COVID symptoms. She got tested on that Saturday (02Jan2021) and it was negative, so she went to an urgent care to get tested again on 04Jan2021 and she was positive. She was not visit physician office or emergency room. She was out of quarantine on 14Jan2021, and was due to go get her second dose of the vaccine on 18Jan2021. She was calling to make sure if it's okay to get it. The outcome was unknown.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (7 days in this case). However, a causal relationship between event ""had COVID symptoms and tested positive for Covid"" (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993723,NY,,F,tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) from a contactable consumer reported (patient). This female patient of unspecified age received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunisation. Medical history was unknown. Concomitant medications were none. The patient got first covid19 vaccine on 28Dec2020. She tested positive for the covid virus on 29Dec2020. She was scheduled to get second vaccine today (18Jan2021) but she did not get it since she did not know if she should. She had been negative for the covid virus for one week. She was asking when she should get second dose. Outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/29/2020,1.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993726,CA,,F,"patient tested positive 6 days after the 1st dose; patient tested positive 6 days after the 1st dose; This is a spontaneous report from a Pfizer-sponsored Program, Pfizer. A contactable physician reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive 6 days after the 1st dose. The patient asked about the ingredients of COVID-19 Vaccine. The outcome of the event was unknown. Information on the batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993736,AR,43.0,F,"Tested positive for COVID-19 this week; COVID-19; This is a spontaneous report from a Pfizer-sponsored program Pfizer. A contactable consumer (patient) reported that a 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3249), via an unspecified route of administration in left arm on 07Jan2021 13:30 at single dose for covid-19 immunization (vaccination). Medical history included pleurisy. Family medical history was none. There were no concomitant medications. Historically she felt like she had the flu when she had gotten the flu vaccine (years not specified); but she did not feel like she had the flu after getting flu vaccine this year in 2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no additional vaccines administered on same date of the Pfizer suspect. The patient received the Pfizer COVID-19 vaccine 07Jan2021; and she tested positive for COVID-19 this week. Then clarified that she was administered first dose of Pfizer COVID-19 Vaccine 07Jan2021. She had onset of COVID-19 around 15Jan2021 when she became unable to smell. She had 2 COVID-19 tests performed on 16Jan2021, one was a rapid COVID-19 nasal swab test with positive result; the other was a COVID-19 nasal swab test that they had to send off to test which was also positive. No medications were taken prior to vaccination/event. She asked if she should still get the second dose as scheduled relative to this event. Second dose was scheduled for 27Jan2021. No emergency room visit required, physician office visit (urgent care) required for event COVID-19. She mentioned she was not the only patient to test positive for COVID-19 that received Pfizer COVID-19 Vaccine same date she received Pfizer COVID-19 Vaccine on 07Jan2021. She declined to provide any further information regarding those patients/events/products/report. The sample of product was not available to return. The outcome of events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/15/2021,8.0,UNK,,,Medical History/Concurrent Conditions: Pleurisy,,,"['Anosmia', 'COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993737,SD,,F,"tested positive after the first dose; tested positive after the first dose; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of bnt162b2 (COVID vaccine), lot number: EL0140, via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller, a registered nurse, calling about the COVID vaccine. She explained there was no problem but more of a concern. It was explained that on 29Dec2020 she got her first dose and on 08Jan2021 she found out she tested positive for COVID. She would be on day 12 tomorrow when the facility would be giving the second dose. She was told she can't get the second dose by her administrator as she was going by the 14 day requirement. Caller wanted to know if this was true, was it 14 days or 10 days after testing positive before she can get the next shot. If this was true, where can she get the second dose as she would miss the dose at her facility. The outcome of the events was unknown. Pfizer is a marketing authorization holder of [COVID vaccine] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [COVID vaccine] has submitted the same report to the regulatory authorities.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/08/2021,10.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993738,,,U,"tested positive after first dose was given; tested positive after first dose was given; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse reported similar events for 3 patients. This is the first of 3 reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not provided) via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had tested positive on an unspecified date in Jan2021, after the first dose of the vaccine was given. The second dose was set up and the patient would be off of the 14-day quarantine by then, but the reporter was not sure if the people was eligible to get the second dose. The outcome of the event was unknown. Information about Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 test positive and suspected LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021058678 Same reporter/ vaccine, different patient/ similar AE;US-PFIZER INC-2021058679 Same reporter/ vaccine, different patient/ similar AE;US-PFIZER INC-2021058679 Same reporter/ vaccine, different patient/ similar AE",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993740,OK,64.0,F,"Sore arm immediately after getting second dose of COVID Vaccine; Chills; Myalgia; severe headache; Nausea; She felt like she had a temperature and by the time it was checked her temperature was 101.9/febrile; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at left upper arm on 07Jan2021 14:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, not a Military Facility. The patient's medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient got the Flu Vaccine last part of Sep2020 or Beginning of Oct2020. The patient received the first dose of BNT162B2 (lot number: EK57530), via an unspecified route of administration at left Upper arm on 17Dec2020 9:10AM for covid-19 immunization. She only had a sore arm. It started the same day, a couple of hours after getting the vaccine. It went away a day to a day and a half after it started. After that she was fine. She got the second dose on 07Jan2021. After the second dose, immediately, like within five minutes her arm became very sore, this event was assessed as non-serious by HCP. Also, that Thursday (07Jan2021) night after getting the second dose of the Vaccine around 9PM-10PM she started to get chills, myalgia, severe headache, and nausea. She also mentioned she was so sick during the night she was not able to get up and around. She felt like she had a temperature and by the time it was checked her temperature was 101.9. She was febrile all through 08Jan2021. She started to become afebrile 09Jan2021 with improvement and by 10Jan2021 all her symptoms had gone away and completely resolved. Seriousness Criteria: Stated she felt these are serious. She was unable to go to work on Friday. She could not return back to work until Monday. The HCP assessed all events were related to the vaccine. The outcome of the events was recovered on 10Jan2021. She stated, even though she got so sick with getting the vaccine she was just continuously telling her self this is better than having COVID. She stated she even told people even if she knew after getting the shot she would have this reaction she would still take it. She has seen death occur from COVID and does not want that to happen.; Sender's Comments: Based on plausible temporal relationship, clinical course and known safety profile of the product, the reported events chills, myalgia, severe headache, nausea and fever were likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Headache', 'Immediate post-injection reaction', 'Impaired work ability', 'Mobility decreased', 'Myalgia', 'Nausea', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH, 993744,,,U,"tested positive; tested positive; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse reported similar events for 3 patients. This is the second of 3 reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not provided) via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had tested positive on an unspecified date in Jan2021, after the first dose of the vaccine was given. The second dose was set up and the patient would be off of the 14-day quarantine by then, but the reporter was not sure if the people was eligible to get the second dose. The outcome of the event was unknown. Information about Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021058398 same reporter/vaccine/AE and different patients.;US-PFIZER INC-2021058679 same reporter/vaccine/AE and different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993745,,,U,"tested positive after receiving first vaccination; tested positive after receiving first vaccination; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse reported similar events for 3 patients. This is the third of 3 reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not provided) via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had tested positive after receiving first vaccination in Jan2021. The second dose was set up and the patient would be off of the 14-day quarantine by then, but the reporter was not sure if those who tested positive were still advised to get the second vaccine. The outcome of the events was unknown. Information about Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 test positive and suspected LOE due to temporal relationship. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021058398 Same reporter/ vaccine, different patient/ similar AE",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993750,NJ,,M,"a patient in a nursing home facility that tested positive after receiving the first COVID vaccine; a patient in a nursing home facility that tested positive after receiving the first COVID vaccine; This is a spontaneous report from a contactable Nurse via a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at first single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive after receiving the first covid vaccine. The patient is asymptomatic. The reporter just need to know if she can give this man the second vaccine. Outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,SEN,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993751,NY,25.0,F,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; joint pain hips and back; arm pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) on 08Jan2021 at 12:30 PM (that is 09Jan2021 00:30 AM) in the left arm at single dose for COVID-19 immunization. None Medical History. Concomitant product includes ongoing ethinylestradiol, ferrous fumarate, norethisterone (KAITLIB FE) for oral contraceptive taking for a long time. No Prior Vaccinations within 4 weeks. Patient received the first dose of the vaccine on 08Jan2021 at 12:30 PM and then COVID-19 PCR test positive the following 12Jan2021. Clinical course as: On 09Jan2021, some arm pain at the injection site. On 10Jan2021, she had some joint pain hips and back; chills. On 10Jan2021 night into 11Jan2021 she had some nasal congestion. On 12Jan2021, she lost her sense of taste and smell. All of these effects have resolved except for the loss of taste and smell. She is planning to get the next dose on 29Jan2021. Patient was asking about getting the second dose of the vaccine since she tested positive. She tested negative prior on 04Jan2021; 06Jan2021 and 08Jan2021, until 12Jan2021 when she was tested positive. No events require a visit to physician or ER. The outcome of arm pain and joint pain was recovered on 10Jan2021, of other event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/09/2021,0.0,PVT,KAITLIB FE,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Ageusia', 'Anosmia', 'Arthralgia', 'Back pain', 'COVID-19', 'Chills', 'Injection site pain', 'Nasal congestion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993769,NY,50.0,F,"diarrhea; vomiting; Upset stomach; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: ELO142), via an unspecified route of administration on 15Jan2021 13:00 at a single dose in left arm for COVID-19 immunization. Medical history included Hodgkin lymphoma, thyroid cancer, breast cancer and hypothyroidism, known allergies: allopurinol. There was no other vaccine in four weeks. Concomitant medications: There was other medications in two weeks, but unspecified. The patient experienced upset stomach about 2 hours after vaccination was administered (15Jan2021 15:00), then diarrhea and vomiting both on 16Jan2021 15:00 (as reported) (about 14 hours after vaccine was given). No treatment received. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No COVID prior vaccination and no COVID tested post vaccination. The outcome of events was recovered on an unspecified date in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,PVT,,,"Medical History/Concurrent Conditions: Breast cancer female; Hodgkin's lymphoma (Hodgkin lymphoma, thyroid cancer, breast cancer and hypothyroidism); Hypothyroidism; Thyroid cancer",,,"['Abdominal discomfort', 'Diarrhoea', 'Vomiting']",1,PFIZER\BIONTECH, 993779,IL,43.0,F,"Headache; Pain at site of injection; Chills; This is a spontaneous report from a non-contactable healthcare professional (HCP) (Patient). A 43-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 15Jan2021 19:45 at a single dose in left arm for COVID-19 immunization. There were no medical history or concomitant medications. No known allergies. No other vaccine in four weeks and no other medications in two weeks. On 16Jan2021, the patient experienced headache, pain at site of injection, chills. No treatment received for events. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No COVID prior vaccination and no COVID tested post vaccination. The outcome of events was recovered on an unspecified date in Jan2021. No follow-up attempts are possible. Information about batch/ lot number cannot be obtained. No further information expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/16/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Headache', 'Injection site pain']",1,PFIZER\BIONTECH, 993787,MA,,M,"it was worse for him after her received the COVID-19 Vaccine shot than having the COVID-19 Virus; it was worse for him after her received the COVID-19 Vaccine shot than having the COVID-19 Virus; This is a spontaneous report from a contactable consumer reported for friend's father. A male patient of unspecified age received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient had COVID-19, and also had a severe reaction to the first shot. That was like 10 times worse than Covid itself. He had pretty rough time with it and it was worse for him after her received the COVID-19 Vaccine shot than having the COVID-19 Virus. Outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Adverse event following immunisation', 'Ill-defined disorder']",1,PFIZER\BIONTECH, 993790,TN,78.0,F,"she had a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest; Chest tightness; like she was going to faint or go to sleep; like she was going to faint or go to sleep; she barely had a little pain at the COVID-19 Vaccine injection site that went away quickly; This is a spontaneous report from a contactable consumer, the patient. This 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249), dose 1 , single dose via an unspecified route of administration in the left upper arm on 08Jan2021 at 09:15 AM (at the age of 78 years-old) for COVID-19 vaccination. Relevant medical history included ongoing high blood pressure in Dec2020. Concomitant medications included valsartan (DIOVAN) 160mg tablet, once a day from 10Dec2020 and ongoing for high blood pressure and clobazem (CALM) from Jan2021, lot: 1115941, expiration: Mar2022. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 08Jan2021 at 09:15 AM, the patient barely had a little pain at the COVID-19 vaccine injection site that went away quickly. On 18Jan2021, the patient had chest tightness and a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest. She said it was like she was going to faint or go to sleep. She said the wave went down to her chest area and stayed for a big portion of the day. She said she had a heaviness in her chest, clarified as a chest tightness. She said she has no heart issues. The patient still had some tightness in her chest and it may be just from worry. She said she was normally calm, so she was not sure about what was causing her current chest tightness. The patient did not think what she experienced on 18Jan2021 was serious enough to contact her primary care doctor. There were no relevant laboratory tests done. The patient did not require a visit to the emergency room or physician's office. The clinical outcome of event, barely had a little pain at the COVID-19 vaccine injection site was recovered on an unknown date in Jan2021. The clinical outcome of event, wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head was recovered on 18Jan2021 after treatment was given. The clinical outcome of chest tightness was recovering after treatment was given. The clinical outcome of like she was going to faint or go to sleep was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PUB,DIOVAN; CALM,Blood pressure high (Verbatim: Blood pressure high),,,,"['Anxiety', 'Blood pressure increased', 'Chest discomfort', 'Condition aggravated', 'Dizziness', 'Feeling abnormal', 'Injection site pain', 'Weight increased']",UNK,PFIZER\BIONTECH, 993792,TN,,U,"came down with COVID in a week of vaccination; came down with COVID in a week of vaccination; This is spontaneous report from a contactable physician. This physician reported similar events for four patients. This is the 1st of four reports. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 immunisation. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient came down with COVID in a week of vaccination. The outcome of the event came down with COVID in a week was unknown. The reporting physician stated that he doesn't think that them getting the vaccine and having COVID is related, he thinks it is a coincidence. Information on batch/lot number has been requested.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (a week in this case). However, a causal relationship between event ""came down with COVID in a week of vaccination"" (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely excluded,Linked Report(s) : US-PFIZER INC-2021064978 same reporter/drug/event, different paitent;US-PFIZER INC-2021064979 same reporter/drug/event, different paitent;US-PFIZER INC-2021072675 same reporter/drug/event, different paitent;US-PFIZER INC-2021072675 same reporter/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993793,TN,,U,"they all came down with COVID in a week; they all came down with COVID in a week; This is a spontaneous report from a contactable physician. This physician reported similar events for 4 patients. This is 2nd of 4 reports. An elderly patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, an unknown date as a single dose for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient came down with COVID in a week of vaccination. The outcome of the event came down with COVID in a week was unknown. The reporting physician stated that he doesn't think that them getting the vaccine and having COVID is related, he thinks it is a coincidence. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (a week in this case). However, a causal relationship between event ""came down with COVID in a week of vaccination"" (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-2021064977 as same reporter/drug/AE/different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993797,,,F,"got covid after receiving the first shot; got covid after receiving the first shot; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for two patients. This is second of two reports. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got COVID after receiving the first shot on an unspecified date. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046083 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 993822,,,M,"he got both doses then a few days later he died; This is a spontaneous report from a contactable consumer reporting for a friend's father. A male patient of an unspecified age received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient received the first dose on an unknown date. The patient died few days after receiving the second dose of the vaccine on an unspecified date. It was not reported if an autopsy was performed. Information about lot/batch number has been requested.; Reported Cause(s) of Death: he got both doses then a few days later he died",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],2,PFIZER\BIONTECH, 993823,,,M,"died due to heart attack; This is a spontaneous report from a contactable consumer (reporting for her son-in-law) from the Pfizer-sponsored program Pfizer First Connect. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient died due to heart attack on an unspecified date. The patient died on an unspecified date. It was unknown if an autopsy was performed. Follow-up (28Jan2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Reported Cause(s) of Death: died due to heart attack",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Death', 'Myocardial infarction']",1,PFIZER\BIONTECH, 993824,NJ,80.0,M,loss of hearing; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 12:00 PM at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if patient had COVID prior vaccination. The patient experienced loss of hearing the day after vaccination administered on 19Jan2021. It was unknown if treatment was received and unknown if patient had tested COVID post vaccination. The outcome of event was unknown. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,01/19/2021,1.0,PUB,,,,,,['Deafness'],UNK,PFIZER\BIONTECH, 993828,FL,85.0,M,"Heart stopped; Could not swallow; This is a spontaneous report from a contactable nurse (patient's wife). An 85-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. Medical history included blood pressure abnormal (verbatim: blood pressure) from an unknown date and unknown if ongoing, neuropathy from an unknown date and unknown if ongoing, weight issue from an unknown date and unknown if ongoing, diabetes from an unknown date and unknown if ongoing, walker user from an unknown date and unknown if ongoing. Concomitant medications included insulin aspart (NOVOLOG) taken for diabetes from an unspecified date to an unspecified date; and he was taking a long acting one as well. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) for immunization on unknown dates (""had flu shots before with no reactions and everything, nothing before""). On 24Jan2021, the patient's heart stopped (death, medically significant), and could not swallow (medically significant). The clinical course was reported as follows: The patient's wife stated the patient was taking insulin aspart (NOVOLOG) and he was taking a long acting one as well. The reporter, the patient's wife and a retired registered nurse (RN) stated, her husband (patient) just died and she thought he died from the COVID vaccine (later clarified the reason of death was-heart stopped). The patient had the vaccine on 21Jan2021, which was on a Thursday, and he was fine. On the following Sunday around 1:30 (on 24Jan2021), the patient was feeling a little weak, however, the patient's wife thought maybe his blood sugar was low. The patient's wife checked, and the patient's blood sugar was 91. The patient's wife went to get some yogurt to feed him in order to get his blood sugar up a little; ""which was a normal thing for him, it was not that low for him."" Then, suddenly, the patient fell, and the patient's wife could not get a pulse or anything. The patient's wife called an unspecified number and she started compressions; however, he was dead. The patient's wife stated the patient just had his heart test, a three hour long one, and it was ""perfect three weeks ago."" The patient had just gone to the doctor the other day and his blood pressure was ""fine and everything."" The patient's wife stated that other than his diabetes, ""which he had for (sentence incomplete)."" Regarding lab tests, the patient's wife stated, ""No, he had it before but not in the last two weeks. He was going for one because we just went to the doctor last week and he was going to call yesterday to make the appointment request to get his blood work done. Blood work has been good except his A1C was always high, but other than that everything was good"" (as reported). Regarding causality, the patient's wife stated, ""I do, because he was fine until about half an hour before he died. He said to me, I feel a little weak today and then I was talking to him that your upper body strength is really good and then I said, we just have to work on your weight a little more because he did have neuropathy. And then, I went out of the room and all of a sudden I just heard him fall and that is when I just went in to check his blood sugar and it was 91 and I got him yogurt and he started eating that and then that was it, he started spitting it out and he said, I could not swallow and that was it, he just died."" The patient's wife further added, ""I just wanted other people to know that things like this happen and I am sure it was from that because he was healthy as could be. He was walking with his walker, the day before outside and he felt fine."" The clinical outcome of the event, heart stopped, was fatal. The clinical outcome of the event, could not swallow, was unknown. The patient died on 24Jan2021 due to ""heart stopped."" An autopsy was not performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Reported Cause(s) of Death: Heart stopped",Yes,01/24/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/24/2021,3.0,UNK,NOVOLOG,,Medical History/Concurrent Conditions: Blood pressure abnormal (Verbatim: Blood pressure); Diabetes; Neuropathy; Walker user; Weight abnormal,,,"['Asthenia', 'Blood glucose normal', 'Cardiac arrest', 'Death', 'Dysphagia', 'Fall', 'Glycosylated haemoglobin increased', 'Pulse absent', 'Resuscitation']",1,PFIZER\BIONTECH, 993831,MA,36.0,F,"After I have the Pfizer vaccine, with 15 minutes I started having a small cough. The cough increased; my throat swollen; hard to breath; This is a spontaneous report from a contactable other hcp (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: El9261) at left arm via an unspecified route of administration on 22Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included known allergies: Apple, pear, peach, pineapple, mango, avocado and almonds. Concomitant medications included unspecified multivitamins. No other vaccine in four weeks. After patient had the bnt162b2, with 15 minutes she started having a small cough on 22Jan2021 15:15. The cough increased, her throat swollen and hard to breath on 22Jan2021 15:15. The nurse immediately gave her the epi pen and Benadryl. She had to rush to the ER. When she got there, she needed to have the second round of epi pen and more Benadryl. Events resulted in life threatening illness (immediate risk of death from the event). No covid prior vaccination. The patient was not pregnant at time of vaccination. The patient underwent lab tests and procedures, which included Nasal Swab on 25Jan2021 with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events cough, throat swelling and difficulty breathing. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Fruit allergy,,,"['Cough', 'Dyspnoea', 'Pharyngeal swelling', 'Viral test negative']",1,PFIZER\BIONTECH, 993832,ME,,U,"At the end of the conversation, caller stated that recently saw in (place name) that someone passed away 3 hours after receiving the injection.; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Caller, calling on behalf of her sister who has pseudocholinesterase imbalance, would like to know if the Covid vaccine has any contraindication or interaction with succinylcholine. Caller stated that her and her sister are scheduled to receive the first dose of the vaccine this weekend. Caller stated that her sister had a severe reaction to succinylcholine and did not wake up for four days. Caller stated that her sister has to wear a medical bracelet because of this condition. Caller reported that her sister's son has the same severe reaction to succinylcholine. Caller also stated that when she was a director in the lab, she heard of a person passing away in the OR due to the same reaction with succinylcholine. At the end of the conversation, caller stated that recently saw in (state name) that someone passed away 3 hours after receiving the injection. It was unknow if autopsy was done. Information on the lot/Batch number has been requested.; Sender's Comments: The information currently available does not allow a medically meaningful assessment for the event ""passed away"" with unknown cause of death. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.; Reported Cause(s) of Death: At the end of the conversation, caller stated that recently saw in (place name) that someone passed away 3 hours after receiving the injection.",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],UNK,PFIZER\BIONTECH, 993833,FL,27.0,F,"She received her first dose of the Covid vaccine and then tested positive for Covid; She received her first dose of the Covid vaccine and then tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program. A contactable 27-year-old female other HCP (medical assistant, patient) received 1st of BNT162B2 (Batch/lot number: EK5730) Intramuscular on 04Jan2021 at single dose (0.3 ml) for covid-19 immunization. Medical history and concomitant drug were not reported. She received her first dose of the Covid vaccine and then tested positive for Covid. She was calling to see what she should do about the second dose. Outcome of the event was unknown. No follow-up attempts possible. No further information expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported ""tested positive for Covid"".",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/01/2021,,PVT,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,OT 993834,,,U,"Contacted Covid after their first vaccine; Contacted Covid after their first vaccine; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. The consumer reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient contacted COVID after their first vaccine. The outcome of events was unknown. Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021086942 the same reporter, product and similar adverse events in different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 993838,CA,56.0,F,"severe itching; had some different allergies; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the first dose of BNT162B2 for COVID-19 immunisation on 28Dec2020, and the patient had no side effects. The patient got the second COVID shot (vaccine) and she had a reaction to it, she had some different allergies and she got severe itching on 16Jan2021, admitted into emergency room from 16Jan2021 to 16Jan2021. Seriousness of the events was hospitalization. The patient stayed at the site for a while because the itching didn't end they wanted the patient to go into an Emergency Room (ER) but they were able to get it under control and the patient was fine today. The patient received diphenhydramine hydrochloride (BENADRYL) and steroids for the events. The outcome of the events was unknown. The reporter considered that the events were related to BNT162B2. Information on the lot/ batch number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between events ""reaction to it, she had some different allergies and she got severe itching"" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/16/2021,01/16/2021,0.0,PVT,,,,,,['Pruritus'],2,PFIZER\BIONTECH, 993847,,,U,"Contacted Covid after their first vaccine; Contacted Covid after their first vaccine; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). This consumer reported similar events for two patients. This is the first of two reports. A patient (reported as: healthcare professional) of unspecified age and gender received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: contacted COVID after their first vaccine (medically significant). The clinical outcome of the events, drug ineffective and COVID-19, was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082538 same reporter, drugs and events.; different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 993850,IN,62.0,F,"tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer, the spouse of the patient. A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left arm on 28Dec2020 (at the age of 62-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing lupus from an unknown date. Concomitant medications included unspecified medications for her Lupus. On 08Jan2021, the patient tested positive for COVID-19. On 18Jan2021, the patient had an X-ray with unknown results. Therapeutic measures were taken as a result of testing positive for COVID-19 and included an unspecified infusion. The clinical outcome of tested positive for COVID-19 was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/08/2021,11.0,UNK,,,Medical History/Concurrent Conditions: Lupus syndrome,,,"['COVID-19', 'SARS-CoV-2 test positive', 'X-ray']",1,PFIZER\BIONTECH, 993852,,,M,"Tested positive after taking the first shot of the vaccine; Tested positive after taking the first shot of the vaccine; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A Non contactable male consumer reported that a male patient of an unspecified age received bnt162b2 (BNT162B2, Covid-19 Vaccine from Pfizer), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive after taking the first shot of the vaccine on an unspecified date with outcome of unknown. He wanted to know if he can still take the second dose. He really need to know as he had been scheduled to receive his send dose tomorrow. He really need to know whether to show up or not. The patient underwent lab tests which included sars-cov-2 test: positive on unknown date. No follow up attempts are possible. Information about Lot/ Batch could not be obtained.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 993861,TX,48.0,M,"Tightness in right side of my chest; This is a spontaneous report from a contactable consumer (patient). This 48-year-old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1695 or EL1695 and Expiration date 31Mar2021) on 06Jan2021 (at 48 years of age) as single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient experienced tightness in right side of chest on an unspecified date. Patient called to see if this was a common event as patient was going to the hospital shortly to be sure nothing was wrong. Outcome of event tightness in right side of chest was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,,,PVT,,,,,,['Chest discomfort'],UNK,PFIZER\BIONTECH, 993866,CA,74.0,F,arm pain at injection site & small comma rash at bottom of injection site two weeks later now have red rash area size of baseball no pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,PVT,none,none,none,,none,"['Injection site pain', 'Injection site rash', 'Rash erythematous']",UNK,MODERNA,IM 993867,IN,42.0,M,Achy body chills headache rash on neck,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/31/2021,1.0,PVT,No,No,No,,Penicillin,"['Chills', 'Headache', 'Pain', 'Rash']",2,MODERNA,SYR 993868,CA,25.0,F,Moderate injection site pain followed by lymphadenopathy,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/11/2021,7.0,UNK,"Low-ogestrel, zyrtec",,Asthma,,Seasonal allergies,"['Injection site pain', 'Lymphadenopathy']",1,MODERNA,IM 993869,NJ,46.0,F,"Severe Nausea as well as a sore arm was persistent for 3 days following the injection. In addition, a rash appeared on the left side of my back and left thigh.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/29/2021,1.0,SCH,None,None,None,,None,"['Injection site pain', 'Nausea', 'Rash']",1,MODERNA,SYR 993870,IL,49.0,F,"Full blown flu symptoms. Fever, aches, cough, head conjestion, exhaustion, memory loss, depression, loss of appetite, diarrhea. Missed 5 days of work",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/26/2021,1.0,PUB,None,None,None,,None,"['Amnesia', 'Cough', 'Decreased appetite', 'Depression', 'Diarrhoea', 'Fatigue', 'Head discomfort', 'Impaired work ability', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,SYR 993957,,,U,"A patient has received the first dose of the vaccine and his second dose is due tomorrow. 4 days ago the patient tested positive and is nonsymptomatic; A patient has received the first dose of the vaccine and his second dose is due tomorrow. 4 days ago the patient tested positive and is nonsymptomatic; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date unknown, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has received the first dose of the vaccine and his second dose was due tomorrow (19Jan2021). 4 days ago (14Jan2021), the patient tested positive for Covid test and was not symptomatic. The doctor asked to call the company to see if it was alright to give the second dose. The outcome of the event was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Asymptomatic COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 993958,,,F,"tested positive for the virus; tested positive for the virus; This is a spontaneous report from a non-contactable Nurse (patient). A female patient of an unspecified age (58 unit unspecified) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 29Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer vaccine, and on the 8th (Jan2021) tested positive for the virus. The facility she was tested at stated that the patient cannot get the shot for 14 days for the quarantine time. The patient wanted to know if she has to wait 10 or 14 days to get the vaccine and tomorrow was day 12. The patient informed that she was due to get her 2nd dose tomorrow (19Jan2021). The outcome of the events tested positive for the virus was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/08/2021,10.0,UNK,,,,,,['SARS-CoV-2 test positive'],1,PFIZER\BIONTECH, 993959,MI,81.0,M,"hit was head and it was bleeding; hit was head and it was bleeding; dizzy; fell; Nauseous; This is a spontaneous report from a contactable consumer (Husband). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 18:00 on Arm left at single dose (Lot # EL3249) for covid-19 immunisation. Medical history and concomitant medications were none. He did fine right after, his arm wasn't sore, he felt fine. The next day he had nothing, no soreness, nothing, he felt great the next day. Dizziness started in the morning 17Jan2021 when he got up he said good morning and then said he would bring her back a cup coffee then he became very dizzy and leaned against the wall for support and then he fell, he was okay but he fell. He did go the emergency room because he fell and hit was head and it was bleeding. They told him it was not related to the vaccine but it is one of the things that are on the form that could happen. She says it was okay if it caused it she is just looking for a reason. Now today (18Jan2021) he feels fine she wants to know what causes that side effect. She says she is supposed to be getting her vaccine too. He had one bad dizzy spell and then it went away, and she thinks he got kind of nauseous with it. It says this can happen, it said it could happen right after but in his case it did not, it happened within probably 34 hours or something. Outcome of the event dizziness has recovered completely at this point. Outcome of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/17/2021,2.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Balance disorder', 'Dizziness', 'Fall', 'Haemorrhage', 'Head injury', 'Nausea']",1,PFIZER\BIONTECH, 993960,NC,72.0,F,"she got it Thursday and that night she noticed a little itching/itching a little again in the palm of her hands; some face soreness; her BP was 152/85 that was high; she has to got the rash on her behind where she has been scratching; having an allergic reaction; a little puffiness on her lip; the cellulitis part of her skin; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3247), via an unspecified route of administration on 14-JAN-2021 at the 72 years old at single dose for COVID-19 immunization. The medical history included COPD so sometimes she would cough, kidney stent, rheumatoid (""two"" Tylenol and 20 mg prednisone for ""her rheumatoid""). The concomitant medication was clarithromycin (MACROBID) from an unspecified date to 12Jan2021. The patient got it on the 14Jan2021. She says she had been doing fine she didn't know now. She was a retired paramedic so she usually felt things out, she got it Thursday and that night she noticed a little itching on 14Jan2021 but she did not think anything of it. Friday evening she had a good time eating some walnuts and she woke up about 2:30 itching that was Saturday morning before day, she took Benadryl and went back to sleep later then later on she was itching a little again in the palm of her hands and she just took a Benadryl and it went away. Then Sunday night, last night, she was okay so she decided to go to the pharmacy to get some Benadryl, they had no Benadryl and she only had old Benadry. Then about 12:30 she started itching on her bottom, itching on her arms and she was scratching. She noticed she was having some face soreness in Jan2021 but she was using some expired facial cream so she thought that was why her face was sore so she put some hydrocortisone cream on it. Since she was itching she decided to take a little of her nieces Benadryl, it is pediatric Benadryl. She was itching so she called her doctor and she heard him in the ER say they had too many people in there to tell her to go to the ER so she said okay. She hung up and called the pharmacy and they said it sounds like having an allergic reaction in Jan2021 and she told him she had the COVID vaccine but she doesn't think she was short of breath and she gave them her vitals her BP was 152/85(BP 157/85) that was high for her in Jan2021, but it came down, she took some Tylenol then it was 146/77, her pulse rate was 77 and her respirations were good she did not have shortness of breath or cough well she has COPD so sometimes she would cough. Then she got up and said let me go one over and get some Benadryl so she went by there got some good Benadryl and she thought she would call and see what they think about all this. She took the Benadryl at 10:25 and she is doing okay right now but she had whelps, she has to got the rash on her behind where she has been scratching in Jan2021, it is on the left side of her hip, the cellulitis part of her skin that is mostly where she is itching in Jan2021. She remembers when she worked at the health department they would give Benadryl and Prednisone. She thought if the Benadryl does not help then she would call, then she decided she would go ahead and call to see what information they have. She says Pfizer is giving her alerts that she has been answering but she did not have the itching at that time. She retired from being a paramedic in 2009. She says she is 72 now but she woke up in 1985 and her lip was swollen like not totally swollen but her top lip was swollen more than the bottom in Jan2021. They gave her an Epinephrine shot and Benadryl and she is just wondering if this itching is related to the vaccine or if it is just an allergy that she may have come up on or something like to the walnuts or something. She says they went there and they gave the shot and they gave Benadryl but they are not sure. She said the doctor never figured our what it was that cause it and it never happened again until she did notice a little puffiness on her lip again this morning. She said the itching first started around 2:34 AM in the morning before light. It had improved since taking up to date Benadryl. She was supposed to get her second dose 04Feb2021. She didn't want COVID 19. She knew she just came off, she had a kidney stent and she had stopped taking 2 days before, she was taking Macrobid. She was not taking that right now. She took a lot of other medications but the Macrobid she was just on and it was stopped on Tuesday 12Jan2021, 2 days before the vaccine. She didn't know if the Macrobid would interfere with getting vaccine. The outcome of the event itching was recovering, the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/01/2021,,UNK,MACROBID [CLARITHROMYCIN],,"Medical History/Concurrent Conditions: COPD; Cough; Rheumatoid factor (Consumed ""two"" Tylenol and 20 mg prednisone she has for ""her rheumatoid"".); Stent placement",,,"['Facial pain', 'Hypertension', 'Lip swelling', 'Pruritus', 'Rash pruritic', 'Scratch', 'Urticaria']",1,PFIZER\BIONTECH, 993962,PA,37.0,M,"Lymphangitis of left underarm, swollen out to size of softball; administration date=16Jan2021/ 31Dec2020; This is a spontaneous report from a contactable other HCP(patient). A 37-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK4176), via an unspecified route of administration at left arm on 16Jan2021 16:45 at single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux disease(GERD), insomnia. There was no Known allergies. Concomitant medication included zolpidem tartrate (AMBIEN), pantoprazole sodium sesquihydrate (PROTONIX). There was no other vaccine in four weeks. Patient previously first dose BNT162B2(lot number=EK5730) on 31Dec2020, 19:00 at Left arm at single dose for COVID-19 immunization. The patient experienced Lymphangitis of left underarm, swollen out to size of softball on 18Jan2021 10:00, occupational health advised to get seen,went to Emergency room, urgent care recommended paracetamol (TYLENOL)for swelling and no anti-inflammatories that may hinder the immune process. Treatment paracetamol was received. Outcome of the event was recovering. There was no covid tested post vaccination.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported ""Lymphangitis of left underarm, swollen out to size of softball"" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/16/2021,0.0,PVT,AMBIEN; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE],,Medical History/Concurrent Conditions: GERD; Insomnia,,,"['Lymphadenopathy', 'Lymphangitis']",2,PFIZER\BIONTECH, 993963,WV,69.0,M,Received a Moderna vaccine at another clinic 12/30/20. 1/27/2021 he received a Pfizer vaccine at clinic,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,PUB,,,,,,['Product substitution issue'],2,PFIZER\BIONTECH,IM 993964,FL,64.0,M,"Fever to 101.7 body weakness sweats dysentery feeling of malaise, duration ran 48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PUB,Metform,Non,Diabetic,,None,"['Asthenia', 'Dysentery', 'Hyperhidrosis', 'Malaise', 'Pyrexia']",2,MODERNA,SYR 993966,,44.0,F,"Intermittent tingling/numbness to left arm after vaccine x 8 days after. Intermittent tingling/numbness to left leg after vaccine x 8 days after. Noticed small erythematic area 3 cm x 3 cm around injection site. ED MD noted, no cellulitis.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/25/2021,02/02/2021,8.0,MIL,,,,,,"['Hypoaesthesia', 'Injection site erythema', 'Paraesthesia']",1,MODERNA,IM 993967,FL,65.0,M,"For informational purposes, I am a health care provider myself. I have been experiencing severe episodes of vertigo, starting approximately 1 week after receiving my first dose of the Pfizer vaccine, and only when lying in bed. They occur a few times per night, and have occurred essentially every night since they started. They are very intense, but also very short in duration, of about 3-5 seconds. When I called my primary care physician to see if she had any thoughts, or suggestions, or if she thought it could be due to the vaccine, she informed me that she also had the same reaction, severe vertigo, while lying in bed, at about the same time period, 1 week after her first injection, although she just had 2 isolated episodes of it, and she had the Moderna vaccine. Neither of us have seen any published information listing this as a side effect of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/22/2021,8.0,PVT,Losartan 100mg daily Zyrtec 10mg daily Methyl B!@ 1000mcg 2x/week Vitamin D3 5000iu 4x/week,,,,,['Vertigo positional'],1,PFIZER\BIONTECH,IM 993969,CA,27.0,F,?Moderna COVID-19 Vaccine EAU? Fever and chills for 1 day and sore arms for 3-4 days Took tylenol for the fever and cold compress for the sore arms.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PVT,Tylenol,,"Asthma, PCOS",,None,"['Chills', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 993970,,40.0,F,"8 days after my 1st vaccination, I woke up to the injection site being swollen, hot, red & extremely itchy. The swelling is about 2-3 inches in diameter.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,02/02/2021,8.0,MIL,No,No,No,,No,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 993998,CA,92.0,F,"passed away; cough; This is a spontaneous report from a contactable consumer, the patient's daughter. A 92-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 13Jan2021 at 11:00 (at the age of 92-years-old) as a single dose for COVID-19 immunization. Ongoing medical history included nursing home resident, admitted to hospice on 13Jan2021 (prior to vaccination), and oxygen supplementation (due to low oxygen levels) from a few days prior to the vaccine (Jan2021). Other relevant medical history included congestive heart failure from Dec2020 and sulfa allergy. Prior to the vaccination, the patient was tested numerous times (as reported) for COVID-19 and was negative. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. A few days before the vaccination, her oxygen level had gone down, and she had been placed on oxygen. Prior to receiving the vaccine, the patient was reported as being 'fine'. On 13Jan2021, the patient received the vaccine at 11:00. The patient coughed maybe 5 or 6 times and then dropped her head. Resuscitation was not performed as patient had a do not resuscitate (DNR) order. The patient passed away on 13Jan2021 at 13:05. The cause of death was not reported. An autopsy was not performed. The clinical outcome of the cough was unknown at the time of death. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away",Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/13/2021,0.0,SEN,,Hospice care (prior to vaccination); Living in nursing home; Oxygen supplementation (few days before vaccine was given oxygen level was low and started on oxygen),Medical History/Concurrent Conditions: Congestive heart failure; Sulfonamide allergy,,,"['Cough', 'Death', 'Posture abnormal']",1,PFIZER\BIONTECH, 993999,NC,81.0,F,"Bleeding/felt blood on her arm /blood was coming from the top of the band aid; This is a spontaneous report from a contactable consumer reporting for self. This 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3248) via unspecified route of administration on 14Jan2021 02:00 PM at right arm at single dose for COVID-19 vaccination, clopidogrel (manufacturer: Aurobindo, lot# QR7520022-A, expiry date: Apr2022) oral from Dec2020 at 75 mg once a day for TIA (Transient ischaemic attack). Medical history included TIA from Aug2019. She had her first TIA Aug2019, and then had her second a couple months ago, it was not as severe, the buildings moved and she walked like she was drunk, but had only one other thing than walking funny and buildings moving, she can't remember what that was. Pain, blood cholesterol abnormal. Pain in both of her arms, she said her left arm hurt more than her right arm from time to time, and when the left started hurting she took all the pills, but she didn't take Hydrocodone though it is prescribed, she didn't take that unless she was in a lot more pain than usual. She said her doctors said different things about her arm pain, one said she had a torn rotator cuff, another said arthritis, someone else said it was something in her neck but it was a big word that she didn't know, she just knew she had pain. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN, manufacturer: Bayer, UPC number: 349483 48150) from Aug2019 for TIA; carbamazepine from Jan2021 for pain in both of her arms; metoprolol succinate, had been taking it a couple years; zolpidem; hydrocodone for pain (she only takes if she is dying of pain, clarified to being in a lot of pain); atorvastatin for cholesterol. The patient reported that she had COVID-19 and experienced side effect. She said it happened after the 15 minutes observation when she left to drive home on 14Jan2021. She said 5 minutes into her drive she felt blood on her arm and put her hand in her shirt, and wiped it, saw blood. She said the bleeding was weird so she pulled over to look at her arm, and blood was coming from the top of the band aid where normally it would seep down from the bottom. She used five baby wipe, and wiped a lot of blood, until finally she thought it stopped bleeding. She was not light headed or in pain, it was a 45 minute drive and she got home and was still bleeding so she took her shirt off and put a towel around it to stop the bleeding and it finally stopped. She said she didn't think to report it until her doctor said to when she told him, he had said maybe the girl who gave her the shot hit a vein, but she should tell them. She said maybe she did hit a vein, because she had never had problems when getting a shot or more than a spot of blood in the past. She said one thing that may be important was that she had a couple of TIAs, many series (unable to clarify) her doctor friend assessed that with three MRIs and MRAs. She said she just refilled one of her medications, Clopidogrel, and was reading the instructions for it and it says it can cause excessive bleeding. She said that she was not bleeding so she didn't worry about it, that maybe that caused excessive bleeding. She had not had a second dose, but she didn't want to go through this again with the bleeding, though if it was just a vein or air that may not happen. She said she was very healthy, no underlying conditions at all, never had a problem before, her arm was not painful, she was not light headed. She said the baby wipe she had on her arm after the car ride was full of blood, and she still couldn't get the band aid off, so she wrapped her arm towel kept sopping up blood until finally it quit. She put another band aid over the bloody band aid, and it quit and she was fine. She had no injection site pain, no tiredness, no headache. Lab data included she had MRIs and MRAs, but there was no bleeding. The action taken for clopidogrel was unknown. The outcome of event was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,01/14/2021,44.0,UNK,BABY ASPIRIN; CARBAMAZEPINE; METOPROLOL SUCCINATE; ZOLPIDEM; HYDROCODONE; ATORVASTATIN; CLOPIDOGREL,,Medical History/Concurrent Conditions: Blood cholesterol abnormal; Pain; Pain in arm; TIA (second); TIA (first),,,"['Angiogram normal', 'Haemorrhage', 'Magnetic resonance imaging normal']",1,PFIZER\BIONTECH, 994000,FL,,U,"faint; dizzy; funny taste in mouth; urine issues; diarrhea; upset stomach; feeling abnormal; This is a spontaneous report from a contactable consumer. This consumer reported same events for two patients (one is patient self). This is the second of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced faint, dizzy, funny taste in mouth, urine issues, diarrhea, upset stomach, feeling abnormal. The outcome of event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021044692 Same reporter/ vaccine/ AEs, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['Abdominal discomfort', 'Diarrhoea', 'Dizziness', 'Feeling abnormal', 'Syncope', 'Taste disorder', 'Urinary tract disorder']",UNK,PFIZER\BIONTECH, 994001,OH,50.0,F,Initially started swelling then the arm became red with a large blister few days later skin peeled,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,PVT,"Metformin, Lisinopril, Vascepa, Viibryd",none,"DM, HTN, depression, hyperlipidemia",,NKA,"['Blister', 'Erythema', 'Haematocrit normal', 'Haemoglobin normal', 'Lymphocyte count increased', 'Mean cell haemoglobin concentration decreased', 'Mean cell haemoglobin decreased', 'Mean cell volume normal', 'Mean platelet volume increased', 'Neutrophil count decreased', 'Peripheral swelling', 'Platelet count normal', 'Red blood cell count normal', 'Skin exfoliation', 'White blood cell count normal']",1,MODERNA,IM 994002,,35.0,F,"discomfort/soreness at injection site ten days following vaccination, after immediate injection site soreness/discomfort had subsided for over a week.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/31/2021,11.0,PUB,,,,,,"['Injection site discomfort', 'Injection site pain']",UNK,MODERNA, 994004,PA,51.0,M,"Swelling in axillary region of the right arm, the arm the injection was administered",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/30/2021,1.0,WRK,Vitamin B Complex,,,,Possibly penicillin,['Oedema peripheral'],2,PFIZER\BIONTECH,SYR 994005,AZ,36.0,M,"At around 11pm I had the chills, I was shaking pretty bad, no fever and I had a major headache. I do not have any access to tylenol and I will wait to take some when I arrive home at 7am. Its about 530am and I still have a headache. I've been drinking lots of water and I feel nauseous now.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,OTH,"Just my one a day for men's, fish oil, and vitamin C pills. Taken at 4pm",,,,,"['Chills', 'Headache', 'Nausea', 'Tremor']",2,PFIZER\BIONTECH, 994006,OH,74.0,M,"Pfizer-BioNTech COVID-19 Vaccine EUA COVID 19/Pfizer EL 9264 Nausea, tiredness, headache, muscle pain, flu Like symptoms, Ached all over for 14 hours......took Advil and symptoms subsided",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/31/2021,02/01/2021,1.0,PHM,"Prilosec, Magnesium Oxide, Fiber Capsules, Multivitamin, Calcium with D3",NONE,NONE,,NONE,"['Fatigue', 'Headache', 'Influenza like illness', 'Myalgia', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,IM 994007,PR,34.0,F,The first dose of vaccine gave me nasal bleeding on the ninth day and the second dose gave me nasal bleeding on the second day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/11/2021,9.0,UNK,I?m not taking any medication.,No,No,,No allergies,['Epistaxis'],2,MODERNA,IM 994008,VA,60.0,F,"FEVER FOR ABOUT 24 HOURS, HEADACHE FOR ABOUT 24 HOURS AND LEFT ARM RED AND WARM TO TOUCH FOR 36 HOURS",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/30/2021,17.0,PVT,"STELARA, VITAMIN D, ZYRTEC,SYNTHROID, CALCIUM MAGNESIUM, MULT-VITAMIN, OMEGA XL, FOSAMAX",NONE,"HYPOTHYROIDISM, PSORIATIC ARTHRITIS, OSTEOPEROSIS",,NKA,"['Erythema', 'Headache', 'Pyrexia', 'Skin warm']",1,UNKNOWN MANUFACTURER,SYR 994009,DC,69.0,F,"Some vaccine leaked out of suringe onto my arm as was being injected. I had also taken 400 mg of ibuprofen at 8 am to prermpt any side effects, not knowing that might impact anyobody development. I am concerned i wont have adequate antibodies from both events",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/31/2021,01/31/2021,0.0,OTH,Ibuprofen took 400 mg at 8 am Atorvastatin Hctz,None,Hbp High cholesterol,,Erythromycin Oxycodone Tropical fruits,"['Exposure via skin contact', 'Syringe issue', 'Underdose']",2,MODERNA, 994010,MA,29.0,F,"1/29: sore Left arm 1/30: rash on Left arm 2/1: rash on Left arm improved, sore armpit 2/2: rash on left armpit with itchiness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/30/2021,2.0,PVT,Lexapro Omeprazole Birth control,,,,NKA,"['Pain in extremity', 'Pruritus', 'Rash']",2,MODERNA,IM 994011,NJ,29.0,F,"~18 hours after second moderna vaccine, I experienced High fever ~101F, sweating, chills. Lymph nodes around neck are swollen. Significant arm pain at site of injection, which is extremely painful and unable to lift or lay on arm. Mild headache and joing pains.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/02/2021,1.0,WRK,None,None,None,,None,"['Arthralgia', 'Chills', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Joint range of motion decreased', 'Lymphadenopathy', 'Pyrexia', 'Sleep disorder']",2,MODERNA, 994012,NH,63.0,F,"Started to notice severe left-sided lumbar spine pain, severe left iliac crest pain radiating down left leg to above knee area, lymphatic edema. Treatment with acupuncture and massage therapy has helped alleviate the severity of the previous mentioned symptoms to where they are now tolerable. Slight chest heaviness and slight exacerbation of asthma symptoms which have been controlled with asthma inhalers.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/23/2021,8.0,PVT,"Advair 500/50 inhaler, baclofen 10 mg, celebrex 100 mg, famotidine 20 mg, hydrochlorothiazide 25 mg, levothroxine 75 mcg, Nasacort, trazodone 50 mg, Tylenol 500 mg, Zoloft 50 mg, and Zyrtec.",None.,"Asthma, allergic rhinitis, high blood pressure, fibromyalgia, migraines, osteoarthritis of knees, and pancreatic cyst.",,Allergic to acyclovir and clarithromycin medications. Shellfish allergy. MSG causes severe migraines.,"['Acupuncture', 'Asthma', 'Bone pain', 'Chest discomfort', 'Lymphoedema', 'Pain', 'Pain in extremity', 'Spinal pain']",1,MODERNA,SYR 994013,NY,69.0,F,2:AM on Feb 18 started chills while sleeping. Had hot tea and blankets and it subsided. fever of 100-101 throughout the day. Sleeping. Pain at injection site . Symptoms lasted about a day and a half. This was the first dose!,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/17/2021,01/18/2021,1.0,PVT,"lisinpril 5mg, Simvastatin 10mg, L-Thyroxine 112mcg, low dose aspirin",none,,,"CIPRO (tongue swelling, throat constricting) Erythromycin - mild","['Chills', 'Injection site pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 994014,MA,52.0,F,"Yesterday, Feb 1st around 5 p.m., I noticed a rash on my neck and my neck became very itchy. Today, Feb 2nd, upon waking my face is puffy, red & blotchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/31/2021,02/01/2021,1.0,UNK,Synthoid .88 for Hashimoto's Vitamin D 5000 Probiotic,"no illness Shingrix dose 1 vaccine = Tues, Jan 12 2021",Hashimoto's hypothryodism,,very sensitive to various products,"['Erythema', 'Face oedema', 'Pruritus', 'Rash', 'Rash macular']",1,MODERNA,SYR 994015,AL,77.0,M,Cardiac arrest of unknown etiology. Sudden collapse with PEA requiring CPR and intubation. Now has severe anoxic encephalopathy and expect death.,Not Reported,,Yes,Yes,5.0,Not Reported,N,01/26/2021,01/28/2021,2.0,PVT,"Pravastatin 20mg daily, omeprazole 40mg daily, lisinopril 10 mg daily, glimepiride 2 mg daily, donepezil 10 mg QHS, fish oil, niacin 100mg daily, Vit C 500mg daily, Vit E, multivitamin",,"DM type 2, HTN, dementia, hyperlipidemia",,NKDA,"['Blood bicarbonate increased', 'Blood pH increased', 'Cardiac arrest', 'Endotracheal intubation', 'Hypoxic-ischaemic encephalopathy', 'PCO2 increased', 'PO2 abnormal', 'Pulseless electrical activity', 'Resuscitation', 'Syncope']",1,MODERNA,IM 994016,KY,87.0,F,"Found confused, vomited, admitted and dx with ICH.",Not Reported,,Yes,Yes,,Not Reported,N,01/30/2021,02/01/2021,2.0,PVT,,None reported,age related,,"Cipro, Prolia, Sulfa antibiotoics","['Cerebral haemorrhage', 'Confusional state', 'Vomiting']",1,PFIZER\BIONTECH,IM 994017,MD,44.0,F,Rash at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,02/02/2021,10.0,PUB,None,None,Asthma,,None,['Injection site rash'],1,MODERNA, 994018,MD,72.0,M,"Sore shoulder, bicep sore, pain with movements",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/20/2021,1.0,PVT,"Vitamin Losartan , 50mg 2x Metoprolol, 50mg2x Cialis, 5mg, 1x Fenofibrate, 145mg,1x",,high blood pressure Cardiovascular,,stayins,"['Arthralgia', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 994019,MI,38.0,M,pain at the injection site the next day. it was not bad and was gone by the 3rd day,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/19/2021,01/20/2021,1.0,UNK,,,,,,['Injection site pain'],UNK,PFIZER\BIONTECH, 994020,CA,46.0,F,Period very very late for jam and just dark brown spotting very end of jan beginning of feb. unusual,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/16/2021,01/01/2021,,UNK,Effexor 5mg,None,None,,None known,['Macule'],UNK,MODERNA, 994021,WI,24.0,M,"Moderna COVID-19 Vaccine EUA Hives Rash on hands and feet, severe itching and irritation, along with pain. Currently lasting more than 3 days but seems to be winding down on the third day",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/30/2021,9.0,MIL,500mg Vitamin C taken nightly 100mg Vitamin D taken nightly 25mg Melationin taken nightly,,,,None at this time,"['Pain', 'Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 994022,,25.0,F,"Day 6, developed large local reaction w/ erythema, swelling, tenderness. Splotchy, 10cm x 5cm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/31/2021,6.0,MIL,Birth control pill,UTI,,,Sulfa,"['Erythema', 'Local reaction', 'Pigmentation disorder', 'Swelling', 'Tenderness']",1,MODERNA,IM 994023,WI,59.0,F,"Patient received immunization from vial containing diluent in the amount of 1.0 rather than 1.8 ml 0.9% sodium chloride, so dose was concentrated.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,PVT,,,,,"Saccharin, Nickel",['Product preparation error'],UNK,PFIZER\BIONTECH,IM 994024,NY,60.0,F,"2nd dose received 8am 1/27. Fever, 102.1 and severe headache 1/28, 12 am. Developed Shingles 1/28, 10 pm. Shingles lesions continue to develop at the time of this report, despite starting Valtrex 1/29 am",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/29/2021,2.0,PVT,Effexor 225 mg daily.,None,Depression. No other medical history,,Morphine: Hives,"['Headache', 'Herpes zoster', 'Pyrexia']",2,MODERNA,IM 994025,,38.0,F,"Flushing, hives, tachycardia, diaphoresis to 140s within 3 minutes of vaccine. At vaccination site, blood pressure 104/60, slightly lower than normal blood pressure. At vaccination site, patient was given 25 mg Benadryl IM. HR started going down about 15 minutes after Benadryl. HR went down to 90s upon arrival to the ED. HR is normally in the 60s. No further treatment in the ED. Patient did experience fever up to 101 and malaise for 3 days after vaccine. Along with pain at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,MIL,"Zyrtec, Flonase",No,Migraines,,IV contrast - anaphylactic reaction,"['Blood pressure abnormal', 'Flushing', 'Hyperhidrosis', 'Injection site pain', 'Malaise', 'Pyrexia', 'Tachycardia', 'Urticaria']",1,MODERNA,IM 994081,NC,87.0,M,"Fell; Weakness in legs; got so weak; His legs just continued to get worse/He could not get up without help; He could not walk; This is a spontaneous report from a contactable nurse reported for her father. An 87-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, intramuscular on left arm on 13Jan2021 (Time the vaccination was given: 13:00-13:15) at the age of 87-years-old at single dose for prevention because of age group. Medical history included covid-19 in Jun2020, forgetful from an unknown date, he got a little forgetful sometimes, so he may have forgotten to tell her. This occurred prior to getting the vaccine. The patient's concomitant medications were not reported. Prior Vaccinations (within 4 weeks) was none. Family medical history was none. The patient got the Pfizer COVID vaccine last week on 13Jan2021, he was really sick in Jan2021. The patient had weak legs anyway, but he got so weak. Weakness in legs started at night on 13Jan2021, around 20:00. No emergency room (ER) or physician's office required. He never complained of any symptoms and did not know if there were other symptoms, because he did not complain. He fell on Thursday night on 14Jan2021. He got the vaccine around 1:00-1:15pm, and got so weak, that he went to the bathroom and he fell in the floor. His legs just continued to get worse. It started on Wednesday night on 13Jan2021. He could not walk in Jan2021. Thursday was the worst. By Friday, it started to get better. He did not get hospitalized. He could not get up without help. The patient had Covid 19 in Jun2020. He had a lot of symptoms after receiving the first dose of the vaccine. The reporter reported her father fell in the bathroom while brushing his teeth and her brother had to come over to get him up. The reporter was starting to wonder if he should take the second dose. The outcome of the events Weakness in legs and fell was resolving and of the other events was unknown. The reporter considered event Weakness in legs was serious due to medically significant and disabling; considered event fall was serious due to medically significant.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of the events muscular weakness, fall and gait disturbance cannot be excluded. The events are confounded by the elderly patient's underlying conditions. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/13/2021,01/01/2021,,PUB,,,Medical History/Concurrent Conditions: COVID-19; Forgetfulness,,,"['Asthenia', 'Dysstasia', 'Fall', 'Gait inability', 'Malaise', 'Muscular weakness']",1,PFIZER\BIONTECH,OT 994082,GA,56.0,F,"Shingles rash; did have lethargy and was dragging; did have lethargy and was dragging; This is a spontaneous report from a contactable healthcare professional reporting for self. This 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via intramuscular on 11Jan2021 at left deltoid at single dose for COVID Prevention. Medical history and concomitant medications were none. Her health had improved over the last six months and she was on no medications, and her labs had been good. The patient previously received first dose of BNT162B2 (lot number: EJ1685) via IM injection into the left deltoid on 23Dec2020 at single dose for COVID Prevention. She stated that she may have had some dragging after the first dose, but it was after the holidays and she was laying around anyway, so if she did, it was not of note to her at the time. She confirmed that she received no other vaccines on the same day as either her first dose, nor her second dose of the vaccine. The patient experienced shingles rash starting on 14Jan2021. It was reported that the patient received her second dose of vaccine last Monday (11Jan2021). The Thursday following that (14Jan2021), she noticed a small patch of a rash on her right side, and she did not think much of it at first, because she had been gardening. But she stated that by Friday, it was clear that she had the initial onslaught of Shingles. She stated that over the weekend, the rash had taken a very predicable course, where it is now in circles around her body. She had had no other sentinel events, she had not been sick, she was not stressed, the only thing was that four days prior to the rash, she got the last COVID shot. She just wanted there to be accuracy in known side effects because she was 56 years old, but she was not immunosuppressed at all, and she knew that it would be given to people 65 and older soon. Patient stated that she was no sick as a dog, but two days after receiving the second dose, she did have lethargy and was dragging on 14Jan2021. She thought after the second dose, the vaccine may have hit her immune system. The outcome of shingles rash was not recovered and reported as worsened, outcome of other events was unknown. The reporter considered the event shingles rash was serious as medically significant and was related to the vaccine.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of shingles rash cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021092332 same patient/drug, different event separated with time",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/14/2021,3.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Herpes zoster', 'Laboratory test normal', 'Lethargy', 'Rash']",2,PFIZER\BIONTECH,OT 994083,,,M,"Tested positive for COVID 19/headache/chills/coughing; Tested positive for COVID 19/headache/chills/coughing; Dizziness; joint pain all over the body; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients (himself and wife). This is report 1 of 2. A male patient of an unspecified age received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache, dizziness, joint pain all over the body and chills, coughing on 17Jan2021. Patient was trying to figure out for a lot of the symptoms how long does it last. His symptoms started 17Jan2021 morning. The second dose for patient is scheduled on 02Feb2021. The patient was tested positive for COVID 19 on Wednesday, 20Jan2021. He stated he reported a few days ago about some symptoms they had. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021056973 similar report from same reporter",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/17/2021,5.0,UNK,,,,,,"['Adverse event', 'Arthralgia', 'Chills', 'Cough', 'Dizziness', 'Headache', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 994084,,,F,"received first dose of Pfizer COVID vaccine then tested positive for COVID 19/Headache/Chills; received first dose of Pfizer COVID vaccine then tested positive for COVID 19/Headache/Chills; Dizziness; Joint pain all over the body; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported similar events for 2 patients (himself and wife). This is report 2 of 2, the report for the wife. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced headache, dizziness, joint pain all over the body and chills on 14Jan2021. The reporter himself and his wife got the shot on Tuesday the past week (12Jan2021), he was trying to figure out for a lot of the symptoms how long does it last, like the headache, dizziness, both him and his wife were experiencing this. His wife's symptoms began on Thursday 14Jan2021, she started getting sick with joint pain all over the body and chills. The second dose for both of them was scheduled on 02Feb2021. The patient then tested positive for COVID 19 on Wednesday, 20Jan2021. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021056969 similar report from same reporter",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/14/2021,2.0,UNK,,,,,,"['Arthralgia', 'Chills', 'Dizziness', 'Headache', 'Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 994093,PA,37.0,F,"approx. 1 hour following inject experienced severe head ache with blurred vision; approx. 10 days following injection large swelling, redness, and warmth at injection site, appears like muscle swelling to size/shape of an egg",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/23/2021,9.0,PUB,"multivitamin daily, Nexplanon birth control implant",none,none,,none,"['Headache', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Muscle swelling', 'Vision blurred']",1,MODERNA,IM 994094,FL,40.0,F,"Approximately 18 hours after dose I experienced a quick onset of severe fatigue (i.e. hard to get out of bed), chills & mild fever (100F). Additionally, my arm was mildly swollen, warm & very painful. Symptoms lasted for about 10 hours and then quickly disappeared. Tx: Tylenol 100mg .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,PVT,"Claritin 10mg daily, Zoloft 50mg daily, Singulair 10mg daily, fish oil, B complex, Vitamin C & D",None,Environmental allergies Anxiety Migraines,,Doxycline,"['Chills', 'Fatigue', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Skin warm']",2,MODERNA,IM 994095,VA,57.0,F,"Patient self reported through our clinic ADR reporting system. Unsure if they also self reported via VERS. Per report ""Day # 6 after getting 1st Moderna vaccine, I developed enlarged left clavical lymph node that is still the same size now on day #15""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/13/2021,6.0,WRK,,,,,NKDA,['Lymph node abscess'],1,MODERNA,IM 994096,WI,54.0,M,"Patient received immunization from vial containing diluent in the amount of 1.0 rather than 1.8 ml 0.9% sodium chloride, so dose was concentrated.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,PVT,,,,,,['Incorrect dose administered'],UNK,PFIZER\BIONTECH, 994097,FL,68.0,F,Bells Palsy on left side of the face,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/17/2021,8.0,OTH,Amlodopine 10 mg - once daily Metformin 1000 mg - twice daily,None,Diabetes High Blood Pressure,,None,['Facial paralysis'],1,MODERNA,SYR 994098,PA,28.0,F,Extreme muscle and body aches Fever - 101 Chills Migraine Loss of appetite Nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,OTH,Triprevafim - Birth-control Vitamin D Elderberry Capsule,Tested Positive for Covid 19 - 10/20/2020 at 5:16 PM - Sick for the full 14 days,,,,"['Chills', 'Decreased appetite', 'Migraine', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,IM 994099,OH,40.0,F,"Intensive vomiting all night after receiving the vaccine, fatigue, chills, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,PVT,Birth control Tylenol,None,None - I am healthly,,None,"['Chills', 'Fatigue', 'Myalgia', 'Vomiting']",2,MODERNA,SYR 994100,AL,43.0,F,Racing pulse and High blood pressure,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,OTH,"Depo-provers, daily vitamin",None,Mitral valve prolapse,,None,"['Electrocardiogram', 'Heart rate increased', 'Hypertension', 'X-ray']",1,PFIZER\BIONTECH,SYR 994101,CT,59.0,F,9 days after the injection I noticed two red splotches at injection shot. It was very red and hot. This was not there before. I checked the injection site closely 48 hours after the injection was given. I am able to complete my duties at work at a slow pace.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/31/2021,9.0,PVT,,No,Osteoporosis. No lymph nodes in the left armpit.,,Tetanus shot. Blue cheese,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,SYR 994102,IN,26.0,F,"Itchy neck, head, back and knees. Was released to go home and take Benadryl. Headache later that night into Sunday and Monday. Chills and muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/30/2021,0.0,PVT,Yes,None,None,,"Food, and latex","['Chills', 'Headache', 'Myalgia', 'Pruritus']",UNK,PFIZER\BIONTECH, 994103,TN,36.0,F,"Facial flushing that was more prominent on the left side of my face and left ear flushing and burning, dizziness, nausea., and rapid pounding heart beat. This started 45 minutes after receiving the vaccine. About 1 1/2 hours symptoms still persisted so took 50mg of Benadryl and slept for 2 hours. Upon waking up facial flushing, dizziness, and pounding heart rate still present but was better. Continued to have left sided cluster headache and face flushing for 48 hours. Also was sore in my left arm down my left side to the bottom of my rib cage all the way up my left neck and sore into my left chest.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PUB,"Nexium, Lisinopril, Zoloft, Gabapentin, Multivitamin, Probiotic",None,"Type 1 Diabetes, Hashimotos induced hypothyroidism",,None,"['Cluster headache', 'Dizziness', 'Ear discomfort', 'Flushing', 'Heart rate increased', 'Musculoskeletal chest pain', 'Nausea', 'Neck pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH,IM 994104,FL,34.0,M,"Low grade fever, chills and fatigue - 600mg ibuprofen - resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/28/2021,1.0,UNK,None,None,None,,None,"['Chills', 'Fatigue', 'Pyrexia']",2,MODERNA,IM 994105,,35.0,F,"Patient given first dose of Pfizer Covid vaccine. Upon administration felt burning at the injection site. patient then stated she felt tingling in her hands, feet, and mouth. Patient also stated that she felt her heart racing. BP 172/103, HR 149, SPO2 100% on room air. Denies SOB and difficulty breathing. Pt was transferred to ED. In ED was given oral prednisone and diphenhydramine. Assessment for possible drug reaction, not thought to be anaphylaxis, with mild anxiety contributing. Patient monitored and discharged in stable condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PVT,,,,,none,"['Anxiety', 'Injection site pain', 'Palpitations', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 994106,MD,35.0,F,Got the vaccine at 5:03 waited in the clinic for 15 min and left at about 5:27 started feeling throat swelling and numbness in my right side of the face. Got home at 5:35 called a Doctor and He told me to take Benadryl 50mg. Took it and 5-6 min I felt the swelling went down.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PUB,No Medication,none,none,,None known,"['Hypoaesthesia', 'Pharyngeal swelling']",1,MODERNA,IM 994107,FL,83.0,M,"On 1/26/2021, resident had an elevated blood pressure of 183/102 and he was cold and clammy. Resident sent to ER via 911. He was sent home that same day. On 1/27/2021, resident found sitting in his apartment with a facial droop, slightly slurred speech and left sided weakness. Resident had also fallen the previous night and on the morning of 1/27/2021. Resident transported to the ER for evaluation and treatment and was admitted with diagnosis of TIA; rule out stroke.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/19/2021,01/26/2021,7.0,SEN,Heart strong dietary supplement 420mg once a week; zzzquil-diphenhydramine HCL 25mg every night; Probiotics 15mg XL once a week;,None,Prostate Cancer; Breast Cancer,,NKA,"['Blood pressure increased', 'Cold sweat', 'Computerised tomogram head', 'Dysarthria', 'Facial paralysis', 'Fall', 'Hemiparesis', 'Hypertension', 'Transient ischaemic attack']",1,PFIZER\BIONTECH,IM 994109,MI,27.0,M,Body aches 1 day,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/22/2021,01/23/2021,1.0,PUB,,,,,,['Pain'],1,MODERNA,IM 994110,WI,60.0,M,"Patient received immunization from vial containing diluent in the amount of 1.0 rather than 1.8 ml 0.9% sodium chloride, so dose was concentrated.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/01/2021,02/01/2021,0.0,PVT,,,,,,['Product preparation issue'],UNK,PFIZER\BIONTECH,IM 994111,KY,74.0,F,"Cant get her breath, intensely weak, chills.",Not Reported,,Yes,Yes,,Not Reported,N,,01/21/2021,,PVT,"Tylenol, Norvasc, Lipitor, Celexa, Calcium, Vitamin D2 Ferrous Sulfate, Flonase, zestoretic, Claritin, Relafen, protonix, synthroid",,"HTN, GERD, Diverticulosis, hypothyroidism, chronic back pain, osteoporosis, anxiety",,"Azithromycin, Sulfa antibiotics","['Asthenia', 'Chest X-ray abnormal', 'Chills', 'Dyspnoea', 'Lung opacity', 'Oxygen saturation', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 994112,MN,35.0,F,For 10 days I experienced reynauds syndrome in my hands and feet. Terrible painful touch sensations as well. 8/10 pain. Then it resolved. I received my second dose yesterday. So far I just feel like every bone in my body hurts and I feel like I have rabdo.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,OTH,Lisinopril,Had covid oct 4th,None,,"Penicillin, celphlasporins","['Bone pain', 'Pain', ""Raynaud's phenomenon""]",1,PFIZER\BIONTECH,IM 994113,MN,82.0,F,Daughter contacted the clinical location for vaccination to inquire regarding if her mother was confused when at the location to receive her vaccine as she ended up in the ED 2 hours later with a diagnosis of stroke. completing VAERs due to how closely the vaccine was to the event.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/28/2021,01/28/2021,0.0,PVT,Aspirin Plavix Lipitor Neurontin Hydrodiuril,obstructive sleep apnea HTN Arthritis Hyperthyroidism Urinary urge incontinence Hyperlipidemia Prediabetes Malignant melanoma of the face,obstructive sleep apnea HTN Arthritis Hyperthyroidism Urinary urge incontinence Hyperlipidemia Prediabetes Malignant melanoma of the face,,no known allergies,"['Cerebrovascular accident', 'Confusional state']",1,PFIZER\BIONTECH,IM 994114,IA,40.0,F,"Vomiting, diarrhea, fever, generalized intense pain. Fatigue still experiencing at this time",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,SEN,,UTI,,COVID vaccine 1st dose,"PCN, bee stings","['Diarrhoea', 'Fatigue', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 994115,NY,65.0,F,"One week later injection site is red, warm, swollen and itching",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/02/2021,8.0,PHM,"Lipitor, lisinopril, estradiol Vitamin C, D, B50, fish oil, calcium, echinacea, folic acid, fiber supplement",None,"Hypertension, high cholesterol and diabetes",,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA, 994116,MO,60.0,F,"Rash raised, red, warm, and itchy in area covering about 7 cm underneath injection site. This started on Feb. 2. Also had fever of 100 degrees, body aches, headache for about 36 hours, it started 12 hours after I received the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/01/2021,2.0,PHM,"Eliquis, Metoprolol, and Centrum multi vitamin",None,Prehypertension,,Ciprofloxin allergy,"['Headache', 'Injection site rash', 'Pain', 'Pyrexia', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",2,PFIZER\BIONTECH,IM 994117,NC,22.0,F,"vomiting, 100 degree fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/02/2021,1.0,PVT,celexa 20MG,none,asthma,,trintellix,"['Pyrexia', 'Vomiting']",2,MODERNA,IM 994119,MI,35.0,F,Lips double in size,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/01/2021,3.0,UNK,Escitalopram,Allergic reactions to first dose,No,,Allergies to a lot,['Lip swelling'],UNK,PFIZER\BIONTECH, 994120,IL,59.0,F,"On the 8th day the injection site became blotchy, red & itchy. On day 9 the site was solid red and warm to the touch. On day 10 the redness was gone, but the itch remained until day 12.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/29/2021,8.0,PVT,Vitamin D,None,GERD & allergies that cause sinus congestion,"10/2020, 2nd dose of shingles, soreness, tired, slight fever lingered for approx 48 hours","Environmental allergies, e.g., pollen, trees, dust, cats, etc.","['Injection site erythema', 'Injection site pruritus', 'Injection site warmth', 'Rash macular']",UNK,MODERNA, 994121,IL,74.0,M,"Abdominal cramps, followed by diarrhea that lasted 8-12 hours. Reporting this because I don't see it among listed common side effects. Other family member shared same food and had no symptoms Do have mild site discomfort and probable axillary lymphadenopathy but see that these are not uncommon",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/01/2021,02/01/2021,0.0,PVT,"Losartin/ HCT, Amlodipine",none,hypertension,,"sulfa, ace inhibitors","['Abdominal pain', 'Diarrhoea', 'Injection site discomfort', 'Lymphadenopathy']",2,MODERNA,IM 994122,OH,50.0,M,Residual pain in his arm pit- radiates to his neck and radiates down his arm to elbow,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,PVT,,,Hx of HTN,,,"['Axillary pain', 'Neck pain']",2,MODERNA,IM 994123,IN,37.0,F,"5:15 Mucus in throat, given water and swallowing okay, breathing okay HR 84, R 20 5:30 Swallowing remains okay. Has medicine taste 5:45 BP 120/90, HR 80, R 20 Instructed to call 911 at discharge for any throat or breathing issues",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PVT,none,none,none,,none,['Dysgeusia'],1,MODERNA,IM 994124,MO,60.0,F,"fever up to 102.4 day following vaccine for approx. 28 hours, joint pain, severe headache with the fever. On the 30th 3 days after vaccine 4 large fever blisters appeared. On the 31st sores inside mouth and on tongue, feels like I burned my mouth. On 2/1 my lips started peeling as if they had been burned. Today my lips are still peeling and the fever blisters have started to crust over.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/28/2021,1.0,WRK,"Ibuprophen, Pepcid, Lipitor, Vitamin C, Resurge sleeping aide, multivitamin with minerals",none,hyperlipidemia,,none,"['Arthralgia', 'Headache', 'Lip exfoliation', 'Oral discomfort', 'Oral herpes', 'Pyrexia', 'Scab', 'Stomatitis', 'Tongue ulceration']",2,MODERNA, 994125,MA,43.0,F,"In addition to some of the expected symptoms (arm soreness, chills, headache) I experienced the most debilitating sciatica pain from 18-36 hours post shot. I thought my back condition was worsening but honestly think it was an effect. Nothing I had been using for pain relief helped. I was in agony during that period. Agitated. At 5AM on 1/29/21, I woke up soaked in sweat and finally had some pain relief. From that point on, my pain returned to my normal level. I never reported this to any healthcare professional since at the time, I did not think this pain was related (also not sure what could have been done).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/28/2021,1.0,PUB,Florajen 3 Probiotic taken about 7 hours after vaccine Aleve taken about 16 hours after vaccine,Sciatica pain from a herniated disk / impinged nerve,"Asthma, IBS, environmental allergies",,Shellfish,"['Agitation', 'Chills', 'Headache', 'Hyperhidrosis', 'Pain', 'Pain in extremity', 'Sciatica']",2,MODERNA,IM 994126,LA,77.0,F,"7inx9in erythema around injection site, localized reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,PUB,"Lasix 20mg daily, Plavix 75mg daily, Rosuvastatin Calcium 20mg daily",,,,"Valium, Cefdinir, Levofloxacin",['Injection site erythema'],1,MODERNA,IM 994127,WI,76.0,M,"I woke in the night on Monday, Feb. 1 to use the bathroom and when I stepped out of bed I felt a sharp pain in the outside ball of my right foot. I thought I had stepped on a needle. I could not step on that side of the foot as I walked without sharp pain. I immediately searched for what might be in my foot and found nothing. The pain continued through the night and into the morning. My shot was in the left shoulder. I have concluded this is a neurological reaction (nerve pain) from the vaccine (Moderna). Never had this pain before.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,02/01/2021,3.0,UNK,"glaucoma meds., cholesteol med., floxmax",none,"glaucoma, hypertension",,"nickel, msg, mold, pollen, vicodin","['Gait disturbance', 'Neuralgia', 'Pain in extremity']",UNK,MODERNA, 994128,MA,65.0,F,"Within 5 minutes of receiving vaccine developed itchy, tightening throat, constant need to clear throat, cough, hoarseness, back redness. Received 25 mg IV Benadryl with relief of symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,PVT,Biotin Singulair Escitalopram Senior vitamin Vision Formula 50 Vitamin D3 Zyrtec,none,Asthma,,Forteo Compazine Erythromycin,"['Cough', 'Dysphonia', 'Erythema', 'Pruritus', 'Throat tightness']",2,MODERNA,IM 994129,NJ,45.0,F,"Arm pain started 1/28 lasted 4 days Swollen and painful lymph nodes, left armpit, left supraclavicular, also in groin -started 1/29/21- still happening Abdominal pain and diarrhea on 1/30/21 Spleen swelling/swelling just below left rib front and back and pain started and no appetite 1/31/21- still happening",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,PUB,Magnesium glycine Colace,Tmj,,,Reglan,"['Abdominal pain', 'Decreased appetite', 'Diarrhoea', 'Lymph node pain', 'Lymphadenopathy', 'Pain in extremity', 'Spleen disorder']",2,MODERNA,IM 994130,,49.0,F,Sustained laceration on head from feeling lightheaded with presyncopal episode.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/26/2021,1.0,PVT,,,,,,"['Dizziness', 'Presyncope', 'Skin laceration']",2,MODERNA,IM 994131,NY,39.0,F,Reported feeling achy and fever of 101.2F.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/28/2021,01/28/2021,0.0,PVT,,,,,,"['Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 994132,MI,50.0,F,"Hands have turned blue on two occasions for 6-7 hours. Occurring 19 days and 24 days after vaccine. Phone contact made with nurse at doctor's office, after first occurrence, who advised no appointment necessary and to continue to monitor. Last occurrence was yesterday 2/1/20 in the evening, which has now resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/28/2021,20.0,PUB,Adderall Klonopin Escitalopram Gabapentin Lisinopril Flonase Ceterizine Singulair Daily Vitamin Iron supplement Vitamin D supplement,,hypertension hyperlipidemia depression anxiety ADHD Fibromyalgia Environmental allergies,,codeine zofran,['Skin discolouration'],1,MODERNA,SYR 994133,MA,38.0,F,"Dose 1: 1/4/2021 Soreness at injection site within 6 hrs that resolved after 48 hrs, one week later swollen armpit and discomfort in the same injected arm that went away after approximately 48 hrs Dose 2: 2/1/2021 Soreness at injection site within 4 hrs, chills and generalized malaise and head ache that same night and sore throat, stuffiness that is ongoing at 24 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Chills', 'Headache', 'Injection site pain', 'Malaise', 'Oropharyngeal pain', 'Respiratory tract congestion']",2,MODERNA,IM 994134,NY,42.0,F,"I am going to describe all my symptoms so far in detail. Shortly after the shot in the medical observation area I experienced mild nausea that went away for the rest of the day. About an hour after the injection, I experienced nasal drainage in the back of my throat that lasted about 30 minutes. 3 hours after my shot, the arm pain at injection site began, followed by 6 hours later moderate to extreme fatigue that did not cause me to be sleepy or drowsy--simply fatigued. I had enhanced sense of taste and smell. On Wednesday, 1/27 I woke up seeming okay and tried to work at my computer from home. I experienced light-headed and dizziness, and a headache that feels like pressure, and sinus pressure at the bridge of my nose. I had to disengage from work. After lunch around 2 PM I had extreme fatigue and had to lie down in bed the rest of the afternoon and evening. I have moderate nausea that comes in goes in waves. This morning, Wednesday, 1/28 I woke up with nausea and ate breakfast with a heightened sense of smell and taste. I logged into work and the lightheadedness and dizziness began again (also sort of in waves, though the headache is more pervasive and less wave-like than the nausea), along with waves of moderate nausea and headache. The arm pain at the sight of injection has significantly abated from a punch to mild pain. The ""sinus"" or sinus pressure on the bridge of my nose seems only a fraction improved. The headache or pressure has moved from the back of my head to the right side of my head. I had no body aches, but this morning has mild to moderate body aches this morning in my legs and hip bones. 1/29 I woke up with 20%-30% reduced symptoms of nausea and headache, but the dizziness and sinus pressure on the bridge of my nose remain the same. I still have enhanced taste and smell (a sensory plus it's not a distorted or odd enhancement, simply the same flavors and tastes enhanced). The ache that began yesterday in my lower body, my legs still ache, though it feels more like numbness than an ache. I tried doing some stretches which felt good, but my legs still feel the same after stretching. Pain at the site of injection is reduced 90%. There are some strawberries sitting next to me, and I can smell them acutely. Yesterday, 1/30, I woke up with mild nausea and fatigue. This nausea dissipated in the morning, but I felt too fatigued to do Pilates. The waves of dizziness and waves of nausea returned mid-day and I had a low-grade fever of 99.4 (my temp. Tends to run slightly lower than 98.6, as I take it regularly). The pain/pressure in the bridge of my nose has reduced 30%, but still remains. The ache or numbness in my thighs remains the same. This morning, 1/31, my temp is normal at 98.6, but I have mild waves of nausea and moderate waves of dizziness. The pain/pressure on my nose remains the same as yesterday. I have some mild ear pressure. My thigh weakness remains the same. I am too fatigued to attempt Pilates. Acute sense of smell and taste remains the same. The headaches or pressure also seem improved since Saturday 1/30. Monday, 02/01 - ah back to work I woke up with moderate nausea and pretty intense body fatigue and muscle aches in my lower body. I had to work, and I just wanted to crawl back into bed. I worked anyway, also the fatigue tends to worsen mid-day. The dizziness is moderate in waves, and the headache is still mild, along with that mild sinus pressure on my nose. I was in bed after dinner but could have rested all day. 02/02 I awoke with a very mild nausea! The intense fatigue (which worsened several days past my vaccine) was mild. I was ready to attempt my regular Pilates routine, and I did it! My muscle aches are mild to moderate (also, why are my muscle aches mostly confined to my thighs and hips I do have vague pain at the injection site, but its vague, and I use my whole body in Pilates) dizziness waves are back as I sit here typing and get ready to login online to my job staring at the computer screen is jarring to the dizziness waves and reminds me of the mild headache. This is the best I've felt since 1/27 through mid-day I tend to worsen and dizziness that is moderate is disturbing. The heightened sense of taste and smell also seems to have waned a bit in the past two days, back to what I was per usual? I tend to have an acute sense of smell and taste. *I would like it noted in light of new evidence that many people that have had COVID are experiencing intense reactions to the first dose that it is quite likely that I had COVID back in March when my learning center (I work with students age 4-adult, some of which are learning disabled and have autism) emergency closed because a client called to say she was positive for COVID. I had taken her sons temperature the day before. Me, and my two co-workers on my management team were also feeling sick. I had a sore throat and chest pains for approx. a month, but at the time COVID testing was not widely available. Since then, My co-worker has tested positive twice for the antibodies, and her husband, who was also sick at the same time, has tested negative twice. I tested negative once for the antibodies, though given my job, my commute on the subway during rush hour my co-workers positivity, and my intense reaction to the first dose I most likely had COVID. My boyfriend's roommate recently also revealed that he is positive to the antibodies, and he was literally sneezing and coughing in the same room with us this past summer and spring. I think a 2nd dose of the same vaccine will cause fainting and vomiting, and the need for two weeks off of my work. This dizziness is alarming. I'm also thinking not having antibodies means nothing in terms of my body and immune system recognizing the vaccine and the virus, making me more ill than when and if I actually had COVID in March or last year.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,PUB,None,None,Teenage Asthma I grew out of years ago.,,"Penicillin, mango skin, dust mites","['Dizziness', 'Ear discomfort', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Paranasal sinus discomfort', 'Parosmia', 'Pyrexia', 'Taste disorder', 'Upper-airway cough syndrome']",1,PFIZER\BIONTECH,SYR 994135,CA,38.0,F,"I am 38 years old with no history of medical problems. I do NOT have a history of miscarriages and have one healthy child who is 22 months old. On 1/13/21, I took a home pregnancy test which came back positive. At that time, I had a missed period but also had several common pregnancy symptoms such as bloating, acne, fatigue and tender breast. later that week, I called OB/Gyn and spoke to an RN to schedule my 8/9 week ultrasound and to inquiry about the vaccine during pregnancy since I had no clue whether it was recommended/safe or not. the RN, very confident and without any disclaimer, stated that hospital is recommending all of their pregnant patients to receive the vaccine. Obviously, I decided to trust this medical professional who was so confident in her response. My normal pregnancy symptoms continued. On 1/19/21, I was 5 weeks pregnant and received my first dosage of the vaccine. felt fine other than a sore left arm. on 1/20/21, I woke up with a lot of abdominal cramping and pain. It was new to me but assumed it was normal. My cramping and pain continued until 1/21/21. On 1/21/21, I woke up without the cramping and pain. But, I also noticed that my breast were no longer tender and my skin had completely cleared up. I became concerned but prayed everything was fine since my home pregnancy test was still positive. On 1/22/21, by cramps continued once again but more mild. My pregnancy symptoms seemed as if they were no longer present but remained hopeful. On 1/23/21, I woke up with light spotting that only lasted through the morning. Soon after, I started having extreme abdominal pains. I prayed everything was fine. The pain continued and became worse. That night, the pain was so bad that I just went to bed. Right before going to bed, I noticed I had started spotting again. A little heavier than in the morning. I made sure to lay on my left side, hoping it was normal in pregnancy. On 1/24/21, I woke up with heavy bleeding and clotting. I went to the doctor and got an ultrasound and blood test. I was told by the doctor at Hospital that I had a miscarriage.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/20/2021,1.0,OTH,Prenatal Vitamins,None,None,,None,"['Abdominal pain', 'Abortion spontaneous', 'Blood test', 'Exposure during pregnancy', 'Pain in extremity', 'Pregnancy test positive', 'Thrombosis', 'Ultrasound scan abnormal', 'Vaginal haemorrhage']",1,MODERNA,SYR 994137,NC,29.0,F,"Because of patient's previous reaction, pt premedicated with famotidine 20 mg, benadryl 25 mg, ibuprofen 400 mg 30 min before injection. Received vaccine at 9:15 AM. She initially felt well, but about 20-30 minutes after administration began to feel dizzy. Then had nausea, vomiting, dizziness, severe headache, feeling of her body being heavy, arm pain at site of administration. Vitals were monitored/stable throughout. Pt was given Zofran 4 mg disintegrating tab at 9:50, which did not do much to relieve sx. However, at 10:35 she noted that headache was gone, although still had dizziness, arm pain. By 11:08 no longer had symptoms except for arm pain. By 11:43 still feeling back to normal except for arm pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,PVT,"acyclovir, famotidine, sertraline, multivitamin",Had similar reaction to first dose of Pfizer Covid vaccine,"Hypercholesterolemia, morbid obesity, GERD, depression","First dose given at hospital. Pt had severe side effects after previous COVID vaccine -- had syncope x2 with n/v/dizziness, hea",None,"['Dizziness', 'Headache', 'Injection site pain', 'Limb discomfort', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 994141,,53.0,F,"after vaccine experienced very sore arm couldn't hold anything, body aches and joint pain felt like I had a fever but did not, extreme fatique",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/21/2021,01/22/2021,1.0,PVT,,,,,,"['Arthralgia', 'Fatigue', 'Feeling hot', 'Grip strength decreased', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 994215,CO,57.0,F,"Subconjunctival hemorrhage of right eye due to new onset hypertension; Subconjunctival hemorrhage of right eye due to new onset hypertension; headache; This is a spontaneous report from a contactable Nurse. This nurse reported for self that the 57-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Pfizer, lot number: EK9231, exp date and batch were not reported) via unknown route of administration on 13Jan2021 10:00 AM on Left arm at a single dose for covid-19 immunization. She is not pregnant. Medical history included known allergies: Sulfa (Sulfonamide Antibiotics), Hypothyroidism, Hx Atrial Flutter ablation resolved, Hx Hysterectomy. Concomitant medications included Estradiol, Propranolol, levothyroxine/liothyronine (NP THYROID), Aspirin [acetylsalicylic acid], MVI. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19 Covid-19 mRNA vaccine/Pfizer, lot number: EK5730, exp date and batch were not reported) via unknown route of administration on 23Dec2020 08:00 AM on Right arm at a single dose for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in fourweeks. The patient experienced Subconjuctival hemorrhage of right eye due to new onset hypertension, headache from 13Jan2021 06:00 PM. Ae resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received and started on Lisinopril. No covid prior vaccination. Covid tested post vaccination. The outcome of the event was recovering. Covid test post vaccination included covid test type post vaccination was Nasal Swab, covid test name post vaccination was Covid rapid test on 15Jan2021 with covid test result: Negative. on 17Jan2021, covid test type post vaccination was Nasal Swab, covid test name post vaccination was Covid with covid test result: Negative.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events conjunctival haemorrhage and hypertension cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/13/2021,0.0,PVT,ESTRADIOL; PROPRANOLOL; NP THYROID; ASPIRIN [ACETYLSALICYLIC ACID],,"Medical History/Concurrent Conditions: Atrial flutter (other medical history: Hypothyroidism, Hx Atrial Flutter ablation resolved, Hx Hysterectomy); Hypothyroidism (other medical history: Hypothyroidism, Hx Atrial Flutter ablation resolved, Hx Hysterectomy); Hysterectomy (other medical history: Hypothyroidism, Hx Atrial Flutter ablation resolved, Hx Hysterectomy); Sulfonamide allergy (known allergies: Sulfa (Sulfonamide Antibiotics))",,,"['Conjunctival haemorrhage', 'Headache', 'Hypertension', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH, 994216,TX,40.0,F,"Guillain Barre Syndrome; the patient's tongue started to go numb; The initial case was missing the following minimum criteria: Unspecified adverse event. Upon receipt of follow-up information on 18Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from contactable consumers, sibling of the patient and his wife. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. There was no medical history, Family Medical History Relevant to adverse events or concomitant medications. There were no Prior Vaccinations within 4 weeks and no additional vaccines administered on same date of the Pfizer suspect. The sibling of the patient reported the patient had an adverse event after the vaccine that he later described as Guillain Barre. The patient was hospitalized after receiving the COVID vaccine on 08Jan2021. She was admitted to the hospital, the consumer (the sibling's wife) thought, on either 14-15Jan2021. She was not sure of the admitting diagnosis but patient was being treated for Guillain Barre Syndrome. Patient has had a spinal tap on an unspecified date, no results were known. The patient was very healthy, in general the consumer knew she had no typical comorbidities. The reason it was thought to be related was she was perfectly healthy prior and right after she got the vaccine, the patient's tongue started to go numb, that day or the day after (in Jan2021). The events required a visit to Emergency Room, but not to Physician Office. Weight was unknown but the patient was very fit, and BMI (Body mass index) had to be in the normal range. The outcome of the events was unknown.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/08/2021,01/01/2021,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Guillain-Barre syndrome', 'Hypoaesthesia oral', 'Lumbar puncture']",UNK,PFIZER\BIONTECH, 994218,OH,61.0,F,"lost 22lbs; teeth hurting; can't eat; sores in mouth; cold chills; Headache/it's mainly in the back of her head; Diarrhea; Throwing up/threw up 4 times; low grade temp of 100; This is Spontaneous report from a contactable consumer reporting for self. A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration in Right arm on 14Jan2021 10:00 at single dose for covid-19 immunisation. Patient received 1st dose of bnt162b2 on 24Dec2020, Lot number: EL0140; She only had a little aches with the first dose. States that she has had Covid before. There were no concomitant medications. She got the 2nd covid vaccine and felt like she got Covid all over again, diarrhea, throwing up, cold chills, and headaches started on 15Jan2021 at around 2:00AM, low grade temp of 100 on 15Jan2021, then she got sores in her mouth and now her teeth hurt. States that maybe it's from the fever. States that she can't eat because it hurts. She lost 22lbs because she couldn't eat. She has been gargling with half warm water and half peroxide. States that she threw up 4 times, but she doesn't even remember how many times she had diarrhea. After she was done throwing up she finally sat down and took her temperature, so it was probably around 4:00-5:00 AM. States that she still has a headache; it's mainly in the back of her head. Outcome of event diarrhea, throwing up, low grade temp of 100, chills was recovered, of headache was recovering, of can't eat and lost 22lbs was unknown, of others was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/15/2021,1.0,SEN,,,Medical History/Concurrent Conditions: COVID-19,,,"['Chills', 'Diarrhoea', 'Feeding disorder', 'Headache', 'Pain', 'Pyrexia', 'Stomatitis', 'Toothache', 'Vomiting', 'Weight decreased']",2,PFIZER\BIONTECH, 994219,,49.0,M,"Diagnosis of Bell's palsy/ getting peripheral nerve palsy/Left side partial facial paralysis/droopy face; difficulty with blinking; This is a spontaneous report from a non-contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3246), via an unspecified route of administration on 09Jan2021 14:30 at left arm at single dose for covid-19 immunisation. Medical history included type 2 diabetes, Hep B carrier. Concomitant medication included metformin, entecavir. On 17Jan2021 04:30 PM, the patient experienced left side partial facial paralysis, droopy face, difficulty with blinking...went to ER to rule out stroke, MRI and CAT scan normal. Diagnosis of Bell's palsy. First time getting peripheral nerve palsy. AE treatment: Prednisone, Valtrex, eye drops...IV steroids. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. No known allergies. The patient underwent lab tests and procedures which included computerised tomogram: normal, magnetic resonance imaging: normal. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/17/2021,8.0,PUB,METFORMIN; ENTECAVIR,,Medical History/Concurrent Conditions: Hepatitis B carrier; Type 2 diabetes mellitus,,,"['Computerised tomogram normal', 'Corneal reflex decreased', 'Facial paralysis', 'Magnetic resonance imaging normal', 'Peripheral nerve palsy']",1,PFIZER\BIONTECH, 994220,,,F,"decline in her motor functions; she slowed down, weakness in her arms and legs.; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) from a non-contactable consumer reported for a female patient (her sister in law) A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. Medical history included guillain-barre syndrome and autoimmune disorder. The patient's concomitant medications were not reported. The reporter stated that ""wanted to know any data available for covid vaccine use in GBS (Guillain Barre syndrome) and autoimmune disorder. Her sister in law had scopey episode 4 days prior to getting the vaccine and after taking the vaccine she developed decline in her motor functions, she slowed down, weakness in her arms and legs. Patient was hospitalized"". The outcome is unknown and action taken was not applicable. No follow-up attempts are possible; information about lot/batch number cannot be obtained",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Autoimmune disorder; Guillain-Barre syndrome,,,"['Bradykinesia', 'Motor dysfunction', 'Muscular weakness', 'Syncope']",UNK,PFIZER\BIONTECH, 994221,SC,50.0,F,"ALT(alanine aminotransferase) 101; AST (aspartate aminotransferase) levels elevated; This is a spontaneous report from a contactable consumer. A 50-year-old female patient (not pregnant) received the first dose of bnt162b2 (BNT162B2 also Covid 19 vaccine brand Pfizer, lot EL1284), via an unspecified route of administration in the left arm on 29Dec2020 07:00 at SINGLE DOSE for Covid-19 immunisation. He received the vaccine in a hospital. Medical history included menopause and acid reflux. He had allergies to medications, food, or other products: Sulfa, Levaquin, Loestrin Fe. Concomitant medications included methylprednisolone and pantoprazole. On 30Dec2020, his ALT(alanine aminotransferase) and AST (aspartate aminotransferase) levels were elevated. ALT 101 and AST 54 on 30Dec2020. Has reverted back to normal levels ALT 18 on 14Jan2021 AST 20 on 14Jan2021. No treatment given. The outcome of events was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,METHYLPREDNISOLONE; PANTOPRAZOLE,,Medical History/Concurrent Conditions: Acid reflux (esophageal); Menopause; Sulfonamide allergy,,,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased']",1,PFIZER\BIONTECH, 994222,NC,84.0,F,"really sick; In bed 2 days; Could not eat; Hurting all over and joints aching; Hurting all over and joints aching; Fever and really cold; Fever and really cold; Left arm was sore after injection; Left arm was sore after injection and she had a lump and was itching; Left arm sore after injection with lump and itching; This is a spontaneous report from a contactable Nurse reported for mother. An 84-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via intramuscular at arm left on 13Jan2021 13:00 at single dose for prevention because of age group. Medical history included hypothyroid diagnosed many years ago, having Covid in Jun2020. Concomitant medications were unknown. The patient was really sick from an unspecified date. The reporter was starting to wonder if the patient should take the second dose. The patient was in bed for 2 days, could not eat and was hurting all over at 23: 00 on 13Jan2021. Her joints were aching at 23: 00 on 13Jan2021. She had a fever and not really chills, but she just never could get warm and was really cold at 23: 00 on 13Jan2021. She went to bed and woke up on that same date, 13Jan2021, and it started at 11pm. She guessed it was disabling. As it went on, it got better. By Friday, she was finally able to eat. She has plenty of weight to fall back on for not eating. By Friday, she started eating again. She was still not back to normal yet though. She just felt like she could not get up. The fever only went on for a few days. Left arm was sore after injection and she had a lump and was itching 13Jan2021. It worried her. The lump was still itching and sore, but was getting better. Reporter stated that the shingles vaccine did the exact same thing to her with the lump under her skin and itching. It was given on her hip because she had small arm and they were scared to give it in her arm. The reporter wanted to know if there were elderly people in the trial and did any of them have COVID. No additional vaccines administered on same date of the pfizer suspect. Seriousness for In bed 2 days was reported as disabling. Seriousness for Could not eat, Fever and really cold was reported as not serious. Seriousness for Left arm sore after injection with lump and itching was reported as medically significant. Outcome of the events Fever and really cold, really sick was unknown, of other events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/13/2021,01/13/2021,0.0,PUB,,,Medical History/Concurrent Conditions: COVID-19; Hypothyroidism,,,"['Arthralgia', 'Dysstasia', 'Feeding disorder', 'Feeling cold', 'Injection site mass', 'Injection site pain', 'Injection site pruritus', 'Malaise', 'Pain', 'Pyrexia', 'Sleep disorder']",1,PFIZER\BIONTECH,OT 994223,TX,,U,"bilirubin is so high (13); Liver enzymes have increased; bilirubin is so high (13) that patient is now yellow; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 08Jan2021, via an unspecified route of administration as a single dose for COVID-19 immunisation. Medical history included colon cancer with liver METS for which the patient had been treated very well with chemotherapy (unspecified) with no negative effects. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2, on 19Dec2020 via an unspecified route of administration for COVID-19 immunisation. On an unknown date since the vaccine was administered (Dose 1 on 19Dec2020 and 2nd dose 08Jan2021), the patient experienced liver enzymes increased and bilirubin so high (13) that the patient is now yellow. The patient reported that the experts in cancer care are baffled by the cause. The patient inquired if it is possible the vaccine is responsible for elevated enzymes in immunocompromised patients? The clinical outcome of the liver enzymes increased and bilirubin so high that the patient is now yellow was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,,,UNK,,,Medical History/Concurrent Conditions: Chemotherapy (treated very well with chemotherapy with no negative effects.); Colon cancer (treated very well with chemotherapy with no negative effects.); Liver metastases (treated very well with chemotherapy with no negative effects.),,,"['Blood bilirubin increased', 'Hepatic enzyme increased', 'Yellow skin']",2,PFIZER\BIONTECH, 994248,KY,85.0,F,None stated.,Not Reported,,Yes,Yes,,Not Reported,N,01/29/2021,02/02/2021,4.0,PVT,,None listed,,,NKA,['Unevaluable event'],1,PFIZER\BIONTECH,IM 994254,CA,51.0,F,"Systemic: Headache, Systemic: Other- Staff Member complained of metallic taste and headache. Instructed to lay down, BP was elevated, continued to rise. Contacted 911, patient transported to hospital, admitted and disharged next day. Symptoms lasted 1 day",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/28/2021,01/28/2021,0.0,SEN,,,,,,"['Blood pressure increased', 'Dysgeusia', 'Headache']",1,PFIZER\BIONTECH,IM 994261,TN,39.0,M,"Patient received first dose of Moderna Covid Vaccine on 12/28/2020, second dose on 01/27/2021. Treated on 01/31/2021 for abdominal pain and nausea, appendicitis. Patient admitted and taken in for appendectomy.",Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/27/2021,01/31/2021,4.0,PVT,Diovan HCT,None,"Hypertension, Hyperglycemia",,None,"['Abdominal pain', 'Appendicectomy', 'Appendicitis', 'Computerised tomogram abnormal', 'Hepatic steatosis', 'Liver function test increased', 'Nausea']",2,MODERNA, 994265,AR,82.0,F,"got the 2nd vaccine on Thursday and already had symptoms from 1st vaccine but became weaker, vomiting, diarrhea. headache went to the ER Sunday . She was coherent just weak. Did Xray of stomach found out she had colitis , started her on antibiotics and admitted her and by the next morning She started having delusions, almost like having a seizure. on blood work her magnesium was low. She started retaining fluid. Thought maybe she had stroke but CT showed nothing. Now she doesn't know who she is and just repeating numbers. Pt is currently in the ICU. She has a feeding tube now do to not eating.",Not Reported,,Not Reported,Yes,9.0,Not Reported,N,01/20/2021,01/20/2021,0.0,OTH,,,"congestive heart failure, anemic,",,Sulfur,"['Amnesia', 'Asthenia', 'Blood magnesium decreased', 'Blood test', 'Colitis', 'Computerised tomogram', 'Delusion', 'Diarrhoea', 'Diet refusal', 'Electroencephalogram', 'Feeding tube user', 'Fluid retention', 'Headache', 'Intensive care', 'Mental disorder', 'Seizure', 'Vomiting', 'X-ray']",2,PFIZER\BIONTECH,SYR 994309,NY,87.0,M,"Got vaccine on 1/15/21. He was tired right away, bedridden the next 3 days. He couldn't breathe so he was taken by ambulance on 1/18/21. He was in hospital for several days. put on remdesivir cocktail for 10 days. Slowly getting worse and died in hospital on 1/30/21.",Yes,01/30/2021,Not Reported,Yes,13.0,Not Reported,N,01/15/2021,01/16/2021,1.0,PVT,"Amlodipine, 5 mg; Metformin, 500mg (twice a day); Simvastatin, 20mg; Omeprazol Dr, 40mg.",,,,None,"['Bedridden', 'Death', 'Dyspnoea', 'Fatigue']",1,MODERNA, 994325,MO,75.0,M,"ER 27Jan2021 Patient reports nausea and vomiting for 5 days after getting the first dose of the COVID-19 vaccine. DC home after re-hydration and antiemetics given. CT Abd/chest :1. Mild to moderate colonic diverticulosis without evidence for diverticulitis. No bowel obstruction. 2. Patchy basilar atelectasis with worse involvement of the right lowerlobe, superimposed infection not excluded. Additional findings as discussed. Admit to medsurg ward 28 Jan 2021",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/23/2021,01/23/2021,0.0,PVT,,unknown acute hx,"G89.4, N18.30, Z95.810(I50.22),I25.5,G47.3",,"Naproxen, Diazepam","['Atelectasis', 'Blood culture negative', 'Blood lactic acid increased', 'Computerised tomogram abdomen', 'Computerised tomogram abnormal', 'Computerised tomogram thorax', 'Dehydration', 'Diverticulum intestinal', 'Full blood count', 'Mean platelet volume increased', 'Nausea', 'Superinfection', 'Vomiting']",1,PFIZER\BIONTECH,IM 994332,DE,34.0,F,The employee was hospitalized on 1/25/21 and is currently being treated for multiple reasons including IVIG therapy for Guillian Barre.,Not Reported,,Not Reported,Yes,6.0,Not Reported,U,01/12/2021,01/25/2021,13.0,WRK,,,,,,"['Guillain-Barre syndrome', 'Immunoglobulin therapy']",1,PFIZER\BIONTECH,IM 994333,KY,86.0,U,None stated.,Not Reported,,Not Reported,Yes,,Not Reported,N,01/27/2021,02/02/2021,6.0,PVT,,,"COPD, HTN, AAA",,PCN,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 994339,OH,83.0,F,PATIENT RECEIVED COVID-19 VACCINE AND WAS TAKEN BY WHEELCHAIR TO THE OBSERVATION AREA WHERE A PROVIDER AND NURSE WERE OBSERVING FOR ANY ADVERSE REACTIONS. THE PATIENT WAS ADVISED TO WAIT 15 MINUTES BEFORE LEAVING THE FACILITY. THE PROVIDER NOTICED THE PATIENT LEANING FORWARD IN HER WHEEL CHAIR. SHE TRIED TO ENGAGE HER AND SHE WAS UNRESPONSIVE. SHE TRIED TO ALERT HER AND SHE WAS AGAIN UNRESPONSIVE. THE PROVIDER ADVISED NEARBY STAFF TO CALL 911 AND FOR THE NURSE TO BRING THE CRASH CART AND OXYGEN AS SHE ASSESSED THE PATIENT FOR A RADIAL PULSE. NO PULSE WAS PALPABLE. SHE THEN ASSESSED FOR A CAROTID PULSE AND NO PULSE WAS PALPABLE. ANOTHER PROVIDER ARRIVED AND THEY QUICKLY PUSHED THE PATIENT TO THE CLOSEST EXAM ROOM FOR FURTHER ASSESSMENT AND POSSIBLE CPR. VITAL SIGNS WERE BEING OTAINED WHICH REVEALED HYPOTENSIVE. BLOOD GLUCOSE TAKEN AND WAS WITHIN NORMAL LIMITS. AS THEY STARTED TO REMOVE HER CLOTHING TO PREPARE FOR RESUCCITATION SHE BECAME ALERT AND APPEARED ANGRY AND CONFUSED. SHE QUICKLY BECAME ALERT AND ORIENTED. EMT'S ARRIVED AND COLLECTED THE INFORMATION NEEDED TO TRANSPORT THE INDIVIDUAL TO THE NEAR BY EMERGNECY ROOM FOR FURHTER EVALUATION.,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/22/2021,01/22/2021,0.0,PVT,UNKNOWN,UNKNOWN,UNKNOWN,,DID NOT REPORT ANY ALLERGIES AT THE TIME OF PRE-VACCINATION SCREENING,"['Anger', 'Blood glucose normal', 'Confusional state', 'Hypotension', 'Pulse absent', 'Unresponsive to stimuli']",1,MODERNA,IM 994376,FL,21.0,M,Elevate blood pressure and pulse Abnormal EKG Mild heart attack,Not Reported,,Yes,Yes,2.0,Not Reported,U,01/28/2021,01/29/2021,1.0,PVT,Zyretec 10 mg,No,Autism,,"Demerol, PCN, nuts, trees","['Blood pressure increased', 'Blood test', 'Catheterisation cardiac', 'Echocardiogram', 'Echocardiogram abnormal', 'Electrocardiogram', 'Myocardial infarction', 'Pulse abnormal', 'Troponin']",2,MODERNA,SYR 994388,IN,78.0,F,"shortness of breath, chest pain",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/26/2021,01/29/2021,3.0,PVT,,,"Prior stent 2015, new stent 2021 T2DM anemia HTN HLD",,,"['Chest pain', 'Dyspnoea']",UNK,MODERNA,IM 994450,MI,,F,"Pulmonary embolism; Chest pain; Shortness of breath; Arm swelling; Soreness in her arm; Local reaction in the lymph nodes of the axilla; A spontaneous report was received from a physician concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed pulmonary embolism, arm swelling and soreness, shortness of breath, chest pain and a reaction in the lymph nodes of the axilla The patient's medical history includes pulmonary embolisms. Relevant concomitant medications were not reported. On an unknown date, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The patient experienced a pulmonary embolism, arm swelling, arm soreness, a local reaction in the lymph nodes of the axilla, shortness of breath, and chest pain. CT scan showed small acute embolism. Action taken with mRNA-1273 in response to the events was not provided . The outcome of the events pulmonary embolism, arm swelling and soreness, shortness of breath, chest pain and a reaction in the lymph nodes of the axilla were not reported.; Reporter's Comments: Company Comment: This spontaneous report concerning a female patient who experienced unexpected serious event of pulmonary embolism and nonserious events of arm swelling and soreness, a reaction in the lymph nodes of the axilla, shortness of breath, and chest pain. The patient developed the events on an approximately 5 days after the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). Pulmonary embolism was confirmed via CT. There is not enough information to adequately evaluate and assess the event of pulmonary embolism. Swelling and soreness, a reaction in the lymph nodes of the axilla are temporally associated with the vaccine administration and in the absence of any other etiology, a causal association between these events and the administration of mRNA-1273 vaccine cannot be excluded. main field defaults to �possibly related' for all events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Pulmonary embolism,,,"['Chest pain', 'Computerised tomogram abnormal', 'Condition aggravated', 'Dyspnoea', 'Lymphadenopathy', 'Pain in extremity', 'Peripheral swelling', 'Pulmonary embolism']",1,MODERNA,OT 994451,TX,78.0,F,"Pneumonia in left lung; Pain in neck; Acute serious pain under her ribs, all the way around her body; A spontaneous report was received from a consumer concerning a 78 year old female who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed acute serious pain under her ribs, all the way around her upper body, pneumonia in her left lung and neck pain. The patient's medical history was not provided. Concomitant medications included non specified medication for blood pressure, calming down, dementia and thyroid. On 04 Jan 2021, approximately 2.5 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 04 Jan 2021, the patient developed acute serious pain under her ribs, all the way around her upper body that lasted ten days. The patient also experienced neck pain. On an unknown date, she was treated in the emergency room for pneumonia in her left lung and given antibiotics. She later followed up with her primary care doctor and additional x-rays were taken and she was treated with prednisone. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, acute pain under her ribs, all the way around her upper body, was considered resolved on 14 Jan 2021. The outcome of the event, pain neck was resolved on 19 Jan 2021. The outcome of the event, pneumonia in left lung, was unknown.; Reporter's Comments: Company Comment: This case concerns a 78-year-old female patient who experienced unexpected serious event of pneumonia and non-serious event of acute serious pain under her ribs, all the way around her upper body and neck pain. The event developed on the same day after the first dose and only dose of the vaccine mRNA-1273 vaccine (lot # unknown, expiration date-unknown). Although a temporal association exist between the event of pneumonia and the administration of the vaccine, in the absence of clinical details including diagnostic test, a definite diagnosis was not established. The events of acute serious pain under her ribs, all the way around her upper body and neck pain are also temporarily associated with vaccine administration and a causal association cannot be excluded. Main field defaults to �possibly related' for all events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Abdominal pain upper', 'Musculoskeletal chest pain', 'Neck pain', 'Pain', 'Pneumonia']",1,MODERNA,OT 994452,VA,,F,"she fell down and blacked out; dehydration; Dizzy; weak; woke up 3 different times to use the bathroom; Broke out in terrible sweat twice; was bruised up; Fever; Really sore arm; flu like symptoms; A spontaneous report was received from a consumer concerning an 82-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu-like symptoms, a really sore arm, fever, woke up 3 different times to use the bathroom, felt like she would pass out, felt dizzy, weak, blacked out, bruised up, broke out in a terrible sweat twice, and dehydration. The patient's medical history was not provided. No relevant concomitant medications were reported. On 13 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection. On 14 Jan 2021, the patient experienced flu-like symptoms and a really sore arm. The following two days she ""was okay"". On 17 Jan 2021, the patient had a fever of 99 degrees F; it was reported that she was already taking acetaminophen. She woke up three times in the middle of the night to use the bathroom, which was unusual for her. The third time she woke up, she could not get off the toilet; she felt dizzy and weak, and thought she was going to pass out. While she was trying to return to the bedroom, she blacked out and fell down. She was bruised up and ""broke out in terrible sweat twice"". It was reported that she drank water and orange juice to help with dehydration. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events flu-like symptoms, a really sore arm, fever, woke up 3 different times to use the bathroom, felt like she would pass out, felt dizzy, weak, blacked out, bruised up, broke out in a terrible sweat twice, and dehydration were not reported.; Reporter's Comments: Company Comment: This spontaneous report concerns a 82-Year-old, female patient who experienced unexpected serious event of blacked out and non-serious events of flu-like symptoms, a really sore arm, fever, woke up 3 different times to use the bathroom, felt like she would pass out, felt dizzy, weak, bruised up, broke out in a terrible sweat twice and dehydration. The patient developed flu-like symptoms and a really sore arm 1 day after the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). The other events developed 4 days after vaccine initiation. No treatment was provided, and the outcome of the events was not reported. There is limited information to assess all events in the absence of the patient's medical history and advanced age. Based on the information provided which includes a temporal association and in the absence of any other etiology, a causal association between the other reported events and the administration of mRNA-1273 vaccine cannot be excluded. The event of fever is consistent with the safety profile of mRNA-1273 vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/14/2021,1.0,UNK,NEURONTIN; NORVASC,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Asthenia', 'Body temperature increased', 'Contusion', 'Dehydration', 'Dizziness', 'Hyperhidrosis', 'Influenza like illness', 'Loss of consciousness', 'Pain in extremity', 'Pyrexia']",1,MODERNA,OT 994454,NE,19.0,F,"Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional. A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies. On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,PVT,HUMALOG; SPIRONOLACTONE; FLUVOXAMINE; XANAX XR,,Medical History/Concurrent Conditions: Celiac disease; COVID-19; Heartburn; Type 1 diabetes mellitus,,,"['Anaphylactic reaction', 'Aphasia', 'Apparent life threatening event', 'Arthralgia', 'Chest discomfort', 'Chest pain', 'Decreased appetite', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Headache', 'Hypotension', 'Injection site pain', 'Injection site swelling', 'Loss of consciousness', 'Lymph node pain', 'Lymphadenopathy', 'Mobility decreased', 'Nausea', 'Pain', 'Pharyngeal swelling', 'Pyrexia', 'Speech disorder']",1,PFIZER\BIONTECH, 994455,NJ,,M,"cardiac arrest; This is a spontaneous report from a contactable consumer. An elderly ( older that 65-years-old) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), via an unspecified route of administration on 20Jan2021 as the second single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. He was reported as with unspecified health issues, and no known allergies. The patient previously received BNT162B2 for immunization, on an unspecified date. The patient experienced cardiac arrest on 23Jan2021, at 20:30, which was serious as it was life-threatening and involved hospitalization (in the intensive care unit (ICU)). Details were as follows: after the patient received the 2nd dose of the vaccine on 20Jan2021. The reporter indicated that he was released to go on 23Jan2021. The patient went into cardiac arrest. Therapeutic measures were taken as a result of cardiac arrest. The patient was reported as in the ICU, and critical on life support. There was no note of COVID prior to vaccination. It was unknown if the patient has had a COVID tested post vaccination. The outcome of cardiac arrest was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.",Not Reported,,Yes,Yes,,Not Reported,N,01/20/2021,01/23/2021,3.0,SEN,,,,,,"['Cardiac arrest', 'Intensive care', 'Life support']",2,PFIZER\BIONTECH, 994502,FL,78.0,M,Change in gait followed by seizure like bilateral movements. Transported to hospital and admitted. 2 days of testing and consults. Symptoms gradually decreased and released 2 days later.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/19/2021,01/20/2021,1.0,OTH,"levothyroxin, pravastatin, warfarin, carvedilol, valsartan, lumigan, glimepiride, renexa, hydrochlorothiazide",none,"hypertension, afib, atherosclerosis",,none,"['Blood test normal', 'Cardiac function test normal', 'Chest X-ray normal', 'Computerised tomogram normal', 'Dyskinesia', 'Gait disturbance', 'Neurological examination normal', 'Seizure like phenomena', 'Ultrasound scan normal', 'Urine analysis normal']",UNK,MODERNA,IM 994504,,77.0,F,Chest pain; Fever; Hypokalemia; Pyelonephritis,Not Reported,,Not Reported,Yes,,Not Reported,N,01/30/2021,01/31/2021,1.0,UNK,,,,,,"['Chest pain', 'Hypokalaemia', 'Pyelonephritis', 'Pyrexia']",2,PFIZER\BIONTECH, 994515,,82.0,M,Acute on chronic respiratory failure with hypoxemia; Acute urinary retention; Arterial leg ulcer; Cardiac rhythm disorder or disturbance or change; Chest discomfort; Chest pain; SOB (shortness of breath),Not Reported,,Not Reported,Yes,,Not Reported,N,01/30/2021,01/31/2021,1.0,UNK,,,,,,"['Acute respiratory failure', 'Arrhythmia', 'Chest discomfort', 'Chest pain', 'Dyspnoea', 'Hypoxia', 'Ischaemic skin ulcer', 'Skin ulcer', 'Urinary retention']",2,PFIZER\BIONTECH, 994532,,74.0,F,Altered mental status; Chest pain; Elevated troponin; Generalized weakness,Not Reported,,Not Reported,Yes,,Not Reported,U,01/30/2021,01/31/2021,1.0,UNK,,,,,,"['Asthenia', 'Chest pain', 'Mental status changes', 'Troponin increased']",2,PFIZER\BIONTECH, 994544,TX,84.0,F,"The patient went home around 11 am on 1-31-21 after her vaccine and 15 minute observation period. She was eating breakfast after at home and complained to a neighbor that her teeth hurt and she was nauseated after eating. In the afternoon, she felt dizzy and had diarrhea accompanied with blood. Close to 9 PM, her son went to check on her. The patient was found on the floor--she was unresponsive and had purple lips. Her son called an ambulance and started chest compressions. The patient passed away at the hospital. The doctor has ordered an autopsy, and the results are pending.",Yes,01/31/2021,Not Reported,Not Reported,,Not Reported,N,01/31/2021,01/31/2021,0.0,PHM,,,,,,"['Autopsy', 'Cyanosis', 'Death', 'Dental discomfort', 'Diarrhoea haemorrhagic', 'Dizziness', 'Nausea', 'Resuscitation', 'Toothache', 'Unresponsive to stimuli']",2,MODERNA,IM 994613,FL,74.0,M,"after shot i didn't have any problems and then i came home. On Monday I slipped getting out of bed and hit my head on the floor , i couldn't move or talk, Wife called 911 and went to ER. had a Stint put in my head. Went into ICU discharged. I was diagnosed with Stroke",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/14/2021,01/18/2021,4.0,PUB,"omeprazole 20 mg , multivitamin, Flonase, atorvastatin 40 mg , Aspirin 81 mg, Zyrtec",defibulator battery changed on 12/30/2020,High Cholesterol,,,"['Aphasia', 'Blood test', 'Cerebrovascular accident', 'Echocardiogram', 'Fall', 'Head injury', 'Intensive care', 'Movement disorder', 'Suture insertion']",1,PFIZER\BIONTECH,SYR 994674,CA,53.0,F,"Bell's Palsy; This is a spontaneous report from a contactable other HCP (patient). A 53-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL 3247), via an unspecified route of administration at Left arm on 15Jan2021 11:00 AM at SINGLE DOSE for covid-19 vaccination. The patient was not pregnant. Concomitant medications in two weeks included lithium, levothyroxine sodium (LEVOTHROID), omeprazole. Historical Vaccine included first dose of bnt162b2 (lot number EL 1284) on 29Dec2020 11:00 AM at Left arm for covid-19 vaccination. The patient previously took ziprasidone hydrochloride (GEODON) and experienced drug allergies. It was reported no other medical history. On 17Jan2021 the patient woke up with left side of her face dropping. She went to the ER. She was diagnoses with Bell's Palsy. The event onset date was 17Jan2021 04:00 AM. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment drugs predizone and Acyclovir received for the event. The outcome of the event was not recovered. No covid prior vaccination, no covid tested post vaccination.; Sender's Comments: Based on the close temporal relationship, the association between the event Bell's palsy with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,,,WRK,LITHIUM; LEVOTHROID; OMEPRAZOLE,,,,,['Facial paralysis'],2,PFIZER\BIONTECH, 994675,IL,31.0,F,"numbness has moved up her neck; she touches her neck, it hurts a little; maintains numbness and ""no control of her arm""/can barely move her right arm; paralyzed at the shoulder from the elbow up;it's numb; can barely move her right arm; paralyzed at the shoulder from the elbow up; flu like symptoms; Threw up a couple times; mild pain at the injection site; This is a spontaneous report from a contactable nurse reporting for herself. A 31-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EL3247, Expiry date 31May2021, via an unspecified route of administration in right arm on 16Jan2021 at 07:30 at single dose for COVID-19 immunization as frontline worker. The patient had no relevant medical history. There were no concomitant medications. The patient received BNT162B2 Pfizer-BioNTech COVID-19 Vaccine in Hospital. The patient reported that she was fine all day Saturday (16Jan2021), she just had some very mild pain at the injection site started a couple hours after getting injection. She developed flu like symptoms on the following day (17Jan2021) at 18:00PM and threw up a couple times. On 18Jan2021 at noon she noticed that she could barely move her arm: anything above her elbow on her right arm was not moving; it was paralyzed at the shoulder from the elbow up. If someone were to pick it up and let go, she couldn't control it at all. She also stated that she had no pain at all in that arm; she couldn't feel anything at all; it was numb. When she woke up on 19Jan2021 the numbness had moved up her neck, instead of being localized to her arm. She stated that when she touched her neck, it hurt a little, but it was not super significant. She stated that it was debilitating at that point as she was maintaining numbness and ""no control of her arm"". The nurse reported that this event had not required yet a visit to physician, but she has a feeling it will. She will probably have to go somewhere due to her paralyzed arm, but she had not yet. At the time of the report the event ""No control of her arm""/can barely move her right arm; paralyzed at the shoulder from the elbow up; it's numb"" had not resolved yet; the event ""mild pain at the injection site"" resolved on 17Jan2021, the events ""Flu like symptoms"" and ""Threw up a couple times"" were recovering and outcome of the events ""Numbness has moved up her neck"" and ""She touches her neck, it hurts a little"" was unknown. The reporter assessed the events ""Pain injection site"" and ""Flu like symptoms"" as non-serious and assessed the event ""Can barely move her right arm; paralyzed at the shoulder from the elbow up; it's numb"" as disabling. She assessed all the reported events as related to BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (method of assessment: Global Introspection).; Sender's Comments: Based on the temporal relationship, the association between the events numbness of upper extremity and arm paralysis with BNT162b2 use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/16/2021,01/16/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Hypoaesthesia', 'Influenza like illness', 'Injection site pain', 'Mobility decreased', 'Neck pain', 'Paralysis', 'Vomiting']",1,PFIZER\BIONTECH, 994676,CA,83.0,F,"stroke-like symptom; Left arm droop; no feeling on left side; loss of mobility in left arm; droop on left side of face; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: Ek4176) via an unspecified route of administration on 16Jan2021 at 10:00 AM at a single dose for COVID-19 immunization. Medical history included blood pressure needs controlling and allergies: penicillin. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included nebivolol hydrochloride (BYSTOLIC), terazosin, famotidine, olmesartan (reported as olmsartan), amlodipine, and atorvastatin calcium (ATORVASTIN). Facility where the most recent COVID-19 vaccine was administered at nursing home/senior living facility. The patient was not pregnant at the time of vaccination. On Tuesday 19Jan2021 at 5 am, patient had stroke-like symptom: left arm droop, no feeling on left side, loss of mobility in left arm, droop on left side of face. The event resulted in emergency room/department or urgent care, and hospitalization. The event was reported as serious with seriousness criteria of caused/prolonged hospitalization. It was unknown if treatment received for event. The outcome of event was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/16/2021,01/19/2021,3.0,SEN,BYSTOLIC; TERAZOSIN; FAMOTIDINE; OLMESARTAN; AMLODIPINE; ATORVASTIN,,Medical History/Concurrent Conditions: Blood pressure abnormal (blood pressure needs controlling); Penicillin allergy,,,"['Facial paralysis', 'Hemiparesis', 'Hypoaesthesia', 'Mobility decreased', 'Neurological symptom']",1,PFIZER\BIONTECH, 994677,HI,47.0,F,"throat closing; tingling immediately in left arm; rapid heartbeat; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL 1283), intramuscular in the left arm on 08Jan2021 at 17:00 (at the age of 47-years-old) as a single dose for Covid-19 immunization. Medical history included migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food or other products. The patient's concomitant medications included minocycline (MANUFACTURER UNKNOWN) for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 08Jan2021 at 17:00, the patient experienced tingling immediately in left arm following injection, rapid heartbeat and throat closing. The patient was treated for the throat tightness, paraesthesia and heart rate increased which included diphenhydramine (BENADRYL), oral steroids, EKG and blood pressure monitoring. The events did initiate an emergency room visit. The clinical outcome of the events throat tightness, paraesthesia and heart rate increased was recovered with sequel. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported ""throat closing"" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,MINOCYCLINE,,Medical History/Concurrent Conditions: Migraine,,,"['Electrocardiogram', 'Heart rate increased', 'Immediate post-injection reaction', 'Injection site paraesthesia', 'Palpitations', 'Paraesthesia', 'Pharyngeal swelling', 'Throat tightness']",1,PFIZER\BIONTECH,OT 994678,KY,80.0,F,"patient contracted COVID; patient contracted COVID; This is a spontaneous report from a contactable consumer. A non-pregnant 80-year-old female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, the first dose in 2020 and the second dose on 22Dec2020 11:00, both at a single dose for covid-19 immunization. Medical history included heart, diabetes, obesity. There were no concomitant medications. The patient did not have covid prior to vaccination. The patient contracted COVID on 04Jan2021 11:00. The patient was hospitalized for COVID-19 for 8 days. The patient underwent lab tests and procedures which included: Nasal Swab: negative on 24Dec2020, negative on 28Dec2020, negative on 31Dec2020, positive on 04Jan2021. Unspecified therapeutic measures were taken as a result of the event. The outcome of patient contracted COVID was fatal. The patient died on 12Jan2021. It was unknown if an autopsy was performed. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Reported Cause(s) of Death: patient contracted COVID",Yes,01/12/2021,Not Reported,Yes,8.0,Not Reported,N,,01/04/2021,,SEN,,,Medical History/Concurrent Conditions: Diabetes; Heart disorder; Obesity,,,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 994679,LA,66.0,F,"pain under her arm; pinched nerve in my neck and blood pressure went up to 182/98; I have pinched nerve in my neck and blood pressure went up to 182/98; arm where she got the shot hurt like it was very tender; left breat hurt/then right breast hurt; having a little bit of trouble with asthma; congested and sneezing; congested and sneezing; bumpy rash on her chest and arms; puffiness/swelling in the neck; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration on 14Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing asthma and high blood pressure unknown if ongoing; both from unknown dates. Concomitant medications included prednisone (MANUFACTURER UNKNOWN) for asthma, unspecified vitamins and an inhaler for asthma. On 14Jan2021, the patient received the vaccination. She had a reaction to the vaccine almost immediately within 15 minutes of receiving vaccine. First, she had a pinched nerve in her neck and blood pressure went up to 182/98. Then about an hour later, the arm where she got the shot hurt like it was very tender. Then, her left breast hurt, followed by her right breast hurt. A few days later on 17Jan2021, she had breast pain and also pain under her arm. In Jan2021, she was also have some trouble with her asthma, was congested and sneezing. She had bumpy rash on her chest and arms. It was like tiny little bumps but it was not painful. She also had puffiness/swelling in the neck. The clinical outcomes of the pinched nerve in her neck, blood pressure went up to 182/98, arm where she got the shot was tender, breast pain, pain under arm, trouble with her asthma, congested and sneezing, bumpy rash, and puffiness/swelling in the neck were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/01/2021,,UNK,PREDNISONE,Asthma,Medical History/Concurrent Conditions: Blood pressure high,,,"['Asthma', 'Axillary pain', 'Blood pressure increased', 'Breast pain', 'Condition aggravated', 'Injection site pain', 'Nerve compression', 'Pain in extremity', 'Rash', 'Respiratory tract congestion', 'Sneezing', 'Swelling']",UNK,PFIZER\BIONTECH, 994698,,87.0,F,Embolic stroke involving left middle cerebral artery; Impaired mobility and ADLs; Stroke,Not Reported,,Not Reported,Yes,,Not Reported,U,01/30/2021,01/31/2021,1.0,UNK,,,,,,"['Cerebrovascular accident', 'Embolic stroke', 'Loss of personal independence in daily activities', 'Mobility decreased']",2,PFIZER\BIONTECH, 994710,,73.0,F,Acute kidney injury; CHF (congestive heart failure); COVID-19 virus infection; Chronic hepatitis C without hepatic coma; Edema leg; Essential hypertension,Not Reported,,Not Reported,Yes,,Not Reported,N,01/26/2021,01/31/2021,5.0,UNK,,,,,,"['Acute kidney injury', 'COVID-19', 'Cardiac failure congestive', 'Chronic hepatitis C', 'Essential hypertension', 'Oedema peripheral']",1,MODERNA, 994726,,71.0,M,"Angina at rest; Chest pain; Dyspnea, unspecified type; NSTEMI (non-ST elevated myocardial infarction); SOB (shortness of breath)",Not Reported,,Not Reported,Yes,,Not Reported,N,01/30/2021,01/31/2021,1.0,UNK,,,,,,"['Acute myocardial infarction', 'Angina unstable', 'Chest pain', 'Dyspnoea']",2,PFIZER\BIONTECH, 994731,,78.0,F,"[Pfizer covid -19 vaccine] treatment under Emergency Use Authorization(EUA): Patient in clinic for 2nd dose of covid vaccine. Within 8 minutes of receiving her injection, pt developed a rash on both arms; pt states both arms are itch and her throat felt as if it were closing. Rapid response called and patient was given Epinephrine per anaphylaxis protocol by LPN at 4:26pm. BP-146/98 p88 R17 Rapid response team arrived at 427pm. 429pm: Assessment: patient stable but felt no improvement in her throat. Pt was transported to ED for assessment.",Not Reported,,Not Reported,Yes,,Not Reported,,01/18/2021,01/29/2021,11.0,UNK,,,,,,"['Pruritus', 'Rash', 'Throat tightness']",UNK,PFIZER\BIONTECH,IM 994739,PA,50.0,F,Went to ER with left facial paralysis. Diagnosed with Bell's palsy day 19 after initial dose of Pfizer vaccine (1/5/21 vaccine given). Not sure what the recommendation is as to whether I should still have the second dose. Doctors at the ER were not sure either.,Not Reported,,Not Reported,Not Reported,,Yes,,01/05/2021,01/24/2021,19.0,UNK,Metoprolol tartrate; Vitamin d3 Vitamin c Magnesium Zinc,Na,None,,"Penicillin, sulfa","['Facial paralysis', 'Lyme disease']",UNK,PFIZER\BIONTECH,IM 994756,MI,,F,"My mom who is 75 had an adverse reaction on from the COVID vaccine she took on Jan 15, 2021. She went to bed at night and woke up at 4 AM with a severe headache. She took Aleve and went back to bed. When she woke up at 8:30 AM her headache was very severe and was accompanied with very severe chest pain. I immediately took her to the ER. They did a very thorough work up to check on her heart and Aorta. They managed her severe pain with two doses of morphine followed by two days of Dilaudid. The imaging and symptoms left her with a newly discovered diagnosis of Pericarditis. The medical professions were sure this was a result of the COVID vaccine. They continued to treat her for a few days and sent her home with anti inflammatories to help. She continues to have muscle pain, weakness and shortness of breath when she walks. She is scheduled to take her 2nd dose on February 5th but we are very concerned and hesitant as we don't want to cause any more damage to her heart. Please have somebody contact us and let us know how to proceed. Thanks.",Not Reported,,Yes,Yes,,Not Reported,,01/15/2021,01/16/2021,1.0,UNK,,,Jone,,None,"['Asthenia', 'Chest pain', 'Dyspnoea', 'Dyspnoea exertional', 'Headache', 'Imaging procedure abnormal', 'Myalgia', 'Pericarditis']",UNK,PFIZER\BIONTECH, 994770,TX,65.0,M,Two days after getting shot started getting ringing in both ears. Has gotten louder high pitched buzzing sound in both ears and still have it,Not Reported,,Not Reported,Not Reported,,Yes,N,01/08/2021,01/10/2021,2.0,PUB,Aspirin 1/4 of 325mg Clopidogrel 75mg Loratadine 10mg Atorvastatin 20mg Pantoprazole 40mg Tamsulosin HBL 0.4mg,None,None,,None,['Tinnitus'],1,MODERNA,IM 994778,SC,97.0,F,Resident received the vaccine on 1-22-21 and she was diagnosed with COVID-19 during routine testing on 1-28-21. She didn't have any symptoms except feeling weak and she had a decrease in her appetite. She already had a poor appetite prior. She died on 2-2-21.,Yes,02/02/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/28/2021,6.0,SEN,"Pepcid, Aspirin, DOK Plus, Miralax, Potassium Chloride ER, Vitamin C, Ensure Clear, Metoprolol Tartrate, Tramadol, Artificial Tears,",,"OTHER INTERVERTEBRAL DISC DEGENERATION, LUMBAR REGION, Macular Degeneration, Anorexia, Peripheral Vascular Disease, Cardiac Arrhythmia,",,No known allergies,"['Asthenia', 'COVID-19', 'Condition aggravated', 'Death', 'Decreased appetite', 'SARS-CoV-2 test positive']",1,MODERNA,IM 994788,KY,74.0,F,Patient death on 2/1/2021 at 4:55am at hospital.,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/01/2021,7.0,SEN,"Patient was a nursing home resident, please contact the facility for further scheduled medications.","Patient was a nursing home resident, please contact the facility for further diagnosis.","Patient was a nursing home resident, please contact the facility for further diagnosis.",,"Ativan, Buspar, Cymbalta, Levaquin, Lyrica, Mirapex, Pristiq, Symbicort",['Death'],1,PFIZER\BIONTECH,IM 994790,KY,58.0,F,Resident found unresponsive in room this am at approx. 9:30 am. Resident was observed eating breakfast around 8:45 am. Housekeeper reported seeing resident between breakfast and time found unresponsive. Resident had voiced no complaints. Code was initiated until EMS arrived and transported resident to hospital. Resident expired.,Yes,02/02/2021,Not Reported,Not Reported,,Not Reported,N,01/31/2021,02/02/2021,2.0,SEN,"Prevacid, Hydrocodone, Famotidine, Combivent Respimat, Boniva, Zinc Oxide, Spiriva, Loratadine, Risperdal, Albuterol, Sertraline, Cyanocobalamin, Levothyroxine, Advair, Omega-3 fatty acids, Atorvastatin, Aspirin, Sennoside, Ergocalciferol,",none,"COPD, cad, morbid obesity, depression, bipolar, hypothyroidism, hypertension and gerd.",,"Ibuprofen, ketorolac, morphine,tramadol.","['Cardio-respiratory arrest', 'Death', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 994791,MN,36.0,F,Tested positive for COVID 1/23/21. Was asymptomatic at the time and was tested due to positive household members. Developed symptoms (headache) 1/25/21. Developed sensation change (pins and needles) in left arm 1/31/21. Was seen in Emergency Room and kept overnight for observation. No obvious cause for symptoms was found.,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/05/2021,02/01/2021,27.0,PVT,,,,,,"['COVID-19', 'Exposure to SARS-CoV-2', 'Headache', 'Paraesthesia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 994801,TN,36.0,F,"Started with some nausea around noon on 1/18 that resolved, then experienced nausea without emesis and palpitations while driving to work at 1800. She describes it as feeling like her heart was racing, but also feeling like she was having large pauses in her heart rate in between the palpitation sensations. She drank a bottle of water and the feeling went away temporarily but it returned. I am an employee, on arriving to work I noted increased shortness of breath which is unusual for me because I am an avid runner and very active. I noted the palpitations from around 1800-2000, including becoming dizzy and lightheaded during my shift which could endanger patient care, so I presented to the ED and was placed in the CCA. I had received both covid vaccines, second one on 1/11/21 and had about 20H malaise/fatigue and some expiratory wheezing which was abnormal for her but all has since resolved. I had intermittent heart palpitations and chest until 1/26",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/11/2021,01/18/2021,7.0,PVT,"multi vitamin, PRN Ambien",no,occasional heart burn,,"Penicllin, ceclor","['Arrhythmia', 'Cardiac stress test', 'Computerised tomogram', 'Dizziness', 'Dyspnoea', 'Echocardiogram', 'Electrocardiogram', 'Electrocardiogram ambulatory', 'Fatigue', 'Fibrin D dimer', 'Full blood count', 'Malaise', 'Metabolic function test', 'Nausea', 'Palpitations', 'Thyroid function test', 'Troponin', 'Wheezing']",2,PFIZER\BIONTECH, 994898,TX,47.0,F,"Fatigue; Chest pain; Short of breath; Hot; Tingly; Flush; Heart racing; Oxygen level low; Tachycardia; Anxiety issues; A spontaneous report was received from a healthcare professional concerning a 47-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and felt warm and tingly, flushing, experienced rapid heart rate, shortness of breath, anxiety issues, difficulty breathing, fatigue, chest pain, tachycardia, and low oxygen saturation. The patient's medical history includes contact dermatitis. Concomitant product use were not provided/unknown by the reporter. On 28 Dec 2020, approximately five minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right shoulder for prophylaxis of COVID-19 infection. On 28 Dec 2020 the patient felt warm and tingly, flushing, experienced rapid heart rate, shortness of breath, panic, difficulty breathing, shortness of breath, tachycardia, and low oxygen saturation. On 29 Dec 2020 the patient experienced fatigue, chest pain, and shortness of breath. She was triaged to the emergency room where her EKG and vital signs were normal. The events were treated with oxygen and cetirizine. Action taken with mRNA-1273 in response to the events was not provided/unknown. The outcome of the events, warm and tingly, flushing, experienced rapid heart rate, panic, difficulty breathing, shortness of breath, tachycardia, and low oxygen saturation was considered resolved on Dec 28 2020. The outcome of the events, fatigue, chest pain, and shortness of breath, was considered unknown.; Reporter's Comments: This case concerns a 47-year-old female patient, with medical history of contact dermatitis with polyethylene glycol containing makeup and shampoo products, who experienced a serious unexpected event of dyspnea and non-serious unexpected events of feeling hot, paraesthesia, flushing, palpitations, oxygen saturation decreased, tachycardia, anxiety, and chest pain, and non-serious expected event of fatigue.The event of dyspnea, feeling hot, paraesthesia, flushing, palpitations, oxygen saturation decreased, tachycardia, and anxiety occurred 1 day (same day) after first dose of mRNA-1273, lot # unknown. The event of occurred 2 days after first dose of mRNA-1273, lot # unknown. Treatment included nasal oxygen and Zyrtec. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,,Contact dermatitis (Contact dermatitis with polyethylene glycol containing makeup and shampoo products),,,,"['Chest pain', 'Dyspnoea', 'Electrocardiogram normal', 'Fatigue', 'Feeling hot', 'Flushing', 'Heart rate increased', 'Oxygen saturation decreased', 'Palpitations', 'Panic disorder', 'Paraesthesia', 'Tachycardia']",1,MODERNA,OT 994899,,52.0,F,"passed out; hit chin on the sink; vomited; Fever; chills; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 at single dose on unspecified date for covid-19 immunization. Patient had one of the worst nights, fever/chills on 18Jan2021. Got up at 1:30 on 19Jan2021 to use the bathroom, passed out and hit chin on the sink. Then vomited. Still low fever. Patient didn't receive treatment for events. Outcome of all events was recovering. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report was considered as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/18/2021,0.0,UNK,,,,,,"['Chills', 'Face injury', 'Injury', 'Insomnia', 'Loss of consciousness', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH, 994900,TN,38.0,M,"Extreme pain in my right thumb/ very sharp pain in the middle and base of my thumb; This is a spontaneous report from a contactable pharmacist reported for himself. A 38-year-old male patient received second dose of bnt162b2 (Lot number: EJ1686), via an unspecified route of administration in left arm on 07Jan2021 09:00 at single dose for covid-19 immunization. Medical history included HTN (hypertension) from an unknown date and unknown if ongoing. Concomitant medication included amlodipine, hctz, amfetamine sulfate (AMPHETAMINE-SALTS). The patient previous received first dose of bnt162b2 (Lot number: EJ1685), via an unspecified route of administration in left arm on 17Dec2020 11:00 AM for covid-19 immunization. The patient experienced extreme pain in his right thumb/ very sharp pain in the middle and base of my thumb on 09Jan2021 05:00. The event was reported as serious per disability. No treatment received for the adverse event. The adverse event result in disability or permanent damage. 36-48 hours after the second dose, the patient started experiencing extreme pain in my right thumb whenever he attempted to use his right hand for something including the simplest of tasks like tying his shoe. When he holds, lift, pull using his right hand he experienced a very sharp pain in the middle and base of his thumb. At first, he thought maybe he hit it on something, but he did not. A week later his wife was at work (she was a hair stylist) and was talking with one of her clients. Her client who is a nurse said recently she had also taken the vaccine (2nd shot) and said the weirdest thing had happened. She told her that she can't hold anything in her right hand, and she has been experiencing unbearable pain in her right thumb when she used it for anything. The pain has lasted almost two weeks now and was not going away. He still speak with the lady who has pain too and she said the same thing and he know it came after the second shot of the vaccine. The outcome of event was not resolved. Facility where the most recent COVID-19 vaccine was administered: Hospital. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Not known allergies.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported ""pain in thumb"" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021058634 same reporter/product/event, different patient",Not Reported,,Not Reported,Not Reported,,Yes,N,01/07/2021,01/09/2021,2.0,PVT,AMLODIPINE; HCTZ; AMPHETAMINE SALTS,,Medical History/Concurrent Conditions: Hypertension,,,"['Pain', 'Pain in extremity']",2,PFIZER\BIONTECH, 994901,,,F,some minor TIAs; had excessive bleeding from administration site; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number unknown) via an unspecified route of administration on 14Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had excessive bleeding from administration site and using four baby wipes until saturated and bled for approximately one hour. She received her vaccine last Thursday and is due for the next dose 05Feb2021. She is currently on clopidogrel and metoprolol for some minor TIAs. Is this a common issue with the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/01/2021,,UNK,,,,,,['Injection site haemorrhage'],1,PFIZER\BIONTECH, 994902,CA,,U,"Loss of vision; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration from an unspecified date single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced loss of vision in her right eye on an unspecified date. The outcome was unknown Information on the Lot/Batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Blindness unilateral'],UNK,PFIZER\BIONTECH, 994903,KS,26.0,F,"Blisters around hips, thighs, and elbows.; Intermittent chest pain and tightness; Intermittent chest pain and tightness; shortness of breath; Swollen lymph nodes under bilateral arms that have not decreased; Chills; sweating; Headache; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= ELO140), via an unspecified route of administration at left arm on 14Jan2021 12:00 at single dose for covid-19 immunization. Medical history included known allergies: cephalosporins, coconut. Other medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 05:00 AM, the patient experienced blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine and continuing into day 4 DOST vaccine, swollen lymph nodes under bilateral arms that had not decreased, chills and sweating, headache. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures post vaccination which included COVID nasal swab test and COVID PCR test, both were negative on 14Jan2021. The outcome of events was not recovered.; Sender's Comments: The reported blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/15/2021,1.0,SEN,,,Medical History/Concurrent Conditions: Allergy to antibiotic; Fruit allergy,,,"['Blister', 'Chest discomfort', 'Chest pain', 'Chills', 'Dyspnoea', 'Headache', 'Hyperhidrosis', 'Lymphadenopathy', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 994904,AZ,79.0,F,"Difficulty in walking / could not walk; her feet feel like they are numb; Dementia; This is a spontaneous report from a contactable consumer (patient). This 79 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284) in left arm, on 18Jan2021 at 12:00 PM or 01:00 PM, for COVID-19 immunisation. Medical history included pacemaker (she just had it checked on 18Jan2021 at the cardiologist and they said it was good for five more years), heart issue, dementia (before getting the vaccine). Concomitant medications were none. On an unspecified date in Jan2021 the patient experienced dementia (she had a bit of dementia right now, which she also had before getting the vaccine) and her feet felt like they were numb, like neuropathy (maybe she had that, it had never been checked). Since 19Jan2021 the patient could not walk, had difficulty in walking. She was using a cane as she did not want to fall, she weighed 200 lbs and her partner would never be able to get her up if she fell. She was able to walk with the cane. The patient said that there had been no other treatment for her difficulty in walking and it seemed to get better. The initial caller (patient's partner) said she had the shot too on 18Jan2021 and did not have those symptoms, she was not the one who was sick, she did not know what else was going on in her partner's body, they did not think the shot caused it. The patient said she was supposed to be on a sleep apnea machine but she could not get in to the doctor to get the machine checked, it needed a test to be rechecked but they could not get in to do it because of everything that is going on. The patient was scheduled to get the second dose on 08Feb2021 at 10:00AM. Difficulty in walking was improving. The other events outcome was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/01/2021,,UNK,,"Artificial cardiac pacemaker user (checked on 18Jan2021, it was good for five more years)",Medical History/Concurrent Conditions: Dementia (before getting the vaccine); Heart disorder,,,"['Cardiac disorder', 'Condition aggravated', 'Dementia', 'Gait disturbance', 'Gait inability', 'Hypoaesthesia', 'Malaise', 'Neuropathy peripheral', 'Walking aid user']",1,PFIZER\BIONTECH, 994905,MI,65.0,M,"my blood sugar has been up; I was 197 before breakfast; my blood sugar has been up; I was 197 before breakfast; This is a spontaneous report from a contactable consumer reporting for self. A 65-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing insulin dependent diabetic, hypertension, and kidney disorder. Concomitant medications included insulin aspart (NOVOLOG), insulin glargine (LANTUS), acetylsalicylic acid (ASPIRIN), lisinopril to make his kidneys strong. The patient stated he had the first shot and he believe one of the side effects was it can cause your blood sugar to go up. So, he had to monitor his blood sugar more closely. He got the vaccine on Thursday (14Jan2021), since then his blood sugar had been up. He stated that he was taking his insulin aspart and insulin glargine. Like today (18Jan2021) he took 4 units of because he was 197 before breakfast. The outcome of event was unknown. Information on Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/14/2021,0.0,UNK,NOVOLOG; LANTUS; ASPIRIN [ACETYLSALICYLIC ACID]; LISINOPRIL,Insulin dependent diabetic,Medical History/Concurrent Conditions: Hypertension; Kidney disorder,,,['Blood glucose increased'],1,PFIZER\BIONTECH, 994906,,,U,"I do not see well at all; Lost my sense of taste and smell; Those were the symptoms of the virus; Lost my sense of taste and smell; Those were the symptoms of the virus; Worried; This is a spontaneous report from a contactable consumer. A patient of unspecified gender and age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced lost sense of taste and smell. Patient worried that those were the symptoms of the virus; do not see well at all. Patient also stated that not see well at all in Jan2021. Outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/01/2021,,UNK,,,,,,"['Ageusia', 'Anosmia', 'Visual impairment']",UNK,PFIZER\BIONTECH, 994907,CA,65.0,M,"CHF exacerbation with new a fib/flutter, and AKI, elevated troponin,aspiration pneumonia, lactic acidosis",Not Reported,,Yes,Yes,5.0,Not Reported,N,01/25/2021,01/26/2021,1.0,PVT,"lasix, florinef, atorvastatin, glipizide, amlodipine, hydralazine, losartan, metoprolol XL, aspirin, Vitamin D","HFrEF, DM, CKD, HTN, anemia, dysphagia","HFrEF, DM, CKD, HTN, anemia, dysphagia",,clonidine,"['Acute kidney injury', 'Atrial fibrillation', 'Atrial flutter', 'Blood lactic acid', 'Cardiac failure chronic', 'Cardiac failure congestive', 'Condition aggravated', 'Echocardiogram', 'Lactic acidosis', 'Pneumonia aspiration', 'Troponin increased']",UNK,MODERNA,IM 994913,TN,48.0,F,"patient passed away 2 days after vaccine. patient had temperature, nausea, and vomiting after vaccine.",Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/31/2021,1.0,SEN,,,,,,"['Body temperature increased', 'Death', 'Nausea', 'Vomiting']",UNK,MODERNA, 994961,ND,81.0,M,"T 99.8, R 44, O2 94%, Pulse 132, Bp 199/82. Patient lethargic, confused, weak. Sent to local ED, and ED reported resident had MI and was transferred to another hospital for further workup. Patient tested positive for Listeria in urine at local ED as well, which may have contributed to this reaction.",Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/27/2021,01/28/2021,1.0,SEN,"Acetaminophen, Allegra, Aspirin, Atorvastatin, Budesonide Inhalation solution, Cyancobalamin 500mcg, Docusate capsule, Ferrex, Flonase, Furosemide, Gabapentin, Humulin, Ipratroprium-Albuterol Solution, Levothyroxine, Lorazepam, Metoprolol,",Tested positive for Listeria in urine on 1/21/21,"COPD, Rheumatoid arthritis, Major depressive disorder, athlerosclerotic heart disease, emphysema, hypertension, GERD, DMII, diarrhea, COVID-19 prior infection",,"Ceftriaxone, Levofloxacin","['Asthenia', 'Confusional state', 'Lethargy', 'Myocardial infarction', 'Urine analysis']",2,MODERNA,IM 994989,KY,56.0,F,Employee was found unresponsive in floor at her home. EMS arrived and person had expired.,Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/19/2021,9.0,SEN,unsure,unsure,unsure,,unsure,"['Death', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 995017,MN,45.0,M,"On 1/28/2021 at 0545 hours as I was on my way into work when I started to have severe right side chest pain, so much so that I had to pull over. Shortly thereafter ambulance arrived on scene at which time it was determined that I would be transported to the hospital. Once there, a series of tests were conducted, one of which was a D-Dimer blood test to rule out blood clots. That resulted in an elevated count to which a CT scan was ordered. The result of the CT scan revealed that I had 2 Pulmonary Embolisms, one in the upper lobe of my right lung and one in the middle lobe of my right lung. Due to me being what the doctors said was a healthy 45 year old with no underlying conditions or signs of DVT (deep vein thrombosis) they deemed me low risk at that time and advised I was at low risk of dying in the next 30days. However, they advised that at any time, the clot could possibly become dislodged and cause worse problems, possibly death if time is not given to the body to dissolve the clots. Ultimately it was determined that I be discharged and prescribed blood thinning medications to help thin the blood to prevent further clotting should I have a clotting issue (undetermined at this time).",Not Reported,,Yes,Not Reported,,Not Reported,N,01/12/2021,01/28/2021,16.0,OTH,None,None,None,,None,"['Chest pain', 'Computerised tomogram abnormal', 'Fibrin D dimer increased', 'Pulmonary embolism', 'Thrombosis']",1,MODERNA,IM 995023,FL,64.0,F,"Jan. 28, I'm fine, just some bearable site pain. Took tylenol before getting vaccine, and the next day around 4 in the morning started having malaise, pain, fever, chills. (fever around 102), and went 104 around midafternoon, and 106 around 10. Chills, pain, weakness. Next day I was feeling well. I started noticing small dots on knee and shoulder. And then I started noticing bruising on my hands and legs. Felt fine on Sunday. I started noticing the bruises were becoming more pronounced. On Monday when I woke up the bruises were worse, and I went to the ER. The doctor checked CBC and platelets count was low around 28 thousand and was admitted into the hospital and they treated me with solumedrol 100 mg. Platelets count went back up.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/28/2021,01/29/2021,1.0,PVT,plaquenil 200 mg daily molbic 15 mg daily levophyroxine 75 mcg daily zyrtec 10 mg daily mulitvitmin 1 tablet omprazole 20 mg daily fish oil IU one tablet daily lutein 10mg once daily,none,hypo thyroid visem hyper thyroid visem rheumatoid arthritis,Moderna 12/31/2020 pain in arm,sulfa drugs,"['Asthenia', 'Chills', 'Contusion', 'Full blood count abnormal', 'Injection site pain', 'Malaise', 'Pain', 'Platelet count decreased', 'Pyrexia', 'Rash']",2,MODERNA,SYR 995140,CA,87.0,F,"Delusional and confrontational; Unable to take meds or eat; Seemed to be having a mental breakdown; Constantly obsessing over minutia that was not pertinent to what she is being asked to do; She gets very upset and anxious and angry; This is a spontaneous report from a contactable nurse. An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), intramuscular (left arm) on 15Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included depression, cerebrovascular accident (CVA), chronic heart failure (CHF), emphysema, and angina, all from unknown dates and unknown if ongoing. Concomitant medication included furosemide (LASIX), amlodipine, losartan, sertraline, nortriptyline, methazolamide, quetiapine fumarate (SEROQUEL), dorzolamide, tiotropium bromide (SPIRIVA), ciclesonide (ALVESCO), albuterol (ALBUTEROL [SALBUTAMOL]), carvedilol, calcium magnesium, iron, curcuma longa (TURMERIC), clarithromycin (CLARITIN), magnesium citrate, cyanocobalamin (B 12), paracetamol (TYLENOL), estradiol (ESTRACE) , d-mannose, vitamin D3. Concomitant medication also includes multivitamin, and stool softeners. It was reported that on 15Jan2021 at 15:30 the patient became delusional and confrontational and unable to take meds or eat. The patient seemed to be having a mental breakdown. No physician (MD) in ER would address the issue. It happened approximately two hours after the vaccine. She will not eat or take meds; she is constantly obsessing over minutia that was not pertinent to what she is being asked to do. For example, she comes up with steps she needs to take before she can eat, but she doesn't know them, so she gets very upset and anxious and angry. The events were assessed as life-threatening. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association. However high age of the patient and underlying medical conditions cannot be ruled out a contributory factors The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.",Not Reported,,Yes,Not Reported,,Not Reported,U,01/15/2021,01/15/2021,0.0,PVT,LASIX [FUROSEMIDE]; AMLODIPINE; LOSARTAN; SERTRALINE; NORTRIPTYLINE; METHAZOLAMIDE; SEROQUEL; DORZOLAMIDE; SPIRIVA; ALVESCO; ALBUTEROL [SALBUTAMOL]; CARVEDILOL; CALCIUM MAGNESIUM [CALCIUM;MAGNESIUM]; IRON; TURMERIC [CURCUMA LONGA]; CLARITIN,,Medical History/Concurrent Conditions: Angina pectoris; Chronic heart failure; CVA; Depression; Emphysema,,,"['Aggression', 'Apparent life threatening event', 'Delusion', 'Diet refusal', 'Mental disorder', 'Refusal of treatment by patient']",1,PFIZER\BIONTECH,OT 995141,IL,54.0,F,"kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Headache; Chills; Left arm hurting really bad; A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Jan2021 07:15 at single dose in left arm for covid-19 immunisation. Medical history included menopause from May2020 and ongoing (She is going through menopause, which started 7 months ago). There were no concomitant medications. Received call from consumer regarding the Pfizer BioNtech COVID vaccine. She had first vaccine yesterday morning and is experiencing some side effects. It looks like it was prescribed by a pharmacist, but she is not able to see the name and does not have any contact details to provide. She signed up at the online thing for reporting. Her arm is much better this morning. She woke up at 03:00 with the headache and still has it. Dizziness and weakness started 06:30 this morning. She kind of fainted. She was walking from one room to the next and she just gave out. It has improved and she is not really dizzy any more. She is having a little fatigue though. Chills began at 06:30 and they come and go. She is going through menopause and it could have something to do with it. She was unable to answer outcome for this. She just wants the headache to stop. She has not been able to do anything today. She is going through menopause, which started 7 months ago. She would like to know if there is something she can take for the headache. AE Details and time of onset: Left arm hurting really bad 18:00. When she first got it, she did not feel it. As the day progressed, she could feel the pain. Headache 03:00. Dizziness and weakness 06:30. Fatigue 06:30. Chills 07:00-07:30. She layed down at that point. Body feels tender and skin feels tender to touch 09:00. NO ER or physician's office required. No prior Vaccinations (within 4 weeks). The outcome of the event dizziness was resolved, Chills was unknown, Headache was not resolved, while the outcome of the other events was resolving. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/18/2021,0.0,PVT,,"Menopause (She is going through menopause, which started 7 months ago.)",,,,"['Asthenia', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Pain in extremity', 'Pain of skin', 'Syncope']",UNK,PFIZER\BIONTECH,OT 995142,NY,66.0,F,"Short fainting spell; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EJ1686), intramuscularly on 14Jan2021 after 15:00 (her appointment was at 1510 but she had to wait past her appointment time before she received it) in upper right arm at single dose for Prevent Covid in hospital. No history of all previous immunization with bnt162b2 considered as suspect. No additional vaccines administered on same date of bnt162b2. Medical history included breast cancer from 9 years before 19Jan2021 (2012) and she has been Anastrozole since, she was only supposed to take Anastrozole for 5 years and when she was one month away from being done with it she had a Seizure and she was found to have a Tumor in her brain, she had had Srs surgery on her brain on 13Apr2016, she was prescribed Levetiracetam, a seizure medication, for two years and had not had any problem since. Concomitant medication included ongoing anastrozole taking for about 9 years for Post breast cancer. No prior vaccinations within 4 weeks. The patient previously took levetiracetam for seizure, she stopped taking Levetiracetam 750mg about 2 or 3 years before 19Jan2021, flu shot on 05Dec2020 for immunization at the age of 66-year-old. The patient reported that she had a short fainting spell around 8:30am on 19Jan2021 and she was not sure if it was related to the Covid vaccine. She described that she had been sitting for a while and when she got up she felt like this black curtain coming down which she has felt before in the past but she usually recovered and never lost control to where she fainted. Her husband was there to catch her. She clarified that she never passed out. She did not have any reactions in the past few days since she received the covid vaccine, she did not even have soreness at injection site. The event was not required a visit to Emergency Room nor Physician Office. Relevant Tests was none. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/19/2021,5.0,PVT,ANASTROZOLE,,Medical History/Concurrent Conditions: Brain operation (Srs surgery on her brain on 13Apr2016); Brain tumor; Breast cancer (9 years before 19Jan2021); Seizure (felt like this black curtain coming down which she has felt before in the past),,,"['Feeling abnormal', 'Syncope']",UNK,PFIZER\BIONTECH,OT 995146,,72.0,M,"Narrative: Patient experienced cardiac arrest with PEA and a witnessed collapse upon arrival to the emergency department on 1/24/21. Patient received his first dose of the COVID vaccine on 01/15/2021and felt poorly thereafter. He was describing shortness of breath to his wife and requiring 5L of O2 at home to maintain saturations in 80s, while he usually was on 3L to maintain saturations in the mid 90s. He had been oriented but more fatigued than normal and described bilateral shoulder pain (which was not new for him) as well as indigestion. Took Tylenol with some relief. He had decreased PO intake and less appetite. The patient's wife encouraged him to come to the hospital daily for a week prior to admission, but the patient did not want to because he felt his side effects were secondary to the vaccine. Symptoms:RespDepression, Palpitations, Syncope & cardiac arrest Treatment: EPINEPHRINE 1 MG ONCE 3 rounds given ,CALCIUM CHLORIDE 1000 MG ONCE",Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,,01/15/2021,01/24/2021,9.0,OTH,,,,,,"['Arthralgia', 'Cardiac arrest', 'Decreased appetite', 'Dyspepsia', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Hypophagia', 'Palpitations', 'Pulseless electrical activity', 'Respiratory depression', 'Syncope']",2,MODERNA, 995222,MA,,F,"Lost consciousness; Lightheaded/Dizzy; Lost balance; Broke into a sweat; Site injection soreness; A spontaneous report was received from a 37 year old, female, consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced site injection soreness, lightheaded, dizzy, broke into a sweat, lost balance and lost consciousness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 19 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: B28L20A) intramuscularly for prophylaxis of COVID-19 infection. On 19 Jan 2021, after receiving the vaccine, the patient had site injection soreness at night. On the morning of 20 Jan 2021, the patient woke up feeling lightheaded and dizzy. She tried to walk and broke into a sweat, lost her balance and lost consciousness. A few moments later, everything came back. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The events, site injection soreness, lightheaded, dizzy, broke into a sweat, lost balance and lost consciousness were resolved on 20 Jan 2021.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Based on possible temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Balance disorder', 'Dizziness', 'Hyperhidrosis', 'Injection site pain', 'Loss of consciousness']",1,MODERNA,OT 995223,,,M,"Passed out; Low heart rate; Possible pneumonia; A spontaneous report was received from a consumer concerning an 84-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passed out, low heart rate, and possible pneumonia. The patient's medical history was not reported. There were no concomitant medications provided. On 15 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly, for prophylaxis of COVID-19 infection. On 17 Jan 2021, the patient was hospitalized for passed out, low heart rate, and possible pneumonia. The reporter's mom found the patient passed out on the floor. It was thought he may have passed out about 4 or 5pm. The patient was taken to the emergency room (ER) via ambulance. At that time his heart rate was 20 bpm. Physicians said he may have pneumonia. It was noted the patient still works and walks miles every day. The patient was still hospitalized at the time of this report. There was no treatment information provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome for the events of passed out, low heart rate, and possible pneumonia was unknown at the time of this report.; Reporter's Comments: This case concerns a 84 year old male patient who experienced a serious unexpected events of passed out, low heart rate, and possible pneumonia.The event occurred 2 days 7 hours after first dose of the vaccine. Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the start date of the event/s, a causal relationship cannot be excluded.",Not Reported,,Yes,Yes,,Not Reported,U,01/15/2021,01/17/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No adverse event was reported),,,"['Heart rate decreased', 'Loss of consciousness']",1,MODERNA,OT 995224,TX,92.0,F,"Cardiac arrest; Pain on her upper right chest; Lot of pain in lower abdomen; Pain underneath arm; Thought it was muscle aches; A spontaneous report was received from a nurse concerning a 92-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed upper right chest pain and underneath the arm, severe abdominal pain, muscle aches and cardiac arrest. The patient's medical history was not provided Concomitant product use was not provided by the reporter. On 14 Jan 2021, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection. On 19 Jan 2021, the patient developed upper right chest pain and pain underneath the arm. They thought it was muscle aches. Sometime later, the patient developed a lot of pain in the lower abdomen. The called emergency services and an ambulance arrived but the patient then suffered cardiac arrest. Treatment for the event included tramadol. Action taken with mRNA-1273 in response to the events was not applicable due to the patient was died. The patient died on 19 Jan 2021. The cause of death was reported as cardiac arrest. Autopsy were not provided.; Reporter's Comments: Company Comment: This case concerns a 92-year-old female patient who experienced unexpected serious events of cardiac arrest, upper right chest pain and underneath the arm, severe abdominal pain, muscle aches. The event occurred 5 days after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). Although a temporal association exist between the events and the administration of the vaccine, in the absence of critical details such as the patient's medical history, any diagnostic test or autopsy result, adequate evaluation and assessment cannot be established. Main field defaults to �possibly related' for all events.; Reported Cause(s) of Death: Cardiac arrest",Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/19/2021,5.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Abdominal pain lower', 'Axillary pain', 'Cardiac arrest', 'Chest pain', 'Death', 'Myalgia']",1,MODERNA,OT 995225,NJ,,F,"Felt like something dripping out of her; Felt like something dripping out of her; A spontaneous report was received from a consumer who was also a female patient, who received Moderna's COVID-19 Vaccine and experienced felt like something dripping out of her. The patient's medical history was not provided. Concomitant product use was not provided. On 18 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (batch number not reported) intramuscularly for COVID-19 infection prophylaxis. The patient reported that when the nurse took the needle out, she then gently squeezed the site where the patient got the shot and the patient felt something dripping out of her. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The event, felt like something dripping out of her, was considered resolved on 18 Jan 2021.; Reporter's Comments: This case concerns a female patient who received the first of two planned doses of mRNA-1273 (batch number not reported) intramuscularly for COVID-19 infection prophylaxis and experienced felt like something dripping out of her. There were no reported adverse events after the vaccine was administered in this case of injection site extravasation and incomplete dose administered",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/18/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Incorrect dose administered', 'Injection site extravasation']",1,MODERNA,OT 995231,NY,52.0,F,"she had positive COVID test; she had positive COVID test; This is a spontaneous report from a contactable nurse. A 52-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly in the left arm on 28Dec2020 16:00 at a single dose for covid-19 immunisation. The patient's medical history included tested positive for covid on 06Nov2020. The patient had recent physical in Dec2020, patient did blood work. Twelve years ago (2009) she had a partial thyroidectomy and at the physical they noticed a lump. The goiter was enlarged on her neck. She doesn't know if it a result from COVID, but she has Hashimoto's disease in Dec2020. She has to have surgery to removed the goiter, but she can't because of COVID. She has looked it up and it is an autoimmune disease. She had a fine needle biopsy and it was negative and she had a full thyroid work up that was fine in the beginning of Jan2021.The patient's concomitant medications were not reported. On 14Jan2021, the patient's test came back positive for covid. It was further reported that the patient tested negative on the Friday after holiday. She has been getting tested twice weekly since that time and they had all been negative. Patient was scheduled to get her second dose of the vaccine today (18Jan2021). The outcome of the event was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/14/2021,17.0,SEN,,,Medical History/Concurrent Conditions: Goiter; Hashimoto's disease; SARS-CoV-2 test positive; Thyroidectomy partial,,,"['Biopsy thyroid gland normal', 'Blood test', 'Diagnostic aspiration', 'Goitre', 'SARS-CoV-2 test positive', 'Sensation of foreign body', 'Thyroid function test normal']",1,PFIZER\BIONTECH,OT 995233,FL,76.0,F,"tested positive; tested positive; being a little tired/she was tired after it; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: 30Apr2021) solution for injection, via an unspecified route of administration on 15Jan2021 at a single dose for Covid-19 immunization. Medical history included hearing aid. There were no concomitant medications. The patient reported she received her first dose on Friday 15Jan2021 and she lost her sense of smell and taste on Sunday 17Jan2021 and she went and got tested today, Monday 18Jan2021 and her rapid test was positive (Covid test). her taste and smell ability disappeared. She stated that yesterday at 3:30PM all of sudden that her taste and smell ability disappeared. Stated that she just had a rapid test done. Stated that she had not felt bad and had no symptoms before the shot. Patient wanted to know if they had any reactions like this. Stated that she will know more when the test comes back, and she will hear shortly. Patient stated that she was tired after it (Jan2021). She was being a little tired. Stated she has a hearing aid which she had prior to getting the vaccine. Outcome of the events lost her sense of smell and taste/her taste and smell ability disappeared were not recovered, while outcome of the other events was unknown. No follow-up activities are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Hearing aid user,,,"['Ageusia', 'Anosmia', 'COVID-19', 'Fatigue', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 995234,,,F,"Tested positive shortly thereafter; Tested positive shortly thereafter; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dose of the vaccine on 04Jan2021 and then on an unspecified date in Jan2021, the patient tested positive thereafter. She stated that she is now negative for COVID and wants to know if she needs to wait to get the 2nd dose of the vaccine. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 995239,,73.0,F,"she thinks she broke the sweat/big sweat; couldn't eat anything/was not even eating; She had the chills; nausea; She had a terrible headache; Feeling freezing cold; she was going to faint; She thought she was losing her mind; slight pain in her arm/sore arm/sore spot; She feels weak, and is still weak; She couldn't walk; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283) via an unspecified route of administration in the left arm on 10Jan2021 at single dose for COVID-19 immunization. There was no medical history. There were no concomitant medications. The patient had the first dose of the vaccine on 10Jan2021 and didn't have a reaction, but had a slight pain in her arm on 10Jan2021. Her sore arm started on 11Jan2021. There was a sore spot and when she would pick up her arm it was sore and achy. No pain, but sore and achy. It lasted for a day or two. She didn't have any symptoms until Saturday the 16Jan2021, this past Saturday she thought she was dying. She had chills, nausea, feeling freezing cold, and had a headache. She thought she was losing her mind. The headache just stopped today. She had the chills that would not stop and she thinks she broke the sweat on Sunday (17Jan2021). She had a little nausea and couldn't eat anything on 16Jan2021. She had a terrible headache, which just stopped about 2 hours ago. She stated she must have to take 10 Tylenol over the course of time, every 4 hours. On Saturday 16Jan2021 she was just laying on the floor in pain. She was not even eating, just drinking water. All of her symptoms stopped this morning around 5 AM (18Jan2021). She had a big sweat. She is unsure if she had a fever because she does not have a thermometer. She is unsure if she has recovered completely from these symptoms. She feels weak, and is still weak (on Jan2021). She cannot go out or get dressed or shower. She is not strong enough. She is just sitting up now, no longer laying in bed. She couldn't walk (on Jan2021) and was afraid she was going to faint on 16Jan2021. She can walk a little bit now and feels a little bit better. She has been out of it for three days, She hasn't felt good. She asked if side effects can appear 6 days later? Is this normal to have a reaction 1 week after getting it? She asked are the side effects worse after the second dose? She asked is this Covid or side effects, what are the COVID symptoms? She asked should she take the second one if she had these side effects? Caller clarifies this is the Pfizer COVID Vaccine. Whoever vaccinated her did not give her the paper about it afterwards. Her neighbor brought it to her cause they went together. She did not realize she could experience these things. She did not expect them a week after getting the vaccine. She thought she had COVID. She asks, ""do you think I have COVID?"" She is just now getting better and it has been 3 days of experiencing these symptoms. Should she get the second vaccine? She is trying to do the right thing. Event outcome of chills, nausea, feeling freezing cold, and headache was recovered on 18Jan2021, for was going to faint and couldn't walk was recovering, for weak was not recovered, while for others was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Chills', 'Decreased appetite', 'Dizziness', 'Fear', 'Feeling abnormal', 'Feeling cold', 'Gait inability', 'Headache', 'Hyperhidrosis', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Nausea', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 995244,,,M,"tested positive to SARS-COV2; tested positive to SARS-COV2; This is a spontaneous report from a contactable consumer (reported for himself). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive to SARS-COV2 on 08Jan2021. Today (18Jan2021), he got his appointment to get the second dose. He just wanted to know if he should go to get it or not. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/08/2021,11.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 995249,FL,,M,"patient received the first vaccine and then tested positive for Covid.; patient received the first vaccine and then tested positive for Covid.; This is a spontaneous report from a contactable nurse. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection NDC number: 59267-1000-2, lot number: EL1283, expiry date: Apr2021), via an unspecified route of administration on unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter is a nurse in (City name) who said that they have a patient received the first vaccine and then tested positive for Covid. She was calling to ask what they should do about it, and should the patient get the 2nd dose? Nurse states that the office called her and said that the patient was now positive with Covid, and asked her what they should do and if the patient would be able to get the 2nd dose. Nurse stated she had no idea, which is why she called, but she did tell them that it wasn't from the vaccine; that the patient must have had it prior to getting the vaccine. The nurse states that they only received 1 Lot at their facility, so the patient's first dose must have been of that same Lot, which was EL1283. States that she remembers that the Expiry was Apr2021. Caller was able to get into the patient's chart while on hold and provided the patient's date of birth and the NDC number for the vaccine after being introduced. The outcome of events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 test positive and suspected LOE due to temporal relationship. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 995251,,,M,"contracted Covid; contracted Covid; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was due for his second dose but was in the middle of the period where he contacted COVID on an unspecified date. The outcome of the event was unknown. Information on lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,,,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 995253,,,F,"acquired covid19 had mild to moderate symptoms; acquired covid19 had mild to moderate symptoms; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The physician reported that the patient was vaccinated 2 and a half weeks ago and a week ago, in Jan2021, she acquired Covid19 had mild to moderate symptoms. Event was reported as non-serious. The physician wanted to know when the 2nd dose should be given. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/01/2021,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 995254,MA,,F,"she has an infection; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 19Jan2020, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified) via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced an infection. It was reported that the patient was scheduled for minor surgery next week. She was going to be given antibiotics and she wants to make sure that one won't interfere with the vaccination. She was going to be on two or three antibiotics because she has an infection. She wanted to make sure no issue. Patient clarified that she was looking for information about COVID vaccine and antibiotics and just wanted the medical information to pass along to her doctor. Outcome of event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,,,UNK,,,,,,['Infection'],1,PFIZER\BIONTECH, 995255,TX,16.0,M,"He passed out; His blood sugar was 143; This is a spontaneous report from a contactable consumer (patient's parent). A 16-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3247) via an unspecified route of administration on the right arm on 17Jan2021 at single dose for COVID-19 immunisation. Medical history included hypopituitarism. Concomitant medication included somatropin (NORDITROPIN) taken for hypopituitarism. He passed out (emergency room visit needed) on 17Jan2021, his blood sugar was 143 in Jan2021. Caller stated that her son received his first dose of the Pfizer COVID vaccine on 17Jan2021, stated he passed out. Caller stated they had to drive 3 hours away to get the vaccine and wanted to know that if because he experienced this after the first dose if it would be possible to find somewhere closer to home to get the second vaccine. Caller stated she is in the trial as an adult, that she reached out to her trial coordinator and they told her that they can only administer to persons in the trial. Son feels like maybe there is a drug interaction, caller stated she was not sure about this. Stated after her son passed out, they called an ambulance, states the Medic watched him for about 45 minutes, stated they ran some tests in Jan2021, he did go home that day. His blood sugar was 143 in Jan2021. Heart Rate monitor in Jan2021 she couldn't see so is unsure of the readings. The outcome of the event passed out was recovered on 17Jan2021, of other remain event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/17/2021,01/01/2021,,UNK,NORDITROPIN,,Medical History/Concurrent Conditions: Hypopituitarism,,,"['Blood glucose normal', 'Heart rate', 'Loss of consciousness']",1,PFIZER\BIONTECH, 995258,MI,,F,"got COVID-19.; got COVID-19.; This is a spontaneous report from a contactable nurse. This nurse reported for a female patient (daughter) with unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was also a nurse, she had the shot and the got COVID-19 on unspecified date. The outcome of event was unknown. Information on the batch/lot number has been requested.; Sender's Comments: Based on the limited information available, a causal relationship between event ""got COVID-19"" (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)cannot be completely excluded. The case will be reevaluated should additional information become available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['COVID-19'],UNK,PFIZER\BIONTECH, 995285,MI,64.0,F,"Normal sinus rhythm but throwing PVCs; Elevated pulse with chest tightness; Elevated pulse with chest tightness; A little atelectasis in lower left lung; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the first dose of bnt162b2 (lot number: EL3248), via an unspecified route of administration in left deltoid on 14Jan2021 09:00 at single dose for covid-19 immunization. Medical history included ongoing does not have a thyroid; allergies/intolerance to gluten and dairy, allergies to molds, dust and some seasonal allergies; all ongoing. Concomitant medication included levothyroxine from Feb2013 to unspecified date, from unspecified date and ongoing for ""does not have a thyroid"". The patient previously took codeine and experienced allergic reaction occurred at 13 years of age with unknown cough syrup with codeine, levaquin and experienced allergic reaction occurred probably while she was in her 20s (age in years). She had fallen asleep on the couch about 9:00 pm on 14Jan2021. She woke up about 9:30 pm on 14Jan2021 and had an elevated pulse with chest tightness. She had to go to the emergency room in response to elevated pulse with chest tightness. In the emergency room they were not able to do anything other than hydrate her and all of that but it took about 12-13 more hours for her elevated pulse to come down (15Jan2021). Her biggest question was that she saw where some reactions are fast heart beat but she was kind of surprised at how long after the dose was administered that she had onset of the elevated pulse. She saw Cardiologist 18Jan2021 related to this event and the Cardiologist was a little baffled by the event. She reported event as improved, although she still has a little bit of tightness in her chest which goes in a little bit of phases. The Cardiologist told her to still take the second dose as scheduled of the Pfizer COVID-19 Vaccine. She did not see her family doctor, she saw the Cardiologist only as referred after emergency room visit. She was not admitted to the hospital; she was treated and kept under observation in the emergency room for about 5.5 hours. She has a stress test scheduled for next week. She is planning to still get the second dose as scheduled of Pfizer COVID-19 Vaccine but she is a little scared to get it due to this adverse event. She thought the events were related with the vaccine, she had no problem prior to getting the vaccine. On 14Jan2021, pulse was 146 beats per minute which she checked with a pulse oximeter machine she has at home so she knows it is accurate; Chest x-ray: She reported that result of a little atelectasis in lower left lung was a little weird. On 18Jan2021, the EKG result was Normal sinus rhythm but throwing PVCs. She reported she knows her thyroid lab is normal because it was checked in the emergency room during visit starting 14Jan2021. The outcome of the events elevated pulse with chest tightness was recovering, other events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,UNK,LEVOTHYROXINE,Allergy to molds; Dairy intolerance; Dust allergy; Gluten intolerance; Seasonal allergy; Thyroid disorder,,,,"['Atelectasis', 'Chest X-ray abnormal', 'Chest discomfort', 'Electrocardiogram abnormal', 'Fear', 'Heart rate increased', 'Thyroid function test normal', 'Ventricular extrasystoles']",1,PFIZER\BIONTECH, 995286,MD,54.0,F,"heart rate 160 (elevated); she had an allergic reaction to the vaccine; fever of 102; chills; irritation in throat; Diarrhea; felt funny; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (BNT162B2 reported as Pfizer COVID 19 vaccine; lot number: EL3302; expiration date: unknown), via an unspecified route of administration left arm on 15Jan2021 09:30 at a single dose (reported as unknown dosage with a needle to left arm one time) to prevent Covid 19 and build up antibodies to Covid 19 (COVID-19 immunization). The patient has no medical history and concomitant medications. The patient reported that last Friday (15Jan2021) at 9:30 she took the first dose of vaccine and felt funny, so she waited for 15 minutes. She mentioned that she had not eaten before so they gave her glucose tablets. She then mentioned that later on that night (15Jan2021) that she had a fever of 102 [unit unspecified], elevated heart rate of 160 [unit unspecified], had chills and felt like she had Covid. She further stated that she had irritation in her throat that started after the vaccine. She stated that her doctor mentioned that she may be positive for Covid 19 and did not know it before she had the vaccine. The patient mentioned that she had the nasal swab for Covid and they drew her blood on an unspecified date, but all came back negative. She was told that she had an allergic reaction to the vaccine. She added that she had no symptoms prior to the vaccine. The patient reported that she has to go back for the second Pfizer Covid 19 vaccine on 05Feb2021. The patient received treatment included prednisone, diphenhydramine (BENADRYL) and was given an epinephrine injection (EPIPEN) to bring home. She also was given acetaminophen (TYLENOL) for fever. She was given fluids to try to bring everything down. She added that she was given famotidine (PEPCID) for her stomach due to diarrhea on 15Jan2021 that she is still taking. The outcome of the events allergic reaction and felt funny were unknown, as for diarrhea was not recovered, for the event irritation in throat was recovered on 15Jan2021 while the outcome of the other events was recovered on 17Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Blood test normal', 'Chills', 'Diarrhoea', 'Feeling abnormal', 'Heart rate increased', 'Pyrexia', 'SARS-CoV-2 test negative', 'Throat irritation']",UNK,PFIZER\BIONTECH, 995289,FL,,F,"stomach bug; had history of 2 radioactive ablations; had history of 2 radioactive ablations; like a dysentery; constant diarrhea; completely exhausted/tired; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EH9899, expiration: 31Mar2021), via an unspecified route of administration in left arm on an unspecified date at a single dose for COVID-19 prophylaxis. Medical history included ongoing Barrett's esophagus, ongoing esophageal hernia, 2 radioactive ablations, ulcer, ongoing high cholesterol, ongoing arthritis, and ongoing esophageal problems. She has had a lot of esophageal issues, had history of 2 radioactive ablations. Concomitant medications included ongoing omeprazole for esophageal problems, ongoing atorvastatin to prevent high cholesterol, and ongoing paracetamol (TYLENOL) for arthritis. The patient reported that she received the vaccine on Saturday morning at 0900 (unspecified date). The patient's arm hurt on 16Jan2021. On 17Jan2021, she has had constant diarrhea. She is not panicked. She wants to know if this is from the vaccine or if she has a stomach bug. She was completely exhausted on 17Jan2021, and her arm hurt so bad. She stayed in bed. She is not as tired now. She said that her arm hurt with the flu shot and other shots too (unspecified date). She said that she was not worried about it. With regards to diarrhea, she said that Sunday was like a dysentery, but it is a little bit better today. She is not going out or exercising because she is tired. Her second dose supposed to be on 06Feb2021. She said that she does not like medication or shots. The patient is recovering from events constant diarrhea (like a dysentery) and completely exhausted/tired; recovered from arm hurt on 18Jan2021; while unknown outcome for the remaining event.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,01/16/2021,,UNK,OMEPRAZOLE; ATORVASTATIN; TYLENOL,Arthritis; Barrett's esophagus; Esophageal disorder; Esophageal hernia; High cholesterol,Medical History/Concurrent Conditions: Radiofrequency ablation of esophagus; Ulcer,,,"['Diarrhoea', 'Dysentery', 'Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH, 995290,CA,32.0,F,"Shingles behind left ear the morning after (31Dec2020)Vaccine received; This is a spontaneous report from a contactable other health professional (patient). A 32-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: El1284), via an unspecified route of administration on 30Dec2020 16:30, at left arm, at single dose for covid-19 immunization. Medical history included atopic dermatitis (eczema). No known allergies. Concomitant medication included melatonin. The patient experienced shingles behind left ear the morning after (31dec2020) vaccine received on 31Dec2020 09:00. Event resulted in Emergency room. The patient underwent lab tests and procedures which included covid test Nasal Swab (Fulgent Genetics) post vaccination: negative on 08Jan2021. Therapeutic measures were taken as a result of shingles behind left ear the morning after (31Dec2020) includes oral Antibiotics, oral Antivirals, antibiotic shot. The outcome of the event was recovered on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.; Sender's Comments: Based solely on a chronological association, a causal relationship between event ""patient experienced shingles behind left ear the morning after vaccination"" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,WRK,MELATONIN,,Medical History/Concurrent Conditions: Atopic dermatitis,,,"['Herpes zoster', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 995333,OH,62.0,F,"After my second dose injection and on Friday night I experienced left arm soreness, chills, could not get warmed up. On 01-30-2021, I felt very lethargic, I had headaches, and my fever spiked up to 100.8F and was drenched in sweat. I took Tylenol for the pain and body aches. On 01-31-2021, I started to feel a bit better and was little tired. I continued with left arm soreness at a pain level of 2.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,UNK,None reported,None reported,None reported,,"Latex, Kiwi, Demerol, Aspirin, Bactrim, Fluoro (iodine)","['Chills', 'Fatigue', 'Feeling cold', 'Headache', 'Hyperhidrosis', 'Lethargy', 'Pain', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 995346,IL,61.0,M,"Tightness in chest several times about 1 week and 2 weeks after 1st round. Difficulty sleeping on left side 20 and 21 days following 1st round. Severe pain with inhaling AM of 22 day. Diagnosed at ER Hospital, with DVT left calf and PE both lungs. On Heparin IV for 4 days inpatient. Now on Eloquis 10mg BID for a week, 5mg BID thereafter.",Not Reported,,Yes,Yes,4.0,Not Reported,U,01/05/2021,01/27/2021,22.0,PVT,none,none,none,,CT die marker,"['Blood test', 'Chest discomfort', 'Computerised tomogram thorax', 'Deep vein thrombosis', 'Echocardiogram', 'Electrocardiogram', 'Insomnia', 'Myocardial necrosis marker', 'Painful respiration', 'Pulmonary embolism', 'Scan with contrast', 'Sleep disorder', 'Ultrasound scan', 'Ventilation/perfusion scan']",2,MODERNA,IM 995367,OH,82.0,M,"PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH SYMPTOMS OF FEVER, CHILLS, AND GENERAL MALAISE TWO DAYS POST VACCINATION. PATIENT HAS HISTORY OF COVID+ IN NOVEMBER 2020. PATIENT WAS NOT GIVEN MEDICAITON AT HOME PRIOR TO ARRIVING TO EMERGENCY DEPARTMENT. PATIENT HAS PRIOR HISTORY OF SHORTNESS OF BREATH AND REQUIRES OXYGEN WHILE HOSPITALIZED BUTH HAS NOT HAD ANY ARTIFICIAL OXYGENATION SINCE. NO COUGH, NO SHORTNESS OF BREATH REPORTED AT EMERGENCY DEPARTMENT. PATIENT ADMITTED FOR FURTHER WORKUP. PATIENT STAYED 1 NIGHT - RECEIVED 2 DOSES OF CEFTRIAXONE IVPB FOR SUSPECTED PYELONEPHRITIS, WHICH WAS EVENTUALLY RULED OUT. PATIENT FOUND TO HAVE AKI. PATIENT DISCHARGED ON 1/28/2021 IN STABLE CONDITION AND RENAL FUNCTION IMPROVI",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/25/2021,01/27/2021,2.0,PVT,,,,,,"['Acute kidney injury', 'Basophil count decreased', 'Basophil percentage', 'Bilirubin urine', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine increased', 'Blood glucose', 'Blood glucose increased', 'Blood lactic acid', 'Blood lactic acid normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea increased', 'Blood urea nitrogen/creatinine ratio', 'Blood urine present', 'Brain natriuretic peptide normal', 'Carbon dioxide normal', 'Cardiomegaly', 'Chest X-ray', 'Chills', 'Electrocardiogram', 'Eosinophil count normal', 'Full blood count', 'Glucose urine absent', 'Granulocyte count', 'Haematocrit decreased', 'Haemoglobin decreased', 'Lymphocyte count decreased', 'Lymphocyte percentage decreased', 'Malaise', 'Mean cell haemoglobin concentration decreased', 'Mean cell haemoglobin increased', 'Mean cell volume increased', 'Mean platelet volume normal', 'Metabolic function test', 'Monocyte count decreased', 'Monocyte count increased', 'Monocyte percentage increased', 'Neutrophil count normal', 'Neutrophil percentage', 'Nitrite urine absent', 'Platelet count decreased', 'Protein urine present', 'Prothrombin time prolonged', 'Pyrexia', 'Red blood cell anisocytes present', 'Red blood cell count decreased', 'Red cell distribution width increased', 'Specific gravity urine normal', 'Troponin T normal', 'Urine ketone body absent', 'Urobilinogen urine increased', 'White blood cell count decreased', 'White blood cells urine positive', 'pH urine normal']",1,PFIZER\BIONTECH,IM 995373,NY,31.0,F,"Pain and soreness was felt the fist 2 days after vaccine however on the 6th day pain 20/10, numbness, all the way to thumb was felt on L arm, swelling, redness, itching, hives and pain only on L arm and temp of 99.4. Pain in L thumb still hurts even more than a month later sometimes is even hard to pop out pill or open or hold stuff with that hand and thumb. Benadryl ibuprofen tylenol was taken for 1st and second dose. Did not help much!!",Not Reported,,Not Reported,Not Reported,,Yes,U,12/30/2020,01/06/2021,7.0,PVT,,,,,,"['Erythema', 'Hypoaesthesia', 'Mobility decreased', 'Muscular weakness', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Urticaria']",1,MODERNA,IM 995377,,68.0,F,Patient was vaccinated on 1/12/21. She developed symptoms of COVID and diagnosed on 1/22. She was hospitalized for moderate coronavirus pneumonia and hypovolemic hyponatremia,Not Reported,,Not Reported,Yes,,Not Reported,,01/12/2021,01/22/2021,10.0,PVT,,,diabetes,,,"['COVID-19 pneumonia', 'Hyponatraemia', 'Hypovolaemia']",UNK,PFIZER\BIONTECH, 995379,WY,23.0,F,"I had severe headaches, abdominal pain, chills and fever 104. Later that week diagnosed with the flu and hive reaction at the injection site.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/28/2020,12/28/2020,0.0,PUB,"Metoprolol 25 mg, Folic Acid(over the counter), Prenatal Vit",No,Lupus,,"Chlorine Bleach, Mushrooms, Coconut","['Abdominal pain', 'Blood test', 'Chills', 'Headache', 'Influenza', 'Influenza virus test positive', 'Injection site urticaria', 'Laboratory test', 'Pyrexia', 'Renal function test', 'SARS-CoV-2 test negative']",1,MODERNA,IM 995380,MD,79.0,F,"Chest palpitations, thickness of tongue. Medic administered epinephrine injection and benadryl though IV in arm in tent on site. Taken by ambulance to hospital and observed for over 4 hours.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/30/2021,01/30/2021,0.0,UNK,"Irbesartan, Amlodipine, Atenolol, Simvastatin, Methylprednisolone, Aspirin 325mg, Potassium, Tylenol extra strength, Aspercreme, Vitamin D3, Calcium.",Sciatica and groin pain.,Lower back pain. High blood pressure,,Ciprofloxacin,"['Blood test', 'Electrocardiogram', 'Palpitations', 'Tongue disorder']",UNK,PFIZER\BIONTECH,SYR 995382,NV,45.0,F,"1/20/21 developed fever of 105 degrees, after Tylenol and Advil dropped to 104 which continued for 6 days. Also had nausea and vomiting which led to dehydration, hospitalized on 1/25/21 with Acute Cholecystitis without calculus, Hyperbilirubinemia, UTI, Acute kidney injury secondary to dehydration, Pyelonephritis. Surgery done for Cholecystectomy. 2 units of blood also administered.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/19/2021,01/20/2021,1.0,PVT,None,None,None,,None,"['Acute kidney injury', 'Cholecystectomy', 'Cholecystitis acute', 'Dehydration', 'Hyperbilirubinaemia', 'Laboratory test', 'Nausea', 'Pyelonephritis', 'Pyrexia', 'Transfusion', 'Urinary tract infection', 'Vomiting']",2,MODERNA,IM 995395,VA,82.0,F,passed out without warning around 10pm. woke up on floor. couldn't move right leg. slept on floor all night.,Not Reported,,Not Reported,Yes,2.0,Yes,N,01/27/2021,01/27/2021,0.0,PUB,high blood pressure medicine and high cholesterol medicine,none,chronic UTIs,flu,shellfish,"['Loss of consciousness', 'Mobility decreased']",1,MODERNA,IM 995404,WA,25.0,M,"Patient awoke the morning following the vaccination experiencing double vision, difficulty focusing vision. He presented to opthalmologist on 1/30/21 and was diagnosed with a L 6th nerve palsy. His symptoms have persisted and are accompanied by a HA.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/25/2021,01/26/2021,1.0,OTH,"Ibuprofen, Lidocaine 5% patch",None,None,,None,"['Blood thyroid stimulating hormone', 'Diplopia', 'Full blood count normal', 'Gaze palsy', 'Headache', 'Metabolic function test', 'Ophthalmological examination abnormal', 'SARS-CoV-2 test negative', 'VIth nerve paralysis', 'Vision blurred']",1,MODERNA,IM 995411,OH,66.0,F,Patient developed Belly palsy with right side facial droop after receiving 2nd shot of her Moderna vaccine,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/27/2021,01/29/2021,2.0,PVT,"Lipitor, celexa, fenofibrate, Lasix, gabapentin, lantus, Elavil",,"Hypertension, diabetes mellitus type 2, hyperlipidemia, hypothyroidism, GERD, anxiety/depression., obese",,,"['Angiogram cerebral normal', 'Arteriogram carotid normal', 'Computerised tomogram head normal', 'Facial paralysis', 'Magnetic resonance imaging brain normal']",2,MODERNA,IM 995415,TX,57.0,F,"Patient felt unwell and had a fever on Wednesday (1/27) and went home early from work. On Thursday morning (1/28), she threw up once and then laid down to rest. Her son reported seeing her that morning with the episode of emesis prior to her getting on the couch. Son reports that when he came home at 5pm, she was asleep on the couch. Teenage daughter reports patient had been asleep on couch all day. Son tried to wake patient up and she was disoriented and lethargic. Daughter (reporter) was contacted to come see patient and on arrival to house (5;45pm), noted patient was confused, lethargic, febrile (104), and hypoxic at 83% on room air with portable pulse oximeter. Patient was able to stand and ambulate to car with assistance and was driven to Emergency Department for evaluation. At emergency department, patient was hypotensive 80/40s but was able to increase blood pressure with 3 L of normal saline to blood pressure of 90/50s. See all tests performed and results below. Patient received antibiotics, anti-virals and tylenol for fever of 102.7 while in emergency department. She was admitted to ICU that evening at approximately 11pm and had a foley catheter placed overnight due to decreased urine output. patient continued to have low blood pressure through morning of 1/28 and was placed on levophed for blood pressure control at approx 10 am. Her blood pressures continued to improve through afternoon and levophed was titrated down and then discontinued around 4pm. She continued to received antibiotics for 24 hours after initiation and continued acyclovir during course of hospitalization and is still receiving doses on 2/2. Patient's initial mental status was confused, lethargic, and unable to communicate. She was intermittently oriented to herself only and would not follow commands. She would localize painful stimuli. Her mental status began to improve on Saturday when she started to become more awake but was still unable to follow commands or communicate clearly. She was moved from ICU to IMCU (step down unit) on Saturday once mental status was improving and blood pressure was stabilized. Her mental status continued to improve from Saturday 1/ 30 to Tuesday 2/2 (current). She began to have diarrhea on Saturday afternoon that continued through Monday and occurred every 1-2 hours. She was unable to stand or move body on her own and had to be assisted by staff to be cleaned. She remained awake and alert and was able to get up and walk on Monday and began to eat. She continued acyclovir treatment pending HSV meningitis panel PCR results (still pending currently 2/2). Mental status not currently at baseline but continuing to improve. She is also still experiencing generalized weakness. Hospitalist team and infectious disease doctors report she should be discharged tomorrow (2/3). No source for confusion and hypotension has been found at this time. Physician team think HSV is unlikely but awaiting final diagnosis until test is resulted.",Not Reported,,Yes,Yes,6.0,Not Reported,Y,01/22/2021,01/27/2021,5.0,PVT,1200 mg calcium with vitamin D,none,none,,None,"['Allodynia', 'Ammonia normal', 'Angiogram', 'Arteriogram coronary normal', 'Asthenia', 'Bladder catheterisation', 'Blood creatine phosphokinase normal', 'Blood culture negative', 'Blood glucose normal', 'Blood lactic acid normal', 'CSF culture negative', 'CSF glucose normal', 'CSF protein increased', 'CSF white blood cell count increased', 'Chest X-ray normal', 'Communication disorder', 'Computerised tomogram abdomen normal', 'Computerised tomogram head normal', 'Confusional state', 'Cortisol normal', 'Culture urine negative', 'Diarrhoea', 'Disorientation', 'Drug screen negative', 'Dysstasia', 'Electroencephalogram normal', 'Fibrin D dimer increased', 'Full blood count normal', 'Gait disturbance', 'Hypersomnia', 'Hypotension', 'Hypoxia', 'Intensive care', 'Lethargy', 'Lumbar puncture normal', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging normal', 'Malaise', 'Metabolic function test', 'Metabolic function test normal', 'Mobility decreased', 'Movement disorder', 'Pyrexia', 'Respiratory viral panel', 'SARS-CoV-2 test negative', 'Somnolence', 'Stool analysis normal', 'Unresponsive to stimuli', 'Urine analysis', 'Urine output decreased', 'Viral test negative', 'Vomiting', 'White blood cell count increased']",2,MODERNA,IM 995419,TX,37.0,F,"Shortness of breath, abnormal ECGs, lack of oxygen to the heart, numbness of legs and arms, tachycardia (130-160) for over 12 hours, difficulty breathing, bilateral pin point pain in legs, dizzy, syncopal convusions, fainting, hyperventilation, vomiting, chills, headache, heart pain, fever, kidney pain",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/26/2021,01/26/2021,0.0,PVT,vitamin d3,"Paroxysmal Nocturnal Hemoglobinuria (PNH), pancytopenia",Paroxysmal Nocturnal Hemoglobinuria (PNH),,"latex, pineapple, onions","['Angina pectoris', 'Angiogram', 'Blood gases', 'Blood lactic acid', 'Blood test', 'Chest X-ray', 'Chills', 'Dizziness', 'Dyspnoea', 'Electrocardiogram abnormal', 'Electroencephalogram', 'Full blood count', 'Glomerular filtration rate', 'Headache', 'Hyperventilation', 'Hypoaesthesia', 'Metabolic function test', 'Myocardial ischaemia', 'Pain in extremity', 'Pulmonary embolism', 'Pyrexia', 'Renal pain', 'SARS-CoV-2 test', 'Smear test', 'Syncope', 'Tachycardia', 'Troponin', 'Vomiting']",2,MODERNA,IM 995441,TX,94.0,M,The vaccine was given on Monday. Tuesday afternoon he developed weakness in both legs and could not stand up. This was a new development; he had neuropathy in one leg but he had been able to stand up and walk three hours before. He was helped to the bathroom. He said he felt better and might want to stand up again. He was helped to bed. He was found dead around 5:30 Wednesday morning. He was 94 years old and had a lot of medical conditions. No one has indicated his death had anything to do with the vaccine. I'm sure it's just a coincidence that he died so soon after receiving the vaccine,Yes,01/27/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,SEN,"Atorvastatin, Eliquis, Donepezil HCL, Aspirin EC, Fluticasone Prop, Losartan Potas, Desonide, Levothyroxine, Melatonin, Potassium Cl, Cerovite Senior, Vitamin B-12, Vitamin D3 5,000 Unit, Docusate Sodium, Latanoprost OS, Torsemide",None,"Mild Cognitive Impairment, Hypothyroidism, Coronary Artery Disease, Hyperlipidemia, Hypertension, Neuropathy, Vertigo, Vitamin B deficiency",,None,"['Death', 'Dysstasia', 'Mobility decreased', 'Muscular weakness']",2,PFIZER\BIONTECH,SYR 995460,NH,85.0,M,Vaccine-1/7 Covid positive-1/10 Hospitalized-1/17 Deceased-1/25,Yes,01/25/2021,Not Reported,Yes,7.0,Not Reported,N,01/07/2021,01/16/2021,9.0,SEN,Levothyroxine Sodium Tablet 50 MCG daily Cholecalciferol Tablet 2000 UNIT daily Metoclopramide HCl Tablet 5 MG 4 times a day Tylenol Tablet 325 MG as needed Q4hrs Senokot S Tablet 8.6-50 MG (Sennosides-Docusate Sodium) 2 tabs daily Atorv,N/A Covid positive on 1/10 Hospitalized 1/16 Deceased 1/25,"HEMIPLEGIA AND HEMIPARESIS FOLLOWING UNSPECIFIED CEREBROVASCULAR DISEASE AFFECTING RIGHT DOMINANT SIDE (I69.951) WEAKNESS (R53.1) UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE (F03.90) PNEUMONIA, UNSPECIFIED ORGANISM (J18.9) UNSPECIFIED ABNORMALITIES OF GAIT AND MOBILITY (R26.9) HEART FAILURE, UNSPECIFIED (I50.9) CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED (J44.9) ENCOUNTER FOR SURGICAL AFTERCARE FOLLOWING SURGERY ON THE DIGESTIVE SYSTEM (Z48.815) ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS (I25.10) ESSENTIAL (PRIMARY) HYPERTENSION (I10) ACUTE EMBOLISM AND THROMBOSIS OF DEEP VEINS OF RIGHT UPPER EXTREMITY (I82.621) APHASIA FOLLOWING UNSPECIFIED CEREBROVASCULAR DISEASE (I69.920) DYSPHAGIA FOLLOWING UNSPECIFIED CEREBROVASCULAR DISEASE (I69.991) FLUID OVERLOAD, UNSPECIFIED (E87.70) DYSPHAGIA, OROPHARYNGEAL PHASE (R13.12) COVID-19 (U07.1) SPONDYLOLYSIS, CERVICAL REGION (M43.02) HYPERLIPIDEMIA, UNSPECIFIED (E78.5) PNEUMONIA, UNSPECIFIED ORGANISM (J18.9) VITAMIN D DEFICIENCY, UNSPECIFIED (E55.9) CELLULITIS OF RIGHT UPPER LIMB (L03.113) ENCOUNTER FOR ATTENTION TO COLOSTOMY (Z43.3) INCONTINENCE WITHOUT SENSORY AWARENESS (N39.42) OTHER PULMONARY EMBOLISM WITHOUT ACUTE COR PULMONALE (I26.99) OTHER SPECIFIED SOFT TISSUE DISORDERS (M79.89) OTHER SPECIFIED SYMPTOMS AND SIGNS INVOLVING THE DIGESTIVE SYSTEM AND ABDOMEN (R19.8) VASCULAR DISORDER OF INTESTINE, UNSPECIFIED (K55.9) DYSPHAGIA, UNSPECIFIED (R13.10) HYPOKALEMIA (E87.6) GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS (K21.9) OTHER DYSPHAGIA (R13.19) VERTEBRO-BASILAR ARTERY SYNDROME (G45.0) ADJUSTMENT DISORDER WITH MIXED DISTURBANCE OF EMOTIONS AND CONDUCT (F43.25) BENIGN NEOPLASM OF COLON, UNSPECIFIED (D12.6) CEREBROVASCULAR DISEASE, UNSPECIFIED (I67.9) DISORDER OF KIDNEY AND URETER, UNSPECIFIED (N28.9) HEMATEMESIS (K92.0) HYPOTHYROIDISM, UNSPECIFIED (E03.9) LONG TERM (CURRENT) USE OF ANTICOAGULANTS (Z79.01) METABOLIC ENCEPHALOPATHY (G93.41) OTHER HYPERLIPIDEMIA (E78.4) OTHER SPECIFIED MENTAL DISORDERS DUE TO KNOWN PHYSIOLOGICAL CONDITION (F06.8) PERSONAL HISTORY OF OTHER VENOUS THROMBOSIS AND EMBOLISM (Z86.718) PERSONAL HISTORY OF TRANSIENT ISCHEMIC ATTACK (TIA), AND CEREBRAL INFARCTION WITHOUT RESIDUAL DEFICITS (Z86.73) RESPIRATORY FAILURE, UNSPECIFIED, UNSPECIFIED WHETHER WITH HYPOXIA OR HYPERCAPNIA (J96.90) DIFFICULTY IN WALKING, NOT ELSEWHERE CLASSIFIED (R26.2) PNEUMONIA, UNSPECIFIED ORGANISM (J18.9)",,Vancomycin,"['Death', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 995462,NC,71.0,M,"Seizure, low sodium, confusion",Not Reported,,Yes,Yes,3.0,Not Reported,Y,01/27/2021,01/30/2021,3.0,PUB,"Atorvastatin, vitamin C, multivitamin",None,High Cholesterol,,None,"['Blood sodium decreased', 'Confusional state', 'Seizure']",1,PFIZER\BIONTECH,SYR 995473,SC,65.0,F,"Starting on 1/17/21 had fever of 101.6, 1/18/21 fever of 101.2, 1/19/21 fever of 102.6. From 1/19-1/23 she had defervesed to normal temp. Afternoon of 1/23/21 temp 101.4, 1/24/21 fever of 103 and 101. On 1/25/21 the nurses called the doctor and said that she was lethargic. Dr. found her to be hypotensive, lethargic, tacchycardic, They sent her to the ER. She also had during that day they found her with neck pain with movement, chills and fever. From 1/25-today she is still admitted to the hospital. They found her to have staph aureus sepsis - source unknown, encephalopathy related to sepsis, they did rule out meningitis, hyponatremia, UTI with E-coli and some staph, urinary retention, rhabdomyalisis with acute kidney injury and dehydration. They are treating her with antibiotics, getting better but still hospitalized.",Not Reported,,Not Reported,Yes,8.0,Not Reported,N,01/15/2021,01/17/2021,2.0,OTH,"Fosamax, Lipitor, Zyrtec, Thorazine, Prozac, Neurontin, Januvia, Jardiance, Lantus, Synthroid, Lisinopril, Metformin, Toprol XL, Zyprexa, Phenobarbitol, Murilax, sodium chloride, vitamin C, vitamin D3, Ativan prn, milk of magnesium prn, Her","No acute illness, does get chronic chemotherapy on an intermittent basis.","Schizoaffective disorder - unspecified, diabetes mellitus - type II, hypertension, hypothyroidism, diastolic heart failure, chronic hyponatremia, seizure disorder, anemia - unspecified, gastroesophageal reflux disease, history of left breast cancer with metastatic to the liver, status post left mastectomy, status post port placement, history of recurrent UTI's, history of patella fracture that has healed, history of osteomyelitis in the thoracic spine that has resolved, allergic rhinitis, constipation, osteoporosis, hyperlipidemia, vitamin D deficiency.",,Valproic acid.,"['Acute kidney injury', 'Blood calcium decreased', 'Blood calcium normal', 'Blood chloride decreased', 'Blood creatinine increased', 'Blood glucose increased', 'Blood potassium normal', 'Blood sodium decreased', 'Blood urea increased', 'Carbon dioxide decreased', 'Chills', 'Culture urine positive', 'Dehydration', 'Escherichia infection', 'Escherichia test positive', 'Escherichia urinary tract infection', 'Glucose urine present', 'Haematocrit decreased', 'Haemoglobin decreased', 'Hyponatraemia', 'Hypotension', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Lethargy', 'Neck pain', 'Pain', 'Pyrexia', 'Rhabdomyolysis', 'Septic encephalopathy', 'Staphylococcal infection', 'Staphylococcal sepsis', 'Staphylococcus test positive', 'Tachycardia', 'Urinary retention', 'Urinary tract infection', 'Urine analysis abnormal', 'White blood cell count increased', 'White blood cells urine negative']",1,PFIZER\BIONTECH,IM 995477,NY,42.0,F,"lock jaw, bilateral upper extremity itching, nausea, vomiting, possible bell palsy, arm/leg weakness",Not Reported,,Not Reported,Yes,,Not Reported,U,01/23/2021,01/30/2021,7.0,PVT,,,,"12/26 covid, moderna, rashes on both arms, vomiting, low grade fever","strawberries, morphine, naproxen, shellfish","['Limb discomfort', 'Muscular weakness', 'Nausea', 'Pruritus', 'Trismus', 'Vomiting']",2,MODERNA,IM 995485,VA,61.0,F,"Covid positive 1/29/21. 2/1/21, hypoxia, tachycardia. Admitted to hospital 2/1/21. Diagnoses: UTI, Covid-19 infection, hypoxia, sepsis.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/21/2021,01/29/2021,8.0,OTH,Rx Number Drug Name Strength Form Fills Remaining NDC Last Filled R28974788 ACETAMINOPHEN 325MG TABLET 2 TABS (650MG) BY MOUTH EVERY 4 HOURS AS NEEDED FOR PAIN / FEVER - MAX ACETAMINOPHEN 3-4GM DAILY - CHECK DAILY TOTAL 325MG TAB,"Hospitalized for UTI/sepsis December 28-30, 2020.","0 Profound intellectual disability. S/P total abdominal hysterectomy, right salpingo-oopharectomy, left partial oophorectomy, S/P left ovarian fibroma and uterine fibroids. Hx of pica. S/P left 2nd metacarpal fracture 2002. Hx of recurrent pneumonia. History of sinus tachycardia of unknown etiology. 1 Inability to monitor own healthcare needs 2 Inability to maintain optimal nutritional status 3 GERD with small hiatal hernia 4 Epilepsy- generalized convulsions 5 Allergic rhinitis and nasal dryness 6 Constipation with redundant dilated colon 7 Cataract left eye. Hx of retinal choroiditis left eye 8 Tremor- intermittent and at rest. 9 Cervical stenosis with degenerative joint disease of lumbar and cervical spines, disc protrusion at C5-C6 11 Cough/variant asthma- typically in setting of URI. Behavioral component to cough 12 Halitosis 33 Insomnia 34 Osteopenia on the left femoral neck 35 Mycotic nails 36 Unspecified Anxiety Disorder 37 0.8cm mass retroareolar area right breast. 38 Autism spectrum disorder. 39 Impaired glucose tolerance.",,NKDA,"['COVID-19 pneumonia', 'Computerised tomogram thorax', 'Computerised tomogram thorax abnormal', 'Condition aggravated', 'Full blood count', 'Hypoxia', 'Metabolic function test', 'SARS-CoV-2 test positive', 'Sepsis', 'Tachycardia', 'Urinary tract infection']",1,MODERNA,IM 995519,AZ,84.0,F,"Two days, 1/29 ,after shot, vomiting and fatigue, emergency room visit on 1/31 , additional ER visit on 2/01. Continual slight stomach upset but general fatigue and weakness still prevalent.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/29/2021,2.0,PVT,none,none,COPD -asthma,,"penicillin, sulfa","['Abdominal discomfort', 'Asthenia', 'Chest X-ray', 'Computerised tomogram head', 'Differential white blood cell count', 'Electrocardiogram', 'Fatigue', 'Full blood count', 'Metabolic function test', 'SARS-CoV-2 test', 'Urine analysis', 'Vomiting']",1,PFIZER\BIONTECH,IM 995520,ND,89.0,M,"1-12-21 Resident is complaining of heart pain. Resident blood pressure is 228/105. 1-22-21 Dx UTI 1-13-21 His nurse called MD at approximately 0645, reported to him that it was reported to this nurse that resident has not slept in 2 days and night, has an increased blood pressure, reports severe pain in lower back, and appears to be uncomfortable Resident is able to verbalize his pain and where it is at, but is unable to explain the quality of the pain or give a number on the 0/10 pain scale.",Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/22/2021,15.0,SEN,"Clopidogrel 75 mg daily, Depakote 125 mg Twice daily, Imdur, Lexapro20 mg daily, lisinopril 10 mg daily, metoprolol succinate 25 mg daily, proscar 5mg daily, seroquel 50 mg daily, seroquel XR 150 mg daily, trazadone 50 mg daily, flomax 0.4",No illness at time of vaccination or one month prior.,"Atherosclerotic heart disease, Hypertension, Borderline personality disorder, Dysthymic, Chronic ischemic heart",,NKA,"['Angina pectoris', 'Back pain', 'Blood pH increased', 'Blood pressure increased', 'Confusional state', 'Discomfort', 'Insomnia', 'Pollakiuria', 'Urine analysis', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 995522,VA,65.0,F,"Upper respiratory symptoms with cough and mild fever. Anorexia. 1/28/21, initially returned from ER but sent back to ER 1/29/21, for persistent symptoms and poor oral intake.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/19/2021,01/29/2021,10.0,OTH,R29001026 ACETAMINOPHEN 325MG TABLET 2 TABS (650MG) BY MOUTH EVERY 4 HOURS AS NEEDED FOR PAIN OR FEVER - MAX ACETAMINOPHEN 3-4GM DAILY - CHECK DAILY TOTAL 325MG TABLET 10 00904671980 1/20/2021 R28410813 BLISTEX LIP OINTMENT APPLY TO LI,,,,"Phenytoin, Bactrim.","['Blood lactic acid', 'COVID-19', 'Chest X-ray', 'Cough', 'Decreased appetite', 'Electrocardiogram', 'Full blood count', 'Hypophagia', 'Lactic acidosis', 'Metabolic function test', 'Pyrexia', 'Respiratory symptom', 'SARS-CoV-2 test positive', 'Urinary tract infection', 'Urine analysis']",1,MODERNA,IM 995527,DE,46.0,M,"Thrombosis, right hepatic vein, Hepatic Abscess ( 10 cm)",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/20/2021,01/22/2021,2.0,MIL,Unknown,Unknown,Unknown,,Unknown,"['Computerised tomogram', 'Hepatic vein thrombosis', 'Liver abscess']",UNK,MODERNA, 995547,KS,,F,Fever of 99.0 for 24 hours after vaccination. took tylenol throughout the night. Did not seek medical treatment,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,PVT,"Prenatal vitamins, Vitamin B6 and Unisom as needed, Omega 3 fatty acid and Vitamin D3, Pepcid AC",no,no,,"No food allergies but allergic to Bactrim, sulfa, penicillin and azithromycin",['Pyrexia'],2,MODERNA,SYR 995559,,,F,"Her pulse was 146 and 45 minutes later, her pulse was 136/her pulse was 105/6 hours later her pulse continued to come down; Her pulse was 146 and 45 minutes later, her pulse was 136/her pulse was 105/6 hours later her pulse continued to come down; Throwing PVCs like crazy; Hard to take a deep breathe; This is a spontaneous report from a contactable Nurse (patient). A (Age: 64, Unit: Unknown) female patient received BNT162B2 first dose on 14Jan2021 at single dose for covid-19 immunization. Medical history included thyroidectomy and concomitant medications were not reported. Patient wanted to know if tachycardia had been reported as an adverse reaction following administration of the Covid vaccine 12 hours later. Caller stated that she received her first dose of the Covid vaccine last Thursday (14Jan2021). Twelve and a half hours after administration of the vaccine (14Jan2021), her pulse was 146 and 45 minutes later, her pulse was 136. Caller's husband took her to the ER and in the 5.5 hours she was there, she received IV saline and had been ""throwing PVCs like crazy."" She was released from the ER around 3 a.m 15Jan2021., in which her pulse was 105 and she was throwing PVCs periodically at this time. 6 hours later her pulse continued to come down. Caller stated that it is still hard to take a deep breathe, but her oxygen saturations have been fine, ranging in the 70s to 105, then back down to 80s. Caller stated that she has no comorbidities and has only had a thyroidectomy in which her TSH is normal on 14Jan2021. She has no cardiac problems, in which a cardiologist did an EKG and found it to be normal on 14Jan2021. The cardiologist advises her to ""absolutely take the second dose."" Caller stated that she is scheduled for a stress test and echo on the 28Jan2021. Caller is also scheduled to receive the second dose on 04Feb2021. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of tachycardia, premature ventricular contractions and abnormal pulse due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Thyroidectomy,,,"['Blood thyroid stimulating hormone normal', 'Dyspnoea', 'Electrocardiogram normal', 'Ventricular extrasystoles']",1,PFIZER\BIONTECH, 995560,SC,31.0,F,"Immune Thrombocytopenia Purpura; the only feature that was new to her was the vaccination provided 23Dec2020 and 09Jan2021 to complete her COVID series; This is a spontaneous report from a contactable physician. A 31-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunization. Medical history included eczema, no known allergies. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular on 23Dec2020 at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was seen in the ED for petechiae and ecchymoses on 15Jan2021. She had not taken any recent medication or had any illness previous to this event. The only feature that was new to her was the vaccination provided 23Dec2020 and 09Jan2021 to complete her COVID series. Lab assessment showed platelet count decreased to 22,000 cells per cubic microliter (normal over 140,000). She had no other findings to describe cause of her decreased platelet count by lab or clinical exam. Provided a diagnosis of immune thrombocytopenia purpura, in the ED setting, she started pulse dexamethasone 40 mg/day for four consecutive days with a follow blood count showing resolution on day 4 of her treatment with a platelet count of 230,000 cells per cubic microliter. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received Steroids as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of event immune thrombocytopenia purpura was recovered in Jan2021. Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of immune thrombocytopenia purpura due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including platelet count at baseline and during therapy with subject drug, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Eczema,,,"['Ecchymosis', 'Immune thrombocytopenia', 'Petechiae', 'Platelet count decreased']",2,PFIZER\BIONTECH, 995568,MA,58.0,F,"The injection site got red and swollen, very itchy lasting 48 hrs.",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/26/2020,01/02/2021,7.0,PVT,"Vits, Omeprazole",No,No,Flu vaccine(pain at injection site),No,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 995578,CA,79.0,F,"Vaccination date: 1/30/21. Nausea, vomiting & abdominal pain started 1/31/21, day after vaccination. Presented to emergency room 2/1/21. found to be hypoxic 85% (pt. had not been on supplemental 02). chest x-ray showed some patchy opacities likely COVID-19 induced fibrosis (per MD progress notes)",Not Reported,,Not Reported,Yes,,Not Reported,U,01/30/2021,01/31/2021,1.0,UNK,"insulin, allopurinol, amiodarone, Eliquis, diltiazem,, Neurontin, metoprolol, Keppra, protonix, ambien, senokot,","COVID illness requiring hospitalization 12/22/21 - 1/1/21, acute kidney failure, acute hypoxic respiratory failure secondary to COVID 19 pneumonia","CHF, CKD stage III, HTN, A-fib",,,"['Abdominal pain', 'Chest X-ray abnormal', 'Condition aggravated', 'Fibrosis', 'Hypoxia', 'Lung opacity', 'Nausea', 'Vomiting']",1,MODERNA, 995580,TX,39.0,M,Resident developed uncontrolled coughing and vomiting. sent to ER resident tested positive for COVID-19 however resident originally tested positive on 12/04/20,Not Reported,,Not Reported,Yes,,Not Reported,N,01/29/2021,02/01/2021,3.0,SEN,"famotidine, flonase, multivitamin, lactobacillus, desmopressin, guaifenesin, os-cal +d3, Baclofen, loratadine, Pheno liquid 1.4%. acetaminophen, Brimonidine, spironolactone, polyethylene glycol, diclofenac gel, Metoprolol tartrate, lantopro",Covid-19,"unspecified convulsions, diabetes, hypopituitarism, hypotension, Gastrostomy, dysphagia, anemia, glaucoma",,Latex,"['COVID-19', 'Cough', 'SARS-CoV-2 test positive', 'Vomiting']",2,PFIZER\BIONTECH,IM 995591,AL,95.0,F,patient developed A-fib after receiving Moderna Vaccine,Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/14/2021,02/02/2021,19.0,PVT,,,"ARTERIAL THROMBOSIS, SUBARACHNOID INTRACRANIAL HEMORRHAGE, GOUT",,,['Atrial fibrillation'],1,MODERNA,SYR 995619,NJ,29.0,F,"On 21st -22nd morning started having severe vomiting x 8-10 episodes with nausea, chills, and headache. On Sunday 1/24/21-1/26 started with severe epigastric sharp upper abdominal pain, never had before. Was getting worse. Went to virtua ER on 1/26/21 evening, had ct scan with contrast showing fluid around galbladder and ultrasound showed wall thickening to 11mm, positive Murphy?s sign and fluid around galbladder. I was admitted overnight and surgeon had recommended removal due to ejection fraction of 12% from hida scan done on 1/27. Endoscopy was done also and was negative. Cholecysitis was the presumed diagnosis, with normal LFTS. I left and returned to ER where they did repeat ct scan showing distention , pain continued. Admitted for 1 night. Pain was improving on Friday 1/29 , when I was discharged after repeated ultrasound showed resolved fluid. No history of any previous GI issues and no gallstones were noted on any imaging. I consume a healthy diet. Now having continued epigastric pain but improving.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/19/2021,01/22/2021,3.0,PVT,Zyrtec 10mg,N/A otherwise healthy,"History of femoral neck fracture 2015, ORIF hip surgery 2015 to repair",,,"['Abdominal distension', 'Abdominal pain upper', 'Chills', 'Cholecystitis', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram abnormal', 'Endoscopy normal', 'Gallbladder enlargement', 'Headache', 'Hepatobiliary scan', 'Hepatobiliary scan abnormal', 'Laboratory test', 'Liver function test normal', 'Nausea', 'Pain', 'Ultrasound abdomen abnormal', 'Vomiting']",2,MODERNA,IM 995629,NY,32.0,F,"Pt. with known allergic type reaction after first dose of vaccine, discussed getting the 2nd vaccine by intensivist and pulmonologist and was advised to go ahead and get second vaccine. 1st vaccine Reaction: Itchiness of entire body, fatigue, tongue ""felt funny,"" stomach cramping. She was premedicated with Prednisone 40 mg po, Benadryl 25 mg po, Pepcid 20 mg morning of vaccine. Pt. was administered vaccine at 12:15 am and at 12:40, she started to have tongue and throat itching, swelling, voice change, H/A and abd. pain. Medical first response was called and Dr. (Anesthesia) and FNP was present on-site at 12:41 Epi 0.3 mg sq was given. Additional 50 mg IM of Benadryl was also administered. Pt. was transported to ED via wheelchair and found to have angioedema and dx of anaphylaxis. Pt. was administered Benadryl IV, Pepcid IV, Solu-Medrol IV, Epi IV was administered in the ED due to persistent angioedema. She was discharge home same day at 16:03 and asked to f/u with PCP in1-3 days. 2/2/21- Still on prednisone, pepcid and Zrytec. Tongue still feels itchy and a little swollen, but overall feeling well.",Not Reported,,Yes,Not Reported,,Not Reported,,01/29/2021,01/29/2021,0.0,PVT,"Prednisone 40 mg po, Benadryl 25 mg PO, Pepcid 20 mg, Symbicort and Qvar. PRN ""Triptan"" for migraines","1/14- hypokalemia, asthma exacerbation,","Asthma, Migraine, Heart murmur Mitral and Pulmonary, IBS",,None.,"['Abdominal pain', 'Anaphylactic reaction', 'Angioedema', 'Dysphonia', 'Headache', 'Pharyngeal swelling', 'Swelling', 'Swollen tongue', 'Throat irritation', 'Tongue pruritus']",2,MODERNA,IM 995641,ND,89.0,M,"Resident was hospitalized for confusion, and hypotension and increased weakness; resident proceeded to have a NSTEMI and died on 5th day in hospital on 1/31/2021.",Yes,01/31/2021,Not Reported,Yes,5.0,Not Reported,N,01/06/2021,01/31/2021,25.0,SEN,"Lipitor 40mg po QD, Baclofen 10mg po BID, Tylenol ES 500mg po BID, Senna-S 50/8.6mg po BID, Vitamin D3 5000 IU po QD, Multivitamin tablet po QD, Garlic Oil 1000mg po QD, Lasix 40mg po QD, Aspirin EC 81mg po QD, Metformin 500mg po QD, Lisino",No active illnesses at time of vaccination or 1 month prior to vaccination; was diagnosed with UTI between vaccination and date of death.,"Malignant neoplasm of prostate, Hypothyroidism, Type 2 Diabetes Mellitus, Hyperlipidemia, Multiple Sclerosis, Neuropathy, Essential primary hypertension, Atrial Fibrillation, Heart Failure, Peripheral Vascular Disease, Constipation, Weakness, Dry mouth, Personal history of Urinary Tract Infections",,NKA,"['Acute myocardial infarction', 'Asthenia', 'Blood test', 'Computerised tomogram', 'Condition aggravated', 'Confusional state', 'Death', 'Hypotension', 'Urinary tract infection']",1,PFIZER\BIONTECH,IM 995649,OH,79.0,F,Cardiac arrest; Patient transported by EMS to hospital 11:00pm on 01/29/2021. Patient received vaccine on 01/25/2021. Patient expired 01/30/2021 within the hour into the new day after midnight on 01/30/2021. Patient was feeling well prior to and any chronic health conditions were well controlled. Sudden cardiac arrest 4 days after receiving the vaccine. Details given by patients husband/POA.,Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/29/2021,4.0,SEN,,none,"Thyroid disorder, HTN, Peripheral neuropathy, anxiety",,"Augmentin, sulfa","['Cardiac arrest', 'Death']",1,PFIZER\BIONTECH,IM 995650,CT,50.0,F,"Around 6 hrs after vaccine felt fatigue. I also exp tenderness at injection site and 9 days shortness of breath with diarrhea/mild headache.I went to urgent care for Covid, PCR test (results negative). I had symptoms approximately 10 days before shortness of breath resolved.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/21/2020,12/30/2020,9.0,PVT,Multivitamins,No,No,Yellow fever-Mild tenderness injection site(also exp these symptoms with annual Flu vaccine),No,"['Diarrhoea', 'Dyspnoea', 'Fatigue', 'Headache', 'Injection site pain', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 995662,CA,44.0,M,"at 30 a.m. patient got sweaty and passed out. As a result he injured himself. Hospital said all labs were good, full work up and no foreseen reason for passing out. Said possible reaction to vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/01/2021,01/27/2021,26.0,OTH,"aripirazole, atorvastin,vit d3 ,d�v�lproex,latuda,metformin, setriline. sodium chloride",,"pre diabetic ,",,,"['Cardiac function test normal', 'Computerised tomogram normal', 'Hyperhidrosis', 'Injury', 'Laboratory test normal', 'Loss of consciousness', 'Magnetic resonance imaging normal']",1,MODERNA,SYR 995722,MD,70.0,M,"per the EUA, cases of COVID 19 that result in hospitalization or death are to be reported: This patient received Moderna 1/7 and on 1/16 they were COVID positive. Patient was admitted for pneumonia Length of stay 15 days",Not Reported,,Not Reported,Yes,15.0,Not Reported,,01/07/2021,01/16/2021,9.0,PVT,,,,,,"['COVID-19', 'Pneumonia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 995724,AZ,37.0,M,A couple days later I began experiencing a slight sore arm. Several days later I had a constant headache. Around January 25 I began experiencing non-stop chest pain and on January 27 woke up with severe pain in my arm. I went to the emergency room and was diagnosed with an NSTEMI.,Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/19/2021,01/27/2021,8.0,PUB,"acetaminophen, ibuprofen",none,High cholesterol,,none,"['Acute myocardial infarction', 'Blood test', 'Catheterisation cardiac', 'Chest pain', 'Echocardiogram', 'Electrocardiogram', 'Headache', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 995789,TX,65.0,M,"The patient received the vaccine on the afternoon of Thursday, 1/28/21. He was observed for at least 30 minutes following administration of the vaccine with no reactions noted. He was found dead in his car on Sunday, 1/31/21. It is unknown if the vaccine contributed to his death.",Yes,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/31/2021,3.0,OTH,Unknown,Unknown,Diabetes Heart Condition,,Unknown,['Death'],1,MODERNA,IM 995825,NC,92.0,F,"Client unexpectedly collapsed and passed away on 1/13/21 from suspected sudden cardiac death. Prior to her death, she was in skilled care for rehabilitation following hospitalization from 12/21-12/31/20 for an acute lower GI bleed. Her hospitalization and skilled care stay were complicated by delirium and she was being treated for delirium with olanzapine (Zyprexa) at time of death.",Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/13/2021,7.0,SEN,Calcium carbonate Cholecalciferol Ezetimibe Insulin (Lantus) Levothyroxine Olanzapine melatonin pantoprazole Senokot-S Sitagliptin Preservision AREDS,Acute lower GI bleed (diverticular bleed) occurred in 12/21/2020 and hospitalization from 12/21-12/31/20 complicated by delirium,Type 2 DM HLD Macular degeneration Hearing loss HTN Hypothyroidism Osteopenia,,"Statins, ace inhibitors, hydrocodone, metformin, codeine, metoprolol XL","['Delirium', 'Gastrointestinal haemorrhage', 'Sudden cardiac death', 'Syncope']",1,MODERNA,IM 995859,AR,55.0,F,"Shaking , burning in arm, leg chest face, rapid heart rate",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,Travoprost,None,High eye pressures,,"Penicillin, sulfa, zoloft,","['Burning sensation', 'Chest pain', 'Computerised tomogram head', 'Electrocardiogram', 'Heart rate increased', 'Laboratory test', 'Magnetic resonance imaging', 'Magnetic resonance imaging neck', 'Tremor']",2,PFIZER\BIONTECH,IM 995864,OH,59.0,F,Developed Shingles,Not Reported,,Not Reported,Not Reported,,Yes,N,01/18/2021,01/19/2021,1.0,PVT,"Vitamin C, B-12, Multivitami n,Calcium, Vitamin D supplements. Amlodipine, Norvasc,metoprolol, Cellcept,Prednisone, plaquenil,Atacand. Calcium","Lupus SLE, High Blood Pressure,Fibromylagia, Osteoporasis, Srogen Syndrome","SLE Lupus,Fibromyalgia, Osteoporosis, High Blood Pressure",,"Dilaudid, Bactrim",['Herpes zoster'],1,MODERNA,IM 995916,OH,83.0,M,"Patient received vaccine at clinic, waited the 15 minutes and was released. Passenger in car, wife driving shortly after departing from clinic - wife state he passed out in the car for approximately 10 seconds, no loss of bowel, or bladder control. Had some UE jerking movements, he was quite awake and alert once he woke up and did not exhibit and post-ictal symptoms. Synocpal episode at 1300 was in Vtac per Boston Scientific Reading.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/01/2021,02/01/2021,0.0,PVT,"Pantoprazole 40 mg daily; Coreg 12.5 mg bid; venlafaxine ER 75 mg daily, metformin 500 mg BID; Potassium chloride 10 mEq daily, Lantus 10 units in AM, 50 units QPM; glipizide 10 mg BID; Tamsulosin 0.4 mg daily, prental MVI daily; bumetanid",No documentation,"Arthritis, HTN, CRT-D, NICM, CAD cystic Thyroid Nodule, DMII, Hyperlipdemia, OSA, COVID, Afib s/p ablation, HFrEF s/p CRT-D boston EF 2% NYHA III Stage C",,NKDA,"['Cardiac telemetry', 'Dyskinesia', 'Electrocardiogram abnormal', 'Loss of consciousness', 'Syncope', 'Ventricular tachycardia']",2,MODERNA,IM 995949,WI,39.0,F,Miscarriage reported,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,02/01/2021,10.0,PHM,Unknown,,,,None noted,['Abortion spontaneous'],1,PFIZER\BIONTECH,IM 995953,CA,40.0,M,Acute left sensorineural hearing loss with tinnitus. Significant hearing impairment noted on audiometric evaluation. Symptoms began a day after receiving the second dose of the moderna vacccine.,Not Reported,,Not Reported,Not Reported,,Yes,N,01/30/2021,02/01/2021,2.0,PVT,None,None,None,,None,"['Audiogram', 'Deafness neurosensory', 'Hypoacusis', 'Tinnitus']",UNK,MODERNA,IM 995977,VA,51.0,M,"Lethargy/altered level of consciousness lead to hospital admission. Multiple interventions during hospitalization. Final hospital diagnoses: Acute respiratory failure with hypercapnia, acute pansinusitis.",Yes,01/27/2021,Not Reported,Yes,2.0,Not Reported,N,01/19/2021,01/25/2021,6.0,OTH,"Latest medication list available to us 12/18/19, due to record being deleted after death: CORN STARCH POWDER RED AREA BETWEEN 3RD AND 4TH FINGER RIGHT HAND - APPLY CORN STARCH FOUR TIMES DAILY - FACILITY TO SUPPLY ACYCLOVIR 200MG CAPSULE 1",,"0 Profound intellectual disability (F73) secondary to Angelman's Syndrome with microcephaly (Q38.2); Macroglossia (750.15), rumination (307.53) and aerophagia, S|P aspiration pneumonia 9/98(507.0), history of coagulopathy (286.9); finger clubbing probably secondary to chronic pulmonary disorder; surgery 12/70 for undescended testes; Nissen fundoplication w/pyloroplasty 5/2/88; H/o Acne Vulgaris (L70.0) 31 Inability to monitor own health care needs. Frequent urinary tract infections. 39 Gastroesophageal reflux (K21.9) 56 Megacolon and tendency to fecal impaction (K59.3, K56.4) 57 Hand mouthing secondary to Angelman's syndrome 59 Chronic recurrent herpes simplex (B00.9) 60 Recurrent cyanosis (R23.0), secondary to mucus plugging 61 Maintain optimal nutritional status altered by severe dysphagia (R13.10) 62 Osteoporosis probably secondary to immobility (M81.0) 63 Needs to maintain optimal musculoskeletal status 64 Optic atrophy(H47.20)secondary to Angelman?s syndrome, myopia(H52.10) 77 Prone to dehydration 83 Hiatal hernia (K44.9) 84 Peripheral vascular disease, poor circulation of bilateral ankles and feet. ?? Frequent UTIs. Small bilateral renal stones.",,"Aspirin, NSAIDs.","['Acute respiratory failure', 'Altered state of consciousness', 'Hypercapnia', 'Imaging procedure', 'Laboratory test', 'Lethargy', 'SARS-CoV-2 test negative', 'Sinusitis']",UNK,MODERNA,IM 995978,NY,54.0,F,"Patient with a subjective complaint after first covid vaccine where patient felt a hot flushed feeling across chest and throat and face of which patient did not self medicate nor seek treatment. Patient was given Benadryl 25mg IM pre vaccination at 12:39pm, vaccine given at 1:00pm and while being observed by vaccination team, patient become diaphoretic, pale, ""throat tightness"" that was appreciated to be swollen, and difficulty swallowing at 1:11pm at which point Epinephrine 0.3mg was given IM to L anterior thigh. Patient's vitals were the following: BP 148/86, HR 124 bpm. After epinephrine, patient's throat swelling and breathing much improved, and able to swallow. Patient was then transported to ED in wheelchair via wheelchair. Patient was given Dexamethasone 10mg IV, Pepcid 20mg IV, and Benadryl 25mg IV. Only complaint that patient had during ED visit was palpitations of which HR did regulate to 86 bpm, BP 149/70. Patient was discharged on 1/29/2021 at around 4:50pm as patient was fully asymptomatic and able to ambulate on own. Sent home with prednisone 40mg po daily x 7 days, pepcid and benadryl otc. Advised to f/u with PCP in 1-2 days and suggested possible allergy testing.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PVT,Benadryl 25mg IM,"1/11/2021 Chest Pain r/o CAD 1/21/2021 GERD, Constipation","GERD, OSA, HLD, r/o CAD",,NKDA at the time,"['Dysphagia', 'Hot flush', 'Hyperhidrosis', 'Pallor', 'Palpitations', 'Pharyngeal swelling', 'Throat tightness']",2,MODERNA,IM 995995,VA,51.0,M,"Fever. Hypoxia. SOB. Hospital admission diagnoses: Aspiration, right lower lobe pneumonia, hyponatremia.",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,01/21/2021,01/27/2021,6.0,OTH,ACETAMINOPHEN OUTER UD 650MG/20.3ML SOLUTION 20.3 ML (650MG = ONE DOSE CUP) VIA GAST-TUBE EVERY 6 HOURS AS NEEDED FOR PAIN OR FEVER - MAX ACETAMINOPHEN 3-4GM DAILY - CHECK DAILY TOTAL 650MG/20.3ML SOLUTION 7/31/2020 ACETAMINOPHEN OUTER,Upper respiratory congestion 1/11/2021.,"0 Profound intellectual disability; Autism spectrum disorder History of Apgar Score of 7, 8, and 9 at Birth, X-Linked Mental Retardation. History of fracture of base of 3rd distal phalanx of left hand ; Hx of Tuft fx left great toe no further treatment indicated; history of emergency appendectomy (5/23/86); Exophthalmos; glaucoma maternal and paternal side of family. Anoxia secondary to choking episode (2/5/13), History of hypertension. H/O foot drop; undetermined etiology, Trach stoma site. Unspecified neurocognitive disorder 1 Inability to monitor own health care needs 2 Epilepsy. Lennox-Gestault. 33 Obsessive/compulsive disorder 39 Dysphagia with recurrent aspiration and g-tube placement and inability to maintain optimal nutritional status 50 Idiopathic SIADH (syndrome of inappropriate ADH secretion) causing chronic hyponatremia. 53 Osteoporosis of Lumbar spine, left femoral neck and mean total proximal left femur. 55 Hyperopia of the right eye (OD), nystagmus; myopia ; glaucoma suspect 65 Frequent nose bleeds 66 Allergic rhinitis 67 Constipation 68 Lactose intolerance 69 Recurrent conjunctivitis 79 Lichen simplex chronicus with irritant/contact dermatitis and recurrent secondary infection. 80 Flat feet (pes planus) and hyperpronation 82 At risk for dehydration 84 Recurrent aspiration pneumonia with chronic scarring and atelectasis left lung base. 85 Insomnia, agitation, restlessness, repetitive vocalizations, severe Bruxism and aggression ? probably related to mania. 88 Intermittent hypoglycemia 94 Vitamin D deficiency 95 Increase and maintain weight within IBW range 97 Internal hemorrhoids with occasional bleeding. 98 S/P surgical repair subcapital fracture of the right femur. 99 Tardive dyskinesia secondary to psychotropic medication. 100 Macrocytic anemia probably due to medications. 103 Gastritis.",,"Listed in record as: Anafranil, Benadryl, Haldol, Lamictal, penicillin, Risperdal, Zithromax, Keppra, Tegretol, polymyxin-B sulfate.","['Aspiration', 'Blood culture', 'Blood lactic acid', 'Blood test', 'Chest X-ray', 'Dyspnoea', 'Full blood count', 'Hyponatraemia', 'Hypoxia', 'Metabolic function test', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test negative', 'SARS-CoV-2 test positive', 'Urine analysis']",UNK,MODERNA,IM 996004,OH,46.0,F,"The vaccine was administered incorrectly. The IM injection was given too high on the left arm. The injection immediately caused significant pain in the left shoulder which worsened throughout the day and into the following day. The significant pain in the left shoulder has persisted and is accompanied by decreased AROM, decreased strength, and sleep disruption. Treated with Ibuprofen 800mg q8h and ice with minimal benefit. Saw PCP on 01/29/2021 who recommended continuation of same and ordered a PT referral. Was unable to work for 3 days due to this complication.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/25/2021,01/25/2021,0.0,PUB,Sumatriptan 100mg daily PRN Fluoxetine 20mg daily,None,Migraines Behcet's Syndrome,,NKDA,"['Arthralgia', 'Asthenia', 'Immediate post-injection reaction', 'Impaired work ability', 'Injection site pain', 'Joint range of motion decreased', 'Muscular weakness', 'Product administered at inappropriate site', 'Sleep disorder']",2,MODERNA,IM 996053,AZ,42.0,F,After first vaccine had LR rash after second vaccine had Bell?s palsy possible stroke,Not Reported,,Yes,Not Reported,,Not Reported,U,01/01/2021,01/26/2021,25.0,OTH,Water pill,None,None,,Pcn,"['Facial paralysis', 'Rash']",UNK,PFIZER\BIONTECH, 996055,WA,80.0,F,"Patient came back from cardiology appointment (at 2pm) unresponsive. It was reported that she had vomited while at the appointment. She was confused when she could be aroused, stating that she does not have a name.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/02/2021,02/02/2021,0.0,SEN,,,,,,"['Blood glucose increased', 'Confusional state', 'Unresponsive to stimuli', 'Vomiting']",2,PFIZER\BIONTECH,IM 996058,NY,97.0,F,"My mother fainted on the night she was vaccinated, early in the morning. She had gone to the kitchen to get a heating pad and felt faint while standing She didn't make it to a chair, but fell and broke her hip. While this could have been due to another health problem, my mother had never had a fall or a near-fall. it is concerning that very old adults are not warned to have someone with them after receiving the vaccine (for instance, overnight), I realize that the vaccine has not been studied specifically in geriatric populations, but it is realistic to assume that there are substantial numbers of very old people living on their own, particularly in cities where there is no need to drive, and where food and other necessities can be delivered. There should be a warning to people that they should not be alone after receiving the vaccine.",Not Reported,,Yes,Yes,5.0,Yes,N,01/31/2021,02/01/2021,1.0,PUB,diuretic (high bp medication); liquid morphine for arthritis pain; CIPRO antibiotic for cystitis,urinary infection (recent--one week);,osteoarthritis; osteoporosis; acid reflux; joint pain,,none,"['Dizziness', 'Fall', 'Hip fracture', 'Syncope']",UNK,MODERNA,SYR 996086,CA,55.0,M,"Pt received vaccine on 7 jan. 2021 Twelve days later, on 19 January 2021, Pt developed symptoms of COVID (cough, sore throat, fever, myalgias), on 20 Jan, pt admitted to hospital for worsening symptoms. Pt tested positive for COVID 19. Pt admitted to ICU where pt had complicated hospital course to include ARDS secondary to COVID pneumonia, nonSTEMI, with biventricular heart failure, on multiple pressor, rhabdomyolysis with acute kidney injury, requiring CRRT. Pt was in hospital for 10 days; he passed away on 31 Jan 2021.",Yes,01/31/2021,Not Reported,Yes,10.0,Not Reported,N,01/07/2021,01/19/2021,12.0,MIL,unknown,,"h.o HTN, elevated BMI",,unknown,"['Acute kidney injury', 'Acute myocardial infarction', 'Acute respiratory distress syndrome', 'COVID-19 pneumonia', 'Cardiac failure acute', 'Cough', 'Death', 'Intensive care', 'Myalgia', 'Oropharyngeal pain', 'Pyrexia', 'Renal replacement therapy', 'Rhabdomyolysis', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 996105,CA,95.0,F,"patient received vaccine on Jan 23, 2021 passed away on Jan 24, she was already on hospice, so unclear if due to vaccine or other issues. Was at her baseline before and after vaccine per facility, had b'fast and passed away at noon on Jan 24",Yes,01/24/2021,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/24/2021,1.0,SEN,"Levothyroxine, senna, multivitamins, aspirin and possible hospice medications","Dementia, hypothyroidism, coronary artery disease, patient was already on hospice, so unclear if vaccine related . Pt was at her baseline until she passed away","Dementia, hypothyroidism, coronary artery disease, HTN, multiple other medical issues",,"Egg, co-trimoxazole, Sulfa",['Death'],UNK,PFIZER\BIONTECH,IM 996110,TN,57.0,F,"Fever, and muscle aches, weakness, arthritis was terrible. Hurt worse after shot for a couple of days",Not Reported,,Not Reported,Not Reported,,Yes,U,01/04/2021,01/04/2021,0.0,OTH,"Amlodipine, Methocarbamol, Meloxicam, Muiltivitamin, Zinc, Elderberry, Vitamin B12,",Had Covid in December was 34 days out from it when I got first shot.,Arthritis,,None,"['Arthritis', 'Asthenia', 'Condition aggravated', 'Myalgia', 'Pain', 'Pyrexia']",1,MODERNA,SYR 996156,MN,58.0,F,"Client came to nursing station about 2pm to report she ""was not feeling well"". Nurses took vital signs, then referred her to the vaccination clinic that was onsite. She was observed by vaccination team for a period of time. She reported shoulder pain radiating into shoulder blade in arm vaccine was received. Vaccination team offered ice pack to her, observed for a period of time, and released back to work. About 10pm that evening, she sent a text to another coworker that her pain was ""off the charts"" and that she had pain covering her whole left side of her body. She did not come to work in the morning and did not contact work. Well being check was performed at approximately 9am on 2/2/2021 and she was found dead in her home. 911 was immediately called and authorities took over the scene.",Yes,02/02/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,SEN,Unknown,Unknown,Hypertension,,Unknown,"['Arthralgia', 'Death', 'Impaired work ability', 'Injection site pain', 'Malaise', 'Pain']",2,MODERNA,IM 996158,AZ,85.0,F,"Seizure like activity, nausea",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/27/2021,01/27/2021,0.0,SEN,Clopidogrel Sertraline Lorazepam Acetaminophen Nitroglycerin,COVID19,"Essential Hypertension, Anxiety Disorder, AHD, Angina, Mild Cognitive Impairment, Depression",,"Bupropion, Crab, Strawberries","['Laboratory test', 'Magnetic resonance imaging', 'Nausea', 'Scan brain', 'Seizure like phenomena']",1,MODERNA,SYR 996259,TX,72.0,M,Unknown. Was informed that the patient went to E/R on 1/25/21 (6 days after receiving vaccine. Died 1/29/21 ( 10 days after receiving vaccine).,Yes,01/29/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/25/2021,6.0,PVT,"Fluoxetine HCL, 20 mg, Magnesium Oxide, 400 mg, Atrovastatin/Calcium, 10 mg, Omprazole, 20 mg, Lisinoprilm 2.5.mg, Lyrica, 200mg, Metoprolol Tartrate, 25 mg , Potassium Chloride 20 meq,","COPD, Chronic Hypoxemic respiratory failure, Chronic bronchitis, Atrial Fibrillation, OSA on CPAP","COPD, Chronic Hypoxemic respiratory failure, Chronic bronchitis, Atrial Fibrillation,",,"Wellbutrin, Niaspan","['Death', 'SARS-CoV-2 test negative']",1,MODERNA,IM 996269,MO,69.0,F,I give the girl in front of me the Covid vaccine way high on her arm. I told MA do not give my shot that high up. She said in a snide voice it?s still the deltoid and she shot my bursa. The evening of the shot I started having severe arm pain and nausea. The next morning I had right scapula rib pain it was hard to breathe my arm hurt very bad I can hardly lift it I went to work. When I got to work I couldn?t function I was so nauseated with the pain I went home that day and I?ve missed three days total from that event of wrong injection site. The pain has gotten worse I can?t lift my arm left right upper down without pain and it?s going into my neck and down to my elbow now I went to the occupational medical doctor. I told him what happened and he said she gave me the shot am I supraspinatus Bursa and I have an injury to my bursa. I came back for a second visit the next week and he said I have bursitis from that now I can?t raise and use my arm that well at all and I have severe pain 24 seven still and he sent me to a physical therapist starting today 2 to 21. It has gotten worse and my shoulder has locked up three times. I still have ongoing pain 24 seven and I want to report a complaint against the girl who gave my shot I thought she was an LPN but she is a MA. We both work at healthcare clinic. I am a 26 year RN and she did not listen to me and she stuck me anyway against my will.,Not Reported,,Not Reported,Not Reported,,Yes,N,12/30/2020,12/30/2020,0.0,PVT,Levothyroxine,None,None,,Levoquin,"['Arthralgia', 'Bursa injury', 'Bursitis', 'Dyspnoea', 'Impaired work ability', 'Joint range of motion decreased', 'Mobility decreased', 'Musculoskeletal chest pain', 'Nausea', 'Neck pain', 'Pain', 'Pain in extremity', 'Product administered at inappropriate site']",UNK,PFIZER\BIONTECH,SYR 996291,AK,86.0,F,Death,Yes,01/29/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/29/2021,22.0,SEN,"Haloperidol, Morphine, Lorazepam","HTN, Cerebral Infarction, Anxiety, Hx breast neoplasm","HTN, Cerebral Infarction, Anxiety, Hx breast neoplasm",,"Codeine, Tramadol, Valsartan, Keflex, Penicillins",['Death'],2,PFIZER\BIONTECH,IM 996372,CA,60.0,M,"On 1/14/2021 ( about 14 days from dose # 1) Tachycardia of unknown origin, 120 BPM for 6 hours, Called Cardiologist and was seen @ MD next business day, and given EKG and Bystolic 10 MG to ""add"" to daily regimin IF it returned. It retuned to normal after 6 hours, and then occurred again 1 week later...for 6 hours. I took Bystolic, and about 8 hours later it returned to baseline (about 62/min. on Sun 1/24/2021, I woke up to bloody diarrhea x several episodes...this continued until Wed 27th, at which time my son (a 4th year graduating MD student) drove me to hospital and I was seen in ER room by MD. I was admitted, and had emergency surgery 1/27/2021 straight from Er Room. I had life saving surgery the next day to stop a lower GI bleed (of unknown origin). I was discharged 3 days later, and I am awaiting more testes, appts, etc.... I have lost time, money, and work from this near death experience... and the tachycardia still needs to be followed up on . I am EXTREMELY upset by these events, as I almost died....was hospitalized, incurred a lot of expense, used up all my sick pay and personal days, and out-of -pocket to my healthcare insurer.",Not Reported,,Yes,Yes,3.0,Not Reported,N,12/31/2020,01/14/2021,14.0,PHM,"Avalide 150/12 tab, Cosyntex 150 sub-Q every 10 days,, Toprol XL 50mg, Flomax 0.4mg, Claritin 10mg, Norco 10/325 prn, soma 350 prn, Celebrex 200 daily, Vit C 1000mg QD, Vit E 5000K QD, Phyto-Multi vit from Metagenics QD,",none,"Ankylosing Spondylitis, Mild Hypertension, Hyperlipidemia , Lower Back fusion (with hardware 1999) ,",,"Thimerasol (Mercuric perservative) , Lanolin, Lipitor","['Blood test', 'Colonoscopy', 'Computerised tomogram abdomen', 'Diarrhoea haemorrhagic', 'Electrocardiogram', 'Gastrointestinal haemorrhage', 'Impaired work ability', 'Near death experience', 'Surgery', 'Tachycardia']",1,MODERNA, 996409,GA,71.0,F,"PATEINT FELT FINE ON THE HOME FROM PHARMACY, STARTED FILLING ILL (NOT QUITE HERSELF) BEFORE BED. SHE AWAKENED AT 5:45 AM. FELT AS IF SHE WAS GOING TO FAINT. SAT DOWN AND PASSED OUT AND HAD A SEIZURE. SLID OUT OF THE CHAIR AND URINATED ON HERSELF AND THE FLOOR. WAS TRANSPORTED BY AMBULANCE TO HOSPITAL.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/16/2021,01/17/2021,1.0,PHM,"NONE, MULTIVITAMIN, CALCIUM, D3, VITAMIN E, ZINC AND CLARITIN",NONE,NONE,,NONE,"['Chest X-ray', 'Computerised tomogram head', 'Culture urine', 'Differential white blood cell count', 'Dizziness', 'Electrocardiogram', 'Feeling abnormal', 'Full blood count', 'Loss of consciousness', 'Malaise', 'Metabolic function test', 'Seizure', 'Syncope', 'Troponin I', 'Urinary incontinence', 'Urine analysis']",1,MODERNA,IM 996423,WV,81.0,M,Patient had a CVA and passed away suddenly 1/10/21,Yes,01/10/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/10/2021,6.0,PUB,,,Wife reported patient had diabetes and high blood pressure.,,,"['Cerebrovascular accident', 'Sudden death']",1,MODERNA,SYR 996425,PA,62.0,F,fever and facial swelling,Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/28/2021,01/29/2021,1.0,SEN,"Amaantadine, Clonazepam, Depakote, Lithium, Olanzapine, Omeprazole, Oxybutynin, Prazosin",,"Schizophrenia, Major Depressive d/o, Anemia, Acute respiratory failure with hypoxia, HTN, Morbid obesity, Diabetes",,"codeine, Keflex, penicillins","['Pyrexia', 'Swelling face']",2,PFIZER\BIONTECH,IM 996468,NY,76.0,F,"76 yo female with PMHx of CAD s/p CABG 2016, abdominal aortic aneurym, HTN, HLD, Asthma, Diverticulosis, Osteopenia. Presenting to the ED after having Pre-syncope. She reported that today morning she felt nauseated with episode of vomiting, burping and abdominal discomfort after having her lunch meal, headed out to receive her vaccine, she felt well till 10 minutes after the vaccine where a nurse noticed she is pale and less responsive, BP was measured back then and was ~70 ?, the patient reported that she was sitting when that happened, she felt lightheaded, sweating, blurry vision, nauseated. But denies any chest pain, sob, palpitation, weakness or numbness. She was out of balance and feeling weak till she came to the ED where she felt better after IV fluids.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/20/2021,01/20/2021,0.0,PVT,Aspirin 81 Atorvastatin 80 Losartan 50 HCTZ 25 mg Omega 3 Vitamin D Vitamin C Tramadol 50,None,"ASHD (arteriosclerotic heart disease) Asthma � Dequervain's tenosynovitis, left � Diverticulitis � Diverticulosis � Dyslipidemia � Osteopenia R hip S/P laparoscopic cholecystectomy",,"Heparin Sodium, Porcine - Angioedema Codeine - Nausea and Vomiting Simvastatin - Nausea and Vomiting Lisinopril - Swelling","['Abdominal discomfort', 'Asthenia', 'Balance disorder', 'Dizziness', 'Hyperhidrosis', 'Hyporesponsive to stimuli', 'Nausea', 'Pallor', 'Presyncope', 'Vision blurred', 'Vomiting']",1,PFIZER\BIONTECH,IM 996550,IL,43.0,F,"Terrible headache, chills to the point I?m shaking, upset stomach, body aches, fever 100.2, runny nose, sore throat",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,PUB,Metformin,No,Followed by oncologist because of stump tumor. Diabetes.,,None,"['Abdominal discomfort', 'Chills', 'Headache', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'Rhinorrhoea', 'Tremor']",1,MODERNA,SYR 1000852,,41.0,F,Dizziness & NauseaVomiting Narrative: discharge diagnosis of acute labrinathis requiring walker to ambulate. Having falls,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/27/2021,01/28/2021,1.0,OTH,,,,,,"['Dizziness', 'Fall', 'Labyrinthitis', 'Nausea', 'Vomiting', 'Walking aid user']",2,MODERNA,IM 1000854,,73.0,M,"Narrative: Pt became unresponsive after receiving 2nd dose of covid vaccine, leading to ED visit. Pt also completed hemodialysis prior to receiving vaccine. Pt reported feeling tired, lightheaded prior to syncope. On arrival to ED, BP was 80/60 mmHg, given lactated ringers and BP improved. Pt admitted for high risk possible syncopal episode.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/20/2021,01/20/2021,0.0,OTH,,,,,,"['Dizziness', 'Fatigue', 'Syncope', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 1000858,,61.0,M,"Angina Narrative: Pt presented to the ED with persistent chest pain and shortness of breath for 6 days after receiving 2nd dose of covid vaccine. Symptoms began morning after receiving vaccine. Negative work up, however pt is high risk of cardiac events. Given ASA and nitro for ongoing chest pain that is possibly cardiac in nature. Pt admitted.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/15/2021,01/15/2021,0.0,OTH,,,,,,"['Chest pain', 'Dyspnoea']",2,PFIZER\BIONTECH,IM 996566,UT,44.0,F,"Rash at injection site 8 days after shot. (""Covid arm"") Rash is slowly going away 3 days after it appeared.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/30/2021,8.0,SCH,None,None,None,,None,['Injection site rash'],1,MODERNA,SYR 996567,OR,65.0,F,"8 days following vaccine, injection site became painful again. Day 10 it became itchy, red, and hot. Feels bruised. (Initially on days 1-3 only had arm soreness)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/31/2021,8.0,OTH,Synthroid Vitamin D Estradiol external cream,None,None,"Super flu shot. Age 65. Received early October in left arm. Severe swelling, redness, fever, chills, fatigue.",Sulpha antibiotic Endocin (anti inflammatory),"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 996569,WA,45.0,F,"Flu like symptoms: started getting week and tired. Went to bed about 11pm and could barely get up in the morning at 4:30 am. Headache, low grade fever of 99.7, achy all over, a bit of nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,SEN,"Vitamin B12, Vitamin D Magnesium",None,None,,,"['Asthenia', 'Fatigue', 'Headache', 'Influenza like illness', 'Nausea', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 996570,NJ,56.0,F,"for the 2 dose again my blood pressure rose to 168/109 and the back of my throat began to itch , I was then taken to the emergency room for treatment for my adverse reaction, while in the emergency room my upper body began to itch my right began to hurt and got a slight headache, I was discharge after receiving treatment. While at home I have chills and was tired.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,PVT,"metformin 500mg, metropolo 100mg, amlodipine 5mg , trucility once a week",Diabetes High blood Pressure,high blood pressure diabetes,"12/31/20 age 55 my blood pressure raised, and I felt tired.","All Nuts, All Berriers, All seafood. Lactose intolerant","['Adverse reaction', 'Chills', 'Fatigue', 'Headache', 'Hypertension', 'Pain', 'Pruritus', 'Throat irritation']",2,MODERNA,SYR 996571,MD,50.0,F,"Within 6 hours, expected R arm pain and beginnings of a headache. On 1/28/21, moderate headache continued but was fatigued/lethargic and had muscle pain and body aches. On 1/29/21, headache decreased and felt refreshed. On 1/30/21, had moderate headache, slight body aches, and was sleepy. 1/31/21, slept most of the day, was irritable and some nasal congestion noted along with the headache. 2/1/21, sweated throughout the night, no fever but was either hot or cold. Irritable with brain fog as well. Facial flushing, neck pain, swollen lymph nodes in pelvic and bilateral submandibular areas. Throat does not look red or patchy but some post nasal drip involved. Tongue has geographical patches which started about 1 year ago and is random. Had unilateral lymphedema and geo tongue both 1 year ago for reference. CT results, reactive.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/28/2021,1.0,PUB,Novolog insulin via pump,None,Type 1 Diabetes Neuropathy HTN Sjogrens Syndrome,,"Reglan, Bees, latex sensitive","['Disturbance in attention', 'Fatigue', 'Flushing', 'Headache', 'Hyperhidrosis', 'Irritability', 'Lethargy', 'Lymphadenopathy', 'Myalgia', 'Nasal congestion', 'Neck pain', 'Pain in extremity', 'Somnolence']",2,MODERNA,IM 996572,CA,21.0,U,"Inflamation, pain on touch, remaining hard spot of some tissue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/23/2021,1.0,PHM,Weed,,,,Some fruits and vegetables. Mainly leafy greens,"['Induration', 'Inflammation']",1,MODERNA,SYR 996573,CA,65.0,F,"nausea, diarrhea, dizziness, aches & pains all over body, feeling weird, tired, can't get up, all lasting 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,SCH,apple cider,,"kidney disease, eye disease, asthmatic",,,"['Diarrhoea', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Nausea', 'Pain']",UNK,PFIZER\BIONTECH, 996574,CA,66.0,M,"There was no adverse event involved. only a series of moderate side effects that went on for about 8 days. My father received his first dose on 1/21 after 3 days on Sunday evening of 1/24 he started chills and fever till 1/31. He experienced persistent fever as high as 104.7 even 105 at one point followed by fatigue and body-ache. He no longer had any fever on 2/1, just mostly fatigue and not having much energy and also couple episodes of coughs. As of 2/2 he is doing much better looks to be fully recovering. I wanted to know if you would advise if he should get his second shot as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/24/2021,3.0,OTH,"fluoxetine 20 MG, Vitamin D3 3000 IU",No known illness prior to the vaccine,No Major health condition,,No previous known Allergies,"['Chills', 'Cough', 'Fatigue', 'Pain', 'Pyrexia']",1,MODERNA,SYR 996575,FL,40.0,F,"Severe itching, redness, sores on back, arms, torsal, upperlegs, buttocks.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/23/2021,2.0,PVT,,,,,,"['Erythema', 'Pain', 'Pruritus']",UNK,MODERNA,IM 996576,IN,54.0,M,"Mild body aches, dizziness, low-grade fever (99.4), headache. Body aches started about 20 hours after dose, followed by dizziness and fever. Headache lingered the longest. All resolved approximately 30 hours after dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/31/2021,02/01/2021,1.0,PVT,"famotidine, cetirizine, hydrochlorothiazide, multivit, vit C",,"hypertension, obesity, GERD, irritable bowel syndrome","Shingrix, severe flu-like symptoms",Kelfex,"['Dizziness', 'Headache', 'Pain', 'Pyrexia']",2,MODERNA,IM 996577,TX,25.0,F,"Fever lasting 8 hours straight, resolved for 4 hours, returned for 2, chills with fever, severe muscle aches for 24 hours, headache for 24 hours, N/V with headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/29/2021,1.0,PVT,"Propanolol 60mg ER daily, Prenatal Vitamin daily, Sprintec daily, Docusate Sodium 100mg every other day.",None,None,"Flu Vaccine 9/2020 age 25, nausea/vertigo/vomiting x4 days.",Pecans,"['Chills', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 996578,SC,19.0,M,"Body aches, chills, shaking, headache, neck pain, fever, insomnia, rust colored spots on palms and fingers and finger tips",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/02/2021,1.0,PHM,Lorazepam 1mg Lamotrigine 100mg Fluoxetine 40mg Amlodipine 10mg Ibuprofen 800mg Baby aspirin,None,Anxiety Hypertension,,Codeine,"['Chills', 'Headache', 'Insomnia', 'Neck pain', 'Pain', 'Pyrexia', 'Tremor']",UNK,UNKNOWN MANUFACTURER, 996579,ID,35.0,F,Rash on left arm at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,02/02/2021,7.0,WRK,"Vitamin C, Vitamin D",,,,N/a,['Injection site rash'],1,MODERNA,SYR 996580,TX,29.0,M,"Pain at injection site - sudden and more painful compared to that of dose 1. Other adverse events that happened with second dose that did not happen with 1st dose: - Insomnia on 1/28/21 night up to 1/29/21 early morning, needed melatonin to help with falling asleep. - Grogginess/lightheadedness on 1/29/21 morning, some mild headache. Proceeded to take 2 Tylenol 650 mg tabs. - Headache, dizziness, and fatigue worsening during 1/29/21 throughout the day. Severe headache/dizziness, especially if moving head quickly, on 1/29/21 evening - prompting to take 2 Advil 200 mg tabs. - The headache and injection site pain were lessened significantly, but still there on 1/30/21. All other symptoms resolved. - All symptoms resolved by 2/1/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,PVT,Tums,H pylori infection,"Seborrheic dermatitis, hyperlipidemia",,None,"['Condition aggravated', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Insomnia', 'Somnolence']",2,MODERNA,IM 996581,,21.0,M,"c/o subjective fever with dizziness and sweating. Temperature, tmax 100.0F (A) at home. Pt received 2nd dose of COVID Vaccine at 0930 02Feb2021. Patient is a 21 year old male who presents to ED with subjective fever, dizziness, sweating and papitation 8 hours after receiving his second Moderna vaccine. He denies any chest pain, no shortness of breath. He doe shave some nausea, but it able to drink fluids well. No other significant PMH.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/02/2021,0.0,MIL,UNK,NO,,,NKDA,"['Dizziness', 'Hyperhidrosis', 'Nausea', 'Palpitations', 'Pyrexia']",2,MODERNA,IM 996582,CA,30.0,F,"After taking the vaccine around 9:45 am, 1/27, I started feeling mild pain so took ibuprofen. -after an hour or less, I started getting itchy, burning hives all over my face and scalp. - hives disappeared by the end of the day. - next morning there was bad headache, almost passed out, threw up. -entire body pain for atleast 3 days - have been getting hives on face on and off till this date 2/2.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,PVT,I took ibuprofen after getting the vaccine because I started feeling mild pain. I was at work and I didn't have any other pain reliever so borrowed from my coworker.,acid reflux,none,,Most NSAIDS triggers rosacea including ibuprofen.,"['Burning sensation', 'Dizziness', 'Headache', 'Pain', 'Pruritus', 'Urticaria', 'Vomiting']",2,MODERNA,SYR 996591,CA,85.0,F,"patient received vaccine on Jan 23, 2021. developed weakness on Jan 25, 2021. Sent to ED on Jan 27, 2021 with hypoxia requiring 6 L O2, low Bp, declining mental status. Per family request transitioned to hospice and passed away on Jan 30, 2021",Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/25/2021,2.0,SEN,"citalopram, Wellbutrin, docusate, Seroquel, acetaminophen, senna, may have received hospice medications","Dementia, depression, arthritis, IBS, atherosclerosis of aorta, hyperlipidemia, osteoporosis","Dementia, depression, arthritis, IBS, atherosclerosis of aorta, hyperlipidemia, osteoporosis",,Codeine Penicillin simvastatin,"['Asthenia', 'Death', 'Hypotension', 'Hypoxia', 'Mental status changes']",UNK,PFIZER\BIONTECH,IM 996726,MS,,U,"tested positive for COVID-19; tested positive for COVID-19; patient already has missed the second dose on schedule; This is a spontaneous report from a contactable healthcare professional. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 29Dec2020 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient tested positive for COVID-19 on unspecified date. The patient already has missed the second dose on schedule. Outcome of the events was unknown. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 996727,LA,32.0,F,"Pt +covid test 14Jan2021; Pt +covid test 14Jan2021; Tachycardia; Facial flushing; Fatigue; arm pain and swelling; arm pain and swelling; This is a spontaneous report from a contactable Other HCP. A 32-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 12Jan2021 at single dose for COVID-19 immunisation, administered at hospital. Relevant medical history included attention deficit hyperactivity disorder (ADD), hypothyroidism and anxiety. Past drug history included allergy to cefprozil (CEFZIL). Relevant concomitant medications included bupropion hydrochloride (WELLBUTRIN XL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and levothyroxine sodium (SYNTHROID). On 12Jan2021, the patient had tachycardia, facial flushing, fatigue, arm pain and swelling. The events required a physician office visit. Therapeutic measures taken as result of the events included levocetirizine dihydrochloride (XYZAL) and diphenhydramine hydrochloride (BENADRYL). On 14Jan2021, the patient underwent a COVID-19 virus test (nasal swab) which resulted positive. The outcome of the events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 12Jan2021, and COVID-19 test positive on 14Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/12/2021,0.0,PVT,WELLBUTRIN XL; ADDERALL; SYNTHROID,,Medical History/Concurrent Conditions: ADD; Anxiety; Hypothyroidism,,,"['COVID-19', 'Fatigue', 'Flushing', 'Pain in extremity', 'Peripheral swelling', 'SARS-CoV-2 test positive', 'Tachycardia']",1,PFIZER\BIONTECH, 996731,FL,79.0,F,"urine issues/kept going to the bathroom to urinate; upset stomach; diarrhea; felt like she was going to faint, pass out at any second; dizziness; Had a funny taste in her mouth; felt very weird, strange; This is a spontaneous report from a contactable consumer (patient). This consumer reported same events for two patients (one is patient self). This is the first of two reports. This 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration to right arm on 13Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included allergies to Sulfas, Penicilins, and Avelox, Sulfa or Penicillin allergies since she was a child and had the Avelox allergies about 15-16 years ago. None concomitant medications. Patient did not receive any other vaccines that day or 4 weeks prior. Did get the original Shingles vaccine about 3 years ago and then they came out with the new one and she got the first dose of that and believes she had a reaction to that one, thinks it was a rash. Also had the flu shot and she usually gets sick with it, but didn't with this last one. Thinks her body is just delicate. No vaccines administered on same date. Patient had the Pfizer BioNTech vaccine on 13Jan2021 15:00 and she was fine. She had a reaction the following day (on 14Jan2021). At 11am the next day she got very dizzy and felt like she was going to faint, pass out at any second. Used cold compresses and drank water and took deep breaths, but she didn't pass out. She had a funny taste in her mouth. Then from that time until about 7pm she had urine issues and kept going to the bathroom to urinate and had diarrhea and upset stomach. Patient felt like she was out of her body, felt very weird, strange. Doctor stated she maybe had a reaction to the vaccine and recommended for her to take Tylenol. She didn't take it until right before going to bed. She was able to sleep on 14th night. Woke up the next morning and was fine. She didn't see any of these reactions listed and that happened. Patient explained to a friend of the reactions and the friend mentions that she also had a friend who had the vaccine and had the same exact reactions, everything. Everything improved and stopped the next morning she was fine, on the 15th. No Emergency Room or Physician Office visit. The events outcome was recovered on 15Jan2021. It was just a span of time and she has to assume that it was the vaccine since she has never had that before. Patient does not know if she should blame the vaccine because she also has a lot of allergies to a lot of antibiotics and does not know what caused her reactions.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021065869 Same reporter/ vaccine/ AEs, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/14/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Penicillin allergy; Sulfonamide allergy,,,"['Abdominal discomfort', 'Diarrhoea', 'Dizziness', 'Dysgeusia', 'Feeling abnormal', 'Pollakiuria']",1,PFIZER\BIONTECH, 996732,AL,25.0,F,"Diagnosed with Bell's Palsy six days after receiving the vaccine; This is a spontaneous report from a contactable other HCP (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in the right arm on 06Jan2021 14:30 at first single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. On 12Jan2021, the patient was diagnosed with bell's palsy six days after receiving the vaccine. COVID was tested post vaccination: Nasal Swab: negative on 13Jan2021. AE resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Event treatment included oral steroids. Outcome of the event was not recovered.; Sender's Comments: Based on the temporal relationship, the association between the event Bell's palsy with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/12/2021,6.0,PVT,,,,,,"['Facial paralysis', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,OT 996733,FL,46.0,F,"sensory neuro bilateral hearing loss worse on one side; tinnitus; This is a spontaneous report from a contactable physician (patient). A 46-years-old female patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular into right arm on 05Jan2021 at 0.3 mL, single for covid-19 immunization. Time the vaccination was reported as 10:00-10:30. Medical history included food and environmental allergies. The patient had a history of autoimmune antibodies to thyroid but with normal thyroid numbers. No medication was needed, but autoimmune antibodies was found in the past. She had a propensity for autoimmune disease, it was just not active. She was diagnosed the first time she found auto antibodies 12 years before 19Jan2021 (2009) and checks her thyroid yearly and they had been normal. She still had antibodies, but thyroid hormone levels are normal without intervention. The patient's concomitant medications included Vitamin C and Vitamin D. Historical vaccine included Pneumovax 30 days before getting the COVID vaccine (06Dec2020, 46-years-old). Her pneumonia titers were low. Historical vaccine also included flu shot, she felt sick but like everyone else, she did not consider that abnormal. She thought most people felt kind of down and it did not have long term effects. It did not require any doctor visits. She did not have a rash or anaphylaxis. The patient was a physician and well versed in terms of symptoms. By evening of 05Jan2021, she developed tinnitus, which she had never had and has been there ever since. She was on day 13 post vaccine and still having bilaterally, every day and it never went away. She had a physician visit on 12Jan2021 and hearing test performed that day. They did find sensory neuro bilateral hearing loss worse on one side, her test confirmed bilateral hearing loss at 11:00 on 12Jan2021. It was mild so far in the high frequency ranges. So, they gave option to start 14 day course of high dose steroids with steroid injections into the ear, because in some cases of acute hearing loss, it can curb or reduce it. She decided to do that. Now she was going to be on steroids. She would be temporarily immunosuppressed. She did not know if that will affect the vaccine. She had not decided if she will get second shot. It is due next week, but she was a little nervous. She was considering delaying the booster a couple months out to see if more information develops. She provided her weight as between 175 to 180lb. Right now, the hearing loss was mild and it won't be that bad, but normally, it was permanent, which would be disabling hearing loss. She was going 20Jan2021, for the steroid injection in the ear canal. That would be the first injection. She was taking oral steroids now. They would see if this limits the progression. The events outcome was not recovered.; Sender's Comments: The possible causality between the reported tinnitus/sensory neuro bilateral hearing loss and the administration of COVID-19 vaccine, BNT162B2, cannot be fully denied based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/05/2021,01/05/2021,0.0,PVT,VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS,,Medical History/Concurrent Conditions: Autoimmune thyroid disorder (propensity for autoimmune disease/ found auto antibodies); Environmental allergy; Food allergy,,,"['Acoustic stimulation tests abnormal', 'Deafness bilateral', 'Deafness neurosensory', 'Hearing disability', 'Immunosuppression', 'Inappropriate schedule of product administration', 'Nervousness', 'Tinnitus']",1,PFIZER\BIONTECH,OT 996734,MA,86.0,F,"Congestive cough; Weakness; didn't have an appetite; legs felt stiff, or almost frozen; Severe muscle weakness/extreme weakness was only in her mother's lower body; tremendous fatigue/Tiredness; Couldn't walk; This is a spontaneous report from contactable consumers. An 86-year-old female patient (mother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 12Jan2021 10:15 at single dose for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) for years; COVID-19 Virus from 23Apr2020 to an unknown date, patient was not on a vent or in the ICU but did receive plasma as part of her COVID-19 Virus treatment; ongoing cough. Caller's grandmother had Multiple Sclerosis. There were no concomitant medications. The patient received her first Pfizer COVID-19 Vaccine dose, and had significant side effects. Patient weight was 175 lbs as provided by caller, who stated her mother recently moved into an independent living facility, and gained weight because the facility has a really good pastry chef. Patient height, reported her mother shrunk, and was 5'5-1/2"". Reported her mother couldn't walk after receiving the first dose. She said her mother was not able to walk the next morning, 13Jan2021. The caller stated she had to spend 3 days with her mother, after her mother received her first COVID-19 Vaccine dose on 12Jan2021. Reported she thought initially what her mother was experiencing was either neurological or muscular. She said it was like her mother's brain wanted her to move, but her mother's legs wouldn't move. She said her mother needed to use a walker and have someone hold her from behind. She said now, at a week later, her mother still was not back to normal. She clarified her mother needed a walker to maneuver around, but didn't need someone holding her from behind. Reported she assumed her mother may have had tiredness, weakness, severe muscle weakness from receiving the first COVID-19 Vaccine dose. She clarified if her mother wasn't able to walk after receiving the first COVID-19 Vaccine dose, then what her mother had was the epitome of weakness, and the weakness was only in her mother's lower body. She said her mother had tremendous fatigue on days 2, 3, and 4 after receiving the first dose. She said her mother was able to function as of 19Jan2021, but her mother couldn't keep her eyes open during that time period. Reported her mother developed a congestive cough. She said her mother's cough was not continual, but persisting. She stated her mother said the cough was there before she had her first dose of the COVID-19 Vaccine. The caller stated she disagreed with her mother. She said her mother has COPD, but her mother was not a cougher. She said her mother's cough now, reminded her of the cough her mother had when her mother had the COVID-19 Virus in 2020. She clarified her mother was tested on 23Apr2020 for the COVID-19 Virus, and diagnosed positive for the virus on 24Apr2020. The caller said she was perplexed by her mother's cough, and her mother will be seeing her doctor this Thursday, 21Jan2021. She said she gave her mother some Robitussin for the cough. She said her mother's cough was not persistent, but the cough was still there. She said her mother's cough was not constant, but her mother's cough was congested. She said she didn't know when her mother's cough started. She said she thought giving her mother the Robitussin doses was kind of insignificant, because her mother did not have a constant cough, where she needed to take the Robitussin. She said her mother didn't even use half of a normal sized Robitussin bottle. Caller stated she did not have the Robitussin UPC, Lot, and Expiration Date. Reported her mother has an annual lung x-ray and MRI, clarifying she believed her mother had both within the past 3 months. Reported her mother was concerned about receiving the second COVID-19 Vaccine dose. She said she told her mother that it was better to get the second dose of the COVID-19 Vaccine than to get the COVID-19 Virus again. Reported her mother had asked her primary care doctor if she should get the COVID-19 Vaccine, and her doctor told her absolutely. She said her doctor told her she needed to take the COVID-19 Vaccine even if she had the plasma treatment with the COVID-19 Virus in Apr2020. Reported she planned to stay with her mother after her mother received the second COVID-19 Vaccine dose. She said she didn't anticipate her mother having a reaction after the first COVID-19 Vaccine dose because people said most reactions are happening after getting the second COVID-19 Vaccine dose. She said now people are reporting having reactions after the first COVID-19 Vaccine dose. Reported she thought her mother's side effect after having the COVID-19 Vaccine to be unusual, since most people say it feels like they have the flu, or they are tired, or they have a headache. Reported her mother not to be able to walk wasn't that her mother was not walking, but that her mother's foot wouldn't move. She said mother not walking was either neurologic or muscular, unless that is what extreme weakness is. She said she wondered if others have experienced what her mother has. She said if her mother was experiencing just extreme weakness, the extreme weakness was only in her mother's lower body, not in her upper body. She said her mother didn't have an appetite, but her mother was not too weak to put a spoon to her mouth. She said her mother couldn't move her legs, and her mother said her legs felt stiff, or almost frozen. She said if her mother had extreme weakness, and couldn't walk, what did that mean. She said if a person is really tired, the person can still move and get out of bed. She said her mother said she was really, really tired, and couldn't move. The caller said her mother said she couldn't move, and it took her mother 20 minutes to get her legs over the side of the bed. She said her mother not being able to move her legs could be extreme weakness, but observing her mother first hand, she said it looked like her mother not being able to move her legs was neurologic. She said her mother was strong in character and body, and her mother would do everything she could in her body to move, but it was like her mother's brain said ""go"", and her body said ""not now"". The outcome of the event Congestive cough was not recovered, of the other events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,UNK,,COPD (for years); Cough,Medical History/Concurrent Conditions: COVID-19 (was not on a vent or in the ICU did receive plasma as part of her COVID-19 Virus treatment),,,"['Asthenopia', 'Body height decreased', 'Cerebral disorder', 'Chest X-ray', 'Cough', 'Decreased appetite', 'Fatigue', 'Gait inability', 'Magnetic resonance imaging', 'Mobility decreased', 'Movement disorder', 'Muscular weakness', 'Musculoskeletal stiffness', 'Respiratory tract congestion', 'SARS-CoV-2 test positive', 'Somnolence', 'Walking aid user', 'Weight increased']",1,PFIZER\BIONTECH, 996735,NC,77.0,F,"Burning pain going down into the forearm on the same side vaccine given; This is a spontaneous report from a contactable pharmacist. A 77-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730) via an unspecified route of administration on 13Jan2021 12:30 single dose for covid-19 immunisation. Vaccine location was left arm. Patient did not receive any other vaccines that day and none 4 weeks prior. Medical history was none. There were no concomitant medications. The patient experienced burning pain going down into the forearm on the same side vaccine given on 17Jan2021. She has never experienced anything like this before having that vaccine. The event was reported as medically significant. The outcome was not recovered.; Sender's Comments: Based on the reasonable temporal association and considering he known safety profile of COVID-19 vaccine, BNT162B2, the Company considers there is a reasonable possibility that the reported ""burning pain going down into the forearm on the same side vaccine given"" is related to BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/17/2021,4.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Injection site pain', 'Pain']",UNK,PFIZER\BIONTECH, 996736,NJ,43.0,F,"felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twitching in hands; feel dizzy; A light rash covered my chest and arms; My heart rate and blood pressure were elevated; My heart rate and blood pressure were elevated; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 19:45 for covid-19 immunization, via Left arm in hospital. Medical history included arthritis from an unknown date and unknown if ongoing. She had no allergies to medications, food, or other products. Concomitant medication included probiotics (PROBIOTICS) and Multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 20 minutes following injection, the patient experienced felt numbness in mouth, felt numbness in mouth, it spread to arms and hands. She went to ER (Emergency room/department or urgent care) and started to feel dizzy and experienced muscle twitching in hands, a light rash covered her chest and arms, heart rate and blood pressure elevated, all on 19Jan2021 20:15 with outcome of recovering. She had no history of these symptoms and was in good health. The action taken in response to the event(s) for bnt162b2 was not applicable. She received Benadryl as a result of events.; Sender's Comments: The reported events were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/19/2021,1.0,PVT,PROBIOTICS,,Medical History/Concurrent Conditions: Arthritis,,,"['Blood pressure increased', 'Dizziness', 'Heart rate increased', 'Hypertension', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Muscle twitching', 'Rash']",1,PFIZER\BIONTECH, 996738,CA,54.0,F,"swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrrea; palpitation; Headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 14Jan2021 13:15 at single dose at left arm for covid-19 immunization. Medical history included known allergies: sulfas, codeine, latex. Concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. After 22 minutes received the vaccine on 14Jan2021: started swelling lips, numbness, rashes in the face and legs, high blood pressure, itching and headache, nauseas and diarrhea, until now still felling palpitation and headache. The adverse events resulted in emergency room/department or urgent care. Patient received treatment famotidine 20 mg, epinephrine for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Outcome of events palpitation and headache was not recovered, and outcome of other events was recovered with lasting effects in Jan2021. Information of lot/batch number has been requested.; Sender's Comments: The reported events swelling lips, numbness, rashes in the face and legs, high blood pressure, itching, nauseas and diarrhea, palpitation and headache, were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Latex allergy; Sulfonamide allergy,,,"['Diarrhoea', 'Headache', 'Hypertension', 'Hypoaesthesia', 'Lip swelling', 'Nausea', 'Palpitations', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH,OT 996739,CA,75.0,F,"Approximately 22 hours after vaccination had a seizure. Felt fine up until the seizure occurred. Never had a seizure in past. No other illness or symptoms. No fever or change in blood sugar.; This is a spontaneous report from a contactable Physician. A 75-year-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular on 18Jan2021 19:30 at single dose on left arm for COVID-19 immunization. Medical history included Stroke, diabetes, hypertension, anaphylaxis to bee stings. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included sitagliptin phosphate (JANUVIA), hydrochlorothiazide, telmisartan, rivaroxaban (XARELTO), gabapentin and baclofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had allergy to Morphine and experienced Hives. Approximately 22 hours after vaccination the patient had a seizure on 19Jan2021 17:15. She felt fine up until the seizure occurred. She never had a seizure in past. No other illness or symptoms. No fever or change in blood sugar. No treatment was received for the event. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was resolved. Information on the lot/Batch number has been requested.; Sender's Comments: Based on the time association and previously allergic reactions to bee stings and other drugs, the possible contribution of suspect BNT162B2 to the event seizure cannot be excluded in this elderly patient with multiple medical histories including stroke, diabetes and hypertension. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/19/2021,1.0,PVT,JANUVIA [SITAGLIPTIN PHOSPHATE]; HYDROCHLOROTHIAZIDE; TELMISARTAN; XARELTO; GABAPENTIN; BACLOFEN,,Medical History/Concurrent Conditions: Anaphylactic reaction (Bee sting (anaphylaxis)); Diabetes; Hypertension; Stroke,,,"['Blood glucose normal', 'Seizure']",1,PFIZER\BIONTECH,OT 996740,IL,37.0,F,"Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; This is a spontaneous report from a contactable pharmacist (patient). A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. Ek5730) at single dose, in the right arm, on 18Dec2020, at 03:30 PM, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. On 18Dec2020, at 07:00 PM, the patient developed Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness. Emergency Room Visit required. Hospitalization required (7 days admission in hospital). Treatment required: IVIG. The adverse events were assessed as serious (hospitalization and disability). Clinical outcome of the adverse events was recovering at time of this report. Post the vaccination, on 10Jan2021, the patient has been tested for COVID-19 and resulted negative. COVID-19 test type post vaccination: COVID-19 PCR test (Nasal Swab).; Sender's Comments: Based on the close temporal relationship, the association between the events Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,7.0,Yes,N,12/18/2020,12/18/2020,0.0,PVT,,,,,,"['Adverse event', 'Exposure during pregnancy', 'Facial paresis', 'Guillain-Barre syndrome', 'Immunoglobulin therapy', 'Muscular weakness', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 996741,IL,59.0,F,"Roscia-major flare occured in eyes/Continued to worsen over next 24 hours; severe itchiness; This is a spontaneous report from a contactable other Health Professional (patient). A 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 18Jan2021 08:15 at single dose in left arm for COVID-19 immunization. Medical history included non allergic rhinitis and vestibular migraines. The patient had not known allergic, but very sensitive to SE. Concomitant medications included ""sensimist"", naproxen sodium (ALEVE), progesterone, estradiol. The patient had no covid prior vaccination and did not had covid tested post vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 28Dec2020 08:45 at single dose in left arm for COVID-19 immunization. No other vaccine was received in four weeks. The patient experienced roscia-major flare occurred in eyes within 2 hours of second vaccine on 18Jan2021 09:00. Continued to worsen over next 24 hours. Necessitated a trip to eye dr. Have never had a flare this serious. In addition, severe itchiness day vaccine given. Took antihistamine (Allegra) second day which solved issue. The event was resulted in doctor or other healthcare professional office/clinic visit. The patient received Neomycin & Polymyxin B Sulfates & Dexamethasone Op as treatment. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/18/2021,0.0,PVT,ALEVE; PROGESTERONE; ESTRADIOL,,Medical History/Concurrent Conditions: Rhinitis; Vestibular migraine,,,"['Condition aggravated', 'Inappropriate schedule of product administration', 'Ocular rosacea', 'Pruritus']",2,PFIZER\BIONTECH, 996742,MI,49.0,F,"Severe headache; malaise; fatigue; syncope and collapse - orthostatic hypotension; Orthostatic hypotension; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 18Dec2020 at single dose at right arm for covid-19 immunization. Medical history included chronic fatigue, hypothyroidism, allergic rhinitis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took promethazine hydrochloride (PHENERGAN) and experienced allergies: phenergan. After 1st dose, patient had severe headache for five days, malaise, fatigue on 19Dec2020 09:45 PM, day 6 syncope and collapse - orthostatic hypotension in Dec2020. The adverse events resulted in emergency room/department or urgent care. Adverse events treatment included CT head, carotid doppler, echocardiogram, lab work. It was unknown if the patient was not diagnosed with COVID-19 prior to vaccination. Covid test type post vaccination included nasal swab on 24Dec2020: negative. Patient received second dose of bnt162b2 (lot number: el0142) on 08Jan2021 10:00 at single dose at left arm for covid-19 immunization. Outcome of events was recovered on unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of syncope, orthostatic hypotension and other events due to temporal relationship. However, the events may likely possibly represent concurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/01/2020,,PVT,,,Medical History/Concurrent Conditions: Allergic rhinitis; Chronic fatigue; Hypothyroidism,,,"['Computerised tomogram head', 'Condition aggravated', 'Echocardiogram', 'Fatigue', 'Headache', 'Laboratory test', 'Magnetic resonance imaging brain', 'Malaise', 'Orthostatic hypotension', 'SARS-CoV-2 test negative', 'Syncope', 'Ultrasound Doppler']",1,PFIZER\BIONTECH, 996743,NM,39.0,F,"some numbness on the right side of face; early Bell's Palsy; This is a spontaneous report from a contactable pharmacist. A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), intramuscular in the left arm on 17Dec2020 16:15 at a single dose for COVID-19 immunization. Medical history included allergic rhinitis, deviated nasal septum, Factor V Leiden, GERD (Gastroesophageal reflux disease), DVT (deep vein thrombosis), hypertension, neck pain on left side, rhinitis, and rhomboid muscle strain. Concomitant medication included fluoxetine, acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE), fluticasone nasal spray, hydrochlorothiazide, lisinopril, loratadine, meloxicam, omeprazole, oxycodone, and sodium chloride nasal spray. The patient had no other vaccines in four weeks before covid vaccine. The patient had no prior vaccination and she had not been tested post vaccination. The patient noticed some numbness on the right side of face after receiving the first dose of vaccine on an unknown date. She was concerned for early Bell's Palsy on 15Jan2021 at 09:00 AM. She will be treated with valganciclovir and prednisone. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events early Bell's Palsy and some numbness on the right side of face was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported ""concerned for early Bell's palsy"". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,01/15/2021,29.0,PVT,FLUOXETINE; EXCEDRIN MIGRAINE; FLUTICASONE; HYDROCHLOROTHIAZIDE; LISINOPRIL; LORATADINE; MELOXICAM; OMEPRAZOLE; OXYCODONE; SODIUM CHLORIDE,,Medical History/Concurrent Conditions: Allergic rhinitis; Deviated nasal septum; DVT (DVT (deep vein thrombosis)); Factor V Leiden thrombophilia (Factor V Leiden); GERD (GERD (gastroesophageal reflux disease)); Hypertension; Muscle strain; Neck pain; Rhinitis,,,"['Facial paralysis', 'Hypoaesthesia']",1,PFIZER\BIONTECH,OT 996744,OR,,F,"Huge swelling around my eyes and redness and tenderness; My left eye was swollen shut; Huge swelling around my eyes and redness and tenderness; My left eye was swollen shut; Huge swelling around my eyes and redness and tenderness; My left eye was swollen shut; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EL0140) via an unspecified route of administration on left arm on an unspecified date at a single dose for covid-19 immunization. The patient had a heart condition and a stroke. The patient concomitant medications were not reported. The patient stated that she had a when I had the shot on the 13th (not clarified) and end up going to urgent care on Friday. She had a huge swelling around her eyes and redness and tenderness and her left eye was swollen shut. She went to urgent care and got some antibiotics and some cream to put on it. The patient had not any lab test. However, she did have microblading done to her eyebrows, three days before she had the shot. The patient wanted to know if it was because she had the microblading done and then she got the shot. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Heart disorder; Stroke,,,"['Erythema', 'Eye swelling', 'Tenderness']",UNK,PFIZER\BIONTECH, 996745,,,M,"Knee joint swelled 3 times the size; Bruising that is not at the injection site that just came up; Looks yellow, like jaundiced; does not feel well; he looks a little pale; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EL3249, expiry date unknown) via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient, resident at the Nursing Home received the vaccine on 15Jan2021. On an unspecified date, his knee joint swelled 3 times the size. He has a bruising that is not at the injection site that just came up. Overall, he does not feel well and looks a little pale and jaundiced. He almost looks like yellow, like jaundiced. Should he go to the ER or should he wait? The reporter and the doctor did not know what to do. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,,,SEN,,,,,,"['Contusion', 'Jaundice', 'Joint swelling', 'Malaise', 'Pallor', 'Yellow skin']",UNK,PFIZER\BIONTECH, 996774,,,U,"Caller looking for information on second dose administration following a positive SARS-Cov-2; Caller looking for information on second dose administration following a positive SARS-Cov-2; This is a spontaneous report from a contactable Nurse. A patient of unspecified age and gender receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller looking for information on second dose administration following a positive SARS-COv-2 on an unspecified date. The outcome of the event was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 996777,CA,61.0,F,"She wore sunglasses in her house because the light bothered her eyes; Eyes felt dry; Loss of vision in right eye; Hole in her retina; Bad headache for 3 days; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported similar events for 2 patients. This is 1st of 2 report. A 61-year-old female consumer (patient) received 2nd dose of BNT162B2 (Covid Vaccine, lot number: EL1248) on 06Jan2021 at single dose in the right arm for COVID-19 immunisation. Medical history was not reported. Concomitant drug included Multivitamin, Vitamin C, Vitamin D Zinc all from Mar2020 and ongoing. Historical Vaccine was 1st dose of BNT162B2 (Batch/lot number: EK5730) on 18Dec2020 in the right arm. Patient got COVID vaccine and a few hours later or the next day she started getting a hole in her retina and started losing her site in right eye. she went to the doctor as she has a hole in her retina. Again, this may be totally unrelated but she wanted to call and get this reported. She is going to see a retinal specialist this afternoon. After she had her COVID vaccine she had a bad headache for 3 days. She wore sunglasses in her house because the light bothered her eyes. She noticed this on 16Jan2021 because she was looking at paperwork and her eyes felt dry. She blinked a few times and had opened one eye alone, and she noticed that her left eye was fine but the vision in her right was not. This could have been going on longer. She just never closes only one eye. When both are open, her vision is normal. She saw the eye doctor yesterday, and that is when they said she had a hole in her retina. They said she will have to have surgery to close the hole. She knows she is at the right age for this to spontaneously happen, but just in case it is related, she wanted to report it. Outcome of the event Loss of vision in right eye was Not Recovered, for headache was recovered, for other events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046804 same reporter, AE and drug, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/01/2021,,UNK,VITAMIN C [ASCORBIC ACID]; VITAMIN D [ERGOCALCIFEROL]; ZINC,,,,,"['Abnormal sensation in eye', 'Blindness unilateral', 'Eye disorder', 'Headache', 'Photophobia', 'Retinal tear']",2,PFIZER\BIONTECH, 996796,NJ,44.0,M,"bell palsy; Headache; rash; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 44-years-old male patient received the first dose of BNT162B2 via an unspecified route of administration on 15Jan2021 15:30 at single dose in deltoid left for COVID-19 immunisation. Medical history included ongoing hypertension, Lactose intolerance, and lipids were a bit elevated on 14Jan2021. Family history included mother has diabetes and hypertension. The patient was allergic to Olives. There was no other vaccine in four weeks. Concomitant medication included ongoing lisinopril daily for blood pressure, ongoing colecalciferol (VITAMIN D) weekly, ongoing duloxetine to help with the blood pressure control, and ongoing Multivitamins daily. On Friday 15Jan2021 night around 11:00 PM he started experiencing headaches and rash. On Sunday night (17Jan2021) he experienced the bell palsy/Facial Paralysis and went to the ER. For bell palsy, the patient first had a shot of steroid, then was given oral Methylprednisonole and oral Famcyclovir. Treatment also received for headache and rash. He is still taking Still taking Methyl-prednisolone and the Famcyclovir and he will end these medications tomorrow. The patient had blood work on 14Jan2021 with normal result, lipids were a bit elevated. Events outcome was not recovered. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,UNK,LISINOPRIL; VITAMIN D [COLECALCIFEROL]; DULOXETINE,Hypertension,Medical History/Concurrent Conditions: Diabetes; Fruit allergy; Hypertension (Mother has Diabetes and hypertension); Lactose intolerance; Lipids decreased,,,"['Blood test', 'Facial paralysis', 'Headache', 'Lipids increased', 'Rash']",1,PFIZER\BIONTECH, 996904,,,F,"Bleeding of the veins, temples; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bleeding of the veins, temples. The patient's medical history was not provided. No relevant concomitant medications were reported. On Unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On unknown date, the patient experienced bleeding of the veins, temples. Treatment for the event was not provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the event, bleeding of the veins, temples was unknown.; Reporter's Comments: This case concerns a female patient of unknown age, who experienced a serious unexpected event of Haemorrhage. The event occurred on unknown date after first dose of mRNA-1273, lot # unknown. Treatment information is not provided. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Giant cell arteritis', 'Haemorrhage', 'Vein rupture']",1,MODERNA,OT 996905,,,F,"7-8 drops of vaccine fell down arm when vaccine was given; A spontaneous report was received from a consumer concerning her 75-year old, mother who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, 7-8 drops of vaccine fell down the arm when the vaccine was given. The patient's medical history was not provided. Concomitant medications were Levothyroxine sodium, Atorvastatin calcium and Acetylsalicylic acid. On 20 Jan 2021, the patient received their first dose of two planned doses of mRNA-1273 (Lot Number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient received the mRNA-1273 vaccine and 7-8 drops of vaccine fell down the arm when the vaccine was given. As per the reporter, the vaccinating nurse stated that she believed that less than half of the dose was actually given. No treatment for the event was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, 7-8 drops of vaccine fell down the arm when the vaccine was given was considered Resolved on 20 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273. There were no reported adverse events associated with this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/20/2021,0.0,UNK,ASPIRIN (E.C.); THYROXINE; STATIN [ATORVASTATIN CALCIUM],,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Incorrect dose administered'],1,MODERNA,OT 996907,TN,,F,"Felt like she was having a seizure, her head kept moving back and forth; Tremendous amount of mucous in her naval cavity; Didn't feel good; Got really hot; A spontaneous report was received from a consumer who was a 76-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced really hot, didn't feel good, felt like she was having a seizure, head kept moving back and forth, and tremendous amount of mucus from her nasal cavity. The patient's medical history included vagus nerve problems. No relevant concomitant medications were provided. On 02 Jan 2021, at 11: 30 am, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19. On 02 Jan 2021, about 8:30 pm, the patient stated she got really hot and didn't feel good. She mentioned she had a history of vagus nerve problems, and this reminded her of that experience when she felt like she would pass out. The patient said she felt like she was having a seizure and her head kept moving back and forth. She mentioned having a tremendous amount of mucus in her nasal cavity. She stated she still didn't feel like herself at the time. On 19 Jan 2021 the patient stated she felt a bit better. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the events, really hot, didn't feel good, felt like she was having a seizure, head kept moving back and forth, and tremendous amount of mucus from her nasal cavity, were resolving.; Reporter's Comments: This case concerns a 76-year-old, female patient with medical history of vagus nerve problems, who experienced serious, unexpected event of seizure like phenomenon and non serious, unexpected event of hot flush, malaise and mucus discharge. The event occurred 9 hours after the first dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/02/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Vagus nerve disorder,,,"['Dizziness', 'Dyskinesia', 'Feeling abnormal', 'Feeling hot', 'Head titubation', 'Malaise', 'Rhinorrhoea', 'Seizure like phenomena']",1,MODERNA,OT 996914,CA,58.0,F,"feel unwell most of the day; extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only worked 3 hours/day; pain in injection site, spread within 6 hours to all joints; pain in injection site, spread within 6 hours to all joints; headache; severe pain all muscles; nausea; This is a spontaneous report from a contactable other health professional (patient herself). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 31Dec2020 12:30 in right arm at single dose for covid-19 immunization. Medical history included asthma, fibromyalgia, perimenopause issues. The patient was known allergies: amlodipine; yellow jackets/hornets. The patient had COVID-19 prior vaccination. No other vaccine in four weeks were taken. Concomitant medication in two weeks included fluticasone propionate, salmeterol xinafoate (ADVAIR), zolpidem tartrate (AMBIEN), estradiol, mepolizumab (NUCALA) and oxycodone. Facility type vaccine was nursing home/senior living facility. On 01Jan2021, patient experienced pain in injection site, spread within 6 hours to all joints, then within 24 hours had headache, severe pain all muscles, nausea, and extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only worked 3 hours/day. All symptoms persist. Day 18 not in bed, but patient felt unwell most of the day on 18Jan2021. Lots of rest was required not normal for her. Events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included COVID-19 antibody test: positive on an unspecified date and nasal swab: negative on 15Jan2021. No treatment was received for events. Outcome of events at the reporting time were recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fatigue and other reported events due to temporal relationship. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/01/2021,1.0,SEN,ADVAIR; AMBIEN; ESTRADIOL; NUCALA; OXYCODONE,,Medical History/Concurrent Conditions: Allergy to insect sting; Asthma; COVID-19; Fibromyalgia; Perimenopause,,,"['Arthralgia', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Myalgia', 'Nausea', 'SARS-CoV-2 antibody test positive', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 996916,NJ,81.0,F,"trouble with dry eyes; infection in her eye; blood sugar 54 mg/dl two hours after dinner with insulin, 147 mg/dl after candy, 85 mg/dl after oatmeal without insulin, 196 mg/dl after; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ6796), via an unspecified route of administration in the left arm on 18Jan2021 11:00 at a single dose for COVID-19 immunization. The patient's medical history included ongoing type 2 diabetes mellitus, bladder cancer from 2005 and ongoing (cleaned it out, but has to go for check ups every 6 months), stent in artery in neck on right side on 2011, atrial fibrillation (Afib), knee total replacement on 2010 and on 2015, and ablations on Jan2010 and on Jun2010. Ongoing concomitant medications included insulin lispro (HUMALOG) and insulin glargine (LANTUS) both for type 2 diabetes mellitus. She took her regular insulin last night (19Jan2021) at dinner time and her blood sugar went down to 54 mg/dl about 2 hours later. She ate some candy and it went back up to 147 mg/dl. This morning (20Jan2021), it was 85 mg/dl. She just had oatmeal without taking any insulin which is unusual for her. She just took her blood sugar again and it's 196 mg/dl, which after eating oatmeal is not really high. The patient want to know if anyone else had this response. She felt great afterward and didn't even felt it. She also had an incident with an infection in her eye yesterday (19Jan2021), but the doctor didn't think it was related to the vaccine. She just had one little tingle of it on an unspecified date and went right to the doctor and they gave her medication for the infection. She has plugs in both eyes so she has trouble with dry eyes on an unspecified date. Outcome of the eye infection was recovering while of the remaining events was unknown. Information on lot number/batch number was requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/19/2021,1.0,UNK,HUMALOG; LANTUS,"Bladder cancer (Cleaned it out, but has to go for check ups every 6 months.); Type 2 diabetes mellitus",Medical History/Concurrent Conditions: AFib; Carotid artery stent insertion; Exeresis; Knee total replacement;,,,"['Blood glucose abnormal', 'Eye infection']",1,PFIZER\BIONTECH, 996917,,65.0,F,"severe ringing to ears for four days; throat was a bit congested; difficulty of swallowing; something stuck in the throat; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date: unknown), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to ask if it is normal to have severe ringing to ears especially in the morning. The patient received the COVID 19 vaccine last 16Jan2021. The patient reported symptoms which she has been experiencing for 4 days now with the COVID 19 vaccine, Pfizer's. She experienced severe ringing to ears for four days since 16Jan2021, it has been happening for four days, and usually happens in the morning and also, in Jan2021, there was something stuck in the throat, like her throat was a bit congested with difficulty of swallowing. The throat was being ok now, it's getting better, but the severe ringing to her ears was her main concern. The patient was recovering from the events ""something stuck in the throat"", ""throat was a bit congested"" and ""difficulty of swallowing"" while the event ""severe ringing to ears for four days"" had not resolved. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/01/2021,,UNK,,,,,,"['Dysphagia', 'Oropharyngeal discomfort', 'Tinnitus']",UNK,PFIZER\BIONTECH, 996918,,30.0,M,"Bell's Palsy; This is a spontaneous report from a non-contactable nurse (patient's wife). A 4-decade-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at a single dose for COVID-19 immunization. Medical history included Herpes Zoster (chicken pox and shingles), and hypogammaglobulinemia from an unknown date. The patient's concomitant medications were not reported. The reporter asked if her husband should receive his 2nd dose of vaccine after experiencing Bell's Palsy 12 hours after 1st dose. The patient had history of herpes zoster (chicken pox, shingles) on the same side of his face as the paralysis now (Bells Palsy). The patient was in a lot of pain and asked how serious Bell's Palsy is. Outcome of the event was unknown. No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bell's palsy cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Chickenpox; Hypogammaglobulinemia; Shingles,,,"['Facial paralysis', 'Incorrect dose administered', 'Pain']",1,PFIZER\BIONTECH, 996919,,,U,"Bell's palsy; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced bell's palsy on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Facial paralysis'],1,PFIZER\BIONTECH, 996920,RI,64.0,F,"faintness; fevers 101.5. Day 3 102.7; myalgia; fatigue; tracheitis; Respiration 40; This is a spontaneous report from a contactable physician (patient). A 64-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3426, expiration date: unknown), via an unspecified route of administration on the left arm on 16Jan2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included cardiac hypertrophic cardiomyopathy. The patient has no known allergies. Concomitant medications were not reported. No other vaccine in four weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm on 24Dec2020 at the age of 64 years old, lot number: Ek9231. On 16Jan2021 at 11:00 PM, the patient experienced faintness, fevers at 101.5 and 102.7 (on day 3), myalgia, fatigue, tracheitis for 3.5 days- stopped around 4AM on Wednesday, and respiration rate of 40. The patient has no COVID prior vaccination and has not tested for COVID post vaccination. The patient underwent lab tests and procedures which included body temperature: 101.5 on 16Jan2021, heart rate (HR): 80 on 16Jan2021, respiration: 40 on 16Jan2021 and body temperature: 102.7 on 20Jan2021. No treatment was administered for the events. The patient recovered from the event tracheitis on 20Jan2021 at 04:00 while recovering from the rest of the events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Faint cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/16/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Hypertrophic cardiomyopathy,,,"['Fatigue', 'Myalgia', 'Pyrexia', 'Syncope', 'Tracheitis']",2,PFIZER\BIONTECH, 996921,MN,35.0,F,"Bell's palsy / pain in the left side of her face / pain irradiated to ear and jaw / tingling sensation in left side of the forehead / facial weakness; This is a spontaneous report from a contactable Physician reported for self. This 35-Year-old-female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 15Jan2021 08:20 on Arm left at single dose for covid-19 immunisation. No other vaccine in four weeks. No Covid prior vaccination. No known allergies. None concomitant medication included. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Dec2020 08:20 AM at the age of 35 year old via IM Injection Upper Left Arm for covid-19 immunisation, no reactions with first dose and flu vaccine, Expiry Date: Oct2020 for immunization and no reactions. The patient experienced Bell's palsy on 19Jan2021 and received prednisone 60 mg for 7 days. The same day of the vaccination (15Jan2021), she started to experience pain in the left side of her face, aggravated by 18Jan2021, her pain irradiated to ear and jaw. On Saturday 16 post vaccinated, she experienced also tingling sensation in left side of the forehead on 16Jan2021. She experienced facial weakness on 19Jan2021. And in 19Jan Monday evening Bells Palsy was confirmed. Lab data included Physical exams: weakness in the left side of forehead. No Covid tested post vaccination. Outcome of the event Bell's palsy was recovering. Outcome of other events was unknown. There was a reasonable possibility that the event Bell's palsy was related to BNT162B2. Information on Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/19/2021,4.0,OTH,,,,,,"['Ear pain', 'Facial pain', 'Facial paralysis', 'Facial paresis', 'Pain', 'Pain in jaw', 'Paraesthesia', 'Physical examination normal']",2,PFIZER\BIONTECH,OT 996922,,,F,"Immunocompromised; tested positive for SARs-Cov-2; tested positive for SARs-Cov-2; This is a spontaneous report from a contactable pharmacist. A 6-decade-old (reported as 50s) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose, and then received the second dose in Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller on behalf of patient in ED. Frontline medical worker received the second dose of vaccine twelve days before in Jan2021. Patient was tested positive for SARs-Cov-2. Immunocompromised. Questioning the administration of Bamlanivimab. Potential AE. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. Immunocompromised is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/01/2021,,UNK,,,,,,"['COVID-19', 'Immunodeficiency', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 996923,CA,66.0,M,"Possible Bells Palsy; This is a spontaneous report from contactable other healthcare professional (HCP). A 66-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), intramuscular on 13Jan2021 at a single dose for COVID-19 Immunization. Medical history included hyperlipidemia, chronic kidney disease, essential hypertension, obesity, hyperuricemia, iron deficiency anemia, type 2 DM and obstructive sleep apnea. The patient has no known allergies. Concomitant medications included amlodipine besylate (AMLODIPINE BESYLATE), glimepiride (AMARYL [GLIMEPIRIDE]), levothyroxine sodium (LEVOTHYROXINE SODIUM), metformin (METFORMIN), losartan potassium (LOSARTAN POTASSIUM), ascorbic acid, calcium, minerals NOS, retinol, tocopheryl acetate, vitamin B NOS, vitamins NOS, zinc (CENTRUM SILVER [ASCORBIC ACID; CALCIUM; MINERALS NOS; RETINOL; TOCOPHERYL ACETATE; VITAMIN B NOS; VITAMINS NOS; ZINC]), sucralfate (SUCRALFATE), glimepiride (GLIMEPIRIDE), furosemide (FUROSEMIDE), atorvastatin (LIPITOR [ATORVASTATIN]), pantoprazole sodium (PANTOPRAZOLE SODIUM), cyclobenzaprine (CYCLOBENZAPRINE), cholestyramine (CHOLESTYRAMINE). Other vaccine in four weeks included the first dose of influenza vaccine, intramuscular on the left deltoid, on 22Dec2020, lot number: UJ475AA. The patient has no COVID prior vaccination and had not tested post vaccination. The patient experienced possible Bell's palsy on 14Jan2021. Treatment for the event was unknown. The event resulted in doctor or other healthcare professional office/clinic visit. The patient had not recovered from the event. Information on the batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bell's palsy cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,PHM,AMLODIPINE BESYLATE; AMARYL [GLIMEPIRIDE]; LEVOTHYROXINE SODIUM; METFORMIN; LOSARTAN POTASSIUM; CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS; SUCRALFATE; GLIMEPIRIDE; FUROSEMIDE; LIPIT,,Medical History/Concurrent Conditions: Chronic kidney disease; Essential hypertension; Hyperlipidemia; Hyperuricemia; Iron deficiency anemia; Obesity; Obstructive sleep apnea syndrome; Type 2 diabetes mellitus,,,['Facial paralysis'],1,PFIZER\BIONTECH,OT 996927,NY,73.0,F,"O2 sat 70% on RA; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; This is a spontaneous report from a contactable physician. A 73-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose intramuscular on 03Jan2021 for Covid-19 immunisation, administered at nursing home/senior living facility. Medical history included alcohol use, diverticulitis, iron deficiency anaemia (IDA), asthma, hypertension, anxiety, recent C. diff infection, allergies to penicillin. She was not pregnant. The patient had not experienced Covid-19 prior vaccination. Concomitant medication included apixaban (APIXABAN), bioflavonoids nos, calcium ascorbate, hesperidin, rutoside, sodium ascorbate, zinc amino acid chelate (VITAMIN C [BIOFLAVONOIDS NOS;CALCIUM ASCORBATE;HESPERIDIN;RUTOSIDE;SODIUM ASCORBATE;ZINC AMINO ACID CHELATE]), cyanocobalamin (B-12), furosemide (LASIX), simethicone (manufacturer unknown), tramadol (manufacturer unknown), vancomycin (manufacturer unknown) oral, omeprazole (PROTONIX), amlodipine (manufacturer unknown), vitamins nos (MULTIVITAMIN), thiamine (manufacturer unknown), aripiprazole (ABILIFY), atorvastatin calcium (LIPITOR), clonazepam (KLONOPIN), folic acid (manufacturer unknown), sertraline hydrochloride (ZOLOFT). The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 10Jan2021, 7 days after getting vaccine, the patient developed shortness of breath and fatigue, rheumatoid arthritis, O2 sat 70% on RA, now intubated and in multiorgan failure. The events resulted in Emergency room/department or urgent care, hospitalization, life threatening illness for immediate risk of death from the event. The patient was hospitalized for the events for 18 days. Patient received treatment with corticosteroids, antibiotics, antifungals, dialysis, mechanical ventilation, inhaled Epoprostinol. The patient underwent lab tests and procedures which included SARS-CoV-2 test: unknown in Jan2021. Pre / post vaccination, the patient has been tested for COVID-19 with unknown result. The with outcome of events was not recovered.; Sender's Comments: Based on the temporal gap between the vaccination and the event onset, the Company considered that there was not a reasonable possibility that the events were related to suspect vaccine BNT162B2. The patient's advanced age, underlying medical conditions and multiple concomitant medications could be contributory to the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,,Not Reported,N,01/03/2021,01/10/2021,7.0,SEN,APIXABAN; VITAMIN C [BIOFLAVONOIDS NOS;CALCIUM ASCORBATE;HESPERIDIN;RUTOSIDE;SODIUM ASCORBATE;ZINC AMINO ACID ; B-12; LASIX [FUROSEMIDE]; SIMETHICONE; TRAMADOL; VANCOMYCIN; PROTONIX [OMEPRAZOLE]; AMLODIPINE; MULTIVITAMIN [VITAMINS NOS]; THI,,Medical History/Concurrent Conditions: Alcohol use; Anxiety; Asthma; Clostridium difficile infection; Diverticulitis; Hypertension; Iron deficiency anemia; Penicillin allergy,,,"['Apparent life threatening event', 'Dyspnoea', 'Endotracheal intubation', 'Fatigue', 'Multiple organ dysfunction syndrome', 'Rheumatoid arthritis', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 996956,PA,90.0,F,"Positive Covid case investigation with the PA DOH. Spoke with case's daughter. States her mother recieved vaccine at clinic on 01/27/21. Had no complaints of illness or exposure to a positive case prior to vaccine. Daughter states she's independent and stays alone at night. Felt fine the day and the day after of the vaccine. Per daughter, case's last known well time was Friday 1/29/21 at 730pm. Daughter states they found her Saturday morning with stroke like symptoms and was admitted to Hospital step down unit. She was also informed by the doctor that her heart was irregular with atrial fibrillation.",Not Reported,,Yes,Yes,,Yes,N,01/27/2021,01/30/2021,3.0,PVT,,NONE,"TIAX2, HTN, DM",,,"['Atrial fibrillation', 'Cerebrovascular accident', 'Heart rate irregular', 'Neurological symptom']",7+,MODERNA,IM 996959,OH,78.0,M,Vaccine was administered Thursday and my father Died early Monday morning unexpectedly,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,01/01/2021,02/01/2021,31.0,PHM,"Lasix, Morphine, Ernesto, Oxycodone, omeprazole Gabapentin",CHF. COPD Chronic Pain,"CHF, COPD, Polio as a child",,None,['Death'],1,PFIZER\BIONTECH,IM 997133,KY,80.0,M,hospitalized for GI Bleed and found to be COVID positive on admission.,Not Reported,,Not Reported,Yes,,Yes,N,01/29/2021,02/02/2021,4.0,PVT,,,"status post angioplasty, diabetes, neuropathy.",,NKA,"['COVID-19', 'Gastrointestinal haemorrhage', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 997145,NY,85.0,F,"85 year old patient with multiple medical problems. PEA/asystolic arrest 5 days after receiving vaccine, hospitalized. Patient died on 2/1/2021. It is not clear whether the vaccine administration led to the patient's death or not. ""...healthcare professionals are encouraged to report any clinically significant or unexpected events (even if not certain the vaccine caused the event)""",Yes,02/01/2021,Not Reported,Yes,7.0,Not Reported,N,01/21/2021,02/01/2021,11.0,PVT,,,"diabetes, cancer, COPD, hypertension",,,"['Cardiac arrest', 'Cerebral infarction', 'Computerised tomogram abnormal', 'Death', 'Pulseless electrical activity']",1,MODERNA,IM 997226,CA,52.0,F,"Bleeding/ gastro intestinal bleeding; Bleeding/ gastro intestinal bleeding; woke up with chest pain; tachycardia; body ache; headache; This is a spontaneous report from a contactable other HCP reported for self. A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686), via an unspecified route of administration at left arm on 13Jan2021 12:00 PM (that is 14Jan2021 00:00) at SINGLE DOSE for COVID-19 immunization. No Covid prior vaccination. Medical history included allergy to shellfish and Iodine, Kidney and pancreas transplant 10 years ago. Concomitant medications in two weeks includes mycophenolate sodium (MYFORTIC), Tacrolimus, Prednisone, Trazodone. The patient previously received first dose of BNT162B2 (Lot number: EJ1686), at left arm on 24Dec2020 14:30. No Other vaccine in four weeks. On 14Jan2021 09:30 AM, patient woke up the next morning with chest pain, tachycardia, body ache, headache, bleeding. Symptoms lasted from Thursday to Monday. A total of 5 days. Patient have never suffered from a headache and as of 20Jan2021, patient still had it. Every day got better and no longer have the other symptoms. The only other one is the gastro intestinal bleeding. Patient only see few spots of blood when go to the bathroom. She believed that is gastrointestinal because almost never had a period as a teen. No treatment received. Not tested covid post vaccination. Outcome of ""Bleeding"", ""Gastrointestinal bleeding"" was not recovered, of ""headache"" was recovering, of other events was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events haemorrhage and gastrointestinal haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,PVT,MYFORTIC; TACROLIMUS; PREDNISONE; TRAZODONE,,Medical History/Concurrent Conditions: Kidney transplant (10 years ago); Pancreas transplant (10 years ago); Shellfish allergy,,,"['Chest pain', 'Gastrointestinal haemorrhage', 'Haemorrhage', 'Headache', 'Pain', 'Tachycardia']",2,PFIZER\BIONTECH, 997228,TX,53.0,M,"Syncope/a complete syncopal episode while standing. Then a 2nd one on return; unconscious approximately 30 seconds each time; chills; fatigue; muscle aches; joint aches; headaches; extreme dizziness and nausea; extreme dizziness and nausea; injure a knee when my legs pretzeled on the 2nd syncopal episode.; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 53-year-old male patient received second dose of BNT162B2 (COVID-19 Pfizer/Biontech, Lot#: EL3248), via an unspecified route of administration on 13Jan2021 11:00 AM on Left arm at single dose for COVID-19 immunisation. Medical history included Controlled hypertension and known allergies: Hypersensitive to narcotics. Concomitant medications included Amlodipine, Irbesartan and Atoravastin. The patient previously took first dose of BNT162B2 (COVID-19 Pfizer/Biontech, Lot#: EK9231), via an unspecified route of administration on 23Dec2020 11:00 AM on Left arm at single dose for COVID-19 immunisation. Facility type Vaccine was Hospital. No Other vaccine in four weeks. The patient experienced Syncope. He had the most common severe reactions (chillls, fatigue, muscle aches, joint aches, headaches). But when he walked to bathroom, he had extreme dizziness and nausea, then a complete syncopal episode while standing. Then a 2nd one on return. His wife said he was unconscious approximately 30 seconds each time. EMS was called but refused transport since ERs full. The patient did also injure a knee when his legs pretzeled on the 2nd syncopal episode. The events started from 16Jan2021 01:30 AM. The outcome of th events was recovered. No treatment received. No Covid prior vaccination. No covid tested post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/16/2021,3.0,PVT,AMLODIPINE; IRBESARTAN; ATORVASTATIN,,Medical History/Concurrent Conditions: Drug allergy (known allergies: Hypersensitive to narcotics); Hypertension (Controlled hypertension),,,"['Arthralgia', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Joint injury', 'Loss of consciousness', 'Myalgia', 'Nausea', 'Syncope']",2,PFIZER\BIONTECH, 997230,NM,49.0,F,"Vasovagal reaction; allergic reaction to vaccine; became lightheaded, dizzy; mildly short of breath; developed a headache/onset 6 out of 10 left-sided frontal headache; chest tightness; room is spinning around her however does not feel that she is presyncopal; This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJ1685; expiration date: unknown), intramuscular left arm on 18Dec2020 20:00 at a single dose for covid-19 immunization. Medical history included wheezing, hypertension, hyperlipidaemia and non-insulin-dependent diabetes. She was not diagnosed with Covid prior to vaccination. The patient has no known allergies. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medication included salbutamol sulfate (ALBUTEROL) for wheezing, fluticasone propionate (FLOVENT HFA), hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS), pravastatin, colecalciferol (VIT D3), colecalciferol (VITAMIN D3 1000), latanoprost and metformin. The patient did not receive other vaccine in the last four weeks. On 18Dec2020, the patient reported that she received her first Covid 19 vaccination shot in a hospital and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She further reported that her symptoms occurred approximately 10 to 15 minutes (reported onset time of 08:00 PM) after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal. The impression was vasovagal reaction with mild allergic reaction to vaccine. The adverse events resulted in an emergency room/department or urgent care visit and treatment was received for the adverse events which included ketorolac 15mg x 1 dose, meclizine 25mg x 1 dose, NaCl 1,000 mL bolus. The patient was not COVID tested post vaccination. The outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,ALBUTEROL [SALBUTAMOL SULFATE]; FLOVENT HFA; LATANOPROST; LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS; METFORMIN; PRAVASTATIN; VIT D3; VITAMIN D3 1000,,Medical History/Concurrent Conditions: Hyperlipidemia; Hypertension; Non-insulin-dependent diabetes mellitus; Wheezing,,,"['Adverse event', 'Chest discomfort', 'Dizziness', 'Dyspnoea', 'Headache', 'Hypersensitivity', 'Presyncope']",1,PFIZER\BIONTECH,OT 997231,MO,,F,"Double ear infection; Mild bronchitis; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program Pfizer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 002191), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received her first dose of the vaccine and is scheduled for her second dose on Friday (unspecified date). On an unspecified date, the patient was diagnosed with a double ear infection and mild bronchitis and was given penicillin in shot form and is on a Z-Pak. The patient asked if it okay that she gets her second dose as scheduled or if she needs to wait until she is done with her antibiotics. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Bronchitis', 'Ear infection']",1,PFIZER\BIONTECH, 997233,HI,54.0,M,"tunnel vision; little woosy; This is a spontaneous report from a contactable consumer reporting for himself. A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982) in left arm on 19Jan2021 08:30 at single dose for COVID-19 immunization. Medical history included shellfish allergy, asthma and high cholesterol; all from an unknown date and unknown if ongoing. Concomitant medication included simvastatin. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced events as stated, ""like I was seeing tunnel vision and a little woosy"" on 19Jan2021 13:00. No treatment was given to the patient for the events. The outcome of the events was recovered on unspecified date. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and were not a congenital anomaly/birth defect.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,PVT,SIMVASTATIN,,Medical History/Concurrent Conditions: Asthma; High cholesterol; Shellfish allergy,,,"['Dizziness', 'Tunnel vision']",1,PFIZER\BIONTECH, 997234,ME,53.0,F,"Chest tightness; wheezing; wheezing; throat swelling; tongue tingling; lip numbness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration in the left arm on 18Jan2021 17:15 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and asthma, both from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE on 28Dec2020 at 01:15 PM (lot number: EL1284) in the left arm for COVID-19 immunization given when the patient was 53 years old. The patient did not receive any other vaccine in four weeks prior to covid vaccine. She had known allergies which were not specified. She was not pregnant. The patient experienced chest tightness, wheezing, throat swelling, tongue tingling and lip numbness, all on 18Jan2021 at 05:45 PM with outcome of recovering. The events resulted to Emergency room/department or urgent care. Treatment received for all events included DECADRON and Benadryl script for Epipen. The patient had no covid prior vaccination. She was tested for covid post vaccination through nasal swab on 20Jan2021 with pending result.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of chest tightness, wheezing, throat swelling, tongue tingling and lip numbness due to temporal relationship. However, the chest tightness, wheezing may possibly be associated with the patient's history of asthma. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray and pulmonary function tests, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/18/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Asthma; Blood pressure high,,,"['Chest discomfort', 'Hypoaesthesia oral', 'Paraesthesia oral', 'Pharyngeal swelling', 'SARS-CoV-2 test', 'Wheezing']",2,PFIZER\BIONTECH, 997236,FL,,F,"she couldn't walk, clarifying that her legs were almost paralyzed feeling, and she couldn't get a walking gate on her legs; Immediate reaction ""breathy""; from the injection site of the COVID-19 Vaccine, she immediately felt heat go down her arms and legs; she said she had ""chemo shakes"", clarifying she had a kind of shivering or uncontrolled shakes; she said she had ""chemo shakes"", clarifying she had a kind of shivering or uncontrolled shakes; she had loose bowels/bowel movements were not liquid, but the bowel movements were not normal; exhausted/feels worn out; flushing in her face; her face feels hot/warm in her chest; her nose and cheeks get a sunburn heat feeling, and the heat feeling is on and off/Feels like she has a sulfur burn on her face; her skin on her arms and legs starts to feel prickly when she has the heat feeling on her nose and cheeks; bitter taste in her mouth; her blood pressure goes up/her blood pressure was like 138 or 142 over 72; having a temperature of 99, and then the temperature starts to spike; nervous; sensitivity she is having to the COVID-19 Vaccine; Enlarged lymph nodes in her neck/attacking her lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received her first dose of BNT162B2 (lot number: EL3246), via an unspecified route of administration in the arm, left upper on 09Jan2021 11:45 at single dose for Covid-19 immunization. Medical history included ongoing chronic lymphocytic leukaemia (CLL) from 2008, allergic to sulfur, chemo, doesn't have a spleen because she had a bad accident 25 years ago (unspecified date in 1996). Concomitant medication included ibrutinib (IMBRUVICA) for CLL. She has been taking IMBRUVICA, but not consistently. She said she doesn't take it when she is feeling good because IMBRUVICA has side effects. The patient had intolerance to ciprofloxacin (CIPRO). There were no additional vaccines administered on same date of BNT162B2. The patient white blood cell count is 68000 and a normal white blood cell count is 10000. She said all her other blood work is very good. She said if she takes IMBRUVICA her white blood cell count goes down to 30000. She said IMBRUVICA will initially quadruple her white blood cell count before the IMBRUVICA will make her white blood cell count go down. She said she is mostly on the IMBRUVICA. She said if she tries to go off IMBRUVICA her White Blood Cell count goes up. The patient is calling about the Pfizer COVID19 Vaccine. She received the first dose of vaccine 09Jan2021, and the patient had an immediate reaction ""breathy"". She said she had a reaction right when she got the COVID-19 Vaccine, and now it is the 11th day already and she is beside herself. The patient reported that on 09Jan2021 from the injection site of the COVID-19 Vaccine, she immediately felt heat go down her arms and legs. She said she was told to go sit for a while, and that what she was experiencing would pass. She said what she experienced didn't pass. She said she got ""chemo shakes"", clarifying she had a kind of shivering or uncontrolled shakes. Reported she had to go to the bathroom 3 times while she was waiting for her side effects to improve. She clarified she had loose bowels. She said her bowels were good after the 1st week of receiving the COVID-19 Vaccine, but yesterday or 2 days ago, she had loose bowel movements. She said the bowel movements were not liquid, but the bowel movements were not normal. She had stayed at the vaccination facility site for over an hour after receiving the COVID-19 Vaccine. She said she couldn't walk, clarifying that her legs were almost paralyzed feeling, and she couldn't get a walking gate on her legs. She said after waiting for over an hour after receiving the COVID-19 Vaccine, she was exhausted and went home. Reported it took her at least 3 hours before some of her side effects started to go away. She said she is not finished with her side effects, saying it has been 11 days since she received the COVID-19 Vaccine, and she is still suffering. All events happened on 09Jan2021.She has CLL, clarifying she has Leukemia. On unspecified date in Jan2021, she found lumps (clarified as enlarged lymph nodes) under her neck 4 days after she stopped taking IMBRUVICA. She said the enlarged lymph nodes started to come back on her neck sooner than she expected. She clarified if she stops taking IMBRUVICA in preparation for a dental visit, she can be off of IMBRUVICA for 2 weeks and not have enlarged lymph nodes come back on her neck like after getting the COVID-19 Vaccine. She said the COVID-19 Vaccine is attacking her lymph nodes. She said she doesn't like mixing 2 medications (IMBRUVICA and COVID-19 Vaccine), but will have to go back on the IMBRUVICA, and hope her enlarged lymph nodes will go down. She said her cancer doctor told her not to take IMBRUVICA until she was feeling better. She clarified that IMBRUVICA is not a chemo medication. She said the last time she had chemo was when she had spiked in 2015 and had 4 chemo treatments. Also, it was reported that on 09Jan2021, she has flushing in her face, and her face feels hot, her nose and cheeks get a sunburn heat feeling, and the heat feeling is on and off, her skin on her arms and legs starts to feel prickly when she has the heat feeling on her nose and cheeks. As treatment, her cancer doctor told her to take Benadryl, she clarified she is taking Children's Benadryl, Cherry flavored. She said she has no idea how much Children's Benadryl she should be taking. She is taking Pedialyte and a (Pharmacy name) version of Pedialyte because she felt her whole system is off. She stated she has had no temperature, and her vitals were good, but yesterday on unspecified date in Jan2021, she got flushed, she gets nervous, and her blood pressure goes up. She said her blood pressure was like 138 or 142 over 72. She clarified her blood pressure was really good the first week after receiving the COVID-19 Vaccine (Jan2021). Reported her body feels like she went through something. She said her cancer doctor told her not to take the second COVID19 Vaccine dose. She said her cancer doctor recommended she get the COVID-19 Vaccine because all her blood work looked good before she got the first COVID-19 Vaccine dose. she doesn't have a spleen because she had a bad accident 25 years ago. She said maybe her not having a spleen creates the sensitivity she is having to the COVID-19 Vaccine (onset date in Jan2021). She said she doesn't get the flu vaccine. She said she looked at the papers she was given when she got the COVID-19 Vaccine and wanted to notify Pfizer and see if she could get some help as to what she should do. She said she asked her cancer doctor what she should do, and he told her he is not an expert. She said she has had every side effect listed on the COVID-19 Vaccine paperwork, but she doesn't have the blushing on her face that was listed on the paperwork. She said Pfizer should have a hotline for people to check in. She said she wants to know that she is doing the right thing, and that the COVID-19 Vaccine is not killing her. She asked if she is getting blood work in 3 weeks, will the blood work show if she has antibodies from the COVID-19 Vaccine. She was offered transfer to Pfizer Medical Information for further assistance. She forgot to mention that as soon as she got the COVID-19 Vaccine, she had a bitter taste in her mouth on 09Jan2021. She said when she starts getting hot in her cheeks, the bitter taste comes back in her mouth. Reported usually by 4:00PM she starts getting the heat in her face, but no temperature. She said she feels like she has a temperature now, clarifying it is like having a temperature of 99, and then the temperature starts to spike on unspecified date in Jan2021. She said if she did have a high temperature, she would put herself in the hospital immediately. She said she is sometimes warm in her chest, when she is having the feeling of a temperature spike. Reported she feels worn out. She said it is not like being tired where you go to sleep and wake up feeling better. She said her body is out of sync. She said it is like the body goes through shock and is trying to get back into balance. She called the specialty pharmacist to see if there was anything in the COVID-19 Vaccine that could interact with the IMBRUVICA. She said the specialty pharmacist told her there is nothing interactive with the COVID-19 Vaccine because the COVID-19 Vaccine is not a live vaccination. Reported she is allergic to sulfur. She said she feels like she has a sulfur burn on her face, if she didn't have the heat on her face too. She said the enlarged lymph nodes on her neck below her chin are very stressful. She said every side effect listed on the COVID-19 Vaccine paperwork; she has. She said the COVID-19 Vaccine paperwork mentioned lymph nodes. Therapeutic measures were taken as a result of the following events: she couldn't walk, clarifying that her legs were almost paralyzed feeling, and she couldn't get a walking gate on her legs; immediate reaction ""breathy""; from the injection site of the covid-19 vaccine, she immediately felt heat go down her arms and legs; she said she had ""chemo shakes"", clarifying she had a kind of shivering or uncontrolled shakes; she had loose bowels/bowel movements were not liquid, but the bowel movements were not normal; exhausted/feels worn out; enlarged lymph nodes in her neck/attacking her lymph nodes; flushing in her face; her face feels hot/warm in her chest; her nose and cheeks get a sunburn heat feeling, and the heat feeling is on and off/feels like she has a sulfur burn on her face; her skin on her arms and legs starts to feel prickly when she has the heat feeling on her nose and cheeks; having a temperature of 99, and then the temperature starts to spike. The outcome of the events Immediate reaction ""breathy"", nervous, sensitivity she is having to the COVID-19 Vaccine, her blood pressure goes up/her blood pressure was like 138 or 142 over 72, having a temperature of 99, and then the temperature starts to spike was unknown. The events she couldn't walk, clarifying that her legs were almost paralyzed feeling, and she couldn't get a walking gate on her legs and ""chemo shakes"", clarifying she had a kind of shivering or uncontrolled shakes recovered on 09Jan2021. The outcome of the remaining events was not recovered.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/09/2021,01/01/2021,,UNK,IMBRUVICA,CLL,Medical History/Concurrent Conditions: Accident (25 years ago); Chemotherapy (had chemo was when she had spiked in 2015 and had 4 chemo treatments); Splenectomy (because she had a bad accident 25 years ago); Sulfonamide allergy,,,"['Blood test normal', 'Body temperature increased', 'Burning sensation', 'Chills', 'Diarrhoea', 'Dysgeusia', 'Fatigue', 'Feeling abnormal', 'Feeling hot', 'Flushing', 'Gait disturbance', 'Gait inability', 'Hypertension', 'Immediate post-injection reaction', 'Lymphadenopathy', 'Neck mass', 'Nervousness', 'Paraesthesia', 'Respiration abnormal', 'Shock', 'Stress', 'Tremor', 'White blood cell count abnormal']",1,PFIZER\BIONTECH, 997238,CA,40.0,F,"tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles on face; numb face; Red spots on nose and legs; mottled leg color but looked like a flat rash; mottled leg color but looked like a flat rash; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1283 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 07:15 PM (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ1685 and Expiration Date unknown) via an unspecified route of administration on 31Dec2020 11:30 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included asthma, chronic migraines from neck injury, increased weight, known allergies to Reglan. No covid prior vaccination. The concomitant medications was reported as pregabalin (LYRICA), cefixime (FLEXERIL), sertraline hydrochloride (ZOLOFT), omeprazole (PROTONIX), sumatriptan succinate (IMITREX).On 19Jan2021 08:00 PM, patient experienced pins and needles on face. Then numb face. Red spots on nose and legs. Then mottled leg color but looked like a flat rash. Next day (20Jan2021) tip of nose still funny feeling. Spots remain. Slight dry cough, clearing throat, hoarse voice. Events resulted in Emergency room/department or urgent care. Treatment information included IV fluid, Benadryl, pepcid, steroids.The outcome of events was recovering after treatment given. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,WRK,LYRICA; FLEXERIL [CEFIXIME]; ZOLOFT; PROTONIX [OMEPRAZOLE]; IMITREX,,Medical History/Concurrent Conditions: Asthma; Chronic migraine (chronic migraines from neck injury); Neck injury; Weight increase (Increased weight),,,"['Cough', 'Dysphonia', 'Feeling abnormal', 'Hypoaesthesia', 'Livedo reticularis', 'Paraesthesia', 'Rash macular', 'Throat clearing']",2,PFIZER\BIONTECH, 997239,NC,,M,"Inflammatory fasciitis; cervical lymph nodes; This is a spontaneous report from a contactable physician reporting for another physician (Orthopedic surgeon). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not provided) on 12Jan2021 in left arm via an unspecified route of administration at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It's unknown if the patient had any known allergies. It's not provided if the patient had had COVID prior the vaccination or had every tested post the vaccination. The patient received the second dose of the vaccine on 12Jan2021 Tuesday and by Thursday 14Jan2021 he experienced severe left upper girdle pain in her shoulder and neck. Eventually he was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis. This was considered as an unusual post vaccine response. The patient was worried as he didn't know how transient or permanent this condition would be. Magnetic resonance imaging (MRI) on an unspecified date showed cervical lymph nodes and reports of lymphadenopathy from the clinical trial were discussed. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Fasciitis cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,01/12/2021,01/01/2021,,UNK,,,,,,"['Arthralgia', 'Fasciitis', 'Injection site pain', 'Lymphadenopathy', 'Magnetic resonance imaging abnormal', 'Magnetic resonance imaging neck', 'Neck pain']",2,PFIZER\BIONTECH, 997241,AL,56.0,F,"syncopal event; unable to move; increased respiratory rate; severe pain radiating from neck throughout body; unable to turn head; generalized weakness; hypotension; shortness of breath; unable to speak; chills; diaphoresis; severe pain radiating from neck throughout body; This is a spontaneous report from a contactable nurse (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1283), via an unspecified route of administration on 18Jan2021 10:45 at single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, shellfish. Concomitant medication included celecoxib (CELEXA), levocetirizine dihydrochloride (XYZAL), acetaminophen, ibuprofen, naproxen sodium. There were no other vaccines received in four weeks. The patient did not have Covid tested post vaccination. Upon awakening early morning after injection on 19Jan2021 04:00, the patient had severe pain radiating from neck throughout body, unable to turn head, generalized weakness, syncopal event, hypotension, increased respiratory rate, shortness of breath, unable to speak, unable to move, chills, diaphoresis, emergent to emergency department, received Intravenous NS bolus as treatment. Electrocardiogram (EKG), BMP, complete blood count (CBC), labs were Within Normal Limit on 19Jan2021, discharged home, slept all day. Feeling much better second day after injection. The reported events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of unable to move, syncopal event, increased respiratory rate, severe pain radiating from neck throughout body, unable to turn head, generalized weakness, hypotension, shortness of breath, unable to speak, chills, diaphoresis. The outcome of the events was recovered in Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/19/2021,1.0,PVT,CELEXA [CELECOXIB]; XYZAL; ACETAMINOPHEN; IBUPROFEN; NAPROXEN SODIUM,,Medical History/Concurrent Conditions: Shellfish allergy; Sulfonamide allergy,,,"['Aphasia', 'Asthenia', 'Chills', 'Dyspnoea', 'Electrocardiogram normal', 'Full blood count normal', 'Hyperhidrosis', 'Hypotension', 'Metabolic function test normal', 'Movement disorder', 'Musculoskeletal stiffness', 'Neck pain', 'Pain', 'Respiratory rate increased', 'Syncope']",UNK,PFIZER\BIONTECH, 997297,TN,85.0,M,"Death on 1/17/21. Death certificate reports: Septic Shock, UTI, Pneumonia, Chronic Renal Failure",Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/17/2021,13.0,PUB,,,,,,"['Chronic kidney disease', 'Death', 'Pneumonia', 'Septic shock', 'Urinary tract infection']",1,MODERNA,IM 997519,CA,,U,"Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Out of specification product use'],1,MODERNA,OT 997520,CA,,U,"Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Out of specification product use'],1,MODERNA,OT 997521,CA,,U,"Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Out of specification product use'],1,MODERNA,OT 997524,GA,64.0,F,"muscle swelling; welts/hives; muscle pain; eyes swelling; tongue swelling; shut throat; blood pressure elevated; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: eh9899, expiration date not reported), via an unspecified route of administration on 17Dec2020 15:15 at single dose on right arm for COVID-19 immunisation. Medical history included heart disease from an unknown date and unknown if ongoing. No Known allergies to the patient currently. The patient was not pregnant. Concomitant medication in two weeks included Rosuvastatin. The patient received the vaccine in hospital. No other vaccine administered in four weeks. The patient experienced muscle swelling, welts/hives, muscle pain, eyes swelling, shut throat/tongue swelling, and blood pressure elevated hospitalization continued symptoms now for 35 days. All adverse events (AEs) started on 17Dec2020. AEs resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization for two days. Patient received treatment (medications, IV's EKG many test) for AEs. No COVID prior vaccination. Patient did COVID tested post vaccination, COVID test post vaccination included Nasal Swab on 02Jan2021 with result of Negative. The outcome of events was not recovered.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/17/2020,12/17/2020,0.0,PVT,ROSUVASTATIN,,Medical History/Concurrent Conditions: Heart disorder,,,"['Blood pressure increased', 'Electrocardiogram', 'Eye swelling', 'Hypertension', 'Laboratory test', 'Muscle swelling', 'Myalgia', 'Pharyngeal swelling', 'SARS-CoV-2 test negative', 'Swollen tongue', 'Urticaria']",1,PFIZER\BIONTECH, 997525,,,M,"Pneumonia; scan showed infiltration in the lungs; coughing; absolute eosinophils were high 22.2 and came down to 4.8 now; This is a spontaneous report from a non-contactable consumer (wife). An 81-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included Running nose from 01Jan2021. The patient's concomitant medications were not reported. The patient received Covid vaccine on the 04Jan2021. She stated on 01Jan2021 he had running nose, had negative covid test so was given the Covid vaccine. She said 7 days after the first dose on 11Jan2021, he had pneumonia, was in the hospital, scan showed infiltration in the lungs, coughing. He was on the antibiotics and prednisone. The absolute eosinophils were high 22.2 and came down to 4.8 now. She wanted to know if that was an allergic reaction to the vaccine. No follow up attempts are possible. Information about Lot and batch number could not be obtained.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/04/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Runny nose,,,"['Computerised tomogram thorax', 'Computerised tomogram thorax abnormal', 'Cough', 'Eosinophil count increased', 'Lung infiltration', 'Pneumonia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 997526,OH,37.0,M,"it was so faint; he checked his temperature, it was 100.3; Body aches; aching in hips; Chills; little mild headache; arm started hurting/his arm was so sore; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in left arm on 19Jan2021 16:00 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were none. The patient on 19Jan2021 at about 4:00PM, got his first dose of vaccine, later clarified as COVID vaccine, and he was very energetic last night, he didn't feel the medicine going in, but today (20Jan2021), the more he was up, the worse he felt, and he checked his temperature, it was 100.3, and his employer said to not come in today, he knew can't get the virus from the vaccine, but this was not a side effect listed on the sheet. He had body aches, his arm, he can't hardly lift it, and last night he was so energetic and felt great, but his arm was so sore throughout the night, it woke him up, and he was aching in hips/aches primarily in his hips, he has hip issues, but was achy in that area. He was also starting to get a little mild headache, it was so faint right now, his symptoms came along the longer he was up, the more he was experiencing things. Primary care doctor's information declined, stated he didn't have one, he moved to another state, and didn't have one yet. Workplace said not to come if temperature was 100.4, but it's so borderline, so they said to stay home. Outcome: he had checked 4 times, and it kept saying 100.3. Overnight, his arm started hurting, but he got up today, and had chills and body aches. His arm was not hurting if he moved his arm, but other than that, he felt like something was there, but didn't ache or anything. The outcome of events faint, chills and headache was unknown, for events temperature was 100.3, body aches, arm hurting, and aching in hips was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Arthralgia', 'Chills', 'Feeling abnormal', 'Headache', 'Impaired work ability', 'Mobility decreased', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH, 997531,,50.0,M,"Narrative: Patient is a 49 year old man with past medical history of hypertension and kidney stones who presented with a chief complaint of word finding difficulties and slurred speech. Patient was last seen normal at 1230 pm on 1/21/2021. He got his covid vaccine and shortly after he developed a headache that was on both sides of his head. Felt like 8/10 pain. He then had difficulty with speaking - he didn't know what word to say so he would make a noise. He was on the phone, and that person recommended that he come to the ED to get evaluated.In the ED, a stroke code was called. BP 169/97. NIHSS 0. A CT non con did not show any acute bleed or any signs of a stroke. After the stoke code was ended, the patient has a headache severity 1/10 and did not have any word finding difficulties. Patient was non focal by the time that the stroke code was ended. In the setting of hypertension, a blood pressure of 169/97 on admission and fluctuating symptoms, most concerning on the differential is a TIA. Given his risk factors and episodic presentation, he will need to be worked up for a stroke. The differential also includes post-vaccination reaction vs complex migraine.",Not Reported,,Not Reported,Yes,,Not Reported,Y,,01/21/2021,,OTH,,,,,,"['Aphasia', 'Computerised tomogram head', 'Dysarthria', 'Headache', 'Hypertension', 'NIH stroke scale', 'Transient ischaemic attack']",UNK,MODERNA, 997546,FL,72.0,M,"Jan 2, 2021 patient received his first dose of the Monderna Vaccine at the County Health Department. He woke up on Janurary 3rd with a bloated somach, severe pain and nausea. He was in the ER at 6:00 am. diagnosed with acute pancreatititis (he did not drink alchol) He conditon declined during the month of Januray as he remained in he hospital gradually being moved to higer levels of care. On January 28 he endured open surgery to remove the gallbladder. On Januray 29 he passed. Doctors belive only slight chance his condition was caused by vaccine.",Not Reported,,Not Reported,Yes,26.0,Not Reported,N,01/02/2021,01/03/2021,1.0,PVT,mulit vitamins,"obesity, diabetic",obesity,,no,"['Abdominal distension', 'Abdominal pain upper', 'Cholecystectomy', 'Death', 'General physical health deterioration', 'Nausea', 'Pancreatitis acute']",UNK,MODERNA, 997550,MA,54.0,F,"First three days was just muscle soreness and fatigue. On day 4 I started having tight chest and SOB while snowshoeing, which I did not have the day before on same activity. That night I woke up with SOB and tightness in my chest and severe pain in area of my heart. I could not lay on my left side. It seemed like I was having heart attack symptoms. Barley slept but upon waking my heart rate was 94 and the pain remained in LT Axilla area. Took it easy for day and that night again had trouble sleeping, SOB but not as bad. Woke up with excrutiating pain radiating up the base of my RT skull. Was concerned about blood clot potential?? Had SOB when walking up stairs. My throat hurt when bending over, as if my esophagus was crushing. Friends said my face looked puffy and I felt bloated. Landed up reporting to ER at the Hospital on Monday, Feb. 1st as directed by my PCP. Hospital was told I had just had 2nd dose of vaccine, but did not think it was related. I will mention all tests below, but upon arriving home on Feb. 2nd, I discovered a rash breaking out on underside of my LT upper arm, LT inner thigh and LT lower leg.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/27/2021,01/30/2021,3.0,PVT,verapamil-for vertigo off label usage fish oil multivitamin,none,Chronic dry eye Vertigo,,Penicillin,"['Abdomen crushing', 'Abdominal distension', 'Axillary pain', 'Blood magnesium normal', 'Chest X-ray normal', 'Chest discomfort', 'Chest pain', 'Dyspnoea', 'Dyspnoea exertional', 'Electrocardiogram normal', 'Fatigue', 'Full blood count normal', 'Glycosylated haemoglobin', 'Haemoglobin normal', 'Headache', 'Heart valve incompetence', 'Lipids normal', 'Metabolic function test normal', 'Myalgia', 'Oropharyngeal pain', 'Pain', 'Rash', 'SARS-CoV-2 test negative', 'Sleep disorder', 'Stress echocardiogram normal', 'Swelling face', 'Troponin I normal']",2,MODERNA,SC 997553,VA,92.0,M,"fatigue x 5 days, including day of vaccination, death the night of day 5/early morning of day 6",Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,01/26/2021,02/01/2021,6.0,PVT,"nexium, isosorbide, metoprolol, norvasc, lipitor, trospium; baby asa, paracalcitrol, vitamin b, mutli vitamin, sodium bicarbonate, tums prn, vit d3, mealatonin prn, pepcid, nitrostat prn, ativan prn",none,"hypertension, CAD, CRF, hyperlipidemia",,"isoniazid, diltiazem,versed","['Death', 'Fatigue']",1,PFIZER\BIONTECH,IM 997571,TX,93.0,F,BRAIN BLEED,Yes,01/15/2021,Not Reported,Yes,,Not Reported,N,01/06/2021,01/07/2021,1.0,SEN,,,,,,['Cerebral haemorrhage'],1,PFIZER\BIONTECH,IM 997581,,84.0,F,"The next morning after the vaccine she reports multiple episodes of emesis and feeling ""crappy""",Not Reported,,Not Reported,Yes,,Not Reported,,01/27/2021,01/28/2021,1.0,UNK,,,,,,"['Feeling abnormal', 'Vomiting']",UNK,PFIZER\BIONTECH, 997584,TX,98.0,M,"STROKE, ABDOMINAL ANEURYSM, FATIGUE, VOMITING, FALL, HEADACHE, BODY ACHE",Not Reported,,Yes,Yes,,Not Reported,N,01/27/2021,01/28/2021,1.0,SEN,,,,,,"['Aortic aneurysm', 'Cerebrovascular accident', 'Fall', 'Fatigue', 'Headache', 'Pain', 'Vomiting']",2,PFIZER\BIONTECH,IM 997595,TX,76.0,F,"SHORTNESS OF BREATH, LOW O2 STATS",Not Reported,,Not Reported,Yes,,Not Reported,N,01/06/2021,01/07/2021,1.0,SEN,,,,,,"['Dyspnoea', 'Oxygen saturation decreased']",1,PFIZER\BIONTECH,IM 997613,OH,58.0,M,"Patient is a 58-year-old male with above-mentioned comorbidities presented with feeling hot and faint. Patient was found to have A. fib with RVR which was new onset received IV Cardizem. Patient was kept on telemetry serial cardiac enzymes were negative for acute coronary syndrome. Echo done showed an ejection fraction of 58%. Cardiology evaluation was done by Dr. Cardiology did not recommend any long-term anticoagulation, recommended outpatient follow-up and possible Holter monitor. Patient reverted to normal sinus rhythm) clinically stable. Patient was cleared for discharge per cardiology.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/03/2021,02/03/2021,0.0,PVT,,NONE,,,PN,"['Atrial fibrillation', 'Cardiac telemetry normal', 'Dizziness', 'Echocardiogram', 'Ejection fraction normal', 'Feeling hot', 'Myocardial necrosis marker normal']",2,MODERNA,IM 997642,MT,62.0,F,We were notified 02/02/2021 of patient's death. Unknown cause at this time.,Yes,02/02/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,02/02/2021,14.0,PUB,unknown,"possible blood clots, not disclosed at time of vaccination",chronic back pain,,vibramyacin,['Death'],1,MODERNA,IM 997677,WI,94.0,F,"Rapid decline in health status, Elevated BP&P, posturing, loss of consciousness, Glasgow coma Scale 4 starting 2/1/2021, Deceased 2/3/21",Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,PHM,"Losartan, dilTIAZem, Omeprazole, Ipratropium-Albuterol Solution, Perforomist Nebulization Solution, Furosemide, Budesonide Suspension, Levothyroxine , PARoxetine, Melatonin, Ibuprofen, Aspirin, Cholecalciferol, Docusate Sodium Capsule, ARIP",,"PULMONARY FIBROSIS, CHRONIC RESPIRATORY FAILURE WITH HYPOXIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HYPOTHYROIDISM, HYPERTENSION, IRON DEFICIENCY ANEMIAS",,"Amlodipine, Ciprofloxacin, Citalopram, Codeine, Penicillin, traMADol, Spiriva Respimat, Sulfa Antibiotics","['Blood pressure increased', 'Cerebrovascular accident', 'Coma scale abnormal', 'Death', 'General physical health deterioration', 'Heart rate increased', 'Loss of consciousness', 'Posturing', 'Pulmonary embolism']",1,MODERNA,IM 997687,MA,41.0,F,"On 1/30/2021, I developed a mild headache followed by an acute change in my vision. I went to the emergency room 24 hours later after the symptoms had not resolved and was found to have a left superior quadrantanopia and a 2.3cm x 1.9cm hemorrhage in my right occipital lobe. I was admitted to hopsital and discharged today 2/3/2021. My headache has resolved but I continue to have a visual field deficit. I had been scheduled to receive the second dose of Moderna on 2/1/2021 but was unable to receive it due to my hospitalization.",Not Reported,,Not Reported,Yes,3.0,Yes,N,01/03/2021,01/30/2021,27.0,PVT,none,none,none,,none,"['Angiogram cerebral normal', 'Blood cholesterol increased', 'Cerebral haemorrhage', 'Headache', 'Laboratory test abnormal', 'Magnetic resonance imaging brain abnormal', 'Quadrantanopia', 'Visual field defect', 'Visual impairment']",1,MODERNA,IM 997693,NY,55.0,F,"Received 2nd vaccine on 1/14/21 on 1/15/21 was sick with flu like symptoms and pain in both legs for 5 days was seen by doctor who did covid test came back negative. After 5 days flu like symptoms some what resolved but leg pain continued. Hard to walk and painful. Seen doctors 2 more times when they finally did bloodwork and sent her for admission to hospital. They have done Bloodwork, MRI's and they are all coming back normal but still have leg pain, cant bend toes or touch leg. Been out of work since.",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,01/14/2021,01/15/2021,1.0,PVT,none,none,none,,,"['Blood test normal', 'Gait disturbance', 'Illness', 'Impaired work ability', 'Influenza like illness', 'Magnetic resonance imaging normal', 'Pain', 'Pain in extremity', 'SARS-CoV-2 test negative', 'Tenderness']",2,PFIZER\BIONTECH,IM 997740,OH,59.0,F,"45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilating, increased B/P 200+/130+, decreased Responsiveness, tunnel vision, pin point pupils and no response to verbal and tactile cues For about 10 minutes. Transported to Hospital. Have Residual HTN.",Not Reported,,Not Reported,Yes,,Yes,U,01/07/2021,01/07/2021,0.0,PVT,"Prozac, ImitRex PRN",None,"Depression, Migranes (controlled with Excedrin Migraine)",,,"['Blood pressure increased', 'Computerised tomogram head normal', 'Dizziness', 'Hypertension', 'Hyperventilation', 'Magnetic resonance imaging brain normal', 'Miosis', 'Nausea', 'Tunnel vision', 'Unresponsive to stimuli', 'Vomiting']",1,PFIZER\BIONTECH, 997743,KS,50.0,M,"Client phoned with concerns of chest tightness and ""just didn't feel right."" Client has past med hx of a MI. Nurse was unable to establish date of previous MI",Not Reported,,Not Reported,Yes,,Not Reported,U,02/01/2021,02/01/2021,0.0,PUB,,none,Hx - Heart attack,,,"['Chest discomfort', 'Feeling abnormal', 'Stent placement']",1,MODERNA,IM 997783,OH,65.0,M,patient passed away subsequent to receiving dose on 02/01. Staff does not have reason to believe vaccine was involved.,Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/03/2021,2.0,SEN,unknown,unknown,"pt lived in long term care facility, unknown health conditions",,none known,['Death'],2,PFIZER\BIONTECH,IM 997798,,80.0,M,COPD exacerbation; SOB (shortness of breath); Shortness of breath; Suspected COVID-19 virus infection,Not Reported,,Not Reported,Yes,,Not Reported,N,01/31/2021,02/01/2021,1.0,UNK,,,,,,"['COVID-19', 'Chronic obstructive pulmonary disease', 'Dyspnoea']",2,PFIZER\BIONTECH, 997830,,79.0,M,"Chest pain; Chest pain; Chest pain, unspecified type; Pleural effusion on left",Not Reported,,Not Reported,Yes,,Not Reported,N,01/31/2021,02/01/2021,1.0,UNK,,,,,,"['Chest pain', 'Pleural effusion']",2,PFIZER\BIONTECH, 997856,,91.0,F,"Chest pain; Dehydration; Elevated troponin; Encephalopathy, metabolic; Hypernatremia; Troponin I above reference range; Uremia; Weak; Weakness",Not Reported,,Not Reported,Yes,,Not Reported,N,01/31/2021,02/01/2021,1.0,UNK,,,,,,"['Asthenia', 'Azotaemia', 'Chest pain', 'Dehydration', 'Hypernatraemia', 'Metabolic disorder', 'Metabolic encephalopathy', 'Troponin I increased']",2,PFIZER\BIONTECH, 997877,,90.0,M,"AS (aortic stenosis); Cardiac syncope; Pancytopenia; Severe aortic valve stenosis; Symptomatic anemia; Syncope; Syncope, unspecified syncope type",Not Reported,,Not Reported,Yes,,Not Reported,,01/31/2021,02/01/2021,1.0,UNK,,,,,,"['Anaemia', 'Aortic stenosis', 'Aortic valve stenosis', 'Pancytopenia', 'Syncope']",2,PFIZER\BIONTECH, 997909,,66.0,M,"Headache, Mylagia, Chills Narrative:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/26/2021,1.0,OTH,,,,"yes-reported chills, body aches age-65, after 1st vaccination- December 28, 2020- Moderna",,"['Chills', 'Headache', 'Myalgia']",2,MODERNA,IM 997911,,74.0,M,"Narrative: Patient received Moderna COVID-19 vaccine via drive thru clinic. The patient was in his vehicle with his wife, when he became diaphoretic and passed out for a couple minutes. Rapid response was called. Patient was removed from the vehicle. He was becoming obtunded and was placed on the pavement. 911 was called. He was given EpiPen at 10:41. His vital signs at 1042 were: saturation 98% on room air, pulse 59, blood pressure 138/80. Patient received Solu-Medrol 125 mg IM a couple of minutes after EpiPen. After the EpiPen the patient became more alert, denied shortness of breath or wheezing, he was nauseated without vomiting. His saturation at that point dropped to 88% on room air, he was started on oxygen with nonrebreather mask. Rescue truck arrived at approximately 1047, and the patient was taken to emergency room. Discharged same day.",Not Reported,,Yes,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,OTH,,,,,,"['Depressed level of consciousness', 'Hyperhidrosis', 'Loss of consciousness', 'Nausea']",1,MODERNA,IM 997912,,83.0,M,"Narrative: Patient is 82 years old with cardiovascular disease and fell when bending over to pick something up. Therefore, it is not clear if fall was caused by these risk factors or by the vaccine. However, he had complained of weakness prior to this episode.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/28/2021,01/29/2021,1.0,OTH,,,,,,"['Asthenia', 'Fall']",1,MODERNA,IM 997967,PA,45.0,F,"Pt. presented for her second dose of Covid vaccine and denied having reaction to her first dose. Pt. was vaccinated at 7:22 am and was checked on at 7:45 am, when she indicated a tightness in her chest and throat. First response was called and at 7:48 Benadryl 25mg IM was given and at 7:50 a dose of epi 0.3 sq was provided and pt. was transfered to the ED by Wheelchair. Presented in ED essentially asymptomatic by time she arrived to ED per ED physician. She was given 10 mg Dexamethasone 10 mg IV, Benadryl 50 mg IV, Famotidine 20 Mg IV in the ED. Pt. discharged from ED at 10:42 am the same day. After discharge on 1/29/2021, the patient continued to have symptoms. On 2/2/21 12:44 pm called Covid Medical Command c/o 8/10 mid sternal CP radiating to her back. Also complaining of chest heaviness, advised by Dr. to seek care at the ED. Pt. arrived at the ED at 13:02 and was being worked up for chest pain worsening when taking deep breaths. The pain started yesterday and was worsened at work. Also c/o felling fatigue and chills. Pt. given keteolorac 30mg and Lidocaine patch. Additional pain medication of morphine was given. Worked up for PE with CT of chest. R/O ACS in the ED. CP was found to be reproducible and she was diagnosed with chest wall pain. Still has chest discomfort 2/3/21, but feels able to return to work.",Not Reported,,Yes,Not Reported,,Not Reported,,01/29/2021,01/29/2021,0.0,PVT,"singulair, propanolol, clonazepam PRN, Topamax, prazosin, duloxetine, Trazodone, Omeprazole",Appendectomy,"Fibromyalgia, Endometriosis, Anxiety, adjustment disorder, MDD, PTSD,",,"Ciprofloxacin, Clarithromycin, Doxycycline, Metoclopramide, Additional allergies: Oycodone, Pregabalin, Tetracyclines, Gabapentin, Levoflozacin, Pravastatin, Bactrim, Baclofen, Dicloxacillin,","['Activated partial thromboplastin time normal', 'Back pain', 'Brain natriuretic peptide normal', 'Chest X-ray normal', 'Chest discomfort', 'Computerised tomogram thorax', 'Electrocardiogram normal', 'Fatigue', 'Full blood count normal', 'International normalised ratio normal', 'Metabolic function test', 'Metabolic function test normal', 'Prothrombin level normal', 'Throat tightness', 'Troponin normal', 'Wheelchair user']",2,MODERNA,IM 997973,CA,73.0,F,"Received vaccine at 1100 on 1/29/21. No symptoms noted during 30 minute post-vaccine observation period. Symptom onset at 0300 on 1/30/21 (16 hours after vaccine administration). Symptoms included chest pain, dyspnea on exertion, weakness, nausea/vomiting, decreased appetite, and diarrhea. Patient presented to Medical Center Emergency Department around 1130 on 2/1/21. Found to have NSTEMI 2/2 Takotsubo's cardiomyopathy with acute congestive heart failure. (of note, coronary angiography in 11/20 showed no coronary artery disease). Patient has never had a reaction to a vaccine or component despite receiving many vaccines due to extensive travel history.",Not Reported,,Yes,Yes,,Not Reported,N,01/29/2021,01/30/2021,1.0,PVT,Aspirin 81 mg daily Diltiazem 240 mg daily Hydroxychloroquine 400 mg Pravastatin 10 mg daily Pepcid 40 mg daily,None,Stage 4 CKD Hepatocellular carcinoma without metastases s/p resection Seronegative RA Viral pericarditis in 2018 HTN GERD Asthma,,Augmentin (anaphylaxis) Penicillin G (anaphylaxis) Hydrochlorothiazide (rash) Cimetidine (hives) Bactrim (hives) Nitrofurantoin Sulfanomides (hives) Amlodipine (swelling),"['Activated partial thromboplastin time', 'Acute myocardial infarction', 'Asthenia', 'Blood creatine phosphokinase MB', 'Blood lactic acid', 'Blood thyroid stimulating hormone', 'Cardiac failure acute', 'Cardiac failure congestive', 'Chest pain', 'Congestive cardiomyopathy', 'Decreased appetite', 'Diarrhoea', 'Dyspnoea', 'Dyspnoea exertional', 'Echocardiogram', 'Electrocardiogram', 'Full blood count', 'Glycosylated haemoglobin', 'Lipids', 'Metabolic function test', 'N-terminal prohormone brain natriuretic peptide', 'Nausea', 'Procalcitonin', 'Prothrombin time', 'SARS-CoV-2 test', 'Stress cardiomyopathy', 'Troponin T', 'Vomiting']",1,MODERNA,IM 997975,FL,33.0,F,"elevated temp, flushed face, shaking, c/o being cold, shivering- assessed by physician and transferred to ER",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/20/2021,01/20/2021,0.0,OTH,"Eloquis, calcium/VitD, zyrtec,thoarazine, colace, pepcid, haldol dec, synthroid, lisinopril, lorazapam, magnesium, zyprexa, ditropan XL, mirilax, depakene, tylenol,",,"obesity, asthma, gastritis, constipation, hypertension, metabolic syndrome, chronic UTI, Breast nodule, hypothyroidism, rectal bleeding, abnormal EKG",,NKA,"['Body temperature increased', 'Chest X-ray', 'Chills', 'Computerised tomogram thorax', 'Flushing', 'HIV test', 'Influenza virus test', 'Magnetic resonance imaging brain', 'Nasopharyngitis', 'SARS-CoV-2 test', 'Tremor', 'Urine analysis']",1,MODERNA,IM 998000,MA,40.0,F,"Ten minutes after vaccine became dizzy, diaphoretic, tachycardiac and hypertensive. Felt better went home started vomiting With dizziness. Went to ER. Admitted for 3 days. Still suffering from dizziness and under care of ENT doctor being treated now for BPPV",Not Reported,,Not Reported,Yes,3.0,Not Reported,,01/20/2021,01/20/2021,0.0,PVT,,,,,,"['Dizziness', 'Hyperhidrosis', 'Hypertension', 'Tachycardia', 'Vertigo positional', 'Vomiting']",2,MODERNA,IM 998009,NJ,44.0,F,Patient admitted with HSV encephalitis with non-convulsive status epilepticus on 1/30/21,Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/16/2021,01/30/2021,14.0,OTH,none,migraines,none,,none,"['Electroencephalogram abnormal', 'Herpes simplex encephalitis', 'Lumbar puncture abnormal', 'Magnetic resonance imaging abnormal', 'Status epilepticus']",UNK,MODERNA,IM 998062,MI,66.0,M,"Tinnitus and diminished hearing onset 12/27/2020. Symptoms less evident, but still persisting as of the date of report.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/26/2020,12/27/2020,1.0,PVT,"Levothyroxine, atenolol, losartan, rosuvastatin, aspirin, multiple vitamin",None,Coronary artery disease with stable angina; hypertension; hyperlipidemia; hypothyroidism,,"Naproxen, doxycycline, cefazolin, trimethoprim-sulfamethoxazole, lobster, crab","['Hypoacusis', 'Tinnitus']",1,PFIZER\BIONTECH,IM 998063,CA,63.0,M,Does not know any other information. Patient is her father in law. The day of receiving the vaccine he started to feel fatigued. Before receiving the vaccine patient was fine. Patient ended up passing away either the 1st or 2nd. Medical examiner told reporter that she believes it was the vaccine that caused the patient's death.,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,,01/25/2021,01/25/2021,0.0,SEN,,,Diabetes and High Blood pressure,,,"['Death', 'Fatigue']",UNK,UNKNOWN MANUFACTURER, 998079,,90.0,M,"Abnormal chest x-ray; Altered mental status, unspecified altered mental status type; Arrhythmia; Bradycardia; CHF (congestive heart failure); Cardiac arrhythmia, unspecified cardiac arrhythmia type; Essential hypertension; Heart failure with preserved ejection fraction, unspecified HF chronicity; Hypothermia, initial encounter; Pneumonia of right middle lobe due to infectious organism; Right middle lobe pneumonia",Not Reported,,Not Reported,Yes,,Not Reported,N,01/31/2021,02/01/2021,1.0,UNK,,,,,,"['Arrhythmia', 'Bradycardia', 'Cardiac failure', 'Cardiac failure chronic', 'Chest X-ray abnormal', 'Essential hypertension', 'Hypothermia', 'Infection', 'Mental status changes', 'Pneumonia']",2,PFIZER\BIONTECH, 998108,,74.0,M,"Acute on chronic systolic heart failure; Atrial fibrillation with RVR; CHF (congestive heart failure); Essential hypertension; Hyperlipidemia, unspecified hyperlipidemia type; NSTEMI (non-ST elevated myocardial infarction); New onset a-fib",Not Reported,,Not Reported,Yes,,Not Reported,N,01/31/2021,02/01/2021,1.0,UNK,,,,,,"['Acute left ventricular failure', 'Acute myocardial infarction', 'Atrial fibrillation', 'Cardiac failure congestive', 'Chronic left ventricular failure', 'Essential hypertension', 'Hyperlipidaemia']",2,PFIZER\BIONTECH, 998123,AZ,79.0,F,Severe vertigo; pressure in the ears; eye nystagmus drastically worsened; Strong intense pressure in the head (not a headache); Fatigue,Not Reported,,Not Reported,Not Reported,,Yes,N,01/28/2021,01/29/2021,1.0,OTH,Gabapentine; Losartin; Atorvastatin; B Complex; Multi-vitamin,None,Ataxia caused by Spinal Cerebellar Atrophy,,Sulfa,"['Ear discomfort', 'Fatigue', 'Head discomfort', 'Nystagmus', 'Vertigo']",1,PFIZER\BIONTECH,IM 998138,FL,86.0,F,"Same day as vaccination given, developed pain went from arm up to shoulder, to back, to neck to head - right side of body; chills/body aches",Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,SEN,Daughter unaware of prescriptions,Was hospitalized in December for testing positive for COVID 12/18/2020 - hospitalized for 4 days then released back to nursing home facility.,Type 2 diabetes; high blood pressure,,No known allergies,"['Arthralgia', 'Back pain', 'Chills', 'Headache', 'Neck pain', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 998152,VA,78.0,M,"Patient presented to hospital with 1 day of extreme lethargy 2 days after receiving the Moderna COVId-19 vaccine. Patient had Mohs surgery on a L forearm lesion with cryotherapy to scalp on 27 Jan. He went to daycare problem on 28 Jan, in normal state of health. upon return, patient felt warm and had difficulty standing out of car. Wife let him rest on a chair in the kitchen and found him on the floor in the morning, for a unknown amount of time, unwitnessed descent to floor.",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/26/2021,01/28/2021,2.0,MIL,Gabapentin 900 mg in morning and 600 mg at bedtime Memantine 10 mg twice a day Citalopram 10 mg daily Mirabegron 50 mg daily Tamsulosin 0.4 mg daily Atorvastatin 40 mg daily Galantamine HBr 8 mg,Patient had mohs surgery on a L forearm lesion with cryotherapy to scalp on 27 Jan 2021,Dementia HTN HLC BCC Bladder stones UTI in April 2020,,No allergies,"['Dysstasia', 'Fall', 'Feeling hot', 'Lethargy']",UNK,MODERNA,IM 998175,NH,84.0,F,Resident vaccinated-1/7/21 Resident covid positive 1/11/21 Resident covid PNA-1/12/21 Resident hospitalized 1/16/21 Resident deceased 1/20/21,Yes,01/20/2021,Not Reported,Yes,6.0,Not Reported,N,01/07/2021,01/16/2021,9.0,SEN,Metoprolol succinate ER tab ER 24hr 100mg PO daily Milk of Magnesia Suspension 400mg/5l 30ml PRN Mirtazapine 45mg tab at bedtime Clonazepam tab 0.5mg BID D-Mannose Capsule 500 MG 1 capsule daily Cranberry Tablet 450 MG 1 tablet twice daily,No,"MAJOR DEPRESSIVE DISORDER, RECURRENT, SEVERE WITH PSYCHOTIC SYMPTOMS UNSPECIFIED PSYCHOSIS NOT DUE TO A SUBSTANCE OR KNOWN PHYSIOLOGICAL CONDITION MILD COGNITIVE IMPAIRMENT, SO STATED GENERALIZED ANXIETY DISORDER ESSENTIAL (PRIMARY) HYPERTENSION TYPE 2 DIABETES MELLITUS WITHOUT COMPLICATIONS AGE-RELATED OSTEOPOROSIS WITHOUT CURRENT PATHOLOGICAL FRACTURE OTHER ALLERGIC RHINITIS OTHER IRRITABLE BOWEL SYNDROME PNEUMONIA DUE TO CORONAVIRUS DISEASE 2019 COVID-19 BACTERIAL INTESTINAL INFECTION, UNSPECIFIED HYPOKALEMIA UNSPECIFIED SYMPTOMS AND SIGNS INVOLVING COGNITIVE FUNCTIONS AND AWARENESS OTHER SEBORRHEIC KERATOSIS HYPERLIPIDEMIA, UNSPECIFIED AGORAPHOBIA WITH PANIC DISORDER PRESENCE OF RIGHT ARTIFICIAL HIP JOINT ACQUIRED ABSENCE OF BOTH CERVIX AND UTERUS ACQUIRED ABSENCE OF OTHER ORGANS CYST OF KIDNEY, ACQUIRED NEOPLASM OF UNCERTAIN BEHAVIOR OF LIVER, GALLBLADDER AND BILE DUCTS OTHER SLEEP DISORDERS PURE HYPERGLYCERIDEMIA SPONDYLOSIS WITHOUT MYELOPATHY OR RADICULOPATHY, SITE UNSPECIFIED",,"Penicillin, Pravastatin","['COVID-19', 'COVID-19 pneumonia', 'Death', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 998181,TX,50.0,F,"On February 2 I went to the ED with an appendicitis, had to have an appendectomy. I did have significant symptoms the day after the vaccine. HA, nausea, dizziness. The nausea never resolved prior to going to the ED 5 days after the 2 vaccination",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/27/2021,01/31/2021,4.0,PHM,estrogen and progesterone for hormone replacement post-menopause,none,No chronic medical issues,,clindamycin,"['Appendicectomy', 'Appendicitis', 'Computerised tomogram abnormal', 'Dizziness', 'Headache', 'Nausea']",UNK,MODERNA, 998224,IL,28.0,F,"Anaphylaxis. Epi Pen given and ambulance called. Given anaphylaxis cocktail in ER. 2:30pm: Vaccine administered 3:30pm: Headache & teeth ache which continued 7:00pm asthmatic cough which continued throughout 11:00pm fever and chills 9:00am felt generally very ill--stomach pain (more anaphylactic type pain) 10:00am nausea, severe stomach pain, diarreaha, vomiting, lungs very tight, continued coughing 11:00am excruciating stomach pain (stomach on fire) Throat felt ""thick"", feeling faint, brain fog, dizzy (These are my typical anaphylactic reactions) Epi pen administered & ambulance called Anaphylaxis symptoms returned in ER. The pain was the worst since my bowel obstructions several years ago.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,PVT,synthroid vitamin D claritin iron supplement montelukast clindamiacin topical lexapro prazosin lamictal,none,mast cell activation syndrome oral allergy syndrome Hashimoto's thyroiditis hydradenitis supperativa psoriasis/ eczema depression/anxiety,,"Food: banana, kiwi, avocado, strawberry, sesame, hazelnut, macadamia nuts, Drugs: biaxin","['Abdominal pain upper', 'Anaphylactic reaction', 'Asthma', 'Chest discomfort', 'Chills', 'Cough', 'Diarrhoea', 'Dizziness', 'Dyspnoea', 'Feeling abnormal', 'Headache', 'Malaise', 'Nausea', 'Pyrexia', 'Throat tightness', 'Toothache', 'Vomiting']",1,MODERNA,IM 998228,MI,65.0,M,Found unresponsive,Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/03/2021,5.0,OTH,ALBUTEROL HFA (8.5GM) 90 MCG INHA TAKE 1-2 PUFFS INHALATION EVERY 4 TO 6 HOURS AS NEEDED APAP 325MG TABS one (1) to two (2) tabs By Mouth two times daily as needed CALCIUM CARB (150) 500 MG CHEW TAKE 1-2 TABS BY MOUTH THREE TIMES DAILY AS,COPD Gastro-espohageal reflux Osteoarthritis Essential Hypertension Dermatitis COVID-19,,,NONE,['Unresponsive to stimuli'],1,MODERNA,IM 998242,NY,61.0,F,"Sudden total hearing loss, left ear; numbness in face and outer ear.",Not Reported,,Not Reported,Not Reported,,Yes,U,01/23/2021,01/24/2021,1.0,UNK,"Vitamins D, C, Zinc, Tumeric Valsartan (blood pressure)",none,High blood pressure,,augmentin,"['Acoustic stimulation tests abnormal', 'Audiogram', 'Blood test', 'Deafness', 'Hypoaesthesia', 'Magnetic resonance imaging', 'Magnetic resonance imaging brain', 'Sudden hearing loss']",1,PFIZER\BIONTECH,IM 998245,IL,36.0,F,"On Saturday had nausea, vomiting started, and progressively lead to dizziness, shortness of breath, chest tightness, diarrhea, feeling of something stuck in her throat globus sensation, weakness. She went to the ER on 1/18/21 they felt she had gastritis and gave her fluids, Zofran and COVID test which was negative, then they sent her home. It continued where she could not eat, could not sleep, felt like she was going to die. She ended up going back to the ER again on 1/23/21. They did a CT scan, EKG, gave her IV fluids, flu and an antimotility agent for the nausea. They did lab work to rule out other tests. Did stool culture, blood work. She got admitted over night, then she had endoscopy on 1/24/21 to rule out any issues with her throat since she felt like it was closing on her. They said her esophagus looked fine, took biopsies. All the tests that were done were negative, and sent her home on 1/24/21. Then on Monday, 1/25/21 went to see a ENT specialist who also did a scope to loop down her throat to se if anything was blocked and felt that it was inflammation due to vomiting. Advised to take Proton pump inhibitor to help with the acid reflux from the vomiting. The GI doctor called on 1/26/21 showed some H-pylori, but did not know why she had that. Was started on antibiotics for that. She saw her PCP on 1/28/21, who did work up for celiac disease, thyroid scan/studies and all tests were negative as well. Right now she is home and the plan is to wait it out and to see if she gets better over time. She still having today 2/3/21 diarrhea, no appetite, cannot sleep, occasional chills, no fever, headache, chest tightness, nausea but is taking Zofran, still having the globus sensation in her throat. States her ""body is not well"", weakness as well.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/13/2021,01/16/2021,3.0,PVT,None.,None.,None.,,None.,"['Asthenia', 'Biopsy oesophagus normal', 'Blood test normal', 'Chest discomfort', 'Chills', 'Computerised tomogram normal', 'Culture stool', 'Decreased appetite', 'Diarrhoea', 'Dizziness', 'Dyspnoea', 'Electrocardiogram normal', 'Endoscopy', 'Fear', 'Feeding disorder', 'Gastritis', 'Gastrooesophageal reflux disease', 'Helicobacter infection', 'Helicobacter test positive', 'Inflammation', 'Insomnia', 'Malaise', 'Nausea', 'Pharyngeal swelling', 'SARS-CoV-2 test negative', 'Scan thyroid gland', 'Sensation of foreign body', 'Throat tightness', 'Vomiting']",2,PFIZER\BIONTECH,IM 998275,NY,52.0,F,"It started with a fever of 99.8 (norm is 97.4). I had brain fog. really slow thoughts. I felt like my brain was in slow motion. Big time fatigue. I felt like I was carrying a truck. I also noticed with my MS I am wobbly but I can catch myself but I felt like it was getting much worse. I called my Dr. and she thinks that the vaccine caused a flare-up in my MS. She gave me a prednisone pack. the last dose of prednisone I took, I was still fatigued. I began using a walker because I couldn't walk safely. I noticed as I tried to get out of my car a few days later I was thrown backwards which caused me to land on my glasses which cut my face and resulted in stitches. I did test but my MS was not in an active flare but they said it could be in a flare because of the COVID vaccine. they couldn't give me medication because that medication causes heart spasms. I was denied by my insurance to go to rehab. I cant walk and I am currently in the hospital.",Not Reported,,Not Reported,Yes,7.0,Not Reported,N,12/31/2020,02/02/2021,33.0,PVT,Ocrevus 600mg Every 6 months Vitamin D3 5000IU daily Escitalopram 10mg daily Senna Laxative 8.5 Daily Myrbetriq 50mg daily Dalfamtridine ER 10mg every 2 hours Magnesium 500mg daily Montelukast 10 mg daily,MS,MS and asthma,Flu Shot,Penicillin Shellfish Flu shot,"['Balance disorder', 'Bradyphrenia', 'Condition aggravated', 'Corrective lens user', 'Discomfort', 'Fall', 'Fatigue', 'Feeling abnormal', 'Multiple sclerosis', 'Pyrexia', 'Skin laceration', 'Suture insertion', 'Thinking abnormal', 'Walking aid user']",1,MODERNA,SYR 998291,AZ,24.0,F,"Pericarditis. Burning and stabbing pain in chest, pain shot down into left arm. Lasted days.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/28/2021,01/30/2021,2.0,PUB,Copper IUD,None,Asthma Poly cystic ovary syndrome,,None,"['Chest pain', 'Pain in extremity', 'Pericarditis']",2,MODERNA,IM 998300,IA,54.0,F,"Developed headache, fever and cough on 1/25 unable to come to work 1/26 and 1/17. Saw provider 1/28 was admitted to hospital with fever, pneumonia, dehydration, elevated d-dimer, headache and cough. Given IV fluids, antibiotics, steroids and nebulizers. Discharged home 1/30/2021.",Not Reported,,Not Reported,Yes,3.0,Not Reported,,01/25/2021,01/26/2021,1.0,UNK,,,,,,"['Cough', 'Dehydration', 'Fibrin D dimer increased', 'Headache', 'Impaired work ability', 'Pneumonia', 'Pyrexia']",2,MODERNA,IM 998386,TX,39.0,M,Bell's Palsy,Not Reported,,Not Reported,Not Reported,,Yes,N,01/15/2021,02/02/2021,18.0,OTH,Lamaodil,,Non alcoholic Fatty liver disease,,Tramadol,['Facial paralysis'],UNK,MODERNA, 998412,NJ,54.0,M,"Patient is noticed to have generalized weakness, holding his head towards right side, mild right facial puffiness with mild left facial droop, and sent to ER, on 1/22/21. Patient also had mild fever for the last two days and was on Tylenol, blood pressure also remained elevated moderately than the usual readings. Patient was admitted through ER for 2 days and was discharged on 1/24/21, with a diagnosis of possible TIA, Todd's paresis post seizure. Patient's CT head and MRI of brain was negative for acute stroke. Patient's left facial droop and right side facial puffiness resolved over a week but noticed to have right sided pronounced weakness with moderate swelling on right arm. Patient used to eat by himself,but now not able to do so and not able to hold cup in the right hand. Patient was again sent to ER for repeat CAT scan of head, further evaluation and management. Not sure if patient had an adverse reaction to Covid-19 vaccination, but definitely these symptoms were developed after 2 weeks of receiving Pfizer vaccination, which may be coincidental. Patient was followed up by the neurologist a week after the discharge from hospital who couldn't rule out adverse reaction of vaccination. Patient is awaiting for an EEG, carotid ultrasound and Echo as an out patient.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/08/2021,01/20/2021,12.0,SEN,Yes,None other than the chronic conditions,"Hypertension, DM-2, Impulse Control Disorder, Autism Spectrum Disorder, Insomnia, Osteoporosis, Gastritis",,"Dust, Milk, pollen extracts and Strawberry","['Asthenia', 'Blood pressure increased', 'Computerised tomogram head', 'Facial paralysis', 'Feeding disorder', 'Full blood count', 'Hemiparesis', 'Magnetic resonance imaging brain', 'Metabolic function test', 'Paresis', 'Peripheral swelling', 'Posture abnormal', 'Pyrexia', 'Seizure', 'Swelling face']",1,PFIZER\BIONTECH,IM 998416,ND,39.0,F,"Two tonic clonic seizures experienced 6&12 hours post chemotherapy (4 days post vaccine) regimen, cycle 2 of adriamycin and cytoxan",Not Reported,,Not Reported,Yes,1.0,Yes,Y,01/08/2021,01/12/2021,4.0,PVT,Doxorubicin Cyclophosphamide Dexamethasone Metoclopramide Ondansetron Peg filgrastim Aloxi Emend Lorazepam Doxylamine Vitamin B1 Famotidine,"Breast cancer, stage 3. HER2 negative",Anxiety,,Penicillin Steri strips Medical adhesive,"['Computerised tomogram head normal', 'Electroencephalogram normal', 'Full blood count normal', 'Generalised tonic-clonic seizure', 'Magnetic resonance imaging brain normal', 'Metabolic function test normal']",2,PFIZER\BIONTECH,IM 998419,NH,76.0,F,Resident vaccinated-1/8 Resident deceased-1/16,Yes,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/16/2021,8.0,SEN,Artificial Tears Solution 0.4 % (Hypromellose) Instill 1 drop in both eyes as needed for dry eyes QID Aspirin Tablet 81 MG Give 1 tablet by mouth one time a day Lasix Tablet 40 MG (Furosemide) Give 1 tablet by mouth one time a day for CHF T,See below,"HEART FAILURE, UNSPECIFIED TYPE 2 DIABETES MELLITUS WITH DIABETIC NEUROPATHY, UNSPECIFIED NTA (2 pts) ANXIETY DISORDER, UNSPECIFIED BORDERLINE PERSONALITY DISORDER ESSENTIAL (PRIMARY) HYPERTENSION LEGAL BLINDNESS, AS DEFINED IN USA MAJOR DEPRESSIVE DISORDER, SINGLE EPISODE, UNSPECIFIED UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE PERSONAL HISTORY OF COVID-19 DYSPHAGIA, OROPHARYNGEAL PHASE PNEUMONIA, UNSPECIFIED ORGANISM TINEA UNGUIUM ONYCHOGRYPHOSIS UNSPECIFIED OPEN-ANGLE GLAUCOMA, INDETERMINATE STAGE UNSPECIFIED PSYCHOSIS NOT DUE TO A SUBSTANCE OR KNOWN PHYSIOLOGICAL CONDITION CHONDROCOSTAL JUNCTION SYNDROME [TIETZE] DEPENDENCE ON SUPPLEMENTAL OXYGEN UNSPECIFIED SEQUELAE OF UNSPECIFIED CEREBROVASCULAR DISEASE SLP OTHER SYMBOLIC DYSFUNCTIONS EDEMA, UNSPECIFIED HYPERLIPIDEMIA, UNSPECIFIED IRON DEFICIENCY ANEMIA, UNSPECIFIED ANEMIA, UNSPECIFIED PERSONAL HISTORY OF OTHER VENOUS THROMBOSIS AND EMBOLISM CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED",,"Brimonidine, Metformin, Bactrim, tape",['Death'],1,PFIZER\BIONTECH,IM 998421,NC,91.0,M,Resident passed away unexpectedly on 1/27/21 from presumed sudden cardiac death.,Yes,01/27/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/27/2021,21.0,SEN,acetaminophen aspirin- 81mg calcium carbonate carbidopa-levodopa cholecalciferol fenofibrate fluorouracil cream fluticasone nasal spray folic acid nitroglycerin PRN miralax,Basal cell carcinoma of right ear,Parkinson's CAD Labile HTN Renal artery stenosis HLD Basal cell carcinoma Squamous cell carcinoma BPH Prostate CA Urge incontinence Mild cognitive impairment,,Verapamil Amlodipine Morphine Penicillins,"['Death', 'Sudden cardiac death']",1,MODERNA,IM 998422,TX,84.0,M,"patient developed progressive diffuse muscle weakness, altered mental status including excessive drowsiness, decreased oral intake starting on 1/31/2021. Symptoms continued to worsen overnight and he was evaluated in the emergency room on 2/2/2021 and admitted with dehydration and altered mental status. He was aggressively hydrated overnight, but showed persistent diffuse muscle weakness, altered mental status with decreased responsiveness progressing, but no focal neurological findings noted. CT scan of the head on 3/3/2021 showed no findings other than age-related diffuse cerebral atrophy. The patient did spike a fever to 103 on the morning of 2/3/2021. CBC, CMP, procalcitonin and lactic acid levels remained normal. He remains hospitalized in stable condition as of 2/3/2021 @1300.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/30/2021,01/31/2021,1.0,PVT,Amlodipine 5 mg daily; cimetidine 300 mg 4 times a day; donepezil 10 mg daily; fluticasone nasal spray daily; gabapentin 600 mg 3 times a day; glipizide 2.5 mg daily; losartan 100 mg daily; memantine10 mg twice a day; metformin 500 mg twice,None,"Type II diabetes, hypertension, hypothyroidism, GERD, hyperlipidemia, early dementia.",,None,"['Alanine aminotransferase normal', 'Aspartate aminotransferase normal', 'Blood albumin', 'Blood alkaline phosphatase normal', 'Blood bilirubin normal', 'Blood calcium', 'Blood chloride normal', 'Blood creatine phosphokinase MB decreased', 'Blood creatine phosphokinase MB increased', 'Blood creatine phosphokinase normal', 'Blood creatinine increased', 'Blood glucose increased', 'Blood lactic acid', 'Blood lactic acid normal', 'Blood potassium normal', 'Blood sodium decreased', 'Blood urea increased', 'Blood urine absent', 'Brain natriuretic peptide normal', 'Carbon dioxide decreased', 'Cerebral atrophy', 'Chest X-ray normal', 'Computerised tomogram head normal', 'Dehydration', 'Full blood count normal', 'Haematocrit normal', 'Haemoglobin decreased', 'Hypophagia', 'Hyporesponsive to stimuli', 'Immunology test', 'Mental status changes', 'Metabolic function test', 'Muscular weakness', 'Platelet count normal', 'Procalcitonin normal', 'Protein urine', 'Pyrexia', 'SARS-CoV-2 test negative', 'Somnolence', 'Specific gravity urine normal', 'Troponin I normal', 'White blood cell count normal', 'pH urine normal']",1,MODERNA,IM 998458,,92.0,M,"Since receiving the COVID-19 vaccine, patient has been sleeping 20 hours a day with decreased oral intake. On 1/30, his mobility began decreasing and he was no longer able to use the walker he normally uses. He is also usually alert and oriented x 4, altered (including hallucinations) when admitted to the ICU on 2/1/21. Also with hypertension and AKI. Management: precedex for agitation, labetalol for hypertension, fluids and foley for AKI",Not Reported,,Not Reported,Yes,,Not Reported,U,01/15/2021,01/15/2021,0.0,UNK,"Apixaban, amiodarone, sinemet, mirtazapine, suvorexant, Breo Ellipta, famotidine, DDAVP, fludrocortisone, levothyroxine, mirabegron, cholecalciferol, cyanocobalamin, folic acid",Increased mirtazapine dose 12/2020.,"Parkinson's dementia, afib, CKD, hypothyroid, hypertension, CAD, HLD, BPH",,"ANTIHISTAMINES, OXYMETAZOLINE, PHEYLEPHRINE, XYLOMETAZOLINE","['Acute kidney injury', 'Agitation', 'Blood creatinine increased', 'Hallucination', 'Hypersomnia', 'Hypertension', 'Hypophagia', 'Intensive care', 'Mental status changes', 'Mobility decreased']",1,PFIZER\BIONTECH,IM 998463,NC,88.0,F,"Resident passed away unexpectedly on 01/19/21 after developing acute hypoxic respiratory failure on morning of 01/19/21. She was transferred to hospital via EMS where she was intubated, coded, and ultimately expired with uncertain underlying cause, potentially ACS.",Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/19/2021,13.0,SEN,acetaminophen amlodipine calcium carbonate + vitamin D3 Celebrex (PRN) Irbesartan lidocaine patch loratadine polyethylene glycol pravastatin,"pneumonia, acute hypoxic respiratory failure","HTN HLD Osteoarthritis osteoporosis impaired mobility secondary to avascular necrosis or right humeral head, and s/p ankle fusions, bilateral knee replacements Sciatica open angle glaucoma",,horse chesnut seed extract,"['Acute coronary syndrome', 'Death', 'Endotracheal intubation', 'Laboratory test', 'Respiratory failure']",1,MODERNA,IM 998532,MD,40.0,F,"The patient was admitted to the hospital on 24 January with chest pain, elevated troponin, and EKG changes in the setting of a couple days of chills, sweats and malaise after receiving the covid vaccine. Initially there was concern for acute MI and he was taken for a coronary angiogram. The angiogram was clean and showed no obstructive disease. He had a cardiac MRI which showed findings consistent with myocarditis. He was treated with supportive care and eventually was discharged. He was worked up for other causes of myocarditis with none to be found.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/21/2021,01/22/2021,1.0,MIL,OTC collagen supplement Ibuprofen prn,none,migraines secondary to a TBI in 2016,,NKDA,"['Antinuclear antibody negative', 'Arteriogram coronary normal', 'Chest pain', 'Chills', 'Coxsackie virus test negative', 'Cytomegalovirus test negative', 'Electrocardiogram abnormal', 'Epstein-Barr virus antibody negative', 'HIV test negative', 'Hyperhidrosis', 'Magnetic resonance imaging heart', 'Malaise', 'Myocarditis', 'SARS-CoV-2 test negative', 'Treponema test negative', 'Troponin increased']",2,PFIZER\BIONTECH,IM 998544,KY,83.0,M,Patient had heart attack. Spoke with spouse on 2/3/2021 stated had multiple health issues including heart and lung issues.,Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/25/2021,12.0,PUB,Multiple medication,"diabetes, heart trouble, dementia",as above,,Morphine and iodine,['Myocardial infarction'],1,MODERNA,IM 998576,WA,86.0,M,"Had acute respiratory failure, dysuria NSTEMI after Dose #1 Lot # 025L20A (Moderna) hospitalized same day 12/31/20 administered @ 1040 back to baseline. 2nd Dose on 1/27/21 0950 Lot as above. Unknown exact onset same day, ED by EMS @ 1745, respiratory distress, febrile 39.4 degrees C BP 150/105 RR 29",Yes,01/31/2021,Not Reported,Yes,,Not Reported,N,01/27/2021,01/27/2021,0.0,SEN,Med List @ time vaccine # 2: PRN acetaminophen Bisacodyl PRN TUMS Clotrimazole Flonase Loratadine Lorazepam Melatonin Bengay Nitrostat Zofran oxycodone Miralax Scheduled: acetaminophen 500 md QID amlodipine 5mg BID Metoprolol 50 mg BID Pra,NSTEMI after COVID vaccine #1,"CAD, CKD4, Hypertension, Anemia, dementia",,"DIPYRIDAMOLE, ERYTHROMYCIN, TERAZOSIN","['Atelectasis', 'Blood creatinine increased', 'Blood culture negative', 'Blood potassium increased', 'Blood urine present', 'Brain natriuretic peptide increased', 'Cardiac telemetry', 'Chest X-ray abnormal', 'Electrocardiogram abnormal', 'Full blood count normal', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Metabolic function test', 'Pleural effusion', 'Protein urine present', 'Pulmonary oedema', 'Pyrexia', 'Respiratory distress', 'SARS-CoV-2 test negative', 'Sinus tachycardia', 'Troponin increased', 'Urine analysis']",2,MODERNA,IM 998579,KY,82.0,M,Resident passed away 2/2/2021.,Yes,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/02/2021,8.0,SEN,Patient is a nursing home resident please notify facility.,Patient is a nursing home resident please notify facility.,Patient is a nursing home resident please notify facility.,,"Iodine, ACE Inhibitors",['Death'],2,PFIZER\BIONTECH,IM 998597,TX,64.0,F,Pt reported chest pressure and pain 1 hour after receiving her 2nd Pfizer vaccine. Negative cardiac work up in emergency department but she has a history of pulmonary embolism so she was admitted to the hospital for observation and further work up with no definitive diagnosis,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/01/2021,02/01/2021,0.0,MIL,,,,,,"['Chest X-ray normal', 'Chest discomfort', 'Chest pain', 'Electrocardiogram normal', 'Myocardial necrosis marker normal']",2,PFIZER\BIONTECH,IM 998598,,98.0,F,"On 1/15/21, resident fell during the night while getting up without assistance and hit her head. She did not have any neurological impairment after fall and remained at facility to be monitored. 1/26/21, resident had sudden loss of consciousness with hypotension and tachycardia. This resolved slowly after resident was put in trendelenberg position. She has not had similar events in the past. She was sent to ED without a distinct underlying cause of the event identified, differential included cardiac arrhythmia, ? orthostatic hypotension, vasovagal syncope, stroke She had a similar event occur on 1/27 after she had returned to the facility from the ED. The family elected not to pursue further evaluation for second event and she was placed on hospice as she had been experiencing some gradual decline before these events occurred.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/06/2021,01/26/2021,20.0,SEN,acetaminophen diclofenac gel docusate sodium melatonin polyethylene glycol tramadol,Resident fell and fractured her pelvis in the week prior to vaccination,Alzheimer's dementia hypothyroidism insomnia Osteoarthritis of right knee,previously had hives with tetanus vaccine,amitriptyline codeine tetanus vaccine doxepin erythromycin,"['Chest X-ray', 'Computerised tomogram head', 'Computerised tomogram spine', 'Fall', 'General physical health deterioration', 'Head injury', 'Hypotension', 'Loss of consciousness', 'Tachycardia', 'X-ray of pelvis and hip']",1,MODERNA,IM 998616,CA,51.0,F,"**Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze deviation at midnight and admitted to hospital (last seen normal around 7 pm 1/24/2021). Intubated in ED, ABG 6.98/17/186 on 40%, Bicarb <5, Scr 1.4, Lactate 1, Wbc 20.3, BP 101/45-- >95/41, Temp 94.3, RR 23-32. Acidotic and initially required norepineprine for hypotension management (stopped 1/26/2021 0400 am) 1/26 to 2/1/2021 - supportive care for encephalopathy (anoxic vs. ischemic brain injury), ARF, HTN, MSSA growth in resp culture (no respiratory distress, on antibiotic) 1/28 GCS:E4VTM4; 1/29 GCS: EV4VTM4 with intact protective reflexes, extubated 2 pm 2/1 arousable, follows very simple commands, non verbal",Not Reported,,Yes,Yes,,Not Reported,U,01/20/2021,01/24/2021,4.0,SEN,"Haloperidol, Risperidone, Sertraline, Benztropine, Gabapentin, Ferrous Sulfate, Lisinopril, Multivitamin, Omeprazole, Simvastatin","Visited urgent care on 1/21 with c/o 2 weeks of bilateral lower leg pain and swelling worsening in the last week. Positive for orthopnea, baseline = able to walk several blocks, during urgent care visit = can't walk to the living room. CXR and BNP negative, left>right calf pain in size, ultrasound DVT bilateral negative. Sent home with OTC acetaminophen PRN, Diclofenac GEL PRN pain.","schizophrenia, major depression with psychotic features, intellectual disability, HTN, GERD",,"Amoxicillin, Penicillins","['Alanine aminotransferase normal', 'Angiogram cerebral normal', 'Arteriogram carotid normal', 'Aspartate aminotransferase increased', 'Atelectasis', 'Base excess increased', 'Blood albumin normal', 'Blood bicarbonate decreased', 'Blood bilirubin decreased', 'Blood calcium decreased', 'Blood chloride increased', 'Blood creatinine increased', 'Blood glucose increased', 'Blood pH decreased', 'Blood phosphorus increased', 'Blood potassium increased', 'Blood potassium normal', 'Blood sodium decreased', 'Blood urea increased', 'Carbon dioxide decreased', 'Chest X-ray normal', 'Coma acidotic', 'Computerised tomogram abdomen', 'Computerised tomogram head normal', 'Computerised tomogram thorax abnormal', 'Drug screen negative', 'Ejection fraction normal', 'Electroencephalogram normal', 'Encephalopathy', 'Endotracheal intubation', 'Gaze palsy', 'Hypertension', 'Hypotension', 'International normalised ratio increased', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging spinal', 'Overgrowth fungal', 'Oxygen saturation', 'Oxygen saturation normal', 'PCO2 decreased', 'Pain in extremity', 'Perfusion brain scan normal', 'Peripheral swelling', 'Protein total normal', 'Scan with contrast', 'Sputum culture positive', 'Staphylococcal sepsis', 'Tracheal aspirate culture', 'Tracheal aspiration procedure', 'Troponin normal', 'Unresponsive to stimuli', 'Urine ketone body present']",1,PFIZER\BIONTECH,IM 998637,NC,75.0,F,Patient noted to have irregular breathing in bed and unable to arouse. Provided life saving measures in the field x 30 minutes and transferred to hospital. Noted to have heart arrhythmia which suspected to cause cardiac arrest.,Yes,01/15/2021,Not Reported,Yes,1.0,Not Reported,N,01/13/2021,01/15/2021,2.0,PUB,,No known acute illness,Macular degeneration Dislipidemia,,None noted,"['Arrhythmia', 'Cardiac arrest', 'Irregular breathing', 'Resuscitation', 'Somnolence']",1,PFIZER\BIONTECH,IM 998639,NH,58.0,M,"Wheezing, Decrease in O2 saturation, Increase in RR, SOB, Temp of 99.3.Hospitalized.",Not Reported,,Yes,Yes,13.0,Not Reported,U,01/08/2021,01/21/2021,13.0,SEN,cefTRIAXone Sodium Solution Folic Acid Tablet Mag-Oxide Tablet (Magnesium Oxide) Senna Tablet 8.6 MG (Sennosides) Vitamin D3 Tablet (Cholecalciferol) Lactulose Solution 10 GM/15ML metFORMIN HCl Tablet Metoprolol Tartrate Tablet,Elevated WBC,"NSTEMI Myocardial infarct, Type 2 DM, HTN, CKD STAGE 3, ATHEROSCLEROTIC HEART DISEASE of native coronary artery, unspecified CHF",,NKA,"['Body temperature increased', 'Cardiomegaly', 'Chest X-ray abnormal', 'Dyspnoea', 'Fibrin D dimer increased', 'Full blood count', 'Laboratory test', 'Lung infiltration', 'Metabolic function test', 'Oxygen saturation decreased', 'Respiratory rate increased', 'Wheezing', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 998670,OR,87.0,F,At 2am on 2/3/21 resident began having trouble breathing. She had an audible wheeze and gurgling and critically low O2 sats. She has no history of breathing issues. She did not have any issues earlier that day. She was sent to the ER and admitted to the ICU for possible heart failure.,Not Reported,,Yes,Yes,,Not Reported,N,01/27/2021,02/03/2021,7.0,SEN,"Xanax, amlodipine, multivitamin, olmesartan, preservision, questran, B12, Vit D",none,"diarrhea, hypertension, anxiety, insomnia, nonrheumatic aortic valve stenosis, osteoporosis, hx colon cancer surgically removed, urinary retention, macular degeneration",,"Atenolol, Carbamazepine, Cefdinir, Diclofenac, Hydrochlorothiazide, Levofloxacin, Lovastatin, Nitrofurantoin, Paroxetine, Pravastatin, Sulfa Antibiotics, Beta-Blockers","['Cardiac failure', 'Dyspnoea', 'Intensive care', 'Oxygen saturation decreased', 'Wheezing']",1,PFIZER\BIONTECH,IM 998725,NY,95.0,F,Patient daughter reported that patient was admitted to Neurology with a stroke. She has cognitive and speech impairment as well as motor impairment. She was admitted either 2-2-21 or 2-3-21. She is still in the hospital.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/01/2021,02/02/2021,1.0,PHM,,,,,,"['Cerebrovascular accident', 'Cognitive disorder', 'Motor dysfunction', 'Psychomotor skills impaired', 'Speech disorder']",1,MODERNA,IM 998753,NC,57.0,M,"Patient came to the emergency department on 02/02/2020 at 2:30 pm to be evaluated for possible stroke due to sudden acute numbness, weakness in right wrist and arm, but no pain. Patient has no prior history of sudden acute numbness in arm and did not report any recent injury to his arm. Neurologist evaluated patient for possible stroke and patient was unable to lift right wrist and hand. Patient was able to lift both arms overhead, lift both legs, smile normal, open and close mouth and move tongue. Both CT Scan and MRI were normal. Neurologist and emergency medical specialist determined that patient did not have a stroke and diagnosed acute brachial plexus palsy possibly due to patient sleeping in an awkward position. Emergency specialist said it was unlikely but could not rule out the possibility of an adverse reaction to the Moderna vaccine, which patient had received 10 days earlier (second dose, see details above.)",Not Reported,,Not Reported,Not Reported,,Yes,N,01/22/2021,02/01/2021,10.0,PVT,Calcium carbonate / natural calcium 1000 mg po bid Cholecalciferol (Vit. D3) / Vitamin De 50 mcg po daily Cyanocobalamin/Cobamamide / Vitamin B-12 1000 mcg sl daily Glipizide 10 mg po daily Losartan potassium / Cozaar 100 mg po daily M,,"type-2 diabetes, hypertension",,allergy to shellfish,"['Blood pressure increased', 'Brachial plexus injury', 'Computerised tomogram normal', 'Hemiparesis', 'Magnetic resonance imaging normal', 'Mobility decreased', 'Muscular weakness', 'Neurological examination abnormal']",2,MODERNA,IM 998770,AR,91.0,F,"Patient had no symptoms or adverse events until the next evening after shot (1/29/21) where daughter reported her having heart palpitations. Family told her to rest and did not seek medical attention. Saturday afternoon (1/30/2021), patient started experiencing labored breathing. Daughter called 911 and before the ambulance arrived, the patient's breathing became more and more shallow. Patient was taken to the local hospital and passed away Saturday evening around 5:30 pm.",Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,PHM,OTC APAP prn Tradjenta 5mg daily amlodipine 10mg daily naproxen 500mg BID trazodone 100mg HS atorvastatin 20mg daily gabapentin 100mg TID timolol 0.5% eye drops 1 drop each eye BID metformin ER 500mg daily glipizide 10mg BID lisinopril 20m,,High blood pressure High Cholesterol Diabetes Restless Legs syndrome depression/anxiety,,NKA,"['Death', 'Dyspnoea', 'Hypopnoea', 'Palpitations']",1,MODERNA,IM 998774,TX,68.0,M,"Pericarditis with pericardial effusion. Treatment: Pericardiocentesis, Colchicine, Aspirin, Ibuprofen, Omeprazole Symptoms began (syncopal episode, retrosternal chest heaviness and aching worse with inspiration, fever, chills, lymphadenopathy for a for 9 days following vaccination) Outcome: Patient discharged home after 3 day hospitalization. Currently feeling better at 1 week follow up.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,01/15/2021,01/24/2021,9.0,UNK,Tylenol 650 mg q 6 hours as needed Aspirin 81 mg daily Clonazepam 1 mg as needed Colchicine 0.6 mg daily Famotidine 20 mg daily as needed Metoprolol tartrate 100 mg every 12 hours Omeprazole 20 mg daily as needed,None,Hypertension GERD Anxiety Recurrent syncopal episodes in the past New onset atrial fibrillation at time of adverse event,,No known drug allergies,"['Blood thyroid stimulating hormone', 'Body fluid analysis', 'Brain natriuretic peptide', 'C-reactive protein', 'Chest X-ray', 'Chest discomfort', 'Chest pain', 'Chills', 'Differential white blood cell count', 'Echocardiogram', 'Electrocardiogram', 'Full blood count', 'Lymphadenopathy', 'Metabolic function test', 'Pain', 'Painful respiration', 'Pericardial drainage', 'Pericardial drainage test', 'Pericardial effusion', 'Pericarditis', 'Pyrexia', 'SARS-CoV-2 test', 'Troponin', 'Urine analysis']",1,MODERNA,IM 998778,FL,91.0,M,"Inability to speak, increase drooling, lose of coordination, mouth twisted",Not Reported,,Not Reported,Yes,,Not Reported,U,02/02/2021,02/02/2021,0.0,OTH,,COVID 12/2020,"COPD,HTN,GERD,Gout,AFIB,DM, HYPERLIPIDEMIA,Insomnia,Vesicostomy, Alzheimer's Dementia, Infection and Inflammatory Reaction due to Penile Prosthesis",,"Metformin, Ambien, Repaglinide","['Aphasia', 'Coordination abnormal', 'Drooling', 'Dyskinesia']",2,PFIZER\BIONTECH,IM 998801,OR,43.0,F,"Anaphylaxis refractory to IM episode x3, steroids, H1 blocker requiring incubation. Specifically respiratory distress with stridor, nausea, and generalized abdominal pain.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/28/2021,01/28/2021,0.0,PVT,none,,Recurrent anaphylaxis,"Influenza, anaphylaxis (according to patient's report)","Influenza Vaccine, citric acid; penicillins; vancomycin; adhesive & tape; amoxicillin; aspirin; and naproxen","['Abdominal pain', 'Anaphylactic reaction', 'Chest X-ray', 'Condition aggravated', 'Laboratory test', 'Nausea', 'Respiratory distress', 'Stridor']",UNK,PFIZER\BIONTECH,IM 998863,SD,71.0,F,Cardiac Arrest with in an hour of receiving Covid vaccine; Brought into ED by EMS doing CPR; resuscitation continued in ED for 20 minutes before ROSC was achieved. Pt admitted to Critical Care.,Not Reported,,Yes,Yes,,Not Reported,N,02/02/2021,02/02/2021,0.0,PVT,,,Diabetes type 2 CAD CKD ESRD on dialysis Obesity Hyperlipidemia Hypertension,,No known allergies,"['Cardiac arrest', 'Intensive care', 'Resuscitation']",1,PFIZER\BIONTECH,IM 998876,MO,46.0,F,Had a severe headache that has never gone away. Jan 1st went to ER,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/22/2020,12/24/2020,2.0,PVT,"Spironolactone 100 mg, Nitrofurantoin 50 mg 3x a week as needed, Tretinoin 0.1 cream",No,No,,No,"['Computerised tomogram head', 'Headache', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 998887,WI,96.0,F,"Pt receieved her first dose of the Moderna COVID-19 on 12/29/2020. Lot number, route, and site not specified in medical record. No record of 2nd dose was found on medical record review. Pt was admitted to reporting hospital 2/2/2021 with an admitting diagnosis of failure to thrive/poor oral intake. Pt was reported in ER to have a sore throat, cough, shortness of breath, and general recent decline. Reported that pt and others in family had GI like illness about a week ago. Admission test for COVID was positive per PCR NP swab on 2/2/2021. Pt still currently admitted.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,12/29/2020,02/02/2021,35.0,UNK,"Amiodarone, calcium supplement, vit B-12 supplement, fluticasone nasal, folic acid, furosemide, hydrocortisone 1% cream, levothyroxine, senna-docusate.",,"Underweight, Tachycardia, severe mitral regurgitation, osteoporosis, MRSA, moderate tricuspid regurgitation, hypothyroidism, hypertension, hyperlipidemia, HX of MI, environmental allergies (unspecified), cataract, atrial fibrillation, CHF.",,No Known Allergies,"['COVID-19', 'Chest X-ray normal', 'Cough', 'Dyspnoea', 'Failure to thrive', 'General physical health deterioration', 'Hypophagia', 'Oropharyngeal pain', 'SARS-CoV-2 test positive']",1,MODERNA, 998890,FL,81.0,F,Around 1/27/21 patient noticed numbness of bilateral legs and progressive weakness. Admitted to hospital 1/29/21 and diagnosed with Guillen Barre. Initially paresthesia was from feet to groin and has been improving.,Not Reported,,Not Reported,Yes,6.0,Yes,N,01/12/2021,01/27/2021,15.0,SEN,none,none,neuropathy,,ginger,"['Guillain-Barre syndrome', 'Hypoaesthesia', 'Muscular weakness', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 998943,AZ,84.0,M,"Blurred vision, off balance, low blood pressure. Sent to ER and was admitted to hospital. Tested negative for Covid19 on 1/25/2021 at hospital. Returned to community 1/26/2021 and was sent to the ER within hours of being back from hospital. He remains at the hospital and will be returning on hospice.",Not Reported,,Not Reported,Yes,13.0,Yes,N,01/21/2021,01/21/2021,0.0,SEN,"Routine: Allopurinol 300mg, Amlodipine 5mg, Aspirin 81mg, Cefinir 300mg, Donepezil HCL 10mg, Finasteride 5mg, Losartan potassium 50mg, Memantine HCL ER 28mg, Metoprolol Tartrate 25mg, Oyster Shell Calcium 500mg, Probiotic, Quetiapine Fumar",12/31/2020 Fall/hemorrhagic stroke,"Dementia, Hypertension",,None known,"['Balance disorder', 'Hypotension', 'SARS-CoV-2 test negative', 'Vision blurred']",1,MODERNA, 998948,MD,22.0,F,"5 days after vaccine experienced irregular heartbeat and fast heart rate. Never had this before. Went to hospital where HR and BP extremely elevated. Observed overnight in hospital, placed on beta blocker and had Holter monitoring.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/11/2021,01/16/2021,5.0,PUB,Effexor 225 mg LoLoestrin Metroprolol 12.5 mg,POTS postural orthostatic tachcardia,,,"nuts, seafood, sesame","['Blood pressure increased', 'Electrocardiogram ambulatory', 'Heart rate increased', 'Heart rate irregular']",1,PFIZER\BIONTECH,IM 999014,PA,35.0,F,"Cholestasis of pregnancy developed at 37 weeks and 2 days. Was induced at 38 weeks. Normal LFTS and bile acids. Boy was born on 1/16 Weighing 6 pounds 0 oz. apgar 9 &9. Baby developed Coombs + Hemolysis, from presumed ABO incompatiblity. Due date 1/30.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/07/2021,01/11/2021,4.0,PVT,Prenatal vitamins Ferrous gluconate,None,None,,None,"['Apgar score normal', 'Blood bilirubin increased', 'Cholestasis of pregnancy', 'Exposure during pregnancy', 'Haemolysis', 'Hyperbilirubinaemia', 'Induced labour', 'Liver function test normal', 'Total bile acids']",1,MODERNA,IM 999018,CA,61.0,M,Shortness of breath Desaturation,Not Reported,,Not Reported,Yes,,Not Reported,Y,02/01/2021,02/02/2021,1.0,OTH,,NONE,ESSENTIAL (PRIMARY) HYPERTENSION TYPE 2 DIABETES MELLITUS END STAGE RENAL DISEASE DEPENDENCE ON RENAL DIALYSIS HEART FAILURE PERSONAL HISTORY OF COVID-19,,NO KNOWN ALLERGIES,"['Dyspnoea', 'Oxygen saturation decreased']",2,MODERNA,IM 999066,UT,26.0,F,"Sore arm after injection. I could bearly move it. Fever chills, weakness headache and body pains for 24 hours. I did not seek treatment but I will be letting my OBGYN know at the next appointment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2020,01/23/2020,1.0,WRK,"Wellbutrin 150mg OD (extended release), Prozac 40mg OD",cold prior to vaccine,no,,no,"['Asthenia', 'Chills', 'Headache', 'Mobility decreased', 'Pain', 'Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 999069,NY,51.0,F,"On Friday, 1/29, after receiving the vaccine, I experience a headache, sharp right side pain in my neck, jaw, and ear. On Saturday, 1/30, I woke up, and the right side of my face was numb, and my right eye would not blink. I went to ER. When they took my vitals, I had high blood pressure and fever. They did a CT scan of my head and admitted me. I was diagnosed with Bell's Palsy. I was discharged on Sunday, 1/31, with medications: Valacyclovir 1 gram three times a day and Prednisone 20 mg three times a day. I was instructed to followup with a neurologist, immunologist, ophthalmologist, and my primary care physician.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/29/2021,01/29/2021,0.0,PVT,"GNC One Daily Multivitamin, GNC Collagen, GNC Probiotic, Turmeric Curcumin 500mg, Biotin 5000mg, Apple Cider Vinegar Gummies, Nature's Truth Melatonin 10 mg gummies","No, but I had back pain for a few weeks prior that radiated to my legs",Asthma,,No,"['Computerised tomogram head', 'Computerised tomogram neck', 'Ear pain', 'Eyelid function disorder', 'Facial paralysis', 'Headache', 'Hypertension', 'Hypoaesthesia', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging neck', 'Neck pain', 'Pain in jaw', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 999135,MA,53.0,F,"No trauma Got dose, works as cleaner. Received in Left deltoid. Lot 013L20A Moderna. For first 3 days, had typical pain she would receive from influenza vaccination 3 days after started to have redness at injection site as well as swelling. Swelling subsided but as soon as swelling improved, pain got worse radiating from shoulder down arpit and to left hand. Numbness and tingling also radiated distally. 3 ED visits--on 1/25 and two on 1/27 giving APAP, diclofenac gel, lidocaine patch, and sling. Workup showed mildly elevated alk phos (129), CK normal 57, WBC unremarkable with absolute eois wnl. XR imaging unremarkable. No DVT L upper extremity. Today, pain in deltoid controlled with APAP 500mg x 2 along with lidocaine patch. But biggest concern for patient is the radiating pain and numbness / tingling down her L arm that has not gone away with anything. Reports significant pain in elbow radiating to lower arm at night. Further workup is still pending.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/15/2021,01/18/2021,3.0,WRK,"ciprofloxacin-dexamethasone (CIPRODEX) otic suspension. unclear if was taking this but on her med list. amLODIPine (NORVASC) 2.5 MG tablet, unclear if was taking this but on her med list. Vit B 12 and D supplements",none,HTN HEARING LOSS SENSORINEURAL Vit B12 deficiency Vit D deficiency +PPD,,"Apples, cranberries - facial swellilng and itching Anaphylaxis to seafood Canasa [Mesalamine] - rash Bactrim [Sulfamethoxazole-trimethoprim] Shortness of Breath, Rash","['Arthralgia', 'Axillary pain', 'Blood alkaline phosphatase increased', 'Blood creatine phosphokinase normal', 'Chest X-ray normal', 'Eosinophil count normal', 'Hypoaesthesia', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Ultrasound Doppler normal', 'White blood cell count normal', 'X-ray limb normal']",1,MODERNA,IM 999146,WI,67.0,M,"The patient had an acute myocardial infarction of the anterolateral wall of the heart. He was brought to the emergency room . He arrived at the hospital at 1605, was stabilized and transferred at 1705 to a different hospital.",Not Reported,,Yes,Yes,4.0,Not Reported,Y,01/27/2021,01/27/2021,0.0,OTH,"Multiple vitamin, Aspirin 81mg daily, Glucosamine/Chondroitin 1 daily, Metformin ER 500mg twice daily",None,"Coronary Atherosclerosis, Polymyalgia rheumatica, Type 2 diabetes Mellitus",,No known allergies,['Acute myocardial infarction'],1,MODERNA,IM 999192,WI,76.0,F,"According to the staff at the Hospital, the patient was treated in their emergency room for a stroke this morning at approximately 730AM",Not Reported,,Yes,Yes,1.0,Not Reported,U,02/02/2021,02/03/2021,1.0,OTH,"Atenolol 25mg daily, Atorvastatin 20mg daily at bedtime, Hydralazine 50mg 4 times daily, Hydrochlorothiazide 25mg daily, Lansoprazole 30mg daily, Levothyroxine 75mcg daily, Lisinopril 20mg twice daily, Meclizine 25mg 4 times daily as need,",None,"Barrett's Esophagus, Cerebral Ischemia, Chronic Renal Insufficiency, Diabetes Mellitus, Essential Hypertension, Hyperlipidemia, Hypothyroidism, Irritable Bowel Syndrome, Osteoarthritis.",,"Carvedilol, Amlodipine, Hydrocodone",['Cerebrovascular accident'],1,MODERNA,IM 999315,SD,68.0,M,"Administered 2nd COVID vaccine Friday 1/29/2021. Nothing out of the ordinary. The next morning on Saturday 1/30/2021, he was found on the floor in his room- responsive, but disoriented. He could not move his left side. The ambulance was called immediately.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/29/2021,01/30/2021,1.0,SEN,,,,,"IBUPROFEN, FOSAMAX, SULFA","['Disorientation', 'Hemiplegia', 'Movement disorder']",2,PFIZER\BIONTECH,IM 999328,AZ,37.0,M,Bells Palsy possible Guillans Bare,Not Reported,,Not Reported,Yes,3.0,Yes,N,01/13/2021,01/27/2021,14.0,OTH,None,None,None,,Cipro,"['Antibody test', 'Blood test', 'Computerised tomogram', 'Electromyogram', 'Epstein-Barr virus test', 'Facial paralysis', 'Full blood count', 'Gram stain', 'HIV test', 'Immunoglobulins', 'Lumbar puncture', 'Magnetic resonance imaging', 'Neisseria test', 'Treponema test']",1,PFIZER\BIONTECH, 999423,MN,79.0,M,2 unconscious episodes and a lactate of 8.7,Not Reported,,Not Reported,Yes,,Not Reported,U,02/03/2021,02/03/2021,0.0,PVT,"Alphabetical Last DoseTimeTaking? TodayYesterdayPast WeekPast MonthGreater than 1 MonthUnknown at aspirin 81 MG tablet Take 81 mg by mouth 1 time per day Informant: Spouse, Last Dose: 2/3/2021 at 0800 TodayY",,"Dysuria 9/30/2009 Entered by Unlisted, Provider Essential hypertension Unknown Entered by Unlisted, Provider Related Goals Emergency Plan of Care Generalized weakness 2/3/2021 History of Mobitz type I atrioventricular block 2/3/2021 History of seizures 2/3/2021 Impotence of organic origin Unknown Entered by Unlisted, Provider Interstitial lung disease (Chronic) 5/18/2017 Left leg pain 4/17/2020 Leg pain 4/17/2020 Microscopic hematuria 9/30/2009 Entered by Unlisted, Provider Myalgia and myositis 5/24/2011 Entered by Unlisted, Provider Obesity 9/15/2008 Entered by Unlisted, Provider OSA treated with BiPAP 8/29/2017 Other specified abnormal findings of blood chemistry 2/5/2010 Entered by Unlisted, Provider Panlobular emphysema 5/5/2016 Perforation of tympanic membrane 3/10/2011 Entered by Unlisted, Provider Primary insomnia 12/20/2015 Pulmonary fibrosis 8/29/2017 Simple chronic serous otitis media 10/16/2008 Entered by Unlisted, Provider Syncope and collapse 2/3/2021 Weakness 4/17/2020 Wrist arthritis",,"Allergies Penicillin Hives (High), Rash High 10/19/2012 Past Updates... Dermatological problems Bactrim [Sulfamethoxazole W-trimethoprim] Hives (High) High 9/23/2019 Past Updates... Linezolid","['Alanine aminotransferase normal', 'Aspartate aminotransferase normal', 'Band neutrophil count', 'Band neutrophil percentage', 'Basophil count decreased', 'Bilirubin conjugated', 'Blood albumin', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bilirubin increased', 'Blood bilirubin normal', 'Blood bilirubin unconjugated', 'Blood calcium', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatine increased', 'Blood creatinine increased', 'Blood glucose increased', 'Blood lactic acid', 'Blood magnesium', 'Blood phosphorus', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea normal', 'Carbon dioxide normal', 'Diabetes mellitus', 'Eosinophil count decreased', 'Eosinophil count increased', 'Eosinophil percentage', 'Full blood count', 'Haematocrit normal', 'Haemoglobin normal', 'International normalised ratio', 'Laboratory test', 'Liver function test', 'Loss of consciousness', 'Lymphocyte percentage decreased', 'Monocyte percentage', 'Neutrophil percentage increased', 'Platelet count normal', 'Protein total normal', 'Prothrombin time', 'White blood cell count normal']",UNK,PFIZER\BIONTECH, 1000754,NJ,89.0,F,"on 2/1/2021 Resident Reported Back pain given Tylenol Medication orally For Relief. APPRoximately 30 Min Later. complaint of & Noted Diarrhea, Shivering, and vomiting SenT To ER 2/1 And Admitted Diagnosis: Sepsis",Not Reported,,Yes,Yes,,Not Reported,U,01/25/2021,02/01/2021,7.0,OTH,CENTRUM SILVER; FOLIC ACID; B-12; ALENDRONDATE SODIUM; METOPROLOL SUCCINATE ER; VITAMIN C; RIDAURA; METHENAMINE HIPPURATE; DOK; SENNA; RESTASIS; CALCIUM+D3; ASPIRIN; PREDNISONE; CRANBERRY CONCENTRATE; FAMOTIDINE; ACETAMINOPHEN EXTRA STRENGT,"Lower Back Pain Essential, SIALOADENITIS NONINFECTIVE GASTROENTERITIS AND COLITIS, CONSTIPATION, OTHER SPECIFIED ARTHRITIS, UNSPECIFIED SITE, AGE-RELATED OSTEOPOROSIS WITHOUT CURRENT PATHOLOGICAL FRACTURE, URINARY TRACT INFECTION SITE NOT SPECIFIED COUGH RASH AND OTHER NONSPECIFIC SKIN ERUPTION Localized swelling, mass and lump, lower limb, bilateral, ANXIETY DISORDER, OTHER INJURY OF UNSPECIFIED BODY REGION, ENCOUTER FOR SCREENING FOR RESPIRATORY TUBERCULOSIS, LONG TERM (CURRENT) USE OF ASPIRIN",Lower Back Pain,,"CIPRO, Avelox, TRamado HCL","['Back pain', 'Chills', 'Condition aggravated', 'Diarrhoea', 'Sepsis', 'Vomiting']",2,PFIZER\BIONTECH,IM 1000775,NJ,99.0,F,"on 1/26/21 Found laying on Bathroom Floor in Bedroom Apt. Complaint of Right Shoulder paiN bleeding (unknown origin) then discovered origin HANd/FiNgers. (Head on Floor towARds WALL) SeNT TO ER 1/26/21, Admitted 1/26/21 Diagnosis: AoRtic STENOSIS",Not Reported,,Yes,Yes,5.0,Not Reported,Y,01/25/2021,01/26/2021,1.0,OTH,Amlodipine besylate; aspirin; atorvastatin calcium; metoprolol succinate ER; acetaminophen; furosemide; trazodone hydrochloride; hyoscyamine sulfate; lorazepam; prochlorperazine maleate; morphine sulfate; bacitracin,"Bilateral lower Extremities Edema; bacterial infection, unspecified","Rheumatic aortic steno; essential (primary) hyper; malignant neoplasm of; localized edema; unspecified dementia w; unspecified glaucoma; unspecified osteoart; bacterial infection, un; non-pressure chroni; dysphagia, unspecified; non-ST elevation (NSTEM",,No Known Allergies per chart,"['Aortic stenosis', 'Arthralgia', 'Haemorrhage']",1,PFIZER\BIONTECH,IM 1002918,,97.0,M,Narrative:,Not Reported,,Not Reported,Yes,,Not Reported,U,09/23/2020,09/23/2020,0.0,OTH,,,,,,['Unevaluable event'],UNK,SANOFI PASTEUR, 1002925,,79.0,M,"COVID(+) Narrative: Patient developed COVID-19 symptoms on 1/16, approximately 2 days after receiving dose #1 COVID vaccine. He was admitted on 1/30 with worsening symptoms of fatigue, low grade fever, myalgias, dyspnea, and productive cough and found to be COVID(+) via Cepheid test. Patient was treated with supplemental oxygen and oral dexamethasone therapy.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/14/2021,01/30/2021,16.0,OTH,,,,,,"['Alanine aminotransferase', 'Aspartate aminotransferase', 'Blood creatinine', 'Blood lactate dehydrogenase', 'Blood test', 'Blood urea', 'Blood urea nitrogen/creatinine ratio', 'C-reactive protein', 'COVID-19', 'Dyspnoea', 'EGFR status assay', 'Fatigue', 'Fibrin D dimer', 'Glomerular filtration rate', 'Myalgia', 'Productive cough', 'Pyrexia', 'SARS-CoV-2 test positive', 'Serum ferritin', 'White blood cell count']",1,PFIZER\BIONTECH,IM 1002931,,77.0,M,"CARDIAC ARREST, DEATH Narrative: The patient presents to the emergency department in cardiopulmonary arrest. CPR was continued upon arrival. The Combi tube was removed and an endotracheal tube was placed without complications. ROSC was obtained multiple times but the patient continued to go into PEA. The patient was seen in the emergency department by both critical care and Cardiology. EKG shows ST elevations, but the patient was unstable to go to catheterization. The patient had 1 episode of asystole. Despite best efforts and multiple attempts we were unable to resuscitate the patient. Time of death 1253 on 1/24/21.",Yes,01/24/2021,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/24/2021,3.0,OTH,,,,,,"['Absence of immediate treatment response', 'Cardiac arrest', 'Cardio-respiratory arrest', 'Death', 'Electrocardiogram ST segment elevation', 'Endotracheal intubation', 'Pulseless electrical activity', 'Resuscitation']",1,MODERNA,IM 1002937,,73.0,M,"death Narrative: Pt attended arthritis clinic appt 0900; labs shortly after; rec'd vaccine in clinic ~ 1113; seen on surveillance camera walking to parking garage ~ 1145; medical center rec'd call from wife ~ 1900 that pt never returned home; police found vehicle running in parking garage, code called, pt obviously deceased by that time 1930, body sent to medical examiner for autopsy.",Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,OTH,,,,,,"['Autopsy', 'Cardio-respiratory arrest', 'Death']",UNK,PFIZER\BIONTECH,IM 999902,CA,,F,"Heart murmur; Increase in her blood pressure 190/105; Tightness in chest when breathing; Blurry vision; A spontaneous report was received concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an increase in blood pressure 190/105, blurry vision, tightness in the chest when breathing and a heart murmur. The patient's medical history was not provided. No relevant concomitant medications were reported. On 26 Dec 2020, approximately 30 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Dec 2020, the patient received the Moderna vaccine and after 30 minutes, she experienced an increase in her blood pressure (190/105), blurry vision and tightness in the chest when breathing. She remained at the site for an hour for observation and then was brought to the urgent care. An electrocardiogram (EKG) was performed and treatment included oral lisinopril. She was sent home, and she also stated that she had a heart murmur. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, increase in blood pressure 190/105, blurry vision, tightness in the chest when breathing, and a heart murmur, were not reported.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of blood pressure increased, and non-serious unexpected event of chest discomfort, vision blurred, and cardiac murmur. The events occurred 1 day (15 min) after first dose of mRNA-1273, lot # 037K20A. Treatment included lisinopril. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/26/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Blood pressure increased', 'Cardiac murmur', 'Chest discomfort', 'Electrocardiogram', 'Vision blurred']",1,MODERNA,OT 999903,KY,63.0,M,"Bronchitis; COVID-19; A spontaneous report was received from a consumer concerning a 63-year-old, male, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed COVID-19 and bronchitis. The patient's medical history, as provided by the reporter, included asthma and unspecified allergies. Concomitant product use included unspecified allergy medication and asthma/bronchitis inhalers. On 02 Jan 2021, the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 02 Jan 2021, the patient experienced coughing, wheezing, shortness of breath, headache, and sinus congestion. The patient tested positive for COVID-19. The patient was taken to the hospital where he was treated with an infusion. On an unspecified date, a computed tomography scan showed bronchitis. Additional treatment for the events included unspecified antibiotics and steroids. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events COVID-19 and bronchitis was unknown.; Reporter's Comments: This spontaneous report concerns a 63-year-old male patient who experienced the serious events of COVID-19 and bronchitis. The event occurred on the same day after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: Unknown, expiration date-Unknown). Treatment administered included antibiotics and steroids. Outcome was unknown. Although a temporal association exist, there is not enough information to adequately assess the causal association between the reported events and mRNA-1273 vaccine administration. Critical details such as diagnostic test for COVID infection prior to vaccination was not ascertained. Causality is also confounded by the patient's advanced age. Main field defaults to �possibly related'",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/02/2021,0.0,UNK,,Allergy (unspecified allergies); Asthma,,,,"['Bronchitis', 'COVID-19', 'Computerised tomogram abnormal', 'Cough', 'Dyspnoea', 'Headache', 'SARS-CoV-2 test positive', 'Sinus congestion', 'Wheezing']",1,MODERNA,OT 999904,CA,36.0,M,"Fainted; Disoriented and didn't know what was happening; Feels a little dizzy; Lethargy; Tenderness in the arm; A spontaneous report was received from a consumer who was a 36-year-old, male, patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fainted, tenderness in the arm, lethargy, disoriented and didn't know what was happening, and feels a little dizzy. The patient's medical history was not provided. No relevant concomitant medications were reported. On 14 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 25L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the evening of 14 Jan 2021, the patient had tenderness in the arm and felt lethargic. On 15 Jan 2021, the patient fainted when he woke up in the morning. The patient's legs gave out and he fell into the wall. The patient was disoriented and didn't know what was happening. The patient reported the event as happening pretty quick and described it as ""like he had very low blood sugar"". The patient reported that sometimes when he gets up too quickly, he feels a little dizzy. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, fainted, tenderness in the arm, lethargy, disoriented and didn't know what was happening, and sometimes when he gets up too quickly, was unknown. The event, feels a little dizzy, was considered not resolved.; Reporter's Comments: This spontaneous report refers to a case of a 36-year-old male patient who experienced events of fainted, tenderness in the arm, lethargy, disoriented and didn't know what was happening, and feels a little dizzy. The events developed on the following day after the administration of the mRNA-1273 vaccine (Lot # 25L20A, expiration date-unknown). No treatment was reported, and outcome is resolved for dizziness and unknown for all other events. Based on the information provided which includes a temporal association, a causal association cannot be excluded",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Disorientation', 'Dizziness', 'Fall', 'Lethargy', 'Muscular weakness', 'Syncope', 'Tenderness']",1,MODERNA,OT 999905,NY,23.0,F,"Deviation from the interval between doses; A report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and receiving the second dose 21 days before the recommended 28 days. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received the first of two planned doses of mRNA-1273 on an unspecified date. On 04 Jan 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection. The reported stated that the patient received the second shot 21 days before the 28 days recommended at the hospital. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event was unknown/not reported.; Reporter's Comments: This case concerns a female patient of unknown age who received the first of two planned doses of mRNA-1273 on an unspecified date and received the second dose 21 days before the recommended 28 days. There were no reported adverse events after the vaccine was administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/25/2021,21.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Inappropriate schedule of product administration'],1,MODERNA, 999906,MA,,M,"Syncopal episode while driving; Crash; Became extremely warm; Sweaty; Right flank pain; A spontaneous report was received from a nurse concerning her husband, a 53-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced became extremely warm, sweaty, right flank pain, a syncopal episode while driving, and crash. The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 Jan 2021, approximately two and a half hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient felt fine for approximately two and a half hours after receiving the vaccine, then became extremely warm, sweaty, developed right flank pain, and had a syncopal episode while driving. The nurse mentioned that the patient was not seriously injured in the crash, nor was anyone else. No treatment information was provided. It was also reported that the patient had followed up with his PCP and seen a cardiologist, some diagnostics were scheduled, and plans to see a neurologist. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events, became extremely warm, sweaty, developed right flank pain, syncopal episode while driving, and crash, was unknown.; Reporter's Comments: This case concerns a 53-years-old male patient, who experienced serious unexpected events of syncope and non-serious unexpected event of road traffic accident, feeling hot, hyperhidrosis, and flank pain. The events occurred 1 day (approximately 2.5 hours) after first dose of mRNA-1273, lot # unknown. Treatment details not provided. Very limited information regarding these events has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/11/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Flank pain', 'Hyperhidrosis', 'Road traffic accident', 'Skin warm', 'Syncope']",1,MODERNA,OT 999922,,,M,"tested positive for COVID; tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect from a contactable healthcare professional. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID on 17Jan2021. The patient underwent lab tests and procedures which included a positive COVID test on 17Jan2021. The outcome of tested positive for COVID was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .; Sender's Comments: Based on the information provided, the positive COVID-19 test is unlikely related to suspect BNT162B2 administration. The available injection date and detailed clinical course would be helpful for further assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/17/2021,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 999930,,,U,"was asymptomatic but has received a positive test result since receiving the 1st dose of vaccine; was asymptomatic but has received a positive test result since receiving the 1st dose of vaccine; This is a spontaneous report from a contactable Other-HCP. An HCP patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was asymptomatic but has received a positive test result since receiving the 1st dose of vaccine. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive. The outcome of event was unknown. The reporter queried whether the second vaccine doses have to be administered on the 21st day after the first dose, or whether there is a window of time in which it can be administered. The reporter queried whether this patient can continue with the normal vaccination schedule, or do they need to delay their second shot. Information on the batch number/lot number has been requested.; Sender's Comments: There is no available injection date of vaccine BNT162B2 or event onset date. Based on the information provided, the Company considers that the asymptomatic carrier with positive COVID-19 is unlikely related to suspect BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 999986,CT,,F,"Has early signs of covid; tested positive on covid; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A female patient of an unspecified age received 2 doses of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported that she has early signs of covid. She tested positive for covid n unspecified date. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 999987,,27.0,F,"She tested positive for COVID-19 following the first dose; She tested positive for COVID-19 following the first dose; This is a spontaneous report from a contactable healthcare professional. A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1686, expiration date:Mar2021), via an unspecified route of administration (left arm) on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient was asking when she can receive the second dose of the COVID vaccine if she tested positive for COVID-19 following the first dose. She received the first dose of the vaccine on 12Jan2021 and tested positive for COVID-19 on 14Jan2021. The patient underwent lab tests and procedures which included POC rapid COVID test: two negative tests on unspecified date, before getting the vaccine, she is tested twice weekly for work, and positive on 14Jan2021. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/14/2021,2.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 999990,AZ,52.0,M,"positive for COVID; positive for COVID; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EH9899, on 28Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient took the first dose of the Pfizer COVID Vaccine on 28Dec2020. After that he showed positive for COVID. He was scheduled for the second dose today (18Jan2021). He had taken a COVID test and tested positive for COVID. He was trying to re-schedule an appointment. They told him to contact his doctor, which he did. His doctor had suggested that he took the second booster on 24Jan2021, instead of today. The patient took a covid test Last Friday (15Jan2021) and tested positive also, He didn't believe the results so he tested again today (18Jan2021) and the result was also positive. Both tests were rapid tests. What made him take the test, the following Wednesday, he had a dry cough. He took OTC cough medicine and it stopped the dry cough. No other symptoms, not coughing today. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,,,UNK,,,,,,"['COVID-19', 'Cough', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 999991,FL,72.0,F,"positive for COVID; positive for COVID; cough; She felt lethargic and had a dull headache; She felt lethargic and had a dull headache; Her arm hurt the night of the vaccine and the following day; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. This consumer (patient) reported similar events for two patients (patient's husband and patient). This is the first of two reports. A 72-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot EH9899), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunisation. Medical history included cholesterol. Concomitant medication included pravastatin sodium (PRAVACOR) for cholesterol, levothyroxine sodium (SYNTHROID), she had been taking both at least 10 years and were ongoing. The patient experienced her arm hurt the night of the vaccine and the following day since 04Jan2021. She had been tested a few times. Tested in (state) and then came to (state). Quarantined for two weeks and test were negative. She had COVID testing on 11Jan2021 and got results were 13Jan2021. She experienced positive for covid on 11Jan2021, cough and she felt lethargic and had a dull headache on 06Jan2021, she had a mild case, did not have a fever, she went to the walk in clinic, had lungs checked, her oxygen level was normal, she had been testing normal, she did not have any severe symptoms of the COVID, she got post nasal drip and She started Azithromycin on 11Jan2021. The patient was such a careful person. When she went to the supermarket, she wore a shield, mask, and gloves. She did not socialize, was home body. She had no idea how she got it. She did call her internist when she found out she had it. The patient underwent lab tests and procedures which included oxygen level: normal in Jan2021, oxygen level: good on an unknown date, COVID test: negative on an unknown date, COVID test: positive on 11Jan2021, lung checked: clear in Jan2021, testing: normal in Jan2021. The even outcome was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/04/2021,0.0,OTH,PRAVACOR; SYNTHROID,,Medical History/Concurrent Conditions: Cholesterol,,,"['COVID-19', 'Cough', 'Headache', 'Lethargy', 'Pain in extremity', 'SARS-CoV-2 test positive', 'Upper-airway cough syndrome']",1,PFIZER\BIONTECH, 999992,,,U,"patient tested positive for Covid after receiving the first dose; patient tested positive for Covid after receiving the first dose; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 7 patients. This report is for 1st of 7 patient. A patient of unspecified age and gender received the first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that 7 coworkers was tested positive for Covid after receiving first dose of the Pfizer Covid vaccine on an unspecified date. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : 2021045638 same drug/AE, different patient;2021045639 same drug/AE, different patient;2021045643 same drug/AE, different patient;2021045641 same drug/AE, different patient;2021045642 same drug/AE, different patient;2021045640 same drug/AE, different patient;US-PFIZER INC-2021045639 same drug/AE, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 999993,,,U,"patient tested positive for Covid after receiving the first dose; patient tested positive for Covid after receiving the first dose; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 7 patients. This report is for 2nd of 7 patients. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that patient tested positive for COVID after receiving the first dose of the vaccine on an unspecified date. The outcome of events was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045622 same drug/AE, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 999994,,,U,"patient tested positive for Covid after receiving the first dose; patient tested positive for Covid after receiving the first dose; This is a spontaneous report from a contactable consumer. This consumer reported same event for seven patients. This is the third of 7 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that seven (7) coworkers tested positive for COVID after receiving 1st dose of the Pfizer Covid vaccine on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045622 same drug/AE, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 999995,,,U,"patient tested positive for Covid after receiving the first dose; patient tested positive for Covid after receiving the first dose; This is a spontaneous report from a contactable consumer. This consumer reported the same event for seven (7) patients. This is the fourth of the seven (7) reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer reported that seven (7) coworkers/ patients tested positive for Covid on an unspecified date after receiving the first dose of the Pfizer Covid vaccine. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045622 same reporter/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 999996,,,U,"patient tested positive for Covid after receiving the first dose; patient tested positive for Covid after receiving the first dose; his is a spontaneous report from a contactable consumer. This consumer reported similar events for seven patients. This report is for the sixth of seven patients. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, also reported as Pfizer Covid vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid after receiving the first dose of the Pfizer Covid vaccine on an unspecified date. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045622 same drug/AE, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 999997,FL,74.0,M,"both have COVID; both have COVID; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 15Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from two contactable consumers (patient's wife and patient) via a Pfizer-sponsored program, Pfizer First Connect. This consumer (patient's wife) reported similar events for two patients. This is the second of two reports. A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EH9899, unknown expiration), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization in a clinic. Medical history included prostate cancer, off rapid radiation (over two years ago by robotic surgery. He followed all the recommendations for rapid off radiation, no side effects. He took hormone therapy. He is cured), acid reflux, allergies (takes antihistamine when allergies act up; his allergies blossomed because of the leaves), and he used to be five nine, but he shrunk a little. Concomitant medications included rosuvastatin, acetylsalicylic acid (BABY ASPIRIN), losartan, pantoprazole for he had a bout with acid reflux, and tadalafil. The patient's wife and the patient both received the COVID-19 vaccine on 04Jan2021 and stated they have a mild case; they did not have any severe symptoms of the COVID and did not have a fever. The patient's oxygen level was normal. The patient's wife confirmed that she and her husband both had the vaccine on the same day and they both have COVID. The patient got a cough and was going to go the (clinic name). They went there and had lungs checked. Their lungs were clear and oxygen level was good. They both have been tested a few times. The patient's wife and the husband quarantined for two weeks and test were negative. When they were there this past Monday, they were asked if they wanted to be tested. They both got the results on Wednesday and were shocked; they were now quarantining again. COVID testing was done on 11Jan2021 and got the positive results on 13Jan2021. The patient's wife and the husband gave them a card, for when to come back. It was given at a drive through clinic in (county name). The patient feels fine and is sleeping well. The patient recovered from the event in Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045610 same reporter/drug, similar events in different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/13/2021,9.0,OTH,ROSUVASTATIN; BABY ASPIRIN; LOSARTAN; PANTOPRAZOLE; TADALAFIL,,Medical History/Concurrent Conditions: Acid reflux (oesophageal); Allergy to plants (takes antihistamine when allergies act up; allergies blossomed because of leaves.); Body height decreased; Prostate cancer; Radiation therapy (over 2 yrs ago by robotic surgery; followed all the recommendations for rapid off radiation),,,"['COVID-19', 'Cough', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000000,CA,,M,"tested positive; tested positive; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first shot a couple of weeks ago but tested positive later that day. The patient wanted to know how effective the vaccine was. The patient underwent lab test and procedure which included COVID: positive on unspecified date. Outcome of the event was unknown. Information on the batch/lot number has been requested.; Sender's Comments: There is not a reasonable possibility that event ""tested positive"" is related to BNT162B2. The event occurred on the same day the patient got vaccination, when the vaccine is not expected to achieve the protection. The event is most likely intercurrent medical condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000001,WI,,F,"covid symptoms the 28th and tested positive; covid symptoms the 28th and tested positive; This is a spontaneous report from a Pfizer sponsored program from a contactable Nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 around 2 pm at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Dec2020 the patient experienced covid symptoms the 28th and tested positive. The patient underwent lab tests and procedures which included covid test positive on unknown date. The outcome was unknown. The information on the batch/lot number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 28Dec2020, and COVID-19 test positive on the same day. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000003,PA,29.0,F,"rash and hives all over body; rash and hives all over body; This is a spontaneous report from a contactable healthcare professional (reported for herself). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EJ1685; expiry date: not known), intramuscular in the left arm on 17Jan2021 08:30 at single dose for COVID-19 immunization. There was no medical history. The patient is not pregnant. No known allergies. Concomitant medication included unspecified medication (other medication given in two weeks). No other vaccine in four weeks. No COVID prior to vaccination and not tested with COVID post vaccination. The patient experienced rash and hives all over body on 18Jan2021 11:00. These resulted in physician's clinic visit. Therapeutic measures were taken as a result of rash and hives all over body with prednisone, Benadryl, and Kenalog. The outcome of the events was recovered in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/17/2021,01/18/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Rash', 'Urticaria']",1,PFIZER\BIONTECH,OT 1000006,,,F,"tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable Other Health Professional (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiry date unknown, via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. It was reported that the patient got the first dose of vaccine 28Dec2020 and tested positive for COVID on 04Jan2021 but mentioned that her quarantine period is already over. She stated that she is scheduled to get the 2nd dose of the vaccine tomorrow, but wants to know if she should still proceed to receiving it. The patient underwent lab tests and procedures which included covid: positive on 04Jan2021. The outcome of the events was unknown. Information on lot/batch number has been requested.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (7 days in this case). However, a causal relationship between event ""tested positive for Covid "" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000007,WI,53.0,M,"blood sugar has been out of control ranging from 250-300; This is a spontaneous report from a contactable consumer. A 53-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration, on the right arm, on 14Jan2021 at a single dose for Covid-19 immunization. Medical history included type 2 diabetes mellitus from Sep2019 and ongoing. There were no concomitant medications. On 14Jan2021, it was reported that 8-10 hours after getting the vaccine, his blood sugar was out of control ranging from 250-300. On 15Jan2021, he has taken his blood sugar twice at the time of report. He took it when he woke and it was 207. Two hours after eating a light breakfast it was 242. The outcome of the event was not recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,UNK,,Type 2 diabetes mellitus,,,,"['Blood glucose increased', 'Diabetes mellitus', 'Diabetes mellitus inadequate control']",1,PFIZER\BIONTECH, 1000012,,,F,"The patient received the vaccine on 31Dec2020 and then tested positive a week later; The patient received the vaccine on 31Dec2020 and then tested positive a week later; This is a spontaneous report from a contactable other HCP (healthcare professional) via a Pfizer-Sponsored Program,. A 41 (units not provided) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 31Dec2020 (at an unspecified age) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient received the vaccine on 31Dec2020 and then tested positive a week later. The patient stated that she was supposed to receive the vaccine this Thursday and she wanted to know if she could receive the vaccine. The clinical outcome of the event ""the patient received the vaccine on 31Dec2020 and then tested positive a week later"" was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/01/2021,1.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000013,,,M,"got tested and tested positive; Got tested and tested positive; lethargic; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (husband and wife). This is the second of two reports (for the husband). A 74-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; lot number and expiry date were not reported), via an unspecified route of administration on 04Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, reported as two days after, the patient was lethargic. A week ago on an unspecified date, reported as past Monday, the patient had no cough, no fever, received azithromycin, got tested and tested positive. The patient underwent laboratory tests and procedures which included COVID-19 test: positive on an unspecified date. Outcome of the events was unknown. No follow-up attempts are possible. Information about the lot/batch cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034433 same reporter, same drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,,,UNK,,,,,,"['COVID-19', 'Lethargy', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000015,,,F,"Caller got first vaccine dec 28th, tested positive jan 4th; Caller got first vaccine dec 28th, tested positive jan 4th; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 28Dec2020 at Single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got first vaccine on 28Dec2020, tested positive 04Jan2021. The patient wanted to know if she needed to wait to get second dose or if she should wait. The outcome of the event was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000021,MA,62.0,F,"She tested positive for Covid; She tested positive for Covid; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EJ1686), via an unspecified route of administration from 28Dec2020 to 28Dec2020 at SINGLE DOSE for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The nurse that stated that the patient got the first Covid-19 injection on the 28Dec2020 and reported that on the 04Jan2021, she tested positive for Covid. She said that she has been quarantining and was totally asymptomatic. She said that she is due to get the second vaccine on 18Jan2021. The outcome of the events was unknown.; Sender's Comments: Based on the information provided, the lack of efficacy cannot be excluded for vaccine BNT162B2 .",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/04/2021,7.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000031,,,F,"developed pneumonia; tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from contactable nurse, the patient. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 22Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Dec2020, the patient tested positive for COVID-19 and subsequently developed pneumonia on an unknown date. Due to this, the patient did not get her second dose which was scheduled on 12Jan2021 as she was still ill. The clinical outcomes of COVID-19 and subsequently developed pneumonia were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/26/2020,4.0,UNK,,,,,,"['COVID-19', 'Illness', 'Pneumonia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000036,NY,38.0,M,"tested positive for a Sars-Cov-2 infection; tested positive for a Sars-Cov-2 infection; This is a spontaneous report from a contactable consumer (patient). This 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK5730) intramuscular in the left deltoid on 18Dec2020 at the age of 38-years-old at single dose for COVID-19 immunisation. There were no relevant medical history and concomitant medications. On 05Jan2021, the patient tested positive for a SARS-COV-2 infection. The patient was asking how to proceed with getting his second dose; at the time of the report, he was 2 weeks post diagnosis and he was 32 days since his first shot. At the time of the report, the outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,01/05/2021,18.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 1000041,,,U,"received the first dose of the COVID-19 vaccine on 22Dec2020/tested positive after taking the first dose; received the first dose of the COVID-19 vaccine on 22Dec2020/tested positive after taking the first dose; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 22Dec2020 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that the pharmacist understood that the undiluted vials could be stored up to 120 hours in the refrigerator. She mentioned that their vials are already close to 120 hours stored in the refrigerator. She also knows that if you draw it up in a syringe, the vaccine has a 6-hr viability. She wanted to know if the vial expires after 120 hours or it would mean an additional 6 hours on top of the 120 hours. It was reported that ""The allowable time in the refrigerator (5 days or 120 hours), starts when the vaccine is removed from storage under ultra-low temperatures. From the point of dilution, the vaccine may be stored at 2 degrees C to 30 degrees C for up to 6 hours."" also shared extended stabiilty information of diluted vials"". It was then reported that the patient received the first dose of the COVID-19 vaccine on 22Dec2020. However, the patient tested positive after taking the first dose. The pharmacist asked if the patient should be revaccinated with first dose and then wait for the another 2 weeks for the second dose. Pharmacist further asked if not, is it ok giving it at 8 days after the 21 day-interval, how to proceed, and dose the Regulatory recommendations included people who had COVID-19. Outcome of the event was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported ""tested positive after taking the first dose"".",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000045,,,M,"tested positive for Covid after getting the first dose of vaccine; tested positive for Covid after getting the first dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of on 16Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had previously received the first dose of shingles shot as immunization on an unknown date. It was stated that the patient tested positive for COVID after getting the first dose of vaccine in Jan2021. The patient also mentioned that he was scheduled to have a second dose of PFIZER-BIONTECH COVID-19 VACCINE on 06Feb2021 and his second shot of shingles shot on 09Feb2021. Outcomes of the events were unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000046,NJ,86.0,M,"I could not hear anything; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: el8982), via an unspecified route of administration at the left arm on 18Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included hearing problem, CAD and glaucoma. The patient has no allergies to medications, food, or other products. Concomitant medication included tamsulosin, levothyroxine sodium (LEVOXYL), omeprazole, acetylsalicylic acid (BABY ASPIRIN) and astorta. On 19Jan2021, 1 day after injection around 5pm the patient reported to have taken a nap, and when he woke up, he could not hear anything. The patient has a hearing problem only have 10% hearing. He was going to see ENT. The event resulted to doctor or other healthcare professional office/clinic visit. The reporter assessed the event as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 post vaccination. The outcome of the event was not recovered",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/19/2021,1.0,UNK,TAMSULOSIN; LEVOXYL; OMEPRAZOLE; BABY ASPIRIN,,Medical History/Concurrent Conditions: Coronary artery disease (CAD); Glaucoma; Hearing impaired,,,['Deafness'],1,PFIZER\BIONTECH, 1000051,FL,70.0,F,"bad chills/terrible chills; terrible acid reflux for 3 hours; couldn't even walk, she had to crawl and her husband had to walk her around, she couldn't do anything; threw up; very dizzy/dizziness; vertigo; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, unknown expiration), via injection in right arm on 13Jan2021 at a single dose for COVID-19 prevention. Medical history included ongoing vertigo (in car accident a little over 5 years ago, that affected a big nerve in left temple, and so every once in a while she will get vertigo so bad that she falls over), ongoing GERD (from a hiatal hernia; diagnosed many years ago), ongoing high blood pressure diagnosed about 15 years ago, ongoing bad cholesterol diagnosed 10 to 15 years ago, ongoing heart burn, ongoing hiatus hernia, and car accident a little over 5 years ago. Concomitant medications included ongoing omeprazole sodium (OMEPRAZOLE) for GERD, heart burn, and hiatal hernia (started this product at least 10 years ago; takes the product as needed if she is having heart burn or is going to eat spicy food); ongoing vitamin D3 for vitamin supplementation (started product about 8 months ago, because her doctor told her too, she guesses her vitamin was low); ongoing metoprolol for high blood pressure and to prevent stroke (started product at least 15 years ago; her BP could be regular but it could shoot up when she is upset, so she takes this to prevent stroke); ongoing hydrochlorothiazide for blood pressure (started product at least 5 years ago); pravastatin for bad cholesterol (started the product at least 4 or 5 or more years ago); and ongoing acetylsalicylic acid (BABY ASPIRIN) to prevent stroke (has been taking this product forever, at least for 10 years). The patient reported that she received the first COVID shot on 13Jan2021. She was okay on the 13th, 14th, and 15th. However, on the 16th (16Jan2021), she woke up and threw up once and was very dizzy for three days. She mentioned that she had like vertigo, she couldn't even walk, she had to crawl and her husband had to walk her around, she couldn't do anything. She had vertigo (16Jan2021). She was that way on Saturday and Sunday. On Monday, the patient's son took her to acupuncturist for her dizziness and was able to get up fine and walked away. After the acupuncture, she felt fine, like she was all better. On 19Jan2021 (reported as yesterday), she was fine. She woke up at midnight and had terrible acid reflux for 3 hours even though she had hardly eaten. She does take omeprazole for heart burn, and she had taken omeprazole earlier in the day, but it was just coming up, that acid and burning. She drank milk to coat the stomach and it went away at 03:00 AM. She had very bad chills/terrible chills (20Jan2021) and her teeth were chattering, she couldn't even talk, and couldn't control the chills. She is fine now. She clarified that she got vertigo from a car crash years ago and haven't had it in almost a year. Chills are not ongoing at this time, she has not had any for about 4 hours now, and she is hoping she is recovered completely, but it may be too soon to tell. She did not receive other vaccines on the same day as the COVID vaccine. The patient is wondering if all this could be from the vaccine. The patient wanted to know if it is safe to take the second shot. She was scheduled to receive the second dose on 03Feb2021. The patient recovered from the events threw up on 16Jan2021; unable to walk and vertigo on 18Jan2021; dizziness on 19Jan2021; and terrible acid reflux on 20Jan2021. While unknown outcome for chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/16/2021,3.0,UNK,OMEPRAZOLE [OMEPRAZOLE SODIUM]; VITAMIN D3; METOPROLOL; HYDROCHLOROTHIAZIDE; PRAVASTATIN; BABY ASPIRIN,"Blood cholesterol abnormal (diagnosed 10 to 15 years ago.); Blood pressure high (diagnosed about 15 years ago); GERD (GERD from a Hiatal Hernia; diagnosed many years ago); Heartburn; Hiatal hernia; Vertigo (in car accident a little over 5 years ago, that affected a big nerve in left temple)",Medical History/Concurrent Conditions: Automobile accident (a little over 5 years ago),,,"['Burning sensation', 'Chills', 'Condition aggravated', 'Decreased appetite', 'Dizziness', 'Gait disturbance', 'Gait inability', 'Gastrooesophageal reflux disease', 'Loss of personal independence in daily activities', 'Speech disorder', 'Vertigo', 'Vomiting']",1,PFIZER\BIONTECH, 1000052,IL,,M,"he tested positive for COVID-19 between the 1st and 2nd dose of the vaccination schedule; he tested positive for COVID-19 between the 1st and 2nd dose of the vaccination schedule; Fever; This is a spontaneous report from a contactable consumer (patient's wife). A 76-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), intramuscular on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 between the first and second dose of the vaccination schedule. The reporter asked if it would be safe for him to receive the second dose (COVID-19 vaccine) on an unspecified date (reported as tomorrow). He has been fever-free for 5 days. Outcome of the event fever was recovered on an unspecified date in Jan2021 and of the other events was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['COVID-19', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 1000061,,,F,"Test positive for covid; Test positive for covid; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (lot number unknown), via an unspecified route of administration, on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer covid vaccine first dose on 07Jan2021, then she tested positive for covid on 18Jan2021. The patient was scheduled for second vaccine on 28Jan2021. The patient asked if still get 2nd dose on 28Jan or start series again at later date. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/18/2021,11.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000074,OK,80.0,F,"began to run a fever, so she had a COVID test which came back positive; began to run a fever, so she had a COVID test which came back positive; her arm began to be sore; feels pretty crummy; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 07Jan2021 likely around 2pm-ish at a single dose for COVID-19 immunization. Medical history included diabetic from 1993 to an unknown date. There were no concomitant medications. The patient called about the Pfizer BioNTech COVID19 vaccine and says she took the first shot on 07Jan2021, then one week later, 14Jan2021, she began to run a fever, so she had a COVID test on Monday 18Jan2021, which came back positive. She says she has had a fever at the time of report for the 7th day. The patient received the vaccine and doesn't know if she is willing to get the second shot after this. The patient was asking if it could be a false positive, can she take ibuprofen, can she take the second dose and could the vaccine cause coronavirus. She says that she got the first dose of the vaccine, it was injected into her left arm, and it wasn't painful, she felt so good, then night of 07Jan2021 her arm began to be sore, her vaccine arm was now ok, she started feeling sick a week later. She has been taking Tylenol only, since she heard that it is not good to take Ibuprofen. Tylenol EXP: Mar2024, LOT: SEA054, she says that the Tylenol is 325mg, and she has been taking two at a time, she takes it when she needs it for the fever, she tries to space out doses 5-6 hours. Her temperature on morning of 20Jan2021 was the highest it has been, 102.1 degrees Fahrenheit. She says she has kept a log, it has also been 101.4, 100.5, after it started out a week ago at 99.7, 99.1, 99.5, and then on Saturday, unknown date in Jan2021, it started climbing up, it has been 100.4 degrees Fahrenheit last two to three days and higher, she feels pretty crummy. She has had a positive COVID test which she took Monday 18Jan2021 and the results came back morning of 20Jan2021 on the phone, it is unknown which test exactly they used. She says it was the 2-3 day one with a swab, she did her own swabbing and swabbed each nostril with the same swab really well. The events were reported as non-serious. Outcome of the event her arm began to be sore was recovered in Jan2021, for the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Diabetic,,,"['COVID-19', 'Feeling abnormal', 'Malaise', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000079,AZ,,M,"tested positive for the COVID-19 Virus; tested positive for the COVID-19 Virus; This is a spontaneous report from a contactable nurse (patient's wife). This nurse reported similar events for her and her husband. This case refers to the husband. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient tested positive for the COVID-19 virus on an unspecified date. The outcome of the event was recovered on an unspecified date. The wife asked on how the patient should proceed for the second dose (if they will wait for 90 days). Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021034841 Same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000082,,70.0,F,"feels itchy; burning; tingling and paresthesia all over her body; This is a spontaneous report from a contactable physician. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 12Jan2021, and she has had a serious reaction since; she felt itchy, burning, tingling and paresthesia all over her body. She has been on Benadryl for it. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events itchy, burning sensation, paresthesia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/12/2021,0.0,UNK,,,,,,"['Burning sensation', 'Paraesthesia', 'Pruritus']",UNK,PFIZER\BIONTECH, 1000091,,,F,"tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable other hcp. The other hcp reported same events for two patients (herself and her coworker). This is the first of two reports, for herself. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date in Jan2021 (either 06Jan2021 or 07Jan2021) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was calling about herself and another coworker. They both received the first dose of the COVID vaccine either 06Jan2021 or 07Jan2021 and they both tested positive for Covid-19 this past weekend (Jan2021) and reporter wanted to know if they should still get their second dose or what do they recommend for that. Reporter is asymptomatic and currently quarantining. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE due to temporal relationship. There is limited information provided in this report. This case will be reassessed once additional information is available.,Linked Report(s) : US-PFIZER INC-2021072822 Same reporter/drug/AE, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000103,IN,54.0,M,"He had a secondary infection of bronchitis; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; sore arm; headache; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient started to receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration in the right arm on 30Dec2020 14:40 at single dose for COVID-19 immunisation. Medical history included hypothyroidism and blood cholesterol, both ongoing. The patient received the influenza vaccine on 04Nov2020. Concomitant medication included levothyroxine sodium (SYNTHROID), eicosapentaenoic acid ethyl ester (VASCEPA). On 31Dec2020 the patient experienced sore arm and headache with outcome of recovered on 01Jan2021. On 02Jan2021 and 03Jan2021 he felt fine. He had a scratchy throat on Monday 04Jan2021. Tuesday 05Jan2021 he felt like he was getting bronchitis which he got sometimes. Later that evening on 05Jan2021 he had a two degree temperature, chills, and achy muscles. He couldn't get in with the doctor on 05Jan2021, so he had to wait until 06Jan2021 when he went to the respiratory clinic. They did the COVID test on 06Jan2021, but the positive result didn't come back until 07Jan2021. He was just now recovering from it. He had a secondary infection of bronchitis and was given an inhaler.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,PVT,SYNTHROID; VASCEPA,Cholesterol; Hypothyroidism,,,,"['Body temperature increased', 'Bronchitis', 'COVID-19', 'Chills', 'Condition aggravated', 'Headache', 'Myalgia', 'Pain in extremity', 'SARS-CoV-2 test positive', 'Throat irritation']",1,PFIZER\BIONTECH, 1000108,,,M,"felt like his throat was closing up; dizziness; trouble with his vision/couldn't see right; numbness in the face; the feeling of this AE as being ""intoxicated""; 15 minutes after, he started to not feel well/not feeling good at all; was not able to drive; high temperature; having chills; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), via an unspecified route of administration on 20Jan2021 10:30 AM at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient got the Pfizer COVID-19 vaccine today (20Jan2021) at 10:30AM. Within the 15-20 minutes after getting the shot, he felt fine. About 15 minutes after, patient started to not feel well. He said he was not able to drive, he had a high temperature, he was having chills, and not feeling good at all. Patient mentioned that he also had trouble with his vision. Patient also experienced numbness in the face and dizziness. He had an ambulance check him and they told him that his blood pressure was fine and his heart rate was at 92. Patient added that he felt like his throat was closing up. He described the feeling of this AE as being ""intoxicated"". Patient also emphasized that he ""couldn't see right"". Outcome of the events was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/20/2021,0.0,UNK,,,,,,"['Chills', 'Dizziness', 'Hypoaesthesia', 'Impaired driving ability', 'Loss of personal independence in daily activities', 'Malaise', 'Pyrexia', 'Throat tightness', 'Visual impairment']",UNK,PFIZER\BIONTECH, 1000120,,,F,"contracted Covid 07Jan2021; contracted Covid 07Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was unknown), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she received the first dose on 02Jan2021 and contracted Covid 07Jan2021. She was out of isolation since 17Jan2021 and currently have no symptoms. She is scheduled to receive the vaccine this coming Saturday (23Jan2021). The patient wanted to know if she can receive the second dose or should she postpone her appointment. The patient asked what would happen if she decided to get the second dose in 3 months after dose 1 and asked if she would need to start the vaccine series from the beginning. The outcome of the event was recovered on Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE due to temporal relationship. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/07/2021,5.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000122,NY,36.0,F,"hives from the neck to legs; Face redness; tightness in the chest; unable to take a deep breathe; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), intramuscular in left arm on 12Jan2021 11:00 to at a single dose for COVID-19 immunization. Vaccination was done in a hospital. There were no relevant medical history and concomitant medications. On 12Jan2021 11:00, hives from the neck to legs, face redness and tightness in the chest, and was unable to take a deep breathe. The outcome of the events was recovered with sequelae. The events resulted in an emergency room/department or urgent care. Treatment for the events included Benadryl, Ativan, Pepcid, NS Bolus and EpiPen. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested with COVID-19 post vaccination.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of hives from the neck to legs, face redness and tightness in the chest, and was unable to take a deep breathe due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including physical examination with vitals and chest x-ray, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Chest discomfort', 'Dyspnoea', 'Erythema', 'Urticaria']",1,PFIZER\BIONTECH,OT 1000124,,73.0,F,"the thermometer that marked 100�F orally (she says that the fever was higher in the night); States she is shrinking. Weight varies; cough; 86 of oxygen saturation/O2 saturation was anywhere between 86-88; pulse was 133/rapid pulse, it was 133/rapid heartbeat; her breathing was above 94; shooting pain/stabbing pain at the injection site/extremely excruciating stabbing pains in her arm with the shot; shivers; headache/splitting headache; freezing; slight breathing difficulty; slight body aches; Sore arm; Fatigue; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284, expiration date unspecified), via an unspecified route of administration on 15Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included high blood pressure diagnosed 15 years ago, maybe; High cholesterol diagnosed 20 years ago, she doesn't know, reflux diagnosed 20 years ago, maybe more, prediabetes and allergy induced asthma which she carries an inhaler, and she has used it maybe three times a year. Patient reported that she was tested and they don't know for sure, but she reported that she may have allergy induced asthma as she has to take, carries an inhaler, and she has used it maybe three times a year, in the fall when leaves are falling down, the leaves get moldy, and she was driving in her car, or walking in a wooded area, she gets tightness, takes her inhaler and was fine, that's the extent, no other circumstances; fall or she had where a plant was blooming outdoors, she gets tightness, and she took her inhaler, and was good for the next year, so sitting in the environment and nothing further materializes, if she takes the inhaler three or two times a year, considering what other people have, she thought this was insignificant. There were no concomitant medications. The patient reported that she got vaccinated this Friday and had nothing but a sore arm afterwards, on 16Jan2021 and was fine all day, evening, all day Saturday. She just had soreness at the site, she had no redness at the site of injection, but the weird part: she doesn't think anyone would believe, 33 hours later, at midnight, she was still up, on her way to bed, and all of a sudden she experienced extremely excruciating stabbing pains in her arm with the shot, it was stabbing, excruciating, and immediately at the same time, she had shivers/shivered and had a splitting headache, was freezing and had to put socks on, and had noticed very slight difficulty breathing, and since it was midnight, she didn't want to wake up her husband, she dozed off, and was up at 0530. She had body aches, slight, it was the least, but the stabbing stopped in her arm. She slept from 12:30 to 05:30, and the shivering and aches stopped, but the headache was still on, so she took a pill for the headache. She took the thermometer that marked 100F orally; she stated that the fever was higher in the night and she assumed with the shivering, she had a greater fever than 100. Also, the oximeter indicated 133 pulse and 86 of oxygen saturation. By 10:00, it all had resolved. She has an oximeter, and since she still had the feeling of difficulty breathing, she put it on, but her pulse was 133, that was when she was feeling better. It was reported that all symptoms were gone except for rapid pulse, it was 133 and the slight breathing, and her 02 saturation was anywhere between 86-88, it varied, and by 10:00, all issues resolved, her heartbeat was down to normal, her breathing was above 94, or whatever, everything was fine, and has been fine since then. Maybe she had fatigue on Saturday and Sunday, on Sunday was like after the flu, after you finish, you have fatigue and was a little out of it, this was on Sunday. On an unspecified date, the patient stated that she was shrinking and weight varies. Patient stated that the only thing she does have, says she has a cough, but because she needs a drink, she was not sick and she gets to drink water. She felt like the reaction she had was in the limit of a severe allergic reaction due to the rapid heartbeat and her difficulty breathing. She would like to know if there was information about these side effects reported so she can determine if she was going to have the second dose of the vaccine. Outcome of events states she was shrinking, weight varies and cough was unknown; and outcome of the rest of events was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/16/2021,1.0,UNK,,,"Medical History/Concurrent Conditions: Allergic asthma (carries an inhaler, and she has used it maybe three times a year); Blood pressure high (Diagnosed 15 years ago, maybe); Gastrooesophageal reflux (Diagnosed 20 years ago, maybe more); High cholesterol (Diagnosed 20 years ago, she doesn't know); Prediabetes",,,"['Abnormal loss of weight', 'Body height decreased', 'Chills', 'Cough', 'Dyspnoea', 'Fatigue', 'Feeling cold', 'Headache', 'Heart rate increased', 'Injection site pain', 'Oxygen saturation decreased', 'Pain', 'Pain in extremity', 'Peripheral coldness', 'Pyrexia']",1,PFIZER\BIONTECH, 1000133,,,M,"tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for two patients. This is the first of the two reports. A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 31Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. This patient was vaccinated and has tested positive for Covid-19 on an unspecified date, not sure when he tested positive for the Covid-19. He was asymptomatic. It was also reported that he got sick on 03Jan2021. The second dose is due 21Jan2021, is it ok for him to receive it? How long can he wait if he does not get the vaccine at 21 days? The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021035296 same reporter/product, similar events and different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,,,UNK,,,,,,"['COVID-19', 'Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000134,KS,19.0,F,"rashes on arm getting worse and had one on chest and then on legs; I felt like I was gonna pass out and I did it right when I got to my house; I felt like I was gonna pass out and I did it right when I got to my house; She was lightheaded and extremely dizzy; huge headache; arm didn't hurt when she got the shot but 30 minutes later it hurt so bad; throat hurt extremely bad; This is a spontaneous report from a contactable health professional, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 11Jan2021 at 15:00 (at the age of 19-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to latex, oranges, and adhesive. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), hydroxyzine and celecoxib (CELEXA). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Her arm didn't hurt when she got the shot but 30 minutes later, on 11Jan2021 at 15:30, it hurt so bad. On 18Jan2021 at 15:00 (also reported as the Monday of the vaccination), the patient experienced a feeling like she was going to pass out, at cheer practice, and did it right when she got to her house. She was lightheaded and extremely dizzy the whole time at practice and had a huge headache. Also, when she got to practice at on 18Jan2021 at 15:15, she noticed the rashes on her arm getting worse, and on her chest and then on her legs. Then, on an unknown date in Jan2021, her throat hurt extremely bad, so she gargled with salt water and it felt a little better. The patient was not treated for the events ""I felt like I was gonna pass out and I did it right when I got to my house"", ""She was lightheaded and extremely dizzy"", ""huge headache"", ""rashes on arm getting worse and had one on chest and then on legs"" and ""arm didn't hurt when she got the shot but 30 minutes later it hurt so bad""; and was treated for ""throat hurt extremely bad"" as the patient gargled with salt water. Since the vaccination, the patient had been tested for COVID-19 via rapid nasal swab on 18Jan2021 with a negative result. The clinical outcome of ""I felt like I was gonna pass out and I did it right when I got to my house"" and ""arm didn't hurt when she got the shot but 30 minutes later it hurt so bad"" was unknown; of ""She was lightheaded and extremely dizzy"", ""huge headache"", ""rashes on arm getting worse and had one on chest and then on legs"", ""throat hurt extremely bad"" was resolving. Information on the lot/batch number has been requested.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of pass out cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 40.~",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/01/2021,,SEN,ADDERALL; HYDROXYZINE; CELEXA,,"Medical History/Concurrent Conditions: Adhesive tape allergy (allergies: Latex, oranges, and adhesive); Fruit allergy (allergies: Latex, oranges, and adhesive); Latex allergy (allergies: Latex, oranges, and adhesive)",,,"['Dizziness', 'Headache', 'Loss of consciousness', 'Oropharyngeal pain', 'Pain in extremity', 'Rash', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,OT 1000146,NY,,M,"pericarditis; This is a spontaneous from a contactable physician reporting for himself. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231, expiry date unknown) via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 19Jan2021, the patient developed pericarditis. The physician considered it was possible complication from his first dose of the COVID-19 vaccine. The outcome of the event was not reported. His second dose was scheduled for 27Jan2021.; Sender's Comments: Based on the limited information available, causality between event pericarditis and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/19/2021,12.0,UNK,,,,,,['Pericarditis'],1,PFIZER\BIONTECH, 1000147,MI,72.0,F,"go to the bathroom, remember wiping and them my husband standing over me on the floor; Sweating profusel; Product use for unapproved combination; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249) via an unspecified route of administration in the right arm on 19Jan2021 at 09:15 at single dose for COVID-19 immunisation. The patient was not pregnant. She received another vaccine (unspecified) in the left forearm on the same date of BNT162B2. Relevant medical history included allergies to tape and potential basal cell cancer. Concomitant medications included melatonin and multi vitamins. The patient previously received varicella zoster vaccine rge (cho) (SHINGRIX) on 21Dec2020, second dose in the left arm. The patient reported that she felt great after the shot at 9:30 am on 19Jan2021 and, at 13:30, she had a potential basil cell cancer removed, and she felt great. On 20Jan2021, at 1:55 am, she got up to go to the bathroom, she remembered wiping and then her husband standing over her on the floor. On 20Jan2021 at 01:45 am, she was sweating profusely; after a minute, she got herself off the floor, back in bed, and she had no feelings of any illness. The patient did not receive corrective treatments for the reported events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The patient recovered from the events on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,PUB,MELATONIN,,"Medical History/Concurrent Conditions: Adhesive tape allergy; Basal cell carcinoma (at 13:30 on 19Jan2021 she had a potential basil cell cancer removed, felt great.)",,,"['Fall', 'Hyperhidrosis']",1,PFIZER\BIONTECH, 1000149,,54.0,F,"Covid-19 (confirmed by positive COVID-19 test); Covid-19 (confirmed by positive COVID-19 test); This is a spontaneous report from a contactable consumer, the patient. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, on 22Dec2020 (at the age of 54-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she received the first vaccine 22Dec2020. On 10Jan2021, she got COVID-19 and was due to get second shot 2 days later on 12Jan2021. The patient underwent lab tests which included sars-cov-2 test: positive on 10Jan2021. The patient inquired about how long to wait before the second dose after being diagnosed with COVID after receiving the first dose. The clinical outcome of the event COVID-19 was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,01/10/2021,19.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000150,,,U,"tested positive 6 days after receiving vaccine; tested positive 6 days after receiving vaccine; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program Pfizer First Connect. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive 6 days after receiving vaccine on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown. Information about the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1000159,GA,65.0,M,"lost partial vision in my left eye for 10 minutes; tunnel vision; This is a spontaneous report from a contactable consumer reported for himself. A 65-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 14Jan2021 16:00 at single dose, left arm for covid-19 immunization. Medical history reported as none. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Allergies to medications, food, or other products reported as No. The patient experienced ""lost partial vision in my left eye for 10 minutes"" and tunnel vision on 19Jan2021 18:00 with outcome of recovered. On January 19th at 6 pm, the patient had lost partial vision in his left eye for 10 minutes. He had tunnel vision. The patient went to his eye doctor yesterday and his vision was fine with not noticeable issues. No treatment received for the adverse event. Events reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/19/2021,5.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Tunnel vision', 'Visual impairment']",1,PFIZER\BIONTECH, 1000161,CA,,M,"Patient did not receive the 2nd dose as scheduled; Sick; Hearing loss (left ear); This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for himself. A 63 (unit unspecified) male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 25Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hearing loss (left ear) on 27Dec2020 with outcome of recovering. He only had 60% hearing. Therapeutic measures were taken as a result of the event and included treatment with unspecified medication. Now hearing was 90% back. Furthermore, the patient did not receive the 2nd dose on 16Jan2021 as scheduled as he was sick. The reporter stated that he didn't know if hearing loss (left ear) had to do with the vaccine. He asked the doctor, he didn't know either, he said it could be stress or virus. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/25/2020,12/27/2020,2.0,UNK,,,,,,"['Deafness unilateral', 'Malaise']",1,PFIZER\BIONTECH, 1000165,,39.0,M,"chills, muscle pain at site of injection and generally, fatigue, headache, woke from sleep at 2 AM, continued through that day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/04/2021,1.0,MIL,pantoprazole 40mg,none,GERD,,none,"['Chills', 'Fatigue', 'Headache', 'Injection site pain']",2,MODERNA,IM 1000167,,,M,"My nose started bleeding this afternoon about an hour ago/start walking it starts bleeding again; This is a spontaneous report from a contactable consumer reported for himself. This male consumer of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 14:00 at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The consumer reported nose started bleeding in the afternoon about an hour before on 21Jan2021. When the consumer start walking it started bleeding again. The consumer was on clopidogrel bisulfate (PLAVIX). The outcome of the event was unknown. The event was non-serious. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/21/2021,1.0,UNK,,,,,,['Epistaxis'],UNK,PFIZER\BIONTECH, 1000169,,50.0,F,Pain at the injection site that radiated down the arm and up the neck. Body aches inside and out. Restlessness. All for about 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,MIL,Hydrochlorathiazide,None,None,,Raw almonds,"['Injection site pain', 'Neck pain', 'Pain', 'Pain in extremity', 'Restlessness']",1,MODERNA,IM 1000170,FL,73.0,M,"diagnosed with pneumonia; This is a spontaneous report from a contactable consumer via Pfizer Sponsored Program. A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 at single dose for COVID-19 immunisation at the age of 73-year-old. Lot number was EL1284. There was no medical history nor concomitant medications. The patient experienced pneumonia on 18Jan2021. Pneumonia was diagnosed at check up on 25Jan2021. They were not thinking patient got the pneumonia after the vaccine, they did not know if he had the pneumonia already or not at the time of vaccination. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/18/2021,6.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Pneumonia'],1,PFIZER\BIONTECH, 1000172,CT,55.0,F,"Immediate rapid swelling at injection site (golfball-sized within a minute), fever 101, headache, injection site pain, myalgias",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/03/2021,0.0,PVT,"Synthroid, Diltiazem, Lexapro",None,"Hypothyroidism, Hypertension, Depression",,Hazelnuts,"['Headache', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Pyrexia']",2,MODERNA,IM 1000174,NY,,M,"dementia; contracted the covid virus; contracted the covid virus; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's wife) reported that a male patient of an unspecified age received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), with first dose in Dec2020 and with second dose on 19Jan2021, both via an unspecified route of administration at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received BNT162B2 3 weeks ago and got second dose on 19Jan2021, patient had dementia and contracted the COVID virus on 20Jan2021, patient had exposed to COVID 24-48 hours by a healthcare professional in the facility. The outcome of events was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,01/20/2021,50.0,UNK,,,,,,"['COVID-19', 'Dementia', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 1000175,VA,38.0,F,"Eight days after injection, I got a hard, red, swollen, itchy bump at injection site. It was a 4 inch square that was warm to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/29/2021,8.0,PHM,"Vitamin C, Vitamin B, Zinc",none,Hidradenitis Suppurativa,,none,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 1000185,,,M,"Had a stroke; This is a spontaneous report from a contactable consumer via Pfizer-sponsored programs. A male patient (reporter's husband) of an unspecified age received first single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of Covid vaccine on an unspecified date (Friday) at 12:35 PM, and had a stroke on Saturday morning at 10:30AM and was confined at the hospital (date/s unspecified) at the time of reporting. Reporter asked if there was any correlation or any fact sheets available with the vaccine and the stroke that happened to the patient. The outcome of the event was unknown. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,['Cerebrovascular accident'],1,PFIZER\BIONTECH, 1000186,,,U,"patient bled, and a proportion of vaccine in the syringe was not administered; patient bled, and a proportion of vaccine in the syringe was not administered; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. The pharmacist had a question regarding incomplete administration of 2nd dose of bnt162b2. While one patient was given a vaccine, patient bled, and a proportion of vaccine in the syringe was not administered on an unspecified date. The pharmacist asking was there any information about giving a third dose to those who received invalid second dose. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Incorrect dose administered', 'Underdose', 'Vaccination site haemorrhage']",2,PFIZER\BIONTECH, 1000191,CA,47.0,F,"tested for antibodies, and does not have any; States her second dose was on 05Jan2021, that was day number 18 after the first one.; States her second dose was on 05Jan2021, that was day number 18 after the first one.; This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist (patient). A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 05Jan2021 at single dose (reported as 0.3, unit not provided) for COVID-19 immunisation, by injection to left arm. Medical history was none. Concomitant medications included levothyroxine sodium (SYNTHROID). Historical vaccine included first dose of BNT162B2 on an unknown date for COVID-19 immunisation. The patient states her second dose was on 05Jan2021, that was day number 18 after the first one. On 18Jan2021 the patient was tested for antibodies, and does not have any. She was expecting to have antibodies. She is not sick, she did not get sick, but because she didn't have antibodies it is upsetting, but there is nothing going on with body because she doesn't have the antibodies. Calling to find out what she should do now, if she needs to be revaccinated. The event was reported serous as medically significant. Outcome was not recovered. Method of assessment: Global Introspection was related, there is no reason why she wouldn't develop antibodies normally.; Sender's Comments: The 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unknown date, and then received second dose on 05Jan2021, that was day number 18 after the first one. On 18Jan2021 the patient was tested for antibodies, and does not have any. There is possibility of false negative COVID-19 antibody test. The exact reason was unknown. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,UNK,SYNTHROID,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Antibody test negative', 'SARS-CoV-2 antibody test negative']",2,PFIZER\BIONTECH, 1000193,,,F,"Diverticulitis; little bit of pain; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got her first shot of covid vaccine, sometimes she have Diverticulitis a little bit of pain and she wanted to find out if it's ok to take antibiotics and also get the second shot on the 28th. The outcome of the events was unknown. Information on the Lot/Batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Diverticulitis', 'Pain']",1,PFIZER\BIONTECH, 1000198,,,U,"Tested positive for COVID in between the doses for the vaccines; Tested positive for COVID in between the doses for the vaccines; This is a spontaneous report from a Pfizer sponsored program. A contactable registered nurse (not the patient) reported a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; COVID Vaccine a Pfizer product; lot number: EK9231) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter added they were exposed before getting it and did not realize that they were exposed. The patient was tested positive for COVID in between the doses for the vaccines, on an unspecified date. She was wondering what we suggest they do with the second dose. The outcome of event was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Exposure to COVID-19,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000199,NY,56.0,M,"positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a Pfizer-sponsored program from a contactable physician (patient). A 56-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1284), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient had a PCR test on 12Jan2021 and was COVID-19 positive, asymptomatic. The patient had a rapid test on 14Jan2021 and came out negative. The doctor was asking if he can be able to get the second vaccine a longer than 3 weeks which is in the 6th week, asking if it could make a difference since he was tested positive. The outcome of the events was recovered on 14Jan2021.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 30Dec2020, and a PCR COVID-19 test positive on 12Jan2021, asymptomatic. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection. Further information is needed for a full meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/12/2021,13.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000205,TX,,F,"acting weird and wouldnt eat; UTI; Aspirations phenomena; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A female patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter was calling about mother. Said Mom is in E.R. Had received covid vaccine on Thursday. Friday she was ok. Saturday mom was acting weird and wouldn't eat. Saturday night she was thrashing around and wouldn't settle down so they took mom to E.R. was diagnosed with Aspirations phenomena and UTI. Treated the UTI then put her in nursing home. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/01/2021,,UNK,,,,,,"['Abnormal behaviour', 'Food refusal', 'Pneumonia aspiration', 'Restlessness', 'Urinary tract infection']",UNK,PFIZER\BIONTECH, 1000206,PA,49.0,F,"Elevation of Blood pressures proceeded with high 155/95; heart flutter; extreme breast tenderness; axillary swelling; felt general unwell feeling; This is a spontaneous report from a contactable healthcare professional reporting for self. This 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EL0140) via intramuscular on 18Dec2020 12:00 PM at right arm at single dose for COVID-19 immunization. Medical history included known allergies: cinnamon. Patient did not have COVID prior vaccination. Concomitant medications included cyanocobalamin (B12), zinc, 4-(4-hydroxyphenyl)butan-2-one, crocus sativus, magnesium oxide (BELL DE NUIT PRECIOUS MAGICAL). It was reported that first day approx 6 hours after injection patient felt general unwell feeling, next day (19Dec2020) extreme breast tenderness and initiation of axillary swelling. At day 10 post injection (28Dec2020) she experienced some type of heart flutter. Elevation of Blood pressures proceeded with high 155/95 on unspecified date. PCP visit with normal EKG and blood work following week. BP in office 135/85 (from memory). Patient did not receive second dosage at day 21 and BP has currently returned to normal this a.m. (20Jan2021) 117/68. There was no treatment received for events. Patient did not test COVID post vaccination. The outcome of events was recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,B12 [CYANOCOBALAMIN]; ZINC; BELL DE NUIT PRECIOUS MAGICAL,,Medical History/Concurrent Conditions: Spice allergy (known allergies cinnamon),,,"['Blood pressure increased', 'Blood test normal', 'Breast tenderness', 'Cardiac flutter', 'Electrocardiogram normal', 'Incorrect dose administered', 'Malaise', 'Oedema peripheral']",1,PFIZER\BIONTECH,OT 1000207,MN,32.0,F,"cellulitis in right arm below injection site; fever; headache; chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 11Jan2021 at 07:45 AM at a single dose for COVID-19 immunization in a hospital. Medical history reported as none. The patient has no known allergies. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration) on 23Dec2020 at 07:45 AM in left arm for COVID-19 immunization. Concomitant medications included dicyclomine; and unspecified birth control and multivitamin. The patient experienced fever, headache, chills, fatigue, and then got cellulitis in right arm below injection site following second dose of COVID vaccine on 14Jan2021 at 12:00 PM. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient received antibiotics (Keflex) as treatment for the events. The patient recovered from the events in Jan2021. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Vaccination site cellulitis cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/14/2021,3.0,PVT,DICYCLOMINE,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Fatigue', 'Headache', 'Injection site cellulitis', 'Pyrexia']",2,PFIZER\BIONTECH, 1000209,NY,49.0,F,"was supposed to get the second dose yesterday 19Jan2021 but location is closed/ could get it up to the 26Jan2021; paralysis of the chin and half of the face; and around the mouth; This is a spontaneous report from a contactable consumer report for self. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm on 29Dec2021 20:00 PM for COVID-19 immunization. Medical history included ongoing severe migraines. None family history. There were no concomitant medications. No Prior Vaccinations within 4 weeks. After an hour she had paralysis of the chin and half of the face; and around the mouth. It only lasted a few minutes, like 10 minutes and then it went away, she was fully recovered. She did not got to a doctor or the ER. Adds she was supposed to get the second dose yesterday 19Jan2021 but she has to go to another location as that location is closed. They told her she could get it up to the 26Jan2021 and then it would be more problematic to get. The event outcome was recovered on 29Dec2020. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,,Migraine,,,,['Facial paralysis'],UNK,PFIZER\BIONTECH, 1000210,IN,34.0,F,"patient was positive; patient was positive; This is a spontaneous report from a contactable nurse. A 34-year-old female patient (nurse's daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EK9231), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history was none. There were no concomitant medications. The nursed reported that ""The patient was positive, the whole family had COVID and they all came down which was about the same time which was 29Dec. She was treated in the ER with steroids and since that point we have all recovered until she went for the 2nd dose. Probably close to 10 days ago, they did do some lab work at the hospital"". The outcome of events was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['COVID-19', 'Laboratory test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000212,WI,38.0,M,"typical Bell's Palsy; right side facial pain near the anterior right ear and traveling down the facial cranial nerve from that area to his jaw; right side facial pain near the anterior right ear and traveling down the facial cranial nerve from that area to his jaw; Weak feeling coming from the jaw; This is a spontaneous report from a non-contactable nurse (wife). A 38-year-old male patient (husband) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3248 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 18:00 (vaccine location: left arm) at single dose for COVID-19 immunisation. The patient's medical history included hypogammaglobulinaemia, from years low IGA, chickenpox and shingles in the past. The concomitant medications were not reported. No history and additional vaccines administered on same date. On 20Jan2021 when patient woke up, right now at 09:21 AM, he noticed right side facial pain near the anterior right ear and traveling down the facial cranial nerve from that area to his jaw. Reporter stated this was typical Bell's Palsy and the usual treatment is the same as for herpes zoster; steroids and antivirals is the recommended treatment. Reporter is planning to call the doctor as she feels he needs treatment right away and she will get the doctor to prescribe this treatment. Patient has a weak feeling coming from the jaw. Patient had a history of chicken pox and chronic herpes zoster but this was the first time he had had Bell's Palsy. States the effects are persisting and medically significant. Patient was scheduled for the second dose 09Feb2021. Wanted to know about if patient should get the second dose of the vaccine. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/20/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Chickenpox; Hypogammaglobulinaemia; IgA decreased; Shingles,,,"['Blood immunoglobulin A decreased', 'Facial pain', 'Facial paralysis', 'Facial paresis', 'Pain', 'Pain in jaw']",1,PFIZER\BIONTECH, 1000213,AZ,52.0,F,"tested for COVID and result came out positive/ body ache, fever, headache and cough; tested for COVID and result came out positive/ body ache, fever, headache and cough; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration, on 24Dec2020 at single dose as first dose, on left deltoid on 14Jan2021 as second dose at single dose to protect patient from COVID. Medical history included prediabetes and blood pressure high. Concomitant medication included metformin for prediabetes, losartan for blood pressure high. The patient's second vaccine (COVID 19 Vaccine) was just past this 14Jan2021. Then she had a lot of symptoms on 14Jan2021, the patient had like body ache, fever, headache and cough. The patient started to have suddenly with the side effects from the vaccine and then it was fine until yesterday and then she had to go in and get tested for COVID because she had never tested positive and her result came out this morning positive in Jan2021. The patient received Tylenol as treatment. The outcome of events was unknown.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the second vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/14/2021,0.0,UNK,METFORMIN; LOSARTAN,,Medical History/Concurrent Conditions: Blood pressure high (Verbatim: Blood pressure high); Prediabetes (Verbatim: Prediabetes),,,"['COVID-19', 'Cough', 'Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 1000214,NC,,F,"Tested positive for the COVID-19; Tested positive for the COVID-19; Headache; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect via a contactable consumer (patient) reported for herself. A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got her first dose of this Vaccine date is 29Dec2020 and now she had tested positive for the COVID-19, so she wants to know if what to do if she should take the second dose which is scheduled 19Jan2021. Physician confirmed it was COVID-19 Vaccine of Pfizer. She had got a headache. Events outcome was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,,,UNK,,,,,,"['COVID-19', 'Headache', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000215,SD,45.0,F,"impairing her from driving/ bothering her while driving; panic; nauseous; increasingly more and more dizziness with visual disturbances; increasingly more and more dizziness with visual disturbances/She feels things are moving that aren't; This is a spontaneous report from a contactable physician, the patient. A 45-year-old female physician received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK9231, Expiry: Apr 2021), intramuscularly in the left deltoid on 30Dec2020 at 16:30 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included heartburn. Concomitant medications included (dexlansoprazole) DEXILANT for heartburn from an unspecified date (reported as a year and a half). The patient did not receive any other vaccinations within 4 weeks prior to the vaccine. On 31Dec2020, the patient experienced dizziness with visual disturbances. She was having increasingly more and more dizziness with visual disturbances where today (20Jan2021) she felt nauseous from that. It was impairing her from driving because she felt things were moving that weren't and made her panic on the interstate, as of an unspecified date. It. Initially it was bothering her while driving, but now she noticed it while sitting at her desk or when she ate. It was all the time now. The reporter assessed the events ""increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't"" as being between disabling and medically significant. The patient did not visit the emergency room or a physician's office, although stated it probably did require it. The patient queried whether to receive the second dose today as her symptoms were worsening. The clinical outcome of ""increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't"" was not resolved, and of nauseous, ""impairing her from driving/ bothering her while driving"" and panic were unknown.; Sender's Comments: Based on a compatible temporal relationship causality between events dizziness with visual disturbances and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/30/2020,12/31/2020,1.0,PVT,DEXILANT,,Medical History/Concurrent Conditions: Heartburn,,,"['Dizziness', 'Impaired driving ability', 'Nausea', 'Panic reaction', 'Visual impairment']",UNK,PFIZER\BIONTECH,OT 1000216,,81.0,M,"Pneumonia; Eosinophil count high; allergic reaction; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had his first vaccine dose on 04Jan, then 7 days later he was in the hospital with a really high eosinophils count and infiltrate in his lungs, they did a CAT scan, and he had pneumonia in there. Patient's wife said that he was in the hospital for three days for Pneumonia, and now he was out of the hospital and he was supposed to get his second dose of the vaccine on the 25th. She would like to know if her husband should have the second dose, since she didn't know if the pneumonia was caused from the vaccine for sure, it could be an allergic reaction for the vaccine since his count was 22.2 for absolute eosinophils and that was down now to 2.4. She would like to know if it was safe for him get the second dose. She said her husband was still coughing and she didn't know, she was afraid for him to get it. The patient underwent lab tests and procedures which included a CAT scan in Jan2021 and he had pneumonia in there , absolute eosinophils: 22.2 (Eosinophil count high) in Jan2021, absolute eosinophils: 2.4 in Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/04/2021,01/01/2021,,UNK,,,,,,"['Computerised tomogram thorax abnormal', 'Cough', 'Eosinophil count increased', 'Hypersensitivity', 'Lung infiltration', 'Pneumonia']",1,PFIZER\BIONTECH, 1000217,NC,94.0,F,"Disoriented; Urinary tract infection; Shingles/rash; Complaining of pain and burning; Complaining of pain and burning; she was not feeling that well; lose her mental faculties; This is a spontaneous report from a contactable pharmacist. A 94-year-old female patient (reporter's mother) receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 07Jan2021 (around 3:15 PM to 3:20 PM) at 0.3 mL, single (0.3ml dose injection in right arm) for COVID-19 immunization. Medical history included blood pressure, cholesterol, blood thinner and fluid. The patient historical vaccine included varicella zoster vaccine live (ZOSTAVAX) for immunization. There was no history of all previous immunization with the Pfizer vaccine considered as suspect as this was the first dose. The patient had no prior Vaccinations within 4 weeks. Concomitant medications included ongoing apixaban (ELIQUIS) for blood thinner, ongoing furosemide (LASIX) for fluid, valsartan for blood pressure, ongoing pravastatin for cholesterol. The reporter was calling because her mother had the COVID-19 Vaccine on 07Jan2021, it was on a Thursday. By that Friday (08Jan2021) she was not feeling that well. Caller stated she did not know if what occurred had any correlation to the vaccine, but she wanted to report these details in case this started to be came a problem. Her mother is 94 years old and was in very good shape. However, now she was in the hospital completely disoriented. Since getting the vaccine she had subsequently broke out with shingles two days after getting the vaccine on 09Jan2021. Caller reiterated she was not saying this had anything to do with the vaccine, but she just wanted to reported these events. Caller initially stated it was unknown why patient was admitted to the hospital. She went on to explain her mother, the patient, was complaining of pain and burning. She started complaining of this pain and burning in the evening like around 5PM (on 08Jan2021 17:00). She later broke out into shingles. Caller mentioned patient has not had the SHINGRIX vaccine yet. However, she did have the older vaccine, ZOSTAVAX. Caller confirmed patient received the ZOSTAVAX years before. Patient went to the Emergency Room the first time on 09Jan2021 due to complaining of pain and burning and they could not find anything wrong with her. They checked her vitals and ran several tests and it all came back fine. They then sent her home. Patient went back to the Emergency Room on 10Jan2021 and completed another battery of test, labs, checked vitals, had chest x-ray, and cat scan at this time they could not diagnose with Shingles. On 11Jan2021, the patient had an appointment with her Primary Doctor and he did not find anything wrong. Patient came home with caller's sister and she was helping her get undressed. That was when the sister noticed a rash on the patient's body. The rash broke out on her body on Monday 11Jan2021. They tried to call the doctor that night, but did not get a response. On Tuesday 12Jan2021 they took the patient to urgent care and that was when she was formally diagnosed with Shingles. She was started on medication for the Shingles, Acyclovir, and sent home. They also thought she had a slight Urinary Tract Infection. She was started on CIPRO for the urinary tract infection. Patient was home for a couple of days in Jan2021 and she was not getting any better. She was then starting to lose her mental faculties. They thought this was from the urinary tract infection. Caller clarified the patient was then admitted to the hospital on 16Jan2021 due being disoriented. For causality assessment, it was mentioned that it is so coincidental this happened right after getting the vaccine. She was healthy and then it was like a snowball. The outcome of the events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/07/2021,01/01/2021,,PUB,ELIQUIS; LASIX [FUROSEMIDE]; VALSARTAN; PRAVASTATIN,,"Medical History/Concurrent Conditions: Blood disorder; Blood pressure abnormal; Cholesterol; Disorders of fluid, electrolyte and acid-base balance",,,"['Burning sensation', 'Chest X-ray normal', 'Computerised tomogram normal', 'Disorientation', 'Herpes zoster', 'Laboratory test normal', 'Malaise', 'Pain', 'Rash', 'Urinary tract infection']",1,PFIZER\BIONTECH, 1000218,LA,87.0,F,"rash that looks like measles; rash on right side that goes around to back looks like diaper rash; This is a spontaneous report from a contactable pharmacist. An 87-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK9231), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient stated she had this injection 08Jan2021, states the following Thursday, 14Jan2021, she broke out with 2 different reactions, a rash that looks like measles all over, the second reaction is part on her back looks like a little kid has not had their diaper changed, like diaper rash, like half a belt from the right side to the back. States she is very concerned, the patient went to a dermatologist who she had a lot of faith in, doctor met her at the door, read about it but has never seen a reaction like this. States that they injected her with something and it worked in two different places. States she did a biopsy on her hip and took movies to show her students, called her and stated she need to report this event. The patient states she wants to know if she should get the second vaccine. States she used to be 5 foot 2 inches, shrunk prior to vaccine. The patient last night to report but she could not get through. Stated she got injection on right arm. The patient stated the rashes are trying to improve. States the rash that looks like measles started on the right side and now is all over. The patient stated she is allergic to bromines and swims in a bromine salt water heated swimming pool and this has nothing to do with it but the point she is saying is that she says your allergic to things and then not have reactions and sometimes you do. Both events were serious with criteria of medially signicant. The patient underwent lab tests and procedures which included biopsy: unknown results, body height: 5 foot 2 inches (States she used to be 5 foot 2 inches, shrunk prior to vaccine). The outcome of the event rash that looks like measles was not recovered, while the outcome of the other event was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/14/2021,6.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Anxiety', 'Biopsy', 'Body height decreased', 'Dermatitis diaper', 'Rash', 'Roseola']",UNK,PFIZER\BIONTECH, 1000219,FL,67.0,F,"one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she started feeling a little warm; Low grade fever; Chills; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302), intramuscularly on 19Jan2021 11:03 on right arm at single dose for COVID-19 immunization. Vaccination Facility Type was at Clinic. Medical history included just had rotator cuff repair surgery last Thursday (11Jan2021), pain, muscle relaxer. Concomitant medications included acetaminophen; hydrocodone as pain medicine, methocarbamol as muscle relaxer. Historical Vaccine included first dose of BNT162B2 (Lot number: EK9231) intramuscularly on 28Dec2020 at 9:52 am for COVID-19 immunization on right arm and experienced right arm soreness at the injection site. It was reported that last night (19Jan2021) she had a low grade fever and chills, then it went away, she was not having the chills earlier today and the fever went away. The fever had come back and she was chilled even though it was hot. She tested negative for coronavirus that Monday (08Jan2021) prior to the surgery. She was being told that one of the nurses at the outpatient clinic where she worked was positive for covid. She clarified that the fever and the chills go together and started last night. The fever did get better and she was not feeling feverish or chilled during the day. About 2 or 3 hours ago (20Jan2021) she started feeling a little warm, nauseated and she checked her temperature 30 minutes ago and it was 99.4. She always run low and did not have a fever. No treatment received for all events. The outcome of event low grade fever was resolving, outcome of events chills and nauseated were not resolved, outcome of other events were unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events low grade fever, chills and nausea cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,OTH,ACETAMINOPHEN;HYDROCODONE; METHOCARBAMOL,,Medical History/Concurrent Conditions: Muscle disorder; Pain; Rotator cuff repair (rotator cuff repair surgery last Thursday),,,"['Chills', 'Feeling hot', 'Injection site pain', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,OT 1000226,GA,86.0,F,"volvulus; volvulus and needed surgery followed by further ischemia; This is a spontaneous report from a contactable physician. An 86-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) intramuscularly on 19Jan2021 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient developed volvulus and needed surgery followed by further ischemia and at end of life. The events onset date reported as 27Jan2021. Patient had 3days hospitalization and died eventually. It was unknown if an autopsy was performed. Information about lot/batch number has been requested.; Sender's Comments: Very limited information was provided in this report. No relevant information regarding the clinical course of the events, the patient's underlying medical conditions were mentioned. Based on the information currently available, lacking any other alternative explanations as so far, the reported volvulus and Intestinal ischaemia are managed as related to COVID-19 vaccine, BNT162B2, for reporting purpose, only. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.; Reported Cause(s) of Death: volvulus; ischemia",Yes,,Not Reported,Yes,3.0,Not Reported,N,01/19/2021,01/27/2021,8.0,UNK,,,,,,"['Death', 'Ischaemia', 'Surgery', 'Volvulus']",1,PFIZER\BIONTECH,OT 1000227,CA,67.0,M,"heart attack; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (BNT162B2, lot # EL9263) at single dose at left arm on 23Jan2021 14:15 for Covid-19 immunisation. Medical history included hypertension, high cholesterol. No known allergies. The patient had not experienced Covid-19 prior vaccination. There were no concomitant medications. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 24Jan2021 06:00, the morning after he received the COVID-19 vaccine, he had a heart attack. The patient was hospitalized for heart attack for 2 days and evet was considered life threatening. The doctor placed 2 stents in his arteries. The patient underwent lab tests and procedures which included Sars-cov-2 test: negative on 24Jan2021.",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/23/2021,01/24/2021,1.0,PUB,,,Medical History/Concurrent Conditions: High cholesterol; Hypertension,,,"['Coronary arterial stent insertion', 'Myocardial infarction', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH, 1000228,NV,40.0,M,"dead; Collapsed; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; This is a spontaneous report from a contactable nurse. A 40-year-old male patient receive first dose of bnt162b2 (Lot number: EK9231, Brand: Pfizer), intramuscular in left arm on 21Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included immunocompromised w/ reportable conditions from an unknown date and unknown if ongoing, positive for Covid in September from Sep2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced dead, collapsed on 26Jan2021. Therapeutic measures were taken as a result of collapsed. The outcome of collapsed was unknown. The patient died on 26Jan2021. It was not reported if an autopsy was performed. Received Covid vaccine here on 21Jan2021, was at work on 26Jan2021 and collapsed, no known complaints at the time, CPR (cardiopulmonary resuscitation) was initiated immediately, transported to ER (Emergency room) and pronounced dead. Unknown if other vaccine in four weeks. The patient had COVID prior vaccination. Unknown If COVID tested post vaccination.; Sender's Comments: Based on the information currently provided, the patient was immunocompromised and had prior COVID infection. The death and syncope more likely are associated with the patient underlying medical conditions. More information such medical history, concomitant medications, treatment indication and event term details especially death cause and autopsy results are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Dead",Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,OTH,,,Medical History/Concurrent Conditions: COVID-19; Immunocompromised,,,"['Death', 'Resuscitation', 'Syncope']",1,PFIZER\BIONTECH,OT 1000231,TX,41.0,F,"currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous report from a contactable physician report for self. This 41-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Breast cancer (remission, 15 years ago), GERD, Hyperlipidemia. Concomitant medication not reported. Patient previously received second dose of Gardasil vaccine on 16Dec2020 at left arm and first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 08:15 AM at left arm. Five days after 2nd covid vaccine (on 25Jan202021 01:00 PM), patient started experiencing excruciating pain along the plantar aspects of both feet. This, with numbness and tingling ascended upwards (in a matter of hours) to lower back and arms. Patient went to local emergency room and was later transferred to (Institute name) for higher level of care. She was currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy. This is a GBS-like illness. Very debilitating, due to pain. No motor deficits yet. Hoping the IVIG stops the Demyelinating process in its tracks. The events resulted in hospitalization for 6 days. Patient received Nasal Swab covid test date on 25Jan2021 with result of ""Negative"". The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported event acute inflammatory demyelinating neuropathy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,6.0,Not Reported,N,01/20/2021,01/25/2021,5.0,WRK,,,Medical History/Concurrent Conditions: Breast cancer; GERD; Hyperlipidemia,,,"['Asthenia', 'Guillain-Barre syndrome', 'Hypoaesthesia', 'Immunoglobulin therapy', 'Pain', 'Pain in extremity', 'Paraesthesia', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH, 1000233,,,M,"just died; This is a Spontaneous report from a Pfizer Sponsored Program from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient just died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: just died",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],UNK,PFIZER\BIONTECH, 1000385,FL,69.0,F,Client felt nauseous and had palpitation. Paramedics assess client on site. Client was released at 10.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/03/2021,02/03/2021,0.0,PUB,Client unsure of medications currently taking.,,,,,"['Nausea', 'Palpitations']",1,PFIZER\BIONTECH,IM 1000388,SD,30.0,M,"Fever, tachycardia, hypotension, diffuse urticaria",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/04/2021,2.0,PVT,,,,,,"['Full blood count', 'Hypotension', 'Metabolic function test', 'Pyrexia', 'Tachycardia', 'Urticaria']",2,MODERNA,IM 1000392,IL,35.0,U,"SEVERE FEVER , WEAKNESS , AND ACHES THAT LASTED ABOUT 20 HOURS.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/19/2021,01/20/2021,1.0,UNK,,,,,,"['Asthenia', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 1000394,IN,67.0,F,"Chills, temp 101",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,PVT,"Baby asa,bioten,allergy pill,valsartan,melixicam,alendronate sodium.",None,"High b/p, high cholesterol",,None,"['Chills', 'Pyrexia']",UNK,MODERNA, 1000398,,42.0,F,Diarrhoea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/03/2021,4.0,WRK,Levothyroxine,,Hypothyroid coeliac,,,['Diarrhoea'],1,PFIZER\BIONTECH,IM 1000402,NY,35.0,F,"Fever, muscle aches, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/04/2021,1.0,PVT,"Metoprolol, multivitamin, iron, vitamin c, biotin, collagen, vitamin d, magnesium",None,Tachycardia,,Reglan,"['Headache', 'Myalgia', 'Pyrexia']",2,MODERNA,IM 1000405,IA,32.0,F,Face and arm on the side COVID vaccine given started tingling and got warm right away then had numbness and tingling after. For the first 15 mins also had heart palpitations. 12 hours later after waking up face sensation was dull and improved over the night.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,"multivitamin, vitamin C, Vitamin D",none,none,,NKA,"['Feeling hot', 'Hypoaesthesia', 'Palpitations', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 1000408,,38.0,F,"Headache, Soreness and bump at injection site, congestion, some chills, and tiredness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,MIL,"L-Lysine, Multi-Vitamins",None,PTSD,,None,"['Chills', 'Fatigue', 'Headache', 'Injection site mass', 'Injection site pain', 'Nasal congestion']",2,MODERNA,SYR 1000412,VA,24.0,F,"7 days after the shot, the arm that received the shot got very itchy, irritated, and a little red. It is currently 8 days after the shot and my arm is still very itchy and feels a little swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/03/2021,7.0,PVT,"Spirolactone, gummy vitamins, vitamin C",None,None,,None that I am aware of.,"['Erythema', 'Peripheral swelling', 'Pruritus', 'Skin irritation']",1,PFIZER\BIONTECH,SYR 1000415,WV,55.0,M,"Light headed and aches within two hours. At 2am next morning, I could hardly stand due to muscle pain and weakness, neck to toes, with associated nausea and low-grade fever of 99/100 the rest of the day. I took Advil and Tylenol every 4-6 hours. Some pain and weakness and nausea remain on 2/4/2021 but fever is gone and feeling well enough to return to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/02/2021,02/03/2021,1.0,WRK,Metoprolol Limiter Low dose aspirin,Diverticulosis,Diverticulitis,,None,"['Asthenia', 'Dizziness', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,IM 1000418,PR,47.0,M,Pleuritic chest pain. Admitted due to acute pericariditis. Course complicated with new onset atrial fibrillation.,Not Reported,,Yes,Yes,5.0,Not Reported,Y,12/15/2020,01/04/2021,20.0,PVT,None,None,None,,Acetaminophen Aspirin Dextromethorphan Shellfish,"['Atrial fibrillation', 'Chest X-ray abnormal', 'Chest X-ray normal', 'Echocardiogram normal', 'Pericarditis', 'Pleural effusion', 'Pleuritic pain']",UNK,PFIZER\BIONTECH,SC 1000419,,29.0,F,Left half of face (same side as injection) from chin/neck to scalp was numb for approximately 8 hours. Felt very similar to the numbness of after dental work. Did NOT have face paralysis like that of Bell's Palsy just face numbness. After approximately 8 hours feeling was restored. As of 2+ weeks later no lasting effects.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,MIL,Nexium,,"ADHD, GERD","Flu Vaccine- Rash for 2+ wks, arm weakness for 1-2 month. Since Age 23 and on.",Penicillin,['Hypoaesthesia'],1,PFIZER\BIONTECH,SYR 1000421,FL,72.0,F,Chills and headache the night of the injection. Next morning at 6:00 was sitting up in bed and became unconscious and unresponsive to painful stimulus. Called 911 medics. After about 20 minutes - started to regain conscious. At that point Bp was 50/40. Taken to Hospital . Vomiting and Diarrhea. Was given 1 bag IV saline and adavan. Release after 4 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/02/2021,1.0,PUB,Desmopressin .1mg AM & PM Levoxyl 75 mcg daily Lexipro 10mg 1/day Gabapentin 2 @300mg Centrum Gummies vitamins ? bid Phillips Fiber Gummies 4/day Posture-D - bid Botox ? bladder injections 10/8/20 Prolia 60ml twice per year 1/5/21 Vala,,"Diabetes INCIPITUS hypo-thyroid (surgically removed 2000) over active bladder NEUROENDOSCOP,EXC,PIT TUM,TRANSNAS/SPHEN 3/10/2020",1/4/21 Moderna - red rash on Right Arm,none,"['Chills', 'Diarrhoea', 'Full blood count', 'Headache', 'Loss of consciousness', 'Unresponsive to stimuli', 'Vomiting']",2,MODERNA,IM 1000423,FL,41.0,F,"Within 12 hours of receiving vaccine I began to feel fatigue in my muscles and a mild headache. The next morning I experienced brain fog, inability to formulate thoughts correctly, difficulty thinking, lack of concentration, muscle soreness, aches all over body, tired easily, shortness of breath, fever, chills, and nausea. 36 hours after receiving vaccine, I still feel uneasy on my feet, light headedness, muscle soreness, stiff neck, nose bleeds, headache, nausea and extreme fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,OTH,NONE,NO,NO,,MACROBID,"['Balance disorder', 'Chills', 'Disturbance in attention', 'Dyspnoea', 'Epistaxis', 'Fatigue', 'Headache', 'Mental impairment', 'Muscle fatigue', 'Musculoskeletal stiffness', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia']",1,MODERNA,SYR 1000426,MA,44.0,F,"enlargement of lymph nodes under left axilla; no treatment to date, lumps are still there after 3 weeks",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/16/2021,2.0,PVT,none,none,none,,none,['Lymphadenopathy'],1,PFIZER\BIONTECH,IM 1000429,NY,19.0,F,Flu like symptoms. Arm pain. Redness at injection site that has not stopped spreading since receiving vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/03/2021,1.0,PVT,,,,,"Gluten,soy","['Influenza like illness', 'Injection site erythema', 'Pain in extremity']",2,MODERNA,SYR 1000488,MS,,F,"white cell count was marginally raised; CRP antigen was raised; Her hands are worse and she can't grip; hands are swollen; neurological thing; tenosynovitis; didn't sleep last night; She is becoming weaker and weaker; sweating and chills and some headaches; bodyache/pain; headache; severe chills; fever; This is a spontaneous report from a contactable physician. A 79-years-old female patient (Reporter's wife) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL8982, expiry date: unknown), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first vaccine on 14Jan2021 and at the same night experienced severe chills, fever, headache, and bodyache. Headache and bodyache has progressively gotten worse and patient was given tylenol and motrin which was starting to get less effective. It has been 6 days since the patient had these events, and reporter would like information specific to headaches and bodyaches lasting this long and how they were managed. It was further reported that the patient is too feeble and weak to talk right now. She is becoming weaker and weaker. She had the vaccine on 14Jan2021. That night she had sweating and chills and some headaches. The next day she had headache and pain all over her body. It got worse. It was a serious headache and serious pain. They talked to people who said it was a normal reaction. On the fourth day she got worse. She is getting weaker. He(reporter) wanted to make sure she did not have active COVID. They went to doctor's office and did COVID test, it was negative. Came back and she still had persistent headache. He took her back to the doctor on Sunday. Her CRP antigen was raised, liver function was normal. temp was normal. PO2 was between 96 and 99 which is normal. Her Creatinine was normal 1.2 or something. Her white cell count was marginally raised. Did PCR COVID test and it was normal. That night she slept well. Increased pain medication, Tylenol and nonsteroidal anti-inflammatory over the counter. That relieves the pain for only an hour or two and it comes back again. He clarified that his wife is taking Tylenol 1000mg and the over the counter nonsteroidal anti-inflammatory is Motrin 400mg every six hours. Today when she got up she said she was no better. She can't get out of the chair. It looks like a neurological thing. Her muscle power has reduced. The pain is severe. Her hands are worse and she can't grip. She has tenosynovitis in both hands so it is difficulty to assess. She had injections four or five weeks ago and it got better, but now she can't make a fist and her hands are swollen. Now the pain is intolerable. She is getting weaker and weaker. She is very lively. She may be seventy some years old, but you wouldn't know it. She didn't sleep last night. He is helping her get up and go to the bathroom. She is hurting and suffering. They were asking if there are any patients or people who had this reaction six of seven days after the vaccine. He is taking her to a neurologist today. Another doctor is coming to see her at their house. The outcome of the events bodyache/pain and headache was not recovered, while for other events was unknown. Therapeutic measures were taken as a result of bodyache/pain, headache.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events pain and headache cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,UNK,,,,,,"['Aphasia', 'Asthenia', 'Blood creatinine normal', 'C-reactive protein increased', 'Chills', 'Emotional distress', 'Grip strength decreased', 'Headache', 'Hyperhidrosis', 'Insomnia', 'Intellectual disability', 'Liver function test normal', 'Mobility decreased', 'PO2 normal', 'Pain', 'Peripheral swelling', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tenosynovitis', 'White blood cell count increased']",1,PFIZER\BIONTECH, 1000489,,,M,"I may have a blood clot in my leg.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the vaccine on 20Jan2021 and is going to visit his doctor because they think that he may have a blood clot on his leg on an unspecified date. He wanted to know if it was okay if they give him a shot of something like contrast to see the ultrasound. The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,,,UNK,,,,,,['Thrombosis'],1,PFIZER\BIONTECH, 1000499,CA,55.0,M,"angio edema of lips and periorbital area; Nasal and sinus congestion; rash on chest and face; wheezing; This is a spontaneous report from a contactable physician. A 55-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), intramuscular in left arm on 17Jan2021 at a single dose for COVID-19 immunization. Medical history included mixed hyperlipidemia. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on Jan2021 via intramuscular. On 17Jan2021, the patient experienced nasal and sinus congestion, rash on chest and face, angioedema of lips and periorbital area and wheezing. The outcome of the events was not recovered. The patient received an OTC antihistamine and monitored the condition. Information on the batch/lot number has been requested.; Sender's Comments: Based on a chronological association and known product safety profile, a causal relationship between event angioedema and BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/17/2021,01/17/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Mixed hyperlipidaemia,,,"['Angioedema', 'Nasal congestion', 'Rash', 'Sinus congestion', 'Wheezing']",2,PFIZER\BIONTECH,OT 1000512,,49.0,F,"Caller got the first dose of the pfizer covid 19 vaccine on 26Dec2020 and tested positive for covid on 30Dec2020.; Caller got the first dose of the pfizer covid 19 vaccine on 26Dec2020 and tested positive for covid on 30Dec2020.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL5738)on 26Dec2020 at single dose into right arm for COVID-19 immunization. Medical history was none. Concomitant medication included gummy bear vitamins, no further details provided. Patient did her first COVID test on 16Dec2020, prior to getting the vaccination, and was negative. Patient got the first dose of the vaccine on 26Dec2020 and on 30Dec2020 tested positive (via COVID-19 PCR test) for Covid . She was tested negative on 03Jan2021 and 04Jan2021 (both via COVID-19 PCR tests). She clarified that she went to a nursing home and was tested every 14 days when she went to see her mom and all times prior to getting the vaccine doses she was negative. She said her first dose of the vaccine was on 26Dec2020, then four days after that it was time to go get tested to go see her mom and the test was positive within no time it lights up. She said as a medical worker (she was a patient registration clerk at the emergency room- ER) she can wait 5 days after that for it to come up after being positive and after that if it was showing up negative she had to wait 24 hours to confirm negative test and repeated the test within 24 hours, which was negative too. Patient stated that other than having positive tests for COVID she has had no symptoms. Outcome of the event was unknown. Patient wanted to know if this was a herd immunity vaccine and if the vaccine had covid in it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021077994 same patient, different dose",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,12/30/2020,4.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000519,,,U,"A patient who has received the first dose, and then tests positive for COVID-19; A patient who has received the first dose, and then tests positive for COVID-19; This is a spontaneous report from a contactable pharmacist reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The pharmacist asked if there any information available for scheduling the second vaccine dose of the series in a patient who has received the first dose, and then tests positive for COVID-19 after already receiving the first dose. The outcome of the events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 test positive and suspected LOE due to temporal relationship. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000527,MN,30.0,F,"I was so faint/nearly passed out; so hot; very chilled for about 15 or 20 minutes; feeling sort ""off""; weak; fatigued/very drained/exhausted; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176), via an unspecified route of administration on 19Jan2021 at 08:15 AM at single dose in right arm for COVID-19 immunisation. Patient age at time of vaccination was years 30 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no known allergies. The patient had no relevant medical history and received no concomitant medications. The patient reported the following: 'About 5 minutes after receiving the vaccine I was so faint I nearly passed out and was so hot I was given an ice pack to try and cool me down. It took about 45 minutes for me to be able walk across one room. I then was very chilled for about 15 or 20 minutes, and very drained. The rest of the day I was back and forth between feeling sort ""off"" and feeling like I was weak, exhausted, and fatigued'. Adverse events onset date was reported as 19Jan2021 at 08:15 AM. No treatment was received for the events other than ice pack for feeling hot. The patient was recovering from the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Feeling cold', 'Feeling hot']",1,PFIZER\BIONTECH, 1000532,CA,38.0,F,"Bad cough; Trouble breathing; Tingling around mouth; Numbness in jaw and neck; Shaking; Red face and chest; Slight itching; This is a spontaneous report from a contactable healthcare professional (the patient). A 38-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular in the left arm on 18Jan2021 at 10:30 (at the age of 38-years-old) as a single dose for Covid-19 immunization. Medical history was not reported. The patient was allergic to penicillin. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1685) on 28Dec2020 in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ALERTEC), both for unknown indication from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Jan2021 at 11:00, the patient experienced bad cough, trouble breathing, tingling around mouth, numbness in jaw and neck, shaking, red face and chest, and slight itching. Treatment was given when seen by paramedics with an emergency room visit which included a second dose of allergy medication. The clinical outcome of the events bad cough, trouble breathing, tingling around mouth, numbness in jaw and neck, shaking, red face and chest, and slight itching was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The reported events were likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), considering the plausible temporal relationship and clinical course of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/18/2021,0.0,UNK,LEVOTHYROXINE; ALERTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Cough', 'Dyspnoea', 'Erythema', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia oral', 'Pruritus', 'Tremor']",2,PFIZER\BIONTECH,OT 1000543,,,M,"tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer(patient). A male patient of an unspecified age first dose received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization . The patient medical history and concomitant medications were not reported. The patient experienced tested positive for COVID on 12Jan2021 with outcome of unknown. Patient was scheduled for second dose on 27Jan2021, while doctors can't agree on whether he should et that second dose or not. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/12/2021,6.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000559,,,U,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable Physician. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient tested positive for covid-19 infection on 11Jan2021 with outcome of unknown. The reported wanted to know how long the patient should wait before receiving the second dose. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/11/2021,2.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000562,AZ,47.0,F,"She got tested with the COVID saliva test on 09Jan2021 and tested positive; She got tested with the COVID saliva test on 09Jan2021 and tested positive; headache; not feeling well; fell super run down; This is a spontaneous report from a contactable consumer. A 47-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899) via an unspecified route of administration at single dose arm left on 06Jan2021 16:45 for covid-19 immunisation. Medical history included allergy induced asthma, neoplasm malignant since 2011 (reported as 10 years ago), ongoing white blood cell count decreased. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) for allergy induced asthma, cetirizine hydrochloride (ZYRTEC) for allergy. No other vaccine was received in four weeks. Patient had headache on 09Jan2021, not feeling well on 09Jan2021, fell super run down on 09Jan2021. The patient got tested with the covid saliva test on 09Jan2021 and was positive. Patient just wanted to know if she can go forward to 2nd dose. The outcome of headache was not recovered, of fell super run down was recovering, of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/09/2021,3.0,UNK,SYMBICORT; ZYRTEC [CETIRIZINE HYDROCHLORIDE],White blood cell count low,Medical History/Concurrent Conditions: Allergic asthma; Allergy; Cancer (10 year ago),,,"['Fatigue', 'Headache', 'Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000565,,,M,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a non-contactable Consumer (patient). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive to covid-19 in Jan2021 (last week) with outcome of unknown. The patient wanted to know when he should receive the second dose. No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/01/2021,4.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000572,,,F,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; exposed to Covid positive patient; This is a spontaneous report from a contactable nurse (patient). A 44-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was exposed to Covid positive patient on 15Jan2021. She tested positive for Covid 19 the following Monday 18Jan2021. The patient wanted to know if now that she was positive, she should still proceed with the second dose in February. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. Occupational exposure to SARS-CoV-2 is most likely related to an intercurrent condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/15/2021,4.0,UNK,,,,,,"['COVID-19', 'Occupational exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000592,,54.0,F,"patient tested positive for covid virus; patient tested positive for covid virus; This is a spontaneous report from a contactable consumer (patient), received via a Pfizer-sponsored program. A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 07Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that on 13Jan2021, the patient tested positive for covid virus. The patient would like to know about getting the second dose of vaccine. Outcome of the event was unknown. Information about Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/13/2021,6.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000616,MA,,F,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable female consumer (patient) from a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested covid positive on 07Jan2021, after she got her first dose of pfizer covid vaccine. The outcome of the event was unknown. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/07/2021,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000620,CA,49.0,M,"Redness and itching of head and forehead; Redness and itching of head and forehead; hypertension; This is a spontaneous report from a contactable Pharmacist. A 49-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL3302, expiry date: May2021, NDC number: 59267100001) intramuscularly in deltoid right on 20Jan2021 at 0.3 ml single for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporting pharmacist works with a group of five pharmacists. Colleague administered Covid-19 Vaccine to the patient an hour ago. Patient presented with side effects. Pharmacist clarified adverse event as itching of the head and forehead. Forehead looked pretty red and as if there were pimples, but patient was scratching hard. Occurred 15-20 minutes after vaccination (20Jan2021). Pharmacist checked patient for other symptoms of breathing and swelling. Patient stated he was ok in that aspect. Pharmacist gave patient two 25 mg tablets of Benadryl. Pharmacist states patient is healthy and just has hypertension (20Jan2021). Patient is still at the clinic and is going to check back in with caller about how he is doing. Doesn't have exact time of vaccination. Seriousness: At least medically significant. Patient was able to go back to the kitchen and do his job. Pharmacist asked how would he know that is not an allergic reaction and if the second dose should be given. Sticker states NDC is 5926710001, but pharmacist believes NDC is 59267100001. Vaccination Facility Type was Nursing home. Additional Vaccines Administered On Same Date Of Pfizer Suspect was No. Pharmacist makes sure other vaccinations are separated by two weeks. All events required Physician Office Visit. Prior Vaccinations Within 4 Weeks was Unknown. AES Follow Prior Vaccinations was Unknown. Relevant Tests was None. Benadryl allergy tablet, 25 mg NDC: 50580- 226-51 Lot: SFF084 Exp: Feb2022. Pharmacist asked if second dose should be submitted. The outcome of the events was unknown.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events pruritus, erythema and hypertension cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/20/2021,0.0,SEN,,,,,,"['Acne', 'Erythema', 'Pruritus']",1,PFIZER\BIONTECH,OT 1000624,,,M,"Pneumonia; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A male patient of unspecified age (Age: 63; Unit: Unknown) received the first dose and second dose of BNT162B2, via unspecified routes of administration on unspecified dates at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. After receiving both vaccines, patient still got pneumonia and he had seen many elderly died from pneumonia even after receiving the vaccine. Outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Pneumonia'],2,PFIZER\BIONTECH, 1000626,WI,57.0,F,"she may have already had COVID 19 with the symptoms she has now; she may have already had COVID 19 with the symptoms she has now; was feeling bad; she lost her taste and her smell; she lost her taste and her smell; tired; sleeping all the time; she is sick; She still hasn't eaten a whole meal since Friday; not able to eat; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL0142, exp date not reported), intramuscular (by injection once left arm, below shoulder blade in muscle) on 13Jan2021 for COVID-19 immunization (because of job). Medical history included two stroked from 1998 and 2005. Concomitant medication included oral donepezil started taking 3 months ago (Oct2020) for something having to do with muscles because of stroke. She takes a blood thinner, as she had 2 strokes; and takes muscle relaxers too. By 15Jan2021 (Friday morning) the patient was feeling bad, she couldn't go to work, she lost her taste and her smell, part of smell. Part of taste was back at the time of reporting, but she was tired and sleeping all the time (onset date reported as 15Jan2021). She saw her neurologist because she had 2 strokes, they referred her to Pfizer, as they said she may have already had COVID 19 with the symptoms she has, but as far as she knows, she didn't have it, she took a test with the center a month before giving the vaccine, she took the vaccine because of her job, because of the kind of job she has, and they wanted her to let Pfizer know she was sick. She doesn't know if she wanted to get the other dose, as she was not feeling well at all. She was laying down sleeping every day. Her doctor said to tell Pfizer what was going on. She still doesn't feel good the day of reporting. She still hasn't eaten a whole meal since 15Jan2021. She thinks she was probably getting better, but was getting better slowly, she has no taste, she was not able to eat, no smell at all, which was really not a good thing. She can't tell the outcome of no smell she thinks. She can't smell nothing at all. She can't smell what she was cooking. It was the same as taste, she thought that is probably why she can't eat, she can't taste what she was eating. Taste was improved, but not well enough for her, it is hard to explain, you know how you enjoy food, like how it tastes, and if you can't taste, you can't eat. She sleeps all day, she was up now, but is probably going to go to sleep, she feels tired and needs to lay down. She told her doctor she will call and see what Pfizer says, they will go from there. She doesn't know if she will have to go see if she has COVID 19, or what was going on. No further investigation assessment was performed. The patient took a test a month before (results unknown). No taste was recovering (ongoing at the time of reporting) while outcome of other events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/15/2021,2.0,UNK,DONEPEZIL,,Medical History/Concurrent Conditions: Stroke,,,"['Ageusia', 'Anosmia', 'Decreased appetite', 'Fatigue', 'Hypersomnia', 'Impaired work ability', 'Malaise', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1000627,FL,,F,"tested positive for Covid-19 after getting the vaccine; tested positive for Covid-19 after getting the vaccine; This is a spontaneous report from a contactable consumer via the Pfizer Sponsored Program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date was not reported), via an unspecified route of administration on 11Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid-19 after getting the vaccine on 14Jan2021. The reporter and his wife both took a rapid test on 08Jan2021 and it was negative. On 11Jan2021, they both got their first dose of the vaccine. The patient had a swab test done on 14Jan2021; she is asymptomatic, but her test was also positive. They wanted to know if it's ok to get the 2nd dose of vaccine. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045686 Same reporter, drug, and event with different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/14/2021,3.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test negative', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000628,NY,31.0,F,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from contactable consumer (patient) from a Pfizer-sponsored program Pfizer First Connect. A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/lot number: EK9231), via an unspecified route of administration in the left arm on 03Jan2021 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient tested positive for covid on 10Jan2021 with outcome of not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/10/2021,7.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000631,TN,,U,"came down with COVID in a week; came down with COVID in a week; This is a spontaneous report from a contactable physician. This physician reported similar events for 4 patients. This is third of four reports. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 immunisation. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient came down with COVID in a week of vaccination. The outcome of the event came down with COVID in a week was unknown. The reporting physician stated that he doesn't think that them getting the vaccine and having COVID is related, he thinks it is a coincidence. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021064977 as same reporter/drug/AE/different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000632,NC,30.0,F,"Tested positive for Covid a week later; Tested positive for Covid a week later; This is a spontaneous report from a contactable other hcp (patient). A 30-year-old non-pregnant female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 04Jan2021 08:45, and 1st dose on an unspecified date via an unspecified route of administration; both at single doses for COVID-19 immunization. There were no medical history and concomitant medications. The patient has no known allergies. On 12Jan2021, the patient tested positive for COVID a week later from 2nd dose. Outcome of the events was reported as recovering. No treatment was given for the events. The patient underwent lab tests and procedures which included Nasal Swab: positive on 13Jan2021. The patient was not diagnosed with COVID prior vaccination. Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported ""tested positive for Covid a week later"".",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,01/12/2021,,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000635,FL,,U,"Diagnosed with COVID after first vaccine; Diagnosed with COVID after first vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was diagnosed with COVID after first vaccine and wanted to know if the patient could take the second dose afterwards. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000638,WV,,M,"got the first dose of COVID vaccine and afterwards he tested positive for COVID; got the first dose of COVID vaccine and afterwards he tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored Program, Pfizer First Connect, received from a contactable nurse. A male patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient received first dose of COVID vaccine and afterwards he tested positive for COVID. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000640,TN,,U,"all got the first dose, and they all came down with COVID in a week; all got the first dose, and they all came down with COVID in a week; This is Spontaneous report from a contactable Physician. This physician reported similar events for four patients. This is the fourth of four reports. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 immunisation. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient came down with COVID in a week of vaccination. The outcome of the event came down with COVID in a week was unknown. The reporting physician stated that he doesn't think that them getting the vaccine and having COVID is related, he thinks it is a coincidence. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021064977 same reporter/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000644,OK,45.0,F,"Stress on body; Little over weight- usually about 150 sometimes 162 around this time she was 162; Stage 3 kidney failure; High/Increased blood pressure; Outbreak of genital herpes; Hip pain bilateral; Extreme fatigue; on and off headaches/Intermittent headache; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiration date not provided), via an unspecified route of administration (anatomical location: arm left) on 04Jan2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history ongoing included sickle cell trait (diagnosed as a child, sickly as a child, found out in 2016. It was reported that patient has the sickle cell that mimics the disease), ongoing high blood pressure, and ongoing genital herpes, and pre-diabetes, all diagnosed prior to vaccination, and 'blood pressure'. Concomitant medication included chlorthalidone from 2018 and ongoing for 'blood pressure'. It was reported that patient got her first dose of Covid vaccine on 04Jan2021. Patient stated that she has been experiencing some effects, started maybe 2 days after, she began experiencing fatigue (06Jan2021). Patient also stated that she has genital herpes diagnosed before the vaccine, and stated that she usually doesn't have an outbreak unless there is extreme stress on body. On 08Jan2021, patient clarified she experienced a genital herpes outbreak and thought that it may associated. Patient stated that she treated it with valaciclovir (VALTREX) and some cream and it went away. States that she had another outbreak after, treated it again, and it went away and now she is struggling with another outbreak of genital herpes. Patient also reported that she has on and off headaches (also reported as intermittent headaches) on 04Jan2021, states this could be due to her high/increased blood pressure which she first experienced on 14Jan2021 (as reported). Patient mentioned that her blood pressure has been higher than it ever has been after the vaccine. Patient also stated that she noticed that after the vaccine it was out of control, that she got a blood pressure cuff and it was 149/103, she contacted her nephrologist, stated she is treating it with her usual diuretic and the doctor just prescribed her amlodipine (NORVASC). Patient further stated that she is still struggling to get the diastolic blood pressure in the 90s, stated this is abnormal for her. Also is experiencing severe hip pain bilateral on 08Jan2021 after the vaccine. Patient further reported that she was a little over weight - usually about 150 sometimes 162 around this time she was 162. Patient clarified that her current weight is 159.2 and stated that she was diagnosed with sickle cell trait and stated that she has the kind that mimics the disease and will have a lot of side effects of sickle cell disease. Patient further added that she also has stage 3 kidney failure on 18Jan2021 due to either her high blood pressure or sickle cell trait and is also pre-diabetic. Patient also thought that the outbreak was associated with stress on body. Patient wanted to know if she refuses the second vaccine, if the first vaccine will do anything. Outcome of the events 'Stage 3 kidney failure', 'High/Increased blood pressure', 'Outbreak of genital herpes', and 'on and off headaches/Intermittent headache' was not recovered, outcome of the event 'extreme fatigue' was recovered on 06Jan2021, outcome of the event 'hip pain bilateral' was recovering, outcome of the remaining events was unknown.; Sender's Comments: The reported stage 3 kidney failure was due to either the pre-existing high blood pressure or sickle cell trait or prediabetic condition, and was unrelated to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,UNK,CHLORTHALIDONE,Blood pressure high; Genital herpes; Sickle cell trait,Medical History/Concurrent Conditions: Blood pressure abnormal; Pre-diabetes,,,"['Arthralgia', 'Blood pressure diastolic abnormal', 'Chronic kidney disease', 'Condition aggravated', 'Fatigue', 'Genital herpes', 'Headache', 'Hypertension', 'Overweight', 'Renal failure', 'Stress']",1,PFIZER\BIONTECH, 1000646,AL,35.0,M,"Oxygen saturation low/ checked his oxygen level and it was 78 and then after a few minutes it was 86 and 88; Fever of 102 F for 4 days; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration (Unknown if given intramuscularly) on 15Jan2021 09:30 at a single dose on left arm below shoulder for COVID-19 immunization. Medical history included none. There were no concomitant medications. The patient experienced fever of 102 for 4 days on 16Jan2021 14:00 and oxygen saturation low on 20Jan2021 12:00 (reported as ""12:00 - 12:30""). He received first dose 15Jan2021. He has not had a cough, but had 102 degree Fahrenheit fever for 4 days, so he had to stay home from work. He had to get a COVID test and it was negative today (unspecified date). While he was there, they checked his oxygen level and it was 78 and then after a few minutes it was 86 and 88. There was no prescriber. He received it at a healthcare facility. He is supposed to go back to get second dose on 05Feb2021. It is unknown if it was given intramuscularly. The outcome of the events was not recovered. NO ER or physician's office required. He is to follow up with his general practitioner, but he has not gone yet. No prior vaccinations (within 4 weeks) and no adverse event following prior vaccinations. No additional vaccines administered on same date of the Pfizer Suspect. Vaccination facility type was Hospital. Family medical history includes, Father is Diabetic and mother has colon cancer.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/16/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No,,,"['Oxygen saturation decreased', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 1000650,,47.0,F,"Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with severe ocular pressure; palpitations; dizziness; Tingling and numbness to hands and feet; Tingling and numbness to hands and feet; Vein engorgement and swelling of left leg; Vein engorgement and swelling of left leg; right abdominal and flank pain; right abdominal and flank pain; crushing headache with severe ocular pressure; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 47-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: El3249), via an unspecified route of administration in the left arm on 19Jan2021 at 15:30 as a single dose, for COVID-19 vaccination. The vaccine was administered in a Nursing Home/Senior Living Facility. Medical history included asthma and known allergies (details not provided). Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 at 15:30, the patient experienced Profound weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure. The events resulted in an emergency room visit and physician office visit. No treatment was given for the events. The clinical outcome of weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,SEN,ALBUTEROL [SALBUTAMOL],,Medical History/Concurrent Conditions: Allergy (known_allergies: Yes); Asthma,,,"['Abdominal pain', 'Asthenia', 'Bone pain', 'Dizziness', 'Flank pain', 'Headache', 'Hypoaesthesia', 'Myalgia', 'Ocular discomfort', 'Palpitations', 'Paraesthesia', 'Peripheral swelling', 'Peripheral venous disease']",1,PFIZER\BIONTECH, 1000651,WI,51.0,F,"chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm is killing her; pain was in her body/whole body was killing her; not able to walk; whole body joint pain; feeling cold and warm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date not reported), intramuscular on the left arm on 19Jan2021 10:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiry date not reported), intramuscular on the left arm on 29Dec2020 10:15 for COVID-19 immunization and experienced arm was sore and hurting. The patient reported that she just got the second dose of the vaccine yesterday (19Jan2021). She had a really bad side effects. With the first dose only her arm was sore and hurting, states it was nothing, she did not have side effects. With the second dose her left arm is killing her on 19Jan2021. She clarifies the side effects that she is experiencing are whole body joint pain and muscle pain on 19Jan2021, chills on an unspecified date, nausea on 20Jan2021, headache on an unspecified date, and she is very, very tired on 19Jan2021. She received the second dose of the vaccine around 10:15 am yesterday and she went to work and she was ok. About 12 hours later on 19Jan2021 she started feeling bad, by 10-10:30pm her whole body was killing her and she was not able to walk. Around 11:15pm she had to talk to her supervisor since she was not able to work. She was experiencing the whole body pain and muscle pain. She did not have nausea or dizziness last night. She could not sleep last night, she was not comfortable in bed since she was in pain, her pain was in her body. She started feeling dizzy and nauseous this morning (20Jan2021) when she was getting out bed. States she could not even drive, she wish she had someone that could have picked her up from work since it was horrible. She reported all night she was feeling cold and warm, yesterday she felt warm and she thought she had a fever and when she checked her temperature she did not have a fever. Her temperature this morning was 97.5. Right now she feels freezing, the chills. The patient underwent lab tests and procedures which included body temperature: 97.5 on 20Jan2021. The patient did not recover from her left arm is killing her, whole body joint pain, feeling cold and warm, muscle pain, nausea, very tired, and dizziness while the outcome of the rest of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,PVT,,,,,,"['Arthralgia', 'Body temperature decreased', 'Chills', 'Discomfort', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Feeling of body temperature change', 'Gait inability', 'Headache', 'Impaired driving ability', 'Impaired work ability', 'Insomnia', 'Laboratory test', 'Loss of personal independence in daily activities', 'Myalgia', 'Nausea', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,OT 1000652,,49.0,F,"Caller had the second shot 16Jan2021 and was tested today 20Jan2021 and now she is back positive.; Caller had the second shot 16Jan2021 and was tested today 20Jan2021 and now she is back positive.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on 26Dec2020 (first dose; Batch/lot number: EL5738) at single dose into right arm and on 16Jan2021 (second dose LOT EL3248) at single dose into left arm. Medical history was none. Concomitant medication included gummy bear vitamins, no further details provided. Patient did her first COVID test on 16Dec2020, prior to getting the vaccination, and was negative. Patient got the first dose of the vaccine on 26Dec2020 and on 30Dec2020 tested positive (via COVID-19 PCR test) for Covid. She was tested negative on 03Jan2021 and 04Jan2021 (both COVID-19 PCR tests). Patient had the second shot on 16Jan2021 and COVID-19 PCR test on 20Jan2021 was back positive. Patient clarified she got the injection twice, and each time she has gotten it and gotten tested after, each test was showing positive. She clarified that she went to a nursing home and was tested every 14 days when she went to see her mom and all times prior to getting the vaccine doses she was negative. She said her first dose of the vaccine was on 26Dec2020, then four days after that it was time to go get tested to go see her mom and the test was positive within no time it lights up. She said as a medical worker (she was a patient registration clerk at the emergency room- ER) she can wait 5 days after that for it to come up after being positive and after that if it was showing up negative she had to wait 24 hours to confirm negative test and repeated the test within 24 hours, which was negative too. She got the second dose on 16Jan2021 and then she went to go get tested to go back to the nursing home and again it came back positive. Outcome of the event was unknown. Patient wanted to know if this was a herd immunity vaccine and if the vaccine had covid in it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021051224 same patient, different dose",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,01/20/2021,4.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 1000653,MN,82.0,M,"Dramatic unexplained drop in INR from 2.9 on January 11, 2021 to 1.3 on January 25, 2021; This is a spontaneous report from a contactable consumer (patient). This 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231) via an unspecified route of administration in the right arm on 21Jan2021 at 09:45 at single dose for COVID-19 immunisation. Vaccination facility type: urgent care center. The patient did not receive other vaccines in four weeks. Relevant medical history included recent stroke, cardiac failure congestive, chronic obstructive pulmonary disease, chronic renal failure, diabetes, high cholesterol, SP aortic valve replacement, atherosclerotic cardiovascular disease and COVID-19 (the patient had COVID-19 prior to vaccination). Concomitant medications included hydralazine, carvedilol, warfarin and isosorbide. On 25Jan2021 at 09:00, the patient experienced dramatic unexplained drop in INR from 2.9 on 11Jan2021 to 1.3 on 25Jan2021. The event resulted in life-threatening illness (immediate risk of death from the event). Corrective treatment taken as a result of the event included subcutaneous enoxaparin sodium (LOVENOX) twice daily. The patient was not tested for COVID-19 after the vaccination. At the time of the report, the outcome of the event was unknown.",Not Reported,,Yes,Not Reported,,Not Reported,U,01/21/2021,01/25/2021,4.0,OTH,HYDRALAZINE; CARVEDILOL; WARFARIN; ISOSORBIDE,,Medical History/Concurrent Conditions: Aortic valve replacement; Atherosclerotic cardiovascular disease; Chronic renal failure; Congestive heart failure; COPD; COVID-19 (The patient had COVID-19 prior to vaccination); Diabetes; High cholesterol; Stroke,,,"['Apparent life threatening event', 'International normalised ratio decreased']",1,PFIZER\BIONTECH, 1000654,TN,58.0,F,"white mucous stools with blood; abdominal pain; tenesmus; white mucous stools with blood; fatigue; chills; headache; temp 99.5; This is a spontaneous report from a contactable nurse. This 58-year-old female Nurse (Patient) reported that A 36-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19 pfizer, Lot#: EL3246), via an unspecified route of administration on 11Jan2021 01:00 PM on Right arm at single dose for COVID-19 immunisation. She is not pregnant. Medical history was none. Known allergies: NKA. Facility type vaccine was other. No other vaccine in four weeks. Concomitant medications included thyroid (ARMOUR THYROID), estrogens conjugated/medroxyprogesterone acetate (PREMPRO), Regular vitamin. 4:00 am on 20Jan2021 woke with abdominal pain, tenesmus, white mucous stools with blood, fatigue, chills, headache, Temp 99.5 called physician told it sounds like reaction. Took Tylenol 500 mg for symptoms. 21Jan2021 feel better but still mucous blood stools dr wants to see me monday 25Jan2021 if still having blood. AE resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered with lasting effects. Treatment received. No COVID prior vaccination. No COVID tested post vaccination.; Sender's Comments: Based on the information currently available and in absence of strong confounding factors, a possible contributory role of the suspect BNT162B2 in triggering the onset of blood stool cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/20/2021,9.0,UNK,ARMOUR THYROID; PREMPRO,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Abdominal pain', 'Body temperature increased', 'Chills', 'Faeces discoloured', 'Fatigue', 'Haematochezia', 'Headache', 'Mucous stools', 'Rectal tenesmus']",1,PFIZER\BIONTECH, 1000655,MN,26.0,F,"tired; head feels fuzzy; throat and neck pain; throat and neck pain; hurts to swallow; Low grade fever/low grade temp of 99.4; Headache; body aches; This is a spontaneous report from a contactable Nurse (patient). A 26-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left deltoid on 20Jan2021 11:00 at 0.3 mL, single for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient received her first dose yesterday at 11:00am. She was talking to someone and all of a sudden she got throat to neck pain that was intense that lasted two minutes on 21Jan2021. It has been about 10-15minutes since and if she hold her neck straight she is fine, but if she looks up it hurts. She can breathe fine. It hurts to swallow all of a sudden on 21Jan2021. Asking if it is normal to experience this. She had a low grade fever/low grade temp of 99.4, body aches, and a headache that started today 21Jan2021. She received Tylenol as treatment. States she is a nurse and she is tired. Her head feels fuzzy, she has not taken her temperature recently and it still hurts to swallow. The events did not require a visit to emergency room or physician office. Relatedness of drug to events from reporter for throat and neck pain, hurts to swallow, low grade fever, headache, body aches was reported as related. Reporter seriousness for throat and neck pain and hurts to swallow was medically significant. Event outcome of throat and neck pain was recovered, of hurts to swallow was not recovered, of others was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: The reported events were likely causally related to the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. However, it is worth noting that the reporter/user of the vaccine was nurse, and her tiredness from job could have confounded with the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/21/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Fatigue', 'Feeling abnormal', 'Headache', 'Neck pain', 'Odynophagia', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,OT 1000658,TN,68.0,M,"Stroke; leukemia; This is a spontaneous report from a contactable consumer. This consumer reported for a 68-year-old male (consumer's husband) received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EL0140, Expiry Date: Mar2021), via an unspecified route of administration on 31Dec2020 13:30 at single dose on right upper shoulder for COVID-19 prophylaxis. Medical history included smoker for 50 years, and blockage in his carotid artery. His grandma died of a stroke and his folks, his dad died of lung cancer and his mom died of uterine cancer. Both his parents had high blood pressure. His dad had a heart attack and his mom had Parkinson's because her hands would shak. There were no concomitant medications. On the 08Jan2021 at about 8PM he had a massive stroke and they had to life flight him to hospital from 08Jan2021 to 19Jan2021. He did have a blockage in his carotid artery but they have been told. She says her husband just had his second vaccine with lot is EL1283 and exp is Apr2021 and all of this could be a coincidence but he told her to call so that was why she was calling. Also he was diagnosed with, it is 4 words and then leukemia and he had an appointment with doctor to get his blood drawn every 2 weeks. The neurosurgeon that did surgery on him on 09Jan2021 at 4 am said that his carotid artery in his neck was plugged and he went in and cleaned it out and put in a stent and he said that his carotid artery was plugged all the way to his temple and he tried to get that out and couldn't. He had his stroke at 8PM on the 08Jan2021. They had dinner at 5 pm and at 6pm they were sitting on the couch and all of sudden he started slurring his words and he said his mouth felt like someone give him Novocain and then he had his arm around her and all of sudden it felt like he was choking her so she grabbed his hand and his fingers started rolling up, started closing up tight so she started playing with his fingers and then he went out in the kitchen and then he hit the floor and she called # and the paramedics came up there. When they got there he could squeeze both hands and lift both feet by that time it was 7:30, they had just brought in a chair, by time they got done bringing in the chair they realized his left side was becoming paralyzed and so they had to go back and get the stretcher so they were there for about 30 minutes, maybe 15 minutes then they headed up the hill toward the hospital at about 8pm and they came in and gave anti-blood clotting medicine and took him for a scan with dye, they found he still had a blockage on his brain so at 2AM on the 9th they came in with a medical helicopter and flew him to (institution name withheld) in (place name withheld) and they did an MRI on and seen his carotid blockage there so he had emergency surgery at from # that morning of the 09Jan2021 at (institution name withheld) and he was in ICU from Saturday until a week ago at 3 oclock 13Jan2021 he was placed in a regular room and on the 19Jan2021 at 7:30PM he was moved (hospital name) in (place name withheld) for 14 days having 15 hours per day of therapy for a week and then he will go to (place name withheld) (rehab name withheld) and he could be there 2-3 weeks. Wednesday right before they moved him he needed a therapist in the back and one in the front and a 6 inch belt to help him stand up. He started out 08Jan2021 and was put in (institution name withheld) on the 09Jan2021 and then he was discharged to rehab on the 19Jan2021 7:30 pm She has been told it may take up to year for recovery as much as he can. The week of his stroke they were adding on to his home and he was doing the electrical upstairs so it is not like he just sat around and ate bon bons, he was very active. The outcome of the events was unknown.",Not Reported,,Not Reported,Yes,11.0,Not Reported,U,12/31/2020,01/01/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Carotid artery disease NOS; Smoker (for 50 years),,,"['Arteriogram carotid abnormal', 'Carotid artery stent insertion', 'Cerebrovascular accident', 'Choking sensation', 'Dysarthria', 'Dyskinesia', 'Dysstasia', 'Hemiplegia', 'Hypoaesthesia oral', 'Intensive care', 'Leukaemia', 'Magnetic resonance imaging abnormal', 'Syncope']",1,PFIZER\BIONTECH, 1000659,CO,26.0,F,"Numbness and tingling in both feet and lower extremities; Numbness and tingling in both feet and lower extremities; This is a spontaneous report from a contactable Registered nurse reporting for herself. A 26-years-old female patient received the first dose BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EL3302, via an unspecified route of administration in right arm on 19Jan2021 at 17:30, at 26 years of age, at single dose for COVID-19 immunization as she was a front line worker. The vaccine was administered at the facility where the patient works. The patient had no relevant medical history and no concomitant medications. On 19Jan2021, about 20 minutes after receiving the vaccine dose (also reported at 18:00) she started having nonstop numbness and tingling in both feet and lower extremities, which has been going on for 46 hours straight. The events were assessed as medically significant, although a visit to emergency room or physician office was not required. The nurse reported that a doctor mentioned Guillain-Barre Syndrome which can lead to progressive muscle weakness and damaged nerves and she is severely concerned, although she has no health history. At the time of the report the reported events had not recovered yet. The reporter assessed the event related to BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (Method of assessment: Global Introspection).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,SEN,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No/She has no health history",,,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH, 1000660,MI,20.0,F,"Tested positive for having the Covid Virus; Tested positive for having the Covid Virus; This is a spontaneous report from a Pfizer-sponsored Program. A contactable consumer reported that a 20-year-old female patient (reporter's daughter) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration in Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received the first dose on 04Jan2021 or 05Jan2021 and was tested positive for having the COVID-19 virus. They want to know when and if she can get the second dose. She returned to school and she took the spit swab that the university was requiring for all students. She took it on Saturday or Sunday (unspecified dates in Jan2021) and she got the result yesterday morning and it was positive. It was reported that she was currently isolated, she went home, she was fine and everything. It was also stated that she is asymptomatic and she really has no signs. Outcome of the events was unknown. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000661,FL,68.0,M,"Cardiac Arrest; Ventricular Fibrillation; This is a spontaneous report from a contactable physician reporting for a patient. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN), hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) in two weeks. It was unknown if the patient received Other vaccine in four weeks, if patient had Covid prior vaccination, if Covid was tested post vaccination. Patient went for Running after returning home suffered Cardiac Arrest, Ventricular Fibrillation on 28Jan2021, CPR (Cardiopulmonary resuscitation) by Wife, Intubated by EMS (Emergency Medical Service) brought to the Hospital. The adverse events resulted in visiting Emergency room/department or urgent care and Life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of cardiac arrest and ventricular fibrillation which included CPR and Intubated. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cardiac arrest and ventricular fibrillation cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,UNK,ASPIRIN [ACETYLSALICYLIC ACID]; LISINOPRIL HCTZ,,,,,"['Cardiac arrest', 'Endotracheal intubation', 'Resuscitation', 'Ventricular fibrillation']",UNK,PFIZER\BIONTECH, 1000663,FL,65.0,F,"Got tested and came positive after receiving first vaccine; Got tested and came positive after receiving first vaccine; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported similar events in two patients. This is the first of two reports. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not reported), intramuscular on 10Jan2021 at single dose for COVID-19 immunization. Medical history included asthma. Concomitant medication included vitamins nos. It was reported that both the patient and her husband received the Pfizer Vaccine on 10Jan2021; and they had reaction to it. They both both had bad arm swelling and pain. Her was worst she couldn't even lift or move her arm. At first, they just thought it was a reaction as they read reactions could be and then she started to get small cough but by Friday, her husband went and got tested and on Wednesday he was tested positive and this is after the vaccine and then he got the results and it said he was positive. So, Saturday, they both went and got tested, they did the rapid and they did what they call the PCR, and they both came positive for both of them and this was after they receive the first vaccine. So, she thought they need to know that they got sick and it was after the vaccine. The patient needed to ask a question as they were supposed to go for their second vaccine on 31Jan2021 and do they do it even though they got sick. They knew they were claiming that they can't get sick because of the vaccine but it's very ironic that they did get this. They had been following CBC guidelines, both her husband and the patient because they are older and they wear mask all the time and they did everything they needed to and they could not understand how they got this. The patient underwent lab tests and procedures which included Rapid and PCR: positive in Jan2021. Therapeutic measures were taken as a result of ""bad arm swelling and pain; worst she couldn't even lift or move her arm"" which included treatment with Tylenol. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092094 same reporter and drug, similar events in a different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/01/2021,,UNK,VITAMINS NOS,,Medical History/Concurrent Conditions: Asthma,,,"['COVID-19', 'Cough', 'Malaise', 'Mobility decreased', 'Pain in extremity', 'Peripheral swelling', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,OT 1000664,FL,,M,"Tested positive after receiving the vaccine; Tested positive after receiving the vaccine; bad arm swelling and pain; bad arm swelling and pain/leg pain; not feeling well having severe back pain; not feeling well; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events in two patients. This is the second of two reports. A 67-year-old male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included vitamins nos. It was reported that the patient as well as the reporter had bad arm swelling and pain. By Wednesday the patient was not feeling well he was having severe back pain and leg pain and what not. At first they just thought it was a reaction as they read reactions could be and then the reporter started to get small cough but by Friday the patient went and got tested and on Wednesday he was tested positive and this is after the vaccine and then he got the results and it said he was positive. So, Saturday they both went and got tested, they did the rapid and what they call the PCR, and they both came positive for both of them and this was after they receive the first vaccine. The patient underwent lab tests and procedures which included Rapid and PCR: positive on Jan2021. Therapeutic measures were taken as a result of bad arm swelling and pain, not feeling well having severe back pain and leg pain which included treatment with Tylenol. The outcome of the events was unknown. Information on Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092066 same reporter and drug, similar events in a different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,,,UNK,VITAMINS NOS,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Back pain', 'COVID-19', 'Cough', 'Malaise', 'Pain in extremity', 'Peripheral swelling', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000665,FL,97.0,M,"Death 2 days later; This is a spontaneous report from a contactable Other HCP. A 97-year-old male patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via intramuscular in the left arm on 18Jan2021 12:00 PM at single dose for covid-19 immunisation. Medical history included prostate cancer, macular degeneration, type 2 diabetes, atrial fibrillation. No known allergies. Concomitant medications included glipizide, warfarin and metformin in two weeks. The patient had no other vaccine in four weeks. The patient experienced death on 20Jan2021 at 09:00 PM. Death cause was undetermined. No autopsy was performed. No treatment was received for AE. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the event was fatal.; Sender's Comments: Event unknown cause of death is assessed as Related until sufficient information is available to confirm an unrelated cause of death or if there is sufficient information to allow an unrelated causality assessment. Case will be reassessed when follow-up information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death 2 days later",Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/20/2021,2.0,SEN,GLIPIZIDE; WARFARIN; METFORMIN,,Medical History/Concurrent Conditions: Atrial fibrillation; Macular degeneration; Prostate cancer; Type 2 diabetes mellitus,,,['Death'],1,PFIZER\BIONTECH,OT 1000666,,,U,"confirmed about a blood clot/check me for a blood clot, I didn't have one but it was kind of like a thrombosis kind of thing; Both of my legs, lower part of my legs were swollen that night when I went to bed and they got really red, almost purply red; Both of my legs, lower part of my legs were swollen that night when I went to bed and they got really red, almost purply red; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer stated that after the first vaccine and it might be coincidental, the patient was not sure because the patient didn't know what to expect. Both of the patient's legs, lower part of the patient's legs was swollen that night (unspecified date) when the patient went to bed and they got really red, almost purply red and the patient stayed that way for a couple of days. The patient went to see the doctor two days later and doctor confirmed about a blood clot, so they did check the patient for a blood clot; the patient didn't have one, but it was kind of like a thrombosis kind of thing. So, the doctor put the patient on antibiotics for that. The patient asked if it is related to the shot, the patient didn't know it happened the same day the patient got the shot; so, the patient didn't know about that. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Erythema', 'Peripheral swelling', 'Thrombosis']",1,PFIZER\BIONTECH, 1000670,AL,87.0,F,"she was hurting at her chest/ Chest pain; on her left arm hurt real bad that's what the clot on her left arm; on her left arm hurt real bad that's what the clot on her left arm; She passed away; heart attack; This is a spontaneous report from a contactable consumer. An 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus, for which she was taking a pill like an hour before she would take her meal. On Monday (Jan2021) the patient experienced was hurting at her chest/ chest pain, her left arm hurt real bad as she had a blockage in her left arm/clot on her left arm, and they wanted to put in a stent and after the surgery it went well and she all go home in two days. The patient was hospitalized in Jan2021 due to the events. She had a heart attack and that the chamber between the dividers had a hole in it and her heart tissue was too thin so much thin she couldn't repair it. The patient passed away on 26Jan2021. The patient was tested negative for COVID-19 on unknown date. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: She passed away",Yes,01/26/2021,Not Reported,Yes,,Not Reported,N,01/19/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Diabetes,,,"['Chest pain', 'Death', 'Myocardial infarction', 'Pain in extremity', 'SARS-CoV-2 test negative', 'Stent placement', 'Thrombosis']",1,PFIZER\BIONTECH, 1000671,IL,54.0,F,"re-dislocated right shoulder; This is a spontaneous report from two contactable physicians. A 54-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration on 09Jan2021 at a single dose for covid-19 immunization. Vaccination was done in a hospital. Vaccine was not administered at a military facility. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (at the age of 54-year-old) lot number: EK5730, intramuscularly at the left arm on 19Dec2020 at a single dose for COVID-19 immunization and experienced fractured and dislocated rt shoulder while doing exercise on 20Dec2020 0930 and torn labrum on 24Dec2020. The patient had no history of previous immunization. The patient is not deceased. Patient had no other prior vaccinations within four weeks. The patient experienced re-dislocated right shoulder on 11Jan2021 15:50 but did not require hospital admission. Therapeutic measure was taken as a result of the event which included wearing brace and surgery tentative. Outcome of the event was not recovered. It was reported that there was a reasonable possibility that the event is related to suspect product.; Sender's Comments: Based on the available information the event ""re-dislocated right shoulder"" is attributed to an underlying medical condition and assessed unrelated to BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/11/2021,2.0,PVT,,,,,,"['Joint dislocation', 'Orthosis user', 'Upper limb fracture']",2,PFIZER\BIONTECH, 1000672,NY,,U,"tested positive after receiving the first shot of the Covid-19 vaccine; tested positive after receiving the first shot of the Covid-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program, from a contactable nurse. This nurse reported similar events for three patients. This is the second of three reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0140; Expiration date: Mar2021), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive after receiving the first shot of the covid-19 vaccine. The patient underwent lab tests and procedures which included a positive Covid-19 test on an unspecified date. The outcome of tested positive after receiving the first shot of the covid-19 vaccine was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive based on the known safety profile. However the short duration of 3 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.,Linked Report(s) : US-PFIZER INC-2021050427 Same reporter, drug and event; different patient;US-PFIZER INC-2021104537 Same reporter, drug and event; different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1000677,MA,23.0,F,"Vasovagal syncope intermittent for 45 minutes, still present but remaining in a laying position",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/03/2021,02/04/2021,1.0,WRK,"Sertraline 50mg QD, probiotic, iron supplement",,,,,['Presyncope'],2,MODERNA,SYR 1000678,CA,58.0,M,This patient was given a second dose of the Moderna Covid vaccine on 4/3/21 with the vaccine administrator unknowingly unaware that the first dose had already been administered the day before on 4/2/21. The patient did not have any significant immediate side effect but the patient will be checked by the yard physician today 4/4/21 to reevaluate the patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/02/2021,02/03/2021,1.0,OTH,,,,,,"['Inappropriate schedule of product administration', 'Medication error']",UNK,MODERNA,IM 1000679,PA,58.0,F,"12 hours post-injection recipient developed a low-grade fever, body aches, and headache that lasted about 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/02/2021,02/03/2021,1.0,PVT,,,,,,"['Headache', 'Pain', 'Pyrexia']",2,MODERNA,IM 1000680,IN,78.0,M,Intermittent sharp pain in top of skull began yesterday and has moved to intermittent sharp pain in right ear. No treatment. Just waiting to see if it subsides,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/03/2021,1.0,PUB,"prednisone, irbesarten, lasix, fenesteride, flomax, baclofen, temazepam, requip, vit d, potassium, cranberry",,multiple sclerosis,,cipro et al,"['Ear pain', 'Headache']",2,MODERNA,IM 1000681,FL,73.0,F,"Red, warm, swollen, hard lump at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,PVT,"Lecothyroxin, Xarelto, timolol, metropolol",,AFib,"Same event, pneumonia booster, 2019","Steroids, opiates, codeine, sulphur, dilaudid, highly sensitive to epi Foods allergies are peanuts and shell fish","['Injection site erythema', 'Injection site mass', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 1000682,MD,67.0,F,left arm very sore several hours after vaccine and even more sore the next day,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,OTH,none,none,none,,none,['Pain in extremity'],1,MODERNA,IM 1000683,NY,61.0,F,Redness numbness and tingling in both hands Increases when hands are pointed down improves when lifted above the heart Is lessening but is clearly not listed as a side effect It is improving however is concerning more information and direction needs to be addressed several other coworkers have experienced or went to the ED with the same adverse effect. It is clearly not life threatening but I hope it will not increase with the second dose or continue in the future,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/02/2021,0.0,WRK,"synthroid botox biotin Multivitamin cortisone injections, latisse protonix","autoimmune hypothyroid, psoriasis, gerd.","autoimmune hypothyroid, psoriasis",flu vaccine 6 years ago now able to get the one without preservatives,tetracycline preservative to flu shots some metals,"['Erythema', 'Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 1000684,CO,70.0,F,Noticed aching in left hip/leg. Was out shopping and the pain progressively got worse by the time I got home was having trouble even walking. The pain seemed to be in whole leg and seemed to be muscular and also a lot of pain in hip joint area. Also was feeling a burning and numbness sensation down my leg. By 7pm was in bed because it was too painful to walk. Took 600 mg of Ibuprofen. This morning the hip pain is better and I am walking ok. I still have burning and numbness mostly in the calf area of left leg. I am also feeling burning and numbness on the left area of my lip. This is an area of my lip where I have had cold sore in past but don't see a cold sore.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/01/2021,02/03/2021,2.0,UNK,Synthroid 100mcg Cytomel 2.5 mcg Magnesium 400mg.,"I was tested for covid about a week before the vaccine. Had served on a Jury a week prior and about a week later had symptoms of sore throat, headache and fatigue. Test was negative for covid","Hypothyroid, sleep apnea",,MRI Dye - Anaphylactic Antibiotics - Approximately 5 different antibiotics,"['Arthralgia', 'Gait disturbance', 'Hypoaesthesia', 'Oral discomfort', 'Pain in extremity']",1,MODERNA,IM 1000685,,59.0,F,Headache Tongue sore; site tenderness; throat congestion Narrative: 12/25 tenderness at injection site Mild headache Tongue sore 12/26 tenderness at injection site Tongue white Visible sores under tongue...difficult to eat....very sore Throat congestion Mod headache.....took ibuprofen 3-4 times 12/27 Tongue very sore ...sores under tongue and on top and sides of tongue. Difficult to eat and talk Migraine headache.... Light sensitive...took Ibuprofen In bed majority of day Throat congestion 12/28 Exact same.....but tongue no longer white 12/29 Migraine Sores on top of tongue are gone. Sores remain under tongue and on sides of tongue Throat congestion gone 12/30 mild headache upon awakening.....back to work today 2 sores under tongue...all others are gone,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,OTH,,,,,,"['Dyspepsia', 'Glossodynia', 'Headache', 'Increased upper airway secretion', 'Injection site pain', 'Migraine', 'Photophobia']",1,MODERNA,IM 1000686,,31.0,M,1. Muscle fatigue 2. Chills 3. Headache 4. Body Ache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,MIL,,,,,,"['Chills', 'Headache', 'Muscle fatigue', 'Pain', 'Pyrexia']",2,MODERNA,IM 1000709,FL,66.0,M,"Patient with past medical history of CAD, CKD, sCHF, LGL Leukemia admitted to Hospital on 1/19 with pleural effusion. Pt expired on 2/1/2021. Hs of essential HTN, complete heart block, T2Diabetes,thyroid issues, stroke, papillary CA of thyroid, dyslipidemia, anemia, hypercalcemia, pulmonary nodule, hypoparathyroidism, pacemaker, bilat carotid stenosis, afib, pleural effusion, pancytopenia, cardiomyopathy, severe aortic stenosis, sick sinus syndrome, Dressler syndrome, empyema, ESRD",Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,,01/18/2021,02/01/2021,14.0,UNK,"amiodarone, ASA, calcitriol, coreg, folvite, apresoline, synth",see below,see below,,"Heparin, Amoxcillin","['Condition aggravated', 'Death', 'Pleural effusion']",1,PFIZER\BIONTECH,SYR 1000711,FL,81.0,M,"in addition to above, pt had the following diagnosis: portal HTN, abnormal blood chem, essential tremor, depressive disorder, abnormal glucose tolerance test, hyperlipidemia, hypothyroidism, insomnia, localized osteoarthrosis, calculus of kidney, pancytopenia, odule on liver, hepatocellular CA, hyotension, hypovolemia, hepatorenal syndrome additional meds: zoloft, aldactone, thiamine,demadex, ultram, kenalog, vitamins, bactroban ung",Yes,01/28/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/27/2021,19.0,UNK,"rocaltrol, iron, folvite, neurontin, proamatine, zifaxan","chronic liver disease, hypoganadism, alcoholic cirrhosis, cont",,,NKA,"['Blood test abnormal', 'Death']",1,PFIZER\BIONTECH,SYR 1000727,OH,42.0,F,"a week after vaccination, patient developed fatigue and weakness, SOB, eye ptosis similar to her myasthenia flares. she was admitted for IVIG and discharged 1/31",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/14/2021,01/21/2021,7.0,PVT,,,myasthenia gravis,,sulfa,"['Asthenia', 'Condition aggravated', 'Dyspnoea', 'Eyelid ptosis', 'Fatigue', 'Immunoglobulin therapy', 'Myasthenia gravis']",1,MODERNA,IM 1000733,MA,48.0,M,Ulnar nerve swelling causing entrapment at left elbow and wrist. Loss of sensation left ulnar nerve distribution 2 days after first vaccine. EMG demonstrated demyelinated neve with conduction velocity of 17 m/s. Loss of sensation. Motor weakness.,Not Reported,,Not Reported,Not Reported,,Yes,N,12/22/2020,12/24/2020,2.0,PVT,Melatonin,None,None,,NKDA,"['Asthenia', 'Demyelinating polyneuropathy', 'Electromyogram abnormal', 'Sensory loss', 'Ulnar neuritis']",1,PFIZER\BIONTECH,IM 1000738,PA,62.0,F,"PER MD: HIGH FEVER, TACHYCARDIA, HALUCINATIONS, CHANGE IN MENTAL STATUS",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/28/2021,01/29/2021,1.0,SEN,Amantadine HCl Tablet 100 MG -Give 1 tablet by mouth at bedtime clonazePAM Tablet 0.5 MG-1 tablet by mouth every 12 hours Depakote Tablet Delayed Release 250 MG -3 tablet by mouth two times a day Lithium Carbonate Capsule 150 MG -3 capsu,,TYPE 2 DIABETES MELLITUS SCHIZOPHRENIA MORBID (SEVERE) OBESITY MAJOR DEPRESSIVE DISORDER ANEMIA ESSENTIAL (PRIMARY) HYPERTENSION,,"Codeine, Keflex, Penicillins","['Hallucination', 'Mental status changes', 'Pyrexia', 'Tachycardia']",2,PFIZER\BIONTECH,IM 1000739,PA,78.0,F,"Approximately 10 minutes after receiving the COVID- 19 vaccine resident displayed seizure activity, staring straight ahead and strong allover muscle jerking of both the up and lower extremities, color became gray, activity lasted approximately 3 minutes, resident then became relaxed, color returned to normal, BP-140/80, 97.8, 60, 16, sleeping the remainder of the shift,. Resident continued to decline until resident CTB on 1/19/21",Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/05/2021,0.0,SEN,"Dermaseptin, Eucerin, Listerine, Ophthalmic Care, Periguard, Acetaminophen, Aspirin, Atorvastatin, Bisacodyl, Chlorhexidine, Memantine, MVA, Rivastigmine Patch, Trileptal Suspension, Vitamin B-50, Vitamin C, Vitamin D, zINC",NKA,"Frontotemporal Dementia, Dysphagia, Tinea Unguium, Peripheral Vascular Diseases, Difficulty Walking, Primary Hypertension, Hypercholesterolemia, Hyperlipidemia, Personality Change dur to known physiological condition, History of other mental and Behavioral Disorders, Constipation, Atherosclerotic Heart Disease of Native Coronary Artery, Nail Dystrophy, Dermatitis, Idiopathic Epilepsy and Epileptic Syndromes with Seizures of Localized Onset, Protein Caloria Malnutrition, Muscle Weakness",,nka,"['Dyskinesia', 'General physical health deterioration', 'Influenza virus test', 'Laboratory test', 'Muscle twitching', 'Pallor', 'SARS-CoV-2 test negative', 'Seizure', 'Skin discolouration', 'Staring']",1,PFIZER\BIONTECH,IM 1000749,TN,78.0,F,"pt states she always has tremors, but tremors seemed to be worse since vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/03/2021,1.0,PHM,unknown,unknown,unknown,,none listed,['Tremor'],UNK,MODERNA,IM 1000752,IN,76.0,M,"Pt son, reports patient passed away on 2/1/21 in the early hours. Pt wife, told Pt's son that patient started feeling ""bad"" with common cold like symptoms on 1/31/21, had a temp of 99.0. Pt's wife went to take a shower, when she got out patient was unresponsive. She called EMS, they pronounced patient deceased upon arrival. � Pt's son also reports patient and Pt's wife both had their 1st COVID-19 vaccine 13 days prior. He was told by EMT on sight to notify the facility where they received their vaccines. He did contact them and was told to notify PCP.",Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,01/17/2021,01/31/2021,14.0,UNK,"citalopram, atorvastatin, felodipine, avalide, metoprolol, omeprazole",none that I'm aware of,"aortic atherosclerosis, essential hypertension, depression, type 2 diabetes with stage 4 chronic kidney disease",,"penicillin, procain","['Death', 'Feeling abnormal', 'Nasopharyngitis', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH, 1000784,LA,75.0,F,T.C. from sister to communicate the hospitalization of her sister. She reported that on Friday patient collapsed and started foaming at the mouth and was rushed to hospital. She stated that patient is on a ventilator and at 5PM today they are going to take her off. Sister was very upset and I was uncomfortable asking more questions. She will call me with more information at a later time. She did say that the hospital staff was not sure of what caused her collapse.,Yes,,Not Reported,Yes,,Not Reported,,01/29/2021,01/30/2021,1.0,PUB,,,,,,"['Foaming at mouth', 'Mechanical ventilation', 'Syncope']",1,PFIZER\BIONTECH,IM 1000836,MA,60.0,F,"Patient had an anaphylactic reaction, lips and facial swelling.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/25/2021,01/28/2021,3.0,PVT,None,None,None,,Bees,"['Anaphylactic reaction', 'Lip swelling', 'Swelling face']",2,MODERNA,IM 1000840,PA,70.0,F,"Weakness, dizziness, nausea, vomiting, rash on (L) arm",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/27/2021,01/28/2021,1.0,PVT,"Atorvastatin, Fosamax, Cormax, Bactroban",COVID (+) 12/26/2020,"Hyperlipidemia, Osteoporosis, Psoriasis, Vitamin D deficiency, Thrombocytopenia",,NKDA,"['Asthenia', 'Dizziness', 'Injection site rash', 'Nausea', 'Rash', 'Vomiting']",1,MODERNA,IM 1000849,,62.0,M,"Narrative: Respiratory failure / respiratory depression went to ED / ICU 2/1/2021. Frail patient. 1st vaccine 12/23/2020 Moderna Lot 039K20A exp 6/20/2021, 2nd vaccine 1/20/2020 Moderna Lot 013L20A exp 7/8/2021",Not Reported,,Yes,Yes,,Not Reported,N,01/20/2021,02/01/2021,12.0,OTH,,,,,,"['Asthenia', 'Intensive care', 'PO2 decreased', 'Respiratory depression', 'Respiratory failure']",1,MODERNA,IM 1000856,,78.0,M,"Myocardial infarction Narrative: PMH significant for aortic valve stenosis, mitral valve stenosis, CKD, CHF, DM, HTN, obesity, hypothyroidism and dyslipidemia. Per report from primary care - the patients wife reports that the patient went on Saturday (1/30/21 - about 1050) morning to receive his COVID vaccine. He returned home and told her about the experience and denied any side effects. He then proceeded to sit in his easy chair for a while and around 1:30, she asked him if he wanted any lunch. The patient's wife reports he ""grumbled"" at her, and then got up to go to the bathroom. She then heard a loud crash and found him lying on the floor of the bathroom, with his head knocking hole in the wall as he fell. She could not detect a pulse. She called 911 and began compressions. First responders to the scene likewise tried to revive him but were not successful in her efforts. Per primary care documentation - Uncertain if related to Pfizer vaccine; vaccine administered on 1/30/21 and approximately 3 hours later suffered fatal MI at home.",Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,OTH,,,,,,"['Death', 'Fall', 'Myocardial infarction', 'Pulse absent', 'Resuscitation']",1,PFIZER\BIONTECH,IM 1000857,,59.0,M,"suspect bowel obstruction/ septic Narrative: Pt was admitted to ICU with a suspected bowel obstruction / possible sepsis 2/1/2021, Vaccine was administered 1/6/2021, Moderna Lot 039K20A Exp 6/20/2021.",Not Reported,,Yes,Yes,,Not Reported,U,01/06/2021,02/01/2021,26.0,OTH,,,,,,"['Intensive care', 'Intestinal obstruction']",1,MODERNA,IM 1000874,OH,84.0,F,"Pericarditis Tamponade. She went to the hospital with chest discomfort on the 25th and by the evening of the 26th had pericarditis to a degree that required a Pericardial Window emergency procedure. Prior to the vaccine, she was doing great with no issues. She was put on a ventilator and came through the procedure on the 27th. She was moved to rehab on February 1st, which is where she remains as of this submission.",Not Reported,,Yes,Yes,7.0,Not Reported,N,01/21/2021,01/24/2021,3.0,PUB,"Metoprolol, Lisinopril, Plavix, Pepcid, baby aspirin, daily vitamin, vitamin D",No,"Had a heart attack and stent in Sept 2020. Prior to that, no health issues.",,No,"['Cardiac tamponade', 'Chest discomfort', 'Condition aggravated', 'Mechanical ventilation', 'Pathology test', 'Pericardial excision', 'Pericarditis']",1,MODERNA,SYR 1000885,MI,65.0,M,1-7-21 - Posterior lumbar interbody fusion @ L3-4 (N/A spine lumbar) by Dr. 1-19-21 - 1st dose Pfizer Covid-19 vaccine given. 1-26-21 - Swelling of (R) calf (H/O peripheral edema) 1-29-21 - 1-31-21 - Hospitalized with DVT (R.leg) & PE (lungs bilaterally),Not Reported,,Not Reported,Yes,,Not Reported,Y,01/19/2021,01/26/2021,7.0,PVT,POTASSIUM CHLORIDE; HYDROCODONE-ACETAMINOPHEN; LISINOPRIL; NORCO; VICODIN; MAGNESIUM; IBUPROFEN; JARDIANCE; BASAGLAR KWIKPEN; METHOCARBAMOL; OMEPRAZOLE; METFORMIN; LOVASTATIN; FUROSEMIDE; AMLODIPINE; ALLOPURINOL,Posterior lumbar interbody fusion @L3-4(N/A spine lumbar) 1-7-21,LUMBAR SPINAL STENOSIS; BACK PAIN; CARPAL TUNNEL SYNDROME; DIABETES TYPE II; ERECTILE DYSFUNCTION; ESOPHAGEAL REFLUX; FAMILY HISTORY OF CAD; HYPERLIPIDEMIA; HYPERTENSION NOS; OBESITY; OBSTRUCTIVE SLEEP APNEA,,Metoprolol/Potassium Chloride Crys ER,"['Deep vein thrombosis', 'Oedema peripheral', 'Peripheral swelling', 'Pulmonary embolism']",1,PFIZER\BIONTECH,IM 1000933,TX,90.0,F,Pfizer-BioNTech COVID- 19 Vaccine EUA Patient experienced change in speech and jerky movements on way home from COVID-19 vaccine. Presented to ED. Patient diagnosed with Acute CVA (cerebrovascular accident). Patient discharged on 1/31/2021.,Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/29/2021,01/29/2021,0.0,PVT,"Cetirizine 10 mg, Cholecalciferol 25 mcg, Multivitamin, cont. Nadolol 40 mg, Fish Oil 1000 mg, Simvastatin 40 mg",,"Hypertension, High cholesterol",,"Penicillins (Wheezing), Aspirin (Shortness of breath)","['Cerebrovascular accident', 'Dyskinesia', 'Speech disorder']",2,UNKNOWN MANUFACTURER, 1000978,OK,57.0,F,"Patient report generalized body aches, numbness, and tingling. Pt. reported feeling weak all over and states that her right leg is weaker than her left leg. Pt. was brought to ER by her husband, because husband states that she was to weak to walk on her own to the bathroom. upon evaluation pt. appears tired and slightly drowsy but answers questions appropriately. The patient can state her name, where she is and the current month and year.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/30/2021,02/01/2021,2.0,OTH,,,"acute anxiety, chronic CHFw/left ventricular diastolic dysfunction, CKD stage 1, COPD, DM, HTN, Hx of stroke",,,"['Asthenia', 'Fatigue', 'Hypoaesthesia', 'Muscular weakness', 'Pain', 'Paraesthesia', 'Somnolence']",1,PFIZER\BIONTECH,SYR 1001005,ND,42.0,F,"pt became nauseated, vomiting and abdominal pain on 12/27/20 came in to be seen on 12/30/20 labs, ct and exam were performed determined pt had gallbladder flare up pt then sent to hospital where they removed gallbladder",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,12/22/2020,12/27/2020,5.0,WRK,spironolactone 25mg vitamin b 12 SL,none,diabetic well controlled no meds since weight loss htn no meds since weight loss,,latex codiene,"['Abdominal pain', 'Cholecystectomy', 'Computerised tomogram abnormal', 'Full blood count', 'Gallbladder disorder', 'Laboratory test', 'Nausea', 'Vomiting', 'X-ray']",1,MODERNA,IM 1001033,NY,24.0,F,"Patient presented for her 2nd COVID vaccine at 17:30 and indicated she had hives after the first dose of vaccine. She was pre-medicated with Benadryl 25 mg for her second dose at 17:37. Her second dose was given at 18:15 and was held at the vaccination site for observation. Pt. developed symptoms at 18:32 and c/o tightness in chest, SOB, itchiness, and hot feeling across her back and upper shoulders. Pt. indicated that she felt like ""passing out"", and was eased to the floor with Medical First Response activated. Epi 0.3 mg IM into L. Thigh and Benadryl 25mg IM on L. arm was given at 18:40. She was transported to the ED subsequently. Pt. was treated w/ decadron, famotidine in the ED and was discharged at 20:55. 2/4/2021- Doing well today overall. No further intervention after the ED visit.",Not Reported,,Yes,Not Reported,,Not Reported,U,01/29/2021,01/29/2021,0.0,PVT,"Strattera, Elavil, Allegra, Excedrin; Not taken at day of vaccine, but prescribed Depo-Provera, Imitrex PRN, Albuterol PRN.","Fatigue, Abd Pain, Palpitations w/ assoc. SOB,","ADHD, Endometriosis, PTSD, Migraine, ? Bipolar, Asthma, Food Aversion",,"Citrus, PCN, Latex,","['Chest discomfort', 'Dizziness', 'Dyspnoea', 'Feeling hot', 'Pruritus', 'Urticaria']",2,MODERNA,IM 1001094,TX,78.0,F,"12/28 Vaccination Later that evening, muscle aches and HA. 12/29 Joint pain, HA, and mild cough 12/31 Severe cough, lost voice, unable to sleep 1/2021 Urgent care; COVID test; Positive Bamlanivimab; treatment/infusion; 3 hours 15 days isolation 1/18/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,PVT,"Cintroid, lipitor",,,,seasonal allergies,"['Aphonia', 'Arthralgia', 'COVID-19', 'Cough', 'Headache', 'Insomnia', 'Myalgia', 'SARS-CoV-2 test positive']",1,MODERNA,SYR 1001169,,,U,"tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported similar events for two patients. This is the 2nd of two reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on Jan2021 (reported as either 06Jan2021 or 07Jan2021) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. This past weekend (Jan2021), the reporter, along with one other person in her office, tested positive for COVID-19 and wanted to know if they should still get their second dose or what do they recommend for that. The outcome of the events was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: The association between the event lack of effect (tested positive for COVID-19) with BNT162b2 can not be completely excluded.,Linked Report(s) : US-PFIZER INC-2021050758 Same reporter, same AE, same drug, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1001196,NY,30.0,F,"anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a nurse reporting for herself. A 30-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine , via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 prophylaxis . Medical history included ongoing asthma Diagnosed when she was a child , seasonal allergy , food allergy , contrast media allergy (gadolinium). There were no concomitant medications. The patient experienced anaphylactic reaction on 13Jan2021 with outcome of recovered , had a fever of 100.8 on 13Jan2021 with outcome of recovered. The patient underwent lab tests and procedures which included allergy test: unknown results on Jan2021 , body temperature: 100.8 on 13Jan2021. The reaction began 28 minutes later. She says she started to get jumpy, her hands swelled and got itchy. She couldn't bend her hands, they were so swollen that she couldn't bend them. Her legs were shaking. Then saline and eventually her mouth started to get numb and they used an Epi pen twice. Her throat never closed, she thinks it did not close because the Epi pen was done twice, She had 2 masks on she cannot say for sure if she had trouble breathing but her mouth began to get dry and tingly and she started to no be able to feel her mouth. She says she would says it was resolved completely the next day. The patient also received Decadron and Benadryl. The reporter would say the event were life threatening because they treat it that way due to anaphylaxis precautions. Follow up information has been requested.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,PVT,,Asthma (Diagnosed when she was a child),Medical History/Concurrent Conditions: Food allergy; Iodine contrast media allergy; Seasonal allergy,,,"['Allergy test', 'Anaphylactic reaction', 'Body temperature increased', 'Dry mouth', 'Hypoaesthesia oral', 'Mobility decreased', 'Nervousness', 'Paraesthesia oral', 'Peripheral swelling', 'Pruritus', 'Pyrexia', 'Throat tightness', 'Tremor']",1,PFIZER\BIONTECH, 1001380,NY,24.0,F,"48 hours after receiving vaccine patient awoke with left foot cramping sensation Withing another 24 hours her entire left leg was numb She took advil for 5 days with no relief and then began having severe lower back pain - dull, aching to sharp She was started on a medrol dose pak and she had relief from left foot cramping and leg numbness but at end of steroid pack she is still having lower back pain",Not Reported,,Not Reported,Not Reported,,Yes,N,01/16/2021,01/18/2021,2.0,PVT,,,,,,"['Back pain', 'Hypoaesthesia', 'Muscle spasms']",UNK,PFIZER\BIONTECH, 1001418,MA,,F,"Transient ischemic attack; A report was received from a consumer concerning a 50 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a TIA (Transient ischemic attack). The patient's medical history was not provided. The patient current condition included ulcerative colitis, blood pressure, cholesterol and acid reflux. No relevant concomitant medications were reported. On 29 Dec 2020, approximately twelve days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 026L20A) intramuscularly for prophylaxis of COVID-19 infection. The patient experienced a TIA on 10 Jan 2021. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not provided . The outcome of the event TIA was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/10/2021,12.0,UNK,,,Medical History/Concurrent Conditions: Acid reflux (esophageal); Blood pressure; Cholesterol; Ulcerative colitis,,,['Transient ischaemic attack'],1,MODERNA,OT 1001419,TX,,F,"Seizures; bumps on her right arm; red big spots on her right arm; Fever; A spontaneous report was received from a caregiver concerning a 55-years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced seizures, fever, and red spots and bumps on her arm. The patient's medical history, as provided by the reporter, included being non-verbal, unable to walk, and seizures that last 1-2 seconds. No relevant concomitant medications were reported. On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 041L20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. The reporter was a consumer who holds a foster care for older patients. This patient was under her care at the time of the report. The patient received the Moderna Covid-19 vaccine on 13 Jan 2021 at 10 A.M. at the foster care location. She did not notice any reaction after administration. That evening, she saw two big red spots and bumps on her right arm. She iced the patient's arm, but the redness was still visible and bumps were present. That night, the patient started a fever of 102 degrees Fahrenheit. The reporter iced her body down and gave her paracetamol, which helped. She reported that there was no vomiting. On 14 Jan 2021, in the morning the patient had a seizure that lasted 30 mins. The reporter stated that she usually does not call 911 because she is familiar with the patient's seizures that last between 1-2 seconds, but this led her to call emergency services. The seizure was gone when they arrived, and she continued to care for the patient at the home. On 16 Jan 2021, the seizure returned. She had another seizure on 18 Jan 2021, which was concerning, per the reporter because of their frequency. She contacted the patient's health care provider who did not advise anything. She scheduled an appointment with a neurologist. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, seizures, fever, and red spots and bumps on her arm, was not reported.; Reporter's Comments: This case concerns a 55-year-old female patient with a significant medical history of seizures who experienced a medically significant and unexpected event of Seizure and non-serious unexpected event of Injection site papule along with non-serious expected events of Injection site erythema and Pyrexia. The event of Seizure occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (041L20A), which returned on day 3 and 5 after vaccination. The events of Injection site erythema, Injection site papule and Pyrexia occurred on the same day after receiving their first of two planned doses of mRNA-1273 (041L20A). Treatment for pyrexia included iced her body down and Tylenol. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. Of note, patient's prior history of seizures is considered a confounding factor for the event of seizure.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/13/2021,0.0,UNK,,Seizures (Last 1-2 seconds); Speech loss; Unable to walk,,,,"['Condition aggravated', 'Injection site erythema', 'Injection site swelling', 'Pyrexia', 'Rash', 'Seizure']",1,MODERNA,OT 1001421,LA,77.0,F,"Ischemic attack; Severe high blood pressure; A spontaneous report was received from a consumer concerning a 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe high blood pressure (BP) and ischemic attack. The patient's medical history included diabetes. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin calcium, bupropion hydrochloride, gabapentin, ibuprofen, estradiol and metformin. On 08 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Jan 2021, the patient was taken by ambulance to the hospital with severe high BP. During her hospital stay the patient's BP readings were 190s/109. The patient was diagnosed with ischemic attack. On 14 Jan 2021, the patient was discharged from the hospital. Her BP readings since then have been 179/85. On 19 Jan 2021, the patient's BP reading was 145/80. Treatment for the event included lisinopril. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events, severe high BP and ischemic attack, was considered unknown.; Reporter's Comments: This case concerns a 77-year-old female patient with medical history of diabetes who experienced the serious unlisted events of Hypertension and Transient ischaemic attack that required hospitalization. The events occurred approximately four days after receiving their first of two planned doses of mRNA-1273 (Lot number: 027L20A), Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. Of note, patient's elderly age and history of diabetes are considered risk factors for the occurrence of the events.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/08/2021,,,UNK,LIPITOR; WELLBUTRIN; GABAPENTIN; IBUPROFEN; ESTRADIOL; METFORMIN,Diabetes,,,,"['Hypertension', 'Transient ischaemic attack']",1,MODERNA,OT 1001422,AZ,25.0,F,"she was blacked out for a good 30-40 seconds; drenched and very sweaty; extremely hot; nauseated; A spontaneous report was received from a consumer concerning a 25-year-old, female patient who received Moderna's COVID-19 vaccine and experienced blacking out, nausea, feeling extremely hot and sweaty. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included desogestrel-ethinylestradiol for birth control. On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011LZ0A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 16 Jan 2021, one day after the vaccination, the patient was found in the bathroom unconscious. The patient reported feeling very nauseated, extremely hot and drenched with sweat prior to blacking out. The duration of the blackout was approximately 30 to 40 seconds. Patient states she was washing hands, about to plug something in and next thing she knows she is being rolled over by her husband. Treatment information was not provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events, blacking out, nausea, feeling extremely hot and sweaty, was not provided.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/16/2021,1.0,UNK,ISIBLOOM,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Feeling hot', 'Hyperhidrosis', 'Loss of consciousness', 'Nausea']",1,MODERNA,OT 1001424,NJ,,M,"Anaphylactic reaction; Had severe itching in the whole body; chills; A spontaneous report was received from a physician concerning a 80-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced anaphylactic reaction, severe itching in the whole body and chills. The patient's medical history was not provided. Concomitant medications reported included tamsulosin, omperazole, simvastatin, amlodipine and finasteride all for unknown indications. On an unknown date, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number 01120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced severe itching and chills for about a day following vaccination. 2 days following vaccination, the subject experienced an anaphylactic reaction. He sought medical attention from his dermatologist who gave him the diagnosis. Treatment for the event included sertac at night, claritin in the morning, and betamethasone 0.05% cream. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events anaphylactic reaction, severe itching in the whole body and chills were unknown.; Reporter's Comments: This case concerns a 80-year old, male patient, who experienced a serious unexpected event of anaphylactic reaction and pruritus (had severe itching in the whole body), and a non-serious expected event of chills. The event of anaphylactic reaction occurred 2 days after first dose of mRNA-1273, lot # 011L20A. The event of, pruritus and chills occurred on an unspecified date after first dose of mRNA-1273, lot # 011L20A. Treatment included Sertac-one pill at night, Claritin- one pill in the morning and Betamethasone dipropionate 0.05% cream. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.",Not Reported,,Yes,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,TAMSULOSIN; PRILOSEC [OMEPRAZOLE]; SIMVASTATIN; AMLODIPINE; FINASTERIDE,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Anaphylactic reaction', 'Chills', 'Pruritus']",1,MODERNA,OT 1001425,NY,,F,"Developed cellulitis at the injection site; Injection site red; Injection site inflamed; Slight reaction; A spontaneous report was received from a healthcare professional concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a slight reaction, developed cellulitis at the injection site, injection site red and injection site inflamed. The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient received the vaccine and had a slight reaction for one or two days. About five days later, the patient developed cellulitis at the injection site that was red and inflamed. Treatment for the event included antibiotics. Action taken with mRNA-1273 in response to the events was not reported. The event, slight reaction, was considered resolved on 13 Jan 2021. The outcome of the events, developed cellulitis at the injection site, injection site red and injection site inflamed were unknown.; Reporter's Comments: Company Comment: This spontaneous report concerning a female patient who experienced unexpected serious event of cellulitis at the injection site and non-serious events of injection site red and injection site inflamed. The events occurred approximately 5 days after the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). The events are temporally associated with the vaccine administration and in the absence of any other etiology, a causal association between these events and the administration of mRNA-1273 vaccine cannot be excluded. The non-serious events of injection site redness injection site inflamed, and injection site reaction are consistent with the known safety profile of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Injection site cellulitis', 'Injection site erythema', 'Injection site inflammation', 'Injection site reaction']",1,MODERNA,OT 1001427,AL,,M,"Anaphylactic shock; A spontaneous report was received from a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic shock. The patient's medical history was not provided. Concomitant product use was not reported. On an unspecified date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced a severe reaction to the vaccine that resulted in being transported to the emergency room and treated for anaphylactic shock. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, anaphylactic shock, was unknown.; Reporter's Comments: This case concerns a male patient of unknown age with unknown medical history subject, who experienced a serious unexpected event of anaphylactic shock. The event occurred on unspecified time after the first dose of mRNA-1273 vaccine. Treatment information was reported; however, patient was transported to emergency room. Outcome of reported anaphylactic shock is unknown. The event was assessed as possibly related, however additional information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (no medical history provided),,,['Anaphylactic shock'],1,MODERNA,OT 1001428,NY,48.0,F,"Anaphylactic reaction; Scratchy throat; Pain-near injection site; A spontaneous report was received from a consumer concerning a 48-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced anaphylactic reaction, scratchy throat and pain near the injection site. The patient's medical history included COVID-19. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) on 06 Jan 2021 in the left arm intramuscularly for prophylaxis of COVID-19 infection. On 06 Jan 2021, almost immediately after receiving the vaccine the patient reported having a scratchy throat and pain near the injection site. She stated she spoke with her health care provider who advised her she was having an anaphylactic reaction. Treatment for the event included Benadryl. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events anaphylactic reaction, scratchy throat and pain near the injection site were unknown.; Reporter's Comments: This case concerns a 48-year-old female patient. The patient experienced an unexpected event of Anaphylactic Reaction that was considered medically significant, and an unexpected non-serious event of Scratchy throat along with an expected non-serious event of pain near the injection site. The events occurred almost immediately after receiving first dose of first of two planned doses of mRNA-1273 (Lot number 039K20-2A) in the left arm intramuscularly for prophylaxis of COVID-19 infection. Treatment included Benadryl. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Anaphylactic reaction', 'Immediate post-injection reaction', 'Injection site pain', 'Oropharyngeal discomfort', 'Throat irritation']",1,MODERNA,OT 1001429,MA,,M,"Erythema multiform minor of hands and feet; A spontaneous report was received from a healthcare professional concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed erythema multiform minor of hands and feet. The patient's medical history was not provided. No relevant concomitant medications were reported. On 24 Dec 2020, approximately 7 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 31 Dec 2020, the patient developed erythema multiform minor of hands and feet mostly. On 19 Jan 2021, the patient had a telehealth visit with an allergist, who confirmed the diagnosis. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, erythema multiform minor of hands and feet was unknown.; Reporter's Comments: This case concerns a male patient of unknown age. The medical history and concomitant medication is not provided. The patient experienced an unexpected and medically significant event of Erythema multiforme. The event occurred approximately seven days after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Treatment details were not provided. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/31/2020,7.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Erythema multiforme'],1,MODERNA,OT 1001430,NH,50.0,M,"Bell's Palsy/ Facial paralysis/ Dropiness on the rightside; Light sensitivity; Tearing; Felt like flu; Sore; A spontaneous report was received from a 50 year-old, male patient who received Moderna's COVID-19 vaccine and experienced sore, felt like had the flu, light sensitivity, tearing of his right eye, Bell's palsy (right eye won't blink on its own, lip and speech issues). The patient's medical history was not provided. Concomitant medications were not reported. On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A), intramuscularly in left arm, for prophylaxis of COVID-19 infection. On 10 Jan 2021, he was sore, felt like had the flu. On 13 Jan 2021, he experienced light sensitivity, and tearing of his right eye. On 19 Jan 2021, he went to the emergency room and found with facial paralysis, droopiness on the right side. He was diagnosed with Bell's palsy (right eye won't blink on its own, lip and speech issues). Treatment included Valtrex. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, sore, felt like had the flu was considered resolved on 11 Jan 2021. The outcome of the event, Bell's palsy (right eye won't blink on its own, lip and speech issues) was not recovered. The outcome of the events, light sensitivity, and tearing of right eye was unknown.; Reporter's Comments: This case concerns a 50-year-old male patient. The medical history is not provided. The patient experienced a medically significant and unexpected event of Facial paralysis and unexpected non-serious events of Influenza, Pain, Photophobia and Lacrimation increased. The events of Influenza and Pain occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot number: 025J20A). Photophobia and Lacrimation increased occurred approximately four days after the first dose of mRNA-1273 (Lot number: 025J20A). Event of Facial Paralysis was diagnosed approximately ten days after the first dose of mRNA-1273 (Lot number: 025J20A). Treatment included Valtrex. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/10/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Dizziness', 'Eyelid function disorder', 'Facial paralysis', 'Influenza like illness', 'Lacrimation increased', 'Lip disorder', 'Pain', 'Photophobia', 'Sensitive skin', 'Speech disorder']",1,MODERNA,OT 1001432,PA,,F,"Swollen Tongue; A spontaneous report was received from a consumer concerning a 63-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who experienced swollen tongue. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 31 Dec 2020, approximately 3 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 02 Jan 2021, patient experienced swollen tongue. Treatment for the event included Benadryl. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, swollen tongue was not reported.; Reporter's Comments: This case concerns a 63-years old female patient with unknown medical history subject, who experienced a serious unexpected event of swollen tongue. The event occurred three days after first dose of mRNA-1273 vaccine. Treatment for the event included Benadryl.; however, outcome wasn't reported. The event was assessed as possibly related due to temporal association, however additional information has been requested.",Not Reported,,Yes,Not Reported,,Not Reported,U,12/31/2020,01/02/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Swollen tongue'],1,MODERNA,OT 1001433,IL,63.0,M,"Symptoms of an enlarged spleen; Blood in stool that lasted 3 days; General tiredness; A spontaneous report was received from a dentist, a 63 year-old male patient, who received Moderna's COVID-19 Vaccine and experienced general tiredness, blood in stool that lasted 3 days, and symptoms of an enlarged spleen. The patient's medical history, as provided by the reporter, included high blood pressure. No relevant concomitant medications were reported. On 04 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (batch number 026L20A) intramuscularly in the left arm for COVID-19 infection prophylaxis. On 04 Jan 2021, the patient had general tiredness. On 16 Jan 2021, the patient experienced blood in his stool. On 17 Jan 2021, the patient had symptoms of an enlarged spleen. He stated that he had intense pain on the side of the spleen. Treatment for the events included ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, blood in stool that lasted 3 days, was considered resolved on 19 Jan 2021. The outcome of the event, symptoms of an enlarged spleen, was considered resolved on 19 Jan 2021. The outcome of the event, general tiredness, was considered unknown.; Reporter's Comments: This case concerns a 63-years-old male patient, who experienced a medically significant unexpected event of blood in his stool, and non-serious unexpected event of Symptoms of an enlarged spleen along with expected non-serious event of General tiredness. General tiredness occurred on the same date after the first dose of mRNA-1273, lot # 026L20A. The event of blood in his stool occurred approximately 12 days after first dose of mRNA-1273, lot # 026L20A. The event of Symptoms of an enlarged spleen occurred approximately 13 days after first dose of mRNA-1273, lot # 026L20A. Treatment for the events included ibuprofen. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,,Blood pressure high,,,,"['Fatigue', 'Haematochezia', 'Pain', 'Splenomegaly']",1,MODERNA,OT 1001434,NJ,,F,"Angioedema in the face; Redness in the face; A spontaneous report was received from a 37 year-old, female, nurse who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angioedema in the face and redness in the face. The patient had a medical history of allergy to a lot of chemical compounds. No relevant concomitant medications were reported. On 05 Jan 2021, 48 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026AL20A) intramuscularly for prophylaxis of COVID-19 infection. On 07 Jan 2021, 48 hours after receiving the vaccine, the patient started with angioedema and some redness on the skin in her face. She stated it lasted for a complete week. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The events angioedema in the face and redness in the face were resolved on 15 Jan 2021.; Reporter's Comments: This case concerns a 37-year-old female patient with relevant medical history of allergy to chemicals who experienced an unexpected medically significant event of Angioedema and an unexpected non-serious event of Erythema. The events occurred approximately 48 hours after receiving first dose of mRNA-1273 (Lot number: 026AL20A). Based on the current available information and temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. Patient's prior history of allergy to chemicals may have been contributory.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/07/2021,2.0,UNK,,Allergy to chemicals,,,,"['Angioedema', 'Erythema']",1,MODERNA,OT 1001436,,,F,"Losing consciousness; Dizziness; Vomiting; Nausea; A spontaneous report was received from a consumer, who was also a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced nausea, vomiting, dizziness, and losing consciousness. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 18 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 18 Jan 2021, the patient reported having nausea and vomiting all night. Additionally, she also experienced dizziness and losing consciousness. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events nausea, vomiting, dizziness, and losing consciousness was unknown.; Reporter's Comments: This spontaneous report concerns a female patient who experienced a serious event of losing consciousness and non-serious events of nausea and vomiting. The events occurred on the same day after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: Unknown, expiration date-Unknown). No treatment was reported, and outcome is unknown. Based on the information provided, which includes a strong temporal association between the reported events and the administration of mRNA-1273 vaccine, a causal association cannot be excluded. Nausea and vomiting are consistent with the known safety profile of mRNA-1273 vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,01/18/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Dizziness', 'Loss of consciousness', 'Nausea', 'Vomiting']",1,MODERNA,OT 1001437,,,M,"erectile dysfunction; nausea; vomiting; fever; This is a spontaneous report from a contactable Nurse reporting for himself A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 19Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date the patient started experiencing side effects of nausea and vomiting. On an unspecified date (yesterday) he experienced a fever and last night (as reported) had erectile dysfunction. At the time of the reporting event outcome was unknown. Information about lot/batch number has been requested.; Sender's Comments: Erectile dysfunction more likely represents a coincidental medical condition unrelated to the vaccine use because of the absence of a biological plausibility. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,,,UNK,,,,,,"['Erectile dysfunction', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH, 1001438,CT,,F,"Stroke; This is a spontaneous report from a contactable consumer. A 92-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. Facility type vaccine was Nursing Home/Senior Living Facility. The patient medical history was not reported. No Covid prior vaccination. Concomitant medications included unspecified other medications received in two weeks. The patient experienced stroke on 13Jan2021. AE resulted in ''Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization''. The patient was hospitalized from Jan2021 to Jan2021 for 2 days for stroke. Patient not received other vaccine in four weeks. Patient was not pregnant. Therapeutic measures were taken as a result of stroke. The outcome of event was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/08/2021,01/13/2021,5.0,SEN,,,,,,['Cerebrovascular accident'],1,PFIZER\BIONTECH, 1001441,VA,44.0,M,"Migraine; body aches; a headache; nausea; right ear became clogged, and today he can hardly hear anything out of his right ear.; sluggish; kind of tired/felt fatigued; The injection site was sore; This is a spontaneous report from a contactable consumer. This 44-year-old male consumer (Patient) reported that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176) at single dose for COVID-19 immunisation on 19Jan2021. The vaccination was given at 08:15-08:30. He assumed the anatomical location of administration was the muscle in his left shoulder (left arm). Relevant history included back surgery with nerve impact. He was just a big guy. Family medical history was none. Relevant concomitant drugs included Gabapentin 600 mg due to back surgery with nerve impact for 2 years, and Generic cholesterol medication for High cholesterol for years. The patient received the vaccine on Tuesday morning (19Jan2021). He reported that he was kind of tired and the injection site was sore, but nothing significant. He experienced being tired and fatigued at 20:00 and progressively got worse, by Wednesday (20Jan2021), he was more sluggish. On 20Jan2021, he had a headache, nausea and body aches at 10:00. In the evening, his right ear became clogged/""clouded"" or muffled, and on 21Jan2021 he could hardly hear anything out of his right ear at 17:00- 18:00. The tiredness got significantly worse on Wednesday, but it had improved on 21Jan2021. The headache lasted about 12 hours, but it was better. The nausea also started with the headache. It was persisting, but mild. The body aches progressively got worse and were gone at the reporting time. He took Treximet for Migraine around 14:00 on 20Jan2021. NO ER or physician's office required. Depending on what he finds out on 21Jan2021, he will go see someone. The outcome of events Tired and fatigued, Body aches, headache, injection site was sore was Resolving, the outcome of events Nausea, Right ear became clogged and can hardly hear anything out of it was not resolved. The muffled ear maybe even worse on 21Jan2021. The outcome of other events was unknown. There was no additional Vaccines Administered on the Same Date of the Pfizer Suspect. No history of previous immunization with the Pfizer vaccine considered as suspect. Prior Vaccinations (within 4 weeks) was none. Relevant test was none.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,PVT,GABAPENTIN,,Medical History/Concurrent Conditions: Back surgery; Nerve injury,,,"['Ear discomfort', 'Fatigue', 'Headache', 'Hypoacusis', 'Injection site pain', 'Migraine', 'Nausea', 'Pain', 'Sluggishness']",UNK,PFIZER\BIONTECH, 1001442,MO,81.0,F,"pain on her left shoulder where they gave her the shot/had pain where they she had the injection in her arm; To the point where she felt like she ""was going to pass out""; kind of weak/ having ""no energy""/ she does not seem to have the energy/ it just droopy; felt dizzy; She has not been sleeping good; having a funny feeling; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), intramuscularly on 15Jan2021 16:15 at single dose in left arm for COVID-19 immunization. Medical history provided as none. There were no concomitant medications. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. There were no vaccines received within 4 weeks Prior Vaccinations. The reporter stated she received the first dose of the COVID-19 vaccine on 15Jan2021 (Friday) and felt fine. She added it then made her kind of weak on next Saturday morning on 16Jan2021, to the point where she felt like she was going to pass out on 16Jan2021, but it went away after laying down. She stated she felt pain on her left shoulder where they gave her the shot on 20Jan2021 but is fine today (21Jan2021). Lastly, she mentioned having no energy. She asked if her symptoms were reported sided effects of the vaccine. She has been having a funny feeling in Jan2021 and does not know if it is from the vaccine. She clarifies that she does not seem to have the energy on 16Jan2021. When she got home she was ok, the next day after she got the shot, she thought she was going to pass out and felt dizzy for about an hour on 16Jan2021. She has not been sleeping good for the last few days since Jan2021 and states that may be why she does not have the energy. For event does not seem to have energy, reports it comes and goes, states it just droopy and it may be she had pain where they she had the injection in her arm on 20Jan2021. She is asking if this is normal. The patient declined any Treatment. The reported adverse events did not require a visit to Emergency Room and Physician Office. The reported stated it wasn't that bad. The outcome of event Dizzy was recovered on 16Jan2021. The outcome of the event ""was going to pass out"" was recovered in Jan2021. The outcome of event ""pain on her left shoulder where they gave her the shot/had pain where they she had the injection in her arm"" was recovered on 21Jan2021. The outcome of event 'kind of weak/ having ""no energy""/ she does not seem to have the energy/ it just droopy' was not recovered. The outcome of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/01/2021,,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE,,,"['Asthenia', 'Dizziness', 'Feeling abnormal', 'Injection site pain', 'Sleep disorder']",1,PFIZER\BIONTECH,OT 1001444,TX,38.0,M,"headache; sweating; neck was stiff; passed out for about 5-10 seconds; body ache; really bad chills; fever 100.4; unable to sleep; This is a spontaneous report from a contactable Consumer (patient). A 38-years-old male patient started to receive 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, Expiry Date: 01Mar2021), via an unspecified route of administration at Left arm on 30Dec2020 18:17 at SINGLE DOSE for covid-19 immunisation. Patient's Medical History (including any illness at time of vaccination) was none. There were no concomitant medications. Prior Vaccinations (within 4 weeks) was reported as 'None' and AEs following prior vaccinations was reported as 'None'. AE(s) following prior vaccinations was reported as None. The patient experienced really bad chills, body aches, fever, unable to sleep on 31Dec2020 with outcome of recovered on 01Jan2021, passed out on bathroom floor for 5-10 seconds, sweating and neck was stiff on 01Jan2021 with outcome of recovered on 01Jan2021, headache on an unspecified data with outcome of unknown. Details were as follows: the patient received the Covi-19 vaccine 30Dec2021. He had a reaction to the vaccine. 24 hours after getting the vaccine he had really bad chills, body aches, fever 100.4. He didn't take any medication for a bit. He then took acetaminophen (TYLENOL). He had a headache, he was unable to sleep. The acetaminophen worked and he went to bed. At 5:00 am he started having a bad headache and took Ibuprofen. He woke up to go to the bathroom. He passed out for 5-10 seconds in the bathroom. His head was leaning in the wall by the door. He was sweating and was stiff all over. He went to the Emergency Room on 01Jan2021. They did an X-ray and a CT scan. They gave him 100ml of saline and some pills. They also did some lab work. Everything was negative. They assumed his body couldn't handle the vaccine. He was supposed to have received the second shot yesterday (20Jan2021). Employee Health said his Primary Care Physician would have to make the decision on him taking it or not. His doctor said he would have to do more research with Pfizer before he says if he can take it or not. Emergency Room visit required due to event passing out.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Computerised tomogram normal', 'Headache', 'Hyperhidrosis', 'Incomplete course of vaccination', 'Insomnia', 'Laboratory test normal', 'Loss of consciousness', 'Musculoskeletal stiffness', 'Pain', 'Pyrexia', 'X-ray normal']",1,PFIZER\BIONTECH, 1001451,NY,22.0,M,I took both doses of the pfizer vaccine and noticed that my thumb joints and my right wrist started to hurt. It hasn't resolved and it seems to not be getting any better,Not Reported,,Not Reported,Not Reported,,Yes,,01/23/2021,01/23/2021,0.0,UNK,,,,,,"['Arthralgia', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 1001467,MT,,M,"I needed up get the Pfizer vaccine on Dec 23, 2020 since I worked in a Long Term Care Facility in a remote village and was scheduled to receive the next vaccine on Jan 6, 2021. However, I was released from my job on Jan 1, 2021. On Jan 4th, 2021, I was flown to another city. I spent some time there. Then, on Jan 16th, 2021, I landed in another city and checked in to a hotel. The next day, I was tested for the Corona Virus via nasal swab. The following day, they called me and said my test came back positive and said I had to quarantine for 10 days. I had minor pneumonia symptoms, but I felt they were not bad enough for me to go to the hospital. My symptoms were gone in about 5 days. I left being quarantine on Jan 30th, 2021.",Not Reported,,Yes,Not Reported,,Not Reported,,12/23/2020,01/19/2021,27.0,UNK,Duloxetine 60 mg,alcohol use,,,pollen and dust,"['COVID-19', 'Pneumonia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1001488,TX,60.0,F,Patient died several days after receiving the second dose of the vaccine. See additional information sent. An autopsy has been performed and results are pending.,Yes,01/31/2021,Not Reported,Not Reported,,Not Reported,,01/18/2021,01/31/2021,13.0,UNK,,COVID infection November 2020,"HTN, Afib, atherosclerotic cardiovascular disease;",,,"['Autopsy', 'Death']",2,UNKNOWN MANUFACTURER, 1001494,TN,68.0,M,"COVID-19 vaccine: arm pain/his arm was sore; Cough; postponed getting the second dose of the COVID-19 vaccine until 90 days after getting the infusion; postponed getting the second dose of the COVID-19 vaccine until 90 days after getting the infusion; COVID-19 molecular test: positive/COVID-19 PCR test: positive; COVID-19 molecular test: positive/COVID-19 PCR test: positive; This is a spontaneous report from a contactable physician (patient). A 68-year-old male patient received first dose of bnt162b2 (Batch/lot number: EL1284), via an unspecified route of administration in left arm on 31Dec2020 at single dose for covid-19 immunization. Medical history included ongoing hyperlipidaemia (this was diagnosed about 10 years ago), nasal spray, borderline thyroid, coronary artery disease (very mild, it was diagnosed a couple years ago) all from an unknown date and unknown if ongoing. Concomitant medication included montelukast, levothyroxine sodium (SYNTHROID) at 75mcg for his borderline thyroid, levothyroxine. The patient experienced covid-19 molecular test: positive/covid-19 PCR test: positive on 06Jan2021, covid-19 vaccine: arm pain/his arm was sore, cough on an unspecified date. The events were reported as non-serious. Caller said he got the first dose of the COVID-19 vaccine on 31Dec2020 on New Years Eve, and then on 06Jan2021 came down with COVID, then subsequently got the Eli Lilly monoclonal antibodies infusion and has postponed getting the second dose of the COVID-19 vaccine until 90 days after getting the infusion, which means second dose will be 08Apr2021. He said since he is 68 he qualified to get the infusion on Jan 8th. He said that the monoclonal antibodies infusion they recommend you didn't get the second vaccine dose until 90 days after receiving the antibodies. He got the vaccine through work, but he thinks that the (Vaccination Facility Name) provided it, they were 1B at the time for physicians to get it, so it was given through hospital employee health department. On 06Jan2021 he had two positive tests, a rapid and a send out, rapid was a molecular COVID test and the send out was a PCR, he was pretty sure both were positive. He said it was on 08Jan2021 he got the infusion of the Eli Lilly monoclonal antibodies. when he had COVID, he had no fevers, he had a cough just like a cold, and the only reaction he had from getting the vaccine was his arm was sore, he did no treatment for either of these. Eli Lilly monoclonal antibodies infusion: He said that it says it is a BAM LAM IV IMAB infusion, and it was infused over an hour on Jan 8th. Caller says he has had no new medications or recent vaccinations, he had the flu shot in Aug or Sep. The event was not required the initiation of new medication or other treatment or procedure. He hasn't had repeat tests, it has been 10 days from diagnosis and his symptoms have resolved. He also has got allergic rhinitis, so he takes three nasal sprays and Montelukast, medication came in an orange pharmacy. He took generic levothyroxine sodium (SYNTHROID) 75mcg for his borderline thyroid. He took Levothyroxine 88mcg, they upped it. Levothyroxine NDC: 65862-57490, LOT: 57420095A1, EXP: Jul2023. Not any pre-existing diseases worsened during the SARS-CoV2 infection. The patient hadn't been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 06Jan2021, COVID-19 molecular test: positive on 06Jan2021. The outcome of events for covid-19 molecular test: positive/covid-19 PCR test: positive was resolved in Jan2021, for other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19, suspected LOE and other events due to temporal relationship. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,01/06/2021,6.0,PVT,MONTELUKAST; SYNTHROID; LEVOTHYROXINE,Hyperlipidemia (this was diagnosed about 10 years ago.),"Medical History/Concurrent Conditions: Coronary artery disease (very mild, it was diagnosed a couple years ago.); Nasal allergy; Thyroid disorder",,,"['COVID-19', 'Cough', 'Pain in extremity', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1001505,KY,47.0,M,"Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs) received from contactable pharmacists reported for a 47-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at 0.3 ml, single for covid-19 immunisation. There were no medical history and concomitant medications. The patient received the first dose of the vaccine and then few days later in Jan2021, tested positive for COVID. The patient was scheduled for the second dose this weekend, on Saturday. They wanted to know what the patient should do and if he should get the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1001537,OH,56.0,F,Heart palpitations/racing heart. Dr. Appointment scheduled.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,02/02/2021,3.0,OTH,"Albuterol, atorvastatin, alendronate, argocaliferol, lisinopril,",,"Athsma, anxiety, depression, hypertension , seasonal allergies, vertigo.",,Penicillin causes yeast infections.,['Palpitations'],1,PFIZER\BIONTECH,SYR 1001543,MA,47.0,F,"positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable Nurse(patient). A 47-year old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscularly on 16Jan2021 08:00 at single dose left arm, and first dose(lot number EK5730), intramuscularly on 29Dec2020 08:00 at single dose, left arm for covid-19 immunization. The patient's medical history and concomitant medications reported as no. Family medical history reported as no. Patient had a negative COVID test on 29Dec2020 prior to receiving the COVID-19 Vaccine. She received first dose of Pfizer COVID-19 Vaccine on 29Dec2020. Second dose of COVID-19 Vaccine received on 16Jan2021. She said that she tested negative after the 1st dose. The patient had a positive COVID test on 18Jan2021. The patient had not had any contact with positive patients or people. Seriousness reported as medically significant because she didn't know what comes of it. Causality reported as yes because she had no contact with anyone who had been COVID positive. Her whole family had been tested and were COVID negative. The patient tried to google it and even a couple nurses wondered if caller's positive COVID test had anything to do with caller's COVID-19 Vaccines. Caller stated she was asymptomatic. She only received the COVID-19 test because she was testing her children. Her children's COVID tests were negative. Caller was highly suspicious it came back as a positive result. Patient didn't know if it was a lab error or the vaccination process and the way the immune system works. COVID test performed was a PCR nasal swab. The outcome of the event was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,01/18/2021,2.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,OT 1001548,IN,,F,"COVID vaccine] treatment under Emergency Use Authorization(EUA): patient experienced shortness of breath and chest pain the day following the vaccine. The patient was hospitalized and received a stent. Unable to rule out vaccine playing a role, so it is being reported.",Not Reported,,Not Reported,Yes,,Not Reported,,01/26/2021,01/29/2021,3.0,UNK,,,"HTN, HLD, T2DM, anemia, stent placed in 2015",,,"['Chest pain', 'Dyspnoea', 'Stent placement']",UNK,MODERNA, 1001567,IL,81.0,M,Death 100.4, chills, extreme joint pain and swelling along with enlarged and swollen axillary lymph nodes on the L side. I was extremely fatigued and nauseated for more than there days. Since then, I have had abdominal issues including acid reflux and nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/30/2021,01/30/2021,0.0,WRK,,,,"Prolonged fatigue, nausea and extreme migraines for up to four days post administration.",Yellow Dye # 5 & # 6,"['Abdominal discomfort', 'Arthralgia', 'Chills', 'Diarrhoea', 'Fatigue', 'Gastrooesophageal reflux disease', 'Joint swelling', 'Lymphadenopathy', 'Nausea', 'Pyrexia', 'Vomiting']",2,MODERNA,IM 1003713,FL,65.0,F,Large bright red circle with lump in the middle. Was itchy and warm to the touch. Lasted 2-3 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/30/2021,11.0,PVT,Lisinipril HCL 20mg Omeprazole 40 mg Aspirin 80mg Probiotic Calcium 1100mg,None,Gerd Sleep apnea High blood pressure Vaso motor disease,,None,"['Mass', 'Pruritus', 'Rash erythematous', 'Skin warm']",1,MODERNA,SYR 1003714,CA,54.0,F,"?Covid Arm? - Round, itchy, red circle at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,02/01/2021,31.0,PHM,None,None,Mild Kidney disease,,Sulfa - headache,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,SYR 1003715,NY,72.0,F,"Large red, itchy bump.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/30/2021,1.0,PVT,"Losartan, Wellbutrin, Lithium, Primidone, Mybetrique",,"Asthma, High Blood Pressure",itch at shot sight,,"['Rash erythematous', 'Rash pruritic']",UNK,MODERNA,IM 1003717,,18.0,F,Rash at injection site and muscle aches. Was achy on the morning of 1/28/2021 with 'bumps' on the chest area. Achiness resolved on 1/29/2021 but rash continued affecting her abdomen as well.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/27/2021,02/04/2021,8.0,WRK,,,,,,"['Injection site rash', 'Myalgia', 'Pain', 'Rash']",2,PFIZER\BIONTECH,IM 1003718,CA,72.0,F,". patient received vaccine on1/22/2021 . Patient had skin rash on 1/27/2021 below neck , macular rash which was not itchy or painful. patient did not take any medication for it . no fever. no oral lesions or angioedema she is recovering from it without treatment",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/01/2021,,PUB,"Tylenol, Norvasc, aspirin,lipitor,calcium , Prilosec,",none,"hypertension, H/O stroke, hyperlipidemia , rt eye cataract Fatty liver, malignant neoplasm of breast-2012 osteopenia",,none known,"['C-reactive protein increased', 'Liver function test increased', 'Rash', 'Rash macular', 'Red blood cell sedimentation rate increased']",1,MODERNA,IM 1003931,,30.0,M,New onset complex migraine headaches requiring admission to hospital for intractable pain for 1 week along with focal neurological symptoms with right sided weakness of upper and lower extremity that resolved.,Not Reported,,Not Reported,Yes,7.0,Not Reported,Y,01/31/2021,02/01/2021,1.0,PVT,,,,,,"['Hemiparesis', 'Migraine', 'Neurological symptom', 'Pain']",2,PFIZER\BIONTECH,IM 1004198,OR,62.0,F,"hemorrhoid pain; bloody diarrhea; severe diarrhea; Nausea; abdominal pain; shaking chills; Severe leg cramps; A spontaneous report was received from a 62 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe leg cramps, severe diarrhea, nausea, abdominal pain, shaking chills, hemorrhoid pain and the serious event of bloody diarrhea. The patient's medical history included diverticulitis. No relevant concomitant medications were reported. On 22 Dec 2020, about 4pm, the patient received their first of two planned doses of mRNA-1273 (Lot #011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 22 Dec 2020, around 7pm, the patient experienced severe leg cramps. On 23 Dec 2020, she experienced severe diarrhea, nausea, abdominal pain, shaking chills and bloody diarrhea. Treatment for nausea was ondansetron. On 24 Dec 2020, the patient experienced terrible hemorrhoid pain and abdominal pain. On 25 Dec 2020, the patient went to the emergency room where she received a computed tomography scan. The computed tomography scan of the lower abdomen showed that earlier diagnosis of diverticulitis 27 Nov 2020 ""inflammation"" had gotten better. Action taken with mRNA-1273 in response to the events were not reported. The outcome for events, severe leg cramps, severe diarrhea, nausea, abdominal pain, shaking chills, bloody diarrhea and hemorrhoid pain, were unknown.; Reporter's Comments: This case concerns a 62-year-old female patient with medical history of diverticulitis, who received their first of two planned doses of mRNA-1273 (Lot 011J20A), and who experienced the serious unlisted event of bloody diarrhea, the non-serious listed events of nausea and chills, and the non-serious unlisted events of severe leg cramps, severe diarrhea, abdominal pain, and hemorrhoid pain. Based on the current available information and temporal association between the use of the product and the onset of events after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. The patient's history of diverticulitis is noted.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,12/22/2020,0.0,UNK,,Diverticulitis,,,,"['Abdominal pain', 'Chills', 'Computerised tomogram abdomen abnormal', 'Diarrhoea', 'Diarrhoea haemorrhagic', 'Haemorrhoids', 'Muscle spasms', 'Nausea', 'Pain', 'Tremor']",1,MODERNA,OT 1004199,GA,,F,"possible stroke; face is drooping a little; had numbness and tingling on the left side of my face; had numbness and tingling on the left side of my face; red splotches about the size of a small leaf from injection site to elbow; had a rash opposite the injection site; a vein protruded out; bone chilling chills; deep pain in my arm that feel like someone was beating me; arm sore to touch; my arm was sore to touch from injection site to elbow; had a fever of 103 F/low grade (~99 F); I was shaking; blood pressure went up to 149/89; my heart rate was elevated to over 110; dull headache off and on since receiving the vaccine; A spontaneous report was received from a nurse who was also a 66-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced possible stroke, face is drooping a little, a vein protruded out, blood pressure went up to 149/89, my heart rate was elevated to over 110, deep pain in my arm that feel like someone was beating me; arm sore to touch; my arm was sore to touch from injection site to elbow, I was shaking, had numbness and tingling on the left side of my face, red splotches about the size of a small leaf from injection site to elbow, dull headache off and on since receiving the vaccine, had a rash opposite the injection site, my arm was sore to touch from injection site to elbow, bone chilling chills, and had a fever of 103 degrees Fahrenheit (F)/low grade (~99 F). The patient's medical history was not provided. There were no concomitant medications provided. On 08 Jan 2021 the patient received the first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly, in her right arm, for prophylaxis of COVID-19 infection. On 08 Jan 2021 at 3:00 pm, the patient received her first injection. Right after the injection, her blood pressure went up to 149/89 and her heart rate was elevated to over 110 and both came down to normal by 4 pm. A dull headache started on the same day. About midnight on 09 Jan 2021, the patient was awakened by deep vein in her arm that felt like someone was beating her. About 11 am the same day she had a fever of 103 degrees Fahrenheit, bone chilling chills., and she was shaking. Treatment included a hot shower, ibuprofen, paracetamol, and acetylsalicylic acid. The chills and shaking stopped after treatment. It was noted that fever lowered to about 99 degrees. On 11 Jan 2021, the patient had red splotches about the size of a small leaf and her arm was sore to touch from injection site to elbow. A vein protruded out and she had a rash opposite the injection site. On 12 Jan 2021, the fever had resolved. The patient noted that all right arm reaction lasted until Saturday, 16 Jan 2021. On 19 Jan 2021 in the evening, the patient had numbness on the left side of her face. It appeared as if her face was drooping a little, but there was nothing wrong with her smile or her speech. She noted she called the clinic and they wanted her to come in to determine if she had a possible stroke. Additionally, she reported she had a dull headache off and on since she got the vaccine. Action taken with mRNA-1273 in response to the event was not provided. The event of dull headache off and on since receiving the vaccine was not recovered/not resolved. The outcome for the events, possible stroke, face is drooping a little, had numbness and tingling on the left side of my face, was unknown. The outcome of the events, a vein protruded out, blood pressure went up to 149/89, my heart rate was elevated to over 110, deep pain in my arm that feel like someone was beating me; arm sore to touch; my arm was sore to touch from injection site to elbow, I was shaking, red splotches about the size of a small leaf from injection site to elbow, had a rash opposite the injection site, bone chilling chills, and had a fever of 103 F/low grade (~99 F) were resolved at the time of this report.; Reporter's Comments: This spontaneous report concerns a 66-years old female patient who experienced possible stroke, face is drooping a little, a vein protruded out, blood pressure went up to 149/89, my heart rate was elevated to over 110, deep pain in my arm that feel like someone was beating me; arm sore to touch; my arm was sore to touch from injection site to elbow, I was shaking, had numbness and tingling on the left side of my face, red splotches about the size of a small leaf from injection site to elbow, dull headache off and on since receiving the vaccine, had a rash opposite the injection site, my arm was sore to touch from injection site to elbow, bone chilling chills, and had a fever of 103 degrees Fahrenheit (F)/low grade (~99 F). The events of blood pressure went up, heart rate elevated and dull headache occurred on the same day after the administration of the first dose of mRNA-1273 ((lot number unknown) and events of deep vein in her arm that felt like someone was beating her, fever of 103 degrees Fahrenheit, bone chilling chills., shaking occurred 1 day after. The events of red splotches, arm was sore to touch from injection site to elbow, a vein protruded out, rash opposite the injection site developed 3 days after the vaccine dose and numbness on the left side of her face and possible stroke occurred 11 days after the vaccine dose. Treatment provided, fever and dull headache are resolved, and outcome of other events are unknown. He events of injection site redness and pain, fever, rash chills and headaches are consistent with the safety profile of the vaccine. Based on the current available information and temporal association between the use of the product and onset of the reported events a causal relationship cannot be excluded",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: no adverse event, Continue: [UNK], Comment: No reported medial history",,,"['Blood pressure increased', 'Chills', 'Facial paralysis', 'Headache', 'Heart rate increased', 'Hypoaesthesia', 'Injection site erythema', 'Injection site pain', 'Injection site reaction', 'Myalgia', 'Paraesthesia', 'Pyrexia', 'Rash macular', 'Sleep disorder', 'Tenderness', 'Tremor', 'Vein disorder']",1,MODERNA,OT 1004200,NY,28.0,F,"UTI; A spontaneous report was received from a 28 year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a urinary tract infection (UTI). The patient's medical history was not provided. No relevant concomitant medications were reported. On 21 Jan 2021, a day prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (batch number 02AL20A) intramuscularly in the left arm for COVID-19 infection prophylaxis. On 22 Jan 2021, the patient reported that she had experienced a UTI. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, UTI was unknown.; Reporter's Comments: This case concerns a 28 year-old female patient, who experienced a serious unexpected event of urinary tract infection. The event of urinary tract infection occurred 2 days after first dose of mRNA-1273, lot # 02AL20A. Treatment was not reported. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/22/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Urinary tract infection'],1,MODERNA,OT 1004201,ME,74.0,F,"Experienced symptoms of Benign Paroxysimal Postural Vertigo or BPPD; Malaise; Felt like mild flu; Swelling; Joint Pain; Fatigue; Feeling feverish; A spontaneous report was received from a consumer concerning a 74-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced joint pain, malaise, swelling, fatigue, felt like mild flu, feeling feverish and experienced symptoms of benign paroxysmal, postural vertigo or BPPD. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Acetaminophen, Losartan, Hydrochlorothiazide, and Trazadone. On 11 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 026I20A) intramuscularly in the right arm deltoid for prophylaxis of COVID-19 infection. On 14 Jan 2021, the patient experienced joint pain, malaise, swelling, fatigue, felt like mild flu, feeling feverish and experienced symptoms of benign paroxysimal, postural vertigo or BPPD. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events joint pain, malaise, swelling, fatigue, felt like mild flu, feeling feverish, and experienced symptoms of benign paroxysmal, postural vertigo or BPPD was not reported; Reporter's Comments: This spontaneous report concerns a 74-years-old, female patient who experienced joint pain, malaise, swelling, fatigue, felt like mild flu, feeling feverish and experienced symptoms of benign paroxysmal, postural vertigo or BPPD. The events occurred 3 days after the administration of the first dose of mRNA 1273 (lot number 026l20A, expiration date unknown). No treatment information was provided, and outcome is Unknown. Fever, fatigue and joint pain are consistent with the known safety profile of the mRNA-1273 vaccine and based on the current available information and temporal association between the use of the mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/14/2021,3.0,UNK,ACETAMINOPHEN; LOSARTAN; HYDROCHLOROTHIAZIDE; TRAZODONE,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Arthralgia', 'Fatigue', 'Influenza like illness', 'Malaise', 'Pyrexia', 'Swelling', 'Vertigo positional']",1,MODERNA,OT 1004202,PA,,F,"Presumed miscarriage; human chorionic gonadotropin decreased; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 31-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) who experienced vaccine exposure during pregnancy, human chorionic gonadotropin decreased and presumed miscarriage. The patient's medical history was not provided. The patient's prior history of pregnancies were two miscarriages (2013 and 2015) and two full term births (2017 and 2019) were reported. The patient's last menstrual period was 25 Nov 2021. The estimated due date was 1 Sep 2021. Concomitant medications included sertraline hydrochloride and vitamins. On 27 Dec 2020, the patient found out she was pregnant, but she already had some bleeding. On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On undisclosed date, after receiving the vaccine her human chorionic gonadotropin (hCG) levels went down to 0. Her health care professional presumed it was a miscarriage. Treatment for the event was not reported. On 19th Jan 2021, her hCG levels started to climb back up again. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, presumed miscarriage, and human chorionic gonadotropin decreased was unknown. The outcome of the event, vaccine exposure during pregnancy, was resolved on 28 Dec 2020.; Reporter's Comments: This spontaneous report concerns a 31-years-old, G5P2 female patient who experienced vaccine exposure during pregnancy and presumed miscarriage. The patient's last menstrual period was 25-Nov-2020 with estimated date of delivery as 01-Sep-2021. One day after the patient discovered she was pregnant; she received the first dose of mRNA-1273 vaccine (lot # 026L20A expiration date unknown). The event of presumed miscarriage (human chorionic gonadotropin (hCG) levels went down to 0) was diagnosed on an unknown date after vaccine administration. The HCG level began to climb up again 22 days after the vaccine administration. Based on the information provided which includes, the patient's obstetric history, vaginal bleeding the day prior to mRNA-1273 vaccination and without definitive confirmation of pregnancy loss, there is not enough evidence to assess that that there was a miscarriage and is also unlikely to be associated with mRNA-1273 administration. The event of vaccine exposure during pregnancy is considered not applicable",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,ZOLOFT; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS,,Medical History/Concurrent Conditions: Miscarriage; Term birth,,,"['Abortion spontaneous', 'Exposure during pregnancy', 'Human chorionic gonadotropin abnormal', 'Ultrasound scan', 'Vaginal haemorrhage']",1,MODERNA,OT 1004203,FL,71.0,F,"AFIB; A spontaneous report was received from a nurse concerning a 71-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced AFIB (Atrial fibrillation). The patient's medical history including COVID-19. Concomitant product use was not provided. On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient was hospitalized for two days with atrial fibrillation. The patient received Cardizem IV, converted back to sinus rhythm and discharged home two days later on Lopressor PO. Treatment for the event included Cardizem IV and Lopressor PO. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event AFIB was unknown.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of atrial fibrillation. This event occurred 1 days after first dose of mRNA-1273, lot # 013L20A. Treatment included Cardizem iv and Lopressor po. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/14/2021,01/15/2021,1.0,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,['Atrial fibrillation'],1,MODERNA,OT 1004204,NY,72.0,F,"Thrombocytopenia/lowplatelet; A spontaneous report was received from a caregiver concerning a 72-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced thrombocytopenia/low platelet count. The patient's medical history was not provided. No relevant concomitant medications were reported. On 18 Jan 2021 at 04:00 pm, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 19 Jan 2021, the patient was hospitalized for thrombocytopenia/low platelet count, the patient was in emergency room and was given a strong dose of steroid. Her body did not react to it and she was then given a platelet transfusion. The doctors have given her steroids, immunoglobulin and aminocaproic acid during the hospitalization. They were discussing the next steps of therapy and plan to try rituximab. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event thrombocytopenia/low platelet count was unknown.; Reporter's Comments: This case concerns a 72-year-old, female patient, who experienced a serious unexpected event of thrombocytopenia. This event occurred 2 days after first dose of mRNA-1273, lot # unknown. Treatment included steroids, platelet transfusion, immunoglobulin, Amicar and pending treatment with Rituximab. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.",Not Reported,,Yes,Yes,,Not Reported,U,01/18/2021,01/19/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Platelet count decreased', 'Platelet transfusion', 'Thrombocytopenia']",1,MODERNA,OT 1004205,NC,74.0,F,"Passed out-was totally out for a couple of second; UTI; PVCs; very very dizzy; Vasovagal reaction; Arm was sore-not hurting much; A spontaneous report was received from a 74-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced dizziness, passed out, vasovagal reaction, urinary tract infection, premature ventricular contractions and arm pain. The patient's medical history included back problems with osteoarthritis in the spinal column neck and lower back. Products known to have been used by the patient, within two weeks prior to the event, included celecoxib and nortriptyline. On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient reported she got very dizzy and passed out. Her husband relays that she was totally out for a couple of seconds. She went to the emergency room and was diagnosed with a vasovagal reaction and urinary tract infection. Premature ventricular contractions were also discovered and was not known prior to this event. Patient reports a normal blood pressure of 114-120/75. Patient also stated her arm was sore the day after vaccine but not hurting much during her usual four mile walk. Treatment for the event included intravenous medications in the emergency room, cephalexin, and a heart monitor. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events passed out, dizziness, vasovagal reaction and arm pain were resolved. The outcome of the events, urinary tract infection and premature ventricular contractions were unknown.; Reporter's Comments: This case concerns a 74 year-old, female patient, who experienced events of dizziness, passed out, vasovagal reaction, urinary tract infection, premature ventricular contractions and arm pain. The events occurred the next day after the first and last dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related. Further information have been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/21/2021,1.0,UNK,CELEBREX; NORTRIPTYLINE,"Osteoarthritis (on spinal column, neck and lower back and had lost 2 inches in height)",,,,"['Dizziness', 'Electrocardiogram ambulatory', 'Loss of consciousness', 'Pain in extremity', 'Presyncope', 'Urinary tract infection', 'Ventricular extrasystoles']",1,MODERNA,OT 1004206,MN,91.0,F,"Death; A spontaneous report was received from a nurse concerning a 91-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and died two days later. The patient's medical history included dementia. Concomitant medications reported included paracetamol. On 21 Jan 2021, approximately two days prior to her death, the patient received the first of two planned doses of mRNA-1273, intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient died. The nurse reporting the event stated that the patient's death was considered as due to ""natural causes"" and that she was not aware of any new-onset symptoms of illness prior to the patient's death. The patient was described as ""fragile"" and was under hospice care at the time of her death. An autopsy was not performed. Action taken with the drug in response to the event is not applicable. The patient died on 23 Jan 2021. The cause of death was natural cause of death related to dementia. Autopsy was not performed.; Reporter's Comments: This case concerns a 91-years-old female patient, with medical history of dementia, who experienced a serious unexpected event of death. This event occurred 2 days after first dose of mRNA-1273, lot # unknown. At the time of death, the subject was very fragile and was in hospice care. Concomitant medication included Tylenol. Treatment details were not provided. The doctor considered that the death was due to natural causes. However, autopsy was not performed. Very limited information regarding this event has been provided at this time. Based on the limited information available, it is difficult to assess a cause and effect relationship. The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Natural cause of death related to dementia",Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/23/2021,2.0,UNK,TYLENOL,,Medical History/Concurrent Conditions: No adverse event (No adverse event was reported.),,,['Death'],1,MODERNA,OT 1004207,CA,,F,"Anaphylactic reaction; Stomach hurt; Tired; Headache; Body ache; GI issues; Shortness of breath while talking; A spontaneous report was received from a 31-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction, stomach hurt, GI issues, shortness of breath while talking, fatigue, headache and body aches. The patient's medical history includes allergy to Tylenol, Imitrex, mango, pineapple, oranges, nuts, seafood and cinnamon. No relevant concomitant medications were reported. On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 21 Jan 2021, 5 minutes after receiving the vaccine, the patient experienced an anaphylactic reaction. She experienced shortness of breath, coughing, vomiting, pulse rate dropped to 40 and she showed signs of anaphylactic reactions. She was administered Benadryl 50 mg IM at the 5-minute mark and 1 dose of the EpiPen at the 20 minute mark. This helped relieve some of the tightness around the throat. She experienced a secondary anaphylactic reaction 5 hours later and was rushed to the emergency room. She was hospitalized from 21 Jan 2021 to 24 Jan 2021. While in the hospital, she experienced two more anaphylactic reactions reported as similar to the previous reactions except that for the last two reactions, she could feel them coming on before her coughing and tightness started. She states ""I felt very hot, clammy, and could feel the allergic reaction coming on for the last two reactions."" During the hospitalization, she was administered Benadryl, Solumedrol, and EpiPen. On 26 Jan 2021, she has recovered from her anaphylactic reaction but she was tired, has shortness of breath while talking, headache, body aches, her stomach hurts, and its hard for her to eat without having some GI issues. She has never felt like this before and it is very unusual for her. Action taken with the second dose of mRNA-1273 in response to the events were not reported. The outcome for the event, anaphylactic reaction was considered Resolved/Recovered On 26 Jan 2021. The outcome for the events, stomach hurt, GI issues,shortness of breath while talking, fatigue, headache and body aches was unknown.; Reporter's Comments: This case concerns a 31-year-old female patient with medical history of multiple food and drug allergies, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of anaphylactic reaction, the non-serious listed events of Fatigue, Headache, and Myalgia, and the non-serious unlisted events of stomach ache, gastrointestinal issues, and shortness of breath while talking. The event of anaphylactic reaction started within minutes after vaccination. Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/21/2021,01/21/2021,0.0,UNK,,Allergy to nuts; Drug allergy (Tylenol); Drug allergy (Imitrex); Fruit allergy (Pineapple); Fruit allergy (Oranges); Fruit allergy (Mango); Seafood allergy; Spice allergy (Cinnamon),,,,"['Abdominal discomfort', 'Abdominal pain upper', 'Anaphylactic reaction', 'Cold sweat', 'Cough', 'Dyspnoea', 'Fatigue', 'Feeding disorder', 'Feeling hot', 'Headache', 'Heart rate decreased', 'Myalgia', 'Pain', 'Throat tightness', 'Vomiting']",1,MODERNA,OT 1004208,TX,73.0,F,"Neuropathy in the finger / Neuropathy in the right arm; chills; Nausea; Headache; A spontaneous report received from a consumer concerning a 73-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced chills, nausea, headache, neuropathy in the finger and right arm. The patient's medical history was not provided. Concomitant medications reported included rosuvastatin and eye drop. On 16 Jan 2021, approximately 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number 041L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 16 Jan 2021, the patient experienced chills, nausea and headache, all of which resolved within 36 hours on 18 Jan 2021. She took 3 Tylenol, and a Zomig to help with the symptoms. On 24 Jan 2021, the patient began to experience neuropathy in her finger and right arm, which she reported as it was getting worse. Action taken with mRNA-1273 in response to the events was not reported. The events, chills, nausea and headache, were considered resolved on 18 Jan 2021. The outcomes of the events, neuropathy in the finger / neuropathy in the right arm were unknown.; Reporter's Comments: This spontaneous report concerns a 73-year-old female patient who experienced a serious event of neuropathy in the right finger and non-serious events of chills, nausea and headache. The events of chills, nausea and headache occurred on the same day after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: Unknown, expiration date-Unknown). Neuropathy occurred 8 days after the administration of mRNA-1273 vaccine. Treatment administered included Tylenol and Zomig for chills, nausea and headache with resolution. The events of chills, nausea and headache are consistent with the safety profile for mRNA-1273 vaccine. Based on the information provided, including temporal association and in the absence of any other etiology, a causal association cannot be excluded for all reported events. Causality for the event of neuropathy is also confounded by the patient's advanced age. Main field defaults to �possibly related'",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/16/2021,01/16/2021,0.0,UNK,ROSUVASTATIN; eye drop,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Chills', 'Headache', 'Nausea', 'Neuropathy peripheral']",1,MODERNA,OT 1004209,OK,79.0,F,"Stroke like symptoms; Couldn't speak; Shortness of breath; Legs and arm weakness; Dizziness with Nystagmus; Throat swelling; Dizziness with vertigo; Dizziness with vertigo; A spontaneous report was received from a nurse concerning a 79-year-old, white, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke like symptoms, dizziness with nystagmus, legs and arm weakness, couldn't speak, shortness of breath, throat swelling and dizziness with vertigo. The patient's medical history, as provided by the reporter included anemia, overactive bladder, fibroid cystic disease, allergy to fluoroquinolone, ciprofloxacin, povidone iodine, morphine and adhesive tape. The concomitant medications reported included atorvastatin, calcium, colecalciferol, metoprolol succinate, pramipexole hcl and prasugrel hcl for unspecified indications. On 07 Jan 2021, 11 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient experienced stroke like symptoms, couldn't speak, shortness of breath and throat swelling. It was reported that the patient was hospitalized for acute stroke. On an unknown date, while still being hospitalized, the patient developed, dizziness with nystagmus and dizziness with vertigo. The lab findings included, magnetic resonance imaging (MRI) and computed tomography (CT) scans as negative for acute findings, electrocardiography (EKG), complete blood count (CBC), X-ray and chemistries were reported as within normal limits. The patient remained hospitalized for 2.5 days while the symptoms improved. On 09 Jan 2021, the patient was discharged. On 20 Jan 2021, the reporter stated that the patient felt weak and tired without other symptoms. It was also noted that the patient's discharge summary stated the patient's symptoms may be worse following a second dose of mRNA-1273 vaccine. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, stroke like symptoms, dizziness with nystagmus, legs and arm weakness, couldn't speak, shortness of breath, throat swelling and dizziness with vertigo. were considered as resolved on an unknown date.; Reporter's Comments: This case concerns a 79-year-old, white, female patient with medical history of anemia, overactive bladder, fibroid cystic disease, who experienced the serious, unexpected event of stroke, Aphasia, dyspnea and non-serious, unexpected events of , dizziness, vertigo, pharyngeal swelling, nystagmus and muscular weakness. The events of stroke, Aphasia, Dyspnea and pharyngeal swelling occurred 11 hours after the first dose of mRNA-1273 (Lot number: 025J20-2A) administration and the events of dizziness, vertigo, pharyngeal swelling, nystagmus and muscular weakness occurred on an unknown date while the patient was still hospitalized. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/06/2021,01/07/2021,1.0,UNK,ATORVASTATIN; CALCIUM; VITAMIN D 3; METOPROLOL SUCCINATE; PRAMIPEXOLE HCL; PRASUGREL HCL,Adhesive tape allergy; Allergy to antibiotic; Drug allergy (Morphine); Iodine allergy; Overactive bladder; Uterine fibroid cyst,Medical History/Concurrent Conditions: Anemia,,,"['Aphasia', 'Cerebrovascular accident', 'Computerised tomogram normal', 'Dizziness', 'Dyspnoea', 'Electrocardiogram normal', 'Fatigue', 'Full blood count normal', 'Laboratory test normal', 'Magnetic resonance imaging normal', 'Muscular weakness', 'Neurological symptom', 'Nystagmus', 'Pharyngeal swelling', 'Vertigo', 'X-ray normal']",1,MODERNA,OT 1004210,,62.0,F,"Anaphylactic reaction; A spontaneous report was received from a 62-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction. The patient's medical history, as reported, included 4 previous anaphylactic reactions since she was 9 years old, history of throat problems and swelling, bronchitis, and her brother died in 1997 due to an anaphylactic reaction to poison ivy and bee stings. Concomitant medications reported included thyroid medication (not specified), blood pressure medication (not specified), gabapentin, sleep medicine (not specified) and curcuma longa rhizome. On 24 Jan 2021, about 15 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 24 Jan 2021, 30 minutes prior to receiving the vaccine, the patient took prednisone (dose unknown), per instructions from her doctor due to her history of anaphylactic reactions. She did notify the vaccinators of her history and there was an ambulance present. About 15 minutes after receiving the vaccine, the patient started coughing, had heavy chest pain, trouble breathing, and felt like her throat was constricting more than usual. No rash developed. She approached the ambulance and asked if she could take diphenhydramine. She took one dose, followed by 3 other doses, and felt a bit better. Consent given for Safety to follow up with patient. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, anaphylactic reaction was resolving at the time of this report.; Reporter's Comments: This case concerns a 62 year old female patient with medical history of included 4 previous anaphylactic reactions since she was 9 years old, history of throat problems and swelling, bronchitis, and her brother died in 1997 due to an anaphylactic reaction to poison ivy and bee stings. Concomitant medications reported included thyroid medication (not specified), blood pressure medication (not specified), gabapentin, sleep medicine (not specified) and curcuma longa rhizome. She experienced a serious unexpected event of Anaphylactic reaction that needed treatment diphenhydramine. The event occurred approximately 15 minutes after first dose of the study medication administration even thought the patient took prednisone prior to receiving the vaccine. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/24/2021,0.0,UNK,THYROID; GABAPENIN; TURMERIC [CURCUMA LONGA RHIZOME],,Medical History/Concurrent Conditions: Anaphylactic reaction (Past history of anaphylactic reactions that have occurred four times since she was 9 years old.); Anaphylactic reaction (Brother died in 1997 due to anaphylactic reaction to poison ivy and bee stings); Bronchitis (She used to get bronchitis 6 times a year before she started turmeric.); Throat swelling (History of throat problems and swelling.),,,"['Anaphylactic reaction', 'Chest discomfort', 'Chest pain', 'Cough', 'Dyspnoea', 'Throat tightness']",1,MODERNA,OT 1004211,TN,76.0,F,"Afib; Feeling uncomfortable; Blood sugar was around 150, which is higher than her normal levels; A spontaneous report was received from a consumer who is 76-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced atrial fibrillation, feeling uncomfortable, and increased blood sugar. The patient's medical history included diabetes and atrial fibrillation. Concomitant medications were not reported. On 02 Jan 2021, the patient received their first two planned doses of mRNA-1273 (Batch number: 025LZ0A) intramuscularly in her right arm for the prophylaxis of COVID-19 infection. On 02 Jan 2021, the patient experienced heart beating very fast and feeling uncomfortable; it lasted for a few hours. She stated it was atrial fibrillation, she had a diagnosis of this, and it only lasted a few hours. The patient also stated that her blood glucose was 150, which was higher than normal. Treatment for the events was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, increased blood sugar, was considered not resolved. The outcome of the events, atrial fibrillation and feeling uncomfortable, was considered resolved.; Reporter's Comments: This case concerns a 76 year-old female patient with a significant medical history of atrial fibrillation and diabetes, who experienced a serious unexpected event of Atrial fibrillation and non-serious unexpected events of Discomfort and Blood glucose increased. The events occurred one day (same day) after first dose of mRNA-1273, lot # 025LZ0A. Treatment was not reported. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. However, patient's medical history of atrial fibrillation and diabetes were considered strong confounders.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,UNK,,Atrial fibrillation; Diabetes,,,,"['Atrial fibrillation', 'Blood glucose increased', 'Condition aggravated', 'Feeling abnormal', 'Heart rate increased']",1,MODERNA,OT 1004276,GA,74.0,M,"patient received first dose on 14Jan2021 and tested positive for COVID-19 on 20Jan2021; patient received first dose on 14Jan2021 and tested positive for COVID-19 on 20Jan2021; Sore Arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), intramuscular on 14Jan2021 at a single dose on left arm for COVID-19 immunization. Medical history included heart disease (unspecified). The patient is taking a lot of medication (unspecified). The patient had no prior vaccinations within 4 weeks. He tested positive yesterday, 20Jan2021, for COVID-19. His question was if he should get the second shot. The patient stated he had a sore arm on 14Jan2021, but really had no adverse reactions. The patient underwent COVID-19 rapid test: positive on 20Jan2021. The patient recovered from sore arm on 15Jan2021. Outcome of event ""tested positive for COVID-19"" was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,PVT,,,"Medical History/Concurrent Conditions: Heart disease, unspecified",,,"['COVID-19', 'Pain in extremity', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 1004302,MN,60.0,F,"admitted to hospital with platelet count of 8,000; petechiae; This is a spontaneous report from a contactable physician. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) via Intramuscular on 18Jan2021 into left arm at a single dose for covid-19 immunization. Medical history included hypothyroidism and neomycin allergies. The patient did not get covid prior vaccination. Concomitant medications included calcium, levothyroxine sodium (SYNTHROID), trazodone, tocopherol (VIT E) and no other vaccine in four weeks. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9261) via Intramuscular on 28Dec2020 into left arm at a single dose for covid-19 immunization. 24 hours after injection she developed petechiae and was admitted to hospital with platelet count of 8,000 on 20Jan2021 22:00, the patient has ITP with baseline platelet count of 60,000. All events lead to hospitalization for 5 days (PENDING CLARIFICATION) and received IgG and oral Dexamethas as treatment. On 20Jan2021, the patient did Sars Co V 2 RNA test via Nasal Swab and result negative. The outcome of the events was recovering.; Sender's Comments: Based on a close chronological association, a causal relationship between events petechiae and thrombocytopenia and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/18/2021,01/19/2021,1.0,PVT,CALCIUM; SYNTHROID; TRAZODONE; VIT E [TOCOPHEROL],,Medical History/Concurrent Conditions: Hypothyroidism,,,"['Immune thrombocytopenia', 'Petechiae', 'Platelet count decreased', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,OT 1004319,MA,49.0,M,"oxygen dropping to 89; causing me to have breathing problems; heavy breathing when I walked and wore the mask; sensitivity to the cold; had instances where I felt an unusually high chill on my chest and wavy feeling; fever rising as high as 100.4; had instances where I felt an unusually high chill on my chest and wavy feeling; was told that I looked red; Had soreness on site the night of the injection; headaches; tiredness; This is a spontaneous report from a contactable contactable consumer (patient) . A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at left arm on 14Jan2021 14:30 at SINGLE DOSE for COVID-19 immunization.Medical history included Type one diabetes, obesity, high cholesterol.No COVID prior vaccination . Facility where the most recent COVID-19 vaccine was other .The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. No Concomitant medications reported.Clincal course was reported as follows: on 14Jan2021 I had soreness on site the night of the injection, had headaches, tiredness, and was told that I looked red and was not myself beginning on the next day. I have had sensitivity to the cold, which I never had before, and heavy breathing when I walked and wore the mask. I had instances where I felt an unusually high chill on my chest and wavy feeling, causing me to have breathing problems. I have had fever rising as high as 100.4, and oxygen dropping to 89. The events were reported as non-serious. The patient went to Emergency room/department or urgent care and was treated with Prednisone, inhaler and Tylenol.The patient had been tested for COVID post vaccination (Nasal Swab(20Jan2021) :unkonwn results).Outcome of the events was recovering. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Diabetes; High cholesterol; Obesity,,,"['Abnormal behaviour', 'Chills', 'Dyspnoea', 'Erythema', 'Fatigue', 'Feeling abnormal', 'Headache', 'Hypersensitivity', 'Injection site pain', 'Oxygen saturation decreased', 'Pyrexia', 'SARS-CoV-2 test', 'Temperature intolerance']",UNK,PFIZER\BIONTECH, 1004332,AL,,M,"Covid test positive; Covid test positive; feeling bad/even worse; feel like sick; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumers (one of which is the patient) reported that a male patient of an unspecified age (reported as 45, no unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date then received the second dose on 19Jan2021 both via an unspecified route of administration at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient's second shot was on Tuesday (19Jan2021). He was feeling really bad Tuesday afternoon, and on Wednesday (20Jan2021) even worse. He worked in a laboratory. He took a COVID test Wednesday at work, and within two minutes of testing himself it said positive. They also have PCR test. He was wondering if the vaccination can cause false positives. He feel like he's sick, like there was something going on. The patient wasn't hospitalized. He was already sitting at home in quarantine. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/01/2021,,OTH,,,,,,"['COVID-19', 'Feeling abnormal', 'Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1004358,MD,52.0,F,"throat was getting somewhat tight, some swelling; throat was getting somewhat tight, some swelling; slightly lightheaded; mild headache; This is a spontaneous report from a contactable other health professional (patient). A 52-year-old female patient received first dose of BNT162B2 (lot no. and expiry date were not reported), via an unspecified route of administration into left arm on 20Jan2021 13:30 at single dose for Covid-19 immunization. The patient is not pregnant. Medical history included allergies to shrimp and lobster, mild asthma and high blood pressure. Concomitant medication included diltiazem, benzoyl peroxide (BP), cetirizine hydrochloride (ZYRTEC), loratadine, paracetamol (TYLENOL) and vitamins. The patient had allergies to past blood pressure medications which included amlodipine besilate (NORVASC), irbesartan (AVAPRO) and lisinopril. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. After taking first dose about 20 minutes on 20Jan2021 at 13:50 the patient felt slightly lightheaded and had mild headache, no real concern. Left observation area to go home after 45 minutes. No other symptoms at that point. Light headedness went away. While driving and running errands a few hours later the patient noticed her throat was getting somewhat tight, some swelling on 20Jan2021 at 16:30; this is similar to when she used to have shrimp/lobster allergic reactions. The patient took 1 tab of Benadryl before it got too bad and it subsided after about 30 min. No shortness of breath or any more symptoms so she went home and went to sleep after a few hours. She woke up and her throat had still some swelling. She called her doctor and she was recommended to take more allergy meds throught out the day and to report event to facility and to monitor. The swelling has not gone but much better. She was concerned about 2nd shot if it can be given where she was observed and monitored for a day. The patient recovered from slightly lightheaded on unspecified date. The outcome of headache was unknown and the remaining events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events throat tightness and throat swelling are possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,WRK,DILTIAZEM; BP; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LORATADINE; TYLENOL,,Medical History/Concurrent Conditions: Asthma; Blood pressure high; Shellfish allergy,,,"['Dizziness', 'Headache', 'Pharyngeal swelling', 'Throat tightness']",1,PFIZER\BIONTECH, 1004368,,,M,"muscle spasms from his lower back to his toes on the right side; sciatica; pain; This is Spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is a first of second reports. This consumer reported for a male patient (Husband, Age: 71) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unknown route of administation on 12Jan2021 at single dose on Arm Left for covid-19 immunisation. Medical history and concomitant medications were unknown. The consumer wanted to report an AE to the first dose of the covid 19 vaccine. The consumer states her husband experienced a twinge in his ham string 2 days before the vaccine but continues to play (caller motioned her husband is athletic) . Husband received the first dose of the vaccine on 12Jan2021, played on the 13th and could not play on the 14th two days after vaccine he experienced muscle spasms from his lower back to his toes on the right side and could not get out of bed.( shot was in the left arm) Husband went to the hospital on the 16th and they discharged him and he went back on the 17th and did a mri and diagnosed with sciatica and gave him oxycodone 10mg 1 mg 1 four times a day as needed, cyclobenzaprine 10 mg 1 every 8 hours, and gabapentin 100 mg 2 three times a day and a prednisone 6 pack. Reported not getting any better so took him to pain management and ride over there was hell, could not get comfortable and screamed the whole way over which was 20 minute ride and went in the office in a wheelchair. They gave him a steroid and told him to wait 1/2 hour. When leaving he experienced the worst spasm ever and they gave him toradol and then additional steroid injections. Husband was able to walk out with a walker. The consumer can only lay down, can not sit up and is bedridden. Spasms have stopped at the time of the phone call but still in pain. Having PT come for consult. Husband insists on getting second dose and caller asked agent ""what do I think?"". Husband was told at the hospital that another patient his age came in with the same symptoms as his after a dose of the covid 19 vaccine. The consumer stated her husband insisted on getting the second dose of the covid 19 vaccine and asked the agent ""what do I think?"". The outcome of the event muscle spasms from his lower back to his toes on the right side was recovering. The outcome of the other events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021078548 same reporter/drug/event, different patient",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/12/2021,,,UNK,,,,,,"['Magnetic resonance imaging abnormal', 'Mobility decreased', 'Muscle spasms', 'Pain', 'Sciatica', 'Screaming']",1,PFIZER\BIONTECH, 1004369,MD,36.0,F,"hives started to appear on her body/hives on her neck; nauseous/ was going to throw up; dizzy; difficulty breathing (wheezing); difficulty breathing (wheezing); injection site soreness; She was hot, flush; difficulty swallowing; the tongue started swelling/Swollen tongue; Anaphylactic reaction/anaphylaxis; This is a spontaneous report from a contactable consumer reported for self. This 36-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Jan2021 12:52 left arm at single dose (Lot: EL3247) for covid-19 immunisation. Medical history included ongoing Anaphylaxis to Walnuts, Oranges, and morphine, ongoing allergy to a steroid cream Kenalog, and a steroid powder which she broke out immediately and ongoing Colitis. Concomitant therapy was none. She received the first dose of the vaccine yesterday on 20Jan2021 12:52 and 10 minutes later (20Jan2021 13:02) the tongue started swelling/Swollen tongue so they gave her Benadryl to try to stop it but it didn't help enough, hives started to appear on her body so they gave her a dose of epinephrine in the right arm and put on an IV, because she was feeling nauseous and dizzy. She started to feel better and was transferred to the hospital, when she was in the hall of the hospital she started having difficulty breathing (wheezing) and difficulty swallowing so she received another dose of Epinephrine (EpiPen) and also Benadryl, Prednisone and Pepcid. She went home and was taking Prednisone (1 daily), Benadryl and salbutamol (twice daily). She went into anaphylaxis within 15 minutes of receiving it on 20Jan2021. She brought 2 Epi injections with her. They monitored at the hospital for a few hours. She knows exactly how it happened. She was sitting in the observation room. She had told them multiple times that she had allergies before. She came in with two Epi pens and Benadryl. She let them know that as well. She was very verbal that she has history of anaphylaxis. They gave it to her. They said they were going to monitor her for 30 minutes. Her tongue started to swell 10 minutes after. She was sent to the paramedic tent. She took liquid children's Benadryl to try to stop the reaction. It did not help. She clarified it just didn't work enough to delay it. She doesn't have UPC, but provided the following information from the bottle: PLD-H242C LB004314 Lot WJ00896 Expiration Feb2023. She then started getting hives on her neck. She was hot, flush, and dizzy. She felt like she was going to throw up. That passed. They then gave her Epi in the opposite arm, her right arm. She got the COVID vaccine in her left arm. Then, they got her ready to go to the hospital. The transfer was smooth. She was waiting for intake when she started to not be able to swallow. She complained quickly. The nurses ran to get Epi, but the paramedic grabbed the patient's Epi pen and injected it in her thigh. She was IVed up at the vaccine center before transfer. They gave her Benadryl, Pepcid, and methyl prednisone. The Epi pen they gave her was her own shot. They monitored her a few hours. Then sent her home with Pepcid, more Epi pens, and Prednisone for 4 days. She has had normal soreness in her arm at the injection site. It has been status quo, it feels like a tetanus shot. She still has swelling in tongue, but they told her that might take a day or two to go away. She is supposed to also take Benadryl for the next 2 days. She was given the vaccine at the (Place name). Events visit to Emergency Room. They did a CBC and she was in normal range for everything. Lab data included on 20Jan2021: CBC normal. Outcome of the event Swollen tongue was recovering. Outcome of the event Anaphylactic reaction/anaphylaxis was recovered. Outcome of the event injection site soreness was not recovered. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,UNK,,"Anaphylaxis (to Walnuts, Oranges, and morphine); Colitis (Verbatim: Colitis)",,,,"['Anaphylactic reaction', 'Dizziness', 'Dysphagia', 'Dyspnoea', 'Feeling hot', 'Flushing', 'Full blood count normal', 'Injection site pain', 'Nausea', 'Swollen tongue', 'Urticaria', 'Wheezing']",1,PFIZER\BIONTECH, 1004370,TX,90.0,F,"trouble breathing/couldn't breathe without oxygen; possible COVID-19 pneumonia; possible COVID-19 pneumonia; wouldn't eat; incoherent; thrashing around with her legs, would not settle down/legs were thrashing around; persistent UTI; aspiration pneumonia; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for the mother. A 90-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech) (lot# EL3249), intramuscular in right upper arm, on 14Jan2021 between 12:00 PM to 12:30 PM , at single dose, for COVID-19 immunisation. She was monitored for an hour after vaccine. Medical history included penicillin allergy, ongoing vascular dementia, cardiac pacemaker insertion, congestive heart failure. There were no concomitant medications. The patient previously took ciprofloxacin and experienced drug hypersensitivity and rash (she took the prescribed dose and immediately broke out after, all over her body), codeine and experienced drug hypersensitivity, neomycin and experienced drug hypersensitivity, neosporine and experienced drug hypersensitivity. The patient experienced aspiration pneumonia in Jan2021 with outcome of unknown, wouldn't eat on 17Jan2021 with outcome of unknown, trouble breathing/couldn't breathe without oxygen on 21Jan2021 with outcome of unknown, incoherent on 15Jan2021 with outcome of unknown, thrashing around with her legs, would not settle down/legs were thrashing around on 15Jan2021 with outcome of unknown, persistent urinary tract infection (UTI) on an unspecified date in Jan2021 with outcome of unknown. The events were considered serious as caused patient's hospitalization. Clinical course: on 15Jan2021 night the patient started thrashing around with her legs, would not settle down, she was incoherent. On 17Jan2021, when she woke up, she was completely incoherent and would not eat. On 17Jan2021 she was taken to the emergency room (ER), and was diagnosed with aspiration pneumonia and persistent urinary tract infection (UTI). The patient was admitted on 17Jan2021 and she was treated. On 18Jan2021 patient got better, they put her on a bunch of antibiotics. On 19Jan2021 patient walked the halls, she wasn't incoherent. She was going to get PT/OT, speech therapy. The patient was discharged on 20Jan2021 and was taken to rehab type place (near the hospital), she was fine. However over the night she got worse. She became incoherent again and couldn't breathe without oxygen (21Jan2021). On 21Jan2021 the patient was sent back to ER due to trouble breathing. The reporter stated that something happened at nursing home and the patient went bonkers. She was admitted again (still ongoing) and put to intensive care unit (ICU) for treatment. The patient underwent lab tests and procedures which included cardiac function test: nothing wrong with heart in Jan2021, chest x-ray: concerning for possible Covid pneumonia on 17Jan2021 (transvenous pacemaker is present some peripheral, increased entity present Concerning for possible COVID pneumonia), CT scan: no evidence of pleural effusion or pneumothorax in Jan2021, COVID-19 virus test: negative in Jan2021 (2 times during the ER trips). Therapeutic measures were taken as a result of the events and included treatment with unspecified antibiotics.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/14/2021,01/01/2021,,PVT,,Vascular dementia,Medical History/Concurrent Conditions: Cardiac pacemaker insertion; Congestive heart failure; Penicillin allergy,,,"['Abnormal behaviour', 'Cardiac function test normal', 'Chest X-ray abnormal', 'Computerised tomogram normal', 'Dyskinesia', 'Dyspnoea', 'Food refusal', 'Incoherent', 'Intensive care', 'Pneumonia aspiration', 'SARS-CoV-2 test negative', 'Urinary tract infection']",1,PFIZER\BIONTECH,OT 1004371,NC,77.0,F,"she did not feel totally right; some high blood pressure; she has an irregular heart beat; This is a spontaneous report from a contactable consumer (patient). The 77-years-old female patient received first dose of BNT162b2 (BNT162B2, lot number: EL3248), via an unspecified route of administration on 18Jan2021at SINGLE DOSE for covid-19 immunisation. Medical history included diagnosis of irregular heart rate prior to the vaccine, about 4-5 years ago, allergy, Cholesterol. The patient experienced some high blood pressure on Jan2021, she has an irregular heart beat on Jan2021. ""I developed some high blood pressure after getting the vaccine."" she has developed a very high blood pressure reading and that is unusual for her, states she went to a walk in clinic on Tuesday and then to the doctor today. Caller states that it really concerns her that someone who is medically savvy as she could have a serious problem. stated that she did not feel totally right while she was waiting afterwards, states that she came home and laid around and the next morning, she can tell when it is high because she is chronically low. Caller states the next morning the top number of her blood pressure was 166, states bottom number is never out of sync (AS REPORTED). Caller states she could feel it really bad yesterday, really bad states she took the pressure once and it was 182/94 and a little later it was 192/84 and that is when she went to the walk in clinic. Caller states she has an irregular heart beat and she takes a blood pressure medication to treat that, takes 25mg once a day at night time. Yesterday morning she took another one before she went to the walk in clinic to help treat the high blood pressure, so she had 50 mg in 12 hours; when she got there they checked it and it was 178/72. She also takes an allergy medication and something for cholesterol that she has been taking for years. She called on 21Jan2021 around 5pm regarding the Pfizer covid vaccine. She called because she was having blood pressure issues and two different doctors thought it was covid vaccine related. It has taken since then till today to get a reasonable blood pressure. Her thoughts are not to get the second dose. She is asking if she will have any protection if she does not get the vaccine and if there will be any adverse effects if she goes not get the second vaccine. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,01/01/2021,,UNK,,,"Medical History/Concurrent Conditions: Allergy; Blood cholesterol abnormal; Heart rate irregular (Diagnosed with irregular heart rate prior to the vaccine, about 4-5 years ago.)",,,"['Feeling abnormal', 'Heart rate irregular', 'Hypertension']",1,PFIZER\BIONTECH, 1004375,NM,38.0,F,"feeling some increasing shortness of breath; feeling some increasing shortness of breath; scratchy throat; some swelling in her bilateral periorbital area; have a mild headache; This is a spontaneous report from a contactable Pharmacist. A 38-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, lot # EL3302) intramuscular at single dose at right arm on 14Jan2021 11:30 for Covid-19 immunisation, administered at hospital. Medical history included, chronic headaches and vertigo, depression, type 2 diabetes mellitus (DMT2), hypertension, vitamin d deficiency, sleep apnoea syndrome (OSA), chronic pain, psoriatic arthropathy, allergies: ACE inhibtors, gabapentin, lisinopril, Lyrica, milk products, nuts. Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included: amlodipine (manufacturer unknown) 2.5mg, apremilast (manufacturer unknown), bupropion (manufacturer unknown) 150mg bid, calcipotriene (manufacturer unknown) topical, carvedilol (manufacturer unknown) 12.5mg bid, ergocalciferol (VIT D, manufacturer unknown) 1000 units, duloxetine (manufacturer unknown) 20mg bid, dicyclomine (manufacturer unknown) 20mg qid, losartan (manufacturer unknown) 50mg qday. The patient previously received the 1st dose of bnt162b2 (BNT162B2, lot # EL1284) intramuscular at single dose at left arm on 23Dec2020 12:30 PM for Covid-19 immunisation, administered at hospital. Patient denied any allergic reaction to the initial dose of Covid vaccine. No other vaccine has been received in 4 weeks. On 14Jan2021 12:00 PM after vaccination, she has being monitored for the mandatory 15-30 minute period, when she started feeling some increasing shortness of breath, scratchy throat, some swelling in her bilateral periorbital area. She was then taken to the ED for further evaluation. Patient denied any allergic reaction to the initial Covid vaccine 3 weeks before. She denied any abdominal pain, diarrhea, nausea, vomiting, chest pain, shortness of breath. She had a mild headache. In ED, patient received treatment with diphenhydramine 25mg IV, epinephrine 0.3mg IM, famotidine 20mg IV and dexamethasone 10mg IV, and LR 1,000mL bolus @ 1228, ketorolac 15mg @1312, ondansetron 4mg @1312. Patient monitored and discharged at 1530. Post vaccination, the patient has been tested with nasal swab for COVID-19 and resulted negative on 15Jan2021. Therapeutic measures were taken as a result of events. The outcome of recovered in Jan2021.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,PVT,AMLODIPINE; APREMILAST; BUPROPION; CALCIPOTRIENE; CARVEDILOL; VIT D; DULOXETINE; DICYCLOMINE; LOSARTAN,,Medical History/Concurrent Conditions: Allergy to nuts; Chronic headaches (chronic); Chronic pain; Depression; Drug allergy; Hypertension; Hypovitaminosis D; Milk allergy; Obstructive sleep apnea syndrome; Psoriatic arthritis; Type 2 diabetes mellitus; Vertigo (chronic),,,"['Dyspnoea', 'Headache', 'Periorbital swelling', 'SARS-CoV-2 test negative', 'Throat irritation']",2,PFIZER\BIONTECH,OT 1004380,GA,48.0,F,"it looks and sounds like she has Bell palsy; mental fog; Nauseated; left side of face numb; left tongue felt numb and fat as though I got injected at the dentist; Then medicine taste in my mouth and some slurring; Then medicine taste in my mouth and some slurring; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old female patient received first dose of BNT162B2 (Lot number and expiry date not available), via an unspecified route of administration on 21Jan2021 10:45 at single dose in the left arm for COVID-19 immunization. Medical history included Hypo thyroid (medication not needed at this time). The patient had no known allergies. Concomitant medication included cefixime (FLEXERIL) and ibuprofen (IBU). On 21Jan2021 11:00, after 15 minutes of getting the vaccine, the patient felt nauseated. Then it continued to get worse from there left side of face numb, mental fog, left tongue felt numb and fat as though she got injected at the dentist. Then medicine taste in her mouth and some slurring. Stated that her boss which is doctor side it looks and sounds like she has Bell palsy. She was prescribed Methylprednisolone and she feel somewhat better. Still waiting to feel completely myself. It's been now about 8 hours since her vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all the events which included methylprednisolone. The outcome of the events was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 to the onset of reported events Bell palsy and mental fog occurred 15 minutes after getting the vaccine cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,UNK,FLEXERIL [CEFIXIME]; IBU,,Medical History/Concurrent Conditions: Hypothyroidism (other medical history: Hypo thyroid (medication not needed at this time)),,,"['Dysarthria', 'Dysgeusia', 'Facial paralysis', 'Feeling abnormal', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Nausea', 'Swollen tongue']",1,PFIZER\BIONTECH, 1004384,KY,41.0,F,"Had covid after 19 days got the vaccine; Had covid after 19 days got the vaccine; immediately lightheaded dizzy; body aches; severe sore throat; gums swollen and red; gums swollen and red; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 15Jan2021 15:15 at single dose for COVID-19 immunisation. Medical history included covid-19 (covid prior vaccination: Yes). No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID). No other vaccine in four weeks. The patient experienced side effects immediately lightheaded dizzy , body aches, severe sore throat, gums swollen and red on 15Jan2021, had covid after 19 days (as reported) got the vaccine. The events resulted in emergency room/department or urgent care. Events treatment included steroids and fluids. The outcome of events was not recovered. No covid tested post vaccination. The patient was not pregnant. Information about Lot/Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported covid based on the known safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,PVT,SYNTHROID,,Medical History/Concurrent Conditions: COVID-19 (If covid prior vaccination: Yes),,,"['COVID-19', 'Dizziness', 'Gingival erythema', 'Gingival swelling', 'Immediate post-injection reaction', 'Oropharyngeal pain', 'Pain']",1,PFIZER\BIONTECH, 1004386,NM,37.0,M,"Acute hemolytic anemia; Felt pale and tachycardic; Felt pale and tachycardic; This is a spontaneous report from a contactable pharmacist. A 37-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), intramuscularly on 06Jan2021 12:30 on Left arm at single dose for COVID-19 immunization, facility where the most recent COVID-19 vaccine was administered in Hospital; pembrolizumab (KEYTRUDA), via unspecified route of administration from 01Dec2020 and from 22Dec2020 at unspecified dosage for unspecified indication. Medical history included thymic carcinoma stage IV, Allergy to adhesive tape. Concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (lot number=EJ1685) intramuscularly on 18Dec2020 14:15 on Left arm for COVID-19 immunization. It was reported that patient was receiving Keytruda (01Dec2020 and 22Dec2020) which could cause hemolytic anemia. Labs were stable on 22Dec2020. Patient felt pale and tachycardic the next day (07Jan2021) but didn't notify us. He had follow-up on 1/12/2021 at the cancer center. The labs were consistent with acute hemolytic anemia (12Jan2021 at 08:00 AM), and patient was closely followed by hematology. He was on immunotherapy for cancer treatment, but there was concern for COVID vaccine contributing the hemolytic anemia. Events were result in doctor or other healthcare professional office/clinic visit. Treatment received for acute hemolytic anemia included blood transfusion. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The action taken for pembrolizumab was unknown. The outcome of the events were not resolved.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events acute hemolytic anemia, pallor and tachycardia cannot be completely excluded. concomitant use of KEYTRUDA and patient's underlying medical condition may have also contributed to reported events. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/01/2020,01/07/2021,37.0,PVT,KEYTRUDA,,Medical History/Concurrent Conditions: Adhesive tape allergy; Malignant neoplasm of thymus,,,"['Haemolytic anaemia', 'Inappropriate schedule of product administration', 'Laboratory test abnormal', 'Pallor', 'Tachycardia', 'Transfusion']",2,PFIZER\BIONTECH,OT 1004387,LA,70.0,F,"I was sneezing non stop; injection site was sore; can't taste; nose started running/ my nose was like a faucet, non stop, clear; asked if it can it give her COVID since her symptoms were similar to COVID; asked if it can it give her COVID since her symptoms were similar to COVID; I felt scratchy in my throat; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248 and expiration date not provided), via an unspecified route of administration in the left arm on 13Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took shingles vaccine for immunization and experienced shingles. The patient reported that she got her first dose of the COVID vaccine on 13Jan2021. On 17Jan2021 night and into 18Jan2021, she felt scratchy in her throat. She did not think anything of it because the temperature change was not unusual in the patient's state and so she thought it was that. But, on 19Jan2021, her throat was more scratchy and then her nose started running more. By Wednesday, 20Jan2021, her nose was like a faucet, non stop, clear and her throat was definitely scratchy and she was sneezing non stop. Her injection site was sore too which she totally expected. Now, her physician has given her a steroid pack and did a rapid test, which was negative but the following day they are doing a PCR test, so, she will see. She also stated that she can still smell but can't taste and that started last night, 20Jan2021. She asked if they were seeing these. And if this was listed or being reported and if she should get the second dose. She went on to state that ""I would not call my symptoms severe and I'm having my PCR tomorrow, but when they mention to me that they have had other patients with this experience"". She also asked if it can it give her COVID since her symptoms were similar to COVID and other people are having symptoms. She also reported that 4 months ago, she got her first shingles vaccination and ""it knocked me on my butt, I still haven't got the second injection but I got shingles"" and asked should she have gotten the COVID vaccine if she just got over shingles 3-4 weeks ago. She reported that she got her first dose of the COVID vaccine on 13Jan2021 and her second dose is scheduled for 30Jan2021 (17days apart). She did not have a question about the timing of the vaccine, only mentioned when her second dose was due and the it was 17 days after the first. She wanted to know if Pfizer was seeing a lot of this, and it could this her body reacting to the vaccine. She wanted to know what she should do with the second vaccine, if she should get it. She works at a school and has been making sure to wash her hands and everything. The outcome of the events Rhinorrhoea, and Vaccination site pain was unknown. The outcome of the event ageusia was not recovered while the outcome of the rest of the events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082498 same drug/event, different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/17/2021,4.0,UNK,,,,,,"['Ageusia', 'Injection site pain', 'Rhinorrhoea', 'SARS-CoV-2 test negative', 'Sneezing', 'Throat irritation']",1,PFIZER\BIONTECH, 1004391,TN,38.0,F,"face started itching; throat was getting dry; face was starting too itch and be red; hives after second dose of vaccine; This is a spontaneous report from a contactable Other HCP reported for herself. This 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EL1283, Expiry Date: 30Apr2021), via an unspecified route of administration on 18Jan2021 06:45 at single dose injected into left arm for COVID-19 immunisation. Medical history included asthma from 2010. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT EJ1685, EXP 31Mar2021.) on 18Jan2021 at 04:00PM, injected into her right arm for COVID-19 immunisation, uses salbutamol (ALBUTEROL, NDC: 6699301968, LOT: VE7L, EXP: Nov2021) inhaler as needed for asthma and took inhaled steroids, but nothing recent. The patient got the second dose of the vaccine at 06:45AM, and the hives began on the 21Jan2021, she noticed them about 06:20AM and she had to be at work at 07:00AM. She said she treated that with diphenhydramine hydrochloride (BENADRYL, 25mg LOT: P120108. EXP May2022, UPC: 193968051518) because her face started itching and her throat was getting dry, so she took BENADRYL 25mg this morning about 06:40AM. She says she took one dose of this by mouth, because it seems to make her sleepy and she had to work. She says she got to work and started working, and her face was starting too itch and be red, and her throat was super dry, this was at 07:20AM, so she took prednisone (NDC: 20603-5338-31, LOT 8675217, EXP Dec2020) 60mg by mouth. She says this was expired, but she still took it, it is in a dose pack that has a box that says distributed by (Company name). She says she took Prednisone 60mg, one time today by mouth. She says she has asthma so she keeps a prescription of Prednisone at home that her doctor writes so she can have it, she says with asthma she keeps Prednisone around. She says she also applied equate Hydrocortisone cream 1% (LOT: 0JT0306, EXP Aug2022) that she got over the counter to the hives topically. She says that the label for that says underneath anti-itch it says intensive healing that it is mixed with vitamins, chamomile and Vitamins A, C, and E. Equate Hydrocortisone cream 1% UPC: Unknown, the tube has a barcode with no number, it did have a box that she did throw away. She thought hives was medically significant, but it is not getting worse, it is worrisome, but she is improving with the medicine she used for treatment. The outcome of hives was recovering. The outcome of other events was unknown.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/21/2021,3.0,UNK,,,Medical History/Concurrent Conditions: Asthma,,,"['Dry throat', 'Erythema', 'Pruritus', 'Somnolence', 'Urticaria']",2,PFIZER\BIONTECH, 1004402,TX,58.0,M,"extreme chills; awful headache; body aches; severe sweating; low oxygen; 102 degree temperature; 120 pulse rate(abnormal for me); my arm felt like it was broken (9/10), but no other problems. Twelve hours later, the pain was still 9/10"".; shoulder still sore; This is a spontaneous report from a contactable 58-year-old female consumer reporting for herself A 58 years old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249) on 16Jan2021 at 23:30 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. The patient did not have medical history. Concomitant medications were not reported. The patient reported at inoculation, the injection was high on right arm, and his arm felt like it was broken (9/10), but no other problems. On 17Jan2021 twelve hours later, the pain was still 9/10 so the patient put two heating pads on the site of injection. On the same day (17Jan2021) shortly thereafter, patient also experienced extreme chills, low oxygen (94), 102 degree temperature, 120 pulse rate (abnormal for him), awful headache, body aches, then severe sweating. This peaked 8 hours later and it was gone within 24 hours. No Treatment was given for the events. At the time of rh reporting the patient informed his shoulder was much better, but still sore. Patient also informed he was positive for SARS-Cov-2 from 07Dec2020 to 28Dec2020.He had mild symptoms. The patient recovered with sequel from the events on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/01/2021,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Body temperature', 'COVID-19', 'Chills', 'Headache', 'Heart rate', 'Heart rate increased', 'Hyperhidrosis', 'Oxygen saturation', 'Oxygen saturation decreased', 'Pain', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1004407,,30.0,M,"One week after the second vaccine I developed Bell's Palsy; This is a spontaneous report from a contactable other health professional reported for himself. A 30-year-old male patient received second dose of bnt162b2, via an unspecified route of administration in left arm on 11Jan2021 11:00 at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included terbinafine, cetirizine hydrochloride (ZYRTEC), multivitamin. The patient previous received first dose of bnt162b2, via an unspecified route of administration in right arm on 21Dec2020 11:00 for covid-19 immunization. The patient experienced one week after the second vaccine, he developed bell's palsy on 18Jan2021 with outcome of not recovered. The event was reported as non-serious. The adverse event result in a visit to emergency room/department or urgent care. Treatment Prednisone, valacyclovir was received for the adverse event. Facility where the most recent COVID-19 vaccine was administered: School or Student Health Clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported event Bell's palsy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/18/2021,7.0,SCH,TERBINAFINE; ZYRTEC,,,,,['Facial paralysis'],2,PFIZER\BIONTECH, 1004409,LA,53.0,F,"She thinks she had a delayed anaphylactic shock she was definitely in shock; hypothermic; her adrenal glands are over compensating, working over load; she was having diarrhea; throwing up; she went from cold to profusely sweating back to having chills; she went from cold to profusely sweating back to having chills; she had no blood to her extremities; severe abdominal cramps; headache; her body is just weak; she was feeling dizzy; Her legs were cramping; her heart was racing fast; her lactic acid was really high; This is a spontaneous report from a contactable Nurse. A 53-years-old female patient receive the first dose of bnt162b2 (BNT162B2; Lot # EL3249) vaccine , via an unspecified route of administration in the right deltoid on 13Jan2021 15:55 at single dose for Covid-19 immunisation . Medical history included hypertonic bladder from an unknown date., drug hypersensitivity from an unknown date , migraine from an unknown date. She had migraines. Concomitant medication included solifenacin succinate (VESICARE), buspirone hydrochloride (BUSPAR), spironolactone (SPIRONOLACTONE). The patient previously took flu vaccine VII, bactrim and experienced drug hypersensitivity. The patient stated she thinks she had a delayed anaphylactic shock she was definitely in shock on an unknown date with outcome of unknown , hypothermic on an unspecified date with outcome of unknown , her adrenal glands are over compensating, working over load on an unspecified date with outcome of unknown , she was having diarrhea on an unspecified date with outcome of not recovered , throwing up on an unspecified date with outcome of unknown , she went from cold to profusely sweating back to having chills on an unspecified date with outcome of unknown , she had no blood to her extremities on an unspecified date with outcome of unknown , severe abdominal cramps on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of not recovered , her lactic acid was really high on 18Jan2021 with outcome of unknown , her body is just weak on an unspecified date with outcome of not recovered , her heart was racing fast on 18Jan2021 with outcome of unknown , she was feeling dizzy on 22Jan2021 with outcome of unknown , her legs were cramping on 19Jan2021 with outcome of unknown. The patient was hospitalized because of the events from 16Jan2021 to 17Jan2021. The patient underwent lab tests and procedures which included blood lactic acid: high on unknown date, chest x-ray: unknown results on unknown date, computerised tomogram: unknown results on 18Jan2021 , electrocardiogram: unknown results on unknown date. The patient was given fluids, Toradol and Xanax to treat the events. Further information has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/13/2021,01/18/2021,5.0,PVT,VESICARE; BUSPAR; SPIRONOLACTONE,,Medical History/Concurrent Conditions: Migraine (She had migraines.); Overactive bladder (For Bladder Overactive bladder); Sulfonamide allergy,,,"['Abdominal pain', 'Asthenia', 'Blood lactic acid increased', 'Chest X-ray', 'Chills', 'Computerised tomogram', 'Diarrhoea', 'Dizziness', 'Electrocardiogram', 'Feeling cold', 'Headache', 'Hyperhidrosis', 'Hypothermia', 'Muscle spasms', 'Palpitations', 'Vomiting']",1,PFIZER\BIONTECH, 1004412,GA,40.0,F,"Next day after the shot i feel a pain under my left arm. Days later the pain increase and i think is lymphoma; Next day after the shot i feel a pain under my left arm. Days later the pain increase and i think is lymphoma; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL1283, expiry: unknown), via an unspecified route of administration in the left arm on 15Jan2021 07:00 at a single dose for COVID-19 immunization. The patient has no medical history and no known allergies. The patient has no Covid prior to vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient mentioned that the next day after the shot (16Jan2021 at 05:30), the patient feel a pain under her left arm; days later, the pain increased, and she thinks it is lymphoma. The patient was not tested for Covid post vaccination. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/16/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Axillary pain', 'Pain']",1,PFIZER\BIONTECH, 1004417,,,M,"severe diarrhea; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter was to report a possible side effect. The patient experienced severe diarrhea in Jan2021. Outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,['Diarrhoea'],UNK,PFIZER\BIONTECH, 1004419,TX,69.0,F,"developed COVID symptoms/diagnosed positive in Covid19/ tested positive for Covid; developed COVID symptoms/diagnosed positive in Covid19/ tested positive for Covid; This is a spontaneous report from a contactable nurse (patient). This nurse reported same event for two patients (patient and her husband), this is the first of two reports, the report for patient herself. A 69-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL0142, expiration date unknown), via an unspecified route of administration in arm (reported as deltoid) on 02Jan2021 at single dose for COVID-19 immunization. The patient denied relevant medical history. Concomitant medications were not reported. The patient got her first dose on 02Jan2021, and on 08Jan2021 developed COVID symptoms. On 11Jan2021, she tested positive for COVID-19/diagnosed positive in COVID-19. The reporter nurse think they were exposed sometime at that pharmacy, she mean there was a lot of people in the line. Tomorrow (unspecified) was supposed to be second dose and his family physician didn't know if he should get that second dose. The outcome of events was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021064940 Same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/08/2021,6.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1004429,FL,67.0,M,"Sharp pain in his heart; Wild palpitations; Extreme erratic heart beat; wiped out; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1248), via an unspecified route of administration on 11Jan2021 at single dose at left arm for covid-19 immunisation. Medical history included Lyme's disease from 09Jun2018 and ongoing, ongoing heart issues, cholesterol lowering and swelling (He was on a water pill for swelling). Concomitant medication included atenolol for heart medication, pitavastatin calcium (LIVALO) for cholesterol lowering. Patient was calling to report a negative reaction with Covid-19 vaccine. Four hours after the injection he laid down in bed and was relaxing on 11Jan2021. He felt a sharp pain in his heart. It was about 1 to 1.5 inches to the right of his nipple. It felt like a knife being jabbed in his chest. This only happened once. His heart was having wild palpitations. He had an extreme erratic heart beat lasting 30-40 seconds. It was terrifying. He had a lot of irregular heart beats for 3-4 days. He was wiped out and unable to get out of bed for 5 days. He had an MRI on 21Jan2021. He was waiting on the results. The erratic heart beats come and go. They were not as pronounced as the first week. He was not getting the second dose. He had not had a flu shot for the last 3 years. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. Outcome of event sharp pain in his heart recovered with sequel on 11Jan2021, wild palpitations was recovered in Jan2021, extreme erratic heart beat was recovering, wiped out was recovered with sequel on 16Jan2021. The report was considered as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,PVT,ATENOLOL; LIVALO,Heart disorder; Lyme's disease,Medical History/Concurrent Conditions: Cholesterol low; Swelling (He was on a water pill for swelling.),,,"['Angina pectoris', 'Asthenia', 'Heart rate irregular', 'Magnetic resonance imaging', 'Mobility decreased', 'Palpitations']",1,PFIZER\BIONTECH, 1004432,MO,22.0,F,"Fainted; Dizziness; Heart racing; This is a spontaneous report from a contactable consumer reported for herself. A 22-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 15:45 at single dose in left arm for COVID-19 immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), escitalopram oxalate (LEXAPRO), spironolactone and Birth control product. The patient experienced fainted morning after 1st dose with dizziness and heart racing on 22Jan2021 06:45 - had to go to ER. The patient received anti-nausea and heart monitor as treatment for the adverse event. Events outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/22/2021,1.0,PVT,VYVANSE; LEXAPRO; SPIRONOLACTONE,,,,,"['Dizziness', 'Palpitations', 'Syncope']",1,PFIZER\BIONTECH, 1004433,,54.0,F,"bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tightness; numbness on the left side of [her] face, right under the eye; temporary rash she had on the left side of her face, under her cheek; toes crowded back; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose ""on the left side"" for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She stated feeling nauseous right after the shot and mentioned not eating breakfast. She described having bilateral leg paralysis which she also qualified as locked to the point where she could hardly walk. She added that her leg muscles were so tight that her toes crowded back. She then explained having numbness on the left side of her face, right under the eye and that her jaws felt locked, like a tightness. She specified she didn't know if she really felt tightness in her jaws because of the intensity of her bilateral leg paralysis. She then described a temporary rash she had on the left side of her face, under her cheek. She said her experience occurred two hours post injection on 21Jan2021 and was resolved in Jan2021 after taking a muscle relaxer. She asked if shellfish is in the vaccine. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,UNK,,,,,,"['Diplegia', 'Hypoaesthesia', 'Immediate post-injection reaction', 'Mobility decreased', 'Muscle tightness', 'Nausea', 'Rash', 'Trismus']",1,PFIZER\BIONTECH, 1004434,NE,,M,"he is disabled and has congestive heart failure.; This is a spontaneous report from a contactable consumer (patient). A male patient (age: 74, unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated he was disabled and had congestive heart failure. The patient stated that he read the CDC had decided to only give one shot, everything he read on the website saying designed for 2 doses of the covid 19 vaccine. He received his shot and they might not be able to give 2 doses. The outcome of event was unknown. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['No adverse event'],1,PFIZER\BIONTECH, 1004437,WI,17.0,F,"She passed out.; This is a spontaneous report from a contactable consumer (parent). A 17-year-old female patient (daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL1284) on 22Jan2021 11:45 AM at left arm at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. No known allergies. Patient was not pregnant. Patient did not have COVID prior vaccination, and did not have other vaccine in four weeks, did not other medications in two weeks. The patient experienced passed out on 22Jan2021 12:00 PM. Treatment included they had her lay on the ground with her knees up and cold compresses. Patient did not test COVID post vaccination. The outcome of event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Loss of consciousness'],1,PFIZER\BIONTECH, 1004439,NC,,F,"cancerous cells; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her first dose of PFIZER-BIONTECH COVID-19 VACCINE on 14Jan2021. She had a surgical procedure Wednesday 20Jan2021, and was prescribed a cephalosporin antibiotic for 7 days post-procedure precautionary remove cancerous cells somebody suggested, it was a doctor. She was asking if there are any drug interactions between the antibiotic and the vaccine. Also, a doctor suggested that she take a dose of ibuprofen prior to her second vaccine dose on 05Feb2021. It was also reported the patient had a little surgical procedure with the Dermatologist this week (in Jan2021) and she just wanted to know if the antibiotic, Cefadroxil, has any contraindications that would compromise her vaccine. She had to take it for 7 days and it was to prevent bacterial infections. It was a procedure on her leg and she was also given an antibiotic cream also to help. The patient felt it was more important for her with having this vaccine and that was why she was calling. The event outcome was unknown. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,,,UNK,,,,,,['Unevaluable event'],1,PFIZER\BIONTECH, 1004445,,,U,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable Pharmacist. A healthcare worker of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive for covid-19 on an unspecified date with outcome of unknown. Information about Lot/Batch has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 1004449,MN,40.0,M,"Guillain Barre syndrome/Symptoms started with 2 fingers tingling; This is a spontaneous report from a contactable nurse reporting for a patient. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via intramuscular on 09Jan2021 at single dose in left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular on 22Dec2020 at single dose in left arm at the age of 39-year-old for COVID-19 immunization. Reported he was diagnosed with Guillain Barre syndrome. Symptoms started with 2 fingers tingling on 11Jan2021. Progressively increasing in severity. Now had numb fingers and toes. Initiating IV therapy on 22Jan2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset. More information such as complete medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/11/2021,2.0,PVT,,,,,,"['Guillain-Barre syndrome', 'Hypoaesthesia', 'Paraesthesia']",2,PFIZER\BIONTECH,OT 1004450,CO,34.0,F,"Transient bilateral lower extremity neuropathy; periorbal and facial neuropathy; severe low back pain; tinnitus; This is a spontaneous report from a contactable other health professional (patient) reporting for herself. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3248), intramuscular at left arm on 20Jan2021 at single dose for covid-19 immunization. Medical history was none. No pregnant at the time of vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 via intramuscular at left arm on 30Dec2020 for covid-19 immunization. Facility where the most recent COVID-19 vaccine administered was nursing home/senior living facility. The patient experienced transient bilateral lower extremity neuropathy, tinnitus, periorbital and facial neuropathy, severe low back pain on 20Jan2021 with outcome of unknown. No treatment was received for the adverse events. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/20/2021,0.0,SEN,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Back pain', 'Neuropathy peripheral', 'Tinnitus']",2,PFIZER\BIONTECH,OT 1004452,NC,,M,"severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis; severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis; severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis; lymphadenopathy as an MRI showed cervical lymph node enlargement; This is a spontaneous report from a contactable physician. A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The patient stated ""Last Tuesday, I received my second vaccine. By Thursday I had severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis. MRI showed cervical lymph node enlargement."" The patient was hospitalized for severe left upper girdle pain in my shoulder and neck. eventually i was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis (fasciitis) for 4 days. The patient underwent lab tests and procedures which included magnetic resonance imaging: cervical lymph node enlargement, pain assessment: 2-3 out of 10 on Jan2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported left upper girdle pain in shoulder and neck/ inflammatory fasciitis and the administration of the COVID-19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,01/19/2021,01/21/2021,2.0,UNK,,,,,,"['Arthralgia', 'Fasciitis', 'Lymphadenopathy', 'Magnetic resonance imaging abnormal', 'Neck pain']",2,PFIZER\BIONTECH, 1004454,OK,,M,"It was hurting really bad this morning about where your heart is; felt like my chest was caving in for 5-6 hours; felt like a mule had kicked him in the chest; both sides of my ribs was hurting like I had been rodeoing/they were real sore/rib cage on both sides hurt real bad; felt drugged; dizzy feeling/lightheaded; headache; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunization. The patient medical history included blood pressure (abnormal). Concomitant medications included 5 mg of a blood pressure pill and male enhancement stuff. The patient stated he went to the health department and they sent him somewhere else to get the shot on Wednesday (Jan2021). It was the first dose of the vaccine and he had a little headache that night (Wednesday) at about 20:00 and he took a couple of aspirin. Got up on 21Jan2021 morning both sides of his ribs was hurting like he had been rodeoing, they were real sore, also reported as his rib cage on both sides hurt real bad and about 6 hours later it wore off. Thursday (Jan2021) he felt drugged, dizzy feeling and lightheaded, around 11:00 it dissipated. On 22Jan2021 morning when he got up he felt like his chest was caving in for 5-6 hours (also reported as he felt like a mule had kicked him in the chest) but he went on out and did his thing and it was 5 hours like that. It was hurting really bad on 22Jan2021 morning about where his heart was. He didn't know if he was having a heart attack. His symptoms were gone he was 98-99% better than he was. It wore itself down through the morning hours. By 10:30-11:00 it was about 50% gone and by 13:00 it was gone. He didn't think it went away, it was kind of hiding back there. It made his wonder if he should take the second shot. He had never had no Corona. The problems came when he had the shot. He took 5 mg of a blood pressure pill and male enhancement stuff that his doctor did warn him to tell them he was on it if he ever go to the ER. His second shot was scheduled for 10Feb2021. Wanted to know if this was a side effect that made him feel bad and hurt half the day and by the afternoon it's gone. Wanted to be sure since he was to get the booster. Wanted to know is this normal and what to do. The outcome of the events of the event rib pain was recovered on 21Jan2021, of the events felt drugged & dizzy feeling/lightheaded was recovered in Jan2021, of the other events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure abnormal,,,"['Blood pressure abnormal', 'Chest discomfort', 'Chest pain', 'Dizziness', 'Feeling abnormal', 'Headache', 'Musculoskeletal chest pain']",1,PFIZER\BIONTECH, 1004455,MO,25.0,F,"Passed out; Pulseless for 30 seconds; Feel dizzy and nauseous; Feel dizzy and nauseous; This is a spontaneous report from a contactable Other Health Professional (patient). A 25-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown since not available/provided to reporter at the time of report completion), via an unspecified route of administration at left arm on 22Jan2021 11:45 at single dose for COVID-19 immunization at a Nursing Home/Senior Living Facility. The patient's medical history included known allergies: Sulfa and poppy seed. No other known medical history/conditions. For concomitant medications, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin, clarithromycin (BIAXIN) and cefaclor (CECLOR), and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination. After receiving the vaccine, the patient was sitting in the observation area for about 10 minutes when she started to feel dizzy and nauseous. She raised her hand up and called for the nurse to come over. She passed out. She was pulseless for 30 seconds and they had to begin giving her CPR chest compressions. She woke up lying on the ground and was taken to the emergency room (ER) where they ran tests to see how she was doing and for observation for several hours. The patient was ""discharged"" this afternoon and was doing better. The events result in emergency room/department or urgent care. Treatment was received for the events, ER observation and care, and CPR chest compressions. The patient underwent lab tests and procedures which included test on 22Jan2021: unknown results. The outcome of events at the time of last observation was recovering. The reporter's assessment of the events was non-serious, no results in death, no life threatening, not causing/prolonging hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Information on the lot/batch number has been requested.; Sender's Comments: The reported passed out and pulseless for 30 seconds were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. However, considering the clinical course and medical history, other cause(s)/confounding factors cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,SEN,,,Medical History/Concurrent Conditions: Food allergy (Known allergy: poppy seed); Sulfonamide allergy (Known allergies : Sulfa),,,"['Dizziness', 'Loss of consciousness', 'Nausea', 'Pulse absent', 'Resuscitation']",1,PFIZER\BIONTECH, 1004456,,,F,"her blood pressure which was 208/189; really bad shakes a fever of 102 degrees; really bad shakes a fever of 102 degrees; This is a spontaneous report from a contactable other HCP(patient). A 46-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. Medical history included COVID-19 in Nov2020/Dec2020. The patient's concomitant medications were not reported. 12 hours later the patient had really bad shakes a fever of 102 degrees and she checked her blood pressure which was 208/189. She went to the Emergency Room to get checked out and she was told that it was probably due to the vaccine. Patient wanted to know if she should receive the second dose of the vaccine since she had this type of reaction after the first dose. She had COVID-19 in Nov2020/Dec2020. She was told in the Emergency Room that since she had a previous COVID-19 infection that she would experience worse side effects from the first dose of the COVID-19 dose than the second dose. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported blood pressure increased. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: COVID-19 (she had COVID-19 in Nov2020/Dec2020),,,"['Pyrexia', 'Tremor']",1,PFIZER\BIONTECH, 1004472,WA,68.0,M,"Sagging left lip; rash under arms; This is a spontaneous report from a contactable other hcp (patient). A 68-years-old male patient received bnt162b2 (BNT162B2, brand: Pfizer) first dose, via an unspecified route of administration at arm left on 20Jan2021 10:30 AM at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Patient had no allergies to medications, food, or other products. Concomitant medication included atorvastatin, vitamin d3, alpha lipoic acid received within 2 weeks of vaccination. The patient experienced sagging left lip on an unspecified date with outcome of unknown, rash under arms on an unspecified date with outcome of unknown. No treatment was received. Prior to vaccination, the patient was not diagnosed with COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, the possible contribution of suspect vaccine BNT162B2 to the event facial droop cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,,,PVT,ATORVASTATIN; VITAMIN D3; ALPHA LIPOIC ACID,,,,,"['Facial paralysis', 'Lip disorder', 'Rash']",1,PFIZER\BIONTECH, 1004473,WI,56.0,F,"chest soreness/pain; pain with breathing/hurt to breathe; severe fatigue; soreness at injection site; This is a spontaneous report from a contactable other healthcare professional (hcp), reporting for herself. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot ELO142) , on 18Jan2021 at 09:00 intramuscular in Right arm at single dose for COVID-19 immunization.Medical history included allergy to Shellfish. Patient was not pregnant. Concomitant medication included ibuprofen (ADVIL) prophylactically, at 2DF daily on 18Jan2021 and at 2 DF each day through on 19Jan2021; vitamin D3; fish oil; ascorbic acid (VITAMIN C) and cyanocobalamin (VITAMIN B12). The patient experienced chest soreness/pain, pain with breathing/hurt to breathe, severe fatigue, soreness at injection site, on 14Jan2021 (as reported). Events were also described as follows: patient prophylactically took 2 ibuprofen 30 minutes before vaccine on 18Jan2021 at 08:30 am and got the vaccine on 18Jan2021 at 9am. She just had soreness at injection site that evening. She kept up with the ibuprofen (only 2 doses each day) through on 19Jan2021. On 21Jan2021 she felt severe fatigue and later in the evening she started to feel chest soreness/pain and pain with breathing. It felt muscular but she went to emergency department (ED) because it hurt to breathe. They did a cardiac and PE work up which was negative. The pain was relieved by Toradol IV. She was discharged from emergency department (ED) . She took more ibuprofen on 22Jan2021 when she started to feel the same, but lesser, symptoms and the pain went away. On 23Jan2021, so far patient felt okay. The final outcome of the events was reported as recovering.; Sender's Comments: Based on the temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events ""chest soreness/pain, pain with breathing/hurt to breathe"". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/18/2021,0.0,PVT,ADVIL [IBUPROFEN]; VITAMIN D3; FISH OIL; VITAMIN C [ASCORBIC ACID]; VITAMIN B12 [CYANOCOBALAMIN],,Medical History/Concurrent Conditions: Shellfish allergy,,,"['Cardiac function test normal', 'Cardiovascular evaluation', 'Chest pain', 'Fatigue', 'Injection site pain', 'Painful respiration', 'Pulmonary function test normal']",1,PFIZER\BIONTECH,OT 1004474,,,F,"patient tested positive for COVID; patient tested positive for COVID; Had the 1st dose of COVID 19 vaccine last 26Dec20 - Due for 2nd dose on 27Jan21; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 26Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive for COVID and quarantined on an unspecified date. The patient had the 1st dose of COVID 19 vaccine last 26Dec2020, will be due for 2nd dose on 27Jan2021. The patient asked if it is safe to have the 2nd dose of the vaccine. The patient underwent lab tests and procedures which included COVID test: positive on an unspecified date. The outcome of events was unknown. Information about lot/batch has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/26/2020,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1004476,MI,50.0,M,"Following day, bloody stool-diarrhea.; Nausea wanting to vomit; Nausea wanting to vomit; massive diarrhea; severe fatigue; chills; diaphoresis; This is a spontaneous report from a contactable nurse (patient). A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3248), via Intramuscular on left arm on 28Dec2020 at 10:00 AM at single dose for COVID-19 immunization. The relevant medical history included hypertension. Concomitant medications included acetaminophen. The patient experienced nausea wanting to vomit, massive diarrhea, severe fatigue, with chills and diaphoresis. Following day, bloody stool-diarrhea. No treatment received for the events. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. The outcome of the events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on bloody stool-diarrhea reported cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,,,PVT,ACETAMINOPHEN,,Medical History/Concurrent Conditions: Hypertension,,,"['Chills', 'Diarrhoea', 'Fatigue', 'Haematochezia', 'Hyperhidrosis', 'Nausea']",1,PFIZER\BIONTECH,OT 1004481,AZ,,F,"tested positive for Covid19; tested positive for Covid19; chills; nausea; headache; Loss of smell; This is a spontaneous report from a Pfizer Sponsored Program Pfizer. A contactable female consumer of an unspecified age reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for covid-19 on unspecified date, chills, nausea, headache, loss of smell on 13Jan2021 with outcome of unknown. Patient second dose of Covid will be on 02Feb2021. Information on Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/13/2021,2.0,UNK,,,,,,"['Anosmia', 'COVID-19', 'Chills', 'Headache', 'Nausea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1004483,TX,,F,"COVID-19 virus test positive (swab test); COVID-19 virus test positive (swab test); bad allergies; feeling not so good; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 15Jan2021/16Jan2021 the patient started feeling not so good, she had bad allergies. She went to an urgent care and they did a COVID-19 virus test (swab test) and she tested positive. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'Feeling abnormal', 'Hypersensitivity', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1004490,TX,70.0,M,"developed Covid symptoms/diagnosed positive in Covid19; developed Covid symptoms/diagnosed positive in Covid19; This is a spontaneous report from a contactable nurse (patient's wife). This nurse reported same event for two patients, this is the second of two reports. A 70-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration in arm (reported as deltoid) on 02Jan2021 at single dose for COVID. Medical history included hypertension and bad cholesterol. Concomitant medication included levothyroxine (low dose of it), amlodipine besilate (EMADINE) for hypertension, losartan for hypertension, levothyroxine sodium (SYNTHROID) for bad cholesterol, lovastatin (LOVASTIN) for bad cholesterol. The patient got his first dose on 02Jan2021, and on 08Jan2021 developed Covid symptoms. On 11Jan2021, he tested positive for Covid19/diagnosed positive in Covid19. The reporter nurse think they were exposed sometime at that pharmacy, she mean there was a lot of people in the line. Tomorrow (unspecified) was supposed to be second dose and his family physician didn't know if he should get that second dose. The outcome of events was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021061825 Same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/08/2021,6.0,UNK,LEVOTHYROXINE; EMADINE [AMLODIPINE BESILATE]; LOSARTAN; SYNTHROID; LOVASTIN,,Medical History/Concurrent Conditions: Blood cholesterol abnormal; Hypertension,,,"['COVID-19', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1004492,NC,75.0,F,"severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tiredness; muscle aches; a little swelling in her face; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK5730) intramuscularly on arm left on 09Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included heart problems from May1966 and ongoing (heart problems/She had open heart surgery at that time and had stents put in a couple of times since then), bone spurs and arthritis in her feet. Concomitant medications were none. Patient used to receive unspecified injections in her feet because she has bone spurs and arthritis in her feet. Patient experienced heart pains in Jan2021, dizziness on 10Jan2021, not feeling quite right on 10Jan2021, severe chills on 11Jan2021, fever on 11Jan2021, nauseated in Jan2021, threw up in Jan2021, tiredness in Jan2021, muscle aches in Jan2021, a little swelling in her face in Jan2021, weakness in Jan2021. The outcome of the events was unknown. Patient received her first Pfizer vaccine on 09Jan2021. Patient explains she has had adverse reactions to the vaccine ever since she received it. Patient confirms she took the vaccine on Saturday, 09Jan2021. On Sunday, 10Jan2021, she started having a little bit of dizziness and feeling just not quite right. Sunday night, she went to bed and woke up at around 3:30 a.m. with severe chills and a fever. Her fever was a little over a 100. She states it took about 2 hours to get her chills under control. She took 2 Tylenol at that time. That day (11Jan2021) she ran fever off and on all day. The next day (12Jan2021), she seemed to be better. She had a low-grade fever, but she was better. She was just kind of tired from the day before. But then, that night, she ended up with the same thing again- she woke up at 4am with chills. Her fever had gone up 101.7, and she ended up taking 2 Tylenol and so forth. She got up that morning around 10 am, and was nauseated. She threw up that morning. She felt really bad. She was experiencing tiredness, muscle aches. (At this point it was about Tuesday (12 Jan) or Wednesday (13 Jan). There was one day during the day, she felt better, but a day went by and she ended up having the chills and fever again. Every time her fever kept going up. Her fever this particular night was 102 something. About Wednesday night, when she had the chills and fever, her fever went up to 103.8. That next morning, she called her doctor's office and tried to get an appointment. She could not get an appointment with the office. Her office ended up doing a televist and sending her a Prednisone pack to take for the reaction that it seemed she was having. She started the prednisone pack which seemed to take the fever down and the chills ended up stopping. Caller clarifies further she believes she has recovered from the fever and chills. The Prednisone pack seemed to kind of make those symptoms go away. However, she still felt really bad. This went on all weekend again. Tuesday of this week, (19Jan2021), she still felt really bad. She called her doctor again and her doctor wouldn't see her because of the symptoms she is having after receiving the COVID-19 vaccine are the same symptoms of the actual COVID-19 virus. She clarifies further the adverse effects of the shot are also same ones as the COVID-19 virus. Her doctor suggested she either go to the Emergency Room or to an Urgent Care. Patient called the Urgent Care and they were able to do a COVID test on her to check and see if she did have COVID-19. She confirms this test was on Tuesday, 19Jan2021. The results came back negative. However, they did another swab test. The patient is unsure what the second swab test was for but was told it would be a couple days before they would have the results of this test. At this point, they put her on a Z-pak. Patient mentions she has heart problems. She has nitroglycerin for any problems that she has. She started having some heart pains when she was down to about 3 tablets of that Prednisone pack she was taking. When she took one of the Prednisone tablets, within 30 minutes of taking it, she started having chest pains. She clarifies it started in her throat and went down to her chest. She took 2 nitroglycerin's to get her feeling back to normal/better. Caller doesn't provide NDC, Lot number or expiration date for the Nitroglycerin she took when probed. Patient mentions her cheeks had been pink. She doesn't really know but she may have a little swelling in her face. She can't figure that out herself. She was experiencing dizziness and weakness. Today is the first day which is the 13th day after receiving the vaccine, she has felt like trying to get this stuff together and her thoughts together to try and figure out what is going on with her. She tried calling her primary doctor and this urgent care and she couldn't get anybody to see her. Patient got her Prednisone pack filled at (Pharmacy name), (Address details) The prescription was issued to her on Thursday, 14Jan2021, but she didn't start taking the pack until Saturday. On Saturday, that's when her fever had went up to 103 and she knew she needed to take the Prednisone pack. They are 4mg tablets and she started out taking 6 tablets the first day and then her dose decreased every day. NDC: 164793723369, Lot: 20K0041P, she believes the second digit is a zero and not a ""D"", Expiry date: Aug2022. Z-pak: patient states she no longer has the box, therefore she is not sure of the dose and how it was prescribed. She makes the comment she believes the first day it was 2 tablets. NDC: Unknown, Lot: 7996030, Expiry: Feb2022. She clarifies she did not take Tylenol as stated earlier. She took Kirkland's brand, Acetaminophen. They are 500mg tablets. She provides the following product information: Lot: 2GE1779B. The last digit is either a ""B"" or an 8/, Expiry date: May2015; patient clarifies she knows they just bought this bottle, but she thinks her husband put his extra pills in the wrong bottle. No further details were provided or obtained in regard to this statement. The patient wants to find out about this and what is going on with her. To her understanding and her reading information, she is scheduled to take her next shot 27Jan2021. She is not supposed to take it then, correct? Investigations: patient confirms she had a COVID-19 test done (she is not sure what type of test- PCR, Antibody, etc), they swabbed her nose and the results came back negative. She had a second test done, where they swabbed her nose again, but she hasn't got the results back. She isn't sure what that test is for. Vaccination Facility Type was Hospital. Additional Vaccines Administered on Same Date of the Pfizer Suspect was no. Did any AE(s) require a visit to: Emergency Room was No, she is trying to keep herself out of the hospital. Physician Office? Her doctor would not see her but offered a virtual visit. She did go to the Urgent Care. Prior Vaccinations (within 4 weeks): Caller states she went to the foot doctor on 22Dec2021 (pending clarification). She was given injections in her feet because she has bone spurs and arthritis in her feet. Patient does not know exactly what kind of injection it was. She confirms she has no name, ndc, lot and expiry date for the injections she received. Patient asks the call handler, what should she have done on this? She was lost. She read the information that was provided to her and she doesn't feel there was sufficient information on what to do if you had a reaction. She guesses the best thing she can be told is to call #. She didn't know it was a # emergency. She didn't know what she was supposed to do. It was hard for her to get any information out of anybody as to what to do. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/01/2021,,PVT,,Heart disorder (She had open heart surgery at that time and had stents put in a couple of times since then),Medical History/Concurrent Conditions: Arthritis; Bone spur; Open heart surgery; Stent placement,,,"['Angina pectoris', 'Asthenia', 'Chills', 'Dizziness', 'Erythema', 'Fatigue', 'Feeling abnormal', 'Myalgia', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative', 'Skin discolouration', 'Swelling face', 'Vomiting']",1,PFIZER\BIONTECH,OT 1004495,,,F,"was not able to get out of bed or have lights on; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Unbearable Headache; Continues eye twitching; Extremely tired; had a hard time walk due to the body aches; had a hard time walk due to the body aches; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced Knot, Swollen and heat at the injection site, unbearable Headache that pain relievers would not help, Continues eye twitching, Extremely tired, and was not able to get out of bed or have lights on. She had a hard time walk due to the body aches. Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Mobility decreased cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Blepharospasm', 'Fatigue', 'Headache', 'Injection site induration', 'Injection site swelling', 'Injection site warmth', 'Mobility decreased', 'Pain', 'Photophobia']",1,PFIZER\BIONTECH, 1004496,,,F,"not able to get out of bed or have lights on; Unbareable Headache; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Continues eye twitching; Exteremly tired; 102.5 fever; Body Aches; had a hard time walk due to the body aches; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose BNT162B for COVID-19 immunization and experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers would not help, continues eye twitching, extremely tired, and was not able to get out of bed or have lights on. she had a hard time walk due to the body aches. After second shot, she also experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers would not help, continues eye twitching, extremely tired, and was not able to get out of bed or have lights on, she had a hard time walk due to the body aches, and 102.5 fever that didn't want to come down. Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Considering a vaccine-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Blepharospasm', 'Fatigue', 'Headache', 'Injection site induration', 'Injection site swelling', 'Injection site warmth', 'Mobility decreased', 'Pain', 'Photophobia', 'Pyrexia']",2,PFIZER\BIONTECH, 1004498,,,M,"encephalitis; has stopped walking; diarrhea; getting sick/He is not doing well; This is a spontaneous report from a Pfizer Sponsored program. A non-contactable consumer reported for her brother that a male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EE8492), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Her brother was hospitalized after the COVID vaccine and has stopped walking. He was not doing well. He also had diarrhea. Her brother did get the vaccine and now he has encephalitis. He was in the hospital but he is out now. He got the vaccine and then started getting sick. And he is not the only one. She could send in evidence of all of this. The consumer was on the Internet and (social media name) reading about the COVID Vaccine. She has complaints about it not being FDA approved, and not being approved to prevent COVID-19. She just saw in another location that 30 people in a nursing home died. 30 people have died in nursing homes. There are 32 side effects and she has all 32 of them. She wanted to speak with the scientists or manufacturers of the COVID vaccine. Someone in development. She is really concerned about the vaccine. It has many side effects. It is not FDA approved. It is also not approved to prevent COVID-19. Even if you get the vaccine you could still get COVID. It is not studied long term. Even doctors have said that. There have been many deaths. You don't know what will come of it. She does not know why Pfizer does not pull this back. She has seen videos that have been taken down because Pfizer does not want people to see the real news. They need to show these on the real news. Consumer clarified that she did not have any side effects. She did not take the vaccine. She does not take any vaccines. People need to learn about their nutrition. They need to tell people to take Zinc, Vitamin C, stop eating animal products and meat. She is vegan and she has never gotten sick. No flu or anything. Meat lowers your immune system. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,"['Diarrhoea', 'Encephalitis', 'Gait disturbance', 'General physical health deterioration', 'Illness', 'Malaise', 'Mobility decreased']",UNK,PFIZER\BIONTECH, 1004500,CA,,M,"11 days after he tested positive for Covid; 11 days after he tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient (consumer's husband) of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient got his 1st dose of vaccine and 11 days after he tested positive for Covid on 08Jan2021. He wanted to know if he could take the second dose of the Covid vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/08/2021,11.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1004503,MA,81.0,F,"severe back and leg pain and paresthesias bilaterally; severe back and leg pain and paresthesias bilaterally; severe back and leg pain and paresthesias bilaterally; This is a spontaneous report from a contactable other hcp. A 81-years-old female patient (not pregnant) received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 04Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: sulfa. No covid prior vaccination. No covid tested post vaccination. The patient's concomitant medications were not reported. The patient experienced severe back and leg pain and paresthesias bilaterally on 05Jan2021. The events resulted in hospitalization. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on a drug-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events severe back and leg pain and paresthesias cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/04/2021,01/05/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,"['Back pain', 'Pain in extremity', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 1004506,NC,72.0,M,"passing blood in stool; stomach cramping; This is a spontaneous report from a contactable consumer. A 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3248), via an unspecified route of administration at single dose on 18Jan2021 for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced passing blood in stool on 21Jan2021, stomach cramping on 20Jan2021, he had a couple of bowel movements this morning much more dark, not bright red blood like they were before on 22Jan2021. The patient was hospitalized for passing blood in stool from 21Jan2021 to 22Jan2021. The outcome of passing blood in stool was recovered on 22Jan2021, of stomach cramping was recovered on 21Jan2021, of had a couple of bowel movements this morning, much more dark, not bright red blood like they were before was unknown",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/18/2021,01/20/2021,2.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Abdominal pain upper', 'Haematochezia']",1,PFIZER\BIONTECH, 1004517,,,M,"Caller Got covid vaccine 12Jan- tested positive on 19Jan; Caller Got covid vaccine 12Jan- tested positive on 19Jan; This is a spontaneous report from a Pfizer sponsored program. A non-contactable male consumer (Patient) reported a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive on 19Jan2021 and wondering if it's okay to get the second dose. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/19/2021,7.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1004520,,,F,"passed out; This is a spontaneous report from a Pfizer sponsored program from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient woke up next morning on 21Jan2021 to go to bathroom and passed out. The outcome of event was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/21/2021,1.0,UNK,,,,,,['Loss of consciousness'],UNK,PFIZER\BIONTECH, 1004522,NJ,65.0,F,"immunocompromised patient; immunocompromised patient; tested positive for COVID/nasal congestion; tested positive for COVID/nasal congestion; This is a spontaneous report from a contactable physician. A 65-year-old female patient (nurse) received bnt162b2 (Pfizer BioNTech COVID 19 vaccine), via an unspecified route of administration, the first dose on an unspecified date and the second dose on 14Jan2021, at single dose for covid-19 immunisation. The patient's medical history included immunocompromised. Concomitant medications were not reported. The immunocompromised patient received her second dose of Pfizer vaccine on 14Jan2021. On 20Jan2021, she developed nasal congestion and her son became sick the same day. Both tested positive for COVID. The physician asked would you consider giving the monoclonal ab to her? Physician knew the expectation was mild disease not severe but would you consider giving her the monoclonal? Outcome of the events was unknown. Information about lot and batch number had been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported ""tested positive for COVID"".",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/20/2021,,OTH,,,Medical History/Concurrent Conditions: Immunocompromised,,,"['COVID-19', 'Nasal congestion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1004529,OH,57.0,F,"COVID 19 PCR test positive; COVID 19 PCR test positive; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249, Expiry Date: 31May2021), intramuscularly into left arm on 15Jan2021 at a single dose for COVID Prevention. The patient medical history was not reported. There were no concomitant medications. The patient experienced tested positive for COVID on 21Jan2021 after taking 1st dose of COVID vaccine. The patient tested positive for COVID after taking 1st dose of COVID vaccine and was calling to see what she should do about her 2nd dose. The reporter saw in the news that patients can wait up to 6 weeks after receiving the first dose of the vaccine to receive the second, she wants to confirm this information. The reporter was calling on behalf of herself as the patient. The patient got the Pfizer COVID-19 Vaccine last Friday (15Jan2021), and she took a COVID 19 PCR test on 21Jan2021, and the results came back as positive for COVID 19 today 22Jan2021. The patient was wondering what the recommendations are for getting the second dose if a patient tested positive for COVID 19, following having received the first dose. The patient was not complaining about the product, because the product has not had time to work yet. The patient believed the seriousness, it was medically significant because she was losing work over it. Causality: The reporter (patient) did not believe that she got COVID 19 because of the vaccine not working, she just did not think the vaccine had enough time to work before she was exposed. She had no other vaccines on the same day. After she got her first dose, there were a few side effects that she had but nothing was bad, so she was mad when she realized she had gotten COVID, therefore it was not the vaccines fault she got COVID. The reporter had some questions about how this vaccine works in the body. Her doctor thought that her now having tested positive for COVID, that might increase the immune response. The outcome of events was unknown. Relatedness between reaction COVID-19 PCR test positive and bnt162b2, was unrelated by source of assessment: primary source reporter per method of assessment: Global Introspection.; Sender's Comments: Based on the information currently available, COVID-19 and lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/21/2021,6.0,UNK,,,,,,"['Adverse drug reaction', 'COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,OT 1004533,KY,72.0,M,"Her father also got the vaccine, and 1 day after had heaviness in his chest. He felt like his chest was trembling; Her father also got the vaccine, and 1 day after had heaviness in his chest. He felt like his chest was trembling; This is a spontaneous report from a contactable consumer. This consumer reported for a 72-year-old male patient (father) that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported her father got the vaccine, and 1 day after had heaviness in his chest, he felt like his chest was trembling (medically significant) on an unspecified date with outcome of unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Chest discomfort'],UNK,PFIZER\BIONTECH, 1004551,,,M,"sciatica; muscle spasms from his lower back to his toes on the right side; This is a spontaneous report from a contactable Consumer (patient's wife). A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose in the left arm for COVID-19 immunisation. The patient's medical history included twinge in his hamstring in Jan2021. Concomitant medications were not reported. The patient experienced a twinge in his hamstring 2 days before the vaccine but continues to play (reporter mentioned her husband is athletic). He received the first dose of the vaccine on 12Jan2021, played on the 13Jan2021 and could not play on 14Jan2021 two days after vaccine he experienced muscle spasms from his lower back to his toes on the right side and could not get out of bed (shot was in the left arm). Husband went to the hospital on 16Jan2021 and they discharged him and he went back on 17Jan2021 and did a magnetic resonance imaging (MRI) and diagnosed with sciatica and gave him oxycodone 10mg 1 mg 1 four times a day as needed, cyclobenzaprine 10 mg 1 every 8 hours, and gabapentin 100 mg 2 three times a day and a prednisone 6 pack. Reported not getting any better so took him to pain management and could not get comfortable and screamed the whole way over which was 20 minute ride and went in the office in a wheelchair. They gave him a steroid and told him to wait 1/2 hour. When leaving he experienced the worst spasm ever and they gave him Toradol and then additional steroid injections. Husband was able to walk out with a walker. Can only lay down, can not sit up and is bedridden. Spasms have stopped at the time of the phone call but still in pain. Having physical therapy (PT) come for consult. Husband insists on getting second dose. Husband was told at the hospital that another patient his age came in with the same symptoms as his after a dose of the COVID-19 vaccine. The events had not resolved. Information on the lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021058075 same reporter/drug/event, different patient",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/12/2021,01/14/2021,2.0,UNK,,,Medical History/Concurrent Conditions: Muscle pain,,,"['Bedridden', 'Gait disturbance', 'Magnetic resonance imaging abnormal', 'Mobility decreased', 'Muscle spasms', 'Pain', 'Sciatica', 'Screaming']",1,PFIZER\BIONTECH, 1004572,LA,87.0,M,"Nose bleed; Anemic; her husband's hemoglobin and hematocrit were low; her husband's hemoglobin and hematocrit were low; low on iron; This is a spontaneous report from a contactable consumer (wife of patient). An 87-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 at 16:00 at single dose in right arm for COVID-19 immunisation at the age of 87-year-old. Lot number was EL3249. Medical history included atrial fibrillation, by-pass surgery in 1999 then high blood pressure in 1999, gout (diagnosed before 1999, it was an on and off thing, he had flare ups, the last one was at Christmas time), High cholesterol (diagnosed in 2000 or 2001), diabetes, anemia. Concomitant medications included rivaroxaban (XARELTO) in 2014 for atrial fibrillation. Historical vaccine included flu vaccine in Sep2020 for immunization. On 20Jan2021, the patient was anemic. On 21Jan2021 at 02:30, nose bled. The patient just kept wiping his nose for thirty minutes before it stopped. On 20Jan2021, hemoglobin resulted 12.6, hematocrit was 3.9. The patient went to the hematologist the day before the report who said the patient was low on iron, hemoglobin and hematocrit were low, so he had to get an iron infusion the day of report for that (the patient went every three months and if his iron was low he got an infusion). The patient recovered from nose bled on 21Jan2021, the outcome of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/20/2021,1.0,UNK,XARELTO,,"Medical History/Concurrent Conditions: Anemic; Atrial fibrillation; Blood pressure high; Bypass surgery; Diabetes; Gout (diagnosed before 1999, on and off thing, he had flare ups, the last one was at Christmas time); High cholesterol (diagnosed in 2000 or 2001)",,,"['Blood iron decreased', 'Epistaxis', 'Haematocrit decreased', 'Haemoglobin decreased']",UNK,PFIZER\BIONTECH, 1004578,,38.0,F,"tunnel vision; Muscle fatigue; joint pain; This is a spontaneous report from a contactable other healthcare professional (HCP) communicated to a Pfizer colleague. A 38-years-old female patient (not pregnant) received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on right arm on 04Jan2021 at single dose for covid-19 immunisation. Medical history was None. The patient's concomitant medications were not reported. On 04Jan2021 the patient experienced tunnel vision, muscle fatigue, joint pain. No treatment was received for the events. The outcome of the events was not resolved. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of tunnel vision cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,PVT,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: other medical history: None",,,"['Arthralgia', 'Muscle fatigue', 'Tunnel vision']",1,PFIZER\BIONTECH, 1004587,CA,44.0,M,"Tested positive for COVID; Tested positive for COVID; first dose was 28Dec2020, wondered when he should get the second dose; This is a spontaneous report from a contactable health professional, the patient. A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EH9899), via an unspecified route of administration on 28Dec2020 (at the age of 44-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. On 13Jan2021, the patient tested positive for COVID. The patient was on his 10th day of quarantine ""tomorrow"" and wondered when he should get the second dose. The clinical outcome of ""Tested positive for COVID"" and ""first dose was 28Dec2020, wondered when he should get the second dose"" was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive for COVID based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/01/2021,4.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1004590,LA,71.0,F,"assume she had covid as well; assume she had covid as well; Feeling bad; Upper respiratory infection; This is a spontaneous report from a contactable consumer (patient). This consumer reported different events for two patients (herself and her husband), this is the first of two reports. A 71-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in left arm on 12Jan2021 16:30 at single dose for preventing covid. Medical history and concomitant medications were none. No prior vaccinations (within 4 weeks). She and her husband both received their first dose on 12Jan2021. Stated they both have covid. She was feeling bad last Friday (15Jan2021) and she went to urgent care and had a rapid test done that day that came back negative. Her husband went to urgent care this morning and had a rapid test that came back positive. She was told to assume she had covid as well. When she went to physician office for urgent care last Friday (15Jan2021), she was given medication for what they thought was an upper respiratory infection since her test last week came back negative. She was feeling better. The patient underwent lab tests and procedures which included Covid: negative on 15Jan2021. The outcome of feeling bad was recovering, for the rest of events outcome was unknown. No emergency room visit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021078480 same reporter/drug, similar events, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/15/2021,3.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Exposure to SARS-CoV-2', 'Feeling abnormal', 'SARS-CoV-2 test negative', 'Suspected COVID-19', 'Upper respiratory tract infection']",1,PFIZER\BIONTECH,OT 1004596,LA,,U,"Tested positive after receiving the vaccine; Tested positive after receiving the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 1st of two reports. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination. Medical history and concomitant medication were not reported. On an unspecified date, the reporter stated that she heard 2 other people tested positive after receiving the vaccine. The clinical outcome of she heard 2 other people tested positive after receiving the vaccine was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082667 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1004603,LA,,U,"she heard 2 other people tested positive after receiving the vaccine; she heard 2 other people tested positive after receiving the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is second of two reports. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unspecified date, the reporter stated that she heard 2 other people tested positive after receiving the vaccine. The clinical outcome of the event was unknown. Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082649 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1004609,TX,64.0,F,"type 2 diabetes mellitus; herpes pain has disappeared; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, at the first dose on 28Dec2020 (lot number: EJ1686, Expiry Date: Mar2021) at single dose in Left arm, via an unspecified route of administration at the second dose on 19Jan2021 (Lot Number: EL3249, Expiry Date: Mar2021) at single dose for prevent infection from Coronavirus. Medical history included ongoing essential hypertension and allergy, patient had genital herpes virus since age 26 and ongoing. Ongoing concomitant medications included chlortalidone from Oct2020 at 25mg daily for essential hypertension, montelukast sodium (SINGULAIR) from Oct2020 at 10mg at bedtime for Allergy and took vitamins, immunity booster and natural remedies. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient experienced herpes pain has disappeared in Jan2021 and was reported to serious due to Medically significant. The reporter considered the event herpes pain has disappeared was related to BNT162B2. Caller was reporting a positive effect with Covid-19 vaccine. She had had genital herpes virus since age 26. She had always had pain and flares. 4-5 days after receiving the first dose the pain has disappeared. She received the second dose on Tuesday 19Jan2021. She had no pain. She felt normal. She didn't get medical attention for this. She used an immunity booster and natural remedies. Caller was working at a clinic administering the vaccine to residents to a long term care facility. After the residents were vaccinated she was offered the vaccine since she is also a nurse. She went to a drive thru clinic for the second dose. The patient reported she had type 2 diabetes mellitus from 19Jan2021 (also reported it was medical history from 19Jan2021). The patient had no relevant tests. The outcome of the event herpes pain has disappeared was not recovered, the outcome of the type 2 diabetes mellitus was unknown.; Sender's Comments: The event type 2 diabetes mellitus was most likely an underlying condition and unrelated to suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/01/2021,4.0,OTH,CHLORTHALIDONE; SINGULAIR,Allergy; Essential hypertension; Genital herpes (had genital herpes virus since age 26.),,,,"['Therapeutic response unexpected', 'Type 2 diabetes mellitus']",1,PFIZER\BIONTECH, 1004611,NC,67.0,F,"chest tightness; This is a spontaneous report from a contactable physician reported for herself. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular on left deltoid on 17Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing asthma well controlled. There were no concomitant medications. The patient experienced chest tightness on 17Jan2021 with outcome of recovered on 17Jan2021. Event reported as serious with medically significant. It is reported that the patient wanted to report a side effect she had when she and her husband got their first Covid vaccine from Pfizer on 17Jan2021. She had chest tightness 15 minutes later. She asked for her husband's albuterol inhaler and was back within baseline within minutes. Stated that she used her husband's albuterol inhaler once and recovered completely. Clarified the name as Albuterol HFA 90mcg Inhaler (90mcg; one box has 200 puffs). Sender's Comments: A causal association between BNT162B2 and the reported event cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/17/2021,01/17/2021,0.0,UNK,,Asthma,,,,['Chest discomfort'],UNK,PFIZER\BIONTECH,OT 1004618,MI,87.0,F,"like she was going to pass out; Weakness; pains in the stomach/stomach was acting up; can't get to feeling herself; getting dizzy/ lightheadedness / felt dizzy/ dizziness; She didn't feel good/sick; She wakes up in the night crying; feel like she was little warm; she felt like she was going to die; pain in her stomach was like she had an ulcer; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection, lot number: EL3248), via an unspecified route of administration on 18Jan2021 at single dose in left arm for COVID-19 immunization. Medical history included leg problem, it's severe pain in the right leg in the back; very bad nerves. Concomitant medication included oxycodone hydrochloride, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for pain in her right leg. The patient had severe pain in her right leg and she was going to pain clinic for that, he was giving 'Propacet' for that. Caller stated that she had the injection on Monday (18Jan2021) at fair grounds, its the Covid Vaccine. She didn't feel good the day she got it on Monday. Then Tuesday she felt good. Wednesday (20Jan2021) she was sick again, and having pains in the stomach, well she can't say stomach, but also towards the afternoon around 2'o clock, she got light headed and dizzy, she felt like she was about to pass out (21Jan2021), and she thought to herself she had to hurry and get something to eat and that feeling last 4-5 hours. She took a pain pill when she got something to eat, and thought to sit down watch a program to take her mind off of it because she felt like she was going to die (Jan2021). After the pain pill and the food it seemed to get better. She wakes up in the night crying (Jan2021), because she was scared if she didn't get better the shot would kill her. Maybe it's her nerves getting the best of her. Her son had the vaccine and had no side effects. She wanted to know if she is the only one having the side effects. While on the phone with this call handler, caller states that she was starting to get dizzy again but she just had breakfast. Her First Dose was on 18Jan2021 Mon, and on the way home she said to her son she was getting dizzy/ lightheadedness. Her son said to her its not from the shot, but she was getting dizzy. On 19Jan2021 Tuesday, she felt good that day. On 20Jan2021 Wednesday, she was Sick again, with weakness, dizziness, she can't get to feeling herself and she had Pain in the stomach. On 21Jan2021 Thursday she felt dizzy, like she was going to pass out. On 22Jan2021 Friday she was feeling dizzy again, and her stomach was acting up and she was weak again. Caller was dizzy and weak. The dizziness was a different each time, sometimes she has got it, sometimes she didn't, its intermittent, she would be doing something and then she needed to grab a hold of something when the dizziness come on. Her Weakness was about the same. She was not feeling the stomach pain right at this minute, when she woke up during the night with it and last felt it 5 or 6AM this morning, she had chores and tasks to do this morning, but her heads going at that time also around 5 or 6 o clock, it was about the same as Wednesday, she just felt like she needed to get something to settle her stomach down, like she needed something for the energy. When attempting to get the product details, caller states that she was getting old, she provided EL3248, she needed light to read it. The card did have an Expiry date but she can't read it, it's 20 something, she just can't read. She was on nothing new. She took a pain pill when she got home but it didn't help, she was still dizzy. The pain pill was Percocet, it was dispensed in a brown pharmacy vial. Medical Conditions: She has a leg problem, it's severe pain in the right leg in the back, she wears a back brace, she needed an MRI Monday. Caller stated the date 12Feb2021, but did not confirm what this date was for. She didn't know how she would get the MRI if she didn't feel better. They were trying to pinpoint the pain in the leg. They tell her that she was in good health for 87 years of age, when they put her in back brace she felt good. On Monday when she got up there she was a little weak and they put her in a wheelchair that day, this past Monday. She had No results to share but she had a X ray a couple weeks ago (Jan2021), and that would lead up to MRI she was going to have. Caller stated that she had very bad nerves, her husband passed away 2 years ago and she hasn't overcome that, she lived by her-self, and was wondering if some of this stress, would lead to the symptoms she was having right now. She wanted to know if these are normal side effects and if it safe to have the second dose. Caller stated that she was slow and old. Consumer further stated, she didn't know if she got the right party or not. She just want to know if she was having a reaction to the COVID-19 injection (COVID-19 Vaccine) that she had on Monday, she didn't have a (distorted voice) that serious, like the whole Monday she was sick, Tuesday she felt fine, yesterday she was so stressed she can't hold her head up today she felt good but about 2 o'clock, she had pain in her stomach and she had it all the time, the pain in her stomach was like she had an ulcer and all of sudden she feel like she was little warm (Jan2021) and had to pass out and then get something to eat and sit down and take something for pain and it last about two hours and then go away and about 4 hours later she got it right back. She just wanted to know if that has anything to do with (incomplete sentence). She was not sure if she should (incomplete sentence), she was scared to have a second injection. Second due date of vaccine was 08Feb2021. The outcome of the events getting dizzy/ lightheadedness / felt dizzy/ dizziness, Weakness, pains in the stomach/stomach was acting up was not recovered, of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/01/2021,,UNK,PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL],,Medical History/Concurrent Conditions: Leg pain (it's severe pain in the right leg in the back); Nerve degeneration,,,"['Abdominal pain upper', 'Asthenia', 'Crying', 'Dizziness', 'Feeling abnormal', 'Feeling hot', 'Malaise', 'Nervousness', 'Pain in extremity', 'Sleep disorder', 'X-ray']",UNK,PFIZER\BIONTECH, 1004620,IN,55.0,F,"petechial rash around injection site and mouth; found to have platelet count of 2,000.; patient had ITP; extreme headaches; fatigue; This is a spontaneous report from a contactable pharmacist. A 55-year-old non-pregnant female patient of received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 21Jan2021 as first single dose for covid-19 immunization. Medical history included hypertension, diabetes, arthritis from unknown dates. Concomitant medication within two weeks included albuterol (salbutamol), dulaglutide (TRULICITY), escitalopram oxalate (LEXAPRO), glimepiride (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), insulin glargine (BASAGLAR), lisinopril (MANUFACTURER UNKNOWN), lorazepam (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN). The patient previously took ibuprofen (MOTRIN) and experienced allergies and drug intolerance. The patient experienced serious events, that involved hospitalization and were life threatening illness (immediate risk of death from the event) as follows: The patient experienced extreme headaches on 21Jan2021 with outcome of recovering; fatigue on 21Jan2021 with outcome of recovering; petechial rash around injection site and mouth on 25Jan2021 with outcome of recovering; patient had immune thrombocytopenia (ITP) on 21Jan2021 with outcome of recovering; found to have platelet count of 2,000 on 25Jan2021 with outcome of recovering. The patient was hospitalized for extreme headaches, fatigue, petechial rash around injection site and mouth, patient had ITP and found to have platelet count of 2,000 for five days. The events were also serious as they were considered life-threatening. The patient underwent lab tests and procedures which included platelet count 2,000 on 25Jan2021; platelet count 1,000 on 25Jan2021. Details were as follows: following the vaccine , which had been 21Jan2021 and had extreme headaches and fatigue for the next two days. On 25Jan2021, the patient developed petechial rash around injection site and mouth. Patient was seen at OSH emergency department and found to have platelet count of 2,000. Patient transferred to the reports facility on 25Jan2021 for hematology consult, and was found to have platelets of 1,000. Extensive hematology workup was completed and it was determined patient had ITP. Therapeutic measures were taken as a result of extreme headaches, fatigue, petechial rash around injection site and mouth (petechiae), patient had ITP and found to have platelet count of 2,000. Therapeutic measures included platelet transfusion, dexamethasone 40mg daily, 3 doses of IVIG. The patient was recovering from the events as aforementioned. The patient has not been COVID tested post vaccination. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event due to temporal association. However patient underlying medical conditions cannot be ruled out as contributing to the reported events",Not Reported,,Yes,Yes,5.0,Not Reported,N,01/21/2021,01/21/2021,0.0,UNK,ALBUTEROL [SALBUTAMOL]; TRULICITY; LEXAPRO; GLIMEPIRIDE; HYDROCHLOROTHIAZIDE; BASAGLAR; LISINOPRIL; LORAZEPAM; METFORMIN,,Medical History/Concurrent Conditions: Arthritis; Diabetes; Hypertension,,,"['Fatigue', 'Headache', 'Immune thrombocytopenia', 'Immunoglobulin therapy', 'Injection site rash', 'Injection site reaction', 'Oral mucosal eruption', 'Petechiae', 'Platelet count decreased', 'Platelet transfusion']",1,PFIZER\BIONTECH,OT 1004622,NY,,F,"fell down the stairs; unable to speak; unable to move her left side; Patient received COVID 19 and was not feeling well afterwards.; This is a spontaneous report from a non-contactable nurse. A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), intramuscular on 13Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. On 13Jan2021, after the vaccine, the patient was not felling well and the patient called out of work on 14Jan2021. On 16Jan2021 at 03:00, the patient fell down the stairs and was unable to speak or move her left side. She was taken by ambulance to the emergency room and admitted to neuro intensive care unit. She was treated with unspecified medications. She was in the hospital for 12 days from 16Jan2021 to 28Jan2021. From 28Jan2021, she was in rehabilitation. The clinical outcomes of the feeling unwell, fall, unable to speak, and unable to mover her left side was not recovered. The events were reported as serious for hospitalization and being life-threatening. No follow-up attempts are possible; information about lot number cannot be obtained.; Sender's Comments: On 13Jan2021, after the vaccine, the patient was not felling well. On 16Jan2021 at 03:00, the patient fell down the stairs and was unable to speak or move her left side. A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the onset of events feeling unwell, fall, unable to speak, and unable to mover left side cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,12.0,Not Reported,N,01/13/2021,01/13/2021,0.0,UNK,,,,,,"['Aphasia', 'Fall', 'Hemiplegia', 'Impaired work ability', 'Intensive care', 'Malaise', 'Movement disorder']",1,PFIZER\BIONTECH,OT 1004623,PA,67.0,F,"found collapsed and very confused; found collapsed and very confused; unresponsive; difficulty breathing; blank stare; This is spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an 28Jan2021 (at the age of 67-years-old) at a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient was found collapsed and very confused, unresponsive, and experienced difficulty breathing on 29Jan2021. The events caused hospitalization and were reported as life-threatening. The patient also experienced blank stare on 29Jan2021. The clinical course was reported as follows: The patient had a blank stare after receiving the first dose of the vaccine. The patient was later found collapsed and very confused. She was taken to the hospital, became unresponsive, and had difficulty breathing. The patient required intubation and sedation and remained in hospital. Therapeutic measures were taken as a result of found collapsed and very confused, unresponsive, and difficulty breathing as aforementioned. The clinical outcome of found collapsed and very confused, unresponsive, difficulty breathing, and blank stare was unknown.",Not Reported,,Yes,Yes,,Not Reported,U,01/28/2021,01/29/2021,1.0,PVT,,,Medical History/Concurrent Conditions: COPD,,,"['Confusional state', 'Dyspnoea', 'Endotracheal intubation', 'Sedative therapy', 'Staring', 'Syncope', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH, 1004624,MO,71.0,F,"her heart went into atrial fibrillation (AFib) and heart rate was up to 155; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunisation. Medical history included blood cholesterol abnormal, atrial fibrillation and ongoing high blood pressure.Concomitant medication included losartan for high blood pressure, atorvastatin for cholesterol, gabapentin, hydrochlorothiazide (HYDROCHLORZIDE). The patient experienced her heart went into atrial fibrillation (AFib) and heart rate was up to 155 on 20Jan2021 with outcome of unknown. The patient went to the hospital last night on 20Jan2021 and corona virus test that was negative last night.The patient stated she was still in the hospital, until 21Jan2021. (Dates of hospitalization was not available over the call, hence hospitalization was checked as seriousness criteria). The patient received a medicine that they put in the drip, IV, to lower her heart rate. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/19/2021,01/20/2021,1.0,UNK,LOSARTAN; ATORVASTATIN; GABAPENTIN; HYDROCHLORZIDE,Blood pressure high,Medical History/Concurrent Conditions: Atrial fibrillation; Blood cholesterol abnormal,,,"['Atrial fibrillation', 'Condition aggravated', 'Coronavirus test negative', 'Heart rate increased']",1,PFIZER\BIONTECH, 1004632,NC,75.0,M,"He got the first dose on 06Jan then 12Jan he tested positive; He got the first dose on 06Jan then 12Jan he tested positive; This is a spontaneous report from a Pfizer sponsored program, via a contactable consumer (patient). A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCIN, lot number: EK9231), on 06Jan2021 at single dose for covid-19 immunization. Medical history included idiopathic pulmonary fibrosis. Concomitant medication included nintedanib esilate (OFEV). patient got the first dose on 06Jan then 12Jan he tested positive and then he already scheduled for booster shot on 27Jan and he is asking if he can take that also because according to his doctor, other doctor said do not take it, the other doctor says take it. No investigation assessment. outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/12/2021,6.0,UNK,OFEV,,Medical History/Concurrent Conditions: Idiopathic pulmonary fibrosis,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1004636,TX,70.0,F,"she did not have any symptoms until Tuesday (19Jan2021)/swab her nose/it came out positive; she did not have any symptoms until Tuesday (19Jan2021)/swab her nose/it came out positive; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Jan2021 at single dose for Covid-19 immunization. Medical history included high blood pressure, acid reflux, allergy. Concomitant medication included lisinopril for high blood pressure, oxymetazoline hydrochloride (CLARITIN ALLERGIC) for allergy, cetirizine hydrochloride (ZYRTEC ALLERGY) for allergy, omeprazole magnesium (PRILOSEC) (reported as it's like Prilosec) for acid reflux. Patient received the first vaccination on the 15Jan2021 and she did not have any symptoms until Tuesday (19Jan2021), she started feeling kind of bad, she was very prone to allergies, she just thought it was back, this was her season to get sick if she had to get allergies, this was when it happened like January early February, so she went to Urgent care and she wanted a cortisone shot and she didn't think she should get a cortisone shot because it would effect the effectiveness of vaccine, so they said no and they would like to swab her nose to rule out that she didn't have COVID, and he did and it came out positive, so she wanted to get our opinion that if we thought it was a true positive or false positive. She thought she couldn't get COVID after she got the part of vaccine, and the second question she had was her second dose would be on 05Feb2021 by that she would be out of quarantine so should she plan and take the second one. Patient guess the lot number was EL0142. Th outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/19/2021,4.0,UNK,LISINOPRIL; CLARITIN ALLERGIC; ZYRTEC ALLERGY; PRILOSEC [OMEPRAZOLE MAGNESIUM],,Medical History/Concurrent Conditions: Acid reflux (oesophageal); Allergy; Blood pressure high,,,"['COVID-19', 'Feeling abnormal', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1004645,FL,,U,"Pfizer vaccine caused the death; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter claimed that Pfizer vaccine caused the death of the doctor (patient). No further details reported. No follow-up attempts are possible. Information about lot and batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pfizer vaccine caused the death",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],UNK,PFIZER\BIONTECH, 1004700,VA,66.0,M,"DVT and probable pulmonary embolus based on hypoxia Patient is physician who cares for patients in NH and ALF where there is documented COVID First dose COVID vaccine 12/20/20, second dose 1/10/20 Some shortness of breath developed about 1/10, not severe 1/30 Leg pain, fever to 101.6 abrupt onset extreme fatigue, ER eval 1.31 negative eval including neg rapid and PCR COVID tests Persistent sx led to repeat ER eval including LE dopper confirming occlusive femoral vein thromboxis; no hypoxia at rest but desat to 85% on exertion (climbing one flight of steps) Started anticoagulants 2/4/21 on home treatment; not working since 1/30/21",Not Reported,,Yes,Not Reported,,Not Reported,N,12/20/2020,01/04/2021,15.0,OTH,Iron 325 mg once daily,None,"Remote history colon cancer in 2011, treated with surgery and chemotherapy, in remission; remote hx dvt and PE 2013 possibly provoked by long car ride and b-12 deficiency; iron deficiency anemia to 10.2 gm 10/2020 with no identifiable blood loss, likely malabsorbtion relatgtd to terminal ileum resection",,None,"['Angiogram', 'Blood culture negative', 'Chest X-ray normal', 'Deep vein thrombosis', 'Dyspnoea', 'Dyspnoea exertional', 'Electrocardiogram', 'Electrocardiogram ST segment abnormal', 'Fatigue', 'Hypoxia', 'Iron deficiency anaemia', 'Occupational exposure to SARS-CoV-2', 'Pain in extremity', 'Phlebitis', 'Pulmonary embolism', 'Pyrexia', 'SARS-CoV-2 test negative', 'Thrombophlebitis', 'Ultrasound Doppler abnormal', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1004742,FL,55.0,F,Severe shoulder pain. Limited range of motion,Not Reported,,Not Reported,Not Reported,,Yes,N,01/11/2021,01/12/2021,1.0,PVT,Ibuprofen,None,None,,None,"['Arthralgia', 'Joint range of motion decreased']",2,MODERNA,IM 1004747,MA,51.0,F,shortness of breath x3days prompting ER visit on 1/4,Not Reported,,Not Reported,Yes,6.0,Not Reported,U,01/14/2021,01/14/2021,0.0,WRK,metoprolol losartan vitamin B2 nortryptiline oxybutinin asa protonix,,,,mold adhesive demerol morphine,"['Angiogram', 'Chest X-ray', 'Dyspnoea', 'Laboratory test']",1,MODERNA,IM 1004777,TN,53.0,M,"Headache the next morning after receiving vaccine that hasn?t gone away, fluid in left lung, blood clots in right lung and leg.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/18/2021,01/19/2021,1.0,PVT,"One a day men?s 50 plus multivitamin, Ashwaganda, saw palmetto, milk thistle, grape seed extract, garlic extract, gingko biloba, melatonin.",None,None,,None,"['Computerised tomogram head', 'Computerised tomogram thorax', 'Fibrin D dimer increased', 'Headache', 'Pulmonary oedema', 'Thrombosis']",2,PFIZER\BIONTECH,SYR 1004795,NY,50.0,F,"Patient had sudden warmth, tingling in upper extremities, numbness and tachycardia along with hypertension",Not Reported,,Not Reported,Yes,,Not Reported,U,02/04/2021,02/04/2021,0.0,UNK,"Pravastatin, Premarin vaginal cream",,Hyperlipidemia,,No Known,"['Feeling hot', 'Hypertension', 'Hypoaesthesia', 'Paraesthesia', 'Tachycardia']",2,MODERNA,IM 1004801,TN,58.0,M,Patient had a heart attack two days after receiving first Covid Vaccine. Doctor reports that artery was 99% blocked.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,12/26/2020,12/28/2020,2.0,PUB,"metoprolol, simvastatin",none,none,,nka,"['Coronary artery occlusion', 'Myocardial infarction']",1,MODERNA,IM 1004811,NY,62.0,F,"On 1/23/21 the patient had a single-car accident, slid off icy road into snowbank. She was seen in our ER, diagnosed w/ trauma and L4 compression fracture. She was transported to Hospital for further trauma workup. We believe she was treated and released. On 1/31/21 the patient had a headache but did not seek medical attention. In the morning of 2/1 she became unresponsive and was pronounced dead on the scene when EMS arrived. Autopsy showed a left temporal subdural hematoma.",Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/23/2021,14.0,PUB,None,unknown,None,,None,"['Autopsy', 'Bone fragmentation', 'Computerised tomogram abnormal', 'Computerised tomogram spine', 'Death', 'Headache', 'Injury', 'Road traffic accident', 'Spinal compression fracture', 'Spinal stenosis', 'Subdural haematoma', 'Unresponsive to stimuli']",1,MODERNA,IM 1004820,GA,67.0,F,"Tachycardia 180 to 200 rate approximately 36 hours post second dose of vaccine. Extremely sore arm at injection site. Pain to jaw. Lump in throat, difficult to get a deep breath. Went to ER, monitored, IV fluids given, increase BP, 170/ 72.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/01/2021,02/02/2021,1.0,PUB,"Levothyroxine, estradiol, vitamin D",,Hypothyroid,,"PCN, sulfa drugs, prozac","['Blood pressure increased', 'Cardiac function test', 'Cardiac monitoring', 'Dyspnoea', 'Echocardiogram', 'Injection site pain', 'Pain in jaw', 'Sensation of foreign body', 'Tachycardia', 'Thyroid function test']",2,MODERNA,IM 1004831,FL,65.0,M,Sudden onset worsening of Dupuytren's Contracture right hand,Not Reported,,Not Reported,Not Reported,,Yes,N,01/28/2021,02/01/2021,4.0,PVT,"Advil, simvastatin, lexapro, testosterone, Niagen, vitamines",none,none,,none,"['Condition aggravated', ""Dupuytren's contracture""]",2,MODERNA,IM 1004864,WY,72.0,M,"Patient expired. Per Emergency MD note: ""This is a 72-year-old male with what sounds like diabetes, atrial fibrillation, and hypertension who presents via EMS in cardiac arrest. It sounds like he received his Covid vaccine last week. Initially he had some mild effects from it. However over the last day or so he has felt very unwell. He apparently called his wife today and told her that he was not feeling well and so she returned home. Shortly thereafter he attempted to get up from his chair. He then collapsed and fell forward onto his face. Sounds like his wife had some difficulty rolling him over to perform CPR. When EMS arrived they found him in PEA. He received a total of 5 rounds of epinephrine. At some point they did have return of spontaneous circulation. However just prior to arriving in the emergency department they lost pulses again. The patient was intubated with an 8 oh endotracheal tube prior to arrival.""",Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/03/2021,6.0,PVT,Apixiban 5mg BID Aspirin 81mg daily Atorvastatin 40mg daily gabapentin 600mg TID Soliqua (glargine/lixisenatide) 60 units daily Lisinopril 20mg daily Metformin 1000mg BID Multivitamin 1 tab daily Pioglitazone 30mg daily,,Atrial fibrillation hypertension hyperlipidemia Type 2 diabetes Heavy drinker,,NKDA,"['Cardiac arrest', 'Death', 'Endotracheal intubation', 'Fall', 'Malaise', 'Pulse absent', 'Pulseless electrical activity', 'Resuscitation', 'Syncope']",1,PFIZER\BIONTECH,IM 1004945,,91.0,M,"Narrative: Per ER MD: ""2nd dose of covid vaccine today then went home. His family found him unresponsive and started CPR and he woke up.""",Not Reported,,Not Reported,Yes,,Not Reported,U,02/02/2021,02/02/2021,0.0,OTH,,,,,,"['Resuscitation', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 1004950,,72.0,M,"Narrative: Vaccine received 1/20/21. Pt reports feeling tired starting the following day (expected), however, blood sugars went up over 400. Went to ER for evaluation and treatment. Found to have elevated CR and markedly elevated liver enzymes (AST/ALT over 1000) which slowly improved after hospitalization, IVF, and insulin. 1/28/21 labs showed CR back to normal. ALT down to 555 AST 304. Blood sugars 200s.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/20/2021,01/23/2021,3.0,OTH,,,,,,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood creatinine increased', 'Blood glucose increased', 'Fatigue', 'Hepatic enzyme increased', 'Laboratory test abnormal']",1,PFIZER\BIONTECH, 1004952,KY,90.0,M,"Patient reported following his immunization he became short of breath, tired, weak, joint pain, headache, recommended go to emergency room, resulting Hospitalization 1/20-22/2021 dx Acute Hypoxic Respiratory Failure secondary to Acute on Chronic Diastolic Heart Failure exacerbation, currently patient remains on home oxygen",Not Reported,,Not Reported,Yes,2.0,Not Reported,,01/15/2021,01/16/2021,1.0,PVT,ACETAMINOPHEN; ARTIFICIAL TEARS; DICLOFENAC; FERROUS SULFATE; FISH OIL; METOPROLOL; OMEPRAZOLE; PAROXETINE; PREVASTATIN; ROPINIROLE; SPIRONOLACTONE; SUNSCREEN; TRIAMCINOLONE,none none,PMH: Legal blindness; Osteoarthritis of knee; History of aortic valve replacement; AF- Atrial Fibrillation; Upper gastrointestinal bleeding; Dry eyes; Obesity; Osteopenia; Aortic Valve Stenosis; Unspecified Diastolic Heart failure; Depression; Cataract; Restless Legs; Age Macular Degeneration - Dry; Abdominal Aortic aneurysm; Disc Disease; Back Pain; CAD; GLAUCOMA; Gout; Hyperlipidemia; Benign essential hypertension; AORTOCORONARY BYPASS,,LISINOPRIL-RENAL FAILURE,"['Acute left ventricular failure', 'Arthralgia', 'Asthenia', 'Blood bicarbonate normal', 'Blood gases', 'Blood pH normal', 'Chest X-ray abnormal', 'Chronic left ventricular failure', 'Condition aggravated', 'Dyspnoea', 'Echocardiogram abnormal', 'Ejection fraction abnormal', 'Ejection fraction decreased', 'Fatigue', 'Headache', 'Left ventricular hypertrophy', 'PCO2 normal', 'PO2 decreased', 'Pleural effusion', 'Pulmonary oedema', 'Respiratory failure']",1,MODERNA,IM 1004956,FL,90.0,M,Wife reported patient expired on 2/3/2021,Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,,01/06/2021,02/03/2021,28.0,PUB,,,,,,['Death'],1,MODERNA,IM 1005020,,,M,"Patient took vaccine and died two weeks later; Spontaneous report s were received from consumers via social media posts concerning an 86 year old male patient who received Moderna's COVID-19 vaccine and died. There was no medical history provided. There were no concomitant medications provided. On approximately 06 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Batch # unknown), intramuscularly for prophylaxis of COVID-19 infection. All of the social media posts reported the patients death and, according to one post, the patient took two doses of Moderna's vaccine and died two weeks later. The patient died on or before 23 Jan 2021. No additional information was provided. Very limited information regarding this event has been provided at this time. The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reporter's Comments: This case concerns a 86-year old male patient. The medical history and concomitant medication is not provided. The patient experienced Death. The event occurred approximately two weeks after receiving their second of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine. The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death",Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,N,,01/01/2021,,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No adverse event, Continue: [UNK], Comment: No reported adverse events",,,['Death'],2,MODERNA,OT 1005022,,,F,"Respiratory distress; Anxiety; Fever; Passed away; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever, respiratory distress, anxiety and passed away. The patient's medical history was not provided. Concomitant product use was not provided. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, within 24 hours of receiving the vaccine, the patient developed a fever, respiratory distress and anxiety. Treatment for the events included oxygen, morphine, and lorazepam. On the evening of 26 Dec 2020, the patient passed away. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 26 Dec 2020. The cause of death was not reported. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted events of death (unknown cause) and respiratory distress, the non-serious listed event of fever, and the non-serious unlisted event of anxiety. The events of respiratory distress, fever, and anxiety occurred within 24 hours of vaccination, while the event of death (unknown cause) occurred an unknown amount of time after vaccination. Very limited information has been provided regarding the circumstances leading to death and additional information has been requested. Based on the current available information and temporal association between the use of the product and the onset of events after vaccination, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death",Yes,12/26/2020,Not Reported,Not Reported,,Not Reported,N,,12/26/2020,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Anxiety', 'Death', 'Pyrexia', 'Respiratory distress']",1,MODERNA,OT 1005025,OH,60.0,M,fever of over 105. Low pulse ox Sent to ER. Admitted with dx pneumonia,Not Reported,,Not Reported,Yes,,Not Reported,Y,02/03/2021,02/04/2021,1.0,OTH,"Aripirazole, Budesonide, Calcium, Coreg Lasix, Depakote, Colace, Keppra, Singular, Risperdal, Trazodone, Vitamin D3, Albuterol",Had been hospitalized in January with pneumonia,Asthma osteoporosis hyperlipidemia,,"PCN, phenothiazines","['Chest X-ray abnormal', 'Heart rate decreased', 'Pneumonia', 'Pyrexia']",2,MODERNA,IM 1005049,MO,45.0,F,"Patient states that her physician advised against second dose. She states she had a severe headache for days following vaccine, she collapsed at work and was hospitalized for a few days. She also reports ongoing dizziness. All information was left in a private message sent to the health departments social media page. Further requests for information have been unsuccessful thus far.",Not Reported,,Not Reported,Yes,,Not Reported,,01/14/2021,01/22/2021,8.0,PUB,,,,,,"['Dizziness', 'Headache', 'Syncope']",1,PFIZER\BIONTECH,IM 1005130,FL,83.0,M,Report of patient expired on 2/3/2021,Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,02/03/2021,28.0,PUB,,,,,,['Death'],1,MODERNA, 1005164,,75.0,M,"unresponsive Narrative: 74yo patient with pacemaker, type 2 DM, parkinson's and history of syncopal epsisodes presented to emergency dept on Jan 24th. He was observed and discharged on Jan 26th back to the home where he continued to have cognitive decline and later passed away on 2/2/2021",Yes,02/02/2021,Yes,Yes,,Not Reported,,01/21/2021,01/24/2021,3.0,OTH,,,,,,"['Cognitive disorder', 'Death', 'Unresponsive to stimuli']",1,MODERNA,IM 1005180,NY,33.0,F,Diagnosed with myocarditis 4 days after injection. Hospitalized for 1 day.,Not Reported,,Yes,Yes,1.0,Not Reported,U,01/25/2021,01/29/2021,4.0,UNK,,,Anxiety,,Latex,"['Blood test', 'Catheterisation cardiac', 'Chest X-ray', 'Computerised tomogram', 'Echocardiogram', 'Electrocardiogram', 'Myocarditis', 'Scan with contrast']",2,MODERNA,SYR 1005217,IN,99.0,F,Nursing home called 911 for decline in condition. Patient transported to ER where she was admitted to inpatient care and expired 1/30 at 16:13,Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/28/2021,1.0,PUB,"albuteron, gabapentin, levothyroxine, loperamide, pantoprazole, potassium, pravastatin, triamterine, ventolin",,"asthma, CHF, Hypokalemia, hypothyroidism",,"Morphine, penicillin, quinidine","['Death', 'General physical health deterioration']",1,MODERNA,IM 1005239,,31.0,M,GUILLAIN BARRE,Not Reported,,Not Reported,Yes,,Not Reported,U,01/01/2017,09/15/2020,1353.0,OTH,,,,,,['Guillain-Barre syndrome'],UNK,UNKNOWN MANUFACTURER, 1005269,OH,73.0,M,"experienced elevated heart rate and blood pressure approximately 24 hours post vaccination, which prompted visit to ER. a rapid covid test was administered in the ER which had a positive result. was admitted to the hospital for fever and possible PNA",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/01/2021,02/02/2021,1.0,SEN,"ascorbic acid, clonidine, cardizem, furosemide, hydralazine, donepezil, aspirin, flomax, omeprazole, ferrous sulfate, isosbride monotrate ER",,"J96.01 ACUTE RESPIRATORY FAILURE WITH HYPOXIA F25.0 SCHIZOAFFECTIVE DISORDER, BIPOLAR TYPE U07.1 COVID-19 Z86.16 PERSONAL HISTORY OF COVID-19 J98.4 OTHER DISORDERS OF LUNG E07.9 DISORDER OF THYROID, UNSPECIFIED K76.89 OTHER SPECIFIED DISEASES OF LIVER M79.10 MYALGIA, UNSPECIFIED SITE I25.10 ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS R79.89 OTHER SPECIFIED ABNORMAL FINDINGS OF BLOOD CHEMISTRY R77.8 OTHER SPECIFIED ABNORMALITIES OF PLASMA PROTEINS E66.01 MORBID (SEVERE) OBESITY DUE TO EXCESS CALORIES I48.0 PAROXYSMAL ATRIAL FIBRILLATION A41.9 SEPSIS, UNSPECIFIED ORGANISM Z79.01 LONG TERM (CURRENT) USE OF ANTICOAGULANTS N62 HYPERTROPHY OF BREAST Z96.0 PRESENCE OF UROGENITAL IMPLANTS R06.00 DYSPNEA, UNSPECIFIED Z68.41 BODY MASS INDEX [BMI]40.0-44.9, ADULT I16.9 HYPERTENSIVE CRISIS, UNSPECIFIED D61.818 OTHER PANCYTOPENIA D72.819 DECREASED WHITE BLOOD CELL COUNT, UNSPECIFIED N20.0 CALCULUS OF KIDNEY Z86.010 PERSONAL HISTORY OF COLONIC POLYPS I48.20 CHRONIC ATRIAL FIBRILLATION, UNSPECIFIED E11.22 TYPE 2 DIABETES MELLITUS WITH DIABETIC CHRONIC KIDNEY DISEASE Z79.4 LONG TERM (CURRENT) USE OF INSULIN E11.65 TYPE 2 DIABETES MELLITUS WITH HYPERGLYCEMIA R41.82 ALTERED MENTAL STATUS, UNSPECIFIED R00.0 TACHYCARDIA, UNSPECIFIED I45.4 NONSPECIFIC INTRAVENTRICULAR BLOCK R19.5OTHER FECAL ABNORMALITIES R45.1 RESTLESSNESS AND AGITATION E87.5 HYPERKALEMIA I42.2 OTHER HYPERTROPHIC CARDIOMYOPATHY I05.1 RHEUMATIC MITRAL INSUFFICIENCY I07.1 RHEUMATIC TRICUSPID INSUFFICIENCY E86.9 VOLUME DEPLETION, UNSPECIFIED R53.81 OTHER MALAISE R13.10 DYSPHAGIA, UNSPECIFIED N18.30 CHRONIC KIDNEY DISEASE, STAGE 3 UNSPECIFIED R41.0 DISORIENTATION, UNSPECIFIED F22 DELUSIONAL DISORDERS R42 DIZZINESS AND GIDDINESS R26.2 DIFFICULTY IN WALKING, NOT ELSEWHERE CLASSIFIED M62.81 MUSCLE WEAKNESS (GENERALIZED) S63.501D UNSPECIFIED SPRAIN OF RIGHT WRIST, SUBSEQUENT ENCOUNTER R60.1 GENERALIZED EDEMA R09.02 HYPOXEMIA I50.9 HEART FAILUR.",,haloperidol,"['Blood pressure increased', 'COVID-19', 'Heart rate increased', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1005276,,75.0,M,"chills 1 day after vaccine administration; found dead by family 1/18/2021 Narrative: Per patient family report, patient said the next day after vaccination that he didn't feel well because of chills. Patient was found dead at home by his family on January 18th. He was a 74yo man with castrate resistant prostate cancer and liver and bone metastases with rising PSA, status post intravenous chemotherapy 1/7/21",Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/16/2021,1.0,OTH,,,,,,"['Chemotherapy', 'Chills', 'Death', 'Malaise', 'Metastases to bone', 'Metastases to liver', 'Prostate cancer metastatic', 'Prostatic specific antigen increased']",1,MODERNA,IM 1005278,FL,77.0,M,"Symptoms started on 2/4 SOB, nausea, diaphoretic. Pt admitted on 2/5 with STEMI with stent placement and thrombectomy",Not Reported,,Not Reported,Yes,,Not Reported,U,02/01/2021,02/04/2021,3.0,UNK,"Protonix, Gabapentin",,,,Gluten,"['Acute myocardial infarction', 'Dyspnoea', 'Hyperhidrosis', 'Nausea', 'Stent placement', 'Thrombectomy']",UNK,MODERNA, 1005290,ND,40.0,F,On Jan 1st-3rd felt so tired I couldn?t get out of bed. Slept almost 24 hours a day. Morning of Jan 3rd I had a seizure. I have no memory following the next 36 hours. Spent 3 days in the hospital. Cause as yet I know. EEG during hospital stay and again on Jan 29th showed no unusual activity. Mri and CAT showed nothing abnormal.,Not Reported,,Not Reported,Yes,3.0,Not Reported,U,12/22/2020,01/01/2021,10.0,PVT,"Clonidine, Effexor, risperdone, lorazepam, lyrica, phentermine, glimepiride, metropolol, soma, victoza, lipitor",,"Obesity, chronic fatigue syndrome, anxiety, ptsd, major depression, cervicalgia, lumbago, sciatica, arthropathry of lumbar facet joints, degenerative disc disease, type 2 diabetes, essential hypertension, suicidal ideation",,"Pennicillin, bupropion, azthromycin, estrodial, Celebrex, tramadol, trazadone, fluconazole, metformin, adhesives","['Amnesia', 'Blood glucose increased', 'Blood lactic acid increased', 'Blood magnesium decreased', 'Computerised tomogram normal', 'Drug screen negative', 'Electroencephalogram normal', 'Fatigue', 'Hypersomnia', 'Laboratory test abnormal', 'Magnetic resonance imaging normal', 'SARS-CoV-2 test negative', 'Seizure']",1,MODERNA,SYR 1005301,KY,88.0,F,"Patient tested positive for COVID-19 on 1/8/21. She demonstrated a decline in appetite and the ability to feed herself d/t this illness, but no respiratory or other symptoms. She received COVID-19 vaccine #2 on 1/26/21. She demonstrated an SDTI wound to the Lt. heel on 1/27/21. On 1/31/21 she was noted to have a significant weight loss. She was admitted to services on 2/1/21 with comfort care orders. On 2/2/21 she was observed to be without vital signs. Orders were for DNR, and CPR was not initiated in accordance with that order. She was pronounced dead at 0112 on 2/1/21.",Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,,01/26/2021,02/01/2021,6.0,SEN,Vitamin B-12,COVID-19,"Dementia, Dysphagia, HTN, Diabetes Mellitus Type 2, Hypercholesterolemia",,NKA,"['Death', 'Feeding disorder', 'SARS-CoV-2 test positive', 'Tissue injury', 'Weight decreased', 'Wound']",2,PFIZER\BIONTECH,IM 1005304,PA,35.0,F,"Began shaking and face tingling 6 minutes after shot, started to feel slightly better. 10 minutes after shot, neck became red, red welts appeared on bilateral upper arms. took 25mg of po benadryl at my desk. 25 minutes after shot felt hot, dizzy, arms and legs tingling, breathless, limbs went numb, rushed to ER via wheelchair. Treated in er for anaphylaxis. Arms and legs felt covered in ""icy hot,"" tachycardia for several hours, numerous times felt impending doom. hospitalized overnight on cardiac monitor. ER gave steroids, benadryl, pepcid, 2L ivf. ativan given later in evening for nervousness.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/03/2021,02/03/2021,0.0,PVT,fish oil daily,none,none,,mango keflex sulfa,"['Anaphylactic reaction', 'Anxiety', 'Cardiac monitoring', 'Dizziness', 'Dyspnoea', 'Erythema', 'Feeling hot', 'Feeling of body temperature change', 'Full blood count', 'Hypoaesthesia', 'Metabolic function test', 'Paraesthesia', 'Tachycardia', 'Tremor', 'Troponin', 'Urticaria', 'Wheelchair user']",2,PFIZER\BIONTECH,IM 1005326,,73.0,M,ANAPHYLAXIS,Not Reported,,Yes,Yes,,Not Reported,U,,09/08/2020,,OTH,,,,,,['Anaphylactic reaction'],UNK,UNKNOWN MANUFACTURER, 1005346,NY,,F,"Anaphylactic reaction; A spontaneous report (United States) was received from a consumer who is a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced an anaphylactic reaction. The patient's medical history included allergy to azithromycin (hives). Concomitant medications were not reported. On 09 JAN 2021, the patient received her first of two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection. On 09 JAN 2021, while sitting in the waiting area, 8 to 10 minutes after the injection, the patient experienced warm feeling, tongue getting bigger and collapsed. She was given intravenous medications and health care professionals were monitoring her vitals. The patient was transported to emergency via ambulance and was given two doses of EpiPen in the ambulance and by the time she arrived hospital she was doing better and was discharged after 4 hours. Treatment provided included EpiPen and intravenous medications. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event anaphylactic reaction was unknown.; Reporter's Comments: This case concerns a female patient of unknown age with relevant medical history of allergy to azithromycin who received her first of two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection and experienced a serious medically significant unlisted event of an anaphylactic reaction within 8-10 minutes after the injection. The reaction was described as warm feeling, tongue getting bigger and collapsed. Patient was transported to ER and given two doses of EpiPen while in the ambulance. By the time she arrived at the hospital, she was doing better and was discharged after 4 hours. Treatment also included IV medications. Based on temporal association between the use of the product and the start date of the event within 8-10 minutes after the vaccine administration, a causal relationship cannot be excluded and the event of anaphylaxis reaction is possibly related.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,UNK,,Drug allergy (hives from azithromycin),,,,"['Anaphylactic reaction', 'Feeling hot', 'Swollen tongue', 'Syncope']",1,MODERNA,OT 1005347,FL,,M,"Fainted; Unconscious; A spontaneous report was received from a consumer who was also a 73-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainting and unconscious. The patient's medical history was not provided. Concomitant medications were levofloxacin, metformin, amlodipine and lisinopril. On 21 Jan 2021, prior to obtaining his vaccination, the patient took levofloxacin, metformin, amlodipine, and lisinopril. On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2021, within minutes of receiving the vaccine, the patient fainted with his eyes open and was unconscious. His health care provider told him he was dehydrated and that might be why he fainted. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, fainting and unconscious, was considered resolved on 21 Jan 2021.; Reporter's Comments: This case concerns a 73-years-old male patient, who experienced medically significant unexpected events of Syncope and Loss of consciousness. The events occurred within minutes after first dose of mRNA-1273, lot # 012L20A. Concomitant medication included levofloxacin, metformin, amlodipine and lisinopril. Treatment details were not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded. Of note, dehydration was reported as potential contributing factor.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,UNK,LEVOFLOXACIN; AMLODIPINE; LISINOPRIL; METFORMIN,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Dehydration', 'Loss of consciousness', 'Syncope']",1,MODERNA,OT 1005350,MD,,F,"Passed out, loss of unconsciousness; Aching; Felt unwell, very sick; Shaky; Feverish; Fatigue; Nauseated; A spontaneous report was received from a 49-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of consciousness, aching, fatigue, felt unwell, very sick, shaky, feverish, and nauseated. The patient's medical history was not provided. Concomitant medication was Loratadine. On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 25 Jan 2021 prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot Number: 013L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 25 Jan 2021, after receiving the vaccine the patient experienced loss of consciousness, aching, fatigue, felt unwell, very sick, shaky, feverish, nauseated. On 29 Jan 2021, the patient was experiencing fatigue. Treatment for the event was not provided. Action taken with the mRNA-1273 was withdrawn. The outcome for the events, loss of consciousness, aching, shaky, feverish and nauseated was Unknown and the outcome for the events, fatigue, felt unwell, very sick was considered Not resolved.; Reporter's Comments: This case concerns a 49 year old female patient experienced a serious unexpected event of loss of consciousness and NS unexpected events of aching, fatigue, felt unwell, very sick, shaky, feverish and nauseated. The events occurred after first dose of the study medication administration on the same day. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/25/2021,28.0,UNK,CLARITINE,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Fatigue', 'Illness', 'Loss of consciousness', 'Malaise', 'Nausea', 'Pain', 'Pyrexia', 'Tremor']",2,MODERNA,OT 1005377,FL,80.0,M,"Significant other reported patient expired ""a week before 2nd vaccine was due"".",Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/01/2021,,PUB,,,,,,['Death'],1,MODERNA,IM 1005455,IL,78.0,M,"We don't know what happened. 25 hours after the shot, he started gagging and stopped breathing. He was pronounced at OSF at 8:07pm after we took him off life support.",Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,PVT,,"Gallbladder not working, one kidney functioning at 25%",Rheumatoid arthritis,,,"['Death', 'Respiratory arrest', 'Retching', 'Withdrawal of life support']",1,MODERNA,SYR 1005468,AZ,49.0,M,"Hospitalized with resp distress Jan1 , 2021 COVID-19 positive Severe illness, mechanical ventilation Remains hospitalized Feb 5, 2021",Not Reported,,Not Reported,Yes,36.0,Not Reported,N,12/30/2020,01/01/2021,2.0,PVT,no,Diabetes mellitus obesity,diabetes obesity,,no,"['COVID-19', 'Illness', 'Mechanical ventilation', 'Respiratory distress', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1005476,MS,60.0,F,"1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that day; blood work. Declined IV fluid. Monitored vitals. Body aches continued that weekend, went back to work the 14-15th but 'pushed it' to go back. 1/17 ER - blood panel; negative. Admitted to Inpatient to monitor heart and MRI of brain. still experiencing dizziness, 'disorientated'",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/12/2021,01/13/2021,1.0,PVT,"nortriptyline,trazadone, Vit D, Azelastine nasal spray",,Fibromyalgia (2016); allergies,,"minocycline, erythromycin","['Blood test normal', 'Cardiac monitoring', 'Chills', 'Disorientation', 'Dizziness', 'Echocardiogram', 'Magnetic resonance imaging brain', 'Pain', 'Pyrexia', 'Sleep disorder', 'Tremor', 'Vertigo']",2,PFIZER\BIONTECH,SYR 1005499,,80.0,F,"Moderna Vaccine Lot 029K20A Patient received second dose of vaccine on 2/2/21. Within 30 minutes patient had a near syncopal episode. She felt lightheaded and shortly after had episode of nonbloody vomiting. Hypotensive 81/69 and started on levophed. Alert and orientated. Lungs clear, abdomen benign on admission. Patient had no reaction when received first dose of the vaccine. Patient developed worsening shortness of breath, tachypnea, Afib with RVR, hypotension and required intubation and multiple pressors.",Yes,02/04/2021,Yes,Yes,3.0,Not Reported,N,02/02/2021,02/02/2021,0.0,PVT,Acetaminophen calcium carbonate/vitamin D3 fluoxetine ibuprofen cholecalciferol,,"depression, hearing difficulties, osteoporosis, hyperlipidemia, PVD, breast cancer in situ, hypertension, aortic aneurysm",,Adhesive tape-silicone celecoxib hydrocodone-acetaminophen pravastatin,"['Atrial fibrillation', 'Blood lactic acid', 'Dizziness', 'Dyspnoea', 'Endotracheal intubation', 'Hypotension', 'Presyncope', 'Syncope', 'Tachypnoea', 'Vomiting', 'White blood cell count normal']",2,MODERNA,IM 1005535,CA,83.0,F,"Sore arm directly after and all day. In evening, heart suddenly started pounding and beating at 85 when typical resting pulse is 60. Can and does happen from time to time for a couple heart beats. Has all my life. This time did not stop for 20 or more minutes. I took an extra propranolol and it went back to normal in a few minutes. Not positive it was result of injection but thought I should mention.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,OTH,"40 mg Propranolol, 81 mg aspirin, 5 mg Diazepam, Vit D, VitaminB complex, Famotitine",None,"Hemochromatosis, tachycardia",,"sulfa, extreme to codfish","['Condition aggravated', 'Pain in extremity', 'Palpitations']",1,MODERNA,IM 1005568,KY,66.0,M,Pt. deceased.,Yes,01/06/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,PUB,Unknown,Unknown,Unknown,,Unknown,['Death'],1,MODERNA,IM 1005585,MI,81.0,M,The morning on 2-4-2021 he was walking across the yard and started to feel light headed and dizzy. He fell injuring his right knee. He is unable to bear any weight with significant swelling that is visibly enlarging. He has decreased passive and active ROM and pain with any attempt at movement.,Not Reported,,Not Reported,Yes,,Not Reported,N,02/03/2021,02/04/2021,1.0,OTH,"Clotrimazole External Cream, Imiquimod cream, Lisinopril, Metoprolol Tart, Simvastatin, Tab-A-Vite, Tamsulosin HCL, Warfarin Sod","COVID (+) 12-16-2021, UTI 12-26-2020, epitaxies treated in ER.","HTN, hearing impairment, hyperlipidemia, cardiac arrhythmia, atrial fibrillation with long terms use of warfarin.",,"Iodine, Codeine Phosphate","['Computerised tomogram head normal', 'Computerised tomogram pelvis abnormal', 'Computerised tomogram spine', 'Dizziness', 'Fall', 'Femoral neck fracture', 'Joint injury', 'Joint instability', 'Joint range of motion decreased', 'Osteoarthritis', 'Pain', 'Soft tissue swelling', 'Weight bearing difficulty', 'X-ray limb abnormal', 'X-ray limb normal', 'X-ray of pelvis and hip abnormal']",1,MODERNA,IM 1005616,GA,41.0,M,"Stroke two days after vaccination, CVA hemorrhage, aneurysm (hospitalized ICU 08 January 2021, currently requires daily physical therapy and has walker to ambulate).",Not Reported,,Not Reported,Yes,,Not Reported,N,01/06/2021,01/08/2021,2.0,OTH,unknown,unknown,unknown,,unknown,"['Aneurysm', 'Cerebrovascular accident', 'Haemorrhagic stroke', 'Intensive care', 'Walking aid user']",1,MODERNA,IM 1005639,CA,71.0,F,"hospitalization, intermittent drooling, difficulty finding words (like a broca's aphasia), slurring of words, and absent seizure",Not Reported,,Not Reported,Yes,5.0,Yes,N,01/29/2021,01/30/2021,1.0,PVT,"Omeprazole 40 mg, meloxicam 7.5 mg, lisinopril 40 mg, Nitrostat PRN, Metformin 500 mg BID, isosorbide mononitrate 30 mg BID, prednisone 20 mg 3 tabs, carvedilol 12.5 mg BID, amlodipine 10 mg, Lantus 23 units daily, diclofenac sodium topica",UTI,"Dm, HTN, Gerd, Anxiety, breast cancer in remission (w/masectomy and lumpectomy)",,No known allergies,"['Aphasia', 'Blood test', 'Computerised tomogram', 'Culture', 'Drooling', 'Dysarthria', 'Laboratory test', 'Lumbar puncture', 'Magnetic resonance imaging', 'Petit mal epilepsy', 'Urine analysis']",1,PFIZER\BIONTECH,IM 1005663,WI,86.0,F,"Per report from family member illness started with fever, chills and increasingly progressed to needing emergency care",Not Reported,,Not Reported,Yes,,Not Reported,N,01/26/2021,01/27/2021,1.0,PUB,unknown,unknown,"CHF, unknown full health history",,none,"['Blood culture positive', 'Chills', 'Condition aggravated', 'Illness', 'Laboratory test abnormal', 'Pneumonia', 'Pyrexia', 'Sepsis']",1,PFIZER\BIONTECH,IM 1005686,KS,89.0,M,death. No known symptoms or complaints. found unresponsive in bed. Released to funeral home as the Medical Examiner will not perform and autopsy. Dr. will sign the DC.,Yes,02/04/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,SEN,"1. Jardiance 10 mg - take 1 tablet PO QAM 2. Xarelto 20 mg - take 1 tablet PO QAM 3. Metoprolol Succinate ER 25 mg - take 1 tablet PO QAM 4. Potassium Cl ER 20 mEq - take 1 tablet PO (M,W,F) 5. Gabapentin 100 mg - take 1 tablet PO QAM, 2 ta",,"CHF, HTN, HLD, pacemaker, DM, and severe osteoarthritis leading to chronic back pain and the use of a scooter for mobility.",,,"['Death', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH, 1005704,NC,82.0,F,"Pt's son called and reported that pt had COVID vaccine on 1-25-21 and was taken to the hospital via EMS due to confusion and memory loss. Pt's son states that pt was diagnosed with ""TIA"" and stayed in the hospital x 3 days. Pt states that the physicians at facility was not sure if TIA was related to vaccine but encouraged him to report adverse event. Pt's son states that pt has short term memory loss and has since moved in with him after this event happened.",Not Reported,,Not Reported,Yes,3.0,Yes,U,01/25/2021,01/26/2021,1.0,PUB,UNKNOWN,UNKNOWN,UNKNOWN,,UNKNOWN,"['Amnesia', 'Confusional state', 'Transient ischaemic attack']",1,MODERNA,IM 1005737,VA,28.0,F,"After Dose 1 - mild headache, fatigue, arm soreness for 2 days After Dose 2 - mild headache, fatigue, arm soreness for 2 days. Appendicitis resulting in appendectomy 4 days later",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/18/2021,01/22/2021,4.0,PVT,Zyrtec Multivitamin Vitamin D Fish Oil Zinc,"Miscarriage 12/7/20. Spontaneous. No procedures necessary. First dose Pfizer 12/30/20, second dose Pfizer 1/18/21.",None,,Seasonal and pet allergies,"['Appendicectomy', 'Appendicitis', 'Computerised tomogram abnormal', 'Fatigue', 'Headache', 'Laboratory test', 'Pain in extremity', 'Urine analysis']",2,PFIZER\BIONTECH,SYR 1005988,WA,40.0,F,"Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; Tenderness under eyebrow of right eye/pain behind right eye that did not go away for more than 5 days; Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; This is a spontaneous report from a contactable healthcare professional (HCP). A 40-year-old female patient received first single dose of BNT162B2 (Pfizer- BioNTech, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 14Jan2021 16:00 for COVID-19 immunization. Vaccination facility: Hospital. The patient had no relevant history. The patient was not pregnant at time of vaccination and at the time of reporting. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medication (other medications in two weeks) included multivitamin (unspecified). There was no other vaccine in four weeks. On 14Jan2021 19:00, the patient experienced shingles: approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye. Experienced pain behind right eye that did not go away for more than 5 days. Sought medical attention and ophthalmologist diagnosed shingles on 20Jan2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Treatment for the adverse events included antiviral medication and steroid drops. Patient was not Covid tested post vaccination. The patient had not recovered from the events at the time of reporting. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events herpes zoster, eyelid pain and erythema of eyelid cannot be excluded. The information available in this report is limited; information on previous occurrences of shingles, if any, would aid in case assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No,,,"['Erythema of eyelid', 'Eye pain', 'Herpes zoster', 'Ophthalmological examination abnormal', 'Tenderness']",1,PFIZER\BIONTECH, 1005990,NC,80.0,M,"irregular hearbeat; Belching; Gas; Stomach cramps; felt antsy; his blood pressure went up the day he hook the vaccine to 200/93; He was anxious feeling; sharp pains in his right eye; Ears Felt Funny; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiry date not reported), via an unspecified route of administration on 19Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included high cholesterol and blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication included propranolol hcl for blood pressure and an unspecified cholesterol pill. The patient previously received influenza (Flu shot) on an unspecified date (years) ago for immunization and experienced light headed. The patient reported that his blood pressure went up the day he hook the vaccine to 200/93 and he was real concerned about that. He took a blood pressure pill and was having some sharp pains in his right eye (he had 3-4 at different times). He was anxious feeling and could hear it blowing in his ears (which happens when his blood pressure is high). He stated he has never had his blood pressure that high and has never had any heart problems. The patient asked, whether he was in the danger zone, the danger zone of having a stroke and if they should take their second dose. The patient wondered if they could just take the first dose only. It was further reported that he took the vaccine yesterday or the day before (19Jan2021) at 11'o clock. He didn't have any problems, he just got home. Then 11'o clock at night he had fallen asleep during the day and woke up at that time, 11'o clock and he felt Antsy, his blood pressure was up, his ears puffed real high, he's on Blood Pressure medication. He Clarified further that his First Dose was on 19Jan2021 at 11 o clock during the day. Then 12 hours later that same day, he woke up, and that's when he felt antsy and the blood pressure being up. Normally he takes his Blood Pressure 2-3 times a week but that day it was like 190/80 something. When he saw it, he sat down, and thought if he relaxed it would go down. He went back over in 45 minutes or an hour later and it was 200/93, he thought he had sharp pain in the right eye during that time as well. He Never had that before, he had pain in eye before, but not like this. He then told himself maybe he should take a blood pressure pill, because he was concerned he didn't want to stroke out. He took a Blood pressure pill and then relaxed for an hour later he checked it was 189/82. He waited some more, and it kept coming down. He stayed in the recliner all night. Then on 20Jan2021 he checked and it slipped to 140/55 at about 5 o clock. The Blood pressure kept coming down 10 to 15 points every hour. The last one he took later that day was 118/65. He explains that his Blood pressure normally runs 120/65 to 140/70 normally. His blood pressure medication is only 10mg, its a low dose, he is a Healthy Person, he walks every day, his weight is good. The blood pressures provided were from 11AM to 11PM at night of 19Jan2021. It was the same day when he felt the ears feeling funny, and the sharp pain in the right eye, he has never had that before. He also forgot to mention that the next day he had a lot of stomach irregularities , he had cramping, it was uncomfortable, this was on 20Jan2021, he was also belching, and had gas. It went away that evening lasting 4-5 hours, it started in the morning 10 o clock went till 3 or 4PM. The BP value of 140/65 was from today, before lunch. The right eye sharp pain went away during the night, after he took his blood pressure pill, he didnt notice it anymore after. He doesn't know if the vaccine caused this. He couldn't tell any difference even with the pain. The ears feeling funny, he took his blood pressure a couple times a day. The monitor is showing an irregular heart beat, he didn't notice that before. He has had no positive COVID test or Antibody Test prior to the vaccine. The patient recovered from sharp pains in his right eye, ears felt funny on 19Jan2021, stomach cramps, belching, gas on 20Jan2021 while the outcome of the rest of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,UNK,PROPRANOLOL HCL,,Medical History/Concurrent Conditions: Blood pressure abnormal; High cholesterol (Verbatim: High cholesterol),,,"['Abdominal discomfort', 'Abdominal pain upper', 'Anxiety', 'Blood pressure increased', 'Condition aggravated', 'Ear discomfort', 'Eructation', 'Eye pain', 'Flatulence', 'Heart rate irregular', 'Restlessness']",1,PFIZER\BIONTECH, 1005992,VA,67.0,M,"Increased heart rate to the point where he could hear it; Oxygen level dropped to mid-eighties; Blood pressure 161/91; This is a spontaneous report from a contactable consumer (patient himself). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date not reported), via an unspecified route of administration at the left arm on 20Jan2021 14:30 at single dose for COVID-19 immunisation. Medical history included atrial fibrillation (A-fib), cryotherapy (cryoablation), blood pressure abnormal, and anticoagulant therapy (blood thinner). The patient was vaccinated at a clinic. Concomitant medications included metoprolol succinate, quinapril for blood pressure, dabigatran etexilate mesilate (PRADAXA), hydrochlorothiazide, zinc, colecalciferol (VITAMIN D [COLECALCIFEROL]), and krill oil. The patient previously took flu shot (INFLUENZA) in Nov2020 two months ago, and shingles shot (SHINGRIX) years ago and experienced sore arm. The patient reported having no problem until 18:30 when he felt an ""increased heart rate to the point where he could hear it"". He pursued saying he read his ""oxygen level at 95"" and ""pulse at 121"" with a pulse oximeter, and took his blood pressure, which was at 161/91 wilt a pulse between 128-130. He mentioned therefore going to bed and laid down, and his ""oxygen level was at 85"" and ""pulse at 136"" still using his pulse oximeter. He specified that his wife verified the pulse oximeter and after a delayed that felt like 5 minutes, she took his ""oxygen level and pulse"" which were at 95 and 72 respectively. He stated that ""all lasted 30 minutes"". As per source, ""Received first COVID-19 Vaccine. Sat for 15 minutes and didn't have any problems. Last night around 6:30PM noticed a heart rate increase rapidly to the point where he could almost hear or feel it. Pulse oximeter showed pulse was 121 and an oxygen level of 94. Talked to his wife and sat down. Took blood pressure and it was 161/91. Put on pulse oximeter. Oxygen level was dropping to mid-eighties and pulse was between 135- 136. Laid down for 10-15minutes. Tried again and his oxygen level was back to 95 and pulse was 72. Whole episode lasted about 30 minutes. Was reading paperwork and talked about rapid heart rate. Had Afib, takes medication for it and had a cryoablation about eight years ago. Feels fine today. Has not had any more episodes like that and wanted to report it. Wants to know if he should contact his doctor. Wondering will he expect this again with the second dose. Could it happen again and is there anything he can do as a safety guard? Stated he could almost hear his heart beating and was checking his pulse on his neck. His heart rate returned to 71, which is low for him. Usually his heart rate is high seventies or low eighties."" Clinical outcome of the events was recovered on 20Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/20/2021,0.0,OTH,METOPROLOL SUCCINATE; QUINAPRIL; PRADAXA; HYDROCHLOROTHIAZIDE; ZINC; VITAMIN D [COLECALCIFEROL]; KRILL OIL,,Medical History/Concurrent Conditions: AFib (A-fib); Anticoagulant therapy (Blood thinner); Blood pressure abnormal (Blood pressure); Cryoablation,,,"['Heart rate increased', 'Oxygen saturation decreased']",1,PFIZER\BIONTECH, 1005993,FL,73.0,F,"platelets dropped from 244,000 to 94,000/idiopathic thrombocytopenic purpura (ITP) for 5 years; platelets dropped from 244,000 to 94,000/idiopathic thrombocytopenic purpura (ITP) for 5 years; This is a spontaneous report from a contactable consumer (patient's spouse). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284 and expiry date: unknown), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. Medical history included high blood pressure and idiopathic thrombocytopenic purpura (ITP) for 5 years at a very severe level 4 years ago to the point she was hospitalized for 10 days and her platelets were almost count zero. Concomitant medication included amlodipine. It was reported that despite patient's condition, she has received multiple vaccines, mostly flu in the last 4 years, and had no problems. 11 days after the 1st dose, patient's platelets dropped from 244,000 to 94,000 on 18Jan2021. Patient consulted the hematologist and was prescribed with 20 mg of Prednisone. Then, after 14 days, his wife's platelets rose back up to 248,000 on 20Jan2021. Patient was scheduled to receive the 2nd dose of the vaccine a week from the time of report. Reporter to know if patient should still get the 2nd dose, and if there have been studies for people with ITP and the use of the vaccine. Patient had a rapid Covid test on Monday (18Jan2021) that came back negative and antibodies test on Monday afternoon. Outcome of the event was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/18/2021,10.0,PVT,AMLODIPINE,,Medical History/Concurrent Conditions: Idiopathic thrombocytopenic purpura (ITP for 5 years now/ IPP); Platelets decreased (4 years ago to the point she was Hospitalized for 10 days and her platelets were almost count zero),,,"['Condition aggravated', 'Full blood count', 'Immune thrombocytopenia', 'Platelet count abnormal', 'Platelet count decreased', 'Platelet count increased', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 1005995,MH,,M,"Guillain Barre syndrome; he had severe right foot drop and was taken to the ER; This is a spontaneous report from a contactable consumer and nurse. A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 08Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 18Jan2021, he had severe right foot drop and was taken to the ER, was seen by an internist and evaluated with an MRI and Xray of the spine and was scheduled for EMG and MRI of the brain at a later date. A stroke was ruled out and now wants to know if he has Guillain Barre syndrome (18Jan2021). Outcome of the events was unknown. Information about Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/18/2021,10.0,UNK,,,,,,"['Magnetic resonance imaging', 'Peroneal nerve palsy', 'Spinal X-ray']",1,PFIZER\BIONTECH, 1005996,MO,33.0,F,"increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes; increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes; This is a spontaneous report from a contactable consumer (patient sister). A 33-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration, on 30Dec2020 13:00 at single dose in right arm for covid-19 immunization. The patient medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products. It was reported that the patient had reported an increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes since the first vaccine. Lastly, she had reported that other coworkers have reported the same increase in temperature sensitivity in their extremities. No treatment was received. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['Temperature intolerance'],1,PFIZER\BIONTECH, 1005998,,,F,"she has two lung disorders, bronchiectasis and mycobacterium; she has two lung disorders, bronchiectasis and mycobacterium; a tender arm; This is a spontaneous report from a contactable consumer. This consumer reported for self that the female patient of unknown age received first dose of bnt162b2 (BNT162B2, Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. Consumer stated she has two lung disorders, bronchiectasis and mycobacterium. She then elaborated the circumstances leading to a prescription of erythromycin and a steroid, on Monday. She said she received the first dose of the COVID-19 vaccine yesterday, while being on these medications. She mentioned feeling great this morning (Jan2021), ""only a tender arm, but nothing"". She explained reading about a potential effect of steroid on the vaccine's effectiveness. She specified discussing with her HCP about it, who will follow-up with her. She asked if steroid reduces the effectiveness of the vaccine. The outcome of the events was unknown. Information on Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,['Tenderness'],1,PFIZER\BIONTECH, 1005999,AZ,,F,"She could not breath; Headache; Pain in the arm; Fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller mentioned that yesterday on an unspecified date she got the first dose of the vaccine and in the night, she had side effects to it: headache, pain in the arm, fever and she could not breath. Caller wanted to know how long the side effects of the vaccine will last. The outcome of the events was unknown. Information about Lot/batch no has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Dyspnoea', 'Headache', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH, 1006000,LA,74.0,M,"Tachycardia/ possible supra ventricular tachycardia/heart rate 209; Temp 99.9 (orally); Mild local discomfort at injection site; General fatigue; This is a spontaneous report from a contactable physician reported for himself. A 74-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 18Jan2021 13:15 at single dose for COVID-19 immunisation. There was no medical history. No allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Morning following the injection noted mild local discomfort at injection site on 19Jan2021, no other signs or symptoms. General fatigue later that day. Awakened 11:30 pm (19Jan2021) with temp 99.9 (orally). Noted tachycardia. Did limited ECG with Kardia: heart rate 209, possible supra ventricular tachycardia. Otherwise asymptomatic. Slept until 5am on 20Jan2021. Awoke asymptomatic. Afebrile, sinus rhythm, pulse 102. At 5pm 20Jan2021, afebrile, sinus rhythm, pulse 92, asymptomatic. On 21 and 22 January, asymptomatic. Sinus rhythm, pulse <100. Limited ECG 9 am on 22Jan2021 showed RSR, rate 87. Note that the patient has had NO previous history of cardiac problems, take no medications or supplements, all ECG's previously normal. No treatment received for the adverse event. Events outcome was recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event ""Tachycardia/ possible supra ventricular tachycardia/heart rate 209"" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/19/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature increased', 'Electrocardiogram abnormal', 'Fatigue', 'Injection site discomfort', 'Tachycardia']",1,PFIZER\BIONTECH, 1006002,MD,80.0,M,"Blood in stool; 36 hours after receiving his first dose of the COVID-19 Vaccine (at 4:00PM), he had massive diarrhea; This is a spontaneous report from a contactable consumer (patient). An 80-year old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 13Jan2021 07:00AM (vaccine location: Arm, Left Upper) at single dose for COVID-19 immunisation. The patient's medical history included ongoing parkinson's disease (probably had Parkinson's disease for 8 years, but was formally diagnosed 6 years ago) and peripheral neuropathy. The concomitant medications was reported as sinemet for parkinson's disease and gabapentin for peripheral neuropathy, about 6 years. Patient said 36 hours after having his first COVID-19 Vaccine dose, he had massive diarrhea on 14Jan2021 at 04:00PM. He said the diarrhea only happened one time. He said he went on a BRAT diet for a few days and then back to a regular diet. He clarified the diarrhea was brown. He said he had 1 incident of blood in his stool after that on 15Jan2021. He said he couldn't get an appointment with his doctor, so he went to emergency room. He said he was at the emergency room from 8:00AM-4:00 PM. He said the emergency room doctor told him he probably didn't have any recurrence of blood in his stool, because the blood was caused by his episode of diarrhea the day before. He said the emergency room doctor postulated that his diarrhea was caused by the COVID-19 Vaccine because there was a 36-hour delay between receiving the COVID-19 Vaccine and having diarrhea. The outcome of diarrhea was recovered on 14Jan2021. The outcome of blood in stool was recovered on 15Jan2021. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/14/2021,1.0,MIL,SINEMET; GABAPENTIN,"Parkinson's disease (probably for 8 years, but was formally diagnosed 6 years ago. sinemet for parkinson's disease)",Medical History/Concurrent Conditions: Peripheral neuropathy (gabapentin for peripheral neuropathy),,,"['Diarrhoea', 'Haematochezia']",1,PFIZER\BIONTECH, 1006003,KS,39.0,F,"severe fatigue; chills/rigors; fever; myalgia; global weakness; sweating; nausea; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 06:45 at single dose (vaccine location=right arm) for covid-19 immunisation. The patient medical history was not reported. No known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received first dose of BNT162B2 on unspecified date at single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. The patient experienced severe fatigue, chills, fever, rigors, myalgia, global weakness, sweating and nausea on 21Jan2021 07:00 PM. It was unknown if treatment received for events. Patient did not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,PVT,LEXAPRO,,,,,"['Asthenia', 'Chills', 'Fatigue', 'Hyperhidrosis', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH, 1006005,FL,,M,"seizure; This is a spontaneous report from a contactable consumer (patient's wife). A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EH9899, expiry: 31Mar2021), via an unspecified route of administration on 16Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included diabetes, cholesterol (abnormal), kidney (disorder), heart (disorder) and thyroid (disorder). Concomitant medications included insulin aspart (NOVOLOG) for diabetes, insulin glargine (LANTUS) for diabetes, atorvastatin for cholesterol, tamsulosin, valsartan (DIOVAN) for the kidneys, levothyroxine for thyroid, diltiazem for heart, metformin hcl, macrogol 3350 (MIRALAX) from 01Feb2013, aspirin [acetylsalicylic acid], vitamin D3 and cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]). It was reported that the patient had seizures between his first and second dose of the COVID vaccine on an unspecified date. He has never had a seizure in his life, and he had the Covid shot last Saturday a week ago, not yesterday but the week before (16Jan2021). The patient's wife was asking if they are suggesting that a seizure could have been an allergic reaction and if there has been any other call with someone having a seizure after having the COVID 19 vaccine. The patient was admitted in a hospital from 22Jan2021 to 23Jan2021. Friday of this week (Jan2021), they did a CT scan, blood work, and an MRI. The doctor gave him a pill, anti-seizure pill to start taking. It is Keppra low dose, one in the morning and one in the evening. The patient's wife was not stating that the seizure is caused by Pfizer, but her husband has no history or family history of seizures and is wondering if her husband should take his second shot on 06Feb2021. The outcome of the event was unknown.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/16/2021,,,UNK,NOVOLOG; LANTUS; ATORVASTATIN; TAMSULOSIN; DIOVAN; LEVOTHYROXINE; DILTIAZEM; METFORMIN HCL; MIRALAX; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN],,Medical History/Concurrent Conditions: Blood cholesterol abnormal; Diabetes; Heart disorder; Kidney disorder; Thyroid disorder,,,"['Blood test', 'Computerised tomogram', 'Magnetic resonance imaging', 'Seizure']",1,PFIZER\BIONTECH, 1006006,WI,57.0,M,"Good; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Jan2021, at 10:00 as first single dose for covid-19 immunization. Medical history included penicillin allergy. The patient's concomitant medications were not reported. The patient experienced Good on 22Jan2021, at 10:00. The event was reported as non-serious. No treatment was received for the event. The patient was not diagnosed with COVID-19 prior to vaccination, nor has he been tested for COVID-19 following vaccination. The outcome of Good was recovered in Jan2021. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Penicillin allergy,,,['Good syndrome'],1,PFIZER\BIONTECH, 1006008,CA,41.0,F,"resurgence of Covid-19 symptoms experienced the month prior; I still feel sick; congestion; sore throat; This is a spontaneous report from a contactable other HCP (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #: EK9231) on 08Jan2021 17:00 at single dose in left arm for Covid 19. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included sleep, had Covid back in Dec, early Dec. Concomitant medication within 2 weeks of vaccination included zolpidem tartrate (AMBIEN) to sleep. The patient experienced resurgence of Covid-19 symptoms experienced the month prior on 11Jan2021 12:00 AM. She had her first dose on 08Jan2021 and all of her Covid symptoms return except this time little bit worse than the first. It says 13 days since her dose and she still feel sick on 11Jan2021 12:00 AM, congestion on 9Jan2021, sore throat on 9Jan2021. No treatment received for all the events. All the events result in Doctor or other healthcare professional office/clinic visit. The patient have Covid test (Nasal Swab covid test) on 15Jan2021 but have not received the result yet. The outcome was not recovered. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient stated, ""Advil, probably 400 mg maybe like two times a day at most but it wasn't every day. I did not take it every day, I take it for couple of days.""; Sender's Comments: The 41-year-old female patient had Covid in early Dec2020. On 08Jan2021, she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), and experienced resurgence of Covid-19 symptoms on 11Jan2021. The patient have Covid test (Nasal Swab covid test) on 15Jan2021 but have not received the result yet. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the resurgence of Covid-19 symptoms most likely represents a pre-existing infection prior to vaccine use. Further information is needed for full medical assessment. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,AMBIEN,,Medical History/Concurrent Conditions: COVID-19 (Covid back in Dec); Sleepy,,,"['COVID-19', 'Malaise', 'Oropharyngeal pain', 'Respiratory tract congestion', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1006009,TX,67.0,M,"woke up with a subconjunctival hemorrhage in right eye; This is a spontaneous report from a contactable consumer reporting for himself A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262) on 23Jan2021 at 01:00 a.m. at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included diabetes. Concomitant medications included empagliflozin (JARDIANCE), lisinopril, rosuvastatin, tamsulosin hydrochloride (TAMULOSIN). On 24Jan2021 the patient woke up with a subconjunctival hemorrhage in right eye. No Treatment was given for the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/24/2021,1.0,UNK,JARDIANCE; LISINOPRIL; ROSUVASTATIN; TAMULOSIN,,Medical History/Concurrent Conditions: Diabetes,,,['Conjunctival haemorrhage'],1,PFIZER\BIONTECH, 1006011,TX,27.0,F,"Miscarriage; The mother reported she became pregnant while taking bnt162b2; The mother reported she became pregnant while taking bnt162b2; This is a spontaneous report from a contactable consumer reported for herself. A 27-year-old female patient (Pregnant) received first dose of bnt162b2 (lot number: EL3248), via an unspecified route of administration in left arm on 16Jan2021 16:30 at single dose for covid-19 immunization. Medical history included asthma, covid-19 from an unknown date and unknown if ongoing. The patient's concomitant drug included prenatal vitamins. The patient experienced miscarriage on 21Jan2021 with outcome of recovering. The event was reported as non-serious. The adverse event result in emergency room/department or urgent care. No treatment received for the adverse event. The mother reported she became pregnant while taking bnt162b2. The mother was 8 weeks pregnant at the onset of the event. The mother was due to deliver on 19Aug2021. Last menstrual date: 22Nov2020. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Not known allergies to medications, food, or other products.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/16/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Asthma; COVID-19,,,"['Abortion spontaneous', 'Exposure during pregnancy']",1,PFIZER\BIONTECH, 1006012,FL,33.0,M,"swelling of spleen and liver; swelling of spleen and liver; Fever followed by unremitting abdominal pain; Fever followed by unremitting abdominal pain; This is a spontaneous report from a contactable Other HCP. A 33-year-old male Other HCP reported that he receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL8982), intramuscular at single dose into the left arm on 18Jan2021 at 10:45 am for COVID-19 immunization. The patient had received the first dose of vaccine (Lot number ElC9231) on 28Dec2020 at 11:30 am intramuscular into the left arm. Medical history was none. Concomitant drugs were none. On 20Jan2021 the patient experienced fever followed by unremitting abdominal pain that led to hospital admission for pain management and diagnostic imaging that revealed swelling of spleen and liver. Proton pump inhibitor via IV. Opioid IV in ER. the patient was hospitalized for 3 days. Unremarkable patient history prior to this even for GI and cardio. Non smoker non alcohol user. First ever hospitalization as an adult. On 21Jan2021 the patient had a negative Nasal Swab test for covid. The outcome of the event was recovering.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events fever, abdominal pain and swelling of spleen and liver. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/18/2021,01/20/2021,2.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Abdominal pain', 'Abstains from alcohol', 'Imaging procedure abnormal', 'Liver disorder', 'Non-tobacco user', 'Pyrexia', 'SARS-CoV-2 test negative', 'Spleen disorder']",2,PFIZER\BIONTECH,OT 1006013,NY,79.0,M,"meningioencephalitis; Severe headache; severe nausea; migraine; small subarachnoid hemorrhage postulated; This is a spontaneous report from a contactable Physician (patient). A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Left arm on 07Jan2021 at 02:30 PM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included hypertension, hypercholesterolemia, hypothyroidism and dust allergy. Concomitant medications in two weeks prior to the vaccination included levothyroxine sodium (SYNTHROID), chlorthalidone and rosuvastatin calcium (CRESTOR). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 20Jan2021 at 04:00 PM patient experienced severe headache with severe nausea requiring emergency room (E R) visit and intravenous (I. V) morphine, toradol and ondansetron. Computed tomography angiography (C T A) of head performed on unknown date was normal. Pain unbearable. Lumbar puncture (L P) not done. Pain persisted four days later, though diminished. Diagnosis (Dx) uncertain but possible migraine with right (r) eye preference or small subarachnoid hemorrhage postulated. Another troublesome possibility could be vaccine reaction (meningioencephalitis). Events resulted in Emergency room/department or urgent care. Treatments received included IV morphine, zophran (as reported), ketorolac tromethamine (TORADOL) and metoclopramide hydrochloride (REGLAN). Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. Patient recovered with sequel from the reported events.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events meningoencephalitis, headache, nausea, migraine and subarachnoid hemorrhage. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/20/2021,13.0,PVT,SYNTHROID; CHLORTHALIDONE; CRESTOR,,Medical History/Concurrent Conditions: Dust allergy; Hypercholesterolemia; Hypertension; Hypothyroidism,,,"['Angiogram cerebral normal', 'Headache', 'Nausea', 'Pain']",1,PFIZER\BIONTECH, 1006015,,,F,"headache; had chills; freezing; body aches; got really hot; passed out; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Jan2021 at 13:15 at single dose for COVID-19 immunization. The patient medical history included COVID-19 from Mar2020 to an unknown date. The patient's concomitant medications were not reported. On 24Jan2021, the patient experienced at 4:00 she was freezing and had chills and body aches. At 7:15, she felt body aches and a bad headache. Things started spinning and she passed out. After that, she got really hot and she went back to bed and stayed in bed until 14:00. It seemed very severe. She didn't have a fever, but her body hurt like she did. The patient outcome of the events was unknown. The information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,01/24/2021,1.0,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Chills', 'Feeling cold', 'Feeling hot', 'Headache', 'Loss of consciousness', 'Pain', 'Vertigo']",1,PFIZER\BIONTECH, 1006016,PA,,F,"Hypothyroidism; Diabetes mellitus Type 1; Shortness of breath; Hyperlipidemia; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on left arm on 22Jan2021 01:00 at single dose for COVID-19 immunization. Medical history included known allergies to latex. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been testes for COVID-19 post vaccination. The patient experienced hypothyroidism, diabetes mellitus type 1, shortness of breath, hyperlipidemia, and had a heart surgery (triple bypass) on an unspecified date. The events resulted in visit to doctor's office or another health professional and hospitalization for 11 days. The patient received treatment for the events. The outcome of the events was recovered with sequels. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Yes,11.0,Not Reported,N,01/22/2021,,,PVT,,,Medical History/Concurrent Conditions: Latex allergy,,,"['Coronary artery bypass', 'Dyspnoea', 'Hyperlipidaemia', 'Hypothyroidism', 'Type 1 diabetes mellitus']",1,PFIZER\BIONTECH, 1006029,TX,5.0,M,"Patient had a syncopal event at night about 2 1/2 weeks after vaccination. He was found unresponsive the next morning and taken to ER, where he could not be revived.",Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,PVT,multivitamin,none,expressive language delay,,none,"['Death', 'Syncope', 'Unresponsive to stimuli']",6,SANOFI PASTEUR,IM 1006082,MI,85.0,M,"HYPOTENSION 2/4 AND 2/5, REQUIRED BUMEX REDUCTION THEN MEDICATION D/C, VERY POOR APPETITE UNABLE TO GET. REPEAT LAB WORK, RECEIVED PNEUMOCOCCAL CONJUGATE PCV-13 LOT DP5138, 1/19/2021",Not Reported,,Not Reported,Yes,2.0,Yes,U,02/02/2021,02/04/2021,2.0,SEN,"LOVENOX 80 MG BID, BUMEX 2 MG, FINASTERIDE 5 MG, LEVOTHYROXINE 50 MCG, POTASSIUM CHLORIDE 20MEQ, TAMSULOSIN 0.4, BOOST BREEZE 8 OZ BID, ELIQUIS 5MG, PROTONIX 40 MG, MILK OF MAGNESIA, LIDOCAINE CREAM PRN, TYLENOL 650 MG PRN","AFIB, GIB, COVID, PULMONARY EMBOLISM, COPD","BPH, HTN, HEART FAILURE, COLON CANCER S/P RESECTION 2019, HYPOTHYROIDISM, GIB BLEED, ESPHOGAEL VARICES,PNEUMONIA",,NKA,"['Blood chloride decreased', 'Blood chloride normal', 'Blood creatine phosphokinase increased', 'Blood creatinine normal', 'Blood potassium decreased', 'Blood sodium normal', 'Blood urea increased', 'Carbon dioxide increased', 'Decreased appetite', 'Feeding disorder', 'Haematocrit decreased', 'Haemoglobin decreased', 'Hypotension', 'Platelet count decreased', 'Red blood cell count increased', 'SARS-CoV-2 test positive', 'White blood cell count normal']",1,MODERNA,IM 1006086,VA,54.0,F,Developed rash on arms and front of legs with severe itching. She was placed on Medrol dose pack by PCP then hospitalized 1/27/21-1/29/21.,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/23/2021,01/24/2021,1.0,PVT,"Celexa, Wellbutrin, HCTZ, ASA, Zyrtec, Propranolol, Losartan",2/2020- believes she had Covid- rash developed on and off after that date,,,"PCN, Sulfa, Demerol","['Pruritus', 'Rash']",2,PFIZER\BIONTECH,IM 1006168,VA,58.0,M,"The patient, who was a pharmacist, developed fatigue and shortness of breath hours after receiving vaccine. Two days later, on 01/28/2021, the patient went to local urgent care for worsening shortness of breath and was referred to Hospital for worsening dyspnea and hypoxia. The patient was admitted to the hospital We was found to have bilateral pulmonary infiltrates and treated for pneumonia with Rocephin and azithromycin. He was tested for COVID-19 multiple times, but each of the results were negative. Despite the negative results, there was high clinical suspicion for COVID-19 and the patient was started on Remdesivir and Decadron. The patient's oxygen requirements continued to worsen and the patient was transferred to another facility for higher level of care. There his hypoxia worsened and he required mechanical ventilation. Patient then developed hypotension and required vasopressors for blood pressure support. Furthermore, patient developed acute renal failure requiring hemodialysis. Despite mechanical ventilation with FiO2 100%, and for vasopressors, patient clinically deteriorated and family decided to palliatively extubate on 02/05/2021.",Yes,02/05/2021,Not Reported,Yes,,Not Reported,N,01/26/2021,01/26/2021,0.0,PUB,,,none,,penicillin,"['Acute kidney injury', 'Dyspnoea', 'Fatigue', 'General physical health deterioration', 'Haemodialysis', 'Hypotension', 'Hypoxia', 'Lung infiltration', 'Mechanical ventilation', 'Pneumonia', 'SARS-CoV-2 test negative', 'Vasopressive therapy']",2,MODERNA,IM 1006169,MA,43.0,F,"I was approximately 4 weeks pregnant at the time that I received dose #1 (12/23/20)- I was unaware of the pregnancy. I was diagnosed with COVID on 12/28/20, but was first symptomatic on 12/24. I attributed my s/s initially to the vaccine. I was eventually tested on 12/28/20, as my symptoms worsened and I was positive for COVID. On 1/14/21 I received my second dose, my COVID s/s had been resolved since 1/4/21. On the evening of 1/18/21 I started experiencing mild abdominal pain. This progressed, on the evening 1/20 the pain was no longer tolerable. I went to the ER where I hemorrhaged and needed emergency surgery and a blood transfusion for a miscarriage. The surgery ultimately took place in the early morning hours of 1/22/21, followed by the blood transfusion.",Not Reported,,Not Reported,Yes,1.0,Yes,N,01/14/2021,01/18/2021,4.0,WRK,"Celexa, 40mg daily, Naltrexone, 50 mg daily, Cranberry supplement x1 Daily",Yes diagnosed as COVID positive on 12/24/20,no,,"Sulfa, morphine","['Abdominal pain', 'Abortion spontaneous', 'COVID-19', 'Exposure during pregnancy', 'Full blood count', 'Haemorrhage', 'Human chorionic gonadotropin positive', 'Pregnancy', 'Pregnancy test positive', 'Surgery', 'Transfusion', 'Ultrasound abdomen abnormal', 'Ultrasound scan vagina']",2,PFIZER\BIONTECH,IM 1006182,CA,87.0,M,"This patient received a Covid-19 vaccination on 1/28 at his post-acute skilled nursing facility. He began having fevers and low oxygenation the next day. He was brought to Hospital ED, tested positive for coronavirus, and was admitted to the hospital with Covid-19. I do not know what brand or lot vaccine the patient received. The SNF should have those records.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/28/2021,01/29/2021,1.0,SEN,"amlodipine, atorvastatin, citalopram, finasteride, Humalog sliding scale, pantoprazole, senna, tamsulosin",,,,penicillin,"['COVID-19', 'Oxygen saturation decreased', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1006216,SC,100.0,F,"Notes of the checks/events with resident: 18:36 2/2/21 Resident had no complaint of pain, swelling, redness or warmth to vaccine site. No signs and symptoms of fever, chills, tiredness or headache. T 97.2 02:50 2/3/2021 Resident received 2nd COVID vaccine. No complaint of pain, swelling, redness or warmth to vaccine site. No signs and symptoms of fever, chills, tiredness or headache. T 98.1 07:15 2/3/2021 Resident was observed not breathing. 911 was contacted along with the doctor. Resident was confirmed having passed away.",Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/03/2021,1.0,SEN,Medications the resident was currently recieving: AmLODIPine Besylate Tablet 5 MG Losartan Potassium Tablet 50 MG Melatonin Tablet 5 MG Povidone-Iodine Solution 10 % Remeron Tablet 15 MG (Mirtazapine) Tamsulosin HCl Capsule 0.4 MG Lactobaci,None,"ESSENTIAL (PRIMARY) HYPERTENSION ATRIOVENTRICULAR BLOCK, COMPLETE NONRHEUMATIC AORTIC (VALVE) STENOSIS WITH INSUFFICIENCY PAROXYSMAL ATRIAL FIBRILLATION HYPOXEMIA BRADYCARDIA, UNSPECIFIED PRESENCE OF UROGENITAL IMPLANTS",,No known allergies,"['Death', 'Respiratory arrest']",2,MODERNA,IM 1006220,KY,93.0,M,"Pt from home via EMS. Pt reports increased weakness since getting the covid vaccine on the 24th. Pt is normally ambulatory at baseline, but has not been able to get around his house. Pt was found to be 83% on RA and was audibly wheezing per EMS. No history of respiratory issues. Denies fever, but has had a productive cough. A&O x4. Pt received Duoneb treatment in route. Acute respiratory failure with hypoxia � , Pneumonia due to COVID-19 virus , Elevated LFTs. Patient admitted to hospital on 2/3 and is still inpatient",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/24/2021,01/31/2021,7.0,PVT,"Hime Meds: Tylenol Arthritis tablets, Lipitor, Baclofen, Celexa, Cardizem CD, Claritin-D, Myrbetriq, Remeron and Rhythmol","PMH: Former smoker, paroxysmal atrial fibrillation, sleep apnea, hypertension and osteoarthritis. Admitted to the hospital on 2/3/21 with complaints of non-productive cough for 2-3 days prior to admission and generalized weakness. His O2 sats upon admission was 83% and he was wheezing upon exam. He walks with a walker at baseline and does not use oxygen at home.","PMH: Former smoker, paroxysmal atrial fibrillation, sleep apnea, hypertension and osteoarthritis",,NKA,"['Asthenia', 'Blood creatine phosphokinase', 'Blood culture', 'Blood fibrinogen', 'Blood lactate dehydrogenase', 'Blood lactic acid', 'Blood test', 'C-reactive protein', 'COVID-19 pneumonia', 'Chest X-ray', 'Cough', 'Differential white blood cell count', 'Fibrin D dimer', 'Full blood count', 'Liver function test increased', 'Metabolic function test', 'Mobility decreased', 'N-terminal prohormone brain natriuretic peptide', 'Procalcitonin', 'Productive cough', 'Prohormone brain natriuretic peptide', 'Respiratory failure', 'Respiratory viral panel', 'Serum ferritin', 'Troponin', 'Urine analysis', 'Wheezing']",1,PFIZER\BIONTECH,IM 1006228,ND,88.0,F,"2/2/21-1000-patient presented to the local emergency room with complains of fever, shortness of breath and decreased oxygen sats. temp 101.7, pulse 102, respirations 36, BP 141/92, oxygen 94%. Lung sounds crackles bilaterally with rhonchi on the left. patient worked up for sepsis, CXR shows mild atelectasis. blood pressure dropped, and continued to drop through treatment requiring levophed drop to be initiated. Patient POA determined that this would not be her sister's wishes and made the decision to make patient comfort care status. 2/3/21- patient lethargic throughout night. 0640-patient demise.",Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/02/2021,1.0,PUB,"desmopressin 0.01% nasal spray 1 spray NS BID, dezlansoprazole 60 mg PO Daily, Escitalopram 10mg PO Daily, folic acid 1mg PO daily, furosemide 20mg PO daily, lorazepam 1mg PO TID PRN MDD 3mg in 12H, losartan potassium 100mg PO daily, macula",none known.,"atrial fibrillation, hypertension, high cholesterol, PUD, kidney stones, osteoarthritis, osteoporosis, seizure, anxiety, depression, hypothyroidism, melanoma",,"cephalosporins, codine, diazepam, morphine, penicillins, phenobarbital, sulfailamide, clindamycin","['Atelectasis', 'Blood culture', 'Blood pressure decreased', 'Chest X-ray abnormal', 'Death', 'Dyspnoea', 'Haematology test', 'Laboratory test', 'Lethargy', 'Oxygen saturation decreased', 'Pyrexia', 'Rales', 'Rhonchi', 'Urine analysis']",2,MODERNA,IM 1006261,PA,79.0,M,"Fever to 103.4, malaise,weakness; treatment tylenol supportive care, O2 to 3L",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/03/2021,02/04/2021,1.0,PVT,Prn nitro sublingual 0.4 mg Trazodone 50 mg po hs Advair 45/21 2 puffs bid Asa 81 mg qday Atorvastatin 20 mg qpm Metformin 1000 mg bid Flomax 0.8 mg qhs Proair 2 puffs q4 prn Glucosamine- chondroitin 1 tab qday unknown dose Diltiazem xr 24,Severe covid-19 with hypoxemic respiratory failure hospitalized dec 9 2020 to dec 30 2020 (two months ago),Copd Chronic hypoxemic resp failure post covid 19 Cad Htn Dm2 Ckd2,,Varencicline ?weird dreams?,"['Asthenia', 'Chest X-ray abnormal', 'Eosinophil count decreased', 'Lung opacity', 'Malaise', 'Platelet count decreased', 'Procalcitonin normal', 'Pyrexia', 'Respiratory viral panel', 'White blood cell count decreased']",2,PFIZER\BIONTECH, 1006289,GA,75.0,M,death- 2/1/2021,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/01/2021,4.0,PUB,unknown,none,HTN: Renal failure with hemodialyis; hypercholesterolemia; reflux; behavioral disorders,,none,['Death'],1,MODERNA,IM 1006296,NY,69.0,M,"fever started 12/30 after vaccine and resolved. returned around 1/3/2021 with mild cough and decreased appetite and loose stools, went to ED and tested positive for SARS-CoV-2 PCR on 1/4/2021. Received bamlanivimab on 1/9/21. Symptoms worsened with worsening SOB and went to ED on 1/11/21 and was admitted. While here received remdesivir and required max O2 4 liters on nasal cannula. Discharged on 1/20/21 on home oxygen 2Liters. 2/3/21 readmitted for complaint of 3 days of persistent SOB, headache, weakness and poor appetite.",Not Reported,,Not Reported,Yes,13.0,Not Reported,N,12/30/2020,01/11/2021,12.0,PVT,"zinc, vit c, mvi, vitamin D, ferrous sulfate, ASA 81, atorvastatin",diabetes sick sinus syndrome,diabetes sick sinus syndrome,,NKA,"['Asthenia', 'COVID-19', 'Cough', 'Decreased appetite', 'Diarrhoea', 'Dyspnoea', 'Headache', 'Oxygen therapy', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1006303,GA,67.0,M,death- 2/1/2021,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/01/2021,4.0,PUB,see nursing home record,none,CVA; HTN; vascular dementia; BPH; neurogenic bladder; COVID positive on 9/12/2020.,,none,['Death'],1,MODERNA,IM 1006316,GA,78.0,M,death- 2/2/2021,Yes,02/02/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/02/2021,5.0,PUB,see nursing home record,none,Trach; tube feeder; ileostomy; HTN; CAD; HLD; hypothyroidism; renal cell carcinoma; prostate cancer; Previously COVID positive but unkown date- it was before entering nursing home.,,none,['Death'],1,MODERNA,IM 1006416,CA,53.0,M,"Patient died of a heart attack on 1/31/21, 2.5 weeks after vaccination",Yes,01/31/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/31/2021,18.0,PVT,,,diabetes,,,"['Death', 'Myocardial infarction']",1,MODERNA,IM 1006474,NC,65.0,F,"Within 12 hrs of receiving the vaccine the pt began to experience generalized weakness, chills, shortness of breath with symptoms worsening as time went on. Pt remained afebrile. Pt presented to the ED and was diagnosed with a Pulmonary Embolism.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/01/2021,02/02/2021,1.0,MIL,"Metformin, Gabapentin, Januvia, Telmisartan/HCTZ, Eliquis, Glucotrol",None,"Type 2 Diabetes, Hypertension, Past Smoker (quit 2018)",,Mycin medications (Rash),"['Asthenia', 'Chest X-ray', 'Chills', 'Computerised tomogram', 'Dyspnoea', 'Pulmonary embolism']",1,PFIZER\BIONTECH,IM 1006485,OH,34.0,F,Had a seizure on 1/7/2021 at home - fell to floor face first and became unconscious - seizure activity two different times a few minutes apart Very nauseated and a severe headache all day prior to seizure,Not Reported,,Not Reported,Yes,2.0,Yes,Y,01/04/2021,01/07/2021,3.0,PUB,Aderal Lexipro Welbutrin - took until right after seizure,None,Psoriasis,,Leviquin Clindamycin Duricef Stelara 45mg every four weeks,"['Blood calcium decreased', 'Computerised tomogram head', 'Echocardiogram', 'Electroencephalogram normal', 'Face injury', 'Fall', 'Full blood count', 'Haemoglobin decreased', 'Headache', 'Loss of consciousness', 'Magnetic resonance imaging', 'Mean platelet volume decreased', 'Nausea', 'Seizure']",1,MODERNA,IM 1006504,NJ,42.0,M,"hives then fevers then diffuse joint pains, fatigue ongoing as of 2/5/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,PUB,None,None,History of melanoma in past,,NKDA,"['Arthralgia', 'C-reactive protein increased', 'Fatigue', 'Pyrexia', 'SARS-CoV-2 test negative', 'Urticaria', 'White blood cell count increased']",1,MODERNA,IM 1006566,NC,77.0,F,"unknown if it was moderna or pfizer. Vaccine administered elsewhere so details are not known to me. Pt received vaccine on Friday and was admitted to hospital Sunday 1/17 with CVA, right sided weakness.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/15/2021,01/17/2021,2.0,PUB,"fluoxetine 40mg 1 qd, gabapentin 300mg 2 tab tid, leflunomide 20mg 1 qd, ramipril 5mg 1 qd,",none,"HTN, Hypothryoidism, rheumatoid arthritis, NIDDM, Chronic LBP with radiculopathy",,codeine,"['Cerebral infarction', 'Cerebrovascular accident', 'Computerised tomogram head', 'Hemiparesis', 'Magnetic resonance imaging brain abnormal']",UNK,MODERNA, 1006577,,94.0,F,Patient passed away within 60 days of receiving a COVID vaccine,Yes,01/31/2021,Not Reported,Not Reported,,Not Reported,,01/04/2021,01/31/2021,27.0,UNK,,,,,,['Death'],1,MODERNA, 1006579,AR,92.0,M,"Patient received dose 1 moderna 12/29/20, and dose 2 moderna 1/25/21. Admitted to hospital for fall, altered mental status, hyperglycemia on 2/4/21.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/29/2020,02/04/2021,37.0,PVT,Gabapentin,Cellulitis of foot,Acute on chronic deconditioning h/o subdural hematomas Type 2 DM Gait instability and recurrent falls Chronic leg pain on gabapentin,,Dairy,"['Blood glucose increased', 'Fall', 'Hyperglycaemia', 'Mental status changes']",UNK,MODERNA, 1006583,,46.0,F,"During the 15 minute observation period post-vaccination, patient was noted to have hives on her neck. Patient was taken to ER. Arrival Vital Signs were WNL. Patient c/o itching, erythema, swollen tongue, changed voice, breathing ""a little tight"". Epinephrine and DuoNeb ordered. Seizure like episode at 02.04.21 at 1240 BP 209/81, HR 111, RR 24, Pulse Ox 100% on 15% Non-rebreather mask, Rectal temp 98.4 ED MD wrote: ""At approximately 12:40pm this afternoon the patient was having what appeared to be a seizure versus severe rigors. She was not verbally responsive and appeared to be apneic with her head shaking in her arms flailing rigidly in an up and down motion. Symptoms lasted approximately less than 2 minutes and patient was not postictal. She was not incontinent. Blood sugar is in the 180s and her rectal temp is normal. I believe this patient is having a severe reaction to her moderna vaccine that she received earlier today. Her 1st vaccine was January 7th and today was her 2nd vaccine for COVID."" Teleneurology consult conducted, no documented recommendations. Patient was transferred to higher level of care.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/04/2021,02/04/2021,0.0,PVT,Zyrtec 10mg oral tab 1 tab once a day citalopram 40mg oral tab 1 tab once a day amitriptyline 50mg oral tab 1 tab at bedtime losartan 50mg oral tab 1 tab once a day Symbicort 80-4.5mcg/actuation inhalation HFAA 2 puffs once a day albuterol,None,"Asthma, HTN, Depressive Disorder",,None,"['Apnoeic attack', 'Blood glucose normal', 'Blood lactic acid normal', 'Blood potassium decreased', 'Chest discomfort', 'Chills', 'Dyskinesia', 'Dysphonia', 'Dyspnoea', 'Erythema', 'Pruritus', 'Seizure like phenomena', 'Swollen tongue', 'Tremor', 'Unresponsive to stimuli', 'Urticaria', 'Vaccination complication', 'White blood cell count increased']",2,MODERNA,IM 1006633,LA,88.0,F,EARLY SUNDAY MORNING THE PATIENT BEGAN VOMITTING AND SHORT OF BREATH AND CHEST AND BACK PAIN. SHE CODED WHEN SHE GOT IN THE ER AND LATER PASSED AWAY THE MONDAY. DIAGNOSIS WAS PNEUMONIA AND HEART FAILURE PER STEP DAUGHTER.,Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,,01/20/2021,01/24/2021,4.0,UNK,,,,,,"['Back pain', 'Cardiac failure', 'Cardio-respiratory arrest', 'Chest pain', 'Death', 'Dyspnoea', 'Pneumonia', 'Vomiting']",UNK,MODERNA, 1006640,NM,45.0,F,"In discussion with Dr., medical director at Detox, she arrived night of 2/3/21 was quite intoxicated so was not going through any withdrawal. She was getting vitals and CIW checked regularly. First dose of chlordiazepoxide 25mg was 2/4 at 1:25pm for CIWA 9. She had repeat vitals at 5:50pm, CIWA 1, vitals: P 67, 118/79, 94% on RA, T 98.3. she had complained of some ""pressure in her head"" and feeling anxious, but otherwise denied other complaints. she was talking with others in the group, then other patients report she suddenly started having seizure like activity around 6:45pm, med techs came to help and found her stiff, gurgling. they tried to get vitals on her, called 911, noticed that at 6:54pm she had lost a pulse and they started CPR. paramedics arrived at 7:08pm and she was brought to ED. Pt BIBA in cardiac arrest. Pt was at Detox Center when she was reported to have seizure-like activity followed by collapse. She was found to be pulseless and CPR initiated by staff members. EMS arrived and performed approx 15 min of CPR and gave pt epi x 3 and bicarb. No shocks administered but they did not report a rhythm. In the emergency room the patient arrived and was found to be pulseless with PEA arrest, CPR was initiated, patient was intubated. ROSC ultimately achieved, patient remained very acidotic despite ventilator adjustment, head CT revealed cerebral edema. Pt also found to be profoundly anemic with a hemoglobin of 5 and platelets of 37, she was thought to be GI bleeding so medications for this were initiated. Patient then became more hypoxemic with bradycardia, consultation with neurosurgery and critical care medicine at tertiary care center deemed ongoing CPR futile. Patient arrested at 2:30AM on 2/5, pronounced dead at 2:48AM.",Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,PVT,"Naltrexone 25mg PO daily, chlordiazepoxide 25mg was 2/4 at 1:25pm for CIWA 9","Alcohol use disorder, facial laceration, alcohol intoxication, secondary syphillis",Alcohol use disorder,,NKDA,"['Acidosis', 'Anaemia', 'Analgesic drug level decreased', 'Anxiety', 'Bacterial test negative', 'Basophil percentage increased', 'Bilirubin urine', 'Blood bicarbonate decreased', 'Blood gases', 'Blood magnesium decreased', 'Blood pH decreased', 'Blood smear test', 'Blood urine absent', 'Bradycardia', 'Brain oedema', 'Cardiac arrest', 'Cardio-respiratory arrest', 'Chromaturia', 'Computerised tomogram head abnormal', 'Crystal urine absent', 'Culture urine', 'Death', 'Drug screen negative', 'Endotracheal intubation', 'Eosinophil percentage increased', 'Fibrin D dimer increased', 'Gastrointestinal haemorrhage', 'Glucose urine absent', 'Haematocrit decreased', 'Haemoglobin decreased', 'Head discomfort', 'Human chorionic gonadotropin negative', 'Hypoxia', 'International normalised ratio increased', 'Lymphocyte percentage decreased', 'Mean cell haemoglobin decreased', 'Mean cell volume decreased', 'Mechanical ventilation', 'Monocyte percentage decreased', 'Musculoskeletal stiffness', 'Neutrophil count normal', 'Nitrite urine absent', 'PCO2 normal', 'PO2 normal', 'Platelet count decreased', 'Poisoning', 'Protein urine absent', 'Prothrombin time prolonged', 'Pulse absent', 'Pulseless electrical activity', 'Red blood cell count decreased', 'Red blood cell nucleated morphology', 'Red blood cells urine positive', 'Red cell distribution width normal', 'Resuscitation', 'SARS-CoV-2 test negative', 'SARS-CoV-2 test positive', 'Seizure like phenomena', 'Specific gravity urine increased', 'Specific gravity urine normal', 'Sulphur dioxide test', 'Syncope', 'Troponin I increased', 'Urinary sediment present', 'Urine abnormality', 'Urine ketone body absent', 'Urine leukocyte esterase', 'Urobilinogen urine decreased', 'White blood cell count normal', 'White blood cells urine positive', 'pH urine normal']",1,PFIZER\BIONTECH,IM 1006641,IA,90.0,M,Had Heart Attack like symptoms - sent to Hospital,Not Reported,,Not Reported,Yes,5.0,Not Reported,U,01/30/2021,01/31/2021,1.0,SEN,Tylonal Extra Strengh Meletona Trazodone Priolsek Phyntanl Patch Laxex Atenolol Alophurinoyl Asa Synthroid Zolofot Tamsulosin,none,CHF Afib Hypo thirodism HTN Nepolasm of Prostate.,,none,['Myocardial infarction'],2,PFIZER\BIONTECH,IM 1006662,TX,51.0,F,"Pt had 2nd vaccine, went home and started having ""cramping"" in all of her muscles. It became bad enough that she was taken to local ED where she then started coughing up blood, required intubation and about 6 hrs later, died.",Yes,01/22/2021,Not Reported,Yes,,Not Reported,N,01/22/2021,01/22/2021,0.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Death', 'Endotracheal intubation', 'Haemoptysis', 'Muscle spasms']",UNK,PFIZER\BIONTECH,IM 1006667,TX,90.0,F,2 days later pt developed shortness of breath. Went to ER. Had mobitz 2 heart block and required emergency pacemaker placement,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/01/2021,02/03/2021,2.0,SEN,Long list - don?t have all details,,"Left bundle branch block, hypertension",,None,"['Atrioventricular block', 'Cardiac pacemaker insertion', 'Dyspnoea']",1,PFIZER\BIONTECH, 1006672,IA,91.0,F,Tired / confused/ slurring words/ in-content Dehydrated,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/30/2021,02/01/2021,2.0,SEN,Tylonal Extra Strength Fish Oil Vitamin C + Wild rose januvia Enalapril - hydrocholorthiazide metoprola metophorman vitamin d stool softner avervastanton,none,Type 2 Diabettes HTN,,none,"['Confusional state', 'Dehydration', 'Dysarthria', 'Fatigue']",2,PFIZER\BIONTECH,IM 1006697,VA,78.0,F,chest pain with throat irritation 1 day after receiving vaccine. no anaphylaxis. symptoms resolved.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/04/2021,02/05/2021,1.0,MIL,,,,,,"['Chest pain', 'Throat irritation']",1,PFIZER\BIONTECH,IM 1006705,NE,92.0,F,"Present to ED for chest pain, nausea, chest heaviness, mild headache and slight SOB with lower extremity swelling, Hospitalized starting today 2/5. EKG shows Afib with RVR (new oneset). Still in hospital at this time",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/02/2021,02/05/2021,3.0,PVT,"Vitamin C, Mirabegron, loratadine, methenamine, tylenol, glimeiride, vitamin d, levothyroxine, chydrochlorothiaide, valsartan, bisoprolol, zetia, aspirin, bacillus coagulans","UTI, pancytopenia","arthritis, anemia, weakness, CKD, CAD, DDD, gerd, HTN, status post cabbage, rheumatioid arthritis",,"berries, cipro, levofloxacin, macrobid, strawberries, penicillin, sulfa, nickel","['Atrial fibrillation', 'Cardiac monitoring', 'Chest discomfort', 'Chest pain', 'Dyspnoea', 'Electrocardiogram', 'Headache', 'Nausea', 'Peripheral swelling']",1,MODERNA,IM 1006707,KS,75.0,M,On January 22nd to at 9:27 a.m. He received the Pfizer Covid-19 vaccine in his right arm. By 3:00 p.m. That day he had soreness at the injection site and by 10:00 p.m. he noticed difficulty using his arms to the transfer. There was particular difficulty with the proximal left upper extremity and bracing himself and he fell to the floor. He feels that both arms are weaker since the injection. He had some pain in the arms particularly at the injection site initially but that has resolved. He had dry mouth up until February 2nd. By February 2nd he could start to transfer a bit better from a chair to his driver seat in the van. He is still not back to his baseline function.,Not Reported,,Not Reported,Not Reported,,Yes,U,01/22/2021,01/22/2021,0.0,OTH,"Aspirin, atenolol, atorvastatin, empagliflozin, multivitamin, gabapentin, Norco, losartan, omeprazole, sildenafil, Flomax, zolpidem",,"post-polio syndrome, anxiety, insomnia, paraplegia, GERD with esophagitis, Meniere's disease, scoliosis, macular degeneration, T2DM, mixed hyperlipidemia, essential hypertension",,none,"['Dry mouth', 'Fall', 'Injection site pain', 'Mobility decreased', 'Muscular weakness', 'Musculoskeletal disorder', 'Neurological examination']",1,PFIZER\BIONTECH,IM 1006745,FL,46.0,F,"12/23 first dose: 12 minutes after injection, racing heart 130 pulse for less than 2 minutes, feeling of impending doom. Repeat episodes ocurred at 1 hr post injection and 12 hrs post injection 1/19/2023 second dose: 5 minutes after injection, racing heart 130 pulse for less than 2 minutes, feeling of impending doom. Mild flu like symptoms at around 12 hrs post injection that lasted for 24 hrs. Around 48 hrs post injection, chest pain, feeling of impending doom 5-10 minutes and presented to urgent care for evaluation.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,fish oil 1000mg twice a day estradiol 1mg daily progesterone 100mg daily wellbutrin SR 150mg daily,"environmental allergies, minor symptoms of earache, congestion 2 days prior to vaccine",post menopausal environmental allergies,"influenza vaccine x 2 years in a row around age 42, 43: palpitations, dizziness, chest pain for 2-3 days following injection cau",sulfa,"['Anxiety', 'Blood thyroid stimulating hormone normal', 'Chest pain', 'Echocardiogram normal', 'Electrocardiogram ST segment abnormal', 'Electrocardiogram T wave inversion', 'Full blood count normal', 'Influenza like illness', 'Laboratory test normal', 'Lipids normal', 'Metabolic function test normal', 'Palpitations', 'Troponin normal']",2,MODERNA,IM 1006788,CA,49.0,F,"Constant and prolonged ringing in the ear/tinnitus starting a few days after the vaccine was administered. I have never experienced this constant and prolonged tinnitus before and it has continued since it first started around January 20th. I thought it would go away, but it never did. It appears I may have some hearing loss at this time now as well, which I did not previously have.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/15/2021,01/20/2021,5.0,PVT,"Magnesium 250mg and Multivitamin formula for Hair, Skin, and Nails",None,"Hemangioma, Liver",,Unknown,"['Acoustic stimulation tests abnormal', 'Deafness bilateral', 'Tinnitus']",1,MODERNA,IM 1006889,CO,98.0,F,pt admitted to hospital d/t encephalopathy,Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/30/2021,01/31/2021,1.0,PVT,"aluminum hydrox-magnesium carb; aspirin, calcium carbonate-vit d3, fish oil, fluorometholone, flucticasone, lidocane 5%, loratadine, melatonin, mirabegron, multivitamin c folic acid, naproxen sodium, polyethylene glycol packet, zoloft, sim",,dementia,,"medrol, prednisone",['Encephalopathy'],1,MODERNA,IM 1006890,AZ,41.0,F,"Within 5-10 minutes of the shot I started to get a metallic taste in my mouth. Then my legs started to feel heavy and numb, then my face felt numb and then my arms. I could barely pick something up and I could not stand. Then my jaw started to shake and so did my legs. I went to the ER and they said I was having a shock/panic attack response to the vaccine. On Monday 1/25 I woke up in extreme stomach pain and went back to the ER and they said I needed to have my appendix out. I went to a hospital where they tried to just give me antibiotics, but still had to have my appendix out on Wednesday 1/27.",Not Reported,,Not Reported,Yes,4.0,Yes,Y,01/22/2021,01/22/2021,0.0,WRK,"Trintellix, Trazadone, birth control",none,none,,codine,"['Abdominal pain upper', 'Blood test', 'Computerised tomogram', 'Dysgeusia', 'Dysstasia', 'Hypoaesthesia', 'Limb discomfort', 'Mobility decreased', 'Panic attack', 'Shock', 'Tremor', 'Trismus']",1,MODERNA,SYR 1006891,MD,58.0,F,"Syncope 5 - 10 seconds , Nausea, slight head ache, weakness after syncope 2/3 @ 10:15 am Hospitalized on 2/3 @ 11:30 am on 2/3/2021 2/5 @ 4 :30 pm Primary Care visit @ 3:30 pm on 2/5/2021",Not Reported,,Yes,Yes,1.0,Not Reported,N,01/25/2021,02/03/2021,9.0,PVT,Brio 100mcg every other day Zyrtec 10 mg 1 tme a day probiotic - 1 time a day Aleve - 1 time a day Bioclense 1 time a day Plexus 1/2 packet daily,,Asthma type incidents,,Ibuprophen simgulair Sulfa drugs,"['Asthenia', 'Blood test', 'Computerised tomogram', 'Electrocardiogram', 'Electroencephalogram', 'Headache', 'Magnetic resonance imaging', 'Nausea', 'SARS-CoV-2 test negative', 'Syncope', 'Ultrasound Doppler', 'Ultrasound scan', 'Urine analysis']",1,PFIZER\BIONTECH,IM 1006906,RI,56.0,F,"In the patient's words: ""I got the vaccine on Thursday 01/21, I was fine that day but Friday I started feeling arm pain. And chest pressure that was increasing after lunch time, SOB. Took nitro pill at around 1:30PM. Waited and took another one an hour later or so. Left 2 hrs early that days. Went home and rest. Felt a little bit better. On the weekend I felt weak, tired SOB. And pain on my shoulders. Just doing the things like making my bed in the morning. I decided to go to hospital on Monday 01/25 right after work cause I wasn?t any better. And stay over night for observation until Tuesday 26 . """,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/21/2021,01/22/2021,1.0,OTH,,,Coronary Artery Disease,,,"['Arthralgia', 'Asthenia', 'Chest discomfort', 'Dyspnoea', 'Fatigue', 'Pain in extremity']",1,MODERNA,IM 1006921,WI,87.0,M,"Began having leg weakness 4 days after the vaccine on the evening on 1/29/21. The next day the leg weakness was more significant and went to the emergency room where they found greater weakness in the left leg than the right leg. An MRI showed ""Punctate focus of diffusion restriction within the left cerebellar vermis consistent with acute infarct."" He was also found to have a critically low platelet level of 30 and then 27 while in the emergency room. He was then admitted to the hospital, placed on steroids to increase his platelet level and given physical therapy following the stroke. He was admitted to the hospital for a total of 3 nights. He was discharged home on Aspirin, Carvedilol, and Atorvastatin, has follow up with hematology to check platelets and physical therapy.",Not Reported,,Yes,Yes,4.0,Yes,N,01/25/2021,01/29/2021,4.0,PVT,"Atenolol, Plavix, Lumigan, Ocupress",None,"Hypertension, Hyperlipidemia, Coronary Artery Disease, GERD, BPH, Glaucoma",,None,"['Cerebellar infarction', 'Magnetic resonance imaging brain abnormal', 'Muscular weakness', 'Platelet count decreased']",1,PFIZER\BIONTECH,IM 1006994,WV,75.0,F,Patient had one occurrence of thrombotic thrombocytopenic purpura in 1996 for which she had plasma exchange therapy in 1996. No other occurrence since 1996 until she received her first dose of the Pfizer covid vaccine.,Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/23/2021,1.0,PVT,atorvastatin Excedrin Extra Strength gabapentin lansoprazole Lantus Solostar U-100 Insulin lisinopril Ozempic phenazopyridine Prelief Vitamin B-12 vitamin D3-vitamin K2 (MK4) zolpidem,,Diabetes Hyperlipidemia,,penicillin and sulfa,"['Computerised tomogram', 'Condition aggravated', 'Death', 'Thrombotic thrombocytopenic purpura']",1,PFIZER\BIONTECH,IM 1007033,CA,76.0,M,"Patient presented to emergency room on 2/1/2021 with a chief complaint of having a chronic headache and fatigue following receipt of the Moderna vaccine 10 days prior. Following examination by the physician, the patient was diagnosed with an acute subdural hematoma. The patient subsequently underwent decompressive surgery, however demonstrated worsening neurologic status over the next several days and ultimately expired on 2/4/2021.",Yes,02/04/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,02/01/2021,10.0,UNK,"? acetaminophen (TYLENOL) 500 mg tablet, Take 500 mg by mouth once daily as needed for mild pain (level 1-3)., Disp: , Rfl: ? amLODIPine (NORVASC) 10 mg tablet, Take 10 mg by mouth every evening. , Disp: , Rfl: ? ascorbic acid (VITAMI",History of headaches,"Memory impairment, headaches, hypertension, prostate cancer, prior stroke",,None,"['Condition aggravated', 'Death', 'Decompressive craniectomy', 'Fatigue', 'Glomerular filtration rate', 'Headache', 'Platelet count normal', 'SARS-CoV-2 test negative', 'Subdural haematoma', 'Surgery', 'White blood cell count increased']",1,MODERNA,IM 1007047,IL,36.0,F,"6 minutes after receiving vaccine patient reported that her tongue was starting to swell and that her heart was racing. Staff called 911 immediately. Pulse was 166-169, BP 125/88, O2 sat 97%. No wheezing, and the patient was moving air and talking. I had an epi-pen on hand but waited since patient was moving air and had such a high HR. After a few minutes patient reported she felt better and that her tongue was still swollen but not any more so; HR 120s, O2 sat 97%. EMTs arrived 10:39 a.m., got the same VS, and they decided not to give epinephrine. Patient was initially reluctant to be transported by ambulance and intended to have sister drive her to ED. However she reported her tongue was overlapping her teeth all the way around, and was persuaded to go by ambulance. She walked out of public health clinic into ambulance. She was treated with IV Benadryl and steroids. The ED doctor diagnosed anaphylactic reaction but also did not give epinephrine due to tachycardia. She felt better, but 4 hours afterward she did have a rebound reaction and was treated with more Benadryl and again felt better. She was discharged from the ED with 2 epi-pens. She currently feels well. States that they are having her take PO Benadryl q 4 hours x 48 hours. She was treated in the emergency department.",Not Reported,,Yes,Not Reported,,Not Reported,U,02/05/2021,02/05/2021,0.0,PUB,,,,"Moderna vaccine dose one, itching at site later in the day",bee stings,"['Anaphylactic reaction', 'Heart rate increased', 'Palpitations', 'Rebound effect', 'Swollen tongue', 'Tachycardia']",2,MODERNA,IM 1007049,AR,87.0,M,Patient was diagnosed with COVID-19 3 weeks 2 days after first dose (prior to second dose) of vaccine. He was hospitalized for 2 days secondary to mild hypoxia but has otherwise had mild course thus far.,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/06/2021,01/31/2021,25.0,PVT,"acetaminophen, albuterol inhaled, Zyrtec, vitamin D, vitamin B12, Pepcid, Namenda, Ativan, oxycodone, Miralax, Effexor, Flomax, Senna",None known,Anxiety F41.9 Benign prostate hyperplasia N40.0 Constipation K59.00 Dementia F03.90 Depression F32.9 Dysphagia R13.10 Hx of insomnia Z87.898 Macular degeneration H35.30 Psychosis F29 PTSD (post-traumatic stress disorder) F43.10 Tinea unguium B35.1,,NKDA,"['COVID-19', 'Hypoxia', 'SARS-CoV-2 test positive']",UNK,MODERNA, 1007086,FL,46.0,F,"Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we attributed to nerves and I went to go home without reporting. During the drive the headache and nausea got worse and my extremities and face began to tingle. My chest felt tight. My body was shaking. My colleague noted weak pulses and pale complexion. I am a doctor and gave myself epinephrine 0.3 mg IM and within 60 to 90 seconds the symptoms improved dramatically. I had my husband pick me up at the office and went home. The headache and nausea worsened on the drive but then settled down significantly. I rested for a few hours, then took oral pred 20 mg at about 2:45. I noticed that my headache was back and very intense at about 3:15 pm. No nausea this time, but my left eye began itching and it was very tight / hard to breathe. My extremities began tingling and I had spasms / tremors of my muscles. I injected another 0.3 mg epi into my thigh and followed with dex sodium phosphate 4 mg IM. Symptoms resolved within about 2 to 3 minutes. I took 40mg more of oral pred. I also took 10 mg of pepcid PO. I am still feeling well now with no headaches or other symptoms at this writing (7:30 pm), but I have another doctor with me and we are 2 minutes from the ER if needed. I am marking unknown below since it has only been a few hours without symptoms.",Not Reported,,Yes,Not Reported,,Not Reported,U,02/05/2021,02/05/2021,0.0,OTH,"Ondansetron 8 mg at 7:30 am Vit D, A, Zinc","None A little nauseous this am, not sure why, but no other GI signs and ate breakfast / drank tea",Sjogrens,,"Sulfa drugs Shellfish Tree nuts - pecan, brazil, macadamia","['Chest discomfort', 'Dyspnoea', 'Eye pruritus', 'Eye swelling', 'Headache', 'Muscle spasms', 'Nausea', 'Nervousness', 'Pallor', 'Paraesthesia', 'Pulse abnormal', 'Tremor', 'Vomiting']",1,PFIZER\BIONTECH,IM 1007110,MO,27.0,M,"body aches, chills, feeling sluggish, couldn't sit up, wasn't hungry or thirsty",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/02/2021,02/02/2021,0.0,SEN,,,,,,"['Chills', 'Decreased appetite', 'Fluid intake reduced', 'Pain', 'Posture abnormal', 'Sluggishness', 'Thirst decreased']",1,MODERNA,IM 1007244,CA,67.0,F,"I was hospitalized with a severe reaction to my first dose of the Pfizer vaccine given 2/1/21 @ 9:45. I was discharged Tuesday evening 2/2/21. Dr., my internist, agrees that what happened was not a vasovagal syncope (hospital?s diagnosis). My Experience: Within say 7 minutes of the injection I felt woozy, the wooziness intensified, I got intense pins and needles in my lower legs, fore arms and hands, and less so in my face. My speech became very slowed down, slurred and I had a lot of difficulty forming words. It was as if I was extremely drunk. After they called the paramedics, I was not able to get myself out of my car or walk. I lost motor coordination/control in hands and feet. I was cold, never felt faint, and had slightly evaluated blood pressure for me( normal is 110/64 paramedics got it at 152/94).",Not Reported,,Not Reported,Yes,2.0,Yes,N,02/01/2021,02/01/2021,0.0,OTH,"Gabapentin 600-900 mg Divided dose, p.m. Alprazolam 0.25mg 1 x night Valacyclovir 1g 3x day for 7 days for flare-ups Amitriptyline 10mg 2x day Elmiron 100mg 3x day Tamsulosin 0.4 mg 1x day Myrbetriq",Seasonal allergies; transverse myelitis; cardiovascular disease; interstitial cystitis; IBS; hypothryroidism,Transverse myelitis,,Cymbalta Tecfidera Plegridy Avonex Gilenya,"['Arteriogram carotid normal', 'Blood pressure increased', 'Blood test normal', 'Chest X-ray normal', 'Computerised tomogram head normal', 'Coordination abnormal', 'Dizziness', 'Dysarthria', 'Echocardiogram normal', 'Electrocardiogram normal', 'Feeling cold', 'Feeling drunk', 'Gait inability', 'Magnetic resonance imaging brain normal', 'Paraesthesia', 'Slow speech', 'Speech disorder', 'Vaccination complication']",UNK,PFIZER\BIONTECH,IM 1007310,PA,78.0,F,"view 2/5/2021 09:23 e Progress Note Note Text: Patient passed away in the facility this morning. view 2/5/2021 08:39 Orders - Administration Note Note Text: Resident passed. view 2/5/2021 08:33 Nurses Note Note Text: Body released to funeral home at this time. Personal effects sent with resident include: 1 pair of glasses, 1 yellow wedding band, 1silver spoon ring, 1 ring with black and clear stones. Resident has own teeth view 2/5/2021 08:32 Nurses Note Note Text: cause of death per CRNP failure to thrive. view 2/5/2021 07:44 Orders - Administration Note Note Text: Take and document temp & PO2 every 4 hours for MONITORING Resident passed. view 2/5/2021 06:49 Nurses Note Note Text: Son returned call and was updated of resident's passing this am view 2/5/2021 06:33 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger PRN Administration was: Unknown Resident expired @ 0604 [linked] view 2/5/2021 06:06 Nurses Note Note Text: Res found without pulse or respirations. Pronounced at 0604. Updated. N/o's for RN to pronounce, release body to funeral home, dispose of medications per facility policy. Daughter updated. Funeral Home called to release body. view 2/5/2021 05:26 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger Pulse ox 60% on O2 @ 5L/min via mask. Resps 44 per minute. view 2/5/2021 01:57 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger PRN Administration was: Effective Follow-up Pain Scale was: 2 [linked] view 2/5/2021 00:52 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger Residents resps are 40 per minute, pulse ox 76% on O2 @ 5L/min via mask. Resps are labored, shallow and rapid. view 2/5/2021 00:48 Nurses Note Note Text: Nonresponsive to verbal and tactile stimulation. Appears comfortable. view 2/4/2021 22:01 Nurses Note Note Text: Resident resting comfortably, breathing becoming increasingly shallow, wearing O2 via mask at 5L via mask, no dyspnea noted, feet are mottled, oral and peri care provided Q2H. No s/s of pain or discomfort. view 2/4/2021 21:40 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger PRN Administration was: Effective [linked] view 2/4/2021 19:32 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger medicated for air hunger, RR 28 to 32/ min view 2/4/2021 19:22 Nurses Note Note Text: Daughter updated on N/O to increase Morphine Sulfate 20mg/mL 0.25mL to Q2H prn from Q6H prn. view 2/4/2021 18:06 Nurses Note Note Text: POA Daughter and daughter aware of residents current condition. view 2/4/2021 11:58 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB PRN Administration was: Effective Follow-up Pain Scale was: 2 [linked] view 2/4/2021 11:13 Nurses Note Note Text: Pt. noted to be lethargic at this time. Does respond to verbal and tactile stimuli by opening her eyes but non verbal currently. Skin warm and dry. No mottling or apnea observed at this time. O2 sat 88% with O2 at 2 LPM via n/c. On increased to 3 LPM via mask as pt. noted to be mouth breathing. Respirations 28. F/U O2 sat 93%. HOB elevated. Pt. medicated with morphine by LPN. Daughter updated on pt.'s condition. Does not want pt. sent out to hospital and would like comfort measures to continue. Daughter also in agreement with delay in d/c d/t pt.'s condition.CRNP updated on pt.'s condition, delay in d/c and daughter's wishes. No n/o's at this time. view 2/4/2021 10:56 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB Resident showing s/s of discomfort. SOB at this time and high respirations. Repositioned, changed for incontinence care and mouth care provided. view 2/4/2021 10:34 Progress Note Note Text: Spoke with RN regarding change in condition. Updated Sr Living regarding change. Recommendation to cancel d/c/transfer for today, see how resident does through the weekend and re-evaluate on Monday. Daughter updated on cancellation of d/c today. view 2/4/2021 10:04 Nurses Note Note Text: Daughter aware that resident's O2 sat was 88% on room air on 3-11 shift and that oxygen was applied via nasal cannula. view 2/4/2021 10:03 Nurses Note Note Text: N/O: Discharge 2/4/21 with scripts to Sr. Living. Daughter aware. view 2/4/2021 09:53 Nurses Note Note Text: Pt. to be d/c'd to another facility this am as per MD order. Pt. alert and responsive. Skin assessment done as per facility policy. No pressure areas noted at this time. No s/sx of pain or discomfort observed at this time. V.S. 97.0 67 20 O2 sat 95% with O2 at 2 LPM via n/c. view 2/4/2021 07:45 Nurses Note Note Text: Resident seen by Dr. for discharge. Orders pending at this time. view 2/4/2021 07:36 Nurses Note Note Text: CRNP and Dr. updated on O2 sat 88% on RA with f/u of 93% with O2 on at 2 LPM as well as rest of VS, 3-11 shift 2/3/21. No n/o's at this time. view 2/3/2021 21:17 Nurses Note Note Text: Resident Sp02 88% on RA. Pulse 124. Respirations 40. PRN morphine given and O2 applied via NC at 2L/min. After recheck pulse ox up to 93%, pulse 100, and respirations 22. Resident appears comfortable at this time. view 2/3/2021 20:05 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB PRN Administration was: Effective [linked] view 2/3/2021 19:48 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB PRN given for SOB after elevation of HOB not effective. view 2/3/2021 11:51 Nurses Note Note Text: CRNP updated rapid COVID test done for d/c tomorrow was negative. No n/o's at this time. view 2/3/2021 11:44 Nurses Note Note Text: Daughter notified of rapid covid swab being negative. view 2/3/2021 09:50 Orders - Administration Note Note Text: Obtain Rapid Covid test on 2/3/2021 for discharge. Please give copy of results to Social Worker every day shift for covid testing for 1 Day Completed and negative. view 2/3/2021 08:45 Skilled Nursing Note Reason for skilled service: Therapy describe skilled service: Nursing, therapy assessment: V.S. 97.8 79 18 138/84 Orientation: Oriented to self only. Oxygen: O2 sat 94% on RA Edema: Trace edema noted BLE. Pedal pulses present. Pain: Denies pain or discomfort at this time. Nursing note: Pt. alert and responsive. Skin warm and dry. Lung sounds diminished. No respiratory distress observed at this time. Abdomen soft. BS+ in all 4 quads. Continent/Incontinent of B&B. 1 assist with ambulation, transfers. 1 assist with ADL's. Working with therapy on gait training, therapeutic exercise, therapeutic activities & neuromuscular reeducation. view 2/2/2021 14:37 Progress Note Note Text: Per health professional at Sr Living, prepared to accept patient to their Memory Care Unit 2/4. Transportation arranged for 11 AM per family request. Daughter (POA) updated on d/c time on 2/4/21. Facility requesting rapid COVID test completed prior to d/c and results sent to them. All other information sent for continuity of care.",Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/03/2021,1.0,SEN,"Morphine, lorazepam","ALTERED MENTAL STATUS, UNSPECIFIED CARDIAC ARREST, CAUSE UNSPECIFIED UNSPECIFIED DEMENTIA WITH BEHAVIORAL DISTURBANCE ESSENTIAL (PRIMARY) HYPERTENSION HYPERLIPIDEMIA, UNSPECIFIED ANEMIA, UNSPECIFIED PERIPHERAL VASCULAR DISEASE, UNSPECIFIED COVID-19 Resolved 1-1-21 AGE-RELATED COGNITIVE DECLINE CHRONIC ATRIAL FIBRILLATION, UNSPECIFIED ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY UTI","ALTERED MENTAL STATUS, UNSPECIFIED CARDIAC ARREST, CAUSE UNSPECIFIED UNSPECIFIED DEMENTIA WITH BEHAVIORAL DISTURBANCE ESSENTIAL (PRIMARY) HYPERTENSION HYPERLIPIDEMIA, UNSPECIFIED ANEMIA, UNSPECIFIED PERIPHERAL VASCULAR DISEASE, UNSPECIFIED COVID-19 AGE-RELATED COGNITIVE DECLINE CHRONIC ATRIAL FIBRILLATION, UNSPECIFIED ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY UTI",,none,"['Death', 'Dry skin', 'Dyspnoea', 'Failure to thrive', 'Hypopnoea', 'Lethargy', 'Mouth breathing', 'Pain', 'SARS-CoV-2 test negative', 'Skin warm', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 1007314,NM,77.0,F,"Altered mental status, fever 102.7. Left sided weakness report. I did not see this on my h and p",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/04/2021,02/05/2021,1.0,OTH,,A fib DM OA thyroid disease,See above,,Morphine pcn asa cephasporins nsaids,"['Computerised tomogram head normal', 'Hemiparesis', 'Mental status changes', 'Pyrexia']",2,MODERNA,IM 1007315,AZ,84.0,M,Excessively tired during the week after the first vaccine. One week after an undiagnosed episodic atrial fibrillation was discovered when treating a stroke. Causation not researched.,Not Reported,,Not Reported,Yes,8.0,Yes,N,01/22/2021,01/28/2021,6.0,PVT,"Rosuvastatin 40mg, Carvedilol, baby Aspirin",None,Stents in heart,,None,"['Atrial fibrillation', 'Cerebrovascular accident', 'Fatigue']",1,PFIZER\BIONTECH,SYR 1007357,MD,69.0,F,"I had a possible reaction on my Left arm and chest. My Right arm received the injection. I never have any sticks in my left arm since I have developed Lymphedema post breast cancer mastectomies and treatment in April 2006. When I arose my effected arm was red in color, with a rash on top of that. It was hot to the touch and swollen and stiff. My husband took me to the emergency room of the hospital named in Item 21 and later that day I was admitted to the hospital. They diagnosed it as a severe infection, resulting in cellulitis and started me on round the clock IV antibiotics.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/30/2021,01/31/2021,1.0,OTH,"Metformin,Venaflexine, Bupropion, Synthroid, Losartan, and Singulaire, Onglyza, Crestor, OTC .81 mg aspirin and nitrofurantoin",,"Diabetes,high cholesterol,depression, lymphadem",,"penicillin,latex","['Blood test', 'Cellulitis', 'Erythema', 'Infection', 'Musculoskeletal stiffness', 'Peripheral swelling', 'Rash', 'Skin warm']",1,MODERNA,IM 1007371,CA,62.0,F,"Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible flu. I'm wearing diapers because of uncontrollable diarrhea. I can't leave my sofa to walk over to my desk because I'll be so out of breath. I have a cough that produces a pink or gold Phelm I have dry mouth. I have no appetite I'm so weak and have lost 15 pounds. Don't know what to do. My next Covid is shot is feb 11 Called employer on 2/3/21 but hung up. Tried calling multiple times to follow up. In triage she stated she had a COVID test scheduled and had spoken with her PCP. COVID test through PCP: 2/4/21 She passed away the night of 2/4/21",Yes,02/04/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/29/2021,10.0,WRK,No current outpatient medications on file.,None known,Transplant patient.,,Not on File,"['Asthenia', 'Cough', 'Death', 'Decreased appetite', 'Diarrhoea', 'Dry mouth', 'Dyspnoea exertional', 'Gait disturbance', 'Influenza', 'Productive cough', 'SARS-CoV-2 test', 'Sputum discoloured', 'Weight decreased']",1,PFIZER\BIONTECH,IM 1007389,FL,75.0,F,"After 10 days, I developed itching and several large red welts on my right arm at injection sight. Took Benedryl pills & used cream for 3 days until it cleared up. After my second vaccination on 2/2/2021 developed redness & itching again on my left arm at site. Still using Benedryl now.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/16/2021,11.0,OTH,"Losartan, atorvastatin, levothyroxin,progesterone, Vit. B-12, calcium, Vit. D, Co Q10, magnesium, probiotics Preservision Areds 2...Montelukast",None,,,"Sulfa, Avalox","['Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Urticaria']",1,MODERNA, 1011771,,84.0,F,"Narrative: Patient with history advanced vascular dementia, hypertensive cerebrovascular disease and stroke, T2DM. Received her second dose of Pfizer COVID-19 vaccine at approximately 14:00 and was reported to have expired at home at 20:55. Dr. (Medical Director) spoke with patient's son/caregiver 2/4/21. Son reports that patient was in her usual health yesterday morning, deemed well enough by son to travel for vaccination. He reports she had no bothersome symptoms after either first or second vaccinations. Specifically denied rash, wheeze, and difficulty breathing. Son was with patient throughout the day. In the evening, when preparing for bed, he noted she became suddenly unresponsive in a similar fashion as she has done several times in past years. While in all previous such episodes she recovered within minutes, last evening she did not regain consciousness, experiences a brief period of labored breathing, and died. Patient's son called 911 and the patient's body was brought to the medical examiners. The medical examiner declined to proceed with autopsy. Patient's son is not interested in autopsy. Patient's son reports confidence that his mother's underlying hypertensive/diabetic cardiovascular disease is the natural cause of her death. Other Relevant Hx: Symptoms: & Death Treatment:",Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,,02/03/2021,02/03/2021,0.0,OTH,,,,,,"['Cerebrovascular accident', 'Death', 'Dyspnoea', 'Hypertensive cerebrovascular disease', 'Loss of consciousness', 'Type 2 diabetes mellitus', 'Unresponsive to stimuli', 'Vascular dementia']",UNK,PFIZER\BIONTECH, 1011807,,93.0,M,"general malaise , Fatigue, poor interest in activities , hypoactivity, pulmonary embolism Narrative: Patient transferred to ER for evaluation. Physician at facility reported marked deterioration, hypoactivity and slow mentation s/p COVID vaccine second dose 1/8/21. Cough also reported x 1 week. Patient evaluated at ER on 1/20/21 and admitted to internal medicine ward with diagnosis impression pulmonary emboli, aspiration pneumonia and urinary tract infection.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/08/2021,01/11/2021,3.0,OTH,,,,,,"['Cough', 'Decreased activity', 'Fatigue', 'General physical health deterioration', 'Malaise', 'Mental impairment', 'Pneumonia aspiration', 'Pulmonary embolism', 'Urinary tract infection']",1,PFIZER\BIONTECH,IM 1011983,FL,77.0,M,"Narrative: See ""Other Relevant History"" in Section 6 above Other Relevant Hx: 76yo man with a history of for C5 tetraplegia 2/2 cervical stenosis leading to neurogenic bowel/bladder (chronic suprapubic catheter) and chronic respiratory failure with tracheostomy, severe dysphagia s/p G tube placement and multiple aspiration pneumonias, COPD GOLD III, hx MRSA bacteremia (7/2018) and E coli bacteremia (12/2019). Patient transferred from Spinal Cord Injury until to ICU on 1/11/2021 due to worsneing dyspnea, hypoxia (80s) and tachycardia and was found to have acute hypoxic respiratory failure likely 2/2 multifocal pneumonia. CXR findings of ""There is interval increase in patchy airspace infiltrates and consolidation in bilateral lungs concerning for pneumonia"" Patient was started on vancomycin and pip/tazo on 1/11 and tracheal aspirate cultures were obtained for VAP diagnosis which ultimately grew Serratia liquifaciens and Proteus mirabilis. Infectious Diseases was consulted who recommended a switch to ertapenem therapy for a total 10 day course for VAP. UCx/BCx remained negative. On 1/20, a therapeutic bronchoscopy was completed with cultures growing Stenotrophomonas maltophilia and pan-S Klebsiella pneumoniae. The following day a chest tube was inserted and the course of ertapenem completed but vancomycin was continued. By 1/22, patient developed shock liver with ALT/AST 2135/1579 from normal range the day prior and SCr increased to 1.3 from baseline 0.7/cystatin C of 2.46 up from 1.15. Levofloxacin was added for Stenotrophomonas coverage. By 1/25, patient's clinical status continued to decline and Cardiology was consulted for new onset Afib with RVR. Discussion was documented with patient's family who requested DNR. Patient passed away in the early AM on 1/26. Demise does not appear to be related to COVID-19 vaccination but occurred in recent timeframe. Symptoms: ElevatedLiverEnzymes & death, pneumonia, afib",Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,,12/22/2020,01/26/2021,35.0,OTH,"Other Medication acetaminophen, albuterol/ipratropium, amlodipine, ascorbic acid, atorvastatin, baclofen, buspirone, calcium carbonate with vitamin D, cholecalciferol, dexmedetomidine, diltiazem, docusate, esomeprazole, famotidine, fentanyl",,,,,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Atrial fibrillation', 'Bacterial test positive', 'Bilirubin conjugated', 'Blood albumin', 'Blood bilirubin', 'Blood creatinine increased', 'Blood culture negative', 'Blood urea nitrogen/creatinine ratio', 'Bronchoscopy abnormal', 'Chest X-ray abnormal', 'Chest tube insertion', 'Condition aggravated', 'Culture urine negative', 'Cystatin C increased', 'Death', 'Dyspnoea', 'General physical health deterioration', 'Hepatic enzyme increased', 'Hypoxia', 'Intensive care', 'Ischaemic hepatitis', 'Klebsiella infection', 'Lung infiltration', 'Pneumonia', 'Protein total', 'Respiratory failure', 'SARS-CoV-2 test negative', 'Serratia infection', 'Spinal cord injury', 'Stenotrophomonas infection', 'Tachycardia', 'Tracheal aspirate culture']",3,PFIZER\BIONTECH, 1011990,,77.0,M,"Thrombocytopenia, SkinRash, Rash & ElevatedBunSCr Narrative: Petichial rash. Patient had IV contrast dye 1/19 no reaction. Patient on Apixiban for a. fib.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/22/2021,01/24/2021,2.0,OTH,,,,,,"['Atrial fibrillation', 'Blood creatinine increased', 'Blood urea increased', 'Petechiae', 'Rash', 'Thrombocytopenia']",1,PFIZER\BIONTECH,IM 1011996,,65.0,M,"Dizziness, Diarrhea, Bradycardia, hypokalemia Narrative:",Not Reported,,Yes,Yes,,Not Reported,U,01/19/2021,01/20/2021,1.0,OTH,,,,,,"['Bradycardia', 'Diarrhoea', 'Dizziness', 'Hypokalaemia']",2,PFIZER\BIONTECH,IM 1012076,IL,29.0,F,received Pfizer covid vaccine on 1/19/2021 - started showing symptoms of appendicitis (abdominal bloating and slight pain) on 1/21/2021 and worsened until I needed to have a laparoscopic appendectomy on 1/25/2021,Not Reported,,Not Reported,Yes,,Not Reported,,12/28/2020,01/25/2021,28.0,UNK,"Minocycline 135mg (for acne), fish oil, probiotic, vitamin D, multivitamin","utilizes marijuana socially (2x/week), social alcohol use (2x/month)",No medical conditions,,No known allergies,"['Abdominal distension', 'Abdominal pain', 'Appendicectomy', 'Appendicitis', 'Computerised tomogram abdomen', 'Laparoscopic surgery']",UNK,PFIZER\BIONTECH, 1012078,MA,,M,"Report involves two products - COVID-19 Moderna vaccine (Moderna) and Invega Trinza (Janssen). Patient is my brother and I am company employee. Patient began Invega sustenna Dec-2016 and transitioned to Invega Trinza 2 years later. Patient has been on same dose of Invega trinza for at least a year. Regimen has been followed per prescribing instructions (per psychiatrist). Patient received first dose of Moderna COVID-10 vaccine at his place of employment on 24-Dec-2020. Last/most current dose of Invega Trinza was 15- Jan-2021. Patient then received 2nd dose of Moderna vaccine AM of 21-JAN-2021 (same location). Patient began severe pain in eyes, chills, myalgia (beginning 01:00 22-Jan-2021) and had to call in sick to work on 22-Jan-2021. Patient went for COVID-19 test on 22-Jan-2021 and result was negative. By 23/24-Jan-2021 patient began displaying symptoms of psychosis to family. Work colleagues noted that week of 25-Jan-2021 he was ""not himself"". Suicidal ideation (in emails) began 01-Feb-2021, symptoms intensified and currently 04-Feb-2021, patient is missing, endangered and in state of psychosis. Since patient is missing, I will serve as reporter in this case At the time of this report company was notified at 20:53 UTC and Moderna will be notified next after completion of this report.",Not Reported,,Yes,Not Reported,,Not Reported,,,01/22/2021,,UNK,please refer to description -; unknown,none,schizoaffective bipolar - dx 2015,,nkda,"['Abnormal behaviour', 'Chills', 'Drug interaction', 'Eye pain', 'Impaired work ability', 'Myalgia', 'Psychotic disorder', 'SARS-CoV-2 test negative', 'Suicidal ideation']",1,MODERNA,IM 1012079,NJ,57.0,F,"My platelets dropped from 382k to under 10k 2 days after receiving Moderna Covid-19 Vaccine. I experienced bloody nose, Petechia, oral blood blisters, bruising, bleeding gums and was bedridden with fatigue.",Not Reported,,Yes,Not Reported,,Not Reported,,01/21/2021,01/23/2021,2.0,UNK,Promacta Viibryd Xanax Vitamin C Calcium Multi vitamins,,ITP,,,"['Bedridden', 'Contusion', 'Epistaxis', 'Fatigue', 'Full blood count', 'Gingival bleeding', 'Oral blood blister', 'Petechiae', 'Platelet count decreased']",UNK,MODERNA, 1012080,CA,67.0,M,Dexcom Continuous Glucose Sensor failed. Contacted Dexcom explained the problem (failed sensor). They declined to help and blamed Tandum and transferred to them. They said NO NO this is a Dexcom problem and transferred me back! Dexcom identified the problem and offed to send a replacement vis 3-7 days vis ground shipping! A week without a CGM sensor!!! I expressed concern and asked for overnight. One week ago I got the Moderna vaccine and suffered Diabetic Ketoacidosis. Failed sensor has resulted in elevated BG. Last week I had Ketoacidosis following moderna Covid-19 vaccine. Being without continuous BG testing is dangerous. Raised my concerns with Dexcom. Asked for call back and action.,Not Reported,,Not Reported,Not Reported,,Yes,,,02/04/2021,,UNK,"too long to list all Insulin, too long to list",,Diabetes TypeI,,,"['Blood glucose increased', 'Condition aggravated', 'Diabetic ketoacidosis', 'Ketoacidosis']",UNK,MODERNA, 1012200,TX,,M,"PATIENT'S WIFE REPORTED THAT PATIENT PASSED AWAY ON 01/16/21. BOOSTRIX WAS LAST IMMUNIZATION TAKEN ON 11/26/20 PNEUMAVAX, ONLY RECEIVED REFERRAL PNEUMAVAX RX WAS NEVER RECEIVED",Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,,11/28/2020,01/16/2021,49.0,UNK,"GLIPIZIDE, HYDROCHLOROT, JANUVIA, LISINOPRIL, LOVASTATIN, METFORMIN, NOVLOLOG MIX 70/30, SYMLNPEN",,"DMII OPHTH UNCNTRLD, DMII WO CMP NT ST UNCNTR",,,['Death'],UNK,GLAXOSMITHKLINE BIOLOGICALS,IM 1012226,FL,50.0,F,"Member has reported was hospitalited for Pulmonary Embolism that happened, COVID-19. States COVID-19 vaccination 02FEB2021, physician ordered to not take therapy until the 2nd COVID-19 vaccination on 23FEB2021. Also, experiencing hands & feet are swollen. Event Ongoing.",Not Reported,,Not Reported,Yes,,Not Reported,,,,,UNK,Humira; Levofloxacin; Nitrofurantn,,"IRON DEFICIENCY ANEMIA, ATRIAL PREMATURE DEPOLARIZATION, CHRONIC MAXILLARY SINUSITIS, RHEUMATOID ARTHRITIS, SYTEMIC INVOLVEMENT OF CONNECTIVE TISSUE",,UNKNOWN,"['COVID-19', 'Peripheral swelling', 'Pulmonary embolism']",UNK,UNKNOWN MANUFACTURER, 1012387,PA,,M,Severe chest pain with radiation to left chest and jaw 5 days after moderna covid vaccine. No heart attack but diagnosed with pericarditis. Will be in treatment for 3 months.,Not Reported,,Not Reported,Yes,,Not Reported,,02/01/2021,02/05/2021,4.0,UNK,Prilosec,,Reflux,,None,"['C-reactive protein increased', 'Chest pain', 'Electrocardiogram abnormal', 'Inflammatory marker increased', 'Pain', 'Pain in jaw', 'Pericarditis', 'Red blood cell sedimentation rate increased']",UNK,MODERNA, 1013348,NY,51.0,F,"C/O Anxiety, feeling faint, trouble breathing, chest pressure she C/O feeling faint and was brought to cot to lay down, then C/O trouble breathing, Vital signs were monitored and EMS was called. She was transported by EMS to hospital",Not Reported,,Not Reported,Yes,,Not Reported,U,02/04/2021,02/04/2021,0.0,OTH,none,none known,none,,none known,"['Anxiety', 'Chest discomfort', 'Dizziness', 'Dyspnoea']",2,MODERNA,IM 1007470,GA,78.0,M,"Patient presented with night sweats and shortness of breath the day after receiving the second dose of the COVID vaccine. Initially presented to his PCP and received levaquin for presumed PNA, but subsequently presented to the ED with persistent SOB and fatigue. Admitted to the ICU on AIRVO for high O2 requirements. Chest CT showing dense ground-glass opacities with interlobular septal thickening and mild crazy paving pattern. Currently admitted and undergoing workup.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/05/2021,01/26/2021,21.0,UNK,"acyclovir (acyclovir 400 mg oral tablet) 400 mg, PO, BID azelastine-fluticasone nasal (Dymista 137 mcg-50 mcg/inh nasal spray) 1 spray(s), Nasal, BID caffeine (caffeine 100 mg oral tablet) 100 mg, PO, BID clobetasol topical (clobetasol 0.05",,"IgG MM in sCR s/p auto-SCT 7/2015, hypogammaglobulinemia, organizing pneumonia (thought 2/2 pomalidomide), pAF on AC, DVT (2016), hypothyroidism, HTN",,"Metoprolol, statins","['Aspergillus test', 'Blood culture negative', 'Computerised tomogram thorax abnormal', 'Cryptococcus test', 'Dyspnoea', 'Fatigue', 'Intensive care', 'Laboratory test normal', 'Legionella test', 'Lung disorder', 'Lung opacity', 'Night sweats', 'Pleural thickening', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH, 1007587,AL,54.0,F,"Arm turned red at injection site and hot. There was really no pain and went away within a couple of day but turned red again exactly a week later from injection date. This time it was hard, hot, red, itchy, and bigger. Dr treated it with clindamycin and dose pack of steroids. It got better after a few days. Next, I got a UTI and called my primary care physician. She ordered CIPRO and phenazopyridine. That got better but before CIPRO was finished, I got a crick in my neck that turned into excruciating pain in my neck and was unable to turn head from side to side. At the same time, my left foot became painful, red and swelled. I have been treated for arthritis in that foot 6 years ago with an injection. I have not had any problems with it since the injection. Dr. treated my neck problem with Robaxin and a steroid dose pack. This seemed to help my foot too temporarily. Neck pain improved but not gone. It was excruciating pain up the back of my scalp at times. I can turn my head some now but it's not back normal. Can't turn it all the way. Dr. did another injection in my foot but did not work this time. I got worse and I can no longer put any weight on that foot. I have not been able to work since January 20. Have had to apply for leave of absence and short-term disability",Not Reported,,Not Reported,Not Reported,,Yes,N,12/23/2020,01/18/2021,26.0,PVT,"Levothyroxine, multivitamin, vitamin D, meloxicam, atorvastatin, ambien",None,"Hypothyroidism, arthritis",,"Penicillin, sulfa","['Erythema', 'Impaired work ability', 'Injection', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Joint range of motion decreased', 'Laboratory test', 'Magnetic resonance imaging', 'Mobility decreased', 'Musculoskeletal stiffness', 'Neck pain', 'Pain in extremity', 'Pain of skin', 'Peripheral swelling', 'Spinal X-ray', 'Urinary tract infection', 'Weight bearing difficulty', 'X-ray limb']",1,MODERNA,SYR 1007596,PA,41.0,F,"After receiving 2nd dose of vaccine on 1-25-2021 at 11:20, I had spiked a fever of 104.00, nausea, body chills, lethargy, vomiting, head ache and arm pain. Took 50 hours to get out of bed and feel half normal. Thought I was on the road to recovery when the arm pain started to increase. No rash or swelling occurred at the sight. It presents with pain more nerve like pain in my shoulder, elbow and radiated to fingers. On Feb 5th the pain was so bad I went to see a shoulder specialist and are trying to figure out what is going on. My right arm remains painful to move with nerve issues. The specialist advise I report. In the meantime, I will follow up Monday with another specialist and also undergo some nerve testing.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/25/2021,01/25/2021,0.0,PVT,None,None,None,,None,"['Arthralgia', 'Chills', 'Headache', 'Lethargy', 'Nausea', 'Neuralgia', 'Pain', 'Pain in extremity', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,SYR 1007616,MD,88.0,M,"Pt. tested positive for SARS-CoV-2 on 2/3/2021 and required hospitalization for associated diarrhea and dehydration with mild acute kidney injury. Of note, he has not been hypoxic and has not required supplemental oxygen to maintain his SaO2 as of 2/6/2021.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,01/11/2021,02/03/2021,23.0,PVT,1) ALOGLIPTIN 6.25MG TAB TAKE ONE TABLET BY MOUTH EVERY ACTIVE DAY FOR DIABETES 2) AMMONIUM LACTATE 12% CREAM APPLY LIBERALLY TO ACTIVE AFFECTED AREA EVERY DAY FOR DRY SKIN. USE ON YOUR FEET WHERE YOU HAV,None,"Chronic illnesses include diabetes type 2, essential hypertension, colonic arteriovenous malformations, benign prostatic hypertrophy and prostate cancer s/p radiation therapy c/b chronic urinary obstruction/retention (does not have chronic indwelling urinary catheter)",,"vardenafil (nausea/vomiting), sildenafil (nausea/vomiting), lisinopril (cough)","['Acute kidney injury', 'Alanine aminotransferase normal', 'Aspartate aminotransferase normal', 'Blood creatinine increased', 'Blood lactate dehydrogenase normal', 'C-reactive protein increased', 'COVID-19', 'Chest X-ray abnormal', 'Clostridium test negative', 'Dehydration', 'Diarrhoea', 'Fibrin D dimer', 'Haemoglobin decreased', 'Lymphocyte count normal', 'Mean cell volume normal', 'Procalcitonin increased', 'Red blood cell sedimentation rate increased', 'SARS-CoV-2 test positive', 'Serum ferritin normal', 'White blood cell count decreased']",1,PFIZER\BIONTECH,IM 1007628,FL,69.0,F,I received my second shot on Friday 01/29/21 at 5:30 pm. The next morning (01/30/21) at @ 10:45 am I experienced an extremely rapid heart rate (195+) which did not go down even after laying down and putting my feet up. My husband took me to the hospital ER and they gave me cardizem (10 mg via I?ve) which brought it down. I was let there for four hours then transferred to the main hospital and kept overnight in the cardiac decision unit and monitored. I really released @ 12:25 pm on 01/30/21 and referred to my own cardiologist,Not Reported,,Yes,Yes,1.0,Not Reported,U,01/29/2021,01/30/2021,1.0,SEN,Simvastatin 20 mg 1x a day at bedtime Amlodipine 5m 1x a day at bedtime Omeprazole cap 20 mg 1x a day before breakfast,None,High blood pressure under control with medication- blood pressure in normal range,,None,"['Blood test normal', 'Electrocardiogram normal', 'Heart rate increased']",2,PFIZER\BIONTECH,SYR 1007629,VA,44.0,M,"Patient reported right sided facial drooping on 2/1/2021 stating that it began three days prior to him reporting it. MD documentation: Pt unable to blink right eye, lift right brow and right side of mouth is drooping. PERLA. Pt denied right sided weakness/headache. Pt has demonstrated elevated blood pressures since receiving Covid 19 Vaccine not previously demonstrated.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/26/2021,01/30/2021,4.0,OTH,Albuterol Inh 90 mcg,,Asthma,,PCN,"['Blood pressure increased', 'Corneal reflex decreased', 'Eyelid function disorder', 'Facial paralysis']",1,MODERNA,IM 1007832,VA,24.0,F,I developed swelling and hives over 75% of my body and was given a shot of Epi shot because my throat closed. I developed a weakened immune system from the vaccine. I am 8 week pregnant and developed a Blighted Ovum and I am currently going through a miscarriage to date. Rather not release any info regarding the pregnancy,Not Reported,,Not Reported,Yes,5.0,Not Reported,N,12/21/2020,01/10/2021,20.0,MIL,no,no,no,,no,"['Abortion spontaneous', 'Anembryonic gestation', 'Exposure during pregnancy', 'Immune system disorder', 'Swelling', 'Throat tightness', 'Urticaria']",1,PFIZER\BIONTECH,IM 1007900,IL,68.0,M,Bells palsy,Not Reported,,Not Reported,Yes,2.0,Yes,N,01/01/2021,02/05/2021,35.0,PVT,Proscar Symbicort Flonase Singulair Flomax,None,BPH Seasonal allergies,,None,"['Computerised tomogram head', 'Facial paralysis', 'Magnetic resonance imaging']",1,MODERNA,IM 1007928,IN,72.0,M,Patient recieved 2 doses of covid vaccine by pfizer. Frist dose was on 1/15/21 (EL8982) and the next day patient was admitted for fever and altered mental status. Spent one week in hospital. Pt recieved the 2nd vaccine for covid on 2/5/21 (EL9265) and then spiked fever and readmitted the very next day for fever and altered mental status. Noted to have a bullous rash over the injection site.,Not Reported,,Not Reported,Yes,7.0,Not Reported,U,02/05/2021,02/05/2021,0.0,PVT,"Amlodipine, Vitamin C, Baclofen, Carbamazepine, Carvedilol, Dabigatrain, Doxazosin, Lasix, Irbesartan, Lamotrigine, Pantoprazole, rosuvastatin, Vitamin D, Vitamin E, Multivitamin",,,,"Lyrica, Lactose, Penicillin","['Dermatitis bullous', 'Injection site rash', 'Mental status changes', 'Pyrexia', 'Vaccine positive rechallenge']",2,PFIZER\BIONTECH,IM 1007933,MO,39.0,F,"Adverse event happened immediately after injection. Heat wave, rapid heart rate, increase respirations, feeling of water dripping inside my arm, High Blood Pressure. Since then I have had feelings of ""vibrations"" running up and down my spine, arms, head, neck, chest, legs. I have been to the Chiropractor, Urgent Care Clinic, PCP, ER. Waiting to see a Neurologist... All of these symptoms happened after the 1st dose of the covid vaccine, and have worsened each day since. January 18 2021 to Current date. I have a detailed list of times, dates, and actions.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/18/2021,01/18/2021,0.0,PVT,"Women's 1 a day multi-vitamin, Elderberry 50 mg",No known illnesses,None,,Slight latex allergy...causes a rash,"['Computerised tomogram', 'Feeling hot', 'Heart rate increased', 'Hypertension', 'Immediate post-injection reaction', 'Laboratory test', 'Respiratory rate increased', 'Sensory disturbance', 'Vibratory sense increased', 'X-ray']",1,PFIZER\BIONTECH,IM 1007937,TX,43.0,F,"Seconds after the injection I had severe dizziness and was sore on the vaccine sight. Within 12 hrs of that I experienced stomach flu-like symptoms, next it was body aches and difficulties breathing. My chest began hurting by my heart. My symptoms worsened by the hour",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/03/2021,02/03/2021,0.0,OTH,Aimovig Zomig Baclofen Benadryl Tylenol Ibuprofen,No,Heart disease- diastolic heart failure Rheumatoid Arthritis Fibromyalgia Chronic migraine,,Demorol Robitussin,"['Abdominal discomfort', 'Blood test', 'Chest X-ray', 'Chest pain', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Influenza like illness', 'Injection site pain', 'Pain']",1,MODERNA,SYR 1008041,MN,100.0,M,"itchy skin, swelling, disorientation that led to a fall",Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,SEN,"Acetaminophen, bisacodyl supplement, levsin (hyscyamine)",gout,"congestive heart failure diagnosis, alzheimers",,,"['Disorientation', 'Fall', 'Pruritus', 'Swelling']",1,MODERNA,SYR 1008159,VA,54.0,M,"Abdominal pain woke me from sleep at 3 am. 1/29/21. Went to ER that night, studies negative. Sent home. Went back to ER next day. Studies negative. Sent home. Went back to ER same night. Admitted. Had laparoscopic appendectomy on 2/2/21",Not Reported,,Yes,Yes,4.0,Not Reported,N,01/16/2021,01/29/2021,13.0,PVT,"HCTZ 25 mg daily, magnesium oxide 500 mg daily",None,"Hypertension, asthma",,Penicillin,"['Abdominal pain', 'Appendicectomy', 'Computerised tomogram abdomen normal', 'Laboratory test', 'Laparoscopic surgery', 'Sleep disorder', 'Ultrasound scan normal']",2,PFIZER\BIONTECH,IM 1008241,CT,60.0,F,"On 1/27/2021 was to have stress echo done with imaging -- when injected with Lumason -- I had an immediate, severe anaphylaxis shock requiring transport to hospital, intubation, and short MICU stay -- was referred to allergist who felt the PEG in Covid vaccine sensitized me to the PEG in Lumason thus resulting in severe allergy",Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/02/2021,01/27/2021,25.0,PUB,"Calcium supplement, multivitamin",None,None,,Polyethylene glycol -- identified on 02/01/2021,"['Anaphylactic shock', 'Blood test', 'Chest X-ray', 'Computerised tomogram head', 'Contrast media allergy', 'Endotracheal intubation', 'Intensive care', 'Stress echocardiogram']",1,MODERNA,IM 1008285,CA,41.0,M,First dx of diverticulitis with microperforation,Not Reported,,Not Reported,Yes,,Not Reported,N,01/01/2021,01/13/2021,12.0,UNK,,,,,,['Diverticulitis intestinal perforated'],2,PFIZER\BIONTECH,IM 1008345,MN,29.0,F,"32 Weeks pregnant Due Date: 4/1/2021 1st child About 8 hours after I started with nausea and a little fatigue. I woke up the next morning with joint and muscle pain. That lasted a full day along with the nausea. I did take Tylenol, it didn't take it away but made it more tolerable. This lasted for about two days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,WRK,Prenatal Zoloft Zyrtec,,,,,"['Arthralgia', 'Exposure during pregnancy', 'Fatigue', 'Myalgia', 'Nausea']",1,PFIZER\BIONTECH,SYR 1008359,MN,44.0,M,"I developed acute right posterior pleuritic chest pain and shortness of breath. Diagnosed with multiple pulmonary emboli (see below). I was started on Eliquis initially, but then had worsening symptoms on 2/4/21 and switched to Lovenox injections. Symptoms have been slowly improving since then.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/12/2021,02/01/2021,20.0,PVT,Flonase nasal spray,none,Protein C deficiency,,sulfa antibiotics cashews and pistachio food intolerance,"['Angiogram pulmonary abnormal', 'Chest pain', 'Computerised tomogram thorax abnormal', 'Dyspnoea', 'Fibrin D dimer increased', 'Pulmonary embolism', 'Scan with contrast']",2,PFIZER\BIONTECH,IM 1008377,PR,80.0,F,"DISORIENTED AND SLOW IN MOVEMENTS DIFFICULTY IN GETTING DRSS DIFICULT IN COORDINATION CHANGE IN PERSONALITY ,AND NOT HERSELF. ALL THIS AFTER THE VACCINE . SHE IS NOT HERSELF",Not Reported,,Not Reported,Not Reported,,Yes,N,02/02/2021,02/02/2021,0.0,OTH,Altase 10 metropolol 50 sintroid 1 calcium 600mg 2 tablets caltrate,no,no,,no,"['Abnormal behaviour', 'Blood test', 'Bradykinesia', 'Chest X-ray', 'Computerised tomogram', 'Coordination abnormal', 'Disorientation', 'Electrocardiogram', 'Loss of personal independence in daily activities', 'Personality change']",1,MODERNA,IM 1008450,MO,41.0,M,"Developed DVT in left leg from groin to ankle. Diagnosed on 01/29/2021. Pain, swelling, and difficulty walking lead to emergency room visit, admission to hospital for 2 days.",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/12/2021,01/12/2021,0.0,PVT,None,None,None,,None,"['Computerised tomogram pelvis', 'Computerised tomogram spine', 'Deep vein thrombosis', 'Full blood count', 'Gait disturbance', 'International normalised ratio', 'Metabolic function test', 'Pain', 'Prothrombin time', 'Swelling', 'Ultrasound scan']",2,PFIZER\BIONTECH,IM 1008473,TX,37.0,M,"Tuesday afternoon began with a headache. Chills followed in the late evening. Body aches by Wednesday morning with continued headache. Neck stiffness and soreness began Thursday evening. Severe chest pains early Saturday morning (3am). Taken to urgent care - EKG showed irregularity and high level of troponin. Transported from there to the hospital. They did angiogram, and diagnosed me with pericarditis. The on call physician believes this was most likely caused by the second dose of the vaccine.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/02/2021,02/02/2021,0.0,PVT,NONE,NONE,NONE,,NONE,"['Angiogram abnormal', 'Chest pain', 'Chills', 'Electrocardiogram abnormal', 'Headache', 'Musculoskeletal stiffness', 'Neck pain', 'Pain', 'Pericarditis', 'Troponin increased']",2,MODERNA,IM 1008476,KY,42.0,M,"On January 18, two days after getting the first dose of the vaccine I woke up with a sense of fullness or pressure in my left ear, mild sinus congestion, and chills. The congestion and chills ended after one day, but the feeling of fullness in the ear has persisted to this day. Then, on January 29, I had a bout of positional vertigo and vomiting that lasted two to three hours. I also experienced ringing or roaring in my left ear. Ever since, I have a bout of vertigo approximately every 24 hours, and the ringing and sense of fullness in the ear ebb and flow on 24 hours cycles as well. This experience has been debilitating and affected my ability to work. My doctor has diagnosed Meniere's disease and says he has been seeing similar symptoms apparently linked to the COVID vaccines. I started taking prednisone on doctor's orders yesterday (February 5), which has stopped the vertigo. Ringing and occasional fullness in the ears persist.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/16/2021,01/18/2021,2.0,PVT,"None; I have a prescription for Albuterol for asthma, but I rarely take this medicine.",None,"Asthma, mild.",,None.,"['Asthenia', 'Audiogram normal', 'Chills', 'Ear discomfort', 'Impaired work ability', ""Meniere's disease"", 'Sinus congestion', 'Tinnitus', 'Vertigo positional', 'Vomiting']",1,PFIZER\BIONTECH,SYR 1008492,TX,26.0,F,Pt received first dose 1/5/2021. Pt received second dose 02/01/2021. Pt started to have SOB and tachycardia 2/2/20201. She presented to Hospital and was diagnosed and admitted with a pulmonary embolism. She is a paramedic in our EMS system. It is not known to me whether she had other risk factors for a pulmonary embolism.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/01/2021,02/02/2021,1.0,OTH,unknown,unknown,unknown,,unknown,"['Dyspnoea', 'Pulmonary embolism', 'Tachycardia']",2,MODERNA,IM 1008547,IA,78.0,F,AMS-Fever-UTI-myoclonic jerks-unresponsive <6hrs post 1st covid vaccine. AMS-UTI- post 2nd covid vaccine,Not Reported,,Yes,Yes,19.0,Not Reported,N,01/13/2021,01/13/2021,0.0,SEN,,Cdiff.,"2nd covid vaccine yesterday, recently admitted for sepsis � � HPI: 78 y.o. who presented from nursing home due to altered mental status. She was discharged on 2/2/2021 after having a prolonged hospitalization for sepsis secondary to Enterococcus UTI presenting with altered mental status. Her past medical history significant for recurrent UTI, type 2 diabetes mellitus, hyperlipidemia, hypertension, GERD and chronic diastolic heart failure. She is presents today from nursing home with altered mental status, hypoxia and low-grade fever. EMS reported that the patient blood pressure was in the 80s/40s, her temperature was 38 �C and slightly tachycardic. She was oriented to self only, they found her to be hypoxic and started on 2 L of oxygen. Upon arrival to the ED her blood pressure was 95/66, she was satting 94% on 2 L of oxygen, heart rate 106 and she was afebrile. Her chest x-ray showed mild pulmonary congestion but was negative for frank pulmonary edema. Her EKG showed sinus rhythm with ST depression and T wave inversions. CBC showed hemoglobin of 8.8 which is at her baseline, WBC count of 3.5, renal panel showed serum creatinine 1.3 compared to normal baseline. Her troponin was elevated at 0.37, NT proBNP 16,555. She is sleepy however is arousable, could not participate much to history. At time of my evaluation she is sleepy but arousable, on 2 liters oxygen by nasal cannula. She denied pain however has frequently asked to be left alone and would go back to sleep. History is obtained by chart review. ED has discussed the case with CVICU fellow who deemed the patient appropriate for medical floor.",,NKA,"['Blood creatinine increased', 'Chest X-ray abnormal', 'Electrocardiogram', 'Electrocardiogram ST segment depression', 'Electrocardiogram T wave inversion', 'Electrocardiogram abnormal', 'Full blood count', 'Haemoglobin decreased', 'Hypoxia', 'Intensive care', 'Mental status changes', 'Myoclonus', 'N-terminal prohormone brain natriuretic peptide increased', 'Pulmonary congestion', 'Pyrexia', 'Sepsis', 'Somnolence', 'Tachycardia', 'Troponin increased', 'Unresponsive to stimuli', 'Urinary tract infection', 'White blood cell count decreased']",2,PFIZER\BIONTECH,IM 1008601,NY,21.0,F,"21 y.o female woke up had breakfast and while at rest Developed palpitation , shortness of breath and some pain in lower middle teeth. The teeth pain lasted less than 30 minutes , other symptoms lasted from 7 am till about 1 pm and then gradually subsided except mild ""racing heart"" feeling. Patient went to urgent care. EKG showed some non specific ST depression in AVF and lead II. Sinus arrhythmia with rate between 65-85. . Sent to ED. In ED EKG was same as in urgent care. Troponin elevated slightly at 0.36 ( normal less than 0.30) and the repeat in 1 hour 0.37 ( normal less than 0.30) . D dimers noted slightly elevated at 260. POssible diagnosis of ""inflammatory syndrome"" by ED physician . Patient was offered admission , but refused and went home to follow up with cardiologist as outpatient. As per ER attending : ""it almost looks like COVID or post COVID syndrome"" Rapid COVID test negative. Symptoms started in the morning of the 3rd day after 2nd COVID vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/03/2021,02/06/2021,3.0,UNK,none,none,none,,Bactrim,"['Dyspnoea', 'Electrocardiogram ST segment depression', 'Fibrin D dimer increased', 'Palpitations', 'SARS-CoV-2 test negative', 'Sinus arrhythmia', 'Toothache', 'Troponin increased']",2,MODERNA,IM 1008614,MA,92.0,M,Four hours after the vaccine had no strength and could not walk at all. in addition all the pains he had before escalated so he needed very strong pain relievers. Also lack of comprehension when we got the ER.,Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/01/2021,02/01/2021,0.0,PVT,"Multiple medications, please contact hospital for the list",Had pain in his hip and shoulder and was on antibiotics,High blood pressure Diabetic Obesity,,No known allergies,"['Asthenia', 'Confusional state', 'Gait inability', 'Laboratory test', 'Pain']",UNK,MODERNA,SYR 1008637,CA,66.0,M,"on 2/1/21 at ~7AM pt was noted by the RN to have rt sided weakness & was sent to Hospital ED for evaluation. They felt he could have had a TIA, or extension of a prior CVA (nothing new on MRI, has small vessel ischemic disease), or a COVID vaccine reaction. Symptoms have mostly resolved, he is not always cooperative so subtle weakness is difficult to detect. He was hospitalizaed, started on ASA & increased BP meds, and returned to his home, where he has resided for several years.",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/29/2021,02/01/2021,3.0,SEN,"Pantoprazole, lamiduvine, dolutagevir, Prezcovix, isordil, MVI, sevelamar, nephrocaps. on HD tiw","ESRD on HD MWF, htn, dementia, HIV, hx hep c (treated), hx TIA, hx CVA, COVID + (prior to vaccination)",see above,,NKDA,"['Cerebral microhaemorrhage', 'Cerebral small vessel ischaemic disease', 'Chest X-ray', 'Chest X-ray abnormal', 'Computerised tomogram head abnormal', 'Echocardiogram abnormal', 'Hemiparesis', 'Hypertensive encephalopathy', 'Magnetic resonance imaging brain abnormal', 'Pericardial effusion', 'Pleural effusion', 'Sinusitis']",2,PFIZER\BIONTECH,IM 1008707,PA,64.0,F,"My right shoulder was extremely painful. Unable to move or use my arm for 24 hrs. Was in so much pain that I took Oxycodone at 12:00 am, another at 3:00 am. TYLENOL with codeine at 5:00 am and another at 7 :00 am. Was not expecting so much pain. If I did not have the RXs, I would have to go to the emergency room. I still have pain and it goes down by arm. I have been told that the injection was given to high.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/04/2021,02/04/2021,0.0,PVT,,None,None,,None,"['Injected limb mobility decreased', 'Injection site pain', 'Pain', 'Product administered at inappropriate site']",2,MODERNA, 1008758,CT,94.0,F,"Patient began feeling nauseated on 1/18/21 around 6pm, and had uncontrolled diarrhea, reported that she did not feel right. Staff reported to this writer, that her skin tone was gray in tone and she just didn't look good. She was transferred to the HOSPITAL ER VIA AMBULANCE.",Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/18/2021,2.0,SEN,Lasix 10mg Aqupril Coumadin,,"Thrombocytopenia, A-fib, CHF, Spinal stenosis, Renal stent",,Codine,"['Diarrhoea', 'Full blood count', 'Metabolic function test', 'Nausea', 'Pallor', 'Urine analysis']",1,PFIZER\BIONTECH,IM 1008767,VA,71.0,F,"Acute appendicitis began with abdominal pain, vomiting on 2/3/21, surgery on 2/5/21. Confirmee by CT scan and operative procedure.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/19/2021,02/03/2021,15.0,PVT,None,None,History of PACs and sialadenitis,,None,"['Abdominal pain', 'Appendicitis', 'Blood electrolytes normal', 'Computerised tomogram abnormal', 'Full blood count normal', 'Surgery', 'Urine analysis normal', 'Vomiting']",UNK,PFIZER\BIONTECH, 1008768,WI,70.0,F,"Severe headache, face flushing, swollen tongue, throat closing off",Not Reported,,Yes,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,PVT,"AmLodPine, atorvastin, furosemide, calcium, gabapentin,levothyroxine, met form in, advair, albuterol, cetirizine, cymbalta, requip, famotidine, flax seed, losartan, montelukast, trazodone, vitamin D, humalog, Lantus, multivitamin, melatonin",Diabetes,"Severe back problems, fibrou, GERD, restless legs, asthma",,"Reglan, IVP dyes, penicillin, bethanechol, levequin, lisinopril, amoxicillin, augmentin, clindamycin, doxycycline, fish of any kind, sea food","['Flushing', 'Headache', 'Swollen tongue', 'Throat tightness']",1,PFIZER\BIONTECH,SYR 1008819,MA,72.0,M,"Received 1st COVID vaccine on 01/28/2021. Started to have some fevers, body ache, cough, mild sob starting 02/01/21. Tested COVID positive on 02/03/2021. Was been measuring SpO2 at home and was in the high 80s at home by 02 so referred to ED on 2/4/2021. Admitted 02/05/2021. Started on dexmethasone and supplemental oxygen.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/28/2021,02/03/2021,6.0,OTH,PredniSONE 5 mg PO DAILY 2. Sodium Bicarbonate 650 mg PO BID 3. Atovaquone Suspension 1500 mg PO DAILY 4. CARVedilol 6.25 mg PO BID 5. amLODIPine 10 mg PO DAILY 6. Famotidine 20 mg PO BID 7. LamiVUDine 100 mg PO DAILY 8. Simvastatin,,Status post kidney transplantation 2017 type 2 diabetes mellitus long-standing hypertension hyperlipidemia Hypertension Diverticulitis,,NKDA,"['COVID-19', 'Cough', 'Dyspnoea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1011757,,58.0,F,"Dizziness, Headache, Myalgia, HYPERtension, Syncope, Bradycardia, had flulike symptoms and rash with 1st dose, 2nd dose: during 15min observation period, felt weak, tingling all over body and felt weak on her right side and dizziness. lightheadedness, dizziness, and generalized weakness. slow to respond to questions, co Narrative: Other Relevant History:",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/04/2021,02/04/2021,0.0,OTH,,,,,,"['Asthenia', 'Bradycardia', 'Dizziness', 'Headache', 'Hemiparesis', 'Hypertension', 'Hyporesponsive to stimuli', 'Influenza like illness', 'Myalgia', 'Paraesthesia', 'Rash', 'Slow response to stimuli', 'Syncope']",2,MODERNA,IM 1015838,LA,80.0,M,"Patient was admitted to hospital from home in cardiac arrest. Hx of hypertension, hyperlipidemia, type 2 diabetes (not on insulin) and bilateral carotid artery stenosis. The patient was reportedly at his baseline health on 2/2/21. He received the 2nd dose of COVID vaccine around 1000AM on 2/2/21. Reportedly started running fever of 100.1 and chills the afternoon of 2/2/21. Around 7:00PM he started having dry cough and was complaining of breathing difficulties. He subsequently vomited multiple times (was eating pizza and aspirated) then lost consciousness. His wife called 911, did CPR and EMS reported he in PEA at scene and was intubated. Transported to hospital. SARS CoV-2 and influenza negative.",Yes,02/05/2021,Not Reported,Yes,3.0,Not Reported,,02/02/2021,02/02/2021,0.0,PVT,,,,,,"['Aspiration', 'Cardiac arrest', 'Chills', 'Cough', 'Dyspnoea', 'Endotracheal intubation', 'Influenza virus test negative', 'Loss of consciousness', 'Pulseless electrical activity', 'Pyrexia', 'Resuscitation', 'SARS-CoV-2 test negative', 'Vomiting']",2,UNKNOWN MANUFACTURER, 1016015,,56.0,F,"56 y.o. female with a history of a latex allergy, cancer and childhood asthma who received her second dose of the Pfizer COVID-19 mRNA vaccine and subsequently developed generalized pruritis five minutes after. She developed similar symptoms 6 hours after receiving the first dose, but this time was more severe. She arrived to the emergency department and after 15 minutes began to develop a cough, increased work of breathing, and voice changes. She received 0.3 mg epinephrine subcutaneously and albuterol nebulizers. Over her three hours in the department she received famotidine, 125mg methylprednisolone, diphenhydramine, an additional dose of epinephrine and 4x albuterol nebs. However, he dyspnea continued to return, and she was admitted. Improved overnight and was discharged HD2. widespread pruritis initially 5min post-Pfizer vaccination (2nd dose). Progressed to severe coughing, dyspnea requiring repeated doses of epinephrine and albuterol. Admitted to intermediate unit for further cares. Noted to have had mild delayed pruritis prior to first dose of pfizer vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,,,,,UNK,,,Asthma/COPD; Cancer; Anaphylaxis from latex,,,"['Cough', 'Dysphonia', 'Dyspnoea', 'Pruritus']",2,PFIZER\BIONTECH,IM 1008948,CO,47.0,F,"2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing with chest tightening, heart racing, numbness and tingling on my mouth and chin, tongue swollen and turned grey in a matter of a few minutes. I took Benadryl, an epinephrine pen, and a nebulizer and began to start feeling better in 15 minutes. Following the 2 weeks I felt nauseous, chills, cold sweat, lightheaded, weak, tired, headache and pain in arm/shoulder.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,Before Vaccine nothing.,,,,,"['Anaphylactic reaction', 'Arthralgia', 'Asthenia', 'Chest discomfort', 'Chills', 'Cold sweat', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Nausea', 'Pain in extremity', 'Palpitations', 'Paraesthesia oral', 'Swollen tongue', 'Tongue discolouration']",2,PFIZER\BIONTECH,SYR 1008972,NY,48.0,F,When my first dose was administered on this day I felt a pain go down my arm. I continue to have pain in my elbow/forearm area. I cannot lift or reach for objects as i was able to prior to the shot. My day to day duties continue to be affected.,Not Reported,,Not Reported,Not Reported,,Yes,N,12/29/2020,12/29/2020,0.0,SCH,famotidine,,,,NKA,"['Arthralgia', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Pain in extremity']",1,MODERNA,IM 1009029,IL,71.0,M,First reaction total loss of hearing in right ear. Returned after 6 hours. Next day partial loss of hearing in left ear. Did not return to normal hearing.,Not Reported,,Not Reported,Not Reported,,Yes,N,01/19/2021,01/22/2021,3.0,PVT,Anti rejection medications for kidney transplant,Kidney transplant,Kidney transplant Heart by pass,,Pennicillink,"['Deafness unilateral', 'Hypoacusis']",UNK,MODERNA, 1009153,VA,38.0,F,"First injection on 12/19/2020 followed by arthralgias. Second dose on 1/7/2021, starting around 11 AM on 1/9/2021, significant myalgias and arthralgias which evolved into involuntary choreoathetoid movements requiring hospitalization. I presented to the ED around 15:30 on 1/9/2021 with subsequent admission and work up as listed below.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/07/2021,01/09/2021,2.0,PVT,Vyvanse 50 mg QAM and 20 mg Q afternoon Bupropion SR 150 mg QAM,None,None,,None,"['Arthralgia', 'Blood test normal', 'Choreoathetosis', 'Computerised tomogram head normal', 'Echocardiogram normal', 'Electrocardiogram normal', 'Electroencephalogram normal', 'Lipids', 'Lumbar puncture normal', 'Magnetic resonance imaging brain normal', 'Myalgia', 'Positron emission tomogram abnormal', 'Streptococcus test', 'Viral titre increased']",2,PFIZER\BIONTECH,IM 1009224,VA,48.0,F,"Pt was treated with bactrim days before COVID vaccination. Then days after COVID vaccination, had Bactrim again. Anaphylactic rxn occurred 1-2 days later. Reaction was likely related to Bactrim, but did receive COVID vaccination in same time period.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/01/2021,02/03/2021,33.0,PVT,"Macrobid, bactrim",UTI,,,now Bactrim is drug allergy,"['Anaphylactic reaction', 'Drug hypersensitivity']",1,MODERNA,IM 1009266,NY,85.0,F,"Patient with failure to thrive symptoms prior to 2nd dose, not eating, not taking medications.",Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,U,01/24/2021,02/07/2021,14.0,SEN,"atorvastatin 40 mg tablet furosemide 20 mg tablet lamotrigine 200 mg tablet lisinopril 2.5 mg tablet meclizine 12.5 mg tablet metoprolol tartrate 50 mg tablet miconazole nitrate 2 % topical cream nystatin 100,000 unit/gram topical powder Re",Kidney Stones,"CVA, AFib, SSS, Epilepsy, Vascular Dementia",,"Garlic; IV contrast, Iodine containing; mirabegron","['Adult failure to thrive', 'Decreased appetite', 'Eating disorder', 'Failure to thrive', 'Refusal of treatment by patient']",2,PFIZER\BIONTECH, 1009282,MT,26.0,M,Rhabdomyolysis,Not Reported,,Not Reported,Yes,6.0,Not Reported,,01/25/2021,01/27/2021,2.0,PVT,"Lamotrigine ER 100mg & 200 mg, multi-vitamin",,Seizure disorder,,,['Rhabdomyolysis'],1,PFIZER\BIONTECH,IM 1009401,NC,52.0,F,patient started feeling as though her throat was closing and short of breath,Not Reported,,Yes,Yes,2.0,Not Reported,Y,02/05/2021,02/05/2021,0.0,PVT,"metoprolol, trazodone, zonisamide",none,"HTN, Migraines",,"bees, latex, morphine","['Dyspnoea', 'Throat tightness']",UNK,PFIZER\BIONTECH, 1009423,,39.0,F,Swelling of lips and tongue,Not Reported,,Yes,Yes,,Not Reported,,02/05/2020,02/06/2020,1.0,UNK,,,,,,"['Lip swelling', 'Swollen tongue']",UNK,MODERNA, 1009424,WA,52.0,M,"2 weeks after my second shot, I had a CVA causing complete loss of sensation in my left arm. I am in good health and do not have multiple risk factors for CVA. While the scans showed evidence of a CVA, no underlying cause has yet to be determined.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/11/2021,01/27/2021,16.0,PVT,Multivitamin every few days.,,None.,,,"['Blood test', 'Cerebrovascular accident', 'Computerised tomogram', 'Magnetic resonance imaging', 'Scan with contrast', 'Sensory loss', 'Ultrasound scan']",2,PFIZER\BIONTECH,IM 1009429,PA,71.0,M,The patient started with sudden onset double vision nd ambulatory dysfunction. The patient was taken via ambulance to R/O CVA. MRI results unremarkable. The patient was diagnosed with INTERNUCLEAROPHTHALMPOPLEGIA. Possible cranial nerve 6 palsy.,Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/25/2021,02/01/2021,7.0,PUB,Simvastatin 20 MG QD Sotalol 120 MG BID Losartan 50 MG QD,None,Elevated cholesterol Heart arrhythmia,,NKDA,"['Blood test normal', 'Diplopia', 'Magnetic resonance imaging normal', 'Musculoskeletal disorder', 'Ophthalmoplegia']",1,MODERNA,IM 1009530,SC,91.0,M,"Headache, fever, uncontrollable shaking, heart rate 104, bp 140/86 called 911, ambulance ride to above Hospital. IV on route, Kept over night in hospital. Shake stopped in about 2 hours , continued rapid heart for awhile and fever, Hospital gave him tylenol. after about 4 hours his bp fell to 89 over 64 ... thus keeping him in hospital. They did multi tests. found an unknown infection in his blood. Patient has had an elevated WBC but in hospital it was 50,000. two weeks ago at his primary Dr. it was 40,000. He walks with a walker and cane, however he has lost his balance and fallen 3 time since vaccine and one of those was today.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/04/2021,02/05/2021,1.0,PVT,"finasteride, 5 mg, Lisnopril 10 mg, 2000 Vitamine C daily, 500 B, 10000, D-3, Centrium Silver 1 tab. Miacinamide, 500 mg all daily.","elevated white blood count, misc. skin cancers. Deaf in right ear.",all above,,none,"['Balance disorder', 'Blood pressure decreased', 'Fall', 'Headache', 'Heart rate increased', 'Infection', 'Laboratory test abnormal', 'Pyrexia', 'Tremor', 'Walking aid user', 'White blood cell count increased']",UNK,MODERNA, 1009761,MO,69.0,F,"Started within 2 hours of vaccine (8 pm) an extremely sore arm. Then the pain started to radiate to my shoulder. By the next day, it was really painful in my shoulder and across my back almost to my backbone. It was painful to move my arm up or down or to reach for things. This lasted 3 to 4 days. Then my neck on the same side as the shot (left) began to hurt so badly I couldn't move my neck up or down or sideways. It was strange the way the pain slowly moved across by arm to my shoulder to my back and up my neck. I've never experienced anything like this before. Today my pain in my neck is bearable but I have soreness and a headache. I hope I am at the end of the cycle to this event as I am scheduled for my next shot soon.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/26/2021,01/26/2021,0.0,OTH,"Levothyroxin, Acyclovir, Gabapentin, Ezetimibe, Hydroxychloroquine, Fluoxetine, Vitamin C, Vitamin E, Vitamin D3, Zinc, Aspirin, Magnesium, Probiotics, Herb-Lax.",,"Lupus, Lyme disease, Hypo-thyroid, Mennieres Disease",,Sulfa,"['Arthralgia', 'Back pain', 'Headache', 'Mobility decreased', 'Neck pain', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH,IM 1009786,PA,69.0,M,"Altered Mental Status, Spasmodic Muscle Movements, Fever",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,02/01/2021,02/02/2021,1.0,SEN,"Aldactone, Atorvastatin. Bethanechol, Carbidopa-levodopa, Cogentin, Coumadin, Depakote, Humalog R, Imdur, Lasix, Levimir, Melatonin, Mirapex, Oxubutynin, Plavix, Propanol, Protonix, Seroquel, Synthroid, Trazadone, Zonisa",Covid-19,"Parkinson's Disease, Diabetes Mellitus Type 1, Hypothroidism, Anxiety Disorder, Schizoaffective Disorder, Hypokalemia, Convulsions, Atherosclerotic Heart Disease, Bipolar Disorder, Congestive Heart Failure, Hyperlipidemia, Prostatic Hyperplasia, Peripheral Vascular Disease, Below Knee Amputation",,"Hydrocodone, Sulfa Antibiotics, ACE Inhibitors, Celexa, NSAIDs","['Chest X-ray abnormal', 'Computerised tomogram head normal', 'Dyskinesia', 'Lung opacity', 'Mental status changes', 'Pyrexia', 'Urine analysis normal']",2,PFIZER\BIONTECH,IM 1009797,IN,39.0,F,"Systemic Inflammatory Response Syndrome, Fever, Pancytopenia, Myalgia, Tachycardia",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/04/2021,02/04/2021,0.0,PVT,Multi vitamin PRN klonopin,None,Depression/anxiety,,Unknown,"['Blood test', 'Computerised tomogram', 'Myalgia', 'Pancytopenia', 'Pyrexia', 'Scan with contrast', 'Systemic inflammatory response syndrome', 'Tachycardia', 'X-ray']",2,MODERNA,IM 1009813,,95.0,M,Patient became immobile on 1/25/21 (4 days after receiving Moderna COVID-19 vaccine). He died on 1/27/21,Yes,01/27/2021,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/25/2021,24.0,UNK,,,,,,"['Death', 'Immobile']",UNK,MODERNA, 1009817,GA,,F,"Three days following the receipt of the Covid vaccine, I lost all hearing in my left ear. I was diagnosed with ""sudden sensory nerve severe hearing loss"" by an ENT",Not Reported,,Not Reported,Not Reported,,Yes,N,01/11/2021,01/14/2021,3.0,PVT,"Anastrozole 1 mg tab, aspirin 81 mg, Ducosate Sodium 100 mg #4, Effexor XR 10mg, Famotidine 40 mg, Hydrochlorothiazide 25 mg, Losartan potassium 50 mg #2, Naratriptan HCL 2.5 mg as needed, Prolia injections q6months, Raberprazole sod 20 mg",None,migraine headaches gerd,,None,"['Deafness neurosensory', 'Deafness unilateral', 'Magnetic resonance imaging brain', 'Sudden hearing loss']",1,MODERNA,IM 1009821,MO,83.0,M,Ischemic stroke 2 days following vaccine administration resulting in hospitalization. Symptoms began with left lower extremity weakness. The patient also reported a low-grade fever as well as fatigue and generalized weakness following vaccine.,Not Reported,,Not Reported,Yes,,Not Reported,,02/04/2021,02/06/2021,2.0,UNK,"Allopurinol, aspirin, lisinopril, pravastatin",COVID-19 infection in early January,"arthritis, coronary artery disease, hyperlipidemia, gout, shingles, hypertension",,penicilliin,"['Asthenia', 'Fatigue', 'Ischaemic stroke', 'Muscular weakness', 'Pyrexia']",UNK,MODERNA,IM 1009827,MI,28.0,M,"Chest pain- pericarditis. Elevated troponin. Heart cath. PCU hospital admit. No previous heart hx. Ekg abnormal. Echo, mri.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/04/2021,02/06/2021,2.0,PUB,"Concerta , abilify, clonidine",Nasal congestion/ cough three to four weeks prior,Adhd; mood swings; sleep apnea,,None,"['Catheterisation cardiac', 'Chest pain', 'Echocardiogram', 'Electrocardiogram abnormal', 'Laboratory test', 'Magnetic resonance imaging', 'Pericarditis', 'Troponin increased', 'X-ray']",2,MODERNA,IM 1009831,MO,33.0,M,"10 hours after receiving injection, spontaneously began feeling cold, shivering to rigors, rapid heart rate increased respiratory rate, lips and nail bed dusky, T37C. Took to ER, Temp 101 F and experienced a grandmal seizure, lasting approximately 1 minute of vigrous movement. froathing and flaying . Temp up to 103F. tachycardia and SOB, PO2 in 90's blood pressure low 78/45 88/50 after 3 liters of fluid up to 100/50. Chest Xray, EKG, multiple labs blood and one urine text.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,OTH,"Divalproex sod.ER, Escitalopram, Ganapentin, Lamotrigine, Zonisamide, Tylenol, Ibuprofen, Calciul, Vit E , Vit c and Vit e",none,dadnywalker cyst with complex VA shunt system and a medically resistant seizure disorder,,Latex,"['Blood test', 'Body temperature increased', 'Chest X-ray', 'Chills', 'Condition aggravated', 'Dyskinesia', 'Dyspnoea', 'Electrocardiogram', 'Feeling cold', 'Foaming at mouth', 'Generalised tonic-clonic seizure', 'Heart rate increased', 'Hypotension', 'Laboratory test', 'Lip discolouration', 'Nail discolouration', 'Respiratory rate increased', 'Tachycardia', 'Urine analysis']",1,PFIZER\BIONTECH,IM 1009860,FL,73.0,F,"Acute intractable generalized abnormal movements. Writhing, choreiform movements x3 days until presented to hospital. Given Ativan 2 mg IV and Keppra 1g IV with resolution",Not Reported,,Not Reported,Yes,,Not Reported,U,02/03/2021,02/04/2021,1.0,PVT,Sinemet 25/100 TID Synthroid 100 mcg Celebrex 200 mg BID Imipramine 50 mg TID Omeprazole 20 mg qd Mirapex 4 mg qd Ativan 1 mg PRN Trazadone 10 mg qhs,None,Parkinsonisms Hypothyroidism GERD,,NKA,"['Chorea', 'Computerised tomogram head normal', 'Dyskinesia', 'Full blood count', 'Full blood count normal', 'Metabolic function test', 'Metabolic function test normal']",2,PFIZER\BIONTECH,UN 1009865,CA,84.0,F,Vaccine received at 1:30 pm. At approx 7 pm my mother sat in chair at table and was unable to get up or walk for over an hour. She was leaning sideways in her chair. Paramedics had to carry her to gurney as she could not stand or walk on her own. Taken to ER and observed overnight. Was able to walk with walker within a few hrs and back to normal strength next day.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/06/2021,02/06/2021,0.0,PUB,"Advair, Combivent, Losartan, Hydrochlorothiazide, Meloxicam, Tamoxifen, low dose aspirin, Vitamin C, Centrum Silver",Later in evening after vaccine was advised may have UTI,"Asthma/COPD, osteoarthritis, marginal zone lymphoma (currently monitoring only, no treatment)",,"Sulfa drugs, macrobid","['Blood test', 'Computerised tomogram', 'Dysstasia', 'Gait inability', 'Posture abnormal']",1,PFIZER\BIONTECH,SYR 1009866,FL,85.0,F,"pt was given vaccine on the afternoon of 01-29-2021. Pt was administered the moderna covid-19 shot into the deltoid muscle of this pt. Pt was observed and left pharmacy. on 2-6, pts daughter calls pharmacy, and says the night of 1-29, after recieveing the vaccine, her mother had a hemmorhagic stroke and passed away",Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,PHM,unknown,unknown new pt,unknown,,penicillins,"['Death', 'Haemorrhagic stroke']",1,MODERNA,IM 1009884,TX,78.0,M,"Fell, head injury and vertebrae fractured. Probable stroke. Dizziness.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/25/2021,01/29/2021,4.0,OTH,"brilinta, norvasc, coreg, tresiba,",,"DM type II, HTN, dialysis, stroke, heart disease, full whipple",,NKA,"['Cerebrovascular accident', 'Dizziness', 'Fall', 'Head injury', 'Spinal fracture']",1,PFIZER\BIONTECH,IM 1009952,MI,88.0,M,Extreme confusion High blood pressure was suddenly very high He wandered out of his apartment in the middle of the night. Ambulance picked him up. He was fine before the vaccine.,Not Reported,,Not Reported,Yes,21.0,Yes,N,01/11/2021,01/12/2021,1.0,PVT,Eliquis Metprolol Zoloft,Some confusion and memory problems which increased extremely after the vaccination. He started wandering out the house and couldn?t remember anyone. He went to hospital by ambulance where he was treated for high blood pressure and wasn?t able to stand up straight.,High blood pressure Diabetes High cholesterol,,,"['Condition aggravated', 'Confusional state', 'Dysstasia', 'Hypertension', 'Patient elopement']",1,PFIZER\BIONTECH,IM 1009954,PA,59.0,F,Shoulder pain when rotating arm around,Not Reported,,Not Reported,Not Reported,,Yes,N,12/18/2020,12/18/2020,0.0,PVT,Omepraxole Escitalopram Provastanin,None,None,,None,"['Arthralgia', 'Pain']",1,PFIZER\BIONTECH,IM 1009966,PA,42.0,M,"Nausea, body pain, diarrhea, fever, chills",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/02/2021,02/02/2021,0.0,MIL,,,"Stage 5 kidney disease, hart disease",,,"['Chills', 'Diarrhoea', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,SYR 1009991,NY,73.0,M,"73-year-old man s/p first dose of Pfizer at 10:20 AM Ambulated comfortably to exit after 20 minutes in observation but 10:45 collapsed while exiting the building 10:47 CPR initiated 10:49 medical team/EMS found no pulse, agonal respirations, ventricular fibrillation Paramedics and team performed ACLS; of note patient was intubated 7.5 ETT with bilateral breath sounds on ventilation; paramedic reported easy intubation with no apparent throat swelling; 11:02 transported to Emergency Department 11:30 Pronounced dead at Emergency Department",Yes,02/07/2021,Yes,Not Reported,,Not Reported,N,02/07/2021,02/07/2021,0.0,OTH,Unknown,Unknown,"Believed to have chronic atrial fibrillation, believed not to be on anticoagulants",,No severe allergies reported on questionaire,"['Circulatory collapse', 'Death', 'Endotracheal intubation', 'Mechanical ventilation', 'Pharyngeal swelling', 'Pulse absent', 'Respiration abnormal', 'Resuscitation', 'Syncope', 'Ventricular fibrillation']",1,PFIZER\BIONTECH,IM 1009995,OH,59.0,F,Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest. Treatment: dexAMETHasone sodium phos (PF) given at 4:49 pm. diphenhydrAMINE (Benadryl) given at 4:46 pm. famotidine (PEPCID) given at 4:47 pm.,Not Reported,,Yes,Not Reported,,Not Reported,Y,02/06/2021,02/06/2021,0.0,PVT,"Lisinopril, 20 mg tablet, 1 per day. Multivitamin. Cranberry fruit extract. Estroven complete. Probiotic. CoQ10. Joint health (UC-II Collagen). Krill oil. Allegra Allergy.",None.,High blood pressure.,"Zoster Vaccine Live. Rash, swelling and soreness. Date: 7/15/2020","Peanuts, Tree nuts, NSAIDs, penicillin.","['Anaphylactic reaction', 'Chills', 'Hypertension', 'Rash']",1,PFIZER\BIONTECH,IM 1010025,GU,92.0,F,Patient Expired,Yes,01/10/2021,Yes,Not Reported,,Not Reported,N,12/30/2020,01/09/2021,10.0,PVT,"Nifediac, Losartan, Atorvastatin, Allopurinol, Glipizide, Pantoprazole, Amoxicillin","NIDDM, CHF, HTN, HLD","NIDDM, CHF, HTN, HLD",,None known,['Death'],UNK,PFIZER\BIONTECH,IM 1010030,WA,45.0,F,"Adverse reaction started with very dark urine ,fatigue. fever fluctuating and severe sweating ,shivers ,dizzy and back pain. I was very worried about the dark urine because I had history of hemolytic anemia. I went to ER and got diagnosed with Hemolytic Anemia after blood and urine test. Admitted to hospital overnight and dismissed with my request to do so with steroid prescription of steroid prednisone 20MG 3 tablets a day for 7days to suppress my immune response for for the vaccine that believed to be one which triggered the Hemolytic Anemia. following up with Hematologist on Monday with extra blood draw to monitor my situation. Still not feeling well with fatigue, back lower pain and dizzeness .i still look yellow and urine dark .",Not Reported,,Yes,Yes,1.0,Not Reported,N,02/03/2021,02/05/2021,2.0,UNK,tylanol,None,previous history of Hemolytic Anemia,,Aspirine/ Augminton antibiotic,"['Anxiety', 'Back pain', 'Blood lactate dehydrogenase increased', 'Chills', 'Chromaturia', 'Condition aggravated', 'Dizziness', 'Fatigue', 'Haemolytic anaemia', 'Hepatic enzyme increased', 'Hyperhidrosis', 'Malaise', 'Pyrexia', 'Urine analysis', 'Yellow skin']",2,MODERNA,SYR 1010062,NC,32.0,F,"Extreme swelling in arm pit lymph nodes, with small bumps around the injection site and back of my arm. The injection site was a light purple. The spots They grew red and increased in amount. They formed a solid plaque in the back of my armpit, deltoid, and back. It was extremely itchy with pins and needles pain.",Not Reported,,Not Reported,Not Reported,,Yes,U,12/29/2020,01/05/2021,7.0,WRK,,,"Asthma, basic nasal allergies",,Sensitive to doxycycline,"['Injection site discolouration', 'Injection site rash', 'Lymphadenopathy', 'Paraesthesia', 'Rash', 'Rash macular', 'Rash pruritic', 'Scar']",1,MODERNA, 1010105,,38.0,M,"Eleven days after the vaccination the patient developed 2 days of heartburn followed by a worsening nonproductive cough, substernal chest pain, diaphoresis, palpitations, and an episode of near syncope. These worsened over about 6 days and then slowly decreased. During this time he was referred to the ED and then admitted to a civilian host nation hospital. Echocardiogram and CT scan were performed and a paericardial cyst was discovered measuring 7.4 cm. He was then referred to another facility for evasluation. The pericardial cyst was confirmed, now 6.5 cm and laboratory tests were performed on 4 FEB, but there was at that time no elevation in inflammatory markers. Cardiology and Cardiothoracic Surgery consultations were obtained, but the consultants and the attending physician (who is an infectious disease physician by training) did not think that the crescendo-decrescendo symptoms could be explained by the pericardial cyst, which was likely an incidental finding. A milder cough may have preceded these events by up to a year, and this may possibly be related to the cyst. The heartburn, chest pain, tachycardia, diaphoresis, palpitations, and near syncope may well be adverse reactions of the vaccine.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/14/2021,01/25/2021,11.0,MIL,None. He uses sumatriptan as needed.,None.,"Migraines,",,"codeine, morphine, sulfa drugs.","['Chest pain', 'Computerised tomogram', 'Cough', 'Dyspepsia', 'Echocardiogram', 'Eosinophil count normal', 'Hyperhidrosis', 'Inflammatory marker test', 'Palpitations', 'Pericardial cyst', 'Presyncope', 'Tachycardia', 'White blood cell count normal']",1,MODERNA,IM 1010113,WI,28.0,F,"Miscarriage - first vaccine at 10 weeks and 3 days with prior proof of heartbeat/movement, second vaccine at 13 weeks and 3 days; learned of miscarriage at 14 weeks 3 days with measurements of 12 weeks 3 days on U/S",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/21/2021,14.0,PVT,"Prenatal vitamin, Diclegis",None,None,,None,['Abortion spontaneous'],2,PFIZER\BIONTECH,IM 1010114,GU,58.0,M,Patient passed away (Dead on Arrival on presentation to ER) on 02/03/2021,Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/03/2021,6.0,PVT,unknown,"anemia, NIDDM, ESRD on Hemodialysis, AFib, CAD S/P CABG, COPD , HTN, recently diagnosed with COVID in September, 2020.",,,unknown,"['Death', 'SARS-CoV-2 test']",1,MODERNA,IM 1010149,CA,83.0,F,Severe headache leading to disorientation and unresponsive condition requiring hospitalization.,Not Reported,,Not Reported,Yes,,Yes,N,02/05/2021,02/06/2021,1.0,PVT,Blood pressure medication. Trazadone for sleep.,None,High blood pressure.,,None,"['Disorientation', 'Headache', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,SYR 1010161,MS,77.0,F,Transiet Ischemic Attack,Not Reported,,Yes,Not Reported,,Not Reported,Y,01/18/2021,02/06/2021,19.0,PVT,amlodipine 10mg,,"hypertension, well controlled",,,['Transient ischaemic attack'],1,PFIZER\BIONTECH,IM 1020132,,80.0,M,"Weakness, hypernatremia",Not Reported,,Not Reported,Yes,,Not Reported,U,01/26/2021,01/29/2021,3.0,OTH,,,,,,"['Asthenia', 'Blood sodium increased', 'Hypernatraemia']",1,PFIZER\BIONTECH,IM 1020134,,61.0,M,"anxious, restless, weak, dizzy, felt ""horrible"". Continued to C/O symptoms,. At 01:15, patient lost consciousness , then stopped breathing and lost pulse. Narrative: Patient was first vaccinated for COVID 19 on 1/8/21. On 1/24/21: 61 year old presents to E.R. with CC of chest pain/sob, with multiple medical conditions including hypertension, atrial fibrillation on apixaban, cardiomyopathy with poor EF, dyslipidemia, COPD, CVA, lung CA s/p radiotherapy, PTSD, depression, Churg Strauss Syndrome, Sjogren's syndrome presented with chief complaint of chest pain or shortness of breath. He has been having worsening shortness of breath the past few days, also complains of cough productive of yellowish sputum, no hemoptysis. He complains of left upper chest pain with no radiation. There is no diaphoresis, palpitations or lightheadedness. He denies fever or chills. He complains of having fallen a few times recently, thus he passed out. Could not say if there were seizures activity. Admitted to 3D Tele. On 1/27, Pt advises he had episode of substernal CP this am. RN advises pt was in afib w/ RVR at a rate >140 at time of CP. Pt CP improved w/ prn NTG. Pt HR improved after daily medications. Pt sts his CP has resolved. Pt admits to continued dyspnea. Increased trop, transferred. 1/28, struggling with orthopnea and cough. He has no peripheral edema. He does have intermittent chest pain. Patient having periods of A-Fib RVR with non-sustained rates of 140's-150's 1/29 more chest pain at 04:00, relieved with NTG. HR = AF, with RVR 145. At about 08:00, Cardiology sees patient and signs off, ""shortness of breath and cough not due to heart failure as evidenced by orthostatic hypotension and no improvement in symptoms with diuresis. Consider underlying lung disease vs acute pulmonary disease."" No pulmonary consult noted. 1/29 Patient received 2nd dose COVID19 vaccine at about 3:30-4p. No notes from staff on this event. No notes from MD that this was discussed and still part of the plan. 1/29 nurse's note: At around 2240 Pt was able to rest briefly but is now restless and anxious again. Tachypneic, stating he feels so weak and dizzy and overall just feel horrible. Continuing to get up frequently to have small soft bowel movements with assistance. Pt also stated ever since he got ""that shot"" he hasn't felt well. When asked what shot pt replied ""COVID shot."" Pt did receive 2nd dose of COVID vaccine 1/29 at 1530. Around 2250 Spoke w MOD to relay above information and overall concern for pt, asked for MOD to come to bedside to evaluate pt. MOD states he's handing off to oncoming MOD and they will come to bedside to see pt. Around 2300 oncoming MOD called and all above and previous information discussed Around 2310 MOD came to bedside to see pt. Will continue to monitor closely. 01/30/2021 ADDENDUM Around 0115 pt called for help to use bedside commode to urinate and have BM. Assisted x2 to BSC. While sitting on BSC pt's eyes rolled back and pt made postures consistent with a seizure, body became very rigid. Pt was unresponsive still with pulse. Lifted patient back to bed with 3 staff assist. Pt stopped breathing and lost pulse. Chest compressions started immediately and Code Blue called at 0120. 1/30 Hospitalist note: Called for CODE BLUE AGAIN AT 4:53. While on Vent after s/p Code blue for reasons not clear patient went into Asystole and code called second time. Patient had a prolonged CPR and was actually called off at 5:17 but he started having pulse and agonal resp. he was placed on Levophed and D5NS. He got a total of 9 amps of epi, 3 amps od Bicarb and 1amp of D50. Trope bumped from 0.12 to 0.43 prior to this he already was on ASA, Apixiban for afib. Cards are on board for his CHF for his pulmonary edema Lasix ordered. Hid lactic acid is elevated. Blood cultures pending. Started Zosyn and is on Levophed. Continue to monitor. Updated patients Mom and she requested to do everything at this point. Coded again at 5:40, survived, but AOD writes a death note(?) Coded for the 4th time at 08:18. Family at beside, Mother asks for code to be stopped.",Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/29/2021,1.0,OTH,,,,,,"['Anxiety', 'Asthenia', 'Atrial fibrillation', 'Blood calcium decreased', 'Blood chloride normal', 'Blood creatinine increased', 'Blood culture', 'Blood lactic acid increased', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea increased', 'Carbon dioxide normal', 'Cardiac arrest', 'Cardiac failure congestive', 'Cardio-respiratory arrest', 'Chest pain', 'Death', 'Dizziness', 'Dyspnoea', 'Fall', 'Frequent bowel movements', 'Gaze palsy', 'Haematocrit decreased', 'Haemoglobin decreased', 'Loss of consciousness', 'Lung disorder', 'Malaise', 'Mechanical ventilation', 'Muscle rigidity', 'Orthopnoea', 'Orthostatic hypotension', 'Platelet count normal', 'Polyuria', 'Posturing', 'Productive cough', 'Pulmonary oedema', 'Pulse absent', 'Respiratory arrest', 'Restlessness', 'Resuscitation', 'Seizure', 'Sputum discoloured', 'Tachypnoea', 'Troponin I increased', 'Unresponsive to stimuli', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1020135,,93.0,M,"death Narrative: 92 yo male seen in clinic on 12/30/2020 for transfusion, hbg 6.9. PMH includes HLD, CKD, myelodysplastic syndrome, DM, prostate cancer, HTN. Pt also received COVID19 Pfizer vaccine the same day. The patient denied any prior severereaction to this vaccine or its components. Post-transfusion, patient had a mechanical fall (per patient he was seated and used the cane to help him stand. However the cane slipped on the floor causing the patient to fall, patient hit his head and injured his right hip, no loss of consciousness at the time). Rapid response team was called and patient was admitted to the ED. Pt was found to have subcapital right femoral neck fracture, scalp contusion, and TBI (per ED provider's note). Ortho evaluated and said patient wasn't a surgical candidate. During his hospitalization, patient tested positive for COVID19 on 1/12/2021, pt was asymptomatic at the time. On 1/13/2021, pt exhibited mild URI symptoms, no respiratory distress. He was started on cetirizine, Montelukast, albuterol, and inhaled steroids to manage his symptoms. Dexamethasone was started on 1/14/2021. Chest Xray was ordered on 1/17/2021, pt's respiratory was slowly getting worse, resting O2 sats were in the high 80s and low 90s with IS. On 1/18/2021, CXR shows patchy bilateral airspace opacities suspious for pneumonia of bacterial or viral etiology. Pt was started on remdesivir 01/18/2021 (5 doses, from 1/18-1/22/2021). Pt required 5-6 LPM of oxygen at rest. Pt was then transferred to the ICU. His oxygen demand continued to increase and his condition worsened. On 2/14/2021, pt started to desat into the 70s on max high flow. Patient/family agree to comfort care. Medical cause of death was listed as ""acute hypoxic respiratory failure due to COVID19."" Patient expired 1/24/2021.",Yes,01/24/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/24/2021,25.0,OTH,,,,,,"['COVID-19', 'Chest X-ray abnormal', 'Contusion', 'Craniocerebral injury', 'Death', 'Fall', 'Femoral neck fracture', 'Haemoglobin decreased', 'Head injury', 'Intensive care', 'Joint injury', 'Lower urinary tract symptoms', 'Lung opacity', 'Pneumonia', 'Respiratory failure', 'SARS-CoV-2 test', 'Skin laceration', 'Transfusion', 'Upper respiratory tract infection', 'Walking aid user']",UNK,PFIZER\BIONTECH,IM 1010183,NY,38.0,F,"rash, abdominal pain, nausea, vomiting, diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/03/2021,02/07/2021,4.0,OTH,"Xanax, Ventolin",None,"Asthma, Hyperlipidemia",Influenza,Flu vaccine and Naproxen,"['Abdominal pain', 'Diarrhoea', 'Nausea', 'Rash', 'Vomiting']",1,PFIZER\BIONTECH,IM 1010184,CA,41.0,F,delayed swelling at site of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,02/05/2021,8.0,UNK,"Albuterol, Flonase",None,"Asthma, eczema",,NKDA,['Injection site swelling'],UNK,MODERNA, 1010185,CA,57.0,F,"Pt reports chest tightness, tongue numbness, normal EKG. Pt recovered",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/07/2021,02/07/2021,0.0,OTH,None,None,None,,Oranges,"['Chest discomfort', 'Electrocardiogram normal', 'Hypoaesthesia oral']",1,PFIZER\BIONTECH,IM 1010186,CA,30.0,F,"Itchiness, hard lump/swelling, and large red circle all at injection site. No symptoms prior. Began on day 8 past injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/06/2021,8.0,OTH,"Nifedipine, prenatal vitamin",None,"Hypertension, obesity",,None,"['Injection site erythema', 'Injection site induration', 'Injection site mass', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 1010187,IN,39.0,F,"All over body aches (especially left arm near injection site) headache and dizziness through out the day on 2/6/21. Around 11:10 pm on 2/6/21, I noticed my left bicep was swollen, after checking not only was it swollen, it was very hard to the touch as well as a red circle around the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/06/2021,1.0,PVT,Sharobel 0.25 mg (birth control),none away of,depression/anxiety hearing loss (wear bilateral hearing aids for past 12 years),"Tetatnus (two localized reactions (first bullseye around injection site. Second time, bullseye as well as entire arm swollen for",Tetanus vaccination - two localized reactions (doctor recommend to no longer get it due to increased severity of reaction),"['Dizziness', 'Headache', 'Injection site erythema', 'Injection site pain', 'Pain', 'Peripheral swelling']",2,MODERNA,IM 1010188,VA,40.0,M,I experienced Shingles less than two weeks after the initial vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/20/2021,9.0,PVT,None,None,None,,None,['Herpes zoster'],2,PFIZER\BIONTECH,IM 1010189,CA,46.0,F,"2/1/2021 2 PM headache 6 PM lightheaded dizzy nauseous headache light sensitivity itchy 8 PM nauseous itchy can?t lift my arm on my side dizzy headache exhaustion 11:45 PM nauseous dizzy full body aches arm incredibly painful shortness of breath crawling out of my skin I?m so itchy 2/2/2021 12:15 AM finished hysterically crying cannot use my left arm still crawling out of my skin On and off sleep until 11 AM headache exhaustion cannot lift my arm 1:30pm my hand is frozen a claw position Can?t get out of bed headache sore throat 6pm move to couch with bad headache, nausea and fatigue 2/3/2021 6am leave couch work - with bad headache, nausea and fatigue 2/4/2021 In bed all day fatigue, headache, nausea 2/5/2021 a bit better",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,OTH,"omeprazole, loratadine, probiotic VSL #3, Centrum multivitamin, Triple Flex joint suppliment",,"nerve damage right ankle, missing gall bladder -digestive issues, depression",flu shot - always down about 2 days with fatigue arm sourness,"Yeast, penicillin, codine, vicodine, scented products, parabens","['Dizziness', 'Dyspnoea', 'Fatigue', 'Headache', 'Injected limb mobility decreased', 'Injection site pain', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Photophobia', 'Pruritus']",1,MODERNA,SYR 1010190,CA,26.0,F,Had muscle fatigue and chills with low grade fever for 6-7 hours. The injection site started swelling Saturday afternoon and increased in size and redness very fast. I applied an ice pack and took an Advil. Sunday the injection site is still swollen.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,OTH,None,None,None,Swelling at injection site from flu shot late fall.,None,"['Chills', 'Injection site erythema', 'Injection site swelling', 'Muscle fatigue', 'Pyrexia']",UNK,MODERNA, 1010191,CA,80.0,U,"Dizzy, headache and weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/07/2021,02/07/2021,0.0,OTH,"Insulin, Aspirin, Lisinopril, T4,",,"DM2, HTN, lipedema, hyperthyroid, CAD",,"NSAIDS, Trimodal, prednisone","['Asthenia', 'Dizziness', 'Headache']",1,PFIZER\BIONTECH,IM 1010192,CA,66.0,F,Felt weak,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/07/2021,02/07/2021,0.0,OTH,Unknown,None,"DM, HTN, Anxiety",,"Seafood, Bactrim",['Asthenia'],1,PFIZER\BIONTECH,IM 1010194,CA,65.0,F,"HA over R-eye, dizzy, shaky, no breakfast, no BS check., BS @ 14:18: 294",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/07/2021,02/07/2021,0.0,OTH,Insulin,,"DM, TN, Cirrhosis,",,Codeine,"['Blood glucose increased', 'Dizziness', 'Tremor']",1,PFIZER\BIONTECH,IM 1010195,CA,45.0,F,"Pfizer-BioNTech COVID19 Vaccine Severe symptoms following day: injection site pain, fatigue, headache, whole body muscle pain, chills, nausea, malaise. 2nd and 3rd day symptoms: left underarm swollen lymph nodes, injection site pain, headache, tiredness, slight nausea, slight muscle pain. Missed work 1 day, unable to drive 2 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/05/2021,1.0,PUB,"Cymbalta, Ibuprofen, Women's Multivitamin, Melatonin",None,"Asthma, Obesity",,Vicodin,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Malaise', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,IM 1010196,CA,38.0,F,Severe Anxiety and agitation (brain fog to some extent),Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,WRK,"Levothyroxine, Spironolactone, Multivitamin, Supplement for mood (includes: St. John's Worth, Ashwagandha, etc.), Homeopathy remedy, multivitamin","Thyroid Hashimoto's, Thalassemia Minor, OCD, Anxiety and Depression","Same as above, neck and back pain",,,"['Agitation', 'Anxiety', 'Feeling abnormal']",1,PFIZER\BIONTECH,SYR 1010197,PA,34.0,F,"Lip swelling, nausea, vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,WRK,Sumatriptin. Took Zyrtec prior to vaccine.,Covid in November.,None,"31yo, tdap when pregnant, anaphylaxis.",Tdap. Cephalosporin.,"['Lip swelling', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 1010198,CA,72.0,M,"""eyes looking foggy"" L-eye red",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/07/2021,02/07/2021,0.0,OTH,Unknown,none,"A-fib, HTN, Blood thinners, PE x 2 5 years ago.",,none,"['Abnormal sensation in eye', 'Ocular hyperaemia']",1,PFIZER\BIONTECH,IM 1010199,AZ,67.0,F,"Almost three weeks after the shot I had a half dollar size red spot on the arm. It is now going on 5 days and it is not as red, like it is disappearing.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,02/04/2021,13.0,PVT,"Glipizide, Metformin, Lisinopril, Atorvastatin, Levemir",none,Diabetes,,none known,['Injection site erythema'],1,MODERNA,SYR 1010200,CA,76.0,M,Pressure in chest & cough,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/07/2021,02/07/2021,0.0,OTH,Losartan,None,"Asthma, DM, HTN",,None,"['Chest discomfort', 'Cough']",1,PFIZER\BIONTECH,IM 1010201,AZ,57.0,F,covid arm - a raised ring like rash around the site of the shot,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/06/2021,10.0,PVT,"Paroxitine 20mg; Simvastatin, Glimipiride 6mg, Janumet, Multivitamin, Calcium",None,"Diabetese, Depression",,None,['Injection site erythema'],UNK,MODERNA, 1010202,NY,43.0,F,"6pm left arm sore. 9pm started with chills, headache, body aches, and fever 100.3.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/03/2021,0.0,WRK,None,No,No,,NKDA,"['Chills', 'Headache', 'Limb discomfort', 'Pain', 'Pyrexia']",2,MODERNA,SYR 1010203,AR,39.0,F,"Bullseye-like rash, hard to the touch, swollen, itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,02/07/2021,11.0,PVT,,,,,"Penicillin, mushrooms, cat dander, seasonal","['Induration', 'Pruritus', 'Rash erythematous', 'Swelling']",1,MODERNA,SYR 1010204,FL,71.0,F,"Headache,nausea,vomiting, diarrhea pain in extremities aching",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/06/2021,2.0,OTH,"Levothyroxine 88 mg , hydrocodon 10-325, Eliquis 5mg x2",None,Back pain,,NSAID,"['Arthralgia', 'Diarrhoea', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Vomiting']",1,MODERNA,SYR 1010205,TN,25.0,M,"Developed fever, chills, headache, nausea, fatigue, and severe pain at the injection sight. The fever developed about 8 hours after taking the vaccine. I had previously had COVID back in August and this is what it felt like for me.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,PUB,Zyrtec,None,"Endometriosis, migraines",,None,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pyrexia']",UNK,MODERNA, 1010206,CA,45.0,F,nausea headache Dizziness pain swelling at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,MIL,Tylenol,No,No,,No,"['Dizziness', 'Headache', 'Injection site pain', 'Injection site swelling', 'Nausea']",1,MODERNA,SYR 1010207,CA,67.0,M,"HA x 10 mins, feels dizzy",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/07/2021,02/07/2021,0.0,OTH,"Metformin, Aton statin , lisinopril, insulin",None,"DM2, hyperlipidemia, HTN",,"PCN, Sulfa",['Dizziness'],1,PFIZER\BIONTECH,IM 1010208,,86.0,F,"Soreness in upper right arm, beginning around 7 pm day of shot, injection site; soreness lessened next day, none after couple of days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/23/2021,0.0,UNK,,,,,,"['Injection site pain', 'Limb discomfort']",UNK,MODERNA, 1010209,CA,41.0,F,"Racing heart, nervousness, severe fatigue, chills, body aches, fever of 101.6, headache, loss of appetite,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,WRK,None,None,Slightly elevated inflammation,,None,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Nervousness', 'Pain', 'Palpitations', 'Pyrexia']",UNK,MODERNA,SYR 1010210,NY,41.0,F,I felt very dizzy and started walking back to my room. Before I could get to my room I fell to the ground. I never lost consciousness but I couldn?t get up for about two minutes. I intentionally slept for the rest of the day and did not have any further severe adverse effects but that one really shook me!,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/06/2021,2.0,PVT,Claritin-D Multivitamin,N/a,N/a,,N/a,"['Dizziness', 'Fall']",2,MODERNA,IM 1010211,IL,55.0,F,COVID arm. Hard bump for a week then really itchy and about a 8 inch red circle around shot sight for an additional week. Itching only lasted a couple of days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/11/2021,7.0,PUB,Synthroid,None,None,,None,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus']",1,MODERNA,IM 1010212,WA,34.0,F,15 hours after receiving second dose I experienced severe aches in my body which was in my joints and bones. Hot and cold chills. 101 degree temp 2 days after the second dose I developed a large bullseye rash about 2 inches under the injection site. That same arm feels asleep,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/07/2021,2.0,WRK,Ibuprofen Vyvanse Birth Control,None,ADD,,Bactrim,"['Chills', 'Injection site erythema', 'Injection site rash', 'Pain', 'Pyrexia']",2,MODERNA,SYR 1010213,AZ,38.0,F,"Feverish, chills, headaches, nausea, dry mouth, and sleepiness the day after the Vaccine was taken. Started out slowly late morning around 9am and got worse by the afternoon. Took Motrin to relieve symptoms and slept. The next day felt better but in the evening on 2/5/21 felt itchy starting from arms and neck. Then after about 10 min of itchiness in that area and started itchiness down to my stomach and legs. I took allergy medication prescribed by my physician: Cetirizine HCL 10mg tablet (1 tablet). No issues after that. Had some issue with the itchiness from the first dose around the 3rd-5th day after the first vaccine was given. Didn't take any allergy medications and had a tiny bit of dark circular spots on limps and torso but wasn't severe. Thought that was from something I ate, or clothes detergent, etc. so shrugged it off.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/04/2021,1.0,UNK,Multivitamins,None,None,,Amoxicillin,"['Chills', 'Dry mouth', 'Headache', 'Nausea', 'Pruritus', 'Pyrexia', 'Somnolence']",2,PFIZER\BIONTECH,SYR 1010214,OR,37.0,F,Lymph node under arm pit swollen and painful for over 24 hours. Same arm as injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,PVT,,,,,,['Lymphadenitis'],2,MODERNA,SYR 1010215,OK,24.0,F,My eyes have been occasionally twitching (lasts about 3 seconds) and this doesn't really happen. It occurs randomly throughout the day. I got the 2nd dose on the 4th but it's still happening as I'm typing this report.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/06/2021,2.0,UNK,None,None,,,Raw egg whites (it's th eprotein),['Eye movement disorder'],2,MODERNA,IM 1010217,,30.0,M,"Chills starting around 10:30 PM, joined shortly after by an increasingly painful headache. Alternating between chills and being overheated on and off all night, while headache became worse. Had to take ibuprofen at 7:30 AM after not being able to sleep, and was able to sleep. Woke up at 1 PM and had to take another ibuprofen for the headache. Chills were gone, but was overheated and sweating for an hour or two. Had to take another ibuprofen at night, but headache wasn't too much worse. Headaches were gone upon waking up at 9 AM on Sunday. Experienced lymph node swelling in armpit of arm that got the vaccination. Tried to do pushups, but became too painful. I had also experienced the lymph node swelling after my first vaccination 28 days before my second one. About a week after, and they always felt minorly swollen up until the time of my second vaccination. I didn't know they were caused by the vaccine until after the second vaccination. Currently 1:20 AM on Monday, and I have been experiencing redness and itching in a large patch around the vaccination site all day.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/05/2021,02/05/2021,0.0,PVT,"Omeprazole, propecia",,,,Pine nuts,"['Chills', 'Headache', 'Hot flush', 'Hyperhidrosis', 'Lymphoedema']",2,MODERNA, 1010218,IN,25.0,M,"Body aches, head ache, chills for about 7 hours from 03:00 am until 11:00 am",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,UNK,None,None,None,,None,"['Chills', 'Headache', 'Pain']",2,PFIZER\BIONTECH,UN 1010219,CA,44.0,F,Itchy red welts that were painful to touch on my left arm in injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,02/07/2021,9.0,PUB,"Relpax 20 mg as needed, wellbutrin 300 mg daily, sumatriptan 50 mg as needed",None,Migraines,,None,"['Injection site erythema', 'Injection site rash']",1,MODERNA,SYR 1010220,CO,43.0,F,"About one week after my second shot, my hair began falling out in significant amounts. This has been continuing for several weeks now.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/27/2021,7.0,MIL,"Synthroid, ortho tri cyclen lo",,thyroidectomy,,nka,['Alopecia'],2,MODERNA,IM 1010222,AZ,55.0,F,"I felt numbness going up my neck while I waited in line after receiving the vaccine. I thought it was nerves. No one asked how I felt after the vaccine and was passed along ( I told my daughter - who drove me - about my neck while at the vaccine site.) I noticed that my face was also going numb a few minutes later. As soon as we arrived at our meeting place, I told my daughter that my face(vaccine side) was also numb: ""like when you get an injection for dental work."" It is now ten hours after I received the vaccine, and the numbness has not seized. It is still there and with a strong tingle sensation. I also feel generally unwell with body aches and weakness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/07/2021,0.0,OTH,,None,"Asthma, GERD, past anemia (have needed blood transfussion)",,"Allergic to eggs. Reaction to morphine, Vicodin, fentanyl (given during hospitalization, effects include: pronounced shortness of Breath, weighted feeling, immobility, etc)","['Asthenia', 'Hypoaesthesia', 'Malaise', 'Pain', 'Paraesthesia']",1,PFIZER\BIONTECH, 1010223,NY,84.0,F,"48 hours after vaccination 2/4/21, diarrhea, followed by extreme, dizziness/lightheadedness, all day., starting 9:30am,2/6/21 Lightheadedness ongoing( day of reporting)2/7/21",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/06/2021,2.0,OTH,"Multi Vitamin, D3, Omega3,B12",None,None,,None,"['Diarrhoea', 'Dizziness']",1,PFIZER\BIONTECH,SYR 1010224,CT,39.0,F,"Immediately after my second injection my left arm below the injection site become painful, hard and extremely swollen. After two days the swollen area became itchy and I have a 4x4 red rash. This did not happen after the first vaccination. I would like to know how long I should expect to have this swelling and rash for and if I should be concerned.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/07/2021,2.0,UNK,None,None,None,Flu vaccine 2020,None,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling']",UNK,MODERNA,IM 1010225,HI,80.0,F,"area of injection on upper left arm (ovoid rash about 6 inches by 3 inches) red and sore and warm (began a few hours after injection and continues now) Headache, body aches, chills and discomfort began a few hours after injection and lasted about one and a half days (totally gone now)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,SEN,multivitamin,none,none,"first moderna covid vaccine shot, 1/7/21, only sore ovoid area around injection site same size but other arm, about one week of ",none known,"['Chills', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site rash', 'Injection site warmth', 'Limb discomfort', 'Pain']",2,MODERNA,SYR 1010226,MD,69.0,F,"Large red area around vaccination site, dark spot in center. Started itching with a rash, burning sensation when I scratched it. Treated with ice pack then an anti-itch cream several times a day. Symptoms lasted approximately 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,02/05/2021,7.0,PUB,Rosuvastatin 10 mg 1Xaday Vitafusion Women's multi vitamin Nature Made D3 5000IU Caltrate 600mg,None,None,,None,"['Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Vaccination site erythema']",UNK,MODERNA,IM 1010227,NJ,86.0,F,"Headache and ""Not feel well"" 2/3/21 4:20AM Nausea, weak, tired, diarrhea 2/3/21 9:56AM Vomited and ""almost"" diarrhea 2/3/21 2:04PM Loose BM and nausea 7:10PM 2/3/21 7:10PM",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/03/2021,1.0,SEN,Cura Med 375mg- Give 1 softgel (375mg) by oral route once daily for Supplement Digest Gold with ATPro Capsule- Give one capsule by oral route with meals as needed for GERD Ginger Tablet- GIve one tablet by oral route daily with meals (6 da,,"HTN, GERD, Hypelipidemia, Pace maker, Major depressive disorder",,amoxicillin; duricef; penicillin; Percocet,"['Asthenia', 'Diarrhoea', 'Fatigue', 'Headache', 'Malaise', 'Nausea', 'SARS-CoV-2 test negative', 'Vomiting']",2,PFIZER\BIONTECH,IM 1010228,AK,66.0,F,"I had been freezing all evening after the shot. Went to bed as usual for the night. Woke up about 1 am which is normal for me. I was still freezing. Got up to go to the bathroom as I normally do. While sitting on the toilet, I started shaking violently - not just regular shivers. This was scary. Violent jerking from the waist up - head, arms, torso. I could not control it. Eventually it stopped. I put on warmer clothes and climbed back into bed. Eventually I warmed up and went to sleep. Other minor side effects were same as the first vaccine - sore and tender around the injection sight and slight headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/05/2021,1.0,OTH,Quetiapine Fumarate 50 mg,None,Depression,,None,"['Dyskinesia', 'Feeling cold', 'Headache', 'Injection site pain', 'Tremor']",2,MODERNA,SYR 1010230,CA,68.0,F,Patient was found unresponsive on 2/5/2021. Brought immediately to Emergency department due to respiratory depression/distress. At this time it is unclear etiology of presentation. However patient is slowly becoming more alert/awake.,Not Reported,,Not Reported,Yes,,Not Reported,Y,02/03/2021,02/05/2021,2.0,PVT,,"chronic pain syndrome , pancreatic mass, type 2 diabetes, hypertension, obesity",,,"Gabapentin, amoxicillin, atropine sulfate, clotrimazole, meloxicam, methotrexate, NSAIDs, penicillins, sulfa class, and zomepirac sodium","['Acidosis', 'Computerised tomogram head', 'Depression', 'Lipase increased', 'Liver function test increased', 'PCO2 increased', 'Respiratory depression', 'Respiratory distress', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH, 1010231,CA,43.0,F,"About 5 days after the 1st Moderna dosage shot, I noticed a rash and it was hot to the touch and itchy. I scratched it and it caused the rash to spread. It was a raised rash and eventually grew to over 4 inches in diameter. At that point, it was no longer itchy but became very painful. It was so painful that my arm started to feel numb and I could hardly move it. The rash was also very hard. I went to urgent care on the evening of January 21 to see Dr. He determined it was cellulitis and prescribed Keflex and Bactrim each for 7 days. After about 2-3 days of antibiotics I started to see the rash decrease in size, pain and hardness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/20/2021,6.0,PVT,daily fish oil supplement,none,none,,none,"['Cellulitis', 'Hypoaesthesia', 'Injection site pain', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 1010232,OK,53.0,F,"Fever 105.4 then 104.6 and 104.0 got the night of shot until 4 days after with chills, headache really bad and weakness fatigue, body and joints aches, no appetite, nauseous essential, saw spots",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,PVT,"Snythroid, allopurinol, jardiance,Lantus solo star, novolin, lomotil, Metformin, Lasix, spirolactone, D3,","Thyroid, crohns, cirrhosis of liver Nash,, spleen, hiatal hernia, gerd, ulcer colitis, arthritis","Crohns disease uc,and cirrhosis, arthritis",,"Sulfa meds, mushrooms, augmentin, Demerol,","['Arthralgia', 'Asthenia', 'Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Visual impairment']",2,MODERNA,SYR 1010233,OR,37.0,F,"Slight arm tenderness first 24 hours, then no adverse effects. However, after 9-10 days, I noticed my arm became extremely itchy at the injection site. Itchiness still persists and there is a red rash that did not form until approx. 10 days after injection. Hesitant to get the second shot as this showed up so long after the shot day that I am wary of a second shot and when this reaction will subside.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,02/05/2021,10.0,OTH,"OTC multi-vitamin and vitamin E, anti histamine for nasal congestion",None,Graves Disease but symptoms were very mild at the time of vaccination,,"Unknown, occasional facial hives but without known cause","['Injection site erythema', 'Injection site pain', 'Injection site rash']",1,MODERNA,SYR 1010235,FL,87.0,F,Stroke. Massive brain bleed right side,Not Reported,,Yes,Yes,3.0,Yes,N,02/05/2021,02/05/2021,0.0,SEN,,,A fib Type 2 diabetes,,None,"['Cerebral haemorrhage', 'Cerebrovascular accident', 'Computerised tomogram']",2,PFIZER\BIONTECH, 1010390,,38.0,F,"Patient received Covid Vaccine Dose 1 (Moderna) on 1/14/2021. 1/15/21 I experienced arm soreness, lethargy, body aches, achy joints, and felt like crap. 1/16/21 I developed two red swollen spots on my left arm (injection arm). The red areas were swollen, hot to touch, and each were a hard lump a little larger than a marble. These two spots were about 3 inches below the injection site and an inch closer to the body midline. These red spots worsened and joined together. 1/28/21 I was still experiencing the red raised area that had grown in size, still hot to the touch and now red and rashy around the outer edge. Redness diminished over the weekend and resolved by 2/3/21. Arm and shoulder still are achy and sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/15/2021,1.0,MIL,None,None,None,Less than a year old. A seizure occurred after the administration of a Pertussis Vaccine in conjuction with Naldecon and Amoxic,"Pertussis, Naldecon, Amoxycillan","['Arthralgia', 'Feeling abnormal', 'Injection site erythema', 'Injection site induration', 'Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Lethargy', 'Limb discomfort', 'Pain']",1,MODERNA,SYR 1010394,,38.0,M,"12 hours after shot, red swollen eyes, fatigue, body ache, tenderness and swelling of left arm. Shortly after chills, fever, swelling of lymph nodes, migraine, rapid heart rate, dizzy, nausea. Lasted about 36 hours. migraine, fatigue, body aches, selling of lymph nodes still present after 48 hours. 72 hours later bruised lymph nodes through out the body (left leg, right upper arm, and right rib cage.) Also noticeable joint and muscle pain. prominently lower back, and right rib cage.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,MIL,none,none,none,,none,"['Arthralgia', 'Back pain', 'Chills', 'Dizziness', 'Eye swelling', 'Fatigue', 'Heart rate increased', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy', 'Migraine', 'Musculoskeletal chest pain', 'Myalgia', 'Nausea', 'Ocular hyperaemia', 'Pain', 'Pyrexia']",2,MODERNA,SYR 1010397,WA,27.0,F,"Moderna COVID-19 Vaccine EUA In addition to arm soreness and headache (which I also experienced following my first dose of the Moderna Covid-19 vaccine), I have a raised, firm, very warm, and red area around the injection site (4inches in diameter). Though the red area is not exactly a circle, the diameter of the red area has steadily increased over the past few days. The area is not itchy. My arm is most painful when I move it (attempting to abduct at the shoulder feels impossible) and I cannot apply pressure (leaning or laying on that arm is also tremendously painful, as is the weight of a blanket touching the arm). My arm soreness after the first dose I received resolved after 5-6 days. My arm was firm and warm around the injection site for that dose, but did not have this red area surrounding the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/03/2021,0.0,PVT,"Lamotrigine, 75mg per day (for epilepsy)",None,Epilepsy,,"Allergies: latex, kiwi, lemongrass, grass, bleach, pine, bee venom","['Headache', 'Injection site erythema', 'Injection site induration', 'Injection site warmth', 'Limb discomfort', 'Pain', 'Pain in extremity']",2,MODERNA,IM 1010401,CA,72.0,F,"Sore arm for several days after the first injection; Mild redness, swelling, and itching at injection site 7 days after first injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/06/2021,7.0,PVT,"Raloxifene, Chlorhexidine gluconate, Eye Promise Restore Vitamins, Multi-vitamins, Calcium, Vitamin C, Magnesium, Ubiquinol CQ-10, Vitamin B6, Vitamin B-12",Runny nose from allergies,"Allergies, Lower back pain",,"Sulfa, Penicillin, Prawns, Pollen","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Limb discomfort']",1,MODERNA,SYR 1010404,,43.0,F,"Fever of 101.6, body aches and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,MIL,Terbinafine Zyrtec Omeprazole Valtrex B12/D3/Iron,"Yes, uterine issues",no,,no,"['Headache', 'Pain', 'Pyrexia']",2,MODERNA,IM 1010485,NY,,M,"acute optic neuritis; A spontaneous report was received from a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced acute optic neuritis. The patient's medical history was not provided. No relevant concomitant medications were provided. On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 011L20A) in the left arm intramuscularly for prophylaxis of COVID-19. On 08 Jan 2021, the day after administration, the patient stated he started to develop an adverse reaction that eventually culminated in acute optic neuritis. He mentioned that he was unsure if the vaccine caused it. He had a CT scan, MRI scan and lumbar puncture with results pending. He also stated that every diagnosis that could cause optic neuritis came back negative. The only change was receiving the vaccine before his symptoms started. On 22 Jan 2021, the patient reported his eye was getting better, but his vision was still not fully repaired. Treatment for the event included prednisone. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the event, acute optic neuritis, was unknown. Follow-up received on 22 Jan 2021 included: update the reporter address, lot number, treatment and status of event.; Reporter's Comments: This case concerns a male patient who received their first of two planned doses of mRNA-1273 (Lot 011L20A), and who experienced the serious unlisted event of acute optic neuritis. Based on the current available information and temporal association between the use of the product and the onset of event on the day after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/08/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Computerised tomogram', 'Lumbar puncture', 'Magnetic resonance imaging', 'Optic neuritis', 'Visual impairment']",1,MODERNA,OT 1010486,IL,,F,"The vaccine was administered to the patient with a subq needle; A spontaneous report was received from a pharmacist concerning 65-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) administered with a 5/8-inch (subcutaneous) needle. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot#026L20A) for prophylaxis of COVID-19 infection. On an unknown date, the patient was administered a vaccine using a 5/8-inch (subcutaneous) needle. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine administered with a 5/8-inch (subcutaneous) needle, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of needle issue for mRNA-1273, lot # 026L20A. There were no reported AEs associated with this case of needle issue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Wrong technique in product usage process'],1,MODERNA,OT 1010487,IL,,M,"The vaccine was administered to the patient with a subq needle; A spontaneous report was received from a pharmacist concerning 66-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) which was administered with a 5/8-inch (subcutaneous) needle. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received his first of two planned doses of mRNA-1273 (Lot number 026L20A) for prophylaxis of COVID-19 infection. On an unknown date, the patient was administered a vaccine using a 5/8-inch (subcutaneous) needle. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine administered with a 5/8-inch (subcutaneous) needle, was considered recovered/resolved.; Reporter's Comments: This case concerns 66 year old male patient who received his first of two planned doses of mRNA-1273 (Lot number 026L20A) for prophylaxis of COVID-19 infection while using a 5/8-inch (subcutaneous) needle. There were no reported adverse events after the vaccine was administered in this case of need issue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Wrong technique in product usage process'],1,MODERNA,OT 1010489,NM,56.0,F,"itchy sensation to arms; redness to chest; This is a spontaneous report from a contactable pharmacist. A 56-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number EL1284, intramuscular in left arm, on 21Dec2020 at12:30 ( at the age of 56 years old) as a single dose for COVID-19 immunization. Medical history included asthma, hyperlipidemia, PTSD, and seasonal allergies. Concomitant medications were not reported. The patient previously took acetylsalicylic acid (ASPIRIN) (rash), ciprofloxacin, codeine (vomiting, rash), escitalopram (dizziness, rapid heart rate). Prior to the vaccination the patient was not diagnosed with COVID-19. The COVID-19 vaccine was administered at a hospital. There were no other vaccines within four weeks prior to the vaccination. On 21Dec2020 at 12:30, the patient experienced itchy sensation to arms, redness to chest. Rapid response was called, patient monitored. No additional intervention, no treatment provided. The outcome of the events was recovered. The patient was not tested for COVID-19 post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/21/2020,0.0,PVT,,,Medical History/Concurrent Conditions: Asthma; Hyperlipidemia; Post-traumatic stress disorder; Seasonal allergy,,,"['Erythema', 'Pruritus']",1,PFIZER\BIONTECH,OT 1010491,GA,,F,"nausea; extreme fatigue/tiredness; left arm very sore and achy, it became very stiff; left arm very sore and achy, it became very stiff; body aches increased; body aches increased; headaches on and off; chills; night sweats really bad for two nights; light fever; nose running; light cough; This is a spontaneous report from a contactable consumer who reported for herself. A 58 (units unknown) non-pregnant adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: E10140) via an unspecified route of administration on 14Jan2021 as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure (High blood pressure-take medication, heart medicine also) from an unspecified date and unspecified if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date and unspecified if ongoing. It was reported that the patient had no known allergies. Concomitant medications were not reported. It was reported that the patient had not taken other medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Jan2021 at 17:30 (reported as ""on Friday after the first dose"") the patient experienced nausea, extreme fatigue, left arm very sore and achy, it became very stiff, body aches increased, headaches on and off, chills and night sweats really bad for two nights, tiredness, light fever, nose running and light cough. The clinical outcome of the events nausea, extreme fatigue, left arm very sore and achy, it became very stiff, body aches increased, headaches on and off, chills and night sweats really bad for two nights, tiredness, light fever, nose running and light cough were all recovering/resolving. It was reported that no treatment was received for the adverse events. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/15/2021,1.0,UNK,,,"Medical History/Concurrent Conditions: Blood pressure high (High blood pressure-take medication, heart medicine also); COVID-19 (Prior to vaccination: Yes); Heart disorder (High blood pressure-take medication, heart medicine also)",,,"['Chills', 'Cough', 'Fatigue', 'Headache', 'Limb discomfort', 'Musculoskeletal stiffness', 'Night sweats', 'Pain', 'Pain in extremity', 'Pyrexia', 'Rhinorrhoea']",1,PFIZER\BIONTECH, 1010513,MA,31.0,F,"Acute appendicitis; This is a spontaneous report from a contactable physician reporting for herself. A 31-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK4176), intramuscular in the left arm, on 16Jan2021 at 18:30, at single dose, for COVID-19 immunisation. Medical history included iron deficiency anaemia, migraine and drug allergy to amoxicillin. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included multivitamin and ferrous sulfate (unknown manufacturer). Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), on 26Dec2020 at 04:15 PM, intramuscular in left arm for COVID-19 immunisation. The patient experienced acute appendicitis on 20Jan2021 at 09:00 with outcome of recovering. The patient went to the emergency room and was hospitalized due to the event in Jan2021 for 1 day. Therapeutic measures were taken as a result of the event and included laparoscopic appendectomy. The patient underwent lab tests and procedures which included COVID-19 PCR test (nasal swab): negative on 20Jan2021.; Sender's Comments: Given the nature of the medical condition and the overall clinical picture, the event appendicitis is most likely an intercurrent medical condition and is assessed as unrelated to bnt162b2. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/16/2021,01/20/2021,4.0,PVT,FERROUS SULFATE,,Medical History/Concurrent Conditions: Drug allergy (To amoxicillin); Iron deficiency anemia; Migraine,,,"['Appendicectomy', 'Appendicitis', 'Laparoscopic surgery', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,OT 1010525,AZ,70.0,F,"due to get the 2nd dose, but she tested positive for COVID yesterday; due to get the 2nd dose, but she tested positive for COVID yesterday; Dizzy; starting to get foggy; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899 or EH9897), via an unspecified route of administration at the left arm on 04Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing diabetic, blood pressure high, high cholesterol and sore arms from previous vaccines (unspecified).She had energy for a whole week after getting the vaccine, that she has not had for a long time, she even cleaned out her whole garage; has been waiting to do that for 3 years; had to make herself stop to rest. There were no concomitant medications. The patient got her first dose on 04Jan2021 and was due to get the 2nd dose this coming 25Jan2021, but she tested positive for COVID on 21Jan2021. She has been sick for a week which started with an irritating cough on 14Jan2021. She went to the ER because she was dizzy as could be on Jan2021. She does not remember which day; she was starting to get foggy on Jan2021. She was not admitted. She did a drive through rapid test on 21Jan2021 and it was positive. Lot numbers: Handwriting on her card was bad and she cannot tell if the last digit of the Lot number is a 9 or 7. The vaccine was administered in an open tent clinic outside in a parking lot outside a hospital and not in a military facility. The outcome of the event was unknown. Information on Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/01/2021,,UNK,,Diabetic,Medical History/Concurrent Conditions: Blood pressure high; High cholesterol; Pain in arm,,,"['Blood cholesterol increased', 'COVID-19', 'Cough', 'Dizziness', 'Feeling abnormal', 'Hypertension', 'Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010528,NY,32.0,F,"unfortunately she had a miscarriage about 5-6 days before her second dose; positive pregnancy test a few days after the first dose.; positive pregnancy test a few days after the first dose.; This is a spontaneous report from a contactable consumer. A 32-year-old female patient (3 weeks pregnant at time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on left arm on 31Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included iron and minerals nos, vitamins nos (PRENATAL VITAMINS). The patient had a negative pregnancy test in 2020 before getting the first vaccine dose, but then had a positive pregnancy test in Jan2021 a few days after the first dose, but unfortunately she had a miscarriage in Jan2021, about 5-6 days before her second dose. She has an appointment scheduled with OBGYN for the miscarriage. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the miscarriage was recovering.; Sender's Comments: Based on the temporal relationship, the association between the event miscarriage with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,PVT,IRON; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS],,,,,"['Abortion spontaneous', 'Exposure during pregnancy', 'Pregnancy test positive']",1,PFIZER\BIONTECH, 1010547,,,U,"covid test came back positive; covid test came back positive; This is a spontaneous report from a contactable other hcp (patient). The patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 17Dec2020 (first dose) and 07Jan2021 (second dose) at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported ""I am a healthcare professional and I have had both doses of the vaccine (17Dec and 07Jan). I was scheduled for surgery this past Wednesday but it was cancelled as my covid test came back positive. I have no symptoms. I was advised to get antibody testing. This showed I have antibodies for both IgG and IgM. I was still told I cannot have the surgery. "" The outcome of the events was unknown. No follow-up attempts are possible, information on batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/01/2021,,UNK,,,,,,"['Asymptomatic COVID-19', 'SARS-CoV-2 antibody test positive', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 1010561,,,F,"Caller stated that she tested positive for the Covid Virus after she received her first dose of the vaccine; Caller stated that she tested positive for the Covid Virus after she received her first dose of the vaccine; This is a spontaneous report from a contactable consumer reporting for the mother. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller, calling on behalf of mother, wanted to know if she should receive her second vaccine today while positive for the Covid Virus. Caller stated that she tested positive for the Covid Virus after she received her first dose of the vaccine. The outcome of the events was unknown. Information on lot number/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010562,,85.0,F,"a person who has received the covid vaccine but tested positive to the infection; a person who has received the covid vaccine but tested positive to the infection; This is a spontaneous report from a contactable pharmacist. This pharmacist reported that an 85-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) intramuscular at single dose on 21Jan2021 for COVID-19 immunisation. The patient received the first dose on unknown date. Relevant history and concomitants drugs were not reported. Per reporter, the patient was not seeing anything crazy on her chart. The patient got the second dose of the COVID vaccine on 21Jan2021. On 22Jan2021, she had been tested positive for COVID-19 (COVID-19 Rapid test). The patient had cough and low grade fever since unknown date. Relevant test was none. Outcome of event was unknown. The nurse practitioner wanted to do a monoclonal antibody infusion and the pharmacist was wondering if they could do that? When probed for causality, the pharmacist responded: ""I guess not I'm not going to comment on that, I don't know. I don't have the patient's actual file."" Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the second vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/22/2021,,OTH,,,,,,"['COVID-19', 'Cough', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,OT 1010569,PA,52.0,F,"Feeling tired; Discovered she was Covid 19 positive; Discovered she was Covid 19 positive; This is a follow-up spontaneous report from a Pfizer-sponsored program Pfizer. A contactable consumer reported that a 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunisation. Medical history included Allergies from an unknown date and unknown if ongoing, bad back aches from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]), mometasone furoate (FLONASE [MOMETASONE FUROATE]). On 16Jan2021, she had her first dose of COVID vaccine, and two hours later she had a positive COVID test done. She is wondering when she can get the second dose, her doctor said she had to wait 3 months for the second, dose, she is questioning that, and wants to know, should she be retested for COVID, since she thinks it may be a false positive, since she has no symptoms of COVID. She states she didn't really have any symptoms other than feeling tired. The outcome of event fatigue was unknown, while the outcome of the other events was not resolved. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/16/2021,1.0,UNK,ADVIL [IBUPROFEN]; FLONASE [MOMETASONE FUROATE],,Medical History/Concurrent Conditions: Allergy; Back ache,,,"['COVID-19', 'Fatigue', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010590,TX,84.0,F,"tested positive for covid; tested positive for covid/Nasal Swab: positive; This is a spontaneous report from a contactable nurse. An 84-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included Alzheimer's disease, cough (she has had a cough forever), cellulitis, constipation, dementia, depression, appendicectomy, and right hip replacement surgery. The patient's concomitant medications were not reported. The patient experienced tested positive for COVID on 13Jan2021. The patient underwent lab tests and procedures which included Nasal Swab: positive on 13Jan2021. The reporter was calling for information about administration of the COVID vaccine at an interval greater than the 21 days and recommendations for a patient who tested positive after the first dose of the vaccine. The patient got the first dose of the COVID vaccine on 05Jan2021, She tested positive for COVID on 13Jan2021 and then next time she will be seen and tested will be 15Feb2021. Due to this it seems like they can't give her the vaccine this following Monday because she tested Positive and the Next time, the clinic gets vaccines is on 15Feb2021, Caller asks is that too long of a time frame for the second Dose. Or would they have to start over on 15Feb2021 with another first dose. The First Dose was on 05Jan2021. The Positive Covid Test was on 13Jan2021, it was done by a Nasal Swab. Patient won't be due for another COVID test for 14 days after, she is due for her next COVID test on 27Jan2021. If she is Negative on the 27Jan2021, then she will get her next COVID Vaccine on 15Feb2021. This is non-serious report. The outcome of events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), on 05Jan2021, and COVID-19 test, including Nasal Swab, positive on 13Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID 19 test likely represents a pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/13/2021,8.0,OTH,,,Medical History/Concurrent Conditions: Alzheimer's disease (Verbatim: Alzheimer's disease); Appendectomy; Cellulitis; Constipation; Cough (She has had a cough forever/Verbatim: Cough); Dementia; Depression; Hip replacement,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010591,OH,,M,"tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program . The male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 04Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. He received the Pfizer BioNTech COVID-19 vaccine on 04Jan2021 and tested positive for COVID-19 on 11Jan2021. He said he is already back to work and is scheduled for the second dose on 25Jan2021. He asked if he should go forward with the scheduled dose or should he wait 6 more weeks for the second dose. The outcome of the events was unknown. No follow-up attempts are possible, information on batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/11/2021,7.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010594,MO,55.0,F,"symptoms of COVID/ believes it could be COVID; symptoms of COVID/ believes it could be COVID; terrible diarrhea; constant headache; Gas; Bloating; Her arm was sore for 24 hours; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL8982, unknown expiration), via injection once to right arm on 14Jan2021 at a single dose as she is eligible with first tier for vaccination. Medical history and concomitant medications reported as none. The patient reported that she received the first dose of COVID vaccine on 14Jan2021 (Thursday). The next day (15Jan2021), her arm was sore for 24 hours after the shot, and she didn't have any side effects over the weekend. On 19Jan2021, Tuesday, she started having constant headache, and was experiencing problems with gas and bloating, it is very rare for her to have this issue, and it was building the last of couple days, she was uncomfortable and was taking over the counter medication for relief. She was keeping the headaches at bay with generic ibuprofen (lot: S200378, expiry: Mar2023), but if she missed a dose or is feeling better and doesn't take, it is coming back, it is consistent. Gas and bloating are primarily after eating, on Wednesday, after 24 hours it was ridiculous. She got some generic Extra Strength Gas Relief one tablet after eating (lot: 75257, expiry: Jun2022), and it was giving her some relief until early this morning. Tuesday, Wednesday, and Thursday, the gas and bloating was worse. Last night, her entire chest, she wanted to burp so bad, but couldn't because it really hurt, and it took a while for the next tablet to kick in and give relief, she was like where is this coming from, she didn't know it could build up so much. On 22Jan2021, she had a terrible diarrhea. Diarrhea was painful and intense, she took generic Pepto Bismol 1-2 tablets, and she took 4, The first time she woke up at 04:30 AM and at 7 another wave hit her, so she took another two tablets. Right now, she is feeling okay, but the gas is building up, her chest is filling, she is uncomfortable. The patient asked if these are reported side effects. She works in a dental office, and the doctor is knowledgeable and sensitive to COVID, and even though those symptoms are not listed as side effects on the information sheet, the doctor said they are symptoms of COVID, and even though those symptoms are not listed as side effects on the information sheet, the doctor said they are symptoms of COVID, are these side effects or may she have COVID, though she doesn't know who she could have gotten COVID from. Out of protection for patients at dental clinic, the HCP at clinic wants her to get the COVID test as he believes it could be COVID and not side effect of the vaccine. She doesn't want to quarantine for nothing if it is just side effects of the vaccine. She will be getting rapid diagnostic for COVID and not the antibody test. She thinks she should get tested, but there is no testing appointment available until tomorrow, and she does not want to self-quarantine needlessly, she will live through it, she is happy to get the test, but she doesn't want to lose 2 weeks of pay if others are reporting the same side effects. She was happy to get the vaccine. The patient recovered from the event arm sore on 16Jan2021; not yet recovered from events constant headache, gas, and bloating; while unknown outcome for the remaining events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/15/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Abdominal distension', 'Chest discomfort', 'Chest pain', 'Condition aggravated', 'Diarrhoea', 'Discomfort', 'Dyspepsia', 'Flatulence', 'Headache', 'Pain in extremity']",1,PFIZER\BIONTECH, 1010597,IL,62.0,M,"Intense pain to R foot within 12 hours; This is a spontaneous report from a contactable other HCP (patient). A 62-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), via an unspecified route of administration on 29Dec2020 10:30 at SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, type 2 diabetes mellitus, cerebrovascular accident, Penicillin allergy. The patient experienced intense pain to R foot within 12 hours on 30Dec2020 01:30 with outcome of recovered with sequelae. Treatment received for the adverse event included: MRI, Ultrasound, Interventional radiology. The patient was hospitalized for intense pain to R foot within 12 hours for 9 days. The patient underwent lab tests and procedures which included Interventional radiology, magnetic resonance imaging, Nasal Swab test: negative, ultrasound scan.; Sender's Comments: The 62-year-old male patient had medical history included hypertension, type 2 diabetes mellitus and cerebrovascular accident. The reported intense pain to R foot was more likely due to intercurrent condition/disease, and less likely causally related to the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information, including MRI and Ultrasound findings and Interventional radiology details, become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,9.0,Not Reported,N,12/29/2020,12/30/2020,1.0,PVT,,,Medical History/Concurrent Conditions: CVA (CVA X2 (5yrs)); Hypertension (HTN); Penicillin allergy (Allergies to medications/or other products:PCN); Type II diabetes mellitus (Type II DM),,,"['Magnetic resonance imaging', 'Pain in extremity', 'Ultrasound scan', 'Viral test negative']",1,PFIZER\BIONTECH, 1010598,NC,26.0,F,"mental confusion; inability to speak/tried to say things and it was a jumbled, meaningless string of words; felt very cold; tingling around the mouth; aura like a bad migraine; bright spotty vision in the peripheral right field; bright spotty vision in the peripheral right field; thought she was having a stroke; EKG showed peaked T waves, common with dehydration and high potassium; EKG showed peaked T waves, common with dehydration and high potassium; EKG showed peaked T waves, common with dehydration and high potassium; likely a severe migraine; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK9231, expiration date was unknown), intramuscularly on the left arm on 30Dec2020 at 14:45 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the workplace clinic. Relevant medical history included COVID-19, which was diagnosed prior to vaccination and migraines (before). The patient had no allergies to medications, food, or other products. Concomitant medication included melatonin. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 at 15:45 or 1 hour after the vaccine injection, the patient had an aura like a bad migraine and she had bright spotty vision in the peripheral right field for 15-20 minutes; the patient has had migraines before, but they're not common for her. Two hours after the vaccine, on 30Dec2020 at 16:45, the patient had mental confusion and an inability to speak; she tried to say things to her husband and it was a jumbled, meaningless string of words. She also felt very cold and she had tingling around the mouth. Her husband thought she was having a stroke and called 911 on 30Dec2020. All her vitals were stable, and within 10 minutes she could speak again. On 30Dec2020, the patient's electrocardiogram (EKG) showed peaked T waves, common with dehydration and high potassium. She was encouraged to go to the emergency room (ER). Instead of taking the ambulance, she drove herself several hours later. The patient wanted someone to tell her it wasn't a stroke. After a brief neurological exam on 30Dec2020, the doctor said it was likely a severe migraine and wrote the reason for her visit as a vaccine reaction. This took place in the late evening to early morning, and she missed one day of work. The events did result in an emergency room/department or urgent care visit. The reporter assessed the events as non-serious. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered from all the events on 31Dec2020.; Sender's Comments: Based on the close temporal relationship, the association between the event stroke with BNt162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,MELATONIN,,Medical History/Concurrent Conditions: COVID-19 (diagnosed prior to vaccination); Migraine (before),,,"['Aphasia', 'Condition aggravated', 'Confusional state', 'Disorganised speech', 'Electrocardiogram T wave peaked', 'Feeling cold', 'Impaired work ability', 'Migraine', 'Migraine with aura', 'Neurological examination abnormal', 'Paraesthesia oral', 'Visual impairment']",1,PFIZER\BIONTECH,OT 1010602,TN,46.0,F,"tested positive with COVID PCR tests; tested positive with COVID PCR tests; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient (pharmacist colleague) received the first does of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EJ1685, Expiration Date: Mar2021), via an unspecified route of administration at site of left arm at 11:45 on 27Dec2020 at single dose for covid-19 immunization. Medical history included was none. There were no concomitant medications. There were no other vaccinations given recently, or no new medications. The patient experienced tested positive with COVID PCR tests on 28Dec2020 (also reported 24 hours - 48 hours after getting the vaccine). Clinical: After the first dose of vaccination, the patient had no symptoms, she had been routinely screened prior and was negative, then tested positive 24 hours after receiving vaccination on 29Dec2020. they did another one on 29Dec2020 and on 30Dec2020 that were negative. Event was assessed as non-serious since patient had no symptoms. After the second dose, the patient did not test positive, and after the second one they did a little study. The patient underwent another lab tests and procedures which included CT value: 24 on 28Dec2020.; Sender's Comments: Based on the current available information, Drug ineffective and COVID-19 PCR test positive are unlikely related to BNT162B2 vaccine. The event occurred two day after vaccination, when vaccine was not expected to achieve the effect. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/27/2020,12/28/2020,1.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'Computerised tomogram', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010604,MI,39.0,F,"cellulitis in arm; Dizzy head; sore; a few lymph nodes reacted; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknown date in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if patient was pregnant. The patient received the first dose of BNT162B2 (lot number: EL0140) on 28Dec2020 for covid-19 immunization. On an unknown date in Jan2021, the patient experienced Dizzy head and sore. Then injection site swelling and was hot to the touch and a few lymph nodes reacted. Two days of 102+ fever, diagnosis of cellulitis in arm. Antibiotics received for cellulitis. Adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['Cellulitis', 'Dizziness', 'Injection site swelling', 'Injection site warmth', 'Lymphadenopathy', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1010608,,,M,"10 days ago I developed the virus; 10 days ago I developed the virus; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that he had the first Pfizer COVID vaccine dose and he was scheduled to get the 2nd dose on 25Jan2021. He reported that 10 days ago (12Jan2021) he developed the virus. The patient asked if he should wait longer to get his 2nd dose. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/12/2021,,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 1010619,AZ,34.0,F,"tested positive for covid 19/it was a swab in her nostrils; tested positive for covid 19/it was a swab in her nostrils; This is a spontaneous report from a contactable consumer reporting for self. This 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 06Jan2021 around 14:30-14:45 at left arm at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. No prior vaccinations within 4 weeks and no AEs follow prior vaccinations. Family medical history included diabetes. The patient received 1st dose of vaccine on 06Jan2021, tested positive for COVID 19 on 19Jan2021. Unable to provide which COVID test she received. Stated she was tested at (Pharmacy) and it was a swab in her nostrils. She was scheduled for 2nd dose on 27Jan2021 at 15:45 and asking if she can/should get the 2nd dose. The outcome of event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/19/2021,13.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010624,NC,49.0,M,"Peripheral facial paralysis (Bell's Palsy) left side 8 days after vaccination; This is a spontaneous report from a contactable 49-year-old male other healthcare professional (HCP) (patient) reported for himself received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via unspecified route on left arm single dose for COVID-19 immunization on 09Jan2021, 02:30 PM, at 49-year-old. Medical history included: Borderline Type 2 diabetes; Hepatitis B carrier. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: metformin, entecavir. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2. The patient had peripheral facial paralysis (Bell's Palsy) left side 8 days after vaccination (17Jan2021) and was reported as non-serious. Treatment was received as steroids and antiviral. Emergency room/department or urgent care visited. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the event was not resolved.; Sender's Comments: Based on currently known drug safety profile, a causal association between the reported event peripheral facial paralysis and BNT162B2 cannot be fully excluded. The event facial paralysis can also be caused by other virus infection. Case will be reassessed when additional information is available including viral testing. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/17/2021,8.0,SCH,METFORMIN; ENTECAVIR,,Medical History/Concurrent Conditions: Hepatitis B carrier; Type 2 diabetes mellitus,,,['Facial paralysis'],1,PFIZER\BIONTECH, 1010628,,84.0,F,"She tested positive on 20Jan and is currently asymptomatic; She tested positive on 20Jan and is currently asymptomatic; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program. The 84-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EL1283), via an unspecified route of administration on 13Jan2021 at SINGLE DOSE as Preventive and healthcare worker. Medical history and concomitant medications were none. Caller received the first dose of the vaccine on 13Jan. She tested positive on 20Jan and is currently asymptomatic. Her next dose of the vaccine is due on 29Jan and wants to know if she should get this at a later date. The outcome of the events was not recovered. No follow-up attempts are possible, information on batch number cannot be obtained.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/20/2021,7.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010635,MO,64.0,F,"Severe lower stomach cramps; diarrhea; some bloody stool; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 64-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL32495-21), via an unspecified route of administration at Left arm on 20Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included allergies to penicillin, allergies to Latex and allergies to shellfish. Concomitant medication included rosuvastatin calcium (CRESTOR), raloxifene hydrochloride (EVISTA), tramadol, ibuprofen 600 mg received within 2 weeks of vaccination. The patient previously took iodine and experienced allergies to Iodine, codeine and experienced allergies to codeine, oxytetracycline (TERRAMYCIN) and experienced allergies to Terramycin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe lower stomach cramps and diarrhea since 22Jan2021 19:30 and still having this issue to include some bloody stool on 22Jan2021 12:30. No treatment received for the events. The events were reported as non-serious. The patient was not pregnant. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/22/2021,2.0,PUB,CRESTOR; EVISTA; TRAMADOL; IBUPROFEN,,Medical History/Concurrent Conditions: Latex allergy; Penicillin allergy; Shellfish allergy,,,"['Abdominal pain upper', 'Diarrhoea', 'Haematochezia']",1,PFIZER\BIONTECH, 1010637,IN,74.0,F,"Couldn't hold a cup to drink; Pharangitis; Couldn't get warm; Strange odor in her nose, like burning plastic; Taste started to diminish; Painful bilateral lower back pain; Cough/Dry cough; Bad headache; Severe shaking chills; Muscles and joints ached; Muscles and joints ached; This is a spontaneous report from a contactable nurse (patient). A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration at left deltoid on 20Jan2021 at 9:30-9:45 am at SINGLE DOSE for COVID-19 immunization. Medical history included exposure to radiation from 2017 to an unknown date and did lose some of her sense taste due to 2 massive doses of radiation in 2017). There were no concomitant medications. Historical vaccine included two doses of shingles vaccine (SHINGRIX) for Immunization and experienced shaking, chills, and muscle and joint pain after the vaccine. The patient experienced bad headache (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, Severe shaking chills (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, muscles and joints ached (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, couldn't hold a cup to drink on an unspecified date with outcome of unknown, painful bilateral lower back pain on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, cough/dry cough on 20Jan2021 17:00 with outcome of not recovered (reported as worsened), strange odor in her nose, like burning plastic on 21Jan2021 with outcome of not recovered, taste started to diminish on 21Jan2021 with outcome of not recovered, pharangitis on an unspecified date with outcome of unknown, couldn't get warm on an unspecified date with outcome of unknown. Details were as follows: the patient received the COVIED in the morning of 20Jan2021. By 5pm she had developed a headache, severe shaking, chills, muscle and joints pain, severe lower back pain, and a dry cough; she was miserable. A few years ago after her double dosing of the shingles vaccine she had a similar reaction of shaking, chills, and muscle and joint pain. She has no product details for that product, no NDC, Lot, or expiry to provide. The patient confirmed that the shingles shot was 2 doses, not a double dose given at one time. When asked a seriousness criteria it was explained that the symptoms that started on the 20th, she felt they were disabling. She couldn't get warm, stop shaking, couldn't hold a cup and the pain was severe and she has high tolerance for pain. By around 3pm that day on the 21Jan2021 everything but the dry cough had resolved, and that had gotten worse. She also developed new symptoms. She had strange odor in her nose, like burning plastic and her sense of taste started to diminish. She did lose some of her sense taste due to 2 massive doses of radiation in 2017, She has no product information, NDC, Lot or Expiry for that radiation but after that she did have taste, some of it did come back. On the 21Jan2021, it was less, the sense of taste and now today she has no taste at all. For the muscle and joint pain she took Aleve. She was told if she was feeling worse over the weekend to go to the ER or urgent care. The patient was wondering and thinking this was her normal response to the vaccine just like she had a normal response that shingles vaccine.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/20/2021,01/20/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Loss of taste (She did lose some of her sense taste due to 2 massive doses of radiation in 2017); Radiation exposure (She did lose some of her sense taste due to 2 massive doses of radiation in 2017),,,"['Ageusia', 'Arthralgia', 'Back pain', 'Chills', 'Condition aggravated', 'Cough', 'Feeling abnormal', 'Grip strength decreased', 'Headache', 'Myalgia', 'Nasal odour', 'Parosmia', 'Pharyngitis', 'Tremor']",1,PFIZER\BIONTECH, 1010638,MO,48.0,F,"no detectable antibodies to the spike protein 2 weeks after the second vaccine; no detectable antibodies to the spike protein 2 weeks after the second vaccine; This is a spontaneous report from a contactable physician (patient) reported for herself that a 48-year-old female patient received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on an unspecified date at single dose (Batch/lot number: EL1284), and second dose via intramuscular on an unspecified date in Jan2021 at single dose (Batch/lot number: EH9899) for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. Physician previously received a Hepatitis B vaccine that is a 3-dose series when it came out in the 90s. She received her 3 doses and with her 3-year titer, she did not make enough antibodies with 3 shot, so they gave her the 4th shot and the 5th shot as well since she still did not make enough antibodies. After the 5th dose, she did not convert so they told her she does not need to take any more doses. Physician had both Pfizer COVID vaccine doses 3 weeks and 2 days apart. After 13 and a half days, she went to check for antibody response and had no antibody response/no detectable antibodies using the spike antibody test from (diagnostic center) new quantitative test (the test stated she was nonreactive). Physician also stated she had no symptoms when she received the COVID 19 shot. Patient said she took the standard dose what is it ""50, 130-10."" She stated the antibodies should form as result of the Covid vaccine. Physician had the Pfizer Covid Vaccine and the booster and went 13 and half days later and had her spike protein drawn through the '(diagnostic center) lysis' and how they say this lab because she was the slow converter and she has no detectable antibodies for spike protein at 14 days post second shot, somebody just needs to know that and she needs to know should she takes the J and J vaccine or do she get the booster like she did with these, what happens and to just give you the whole symptomatology, she had no symptoms with her shot. Her daughter is on trial for the 12-15 year old her daughter received the chills probable node underneath the arm on the side her daughter had the vaccine and so even though her daughter is bonded (AER#2021107312), physician is 99% sure she got it, physician was a non-converter until the fifth shot of the Hep-B vaccine in the 90's. Physician wondered what that means. If she should get a third shot and if she should try a different vaccine type once available. If she should be taking a different test than the spike antibody test from (diagnostic center) if she did not have an antibody response. Physician asked if Pfizer has any data regarding participants who received the vaccine not having an immune response following 2 doses of vaccination. She asked if Pfizer is starting to collect a database on those that have not received an antibody response to the vaccine. She wanted to provide information to our database regarding no antibody response to the COVID vaccine and asked if she can get the Luminex immunoassay test that was done in the Phase 1 clinical trial in (city). Her daughter is in the clinical trial for ages 12 to 15 and she knows they draw her blood there. Physician asked if somebody can draw her blood there to test for antibodies. Outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 antibody test negative and suspected LOE due to temporal relationship. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,OTH,,,,,,['SARS-CoV-2 antibody test negative'],1,PFIZER\BIONTECH,OT 1010639,MI,75.0,F,"accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; continues to have muscle pain; weakness; shortness of breath when she walks; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 16Jan2021 04:00, she went to bed at night and woke up at 4 AM with a severe headache. She took Aleve and went back to bed. When she woke up at 8:30 AM her headache was very severe and was accompanied with very severe chest pain. She immediately took her to the ER. They did a very thorough work up to check on her heart and Aorta. They managed her severe pain with two doses of morphine followed by two days of Dilaudid. The imaging and symptoms left her with a newly discovered diagnosis of Pericarditis. The medical professions were sure this was a result of the COVID vaccine. They continued to treat her for a few days and sent her home with anti inflammatories to help. She continues to have muscle pain, weakness and shortness of breath when she walks. She is scheduled to take her 2nd dose on February 5th but we are very concerned and hesitant as we don't want to cause any more damage to her heart. The patient was hospitalized for events 'headache', 'chest pain;', 'pericarditis' and 'pain' for 4 days. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not received any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included imaging: pericarditis on 16Jan2021 and Nasal Swab: negative on 16Jan2021. Therapeutic measures were taken as a result of all the events which included Colchicine and prednisone, morphine and dilaudid. The outcome of the events was recovering. The events ""headache"", ""chest pain"", ""pericarditis""and ""severe pain"" were assessed as serious due to hospitalization and disability. The events ""myalgia"", ""asthenia"" and ""dyspnea"" were assessed as serious due to disability. The events ('headache', 'chest pain;', 'pericarditis' and 'pain') resulted in emergency room visit. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,4.0,Yes,N,01/15/2021,01/01/2021,,PUB,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Cardiac imaging procedure abnormal', 'Cardiovascular evaluation', 'Chest pain', 'Dyspnoea', 'Headache', 'Myalgia', 'Pericarditis', 'SARS-CoV-2 test negative', 'Sleep disorder']",1,PFIZER\BIONTECH, 1010644,GA,21.0,M,"Trouble breathing; Lightheaded/dizzy; Chills; Sore all over; Weakness in legs; Chest pain; This is a spontaneous report from a contactable consumer (patient). This 21-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 12Jan2021 at a single dose on the left arm for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. No known allergies. Pre-vaccination COVID test was not performed. On 13Jan2021, at 05:00 PM, the patient had lightheaded/dizzy, chills, sore all over, weakness in legs, chest pain and trouble breathing. On 14Jan2021, COVID test (Nasal Swab) was done and resulted negative. The events required an emergency room visit. Then, the patient was hospitalized for 3 days due to the events. Therapeutic measures taken as result of the events included ibuprofen and 2 other medications. The patient was recovering from the events.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/12/2021,01/13/2021,1.0,UNK,,,,,,"['Arthralgia', 'Chest pain', 'Chills', 'Dizziness', 'Dyspnoea', 'Muscular weakness', 'Pain', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH, 1010645,PA,66.0,F,"contracted Covid after my 2nd dose, 3 days to be exact; contracted Covid after my 2nd dose, 3 days to be exact; This is a spontaneous report from a contactable other health professional (patient). A 66-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Lot # EL3246) at single dose at right arm on 14Jan2021 for covid-19 immunisation, administered at hospital. Medical history included rheumatoid arthritis, allergies to morphine and related, PCN, sulfa, quinidine, Xeljanz. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included: upadacitinib (RINVOQ), folic acid (FOLIC ACID), ropinirole hydrochloride (REQUIP). The patient previously received the 1st dose of bnt162b2 (BNT162B2, Lot # EJ1685) at single dose at right arm on 26Dec2020 03:00 PM for covid-19 immunisation, administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced contracted Covid after her 2nd dose, muscle aches and fatigue 3 days to be exact on 17Jan2021 17:00, Covid test result positive on 22Jan2021. Since the vaccination, the patient has been tested for COVID-19 (nasal swab): positive on 22Jan2021. No treatment was received for the adverse event. The outcome of Covid test result positive was unknown, of the other events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported lack of efficacy cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/17/2021,3.0,PVT,RINVOQ; FOLIC ACID; REQUIP,,Medical History/Concurrent Conditions: Penicillin allergy (PCN allergy); Rheumatoid arthritis (Rheumatoid); Sulfonamide allergy (sulfa allergy),,,"['COVID-19', 'Fatigue', 'Myalgia', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 1010646,VA,,U,"testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 1st of 14 reports. An elderly patient (more than 65 years old) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021 with outcome of unknown. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab (drug being administered under FDA EUA). The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021065206 same reporter/drug/event, different patient.;US-PFIZER INC-2021065202 same reporter/drug/event, different patient.;US-PFIZER INC-2021065199 same reporter/drug/event, different patient.;US-PFIZER INC-2021065208 same reporter/drug/event, different patient.;US-PFIZER INC-2021065203 same reporter/drug/event, different patient.;US-PFIZER INC-2021065200 same reporter/drug/event, different patient.;US-PFIZER INC-2021065205 same reporter/drug/event, different patient.;US-PFIZER INC-2021065210 same reporter/drug/event, different patient.;US-PFIZER INC-2021065201 same reporter/drug/event, different patient.;US-PFIZER INC-2021065209 same reporter/drug/event, different patient.;US-PFIZER INC-2021065207 same reporter/drug/event, different patient.;US-PFIZER INC-2021065198 same reporter/drug/event, different patient.;US-PFIZER INC-2021065204 same reporter/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/21/2021,8.0,SEN,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1010649,CA,34.0,F,"swelling; hot to touch; started lightly at injection site but rash more prominent on sides and back of neck; started lightly at injection site but rash more prominent on sides and back of neck; scratch throat; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown due to not available/provided to reporter at the time of report completion), via an unspecified route of administration in left arm on 20Jan2021 13:30 at single dose for COVID-19 immunization. The patient's medical history included mild hashimotos (no meds, just monitor) and Polycystic ovarian syndrome (PCOS). No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. It was reported that ""48 hours"" post injection patient developed neck rash, swelling, hot to touch, started lightly at injection site but rash more prominent on sides and back of neck, and scratch throat. All the events resulted in: emergency room/department or urgent care visit. Therapeutic measures were taken as a result of all the events: Steroid and Benadryl injection. The outcome of the events was recovered with lasting effects. The events was considered as non-serious by reporter, as no resulting in death, no life threatening, no causing/prolonging hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.?; Sender's Comments: Causality cannot be excluded for PFIZER-BIONTECH COVID-19 VACCINE and the reported events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/22/2021,2.0,UNK,,,"Medical History/Concurrent Conditions: Hashimoto's disease (Mild hashimotos; no meds, just monitor); Polycystic ovarian syndrome (PCOS)",,,"['Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Rash', 'Skin warm', 'Swelling', 'Throat irritation']",UNK,PFIZER\BIONTECH, 1010651,,,M,"tested Covid19 positive; tested Covid19 positive; This is a spontaneous report from a contactable pharmacist (patient). A 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 or 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of vaccine on 05Jan2021 or 06Jan2021 and then 2 weeks later tested positive for COVID in Jan2021. The patient asked how long he was supposed to wait for the second dose. It was just a mild case and he has already recovered the few days in Jan2021. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for ""tested Covid19 positive"".",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010652,,,F,"she had the virus last year; she had the virus last year; This is a spontaneous report from a non-contactable consumer, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2020 (reported as last year), the patient ""had the virus"". It was not confirmed if the patient received the 1st dose of the vaccination prior to or after having the virus. The patient queried if she should continue to receive the 2nd dose. The clinical outcome of ""had the virus"" was unknown. No follow-up attempts are possible; Information about batch/lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Unevaluable event'],1,PFIZER\BIONTECH, 1010667,GA,57.0,F,"hard time breathing; Rash all over body; This is a spontaneous report from a contactable pharmacist. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3249), intramuscular at arm left on 24Jan2021 at 13:30 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24Jan2021 at 13:30, the patient experienced rash all over body and hard time breathing. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL and EPIPEN. The patient outcome of the events was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events dyspnea and rash cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/24/2021,0.0,SEN,,,,,,"['Dyspnoea', 'Rash']",1,PFIZER\BIONTECH,OT 1010673,NY,47.0,M,"Erectile Dysfunction; This is a spontaneous report from a contactable Other HCP. A 47-year-old male Other HCP reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular at single dose into the right arm on 05Jan2021 09:30 AM for COVID-19 immunization. Medical history included kidney stones. Concomitant drugs were unknown. The patient reported that on 20Jan2021 he experienced erectile dysfunction. No treatment was received. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset. More information such as complete medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/20/2021,15.0,PVT,,,Medical History/Concurrent Conditions: Kidney stones,,,['Erectile dysfunction'],UNK,PFIZER\BIONTECH,OT 1010674,PA,,F,"First vaccine 31Dec, tested positive for covid 01Jan; First vaccine 31Dec, tested positive for covid 01Jan; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for self that the 21-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19, Pfizer), via an unspecified route of administration on 31Dec2020 02:30 PM on Right arm at single dose for covid-19 immunisation. Medical history included known allergies: Cefdinir, asthma, anxiety, and depression. Concomitant medications included Duloxetine, lamotrigine, buspirone hydrochloride (BUSPAR), etonogestrel (NEXPLANON), ethinylestradiol/ norethisterone acetate (JUNEL). First vaccine 31Dec2020, tested positive for covid 01Jan2021, had second dose 21Jan2021. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/01/2021,1.0,UNK,DULOXETINE; LAMOTRIGINE; BUSPAR; NEXPLANON; JUNEL,,Medical History/Concurrent Conditions: Anxiety; Asthma; Depression,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010680,VA,,F,"Diagnosed with Covid 19; Diagnosed with Covid 19; This is a spontaneous report from a contactable Nurse reported for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 09Jan2021 at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. She was diagnosed with Covid 19 on 18Jan2021. She was supposed to get second dose on 26Jan2021. The outcome of the events was unknown. Information about batch number was not available and is going to be requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/18/2021,9.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010682,TX,23.0,F,"Bell's Palsy; progressed to left facial drooping; loss of taste on anterior part of tongue; decreased tear production in my left eye; started with left neck pain; This is a spontaneous report from a contactable other health care professional (HCP) (patient). A 23-year-old female patient not pregnant received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Left arm on 09Jan2021 at 04:30 PM as a single dose for COVID-19 immunisation, lot number: EL1283. Medical history was reported as none. Concomitant medications in two weeks prior to the vaccination included oral contraceptive pill (OCPs). Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 at 04:00 PM at Left arm for COVID-19 immunisation, lot number: EK5730. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 22Jan2021 03:00 PM (Symptom onset was 2 weeks after second vaccine) patient initially started to experience left neck pain, and then progressed to left facial drooping, loss of taste on anterior part of tongue, and decreased tear production in her left eye. Presentation consistent with Bell's Palsy. Patient started a course of methylprednisolone the day of the report with no improvement yet. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. Patient had not recovered from the events, at the time of the report.; Sender's Comments: The events left neck pain, and then progressed to left facial drooping, loss of taste on anterior part of tongue, and decreased tear production in her left eye are considered possibly related to the suspect product based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/22/2021,13.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Ageusia', 'Facial paralysis', 'Lacrimation decreased', 'Neck pain']",2,PFIZER\BIONTECH, 1010685,CT,88.0,F,"flushed in the face/warm; red face; tingling sensation of lips but no swelling; mild allergic reaction; This is a spontaneous report from contactable consumers. An 88-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 20Jan2021 11:45 at single dose (left arm) for COVID-19 immunization. Medical history included lung cancer. The patient was not pregnant. Concomitant medications were not reported. It was reported that the patient had unspecified other medication in two weeks. The reporter's mother's experienced mild allergic reaction in Jan2021 and she wants to know whether or not she should be getting her second dose. She will be asking her doctor as well as they were advised by the nurse administering the vaccine and also the doctor's nurses who observed her mother afterwards, but she was also advised to contact Pfizer. On 20Jan2021, at 12:00, within 5 minutes, the patient experienced flushed in the face/warm, red face, tingling sensation of lips but no swelling, no increased blood pressure, no hives or rash, no tongue or throat swelling, no dizziness, no nausea. It was mild but concerning. The patient was treated with oral Benadryl and Pepcid IV (also reported as IV of peptids), and extended observation for 1 hour and 30 minutes. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had no Covid prior vaccination and was not Covid tested post vaccination. The consumer would like to know if her mother was safe to receive the second dose of the Covid vaccine and if the reaction to the second dose of the Covid vaccine will be more severe with a history of an allergic reaction to the first dose. Outcome of event mild allergic reaction was unknown; outcome of the rest of events was recovered in Jan2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Lung cancer,,,"['Erythema', 'Flushing', 'Paraesthesia oral', 'Skin warm']",1,PFIZER\BIONTECH, 1010690,NY,28.0,F,"Passed out; fell; became disoriented and weak; became disoriented and weak; could not control her body, all muscles felt heavy and weak; could not control her body, all muscles felt heavy and weak; Felt tingles in feet and lower legs; This is a spontaneous report from a contactable consumer(patient). The 28-year-old female patient(not pregnant) received first dose BNT162B2(COVID 19, lot number: EL9262), via an unspecified route of administration at left arm on 22Jan2021 13:00 at single dose for COVID-19 immunization. Medical history included none. She had no known allergies. Concomitant medication included spironolactone, amfetamine aspartate/amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), vitamin b complex (VITAMIN B), ergocalciferol (VIT D), ZINC, omeg(omeprazole). There was no other vaccine in four weeks. About 11 hours after receiving(23Jan2021), she very quickly became disoriented and weak, could not control her body, all muscles felt heavy and weak. She fell once and then presumably passed out - she came to after falling again. She felt tingles in feet and lower legs. After sleeping about 9 hours, she felt better. There was no treatment received, no covid prior vaccination, covid tested post vaccination. Events were assessed as non-serious. Outcome of events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/23/2021,1.0,PVT,SPIRONOLACTONE; ADDERALL; VITAMIN B; VIT D; ZINC; OMEPRAZOLE,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Asthenia', 'Discomfort', 'Disorientation', 'Fall', 'Loss of consciousness', 'Muscular weakness', 'Paraesthesia']",1,PFIZER\BIONTECH, 1010691,CO,,M,"atrial fibrillation; disease recurrence; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose on 21Jan2021 for COVID-19 immunization. medical history included atrial fibrillation. Concomitant drugs were unknown. the reporting consumer received a message on 23Jan2021 stating that the patient started having atrial fibrillation the night before. The outcome of the event was unknown. Information on batch/lot number was requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/22/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Atrial fibrillation,,,"['Atrial fibrillation', 'Condition aggravated']",1,PFIZER\BIONTECH, 1010693,VA,,U,"testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 2nd of 14 reports. An elderly patient (more than 65 years) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021 with outcome of unknown. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab. The event resulted in doctor or other healthcare professional office/clinic visit. Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/21/2021,8.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1010694,VA,,U,"testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 3rd of 14 reports. An elderly patient (more than 65 years) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021 with outcome of unknown. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab. The event resulted in doctor or other healthcare professional office/clinic visit. Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/21/2021,8.0,SEN,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1010695,VA,,U,"testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is the 4th of 14 reports. An elderly patient (more than 65 years old) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded. ,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/21/2021,8.0,SEN,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1010696,VA,,U,"Testing positive for COVID after receiving vaccine; Testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 14 patients. This report is for 5th of 14 patients. An elderly patient (more than 65 years old) of an unspecified gender received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced testing positive for COVID on 21Jan2021 after receiving vaccine. Since they were testing positive, physician wanted to administer Bamlanirimab (drug being administered under FDA EUA). The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported testing positive for COVID based on the known safety profile. However the short duration of 8 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.,Linked Report(s) : US-PFIZER INC-2021063794 Same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/21/2021,8.0,SEN,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1010697,VA,,U,"testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 6th of 14th reports. An elderly patient (more than 65 years old) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab (Lily drug being administered under FDA EUA). The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/21/2021,8.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1010698,VA,,U,"testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 7th of 14 reports. An elderly patient (more than 65 years old) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab (drug being administered under FDA EUA). The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the available information, there was a reasonable possibility that the reported events were related to the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/21/2021,8.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1010699,VA,,U,"testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 8th of 14 reports. An elderly patient (more than 65 years old) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021 with outcome of unknown. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/21/2021,8.0,SEN,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1010700,VA,,U,"testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 14 patients. This is the 9th of 14 reports. An elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It is reported patient testing positive for COVID after receiving vaccine. 8 Patients and 6 workers at a long-term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they are testing positive, physician wants to administer bamlanivimab (drug being administered under FDA EUA). Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021063794 Same reporter/product/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/21/2021,8.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1010701,VA,,U,"testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist reported similar events for 14 patients. This is 10th of 14th reports. An elderly patient (more than 65 years old) of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021 with outcome of unknown. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported testing positive for COVID based on the known safety profile. However the short duration of 8 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.,Linked Report(s) : US-PFIZER INC-2021063794 as reporter/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/21/2021,8.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1010702,VA,,U,"testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 11th of 14 report. An elderly patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown a not available/provided to reporter at the time of report completion), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunisation. The patient's medical history was not reported. For concomitant medications, it was unknown if other vaccine in four weeks or other medications in two weeks. The patient was testing positive for COVID after receiving vaccine. A total of 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab (drug being administered under FDA EUA). The events start date was 21Jan2021, and resulting in doctor or other healthcare professional office/clinic visit. It was reported as unknown if treatment was taken for the events. The outcome of the events was unknown. It was unknown if patient had COVID prior to this vaccination. The patient had been tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported ""testing positive for COVID after receiving vaccine"".,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/21/2021,8.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1010703,VA,,U,"testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar event for 14 patients. This is 12th of fourteen reports. An elderly patient (more than 65 years old) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021 with outcome of unknown. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab (drug being administered under FDA EUA). The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.,Linked Report(s) : US-PFIZER INC-2021063794 as reporter/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/21/2021,8.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1010704,VA,,U,"testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 13th of 14 report. An elderly patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown a not available/provided to reporter at the time of report completion), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunisation. The patient's medical history was not reported. For concomitant medications, it was unknown if other vaccine in four weeks or other medications in two weeks. The patient was testing positive for COVID after receiving vaccine. A total of 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab (drug being administered under FDA EUA). The events start date was 21Jan2021, and resulting in doctor or other healthcare professional office/clinic visit. It was reported as unknown if treatment was taken for the events. The outcome of the events was unknown. It was unknown if patient had COVID prior to this vaccination. The patient had been tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported ""testing positive for COVID after receiving vaccine"".,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/21/2021,8.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1010705,VA,,U,"testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is the 14th of 14 reports. An elderly patient (more than 65 years old) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab (Lily drug being administered under FDA EUA). The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported ""testing positive for COVID after receiving vaccine"".,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/21/2021,8.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1010706,IN,76.0,M,"Bell's palsy; This is a spontaneous report from a contactable physician reported for self. This 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 10:50 on Arm left at single dose (Lot # EK5730) for covid-19 immunisation. None additional vaccines administered on same date of the Pfizer suspect. Medical history included ongoing Cardiac disorder from Jun1990, Type 1 diabetes mellitus from 2000, Heart Attack from Jun1990. Concomitant drugs were none. He said he has a question. He stated he got his first dose of the COVID-19 Vaccine on 04Jan2021 and woke up 9 days later on 13Jan2021 with Bell's Palsy, which was medically significant. He said he was not sure if he should get his second COVID-19 Vaccine shot that was scheduled for Monday, 25Jan2021. He asked if Bell's Palsy has been a reported side effect of the COVID-19 Vaccine. He said he refuses to take steroids for the Bell's Palsy. He said he had an incident in 2019 where he was prescribed steroids for an arthritic condition, and he ended up septic. No treatments were received. Outcome of the event was resolving. Drug result by physician was related.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported Bell's Palsy cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/13/2021,9.0,PVT,,"Heart disease, unspecified",Medical History/Concurrent Conditions: Heart attack; IDDM,,,['Facial paralysis'],1,PFIZER\BIONTECH, 1010710,TX,,F,"it seemed she was so close to anaphylactic reaction; slight itching; swollen eyes; itchy throat; super red ears; generalized hives; rash; progressive hypersensitivity reaction; anxious; This is a spontaneous report from a non-contactable nurse(patient). An adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Jan2021 at single dose for COVID-19 immunization. Medical history included skin asthma with severe eczema and severe allergy when she moved. Day 1 to 7 post-vaccine, there was no reaction, the patient was super fine. The patient remembered that on Day 4, she had slight itching relieved by loratadine (CLARITIN), just like her usual allergy symptoms. From Day 8 to Day 12, she had progressive hypersensitivity reaction that led to her swollen eyes, itchy throat, super red ears and generalized hives. It started as a rash similar to her usual allergy. She ended up going to urgent care by herself since her husband was at work, because it seemed she was so close to anaphylactic reaction (?). At first, loratadine was working but at the time of report, it did not work for the events. She was not admitted because there was no shortness of breath. The patient was on close monitoring for progression of symptoms starting on 22Jan2021. She was anxious and was having second thoughts of getting the second dose of the vaccine. According to her, she had skin asthma with severe eczema, so maybe, the vaccine was not to be recommended to persons with severe allergies like her. She had severe allergies when she moved and was planning to see an allergologist soon. The outcome of slight itching was recovering, of the events were not reported. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Based on the time association and drug's safety profile, the event anaphylactic reaction is possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Allergy (skin asthma with severe eczema and severe allergy when she moved.); Asthma (skin asthma with severe eczema and severe allergy when she moved.); Eczema (skin asthma with severe eczema and severe allergy when she moved.); Skin disorder (skin asthma with severe eczema and severe allergy when she moved.),,,"['Anxiety', 'Erythema', 'Eye swelling', 'Hypersensitivity', 'Pruritus', 'Rash', 'Throat irritation', 'Urticaria']",1,PFIZER\BIONTECH, 1010715,TN,49.0,F,"Bells Palsy; This is a spontaneous report from a contactable Other HCP(patient). A 49-years-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), intramuscular on 05Jan2021 19:00 at the 49 years old at Arm Right at single dose for COVID-19 immunization. The medical history was not reported. The concomitant medications were none. There was no other vaccine in four weeks. There were no other medications in two weeks. The patient experienced Bells Palsy on 20Jan2021 15:00. The event caused Physician Office Visit. The patient received Steroids and viral antibiotic as treatment for the event. There was no COVID prior vaccination. There was no COVID tested post vaccination. There were none known allergies. The outcome of the event was not recovered. The information on the batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for event Bell's palsy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/20/2021,15.0,PVT,,,,,,['Facial paralysis'],1,PFIZER\BIONTECH,OT 1010716,NC,85.0,F,"Sudden slurring of speech slight mouth droopiness; Sudden slurring of speech slight mouth droopiness; Sudden loss of consciousness; difficulty in bringing her hand to mouth to eat-opposite arm from injection site / Difficulty walking, getting out of bed; Increasing confusion, soreness, pain, throughout as well as injection site; Increasing confusion, soreness, pain, throughout as well as injection site; Increasing confusion, soreness, pain, throughout as well as injection site; Difficulty walking, getting out of bed.; Severe lethargy, tiredness, sleepiness; Severe lethargy, tiredness, sleepiness; Severe lethargy, tiredness, sleepiness; This is a spontaneous report from a contactable other HCP. An 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EK9231) intramuscular in left arm on 19Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included beginning signs of dementia, stage II breast cancer not immune compromised, no chemo no radiation only hormone therapy, and hormone therapy. There was no known allergies. The patient was not pregnant. There were other unspecified medications in two weeks. After 3-4 hours after injection on 19Jan2021 19:30 she had difficulty in bringing her hand to mouth to eat-opposite arm from injection site. Increasing confusion, soreness, pain, throughout as well as injection site. Difficulty walking, getting out of bed. Severe lethargy, tiredness, sleepiness. Day 3 after vaccine on 22Jan2021, all other symptoms still present and worsening, then sudden slurring of speech slight mouth droopiness, then sudden loss of consciousness. Could not be woke up for about 15 minutes then opened eyes but not aware of surroundings. Taken to hospital for work up. On day 4 after vaccine still confused not at normal baseline. Needs assistance in walking, eating, etc. Events resulted in: Emergency room/department or urgent care, Hospitalization for 7 days, Disability or permanent damage. The patient received treatment such as ER and ongoing hospital stay with Pt and OT for events. She received COVID test via nasal swab on 22Jan2021 with result of negative. Events outcome of difficulty in bringing her hand to mouth to eat-opposite arm from injection site, increasing confusion, soreness, pain, throughout as well as injection site, difficulty walking/getting out of bed, severe lethargy, tiredness, sleepiness was not recovered, while for others was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,7.0,Yes,N,01/19/2021,01/19/2021,0.0,UNK,,,"Medical History/Concurrent Conditions: Breast cancer stage II (stage II breast cancer not immune compromised, no chemo no radiation only hormone therapy.); Dementia; Hormone therapy",,,"['Confusional state', 'Coordination abnormal', 'Disorientation', 'Dysarthria', 'Facial paralysis', 'Fatigue', 'Gait disturbance', 'Hand-eye coordination impaired', 'Injection site pain', 'Lethargy', 'Loss of consciousness', 'Mobility decreased', 'Pain', 'SARS-CoV-2 test negative', 'Somnolence']",1,PFIZER\BIONTECH,OT 1010718,FL,,F,"Arm at the site a little bit above the elbow where biceps are, were sore,; slight headache; exhausted; bad cold/cold type symptoms; upper respiratory infection with a sinus infection; upper respiratory infection with a sinus infection; mild respiratory infection; not feeling well; like a viral cold; nausea; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location: arm) on 09Jan2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history included psoriatic arthritis from an unknown date and unknown if ongoing. Concomitant medication included paracetamol (TYLENOL). It was reported that patient wanted to know if she should get the second vaccine in the series. Patient mentioned that she had the first Pfizer Covid vaccine 09Jan2021. Approximately three weeks later, she developed a mild respiratory infection. It was mentioned that patient has psoriatic arthritis (one Dr told her she would experience more symptoms getting the second dose- another Dr told her she could die) and her physician wants her to start methotrexate, however, she is not currently taking this product. Patient is currently only taking paracetamol. Patient also mentioned that she had three friends who had the Pfizer Covid vaccine and they felt awful like they had the flu for 48 hours post vaccination. Patient asked if there was no allergic reaction to the first vaccine, will there be no allergic reaction to the second vaccine. Patient also asked if it is okay to start on methotrexate after having the vaccine and if this will decrease effectiveness. On an unknown date in Jan2021, patient stated she is not feeling well last night, something like a viral cold. Patient also stated ""It was not bad at all. Arm at the site a little bit above the elbow where biceps are, were sore, slight headache the day after the 1st dose, after 3-4 hours I was exhausted, 2 days exhausted, maybe slightly nausea"". Patient also mentioned Thursday night that she had a very bad cold from the beginning and has upper respiratory infection with a sinus infection. It was also reported that patient was not on immunosuppressants and has never had anaphylaxis. It was also reported that patient had swelling in her hand from the arthritis. On 21Jan2021, it was reported that patient went to urgent care with upper respiratory symptoms and a COVID test was performed which was negative. Patient stated that she is to have #2 covax this coming Saturday and is still dealing with some cold type symptoms and asks if she should get the second covax. Patient is not running a fever. Outcome of the event 'bad cold/cold type symptoms' was not recovered, outcome of the remaining events was unknown. Information on lot number/batch number has been requested; Sender's Comments: Based on the temporal relationship, the association between the event upper respiratory tract infection with BNT162b2 can not be completely excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/01/2021,,UNK,TYLENOL,,Medical History/Concurrent Conditions: Psoriatic arthritis,,,"['Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Nausea', 'Pain in extremity', 'Peripheral swelling', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 1010720,NJ,56.0,F,"Tachycardia; shortness of breath; rigors; muscle pain; fatigue; headache; This is a spontaneous report from a Contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=Fl3249), via an unspecified route of administration in left arm on 19Jan2021 13:00 at first single dose for COVID-19 immunization. Medical history included high cholesterol, gastrooesophageal reflux disease (GERD), dry eye syndrome, covid-19 (covid prior vaccination). Known allergies: No. Concomitant medication included atorvastatin, fish oil, pantoprazole. No other vaccine received in four weeks. The patient experienced tachycardia, shortness of breath, rigors, muscle pain, fatigue, headache, on 20Jan2021 02:30 AM. Events resulted in: Emergency room/department or urgent care. Events treatment inluded: Fluids, tylenol, clonazepam. Covid was not tested post vaccination. Outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/20/2021,1.0,PVT,ATORVASTATIN; FISH OIL; PANTOPRAZOLE,,Medical History/Concurrent Conditions: COVID-19 (if covid prior vaccination: Yes); Dry eye syndrome; GERD; High cholesterol,,,"['Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Myalgia', 'Tachycardia']",1,PFIZER\BIONTECH, 1010722,,,M,"ended up in the ER with heaviness around his chest; ""fluttering chest""; ended up in the ER with heaviness around his chest; ""fluttering chest""; This is a spontaneous report from a contactable Other-HCP. A 72-year-old male patient (Dad) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunisation. One day after the 1st COVID19 vaccine dose, the patient ended up in the ER with heaviness around his chest; ""fluttering chest"". Felt fine 2 days later. Outcome of the events were recovered. Information on the lot/batch number has been requested.; Sender's Comments: A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of heaviness chest and futtering chest cannot be excluded due to temporal relationship. However, it is worth nothing that the patient was 72-year-old, and medical history and concomitant drugs not provided. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Cardiac flutter', 'Chest discomfort']",1,PFIZER\BIONTECH, 1010724,NC,42.0,F,"blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; This is a spontaneous report from a contactable consumer(patient). The 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 22Jan2021 13:10 at single dose for COVID-19 immunization. Medical history included ongoing injury to right foot. Concomitant drug included Steroid from 21Jan2021 and ongoing for injury to right foot. There was no prior Vaccinations within 4 weeks. On 22Jan2021, the patient experienced blood pressure skyrocketed and body was really hot touch with outcome of recovering, dizziness and shortness of breath with outcome of recovered on 22Jan2021, headache with outcome of not recovered. Patient went to Emergency Room for all events on 22Jan2021. It was reported that Patient received the first dose of the Covid-19 vaccine today. Patient had a severe reaction and went to the Emergency Room. Her blood pressure shyrocketed. She experienced dizziness, her body was really hot. You could feel it to touch. She had a headache and shortness of breath. Then She was given Benadryl, Zofran and steroids at the Emergency Room, no physician office. She was released because she was going home and going to bed. Information about Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,PVT,,Foot injury,,,,"['Blood pressure increased', 'Dizziness', 'Dyspnoea', 'Feeling hot', 'Headache', 'Skin warm']",1,PFIZER\BIONTECH, 1010725,NJ,,F,"tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. She received her first COVID-19 vaccine at Pharmacy on 28Dec2020. She was supposed to get her second vaccine after 21 days on 18Jan2021. She ended up testing positive for Covid-19 on 13Jan2021, so she missed that second appointment on 18Jan2021 because she had to quarantine since she tested positive. They are coming back again on Monday, 25Jan2021, which would be 28 days. She mentioned she has already recovered from the virus, and wants to know if she could now receive the 2nd dose of the vaccine even if it is already 28 days after her 1st dose. She wants to know can she get the second vaccine on Monday or does she need to wait 3 months re-do the whole thing? Events outcome was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/13/2021,16.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010728,,,F,"HCP had both doses of Covid vaccine and then tested positive for Covid.; HCP had both doses of Covid vaccine and then tested positive for Covid.; This is a spontaneous report from a Pfizer-sponsored program received from a contactable Other Health Professional (HCP) reported for herself. A female patient of unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both via unspecified route of administration on unspecified dates at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient had both doses of Covid vaccine and then tested positive for Covid on an unspecified date. She was wondering if there were any clinical trials going on that were studying people that tested positive after being vaccinated. The outcome of the events was unknown. Information on the batch number/lot number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 1010730,FL,79.0,U,"Became very unsteady walking; Became very unsteady walking; Have fallen several times; took 1 extra pill of amantadine after the first dose by mistake; balance became bad; This is a spontaneous report from a contactable consumer reported for self. This 79-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1284) via an unspecified route of administration on 08Jan2021 at 14:30 PM as a single dose in right arm for COVID-19 immunisation. Co-suspect medication included amantadine from an unspecified date at unspecified dosage for Parkinson's Disease. Medical history included Parkinson's, penicillin allergy and ongoing unsteady. Concomitant medications included medications for Parkinson's disease. The patient had no vaccine in four weeks. The patient became very unsteady walking, had fallen several times 09Jan2021 at 07:30 AM. Patient was already unsteady before the vaccine, but not falling down which started soon after receiving the first dose of vaccine. The patient was scheduled for the second dose on 30Jan2021. Patient also took 1 extra pill of amantadine after the first dose of vaccine by mistake and balance became bad and remained so since. The patient suspected that maybe combo of the vaccine and Parkinson's Disease medication is an issue. The patient purchased walker and was recommended to physical as treatment. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient had no COVID prior and post vaccination. The action taken of amantadine was unknown. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/08/2021,01/01/2021,,PVT,,Unsteady gait (Already unsteady before the vaccine),Medical History/Concurrent Conditions: Parkinson's disease; Penicillin allergy,,,"['Balance disorder', 'Condition aggravated', 'Fall', 'Gait disturbance', 'Walking aid user']",UNK,UNKNOWN MANUFACTURER, 1010734,FL,,M,"Positive for the virus; Positive for the virus; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient). A 70-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient received his 1st dose of Covid 19 Vaccine 11Jan2021 and after a couple of days showed positive for the virus, but in other results, it shows negative, but he doesn't want to take the risk that's why he's concerned now for his safety. He's aware that his 2nd dose of Covid 19 Vaccine will be on 01Feb2021. He's feeling good now but just wants to let us know. On 21Jan2021, he tested positive. The outcome was unknown. Information about Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/21/2021,10.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010737,MI,,M,"chest pain; This is a spontaneous report from a contactable consumer (niece) who reported for her grandfather A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration at single dose on 23Jan2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chest pain on an unspecified date. The patient was hospitalized for chest pain from 24Jan2021. The outcome was unknown Information on Lot/Batch has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/23/2021,,,UNK,,,,,,['Chest pain'],1,PFIZER\BIONTECH, 1010739,FL,,U,Bell's palsy; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A patient of unknown gender and age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient got Bell's palsy after the 1st dose on unknown date. The outcome of the vent was unknown. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Facial paralysis'],1,PFIZER\BIONTECH, 1010742,PA,,F,"Tested positive for COVID-19 after being exposed to others who were positive for COVID-19; Tested positive for COVID-19 after being exposed to others who were positive for COVID-19; She had some sniffles; This is a spontaneous report from a contactable Consumer (Patient). A female patient of unspecified age (reported as 45, Units: Unknown) received the first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient received first shot of the Pfizer COVID-19 vaccine, but then tested positive for COVID-19 after being exposed to others who were positive for COVID-19. She had some sniffles but experienced no other symptoms. Events took place after use of product. The outcome of the events was unknown. The information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Exposure to SARS-CoV-2', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010744,,,U,"Patient got covid vaccine yesterday. Got positive the day after.; Patient got covid vaccine yesterday. Got positive the day after.; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got covid vaccine yesterday (on 21Jan2021), got positive the day after (on 22Jan2021). Caller said the patient may have Covid before getting the vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/22/2021,1.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1010746,CO,79.0,F,"hypertension/Blood pressure high; Really tired; some stuff with her kidneys; This is a spontaneous report a Pfizer Sponsored Program from a contactable consumer (patient). A 79-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EL8982) on 16Jan2021 14:30 at single dose in right arm for to prevent Covid-19. Medical history included ongoing sjogren's syndrome, hypertension. Prior vaccinations, the patient maybe tired and unwell from the flu vaccine and shingles vaccine (SHINGRIX) for immunization. There were no concomitant medications. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient got her first vaccine on 16Jan2021. About 3 days later, on 19Jan2021, she was really tired but it only lasted for that one day. States that on 19Jan2021, 20Jan2021, and 21Jan2021, her blood pressure shot way up and she went to the ER on 21Jan2021 because it had been so high for a few days. States that at home it was 172/104, 172/107, and 200/103. When she got to the ER it was 200/110. States that her blood pressure has improved on it's own today. While she was in the ER, they checked her Troponin's which were low, her EKG was normal, and the doctor said everything looked okay, except some stuff with her kidneys but that doesn't have anything to do with her blood pressure. Before she got the first dose she had a history of hypertension but it was already managed by medication and her BP was on normal range prior to vaccination. The AEs High blood pressure and Really tired require a visit to Emergency room on 21Jan2021. The patient was on BP medications. The patient was hospitalized for hypertension and Really tired. The outcome of hypertension was recovering, of Really tired was recovered on 19Jan2021, of other events were unknown. Second dose was scheduled on 06Feb2021.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/16/2021,01/01/2021,,OTH,,Sjogren's disease,Medical History/Concurrent Conditions: Hypertension,,,"['Blood pressure increased', 'Electrocardiogram normal', 'Fatigue', 'Hypertension', 'Renal disorder', 'Troponin normal']",1,PFIZER\BIONTECH, 1010747,NC,,M,"cough; This is a spontaneous report from a Pfizer sponsored program by a contactable consumer. A male patient (Husband) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at single dose for covid-19 immunisation. He went to his family physician for a cough and was prescribed amoxicillin for a few days. 21Jan2021 he received the first dose Covid vaccine, wondering if he can start a prescription of amoxicillin right now. It was not confirmed if he had cough before getting Covid vaccine or not. Outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,,,UNK,,,,,,['Cough'],1,PFIZER\BIONTECH, 1010749,,,F,tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for self. A female patient with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On the 4th patient received 1st dose then about a week later tested positive for COVID (Jan2021) and wanted to know if it is safe to receive 2nd dose. The outcome of event was unknown. Information about Batch/Lot number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010750,PA,,M,"got their 1st Covid vaccine and now has Covid; got their 1st Covid vaccine and now has Covid; This is a spontaneous report from a Pfizer sponsored program Pfizer. A contactable pharmacist reported a male patient (another pharmacist) of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on unknown date. Medical history and concomitant medication were not reported. The patient got the first dose of COVID vaccine and now had COVID. Action taken for BNT162B2 was not applicable and outcome of the event was unknown. Information on lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010757,,,F,"positive for Covid; positive for Covid; This is a spontaneous report from a Pfizer-sponsored program . A contactable other health care professional reported for self. A female of an unknown age received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 06Jan2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. The patient received 1st dose of Covid vaccine on 06Jan2021 and then tested positive for Covid on an unknown date in Jan2021. She was wondering what she should do about the 2nd dose. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010758,,,F,"Patient tested positive after 1st dose; Patient tested positive for Covid after 1st dose; This is a spontaneous report from a Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, batch/lot number and expiration date not provided), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter has patient who had 1st dose of COVID vaccine on 13Jan and then tested positive for COVID. She is calling today because her patient is scheduled for her next dose on 15Feb and she wants to make sure that date is ok. The patient underwent lab tests and procedures which included tested positive for COVID on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of bnt162b2(COMIRNATY), on 13Jan2021, and COVID-19 test positive on an unspecified date. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection. Further information like COVID infection date needed for a full meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010765,FL,,M,"asthma and COPD and having more episodes; asthma and COPD and having more episodes; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable male consumer (patient) with unspecified age reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. Medical history included asthma and COPD both ongoing (he clarified he was having episode before doing the vaccination, he had had the breathing issues for a very long time). The patient's concomitant medications were not reported. Patient had asthma and COPD and having more episodes in Jan2021 with outcome of unknown, and was given methylprednisolone (MEDROL) dose pack, he was asking if he took this would it affect the efficacy of vaccine. It was reported patient would be due for second dose of BNT162B2 on 01Feb2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/01/2021,,UNK,,Asthma (had the breathing issues for a very long time); COPD (had the breathing issues for a very long time),,,,"['Asthma', 'Chronic obstructive pulmonary disease', 'Condition aggravated']",1,PFIZER\BIONTECH, 1010766,,,U,Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A patient of unknown gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had an allergic reaction to the COVID vaccine and she/ he was sent to the ER for treatment. The outcome of the event was unknown. Information on Lot/Batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Hypersensitivity'],UNK,PFIZER\BIONTECH, 1010772,NC,,F,"pain in her hand unable to use it for a few days; This is a spontaneous report from a non-contactable nurse reporting for herself An adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 04Jan2021 for covid-19 immunisation. Medical history was none. Concomitant medication included ibuprofen. The patient experienced pain in her hand unable to use it for a few days on Jan2021. Therapeutic measures included tylenol. SARS-Cov-2 test nasal swab in Jan2021 was negative. The outcome was recovered Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of event Pain in hand cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,Y,01/04/2021,01/01/2021,,PVT,IBUPROFEN,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Pain in extremity', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 1010774,LA,72.0,M,"Covid Positive; Covid Positive; This is a spontaneous report from a contactable consumer (wife). A 72-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1283 and Expiration Date unknown) via Intramuscular on 12Jan2021 16:30 (vaccine location: right arm ) at single dose for COVID-19 immunisation. The patient's medical history included Kidney stones and heart issues (sees a cardiologist). The concomitant medications was reported as unspecified drugs. No previous vaccine in four weeks. Patient went to urgent care this morning and had a rapid test that came back positive and had covid. Lab test included positive rapid covid test on 21Jan2021. The outcome of event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/21/2021,9.0,PVT,,,Medical History/Concurrent Conditions: Heart disorder (He sees a cardiologist); Kidney stones,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,OT 1010793,NC,72.0,M,"husband is breaking out in cold chills, and his bones are still sore.; inflamed liver; arm is still sore; Nauseated; has no energy; sick; no appetite; he is sweating; he is tired.; husband is breaking out in cold chills, and his bones are still sore.; This is a spontaneous report from a contactable consumer. This consumer reported for a 72-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration on 19Jan2021 08:00 at single dose on left arm for COVID-19 prevention. The medical history and concomitant medications were not reported. The patient got the shot on 19Jan2021. Since Jan2021, his arm was still sore, but he had been nauseated since then. He has no energy. He has had it almost four days. He was fine until he got it and his arm is sore and he is nauseated. He is usually on the go. The patient also has an inflamed liver. He has been sick since. The patient has no appetite, he is sweating, his bones are hurting, and he is tired. The consumer took her husband to his doctor, and they tested him for COVID, and it came back negative, but the consumer does not think the PA did the test right. The consumer doesn't know what to do with him, because he is still tired, and has no appetite. The patient is breaking out in cold chills, and his bones are still sore. When the patient got the vaccine, he was walking and talking, and by 11 AM that day, he was in bed. The patient had some labs done, and was being told that his liver is big, so the consumer did not know if the vaccine went to his liver. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/01/2021,,UNK,,,,,,"['Asthenia', 'Bone pain', 'Chills', 'Decreased appetite', 'Fatigue', 'Hepatitis', 'Hyperhidrosis', 'Laboratory test', 'Nausea', 'Pain in extremity', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH, 1010794,NJ,67.0,F,"blood pressure went up considerably; Heart racing; suddenly felt very warm; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 21Jan2021 at 14:45 (at the age of 67-years-old) as a single dose for Covid-19 immunization. Medical history included a history of asthma. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination or additional vaccines on the same day. On 21Jan2021 around a half hour after administration (also reported as within 40 minutes) the patient started having symptoms of suddenly felt very warm, her blood pressure went up considerably and her heart was racing. The patient went to Urgent Care and Urgent Care advised to take her to the Emergency Room as they did not have an EpiPen. The patient was advised to go to the Emergency Room and was in transit to the ER. The clinical outcome of the events blood pressure increased and palpitations was not recovered; for feeling hot it was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Asthma,,,"['Blood pressure increased', 'Feeling hot', 'Palpitations']",1,PFIZER\BIONTECH,OT 1010796,MN,,U,"Got the first dose of the COVID Vaccine, and then tested positive for the virus; Got the first dose of the COVID Vaccine, and then tested positive for the virus/developed covid after the first dose; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable pharmacist reported that a patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Pharmacist on the line calling about a patient who got the first dose of the COVID Vaccine, and then tested positive for the virus, also reported as the patient received the first dose of vaccine and then developed covid after the first dose. She was asking if it was okay for the patient to get the second dose. The outcome of the event was unknown. Information on the Lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010799,CA,44.0,F,"tested positive for COVID/stuffy nose/couldn't smell; tested positive for COVID/stuffy nose/couldn't smell; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a 44-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, Lot Number: ER5730 or EK5730), via an unspecified route of administration at Arm right on 18Dec2020 17:00 at the 44 years old at single dose for COVID-19 immunization. The medical history was none. The Family Medical History Relevant to adverse events was none. The concomitant medication was none. The patient was supposed to work the day she tested positive but had a stuffy nose on 01Jan2021. She wasn't sure if that was what it was but when she took a shower she couldn't smell the body wash and so she knew she had COVID. She had a rapid test used for the positive test for COVID on 01Jan2021. There was no hospitalization due to testing positive. The events did not require a visit to Emergency Room and Physician Office, but she did go to the urgent care to get the rapid test.There was no Prior Vaccinations (within 4 weeks). There was none additional Vaccines Administered on Same Date of the product. The patient underwent lab tests and procedures, which included tested positive for COVID on 01Jan2021. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,01/01/2021,14.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Anosmia', 'COVID-19', 'Nasal congestion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010815,MI,35.0,F,"tachycardia HR into 140s; numbness and tingling around lips; numbness and tingling around lips; warm flushing; This is a spontaneous report from a contactable nurse (patient). This 35-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249) intramuscular, in left arm, on 22Jan2021 at 08:00, for COVID-19 immunization. No other vaccine was given on the same day or in 4 weeks. The patient received the first dose of BNT162B2 vaccine on 04Jan2021 at 03:00 PM, lot number EK9231, intramuscular, in left arm. Medical history included Crohn's disease. The patient had no COVID before vaccination. Concomitant medication included azathioprine (IMURAN) at 150 mg, daily. On 22Jan2021 the patient experienced warm flushing within 5 minutes of vaccination and at 08:15 tachycardia (HR into 140s), numbness and tingling around lips. The events required Emergency room/department or urgent care and treatment with diphenhydramine (BENADRYL) 25 mg IV. COVID was not tested after vaccination. The events were resolving.; Sender's Comments: Based on a compatible temporal association, causality between events tachycardia (HR into 140s), numbness and tingling around lips and warm flushing and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,PVT,IMURAN [AZATHIOPRINE],,Medical History/Concurrent Conditions: Crohn's disease,,,"['Flushing', 'Hypoaesthesia oral', 'Paraesthesia oral', 'Tachycardia']",2,PFIZER\BIONTECH,OT 1010818,,,F,"covid tested post vaccination, tested positive in PCR test, 7 days after receiving second dose; covid tested post vaccination, tested positive in PCR test, 7 days after receiving second dose; This is a spontaneous report from a non-contactable consumer. A 31-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose, second dose via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient didn't get covid prior vaccination. Covid was tested post vaccination and tested positive in PCR test in Jan2021, 7 days after receiving second dose. There was no treatment received. The patient underwent lab tests and procedures which included PCR test: positive in Jan2021. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/01/2021,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 1010821,OH,,F,"She had a positive covid test on 16Jan2021. Symptoms on 10Jan2021; She had a positive covid test on 16Jan2021. Symptoms on 10Jan2021; headache; Fatigue; This is a spontaneous report from a contactable Other HCP. A 48-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL0142 and Expiration Date unknown) via Intramuscular on 08Jan2021 12:00 PM (vaccine location: Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EK5730 and Expiration Date unknown) via Intramuscular on 19Dec2020 11:15 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation and first dose of measles vaccine, mumps vaccine, rubella vaccine (MMR) booster for immunisation. The patient's medical history was included allergies to nubain and CT dye, chronic sinus issues. The concomitant vaccine included second dose of measles vaccine, mumps vaccine, rubella vaccine (MMR) booster on 23Nov2020 for immunisation. Patient had symptoms of increase headache and fatigue on 10Jan2021. Patient had a positive covid test on 16Jan2021. The outcome of events was not recovered and without treatment received.; Sender's Comments: Based on the available information, causality between events Drug ineffective / COVID-19 virus test positive and BNT162B2 vaccine cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/10/2021,2.0,PVT,,,Medical History/Concurrent Conditions: Chronic sinusitis; Contrast media allergy,,,"['COVID-19', 'Fatigue', 'Headache', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,OT 1010823,MI,33.0,F,"allergic reaction to the product/ throat was swelling and started to close up/ hives and itching/ blood pressure dropped and heart rate increased/ chest tightness; This is a spontaneous report from a contactable consumer (patient). A 33-year-old-female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL3248), via an unspecified route of administration into left deltoid on 21Jan2021 10:20 at a single dose for covid-19 immunization. The patient was allergies to sulfa medications and latex and she had the flu vaccine in Nov2020. The patient concomitant medications were none. The patient called to report on the COVID 19 vaccine and she had an allergic reaction to the product. The patient explained that she got the vaccine yesterday at around 10:20 am and was in the emergency room at 10:48 am. Her throat was swelling and started to close up and this has resolved after medication. She had hives and itching which are now ongoing and about the same, her blood pressure dropped and there was an increased in her heart rate which have both gotten better, and she had chest tightness which is about the same. She received IV Benadryl, Solumedrol, and Pepcid. The patient was treated and released from the emergency room. No investigation assessment. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Latex allergy; Sulfonamide allergy,,,"['Blood pressure decreased', 'Chest discomfort', 'Heart rate increased', 'Pharyngeal swelling', 'Pruritus', 'Throat tightness', 'Urticaria']",UNK,PFIZER\BIONTECH, 1010831,FL,43.0,F,"patient received both doses of COVID-19 vaccines and tested positive for COVID-19; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EH9899/expiration date: unknown), via unknown route of administration, on 22Dec2020 13:00 PM (at the age of 43 years old) as a single dose on right arm and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1284/expiration date: unknown), via unknown route of administration, on 11Jan2021 09:30 AM (at the age of 43 years old) as a single dose on left arm, for COVID-19 immunisation at a hospital. Relevant medical history included exposure to COVID-19 on 15Jan2021 because her oldest son tested COVID positive on Tuesday with a rapid COVID test and she had dinner with her son on Friday (15Jan2021). Historical vaccine included flu shot in Oct2020. Relevant concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received both doses of COVID-19 vaccines and tested positive for COVID-19 via COVID PCR test on 20Jan2021. The patient reported that she was asymptomatic and was at home quarantining. The patient would like inquire for information on volunteering in any post-vaccination research trials as she would be a candidate for it. Laboratory test included COVID PCR (polymerase chain reaction) test on 20Jan2021 with positive result. The outcome of the events ""patient received both doses of COVID-19 vaccines and tested positive for COVID-19 via COVID PCR test"" was unknown. It was also reported that the sample of product was not available to be returned.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/20/2021,9.0,PVT,,,Medical History/Concurrent Conditions: Exposure to COVID-19,,,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 1010834,FL,73.0,F,"cellulitis from the shot in left arm; This is a spontaneous report from a contactable consumer reported for herself. This 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 in her left arm at single dose for covid-19 immunisation. Medical history and concomitant medications were none. There were no additional vaccines administered on same date of BNT162B2. The patient previously received a pneumococcal vaccine (reported as pneumonia shot) on unspecified date for immunisation where kind of the same thing happened, she had red, bumped up and itchiness at the injection. she didn't remember if she was diagnosed with cellulitis as it was a long time ago and she has no NDC, Lot, or Expiry for the product. The patient experienced cellulitis from the shot in left arm on 22Jan2021. The event did not require a visit to Emergency Room. She just called the doctor and was given a prescription, the name of the prescription was unknown. The outcome of event was not recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/22/2021,9.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Injection site cellulitis'],1,PFIZER\BIONTECH, 1010841,PA,55.0,F,"1st dose- 06Jan2021/ her 2nd dose received on 20Jan2021; wiped out/ tired; headache; had no energy; Rigors; fever of 102.6; This is a spontaneous report from a contactable nurse (patient). This 55-year-old female patient received her 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 20Jan2021 at 8:45AM via an unknown route at right arm for Covid-19 immunization. No vaccines administered on same date with the Pfizer vaccine considered as suspect. Medica history and concomitant drug were reported as ""none"". Patient previously had 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 in right arm (Lot/NDC/Expiry unknown). No other vaccinations within four weeks prior to the first administration date of the suspect vaccine; no adverse events following prior vaccinations. No family medical history relevant to adverse event. The patient reported some side effects from her 2nd dose received on 20Jan2021 at 8:45AM. She had a fever of 102.6 which started at 8pm on 20Jan2021 and broke this morning at 6am. The patient stated that the fever was gone, but she wouldn't say she has recovered completely because she still feels wiped out; had headache and was tired; also stated that she was not able to eat, and had no energy while she had the fever. The rigors started at 9pm on Wednesday, 20Jan2021. She stated that she couldn't do anything for the few hours it lasted. No other relevant diagnostic and confirmatory test results for events. No investigation assessment performed. The event did not require a visit to Emergency room or Physician office. The reported considered seriousness for fever was medically significant, for rigors was disabling. Outcome of fever was resolving. Outcome of rigors was resolved on 21Jan2021. Outcome of the other events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia and chills cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/20/2021,01/20/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Chills', 'Fatigue', 'Feeding disorder', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH, 1010843,VA,36.0,F,"She couldn't walk for 4 days; Migraine; Bone pain; skin hurt to the touch; Her skin even hurt to touch. She was sensitive all over.; Chest burning and hurting; Joint pain; extremely dizzy; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; arm was sore/soreness where they gave the vaccine on her arm all the sudden came back very suddenly; The lady that gave it was not gentle. She screamed.; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number EL1284) via an unspecified route of administration on 03Jan2021 at a single dose for covid-19 immunization. The patient had headaches in the past. The patient's concomitant medications were none. The patient got vaccine on the 03Jan2021 and her arm was sore, but she felt like this was normal, just like it would feel after a flu shot. Throughout the next week, she was extremely stressed for work. By Friday, which would have been 6 days later. She was feeling really off wellness wise. She was very fatigued, and extremely dizzy on 07Jan2021. On Saturday night 09Jan2021, she felt very bad. She had a sore throat, she was coughing, her chest was burning and hurting. She had severe chills and aches. She thought maybe she needed more sleep because she works out 6 days a week. She felt like she was in over drive like she was killing herself. Sunday morning 10Jan2021, she felt bad. She has so much adrenaline. She was always on the go. She decided to take a nap before the gym Sunday, and she woke up with a huge migraine. She had headaches in the past, but never a migraine. Her head was hurting so bad it woke her up. It hurt all over. She also felt like she had taken a hammer to her joints and bones. Her joints and bones were hurting. She has never felt that before. Her muscles were so achy. Her skin even hurt to touch. She was sensitive all over. She had severe chills. The soreness where they gave the vaccine on her arm all the sudden came back very suddenly. It came back the same day as the other symptoms started. They mostly started on the 09Jan2021, and then on the 10Jan2021 they were worse while migraine and bone hurting were occurred on 10Jan2021. She assumed there were subtle symptoms leading up to the 09Jan2021, but she just didn't realize it. That was a Saturday and Sunday. The lady that gave it was not gentle. She screamed. The side effects lasted at least 5 days after the 10Jan2021. On the 10Jan2021, she did not feel well so she got tested for COVID because her boss told her to. They tested her Flu, COVID, and strep. She only tested positive for COVID on 10Jan2021. She felt like she wouldn't be able to drive. She couldn't walk for 4 days. She felt most of the symptoms had gone away around 5 days after the 10th except fatigue, feeling dizzy, and headaches here and there. She also had a little coughing here and there. That started 09Jan2021 and was ongoing but improved. She got the vaccine because the doctor at her practice really encouraged her to get it done. She also thought if she ever wanted to travel that she might need it. She thought in the long run she might benefit from having the vaccine. She felt peer pressured honestly to get it because she was sketched out to get it at all. She wants to know the rate of people testing positive for COVID after getting the vaccine. The outcome of the events sore arm, chest burning, joint and bone pain, skin even hurt to touch and sensitive was recovered on 15Jan2021, the outcome of the events screamed and couldn't walk was unknown and the outcome of the other events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Headache,,,"['Arthralgia', 'Bone pain', 'COVID-19', 'Chest pain', 'Chills', 'Condition aggravated', 'Cough', 'Dizziness', 'Emotional distress', 'Fatigue', 'Feeling abnormal', 'Gait inability', 'Headache', 'Impaired driving ability', 'Influenza virus test negative', 'Injection site pain', 'Malaise', 'Migraine', 'Myalgia', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Paraesthesia', 'SARS-CoV-2 test positive', 'Screaming', 'Sensitive skin', 'Streptococcus test negative', 'Stress', 'Tenderness']",UNK,PFIZER\BIONTECH, 1010846,SD,84.0,F,"could not get her head around what day it was/ her brain was not working right; disoriented/disorientation; body not responding/she couldn't function; This is a spontaneous report from a contactable Other Health Professional (patient). An 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 by injection once to right deltoid (Batch/lot number: EL0142), second dose of BNT162B2 via an unspecified route of administration on 18Jan2021, both at single dose for COVID-19 immunization. There were no medical history and concomitant medications. Investigation Assessment: No. The patient had second her COVID shot, the vaccine, on 18Jan2021, and she is a very healthy 84 years old with no health problems, and she woke up on 19Jan2021, and was disoriented, she could not get her head around what day it was, this was so rare, she normally goes to the fitness center and excursuses, but her body was not responding, her brain was not working right, it was a strange ordeal, so she got in the shower, to get her circulation going, and she couldn't shower, she got all wet, and had to get out and lay on a towel, she couldn't function, it was very scary, and very atypical. Her disorientation went away by 10AM on 19Jan2021- she did not see anyone or go to a provider. Her body started not responding around 7:30 when she got up, and by 9 or 10AM, she was functioning again. The patient didn't think this was from vaccine, she had seen enough vaccine reactions to various vaccines, and this was not a vaccine reaction, she thought what is happening? Is this a stroke, or a vascular event, she has since recovered but was still very shook, anxious about what it was, what happened until an hour or so after, it was still under her. Causality: Unknown, she didn't think of the connection until someone else did, she was describing it and the other person said it was because of the vaccine, as this person was a skeptic and doesn't want the vaccine herself, and this was not a typical response, but then she got to thinking. The outcome of disoriented/disorientation and body not responding/she couldn't function was recovered on 19Jan2021, the other event was unknown. Seriousness: it was disabling at the time, she was concerned she had a stroke, she was checking her grasps and her face and legs, she was obsessing. Seriousness for disoriented/disorientation and body not responding/she couldn't function was disability. Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of serious events cannot be excluded, considering the plausible temporal relationship. The underlying medical conditions in the advanced old patient considered confounders. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Yes,Y,01/18/2021,01/19/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Abnormal behaviour', 'Disorientation', 'General physical condition abnormal']",2,PFIZER\BIONTECH, 1010847,NC,61.0,M,"acute hepatitis/The transaminase was elevated to four times the upper limit; Fever/temperature yesterday was 103 degrees/ Today it is 98 degrees; Fatigue; Myalgia; Malaise; This is a spontaneous report from a contactable pharmacist and a contactable consumer. A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Not at Military Facility. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed an acute hepatitis after receiving the second dose of the Covid-19 vaccine on 20Jan2021. The transaminase was elevated to four times the upper limit. The aspartate aminotransferase (AST) was 183 and alanine aminotransferase (ALT) was 270. The patient reported fever on 18Jan2021, fatigue on 16Jan2021, malaise on an unknown date in Jan2021 and myalgia on 16Jan2021. Events of acute hepatitis, Fever and Fatigue were assessed as serious due to medically significant and Myalgia was non-serious, the events of Fever, Fatigue and Myalgia were Related to Covid-19 vaccine, and unable to provide causality of acute hepatitis. Pharmacist was unable to confirm if the patient was still experiencing myalgia. The patient reported that he felt better today. His temperature yesterday (21Jan2021) was 103 degrees. Today (22Jan2021) it is 98 degrees. Adverse event required a visit to Physician Office. The patient underwent lab tests and procedures which included ALT: 270 on 20Jan2021, AST: 183 on 20Jan2021, alkaline phosphatase: 241 on 20Jan2021, body temperature: 103 degrees on 21Jan2021, body temperature: 98 degrees on 22Jan2021, serology test: negative on 20Jan2021. The outcome of the event acute hepatitis was not recovered, event Fever was recovered on 22Jan2021, event Fatigue was recovering and the events of Myalgia and Malaise was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events hepatitis acute, fever and fatigue. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/01/2021,,PVT,,,,,,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood alkaline phosphatase increased', 'Body temperature increased', 'Fatigue', 'Hepatitis acute', 'Hepatitis viral test negative', 'Malaise', 'Myalgia', 'Pyrexia', 'Transaminases increased', 'Viral test negative']",2,PFIZER\BIONTECH, 1010850,WI,25.0,F,"dizziness; increased heart rate; increased blood pressure; flushed; weakness; shakiness; lethargy; chilled; in particular hands were very cold; pale color; slurred speech; mental fog; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 25-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3249), via an unspecified route of administration at site of right arm on 20Jan2021 09:30 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included vitamin D3 and iron (SLOW RELEASE IRON) and daily multivitamin. Within minutes of receiving the dose on 20Jan2021 at 09:45 AM, dizziness, increased heart rate, increased blood pressure, flushed, weakness, and shakiness. About an hour after receiving the dose on 20Jan2021, lethargy, chilled, in particular hands were very cold, pale color, mental fog, and slurred speech. The patient did not receive any treatment from events. The outcome of events was recovered in Jan2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported temporary mental fog/mental impairment was likely related to first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/20/2021,0.0,PVT,VITAMIN D3; SLOW RELEASE IRON,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Blood pressure increased', 'Chills', 'Dizziness', 'Dysarthria', 'Feeling abnormal', 'Flushing', 'Heart rate increased', 'Lethargy', 'Pallor', 'Peripheral coldness', 'Tremor']",1,PFIZER\BIONTECH, 1010860,GA,40.0,F,"inflammatory response; had heart rate in 150's; nauseated all day; temp was 102; Both my knees were swollen; both legs were tingly; dizzy; very weak; shaky; This is a spontaneous report from a non-contactable consumer (patient). A 40-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included asthma, mitral valve, Known allergies: Sulfa, Shellfish, sulfide. No other vaccine in four weeks. No covid prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR) and Asthma inhalers. 6 hrs after vaccinated I became dizzy, very weak and shaky. Next day was nauseated all day, felt shaky, by 3 pm temp was 102, had heart rate in 150's. Both my knees were swollen, both legs were tingly. I took Motrin and Tylenol and most symptoms resolved by morning. Friday morning, I still felt weak but other symptoms resolved. I was not expecting the inflammatory response which is why I am letting y'all know. The patient underwent lab tests and procedures which included sars-cov-2 test via Nasal Swab: negative on 21Jan2021. The outcome of the event Very weak not recovered, inflammatory response was unknown and of the rest events was recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,UNK,ALLEGRA; SINGULAIR,,Medical History/Concurrent Conditions: Asthma; Drug allergy (Known allergies: sulfide); Drug allergy (Known allergies: Sulfa); Mitral valve disease; Shellfish allergy (Known allergies: Shellfish),,,"['Asthenia', 'Body temperature increased', 'Dizziness', 'Joint swelling', 'Nausea', 'Paraesthesia', 'SARS-CoV-2 test negative', 'Tremor']",1,PFIZER\BIONTECH, 1010869,MI,68.0,F,"blood shot right eye; Allergic reaction; Chills; Her lips are a pinkish color as if she is still having some type of reaction; She did have nausea this morning; This is a spontaneous report from a contactable consumer reporting for herself. A 68-years-old female patient received bnt162b2 (BNT162B2; Lot # EL1283) , via an unspecified route of administration on 21Jan2021 at single dose for Covid-19 immunisation . Medical history included cataract operation on 10Nov2020, oedema , swelling , brain operation on 2016 , aneurysm (aneurysm that did not rupture and there are 8 coils protecting that) , implantable cardiac monitor insertion , hypertension. Concomitant medication included lisinopril dihydrate (LISINOPRI)Lacetylsalicylic acid (ASPIRIN BAYER), amlodipine besilate (AMLODIPIN) pravastatin sodium (PRAVASTATIN) The patient experienced chills on 21Jan2021 with outcome of not recovered , her lips are a pinkish color as if she is still having some type of reaction on 21Jan2021 with outcome of not recovered , she did have nausea this morning on Jan2021 with outcome of unknown , blood shot right eye on 22Jan2021 with outcome of not recovered , she thinks she had an allergic reaction on 21Jan2021 with outcome of not recovered. The patient received Benadryl, Prednisolone and Ketorolac as treatment. Follow up information has ben requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/01/2021,,UNK,LISINOPRIL [LISINOPRIL DIHYDRATE]; ASPIRIN BAYER; AMLODIPIN [AMLODIPINE BESILATE]; PRAVASTATIN [PRAVASTATIN SODIUM],,Medical History/Concurrent Conditions: Aneurysm (aneurysm that did not rupture and there are 8 coils protecting that); Blood pressure high; Brain operation; Cataract operation; Edema; Implantable loop recorder; Swelling,,,"['Chills', 'Hypersensitivity', 'Lip erythema', 'Nausea', 'Ocular hyperaemia', 'Pallor']",UNK,PFIZER\BIONTECH, 1010875,,,F,"Visual hallucinations /I began to hallucinate colors on phone; This is a spontaneous report from a non-contactable consumer. A 22-year-old female consumer reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN5318), at single dose on an unknown date for COVID-19 immunization. Medical history and concomitant drugs were unknown. The patient reported that immediately after receiving the vaccine she went on her phone in the area where patients had to be held for 15 minutes to be monitored for severe reactions. She began to hallucinate colors on her Smartphone that she knew don't belong. She was seeing purple and light blue outlines around the (messaging app name) bubbles and they looked real. This lasted for about 30 minutes. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Hallucination, visual']",UNK,PFIZER\BIONTECH, 1010877,,,U,"they tested another one and it was positive; they tested another one and it was positive; This is a spontaneous report from a contactable consumer living in a residence of assisted living. A patient of unspecified age and gender received COVID-19 Vaccine (unsure if BNT162B2 Pfizer-BioNTech or Moderna vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, on an unknown date after vaccination, the patient was tested for COVID-19 and was positive. The event onset date and outcome were unknown at the time of the report. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1010879,,,U,"feeling funny; anxiety attacks; nervous; Headache; Nauseous; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient experienced feeling funny, anxiety attacks and nervous on 16Jan2021, and went to emergency room due to feeling funny, anxiety attacks and nervous, patient also experienced headaches, went to physician office visit and a little nauseous in Jan2021. It was reported that patient received the first shot on 16Jan2021. Immediately after the shot went in(16Jan2021), patient started feeling funny. So, patient was right in the hospital anyway, patient just went to the emergency room and they checked patient up and they just gave patient prednisone, patient do not know why they gave patient Prednisone thinking patient was having anxiety attacks or something and they did an Electrocardiogram(EKG) said patient was fine. Patient took the Prednisone a couple of days because it made patient nervous but patient was still having headaches and a little nauseous and its since Saturday, last Saturday. Treatment received for all events. Outcome of headache and nauseous was not recovered, of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/01/2021,,UNK,,,,,,"['Anxiety', 'Electrocardiogram normal', 'Feeling abnormal', 'Headache', 'Nausea', 'Nervousness']",1,PFIZER\BIONTECH, 1010889,PA,,F,"I was taken to the ER because I started with numbness in my face and itching; I was taken to the ER because I started with numbness in my face and itching; Terrible headache; Sore throat; Chills; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3302), via an unspecified route of administration at site of left arm on an unspecified date at single dose for COVID-19 immunization. Medical history included blood pressure high and thyroid problems. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid problems, spironolactone. The patient just had side effects from the Covid Vaccine (clarified as Pfizer BioNTech Covid Vaccine). Actually when the patient had the shot she was taken to the ER because she started with numbness in face and itching on unknown date but now since that was on Tuesday 19th, so today the patient had a terrible headache, she had sore throat and today she started with chills on unknown date. Before the patient had blood drawn latest before she got shot. The patient was in the hospital, she was given Benadryl, Pepcid and steroid through the IV. The patient had been treating in home with either Tylenol, Ibuprofen, Excedrin Migraine, Aleve, she mean, trying to relief the headache and it's not helping. The outcome of events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,SYNTHROID; SPIRONOLACTONE,,Medical History/Concurrent Conditions: Blood pressure high (Verbatim: Blood pressure high); Thyroid disorder,,,"['Chills', 'Headache', 'Hypoaesthesia', 'Oropharyngeal pain', 'Pruritus']",UNK,PFIZER\BIONTECH, 1010890,NC,45.0,M,"Local nerve injury/significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work; At the time of vaccination he experienced discomfort in left deltoid which was the injection site; Cannot lift his arm greater than 45 degrees; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; This is a spontaneous report from a contactable pharmacist. A 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular n deltoid left on 09Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. At the time of vaccination he experienced discomfort in left deltoid which was the injection site, cannot lift his arm greater than 45 degrees, local nerve injury, systemic fatigue ,myalgia and other arthralgia for 24-36 hours, developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work or task, all in Jan2021 with outcome of unknown. He called the employee health on 17Jan2021 and 19Jan2021 he saw a neurosurgeon. The neurosurgeon didn't think it was a cervical spine injury rather a local nerve injury related to the injection itself and he was prescribed a steroids taper, unclear whether if it was a temporary or permanent issue. Because this was like 10 days after the vaccine and he didn't really describe how much this issue affected his ability to perform usual work or task but he was a surgeon. The outcome of the events were unknown.; Sender's Comments: Based on the compatible time association, the peripheral nerve injury is possibly related to the injection technique, not vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/01/2021,,OTH,,,,,,"['Arthralgia', 'Fatigue', 'Hypoaesthesia', 'Impaired work ability', 'Injected limb mobility decreased', 'Injection site discomfort', 'Injection site muscle weakness', 'Injection site nerve damage', 'Local reaction', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Muscular weakness', 'Myalgia', 'Nerve injury', 'Peripheral nerve injury']",2,PFIZER\BIONTECH,OT 1010891,IN,73.0,F,"Pneumonia; She increasingly today has not been able to take straight steps forward, she walks like she is drunk; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL8982), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization, pregabalin (LYRICA, Pfizer product), phenytoin sodium (DILANTIN, Pfizer product), levetiracetam (KEPPRA, non-Pfizer product), all via an unspecified route of administration from an unspecified date at unspecified dose for an unspecified indication. Medical history included Major Epilepsy issues from an unknown date and unknown if ongoing. Concomitant medication included sertraline hydrochloride (Generic of Zoloft). The patient got the shot, she had no pain or anything like that but she increasingly today has not been able to take straight steps forward, she walks like she is drunk. She is on Lyrica, she is on Dilantin and she is on Keppra and the reporter was wondering if there is any relationship between the actions we are seeing from her today from the shot and concerned if that could be a reaction. The patient did not have the second dose yet. The patient had pneumonia in Dec so she was checking for potassium levels but the reporter didn't know if the patient did a CBC or what other. Treatment: Reporter stated, ""It just started today."" The patient underwent lab tests and procedures which included potassium levels and blood work with unknown results. The action taken in response to the events for pregabalin, phenytoin sodium and levetiracetam was unknown. The outcome of all the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,,,UNK,SERTRALINE HYDROCHLORIDE; LYRICA; DILANTIN; KEPPRA,,Medical History/Concurrent Conditions: Epilepsy,,,"['Blood potassium', 'Blood test', 'Gait disturbance']",1,PFIZER\BIONTECH, 1010899,,,M,"On the two people who died, one in (State name) and one in (State name); This is a spontaneous report from a contactable other HCP. This other HCP reported similar events for 2 patients. This is 1 of 2 report. An unknown age male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecific date at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. It was reported that patient was died. Cause of death unknown. Outcome of the event was fatal. Information on the lot/batch number has been requested.; Sender's Comments: Death with unknown cause is considered related to BNT162B2 for reporting purpose. Information is very limited. Case will be reassessed once receiving additional information, including cause of death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021102049 same reporter/drug/event, different patient; Reported Cause(s) of Death: On the two people who died, one in (State name) and one in (State name)",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],UNK,PFIZER\BIONTECH, 1010900,,,M,"patient died; This is a spontaneous report from a contactable Other Healthcare Professional (HCP). This Other HCP reported similar event for 2 patients. This is 2nd of 2 reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient died on an unspecified date. Cause of death unknown. Outcome of the event was fatal. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021102020 same reporter/drug/event, different patient; Reported Cause(s) of Death: patient died",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],UNK,PFIZER\BIONTECH, 1010901,FL,72.0,F,"Passed out; Little bit sore arm; I woke up, was not able to sleep; My heart was doing kind of flip floppy; Dizzy/ had the dizziness which was severe; Falling; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL1283), via an unspecified route of administration on 20Jan2021 at 08:00 AM at single dose because she would like to not get Covid 19. Medical history reported as no. Concomitant medication included levothyroxine. The patient reported that she had bnt162b2 shot on Wednesday the 20Jan2021 about 8 O'clock in the morning, no real problem when she had it, had little bit sore arm but this morning (in Jan2021) about 2 O'clock she woke up, was not able to sleep, moved around a bit, her heart was doing kind of flip floppy, was not thinking much, the next thing she knew, she was extremely dizzy and she passed out, patient was asking could that be a side effect of Covid 19, it was about 36 hours after she had the shot. Patient also stated falling and passing out kind of get you off key. She had the dizziness which was severe and did pass out in Jan2021. No investigation assessment. No treatment was received for the events. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/01/2021,,UNK,LEVOTHYROXINE,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dizziness', 'Fall', 'Insomnia', 'Loss of consciousness', 'Pain in extremity', 'Palpitations']",UNK,PFIZER\BIONTECH, 1010903,MA,,U,"Got Pfizer dose and then they tested positive; Dues for second dose but don't get it because they are positive; Got Pfizer dose and then they tested positive; Dues for second dose but don't get it because they are positive; This is a spontaneous report from a contactable Pharmacist. A patient of unspecified age and gender received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 28Dec2020 at SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got pfizer dose and then they tested positive; dues for second dose but don't get it because they are positive on 11Jan2021. Outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 on 28Dec2020, and was diagnosed with COVID-19 on11Jan2021. No complete effect could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. The positive COVID-19 is more likely pre-existing/intercurrent condition, and unrelated to BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,01/11/2021,14.0,UNK,,,,,,"['COVID-19', 'Incomplete course of vaccination', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1010904,,,U,"Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration from an unspecified date to an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced bell's palsy on an unspecified date with outcome of unknown. It was reported that the patient had a Bell's palsy a week afterwards and he/she ended up in hospital for a couple of days (unspecified). The patient asked if he/she should take the second dosage because today was the day that she was supposed to get the second one. Information on lot number/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,['Facial paralysis'],1,PFIZER\BIONTECH, 1010905,MO,33.0,F,"nipples are more sensitive/tender; increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes/gotten more noticeable since the second vaccine; increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes/gotten more noticeable since the second vaccine; This is a spontaneous report from a contactable consumer. A 33-year-old female patient (not pregnant) received her second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot EL9261), via an unspecified route of administration in right arm 20Jan2021 13:00 at SINGLE DOSE for Covid-19 immunisation . The patient's medical history was not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Covid-19 prior to vaccination, not been tested for COVID-19 prior to vaccination. Concomitant medications were not reported. She had her first dose of bnt162b2 (lot EJ1686) on 30Dec2020 via unknown route in the right arm. The patient's concomitant medications were not reported. She reported an increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes since the first vaccine (Dec2020) but it has gotten more noticeable since the second vaccine. She has also reported that her nipples are more sensitive/tender since vaccination (20Jan2021). No treatment was given to the events. The outcome of events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,12/01/2020,,PVT,,,,,,"['Neuropathy peripheral', 'Nipple pain', 'Sensory disturbance', 'Temperature intolerance']",2,PFIZER\BIONTECH, 1010906,NC,71.0,F,"Anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 19Jan2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 22Jan2021, the patient developed an anaphylactic reaction. She went to the doctor and he was reluctant to give her steroids which was the normal way of treating the anaphylactic reactions because he said that the steroid would interfere with the effect of the vaccine. So, he gave her diphenhydramine hydrochloride (BENADRYL). She had to go back to the emergency room later that day and they used epinephrine (EPIPEN) and she had to have an intravenous (IV) and other than that some medications, it had prednisolone in it. Then she had to go back yesterday and she had another IV and they sent her home with an EPIPEN. The event was assessed serious as medically significant. The patient had recovered from the event in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/22/2021,3.0,UNK,,,,,,['Anaphylactic reaction'],UNK,PFIZER\BIONTECH, 1010910,FL,71.0,F,"Dizziness, tightness in back of neck, tightness both sides of throat, tightness in TMJ both sides immediately and over the next 30-40 minutes. Pink donut shaped 3 inch diameter patch at injection site the next day. Immediate reactions resolved within the 40 minute period.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,OTH,"lisinopril, vitamins, minerals",none,"hypothyroid, two heart murmurs, many orthopedic issues from auto accident, diminished vision and hearing",,"penicillin, sulfa, quinine, red kidney beans","['Dizziness', 'Injection site erythema', 'Muscle tightness', 'Throat tightness']",UNK,MODERNA,IM 1010911,,63.0,F,"Patient woke up Saturday, 6 Feb, with multiple small raised welts on left shoulder around injection site. Site was itchy. Over the course of the day, site enlarged slightly with a little warmth, but nontender. That day, took a dose of Benadryl and applied topical Hydrocortisone. On Sunday, 7 Feb, area began to improve and applied more Hydrocortisone and took additional Benadryl . Pt stopped her Allegra these 2 days as she was not sure if could take all meds together. On Monday, 8 Feb, patient walked into our Allergy/Immunizations clinic (protocol for anyone who receives an injection and has concerns about a reaction) at our facility and I examined the area with very faint residual erythema, but nonpalpable and nontender. No further itching by Sunday night.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,02/06/2021,8.0,MIL,Patient on Allegra 180mg daily for seasonal allergies and Astelin nasal spray every morning.,None,,,Sulfa drugs - Delayed drug eruption at 9 days nearly 20 years ago,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth', 'Urticaria']",1,MODERNA,IM 1010912,NY,82.0,F,"Redness and heat on R foot, left after 15 minutes. Upset bowel system. Have always had opposite problem.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/29/2021,02/08/2021,10.0,OTH,"thyroid 05 grain, Alendronate sodium tablet, Ginkgo Biloba, M.C.H.C caps, Cogni-zone mag, Vit. E, Mag. K, B12, MacuGard with Astaxanthin, Biotin, Zinc citrate, L-Theanine, Lutein, liquid D3.",None.,None,,None.,"['Abdominal discomfort', 'Erythema', 'Feeling hot']",1,PFIZER\BIONTECH, 1010980,MA,25.0,F,"Brain hemorrhage (inflammation, swelling); Dizziness; Difficulty with coordination; Difficulty with balance; Vision changes in left eye; Drift in left arm; Issues going through daily routine; Neurological symptoms; Was confused; Headaches; Very nauseous; A spontaneous report was received from a consumer, who was a 25-years-old, white female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, very nauseous, neurological symptoms, headaches, dizziness, difficulty with coordination, difficulty with balance, vision changes in left eye, drift in left arm, issues going through daily routine, confusion, and brain bleed. The patient's medical history, as provided by the reporter, included gluten allergy. Products known to have been used by the patient, within two weeks prior to the event, included ethinylestradiol/ ferrous fumarate/ norethindrone acetate. On 06 Jan 2021 at 10:30am, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 06 Jan 2021, after receiving the vaccine, the patient became very nauseous through 08 Jan 2021. On 09 Jan 2021, the patient started having neurological symptoms. She started having headaches, dizziness, difficulty with coordination and balance, and vision changes in the left eye (not specified). She reported that she had a ""drift"" in the left arm and described it as ""when you try to manipulate the arm, but it does not go where you want it to go"". On 11 Jan 2021, the patient still had neurological symptoms, issues moving left arm, colliding with objects all day, and issues going through daily routine. On 12 Jan 2021, the patient was seen by a neurologist and magnetic resonance imagining (MRI) was scheduled. The MRI revealed inflammation, and brain bleed and swelling. The patient was sent to the emergency room and admitted on 19 Jan 2021. Treatment for the events included calcium carbonate for nausea, ibuprofen for headaches and diphenhydramine. Action taken with mRNA-1273 in response to the events was not reported. The event, very nauseous, was considered resolved on 08 Jan 2021. The events, neurological symptoms, headaches, dizziness, difficulty with coordination, difficulty with balance, vision changes in left eye, drift in left arm and issues going through daily routine, confusion, and brain bleed were considered not resolved. Follow-up received on 23 Jan 2021 included patient details, medical history, lab tests, concomitant medications, hospitalization, and updated events.; Reporter's Comments: This case concerns a female patient, who experienced a non-serious unexpected event of dizziness, coordination abnormal, balance disorder, visual impairment, movement disorder, loss of personal independence in daily activities, and neurological symptom, and non-serious expected event of nausea, and headaches. The events of nausea occurred 1 day (same day) after first dose of mRNA-1273, lot # unknown. The event of neurological symptoms, dizziness, coordination abnormal, balance disorder, visual impairment, loss of personal independence in daily activities, and movement disorder occurred 3 days after first dose of mRNA-1273, lot # unknown. Treatment for the events included, Tums, nauseam, ibuprofen and Benadryl. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/06/2021,01/06/2021,0.0,UNK,,Gluten sensitivity (Gluten allergy),,,,"['Balance disorder', 'Brain oedema', 'Cerebral haemorrhage', 'Confusional state', 'Coordination abnormal', 'Dizziness', 'Dyskinesia', 'Gait disturbance', 'Headache', 'Inflammation', 'Loss of personal independence in daily activities', 'Magnetic resonance imaging abnormal', 'Movement disorder', 'Nausea', 'Neurological symptom', 'Noninfective encephalitis', 'Visual impairment']",1,MODERNA,OT 1010981,,,U,"Potential Guillain-Barre; A spontaneous report was received from a pharmacist concerning an unknown patient who received Moderna's COVID-19 vaccine and potentially developed Guillain-Barre Syndrome. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 19 Jan 2021, the patient is in the hospital for potential Guillain-Barre Syndrome. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, potential Guillain-Barre Syndrome, was unknown/ not reported.; Reporter's Comments: This case concerns a patient of unknown age and gender, who experienced a serious unexpected event of potential Guillain-Barre Syndrome which required hospitalization. The event occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Treatment details were not provided. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,,01/19/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Guillain-Barre syndrome'],1,MODERNA,OT 1010982,,,F,"Arrhythmias; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who experienced arrhythmias. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. Prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. Patient had adverse heart reaction after receiving the vaccination. Patient has some arrhythmias and ended up in the ER two days later. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the events, adverse heart reaction and arrhythmias were not reported.; Reporter's Comments: This case concerns a female patient of unknown age with unknown medical history subject, who experienced a serious unexpected event of arrhythmia. The event occurred on unspecified time after the first dose of mRNA-1273 vaccine (but not later than 2 days after vaccination). Treatment information was reported; however, patient was sent to emergency room. Outcome of reported arrhythmia is unknown. The event was assessed as possibly related, however additional information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Arrhythmia', 'Cardiac disorder']",1,MODERNA,OT 1010983,GA,,F,"Pancytopenia; Malaise; Muscle aches; Fever; A spontaneous report was received from a physician concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pancytopenia, fever, malaise, and muscle aches. There was no medical history provided. There were no concomitant medications provided. On 16 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Batch # unknown), for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient experienced the serious event of pancytopenia. Additionally, on an unspecified date in Jan 2021, following in jection, the patient experienced the non-serious events of fever, malaise, and muscle aches. Relevant laboratory result included platelet count of 1000 and hemoglobin was decreased on 22 Jan 2021. There was no treatment information provided. Action taken with mRNA-1273 in response to the events of pancytopenia, fever, malaise, and muscle aches, was not provided. The event of pancytopenia was unknown. The outcome for the events fever, malaise, and muscle aches, was unknown at the time of this report.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of pancytopenia and non-serious unexpected event of malaise, non-serious expected events of myalgia, and pyrexia. The event of pancytopenia occurred 7 days after first dose of mRNA-1273, lot # unknown. The event of myalgia and pyrexia occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Treatment was not specified. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Haemoglobin decreased', 'Malaise', 'Myalgia', 'Pancytopenia', 'Platelet count decreased', 'Pyrexia']",1,MODERNA,OT 1010984,NJ,,F,"Subcutaneous Injection; lump at injection site; A spontaneous report was received from a nurse concerning a 65-year old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) via subcutaneous injection and experienced lump at injection site. No relevant medical history and concomitant medications were reported. On 20-Jan-2021, prior to the onset of the events, the patient received a dose of mRNA-1273 (lot number 032L20A) subcutaneously for prophylaxis of COVID-19 infection. On 20-Jan-2021, the patient developed a lump at the injection site when vaccine was given to her subcutaneously. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not reported. The event subcutaneous injection was considered to be resolved on 20-Jan-2021. The outcome of event lump at injection site was unknown.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273, lot #: 032L20A. There were no reported AEs associated with this case of incorrect route of product administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/20/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Incorrect route of product administration', 'Injection site mass']",1,MODERNA,OT 1010985,,,F,"Lungs congested; Trouble breathing; Trouble speaking/Trouble breathing; When she would speak she would cough hard; A spontaneous report was received from a consumer concerning a 65-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced trouble breathing, trouble speaking, lungs congested and when she would speak she would cough hard. The patient's medical history included back pain being treated by a pain management doctor, high blood pressure, high cholesterol, asthma and diabetes. Medications reported by the patient, within two weeks prior to the event, included albuterol inhaler. On 18 Jan 2021, in the morning, the patient received their first of two planned doses of mRNA-1273 (Lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection. On 18 Jan 2021, in the evening on the same day of vaccination, the patient went to the ER (emergency room) due to trouble breathing and speaking, lungs congested, and cough when she would speak. While in the ER she had a blood test, chest x-ray, and an EKG which all came back normal. She stated that she did not think that the symptoms were related to an environmental change. Treatment for the event included steroid and nebulizer treatment, and the symptoms resolved after treatment on the same day. Action taken with mRNA-1273 in response to the events was not provided. The outcomes of the events were resolved on 18 Jan 2021.; Reporter's Comments: This case concerns a 66-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 028L20A), and who experienced the serious unlisted event of lungs congested, and the non-serious unlisted events of trouble breathing, trouble speaking, and cough. The events occurred on the day of vaccination. Based on the current available information and temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/18/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Asthma; Back pain; Blood pressure high; Diabetes; High cholesterol,,,"['Aphasia', 'Asthma', 'Back pain', 'Blood cholesterol increased', 'Blood test normal', 'Chest X-ray normal', 'Cough', 'Diabetes mellitus', 'Dyspnoea', 'Electrocardiogram normal', 'Hypertension', 'Pulmonary congestion', 'Speech disorder']",1,MODERNA,OT 1010986,CA,,F,"Bad heart rate; sore arm; A spontaneous report was received from a nurse who was also a 77-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and bad heart rate. The patient's medical history was not provided. No concomitant medications were reported. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient developed a sore arm. No treatment was administered. On 10 Jan 2021, the patient experienced bad heart rate and had to go to the emergency room (ER). On 21 Jan 2021, the patient had a second visit to the ER, where she required a cardioversion for the bad heart rate. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the event, sore arm, was resolved on an unknown date. The outcome for the event, bad heart rate, was resolved on 21 Jan 2021.; Reporter's Comments: This case concerns a 77-year-old female patient, who experienced a medically significant unexpected event of Heart rate abnormal and unexpected non-serious event of Pain in extremity. The medical history is not provided. The event of Pain in extremity occurred on the same day after receiving their first of two planned doses of mRNA-1273 (Lot # 025L20A). The event of Heart rate abnormal occurred approximately five days after receiving their first of two planned doses of mRNA-1273 (Lot # 025L20A). Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Cardioversion', 'Heart rate abnormal', 'Pain in extremity']",1,MODERNA,OT 1010987,,,U,"Angioedema both times, the second time was a little bit worse; A spontaneous report was received from a healthcare facility staff member concerning an unknown patient who received Moderna's COVID-19 Vaccine, and who experienced angioedema after both doses. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On unknown date, prior to the onset of the symptoms, the patient received their two planned doses of mRNA-1273 unknown batch number intramuscularly for prophylaxis of COVID-19 infection. On unknown date, the patient experienced angioedema both times after vaccination. The second time was a little bit worse and lasted for three days. Treatment for the event included prednisolone, Pepcid and Benadryl. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The outcome of the event angioedema both times not reported.; Reporter's Comments: This case concerns a patient who received their two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of angioedema after both doses. Based on the current available information, including reoccurrence of event after second dose and temporal association between the use of the product and the onset of event after vaccination, a causal relationship cannot be excluded and the event of angioedema is considered possibly related to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Angioedema', 'Vaccine positive rechallenge']",2,MODERNA,OT 1010989,FL,69.0,F,"Brain aneurysm; Anaphylactic reaction; Collapsed; BP sky rocketed; Shortness of breath; A spontaneous report was received from a consumer concerning a 69-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced blood pressure skyrocketed, shortness of breath, loss of consciousness, massive anaphylactic reaction, and brain aneurysm. The patient's medical history, as provided by the reporter, included high blood pressure and arthritis. Products known to have been used by the patient, within two weeks prior to the event, included an antihypertensive. On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. Twenty-two minutes later she had a massive anaphylactic reaction. She experienced shortness of breath, blood pressure skyrocketed, and loss of consciousness. She was taken to the emergency room. The patient had a brain aneurysm and never recovered. No treatment information was provided. The patient died on 04 Jan 2021. The cause of death was reported as brain aneurysm. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a 69-year-old, female patient with a medical history of hypertension, who experienced fatal, serious, unexpected events of Anaphylactic reaction, hypertension, dyspnea, loss of consciousness and brain aneurysm. The events occurred 22 minutes after the first dose of mRNA-1273 was administered. No treatment information was provided. The patient never recovered and died. The cause of death was reported as brain aneurysm. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested.; Reported Cause(s) of Death: Brain aneurysm",Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/04/2021,0.0,UNK,,Arthritis; Hypertension,,,,"['Anaphylactic reaction', 'Death', 'Dyspnoea', 'Hypertension', 'Intracranial aneurysm', 'Loss of consciousness']",1,MODERNA,OT 1010990,WA,52.0,F,"Colitis; A spontaneous report was received from a 52-year-old, female consumer, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed colitis. The patient's medical history was not provided. Concomitant product reported included ogmentin. On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) in the right arm for prophylaxis of COVID-19 infection. The patient experienced weight loss and was unable to eat after receiving the first dose. On 15 Jan 2021, the patient reported that she started to experience lower pelvic pain and was diagnosed with colitis. On 21 Jan 2021, she had a follow up with PCP (primary care physician) and the PCP advised not to get second dose until 29 Jan 2021. On an unspecified date, she started her new antibiotic treatments. Treatment for the event included levosloxacin. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, colitis, was not reported.; Reporter's Comments: This case concerns a 52 year-old, female patient, who experienced event of colitis. The event of colitis occurred 16 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/15/2021,15.0,UNK,OGMENTININE,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Colitis', 'Feeding disorder', 'Pelvic pain', 'Weight decreased']",1,MODERNA,OT 1010992,NY,63.0,F,"My face started feeling very hot / feeling warm; my arms were looking mottled; first got hives under my neck on the left side and then it traveled to the tight side of my neck/ had hives on my arms legs neck chest and back; within 5 more minutes my neck was red / my face started getting red; This is a spontaneous report from a contactable Health Professional, the patient. A 63-year-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3242), via intramuscular route in the left arm on 22Jan2021 17:00 (at the age of 63-years) as a single dose for COVID-19 immunization. Medical history included Thyroid -Hashimoto's thyroiditis, Penicillin allergy, Brussels sprouts and avocados allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine and ibuprofen (ADVIL). The patient previously took erythromycin and experienced allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 22Jan2021 at 17:15, after approximately 10 minutes of receiving vaccination, the patient started feeling warm, she noticed her arms were looking mottled and she went to the nurse. She first got hives under her neck on the left side and then it traveled to the tight side of my neck. Within 5 more minutes her neck was red, and her face had started feeling very hot. Her face started getting red. The patient was taken to the emergency room and she had hives on her arms, legs, neck, chest, and back. The patient was treated for feeling very hot, arms mottled, hives, and neck and face red with intravenous (IV) Benadryl 50mg with Famotidine IV and saline solution IV. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event for feeling very hot, arms mottled, hives, and neck and face red were recovered in Jan2021; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to the events is possible . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,PVT,LEVOTHYROXINE; ADVIL [IBUPROFEN],,Medical History/Concurrent Conditions: Food allergy; Fruit allergy; Hashimoto's thyroiditis; Penicillin allergy,,,"['Erythema', 'Feeling hot', 'Livedo reticularis', 'Urticaria']",UNK,PFIZER\BIONTECH,OT 1010993,VA,56.0,F,"my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; itching and got hives; itching and got hives; This is a spontaneous report from a contactable Nurse reported for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 16:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient was not pregnant. Medical history included Asthma, food and environmental allergies, allergy to PCN and Sulfa. Concomitant medications included montelukast sodium (SINGULAIR), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), loratadine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of BNT162B2 on an unknown date for covid-19 immunization. The patient previously took acetylsalicylic acid (ASA), levofloxacin (LEVAQUIN), codeine and azithromycin (ZITHROMAX) and experienced allergy. 8 minutes after the vaccine was given on 22Jan2021 16:08, patient started itching and got hives. She was given Benadryl. About 5 minutes after that on 22Jan2021 16:13, her lips and tongue started itching and got swollen. At that time she was given an injection of Epinephrine and transferred to the Emergency Department. The outcome of the events was recovered on an unknown date in Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Pfizer comment: Based on the information currently available, a possible contributory role of the BNT162B2 in the reported events lip and tongue itching and got swollen cannot be excluded in this 56 years old female patient, who with medical history of allergy to food, environment and multiple medications. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,PVT,SINGULAIR; WELLBUTRIN; LEXAPRO; LORATADINE,,Medical History/Concurrent Conditions: Asthma; Environmental allergy; Food allergy (Food and environmental allergies); Penicillin allergy; Sulfonamide allergy,,,"['Lip pruritus', 'Lip swelling', 'Oral pruritus', 'Pruritus', 'Swollen tongue', 'Tongue pruritus', 'Urticaria']",2,PFIZER\BIONTECH, 1010994,PA,21.0,F,"Took pulse and it was 152; stumbling walking; mild dizziness/dizziness turned severe; Mild breathing problems/continued breathing issues; pressure on chest; This is a spontaneous report from a contactable Other Health Professional (patient). A 21-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 9231), via an unspecified route of administration on 21Jan2021 16:15 at single dose in Right arm for COVID-19 immunisation. Medical history included asthma, anxiety, and depression, all from an unknown date. Concomitant medication included duloxetine, lamotrigine, buspirone hydrochloride (BUSPAR), etonogestrel (NEXPLANON), ethinylestradiol, norethisterone acetate (JUNEL) in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 31Dec2020 02:30 PM in Right arm at single dose for COVID -19 immunisation and was tested positive for COVID on 01Jan2021; took cefdinir and experienced drug hypersensitivity. The patient reported symptoms began 12 hours after second COVID vaccine (5am on 22Jan2021). Mild breathing problems and pressure on chest. At 7am on 22Jan2021, mild dizziness started and continued breathing issues. At 12pm (noon) dizziness turned severe, was stumbling walking. Took pulse and it was 152 on 22Jan2021, checked several times. The patient went to the ER (Emergency room) and was determined it was a reaction to the vaccine. After receiving medication and fluids, pulse returned to normal after about seven or eight hours. The events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Covid-19 tested Positive on 01Jan2021, Pulse rate: 152 on 22Jan2021, Pulse rate returned to normal in Jan2021, heart ultrasound and EKG (Electrocardiogram) with unknown results in Jan2021. The patient received Fluids and medication as treatment. COVID was not tested post vaccination. The outcome of event Took pulse and it was 152 was recovered on an unspecified date in Jan2021. The outcome of the other events was recovering.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events are possibly related to suspect vaccine BNT162B2 injection. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/22/2021,1.0,UNK,DULOXETINE; LAMOTRIGINE; BUSPAR; NEXPLANON; JUNEL,,Medical History/Concurrent Conditions: Anxiety; Asthma; Depression,,,"['Chest discomfort', 'Dizziness', 'Dyspnoea', 'Echocardiogram', 'Electrocardiogram', 'Gait disturbance']",2,PFIZER\BIONTECH, 1011000,TX,37.0,F,"head ache, nausea, fever, chills, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/04/2021,0.0,MIL,"Zoloft, Vitamin D3, Prenatal vitamin, Fish oil",none,"anxiety, depression",,NKA,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,IM 1011001,OH,54.0,F,"9 days after vaccine was received in the left arm , there was swelling , redness , warmth and pain at the site . I took 600mg Ibuprofen every 6 hours for about 30 hours and I placed ice at the site frequently. I saw my PA next day and I was prescribed a Medrol pack , which helped resolve all those symptoms after first day of taking the medication.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/20/2021,8.0,PVT,None,None,HTN,,None,"['Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling', 'Vaccination site warmth']",UNK,MODERNA, 1011002,IN,74.0,F,"Fever and chills starting 12 hours after injection. Temperature 101.7 then and now 5 hours later! Unable to sleep, restlessness! Lower legs itch. Site is sore! Had been to to not take ibuprofen or Tylenol to help antibodies form! Can I take Benadryl? I had none of these adverse effects with 1st dose!",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/07/2021,02/08/2021,1.0,PVT,"Lisinopril, Cardura, Diltiazem ER, Spirolactolone, Lexapro, Prilosec, Livalo, Xarelto Calcium, Vitamin D, Magnesium, Multiple Vitamins, Zinc, Fish oil, Turmeric, CBD oil. Prolia","Hypertension, Preserved Ejection Fraction Heart Failure, osteoporosis, HEREafter vaccination. Fever 101.7 chills. Sore site, restlessness! No adverse reactions with 1st vaccination 1/17/21",Same,,"Penicillin, Sulfa","['Chills', 'Insomnia', 'Pruritus', 'Pyrexia', 'Restlessness', 'Vaccination site discomfort']",2,PFIZER\BIONTECH,IM 1011003,MN,52.0,F,"I had some swelling and pain the first two days following the vaccine, then all was fine. On day 8 I awoke to a large (2.5 inch) hard, red, itchy, hot welt at the injection site. There is mild pain when I touch it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/07/2021,8.0,OTH,"Cymbalta, Abilify, Trazodone, Litium, Wellbutrin, Buspar Vitamin C, AREDS vitamins, Elderberry chews",none,none,,none,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Pain', 'Swelling']",1,MODERNA,IM 1011005,NY,26.0,F,"Body aches, muscle weakness around midnight Fever at 6am",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/08/2021,1.0,SCH,"Wellbutrin, adderall",N/a,N/a,,Sulfa,"['Muscular weakness', 'Pain', 'Pyrexia']",2,MODERNA, 1011006,FL,71.0,F,"Patient stated her lips and tongue feel itchy. Patient stated she is allergic to shellfish and gets anxious every time she gets a vaccine. Vital signs within normal limits. BP 128/74, HR 68, O2 sat 96%. Patient took her own Benedryl PO. Patient stated she is feeling better, and she wants to go home.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/05/2021,02/05/2021,0.0,UNK,None,None,,,Shellfish,"['Anxiety', 'Tongue pruritus']",1,PFIZER\BIONTECH,IM 1011007,OH,59.0,F,"Pt complaint of dizziness 2 minutes after getting the vaccine. Pt the stated her vision was blurry. BP 200/130 Pt stated she was feeling better. Medic rechecked BP 247-200/130. Medic rechecked 191/119, HR 68 @ 1310 Pt advised to go to ER. Pt doesn't want to go by squad. States she will call her daughter 1332 RN still monitoring pt. Pt sitting quietly waiting on her daughter to take her to ER as advised by medic. 1337 daughter of pt arrived. Rn supervisor walked pt to meet daughter and advised daughter take her to ER ASAP and to pull over squad if worsen. Pt advised to go to ER by medics & RN due to elevated BP, blurred vision, & dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,OTH,,,,,,"['Blood pressure increased', 'Dizziness', 'Vision blurred']",UNK,PFIZER\BIONTECH,IM 1011010,IN,31.0,F,"Headache, growing inflammation under injection site-bottom of muscle",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,PVT,"Sertraline, trazodone",N/a,N/a,"First covid 19 dose-1/07/21, chills and fatigue.",N/a,"['Headache', 'Injection site inflammation']",2,MODERNA, 1011011,TN,72.0,F,"headache, rapid heart rate for several hours (160s), nausea, joint aches, chills, dizziness, weakness. Worst part lasted 48 hours. The nearest ER is an hour away so just pushed thru it.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/05/2021,1.0,PUB,,none,none,,"Morphine, Codeine, most pain meds","['Arthralgia', 'Asthenia', 'Chills', 'Dizziness', 'Headache', 'Nausea', 'Tachycardia']",UNK,MODERNA, 1011012,FL,67.0,F,"15 minutes after client received vaccine client stated that she felt dizzy and weak. Vital signs obtained by EMS BP 119/72, Pulse 72, Temp 99, O2 sat 96% Blood Sugar 107 at 1:43 pm. Client was wearing 2 face masks. She removed the mask and stated she feels better. States she was hungry. After EMS obtained 2 sets of vitals within normal limits, patient stated she felt better and was discharged home by EMS at 1:45 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/07/2021,02/07/2021,0.0,OTH,"Yes, BP meds.",none,"HTn, Cardiac",,"Pcn, Sulphur and shrimp","['Asthenia', 'Blood glucose increased', 'Dizziness']",1,PFIZER\BIONTECH,IM 1011013,PA,58.0,F,Developed shingles 6 days post second vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/06/2021,4.0,PVT,"Zinc 50mg Vitamin C 500mVit D 2,000mg Losartan 50mg Atorvastatin 10mg",None,Igg Subclass MGUS HTN,,Codeine Fluroquinalones Macrolides PCN Cephalosporins,['Herpes zoster'],UNK,MODERNA, 1011014,OH,45.0,F,"Monitor 9RN) checked on pt at 15 min check. Pt stated to RN that she was feeling warm, lightheaded and slightly dizzy. POD leader + supervisor was informed. Supervisor informed EMS staff of current situation. Pt was monitored for 15 min more at that time water was given + vitals were taken. BP 140/75, HR 105,SPO2 94% RA & 20 respirations. 09:15 Pt reassessed by (RN) & (EMS), pt showed no changes, and stated that she felt the same. Pt was removed to a private area to be further evaluated and await until squad arrived. Pt. also stated to staff that she typically experiences these symptoms whenever she takes in any form of nuts. Pt stated she does have an epipen injection. 0922 squad arrived. BP 148/90, HR 83, SPO2 99% RA, RR 20. Pt lung sounds were clear stated by EMS staff. Pt refused to be rescue by squad/ EMS but instead taken by her husband. Pt was informed that if anything went wrong on her way to TCH to call 911 right away. Pt agreed and was discharged at 0921AM.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,OTH,None,,,,Nuts,['Dizziness'],UNK,PFIZER\BIONTECH,IM 1011015,MN,39.0,F,"Injection site became warm to touch, raised/swollen and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/30/2021,02/06/2021,7.0,PVT,,,,,,"['Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 1011018,CA,,M,"amyotrophic lateral sclerosis/ severe pain/ full body-wide fasciculations; death; Information has been received regarding a case in litigation from a lawyer and referred to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 16-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route, lot# and expiration date were not reported). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered full body-wide fasciculations and amyotrophic lateral sclerosis. As a direct and proximate result of these injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 02-FEB-2019. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered serious and dangerous side effects, including death, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages. The cause of death was unknown. It was unknown if an autopsy was performed. The outcome of the event amyotrophic lateral sclerosis was considered as not recovered. The causality assessment between the events death and amyotrophic lateral sclerosis and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer. The lawyer considered the event amyotrophic lateral sclerosis to be disability. Upon internal review, amyotrophic lateral sclerosis was determined to be medically significant.",Yes,02/02/2019,Not Reported,Not Reported,,Yes,N,05/16/2014,02/02/2019,1723.0,UNK,,Prophylaxis; Routine health maintenance,,,,"['Amyotrophic lateral sclerosis', 'Death', 'Muscle contractions involuntary']",UNK,MERCK & CO. INC.,OT 1011025,PA,74.0,M,it severely aggravated my restless legs,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/04/2021,1.0,MIL,"creon,trazadone,metformin,b12,atorvasatin,magnesium,buspirone,vitd3,vitaminc,areds2,glipizide,babyaspirin,pramipexole,tamsulosin,ferroussulfaye,sertraline,empagliflozin",Diabetes and restless legs,"Diabetes, restless legs",,None,"['Condition aggravated', 'Restless legs syndrome']",UNK,PFIZER\BIONTECH, 1011026,OH,43.0,F,"Three min after vaccine, pt started feeling SOB racing heart. BP 148/100, HR 80, SPO2 100% RA, T:97 Six minutes after: dose, lethargic, sleepy, eyes dropped (look tired) & dizzy & c/o anxiety. Friend P/U to take her to ER. BP 144/92",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,01/30/2021,0.0,OTH,"HCTZ, amlodipine, VIt B, tumeric",none,HTN,,Seasonal,"['Anxiety', 'Blood pressure increased', 'Dizziness', 'Dyspnoea', 'Lethargy', 'Somnolence']",UNK,PFIZER\BIONTECH,IM 1011027,,42.0,M,"Initial onset at time listed- fever, severe myalgias, rigors, sweating, headache, anorexia, thirst, lethargy. Felt like severe flu. No pulmonary symptoms or GI symptoms. Symptoms improved with first ibuprofen dosing on 6Feb2021. Fever and myalgias recurred after Ibuprofen dosing subsided evening of 6 Feb2021. Full resolutions of symptoms on 8Feb2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/05/2021,1.0,MIL,Nexium,none,GERD,,none,"['Chills', 'Decreased appetite', 'Headache', 'Hyperhidrosis', 'Influenza like illness', 'Lethargy', 'Myalgia', 'Pyrexia', 'Thirst']",2,MODERNA,IM 1011028,NJ,58.0,M,Bell' Palsy . Right side facial weakness. Sudden onset ten days after vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,02/02/2021,10.0,UNK,None,None,"Diabetes, high blood pressure",,None,"['Facial paralysis', 'Facial paresis']",1,PFIZER\BIONTECH,SYR 1011029,OH,55.0,F,"1st vaccine, next day fever, severe headache, joint pain-severe. Lasting 2 days 2nd. vaccine, next day fever , achy and fatigue x 5 days. (fever lasting longer than expected) 5th day-diarrhea and fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/02/2021,1.0,WRK,Zoloft,No,None,,Codeine ASA,"['Arthralgia', 'Diarrhoea', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,MODERNA,IM 1011030,IN,40.0,F,"Fever, extreme headaches, stomach cramps, and nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,PVT,None,None,None,,None,"['Abdominal pain upper', 'Headache', 'Nausea', 'Pyrexia']",1,MODERNA,SYR 1011032,NJ,64.0,F,"Rigors, fever, body aches, headache, nausea and vomiting.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,WRK,None,None,High Blood Pressure. Seasonal allergies,,"lisinopril, pill form vitamin C","['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,MODERNA,IM 1011033,WA,37.0,F,Nausea/vomiting with movement of head-3 hours after shot; loss of balance with inability to walk; nausea/vomiting while sitting or attempting to stand-2 days; leg cramps/charlie horses- 3-5 days; general weakness in arms and legs- weeks/current; difficulty with fine motor movements in fingers and weakness in arms and hands-current,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,PVT,Metoprolol 50 mg Daily; Escitalopram 10mg; Claritin 5 mg,COVID19,HTN,,Zofran,"['Asthenia', 'Balance disorder', 'Fine motor skill dysfunction', 'Gait disturbance', 'Gait inability', 'Muscle spasms', 'Muscular weakness', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 1011034,PR,40.0,F,"CHILLS, FEVER 40 DEGREES CELSIUS, HEADACHE, ACUTE LEFT AXILLARY PAIN AND EDEMA, RIGHT AXILLARY PAIN, GREY COMPLEXION, MALAISE, GENERALIZED JOINT PAIN. DIFFICULTY RAISING UPPER EXTREMITIES DUE TO PAIN AN MUSCLE WEAKNESS,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,WRK,"TYLENOL, ADVIL, ASA, HCTZ, LOPRESSOR, COZAAR",,"HTN, ASTHMA",,PENICILLIN,"['Arthralgia', 'Axillary pain', 'Chills', 'Headache', 'Lymphadenitis', 'Malaise', 'Muscular weakness', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1011036,MD,23.0,F,Under my tongue hurt/ is very sore hurts to stretch tongue,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/04/2021,02/06/2021,2.0,UNK,,,Ulcerative Colitis,,,"['Glossodynia', 'Tongue movement disturbance']",2,PFIZER\BIONTECH, 1011038,NY,42.0,M,"Prior to vaccination, patient admitted to taking 25MG of benadryl PO. 3:30 PM: patient received his 2nd dose of the Pfizer COVID-19 vaccine. 3:48 PM: Onset of throat itching and tingling sensation of the right lower extremity. 3:48 PM vitals: BP 137/76, spO2 100%, HR 108, T 98.3F 3:48 PM: Benadryl 25MG IM was given in the left deltoid. 4:03 PM vitals: BP 116/67, spO2 98%, HR 95, T 98.4F. Patient said that he felt a headache that was 2/10 on the pain scale, reported less tingling in his his leg that was mostly felt in his R big toe, and felt some tingling left in his throat but says that ""it's nothing."" 4:50 PM: Patient's hands felt cold compared to his arms. Patient reported feeling cold in his arms and very tired. 4:55 PM: Patient was transported to the emergency department for further evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/05/2021,0.0,PVT,Fenofibrate Plavix Multivitamins,None,General anxiety disorder hypercholesterolemia,,None,"['Fatigue', 'Headache', 'Paraesthesia', 'Peripheral coldness', 'Pharyngeal paraesthesia', 'Throat irritation']",2,PFIZER\BIONTECH,IM 1011039,,35.0,F,began to feel chest and throat tightness. 25mg Benadryl and symptoms went away,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,WRK,,,,,,"['Chest discomfort', 'Throat tightness']",2,PFIZER\BIONTECH,IM 1011044,,51.0,F,"After vaccine given, lip tingling, then swelling, angioedema noticed, Benadryl & epi given, pt taken to emergency room. Patient observed in ED, vitals stabile and resolution of condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,PVT,,,,,,"['Angioedema', 'Lip swelling', 'Paraesthesia oral']",2,MODERNA,IM 1011050,NC,33.0,F,"Positive pregnancy test 1/10/21. EDD 9/18/21 based on LMP (12/12/21). Woke up extremely dizzy and could not get out of bed without almost falling over and very nauseated. Symptoms eventually subsided around 10:00 am. Did not have dizziness again. Had a confirmatory Ultrasound on 2/4/21 which measured 5weeks, 5 days and no yolk sac. Was supposed to be 7 weeks, 5 days. Determined that I miscarried.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/11/2021,3.0,WRK,"Prenatal vitamin, acetaminophen, B12, Vitamin D, VSL#3 Probiotic",None,"Celiac disease, acne",,"Benzoyl peroxide, gluten","['Abortion spontaneous', 'Dizziness', 'Exposure during pregnancy', 'Nausea', 'Ultrasound antenatal screen abnormal']",2,PFIZER\BIONTECH,IM 1011052,FL,74.0,M,"After client received vaccine he stated that he has tingling sensation around his mouth. Vital signs obtained by EMS BP 161/101, pulse 55, temp. 99.4. Client sent home by EMS. Second BP 162/82, Blood Sugar 125 at 4:20 pm. Client states he is feeling well (better).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/07/2021,02/07/2021,0.0,OTH,"Yes, on cholesterol meds","PCN, Heprin",High cholesterol,,,"['Blood glucose increased', 'Blood pressure increased', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 1011055,TX,62.0,F,"A day after the vaccine, a large baseball size knot appeared at vaccine site, later that evening it grew to softball size, hot, and very painful. When I got the first dose, was not as drastic as this second dose. After the first does, it lasted around 10 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/07/2021,1.0,PHM,"Lasarton, flecinine, Zyrtec, levothyroxin, levothyrine, gabapentin, methacarbomal, vitamin D, hctz, CBD capsule, singular, biotin.",None,"Kidney disease and Parkinson?s , chronic pain.",,"NSIDs, thimerasol","['Vaccination site mass', 'Vaccination site pain', 'Vaccination site warmth']",UNK,MODERNA, 1011059,,17.0,U,"No adverse effects. Pt was vaccinated 3 days prior to turning 18 years of age, which is the recommended age for administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/04/2021,02/04/2021,0.0,OTH,,,,,,['Product administered to patient of inappropriate age'],1,MODERNA,IM 1011060,GA,81.0,M,"Brain fog, agitation",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,SEN,"Fluticasone, Albuterol, zoloft, memantine, aricept, lipitor, Tylenol","Dementia, Depression, Thrombocytosis","Dementia, Depression, Thrombocytosis",,NKDA,"['Agitation', 'Mental impairment']",2,PFIZER\BIONTECH,IM 1011061,WV,19.0,M,"Bumps kind of like bug bites, that later make the skin dry and leathery. some are itchy and some just appear over night. the pop up locations are random.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/19/2021,5.0,PVT,none,none,none,,none,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 1011068,FL,73.0,M,Pfizer-BioNTech COVID-19 Vaccine EUA Bell's Palsy Face paralysis,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,02/03/2021,16.0,PVT,80 mg asprin; 40 mg simvastatin; 160/12/5mg valsartan/hydrochlorothiazide 1000mg turmeric;saw palmetto;centrum silver; 1000mg vit c; 2 capsules daily calcitrate/mag/zinc with vit d,sore throat,,Flu shot - more then 10 years ago,none,['Facial paralysis'],1,PFIZER\BIONTECH,IM 1011070,IN,42.0,M,Left fourth cranial nerve palsy and double vision.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/24/2020,3.0,UNK,Atorvastatin CoQ10 Omega-3 oral capsule,None,None,,Codeine,"['Cranial nerve paralysis', 'Diplopia', 'Magnetic resonance imaging brain']",UNK,PFIZER\BIONTECH, 1011075,MA,66.0,F,The patient consented to receive the vaccine at the facility on 1/31/21. She admitted to the facility on 1/29/21. She failed to inform us that she had already received her first vaccine at her rest home on 1/28/21. Consequently she received 2 doses of the Pfizer Covid-19 vaccine within 4 days. She had no adverse effects from either vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/31/2021,01/31/2021,0.0,SEN,,,"Bipolar Disorder, rheumatoid arthritis",,Bee stings,['Extra dose administered'],1,PFIZER\BIONTECH,IM 1011079,IA,18.0,F,"The patient was diagnosed with Mononucleosis on 2/1/2021. Symptoms started on 1/20/2021, 1 day after her second COVID vaccination dose. Liver enzymes were also elevated",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/20/2021,1.0,PVT,Loestrin 1.5/30 one tablet daily,None,Cystadenoma of ovaries,,NKDA,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood albumin decreased', 'Blood alkaline phosphatase increased', 'Infectious mononucleosis', 'Lymphocyte count increased', 'Neutrophil count decreased']",2,MODERNA,IM 1011084,PA,39.0,F,"Patient is a 39 y.o. female presenting to ED with itchy tongue and throat which occurred 1 hour after second dose of COVID-19 patient received vaccination this morning. Patient states symptoms started an hour and a half after vaccine administration. Patient denies rash or swelling. Patient received 50 mg of Benadryl for presentation. Patient will be discharged and instructed to follow up with primary care doctor in 1-2 days and return to the ED if symptoms worsen. Symptoms believed to be from allergic reaction, nausea. Pt received atarax, pepcid, zofran, decadron.. Patient will be discharged with atarax, epipen. Pt has no oral swelling on repeat exam.. Patient understands and agrees with plan.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,WRK,"Albuteral, Fioricet, Cymbalta, antivert, mobic, singular, phenergan, topamax, tramadol",none,"Back pain, neck pain, fibro, depression, anxiety, PTSD",,"iodine, iodine contrast, amoxicillin, clarithomycin","['Nausea', 'Throat irritation', 'Tongue pruritus']",2,PFIZER\BIONTECH,IM 1011087,GA,78.0,M,"Anxiety, Anger, Agitation, Pacing",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,SEN,"Synthroid, glucosamine, Insulin Glargine, glucosamine chondroitin, ASA, Trintellex, Prednisone, Remiron, Valium,","DM Type 2, Alzheimer's","DM Type 2, Alzheimer's",,NKDA,"['Agitation', 'Anger', 'Anxiety']",2,PFIZER\BIONTECH,IM 1011101,NC,66.0,M,"I have chronic Lyme disease, with extreme symptoms of photosensitivity and photophobia. 12 years ago, I had a series of intravenous antibiotics for 9 months. That halted the progression of the symptoms. However, with the first injection of the Pfizer vaccine, I had an immediate and increasing photosensitivity/photophobia. For example, my computer monitor was at 6% brightness. I reset to 3% brightness, which is still too bright. My concern is that the second injection due on February 12th may further increase the symptoms. My Lyme doctor believes that the light sensitivity is perhaps coming from the thalamus. Additionally, the injection seemed to increase my INR.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/22/2021,01/22/2021,0.0,PUB,"Antibiotics, anti-fungal, anti-microbial, zinc, vitamins C and D, Neurotin, Coumadin",None,"Chronic Lyme - symptoms: severe photosensitivity, severe photophobia",,"Shell fish,","['Condition aggravated', 'Photophobia', 'Photosensitivity reaction']",1,PFIZER\BIONTECH,IM 1011107,MI,48.0,F,"Patient was advised to sit for 15 minutes after the vaccination. The first time around patient did not have any allergic reaction to the vaccination. The patient was aware that there was still a potential of an reaction to the vaccination the second time. The patient sat in the same room vaccinations were being given after her vaccination. She felt a little stuffy so she asked if you could sit outside right by the door. When she went to sit outside in 2 minutes she started to cough and her airways became constricted along with her hands, face and tongue started to swell. Instantly we rushed to her with an Epi Pen but the patient had her own which she took out and used. We laid her on the floor putting a pillow beneath her head while raising her legs up in the air. The facility dialed 911 along with providing an oxygen mask. One minute after the Epi Pen the patient started to feel better then help arrived 5 minutes later to which she felt her airways constricting again. After the emergency help took her to the ER she came back in 3 hours and said she felt fine and the ER had released her.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/03/2021,0.0,SEN,Unknown,Unknown,Has preexisting medical conditions,,Many allergies such as food & latex.,"['Angioedema', 'Cough', 'Peripheral swelling', 'Swelling face', 'Swollen tongue']",2,MODERNA,IM 1011111,IN,46.0,M,"At 1700 01/10/2021, he began to feel numbness in his left lip, like he was given a numbing shot at the dentist. Over the next hour, it traveled superiorly up to his left cheek and to the inferior ear. He had a steroid and antihistamine sent in to the pharmacy and took this once he got home about 1930. Shortly thereafter, he started developing tongue numbness. He woke up in the middle of the night to use the restroom and reports he nearly fell into the bathroom wall due to the intensity of vertigo he was experiencing. The vertigo worsened throughout the day and he is very unsteady on his feet, requiring assistance and support from his wife to ambulate. He is unable to drive and reports exacerbation of dizziness when moving his head side to side. His wife reports he had a fever throughout the night 01/10/2021-01/11/2021. He feels the left eye is dryer and a bit weaker than usual and he has had to administer drops to help keep it moist.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/08/2021,01/09/2021,1.0,PVT,"ASA 81mg, Buproprion XL, Hydrochlorothiazide, Losartan, Liothyrinine, Synthroid, XHance",None,"Hypothyroidism, Pre-diabetes, Hypertension",,Lisinopril,"['Angiogram', 'Blood glucose increased', 'CSF glucose increased', 'Dizziness', 'Dry eye', 'Extraocular muscle paresis', 'Full blood count', 'Gait disturbance', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Impaired driving ability', 'Lumbar puncture', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging brain normal', 'Neutrophil count', 'Neutrophil count decreased', 'Pyrexia', 'Specialist consultation', 'Vertigo', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 1011114,KS,26.0,F,"Patient developed a rash around the injection site immediately following the injection 1/5/2021. Patient was given Benadryl 25 mg po 1/6/2021 @ 0729 am, and rash subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,No known Allergies,['Injection site rash'],1,MODERNA,IM 1011117,NC,79.0,F,Redness at injection site and warm to touch occurring 10 days post injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,02/05/2021,11.0,PVT,Levothyroxine 50mcg daily Meloxicam 7.5mg daily Omegan 3 1000mg 2 daily Citracal Aspirin 81 mg daily Multivitamin daily,None,Hypothyroidism Hyperlipidemia Osteoporosis,,Hydrocodone-Acetaminophen,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,IM 1011118,NJ,61.0,F,indigestion,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/08/2021,0.0,PVT,Lotensin 10mg po daily Aspirin 81mg po daily,unknown,unknown,,Shellfish derived and penicillin?s,['Dyspepsia'],1,PFIZER\BIONTECH,IM 1011129,KY,77.0,M,. Syncope and collapse 2. Respiratory arrest ADMITTED TO ICU,Not Reported,,Not Reported,Yes,,Not Reported,N,01/28/2021,02/07/2021,10.0,PVT,,,,,NKA,"['Circulatory collapse', 'Intensive care', 'Respiratory arrest', 'Syncope']",1,PFIZER\BIONTECH,IM 1011130,NH,96.0,F,Temp of 100.1 and unproductive cough on 1/17; temp of 100.4 1/28; O2 desaturation 88% on RA 1/28; Diagnosed with Covid-19 on 1/18/2021 Patient passed away on 1/29/2021,Yes,01/29/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/17/2021,10.0,SEN,Aricept Acetaminophen Citalopram Diltiazem Lisinopril Synthroid Vitamin D 3,NONE,Aricept Acetaminophen Citalopram Diltiazem Lisinopril Synthroid Vitamin D 3,,NKA,"['Blood calcium decreased', 'Blood chloride normal', 'Blood creatinine normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea normal', 'Body temperature increased', 'COVID-19', 'Carbon dioxide normal', 'Cough', 'Death', 'Differential white blood cell count normal', 'Fibrin D dimer increased', 'Full blood count', 'Haematocrit normal', 'Haemoglobin normal', 'Platelet count normal', 'Red blood cell count normal', 'SARS-CoV-2 test positive', 'White blood cell count decreased']",1,PFIZER\BIONTECH,IM 1011131,MI,49.0,F,"After receiving COVID injection patient tasted metal in mouth, and developed severe dry mouth. Gave water and observed for 40 minutes. Oxygen was 98-100% HR 70-78 BP 146-150/96-100s. Symptoms lasted around 1 hour. After arriving home BP was 110/78. Patient felt better. No hospitalization needed. Next day patient felt Body aches, Head ache, fever last 20 hours. Patient feels better today 2/8/2020 the only symptom left is fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/06/2021,0.0,PUB,Ditropan started 10 days ago,None,None per patient,,None,"['Dry mouth', 'Dysgeusia', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1011134,MN,65.0,M,significant increase in tremors warranting ER evaluation within approx. 12 hrs of vaccine administration,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/05/2021,1.0,OTH,colace,none,"CRF, stable; chronic neck pain with radiculopathy, cervical; renal carcinoma status post nephrectomy 2016",,"bee stings, NKDA",['Tremor'],1,MODERNA,IM 1011141,VA,43.0,F,"02:30 reported feeling flushed and hot--B/P 160/80 P-120 feeling tingling in mouth, tongue felt thick, no SOB, no tightness in chest-- Dr in to see and orders per protocol 0.3mg Epi given at 2:40pm 2:50pm reported feeing better P now 84 no resp issues, tong feeling better, still with tingling in mouth 3:20pm sent to ER for observation--B/P 145/70 P-102 report from ER---symptoms did return later and she received Benadryl/steroids/another epi and no further symptoms after that discharged from ER approx 10pm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,PVT,Ubrelvy Naproxen,none,migraines trigeminal neuralgia,,iodine shelfish,"['Hot flush', 'Paraesthesia oral', 'Tongue disorder']",2,MODERNA,IM 1011142,KY,53.0,F,That evening states difficulty breathing and heart racing- itchy bumps on legs that worsened through Saturday. Encouraged to call PCP to speak about incident and about 2nd dose.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/03/2021,0.0,PUB,,,,,,"['Dyspnoea', 'Palpitations', 'Urticaria']",1,MODERNA,IM 1011149,NY,77.0,M,Developed heart arrhythmia and was unable to be revived.,Yes,02/04/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,02/04/2021,13.0,OTH,"acetaminophen 325 mg tablet Take 2 tablet by mouth every four hours as needed for pain. aripiprazole 15 mg tablet TAKE 1 TABLET BY MOUTH EVERY EVENING. Aspirin Low Dose 81 mg tablet,delayed release Take 1 tablet by mouth once a day. atorvas",paronychia of right index finger,Borderline Intellectual Functioning.*Paranoid Schizophrenia.*Depression.*Anxiety.*Diabetes Type II.*Esophageal Reflux.*Hiatal Hernia.*Diverticulosis.*CAD.*COPD.*NSTEMI.*Constipation.*BPH.*Urethral Stricture.*Hearing Deficit.*Sleep Apnea- uses C-PAP.*Hypercholesteremia.*HX Pancytopenia.*CHF.*Right Eye Floaters.*Hyponatremia.*Vit D Deficiency.*Dysphagia-moderate.*Hypertension.*,,"PCN, ACE inhibitors, erythromycin, Tamsulosin, ranexa, sulfasalazine, lisinopril","['Arrhythmia', 'Death']",1,PFIZER\BIONTECH,IM 1011150,PR,57.0,F,"Ten minutes after the vaccine was administered the patient started with a persistent nonproductive cough, hoarseness, chest tightness, shortness of breath. Vital Signs BP 128/77: P=96: R=19: O2 sat=100% Oxygen was administered by nasal cannula, Solumedrol 125mg IV and nebulizer therapy with Atrovent 0.2 x 1. Was kept under observation and after one hour the patient had recovered. Per the patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/03/2021,0.0,PVT,Kepra 1000 mg bid Lamictal 100 mg AM / 150 mg PM Lozartan 100/12.5 mg daily Norvasc 5 mg daily Singulair 10 mg hs Allegra 10 mg daily Dulera pump Syntroid 112 mcg daily,,Hypertension Asthma Epilepsy Thyroid cancer (remission) Hypothyroidism,COVID19 (Pfizer-BioNTech),Penicillin,"['Chest discomfort', 'Cough', 'Dyspnoea', 'Wheezing']",2,PFIZER\BIONTECH,IM 1011151,TX,36.0,F,Patient reported feeling dizzy and unwell shortly after receiving vaccine. Patient went to the ER where here blood pressure was under control. She received steroids from the ER and was told to take Benadryl when she returned home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/06/2021,0.0,PHM,unknown,unknown,unknown,,NKDA,"['Dizziness', 'Malaise']",1,MODERNA,IM 1011159,CO,24.0,F,"Pt received dose #2 Moderna COVID vaccine 2/2/21 @ Vaccine Clinic. Initially had some arm soreness, headaches, and malaise. 2/3/21 starting having chest tightness worse with deep breaths and exertion. Has also had low-grade fevers. Has some coughing with deep inspiration. Some mild nasal congestion and chronic throat pain/irritation. Taking Tylenol 1000 mg two hours PTA. 2/4/21 @ 1849 presented to Urgent Care for workup. Mild bilateral anterior cervical lymphadenopathy. Per provider ""Symptoms are likely adverse effects from the COVID vaccine."" Discharged home without escalation of care. Entered for tracking.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/03/2021,1.0,PVT,,,,,Benzyl peroxide topical agent -- puffy eyes itching,"['Chest discomfort', 'Cough', 'Headache', 'Limb discomfort', 'Lymphadenopathy', 'Malaise', 'Nasal congestion', 'Oropharyngeal pain', 'Pyrexia', 'Throat irritation']",UNK,MODERNA, 1011161,MA,50.0,F,"CHILLS, BODY ACHES, Fever 103.0,H/A and nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/28/2021,1.0,PVT,,,,,,"['Chills', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,IM 1011198,NJ,17.0,M,"No Adverse event occurred, but patient in retrospective review of data was discovered to have incorrectly been given Moderna vaccine while under 18 year old as approved in the EUA. The manufacturer was contacted and they provided information about an ongoing clinical trial in patients 12-18 years old receiving the same (100mcg) 2 dose series of Moderna COVID-19 vaccine, however this age group is not currently approved. This is being reported as an error having occurred with the Moderna COVID-19 vaccine. Patient/Guardian will be contacted by a prescriber to inform the patient of the historical event and explain when a 2nd dose can be given.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/25/2021,0.0,PVT,,,,,,['Product administered to patient of inappropriate age'],1,MODERNA,IM 1011204,AL,57.0,F,complained of lips tingling; observed additional 15 minutes; still had some tingling in lips but no other reactions.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/07/2021,02/07/2021,0.0,PVT,,,,,,['Paraesthesia oral'],1,PFIZER\BIONTECH,IM 1011205,PR,72.0,F,GRANULES INFLAMMATION LEFT NIPPLE AFTER 2 WEEKS.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/23/2021,9.0,PVT,NONE,NONE,"RESPITORY CRONIC,CARDIOVASCULAR PACEMAKER",,NONE,['Mastitis'],1,PFIZER\BIONTECH,IM 1011210,PA,23.0,M,Patient reported feeling lightheaded and dizzy minutes after receiving vaccine. Some diaphoresis. No overt fainting. VS: BP 110/66; P82; RR 16; Pulse Ox: 98%,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,PUB,None,None,None,,None,"['Dizziness', 'Hyperhidrosis']",UNK,MODERNA,IM 1011214,,33.0,F,"After receiving covid vaccine, employee experienced palpitations, lightheadedness, and had a ""funny taste"" in her mouth. VS: BP 155/75, HR 97, spo2 98%. She hadn't eaten or drank anything and was given water and snacks. Repeat VS: BP 125/81, HR 82, s,po2 9",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/05/2021,02/05/2021,0.0,WRK,,,,,,"['Dizziness', 'Palpitations', 'Taste disorder']",2,MODERNA,IM 1011220,MA,49.0,F,"NAUSEA, CHILLS, BODY ACHES, FATIGUE, ?FEVER",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/27/2021,1.0,PVT,,,,,,"['Chills', 'Fatigue', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,IM 1011221,WV,71.0,F,"Patient diagnosed with Bells Palsy, mild case. Symptoms include numbness and pain on the left side of the patients face along the facial nerve. Patient also experienced left sided drooping of her cheek, lips and eye.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,02/01/2021,9.0,PVT,Elavil aspirin vitamin d colace flonase synthroid melatonin,,hypothyroidism,,,"['Facial paralysis', 'Hypoaesthesia']",1,PFIZER\BIONTECH,IM 1011222,PA,83.0,F,"My mom received the Covid 19 vaccine on Jan 5, 2021 and became very about a week later. I was informed that she tested positive for Covid 19 on January 14th. One January 17th she became very tired and weak and would not eat. Hospice called me and told me that she was in a decline state. I saw her on January 25 and 26 and she was just sleeping and could not open her eyes. Her vitals were good and she seemed to understand when I talked to her - she would squeeze my hand and moan but she could not talk or open her eyes. My mom passed away on January 27, 2021 just 22 days after receiving the Covid 19 vaccine. She was very think to begin with and being to weak and tired to eat resulted in her losing even more weight. Some of the other residents were given fluids to help and they recovered. My mom was not given fluids. I believe there were 20 deaths in her care home for the month of January when they vaccinated. This was an alarming number of deaths for the home. The facility had very few Covid deaths in 2019 and 2020. I asked every week if they had any Covid and or Covid deaths and this amount was shocking to me and the workers there.",Yes,01/27/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/17/2021,12.0,SEN,Medicine to keep blood pressure from dropping and medicine for AFIB (irregular heart),Dementia. Physical health was good. Hospice was thinking of releasing her because she was doing so well.,Dementia. I am told that 20 other residents passed in January after the vaccine was administered. A monthly death count very high for the care home.,,Allergies to grass and environment and a touch of asthma,"['Aphasia', 'Asthenia', 'Death', 'Diet refusal', 'Fatigue', 'Feeding disorder', 'General physical health deterioration', 'Moaning', 'Somnolence', 'Weight decreased']",UNK,PFIZER\BIONTECH, 1011223,AL,52.0,F,complained of dizziness; refused to stay to be observed extra 15 minutes; no other problems.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/07/2021,02/07/2021,0.0,PVT,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 1011233,TX,50.0,F,"COVID Arm, red, itchy, raised blotch about 2 inches in diameter around the injection site. lasted about 2-3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/19/2021,8.0,WRK,none,none,none,,PCN?,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 1011234,AK,66.0,F,"Approximately 2 hours after her first COVID-19 Vaccine dose, patient began to feel right arm numbness and tingling in her hand. This progressed to right leg numbness, tingling and weakness and right lower face tingling. Patient denied any facial droop, slurred speech, confusion or dizziness. Patient reports that symptoms peaked the night of the vaccine around 9 or 10pm and had gotten better but not totally resolved. She was advised to go to the ER and was admitted. MRI showed an acute infarct in the left basal ganglia. CTA showed ""short segment moderately severe narrowing of the M1 segment of the right MCA."" Neurologist was consulted and determined it to be coincidental that the patient had her COVID vaccine the same day.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/03/2021,02/03/2021,0.0,PVT,,,,,Neomycin,"['Cerebral infarction', 'Computerised tomogram head abnormal', 'Hypoaesthesia', 'Magnetic resonance imaging brain abnormal', 'Muscular weakness', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 1011239,MA,50.0,F,"TEMP 100.4 AFTER TYLENOL, FATIGUE, BODY ACHES, CHILLS, MILD H/A",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/26/2021,01/27/2021,1.0,PVT,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,MODERNA,IM 1011243,NC,81.0,M,"Reported to us: Patient was in and out of emergency room four days after vaccination. He was in a fog or catatonic state. He was on Cipro when 1st dose was administered. He had ""places frozen off his face the day before the vaccine.""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/25/2021,0.0,PVT,Taking Cipro,"""Had frozen places frozen off his face the day before the vaccine""",unknown,,,['Catatonia'],1,MODERNA,IM 1011248,AL,50.0,F,itching scalp; arms; patient took own benadryl; denies sob; no problems with throat; 17:15 feels better but still itchy; no respiratory issues; no other problems.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/07/2021,02/07/2021,0.0,PVT,,,,,,['Pruritus'],1,PFIZER\BIONTECH,IM 1011252,,29.0,M,"CHILLS, FEVER 100.2, BODY ACHES, H/A and nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/27/2021,01/28/2021,1.0,PVT,,,,,,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,IM 1011257,AL,46.0,F,had slight itching to arms; no trouble breathing; no other problems; observed additional 15 minutes;,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/07/2021,,PVT,,,,,,['Pruritus'],1,PFIZER\BIONTECH,IM 1011258,CO,52.0,F,"extreme fatigue, body aches and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/03/2021,0.0,WRK,"atenolol, estradiol, Zoloft, prilosec",,"depression, gastric bypass, rapid heart rate",,mushrooms,"['Fatigue', 'Headache', 'Pain']",1,MODERNA,IM 1011264,IL,54.0,F,next day fever and palpitations. Coming and going for days. on 2/4/2021 started having LLE and RLE numbness and tingling. Went to ED given hx of CVA. Testing all normal. Started to resolve 2 hours later. Continues to have pain at injection site (today is 2/8/2021),Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/27/2021,01/28/2021,1.0,OTH,"Vitamin D Vitamin C MVI aspirin 81 mg delayed release PO qday atorvastatin 80 mg PO qday clopidogrel 75 mg PO qday Paxil CR 37.5 mg extended release PO qday Xanax 0.5 mg tabs, Currently using daily prn - managed by psych",none,"s/p covid and covid pna 11/2020 (NOT chronic, sxs resolved) and depression/panic - per psych Atrial septal defect Q21.1 repaired PFO Elevated hemoglobin A1c R73.09 5.7 2/2020 Hearing loss(right ear) H91.91 History of stroke with residual deficit(s) I69.30 homonymous bilateral field defects, left side(left side) H53.462 L superior quadrantopia s/p CVA Hypothyroidism E03.8",,none,"['Blood test normal', 'Computerised tomogram head', 'Electrocardiogram normal', 'Full blood count', 'Hypoaesthesia', 'Injection site pain', 'Magnetic resonance imaging brain normal', 'Palpitations', 'Paraesthesia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1011265,PA,61.0,F,"intractable migraine, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,PVT,"zocor, propranolol, Aimovig, trazodone, Ubrelvy",none,"migraine, Vit D def, mixed hyperlipidemia, HTN, GERD",,"sumatriptan, iodine",['Fatigue'],2,MODERNA,IM 1011317,NC,83.0,F,"12 days after first vaccination: Dizziness; high blood pressure; nearly passed out; right arm numbness; inability to grip or pick up items with fingers; feeling of ""lopsidedness""; unsteady on feet, requiring assistance to walk. Primary care physician recommended ER visit where possible stroke was diagnosed. Hospital MRI confirmed: "" Left acute arterial ischemic stroke, MCA (Middle cerebral artery)"" . Spent 2 days in hospital with high blood pressure, dizziness. Residual right finger numbness upon release.",Not Reported,,Yes,Yes,2.0,Yes,N,01/25/2021,02/05/2021,11.0,OTH,Hydrochlorothyazide Escitalopram NP Thyroid Omega 3 Vitamin D Vitamin C w/Zinc Easy Iron,,Alzheimer's disease,,"Amlodipine, Ciprofloxacin, Tamoxifen, Levothyroxine, Losartan, Lisinopril, Keflex","['Blood test', 'Cerebrovascular accident', 'Computerised tomogram', 'Dizziness', 'Electrocardiogram', 'Feeling abnormal', 'Gait disturbance', 'Grip strength decreased', 'Hypertension', 'Hypoaesthesia', 'Ischaemic stroke', 'Magnetic resonance imaging abnormal', 'Mobility decreased', 'Ultrasound scan']",1,PFIZER\BIONTECH,IM 1011362,FL,72.0,M,"Patient's son came to the vaccine clinic today 2/8/2021, stated that his father 2/24/1948 passed away the same day as the vaccine.",Yes,01/28/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,PVT,,,COPD Diabetes,,,"['Autopsy', 'Death']",1,MODERNA,IM 1011372,MO,87.0,M,Massive Brain hemorrhage. Collapsed on 4 Feb 2021. Air medevac to Hospital. Life support removed on 07 Feb 2021,Not Reported,,Yes,Yes,4.0,Not Reported,N,01/29/2021,02/04/2021,6.0,OTH,Metropolol 25 mg Euthyroid 50 mcg Levothyroxin Amlodipine 2.5 mg twice Januvia 100 mg Metformin 500 mg. Twice Euthyrox. 50mcg,None,Diabetes Pacemaker about 10 years ago,,None,"['Cerebral haemorrhage', 'Laboratory test', 'Scan brain', 'Syncope', 'Withdrawal of life support']",1,PFIZER\BIONTECH,SYR 1011383,PR,41.0,F,"patient presents with ascending progressive weakness in legs and arms, 15 days after receiving the second dose of the COVID-19 vaccine Pfizer/BioNTech (R/O Guillian-Barre).",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/20/2021,02/03/2021,14.0,PVT,Ativan 1 mg tablet Ajovy 225 mg/1.5ml,Migraines,,,Unknown,"['Culture', 'Helicobacter test', 'Influenza A virus test', 'Influenza B virus test', 'Influenza virus test', 'Muscular weakness', 'SARS-CoV-2 test', 'Staphylococcus test']",2,PFIZER\BIONTECH,IM 1011384,AZ,37.0,F,"Pulmonary Embolism, hospitalized from 2/2/2021-2/3/2021. Received anti-coagulants and will remain on anti-coagulants for at least 3 months.",Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/27/2021,02/01/2021,5.0,SEN,,,,,,"['Anticoagulant therapy', 'Computerised tomogram', 'Fibrin D dimer increased', 'Pulmonary embolism', 'SARS-CoV-2 test negative']",UNK,MODERNA, 1011392,NJ,84.0,F,"Patient is a 84-year-old female presenting to the emergency room with anxiousness, generalized weakness and one episode of vomiting/nausea surrounding her Covid vaccination this afternoon. On exam patient appears mildly anxious, has no evidence of allergic reaction, lungs are clear and equal bilaterally. Patient is resting comfortably, speaking in complete sentences. Shortly after physical exam patient was noted to have oxygen saturation of 90 to 92%, subsequently placed on 2 L nasal cannula. Will obtain CBC, CMP, chest x-ray, EKG. We will also give patient 500 cc of fluid and 4 mg of Zofran for control of nausea and vomiting. We will continue to monitor patient. No leukocytosis, no AKI, electrolytes within normal limits, chest x-ray without evidence of underlying pneumonia or pneumothorax. I have reevaluated patient, patient has been reporting a ongoing headache for which she has a history of and takes Fioricet, requesting Fioricet. Will order Fioricet. We attempted to take patient off of her oxygen however when taken off the oxygen she drops to 88% on room air. Patient reports ongoing generalized weakness and nausea which has required an additional 4 mg Zofran. Given that patient has been monitored for couple of hours and has had ongoing nausea and vomiting, generalized weakness in the setting of hypoxia when taken off of oxygen will obtain troponins and admit patient to the hospital for obs. I have spoken to Dr. who has accepted patient to observation with telemetry for further management. Patient was informed of admission status, with no further questions at this time.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/05/2021,02/05/2021,0.0,PVT,,,headaches,,penicillin,"['Anxiety', 'Asthenia', 'Blood glucose increased', 'Blood urea increased', 'Chest X-ray normal', 'Electrocardiogram normal', 'Full blood count', 'Headache', 'Hypoxia', 'Laboratory test abnormal', 'Nausea', 'Oxygen saturation decreased', 'Oxygen therapy', 'Vomiting']",1,PFIZER\BIONTECH,IM 1011397,AL,68.0,F,"Head fullness, sinuses dried, nose stuffy, weak, spacey, rapid pulse, Felt as if I would pass out, ashy/pale complexion. Felt extremely weak in the evening.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/06/2021,0.0,OTH,"HCTZ, Lisinopril, Lipitor",none,athritis,,none,"['Asthenia', 'Dizziness', 'Feeling abnormal', 'Head discomfort', 'Heart rate increased', 'Nasal congestion', 'Pallor', 'Paranasal sinus hyposecretion', 'Sinus congestion']",1,PFIZER\BIONTECH,IM 1011398,MA,67.0,F,"TIA ~ found slumped in chair, aphasic, unable to stand. sent to local hospital emergency room",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/04/2021,02/05/2021,1.0,PUB,"Xarelto (for A fib), atorvastatin 40 mg, lipitor, fosamax, atenolol, calcium citrate.",,A-fib and Hypertension,,Sulfa drugs,"['Aphasia', 'Blood test', 'Chest X-ray', 'Computerised tomogram', 'Dysstasia', 'Full blood count', 'Magnetic resonance imaging', 'Mobility decreased', 'Spinal X-ray', 'Transient ischaemic attack', 'Ultrasound Doppler', 'X-ray']",2,MODERNA,IM 1011422,AZ,27.0,F,"I am 29 weeks pregnant with my first pregnancy and due April 22, 2021. I woke up and felt a tender lump on the right side of my torso. It is 4 inches down from my ribs. It feels soft and hurts to touch. I contacted my doctor and they said that if it continues to get worse then to come in and get it checked out but as of now - just wait and hopefully it will go down.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,OTH,Lexapro 10mg Prenatal,None,None,,No,"['Foetal exposure during pregnancy', 'Lymph node pain']",2,PFIZER\BIONTECH,SYR 1011440,NC,78.0,M,unanticipated death,Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/30/2021,4.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH, 1011453,,83.0,F,"SOB, Hypoxia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,,,,,,"['Dyspnoea', 'Hypoxia']",UNK,PFIZER\BIONTECH, 1011459,,72.0,M,"Sob, Hypoxia",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/27/2021,01/28/2021,1.0,UNK,,,,,,"['Dyspnoea', 'Hypoxia']",UNK,PFIZER\BIONTECH, 1011463,OH,75.0,M,"Pt presented to clinic stating he lost his keys. He proceeded to receive vaccination and was walked to observation area. No notable events during 15 minute observation. Approx 1.5 hours after observation pt was found in parking lot by sheriff trying to get into his car/calling his wife. Pt was brought inside, B/P was around 130/50 HR initially around 110, Oxygen around 92%, states had light headedness after getting vaccine, states no trouble breathing and feels fine. Was confused and unable to answer questions appropriately. Skin was slightly pale and cold. After approx an hour of observation oxygen dropped to high 80% and heart rate increased to 115+",Not Reported,,Not Reported,Yes,,Not Reported,N,02/08/2021,02/08/2021,0.0,PUB,"Per health screening reports ""aspirin 81mg everyday for years""",Denies,Type 2 diabetes,,Denies,"['Communication disorder', 'Confusional state', 'Dizziness', 'Heart rate increased', 'Oxygen saturation decreased', 'Pallor', 'Peripheral coldness']",1,MODERNA,IM 1011468,NJ,34.0,F,I had a reaction felt as if something was in my throat and chest tightness difficult to breath.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,"Jardin, Contrave/,Multi Vit, Vit E",No,"Pre Diabetic, Fatty Liver, Migraines.Asthma",,"Shellfish, Fish","['Blood test', 'Chest discomfort', 'Dyspnoea', 'Sensation of foreign body']",1,MODERNA,IM 1011487,CO,70.0,M,"Received Covid vaccine in am. Last seen by family at 17:30 pm and observed to be well. About an hour later he collapsed, unresponsive. A 911 call was initiated at 18:29. Paramedics arrived to find the patient in cardiac arrest. CPR/ACLS was initiated, but resuscitation was unsuccessful. Pt. was transported to MC where he was pronounced dead at 19:32. There was no sing of an injection site reaction, nor of allergic reaction..",Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/06/2021,0.0,PVT,"Tylenol, albuterol, Norvasc, Eliquis, Voltaren, Neurontin, lidocaine, Cozaar, Mevacor, Lopressor, Prilosec, Miralax, Senna, Renvela, Kayexolate, Incruse Ellipta, Vit. B complex, Coumadin",,"ESRD (dialysis fistula), peripheral vascular disease (R mid-foot amputation), cardiac disease (pace-maker), malnutrition (cachexic), possible liver disease (distended abdomen)",,Protein Supplement,"['Cardiac arrest', 'Death', 'Life support', 'Resuscitation', 'Syncope', 'Unresponsive to stimuli']",1,MODERNA,IM 1011492,NH,94.0,F,"1/18/2021- Tested positive for Covid-19. 1/20 Patient lethargic, unable to swallow. 1/24 Although 90% O2 sat on RA, it has decreased from her baseline ranging at high 90's. 1/27/2021 Patient passed.",Yes,01/27/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/27/2021,20.0,SEN,"Escitalopram Miralax Isosorbide Mononitrate Lactulose Melatonin Milk of Magnesium, Protnix, Acetaminophen, Senna-S, Zyprexa, Aspercreme lot",NONE,"CAD, Bradycardia, HTN, Hyperlipidemia, Protein Calorie Malnutrition, GERD, STEMI, Vitamin D deficiency",,Macrobid,"['Blood calcium normal', 'Blood chloride increased', 'Blood creatinine normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea increased', 'COVID-19', 'Death', 'Dysphagia', 'Full blood count', 'Haematocrit normal', 'Haemoglobin decreased', 'Lethargy', 'Metabolic function test', 'Oxygen saturation decreased', 'Platelet count normal', 'Polymerase chain reaction positive', 'Red blood cell count decreased', 'SARS-CoV-2 test positive', 'White blood cell count normal']",1,PFIZER\BIONTECH,IM 1011517,,83.0,F,"Patient reported left arm numbness. Went to the hospital for full stroke evaluation all tests returned negative. (CT scan, MRI, etc.). Patient was observed overnight and released from hospital with resolved symptoms and negative report of any stroke or mini-stroke. Patient has had follow-up appointments with PCP and Cardiologist. Received ok from PCP prior to second dose vaccination of COVID.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/07/2021,01/12/2021,5.0,PHM,,,,,,"['Cerebrovascular accident', 'Computerised tomogram normal', 'Hypoaesthesia', 'Magnetic resonance imaging normal']",1,MODERNA,IM 1011577,MN,93.0,M,"Resident expired on 2/5/21 at 03:35pm, about 25 hours after second dose of vaccine. At breakfast, resident was spitting a lot of secretions, coughing up liquids from nose and phlegm, facial swelling, which were all symptoms that he was struggling with prior to both doses of COVID vaccine, but had increased more than prior incidences on 2/5/21. Gurgling noted in upper airways, hyscolamine given, bath given to loosen secretions, morphine given. Family notified and came into facility for compassionate care visit around 1300. 1400 HR was 3 and RR was 2, but increased back to 60 and 12 within 20 minutes. Then resident expired at 1535.",Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,SEN,albuterol sulfate nebulization hyoscyamine sulfate atropine sulfate lorazepam concentrate morhpine sulfate metolazone lasix benadryl robitussin levothyroxine fluocinonide cream nystatin cream remeron spironolactone tylenol extra strength tr,"Was started on hospice between first dose of vaccine (1/7/21) and second dose (2/4/21), primarily for inability to control fluid balance due to heart failure and kidney failure. Started to have increased edema and respiratory symptoms (nasal drainage, raspy voice but denied sore throat) and tested negative for COVID twice starting 1/5/21 and 1/7/21 (day of first vaccine), and once again after the vaccine, increased confusion at that time and continued between vaccination. Later the nasal drainage was attributed to fluid overload. UTI on 1/11/21. Hospice referral by MD on 1/15/21.","History of type 2 diabetes, benign prostatic hyperplasia, heart failure, hypertension, constipation, vitamin D deficiency, hypothyroidism, chronic kidney disease stage 3, insomnia, tinea corporis, macular degeneration, polyosteoarthritis, UTIs. Short term memory difficulties. Resided in LTCF for 3 years prior to death.",,no known allergies,"['Cough', 'Death', 'Increased bronchial secretion', 'Productive cough', 'Rhinorrhoea', 'Secretion discharge', 'Swelling face']",2,MODERNA,IM 1011595,CA,90.0,M,"On 2/5/2021 resident noted to be azotemic. Creatinine up to 3.8 and BUN in 80's. He was started on NS hydration. On 2/7/2021 he was noted without VS, per MD notes, possible VF arrest, renal failure; death unclear exact cause.",Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/03/2021,6.0,SEN,"Glimepiride Tablet 1 MG,hydrALAZINE HCl Tablet 10 MG,Pantoprazole Sodium Tablet Delayed Release 40 MG,Meclizine HCl Tablet,Isosorbide Mononitrate ER Tablet Extended Release 24 Hour 30 MG,Senna Tablet 8.6 MG (Sennosides),Furosemide Tablet 20","ACUTE RESPIRATORY FAILURE WITH HYPOXIA, COPD, CHF, HTN, ANEMIA IN CHRONIC KIDNEY DISEASE, TYPE 2 DIABETES MELLITUS WITH DIABETIC NEPHROPATHY, GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS, HYPERLIPIDEMIA, UNSPECIFIED, DEMENTIA, AFIB, CKD STAGE 4, BENIGN PROSTATIC HYPERPLASIA WITHOUT LOWER URINARY TRACT SYMPTOMS, UNSPECIFIED ASTHMA, UNCOMPLICATED, HYPERPARATHYROIDISM, UNSPECIFIED",,,NKA,"['Azotaemia', 'Blood creatinine increased', 'Blood urea increased', 'Brain natriuretic peptide', 'Cardiac arrest', 'Death', 'Full blood count', 'Metabolic function test', 'Renal failure', 'Ventricular fibrillation', 'Vital signs measurement']",2,PFIZER\BIONTECH,IM 1011631,NJ,39.0,F,Moderna COVID-19 Vaccine EUA: Vaccine recipient reported 2/6/2021 that she received 1st dose of Moderna on 12/29/2020. Within 24 hours she developed a fever (T max 102) and body aches. She reported that the fever would not break. On 1/1/2021 she went to the ED and was prescribed azithromycin for left lower lobe pneumonia. COVID-19 test was negative on 1/1/21. On 1/6/2021 she went back to the ED for worsening symptoms and was subsequently admitted. Her COVID tests were negative. From 1/6/2021 to 1/11/2021 she was hospitalized at Medical Center for pneumonia. She was ordered antibiotics and steroids. Her COVID-19 test was negative on 1/11/2021. She was discharged on 1/11/21 to home.,Not Reported,,Not Reported,Yes,5.0,Not Reported,N,12/29/2020,12/30/2020,1.0,WRK,,,,,"Sulfa, Latex","['Pain', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 1011677,NH,101.0,F,"Lethargic, refusing medications and meals. 1/11/2021- Covid+, poor appetite.",Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/11/2021,4.0,SEN,Acetaminophen Tablet Exelon Patch Lisinopril Tablet Metoprolol Tartrate Tablet Protonix,01/16/2021 Pt had bried unresponsive episode,"Alzheimer's disease, Hx of TIA, Vitamin D deficiency, HTN, Syncope and collapse, Hyperlipidemia.",,NKA,"['Blood albumin decreased', 'Blood creatinine increased', 'Blood thyroid stimulating hormone normal', 'Blood urea increased', 'COVID-19', 'Decreased appetite', 'Food refusal', 'Glomerular filtration rate decreased', 'Haematocrit decreased', 'Haemoglobin increased', 'Lethargy', 'Platelet count normal', 'Red blood cell count decreased', 'Refusal of treatment by patient', 'SARS-CoV-2 test positive', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1011689,FL,66.0,F,"First Vaccine - produced fever, chills, headache, dizziness, nausea - lasted 2 days - Vaccine was administered Sunday at 3:20 PM and I was sick Monday and all day Tuesday - by Wednesday I was fine Second vaccine was January 31st at 3 PM - the next morning I woke up - got in the shower - got nauseous dizzy and fell breaking my left leg and left ankle. I still had nausea for 6 days and headache for 6 days - seems better today",Not Reported,,Not Reported,Not Reported,,Yes,U,01/10/2021,01/11/2021,1.0,PVT,Phenobarbitol Vitamin D Vitamin B Multi Vitamin Fish Oil Areds (eye vitamin) Zinc,None,Epilepsy - only one seizure over 50 years ago -,,Penicillin,"['Ankle fracture', 'Cast application', 'Chills', 'Dizziness', 'Fall', 'Headache', 'Lower limb fracture', 'Nausea', 'Pyrexia', 'X-ray']",2,PFIZER\BIONTECH,IM 1011707,IL,31.0,F,"Bloody mucus when blowing nose, petechia on legs 1/29/21.",Not Reported,,Yes,Yes,5.0,Not Reported,Y,01/26/2021,01/28/2021,2.0,PVT,"Prenatal vitamin, Mucinex D, and Vit, D",,"Thrombocytopenia, unspecified",,Spironolactone ITCHING Rituximab,"['Activated partial thromboplastin time', 'Blood fibrinogen', 'Blood magnesium', 'Epistaxis', 'Full blood count', 'International normalised ratio', 'Metabolic function test', 'Petechiae', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,IM 1011732,,80.0,M,patient passed away with in 60 days of receiving COVID vaccine series,Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,,01/30/2021,02/03/2021,4.0,SEN,,,,,,['Death'],2,MODERNA, 1011774,GA,81.0,M,"Cardiac arrest resulting in death on the third day post vaccine administration, 0224. Reported syncopal event post toileting. Rescue measures attempted but not successful. Time of death 0358, 02/06/2021.",Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/06/2021,3.0,OTH,ASPRIN CLOPIDOGREL LISINOPRIL NITROQUICK FINASTERIDE AMLODPINIE PRAVASTATIN TAMSULOSIN,"CAROTID ARTERY STENOSIS CORONARY ARTERY DISEASE PACEMAKER CABG, 4-VESSEL BPH",SAME AS ABOVE,,NONE KNOWN,"['Cardiac arrest', 'Death', 'Resuscitation', 'Syncope']",1,MODERNA,SC 1011820,OR,75.0,M,"This gentleman was hospitalized with dyspnea, found to have a leukocytosis and probable right lower lobe pneumonia, hospitalized for IV antibiotic therapy. He is still hospitalized but improving as of the date of this report. His COVID-19 test was negative on the day of admission. He had no symptoms out of the ordinary on the day of his vaccination. I am reporting this as it occurred in the week after his first dose of vaccine though would suspect the timing is likely coincidental rather than directly related to the vaccine.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/31/2021,02/04/2021,4.0,PVT,"Tylenol, Aspirin, Atorvastatin, Carvedilol, Vitamin D, Clopidogrel, Cyanocobalmin, Folic acid, Insulin (glargine and aspart), liraglutide, mangesium oxide, methotrexate, morphine ER, ondansetron, oxycodone, pantoprazole, ropinirole, senna,",No acute illnesses at the time of vaccination or in the prior month,"Rheumatoid Arthritis, Type 2 diabetes, Obesity hypoventilation syndrome, Obstructive sleep apnea, Congestive heart failure, chronic respiratory failure due to aforementioned conditions, Severe obesity (BMI 37), CKD stage 3, Peripheral arterial disease, BPH, Coronary artery disease with history of CABG, lymphedema, chronic wounds/pressure injuries of up to stage 2 depth on lower extremities, GERD",,"Infliximab (anaphylaxis), Lisinopril (cough), Erythromycin (shaking, nervousness)","['Atelectasis', 'Chest X-ray abnormal', 'Dyspnoea', 'Leukocytosis', 'Pneumonia', 'SARS-CoV-2 test negative', 'White blood cell count increased']",1,MODERNA,IM 1011834,,62.0,M,patient passed away within 60 days of receiving COVID vaccine series,Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,,01/27/2021,02/06/2021,10.0,SEN,,,,,,['Death'],2,MODERNA, 1011837,IN,78.0,M,"Pt received his first Moderna injection on 2/6/21. On 2/7/21 he developed chills and fever in the afternoon. Pt woke up on 2/8/21 and had pronounced weakness. Nursing Home/Assisted living reports falls x 2 this am. First at 4 am and the second at 6 am. Pt normally is ambulatory and still capable of driving a car. Reports today generalized weakness. He is having difficulty walking and lifting his extremities. He also is having difficulty lifting his head off the pillow. He reports generalized body aches and lower back pain. He presents to the ER with a rectal temp 100 degrees. His vital signs are normal otherwise. He had a septic work-up in the ER that included labs, urinalysis and imaging. Only abnormal lab was a elevated lactic acid. Pt received IV fluids and was admitted to the hospital for further monitoring. He is routinely tested for COVID in the NH. Last time was Friday 2/5 21 and was negative. The patient had rapid COVID testing repeated in the ER again the results were not detected. He has no swallowing issues and he is able to move extremities but again demonstrates pronounced weakness.",Not Reported,,Not Reported,Yes,,Yes,N,02/06/2021,02/07/2021,1.0,SEN,"Amitriptyline, Amlodipine, ASA, Hydrochlorothiazide, Janumet, Lisinopril, Lorazepam, Memantine, Metoprolol Suc ER, Omeprazole, Potassium Chloride, Probiotic, Multivitamin, stool softner, Miralax, Acetaminophen","Anxiety, CAD, Constipation, Diabetes, Diabetic neuropathic arthropathy, , hyperlipidemia, Hypertension, Insomnia","Anxiety, CAD, constipation, Diabetes, Diabetic neuropathic arthropathy, hyperlipidemia, HTN, Insomnia",,No known allergies,"['Asthenia', 'Back pain', 'Blood culture', 'Blood lactic acid', 'Body temperature increased', 'Chest X-ray', 'Chills', 'Fall', 'Full blood count', 'Gait disturbance', 'Glycosylated haemoglobin', 'Metabolic function test normal', 'Mobility decreased', 'Muscular weakness', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Urine analysis']",1,MODERNA,IM 1011860,MI,81.0,M,Two weeks later post vaccine developed full body Rash,Not Reported,,Not Reported,Yes,,Not Reported,U,01/11/2021,01/22/2021,11.0,PHM,"Losartan , metformin , norvasc,",,,,None,['Rash'],1,MODERNA,IM 1011883,FL,34.0,M,"I had a fever, headache for two days following the vaccine. Two days after I had chest pain and went to the emergency room. I was admitted with elevated troponin and diagnosed with myopericarditis.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/21/2021,01/25/2021,4.0,PVT,Cannabidiol,None.,"Previous myopericarditis 5 years prior, pericarditis 7 years prior.",,None.,"['Blood test', 'Chest X-ray', 'Chest pain', 'Condition aggravated', 'Echocardiogram', 'Headache', 'Myocarditis', 'Pyrexia', 'Troponin increased']",2,PFIZER\BIONTECH,IM 1011894,,70.0,M,patient passed away within 60 days of receiving COVID vaccine,Yes,02/04/2021,Not Reported,Not Reported,,Not Reported,,12/29/2020,02/04/2021,37.0,SEN,,,,,,['Death'],UNK,MODERNA, 1011905,NH,91.0,F,Ongoing decline overall. Remained on Hospice with increased lethargy documented on 1/20/21 and progressively worsening thereafter.,Yes,02/02/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/20/2021,12.0,SEN,"Refused medications on day of vaccine. Aspirin Tablet 81 MG(Last dose 1/6 8am), Docusate Sodium Tablet 100 MG(Last dose 1/6 8am), FLUoxetine HCl Capsule 20 MG(Last dose 8am), Lisinopril Tablet 10 MG(Last dose 1/6 8am), Melatonin Tablet 3 MG","Recent overall decline with generalized weakness, refusal of meals and medications, weight loss, and frequent falls. 1/5 Overall decline reviewed with APRN and ADPOA updated. 1/6-CBC WNL, BUN/Cr 55/1.93, GFR 24. Admitted to Hospice Services on 1/6. Covid Antigen Test negative on Jan 4th, 5th, 6th, 7th, 8th, & 9th. Covid positive on 1/10.","Dementia , Expressive aphasia, right-sided neglect and right sided weakness, high fall risk. S/P CEREBRAL INFARCTION DUE TO THROMBOSIS CORONARY ARTERY ANEURYSM ESSENTIAL (PRIMARY) HYPERTENSION PAROXYSMAL ATRIAL FIBRILLATION ABNORMAL RESULTS OF KIDNEY FUNCTION STUDIES CEREBRAL ANEURYSM, NONRUPTURED",,NKA,"['COVID-19', 'Condition aggravated', 'General physical health deterioration', 'Lethargy', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1011929,PA,85.0,F,"Within a few days, my mother started reporting profound fatigue and shortness of breath while conducting routine household activities. She no longer had to energy for her daily exercise walks and became increasingly lethargic. She died in her sleep while taking an afternoon nap on Thursday, February 4th. I am highly concerned this could be a vaccine related.",Yes,02/04/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/27/2021,6.0,PHM,none,none,hypercholesterolemia,,none,"['Asthenia', 'Death', 'Dyspnoea', 'Dyspnoea exertional', 'Fatigue', 'Lethargy']",UNK,MODERNA,SYR 1011934,TX,75.0,M,"Began to feel numbness, lack of sensation and loss of strength to the left limb from the waist down. Also noted weaker grip strength to the left hand. Loss of bladder and bowel control. This persisted throughout 2/5. On saturday 2/6 the right leg began to feel weak and numb as well although not as severe as the left limb. He was admitted to the hospital on Saturday evening, 2-6",Not Reported,,Not Reported,Yes,5.0,Yes,N,02/04/2021,02/05/2021,1.0,PVT,Simvastatin 20mg daily,none,none.,,none,"['Anal incontinence', 'Asthenia', 'Computerised tomogram head normal', 'Grip strength decreased', 'Hypoaesthesia', 'Laboratory test', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging spinal normal', 'Muscular weakness', 'Scan with contrast normal', 'Sensory loss', 'Urinary incontinence']",2,PFIZER\BIONTECH,IM 1011935,TX,81.0,M,"Patient received his second dose of Moderna COVID vaccine on 2/6 at 12:40PM. Patient was observed for 15 minutes post-vaccination with no adverse events. On the evening of 2/6 (time unknown) the patient began to develop dry cough and fatigue. He was checked by a physician at that time (who was a family member). Patient continued to feel unwell into Sunday. His lungs were clear when checked Sunday afternoon (time unknown). At approximately 5:30pm on 2/7 the patient began experiencing sudden onset shortness of breath. A pulse ox was conducted at that time and it was 92%, and again shortly thereafter and it was 90% (as reported by family member). 9-1-1 was contacted at this time. CPR was initiated when he arrived at the emergency department, pulse ox was 60% (as reported by family member). The patient passed away shortly thereafter on 2/8/2021.",Yes,02/08/2021,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/06/2021,0.0,OTH,Unknown,Unknown,Unknown,,No known drug/food allergies,"['Cough', 'Death', 'Dyspnoea', 'Fatigue', 'Malaise', 'Oxygen saturation decreased', 'Resuscitation']",2,MODERNA,IM 1011967,MT,40.0,M,"3:15 - Pt was leaning against wall c/o being dizzy and going to pass out - Pt was moved to reclining position - BP 144/100, RR 44, HR 120 - No itching ect. - Respirations rapid - O2 62 - Cannula applied - Pt continued c/o thinking he would pass out - Color pink - 3:15 1 cc Benedryl administered in R arm - 3:27 Epi 1 dose (0.7 cc) administered in R thigh - 3:30 EMS arrived - 3:34 EMS transferred pt to Medical Center",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/05/2021,02/05/2021,0.0,PUB,Zoloft for reflux,1/15/2021: swollen lymph nodes,,"1/8/2021, Moderna COVID-19 Vaccine, IM",NKA,"['Catheter placement', 'Dizziness', 'Posture abnormal', 'Respiratory rate increased', 'Skin discolouration']",2,MODERNA,IM 1011981,FL,21.0,M,Suicide,Yes,11/13/2020,Not Reported,Not Reported,,Not Reported,N,11/13/2020,11/13/2020,0.0,SCH,,,"ADHD, Anxiety, Depression",,,['Completed suicide'],1,SANOFI PASTEUR,IM 1012006,WA,,M,"He received the Prevnar 13 vaccination and developed another hyperinflammatory episode; complicated by steroid responsive pericardial effusion and presumed inflammatory pneumonitis; complicated by steroid responsive pericardial effusion and presumed inflammatory pneumonitis; This is a literature report. A contactable other healthcare professional reported that an approximately 7-year-old boy developed an episode of hyperinflammatory flare following vaccination with pneumococcal-13-valent-CRM197-vaccine-conjugate. Additionally, he exhibited lack of efficacy during treatment with azathioprine and methotrexate for chronic pulmonary disease and hyperinflammatory flares [dosages and routes not stated]. The boy was admitted at the age of 10 years for diagnostic lung biopsy in the setting of progressive chronic hypoxic respiratory failure and recurrent hyperinflammatory episodes. He had history of multiple hospital admissions due to infection-triggered recurrent hyperinflammatory flares. At the age of 4 months, he was admitted, for respiratory syncytial virus (RSV) infection. He was again admitted at the age of 1 year for hypospadias repair, and at the age of 3 years and 4 months he was hospitalised for another RSV infection. At the age of 3 years and 8 months he was admitted for what was thought to be mononucleosis due to Epstein-Barr virus positive IgM. Mild gross motor developmental delay was also noted. Till the age of 3 years he received regular vaccination. Subsequently, he stopped receiving vaccine. Approximately, at the age of 4 years, he was admitted with viral bronchiolitis. Respiratory symptoms slowly resolved and haematologic findings improved, thus representing a hyperinflammatory flare that recurred regularly over the following 6 years ranging from 4 to 17 weeks duration mainly treated with unspecified steroids. During the next flare he exhibited with anaemia, leucocytosis and thrombocytosis along with abdominal pain, hepatomegaly, and fevers. Infarcted spleen was also noted. This flare was associated with human herpes virus 7 viraemia. He was readmitted to hospital multiple times for such episodes. During two separate hospitalisations for flares, the diagnosis of haemophagocytic lymphohistiocytosis (HLH) and macrophage activation syndrome (MAS) were both considered based upon his laboratory features. Overall, two bone marrow biopsies were performed approximately 1 year apart, and both demonstrated normal cellularity and markedly increased hemophagocytosis. Subsequently, he received pneumococcal-13-valent-CRM197- vaccine-conjugate [prevnar-13] vaccine, and developed an episode of hyperinflammatory flare [duration of treatment to reaction onset not stated] which lasted for 4 months. It was complicated by prednisone responsive pericardial effusion and presumed inflammatory pneumonitis. He became corticosteroid dependent weaning of which resulted into haemolysis and dark urine. By the age of 8 years, his episodes were characterized less by persistent febrile episodes but more by shortness of breath, chest discomfort and intermittent desaturations. His condition was steroid responsive and therefore he was treated with prednisone. Subsequently, he started receiving steroid sparing therapy with methotrexate and azathioprine for hyperinflammatory flares and chronic pulmonary disease (later diagnosed as interstitial lung disease). The boy stopped receiving methotrexate and azathioprine. Later, due to his progressive respiratory symptoms, he was admitted to the hospital at the age of 10 years for lung biopsy. After lung biopsy, his condition worsened with right haemothorax and pneumothorax along with respiratory distress. For treatment of his inflammatory state corticosteroid dose was increased and gradually weaned, while anakinra and ciclosporin [cyclosporine] were trialed followed by tocilizumab, with minimal benefit. He died prior to his 11th birthday due to respiratory failure. Whole exome sequencing revealed compound heterozygous paternal frame shift a HMOX1 c.264_269delCTGG (p.L89Sfs*24) and maternal splice donor HMOX1 (c.636 + 2 T > A) consistent with HMOX1 deficiency. Finally he was diagnosed with HMOX1 deficiency that had recurrent autoinflammatory episodes marked by fever, hemolysis and hyperferritinaemia with pathologic features similar to MAS and HLH. Author Comment ""He received the Prevnar 13 vaccination and developed another hyperinflammatory episode lasting 4 months complicated by steroid responsive pericardial effusion and presumed inflammatory pneumonitis."" ""Steroid sparing therapies, such as methotrexate and azathioprine, were briefly introduced but discontinued because no benefit was observed."" The outcome of the events was unknown. It was unknown whether an autopsy was performed.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.; Reported Cause(s) of Death: respiratory failure",Not Reported,,Yes,Not Reported,,Not Reported,U,,,,UNK,,,"Medical History/Concurrent Conditions: Abdominal pain; Anaemia; Bronchiolitis (age of 4 years, he was admitted, Respiratory symptoms slowly resolved/haematologic findings improved); Epstein-Barr virus IgM antibody positive (At the age of 3 years and 8 months he was admitted); Fever; Gross motor delay (Mild); Haemophagocytic lymphohistiocytosis (based upon his laboratory features); Hepatomegaly; Hospitalization (due to infection-triggered recurrent hyperinflammatory flares); Hypospadias repair (admitted at the age of 1 year); Inflammation (hyperinflammatory flare that recurred regularly over the following 6 years); Leucocytopenia; Macrophage activation syndrome (based upon his laboratory features); Mononucleosis (due to Epstein-Barr virus positive IgM); Respiratory syncytial virus infection (At the age of 4 months, he was admitted); Respiratory syncytial virus infection (at the age of 3 years and 4 months he was hospitalised); Splenic infarction; Thrombocytosis; Viraemia",,,"['Biopsy lung abnormal', 'Chest discomfort', 'Chromaturia', 'Chronic respiratory disease', 'Condition aggravated', 'Cytogenetic analysis abnormal', 'Death', 'Dyspnoea', 'Gene mutation', 'Haemolysis', 'Haemothorax', 'Hyperferritinaemia', 'Inflammation', 'Interstitial lung disease', 'Oxygen saturation decreased', 'Pericardial effusion', 'Pneumonitis', 'Pneumothorax', 'Pyrexia', 'Respiratory distress', 'Respiratory failure']",UNK,PFIZER\WYETH, 1012020,AZ,38.0,M,"12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache. The worst occurred the day after when my body could no longer absorb insulin. I increased my basal rate by almost 400% and could not bring my sugars down. Saturday afternoon I began experiencing symptoms of diabetic ketoacidosis: stomach pain, vomiting, high ketones and very high blood sugars. I was able to eventually take in enough water to lower my ketones and sugar and narrowly avoided going to the ER, but high blood sugars and headache have persisted and I am still experiencing these symptoms.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,PUB,Humalog and Celexa,,Type 1 Diabetes,,,"['Abdominal pain upper', 'Blood glucose increased', 'Blood ketone body increased', 'Chills', 'Condition aggravated', 'Diabetic ketoacidosis', 'Headache', 'Insulin resistance', 'Ketosis', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 1012021,NH,93.0,F,"Resident on Hospice. 1/18 Hand Shaky. 1/19- Covid +19. 1/20 Desat 85% on RA, provided 2L O2 supplement= 97% 1/20 congestive cough, 1/28- RR-28;1/29- Hypoglycemia 1/30-NPO. 1/30-resident passed away.",Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/19/2021,12.0,SEN,Tenormin Tylenol Extra Strength,None,"CAD, Anemia, CKD Stage 3, Type 2 DM, HTN, Hyperlipidemia",,Codeine,"['COVID-19', 'Cough', 'Death', 'Hypoglycaemia', 'Respiratory tract congestion', 'SARS-CoV-2 test positive', 'Tremor']",1,PFIZER\BIONTECH,IM 1012035,MA,75.0,M,"Patient admit post dialysis with fever to 101, hypotension requiring pressors. Full infectious workup negative and he recovered within 24 hours.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/02/2021,02/03/2021,1.0,SEN,"MICONAZOLE POWDER,TOP MODERATE AMOUNT TOP TWICE A DAY groin rash Also adding to right axilla D. COMPLETE ACTIVE MEDICATION LIST: BENZONATATE CAP,ORAL 100MG BY MOUTH THREE TIMES A DAY AS NEEDED for cough COLLAGEN","PMH ESRD on HD MWF, HFrEF (EF 35%), COPD on 3 L oxygen, ? pulm htn, DM2, ? dementia, HLD, HTN, orthostatic hypotension, a fib on eloquis and metoprolol, DJD s/p b/l knee replacements, gout, +COVID in March 2020",,,doxycycline,"['Blood culture negative', 'Culture urine negative', 'Dialysis', 'Hypotension', 'Pyrexia']",UNK,MODERNA, 1012046,MA,35.0,F,About 4am after the vaccination I woke up with a terrible headache took tylenol and was in bed the remainder of the day d/t extreme fatigue. About 6pm I was able to get up and move around and felt a little better and all symptoms begin to subside within about 24 hrs. 7/29/2021-Expected delivery date,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/13/2021,1.0,PVT,"Prenatal, 20mg. Prilosec, 81mg Aspirin",no,PCOS,,no,"['Fatigue', 'Foetal exposure during pregnancy', 'Headache']",2,PFIZER\BIONTECH,IM 1012047,MO,57.0,F,Sudden death 2/7/21 @ 0309 Started acute encephalopathy & required intubation Soon after intubation went into cardiac arrest Likely severe acidosis.,Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/06/2021,5.0,SEN,Amlodipine Besylate; Antacid Suspension; Atorvastatin Calcium; Atropine Sulfate; Clozaril; Cyanocobalamin; metformin HCl; Metoprolol Tartrate; Tylenol,DMII,"Tobacco use, Schizophrenia, DMII, Bipolar, HTN, COVID 19 hx,",,NKA,"['Acidosis', 'Cardiac arrest', 'Encephalopathy', 'Endotracheal intubation', 'Sudden death']",2,MODERNA,IM 1012051,,77.0,M,"Leukocytosis with blast cells - concern for heme malignancy Jaw swelling with lymphadenopathy, confirmed with CT - ?2/2 to new heme malignancy vs adverse reaction to vaccine",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/03/2021,02/03/2021,0.0,UNK,Dupixent,,CAD s/p LAD stent,,"Almonds, possibly gluten","['Biopsy bone marrow', 'Biopsy skin', 'Blast cells present', 'Computerised tomogram abnormal', 'Cytogenetic analysis', 'Haematological malignancy', 'Leukocytosis', 'Lymphadenopathy', 'Skin test', 'Swelling face', 'Vaccination complication']",1,MODERNA,IM 1012365,,,F,"Hives; swelling; A spontaneous report was received from a pharmacist concerning a female patient participating who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the serious event of swelling and hives. The patient's medical history, as provided by the reporter, included an ""extensive history of allergies"" and history of taking diphenhydramine prior to influenza vaccination. No relevant concomitant medications were reported. On 27 Dec 2020, approximately 7 minutes prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 27 Dec 2020, the patient was admitted to the hospital with swelling and hives occurring 7 minutes after the injection. She was admitted to the intensive care unit (ICU) overnight and stayed approximately 24 hours. She did not require intubation. Treatment for the event included an epinephrine drip. On 30 Dec 2020, the hives and swelling returned. The patient planned to go to the hospital, but she was not sure if she would be admitted. Action taken with mRNA-1273 in response to the events was not reported. The events, swelling and hives, were considered not resolved. The reporter did not provide assessment for the events of swelling and hives.; Reporter's Comments: This case concerns a female patient with an extensive history of allergies, who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), who experienced unexpected events of urticaria and swelling and hives on the same day, approximately 7 minutes after vaccination. The reporter did not provide the causality assessment for the events. Due to the temporal association between the events (urticaria and swelling) and the administration of the vaccine, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/27/2020,12/27/2020,0.0,PVT,,Allergy (Takes diphenhydramine prior to influenza vaccine),,,,"['Intensive care', 'Swelling', 'Urticaria']",1,MODERNA,OT 1012375,FL,62.0,M,"muscle weakness of both legs; exacerbation of the baseline numbness of many areas of my body; This is a spontaneous report from a contactable consumer (patient himself). A 62-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, left arm, on 14Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included multiple sclerosis. Concomitant medication included gabapentin, tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), oxybutynin and vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]). The patient previously took diphenhydramine hydrochloride (BENADRYL) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 18Jan2021 at 11:00, the patient had muscle weakness of both legs to the extent that he could not stand. He had an exacerbation of the baseline numbness of many areas of his body. The event resulted in emergency room/department or urgent care visit and the patient was hospitalized for 2 days. The patient received intravenous antibiotics as treatment. The event was considered serious by the patient, requiring hospitalization. The patient's COVID test post vaccination via nasal swab on 18Jan2021 was negative then via blood test on 20Jan2021 was negative. The patient recovered from the events on an unspecified date. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/14/2021,01/18/2021,4.0,SEN,GABAPENTIN; FLOMAX [TAMSULOSIN HYDROCHLORIDE]; OXYBUTYNIN; VITAMIN B12 [VITAMIN B12 NOS],,Medical History/Concurrent Conditions: Multiple sclerosis,,,"['Blood test normal', 'Condition aggravated', 'Dysstasia', 'Hypoaesthesia', 'Multiple sclerosis relapse', 'Muscular weakness', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 1012376,MO,68.0,F,"her arm was red, swollen, and growing; her arm was red, swollen, and growing; She had numbness in parts of the ear and is now able to feel parts of the ear, but she is not sure if the numbness will go away; Caller mentioned that she can feel her ear ""closing up"" and by Saturday-Sunday had lost hearing on the right ear; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A 68-year-old female patient received her 1st bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Batch/lot number: EK9231) single dose on 22Jan2021 10:45 AM at right arm for COVID-19 immunization. Medical history included COVID on 05Nov2020 but was mild only and she was not hospitalized; No medications aside from over-the-counter drugs. The patient was given a Z-pack and vitamin C and immune stuff like Zinc. Concomitant drugs included high blood pressure medication. Around 6:00 PM on 22Jan2021, the patient can feel her ear ""closing up"" and by Saturday-Sunday had lost hearing on the right ear - the same side of her arm she received the vaccine. The patient stated it was better on 25Jan2021 but still not 100 percent. The patient tried calling the emergency room and has read up and no one can give her any answers. She made an appointment this morning with her doctor to see what was going on, states not being able to hear messes with her equilibrium. The patient was supposed to have another dose on 12Feb2021 and wanted to know if she should. The patient currently still had partial hearing loss and was prescribed a Prednisone that she took for 5 days. Her arm did not hurt Friday through Sunday, however, on Monday, her arm was red, swollen, and growing. She was able to get partial hearing back after taking Prednisone. She had numbness in parts of the ear and was now able to feel parts of the ear, but she was not sure if the numbness will go away. The outcome of hearing loss was resolving, of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Balance disorder', 'Deafness unilateral', 'Ear discomfort', 'Erythema', 'Hypoaesthesia', 'Peripheral swelling']",1,PFIZER\BIONTECH, 1012377,TX,32.0,F,"Delirium; headache; body chills; nausea; strong pressure felt in head and neck; strong pressure felt in head and neck; blurred vision; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9261, expiry date not reported) via an unspecified route of administration at left arm, on 22Jan2021 10:45, single dose, for COVID-19 immunization. Medical history included neoplasm malignant and hypersensitivity. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccine in the last four weeks. It was unknown if the patient has COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medication included alprazolam (XANAX) and doxycycline hyclate. On 22Jan2021 14:00, the patient experienced delirium, headache, body chills, nausea, strong pressure felt in head and neck, and blurred vision. Outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,SCH,XANAX; DOXYCYCLINE HYCLATE,,Medical History/Concurrent Conditions: Allergy; Cancer,,,"['Chills', 'Delirium', 'Discomfort', 'Head discomfort', 'Headache', 'Nausea', 'Vision blurred']",1,PFIZER\BIONTECH, 1012378,IN,81.0,F,"Dizzy; Headache; Joint pain; Fever; Injection site swelling; heartbeat would accelerate for a few seconds; Chills; off balance; throwing up; she could not drive and was half delirious; I am not feeling good; sneezing; has no energy; her bowel movement was little dab and then again another little dab; if she does not blow her nose, it feels like something is going down the back of her throat; She still has a punchy feeling; she does not have her peripheral vision right; Her arm felt like a boil where they gave her the shot.; Her arm is still is sore; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982, Expiry Date of Pfizer covid vaccine: May2021), intramuscular injection in left shoulder on 21Jan2021 13:00 at single dose as preventative, since she did not want to get COVID again/there was a new strain of COVID that was easier to catch. Medical history included ongoing high blood pressure diagnosed about 5 to 7 years ago, ongoing high cholesterol diagnosed about 5 to 7 years ago, thyroid disorder, Supplementation, for bones, COVID-19 from Nov2020 to Dec2020: She had COVID in Nov2020 till the end of Dec2020, and she was getting better. Concomitant medication included ongoing metoprolol tartrate for high blood pressure, ongoing simvastatin for cholesterol, ongoing levothyroxine for thyroid, ongoing colecalciferol (VITAMIN D) as Supplementation, for bones. The patient experienced chills, off balance, dizzy, headache, joint pain, fever, injection site swelling, heartbeat would accelerate for a few seconds on 21Jan2021, throwing up in Jan2021. The patient spent that whole night getting up and down and going to bathroom for bowel movement, and her bowel movement was little dab and then again another little dab. She was throwing up by 3am or 4am that night, she threw up twice and reports it was like bubbles. Her side effects started Thursday night. She experienced chills, joint pain, fever, injection site swelling, her heartbeat every so often would accelerate for a few seconds. She dizzy and off balance when she would get up to go the bathroom. Since then she still had sneezing and she was blowing her nose, and if she did not blow her nose, it felt like something was going down the back of her throat. She wanted to ask how long she would experience the side effects and how many people had a problem with the first dose. She still had a punchy feeling, had no energy. She could lay down and fall asleep at almost anytime. Height: about 5'2'', she jokingly stated she was shrinking monthly. Her chills started Thursday night and by Saturday morning they were completely gone. When she tried to turn a corner and reported she did not have her peripheral vision right since she kept running into door frames. She was a little better, sometimes she could walk a straight line and sometimes she veers. Headache was ongoing. She did not have it today, it was not a severe headache, it was more irritating than severe. Her arm felt like a boil where they gave her the shot. Her fever went away Saturday night or Sunday morning. She felt like she was not in her own mind, like she was drifting, so time lines for side effects are hard to recall. Her arm was still was sore. Heartbeat would accelerate for a few seconds was occasionally still happening, it happened last night. She called the hospital (facility where it was received) back the next morning and she was told she could come if she wanted to but it was suggested to stay home and sleep it off. She told them she could not drive and was half delirious, she was told she could call an ambulance to come get her. She confirms she did not call ambulance or go to the hospital. When querying indication, she was told there was a new strain of COVID that was easier to catch. The outcome of events chills was recovered on 23Jan2021, vomiting was recovered on 22Jan2021, joint pain was recovered on 24Jan2021, fever recovered in Jan2021. The outcome of events balance impaired NOS, dizzy, vaccination site swelling, Peripheral vision defective was recovering. The outcome of event headache, sneezing, feeling of total lack of energy, feeling abnormal, sleep excessive and pain in arm was not recovered. The outcome of rest events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/01/2021,,PVT,METOPROLOL TARTRATE; SIMVASTATIN; LEVOTHYROXINE; VITAMIN D [COLECALCIFEROL],Blood pressure high (Verbatim: high blood pressure diagnosed about 5 to 7 years ago); High cholesterol (diagnosed about 5 to 7 years ago),Medical History/Concurrent Conditions: COVID-19 (She had covid in Nov2020 till the end of Dec2020); Supplementation therapy; Thyroid disorder,,,"['Arthralgia', 'Asthenia', 'Balance disorder', 'Chills', 'Dizziness', 'Feeling abnormal', 'Frequent bowel movements', 'Gait disturbance', 'Headache', 'Heart rate increased', 'Impaired driving ability', 'Injection site discomfort', 'Injection site swelling', 'Oropharyngeal discomfort', 'Pain in extremity', 'Pyrexia', 'Sleep disorder', 'Sneezing', 'Somnolence', 'Upper-airway cough syndrome', 'Vaccination site swelling', 'Visual field defect', 'Vomiting']",1,PFIZER\BIONTECH,OT 1012379,IL,,F,"Hallucinations; extremely tired/extremely lethargic; extremely tired/extremely lethargic; she wasn't making any sense; UTI; This is a spontaneous report from a contactable consumer. A 88-years-old female patient (mother) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunization. Medical history included dementia. The patient's concomitant medications were not reported. Reporter was asking if Hallucinations are a side effect of the vaccine. Her mother (patient) got the first dose of the covid vaccine on 23Jan2021. She reported that after getting the vaccine her mother was initially extremely tired but she was still able to carry on regular conversation until this morning when she wasn't making any sense. Reporter stated that this may be due to a possible UTI but she just wanted to see if older people with dementia were having hallucinations after getting the vaccine. It was reported that patient was extremely lethargic and having hallucinations. Reporter was wondering if this could be a reaction to the vaccine. All event from Jan2021. The outcome of the events was unknown. Information on batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to event hallucinations cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Dementia,,,"['Conversion disorder', 'Fatigue', 'Hallucination', 'Lethargy', 'Mental status changes']",1,PFIZER\BIONTECH, 1012380,,,F,"hypothermia; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (reported as 48, unknown unit) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced hypothermia after receiving the 1st dose of the COVD-19 vaccine last 15Jan2021. She wanted to check if there are reported cases for hypothermia, coldness of hands and feet and recorded body temperature was 95.7 F; all on an unknown date in Jan2021 and unknown outcome. The patient was advised that there was no information available about hypothermia after getting the 1st dose. Information on Lot/Batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported hypothermia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/01/2021,,UNK,,,,,,"['Body temperature decreased', 'Hypothermia', 'Peripheral coldness']",1,PFIZER\BIONTECH, 1012381,MA,24.0,F,"felt herself losing consciousness; Low blood pressure following event (50/20); My vision went blurry first; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 25Jan2021 at 09:30 at a single dose in the workplace clinic for COVID-19 immunization. Medical history included asthma and history of vasovagal syncope following vaccinations; this adverse reaction to the vaccination directly aligns with other episodes that have occurred to her following vaccinations/interactions with needles (ie. blood draws). The patient had no COVID prior to vaccination. The patient is not pregnant. Concomitant medication included levonorgestrel (MIRENA). On 25Jan2021 at 09:30 (after getting the vaccine), the patient felt herself losing consciousness, her vision went blurry first and she was able to brace herself by lying down against a wall, and low blood pressure following event (50/20). Blood pressure and pulse rose over the next 25 minutes. 15 minutes more of observation was completed. The patient did not receive treatments for the events. The patient was not tested for COVID post vaccination. The patient recovered from the events. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,WRK,MIRENA,,Medical History/Concurrent Conditions: Asthma; Syncope vasovagal (occurred to her following vaccinations/interactions with needles (ie. blood draws)),,,"['Dizziness', 'Heart rate decreased', 'Hypotension', 'Loss of consciousness', 'Vision blurred']",1,PFIZER\BIONTECH, 1012382,PA,41.0,M,"Belly's palsy, right side of face; This is a spontaneous report from a contactable physician. This physician reported for a 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient medical history included anxiety, cervical myofascial pain syndrome, gastrooesophageal reflux disease (GERD), known allergies: eggs, detergent. The patient's concomitant medications were not reported. The patient previously took salbutamol (ALBUTEROL), diphenhydramine hydrochloride (BENADRYL), esomeprazole (NEXIUM), prochlorperazine (COMPAZINE) and experienced allergies. The patient experienced Belly's palsy, right side of face on 25Jan2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included prednisone and valaciclovir (VALACYCLOVIR). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association and lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported Belly's palsy, right side of face and the administration of the COVID-19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/25/2021,5.0,UNK,,,Medical History/Concurrent Conditions: Anxiety; Detergent sensitivity; Egg allergy; GERD; Myofascial pain syndrome,,,['Facial paralysis'],UNK,PFIZER\BIONTECH, 1012383,MI,69.0,F,"felt like she was having the onset of pneumonia; muscle and body aches; muscle and body aches; ongoing congestion in one nostril/stuffiness; felt tired and run down; feeling itchy/Her head, neck and back are very itchy; rash/like a fever type rash; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3249, unknown expiration), via an unspecified route of administration in the left shoulder area on 16Jan2021 at 11:15 AM at a single dose for COVID-19 immunization. Medical history included COPD (has it for lots of years) and nickel sensitivity. She does not have any reactions to her previous unspecified vaccines but had a normal reaction like sore arm. Concomitant medication included bimatoprost (LUMIGAN). The patient previously received flu vaccine and pneumonia vaccine, both for immunization in 2020 around the end of Sep or beginning of Oct. The patient reported side effects regarding the COVID vaccine and said she was a little confused and unsure if she was having a problem or if she should see a doctor. On 16Jan2021 at 11:15 AM, she had the first dose of the COVID vaccine and afterward she had a lot of effects which were mostly muscle and body aches in Jan2021. She also experienced some ongoing congestion in one nostril but saw this as just more congestion and that she was having to blow her nose more in Jan2021. She did the (app name) report but didn't report the stuffiness. She did report that in the first few days she felt like she was having the onset of pneumonia and felt tired and run down (Jan2021). Two days ago, she started feeling itchy (Jan2021) and she didn't know what it was, she didn't know if she ate something or what. Now she has developed a rash (Jan2021) which is ongoing until now. Her paperwork said the rash would happen right away if it was caused by the vaccine. The patient wanted to know if this is something she should be concerned about and if the rash could appear or started this long after she had the vaccine. Her second dose is due on 06Feb2021. The patient wanted to know if the vaccine contains nickel or any metal substances in it since she had compared her rash to her nickel sensitivity. The patient wanted to know if rash is a side effect from the vaccine and how long it will last. She didn't put rash down for the safety check either as she didn't know if it was caused by the vaccine. Today her rash, she is so itchy. She does have it on her neck and certain areas but not everywhere. It looks like what would happen after a bad fever. It is not raised but is like a fever type rash. She did note that she had an increase dose of a medication eye drops (Lumigan; Lot: T and a 0 or O followed by 544, and NDC: 0023320503. Expiry: Jan2022) around the time the rash started but after getting the vaccine. Her head, neck and back are very itchy. She mentioned that she waited 2 days and did not put this event in the (app name). She would have reported it yesterday, but she didn't get one yesterday. She also noted that it was very dry there and cold and a person is going to get dry skin. She does have an allergic to metal and wondered if that was in the product. In her neck area, it looks just like when she would wear a cheap necklace. No treatments received. The events did not require emergency room or physician office visit. The patient has no prior vaccination within four weeks. The patient had not yet recovered from events rash/like a fever type rash and congestion in one nostril/stuffiness; while unknown outcome for the remaining events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/01/2021,,UNK,LUMIGAN,,Medical History/Concurrent Conditions: COPD (has it for lots of years); Nickel sensitivity; Pain in arm (from previous unspecified vaccines),,,"['Confusional state', 'Fatigue', 'Myalgia', 'Nasal congestion', 'Pain', 'Pruritus', 'Rash', 'Rash pruritic', 'Trichomoniasis']",1,PFIZER\BIONTECH, 1012384,WI,75.0,U,"atrial fibrillation; heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 75-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3248) via an unspecified route of administration on 21Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included palpitations years ago. The patient's concomitant medications were not reported. Patient received the vaccine at 15:00 on 21Jan2021 and around 20:00, patient started getting heart palpitations. Years ago patient did have palpitations at times but had not had them like this that did not go away. Patient went to ER and the heart monitor showed patient had atrial fibrillation. Patient was sent home to follow up with primary care physician. Patient would be seeing her this coming Thursday. This was the fourth day after patient shot and patient was still bothered by them. No treatment received. Patient asked if it was the vaccine that started these palpitations up. No covid prior vaccination. No covid tested post vaccination. The patient underwent lab tests and procedures which included heart monitor showed atrial fibrillation in Jan2021. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Palpitations (years ago),,,"['Atrial fibrillation', 'Cardiac monitoring abnormal', 'Condition aggravated', 'Palpitations']",UNK,PFIZER\BIONTECH, 1012385,,,F,"fluid on her heart caused by a virus; fluid on her heart caused by a virus; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration on (lot number and expiry date unknown) at single dose for Covid-19 immunization. Medical history included low fever from 01Jan2021 (negative for covid on 01Jan2021). The patient's concomitant medications were not reported. On 14Jan2021, the patient was hospitalized for fluid on her heart caused by a virus on unspecified date. The patient was scheduled to take her second dose of the vaccine on Saturday (unspecified date). The patient would like to know if she would be able to get her second dose of the Pfizer Covid vaccine after the side effects she experienced post-vaccination on the first dose. Her family doctor has told her to wait 90 days. She was also scheduled to visit her cardiologist tomorrow. The outcome of the events fluid on her heart caused by a virus was unknown. Follow-up activities are possible, information on the batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/09/2021,,,UNK,,,Medical History/Concurrent Conditions: Fever (negative for covid),,,"['Pericardial effusion', 'Viral pericarditis']",1,PFIZER\BIONTECH, 1012553,WI,,F,"bronchospasms; This is a spontaneous report from a non-contactable pharmacist. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiry date: unknown), intramuscular on 21Jan2021 at a single dose for covid-19 immunization. The patient's medical history included chest pain in the past (has experienced this on and off unrelated to medication administration). Concomitant medications were not reported. The patient previously took first dose of bnt162b2 on unspecified date for covid-19 immunization. The patient is not pregnant. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 21Jan2021, the patient complained shortly after second dose of covid vaccine, having what she felt were bronchospasms. Medical Emergency Rapid Response call was made. RRT personnel arrived and administered 2 puffs of albuterol inhaler with subsequent improvement of status. No other complaints of chest pain, etc. It was reported that the event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of the event. Outcome of the event was recovered on unspecified date in Jan2021.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Chest pain (has experienced this on and off unrelated to medication administration),,,['Bronchospasm'],2,PFIZER\BIONTECH,OT 1012554,,,F,"cataract; This is a spontaneous report from a non-contactable consumer (patient's daughter) via medical information team. An 84-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 18Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the COVID vaccine on 18Jan2021 and was scheduled for 08Feb2020 for the second dose. In between that she needed to have cataract surgery, if she can't make it to the second dose. The consumer wanted to know what would happen if she received the second dose outside of the 21 days and she wanted to know what was the timing of the second dose of PFIZER-BIONTECH COVID-19 VACCINE and can it be received earlier or later than 3 weeks. The event was considered non-serious by the reporter. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,,,UNK,,,,,,['Cataract operation'],1,PFIZER\BIONTECH, 1012556,VA,71.0,M,"Two episodes of delirium, vomited twice/two times now woke up delirious not knowing where he was; Two episodes of delirium, vomited twice; Got sick; Couldn't get up; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on the right arm on 19Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included liver cancer and chemo. There were no concomitant medications. It was reported that for two times, the patient woke up in the morning delirious, did not know where he was, hollering for his wife, couldn't get up, got sick and vomited, after he got up he felt pretty good. States he fell asleep on couch that night, toward morning he rolled onto floor, flopping around on floor like a wet seal, flopping arms around tried to roll over, pulled muscle in rib cage, after he got back up, got sick and had to vomit. Once he got up and went to the bathroom and all of that went away, wanted to know if this is this related to the Covid vaccine. This morning (unspecified date) he laid on the couch and he was about half scared to lay down because he was afraid something would happen again. The patient confirmed that he experienced this twice the day after or a couple days after the vaccine (unknown date). The patient stated that it has not happened again. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,,,UNK,,,Medical History/Concurrent Conditions: Cancer of liver resectable; Chemotherapy,,,"['Delirium', 'Disorientation', 'Dyskinesia', 'Fall', 'Malaise', 'Mobility decreased', 'Muscle strain', 'Vomiting']",1,PFIZER\BIONTECH, 1012557,NC,80.0,F,"Amyloidosis; felt a sweep over her stomach up her body and up to her head; Eyes swollen; hands hurt; sharp pings up and down legs; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the left arm on 16Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included ongoing diabetic and previously took the flu shot one time and started having right arm pain across her chest over to the left side right after getting it. So she don't take it anymore and takes a bunch of herbs. The patient's concomitant medications were not reported. The patient reported that she has a disease, amyloidosis on an unspecified date, where there is a build up of protein in the body. She didn't know that there is protein in the shot and doesn't know the affects it has with her condition. She found out the day after getting the first Pfizer C-19 (clarified as COVID-19) shot that there was protein in it. The patient wanted to know the affects it has with her condition and if it will affect her getting the second dose and if it covers the new virus and booster shot. The patient got the vaccine on 16Jan2021 and found out about the protein in it the next day when it came across her phone. The patient received it at a school, where they vaccinated 1,169 residents. They text her to inform her she could get the vaccine. They also have the health department there. No other vaccines given that day or 4 weeks prior. On an unspecified date in Jan2021, the patient took 1 Tylenol about 15:00 that afternoon and seated herself in the chair about 17:45, then she felt a sweep over her stomach up her body and up to her head. She stood up and walked around to see if she was going to faint and she did not faint. She walked through the house and nothing else happened. The patient mentioned that her eyes have been swollen and her hands hurt, that's where the protein build up comes in the body. Has pings up and down her legs, they are sharp pings that lasted through on to Tuesday. She took 1 Advil to help and as of yesterday (as reported) no pings. Her hands still hurt, because this condition forms chains in the body and the chains are around the hands like carpel tunnel. The protein normally should leave the body and with this condition it doesn't and it leaves chains. When she was diagnosed with it they took a spot off the ankle to test it, the Dermatologist did and sent it off. No further details provided. Wants to know the affects of her getting the second shot. No further details provided. The outcome of the events amyloidosis and hands hurt was not recovered, the events felt a sweep over her stomach up her body and up to her head and sharp pings up and down legs was recovering, and the event eyes swollen was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/01/2021,,UNK,,Diabetic,Medical History/Concurrent Conditions: Flu vaccination,,,"['Amyloidosis', 'Carpal tunnel syndrome', 'Condition aggravated', 'Dizziness', 'Eye swelling', 'Feeling abnormal', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 1012562,MO,84.0,F,C/o generalized weakness/dizziness/headache after receiving vaccine. Was seen in the ED on 1/6/21. Feeling weak and unable to stand up. ER labs unremarkable. Admitted to hospital. After received Azithromycin and Rocephin patientt reports feeling much better. Following day reports feeling symptom free.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/05/2021,02/06/2021,1.0,PUB,Unknown,Previous infection with COVID-19. Diagnosed on 1/16/21. Released from quarantine on 1/27/21.,Unknown,,Unknown,"['Asthenia', 'Blood test normal', 'Chest X-ray abnormal', 'Dizziness', 'Dysstasia', 'Headache']",1,MODERNA,IM 1012604,GA,76.0,M,Death,Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,01/11/2021,02/05/2021,25.0,PUB,,,,,,['Death'],1,MODERNA,IM 1012612,,79.0,M,Patient was hospitalized on 31 Jan for COVID pneumonia after 3 days of increasing baseline supplemental O2 requirements and dyspnea and ultimately died on comfort care on 3 Feb 2021.,Yes,02/03/2021,Not Reported,Yes,3.0,Not Reported,N,01/21/2021,01/01/2021,,PVT,albuterol apixiban diclofenac exenatide finasteride furosemide lantus novolog liptor lotrel metoprolol succinate pantoprazole levothyroxine tasulosin tiotropium-olodaterol,COPD exacerbation 2 weeks prior,Atrial fibrillation on anticoagulation benign prostatic hyperplasia CKD stage 3 Chronic obstructive pulmonary disease - on baseline 2L NC supplemental O2 Gastro-esophageal reflux disease Hyperlipidemia Hypertension Hypothyroidism Obstructive sleep apnea Type 2 diabetes mellitus asbestosis,,None,"['COVID-19 pneumonia', 'Death', 'Dyspnoea']",UNK,MODERNA, 1012636,MN,78.0,M,"Resident was desated, into the 80's, short of breath. We went him to the hospital same day as vaccine given",Not Reported,,Yes,Yes,3.0,Not Reported,U,02/02/2021,02/02/2021,0.0,SEN,Metoprolol Finestride Flomax Zofran Serequel Donepezil Ativac Prednisone,"hx of recurrent C-diff, Divertivulitis in Dec 2020, hx of covid positive Oct 2020.","Dementia, HTN, Anemia, Hx of CVA, Parkinsonism, CKD, CAD, Cardiac Thrombosis, Rheumatoid Arthritis.",,No known Allergies,"['Clostridium difficile infection', 'Dyspnoea', 'Endotracheal intubation', 'Oxygen saturation decreased', 'Urinary tract infection']",UNK,MODERNA,IM 1012665,TX,48.0,M,"Moderna Covid Vaccine - Received 2nd dose of vaccine and acutely developed fever, chills, diffuse myalgia, and fatigue. Patient felt week to the point he could not walk. Denies headache, photophobia, neck stiffness, SOB, chest pain, cough, N/V/D, abdominal pain. Denies recent illness or sick contacts. Wife and patients denied any symptoms prior to receiving Covid vaccination. Past Medical History includes: metastatic clear-renal cell CA; receiving nivolumab/ipilimumab. SoluCortef 15mgAM/5mgPM initiated on 12/31. Last chemotherapy received on 01/22/21; S/P left nephrectomy In the ED, patient was started on vanc/zosyn/azithromycin, SoluCortef 100 mg, IVFluid and levophed (for MAP 62-64). Patient was admitted to the MICU for undifferentiated shock. Hemodynamically stable after weaned off low-dose levophed . Etiology likely infectious vs Adrenal insufficiency vs reaction to COVID vaccine. SoluCortef decreased to 50mg q6H. Acute kidney injury; likely secondary to shock.",Not Reported,,Not Reported,Yes,,Not Reported,,01/27/2021,01/27/2021,0.0,UNK,,,,,Allergies - no know drug allergies Denies - alcohol or tobacco use History of clear renal cell carcinoma Adrenal insufficiency secondary to chemotherapy,"['Acute kidney injury', 'Asthenia', 'Blood creatinine increased', 'Chills', 'Fatigue', 'Full blood count', 'Gait disturbance', 'Intensive care', 'Myalgia', 'Pyrexia', 'Shock']",2,MODERNA,IM 1012692,MN,1.42,F,"This child died unexpectedly the following morning in her sleep. She has been diagnosed with SUDC (sudden unexplained death of a child). Preliminary autopsy did not uncover any medical issues or problems. There is further testing being done and it may be a few months before all tests are done and final report is available. I do not submit this event as evidence of the cause of this child's death. However, I need to report this event as it is not clear whether or not the vaccine(s) are related. I had initially planned to wait until final autopsy results were available, but that is taking very long and I wanted to make this report. I submit it today and can provide final autopsy report when I receive it.",Yes,10/27/2020,Not Reported,Not Reported,,Not Reported,N,10/26/2020,10/27/2020,1.0,PVT,none,"mild URI symptoms the month prior, so didn't have her vaccines at that time. She came back for vaccines on 10/26/2020.",none,,Amoxicillin allergy,"['Autopsy', 'Death', 'Sudden death']",4,PFIZER\WYETH,IM 1012693,KY,89.0,M,"Administered Patient vaccine 01/21/21. Went to ED and diagnosed with the following: 1. Shortness of breath 2. Peripheral edema 3. Hypertensive urgency 4. Weight gain 5. Hypervolemia, unspecified hypervolemia type 6. Atypical chest pain Admitted to inpatient to hospitalist but then signed AMA and left hospital.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/24/2021,02/04/2021,11.0,PVT,,"CHF, HTN, LYMPHEDEMA","CHF, HTN, LYMPHEDEMA",,NKA,"['Atelectasis', 'Blood pressure increased', 'Chest X-ray abnormal', 'Chest pain', 'Condition aggravated', 'Dyspnoea', 'Haematocrit abnormal', 'Haemoglobin abnormal', 'Hiatus hernia', 'Hypertensive urgency', 'Hypervolaemia', 'Oedema peripheral', 'Prothrombin time abnormal', 'Prothrombin time ratio abnormal', 'Red blood cell count abnormal', 'Refusal of treatment by patient', 'Weight increased']",1,PFIZER\BIONTECH,IM 1012703,NH,85.0,M,"1/14/2021-0545, blood noted left and right ear. 0715, vomited x 1. Covid Antigen positive. Acute MD visit-basilar crackles right and coughing. Increased confusion.",Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/14/2021,7.0,SEN,Aspirin Tablet 81 MG clonazePAM Tablet 0.5 MG Colace Capsule 100 MG DULoxetine HCL Furosemide Tablet 20 MG Norvasc Tablet 10 MG Potassium Chloride ER CapsulE QUEtiapine Fumarate Tablet Galantamine Hydrobromide Tablet,"Intermittent delusional periods-followed by Generations Mental Health.1/6 Increased BLE edema, BP trending up. Acute visit with APRN, N.O. started Lasix & KCL. CBC and BMP ordered for 1/8 with elevation in BMP/Creatinine. Lasix and KCL placed on hold. On palliative services presently.","Alzheimer?s Disease/Depression; HTN; CAD, CKD, AAA w/o Rupture, no surgical intervention per ADPOA, Dyslipidemia, GERD.",,HEPARIN LATEX BLEACHED SHEETS,"['Blood calcium normal', 'Blood chloride increased', 'Blood creatinine increased', 'Blood glucose increased', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea increased', 'COVID-19', 'Carbon dioxide normal', 'Confusional state', 'Cough', 'Differential white blood cell count normal', 'Ear haemorrhage', 'Fibrin D dimer increased', 'Full blood count', 'Glomerular filtration rate decreased', 'Haematocrit decreased', 'Haemoglobin normal', 'Mean cell haemoglobin concentration decreased', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Mean platelet volume normal', 'Metabolic function test', 'Nucleated red cells', 'Platelet count normal', 'Rales', 'Red blood cell count decreased', 'Red cell distribution width normal', 'SARS-CoV-2 test positive', 'Thrombosis', 'Vomiting', 'White blood cell count normal']",1,PFIZER\BIONTECH,IM 1012717,FL,83.0,M,Patient that received his first dose of Pfizer vaccine on 2/1/2021 passed away on 2/2/2021. No further information is available at this time.,Yes,02/02/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/02/2021,1.0,PUB,unknown,unknown,unknown,,No per screening form completed,['Death'],1,PFIZER\BIONTECH,IM 1012742,NE,61.0,M,"1/31/21 0730 am confused and low grade temp 99.5, 12 noon Temp 100.6 and sitting in recliner non responsive twitching. Sent to Hospital with EMS to rule out stroke. Admitted 1/31/21.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/30/2021,01/30/2021,0.0,SEN,"VITAMIN D 2000 IU TABLET, VALPROIC ACID 250 MG/5 ML SYRUP (Valproic Acid) 5mL (250mg) Oral TWICE DAILY, VALPROIC ACID 250 MG/5 ML SYRUP (Valproic Acid) 10mL (500mg) Oral HS, DONEPEZIL HCL 5 MG at HS,",none,"M06.9 Rheumatoid arthritis, unspecified; F33.8 Other recurrent depressive disorders; F31.9 Bipolar disorder, unspecified; M17.0 Bilateral primary osteoarthritis of knee; M54.5 Low back pain; M51.37 Other intervertebral disc",,KNMA,"['Computerised tomogram head', 'Confusional state', 'Laboratory test normal', 'Muscle twitching', 'Pyrexia', 'Transient ischaemic attack', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 1012749,FL,60.0,F,"12/22 Vaccination 4 hours later, chest pain. Felt heavy. Got extremely sleepy. I tried to lay down, episode of syncope. Chest discomfort. ER for observation",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,12/22/2020,12/22/2020,0.0,WRK,"Vitamins, fish oil, probiotic",*motorcycle accident 03/2020 (issues since then),CAD,,,"['Chest discomfort', 'Chest pain', 'Electrocardiogram normal', 'Limb discomfort', 'Somnolence', 'Syncope']",1,PFIZER\BIONTECH,SYR 1012795,CT,88.0,M,Patient was administered second dose of Pfizer vaccine in Nursing Home on 2/5/2021 around noon and was found unresponsive at 5:03AM the following day 2/6/2021. Patient arrived to Hospital in cardiopulmonary arrest and was pronounced dead.,Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,SEN,Unknown,Unknown,"Hypertension, Coronary Artery Disease, Previous Myocardial Infarction, Atrial Fibrillation, Hyperlipidemia, Arthritis",,"Adhesive Tape, Niacin, Banana, Bandaids, Benzodiazepines, Calcium Channel Blockers, Digoxin, Hydralazine, Levaquin, Minoxidil, Tomatoes, Oranges","['Cardio-respiratory arrest', 'Death', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 1012807,WA,30.0,F,"first 3 days, my arm was sore; On the 9th - I developed upper gastric pain that was radiating through my back up to my upper right shoulder. I was concerned since I'm pregnant that it might have to do with the pregnancy. By 2:00 pain had progressively worsened and I didn't have much of a appetite that day. Around 3:30, I started developing intense nausea - and vomited 3:45 pretty violently. I contacted the OB - and she thought I should come in to be monitored. Hospital is where I went and I got there and they monitored to see how baby was doing; did a urine test - found protein and ketones in there. Drew labs - lipase was significantly elevated - 324. 156 were where my Triglycerides were at- a bit out of range. They dx'd me with Pancreatitis - idopathic since they couldn't determine cause. They admitted me to Hospital from 9th - 16th. While I was in the hospital they did further lab work. I was showing malnourished - after a clear liquids only for two days. I asked to be discharged by 16th. On the 29th, the day I took the vaccine - I had a glucose tolerance test after the vaccine (about 08:30 AM is when I started the glucose monitoring test) - they diagnosed me with gestational diabetes with that two days after vaccine on December 31st. Expected due date - April 20, 2021; low PAP A hormone; 1st pregnancy",Not Reported,,Yes,Yes,8.0,Not Reported,Y,12/29/2020,01/09/2021,11.0,PVT,Doxepin; pregnancy prenatal vitamin,no,no,,Benadryl; seasonal allergies; fruits and vegetables because of the pollen; milk and peanuts,"['Abdominal pain upper', 'Arthralgia', 'Back pain', 'Blood glucose', 'Blood test', 'Blood triglycerides increased', 'Condition aggravated', 'Decreased appetite', 'Exposure during pregnancy', 'Foetal non-stress test', 'Gestational diabetes', 'Glucose tolerance test abnormal', 'Hormone level abnormal', 'Lipase increased', 'Magnetic resonance cholangiopancreatography', 'Malnutrition', 'Nausea', 'Pain', 'Pain in extremity', 'Pancreatitis', 'Protein urine present', 'Ultrasound biliary tract normal', 'Urine ketone body present', 'Vomiting']",1,MODERNA,SYR 1012825,NE,74.0,M,"1/30/21 late night started to vomit, 1/31 am temp 102 and non responsive, sent to hospital via EMS",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/30/2021,01/30/2021,0.0,SEN,"AM LANTUS 100 U/1 ML SOLUTION (Insulin Glargine, Recombinant) 40 units Subcutaneous, NOVOLOG 100 U/1 ML SOLUTION (Insulin Aspart, Recombinant) 10u Subcutaneous BEFORE MEALS, METOPROLOL SUCCINATE 25 MG TABLET, EXTENDED RELEASE (Metoprolol Su",Cellulitis to leg,"CHF, Dysphagia, A-Fib, CAD, Diabetic 2, COPD, Sleep apnea, Major Depression, anemia, GERD, Chronic Kidney disease stag e3, BPH, gout, hypothyroid, hyperlipidemia, hypokalemia,",,"Bactrim, Ceftrriaxone, Levofloxacin, Metformin, Sulfamethoxazole","['Body temperature increased', 'Pyrexia', 'Unresponsive to stimuli', 'Vomiting']",2,PFIZER\BIONTECH,IM 1012831,WI,65.0,M,"Records review utilized to obtain information: Pt recieved his first dose of the Pfizer COVID-19 vaccine on 1/27/2021, unable to determine location that administered vaccine. Pt called to his PCP and indicated he was experiencing ""intense, but intermittent stomach pain in the LUQ since the day after receiving vaccine. He stated he was not eating due to the pain, and that nausea and vomiting would occur when eating. His wife and son both tested positive for COVID-19 per PCR on 1/29 (unknown what type of test). He was tested on 1/25 prior to vaccination and was negative at that time. He ended up going to the ER later that day and is recorded as having a fever and cough at that time, in addition to the pain as described above. Pt tested positive at this time on admission testing (2/5/2021). He is still currently inpatient at our facility.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/27/2021,02/05/2021,9.0,UNK,"albuterol inhaler, amlodipine, aspirin, atorvastatin, folic acid, calcium carbonate, metoprolol, pantoprazole, prednisone",,"DM type 2, tubular adenoma of colon, gout, stable angina, PTSD, pancytopenia, nephrocalcinosis, MDRO recorded from 2017, leukocytosis, hypovitaminosis, HTN, ESRF on hemodialysis, dyslipidemia, diabetes, depression, CAD, CKD stage 4, anemia, agranulocytosis, Idiopathic thrombocytopenic purpura",,No known allergies,"['Abdominal pain upper', 'Cough', 'Exposure to SARS-CoV-2', 'Feeding disorder', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test positive', 'Vomiting']",1,PFIZER\BIONTECH, 1012836,PA,67.0,M,"Isolated fever to 103.2 on 2/4 - resulted in hospitalization. He was febrile to 102 on arrival with WBC count 11.9 with a L shift, leukocytosis resolved within 2 days, no further fevers documented afte rthat. CXR with most likely atelectasis. Pt unable to provide history, staff not observing respiratory symptoms, pt on room air. Initially started on vanc/zosyn despite negative procalcitonin -> AKI -> repeat procalcitonin minimally elevated (likely due to vanc/zosyn combination), stopped antibiotics, AKI resolved and procalcitonin again normal.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/01/2021,02/05/2021,4.0,PVT,Acetaminophen [Tylenol :] 650 mg PO Q6HPRN PRN 02/04/21 Bisacodyl [Dulcolax:] 10 mg RECTAL DAILYPRN PRN 02/04/21 Clonazepam [Klonopin:] 0.5 mg PO DAILY 02/04/21 Divalproex Delayed Rel. 12 Hr [Depakote:] 125 mg PO HS 02/04/21 Doxepin [Si,None reported,"dementia, drug induced Parkinsonism , Former ETOH use disorder, COPD",,Contrast,"['Acute kidney injury', 'Atelectasis', 'Chest X-ray abnormal', 'Leukocytosis', 'Neutrophil percentage increased', 'Procalcitonin increased', 'Pyrexia', 'White blood cell count increased']",2,PFIZER\BIONTECH,UN 1012842,NY,74.0,F,"74 yo woman living in a group home for people with developmental disabilities. She has longstanding difficult-to-control seizure disorder, on valproate, lamotrigine, and levetiracetam. She had asymptomatic COVID-19 infection in November 2020, probably discovered in the course of surveillance testing of residents/staff, perhaps in relation to an outbreak in the residence. Sometime during the night following her vaccination earlier that morning, she developed a fever, and then was found to be having a generalized tonic-clonic seizure. Estimates of duration in the records range from 20 to 40 minutes. She was brought by ambulance to Hospital ED, and then admitted. Her temperature was said to be 103 F. She received midazolam, and at least one dose of IV antibiotics. By the evening of admission on 5 February 2021, she was still unresponsive. On arrival, her COVID-19 PCR was again/still positive. She had no prodromal symptoms suggesting COVID-19 reinfection, nor did anyone in the group home, staff or residents. Her initial WBC was normal but with a slight left shift. UA was normal. Head CT showed her known cerebral atrophy and chronic microvascular disease. Admitting valproate serum level was subtherapeutic; levatiracetam and lamotrigine levels were therapeutic. Blood cultures are no growth at 2 days. Urine culture negative. By hospital day 2, her transaminases had bumped to over 1000.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/04/2021,02/04/2021,0.0,PUB,"ACETAMINOPHEN 650 MG ORAL TABLET, EXTENDED RELEASE, 650 MG= 1 TAB(S), PO (ORAL), Q4H ACIDOPHILUS EXTRA STRENGTH ORAL CAPSULE, 1 CAP(S), PO (ORAL), QDAY, 3 REFILLS ALBUTEROL 2.5 MG/3 ML (0.083%) INHALATION SOLUTION, SEE INSTRUCTIONS, 3 REF",,"AMS (ALTERED MENTAL STATUS) ASPIRATION PNEUMONITIS CHRONIC BACK PAIN CHRONIC KIDNEY DISEASE, STAGE 3 DISEASE CAUSED BY 2019-NCOV DYSPHAGIA, OROPHARYNGEAL PHASE ELEVATED TSH SEIZURE DISORDER (partial complex epilepsy) GERD (GASTROESOPHAGEAL REFLUX DISEASE) GLAUCOMA H/O NUMMULAR ECZEMA HISTORY OF SQUAMOUS CELL CARCINOMA IN SITU OF SKIN HYPERLIPIDEMIA HYPERTENSION MENTAL RETARDATION PARKINSON DISEASE PRESSURE ULCER PSORIASIS UNSPECIFIED BRAIN DAMAGE DUE TO BIRTH INJURY VITAMIN D DEFICIENCY SQUAMOUS CELL CARCINOMA",,cephalexin (details unknown) lamictal (details unkown),"['Blood culture negative', 'Blood test', 'COVID-19', 'Computerised tomogram head', 'Computerised tomogram head abnormal', 'Culture urine negative', 'Generalised tonic-clonic seizure', 'Microvascular coronary artery disease', 'Pyrexia', 'SARS-CoV-2 test positive', 'Transaminases', 'Unresponsive to stimuli', 'Urine analysis', 'White blood cell count']",1,MODERNA,IM 1012854,NY,70.0,M,"COVID-19 Pfizer Vaccine dose #1 12/21/20 (Lot EJ1685); Tubersol TB test placed on the same day COVID-19 Pfizer Vaccine dose #2 1/11/21 (Lot EL1284) 1/12/2021: Patient presents to ED via EMS for chief complaint -- He stated that he was diagnosed with COVID-19 in November 2020. The patient has not had any recent Covid 19 exposures. He has not congregated with family members and others for Christmas. He comes in for shortness of breath to the ED that is accompanied by fever. Prior to getting his Covid vaccine 19 he was seen good health. The patient finds that he short of breath, dyspneic on exertion, and feels overall weak and fatigued. He has shaking chills according to him. Patient is diagnosed with PE likely due to untreated DVT (Patient reports ""taking girlfriend's coumadin"") from 1/7.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/11/2021,01/12/2021,1.0,SEN,,Hospitalized 11/28-12/16/20 for COVID-19 Went to rehabilitation nursing facility 12/16 (unknown length of stay) 1/7: diagnosed with DVT,"Paradoxical vocal cord motion disorder On home oxygen therapy COPD, severe Deep vein thrombosis (DVT) of left lower extremity Chronic respiratory failure with hypoxia Fever Lung nodule �",,penicillin,"['Angiogram', 'Angiogram pulmonary abnormal', 'Asthenia', 'Chills', 'Deep vein thrombosis', 'Dyspnoea', 'Dyspnoea exertional', 'Echocardiogram abnormal', 'Fatigue', 'Pulmonary embolism', 'Pyrexia', 'Tremor']",2,PFIZER\BIONTECH,IM 1012893,FL,57.0,F,"that evening i started to get a cold feeling down my arm and pain at injection site. later that night i had headache, nausea, body ache no fever very weak.. The next day i had body ache and all the same symptoms again. Then on the on the morning of the 29th woke up at 5:00 woke up to my head was killing me. Felt like my head was going to explode and i was disoriented. and i couldn't speak. couldn't even see to dial 911 or get my husband and after about 20 minutes or so i was able to get to my husband and he took me to the ER. There they gave me meds to get my blood pressure down and ended up admitting me to make sure i was not having a stroke. was in the hospital until that Sunday afternoon.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/27/2021,01/27/2021,0.0,PVT,,,heart palpitations,,,"['Aphasia', 'Asthenia', 'Blindness', 'Blood pressure increased', 'Blood test', 'Chest X-ray', 'Computerised tomogram', 'Disorientation', 'Electrocardiogram', 'Feeling cold', 'Full blood count', 'Headache', 'Injection site pain', 'Nausea', 'Pain', 'Peripheral coldness', 'Vision blurred']",2,MODERNA,IM 1012894,,85.0,F,"1-2 days after vaccine, pt developed weakness, fatigue, body aches, nausea, headache and poor appetite. Pt was admitted to the hospital on 2/5/21 and death occured on 2/6/21",Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,,01/22/2021,02/05/2021,14.0,UNK,Acetaminophen Amiodarone 100mg Diclofenac 1% gel Furosemide 40mg tablet Hydralazine 50mg tablet Metoprolol 100mg tablet Potassium Chloride 10meqER tablet Warfarin 2.5mg tablet,Anxiety A. Fib Cardiac Pacemaker Cerebral Infaction CHF Urinary Incontinence,,,NKA,"['Asthenia', 'Death', 'Decreased appetite', 'Fatigue', 'Headache', 'Nausea', 'Pain']",1,MODERNA,IM 1012897,AL,45.0,F,Employee reports having a stroke 2 weeks after vaccination that required hospitalization.,Not Reported,,Not Reported,Yes,,Not Reported,U,12/31/2020,01/14/2021,14.0,PVT,unknown,unknown,unknown,,"sulfa, ibuprofen, aloe",['Cerebrovascular accident'],1,PFIZER\BIONTECH,IM 1012926,NH,97.0,M,Early in the shift on January 31 resident was noticed to be more tired than usual and was not eating well. Lung sounds were crackly and resident was found to be hypotensive. He was evaluated in emergency department. He was diagnosed with pneumonia. Received a loading dose of antibiotic and returned to facility.,Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/31/2021,31.0,SEN,,,"CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED ATRIAL FIBRILLATION, ESSENTIAL (PRIMARY) HYPERTENSION ATRIOVENTRICULAR BLOCK, COMPLETE, NONINFECTIVE GASTROENTERITIS AND COLITIS, UNSPECIFIED, PERSONAL HISTORY OF PULMONARY EMBOLISM,",,NKA,"['Chest X-ray', 'Decreased appetite', 'Fatigue', 'Hypotension', 'Pneumonia', 'Rales']",1,PFIZER\BIONTECH,IM 1012927,MI,82.0,M,"Extremely SOB around 1AM...tremors in arms & legs. Did not respond to any options available, oxycodone, Ventolin, Nebulizer, for approximately 2 hrs. Couldn?t get air in or out. Did not call 911 because he didn?t want to die in hospital. Gave Boost drink & sipped on drink for dehydration. Breathing finally calmed a bit. Oxygen now at 84-92. Extreme weakness, arm has big red blotch. Next day still extremely weak & SOB. Must use walker & assistance getting to bathroom. No appetite. Can?t dress, cook, or anything. 6 days later, still weak, low appetite, has to double up on Nebulizer.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/02/2021,02/03/2021,1.0,PVT,Aspirin 81 mg Amlodipine. 5mg Atorvastatin. 40 mg Calcium carbonate 1500 x 2 per day Carvedilol. 3.125 x 2 per day Mucinex 600 mg x 2 per day Omeprazole 20 mg Prednisone 5 mg Spiriva inhaler Ventolin as needed Albuterol/ipatropi,NONE,COPD RA GERD STOKE,,Hydroxychloroquine sulfate,"['Asthenia', 'Decreased appetite', 'Dehydration', 'Dyspnoea', 'Gait disturbance', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Rash macular', 'Tremor', 'Walking aid user']",1,MODERNA,SYR 1012962,CA,43.0,M,"On Wednesday 1/27 the day after my second dose I felt a minor pinch/discomfort on my lower leg. I did not think much of that is reason I did not report it right away. Day by day the discomfort and pain got worse. Exactly one week after my second dose I was not able to sleep due to the pain. On Wednesday 2/3 I decided to go urgent care. From there I was referred for an ultra sound a few hours after. After the ultra sound I was contacted by my doctor, letting me know that the results showed I had a blood clot on my left leg. I was put on Eliquis medicine right away. On 2/5 I was able to physically see my doctor who told me that this was caused by the second dose of the moderne vaccine that I took on 1/26.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,WRK,None,None,None,,None,"['Adverse event following immunisation', 'Computerised tomogram', 'Electrocardiogram normal', 'Insomnia', 'Limb discomfort', 'Nerve compression', 'Pain', 'Sleep disorder', 'Thrombosis', 'Ultrasound Doppler', 'X-ray']",2,MODERNA,SYR 1012967,FL,44.0,F,"Unbalanced, confusion, vomiting, memory loss, & nausea.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/28/2021,02/03/2021,6.0,OTH,None,None,COVID-19 (+) in late July 2020.,,None,"['Amnesia', 'Balance disorder', 'Computerised tomogram head', 'Confusional state', 'Disorientation', 'Electrocardiogram', 'Electroencephalogram', 'Magnetic resonance imaging brain', 'Nausea', 'Scan with contrast', 'Vomiting']",2,MODERNA,IM 1012986,MA,70.0,M,"Hospitalized for community-acquired pneumonia and sepsis 6 days following administration of COVID-19 vaccine, complicated by acute hypoxemic respiratory failure and acute kidney injury requiring. Admitted to ICU, treated with intravenous antibiotics and initial pressor support. Intubated on hospital day #3, extubated on hospital day #8. Remains in ICU at time of this report.",Not Reported,,Not Reported,Yes,8.0,Not Reported,N,01/26/2021,02/01/2021,6.0,PVT,AMITRIPTYLINE - 10 mg tablet. 1-2 tablet(s) by mouth at night AMLODIPINE - 10 mg tablet. 1 tablet(s) by mouth HS ATORVASTATIN 80 mg. 1 tablet(s) by mouth every evening CARVEDILOL - 25 mg tablet. 1 tablet(s) by mouth twice a day - EVERO,,"- EtOH cirrhosis, orthoptic liver transplant in 2000 - DM glomerulonephrosclerosis, DDRT 2003 - RCC in transplanted kidney s/p excition - DM2 - Depression - Hypertension - Basal and squamous cell carcinomas - Diverticulitis - Peripheral neuropathy - CAD s/p NSTEMI in 2/08, s/p BMS to RCA and OM1 - PVD with multiple vascular stents in the bilateral lower extremities - History of C diff colitis",,cephalexin; hydromorphone; Neosporin ointment; Neosporin Scar Solution (Silicones/Adhesive Tape); Neosporin Scar Solution (Silicones/Adhesive Tape); Neupogen; Procrit,"['Activated partial thromboplastin time shortened', 'Acute kidney injury', 'Alanine aminotransferase normal', 'Anion gap', 'Aspartate aminotransferase normal', 'Blood alkaline phosphatase increased', 'Blood bicarbonate normal', 'Blood bilirubin normal', 'Blood chloride normal', 'Blood creatinine increased', 'Blood glucose increased', 'Blood glucose normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea increased', 'Chest X-ray abnormal', 'Endotracheal intubation', 'Haematocrit decreased', 'Haemoglobin decreased', 'Intensive care', 'International normalised ratio normal', 'Lung consolidation', 'Mean cell haemoglobin concentration decreased', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin decreased', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Platelet count decreased', 'Pneumonia', 'Prothrombin time normal', 'Red blood cell count decreased', 'Red cell distribution width normal', 'Respiratory failure', 'Sepsis', 'White blood cell count decreased']",1,PFIZER\BIONTECH,IM 1013000,TX,25.0,F,"On 2/7/21, had minor gnawing chest pain (2-3/10) which progressed to 7/10 chest pain , throbbing headache with positional changes and numbness down both arms (L>R). Went to the ER and was admitted.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/05/2021,02/07/2021,2.0,PVT,ElyRyng (Generic NuvaRing),None,None,,None,"['Chest pain', 'Computerised tomogram', 'Fibrin D dimer increased', 'Headache', 'Hypoaesthesia', 'Troponin increased', 'Ultrasound chest', 'Ultrasound scan normal', 'Vertigo positional']",2,MODERNA,IM 1013006,FL,69.0,F,"Patient complained of soreness in muscles morning after receiving the shot. She went about her day had a smoothie, spoke to people and also went for a walk came home and went into her jacuzzi tub and consequently passed away while in the tub. She was found by her husband at around 545pm, time of death is unknown and cause of death is currently pending.",Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/03/2021,1.0,OTH,"herbal medicines such as ginger, garlic, beetroot and a herbal reboot, No perceptions or over the counter drugs",no illness,High cholesterol,,No allergies,"['Death', 'Myalgia']",2,PFIZER\BIONTECH,IM 1013041,NY,85.0,M,Vaccine was administered on 1/15/2021 and death occurred on 1/31/2021.,Yes,01/31/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/31/2021,16.0,PHM,Unknown-Patient doesn't not regularly use our pharmacy,None,Heart failure,,Penicillin,['Death'],1,MODERNA,IM 1013048,CA,51.0,F,Patient was admitted to the Hospital with dx of a Pulmonary Embolus 2/9/21 Above named Hospital,Not Reported,,Not Reported,Yes,,Not Reported,N,01/27/2021,02/08/2021,12.0,PVT,Unknown,Unknown,Unknown,,NKMA,['Pulmonary embolism'],2,MODERNA,IM 1013051,MN,89.0,F,"On 2/6/21 at 6:00PM, resident experienced sudden left facial droop, left arm and left leg weakness. She was sent to hospital and they confirmed she had an acute ischemic stroke.",Not Reported,,Not Reported,Yes,,Yes,,01/24/2021,02/06/2021,13.0,SEN,"Aspirin 81mg, Citalopram 10mg, Furosemide 40mg, Insulin glargine, Losartan 50mg, Metoprolol 25mg, Vitamin B-12 1000mcg",,"Dementia, Congestive Heart Failure, Diabetes, Osteoarthritis",,No known allergies.,"['Facial paralysis', 'Hemiparesis', 'Ischaemic stroke']",1,MODERNA,IM 1013087,NY,69.0,M,Patient received vaccine on 1/23/2021 and death occurred on 1/30/2021.,Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/30/2021,7.0,PHM,Unknown-Patient does not regularly use our pharmacy,None,Heart problems,,Penicillin,['Death'],1,MODERNA,IM 1013095,HI,88.0,M,"Patient was technically a resident of retirement community, however, he chose to live independently at home at his current home. Only his spouse actually resides at retirement community. Patient received the second dose of the Moderna vaccine via pharmacy vaccination clinic at retirement community on 2/3/2021. He was found deceased in his home by a certified nursing assistant on 2/4/2021 at approximately 10:00am.",Yes,02/04/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,,,SEN,"See list below. Flomax 0.4 mg 1 Cap P.O. QD Tylenol 500mg 2 tabs PO PRN Carbidopa/levodopa 25-100mg PO 3 tab PO TID CoQ10 1 cap PO QD B12 1 tab PO QD Omega-3 Fatty Acids-Vitamin E 1,000mg 1 Cap PO QD Timolol 0.25% 1 gtt OU BID Finasterid",Unknown.,"See list below. Glaucoma, Hyperlipidemia, Inguinal Hernia, Hx-Gi bleed, Mandibular salivary gland removal- 2012, Hx-TIA, Hypertension, Lumbar disc disease, Parkinsonism, Pancreatitis history",,No known drug allergies,['Death'],2,MODERNA,SYR 1013102,NC,66.0,M,"The vaccine was given on 1/28/2021. The patient reported to the Medical Center ED on 2/7/2021 with complaints of worsening bilateral lower extremities pain, swelling, numbness L>R leg for about a week. He reports significant purple discoloration of his legs, ""purple spots on lower legs"", pain in bilateral legs worse with rest and standing still and associated DOE. Denied chest pain, abd pain, palpitations, fever, chills, NVDC, sick contacts, recent trauma/falls/injury. Denies regular use of NSAIDs, antiplatelet meds or chronic anticoagulation, clotting or bleeding disorders, history of DVT or PE. Patient was seen here by the ED staff on 2/3/2021 after a syncopal event at home where he described feeling light",Not Reported,,Not Reported,Yes,,Not Reported,N,01/28/2021,02/03/2021,6.0,PVT,"Epizicom, Lipitor, Sustiva, Synthrod",,Stage 4 squamous cell carcinoma (in remission) HIV Hypothyroidism Dyslipidemia Obesity,,Sulfa - rash,"['Activated partial thromboplastin time', 'Feeling abnormal', 'Hypoaesthesia', 'International normalised ratio', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Prothrombin time prolonged', 'Skin discolouration', 'Syncope']",1,PFIZER\BIONTECH,IM 1013120,MN,89.0,F,"On 1/27/21, resident experienced shortness of breath and felt some pressure on her chest. Systolic Blood Pressure was in the 200's and Diastolic Blood Pressure was in the 100's, HR 117. She was sent to Hospital and diagnosed with: St Elevation Myocardial Infarction due to occlusion of circumflex coronary artery, Acute Systolic Heart Failure, and Aspiration Pneumonia.",Not Reported,,Not Reported,Yes,9.0,Not Reported,,01/24/2021,01/27/2021,3.0,SEN,"Lantus Insulin, Novolog Insulin, Lisinopril 5mg",,"Diabetes Type 2, CKD 3, Hypertension, Insomnia, Degenerative Joint Disease, Neuropathy, Physical Deconditioning, Senile Cataract",,No known allergies,"['Acute left ventricular failure', 'Acute myocardial infarction', 'Chest discomfort', 'Coronary artery occlusion', 'Dyspnoea', 'Myocardial infarction', 'Pneumonia aspiration']",1,MODERNA,IM 1013140,AZ,40.0,M,"Patient presents to ED on 1/14/2021 with respiratory arrest and started around 1300. Per EMS, reportedly told fiance that he had taken some sleeping pills and was going to go to sleep. EMS was called after the patient was found unresponsive about 15 minutes later. Family attempted to do CPR. Upon EMS arrival to the patient's home, patient had a pulse, was in respiratory distress with agonal breathing. They also reported emesis in the airway. EMS performed nasal intubation and administered 10 mg IV Narcan en route. Upon arrival to the hospital, patient was moving arms more and gritting teeth. Patient had movements of decerebrate posturing of arms intermitting with a relaxed posture. GCS was 4 on arrival. Patient is currently still in ICU and has been extubated.",Not Reported,,Not Reported,Yes,26.0,Not Reported,Y,01/13/2021,01/14/2021,1.0,PVT,"Albuterol inhaler, zolpidem, quetiapine, doxepin, diazepam, advair diskus",,,,Peanuts,"['Bruxism', 'Coma scale', 'Coma scale abnormal', 'Decerebrate posture', 'Endotracheal intubation', 'Intensive care', 'Posturing', 'Respiration abnormal', 'Respiratory arrest', 'Respiratory distress', 'Resuscitation', 'SARS-CoV-2 test negative', 'Unresponsive to stimuli', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 1013145,FL,56.0,M,Patient texted a friend on 2/7/2021 c/o arm pain and feeling tired. I don't know if he was taken to a hospital. Autopsy today.,Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/08/2021,3.0,PUB,unknown,unknown,unknown,,unknown,"['Fatigue', 'Pain in extremity']",1,MODERNA,IM 1013169,KS,67.0,F,"Within 5 mins, pt notified staff she felt she was having a reaction. Pt c/o shortness of breath, chest pain, bilat leg numbness, no hives present, denied difficulty swallowing. Pt was brought to a room, placed on 02 10L by face mask. Initial BP 200/105 HR 116. Pt became non-verbal, PA-C dx'd stridor, epi 0.3mg was given deep IM to right thigh. Pt responded positively, within 2 mins, pt became alert and was able to respond to questions. EMS was contacted, arrived and took pt to hospital. She was unable to ambulate c/o of all over body numbness, racing HR. Pt was admitted for observation at Medical Center.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/03/2021,02/03/2021,0.0,PVT,"xanax 0.5mg TID prn, gabapentin 300mg BID, levothyroxine 25mcg daily, lexapro 10mg daily, tramadol 50mg q6 prn pain, trazodone 50mg HS",None noted,"Fibromyalgia, hyperlipidemia, insomnia, chronic pain, hypothyroidism, osteoarthritis",,"cefoxitin, codeine, dilaudid, lortab, mefoxin, meperidine, morphine, penicillins, savella, sulfa drugs","['Chest pain', 'Dyspnoea', 'Gait inability', 'Hypoaesthesia', 'Palpitations']",1,PFIZER\BIONTECH,IM 1013233,FL,66.0,F,"24 hours after second Pfizer dose, multiple Seizure activity occurred. Client was transported to the hospital for a 3 day stay. During that visit client was sedated and has little recall of hospitalization. Medication upon discharge - Keppra 750mg BID. First dose Pfizer 1/12/21 no reaction, not even sore arm",Not Reported,,Not Reported,Yes,3.0,Yes,U,02/02/2021,02/03/2021,1.0,PUB,HCTZ 25MG DAILY AMLODIPINE 5MG DAILY B COMPLEX OTC DAILY,CLL DX OCT 2020,CORNEAL IMPLANTS X 4,,CODEINE - NAUSEA MORPHINE - HALLUCINATIONS,"['Magnetic resonance imaging', 'Seizure']",2,PFIZER\BIONTECH,IM 1013235,TX,89.0,F,"Patient was transported to a local hospital, She experienced a stroke.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/06/2021,02/07/2021,1.0,PHM,"unknown, she doesn't usually fill medications here",heart conditions listed on intake form,heart conditions listed on intake form,,no known allergies,['Cerebrovascular accident'],2,MODERNA,IM 1013239,MI,78.0,F,"double vision, little dizzy, headache - yesterday had her 2nd vaccine SYMPTOMS DURATION: 2 days. Patient states she got her first COVID vaccine on 2/5/21 and had a slight headache but no other symptoms. Today, she was sitting the car when she started to have double vision. She reports dizziness/lightheadedness that is moderate. Patient states the double vision isn't everything but random things and at random times today. Denies dehydration, fever, or injection site abnormalities. No headache today. Reports that last week at her PCP's office her BP was slightly elevated and she thinks her BP may be elevated right now but does not have a cuff with her to check. Went to the Emergency Department on 2.6.21 - admitted overnight until the 7th. DETAILS OF HOSPITAL STAY: DX: Diplopia [H53.2] Blurred vision, bilateral [H53.8] HOSPITAL COURSE:� 1. Double�vision post COVID vaccine. Unclear etiology or if related to vaccine reaction. Resolved. CVA ruled out. Could be migraine associated. Advised patient to talk to PCP about migraine prophylaxis and see ophthalmology as outpatient. 2. HTN 3. HLD � Advised patient not to drive till cleared by ophthalmology Inpatient workup included myasthenia gravis panel which is still pending The patient is a 78-year-old right-handed woman who received her first Pfizer COVID vaccination February 5. This morning she developed double vision. Images were horizontal she does not know if they were binocular or monocular. She saw couple with 1 child and it appeared that they had 2 children. She looked at her son and saw 2 heads on 1 body. She saw 2 traffic lights. Each time she saw diplopia, it lasted for maybe 1 minute, and after blinking it went away. The double vision was not associated with headache, facial numbness or weakness, numbness or weakness in her extremities, speech change or imbalance. She recovered from each episode. She has had torn retina twice in each eye. Those were each associated with flashes of light in floaters. She did not have a fever today. She has never had double vision before. Review of systems: She admits to a history of headaches. She said she had catamenial headaches and sinus headaches.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/05/2021,02/06/2021,1.0,UNK,"albuterol, acetaminophen, amlodipine-benazepril, aspirin, atorvastatin, clobetasol, cyanocobalamin, esomeprazole, fexofenadine, fluticasone, fluticasone-salmeterol, montelukast, vitamin D3",,"asthma, hyperlipidemia, hypertension, degenerative arthritis, vitamin d deficiency, allergic rhinitis, GERD",,risedronate sodium (actonel); sulfa drugs; traMADol,"['Angiogram cerebral normal', 'Arteriogram carotid normal', 'Atrophy', 'Blood pressure increased', 'Cerebral small vessel ischaemic disease', 'Computerised tomogram head normal', 'Diplopia', 'Dizziness', 'Echocardiogram', 'Headache', 'Hyperlipidaemia', 'Hypertension', 'Magnetic resonance imaging brain abnormal', 'Migraine prophylaxis', 'Photopsia', 'Retinal tear', 'Scan with contrast', 'Sinus headache', 'Vision blurred']",1,PFIZER\BIONTECH,IM 1013249,NJ,50.0,F,"Stroke like symptoms like Loss of balance, loss of words, mixing up words, headache, nausea, distance in vision off, muscle aches",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/27/2021,01/31/2021,4.0,PVT,None,None,None,,Penicillin,"['Aphasia', 'Balance disorder', 'Blood glucose normal', 'Cardiovascular examination', 'Computerised tomogram normal', 'Disorganised speech', 'Echocardiogram normal', 'Electrocardiogram normal', 'Headache', 'Magnetic resonance imaging normal', 'Myalgia', 'Nausea', 'Neurological examination normal', 'Ultrasound Doppler', 'Ultrasound scan normal', 'Visual impairment']",1,MODERNA,SYR 1013264,MI,63.0,M,"First shot was 1/22/21, light headedness afterwords but no other. On Jan 27th blood pressure dropped so stopped high blood pressure meds. on 1/29 noticed blood pressure going up. Began meds with no effect. Has been going up to 198/112 during the week. Went into Hospital on 2/1. BP high, did blood work, ecg, released when BP dropped to 156/90. On 2/2 possible atrial fib and blood pressure up to 180/106, drove 280 miles to Clinic where they kept me overnight and did blood work, ecg, echocardio, xray and released me on 2/3 with double dosage of linisipril to 40 mg. Blood pressure did not go down and seemed to go up when I took the linisipril. 2/6 Drove back to clinic again and went into ED. BP 175/103, ecg switched bp meds to 50 mg Losartan and discharged. Drove home on 2/7. 2/8 blood pressure back up to 173/108 bpm 62 at 1:15 pm.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/22/2021,01/27/2021,5.0,PVT,"Lisinipril 20 mg, Atenolol 25mg, Loratadine 10 mg, fish oil 1000 mg, vit D 2000 mg,",,"high blood pressure, history of aortic aneurysm repair 1997 with homograft to replace stretched out valve, since then aortic valve replacement 2006, 2016",,"mustard, cat dander, dust mite","['Blood pressure decreased', 'Blood pressure increased', 'Blood test', 'Dizziness', 'Electrocardiogram', 'Hypertension', 'X-ray']",UNK,PFIZER\BIONTECH,IM 1013270,WI,77.0,F,"Pt developed Shingles after vaccination. Notes from call to PCP day after vaccination: ""Since yesterday morning after vaccine after she received her covid vaccine, she noted that her right ear hurts. She says that the pain does not feel like it is in the ear but right around the ear, and the bones around the ear. She says it hurts to chew, and the area to the back of her ear has ringing sound. She does not note that the ear is red . When she rubs under the ear she says the area is painful is painful. She does not note a lump or bump under her ear.. She states that the jaw/bone area hurts with the vibration of the conversation."" Sore throat and headache, only on right side. Pain progressed to the point of hospitalization, with vesicles erupting on right side of face/ear canal.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/02/2021,02/03/2021,1.0,PVT,"aspirin, carvedilol, clopidogrel, iron supplement, fluticasone nasal, furosemide, multivitamin, rosuvastatin, valsartan",,"right sided weakness, mild mitral and tricuspid insufficiency d/t valvular disease, hx of uterine cancer, asthma, history of STEMI, OSA, seasonal allergies, PVD, obesity, numbness of arm and legs (self reported on past patient questionnaire), HTN, hyperlipidemia, hiatus hernia, diverticulosis, DM type 2, CAD, CHF, hx CVA, carotid stenosis, cardiomyopathy of undetermined type, arthritis, anemia",,"Morphine (N&V), Fenofibrate, pravastatin (headaches), statins, ace inhibitors, furosemide, metformin (no sever allergic reactions to these meds reported)","['Erythema', 'External ear pain', 'Headache', 'Herpes zoster', 'Masticatory pain', 'Oropharyngeal pain', 'Pain', 'Pain in jaw', 'Rash', 'Rash vesicular', 'Tinnitus']",1,PFIZER\BIONTECH,IM 1013297,PR,77.0,M,"Patient was vaccinated at 11:30am. By 7pm he started presenting symptoms of fatigue, chest pain. Patient urinated and defecated in himself. Was not feeling well. Patient died at 10:30pm.",Yes,02/02/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,PVT,"Lovaza, Ibersantan, Flomax, Amaryl, Prednisolone, B-12 sublingual, Horse Chestnut Extract, Iron, Crestor, Xarelto, Triplix, Klonopin, Elavil, Folic Acid, Lantus, Tri Sleep, Elavil",NONE,DIABETES TYPE 2 POLIMIALGYA HIGH BLOOD PRESSURE HIGH CHOLESTEROL STENT PACE-MAKER,,NONE,"['Anal incontinence', 'Chest pain', 'Death', 'Fatigue', 'Malaise', 'Urinary incontinence']",2,PFIZER\BIONTECH,IM 1013341,FL,74.0,M,Patient had a syncope episode.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/08/2021,02/08/2021,0.0,OTH,None reported,None reported,None reported,,None reported,"['Electrocardiogram', 'Syncope']",1,PFIZER\BIONTECH,IM 1014470,NY,29.0,M,"No immediate side effects or symptoms following vaccination on January 20. January 31, 2021: large hive at site of injection, approximately 2-inches across and itchy. Followed by red rash, ""petechiae"" at site of injection. February 1, 2021: petechiae clusters appear on left and right arms, chest, and legs. Unexplained bruises appear on arms and legs. February 3, 2021: primary care doctor sends patient to emergency department. Emergency department runs a complete blood count, finding platelet levels at 23,000. Patient is admitted to Hospital overnight. February 4, 2021: patient begins five-day course of dexamethasone, 40mg/daily. Patient's platelet levels test at 63,000 15 hours after first dose of dexamethasone. February 5, 2021: patient is discharged from hospital. February 8, 2021: patient completes course of dexamethasone.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/20/2021,01/31/2021,11.0,PVT,None,None,None,,None,"['Contusion', 'Full blood count', 'Injection site erythema', 'Injection site haemorrhage', 'Injection site pruritus', 'Injection site rash', 'Injection site urticaria', 'Platelet count decreased']",1,MODERNA,IM 1014492,AR,86.0,F,"24 hours post event patient had vomiting and fevers. She was unable to walk to the ambulance and had to carried. Patient was admitted to hopsital and diagnosed with pneumonia on CXR. COVID PCR negative. CT did not show pneumonia and only showed bibasilar atalectasis. Pt's WBC was 37,000 on Day 2 of admission. This resolved with antibiotics. No source was found.",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,01/26/2021,01/27/2021,1.0,PVT,"1) albuterol CFC free 90 mcg/inh inhalation aerosol, 2 puffs q4h prn cough/shortness of breath 2) aspirin 81 mg oral tablet, One by mouth tablet daily 3) BP Cuff 4) Colace 100 mg oral capsule, One tablet PO BID 5) diazepam 2 mg oral tablet,",1/4/21 - COPD exacerbation and pneumonia. Lady Windemere syndrome.,"Past Medical History: HTN, vertigo, hyperlipidemia, hypothyroidism, lymphedema of L arm, ovarian and uterine cysts, SCC, basal cell, anemia of chronic disease, diverticulosis, cystocele, tricuspid and aortic regurg, osteoporosis, COPD mild, DDD lumbar spine, chronic UTI's.",,"sulfa drug (abdominal pain penicillin (anaphylaxis) doxycycline (abdominal pain) Cipro (hands itching) Myrbetriq (itching) tolterodine (itching) clindamycin (rash) amlodipine (headache, nausea) Fosamax (abdominal pain) Macrobid","['Aortic arteriosclerosis', 'Atelectasis', 'Biliary dilatation', 'Biliary obstruction', 'Bronchiectasis', 'Chest X-ray abnormal', 'Cholelithiasis', 'Computerised tomogram abdomen', 'Computerised tomogram thorax abnormal', 'Diverticulum intestinal', 'Gait inability', 'Hepatic cyst', 'Osteopenia', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test negative', 'Scan with contrast', 'Scan with contrast abnormal', 'Vomiting', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1014498,FL,49.0,F,"Patient had shortness of breath, stridor, chest pain 10 minutes after 2nd COVID-19 vaccine dose. Received epi-pen, nebulized bronchodilators, steroid injection, diphenhydramine and famotidine. Patient was in ER about 7 hours for observation, improved and was discharged home with supportive care.",Not Reported,,Yes,Not Reported,,Not Reported,U,02/08/2021,02/08/2021,0.0,PVT,"Advair inhaler, duloxetine 60mg, albuterol MDI",none,"Asthma, allergic rhinitis",,Allergic to bee stings,"['Chest pain', 'Dyspnoea', 'Stridor']",UNK,PFIZER\BIONTECH,IM 1014501,AL,76.0,F,"Pt received injection, then collapsed, with no memory of event. Pt was unresponsive approximately 15 seconds. HR 52 & irregular, BP 110/80",Not Reported,,Yes,Yes,1.0,Not Reported,U,02/08/2021,02/08/2021,0.0,PUB,unknown,none reported,"cardiomyopathy, has a pacemaker",,none,"['Chest X-ray', 'Full blood count', 'Memory impairment', 'Metabolic function test', 'Syncope', 'Troponin', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 1014508,,,F,Resident received second dose of C0VID -19 ON 2/2/21 on 2/3/21 resident had a fall after an episode of syncope,Not Reported,,Not Reported,Yes,,Not Reported,Y,02/02/2021,02/03/2021,1.0,UNK,,,,,,"['Fall', 'Syncope']",2,PFIZER\BIONTECH,IM 1014517,MA,82.0,F,3 d post vaccine hospitalized with orthostatic hypotension and vertigo 5 d post vaccine developed R face Bells Palsey,Not Reported,,Not Reported,Yes,2.0,Yes,N,01/22/2021,01/25/2021,3.0,PVT,baby aspirin 81mg daily,no,"Hypertension, hypercholesterolemia, heart disease, osteopenia",,"oxycodone, codeine- nausea and vomitting","['Dizziness', 'Facial paralysis', 'Nausea', 'Orthostatic hypotension', 'Pyrexia', 'SARS-CoV-2 test negative', 'Urinary tract infection', 'Urine analysis abnormal', 'Vertigo']",UNK,MODERNA, 1014530,FL,23.0,M,"facial numbness , weakness and facial drooping on Right side, bells palsy symptoms",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/01/2021,02/03/2021,2.0,OTH,None,none,none,,none,"['Facial paralysis', 'Facial paresis', 'Hypoaesthesia', 'Neurological symptom']",1,SANOFI PASTEUR,IM 1014532,WA,83.0,F,"1/28/21 5:35 p.m. extreme fatigue (useless), 1/29/21 Muscle pain in both upper arms all day, 1/30/21Intense joint pain in left hip continued 1/31 and 2/1 plus painful to walk, sit down and get up again, Unable to lead with (before vaccine) good left leg to go up stairs and now am unable to walk on my own because of the hip joint pain and must use a walker or furniture to get around. Muscle pain in upper left arm has continued and frequently in the upper right arm. I am scheduled for the second dose of Moderna Covid-19 vaccine and am concerned about having same.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/28/2021,01/28/2021,0.0,PVT,"Levothyroxine, Aspercreme w/Lidocaine, baby aspirin, Calcium w/D3, Omeprazole, Flaxseed oil, gabapentin. glucosamine/Chondroitin w/.MSM, Metformin, Metoprolol succinate ER, Multiple vitamins, Myrbetriq, Fluticasone Propionate nasal spray as",None,"Type 2 Diabetic, Neuropathic pain due to Chronic Lumbar Plexopathy, Back Pain since back surgery (have spine injection every 3 months",,"Topical Iodine, Allopurinol, Doxycycline, Morphine sensitive, Quinine, All Sulpha Antibiotics","['Arthralgia', 'Arthritis', 'Fatigue', 'Gait disturbance', 'Gait inability', 'Mobility decreased', 'Myalgia', 'Pain', 'Walking aid user', 'X-ray of pelvis and hip abnormal']",1,MODERNA,IM 1014559,AR,87.0,F,"Unsure if related to vaccine, but wanted to report event of death due to brain bleed on evening of administration of the vaccination.",Yes,02/04/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,PVT,Atenolol Plavix HCTZ MYAMBUTOL Omeprazole RAnexa Sertraline Simvastatin Rifampin ASA Nitroglycerin Latanoprost Imodium Fish oil MVI Combigan Vitamin D Butalbital,,CAD Migraine Hyperlipidemia,,Codeine Hydrocodone Hydroxyzine,"['Cerebral haemorrhage', 'Death']",1,PFIZER\BIONTECH,IM 1014590,LA,66.0,M,"Patient is a 66 y/o male with a PMH of adenocarcinoma of the colon s/p sigmoidectomy and colostomy, currently receiving chemotherapy, CKD3, single R. kidney, R. Hydronephrosis, pulmonary hypertension, presented to the ED from clinic due to weakness x 2weeks. Pt reports feeling weak and dizzy when he stands up, which improves with laying down. Denies any head trauma. Pt reports his BP usually ranges from 120-140 in clinic, but it has been consistently less than 120 for the past couple of weeks. Associated with brown colored urine, sometimes with a small amount of blood when initiating urination, general malaise, nausea, and vomiting a small amount of clear fluid every 2-3 days. Pt does endorse decreased PO intake for the past few months since starting this cycle of chemotherapy but is still able to keep food/water down. Pt denies recent changes in colostomy output, last changed yesterday. Denies fever/chils, urinary frequency/urgency, hematemesis. Assessment/Plan: * Sepsis - WBC 1.54, Hypotensive on admit - Likely 2/2 UTI - 1L IVFs in ED - Lactic Acid: wnl - BNP: wnl - CXR: Calcified granuloma left upper to midlung zone. Small nodular opacities questioned right upper lung zone and right midlung zone. Left subclavian Port-A-Cath again noted. - UA: 1.010, 2+ blood, 3+ leuks, 66 RBCs, >100 WBCs, many WBC clumps, 4 Hyaline casts - No urinary complaints on admit - Received an additional 30cc/kg of fluids - Day 3 of Neupogen - BCx pending - Continue broad spectrum abx (Vanc/ Zosyn), will de-escalate pending cx - Urine gram stain pending Anemia - H/H baseline 11-12 - H/H slowly dropping, today 8.8/26.5 - Denies any hematemesis, no bloody output in colostomy - s/p sigmoidectomy - Not symptomatic - Will continue to monitor - Transfuse if hemoglobin <7 or becomes symptomatic Hypotension due to hypovolemia See Sepsis Acute kidney injury superimposed on CKD - Patient presented with Serum Cr 3.5, with a baseline Serum Cr of 2.7 - Resolved. Serum Cr 2.2 today - Most likely due to sepsis - Gabapentin held at admit due to AKI superimposed on CKD3 1. Challenge with gentle IVF's 2. Maintain UOP at 0.5ml/kg/hr 3. Hold nephrotoxic medications 4. Renally dose current meds if applicable 5. Bladder scan if suspicion of retention, followed by retroperitoneal US to evaluate for hydronephrosis hydronephrosis. Foley if retention. 6. Avoid hypotension 7. Stricts I/O's 8. Monitor renal function closely Neutropenia - WBC on admit: 1.54 - Last chemotherapy 1/25 - ANC 494 today, down from 774 yesterday - Day 3 of Neupogen - See Sepsis NSTEMI (non-ST elevated myocardial infarction) - Troponin mildly elevated on admit: 0.052, repeat plateau will not trend - EKG on admit: NSR, no ST changes or evidence of ischemia present - Likely 2/2 sepsis, low concern for ACS - No CP on admit - Will hold off on initiating ACS protocol - Cardiac monitor Adenocarcinoma of colon metastatic to liver - History of Stage IIC (pT4bN0Mx) poorly differentiated adenocarcinoma of the colon in 2016 with recurrent disease in 2018 and 2020, now p T4b N2 Mx� - Followed by CMC Oncology - Last Oncology appt 1/26/2021: Received Irinotecan but leucovorin of Folfiri held - Will continue to monitor Neuropathy VTE Risk Mitigation (From admission, onward) Ordered heparin (porcine) injection 5,000 Units Every 8 hours 02/04/21 2026 IP VTE HIGH RISK PATIENT Once 02/04/21 2026 Place sequential compression device Until discontinued 02/04/21 2026 pt admitted for inpatient stay from ED on 2/4/2021 and discharged to home on 2/8/2021",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,02/03/2021,02/04/2021,1.0,PVT,allopurinoL 300 mg tablet TAKE 1 TABLET BY MOUTH ONCE DAILY FOR GOUT atorvastatin 40 mg tablet TAKE 1 TABLET BY MOUTH ONCE DAILY gabapentin 300 mg capsule TAKE 1 CAPSULE BY MOUTH THREE TIMES DAILY HYDROcodone 5 mg-acetaminophen 325 mg,body mass index 25-29 - overweight cachexia chronic kidney disease stage 3 colostomy present congestive heart failure constipation delay when starting to pass urine dizziness dysphagia dyspnea dysuria gout hyperlipidemia hypertensive disorder immunodeficiency secondary to chemotherapy immunosuppressive therapy impotence liver mass loss of appetite malignant tumor of colon muscle weakness opioid dependence overweight secondary malignant neoplasm of liver vascular disorder,body mass index 25-29 - overweight cachexia chronic kidney disease stage 3 colostomy present congestive heart failure constipation delay when starting to pass urine dizziness dysphagia dyspnea dysuria gout hyperlipidemia hypertensive disorder immunodeficiency secondary to chemotherapy immunosuppressive therapy impotence liver mass loss of appetite malignant tumor of colon muscle weakness opioid dependence overweight secondary malignant neoplasm of liver vascular disorder,,NKDA,"['Acute kidney injury', 'Acute myocardial infarction', 'Antineutrophil cytoplasmic antibody', 'Asthenia', 'Blood creatinine increased', 'Blood lactic acid', 'Blood test abnormal', 'Blood urine present', 'Brain natriuretic peptide normal', 'Cardiac monitoring', 'Chest X-ray abnormal', 'Chromaturia', 'Chronic kidney disease', 'Condition aggravated', 'Decreased appetite', 'Dizziness postural', 'Electrocardiogram normal', 'Gram stain', 'Haematocrit decreased', 'Haemoglobin decreased', 'Hypotension', 'Hypovolaemia', 'Lung opacity', 'Malaise', 'Metabolic function test normal', 'Nausea', 'Neutropenia', 'Neutrophil count decreased', 'Pulmonary granuloma', 'Red blood cell count increased', 'Red blood cells urine positive', 'Sepsis', 'Troponin increased', 'Urinary casts', 'Urinary tract infection', 'Urine analysis', 'Vomiting', 'White blood cell count decreased', 'White blood cell count increased', 'White blood cells urine positive']",1,MODERNA,IM 1014599,TX,53.0,F,"Throat started to close within 5 minutes of getting the injection. I also started to cough, itch, and had shortness of breath. Later on in the afternoon I got a severe headache that didn't go away until 4:00am. The next day my lips swelled up with blisters on my lips and my gums hurt a lot.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,PVT,"Rinvoq, methotrexate, turmeric, Ashwagandha, clove, astragalus, cinnamon, ginger.","Rheumatoid arthritis, fibromyalgia, insomnia, colitis, severe environmental allergies, asthma, back pain, nerve damage on lower left side of back, osteoarthritis.","Rheumatoid arthritis, fibromyalgia, insomnia, colitis, severe environmental allergies, asthma, back pain, nerve damage on lower left side of back, osteoarthritis, stiffness, inflammation and a lot of pain from the Rheumatoid arthritis.","Remicade was killing just about all my organs, Humira injectable caused major allergic reactions on my thigh when I gave myself ","azithromycin, clindamycin, bactrum, latex, avocado, bananas, celery, kiwi, plus other food sensitivities & food allergies like all dairy.","['Cough', 'Dyspnoea', 'Gingival pain', 'Headache', 'Immediate post-injection reaction', 'Lip blister', 'Lip swelling', 'Oral mucosal blistering', 'Oral pain', 'Pruritus', 'Throat tightness']",UNK,MODERNA, 1014628,MI,90.0,M,Death within 8 hours.,Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/03/2021,0.0,SEN,a long list,none,"melanoma, skin cancer",,,['Death'],1,MODERNA,SYR 1014658,AK,70.0,F,"Left MCA stroke, is currently in the CCU",Not Reported,,Yes,Yes,,Yes,N,01/15/2021,01/27/2021,12.0,PVT,,,"Serious heart condition, atrial fibrillation",,,"['Cerebrovascular accident', 'Intensive care']",1,PFIZER\BIONTECH,IM 1014659,FL,91.0,F,"Four days after being vaccinated, she developed pneumonia and died 8 days later.",Yes,01/26/2021,Not Reported,Yes,6.0,Not Reported,N,01/14/2021,01/18/2021,4.0,SEN,,,hypothyroidism,,none,"['Death', 'Pneumonia']",1,PFIZER\BIONTECH,UN 1014737,NV,63.0,F,"the day of the injection arm pain at injection site. Later at 1:00am I had body ache, muscle and joint pain and fatigue. On following day early in the evening I lost the ability total ability to speak. I had a severe stutter. I was rushed to the hospital via ambulance. I remained in the hospital and was released on Feb. 8",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/04/2021,02/05/2021,1.0,OTH,"Rapatha, Esomeprazole, vit. c, vit e, vit b-12, co-q 10, zinc, magnessium, vit d, probiotics, calcium, glucosomine, tumeric, Lutein, fish oil,",,"mitro valve prolapse, pre diabetic",,codine macrobid,"['Arthralgia', 'Blood test', 'Computerised tomogram head', 'Dysphemia', 'Echocardiogram', 'Fatigue', 'Injection site pain', 'Magnetic resonance imaging brain', 'Myalgia', 'Pain', 'Ultrasound thyroid']",UNK,MODERNA,SYR 1014740,CA,83.0,F,"Patient found down at home with agonal respirations and per EMS asystole, received 2 rounds of epi at her house with return of spontaneous pulses, lost pulse again in route to ER and another round of epi was given, CPR in progress when arrived at hospital. Prior to this patient's husband states he heard her fall in the bathroom but did not immediately check on her as he states that this has happened before. He checked on her 10 min later and that's when he found her unconscious. Daughter called 911 and she began CPR. No previous complaints of headache, chest pain, back pain, fever or chills. Husband states patient was drinking that evening which is not unusual for her. Patient died at hospital.",Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/06/2021,2.0,PVT,"Lisinopri, Sertraline, pravastatin, alendronate, Cetirizine, Vitamin D3,",no acute illnesses,"HTN, Cavernous hemangioma of liver, RBBB, hx of bilateral carotid bruits, hx of squamous cell carcinoma of right hand, arthralgia of both knees, spondylolisthesis at L3-L4, DDD thoracic, ovarian cyst, hx of pneumonia, cholelithiasis w/o obstruction, liver lesion, depression, hyperlipidemia, hypercalcemia, vitamin d deficiency, osteoporosis, former smoker, depression",,NKA,"['Agonal rhythm', 'Cardiac arrest', 'Death', 'Fall', 'Heart rate irregular', 'Loss of consciousness', 'Resuscitation']",1,MODERNA,IM 1014741,,82.0,F,"Pt admitted with ICH, likely secondary to increased ICP from nausea and vomiting after receiving her second pfizer covid vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,,02/02/2021,02/04/2021,2.0,UNK,,,,,,"['Cerebral haemorrhage', 'Intracranial pressure increased', 'Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH, 1014774,WA,71.0,M,"We were informed the patient passed away 2 days after receiving the vaccine. We do not have any details about what happened, we were informed by one of his employees. We have no knowledge that this had anything to do with the vaccination in any way.",Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/15/2021,2.0,PHM,Unknown,Unknown,None Reported,,None Reported,['Death'],1,MODERNA,IM 1014778,,64.0,M,"15 minutes after second dose of COVID 19 vaccine patient was brought to nurses due to lip swelling. Patient took personal liquid benadryl prior to nurses. Unsure of dose patient states took ""2 large swigs"". VS taken. 911 called by patient refuses ambulance dispatch. Patient denies need to go to hospital states already took own benadryl and they will not do anything else. VS monitored q 5 minutes by nursing. House supervisor called and down to speak with patient. Patient denies difficulty breathing. Continues to deny need for ambulance to hospital for assessment. Patient alert and oriented and carrying on conversation without difficulty. No further increase in lower lip swelling noted by nursing. Nursing noted some flushing to face, patient states he does that from time to time but does not notice it but coworkers will tell him he has flushing. No increase in lip swelling but states now feels some nasal congestion. Patient continues to deny difficulty breathing. Patient does states still does not feel ""quite right"". Patient encouraged by multiple nurses to allow 911 transport. After 15 minutes of monitoring patient now agreeable to be assessed by ER and 911 called. Patient did notify spouse by phone that he was going to requested hospital- hospital Patient continued to be monitored by multiple nursing staff until ambulance arrival and transport to hospital.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/04/2021,02/04/2021,0.0,PVT,,,,,,"['Feeling abnormal', 'Flushing', 'Lip swelling', 'Nasal congestion']",2,PFIZER\BIONTECH,IM 1014813,PA,62.0,F,"My right arm was painful at the injection site for 3 days after the vaccination. Then on Wednesday, February 3, 2021 about 3:45pm I experienced shortness of breath and some chest discomfort. At approximately 6:00pm, I felt a strong pulsating at my left temple which continued through the night. I took my blood pressure and it was 150/90 and pulse was 103 which is the highest reading I have ever had because I am on blood pressure medication. I took 2 aspirin, my Proventil Inhaler, and another Losartan 50 mg even though I had already taken my daily dose in the morning. I rested and continued to monitor my vitals. At about 11:30pm, I took my blood pressure and it was 160/110 and pulse was 109. I then took 2 more aspirin and my Clonazapem and fell asleep. In the morning on February 4, 2021, I tried to get in to see my doctor, but she advised to go to the emergency room. I went to an Urgent Care facility and the checked me and did an EKG and that was normal. But they also advised me to go to the emergency room. So I did go and they did another EKG, chest x-ray, and several blood tests. They came back normal but they wanted me to stay overnight for observation. On February 5, 2021 they did an echocardiogram and a stress test, which were normal. I was released from the hospital that afternoon. I have a follow up appointment with my Primary Care Physician on February 12, 2021. My blood pressure and pulse continue to be a little higher than normal. At this point, the pulsating, shortness of breath, and chest discomfort have improved. On Saturday, February 6, 2021, I noticed felt itchiness, redness and swelling at the injection site on my right arm. It is still itchy, red and swollen as of February 8, 2021. I am putting hydrocortisone cream on it.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/31/2021,02/03/2021,3.0,PHM,Pravastatin 10 mg Duloxetine 60 mg Clonazapem .5mg Allegra 180mg Losartan 50mg Proventil Inhaler Vitamins C & D Zinc Ibuprofen,None,Fibromyalgia Hypertension Elevated cholesterol,,Sulfa drugs,"['Blood pressure increased', 'Blood test', 'Cardiac stress test', 'Chest X-ray', 'Chest discomfort', 'Dyspnoea', 'Electrocardiogram', 'Headache', 'Heart rate increased', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Pain']",1,MODERNA,IM 1014865,IL,68.0,M,"He had not been feeling well after his second Covid vaccination (on 01/23/2021) and was found unresponsive in his room at the nursing home (late evening on 02/02/2021). He was taken to a hospital where they did tests and he had pneumonia and kidney failure, but he was being transferred to a larger hospital when he arrested and died (02/03/2021)",Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,01/23/2021,02/02/2021,10.0,SEN,,Tested positive for Covid in November,Muscular dystrophy,,,"['Cardiac arrest', 'Death', 'Malaise', 'Pneumonia', 'Renal failure', 'Unresponsive to stimuli']",UNK,MODERNA, 1014871,OK,50.0,F,"CENTRAL RETINAL VEIN OCCLUSION RESULTING IN LOSS OF SIGHT TO RIGHT EYE I WAS ON COMPUTER AND HAD BRIGHT FLASHES OF LIGHTS THE LOST VISION IN THE EYE ABOUT 2 1/2 HOURS AFTER RECIEVING VACCINE. CRVO IS RARE IN MY AGE WITH NO HEALTH PROBLEMS. SAW ER DOCTOR THAT NIGHT THEN OPTHAMOLOGIST THE NEXT MORNING WHO DIAGNOSED ME. I AM CURREENTLY PRESCRIBED A BABY ASPIRIN AND WILL HAVE TO GET INJECTIONS IN MY EYE WHEN MACULAR EDEMA OCCURS, AN EXPECTED OCCURRENCE WITH A BLOOD CLOT IN THE RETINAL VEIN",Not Reported,,Not Reported,Not Reported,,Yes,N,01/11/2021,01/11/2021,0.0,PUB,none,none,none,,sulfa,"['Angiogram retina', 'Blindness', 'Computerised tomogram head', 'Computerised tomogram thorax', 'Echocardiogram', 'Electrocardiogram', 'Laboratory test', 'Magnetic resonance imaging brain', 'Ophthalmological examination abnormal', 'Photopsia', 'Retinal vein occlusion', 'Visual acuity tests']",2,PFIZER\BIONTECH,IM 1015212,IL,27.0,F,Deep Venous Thrombosis of Right Axillary and Subclavian vein. Treated with IV Heparin Drip.,Not Reported,,Not Reported,Yes,,Not Reported,,01/30/2021,02/02/2021,3.0,WRK,Hormonal Intrauterine device,,,,,['Deep vein thrombosis'],2,PFIZER\BIONTECH,IM 1015253,ME,52.0,M,"Severe insomnia over the past 8 weeks, unrelenting. Start exactly at 24 to 48 hours after vaccine. Had no previous illnesses before that. No history of Covid infection. Has done all sorts of CBT modifications with no improvement. Was previously a super high functioning Interventional Cardiologist with no prior history of anxiety, depression or sleep problems. This was very acute and worsened after second dose. Labs are all normal. Now unable to work as this insomnia is quite debilitating.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/17/2020,12/18/2020,1.0,PVT,1. Lisinopril 5 mg QD 2. Lipitor 40 mg qhs 3. Vitamin D,None,1. HTN 2. Hyperlipidemia,,None,"['Asthenia', 'Blood testosterone', 'Blood thyroid stimulating hormone', 'Blood thyroid stimulating hormone normal', 'Condition aggravated', 'Full blood count', 'Impaired work ability', 'Insomnia', 'Metabolic function test', 'Vitamin D']",2,PFIZER\BIONTECH,IM 1015288,OK,39.0,F,Light red/pink round rash on upper arm near injection site with darker red/pink edges. Slightly itchy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,02/05/2021,10.0,PVT,amlodipine 10mg Daily spironolactone 100mg 2x a day cryselle 300mcg daily fiber gummy 5grams fiber 2x a day,,"Diabetic, controlled no medications High blood pressure",,Allergic to almonds,"['Injection site rash', 'Rash erythematous', 'Rash pruritic']",UNK,MODERNA, 1015292,CT,36.0,F,A rash developed around the injection site about 8 days following injection. The area was also hot to the touch and itchy. Lasted about 5days. Applied some hydrocortisone cream after 4 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/21/2021,8.0,PVT,,None,None,,None,"['Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,MODERNA,IM 1015295,CA,44.0,F,Events lasting approximately 48 hours (onset 18 hours after vaccine): Allodynia (whole body) Muscle aches (whole body) Debilitating headache Pain and swelling at injection site (right arm) Painful joints *Safe dose range of OTC Tylenol ineffective Ongoing effects (onset approximately 24 hours after first vaccine): Painful lump right breast/armpit,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/06/2021,1.0,PVT,Multivitamin with Iron Lexapro 20 mg every morning Prilosec 40 mg every morning,,Endometriosis,,"Phenergan (rash at injection site) Trazadone (dizziness, syncope)","['Allodynia', 'Arthralgia', 'Axillary mass', 'Axillary pain', 'Breast mass', 'Breast pain', 'Headache', 'Injection site pain', 'Injection site swelling', 'Pain']",2,PFIZER\BIONTECH,SYR 1015298,CA,74.0,F,"Dizzy, nauseous, pale, cold extremities, weak pulse. BP 90/44, HR - 44. O2 sat 96-99%. Blood sugar 127. Patient lay down, with feet elevated. Symptoms resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/05/2021,02/05/2021,0.0,UNK,,,,,,"['Blood pressure abnormal', 'Dizziness', 'Nausea', 'Pallor', 'Peripheral coldness', 'Pulse abnormal', 'Tachycardia']",1,MODERNA,IM 1015301,WA,51.0,F,"itchy swollen injection site, put ice on",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/31/2021,02/08/2021,8.0,PHM,,,,,,"['Injection site joint swelling', 'Injection site pruritus']",1,MODERNA,SYR 1015304,WA,43.0,F,"Redness, warm to touch, sensitive to touch",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/30/2021,02/08/2021,9.0,UNK,40 mg citalopram daily,No,,,No,"['Erythema', 'Sensitive skin', 'Skin warm']",UNK,MODERNA,SYR 1015310,NY,57.0,M,"Extreme soreness in upper left arm, painful to lift arm, approximately 10 hrs after I received the vaccine shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/08/2021,0.0,PVT,"Amlodipine 5mg, Atorvastatin 80mg",None,None,,None,"['Limb discomfort', 'Pain']",1,MODERNA,SYR 1015316,IN,40.0,F,I still hv swollen painful node above my collarbone..just been taking tylenol..no much relieve,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/09/2021,4.0,PVT,none,none,none,,None,['Lymph node pain'],2,MODERNA,IM 1015320,AK,77.0,F,"Severe all over muscle and joint ache, fatigue, dry cough, chills, dizziness and weakness. Began around 7 or 8 am February 5 and continued all day and evening. I slept most of the day. Around 11:30 that night I woke up feeling quite a bit better. I slept all night. The next morning, Saturday, the aches had gone away and I was alot better. The cough, however, continued. The cough continued through Sunday. Monday the cough happened only a few times and I felt energetic and completely back to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/05/2021,1.0,PVT,"Multi vitamin, omega 3, calcium, vitamin D, vitamin C, potassium, lutein, co enzymeQ10",None,Cyst on liver,,Codeine,"['Arthralgia', 'Asthenia', 'Chills', 'Cough', 'Dizziness', 'Fatigue', 'Myalgia']",2,PFIZER\BIONTECH,SYR 1015324,NY,62.0,F,"The day I received the shot, the site became red and warm to the touch and itchy with swelling. It calmed down in about 4 days. Then 7 days after the vaccine my injection site became very swollen, red, very hard in the injection area and itchy. I also felt slightly achy and had a headache for 3 days before that. Now 2 days later the reddened area is larger and circular like a target. Skin is warm to the touch and itchy. I?m no longer achy and no more headaches. The swelling in the left arm has decreased slightly but the redness is bigger.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/06/2021,7.0,PUB,"Pepcid, omega 3, multiple vitamin, vitamin C, echinacea, glucosamine",None,GERD,Mild pain and swelling at the site of a flu vaccine.,"Penicillin, aspirin and ibuprofen","['Headache', 'Injection site pruritus', 'Pain', 'Vaccination site erythema', 'Vaccination site induration', 'Vaccination site swelling', 'Vaccination site warmth']",UNK,MODERNA,IM 1015331,,59.0,F,"-On second day, began to develop low grade fever (up to 99.9), chills, and body aches. Tylenol helped somewhat. -On third day, became lethargic and extertional fatigue with shortness of breath symptomology and mild nausea; no fevers/chills on this day -On fourth day, mild diarrheal episodes (x 3, within 45 minutes), no abdominal pain/vomiting, but nausea persisted, in addition to worsening lethargy, and exertional fatigue with shortness of breath upon ambulation and climbing stairs - On fifth day, dry cough symptoms upon awakening for 1 hour, then continued lethargy and exertional fatigue with shortness of breath upon ambulation and climbing stairs, with somewhat improved nausea, oxygenation saturation 100%; by 9pm on fifth day, 30-40% improvement in symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/04/2021,02/05/2021,1.0,PVT,None,None,Seasonal allergies and eczema,,None,"['Chills', 'Cough', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Lethargy', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",2,MODERNA,IM 1015333,OR,36.0,F,"Fatigue, malaise, headache 24-48hrs after receiving Rash 2 inches below injection site formed at 72hrs, skin red, tender and warm to touch, elevated. Approx 3x5 inches in size.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/08/2021,3.0,PVT,"Probiotic, B6, vitamin d, magnesium, sodium naproxen, tyleonol",None,Celiac disease,,Gluten (celiac),"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site rash', 'Malaise', 'Skin warm']",2,MODERNA,SYR 1015336,OH,41.0,F,"Body aches, joint pains, fever, severe chills, muscle spasms, and fatigue began 12 hours post vaccination. Fever and chills lasted approximately 17 hours. Fatigue, body aches, joint pains last 4 days. Severe left TMJ pain began 31 hours post vaccination. Debilitating pain and muscle spasms continued. Chiropractor adjustment day 7. Family doctor consulted day 11 and started steroid and muscle relaxer. Dentist consulted day 14 and referred to physical therapist, recommended massage therapy and continued chiropractor care. Referral to oral surgeon if no improvement in 1 week.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,WRK,Levothyroxine 25mcg daily Spironolactone 50mg twice daily,None,Hypothyroid,,Nka,"['Arthralgia', 'Chills', 'Fatigue', 'Muscle spasms', 'Pain', 'Pyrexia', 'Temporomandibular joint syndrome']",2,MODERNA,IM 1015339,WA,37.0,F,"The normal side effects listed however , symptom started after completion of the Vase check in. Moderate nauseous and vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/08/2021,3.0,OTH,"Kratom 1 tsp 3 x a day ,amphetamine-dextroamphetamine 20 mgs, alprazolam 0.25mg , B12",Myelopathy associated with copper deficiency,Myelopathy associated with copper deficiency,,"Doxycycline, Tramadol Latex Codeine Ketorolac Tromethamine Chlorhexidine Gluconate Pork","['Nausea', 'Vomiting']",1,MODERNA, 1015342,CA,67.0,M,dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,OTH,None,None,None,,None,['Dizziness'],1,PFIZER\BIONTECH,IM 1015345,AR,74.0,M,Patient got the vaccine on 1/28/2021 . It just had a little fever where he got the vaccine and that went away in 3 days. Then 8 days later his thigh started turning red with fever and now it is a big red spot and fever.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/06/2021,9.0,PHM,"Metoprold E R Succinate 50 mg 1 in morning and 1 at night. Olmesartan Medoxomil 40 mg Finasteride 5 mg Terazosin 2 mg Ibuprofen, Benadryl, and Tylenol Arthritis",,,,Sulfa Drugs Penicillin,"['Erythema', 'Pyrexia']",1,MODERNA,IM 1015348,CA,69.0,M,"COVID arm - red rash around injection site; slight itchyness, hard and swollen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/08/2021,7.0,OTH,Tylenol,None,None,,None,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling']",UNK,MODERNA, 1015352,ID,45.0,F,"Tachycardia and Bright red Rash within 5-10 min of dose. Closing of throat, headache and blurred vision. EMS called. Epi pen and IM Benadryl. Severe arm pain with rash and blisters near injection site within 2 hours of injection.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/08/2021,02/08/2021,0.0,PUB,Lostartan Metformin ASA Zyrtec,None,BAV Pre diabetic,,Bee stings,"['Blister', 'Headache', 'Pain in extremity', 'Rash', 'Rash erythematous', 'Tachycardia', 'Throat tightness', 'Vision blurred']",2,MODERNA,IM 1015355,AZ,46.0,M,"The first dose of Pfizer vaccine was on 1/17/2021. I did not feel anything except a severe pain over my left arm only. But the second dose of this vaccine (on 2/7/2021) was different. In addition to the severe pain on my left arm, I had (and still) a severe headache, pains all over my body and bones, high fever (102), dizziness, shaking, fatigue, cold at all times, and a little bit taste loss (as of right now, 24 hours after the vaccine). It looks like a hard flu symptoms exactly.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/08/2021,1.0,OTH,"1- Metformin 750mg (1 tab at morning and 1 tab at evening 2 hours right before taking Pfizer vaccine at 11:30 pm) 2- Simvastatin 10mg (1 tab at evening only, 2 hours right before taking the vaccine)",None,Diabetes (type 2),Only severe pain on all of my left arm for 48 hours. That's it.,No any allergies,"['Ageusia', 'Bone pain', 'Dizziness', 'Fatigue', 'Feeling cold', 'Headache', 'Influenza like illness', 'Pain', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tremor']",2,PFIZER\BIONTECH,SYR 1015358,CA,67.0,F,"Hand tremor; BP 167/78; 156/78 (pulse 84, 78). Advised to f/u with PCP regarding high BP.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/06/2021,02/06/2021,0.0,UNK,,,,,,"['Blood pressure abnormal', 'Tremor']",1,PFIZER\BIONTECH,IM 1015361,TN,74.0,F,Arm red and has some swelling and warm to touch,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/08/2021,11.0,PUB,Folic acid800 Maxide 25mg Asprin 81mg Irbesartan 150 mg Liptor 20 mg calicum 1000,None,none,,ppencillin sulfa codeine,"['Erythema', 'Skin warm', 'Swelling']",1,MODERNA,SYR 1015363,CA,66.0,F,Developed lesion on left arm of injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,02/08/2021,13.0,OTH,"first dose of the Moderna COVID-19 vaccine on Jan. 26, 2021 i noticed a red lesion had formed around the injection site today February 8,2021. Very itchy",None,None,,Penicillin,['Injection site abscess'],1,MODERNA, 1015365,CO,36.0,F,"Chills, fever, body aches, diarrhea, nausea, temperature of 102.2, fatigue, sore arm with redness. Took Tylenol 8 hours into symptoms, majority of symptoms resolved within 24 hours. The redness and sore arm persists.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/07/2021,1.0,UNK,Vit D,None,None,,None,"['Chills', 'Diarrhoea', 'Erythema', 'Fatigue', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",2,MODERNA,SYR 1015368,,23.0,M,"Moderna COVID-19 Vaccine Moderate to severe chills, fatigue, myalgias, and headache. Moderate to severe tension like pulling in posterior neck and posterior head. NyQuil and Advil therapy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/05/2021,1.0,PUB,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Muscle tightness', 'Myalgia', 'Tension headache']",2,MODERNA,IM 1015372,CA,57.0,F,"Immediate tingling of LA/face/leg; BP 152/82 (pulse 94), BP 146/77 (pulse 102). Called 911.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/06/2021,02/06/2021,0.0,UNK,,,,,,"['Heart rate increased', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 1015375,CA,68.0,F,"02/05/2021 my upper left arm was itchy all day with mild swelling. 02/06/2021 when I awoke I noted a red circle in the same area, approximately 2-2 1/2"" in diameter. 02/07/2021 the redness is still present but not as red as yesterday. 02/08/2021 the redness is fading each day but still present.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,02/05/2021,8.0,OTH,"Multi-vitamin, Vitamin D3, Vitamin C",None,None,,Aspirin,"['Erythema', 'Peripheral swelling', 'Pruritus']",1,MODERNA,IM 1015465,KY,75.0,F,"DISCOVERED UNRESPONSIVE WITHOUT PULSE, RESPIRATIONS, HEART BEAT ON 2/7/21 AT 0435 A.M. RESIDENT WAS DNR STATUS.",Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,02/07/2021,17.0,SEN,"acetaminophen [OTC] tablet; 500 mg; amt: 500 MG; oral Special Instructions: 1 TABLET BY MOUTH EVERY 4 HOURS AS NEEDED As Needed PRN 1, PRN 2, PRN 3, PRN 4, PRN 5, PRN 6, PRN 7, PRN 8, PRN 9, PRN 10 03/14/2020- Open Ended Prescription Artifi","U07.1 2019-nCoV acute respiratory disease (Primary) N39.0 Urinary tract infection, site not specified (Admission) K21.9 Gastro-esophageal reflux disease without esophagitis G89.4 Chronic pain syndrome E66.01 Morbid (severe) obesity due to excess calories M54.2 Cervicalgia F41.9 Anxiety disorder, unspecified (History of) G47.00 Insomnia, unspecified E11.29 Type 2 diabetes mellitus with other diabetic kidney complication E03.9 Hypothyroidism, unspecified F06.30 Mood disorder due to known physiological condition, unspecified I50.22 Chronic systolic (congestive) heart failure I10 Essential (primary) hypertension M81.0 Age-related osteoporosis without current pathological fracture Z95.0 Presence of cardiac pacemaker F39 Unspecified mood [affective] disorder C85.84 Other specified types of non-Hodgkin lymphoma, lymph nodes of axilla and upper limb C82.94 Follicular lymphoma, unspecified, lymph nodes of axilla and upper limb F31.62 Bipolar disorder, current episode mixed, moderate K59.09 Other constipation Z45.2 Encounter for adjustment and management of vascular access device D64.9 Anemia, unspecified Z79.01 Long term (current) use of anticoagulants Z51.81 Encounter for therapeutic drug level monitoring M17.9 Osteoarthritis of knee, unspecified M15.0 Primary generalized (osteo)arthritis I87.2 Venous insufficiency (chronic) (peripheral) F31.9 Bipolar disorder, unspecified C85.89 Other specified types of non-Hodgkin lymphoma, extranodal and solid organ sites I73.9 Peripheral vascular disease, unspecified F32.9 Major depressive disorder, single episode, unspecified I89.0 Lymphedema, not elsewhere classified Q24.5 Malformation of coronary vessels I42.8 Other cardiomyopathies E03.9 Hypothyroidism, unspecified J30.9 Allergic rhinitis, unspecified Z86.718 Personal history of other venous thrombosis and embolism R33.9 Retention of urine, unspecified K42.9 Umbilical hernia without obstruction or gangrene Z90.89 Acquired absence of other organs R20.8 Other disturbances of skin sensation L03.111 Cellulitis of right axilla I87.2 Venous insufficiency (chronic) (peripheral) Z87.81 Personal history of (healed) traumatic fracture H04.121 Dry eye syndrome of right lacrimal gland R42 Dizziness and giddiness R53.81 Other malaise F48.2 Pseudobulbar affect R06.02 Shortness of breath H26.9 Unspecified cataract C85.80 Other specified types of non-Hodgkin lymphoma, unspecified site H53.2 Diplopia E11.51 Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene G89.4 Chronic pain syndrome E78.5 Hyperlipidemia, unspecified G47.33 Obstructive sleep apnea (adult) (pediatric) G60.8 Other hereditary and idiopathic neuropathies K57.92 Diverticulitis of intestine, part unspecified, without perforation or abscess without bleeding I48.91 Unspecified atrial fibrillation J02.9 Acute pharyngitis, unspecified (Preliminary) F31.63 Bipolar disorder, current episode mixed, severe, without psychotic features Z46.89 Encounter for fitting and adjustment of other specified devices R09.81 Nasal congestion Z46.89 Encounter for fitting and adjustment of other specified devices M25.562 Pain in left knee L53.9 Erythematous condition, unspecified R29.3 Abnormal posture F31.30 Bipolar disorder, current episode depressed, mild or moderate severity, unspecified T81.30XA Disruption of wound, unspecified, initial encounter R05 Cough (Preliminary) F31.64 Bipolar disorder, current episode mixed, severe, with psychotic features S28.222A Partial traumatic amputation of left breast, initial encounter Z48.3 Aftercare following surgery for neoplasm F31.64 Bipolar disorder, current episode mixed, severe, with psychotic features R41.841 Cognitive communication deficit N63.0 Unspecified lump in unspecified breast H25.012 Cortical age-related cataract, left eye (Preliminary) H25.011 Cortical age-related cataract, right eye (History of) H25.091 Other age-related incipient cataract, right eye Z23 Encounter for immunization Z74.1 Need for assistance with personal care M62.81 Muscle weakness (generalized) K59.00 Constipation, unspecified I49.9 Cardiac arrhythmia, unspecified E55.9 Vitamin D deficiency, unspecified (History of) L23.9 Allergic contact dermatitis, unspecified cause (History of) F33.8 Other recurrent depressive disorders (History of) Z11.1 Encounter for screening for respiratory tuberculosis D51.9 Vitamin B12 deficiency anemia, unspecified (History of) R13.11 Dysphagia, oral phase N18.31 Chronic kidney disease, stage 3a G44.021 Chronic cluster headache, intractable (Preliminary) C50.912 Malignant neoplasm of unspecified site of left female breast","U07.1 2019-nCoV acute respiratory disease (Primary) N39.0 Urinary tract infection, site not specified (Admission) K21.9 Gastro-esophageal reflux disease without esophagitis G89.4 Chronic pain syndrome E66.01 Morbid (severe) obesity due to excess calories M54.2 Cervicalgia F41.9 Anxiety disorder, unspecified (History of) G47.00 Insomnia, unspecified E11.29 Type 2 diabetes mellitus with other diabetic kidney complication E03.9 Hypothyroidism, unspecified F06.30 Mood disorder due to known physiological condition, unspecified I50.22 Chronic systolic (congestive) heart failure I10 Essential (primary) hypertension M81.0 Age-related osteoporosis without current pathological fracture Z95.0 Presence of cardiac pacemaker F39 Unspecified mood [affective] disorder C85.84 Other specified types of non-Hodgkin lymphoma, lymph nodes of axilla and upper limb C82.94 Follicular lymphoma, unspecified, lymph nodes of axilla and upper limb F31.62 Bipolar disorder, current episode mixed, moderate K59.09 Other constipation Z45.2 Encounter for adjustment and management of vascular access device D64.9 Anemia, unspecified Z79.01 Long term (current) use of anticoagulants Z51.81 Encounter for therapeutic drug level monitoring M17.9 Osteoarthritis of knee, unspecified M15.0 Primary generalized (osteo)arthritis I87.2 Venous insufficiency (chronic) (peripheral) F31.9 Bipolar disorder, unspecified C85.89 Other specified types of non-Hodgkin lymphoma, extranodal and solid organ sites I73.9 Peripheral vascular disease, unspecified F32.9 Major depressive disorder, single episode, unspecified I89.0 Lymphedema, not elsewhere classified Q24.5 Malformation of coronary vessels I42.8 Other cardiomyopathies E03.9 Hypothyroidism, unspecified J30.9 Allergic rhinitis, unspecified Z86.718 Personal history of other venous thrombosis and embolism R33.9 Retention of urine, unspecified K42.9 Umbilical hernia without obstruction or gangrene Z90.89 Acquired absence of other organs R20.8 Other disturbances of skin sensation L03.111 Cellulitis of right axilla I87.2 Venous insufficiency (chronic) (peripheral) Z87.81 Personal history of (healed) traumatic fracture H04.121 Dry eye syndrome of right lacrimal gland R42 Dizziness and giddiness R53.81 Other malaise F48.2 Pseudobulbar affect R06.02 Shortness of breath H26.9 Unspecified cataract C85.80 Other specified types of non-Hodgkin lymphoma, unspecified site H53.2 Diplopia E11.51 Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene G89.4 Chronic pain syndrome E78.5 Hyperlipidemia, unspecified G47.33 Obstructive sleep apnea (adult) (pediatric) G60.8 Other hereditary and idiopathic neuropathies K57.92 Diverticulitis of intestine, part unspecified, without perforation or abscess without bleeding I48.91 Unspecified atrial fibrillation J02.9 Acute pharyngitis, unspecified (Preliminary) F31.63 Bipolar disorder, current episode mixed, severe, without psychotic features Z46.89 Encounter for fitting and adjustment of other specified devices R09.81 Nasal congestion Z46.89 Encounter for fitting and adjustment of other specified devices M25.562 Pain in left knee L53.9 Erythematous condition, unspecified R29.3 Abnormal posture F31.30 Bipolar disorder, current episode depressed, mild or moderate severity, unspecified T81.30XA Disruption of wound, unspecified, initial encounter R05 Cough (Preliminary) F31.64 Bipolar disorder, current episode mixed, severe, with psychotic features S28.222A Partial traumatic amputation of left breast, initial encounter Z48.3 Aftercare following surgery for neoplasm F31.64 Bipolar disorder, current episode mixed, severe, with psychotic features R41.841 Cognitive communication deficit N63.0 Unspecified lump in unspecified breast H25.012 Cortical age-related cataract, left eye (Preliminary) H25.011 Cortical age-related cataract, right eye (History of) H25.091 Other age-related incipient cataract, right eye Z23 Encounter for immunization Z74.1 Need for assistance with personal care M62.81 Muscle weakness (generalized) K59.00 Constipation, unspecified I49.9 Cardiac arrhythmia, unspecified E55.9 Vitamin D deficiency, unspecified (History of) L23.9 Allergic contact dermatitis, unspecified cause (History of) F33.8 Other recurrent depressive disorders (History of) Z11.1 Encounter for screening for respiratory tuberculosis D51.9 Vitamin B12 deficiency anemia, unspecified (History of) R13.11 Dysphagia, oral phase N18.31 Chronic kidney disease, stage 3a G44.021 Chronic cluster headache, intractable (Preliminary) C50.912 Malignant neoplasm of unspecified site of left female breast",,"Iodinated Contrast- Oral and IV Dye, Penicillins (PCN)","['Heart rate abnormal', 'Pulse absent', 'Respiratory arrest', 'Unresponsive to stimuli']",2,MODERNA,SYR 1015628,,,F,"her mother died in her 70's following multiple injections of PNEUMOVAX23; This spontaneous report was received from the patient's daughter, referring to a 70 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) 0.5ml, once, every 5 years, for vaccination (strength, route, lot# and expiration date were not reported). On an unknown date, the patient died. The cause of death was not provided. It was unknown if an autopsy was performed. The causality assessment between death with pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not provided. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-2102USA001947:",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],UNK,MERCK & CO. INC., 1015630,CA,56.0,M,"Died of a heart attack; A spontaneous report was received from a consumer concerning a 56-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and died due to a heart attack. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included additional medications. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. - On an unknown date, the reporter stated the patient received Moderna's COVID-19 vaccine and sometime after he was found dead by his bedside around 02:30 am. The patient died on an unknown date. The cause of death was due to a heart attack. Plans for autopsy were not provided.; Reporter's Comments: This case concerns a 56 year old, male patient, who experienced fatal unexpected event of myocardial infarction. The event occurred on an unspecified date after mRNA-1273 (Lot# Unknown). Treatment details not provided. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.; Reported Cause(s) of Death: Unknown cause of death",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Death', 'Myocardial infarction']",1,MODERNA,OT 1015631,NY,,M,"Passed out; Hypotensive; Lightheaded; Heart rate dropped to 50; Arm soreness; A spontaneous report was received from a consumer concerning a 43-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced passed out, hypotensive, lightheaded, heart rate dropped to 50 and arm soreness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Jan 2021, approximately 0 days prior to the onset of the events, the patient received a dose of mRNA-1273 (Batch number 011L20A) intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, 6 minutes following vaccination, the patient experienced lightheadedness, became hypotensive, heart rate dropped to 50, and he passed out. Following the events, ambulance came and he was rushed to a health clinic. They gave him an Epinephrine shot and his vitals stabilized quickly. The patient also had arm soreness. Treatment for the event included epinephrine. Action taken with mRNA-1273 in response to the events was not reported. The events passed out, hypotensive, lightheaded, heart rate dropped to 50, were considered resolved on 23 Jan 2021. The outcome of the event arm soreness was unknown.; Reporter's Comments: Company comment: This spontaneous report concerns a 43-year old, male patient who experienced serious event of passed out and nonseries events of hypotensive, lightheaded, heart rate dropped to 50 and arm soreness. The events occurred on the same day, 6 minutes after the administration of the first dose of mRNA 1273 (lot number 011L20A, expiration date unknown). Treatment included epinephrine and outcome of all events except arm soreness are resolved. Based on the information provided, which indicates a temporal association of the reported events with the administration of mRNA-1273 vaccine, a causal association cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/23/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Dizziness', 'Heart rate decreased', 'Hypotension', 'Loss of consciousness', 'Pain in extremity']",1,MODERNA,OT 1015632,,,F,"Urinary retention; A spontaneous report was received from a female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed urinary retention. The patient's medical history was not provided. Concomitant product use was not provided. On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection. The patient reports that two days after receiving the vaccine, she developed urinary retention. Treatment for the event included cephalexin. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, urinary retention, was considered unknown.; Reporter's Comments: This case concerns a female patient, who experienced event of urinary retention. The event occurred 2 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No adverse event, Continue: [UNK], Comment: No medical history reported.",,,['Urinary retention'],UNK,MODERNA,OT 1015633,PA,,M,"Erythema multiforme; A spontaneous report was received from a physician concerning a 23-years-old male patient, who received Moderna's COVID-19 Vaccine, and who experienced erythema multiforme. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 13 Jan 2021, approximately ten days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 unknown lot number intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient started getting erythema multiforme. Treatment for the event included antihistamine and topical steroid cream. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event erythema multiforme was unknown.; Reporter's Comments: This case concerns a 23-years-old male patient, who experienced a serious unexpected event of erythema multiforme. This event occurred 11 days after first dose of mRNA-1273, lot # unknown. Treatment details was not provided. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/23/2021,10.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Erythema multiforme'],1,MODERNA,OT 1015634,IN,,M,"Heart attack; Short breath; Headache; Chills; A spontaneous report was received from a 37 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart attack, headache, chills, and short breath. There was no medical history provided. Concomitant medications included colecalciferol and metoprolol both for unknown indications. On 13 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Batch # 02L20A), in in his left arm, for prophylaxis of COVID-19 infection. On 14 Jan 2021, the day after vaccination, the patient experienced the non-serious events of headache, chills, arm pain, and short breath. On 19 Jan 2021, six days after receiving the vaccine, the patient experienced the serious event of heart attack. Treatment included paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events heart attack, headache, chills and short breath was unknown at the time of this report.; Reporter's Comments: This case concerns a 37-year-old, male patient. The patient's medical history was not provided. The patient experienced a serious, unexpected event of myocardial infarction 7days after the first dose of mRNA-1273 (Batch # 02L20A). The patient also had non serious event of headache, chills and dyspnea the day after the first dose of mRNA-1273 (Batch # 02L20A). Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/13/2021,01/14/2021,1.0,UNK,VITAMIN D [COLECALCIFEROL]; METOPROLOL,,Medical History/Concurrent Conditions: No adverse event (No adverse event was not reported),,,"['Chills', 'Dyspnoea', 'Headache', 'Myocardial infarction', 'Pain in extremity']",1,MODERNA,OT 1015635,OK,69.0,F,"Dehydration; Lost memory; Sore arm; Feels dizzy; Achy; Voice is hoarse; Fever; A spontaneous report was received from a consumer, who was a 69-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dehydration, fever, lost memory, sore arm, feels dizzy, achy, and voice is hoarse. The patient's medical history, as provided by the reporter, included some unspecified autoimmune issues. No concomitant product use was reported. On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient felt very dehydrated and ran a fever of 101.8 degrees Fahrenheit for which she took paracetamol. The patient reported she lost all memory from Friday, 22 Jan 2021. Her husband took her to the emergency room after not being able to hold anything down. She received two bags of intravenous fluids and was discharged home the following day on 23 Jan 2021. On 25 Jan 2021, the patient reported her arm was still sore, was dizzy and achy, and her voice was hoarse. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, dehydration, fever, and lost memory, was unknown. The events, sore arm, feels dizzy, achy, and voice is hoarse, were considered not resolved.; Reporter's Comments: This case concerns a 69 year old, female patient, with a medical history of unspecified autoimmune issues, who experienced serious unexpected event of dehydration and amnesia, non-serious unexpected event of pain in extremity, dizziness, pain, dysphonia and non-serious expected event of pyrexia. The event dehydration, amnesia and pyrexia occurred 2 days after mRNA-1273 (Lot# 030L20A), while the event of pain in extremity, dizziness, pain, dysphonia occurred on an unspecified date after mRNA-1273 (Lot# 030L20A). Treatment included Tylenol and IV fluids. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/21/2021,01/22/2021,1.0,UNK,,"Autoimmune disorder (""some autoimmune issues"".)",,,,"['Amnesia', 'Dehydration', 'Dizziness', 'Dysphonia', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,OT 1015637,NJ,84.0,F,"some bruising near my eye; area was a little tender; Afib started to act up; blacked out; Hit forehead on the door jamb; A spontaneous report was received from a consumer who was a 84-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced area was a little tender, Afib started to act up, blacked out, hit forehead on the door jamb and had some bruising near eye. The patient's medical history, as provided by the reporter, included atrial fibrillation with premature ventricular contractions (PVCs), and three cardioversions in the past 30 years. Concomitant medications reported included metoprolol, alprazolam, apixaban, amlodipine besylate, telmisartan, atorvastatin, ubidecarenone, multivitamin, vitamin B2, fish oil and cranberry extract. On 14 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 14 Jan 2021, after receiving the vaccine, the patient had no pain or soreness, but the area was a little tender if you pushed, and she waited one hour in the hospital afterwards. As the patient was getting ready to leave, she felt a little lightheaded. She was driven home, she ate lunch and then worked in the yard for a little bit. As she came inside, her Afib started to act up, she took an extra half of metoprolol, and had supper. She took half an alprazolam before going to bed. That night, as she got up to use the restroom, she had a strange feeling in her head like everything was going away. As she walked into the hallway, she blacked out and hit her forehead on the door jamb. Her forehead was all right but there was some bruising near her eye. She went back to bed and fell asleep. On 15 Jan 2021, when the patient woke up in the morning, her rate was still acting up. At about 9:30am to 10:00am, everything improved, and her heart felt normal. Everything seemed to resolve in approximately 25 hours. Treatment also included acetaminophen/diphenhydramine (no details when it was taken). She contacted her cardiologist since receiving the first dose of the vaccine. The cardiologist encouraged her to take the second dose of vaccine with diphenhydramine and have someone stay with her that night in case something happened again. Consent given for Safety to follow up. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, Afib started to act up, blacked out and hit forehead on the door jamb, were resolved on 15 Jan 2021. The outcome of the events, area was a little tender and had some bruising near eye, were not provided.; Reporter's Comments: This case concerns a 84 year old female patient with medical history including atrial fibrillation with premature ventricular contractions (PVCs), and three cardioversions in the past 30 years. Concomitant medications reported included metoprolol, alprazolam, apixaban, amlodipine besylate, telmisartan, atorvastatin, ubidecarenone, multivitamin, vitamin B2, fish oil and cranberry extract. She experienced serious unexpected events of Atrial fibrillation and Loss of consciousness and NS unexpected events of Contusion, Head injery and Vaccination site pain. The events occurred after first dose of the study medication administration after she went back home. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, her medical history of heart condition and medication she took could remain a confounder.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,UNK,METOPROLOL; XANAX; ELIQUIS; AMLODIPINE BESYLATE; TELMISARTAN; LIPITOR; COQ 10; CENTRUM SILVER +50; VITAMIN B2 [RIBOFLAVIN]; FISH OIL; CRANBERRY [VACCINIUM MACROCARPON],Atrial fibrillation; Premature ventricular contractions,Medical History/Concurrent Conditions: Cardioversion (Has had 3 cardioversions in the past 30 years),,,"['Atrial fibrillation', 'Condition aggravated', 'Contusion', 'Dizziness', 'Feeling abnormal', 'Head injury', 'Heart rate irregular', 'Injection site pain', 'Loss of consciousness']",1,MODERNA,OT 1015638,WA,64.0,F,"Deep vein thrombosis; pulmonary embolism; A spontaneous report was received from a 64-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed deep vein thrombosis and pulmonary emboli. The patient's medical history was not provided. Concomitant product use was not provided. On 05 Jan 2021, approximately 3 weeks prior to the onset of the events, the patient received first dose of mRNA-1273 (Lot number: 037K20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient reported she was hospitalized for deep vein thrombosis and pulmonary emboli. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, deep vein thrombosis and pulmonary emboli, were considered unknown.; Reporter's Comments: This case concerns a 64-year-old, female patient. The patient's medical history was not provided. The patient experienced serious, unexpected event of Deep vein thrombosis and pulmonary embolism. The events occurred 22 days after the first dose of mRNA-1273 (Lot number: 037K20A) administration. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested for further assessment.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/05/2021,01/26/2021,21.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Deep vein thrombosis', 'Pulmonary embolism']",1,MODERNA,OT 1015641,NC,51.0,F,"yesterday started a flare up but she is not sure if this is related to the vaccine use; fever/was 105.00 with Tylenol; increased dizziness/light-headed; body aches; severe headache; nausea; chills; sweating/sweats; Fatigue; feeling crappy; blood pressure tends to be low but was 95/81 at the time she got the shot; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 25Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration on 19Jan2021 17:45 at single dose on the left arm for COVID-19 immunization. Medical history included ongoing severe Crohn's disease, pneumonia, allergy to eggs/anaphylactic reactions to eggs, anaphylactic with bee stings on 2020 (this has happen twice in 2020), collapsed her lung (reaction to anesthesia that collapsed her lung), high fever, anaphylactic reactions. Concomitant medication included sertraline (SERTRALINE), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took Hep B and experienced fever, flu like symptoms, achy, and lethargic (no issue with the first 2 doses but with the 3rd dose she had a high fever); MMR and had an adverse reaction. It was reported that the shot was given on 19Jan2021. She experienced the following severe dizziness which started that day (17:45) and lasted 3 days. It has resolved. Nausea which started that day (17:45) and stayed constant for 3 days. Now it has only been happing in the late afternoons or evenings. Light headed which started that day and last 3 days. Headache (17:45), the initial headache felt like her whole head was going to explode into a 1000 piece. Now it just starts about 4-5pm in the evening. It was better and not as severe but like a migraine with nausea (17:45), feeling crappy (17:45), and body aches. Body aches which started on the day of the shot (17:45) and lasted 3 days. Fatigue which started on the day she got the shot (17:45) and was ongoing in the evening now chills and sweats which started on the day she got the shot and was ongoing. Her husband asked about if this was being related to the change of life but she doesn't think so. Fever which happened on the day she got the shot (17:45) but not at the site, later that night and was 105.00 with Tylenol. It has resolved. She noted that her blood pressure tends to be low but was 95/81 at the time she got the shot (17:45). The patient has not taken her blood pressure and does know if this has resolved. It was relayed that she took Tylenol and Benadryl before the shot due to her history and was still taking it as treatment for the symptoms. She has a lot of drug and other allergies, the only that was anaphylaxis was bees and egg. This was why she brought 2 EpiPens when she had the shot. She didn't have to use her EpiPen and was really proud of that but did have some reactions. The patient reported she did not go to the doctor. At this point she was somewhat expected that she had a not great reaction so the fact that she could still breath after getting it was a good thing. She also noted she could not have driven home due to dizziness. The patient was not brought to the emergency room and did not went to a physician's office. The patient has an ongoing medical history of Crohn's disease and reported that yesterday (as reported) started a flare up but she was not sure if this was related to the vaccine use. The patient recovered from fever on 23Jan2021; was recovering from dizziness, body aches, severe headache, nausea, chills, sweating, and fatigue; while outcome of blood pressure tends to be low, feeling crappy and Crohn's flare up was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,OTH,SERTRALINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE],Crohn's disease,Medical History/Concurrent Conditions: Anaphylactic reaction; Bee sting hypersensitivity (anaphylactic with bee stings and this has happen twice in 2020.); Egg allergy (allergy to eggs/anaphylactic reactions to eggs); Fever (102.0 fever); Lung disorder (reaction to anesthesia that collapsed her lung); Pneumonia,,,"['Abdominal pain', 'Chills', ""Crohn's disease"", 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Headache', 'Hyperhidrosis', 'Hypotension', 'Impaired driving ability', 'Migraine', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 1015642,SC,77.0,F,"diabetic; sugar level went to 66; shaking; dizziness; fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 77-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK9231), via an unspecified route of administration, on 23Jan2021 at 13:15, at single dose, for COVID-19 immunisation. Medical history included drug allergy (to epinephrine), diabetes, chronic obstructive pulmonary disease (COPD), arthritis. Patient did not have COVID-19 prior to vaccination. Concomitant medications included glipizide (unknown manufacturer), losartan (unknown manufacturer), lovastatin (unknown manufacturer), metformin hydrochloride (MEDFORMIN), meloxicam (unknown manufacturer). The patient experienced diabetic, sugar level went to 66, shaking, dizziness and fatigue all on 24Jan2021 at 11:00 with outcome of not recovered. The patient underwent lab tests and procedures which included blood glucose: 66 on 24Jan2021, 88 on 24Jan2021, 360 on 24Jan2021, 186 on 25Jan2021. On 24Jan2021 it was reported that sugar level went to 66. She ate sugar, level went to 88, ate more sugar level went to 360. Therapeutic measures were taken as a result of diabetic and sugar level went to 66 and included sugar. No therapeutic measures were taken as a result of the other events. Patient was not tested for COVID-19 post vaccination. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/24/2021,1.0,UNK,GLIPIZIDE; LOSARTAN; LOVASTATIN; MEDFORMIN; MELOXICAM,,Medical History/Concurrent Conditions: Arthritis; COPD; Diabetic; Drug allergy (To epinephrine),,,"['Blood glucose decreased', 'Blood glucose increased', 'Diabetes mellitus', 'Dizziness', 'Fatigue', 'Tremor']",1,PFIZER\BIONTECH, 1015643,,37.0,M,"Within 48 hours developed tachycardia. With heart rate reaching 136 at rest. Tachycardia is intermittent.; This is a spontaneous report from a contactable physician reporting for self. This 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3248) on 11Jan2021 05:30 PM (vaccine location=left arm) at single dose for COVID-19 immunisation. Medical history was none. No known allergies. Concomitant medication included apremilast (OTEZLA). No other vaccine in four weeks. It was reported that within 48 hours patient developed tachycardia. With heart rate reaching 136 at rest. Tachycardia was intermittent. Using propranolol currently to keep heart rate down, propranolol 10 mg, and titrated to 20 mg. The event resulted in Doctor or other healthcare professional office/clinic visit. Patient did not have COVID prior vaccination, and did not test COVID post vaccination. The outcome of event was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/01/2021,,PVT,OTEZLA,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Tachycardia'],1,PFIZER\BIONTECH, 1015644,IL,,F,"lost the taste and smell; lost the taste and smell; tested positive for the COVID-19 infection; tested positive for the COVID-19 infection; This is a Spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program . A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on 13Jan2021 for Covid-19 immunisation, as being a dental hygienist. The patient medical history and concomitant medications were not reported. on 15Jan2021 the patient lost the taste and smell and then in Jan2021 she was tested positive for the covid-19 infection. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive in Jan2021 tested positive for the COVID-19 infection. The outcome of events was unknown. Patient wanted to know if she should receive the second dose of the vaccine if she tested positive for the COVID-19 infection. She already consulted her physician and was instructed to receive the second dose. Patient wanted to know for how long would she be protected after receiving the second dose of the vaccine. Information on the Lot/Batch Number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/01/2021,,UNK,,,,,,"['Ageusia', 'Anosmia', 'COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1015645,AZ,,M,"muscle weakness; fever; oxygen level of less than 90; blurred vision; his legs are still kind of weak; his arm still aches on the left side where he got the shot; slurred speech; had no balance; frozen fingers; had no strength in his legs or arms; hallucinations; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. An 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm left in Jan2021 at single dose for COVID-19 immunization. The patient medical history included a minor hearing impairment from an unknown date and ongoing. The patient's concomitant medication included vitamin C from Jan2021 and ongoing. On 20Jan2021, the patient experienced hallucinations (the first day or two), slurred speech, he had had no balance, frozen fingers (2 fingers on each hand and his thumb), he had no strength in his legs or arms. On an unspecified date also experienced blurred vision, slurred speech, muscle weakness, fever, oxygen level of less than 90, his arm still aches on the left side where he got the shot. The patient outcome of hallucinations, slurred speech, frozen fingers was recovered, the outcome of he had no balance, he had no strength in his legs or arms was recovering, the outcome of his legs are still kind of weak and his arm still aches on the left side where he got the shot was not recovered, the outcome of the other events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/20/2021,19.0,MIL,VITAMIN C [ASCORBIC ACID],Hearing impaired (he has a minor hearing impairment),,,,"['Asthenia', 'Balance disorder', 'Dysarthria', 'Hallucination', 'Injection site pain', 'Muscular weakness', 'Musculoskeletal stiffness', 'Peripheral coldness', 'Pyrexia', 'Vision blurred']",1,PFIZER\BIONTECH, 1015646,GA,68.0,M,"shortness of breath/when he gets up to do anything it goes to 80; shortness of breath/when he gets up to do anything it goes to 80; feels uncomfortable; blood pressure was elevated along with his heart rate; blood pressure was elevated along with his heart rate; It was given in the upper left arm, he also has a little bruise that is still there now; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3302) via an unspecified route of administration on 19Jan2021 15:30 at single dose in the upper left arm for COVID-19 immunisation. Medical history included back disorder and is waiting for back surgery, high blood pressure, and very likely diabetic. There were no concomitant medications. The patient received the vaccine on Tuesday afternoon, didn't notice anything until Saturday. On Saturday afternoon (23Jan2021) he had a couple severe/serious episodes of shortness of breath. He has no other symptoms. It was better on Sunday and is better today but he still feels uncomfortable on Jan2021. He bought a oximeter today and while at rest he is at 94 but when he gets up to do anything it goes to 80. He doesn't know if this has anything to do with the vaccine but wants to know where the shortness of breath is coming from, if it is a side effect. The vaccine was administered on 19Jan2021. He has been very inactive and is waiting for back surgery that has been put off due COVID, the hospital delayed the surgery. He is very likely diabetic and takes one pill a day for this. He also has high blood pressure but is controlled and normal range is 120/70. It was elevated along with his heart rate (on Jan2021) with the bad breathing or shortness of breath episodes. He is trying to get surgical clearance and so he had an echocardiogram the Monday before the vaccine was given and a stress test on the Thursday prior to that. It was given in the upper left arm, he also has a little bruise that is still there now (Jan2021). It was given about 3:30pm. No treatment received. Event outcome of shortness of breath was not recovered, of others was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Back disorder (is waiting for back surgery); Blood pressure high (is controlled and normal range is 120/70); Diabetic (takes one pill a day for this),,,"['Blood pressure increased', 'Cardiac stress test', 'Condition aggravated', 'Discomfort', 'Dyspnoea', 'Echocardiogram', 'Feeling abnormal', 'Heart rate increased', 'Injection site bruising', 'Oxygen saturation decreased']",1,PFIZER\BIONTECH, 1015647,PA,68.0,F,"suspect polymyalgia rheumatica; bilateral proximal muscle stiffness; weakness/ could not support herself to walk around in her home; pain in her upper and lower extremities/ this bilateral upper and lower extremity pain; stiffness and weakness beginning at the shoulders and hips; dull headache; This is a spontaneous report from a contactable healthcare professional. A 68-year-old female (not pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 14Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), COPD (chronic obstructive pulmonary disease), previous TIA (Transient ischemic attack) with some residual right sided weakness, CHF (congestive heart failure), osteoarthritis. Had a childhood vaccination history. No Known allergies. Concomitant medications included albuterol, aspirin, atorvastatin, fluticasone, furosemide, hydralazine, ibuprofen, lisinopril, metoprolol, multivitamin, all above were in two weeks (as of 25Jan2021). The patient previously received influenza vaccine yearly, and received her pneumonia vaccines over the last several years, both for immunization and never had a reaction to a vaccine. The patient was not pregnant at time of vaccination. No other vaccine received in four weeks. The patient developed a dull headache on 15Jan2021, one date after the vaccine, but that it resolved after 24 hours on 16Jan2021. On 16Jan2021 at 8:00 AM, the patient developed bilateral proximal muscle stiffness, weakness, and pain in her upper and lower extremities over the course of 1 week. The patient started experiencing this bilateral upper and lower extremity pain, stiffness and weakness beginning at the shoulders and hips and extending distally over several days. Her symptoms started out relatively mild and progressively got worse over the course of 7 days. She presented to the reporting healthcare professional 8 days after her vaccination and she was extremely weak and could not support herself to walk around in her home, the reporting healthcare professional suspect polymyalgia rheumatica. All the events (except dull headache) resulted in emergency room/department or urgent care, hospitalization. The patient was hospitalization due to all the above events for 3 days. The patient had a remarkable response to the treatment of prednisone during her hospitalization. It was unknown if covid prior vaccination. The patient underwent lab tests and procedures, which included COVID tested (COVID test type: Nasal Swab, SARS-COVID19 PCR) post vaccination on 23Jan2021: Negative. Outcome of event headache was recovered on 16Jan2021 and all the events was recovered on an unspecified date. Information about lot/batch number was requested; Sender's Comments: A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded, considering the temporal relationship. However, it is worth noting that the 68-year-old female patient had pre-existing osteoarthritis, which could be one of the causes of joint symptoms. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/14/2021,01/15/2021,1.0,PHM,ALBUTEROL [SALBUTAMOL]; ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; FLUTICASONE; FUROSEMIDE; HYDRALAZINE; IBUPROFEN; LISINOPRIL; METOPROLOL,,Medical History/Concurrent Conditions: Congestive heart failure; COPD; Hypertension; Osteoarthritis; Transient ischemic attack (with some residual right sided weakness); Weakness left or right side,,,"['Asthenia', 'Condition aggravated', 'Gait inability', 'Headache', 'Joint stiffness', 'Mobility decreased', 'Musculoskeletal stiffness', 'Pain in extremity', 'Polymyalgia rheumatica', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,OT 1015648,TX,20.0,F,"mental fogginess; headache; body ache; 99.5 temp; swollen lymph nodes; sore jaw (from lymph nodes); swollen lymph nodes; sore jaw (from lymph nodes); swollen injection site; severe tiredness; muscle pain; muscle stiffness (neck and upper extremities); This is a spontaneous report from a contactable consumer (patient herself). A 20-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on the left arm on 25Jan2021 at 13:45 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. Relevant medical history included asthma and glucose intolerance; both from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included metformin and etonogestrel (NEXPLANON) for birth control. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in 4 weeks. The patient had no COVID-19 prior vaccination. On 25Jan2021 at 15:30, the patient experienced mental fogginess, headache, body ache, 99.5 temperature (temp), swollen lymph nodes; sore jaw (from lymph nodes), swollen injection site, severe tiredness, muscle pain, and muscle stiffness. The patient did not receive any treatment for the adverse events (AE). The patient was not tested for COVID-19 post vaccination (pending clarification). The patient was not recovered from all the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,PVT,METFORMIN; NEXPLANON,,Medical History/Concurrent Conditions: Asthma; Glucose intolerance,,,"['Body temperature increased', 'Fatigue', 'Feeling abnormal', 'Headache', 'Injection site swelling', 'Lymphadenopathy', 'Musculoskeletal stiffness', 'Myalgia', 'Pain', 'Pain in jaw']",1,PFIZER\BIONTECH, 1015649,IL,59.0,M,"Seem to have lapse in categorizing or focus on task; This is a spontaneous report from a contactable consumer (patient). This 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3248), via an unspecified route of administration on 14Jan2021 15:00 at single dose on the left arm for COVID-19 immunization. The patient medical history included COVID prior vaccination, high blood pressure and cholesterol. No known allergies. The patient's concomitant medications were not reported. Facility type vaccine was hospital. No other vaccine received in four weeks. The patient experienced seem to have lapse in categorizing or focus on task on 14Jan2021 16:00, reported as disability. AE resulted in Emergency room/department or urgent care, Disability or permanent damage. No COVID tested post vaccination. AE treatment included emergency room call and treatment to left hand. Outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/14/2021,01/14/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Blood cholesterol abnormal; Blood pressure high; COVID-19 (prior vaccination),,,"['Disability', 'Disturbance in attention']",1,PFIZER\BIONTECH, 1015650,AL,37.0,F,"1st dose: 01Jan2021/ 2nd dose: 25Jan2021; Angioedema and systemic anaphylaxis; Angioedema and systemic anaphylaxis; itchy face; Lips swollen; itchy mouth; tongue tingling; This is a spontaneous report from contactable Pharmacists. A 37-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN5318, Exp Date: 31May2021) intramuscular in right arm on 25Jan2021 15:45 at single dose for COVID-19 immunisation. She received the first dose on 01Jan2021 for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient is not pregnant. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient experienced angioedema and systemic anaphylaxis on 25Jan2021, events resulted in emergency room/department or urgent care. The signs and symptoms of the anaphylactic reaction were described as itchy face and mouth 20-30 minutes after the vaccination, lips swollen, tongue tingling. Patient was scared and crying. Her lips started to swell. The patient require medical intervention, the patient was seen in the emergency department. It was unknown if the patient hospitalized, the patient was not admitted to an Intensive Care Unit. It was unknown it the patient received treatment. The patient did not receive any recent vaccines for SARs-CoV2 other than Pfizer-BioNtech Covid-19 Vaccine prior to the event being reported. Events outcome was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/25/2021,0.0,UNK,,,,,,"['Anaphylactic reaction', 'Angioedema', 'Crying', 'Fear', 'Lip swelling', 'Oral pruritus', 'Paraesthesia oral', 'Pruritus']",2,PFIZER\BIONTECH,OT 1015651,WV,67.0,F,"Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unwell; Difficulty sleeping; Dizziness; Weakness; Joint pain neck; Joint pain neck; Mild injection site pain; This is a spontaneous report from a contactable nurse reporting for self. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history included Covid, Hypothyroidism, Arthritis, Chronic Neck R shoulder pain, Migraines, Submaxillary gland removal, Tubal ligation. Concomitant medication included amitriptyline, ibuprofen, levothyroxine sodium (LEVOTHYROXIN), ibuprofen (MOTRIN [IBUPROFEN]), vitamin d3. Patient received first dose of bnt162b2 on 30Dec2020 and experienced injection site pain. Patient had allergies to Amoxicillin, Duricef, Mobic, Nexium. The patient experienced severe chills, feeling unwell, difficulty sleeping, dizziness and weakness, passed out, laceration to back of skull requiring staples, joint pain neck, mild injection site pain, on 22Jan2021 01:00 AM, 24 hours later rash on torso. Patient underwent CT head neck, EKG, Chest XRAY, Labs, results all unknown. Events resulted in Emergency room/department or urgent care. Outcome of event rash was unknown, of other events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for passed out and chills. Laceration is subsequent to passed out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/22/2021,1.0,PVT,AMITRIPTYLINE; IBUPROFEN; LEVOTHYROXIN; MOTRIN [IBUPROFEN]; VITAMIN D3,,Medical History/Concurrent Conditions: Arthritis; COVID-19 (If COVID prior vaccination: Yes); Hypothyroidism; Migraine; Shoulder pain; Surgery; Tubal ligation,,,"['Arthralgia', 'Asthenia', 'Chest X-ray', 'Chills', 'Computerised tomogram head', 'Computerised tomogram neck', 'Condition aggravated', 'Dizziness', 'Electrocardiogram', 'Injection site pain', 'Insomnia', 'Laboratory test', 'Loss of consciousness', 'Malaise', 'Neck pain', 'Rash', 'Skin laceration', 'Suture insertion']",2,PFIZER\BIONTECH, 1015652,AL,42.0,F,"anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous report from contactable pharmacists and an other hcp and a nurse. A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) intramuscularly on 25Jan2021 15:15 in right deltoid at single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. Concomitant medications included high blood pressure medication. Patient was not able to breathe or talk. Her throat was closing up. They had to use epinephrine to help her breath. It was reported as anaphylactic reaction. The vaccine was administered at 15:15, patient was interacting with HCPs who asked basic questions and at some point (15:17) patient was not responsive, patient was not able to breath and talk. All events started from 25Jan2021 15:17. Patient was administered Epipen (also reported as Benadryl and Epinephrine) and ""she came back"". Patient was taken to hospital. Patient refused to call an ambulance. She was taken to hospital. The patient was not seen in the Emergency Department. The patient was not admitted to an Intensive Care Unit. No other vaccine in four weeks. No covid prior vaccination. Unknown if covid tested post vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient has not received any other vaccines around the time of bnt162b2 vaccination. The patient underwent lab tests and procedures, which included heart rate with result of went up as soon as epipen was administered, O2 saturation and vitals with unknown results, all on 25Jan2021. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylactic reaction with throat closing up and being unable to breathe or talk. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/25/2021,01/25/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Hypertension,,,"['Anaphylactic reaction', 'Aphasia', 'Dyspnoea', 'Heart rate increased', 'Throat tightness', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,OT 1015653,MD,65.0,F,"She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energy; Tired; Feeling sick; She was shaky, cold; She was shaky, cold; She had the flu; This is a spontaneous report from a contactable consumer reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1284), via an unspecified route of administration left arm single dose on 18Jan2021 17:30 for covid-19 immunisation. Medical history was none. There were no concomitant medications. No other vaccine was received in four weeks. The patient experienced passed out on 20Jan2021 14:00, tired on 18Jan2021 21:00, feeling sick on 18Jan2021 21:00, chills on 19Jan2021 09:00, aches on 19Jan2021 09:00, headache 19Jan2021 09:00, had no energy on 19Jan2021 09:00, lack of appetite on 22Jan2021 09:00, she was shaky in Jan2021, cold in Jan2021, she had the flu on Jan2021, she felt same the way but worst on an unspecified date. The outcome of the events was recovered on 22Jan2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/01/2021,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Chills', 'Decreased appetite', 'Fatigue', 'Feeling abnormal', 'Feeling cold', 'Headache', 'Influenza', 'Loss of consciousness', 'Malaise', 'Nervousness', 'Pain']",1,PFIZER\BIONTECH, 1015654,TX,71.0,F,"Hands shaking and looked like she has Parkinson's; Blood pressure was 183 over something, which is high for her; Felt heart palpitations and pressure in her chest; Felt heart palpitations and pressure in her chest; Facial flushing, redness; Facial flushing, redness; Lips swollen and numb; Lips swollen and numb; Left arm stiffness; This is a spontaneous report from a contactable consumer reported for self. This 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 12:30 on Arm left at single dose (lot number: EL8982) for Protection from COVID. Medical history included diabetes, slightly elevated blood pressure, taking drops under her tongue for her 21 environmental allergies, clarified product as sublingual immunotherapy, had a reaction to some kind of steroid shot recently. Had bad hives from it. Believes the steroid shot started with ""met."" And allergy to antibiotic. Concomitant drug included Sublingual immunotherapy, metformin at 500 mg and cetirizine hydrochloride (ZYRTEC). Past drug history included had Drug hypersensitivity to Neurontin, Detrol, Sulfur, and Neuropherntin. The patient experienced facial flushing, redness, and her lips felt like she had a Novocain shot on 22Jan2021. Her lips are still kind of numb. Can't feel her lips when she bites down on them. Believes reaction was fairly immediate. Sitting there for 15-20 min. Could feel a little facial flushing. Went home because (name withheld) is 45 minutes away from her house. By the time she got home was very flushed. Lips were getting more swollen and numb on 22Jan2021. Had an Epinephrine injection UPS Auto injector 0.3 mg, NDC: 49502 10201,Lot: 9FM783, Exp: Jun2021, Dose: injected one time in the middle of her right thigh and used it. Went to the ER. Had blood work and an EKG done. Was kept for five hours in ER. Had a chest x-ray. Blood pressure was 183 over something, which is high for her on 22Jan2021 that is controlled with medication. Experienced Hands shaking and looked like she has Parkinson's on 22Jan2021. Only lasted for a short time. Put on Prednisone for five days and told to see primary physician. Can't get into primary physician until Wednesday. Felt heart palpitations and pressure in her chest. Can't separate if it was the COVID-19 Vaccine or her nerves. She experienced Left arm stiffness on 22Jan2021. AEs require a visit to ER, was discharged from ER. Lab data on 22Jan2021 included Two sets of blood work separated by 3-4 hours: Unknown Results, Chest X-ray: Unknown Results, EKG: normal; on unknown date had a colonoscopy the day before the COVID-19 Vaccine: Unknown Results; Treatments were received for the events. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/22/2021,0.0,UNK,METFORMIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,"Medical History/Concurrent Conditions: Allergy to antibiotic; Blood pressure raised; Diabetes; Environmental allergy (Taking drops under her tongue for her 21 environmental allergies. Clarified product as Sublingual Immunotherapy.); Hives (Had a reaction to some kind of steroid shot recently. Had bad hives from it. Believes the steroid shot started with ""met."")",,,"['Blood test', 'Chest X-ray', 'Chest discomfort', 'Condition aggravated', 'Electrocardiogram normal', 'Erythema', 'Flushing', 'Hypertension', 'Hypoaesthesia oral', 'Lip swelling', 'Musculoskeletal stiffness', 'Nervousness', 'Palpitations', 'Tremor']",1,PFIZER\BIONTECH, 1015655,PA,62.0,F,"heart rate of 160; severe nausea; arm soreness; muscle soreness in left arm; general fatigue; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 21Jan2021 13:00 at single dose in left arm for COVID-19 immunisation. Patient age at time of vaccination was 62 years. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) administered on 30Dec2020 at 01:00PM and the patient said she did not have a reaction after the first vaccine. The patient received no concomitant medications. She stated that she had no other recent vaccinations or new medications. One thing that may be important is that she did do a 7 day detox that ended the Sunday before her second vaccine dose, so her body was pretty much having no impurities in it, and she has been eating clean since then, maybe having something foreign put into her body set it off after detox. The patient experienced arm soreness and general fatigue on 21Jan2021, and on 22Jan2021 at 01:00 she experienced severe nausea and heart rate of 160 (which was reported serious as medically significant). Patient reported that after her second dose of the COVID-19 vaccine she had a significant side effect that didn't happen until 10-12 hours after getting the vaccine. She did not have a reaction after the first vaccine. After the second injection her arm was sore, and she had general fatigue. She had the second dose injected Thursday at around 01:00PM, then at one in the morning her heart rate was 160, and she had severe nausea. She was that way until 08:00AM. Her heart rate was 120 probably by 09:00AM, then came down to 100, she has never had anything like that before. Her arm soreness was a deep muscle soreness to her left arm. The fatigue was a couple hours later after she got the second dose of the vaccine. The nausea started at 01:00AM, and lasted until six to eight, she did no treatment, and it improved and is still gone now. For her heart rate of 160, she had no treatment, though she probably should have gone to the hospital, but it came down. She usually runs a heart rate of 60-70, it went back to normal Friday, probably in the afternoon on the 22nd, about 12 hours after that started. The patient stated that she feels this is medically significant for her heart rate to be that high. She had contacted her primary care physician (PCP), but they didn't call her back for 4-5 hours, by then she was fine. She doesn't think that this was treated well by her PCP, and that they should have done an electrocardiogram (EKG) and follow up labs, she is changing her PCP as a result of this. She is concerned about the people who will be getting their second dose, she has been helping with these, they have patients that are over 100, they wouldn't survive that rapid heartbeat. The outcome of arm soreness/muscle soreness and fatigue was unknown.; Sender's Comments: The reported event of heart rate increased was likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Detoxification,,,"['Fatigue', 'Heart rate increased', 'Myalgia', 'Nausea', 'Pain in extremity']",2,PFIZER\BIONTECH, 1015656,AR,48.0,F,"Bilateral arm weakness/dysesthesia; Bilateral arm weakness; Severe fatigue; Pretty bad swelling in the shoulder joint that she had the shot in; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; stiffness in her neck and joints, and in both of her hands, fingers, and elbows; her neck and joints, and in both of her hands, fingers, and elbows; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; She also had pain in both biceps; Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope; This is a spontaneous report from a contactable Nurse. A 48-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 07Jan2021 at single dose via an unspecified route of administration in right deltoid for COVID-19 immunization. Relevant medical history included Multiple sclerosis/Diagnosed in 1991 or 1992. She also had 2 previous reactions to a pneumonia vaccine two years in a row. About 30-45 minutes after she had fainting episodes. On 07Jan2021 within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope. On the same day she complained pretty bad swelling in the shoulder joint that she had the shot in, along with stiffness in her neck and joints, and in both of her hands, fingers, and elbows. She also had pain in both biceps. On 08Jan2021 the patient experienced severe fatigue and 10Jan2021 Bilateral arm weakness/dysesthesia. They were floppy noodles and she could hardly use them. She could not hold her purse in her hands. She has not had this issue before with her Multiple Sclerosis. This took about a full week and a half for that to go away. It was like weakness/dysesthesia. She talked to her doctor and he said he felt like the shot had exacerbated her Multiple Sclerosis potentially. At the time of the reporting the patient was recovering from Bilateral arm weakness/dysesthesia. She recovered from fatigue on 09Jan2021, from 'Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope' on 10Jan2021and from other reported events on 12Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of bilateral arm weakness/dysesthesia cannot be excluded. The events are confounded by underlying multiple sclerosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,UNK,,Multiple sclerosis (Verbatim: Multiple sclerosis/Diagnosed in 1991 or 1992.),,,,"['Back pain', 'Condition aggravated', 'Dysaesthesia', 'Fatigue', 'Grip strength decreased', 'Injection site swelling', 'Joint stiffness', 'Mobility decreased', 'Multiple sclerosis', 'Muscular weakness', 'Musculoskeletal stiffness', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 1015657,NY,71.0,F,"I am having a feeling like I am in shock; I woke up last night not feeling right and this; Irregular heartbeat/Pulse 112/Pulse 108/went to 112; checked blood pressure, the lower number was high, upper number lower than what it usually is/130/96/then 110/78; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL3247) via an unspecified route of administration on 21Jan2021 10:00 am at single dose in left arm for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medication included ongoing atenolol for high blood pressure, ongoing amlodipine for high blood pressure, ongoing lisinopril for high blood pressure. The patient received the Pfizer COVID-19 vaccine at 10 am yesterday, her symptoms started last night and came on suddenly. She went and checked her blood pressure on 25Jan2021, the lower number was high, upper number lower than what it usually is, it was exactly: 130/96, Pulse 112, then 110/78 Pulse 108, after taking her medication. Her pulse went to 112, it does that when it gets irregular, it did get better after blood pressure medication atenolol. She woke up last night not feeling right and this morning, she was having a feeling like she was in shock. She developed an irregular heart beat last night on 25Jan2021. It is still bothering her. She had her first shot on Thursday of this past week. She is unsure if this is a side effect. Received the vaccine on 21Jan2021. She says it feels like it is right before you pass out. No treatment received. She is supposed to take blood pressure medication but she is being cautious right now. Her blood pressure medications are: Atenolol, Amlodipine, Lisinopril. She did not take them this morning, all have taken for years. Event outcome of irregular heartbeat was not recovered, while for others was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/25/2021,4.0,UNK,ATENOLOL; AMLODIPINE; LISINOPRIL,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Blood pressure abnormal', 'Dizziness', 'Feeling abnormal', 'Heart rate irregular']",1,PFIZER\BIONTECH, 1015658,IL,53.0,F,"her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that felt rapid; fatigue/tired; sluggish; nausea; she was not feeling well; Dry throat; injection site pain; This is a spontaneous report from a contactable consumer reporting for self. This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1280) on 24Jan2021 at 0.3 ml single by injection to left upper arm for COVID-19 immunisation (reported as works in assisted living). Medical history and concomitant medications were not reported. The patient received the vaccine on 24Jan2021, Sunday morning, then 6 hours after started feeling injection site pain, it was really sore, but she packed it with ice that night and it was very slight now. She worked the following morning (25Jan2021), and was sluggish, fatigue, and tired. Also nausea (started in the afternoon), it was slight, she was not feeling well. She experienced fibrillation in her heart, and that felt rapid, that comes and goes. Also dry throat on 25Jan2021, not sore, just dry. Her voice was still a little raspy, not like it was yesterday, she had a hard time speaking, when talk and dry throat. The outcome of injection site pain was recovering, sluggish, fatigue/tired, nausea was not recovered, outcome of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/24/2021,0.0,UNK,,,,,,"['Cardiac fibrillation', 'Dry throat', 'Dysphonia', 'Fatigue', 'Heart rate increased', 'Injection site pain', 'Malaise', 'Nausea', 'Sluggishness']",1,PFIZER\BIONTECH, 1015659,KY,25.0,M,"faint; Dizziness; tachycardia; BP sys: 160; HR 120+,; This is a spontaneous report from a contactable consumer (patient himself). A 25-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 22Jan2021 10:00 at single dose in left arm for COVID-19 immunization. The patient previously took diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) on an unspecified date for immunization and had had reaction to this vaccine with swelling of arm and surrounding lymph nodes. The patient had no other medical history was reported. The patient's concomitant medications were none. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient experienced dizziness, tachycardia, BP sys (systolic blood pressure): 160, HR 120+, and faint on 22Jan2021 10:30 and events result in Emergency room/department or urgent care. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,PVT,,,,,,"['Blood pressure systolic increased', 'Dizziness', 'Heart rate increased', 'Lymphadenopathy', 'Peripheral swelling', 'Syncope', 'Tachycardia']",1,PFIZER\BIONTECH, 1015660,IL,49.0,M,"swollen left calf that was DVT, deep vein thrombosis; This is a spontaneous report from a contactable Other Health Professional. A 49-year-old male patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248), via an unspecified route of administration on 11Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included hypothyroidism and high cholesterol. Patient had no known allergy. No COVID prior vaccination. No COVID tested post vaccination. Historical vaccine included 1st dose of bnt162b2 (lot: EK5730) via intramuscular on 23Dec2020 at 15:30 at single dose on left arm for COVID-19 immunisation. Concomitant medication included levothyroxine and atorvastatin. 1 week after receiving the 2nd dose, patient woke up with a swollen left calf. Ultrasound the same day (19Jan2021) showed that was DVT, deep vein thrombosis. Patient started taking apixaban (ELIQUIS) (blood thinner) the same day. Event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the event was resolving. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/19/2021,8.0,PUB,LEVOTHYROXINE; ATORVASTATIN,,Medical History/Concurrent Conditions: High cholesterol; Hypothyroidism,,,"['Deep vein thrombosis', 'Peripheral swelling', 'Ultrasound scan abnormal']",2,PFIZER\BIONTECH, 1015661,KY,,F,took 1st dose of Covid vaccine and then ended up in the hospital with fluid around her heart; took 1st dose of Covid vaccine and then ended up in the hospital with fluid around her heart which they said came out to be a virus; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program Pfizer First Connect. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)on 09Jan2021 at single dose for COVID-19 immunization. The patient medical history included lost her taste and had a low grade fever. Concomitant medications were not reported. This patient reported for a day and a half she lost her taste and had a low grade fever. So she went the next week (date unspecified) and was tested 2 times and came out negative (clarification of test type not provided). So on 09Jan2021 she got her first dose of the vaccine. On 14Jan2021 she ended up in the hospital with fluid on her heart which they said came out to be a virus. Outcome of the event was unknown.She was due for her second dose of the vaccine on 30Jan2021. Patient called to ask if she should or should not still get the second shot as scheduled. Information about batch/lot number has been requested.,Not Reported,,Not Reported,Yes,,Not Reported,U,01/09/2021,01/14/2021,5.0,UNK,,,Medical History/Concurrent Conditions: Low grade fever (for a day and a half); Taste loss (for a day and a half),,,"['Pericardial effusion', 'Viral infection']",1,PFIZER\BIONTECH, 1015662,VT,31.0,F,"black outs; Severe migraine; full body shakes; soured; delayed jumbled speech; loss of memory; nausea; motor control issues; This is a spontaneous report from a contactable consumer reported for herself. A 31-year-old female patient (not pregnant at the time of vaccination and event onset) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249, via an unspecified route of administration on 25Jan2021 10:00AM at single dose in right arm for covid-19 immunization, immunized in hospital. Medical history included obesity, anxiety, post-traumatic stress disorder (PTSD), insomnia, allergy to walnuts pecans. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonidine, fish oil and multi vitamin. The patient previously received the first dose of bnt162b2 lot number: EL1284, on 04Jan2021 12:00 PM at single dose in left arm for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously also received morphine and codeine, experienced allergy. The patient experienced sever migraine, black outs, full body shakes, soured, delayed jumbled speech, loss of memory, nausea and motor control issues, from 26Jan2021 11:30 PM. The events resulted in emergency room/department or urgent care. It was unknown if treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19. The case was reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,PVT,ZOLOFT; CLONIDINE; FISH OIL,,Medical History/Concurrent Conditions: Anxiety; Food allergy; Insomnia; Obesity; Post-traumatic stress disorder,,,"['Amnesia', 'Dysarthria', 'Dysgeusia', 'Loss of consciousness', 'Migraine', 'Motor dysfunction', 'Nausea', 'Speech disorder', 'Tremor']",2,PFIZER\BIONTECH, 1015663,WA,,F,"tested positive for covid-19; tested positive for covid-19; Dementia; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for her sister that a 73-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient had tested positive for the third time for the COVID virus. The patient had Dementia in Jan2021. The patient had first dose of BNT162B2 on 03Jan2021 and tested positive for COVID on 18Jan2021. Patient was scheduled for the second dose for Thursday 28Jan2021. Since patient had an active case with symptoms the reporter was assuming patient won't get the second dose on 28Jan2021. Since patient had already had the first dose, currently in quarantine until after 01Feb, the reporter wanted to know if patient would have to start all over with getting the vaccine. The patient underwent lab tests and procedures, which included COVID virus positive twice on an unknown date, positive once on 18Jan2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'Dementia', 'Quarantine', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1015664,,,M,"chest pain; This is a spontaneous report from a non-contactable Consumer. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 23Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced chest pain on 24Jan2021 . The patient was hospitalized for chest pain on an unknown date. No follow up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/23/2021,01/24/2021,1.0,UNK,,,,,,['Chest pain'],UNK,PFIZER\BIONTECH, 1015665,NY,60.0,F,"her face got swollen; lymph node right there it was extremely swollen and very tender and very painful; She had a lump at the site of the injection; chills; headache; flu like symptoms; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine , via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation . Medical history included hypertension. Concomitant medication included telmisartan (MICARDIS). On 30Dec2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced her face got swollen on an unspecified date with outcome of unknown , lymph node right there it was extremely swollen and very tender and very painful on an unspecified date with outcome of unknown , she had a lump at the site of the injection on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown , flu like symptoms on an unspecified date with outcome of unknown. The events swollen face and lymph adenopathy were considered important medical Events. The remaining events were considered non serious. The patient stated she got the second vaccine shot of Pfizer on Wednesday the 20Jan2021. She got like a weird side effect like under her armpit it got really swollen and painful, like the lymph node right there it was extremely swollen and very tender and very painful. It still is but not as much. The next day the right side of her face was swollen The patient received Tylenol as treatment for the events. Follow up information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,,,UNK,MICARDIS,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Axillary pain', 'Chills', 'Headache', 'Inappropriate schedule of product administration', 'Influenza like illness', 'Injection site mass', 'Lymphadenopathy', 'Swelling face', 'Tenderness']",2,PFIZER\BIONTECH, 1015666,GA,39.0,F,"patient was pregnant while taking BNT162B2; patient was pregnant while taking BNT162B2; Miscarriage 11 days post vaccine; This is a spontaneous report from a contactable Nurse. A 39-year-old female nurse reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0142), into the left arm on 28Dec2020 at 07:30 AM at single dose for COVID-19 immunization. Medical history included asthma and eosinophilic esophagitis and allergies to Keflex ASA. Concomitant drugs were none. At the time of vaccination the patient was pregnant, her last menstrual date was on 20Nov2020, gestational period 6. The patient reported that on 08Jan2021 at 12:00 PM she had miscarriage 11 days post vaccine. The patient was seen at Doctor or other healthcare professional office/clinic visit. At the time of reporting the patient was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported miscarriage. However, information is limited, and miscarriage is multifactorial event. In the general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15% to 20%. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/08/2021,11.0,WRK,,,Medical History/Concurrent Conditions: Asthma; Eosinophilic esophagitis,,,"['Abortion spontaneous', 'Exposure during pregnancy']",1,PFIZER\BIONTECH, 1015667,NY,30.0,F,"diarrhea (7+ loose stools each day starting on this day); headache; severe nausea; worsened muscle pain; new joint pain morning after (Included in aforementioned, but significant stiff neck.); new joint pain morning after (Included in aforementioned, but significant stiff neck.); fatigue/malaise; fatigue/malaise; This is a spontaneous report from a contactable other HCP report for self. This 30-year-old not pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) Intramuscular at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Asthma, anxiety, allergies to Acetaminophen (seizure like activity and fainting). No COVID prior vaccination. No other vaccine in four weeks. Other medications in two weeks includes fluoxetine, lorazepam, and Ibuprofen. Patient received first dose of bnt162b2 (lot number: EL0140) on 30Dec2020 and experienced injection sight tenderness, severe headache and fatigue. On 20Jan2021 5:00 PM after the second dose, patient experience headache, severe nausea, diarrhea (7+ loose stools each day starting on this day), worsened muscle pain several hours later, new joint pain morning after (Included in aforementioned, but significant stiff neck), fatigue/malaise. Patient received Ibuprofen and rest, supportive care due to events. The outcome of event was not recovered. Rapid Nasal Swab tested Negative on 21Jan2021.; Sender's Comments: The reported event diarrhea was likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship, and considering no alternative cause reported currently. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,SEN,FLUOXETINE; LORAZEPAM; IBUPROFEN,,Medical History/Concurrent Conditions: Anxiety; Asthma,,,"['Arthralgia', 'Diarrhoea', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Myalgia', 'Nausea', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,OT 1015668,NJ,73.0,F,"localized injection site reaction: redness, swollen and warm to the touch; localized injection site reaction: redness, swollen and warm to the touch; localized injection site reaction: redness, swollen and warm to the touch; This is a spontaneous report from a contactable nurse. A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 21Jan2021 at SINGLE DOSE vaccine location: left arm, dose number:1 for covid-19 immunisation. Medical history and concomitant medications were none. The patient experienced localized injection site reaction: redness, swollen and warm to the touch on 23Jan2021 with outcome of not recovered considered as important medical event. The physician recommended Tylenol and cold compress as treatment. The action taken was not applicable. Caller works in an assisted living facility. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported vaccination site events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/23/2021,2.0,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient's Medical History: none",,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,PFIZER\BIONTECH,OT 1015669,NJ,78.0,F,"swelling and significant bruise at injection site; swelling and significant bruise at injection site; This is a spontaneous report from two contactable nurses. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular into the left arm on 21Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were none. The patient developed swelling and a pretty significant bruise where the injection was given in her left arm. The caller noticed the bruise and swelling on 25Jan2021 but states it could be older. The events were reported as medically significant. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of vaccination site swelling and bruise cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Injection site bruising', 'Injection site swelling']",1,PFIZER\BIONTECH,OT 1015670,KY,85.0,F,"Xrays showed covid Poss pockets all in her lungs on 15Jan; Xrays showed covid Poss pockets all in her lungs on 15Jan; This is a spontaneous report from a contactable consumer. An 85-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included dementia. Concomitant medications were not reported. Patient popped hot 02Jan2021 along with 4 others on the hall she lived. Within 9 days 50+ patients were positive. All had the vaccine the same day. Patient was test positive on 02Jan2021. She was on day 12 of her quarantine when she started to get worse. She was unresponsive by 16Jan2021 and passed 18Jan2021. We were with her from 14Jan2021 to 18Jan2021. But had not been allowed to visit with her since Mar2020. And what post treatment pairs well with it? Publicly we hear Remdesivir and Bamlanivimab but these patients only received a general antibiotic and some vitamins. Death cause was Xrays showed covid Poss pockets all in her lungs on 15Jan2021. No autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information; Reported Cause(s) of Death: Xrays showed covid Poss pockets all in her lungs on 15Jan",Yes,01/18/2021,Yes,Not Reported,,Not Reported,N,12/29/2020,01/02/2021,4.0,SEN,,,Medical History/Concurrent Conditions: Dementia,,,"['COVID-19', 'Chest X-ray abnormal', 'Death', 'SARS-CoV-2 test positive', 'Unresponsive to stimuli']",UNK,PFIZER\BIONTECH, 1015671,KY,86.0,F,"bowel perforation; pain in her upper abdomen; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose on 13Jan2021 for Covid-19 immunisation, administerd at nursing home/senior living facility Medical history included dementia, arthritis. No known allergies. Patient was not pregnant. Patient had not COVID prior vaccination. Concomitant medication in 2 weeks included: memantine (manufacturer unknown) 10 mg BID, diclofenac (manufacturer unknown) BID, carbidopa, levodopa (manufacturer unknown) 25-100 mg TID, quetiapine (manufacturer unknown) 12.5 mg q HS, escitalopram oxalate (LEXAPRO) 10 mg q HS, paracetamol (TYLENOL) 650 mg BID, glucosamine (manufacturer unknown) drink. The patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 24Dec2020 for Covid-19 immunisation. No other vaccine received in 4 weeks. The patient experienced bowel perforation and pain in her upper abdomen on 18Jan2021 07:30. The events resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event), and death. On 18Jan2021 07:30 AM, less than a week after the second shot, she had pain in her upper abdomen and was taken to the ER on 18Jan2021. CT showed a bowel perforation in the small bowel. She had never had bowel surgery or diverticulitis. She had been healthy other than her dementia and arthritis. Patient received treatment for the events: hospice and pain management. COVID-19 was not tested post vaccination. The cause of death was bowel perforation. An autopsy was not performed. Information about lot/batch number has been requested.; Reported Cause(s) of Death: bowel perforation",Yes,01/20/2021,Yes,Not Reported,,Not Reported,N,01/13/2021,01/18/2021,5.0,SEN,MEMANTINE; DICLOFENAC; CARBIDOPA/LEVODOPA; QUETIAPINE; LEXAPRO; TYLENOL; GLUCOSAMINE,,Medical History/Concurrent Conditions: Arthritis; Dementia,,,"['Abdominal pain upper', 'Apparent life threatening event', 'Computerised tomogram abnormal', 'Computerised tomogram intestine', 'Death', 'Intestinal perforation']",2,PFIZER\BIONTECH, 1015672,MA,65.0,F,"my body collapsed and I had a Pulmonary embolism/I have clot in my lung; I have behind my knee like a deep wide black spot and it is hard; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medication included amlodipine, metformin and propranolol. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization and experienced severe headache and diarrhea. On 13Jan2021, the patient reported that: ""my body collapsed, I had a pulmonary embolism. I had to go to the hospital in ambulance. When I was there, they find out that I have clot in my lung. I was in an intensive care for 2 days or 3 days and about 5 days in the hospital (from 13Jan2021 to 17Jan2021). I have behind my knee like a deep wide black spot and it is hard, my body did not have anything like that"". Therapeutic measures were taken as a result of event pulmonary embolism/ clot in lung and included treatment with ""some medications"", one of which ELIQUIS. The patient outcome of pulmonary embolism and ""clot in lung"" was recovered on an unspecified date and of deep wide black spot was unknown. The information on the batch number has been requested.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/08/2021,01/13/2021,5.0,UNK,AMLODIPINE; METFORMIN; PROPRANOLOL,,,,,"['Diarrhoea', 'Headache', 'Induration', 'Intensive care', 'Pulmonary embolism', 'Syncope']",2,PFIZER\BIONTECH, 1015673,NC,71.0,M,"Confusion; General ""Don't feel right""; Seizure; Low Sodium level; This is a spontaneous report from a contactable consumer (reported for himself). A 71-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), via an unspecified route of administration on 27Jan2021 11:15 at single dose in left arm for COVID-19 immunization. Medical history included High Cholesterol; No known allergies. Concomitant medication in two weeks included atorvastatin. Facility type vaccine was Hospital. No other vaccine in four weeks. On 30Jan2021 23:00, the patient experienced Seizure, Low Sodium level, Confusion, General ""Don't feel right"". The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The number of days hospitalization was 3 (from unspecified date in 2021 to an unspecified date in 2021). It was unknown if treatment received. No covid prior vaccination. Covid tested post vaccination: Nasal Swab tested on 01Feb2021 with the result of Negative. The outcome of the events was recovered on an unspecified date in 2021.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,01/27/2021,01/30/2021,3.0,PVT,ATORVASTATIN,,Medical History/Concurrent Conditions: High cholesterol,,,"['Blood sodium decreased', 'Confusional state', 'Feeling abnormal', 'SARS-CoV-2 test negative', 'Seizure']",1,PFIZER\BIONTECH, 1015674,FL,71.0,F,"She confirms the rash started after receiving the covid vaccine/terrible rash is up and down both arms, the crown of her head, and on her scalp; Pfizer covid vaccine: nausea; Pfizer covid vaccine: chills; Pfizer covid vaccine: hurting at the injection site; Pfizer covid vaccine: headaches/on and off headaches; She cannot speak this morning; Pfizer covid vaccine: vomiting; This is a spontaneous report from a contactable Nurse (patient). A 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL8982, expiry date: 31May2021) intramuscular injection in right upper arm on 19Jan2021 10:00 at single dose for COVID-19 immunisation. Her second dose is scheduled on 10Feb2021. Medical history included stage 4 metastatic breast cancer. There were no concomitant medications. The patient previously took Ibrance for stage 4 metastatic breast cancer and experienced broken out in terrible rash. She is taking Ibrance for cancer, she has been taking it for a while. The past few weeks she has broken out in terrible rash. She went to a dermatologist that stated the rash was from Ibrance. She cannot speak this morning (Jan2021). Her doctors are speaking to each other and she is being told not take Ibrance by the dermatologist and to continue taking from her oncologist. Reports she had a pathology report and it showed her skin eruptions she is having is from Ibrance. She clarifies that her terrible rash is up and down both arms, the crown of her head, and on her scalp. She took the first dose of the COVID-19 vaccine a couple of weeks ago. She is having quite a bunch of side effects from the injection. The side effects she is experiencing after the COVID vaccine are nausea, vomiting, chills, hurting at the injection site which is not terrible, and on and off headaches. Events did not require a visit to emergency room or physician office. Nausea started 3 days after the receiving the vaccine on 22Jan2021. Vomiting is still ongoing on and off and started about a week and half after receiving the vaccine (Jan2021). Chills started right away and she still has the chills. It has not changed. The chills started maybe a day after receiving the vaccine (20Jan2021). Hurting at the injection site started the day after (20Jan2021) and lasted for two or three days and is still ongoing, reports it goes on and off. Reports the hurting at the injection site is not terrible. Headaches started a day or so after receiving the vaccine (20Jan2021) and is still ongoing, on and off. Reporter seriousness for events nausea, vomiting, chills, hurting at the injection site, headaches were reported as medically significant. She is currently taking Ibrance since her oncologist told her not to stop taking Ibrance. The dermatologist said her rash is related to Ibrance. When querying causality she reported that she is not sure because she has been taking Ibrance for a while. She confirms the rash started after receiving the COVID vaccine. Events outcome of nausea, vomiting, chills, hurting at the injection site, headaches was not recovered (nausea and vomiting was reported as worsened), while for others was unknown. Relatedness of drug Pfizer COVID vaccine to events for nausea, vomiting, chills, hurting at the injection site, headaches were reported as related.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/01/2021,,PVT,,,Medical History/Concurrent Conditions: Metastatic breast cancer,,,"['Aphasia', 'Aphonia', 'Chills', 'Headache', 'Injection site pain', 'Nausea', 'Pathology test', 'Rash', 'Vomiting']",1,PFIZER\BIONTECH,OT 1015675,AR,91.0,M,"I faint anf fell twice hurt my back once; I faint anf fell twice hurt my back once; hurt my back once; Dizzy spells; Constipation; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration in Jan2021 (a week before reporting) at single dose in left shoulder for COVID-19 immunisation. Age at vaccination was 91 years. The patient's medical history and concomitant medications were not reported. About 24 hours after shot he started having some dizzy spells and then fainted and fell a couple of times and hurt his back once. He stated he also had had constipation since the shot and do not know if that is related or not. The patient wanted to talk to see if he could get his second shot. He is taking some pain killers for his back. With regards to Physician Office/ Emergency Room: patient stated, 'This for my back and nothing else of that'. The outcome of the events was unknown. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['Back injury', 'Constipation', 'Dizziness', 'Fall', 'Syncope']",1,PFIZER\BIONTECH, 1015676,FL,,M,"tongue is a lot swollen; Dizziness; Nausea; feeling weak; tired and washed out; swollen glands; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient was experiencing dizziness and right after the vaccine had dizziness and nausea. She said that the nausea went away after eating something. She said that he also feels like his tongue was swollen. The patient said that he feels like his tongue is a lot swollen. He stated that he had the shot 4 hours and when he gets up off of the chair, he can barely stand up because he is so dizzy. He said that he is also feeling weak, tired, and washed out. He said that he also has swollen glands. The event tongue is a lot swollen was serious as Life threatening, and Emergency Room Visit and Physician Office Visit. The outcome was unknown. Information on the Batch/Lot number has been requested.",Not Reported,,Yes,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Asthenia', 'Balance disorder', 'Dizziness', 'Fatigue', 'Lymphadenopathy', 'Nausea', 'Swollen tongue']",UNK,PFIZER\BIONTECH, 1015687,OH,62.0,M,"Almost immediate headache per wife. Developed fever around 4 pm. Headache all day. Took Tylenol at 4 and 10 pm. Gradual development of SOB and cough. Temp of 101.4 at 10 pm. pulse ox 92% at 10 pm. Went to sleep, woke up at 0050 with increasing SOB. Pulse ox 82%. Used albuterol inhaler, wife called emergency services at 0113. EMS arrived around 0130 to patient's home. pulse ox 86%, coughing, sob, hard time breathing. Walked to stretcher. Became unresponsive. Found to have no pulse, stopped breathing. CPR initiated at about 0140. King airway placed in field, I/O in left tibia. Patient from PEA to asystole, to vfib, to asystole. ACLS followed. Unrecoverable asystole and patient time of death 0213.",Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/08/2021,0.0,PVT,"lipitor, pepcid, uloric, prozac, synthroid, lisinopril, troprol xl, multivitamin, niacin, nifedical xl, ranexa, demadex, xarelto",none,"a fib, HTN, CAD, PTSD, CHF, anxiety, gout, reflux, high cholesterol, obese, hypothyroidism.",,nknda or food allergies,"['Body temperature increased', 'Cardiac arrest', 'Cough', 'Death', 'Dyspnoea', 'Headache', 'Intraosseous access placement', 'Laryngeal mask airway insertion', 'Oxygen saturation decreased', 'Pulse absent', 'Pulseless electrical activity', 'Pyrexia', 'Respiratory arrest', 'Resuscitation', 'Unresponsive to stimuli', 'Ventricular fibrillation']",2,MODERNA,IM 1015692,IN,82.0,M,Patient received first dose of Moderna vaccine 1/27/21 and presented to urgent care 2/8/21 with complaint of sores on inside of lower lip. Patient reported that sores started on 2/5/21 and seem to be growing in size. Patient did not recall any injury and sees dentist regularly for annual cleaning. Patient also does not smoke or chew tobacco. Patient was referred to his dentist who was able to get patient in and felt that lesions and ulcerations were not infectious or cancerous. The NP ordered lab work and recommend patient follow up with PCP. Labs came back two hours later and showed patient had a platelet count of 1 (THOUS/uL). Patient was sent to ER at Hospital 1 and was transferred to Hospital 2 for a hematology work-up. Patient is currently admitted and receiving IVIG and steroids,Not Reported,,Not Reported,Yes,2.0,Not Reported,,01/27/2021,02/05/2021,9.0,PUB,Aspirin 81mg daily Levothyroxine 50 mcg daily Multi-vitamin daily,None,Hypothyroidism,,Latex allergy,"['Cheilitis', 'Haematocrit normal', 'Haemoglobin normal', 'Immunoglobulin therapy', 'Lip ulceration', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Platelet count decreased', 'Red blood cell count normal', 'White blood cell count normal']",1,MODERNA,IM 1015719,,,M,Rabies breakthrough infection,Yes,,Not Reported,Not Reported,,Not Reported,,08/13/2020,,,UNK,,,,,,"['Rabies', 'Vaccine breakthrough infection']",UNK,NOVARTIS VACCINES AND DIAGNOSTICS,UN 1015773,WI,99.0,F,Resident passed away in her sleep. No s/s of adverse events leading up to the residents death. Resident was previously declining- MD stated the vaccine had nothing to do with the death.,Yes,02/02/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/02/2021,1.0,SEN,"aspirin 81 mg,",skin rash,"Demenita, GERD, Heart failure, Kidney disease, stage 3,",,"Lisinipril, Penicillins",['Death'],2,MODERNA,IM 1015814,MN,54.0,F,Resident developed low grade fever next day and it continued through Monday morning with some mottling starting to appear on resident's skin. Sent to ER on Monday. Resident sent to higher level of care and diagnosed with pneumonia and bilateral pulmonary embolism,Not Reported,,Yes,Yes,2.0,Not Reported,U,02/04/2021,02/05/2021,1.0,SEN,"Aubagio, Vitamin C, Baclofen, Acetaminophen, Vitamin D3, Nystatin, Protonix, Polyethelene Glycol, Methenamine, Losartan Potassium, D-Mannose, Modafinil, Hydrocholorthiazide, Meloxicam, Furosemide, Calcium Carbonate, Melatonin, Duloxetine HC",,"multiple sclerosis, Neuromuscular dysfunction of bladder, hypertension, depressive disorder,",,"Lisinopril, Penicillins, Sulfa","['Livedo reticularis', 'Pneumonia', 'Pulmonary embolism', 'Pyrexia']",UNK,MODERNA,IM 1015839,NY,77.0,M,"SARS-CoV-2 PCR positive on 2/3/2020, admitted to the hospital for hypoxia",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/20/2021,02/03/2021,14.0,UNK,,,"hypertension, CAD s/p CABG, CKD, type 2 diabetes, hyperlipidemia, HFrEF",,,"['COVID-19', 'Hypoxia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1015854,NC,93.0,M,"Client reports he received 1st dose of COVID-19 vaccination early January, 2021, shortly after became SOB, continued for 3 weeks, worsening in the last week with increased weakness and lethargy, and received 2nd dose on 2/2/2021, and was seen by his PCP, PA Cerner on 2/3/21, sent to to the ED of Hospital was admitted for 2 days",Not Reported,,Yes,Yes,2.0,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,"Finesteride, Allopurinol, duloxetine","BPH, CKD, CAD",As above,,NKA,"['Asthenia', 'Dyspnoea', 'Lethargy', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1015866,OK,31.0,F,"approx. 10 minutes after receiving the vaccine client c/o dizziness and light headedness. a few minutes later started c/o headache and neck stiffening, left side weakness. NP said her left pupil was not responding the same as the right one. Benadryl 50mg Im given, EMSA called and client was transported to hospital.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/29/2021,01/29/2021,0.0,OTH,"Metformin, Singulair, Gapentin, plaquenil routine and cyclobenzadine and prednisone prn",none,"Lupus, fibromyalgia, diabetes type 2,",,Penicillin,"['Computerised tomogram', 'Dizziness', 'Headache', 'Hemiparesis', 'Laboratory test', 'Musculoskeletal stiffness', 'Pupillary disorder']",2,PFIZER\BIONTECH,IM 1015921,NC,50.0,F,"After the first dose the patient noticed some numbness and ""flashing"" in the fingers of her left hand. She also had fever, chills and ""rigors. Her left hand was painful and swollen. She saw her PCM and her medication dose was increased from 5mg to 10mg daily. However, her left hand remains discolored, swollen and bluish areas on her second and fifth digits. These areas have now become almost necrotic and she is being referred to VASCULAR for possible amputation.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/25/2021,01/25/2021,0.0,MIL,NORVASC 10MG QD,UNKNOWN,RAYNAUDS SYNDROME,,ERYTHROMYCIN,"['Chills', 'Full blood count', 'Glycosylated haemoglobin', 'Hypoaesthesia', 'Laboratory test', 'Lipids', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Skin discolouration']",2,MODERNA,IM 1015996,FL,86.0,M,Family reported patient expired 1/31/2021.,Yes,01/31/2021,Not Reported,Not Reported,,Not Reported,,01/14/2021,01/01/2021,,PUB,,,,,,['Death'],1,MODERNA,IM 1016006,TX,34.0,F,"Abdominal pain that began at center of abdomen upon waking up at 8 am on 2/7/2021 and progressively got worse throughout the day . Developed nausea and multiple episodes of vomiting around 3 pm. Abdominal pain then moved to RLQ, was persistent, dull and achy, worsened with movement. Pain was still present throughout the night and the next day, went to the ER for evaluation. There was concern for appendicitis. Imaging and labs could not confirm diagnosis but examination was concerning. Laparoscopic surgery was performed and confirmed appendicitis.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/04/2021,02/07/2021,3.0,PVT,"Oral contraceptive pill, folic acid, multi ivitamin",None,None,,None,"['Abdominal pain', 'Abdominal pain lower', 'Appendicitis', 'Computerised tomogram abdomen', 'Laboratory test normal', 'Laparoscopic surgery', 'Nausea', 'Pain', 'Ultrasound abdomen normal', 'Ultrasound scan vagina', 'Vomiting']",1,PFIZER\BIONTECH,IM 1016067,MA,84.0,F,"Resident was weak, fatigued and had a fever of 101. F the following morning after receiving the 2nd dose of vaccine. Later in the day she was feeling better and vital signs were WNL. The next morning, she was found unresponsive and pronounced dead by paramedics.",Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,SEN,"Metolazone, potassium CL, Torsemide, Acetaminophen, Loperamide, melatonin, tramadol, certirzine, Eliquis,",nasal congestion,"diabetes, heart failure, Afib, HTN",,"Procaine, epinephrine","['Asthenia', 'Death', 'Fatigue', 'Pyrexia', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 1016088,MN,79.0,F,"Patient given vaccination at pharmacy around 11am Thursday 2/4/21. No problems at time of administration or 15 minutes following. Spouse reports patient experienced generalized weakness and joint pain at around 3am 2/5/21. She could ""hardly get out of bed."" They brought her to the ED and she was admitted to the hospital for observation. She was discharged on Sat 2/6/21 and sent home with Rx for prednisone.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/04/2021,02/05/2021,1.0,PHM,Carvedilol 37.5mg BID Warfarin 5mg daily Furosemide 20mg daily Budesonide Neb 0.5mg/2ml BID Iprat/Albut Neb BID Entresto 97/103mg BID Hydralazine 50mg TID Duloxetine 60mg daily Omeprazole 40mg daily,,CHF COPD HTN,,ACEI,"['Arthralgia', 'Asthenia', 'Mobility decreased']",1,MODERNA,IM 1016092,TX,60.0,F,"I became dehydrate and confused. This was noticeable in the hours leaving for the hospital at about 8:00 p.m. Once at the hospital, I was combatant and didn't recognize family. I continued in this state while the Dr's at the hospital ran tests. Around the 16th and/or 17th, after 2-3 days of steroids, I could answer Dr's questions and recognized family.",Not Reported,,Not Reported,Yes,8.0,Not Reported,Y,01/12/2021,01/15/2021,3.0,PVT,Saxenda Biotin Iron Vitamin D Tramadol Copaxone Baclofen Amitryptyline Lisinopril Amlodipine,none,Multiple Sclerosis,,None,"['Aggression', 'Blood test', 'Cognitive disorder', 'Computerised tomogram', 'Confusional state', 'Dehydration', 'Electroencephalogram', 'Lumbar puncture', 'Magnetic resonance imaging']",1,MODERNA,IM 1016097,IL,70.0,M,Patient died 02/08/21,Yes,02/08/2021,Not Reported,Not Reported,,Not Reported,N,01/20/2021,02/08/2021,19.0,PVT,"Amlodipine, carvedilol, clopidrogrel, cyclobenzaprine, docusate sodium, ferrous sulfate, guaifenesin, norco, insulin nph, levothyroxine, magnesium, metformin, nitrostat, rosuvastatin, spironolactone, tramadol, warfarin",,"CABG-2014, CAD, HTN, hyperlipidemia, systolic murmur, type 2 diabetes, diabetic neuropathy, cervical dystonia, benign essential tremor, degenerative disc disease, intermittent claudication, PVD, former smoker-greater than 30 pack year, cervical spinal stenosis, long-term use of anticoagulant",,"Hydrochlorothiazide, ACE inhibitors, Lisinopril, Valsartan, Angiotensin Receptor blockers",['Death'],1,MODERNA,IM 1016111,NC,75.0,F,"her arm was sore but no other adverse reactions until Saturday, Feburary 6th 2021 she had stroke between 4 and 6pm. She died within 6 to 7 hours later.",Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,01/24/2021,02/06/2021,13.0,PVT,lipatore high blood pressure meds a-fib medications,no,High Blood Pressure High Cholesterol A-Fib,,Penicillin Amoxicillin Sulfa Drugs,"['Cerebrovascular accident', 'Death', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 1016128,IA,61.0,F,"Transient global amnesia and fall the day after vaccination Elevated ESR 51 and CRP 3 Symptoms resolved spontaneously except for labs, still monitoring",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,02/03/2021,02/04/2021,1.0,PVT,Current Outpatient Medications Medication Sig Dispense Refill ? azelastine HCl (ASTEPRO) 0.15 % nasal spray USE 1 TO 2 SPRAYS IN EACH NOSTRIL TWICE DAILY AS NEEDED 30 mL 6 ? levothyroxine (SYNTHROID) 25 MCG tablet TAKE 1 TABLET BY MOUTH DAI,none,Traumatic brain injury Mood disorder HTN (hypertension) Hyperlipidemia Memory disorder Mild persistent asthma 12/28/2014 Perennial allergic rhinitis 2/2/2015,,beta blockers,"['C-reactive protein normal', 'Fall', 'Red blood cell sedimentation rate increased', 'Transient global amnesia']",UNK,PFIZER\BIONTECH,IM 1016147,IN,46.0,F,One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and was short of breath unable to talk by the time I reached ER (anaphylaxis). Also rash to chest and arms.,Not Reported,,Yes,Yes,1.0,Not Reported,N,01/21/2021,01/21/2021,0.0,PVT,"singulair, lexapro, norvasc, iron, multivitamin, potassium, pepcid, benadryl, prilosec",none,"asthma, hypertension, GERD",covid 19 Pfizer- had a rash for 4 weeks,Erythromycin - nausea and vomiting Amoxicillin - rash,"['Aphasia', 'Dyspnoea', 'Rash', 'Swollen tongue']",2,PFIZER\BIONTECH,IM 1016148,IL,19.0,F,Patient is a 19yo female presenting to the ED with chest pain. Patient received her second Moderna vaccine two days. Since then she has been having symptoms of chills and myalgias. This morning she had severe chest pain in the middle of her chest. It made it difficult to breathe. Patient had no side effects from 1st dose of vaccine and denies any symptoms prior to receiving 2nd dose.,Not Reported,,Not Reported,Yes,,Not Reported,Y,01/27/2021,01/30/2021,3.0,PVT,Unknown,Unknown,Unknown,,Unknown,"['Blood creatine phosphokinase MB increased', 'C-reactive protein increased', 'Chest pain', 'Chills', 'Computerised tomogram thorax normal', 'Dyspnoea', 'Electrocardiogram ST segment elevation', 'Electrocardiogram abnormal', 'Fall', 'Fibrin D dimer', 'Injection site erythema', 'Injection site oedema', 'Injection site warmth', 'Myalgia', 'Pain', 'Painful respiration', 'Red blood cell sedimentation rate increased', 'SARS-CoV-2 test negative', 'Troponin increased']",2,MODERNA,IM 1016155,KS,85.0,F,"2/7/2021 at 0630, resident found in recliner without pulse or respirations. Resident had not been found to have any adverse reactions to the vaccine between the time of the vaccine on 2/4 until found deceased on 2/7.",Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,PVT,Align Capsule 1 capsule QD Aspirin 81 mg QD Cholecalciferol 125 mcg QD Donepezil HCl 10 mg QHS Ensure Max Protein BID Furosemide 20 mg QD Potassium Chloride ER 10 MEQ BID Proventil HFA TID,Acute Exacerbation CHF Cellulitis of intergluteal fold due to decubitus ulcer,Unspecified Dementia without Behavioral Disturbance Edema Hypokalemia Chronic Bronchitis Heart Failure Vitamin D Deficiency Atherosclerotic Heart Disease of Native Coronary Artery Without Angina Pectoris History of Aortic Stenosis LBBB,,No Known Allergies,"['Bundle branch block left', 'Death', 'Pulse absent', 'Respiratory arrest']",2,MODERNA,IM 1016222,TX,74.0,F,"My mom only had site soreness after her covid vaccine on 1/21 which resolved within a couple days. However, she died in the early morning hours of 1/25, she was fine the day before, no sign of injury. We found her collapsed on the ground and although we tried cpr she was already dead. She had gone to the hospital on 12/28 for shortness of breath, angina and symptomatic anemia, her ekg was unchanged and blood work normal except for anemia. The cardiologist did not think a cardiac cath was needed. Her shortness of breath improved with a blood transfusion and a dose of lasix (no heart failure).",Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/25/2021,4.0,PVT,"Coreg, Ranexa, Bayer low dose Aspirin, Brilinta, Tums, Pantoprazole, Nitro 0.4mg sq prn, Imdur, Rosuvastatin, Glimiperide, Sucralfate",3 weeks prior to immunzation hospitalized for one day due to symptomatic anemia and got a blood transfusion,"Hypertension, CAD s/p cabg 1996 s/p multiple stents last 2013, history of stroke 1996, high cholesterol, diabetes type 2, iron deficiency anemia",,"Contrast dye, lisinopril","['Anaemia', 'Angina pectoris', 'Blood test abnormal', 'Death', 'Dyspnoea', 'Electrocardiogram', 'Injection site pain', 'Resuscitation', 'Syncope', 'Transfusion']",1,PFIZER\BIONTECH,IM 1016231,NH,33.0,M,"Within twenty-four hours I had a 102.7 degree temperature which lasted a day then gradually went away, I took Tylenol for the fever. For then next couple days just felt rundown. Then three days post vaccine I began having some chest discomfort and shortness of breath. That night around one thirteen the morning I went to Emergency Department. they took a ECG and drew labs. the ECG showed normal rhythm just a little elevated and my Blood pressure was elevated. Upon the attending physician getting my lab work back i was admitted for my triponin levels being elevated. I was taken for chest X-rays and a Cat Scan per their pulmonary embolism protocols. Both of which showed nothing. The next day i had a Echocardiogram, and Cardiac Catheterization, and a Cardiac MRI.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/30/2021,01/31/2021,1.0,PVT,Paroxetine 20Mg.,None known.,Psoriasis.,,None known.,"['Blood pressure increased', 'Catheterisation cardiac', 'Chest X-ray', 'Chest discomfort', 'Computerised tomogram', 'Dyspnoea', 'Echocardiogram', 'Electrocardiogram', 'Feeling abnormal', 'Magnetic resonance imaging heart', 'Pyrexia', 'Troponin']",2,MODERNA,IM 1016296,IA,43.0,F,"Primarily pruritic rash. Started on the left arm near injection site. Exacerbated by day of onset of rash after spending time in a hot tub. Urticaria rash present prior to exposure to warm water. Urticaria at first even though 4 days after vaccination. Then started on right arm. Later spread to trunk, upper legs (anterior & posteriorly), then neck, scalp line (face spared, as were palms and soles of feet). Rash was distinct maculopapules, no pustules, no vesicles, no petechiae; + blanching. No other systemic symptoms, no other physical exam findings, + dermatographia. Started on medrol dose pack on 1/30/2021. Seen in ED on 2/1/2021 and hospitalized until 2/6. Seen in ED again 2/7/2021. Treatment History: 2/1 - 2/6/2021 Ceftriaxone 1 gm IVP on 2/1 Famotidine 20 mg IVP Q12 hrs Benadryl 50 mg IVP Q6 hrs prn Hydroxyzine oral prn Ativan oral prn Methylprednisolone 40 mg Q6 hrs x 4 doses, then 40 mg Q12 hrs x 3 days Discharged pn Prednisone 40 mg BID x 4 days, 30 mg BID x 4 days, 20 mg BID x 4 days, 10 mg BID x 4 days, 10 mg daily x 4 days Also given betamethasone dipropionate augmented 0.05% topically BID prn 2/7 Changed to zyrtec from hydroxyzine",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/25/2021,01/30/2021,5.0,PVT,"fluoxetine 40 mg daily, zolpidem 5 mg HS",Had strept throat within the month prior to the vaccine,"anxiety & depression, nephrolithiasis, paroxysmal SVT, ? h/o hyperparathyroidism",,No Known Drug Allergies,"['Blood culture negative', 'Blood glucose increased', 'C-reactive protein normal', 'CD4/CD8 ratio', 'Differential white blood cell count', 'Eosinophil percentage', 'Fibrin D dimer', 'Full blood count', 'Injection site rash', 'Lymphocyte count', 'Lymphocyte percentage increased', 'Metabolic function test normal', 'Neutrophil percentage increased', 'Pallor', 'Rash', 'Rash maculo-papular', 'Rash pruritic', 'Tryptase', 'Urticaria', 'White blood cell count increased']",2,MODERNA,IM 1016590,FL,,F,"Rectal bleeding/ Bleeding from the rectum; A spontaneous report was received from a consumer concerning a 67-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced rectal bleeding. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Xarelto, Sotalol, Synthroid, Vitamin D, Calcium Vitamin b12, Clonazepam, Hydrocodone and Metamucil. On 26 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 032L20R) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient experienced rectal bleeding. The subject informed that she got the vaccine for the first time on 26 Jan 2021 and did not tell them that she takes Xarelto. Later she experienced bleeding from her rectum while taking a bowel movement. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event rectal bleeding was not reported.; Reporter's Comments: This case concerns a 67year old female patient with medication history within two weeks prior to the event, included Xarelto, Sotalol, Synthroid, Clonazepam, Hydrocodone and Metamucil. who experienced a serious unexpected event of Rectal haemorrhage. The event occurred approximately one day after first dose of the study medication administration. Based on medication the patient is taking, Xarelto which is blood thinner, the event is assessed as unlikely related to mRNA-1273.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/27/2021,1.0,UNK,XARELTO; SOTALOL; SYNTHROID; VITAMIN D NOS; CLONAZEPAM; HYDROCODONE; METAMUCIL CITRON,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Rectal haemorrhage'],1,MODERNA,OT 1016598,NC,,M,"Vasovagal syncope; I suffered incontinence; Blood pressure dropped; A spontaneous report was received from a 29-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vasovagal syncope, blood pressure dropped, and incontinence. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included multivitamin and fish oil. On 27 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. Approximately five minutes after receiving the vaccine, the patient experienced vasovagal syncope. The patient reported his blood pressure dropped too much and he passed out for about ten seconds. He also suffered incontinence. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On 27 Jan 2021, the outcome of the events, experienced vasovagal syncope, blood pressure dropped, and incontinence, were considered resolved.; Reporter's Comments: This case concerns 29-year-old male patient, who experienced non serious unexpected events of blood pressure decreased with vasovagal syncope and incontinence. The events occurred 5 minutes after the first dose of mRNA-1273 vaccine. No treatment was reported, and outcome of reported events was reported as resolved. All events were assessed as related to mRNA-1273 vaccine due to temporal association.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,UNK,MULTIVITAMINS [VITAMINS NOS]; FISH OIL,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Blood pressure decreased', 'Incontinence', 'Loss of consciousness', 'Syncope']",1,MODERNA,OT 1016599,,77.0,M,"Hearing loss in left ear; A spontaneous report was received from a 77-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hearing loss in the left ear. The patient's medical history was not provided. No relevant concomitant medications were reported. On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient started to experience hearing loss in the left ear. Tinny sound in left ear. Treatment for the events was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the event, hearing loss in the left ear, was unknown.; Reporter's Comments: This case concerns a 77 year-old, male patient, who experienced event of hearing loss in the left ear . The event occurred 2 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/23/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Deafness unilateral', 'Tinnitus']",1,MODERNA,OT 1016605,,,M,"Sepsis; A spontaneous report was received from a consumer post , concerning an approximately 55-year-old, male physician who received Moderna's COVID-19 vaccine (mRNA-1273) and developed sepsis, resulting in death. There was no medical history provided. There were no concomitant medications provided. On an unknown date (Thursday), the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. According to the post, two days after vaccine administration, the patient died of sepsis on Saturday. Action taken with mRNA-1273 in response to the event was not applicable. The event, sepsis, was considered fatal. The patient's date of death was not provided. The cause of death was reported as sepsis.; Reporter's Comments: This case concerns a 55-year-old, male subject, who experienced a serious unexpected event of Sepsis. Sepsis occurred after first dose of mRNA-1273 vaccine administration. On an unknown date, two days after vaccine administration, the patient died of sepsis. Treatment for the event was not provided. The patient's medical history was not provided. The patient is a physician. Concomitant product use was not reported. Very limited information regarding this event has been provided at this time and no definite diagnosis or autopsy report have been provided. Based on the current available information and temporal association between the use of the product and the start date of the event of Sepsis, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Sepsis",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Death', 'Sepsis']",1,MODERNA,OT 1016608,PA,30.0,F,"sudden onset lower lip angioedema- only on the right side of my lip; This is a spontaneous report from a contactable Other HCP. This other HCP reported different events for the same patient during diffferient vaccination dose. This case is referred to the second vaccine dose A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL3247 intramuscular on 13Jan2021 12:30 second dose at SINGLE DOSE for covid-19 immunisation. Facility type vaccine: Hospital . Vaccine location: right arm Medical history included asthma, eczema, hypersensitivity, anxiety and depression. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20), bupropion hydrochloride (WELLBUTRIN XL), fluoxetine hydrochloride (PROZAC), rizatriptan (RIZATRIPTAN), salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), levocetirizine dihydrochloride (XYZAL), betamethasone (BETAMETHASONE). The patient previously took aspirin and experienced rash. The patient experienced flushing, palpitations and hyperhidrosis after the first dose of bnt162b2 vaccine. The patient experienced sudden onset lower lip angioedema- only on the right side of my lip on 16Jan2021 20:30 with outcome of recovered. The action taken was not applicable. Therapeutic measures were taken: benadryl inhaler self treated, consultation w/allergist and allergy testing. The reporter stated ""developed sudden onset lower lip angioedema only on the right side of my lip. I took 50mg benadryl and my inhaler and monitored- I never developed itching, additional swelling, difficulty breathing or other symptoms of anaphylaxis. Swelling had resolved by morning. I had no other new exposures that have yet been identified, although I am going through a work up with an allergist.""; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021073355 Same patient/ drug, different dose/AE.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/16/2021,3.0,PVT,JUNEL FE 1/20; WELLBUTRIN XL; PROZAC; RIZATRIPTAN; ALBUTEROL [SALBUTAMOL SULFATE]; FLONASE [FLUTICASONE PROPIONATE]; XYZAL; BETAMETHASONE,,Medical History/Concurrent Conditions: Anxiety; Asthma; Depression; Eczema; Environmental allergy,,,"['Angioedema', 'Flushing', 'Hyperhidrosis', 'Palpitations', 'Swelling']",2,PFIZER\BIONTECH,OT 1016609,OR,,F,"Profuse nose bleed/ I woke up with another profuse nose bleed. Bled very heavily for 1/2 hour; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 75-year-old female patient who received first dose of bnt162b2 (Covid-19, Lot#: EL3247), via an unspecified route of administration on 16Jan2021 at 05:30 PM on Right arm at single dose for covid-19 immunisation. She is not pregnant. Facility type vaccine was other. No other vaccine in four weeks. Medical history included Known allergies and pacemaker, a-fib, pulmonary embolism. Concomitant medications included apixaban (ELIQUIS), fexofenadine hydrochloride (ALLEGRA), simvastatin and escitalopram. The following day she had a profuse nose bleed. Ended up at Urgent Care. They were able to stop it after 15 min. An ENT Dr cauterized one of her nostrils. On Sunday, 24Jan, at 3:00 am, she woke up with another profuse nose bleed. Bled very heavily for 1/2 hour. Drs. are trying to find reason for this profuse bleeding. Unknown yet. The event started from 17Jan2021 02:00 PM. AE resulted in: [Emergency room/department or urgent care]. The outcome of the event was not recovered. Treatment was received included Dr.'s visit. Nose bleeding stopper. Saline drops. No covid prior vaccination. No covid tested post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/17/2021,1.0,UNK,ELIQUIS; ALLEGRA; SIMVASTATIN; ESCITALOPRAM,,"Medical History/Concurrent Conditions: Allergy; Atrial fibrillation; Pacemaker syndrome (Other-medical-history: pacemaker, a-fib, pulmonary embolism/ Structured information(Patient episode name): pacemaker, a-fib, pulmonary embolism); Pulmonary embolism",,,['Epistaxis'],1,PFIZER\BIONTECH, 1016610,AL,45.0,F,"Syncope; passed out; This is a spontaneous report from a contactable pharmacist reported that a 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular on the left arm on 25Jan2021 15:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received flu vaccine on an unspecified date for immunization and experienced fever. On 25Jan2021, the patient was experienced syncope and passed out. She woke up within the next couple of minutes and was monitored. The patient eaten food. The outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, syncope and passed out, and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association, and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/25/2021,0.0,UNK,,,,,,"['Loss of consciousness', 'Syncope']",1,PFIZER\BIONTECH,OT 1016611,AL,61.0,M,"hives; anxious; This is a spontaneous report from a contactable other healthcare professional. A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the right leg on 25Jan2021 (lot number EN5318 and expiry date unknown) at single dose for Covid-19 immunization in a nursing home/senior living facility. Medical history included COVID prior vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. On 25Jan2021, the patient experienced hives and was anxious, the patient was taken to the hospital. The events resulted in emergency room/department or urgent care. The events caused hospitalization on 25Jan2021. The outcome of the events hives and anxious was unknown.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the urticaria and anxiety. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/25/2021,01/25/2021,0.0,SEN,,,Medical History/Concurrent Conditions: COVID-19 (prior vaccination),,,"['Anxiety', 'Urticaria']",1,PFIZER\BIONTECH,OT 1016612,AL,29.0,F,"trouble breathing; Patient experienced itching on legs arms and face along with hives; Patient experienced itching on legs arms and face along with hives; Headache getting severe by the minute; This is a spontaneous report from a contactable pharmacist. A 29-year-old female patient received 2nd dose of bnt162b2 (BNT162B2; lot number EN5318) on 25Jan2021 intramuscular at right arm for COVID-19 immunization. Medical history was not reported. The patient had no COVID prior to vaccination. Historical vaccine include BNT162B2 for COVID-19 immunization. The patient had no other vaccine in weeks, concomitant drugs was none. The patient experienced headache getting severe by the minute. Patient experienced itching on legs arms and face along with hives and trouble breathing. Event start date was 25Jan2021. One epinephrine was received. Patient was taken to the hospital. The events resulted in Emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events headache, dyspnea, urticaria and pruritus are possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/25/2021,0.0,SEN,,,,,,"['Dyspnoea', 'Headache', 'Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,OT 1016613,NJ,40.0,F,"hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she found it hard to swallow; little nervous; very lightheaded; her husband told her she looked very pale; her heart rate jumped to over 150, according to her (company name) watch; she had pins and needles up and down her entire left arm; her left arm initially felt almost totally numb from her shoulder to her finger tips, and then she felt pins and needles down the entire length of her arm.; maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (Lot Number: EK4176), via an unspecified route of administration in left arm on 25Jan2021 12:50 at single dose for covid-19 immunization. Medical history included coeliac disease from Mar2013 and ongoing. There were no concomitant medications. She said initially she was OK after she received the COVID-19 Vaccine. She said after about 5 minutes in from receiving the COVID-19 Vaccine, she had a hard time catching her breath, and her throat felt a little tight, and she found it hard to swallow. She said she thought she was nuts at first, and was a little nervous for a minute. She said the staff at the vaccination center made people wait 15 minutes after receiving the COVID-19 Vaccine before being allowed to leave. She said she actually spoke to the vaccination center staff while she was waiting for the 15 minutes to go by. She said she didn't say anything to the staff because she thought she might be crazy. She said she scheduled her second COVID-19 Vaccine dose, and after the 15 minutes went by, she left. She said her husband had drove her to and from the COVID-19 Vaccine facility location. She said 5 minutes into her car trip after leaving the facility, she became very lightheaded. She said her throat began to feel tight again (saying the throat tightness was worse than what she first experienced at the convention center), and she kept trying to clear her throat. She said her husband told her she looked very pale. She said her heart rate jumped to over 150, according to her Apple watch. She said she had pins and needles up and down her entire left arm. She clarified her left arm initially felt almost completely numb from her shoulder to her finger tips. She said she thought that maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm. She clarified the numbness improved in her left arm, but she still has a pins and needle sensation down the length of her left arm. Patient asked if it is OK for her to received the second COVID-19 Vaccine based on what she experienced after the first COVID-19 Vaccine dose. Reported if she would have been driving the car after she received her first COVID-19 Vaccine dose, she would have had to pull over on the side of the road because of the side effects she was experiencing. Reported the side effects she experienced in the car after leaving the vaccination facility, resolved after a couple minutes, with the exception of the pins and needles and numbness in her left arm. She said the pins and needles, and numbness in her left arm improved, but was still present. Reported she had a well visit not too long ago, and her blood work was perfectly fine. The outcome of the events Peripheral nerve injury, Pins and needles, Numbness of upper extremities was recovering, other events was recovered on 25Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,UNK,,Celiac disease,,,,"['Blood test normal', 'Dizziness', 'Dysphagia', 'Dyspnoea', 'Heart rate increased', 'Hypoaesthesia', 'Injection site hypoaesthesia', 'Nervousness', 'Pallor', 'Paraesthesia', 'Peripheral nerve injury', 'Throat clearing', 'Throat tightness']",1,PFIZER\BIONTECH, 1016614,AL,46.0,F,"headache with hives; headache with hives; This is a spontaneous report from a contactable pharmacist. A 46-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the right arm on 25Jan2021 (lot number EN5318 and expiry date unknown) at single dose for Covid-19 immunization in a nursing home. Medical history included latex allergy, mushrooms allergy. The patient has no covid prior vaccination. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 first dose at the right arm on unspecified date for Covid-19 immunization. The patient had no other vaccine in four weeks. On 25Jan2021, the patient experienced headache with hives and was taken to the hospital. The events resulted in emergency room/department or urgent care. The events caused hospitalization on 25Jan2021. The outcome of the events headache with hives was unknown.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of headache with hives cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/25/2021,01/25/2021,0.0,SEN,,,Medical History/Concurrent Conditions: Allergy to molds; Latex allergy,,,"['Headache', 'Urticaria']",2,PFIZER\BIONTECH,OT 1016615,OH,87.0,F,"UTI; This is a spontaneous report from a contactable consumer (patient). A 87-year-old female patient received the first dose of bnt162b2 (Lot number: EL3249), via an unspecified route of administration in left arm on 21Jan2021 09:00 at single dose for covid-19 immunization. Medical history included hypertension (HTN), atrial fibrillation, Allergies to Sulfa. Concomitant medication included diltiazem, apixaban (ELIQUIS), metoprolol, budesonide, formoterol fumarate (SYMBICORT). The patient experienced urinary tract infection (UTI) on 24Jan2021 14:00. The patient received the Antibiotics as treatment. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient was no pregnant. The outcome of event was recovered on Jan 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/24/2021,3.0,PVT,DILTIAZEM; ELIQUIS; METOPROLOL; SYMBICORT,,Medical History/Concurrent Conditions: Atrial fibrillation; Drug allergy; Hypertension (HTN),,,['Urinary tract infection'],1,PFIZER\BIONTECH, 1016616,GA,25.0,F,"syncopal episodes; Vomited 40+ times; blood pressure dropped to 70/40; Elevated bilirubin; elevated liver enzymes (ALT, AST); elevated liver enzymes (ALT, AST); This is a spontaneous report from a contactable other health professional (patient herself). A 25-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration on 28Dec2020 12:30 in right arm at single dose for covid-19 immunization. The patient had COVID prior vaccination. Concomitant medication in two weeks included levothyroxine sodium (SYNTHROID), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient experienced vomited 40+ times, syncopal episodes, blood pressure dropped to 70/40, elevated bilirubin, elevated liver enzymes (ALT (alanine aminotransferase), AST (aspartate aminotransferase)) on 28Dec2020 19:30. Events resulted in emergency room/department or urgent care. IV fluids were received for events. The patient was not tested COVID post vaccination. Outcome of elevated bilirubin was recovered on an unspecified date, and outcome of other events were recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,PVT,SYNTHROID; ADDERALL,,Medical History/Concurrent Conditions: COVID-19,,,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood bilirubin increased', 'Blood pressure decreased', 'Hepatic enzyme increased', 'Syncope', 'Vomiting']",1,PFIZER\BIONTECH, 1016617,NY,70.0,M,"He almost passed out a couple times; Fever; weak; Awful shakes; Sweating; Chills; Stomach like on fire; Diarrhea; He lost about 4 pounds; has autoimmune disease, lupus; has autoimmune disease, lupus; he thinks he was almost dehydrated; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration at right arm, on 22Jan2021 14:30, at SINGLE DOSE for COVID-19 immunization. Medical history included autoimmune disease, systemic lupus erythematosus diagnosed in 2018 (over 3 years ago). Concomitant medication included baricitinib taken in a clinical trial, a study, unknown if 2 or 4mg plus placebo for lupus. On 25Jan2021, at 14:30 in the afternoon, the patient was sweating and it was awful shakes and chills, and it lasted over three hours, and on 26Jan2021 he was weak. The patient lost about 4 pounds on 25Jan2021, with all the water running out of of him. The sweating and shakes happened so suddenly and stomach felt like it was on fire on 25Jan2021. The stomach feeling like it is on fire has gone away, he almost passed out a couple times on an unspecified date, he had diarrhea on 25Jan2021, it was unbelievable. The sweats with awful shakes has gone away on 25Jan2021, but it was horrible, he has recovered with a lasting effect, he is a little weak, but he can move he had to take his dog to the beautician. Diarrhea: the is not eating (had no breakfast this morning) however it was also reported that the patient had a little slice of roast beef and blackberries not many, and he has been drinking, he thinks he was almost dehydrated in Jan2021, he drank about a quart of water so far today. On an unspecified date, the patient had fever. His doctor called the day before and said it was alright; his rheumatologist said it was ok. Outcome of the events he almost passed out a couple times, fever, chills, weak, Diarrhea, He lost about 4 pounds, he thinks he was almost dehydrated was unknown; the events sweating, awful shakes recovered on 25Jan2021 with sequalae, while Stomach like on fire recovered in 2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/01/2021,,UNK,BARICITINIB,,Medical History/Concurrent Conditions: Lupus erythematosus,,,"['Asthenia', 'Chills', 'Decreased appetite', 'Diarrhoea', 'Dizziness', 'Dyspepsia', 'Hyperhidrosis', 'Loss of consciousness', 'Pyrexia', 'Tremor', 'Weight decreased']",1,PFIZER\BIONTECH, 1016618,FL,47.0,F,"Cellulitis in the arm; Fever; strong muscle pain; chills; headache; muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL1283), intramuscularly on 25Jan2021 at 10:00 AM in Left arm at single dose for COVID-19 immunization. The patient medical history included Hypothyroidism and COVID prior vaccination. No known allergies, no allergies to medications, food, or other products. The patient's concomitant medications reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ek4176), on 07Jan2021 in Left Arm at single dose for COVID-19 immunization at age of 47-year-old. The patient experienced fever, strong muscle pain, chills, headache and muscle weakness on 26Jan2021 at 03:00 AM; Cellulitis in the arm on 27Jan2021 at 08:00 AM. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events fever, strong muscle pain, chills, headache and muscle weakness included Acetaminophen, ibuprofen; no treatment was received for the event Cellulitis in the arm. The outcome of the events was not recovered. The report was reported as non-serious for event ""Cellulitis in the arm"", with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,UNK,,,Medical History/Concurrent Conditions: COVID-19 (COVID prior vaccination); Hypothyroidism,,,"['Cellulitis', 'Chills', 'Headache', 'Muscular weakness', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,OT 1016619,VA,86.0,F,"Atrial fibrillation; pleurisy (flank pain, diagnosed as pleurisy at the ER); pleurisy (flank pain, diagnosed as pleurisy at the ER); This is a spontaneous report from a contactable consumer. An 86-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: E13248, expiry date: unknown), via an unspecified route of administration on 23Jan2021 07:00 at single dose (Left arm) for COVID-19 immunization. Medical history included well managed hyperlipidemia and hypertension, arthritis, meningioma benign, Bell's palsy (onset was 2010) resolved with sequelae. Known allergies include Sulfa, Codeine, and Macrobid. The patient is not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), losartan, hydrochlorothiazide (HTZ), desmopressin, fenofibrate. Facility type vaccine was reported as Doctor's office/urgent care. The patient experienced atrial fibrillation, pleurisy (flank pain, diagnosed as pleurisy at the ER) on 24Jan2021 20:00. Events resulted in Emergency room/department or urgent care. Treatment of IV pain medication (unk) was given. Patient had no covid prior vaccination, covid was not tested post vaccination. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/24/2021,1.0,PVT,CYMBALTA; LOSARTAN; HTZ; DESMOPRESSIN; FENOFIBRATE,,Medical History/Concurrent Conditions: Arthritis; Bell's palsy (Bell's palsy (onset was 2010) resolved with sequelae); Hyperlipidemia; Hypertension; Meningioma benign; Sulfonamide allergy,,,"['Atrial fibrillation', 'Flank pain', 'Pleurisy']",1,PFIZER\BIONTECH, 1016620,AZ,,F,"Started showing symtpoms of odynophagia (pain in swallowing) on 19Jan2021; Had ulcerative pharyngitis; clean based yellow ulcers on tonsillar beds bilaterally; This is a spontaneous report from a non-contactable consumer. A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient started showing symptoms of odynophagia (pain in swallowing) on 19Jan2021. The patient also experienced ulcerative pharyngitis, clean based yellow ulcers on tonsillar beds bilaterally. No purulent discharge, no lymphadenopathy, no angioedema, mon screen negative, COVID screen negative, strep throat negative, viral panel negative on an unspecified date. The patient was hospitalized for 2 days due to the events. The patient received treatment for the events. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/16/2021,01/19/2021,3.0,PUB,,,,,,"['Mononucleosis heterophile test negative', 'Odynophagia', 'Pharyngitis', 'Respiratory viral panel', 'SARS-CoV-2 test negative', 'Streptococcus test negative', 'Tonsillar ulcer', 'Viral test negative']",1,PFIZER\BIONTECH, 1016621,TX,65.0,F,"All my stroke symptoms returned immediately; numbness on left side of face, left hand, left foot, left chin; Weakness; pain; all her stroke symptoms returned immediately. Numbness on left side of face, left hand, left foot, left chin. Weakness and pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PF EL3249), via an unspecified route of administration in arm left, on 16Jan2021 12:00 PM at single dose for COVID-19 immunisation. Medical history included massive stroke in Jul2018, left side effected; numbness on left side of face, left hand, left foot, left chin, weakness and pain from stroke 2 years ago; asthma. Patient was allergic to shrimp, lobster. Patient is not pregnant. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Concomitant medications included Losartan, Amlodipine, acetylsalicylic acid (ASPIRIN), Atorvastatin, Montelukast. Patient was previously allergic to codine, tetracycline. On an unspecified in Jan2021 (reported as 15Jan2021, pending clarification), all her stroke symptoms returned immediately. Numbness on left side of face, left hand, left foot, left chin, weakness and pain from stroke 2 years ago returned immediately and had not subsided 2 weeks later. Patient received treatment, physical therapy continued for stroke symptoms. AE resulted in doctor or other healthcare professional office/clinic visit, the reported seriousness criterion is disability. Outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/16/2021,01/01/2021,,UNK,LOSARTAN; AMLODIPINE; ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; MONTELUKAST,,"Medical History/Concurrent Conditions: Asthma; Numbness (from stroke 2 years ago); Pain (from stroke 2 years ago); Seafood allergy; Stroke (massive stroke Jul2018, left side effected); Weakness (from stroke 2 years ago)",,,"['Asthenia', 'Hypoaesthesia', 'Neurological symptom', 'Pain']",1,PFIZER\BIONTECH, 1016622,VA,45.0,F,"faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arrival and it was 141/93; chills; low grade fever 100 degrees; This is a spontaneous report from a contactable 45-year-old female other health professional reported for herself that she received 1st dose of bnt162b2 (lot number EL8982) on 15Jan2021 08:00 AM at left arm for Covid-19 immunization. Medical history included hereditary angioedema from unknown date (last episode 2015). The patient had not received other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant drug included caffeine, paracetamol (ACETAMINOPHEN AND CAFFEINE). The patient reported that after waiting the 15 minutes, she walked to her car, and started feeling off. She thought about sitting in the hospital parking lot, but started to drive home. She started to feel dizzy, light headed, faint, dry mouth, hard to swallow so she drove herself to the fire station. They took her blood pressure (BP) upon arrival and it was 141/93 and blood sugar was 90 on 15Jan2021. She was 120 pounds and her normal BP was 116/63. The event onset time was reported as 15Jan2021 08:30 AM. Later on 15Jan2021, the patient had chills and low grade fever 100 degrees. Treatment was received for the events. The events were resolved on unknown date. Events were reported non-serious. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,PVT,ACETAMINOPHEN AND CAFFEINE,,Medical History/Concurrent Conditions: Hereditary angioedema (Last episode 2015),,,"['Blood glucose normal', 'Blood pressure increased', 'Chills', 'Dizziness', 'Dry mouth', 'Dysphagia', 'Feeling abnormal', 'Pyrexia', 'Syncope']",1,PFIZER\BIONTECH, 1016623,,,F,"She has COPD and other health conditions and went to the hospital for a few days after getting the vaccine; This is a spontaneous report from a contactable consumer (reported for her mother-in-law). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the COVID-19 vaccine on 07Jan2021. It was reported that on Jan2021, she has chronic obstructive pulmonary disease (COPD) and other health conditions and went to the hospital for a few days after getting the vaccine. The reporter was where she can get the second dose now, she thinks the date she was supposed to get it has passed. She needed to find out where the second dose can be attained and asked for the number to the local health department for their area. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/07/2021,01/01/2021,,UNK,,,,,,"['Chronic obstructive pulmonary disease', 'Unevaluable event']",1,PFIZER\BIONTECH, 1016624,,,M,"he was bleeding profusely; fell; hurt his hand; This is a spontaneous report from a Pfizer-sponsored program. A male patient (caller's husband) of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at single dose on 24Jan2021 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient got his Covid vaccine on 24Jan2021 and today (26Jan2021) he fell and hurt his hand and he was bleeding profusely. They want to give him a tetanus shot, but caller was not sure if he can get it or not. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/24/2021,01/26/2021,2.0,UNK,,,,,,"['Fall', 'Haemorrhage', 'Limb injury']",UNK,PFIZER\BIONTECH, 1016625,TX,,F,"appendicitis/abdominal pain/fever; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a fever on 26Jan2021. She was having abdominal pain. She went to the emergency room and found out she had appendicitis. On 29Jan2021 (reported as six days after getting vaccine), she had to have emergency surgery and have an appendectomy due to have appendicitis. She mentioned she is following up finding out statistics with CML and appendicitis. She did not regret getting the vaccine, but she wanted to make sure events were reported. Like anything leaded to a hospitalization needed to be noted regardless if it was concluded to be related to the vaccine or excluded from being related. She mentioned she wanted to find out the most accurate up to date information on how many cases of Adverse Event reactions have occurred, related to appendicitis. She wonders if there is a website where she found this information. She did not want to look on internet and find inaccurate information. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported appendicitis with symptoms of abdominal pain and fever is considered related to the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/23/2021,01/01/2021,,UNK,,,,,,"['Abdominal pain', 'Appendicectomy', 'Appendicitis', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1016626,TX,,F,"cirrhosis of the liver; Low platelets; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced low platelets and cirrhosis of the liver on an unspecified date. The outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Hepatic cirrhosis', 'Platelet count decreased']",1,PFIZER\BIONTECH, 1016627,FL,70.0,M,"negative for both in spite of two doses of vaccine; This is a spontaneous report from a contactable Physician (patient). A 70-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration, the second dose on 11Jan2021 (lot number: EL1284) in right arm and the first dose on 21Dec2020 (lot number: EK5730) in left arm, both at single dose for covid-19 immunisation. Medical history included osteoarthritis, diagnosed 10 years prior to the report. Concomitant medications included metformin at 500mg tablet by mouth once daily for longevity (off label); paracetamol (TYLENOL) at two one time and on occasional acetylsalicylic acid (ASPIRIN) at one 325mg tablet on as needed basis. Patient was calling about the COVID vaccine, and he received two doses, and the problem was, he had an IgM and IgG test on 25Jan2021 and he was negative for both in spite of two doses of the vaccine. The outcome of the event was not recovered. Serious criteria for the event was reported as medical significant. The reporter considered the event was unrelated to COVID vaccine, stated it was the exact opposite, it didn't cause anything, which was unfortunate.; Sender's Comments: Event represents an intercurrent medical condition and unrelated to bnt162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/25/2021,14.0,UNK,METFORMIN; TYLENOL; ASPIRIN [ACETYLSALICYLIC ACID],,Medical History/Concurrent Conditions: Osteoarthritis (diagnosed 10 years prior to the report),,,"['Blood immunoglobulin G', 'Blood immunoglobulin M', 'SARS-CoV-2 antibody test negative']",2,PFIZER\BIONTECH, 1016628,FL,,F,"breast cancer; This is a spontaneous report from a contactable consumer reporting for self. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283) via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient said she was recently diagnosed with breast cancer and has been newly prescribed the hormone, Aromasin 25mg. She was scheduled to have her second COVID-19 Vaccine dose on 03Feb2021. She said she has not started the Aromasin 25mg. She said she wanted to check to see if she should hold off on starting the Aromasin 25mg until after she receives her second COVID-19 Vaccine dose, and when would be an appropriate time to start the Aromasin 25mg. Outcome of event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,,,UNK,,,,,,['Breast cancer female'],1,PFIZER\BIONTECH, 1016630,VA,58.0,F,"Atrial fibrillation; palpitations; tachycardia/heart rate 141; This is a spontaneous report from a contactable healthcare professional (HCP). This HCP reported similar events for 2 patients. This is 1st of two reports. This 58-year-old female HCP (patient) reported for herself that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176) on 10Jan2021 at 0.3 mL single by intramuscular injection left arm for COVID-19 vaccination. Medical history included ongoing hypertension and diabetes type 2, both diagnosed about 10 years ago (2011). Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot number: EH9899) on 21Dec2020 at single dose for COVID-19 immunisation. The patient reported that a few days after receiving the 2nd dose (on 14Jan2021), she went into atrial fibrillation and had been having palpitations ever since. She had a cardiology appointment in a few weeks and they started her on apixaban (ELIQUIS). Lab data on 14Jan2021 included EKG: normal sinus and Kardiamobile (a medical grade ECG): it showed tachycardia and at least one other time showed atrial fibrillation, heart rate 141. The outcome of palpitations was not recovered, outcome of other events was unknown. Reporter seriousness for atrial fibrillation and palpitations was medically significant.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of atrial fibrillation cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021111803 same reporter/drug, similar events, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/14/2021,4.0,UNK,,Hypertension (diagnosed about 10 years ago); Type 2 diabetes mellitus (diagnosed about 10 years ago),,,,"['Atrial fibrillation', 'Electrocardiogram abnormal', 'Palpitations', 'Tachycardia']",2,PFIZER\BIONTECH,OT 1016644,IA,87.0,M,"right arm edema, right arm extensive bruising poss DVT",Not Reported,,Not Reported,Yes,,Not Reported,N,02/03/2021,02/09/2021,6.0,PVT,trazodone melatonin,,malignant neoplasm of prostate myeloma Bladder cancer CKD3 DM2 PVD chronic anemia,,cephalexin,"['Contusion', 'Oedema peripheral']",1,MODERNA,IM 1016647,NV,81.0,M,Nausea and vomiting,Not Reported,,Yes,Yes,2.0,Yes,N,01/12/2021,02/02/2021,21.0,PVT,"Meloxicam, Nitroglycerin, Aspirin, Omeprazole, Atenolol","BPH, chronic pain, Lung Carcinoma stable flash remission, Hydonephrosis","BPH, chronic pain, Lung Carcinoma stable flash remission, Hydonephrosis, CABG",,Crab and Penicillin,"['Nausea', 'Oesophagogastroduodenoscopy', 'Vomiting']",2,MODERNA,IM 1016663,AZ,84.0,M,Saturday 01/30/2021 lost peripheral vision. Went to hospital Was given Mri and ultra sound of head and neck stayed until sunday afternoon. Slept Sunday night Now have not been able to sleep at night at all since,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/20/2021,01/30/2021,10.0,PVT,"vitamin c, vitamin D, zinc",Lower back problem (years ),lower back,,None,"['Blood test', 'Insomnia', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging neck', 'Ultrasound scan', 'Ultrasound skull', 'Visual field defect']",1,MODERNA,IM 1016709,MN,93.0,M,"ON 02/08/2021 AROUND 0600 RESIDENTCOMPLAINED OF MOUTH PAIN AND RECEIVED OXYCODONE. DURING THE COURSE OF THE MORNING, RESIDENT EXHIBITED A FEW EPISODES OF LABORED/SHALLOW BREATHING AND SOB AT RESTING. 0XYGEN SATURATION RATE WAS 93-98% ON ROOM AIR, LUNG SOUNDS CLEAR IN ALL LOBES AND PULSE AND TEMPERATURE WITHIN NORMAL RANGE. AS THE DAY PROGRESSED, VITAL SIGNS REMAINED STABLE BUT RESIDENT CONTINUED TO HAVE PERIODS OF SOB/LABORED BREATHING.FAMILY AND NURSE PRACTIONER UPDATED AND THE ORDER WAS RECEIVED TO SEND PATIENT TO MEDICAL CENTER ER FOR EVALUATION PER AMBULANCE. RESIDENT TRANSPORTED AT 1425. RESIDENT RETURNED FROM THE ER AT 1830 ON HOSPICE CARE WITH THE DIAGNOSIS OF: ACURE RESPIRATORY FAILURE WITH HYPOXIA AND END OF LIFE DECISION MAKING. RESIDENT WAS MADE COMFORTABLE AND MONITORED DURING THE NIGHT AND EXPIRED AT 0630 ON 02/09/2021.",Yes,02/09/2021,Not Reported,Yes,,Not Reported,N,02/08/2021,02/08/2021,0.0,SEN,"OXYCONE, LASIX, FLOMAS, CEPHALEXIN,EFFEXOR, EXELON, SEROQUEL, OMEPRAZOLE","ACUTE RESPIRATORY FAILURE, PALLATIVE CARE","ATRIAL FIBRILLATION, ALZHEIMERS, CHARLES BONNET SYNDROME, NON RHEUMATIC MITRAL VALVE DISORDER",,PENICILLIN,"['Death', 'Dyspnoea', 'Dyspnoea at rest', 'Hypopnoea', 'Oral pain', 'Respiratory failure']",2,MODERNA,IM 1016741,TX,60.0,F,"Thrombocytopenia. Bone marrow biopsy on 2/1/2021 showed severe peripheral pancytopenia and acellular marrow space, consistent with aplastic anemia. Patient has received dexamethasone, platelets, and PRBC. Unknown outcome patient has been discharged from the hospital.",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,01/01/2021,01/01/2021,0.0,UNK,"amlodipine-olmesartan, renal vitamin, bystolic, MVI with minerals, synthroid","multiple sclerosis, CKD due to scleroderma renal crisis and malignant htn, thyroid disease",see item 11 please,,PCN and latex,"['Aplastic anaemia', 'Biopsy bone marrow abnormal', 'Packed red blood cell transfusion', 'Pancytopenia', 'Platelet transfusion', 'Thrombocytopenia']",UNK,PFIZER\BIONTECH, 1016770,FL,73.0,M,Patient received 2nd dose of Pfizer vaccine on 2/2/21 and on 2/6/21 he died in his sleep in the a.m. No other signs or symptoms were observed prior to death.,Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/06/2021,4.0,OTH,Dilantin 300mg Aspirin 81mg Atorvastatin 40mg Levothyroxine 100mcg Ferrous Sulfate 325mg Symbicort 160/4.5mcg inhaler Ventolin 90mcg inhaler Calcium 600mg Latanoprost eye drops,None,"Fahr syndrome, Dementia, hypercholesteremia, metabolic encephalopathy, syncope, hypothyroidism, seizures, Coronary Artery Disease, iron deficiency anemia, asthma, ataxia.",,No known allergies,['Death'],2,PFIZER\BIONTECH,IM 1016772,NY,39.0,F,"Patient is a 39-year-old white female with a PMH of depression, anxiety, migraine and chronic sinusitis. She has NKDA. Her medications prior to event included alprazolam 0.25mg Qday, citalopram 20mg, 1 and � tabs Qday, Topamax 25mg, 3 tabs Qday and Zyrtec 10mg Qday. She was administered her first dose of the Pfizer COVID vaccine on 1/21/21 at 1:30pm. She presented to the hospital on 1/22/21 @ 9:45am with acute onset of right sided weakness (she is a teacher who collapsed in her classroom without LOC) and was found to have a intraparenchymal hematoma (IPH) in the left posterior paramedian frontal lobe measuring up to 2.9 x 1.8 x 3.4cm with surrounding vasogenic edema and mild local mass effect with no underlying mass lesion or vascular malformation on MRI. She stated that she has had intermittent headaches over the last few weeks not similar to her prior migraines, although with no neuro deficits. She was also noted to have a urine tox screen positive for amphetamines. There is a confirmatory test pending. She was discharged to acute rehab on 1/25/21. Patient is still recovering from the adverse event. She did not receive any other vaccines within a month prior to the event.",Not Reported,,Yes,Yes,3.0,Yes,Y,01/21/2021,01/22/2021,1.0,PUB,"alprazolam 0.25mg Qday, citalopram 20mg, 1 and � tabs Qday, Topamax 25mg, 3 tabs Qday and Zyrtec 10mg Qday",Headache,"Depression, anxiety, migraine and chronic sinusitis",,NKDA,"['Cerebral haematoma', 'Headache', 'Hemiparesis', 'Magnetic resonance imaging brain abnormal', 'Syncope', 'Urine amphetamine positive', 'Vasogenic cerebral oedema']",1,PFIZER\BIONTECH,IM 1016778,SC,19.0,M,"I received my first vaccine as the Pfizer manufacturer, and did not have any side effects. However, when I received my 2nd shot, I received the Modena manufacturer, and have experienced many concerning side effects. Fever, cold chills, trembling, fatigue, that lasted 2 days after the vaccine was administered. The side effect I am still experiencing is a metallic taste in my mouth, that gets worse when I drink water or other beverages. My hands and fingers turned a rust orange color the day after getting the shot and resolved within 48 hours.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/01/2021,02/02/2021,1.0,PHM,Fluoxetine 40mg Lamotrigine 100mg Amlodipine 10mg Lunesta 3mg,none,Anxiety,,codeine,"['Chills', 'Dysgeusia', 'Fatigue', 'Pyrexia', 'Skin discolouration', 'Tremor']",2,MODERNA,SYR 1016785,NC,81.0,M,"profound dizziness, work up for stroke plaque on arm",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/29/2021,02/03/2021,5.0,PVT,losartan,none,none,swellings of lips age 70 flu extra strength vaccine,no,"['Dizziness', 'Laboratory test normal', 'Skin plaque']",2,PFIZER\BIONTECH,IM 1016793,KY,93.0,F,"1st dose vaccine 1/30/2021; fall of unknown etiology at home on 2/1/21; went to urgent care 2/1/21 for back pain, sent to ED same day for eval; admitted to hospital on 2/1/21 from ED for T12 compression fracture.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/30/2021,02/01/2021,2.0,PVT,"Norvasc, aspirin, synthroid, lisinopril",,"Hyperthyroidism, Arthritis, HTN, Breast Cancer 1985",,Penicillins,"['Back pain', 'Compression fracture', 'Fall']",1,PFIZER\BIONTECH,IM 1016827,WI,67.0,F,"History of Present Illness: Patient is a(n) 67 Y female with a PMH of asthma, HTN, HLD, GERD who arrived to the ED via rescue squad with complaints of sudden onset of squeezing chest pain/tightness that radiated to the back, associated dyspnea, lightheadedness and dizziness that began around 6:30PM. Pt reports she was feeling well prior to the episode and she had her COVID 19 vaccine at 4:30PM and had tolerated the vaccine well. She does report that she had atrial fibrillation before, about 5 years ago and she underwent a cardiac work up. She denied palpitations, fever, chills, body aches, nausea, or vomiting. She does have a non productive cough. Her BP normally runs 130/80's at home and is controlled w amlodipine. She was given SL nitro and aspirin in the ambulance. EKG showed atrial fibrillation with RVR, HR 150's. Reason for admission: Atrial fibrillation with rapid ventricular response (*) Atrial fibrillation with RVR (*) She was admitted for further evaluation and monitoring. Troponin level noted to be 0.79 and EKG with ST-T wave changes, cardiology was consulted and patient underwent cardiac cath who revealed no significant CAD hyperdynamic LVEF 70 %. She developed a small hematoma post catheterization which has resolved. Cardizem was switched to metoprolol and both BP and HR are improved and controlled with losartan. Pt without any adverse effects to losartan, no s/s angioedema. Afib with an abrupt onset and abrupt return to normal sinus rhythm. She complained of calf pain, US dopplers were obtained and were negative for DVT. Her D Dimer was also normal. Pt discharge to home in stable condition.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/27/2021,01/27/2021,0.0,PVT,"Home Meds: acetaminophen (TYLENOL) 500 MG tablet Take 500-1,000 mg by mouth one time daily. amLODIPine (NORVASC) 5 MG tablet Take 1 tablet (5 mg total) by mouth daily. Ascorbic Acid (VITAMIN C) 500 MG CAPS Take 500 mg by mouth 2 times",,"Acute bronchitis o Osteopenia o GERD (gastroesophageal reflux disease) o Hyperlipidemia o Hypertension o Never smoked cigarettes o Obesity o OSA on CPAP o ANA positive o Candidiasis, intertrigo o Asthma o Primary osteoarthritis involving multiple joints o Encounter for annual wellness exam o Paresthesias o Gait abnormality o Memory loss o Arterial ischemic stroke, chronic o Dyspnea and respiratory abnormalities o Urinary incontinence o Atrial fibrillation with RVR (*)",,"Ace Inhibitors-angioedema o Bac-polym-Neo-HC- edema sulfa-pruritus, N/V","['Alanine aminotransferase normal', 'Antinuclear antibody positive', 'Aspartate aminotransferase normal', 'Atelectasis', 'Back pain', 'Blood albumin normal', 'Blood alkaline phosphatase increased', 'Blood bilirubin normal', 'Blood calcium normal', 'Blood chloride increased', 'Blood creatinine normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea normal', 'Cardiomegaly', 'Catheterisation cardiac abnormal', 'Chest X-ray abnormal', 'Chest discomfort', 'Chest pain', 'Cough', 'Dizziness', 'Dyspnoea', 'Electrocardiogram ST-T change', 'Fibrin D dimer normal', 'Haematocrit normal', 'Haematoma', 'Haemoglobin normal', 'Hyperdynamic left ventricle', 'International normalised ratio normal', 'Pain', 'Pain in extremity', 'Platelet count normal', 'Protein total increased', 'Prothrombin level normal', 'Red blood cell count normal', 'Troponin increased', 'Ultrasound Doppler normal', 'White blood cell count increased']",1,MODERNA,IM 1016880,AR,71.0,M,"Pt was vaccinated on 1/21/21. Presented to ED on 1/23/21 after stroke like symptoms that started at 7:30am. Symptoms resolved over the morning, admitted to hospital for observation, MRI confirmed small infarct R central gyrus, consistent with symptoms. Started on plavix, continued on aspirin.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/21/2021,01/23/2021,2.0,PVT,ASA 81mg Amlodipine 5mg Atorvastatin 10mg Losartan 100mg Levothyroxine 88mcg,None,HTN - well controlled HLD - controlled Hypothyroidism - well controlled,,NKDA,"['Cerebral infarction', 'Magnetic resonance imaging abnormal', 'Neurological symptom']",UNK,PFIZER\BIONTECH, 1016907,MD,92.0,F,"Resident coughing in dining room, staff suctioned, physician stated to transfer via 911 to hospital, 6:33 PM. Hospital notified Nursing Home staff resident passed away at 8:25 PM. No adverse reaction noted to the Covid vaccine 24 hours after each dose at Nursing Home. There was no airway obstruction, cardiorespiratory arrest, death was natural at hospital.",Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/30/2021,9.0,SEN,"acetaminophen, aspirian, bisacodyl, buspirone, celebrex, cetaphil, levothyroxine, isoartan, MOM, miralax, mult vit, namenda, nizoral, remeron, senna plus.",,"acute respiratory disease, unspecified dementia, weakness, hx of falling, ostearthritis, hypothyroidism, unsteady on feet, cognitive communication deficit, expressive long. disorder, anxiety, hypertension.",,KNA,"['Cough', 'Death']",1,PFIZER\BIONTECH,IM 1016986,MN,83.0,M,"Increased weakness, confusion. All occured after surgery but was doing well postoperatively until 2nd dose given 2/4/2021 Then became confused, weak and unable to care for self.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/04/2021,02/05/2021,1.0,PVT,"Colace, Eliquis, Miralax, Tramadol, Zoloft, Metoprolol, Zocor, Calcium, Vit D, MTV","Lower GI bleed, Shoulder replacement done 02/01/2021","Osteoarthritis, PVC's, Depression, Hypertension, Hyperlipidemia, Malignant Melanoma, Chronic Apixaban therapy, Paroxysmal Afib,",,"Oxycodone, PCN","['Asthenia', 'Blood culture', 'Blood lactic acid', 'Brain natriuretic peptide', 'Chest X-ray', 'Computerised tomogram head', 'Confusional state', 'Electrocardiogram', 'Full blood count', 'Impaired self-care', 'Metabolic function test', 'Troponin', 'Urine analysis', 'X-ray limb']",1,MODERNA,SYR 1016994,MT,80.0,F,Pt. received vaccination on 2/6. On 2/7 pt stated she was fine. On 2/8 daughter found her in the evening unable to speak. She was brought to the ED.,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/06/2021,02/08/2021,2.0,PVT,"Tylenol, amlodipine, zyrtec, Colace with senna, Fish oi, Furosemide, gabapentin, Glucosamine, Hydrocodone/acetaminophen, meloxicam, metaxalone. montelukast, Multivitamin, Occuvite, omeprazole, zoloft, trazadone",CHF,"hypertension, hyperlipidemia, diverticulitis, asthma, osteoarthritis",,"tape, prednisone","['Angiogram', 'Aphasia', 'Cerebral ischaemia', 'Computerised tomogram normal', 'Magnetic resonance imaging abnormal']",1,MODERNA,IM 1017011,NY,67.0,F,Resident expired 01/26/21 at 5:25am.,Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/26/2021,4.0,SEN,,Dialysis,Chronic Kidney Failure Respiratory Failure,,NKA,['Death'],1,PFIZER\BIONTECH,IM 1017020,FL,84.0,F,left side weakness of both upper and lower extremity. start about a week ago,Not Reported,,Not Reported,Yes,5.0,Not Reported,U,01/22/2021,02/03/2021,12.0,PVT,"possibly : Albuterol, allopurinol, brovana, aspirin, lipitor, probiotics, carbamazepine, plavix, aricept, synthroid, meclizine, metoprolol tartrate, fiber tabs",none,"Acute gout Allergic rhinitis Alzheimer's disease Anxiety and depression COPD (chronic obstructive pulmonary disease) Diabetic neuropathy, type II diabetes mellitus Dyslipidemia Fatty liver Generalized osteoarthritis GERD (gastroesophageal reflux disease) HTN (hypertension) Hypothyroidism MGUS (monoclonal gammopathy of unknown significance) Osteoporosis",,"benadryl, contrast dye, eluxadoline, levaquin, lyrica, percocet","['Hemiparesis', 'Magnetic resonance imaging']",1,MODERNA,ID 1017051,,77.0,M,"pt received vaccine on 2/3. early on 2/4 developed chest pain, dyspnea, and was seen in ED and diagnosed with acute exacerbation of CHF and NSTEMI type 2, and anemia. on 2/5 transfusion was started and pt developed worsening dyspnea and then PEA arrest. Pt achieved ROSC and was transferred to the cardiac intensive care unit where he required vasopressor support. he subsequently declined and died on 2/7",Yes,02/07/2021,Not Reported,Yes,,Not Reported,N,02/03/2021,02/04/2021,1.0,UNK,,,"coronary artery disease with prior two-vessel CABG in 2006, Ischemic cardiomyopathy, hypertension, hyperlipidemia, bilateral carotid artery disease, paroxysmal atrial fibrillation, systolic heart failure, pulmonary hypertension, and moderate -severe aortic stenosis, ulcerative",,,"['Acute myocardial infarction', 'Anaemia', 'Cardiac failure congestive', 'Cardio-respiratory arrest', 'Chest pain', 'Death', 'Dyspnoea', 'Intensive care', 'Pulseless electrical activity', 'Transfusion', 'Vasopressive therapy']",UNK,MODERNA, 1017074,TN,,M,"Pneumonia on both lungs; A report was received from a consumer who was an 87 year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the serious adverse event pneumonia on both lungs. The patient's medical history was not provided. Concomitant medications reported included carvedilol, digoxin, furosemide, lisinopril, simvastatin, codeine phosphate hemihydrate/paracetamol, testosterone, acetylsalicylic acid, and multivitamins. On 02 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient reported receiving the first dose of Moderna Covid-19 vaccine on 02 Jan 2021. On 04 Jan 2021, he was having a very difficult time breathing. He went to the doctor on 06 Jan 2021 and found out he had pneumonia on both lungs and was positive for COVID-19. He was treated by the doctor. Treatment for the event included antibiotics, 1 week of steroids, and a bamlanivimab injection on 11 Jan 2021. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, pneumonia on both lungs, was unknown/not reported.; Reporter's Comments: This spontaneous report concerns an 87-year-old male patient serious adverse event pneumonia on both lungs. The event occurred 5 days after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: 025L20A, expiration date-unknown). Treatment administered included antibiotics, steroids and bamlanivimab injection, and outcome was unknown. Although a temporal association exist, there is not enough information to adequately assess the causal association between the reported event and mRNA-1273 vaccine administration. Critical details such as diagnostic test for COVID infection prior to vaccination was not established or ascertained. Causality is also confounded by the patient's advanced age. Main field defaults to �possibly related'",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/06/2021,4.0,UNK,CARVEDILOL; DIGOXIN; FUROSEMIDE; LISINOPRIL; SIMVASTATIN; ALTERMOL; TESTOSTERONE; ASPIRIN [ACETYLSALICYLIC ACID]; MULTIVITAMINS [VITAMINS NOS],,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['COVID-19', 'Dyspnoea', 'Pneumonia', 'SARS-CoV-2 test positive']",1,MODERNA,OT 1017076,NC,25.0,F,"Paralyzed on the right side down to her foot; Numbness in her hands and feet; Slurred speech; Felt really heavy in her face area, hurt really bad; Shooting pain; Feels tingly; Felt really heavy in her neck, hurt really bad; unable to walk; A spontaneous report was received from a consumer who was also a 25-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly, unable to walk and shooting pain feelings. The patient's medical history was not provided. Concomitant product use was not provided. On 21 Jan 2021, approximately two hours prior to the start of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. Approximately two hours after receiving the vaccine at 12:30 pm, the patient experienced heavy feeling in her neck and face area that hurt really bad. Later, she noticed numbness in her hands and feet. Slurred speech was reported from a bystander. By 3:30pm, the patient was completely paralyzed on her right side. She was taken to the hospital, and a code stroke was initiated; however, all labs were normal. On 26 Jan 2021, the patient was still paralyzed on her right side, unable to walk, had shooting pain feeling, and two fingers on her right hand were able to move but still felt tingly. The doctors planned to discharge her on the next day to a rehab center because she could not function alone. Treatment for the event included pain medication and hospitalization. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, developed heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly, unable to walk and shooting pain feelings were considered unknown.; Reporter's Comments: A spontaneous report concerns a 25-year-old, female, patient, who experienced heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly and shooting pain feelings. The events of heavy feeling in her neck and face area, numbness in her hands and feet, slurred speech, completely paralyzed on her right side occurred on the same day after the administration of the first dose of mRNA-1273 (Lot number 032L20A, expiration date unknown). The events of inability to walk, had shooting pain feeling and two fingers on her right hand were able to move but still felt tingly occurred the following day after the vaccine administration. Treatment included pain medication and outcome is unknown. Based on the information provided, which indicates a strong temporal association between the reported events and administration of mRNA-1273 vaccine (onset latency of 2 hours), a causal association cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/21/2021,01/21/2021,0.0,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No adverse event, Continue: [UNK], Comment: No reported medical history.",,,"['Discomfort', 'Dysarthria', 'Facial pain', 'Gait inability', 'Hemiplegia', 'Hypoaesthesia', 'Laboratory test normal', 'Neck pain', 'Pain', 'Paraesthesia']",1,MODERNA,OT 1017077,CO,35.0,F,"Severe arm rash the size of a baseball welt; Muscle pain; Had a fever for five days; Severe leukopenia; Could not walk; A spontaneous report was received from a pharmacist who was a 35-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe leukopenia, had a fever for five days, muscle pain, could not walk, and severe arm rash the size of a baseball welt. The patient's medical history was not provided. No concomitant medication use was reported. On 22 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date in Jan 2021, the patient's white blood cell count decreased which was considered severe leukopenia. Additionally, she experienced a fever for five days that would not decrease with paracetamol or ibuprofen, had muscle pain, and could not walk. On 25 Jan 2021, the patient had a severe arm rash the size of a baseball welt. Treatment for the arm rash included diphenhydramine. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events, severe leukopenia, had a fever for five days, muscle pain, could not walk, and severe arm rash the size of a baseball welt, was unknown.; Reporter's Comments: This case concerns a 35-years-old female patient, who experienced a serious unexpected event of leukopenia, a non-serious unexpected event of gait disturbance, rash and non-serious expected event of myalgia, and pyrexia. The event of rash occurred on day 4 after first dose of mRNA-1273, lot # unknown. Remaining events occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Laboratory tests revealed severe leukopenia (details not provided). Treatment included Tylenol, Ibuprofen and Benadryl. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Gait inability', 'Leukopenia', 'Myalgia', 'Pyrexia', 'Rash', 'Urticaria', 'White blood cell count decreased']",1,MODERNA,OT 1017079,CA,,U,"Fainted; Had a seizure; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fainted and had a seizure. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, after vaccine administration, the patient fainted and had a seizure. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events, fainted and seizure, were unknown.; Reporter's Comments: This case concerns a patient, who experienced events of fainted and seizure. The events occurred the same day after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,01/23/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Seizure', 'Syncope']",1,MODERNA,OT 1017080,,,F,"fainted; body aches; fever; Chills; A spontaneous report was received from a consumer who is a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fainting, body aches, fever and chills. The patient's medical history was not provided. Concomitant medications were not reported. On 26 Jan 2021, the patient received their second dose of two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient experienced body aches, fever and chills and she got up in the middle of the night and fainted. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events fainting, body aches, fever and chills, were considered not resolved.~; Reporter's Comments: This case concerns a female patient, who experienced events of fainting, body aches, fever and chills. The events occurred the same day after the second and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Chills', 'Pain', 'Pyrexia', 'Syncope']",2,MODERNA,OT 1017081,,,M,"Difficulty breathing/ shortness of breath; Tested positive for COVID-19; Pain; Not feeling well / very sick; Vaccine is defective; Bad headache; Fever; A spontaneous report was received from a consumer concerning a 65-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced bad headache, pain, fever, not feeling well, difficulty breathing/ shortness of breath, and tested positive for COVID-19. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 14 Jan 2021, approximately two to three days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 04L20) intramuscularly for COVID-19 infection. On unknown date, the patient experienced a bad headache, pain, fever and was still not feeling well. Patient went to emergency room and had difficulty breathing, shortness of breath and ended up receiving an infusion of casirivimab imdevimab. Patient tested positive for COVID-19 as well. Treatment for the event included casirivimab/ imdevimab. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, bad headache, pain, fever, not feeling well, difficulty breathing/ shortness of breath, and tested positive for COVID-19, was unknown.; Reporter's Comments: A spontaneous report concerns a 65-years-old, male patient who experienced the unexpected serious event difficulty breathing/ shortness of breath bad and non-serious events of headache, pain, fever, not feeling well and tested positive for COVID-19. The events occurred approximately two to three days after administration of mRNA-1273 vaccine (Lot number 04L20). Treatment provided included casirivimab/imdevimab and outcome of the events is unknown. Based on the known information about COVID and duration to diagnosis, it is very unlikely to be associated with the vaccine administration. The other events are temporally associated with the administration of mRNA-1273, a causal relationship cannot be excluded. Headache and fever are consistent with the known safety profile of the vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['COVID-19', 'Dyspnoea', 'Headache', 'Infusion', 'Malaise', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA,OT 1017083,,71.0,M,"Pneumonia; coughing up blood; A spontaneous report was received from a consumer who was also a 71-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pneumonia and coughing up blood. The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported. On 19 Jan 2021, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient began to cough up blood and was seen and treated by a healthcare professional. A chest x-ray was done and revealed pneumonia. Treatment for the event included doxycycline, prednisone and an inhaler. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, pneumonia and coughing up blood, were unknown.; Reporter's Comments: This case concerns a 71-year-old male subject, who experienced a serious unexpected event of Pneumonia, and non-serious unexpected event of Hemoptysis. The events occurred one day after the first dose of the mRNA-1273 administration. Treatment for the event included doxycycline, prednisone and an inhaler. Since Pneumonia has insidious onset rather than acute onset, the event was possibly related to underlying condition confounded by elderly age of patient. Very limited information regarding these events have been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event of Pneumonia and Hemoptysis, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,01/20/2021,1.0,UNK,,,Medical History/Concurrent Conditions: COVID-19 (was hospitalized),,,"['Chest X-ray abnormal', 'Haemoptysis', 'Pneumonia', 'SARS-CoV-2 test negative']",1,MODERNA,OT 1017087,TN,52.0,F,"lips became numb; throat started to sound very scratchy and itchy; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 22Jan2021 at 16:15 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, hypertension, morbid obesity, anemia, arthritis, allergic to fish (shell & fin) and all nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, but it was reported that the patient took other medications within 2 weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 22Jan2021, at 16:15 (also reported as after 15 minutes), the patient's lips became numb and the throat started to sound very scratchy and itchy. This resulted in a doctor or other healthcare professional visit. Treatment for the events included the patient taking her own diphenhydramine (BENADRYL), epinephrine (EPIPEN) and albuterol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of lips became numb and the throat started to sound very scratchy and itchy was resolved with sequel on Jan2021. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,PUB,,,Medical History/Concurrent Conditions: Allergy to nuts; Anemia; Arthritis; Asthma; Fish allergy; Hypertension; Morbid obesity; Shellfish allergy,,,"['Hypoaesthesia oral', 'Throat irritation']",UNK,PFIZER\BIONTECH, 1017089,NY,71.0,M,"walking is still very bad; lower back pain; he reported lower back pain, that has migrated more to the right hip and into the glute; he reported lower back pain, that has migrated more to the right hip and into the glute; it might be kidney pain; arm pain; This is a spontaneous report from a contactable other Health Professional (HCP). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3302), intramuscular on 22Jan2021 15:10 at 0.3 mL, single (0.3ml by intramuscular injection left shoulder) for COVID-19 prophylaxis. Medical history included ongoing high blood pressure (diagnosed about 21 years ago), ongoing gout (Diagnosed about 2 years ag), ongoing ankle spur right foot, ongoing diminished cartilage both knees, joint pain. The concomitant medications included torsemide. The patient reported adverse event (AE) after his first Pfizer-Biontech covid19 vaccine at 15:10 on 22Jan2021. He reported arm pain starting 3 hours after vaccination until noon the next day (23Jan2021). When he woke up on 23Jan2021 he reported lower back pain, that has migrated more to the right hip and into the glute. The pain inhibits walking, standing, etc. He did note that he is >300lbs and has had joint pain in the past, but the hip pain is new. He also thought it might be kidney pain, as he takes a daily diuretic. He stated he has been treating with Aleve twice a day, but that walking is still very bad. The patient is an optometrist that was calling about the Covid-19 vaccine and said that he did not know if the Lot number written on the vaccination card is EL3302, E13302, or EI3302. He got the vaccine on 22Jan2021 and reported that he got a sore arm about 3 hours after receiving the injection. He woke up with a sore lower back pain. He is 5ft 9.5 and 310 lbs and he is on Torsemide, a pretty strong diuretic. He woke up with the back pain and stated that it moved right and middle to his buttocks, a little lower than the end of his spine and to the right. He did not think it was his kidneys. He said that Torsemide can make kidneys work overtime. His knees were pretty shot, the left worse than the right. No further details provided. He was upset to know that he has shrunk a 1.5 inches over the years. He has been taking 2 Aleve a day since Saturday, this morning was his 4th pill. He said that it is really odd when he stands equally on both feet his lower back hurts. He has to sleep on his right side and that it hurts more when he sleeps on his back and on his left side. He was fearful doing eye exams next to his patient and how the lower back pain would affect him. Reporter considered seriousness for Lower back pain was Medically significant. The outcome of event lower back pain was not recovered; of event arm pain was recovered on 23Jan2021; of other events was unknown.; Sender's Comments: Based on the time association, the possible contribution of suspect vaccine BNT162B2 to the event low back pain cannot be excluded. The ongoing gout and concomitant drug torsemide may also play contributory roles to the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,UNK,TORSEMIDE,Blood pressure high (diagnosed about 21 years ago); Cartilage damage (Diminished cartilage both knees); Gout (Diagnosed about 2 years ago); Heel spur syndrome (Ankle spur right foot),Medical History/Concurrent Conditions: Joint pain,,,"['Arthralgia', 'Back pain', 'Body height decreased', 'Dysstasia', 'Fear', 'Gait disturbance', 'Musculoskeletal pain', 'Pain in extremity', 'Renal pain', 'Sleep disorder']",1,PFIZER\BIONTECH,OT 1017091,FL,65.0,M,"severe shaking convulsive; chills; nausea; leg cramps; difficulty breathing; vomitting; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received single dose of BNT162B2 (PFIZER, Solution for injection, batch/lot number and exp date not reported ), via an unspecified route of administration (vaccine location: left arm) on 22Jan2021 10:45 for COVID-19 immunization. Medical history included diabetes and high cholesterol. The patient did not have Covid prior vaccination. The patient had no known allergies. Concomitant medication/other medications within two weeks included rosuvastatin calcium (CRESTOR), telmisartan, empagliflozin, metformin hydrochloride (SYNJARDY), and atenolol. There was no other vaccine within four weeks. On 24Jan2021 02:00, the patient experienced severe shaking convulsive, chills, nausea, leg cramps, difficulty breathing, and vomiting. No treatment was received for the events. The patient was not Covid tested post vaccination. The patient recovered from the events on an unspecified date in Jan2021. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/24/2021,2.0,UNK,TELMISARTAN; SYNJARDY; ATENOLOL; CRESTOR,,Medical History/Concurrent Conditions: Diabetes; High cholesterol,,,"['Chills', 'Dyspnoea', 'Muscle spasms', 'Nausea', 'Seizure', 'Tremor', 'Vomiting']",1,PFIZER\BIONTECH, 1017092,GA,78.0,F,"little depressed; not feeling like herself; weak; tired; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140 and expiry date unknown), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient received the first dose on the left arm on 19Dec2020 10:30 (lot number: EL0140). Medical history included hypertension. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no side effects after the first vaccine except for a little tenderness which went away. On 11Jan2021, after receiving the second dose, she felt really tired but which went away. On 20Jan2021 (last Wednesday), she started to feel tired, weak, and not feeling like herself. On 22Jan2021, the patient was a little depressed. She did not have a headache. Her blood pressure was fine and she never had a fever. She had an X-ray back in Sep2020. Her vision is good. She is not hurting anywhere. She doesn't feel as strong. She doesn't understand the tiredness, weakness, and depression. Outcome of the event tired was recovered on 11Jan2021, of the events doesn't feel like herself and weak was not recovered, and of the event depression was recovering. The reporter assessed all the events as related to the bnt162b2. The events depression and doesn't feel like herself were reported as serious: medically significant while the other events were reported as non-serious.; Sender's Comments: A possible contributory role of bnt162b2 in triggering the onset depression and doesn't feel like herself cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/11/2021,2.0,PUB,,,Medical History/Concurrent Conditions: Hypertension,,,"['Asthenia', 'Depression', 'Fatigue', 'Feeling abnormal']",2,PFIZER\BIONTECH, 1017093,WV,22.0,F,"swollen eyes; a rash on her forehead , around her eyes and both cheeks; very itchy eyes; This is a spontaneous report from a contactable Nurse (patient's mother). A 22-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 06Jan2021 17:30 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Nurse stated her daughter received her first Pfizer vaccine on 06Jan2021 around 5:30 pm. The patient's signs and symptoms began shortly after receiving the shot. That evening at 19:00, she had very itchy eyes, the next morning (07Jan2021) she woke up with swollen eyes, a rash on her forehead, around her eyes and both cheeks. She took benedryl and zyrtec on 07Jan2021. The symptoms clear up by 10Jan2021, following a visit to her HCP, on 08Jan2021. She received a steroid shot, a prednisone dose pack her HCP. Her HCP recommended she not take dose 2 and instructed her mother to call Pfizer for recommendations. The outcome of the events was recovered on 10Jan2021. The reporting nurse considered the case as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: The reported events of swollen eyes, itching eyes and rash on face were likely related to first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), due to plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,UNK,,,,,,"['Eye pruritus', 'Eye swelling', 'Rash']",1,PFIZER\BIONTECH, 1017095,OR,30.0,F,"tingling with pins and needles feeling all through arms, legs, face; nausea; dizziness sight; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on the left arm on 21Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included ""Celtics disease"", allergies to gluten and negative COVID-19 test nasal swab on 10Oct2020. Concomitant medication included birth control and prenatal vitamin. Patient did not have COVID prior to vaccination and was not pregnant. Vaccination was received in the hospital and no other vaccine was received four weeks prior. On 21Jan2021 16:00, the patient reported nausea, dizziness sight and chills were normal then she had tingling with pins and needles feeling all through arms, legs, face. She still had prickling feeling in arms and her left foot was tingling and it had been four days later. The adverse events pins and needles reportedly resulted in disability or permanent damage. Patient has been tested for COVID post-vaccination on an unspecified date with unknown results. Treatment was received for the events. Outcome of the events was not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of prickling feeling in arms and her left foot tingling cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Yes,N,01/21/2021,01/21/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Celiac disease; COVID-19 virus test negative (nasal swab); Gluten sensitivity,,,"['Chills', 'Dizziness', 'Nausea', 'Paraesthesia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1017096,CA,83.0,F,"pain in my chest/stomach; pain in my chest/stomach; she couldn't sleep last night at all she was awake all night; had strange visions flashing in my head while trying to sleep; acid reflux/burping up acid; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: TL9261, expiration date not provided), via an unspecified route of administration on 25Jan2021 16:30 at a single dose for COVID-19 immunization. The patient has no medical history and there were no concomitant medications. On 25Jan2021, the patient experienced having acid reflux, pain in her chest/stomach that lasted all night last night and was worse when lying down. When she burped, it relieved some pressure. She had strange visions flashing in her head while trying to sleep on 25Jan2021. The patient was wondering if she was having a reaction from the vaccine. On 25Jan2021, after over an hour after the vaccine, she started having severe pain in the chest and stomach area and she couldn't sleep last night at all. She was awake all night, burping up acid. She was wondering if those were reaction to the vaccine, should she go see her doctor or what should she do about that. She got her first dose on 25Jan2021 and she started having chest and stomach pain the same day at about 6 PM. She was burping acid all night and early in the morning of 26Jan2021 and she was having these strange things like pictures going to her head that were weird. She was not sleeping but they were strange images, they were strange, they weren't normal. She says with that added in it sounds crazy. She has her vaccine card that says she should get the next one 15Feb2021. She wanted to avoid catching the corona. She had drank acid yesterday and she was wondering if that was causing her to have acid reflux. She clarified that she drank a lot of acidic liquids on 25Jan2021 and she was wondering if that might have had something to do with it, like orange juice and cranberry juice so she is wondering did that have anything to do with it, the acidity maybe made her stomach have acid reflux because she has had that in the past. She asked if she should go to the doctor. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/25/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Abdominal pain upper', 'Chest pain', 'Eructation', 'Gastrooesophageal reflux disease', 'Hallucination, visual', 'Sleep disorder']",1,PFIZER\BIONTECH, 1017098,FL,78.0,M,"Edema of glottis; General malaise / indisposition; nausea; dizziness; body pain; pain in the joints; swelling of the throat; high pressure; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: El9263) solution for injection, via an unspecified route of administration in left arm on 23Jan2021 09:15 at a single dose for Covid-19 immunization. Medical history included high blood pressure, and diabetes. Concomitant medications included losartan, metformin, and simvastatin. The patient experienced edema of glottis, general malaise, nausea, dizziness, body pain, pain in the joints, indisposition, swelling of the throat, and high pressure; all on 24Jan2021 21:00. Patient visited the physician and received treatment for the adverse events (general examination). The patient was not diagnosed with Covid-19 prior to vaccination. Patient has not been tested for Covid-19 since the vaccination. Outcome of the events was recovering. No follow-up activities are needed. Information regarding the batch/lot number has been obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/24/2021,1.0,UNK,LOSARTAN; METFORMIN; SIMVASTATIN,,Medical History/Concurrent Conditions: Blood pressure high; Diabetes,,,"['Arthralgia', 'Blood pressure increased', 'Dizziness', 'Illness', 'Laryngeal oedema', 'Malaise', 'Nausea', 'Pain', 'Pharyngeal swelling']",1,PFIZER\BIONTECH, 1017099,IL,57.0,M,"Diplopia due to left 6th (abducen) cranial nerve palsy; Diplopia due to left 6th (abducen) cranial nerve palsy; This is a spontaneous report from a contactable physician. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), intramuscular, in the left arm, on 05Jan2021 07:30 at a single dose for covid-19 immunization. Medical history included type 2 diabetes. Concomitant medications were unspecified. The patient took unspecified medications in two weeks. The patient did not have any other vaccine in four weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. The patient had no known allergies. On 07Jan2021, the patient experienced diplopia due to left 6th (abducen) cranial nerve palsy. The event resulted in doctor office/clinic visit, and emergency room visit. Therapeutic measure was taken as a result of the event which included fresnel prism on current glasses to alleviate diplopia. Outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported diplopia due to left 6th (abducen) cranial nerve palsy and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/07/2021,2.0,UNK,,,Medical History/Concurrent Conditions: Type 2 diabetes mellitus,,,"['Diplopia', 'Eyeglasses therapy', 'VIth nerve paralysis']",UNK,PFIZER\BIONTECH,OT 1017101,GA,46.0,F,"Tip of tongue feels slightly enlarged; Salty taste in mouth; Tingle sensation on tip tongue; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3302), via an unspecified route of administration on 22Jan2021 08:00 at single dose on the right arm for COVID-19 immunization. Medical history included high blood pressure and COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications included amlodipine and ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) received within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 12:00, the patient experienced salty taste in mouth for over 2days. Tingle sensation on tip tongue. Tip of tongue feels slightly enlarged. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No treatment received for the adverse event. Outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,PVT,AMLODIPINE; LO LOESTRIN FE,,Medical History/Concurrent Conditions: Blood pressure high; COVID-19,,,"['Dysgeusia', 'Paraesthesia oral', 'Swollen tongue']",1,PFIZER\BIONTECH, 1017102,FL,,M,"eye infection; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (wife) reported that a male patient of an unspecified age received the first dose of bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller reported that her husband received the 1st dose of the Pfizer vaccine 2 weeks ago (Jan2021) and he had an eye infection unrelated to the vaccine. Caller was asking if he can take antibiotics and asking if that would be contraindicated with the vaccine that he got. Caller also mentioned that her husband was afraid to take antibiotics and wanted to know if it was okay to take antibiotics which was prescribed by his Doctor. Her husband was also an healthcare professional but he was an Orthopedic Surgeon and it's not his field. The reported wanted to know if that would reduce the immunity that he got from the vaccine. The patient developed the eye infection a week ago (Jan2021). He had not taken the antibiotic before. Second dose would be on 01Feb2021. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The eye infection is most likely an intercurrent condition and unrelated to suspect vaccine BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,['Eye infection'],1,PFIZER\BIONTECH, 1017103,FL,,F,"reaction for 14 days. She went to dermatologists to check about those marks if it's cancerous or something/did a biopsy; she's not feeling well; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 at SINGLE DOSE for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient got her 1st dose of Covid 19 Vaccine on 11Jan2021 and now already experiencing a reaction for 14 days. She went to dermatologists to check about those marks if it's cancerous or something, she was there 4days ago and did a biopsy, then after that Doctor asked if she took the covid 19 vaccine because they knew about it. She wanted to ask as well if it's Okay if she will not take the 2nd dose because she's not feeling well now and can't take it. The outcome was unknown. Information about Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/01/2021,,UNK,,,,,,"['Biopsy skin', 'Malaise', 'Skin reaction']",1,PFIZER\BIONTECH, 1017105,PA,71.0,M,"Had a near death one night; crawled from the bathroom to the couch, and his wife would help him walk; blacked out a couple times; Palpitation; Lower Legs started to get numb; Diarrhea; Nausea; Getting itchy, entire body; Weak/Weakness; This is a spontaneous report from a contactable physician (patient) A 71-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot: EL3248), via an unspecified route of administration in the left arm on 25Jan2021 at single dose for COVID-19 immunisation. Medical history included seasonal allergy. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (Batch/lot number: EK9231) on 04Jan2021 at single dose in left arm for COVID-19 immunisation and experienced non serious slightly sore arm lasted for 2 to 3 days. On 25Jan2021 the patient experienced blacked out a couple times (serious due to disability, life threatening), palpitation (serious as life threatening), lower legs started to get numb (medically significant) with outcome of recovered on 25Jan2021, diarrhea and nausea (both medically significant) with outcome of recovered on 26Jan2021; Getting itchy, entire body and weak/weakness (both medically significant) with outcome of recovering. The patient has also a near death one night with outcome of unknown. The patient reported that received the second was on 25Jan2021, and about 10 hours later, he started getting itchy, his entire body was itchy, this was all in about 20 minutes, he was weak, then he got diarrhea, nausea, he blacked out a couple times, he had the weakness, then he crawled from the bathroom to the couch, and was afraid and his wife would help him walk, as he didn't think he would make it, he was on the couch with palpitations and was itchy all over, and after an hour he fell asleep, and he came within seconds of going to the ER, the palpitations got worse, and he has no heart problems in the family, but it was a terrible reaction, he didn't think he would make it through the night, and he was not an allergic person, the only thing he was allergic to was seasonal, in the spring time. Also, his lower legs started to get numb in between all that. Started to get itchy 10 hours after the second shot. He was much better the following morning, he just has a little weakness from the havoc on the body. Numbness in lower legs lasted only about 10-15 minutes.; Sender's Comments: Based on a compatible temporal association, a causal relationship between reported events and BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021082193 Same Reporter/Patient, Different Dose of vaccine/Event",Not Reported,,Yes,Not Reported,,Yes,N,01/25/2021,01/25/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Seasonal allergy,,,"['Asthenia', 'Diarrhoea', 'Fear', 'Gait disturbance', 'Hypoaesthesia', 'Loss of consciousness', 'Nausea', 'Near death experience', 'Palpitations', 'Pruritus']",2,PFIZER\BIONTECH, 1017107,IN,,F,"anaphylactic shock; bleeding disorder (blood clots); atrial fibrillation; little sore arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient calling-in because she received her 1st shot of vaccine earlier today. She claims that it is too late when she reads the fact sheet. she called-in because she has bleeding disorder (blood clots) or atrial fibrillation and taking xarelto. She also reported that she had anaphylactic shock. Reporter stated she never experienced an anaphylactic reaction just a little sore arm, she just called to obtain information as she currently takes an anti-coagulant. Therapeutic measures were taken as a result of bleeding disorder (blood clots), atrial fibrillation. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1017108,TN,89.0,F,"Shortness of breath; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, Expire Date: Apr2021), via an unspecified route of administration on 15Jan2021 09:00 at single dose, right arm for covid-19 immunization. Indication reported as ""Hopes she wouldn't get COVID"", Stated that was why she got the Measles vaccination. The patient's medical history and concomitant medications reported as none. The patient previously got flu shot for immunization in Oct2020. The patient experienced shortness of breath on 17Jan2021. Caller told the woman administering it that she had been short of breath and was advised it was alright to receive the COVID-19 Vaccine. The patient had been really short of breath ever since. She wasn't very short of breath before the COVID-19 Vaccine. She was more so short of breath after the COVID-19 Vaccine. Shortness of Breath was noticed increase on 17Jan2021 at night. She was fine during the day, but could not lie down to go to sleep in bed. Sat up all night. Then it just came and went. Sometimes thought it was gone, but shortness of breath came back. The patient called doctor and was advised to go into an urgent care. She was going at time of the report. Relevant tests reported as none, regular check up at doctor. She wanted to know if she could get the second COVID-19 vaccine on 06Feb2021. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/17/2021,2.0,UNK,,,,,,"['Dyspnoea', 'Orthopnoea']",1,PFIZER\BIONTECH, 1017109,MA,47.0,F,"Visual problems, diplopia, concerns for left 4th cranial nerve paralysis",Not Reported,,Not Reported,Not Reported,,Yes,N,01/08/2021,01/24/2021,16.0,PVT,None,None,None,,None,"['Blood test', 'Diplopia', 'Visual impairment']",2,PFIZER\BIONTECH,IM 1017110,MD,35.0,M,"Severe elevation of blood pressure as high as 180/100; vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occurred/Blisters have opened leaving behind painful ulcers; vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occurred; vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occurred/Blisters have opened leaving behind painful ulcers; Painful ulcers; Painful ulcers; vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occurred/leaving behind painful ulcers; vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occurred/leaving behind painful ulcers; vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occurred/leaving behind painful ulcers; vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occurred/leaving behind painful ulcers; This is a spontaneous report from a contactable physician (patient/reported for himself). A 35-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via intramuscular on the left arm, on 21Jan2021 at 16:00 at single dose for covid-19 immunisation. The patient had no medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. The patient had no allergies to medications, food, or other products. No history of allergic reactions to any meds (medication) in the past or other vaccines in childhood. Otherwise young healthy male with no history of hypertension. The patient was not diagnosed with COVID-19 prior to vaccination. The patient concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Lot number: EJ1686) via intramuscular on the left arm on 30Dec2020 at 16:00 for COVID-19 immunization and experienced severe elevation of blood pressure. On 22Jan2021, at 12:00 AM, after the 2nd dose in left arm, after about 24 to 48 hours, the patient experienced vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occurred, peaking on day three and still remain after one week. The blisters have opened leaving behind painful ulcers. This is not a rash that disappears in a few days. It will take much longer than that to heal. No rash with the first dose. Also, with both doses, had severe elevation of blood pressure as high as 180/100 within 2 to 5 hours on 22Jan2021, requiring about 3 doses of clonidine over 7 days where bp would cycle up and down. The seriousness of the events was reported as non-serious. Since the vaccination, the patient has been not tested for COVID-19. Therapeutic measures were taken as a result of events and included Benadryl, mometasone cream and clonidine. The outcome of the events was reported as recovering. No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/22/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Blister rupture', 'Blood pressure fluctuation', 'Blood pressure increased', 'Rash', 'Rash erythematous', 'Rash pruritic', 'Rash vesicular', 'Skin ulcer', 'Ulcer']",2,PFIZER\BIONTECH,OT 1017111,WV,71.0,M,"sleeping 40 hrs; Severe diarrhea; vomiting; Unable to walk without help; This is a spontaneous report received from a contactable consumer (patient himself). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Unknown/ not available at the time of report completion), via an unspecified route of administration on right arm on 23Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included liver disease and ""chrons"". Patient had no allergies. Concomitant medication included paracetamol (TYLENOL). The patient experienced severe diarrhea, vomiting, unable to walk without help and sleeping 40 hrs on 28Jan2021 01:00. Patient. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The seriousness of the events was reported as non-serious. The patient did not receive any treatment for the events. The outcome of the events was reported as not recovered. No follow-up attempts are possible; Information about lot/ batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/28/2021,5.0,UNK,TYLENOL,,Medical History/Concurrent Conditions: Crohn's disease; Liver disorder,,,"['Diarrhoea', 'Gait disturbance', 'Gait inability', 'Hypersomnia', 'Vomiting']",UNK,PFIZER\BIONTECH, 1017113,LA,75.0,M,"Was not able to walk/He could not move his legs, but now he is able to stand; His knees were hurting; This is a spontaneous report from a contactable consumer. A 75-year-old male patient (reporter's brother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via intramuscular on 22Jan2021 at single dose for COVID-19 vaccination. Medical history included 2 heart attacks, stroke, she said that he had had numerous other things. His physician said that he was doing fine with all of the different things that he had. She said that he did not get enough oxygen when he was born and was a little slow because of that. There were no concomitant medications. The caller said that her brother today 25Jan2021 got up after doing a few little things and said that the paperwork talks about joint discomfort. He was not able to walk after a little while. This was something new. She said that his knees were hurting. She had to use a wheelchair to get him to the car. The cardiologist said that there was nothing wrong with his heart when and said that she made an appointment with his primary care doctor as well. She said that she made an appointment with his primary care for tomorrow evening 26Jan2021. Caller said that she was not saying that it was from the vaccine. She said that he could not move his legs, but now he was able to stand. At 15:00 central time 25Jan2021, he was able to stand up and walk to the chair. She said that it was an improvement. The caller said that her brother took the shot on Friday 22Jan2021. He got up did his regular routine and at about 11:50, he was in the den and was standing with a cane and was holding on to the cane and was not moving his legs. They got the wheelchair out of the car and sat him down. He said that his knees were hurting at that time. He was not able to move his feet at all. She said that he does not complain at all. Caller said that when this happened, her bother He was not slurring his words or having any other symptoms. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/25/2021,3.0,UNK,,,Medical History/Concurrent Conditions: Heart attack; Hypoxemia (he did not get enough oxygen when he was born and is a little slow because of that.); Stroke,,,"['Arthralgia', 'Gait inability', 'Mobility decreased', 'Musculoskeletal discomfort', 'Walking aid user', 'Wheelchair user']",UNK,PFIZER\BIONTECH,OT 1017114,NJ,,F,"localized injection site reaction: redness, swollen and warm to the touch; localized injection site reaction: redness, swollen and warm to the touch; localized injection site reaction: redness, swollen and warm to the touch; This is a spontaneous report from a contactable Nurse. This Nurse reported similar events for 3 patients. This is 2nd of 3 patients. A 82-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 21Jan2021 at SINGLE DOSE on right arm for covid-19 immunisation. Medical history and concomitant medications were none. The patient experienced localized injection site reaction: redness, swollen and warm to the touch on 24Jan2021 with outcome of not recovered considered as important medical event. Term highlighted by the reporter: Yes.Outcome of the events was not recovered. Caller works in an assisted living facility. Information on Lot/Batch has been requested.; Sender's Comments: Based on temporal association and currently known drug profile, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events 'localized injection site reaction: redness, swollen and warm to the touch'. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021093798 Same reporter/drug/AE, different patient;US-PFIZER INC-2021093835 Same reporter/drug, different patient/AE",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/24/2021,3.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Injection site erythema', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Skin reaction']",1,PFIZER\BIONTECH,OT 1017116,OR,44.0,F,"cellulitis from Right shoulder to Right elbow within 48 hours of shot, necessitating antibiotic therapy for cellulitis.; Fevers to 102 F; chills x 48 hours; severe Right arm swelling; This is a spontaneous report from a contactable physician (patient). A 44-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number 4121 EL 1283) , via an unspecified route of administration from 19Jan2021 13:15 at single dose on right arm for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced cellulitis from right shoulder to right elbow within 48 hours of shot, necessitating antibiotic therapy for cellulitis. The patient experienced fevers to 102 f, chills x 48 hours, severe right arm swelling on 20Jan2021 02:00. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 20Jan2021. Therapeutic measures taken as a result of the events included Keflex times 10 days. No covid prior vaccination, no covid tested post vaccination, no other vaccine in four weeks. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported events cellulitis, fever, chills and swelling arm. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/20/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Injection site cellulitis', 'Peripheral swelling', 'Pyrexia']",1,PFIZER\BIONTECH, 1017118,VA,,F,"Atrial fibrillation; palpitations; This is a spontaneous report from a contactable other health professional. This other health professional reported similar events for 2 patients. This is the 2nd of 2 reports. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced atrial fibrillation and palpitations on unspecified dates. Caller said that the patient had the atrial fibrillation about the same length of time she developed atrial fibrillation after her vaccine. The outcome of the events were unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event Atrial fibrillation cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021111497 same reporter and product, similar events with different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Atrial fibrillation', 'Palpitations']",UNK,PFIZER\BIONTECH, 1017120,FL,77.0,M,"Patient was put into Irregular Heart rhythm 3 hours post vaccine; This is a spontaneous report from a contactable other healthcare professional (HCP). A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el8982) Intramuscular on 29Jan2021 03:15 PM at single dose for covid-19 immunisation. Medical history included atrial fibrillation, prostate CA and dyslipidemia. No known allergies. No COVID prior vaccination. Concomitant medications were not reported. no other vaccine in four weeks. Patient was put into irregular heart rhythm 3 hours post vaccine on 29Jan2021 06: 15 PM, resulted in Life threatening illness (immediate risk of death from the event). Treatment included medication. No COVID tested post vaccination. Patient was recovered from the event on unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of arrhythmia due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient with medical history included atrial fibrillation and dyslipidemia. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Atrial fibrillation; Dyslipidemia; Prostate cancer,,,"['Apparent life threatening event', 'Arrhythmia', 'Heart rate irregular']",1,PFIZER\BIONTECH,OT 1017121,MA,74.0,F,"Diagnosed with sixth nerve palsy; Diarrhea; Headache; Nausea; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiry date: Mar2021), via an unspecified route of administration on 02Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included hypertension. Concomitant medication included cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), calcium (CALCIUM), rosuvastatin (ROSUVASTATIN). The patient experienced double vision and diagnosed with sixth nerve palsy on Jan2021, diarrhea and headache and nausea on 2021. The reporter stated ""I am calling in reference to reporting possible side effect or adverse reaction to the vaccine. It is in reference to my mother, she had the first dose on 02Jan2021 and 14 days later, she started with double vision, ended up in the hospital. She was in the hospital 4 days (4 nights), diagnosed with sixth nerve palsy."" The patient was hospitalization from 18Jan2021 to 22Jan2021. Reporter stated, ""She was in hospital, she has visiting nurse now for physical therapy that comes to house and they going to redraw her labs tomorrow Wednesday. They were basically normal, all the lab results were normal."" Therapeutic measures were taken as a result of double vision, diagnosed with sixth nerve palsy. Outcome of the events was unknown.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,01/02/2021,01/01/2021,,UNK,VITAMIN B12 [CYANOCOBALAMIN]; CALCIUM; ROSUVASTATIN,,Medical History/Concurrent Conditions: Hypertension,,,"['Diarrhoea', 'Diplopia', 'Headache', 'IVth nerve paralysis', 'Laboratory test normal', 'Nausea', 'VIth nerve paralysis']",1,PFIZER\BIONTECH, 1017123,CA,88.0,F,"I had a violent reaction; lesion on my brain and found everything once I was in hospital; I am upset; Dizziness; Vomiting; the ""rungs"" (not clarified) and the stomach after giving me something it stopped. I went from both ends when I had to throw up I just went out from both ends, (it was) bad; This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient received first dose of bnt162b2 (BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunization. Medical history included diabetes, blood pressure high, thyroid. Concomitant medication included amlodipine, valsartan (DIOVAN), metformin, levothyroxine sodium (LEVOXYL) for thyroid, atorvastatin (LIPITOR). The patient had the shot on Saturday and Sunday, she had a violent reaction and she just want to report it. It was first shot she had the first on Saturday and it happened (incomplete sentence). Her follow up was that she found other problems. She found lesion on her brain, she found everything else once she was in the hospital. So actually this reaction was (incomplete sentence). She known never she was little upset today. She was not right why not follow up latter she was little upset today, so she just want to let you know she had a problem. When probed for the vaccination date, consumer stated, the date was 23Jan2021. When probed for start date of the events, consumer stated, it was 24Jan. When probed for the side effects, consumer stated, she had extreme dizziness, she had extreme vomiting and ""run"" (not clarified) and that was about it Dizziness she went to 12 o'clock noon she started with the dizziness and it was over in about 5 in the afternoon and the ""rungs"" (not clarified) and the stomach after giving her something it stopped. She went from both ends when she had to throw up she just went out from both ends, (it was) bad. They did not give her anything for that. They did all sorts of test and found out that she had other problems. When probed for any Laboratory test, consumer stated, ""Yes, she did it and she was fine."" When probed for laboratory results, consumer stated, ""No, she did not have the results. Her doctor just gave them to her over the phone and said that she was good. Her A1C was 5.9."" The event lesion on her brain was reported as serious per hospitalization. The patient underwent lab tests and procedures which included glycosylated haemoglobin: 5.9 on an unspecified date. The outcome of events was unknown.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/23/2021,,,UNK,AMLODIPINE; DIOVAN; METFORMIN; LEVOXYL; LIPITOR [ATORVASTATIN],,Medical History/Concurrent Conditions: Blood pressure high (Verbatim: Blood pressure high); Diabetes (Verbatim: Diabetes); Thyroid disorder (Verbatim: Thyroid),,,"['Aphasia', 'Central nervous system lesion', 'Diarrhoea', 'Dizziness', 'Emotional distress', 'Glycosylated haemoglobin', 'Vomiting']",1,PFIZER\BIONTECH, 1017124,SC,,U,"I could feel flutters that I was having; he tells me that my heart has got out of rhythm when I took that shot; my blood pressure started coming down but my heart rate stayed not like that but somewhere 140-150 till 3rd morning; blood pressure and it was 204/108/The blood pressure is high and it still goes up to the 60s and 180 but I have no symptoms of whatsoever that anything is wrong; He said that was causing an allergic reaction and got my heart out of rhythm; I woke up and I was just really hot; My head was wringing wet; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiration date: May2021), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Consumer stated that the patient just wanted to let them know because they had told in patient's thread on the paper if you have any kind of allergic reaction to let them know. The patient went over to get the shot last Friday (22Jan2021) and about the time the patient got somewhere in the eastern area the patient could feel flutters that the patient was having so the patient came back home, the patient took his/her blood pressure and it was 204/108 and the patient heart rate was 140 something. So, the patient called the doctor and he told the patient to take a Benadryl, lay down for 2 hours. It did not go away. The patient needed to go to the ER. Well, the patient's blood pressure started coming down but the patient heart rate stayed not like that but somewhere 140-150 till 3rd morning (in Jan2021). The blood pressure was high and it still went up to the 60s and 180 but the patient had no symptoms of whatsoever that anything was wrong. Other than there in the night, that Friday night (22Jan2021), the patient woke up and the patient was just really hot. The patient's head was wringing wet. But he/she got no fever. The patient got up and she/he stood up 30 minutes and the patient took his/her blood pressure and the patient thought it was maybe 180 and the pulse was still high and now when the patient took it, it went like start out at 80 and goes around like 66. Consumer stated that the patient did not go because she/he had got an appointment with a doctor Thursday (Jan2021) and the patient did not go. The patient did not feel bad but he told the patient that his/her heart had got out of rhythm when the patient took that shot. He said that was causing an allergic reaction and got the patient heart out of rhythm. So, the patient was just concerned about the 2nd shot. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/22/2021,0.0,UNK,,,,,,"['Arrhythmia', 'Cardiac flutter', 'Feeling hot', 'Heart rate increased', 'Hyperhidrosis', 'Hypertension']",1,PFIZER\BIONTECH, 1017126,CA,65.0,F,"light headed, dizzy; blood pressure was taken and registered at 235/105; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 03Feb2021 12:00 at single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included allopurinol (ALLOPURINOL). No other vaccine in four weeks. The patient previously took morphine and experienced allergies. Immediately upon receiving the vaccine (03Feb2021 12:00), The patient became light headed, dizzy. Her blood pressure was taken and registered at 235/105 (on 03Feb2021), she was taken to the emergency room. She remained there for 2-3 hours then sent home. Events treatment: EKG. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 1 day, Life threatening illness (immediate risk of death from the event). The outcome of events was not recovered. The patient was not pregnant. No covid prior vaccination. No covid tested post vaccination. information on the lot/batch number has been requested.",Not Reported,,Yes,Yes,1.0,Not Reported,N,02/03/2021,02/03/2021,0.0,UNK,ALLOPURINOL,,,,,"['Dizziness', 'Electrocardiogram']",1,PFIZER\BIONTECH, 1017128,,,F,"Passed away; This is a spontaneous report from a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. This is a spontaneous report from a contactable consumer reporting for friend's mother. A 50-years-old female patient received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 vaccine on an unknown date. The patient passed away on an unspecified date. The patient was a healthy woman, who just got her 2nd dose of the vaccine a couple of days before. The patient died in her sleep. Doctor labeled her death as 'natural causes'. It was not reported if an autopsy was performed. No follow-up attempts are Possible. Information on lot/batch cannot be obtained.; Reported Cause(s) of Death: Passed away",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],2,PFIZER\BIONTECH, 1017129,NV,65.0,M,Sudden cardiac death. Autopsy report: right coronary artery thrombosis.,Yes,12/28/2020,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/28/2020,11.0,PVT,"Losartan, aspirin.",,Hypertension. Diet & exercise-controlled diabetes. History of DVT 4 yrs prior to event. After completing a course of Xarelto has been on aspirin ever since.,,None known,"['Autopsy', 'Coronary artery thrombosis', 'Sudden cardiac death']",1,PFIZER\BIONTECH,IM 1017156,MA,85.0,M,"Patient had R sided facial droop and slurring of speech at 9:30 AM 1/21/2021. Sent to Hospital where he was found to have CVA, with complete occlusion of the R vertebral artery from the origin of distal V3 segment.",Not Reported,,Not Reported,Yes,8.0,Yes,N,01/20/2021,01/21/2021,1.0,SEN,"Albuterol inhaler, salmeterol-fluticasone, Incruse Ellipta, loratadine, Lexapro, Xanax prn, guaifenesin, spironolactone, furosemide, carvedilol, folic acid, ferrous gluconate, multivitamin, pantoprazole, oxymetazoline spray prn, saline nas",,"chronic hypoxic respiratory failure due severe COPD, bronchiectasis, HFrEF, pulmonary HTN, essential HTN, hyperlipidemia, cardiomyopathy, major depression, generalized anxiety disorder, anemia, GERD, recurrent epistaxis, dementia",,"ceftriaxone, lisinopril","['Angiogram cerebral', 'Blood test', 'Cerebrovascular accident', 'Computerised tomogram head', 'Dysarthria', 'Facial paralysis', 'Vertebral artery occlusion', 'X-ray']",2,PFIZER\BIONTECH,IM 1017167,,69.0,M,Respiratory distress sent to the ER and admitted on 2/3 with respiratory failure,Not Reported,,Not Reported,Yes,5.0,Not Reported,N,02/01/2021,02/03/2021,2.0,SEN,,,"PNEUMONIA, UNSPECIFIED ORGANISM, CALCULUS OF KIDNEY WITH CALCULUS OF URETER, ORTHOSTATIC HYPOTENSION, OTHER IRON DEFICIENCY, ANEMIAS, CEREBRAL PALSY, EPILEPSY, UNSPECIFIED, NOT INTRACTABLE, WITHOUT STATUS EPILEPTICUS, MIXED HYPERLIPIDEMIA, MUSCLE WEAKNESS (GENERALIZED) R27.9 UNSPECIFIED LACK OF COORDINATION R13.12 DYSPHAGIA, OROPHARYNGEAL PHASE",,ASA,"['Respiratory distress', 'Respiratory failure']",UNK,PFIZER\BIONTECH, 1017171,NY,70.0,M,"Patient felt fine until time of first vaccine on 1/4/2021 after which he developed fatigue and fever and then developed a cough. Started cefpodoxime x 3 days, further work up included chest xray with no findings on 1/11/21 and a chest CT on 1/13/21 with large lower lobe consolidation. He was directly admitted on 1/13/21 for pulmonary abscess. On admission he had leukocytosis and fever of 103. Workup did not identify an infectious cause but raised concerns for an auto immune cause such as Wegener Granulomatosis. Remained febrile for about 14 days",Not Reported,,Not Reported,Yes,21.0,Not Reported,U,01/04/2021,01/13/2021,9.0,PVT,None,None,Questionable history of tuberculosis/ Covid pneumonia March 2020,,NKA,"['Antineutrophil cytoplasmic antibody increased', 'Antineutrophil cytoplasmic antibody positive', 'Blood immunoglobulin E increased', 'Blood immunoglobulin G increased', 'Computerised tomogram thorax abnormal', 'Cough', 'Culture negative', 'Fatigue', 'Granulomatosis with polyangiitis', 'Leukocytosis', 'Lung abscess', 'Lung consolidation', 'Pathology test', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1017176,MO,76.0,M,"Patient had Covid-19 in October of 2020. He recovered. He received the vaccination on 12/30/2020 with no complaints. On 01-05-2021 it was noted to he was incontinent of urine and bilateral lower extremity edema. Lab work was completed showed acute kidney injury. He had decreased blood pressure and oxygen saturations on 01-06-2021 He was admitted to the hospital with rapid progression of symptoms and suggested multi-system failure. He had a long cardiac history. On 01-14-2021 he passed away with a diagnosis of Cardiomyopathic CHF, A.Fib contributory.",Yes,01/14/2021,Not Reported,Yes,9.0,Not Reported,N,12/30/2020,01/05/2021,6.0,OTH,"Apixaban, Aspirin, Atorvastatin, Budesonide, Carvedilol, Docusate, Ferrous Gluconate, Furosemide, Lisinopril, Omperazole, Tiotropium Bromide inhaler, Amlodipine, Tylenol, Albuterol, Naproxen","Hypertension, Chronic ischemic heart disease, COPD, Atrial Fibrillation, Cardiomyopathy, Edema, Dementia, Anemia, Hyperlipidemia","COPD, Chronic ischemic heart disease, A fib, Hypertension",,"NKA, NKDA","['Acute kidney injury', 'Atrial fibrillation', 'Blood pressure decreased', 'Cardiac failure congestive', 'Cardiomyopathy', 'Death', 'Laboratory test abnormal', 'Multiple organ dysfunction syndrome', 'Oedema peripheral', 'Oxygen saturation decreased', 'Urinary incontinence']",1,MODERNA,IM 1017205,MD,35.0,M,"Rash, difficulty breathing, cotton mouth, tight chest, hives, swelling tongue,",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PVT,None,None,None,,None,"['Chest discomfort', 'Dry mouth', 'Dyspnoea', 'Rash', 'Swollen tongue', 'Urticaria']",1,MODERNA,SYR 1017212,,78.0,M,The patient suffered a cardiac arrest and remains in the hospital at this time.,Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/06/2021,02/07/2021,1.0,SEN,,,CHF Diabetes,,"Erythromycin, Nabumetone, Zocor, Sulfa drugs",['Cardiac arrest'],2,PFIZER\BIONTECH,SC 1017219,MI,76.0,M,Found unresponsive on the floor 19 hours after receiving the vaccine. Transported to hospital.,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/08/2021,02/09/2021,1.0,OTH,"Colazal, zyrtec, cymbalta, lasix, neurontin, cozaar, toprol-xl, remeron, Singulair, morphine, flomax, lipitor, lantus, novolog",none,"Diabetes, hypertension, asthma","circa 1976, approximately 32 yo, Swine Flu shot left sided numbness for 1 year.",Sulfa,"['Blood glucose', 'Chest X-ray', 'Computerised tomogram', 'Magnetic resonance imaging', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 1017226,MA,77.0,F,Flash pulmonary edema,Not Reported,,Not Reported,Yes,,Not Reported,Y,02/07/2021,02/08/2021,1.0,PVT,"ALPRAZolam (XANAX) 0.25 MG tablet Sig: TAKE 1 TABLET BY MOUTH TWICE DAILY AS NEEDED Patient not taking: Reported on 2/9/2021 CALCIUM CARBONATE/VITAMIN D3 (CALCIUM 500 + D, D3, ORAL) Sig: Dose: 1 TAB; Form: Not available; Route: PO; Frequenc",Progressive dyspnea.,"HTN, HFpEF, CKD III, IDA",,NKA,"['Acute pulmonary oedema', 'Brain natriuretic peptide increased']",UNK,PFIZER\BIONTECH, 1017232,AK,30.0,F,"Approximately 12 days after vaccination co began to have fatigue, weakness, Pancytopenia Recent hospitalization which involved initial presentation at hospital on AK 12/29, and then again on 12/30, after eval on 12/30 was then transferred to another hospital, and later transferred where she later recovered and was discharged. She was initially very ill and was thought to have sepsis due to fever/initial presentation/clinical picture, also had lab abnormalities including thrombocytopenia. These things necessitated transfer. While at hospital, hematology was consulted. Decision was made to transfer due to concern for DIC/possibility of leukemia. Also there was concern for C Diff, treatment was given for this. While in hospital, she underwent further testing on blood samples which revealed no evidence for malignancy, also bone marrow biopsy was performed. While there, DIC labs were trended/began to improve. Discharged on 1/5/21. Had f/u with hematology @ hospital on 1/12/21. No reason has been found as of yet as to why she became ill. Per discharge note it's thought it could have been viral in nature, or possibly related to supplement use. Will f/u with heme in early Feb. Of note, she does report getting her first dose of pfizer covid vaccine on 12/17/20, she reports concern that this could have played a part in her illness. She states this was the only new/out of the ordinary thing that she can remember recently, regarding her medical hx, prior to recent acute illness/hospitalization. Requests I reach out to inquire how she can file a report with Pfizer or CDC",Not Reported,,Yes,Yes,7.0,Not Reported,Y,12/17/2020,12/29/2020,12.0,PVT,,none,C diff PCOS,,NKDA,"['Asthenia', 'Biopsy bone marrow', 'Blood test normal', 'Fatigue', 'Illness', 'Laboratory test abnormal', 'Pancytopenia', 'Thrombocytopenia']",1,PFIZER\BIONTECH,IM 1017267,SD,87.0,M,"Patient awoke at 0600am with chest pain. He took two nitro and tried to go back to sleep. At 0800am he awoke again with the chest pain and took 2 nitro which again helped the pain. At that time he did experience shortness of breath and diaphoresis. He was found to have decreased O2 sats when the EMTs got to him and he was placed on a non-rebreather. On x-ray the patient was found to have a right pneumothorax, cardiac markers were negative. A chest tube was placed and the patient was transferred to a hospital.",Not Reported,,Yes,Yes,,Not Reported,N,02/08/2021,02/09/2021,1.0,PVT,"Amlodipine, Enteric Coated Aspirin, Atorvastatin, Gabapentin, Lactobacillus Acidophillus, Lorazepam, Multivitamin, Nitroglycerin, Potassium Chloride, Primidone, Tamsulosin, Ubidecarenone, Preservision, Vitamin A, Vitamin D, Vitamin B",Evaluated for tremors in January,"Hypertension, Coronary artery disease, valvular heart disease, peripheral neuropathy, gastroesophageal reflux disease, hypercholsterolemia",,Aspirin,"['Chest X-ray abnormal', 'Chest pain', 'Chest tube insertion', 'Coronavirus test negative', 'Dyspnoea', 'Hyperhidrosis', 'Myocardial necrosis marker normal', 'Oxygen saturation decreased', 'Pneumothorax']",1,MODERNA,IM 1017272,CA,82.0,M,Myocardial infarction Pancytopenia,Not Reported,,Yes,Yes,5.0,Not Reported,N,01/21/2021,01/22/2021,1.0,OTH,"Was taking lisinopril asa,","Htn, hyperlipidemia , mi stent , brain aneurysm",As above,,Nkda,"['Blood test abnormal', 'Myocardial infarction', 'Pancytopenia', 'Platelet count decreased', 'Troponin increased']",1,PFIZER\BIONTECH,IM 1017300,OH,84.0,F,"EMG: Demyelinating neuropathy, possible AIDP vs developing CIDP",Not Reported,,Not Reported,Yes,14.0,Not Reported,U,01/19/2021,01/26/2021,7.0,WRK,Cefdinir 300mg po BID (5 day Rx) Diphenhydramine 25mg -50mg po QAM Levothyroxine 125mcg po AM Adult MVI with FA Gummy po AM Nifedipine (Adalat CC) 24-hr tab 60mg po AM,"hypertension, hypothyroidism, asthma, dementia, bladder repair surgery, macular degeneration, left eye blood clot hx, UTI, anemia","hypertension, hypothyroidism, asthma, dementia, b macular degeneration",,"Hives from: Meloxicam (and SOB); Sulfamethoxazole-trimethoprim; tolterodine LA (and itching); Nitrofurantoin; Oxybutynin; Potassium Iodide; Simvastatin; Sulfasalazine; Ezetimibe Itching from: rosuvastatin; butalbital-aspirin-caffeine Unknown rxn to: bisacodyl, butalbital-aspirin-caffeine; ceftriaxone; propoxyphene N-acetaminophen; oxybutynin; hydromorphone; iodine; omega-3 FA (Lovaza); Niacin; phenazopyridine; Sulfa (sulfonamide antibiotics); nitrofurantoin monohy/m-cryatal (Macrobid) Cramps in hands and stiffness of entire body: fenofibrate Pain, muscle pain, severe leg cramps: atorvastatin GI intolerance: cefdinir","['Albumin CSF increased', 'Blood albumin decreased', 'Blood albumin increased', 'Blood immunoglobulin A normal', 'Blood immunoglobulin G normal', 'CSF immunoglobulin increased', 'CSF neutrophil count increased', 'CSF protein increased', 'CSF red blood cell count positive', 'CSF test abnormal', 'Demyelinating polyneuropathy', 'Electromyogram abnormal', 'Vitamin B12 increased']",1,PFIZER\BIONTECH,IM 1017313,AZ,93.0,F,"acute respiratory failure, atrial fibrillation",Not Reported,,Yes,Yes,4.0,Not Reported,U,01/30/2021,02/01/2021,2.0,PVT,Carvedilol Lisinopril,none,high blood pressure,,none,"['Acute respiratory failure', 'Atrial fibrillation']",UNK,PFIZER\BIONTECH, 1017339,FL,88.0,M,"Admitted to hospital with sob upon exertion that started prior to vaccine. Hx COPD, HTN, CKD, hyperlipidemia, bladder cancer in remission. Stated he has been taking Eliquis and Xarelto between renal doctor and cardiologist Dr. Anticipating going home 2/5/21 but then turned blue and stopped breathing under a DNR. COVID test negative. Labs show acute on chronic renal failure with an elevated troponin likely from demand ischemia.",Yes,02/05/2021,Not Reported,Yes,4.0,Not Reported,N,01/30/2021,02/05/2021,6.0,PHM,"Furosemide Lasix, 20 mg PO daily at 0600 Simvastatin 20 mg Tablet PO daily Amlodipine Norvasc 2.5 mg Tablet PO daily Tamsulosin HCl 0.4 mg Capsle PO daily Dutasteride 0.5 mg Capsule PO daily Metroprolol Tartrate Lopressor 25 mg Tablet PO on","sob with exertion, started just prior to vaccine",A-fib Bladder cancer history CKD COPD HTN,,Penicillin hives Sulfonamide Antibiotics hives,"['Acute kidney injury', 'Cyanosis', 'Dyspnoea exertional', 'Laboratory test abnormal', 'Respiratory arrest', 'SARS-CoV-2 test negative', 'Troponin increased']",1,MODERNA,IM 1017351,LA,56.0,M,"Temp. Imbalance Chills, Nausea , fatigue, foul diarrhea (like when I had COVID in July) low grade elevated temp.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,02/08/2021,18.0,OTH,"SOTALOL,LIPITOR,XARELTO, DILTIAZEM Emergen-C",Atrial flutter/fibrillation S/p cardiac ablation 12/07/2020,Atrial flutter/fibrillation,,NKDA,"['Chills', 'Diarrhoea', 'Fatigue', 'Nausea', 'Pyrexia']",2,MODERNA,IM 1017355,MS,81.0,M,Right side vocal cord paralysis,Not Reported,,Not Reported,Not Reported,,Yes,N,01/13/2021,01/18/2021,5.0,PVT,"Clonidine,allopurinol,hczc water pill,amlodipine,potassium simvastatin,80mg aspirin, lumigan eye drops",None,"Heart disease, glaucoma, gout",,Altace,"['Laryngoscopy', 'Vocal cord paralysis']",1,MODERNA, 1017358,TX,79.0,M,"2-3-2021 pt reported to ER c/o dyspnea, A-fib HR 91, SARSCoV2 RNA test positive in ER, dyspnea on exertion occasional cough, pt admitted to medical surgical floor with acute systolic CHF and COVID-19 with bronchitis, pt was discharged to a nursing home for rehab",Not Reported,,Not Reported,Yes,3.0,Not Reported,,01/29/2021,02/03/2021,5.0,PVT,"atorvastatin calcium po 20mg qd, spironolactone 25mg po qd, coumadin 4mg po qd, torsemide 20mg po 2tablets qd, losartan potassium 50mg po qd, duo neb bid",,"A-fib, CHF, lung disease, heart disease, HTN",,NKDA,"['Acute left ventricular failure', 'Atrial fibrillation', 'Blood glucose increased', 'Brain natriuretic peptide increased', 'Bronchitis', 'COVID-19', 'Carbon dioxide increased', 'Cardiac failure congestive', 'Chest X-ray abnormal', 'Condition aggravated', 'Cough', 'Dyspnoea exertional', 'Haematocrit normal', 'Haemoglobin decreased', 'Lung infiltration', 'Platelet count decreased', 'SARS-CoV-2 test positive', 'Troponin normal']",1,MODERNA,IM 1017367,IA,99.0,F,"Individual collapsed 9 days post-vaccination with no known reason. Despite being healthy prior to vaccination, individual's condition deteriorated rapidly. Individual passed away on 1-17-2021.",Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/14/2021,9.0,SEN,,Individual was healthy prior to vaccination.,Individual had Alzheimer's disease.,,,"['Death', 'General physical health deterioration', 'Syncope']",UNK,PFIZER\BIONTECH, 1017380,,68.0,F,"pt contracted COVID -19 post vaccine dose #1. the vaccine was given on January 12, 2021 and she was diagnosed via laboratory testing on January 22 and informed January 23 of a positive test result. She was admitted to the hospital on February 1 due to SOB caused by COVID 19 per the clinician's note. She had a 4 day hospital stay and was discharged on February 4, 2021.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,01/12/2021,01/23/2021,11.0,PUB,,,,,,"['COVID-19', 'Dyspnoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1017381,CA,88.0,F,Resident passed away 2 days after receiving the vaccine. oxygen level has decreased shortly 1 day after receiving the vaccine.,Yes,02/08/2021,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/08/2021,2.0,SEN,,,,,,"['Death', 'Oxygen saturation decreased']",UNK,PFIZER\BIONTECH, 1017393,CA,73.0,F,Patient received the vaccine on 1/26/2021 and per employee at facility patient passed away on 2/01/2021.,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,01/26/2021,02/01/2021,6.0,SEN,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1017411,TX,82.0,F,patient developed blood clot in her left groin one week after getting first COVID19 vaccine.,Not Reported,,Yes,Yes,2.0,Not Reported,N,01/27/2021,02/03/2021,7.0,PVT,"mirtazapine 30mg, valsartan 320mg, boniva 150mg, amlodipine 5mg, cyclobenzaprine 10mg, pravastatain 10mg, memantine 5mg, tramadol 50mg, ambien 5mg",none,"type 2 diabetes, lumbago, depression, and insomnia",,amoxicillin,['Thrombosis'],UNK,PFIZER\BIONTECH, 1017412,OH,55.0,F,"Patient is a 55 y.o. female presenting from home with complaint of shortness of breath. Patient tested positive for COVID-19 infection in January 15. Last 2 days started to get sob with mild cough, no phlegm production Denies chest pain Initially had fever, but no fever last 3 days In ED, dropped sat to 89% momentarily, but was found to be tachycardic 130 range sinus CT PE was negative for PE, showed Mild infiltrative changes of the left lower lobe and lingula. �Likely related to patient's known atypical infectious process. �No superimposed dense airspace consolidation Pt has been treated with Remdesivir, Decadron and supportive care. Pt has been stable in room air. Pt wants to go home today. She will receive the fourth dose of Remdesivir. Then she is OK to be discharged home. She will follow up with primary care physician Pt reported dysuria. Her UA showed positive nitrite. One dose of Cipro 500 mg given (pt is allergy to Amoxicillin). She will continue take Cipro 500 mg twice a day for 7 days for UTI.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/06/2021,01/22/2021,16.0,PVT,"topiramate, tizanidine, naproxen, magnesium oxide, Vitamin D3, eletriptan prn",none,migraine HA,,amoxicillin,"['Adrenal adenoma', 'COVID-19', 'Computerised tomogram thorax abnormal', 'Cough', 'Dyspnoea', 'Dysuria', 'Hepatic steatosis', 'Lung infiltration', 'Nitrite urine present', 'Oxygen saturation decreased', 'Pyrexia', 'SARS-CoV-2 test positive', 'Tachycardia', 'Urinary tract infection', 'Urine analysis']",1,MODERNA,IM 1017425,TX,37.0,F,"Patient reports that 20 minutes after receiving vaccination that she developed throat tightness and swelling and associated trouble swallowing and shortness of breath. She was treated with IM Epinephrine and IV Benadryl on site and EMS transported to Emergency Department. EMS reported symptoms returned en route and 2nd dose of IM epinephrine given. In the ED, pt received a 3rd dose IM epinephrine when her symptoms worsened again, and was admitted to the hospital for monitoring overnight. She was discharged home today.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,02/08/2021,02/08/2021,0.0,OTH,,,,,,"['Dysphagia', 'Dyspnoea', 'Pharyngeal swelling', 'Throat tightness']",1,PFIZER\BIONTECH,IM 1017445,IL,89.0,F,"Patient is a 89 y.o. female with a history of a TAVR that presented to the emergency room few hours after having a 40 min episode of chest pain. The patient states she was just eating and suddenly started having sharp pain on the left side of her chest. There was a little bit of associated shortness of breath, but not much. She states it was sharp in nature and seem to stay about the same for about 40 min. She states that she does seem to get chest pain sometimes when she vacuums, but usually if she sits down it immediately goes away. She reports that she saw PAC about a week ago and was thought to be a little bit fluid overloaded. She was started on a little bit of oral Lasix and was supposed to come see provider later in the week. She states she has diuresed very aggressively the last few days and is feeling quite a bit less short of breath. In the ER, her EKG did not show anything acute. Troponin was normal. BNP was mildly elevated, but her imaging did not show any signs of acute congestive heart failure. Her D-dimer was elevated. However, she was not having any pain while she was in the emergency room. Her pulse was normal and her oxygen saturations were in the high 90s.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/29/2021,02/03/2021,5.0,PVT,amlodipine aspirin chlorthalidone nitroglycerin potassium chloride,,,,nka,"['Blood creatine phosphokinase', 'Blood creatine phosphokinase MB', 'Blood magnesium', 'Brain natriuretic peptide increased', 'Chest pain', 'Computerised tomogram thorax', 'Dyspnoea', 'Electrocardiogram normal', 'Fibrin D dimer increased', 'Fluid overload', 'Metabolic function test', 'Platelet count decreased', 'Polyuria', 'Troponin I', 'Troponin normal']",1,MODERNA,IM 1017454,VA,73.0,F,"Two days after receiving the vaccine, on Jan 28th, I noticed pain in my right lower back area. It went away so I didn?t pay much attention to it. On Jan 29th, I woke up to stabbing pains in my right chest which continued to night of Jan 30th. Morning of Jan 31st, I was very short of breath and could hardly get around. I went to the ER in evening of Jan 31st. I was admitted due to two pulmonary embolisms in my lungs. Doctors were convinced I had Covid 19. However, three tests came up negative. I was put on a Heparin drip and then eventually on Eliquis. I have always been healthy up to this point and never had any clotting issues. I now am on Eliquis for at least six months (have to have a follow-on echocardiogram due to issues on right side of my heart.). I am convinced the vaccine triggered the clots.",Not Reported,,Yes,Yes,3.0,Not Reported,N,01/26/2021,01/28/2021,2.0,OTH,Esomeprazole Singulair Vitamin D Zinc Vitamin B12,,,,,"['Anticoagulant therapy', 'Back pain', 'Cardiac disorder', 'Chest X-ray', 'Chest pain', 'Coagulation factor V level', 'Computerised tomogram thorax', 'Dyspnoea', 'Echocardiogram abnormal', 'Gene mutation identification test', 'Mobility decreased', 'Pulmonary embolism', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 1017470,OH,87.0,M,My dad had the covid vaccine on Thursday & Friday morning we couldn't wake him up. He had a significant change in mental status. An ambulance needed to be called & he was hospitalized for a week. He is currently in a rehabilitation hospital.,Not Reported,,Not Reported,Yes,7.0,Not Reported,U,01/28/2021,01/29/2021,1.0,OTH,Tafamidis 61mg Monday & Friday Potassium Chloride 10meq bid Simvastatin 20mg daily Omeprazole 20mg daily Toresemide 20mg 4 tabs daily Ferrous Sulfate 325mg daily INSPRA 50mg daily Eliquis 2.5 mg bid Metoprolol 25mg 1/2 tab daily Metformin,none,CHF Diabetes HTN High cholesterol,,nka,"['Loss of consciousness', 'Mental status changes', 'Unresponsive to stimuli']",1,MODERNA,IM 1017509,NH,80.0,F,"Day after receiving the vaccine, the patient complained of abdominal pain which worsened over the day. She went to the ED and was hospitalized. Abdominal pain complaints increased and continued, she decompensated rapidly, was intubated and subsequently died 3 days later. Imaging results showed, progressive ovarian cancer in the bowels. Blood culture revealed that she had E.Coli in her blood. It is thought that this is NOT related to the vaccine.",Yes,02/07/2021,Not Reported,Yes,3.0,Not Reported,N,02/04/2021,02/06/2021,2.0,PVT,"Amlodipine vitamin c calcium vitamin D cetirizine questran vit b12 estradiol gabapentin MOM Magnesium oxide potassium chloride Avastin, Carboplatin, Gemcitabine",Advanced Ovarian Cancer,spinal stenosis,,penicillins,"['Abdominal pain', 'Blood culture positive', 'Death', 'Endotracheal intubation', 'Escherichia bacteraemia', 'Magnetic resonance imaging abnormal', 'Ovarian cancer']",1,PFIZER\BIONTECH,IM 1017510,PA,47.0,F,per employee vomiting times 4 days then a 4 day hospital stay now with dizziness,Not Reported,,Not Reported,Yes,4.0,Not Reported,,01/13/2021,01/13/2021,0.0,PVT,,,,,,"['Dizziness', 'Vomiting']",UNK,MODERNA,IM 1017549,TX,71.0,F,Dr. received an urgent request to call a local Justice of the peace regarding one of her patients who was found dead in her home today. At this time no foul play is suspected. Dr. said the patient was relatively healthy with no major issues other than some hypertension,Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,,02/04/2021,02/09/2021,5.0,PVT,Medications amlodipine atorvastatin budesonide cephalexin ciclopirox desloratadine epinephrine flaxseed oil fluticasone propionate glucosamine HCl hydrocodone-acetaminophen ipratropium bromide Keflex lisinopril-hydrochlorothiazide olopatadi,,Problem List: abscess of sublingual space abscess of submandibular region chronic ethmoidal sinusitis chronic maxillary sinusitis disorder of salivary gland essential hypertension history of asthma hyperglycemia hyperlipidemia leukocytosis localized enlarged lymph nodes mass of hand seasonal allergic rhinitis,,"Penicillins, Levofloxacin, sulfa","['Death', 'Hypertension']",1,PFIZER\BIONTECH,IM 1017556,IL,84.0,M,"Patient has been weak and having difficulty urinating for the few days. Was unable to urinate this morning and made an appointment. On the drive to the appointment, he felt the urge to urinate and urinated in a urinal he had with him. The urine looked like blood with clots. Patient admits that he has had some clots in his urine for past week, so he had taken plavix to break up the clots (plavix is not his medication). Given weakness, difficulty urinating, and gross hematuria, patient was sent to the ER. ER nurse was called and given report",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/21/2021,01/28/2021,7.0,PVT,albuterol losartan,,,,crestor latex propofol,"['Activated partial thromboplastin time', 'Asthenia', 'Computerised tomogram abdomen', 'Differential white blood cell count', 'Dysuria', 'Full blood count', 'Haematuria', 'Haemorrhage urinary tract', 'Metabolic function test', 'Prothrombin time', 'Urinary retention', 'Urine analysis']",1,MODERNA,IM 1017563,KY,92.0,M,Patient got the injection and quickly developed a fever and felt weak. Family was contacted and he was sent to Hospital.,Yes,01/30/2021,Not Reported,Yes,12.0,Not Reported,N,01/09/2021,01/09/2021,0.0,SEN,"gabbapentin, morphine","arthritis, heart issues",neuropathy pain,,none that we know of,"['Asthenia', 'Death', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 1017596,,51.0,F,"1/12/21: Pt presented to ED with L sided facial droop, L sided weakness to arm and leg, numbness to L face L arm and left leg. Presentation consistent with acute ischemic stroke. Risks and benefits discussed with the patient, who agreed to proceed with tPA. MRI brain 1/12: ""Acute infarct right MCA territory predominantly involving the right parietal/insular lobes. No acute hemorrhage or midline shift."" Started on aspirin 325 mg daily and rosuvastatin dose increased to 40 mg daily 24 hours post tPA. Patient reported a history of a-flutter many years ago for which she was on a beta-blocker, but the diagnosis remains unconfirmed. Tele reviewed during stay, no arrhythmias. ECHO, normal EF, NO PFO. Discharged to rehab on 1/15.",Not Reported,,Not Reported,Yes,3.0,Not Reported,,01/04/2021,01/12/2021,8.0,PVT,,,,,,"['Cerebral infarction', 'Echocardiogram normal', 'Ejection fraction normal', 'Facial paralysis', 'Hemiparesis', 'Hypoaesthesia', 'Ischaemic stroke', 'Magnetic resonance imaging brain abnormal']",UNK,PFIZER\BIONTECH,IM 1017602,MD,54.0,F,"On Tuesday went to work and at around 1:30 she told her boss that she was not feeling good. Felt achy in her body, her arm was hurting and was not feeling like herself. She went home, sat on the sofa and drank something and went to sleep and felt drained, and slept for 4 hours. She then woke up with runny nose, low grade temp, and felt really weak. The next day, 1/6/21 her body ached bad. She slept a lot that day and drank a lot of water, didn't eat and just felt really sick. Then on Saturday evening, she looked at her leg and felt cold chills and her leg was hot. She looked at her leg and had an area that was like a red dot, and she then realized that her leg was about to be inflamed. She went to bed, woke up and her entire leg was blotchy red, swollen and hot. She then called her family and around 12:00 on Monday 1/11/21. She went to the hospital, and they treated her like she had COVID, isolated her and was negative. Sent her to vascular and did not have a blood clot in her leg, and told her she had an cellulitis flair, and she started being treated with IV antibiotics. Was in the hospital for 5 days. She was discharged and went home after infectious disease team told her to go home with a nurse on IV antibiotics. She came home on 1/15/21, and was off the IV antibiotics on 1/22/21. She has been home and unable to work. She is going to therapy for her legs. They changed her hypertension medications, and put back on her antibiotics last week as they told her that the swelling was not going down. Her kidney function is low and told today, 2/9/21 that she is concerned about her kidney function. She is to have more labs drawn on Monday, 2/15/21.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,"Amlodicpine, Singulair.",None.,"High blood pressure, asthma.",,Penicillin.,"['Asthenia', 'Cellulitis', 'Chills', 'Decreased appetite', 'Erythema', 'Fatigue', 'Feeling abnormal', 'Impaired work ability', 'Inflammation', 'Laboratory test', 'Malaise', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Rash macular', 'Renal function test abnormal', 'Rhinorrhoea', 'SARS-CoV-2 test negative', 'Skin warm']",1,MODERNA,IM 1017624,,72.0,M,"bilateral numbness, tingling Narrative: Pt had received Moderna Lot 029L20A on 1/28/21. Pt endorses that he began to feel tingling in his hands, bilaterally on 2/2/2021. Pt presented to hospital on 2/4/2021 w/ CC that his arms and legs were weak and he has been having difficulties going up stairs and getting out of bed and these symptoms are not normal for patient. Pt also noticed double vision in horizontal plane lasting up to 30min and resolves spontaneously and then returns a few hours later. Pt is currently being worked up to rule out GBS",Not Reported,,Not Reported,Yes,,Not Reported,U,01/28/2021,02/02/2021,5.0,OTH,,,,,,"['Diplopia', 'Hypoaesthesia', 'Mobility decreased', 'Muscular weakness', 'Paraesthesia']",1,MODERNA,IM 1017642,TX,19.0,F,"TTP flare, child with history of acquired TTP that had been on remission and off treatment for 5 years",Not Reported,,Yes,Yes,,Not Reported,,01/29/2021,02/07/2021,9.0,PVT,,,,,,"['Condition aggravated', 'Thrombotic thrombocytopenic purpura']",1,PFIZER\BIONTECH,SYR 1017675,MA,96.0,F,"This 96 year old resident was diagnosed with COVID on 10/28/2020. She has a significant, complicated medical history and did not return to her pre-infection level of health. She began declining in early January and was made care and comfort measures only on 1/2/2021. Most of her medications were d/c'd except for those that provided comfort. No obvious reaction to the vaccine was seen and we do not suspect that her death was vaccine related, however we were directed by Dept of Epidemiology to report her death as it was within one week of receiving the vaccine.",Yes,01/10/2021,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/10/2021,7.0,SEN,"capsacin pad, Ativan liquidMorphine Sulfate 20mg/ml","COPD, Diabetes Mellitus type 2","Nalignant neoplasm of cecum, COVID positive 10/2020, cerebral infarction,athersclerotic heart disease, heart failure, AV block",,sulfa antibiotics,"['Death', 'General physical health deterioration']",UNK,PFIZER\BIONTECH,IM 1017680,NY,32.0,F,"The same day as the shot I had an extreme headache and arm was sore. Approx a week and a half later I noticed broken blood vessels over my body, went to my PCP had a blood draw and was informed I had a platelet count of 1. I was sent to the ER then to hematology. I received an very large infusion and was put on 40 mg of Dexamethasone for 4 days. The next step is to get more blood work and see if I need another infusion. After the infusion I was really sick and passing out .",Not Reported,,Yes,Yes,1.0,Not Reported,N,01/15/2021,01/24/2021,9.0,PUB,Phentaramine 30 mg once daily,None,Thalassemia Minor,,PCN Sulfa Drugs,"['Blood test', 'Haemorrhage subepidermal', 'Headache', 'Loss of consciousness', 'Malaise', 'Pain in extremity', 'Platelet count decreased']",1,MODERNA,IM 1017681,CT,94.0,F,"94 yo F presented from assist living with slur speech for 1 day, last seen well on 1/30. Pt has a PMH of dementia (Baseline, she will keep saying, ""help me, help me"", AOX3, using walker, could go to bathroom by herself), hx breast cancer (s/p lumpectomy, chemo, Tamoxifen, currently not on tx), HTN, HLD, vaginal bleeding (no further work up by family), overactive bladder (on solifenacin), hx of MI (undocumented, no PCI or CABG), spine stimulator placed. According to patient's daughter, she saw her January 30, she was doing okay after the vaccine. On 1/31 when the daughter called her on the phone, she knows she has some slurred speech, when she saw patient in the facility, she noticed her gait becomes unsteady. She decided to bring her to the hospital. 1/30, she noticed the patient has spilled up some water, otherwise denies fever, chills, shortness of breath, pain, chronically, she has constipations taking laxative. In the ED, pt was afebrile, 36.1, heart rate 85, blood pressure 130/61, respiratory rate 18, saturations 98 on room air. Labs shows, sodium 134, potassium 3.6, bicarb 28, BUN 18, creatinine 0.97, glucose 119, WBC 12.5, hemoglobin 11.8, platelet 239. PT INR 1.09, COVID negative. CT head suggestive of subacute infarct. Possible including small vessel ischemic changes. Chest xray questionable patchy left retrocardiac atelectasis or pneumonia. EKG shows atrial fibrillation's heart rate 71, QTc 610. Case was discussed with neurology in the ED, patient was not a TPA or embolectomy candidate. CT head suggestive of acute/subacute cerebellar infarct. Patient does not have any residual or sensory deficit except expressive aphasia. Neuro saw patient, mentioned patient appears to have had a stroke that by the CAT scan criteria is already subacute. The patient was admitted on the stroke pathway. The patient has new onset atrial fibrillation and therefore should be considered for anticoagulation. The patient cannot have an MRI of the brain due to her spinal cord stimulator but given that the stroke is already subacute on the CT without any signs of hemorrhagic conversion she could be started on this at this point. If she gets started on anticoagulation the aspirin should be stopped. If the patient cannot go on anticoagulation or does not want to then she might be a candidate for dual antiplatelet therapy for secondary stroke prevention. 2D echo shows normal ejection fraction of the left ventricle estimated at 70 to 75%. Regional wall motion abnormality was not observed. Right ventricle systolic function is normal. Moderate aortic stenosis. Cardio was consulted for anticoagulation, From cardioembolic prevention standpoint, anticoagulation is recommended to prevent CVA. However, she has significant risks for bleeding given recent vaginal bleeding (investigation not pursued to spare her comfort), age, comorbidities, etc. Again, further discussion between family and primary team is required regarding risks vs benefits. Was evaluated by speech-language pathology present minimal oral dysphagia no overt clinical signs of aspiration, recommended to continue with NDD 2 diet/thin liquid. Patient was discharged to ECF.",Not Reported,,Not Reported,Yes,4.0,Not Reported,,01/29/2021,01/31/2021,2.0,SEN,"docusate sodium 10 mg/mL oral liquid, 100 mg= 10 mL, Oral, every day at bedtime felodipine 10 mg oral tablet, extended release, 10 mg= 1 tab, Oral, Daily indapamide 2.5 mg oral tablet, 2.5 mg= 1 tab, Oral, every morning Mapap 325 mg oral","PMH of dementia (Baseline, she will keep saying, ""help me, help me"", AOX3, using walker, could go to bathroom by herself), hx breast cancer (s/p lumpectomy, chemo, Tamoxifen, currently not on tx), HTN, HLD, vaginal bleeding (no further work up by family), overactive bladder (on solifenacin), hx of MI (undocumented, no PCI or CABG), spine stimulator placed.","PMH of dementia (Baseline, she will keep saying, ""help me, help me"", AOX3, using walker, could go to bathroom by herself), hx breast cancer (s/p lumpectomy, chemo, Tamoxifen, currently not on tx), HTN, HLD, vaginal bleeding (no further work up by family), overactive bladder (on solifenacin), hx of MI (undocumented, no PCI or CABG), spine stimulator placed.",,None,"['Atelectasis', 'Atrial fibrillation', 'Blood bicarbonate normal', 'Blood creatinine normal', 'Blood glucose increased', 'Blood potassium normal', 'Blood sodium decreased', 'Blood urea normal', 'Cerebellar infarction', 'Cerebral infarction', 'Cerebrovascular accident', 'Chest X-ray abnormal', 'Computerised tomogram head abnormal', 'Condition aggravated', 'Drooling', 'Dysarthria', 'Echocardiogram normal', 'Electrocardiogram', 'Gait disturbance', 'Haemoglobin decreased', 'International normalised ratio decreased', 'Platelet count normal', 'SARS-CoV-2 test negative', 'White blood cell count increased']",2,PFIZER\BIONTECH, 1017693,,64.0,F,"Narrative: Patient admitted to the hospital 2/7/21 following episode of nausea/vomiting, elevated blood pressure, bradycardia, elevated lactate, fever, and leukocytosis. Patient treated with intravenous fluids and started on intravenous antibiotics. CT of the abdomen on 2/8/21 identifies mild acute diverticulitis.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/28/2021,02/07/2021,10.0,OTH,,,,,,"['Blood lactic acid increased', 'Blood pressure increased', 'Bradycardia', 'Computerised tomogram abdomen abnormal', 'Diverticulitis', 'Leukocytosis', 'Nausea', 'Pyrexia', 'Vomiting']",2,MODERNA,IM 1017724,MI,75.0,F,Acute pericarditis complicated by atrial flutter,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/15/2021,01/16/2021,1.0,UNK,"cholecalciferol, diclofenac gel, MVI, omeprazole, rosuvastatin, Tylenol PRN",,"Osteoarthritis, gastric sleeve 2011, GERD, HLD",,None,"['Atrial flutter', 'Brain natriuretic peptide increased', 'C-reactive protein increased', 'Computerised tomogram aorta', 'Echocardiogram', 'Ejection fraction normal', 'Pericardial effusion', 'Pericarditis', 'Red blood cell sedimentation rate increased']",UNK,PFIZER\BIONTECH, 1017734,,47.0,F,the patient tested positive for COVID 19 after receiving dose #1 of the COVID 19 Pfizer vaccine.,Not Reported,,Not Reported,Yes,5.0,Not Reported,U,01/13/2021,01/18/2021,5.0,PUB,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1017744,CA,85.0,F,Unknown,Yes,01/28/2021,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/27/2021,1.0,OTH,Unknown,Unknown,Unknown,,Unknown,['Unevaluable event'],1,PFIZER\BIONTECH,IM 1017765,AZ,71.0,F,"I work at medical center where patient is being treated for a new diagnosis of Acute monocytic leukemia. I was able to that the patient was vaccinated with Moderna vaccine on 1/16/2021, patient does not have the vaccination card with the Lot number so this is unknown at this time. Here are the details I see in the chart. Patient arrived on 1/30/2021 at 2100, per History and physican patient has not been feeling well for about a week and a half, and had received the moderna vaccine approximately 2 weeks prior to this time. Doctors note states about a week after first COVID vaccine she noted chest and back pain, dyspnea, high grade fevers and for this went to the ER on 1/28/21 and found to have anemia Hemoglobin 10 with normal LFTs. She was thought to have a reaction to vaccination and sent home. When her symptoms did not get better she went to ER again on 1/30 and found to have Hemoglobin down to 8 and marked LFTs elevation. Pathology evaluated elevated WBC and showed monocytosis and possible blast cells and patient transferred for further workup. per oncologist patient went to primary care about 6 months ago and had a normal CBC. Patient was started on chemotherapy for diagnosis of AML during this admission, as of 2/9/2021 patient remains inpatient, is intubated in ICU with prognosis unknown at this time.",Not Reported,,Yes,Yes,,Not Reported,N,01/16/2021,01/20/2021,4.0,UNK,bupropion 300 mg daily and simvastatin 20 mg daily,felt healthy and hiking 3-4 miles per day previous to vaccination,"depression, CKD stage III, hyperlipidemia, hypothyroidism, migraine, history of cervical cancer (only treatment was hysterectomy no chemotherapy or radiation)",,no known allergies,"['Acute monocytic leukaemia', 'Acute myeloid leukaemia', 'Alanine aminotransferase normal', 'Anaemia', 'Anaemia macrocytic', 'Aspartate aminotransferase normal', 'Back pain', 'Band neutrophil percentage', 'Biopsy bone marrow abnormal', 'Blood bilirubin normal', 'Blood creatinine normal', 'Blood culture negative', 'Chemotherapy', 'Chest X-ray', 'Chest pain', 'Computerised tomogram thorax', 'Computerised tomogram thorax abnormal', 'Dyspnoea', 'Endotracheal intubation', 'Eosinophil percentage', 'Fibrin D dimer increased', 'Haematocrit decreased', 'Haemoglobin decreased', 'Intensive care', 'International normalised ratio increased', 'Liver function test increased', 'Lymphocyte percentage', 'Malaise', 'Monocyte percentage', 'Monocytosis', 'Neutrophil count decreased', 'Neutrophil percentage decreased', 'Platelet count decreased', 'Prothrombin time prolonged', 'Pyrexia', 'Red blood cell count decreased', 'SARS-CoV-2 antibody test positive', 'SARS-CoV-2 test negative', 'Thrombocytopenia', 'Troponin normal', 'White blood cell count increased', 'White blood cell count normal']",1,MODERNA, 1017789,IL,66.0,F,"Patient is a 66 y.o. female presents with increasing shortness of breath and fatigue the last few days. The patient presented to the ER just a few days after being discharged from Hospital. The patient was treated as an inpatient at Hospital little under a week ago for a COPD exacerbation. She showed dramatic improvement during this time, but over the last few days has started showing increasing signs of shortness of breath and severe fatigue. She has no known coronavirus (COVID-19) contact, but states that anything is possible. Her rapid coronavirus (COVID-19) test in the ER was negative. However, her chest CT seem to suggest a severe viral pneumonia. Because of this, the patient is going to be admitted to the hospital as she has failed outpatient therapy and is significantly hypoxic.",Not Reported,,Not Reported,Yes,6.0,Not Reported,U,01/27/2021,01/28/2021,1.0,PVT,,,,,Gabapentin Latex Nsaids Topamax Valium,"['Blood creatine phosphokinase', 'Blood creatine phosphokinase MB', 'Blood culture', 'Blood lactic acid', 'Blood magnesium', 'Brain natriuretic peptide', 'Chest X-ray', 'Chronic obstructive pulmonary disease', 'Computerised tomogram thorax abnormal', 'Differential white blood cell count', 'Dyspnoea', 'Electrocardiogram', 'Fatigue', 'Fibrin D dimer', 'Full blood count', 'Hypoxia', 'Metabolic function test', 'Platelet count', 'Pneumonia viral', 'Prothrombin time', 'SARS-CoV-2 test negative', 'Scan with contrast', 'Troponin', 'Urine analysis']",1,MODERNA,IM 1017828,CA,65.0,F,"Second COVID vaccine on 1/14/21 - The patient is received her second dose of Pfizer vaccine at Hospital. Post dose she experienced intermittent sensation of tingling on left posterior neck area with no paresthesia and difficulty lifting bilateral extremities. Three days after administration of the vaccine she began noticing weakness in her legs that eventually progressed to her arms bilaterally. She developed pitting edema and SOB. Per infectious disease MD, the main suspicion is for GBS Guillain-Barre Syndrome given exam findings. Pt's weakness and resulting inability to ambulate may have pushed pt into CHF exacerbation. Patient received 3 days of IVIG which was discontinued due to worsening mental status. Naranjo scale score of 2 indicates possible ADR.",Not Reported,,Not Reported,Yes,,Yes,N,01/14/2021,01/17/2021,3.0,PUB,None,Morbid obesity,None,,meperidine,"['Dyspnoea', 'Gait inability', 'Guillain-Barre syndrome', 'Immunoglobulin therapy', 'Mental status changes', 'Mobility decreased', 'Muscular weakness', 'Oedema', 'Paraesthesia']",2,PFIZER\BIONTECH, 1017838,TX,59.0,M,"Around 1:00 pm started coughing blood,hour later had fever 104 had to be rushed to ER. I was hospitalized for 8 days. The physician diagnosed me with bacterial pneumonia. After being discharged from hospital had another CT scan found 3 in undefinable mass on right lung and nodules left lung. I have a appt scheduled to follow up with a Pulmonary specialist on 3/9.",Not Reported,,Not Reported,Yes,8.0,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,No,No,No,,No,"['Blood test', 'Computerised tomogram abnormal', 'Haemoptysis', 'Pneumonia bacterial', 'Pulmonary mass', 'Pyrexia', 'X-ray']",1,PFIZER\BIONTECH,IM 1017843,WI,58.0,M,"Pt arrives to ED via EMS with c/o blood in the urine, pain, and weakness since this morning. Pt states the staff noticed the blood this morning in his urine; pt denies any pain while urinating. Pt is incontinent per his normal. Pt states he received is first covid vaccination about 4 days ago, and yesterday he received his biyearly MS treatment. Pt states that one doctor told him to wait a month in between the vaccine and treatment, another said 2 weeks, and one said he could get it right away. Pt states that this morning, his MS flared up worse than its ever been. Pt states he is having severe muscle spasms and pain in the bilateral shoulders and right leg. Pt states that he has also been weaker",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/26/2021,01/30/2021,4.0,UNK,"acetaminophen (TYLENOL) 325 MG tablet Take 650 mg by mouth every 6 hours as needed. ReasonsFever, Pain NOTE: Maximum recommended dose of acetaminophen from all sources is 4 g per day. aspirin (ECOTRIN) 81 MG enteric coated tablet Take 81 m",No,"MS, TBI, TIA, Seizure, PE, DVT, BPH, HLD, depression, chronic pain, arthritis",,No known allergies,"['Arthralgia', 'Asthenia', 'Blood urine present', 'Condition aggravated', 'Haematuria', 'Incontinence', 'Multiple sclerosis relapse', 'Muscle spasms', 'Pain', 'Pain in extremity']",1,MODERNA, 1017893,IL,43.0,M,My brother has epilepsy. His seizures can be triggered by low grade fever and exhaustion. He had covid in early October. His seizures are generally well controlled but he had several after the vaccine. I understand that the vaccine did not cause the seizures. The fever caused the seizure. I just think it?s important to neurologists to have this info to see how we can go about mitigating the seizures and if the 2nd dose is necessary. Keeping him hydrated may have helped and also giving him something immediately for the low grade fever. Just knowing these things may help others.,Not Reported,,Yes,Yes,4.0,Not Reported,Y,01/29/2021,01/30/2021,1.0,UNK,"Depakote, keppra, primidone, acetazolamide, minocycline, anti depressant, respridol",None,Epilepsy that caused developmental disabilities,,"Zyprexa, doxicycline","['Blood culture negative', 'Condition aggravated', 'Culture urine negative', 'Electroencephalogram normal', 'Pyrexia', 'Seizure']",1,MODERNA, 1017937,OR,69.0,F,"Fever, confusion, sepsis, hospitalized",Not Reported,,Not Reported,Yes,,Not Reported,N,01/31/2021,02/08/2021,8.0,UNK,,,,,,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood lactic acid', 'Confusional state', 'International normalised ratio increased', 'Lymphocyte count increased', 'Platelet count decreased', 'Procalcitonin decreased', 'Procalcitonin increased', 'Pyrexia', 'Sepsis', 'White blood cell count decreased']",1,MODERNA,IM 1017947,,23.0,M,"Chest pain, started the same day as the vaccine. Seen in ER 4 days later since symptoms had not alleviated.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/03/2021,02/03/2021,0.0,MIL,,,,,,"['Chest pain', 'Electrocardiogram normal', 'Troponin increased']",2,MODERNA,IM 1017960,MO,89.0,F,Pt was deceased when we came for second dose. COD unknown to pharmacy.,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,U,01/06/2021,02/03/2021,28.0,PHM,,,,,,['Death'],2,MODERNA,IM 1017971,MO,100.0,F,Pt was deceased when we came for second dose. COD unknown to pharmacy,Yes,02/02/2021,Not Reported,Not Reported,,Not Reported,,01/06/2021,02/02/2021,27.0,PHM,,,,,,['Death'],2,MODERNA,IM 1017974,MO,87.0,F,Pt was deceased when we came for second dose. COD unknown to pharmacy,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,,01/06/2021,02/01/2021,26.0,PHM,,,,,,['Death'],2,MODERNA,IM 1017978,MO,79.0,F,Pt was deceased when we came for second dose. COD unknown to pharmacy,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,,01/06/2021,02/01/2021,26.0,PHM,,,,,,['Death'],2,MODERNA,IM 1018082,TX,34.0,M,"I had COVID-19 and tested positive on December 23rd, 2020. I had a loss of taste and smell. It was not a complete loss. More like an 80% loss. I received my first COVID vaccine dose on 01/08/2021. By about mid January, however, I had almost all, if not all, of my taste/smell back. But after my second Moderna COVID-19 Vaccine dose, I lost my sense of taste and smell again. When I was at about 90-100% recovered, as of the 2 or 3 days following my 2md vaccine dose, I had lost almost all taste and smell again. As of today, 4 days after the vaccine, I'm back to around 80% again. I have not had any other congestion, etc. that might explain my loss of taste and smell.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/05/2021,02/06/2021,1.0,PVT,None.,None,None,,None,"['Ageusia', 'Anosmia', 'Condition aggravated']",2,MODERNA,IM 1018097,TX,80.0,F,"Three days after first dose, I awoke in the early morning hours to go to bathroom. I lost all strength in my body and fell injuring my rib, arms, head and shoulder I have been hospitialized for two days now.",Not Reported,,Yes,Yes,5.0,Not Reported,N,02/04/2021,02/08/2021,4.0,PVT,motoprelol; warfarin,"heart arythmia; excessive fluid buildup, blood pressure elevated",none,,none known,"['Asthenia', 'Chest injury', 'Computerised tomogram head', 'Computerised tomogram thorax', 'Echocardiogram', 'Electrocardiogram', 'Electroencephalogram', 'Fall', 'Head injury', 'Limb injury']",1,MODERNA, 1018126,FL,72.0,M,"Patient received vaccination on 2/4. Patient's wife reported that he felt a slight soreness in his arm the day following the shot, but had no other symptoms. On 2/8 he passed away. Wife reports that it was related to his heart and they never made it to a hospital. The wife also reported that the patient had been in poor health prior to the vaccination",Yes,02/08/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/08/2021,4.0,PHM,,chronic conditions listed below,"per wife-diabetes, hypertension, hypercholesterolemia, depression, cvd, previous stroke",,na,"['Death', 'Pain in extremity']",1,MODERNA,IM 1018146,PA,90.0,M,"Four days later, my father had a severe brain aneurysm.",Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/01/2021,4.0,PVT,"Levothyroxine, carpidopa-levodopa, colchicine, januvia, sertraline HCL, finasteride, valsartan, febuxostat, daily vitamin centrum, vitamin d",None,"Type 2 diabetes, BPH, gout, high blood pressure",,None,['Intracranial aneurysm'],1,MODERNA,SYR 1018226,PA,82.0,M,"Given vaccine in AM, had adverse reaction around 1430 when he was found unresponsive and in respiratory distress",Not Reported,,Yes,Yes,1.0,Not Reported,U,02/09/2021,02/09/2021,0.0,SEN,None that I am aware of. Would need to discuss further with staff,None that I am aware of. Would need to discuss further with staff.,"COPD, history of covid in November 2020, diastolic heart failure, neurogenic bladder with foley catheter in place, dementia",,None that I am aware of. Would need to discuss further with staff.,"['Blood bicarbonate normal', 'Blood lactic acid', 'Blood lactic acid increased', 'Blood pH decreased', 'Leukocytosis', 'PCO2 increased', 'Respiratory distress', 'Unresponsive to stimuli', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 1018228,CA,74.0,F,"At 3pm resident was taken by EMS to local hospital. She had complained of respiratory distress (hx of COPD). Property manager reported that paramedic said she was ""in cardiac arrest"". We do not have more information at this time.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/09/2021,02/09/2021,0.0,PUB,Blood thinners - others unknown,"COPD, Heart condition, ? weaken immune system Felt dizzy over the weekend (2-3 days prior to vaccine)","COPD, Heart",,,"['Cardiac arrest', 'Respiratory distress']",1,MODERNA,IM 1018229,TN,31.0,F,"Approximately 15 minutes after patient received Pfizer vaccine #1 she began to experience shortness of breath, tachypnea, tachycardia, diaphoresis, and hives to upper extremities.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/04/2021,02/04/2021,0.0,PUB,Unknown,none,unknown,,"Vistaril, IV dye","['Dyspnoea', 'Hyperhidrosis', 'Tachycardia', 'Tachypnoea', 'Urticaria']",1,PFIZER\BIONTECH,IM 1018257,CA,80.0,F,"severe body aches starting evening of vaccine (dose #1), along with worsening weakness. Vaccine given 1/26/2021. Pt with ED visit for body aches 2/8/21 (high ESR > 100). Then admitted for observation 2/9/21",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/26/2021,01/26/2021,0.0,SEN,"gabapentin, pradaxa, atorvastatin, advair, duloxetine, metoprolol, singulair, albuterol, norco, pepcid, lasix",was getting over covid pneumonia early January,"htn, asthma/copd, CAD, lumbar spinal stenosis/chronic LBP, OSA, AFib, CHF, osteoporosis, diffuse osteoarthritis multiple joints",,"amlodipine (edema), lisinopril (cough)","['Asthenia', 'Blood creatine phosphokinase normal', 'Loss of personal independence in daily activities', 'Pain', 'Red blood cell sedimentation rate increased']",UNK,PFIZER\BIONTECH, 1018278,WI,74.0,F,death- unexplained cause,Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/09/2021,13.0,PVT,"Lisinopril, Flonase, famotidine",,"Hypertension, breast cancer",,none,['Death'],UNK,PFIZER\BIONTECH, 1018448,HI,90.0,M,2/6/2021 stroke. 2/8/2021 he died,Yes,02/08/2021,Not Reported,Yes,2.0,Not Reported,N,02/01/2021,02/06/2021,5.0,OTH,"aspirin 81 mg qd. vitamin D. duloxetine, cymbalta 20 mg qd. Jalyn one daily. ferrous sulfate. namenda. spiriva inhaler. zinc 50 mg qd",none,dementia. hx stroke. carotid disease. emphysema. hyperlipidemia. BPH,,oxycodone. penicillin. simvastatin,"['Cerebrovascular accident', 'Condition aggravated', 'Death']",1,MODERNA,IM 1018529,NJ,83.0,F,"Two nights later woke up not feeling well, trouble breathing. Increased oxygen next day. Returned oxygen level to normal following day and oxygen appeared okay. The next day, so five days after vaccine, had trouble breathing again and high blood pressure. Admitted to hospital and diagnosed with pneumonia. Currently hospitalized.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/04/2021,02/04/2021,0.0,SEN,"Metformin HCL 500mg Levothryoxine 75 mcg; oglyza 5mg; , Atorvatastin 10mg; Metopropol Succ ER 50mg ; Anoro Ellipta 62.5025mcg INhaler",none,"lung cancer five years earlier in remission, COPD, diabetes, high blood pressure, high cholesterol, prior mini stroke",,,"['Chest X-ray abnormal', 'Condition aggravated', 'Dyspnoea', 'Hypertension', 'Malaise', 'Pneumonia']",2,PFIZER\BIONTECH,SYR 1018647,CA,25.0,F,"I am a third-year medical student. Since receiving the second dose of the COVID vaccine (Pfizer) on Tuesday 2/2, I have had persistent and worsening muscle spasms of the torso. I presented to the Emergency room on 2/6 due to worsening symptoms and was admitted until 2/7. The neurology team evaluated my condition was not able to make a firm diagnosis. They believe the vaccine has caused a dystonic reaction. I was given benadryl 25mg to continue for one week q6 hours prn. However, benadryl has provided minimal relief. They also strongly recommended that I be seen by a movement disorder specialist at hospital ASAP. However, due to the fact that I have insurance I am not covered for care from hospital. My insurance said they will review the referral which will take another 5-7 business days from today 2/9. As a medical student, I have had to miss one week of clinic rotations and will continue to miss vital medical training as well as my board exam this Friday due to my worsening symptoms. It has created such a negative impact on my life including pausing my medical training, and physically being incapable of driving or performing many of my basic daily activities. I live alone and near hospital. I am urgently requesting if there is anyway CDC can help me, a medical student who has put in her all to fight the pandemic alongside you. I am extremely concerned about my symptoms and the panic that it has created for my family and friends. I hope that a rapid response can help me and my loved ones find some answers during these challenging times.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/02/2021,02/03/2021,1.0,PVT,Loryna oral contraceptive pill melatonin prn,none,none,,NKDA,"['Blood copper normal', 'Blood glucose normal', 'Ceruloplasmin normal', 'Condition aggravated', 'Dystonia', 'Full blood count normal', 'Impaired driving ability', 'Impaired work ability', 'Loss of personal independence in daily activities', 'Metabolic function test', 'Metabolic function test normal', 'Muscle spasms']",2,PFIZER\BIONTECH,IM 1020029,,71.0,M,"altered mental status and vomiting after receiving Pfizer vaccine Narrative: This is a 70 y/o male with past medical history significant for end stage renal disease on dialysis, diabetes, diabetic foot ulcer, ischemic cardiomyopathy, hypertension, status post left below knee amputation and severe peripheral vascular disease. He received Pfizer covid-19 vaccine on 1/11/21. Patient's sister reported that on 1/12/21 patient complained he ""couldn't think straight; his mind was not there"" after receiving the vaccine. Sister also noted patient had vomiting and then became progressively weak. On 1/18/21 (1 week later), the patient was brought to the Medical Center emergency room as patient had ""fever, diarrhea as well as cough"". The patient has h/o covid-19 positive on 7/28/20 but most recent covid-19 test was negative on 1/18/21. On 1/20/21 blood culture showed Staphylococcus aureus (2/2 sets). MRI of the brain on 2/3/21 showed ""small focus of acute ischemia in the left occipital lobe"".",Not Reported,,Not Reported,Yes,,Not Reported,N,01/11/2021,01/12/2021,1.0,OTH,,,,,,"['Asthenia', 'Cerebral ischaemia', 'Cough', 'Diarrhoea', 'Magnetic resonance imaging brain abnormal', 'Mental impairment', 'Pyrexia', 'SARS-CoV-2 test negative', 'Staphylococcus test positive', 'Vomiting']",1,PFIZER\BIONTECH,IM 1020038,,74.0,M,"DYSPNEA WITH HYPOXIA, WEAKNESS, LOSS OF APPETITIE, FATIGUE Narrative: Per nephr note 1/25/21: ""got 1st covid vaccine on 1/21/21 and 'was doing okay afterwards until over the weekend. He's fallen 3 times, has run a low grade fever and his oxygen sat is down to 88%.' Brought to ED, per ED MD note 1/25/21: after 1st covid vaccine dose, 'has had generalized weakness of all extremities w/ falls w/o injury; previously ambulated w/ walker but now unable to do so & using wheelchair; since vaccine has had decreased appetite and PO intake, fatigue, constipation (last BM on day of vaccine/4 days earlier), persistent SOB."" Admitted to hospital.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/21/2021,01/25/2021,4.0,OTH,,,,,,"['Activated partial thromboplastin time shortened', 'Asthenia', 'Brain natriuretic peptide increased', 'Chest X-ray abnormal', 'Constipation', 'Decreased appetite', 'Dyspnoea', 'Fall', 'Fatigue', 'Hypoxia', 'International normalised ratio', 'Oxygen saturation decreased', 'Pleural effusion', 'Prothrombin time prolonged', 'Pyrexia', 'Troponin I increased', 'Wheelchair user']",1,PFIZER\BIONTECH,IM 1018328,FL,,F,"Headache; Collapsed on the floor; Left arm injection site red; Rash; A spontaneous report was received from a consumer, who was also a 80-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced syncope, injection site redness, rash, and headache. The patient's medical history, as provided by the reporter, included high blood pressure. Concomitant product use reported included atenolol and atorvastatin. On 11 Jan 2021, one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly in the left arm for the prophylaxis of COVID-19 infection. On 12 Jan 2021, the patient noticed her left arm was getting redder and redder at the injection site. When she turned to look at the clock, the patient collapsed on the floor. She went to the medical center and was prescribed prednisone and diphenhydramine. On 21 Jan 2021, the patient reported she now had a headache that began on an unspecified date, and that her injection site redness and rash were still present, but getting better. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, syncope, was unknown. The events, injection site redness and rash, were considered resolving. The event, headache, was considered not resolved.; Reporter's Comments: This spontaneous report concerns an 80-year-old, female patient with medical history of high blood pressure who experienced serious event of syncope and non-serious events of injection site redness, rash and headache. The events of syncope rash and injection site redness occurred 1 day after administration of mRNA-1273 (Batch number: 039K20A, expiration date-unknown). On an unspecified date on the event of headache began. Treatment provided for the events included prednisone and diphenhydramine and the outcome is not resolved. injection site redness, rash and headache are consistent with the known safety profile of the mRNA-1273 Vaccine and hence, based on the temporal association between the events and the vaccine administration, a causal association cannot be excluded",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/12/2021,1.0,UNK,ATENOLOL; ATORVASTATIN,Blood pressure high,,,,"['Headache', 'Injection site erythema', 'Injection site rash', 'Syncope']",1,MODERNA,OT 1018424,,,M,"tested positive for covid 3-4 days afterward; tested positive for covid 3-4 days afterward; This is a spontaneous report from a contactable consumer. This male consumer of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The consumer received first dose 20 days before in Jan2021 and tested positive for COVID 3-4 days afterward in Jan2021. He was tested himself after 15 days and it said he had zero antibodies in Jan2021. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 antibody test negative', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018487,FL,69.0,F,"Pain through back across both arms and neck.; A headache that feels like my heads going to explode.; swell up like a balloon; Nauseated; Chills; fever; Pain on both my legs cannot walk; Pain through back across both arms and neck. Cannot lift my arms; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the right arm on 20Jan2021 16:00 at single dose for covid-19 immunization. Medical history included atrial fibrillation from an unknown date and unknown if ongoing , hypersensitivity (Known allergies: Yes) from an unknown date and unknown if ongoing, covid-19 (if covid prior vaccination: Yes) from an unknown date and unknown if ongoing. Concomitant medications included unspecified medications. The patient experienced pain through back across both arms and neck, the patient cannot lift their arms. The patient also experienced pain on both their legs cannot walk, a headache that feels like their heads going to explode, nauseated all the time, swell up like a balloon, chills and fever. It was reported that the events occurred on 21Jan2021. Therapeutic measures were taken as a result of pain through back across both arms and neck. The patient did not recover from the events. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/21/2021,1.0,UNK,,,Medical History/Concurrent Conditions: AFib; Allergy (Known allergies: Yes); COVID-19 (if covid prior vaccination: Yes),,,"['Back pain', 'Chills', 'Gait disturbance', 'Headache', 'Joint range of motion decreased', 'Mobility decreased', 'Nausea', 'Neck pain', 'Pain in extremity', 'Pyrexia', 'Swelling']",1,PFIZER\BIONTECH, 1018497,SC,42.0,F,"Acquired covid 19, exposed 18Jan2021. Symptoms began 22Jan2021. Positive PCR through DHEC; Acquired covid 19, exposed 18Jan2021. Symptoms began 22Jan2021. Positive PCR through DHEC; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), via an unspecified route of administration on 05Jan2021 at 09:15 am in the Left arm at single dose for COVID-19 immunization in hospital. Medical history was not reported. Prior to vaccination, it was unknown if patient was diagnosed with COVID-19. The patient's concomitant medications included fludrocortisone acetate, loratadine, escitalopram oxalate (LEXAPRO). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient acquired COVID 19 on 22Jan2021, exposed 18Jan2021. Symptoms began 22Jan2021. Positive PCR through DHEC. Since the vaccination, patient had been tested for COVID-19 PCR on 22Jan2021: Nasal Swab, result was Positive. No treatment was received for the events. The outcome of the events was not recovered.; Sender's Comments: The positive COVID-19 test occurred 17 days after the injection of suspect vaccine BNT162B2. The lack of efficacy of suspect BNT162B2 to the COVID-19 infection cannot be totally excluded. While the steroid fludrocortisone acetate and the target disease may predispose the patient to the virus infection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/22/2021,17.0,PVT,FLUDROCORTISONE ACETATE; LORATADINE; LEXAPRO,,,,,"['COVID-19', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018571,CA,50.0,M,"severe allergic reaction; This is a spontaneous report from a contactable physician. A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 21Jan2021at a single dose as Covid vaccine. Medical history included BPH, Meniere's disease, and known allergies to sesame oil. The patient had unspecified concomitant medications (other medications in two weeks). He had no other vaccine in four weeks. The patient experienced severe allergic reaction on an unspecified date in which resulted to emergency room/department or urgent care. Unspecified medications was provided as treatment for the event. He had no Covid prior to vaccination. He has not had Covid tested post vaccination. The outcome of the event was recovered on an unspecified date. No follow-up attempts are possible. Information about lot/batch number cannot obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of severe allergic reaction. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,,,UNK,,,Medical History/Concurrent Conditions: BPH; Meniere's disease; Oil allergy (known allergies to sesame oil),,,['Hypersensitivity'],1,PFIZER\BIONTECH,OT 1018574,,,U,"I received my first Pfizer covid vaccine in Dec and 3 days later was diagnosed with covid; I received my first Pfizer covid vaccine in Dec and 3 days later was diagnosed with covid; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2) at single dose in Dec2020 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the 1st dose vaccine in Dec2020 and 3 days later was diagnosed with Covid on an unknown date. The patient underwent lab tests and procedures which included Sars-cov-2 test: diagnosed with cCvid in Dec2020. Patient received the monoclonal antibody infusion and has recovered. Patient knew he/she needed to wait 90 days from the MCA infusion before having the second vaccination. Patient queried whether it would be recommended to start the series over with two additional vaccines since the timing between the first and second vaccines will be so long. Information on the lot/batch number has been requested.; Sender's Comments: The COVID-19 infection occurred 3 days after the injection of suspect vaccine BNT162B2. No complete effect can be achieved against the target disease due to the short time interval. The COVID-19 is more likely pre-existing condition, unrelated to suspect vaccine BNT162b2.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/01/2020,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018588,AR,57.0,M,"COVID-19 virus test positive; COVID-19 virus test positive; Blood pressure fluctuation; This is a spontaneous report from a contactable consumer reporting for himself and from another consumer. A 57-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK4176), via an unspecified route of administration in the right arm, on 05Jan2021 at 14:10, at single dose, for COVID-19 immunisation. Medical history included ongoing gout and ongoing blood pressure high. Concomitant medications included allopurinol (unknown manufacturer) from 2008 to an unknown date and from an unknown date to ongoing for gout, lisinopril (unknown manufacturer) from an unspecified date and ongoing for blood pressure high at 40 mg daily, an unspecified drug for blood pressure high from Dec2020 at 5 mg and an unspecified anti-inflammatory. The patient previously took allopurinol from 2008 for gout and experienced abdominal pain upper so the drug was stopped on unknown date but his uric acid levels get high and he had to go back on it again. The patient experienced COVID-19 virus test positive (medically significant) on 16Jan2021 with outcome of unknown and blood pressure fluctuation in Jan2021 with outcome of unknown. It was reported that the only symptom he had on 13Jan2021 at first was a crash in his blood pressure. It was in the 80's over 50's. After that he had a fever of 102.2 F on 13Jan2021 for which he took two Tylenol. On 13Jan2021 at 09:30 PM his temperature was back down to 98.8 F. He has not had anymore fever. He has not had any other symptoms since. His blood pressure fluctuated but they have made some changes with his medication. The patient underwent lab tests and procedures which included blood pressure: in the 80's over 50's on 13Jan2021, blood pressure: fluctuated in Jan2021, uric acid levels: high on unspecified date, body temperature: 102.2 F on 13Jan2021, body temperature: 98.8 F on 13Jan2021, COVID-19 virus test: positive on 16Jan2021. Therapeutic measures were taken as a result of the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/01/2021,,WRK,ALLOPURINOL; LISINOPRIL,Blood pressure high; Gout,,,,"['Blood pressure fluctuation', 'COVID-19', 'Condition aggravated', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018594,,26.0,F,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a non-contactable consumer or other non hcp reported for her daughter. A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included hypertension, asthma, hypersensitivity. It was unknown if the patient was pregnant at time of vaccination. Prior to vaccination the patient was not diagnosed COVID-19 positive. The patient's concomitant medications were not reported. The patient had a covid tested positive on 06Jan2021 with outcome of recovering. The patient was previously tested negative on 04Jan2021. Facility where she worked had outbreak. The events resulted in both emergency room visit and physician office visit. She was improving but her respiratory status still wasn't good. Pulmonologist just restarted 2nd round of steroids, and additional BP med started. Can now sit up but quickly gets wiped out. She was not currently hospitalized. No follow-up attempts are possible. No further information is expected. Batch/Lot numbers can not be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/06/2021,8.0,UNK,,,"Medical History/Concurrent Conditions: Allergy (known allergies: yes, but specifics unknown); Asthma; Hypertension",,,"['COVID-19', 'Respiratory disorder', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1018619,FL,67.0,M,"looks like a cold, dizzy, slight fever, feels weakness; looks like a cold, dizzy, slight fever, feels weakness; looks like a cold, dizzy, slight fever, feels weakness; looks like a cold, dizzy, slight fever, feels weakness; I feel not so good; cough; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer reported for himself. A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EK9231 on 11Jan2021 at single dose for COVID-19 immunization. The second dose of vaccine was scheduled on 02Feb2021. The patient had no medical history. Concomitant medications were not reported. Beginning on Friday, 22Jan2021, he started having symptoms that ""looks like a cold, dizzy, slight fever, feels weakness"", ""I feel not so good"" and cough. On unknown date in Jan2021 the patient was positive to SARS-CoV-2 test. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/01/2021,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'COVID-19', 'Cough', 'Dizziness', 'Malaise', 'Nasopharyngitis', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018635,,,F,"infected by covid on 07Jan; infected by covid on 07Jan; This is a spontaneous report from a contactable Other Health Professional (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was infected by covid on 07Jan2021 and tested positive for COVID-19 on 07Jan2021. She was given Zanamivir (was not able to verify) on 12Jan2021, started with Bamlanivimab antibodies treatment on 12Jan2021 and has fully recovered from COVID in Jan2021 since then as it was a mild form only. The patient would like to get the second dose as soon as possible, second dose of the vaccine was scheduled for 12Jan2021. She is looking on guidance on pursuing the second dose of the vaccine. Serious: No. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 test positive and drug ineffective due to temporal relationship. This case will be reassessed once additional information is available.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,01/07/2021,16.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018652,FL,31.0,F,"Still getting heat rashes; Had an anaphylactic reaction; Feels tired all day; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration in arm left on 22Jan2021 09:30 at single dose for COVID-19 immunisation. Medical history included Hashimoto's disease. The patient's concomitant medications were not reported. The patient previously took HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL, number of previous doses: 3), and clindamycin and experienced allergic to clindamycin. The patient experienced an anaphylactic reaction on 22Jan2021 09:45 requiring treatment with an Epipen and transportation to the hospital, heat rashes up until last night 24Jan2021, and felt tired all day in Jan2021. Patient was ""worried about how much benadryl"" she had been taking. Patient went to the emergency room (ER), received some treatment and was released after 5 hours. She was not fully recovered. She was still experiencing rashes and felt tired all day. Treatment received for events anaphylactic reaction and heat rashes. The patient underwent lab tests and procedures which included blood work: normal on 22Jan2021, and white cell count: slightly increased on 22Jan2021. Outcome of event anaphylactic reaction was resolving, and of other events was not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/01/2021,,PHM,,,Medical History/Concurrent Conditions: Hashimoto's disease,,,"['Anaphylactic reaction', 'Blood test normal', 'Fatigue', 'Miliaria', 'White blood cell count increased']",1,PFIZER\BIONTECH, 1018657,IL,60.0,F,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer reported for herself. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL3249, exp.date May2021 on 15Jan2021 16:00 at single dose for COVID-19 immunization, via unspecified route of administration at the left arm. The patient had get earlier in January a DPT (diphtheria, pertussis, and tetanus) vaccine in the left arm. The patient had have a Pneumonia and Shingles vaccines in the last 2 years and she had no problems in past with vaccines, but stated she did get a little bit of swelling and had to put heat to the area with vaccines, but never had a fever afterwards. The patient had not medical history. Concomitant medications were not reported. No other vaccines given the same day. Since 16Jan2021, he started having symptoms, fever, cough and Diarrhea. On 17Jan2021 the patient was positive to SARS-CoV-2 test. On 19Jan2021 she received monoclonal antibody therapy. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/17/2021,2.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['COVID-19', 'Cough', 'Diarrhoea', 'Pyrexia', 'SARS-CoV-2 test positive', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 1018675,CO,22.0,F,"3 inch lesion. Red, swollen, hot and painful. Grew ins ice over 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/08/2021,0.0,UNK,Hydroxyzine Mono-Linyah,,,,Peanuts Shellfish,"['Erythema', 'Pain', 'Skin lesion', 'Skin warm']",2,MODERNA,IM 1018679,,65.0,F,"site of injection developed a bump and itchy rash. The area became red and blotchy. The bump disappeared after two days, The rash and itch lasted 5 days, it disappeared the day after I took a Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/30/2021,7.0,PUB,"Armour Thyroid, Zyrtec, Multi-vitamin, calcium, melatonin",Not applicable,"Breast Cancer survivor (2008), high count white blood cells.",temporary minimual pain on injection site.,"Demoral, mango (lips get inflammed)","['Injection site erythema', 'Injection site rash', 'Rash macular']",1,MODERNA,SYR 1018681,,,F,"she has covid; she has covid; This is a spontaneous report from a contactable Nurse reporting for herself and also received from the Nurse via a Pfizer-sponsored program. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. She was supposed to get the 2nd dose yesterday on 24Jan2021, but was unable to get it since she was on quarantine. The patient mentioned that she had covid on an unknown date in Jan2021, and asking when and where she can get it and if she had to wait 30 days from covid detection, and also asked if the vaccine has made she more susceptible to covid. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/01/2021,,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 1018683,VA,41.0,F,"Horrible muscle and nerve pain in lower extremities. Burning sensation with shooting pain, numbness, and tingling in lower extremities. Feet contract and I am unable to walk on them if I do not keep them flat.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,PVT,Levothyroxine 100 mcg,None,Hypothyroidism,,"Bacterium, Tetracycline","['Burning sensation', 'Gait inability', 'Myalgia', 'Neuralgia', 'Pain', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 1018684,NY,29.0,F,"tested positive with covid-19; tested positive with covid-19; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received the 1sy dose of bnt162b2 (BNT162B2, Batch/lot # E23249) at single dose at left arm on 11Jan2021 for Covid-19 immunisation, as being a teacher. Medical history was none. There were no concomitant medications. The patient was tested positive with covid-19 on 19Jan2021. On 19Jan2021 she took a rapid test and a PCR: the rapid test came back negative the PCR test came back positive (received on 22Jan2021, as reported). The outcome of events unknown. She asked if she can still receive the second dose or what to do if she would miss the receipt of the second dose of the COVID-19 vaccine due to isolation measure, and if she get excluded or if she need to get revaccinated?. A Product Complaint was filed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/19/2021,8.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018685,FL,67.0,F,"COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. A 67-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 09Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 virus test positive on 18Jan2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 18Jan2021. She was still sick. The information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/18/2021,9.0,UNK,,,,,,"['COVID-19', 'Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018686,NC,56.0,F,"within first 24 hours: headache, loss of appetite. within 36 hours: increased headache (moderate-severe), fatigue, loss of appetite. within 72 hours symptoms subsided",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,WRK,"Metoprolol, Lamictal, fish oil, lavender oil, multi vitamin, calcium plus D, NAC, turmeric, elderberry, Zyrtec, sonata",environmental/seasonal allergies,"hypertension, bipolar depression, insomnia",,"Latex, gluten sensitivity, multiple medication intolerances","['Decreased appetite', 'Fatigue', 'Headache']",1,PFIZER\BIONTECH,IM 1018690,CA,27.0,M,6 days after the first dose i've noticed swelling of lymph nodes. Supraclavicular lymph nodes are swollen and sore to touch as well as swollen lymph nodes under my left arm pit. The Calvicular lymph nodes is also located on the left side. The same as the injection point.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/07/2021,5.0,MIL,None,none,none,,"Ceclure ,Chicken and Turkey","['Lymph node pain', 'Lymphadenopathy']",UNK,MODERNA,IM 1018693,ID,30.0,F,"Large, hot, red circle that appeared within 24 hours of shot, at site.. It was painful, hard and grew in size for 2-3 days before slowly subsiding. As of 2/9/2021, there is still occasional itching at the site, no redness but still a little muscle ""stiffness"".",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/28/2021,1.0,PVT,Vilazodone Buspirone Glipizide Eszopiclone,None,Type 2 diabetes,,None,"['Injection site erythema', 'Injection site pruritus', 'Musculoskeletal stiffness', 'Vaccination site induration', 'Vaccination site mass', 'Vaccination site pain', 'Vaccination site warmth']",1,MODERNA,SYR 1018696,MS,67.0,F,"Red, itchy rash over body, numbness in face and lips, red, itchy eyes this lasted for about 20 minutes, then began to subside - the swelling and numbness in face and lips first and then the itching of rash - rash went away and also itching and redness in eyes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,OTH,None,None,Seasonal allergies,,Azithromycin,"['Eye pruritus', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Ocular hyperaemia', 'Rash', 'Rash erythematous', 'Rash pruritic']",1,PFIZER\BIONTECH,SYR 1018699,,,F,"she tested positive for COVID yesterday at work; she tested positive for COVID yesterday at work/started to have a fever last night/now she has loss of sense of smell; This is a spontaneous report from a contactable nurse (patient). A 65 (age units: unknown) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that she received first dose of vaccine on Saturday approx. 9 days ago. The patient reported that she tested positive for COVID yesterday (on 24Jan2021) at work. The patient reported that she has started to have a fever last night (on 24Jan2021) and now she has loss of sense of smell (in Jan2021). The patient would like to know the efficacy of vaccine after first dose. The patient would like to know if she should get second dose after testing positive post first dose. Second dose scheduled for 10Feb. The events were reported as non-serious. The outcome of events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,01/24/2021,8.0,UNK,,,,,,"['Anosmia', 'COVID-19', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018700,CA,72.0,F,"Only slight soreness at injection site for a day, but then I noticed 10 days later a red rash 3 inches wide and about 5 inches long extending from the injection site down my arm. Very slightly itchy. No fever, no chills, no systemic symptoms, no pain. Today, on day 12, only 20% of the rash remains, and it is fading (now only slightly pink). In other words, it is disappearing. I noticed it on day 10, but don't know when it started-- probably a couple of days before that. It wasn't there on day 2.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,02/06/2021,9.0,PUB,Nature Made Women's Mulit+ Vitamins (OTC),none,"very sensitive to air pollution, chondromalacia patella right knee, exercise-induced asthma",,none,"['Injection site discomfort', 'Injection site erythema', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 1018701,,60.0,F,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had pcr positive/tested positive in Jan2021 with outcome of unknown. She specified doing her test an hour and a half after vaccination. She then described doing two additional PCR tests, one that same night and the other the next day, and both came out negative. She added she ""had no symptoms from the shot"". She asked if the COVID-19 vaccine can cause a false positive PCR test. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018704,NJ,68.0,F,"Erythema to face and chest starting at 8:15pm, about 4 hours after injection. Took Benadryl at 8:30pm. Redness mostly resolved by 10:30pm",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,02/09/2021,0.0,UNK,Losartan Simvastatin,N/a,"History of hypertension and hyperlipidemia, currently controlled",,"IV Contrast, Penicillin, Shellfish",['Erythema'],1,MODERNA, 1018708,FL,69.0,F,Itchy rash at vaccine location that appeared 8 days after vaccine. Itching lasted 4 days. Used hydrocortisone cream for relief.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,02/04/2021,6.0,PUB,"Gabepentin, Ropinerole, Fluoxitine, Atorvastatin, Omeprazole, Flexaril, Echinacea, Propolis, chlorpheniramine, multiple vitamin",None,"Depression, restless leg syndrome, arthritis",,Penicillin,"['Injection site pruritus', 'Injection site rash']",1,MODERNA,SYR 1018709,NY,,M,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced first symptoms of headache, vertigo, loss of smell and taste on 08Jan2021. The patient tested positive for covid-19 on 10Jan2021. The patient reported the Saturday before the Pfizer-BioNTech vaccine was administered, he tested negative for COVID-19 disease with a rapid test, but felt it was possible he had COVID-19 disease but it was so recent that the rapid test may have not been accurate. He reported being mostly recovered from his symptoms at this time with some tiny headache remaining. The outcome of the event was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/10/2021,4.0,UNK,,,,,,"['Ageusia', 'Anosmia', 'COVID-19', 'Headache', 'SARS-CoV-2 test negative', 'SARS-CoV-2 test positive', 'Vertigo']",1,PFIZER\BIONTECH, 1018711,NY,44.0,F,I went to sleep for four hours when I woke up I had a hard time walking. My legs were sore for about 24-36 hours. I was very tired for about 7 days all I did was sleep.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,WRK,"I take hydrochlorathiazide, and topomax",None,Migraines,,None,"['Fatigue', 'Gait disturbance', 'Hypersomnia', 'Pain in extremity', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 1018715,CA,39.0,F,"Delayed rash, swelling and hot but not itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/09/2021,8.0,PUB,,,Asthma,,,"['Feeling hot', 'Rash', 'Swelling']",1,MODERNA,IM 1018718,,22.0,M,Body rash and redness,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/09/2021,02/09/2021,0.0,UNK,Na,,,,NKDA,"['Erythema', 'Rash']",UNK,PFIZER\BIONTECH, 1018721,NY,,F,"COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. This consumer reported 2 reports for herself and her husband. This is the 1st of 2 reports. A 71-year-old female patient received the first dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 16Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In Jan2021, shortly after the first dose, the patient experienced COVID-19 virus test positive. Therapeutic measures were taken as a result of the event and included treatment with monoclonal antibodies on 24Jan2021. She was scheduled for the second dose on 09Feb2021. The information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092581 Same reporter/drug, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018723,TX,18.0,F,"2/9 1pm swelling of rt lymph nodes in neck 8pm 100.4 temp - tylenol & difficulty breathing when laying down - albuterol inhaler, humidifier 02 at 97-99",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/09/2021,1.0,PVT,,,Asthmatic,,Tamiflu Kiwi,"['Dyspnoea', 'Lymphadenopathy']",2,MODERNA,IM 1018724,,,F,"sharp stabbing pain in the back of my neck, my head, neck and upper back felt compressed; sharp stabbing pain in the back of my neck, my head, neck and upper back felt compressed; sharp stabbing pain in the back of my neck, my head, neck and upper back felt compressed; I couldn't turn my head , arms became stiff and I couldn't move my arms; I couldn't turn my head , arms became stiff and I couldn't move my arms; I couldn't turn my head , arms became stiff and I couldn't move my arms; she started having the sense of hotness and burning; she started having the sense of hotness and burning; This is a spontaneous report from a contactable nurse (who reported for herself). A 38-year-old female patient received bnt162b2 PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history was not reported. The patient's concomitant medications were not reported. She reports, ""sharp stabbing pain in the back of my neck, my head, neck and upper back felt compressed, I couldn't turn my head, arms became stiff and I couldn't move my arms. States she was put in a wheelchair and taken to the ER when she started having the sense of hotness and burning, stating ""it was unbearable. She reports that this subsided over the next couple of hours. Most scariest thing of my life."" Reports that she has not spoken to her Primary care doctor because she doesn't think they would know what to do. She reports that she works for 2 infectious disease doctors and spoke with her Allergist who just told her this was an adverse event. The clinical outcome of the events sharp stabbing pain in the back of my neck, my head, neck and upper back felt compressed, couldn't turn my head , arms became stiff and I couldn't move my arms, Feeling hot, Burning sensation was unknown. Information on Lot/Batch number has been requested.; Sender's Comments: Based on a compatible temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Burning sensation', 'Discomfort', 'Fear', 'Feeling hot', 'Head discomfort', 'Headache', 'Mobility decreased', 'Muscle tightness', 'Musculoskeletal discomfort', 'Musculoskeletal disorder', 'Musculoskeletal stiffness', 'Neck pain']",1,PFIZER\BIONTECH, 1018737,,,M,"COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 05Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 virus test positive (medically significant) on 07Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 07Jan2021. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/07/2021,2.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018740,,,F,received the first dose of the Pfizer vaccine on 05Jan2021 and was diagnosed with covid on 10Jan2021; received the first dose of the Pfizer vaccine on 05Jan2021 and was diagnosed with covid on 10Jan2021; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on 05Jan2021 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was diagnosed with Covid on 10Jan2021. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive on 10Jan2021. She has been back to work on 25Jan2021 and was currently Covid free. The outcome of events was unknown. She was scheduled to take the second dose of the vaccine on 26Jan2021 and wanted to know if she can receive it or would need to wait considering her situation. Filing potential AE report for review. Lot and batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/10/2021,5.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018748,,,M,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). This male patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID19 after getting the first shot and wanted to know if doctor will proceed with his second dose. Event outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018752,,,M,"patient was diagnosed with COVID-19; patient was diagnosed with COVID-19; This is a spontaneous report from a contactable consumer (patient's mother). A 23-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on an unspecified date for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was diagnosed with COVID-19 on an unspecified date with outcome of unknown (as reported). The event was described by reporter as follows: her son who received the first dose of the Pfizer vaccine, and is due for the second dose this weekend. Between the two doses the son was diagnosed with Covid, but currently is already doing fine according to the caller. She wanted to know if her son can take the second dose of the Covid vaccine as intended. The information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018755,CA,84.0,M,"Shaking chills, cold extremities, livedo reticularis on the thighs, lasted about 2 hours on the night of vaccination. Treated with tylenol. The next afternoon, he had documented ventricular tachycardia and his defibrillator fired 4 times in 1 hour, requiring EMS activation and hospitalization. His last ICD firing prior to that (only once) was in August 2020 and prior to that more than 2 years of no ICD firing.",Not Reported,,Yes,Yes,4.0,Not Reported,Y,02/05/2021,02/05/2021,0.0,PVT,"Baby Aspirin, pradaxa, dofetilide, carvedilol, imdur, furosemide, potassium, atorvastatin, latanaprost eye drops",Hypercalcemia due to hyperparathyroidism (normal now after treatment),"Coronary disease, Paroxysmal ventricular tachycardia (onset in 2009), Paroxysmal atrial fibrillation, HTN, diet controlled DM",,None,"['Cardiac assistance device user', 'Chills', 'Livedo reticularis', 'Peripheral coldness', 'Tremor', 'Ventricular tachycardia']",2,MODERNA,IM 1018774,,,F,"I received the first dose of the Pfizer Covid19 vaccine on 13Jan2021 and tested positive for Covid 19 on 19Jan2021.; I received the first dose of the Pfizer Covid19 vaccine on 13Jan2021 and tested positive for Covid 19 on 19Jan2021.; I had a 100.5 fever for one day; nasal congestion; aches and pains; stomach cramps; acid reflux; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 13Jan2021 for Covid-19 immunisation, as being a health care provider, a music therapist at a nursing home. The patient medical history and concomitant medications were not reported. The patient was tested positive for covid 19 on 19Jan2021 so she has been quarantining. In Jan2021 she had a 100.5 fever for one day, nasal congestion, aches and pains, stomach, acid reflux. The patient underwent lab tests and procedures which included body temperature: 100.5 fever, Sars-cov-2 test: positive on 19Jan2021. On 25Jan2021 was the best she has felt, where she was getting my energy back. As of 25Jan2021, her symptoms have been diminishing. She was told that if feeling better she could go and get retested on 29Jan2021, at urgent care. The outcome of was tested positive for covid 19 was unknown, of ad a 100.5 fever, nasal congestion, stomach cramps and acid reflux was recovering. Patient queried if she should still get second dose after testing positive after the first dose. She was scheduled for the second dose on 03Feb2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/01/2021,,UNK,,,,,,"['Abdominal pain upper', 'Body temperature increased', 'COVID-19', 'Gastrooesophageal reflux disease', 'Nasal congestion', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018784,LA,70.0,M,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246), via an unspecified route of administration in right shoulder on 15Jan2021 08:40 at single dose for covid-19 immunisation. Medical history included ongoing hypertension, family history of hypertension, blood cholesterol, drug intolerance (can't take statins for cholesterol), sleep disorder, back pain. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), zolpidem (unknown manufacturer), hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN). The patient had the first symptoms of congestion in the chest on 21Jan2021, fever of 101.2 degrees fahrenheit on 22Jan2021, has a little sinus issue and did not want to get up in Jan2021. He was tested positive for covid-19 on 23Jan2021. The outcome of the event was recovering. The patient was taking Tylenol due to the event. The event did not require visit to emergency room nor to physician office",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/23/2021,8.0,PVT,BYSTOLIC; ZOLPIDEM; HYDROCODONE/ACETAMINOPHEN,Blood pressure high,Medical History/Concurrent Conditions: Back pain; Blood pressure high; Cholesterol blood increased; Drug intolerance; Sleep disorder,,,"['COVID-19', 'Fatigue', 'Mobility decreased', 'Pyrexia', 'Respiratory tract congestion', 'SARS-CoV-2 test positive', 'Sinus disorder']",1,PFIZER\BIONTECH, 1018816,OH,75.0,F,"Bell's Palsy; This is a spontaneous report from a contactable physician and consumers reported that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not reported), via an unspecified route of administration on 09Jan2021 at a single dose for Covid-19 immunization. The vaccine was administered at a nursing home. Medical history included dementia, hyperlipidemia, hypothyroid, and drug allergy to penicillin; all from an unknown date. Patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took iodine and experienced drug allergy. The patient experienced bell's palsy on 15Jan2021. The reported event was resulted in Emergency room/department or urgent care. No treatment was provided for the event. The outcome of the event was recovering. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/15/2021,6.0,SEN,,,Medical History/Concurrent Conditions: Dementia; Hyperlipidemia; Hypothyroidism; Penicillin allergy,,,['Facial paralysis'],UNK,PFIZER\BIONTECH, 1018826,WA,45.0,F,Throat right and coughing a lot,Not Reported,,Yes,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PVT,"Throat thick, tight. Allergic reaction and went to ER and got steroids",No,"Migraine. Asthma, anemia, allergies, IBS, IC",,No,"['Blood test', 'Cough', 'Throat tightness']",2,PFIZER\BIONTECH,UN 1018854,,,M,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer Sponsored Program. A contactable male consumer of unspecified age reported that he received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date in Jan2021 the patient tested positive for COVID. He was supposed to come back on 27Jan2021 and was asking if it was possible to delay the second vaccine. Event outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018856,MO,,U,"First dose was not effective; This is a spontaneous report from a contactable Health Care Professional. A patient of an unspecified age and gender received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. It was reported that the first dose was not effective. The information on the lot number has been requested.; Sender's Comments: Based on the information provided, the drug ineffective cannot be excluded for vaccine BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination failure'],1,PFIZER\BIONTECH, 1018859,FL,,M,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer-sponsored program, Pfizert. A contactable male consumer of unspecified age reported that he received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 07Jan2021 the patient tested positive with Covid-19. He had to receive the second BNT162B2 dose on 26Jan2021. Event outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018863,NC,87.0,F,"COVID; COVID; This is a spontaneous report from a contactable consumer. An 87-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 maybe about 11:30am at single dose for COVID-19 immunization. Medical history included ongoing lung disorder started maybe 10 years ago or more, ongoing eye disorder onset may have been about 1 year ago, Carpel tunnel surgery on Jan2021 which was done on both wrists, ongoing weight decreased about 2 years ago, patient had cancer and has had some problems; they were going to the health clinics at the time and she had a horrible cough; she thinks, but does not know, if they did a bronchoscopy; but she saw some doctors and a cancer specialist. The patient had unknown concomitant medications for Thyroid. The patient was diagnosed with COVID 23Jan2021 and hospitalized in response which is ongoing. She is scheduled to get the second dose of Pfizer COVID-19 Vaccine on 27Jan2021. The patient body temperature is usually about 97.5 or 97.6 degrees Fahrenheit; but on Saturday: 23Jan2021 her temperature was 101.5 degrees Fahrenheit. Patient had her son take her to the hospital where they did the COVID test and it was positive for COVID; so she was admitted to the hospital for this on 23Jan2021. She is hospitalized at the same hospital where she was administered the first dose of Pfizer COVID-19 Vaccine and the hospital staff were shocked that she had gotten one of their Pfizer COVID-19 Vaccines. The patient was at the hairdresser's on 22Jan2021 who said the patient did not look good then; that she really looked sick; but apparently the patient did not have any symptoms 22Jan2021. It was not until unknown time on 23Jan2021 that her temperature went up; patient feels like her reaction is to the fever; where she just wants to sleep all the time. Patient probably does not have any energy. Caller does not hear her coughing when she talks to the patient. Caller clarified that to her awareness the patient's potential exposure to COVID positive persons would have been through the grocery store; or the health plex gym where caller and the patient go together but the patient said the health plex gym machines are spaced out well and there are no known exposures to COVID positive persons. Outcome of events was unknown.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/06/2021,01/23/2021,17.0,PVT,,Eye disorder (Verbatim: Eye problem); Lung disorder; Weight loss,Medical History/Concurrent Conditions: Cancer; Cough; Surgery; Thyroid disorder,,,"['Body temperature increased', 'COVID-19', 'Pyrexia', 'SARS-CoV-2 test positive', 'Somnolence']",1,PFIZER\BIONTECH, 1018885,OH,,F,"Caller received her 1st dose and in less than a week she was infected with Covid-19; Caller received her 1st dose and in less than a week she was infected with Covid-19; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her 1st dose and in less than a week she was infected with covid-19 on an unspecified date with outcome of unknown. The patient was asking if she needed to have the 2nd dose. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018889,CA,,M,Caller got first dose of Covid vaccine and got the virus; Caller got first dose of Covid vaccine and got the virus; Patient was late for his 2nd dose; This is a spontaneous report from a Pfizer sponsored program. A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced caller got 1st dose of Covid vaccine and then tested positive / he got the virus. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive an unspecified date. The outcome of events was unknown. Patient was also late for his 2nd dose and was wondering if he should still go get his 2nd dose. Information on lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018891,NC,,U,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a patient of unspecified age and gender received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID virus after receiving the first dose. Event outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018897,CA,,F,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 11Jan2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 25Jan2021, the patient was tested positive to COVID-19. Clinical outcome was unknown at time of this report. The information on the lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/25/2021,14.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018908,LA,,M,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient got sick and tested positive after the first vaccine dose. Event outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018910,SC,39.0,F,I am actually not certain which COVID vaccine she got but she came to our hospital having a stroke confirmed by CT,Not Reported,,Not Reported,Yes,,Yes,N,02/09/2021,02/09/2021,0.0,PVT,UNSURE,,NONE,,PENICILLIN,"['Angiogram cerebral abnormal', 'Cerebrovascular accident', 'Computerised tomogram abnormal']",UNK,PFIZER\BIONTECH, 1018911,WI,,F,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer-sponsored program. A contactable female healthcare professional of unspecified age reported that she received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021, for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 18Jan2021 the patient tested positive. She said that she was likely exposed already and had it when she got the first dose of the vaccine. She was asking if she can still get the second dose, she will be out of the quarantine on 28Jan2021. Event outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID-19 test positive based on the known safety profile. However the short duration of 3 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,,,UNK,,Exposure to COVID-19,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018916,IL,,F,"Got positive for the Covid-19 Virus after taking the Covid-19 vaccine; Got positive for the Covid-19 Virus after taking the Covid-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program, by a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 15Jan2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced got positive for the COVID-19 virus after taking the COVID-19 vaccine on 15Jan2021 with outcome of unknown . The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Jan2021. The information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/15/2021,0.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1018917,MI,,M,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer Sponsored Program. A contactable male consumer of unspecified age reported that he received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, after the first dose, the patient tested positive and lost his taste and smell. He also mentioned that his brother and mother were tested positive. Events outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Ageusia', 'Anosmia', 'COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018924,,,M,"COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for husband. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 10Jan2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced COVID-19 virus test positive on 19Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test positive on 19Jan2021. He was scheduled for the second dose on 31Jan2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/19/2021,9.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018928,NY,65.0,F,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 65-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation. Medical was none. There were no concomitant medications. The patient got covid positive/the covid-19 virus molecular test was positive on an unspecified date with outcome of unknown. On 20Jan2021 the patient started with the first symptoms of got very sick, had terrible body pain, sharp pain and aches, terrible cough, fever and felt completely like physically collapsed. The patient got positive covid-19 virus molecular test on 23Jan2021 with outcome of recovering. On 22Jan2021 the antigen test was negative. On 23Jan2021 the patient had also a negative flu rapid test.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/23/2021,9.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'Cough', 'Influenza virus test negative', 'Malaise', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018929,KY,56.0,M,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer Sponsored Program. A contactable male consumer (patient) reported for himself. A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL3248, exp date 30Apr2021, NDC number of COVID Vaccine: 59267-1000-2, on 07Jan2021 16:56 at 0,3ml single dose for COVID-19 immunization via unspecified route of administration at the left arm. The second dose of vaccine was scheduled on 28Jan2021. The patient medical history included Acid reflux. Concomitant medication included omeprazole for acid reflux, 20mg capsule once a day. Since Jan2021, the patient was violently sick one day, experienced diarrhea, puking and like a rock in his gut he could not get rid of. On 20Jan2021 he found out he had contracted COVID and tested positive for COVID. The outcome of the event was unknown. He has not had any additional COVID testing done since the one done on 20Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/20/2021,13.0,PVT,OMEPRAZOLE,,Medical History/Concurrent Conditions: Acid reflux (esophageal),,,"['Abdominal discomfort', 'COVID-19', 'Diarrhoea', 'Malaise', 'SARS-CoV-2 test positive', 'Vomiting']",UNK,PFIZER\BIONTECH, 1018936,NY,,F,"positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a Pfizer Sponsored Program. Information received from a contactable Consumer reporting for herself. A female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient had a positive covid-19 test on 19Jan2021 with outcome of unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/19/2021,6.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018942,CA,,F,"tested positive; tested positive; bronchitis; she has a problem with chest and coughing; she has a problem with chest and coughing; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received the 1st dose of dbnt162b2 (BNT162B2) at single dose on 08Jan2021 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive on 12Jan2021. In Jan2021 after taking the vaccine she experienced bronchitis and she has a problem with chest and coughing. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive on 12Jan2021. However, she was unsure if the virus is already in her system before taking the 1st dose of the vaccine. The patient claimed that she was now COVID free but her doctor told her that she was not recommended to take the 2nd shot of the vaccine after 21 days, but only after 90 days because she has a problem with chest and coughing. She confirmed that she experienced a bronchitis after taking the vaccine. The caller also mentioned taking Tessalon for cough and steroid pills as her doctor's recommendation. The outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/01/2021,,UNK,,,,,,"['Bronchitis', 'COVID-19', 'Chest discomfort', 'Cough', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018946,CO,,M,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer Sponsored Program. A contactable nurse reported that a male patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, 2 days after taking his first vaccine, the patient tested positive. Event outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive based on the known safety profile.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018952,,,F,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer of unspecified age reported that she received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient tested positive after the 1st dose of Covid vaccine and was wondering what to do about the 2nd dose. Event outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1018972,MT,,F,"Rash within an hour on neck, chest, wrists, knees, ankles.; Significantly swollen lymph node at base of neck and subclavicular lymph node on side of injection within 2 days.; Body aches; diarrhea; Swelling over anterior and posterior deltoid above site of injection, swelling across clavicle on side of injection within 3-4 days after injection; Swelling over anterior and posterior deltoid above site of injection, swelling across clavicle on side of injection within 3-4 days after injection; This is a spontaneous report from a non-contactable nurse (patient). A 50-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), via an unspecified route of administration started on 18Dec2020 18:15 at a single dose in left arm (as reported) for COVID-19 immunization. Medical history included chronic autoimmune inflammatory disorder, autoimmune hypothyroid, polycystic ovarian syndrome (PCOS), Raynauds, asthma, fibromyalgia. There were known allergies: some preservatives, several antibiotics, multiple foods. No Pregnant at the time of vaccination. Concomitant medication included loratadine (CLARITIN), famotidine, ergocalciferol (VIT D), nortriptyline, valaciclovir hydrochloride (VALTREX), received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Dec2020 19:00, the patient experienced rash within an hour on neck, chest, wrists, knees, ankles. significantly swollen lymph node at base of neck and subclavicular lymph node on side of injection within 2 days. body aches, diarrhea x 1 day. swelling over anterior and posterior deltoid above site of injection, swelling across clavicle on side of injection within 3-4 days after injection. Treatment, including ibuprofen (ADVIL), famotidine, clarithromycin (CLARITIN), heat, was received for adverse events. No COVID tested post vaccination. Since the vaccination, the patient was not tested for COVID-19. This is a non-serious report. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,12/18/2020,0.0,PVT,CLARITIN [LORATADINE]; FAMOTIDINE; VIT D; NORTRIPTYLINE; VALTREX,,Medical History/Concurrent Conditions: Allergy to antibiotic (known allergies: several antibiotics); Allergy to chemicals (known allergies: Some preservatives); Asthma; Autoimmune disorder; Autoimmune hypothyroidism; Fibromyalgia; Food allergy (known allergies: multiple foods); Polycystic ovarian syndrome; Raynauds,,,"['Diarrhoea', 'Injection site swelling', 'Lymphadenopathy', 'Pain', 'Rash']",1,PFIZER\BIONTECH, 1019006,NY,,M,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer who reported similar events for two patients. This is the second of two reports. Information were collected also from a Pfizer-sponsored program. A 74-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Shortly after the first dose the patient came down with COVID, tested positive for COVID in Jan2021. On 24Jan2021 he received monoclonal antibodies as treatment. He was scheduled for the second dose on 09Feb2021. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021070373 as same reporter/drug, different event/patient;US-PFIZER INC-2021070373 Same reporter/drug, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1019078,IL,37.0,F,"covid test date: 03Jan2021, covid test result: Positive; covid test date: 03Jan2021, covid test result: Positive; This is a spontaneous report from a contactable Other Health Professional (patient). A 37-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, lot # EJ1685) at single dose at left arm on 02Jan2021 11:45 for covid-19 immunisation. Medical history included post-traumatic stress disorder (PTSD), anxiety. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has received no other vaccines within 4 weeks prior to the COVID vaccine. On 03Jan2021 the patient has been tested for COVID-19 with rapid nasal swab test resulted positive. It was unknown if treatment was received. The outcome of events was unknown. Later the patient received the 2nd dose of bnt162b2 (BNT162B2, Lot # EL0140) at single dose at left arm on 23Jan2021 for covid-19 immunisation, administered at Pharmacy or drug store. The patient's concomitant medications in 2 weeks of this vaccination included: Lamictal, Klonopin, multivitamins, D, C, B, Zinc. On 24Jan2021 12:00 AM the patient experienced extreme tiredness, chills, fever, muscle aches, runny nose, sore throat, nausea, pale skin, malaise, night sweats. No treatment received for the adverse events. The outcome of events was recovering.; Sender's Comments: No effect of the suspect vaccine BNT162B2 could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,01/03/2021,1.0,PHM,,,Medical History/Concurrent Conditions: Anxiety; Post-traumatic stress disorder (PTSD),,,"['COVID-19', 'Chills', 'Fatigue', 'Malaise', 'Myalgia', 'Nausea', 'Night sweats', 'Oropharyngeal pain', 'Pallor', 'Pyrexia', 'Rhinorrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1019086,MA,57.0,F,"103.5 fever; severe back pain; body aches; Nausea; felt horrible; a girl touched her arm, said it was burning; This is a spontaneous report from a contactable nurse reported for herself. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) by injection once to right deltoid on 25Jan2021 at single dose for COVID-19 immunization. Medical history included she had COVID, she was diagnosed, was positive on 29Dec2020, and spent 9 days in the hospital. concomitant mediation was none. Patient calling about the COVID vaccine; her boss texted, she had to leave work, she had a 103.5 fever (26Jan2021), she felt horrible, she got her first COVID vaccine yesterday, and woke up this morning and felt horrible. a girl touched her arm, said it was burning, and she was very nauseous, and was trying to pass meds, and took her temperature and it was 103.5, and the thing is when you come into the facility, they took her temperature and it was 97.2, but those thermometers suck and she has an oral thermometer, and it was 103.5. It's improving. Also has severe back pain and body aches, she was scared with the fever. Felt nauseous this morning (26Jan2021), had chicken noodle soup and crackers, but it was pretty bad to point she had to pull the trash can behind her. she was on a ventilator in March for a week, not with COVID, she doesn't want to die, she thought she was going to die with COVID, she had every symptom. No Investigation Assessment. The last outcome of 103.5 fever, nausea and severe back pain was recovering, body aches was not recovered, outcome of other events was unknown. Reporter seriousness for 103.5 fever was Medically significant. For severe back pain, body aches and Nausea was Not serious. Relatedness of drug to reactions/events 103.5 fever, severe back pain, body aches and Nausea per source of assessment of Primary Source Reporter and Method of assessment of Global Introspection with drug result of Related.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event pyrexia and remaining events cannot totally be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,UNK,,,Medical History/Concurrent Conditions: COVID-19; Hospitalisation,,,"['Back pain', 'Body temperature increased', 'Burning sensation', 'Fear', 'Feeling abnormal', 'Impaired work ability', 'Nausea', 'Pain', 'Pyrexia', 'Skin warm']",1,PFIZER\BIONTECH, 1019096,PA,,U,"tested positive for Covid/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; 4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 4 patients, calling on behalf of another office. This report is for 4th of 4 patient. A patient of unspecified age and gender received the 1st and 2nd doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive for Covid after receiving the 2nd dose over 15 days before this report/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test 15 days after receiving the whole series on an unspecified date. The patient had no Covid symptoms, feeling fine after both doses. The patient underwent lab tests and procedures which included Sars-cov-2 test (rapid antigen test kit): positive. The outcome of events was unknown. Reporter was wondering if it was a false positive. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076785 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 1019099,,,U,"Having serious side effects; not feeling well; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was having serious side effects and patient just wanted to make sure if it's normal or patient should get concerned. The patient was not feeling well on an unspecified date. The event outcome was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,,,UNK,,,,,,['Malaise'],UNK,PFIZER\BIONTECH, 1019121,AZ,75.0,M,"some mild diarrhea; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; dry cough; This is a spontaneous report from a contactable consumer reported for himself. A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot EL3249 via unspecified route on 13Jan2021 at single dose for COVID-19 immunization. Medical history was none. Concomitant medications were not reported. On unknown date in Jan2021 the patient developed a dry cough and then some friends of him were tested positive for Covid-19 (further clarification unknown) and so on 22Jan2021 the patient got tested again and the result was positive. On 24Jan2021 the patient had some mild diarrhea and the temperature was normal. Consumer stated that he received as treatment some Zinc and Vitamin E and Vitamin C. The outcome of the events was unknown. The second dose was scheduled for 03Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'Cough', 'Diarrhoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1019131,CO,,F,"Patient developed mild COVID (positive test) 20 days after receiving 2nd shot; Patient developed mild COVID (positive test) 20 days after receiving 2nd shot; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unknown date at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. No COVID prior vaccination. On unknown date patient developed mild COVID (positive test) 20 days after receiving 2nd shot. The outcome of the event was recovering. Information about Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 1019142,,,F,"Anaphylactic reaction; I felt as if my throat was closing off; I have cramping feelings in my throat; felt as if my throat was closing off; I was very sick for 3 days; This is a spontaneous report from a contactable nurse. A nurse of unknown age reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), in Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. The nurse reported that she had her COVID 19 shot the past week and she reported her symptoms and wondered should not take the second dose because she was very sick for 3 days but that did not bother her. The thing that bother her was that she felt as if her throat was closing off, she had cramping feelings in throat. She was afraid that it was beginning to be 'anaphylaxis' but it was not. She reported that it did not go any further than that but she was fearful that her throat was going to close completely off. At the time of reporting the outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The suspected anaphylaxis with throat tightness and throat spasm were probably causally related to the use of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['Malaise', 'Muscle spasms', 'Throat tightness']",1,PFIZER\BIONTECH, 1019143,,,U,"Symptoms of COVID-19 all over again; Symptoms of COVID-19 all over again; Bad fever; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. This consumer reported 2 cases for different patients. This is the 2nd of 2 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history included COVID-19 (not ongoing). Concomitant medications were not reported. The patient experienced symptoms of COVID-19 all over again and bad fever all on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date, body temperature: fever on unknown date. The information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076695 Same reporter/product/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['COVID-19', 'Condition aggravated', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1019159,NC,60.0,F,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at arm right on 20Jan2021 at 10:00 at single dose for COVID-19 immunization. The patient medical history included diabetes from an unknown date and ongoing. The patient's concomitant medication included metformin. The patient experienced COVID-19 on 27Jan2021 (she got all the symptoms: sinus, headache, body aches, pain, chills, joint pain, fever). The patient was admitted to emergency room due to the event. The patient underwent lab test and procedure which included blood test and chest X-ray both on an unspecified date and both resulted that ""everything was good"" values not provided, in Jan2021 body weight: between 114-115 lbs, but probably 110 (lost a lot of weight in the past two weeks because of the virus) and SARS-CoV-2 test (nasal swab): positive on 27Jan2021. Therapeutic measures were taken as result of COVID-19 and included treatment with benzonatate (lot: 7893614, dose: 100 mg; one pill a day), ivermectin (dose: 3 mg, 4 pills a day for 2 days, exp: 28Apr2021), prednisone (dose: 20 mg, 3 tablets once daily lot: 7893618 ), azithromycin (dose: 500 mg, for five days, lot: 7893308). Medications she was prescribed in the emergency room were helping a little bit. The patient outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/27/2021,7.0,MIL,METFORMIN,Diabetes,,,,"['Arthralgia', 'Blood test normal', 'COVID-19', 'Chest X-ray normal', 'Chills', 'Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive', 'Weight decreased']",1,PFIZER\BIONTECH, 1019162,MO,30.0,F,"Anaphylaxis; persistent throat swelling; nasopharynx/oropharynx edema; difficulty breathing; difficulty swallowing; choking sensation; This is a spontaneous report from a contactable Physician. A 30-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The relevant medical history included known allergies: sulfa from an unspecified date. Concomitant medications were not reported. The patient experienced anaphylaxis: followed by persistent throat swelling, nasopharynx, oropharynx edema causing recurrent difficulty breathing, choking sensation and difficulty swallowing on 14Jan2021. The events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient underwent lab test included Covid which showed negative on an unspecified date post vaccination. The outcome of the events was unknown.; Sender's Comments: Based on a close chronological association a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,,Not Reported,U,01/14/2021,01/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,"['Anaphylactic reaction', 'Choking sensation', 'Dysphagia', 'Dyspnoea', 'Pharyngeal oedema', 'Pharyngeal swelling', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 1019176,,80.0,F,"After 2 weeks of received 1st dose COVID19 vaccine the patient presented to the hospital with a chief complaint of slurred speech, diffuse rash and headache. Found to have diffuse petechiae. Platelet count was < 2. CT head was significant for bifrontal and parafalcine subdural hematoma and scattered subarachnoid hemorrhage. Assessed by the hematology team who stated presentation and lab work was consistent with immune thrombocytopenia. Patient now admitted to the ICU undergoing platelet transfusions and treatment with steroids and IVIG",Not Reported,,Yes,Yes,,Not Reported,N,01/01/2021,02/08/2021,38.0,PVT,Amlodipine Buproprion Coumadin Simvastatin Toprol,None,"HTN, HLD, antiphospholipid syndrome",,No,"['Computerised tomogram head abnormal', 'Dysarthria', 'Full blood count', 'Headache', 'Immune thrombocytopenia', 'Petechiae', 'Platelet count decreased', 'Platelet transfusion', 'Rash', 'Subarachnoid haemorrhage', 'Subdural haematoma']",UNK,PFIZER\BIONTECH, 1019245,MA,71.0,F,following the vaccination shot on same day 2/6/21 complaints of injection site pain and headache she was found deceased in her residence 2/8/21 8:00 am,Not Reported,,Yes,Not Reported,,Not Reported,U,02/06/2021,02/06/2021,0.0,PVT,"cilostazol, rosuvastatin, oxybutynin, albuterol inhaler, spiriva inhaler",,"high cholesterol, copd",,,"['Death', 'Headache', 'Injection site pain']",2,PFIZER\BIONTECH,IM 1019268,MA,40.0,F,angioedema without urticaria 24h after COVID-19 vaccine (Moderna dose #1),Not Reported,,Yes,Yes,4.0,Not Reported,Y,02/05/2021,02/06/2021,1.0,UNK,amlodipine 5 mg b complex vitamins clonazepam 1 mg furosemide 80 mg gabapentin 400 mg insulin glargine 15U labetalol 400 mg pantoprazole 40 mg,Diabetic Ketoacidosis R Hand Necrosis with dry gangrene 2/2 steal syndrome from fistula,End Stage Renal Disease on Hemodialysis Type 1 Diabetes Hypertension Hepatitis C hx of IV Drug Use,,phenytoin - rash trazodone - not specified prochlorperazine - anaphylaxis (unable to verifiy),"['Angioedema', 'Complement factor C4', 'Immune complex assay', 'Tryptase']",UNK,MODERNA, 1019319,TX,52.0,M,Loss of movement in arm for several days. After 3 weeks I still have pain in my arm.,Not Reported,,Not Reported,Not Reported,,Yes,N,01/19/2021,01/20/2021,1.0,OTH,"Actos, Atorvastatin, Pioglitazone, Jardiance, Lisinopril, Gabapentin, Metformin, Vitamin B-12 and B-6",,Diabetes,,,"['Mobility decreased', 'Pain in extremity']",1,MODERNA,IM 1019334,,71.0,M,"Developed thrombocytopenia to 1 after vaccine, being treated for ITP",Not Reported,,Not Reported,Yes,,Not Reported,U,01/29/2021,02/06/2021,8.0,UNK,"Symbicort, montelukast, albuterol, hctz, benicar, nisoldipine",None,"HTN, HLD, asthma",,None,"['Platelet count decreased', 'Thrombocytopenia']",1,MODERNA,IM 1019335,AL,90.0,M,"Temp 103.5 temporal, myalgia, SOB, loss of balance, SpO2 85% RA lying down Symptoms appear to be resolving this AM. Sp02 98% on 2L O2. Temp 98 temporal - at 7:45am",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/09/2021,02/09/2021,0.0,PVT,"Trazodone, Aspirin 81mg, Gabapentin, Eliquis, Singulair","Productive cough, SOB Patient presented to ED with new onset temp 103.5, SpO2 85% on RA lying down","A-fib, CAD, CABG, CHF, Sleep apnea, PVD,",,"Clarithromycin, codeine","['Balance disorder', 'Body temperature increased', 'Chest X-ray', 'Dyspnoea', 'Metabolic function test', 'Myalgia', 'Oxygen saturation decreased', 'Rheumatoid arthritis', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 1019401,FL,42.0,F,ANAPHYLASXIS/DIFFICULTY BREATHING - ER EVALUATION AND 23 HR OBSERVATION; MED ADMINISTRATION OF EPI X3; BENADRYL; FAMOTIDINE; STEROIDS.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/10/2021,02/10/2021,0.0,WRK,,,,SOB/DIZZINESS,CLINDAMYCIN; VANCOMYCIN,"['Anaphylactic reaction', 'Dyspnoea', 'Full blood count', 'Metabolic function test']",2,MODERNA,IM 1019427,OH,56.0,F,Patient had anaphylactic reaction to vaccine and was given #2 Benadryl and #2 doses of Epi-Pen before being taken to hospital by EMS.,Not Reported,,Yes,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,SEN,Unkown,Unknown,Unknown,,Unknown,['Anaphylactic reaction'],2,PFIZER\BIONTECH,IM 1019446,KS,88.0,F,Was admitted to hospital on January 24th for unexplained weakness and dizziness - I noticed she was slurring her speech starting around the 20th of January. Hospital could not determine cause and she was released into nursing facility on the 28th. Did not recover. Received her second dose of Pfizer Covid vaccine at nursing home on Feb 4th. Starting having symptoms of slurred speech and became more weak. Labs on Feb 6th indicated very low hemaglobin levels and was admitted to the hospital on Feb 6th for transfusion. She is requiring transfusions of blood and iron. Possible ITP?,Not Reported,,Yes,Yes,8.0,Not Reported,N,01/11/2021,01/24/2021,13.0,SEN,"Multiple including: Metformin, Placid, high blood medicine includes other","Diabetes, high blood pressure other","Diabetes, high cholesterol, high blood pressure other",,None,"['Asthenia', 'Dizziness', 'Dysarthria', 'Haemoglobin decreased', 'Laboratory test', 'Transfusion']",1,PFIZER\BIONTECH,SYR 1019470,NY,56.0,F,"Pt. was requested to be vaccinated in the ""high risk clinic"" due to PMHX and concerns after the 1st vaccine. Apparently after 1st vaccine had persistent cough for days. Pt. presented for 2nd vaccine and vaccine was administered at 12:31p. Shortly after vaccine, she developed chest tightness, felt like her throat was closing and SOB at 12:42 p. Vitals B/P 145/88, Pulse 104, Resp 28, O2 sat 96%. She was asked to take 2 puffs of her albuterol inhaler and I administered epi 0.3 mg IM to R. thigh at 12:44 pm and Benadryl 50 mg IM to right deltoid. Medical First response was activated and responded within 2 min. She was immediately transferred next door to the ED under the care of Dr. In ED Decadron 10 mg IV and additional diphenhydramine 25 mg IV, and Famotidine 20 mg was administered. She was discharged home later that afternoon with course of po decadron and epipen. 2/5/21- Pt. is not returned to work d/t continued SOB and continues to f/u with PCP.",Not Reported,,Yes,Not Reported,,Not Reported,,02/04/2021,02/04/2021,0.0,PVT,"MVI, Protonix, Vit D, CA, Tumeric, Singulair, Asthmanax, Additional Meds on date of vaccine: Iron, Dulera, Claritin, Levothyroxine, Benadryl.",mastodynia,"Gerd, Hypothyroid, asthma, OSA, obesity, Anemia, TMJ, Tinnitus, Vocal cord paralysis, Env. Allergies.",,"morphine, zinc, zolpidem, flexeril, Iodine Contrast","['Chest discomfort', 'Cough', 'Dyspnoea', 'Impaired work ability', 'Throat tightness']",2,MODERNA,IM 1019513,NY,59.0,F,Experienced crescendo and decrescendo abdominal pain with pain scale of 8/10 . CT findings consistent with small bowel closed loop obstruction requiring exploratory laparotomy. Discharged from hospital 5 days after surgery.,Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/28/2021,02/03/2021,6.0,PVT,None,None,None,,Nuts,"['Abdominal pain', 'Explorative laparotomy', 'Pain', 'Small intestinal obstruction']",2,MODERNA,IM 1019548,,84.0,F,"Patient received her first covid vaccine on 1/27/21. on 1/30/21 she presented to the emergency department complaining of nausea, she had a negative work up, felt better and was sent home. on 2/5/21 she returned to the emergency department more ill-appearing and complaining of ""feeling sick"". she had fatigue, chills, decrease in activity level. her work up at this visit revealed multiple metabolic abnormalities, sepsis and bacteremia. She ultimately passed away at this visit with at cause of death listed as acute liver failure, pneumonia, and DIC>",Yes,02/06/2021,Not Reported,Yes,1.0,Not Reported,N,01/27/2021,01/30/2021,3.0,PVT,,,"CVA, hypertension, pulmonary hypertension, GERD",,,"['Acute hepatic failure', 'Asthenia', 'Bacteraemia', 'Chills', 'Death', 'Disseminated intravascular coagulation', 'Fatigue', 'Loss of personal independence in daily activities', 'Malaise', 'Metabolic disorder', 'Nausea', 'Pneumonia', 'Sepsis']",1,PFIZER\BIONTECH,IM 1019573,SD,81.0,F,"Systemic: Blood Disorder (diagnosed by MD)-Severe, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Other- Acute Kidney Injury, Hypoxia; lasted 10 days",Yes,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/19/2021,1.0,SEN,,,,,,"['Acute kidney injury', 'Blood disorder', 'Cardiac disorder', 'Hypoxia']",2,PFIZER\BIONTECH,IM 1019577,DE,82.0,M,Pt awoke on 2/8 feeling tired and weak. On 2/9 patient developed fever to 102 and shortness of breath and vomiting. Was seen in ER and admitted for presumed UTI as well as small PE.,Not Reported,,Not Reported,Yes,,Not Reported,N,02/02/2021,02/08/2021,6.0,PVT,"escitalopram, fludrocortisone, gabapentin, Klor-con, mestinon, northera, pravastatin, valacyclovir, velcade, zofran, centrum silver, vitamin B12, metamucil, caltrate plus D",no acute illness; undergoing treatment for multiple myeloma,"multiple myeloma, afib, CKD, sleep apnea, autonomic dysfunction / hypotension, urinary retention (requiring straight cath multiple times daily), hyperlipidemia",,none,"['Angiogram', 'Asthenia', 'Dyspnoea', 'Electrocardiogram normal', 'Fatigue', 'Laboratory test', 'Pulmonary embolism', 'Pyrexia', 'SARS-CoV-2 test negative', 'Urinary tract infection', 'Urine analysis abnormal', 'Vomiting', 'White blood cell count increased']",1,MODERNA,IM 1019581,AZ,83.0,F,"Lost consciousness, couldn't breathe, Kidney GFR dropped. Fluid in the lungs, Kidney damage. Still in hospital. No diagnosis at this time.",Not Reported,,Yes,Yes,7.0,Not Reported,N,01/22/2021,01/25/2021,3.0,OTH,One A Day 50+ Aspirin 325mg Senakot 8.6mg latanaprost .005% Levemir Flextouch Pen 3ml 5s100 u/ml Novolog Flexpen 5x3ml100 u/ml Rosuvastatin Tabs10 mg Olmesartan Medoxomil Tabs40 mg Furosemide Tabs20 mg Clonidine Hcl Tabs0.1 mg Bupropion Hcl,None,High Blood Pressure High Cholesterol Diabetes,,None,"['Blood test', 'Computerised tomogram', 'Dyspnoea', 'Glomerular filtration rate decreased', 'Loss of consciousness', 'Pulmonary oedema', 'Renal injury', 'X-ray']",1,PFIZER\BIONTECH,SYR 1019653,SC,68.0,F,6 days following vaccination patient had a left sided stroke-numbness in face arm and hand. went to ER. and stroke was confirmed,Not Reported,,Yes,Not Reported,,Not Reported,Y,01/21/2021,01/27/2021,6.0,SEN,"Diltiazem 180 mg, HCTZ 12.5mg, Valsartan320mg, loratadine10mg, fenofibrate 145mg, tolterodine 2mg, omeprezole, livalo 2mg",None,"HTN, hyperipedmia, GERD, seasonal allergies",,Statins- muscle aches,"['Cerebrovascular accident', 'Hypoaesthesia', 'Magnetic resonance imaging brain abnormal', 'Scan with contrast abnormal']",1,MODERNA,IM 1019661,,84.0,M,Patient admitted to hospital evening of 2/7/21 with acute ischemic stroke and received tenectaplase. Diagnosis Left MCA stroke. Reporting event given was just over 24 hours after first COVID vaccine dose.,Yes,02/01/2021,Yes,Yes,,Not Reported,U,02/06/2021,02/07/2021,1.0,PVT,"lipitor 20mg daily, zetia 10mg daily, HCTZ 12.5mg daily prn, lisinopril 20mg daily, vitamin d daily, motrin prn, magnesium oxide 400mg daily, MVI daily, fish oil daily, asa 81mg daily, eye drops (latanoprost, cosopt, prednisolone)","hip replacement, HLD, HTN, atherosclerotic heart disease, cataract surgery","hip replacement, HLD, HTN, atherosclerotic heart disease, cataract surgery",,NKA,"['Cerebrovascular accident', 'Ischaemic stroke']",UNK,PFIZER\BIONTECH, 1019663,NM,41.0,F,"Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Other- pt experiencing rt arm numbness, tingling, and difficulty using right hand; symptoms lasted 28 days",Not Reported,,Not Reported,Not Reported,,Yes,N,01/09/2021,01/10/2021,1.0,SEN,,,,,,"['Chills', 'Hypoaesthesia', 'Musculoskeletal disorder', 'Pain', 'Paraesthesia', 'Pyrexia']",1,MODERNA,IM 1019664,CO,75.0,F,"75-year-old woman who presented to the emergency room 2 days after vaccination with chest tightness, fatigue and was found to have pericardial effusion without tamponade. It was noted that patient has had intermittent syncope since August of 2020 and clinical interpretation is likely that pericardial effusion pre dated vaccination. In her workup for dizziness and syncope she had not previously undergone EKG, chest x-ray or echocardiogram therefore pericardial effusion could have been missed. I elected to report the pericardial effusion to be on the side of caution.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/05/2021,02/08/2021,3.0,PVT,"Gabapentin 300 mg at bedtime, metoprolol 25 mg daily, Effexor 75 mg daily",,"Hypertension, multiple sclerosis, depression",,Hydrochlorothiazide: Syncope,"['Blood culture', 'Catheterisation cardiac', 'Chest discomfort', 'Dizziness', 'Echocardiogram', 'Fatigue', 'Imaging procedure', 'Pericardial effusion', 'Serology test', 'Syncope']",2,PFIZER\BIONTECH,IM 1019669,CT,73.0,F,"the following morning the patient became unresponsive while taking a shower, became asystolic and died despite about an hour of ACLS and 8 rounds of epi",Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/09/2021,1.0,UNK,,,"heart failure with EF of 20-30%, coronary artery disease, type two diabetes, obstructive sleep apnea, diabetic nephropathy",,sulfonamides,"['Cardiac arrest', 'Death', 'Unresponsive to stimuli']",UNK,MODERNA,IM 1019670,WA,55.0,M,"2/2/2021- seen in Ed with c/o intermittent fever following 2nd dose. Redness to bilateral upper extremities, c/o some pain with urination, weak. V/S stable, afebrile in ED. Assess for infection. No significant abnormal labs (see below), hydrated and discharged. 2/4/2021- arrived in ED with c/o vomiting, seen earlier by PCP that day labs drawn. Shortly after arriving in the ED copious amouts of emesis noted, the patient went into full cardiac arrest and CPR was started. -Please see HPI above, in addition after intubation the patient coded again. More epinephrine and lidocaine were given. CPR was resumed. We did obtain ROSC and targeted temperature management was pursued. He is placed on a lidocaine drip and a right femoral central line was placed by myself. At this time, norepinephrine drip was initiated given his continued hypotension. Post intubation chest x-ray suggests possible abdominal pathology and once the patient was stabilized further, he was sent to the CT scanner where CT head without IV contrast and CT chest, abdomen and pelvis with IV contrast was obtained. He did lose pulses once in the radiology suite. This was brief. IV fluids were initiated and he received over 2 L of crystalloid therapy. He continued to be hypotensive in the emergency department and vasopressin was added. He also had a single dose of Neo-Synephrine and IV push fashion to help bring his blood pressure up. CT scan reveals probable bilateral aspiration pneumonia/pneumonitis and dilated loops of small bowel without a transition point and pneumatosis involving loops in the left upper quadrant. I did try to initiate consult with critical care and possible transfer, however he continued to be unstable and coded requiring CPR multiple times. He was given IV bicarbonate given his prolonged CPR state and pH. Ultimately, the family decided to make the patient comfort measures only given his critical illness. Shortly after making this decision he did pass away in the emergency department. RADIOLOGY DIAGNOSTIC - CHEST PORTABLE 02/04 2051 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2059 IMPRESSION: 1. Findings highly suspicious for portal venous gas which can be seen in the setting of bowel ischemia. Consider CT for further evaluation and/or surgical consultation. 2. Endotracheal tube 3.7 cm above the carina. 3. Low lung volumes with mild patchy perihilar opacities. Final Report Signed by: M.D., Sign Date/Time: 02/04/2021 8:55 PM Impression By: MD CT SCAN - CT HEAD WO 02/04 2140 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2200 IMPRESSION: Negative for acute intracranial process. No evidence of mass effect, acute hemorrhage or definite acute cortical infarct. Final Report Signed by: M.D., Sign Date/Time: 02/04/2021 9:57 PM Impression By: - MD CT SCAN - CT CHEST/ABD/PELVIS W 02/04 2140 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2214 IMPRESSION: 1. Ill-defined patchy opacities within the bilateral upper lobes, right middle lobe, in consolidative opacities within bilateral lower lobes which could represent aspiration, and/or multifocal pneumonia. 2. Small right trace left pleural effusions. 3. Diffusely dilated small bowel without a transition point and mucosal hyperenhancement involving the colon with areas of pneumatosis involving loops of small bowel within the left upper quadrant and portal venous air consistent with hypoperfusion complex. There is a small caliber appearance of the aorta and a flattened appearance of the IVC is well. 4. Intravascular air within the IVC and bilateral iliac veins could be secondary to right femoral central lying injection. 5. Somewhat abnormal enhancement pattern of the kidneys with hypoenhancement of the medullary pyramids which may suggest hypoperfusion injury as well. 6. Probable nondisplaced rib fractures on the right at ribs 2 through",Yes,02/04/2021,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/02/2021,6.0,PVT,,,"Cerebral Palsy, Anxiety, Crohns, Bipolar, GERD, Nutrition deficiency, Iron deficiency",,lactose,"['Alanine aminotransferase increased', 'Anion gap', 'Aspartate aminotransferase increased', 'Asthenia', 'Bacterial test positive', 'Base excess', 'Basophil count increased', 'Bilirubin urine', 'Blood albumin decreased', 'Blood alkaline phosphatase increased', 'Blood bicarbonate increased', 'Blood bilirubin normal', 'Blood calcium decreased', 'Blood chloride decreased', 'Blood creatine phosphokinase MB decreased', 'Blood creatine phosphokinase normal', 'Blood creatinine increased', 'Blood glucose increased', 'Blood lactic acid normal', 'Blood pH decreased', 'Blood potassium normal', 'Blood sodium decreased', 'Blood sodium normal', 'Blood urea increased', 'Blood urea nitrogen/creatinine ratio increased', 'C-reactive protein normal', 'Carbon dioxide decreased', 'Cardiac arrest', 'Chest X-ray abnormal', 'Chromaturia', 'Creatine urine increased', 'Crystal urine present', 'Death', 'Differential white blood cell count normal', 'Dysuria', 'Endotracheal intubation', 'Eosinophil count decreased', 'Erythema', 'Fluid overload', 'Full blood count normal', 'Globulins decreased', 'Glomerular filtration rate decreased', 'Glucose urine absent', 'Haematocrit normal', 'Haemoglobin decreased', 'Hypoperfusion', 'Hypotension', 'Immature granulocyte count increased', 'Influenza virus test negative', 'Intestinal ischaemia', 'Lipase', 'Lung opacity', 'Lymphocyte count normal', 'Mean cell haemoglobin concentration decreased', 'Mean cell haemoglobin normal', 'Mean cell volume increased', 'Mean platelet volume normal', 'Metabolic function test', 'Metamyelocyte percentage', 'Monocyte count decreased', 'Monocyte count normal', 'Neutrophil count', 'Neutrophil count normal', 'Nitrite urine absent', 'Opiates negative', 'Oxygen saturation decreased', 'PCO2 increased', 'PO2 normal', 'Platelet count normal', 'Pleural effusion', 'Pneumonia aspiration', 'Pneumonitis', 'Procalcitonin decreased', 'Protein total decreased', 'Protein urine present', 'Pulse absent', 'Pyrexia', 'Red blood cell count decreased', 'Red blood cell sedimentation rate normal', 'Red blood cells urine', 'Red cell distribution width increased', 'Resuscitation', 'Rib fracture', 'SARS-CoV-2 test negative', 'Small intestinal obstruction', 'Specific gravity urine normal', 'Toxicologic test normal', 'Troponin I normal', 'Urinary casts', 'Urinary lipids present', 'Urinary occult blood positive', 'Urine analysis', 'Urine analysis abnormal', 'Urine analysis normal', 'Urine ketone body present', 'Urine leukocyte esterase', 'Urobilinogen urine', 'Vomiting', 'White blood cell count normal', 'White blood cells urine positive', 'pH urine normal']",2,PFIZER\BIONTECH,IM 1019768,MA,72.0,F,"Started feeling unwell several days after shot. Chills fever soaked bed sheets and had to call in sick from work. Did telehealth visit with primary who recommended Covid test which came back negative. Primary advised going to Hospital emergency room for tests-she has been in hospital with pnemonia for 14 days and is now in ICU. Drs treating with high dose steroids, antibiotics and high dose oxygen. She is not recovering.",Not Reported,,Yes,Yes,14.0,Not Reported,N,01/16/2021,01/20/2021,4.0,PVT,"Metformin, Omeprazole, Rosuvastatin, Fluoxxetine, Triamterene, Olmesartan Medoxomil",None other than had one other negative Covid test due to general malasise after the holidays,"prediabetes, heart murmur, high blood pressure, lung scarring",,not known allergies,"['Bacterial test negative', 'Blood test', 'Chills', 'Hyperhidrosis', 'Impaired work ability', 'Intensive care', 'Malaise', 'Pneumonia', 'Pneumonitis', 'Pyrexia', 'Rheumatoid factor negative', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH,IM 1019773,TX,70.0,F,"Chest and body aches, new onset afib with RVR upon admission",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/06/2021,02/06/2021,0.0,PVT,"Azithromycin, Benzonatate, dexamethasone, ergocalciferol, ixazomib, lenalidomide, pantoprazole, valacyclovir",,Relapsed multiple myeloma,,Penicillin,"['Atrial fibrillation', 'Blood test', 'Chest pain', 'Echocardiogram', 'Electrocardiogram', 'Full blood count', 'Hepatic enzyme', 'Pain']",UNK,PFIZER\BIONTECH,IM 1019850,IL,76.0,M,"HPI Patient is a 77 y.o. male who presents with in full cardiac arrest. Patient is resident of local nursing home. According to nursing home staff, a tech was in his room talking with him as patient was laying in bed. Tech began walking out of patient's room and turned around to tell him one last thing when the tech noticed patient had gone unresponsive. Patient had no spontaneous respirations or pulse, subsequently CPR was started immediately. 911 was called. This occurred around 5:30 a.m.. � Upon EMS arrival on scene, they found a male unresponsive with CPR being performed. There was no spontaneous respirations or circulation. Thus, ET tube was placed and ACLS guidelines initiated. Patient was found to be in PEA, and according to EMS, patient was given a total of 6, 1 mg epinephrine IV push and 1, 1 Amp sodium bicarb. Patient was worked on at the scene for approximately 40 min before being transferred to ER. � Upon arrival to ER trauma room 1 patient is still in full arrest. ET tube in place with good ventilation. Patient remains in PEA. Chest compressions and ACLS guidelines initiated. � In reviewing patient's chart and nursing home notes, patient is a full code. Patient has a significant cardiac history including known coronary artery disease with 4 vessel CABG. Patient also has history of 3rd degree heart block and pacemaker placement. Patient has history of ischemic cardiomyopathy but last echo performed in 2020 shows ejection fraction of 45%.",Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,02/10/2021,42.0,SEN,,,,,sulfa,"['Blood sodium decreased', 'Cardiac arrest', 'Endotracheal intubation', 'Pulse absent', 'Resuscitation', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 1019887,GA,82.0,M,ON DAY OF VACCINE NO PRESENTATION OF SIGNS OR SYMPTOMS OF ILLNESS. PRESENTED WITH FEVER AND SYMPTOMS OF UTI ON 2/5/2021. PCR COVID TEST POSITIVE. SUDDEN HYPOXIA ON 2/6/2021. TRANSFERRED AND ADMITTED TO MEDICAL CENTER.,Not Reported,,Not Reported,Yes,5.0,Not Reported,N,02/03/2021,02/05/2021,2.0,OTH,"solumedrol IV, lisinopril, levemir, asprin, lipitor",URINARY INCONTINENCE UTI DEMENTIA DM CKD,DEMENTIA B-12 DEFICIENCY CKD STAGE 3 DM PERIPHERAL ARTERIAL DISEASE NPDR DRY AMD CATARACTS,,NO KNOWN ALLERGIES,"['COVID-19', 'Hypoxia', 'Pyrexia', 'SARS-CoV-2 test positive', 'Urinary tract infection']",1,MODERNA,IM 1019911,WI,77.0,M,Client was administered the vaccine while symptomatic (01/25/21) although client did not know he was symptomatic for COVID-19. He had been exposed to a family member who had tested positive and should have been in quarantine but wasn't either because it was not felt he was considered a close contact by his family opinion or his family member never notified public health of this close contact...?. Clinet had presented to the ED following day after vaccination for shortness of breath and fatigue and an antigen test showed he was positive for COVID-19. He was sent home that same day 01/26/21. He was back in ED on 01/28/21 for worsening symptoms and admitted to hospital and later placed on ventilator. He passed away on 02/09/2021 (date of death was per his wife).,Yes,02/09/2021,Not Reported,Yes,12.0,Not Reported,,01/25/2021,02/09/2021,15.0,UNK,,Tested positive for COVID-19 on 01/26/2021 (Antigen positive) - presented to ED due to shortness of breath and fatigue,"Active Problems Noted Date Hypokalemia 1/28/21 Pneumonia due to COVID-19 virus 1/28/21 Acute hypoxemic respiratory failure 1/28/21 Stone of salivary gland or duct 1/8/21 Recurrent major depressive disorder, in partial remission 1/7/21 Secondary hyperparathyroidism of renal origin 1/7/21 Abnormal blood smear 7/22/20 Alkaline reflux gastritis 1/2/20 Severe obesity (BMI 35.0-39.9) with comorbidity 12/20/18 Type 2 diabetes mellitus with diabetic neuropathy, without long-term current use of insulin 12/20/18 Morbid obesity due to excess calories 6/18/18 Psoriasis 12/13/17 Proteinuria 10/20/17 Bilateral leg edema 12/5/16 Hypertriglyceridemia 6/27/16 Essential hypertension with goal blood pressure less than 130/85 6/27/16 Anxiety, generalized 6/27/16 Hypothyroid 11/24/14 Aortic valve replaced 7/7/14 Pulmonary emphysema 1/22/09 Obstructive sleep apnea syndrome 8/4/1943 Resolved Problems Noted Date Resolved Date Other chest pain 10/29/19 10/30/19 Chest pain 10/29/19 10/30/19 Type 2 diabetes mellitus without complication, without long-term current use of insulin 6/24/19 7/6/20 Sialadenitis 1/4/19 1/2/20 Obesity (BMI 35.0-39.9 without comorbidity) 12/20/18 1/29/21 Abdominal pain 11/21/18 1/2/20 Type 1 diabetes mellitus with stage 3 chronic kidney disease 6/18/18 6/18/18 CKD (chronic kidney disease) stage 3, GFR 30-59 ml/min 10/20/17 1/2/20 Sarcoidosis of lung 6/27/16 6/26/20 Uncontrolled type 2 diabetes mellitus with stage 3 chronic kidney disease, without long-term current use of insulin 6/27/16 12/13/17 Overview: Recent onset HbA1C 4/21/16 11.9. Last FBS-110 5/17/16 Diabetic eye exam 9/23/16 no diabetic retinopathy. fup one year. Hypothyroidism (acquired) 6/27/16 12/13/17 Exertional dyspnea 6/27/16 6/26/20 Tobacco abuse 11/19/08 9/23/11 documented as of this encounter (statuses as of 01/29/2021) Patient Active Problem List Diagnosis ? Obstructive sleep apnea syndrome ? Pulmonary emphysema (*) ? Aortic valve replaced ? Hypothyroid ? Hypertriglyceridemia ? Essential hypertension with goal blood pressure less than 130/85 ? Anxiety, generalized ? Bilateral leg edema ? Proteinuria ? Psoriasis ? Morbid obesity due to excess calories (*) ? Obesity (BMI 35.0-39.9 without comorbidity) ? Severe obesity (BMI 35.0-39.9) with comorbidity (*) ? Type 2 diabetes mellitus with diabetic neuropathy, without long-term current use of insulin (*) ? Alkaline reflux gastritis ? Abnormal blood smear ? Recurrent major depressive disorder, in partial remission (*) ? Secondary hyperparathyroidism of renal origin (*) ? Stone of salivary gland or duct ? Hypokalemia ? COVID-19 virus infection ? Acute hypoxemic respiratory failure (*) Past Medical History: Diagnosis Date ? Anxiety ? Arthritis ? Asthma ? Back pain ? Chronic kidney disease, stage II (mild) 10/20/2017 ? Dependent edema ? DJD (degenerative joint disease) ? Gastritis ? Glucose intolerance (impaired glucose tolerance) ? History of pulmonary function tests 10/20/2010 showing decreased lung flow consistent with normal variant versus mild obstruction and emphysema ? History of stress test 12/2009 Normal ? Hyperlipidemia ? Hypothyroid Previously had hyperthyroidism ? Kidney stone 05/1999 Right ? Proteinuria 10/20/2017 ? Psoriasis ? Sarcoidosis ? Sleep apnea Past Surgical History: Procedure Laterality Date ? AORTIC VALVE REPLACEMENT 05/2001 #25 St. Jude's aortic valve replacement ? APPENDECTOMY 1960's ? CHOLECYSTECTOMY 1994 ? COLONOSCOPY 2010 ? COLONOSCOPY FLX DX W/COLLJ SPEC WHEN PFRMD N/A 11/21/2018 COLONOSCOPY with hot polypectomy snare ? OTHER SURGICAL HISTORY 09/2018 spot removed from left arm ? TOTAL KNEE ARTHROPLASTY Right 11/19/2012 ? UPPER GI ENDOSCOPY,DIAGNOSIS N/A 11/21/2018 EGD with cold biopsies performed ? WISDOM TOOTH EXTRACTION",,Review of patient's allergies indicates: Allergies Allergen Reactions ? Other [Uncoded Nonscreenable Allergen] Rash Neoprene,"['COVID-19', 'Condition aggravated', 'Death', 'Dyspnoea', 'Exposure to SARS-CoV-2', 'Fatigue', 'Mechanical ventilation', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1019913,TN,67.0,F,"Chest discomfort with high heart rate and shortness of breath, dizzy upon standing. In ER HR was 156 with atrial fibrillation with RVR. BP 146/89. 2/7/21 1546 - Patient complaining of left side peripheral field deficit, CT showed subacute right occipital lobe infarct",Not Reported,,Yes,Yes,,Not Reported,U,02/03/2021,02/07/2021,4.0,PVT,Lostartan 25mg PO Daily Lovastatin 20mg PO Bedtime Lortab 5-325mg PO BIDPRN Celecoxib 200mg PO Daily,,"Hypertensive disorder, Curvature of spine, Raynaud's disease, Degeneration of intervertebral disc, Arthritis, GERD","Moderna COVID19 Vaccine 1/4/21 @ 1031, headache, fatigue, sore arm",NKA,"['Atrial fibrillation', 'Cerebral infarction', 'Chest discomfort', 'Computerised tomogram head abnormal', 'Dizziness postural', 'Dyspnoea', 'Heart rate increased', 'Visual field defect']",1,MODERNA,IM 1019919,AZ,82.0,F,Had positive covid-19 test on 02/03/2021 via Rapid Abbott BinaxNOW Ag card. Patient denied any symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,02/03/2021,26.0,SEN,,,Parkinson's Disease,,Bactrim,"['COVID-19', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1019923,AZ,67.0,F,Pt was hospitalized with COVID-19 Pneumonia. Admitted on the 25th of January and treated with Remdesivir. Discharged to home on February 1st.,Not Reported,,Not Reported,Yes,7.0,Not Reported,,01/22/2021,01/25/2021,3.0,PUB,,,,,,['COVID-19 pneumonia'],UNK,PFIZER\BIONTECH,IM 1019942,LA,69.0,M,"SOB, coughing , BNP and BUN elevated. Covid REGN-Cov2 antibodies",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/03/2021,02/05/2021,2.0,OTH,"amiodarone, aspirin, insulin",no acute,"DM, HTN, hyperlipidemia, eye problems, defibrillator",,NKDA or other allergies,"['Blood creatine phosphokinase', 'Blood urea increased', 'Brain natriuretic peptide increased', 'Cough', 'Dyspnoea', 'Full blood count', 'Metabolic function test', 'SARS-CoV-2 test', 'Troponin']",1,MODERNA,IM 1019944,AZ,84.0,M,Patient tested positive for Covid-19 on 02/08/2021. Patient denies any symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/08/2021,3.0,SEN,,,"Lympedema, venous insufficiency, PVD, hyperlipidemia, HTN, heart disease, Afib",,PCN,"['COVID-19', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1019964,LA,80.0,M,The resident received his COVID-19 Moderna vaccination on 2/6/2021 2:11 pm and expired on 2/7/2021 at 6:04 am. There were no signs or symptoms of vaccination reaction leading up to death.,Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/07/2021,0.0,SEN,"Ferrous sulfate, Proteinex, Tylenol, Eliquis, Aspirin, Lipitor, Vitamin D3, Cholestyramine, finasteride, flavoxate, lactobacillus, loratadine, magnesium oxide, metoprolol, protonix, miralax, potassium cl, Tamsulosin, acetic acid (for foley)",Peg tube placement Malignant neoplasm of esophagus,"Attention and concentration deficit, Hyperlipidemia, Acute embolism thrombosis of Deep veins or upper extremity, cognitive communication deficit, cerebral infarction, Dysphagia, Thrombocytopenia, Obstructive and reflux uropathy, Hypomagnesemia, Allergic rhinitis, GERD, Hydronephrosis with renal and ureteral calculous obstruction, Benign prostatic hyperplasia with lower urinary tract symptoms, anemia, ulcerative pancolitis, cerebral cysts, chronic obstructive pyelonephritis, hypo-osmolality and hyponatremia, HTN, Vascular dementia with behavioral disturbances, DM II, Moderate protein-calorie malnutrition, Vitamin D deficiency, Folliculitis, Hypokalemia, Aphasia following cerebral infarction, metabolic syndrome",,None,['Death'],1,MODERNA,IM 1019979,MI,72.0,M,"Patient received the Moderna COVID vaccine 1/28/21. He was tested for COVID 19 on 1/29/31. Results were received 1/30/21, at which time he was evaluated and found to be hypoxic with tachycardia. He was sent to the local ER and returned this same day. On 2/2/21, he was evaluated by the provider, who sent him to the emergency room with acute respiratory distress and poor O2 sats",Yes,02/10/2021,Not Reported,Yes,8.0,Not Reported,N,01/28/2021,01/29/2021,1.0,OTH,ALBUTEROL HFA (8.5GM) 90 MCG INHA Exp: 05/06/2021 SIG: 90mcg Inhalation every four (4) to six (6) hours as needed x 180 day(s) -- Limited to two (2) canisters every six (6) months Artificial Tears Ophthalmic Solution 1.4 % Exp: 02/23/2021 S,Vitamin Deficiency,"GERD, COPD, HTN, Hyperlipidemia",,NKA,"['Acute respiratory distress syndrome', 'Death', 'General physical health deterioration', 'Hypoxia', 'Mechanical ventilation', 'Oxygen saturation abnormal', 'Respiratory distress', 'Tachycardia']",1,MODERNA,IM 1019999,MO,59.0,M,"Tested positive for COVID on December 31, 2020, Symptoms started on December 26, 2020,",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,12/23/2020,12/26/2020,3.0,PVT,"Metformin, lisinopril, simvastatin, Lantus, ASA, Claritin D, Vitamin D, Vitamin C, Elderberry Gummies,",,"Diabetes Type 2, HTN, Obese",,"Rocephin, erythromycin, sulfa drugs, Penicillin","['COVID-19', 'Chest X-ray', 'Full blood count', 'Influenza A virus test', 'Influenza B virus test', 'Metabolic function test', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1020002,OH,74.0,M,"Given First Moderna covid vacc 1/19/2021. Doing well on multiple contacts from health care providers, then 2/5/2021 was driving, pulled over to the side of the road into a yard, got out of the car and told an observer that he could not breathe, collapsed face down in the snow, EMS called, unable to revive him.",Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,02/05/2021,17.0,PVT,"Albuterol, Bumetanide, Metolazone, Candesartan, Carvedilol, Gabapentin, Insulin Pantoprazole, Tamsulosin, Warfarin",CHF,"CHF, DM, CAD, CKD, Sleep apnea, COPD",,cyclobenzaprine,"['Death', 'Respiratory arrest', 'Syncope']",1,MODERNA,IM 1020010,AZ,67.0,M,"Pt c/o coughing and SOB pt states he received 1st dose of covid vaccine on the 01/22/21 presented to the ED with fever, chills and shortness of breath. He tested positive for covid. In the ED he was hypoxic to 87% on RA. # Hypoxic respiratory failure: 2/2 covid pna. Room air sats 87%, up to 92% on 4L # COVID pneumonia: no suspicion for bacterial etiology. REMDESIVIR administration started on 1/25/21. Transferred to Hospital, (2/3/21) for higher level of care Intubated COVID 19.",Not Reported,,Not Reported,Yes,11.0,Not Reported,U,01/22/2021,01/25/2021,3.0,PUB,,,"1)Psoriatic arthritis - 2)Autoimmune vasculitis - Necrotizing vasculitis c.w. MPA; ANCA- 3)Mononeuritis multiplex - 4)Low back pain - spondylolisthesis L4-5; DDD @ L5-S1; spinal stenosis-lumbar 5)Benign essential hypertension - 6)Impaired fasting glycaemia - 7)Sensorineural hearing loss, bilateral - 3-8 kHz/mild -QUALIFIERS: Severity Mild to moderate 8)Polyp of colon - Colonoscopy due 2020 9)Coronary arteriosclerosis - CAD. DES stent 2013 10)Benign prostatic hypertrophy with outflow obstruction - 11)Impotence - 12)Osteoarthritis of knee, Bilateral - Moderate to advance varus gonarthrosis 13)External hemorrhoids - 14)*Prediabetes",,,"['COVID-19', 'COVID-19 pneumonia', 'Chills', 'Cough', 'Dyspnoea', 'Endotracheal intubation', 'Hypoxia', 'Pyrexia', 'Respiratory failure', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1020018,NY,74.0,M,Patient reported to be unresponsive on the morning after receiving his second dose of Moderna COVID-19 vaccine. Patient had expired during the night.,Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/09/2021,1.0,PUB,unknown,unknown,unknown,,unknown,"['Death', 'Unresponsive to stimuli']",2,MODERNA,IM 1020046,TX,37.0,F,Started with flu like symptoms with headache that would not go away after several days ended up in hospital to have lumbar puncture to relieve pressure. Had increased intracranial fluid pressure,Not Reported,,Yes,Yes,3.0,Not Reported,N,01/22/2021,01/23/2021,1.0,PVT,Wellbutrin,"Initial dose caused fatigue, muscle soreness, and joint pain that subsided after 3 days",,,Morphine,"['CSF pressure increased', 'Computerised tomogram', 'Headache', 'Influenza like illness', 'Laboratory test', 'Magnetic resonance imaging', 'Ophthalmological examination', 'Reduction of increased intracranial pressure', 'Visual field tests']",2,MODERNA,IM 1020051,OR,41.0,F,"ramsay hunt syndrome appeared day 27/28 after first vaccine, which was also the evening of dose #2",Not Reported,,Not Reported,Not Reported,,Yes,N,02/06/2021,02/06/2021,0.0,PUB,"i got second covid shot on 2/6, exactly 28 days after my first shot. by that night, i had a shingles outbreak of the rare Ramsay Hunt variety, though i DO believe it had been triggered already by the prior day. (aka 26 or 27 days after my",none,Lyme Disease since July 2005,,"whey, oat, grasses and pollens",['Herpes zoster oticus'],2,MODERNA,SYR 1020077,KY,59.0,M,"Stroke symptoms. Complete loss of function of left side of body, slurred speech, confusion. Outside of window for treatment. Partially resolved. Still having some trouble with speech, left hand still ""tingly."" Able to walk now.",Not Reported,,Yes,Yes,3.0,Not Reported,N,02/01/2021,02/05/2021,4.0,PUB,None,None,Arthritis,,Beef (Alpha Gal),"['Confusional state', 'Dysarthria', 'Gait inability', 'Hemiplegia', 'Neurological symptom', 'Paraesthesia', 'Speech disorder']",2,MODERNA,IM 1020079,OH,71.0,M,"Received Moderna covid vaccination 1/14/2021. 1/16/2021 received report of cough and difficulty breathing. Proceeded to hospital and was diagnosed Covid+ on testing. Continued to decline, died 1/31/2021.",Yes,01/31/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/31/2021,17.0,PVT,"Symbicort, sotalol, mexilitine, tiotropium, carbidopa/levodopa, aripiprazole, allopurinol, citalopram, insulin, pantoprazole, pravastatin, tamsulosin, tioptropium, warfarin, bumetanide, bupropion",,"Ischemic Cardiomyopathy, Coronary Artery Disease (MI x2 1989 and 1995), VT (ablation 2009) with Boston Scientific ICD Sick Sinus Syndrome (PPM), Type 2 Diabetes, Chronic Kidney Disease, Hypertension, Hyperlipidemia Peripheral Vascular Disease, Parkinson's Disease Antiphospholipid Antibody Syndrome Heparin Induced Thrombocytopenia",,Heparin Atorvastatin,"['COVID-19', 'Cough', 'Death', 'Dyspnoea', 'General physical health deterioration', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1020112,CA,28.0,M,Chest pain and shortness of breath. working diagnosis: pleuritis has history of mild COVID infection: diagnosed with COVID via PCR on 12/12/2020 and recovered. Hospitalized at Medical Center from 02/8/2021 to 02/09/2021.,Not Reported,,Not Reported,Yes,,Not Reported,N,02/06/2021,02/08/2021,2.0,PVT,,,,,,"['Chest X-ray normal', 'Chest pain', 'Dyspnoea', 'Echocardiogram', 'Echocardiogram normal', 'Electrocardiogram T wave inversion', 'Fibrin D dimer normal', 'Full blood count normal', 'Metabolic function test normal', 'Pleurisy', 'Red blood cell sedimentation rate normal', 'Troponin normal', 'Ultrasound Doppler', 'Ultrasound Doppler normal']",2,PFIZER\BIONTECH,IM 1020119,MI,70.0,F,My mother died suddenly on February 3rd. She went into shock/cardiac arrest and appeared to have internal bleeding. No autopsy has been performed. Unsure if it was related to the COVID vaccine.,Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,01/18/2021,02/03/2021,16.0,UNK,Unknown,Unknown,Chronic lukemia,,None,"['Cardiac arrest', 'Internal haemorrhage', 'Shock', 'Sudden death']",7+,PFIZER\BIONTECH,UN 1020161,ND,75.0,F,"Cellulitis; A spontaneous report was received from a 75-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed cellulitis. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine, clopidogrel, rosuvastatin, vitamin D, and zinc. On 14 Jan 2021, approximately one week prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient developed cellulitis. On 24 Jan 2021, the patient was seen in urgent care and given antibiotics for the cellulitis infection. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, cellulitis, was unknown.; Reporter's Comments: This spontaneous report concerns a 75-year-old female patient on blood thinners who experienced a serious event of cellulitis approximately 1 week after the administration of the first dose of the mRNA-1273 vaccine (Lot #: 041L20A, expiration date-Unknown). Treatment given include an unspecified antibiotic, and outcome is unknown. Based on the information provided, which includes a temporal association between the reported event and the administration of mRNA-1273 vaccine, a causal association cannot be excluded. Causality is confounded by the patient's advanced age.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/21/2021,7.0,UNK,LEVOTHYROXINE; CLOPIDOGREL; CRESTOR; VITAMIN D [VITAMIN D NOS]; ZINC,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Cellulitis'],1,MODERNA,OT 1020162,CA,,F,"Anaphylactic reaction; Massive bloody diarrhea; One large vomitus; A spontaneous report was received from a physician who was also a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced massive bloody diarrhea, anaphylactic reaction and one large vomitus. The patient's medical history included hives. No relevant concomitant medications were reported. On 11 Jan 2021 at 1 p.m., prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 027L20A) intramuscularly or subcutaneously in the left deltoid for prophylaxis of COVID-19 infection. On 11 Jan 2021, the event began 9 hours later with massive bloody diarrhea from 11 p.m. to 3 p.m. and one large vomitus. On 12 Jan 2021, the patient experienced hives at 3 a.m. She woke up again because of the hives at 6:30 a.m. Within 15 minutes, hives were all over the place and spread very quickly everywhere but her face. Hives were the worst in the palm of her hands. Treatment included diphenhydramine. Thirty minutes later, she woke up with a beefy red and fat tongue that felt huge and wouldn't fit in roof of her mouth. The patient found it hard to talk and swallow, and her speech was funny. The patient went to the emergency room (ER). At the ER, treatment included intravenous (IV) solumedrol, IV diphenhydramine, IV famotidine, and IV fluids. She reported that it took approximately 2-3 hours for her tongue to feel the right size, and she stayed in the ER for approximately 4 hours. At home, after seeing her primary care physician, she began taking diphenhydramine, famotidine, oral methylprednisolone, and fexofenadine. On an undisclosed date, the patient saw an allergist/ immunologist who did bloodwork and an intradermal test for polysorbate; all three times tested was negative. The allergist also did a skin prick test for polyethylene glycol (PEG) allergy, and there was a reaction at full concentration. On an undisclosed date, the patient's complement level was normal, and her tryptase was elevated which indicated acute inflammatory. Immunoglobulin E level was normal. White blood cell count was 19,000 with no left shift; 48 hours later white blood cell count was 16,000; her physician thought it was due to steroids and stress of a reaction. On 15 Jan 2021, a COVID antibody test was negative. Complement level was normal, and tryptase was elevated, which indicated acute inflammatory. White blood cell count was 19,000 with no left shift. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the event, anaphylactic reaction, was not provided. The outcome for the event, massive bloody diarrhea, was considered resolved on 12 Jan 2021. The outcome for the event, one large vomitus, was considered resolved on 11 Jan 2021.; Reporter's Comments: This spontaneous report concerns a female patient with medical history of hives, who experienced serious events of massive bloody diarrhea and anaphylactic reaction and non-serious event of one large vomitus. The events occurred on the same day after the first dose of mRNA-1273 vaccine (Lot Number: 027L20A, expiration date: unknown). Skin prick test for polyethylene glycol (PEG) showed reaction at full concentration. Treatment included solumedrol, diphenhydramine, famotidine, methylprednisolone and fexofenadine and outcome is resolved. Based on the information provided which include tempral association and evidence of reaction to a constituent of the mRNA-1273 vaccine, Ac causal association between the events and the vaccine administration cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Hives,,,"['Anaphylactic reaction', 'Blood immunoglobulin E normal', 'Complement factor normal', 'Diarrhoea haemorrhagic', 'Dysphagia', 'Inflammation', 'SARS-CoV-2 antibody test negative', 'Skin test negative', 'Skin test positive', 'Speech disorder', 'Stress', 'Swollen tongue', 'Tongue erythema', 'Tryptase increased', 'Urticaria', 'Vomiting', 'White blood cell count increased']",1,MODERNA, 1020182,PA,72.0,M,"Patient presented with sharp right lower quadrant abdominal pain with associated nausea and emesis beginning the day he received the COVID vaccine, after vaccine injection. He had decreased appetite and pain was made worse by eating. He presented to the hospital 3 days (2/6/21) after receiving the vaccine/symptom onset. His vital signs were T 101.5, HR 78, BP 156/67, RR 20, SpO2 94 on RA. As discussed below, imaging showed acalculous cholecysitis. The day after presentation, pain was more localized to RUQ. He was treated with IV ceftriaxone and flagyl. He underwent percutaneous cholecystomy tube place on 2/7/21 with plan for delayed cholecystectomy following drain placement x 6 weeks. Bile fluid culture has been no growth. We are attempting to test bile fluid for COVID-19 via PCR. He tested positive for COVID-19 via nasal swab RT-PCR and developed a 3L oxygen requirement and mild dyspnea. He was treated with remdesivir and dexamathasone 2/6-2/10 with resolution of hypoxia and dyspnea.",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,02/03/2020,02/06/2021,369.0,PVT,atorvaSTATin 20 MG tablet Take 20 mg by mouth daily. enalapril 5 MG tablet Take 4 tablets by mouth every 12 hours. glipiZIDE 10 MG tablet Take 20 mg by mouth daily. metFORMIN 500 mg tablet Take 1 tablet by mouth 2 times a day with meals.,None,"Hypertension, diabetes, prior unknown abdominal surgery",,Aspirin,"['Abdominal pain lower', 'Abdominal pain upper', 'Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Bile culture negative', 'Biliary catheter insertion', 'Blood alkaline phosphatase increased', 'Blood bilirubin normal', 'Blood creatinine increased', 'Blood culture negative', 'Blood glucose increased', 'COVID-19', 'Cholecystitis', 'Cholecystitis acute', 'Computerised tomogram abnormal', 'Decreased appetite', 'Dyspnoea', 'Haemoglobin decreased', 'Hypoxia', 'Influenza virus test negative', 'Lipase normal', 'Nausea', 'Pneumonia bacterial', 'SARS-CoV-2 test positive', 'Vomiting', 'White blood cell count normal']",1,MODERNA, 1020183,FL,66.0,F,Death. I actually not sure which Covid Vaccine she took. I just know the date and time she took it at her local school where she worked. Died in her sleep after complaining of a headache. I talked to her around 5pm on sunday through a videochat and she seemed happy and well. But a local friend commented that she had complained of a headache late in the afternoon.,Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/07/2021,5.0,SCH,Unknown,Unknown,Angina,,Unknown,"['Death', 'Headache']",UNK,PFIZER\BIONTECH, 1020195,OH,81.0,M,"Received Moderna #1 on 1/12/2021. 1/15/2021 developed worsening shortness of breath. Went to hospital and diagnosed with anemia, 4 negative fecal tests, neg EGD and colonoscopy. Discharged and readmitted (circumstances unknown for this episode) then readmitted a third time 1/20/2021 for shortness of breath. Diagnosed covid + at third hospitalization and continued to get worse. He died 1/23/2021.",Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/15/2021,3.0,PVT,"Allopurinol, amlodipine, Atorvastatin, carvedilol, ipratropium, asa",None,"HTN, Osteoarthritis, brain aneurysm",,None,"['Anaemia', 'COVID-19', 'Colonoscopy normal', 'Condition aggravated', 'Death', 'Dyspnoea', 'Occult blood negative', 'Oesophagogastroduodenoscopy normal']",UNK,MODERNA,IM 1020227,NM,96.0,M,"This is the patient who passed away 2d after his second COVID vaccine. Of note, the 2/8 telephone note makes it sound like he was hospitalized at time of death - that is incorrect. His daugther listed as EM contact works in the eye clinic here. He had mild illness, completed 10d isolation but missed his scheduled booster dose on 2/2 due to isolation. He was called on 2/5 when there was a booster visit cancellation and received his booster dose on that day. His daugther reported that he was doing fine and looking well on 2/7 AM, ate breakfast, shortly after stood up and just collapsed.",Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/07/2021,2.0,PVT,ALENDRONATE SODIUM 70MG TABLET (4'S) TAKE ONE (1) TABLET ACTIVE BY MOUTH ONE TIME EACH WEEK WITH WATER 30 MINUTES BEFORE EATING OR TAKING OTHER MEDICATIONS CALCIUM W/ VITAMIN D 600/500 SLOW RELEASE TAKE 2 TABLETS ACTIVE BY MOUT,"Pt had COVID with symptom onset 1/27/21, pos test 1/28/21 admitted to Hosptial and was treated w/ remdesivir at , discharged 1/30 on Dexamethasone 6mg daily, no need for O2 supplement. First moderna COVID vaccine was 1/5/21.","1)*AU SEVERE LOSS 2)Anemia - 3)Tubular adenoma of colon - 4)*SCLERAL PLAQUE EXCISION OS - STILL PO 2+ MONTH 5)Osteoarthritis - bilateral knees...worse in right knee -QUALIFIERS: Severity Moderate to severe 6)Chronic obstructive lung disease - 7)Onychomycosis - x10 -QUALIFIERS: Severity Mild to moderate Clinical course Chronic 8)Artificial lens present - OU 9)Hypermetropia - OD 10)Presbyopia - OU 11)Regular astigmatism - OD 12)Arcus of cornea - OU 13)Scarred macula - OS 14)Osteoporosis - 15)Osteoarthritis of knee - 16)Hypothyroidism - 17)Benign prostatic hyperplasia - 18)Hip pain, Right - Had right hip fracture pinning and has post traumatic DJD 19)Chronic pain - 20)Dry eyes - 21)Sensorineural hearing loss, Bilateral - 22)Nonexudative age-related macular degeneration, Bilateral -",,Allergies: CODEINE,"['Death', 'Illness', 'Patient isolation', 'Syncope']",2,MODERNA,IM 1020280,NM,32.0,M,"Pt is a 33 y/o male who presents to the ED with c/o of left le swelling progressing over the last 4 days. Pt has no other c/o. Denies fever, cough, cp, abd pain, n/v/d. Pt has had his first COVID vaccine 1/30. Patient was noted to be tachycardic to the 120's in the ER, after 1L of normal saline still tachycardic to the 110's. Lower extremity doppler was negative for DVT, however PE protocol CTA of the chest was positive for a PE, report follows. Patient was given lovenox and flown to Medical Center for higher level of care.",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/30/2021,02/04/2021,5.0,PVT,FUROSEMIDE 20MG TABLET TAKE ONE (1) TABLET BY MOUTH EVERY ACTIVE MORNING FOR EXCESS FLUID LIDOCAINE 5% PATCH APPLY 1 PATCH TO CLEAN NON-HAIRY AREA ACTIVE ON SKIN DAILY *LEAVE ON FOR 12 HOURS AND THEN REMOVE FOR 12 HOURS* LISINOPR,12/22/20 was in Emergency room for a viral URI with a negative COVID test.,1)Nephrotic syndrome - 2)Proteinuria - 3) Pre DM 4) Obesity,,No known drug allergies,"['Activated partial thromboplastin time normal', 'Angiogram pulmonary abnormal', 'Anion gap normal', 'Ascites', 'Basophil count decreased', 'Basophil percentage', 'Blood albumin decreased', 'Blood alkaline phosphatase increased', 'Blood bilirubin decreased', 'Blood calcium decreased', 'Blood chloride increased', 'Blood creatine normal', 'Blood glucose normal', 'Blood immunoglobulin G', 'Blood potassium normal', 'Blood sodium normal', 'Blood test', 'Blood urea normal', 'Carbon dioxide normal', 'Cholelithiasis', 'Computerised tomogram thorax abnormal', 'Differential white blood cell count normal', 'Eosinophil percentage', 'Haematocrit normal', 'Haemoglobin normal', 'Influenza A virus test negative', 'International normalised ratio normal', 'Lymphocyte count abnormal', 'Lymphocyte percentage', 'Mean cell haemoglobin', 'Mean cell haemoglobin concentration', 'Mean cell haemoglobin decreased', 'Mean cell volume abnormal', 'Mean platelet volume normal', 'Monocyte count decreased', 'Monocyte percentage', 'Neutrophil count normal', 'Neutrophil percentage', 'Peripheral swelling', 'Platelet count normal', 'Protein total decreased', 'Prothrombin time shortened', 'Pulmonary embolism', 'Red blood cell count increased', 'Red cell distribution width increased', 'Respiratory syncytial virus test negative', 'SARS-CoV-2 test negative', 'Tachycardia', 'Ultrasound Doppler', 'Ultrasound Doppler normal', 'White blood cell count normal']",1,PFIZER\BIONTECH,IM 1020284,MN,91.0,M,"DIAGNOSIS: #1. CVA #2. Aphasia, acute Number 3. Change in mental status, acute ASSESSMENT/PLAN/DECISION MAKING: Spoke with radiologist informed me that patient had a deep ischemic or infarct change in his corona radiata area which is common in patients with covid 19 infection or vaccination, which patient had a day and a half ago after lengthy discussion with wife, she informed me that patient would not want CPR and he had a stroke in the past and does not want to go to another city as he is 91 years old and therefore not a candidate for thrombolysis and also this was a wakeup stroke and so we do not know his exact time of onset, and she states that they simply want to be treated here for comfort care.",Not Reported,,Not Reported,Yes,11.0,Not Reported,U,01/28/2021,01/30/2021,2.0,PUB,,none,"parkinonsim, hypertension, hyperlipidemia, hear loss, renal stones, alzheimers.",,NKA,"['Aphasia', 'Cerebrovascular accident', 'Chest X-ray', 'Computerised tomogram head', 'Full blood count', 'International normalised ratio', 'Mental status changes', 'Metabolic function test', 'Prothrombin time', 'Troponin I']",1,PFIZER\BIONTECH,SYR 1020298,NY,73.0,F,"Patient arrived to ED via ambulance a few days after first COVID-19 vaccine (manufacturer unknown). First COVID shot on Friday, has been experiencing myalgias , weakness, fevers and chills Has been drinking water to try and stay hydrated She has been laying around because she has not been feeling well She tried to get up to answer phone, had dizzy spell and fell forward and hit her right side of head on table. No LOC Now head, neck, low back pain Patient ambulated on her own",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/22/2021,01/25/2021,3.0,UNK,"acetaminophen (TYLENOL) 500 MG tablet Take 2 tablets (1,000 mg total) by mouth 3 (three) times a day Qty: 50 tablet, Refills: 1 � Adalimumab (HUMIRA) 40 MG/0.4ML PSKT Inject 40 mg under the skin every 14 (fourteen) days � amLODIPine (NORVA","UTI, prerenal AKI","Anxiety � ? Coronary artery disease � � Followed by Dr. ? CVA (cerebral infarction) � � 2002 left sided weakness, ? Depression � ? Diabetes mellitus � ? Diabetes mellitus, type 2 � ? GERD (gastroesophageal reflux disease) � ? High cholesterol � ? History of transfusion � � 1990's ? Hypertension � ? IDA (iron deficiency anemia) � � follows with Dr. ? Lupus � ? Mixed incontinence � ? Osteoarthritis � ? Polymyalgia rheumatica � � Followed by Dr. ? Pseudoaneurysm � ? Rheumatoid arthritis � ? Sleep apnea � � BIPAP ? Sleep apnea � ? Stroke � �",,Allergies:Cortisone; Novocain [procaine]; and Lasix [furosemide],"['Acute kidney injury', 'Asthenia', 'Back pain', 'Bacterial test positive', 'Chills', 'Computerised tomogram head normal', 'Computerised tomogram spine', 'Dizziness', 'Fall', 'Head injury', 'Headache', 'Malaise', 'Myalgia', 'Neck pain', 'Pyrexia', 'Urine leukocyte esterase positive', 'White blood cells urine positive']",1,MODERNA, 1020320,IA,48.0,M,"After the first vaccine next day at 9:00am I have shooting headache,severe pounding in my ear. I told my wife (physician) what happened she recommended me to go toER. I went to ER they thought I had a stroke,CT scan diagnosed with subarachnoid bleeding. I was transferred to another hospital 1 day had another CT scan, MRI Scan and was seen by a Neurosurgeon. I was told I have a revolving bleeding in my brain, loss sensation right side and double vision. I'm scheduled for Cerebral Angiogram in Feb.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,No,No,No,,No,"['Cerebral haemorrhage', 'Computerised tomogram head abnormal', 'Diplopia', 'Ear pain', 'Headache', 'Magnetic resonance imaging brain abnormal', 'Sensory loss', 'Subarachnoid haemorrhage']",1,MODERNA,IM 1020333,CA,91.0,F,"Had swelling in leg for a couple of days prior to the early morning of 1/31 where the knee and entire lower leg was swollen and painful and made it very painful to walk. After sending photo to primary care physician had mom evaluated for a blood clot. It was determined based on blood test, vascular ultrasound that right non occlusive (mid) Femoral vein DVT.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/22/2021,01/31/2021,9.0,PVT,Cymbalta (30 mg every other day for past pinched nerve pain - weaning off ),,arthritis,,penicillin,"['Deep vein thrombosis', 'Fibrin D dimer', 'Pain in extremity', 'Peripheral swelling', 'Thrombosis']",1,PFIZER\BIONTECH,SYR 1020397,CA,80.0,M,"Dizziness, jaundice secondary to acute hemolytic anemia, COVID-19 POSITIVE",Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/31/2021,02/02/2021,2.0,OTH,"Amlodipine, Tamsulosin, Enzalutamide, Lupron",None.,"HTN, Prostate cancer, Prostatic Hyperplasia",,None known.,"['Blood bilirubin increased', 'Blood folate', 'COVID-19', 'Dizziness', 'Haemoglobin decreased', 'Haemolytic anaemia', 'Jaundice', 'SARS-CoV-2 test positive']",1,MODERNA,SYR 1020399,MO,65.0,M,"Patient had vaccine on 1/29/21 and had STEMI on 2/4/21, started with back pain symptoms on 1/31/21 requiring hospitalization and MI occurred in the hospital",Not Reported,,Yes,Yes,4.0,Not Reported,Y,01/29/2021,02/04/2021,6.0,UNK,"aspirin, plavix, tresiba, gabapentin, jardiance, trulicity, metformin, prilosec, wellbutrin, atorvastatin, metoprolol, spironolactone, losartan, lovaza",,"Coronary artery disease, hyperlipidemia, type 2 diabetes, GERD, HTN, mood disorder, cervical spinal stenosis",,"Ace inhibitors, amoxicillin","['Acute myocardial infarction', 'Back pain', 'Catheterisation cardiac abnormal', 'Condition aggravated', 'Coronary artery stenosis', 'Myocardial infarction']",UNK,PFIZER\BIONTECH, 1020437,GA,65.0,M,Patient is bedbound at home after multiple strokes. He also has dysarthria at baselin. Was in usual state of health. Received vaccine at medical facility on 1/29/21. Caregiver reported that he subsequently had behavioral change the following day and stopped oral nutrition intake. He was subsequently admitted to Hospital on 2/6/2021 with encephalopathy and severe dehydration.,Not Reported,,Not Reported,Yes,4.0,Not Reported,U,01/29/2021,01/30/2021,1.0,PVT,"amlodipine, pantoprazole, metoprolol, lisinopril, clopidogrel, atorvastatin, glipizide, mirtazapine aspirin, tylenol",None acute,History of multiple CVA 8/2011 and 6/2019 resulting on left sided paralysis and dysarthria. Bedbound. Hypertension. CAD with stent to LAD (2018). CKD.,,None,"['Abnormal behaviour', 'Dehydration', 'Encephalopathy', 'Hypophagia', 'Imaging procedure', 'Laboratory test']",1,PFIZER\BIONTECH, 1020443,AZ,73.0,M,"For the two days prior to presentation the patient had been complaining of chest pain, his breathing seemed to be labored Monday. He and the family thought the pain was due to shingles as he carried this diagnosis from a month ago. Patient had also received the COVID vaccine 2 days prior to presentation and assumed he was feeling unwell due to the vaccine. Family wanted to take him to the hospital yesterday and earlier today but he refused. She left him in his home earlier this afternoon prior to presentation and returned to check on him finding him unresponsive and apneic at which time EMS was activated. #cardiac arrest -- suspect primary cardiac given collateral from family at home, consider hypoxemia which was corrected with advanced airway and 100% FiO2, patient clinically euvolemic and with soft brown stool in diaper not suggestive of GI hemorrhage, attempt to address acidosis with CPR and bicarbonate, not hypoglycemia, on bedside ultrasound FAST neg and no pericardial effusion suggestive of tamponade and +lung sliding bil not spontaneous pneumothorax Assessment/Diagnosis: -cardiac arrest, cause unspecified",Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/03/2021,4.0,PVT,Unknown,"Unknown, per patient's daughter patient had unevaluated chest pain for 2 days prior to presentation",Unknown,,No known drug allergies,"['Acidosis', 'Apnoea', 'Cardiac arrest', 'Chest pain', 'Dyspnoea', 'Endotracheal intubation', 'Hypoxia', 'Malaise', 'Resuscitation', 'Ultrasound abdomen', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 1020449,CA,92.0,F,"melena, severe anemia, gi bleed and severe thrombocytopenia",Not Reported,,Yes,Yes,,Not Reported,U,01/26/2021,02/08/2021,13.0,UNK,"combigan, Colace, ferrous sulfate, xalatan, and Tylenol as needed",none,"glaucoma, arthritis",,none,"['Anaemia', 'Gastrointestinal haemorrhage', 'Haemoglobin decreased', 'Melaena', 'Platelet count decreased', 'Thrombocytopenia']",UNK,PFIZER\BIONTECH, 1020485,ME,59.0,F,"2/5 my head behind my left ear hurt, I looked fatigued to others, in the evening my tongue seemed swollen, On 2/6, my taste was off and left eye started running, my lips felt swollen. On 2/7 I woke up to not being able to close my left eye and lift my left lips. Immediately contacted my PPC who did an exam and determined it was Bell's Palsy. Was started on Predisone and antiviral medication immediately",Not Reported,,Not Reported,Not Reported,,Yes,N,01/01/2021,02/05/2021,35.0,PVT,Levothyroxin 112 MCG ; Estradiol 2mg; Lisinopril 10 mg,none,none,,no,"['Eye discharge', 'Eyelid function disorder', 'Facial paralysis', 'Facial paresis', 'Fatigue', 'Headache', 'Lacrimation increased', 'Lip disorder', 'Lip swelling', 'Swollen tongue', 'Taste disorder']",2,MODERNA,IM 1020517,PA,60.0,F,"Five days following the first dose of the Moderna COVID-19 vaccine, the patient developed diffuse body pain, beginning in the right shoulder (for which she received a steroid injection), but then spreading to the entire body. This pain became so severe that she presented to the hospital via EMS, and was found to have a platelet count of 41 (9 days following the vaccine). No baseline platelet count is available prior to the vaccine (most recent was from 2019). Immune-mediated thrombocytopenia is being considered, and the patient has been placed on IVIG and steroids. It is now 4 days into the patient's admission, and platelets continue to fall (currently 26). Hemoglobin appears normal at the time and there is no sign of active bleeding. Of note, the patient also has positive blood cultures, so thrombocytopenia as a result of sepsis is also a possibility.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/30/2021,02/07/2021,8.0,UNK,"Gabapentin, glimepiride, insulin, liraglutide, lisinopril, metformin, tramadol","Right shoulder pain (attributed to ""sleeping on it wrong""), which progressed into diffuse body pain for which the patient was admitted before discovering the adverse event being reported","Psoriasis, diabetes mellitus, hypertension",,Sulfonamide antibiotics,"['Blood culture positive', 'Blood smear test normal', 'Immunoglobulin therapy', 'Injection site pain', 'Pain', 'Platelet count decreased']",1,MODERNA,IM 1020627,IN,72.0,M,"Started with numbness on right side of face on 2/3/21. Numbness continued and subsequently went to ER, at approximately 10:30 AM. After receiving an EKG, a chest X-Ray, and a CT of the head, I was informed that I had developed Bell's Palsy. I was then seen by Dr., Neurology who also confirmed. I was then admitted to the hospital for observation and another CT of the head 24 hours after the first. I was given Acyclovir 200mg and Prednisone 10mg. during my hospital stay and prescribed after discharge at approximately 5 PM on 2/5/21. as of the date of this report, still experiencing same symptoms",Not Reported,,Not Reported,Yes,1.0,Yes,N,01/21/2021,02/03/2021,13.0,OTH,Carvedilol; Eliquis; Pantoprazole; Lisinopril; doxazosin; Tamsulosin; Atorvastatin; Amiodarone; Finasteride: Furosimide,None,Heart; Back,2009 Flu Vaccine. developed Nerve Damage in Left Arm,Thallium; Flu Vaccine,"['Blood test', 'Chest X-ray', 'Computerised tomogram head normal', 'Electrocardiogram', 'Facial paralysis', 'Hypoaesthesia']",1,MODERNA,SYR 1020651,WI,90.0,F,Patient admitted to hospital with diagnosis of heart failure exacerbation.,Not Reported,,Not Reported,Yes,,Not Reported,N,02/09/2021,02/10/2021,1.0,UNK,"allopurinol, aspirin, carvedilol, vitamin D, Plavix, doxazosin, hydralazine, potassium, protonix, magnesium oxide, torsemide Colace",unknown,"lymphedema, heart failure, anemia, AAA s/p endovascular repair, renal artery stenosis, gout, GERD< HTN, CAD, h/o cerebral infarct",,"Statins, Bactrim","['Cardiac failure', 'Condition aggravated']",1,MODERNA, 1020654,ME,65.0,F,Patient found unresponsive in room with no pulse or respirations. She was pronounced dead by paramedics at 06:25am on 2/5/2021.,Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,SEN,"Xarelto, Verapamil ER, Amlodipine, Durezol, Trelegy Ellipta, Gabapentin, Oxycodone, Sertraline, Carafate, Trazadone, Atorvastatin, Calcium and Vit. D, Vit. D 25mcg, Vit. B-12, Famotadine, Ferrous Sulfate, Metoprolol Succinate XR, Pantoprazo","Acute Onchronic Respiratory Failure, Aspiration Pneumonia, and NSTEMI, Diarrhea, Hypertrophic cardiomyopathy, Gram positive bacteremia, Acute kidney injury, Afib,","COPD, Non-small cell lung cancer, CAD, Rheumatoid Arthritis, Chronic Normocytic Anemia, GERD, HTN, Hypokalmia, Aneurysm of the thoracic aorta,",,NKA,"['Death', 'Pulse absent', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 1020664,KS,46.0,M,"Per patient, woke up on the morning after the day following his vaccination (2/9/21) with chest pain, shortness of breath, and feeling light-headed. He tried to sit up, saw red dots, and ""passed out"" momentarily. He had severe headache upon awakening, ringing in ears, and blurry vision. Went back to bed and slept all day. Symptoms worsened every time he tried to get up. Woke up this AM, with symptoms persisting. Came in for OV, BP noted to be elevated at 150/106. Patient was sent to hospital via ambulance for further work-up and management.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/08/2021,02/09/2021,1.0,PUB,none,,"hyperlipidemia, GERD, hypertension",,"flexeril, ibuprofen, methadone, simvastatin","['Blood pressure increased', 'Chest pain', 'Dizziness', 'Dyspnoea', 'Dysstasia', 'Headache', 'Loss of consciousness', 'Somnolence', 'Tinnitus', 'Vision blurred', 'Visual impairment']",2,MODERNA,IM 1020671,AK,41.0,F,"41 year old female received Moderna vaccine on 1/8/2021 (lot 011J20A) and 2/4/2021(lot 011 L20A) . About 2 days post vaccination noted small red spots on her tongue, arms and legs. On 6 days post vaccination she noticed a red mark on her neck and had prolonged epistaxis. She had a normal hemocue in the clinic and normal vital signs with no further bleeding. She was sent to the Emergency Department via chartered flight. In the ED she was noted to have a petechial rash of mucous membranes, upper and lower extremities and multiple ecchymosis. Her platelet count was 2. Hemoglobin 13.3, hematocrit 40.2%, WBC 7.86. Metabolic panel unremarkable, coagulation studies unremarkable. Vital signs normal. After consultation with hematology, Dr., she was given high dose steroids and tranexamic acid and sent via medevac to MC for possible IV Ig and platelet transfusion. She arrived there sometime early this morning. Platelets were 4 upon arrival at Medical Center.",Not Reported,,Yes,Yes,,Not Reported,U,02/04/2021,02/06/2021,2.0,PVT,Vitamin D,None,Psoriasis,,Septra and erythromycin ointment,"['Coagulation test normal', 'Ecchymosis', 'Epistaxis', 'Erythema', 'Haematocrit normal', 'Haemoglobin normal', 'Metabolic function test normal', 'Mouth haemorrhage', 'Petechiae', 'Platelet count decreased', 'Tongue erythema', 'White blood cell count normal']",2,MODERNA,IM 1020684,MI,73.0,M,"Patient received vaccine at Public Health Clinic. Patient ended up having a seizure 3 days later and ended up in the hospital. Found to have right lobe pneumonia and low depakote level. Patient noted to have multiple seizures at hospital, issues with stabilizing HR and BP, and passed away on 1/20/21.",Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,,01/13/2021,01/16/2021,3.0,PUB,,,history of seizure disorder,,,"['Anticonvulsant drug level decreased', 'Blood pressure abnormal', 'Death', 'Heart rate abnormal', 'Pneumonia', 'Seizure']",1,MODERNA,IM 1020702,VA,45.0,F,Passed away the morning of 2/9/21.,Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,01/20/2021,02/09/2021,20.0,PVT,"Hydrochlorothiazide, Hydroxyzine, Mirena, Ocrevus, Prednisone, triamcinolone acetonide, valacyclovir, vitamin D 3",,calcaneal spur displacement of intervertebral disc without myelopathy female stress incontinence foot pain hand joint pain herpes simplex low back pain menorrhagia multiple sclerosis neck pain numbness of lower limb peripheral edema polyneuropathy,,No known allergies.,['Death'],1,MODERNA,IM 1020708,MD,25.0,F,"Patient developed rapid onset of dyspnea, light headedness and tachycardia. Was taken to the ED where she was treated with an antihistamine and IV fluids. Symptoms resolved. 6 days after the vaccine, was having shortness of breath and left arm pain (not the arm where injection was received) and was diagnosed with a pulmonary embolism.",Not Reported,,Not Reported,Yes,2.0,Not Reported,,01/22/2021,01/22/2021,0.0,PVT,,,Mast Cell Activation Disorder POTS,,,"['Dizziness', 'Dyspnoea', 'Pain in extremity', 'Pulmonary embolism', 'Tachycardia']",1,PFIZER\BIONTECH,SYR 1020716,OK,92.0,F,About 12 minutes after the vaccine she developed chest pain and left arm pain.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/09/2021,02/09/2021,0.0,PVT,,,,,,"['Chest pain', 'Pain in extremity']",1,MODERNA,SYR 1020724,AL,82.0,M,"Patient sent to the ED or sudden onset of shortness of breath on 02/02/2021. Per documentation by the MD, the patient had COVID19 ""several weeks ago"" and the nursing facility felt like he had recovered. A rapid test done in the ED was negative. When the patient worsened and seemed to be following the same path as other COVID patients, a send out PCR test was done, which was positive. The patient worsened and passed away that same day (02/05/2021) I was not made aware that the patient had the vaccine on 01/21/2021 until Monday 02/08/2021.",Yes,02/05/2021,Not Reported,Yes,4.0,Not Reported,N,01/21/2021,02/02/2021,12.0,SEN,,"COVID19,",hypertension and Coronary Artery Disease,,"codeine, penicillin","['COVID-19', 'Condition aggravated', 'Death', 'Dyspnoea', 'SARS-CoV-2 test positive']",UNK,MODERNA, 1020727,NH,49.0,M,"02/03-02/04/2021 TEMPERATURE 100.5 *F, TREATMENT WITH TYLENOL. 02/05/2021 FELT WORSE IN THE MORNING, TREATMENT WITH ALEVE, FELT BETTER. EVENING BEGAN TO HAVE CHEST PAIN, BODYACHE, NECK/JAW PAIN - WENT TO EMERGENCY ROOM. CARDIAC LABS ELEVATED ADMITTED TO HOSPITAL. ALL OTHER TESTS CAME BACK WITHIN LIMITS BUT CATH NOT AVAILABLE ON THE SEEKENDS SO HELD. PATIENT CATH WAS CLEAR, RELEASED APPROX 1600 02/08/2021 WITH INSTRUCTIONS TO FOLLOW-UP WITH PCM. PCM APPOINTMENT SCHEDULED FOR 02/12/2021.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,02/03/2021,02/03/2021,0.0,MIL,PRILOSEC,NONE,GERD,"Same symptoms, Smallpox vaccination, age 18yrs, Wyeth",NONE,"['Body temperature increased', 'Catheterisation cardiac normal', 'Chest pain', 'Electrocardiogram', 'Myocardial necrosis marker increased', 'Neck pain', 'Pain', 'Pain in jaw', 'Troponin increased']",2,MODERNA,IM 1020733,,80.0,F,"The night after receiving dose 1 of the vaccine, she didn't want to eat dinner, was starting to spit up saliva, and noted a new headache, and asked her daughter to sleep with her that night considering she was feeling poorly. She was restless all night, and then at ~5am her L arm began to twitch; she was still alert at this time but didn't realize her arm was moving. Shortly after this she lost consciousness, her eyes rolled back in her head, and she developed a frank GTC seizure. Her daughter called an ambulance, and by the time she was on the way to the hospital, she was awake and alert again. At the hospital, she was initially talking and able to answer most questions appropriately. She was noted to be afebrile, hemodynamically stable, without an O2 requirement, though with tachycardia to the 110s. She was found to have a leukocytosis to ~16, thrombocytosis to ~550, and LDH elevated in the 600s. Over the following day, her mental status declined and she became agitated and disoriented to place/time. CT chest revealed b/l multifocal pneumonia, for which she was started on pip-tazo. She underwent MRI brain (DWI sequence only) which did not reveal any obvious CVA. LP was performed on 1/29 at ~10PM; as far as we can tell, she had only received pip-tazo for antibiotics at this point. CSF studies revealed 220 WBCs (14% PMNs, 76% lymphs, 10% monos), 14 RBCs, Glu 59, Prot 145; GS 2+ WBCs, no orgs; india ink stain negative; Cx pending at time of transfer. Given concern for bacterial or viral meningoencephalitis she was transitioned to vancomycin/ceftriaxone/acyclovir. Patient was then transferred to another Hospital for further management. Micro was all negative or pending at the time of transfer. Shortly after admission to hospital she was intubated. Spine MRI was notable for longitudinally extensive transverse myelitis. All infectious workup has been negative with just two more pending studies for tuberculosis; autoantibody panel pending. She is now able to follow commands with eyes and mouth, but has not been able to move her arms or legs. We do not have high suspicion that this syndrome is related to the vaccine, given that progressive neurological symptoms started the week before vaccine, but thought it prudent to report given the time course.",Not Reported,,Not Reported,Yes,14.0,Not Reported,N,01/27/2021,01/28/2021,1.0,PUB,"albuterol 2mg/5 mL syrup PRN, budesonide-formoterol 160-4.5 mcg/act 2 puffs BID, candesartan HCTZ 16-12.5 mg/tab 0.5 tabs daily, ezetimibe-simvastatin 10-20 mg/tab 1 tab nightly, omeprazole 20mg","lung nodules, 6 mo wt loss/night sweats, 1 wk paresthesias. More detail on neurological symptoms preceding vaccine: 1/21/21 noted R rib pain, burning in L finger, burning in L leg; more prominent 1/23-1/24, which prompted calling a doctor - they noted she was having trouble distinguishing which leg was being touched.","COPD, hypertension, hyperlipidemia",,No known allergies.,"['Agitation', 'Autoantibody test', 'Blood lactate dehydrogenase increased', 'CSF glucose normal', 'CSF lymphocyte count normal', 'CSF monocyte count decreased', 'CSF neutrophil count increased', 'CSF protein increased', 'CSF red blood cell count positive', 'CSF white blood cell count increased', 'Culture', 'Decreased appetite', 'Disorientation', 'Dyskinesia', 'Endotracheal intubation', 'Feeling abnormal', 'Food refusal', 'Gaze palsy', 'Generalised tonic-clonic seizure', 'Gram stain positive', 'Headache', 'Leukocytosis', 'Loss of consciousness', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging spinal abnormal', 'Mental status changes', 'Microbiology test normal', 'Mobility decreased', 'Movement disorder', 'Muscle twitching', 'Mycobacterium tuberculosis complex test', 'Myelitis transverse', 'Platelet count increased', 'Pneumonia', 'Poor quality sleep', 'Restlessness', 'Salivary hypersecretion', 'Tachycardia', 'Thrombocytosis', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1020749,MS,68.0,M,"Patient had no reaction at the clinic. Patient is a medical doctor whose partner called in this death. States patient had no complaint on 1/13 nor 1/14 while at work. States patient died at home on 1/15 a.m. Physician who stated she was called to the patient's home @ 0157 1/15/2021 and found cyanotic from head to toe. State girlfriend found him sitting in the chair a few minutes before they called her. The Coroner did not order autopsy. Did not sent patient to the hospital. Sent him directly Funeral Home. Death Certificate Number 123-2021-002593 list cause of death as pending. I spoke with the patient's primary doctor who gave me the history of HTN, Diabetes, & High Cholesterol. States he had not seen this patient since April 2020. They were also friends and he was not aware of any medical problems. The Coroner state she thinks patient has a heart attack. Neither the Coroner nor PMD think death was related to COVID Vaccine. Informed both that MSDH would have to complete VAERS. Both voiced understanding.",Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/15/2021,2.0,PUB,Unknown,Unknown,"HTN, Diabetes, High Cholesterol",,Unknown,"['Cyanosis', 'Death', 'Myocardial infarction']",1,MODERNA,IM 1020750,MA,65.0,M,"Pt is s/p liver transplant in May 2012 on chronic immunosuppression medication. He received first dose of Covid vaccine on 1/29/2021. On routine labs on 2/5/2021, LFTs were significantly elevated from baseline - ALT 123 (27), AST 66 (21), Alkaline Phosphate 242 (127), Total bilirubin 2.8 (0.3), Direct bilirubin 1.9 (<0.2). He did report new full body itching the day before. As a result of elevated labs, the patient presented to the emergency room due to concerns for biliary obstruction versus graft rejection. Repeat liver function tests were still elevated, although slightly better. Abdominal US was normal, no signs of dilatation or obstruction with patent vasculature. Pt was admitted to the inpatient transplant unit overnight and labs repeated on 2/6 showed continued improvement. With this, pt was continued on the same immunosuppressive med regimen and discharged home with close outpatient transplant follow-up.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/29/2021,02/05/2021,7.0,PVT,,Melena requiring hospitalization,Hepatitis C and Hepatocellular carcinoma s/p liver transplant 5/2012 CKD Type 2 diabetes Hypertension Latent tuberculosis COPD Covid-19 ARDS in April-June 2020,,"Cefepime, Rifampin","['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Bilirubin conjugated increased', 'Blood alkaline phosphatase increased', 'Blood bilirubin increased', 'Liver function test increased', 'Pruritus', 'Ultrasound abdomen normal']",UNK,PFIZER\BIONTECH,IM 1020784,UT,89.0,F,"Paralysis swelling. Seizure, lost eye sight, partial speech ! And is bed riding and loss of balance",Not Reported,,Yes,Not Reported,,Yes,N,01/21/2021,01/23/2021,2.0,PUB,No,No,No,,Nono,"['Balance disorder', 'Bedridden', 'Blindness', 'Mobility decreased', 'Paralysis', 'Seizure', 'Speech disorder', 'Swelling']",UNK,MODERNA,SYR 1020792,IN,65.0,F,"Extreme headache, nausa,low grade fever, vomiting",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/01/2021,02/10/2021,9.0,PVT,"Bacoflen,effexor,bisohphyy",None,None,,None,"['Headache', 'Nausea', 'Pyrexia', 'Vomiting']",UNK,PFIZER\BIONTECH, 1020815,MN,85.0,F,"Initial temp of 100.4, upon recheck 101.9 with 650mg Tylenol given. IV initiated due to low blood pressure - 78/35. 400mL NS given then converted to D5 due to GFT being 55. O2 Sats 64% RA when vitals assessed and quickly climbed, ordered to apply continuous O2 at 2LPM via NC and sats climbed to 96%. Last BP 78/35, Dr. ordered for pt to be sent in to hospital if pressure doesn't come up in the next 30 minutes. Pt in trendelenberg position, responds to verbal stimuli. Denies pain. Only complaint was feeling weak. BS up to 197 after tolerating 120ml cranberry juice. Pressures continue to stay low, last BP 72/27, Discussed with Dr. with orders to send to hospital. Admitted to hospital with Hypoglycemia and Hypokalemia.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/09/2021,02/09/2021,0.0,SEN,Carvedilol Hydralizine Isosorbide Dinitrate Omeprazole Potassium Chloride Alphagan P Solution 0.1% Amlodipine Besylate Baby Aspirin Fludrocortisone Acetate Glipizide Hydrocortisone Loteprednol Etabonate Syspension 0.5% Bumetanide Tylenol M,Recovering from recent right lung pulmonary embolism and urinary tract infection with severe sepsis,"PRIMARY ADRENOCORTICAL INSUFFICIENCY TYPE 2 DIABETES MELLITUS WITH OTHER DIABETIC NEUROLOGICAL Diagnosis 6 COMPLICATION TYPE 2 DIABETES MELLITUS WITH DIABETIC CHRONIC KIDNEY DISEASE MAJOR DEPRESSIVE DISORDER, SINGLE EPISODE, UNSPECIFIED HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE WITH HEART FAILURE AND STAGE 1 THROUGH STAGE 4 CHRONIC KIDNEY DISEASE, OR UNSPECIFIED CHRONIC KIDNEY DISEASE CHRONIC DIASTOLIC (CONGESTIVE) HEART FAILURE CHRONIC KIDNEY DISEASE, STAGE 3 UNSPECIFIED HYPOTHYROIDISM, UNSPECIFIED TYPE 2 DIABETES MELLITUS WITH DIABETIC PERIPHERAL ANGIOPATHY WITHOUT GANGRENE HYPOMAGNESEMIA HYPO-OSMOLALITY AND HYPONATREMIA HYPOKALEMIA UNSPECIFIED IRIDOCYCLITIS PRIMARY OPEN-ANGLE GLAUCOMA, RIGHT EYE, SEVERE STAGE GLAUCOMA SECONDARY TO EYE INFLAMMATION, LEFT EYE, SEVERE STAGE GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS DIVERTICULOSIS OF LARGE INTESTINE WITHOUT PERFORATION OR ABSCESS WITHOUT BLEEDING POLYOSTEOARTHRITIS, UNSPECIFIED",,Nitrofurantoin Bactrim Cipro,"['Asthenia', 'Blood glucose normal', 'Body temperature increased', 'Condition aggravated', 'Hypoglycaemia', 'Hypokalaemia', 'Hypotension']",1,MODERNA,IM 1020816,,76.0,F,"Pt with acute resp failure, COVID PNA, that developed symptoms 9 days prior to admit and ultimately received first vaccine 6 days prior toa admit, then shortly after progressed with other covid symptoms and was admitted. She decompensated while intp and was transferred to ICU for rising O2 needs, ultimately had to be intubated. Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle. Sx and IR consulted and did beside exploration of hematoma. Initially blood pressure responded but overnight continued with refractory hypotension. Maxed out vasopressin and levophed, hemodynamics deteriorated. Pt passed soon after(2/2).",Yes,02/02/2021,Not Reported,Yes,9.0,Not Reported,N,01/19/2021,01/25/2021,6.0,PVT,,,,,,"['Abdominal wall haematoma', 'Acute respiratory failure', 'COVID-19 pneumonia', 'Death', 'Endotracheal intubation', 'Haemodynamic instability', 'Hypotension', 'Intensive care', 'Oxygen saturation abnormal']",UNK,PFIZER\BIONTECH,IM 1020830,MD,92.0,F,This resident of the assisted living facility received his Covid-19 Moderna (1st) vaccination and he has a leaking Aortic Aneurysm which resulted in hospitalization and he entered into Hospice care on 1.30.2021 and passed away on 1.30.2021.,Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/30/2021,9.0,PUB,UTO,Leaking Aortic Aneurysm -,Aortic Aneurysm,,None,"['Aortic aneurysm rupture', 'Death']",1,MODERNA,IM 1020859,MO,84.0,F,"Started on Jan 24 or 25-Extreme fatigue, sleeping til late in afternoon,, unable to get out of bed,, headache, just didn't feel right. Went to primary doctor office on 29th. Ran every blood test, ekg and chest xray-mostly normal except orthostatic hypertension. Told to increase fluids. Felt a little better over the next week then same symptoms again Feb 4 and 5th. Took to ER had a seizure and vomiting. CT showed a Stoke and am currently in hospital.",Not Reported,,Yes,Yes,5.0,Yes,N,01/19/2021,01/24/2021,5.0,PVT,"Levothyroxine, Meloxicam, Atorvastatin, Lexapro, vit B12",None,"Thyroid, arthritis",,None,"['Blood test normal', 'Cerebrovascular accident', 'Chest X-ray normal', 'Computerised tomogram abnormal', 'Electrocardiogram', 'Electroencephalogram', 'Fatigue', 'Feeling abnormal', 'Headache', 'Hypersomnia', 'Mobility decreased', 'Orthostatic hypertension', 'Seizure', 'Vomiting']",1,MODERNA,SYR 1020873,OH,67.0,F,"Cerebral stroke. Symptoms onset was documented by nursing home staff on 1/13/21. Second dose of vaccine was received on 1/12/21. I am unsure at this time if it was the Pfizer or Moderna vaccine. Patient has severe defecits at this time but the brain is still healing. Several weeks in the hospital, patient now has peg tube and picc line. Flaccid right side and speech severely impacted.",Not Reported,,Yes,Yes,18.0,Yes,N,01/12/2021,01/13/2021,1.0,SEN,,,Epilepsy,,,"['Central venous catheterisation', 'Cerebrovascular accident', 'Gastrostomy', 'Hypotonia', 'Speech disorder']",2,MODERNA,IM 1020881,AR,31.0,F,"Patient received vaccination at 1:45 P.M. At 1;50 p.m. the patient collapsed. Her throat and tongue were swelling and she was having trouble breathing. She was not unconscious. At 1:52 p.m., epinephrine 0.3mg was administered to patient. She began to recover and swelling started decreasing, She was able to breath again. Shortly after this, the patient began to have more swelling of throat and tongue. Another dose of epinephrine 0.3mg was administered at 1:55 p.m. Again, the epinephrine worked quickly and patient was able to breathe again. The ambulance arrived and took patient to local medical facility.",Not Reported,,Yes,Not Reported,,Not Reported,U,02/10/2021,02/10/2021,0.0,PHM,none listed,none listed; some tachycardia with first vaccination,sometimes gets bad headaches with nausea,tachycardia with first Moderna Covid Vaccine,none listed,"['Dyspnoea', 'Pharyngeal swelling', 'Swollen tongue', 'Syncope']",2,MODERNA,IM 1020898,AR,61.0,M,"Within 24hrs fever, malaise, progressive weakness beginning in the lower extremities and advancing proximally to affect arms. Severe neuropathy",Not Reported,,Yes,Yes,25.0,Not Reported,N,01/14/2021,01/15/2021,1.0,WRK,"Rosuvastatin, HCTZ, nifedipine, albuterol prn, tylenol prn, guiafenissen prn",Rash to the face and chest 6 weeks prior 12/10/20,"OSA, tobacco abuse, COPD, myofascial pain syndrome, essential htn, hx prostate ca",,None,"['Coagulation test', 'Computerised tomogram head', 'Full blood count', 'Liver function test', 'Malaise', 'Metabolic function test', 'Muscular weakness', 'Neuropathy peripheral', 'Procalcitonin', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,IM 1020912,MD,69.0,M,"12 hours following the injection I developed a severe anaphylactic reaction including extreme swelling of lips, tongue, soft palate; difficulty breathing when reclined; difficulty swallowing and difficulty speaking coherently. My wife called 911 and I was transported by ambulance to the ER at Hospital. While enroute I was given epinephrine and Benadryl. I was admitted to the hospital overnight for observation. On February 4th I was evaluated by an allergy specialist who ordered a RAST blood test for food allergies since I had eaten shrimp that day. Tests for all food allergies were negative.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/27/2021,01/27/2021,0.0,OTH,Humalog Levemir Metformin Hydrochlorothiazide Irbesartan Metoprolol Simvastatin Testosterone Aspirin,None,Type II Diabetes Hypertension,,None,"['Anaphylactic reaction', 'Dysphagia', 'Dyspnoea', 'Incoherent', 'Lip swelling', 'Palatal disorder', 'Radioallergosorbent test negative', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 1020919,TX,70.0,M,Temp of 104,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/09/2021,02/10/2021,1.0,SEN,"Eliquis, atorvastatin, Calcium carbonate, metoprolol",,"Diabetic, renal failure, HTN",,Penicillin,['Body temperature increased'],3,PFIZER\BIONTECH,IM 1020924,CA,98.0,F,"Pfizer vaccine, she presents with tremors, hypertension, tachycardia. Pt has a h/o Afib, and she tells me that she has had tremors in her RLE x6 months or so, but that it worsened today. Denies precipitating events. She also had SBPs up to 170's (150's/90's on my interview) and is tachy to 140's in sinus tach. Denies any caffeine today or anxiety or behavioral contributors today, no pain or other stimuli. Pt admits she is feeling jittery when she talks with me, and that taking deep breaths slows her heart rate to 70's-80's. Patient has notable history of cHF with associated LE edema in the past and should strongly be considered as part of this ADE assessment.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/06/2021,02/07/2021,1.0,WRK,"acetaminophen (TYLENOL) 325mg Tab amiodarone (CORDARONE, PACERONE) 200mg Tab Take one Tab by mouth every other day Indications: Paroxysmal Atrial Fibrillation ascorbic acid (VITAMIN C) 500mg TABS Tab Calcium Carb-Cholecalciferol (CA",None known,"Atrial fibrillation, cHF, PAH, Osteoporosis",,"Allergies Bactrim [Sulfamethoxazole W/trimethoprim] Interacted with Amio Doxylamine nauseous Multaq [Dronedarone] Nausea, emesis Mupirocin, Pseudomonas Fluorescens","['Blood pressure increased', 'Condition aggravated', 'Feeling jittery', 'Heart rate decreased', 'Hypertension', 'Tachycardia', 'Tremor']",2,PFIZER\BIONTECH,IM 1020976,MD,68.0,M,"patient developed headache, myalgia and nausea around 8-9 hours post injection. He felt he was having a sickle cell crisis. He worsened overnight and developed acute respiratory failure with respiratory distress and diaphoresis. EMS called around 7am on 2/9 and placed on BIPAP and admitted to ICU",Not Reported,,Yes,Yes,,Not Reported,N,02/08/2021,02/08/2021,0.0,PHM,(1) aspirin: 81 mg = 1 tab PO Daily (2) ciprofloxacin (ciprofloxacin 500 mg oral tablet): 500 mg = 1 tab PO q12h for 10 Day(s) Stop on: Saturday 01-16-21 (3) deferasirox (Jadenu): 720 mg PO Daily (4) DULoxetine: 5 mg PO Daily (5) gabap,CHF exacerbation 1 month prior,"68yo with s/p renal transplant 2011, HbSS anemia, CHF EF 45%, C spine stenosis with C3/C4 myelopathy and cord compression, COVID 4-2020 with subsequent encephalopathy, abnormal LFTs with cirrhosis on imaging, secondary hemochromatosis, hx of falls, chronic pain syndrome, poor venous access, sacral wound, mild cognitive impairment. Diagnoses with acute chest syndrome and TTP 12/2020.",,"ACEI, morphine","['Acute respiratory failure', 'Alanine aminotransferase increased', 'Antibody test negative', 'Aspartate aminotransferase increased', 'Bilevel positive airway pressure', 'Bilirubin conjugated increased', 'Blood bilirubin increased', 'Blood creatinine normal', 'Blood pH normal', 'Brain natriuretic peptide increased', 'Cardiomegaly', 'Clostridium test positive', 'Computerised tomogram thorax abnormal', 'Haemoglobin decreased', 'Headache', 'Heart rate increased', 'Hyperhidrosis', 'Intensive care', 'International normalised ratio increased', 'Lung infiltration', 'Lung opacity', 'Myalgia', 'Nausea', 'Nitrite urine absent', 'PCO2 increased', 'PO2 increased', 'Pleural effusion', 'Pyrexia', 'Respiratory distress', 'Reticulocyte count increased', 'SARS-CoV-2 test negative', 'Sickle cell anaemia with crisis', 'Troponin increased', 'Urine leukocyte esterase', 'White blood cell count increased']",UNK,MODERNA,SYR 1020981,OH,61.0,F,"Approximately 24 hours after given 2nd covid vaccine injection patient was sitting at bedside of a family member that came to hospital ED. She passed out and fell to floor. Lost her pulse and ED staff began CPR. She got her pulse back and woke up and said I am okay. Doctor seeing her ordered labs, EKG, Echocardiogram , chest xray, cardiac enzymes. All tests were normal. ED doctor told patient the only thing they could contribute this to was her covid vaccine she got the day before. She was admitted to the facility for further observation for the next 24 hours.",Not Reported,,Yes,Yes,,Not Reported,Y,02/09/2021,02/10/2021,1.0,PVT,Levothyroxine 25mg daily Tylenol as needed,none,Hypothyroidism,,Morphine,"['Chest X-ray normal', 'Echocardiogram normal', 'Electrocardiogram normal', 'Fall', 'Laboratory test normal', 'Loss of consciousness', 'Myocardial necrosis marker normal', 'Pulse absent', 'Resuscitation']",2,MODERNA,IM 1021013,TX,39.0,F,"Began with fever, tonsillitis, sore throat, sinus drainage, muscle aches. Then on Saturday night the body aches were progressively worse and concentrated on left side of body. Joints were affected including left wlbow, wrist, shoulder. Hot viral rash appeared on arm right above left elbow that became painful with swelling and erythema. In Sunday through the following Wednesday, joint pain continued to worsen and settle in additional joints including first 2 metacarpal bones of both hands almost like arthritic pain. Fingers and joints red and swollen. Pain and swelling next settled in toes of both feet, right side elbow, shoulder and knee. On Monday following vaccine I called employee health and they advised me to come and take covid test. I described symptoms and was told they were side effects of the vaccine and to follow up with a doctor if it continues. My covid test was negative. On the following Thursday I went to urgent care and described my persisting symptoms. I was prescribed a methylprednisolone pack and hydroxyzine. I was told to use naproxen as needed. Yesterday the urgent care sent a check up message. I am still experiencing joint pain although the intensity has decreased but it is still significant pain that is disabling my grip and strengrh overall. The joint pain is mostly just in my upper extremities, hands, fingers and shoulders now consistently. The np prescribed a 10 day pack of meloxicam to try and help minimize the pain.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/27/2021,01/29/2021,2.0,WRK,"Iron, spirinolactone",None,None,,None,"['Arthralgia', 'Asthenia', 'Erythema', 'Grip strength decreased', 'Joint swelling', 'Myalgia', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Rash', 'SARS-CoV-2 test', 'Sinus operation', 'Skin warm', 'Tonsillitis']",UNK,PFIZER\BIONTECH,IM 1021027,CA,84.0,F,"Patient was brought in by ambulance on 01/28/2021 with complaints of fever, chills, myalgias, shakiness, and severe hypotension. Patient was treated for severe sepsis and acute kidney injury. Patient was given fluid resuscitation, but unresponsive to treatment; NE+ vasopressin, hydrocortisone IV, along with empiric antibiotic regimen were initiated. Patient later on developed pulmonary edema, Non-ST elevation MI with no chest pain and new onset of cardiomyopathy with EF 40-45% and clean coronary arteries shown on cardiac catheterization. Physician suspected cytokine release syndrome related to the COVID vaccine and congestive heart failure. Naranjo scale score of 2 indicates possible ADR. MD indicated vaccine reaction unlikely.",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,01/25/2021,01/29/2021,4.0,PVT,atorvastatin 10 mg po qday baclofen 10 mg po tid estradiol 0.1 mg/g vaginal cream qhs ferrous sulfate 45 mg po MWF folic acid 1 mg oral po qd furosemide 20 mg po qd gabapentin 300 mg po tid levothyroxine 75 mcg po qd losartan 25,UTI,"Crohn?s disease, PMR, T2DM, HTN, HLD, hypothyroidism, recurrent UTIs, tinnitus, vertigo",,"Penicillin (hives all over body), Codeine (jittery), Gentamicin (Rash & itching), Erythromycin (Itchiness, rheumatoid arthritis symptoms), Sulfa drug (Itch), Vancomycin (Rash)","['Acute kidney injury', 'Acute myocardial infarction', 'Cardiac failure congestive', 'Cardiomyopathy', 'Catheterisation cardiac normal', 'Chills', 'Cytokine release syndrome', 'Ejection fraction', 'Hypotension', 'Metabolic function test abnormal', 'Myalgia', 'Pulmonary oedema', 'Pyrexia', 'Sepsis', 'Tremor', 'Troponin I increased']",UNK,PFIZER\BIONTECH, 1021038,MO,95.0,F,Patient had passed since the first dose was given.,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,,01/13/2021,01/01/2021,,SEN,,,,,,['Death'],2,MODERNA,IM 1021039,MN,87.0,M,". Patient with increased lethargy, generallized edema, UTI and pneumonia,",Not Reported,,Not Reported,Yes,,Not Reported,N,01/06/2021,01/20/2021,14.0,SEN,"Lactulose, , Tylenol, allopurinol, aspirin, melatonin, Colace, bisacodyl, MiraLAX, oxycodone, tamsulosin, gabapentin, Seroquel, Lyrica, and Xtampza ER","chronic medical conditions, no acute problems identified",". Status post thoracic compression fracture, dementia, rheumatoid arthritis, osteoarthritis, gout, weakness, urinary retention, insomnia, idiopathic neuropathy, macular degeneration, hypertension, spinal stenosis, I TTP, type 2 diabetes, obesity",,None reported,"['Blood culture', 'Blood lactic acid', 'Chest X-ray', 'Fibrin D dimer', 'Full blood count', 'Generalised oedema', 'Lethargy', 'Metabolic function test', 'Pneumonia', 'SARS-CoV-2 test negative', 'Urinary tract infection', 'Urine analysis']",1,MODERNA,SYR 1021040,NE,47.0,M,Pfizer-BioNTech COVID-19 Vaccine Hospital Emergency Room Provider reported cause of death as COVID vaccine administered 11 days prior to death. Additional information being reported from LTCF.,Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/17/2021,11.0,SEN,Unknown - LTCF will also be reporting,Unknown - LTCF will also be reporting,"Obesity, others unknown",,Unknown - LTCF will also be reporting,['Death'],1,PFIZER\BIONTECH,UN 1021045,MO,94.0,F,Patient had passed since the first dose was given.,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,,01/13/2021,02/01/2021,19.0,SEN,,,,,,['Death'],UNK,MODERNA,IM 1021052,MO,93.0,M,Patient had passed since the first dose was given.,Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,,01/13/2021,02/01/2021,19.0,SEN,,,,,,['Death'],2,MODERNA,IM 1021058,MO,72.0,F,Patient had passed since the first dose was given.,Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,,01/13/2021,02/01/2021,19.0,SEN,,,,,,['Death'],2,MODERNA,IM 1021127,FL,54.0,F,Severe thrombocytopenia (Platelets = 5) and diffuse petechial rash to trunk and extremities,Not Reported,,Yes,Yes,,Not Reported,N,01/15/2021,01/01/2021,,UNK,,,,,,"['Full blood count', 'Petechiae', 'Platelet count decreased', 'Rash', 'Thrombocytopenia']",1,PFIZER\BIONTECH,IM 1021153,OR,45.0,F,tremors temp of 104.9 rash pain all over and little zings weak shaking immune system issues,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/03/2021,02/03/2021,0.0,SEN,information unavailable,Massed cell disease,massed cell disease fybromyalgia,,,"['Asthenia', 'Body temperature increased', 'Immune system disorder', 'Pain', 'Rash', 'Tremor']",2,PFIZER\BIONTECH,SYR 1021167,KY,37.0,F,Pain in left eye diagnosed as optic neuritis,Not Reported,,Not Reported,Yes,2.0,Yes,U,01/04/2021,01/11/2021,7.0,WRK,Vitamin c Vitamin d Zinc,None,None,Manatoux tb serum,Penicillin Manatoux tb serum,"['Blood test', 'Eye pain', 'Magnetic resonance imaging', 'Optic neuritis']",2,MODERNA,IM 1021171,IL,84.0,M,"Patient received first dose of Moderna COVID-19 vaccine on 2/3/21. Primary Care physician received call from coroner's office 2/8/21 asking for information contributing to cause of death. Per Primary Care Physician notes, wife states she and patient took turns shoveling snow on 2/4/21. On one trip back into the house she found him unresponsive on the floor and called 911. Paramedics were unable to revive patient and he passed away (2/4/21).",Yes,02/04/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,PVT,"Albuterol, ASA, Zyrtec, D3, CPAP, Zetia, FeSO4, Flonase, Lantus, Atrovent solution, Losartan, Melatonin, Reglan, Metoprolol Succinate, Pantoprazole, Paroxetine, Polyethylene Glycol, Sucralfate, Tamsulosin, Stiolto Respimat","Hypertension, chest pain x 1 month, nausea (1/18/21 primary care visit); memory loss, small left cerebellar infarct (neurology 2/1/21)","HTN, CAD, cerebellar dysfunction, claudication, old myocardial infarction, COPD/dyspnea/sleep apnea, hx thoracic aortic aneurysm, CHF, DM II (insulin dependent), CKD stage 3, anemia, irregular heartbeat, PVC, hx of smoking, atelectasis, BPH, vascular dementia, angina of effort, GERD/abnormal barium swallow/DM gastroparesis, dyslipidemia, depression",,Statin intolerance (muscle tightening),"['Death', 'Unresponsive to stimuli']",1,MODERNA,IM 1021215,,59.0,M,"On Saturday 2/6 unwitnessed fall without loss of consciousness. Gait was unstable, weakness on right side (RUE, RLE) slurred speech, difficulty with finding words. Transported by POV to ED for evaluation of stroke - same sx with onset of parasthesia in right upper arm. Stroke protocol done - received tPA with resolution of symptoms during infusion. Stayed in hospital until protocol completed. Symptoms resolved over the course of the hopsitalization.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/27/2021,02/06/2021,10.0,MIL,"flomax, aspirin 81 gr, zyrtec, advair",none,"asthma, seasonal allergies, prostate enlargement, chronic low back pain, borderline high cholesterol",,"NKDA, seasonal allergies","['Aphasia', 'Cerebrovascular accident', 'Computerised tomogram', 'Dysarthria', 'Echocardiogram', 'Fall', 'Gait disturbance', 'Hemiparesis', 'Infusion', 'Laboratory test', 'Loss of consciousness', 'Magnetic resonance imaging', 'Paraesthesia']",1,PFIZER\BIONTECH,SYR 1021221,PA,68.0,M,"cardiac arrest. Heart stopped, I fell to the ground, and was administered CPR by Police. I was admitted to hospital unresponsive and induced in a coma for two days. MRI results indicated I had a virus in my heart which caused Myocarditis. On 1/25/2021 i Had a cadiac catharization that indicated no blockages, or scar tissue. A defibrillator was surgically implanted in my chest on 1/27/21. Admitted to hospital 1/20/2021. Released 1/28/2021.",Not Reported,,Yes,Yes,7.0,Yes,Y,01/19/2021,01/20/2021,1.0,PVT,"pantropazole, plavix, cialis, multi-vitamin, vitamin c, b-complex, zinc, glucosimine, pro-biotic, eldeberry,",none,,,none,"['Cardiac arrest', 'Catheterisation cardiac normal', 'Fall', 'Implantable defibrillator insertion', 'Magnetic resonance imaging', 'Medical induction of coma', 'Myocarditis', 'Resuscitation', 'Unresponsive to stimuli', 'Viral cardiomyopathy']",1,MODERNA,SYR 1021229,MO,78.0,M,"Patient had a sore arm on the evening of vaccination. The next morning at 8am he had a fever of 103 degrees, violent shaking, and his lips were numb. He was transported by ambulance to the ER and admitted. He received IV therapy and acetaminophen. He states he vomited February 4th. An X-ray was performed on his abdomen and he was given a diagnosis of Ileus. The next day, February 5th, he was able to have a BM and eat. After he was able to eat, he was released from the hospital. Shortly after being released from the hospital his lips started breaking out in fever blisters. He estimates he had 50 or so cold sores and his lips were extremely swollen and red. After seeing his regular health care provider, he started a round of Valcyclovir. On February 10th, the date he reported the adverse reaction, he stated his lips were getting better and he still had more Valcyclovir to take.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/03/2021,02/04/2021,1.0,PHM,"Rosuvastatin, tamsulosin, fentanyl, esomeprazole, metoprolol","Hypertension, hyperdyslipidemia","Hypertension, hyperdyslipidemia",,none,"['Abdominal X-ray', 'Hypoaesthesia oral', 'Ileus', 'Lip erythema', 'Lip swelling', 'Oral herpes', 'Pain in extremity', 'Pyrexia', 'Tremor', 'Vomiting']",1,MODERNA,IM 1021239,IL,48.0,F,"Developed mid to right sided upper abdominal pain that radiated into back on 12/31/20, admitted to hospital on 1/2/21 for pancreatitis along with 2 other admissions (1/16/21 & 1/30/21) for same abdominal pain radiating into back.",Not Reported,,Not Reported,Yes,7.0,Not Reported,U,12/18/2020,12/31/2020,13.0,PVT,"Metformin 500 mg daily, Celexa 20mg daily, Omeprazole 20 mg daily, Zyrtec daily",None,"Hypertension, Diabetes Mellitus Type 2",,Penicillin - nausea Dust Mites,"['Abdominal pain upper', 'Back pain', 'Computerised tomogram abdomen abnormal', 'Hepatobiliary scan', 'Lipase increased', 'Magnetic resonance cholangiopancreatography', 'Pain', 'Pancreatic enlargement', 'Pancreatitis', 'Ultrasound abdomen abnormal']",2,PFIZER\BIONTECH,IM 1021251,OH,40.0,F,"Within 1 1/2 to 2 mins after receiving vaccine pt states starting having an anaphylaxis reaction. Immediately transported to the emergency department. Pt had audible wheezes and stridor noted. Patient was given EPI pen her rt outer thigh. IV started. Pt started having relief within 30 seconds. Wheezing and stridor was decreasing. Pt was also started on a racemic epi neb. Pt placed on monitor and oxygen monitor. One hour later the symptoms of feeling ""throat was swelling off"" returned and EPI 3 mg given and another racemic treatment given. Treated with solumederol, Benadryl and Pepcid. Patient was admitted to the hospital where she remained overnight with no additional symptoms.She was released next day.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,"Epi Pen as needed,Skelaxin, Hydrodiuril, Dexilant, Vivelle, Eliquis, and Xanax",long standing issues only,"CVA, Atrial Fib",,"shellfish, honey, iodine, keflex, morphine,perocet and reglan","['Anaphylactic reaction', 'Blood potassium decreased', 'Full blood count normal', 'Metabolic function test normal', 'Pharyngeal swelling', 'SARS-CoV-2 test negative', 'Staphylococcus test negative', 'Stridor', 'Wheezing']",2,MODERNA,IM 1021319,IA,33.0,M,"Patient received vaccine in AM, had seizure in PM at work with typical post-ictal picture. Has epilepsy but no seizure since 2014. Also has history EtOH misuse but history not consistent with withdrawal. Patient had some waxing and waning altered mental status, worsening slowly over next 2-3 days. Presented to ER with AMS. Initially thought to be EtOH withdrawal, but due to atypical clinical appearance, LP performed and HSV encephalopathy diagnosed.",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,02/03/2021,02/03/2021,0.0,SEN,Keppra Folic Acid/thiamine amlodipine,None known,temporal lobe epilepsy (last seizure 2014) EtOH use disorder,,None,"['Condition aggravated', 'Herpes simplex encephalitis', 'Lumbar puncture abnormal', 'Mental status changes', 'Postictal state', 'Seizure']",UNK,PFIZER\BIONTECH,IM 1021447,WA,80.0,M,"within 2 days of the vaccine he began to feel dizzy, this progressed. he was admitted to hospital 2/1 and was found to have lacunar infarct as well as chronic cholecystitis as well as hypereosinophilia with AEC 4500-11000. no rash or renal failure. he had transamintiis that resolved with treatment of cholecystitis (percutaneous cholecystectomy). eosinophilia work up not yet completed at the time of this report.",Not Reported,,Not Reported,Yes,10.0,Not Reported,N,01/24/2021,01/26/2021,2.0,UNK,"albuterol, aspirin, vit d3, Cymbalta, Flonase, Flovent, Advair, Neurontin, Claritin, vit e,","Sjogrens syndrome (HCC); S Anemia, unspecified; ; Esophageal reflux; Unspecified asthma(493.90); Unspecified sleep apnea; Depressive disorder,","LTBI, prostate cancer s/p prostatectomy, polyneuropathy, osteoporosis,",,levaquin,"['Ascites', 'Basophil count increased', 'Basophil percentage', 'Cholecystectomy', 'Cholecystitis acute', 'Cholecystitis chronic', 'Cholelithiasis', 'Diverticulum', 'Dizziness', 'Eosinophil count increased', 'Eosinophil percentage increased', 'Eosinophilia', 'Gallbladder enlargement', 'Lacunar infarction', 'Lymphocyte count normal', 'Lymphocyte percentage decreased', 'Magnetic resonance imaging brain abnormal', 'Monocyte count increased', 'Monocyte percentage', 'Neutrophil count normal', 'Neutrophil percentage decreased', 'Transaminases increased']",1,PFIZER\BIONTECH,IM 1021530,,36.0,F,Pfizer-BioNTech COVID-19 Vaccine Anaphylaxis reaction Background -I have had one other anaphylaxis event in my history in reaction to horse dander many years ago. As such per the guidance I remained in the waiting room for 30 minutes. After 30 minutes I had a light rash on both forearms and near the injection site on my left upper arm. I felt fine otherwise. I went up to the nurse in the monitoring room and showed her the rash. She asked if I was having trouble breathing. At the time I was not. She said I could take Benadryl for the rash as long as I had no allergy to Benadryl. I started driving home. During my drive my throat started to feel itchy and irritated. It proceeded to get worse and when I looked at my throat in the mirror it was very red and starting to be visibly swollen. I drove to the nearest hospital and checked myself in to the emergency room.,Not Reported,,Yes,Yes,1.0,Not Reported,Y,02/09/2021,02/09/2021,0.0,PVT,,,,,,"['Condition aggravated', 'Differential white blood cell count', 'Full blood count', 'Injection site rash', 'Metabolic function test', 'Oropharyngeal discomfort', 'Pharyngeal erythema', 'Pharyngeal swelling', 'Pregnancy test', 'Rash', 'Throat irritation']",1,PFIZER\BIONTECH,IM 1022902,,72.0,M,"death Narrative: 71 yo male who passed away on 1/29/2021, medical cause of death ""cholangiocarcinoma, interval between onset and death 14 months. Since patient passed away within 42 days of the covid19 vaccine administration, we are required to complete a report to VAERS. Vaccine (Pfizer) was administered without complications. The patient denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy. Synopsis- 1/23 71 yo male presented to ED with upper GI bleed. PMH: DM, HTN, cholangiocarcinoma of biliary tract requiring recurrent paracentesis, COPD, perigastric and lower esophageal varices (not on beta blockers due to bradycardia). Pt has had 2 episodes of coffee ground emesis. Lactic 2.6, ammonia 52. Rec'd protonix, octreotide, and ceftriaxone in ED. Family has been previously encouraged to speak to palliative care but has never been willing to. GI consulted. 1/24 EGD completed. No signs of active bleed. MDs recommending hospice. CT + for small bowel ileus. 1/26 Requires placement of NG tube to suction. Palliative care consulted. 1/27 Paracentesis completed. 4100mls removed. 1/28 Pt changed to palliative status. 1/29 Pt passed away.",Yes,01/29/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/29/2021,10.0,OTH,,,,,,"['Ammonia increased', 'Blood lactic acid', 'Cholangiocarcinoma', 'Computerised tomogram abnormal', 'Death', 'Endoscopy upper gastrointestinal tract normal', 'Gastrointestinal haemorrhage', 'Gastrointestinal tube insertion', 'Haematemesis', 'Paracentesis', 'Small intestinal obstruction']",UNK,PFIZER\BIONTECH,IM 1025150,,62.0,M,"muscle pain, weakness, fatigue-Possible GBS/AIDP Narrative:",Not Reported,,Not Reported,Yes,,Not Reported,U,01/14/2021,01/14/2021,0.0,OTH,,,,,,"['Asthenia', 'Fatigue', 'Myalgia']",1,PFIZER\BIONTECH,IM 1025179,,67.0,M,"Guillain Barre Narrative: 66 y/o male patient received annual influenza vaccine on 9/30/20. Patient began having symptoms on 10/23/20 and was ultimately hospitalized and diagnosed with Guillain Barre at a facility. He received IVIG at this facility for treatment along with PT, OT, speech, and neuropsychological services.",Not Reported,,Not Reported,Yes,,Not Reported,U,09/30/2020,10/23/2020,23.0,OTH,,,,,,"['Guillain-Barre syndrome', 'Immunoglobulin therapy']",UNK,GLAXOSMITHKLINE BIOLOGICALS,IM 1021703,MI,66.0,F,"Client recieved vaccine at 2:28pm. Client was waiting post vaccine and stated she felt funny. RN assessd client. Client co of headache and feeling ""foggy"". Client was a&o x3 vitals were WNL. 2nd RN called to room. Client stated she felt like her tongue was swelling. RN noted swelling of tongue. 911 called, EMS arrived. Assessed client. Client vitals remained WNL. EMS encouraged client to be evaluated by local hospital. Client refused. Client continued to be observed, client stated she felt like the swelling of her tongue was decreasing. EMS felt client could be released from health dept to home. Encouraged client to take bendadryl and to seek medical attention if condition worsened.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,OTH,,,,,,"['Feeling abnormal', 'Headache', 'Swollen tongue']",1,MODERNA,IM 1021707,CA,67.0,F,HEADACHE THE FIRST EVENING CHILLS BUT NO FEVER THE SECOND DAY,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/09/2021,1.0,PUB,"LISINOPRIL, TYLENOL",,HYPERTENSION,,NONE,"['Chills', 'Headache']",1,PFIZER\BIONTECH,SYR 1021711,NC,71.0,F,On day 7 shot location became swollen..hard..3 inch square rash with site beingcwarm likeca fever..I felt nauseated and fatigue ..went away in 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,02/06/2021,7.0,PVT,Fish oil...calcium..probiotic,,Chronic lymphatic leukemia,,Cipro,"['Fatigue', 'Injection site induration', 'Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Nausea']",1,MODERNA,SYR 1021715,NJ,43.0,F,"Headache, chills, body aches, Muscle pain, weak, sweats",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,WRK,N/a,N/a,N/a,,N/a,"['Asthenia', 'Chills', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Pain']",2,PFIZER\BIONTECH,IM 1021718,PA,43.0,F,I began experiencing sharp shooting pain down my left lower leg within 24-28 hours of receiving the shot. The pain occurs often when sitting or laying down. The excruciating sharp pain occurs every time the anus area is wiped from the use of the bathroom or when bathing. The pain feels like an electric shot shooting down my leg that causes me to become unbalanced and at times to tears because it is so painful. It's weird because you do not feel the pain starting from the injection site or even from the buttocks upon wiping; it just shoots from the bottom part of my leg. During the first dose; the pain lasted for over a week. I am now one week out of my second dose and I am still experiencing the discomfort. I did not think anything of it when it occurred during the first dosage until it occurred again in the same left lower leg and in the same manner.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/03/2021,02/04/2021,1.0,PVT,Topical medication for Guttate Psoriasis,,,COVID19 (Moderna),,"['Discomfort', 'Pain', 'Pain in extremity']",2,MODERNA,IM 1021720,CA,70.0,M,"Fever (chills), body ache, nausea and generally feeling bad - Extreme on the first night (couldn't get out of bed.). Lessened the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,PVT,Vitamin D & C,None,None,,Codine,"['Chills', 'Feeling abnormal', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1021722,IL,50.0,F,"I began feeling very tired (9 PM). This progressed to significant chills (9:30 PM) and severe muscle pain and nausea (entire night of 2/8/2021 and 2/9/2021. I remained in bed all day on 2/9/2021, getting up only to use bathroom and get water/little bit of food. Still dizzy and weak on 2/10/2021, though feeling like had turned corner",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/08/2021,0.0,PHM,"Levothyroxine 112 NCH, sertraline hcl 50 mg",None,Cerebral palsy,,Bananas,"['Asthenia', 'Chills', 'Dizziness', 'Fatigue', 'Myalgia', 'Nausea']",1,MODERNA,SYR 1021726,MS,40.0,F,Pain at site of injection upon waking the next morning and in shoulder area. About 15 hours after vaccine. Began to feel moderate body aches all over body with a headache. Began using restroom repeatedly with significant back pain and spasms. Muscle aches and pain continue. This reaction is after the 1st dose and I have had Covid July 2020.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/10/2021,1.0,SEN,"Vitamin C, E, D, probiotic, and Zinc.",,Asthma,,Penicillin,"['Arthralgia', 'Back pain', 'Headache', 'Injection site pain', 'Muscle spasms', 'Pain']",UNK,PFIZER\BIONTECH, 1021728,CA,35.0,F,"Complete numbness in arm where vaccination was received, from hand to the neck for 30-40 minutes roughly 5 hours post vaccine administration. Sore arm for 48 hours. Fatigue for 24-48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/16/2021,01/16/2021,0.0,UNK,Levothyroxine,8 months postpartum,Hypothyroidism,,NO,"['Hypoaesthesia', 'Pain in extremity']",1,MODERNA,IM 1021730,CA,24.0,F,"Strong shooting pain and aches on left side. From neck, to bicep, to forearm, to buttock, to thigh. Each pain is separate. No shooting pain connecting from neck to thigh, but pain staying in localized areas of each body part. Pain from 4pm-10pm Took 1000mg extra strength Tylenol. Pain still here. But manageable",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,PUB,"Doxycycline abx for acne, triamcinolone for eczema",,,,,['Pain'],2,MODERNA,IM 1021731,MO,37.0,M,"Bloody nose, fainting spells, sore arm, insomnia.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/09/2021,1.0,PVT,"Bupropion 150mg, Dextroamphetamine 20mg",None,None,,None,"['Epistaxis', 'Insomnia', 'Pain in extremity', 'Syncope']",2,PFIZER\BIONTECH,IM 1021733,MI,78.0,F,itching and redness on anterior portion of both lower legs,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/07/2021,1.0,PUB,"norvasc, spirolactone, calcium, vitamin d, aleve",back pain due to spinal stenosis,"ARTHRITIS , SPINAL STENOSIS",,none,"['Erythema', 'Pruritus']",2,MODERNA,IM 1021736,AK,65.0,F,"Severe pain in left arm muscle-icing, Tylenol, Advil Headache Nausea, vomitX1",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/09/2021,0.0,PUB,"Progesterone, Estrogen, vit. c, D, Zinc",Fractured L wrist 1/5/2021,Elevated RA Factor,,No known allergies,"['Headache', 'Nausea', 'Pain in extremity', 'Vomiting']",1,PFIZER\BIONTECH,SYR 1021739,CA,39.0,F,"2 days later my arm is hot, firm, with a circular red blotchy trash. It is itchy and tender. It feels tight.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/10/2021,3.0,PUB,None,None,None,,None,"['Feeling hot', 'Induration', 'Pruritus', 'Rash macular', 'Tenderness']",2,MODERNA,IM 1021743,CO,49.0,F,migraine - lasted 3 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"daily vitamin, quinapril 40 mg, metoprolol succinate 25 mg",none,high blood pressue,arm swelling and pain,"bananas, neurontin, gabapentin, darvocet, hydrochodone, anaprox, tylonel, all sulphur drugs, claritan, codine, ixychodone, penicillin, sudafed",['Migraine'],1,MODERNA,IM 1021747,WA,33.0,F,"swollen lymph nodes on left side, same side as the shot was administered. Swollen back of armpit, hurts to touch. Swollen lymph in neck, left side, same side as shot was administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/04/2021,0.0,WRK,"Seasonale birth control, vitamin D supplement, Zyrtec",none,none,,none,"['Axillary pain', 'Lymphadenopathy']",1,MODERNA,IM 1021750,VA,39.0,F,"Burning, tingling parasthesias all over body.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/10/2021,2.0,PUB,Effexor XR 75 mg LoLoestrin FE Women?s multivitamin,None,None,,Penicillins Rocephin,"['Burning sensation', 'Paraesthesia']",2,MODERNA,IM 1021754,CA,81.0,F,"soreness increased to redness, hardness and severe itching at the injection site. Began around 9 days after the shot was given and the hardness under the skin felt like a plate and the skin looks raised and discolored. The hardness has subsided a little but the itching has gotten progressively worse.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/03/2021,9.0,PVT,"Hydrochlorothiazide, Losartan, Potassium CL Women's Silver One a Day Vitamin, Vitamin C, D3, Magnesium, Probiotics",Pace-maker inserted,arthritis,,Sulfur drugs erythromycin hay fever,"['Injection site discomfort', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Rash', 'Skin discolouration']",1,MODERNA,SYR 1021758,CO,49.0,F,"nausea, migraine, hot/cold sweats, chills, fever of 103.5 for over 30 hours, muscle and joint pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,PVT,"daily multi vitamin, quinapril 40 mg, metoprolol succinate 25 mg",had reaction to first Covid shot on 1/7/2021,high blood pressure,arm swelling/pain,"bananas, Neurontin, gabapentin, Darvocet, hydrocodone, anaprox, Tylenol, all Sulphur drugs, claritan, codeine, oxychodone, penicillin, Sudafed","['Arthralgia', 'Migraine', 'Myalgia', 'Nausea', 'Pyrexia']",2,MODERNA,IM 1021762,ID,28.0,F,"After I received my second vaccine shot, approximately 12 hours later I started experiencing symptoms such as: headache, chills, body aches, fatigue, and was lightheaded. Then approximately 24 hrs later a red mark started appearing on my right arm below the injection site. The red mark has become swollen and painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/10/2021,2.0,PUB,,,,,,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Pain']",2,MODERNA,SYR 1021765,WI,46.0,F,"Muscle aches, red swollen warm and itchy at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/09/2021,1.0,PVT,"Ceterizine, duloxetine, lantus,trulicity,advil pm,melatonin,lansoprazole",,"Diabetes mellitus 2, fibromyalgia, barrett's esophagus, environmental allergies",,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Myalgia']",2,MODERNA,IM 1021775,AZ,63.0,F,"Discomfort first few days and then fine On Day 7, redness, pain, swelling, and tightness occurred . Today is day 9. Symptoms still persist. I will send a picture but not sure how to attach to form",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/07/2021,6.0,OTH,"Ezetimibe 10 mg Atenolol 25 mg, bid Lisinopril 20mg Escitalopram 20 mg Cuturelle Stellara injection every 90 days",None,Psoriasis. Metal valve prolapse Anxiety,,Oxycodeine Hydrocodone Demerol Fentanyl Versed Mimocline Solodyn Vicodin Reactions to above listed medication is to pass out Epinephrine causes racing heart,"['Discomfort', 'Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,SYR 1021779,CT,50.0,F,Left axillary lymphadenopathy,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,WRK,,,,,,['Lymphadenopathy'],2,PFIZER\BIONTECH,IM 1021783,GA,68.0,M,"Fever, chills muscle ache, nausea, shivering",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,UNK,aspirin 81 mg/day Olmesartan 40 mg/day,no,no,,sulfa drug allergy,"['Chills', 'Myalgia', 'Nausea', 'Pyrexia']",2,MODERNA,IM 1021786,FL,39.0,F,At 12 hour post vaccine a began feeling achy. Within an hour I had chills and felt feverish. I went to bed. Woke up at 12:30 am on 12/11 and took my temp. 101.4 with a sweatshirt on. Infection site arm is very sore. Overall I just feel really lousy. My husband is fine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/10/2021,9.0,PVT,Lexapro Zinc Multivitamin Vitamin D B 12 Magnesium calcium,,,Warm adenopathy and lymph node soreness at injection site one week after covid dose 1,,"['Chills', 'Injection site discomfort', 'Pain', 'Pyrexia']",2,MODERNA, 1021791,CA,50.0,F,Sever underarm pain after 24 hours. Pain subside with Tylenol dose. pain keep coming back after every 8-10 hours. Redness and itchy reaction after 48 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/09/2021,1.0,OTH,Thyroxine,None,None,,Sulpha,"['Injection site erythema', 'Injection site pruritus', 'Pain in extremity']",2,MODERNA,SYR 1021794,FL,71.0,F,"Admitted to the Emergency Room. Reason for visit: Allergic Reaction. Diagnosis: Adverse effect of drug, initial encounter. Following issue addressed: High priority for COVID-19 virus vaccination. Three (3) hours in the emergency room. Short of breath/Yawning/Difficulty breathing/Trouble with breathing/Dried mouth. Blood pressure sky rocked. Muscles pain days after. Due to my reaction, after first dose, Dr recommend me not to take the second dose of the vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/18/2021,01/18/2021,0.0,PVT,Vitamin D 2000,None,None,,Renografin 76 - Iodine - Vitamin C - Bioxin - Cipro.,"['Blood test', 'Chest X-ray', 'Dry mouth', 'Dyspnoea', 'Electrocardiogram', 'Hypersensitivity', 'Hypertension', 'Myalgia', 'Yawning']",1,MODERNA,IM 1021797,CA,78.0,M,"Sore and inflamed left arm and red rash. headache medium, fever 100.4 thru 100.8 for about 42 hours starting early Saturday morning after a Friday inoculation, and ending Sunday evening. Woke up Monday feeling well and no after-effects. Took some tylenol during the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,PUB,"Metformin, Aspirin, Farxiga, Creon, Warfarin, Vitamin D, CQ10, Multi-vitamins, Januvia, Lipitor",None,"Diabetes-2, Liver Cirrhosis, Heart arrhythmia, Pancreatitis,",,Latex adhesive,"['Erythema', 'Headache', 'Limb discomfort', 'Pyrexia', 'Rash']",2,MODERNA,SYR 1021802,,26.0,F,"delayed induration, redness. Brief numbness to hand x 1 day.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/07/2021,5.0,MIL,none,none,none,,none,"['Erythema', 'Hypoaesthesia', 'Induration']",1,MODERNA, 1021805,HI,25.0,F,"Symptoms include fatigue, headaches, redness, tender, itchy, welted, warm to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/01/2021,02/01/2021,0.0,UNK,Birth Control (Loryna),,,,Dairy intolerance,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Urticaria']",2,MODERNA,SYR 1021808,CA,72.0,F,"slight numbness around jaw and down sides of neck, heart beat racing ( it lasted about 10 minutes)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,OTH,"Olmesartan, Metoprolol, Jardiance, Metformin, Bupropion, Duloxetine, Atorvastatin, Cephaloxin",sinus infection,"hypertension, diabetes 2",,None,"['Electrocardiogram', 'Hypoaesthesia', 'Palpitations']",1,MODERNA,SYR 1021812,,31.0,M,"Chills, fever (100.2F), headaches, body ache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/11/2021,1.0,OTH,None,None,None,,None,"['Chills', 'Headache', 'Pain', 'Pyrexia']",2,MODERNA,SYR 1021816,CA,34.0,F,"5 minutes after injection, I felt tingling in my fingertips and toes. Two and a half hours after injection, I had an insatiable craving for cheese and other dairy products that lasted approximately 12 hours after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,PUB,"Singulair, Mirena, multivitamin, fish oil, chia seed capsules, and not so tall",None,"Obesity, polycystic ovary syndrome, costochondritis, asthma, ADHD",,"Cats, Ragweed, mold","['Food craving', 'Paraesthesia']",UNK,MODERNA,SYR 1021819,CA,49.0,F,"On 2/9/21, I noticed a bump at the exact injection site. It was red, raised and about the size of a large pimple. It was itchy and warm. The next day, around 1pm, the bump had flattened and a large rash had appeared around and below the injection site. The rash is red, blotchy, itchy, tingly and warm. My skin in the area feels right. I emailed my doctor and have not heard back yet. It is currently about 9 hours after the appearance and of the rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/09/2021,8.0,PVT,Estradiol 2mg; progesterone micronized 100mg; loratadine 10mg; Sudafed 24 hour; fluticasone propionate 50mcg; cequa .09; gabapentin 100mg; centrum silver women multivitamin; vitamin c 1000mg; CoQ10 200mg; vitamin d 5000 iu; l-lysine 1000mg,Seasonal respiratory allergies,"Peri-menopause; dry eyes; herpes, and migraines",,Tramadol and blue food coloring,"['Injection site erythema', 'Injection site paraesthesia', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 1021825,CA,68.0,M,White part of right eye has broken blood vessels. 1/2 of eye is bright red. Eye is scratchy but no other problems. Has never happened before. Noticed about three hours after injection,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/10/2021,02/10/2021,0.0,PUB,prozac Atenolol Lisinopril,None,High blood pressure,,"Cats, dogs, horses, hey fever, iodine",['Ocular hyperaemia'],1,MODERNA,SYR 1021829,NY,28.0,F,"After first shot on 12/24/2020, I noticed a small rash on my right arm that was quite itchy. After my second dose on 1/14/2021, my rash and itching grew and now I am covered from my neck down to my ankles. I am covered in a red rash/hives, and this is incredibly itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,PVT,"Metoprolol tartrate, Hydrochlorothiazide",none,"I have paroxysmal atrial tachycardia, psoriasis",,"lamictal, gabapentin, iodine","['Pruritus', 'Rash', 'Urticaria']",2,PFIZER\BIONTECH,IM 1021833,OR,32.0,F,"First day after receiving my second vaccination at 12:30, I became very puky and threw up the rest of the day along with my arm that the vaccination was received went dead. The following day I regained feeling in my left arm off and on throughout the day and had body aches, chills, and had shortness of breath. Day three I began to feel better with occasional shortness of breath and I had feeling in my arm again. I was completely back to normal by day four.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,PVT,,,Athsma,"31, 12/28/2020, Moderna dose #1, I lost complete feeling of my left arm for the whole first day,",,"['Chills', 'Dyspnoea', 'Injected limb mobility decreased', 'Nausea', 'Pain', 'Vomiting']",2,MODERNA,IM 1021835,WA,52.0,F,"Initial not concerning: Bad headache the next morning which passed by the end on the day. Injection site swelling and discomfort for a few days. The reason I am submitting this form is fatigue, mild diarrhea, moderate nausea, and vomiting starting 8 days after the vaccine. So far it's nothing serious. I haven't been out to catch anything so it seems related. I thought you may want the data because of the strang delay in gastrointestinal symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/03/2021,1.0,WRK,,,Gastrointestinal issues and glaucoma,,Prescription pain medication causes uncontrollable vomiting,"['Diarrhoea', 'Fatigue', 'Headache', 'Injection site discomfort', 'Injection site swelling', 'Nausea', 'Vomiting']",1,MODERNA,SYR 1021915,NY,,U,"felt dizzy; VIRAL INFECTION FOLLOWING; This case was reported by a physician via sales rep and described the occurrence of dizziness in a patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and MENACTRA for prophylaxis. On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Influenza vaccine Quadrivalent unspecified season and MENACTRA. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Influenza vaccine Quadrivalent unspecified season, the patient experienced dizziness and viral infection. On an unknown date, the outcome of the dizziness and viral infection were unknown. The reporter considered the dizziness and viral infection to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the reporter considered the dizziness and viral infection to be related to Influenza vaccine Quadrivalent unspecified season. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: The case was reported by the mother. The age at vaccination was not reported. The patient felt dizzy, followed by viral infection. The mother of the patient looked up Meningococcal B and was convinced that it was pulled up adverse reaction. She did not want to report it because it was 3 vaccines. It was unknown if the reporter considered the dizziness and viral infection to be related to Menectra. This case had been linked with US2020AMR261157 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR261157:Same reporter",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Dizziness', 'Viral infection']",UNK,SANOFI PASTEUR, 1021916,NJ,91.0,M,"Stomach bleed from blood thinners; Tested positive for COVID-19; A spontaneous report was received from a consumer concerning a 91-year-old, White, male, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a positive Covid-19 test and the serious adverse event of stomach bleed from blood thinners. The patient's medical history, as provided by the reporter, included dialysis three times a week with a port in his left arm, broken hip, and stomach bleed. No medication allergies reported. Concomitant medications reported included acetylsalicylic acid and multiple medications not otherwise specified. On an unknown date prior to receiving the vaccine, the patient began to experience stomach bleed. He was hospitalized and discharged before the vaccination. On 30 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot number 025J20A, expiration date 29 Jun 2021) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 30 Dec 2020, after the injection, the patient was tested for Covid-19, and the results were positive. On an undisclosed date purported to be two weeks after vaccination, the patient was hospitalized due to a stomach bleed from blood thinners, and an unknown blood vessel procedure was performed. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, tested positive for Covid-19 and stomach bleed from blood thinners, was not reported.; Reporter's Comments: A spontaneous report concerns a 91-year-old, White, male, patient, with medical history of dialysis three times a week with a port in his left arm, broken hip, and stomach bleed, who experienced a positive Covid-19 test and the serious event of stomach bleed from blood thinners. The event of positive Covid-19 test occurred on the same day after the administration of the first dose of mRNA-1273 (Lot number 025J20A, expiration date 29 Jun 2021) and stomach bleed occurred on an unknown date after the vaccine administration. Treatment for stomach bleed included blood vessel procedure. Based on the information provided, there is not a definite association between the vaccine administration and the reported events. Use of blood thinners could have contributed to the event of Stomach bleed, also confounded by the patient's medical history of stomach bleed and concomitant use of acetylsalicylic acid. COVID positive test was obtained on the same day as vaccination and unlikely to have resulted from mRNA-1273 administration.",Not Reported,,Not Reported,Yes,,Not Reported,U,12/30/2020,12/30/2020,0.0,UNK,BABY ASPIRIN,"Dialysis (three times a week, port in left arm); GI bleed",Medical History/Concurrent Conditions: Broken hip,,,"['COVID-19', 'Condition aggravated', 'Gastrointestinal haemorrhage', 'SARS-CoV-2 test positive']",1,MODERNA,OT 1021917,NY,90.0,M,"Syncope; Shaking; Struggling to breathe; A spontaneous report was received from a consumer concerning a 90-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed syncope, shaking, and struggling to breathe. The patient's medical history was not provided. Concomitant medications reported included warfarin, ezetimibe, bupropion, finasteride, tamsulosin, furosemide, potassium chloride, rosuvastatin, and nitrofurantoin. On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, after vaccine administration, the patient stayed at the vaccination site for fifteen minutes to watch for any reaction, he had none, so he left. Later that night the patient began shaking and struggling to breathe, so 911 was called. At the hospital, the patient was diagnosed with syncope. He spent overnight in the hospital and had an echocardiogram the following day. No results were provided for the echo, but the patient was cleared to go home after a sixteen-hour hospital stay. No treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events, syncope, shaking, and struggling to breathe, was resolved.; Reporter's Comments: This case concerns a 90 year-old, male patient, who experienced events of syncope, shaking, and struggling to breathe. The events occurred the same night after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,WARFARIN; EZETIMIBE; BUPROPION; TAMSULOSIN; FINASTERIDE; FUROSEMIDE; POTASSIUM CHLORIDE; CRESTOR; NITROFURANTOIN,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Dyspnoea', 'Echocardiogram', 'Syncope', 'Tremor']",1,MODERNA,OT 1021918,CA,58.0,F,"Flushed; Body aches; Red rashy spot; Fatigued; The site on my left arm got to a baseball size; Headaches; Felt like I would throw up; Ended up fainting/ went down for a second time; Diarrhea; Light headed; Discombobulated; A spontaneous report was received from a 58 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea, felt that she would throw up, light headed, fainted, discombobulated, site on her left arm got to a baseball size, and in the middle was a red rashy spot, flushed, fatigued, had body aches and headaches. The patient's medical history included high blood pressure. Relevant concomitant medications included unknown blood pressure medication. On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 011J20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 21 Jan 2021, around three, the patient experienced diarrhea, she thought it was food poisoning. While on the ""pot"" with diarrhea she felt that she would throw up. She mentioned that she became lightheaded but did not throw up and ended up fainting. She fell off the pot and decided to lay down in her bed. She got lightheaded again and went down for a second time. She stated she had a difficult time getting up; she crawled to the bed. When she attempted to stand up, she could feel she was lightheaded again. The patient mentioned that maybe she was down 45 minutes before getting to lay on her bed. She felt discombobulated. She felt very clumsy when trying to dial her sister's number; she left a message on the machine and was struggling to get her words together. The site on her left arm got to a baseball size, and in the middle was a red rashy spot. On Friday evening, 26 Jan 2021, the patient stated she started feeling better. She mentioned that she was flushed, fatigued and had body aches. The patient stated she hasn't tried any treatments but took paracetamol for headaches and tried to rest. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, diarrhea, felt that she would throw up, light headed, fainted, discombobulated, site on her left arm got to a baseball size, and in the middle was a red rashy spot, were resolving. The outcome of the events, headaches, flushed, fatigued and body aches, were unknown.; Reporter's Comments: This case concerns a 58 year old female patient with medical history of high blood pressure, who experienced a serious unexpected event of Syncope and NS unexpected events of diarrhea, nausea, dizziness, confusional state, injection site swelling, rash erythematous, flushing , fatigue, pain and headache. The events occurred approximately 8 days after first dose of the study medication administration. she only took paracetamol for headaches and tried to rest without any other treatment. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/21/2021,8.0,UNK,,Hypertension,,,,"['Clumsiness', 'Diarrhoea', 'Dizziness', 'Dysstasia', 'Fall', 'Fatigue', 'Feeling abnormal', 'Flushing', 'Headache', 'Injection site swelling', 'Mass', 'Nausea', 'Pain', 'Rash erythematous', 'Syncope']",1,MODERNA,OT 1021919,FL,87.0,F,"Death; kidney failure (unable to urinate); shortness of breath; required oxygen; A spontaneous report was received from consumer concerning an 87-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, kidney failure and death. The patient's medical history included advanced kidney and heart disease. No relevant concomitant medications were reported. On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 17 Jan 2021, the husband reported that the patient experienced adverse events. Symptoms included shortness of breath and kidney failure (unable to urinate). The patient was admitted to the hospital and discharged to hospice. Oxygen was administrated for shortness of breath. Action taken with mRNA-1273 in response to the events was not applicable. On 20 Jan 2021, the patient died. The cause of death was unknown. Autopsy details were unknown.; Reporter's Comments: This case concerns a 87-year-old, female patient with the medical history of advanced kidney and heart disease, who experienced fatal unexpected event of dyspnea, renal failure and death. The events of dyspnea and renal failure occurred 12 days and the event of death occurred 15 days after the first dose of mRNA-1273 (Lot: unknown). The patient was admitted to the hospital and discharged to hospice. Oxygen was administrated for shortness of breath. The cause of death was unknown. Autopsy details were unknown. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the history of advanced kidney and heart disease may remain as confounder. Additional information has been requested.; Reported Cause(s) of Death: Unknown cause of death",Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/17/2021,11.0,UNK,,"Heart disease, unspecified; Renal disease",,,,"['Death', 'Dyspnoea', 'Oxygen therapy', 'Renal failure', 'Urinary retention']",1,MODERNA,OT 1021920,GA,,F,"Also gagged a couple of times, but not really a stomachache; little bit of a headache; temperature of 101 with first shot; Cellulitis really bad right now; A spontaneous report was received from a consumer who was also a 66-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis really bad right now, gagged a couple times, but not really a stomachache, temperature of 101 degrees Fahrenheit and a little bit of a headache. The patient's medical history included what she described as having reactions to things sometimes, and has an Epi-Pen, however has never ever used it. On 26 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 31 Jan 2021, the patient increase in body temperature to 101 degrees Fahrenheit. On 01 Feb 2021, approximately one week after receiving the mRNA-1273 vaccine, the patient reported a visit to her physician. She has cellulitis really bad right now. She also reports a little bit of a headache and that she had gagged a couple times but not really a stomachache. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, cellulitis really bad right now, gagged a couple times, but not really a stomachache, temperature of 101 degrees Fahrenheit and a little bit of a headache were not reported.; Reporter's Comments: This case concerns a 66 year-old, female patient, who experienced events of a temperature of 101 degrees Fahrenheit, cellulitis really bad right now, a little bit of a headache, and also gagged a couple times. The events occurred approximately 1 week after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,02/01/2021,6.0,UNK,EPIPEN,,"Medical History/Concurrent Conditions: Allergic reaction (Patient has an Epi-pen due to having reactions to things before however, has never used it.)",,,"['Body temperature increased', 'Cellulitis', 'Headache', 'Retching']",UNK,MODERNA,OT 1021921,NJ,56.0,M,"Heart rate dropped to 30; A spontaneous report was received from consumer concerning a 56 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient's heart rate had dropped to 30. The patient's medical history was organ transplant. Concomitant product use was not provided. On 22-Jan-2021, the patient received the first of two planned doses of mRNA-1273, Batch number 011J20A, intramuscularly for prophylaxis of Covid-19 infection. On an unknown date, the patient's ""heart rate was dropped to 30"". He was hospitalized for 6 days. Treatment medication was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was unknown.; Reporter's Comments: This case concerns a 56 year old male patient with relevant medical history of organ transplant who received the first of two planned doses of mRNA-1273 (Batch number 011J20A) intramuscularly for prophylaxis of Covid-19 infection and experienced a serious unlisted event of decreased heart to 30 and was hospitalized for six days. Treatment details not provided. Very limited information regarding this event has been provided at this time which precludes a proper medical assessment and in addition, patient's history of organ transplant may provide an alternative explanation and the event is unlikely related to the vaccine. Further follow has been requested.",Not Reported,,Not Reported,Yes,6.0,Not Reported,U,01/22/2021,01/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Transplant,,,['Heart rate decreased'],1,MODERNA,OT 1021922,KY,,M,"Chest pain; Acute Myocarditis; Fever; A spontaneous report was received from a healthcare professional concerning a 35-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed chest pain, myocarditis, and fever. The patient's medical history included COVID-19 in Oct of 2020. No relevant concomitant medications were reported. On 29 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (lot number or batch number not provided) intramuscularly (in the left arm) for prophylaxis of COVID-19 infection. On an unknown date after receiving vaccine the patient developed a fever and chest pain. On 31 Dec 2020 the patient was admitted to the hospital where a heart catheterization was done-negative results. The patient was diagnosed with myocarditis. He was scheduled to receive his second dose of vaccine on 03 Feb 2021. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events chest pain, myocarditis, and fever were not reported.; Reporter's Comments: This case concerns a 35-year-old, male patient with a medical history of COVID-19, who experienced a serious unexpected event of chest pain, myocarditis and an expected event of pyrexia. The events of chest pain and pyrexia occurred on an unspecified date and the event of myocarditis occurred 3 days after the first dose of mRNA-1273. A heart catheterization was done-negative results.Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,12/29/2020,12/31/2020,2.0,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Catheterisation cardiac normal', 'Chest pain', 'Myocarditis', 'Pyrexia']",1,MODERNA,OT 1021923,GA,,M,"Pneumonia; 104 Fever; A spontaneous report was received from a consumer who was also a 71-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 104 fever and pneumonia. The patient's medical history was not provided. No relevant concomitant medications were reported. On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 19 Jan 2021, after receiving the vaccination, the patient reported a 104 degrees Fahrenheit fever. The patient went to his health care provider (HCP). X-ray was taken. Pneumonia was diagnosed. Treatment included prednisone, antibiotic and nebulizer. The patient was also prescribed albuterol but did not use. On 21 Jan 2021, the fever had resolved. On 29 Jan 2021, the subject returned to the doctor. On the same day, pneumonia was gone. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the event was reported 104 fever was resolved on 21 Jan 2021. The outcome for the event pneumonia was reported resolved on 29 Jan 2021.; Reporter's Comments: This case concerns a 71-year-old male subject, who experienced a serious unexpected event of Pneumonia, and non-serious expected event of Pyrexia. The events occurred same day after the first dose of the mRNA-1273 administration. Treatment included prednisone, antibiotic and nebulizer. Pyrexia resolved 2 day after, and Pneumonia resolved 10 days after first dose of vaccination. Since Pneumonia has insidious onset rather than acute onset, the event was possibly caused by underlying condition confounded by elderly age of patient. Very limited information regarding these events have been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event of Pneumonia and Pyrexia, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No patient history reported.),,,"['Pneumonia', 'Pyrexia', 'X-ray abnormal']",1,MODERNA,OT 1021924,FL,,F,"Anaphylactic shock; A spontaneous report was received from a consumer who is also a 71-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis. The patient's medical history was not included. Products known to have been used by the patient were not provided. On 27 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, after the mRNA-1273 vaccine was being given, the patient noted anaphylaxis symptoms, was rushed to the hospital and hospitalized for 24 hours. Treatment information included hospitalization, epinephrine and breathing treatments. Action taken with mRNA-1273 will be discussed with her physician. The outcome of the event anaphylaxis was unknown.; Reporter's Comments: This case concerns a 71-year-old female patient. The medical history is not provided. The patient experienced a serious unexpected event of Anaphylactic reaction on the same day after receiving their first of two planned doses of mRNA-1273 (Lot # 029L20A). Treatment included epinephrine and breathing treatments. Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.",Not Reported,,Yes,Yes,1.0,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical history not provided),,,['Anaphylactic reaction'],1,MODERNA,OT 1021925,SC,88.0,F,"Broke Hip at Assisted Living; Fell; Tested positive for COVID-19; A spontaneous report was received from a daughter concerning a 88-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and fell and fractured hip, and tested positive for COVID-19. The patient's medical history, as provided by the reporter, included Alzheimer's and behavioral problems. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient fell and fractured her hip at her assisted living facility, and was hospitalized. Treatment for hip fracture was not provided. On 29 Jan 2021, at the hospital, she subsequently tested positive for COVID-19. Treatment included oxygen through 30 Jan 2021. On 01 Feb 2021, it was reported that the patient was not on a ventilator. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events fell and fractured hip and tested positive for COVID-19 were unknown at the time of this report.; Reporter's Comments: This case concerns a 88 year old female with medical history of Alzheimer's and behavioral problems, who experienced a serious unexpected events of fall and hip fracture 12 days after the first dose of mRNA-1273. Information on treatment not provided. On 29-Dec-2021, she had a serious unexpected event of COVID-19 18 days after mRNA-1273, requiring supplemental oxygen. Based on the current available information and temporal association between the of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/12/2021,01/23/2021,11.0,UNK,,Alzheimer's disease; Behavior abnormal (Behavioral problems),,,,"['COVID-19', 'Fall', 'Hip fracture', 'SARS-CoV-2 test positive']",1,MODERNA, 1021926,,,F,"Passed away; Positive result; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed COVID-19 and passed away. The patient's medical history was not provided. Concomitant product use was not reported. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 08 Jan 2021, the patient had a positive COVID-19 test. On 18 Jan 2021, the patient passed away. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 18 Jan 2021. The cause of death was not reported.; Reporter's Comments: This spontaneous report concerns a female patient who experienced COVID-19 and passed away. The event of COVID-19 occurred 4 days after the first and only dose of the mRNA-1273 vaccine administered and death occurred 14 days after administration of the mRNA-1273 vaccine. Based on the information provided and the known etiology of COVID-19, it is unlikely to be associated with mRNA-1273 vaccine administration. With no definite information on the clinical details of the death, it is difficult to adequately assess a causal association with mRNA vaccine. Main field defaults to �possibly related'; Reported Cause(s) of Death: unknown cause of death",Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/08/2021,3.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",1,MODERNA,OT 1021959,FL,69.0,F,"deyhydration; sick; sinus tachycardia; diarrhea; Fever over 102 degrees Fahrenheit; chills; headache; body aches; fatigue; dizziness; Pfizer COVID-19 Vaccine on 12Jan2021 with immunosuppressant mesalamine; Pfizer COVID-19 Vaccine on 12Jan2021 with immunosuppressant mesalamine; will fall asleep through the day for 3-4 hours at a time and she does not even nap usually; Muscle pain; Neck ache; Backache; Problems with walking; problems with balance; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3246), via an unspecified route of administration on the left arm on 12Jan2021 14:30 at a single dose for covid-19 immunization. Vaccine was not administered in a military facility. Medical history included ongoing ulcerative colitis, ongoing high cholesterol, ongoing high blood pressure, celiac disease from 2005 (this has been tested too many times to count and it has been negative since after initial diagnosis 2005), arthritis (all her life) ongoing, hip replacement surgeries first done in 2005; repair of same hip in 2015; other hip in 2017. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccines include Pneumonia Vaccine, Shingles Vaccine and Flu vaccines; all on an unspecified date for immunization. She never had adverse events with those. Ongoing concomitant medications included rosuvastatin (5 mg tablet) for high cholesterol, mesalamine (400 mg capsule) for ulcerative colitis and lisinopril from 2018 for high blood pressure. According to the patient, she knows that mesalamine is an immunosuppressant and anti-inflammatory to keep inflammation in the colon down. This consumer was administered her first dose of Pfizer COVID-19 Vaccine on 12Jan2021 14:30 with immunosuppressant mesalamine. The night of 14Jan2021 patient had headache, chills, body aches, diarrhea, fatigue, fever and dizziness like Covid 19 symptoms. She went to the ER during the past 11 days for IV fluids due to deyhydration from the diarrhea. Today, 25Jan2021 is the first day she has been out of the house, except to go to the ER, since she received her 1st vaccine dose. On Jan2021 muscle pain, neck ache, backache, problems with balance and problems with walking. Events probably started with intense diarrhea starting 14Jan2021; then Fever over 102 degrees Fahrenheit and chills 14Jan2021; Specific onset dates and onset times unknown otherwise other than between 14Jan2021 and 16Jan2021 onset dates. It was a rolling week of agony after that with one adverse event after another until she ended up in the emergency room on 16Jan2021 because she was so dehydrated and was really sick. She was not admitted to the hospital related to any of these events; but while in the emergency room she was given intravenous fluids; a chest x-ray; blood work; after maybe 5-6 hours she was sent home; she was also given a COVID test which was negative; and then 2 days later took another COVID test which was also negative. Both COVID tests were Rapid Tests: on 16Jan2021 and 18Jan2021. On the Chest xray they suggested she had some sinus tachycardia which is just a rapid heartbeat and not surprising; nothing else showed up on Chest x-ray; as far as anything else testing/results wise there was only some facetious blood work which they just said to follow-up with her PCP regarding but nothing really out of the ordinary. She can finally out of bed on a regular basis for a couple of hours daily; she is still very fatigued; she has no muscle pain, neck aches or body aches at this time; she does not have the strength she should have; is no longer experiencing headaches or fever; but is extremely tired. She will fall asleep through the day for 3-4 hours at a time and she does not even nap usually (Jan2021). She has not driven yet but assumes probably once she is a little stronger she will be able to drive again. She did not have upper respiratory, chest or cough issues. The outcome of the events fever, headache, body ache, muscle pain, neck ache was recovered on Jan2021; fatigue was not recovered. The outcome for the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/01/2021,,UNK,ROSUVASTATIN; MESALAMINE; LISINOPRIL,Arthritis; Blood pressure high; High cholesterol; Ulcerative colitis,Medical History/Concurrent Conditions: Celiac disease; Hip replacement,,,"['Asthenia', 'Back pain', 'Balance disorder', 'Blood cholesterol increased', 'Blood immunoglobulin A', 'Blood test', 'Chills', 'Dehydration', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Gait disturbance', 'Headache', 'Heart rate increased', 'Hypertension', 'Immunosuppressant drug therapy', 'Loss of personal independence in daily activities', 'Malaise', 'Myalgia', 'Neck pain', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Serology normal', 'Sinus tachycardia', 'Somnolence', 'X-ray abnormal']",1,PFIZER\BIONTECH, 1021971,NJ,47.0,F,"Hives on face and neck worsening to stridorous breath sounds.; Hives on face and neck worsening to stridorous breath sounds.; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 21Jan2021 10:15 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included asthma, ulcerative colitis, sub clinical Hashimotos, and known allergies to eggs and dairy. Concomitant medication included mesalamine (MESALAMINE), levocetirizine dihydrochloride (XYZAL), budesonide, formoterol fumarate (SYMBICORT), procaterol hydrochloride (PRO-AIR), and montelukast sodium (SINGULAIR). The patient previously received the first dose of bnt162b2 on 31Dec2020 09:30 in left arm(lot number: EL0142) for COVID-19 immunization. The patient experienced hives on face and neck worsening to stridorous breath sounds on 22Jan2021 12:00. The outcome of the events was recovering. The event resulted in an emergency room/department or urgent care. Treatment included Epinephrine, Benadryl, Prednisone. The patient did not have CVOID-prior to vaccination and was not tested for COVID-19 post vaccination.; Sender's Comments: Based on currently known drug safety profile, a causal association between the reported events hives on face and neck worsening to stridorous breath sounds and bnt162b2 cannot be excluded. The patient's underlying risk factors/predisposing condition asthma is considered as a risk factor to develop the event stridorous breath sounds. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/22/2021,1.0,PVT,MESALAMINE; XYZAL; SYMBICORT; PRO-AIR; SINGULAIR,,Medical History/Concurrent Conditions: Asthma; Egg allergy; Hashimoto's disease; Milk allergy; Ulcerative colitis,,,"['Stridor', 'Urticaria']",2,PFIZER\BIONTECH, 1021978,PA,57.0,F,"rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp remaining at 95 degrees; stomach pain; dizziness; weakness; severe fatigue; severe headache; nausea; injection site pain; lack of appetite or thirst; lack of appetite or thirst; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date was not reported), intramuscular on 07Jan2021 15:30 at single dose on the left arm for covid-19 immunization. Medical history included PTSD, CRPS, anxiety, and chronic pain. The patient has no allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and clonazepam. On 21Jan2021 at 16:00, the patient experienced severe chills and hot flashes with temp remaining at 95 degrees, stomach pain, dizziness, weakness, severe fatigue, severe headache, nausea, injection site pain, lack of appetite or thirst. On 26Jan2021, the patient experienced rectal bleeding (medically significant). It was reported that the patient received Zofran and she missed her work days. The patient had a clinic visit to her doctor. It was reported the patient was not diagnosed with COVID-19 prior to vaccination. The patient had Nasal Swab on 25Jan2021 with negative results. The patient has not recovered from all of the events at the time of the report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/21/2021,14.0,PVT,PERCOCET; CLONAZEPAM,,Medical History/Concurrent Conditions: Anxiety; Chronic pain; Complex regional pain syndrome; Post-traumatic stress disorder,,,"['Abdominal pain upper', 'Asthenia', 'Body temperature decreased', 'Chills', 'Decreased appetite', 'Dizziness', 'Fatigue', 'Headache', 'Hot flush', 'Impaired work ability', 'Injection site pain', 'Nausea', 'Rectal haemorrhage', 'SARS-CoV-2 test negative', 'Thirst decreased']",1,PFIZER\BIONTECH,OT 1021979,MA,68.0,M,"Contacted COVID-19 and currently with Cory a symptoms; Contacted COVID-19, tested positive; This is a spontaneous report from a contactable physician reporting for himself. A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number=EL3246, via an unspecified route of administration on 12Jan2021 14:00 (at the age of 68 years old) as a SINGLE DOSE in the left arm for Covid-19 immunization. Medical history included Sulfa allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical information included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EK5730, first dose in the left arm on 22Dec2020 (at the age of 68 Years old) at 02:00 PM for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. The patient contacted COVID-19, tested positive on 22Jan2021 and currently with ""Cory a symptoms"". The events were non-serious. No treatment was received for the adverse events.The patient underwent lab tests and procedures which included post vaccination=Nasal Swab: COVID test result positive on 22Jan2021. Outcome of the events was unknown. Prior to vaccination, the patient was not patient diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and suspected LOE. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/22/2021,10.0,PVT,,,Medical History/Concurrent Conditions: Sulfonamide allergy (Sulfa allergy),,,"['COVID-19', 'Rhinitis', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 1021981,MI,,F,"joint pain in right shoulder causing issues with using my right arm as normal; joint pain in right shoulder causing issues with using my right arm as normal; This is a spontaneous report from a contactable nurse (patient). A non-pregnant female patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:), intramuscularly in the right arm on 17Dec2020 at 07:30 at a single dose for COVID-19 immunization; administered in a hospital. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Medical history included polycystic kidney disease from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. Concomitant medications included tolvaptan (JYNARQUE), lisinopril (MANUFACTURER UNKNOWN), amlodipine besilate (NORVASC); all taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of vaccination. On 17Dec2020 at 07:30, the patient experienced: joint pain in right shoulder causing issues with using my right arm as normal (medically significant). The adverse event resulted in a visit to a doctor or other healthcare professional office/clinic. Therapeutic measures were taken as a result of joint pain in right shoulder causing issues with using my right arm as normal; which included ongoing physical therapy. The patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140), intramuscularly in the left arm on 07Jan2021 at 07:30. The clinical outcome of the events was not recovered.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/17/2020,0.0,PVT,JYNARQUE; LISINOPRIL; NORVASC,,Medical History/Concurrent Conditions: Hypertension; Polycystic kidney,,,"['Arthralgia', 'Injected limb mobility decreased']",1,PFIZER\BIONTECH,OT 1021982,,,F,"Symptoms of a heart attack; allergic reaction to the first dose; The initial case was missing the following minimum criteria: unidentifiable reporter. Upon receipt of follow-up information on 27Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first Pfizer vaccine and had a terrible reaction and had to go to the ER. She had symptoms of a heart attack on an unspecified date. Her husband also had his and had no problems. She would highly recommend the vaccine if you do not have certain health issues. She's sensitive to many drugs. She called as she has a question. She received her first dose of the COVID-19 vaccine and she had an allergic reaction on an unspecified date and ended up in the ER. She asked if should she receive the second dose or not because she had an allergic reaction to the first dose. With the first shot, she ended up in the ER, that was just she had symptoms of heart attack and it was awful. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: The association between the event ""symptoms of heart attack"" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Cardiovascular symptom', 'Feeling abnormal', 'Hypersensitivity']",1,PFIZER\BIONTECH, 1021984,,,F,"tested positive for Covid-19 a week after the first dose of the vaccine; tested positive for Covid-19 a week after the first dose of the vaccine; This is a spontaneous report from a contactable Physician. A female patient of an unspecified age (reported as around 80 with no unit) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The caller was calling regarding a patient who tested positive for Covid-19 a week after the first dose of the vaccine. The reporter asked what the timing of the second dose was for someone who has active covid. The patient underwent lab tests and procedures which included Covid-19 test with a positive result. Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1021985,,,M,"Caller has a patient that received a covid-19 vaccine and then 3-4 days later was diagnosed with Covid; Caller has a patient that received a covid-19 vaccine and then 3-4 days later was diagnosed with Covid; This is a spontaneous report from a contactable physician. A 5-decade-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller has a patient that received a covid-19 vaccine and then 3-4 days later was diagnosed with Covid. Patient has made a full recovery and the caller would like to know what the guidance was for receiving the 2nd vaccine in series. The patient underwent lab tests and procedures which included COVID-19 virus test: diagnosed with Covid on an unspecified date. The outcome of events was recovered on an unspecified date. Information on the batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and drug ineffective due to temporal relationship. This case will be reassessed once additional information is available.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1021987,WI,81.0,M,"non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused; non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused; This is a spontaneous report from a contactable other health professional. An 81-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3249), intramuscular in left arm on 22Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included Parkinson's disease, post polio syndrome, Alzheimer's disease, atrial fibrillation, benign prostatic hyperplasia, right knee replacement, sleep apnoea, restless legs syndrome, covid-19 prior to vaccination. Concomitant medication included carbidopa monohydrate, levodopa (CARB/LEVO), cephalexin (unknown manufacturer), cetirizine (unknown manufacturer), citalopram (unknown manufacturer), donepezil (unknown manufacturer), etodolac (unknown manufacturer), finasteride (unknown manufacturer), furosemide (unknown manufacturer), metoprolol (unknown manufacturer), omeprazole (unknown manufacturer), oxybutynin (unknown manufacturer), senna alexandrina leaf (unknown manufacturer), tamsulosin (unknown manufacturer). The patient experienced had vaccine on friday and on sunday had neurological symptoms, non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused on 24Jan2021 14:00 with outcome of recovered in Jan2021. The patient was sent to ER and CVA/TIA were ruled out. Has no history of seizure disorder. Returned and had 1 more episode later in the day. Vitals were all within his normal limits. ER physician felt was possible reaction to vaccine. The patient was not treated due to the events. The patient had not been tested for COVID-19 since the vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/24/2021,2.0,SEN,CARB/LEVO; CEPHALEXIN; CETIRIZINE; CITALOPRAM; DONEPEZIL; ETODOLAC; FINASTERIDE; FUROSEMIDE; METOPROLOL; OMEPRAZOLE; OXYBUTYNIN; SENNA; TAMSULOSIN,,Medical History/Concurrent Conditions: Alzheimer's disease; Atrial fibrillation; BPH; COVID-19 (prior to vaccination); Knee replacement; Parkinson's disease; Post polio syndrome; Restless leg syndrome; Sleep apnea,,,"['Neurological symptom', 'Posture abnormal', 'Unresponsive to stimuli', 'Vision blurred']",1,PFIZER\BIONTECH,OT 1021993,IN,70.0,M,"Tachycardia 140- 125; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at 13:00 at single dose in left arm for COVID-19 immunisation at the age of 70-year-old. Lot number was EL1284. Medical history included myocardial infarction (MI), diabetic diet controlled, open heart surgery, cardiac stents, allergy. The patient experienced tachycardia 140-125 on 17Jan2021 at 06:00. The patient was not treated due to the event. The patient recovered from the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/17/2021,2.0,PVT,,,Medical History/Concurrent Conditions: Allergy; Coronary stent user; Diabetic diet; Myocardial infarction; Open heart surgery,,,['Tachycardia'],1,PFIZER\BIONTECH, 1021995,VT,57.0,F,"bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; This is a spontaneous report from a contactable physician. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3284), intramuscular into the left arm on 11Jan2021, at 16:00 as second single dose for covid-19 immunization. Medical history included Obstructive sleep apnea from an unknown date, oligodendroglioma from 1996 (noted as history of oligodendroglioma status post resection 25 years ago with stable follow up and no residual deficits). The patient had no known allergies to medications, food, supplements or herbal remedies. There were no concomitant medications; Patient was not taking any OTC medications, prescribed medications, supplements or herbal remedies at the time as well as in the period prior to her vaccinations. The patient previously received BNT162B2 (lot number EH9899 ) on 22Dec2020. On 18Jan2021, at 08:00, the patient experienced bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands, which was medically significant and had not recovered, as it was persisting. This was elaborated as follows: patient experienced one week following 2nd Pfizer covid-19 vaccine patient developed bilateral feet, left worse than right, burning, itching sensation. the symptoms progressed up to her mid calves and to a slight extent. The events were considered medically significant. Details were as follows: The symptoms were quite intense and interfered with her life, requiring gabapentin prescription for control of neuropathic complaints. Patient denied any significant weakness, low back pain, neck pain, balance problems, dizziness, bowel or bladder involvement. Patient saw physician who performed workup for common associated etiologies of polyneuropathy, which were negative. Patient underwent EMG/NCS which were normal, and subsequently skin bx (skin biopsy) to rule out small fiber neuropathy (results pending). The patient further described the incident as a week after receiving the second dose of the covid vaccine, the patient experienced new onset bilateral feet burning that went into her upper legs, mid calves and to a slight extent in both hands. The burning was experienced more in the left foot than the right foot. Reports it was severe enough for the patient to reach out to her primary care provider. (PCP) to start Gabapentin for neuropathic pain. PCP ordered labs to rule out infection and other causes for neuropathy which all came back negative. Patient has no known underlying risk factors that would predispose her to neuropathy. Neurologist did an EMG which showed no evidence of neuropathy. The patient went into to the office, and she had a skin biopsy to rule out small fiber neuropathy. She does not have results to provide for the skin biopsy at this time, however, the neurologist feels if the skin biopsy is positive, there may be an association with the vaccine in regards to the burning pain the patient is experiencing. She is calling to ask if this is a reported side effect. Treatment was confirmed as gabapentin was prescribed by PCP, and the patient started on it a few days after the onset of the burning pain. Outcome was noted as it has not improved, and has not resolved. No COVID tested post vaccination was noted. The outcome of the events was not recovered; the condition was persisting. Causality for the events was noted as related.; Sender's Comments: Based on a compatible temporal association contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the onset of events pruritus, burning sensation, condition aggravated cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/18/2021,7.0,PVT,,,Medical History/Concurrent Conditions: Obstructive sleep apnea syndrome; Oligodendroglioma (History of oligodendroglioma status post resection 25 years ago with stable follow up and no residual deficits.),,,"['Biopsy skin', 'Burning sensation', 'Electromyogram normal', 'Laboratory test', 'Loss of personal independence in daily activities', 'Nerve conduction studies normal', 'Neuralgia', 'Pruritus']",2,PFIZER\BIONTECH,OT 1021998,OH,86.0,F,"Numbness in face, legs; Slight headache; Whole chest froze up; It has been an effort to talk, she was really working hard to talk; Muscle tightness around her whole face; Legs weren't steady enough; Didn't feel well; She was very weak; Could only stay awake for very short amounts of time; She never had trouble with her stomach like this before; Lip has a slight droop on left side of her face; Felt like she was having a heart attack; Felt extreme exhaustion; Not able to eat; She thought she has low blood sugar; This is a spontaneous report from a contactable consumer (the patient). An 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiration date not reported), via an unspecified route of administration (left arm) on 21Jan2021 14:50 at a single dose for COVID-19 immunization. Medical history includes therapy on her back from the past, from an unknown date. Concomitant medication included melatonin to sleep and, paracetamol (TYLENOL) to sleep. The patient received the first dose of the vaccine on 21Jan2021 at around 2:50 PM, the next morning on 22Jan2021, she felt extreme exhaustion, she'd get up and have to get back to bed, not able to eat, and she thought she has low blood sugar. She got up and had a bowl of cereal. On an unspecified date, the patient also reported numbness in face, legs and slight headache, and need to eat all of a sudden or pass out, and these has gone on for five days now (at time of report). The patient also reported that her lip has a slight droop on left side of her face which was concerning her. The patient reported that after numbness and not eating, she had some ice cream and her whole chest froze up, and it felt like she was having a heart attack. Her chest felt like ice which never had happened before. It has been an effort to talk, she was really working hard to talk. The patient explained she got the vaccine 5 days ago (from the time of report) and reported she had muscle tightness around her whole face, she had a slight droop on the left lip, a slight headache right across the eye brows, her legs feel a little numb off and on, she got feeling of tiredness but that passes, she had the need to go eat suddenly or she will get very weak. The reason for the call was she was wondering if she should she go for the second vaccine when 5 days after having the vaccine she was experiencing numbness. Slight droop on the left lip started but never looked close until the time of report, not a lot but the lower lip on the left side it is slightly droopy, with slight headache right across the eye brows. Her legs felt a little numb off and on, and she stated that about 3 days after the vaccine, she was afraid to take a shower because her legs weren't steady enough. They are still that way at the time of report, but this did go away for a while on a day and she was able to take a shower. She also didn't feel well after the vaccine. On the day of the vaccine, she had a good dinner and felt good; but the next morning she was very weak and could only stay awake for very short amounts of time. She was in bed and couldn't stay up and this is not like her, she did not like to be in the bed. She got the feeling of tiredness but that passes and she can stay up for longer periods of time. She had to go eat or she gets very weak, she didn't feel like eating in the beginning. It was on the 4th day after the vaccine she would have to get a bowl of cereal all of a sudden or she would feel like she was going to pass out. She never had trouble with her stomach like this before where she felt the need to have to go and eat. She explained she never had trouble with stomach, she never had headaches, and never had a vaccine before. Muscle tightness around her whole face started 2 days after getting the vaccine and was getting worse. Her face felt really tight almost numb feeling. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/22/2021,1.0,UNK,MELATONIN; TYLENOL,,Medical History/Concurrent Conditions: Physical therapy,,,"['Abdominal discomfort', 'Aphasia', 'Asthenia', 'Blood glucose decreased', 'Chest discomfort', 'Decreased appetite', 'Dizziness', 'Dysphonia', 'Facial paralysis', 'Fatigue', 'Feeding disorder', 'Feeling cold', 'Gait disturbance', 'Headache', 'Hunger', 'Hypoaesthesia', 'Loss of consciousness', 'Malaise', 'Muscle tightness', 'Myocardial infarction']",1,PFIZER\BIONTECH, 1022002,IL,49.0,M,"tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer reporting for self. This 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 about noon at left deltoid (reported as left shoulder) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received his first dose on 07Jan2021. On 21Jan2021 he tested positive for COVID. He was scheduled to receive his second dose of the vaccine today (26Jan2021), and he wanted to know if he can get the second dose as scheduled or did he have to wait since he was still in quarantine. After informing doctor he had tested positive for COVID, he spoke with his doctor and recommended he take diphenhydramine hydrochloride (BENADRYL), Zyterec-D, and Nasal Spray. There were no additional vaccines administered on same date of BNT162B2, and there were no other vaccinations within 4 weeks. The event did not require a visit to emergency room or physician office. Lab data included height: either 5ft 8 inches or 5 ft 9 inches on unspecified date. The outcome of event was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/21/2021,14.0,SEN,,,,,,"['Body height', 'COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022005,NC,37.0,F,"dizziness; headache; tachycardia; chest pain; chills; fever; This is a spontaneous report from a contactable other healthcare professional (HCP). A 37-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982 and expiration date: unknown), intramuscular (right arm) on 24Jan2021 at 10:30 at a single dose for COVID-19 immunization. Medical history was not reported. Allergies to medications, food, or other products was unknown. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: unknown), on 03Jan2021 at 10:15AM, intramuscular (left arm) for COVID-19 immunization. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced dizziness, headache, tachycardia, chest pain, chills and fever on 25Jan2021. Treatment for the events included IV fluids, Benadryl, Antivert, Benadryl, Toradol and Reglan. The events required Emergency Room Visits and Physician Office Visit. The events were resolving at the time of the report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/25/2021,1.0,WRK,,,,,,"['COVID-19', 'Chest pain', 'Chills', 'Dizziness', 'Headache', 'Pyrexia', 'Tachycardia']",2,PFIZER\BIONTECH,OT 1022007,,,M,tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer reporting for himself. This male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date unknown) via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant drugs were not reported. The patient received the first dose of the vaccine on 08Jan2021 and then tested positive for COVID-19 on 14Jan2021. The patient wanted to know what he should do regarding receiving the second dose of the vaccine. The outcome of the event was unknown. Information about Lot/Batch number is requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/14/2021,6.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022009,,,F,"tested positive for covid-19 after administration of a PCR test; tested positive for covid-19 after administration of a PCR test; scratchy throat; she was really sick for two weeks; cough; This is a spontaneous report from a contactable consumer (patient). The female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 08Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. This female diabetes educator, who is also the patient, reports testing negative on a rapid test prior to receiving her first dose of the Pfizer covid-19 vaccine on 08Jan2021. On 09Jan2021, she experienced symptoms of covid-19 and then tested positive for covid-19 after administration of a PCR test. She does not feel getting covid-19 is related to receiving the covid-19 vaccine. She reports her covid-19 symptoms included scratchy throat, cough, and she was really sick for two weeks but now just has a little scratchy throat and cough still continuing. She is scheduled to receive her second dose of Pfizer covid-19 vaccine on 29Jan2021.the patient queried if she could get the second injection of Pfizer covid-19 vaccine when it is due since she got COVID-19 disease after the first injection or is that a contraindication. The outcome of the events was unknown. No follow-up attempts are possible, information on batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. While reporter causality is noted and it is very likely that the vaccine may not provide protection yet, further clinical information is needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/09/2021,1.0,UNK,,,,,,"['COVID-19', 'Cough', 'Drug ineffective', 'Illness', 'SARS-CoV-2 test', 'Throat irritation']",1,PFIZER\BIONTECH, 1022013,NY,68.0,F,"tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscularly at left arm on 15Jan2021 at single dose for COVID-19 vaccination. Medical history included her son having Covid-19. Concomitant medications were unknown. The patient received the covid vaccine on 15Jan2021 and since then she developed COVID-19 and tested positive in 2021. She believed this was related to her son having Covid-19. The patient didn't think she got the COVID from her shot, she thought she got it from her son who had it. She called to ask if it was okay if she received her second dose on 05Feb2021. The patient stated she already spoke with her doctor and he said it was okay as long as she was feeling better. Outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: The patient received the covid vaccine on 15Jan2021 and since then she developed COVID-19 and tested positive in 2021. Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. However, no complete effect of the suspect vaccine could be reasonably achieved from the first dose to protect from the targeted infection. Further information like COVID infection date needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,,,PVT,,,Medical History/Concurrent Conditions: Exposure to COVID-19,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1022014,,,F,"contract the virus; contract the virus; This is a spontaneous report from a contactable consumer reporting for herself via a Pfizer Sponsored Program. A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant drugs were not reported. The patient reported that she received the first dose and was scheduled to receive the second one in 3 weeks, and she usually got tested for the COVID-19 infection every 2 and a half weeks, and she stated ""actually I contract the virus"". The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1022015,IL,47.0,F,"her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; fever; her right carotid on her neck felt swollen; right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt; tired and achy; tired and achy; feeling sick; muscle and joint pain; muscle and joint pain; cough; the back of her ribs hurt; Nausea; she is having shooting pains in different spots; This is a spontaneous report from a contactable nurse reporting for self. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number EL3249, via an unspecified route of administration from 25Jan2021 14:00 (at the age of 47 years old), Dose 2, as a single dose in the left arm for COVID-19 immunization. Medical history included she had her tonsils out on an unknown date. She was a nurse that works with COVID patients; she got tested twice last week (Jan2021), both were negative. She had no pre-existing medical conditions. She has never had a problem with vaccines. There were no concomitant medications. The patient previously received dose 1 of BNT162B2 on 04Jan2021 (Lot # EX9231) and experienced no reaction then. The patient had the second dose of the Pfizer vaccine around 2 PM yesterday (25Jan2021) and she kept moving around in bed and feeling sick last night. That night she was just tired and achy but she thought that could just be from working. She went to bed early and she woke up around 1:50 or 2 AM with chills so she went and got a thermometer. She woke up at about 2 AM (26Jan2021) with a 103 fever and chills and her right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt. Her skin just burns; she went to take a shower. With the skin burning she knew it was sore to touch but when she got in the shower, that was when she noticed it hurt. She was really achy; her legs were aching and she was having shooting pains in different spots. She commented that she called out today (26Jan2021), she never calls out; all she wanted to do was take a shower and she wondered if she needed to go to the doctor. Her skin burns even when she was showering; every part her skin burns. She was also having muscle and joint pain and cough and the back of her ribs hurt (Jan2021). The other thing was nausea (Jan2021). The fever and chills were persisting and were about the same. She was hoping for it to go down so she could go to work to tomorrow (27Jan2021). The clinical outcome of the fever, chills, and her right carotid on her neck felt swollen and hurt was not recovered. The clinical outcome of feeling sick, tired and achy, face feels swollen, skin burning, muscle and joint pain, cough, back of her ribs hurt, nausea, and shooting pains in different spots was unknown. The reporter states she thinks what she is reporting was directly related to the product.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Tonsillectomy,,,"['Arthralgia', 'Chills', 'Cough', 'Fatigue', 'Impaired work ability', 'Malaise', 'Musculoskeletal chest pain', 'Myalgia', 'Nausea', 'Pain', 'Pain in extremity', 'Poor quality sleep', 'Pyrexia', 'SARS-CoV-2 test negative', 'Skin burning sensation', 'Swelling', 'Swelling face']",2,PFIZER\BIONTECH, 1022017,GA,34.0,M,"contracted COVID; contracted COVID; This is a spontaneous report received from a Pfizer sponsored program from a contactable Other-HCP (patient). A 34-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration in the left deltoid on 18Dec2020 at SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. He got the first dose of the COVID Vaccine on 18Dec2020. He then contracted COVID on 03Jan2021. The patient clarified that he started with symptoms on 03Jan2021. He tested negative for COVID on 04Jan2021 and then tested positive on 05Jan2021. He was supposed to get the second dose on 08Jan2021. He wanted to know how to proceed with receiving the second dose. Inquiring how long it will be effective. The outcome of the event was unknown.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,01/03/2021,16.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022019,TX,,M,"my O2 levels are dropping down to 80/ oxygen level is low; I am feeling blah; This is a spontaneous report from a contactable consumer. A 79 years-old male patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration, on 20Jan2021, as a single dose, for Covid-10 immunization. Medical history and concomitant medications were not reported. It was reported that the patient reported that it has been a week since getting the firs dose of the vaccine had he experienced O2 levels dropping down to 80, he got his first COVID shot. He was wondering how long was this going to last. He was 79, and he just feels kind of blah. His oxygen level is low. The clinical outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,,,UNK,,,,,,"['Feeling abnormal', 'Oxygen saturation decreased']",1,PFIZER\BIONTECH, 1022020,MN,54.0,F,"dry and reddened rash; the rash is so itchy and swollen; the rash is so itchy and swollen; This is a spontaneous report from a contactable Nurse. A 54-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL9261) vaccine , via an unspecified route of administration in the left shoulder on 18Jan2021 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient received the first dose of BNT162B2 vaccine on 28Dec2020. The patient experienced dry and reddened rash in the anterior side of her neck in the shape of her thyroid. on 22Jan2021 with outcome of not recovered , the rash is so itchy and swollen on 22Jan2021 with outcome of not recovered. The reported events were considered Important Medical Events. The patient used her son's eczema cream, clarified as ""Elcom"" or ""Elecom"" but the events worsened.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/22/2021,4.0,PVT,,,,,,"['Rash erythematous', 'Rash pruritic', 'Swelling']",2,PFIZER\BIONTECH, 1022021,,,U,"the same symptoms of COVID all over again; the same symptoms of COVID all over again; bad fever; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. The consumer reported same events for 2 patients. This is a first of two reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history included COVID-19 (not ongoing). Concomitant medications were not reported. The patient experienced symptoms of COVID-19 all over again and bad fever all on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date. The information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107798 Same reporter/product/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Body temperature', 'Drug ineffective', 'Pyrexia', 'SARS-CoV-2 test', 'Suspected COVID-19']",UNK,PFIZER\BIONTECH, 1022023,OR,58.0,F,"Right sensory neural hearing loss; Bilateral increased auditory fullness; Tinnitus; This is a spontaneous report from a contactable physician (patient herself). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL8982 and expiry date unknown) intramuscular at the left arm on 21Jan2021 15:00PM at a single dose for COVID-19 immunization. The patient's medical history included osteoarthritis and exercise-induced asthma, both from an unknown date and unknown if ongoing. Concomitant medications included celecoxib, paracetamol (TYLENOL), and Vitamin D (NOS); the patient received these medications within 2 weeks of vaccination. The patient is not pregnant at the time of vaccination. She received the first dose of BNT162B2 (lot number: EK9231, expiry date unknown) intramuscular at the left arm on 30Dec2020, 8:30AM at a single dose for COVID-19 immunization. The patient previously took metronidazole from an unknown date and had allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Five days after the second vaccine, on 26Jan2021, 6:00AM, the patient had a sudden onset of right sensory neural hearing loss. Leading up to the sudden loss of hearing, bilateral increased auditory fullness and tinnitus began one to two days after vaccine. The patient received intratympanic steroid injection as treatment for the adverse events. Outcome of the events was not recovered. The case report was assessed as Serious since the events were reported as disabling/incapacitating.; Sender's Comments: A contributory role of BNT162B2 to reported events cannot be fully excluded based on the temporal relationship. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/21/2021,01/01/2021,,PVT,CELECOXIB; TYLENOL; VITAMIN D NOS,,Medical History/Concurrent Conditions: Exercise induced asthma; Osteoarthritis,,,"['Auditory disorder', 'Deafness neurosensory', 'Deafness unilateral', 'Tinnitus']",2,PFIZER\BIONTECH,OT 1022024,,,F,"received Pfizer vaccine on 07Jan2021 tested positive on 26Jan2021 for covid; received Pfizer vaccine on 07Jan2021 tested positive on 26Jan2021 for covid; This is a spontaneous report from a contactable other health care professional (reported as nurse and NP). A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 07Jan2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. The reporter reported that patient received Pfizer vaccine on 07Jan2021 tested positive on 26Jan2021 for COVID. The reporter inquired the recommendations to get their second shot. Outcome of the event was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in this patient cannot be completely excluded. However, no complete effect of the suspect vaccine could be reasonably achieved from the first dose to protect from the targeted infection.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/26/2021,19.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-1 test']",1,PFIZER\BIONTECH, 1022025,PA,,U,"4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; 4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 4 patients, calling on behalf of another office. This report is for 1st of 4 patient. A patient of unspecified age and gender received the 1st and 2nd doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive for covid after receiving the 2nd dose over 15 days before this report/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test 15 days after receiving the whole series on an unspecified date. The patient had no Covid symptoms, feeling fine after both doses. The patient underwent lab tests and procedures which included Sars-cov-2 test (rapid antigen test kit): positive. The outcome of events was unknown. Reporter was wondering if it was a false positive. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101864 same reporter/drug/event, different patient;US-PFIZER INC-2021101866 same reporter/drug/event, different patient;US-PFIZER INC-2021101865 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Drug ineffective', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 1022027,FL,84.0,M,"felt weak; Dysentery; violently sick; throwing up; dehydrated; dry heaving; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: E18982, expiration date was not reported), intramuscular on the left arm (also reported as left shoulder) on 15Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. It was reported that the patient was taking an unspecified blood thinner and other unspecified products. It was reported that patient got the first dose on 15Jan2021 and everything was fine. The following Friday, exactly a week later, on 22Jan2021 at 930am he got violently sick as far as throwing up and dysentery. He was asking if it could be from the shot. He got sick and was heaving for 7 hours, then he was dry heaving after throwing up so much, it was green bile. He knew he was getting dehydrated and drank a bottle of Pedialyte at 7pm that night. He had to stay a half hour after getting the vaccine since they wanted to monitor him a little longer since he takes blood thinners an other crap. He did not specify the other medications that he takes. On Saturday he felt fine but he felt weak. The patient recovered from dysentery and throwing up on 23Jan2021, while outcome of the remaining events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/22/2021,7.0,UNK,,,,,,"['Anticoagulant therapy', 'Asthenia', 'Dehydration', 'Discoloured vomit', 'Dysentery', 'Illness', 'Retching', 'Vomiting']",1,PFIZER\BIONTECH,OT 1022028,HI,51.0,M,"got positive with Covid Virus; he tested positive for the COVID; sore throat; stuffiness; fatigue; This is a spontaneous report received from a Pfizer-sponsored program from a contactable consumer reported for himself. A 51-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration in the left arm on 16Jan2021 16:00 at SINGLE DOSE for covid-19 immunization. Medical history included ongoing Ulcerative colitis, ongoing Allergy and ""had close contact with someone who was positive"". Concomitant medication included ongoing mesalazine (taking for over 20 years) for Ulcerative colitis and ongoing allergy medicine (taking for two years, thinks it is Claritin grocery brand) for Allergy. Caller received first Pfizer vaccine on 16Jan2021. He was performed the nasal test at 11: 40 AM yesterday (25Jan2021) and received positive results for Covid 19 today (26Jan2021). Adds he had no symptoms after the vaccine. But he has sore throat, stuffiness, fatigue that started the 23Jan2021 with the COVID 19. All of these are getting better as of today (26Jan2021). The event did not require a visit to physician or ER. The patient stated ""I had close contact with someone who was positive."" He was supposed to receive his second vaccine dose on 06Feb2021. The patient stated ""they told me to quarantine for 10 days from the time I was exposed and that would be until 02Feb2021. Is there any reason I shouldn't get my 2nd dose?"" The outcome of the event COVID 19 was unknown, of other events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/23/2021,7.0,PVT,MESALAZINE,Allergy; Ulcerative colitis,Medical History/Concurrent Conditions: Exposure to SARS-CoV-2,,,"['COVID-19', 'Drug ineffective', 'Fatigue', 'Nasal congestion', 'Oropharyngeal pain', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022029,PA,50.0,F,"Bell's palsy on left side; soreness at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EV1685, expiry date unknown) via an unspecified route of administration on the left deltoid, left arm, on 05Jan2021 08:15 AM at a single dose for COVID-19 immunization. The patient's medical history included allergies to Penicillin and Sulfa from an unknown date and unknown if ongoing. The patient had no current Illness and no family medical history. The patient is not pregnant. Concomitant medications included metoprolol tartrate, Vitamin C [ascorbic acid], Vitamin D3, and Multivitamins; patient received these medications within two weeks prior to the COVID vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Patient had a routine Physical Examination on Nov2020 and underwent lab tests and procedures on 24Jan2021 which included unknown BW and negative Lyme Disease Test. On 23Jan2021 18:30, the patient developed bell's palsy on left side which was reported as getting a little worse every day. The event required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care; the event resulted in Disability or permanent damage. Since 24Jan2021, patient received Prednisone 60 mg, daily for 7days and Valtrex 1g, 3x/day (TID) for 7days as treatment for the event. The patient did not recover from the event Bell's palsy on left side.' It was further reported that patient experienced soreness at the injection site on an unspecified date with outcome of unknown.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event Facial paralysis cannot totally be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/05/2021,01/01/2021,,PVT,METOPROLOL TARTRATE; VITAMIN C [ASCORBIC ACID]; VITAMIN D3,,Medical History/Concurrent Conditions: Penicillin allergy; Sulfonamide allergy,,,"['Blood test', 'Borrelia test negative', 'Facial paralysis', 'Injection site pain']",1,PFIZER\BIONTECH, 1022030,FL,68.0,M,"tested positive for covid-19; tested positive for covid-19; he had a cold; Coughing; runny nose; congestion; This is a spontaneous report from a contactable consumer (Patient's wife). A 68-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246), intramuscular in Right arm on 07Jan2021 at 08:30-08:35 at single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient had symptoms and was tested positive for covid-19 on 22Jan2021 10:20. On 12Jan2021 04:00, the patient had coughing, runny nose, congestion and thought he had a cold. The patient was scheduled to have his second dose on 28Jan2021, and the reporter wanted to know if the patient should get it or not. The outcome of the event COVID-19 was unknown, of other events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/12/2021,5.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No,,,"['COVID-19', 'Cough', 'Drug ineffective', 'Nasal congestion', 'Nasopharyngitis', 'Rhinorrhoea', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1022034,,25.0,F,"tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable nurse who reported for herself. A 25-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on 22Jan2021 for Covid-19 immunization. The patient's concomitant medications were not reported. The patient got her first dose on 22Jan2021 and was tested positive for Covid that night due to close contact with a friend that had had a positive test. Her next vaccination date was after the 14 days quarantine but she was wondering if someone kept testing positive after that 14 day period, she knew some people test positive for months. She would like to know was it still safe to get the second dose. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. While the vaccine may not provide protection yet, further clinical information is needed for meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Exposure to COVID-19,,,"['Drug ineffective', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1022037,TN,50.0,F,"felt near syncopal; very short of breath; heart was pounding hard; felt tachycardic; BP was 160/100; irregular HR with PVCs; HR 40; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL1283) on 25Jan2021 08:15 given intramuscular (left arm) single dose for COVID-19 immunization. Medical history included was reported as none. The patient was not pregnant at the time of vaccination. Concomitant medication included estradiol, testosterone, lorazepam (ATIVAN). The patient previously received ultram/ Zofran ad experienced drug allergies, and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) on 04Jan2021 08:15 intramuscular single dose for COVID-19 immunization. The patient was not diagnosed with covid prior vaccination and the patient was not tested for covid post vaccination. On 25Jan2021 at 08:45 AM, 30 minutes after injection,-the patient felt horrible described as her heart was pounding hard and felt tachycardic. BP was 160/100 and HR 110 and felt near syncopal. Then PVCs started/ very short of breath, and HR went from 112, 69, 40, then 80. The patient went to ER. The patient was monitored and given was IVFs and O2, and labs checked. The patient was discharged 7 hours later and continued having irregular HR with PVCs. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on the available information, a possible contribution of the drug to the event syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,PVT,ESTRADIOL; TESTOSTERONE; ATIVAN,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Dyspnoea', 'Feeling abnormal', 'Heart rate irregular', 'Inappropriate schedule of product administration', 'Palpitations', 'Presyncope', 'Tachycardia', 'Ventricular extrasystoles']",2,PFIZER\BIONTECH,OT 1022039,FL,32.0,M,"Pericarditis after admit and negative ECHO, and CTA; Chest discomfort; initially thought it was heart burn lasted over 15 overs decided to visit ER.; Had elevated troponins was diagnosed with Pericarditis after admit and negative ECHO, and CTA; This is a spontaneous report from a contactable nurse (patient) reported that a 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the left arm on 14Jan2021 15:30 at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received influenza vaccine (FLU) on 10Dec2020 for immunization; and received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 24Dec2020 15:30 for Covid-19 immunization. On 16Jan2021 15:30, the patient experienced chest discomfort, initially thought it was heart burn lasted over 15 ""overs"" decided to visit ER. The patient had elevated troponins, and was diagnosed with Pericarditis after admit and negative ECHO, and CTA. As treatment, patient received IV Toradol. The reported events resulted hospitalization for 1 day. The patient underwent lab tests and procedures which included angiogram (CTA): negative, echocardiogram (ECHO): negative, troponin: elevated; all on 16Jan2021. The outcome of the events was recovering.; Sender's Comments: Based on the vaccine's safety profile, the event pericarditis and the associated symptoms are more likely intercurrent condition, unrelated to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/14/2021,01/16/2021,2.0,PVT,,,Medical History/Concurrent Conditions: High cholesterol,,,"['Angiogram', 'Chest discomfort', 'Dyspepsia', 'Echocardiogram normal', 'Pericarditis', 'Troponin increased']",2,PFIZER\BIONTECH, 1022043,NC,71.0,F,"Afib; Felt dizzy; heart racing; elevated BP; This is a spontaneous report from a contactable pharmacist. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration at the right arm on 23Jan2021 at 13:30 (01:30 PM) at single dose for COVID-19 immunization, administered in workplace clinic. The patient is not pregnant. The patient's medical history included atrial fibrillation (Afib), hypertension, thyroid cancer, and lymphoma. It was unknown if the patient has known allergies. Concomitant medications (other medications in two weeks) included multiple prescription medications (unspecified). It was unknown if the patient had other vaccines in four weeks. It was unknown if the patient had COVID prior to vaccination. The patient felt dizzy, heart racing, elevated BP (blood pressure), and Afib on 23Jan2021 at 13:30 (01:30 PM), described as: Felt dizzy and ""heart racing"", elevated BP (blood pressure) noted with Afib on monitor. Patient felt symptoms at 15 minutes with periods of Afib and normal sinus on the monitor. Vitals and ongoing monitoring taken. The patient verbalized history of chronic Afib. No other symptoms and no distress noted otherwise. The patient and her family declined ER treatment or further medical evaluation. The patient did not receive treatment for the events. It was unknown if the patient was tested for COVID post vaccination. The outcome of the events was recovered on Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/23/2021,0.0,OTH,,,"Medical History/Concurrent Conditions: AFib (Other medical history: Afib, hypertension, Thyroid cancer, Lymphoma; chronic Afib); Hypertension (Other medical history: Afib, hypertension, Thyroid cancer, Lymphoma); Lymphoma (Other medical history: Afib, hypertension, Thyroid cancer, Lymphoma); Thyroid cancer (Other medical history: Afib, hypertension, Thyroid cancer, Lymphoma)",,,"['Atrial fibrillation', 'Blood pressure increased', 'Cardiac monitoring abnormal', 'Condition aggravated', 'Dizziness', 'Palpitations']",1,PFIZER\BIONTECH, 1022044,,,U,"A person gets the first dose of the COVID-19 vaccine and within 5-7 days gets COVID-19; A person gets the first dose of the COVID-19 vaccine and within 5-7 days gets COVID-19; This is a spontaneous report from a contactable physician. This physician reported for a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the first dose of the covid-19 vaccine and within 5-7 days got covid-19 on an unspecified date with outcome of unknown. Information about batch/lot number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), and within 5-7 days got COVID-19. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the COVID 19 likely represents a pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1022045,FL,,F,"She tested positive for Covid19; She tested positive for Covid19; This is a spontaneous report from a contactable consumer. A 32-year-old female patient (reporter's daughter) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for covid19 on 21Jan2021. The patient wanted to know can the patient get a 2nd vaccine if they are positive or will she have to start with dose 1 again. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/21/2021,16.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022046,,,M,"tested positive for Covid since the first dose; tested positive for Covid since the first dose; This is a spontaneous report from a contactable consumer. This consumer reported for himself that the male patient of unknown age who received first dose of bnt162b2 (Pfizer-Biontech covid-19 vaccine), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. Medical history and concomitant medications were unknown. States he is due to get his second dose on 02Feb2021 but he has tested positive for Covid since the first dose (Jan2021) and wants to know what to do. The outcome of the events was unknown. Information about Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022047,WA,62.0,F,"collapse and passed out; Woke up at midnight with severe leg cramps; I turned white as a ghost and sweats; I turned white as a ghost and sweats; Got the chills after sweating; This is a spontaneous report from a contactable 62-year-old female consumer reported for herself that she received 1st dose of bnt162b2 (BNT162B2; lot number EL9261) on 26Jan2021 04:30 PM at left arm for COVID-19 immunization in Public Health Clinic. Medical history and concomitant drugs was none. The patient woke up at midnight with severe leg cramps, tried walking it out, collapse and passed out (according to husband). He stated that the patient turned white as a ghost and sweats. After coming too, drank electrolytes and water. The patient got the chills after sweating. It took a while for her to warm up and go back to sleep. Event start time was reported as 27Jan2021. The outcome of the event was resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/27/2021,1.0,PUB,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Hyperhidrosis', 'Loss of consciousness', 'Muscle spasms', 'Pallor', 'Sleep disorder', 'Syncope']",1,PFIZER\BIONTECH, 1022049,NY,,M,"diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable consumer. This consumer reported for self that the male patient of unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. On 10Jan2021 the patient developed symptoms and was diagnosed with COVID-19 (unrelated to vaccine obviously). He was fully recovered as of 26Jan2021. He was scheduled for the second doze of vaccine for 28Jan2021. The outcome of the events was recovered. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/10/2021,3.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022050,,,F,"COVID-19 infection/Covid-19 positive; COVID-19 infection/Covid-19 positive; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient received her first dose on 12Jan2021. She developed COVID-19 infection two weeks after receiving the vaccine in Jan2021. The lab data included Covid-19 positive in Jan2021. The outcome was unknown. Information about batch/lot number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1022051,WI,57.0,F,"dizziness; jittery; shaky; headache; fluid in her ears; wake up in the middle of the night; Weakness; chills; tired; This is a spontaneous report from a contactable registered nurse (patient). A 57-year-old female nurse received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) injection at single dose via an unknown route in the left deltoid on 20Jan2021 for Covid-19 immunization. Medical history included hypothyroidism. Concomitant drug included ongoing levothyroxine sodium (EUTHYROX) started about 12 years ago as of 27Jan2021 at 75mcg once a day for hypothyroidism. Patient had first dose on the 20Jan2021, Wednesday and the last two nights (as of 27Jan2021) patient had chills. Onset date of chills was 25Jan2021. She assumed it would be sooner than further out close to the second one getting side effects. She also experienced weakness and was really really tired. Onset date of tired was 24Jan2021. She was unsure if she should get the second dose, or if she needs to contact her provider about this. She did not know if these are normal side effects or not. She looked at the side effect list, which said chills and headache, which she has experienced both. She also had dizziness. She used Flonase for the fluid in her ears. She thought the headache and dizziness was from fluid from pressure or something. The FLONASE helped with that. She had no fever. She was a week out from getting the dose and was wondering if she should still be having these side effects. Headache/ dizziness and weakness started a few days after she got the vaccine. She thought the weakness started that Friday or Saturday. If she got enough sleep she was okay, but she would wake up in the middle of the night. She thought the chills were from the weakness. She was also jittery and shaky as part of the weakness. Patient was always being really really tired later in the day. She thought that if she were working full time she would be missing work and that was medically significant. Treatment included FLONASE and took paracetamol (TYLENOL) for the headache early on. The events (chills, weakness, tired, headache and dizziness) were reported as serious with seriousness criteria of other medically important condition. No Investigation Assessment performed. Outcome of the events chills, weakness, tired was not resolved. Outcome of headache and dizziness was resolved. Outcome of the other evens was unknown.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/24/2021,4.0,UNK,EUTHYROX,,Medical History/Concurrent Conditions: Hypothyroidism,,,"['Asthenia', 'Chills', 'Dizziness', 'Fatigue', 'Feeling jittery', 'Headache', 'Insomnia', 'Middle ear effusion', 'Sleep disorder', 'Tremor']",1,PFIZER\BIONTECH, 1022052,WA,,M,"Upon awakening the day after receiving the vaccination, he was incoherent and having hallucinations much more pronounced than previously observed; Upon awakening the day after receiving the vaccination, he was incoherent and having hallucinations much more pronounced than previously observed; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL9261), via an unspecified route of administration on 25Jan2021 16:00 at Left arm at single dose for covid-19 immunization. Vaccine was administered in hospital. Medical history included Parkinson's with dementia. There has been some history of hallucination. None known allergies. Concomitant medication included carbidopa monohydrate, levodopa (CARBIDOPA + LEVODOPA), galantamine, memantine and others. No other vaccine in four weeks. No COVID prior vaccination and COVID was not tested post vaccination. Upon awakening the day after receiving the vaccination, he was incoherent and had hallucinations which were much more pronounced than previously observed. This lasted for about 3 hours and he slowly returned to his baseline status on 26Jan2021. The outcome of the events was recovered on 26Jan2021. No treatment received.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/26/2021,1.0,PVT,CARBIDOPA + LEVODOPA; GALANTAMINE; MEMANTINE,,Medical History/Concurrent Conditions: Dementia due to Parkinson's disease; Hallucination,,,"['Condition aggravated', 'Hallucination', 'Incoherent']",1,PFIZER\BIONTECH, 1022053,MD,34.0,F,"right sided facial paralysis; headache/migraine from base of R skull radiating to R Ear and top of head; This is a spontaneous report from a contactable nurse. This 34-Year-Old female nurse (patient) received 2nd dose of BNT162B2 (lot number=EL3247) Intramuscular on 21Jan2021 00: 00 AM (reported as 20Jan2021 12:00 PM) on Right arm for covid-19 immunization. Medical history and concomitant drug were not reported. Past drug was Known allergies to doxycycline. Historical Vaccine was 1st dose of BNT162B2 (lot number=EL1284, on 31Dec2020, 12:15 PM, administrator route=Intramuscular, vaccine location=Right arm). No other vaccine in four weeks. Patient received vaccine on Wednesday 20Jan2021, went to ER on Sunday 24Jan2021 with right sided facial paralysis and headache/migraine from base of R skull radiating to R Ear and top of head from 23Jan2021 10:00 AM with outcome was Recovering. Treatment was medications prednisone and antiviral. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts possible. No further information expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of facial paralysis due to temporal relationship and current drug safety profile. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/23/2021,2.0,PVT,,,,,,"['Facial paralysis', 'Headache', 'Hemiplegia', 'Migraine', 'Pain']",2,PFIZER\BIONTECH,OT 1022054,WI,,F,"bloody diarrhea; I thought like I was dying; felt a shooting pain across the chest and then went to above my left eye; felt a shooting pain across the chest and then went to above my left eye; It felt like a migraine; felt like a piercing pain on the back and side of my head; felt like a piercing pain on the back and side of my head; felt a numbness on my left arm and hand; It felt weird and I couldn't describe it, more like I felt with pressure and heaviness; It felt weird and I couldn't describe it, more like I felt with pressure and heaviness; I also felt bloating and severe cramping; I also felt bloating and severe cramping/severe abdominal cramping; tired/fatigue, major fatigue; weak; short of breath; diarrhea; I had burning in my stomach; nausea; This is a spontaneous report from a contactable Nurse (patient) reported for self. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: EL0142, via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received the 1st dose on 11Jan2021 and she felt normal and had no underlying conditions. After the shot she instantaneously felt a shooting pain across the chest and then went to above her left eye. It felt like a migraine and felt like a piercing pain on the back and side of her head hours later and was intermittent for a couple of days. It became an intermittent headache for 2 weeks. She also instantaneously within a few minutes felt a numbness on her left arm and hand. It felt weird and she couldn't describe it, more like she felt with pressure and heaviness which lasted for 2 days. Later that night she also felt bloating and severe cramping that was so severe she couldn't walk for 4 days and come and go intermittently. She was rolling over her bed in pain. She was so tired, weak, and short of breath she couldn't do anything. She also had about 10 episodes of diarrhea with 3 of them being bloody diarrhea over the weekend, the last episode of bloody diarrhea was on the 18th, after which her stool was clear, normal looking. She couldn't eat anything because of this. No one in her facility that she knew of had similar side effects as her. She was terrified and very very afraid. She was also frustrated because she was not sure if it was the vaccine or not. This week she was just starting to get back to normal and feel better. She consulted with HCPs and did tests like Complete blood count, stool sample, abdominal X-ray, and COVID tests that all came back normal. She was still on the fence on whether or not she could get the 2nd dose because she came in there normal and came back like heck afterward. Patient stated she was a little concerned about whether or not she should get the second vaccine based on the symptoms she had from the first one. Patient further stated the first time she had the shot, she experienced the side effects. It started off with shooting pain across her chest and then pain in her head and then she had bloatedness with a little bit of nausea and then she had burning in her stomach. Patient stated, actually, she had more bloatedness in the stomach, more than nausea it was more like she was very bloated and that lasted for about two weeks. And she also had pain, as soon as she gave her injection, she had pain all across her chest and then she had a instant headache. She also ended up having bloody diarrhea. She had several tests afterwards from her doctor to figure out other possible causes, they did culture and they took her lab and they did an membrane X-ray of her abdomen and everything came back normal and fine and she felt totally fine until she had the shot and then all of a sudden everything fell apart and she felt terrible for two weeks. She had severe abdominal cramping, She thought like she was dying and fatigue, major fatigue. But she had one more question, she was wondering if anyone else has had similar experiences after this vaccine. Patient wanted to know if she should get the second vaccine. After receiving the first Covid vaccine she experienced pain across her chest and severe pain on left side of head. She wondered if the vaccinator had hit a nerve when injecting the vaccine. She then began to experience bloating, cramping, bloody diarrhea and severe fatigue, which lasted for about 2 weeks. She underwent testing by having stool samples and X-rays, but all tests came back negative. About treatment, patient stated, yes and she also have severe abdominal cramping. The outcome of the events was unknown. The reporting nurse (patient) considered the events Shooting pain across my chest, Headache, Bloatedness; I had more bloatedness in the stomach; Burning in my stomach, Nausea, Bloody diarrhea, Severe abdominal cramping, Fatigue, were related to COVID-19 vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/01/2021,,UNK,,,,,,"['Abdominal X-ray', 'Abdominal distension', 'Asthenia', 'Chest pain', 'Diarrhoea', 'Diarrhoea haemorrhagic', 'Dizziness', 'Dyspepsia', 'Dyspnoea', 'Emotional distress', 'Eye pain', 'Fatigue', 'Fear', 'Feeding disorder', 'Feeling abnormal', 'Frustration tolerance decreased', 'Full blood count normal', 'Gait inability', 'Headache', 'Hypoaesthesia', 'Immediate post-injection reaction', 'Limb discomfort', 'Loss of personal independence in daily activities', 'Migraine', 'Muscle spasms', 'Nausea', 'Pain', 'SARS-CoV-2 test negative', 'Stool analysis normal']",1,PFIZER\BIONTECH, 1022055,FL,74.0,M,"Had a mild a heart attack and mild stroke; had a mild a heart attack and mild stroke; urinary tract infection; Blood infection; A1C was 6.5; there was a little blood in his urine; he fell out of bed and couldn't get up; he was flushed; he had a fever of 101; This is a spontaneous report from a contactable consumer (patient's wife). A 74-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL1283) at 0.3 mL single on 20Jan2021 for COVID-19 immunization. Medical history included thyroid; hypertension, was under control with the medication; dementia, taking memantine as a treatment for dementia, no other impairment other than what he normally has from his dementia. Concomitant medications included levothyroxine; memantine for dementia; fish oil tablet; Vitamins. Patient had a mild heart attack and a slight stroke and he did have urinary tract and blood infection on 24Jan2021. They both had the first dose of the Pfizer covid vaccine on 20Jan2021, Saturday night into Sunday. He was a dementia patient, alert to his name. On 24Jan2021, he fell out of bed and couldn't get up, he was flushed, so patient's wife took his temperature, he had a fever of 101. Patient's wife couldn't move him, so called the paramedics and they took him to Hospital. Patient's wife just found out that he had a very mild heart attack and slight stroke, no impairment other than what he normally had from the dementia. Patient's wife was wondering should he get the second shot and what was the timing of the 2nd dose of vaccine. Reporter seriousness for mild heart attack, slight stroke, urinary tract and blood infection was hospitalization. They also have him on some sort of penicillin derivative for a urinary tract infection. Since he had been to the hospital, he had at his doctor's office about 2 weeks ago today, he had a blood test, a urine test. His A1C was 6.5, there was a little blood in his urine. For that since Sunday (24Jan2021) he was having MRI, he had a couple of PET scans, he had an electrocardiogram. The neurologist came in to check on him. He was in hospital now. Hospitalization date was 25Jan2021 early in the morning. The outcome of events was unknown.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/20/2021,01/24/2021,4.0,PVT,LEVOTHYROXINE; MEMANTINE; FISH OIL,,Medical History/Concurrent Conditions: Dementia; Hypertension; Thyroid disorder,,,"['Blood test', 'Blood urine present', 'Cerebrovascular accident', 'Dysstasia', 'Electrocardiogram', 'Fall', 'Flushing', 'Glycosylated haemoglobin increased', 'Magnetic resonance imaging', 'Mobility decreased', 'Myocardial infarction', 'Positron emission tomogram', 'Pyrexia', 'Sepsis', 'Urinary tract infection', 'Urine analysis abnormal']",1,PFIZER\BIONTECH, 1022056,NY,71.0,M,"his face was feeling funny/his face was paralyzed on the left side/ Bell's Palsy; Pain at the injection site; This is a spontaneous report from a contactable consumer (patient's wife). A 71-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3248), via an unspecified route of administration on 24Jan2021 12:30 at single dose in right arm for COVID-19 immunization. Medical history included Diabetes, Blood pressure high, High cholesterol, Enlarged prostate. Concomitant medications taken within two weeks before the event onset included irbesartan, verapamil, metformin, topiramate, omeprazole, tamsulosin, clonazepam, simvastatin, acetylsalicylic acid (BABY ASPIRIN), all were ongoing. Vaccination facility type was Hospital. The patient received the Pfizer covid vaccine first dose on Sunday 24Jan2021, On Monday (25Jan2021) afternoon, his face was feeling funny, by the time he got home, his face was paralyzed on the left side. The injection site was on his right arm. The reporter called paramedics and he went to the Emergency Room, and was diagnosed with Bell's Palsy. No history prior to vaccination. All his tests were negative in the hospital, EKG, CT, all tests negative in Jan2021. wasn't a stroke or anything like that. One doctor said it could be related to the vaccine and the other said he didn't know. The reporter wanted to know if he could go back for the second dose, if one dose could provide any protection. Consumer calling about the Pfizer COVID-19 vaccine (later referred to as just shot or COVID shot by caller) for her husband, and says the reason why she called was her husband got Bell's Palsy from it, and she didn't know if he should still go for a second shot. She said his face was all paralyzed right now, he got the COVID-19 shot on Sunday, then Monday night he went to the ER and was diagnosed with Bell's Palsy, all tests were clear that it was not a stroke and had to be from the shot. The patient's face was feeling funny, and when he got home his face was paralyzed and she called 911. She said he was admitted from the ER overnight on Monday night (25Jan2021), then she picked him up on Tuesday night. She said he was diagnosed with Bell's Palsy, and they gave him medication, which was Prednisone and patches to keep his eye closed, and another med called Valacyclovir, which was an antiviral medication, and some eyedrops. She said his vaccine card just says first dose, patient number, (City and State name), and has a date on the back for his second shot which was scheduled for 14Feb2021. Treatment Valacyclovir: Caller says that this was in a (Pharmacy name) bottle and that label told instructions to take it and said no refills, discard after 26Jan2022, it was a week's worth of pills. Prednisone 10mg. Caller said this was also in a pharmacy bottle that said take 5, then 4, then 3, then 2, then 1. The label said discard after 26Jan2022. She said that the eyedrops were over the counter lubricant eye drops for his left eye. Caller said the patient took a medication for electrical activity in the brain, so they did a MRI and a CAT scan and they all came back negative on the tests, and his heart tests came back negative (Jan2021). No further details provided about electrical brain activity medication or test results. Caller said that the doctors sent her husband home and said it was Bell's Palsy, likely a result of the vaccine, that there was nothing wrong with him, they can't say for sure, they said it could be coincidental. She said they probably can't say it was the vaccine that gave it to him, some doctors said yes during the stay at the hospital and some said they couldn't say. She said that there were quite a few doctors there, it is a big hospital, that worked in the stroke unit. Caller said that she would like to know if there were any product recommendations about whether her husband should get the second dose. It further reported that on 25Jan2021 at Lunch time his face felt funny and by 17:00 left side of face was paralyzed. He was treated in the ER of (Hospital name and Address). as if he had signs of stroke. Reporter seriousness for Bell's palsy was Hospitalization. The dates when patient was in hospital for Bell's palsy was from 25Jan2021 to Unspecified date. Reporter stated patient also experienced pain at the injection site in Jan2021. MRI, EEG, EKG and Sonogram, all clear and All negative in Jan2021. The outcome of the event ""his face was feeling funny/his face was paralyzed on the left side/ Bell's Palsy"" was not recovered, of the other event was unknown.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/24/2021,01/01/2021,,PVT,IRBESARTAN; VERAPAMIL; METFORMIN; TOPIRAMATE; OMEPRAZOLE; TAMSULOSIN; CLONAZEPAM; SIMVASTATIN; BABY ASPIRIN,,Medical History/Concurrent Conditions: Blood pressure high; Diabetes; Enlarged prostate; High cholesterol,,,"['Computerised tomogram normal', 'Electrocardiogram normal', 'Electroencephalogram normal', 'Facial discomfort', 'Facial paralysis', 'Feeling abnormal', 'Injection site pain', 'Magnetic resonance imaging normal', 'Ultrasound scan normal']",1,PFIZER\BIONTECH, 1022057,,,M,"Covid-19 with symptoms starting on 21Jan2021 and positive test on 22Jan2021; Covid-19 with symptoms starting on 21Jan2021 and positive test on 22Jan2021; This is a spontaneous report from a contactable pharmacist reporting for himself. A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 12Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 with symptoms starting on 21Jan2021 and positive test on 22Jan2021 (medically significant) with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 22Jan2021. The information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE due to temporal relationship. However, based on the mechanism of action of the vaccine, it appears unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022059,FL,,F,"her mother also went positive for Covid; Positive for covid; This is a spontaneous report from a contactable consumer, mother of the patient. A 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unknown date at single dose for COVID-19 immunization. The patient had not medical history. Concomitant medications were not reported. The patient went positive for covid. The outcome of the event was unknown. The reporter mentioned that her mother has no prior health conditions and her physician recommended to receive the second dose regardless she had covid or not. Information on lot/batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022060,CA,49.0,F,"but she tested positive for COVID-19; but she tested positive for COVID-19/ COVID symptoms/fever; This is a spontaneous report from a contactable nurse (patient) and a nurse. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at left arm, at single dose for covid-19 immunization. Medical history was none. There were no concomitant medications. The patient was supposed to receive the second dose of the vaccine on 25Jan2021. She tested positive for COVID on 17Jan2021. Also reported that she tested positive for COVID-19 on 19Jan2021, she did have some COVID symptoms, she was better now, she treated them by she kept herself at home. She said a fever was all she had, for two days, she drank a lot of water. She spoke to her supervisor who told her she could delay her second dose up to 40 days after the first dose. She would like to know if this is true. She also needed advice because she didn't know what to do since she already got the first vaccine dose. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event tested positive for COVID-19 based on the known safety profile. However the short duration of 5 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/17/2021,13.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022061,,,M,"developed symptoms and was tested positive for covid-19 infection; developed symptoms and was tested positive for covid-19 infection; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient developed symptoms and was tested positive for covid-19 infection on 25Jan2021 with outcome of unknown. He was receiving monoclonal antibodies today (27Jan2021). The patient underwent lab tests included covid-19 virus test: positive on 25Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/25/2021,3.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022062,MI,70.0,F,"shingles; Pain; This is a spontaneous report from a contactable consumer (patient husband). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9261) via unspecified route on arm single dose for COVID-19 immunization on 21Jan2021, about 15:00, at 70-year-old. Medical history included: diagnosed allergies, compromised immune status, endocrine abnormalities, genetic / chromosomal abnormalities, respiratory illness, diabetes, obesity. The patient had a whole list of concomitant product medications (unspecified). The patient came down with shingles four and a half hours after the vaccine (21Jan2021, about 19:00 - 19:30), emergency room visited. They noticed a rash on her back which got worse, so she was taken to the hospital on 26Jan2021 and was diagnosed with shingles. She's still in the hospital but has gotten better. She was currently hospitalized for the shingles and related pain on 26Jan2021 that was more than she could handle. The patient had a few blood tests; urinalysis; a lot of sugar testing; and negative on the COVID test prior to them admitting her to the hospital. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/21/2021,01/21/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Allergy; Chromosomal anomalies; Diabetes; Endocrine disorder; Immune imbalance; Obesity; Respiratory disorder,,,"['Blood glucose', 'Blood test', 'Herpes zoster', 'Pain', 'Rash', 'SARS-CoV-2 test negative', 'Urine analysis']",UNK,PFIZER\BIONTECH, 1022064,WV,,F,"Guillain-Barre; sometimes I feel a shooting or sharp pain in the muscle; tingling in my leg (right); progressed to pain in leg muscle/ then pain in back and arms too; then pain in back and arms too; headache; nausea; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. The female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 25Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included muscle pain in legs and anxiety. The patient's concomitant medications were not reported. Caller received 1st dose on Monday, approximately 11 am. Caller says, ""later in the day"" experienced a headache. On Tuesday caller woke up (approx. 4 am) with ""tingling in my leg (right)"", ""progressed to pain in leg muscle. ""then pain in back and arms too"" on 26Jan2021. Caller says that ""taking Advil helps a little"". ""sometimes I feel a shooting or sharp pain in the muscle (usually in arms)"". Today, caller experience, "" a little jab in the arm muscles"". Caller says she was worried she was ""getting Guillain-Barre"". Caller mentions that she has experienced muscle pain in legs in the past. Caller states, ""I was never diagnosed with Fibromyalgia"". Caller says she does have history of anxiety. Caller says, ""sometimes I feel a little spacey, but I feel like that before, that's nothing new"". Caller also says, ""I think I might have had nausea the first day (after vaccine)."" The outcome of the events was unknown. No follow-up attempts are possible, information on batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/25/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Anxiety; Muscle pain,,,"['Anxiety', 'Back pain', 'Feeling abnormal', 'Headache', 'Myalgia', 'Pain', 'Pain in extremity', 'Paraesthesia']",1,PFIZER\BIONTECH, 1022065,MI,27.0,F,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number EL1283) via an unspecified route of administration on left arm on 11Jan2021 15:45 at a single dose for covid-19 immunization. The patient usually has migraines. The patient's concomitant medications were reported none. The patient received the first dose Covid-19 vaccine on 11Jan2021. On 18Jan2021 she started showing symptoms. She tested positive for Covid on 20Jan2021. The health department said she can come off of quarantine on Friday, 29Jan2021. She is scheduled her second dose 01Feb2021. Should she get the vaccine or should she put to off since she tested positive. The symptoms she experienced were cough, difficulty breathing, headache. She also had nausea, sinus congestions, loss of taste and sense of smell and full body fatigue. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/18/2021,7.0,UNK,,,Medical History/Concurrent Conditions: Migraine,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022066,OR,71.0,M,"Contrast head CT scan showed a lacunar infarct in the M1 region from MCA; Bell's Palsy; This is a spontaneous report from a contactable physician reporting for himself. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL2437), intramuscularly on 13Jan2021 11:00 on right arm at single dose for COVID-19 immunization. Vaccination facility type was at Clinic. Medical history included Myocardial infarction from 2019, Prostate cancer from 2016 which biochemical reoccurrence caused his PSA to bump up, Subclinical hypothyroidism, prevention of coronary artery disease, prevent platelet aggregation, urgency incontenece, asthma symptoms, High Blood Pressure from 2009 and ongoing, Aortic insufficiency from 2008 and ongoing. Ongoing concomitant medications included Carvedilol from 2011 for high blood pressure, rosuvastatin from 2015 for prevention of coronary artery disease, acetylsalicylic acid (ASPIRIN) from 2019 for prevent platelet aggregation, tamsulosin from Dec2020 for urgency incontenece, levothyroxine from 2011 for Subclinical hypothyroidism, montelukast from 2011 for asthma symptoms. The caller stated that he was a physician and emeritus professor. He received the Pfizer-BioNTech COVID-19 vaccine 2 weeks ago and developed Bell's Palsy on 24Jan2021 after receiving this first dose. He had already reported this reaction but he would like to know if there was any safety information on receiving the second dose after this type of adverse reaction. Patient had ""mentioned"" the reaction to his HCP but he had not spoken with her about specific guidance on whether or not to receive the second dose. Patient wished there was a way he could see more information regarding patients who have reported Bell's Palsy as a reaction to the mRNA COVID-19 vaccine to see if it could be a trend related to mRNA in the vaccines or if it was statistically insignificant. Patient visited the Emergency Room on 25Jan2021. Patient had a Contrast head CT scan on 25Jan2021. The results were read by the radiologist. The neuro radiologist also read the results and made a revision. He had two different reports, it showed a lacunar infarct in the M1 region from MCA. Not causing facial paralysis. There was no defined cause of the paralysis. Patient was asking if we have a resource on the significance of Bell's Palsy following a vaccine. He was scheduled to have the booster on 04Feb2021 and needed to know what to do. Treatment was received for the events included Prednisone and Acyclovir. The outcome of the events were not resolved. Follow-up attempts are completed. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported Bell's Palsy and lacunar infarct, and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/24/2021,11.0,PUB,CARVEDILOL; ROSUVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]; TAMSULOSIN; LEVOTHYROXINE; MONTELUKAST,Aortic regurgitation; Blood pressure high,Medical History/Concurrent Conditions: Asthma; Coronary artery disease; Myocardial infarction; Platelet aggregation abnormal; Prostate cancer (biochemical reoccurrence caused his PSA to bump up); Subclinical hypothyroidism; Urinary incontinence,,,"['Adverse reaction', 'Computerised tomogram head abnormal', 'Facial paralysis', 'Lacunar infarction', 'Scan with contrast']",1,PFIZER\BIONTECH,OT 1022067,GA,69.0,F,"2 days after vaccine developed weakness of legs then arms. MRI cervical and thoracic spine most consistent with Transverse Myelitis; Transverse Myelitis; This is a spontaneous report from a contactable physician. A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 at single dose for COVID-19 immunisation. The patient was not pregnant at Time of Vaccination. Facility type vaccine was Hospital. Medical history included hyperlipidemia, hypothyroid. The patient's concomitant medications were not reported. No Other vaccine in 4weeks. Days after vaccine on 22Jan20212, the patient developed weakness of legs then arms. MRI cervical and thoracic spine most consistent with Transverse Myelitis. AEs resulted in Hospitalization, Disability or permanent damage. The patient was recovering. IV steroids, physical therapy was received as Treatment. No covid prior vaccination. No covid tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Yes,N,01/20/2021,01/01/2021,,PVT,,,Medical History/Concurrent Conditions: Hyperlipidemia; Hypothyroidism,,,"['Magnetic resonance imaging neck', 'Magnetic resonance imaging spinal abnormal', 'Magnetic resonance imaging thoracic abnormal', 'Muscular weakness', 'Myelitis transverse']",UNK,PFIZER\BIONTECH, 1022068,OR,62.0,M,"Cornea transplant rejection; inflammation/subepithelial infilatrates noted 1 week after the first vaccine; This is a spontaneous report from a contactable Physician (patient). A 62-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EK9231, via an unspecified route of administration on 28Dec2020 14:30 at single dose in Left arm for COVID-19 immunization, vaccinated in Hospital. Medical history included diabetes; Graft is 2.5 years old. Partial thickness transplant (deep anterior lamellar keratoplasty) for treatment of keratoconus. The patient didn't have COVID prior vaccination. Concomitant medications included trazodone, rosuvastatin calcium (CRESTOR), zolpidem tartrate (AMBIEN), gabapentin, metformin. The were no other vaccines in four weeks. The patient previously took buspar and experienced drug allergy. The patient experienced cornea transplant rejection. Signs of inflammation noted one week after vaccine on 04Jan2021 02:00 PM. Subepithelial infilatrates noted 1 week after the first vaccine. Resolved with Pred Forte. The patient didn't have COVID test post vaccination. The outcome of the events was recovered. The temporal relationship with the COVID vaccine was reconstructed by the patient afterwards after thinking about it in retrospect.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,PVT,TRAZODONE; CRESTOR; AMBIEN; GABAPENTIN; METFORMIN,,"Medical History/Concurrent Conditions: Diabetes; Keratoconus; Keratoplasty (for treatment of keratoconus, Graft is 2.5 years old)",,,"['Corneal infiltrates', 'Inflammation']",1,PFIZER\BIONTECH, 1022069,,,M,"he could barely eat breakfast, nausea, sleepy, sweating, lethargic, and after seeing his HCP his blood work says he has liver inflammation; He is unable to walk now without a walker; This is a spontaneous report from a non-contactable consumer (patient's wife). A 72 years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received vaccine on 19Jan2021. After he got home, he could barely eat breakfast, nausea, sleepy, sweating, lethargic on 19Jan2021 and after seeing his HCP his blood work says he had liver inflammation. He was unable to walk now without a walker in Jan2021. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,01/01/2021,,UNK,,,,,,"['Blood test abnormal', 'Feeding disorder', 'Gait inability', 'Hepatitis', 'Hyperhidrosis', 'Lethargy', 'Nausea', 'Somnolence', 'Walking aid user']",UNK,PFIZER\BIONTECH, 1022070,CA,68.0,F,"arm soreness; community acquired pneumonia; COPD; shortness of breath; chest congestion; weakness; fatigue; Muscle aches and pains; she became ill; This is a spontaneous report from a contactable nurse from a Pfizer-sponsored program Pfizer First Connect. A 68-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on 06Jan2021 at single dose on right deltoid for covid-19 immunisation. Medical history included blood pressure high and seasonal allergies. There were no concomitant medications. The patient previously received first dose of bnt162b2 (Lot: EJ1685) on 16Dec2020 for COVID-19 immunization. The patient experienced community acquired pneumonia, shortness of breath, chest congestion, weakness, fatigue, COPD, muscle aches and pains, she became ill, all on12Jan2021; arm soreness on an unspecified date. Events required Emergency Room visit. Clinical course reported as: she got the second dose of the pfizer covid vaccine on 06Jan2021 and on 12Jan2021 she experienced shortness of breath, chest congestion, weakness and fatigue. Nurse stated ER doctor thought she had COPD or community acquired pneumonia. Nurse further stated she had the second COVID-19 vaccine on 06Jan2021. A week later on 12Jan2021, she became ill. She had all the symptoms of COVID. She was short of breath, very fatigued. She couldn't get any air, she was at work. She had muscle aches and pains. The shortness of breath, fatigue and weakness lasted several days. She also had severe chest congestion. She confirmed she got better. It actually took 4 or 5 days. By that Sunday (17Jan2021) she was better. She wanted it noted she had no reaction right after the shot. She stated she only had arm soreness, it was just a little sore, not even worth mentioning. It was only when she moved her arm a certain way. This was with either vaccine (first or second vaccine). She went to the doctor and somebody thought it might be a reaction, but the nurse thought it was too late for a reaction. The ER doctor thought it was COPD and community acquired pneumonia. Her primary doctor thought it was COPD. The patient underwent lab tests and procedures which included COVID-19 test: negative on 12Jan2021. Outcome of arm soreness was unknown, others was recovering.; Sender's Comments: Based on the drug-event time interval and the vaccine's safety profile, the community acquired pneumonia is possibly intercurrent condition, unrelated to vaccine BNT162B2 administration, which is not the disease that the vaccine BNT162B2 can prevent from. While the COPD is more likely underlying condition, unrelated to vaccine BNT162 injection. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/12/2021,6.0,PVT,,,Medical History/Concurrent Conditions: Allergy; Blood pressure high,,,"['Asthenia', 'Chronic obstructive pulmonary disease', 'Dyspnoea', 'Fatigue', 'Illness', 'Malaise', 'Myalgia', 'Pain', 'Pain in extremity', 'Pneumonia', 'Pulmonary congestion', 'Respiratory tract congestion', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,OT 1022071,FL,82.0,M,"hearing is off/his ears feel like they're full of water so he can't really hear; lost his voice; dizziness/Really dizzy; bottom of the feet is tingling; Slightly blurry vision; This is a spontaneous report from a contactable consumer (caregiver). An 82-years-old male patient (Father) received first dose of BNT162B2 (BNT162B2, lot number: EL1283), via an unspecified route of administration in left arm on 24Jan2021 13:30 at SINGLE DOSE as Scared to death to get COVID. Medical history included ongoing High blood pressure. Family history included Father died of melanoma. Concomitant medication included ongoing lisinopril (strength: 10mg) for High blood pressure. Caller stated her father received the pfizer covid vaccine first dose on this Monday and have weird side effects, he lost his voice, dizziness/ Really dizzy, hearing is off/ Ears feel like they're full of water so he can't really hear, bottom of the feet is tingling/ tingling in his feet and slightly blurry vision. Caller wanted to know if it is normal. Caller also said safety department told her to speak to quality department about the shot her farther received is it a bad batch or not. No visit to Emergency Room and Physician Office. The outcome of the events was not recovered. No follow-up attempts possible. No further information expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/01/2021,,PVT,LISINOPRIL,Blood pressure high,Medical History/Concurrent Conditions: Melanoma (Father died of melanoma),,,"['Aphonia', 'Dizziness', 'Ear discomfort', 'Feeling abnormal', 'Hypoacusis', 'Paraesthesia', 'Vision blurred']",1,PFIZER\BIONTECH, 1022073,GA,57.0,F,"Blood pressure was also a little elevated on 22Jan2021, 196/106/ 179/101 on 27Jan2021; severe left facial swelling; facial abscess; This is a spontaneous report from a contactable health care professional (nurse practitioner). A 57-Year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unknown date in Jan2021 for Covid-19 immunization. Medical history included hypertension diagnosed for years as of 27Jan2021, and dental cleaning (also reported unsure if it was after or before vaccine). Concomitant drug was reported as ""none"". She not sure of the exact date of administration, stated patient came in to the office to be seen on Friday morning, 22Jan2021. Patient told caller at that time that she had the vaccine last week as of 27Jan2021, was seen for severe left facial swelling, onset of symptom was on Wednesday 20Jan2021. She was treated for facial abscess with Clindamycin 300mg 4 x a day for 10 days, she took first dose of treatment on Friday 22Jan2021. She followed up with doctor on 27Jan2021 and was improved, about 75%better. Her Blood pressure was also a little elevated on 22Jan2021 visit, it was 196/106 and on 27Jan2021 it was 179/101, did not know if this related to vaccine or symptoms. Patient reported that she went to dentist and had cleaning, unknown exact date of cleaning, unsure if it was after or before vaccine. She stated that doctor thought the symptoms could be due to dental cleaning not the vaccine. Patient went to ENT on Monday 25Jan2021 and they cleared her of anything ENT related from her neck up; scoped her and looked at her sinuses, and everything was fine. The ENT doctors told the patient that it appeared to be a reaction to the vaccine and advised her not to get the second dose. The reporter inquired whether patient should get the second dose. No Investigation Assessment was performed. The event severe left facial swelling was reported as serious with seriousness criteria of other medically important condition. Outcome of the event severe left facial swelling and facial abscess was resolving. Outcome of the other event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the outcome of treatment, the reported events severe left facial swelling, facial abscess, and elevated BP are likely intercurrent medical conditions and are unrelated to suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Dental cleaning (also reported unsure if it was after or before vaccine); Hypertension (diagnosed for years),,,"['Ear, nose and throat examination normal', 'Hypertension', 'Subcutaneous abscess', 'Swelling face']",1,PFIZER\BIONTECH, 1022074,MO,48.0,M,"Approximately 24 hours after vaccination I began to get a headache; A few hours later I began to get nauseous; began to vomit; My body started to ache; adrenal crisis; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231) via an unknown route of administration in right arm on 22Jan2021 15:30 at single dose for COVID-19 immunization. Medical history included Type 1 Diabetic, Addison's Disease, Graves Disease, Large B Cell Lymphoma (Remission). Concomitant medications included insulin aspart (NOVOLOG), prednisone. Approximately 24 hours after vaccination he began to get a headache on 23Jan2021 15:30. A few hours later he began to get nauseous and began to vomit, his body started to ache while also throwing his body into an adrenal crisis, on 23Jan2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 3 days. Stress dose steroids were received as treatment and also multiply blood tests were done in Jan2021. No other vaccine in four weeks. No Covid prior vaccination. Covid tested post vaccination: Nasal Swab with result of negative on 23Jan2021. The outcome of the events was recovered in Jan2021.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/22/2021,01/23/2021,1.0,PVT,NOVOLOG; PREDNISONE,,Medical History/Concurrent Conditions: Addison's disease; Graves' disease; Lymphoma; Type 1 diabetes mellitus,,,"['Adrenocortical insufficiency acute', 'Blood test', 'Headache', 'Nausea', 'Pain', 'SARS-CoV-2 test', 'Vomiting']",1,PFIZER\BIONTECH, 1022076,,85.0,M,"unresponsiveness for 2 minutes in seated position; bilateral arm tremor; pallor; eyes rolled back; drooling; nausea; vomiting; This is a spontaneous report from a non-contactable pharmacist. An 85-years-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), intramuscular on 27Jan2021 10:30 AM at single dose on Left arm for covid-19. Medical history included anaphylaxis history of unknown cause. The patient's concomitant medications were not reported. 30 minutes into observation, patient experienced bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness for 2 minutes in seated position on 27Jan2021 11:00 AM. 911 called immediately. Patient became alert and oriented after 2 minutes but experienced nausea and vomiting on 27Jan2021 11:00 AM. While seated, vital signs were taken- BP 148/76, HR 73, O2 98% on 27Jan2021. No falls or medication administered. (name withheld) arrived around 11:10 am and assessed cardiac rhythm and vital signs. Patient initially wanted to go home, but based on (name withheld) assessment, recommendation was to go to the ER. No treatment received. Outcome of events was recovered on 27Jan2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to the events bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness is possible. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Anaphylaxis,,,"['Drooling', 'Eye movement disorder', 'Nausea', 'Pallor', 'Tremor', 'Unresponsive to stimuli', 'Vomiting']",1,PFIZER\BIONTECH,OT 1022079,,,F,"chest congestion; consisting of headache; sore throat; fever; shortness of breath; diarrhea; facial pain; burning sinuses; now she was weak; This is a spontaneous report based on the information received by Pfizer from Allergan (Manufacturer Report Number: AGN255108). A contactable consumer reported that a 6-decade-old female patient (not pregnant)received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took Botox for 8-10 years for Cervical Dystonia and in the beginning she had torticollis. The Botox straightened out her torticollis, which caused unspecified allergies for which she took Allegra-D. Her last Botox treatment was in Oct2020. She was past due for Botox due to having to take the Covid-19 vaccine. The patient got a Covid-19 vaccine on 20Jan2021. On 21Jan2021 she began having a ""reaction"" to the vaccine, consisting of headache, sore throat, fever, chest congestion, shortness of breath, diarrhea, facial pain, and burning sinuses. It took 24 hours after the vaccine to show symptoms, events began 21Jan2021. The symptoms were ongoing and now she was weak, and was unsure how long she will be at work today. There had been no treatment for the symptoms. The outcome of the events were not resolved. Information on lot number/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/21/2021,1.0,UNK,,,,,,"['Asthenia', 'Burning sensation', 'Diarrhoea', 'Dyspnoea', 'Facial pain', 'Headache', 'Oropharyngeal pain', 'Pulmonary congestion', 'Pyrexia', 'Respiratory tract congestion', 'Sinus pain']",UNK,PFIZER\BIONTECH, 1022082,,,F,"between the time she was covid positive; between the time she was covid positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported a female patient of an unspecified age received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number not known) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient said she got her first dose and between the time she was covid positive she said that she is scheduled to have the second dose this Thursday the 28Jan. Caller was asking if she could get the second dose even though she is a covid positive she said that she will be out of quarantine today (26Jan2021). The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022083,OR,62.0,M,"evidence of endothelial inflammation and anterior chamber cells and KP on endothelium; evidence of endothelial inflammation and anterior chamber cells and KP on endothelium; evidence of endothelial inflammation and anterior chamber cells and KP on endothelium; This is a spontaneous report from a contactable physician. A 62-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunisation. Medical history included diabetes and graft was 2.5 years old, partial thickness transplant (deep anterior lamellar keratoplasty) for treatment of keratoconus. Concomitant medication included trazodone, rosuvastatin calcium (CRESTOR), zolpidem tartrate (AMBIEN), gabapentin, metformin. No COVID prior vaccination. Known allergies: Buspar. The patient previously received first dose of bnt162b2 on 28Dec2020 for COVID-19 immunization and experienced Cornea transplant rejection and inflammation/subepithelial infilatrates noted 1 week after the first vaccine. No other vaccine in four weeks. The patient experienced after 2nd vaccine, evidence of endothelial inflammation and anterior chamber cells and KP on endothelium. Clinical course reported as: Cornea transplant rejection. Graft was 2.5 years old. Partial thickness transplant (deep anterior lamellar keratoplasty) for treatment of keratoconus. Signs of inflammation noted one week after each vaccine. Subepithelial infilatrates noted 1 week after the first vaccine. Resolved with Pred Forte. However, after 2nd vaccine, evidence of endothelial inflammation and anterior chamber cells and KP on endothelium noted on follow-up examination. Placed on stronger topical steroid with Durezol. Patient asymptomatic during entire process and this was found on routine follow-up exam and not because patient noted any symptoms. Vision not affected. Outcome of events was recovering. The doctor's office appointment was a routine appointment unrelated to receiving the vaccine. The temporal relationship with the COVID vaccine was reconstructed by the patient afterwards after thinking about it in retrospect. No COVID tested post vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,,,PVT,TRAZODONE; CRESTOR; AMBIEN; GABAPENTIN; METFORMIN,,"Medical History/Concurrent Conditions: Diabetes; Keratoconus (graft was 2.5 years old, partial thickness transplant (deep anterior lamellar keratoplasty) for treatment of keratoconus); Keratoplasty (graft was 2.5 years old, partial thickness transplant (deep anterior lamellar keratoplasty) for treatment of keratoconus)",,,"['Corneal graft rejection', 'Corneal opacity', 'Inflammation', 'Keratitis']",2,PFIZER\BIONTECH, 1022085,,,F,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable Pharmacist reported for a female patient (Wife) of unknown age that received first dose of bnt162b2 (Covid-19 Vaccine), via an unspecified route of administration at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. Pharmacist said wife had 1st dose of covid vaccine 3 weeks ago, then tested positive for covid virus. Has fever and slight cough. Wondering if she can get 2nd dose of covid vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association, the COVID-19 infection is possible due to lack of efficacy of suspect vaccine BNT62B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022086,IN,72.0,F,"Within 24 hours of the injection my atrial fibrillation reoccurred; This is a spontaneous report from a contactable consumer. A 72-year-old female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9262), via an unknown route, on 23Jan2021 (at 13:15) at a single dose on the left arm for COVID-19 immunisation, administered at hospital. Relevant medical history included high cholesterol, high blood pressure and atrial fibrillation (she had been treated for Afib in the past but had been off of all medications for many months). Relevant concomitant medications included atorvastatin for high cholesterol and metoprolol for high blood pressure. No other vaccine was received in four weeks. Within 24 hours of the injection, on 24Jan2021 at 13:30, atrial fibrillation reoccurred. Physician office visit was done. Therapeutic measures taken as result of the event included apixaban (ELIQUIS) and dofetilide. An electrocardiogram (EKG) was done and results were unknown. Post-vaccination COVID test was not performed. The patient had recovered from the event in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/24/2021,1.0,PVT,ATORVASTATIN; METOPROLOL,,"Medical History/Concurrent Conditions: Atrial fibrillation (I have been treated for Afib in the past, but had been off of all medications for many months); Blood pressure high; High cholesterol",,,"['Atrial fibrillation', 'Condition aggravated', 'Electrocardiogram']",1,PFIZER\BIONTECH, 1022088,,,U,"2 patients received first dose of the Covid-19 Vaccine and then contracted Covid-19.; 2 patients received first dose of the Covid-19 Vaccine and then contracted Covid-19.; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. This consumer reported similar events for two patients. This is first of two reports. A patient of unspecified age and gender received first dose Covid-19 Vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history includes patients were exposed to the virus. The patient's concomitant medications were not reported. The patient received first dose of the covid-19 vaccine and then contracted covid-19. Caller stated it is not an AE since her patients were exposed to the virus. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021085847 Same reporter/ drug/ event for different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Exposure to COVID-19,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1022089,,,U,"2 patients received first dose of the Covid-19 Vaccine and then contracted Covid-19.; 2 patients received first dose of the Covid-19 Vaccine and then contracted Covid-19.; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. This consumer reported similar events for two patients. This is 2nd of two reports. A patient of unspecified age and gender received the first dose of Covid-19 Vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for covid-19 immunization. The patient medical history includes patients were exposed to the virus. The patient's concomitant medications were not reported. The patient received first dose of the covid-19 vaccine and then contracted covid-19. Caller stated it is not an AE since her patients were exposed to the virus. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021085846 Same reporter/ drug/ event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Exposure to COVID-19,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1022090,FL,,M,"Caller tested positive after the first shot/COVID; Caller tested positive after the first shot/COVID; He had a little bit of a cough but thought it was allergies; He had chills and sensitive skin; He had chills and sensitive skin; This is a Spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported a male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient said he was fortunate to have received the Pfizer COVID Vaccine. He was retired Navy. He received the dose at Hospital on 22Jan2021. Apparently at that time he had initial symptoms of COVID. He had a little bit of a cough but thought it was allergies. After the vaccine, the next few days his symptoms developed. His cough got worse. He had chills and sensitive skin. On 25Jan2021 he was tested for COVID. He got his results this morning and they were positive. He has been talking with online nurses and doctors. He has specific questions for Pfizer. Patient wanted to know about could the shot itself have contributed to a positive test from forming antibodies. Second dose was scheduled for 12Feb2021. Wanted to know if he should get that one. He pulled his back coughing too hard. He was headed to the Emergency Room (ER) to get treated because he cannot go anywhere else due to COVID. The outcome of the events was unknown with treatment received. Information on the batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/01/2021,,PVT,,,,,,"['COVID-19', 'Chills', 'Cough', 'Drug ineffective', 'SARS-CoV-2 antibody test', 'Sensitive skin']",1,PFIZER\BIONTECH, 1022091,TX,37.0,F,"tested positive for Covid; tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse (patient) reported that a 37 years old female patient received 2nd dose of BNT162B2 (Batch/lot number: EL1283/EH9899, Expiry Date: Mar2021) on 08Jan2021 at single dose on Left Deltoid, upper left arm for Covid-19 immunization. Medical history and concomitant drug were not reported. It was reported that patient received both doses of Covid vaccine and tested positive for Covid day 18 post second dose. She received the second dose on 08Jan2021. However, she tested positive for COVID-19 on 24Jan2021. She wanted to know if she will be an asymptomatic carrier in the future. Outcome of the event was unknown. No follow-up attempts possible. No further information expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/24/2021,,OTH,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022093,WV,,M,"diabetic wounds; end stage heart failure; He tested positive for COVID; He tested positive for COVID; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received first dose of bnt162b2 (reported as COVID-19 vaccine), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received his first dose of the COVID-19 vaccine on 07Jan2021. He tested positive for COVID on 27Jan2021. Patient was in hospice care. He went to the hospital for treatment of diabetic wounds on 20Jan2021. In addition to diabetes he had end stage heart failure on an unspecified date. Event took place after use of product. The event outcome was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/07/2021,01/27/2021,20.0,UNK,,,,,,"['COVID-19', 'Cardiac failure chronic', 'Diabetic wound', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1022094,MO,,U,"tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and fender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 22Jan2021 for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received their Pfizer vaccine on 22Jan2021. The patient then tested positive for COVID on Monday, 25Jan2021. The patient was to receive a monoclonal antibody infusion, bamlanivimab. Patient had to wait 90 days to get the Pfizer vaccine. Pharmacist asked after that 90 days was up, should the patient get the second dose, or start the series over. The outcome of events was unknown. Information about lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/25/2021,3.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022097,FL,,U,"tested positive after taking the first dose of the vaccine; tested positive after taking the first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A patient of unspecified age and gender received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient tested positive after taking the first dose of the vaccine. Outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Drug ineffective', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1022098,CA,,U,"positive for COVID 6 days post first dose/Sore throat/body aches; positive for COVID 6 days post first dose/sore throat/body aches; This is a spontaneous report from a contactable nurse. This report was received via a Pfizer Sales Representative. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date (reported as a Thursday) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first shot on a Thursday. 5 days later patient was exposed to a COVID patient. Patient got tested for COVID-19 and tested positive for COVID 6 days post first dose. Day 7 post dose experienced sore throat and body aches. Events took place after use of product. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and drug ineffective due to temporal relationship. This case will be reassessed once additional information is available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022099,PA,63.0,F,"Contracted Covid on 18Jan; Contracted Covid on 18Jan; Nasal congestion; Fever; Headache; Body aches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself that a 63 years old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL0142 and Expiration Date 31Mar2021) via an unspecified route of administration on 14Jan2021 around 8:30am-8:45am (vaccine location: left upper arm) at single dose for COVID-19 immunisation. The patient's ongoing medical history included compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, Allergic to sulfa when she was a child, seasonal allergies, graves disease in 2014, which was been in remission for the last few years. Other medical history included high cholesterol. Family history included Her mother has Type II Diabetes; she has some unknown cancers in her family; no further information to provide. There was none other prior vaccinations (within 4 weeks). The concomitant medications were reported as ongoing atorvastatin at 40mg taken once daily for High cholesterol (Taken for a long time, at least 10 years).The day after she got the Pfizer COVID- 19 Vaccine she was around someone who had traveled who she did not realize had not quarantined and had seen relatives who were positive for COVID. Patient was contracted Covid on 18Jan2021 (possibly overnight while sleeping or early morning) and had Mild symptoms. First started with nasal congestion; then developed fever; headache; and body aches. Events has improved, she has gotten much better; just been having a fever on and off and nasal congestion but getting better every day; still just having a little bit of symptoms. She was diagnosed with COVID after that administration. She is not saying the vaccine gave her COVID. She called to ask if she should still get the second dose of Pfizer COVID-19 Vaccine as scheduled for 04Feb2021 with this diagnosis. Rapid COVID test (nasal swab) on 21Jan2021 and Positive for COVID. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/18/2021,4.0,PVT,ATORVASTATIN,Chromosomal abnormality NOS; Diabetes; Endocrine disorder; Graves' disease (in remission); Immune system disorder; Obesity; Respiratory disorder; Seasonal allergy; Sulfonamide allergy (when she was a child),Medical History/Concurrent Conditions: Cancer (in her family); High cholesterol; Type II diabetes mellitus (Her mother),,,"['COVID-19', 'Drug ineffective', 'Headache', 'Nasal congestion', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1022100,IL,,M,"First covid-19 vaccine dose 2 weeks ago, tested positive for covid-19; First covid-19 vaccine dose 2 weeks ago, tested positive for covid-19; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient received first covid-19 vaccine dose 2 weeks ago(Jan2021), tested positive for covid-19 on 21Jan2021, he was questioning if he should have the second dose of covid-19 today as scheduled. The patient underwent lab tests and procedures, which included tested positive for covid-19 on 21Jan2021. The outcome of the events was unknown. Information on the Lot/Batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/21/2021,20.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022101,AZ,,F,"Grandma was tested positive 11 days after the first dose; Grandma was tested positive 11 days after the first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient (reporter's grandmother) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was tested positive 11 days after the first dose. Grandmother had an appointment for 2nd dose on 30Jan2021 and tested positive after 1st dose. He said his grandmother had a test again on an unknown date but this time she's negative for Covid-19. The outcome of the events was recovered on an unknown date. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022105,,,U,Patient received 1st dose of covid vaccine Friday. Monday patient had tested positive Monday.; Patient received 1st dose of covid vaccine Friday. Monday patient had tested positive Monday.; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A patient of an unspecified age and gender received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received 1st dose of covid vaccine on Friday. Monday patient had tested positive. Called would like to know if and when patient can get 2 dose of covid vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022106,SC,70.0,F,"Her sister was diagnosed with covid today 27Jan2021/Positive with covid after the first dose; Positive with covid after the first dose; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable nurse (patient's sister). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on unknown date in Jan2021 at single dose on right arm for preventative. Medical history and concomitant medications were not reported. Reporter's sister had gotten COVID in between the two vaccine doses. She clarified that her sister only had the first dose of the vaccine. Her sister was diagnosed with COVID today 27Jan2021. Lab data included SARS-CoV-2 test positive on 27Jan2021. Her sister will be done with quarantine the day before she gets her second dose. She was calling to ask if her sister can get the second dose. She read all the information and she thought it should be ok for her sister to get the second dose. Outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/27/2021,26.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1022107,,33.0,F,"Pregnant at the time of vaccination: Yes; She is pregnant at time of vaccination; She is pregnant at time of vaccination; first, covid 19; first, covid 19; This is a spontaneous report from a non-contactable consumer A 33-year-old pregnant female patient received bnt162b2 (BNT162B2; Solution for injection) via an unspecified route of administration on 31Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had last menstrual on 31Jan2021. She is pregnant at time of vaccination while taking bnt162b2. On an unknown date in 2021, patient had first, covid 19. The mother was due to deliver on 07Nov2021. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. There was no treatment for the event covid 19. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/31/2021,01/31/2021,0.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'Exposure during pregnancy', 'Off label use', 'Product use issue']",UNK,PFIZER\BIONTECH, 1022108,CA,,F,"covid positive; covid positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable female consumer (patient) of an unspecified age reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was covid positive on 12Jan2021 with outcome of unknown. The patient underwent lab tests included covid-19 virus test: positive on 12Jan2021. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/12/2021,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022110,,,F,"positive for the COVID-19 Virus; positive for the COVID-19 Virus; This is a spontaneous report from a contactable consumer. This consumer reported for self that the female patient of unknown age received first dose of bnt162b2 (Covid-19 Vaccine), via an unspecified route of administration at single dose for covid-19 immunisation. Medical history included congestion. Concomitant medications were unknown. She said she didn't realize she was asymptomatic, and tested positive for the COVID-19 Virus. She said she had already received her first COVID-19 Vaccine dose before she was told she was positive for the COVID-19 Virus. Consumer asked if she should delay getting the second dose of the COVID-19 Vaccine, or does she need to start from scratch. She asked if Pfizer has any specific COVID-19 Vaccine protocol for someone who has tested positive for the COVID-19 Virus after already receiving a COVID-19 Vaccine dose. Reported she had been experiencing some congestion, so she decided on a Monday to get tested for the COVID-19 Virus. She said her COVID-19 Virus test was negative. She said on that Friday she was still congested. She said she had her first COVID-19 Vaccine dose earlier on that Friday. She said after she had received the COVID-19 Vaccine on that Friday, someone who she had been in close contact with tested positive for the COVID-19 Virus. She said since her congestion started, she had developed other symptoms, so she retested for the COVID-19 Virus later in the day that Friday. She said she received a positive COVID-19 Virus test result on Monday. She said she was guessing that the was positive for the COVID-19 Virus at the time she received her first COVID-19 Vaccine dose on that Friday. Reported she looked at Pfizer's Medical Information website to see if she needed to repeat her first COVID-19 Vaccine dose, and didn't find any information directly related to her situation. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number could not be requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022111,PA,,U,"tested positive for Covid/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; 4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 4 patients, calling on behalf of another office. This report is for 2nd of 4 patient. A patient of unspecified age and gender received the 1st and 2nd doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has tested positive for covid after receiving the 2nd dose over 15 days before this report/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test 15 days after receiving the whole series on an unspecified date. The patient had no Covid symptoms, feeling fine after both doses. The patient underwent lab tests and procedures which included Sars-cov-2 test (rapid antigen test kit): positive. The outcome of events was unknown. Reporter was wondering if it was a false positive. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076785 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Drug ineffective', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 1022112,PA,,U,"tested positive for Covid/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; tested positive for Covid/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 4 patients, calling on behalf of another office. This report is for 3rd of 4 patient. A patient of unspecified age and gender received the 1st and 2nd doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive for Covid after receiving the 2nd dose over 15 days before this report/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test 15 days after receiving the whole series on an unspecified date. The patient had no Covid symptoms, feeling fine after both doses. The patient underwent lab tests and procedures which included Sars-cov-2 test (rapid antigen test kit): positive. The outcome of events was unknown. Reporter was wondering if it was a false positive. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076785 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Drug ineffective', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 1022114,FL,69.0,F,"Tested positive for COVID; Tested positive for COVID; Lost taste and smell; Lost taste and smell; cold like symptoms; Fever; chills; nausea; vomiting; felt cold; runny nose; This is a spontaneous report from a contactable consumer (patient). This 69-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via intramuscularly at left arm on 07Jan2021 at single dose for prevention. Medical history included allergic to Penicillin, quite a bit of discomfort with two shingles shots, exposed to COVID-19. Concomitant medications were none. The patient experienced cold like symptoms, Fever, chills, nausea, vomiting, felt cold, runny nose, all on 17Jan2021 10:00; lost taste and smell on 21Jan2021; tested positive for COVID on 22Jan2021 10:20. The patient received the first inoculation 07Jan2021, she had symptoms. The patient was tested for COVID on 22Jan2021 and both tested positive. The patient was scheduled to have their second dose on 28Jan2021, and she wanted to know if she should get it or not. She did not feel it was a result of the vaccination. She felt it was because she got exposed to COVID-19. Her symptoms were more severe on that one day. She felt like she was getting a cold that day. She was a compassionate care giver for her mother and wanted to get tested before they went to see her in a facility. She was surprised when she got a positive result. She still had a cough, runny nose and cold like symptoms. Her loss of taste and smell started about 4-5 days ago. Outcome of the event tested positive for COVID was unknown, of the event Lost taste and smell was not recovered, of other events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/17/2021,10.0,PUB,,,Medical History/Concurrent Conditions: Discomfort; Exposure to SARS-CoV-2; Penicillin allergy,,,"['Ageusia', 'Anosmia', 'COVID-19', 'Chills', 'Drug ineffective', 'Feeling cold', 'Nasopharyngitis', 'Nausea', 'Pyrexia', 'Rhinorrhoea', 'SARS-CoV-2 test', 'Vomiting']",1,PFIZER\BIONTECH,OT 1022119,MO,34.0,F,"Fever; Headache; Chills; Feeling like a heavy weight on her body; Back pain; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EZ3247), via an unspecified route of administration in the left arm on 23Jan2021 at 15:20 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history included gestational diabetes (first pregnancy) from an unknown date to an unknown date and two pregnancies on unknown dates. Concomitant medications included unspecified post-natal multivitamins and paracetamol (TYLENOL; Lot Number: SBA22; Expiration Date: Jan2023) taken before getting the vaccine on 23Jan2021 to prevent soreness. The patient previously received the first dose of BNT162B2 on 03Jan2021 (at the age of 34-years-old; Lot Number: EL0142) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination (except the first dose). On 24Jan2021 at 04:00, the patient experienced chills and had a feeling like a heavy weight on her body. On 24Jan2021 at 07:00, the patient had a fever and headache. On 24Jan2021, she also had back pain. The clinical course was as follows: On 23Jan2021, the patient took paracetamol before getting the vaccine as she heard one can feel sore after getting it. The patient received the second dose on 23Jan2021 at 15:20. The patient was okay after she got the vaccine. However, early the next morning (24Jan2021), she had shivering without any fever (later referred to as chills). The chills were something she never experienced in her life. It was like she was in the cold. She could not move, it was that bad. She felt a heavy weight on her whole body. She could not get out of bed. A few hours later at 07:00, she checked her temperature and it was 102.5 degrees Fahrenheit. She took paracetamol. The headache started with the fever around 07:00. She stated she kept taking paracetamol. She did try to stop using paracetamol, but without it, the headache was still there. The back pain was also severe on 25Jan2021. The chills recovered on 25Jan2021 and the fever was recovered on 26Jan2021. The clinical outcomes of the headache and felt like a heavy weight on the body were unknown; while that of the back pain was not recovered. The events of chills, fever, headache, and back pain were reported as serious by the patient (nurse) for being medically significant. The patient (nurse) assessed the events of chills, fever, headache, back pain, and felt like a heavy weight on her body were related to the vaccine.; Sender's Comments: Based on a compatible temporal association and known BNT162B2 vaccine safety profile causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/24/2021,1.0,PVT,TYLENOL,,Medical History/Concurrent Conditions: Gestational diabetes (with first pregnancy only); Gravida II,,,"['Back pain', 'Body temperature increased', 'Chills', 'Discomfort', 'Feeling cold', 'Headache', 'Mobility decreased', 'Pyrexia']",2,PFIZER\BIONTECH, 1022122,NJ,50.0,M,"On 25Jan2021 tested positive for COVID; On 25Jan2021 tested positive for COVID; Headache; Loss of appetite; Dry skin patches; This is a spontaneous report from a Contactable Consumer (patient) via a Pfizer-sponsored program. A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 18:00 at single dose in left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no Prior Vaccinations within 4 weeks. The patient took the first dose of the COVID vaccine on 08Jan2021 and was due to get his second dose but on 25Jan2021 tested positive for COVID. The patient wanted to know if he was allowed to take the second dose. He had a PCR nasal swab that showed the positive COVID diagnosis. He took headache medication after, Tylenol. He had a headache starting on 21Jan2021 and it was lingering on and off but has resolved at this point. He noticed about 8-9 pm the night he got the shot, 08Jan2021, on both feet he had dry skin patches and this lasted about 2 hours; it resolved as this point. He also had a loss of appetite the next day though he ate anyway. That lasted about 8 hours. The outcome of Loss of appetite, Dry skin patches, Headache was resolved. The outcome of other events was unknown. Information about Lot/ Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['COVID-19', 'Decreased appetite', 'Drug ineffective', 'Dry skin', 'Headache', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022123,TX,48.0,M,"tested positive for Covid after receiving the vaccine; tested positive for Covid after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). This 48-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose (with a syringe) on the right arm for protection of COVID 19. The patient medical history and concomitant medications were not reported. Patient stated that he had got the vaccination on 08Jan2021 and ended up testing positive for COVID/tested positive for COVID after receiving the vaccine on 14Jan2021. He was supposed to get the second dose this week. Treatment was none. Outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/14/2021,6.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022124,CA,,M,"Tested positive with Covid19; Tested positive with Covid19; Fever; Loss of smell; Muscular pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced tested positive with covid19, fever, loss of smell, muscular pain in Jan2021. The outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/01/2021,,UNK,,,,,,"['Anosmia', 'COVID-19', 'Drug ineffective', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1022127,AK,71.0,M,"One week to the day after patient's first vaccine he died of a heart attack; This is a spontaneous report from a contactable consumer and from a contactable physician. A 71-year-old male patient (husband) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose on the right arm for COVID-19 immunization. The patient medical history included past heart conditions. No known allergies. Patient took other medications in two weeks. Facility type vaccine was doctor's office/urgent care. No other vaccine received in four weeks. One week to the day after patient's first vaccine he died of a heart attack on 19Jan2021 18:30. Cause of death was heart attack. No COVID prior vaccination. No COVID tested post vaccination. It was unknown if an autopsy was performed. The physician reported that the patient arrived DOA. Physician signed the death certificate based on the patient's prior diagnosis. Physician would not provide additional cause of death medical background without consent. He was not aware of any adverse events experienced from the time of vaccination to the date of death. Follow-up (05Feb2021): This is a follow up spontaneous report from a contactable physician. This physician reported in response to HCP telephonic follow up activity which the following: patient death and cause of death were confirmed. Follow-up attempts are completed. No further information is expected. Information about Lot number is not available.; Sender's Comments: Based on the temporal relationship, the association between the event fatal heart attack with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: One week to the day after patient's first vaccine he died of a heart attack",Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/19/2021,7.0,PVT,,,Medical History/Concurrent Conditions: Heart disorder,,,"['Death', 'Myocardial infarction']",1,PFIZER\BIONTECH, 1022129,CA,40.0,F,"Swelling of hands, fingers; rash and redness on forearms/red rash; Face swollen; Very hot.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Feb2021 at 03:15 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included obesity from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin/clavulanic acid (AUGMENTIN) and dextropropoxyphene napsilate/paracetamol (DARVOCET); both from unknown dates to unknown dates for unknown indications and experienced allergy. On 02Feb2021 at 15:45, the patient experienced swelling of hands/fingers, rash and redness on forearms/red rash, face swollen, and very hot; all reported as serious of being life-threatening. The events required a visit to the urgent care (physician's office). The patient was treated with epinephrine (EPIPEN) and unspecified medications at the urgent care after emergency medical services were called. The clinical outcomes of swelling of hands/fingers, rash and redness on forearms/red rash, face swollen, and very hot were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,OTH,PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE],,Medical History/Concurrent Conditions: Obesity,,,"['Feeling hot', 'Peripheral swelling', 'Rash erythematous', 'Swelling face']",UNK,PFIZER\BIONTECH, 1022134,TX,4.0,F,"a patient received a dose of Fluzone which was stored at 0.7 Celsius for 25 hours and 24 minutes with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from the other health care professional (medical assistant) via agency (Reference number: 00444852). This case involves a 4 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] that was stored at 0.7 Celsius for 25 hours and 24 minutes lot UJ477AA, Expiry date: 30-Jun-2021 via intramuscular route in unknown administration site on 15-Dec-2020 for prophylactic vaccination (Product storage error). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. It was an actual medication error due to incorrect product storage (latency: same day). Reporter can be contacted by Sanofi: Yes, Potential Product technical complaint (PTC): No, Description: Call received from medical assistant (MA) reporting a temperature excursion of unknown cause. Caller reporting PENTACEL, IPOL, FLUZONE QUADRIVALENT Multi Dose Vials (MDVs) AND PREFILLED SYRINGES, MENACTRA, ADACEL, and DAPTACEL at 0.7C for 25 hours and 24 minutes. Caller reported opened IPOL MDVs and opened Fluzone Quadrivalent MDVs. Caller reporting excursion occurring in December 2020. Caller reporting 11 doses of Fluzone Quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines post excursion. Product used: Not Applicable. At the time of report no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/15/2020,12/15/2020,0.0,UNK,,,,,,['Product storage error'],UNK,SANOFI PASTEUR,OT 1022135,TX,,F,"A temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 1 years old male patient for whom reported temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes (Product storage error), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], ,MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], IPV (VERO) [IPOL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] [lot UJ477AA and expiry date: 30-Jun-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination on 20-JAN-2021. Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. It was a case of actual medication error due to product storage error temperature too low. [Latency: at the same time of vaccination]. Details of laboratory data not reported. It was reported that, caller reported opened Ipol Multi dose vials and opened Fluzone quadrivalent MDVs. Caller reporting excursion occurring in Dece-2020. Caller reported 11 doses of Fluzone quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines. It was not reported if the patient received a corrective treatment. At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,01/20/2021,50.0,UNK,,,,,,['Product temperature excursion issue'],UNK,SANOFI PASTEUR,OT 1022146,NY,,F,"Severe Vomiting; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced severe vomiting. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced severe vomiting and was hospitalized for two weeks. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, severe vomiting, was not reported.; Reporter's Comments: This spontaneous report concerns a female patient who experienced a serious event of severe vomiting. The event of occurred on an unknown date after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: unknown, expiration date-Unknown). Treatment and outcome are unknown. There is not enough information of assess the causal association between he reported event and the administration of mRNA-1273 vaccine as critical details such as the date of treatment, onset of the event, patient's medical history including exclusion of other triggers cannot be established. Main field defaults to �possibly related'",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Vomiting'],1,MODERNA,OT 1022154,,,M,"bad reaction to the first one painful hives all over one side of his face; bad reaction to the first one painful hives all over one side of his face; Initial information was received on 18-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient's mother or father) via social media. This case involves adult male patient (age not specified) who had bad reaction to the first one painful hives all over one side of his face (urticaria and pain), while he received INFLUENZA VACCINE. Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history or risk factor were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious bad reaction to the first one painful hives all over one side of his face (urticarial and pain) (unknown latency) following the administration of INFLUENZA VACCINE. It is unknown if the patient experienced any additional symptoms/events. Laboratory data was not provided. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of events were unknown for both events. There will be no information available on the batch number for this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Facial pain', 'Urticaria']",UNK,UNKNOWN MANUFACTURER,OT 1022155,,,U,"sore arm; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional and consumer or non-healthcare professional in the . This case involves patient (unknown demographics) who experienced sore arm (pain in extremity), while he/she received vaccine INFLUENZA VACCINE. The patient's past medical treatment, vaccination, concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor. Patient concomitant medication include vitamins as he took since decades. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE. Patient was saying as your age, you'll find out you've been having a mild case of the flu. It's easy to transmit the flu to others. The 1918 flu was delay for people with good immune systems which killed them. Most employers prefer it, some require it. But he do it because some of his friends are vulnerable. Why kill a buddy over a day. It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine not provided. There were no lab data/results available. It was not reported if the patient received a corrective treatment. The event outcome was unknown for pain in extremity. There will be no information available on the batch number for this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain in extremity'],UNK,UNKNOWN MANUFACTURER,OT 1022156,MI,22.0,F,"22 year old patient received FLUZONE HD/ NO AE; 22 year old patient received FLUZONE HD/ NO AE; a patient received FLUZONE QUAD and FLUZONE HD on same day/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a Pharmacist via Agency(Reference number- 00438020) via call-center and transmitted to Sanofi on 20-Jan-2021. This case involves a 22-years-old female patient who received 0.5 mL INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number and expiry date not reported) in right deltoid and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (batch number: UJ507AA and expiry date: 30-Jun-2021) in left deltoid on same day 20-Jan-2021 for prophylactic vaccination (extra dose administered, product administered to patient of inappropriate age and overdose). The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. It was an actual medication error case due to extra dose administered, overdose and inappropriate age at vaccine administration (latency: same day). Patient received no other vaccines or medications. At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for FLUZONE HIGH-DOSE QUADRIVALENT for this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/20/2021,0.0,UNK,,,,,,['Wrong product administered'],UNK,SANOFI PASTEUR,OT 1022158,IL,33.0,M,"shortness of breath; tongue swelling; Initial information was received on 02-Feb-2021 regarding an unsolicited valid non-serious case from a physician. This case involves a 33-year-old male patient who experienced shortness of breath (dyspnoea) and tongue swelling (swollen tongue), after vaccination with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 13-Jan-2015, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot (C4712AA, expiry date- 27-Mar-2017) via intramuscular route in left deltoid for prophylactic vaccination. On 13-Jan-2015, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via intramuscular route in an unknown administration site for prophylactic vaccination. On 13-Jan-2015, the patient developed non-serious shortness of breath (dyspnoea) and tongue swelling (swollen tongue) about 2 hours following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that, the patient was asking for ingredients for Fluzone Quadrivalent and Adacel. The patient was scheduled to have the COVID-19 vaccine tomorrow and was hoping to get an answer to question before then. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of report, the event outcome was unknown. for both the events. There will be no information available on the lot number of Fluzone Quadrivalent for this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2015,01/13/2015,0.0,UNK,,,,,,"['Dyspnoea', 'Swollen tongue']",UNK,SANOFI PASTEUR,OT 1022160,MI,74.0,M,"24 hours after shot had high fever 101, chills, weakness, became listless, family called 911, client became unresponsive and died in the Emergency room.",Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,PUB,"aspirin, b-12 shot, Bumex, Calcitrail, Colace, Eztimibe,Imdure, Lantus, Novolog, Lorazepam, Metrprol Suc, Nexium, Plavics, Rena, Sertaline, Synthyroid, VIT D",Kidney failure required dialysis 5x weekly,"Cardiac, Diabetes, Kidney failure Kidney transplant with kidney failure",,no,"['Asthenia', 'Chills', 'Death', 'Listless', 'Pyrexia', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 1022215,,,M,"died of pulmonary complications resulting from pneumonia; died of pulmonary complications resulting from pneumonia; Initial information was received on 18-Dec-2020 regarding an unsolicited valid serious social media case from a consumer/other non-professional (patient wife). This case involves male patient (of an unknown age) who died due to pulmonary complications resulting from pneumonia (pneumonia) and (lung disorder), after vaccination with INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site. On an unknown date, the patient had serious pulmonary complications resulting from pneumonia (pneumonia) and (lung disorder) (within a week) following the administration of INFLUENZA VACCINE. These events were leading to death. The event pneumonia was assessed as medically significant. It was unknown if the patient experienced any additional symptoms/events. The reporter stated that, do not trust anything medical without knowing all ingredients and side effects. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. It was unknown if an autopsy was done. The cause of death was reported as Pneumonia and Lung disorder. Information on the lot number was requested.; Sender's Comments: This was a poorly documented social media case involving a male patient (of an unknown age) who had pneumonia and lung disorder and died from it, after receiving INFLUENZA VACCINE from unknown maufacturer. Time to onset is unknown. Additional information regarding patient's relevant medical history, health condition at the time of vaccination, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: died of pulmonary complications resulting from pneumonia; died of pulmonary complications resulting from pneumonia",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Death', 'Lung disorder', 'Pneumonia']",UNK,UNKNOWN MANUFACTURER,OT 1022230,MI,42.0,M,"Idiopathic Thrombocytopenic Purpura, on 1 February 2021, I noticed significant bruising on my body and Petechiae under my eyes. I call the nurse line and requested a CBC. On 2 February, the Emergency Department called me back and stated my platelets were at 6K (over the last 10 years with CLL, they consistently are at 110K-120K). The emergency department directed me to come in and began treatment with Prednisone and platelet transfusion. I was transferred to Hospital where they started IVIG and 40mg of Dexamethasone for four days. I was discharged on 7 February with stable platelets at 42K",Not Reported,,Yes,Yes,6.0,Not Reported,Y,01/28/2021,02/01/2021,4.0,PUB,Venetoclax; vitamin D,none,Chronic Lymphocytic Leukemia,,none,"['Biopsy bone marrow', 'Computerised tomogram', 'Contusion', 'Flow cytometry', 'Full blood count', 'Immune thrombocytopenia', 'Petechiae', 'Platelet count decreased', 'Platelet transfusion']",1,MODERNA,SYR 1022244,DC,44.0,M,Sever vertigo,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/02/2021,02/03/2021,1.0,WRK,No,none,vertigo since 2018,,none,['Vertigo'],1,MODERNA,IM 1022260,MO,77.0,M,"Respiratory distress, seizing, cyanotic, A-Fib with RVR occurring less than 24 hours after receiving his second dose of Moderna.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,01/27/2021,01/28/2021,1.0,OTH,"Allopurinol, Aspirin, Atorvastatin, Calcitrol, Vitamin D, Ferrous Gluconate, Furosemide, Levofloxacin, Lisinopril, Metoprolol, Omeprazole, Sodium Bicarbonate, Tylenol","Hypertension, Chronic Kidney Disease Stage 5, History of CVA, Anemia, Acidosis, Hyperlipidemia","Chronic Kidney Disease stage 5, History of CVA",,"NKA, NKDA","['Atrial fibrillation', 'Cerebrovascular accident', 'Chest X-ray abnormal', 'Cyanosis', 'Laboratory test', 'Pneumonia', 'Respiratory distress', 'Seizure']",UNK,MODERNA, 1022292,LA,73.0,M,"Reported to ER at MC 2/10 with shortness of breath and chills and patient attributed his symptoms to the second vaccination. Lab work in ER revealed WBC of 3.8 and platelet count of 122(baseline usually around 100), Total Bili 3.1. EKG NSR with prolonged ST interval. Chest xray mild left basilar infiltrate - admitted to acute care as observation with diagnosis of pancytopenia. Started on Rocephin for Pneumonia, IV fluids for hydration, accuchecks",Not Reported,,Not Reported,Yes,,Not Reported,U,02/09/2021,02/10/2021,1.0,PHM,"Gabapentin, Glimepiride, Metformin, Quinapril, Sertraline",,Diabetes,,NKA,"['Blood bilirubin decreased', 'Blood glucose increased', 'Chest X-ray abnormal', 'Chills', 'Dyspnoea', 'Electrocardiogram ST segment abnormal', 'Glycosylated haemoglobin', 'Lung infiltration', 'Pancytopenia', 'Platelet count decreased', 'Pneumonia', 'White blood cell count decreased']",2,MODERNA,IM 1022329,SC,84.0,F,Patient presented to the ED after going home from the vaccine clinic. Patient waited the recommended time before leaving the facility,Not Reported,,Yes,Yes,,Not Reported,U,02/10/2021,02/10/2021,0.0,PVT,insulin,,diabetes,,,"['Extra dose administered', 'Unevaluable event']",3,PFIZER\BIONTECH,IM 1022397,KY,98.0,F,Death 2/9/21,Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,,01/16/2021,02/09/2021,24.0,SEN,,Resident was end of life/comfort measures which started 7/2/2020. diagnosed with covid 1/20/21. received first vaccination 1/16/21 and second dose 2/6/21. expired 2/9/21.,,,,['Death'],2,PFIZER\BIONTECH,IM 1022440,FL,69.0,M,"The decedent experienced severe chest pain and dyspnea approximately nine days following the first series of the vaccine. He reported to family members that he was having a ""severe reaction"" to the vaccine and believed it was acute pericarditis due to the same symptoms he experienced prior. He reported that on 2/1/21 around 0300 hours, the symptoms were the most severe and he was going to seek medical attention, but did not. He waited till the convenient store opened and purchased OTC Tylenol for relief of symptoms. He continued to have dyspnea and chest pain up until 2/9/21, when he called 911 complaining of chest pain and was found to have a STEMI; subsequently died at Hospital in the ER.",Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,01/23/2021,02/01/2021,9.0,PHM,None,None,"HTN, hyperlipidemia, pericarditis (diagnosed in 2014)",,None,"['Acute myocardial infarction', 'Chest pain', 'Death', 'Dyspnoea', 'Pericarditis']",1,MODERNA,IM 1022458,,67.0,F,Moderna Vaccine - hypertensive to 220,Not Reported,,Not Reported,Yes,,Not Reported,,02/10/2021,02/10/2021,0.0,UNK,HCTZ-Losartan,,,,,['Hypertension'],UNK,MODERNA, 1022478,PA,59.0,F,Received vaccine at 0830 at 1400 developed numbness on left side of face,Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/10/2021,02/10/2021,0.0,WRK,,,"diabetes, GERD, Smoker x 40 years",,,"['Angiogram cerebral', 'Blood test', 'Computerised tomogram', 'Electrocardiogram', 'Hypoaesthesia', 'Magnetic resonance imaging']",2,MODERNA,IM 1022496,WI,77.0,M,"STEMI, transferred via helicopter to Hospital.",Not Reported,,Yes,Yes,,Not Reported,N,02/04/2021,02/05/2021,1.0,PVT,Unknown,,Hypertension Hyperglycemia,,no allergies,['Acute myocardial infarction'],UNK,MODERNA,IM 1022509,LA,59.0,M,Rectal bleeding on day 2 close to 40 hours after getting 2nd shot of the Moderna series. pt had severe fatigue that morning that continued to increase & he left work early. Once he got home he used the bathroom and had visible blood noted with BM. Painless rectal bleeding x 1 episode. was set up with GI for upper & lower scope both scopes were negative,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/01/2021,02/02/2021,1.0,OTH,,left tib/fib fx left rib fx clavicle fx pelvis pneumothorax,Hyperlipidemia,,NKDA,"['Colonoscopy', 'Endoscopy gastrointestinal normal', 'Fatigue', 'Full blood count', 'Oesophagogastroduodenoscopy', 'Rectal haemorrhage']",2,MODERNA,IM 1022513,WI,71.0,M,"Arrived to ED with slurred speech, potential stroke, was transferred to Hospital for higher level of care.",Not Reported,,Yes,Yes,,Not Reported,N,02/04/2021,02/05/2021,1.0,PVT,unknown,,,,no allergies,"['Angiogram cerebral abnormal', 'Arteriogram carotid abnormal', 'Cerebrovascular accident', 'Dysarthria', 'Vertebral artery occlusion']",UNK,MODERNA, 1022516,NH,46.0,M,"experienced significant shortness of breath, heavy wheezing, and coughing on the weekend of 2/6/2021. Slight wheezing had been ongoing for months (difficulty breathing in January of 2020 when diagnosed with influenza A and intermittent slight wheezing continued throughout the year). Symptoms became worse throughout the weekend. I did continue my normal routine (taking trash to the dump, helped move a heavy tank out of a walkout basement, and moving twelve 40 pound bags of wood pellets from store into truck then from truck into my home on day of hospitalization) Hospitalized on 2/7/2021",Not Reported,,Yes,Yes,3.0,Not Reported,U,01/18/2021,02/06/2021,19.0,PVT,"pantoprazole sodium, atorvastatin calcium, fish oil, krill oil, vitamin d, vitamin b-12, fluticisone proprionate",none,"elevated cholesterol, seasonal allergies",,none,"['Blood test normal', 'Chest X-ray normal', 'Computerised tomogram abnormal', 'Cough', 'Dyspnoea', 'Pulmonary embolism', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 1022529,WI,70.0,M,"Pt suffered Cardiac Arrest and respiratory arrest on 2/9/21 and passed away at a local hospital. He had multiple health conditions likely contributing to this. he arrested at home and CPR was attempted and unsuccessful. Pt received his Covid vaccine #1 on 1/27/21. No issues were noted after vaccine and was due for his 2nd dose next week. However, we were notified he passed away on 2/9/21. Very likely death not at all related to vaccine but wanted to document as patient was in the middle of the covid vaccine series.",Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/09/2021,13.0,PVT,"Venlafaxine Hcl ER 150 daily, Multi vitamin, Aspirin 81mg, Nitro 0.4 prn, Vitamin E 200 daily, Ipratropium-Albuterol 0.5-2.5 inhalation q 6 hrs, omeprazole 20mg daily, isorbide monintrate ER 60mg daily, spironolactone 50mg , mens multi vita",pt was seen 1/8/21 for a Scatica flare Pt had a follow up colonscopy performed 1/21/21 where a couple polyps were found and diverticulosis,"pt has COPD and used Oxygen at night, Coronary atherosclerosis, Diabetes Type 2, hypertriglyceridemia, OSA, hyperlipidemia, hypertension, IBS, pulmonary emphysema, acute or chronic heart failure, morbid obesity, atrial fibrillation, depression, hypercholesteremia, stage 3 kidney disease",,"Amoxicillin(rash), Lisinopril (cough)","['Cardiac arrest', 'Death', 'Respiratory arrest', 'Resuscitation']",1,PFIZER\BIONTECH,IM 1022552,GA,83.0,M,Patient died of cardiac arrest on 01/21/2021,Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/21/2021,7.0,PVT,"amiodarone (PACERONE) 200 mg tablet aspirin 81 mg chewable tablet(Expired) atorvastatin (Lipitor) 40 mg tablet cholecalciferol, vitamin D3, (VITAMIN D3) 1,000 unit capsule furosemide (LASIX) 40 mg tablet LORazepam (Ativan) 0.5 mg tablet met",Nervous Coronary artery disease of native artery of native heart with stable angina pectoris (CMS/HCC) Acute chest pain Unstable angina (CMS/HCC) � Circulatory VT (ventricular tachycardia) (CMS/HCC) Occlusion and stenosis of unspecified carotid artery PVD (peripheral vascular disease) (CMS/HCC) Non-rheumatic mitral regurgitation Hypertensive heart disease with chronic systolic congestive heart failure (CMS/HCC) Chronic systolic congestive heart failure (CMS/HCC) Idiopathic hypotension � Endocrine/Metabolic Mixed hyperlipidemia Hyperkalemia � Other ICD (implantable cardioverter-defibrillator) in place Increased BMI �,Nervous Coronary artery disease of native artery of native heart with stable angina pectoris (CMS/HCC) Acute chest pain Unstable angina (CMS/HCC) � Circulatory VT (ventricular tachycardia) (CMS/HCC) Occlusion and stenosis of unspecified carotid artery PVD (peripheral vascular disease) (CMS/HCC) Non-rheumatic mitral regurgitation Hypertensive heart disease with chronic systolic congestive heart failure (CMS/HCC) Chronic systolic congestive heart failure (CMS/HCC) Idiopathic hypotension � Endocrine/Metabolic Mixed hyperlipidemia Hyperkalemia � Other ICD (implantable cardioverter-defibrillator) in place Increased BMI �,,none,"['Cardiac arrest', 'Death']",1,MODERNA,IM 1022613,IA,85.0,F,"Bell's Palsy- steroids, Valtrex, speech therapy. ongoing left facial paralysis",Not Reported,,Not Reported,Yes,2.0,Yes,N,02/07/2021,02/08/2021,1.0,PVT,"Alendronate, atorvastatin, calcium, vitamin D, candesartan- hct, metformin xr, naproxen, nifedipine, miralax",none,"diabetes, osteoarthritis, hyperlipidemia, hypertension",,NKDA,"['Echocardiogram', 'Facial paralysis', 'Magnetic resonance imaging brain']",UNK,MODERNA, 1022622,FL,80.0,F,"chest pain, diaphoresis, incontinence, N/V, dizziness; symptoms are no longer occuring after be treated and released from hospital 2/3/21",Not Reported,,Not Reported,Yes,,Not Reported,U,01/27/2021,01/29/2021,2.0,OTH,"lipitor, BP meds, oral hypoglycemics; daughter could not recall all meds",,"HTN, high cholesterol, diabetes",,,"['Acute myocardial infarction', 'Catheterisation cardiac', 'Chest pain', 'Dizziness', 'Hyperhidrosis', 'Incontinence', 'Nausea', 'Stent placement', 'Vomiting']",1,PFIZER\BIONTECH,IM 1022646,SD,45.0,F,"Fever, cough, congestion, nausea, fatigue, headache, MS flare, hospitalized for MS flare, received high dose steroids for MS flare (4 days)",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,12/18/2020,12/26/2020,8.0,PVT,Ampyra 10mg twice a day Gabapentin 300 mg 3 tablets 3 times a day Ibuprofen 200 mg 4 tablets daily Tramadol 100 mg 4 times a day,,Multiple sclerosis,,,"['Condition aggravated', 'Cough', 'Fatigue', 'Headache', 'Multiple sclerosis relapse', 'Nausea', 'Pyrexia', 'Respiratory tract congestion', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,IM 1022651,TX,90.0,F,"nausea, vomiting, fever, and fall, and hospital admission",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/09/2021,02/09/2021,0.0,PVT,"Amlodipine, Asprin, Isosorbide monotritate, Lasix, Losartan, Metoprol tartrate, omeprazole, potassium chloride, sertraline, tramadol, Tylenol, vytorin",unknown,"arthritis, cellulitis, CHF, edema, dyslipidemia, fungal dermatitis, GERD, hypertension, shingles, venous hypertension",,codiene,"['Blood chloride increased', 'Blood cholesterol decreased', 'Blood creatine normal', 'Blood glucose increased', 'Blood lactic acid normal', 'Blood potassium decreased', 'Blood potassium normal', 'Blood sodium normal', 'Blood urine present', 'Carbon dioxide decreased', 'Chest X-ray normal', 'Fall', 'Nausea', 'Neutrophil percentage increased', 'Pyrexia', 'Vomiting', 'White blood cell count increased', 'X-ray limb']",2,MODERNA,IM 1022685,IN,86.0,M,"Received Pfizer Covid Vaccine in the AM on 2/9/21. Arrived to emergency department later the same day complaining of nausea, weakness, fatigue, Vomiting, Diarrhea. Post operative diagnosis, Ischemic colon/toxic megacolon.",Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/09/2021,0.0,PVT,,,"Parkinson's disease, Diabetes, Leukemia",,No known allergies,"['Asthenia', 'Colitis ischaemic', 'Diarrhoea', 'Fatigue', 'Intestinal ischaemia', 'Megacolon', 'Nausea', 'Surgery', 'Vomiting']",2,PFIZER\BIONTECH,IM 1022701,AZ,41.0,F,"I suddenly developed Tinnitus after receiving Pfizer COVID-19 vaccine dose #2. It's so loud, I have difficulty concentrating and sleeping. I happened to tell someone else about this and she reported that her Tinnitus was significantly worse following dose #2 of Pfizer vaccine.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/01/2021,02/05/2021,4.0,OTH,"Bupropion XL 300 mg, Propranolol 20 mg, Linzess 290 mcg,",None,"Depression, anxiety, IBS",,Sulfa and mold/yeast,"['Disturbance in attention', 'Insomnia', 'Tinnitus']",2,PFIZER\BIONTECH,SYR 1022723,NC,84.0,F,"C/O chills, aches (new onset), headache (chronic) 12 days after COVID dose #1. Patient found to be hypotensive and tachycardic in ED, was admitted due to complex medical history. Hypotension, tachycardia, and AKI resolved after 1L LR.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/21/2021,02/02/2021,12.0,MIL,- Nitroglycerin SL 400mcg/ spray 4.9 gm/btl- 1spray under tongue up to 3 times in 3 minutes for chest pressure or pain - Klonopin - 0.5mg- 1 tab by mouth 3 times daily as needed for anxiety - Restoril 30mg- 1 tab at bedtime as needed for,Headaches and arthralgias x3mo per husband,"Medical: - CAD s/p CABG x 4 in 2013 (followed by Cards, Dr. - PAFIB w RVR 3/31/2020, CHADS 2 score 4 - CVA - PE -20lb wt loss in 3 mos w dark stools noted by GI, Dr., 11/19, GI wu pending - Esophageal reflux - Prediabetes - Hyperlipidemia - Essential hypertension - Anxiety disorder - Osteopenia - Essential hypertriglyceridemia - Hypertension -Insomnia - Dementia - Anxiety - Chronic back pain Surgical / Procedural: - Partial Hysterectomy - 1976 - Quadruple Cardiac Bypass - 12/5/2013 - Right Saphenous vein removal - 12/5/2013.",,"Phenylephrine & tropicamide (chest pain); opioids (nausea); Zocor & a specific brand of acetaminophen (brand UNK, reactions UNK, but listed in her Allergy tab)","['Acute kidney injury', 'Blood creatine phosphokinase MB', 'Blood creatine phosphokinase MB increased', 'Blood creatinine increased', 'Blood gases abnormal', 'Blood urea increased', 'Brain natriuretic peptide increased', 'Chest X-ray', 'Chills', 'Computerised tomogram head', 'Computerised tomogram head normal', 'Full blood count', 'Haemoglobin decreased', 'Headache', 'Hypercalcaemia', 'Hyperglycaemia', 'Hypotension', 'Metabolic function test', 'Pain', 'Tachycardia', 'Troponin increased', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1022756,,62.0,M,sustained Atrial Fibrilation (AFIB),Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/05/2021,02/09/2021,4.0,PVT,,None,Post prostate CA,,none,['Atrial fibrillation'],1,PFIZER\BIONTECH, 1022812,,65.0,F,Approximately 30 minutes after receiving the vaccine I lost complete hearing in my left ear. I waited until the next morning to see if hearing would return. It did not and I contacted my doctor at the Clinic and was referred for an audiology test on Thursday at 9:30am followed by a appointment with an ENT. My hearing loss was profound and I was started on high dosages of steroids for a 14 day course of action. I also had a head MRI done on Monday February 8 with no significant findings. My hearing has begun to improve but at this point is not back to normal and it may never be the same. My biggest question is whether or not I should take the second vaccine. I also have a significant bruise at the injection sight that I still have 10 days later.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/02/2021,02/02/2021,0.0,OTH,"metformin, lipitor, Vit D, Calcium, B!@",none,,,Bee Stings,"['Acoustic stimulation tests abnormal', 'Audiogram', 'Deafness unilateral', 'Injection site bruising', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging normal']",1,PFIZER\BIONTECH,SYR 1022897,,38.0,M,"Debilitating headache; body ache; vomiting; nausea; chills; This is a spontaneous report from a contactable consumer (patient) and the consumer's spouse. A 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EZ3246) via an unspecified route of administration on 20Jan2021 (at the age of 38-years-old) as a single dose for COVID-19 vaccination. Medical history was reported as ""no"" and concomitant medications (""other products"") were reported as ""no"". The patient experienced ""debilitating headache"", ""body ache"", ""vomiting"", ""nausea"" and ""chills"", all on unspecified dates. It was reported that the patient went to the emergency room for the adverse events and was hospitalized on 26Jan2021 for the events ""debilitating headache"", ""body ache"" and ""vomiting"". The consumer called to report ""a debilitating headache afterward (after the first dose of the vaccine) that persisted for 3 days and was still present, but diminished, for a total of 3.5 days. He also reported nausea, vomiting, chills, body ache, no fever. He went to the ER (emergency room) and was treated with fluids and other meds."" The patient wanted to know whether the symptoms would be worse with the second shot and if they were more commonly reported after the second shot? The patient's spouse also called and reported that her husband ""received the COVID Pfizer Vaccination (COVID-19 Vaccine) last Wednesday and had a really bad experience with that afterwards."" She stated that he received the vaccine at a hospital. When asked about the start date of the adverse reaction the reporter stated ""Saturday 23rd."" When clarification was requested regarding the adverse reaction, the reporter stated, ""He had an extremely bad reaction to it. His head was hurting so bad that it was more than a migraine and he was vomiting, body ache but way worse than anyone that he has ever talked to, that has had it. He had to go to the hospital for it, it was bad."" The reporter stated that the date of hospitalization was ""yesterday 26Jan2021."" The reason for hospitalization was not confirmed further. When asked about the outcome of the events the reporter stated, ""A little bit better but not much"". The reporter wanted to know whether ""this was a common thing, are you seeing this happening?"" The clinical outcome of the events ""debilitating headache"", ""body ache"", ""vomiting"", ""nausea"" and ""chills"" were all not recovered/not resolved.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/20/2021,,,PVT,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No",,,"['Adverse event', 'Chills', 'Cluster headache', 'Headache', 'Nausea', 'Pain', 'Vomiting']",1,PFIZER\BIONTECH, 1022898,,,F,"Spleen enlarged (worsening splenomegaly); Spleen enlarged (worsening splenomegaly); This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. Medical history included ongoing Hodgkin's Lymphoma, ongoing splenomegaly (at baseline). Concomitant medications were not reported. The patient experienced spleen enlarged (worsening splenomegaly) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included imaging procedure: increased significantly in size on unknown date. Her oncologist was not overly convinced that her splenomegaly was related to her Hodgkin's Lymphoma, though was going to send her for splenectomy (not jet scheduled). The case was reported as non-serious. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,Hodgkin's lymphoma; Splenomegaly (At baseline),,,,"['Computerised tomogram abdomen abnormal', 'Condition aggravated', 'Imaging procedure abnormal', 'Splenomegaly']",1,PFIZER\BIONTECH, 1022899,OK,29.0,F,"anxiety attack; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; in the evening arm swelled/swelling went down to size of pin hole; there was a welt at the vaccination site / there was still a little knot on arm; fever; night sweats; body rash/ rash beneath eyes; blister sores; swelling of eyes; arm was painful and is still; This is a spontaneous report from a contactable consumer. A 29-years-old female patient, a registered nurse, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number BK9231, in Hospital, via an unspecified route of administration in left arm on 04Jan2021 at 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of the vaccination. Concomitant medications included ibuprofen and cetirizine hydrochloride (ZYRTEC). The patient reported that 2 mins after the shot, her left arm felt heavy and was hard to move and, on 04Jan2021 at 14:15 she had tingling/dead feeling; in the evening arm swelled and there was a welt at the vaccination site. On an unknown date in Jan2021 she had fever at 102 �F for 48 hours and swelling went down to size of pin hole; her arm was painful and was still sore, there was still a little knot on arm. On 07Jan2021 she experienced an anxiety attack; 20 days after, in Jan2021 the patient experienced night sweats. She also experienced body rash and little blister sores on her body and both arms, swelling of eyes and rash beneath eyes. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered to the patients for the events. On 25Jan2021 the patient underwent COVID-19 test via Nasal Swab which showed negative results. The event ""Fever"" resolved after 48 hours, whereas the outcome of all the reported events was unknown at time of the report.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/01/2021,,PVT,IBUPROFEN; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Anxiety', 'Blister', 'Eye swelling', 'Induration', 'Injected limb mobility decreased', 'Injection site reaction', 'Limb discomfort', 'Mobility decreased', 'Night sweats', 'Pain in extremity', 'Paraesthesia', 'Peripheral swelling', 'Pyrexia', 'Rash', 'SARS-CoV-2 test negative', 'Urticaria', 'Vaccination site reaction']",1,PFIZER\BIONTECH, 1022918,MO,96.0,F,"Resident complained of feeling ""hot"" at supper time. Had emesis an hour or so later. Became hypoxic and was transferred to the hospital emergency room. Her evaluation in the ED revealed continued presence of UTI, leukocytosis (19.8), and renal insufficiency (BUN 22 Cr. 1.3) BP 99/63; P 74; Temp 98.1; RR 16; and O2 sat of 95% with 2 LPNC (she is typically on RA). CXR reported changes most consistent with CHF with cardiomegaly and bilateral pulmonary vascular prominence. Bibasilar pleural effusions greater on the right than left with pulmonary edema. Large hiatal hernia and likely old chronic wedge defromities involving the mid thoracic vertebral body. She was admitted for IV antibiotics. She expired 2/6/2021",Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,SEN,"Alprazolam, Furosemide, Keflex, Losartan, Metoprolol, Protonix",Urinary Tract Infection,"Atrial fibrillation, heart failure, Gerd, Dysphagia, PVD, dementia, anxiety disorder, osteoarthritis",,"Ciprofloxacin, Shellfish","['Blood creatine abnormal', 'Blood urea abnormal', 'Cardiac failure congestive', 'Cardiomegaly', 'Chest X-ray abnormal', 'Death', 'Feeling hot', 'Hiatus hernia', 'Hypoxia', 'Leukocytosis', 'Pleural effusion', 'Pulmonary oedema', 'Pulmonary vascular disorder', 'Renal failure', 'Spinal fracture', 'Urinary tract infection', 'Vomiting', 'White blood cell disorder']",2,MODERNA,IM 1022924,CA,83.0,F,Systemic: Other- encephalopathy,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/01/2021,02/04/2021,3.0,SEN,,,,,,['Encephalopathy'],2,PFIZER\BIONTECH,IM 1022969,AZ,77.0,M,"This patient received his 2nd dose of Pfizer vaccine yesterday. Today, he had focal weakness and difficulty walking and was transferred for suspected stroke.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/04/2021,02/05/2021,1.0,PVT,NO Chronic Med,,,,NOne,"['Asthenia', 'Cerebrovascular accident', 'Computerised tomogram', 'Gait disturbance']",2,PFIZER\BIONTECH,IM 1023010,CA,69.0,F,"Community member stated had ""left arm weakness."" stated she usually had left arm weakness in the past after her ""brain surgery in 2017."" At 1600 community member stated she felt better and wanted to go home. Observer RN noted weakness to left lower extremity as well and called Rapid Response Team at 1607. Community member remained responsive and alert and oriented x4, followed commands.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/09/2021,02/09/2021,0.0,PVT,unknown,unknown,"Per Community member; had ""brain surgery 2017.""",,NKA,['Muscular weakness'],1,PFIZER\BIONTECH,IM 1023060,GA,68.0,M,Patient developed right sided hemiparesis on 2/5/2021. He presented to hospital on 2/7/2021 with these symptoms and diagnosed with an acute CVA and internal carotid artery occlusion. He was admitted to the hospital and discharged to inpatient rehab on 2/11/2021.,Not Reported,,Not Reported,Yes,4.0,Not Reported,U,01/15/2021,02/05/2021,21.0,PVT,,,,,No known allergies,"['Carotid artery occlusion', 'Cerebrovascular accident', 'Computerised tomogram head', 'Hemiparesis', 'Magnetic resonance imaging brain abnormal', 'Ultrasound Doppler']",1,MODERNA,IM 1023061,CA,74.0,M,"Pt received the vaccine on 1/30/21 Pt reported symptoms of left armpit pain to wife on 2/7/21, went to work 4 am 2/8/21 and found face down, dead at work later that morning. Pt worked at a pet store, per wife he did complete his tasks and generally comes home by 7:30 am. Wife called when pt did not come back home and he was found dead.",Yes,02/08/2021,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/08/2021,9.0,PVT,Levothyroxine 100 mcg tab once a day,"pt had teeth pulled for possible dental implants , non ulcer dyspepsia, treated for diverticulitis 1/6/21","COPD; hypothyroidism; cricopharyngeal achalasia post surgical treatment, aortic atherosclerosis, hx of perforated ulcer from aspirin use",,,"['Axillary pain', 'Death']",1,MODERNA,IM 1023074,OR,49.0,F,"First week had headache, nausea, dizziness with room spinning. Starting the second week had a Crohn's flare with abdominal pain and diarrhea, which has continued. Hospitalized due to dehydrating and low potassium, given steroids, fluids, and potassium supplement.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/20/2021,01/21/2021,1.0,PVT,"Humira, Levothyroxine, Cytomel, Singular, Omeprazole",None,"Crohn's, Hypothyroid, Bigeminy",,"Latex, Morphine, Dilaudid, Avocados, Gluten","['Abdominal pain', 'Blood potassium decreased', 'Condition aggravated', ""Crohn's disease"", 'Dehydration', 'Diarrhoea', 'Dizziness', 'Full blood count', 'Headache', 'Metabolic function test', 'Nausea', 'Stool analysis']",1,PFIZER\BIONTECH,IM 1023338,WI,36.0,F,"Mental foggyness/forgetful; Chills; Migraine; Dizziness; Fatigue; Loss of appetite; Food tasted salty/rotten; Diarrhea; Vomiting; intestinal discomfort; Cough with some shortness of breath (relieved with asthma inhaler); Cough with some shortness of breath (relieved with asthma inhaler); This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Solution for injection; lot number: EL3249, expiration date: unknown) via unspecified route of administration in the arm left on 22Jan2021 08:00 at single dose for COVID-19 immunisation. Medical history included asthma, multifocal myoclonus, IBS/lynch syndrome, hypothyroidism, Allergy: Dairy (milk allergy), allergies, alcohol allergy, Allergy: beef (meat allergy), and allergy: adhesives (dermatitis contact). Patient was taking unspecified concomitant medications. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: urgent care center (also reported as Doctor's office). The patient experienced mental foggyness/forgetful, chills, migraine, dizziness, fatigue, loss of appetite, food tasted salty/rotten, diarrhea, vomiting, intestinal discomfort, and cough with some shortness of breath (relieved with asthma inhaler); all on 23Jan2021 at 06:00. The events resulted to: Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken in response to all events (unspecified). Patient also had teleconference with doctor. Outcome of all events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/23/2021,1.0,OTH,,,Medical History/Concurrent Conditions: Alcohol allergy; Allergy; Asthma; Dermatitis contact (Allergy: adhesives); Hypothyroidism; Lynch syndrome (IBS/lynch syndrome); Meat allergy (Allergy: beef); Milk allergy (Allergy: Dairy); Myoclonus (multifocal myoclonus),,,"['Abdominal discomfort', 'Chills', 'Cough', 'Decreased appetite', 'Diarrhoea', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Memory impairment', 'Migraine', 'Taste disorder', 'Vomiting']",1,PFIZER\BIONTECH, 1023339,TN,51.0,F,"2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch throat; body aches; dizziness; headache; lymp nodes tender; eye swelling; blurred vision; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; tooth pain; jaw pain; i also had leg and bilateral foot pain x 4 days; all my mucos membranes were red, irritated and blistered; all my mucos membranes were red, irritated and blistered; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 19Jan2021 10:45 at a single dose on left arm for COVID-19 immunization. Medical history included allergies: sulfa. Concomitant medication included bupropion (BUPROPION). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced 2 hrs after 2nd injection, 'felt like I was burning from inside out', Skin red, flushed, rash, scratch throat, temp, body aches, dizziness, headache, lymph nodes tender, eye swelling, blurred vision, 'blisters on the trunk of my body as well as lips and gums', tooth pain, jaw pain. All of these symptoms lasted 3 days (as reported), blisters and gum issues lasted 4 days (as reported). Patient also had leg and bilateral foot pain x 4 days. All mucous membranes were red, irritated and blistered. The adverse events were experienced on 19Jan2021 12:30. Therapeutic measures were taken as a result of the events which included Benadryl, steroid injection. The outcome of the events was recovering (as reported). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,PVT,BUPROPION,,Medical History/Concurrent Conditions: Sulfonamide allergy (Allergies: sulfa),,,"['Blister', 'Body temperature', 'Burning sensation', 'Dizziness', 'Erythema', 'Eye swelling', 'Flushing', 'Gingival blister', 'Headache', 'Lip blister', 'Lymph node pain', 'Pain', 'Pain in extremity', 'Pain in jaw', 'Rash', 'Throat irritation', 'Toothache', 'Vision blurred']",2,PFIZER\BIONTECH, 1023340,MO,45.0,F,"Mental fog; Soreness at injection site; Fatigue; Fever ( low grade: 1-2 degrees over basal); This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN 5318), via an unspecified route of administration on the left arm on 27Jan2021 09:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient is not pregnant. Concomitant medication included esomeprazole magnesium (NEXIUM), ibuprofen (ADVIL), beclometasone dipropionate (QNASL), diphenhydramine hydrochloride (BENADRYL) and doxylamine succinate (UNISOM). The patient previously took naproxen (ANAPROX) and experienced allergy. The patient experienced mental fog, soreness at injection site, fatigue and fever ( low grade: 1-2 degrees over basal) on 27Jan2021 18:00. No treatment and hospitalization was caused by the events. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,WRK,NEXIUM [ESOMEPRAZOLE MAGNESIUM]; ADVIL [IBUPROFEN]; QNASL; BENADRYL; UNISOM [DOXYLAMINE SUCCINATE],,,,,"['Fatigue', 'Feeling abnormal', 'Injection site pain', 'Pyrexia']",1,PFIZER\BIONTECH, 1023341,NY,63.0,M,"Recurrence of Atrial fibrillation; Recurrence of Atrial fibrillation; This is a spontaneous report from a contactable physician (patient himself). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on the right arm on 25Jan2021 13:00 at a SINGLE DOSE for COVID-19 immunization. The patient's medical history included hyperlipidemia, GERD (gastrooesophageal reflux disease), and atrial fibrillation, all from an unknown date and unknown if ongoing. The patient had prior ablations for Afib. The patient had no allergies to medications, food, or other products. On 04Jan2021, 18:00, the patient took the first dose of BNT162B2 (lot number and expiry date unknown) via an unspecified route of administration on the right arm at a single dose for COVID-19 immunization. Concomitant medications included dofetilide, diltiazem, loratadine, rosuvastatin calcium (CRESTOR), and omeprazole (OMEPRA); the patient received these medications within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 28Jan2021 02:00, the patient experienced recurrence of atrial fibrillation after 6 months, the last episode was within a month after an ablation. No treatment was received in response tot eh event. Outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: The reported recurrence of atrial fibrillation was more likely due to natural recurrence of underlying atrial fibrillation, and unlikely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/28/2021,3.0,PVT,DOFETILIDE; DILTIAZEM; LORATADINE; CRESTOR; OMEPRA,,Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac ablation (Afib occurred within a month after abation); GERD; Hyperlipidemia,,,['Atrial fibrillation'],2,PFIZER\BIONTECH, 1023342,,,F,"respiratory distress; hard time breathing; felt a lump in her throat; making it hard to swallow; This is a spontaneous report from a contactable nurse (patient's daughter). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on unspecified date at a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient's daughter reported that her mother received the first dose of the Covid vaccine and 2 hours later, her mother had a hard time breathing and felt a lump in her throat, making it hard to swallow. The respiratory distress only lasted a few minutes, but the feeling of a lump in her throat lasted 4 days. The patient's daughter wanted to know if it is ok and safe for her mother to receive the second dose of the vaccine. The patient recovered from the event respiratory distress on an unspecified date. Outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Dysphagia', 'Dyspnoea', 'Respiratory distress', 'Sensation of foreign body']",1,PFIZER\BIONTECH, 1023343,MN,41.0,F,"Fainted; blacked out; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), intramuscular on 27Jan2021 10:15 at a single dose on right arm for COVID-19 immunization. Medical history included low iron. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient had no allergies to medications, food or other products. Concomitant medications included ferrous sulfate, vitamin c [ascorbic acid] (VITAMIN C), chondroitin sulfate, glucosamine sulfate (GLUCOSAMINE CHONDROITIN SULFATE). The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization (brand: Pfizer, lot number: EK9231, administration time: 04:30 PM, route: intramuscular, vaccine location: right arm, dose number: 1). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 23:45, the patient fainted and blacked out. No treatment was given for the adverse events. The events resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visits. It was unknown if the patient has been tested for COVID-19 since the vaccination. The patient was recovering from the events.; Sender's Comments: Based on the compatible time association, the events fainted and blacked out are possibly related to suspect vaccine BNT162B2 administration.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,PVT,FERROUS SULFATE; VITAMIN C [ASCORBIC ACID]; GLUCOSAMINE CHONDROITIN SULFATE,,Medical History/Concurrent Conditions: Iron low,,,"['Loss of consciousness', 'Syncope']",2,PFIZER\BIONTECH,OT 1023344,MI,,M,"heart attack; kidneys were compromised; muscles were tightening; could hardly walk; cough; lethargic; chills; reflux in his chest; blood count went down; severe cramping in leg; Difficulty breathing; This is a spontaneous report from a contactable consumer (patient's wife). An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Medical history cardiac bypass surgery years ago. The patient's concomitant medications were not reported. The reporter stated that on 14Jan2021, the reporter and the patient had the first Pfizer vaccine dose, their second dose is scheduled on 04Feb2021. She stated that 2 days after the first dose, on 16Jan2021, the patient's muscles were tightening, could hardly walk, had a cough, was lethargic, had chills and was compalaining of having reflux in his chest. She stated that they had appointments that day with their Internist and their Cardiologist. Both physicians felt ""all his symptoms"" were probably from the vaccine. That night she took him to the ER and he had had a heart attack. They did a cardiac cath and had one of two stents put in. His ""kidneys were compromised"" and the HCP couldn't give the amount of dye needed to add another stent. So he still needs another stent. Also the ""blood count went down."" She added that her husband had cardiac bypass surgery years ago. They were concerned that he had a heart attack and asked if he should get the second dose. She added that on 16Jan2021, the patient had severe cramping in the leg, lethargic, chills, and difficulty breathing and he ended up going to the doctor. They had the vaccine on the 14Jan2021. Saturday it just hit him like a ton of bricks. He got worse on Saturday and worse on Sunday and even more worse on Monday. She took him to the Internist and the Cardiologist, they checked him and found he was okay, just lethargic. He also complained of reflux in chest. Around 11:00 that night he had a heart attack and she had to get EMS. He ended up getting a stent and they have to do another one and they had to do something with his kidneys. She wanted to know if he should get the second vaccine. She would hate to put him in a tailspin again. They were trying to get over this huge problem with his heart and then kidneys. They had to hydrate his kidneys in order for dye to go through so it wouldn't damage his kidney during catherization. She knows that one of the things the vaccine does is it activates the immune system to keep you from getting Covid. She wanted to know if it activates other stuff in the body. She asked if it would be recommended for him to slow it down since he just had the first dose. He is going to the Cardiologist and they say to discuss with the Internist, but she would like to speak with someone. She declined report and asked about the wait time to speak with someone since she does not want to leave him alone for long since he just got home from hospital. The outcome of the events was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/14/2021,01/16/2021,2.0,UNK,,,Medical History/Concurrent Conditions: Coronary artery bypass (years ago),,,"['Blood count abnormal', 'Catheterisation cardiac', 'Chills', 'Coronary arterial stent insertion', 'Cough', 'Dyspnoea', 'Gait disturbance', 'Gastrooesophageal reflux disease', 'Lethargy', 'Mobility decreased', 'Muscle spasms', 'Muscle tightness', 'Myocardial infarction', 'Renal failure']",1,PFIZER\BIONTECH, 1023345,HI,89.0,F,"Got sick; Headache; Shortness of breath; Passed out; Dizzy/ Dizziness; Tightness in her chest; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date unknown, first dose, intramuscular on 26Jan2021 at single dose on right arm for COVID-19 immunization. Medical history included mastectomy, surgery for metaplastic carcinoma. She received 4 units of blood and reacted to the blood and itched from her head to toe and they treated her with prednisone for that. She said that the metaplastic carcinoma was 10 inches big and half of her front was removed. Other medical history and past drugs included allergic to Bactrim, Sulfa drugs, Cortisone, Zocor, Keflex, Macrodantin, Penicillin, Vicodin (took three times and thought she was going to die; coughed for a year and couldn't even sleep because she developed Pericarditis), Benazepril, Levaquin, Losartan, Niaspan (whole body turned red), Pravastatin. On 07Jan2021, she had an appointment with her doctor who first advised her not to take the vaccine because of all of her allergies but she said there is an antidote if she has a reaction so she said she could take it. She had the first dose of the vaccine on 26Jan2021 and had a bad reaction. She was very dizzy and got sick. They didn't catch it at the vaccination site because they only had the patients wait 15 minutes. Her drive home takes 10-15 minutes. She thought she couldn't drive home because of the dizziness. She got a tightness in her chest and started getting so dizzy that she ran into the living room and slept on the sofa because she couldn't handle it anymore. It was reported that she passed out from about 12:00-15:00. She was completely out. She took a Tylenol right after the shot for dizziness and sick because when she told her healthcare professional about the symptoms, she said to take a Tylenol. She also had shortness of breath on 27Jan2021. This morning (28Jan2021) she had a headache but she was feeling much better. The caller asked if she should get the second dose due to her reaction. The patient stated she has a whole list of allergies that she gave the other agent. The patient stated that she doesn't think she will take the second shot. She also stated she takes Tylenol after the Flu shot so she doesn't get so sick. The patient mentioned that her physician does not know about any of this and said that she received the vaccine at a hospital. She said that she only contacted her doctor to notify her that she was dizzy. She was directed to take Tylenol. She said that she did take Tylenol as directed by the people administering the vaccines too and she did get sick. The patient said that it helped a little and she knows that it was not the Tylenol that caused this. She does not want to get the second shot if she gets sick like this. The patient said that the fact sheet said to call 911. The shot did not hurt her at all, and she did not know that she even received it. She said that the person who administered the vaccine was very good. The outcome of the event headache was recovering, dizziness, shortness of breath recovered on 27Jan2021, Tightness in her chest, passed out was recovered on 26Jan2021 and sick was unknown. Information about Lot/ Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Mastectomy; Metaplastic breast carcinoma; Penicillin allergy; Sulfonamide allergy,,,"['Chest discomfort', 'Dizziness', 'Dyspnoea', 'Headache', 'Impaired driving ability', 'Loss of consciousness']",1,PFIZER\BIONTECH,OT 1023346,FL,72.0,F,"This was scary like waking up with Bells palsy/her neck froze up/when she woke up she could not look up, down, left or right/It was like her neck was frozen or paralyzed, the muscles would not move; the muscles would not move/She was doing anything to loosen the muscles; shooting pain in her head; She was in a lot of pain in her head and neck.; her neurologist confirmed it was a muscle issue; This is a spontaneous report from a contactable consumer who reported for herself, a 72-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration in the left arm, on 21Jan2021 at the age of 72 years, at around 16:00 at a single dose for COVID-19 immunization. Medical history included her left eye had a virus that was finally taken care of back in Mar2020 but took a year and a half to heal. She had 5 surgery on that eye from an unspecified date. Also, her left lymph node got filled with fluid and was swollen but the doctors were not concerned about it. She would see an ENT for this. The patient has been seeing a neurologist who has done brain scans and MRI's due to the loss of peripheral vision do to eye problems. The patient has no allergies and is basically healthy. Concomitant medications include unspecified ""natural stuff"". The reporter stated she had a pretty bad reaction with the vaccine and it took 3 days to get over, her neck froze up. She woke on 22Jan2021 with the frozen neck. She got the first shot on Thursday, 21Jan2021, and on Friday morning, 22Jan2021, when she woke up she could not look up, down, left or right. It was like her neck was frozen or paralyzed, the muscles would not move. Any effort to move her neck would send shooting pain in her head. She applied a heating pad, took Aleve, she took a couple of them, a massager, biofreeze, and stayed in bed. She was doing anything to loosen the muscles. The next morning she was able to look up and down but still not left or right. She did the same thing for treatment that day. On Sunday, 24Jan2021, she was better, was able to move her head 3 of 4 directions. She continued with the treatment she had been using and by Monday, 25Jan2021, her muscles loosed up and her neck worked again. She was sure it is muscles and when she called her neurologist confirmed it was a muscle issue. She was in a lot of pain in her head and neck. The patient was under care for her neck and head and wondered if this happened because this was a weak area, she did not know if related. The patient remarked she was scared to get the second dose due to the problems she had with the first. She heard that the second dose was the one with worse side effects. She was in bed 3 days with this first one. It was reported that the events did not require a visit to Emergency Room, and required visit to physician office. Patient called the neurologist due to the pain and was told to go to acute care to evaluate but she didn't go. The patient stated that this was scary like waking up with Bells palsy and was wondering if she would ever get better. She has never had anything like this happen to her before. She has to be attributed it to the shot. The patient needed guidance on getting the second dose, and had questions about side effects. The outcome of the events was recovering. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/22/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Eye disorder; Eye infection viral (took a year and a half to heal.); Eye operation; Swollen lymph nodes; Vision peripheral decreased,,,"['Headache', 'Joint range of motion decreased', 'Magnetic resonance imaging brain', 'Muscle disorder', 'Musculoskeletal stiffness', 'Neck pain', 'Pain', 'Scan brain']",1,PFIZER\BIONTECH, 1023347,AZ,29.0,F,"Facial nerve pain; This is a spontaneous report from a contactable pharmacist (patient). This 29-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 14Jan2021 16:00 at a single dose on the right arm for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received the first dose on 23Dec2020 13:00 on the left arm. Patient is not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Jan2021 21:00, one week after second shot, the patient started experiencing facial nerve pain. Patient has no medical history of any pain before. Negative etiology from dentist. Patient received 5 day course of prednisone 50 mg, daily which resolved the pain, however, one day after finishing course, the pain returned. It was worse at night with bouts of pain every 30 minutes when trying to sleep. Patient received steroids and carbamazepine 100 mg from internal medicine doctor but this has not helped for this episode. Max doses of Tylenol and ibuprofen have not helped this episode. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/14/2021,01/21/2021,7.0,PUB,,,,,,['Facial neuralgia'],2,PFIZER\BIONTECH, 1023348,OH,52.0,F,"the second injection caused my flare to worsen; fatigue; multiple joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient (not pregnant) received her second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot EK9231), via an unspecified route of administration in right arm on 08Jan2021 10:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included psoriatic arthritis, sub clinical hyperthyroidism and allergy to bees. She had her first dose of bnt162b2 (lot EK5730) on 18Dec2020 in her right arm. No other vaccine in four weeks and no Covid prior vaccination. Concomitant medications included methimazole, meloxicam (MOBIC), apremilast (OTEZLA), atenolol and melatonin. She previously took Ceclor and Biaxin and had drug hypersensitivity. Her psoriatic arthritis was starting to have a flare prior to her first injection. She believed the second injection caused her flare to worsen to the point she had difficulty working due to fatigue and multiple joint pain on 10Jan2021. Tramadol was given as treatment. The events were reported as serious- disability or permanent damage. The outcome of events was not recovered.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/08/2021,01/10/2021,2.0,PVT,METHIMAZOLE; MOBIC; OTEZLA; ATENOLOL; MELATONIN,,Medical History/Concurrent Conditions: Bee sting hypersensitivity; Hyperthyroidism; Psoriatic arthritis,,,"['Arthralgia', 'Condition aggravated', 'Fatigue', 'Impaired work ability', 'Psoriatic arthropathy']",2,PFIZER\BIONTECH, 1023349,TN,57.0,F,"numbness and tingling in mouth and cheek on left side/a little spot on the lip of numbness; numbness and tingling in mouth and cheek on left side; numbness and tingling in mouth and cheek on left side; This is a spontaneous report from contactable nurses. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left deltoid on 27Jan2021 16:30 at a single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus, hypothyroidism, and hypertension. There were no concomitant medications. Patient previously took lisinopril. On 27Jan2021, two minutes after receiving the vaccine, the patient experienced numbness and tingling in mouth and cheek on left side on the same side that she got the vaccine on, so she took 50mg diphenhydramine (BENADRYL), it went away and she slept all night. She then woke up and felt fine, with the exception of a little spot on the lip of numbness on 28Jan2021, so then she took 25mg Benadryl at 11:00 and it was gone all day. In the last 15 minutes her numbness was back and so she took another 25mg Benadryl at 17:00. Patient stated that she knows if this kept continuing she will have to go to the emergency room. In detail, patient had tingling on lips and mouth. The tingling traveled up her left side of the face to the bottom of her nose. Took 50mg of diphenhydramine after she got home. Woke up morning of 28Jan2021 with tingling on her lip, so she took 25 mg at that time. The tingling came back the afternoon and she took another 25mg and another dose before bed. She reports a small area of tingling on her lip remains as of 29Jan2021. She has not take any more diphenhydramine. She does not think it was Bell's Palsy.The reporter considered the event medically significant. Patient inquired if she can take the second dose of the vaccine and that she has done that before with lisinopril (not further clarified). Patient was to receive the second dose on 18Fe2021 or later. Patient did not have anything just right before the vaccine, has had no positive Covid or antibody test prior to the vaccine and no issues with vaccines in the past. The patient has recovered from the events, numbness and tingling in mouth and cheek on 28Jan2021 and outcome of the event, little spot on the lip of numbness was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Hypertension; Hypothyroidism; Type 2 diabetes mellitus,,,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Immediate post-injection reaction', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH, 1023350,NY,94.0,F,"had a fall; This is a spontaneous report from a contactable nurse who reported for her grandmother. A 94-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 29Dec2020, at the age of 94 years, at a single dose for COVID-19 immunization. Medical history included patient was admitted for a broken hip on 19Nov2020, and was then transferred to another institution on 24Nov2020; and patient does have a diagnosis of dementia. There were no prior vaccinations within 4 weeks. There were no concomitant medications. The reporter is a Pfizer Employee calling in regards to the COVID-19 vaccine. She was calling in regards to her grandmother who is in an inpatient rehabilitation facility. On the 16Jan2021, the patient had a fall in the rehab facility and was admitted into the hospital as a part of the facility's fall protocol. The patient was on Lovenox. The patient was admitted into the hospital on 16Jan2021 and was evaluated and discharged on 18Jan2021. At that point on 18Jan2021, Lovenox was stopped. The event was reported as serious per hospitalization. The facility has also been testing residents weekly. The patient was tested negative in the hospital when she had the broken hip and also negative when she went into the hospital for the call. The outcome of the event was recovered on 18Jan2021. No follow-up attempts are possible; information on lot/batch cannot be obtained.; Sender's Comments: The reported fall likely represents an intercurrent medical condition in this 94-year-old female, and is considered unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,12/29/2020,01/16/2021,18.0,SEN,,,Medical History/Concurrent Conditions: Broken hip (admitted for a broken hip on 19Nov2020); Dementia (The patient does have a diagnosis of dementia.),,,"['Fall', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 1023351,,,F,She has concerns that it could be a blood clot as it is on her left side (pain) and near her neck.; Clavicle pain; Swelling of her lymph nodes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Jan2021 the patient experienced clavical pain and swelling of lymph nodes and she had concerns that it could be a blood clot as it was on her left side (pain) and near her neck. The final outcome of the event was unknown.Information about lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/01/2021,,UNK,,,,,,"['Arthralgia', 'Lymphadenopathy']",2,PFIZER\BIONTECH, 1023352,,,M,"Bell's palsy; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bell's palsy from COVID 19 vaccine on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Facial paralysis'],1,PFIZER\BIONTECH, 1023353,,39.0,M,"dead arm; arm pain; This is a spontaneous report from a non-contactable consumer reported for himself. A 39-year-old male patient received bnt162b2, via an unspecified route of administration on 22Jan2021 at 05:00 PM in the right arm (dose: 01) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 at 08:00 PM, the patient had dead arm and patient thought they were exaggerating the extent of the arm pain and thought he was obligated to report. Patient did not receive treatment for the adverse events. The outcome of the events was unknown. No follow up attempts are possible. Information about lot/batch number cannot be obtained",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/22/2021,0.0,UNK,,,,,,"['Musculoskeletal disorder', 'Pain in extremity']",1,PFIZER\BIONTECH, 1023354,CA,67.0,F,"Cellulitis from covid vaccine injection site; I developed injection site pain and swelling post 6 days of vaccination; I developed injection site pain and swelling post 6 days of vaccination; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (COVID 19, Pfizer Covid Vaccine, Solution for injection, Lot number: EL9263), via an unspecified route of administration on left arm on 22Jan2021 09:45 at single dose for covid-19 immunisation. Medical history included hypertension. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included amlodipine, aspirin [acetylsalicylic acid], pregabalin (LYRICA), gelatine hydrolysate (GENACOL), collagen, ginkgo biloba, vitamin D3, vitamin b complex, vit C [ascorbic acid], vit E [tocopherol], fish oil, zinc (Tablet), magnesium (Tablet). On 28Jan2021 at 20:00, the patient developed injection site pain and swelling post 6 days of vaccination and her PCP put her on Keflex for Cellulitis from covid vaccine injection site. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of cellulitis from covid vaccine injection site and Keflex was prescribed. Prior to vaccination the patient was not diagnosed with COVID-19. Outcome of the events was recovering. No follow-up attempts possible. No further information expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/28/2021,6.0,PUB,AMLODIPINE; ASPIRIN; LYRICA; GENACOL; COLLAGEN; GINGKO BILOBA; VITAMIN D3; VITAMIN B COMPLEX; VIT C; VIT E; FISH OIL; ZINC; MAGNESIUM,,Medical History/Concurrent Conditions: Hypertension,,,"['Injection site cellulitis', 'Injection site pain', 'Injection site swelling']",UNK,PFIZER\BIONTECH, 1023355,FL,80.0,M,"Bell's Palsy right side of face; This is a spontaneous report from a contactable physician and consumer. An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via intramuscular first dose on 12Jan2021 14.00 at a single dose for COVID-19 immunisation. The patient medical history included DM (diabetes mellitus), hypertension, CAD (Coronary artery disease) and Atrial Fib (Atrial fibrillation). The patient concomitant medication was not reported. The patient visited physician office and it was reported that patient experienced bell's palsy right side of face on 27Jan2021 06.00. The patient did not receive therapeutic measures for the event. The patient did not have COVID prior vaccination and not tested COVID post vaccination. The patient had not received any vaccine in four weeks (as reported). The outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNt162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/27/2021,15.0,MIL,,,Medical History/Concurrent Conditions: Atrial fibrillation; Coronary artery disease; Diabetes mellitus; Hypertension,,,['Facial paralysis'],1,PFIZER\BIONTECH,OT 1023356,KY,64.0,F,"Anaphylaxis; SOB (shortness of breath)/ difficulty breathing; Chest tightness; dizziness; Wheezing; Anxiety attack; Medication-induced allergic reaction; Blood pressure (BP) increased for 130/89; This is a spontaneous report received from a contactable pharmacist. A 64-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), intramuscular on left arm on 16Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), mopericarditis, anxiety and allergy to antihistamine tabs. The patient's concomitant medications were not reported. It was reported that, the patient was experiencing chest tightness, SOB (shortness of breath), and dizziness on 16Jan2021. 50 mg of Benadryl and 20 mg of famotidine was administered around 14:10. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3 mg of epinephrine was administered at 14:20. EMS was called. Breathing improved. Pulse Ox 100%, HR (heart rate): 68, blood pressure (BP) increased for 130/89. EMS arrived and assumed patient care. ED COURSE: Patient was seen and examined with doctor. Patient developed of SOB, dizziness, wheezing after receiving first shot of Pfizer COVID vaccine. She received Benadryl upon development of symptoms, which actually made them worse given her allergy to antihistamine tabs, but her symptoms improved upon administration of 0.3 IM epinephrine shot. Differential diagnoses include but were not limited to anaphylaxis, anxiety attack, medication-induced allergic reaction on 16Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. The patient visited emergency room/ department or urgent care due to the events. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19, since the vaccination. The events were assessed as non-serious by the reporter. Therapeutic measures were taken as a result of events. The outcome of the events was reported as recovered on an unspecified date in Jan2021.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The treatment with Benadryl most likely contributed to the events as the patient is known allergic to antihistamine tabs. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/16/2021,01/01/2021,,OTH,,,Medical History/Concurrent Conditions: Anxiety; Drug allergy; Hypertension; Myopericarditis,,,"['Anaphylactic reaction', 'Anxiety', 'Blood pressure increased', 'Chest discomfort', 'Dizziness', 'Dyspnoea', 'Hypersensitivity', 'Physical examination normal', 'Wheezing']",1,PFIZER\BIONTECH,OT 1023357,IN,85.0,F,"rheumatoid and osteoarthritis. Always have some pain but it increased dramatically; rheumatoid and osteoarthritis. Always have some pain but it increased dramatically; This is a spontaneous report from a contactable nurse (patient). An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: not reported), via an unspecified route of administration on right arm on 29Jan2021 08:00 at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, ongoing osteoarthritis, CAD (coronary artery disease), hypertension, GERD (gastrooesophageal reflux disease), osteoporosis, lumbar stenosis, lumbar degenerative disc and Allergies: Sulfa. Concomitant medication included carvedilol (COREG), prednisone, methotrexate, adalimumab (HUMIRA), fluoxetine hydrochloride (PROZAC) and risedronate sodium (RISEDRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not diagnosed with COVID-19 prior to vaccination. On 29Jan2021, 12:00 patient had rheumatoid and osteoarthritis. Always have some pain but it increased dramatically and almost unbearably. The patient pain med did help some. Lasted about 11 hours. The seriousness criteria were considered as non-serious. Since the vaccination, the patient been not tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect drug on reported Rheumatoid Arthritis aggravated cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,PVT,COREG; PREDNISONE; METHOTREXATE; HUMIRA; PROZAC; RISEDRIN,Osteoarthritis (osteo arthritis); Rheumatoid arthritis,Medical History/Concurrent Conditions: Coronary artery disease (cad); GERD; Hypertension; Lumbar disc degeneration; Lumbar spinal stenosis (Lumbar Stenosis); Osteoporosis; Sulfonamide allergy (Allergies: Sulfa),,,"['Osteoarthritis', 'Rheumatoid arthritis']",1,PFIZER\BIONTECH, 1023358,CA,,F,"encephalitis-like symptoms; Hearing loss; memory loss; parathesias; visual disturbances; taste disturbances; dizziness; Lsided chest pain; staggering; elevated SBP 190-200; severe L-sided chest tightness; pre-syncope; elevated BP; DDimer was elevated; fell; intermittent memory lapses; nausea episodes; cant smell that last 1-2 hrs; L neck /head pain; L neck /head pain; Left axilla lymphadenopathy; rhinitis; lightheaded/lightheadedness; had an episode of pain all over; SOB; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration from on 19Dec2020 at a single dose for COVID-19 immunization. Medical history included ovarian cancer at age 29, food allergy to clams and escargot, and allergy to sulfa. The patient's concomitant medications were not reported. The patient previously took bactrim and experienced allergies. On 19Dec2020, immediately after vaccine had rhinitis, lightheaded, given Zyrtec and water and observed for a duration of 30 min. Three hours postvaccination on 19Dec2020, at home had an episode of pain all over and SOB (shortness of breath). 3 days later (22Dec2020), patient had L (left) neck /head pain and left axilla lymphadenopathy. On 23Dec2020, she fell in the shower. On the same day (23Dec2020) the patient had intermittent memory lapses, lightheadedness, nausea episodes, can't smell that last 1-2 hours a few times a day. Symptoms worsened on 03Jan2021, with severe L-sided chest tightness, pre-syncope, was seen in the ER with elevated BP. DDimer was elevated, CT Scan of Chest/Abdomen showed L axilla lymphadenopathy, negative for PE. CBC, Electrolytes WNL (within normal limits), still on 03Jan2021. Observed in ER for 7 hrs. and then discharged home. Intermittent symptoms continued. On 08Jan2021, patient had another severe episode while at work. She was noted to be staggering, and again was complaining of left-sided chest pain. She was taken to the ER by her colleagues on 08Jan2021 and noted to have elevated SBP 190-200. On 08Jan2021, patient underwent CT head negative, MRI negative, w/u (workup) for pheochromocytoma negative and COVID negative. She was started on prednisone and Norvasc and discharged home. She continues to have intermittent episodes however they have decreased in intensity and last for about 1 hour. She described her symptoms as encephalitis-like symptoms. These include memory loss, paresthesia, visual disturbances, hearing loss, taste disturbances, and dizziness. These symptoms when severe have been incapacitating. She had been hospitalized for a neurological and infectious work up (including Brain MRI and multiple COVID tests) but no diagnosis has been yet identified. This symptom kcomplex (unspecified) has persisted to now. She has not received the second dose of vaccine. She is asking how long mRNA, the lipid nanoparticles and the protein spike lasts in the body. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the implied temporal association. However, underlying medical conditions may provide the alternate explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,U,12/19/2020,12/19/2020,0.0,UNK,,,"Medical History/Concurrent Conditions: Food allergy (food allergies (clams, escargot)); Ovarian cancer (age 29); Sulfonamide allergy (Allergies to Bactrim/Sulfa)",,,"['Amnesia', 'Anosmia', 'Blood electrolytes', 'Blood pressure increased', 'Blood pressure measurement', 'Blood pressure systolic increased', 'Blood test', 'Chest discomfort', 'Chest pain', 'Computerised tomogram', 'Deafness', 'Dizziness', 'Dyspnoea', 'Encephalitis', 'Fall', 'Fibrin D dimer increased', 'Full blood count', 'Gait disturbance', 'Headache', 'Laboratory test', 'Lymphadenopathy', 'Magnetic resonance imaging', 'Magnetic resonance imaging brain', 'Memory impairment', 'Nausea', 'Neck pain', 'Pain', 'Paraesthesia', 'Physical examination', 'Presyncope', 'Rhinitis', 'SARS-CoV-2 test', 'Taste disorder', 'Visual impairment']",1,PFIZER\BIONTECH, 1023359,OK,,F,"Seizure; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization. Medical history included being immunocompromised from an unknown date and was taking a lot of medications. Concomitant medication includes a lot of medications (unspecified). The patient was previously vaccinated with the first dose of BNT162B2 on an unspecified date. It was reported that the patient received the second dose of COVID-19 vaccine on the afternoon of 28Jan2021 and experienced seizure. The reporter wanted to know if he needed to seek a doctor early this morning for the patient. The outcome of the event was unknown. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/28/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Immunocompromised (She is taking a lot of medications and she is immunocompromised.),,,['Seizure'],2,PFIZER\BIONTECH, 1023360,GA,38.0,M,"blood pressure (1:10 PM): 143/92; Syncopal episode; Patient was pale; Diaphoretic; feeling light-headed; This is a spontaneous report from a contactable nurse. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot: EL8982), intramuscularly into the left arm on 27Jan2021 13:00 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 27Jan2021 13:05 patient had a syncopal episode but regained consciousness immediately and was assessed for injury and other reactions. The patient was pale, diaphoretic and reported feeling light-headed on 27Jan2021 13:05. The patient underwent lab tests and procedures on 27Jan2021 which included blood pressure measurement (units unspecified): 143/92 (1:10 pm), 125/90 (1:15 pm), 131/89 (1:20 pm), 135/81 (1:25 pm) and 130/89 (while standing upright); body temperature (unit unspecified): 98.6 (1:10 pm), 99.0 (1:25 pm) and 98.6 (oral; while standing upright); heart rate (unit unspecified): 74 (1:10 pm), 81 (1:15 pm), heart rate: 85 (1:20 pm), 79 (1:25 pm), 72 (while standing upright); oxygen saturation: 96% (1:10 pm), 99% (1:15 pm), 97% (1:25 pm), 96% (while standing upright); respiratory rate (unit unspecified): 20 (1:10 pm), 20 (1:15 pm), 20 (1:20 pm), 20 (1:25 pm), 18 (while standing up). Outcome of events recovered on an unspecified date.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,OTH,,,,,,"['Dizziness', 'Hyperhidrosis', 'Loss of consciousness', 'Pallor', 'Syncope']",UNK,PFIZER\BIONTECH,OT 1023361,CA,75.0,F,"tingling of lip and face; tingling of lip and face; numbness on left side of face/numbness was not in her throat but it was on her neck behind her ear; blood pressure spiked; tired; she didn't sleep well; Chest pain; This is a spontaneous report from a contactable nurse (patient herself). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: lot number: E19262, via an unspecified route of administration, left arm, on 26Jan2021 10:00 at a single dose to not get Covid and to protect others around her. Medical history included mini stroke at least 8-10 years ago and neuropathy in face from ministroke. Concomitant medication included gabapentin for neuropathy in face from ministroke. The patient had no prior vaccinations (within 4 weeks). The patient previously took pregabalin (LYRICA): but was changed to gabapentin. On 26Jan2021, the patient experienced tingling of lip and face, numbness on left side of face, blood pressure spiked and chest pain. On 27Jan2021, the patient experienced tired. The events were described as: After getting the vaccine, she experienced tingling of the lip and left side of her face. She had numbness on the left side of her face. The numbness was not in her throat but it was on her neck behind her ear. Her blood pressure spiked. She drover herself to the emergency room. Her blood pressure was 160 something over 101. She was unable to specify the exact number. Then her blood pressure decreased to 104 over 80 something and it increased to 202 systolic. She was unable to specify the reading. She was tired on 27Jan2021 because she didn't sleep well in the hospital. She signed out against medical advice. The patient had a full work up to include a CT scan, MRI and doppler: results were not provided (unknown results). The patient wanted to know if recommendations were made in regard to taking the second dose if they have had adverse events. The patient was hospitalized from 26Jan2021 to 27Jan2021 (1 day) for tingling of lip and face, numbness on left side of face and blood pressure spiked. Chest pain was considered medically significant by the reporter. The outcome of she didn't sleep well was unknown. The patient was recovering from tingling of lip and face and tired. The patient has not recovered from numbness on left side of face. The patient recovered from blood pressure spiked and chest pain on 27Jan2021.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/26/2021,01/26/2021,0.0,OTH,GABAPENTIN,,Medical History/Concurrent Conditions: Facial nerve disorder; Stroke (at least 8-10 years ago),,,"['Blood pressure increased', 'Blood pressure measurement', 'Chest pain', 'Computerised tomogram', 'Fatigue', 'Hypoaesthesia', 'Magnetic resonance imaging', 'Paraesthesia', 'Paraesthesia oral', 'Poor quality sleep', 'Ultrasound Doppler']",1,PFIZER\BIONTECH, 1023362,,71.0,F,"dental pain; fatigue; headache; loss of taste; loss of smell; body aches; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (BNT162B2), via intramuscularly on 13Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing ankylosing spondylitis and potentially being exposed to COVID. The patient's concomitant medications was not reported. Patient began to have symptoms of COVID on 16Jan2021. The symptoms include Body aches, headache, loss of taste, loss of smell, dental pain, and fatigue. Hence on 22Jan2021 the patient hospitalized and same day had discharge, the patient had, blood sampling, X-ray, oxygen, and intravenous fluid. The patient underwent lab tests and procedures which included blood test: unknown result on 22Jan2021, x-ray: unknown result on 22Jan2021. The outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/13/2021,01/16/2021,3.0,UNK,,Ankylosing spondylitis,Medical History/Concurrent Conditions: Exposure to COVID-19,,,"['Ageusia', 'Anosmia', 'Blood test', 'Fatigue', 'Headache', 'Pain', 'Toothache', 'X-ray']",UNK,PFIZER\BIONTECH,OT 1023363,WA,37.0,F,"Anaphylaxis; myocardial infarction; This is a spontaneous report from a contactable healthcare professional. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in the left arm on 04Jan2021, at 15:45 as first single dose for COVID-19 immunization. Medical history included hypothyroidism, depression, anxiety and known allergy to nickel from unknown dates. Concomitant medication included thyroid (ARMOUR THYROID), liothyronine sodium (CYTOMEL), bupropion (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO). On 04Jan2021, at 15:45, the patient experienced anaphylaxis and myocardial infarction, which were serious as they caused hospitalization, disability, and were life threatening. The patient was hospitalized for three days. Therapeutic measures were taken as a result of anaphylaxis and myocardial infarction, noted as lots of medications, intensive care unit (ICU) stay, continued unspecified medications. No covid was noted prior to vaccination and no covid test post vaccination was reported. The outcome of anaphylaxis and myocardial infarction was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events anaphylaxis and myocardial infarction cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,3.0,Yes,N,01/04/2021,01/04/2021,0.0,OTH,ARMOUR THYROID; CYTOMEL; BUPROPION; LEXAPRO,,Medical History/Concurrent Conditions: Anxiety; Depression; Hypothyroidism; Nickel sensitivity,,,"['Anaphylactic reaction', 'Myocardial infarction']",1,PFIZER\BIONTECH, 1023364,UT,72.0,F,"Blood pressure 170/84; lost ability to speak intelligibly; foggy; headache; scratchy throat; fatigue; Body aches; This is a spontaneous report from a non-contactable consumer. A 72-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 28Jan2021, 11:00 AM (lot number:EL3249), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in Doctor's office/urgent care. The patient medical condition included right Bundle Branch Block, cardiac from an unknown date and unknown if ongoing. The patient had no known allergies. The patient concomitant medication included paracetamol (TYLENOL) and Upgraid. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 06Jan2021, 02:00PM (lot number: EL3249) at the age of 72 years for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for covid-19. Twenty-four hours after vaccine received, on 29Jan2021 at 03:00 PM, the patient suddenly lost ability to speak intelligibly. The patient stated ""I was completely aware though a little ""foggy"". Blood pressure 170/84. Friend present thought I was having a TIA and called 911. Ambulance came. Within 25 minutes, my ability to speak returned slowly. By the time I got to the ER, (45 minutes after onset), my ability to speak had mostly returned."" Many blood labs were drawn, CT of head done, MRI of head done. EKG done. No cause of incident or evidence of TIA seen. After 5 hours, the patient was discharged with orders to come back if symptoms reoccurred. The patient had a headache, scratchy throat, fatigue and body aches in 2021. Since then the patient had a variety of tests, labs and Dr. visits. Blood pressure has been higher than her normal of 120/80, at intervals during the day in 2021. Since no evidence of TIA has been found, the patient was wondering if there have been any other reports of this loss of speaking ability (aphasia) occurring with any other vaccine recipients. The patient received treatment for the events. The consumer considered the events as non-serious. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,OTH,TYLENOL,,Medical History/Concurrent Conditions: Right bundle branch block,,,"['Aphasia', 'Blood pressure increased', 'Blood pressure measurement', 'Blood test', 'Computerised tomogram head', 'Electrocardiogram', 'Fatigue', 'Feeling abnormal', 'Headache', 'Magnetic resonance imaging brain', 'Pain', 'Throat irritation']",2,PFIZER\BIONTECH, 1023365,,,U,"When got up I passed out; blood pressure shoot up to 180 over 100; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient took the covid dose yesterday and after he/she took it, he/she sat there for few minutes and then when he/she got up he/she just passed out. The patient mentioned that they called the code blue in the hospital, they tried to, they were going to, he/she doesn't know what they were going to do but they ended up taking the patient to the emergency room where they ran every test possible blood work they did chest X-ray, they did EKG. The patient stated that the only thing that was consistent was that after the vaccine his/her blood pressure shot up to 180 over 100 and they were trying to get it down, they gave the patient some fluid (unspecified) which stayed for over two hours. The patient added that he/she have never had any blood pressure issues, as he/she was not even on any medications. The patient mentioned that he/she was now afraid to take the second dose. The events occurred on 27Jan2021 with outcome of unknown. Unknown results for blood work, EKG and chest X-ray. The reporter considered the events serious per hospitalization on 27Jan2021. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,,,,,,"['Blood pressure increased', 'Blood pressure measurement', 'Blood test', 'Chest X-ray', 'Electrocardiogram', 'Loss of consciousness']",1,PFIZER\BIONTECH, 1023366,MI,84.0,F,"numbness and heaviness in her whole arm/given in her right upper arm and that was the arm that was numb and heavy feeling; heaviness in her whole arm / discomfort at the site of injection; This is a spontaneous report from a contactable nurse (patient). An 84-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1283), via an unspecified route of administration in the right upper arm on 21Jan2021 at 1:30 or 2pm at a single dose for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medication included medication for high blood pressure. The patient received the first dose on 21Jan2021 and has experienced numbness and heaviness in her whole arm on 25Jan2021. She was calling because she wanted to know what to should she do about it. She was leery about getting the second dose. The patient was asking if this is normal, it doesn't feel normal. She has called her doctor and was waiting to hear back from them. On 21Jan2021, on the day she got the injection, she noticed discomfort at the site of injection but that only lasted that day and that has resolved. Now she only has the heaviness and numbness, this started on 25Jan2021, 4 days later and was still ongoing. The vaccine was given in her right upper arm and that was the arm that was numb and heavy feeling. Outcome of the events was not recovered. The event numbness and heaviness in her whole arm was reported as serious (medically significant).; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events vaccination site hypoaesthesia and vaccination site discomfort cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,UNK,,Blood pressure high,,,,"['Vaccination site discomfort', 'Vaccination site hypoaesthesia']",1,PFIZER\BIONTECH, 1023367,FL,74.0,F,"she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; right breast hurts; it radiates around to her back; Fatigue; and can't lift or pull anything and it really, really hurts; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included sinus disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received a flu shot on an unspecified date. Consumer is calling about the Pfizer COVID-19 vaccine, and says she just spoke to a nurse who told her to call and find out if her experience for what she had after her first shot on Friday of the past week had been reported before. She says that on Saturday (23Jan2021), she woke up and her right breast hurt, there is something in there, it radiates around to her back, along with having fatigue. She says she was told to see if anyone else reported this, she expected normal stuff like, flu stuff, this is not that. She says she is on her way to urgent care to have that looked at. She asks if condition persists, she is supposed to get her second dose on 12Feb, does she get it? She got her first dose last Friday (22Jan2021) then woke up Saturday and can't lift or pull anything and it really, really hurts. She says to add to this, which she talked to two doctors (docs) who said it was unrelated, that night she had a cut to the top of the roof of her mouth that had uncontrollable bleeding, she went to the emergency room for that and got a shot to help her coagulate blood, and will be seeing an ENT so hopefully that will be under control. No further details provided about shot to help her coagulate blood. She got the flu shot but that was Thanksgiving, way back, not recent. She is going to get her sinuses checked out, they did a CAT scan yesterday, and is going to the doctor for that 1Feb. She is concerned that the breast pain started last Saturday and is still really painful, she doesn't know why all of a sudden that happened, so she is going to the urgent care to see if they can do something for it, and will be getting an appointment with her OBGYN. For her right breast hurting, she took Tylenol and Ibuprofen, that is all she has done. Tylenol, LOT: PPAO33, EXP: Sep2022. Ibuprofen, LOT: 113132. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on 27Jan2021. Therapeutic measures were taken as a result of she had a cut to the top of the roof of her mouth that had uncontrollable bleeding she had a cut to the top of the roof of her mouth that had uncontrollable bleeding and right breast hurts. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/23/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Sinus disorder,,,"['Back pain', 'Breast pain', 'Computerised tomogram', 'Fatigue', 'Mouth haemorrhage', 'Mouth injury', 'Pain']",1,PFIZER\BIONTECH, 1023368,,,U,"cannot get flu shot, allergic to them; Initial information was received on 26-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (patient) via social media. This case involves a patient (unknown demographics) who could not get INFLUENZA VACCINE as he/she was allergic to it (allergy to vaccine). It was unknown if the patient had any concomitant disease or risk factor. The patient's medical history, past medical treatment(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed allergy (allergy to vaccine) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if there were lab data/results available. It was unknown if the patient experienced any additional symptoms/events. The details medication and reason for taking the medicine were not provided. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome was unknown for the event. There will be no information available on batch number for this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Allergy to vaccine'],UNK,UNKNOWN MANUFACTURER,OT 1023372,NJ,34.0,F,"INCREASED HEART RATE; NUMBNESS; TINGLING; SLURRED SPEECH; CONFUSION; OUT OF BREATH; A spontaneous report has been received from a consumer. The report concerns a female patient (age 31 years, height 60 in, weight 160 lb). No medical history was reported. Concomitant medication included Cosentyx for psoriatic arthritis, autoimmune condition. The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) once/single administration, via nasal route, for prevention on 03-JAN-2021. On 04-JAN-2021, the patient experienced increased heart rate (preferred term: Heart rate increased), numbness (preferred term: Hypoaesthesia), tingling (preferred term: Paraesthesia), slurred speech (preferred term: Dysarthria) and confusion (preferred term: Confusional state). On an unknown date, the patient experienced out of breath (preferred term: Dyspnoea). At the time of reporting, the event of out of breath was ongoing. At the time of reporting, the event of increased heart rate was improving. The outcome of the event(s) of numbness, tingling, slurred speech and confusion was unknown. The events were considered non-serious. Laboratory values are available.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/03/2021,01/04/2021,1.0,UNK,,,Comments: None,,,"['Confusional state', 'Dysarthria', 'Dyspnoea', 'Heart rate increased', 'Hypoaesthesia', 'Paraesthesia']",UNK,"MEDIMMUNE VACCINES, INC.",OT 1023374,AZ,78.0,F,"Doesn't recognize Husband or family; Not eating much; Nausea; Headache; Diarrhea; Sleeping 24hs a day; A spontaneous report was received from a health care professional concerning a 78-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed diarrhea, nausea, headache, sleeping 24 hours a day, not eating, and didn't recognize husband or family. The patient's medical history included Alzheimer's disease. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine sodium. On 08 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Jan 2021, the reporter states the patient went into a sharp decline, diarrhea, nausea, headache and sleeping 24 hours a day. A few days later, the patient was not eating much and did not recognize her husband or family. Treatment for the event included paracetamol, emergency room visits, and nursing care center placement. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, developed diarrhea, nausea, headache, sleeping 24 hours a day, not eating, and didn't recognize husband or family, were considered unknown.; Reporter's Comments: This case concerns a 78-year-old, female patient with a medical history of Alzheimer's disease, who experienced unexpected events of diarrhea, hypersomnia, decreased appetite, confusional state and expected events of nausea and headache. The events of diarrhea, nausea, headache and hypersomnia occurred 5 days after the first dose of mRNA-1273 (Lot 025J20-2A) and, the events of decreased appetite and confusional state occurred unspecified number of days later. Treatment for the event included paracetamol, emergency room visits, and nursing care center placement. Very limited information regarding this event has been provided at this time. Alzheimer's disease is a confounding factor too. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested.",Not Reported,,Not Reported,Yes,,Yes,U,01/08/2021,01/12/2021,4.0,UNK,SYNTHROID,,Medical History/Concurrent Conditions: Alzheimer's disease (About 3 years ago got diagnosed),,,"['Confusional state', 'Decreased appetite', 'Diarrhoea', 'Headache', 'Hypersomnia', 'Nausea']",1,MODERNA,OT 1023375,IA,35.0,F,"Became unresponsive; Looked like having a seizure; Felt light headed; BP extremely low; Profusely sweating; Heart rate extremely low; A spontaneous report was received from a pharmacist, concerning a 35-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt light headed, became unresponsive, looked like having a seizure, BP extremely low, heart rate extremely low, and profusely sweating. The patient's medical history, as provided by the reporter, included high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included hydrochlorothiazide/lisinopril. On 29 Jan 2021, five minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 025L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 29 Jan 2021, the patient felt light-headed five minutes after receiving the vaccine. He then became unresponsive but was breathing and had a pulse. The reporter stated it looked like the patient was having a seizure; his eyes rolled upward, his left arm shook, and he did not respond to touch or voice. It was reported that 911 was immediately called and responded within a couple of minutes. The patient's blood pressure and heart rate were extremely low, and he was profusely sweating. The reporter stated that the patient came to and still felt very light-headed. The patient was then taken to the emergency department. Medical tests and laboratory results were unknown, but the reporter stated that a magnetic resonance imaging (MRI) was possibly performed. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, became unresponsive and looked like having a seizure, were resolved on 29 Jan 2021. The outcome for the events, felt light headed, BP extremely low, heart rate extremely low, and profusely sweating, was unknown.; Reporter's Comments: This case concerns a 35-year-old, female, with medical history of high blood pressure, who experienced a serious unexpected event of syncope, seizure, and non-serious unexpected events of dizziness, hypotension, hyperhidrosis, and heart rate decreased. The events occurred 1 day (5 min) after mRNA-1273 (Lot# 025L20A). Treatment information was not provided. Concomitant medications included: hydrochlorothiazide/lisinopril. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,UNK,LISINOPRIL/HCTZ,Hypertension,,,,"['Blood pressure measurement', 'Dizziness', 'Heart rate', 'Heart rate decreased', 'Hyperhidrosis', 'Hypotension', 'Seizure', 'Syncope']",1,MODERNA,OT 1023471,,,M,"tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable Pharmacist. A male patient of an unspecified age (Age: 38; Unit: Unknown) receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for covid after the first dose of the covid 19. Caller wanted to know if the patient needed to wait to get the second dose. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. However, no complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection. Further information like COVID infection date needed for a full meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1023475,,,F,The Patient received the Pfizer-BioNTech COVID-19 Vaccine first dose but tested positive for covid 2 days after; The Patient received the Pfizer-BioNTech COVID-19 Vaccine first dose but tested positive for covid 2 days after; This is a spontaneous report from a contactable consumer. This consumer reported for her 76-year-old mother who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation. Relevant history and concomitant drugs were unknown. The patient was tested positive for COVID 2 days after the vaccination. Outcome of the event was unknown. The information on the LOT/Batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1023477,,,F,"patient resulted positive to COVID-19 after vaccination; patient resulted positive to COVID-19 after vaccination; This is a spontaneous report from a contactable other hcp (patient). This 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 27Jan2021 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient resulted positive to Covid-19 after vaccination on 27Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1023478,OH,,F,"she had bumps all over her body and below her eyes which appeared swollen.; itchiness; At 10:30 she started feeling sick; raised humps on her hands and arms/ throughout the evening the bumps went to different places on her body; This is a spontaneous report from a contactable consumer who reported for herself. An 82-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on 21Jan2021 for Covid-19 immunization. Medical history was not reported. Concomitant medications included gabapentin and paracetamol (TYLENOL). On 25Jan2021 around 5:30-6 p.m, the patient noticed raised bumps on her hands and arms, and throughout the evening the bumps went to different places on her body. At 10:30 she started feeling sick and noticed that she had bumps all over her body and below her eyes which appeared swollen. She went to the ER because the itchiness was unbearable. In the ER, they gave her Prednisone and a Benadryl, in which she broke out again after taking the medication. The ER sent her home with a prescription for Prednisone and Claritin. She slept all the following day and she normally only takes Gabapentin and Tylenol for her medication. Patient wanted to know that if these reactions have been reported, If she should take the second injection and have the reactions been reported days later. The outcome of the events was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/25/2021,4.0,UNK,TYLENOL; GABAPENTIN,,,,,"['Eye swelling', 'Malaise', 'Pruritus', 'Rash papular']",1,PFIZER\BIONTECH, 1023482,MA,,U,"tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist from a Pfizer-sponsored program. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 on an unspecified date. It was reported that the patient needed to take monoclonal antibodies (bamlanivimab (MANUFACTURER UNKNOWN)) before the second dose. However, the patient tested positive after the first dose and so the pharmacist was questioning if it is okay for the patient to take the antibodies before the second dose. The patient underwent lab tests and procedures, which included COVID-19 test: positive on an unspecified date. The clinical outcome of tested positive for COVID-19 was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: Limited information precludes a medically meaningful assessment of the case. Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1023483,CA,76.0,F,"BP;A bit high for her; Anaphylactic reaction; back rash; burning sensation; swollen face; itchy back; Back getting hot; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 76-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date not reported) , via an unspecified route of administration on the left arm on 27Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included anaphylaxis with contrast media (Biaxin and eucalyptus), allergies: latex, antihistamines, sulfa, olive trees; allergic reactions to iodine, asthma, cardiac arrest, has a pacemaker; all from unknown dates. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), vitamin D3, levocabastine hydrochloride (ZYRTEC), iron, diltiazem, salbutamol sulfate (ALBUTEROL). The patient previously took Biaxin, eucalyptus and tiger balm and experienced anaphylaxis, Cipro, sucralfate, adrenaline (EPIPEN), corticosteroid and experienced allergies. The patient previously received Shingles vaccine on Nov2020 for immunization and experienced intermittent itchy back sensation. The patient reported that after vaccine reaction today (27Jan2021) - back rash, burning sensation, swollen face. It was further reported that the patient experienced potential anaphylactic reaction; 15 minutes after the administration she got her back getting hot and Itchy and a rash breakout. It was also reported that the patient's BP was a bit high for her on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: a bit high for her on an unspecified date. Therapeutic measures were taken as a result of anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot which included treatment with Benadryl (Took one 25 mg Benadryl. Then she took another 25 mg Benadryl); it was reported that 30 minutes later symptoms started to subside. The patient recovered from anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot on 27Jan2021, while the outcome of BP was a bit high for her was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,UNK,LEVOTHYROXIN; VITAMIN D3; ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]; IRON; DILTIAZEM; ALBUTEROL [SALBUTAMOL SULFATE],,Medical History/Concurrent Conditions: Allergy to plants; Anaphylactic reaction to drug; Asthma; Cardiac arrest (at age 58); Drug allergy; Iodine allergy; Latex allergy; Pacemaker complication; Sulfonamide allergy,,,"['Anaphylactic reaction', 'Blood pressure measurement', 'Burning sensation', 'Feeling hot', 'Hypertension', 'Pruritus', 'Rash', 'Swelling face']",1,PFIZER\BIONTECH, 1023485,,,F,"anaphylaxis; she didn't feel well; she felt weak; felt like throat was closing; Her heartrate was 113; low grade headache; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter was not sure if patient made her symptoms worse with her attitude, but in the first 5 minutes (27Jan2021), patient reported she didn't feel well, she felt weak, and felt like throat was closing. She was referred to the ED (emergency department) for anaphylaxis and given 1 dose of epinephrine. The ED said they do not know if it was an anaphylactic reaction. Her heart rate was 113 (27Jan2021). After that, she rested for the rest of the day and now has a low grade headache and some of the typical side effects (unspecified). Reporter asked for the recommendation for the second dose. The events were not serious as per reporter. Therapeutic measures taken as a result of the event anaphylaxis. The outcome of the event anaphylaxis, didn't feel well, felt weak, felt like throat was closing, heart rate was 113, and low grade headache was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug.. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,,,,,,"['Anaphylactic reaction', 'Asthenia', 'Headache', 'Heart rate', 'Heart rate increased', 'Malaise', 'Throat tightness']",1,PFIZER\BIONTECH, 1023486,,,F,"low grade head ache; GI c/o; anaphylaxis; Difficulty breathing; Lightheaded; throat felt like swollen/Throat getting narrower; did not feel well; hr 112; nausea; Didn't feel right; This is a spontaneous report from a contactable Physician who reported for a patient (staff member). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of vaccine and during 15 min observation window did not feel well. It was later reported by the same reporter that within 3-5 minutes after injection the patient didn't feel right. Felt lightheaded, wasn't there. Having difficulty breathing and felt throat was getting narrower. Stated throat felt like swollen and heart rate was 112. Went up to people at vaccine center, was given Benadryl and sent to the Emergency Room (ER). Told she was having anaphylaxis. ER was not convinced of anaphylaxis, but was given epinephrine. Ultimately was given epinephrine although they stated that unclear if anaphylaxis or not. Was given 50mg of Benadryl. Was given Zofran for nausea. 'Today' (28Jan2021) had low grade head ache and GI c/o (gastrointestinal complaints of). Had no previous issues with vaccine or drug reaction. Has comorbidities. The reporter was seeking recommendations for the second COVID-19 Vaccine. The outcome of the events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and safety profile of suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,,,,,,"['Anaphylactic reaction', 'Dizziness', 'Dyspnoea', 'Feeling abnormal', 'Gastrointestinal disorder', 'Headache', 'Heart rate', 'Heart rate increased', 'Malaise', 'Nausea', 'Pharyngeal swelling']",1,PFIZER\BIONTECH, 1023491,CA,,F,"patient was positive with covid-19 after the first dose; patient was positive with covid-19 after the first dose; This is a spontaneous report from a Pfizer-sponsored program by a contactable consumer (patient). This 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL1284), via an unspecified route of administration at single dose on 06Jan2021 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was positive with Covid-19 after the first dose in Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in Jan2021. The event was described as follows: She received the first dose of Covid-19 vaccine on 06Jan2021. She had mild symptoms after receiving the vaccine. Since receiving the first dose she contracted Covid. She has completed her quarantine period. She was due to receive the second dose last Monday. The county health department does not recommend that she receive the second dose since she has the natural antibodies and she will have to wait 90 days to get the second dose. Her doctor says she needs to get the second dose. What is Pfizer's position as far as waiting since she tested positive for Covid? She barely experienced symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1023494,,43.0,M,"anaphylaxis; This is a spontaneous report from a non-contactable healthcare professional (patient himself). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylaxis in Jan2021. The outcome of the event was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/01/2021,,UNK,,,,,,['Anaphylactic reaction'],UNK,PFIZER\BIONTECH, 1023503,NC,81.0,M,"lost about 10 lbs; short of breath; chills; tested positive for Covid 19; tested positive for Covid 19; feel weak/doesn't feel good; sinuses were terrible and he still has it today. Like when he got up and got to the sink to blow his nose it was like a hard bloody scab that came out, blood tinge.; temperature went to 99.1/Temperature increased; he had the aching, pain, his muscles; headache; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). An 81-years-old male patient received first dose of bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration in Left Arm on 14Jan2021 at SINGLE DOSE for Covid-19 immunization. The patient's medical history was none. The patient's concomitant medications were not reported. The patient had never had any sickness. On 14Jan2021 he got his first dose and before the vaccine his temperature was normal. When he got the shot, before leaving his temperature went to 99.1, they told him don't be surprised if it goes to 100. He was supposed to go back for his second dose on 04Feb2021. When he got home that same day he began to feel weak, he has been in bed for 2 weeks now. He tested positive for Covid 19 on 22Jan2021. He described the test was a Long stick in the right nostril down to the throat. It was positive, he took the test on 22Jan2021 and on 25Jan2021 is when they called him with results. He just did not feel good. He was wondering if he should take the second shot on 04Feb2021. He had researched on Google and it said not to take it, if you've had the flu. On 14Jan2021 was when he experienced the increase in temperature and weakness on the same day. He did not get real bad, but felt those symptoms for a few days and got worse. He went out in Public the next day with no problem. He did go to grocery store and did wear a mask. He had lost about 10 lbs Weight. Temperature Increased: He had a fever last night (27Jan2021). He was over the worst and he would live now (28Jan2021). He was hoping to get 24 hours without a fever, but yesterday (27Jan2021) it was a low 99 point something and he had chills. Weakness: Right now (28Jan2021) he was strong but when getting through breakfast and this conversation he would be short of breath and weak. The weakness was the biggest problems. On the 14Jan2021 it was not bad, he didn't think nothing of it but he didn't feel good, he had the aching, pain, his muscles, headache, his sinuses were terrible and he still has it today. Like when he got up and got to the sink to blow his nose it was like a hard bloody scab that came out, blood tinge. The outcome of event tested positive, ""sinuses were terrible"", short of breath, Muscle ache, headache, lost about 10 lbs and chills was unknown, of event weakness was not recovered, temperature increased was recovered with sequel on 27Jan2021. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Asthenia', 'Body temperature', 'Body temperature increased', 'COVID-19', 'Chills', 'Drug ineffective', 'Dyspnoea', 'Headache', 'Myalgia', 'Sinus disorder', 'Weight', 'Weight decreased']",1,PFIZER\BIONTECH, 1023504,NJ,,M,tested positive; tested (SARS-CoV-2 test) positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient stated he got the first dose and tested (SARS-CoV-2 test) positive. Outcome of the event was unknown. Information about Batch/Lot number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1023505,FL,,F,"Positive COVID-19 test with symptoms; Positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 20Jan2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, in 2021, the patient experienced headache, became nauseous and was tested positive. She wanted to know if she could continue with her second dose. Clinical outcome of the events was unknown at time of this report. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1023507,NY,50.0,F,"Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmares; euphoria; insomnia; waking up often red eye; Nasal Swab positive; Nasal Swab positive; This is a spontaneous report from a contactable nurse reported for herself. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot#Ek5730, on 28Dec2020 04:00 PM at single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. On 31Dec2020 the patient tested positive for the SARS-COV-2 virus (via nasal swab). The outcome of the event was unknown. On 27Jan2021 the patent experienced chills, lymph nodes swollen on chest, lump in throat, muscle aches pain at injection site, nightmares, euphoria, insomnia and waking up often red eye. The outcome of these events was reported as recovered and no treatment received. Lab data included Polymerase chain reaction: Positive on 31Dec2020.; Sender's Comments: Based on the current available information, the events Drug ineffective and COVID-19 are unlikely related to BNT162B2 vaccine. The events occurred 3 days after vaccination, when vaccine was not expected to achieve the effect. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/31/2020,3.0,PHM,SYNTHROID,,Medical History/Concurrent Conditions: Hypothyroidism,,,"['COVID-19', 'Chills', 'Drug ineffective', 'Euphoric mood', 'Insomnia', 'Lymphadenopathy', 'Nightmare', 'Ocular hyperaemia', 'Pharyngeal mass', 'Polymerase chain reaction', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1023508,TX,,M,"patient is done with the first dose and tested positive after; patient is done with the first dose and tested positive after; This is a spontaneous report from a Pfizer-sponsored program, by a contactable physician. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was done with the first dose and tested positive after on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The patient is about to be done with quarantine and asking if it's okay to take the second dose. Information about batch/lot number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and SARS-CoV-2 test positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1023511,OK,,F,"sore muscles; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported that. a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) as first dose (Batch/lot number: unknown) via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that in Jan2021 patient experienced sore muscles, headache and felt like she's dying. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/01/2021,,UNK,,,,,,"['Headache', 'Myalgia']",1,PFIZER\BIONTECH, 1023513,LA,,F,"positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a Pfizer-sponsored program by a contactable consumer (patient). This female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 22Jan2021 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient resulted positive to COVID-19 after vaccination on 28Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 28Jan2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/28/2021,6.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1023514,AZ,,F,"she tested positive for covid virus.; she tested positive for covid virus.; This is a Spontaneous report from a Pfizer Sponsored Program from a contactable consumer who reported for herself. A female patient of an unspecified age received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on 12Jan2021 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 19Jan2021, patient tested positive for covid virus. She was supposed to get #2 covax on 02Feb2021 but was told she had to wait 14 days after the virus test. The outcome of the event was unknown. Information on the Lot/Batch Number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/19/2021,7.0,UNK,,,,,,"['Drug ineffective', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1023535,AZ,57.0,F,"Tested positive; Tested positive; This is a spontaneous report from a contactable consumer. This consumer reported for a 57-year-old female patient (reporter's grandmother) that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. Medical history was reported as 'no'. Concomitant medications were not reported. The patient had a vaccine appointment on the 30th but she tested positive on the 11Jan2021 and she was wondering if she went to get her vaccine or did she wait until other guys call her. Treatment received for the event. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (tested positive) with BNT162b2 can not be fully excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/11/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1023564,CO,81.0,M,"Resident found on floor beside chair, unable to rouse. Blood Sugar upon paramedics arrival to facility of 66, blood sugar reported by hospital upon emergency department arrival of 18. Emergency Department discovered Urinary Tract Infection present, resident admitted to hospital and discharged from hospital to rehabilitation skilled nursing facility.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,02/03/2021,02/05/2021,2.0,SEN,"Metformin, Norco, Lantus, Tylenol, Lantus, Wixela, Melatonin, Carvedilol, Rosuvastatin, Duloxetine, Tamsulosin, Buproban, Allopurinol",Urinary Tract Infection 1/11/21,"OTHER SPECIFIED DIABETES MELLITUS 7/26/2020 DIFFICULTY IN WALKING, NOT ELSEWHERE CLASSIFIED MUSCLE WEAKNESS (GENERALIZED) COGNITIVE COMMUNICATION DEFICIT VITAMIN D DEFICIENCY, UNSPECIFIED ANXIETY DISORDER, UNSPECIFIED UNSPECIFIED DEMENTIA WITH BEHAVIORAL DISTURBANCE OBSTRUCTIVE SLEEP APNEA (ADULT) (PEDIATRIC) ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS DISORDER OF THYROID, UNSPECIFIED CHRONIC PAIN, NOT ELSEWHERE CLASSIFIED CHRONIC GOUT, UNSPECIFIED ESSENTIAL (PRIMARY) HYPERTENSION TYPE 2 DIABETES MELLITUS GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS OTHER ARTHRITIS HYPERLIPIDEMIA, UNSPECIFIED DISORDER OF PROSTATE, UNSPECIFIED MAJOR DEPRESSIVE DISORDER, RECURRENT, UNSPECIFIED ALLERGIC RHINITIS, UNSPECIFIED CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED",,Orphenadrine,"['Blood glucose decreased', 'Depressed level of consciousness']",1,PFIZER\BIONTECH,IM 1023583,IL,41.0,F,"Severe left ear pain and fullness with associated right side complete facial paralysis. I was diagnosed with Bell's Palsy 1/9/20, 5 days after getting my first moderna vaccine.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/04/2021,01/09/2021,5.0,PVT,amlodipine 5mg once daily,none,"hypertension, asthma, palpitations",,none,"['Angiogram', 'Blood test', 'Computerised tomogram head', 'Ear discomfort', 'Ear pain', 'Facial paralysis', 'Hemiplegia']",1,MODERNA,IM 1023611,MS,80.0,F,Hospitalized with Covid-19,Not Reported,,Yes,Yes,16.0,Not Reported,N,01/13/2021,01/26/2021,13.0,PVT,Tylenol #3 Allopurinol 300mg Omeprazole 20mg Cholorthalidone 25mg Metoprolol ER 100mg Trunature Digestive Probiotic,C Diff colitis,HTN ASCVD Abdomenal Aortic Aneurysm COPD DJD GERD C Diff colitis,,Cipro Penicillin,"['COVID-19', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1023612,FL,54.0,F,"Patient received dose 1 of COVID-19 vaccine on 1/15/2021 and dose 2 on 2/5/2021. Approximately 1 week after the 1st dose, patient said she developed a rash. On presentation on 2/10/21, the rash appeared to be petechial in nature. Prior to coming to the hospital, the patient had blood work done at her ALF and was told she had zero platelets and she was sent to the hospital. Admission labs at the hospital on 2/10 also showed zero platelets and immune thrombocytopenia is suspected.",Not Reported,,Yes,Yes,,Not Reported,U,01/15/2021,01/21/2021,6.0,SEN,Anoro Ellipta inhaler - 1 inhalation once a day Baclofen 10mg PO QHS folic acid 0.5mg PO daily Lexapro 10mg PO daily Lopressor 25mg PO BID oxybutynin 24hr ER tab 5mg PO daily Pravastatin 40mg tab take 1.5 tabs PO daily Tizanidine 4mg PO Q8H,"Patient states she had some shortness of breath before initial dose, was worked up by her primary care with no cause identified and no treatment necessary","Chronic kidney disease, hypertension, ectodermal dysplasia, uterus didelphys, obstructive sleep apnea, hyperlipidemia, depression, anxiety",,Prednisone - causes fast heart rate (not true allergy),"['Blood fibrinogen increased', 'Blood lactate dehydrogenase increased', 'Coombs direct test negative', 'Fibrin D dimer increased', 'Haemoglobin decreased', 'Immune thrombocytopenia', 'Petechiae', 'Platelet count decreased', 'Red blood cell sedimentation rate increased']",2,PFIZER\BIONTECH,IM 1023650,CA,73.0,M,"Pt began having a headache and sore arm the day of the shot. The next day the patient complained of worsening headache, dizziness and ""feeling like I cannot get my words out and I have to keep re-reading everything out loud to understand"". 36 hours later, Patient checked into Emergency room with obvious expressive aphasia and complained of dizziness. Pt received CT scan and results as follows: Acute left parietal intraparenchymal hemorrhage measuring 2.8 cm, with a hematocrit effect, which can be seen in patients on anticoagulation therapy or with underlying coagulopathy. Rounded appearance raises the possibility for underlying mass. Local mass effect. No midline shift or brain herniation. Moderate associated local extra-axial hemorrhagic extension, predominantly within subarachnoid space.",Not Reported,,Yes,Yes,3.0,Not Reported,N,02/03/2021,02/04/2021,1.0,PVT,Vitamin B-12 1000mcg once daily Flonase 50cg INH daily,none,none,,Penicillin,"['Aphasia', 'Back pain', 'Cerebral haemorrhage', 'Chest X-ray', 'Computerised tomogram head abnormal', 'Dizziness', 'Feeling abnormal', 'Headache', 'Laboratory test', 'Magnetic resonance imaging brain abnormal', 'Pain in extremity', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,IM 1023668,KS,25.0,F,Headache started on 1/26. Woke up from a nap on 1/30 at 1:30pm and was having difficulty with speech. I could not say the words I wanted to and words that I could get out sounded very slurry. I went to the Emergency Room where I was stroke-activated. I was admitted to the hospital 1/30 and discharged 1/31.,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/08/2021,01/30/2021,22.0,WRK,"Metoprolol tartrate, escitalapram, dicyclomine, multivitamin, oral contraceptive pill",Headache started 1/26,None,,None,"['Aphasia', 'Blood thyroid stimulating hormone', 'Cerebrovascular accident', 'Chest X-ray normal', 'Computerised tomogram normal', 'Dysarthria', 'Full blood count normal', 'Headache', 'Lipids normal', 'Magnetic resonance imaging normal', 'Metabolic function test', 'Metabolic function test normal', 'SARS-CoV-2 test', 'Speech disorder', 'Toxicologic test normal']",1,MODERNA,SYR 1023673,KY,78.0,M,"Patient was vaccinated on 1/14/2021. On 1/22/2021, patient tested positive for COVID-19 and admitted to the hospital for acute hypoxemic respiratory failure, COVID-19 pneumonia, and severe ARDS. Patient was intubated on 1/23/2021 and later died on 2/10/2021 after being extubated and placed on comfort measures.",Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/22/2021,8.0,PUB,unknown,unknown,"HTN, HLD, diabetes type II, iron deficiency anemia, GERD, BPH, COPD",,unknown,"['Acute respiratory distress syndrome', 'COVID-19 pneumonia', 'Death', 'Endotracheal intubation', 'Respiratory failure', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1023685,,39.0,M,"39 year old male no known past medical history received his second dose of the moderna vaccine on 2/5. That evening he developed headache, malaise, fatigue, fevers. The symptoms persisted on 2/6 and 2/7 with some improvement in his headache on 2/7. On the evening of 2/7 he developed high fevers to 103, rigors, ""vivid dreams"" woke up with night sweats. On 2/8 developed pleuritic chest pain and shortness of breath and went to the hospital.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/05/2021,02/05/2021,0.0,MIL,None,None,None,,No known allergies,"['Abnormal dreams', 'Angiogram', 'Angiogram abnormal', 'C-reactive protein increased', 'Catheterisation cardiac normal', 'Chest pain', 'Chills', 'Coxsackie virus test', 'Dyspnoea', 'Echocardiogram normal', 'Electrocardiogram normal', 'Fatigue', 'Full blood count normal', 'Headache', 'Low density lipoprotein increased', 'Lymphadenopathy', 'Magnetic resonance imaging heart', 'Malaise', 'Metabolic function test normal', 'Mycoplasma test', 'Myocarditis', 'Night sweats', 'Pericardial effusion', 'Pleuritic pain', 'Pyrexia', 'Respiratory viral panel', 'SARS-CoV-2 test negative', 'Troponin increased']",UNK,MODERNA,IM 1023689,,44.0,M,"Received vaccination on 2/2/21 @ 0900. Immediately afterwards he said he was in excruciating pain. He reported he went to his primary care provider later that afternoon. He was examined clinically and was told that the shot was administered too high up in his arm in the Gleno Humeral Joint. He was advised to take over the counter pain medication and to call if he needs something stronger. He was given a follow up appointment on 2/5/2021 with the provider. He was told to monitor for infection in the next 48 hours and they are hoping it did not go into the joint capsule. Continued to have severe pain. Went to orthopedic specialist the next day. Admitted to hospital for pain control and steroids. MRI of shoulder inconclusive, but think severe bursitis and being treated as such. Discharged from hospital and resting at home. Arm range of motion at 80%-hoping to return to work in 2 weeks (firefighter/EMT).",Not Reported,,Not Reported,Yes,,Not Reported,N,02/02/2021,02/02/2021,0.0,PUB,,,,,,"['Bursitis', 'Immediate post-injection reaction', 'Impaired work ability', 'Injected limb mobility decreased', 'Joint range of motion decreased', 'Magnetic resonance imaging', 'Orthopaedic examination abnormal', 'Pain', 'Product administered at inappropriate site']",2,MODERNA,IM 1023722,NJ,56.0,F,"Pt without h/o hematologic disease. Admitted to hospital <2 weeks after vaccination with acute severe thrombocytopenia (platelets 17) without otherwise normal CBC/diff. No symptoms other then bruising and minor bleeding (epistaxis). Pt treated as ITP with oral dexamethasone bolus (40mg PO qd x 4). Immediate improvement of thrombocytopenia. February 11, 2021 06:10 94 L 10 3/cumm February 10, 2021 06:50 36 L 10 3/cumm February 9, 2021 13:55 17 CL 10 3/cumm Will be discharged on to complete steroids on 2/12 and then labs/CBC will be monitored every few days as outpt. Pt to continue to hold BASA until at least confirm stability of platelets off Rx.",Not Reported,,Yes,Yes,,Not Reported,Y,01/26/2021,02/08/2021,13.0,PVT,"BASA, atorvastin, Ca+, MVI",None,HLD,,None,"['Contusion', 'Differential white blood cell count normal', 'Epistaxis', 'Full blood count normal', 'Haemorrhage', 'Metabolic function test', 'Platelet count decreased', 'Thrombocytopenia', 'Ultrasound abdomen normal']",1,MODERNA,SC 1023763,IN,85.0,F,"Patient had no immediate reaction, vital signs remained stable, resident condition did not change, 4 days later became lethargic, O2 sats dropped and sent to the ER.",Not Reported,,Not Reported,Yes,,Not Reported,,02/05/2021,02/09/2021,4.0,SEN,magnesium,"Pneumonia, UTI","CKD, CHF, DM, COPD, Dyshpagia, HLD, CVA, HTN,",,nka,"['Lethargy', 'Oxygen saturation decreased']",2,MODERNA,IM 1023768,WA,86.0,M,"Patient awoke at 1:00 AM on 2/10/2021, five days after his Moderna COVID-19 booster, with chest pain radiating to the back and worse with deep inspiration. Patient arrived in our office on 2/10/2021 at 9:30 AM for an evaluation. Patient was noted to have new EKG changes with new concave-up ST elevation across the precordium. Bedside echocardiogram showed no pericardial effusion and no pericardial friction rub was appreciated. Due to ongoing chest pain, patient was transported to Emergency Department by medics for further workup and evaluation for possible pericarditis. Formal echocardiogram in ED was normal. Acute myocardial infarction ruled out. ST changes improved. Patient now being discharged in stable condition 2/11/2021.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/05/2021,02/10/2021,5.0,PVT,"omeprazole 20 mg delayed release, fluoxetine 20 mg capsules, aspirin 81 mg",None,Cognitive impairment History of prostate cancer status post XRT in 2003 with biochemical recurrence in November 2011. History of bladder cancer.,,"donepezil (GI upset), antibiotic (PCN maybe, but Zithromax tolerated without issues).","['Back pain', 'C-reactive protein increased', 'Chest X-ray normal', 'Chest pain', 'Echocardiogram normal', 'Electrocardiogram ST segment elevation', 'Pain', 'Painful respiration', 'Procalcitonin normal', 'White blood cell count increased']",2,MODERNA,IM 1023791,CA,71.0,M,"DIED WITHIN 5 DAYS OF RECEIEVING THE 2ND DOSE, EXPERIENCED GENERALIZED WEAKNESS.",Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/01/2021,5.0,SEN,"Escitalopram Oxalate,amlodipine,aspirin,cyanocobalamin,docusate sodium,ergocalciferol,evothyroxine,Melatin,multivitamin,pravastatin,loratadine,senna,Protonix,carvedilol,Lokelma,lidocaine adhesive patch,buprenorphine ,hydralazine,Miralax,hy",": G93.40 Encephalopathy, unspecified(Primary, Admission), R56.9 Unspecified convulsions, S06.5X9D Traumatic subdural hemorrhage with loss of consciousness of unspecified duration, subsequent encounter, M62.81 Muscle weakness (generalized), R26.89 Other abnormalities of gait and mobility, Z48.811 Encounter for surgical aftercare following surgery on the nervous system, W19.XXXD Unspecified fall, subsequent encounter, R47.01 Aphasia, N17.9 Acute kidney failure, unspecified, N18.30 Chronic kidney disease, stage 3 unspecified, D64.9 Anemia, unspecified, N28.1 Cyst of kidney, acquired, E11.9 Type 2 diabetes mellitus without complications, E03.9 Hypothyroidism, unspecified, I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris, I50.22 Chronic systolic (congestive) heart failure, I21.4 Non-ST elevation (NSTEMI) myocardial infarction, N28.9 Disorder of kidney and ureter, unspecified, F33.9 Major depressive disorder,",": G93.40 Encephalopathy, unspecified(Primary, Admission), R56.9 Unspecified convulsions, S06.5X9D Traumatic subdural hemorrhage with loss of consciousness of unspecified duration, subsequent encounter, M62.81 Muscle weakness (generalized), R26.89 Other abnormalities of gait and mobility, Z48.811 Encounter for surgical aftercare following surgery on the nervous system, W19.XXXD Unspecified fall, subsequent encounter, R47.01 Aphasia, N17.9 Acute kidney failure, unspecified, N18.30 Chronic kidney disease, stage 3 unspecified, D64.9 Anemia, unspecified, N28.1 Cyst of kidney, acquired, E11.9 Type 2 diabetes mellitus without complications, E03.9 Hypothyroidism, unspecified, I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris, I50.22 Chronic systolic (congestive) heart failure, I21.4 Non-ST elevation (NSTEMI) myocardial infarction, N28.9 Disorder of kidney and ureter, unspecified, F33.9 Major depressive disorder,",,"methadone, morphine, nortriptyline","['Asthenia', 'Death']",7+,MODERNA,IM 1023803,IL,92.0,F,Was contacted by the person's daughter on 2/5/21. Patient started vomiting 2 days after vaccination. She aspirated and passed away 1/16/21. Patient had history of stroke and swallowing problems.,Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,SEN,,,,,,"['Aspiration', 'Death', 'Vomiting']",1,PFIZER\BIONTECH,IM 1023840,IL,62.0,M,Pt was administered Moderna Covid-19 Vaccine on 2/4/2021. Pt exhbited no symptoms of an adverse reaction of any sort. Pt was ambulating alert and attentive. Pt was observed for the alloted 15 mins by pharmacist and case worker who had escorted pt to vaccination clinic. It was reported that Either on sunday 2/7/2021 or monday 2/8/2021 pt had passed away. Circumstances revolving patient death is still unknown.,Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/08/2021,4.0,OTH,"Ziprasidone, divalproex, haloperidol, allopurinol, Lisinopril, atorvastatin, aspirin, carvedilol","Hypertension, Morbid Obesity, DMII, Neuropathy, Cardiomyopathy, Hyperurecemia, Glaucoma, Polyp, Foliculitis, Bi-Polar disorder.",Same as above.,,"NKDA, NKA",['Death'],1,MODERNA,IM 1023863,VA,77.0,F,"Patient has called to inform us (4 months after immunization) that she is having pain and reduced mobility in her shoulder, beginning shortly after being immunized.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,09/25/2020,09/26/2020,1.0,PHM,,,"Inflammation, Pain, Insomnia.",,,"['Mobility decreased', 'Pain']",,SANOFI PASTEUR,IM 1023866,NC,28.0,F,Miscarriage at 6 weeks 1 day. Vaginal bleeding and decline in HCG hormone. Pregnancy not viable.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,02/11/2021,27.0,WRK,Prenatal vitamin,None,None,,None,"['Abortion spontaneous', 'Exposure during pregnancy', 'Full blood count', 'Gynaecological examination abnormal', 'Human chorionic gonadotropin decreased', 'Vaginal haemorrhage']",1,PFIZER\BIONTECH,IM 1023887,MA,54.0,M,"24 hours post vaccine develoved T 100.1, headache, light sensitivity, reports headache worsened, blurred vision - went to Emergency Services at Hospital, admitted. Reports diagnosis of CVA. Reports headache has improved, continues with blurred vision",Not Reported,,Not Reported,Yes,,Not Reported,U,02/09/2021,02/10/2021,1.0,WRK,Unknown,,s/p non Q wave MI (which presented as heart burn)5/04 with stent placement,,,"['Body temperature increased', 'Cerebrovascular accident', 'Headache', 'Photophobia', 'Vision blurred']",UNK,PFIZER\BIONTECH,IM 1023903,AZ,43.0,F,"Patient was given vaccine at 1051AM and was monitored in parking lot for 15 minutes. Patient was near the 15 minute when a lot attendant came to me saying the patient had an itchy throat. I went to patients car to assess the patient. Patient c/o itchy throat. At approximately 1112AM patient stated that her throat felt like it was closing O.3mg EPI was given in left thigh and 911 was called simultaneously by another person. Approximately 8 minutes later patient stated her throat was closing again. A 2nd dose of 0.3mg of EPI was administered in left thigh while awaiting EMS. arrived, EMS started IV patient transported to ER for observation",Not Reported,,Yes,Yes,,Not Reported,Y,02/04/2021,02/04/2021,0.0,OTH,,NONE,Asthma Depression,,NKA,"['Throat irritation', 'Throat tightness']",1,MODERNA,IM 1023912,LA,64.0,M,"Patient is currently hospitalized in Hospital with Covid. His Wife reported admission with O2 Sat at 48. He has Pneumonia, Ketones of 4, borderline ketoacidosis, and Fluid on his lungs,.",Not Reported,,Yes,Yes,6.0,Not Reported,N,02/03/2021,02/05/2021,2.0,PVT,Unknown,none,"Heart condition Diabetes, Vaccine recommended by Heart specialist",,none,"['Blood ketone body', 'COVID-19', 'COVID-19 pneumonia', 'Ketoacidosis', 'Oxygen saturation decreased', 'Pulmonary oedema']",1,MODERNA,IM 1023913,VA,83.0,F,"1/11 I had an EKG that was normal. after receiving the vaccine, my chest started hurting, both arms started hurting really bad. 30 hours later the arms stopped hurting but the chest was still hurting. back started hurting but went away but the chest still hurt. I went to Dr. 3 days after i started hurting and he did an EKG 1/25 and that evening the DR called and said ""GO TO THE HOSPITAL YOU ARE HAVING A HEART ATTACK. CALL AN AMBULANCE."" I took an ambulance to the hospital and had surgery and had 3 stints put in.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/20/2021,01/21/2021,1.0,PVT,Vit D Fish oil 10 mg senthostatin,no,no,shingrix- sore arm,no,"['Atrioventricular block', 'Back pain', 'Cardiac operation', 'Chest pain', 'Coronary arterial stent insertion', 'Electrocardiogram abnormal', 'Myocardial infarction', 'Pain in extremity']",1,MODERNA,SYR 1023917,CA,67.0,M,"He has lost a lot of feeling and motor skills on his left side. he is dropping lots of things and he cannot drink very well, things are falling out his mouth.",Not Reported,,Not Reported,Yes,,Yes,N,02/01/2021,02/10/2021,9.0,OTH,"wellbutrin 150 mg, nexium ,allopurinol",pnemonia a month and one week before,none,,none,"['Fine motor skill dysfunction', 'Hemiparesis', 'Hemiplegia', 'Sensory loss']",1,MODERNA,IM 1023948,NC,63.0,F,"02/08/21--2 days after vaccine--Resident stated that she ""didn't feel good"" (She is developmentally delayed and less able to communicate how she feels than those in the community) and stopped eating most foods; also had fatigue. Vitals, coloring, & behavior were normal. 02/09/21--Belly was firm and mildly distended (although she stated it didn't hurt); she coded this evening and CPR was performed before EMT could transport her to the hospital. 02/10/21--Resident passed.",Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/08/2021,2.0,OTH,Vitamin C 500 mg daily Bisacodyl 10 mg daily Calcium Carbonate/Vitamin D 500/200 twice daily Clomipramine 100 mg twice daily Divalproex DR 1000 mg twice daily Levothyroxine 50 mcg daily Lisinopril 10 mg twice daily Metoprolol Succinate ER 5,No,Intellectual Disability Disorder Behavior Disorder (OCD/IED) Hypertension Hyperlipidemia Hypothyroidism Constipation Osteopenia,,Carbamazepine Loxapine Sulfa Antibiotics Tetracyclines Penicillins,"['Abdominal distension', 'Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Bacterial test positive', 'Blood sodium decreased', 'Blood urine present', 'Cardio-respiratory arrest', 'Death', 'Decreased appetite', 'Fatigue', 'Feeling abnormal', 'Lymphocyte count increased', 'Neutrophil count increased', 'Prothrombin time prolonged', 'Resuscitation', 'Troponin increased', 'Urine abnormality', 'Urine analysis abnormal', 'White blood cell count increased']",2,MODERNA,IM 1023979,TX,76.0,M,Moderna administered 02/01/21. Patient expired 02/10/2020 unexpectedly,Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/10/2021,9.0,OTH,"Medications Azopt 1% ophthalmic suspension, 1 drops, Eye-Both, BID bacitracin/neomycin/polymyxin B topical, 1 appl, Topical, BID, PRN Briviact, 50 mg, 5 mL, Oral, BID calcium carbonate 600 mg (elemental Ca 240 mg) oral tablet, 600 mg,",Dehydration Leukocytosis Dysphagia UTI - Sepsis-resolved Hypernatremia Paroxysmal atrial fibrillation with sick sinus syndrome; S/P pacemaker placement 12/29/20 Acute kidney injury secondary to hypovolemia Macrocytic anemia,"Active Problems Coloboma of iris Atrial fibrillation Mild to moderate hearing loss Dysphagia Peripheral vascular disease Dementia with behavioral disturbance Seborrhea Lagophthalmos Benign prostatic hyperplasia Chronic constipation Gastroesophageal reflux disease Osteopenia Epilepsy Profound ID (IQ <20) ASCVD risk Age-related nuclear cataract, left eye Cardiomegaly Chronic Ileus and megacolon Chronic conjunctivitis Chronic diastolic (congestive) heart failure Chronic obstructive pulmonary disease, unspecified Colostomy and ileostomy status Cyst of right kidney, acquired Dementia with behavioral disturbance Dry eye syndrome of bilateral lacrimal glands Hypocalcemia Hypothyroidism Hypovitaminosis D Iron deficiency anemia Mild hearing loss Mood disorder Nonexudative age-related macular degeneration, left eye, intermediate dry stage Obstructive sleep apnea (adult) (pediatric) Ogilvie's syndrome Other seasonal allergic rhinitis Presence of cardiac pacemaker 12/29/2020 Primary open-angle glaucoma, bilateral, moderate stage Proteinuria Recent weight gain Recurrent UTI - urinary tract infection Recurrent hypernatremia and dehydration Sick sinus syndrome Sick sinus syndrome s/p pacemaker 12/29/20",,NKDA,['Death'],1,MODERNA,IM 1023984,GA,62.0,M,"Shortly after first vaccine, patient was hospitalized with COVID disease. This was not an AE to vaccine. However, vaccine providers are required to report if a patient receiving vaccination has to be hospitalized from COVID.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/12/2021,01/15/2021,3.0,PHM,,,,,,['COVID-19'],1,MODERNA,IM 1024000,WI,73.0,M,Pt received his first dose of the Pfizer COVID-19 vaccine on 2/2/20201. Pt presented to a local ED on 2/10/2021 with symptoms of dyspnea and respiratory distress and was transferred/admitted to our hospital. He tested positive per PCR testing for SARS-CoV-2 on 2/10/2021. He is still currently admitted to our hospital receiving care. It was noted in his H&P that he had a COVID exposure approximately 2 weeks prior to presenting to the ED (unknown if he was alerted to this before getting his vaccine). He is currently recieveing remdesivir and dexamethazone to treat his COVID.,Not Reported,,Not Reported,Yes,,Not Reported,N,02/02/2021,02/11/2021,9.0,OTH,"aspirin, fluticasone-salmeterol, hydrochlorothiazide, lisinopril, melatonin, metoprolol succinate, multivitamin, omeprazole, probiotic unspecified, rosuvastatin, sertraline, trazodone, umeclidinium bromide",,"Abnormal PET scan of lung, cataract, colon cancer, COPD, depression, GERD, hypertension, iron deficiency anemia, malnutrition, NSCLC of right lung,",,Bee Venom,"['COVID-19', 'Dyspnoea', 'Respiratory distress', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1024003,OR,6.0,M,"10 minutes after vaccine were administered, patient had a syncopal episode.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,PVT,none,none,history of anemia d/t secondary iron deficiency in 2015,,no known allergies,['Syncope'],3,MERCK & CO. INC.,IM 1024013,NY,81.0,M,"Had a stroke, blood clot removed from brain",Not Reported,,Yes,Yes,7.0,Yes,N,01/18/2021,02/04/2021,17.0,PHM,"Metoprolol, Eliquis, Allopurinal, Atorvastatin, Procardia, Prograf, Cellcept, Furosemude, Tujeo, Humalog",None,"Kidney transplant, Diabetes, Heart, Aortic valve replacement, High blood pressure",,None,"['Brain operation', 'Cerebrovascular accident', 'Thrombectomy']",1,PFIZER\BIONTECH,SYR 1024048,SC,78.0,M,"The next two days following the vaccination, the patient was lethargic and not getting out of bed. His caregiver had to make him eat and bathe. On the third day his care giver had woken him up and found that he had wet himself (this has never happened before). He had altered mental status and was not able to recognize any of his family members. He was taken to the emergency room on 2/6/2021 where he had a seizure and found to have a subarachnoid hemorrhage. He is still hospitalized.",Not Reported,,Yes,Yes,6.0,Not Reported,N,02/02/2021,02/03/2021,1.0,PVT,pantaprozole,none,HTN-controlled without medications currently Hyperlipidemia- controlled without medications currently GERD- vitamin D deficiency- controlled without medications currently,,none,"['Angiogram cerebral abnormal', 'Arteriogram carotid abnormal', 'Lethargy', 'Memory impairment', 'Mental status changes', 'Mobility decreased', 'Seizure', 'Subarachnoid haemorrhage', 'Urinary incontinence']",UNK,PFIZER\BIONTECH,IM 1024051,,83.0,F,Increased confusion about six hours after vaccine lasting about 12-18 hours. Resolved spontaneously,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/09/2021,02/10/2021,1.0,UNK,,,,,,['Confusional state'],UNK,MODERNA,SC 1024067,VA,54.0,M,"1/15: Pfizer vaccine dose 1 administered 1/16: Fever, chills 1/22: Sore throat, coughing w/white phlegm, taking Tylenol and Mucinex. Fever and chills from 1/16 subsided. Had telehealth consultation with PA. Per her notes, patient said he gets these symptoms annually, requested for an antibiotic. PA referred him for a COVID test. Ordered hydrocodone/chlorphen ER suspension for his cough and an antibiotic. Antibiotic was recommended if symptoms do not subside. 1/23: COVID test administered 1/25: Reported positive for COVID 1/26: Telehealth session w/PA: she informed patient of his positive test, advised to quarantine and seek medical help at hospital if symptoms worsen. Patient reported that his sore throat mostly subsided but is still coughing at night. Said that the pharmacy didn't receive the prescription order for the antibiotic, so this was re-ordered. 1/31: Partner found him dead at 8:18AM on his bed. Death certificate issued by state says cause of death: COVID. Autopsy was not performed. Buried on 2/9/21.",Yes,01/31/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/31/2021,16.0,PVT,Hydrocodone/Chlorphen ER Suspension Tylenol Mucinex,,None,,No,"['COVID-19', 'Chills', 'Death', 'Oropharyngeal pain', 'Productive cough', 'Pyrexia', 'SARS-CoV-2 test positive', 'Sputum discoloured']",1,PFIZER\BIONTECH,IM 1024089,MN,75.0,F,"Patient became weak, had the chills, and spiked a fever.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/08/2021,02/09/2021,1.0,PVT,,,,,,"['Asthenia', 'Chills', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1024099,CA,98.0,F,I am the discharging physician and did not admit her but based off the information at admit: the patient received her Pfizer vaccine and developed nausea during her observation time but it was not significant enough to cause concern for the family. They took her home in good spirits and she appeared to be doing well until the evening when she became unresponsive. She developed high fevers and came to the ER with low normal O2 saturations and evidence of sepsis. Blood work showed a markedly elevated white count and an elevated lactic acid of 8 along with an elevated renal function and cardiac enzymes without EKG changes (multiorgan failure). Her COVID test was negative. Blood and urine cultures were negative. A CT scan of the abdomen demonstrated no acute findings but likely chronic fecal impaction. CT Head was negative for bleed or stroke. At this time is is unclear as to what was the cause of her symptoms but we believe it was presumed bacterial sepsis but this diagnosis is in question as all her cultures were unremarkable. The family opted on comfort measures rather than aggressive intervention and she was sent home with hospice. Since it occurred so closely after receiving the vaccine I think it was worthwhile to bring it to your attention.,Not Reported,,Yes,Yes,2.0,Not Reported,N,02/08/2021,02/08/2021,0.0,OTH,Clonidine 0.2mg patch weekly Plavix 75mg daily Paxil 20mg daily Lipitor 10mg daily Protonix 40mg daily,Unknown,Dementia Functional quadriplegia (ADL dependent) HTN H/O CVA with right sided weakness TIAs HLD H/O breast cancer,,NKDA,"['Bacterial sepsis', 'Blood culture negative', 'Blood lactic acid', 'Blood lactic acid increased', 'Blood test normal', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram abdomen normal', 'Computerised tomogram head normal', 'Culture urine negative', 'Electrocardiogram normal', 'Faecaloma', 'Multiple organ dysfunction syndrome', 'Myocardial necrosis marker increased', 'Nausea', 'Oxygen saturation decreased', 'Pyrexia', 'Renal impairment', 'SARS-CoV-2 test negative', 'Sepsis', 'Unresponsive to stimuli', 'White blood cell count increased']",UNK,PFIZER\BIONTECH,IM 1024101,MA,61.0,F,Patient received first dose of Moderna COVID vaccine and then developed a reaction called inflammatory ophthalmitis. Was admitted in hospital and treated with high dose prednisone. Is improving and being followed by eye clinic.,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/06/2021,01/19/2021,13.0,PVT,,,,,None,"['Inflammation', 'Panophthalmitis']",1,MODERNA,IM 1024111,MA,55.0,F,"Sore arm first injection as expected. 2nd more sore. Some fatigue. Felt totally fine prior to until my husband turned onto our home street and I started to verbalize that this is not our neighborhood nor our house. I then started to have a seizure which I was told lasted 5 minutes and was turning blue. I was buckled at the time. I have compression fractures of T12 to L2 He called an ambulance and I had a second one. I had ct , mri, mra, eeg, ekg, labs. Treated with muscle relaxants, toradol. Put on keppra. Cannot drive for 6 months. All new onset. Having a lot of back spasms especially in the night My mouth and tongue are sore from biting on it During seizure Foggy thinking and decreased memory",Not Reported,,Yes,Yes,2.0,Not Reported,N,02/03/2021,02/08/2021,5.0,PVT,Vit d Mvi Mag prn for sleep,None,None,,Oxycodone Percocet,"['Amnesia', 'Angiogram', 'Computerised tomogram', 'Electrocardiogram', 'Electroencephalogram', 'Fatigue', 'Feeling abnormal', 'Glossodynia', 'Impaired driving ability', 'Laboratory test', 'Magnetic resonance imaging', 'Memory impairment', 'Mouth injury', 'Muscle spasms', 'Oral pain', 'Pain in extremity', 'Posture abnormal', 'Seizure', 'Skin discolouration', 'Spinal compression fracture', 'Tongue biting']",2,MODERNA,IM 1024121,TX,88.0,F,"COULD NOT STAND OR WALK, KEPT HER EYES CLOSED, LEANING TO ONE SIDE, SHAKING, COULD NOT FEED HERSELF, COULD NOT UNDERSTAND COMMANDS OR CUES, COULD STAND TO CHANGE BRIEF OR PULL HER PANTS DOWN, COULD NOT DRINK...LIKE SHE FORGOT HOW, WOULD NOT STAND TALL WITH SOMEONE HELPING, DID NOT KNOW HOW TO PICKUP FORK. VERY AMBULATORY, FED YOURSELF, DRESSED HERSELF UNDERSTOOD COMMANDS BEFORE THIS HAPPENED",Not Reported,,Not Reported,Yes,5.0,Yes,N,01/20/2021,01/22/2021,2.0,OTH,"Levothryroxine 75mcg OD, lexapro 5 mg QD, KCL 10mg QD, metformin ER 500 mg BID , vitamin C 500 mg BID, zinc 220 mg BID, metoprolol 50 mg BID, Namenda 10 mg BID, ASA 81 mg QD, simvastatin 40 mg QD , tylenol 500 mg P","UTI, ADVANCED MEMORY LOSS, TYPE 2 DIABETES, ANXIETY",LONG STANDING,,"SULFA ANTIBIOTICS, NSAIDS","['Dysstasia', 'Feeding disorder', 'Fluid intake reduced', 'Gait disturbance', 'Hemiparesis', 'Laboratory test', 'Laboratory test normal', 'Mental impairment', 'Posture abnormal', 'Pyrexia', 'Tremor', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 1024131,WI,58.0,F,Very severe headache very severe body aches and appendecitis I am not sure if the appendicitis is related to the shot but I thought I should report that,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/26/2021,01/26/2021,0.0,WRK,"Lexapro, Protonix, vitamin D, prevastatin, claritin,",No,High cholesterol gastric reflux seaonal allergies,,Codeine,"['Appendicectomy', 'Appendicitis', 'Headache', 'Pain']",2,MODERNA,IM 1024135,MN,74.0,M,"Bloody nose 4:00 AM so I could drive and get my dialysis done. I was on for about and hour they decided to take me off and then I went around the building to the health partners urgent care and they ballooned my nose to stop the bleeding. They took an INR test and it was 11.5, so my son took me took the hospital. They gave me vitamin K as soon as I got in the ER and kept me in the hospital for three days.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/29/2021,02/01/2021,3.0,OTH,coumadin 7.5 mg two days a week 5mg the other five days torvastatin 80 mg daily calcetrol .5 mg daily vitamin d3 125 mg sensopar 60 mg lantis insulin metropril titrate 100 mg renvella 800 mg renal vitamin 1mg,sinus infection,open heart surgery on dialysis diabetic,,latex,"['Epistaxis', 'International normalised ratio increased', 'Nasal cavity packing', 'Vitamin K', 'Vitamin K decreased']",1,MODERNA,SYR 1024145,TN,83.0,F,"--Patient (and patient's husband) report that patient was given 2 doses of Pfizer Covid 19 vaccine 6 days apart at the Health Department. --First dose: 2/3/21. Second dose: 2/9/21 --Patient was admitted to hospital on the evening of 2/9/21 with weakness, shortness of breath ""feeling winded"". --Patient reports feeling bad and coughing 2-3 days before being vaccinated and does NOT believe her admission to the hospital was associated with the vaccine. --County health department has been notified.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/03/2021,02/09/2021,6.0,PUB,"Lasix, Aldactone, Hydrochlorothiazide, Synthroid, Prilosec, Tylenol",Cough and weakness 2-3 days before Vaccine.,"Chronic Systolic Heart Failure, Hypothyroidism, Coronary artery disease",,"Ampicillin, Ciprofloxacin, Latex, Neosporin, Penicillin, Sulfa drugs, Tape, Tetracyclines","['Asthenia', 'Dyspnoea', 'Inappropriate schedule of product administration']",2,PFIZER\BIONTECH,IM 1024157,TX,88.0,F,"7 days after receiving the vaccine, patient suffered excessive diarrhea and slight coughing. 9 days after vaccine, patient was tested for Covid 19, and received positive results. Patient was transported to hospital via ambulance but hospital returned her to the nursing home since chest was clear, no respiratory issues, and no fever. 10 days after receiving the vaccine, patient was turned over to hospice care but still in the nursing home. Hospice was called in to provide better physician advice and access 24/7. 14 days after receiving vaccine, patient began experiencing excruciating body aches, coughing, low oxygen levels, and no appetite. 18 days after vaccine, patient died.",Yes,01/29/2021,Yes,Not Reported,,Yes,N,01/11/2021,01/20/2021,9.0,SEN,"Simvastatin, HCTZ, Sertraline, Donepezil, Fenofibrate, Vitamin D3, Vitamin B12, Zyrtec, 81mg Aspirin, Colace","Alzheimer's, Type II Diabetes",,,None,"['COVID-19', 'Cough', 'Death', 'Decreased appetite', 'Diarrhoea', 'Oxygen saturation decreased', 'Pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1024191,WI,17.0,F,"Hives and swelling. Still uncomfortable in feet and ankles. Fingers are still kind of tight. Patient noticed itching and swelling on fingers, hands, feet, toes, ankles, and knees on Sunday (2/7). Had hives, went to urgent care, thought it was allergic reaction to vaccines received. Received influenza, meningococcal, and HPV on 2/2. Given prednisone and famotidine at after hours clinic and have been taking since then, swelling has gone down, still has pain in joints. Also taking benadryl and claritin. Hives come back at night, when steroids wear off. No new foods recently, no new products, not going anywhere.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/07/2021,5.0,PVT,,,,,none,"['Allergy to vaccine', 'Arthralgia', 'Pruritus', 'Swelling', 'Urticaria']",UNK,SANOFI PASTEUR, 1024206,,51.0,M,"Nose bleed started on 2/1/21 that would not stop for 2 days. Labs checked - Platelets dropped from baseline of 210 to ""4"" - sent to hospital on 2/2/21, required ICU Admission with dx of unspecified ITP. There are no other changes of medications or regimen prior to incident. Hospital notes also suspect from COVID vaccine as otherwise unexplained. Has not fully recovered, still in ICU.",Not Reported,,Yes,Yes,,Not Reported,N,01/27/2021,02/01/2021,5.0,SEN,,,"CHF, COPD, obesity, Hep C (Cured)",,None,"['Epistaxis', 'Immune thrombocytopenia', 'Intensive care', 'Platelet count decreased']",2,PFIZER\BIONTECH, 1024223,PA,11.0,F,"Patient started with a rash on both arms , face and neck. Her face was flushed. She felt lightheaded and her arms hurt. She also became anxious. Initial VS: pulse ox:97% on RA, pulse: 102, BP: 102/64; 5 minutes later: pulse ox:96% on RA, pulse: 106 5 minutes later: Zyrtec 10 mg po given; 5 minutes later: pulse ox:99% on RA, pulse: 68; 10 minutes later: pulse ox:98% on RA, pulse: 91, BP: 104/62: lungs were CTA the entire time; no tongue swelling. Water given, a lollipop and brownie given. After 30 minutes; rash almost completely gone and pulse ox:97% on RA, pulse: 87. Patient discharged home with Mom and walked out of the office.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,PVT,MVI,none,Constipation,,Shellfish,"['Dizziness', 'Flushing', 'Pain in extremity', 'Rash']",1,SANOFI PASTEUR,IM 1024226,TX,63.0,M,"New onset dizziness with hypotension, tachycardia, and vomiting blood. Sent to ER - told he went into cardiac arrest and died.",Yes,01/14/2021,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/14/2021,8.0,SEN,,,"CAD, Atrial Fibrillation, dementia, stroke, htn, ckd, AAA",,,"['Cardiac arrest', 'Death', 'Dizziness', 'Haematemesis', 'Hypotension', 'Tachycardia']",1,PFIZER\BIONTECH, 1024245,CT,65.0,M,"Swelling, pain and weakness of left wrist and hand. I have had this to date since adverse reactions started.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/29/2021,01/30/2021,1.0,PUB,,,,,,"['Arthralgia', 'Joint swelling', 'Muscular weakness', 'Pain in extremity', 'Peripheral swelling']",1,PFIZER\BIONTECH,IM 1024274,LA,72.0,F,"caller ( admitting physician) stated pt got the vax and then she got weak on 1/26/2021. Stated he felt like she was lifting weight blocks. She went to Medical Center ER and was discharged and fell and in the parking lot. Pt came back to same ER 2 days later and was admitted w/ Guillain-Barre dx. Pt was then treated with IV Immunoglobulins. Labs; Sodium 132. BUN7 , Albumin 2.7, Glucose 112, WBC 3.5 HGB 10.4",Not Reported,,Not Reported,Yes,11.0,Not Reported,N,01/21/2021,01/26/2021,5.0,PVT,"albuterol, q6, Norvasc 10, Vitamin C, aspirin 81, liptor 20mg once daily, cosopt 1 drop both eyes, Flonase, gabapentin 300 mg, latanoprost 1 drop hs both eyes, keppra 500mg, x 2 daily, ativan1mg prn, multivitamin, oxycodone 1q4 prn, Crestor",robotic procedure for resection of carcinoid tumor on lung on 1/5/2021,"glaucoma , hypertension, hyperlipidemia, gastric reflux, obesity BMI 30, cervical spondylosis, bilateral total knee replacement, lumbar stenosis, gastro intestinal stromal tumor",,iodine,"['Asthenia', 'Blood albumin decreased', 'Blood glucose increased', 'Blood sodium decreased', 'Blood urea decreased', 'CSF protein increased', 'Fall', 'Guillain-Barre syndrome', 'Haemoglobin decreased', 'Immunoglobulin therapy', 'Limb discomfort', 'Magnetic resonance imaging spinal abnormal', 'Spinal osteoarthritis', 'White blood cell count decreased']",1,PFIZER\BIONTECH, 1024325,AR,90.0,F,"Patient passed away on February 5, 2021. There was no reaction after the shot was given, the patient's son said the death was not related to the vaccine. The patient had a bad case of shingles about a month prior to receiving the vaccine which the son said had been hard on the patient, the patient was also 90 years old. Per the son, the patient's doctor had wanted the patient to get the vaccine. Due to the close proximity of the date the vaccine was given and the date Patient passed away we wanted to complete the VAERS form.",Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/05/2021,2.0,PHM,,SHINGLES ABOUT A MONTH AGO,"AFIB, HIGH BLOOD PRESSURE, HIGH CHOLESTEROL",,LATEX,['Death'],1,MODERNA,IM 1024343,HI,75.0,F,PATIENT ARRIVED TO ED ON 2/9 IN FULL CARDIAC ARREST,Yes,02/09/2021,Not Reported,Yes,,Not Reported,N,02/05/2021,02/09/2021,4.0,PVT,HYDROXYCHLOROQUINE MONTELUKAST METOPROLOL XL PANTOPRAZOLE,,LUPUS,,ERYTHROMYCIN,['Cardiac arrest'],1,PFIZER\BIONTECH,IM 1024368,OH,39.0,F,"Patient received her 1st dose of Pfizer vaccine around 1810 on 2/9. Approximately 10-15 mins later her arm was shaking uncontrollably, she felt that her throat was closing and had chest pressure. Medics noted hives and a rash on her chest and administered Epi and Benadryl. She began exhibiting stroke-like symptoms of expressive aphasia and dysarthria in the medic?s truck around 1850. She was crying and unable to speak. She had right sided facial droop, right sided grip weakness, and right sided arm drift. Patient was transferred to MC. Patient Update: Patient received tPA on 2/9 at 1949. CT revealed no hemorrhage or large territory stroke and no large vessel occlusion. NIHSS on admission to MC was a 3. Patient was also assessed by speech pathology. Patient appears to have been discharged home on 2/10. Patient to follow up with Outpatient Neuro PT Rehab as she is having some issues with mobility, gait, and overall functional mobility. She is using a 2 wheeled walker at this time.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/09/2021,02/09/2021,0.0,PUB,Unknown,Unknown,Unknown/none reported,,Lidocaine,"['Aphasia', 'Chest discomfort', 'Computerised tomogram normal', 'Crying', 'Dysarthria', 'Echocardiogram normal', 'Facial paralysis', 'Gait disturbance', 'Grip strength decreased', 'Hemiparesis', 'Magnetic resonance imaging normal', 'Mobility decreased', 'NIH stroke scale abnormal', 'Neurological symptom', 'Rash', 'Throat tightness', 'Tremor', 'Upper motor neurone lesion', 'Urticaria', 'Walking aid user']",1,PFIZER\BIONTECH,IM 1024415,HI,40.0,F,"--12/29/2020: Upon receiving the vaccination my heart rate plummeted to 45 BPM and suddenly raised to 134 BPM, thereafter stabilizing within 90 BPM. --01/02/2021: I felt extremely sick all of the sudden while at the same time my Watch triggered and alerted that my heart rate was in the 160's BPM and rising. I was rushed to ER where the medical staff fought to stabilize me and administered three doses of Adenosine to control my heart rate. Since 01/02/2021 I have been battling to control my heart rate with Propranolol. I have been to the ER multiple times weekly and have had numerous appointments with specialist at medical center--they are unable to diagnose me. They cannot find a reason for Tachycardia. Gastro, Endo, BH and Cardiology at medical center have many test, scans, echos, bloodwork and are unable to find cause let alone a solution.",Not Reported,,Yes,Yes,1.0,Not Reported,N,12/29/2020,01/02/2021,4.0,MIL,none,None,None,,penicilen,"['Blood test', 'Echocardiogram', 'Heart rate increased', 'Heart rate irregular', 'Laboratory test', 'Malaise', 'Scan', 'Tachycardia']",1,MODERNA,SYR 1024416,ND,79.0,F,"At 1207, resident was noted having facial twitching and seizures and crackles , Vitals: BP 199/95, O2 Sats 89% on RA, PR 88, Temp 97.3, RR was hardly counted because of body movement. Blood sugar was 172 mg/dL. Hooked on O2 at 4L per NC. Informed MD and ordered to send to ER. Family - were updated. Ambulance was called. Family clarified resident's status is DNR. Report was given to ER nurse. Updated ER that INR today is 5.5 and MD ordered to HOLD Coumadin till 02-11-21.",Not Reported,,Yes,Yes,2.0,Not Reported,N,02/08/2021,02/09/2021,1.0,SEN,Pravastatin Sodium Tablet 20 MG Give 20 mg by mouth one time a day related to OTHER HYPERLIPIDEMIA Vitamin D Tablet (Cholecalciferol) Give 2000 IU by mouth one time a day related to AGE-RELATED OSTEOPOROSIS WITHOUT CURRENT PATHOLOGICAL,No recent acute illnesses,"PAROXYSMAL ATRIAL FIBRILLATION, MALIGNANT NEOPLASM OF BLADDER, UNSPECIFIED, RESTLESSNESS AND AGITATION, ANXIETY DISORDER, UNSPECIFIED, HYPOMAGNESEMIA, OTHER HYPERLIPIDEMIA, ESSENTIAL (PRIMARY) HYPERTENSION, RESTLESS LEGS SYNDROME, HYPOKALEMIA, AGE-RELATED OSTEOPOROSIS WITHOUT CURRENT PATHOLOGICAL FRACTURE, ALZHEIMER'S DISEASE, UNSPECIFIED, CHRONIC KIDNEY DISEASE, STAGE 3 UNSPECIFIED, ALTERED MENTAL STATUS, UNSPECIFIED, OTHER SYMBOLIC DYSFUNCTIONS, LYMPHEDEMA, NOT ELSEWHERE CLASSIFIED , MUSCLE WEAKNESS (GENERALIZED), UNSPECIFIED PSYCHOSIS NOT DUE TO A SUBSTANCE OR KNOWN PHYSIOLOGICAL CONDITION",,"Codeine, Tramadol","['Blood glucose increased', 'Crepitations', 'Dyskinesia', 'International normalised ratio increased', 'Muscle twitching', 'Seizure']",2,PFIZER\BIONTECH,IM 1024420,CA,65.0,F,"Patient had the first Moderna Covid vaccine on Thursday 1/21/2021. She had a bit of sore arm on that day and the day after. On Saturday 1/23/2021, she had a fever of 100.5 F (11AM), nausea, light headache and chills. The temperature went down after she took ibuprofen. Patient's husband enrolled her to V-Safe to report all the adverse effects she experienced. On Sunday 1/24/2021, her temperature was 98.3F. She still had nausea and no appetite. She and her husband watched a football game in their bedroom upstairs. Husband noticed that his wife was pacing around the room many times. At 7Pm, Husband went downstairs for dinner but she refused to come down to eat. He went upstairs around 8pm, TV was still on. He turned off TV and went down stairs again thinking his wife felt as sleep while watching TV. He went back upstairs for bed around 10:30 PM. Husband said his wife had a deviated septum so she would snore very loudly when asleep. He didn?t hear her snoring so he went to check on her and found her not responsive. Husband called emergency services. Paramedic came at 10:45 and said patient was passed. Husband sent many texts to V-safe after that to report the incident. No response was received from V-safe. Patient?s doctor told her husband that she died due to cardiac arrest.",Yes,01/24/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/24/2021,3.0,PHM,,,Heart Disease,,,"['Cardiac arrest', 'Chills', 'Death', 'Decreased appetite', 'Headache', 'Nausea', 'Pain in extremity', 'Psychomotor hyperactivity', 'Pyrexia', 'Unresponsive to stimuli']",1,MODERNA,IM 1024451,AK,80.0,M,"CHF, Resp failure, intubated, on Levophed, suspected septic and cardiogenic shock.",Not Reported,,Yes,Yes,2.0,Not Reported,N,02/09/2021,02/10/2021,1.0,PVT,"Milrinone, Proair, albuterol, ASA, digoxin, insulin, Plavix, Coreg, Celexa, Protonix,",,"CHF, COPD, CAD, EF 25-35% 11/17, ICD, DM, Ischemic CM, Pulm HTN",,"Spironolactone, prednisone","['Cardiac failure congestive', 'Cardiogenic shock', 'Chest X-ray', 'Condition aggravated', 'Endotracheal intubation', 'Laboratory test', 'Respiratory failure', 'Sepsis']",UNK,PFIZER\BIONTECH, 1024460,OH,53.0,F,patient called approximately a month after the shot to report that her arm was still sore following the immunization. she stated that her arm was sore when she raised her arm. patient made and appointment with her pcp who sent her for an mri and referred her to a specialist. patient states she was told she will not be needing surgery but did receive a cortisone shot to try to help with the pain. the patient reported that the cortisone shot helped a little with the pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,10/13/2020,10/13/2020,0.0,PHM,,,,,glycerin and morphine,['Limb discomfort'],1,PROTEIN SCIENCES CORPORATION,IM 1024468,CA,49.0,F,"February 5th, Intense hives and itching and Swollen lips. Went to the ER. Was administered Diphenylhydramine twice, Epinephrine, famotidine, and Methylpred. Feb 6th, Same symptoms. Went back to ER. Was administered diphenhydramine, famotidine, and methylpred again. Feb 7th, Same Symptoms- face now also swollen and puffy. Was administered dexamethasone, diphenhydramine, famotidine. Feb 8th, Same Symptoms- hives spread to lower body and upper body, burning feeling. Went back to the ER. Was administered dexamethasone, diphenhydramine, epinephrine, famotidine.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/10/2021,02/04/2021,25.0,WRK,"Norvasc, Benicar",,,,,"['Blood test', 'Burning sensation', 'Lip swelling', 'Pruritus', 'Swelling face', 'Urticaria']",2,MODERNA,IM 1024477,TX,18.0,M,"He was given the Moderna COVID vaccine first dose on 1-15-2021. 2.5 weeks later he complained of constant abdominal pain that lasted two days. No fever/chills, nausea/vomiting, diarrhea/constipation, no visible blood in stool or urine, no abnormal color or volume of urine. No preceding illness of any kind. He is tested for COVID weekly at college and was always negative including on 1-16-2021 He went to a freestanding ER where CT Abd without contrast showed normal appendix but mesenteric adenitis. White count was normal but creatinine was 2.8! He was given 2 L of fluid and recheck showed Cr 2.8 again. Urine dipstick 2+ proteinuria and microscopic hematuria. He works out 6 days/week but nothing unusual in the recent workout history. CPK was normal. Serum myoglobin slightly elevated at 94. He doesn?t take supplements, creatine, drugs, energy drinks, coffee or any medications. He was advised to hydrate copiously which he did. He was admitted for work up two days later. Repeat Cr was 3.1. ESR was 45 and CRP 2.26. RF, ANA, ANCA negative. Complement levels C3 and C4 normal. Uric acid and LDH normal. Amylase and Lipase normal. UA showed no protein or blood. IVF given overnight and kidney biopsy planned for the next day depending on that mornings labs. That morning Cr came down to 2.4. PTH was 127, Vit D 12.7, Calcium normal. SPEP normal and UPEP normal. Urine drug screen normal. Kidney biopsy cancelled and he was discharged. Cr two days later (2-10-2021) was 1.68",Not Reported,,Not Reported,Yes,1.0,Yes,N,01/15/2021,02/03/2021,19.0,PVT,None,None,None,,None,"['Abdominal pain', 'Amylase normal', 'Antineutrophil cytoplasmic antibody negative', 'Antinuclear antibody negative', 'Blood calcium normal', 'Blood creatine phosphokinase normal', 'Blood creatinine increased', 'Blood lactate dehydrogenase normal', 'Blood parathyroid hormone increased', 'Blood uric acid normal', 'C-reactive protein increased', 'Complement factor C3', 'Complement factor C4', 'Complement factor normal', 'Computerised tomogram abdomen abnormal', 'Drug screen negative', 'Electrophoresis protein', 'Electrophoresis protein normal', 'Haematuria', 'Lipase normal', 'Lymphadenitis', 'Myoglobin blood increased', 'Proteinuria', 'Red blood cell sedimentation rate increased', 'Rheumatoid factor negative', 'SARS-CoV-2 test negative', 'Urine analysis abnormal', 'Urine analysis normal', 'Vitamin D decreased', 'White blood cell count normal']",1,MODERNA,IM 1024539,AZ,75.0,F,"patient tested positive for covid on 1/29/21. was hospitalized on 2/8/21 for shortness of breath, generalized weakness, nausea.",Yes,02/08/2021,Yes,Yes,8.0,Not Reported,N,01/15/2021,01/28/2021,13.0,PVT,"allopurinol, citalopram, sodium bicarb., furosemide, ascorbic acid, folic acid, pravastatin, vitamin D2, levothyroxine, potassium chloride, calcium carbonate, b complex, omega 3s, prednisone, levocetirizine, tumeric, krill oil, metoprolol","shoulder pain, dermatitis, chronic kidney disease, edema, gerd, venous insufficiency, hypertension, RA, hypothyroidism, osteoporosis, depression, radiculopathy, rosacea.",,,"alupent, coumadin, cephalexin, saccharin, gabapentin, codeine sulfate, sulpher, onion, perfumes and fragrances, adhesive.","['Asthenia', 'COVID-19', 'Dyspnoea', 'Nausea', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1024581,,36.0,F,"Developed ITP, currently in the hospital getting treated with dexamethasone 40 mg daily",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/09/2021,01/22/2021,13.0,PVT,No,Vasculitis,"History of renal transplant, on immunosuppression History of vasculitis on immunosuppression",,No,"['Full blood count', 'Immune thrombocytopenia', 'Platelet count decreased']",1,PFIZER\BIONTECH,IM 1024592,CA,80.0,F,No adverse reactions noted. Resident is on hospice for end of life care for terminal diagnosis cerebral atherosclerosis. Experiencing respiratory distress 2/10/2021 r/t to hospice prognosis.,Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,,02/02/2021,02/11/2021,9.0,SEN,"Allopurinol, Ativan, Vit B12, Colace, Ferrous Sulfate, Gabapen Gabapentin, Lansoprazole, LEvsin, Miralax, Mirtazapine, Morphine Sulfate, Multivitamin with minerals, Omeprazole, Senna, Trazadone, Valproic Acid, Vitamin C","acute pyelonephritis, acute respiratory failure","Metabolic Encephalopathy, Sepsis, anemia, neuropathy, chronic kidney disease, aspergers syndrome, hydronephrosis with uretral calculous obstruction, uterovaginal prolapse, obstructive and reflux uropathy, protein-calorie malnutrition, anxiety, major depressive disorder, gastro-esophageal reflux disese, diabetes mellitus 2.",,No known allergies,"['Cerebral arteriosclerosis', 'Respiratory distress']",UNK,UNKNOWN MANUFACTURER,IM 1024601,NY,58.0,F,Hypovolemic shock due to acute intrabdominal hemorrhage of uterine fibroid. Exploratory laparotomy and total abdominal hysterectomy and bilateral salpingo-oophorectomy completed within 12 hours of presenting symptoms,Not Reported,,Yes,Yes,,Not Reported,Y,01/24/2021,02/03/2021,10.0,PVT,"vitamin D, Calcium, multivitamin",,,,penicillin,"['Computerised tomogram abdomen abnormal', 'Exploratory operation', 'Haemoglobin decreased', 'Haemoperitoneum', 'Hypovolaemic shock', 'Hysterosalpingo-oophorectomy', 'Intra-abdominal haemorrhage', 'Platelet count normal', 'Uterine leiomyoma']",2,PFIZER\BIONTECH,IM 1024620,OR,60.0,F,"Severe fatique, chronic pain, headache, swollen lymphnodes, memory and other cognitive symptoms mainly with speech. This remains ongoing. Treatment: CuraPro, ProOmega, LDN",Not Reported,,Not Reported,Not Reported,,Yes,N,01/21/2021,01/21/2021,0.0,PUB,"Paxil, Amlodopine, Welbutrin, Calcium +D and Magnesium",,"Chronic Fatigue Syndrome, Fibromyalgia and migraines",,,"['Antinuclear antibody', 'Blood thyroid stimulating hormone', 'Cognitive disorder', 'Cognitive linguistic deficit', 'Fatigue', 'Full blood count', 'Headache', 'Lymphadenopathy', 'Memory impairment', 'Pain', 'Speech disorder']",1,MODERNA,IM 1024626,CA,81.0,M,DEATH ON 5TH DAY OF 2ND DOSE.,Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/06/2021,5.0,SEN,"amlodipine,aspirin,losartan,metformin,pravastatin,polyethylene glyco,Colace,cholecalciferol","N40.1 Benign prostatic hyperplasia with lower urinary tract symptoms(Primary, Admission), Z48.816 Encounter for surgical aftercare following surgery on the genitourinary system, M62.81 Muscle weakness (generalized), R26.2 Difficulty in walking, not elsewhere classified, R13.12 Dysphagia, oropharyngeal phase, R48.8 Other symbolic dysfunctions, I66.3 Occlusion and stenosis of cerebellar arteries, G95.20 Unspecified cord compression, I69.359 Hemiplegia and hemiparesis following cerebral infarction affecting unspecified side, M47.12 Other spondylosis with myelopathy, cervical region, I10 Essential (primary) hypertension, E78.5 Hyperlipidemia, unspecified, E55.9 Vitamin D deficiency, unspecified, E11.9 Type 2 diabetes mellitus without complications, I63.9 Cerebral infarction, unspecified, R33.9 Retention of urine, unspecified, D64.9 Anemia, unspecified, N18.9 Chronic kidney disease","N40.1 Benign prostatic hyperplasia with lower urinary tract symptoms(Primary, Admission), Z48.816 Encounter for surgical aftercare following surgery on the genitourinary system, M62.81 Muscle weakness (generalized), R26.2 Difficulty in walking, not elsewhere classified, R13.12 Dysphagia, oropharyngeal phase, R48.8 Other symbolic dysfunctions, I66.3 Occlusion and stenosis of cerebellar arteries, G95.20 Unspecified cord compression, I69.359 Hemiplegia and hemiparesis following cerebral infarction affecting unspecified side, M47.12 Other spondylosis with myelopathy, cervical region, I10 Essential (primary) hypertension, E78.5 Hyperlipidemia, unspecified, E55.9 Vitamin D deficiency, unspecified, E11.9 Type 2 diabetes mellitus without complications, I63.9 Cerebral infarction, unspecified, R33.9 Retention of urine, unspecified, D64.9 Anemia, unspecified, N18.9 Chronic kidney disease",,No known allergies,['Death'],7+,MODERNA,IM 1024627,LA,77.0,M,"covid shot 2/2; feel bad 2/5; covid positive diagnosis - 2/8 s/s cough, fever, shortness of breath , hypertension, afib (in er) - admitted went into DIC per intensivist 2/11 patient died",Yes,02/11/2021,Yes,Yes,,Not Reported,N,02/02/2021,02/05/2021,3.0,PHM,nothing,none,DVT - popliteal in 1995 hypertension hyperlipidemia,,nkda,"['Atrial fibrillation', 'COVID-19', 'Cough', 'Death', 'Disseminated intravascular coagulation', 'Dyspnoea', 'Feeling abnormal', 'Hypertension', 'Pyrexia']",1,MODERNA,IM 1024641,PA,70.0,M,"Sudden onset of acute respiratory failure with hypoxia and hyperglycemia Lungs filled with fluid, oxygen went down to low 80?s and coughing - could not breath. 911 Emergency to hospital.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,02/06/2021,02/07/2021,1.0,OTH,"Amiodarone 200mg 2xday,aspirin 81mg 1/day, digoxin 125mcg 1/day, mad-oxide 400 mg 2/day, metoprolol succinct er 50 mg 1/day, omega 3-dha-epa-fish oil 360 mg-144 mg-216 mg-1200 mgcpdr 1/day, sacubitril-Vallarta national 97-103 mg 2/day, spi","Heart failure - cardiac defibrillator in situ, non ischemic cardiomyopathy (HCC), VT (HCC) Sleep Apenea Prostrate nodule malignant neoplasm of prostrate (radiation not started yet). Chronic lumbar radiculopathy","Heart failure - cardiac defibrillator in situ, non ischemic cardiomyopathy (HCC), VT (HCC) Sleep Apenea Prostrate nodule malignant neoplasm of prostrate (radiation not started yet). Chronic lumbar radiculopathy",,None,"['Acute respiratory failure', 'Blood glucose increased', 'Blood test', 'Chest X-ray', 'Cough', 'Dyspnoea', 'Echocardiogram', 'Hyperglycaemia', 'Hypoxia', 'Influenza virus test negative', 'Legionella test', 'Oxygen saturation decreased', 'Pulmonary oedema', 'SARS-CoV-2 test negative', 'Viral test negative']",1,PFIZER\BIONTECH,SYR 1024643,FL,73.0,F,"1/21/2021, 48 hours after 1st dose, collapsed at home. Possibly triggered A Fib and went to ER with BP 180/110. CVA verified by MRI of brain. Drs suggested that Pradaxa was not strong enough to prevent stroke when A Fib was triggered. Anticoagulant changed to Eliquis.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,01/19/2021,01/21/2021,2.0,OTH,I have A Fib and took Pradaxa. 48 hours after 1 st vaccine I collapsed at home and went to the Er. MRI showed small area of clot in the brain. Was told I had a mild stroke. Changed medication to Eliquis.,no problems,"A Fib, Type II Diabetes, High cholesterol, High BP",,"tetracycline, metformin, trulicity, jardiance, tradjenta","['Angiogram cerebral', 'Arteriogram carotid', 'Atrial fibrillation', 'Cerebrovascular accident', 'Chest X-ray', 'Computerised tomogram head', 'Condition aggravated', 'Echocardiogram', 'Magnetic resonance imaging brain abnormal', 'Syncope']",1,PFIZER\BIONTECH,IM 1024662,TN,57.0,M,"On January 8, I started having a cramping feeling in my right calf. It went on throughout the day without a event. I woke up the next morning, and the crap was worse. I ran some errands and came home and then looked at my calf of my leg and it was twice the size as my other leg. I had four spots of bruising from ankle to knee. I immediately went to the emergency room. I was hospitalized and had bloodwork and an MRI done which showed that I had a DVT and a pulmonary embolus in my right lung. I was hospitalized for two days on blood thinners. I had no shortness of breath or heart problems during this time. I was then released from the hospital on blood thinners which I have to take for the next six months.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,12/29/2020,01/09/2021,11.0,PVT,"Fenofibrate 134mg, monteluast 10mg, Metoprolol ER 100mg, Vitamin D 50,000u, ASA 80mg, Norvasc 5mg, zetia10mg, magnesium supplement, cetrizine 10mg, vitamin c supplement, zinc supplement, krill oil supplement, folic acid 800mg supplement.",None,"Controlled HTN, hyperlipademia",,None,"['Blood test', 'Contusion', 'Deep vein thrombosis', 'Fibrin D dimer normal', 'Magnetic resonance imaging abnormal', 'Muscle spasms', 'Peripheral swelling', 'Pulmonary embolism']",1,PFIZER\BIONTECH,IM 1024665,NY,55.0,M,"Developed severe pleuritic chest pain x 5 days, went to ER on 2/5/2021, D Dimer over 4000, CT chest showed bilateral segmental and sub segmental Pulmonary Emboli. Initial Ultrasound of legs was negative for DVT, follow-up U/S on 2/9/2021 was positive for large Femoral vein DVT. All family history, medical history and other risk factors for coagulation disorder was negative. I was initiated on anticoagulation therapy. (Enoxaparin)",Not Reported,,Yes,Yes,2.0,Yes,U,01/30/2021,02/01/2021,2.0,PVT,None,None,None,,None,"['Angiogram pulmonary abnormal', 'Computerised tomogram thorax abnormal', 'Deep vein thrombosis', 'Fibrin D dimer increased', 'Lung consolidation', 'Pleuritic pain', 'Pulmonary embolism', 'Ultrasound Doppler abnormal']",2,MODERNA, 1024718,TN,76.0,M,"Seizure followed by loss of speech, weakness, confusion",Not Reported,,Not Reported,Yes,5.0,Yes,N,01/26/2021,01/26/2021,0.0,PUB,"Warfarin, Allopurinol, Flomax, Paxil, Gabapentin, Trazodone",,Vascular Disease,,,"['Aphasia', 'Asthenia', 'Computerised tomogram', 'Confusional state', 'Electroencephalogram', 'Laboratory test', 'Magnetic resonance imaging', 'Seizure']",2,MODERNA, 1024743,CA,74.0,F,"pt became lethargic, stopped eating. No fever; no nausea",Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/08/2021,7.0,SEN,"xalatan drops, cosopt drop, alphgan drops, Norco, Seroquel, dulcolax supp, Senna, depakote sprinkles, trazodone,",none,"vascular dementia, glaucoma, osteoporosis",,none known,"['Decreased appetite', 'Diet refusal', 'Lethargy']",UNK,PFIZER\BIONTECH,IM 1024748,NJ,62.0,F,"Jan 25- chills, fever, headache Jan. 27- obtained rapid and PCR COVID SWABS- which resulted negative Jan 30- started antibiotics from primary doctors with no relief of fevers. Jan 31 - Brought to ER And was admitted for observation . Multi Covid testing negative. Cat scan showed pneumonia picture. SARS COVID IGG was negative, but antibody for vaccine was positive",Not Reported,,Not Reported,Yes,5.0,Not Reported,,01/15/2021,01/25/2021,10.0,UNK,,,,,,"['Blood immunoglobulin G', 'Chills', 'Computerised tomogram abnormal', 'Headache', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 antibody test positive', 'SARS-CoV-2 test negative']",1,MODERNA,IM 1024779,NC,75.0,F,Patient stated she started experiencing vertigo after receiving the vaccine that was so intense that it woke her from sleep. She stated she required hospitalization for several days.,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/21/2021,01/22/2021,1.0,UNK,,,,,,"['Sleep disorder', 'Vertigo']",UNK,PFIZER\BIONTECH,IM 1024788,MO,90.0,F,Pt had passed away before second dose given.,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,,01/13/2021,01/25/2021,12.0,SEN,,,,,,['Death'],2,MODERNA,IM 1024790,MO,91.0,F,Pt had passed away before second dose given.,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,,01/13/2021,01/25/2021,12.0,SEN,,,,,,['Death'],2,MODERNA,IM 1024791,VA,74.0,M,"Patient developed severe thrombocytopenia, consistent with ITP. He was admitted to the hospital with this condition on 2/1/21 after developing diffuse petechiae, ecchymoses, epistaxis, and gingival bleeding over the preceding few days. He required steroids, IVIG, and rituximab. Initial platelet count on admission 2000, dropped as low as undetectable to 1000. Normalized/improved to 164,000 after 9 days in the hospital and multiple treatments. NOTE: patient had a prior episode of ITP in 2011. Please note date of Covid-19 vaccine and manufacturer are not certain.",Not Reported,,Yes,Yes,10.0,Not Reported,Y,01/25/2021,02/01/2021,7.0,UNK,"sertraline, docusate, melatonin, pantoprazole, senna",,"Chronic Lewy Body dementia, depression, frailty",,adhesive tape,"['Blood creatinine normal', 'Blood urea normal', 'Ecchymosis', 'Epistaxis', 'Gingival bleeding', 'Glomerular filtration rate decreased', 'Haemoglobin decreased', 'Immune thrombocytopenia', 'Immunoglobulin therapy', 'Petechiae', 'Platelet count decreased', 'Thrombocytopenia', 'White blood cell count normal']",UNK,MODERNA, 1024795,MO,86.0,F,Pt had passed away before second dose given.,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,,01/13/2021,01/25/2021,12.0,SEN,,,,,,['Death'],2,MODERNA,IM 1024817,GU,68.0,M,"Patient was coded and expired Code Blue: Patient was in dialysis, after 30 minutes his sbp dropped to 60s he was given 4 albumin. Patient who was responsive before that became unresponsive, had seizure like activity, lost pulse and spontaneous breathing. HD stopped. Code called. Cpr started. A few minutes into cpr patient started to profusely bleed - gi bleed and ventilation became very hard., intubation was very difficult and ventilation hard as we suctioned large amounts of aspirated blood. Patient was eventually intubated. More than 8 doses of epi ws given, sodium bicarbonate * 2 given with continuous cpr. It was mostly PEA with one shockable rhythym. And shock delivered for vfib. patient continued to profusely bleed, og insertion was not successful and effective ventilation was very tough due to massive aspiration,. Possible variceal rupture with cpr from his cirrhosis is likely scenario. After 30 minutes of unsuccessful ventilation and acls protocol. Code was stopped.",Yes,02/12/2021,Not Reported,Yes,2.0,Not Reported,N,02/11/2021,02/12/2021,1.0,PVT,"Meds Prior to hospitalization: Propanolol, cilostazol, duloxetine HCL DR 30","NIDDM, HTN, CAD s/p CABG x4v, liver cirrhosis, ESRD on HD, cataracts, dysarthria, PAD s/p angioplasty 2020 bilateral lower extremity",social history of alcohol abuse,,Ampicillin sodium,"['Aspiration', 'Blood pressure systolic decreased', 'Cardio-respiratory arrest', 'Death', 'Dialysis', 'Endotracheal intubation', 'Gastrointestinal haemorrhage', 'Mechanical ventilation', 'Pulse absent', 'Pulseless electrical activity', 'Respiratory arrest', 'Resuscitation', 'Seizure like phenomena', 'Unresponsive to stimuli', 'Ventricular fibrillation']",1,PFIZER\BIONTECH,IM 1024853,MA,78.0,F,"Feb 8 states she had a cold. Feb 9 added stomach ache and nausea. Feb 9 visited urgent care facility for exam and Covid-19 test. Rapid test results were negative. Appeared tired but fine. Told to go home and rest. Feb 10 at 9:00 am found dead on the floor in pool of blood and aspirated. Excessive blood in toilet, pooled on floor and hallway rug.",Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/08/2021,9.0,PVT,Chemo,Essential Thrombocytopemia Alzheimer?s,Essential Thrombocytopemia Alzheimer?s,,None,"['Abdominal pain upper', 'Aspiration', 'Death', 'Fatigue', 'Haemorrhage', 'Nasopharyngitis', 'Nausea', 'SARS-CoV-2 test negative']",UNK,MODERNA,SYR 1024882,CA,71.0,M,02/03/2021 The next day after the Covid 19 (Moderna) injection my dad felt chills thru out his body around 7:00 pm he took a Tylenol we assumed it was just a side effect from vaccine. At on or around 8:45 PM my dad called my sister that he was having trouble breathing and felt very short of breath. My sister was there in about 7min by the time she got to him my dad was gasping for air he would lift his head up trying to breath. They got him to the hospital shorty after about a 7 min drive. My dad was taken into hospital we were not able to go in due to restrictions.,Not Reported,,Yes,Yes,4.0,Not Reported,N,02/02/2021,02/03/2021,1.0,PUB,Alfuzosin 10 mg Omprazole 40 mg Amlodipine 5 mg 2X a day Docusate sodium 100 mg Metoprolo ER 200 mg 24 Hr-XL Benazepril 40 mg,,Hypertension Abdominal pain no confirm diagnosis,,NKDA,"['Blood culture positive', 'Chest X-ray', 'Chills', 'Dyspnoea', 'SARS-CoV-2 test negative', 'Sepsis']",1,MODERNA,IM 1024884,CA,38.0,F,"elevated heart rate, tingling arms and back, severe back pain",Not Reported,,Not Reported,Not Reported,,Yes,N,01/30/2021,02/01/2021,2.0,UNK,none,none,none,,Macrobid,"['Back pain', 'Heart rate increased', 'Paraesthesia']",1,MODERNA,SYR 1025151,,71.0,M,shortness of breath,Not Reported,,Not Reported,Yes,,Not Reported,U,02/08/2021,02/09/2021,1.0,OTH,,,,,,['Dyspnoea'],UNK,PFIZER\BIONTECH,IM 1025155,,65.0,M,"generalized weakness, type II ischemia",Not Reported,,Not Reported,Yes,,Not Reported,U,02/01/2021,02/07/2021,6.0,OTH,,,,,,"['Asthenia', 'Ischaemia']",UNK,PFIZER\BIONTECH,IM 1025472,CA,65.0,M,"Patient received COVID19 vaccine at clinic at 11:52 am, discharge post treatment stable. Got home around 2:30 pm went to bed. He usually got tired post dialysis. He did not wake up at 6 pm. His wife went check on him. found patient cold and unresponsive. 911 pulseless PEA. ER Medical hospital. Pronounced death at 7:40 pm",Yes,02/10/2021,Not Reported,Yes,,Not Reported,N,02/10/2021,02/10/2021,0.0,OTH,,,,,,"['Death', 'Dialysis', 'Fatigue', 'Peripheral coldness', 'Pulse absent', 'Unresponsive to stimuli']",1,MODERNA,IM 1031138,,54.0,F,"Headache, Myalgia, Fever, Angina, declined 2nd dose",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/05/2021,01/05/2021,0.0,OTH,,,,,,"['Angina pectoris', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 1024885,CA,29.0,F,"Rash is circular around injection site, red, itchy welts, about 3 inches in diameter. Showed up 8 days after vaccine. No other symptoms. Probably a delayed harmless allergic reaction, but still thought it might be useful to report. Immediately following vaccine I only had a little pain at injection site and no rash or redness. This just popped up today out of nowhere but it?s right at the injection site and my arm has been covered all day and was not exposed to any new foods, products, etc. After a full day and Benadryl, redness has gone down slightly",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/11/2021,8.0,PVT,"Mirena IUD, Women?s one a day multivitamin",None,None,,Pecans and walnuts only,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,SYR 1024886,LA,74.0,F,"?Covid Arm? itching, blotchy redness, heat, raised rash, and stinging sensitivity in upper arm of vaccine injection site. Same symptoms (to a lesser degree) appeared in the opposite upper arm as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/13/2021,7.0,PHM,"Lisinopril/HCTZ 20/12.5 mg X 2, Levothyroxine 150 mcg, Metoprolol 100 mg, Rosuvastatin 10 mg, Buproprion Hcl XL150 mg, probiotics, omega XL",None,"High blood pressure, hypothyroidism, hypercholesterolemia",,None known,"['Injection site discomfort', 'Injection site erythema', 'Injection site pruritus', 'Injection site rash']",UNK,MODERNA, 1024887,VA,50.0,F,"reports fever blister within 1 hour that resolved and didn't require immediate treatment. next day developed myalgias but then came into the ED due to a feeling of tongue swelling and swelling of the neck, no n/v/d, no sob/wheezing/stridor",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/11/2021,1.0,OTH,,,"depression, dsypepsia",,citrus fruits,"['Blister', 'Myalgia', 'Pyrexia', 'Swelling', 'Swollen tongue']",2,PFIZER\BIONTECH,IM 1024889,CA,67.0,M,"Starting 7 days after vaccination the injection site has a 1.5 in diameter redness, is warm, slightly tender, and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/09/2021,7.0,OTH,Lovastatin Metformin Losartin,,Type 2 Diabetes Hypertension,,,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,MODERNA,SYR 1024890,CA,63.0,F,Redness hard lump rash itchy painful to touch,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/11/2021,10.0,OTH,Blood pressure,,Hypertension fibromyalgia,,None,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site rash']",2,MODERNA, 1024892,WA,59.0,F,"Mouth sores on roof of mouth and cheek (white/very sore) about 1 week after injection. Tongue sores (red/swollen/sore) on both sides and tip of tongue + a fizzing feeling on top of the tongue starting about 10 days after injection. Fizzing feeling on roof of mouth (opposite side to previous sore) at same time as tongue sores. At this date, the roof of mouth and cheek sores are healed, but the tongue sores have spread and make eating and talking challenging. Additional side effects - Increased asthma for 7 days after injection - treated with Albuterol and Dulera. Tiredness and chills within first 2 days of injection Sore upper arm for 2 days, followed by continued soreness in elbow.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/02/2021,4.0,OTH,Alprazolam Gabapentin Estradiol Albuterol Centrum Silver Vitamins,,"Asthma Migraine headaches Anxiety Back, hip and knee pain",,"Sulfa Morphine Dust, grass, tree pollen","['Arthralgia', 'Chills', 'Fatigue', 'Glossodynia', 'Limb discomfort', 'Oral pain', 'Swollen tongue', 'Tongue erythema']",1,PFIZER\BIONTECH,SYR 1024893,CA,25.0,F,"I developed red, itchy blotches on the right side of my stomach approximately 1.5 weeks after my first Moderna dose. I did not take any medications to treat these symptoms and they have faded away for the most part. There is significantly less redness and no longer an urge to scratch. I have not experienced any other serious adverse reactions. I was advised to see an allergist, however, my insurance requires that I see my PCP to get a prior auth/referral for an allergy specialist. The allergist that is contracted with the Super POD has a 50+ person waitlist and I will be going to my local urgent care to see a provider.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/27/2021,13.0,PUB,None,None,None,,None,"['Rash macular', 'Rash pruritic']",1,MODERNA,IM 1024946,WI,74.0,F,"angioedema, lip paresthesia, tongue swelling, dry eyes, chest tightness",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,PHM,"Albuterol, ASA, biotin, Wellbutrin, klonopin, Vit B -12 injections, Lasix, amaryl, insulin, lisinopril, Prilosec, potassium, fish oil, multivitamin, metoprolol, metformin, Claritin, relafen",none,"HTN, DM, hyperlipidemia, gerd, IBS",,"latex, seasonal allergies","['Angioedema', 'Chest discomfort', 'Dry eye', 'Electrocardiogram normal', 'Irritable bowel syndrome', 'Paraesthesia oral', 'Swollen tongue']",UNK,PFIZER\BIONTECH,IM 1024999,,,F,"Admitted to the hospital with multiple small strokes; Feeling fatigue; Headache; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced being admitted to the hospital for multiple small strokes, fatigue and headache. The patient's medical history was not included. Products known to have been used by the patient were not provided. On 21 Jan 2021, prior to the onset of the events, the patient received the first of planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On an unknown date, Shortly after the mRNA-1273 vaccine was given, the patient experienced fatigue and headache which was attributed to vaccine side effect. On 27 Jan 2021, the patient was admitted to the hospital with multiple small strokes. No other treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, fatigue, headache and being hospitalized with multiple small strokes, is unknown.; Reporter's Comments: This case concerns a 79 year-old, female patient, who experienced events of multiple small strokes, fatigue and headache. The events of fatigue and headache occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. The event of stroke occurred approximately 6 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current available limited information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/21/2021,01/27/2021,6.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical history not provided),,,"['Cerebrovascular accident', 'Fatigue', 'Headache']",1,MODERNA, 1025000,IL,92.0,M,"right sided pneumonia; having difficulty breathing; cyanotic; coughing; sounded congested; A spontaneous report was received from a nurse concerning a 92-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right sided pneumonia, difficulty breathing, cyanotic, cough and sounded congested. The patient's medical history, as provided by the reporter included Alzheimer's, hypertension, arteriosclerotic heart disease, hyperlipidemia, benign prostatic hyperplasia, prostate cancer, covid-19, allergy to aricept and exelon. The concomitant medications reported included atorvastatin, tamsulosin hydrochloride, paracetamol, macrogol 3350, furosemide and ipratropium bromide/salbutamol sulfate for unspecified indications. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 039k208) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 08 Jan 2021, the patient was on droplet isolation due to possible exposure of Covid 19 and received duoneb treatments for chronic nonproductive cough. The patient also received honey consistency fluids. On 19 Jan 2021, the patient's droplet precautions were discontinued. On 26 Jan 2021, after receiving the vaccine, the patient experienced difficulty breathing, cyanotic, cough and sounded congested following which the patient was repositioned. The lab findings included oxygen saturation at 78 percent on room air, so oxygen was applied at 2L which increased oxygen saturation at 88 percent, so oxygen was increased to 4L and oxygen saturation increased to 95percent, body temperature at 103.1 degree Fahrenheit, blood pressure 188/110 mmHg, respiratory rate at 28 breaths per minute, pulse rate at 128 heartbeat per minute. The patient was then sent to the Hospital emergency room (ER) where he was diagnosed with right sided pneumonia. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, right sided pneumonia, difficulty breathing, cyanotic, cough and sounded congested was unknown.; Reporter's Comments: This case concerns a 92-year-old, male patient. The patient's medical history od Alzheimer's, hypertension, arteriosclerotic heart disease, prostate cancer, covid-19, on duoneb treatments for chronic nonproductive cough remains as contributing factors. Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,12/29/2020,01/26/2021,28.0,UNK,ATORVASTATIN; FLOMAX [TAMSULOSIN HYDROCHLORIDE]; TYLENOL; MIRALAX; LASIX [FUROSEMIDE]; DUONEB,"Alzheimer's disease; Arteriosclerotic heart disease; BPH; Drug allergy (Aricept, Exelon); Hyperlipidemia; Hypertension",Medical History/Concurrent Conditions: COVID-19; Prostate cancer,,,"['Blood pressure measurement', 'Body temperature', 'Cough', 'Cyanosis', 'Dyspnoea', 'Heart rate', 'Oxygen saturation', 'Pneumonia', 'Pulmonary congestion', 'Respiratory rate']",1,MODERNA,OT 1025001,,,U,"Bell's palsy after 7 days first dose; A regulatory report was received from a physician, concerning an unknown patient of unknown age and gender, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced ""Bell's palsy after 7 days first dose"". The patient's medical history was not provided. Concomitant medication reported included metformin. On an unknown date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), for COVID-19 infection. On an unknown date, after 7 days from first dose, the patient developed Bell's palsy. No treatment information was reported for the event. Action taken with second dose of mRNA-1273 in response to the event was not reported. The outcome of the event "" Bell's palsy"", was unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender, who experienced a serious event of Facial paralysis approximately 7 days after first dose of mRNA-1273, lot # unknown. Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Facial paralysis'],1,MODERNA,OT 1025002,VA,,F,"Wobbly; Sees double; BP dropped; Fluid behind ears; Lower back pain; Ear infection; Severe Vertigo; Dizziness; A spontaneous report was received from a consumer who was also a 81-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe vertigo (vertigo), dizziness, ear infection, fluid behind her ears (middle ear efflusion), being wobbly (gait disturbance), seeing double (diplopia), lower back pain (back pain), and blood pressure dropped (blood pressure decreased). The patient's medical history included arthritis and migraine. Products known to have been used by the patient included fluticasone propionate/ salmeterol xinafoate, botulinum type A, duloxetine hydrochloride, hydrochlorothiazide (HCTZ), umeclidinium bromide, atorvastatin calcium, gabapentin, raloxifene, sumatriptan, telmisartan, cetirizine hydrochloride, cholecalciferol, calcium, zinc, probiotics, apoaequorin, and galcanezumab-gnlm. On 14 Jan 2021, the patient saw an ear doctor for ear pain. Treatment included steroids and eardrops that were antibiotics. On 23 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, approximately 3 days after the mRNA-1273 vaccine was given, the patient noted she started getting severe vertigo or dizziness. On 28 Jan 2021, she saw her physician who attributed the dizziness to an ear infection that went undiagnosed. She also had fluid behind her ears. On 28 Jan 2021, a different doctor informed her that her eardrops were not going to touch the ear infection she had and prescribed amoxicillin. She reported that she still has dizziness. She stated that she was still wobbly and sees double. She then saw an ophthalmologist for her double vision and his concern was that it was not an eye issue more of a head issue and should be checked for a transient ischemic attack (TIA) or stroke. She then went to the emergency room (ER) to get it checked out and left the ER after waiting over 2 hours. The triage nurse at the ER told her that she was beyond any help since it was after 90 minute window if she had a stroke. She was attempting to get a CT scan of her head done. She was given pain medication as well for lower back pain. She was taken off the HCTZ because blood pressure dropped after getting the vaccine. Consent to contact was obtained. Treatment information included amoxicillin, meclizine and pain medication. Action taken with mRNA-1273 was not reported. The outcome of the events, severe vertigo, and/or dizziness, ear infection, fluid behind her ears, being wobbly and seeing double, lower back pain and blood pressure dropped, was not resolved.; Reporter's Comments: Based on the information provided the event of ear infection is unlikely related to the vaccine administration as event was pre-existing , Although a temporal association exist between the other events and mRNA-1273, critical details is lacking as patient is of an advanced age and has an undisclosed cardiac condition (on treatment with HCTZ ). . Hence, there is not enough information to adequately assess association with mRNA-1273 at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/26/2021,3.0,UNK,ADVAIR; BOTOX; CYMBALTA; HCTZ; INCRUSE; LIPITOR; NEURONTIN; RALOXIFENE; SUMATRIPTAN; TELMISARTAN; ZYRTEC ALLERGY; VITAMIN D3; CALCIUM; ZINC; PROBIOTICS NOS; PREVAGEN [APOAEQUORIN],Arthritis,,,,"['Back pain', 'Blood pressure decreased', 'Diplopia', 'Dizziness', 'Ear infection', 'Gait disturbance', 'Middle ear effusion', 'Vertigo']",1,MODERNA,OT 1025003,WA,58.0,F,"Pneumonia; Partial left lung collapsed; Injection site cellulitis, red rash around injection site which was tender and itchy; A spontaneous report was received from a consumer, who was a 58-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced injection site cellulitis, red rash around injection site which was tender and itchy (injection site cellulitis), cough, pneumonia, and partial left lung collapse (pneumothorax). The patient's medical history was not provided. Concomitant medications were not reported. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for COVID-19 infection. On an unspecified date, a few days after vaccination administration, the patient experienced red rash around the injection site which was tender and itchy and was diagnosed by a nurse as cellulitis, which later resolved. On 14 Jan 2021, the patient began coughing. On 18 Jan 2021, the patient went to urgent care for a COVID-19 test and the results came back negative. The patient was prescribed dexamethasone for three days, but symptoms did not improve. She again went to urgent care where X-rays was performed which showed pneumonia and partial left lung collapse, she was prescribed erythromycin. On 24 Jan 2021, patient went to emergency room and was given amoxicillin and advised to see their doctor. On 27 Jan 2021, her doctor prescribed prednisone and the symptoms started to get better. Action taken with mRNA-1273 in response to the events was not reported, although the patient expressed concern about getting the second injection. The outcome of events, cough, pneumonia, and partial left lung collapse (pneumothorax), was reported and resolving. The event, injection site cellulitis, red rash around injection site which was tender and itchy, was reported as resolved.; Reporter's Comments: Although a temporal association exist, the report lacks critical details such as the patient's medical history and concomitant medications. Noting that cellulitis and pneumonia are usually caused by an infectious agent, both events are considered unlikely associated with mRNA-1273. Pneumothorax is confounded by the pneumonia.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Chest X-ray', 'Injection site cellulitis', 'Pneumonia', 'Pneumothorax', 'SARS-CoV-2 test']",1,MODERNA,OT 1025004,FL,,F,"Respiratory distress; Difficulty breathing; A spontaneous report was received from a pharmacist concerning an 84-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced respiratory distress and difficulty breathing. The patient's medical history, as provided by the reporter, included heart disease, osteoporosis, osteoarthritis, gastroesophageal reflux disease, hypothyroidism, hypertension and history of anemia. No relevant concomitant medications were reported. On 26 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot Number:029K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, within an hour of vaccination, patient had respiratory distress and difficulty breathing. The patient was treated with diphenhydramine and epinephrine, the patient was intubated and was taken to the hospital. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, respiratory distress and difficulty breathing unknown.; Reporter's Comments: This case concerns an 84-year-old female patient with medical history of heart disease, who received their first of two planned doses of mRNA-1273 (Lot 029K20A), and who experienced the serious unlisted events of Respiratory distress and Dyspnoea. The events occurred within one hour of vaccination. Based on the current available information and temporal association between vaccine administration and the onset of events on the day of vaccination, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/26/2021,01/26/2021,0.0,UNK,,,"Medical History/Concurrent Conditions: Anemia; Gastroesophageal reflux disease; Heart disease, unspecified; Hypertension; Hypothyroidism; Osteoarthritis; Osteoporosis",,,"['Dyspnoea', 'Respiratory distress']",1,MODERNA,OT 1025005,,,F,"Fainted during the night; I had chills with a high fever; A spontaneous report was received from a female consumer, age not reported who experienced ""chills with a high fever"", and ""fainted during the night"" after receiving the second dose of mRNA-1273. The patient's medical history was not reported. Concomitant product use was not reported. On 27-Jan-2021 prior to the onset of symptoms, the patient received her second dose of mRNA-1273, route, site and Batch number not reported, for prophylaxis of Covid-19 infection. The patient reported a bad reaction approximately after ten or eleven hours after her immunization, she had chills with a high fever and then fainted during the night. She reported that she did come to a moment later. On 29-Jan-2021 she reported that she is feeling fine that day. The patient stated that she felt it was an unusual reaction that should be reported. Treatment for the event was not reported. Action taken with the study drug due to the events ""chills with a high fever"", and ""fainted during the night was not reported. The events ""chills with a high fever"", and ""fainted during the night"", were considered recovered/resolved on 29-Jan-2021.; Reporter's Comments: This case concerns a female patient, who experienced events of chills with a high fever, and fainted during the night. The events occurred 10-11 hours after the second and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/28/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Pyrexia', 'Syncope']",1,MODERNA,OT 1025006,CA,89.0,F,"began seeing hallucinations; A spontaneous report was received from a consumer concerning a 89-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and began seeing hallucinations. The patient's medical history was not provided. No relevant concomitant medications were reported. On 01 Feb 2021, about 4 hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 01 Feb 2021, about 4 hours after receiving the vaccine, the patient began seeing hallucinations. She was seeing moss grow on the walls and real bright turquoise colors that turn pink. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event began seeing hallucinations was unknown.; Reporter's Comments: This case concerns a 89 year-old, female patient, who experienced event of hallucinations. The event occurred 4 hours after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Hallucination'],1,MODERNA,OT 1025007,NJ,21.0,F,"Rapid eye movement like ""having a mini-seizure""; Fainted; Feeling warm; A spontaneous report (United States) was received from a pharmacist concerning a 21-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fainted and experienced to have rapid eye movement like ""having a mini-seizure"" and feeling of warmth. The patient's medical history included historical seizures. Concomitant product use was not provided by the reporter. On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number:026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 02 Feb 2021, a few minutes after the injection, the patient fainted then recovered but again fainted and was noted to have rapid eye movement like ""having a mini-seizure"". HCP managed her with ice pack as patient complained of feeling warm and she recovered in less than 30 minutes. Treatment information was not provided. The outcome for events fainted, rapid eye movement like ""having a mini-seizure"""" and feeling warm were resolved.; Reporter's Comments: This spontaneous report concerns a 21-year-old, female patient with historical seizures. who received experienced the patient fainted then recovered but again fainted and was noted to have rapid eye movement like ""having a mini-seizure."" The event occurred a few minutes after the administration of mRNA-1273 vaccine (Batch number: 026L20A, expiration date: unknown). Treatment administered include Icepack and outcome is resolved. Based on the information provided which includes a strong temporal onset between the vaccine administration and the event, a causal association cannot be excluded. However, event is confounded by the subject's history of seizures. Feeling warm is consistent with the safety profile of the product.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Seizures,,,"['Feeling hot', 'Seizure', 'Syncope']",1,MODERNA,OT 1025009,NY,52.0,F,"meniere's ringing in right ear; head felt fuzzy; unable to concentrate; Nausea; Vomiting; Vertigo; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included HTN and Meniere's disease. Patient was not pregnant at the time of vaccination. Concomitant medication included amlodipine and hydrochlorothiazide. No other vaccine was received in the four weeks. The patient experienced head felt fuzzy, unable to concentrate, Meniere's ringing in right ear, nausea and vomiting, vertigo on 25Jan2021 10:30. Events resulted in emergency room/department or urgent care. Meclizine, IV Fluids, Maalox and Zofran were given as treatment for the adverse events. Outcome of the events was recovered. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.; Sender's Comments: The patient had medical history of Meniere's disease. The reported event was more likely due to underlying disease, and less likely causally related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,PVT,AMLODIPINE; HYDROCHLOROTHIAZIDE,,Medical History/Concurrent Conditions: Hypertension; Meniere's disease,,,"['Disturbance in attention', 'Feeling abnormal', 'Nausea', 'Tinnitus', 'Vertigo', 'Vomiting']",UNK,PFIZER\BIONTECH, 1025010,WA,88.0,M,"Throwing up foamy stuff; Oxygen saturation was in the 80%s; confused; This is a spontaneous report from a contactable nurse. An 88-year-old male patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3302), intramuscular at the right arm on 25Jan2021 02:30 at a single dose for COVID-19 immunization. The vaccine was administered in a Nursing Home. No other vaccine was given to the patient in four weeks. Medical history included Parkinsons, dementia, diastolic heart failure and known allergies: Iodine, Propranolol. Concomitant medication included paracetamol (TYLENOL), melatonin, quetiapine fumarate (SEROQUEL), ropinirole and sertraline hydrochloride (ZOLOFT). On 26Jan2021 11:30 AM, the patient was throwing up foamy stuff and his oxygen saturation was in the 80%s and was confused. The events led to Emergency room/department or urgent care visit. Treatment was given for the events. The patient has no COVID-19 prior to vaccination. He was tested for COVID-19 on 26Jan2021 with Nasal Swab, Rapid Test and the result was negative. The outcome of the events was unknown.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/26/2021,1.0,SEN,TYLENOL; MELATONIN; SEROQUEL; ROPINIROLE; ZOLOFT,,Medical History/Concurrent Conditions: Dementia; Diastolic heart failure; Iodine allergy; Parkinson's disease,,,"['Confusional state', 'Oxygen saturation', 'Oxygen saturation decreased', 'SARS-CoV-2 test', 'Vomiting']",1,PFIZER\BIONTECH,OT 1025011,MN,85.0,M,"This morning at 6 am his blood pressure was 156/74, with 65 beats. Then, at 7am, it was 167/76, with 65 beats. Then at 8:40 am, his blood pressure was 137/64, with 65 beats. So it is fluctuating; This morning at 6 am his blood pressure was 156/74, with 65 beats. Then, at 7am, it was 167/76, with 65 beats. Then at 8:40 am, his blood pressure was 137/64, with 65 beats. So it is fluctuating; feel light headed and it's been coming on and off/feeling dizzy and light headed; This is a spontaneous report from a contactable consumer (patient). An 85-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EK4176, via an unspecified route of administration in his left upper arm, on 22Jan2021 at single dose for COVID-19 immunization. Medical history included surgery on aorta to put a stent in Nov2020. There were no concomitant medications. On 26Jan2021 at mid day the patient started to feel dizzy and light headed and this feeling has been coming on and off, so he decided to take his blood pressure. He didn't have his values from 26Jan2021. In the morning of 27Jan2021 at 6 am his blood pressure was 156/74, with 65 beats, then, at 7am, it was 167/76, with 65 beats and at 8:40 am, his blood pressure was 137/64, with 65 beats, so it was fluctuating. At the time of the report the events had not resolved yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/26/2021,4.0,UNK,,,Medical History/Concurrent Conditions: Aortic stent insertion; Aortic surgery,,,"['Blood pressure fluctuation', 'Blood pressure measurement', 'Dizziness', 'Heart rate', 'Systolic hypertension']",1,PFIZER\BIONTECH, 1025012,NJ,,M,"Erectile Dysfunction; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (Age: 62; Unit: Unknown) received bnt162b2 (BNT162B2), first dose (lot: EL0142) via an unspecified route of administration on 05Jan2021 at single dose, second dose (lot: EN5318) via an unspecified route of administration on 26Jan2021 (administered between 1:00-2:30PM) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced erectile dysfunction on an unspecified date. The patient asked What is the mRNA half life. He stated that he received the Pfizer vaccine on the 5th and the second on the 26th. He was asking if there were any reports of erectile dysfunction after receiving the vaccine. He also asked if the ingredient Hexane was a poison, if this is safe. The patient had some questions, he is really worried because he has seemed to be experiencing something. He is wondering if Erectile Dysfunction has been reported as a problem from the COVID vaccine. He seemed to be experiencing worsening of his sexual function, and the only thing that is new that he can think, is that he got the vaccination. He received the second dose of the product on 26Jan2021. He asked how long the MRNA last in your system, how many people were involved in the study, When did it start, if the hexane solvent in the vaccine affect your testes. It was further reported that he was having a bad reaction he believe to the vaccination (Covid Vaccine) and asked if there were any reports of erectile dysfunction or sexual dysfunction regarding males from the vaccine. The patient had an article here it says your system mounts a response against the new protein, because they are seen as foreign invaders, developing antibodies that are specific to SARS-CoV-2 in the process. These infection fighters tick around to help your body fight a future case of Covid-19 but it's not yet understood for how long and this is the sense he wanted to talk to about that body will do its thing and eventually will get rid of the protein or mRNA on its own? The patient said since he had taken the COVID-19 Vaccine injections he has experienced worsening erective dysfunction. He asked if anyone else has reported having that issue since receiving the COVID-19 Vaccine. He was advised he would be transferred to Medical Information for further assistance. He stated he is so sad, and started crying while speaking with the agent. He declined to answer any further questions and asked to be transferred to Medical Information to have his question addressed. He asked the agent if she knew that Hexane is in the Pfizer COVID- 19 Vaccine. He said he did not realize Hexane was in the COVID-19 Vaccine before he got the vaccine. The outcome of the event was unknown. No follow-up attempts are possible. No further information expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,,,UNK,,,,,,['Erectile dysfunction'],1,PFIZER\BIONTECH, 1025013,CA,70.0,F,"blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumping to my head and became very hot; face turned red and was hot to the touch; facial muscles became weak on both; difficult to make facial expressions; my mouth began to tremble; chills; facial muscles became weak on both; difficult to make facial expressions; This is a spontaneous report from contactable consumers. An 70-year-old female non-pregnant patient received her first dose bnt162b2 (BNT162B2; Solution for injection; lot number: EL9283) via an unspecified route of administration at Left arm on 28Jan2021 12:30 at single dose for COVID-19 immunisation at Clinic. Medical history included high blood pressure, high cholesterol. Concomitant medication included rosuvastatin calcium (CRESTOR), amlodipine, calcium carbonate simethicone. There was no other vaccines in four weeks. The patient previously took iodine had contrast, procaine hydrochloride (NOVOCAIN) had drug allergy, omeprazole (PRILOSEC) and had drug allergy, olmesartan medoxomil (BENICAR) had drug allergy. Five minutes after the injection 28Jan2021 12:35, patient felt blood pumping to her head and became very hot. Her face turned red and was hot to the touch. Then, facial muscles became weak on both sides and made it difficult to make facial expressions. Lastly, her mouth began to tremble and had chills. Symptoms subsided about 30 minutes after the injection. she worried about getting the second injection. The patient received treatment with Liquids/electrolytes. The events result in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,PUB,CRESTOR; AMLODIPINE; CALCIUM CARBONATE;SIMETICONE,,Medical History/Concurrent Conditions: Blood pressure high; High cholesterol,,,"['Chills', 'Erythema', 'Facial paralysis', 'Feeling hot', 'Reduced facial expression', 'Sensation of blood flow', 'Tremor']",1,PFIZER\BIONTECH, 1025014,WA,39.0,F,"difficulty speaking; intermittent outer ear & mastoid pain & separate timing of pulsatile whistling noise; intermittent outer ear & mastoid pain & separate timing of pulsatile whistling noise; intermittent outer ear & mastoid pain & separate timing of pulsatile whistling noise; Day 1 L cheek numbness- resolved; unable to lift eyebrow-blink eyelid; unable to lift eyebrow-blink eyelid- smile symmetrically, puff cheek on left; Onset unable to drink without spilling liquid; Patient recieved COVID 19, Pfizer on 11Jan2021, Patient is pregnant (delivery date: 27Feb2021); Patient recieved COVID 19, Pfizer on 11Jan2021, Patient is pregnant (delivery date: 27Feb2021); Patient recieved COVID 19, Pfizer on 11Jan2021, Patient is pregnant (delivery date: 27Feb2021); This is a spontaneous report from a contactable physician (patient). A 39-year-old female patient received first dose of BNT162B2 (COVID 19, Pfizer, Solution for injection, Lot number: EH9899) via an unspecified route of administration on Left arm on 11Jan2021 19:15, at single dose for covid-19 immunisation. Medical history included pregnancy related anemia, hemorrhoids at 32 weeks. Covid prior vaccination was reported as no. Known allergies reported was none. Concomitant medication included first dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP, Lot number: 57C57) (Boostrix) on 22Dec2020 (other vaccine 4 weeks) on Left Arm for immunization. Other medications in two weeks included meclozine hydrochloride, pyridoxine hydrochloride (PNV), iron, docusate sodium (COLACE), hydrocortisone supp. Patient stated, ""onset unable to drink without spilling liquid, no wrinkles, unable to lift eyebrow-blink eyelid- smile symmetrically, puff cheek on left. Day 1 L cheek numbness- resolved Day 3. Day 2 difficulty speaking, that night intermittent outer ear & mastoid pain & separate timing of pulsatile whistling noise. Day 4 able to partially puff cheek, improved again Day 6 - not fully able yet. Day 5 able to move eyelid slightly"". The patient experienced 'unable to lift eyebrow-blink eyelid', 'puff cheek on left', 'onset unable to drink without spilling liquid' on 24Jan2021 19:00, 'day 1 l cheek numbness- resolved' on 25Jan2021, 'difficulty speaking' and 'intermittent outer ear & mastoid pain & separate timing of pulsatile whistling noise' on 26Jan2021. The events resulted in disability or permanent damage. No treatment was received for the events. The patient experienced exposure during pregnancy on 11Jan2021 19:15. Last menstrual date was 23May2020. The gestational period was 33 weeks. The mother (patient) was due to deliver on 27Feb2021. Outcome of 'Maternal exposure during pregnancy, third trimester', 'Drug use in unapproved population' and 'Off label use' was unknown while other events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. It is noted that Drug use in unapproved population. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/11/2021,01/11/2021,0.0,PVT,PNV; IRON; COLACE; HYDROCORTISONE,,Medical History/Concurrent Conditions: Anemia of pregnancy; Hemorrhoids,,,"['Corneal reflex decreased', 'Dysphagia', 'Ear pain', 'Facial paralysis', 'Hypoaesthesia', 'Mastoid disorder', 'Maternal exposure during pregnancy', 'Off label use', 'Product use issue', 'Speech disorder', 'Tinnitus']",1,PFIZER\BIONTECH, 1025079,NE,90.0,M,Patient found by family in his home deceased on the morning of 02/10/2021.,Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/10/2021,1.0,PVT,albuterol-ipratropium 2.5mg-0.5mg/3mL nebulizer QID amiodarone 100mg PO daily amlodipine 2.5mg PO daily PRN high blood pressure aspirin 81mg PO daily Symbicort 160mcg-4.5mcg/inh 2 puffs BID calcitriol 0.25mcg PO on M-W-F carvedilol 12.5m,None known,Aortic Stenosis Coronary Artery Disease asthma Hypertension cardiac pacemaker COPD Chronic kidney disease diastolic heart failure hyperlipidemia thrombocytopenia,,No known allergies,['Death'],2,MODERNA,IM 1025081,VA,61.0,M,No reported adverse reactions from 1st or 2nd vaccine doses Patient died on 2/6/2021 at Correctional facility- autopsy was performed at medical examiner's office. The COD was artherosclerotic cardiovascular disease,Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/06/2021,2.0,OTH,"Amlodipine 5mg, asprin 81mg, atorvastin 10mg, cinacalet 120mg daily, sevelamer 800mg, Nephrocaps (MVT)",,"ESRD on HD, HCV cirrhosis, refractory ascites, CAD, CHF (EF15%-20%), hyperparathyroidism",,"Bactrin, NSAIDS","['Arteriosclerosis', 'Autopsy', 'Condition aggravated', 'Death']",2,MODERNA,IM 1025117,FL,92.0,M,"Fever, chills, debilitating weakness, atrial fibrillation, renal effects",Not Reported,,Yes,Yes,8.0,Not Reported,N,01/29/2021,01/30/2021,1.0,SEN,"Cardiac, Renal, Type 2 Diabetes, Parkinsonian",None,"Cardiac, Renal, Type 2 Diabetes, Parkinsonian, Waldenstrom",,None,"['Asthenia', 'Atrial fibrillation', 'Chills', 'Condition aggravated', 'Pyrexia', 'Renal disorder']",1,PFIZER\BIONTECH,IM 1025123,FL,75.0,F,"Jan 18 COVID vaccine usf 11:30 am pfizer vaccine first dose, starting feeling bad: headache the next day had class collapsed and stubbed toe, bleeding etc. ambulance came and assessed, PT felt so weak could not stand but was declared ok to drive by emt, got home and collapsed on the floor and crawled around for 6 days, lived on boiled eggs and rice cakes, doctor said call an ambulance, ambulance picked her up and took her to hospital, hospital took care of her for 16 days, got discharged yesterday (2-9-2021)",Not Reported,,Not Reported,Yes,16.0,Not Reported,U,01/18/2021,01/19/2021,1.0,UNK,Armor thyroid 10mg vitamin pill (multivitamin) Alieve every once in a while Probiotic for children,,,,"Sensitivities to food and medications,: goes into anaphylactic shock Yeast allergy wheat meat quinine mushroom penicillin","['Asthenia', 'Balance disorder', 'Dysstasia', 'Feeling abnormal', 'Gait disturbance', 'Haemorrhage', 'Headache', 'Limb injury', 'Mobility decreased', 'Syncope', 'Weight bearing difficulty']",1,PFIZER\BIONTECH,IM 1025299,FL,86.0,F,Systemic: Other- Patient died - cause unknown; 1 day,Yes,,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/10/2021,3.0,SEN,,,,,,['Death'],2,PFIZER\BIONTECH,IM 1025300,WI,75.0,M,"75 year old M, worsening weakness for the past several weeks. Seems to have gotten worse since Monday when he had his first Covid vaccine here at the hospital. Denies any headaches or neck pain. No fevers or chills. No cough or shortness of breath. No abdominal pain. No vomiting or diarrhea. No black or bloody stools. No dizziness. Today he almost fell and the son had to catch him. He did not suffer any trauma. He offers no symptoms of pain. Here he is fully awake and alert. Nothing to clinically suspect a stroke. His vitals are stable. Chest x-ray shows nothing acute. Creatinine is better than baseline. Electrolytes are stable. Troponin reassuring. He had no chest pain or shortness of breath to suspect angina. Spoke to the wife via telephone, he is getting so weak that he was unable to walk. Paramedics report they had lift him as he could not take a step. He was unable to ambulate here in the emergency room. At this time it does not seem like I can safely discharge him home.",Not Reported,,Not Reported,Yes,10.0,Not Reported,N,02/01/2021,02/01/2021,0.0,PVT,allopurinoL (ZYLOPRIM) 300 MG tablet Take 300 mg by mouth Daily. amiodarone (PACERONE) 200 MG tablet 1 tablet by mouth Daily. aspirin 81 mg chewable tablet Take 81 mg by mouth Daily. bisacodyl (DULCOLAX) 5 mg EC tablet 10 mg by mouth Dai,See chronic problem list below,"Hypertension (*) Hypothyroid (*) Type 2 diabetes mellitus with diabetic polyneuropathy (*) Posterior tibial tendon dysfunction Atherosclerosis Malignant neoplasm of urinary bladder (*) Malignant neoplasm of urinary organ (*) Paroxysmal A-fib (*) CKD (chronic kidney disease) stage 3, GFR 30-59 ml/min Hypercholesteremia (*) Diabetes (*) H/O carpal tunnel repair Total knee replacement status Gout OSA (obstructive sleep apnea) Psoriasis (*) Vitamin D deficiency Depression (*) History of asthma Colon polyps Tremor Acquired pes planus of both feet Acquired keratoderma Hammertoe Abnormal chest x-ray Mycotic toenails Unsteady gait Macrocytosis Microalbuminuria Post-nasal drip Type 2 diabetes mellitus with microalbuminuria (*) Spondylosis of lumbar region without myelopathy or radiculopathy Atypical atrial flutter (*) Coronary artery disease due to calcified coronary lesion (*) Localized edema Longstanding persistent atrial fibrillation (*) S/P CABG x 3 11/19/2016 Status post Maze operation for atrial fibrillation/Cox Maze IV On amiodarone therapy Bilateral carotid artery stenosis (*) Ischemic cardiomyopathy (*) Chronic atrial fibrillation (*) Stenosis of right carotid artery (*) Closed sternal manubrial dissociation fracture with nonunion Atelectasis, right Bradycardia Iron deficiency anemia Medication intolerance Hematuria Generalized weakness Acquired palmar and plantar hyperkeratosis Cholelithiasis History of actinic keratoses RBBB Chronic diastolic heart failure (*)",,"Remicade [Infliximab]Itching RosuvastatinOther (See Comments) SimvastatinOther (See Comments) NaproxenItching, Rash","['Asthenia', 'Blood creatinine', 'Blood electrolytes normal', 'Chest X-ray normal', 'Condition aggravated', 'Gait disturbance', 'Gait inability', 'Troponin']",1,PFIZER\BIONTECH,IM 1025313,PA,,M,"DRESS syndrome; Presistant fever; Rash; Eosinophilia; A spontaneous report was received from a physician concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and subsequently developed Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome. The patient's medical history was not provided. Concomitant product use was not reported. On 05 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. After vaccine administration, the patient subsequently developed persistent fevers, rash, and new eosinophilia. The reporter stated being concerned for possible DRESS related to the vaccine. The patient was urgently referred to dermatology for a skin biopsy. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, DRESS, was unknown.; Reporter's Comments: This case concerns a male patient of unknown age who experienced a serious unexpected event of eosinophilia and systemic symptoms (DRESS) syndrome, including persistent fevers, rash, and new eosinophilia. The event occurred with unknown latency after first dose of mRNA-1273 on 05 Jan 2021. No further information available. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Drug reaction with eosinophilia and systemic symptoms', 'Eosinophilia', 'Pyrexia', 'Rash']",1,MODERNA,OT 1025330,AZ,87.0,M,"On 1/26 at breakfast table began vomiting. Continued thru am when at noon a caregiver did his O2 saturation and found it was 75%. This was confirmed, and resent sent to ER .",Yes,02/10/2021,Not Reported,Yes,16.0,Not Reported,N,01/25/2021,01/26/2021,1.0,SEN,"Amlodipine 5 mg po daily, docusate 100 mg BID,Eliquis 5 mg po BId, Omeprazole 20 mg po daily,Zinc 220mg po daily",None,Dementia,,None,"['Oxygen saturation decreased', 'Pneumonia aspiration', 'Vomiting']",1,MODERNA,IM 1025363,OH,40.0,F,"About 12 hours after the vaccine I developed headache, fever 100.5, nausea and vomiting, and red rash across my chest up to my neck and under both breasts. All symptoms but the rash improved the following day. I went to have my 8 week pregnancy US 6 days after this second vaccine dose and there was no fetal heart rate. The baby measured 8.7mm and there should be a heart rate when the baby measures >7mm. I had all of my pregnancy symptoms up through the day of the vaccine and then they disappeared the day my vaccine symptoms improved. I do not have a history of miscarriage.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/06/2021,1.0,PVT,Folic acid 800mg,none,no,,no,"['Abortion spontaneous', 'Foetal heart rate abnormal', 'Headache', 'Nausea', 'Pyrexia', 'Rash', 'Rash erythematous', 'Ultrasound uterus abnormal', 'Vomiting']",2,PFIZER\BIONTECH,IM 1025378,MD,67.0,F,"On Christmas day I was working and then you started feeling like a pinching in my chest, like when you are going to catch a cold, that went on through the afternoon. In the afternoon I started with light headache and dry cough (intermittent), no temperature. I did not take anything for it and continued working. When I got home, I felt weak and was supposed to join my family for Christmas and decided not to go. And went to sleep. The next day (Sat) I was still not feeling well, weakness on my limbs, I went to the hospital to see if I could get checked and they told me to return on Monday because Occupational Health was closed on the weekends. I went home and treated myself with Tylenol and Vitamin C. On Monday I got tested and was positive. By then, I was coughing, limbs weak, had temperature (101F). I started to get weaker an weaker and Tuesday or Wednesday my work called me and asked me if I would like to come see a doctor. Wednesday I started with shortness of breath. I called my PCP and he prescribed me an albuterol inhaler. It helped me but my cough got worse by Saturday. My doctor then told me to go to the hospital (I live by myself). At my choice I went to Medical Center and were admitted and was hospitalized for 6 days. They kept treating me with inhaler and oxygen. They wanted to send me to rehab but I told them I wanted to go home. I came home with oxygen and with albuterol inhaler and the ambulance had to bring me home. I still was feeling very weak, had cough, and had the shortness of breath. And I have been home since then. I have home health and a therapist that come check on me 2X a weekly.",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,12/22/2020,12/25/2020,3.0,PVT,Lovastatin 20mg,2 months before the vaccine I had shingles and went to the doctor and took prescription it cleared up.,No,,No,"['Asthenia', 'Blood test', 'Body temperature increased', 'Chest discomfort', 'Cough', 'Dyspnoea', 'Headache', 'Malaise', 'Muscular weakness']",1,PFIZER\BIONTECH,SYR 1025380,MD,50.0,M,"1/12/21 Stomach started feeling uncomfortable 1/13/21 Stomach pains and by the evening I started to have a fever, chills, and sweats. 1/14/21 Stomach pains, fever, chiills, sweats, and body aches continued. 1/15/21 Severe stomach pains, fever, chills and body aches. Responded to Health Clinic. Rapid COVID test was negative and per the request of the Doctor I responded to the Emergency Room located at Medical Center. Rapid COVID test negative, Bloodwork completed, CT test conducted, Appendicitis and I had to have an emergency Laparoscopic Appendectomy.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/11/2021,01/12/2021,1.0,OTH,"Metformin, Atorvastaton, Pantoprazole, Gabapendin, Ozempic Pen, Indomethacin","Diabetes, High cholesterol, gout","Diabetes, Hight Cholesterol, Gout, Colon Colitis, Kidney Stones, Back Fusion, Neck Fusion, Knee Problems, Gall Bladder Removed, Hernia Repairs (2x), Vasectomy, LSAIK, Tonsils Removed, Testicle Cyst Removed, History of Colitis, and Colon Cancer - Oncology.",,2007 Chemotherapy Treatment,"['Abdominal discomfort', 'Abdominal pain upper', 'Appendicectomy', 'Appendicitis', 'Blood test', 'Chills', 'Computerised tomogram', 'Hyperhidrosis', 'Laboratory test', 'Laparoscopic surgery', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",UNK,MODERNA,SYR 1025398,IL,77.0,F,Patient received vaccine on 2/5. We were told on 2/9 that the patient visited another emergency department on 2/6 but no information was given as to what prompted that visit. She was sent home. Daughter found her on 2/6 or 2/ 7 unresponsive and she died.,Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/07/2021,2.0,PVT,,,"COPD, type II diabetes, HTN",,"Latex, Abilify, Gadolinium contrast media","['Death', 'Unresponsive to stimuli']",1,MODERNA,IM 1025399,WA,88.0,F,Systemic: Heart Attack-Severe,Not Reported,,Not Reported,Yes,,Not Reported,N,02/10/2021,02/10/2021,0.0,SEN,,,,,,['Myocardial infarction'],1,PFIZER\BIONTECH,IM 1025404,TX,52.0,F,"after my injection, a few hours later, i started having a stiff shoulder. it has now become frozen shoulder. i contacted my doctor and let her know. i cant use my left arm. extremely painful. no range of motion.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/10/2021,02/10/2021,0.0,PUB,,,,,sulfa,"['Arthralgia', 'Joint range of motion decreased', 'Musculoskeletal stiffness', 'Pain', 'Pain in extremity', 'Periarthritis']",1,MODERNA,SYR 1025416,MN,90.0,M,Following day after receiving COVID 19 vaccine patient experience strong abdominal pain and weakness requiring ER visit.,Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/10/2021,02/11/2021,1.0,PVT,"ASA, Keflex, Clopidogrel, Lisinopril, Nitroglycerin, Propranolol, Atorvastatin, Vitamin D3, MTV, Lutein",,"Significant advanced basal cell carcinoma of his face, Dementia",,Hmg-COA-r inhibitors,"['Abdominal pain', 'Asthenia', 'Computerised tomogram head', 'Full blood count', 'Metabolic function test', 'SARS-CoV-2 test', 'Urine analysis']",1,MODERNA,IM 1025460,CA,72.0,M,"Patient went to bed totally fine and woke up saying he could not see in one eye. I rushed him to the emergency hospital they ran cat scans, MRI, heart tests etc. He stayed overnight while they checked. The next day we went to eye doctor who told him he had a eye stroke. He would regain some of his site not all of it. Something to do with blood clot or loss of blood to the eye. I was not satisfied with that so made another drs appointment for the next day with a different eye doctor. The first eye doctor gave us some blood test to do so we did it then. Later that evening we got an emergency call form the first eye doctor to get back to the hospital right away he could lose sight in the other eye.. They found some high c-reactive protein. Normal is 8 his was over 40. They put him on heavy steroids and did biopsy on both temples of his eyes. This started last Wednesday morning. He was released from the hospital Monday Morning to see his regular doctor that afternoon. Test results for the eye would be Tuesday and all other vital tests came back fine thank goodness. On Tuesday the biopsy tests also came back negative so they are stopping steroids. I think they were looking for auto immune issues. Today we are going to Rheumatologist",Not Reported,,Not Reported,Yes,3.0,Yes,N,01/19/2021,02/03/2021,15.0,OTH,"Atenolol 50 MG, Hydrochlorothiazide 25 MG/half daily, Lisinopril 20MG, Metformin ER 500MG, Simvastatin 10mg, asprin 8.1 mg, One touch Verio test strip, Onetouch Delica Plus 30g Lancets. Vitamins Super B complex, VitaminC, D3, E, Mature mul",None,"Hight blood pressure, arthritis, diabetes, gout sometimes.",,no,"['Biopsy', 'Blindness', 'Blindness unilateral', 'C-reactive protein increased', 'Cardiac function test', 'Cardiovascular evaluation', 'Computerised tomogram', 'Eye swelling', 'Magnetic resonance imaging', 'Optic ischaemic neuropathy', 'Red blood cell sedimentation rate increased', 'Retinal artery occlusion']",UNK,MODERNA, 1025463,PA,67.0,F,"Diarrhea, vomiting, rash, mild hives, chills, episode of delirium",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/05/2021,02/06/2021,1.0,PVT,,,,,,"['Chills', 'Delirium', 'Diarrhoea', 'Rash', 'Urticaria', 'Vomiting']",2,PFIZER\BIONTECH,IM 1025479,PA,29.0,F,"I had a pretty high fever of 102. I?m also experiencing a headache, chills, injection site pain, nausea and vomiting.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,WRK,,,,,,"['Chills', 'Headache', 'Injection site pain', 'Nausea', 'Pyrexia', 'Vomiting']",2,MODERNA,SYR 1025481,WV,73.0,M,"After receiving the vaccination her husband met with his son. He reported that his dad did not know anything. His wife told the son to bring him to Hospital. They brought him to the hospital and got there and his son said that he had called the daughter and he did not know the day, month, his grandson's name, like he wasn't there. He had a funny look on his face that he was ""out of it"". Asked simple questions about pet at home, favorite and could not remember the name of the cat. He then came out and said that he was fine. They ran tests for a mini-stroke, CT scan, blood work. They had a consult with Neurology, virtual. The neurologist did some questioning, and by 3:00 they felt that it was like a mini-stroke, and she said that she felt it was from the vaccination as it occurred right after the vaccine. She took him home, and told him to take a nap. By 4:30 PM she woke him up and said that they were going to eat, she was getting things ready. He was sitting on the couch about 5:00 PM and had that blank stare again. He went walking through the house walking aimlessly and started fumbling through papers . She called 9-1-1 and within 10 minutes they took him to the ER. It took her an hour to get to the hospital, his daughter met them at the ER. He told them that he was fine, and they knew that he was not. By 7:00 PM they were going to do an MRI and wanted to admit him to the hospital. All of a sudden at 9:00 he was having another episode. She got the nurse and they watched him and decided that he was having a seizure, (agitation, not making sense.). The entire episode lasts for about 30 minutes. They did an MRI and an EEG, which she does not have the results of. On 2/11/21 she talked to the neurologist who insisted it was due to the vaccine. He has now settled down and has not had another seizure since 9:00 PM the night before. He was discharged yesterday at around 1:00 PM, he slept, got up and is fine this morning. He was diagnosed with seizures, and to FU with Dr. in Epilepsy clinic, and prescribed Keppra, which he has not taken as he feels it was due to the vaccination.. He does not remember the events that took place.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/10/2021,02/10/2021,0.0,PHM,"Baby aspirin, Plavix, Atacand, Cardizem CD, Tricor, Lasix, Neurontin, Metformin, Lopressor, Crestor.",None.,"Heart attack in 2011 with stent placement, high blood pressure, high cholesterol, diabetes.",,None,"['Abnormal behaviour', 'Agitation', 'Blood test', 'Computerised tomogram', 'Disorientation', 'Electroencephalogram', 'Magnetic resonance imaging', 'Memory impairment', 'Mental status changes', 'Patient elopement', 'Seizure', 'Staring']",2,MODERNA,IM 1025489,CT,84.0,F,"Patient received 1st dose of vaccine on 2/6/21. That afternoon, developed malaise and fever/chills over the next few days. On the evening on 2/9/21, began to have left-sided chest pain (severe, pleuritic, radiating to left arm) leading her to seek medical care. Was determined to have viral pericarditis and admitted to the hospital for several days",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/06/2021,02/09/2021,3.0,PUB,"Carvedilol, Humalog, Iron tablets, levothyroxine, metformin, omeprazole, pravastatin, Toujeo, valsartan/HCTZ",,"hypertension, hyperlipidemia, DM2",,"Levemir, sitagliptin","['Cardiomegaly', 'Chest pain', 'Chills', 'Computerised tomogram thorax', 'Computerised tomogram thorax abnormal', 'Electrocardiogram normal', 'Malaise', 'N-terminal prohormone brain natriuretic peptide increased', 'Pain', 'Pain in extremity', 'Pericardial effusion', 'Pleuritic pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Troponin normal', 'Vena cava embolism', 'Viral pericarditis', 'White blood cell count normal']",1,PFIZER\BIONTECH,IM 1025493,AR,65.0,F,Patient expired on the morning of 2/11/2021. No known adverse events prior to death. Patient was observed for 20 to 25 minutes after administration of vaccine and reported experiencing no signs or symptoms of adverse events at that time.,Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/11/2021,2.0,PHM,"Multiple prescription medications, but drug/dose/directions are unknown.",Cancer,Cancer,,Unknown,['Death'],1,MODERNA,IM 1025497,PA,95.0,M,Disseminated Intravascular Coagulation Platelets = 19 Elevated Liver Enzymes. Bleeding coagulopathy Anemia Tachycardia Elevated white blood count,Not Reported,,Not Reported,Yes,,Not Reported,U,01/19/2021,01/27/2021,8.0,PVT,"ASA 81 mg, Atenolol, Lasix, Terozosin, Lovastatin, Amlodipine, Bacitracin oint",None,"Afib, T2DM, Hyperlipidemia, BPH, CKD stage 3, Peripheral Edema, Pulm HTN,",,None,"['Activated partial thromboplastin time prolonged', 'Anaemia', 'Coagulopathy', 'Disseminated intravascular coagulation', 'Fibrin D dimer increased', 'Haematocrit decreased', 'Haemoglobin decreased', 'Hepatic enzyme increased', 'International normalised ratio increased', 'Platelet count decreased', 'Prothrombin time prolonged', 'Tachycardia', 'White blood cell count increased']",1,MODERNA,IM 1025510,PA,58.0,F,"facial/ tongue swelling, hives, shortness of breath, trouble swallowing",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/11/2021,02/11/2021,0.0,SEN,"Apixaban, Metoprolol, Multivitamin, Rosuvastatin",,Paroxysmal atrial fibrillation OSA (obstructive sleep apnea) Hypertension Dyslipidemia Hypothyroid,,NKA,"['Dysphagia', 'Dyspnoea', 'Swelling face', 'Swollen tongue', 'Urticaria']",UNK,PFIZER\BIONTECH, 1025518,TX,33.0,F,"LEFT ARM NEUROPRAXIA/NEUROPATHY ... PATIENT WITH COMPLETE NUMBNESS TO LEFT ARM, WEAKNESS TO LEFT ARM.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/09/2021,02/10/2021,1.0,PVT,NONE,NONE,NONE,,NONE,"['Computerised tomogram head', 'Electrocardiogram normal', 'Hypoaesthesia', 'Muscular weakness', 'Nerve injury', 'Neuropathy peripheral']",UNK,PFIZER\BIONTECH,IM 1025574,,63.0,F,"Fever, Angioedema, SkinRash, Rash, UrticariaPruritus & HYPOtension Narrative: 2nd Vaccine 2/3: within 3 hours developed itchy rash all over, high fever 102.5 and went to ER, was admitted 2/5 discharged 2/6, blood pressure kept dropping was given IV fluids and steriods, and her legs are still swollen, hands cannot make a fist, she was swollen everywhere.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/03/2021,02/03/2021,0.0,OTH,,,,,,"['Angioedema', 'Blood pressure decreased', 'Hypotension', 'Peripheral swelling', 'Pruritus', 'Pyrexia', 'Rash', 'Rash pruritic', 'Swelling', 'Urticaria']",2,MODERNA,IM 1025579,LA,76.0,F,"Patient received the vaccine at an outside healthcare facility on 2/11/21. At approximately 1 pm she screamed out and fell out of her chair. EMS was called and patient was found to be in Vfib. ACLS was performed for approximately 42 minutes prior to arrival at ED. At that time the patient had been pulseless for 25 minutes. Patient received 450 mg of amiodarone, epinephrine x7, sodium bicarbonate x2, and 7 AED shocks. In the ED 3 more doses of epinephrine were given, one more dose of sodium bicarbonate, and 5 additional shocks. ROSC was not achieved and time of death was called at 1416.",Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,PVT,"amlodipine 5 mg daily, aspirin 81 mg daily, atorvastatin 40 mg daily, candesartan 32 mg daily, fluoxetine 20 mg daily, furosemide 40 mg daily, calcium carbonate/vitamin D, ascorbic acid, latanoprost ophthalmic solution, metformin 500 mg da",none reported,"coronary artery disease, history of CABG, history of MI, hypertension, COPD, polymyalgia rheymatica, hypercholesterolemia, hear failure, carotid artery stenosis, type 2 diabetes, morbid obesity, rheumatoid arthritis, panlobar emphysema (on 3L home O2)",,NKA,"['Atrial fibrillation', 'Cardioversion', 'Death', 'Fall', 'Life support', 'Pulse absent', 'Screaming', 'Ventricular fibrillation']",1,PFIZER\BIONTECH,IM 1025585,AL,67.0,M,"Lost all muscle control. couls not sit up stand or walk: stroke likwe symptoms hospitalized 3 days Cat scan, EKG, MRI, heart monitor",Not Reported,,Yes,Yes,2.0,Not Reported,Y,02/08/2021,02/09/2021,1.0,OTH,"Lisinopril, Finasteride, Atorvastatin, Probenicid with Colchemine, 81 mg aspirin, Eliquis, Metformin, Januvia, Fenofibrate, Tamsulosin","Covid 19 Decmber 2020, negative result on Dec 24 2020",Heart disease Diabetes,,None known of,"['Blood test', 'Cardiac monitoring', 'Chest X-ray', 'Computerised tomogram head', 'Dysstasia', 'Electrocardiogram', 'Gait inability', 'Magnetic resonance imaging brain', 'Mobility decreased', 'Muscular weakness', 'Neurological symptom']",1,MODERNA,IM 1025594,SC,72.0,F,"Patient contracted Covid and was hospitalized 10 days after 1st vaccine and stayed in hospital for 7 days. Symptoms included fever, nausea, dizziness, and shortness of breath.",Not Reported,,Not Reported,Yes,7.0,Not Reported,Y,01/18/2021,01/28/2021,10.0,PHM,unknown,unknown,unknown,,none,"['COVID-19', 'Dizziness', 'Dyspnoea', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1025609,TX,61.0,M,"5 minutes after injection, patient started complaining of sever chest pressure, shortness of breath. EKG was done and EMS was called. Patient was transported to ED since he continues to exhibit shortness of breath and still complaining of chest pain/pressure.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,OTH,Albuterol sulfate HFA 90 mcg inhaler every 4 hours as needed Hydroxyzine HCL 25 mg tablet at bedtime Symbicort 80 mcg inhaler twice a day,none,COPD,,Morphine Sulfate,"['Chest discomfort', 'Chest pain', 'Dyspnoea', 'Electrocardiogram ST segment elevation']",2,MODERNA,IM 1025641,NE,85.0,M,"Complained of dizziness on January 18,th seen by MD this date. Passed away on 22nd.",Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/18/2021,7.0,SEN,"Levothyroxine, Metformin, Tamsulosin",No other vaccinations no other illnesses,diabetes,,"Aspirin, Simvistatin, Tamsulosin","['Death', 'Dizziness']",1,PFIZER\BIONTECH,IM 1026004,PA,54.0,F,"Fever; Severe vomiting; Chills; Headache; Arm was sore; Fatigue; A spontaneous report was received from a medical assistant, concerning herself, a 54-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed sore arm, fever, severe vomiting, headache, chills and fatigue. The patient's medical history included COVID-19 at the end of Oct-2020. Concomitant product use was not provided by the reporter. On 25-Jan-2021 at 07:50 AM, the patient received their first of two planned doses of mRNA-1273 (Lot # 012L20A) in the left arm for prophylaxis of COVID-19 infection. On 25-Jan-2021, late in the afternoon, after the first dose of vaccine, the patient got headache and her arm was sore. The same evening, she experienced chills, fever of 100.7 Fahrenheit (was high in the hospital) and severe vomiting. Hence, she was hospitalized for two days from 25-Jan-2021 to 27 Jan 2021 and was treated with acetaminophen, fluids, ondansetron and potassium. On 28-Jan -2021, patient still had a little bit of headache and fatigued. Action taken with mRNA-1273 in response to the events were not provided. The outcome of the events, headache and fatigue were considered not resolved at the of this report. The outcome of the events, sore arm, fever, severe vomiting and chills were resolved on 27-Jan-2021. The reporter did not provide an assessment of the events, headache, sore arm, chills, fever, severe vomiting and fatigue.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information will be requested.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/25/2021,01/25/2021,0.0,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Chills', 'Fatigue', 'Headache', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,MODERNA,OT 1026005,MD,59.0,M,"Facial paralysis; Bradycardia; Weakness on his right arm and right leg; Difficulty talking; Can�t close eyes; Right leg is numb; Severe headache; Some eye issues, sees blurry; A spontaneous report was received from a paramedic, who was also a 59-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right arm and right leg, right leg is numb, can't close eyes, and bradycardia. The patient's medical history was not provided. Concomitant product use reported included, insulin, statin, losartan, and metformin. On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 07 Jan 2021, after receiving the vaccine, the patient experienced eye issues and would see blurry and had a severe headache. On 23 Jan 2021, the patient was hospitalized for 36 hours because he thought he was having a stroke. Test results showed the patient did not have a stroke. The patient did, however, experience facial paralysis, couldn't close his eyes, bradycardia, weakness in the right arm and right leg, difficulty talking, and his right leg felt numb. Treatment for the events included prednisone, valaciclovir, and unspecified calming medication while at the hospital. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right am and right leg, right leg is numb, can't close eyes, and bradycardia, was considered not resolved.; Reporter's Comments: This case concerns a 59 year old male was hospitalized with a serious events of some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right arm and right leg, right leg is numb, can't close eyes, and bradycardia after first dose to mRNA-1273 in the left arm. Comcomitant medications include insulin, metformin, atorvastatin, losartan. Hospital work-up showed ne did not have a stroke, and he was treated with prednisone, valaciclovir and a ""calming medicine"". b) Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. + b) Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/07/2021,01/07/2021,0.0,UNK,INSULIN; METFORMIN; STATIN [ATORVASTATIN CALCIUM]; LOSARTAN,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Bradycardia', 'Eyelid disorder', 'Facial paralysis', 'Headache', 'Hemiparesis', 'Hypoaesthesia', 'Speech disorder', 'Vision blurred']",1,MODERNA,OT 1026006,TX,68.0,M,"Cellulitis; A spontaneous report was received from a consumer concerning a 68-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis. The patient's medical history was not provided. No relevant concomitant medications were reported. On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced cellulitis from the vaccine. No further details were provided. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event cellulitis was unknown.; Reporter's Comments: This case concerns a 68 year-old, male patient, who experienced event of cellulitis. The event occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. Based on the current available limited information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Cellulitis'],1,MODERNA,OT 1026007,,,M,"Had a syncopal event; A spontaneous report was received from a health care provider who is also the patient, a male of unreported age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a syncopal episode. The patient's medical history was not provided. No relevant concomitant medications were reported. On 17 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 17 Jan 2021, after receiving the vaccine, the patient had a syncopal episode. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the event, syncopal episode, was considered unknown.; Reporter's Comments: This case concerns a male patient of unknown age. The medical history is not provided. The patient experienced a medically significant and unexpected event of Syncope occurred one day (same day) after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/17/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical History not provided),,,['Syncope'],1,MODERNA, 1026008,CT,47.0,F,"New sensitives to face cleansers; Anaphylactic shock; A spontaneous report was received from a consumer, concerning herself, a 47-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced anaphylactic shock and ""newsensitives to face cleansers"". The patient's medical history was not provided. Concomitant product use included face cleansers. On 08-Jan-2021, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 08-Jan-2021, approximately five minutes after receiving the vaccine, the patient experienced anaphylactic shock as evidenced by throat warm and tingling, arms was bright red and warm to touch, trouble breathing, felt like choking, and nausea. Hence, she was treated with ""epinephrine quite a few times along with steroids and ranitidine"". On 09-Jan-2021, the patient went to the hospital two more times for ""breathing issues"", however she was not admitted. On 10-Jan-2021, in the morning, the patient had ""passed out"" and was given another epinephrine injection as she went into anaphylaxis shock again. On-29 Jan-2021, the patient also reported her arm, legs and chest are ""bright red"" and ""burns"". The patient also experienced new sensitivities to the face cleansers she has used for over 12 years. Action taken with mRNA-1273 in response to the events were unknown. The events, anaphylactic shock, was considered newsensitives to face cleanser"" were considered not resolved.; Reporter's Comments: This case concerns a 47-year-old female patient, who experienced serious event of anaphylactic shock and non-serious event of sensitive skin. The event of anaphylactic shock occurred on the same day and re-occurred again approximately 2 days after first dose of mRNA-1273, lot # unknown. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Anaphylactic shock', 'Sensitive skin']",1,MODERNA,OT 1026009,,61.0,F,"nosebleeds got worse where she was filling up towels with blood; sore throat; cough; A solicited report was received from a 61-year-old female patient, who who received Moderna's COVID-19 vaccine (mRNA-1273) developed significant nosebleeds where she was filling up towels full of blood, sore throat and coughing during and after her Tyvaso session. The patient's medical history included Secondary Pulmonary Arterial Hypertension. Products known to have been used by the patient within two weeks prior to the event was Sildenafil Citrate. Additional suspected products included Treprostinil Sodium, Plavix, and Aspirin. On an unknown date, the patient received one of two planned doses of mRNA-1273 (Lot: unknown) for prophylaxis of COVID-19 infection. On an unknown date, after receiving the vaccine, the patient experienced worsening of nosebleeds filling up towels full of blood, sore throat and coughing. Treatment for the events, nosebleed, sore throat and cough was not reported. Action taken with second dose of mRNA-1273 in response to the events was not reported. The event, worsening of nosebleeds filling up towels full of blood was considered not resolved and outcome of the events, sore throat and cough was not reported.; Reporter's Comments: This case concerns a 61 year old female patient with medical history of Secondary Pulmonary Arterial Hypertension, who experienced a serious unexpected event of Epistaxis and NS events of oropharyngeal pain and cough. The events occurred on an unknown date after first dose of the study medication administration. A causal relationship cannot be excluded. Noting the subject's underlying medical condition and concomitant medication could remain a confounder.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,TREPROSTINIL SODIUM; PLAVIX; ASPIRIN [ACETYLSALICYLIC ACID]; SILDENAFIL CITRATE,,Medical History/Concurrent Conditions: Secondary pulmonary arterial hypertension,,,"['Cough', 'Epistaxis', 'Oropharyngeal pain']",1,MODERNA,OT 1026011,CA,60.0,M,"Bled Out 40% of blood from lower GI; Bloody diarrhea; Lightheaded; Sweating; Malaise; Fever; tachycardia; A spontaneous report was received from a pharmacist who is a 60-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bloody diarrhea, bled out 40 percent of blood from lower gastrointestinal tract, tachycardia, sweating, lightheaded, malaise and fever. The patient's medical history was not provided. No concomitant product use was reported. On 31 Dec2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection. On 14 Jan 2021, the patient reported 14 days after receiving the vaccine, he developed tachycardia with a heart rate of 120 and did not feel right. The patient stated was sweating and thought he was having a heart attack. On an unknown date, the patient saw his doctor who performed an electrocardiogram (EKG) � results not provided. The patient also stated he had blood pressure issues but did not provide any further information. On an unknown date, the patient reported he was hospitalized with bloody diarrhea. He stated he bled out 40 percent of blood from his lower gastrointestinal track. He reported he had malaise and fever as well. The patient reported he had to have surgery to stop the bleeding. Treatment for the event included surgery. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, bloody diarrhea, bled out 40 percent of blood from lower gastrointestinal track, tachycardia, sweating, lightheaded, malaise and fever, were considered unknown.; Reporter's Comments: This case concerns a 60 year old male patient, who experienced a serious event of gastrointestinal haemorrhage, associated with other non-serious events after receiving first dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Yes,Yes,,Not Reported,U,12/31/2020,01/14/2021,14.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Diarrhoea haemorrhagic', 'Dizziness', 'Electrocardiogram', 'Gastrointestinal haemorrhage', 'Heart rate', 'Hyperhidrosis', 'Malaise', 'Pyrexia', 'Tachycardia']",1,MODERNA,OT 1026012,CA,21.0,F,"Fainted; A spontaneous report was received from a 21-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainted (syncope). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received her first of two planned doses of mRNA-1273 (lot/batch number unknown) in the left arm in approximately January 2021 for prophylaxis of COVID-19 infection. In approximately January 2021 (a few days later after vaccination), the patient experienced fainted. Treatment information was not provided. The action taken with mRNA-in response to the event was unknown. The outcome of the event fainted was unknown.; Reporter's Comments: This case concerns a 21-year-old, female, patient, who experienced a serious unexpected event of syncope. The event occurred at unknown date, reported as few days later, after first dose of mRNA-1273, lot # unknown. Treatment information is not provided. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Syncope'],1,MODERNA,OT 1026014,CA,,F,"Hypertensive crisis; Flushing in face, it became red, and swollen; Flushing in face, it became red, and swollen; Flushing in face, it became red, and swollen; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a hypertensive crisis, flushing in face, it became red and swollen. The patient's medical history was not provided. No concomitant product use was reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On the unknown date, approximately half an hour after receiving the Moderna COVID-19 vaccine, the patient had facial flushing, it was red and swollen. The patient was taken to the emergency room for hypertensive crisis. Her blood pressure was 250/150 mmHg. She was in the emergency room for four hours until her blood pressure came down. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, hypertensive crisis, flushing in face, it became red and swollen, was unknown.; Reporter's Comments: This spontaneous report (which concerns a female patient who experienced hypertensive crisis and flushing in face and it became red and swollen. The events occurred half hour after the administration of mRNA-1273 vaccine (Lot number: 041L20A, expiration date: unknown). Based on the information provided which shows a temporal association, a causal association between the reported events and the administration of mRNA-1273 vaccine cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Blood pressure measurement', 'Erythema', 'Flushing', 'Hypertensive crisis', 'Swelling face']",1,MODERNA,OT 1026015,OR,,F,"Had headache that was similar to migraine; Feeling foggy; Diarrhea; Episode of nausea; Extreme fatigue; Muscle ache; Rash inside armpit; Anaphylactic reaction; Tingling in arm; Itching; Rapid heartbeat; Started feeling hot; Petechia eye; Tiny broken vessel on both ankles; A spontaneous report was received from a consumer who was also a female patient over the age of 55 but under 60 years of age who received Moderna's Covid-19 vaccine (mRNA-1273) and who experienced anaphylactic reaction, tingling in arm, itching, rapid heartbeat, started feeling hot, rash inside of armpit, petechia eye, tiny broken vessel on both ankles, headache similar to migraine, nausea, extreme fatigue, feeling foggy, muscle ache, and diarrhea. The patient's medical history was significant for anaphylactic reaction to cephalosporin antibiotics. No other medical history was provided by the patient. Concomitant product use was not provided by the patient. On 24 Jan 2021, prior to the onset of symptoms, at the County Health Department, the patient received the first of two planned doses of mRNA-1273 intramuscularly into her upper left arm. Because of her past medical history, the patient was observed for 30 minutes at the facility for any adverse reaction. When the observation period ended the patient went to her car and sometime later began having a delayed reaction. She reported experiencing the following symptoms: ""tingling in arm"", ""itching"", ""rapid heartbeat"", ""started feeling hot"", ""rash inside of armpit"", ""petechia eye"", and ""tiny broken vessel on both ankles"". The patient went to an Urgent Care Clinic, where she was treated with an injection of diphenhydramine and an oral prednisone. She was given a prescription for diphenhydramine, and prednisone. The patient was informed that she had an anaphylactic reaction to the vaccine. On 25 Jan 2021, the patient stated she had a ""headache similar to a migraine"", ""episode of nausea"", ""extreme fatigue"", ""feeling foggy"", ""muscle ache"", and ""diarrhea"". She was being followed up by an allergist. Action taken with mRBA-1273 in response to the events was not provided. The outcome of the events, anaphylactic reaction, tingling in arm, itching, rapid heartbeat, started feeling hot, rash inside of armpit, petechia eye, and tiny broken vessel on both ankles, and headache similar to a migraine, episode of nausea, extreme fatigue, feeling foggy, muscle ache, and diarrhea, was considered unknown.; Reporter's Comments: This case concerns a 55-60 year old female who had a serious unexpected anaphylactic reaction, with NS unexpected paranesthesia, pruritus, HR increased, feeling hot, rash, petechia, telangiectasia, migraine, feeling abnormal, diarrhea, and NS expected nausea, fatigue, myalgia. Event onset 1 day after first dose mRNA-1273. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/24/2021,01/24/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Anaphylactic reaction to drug (No other medical history provided),,,"['Anaphylactic reaction', 'Diarrhoea', 'Fatigue', 'Feeling abnormal', 'Feeling hot', 'Heart rate increased', 'Migraine', 'Myalgia', 'Nausea', 'Paraesthesia', 'Petechiae', 'Pruritus', 'Rash', 'Telangiectasia']",1,MODERNA,OT 1026016,KY,45.0,F,"possible case of cellulitis; arm feeling heavy; hot to touch; swelling; rash developed that was 3-4 inches diagonal that appear to spread to upper arm in couple of days; redness; shower with itchiness at the site of injection that was round in shape; thrust from antibiotics bactrim and Amo/Clav; on and off adverse event with feeling left ear on fire; A spontaneous report was received from a healthcare facility staff member concerning a 45-years-old, female patient who experienced possible case of cellulitis, on and off adverse event with feeling left ear on fire, hot to touch, redness, swelling, arm feeling heavy, thrust from antibiotics, rash developed that was 3-4 inches diagonal that appear to spread to upper arm in couple of days and shower with itchiness at the site of injection that was round in shape. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 06-Jan-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 012L20A] intramuscularly in the right upper arm for prophylaxis of COVID-19 infection. On 06 Jan 2021, the patient started experiencing on and off adverse event with ""feeling left ear on fire"". Eight days later the patient noticed itchiness at the site of the injection that was round in shape. Rash developed that was 3-4 inches diagonal that appeared to spread to upper arm. The injection site was hot to touch, redness, swelling and arm feeling heavy. On 13 Jan 2021 or 14 Jan 2021, the patient was recommended Bactrim (sulfamethoxazole, trimethoprim), amox/Clav (amoxicillin, clavulanic acid) and clotrimazole lozenges because the primary care physician (PCP) was believing she possible has a case of cellulitis. The patient went to the emergency room (ER) on 17 Jan 2021, in which an ultrasound was performed and did not suspect any blood clot or cellulitis. Upon discharge, the patient experienced thrust from antibiotics. Treatment for the event included Bactrim (sulfamethoxazole, trimethoprim), amox/clav (amoxicillin, clavulanic acid), clotrimazole lozenges and Benadryl (diphenhydramine hydrochloride). Patient informed that the symptoms are on-going where the swelling and redness comes and goes. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events possible case of cellulitis, on and off adverse event with feeling left ear on fire, hot to touch, arm feeling heavy, thrust from antibiotics, rash developed that was 3-4 inches diagonal that appear to spread to upper arm in couple of days and shower with itchiness at the site of injection that was round in shape was considered as not recovered and for redness and swelling outcome is considered as unknown.; Reporter's Comments: This case concerns a 45 year old female subject with a serious unexpected cellulitis, with NS unexpected burning sensation, feeling hot, limb discomfort, thrush, and NS expected Vaccination site events of erythema, swelling, pruritus, and rash. Event onset same day as first dose mRNA-1273. US without blood clot or cellulitis. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Burning sensation', 'Candida infection', 'Cellulitis', 'Feeling hot', 'Limb discomfort', 'Rash', 'Ultrasound scan', 'Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site swelling']",1,MODERNA,OT 1026018,NC,28.0,F,"Lightheadedness within 5 minutes; weakness of muscles; rapid heart rate; This is a spontaneous report from a contactable other HCP reporting for herself. A 28-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , intramuscular on 25Jan2021 09:00 at single dose for Covid-19 immunisation . The patient medical history and concomitant medicatons were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient experienced lightheadedness, weakness of muscles and rapid heart rate on 25Jan2021 09:15 with outcome of recovering. The patient was treated in Emergency Room with steroids and anxiety medications. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,PVT,,,,,,"['Dizziness', 'Heart rate', 'Heart rate increased', 'Muscular weakness']",1,PFIZER\BIONTECH,OT 1026019,TX,39.0,F,"I got a strange vision/hallucination; rapid and hard heartbeat; shortness of breath; nausea; headache; had nightmares all night; stiff, sore arm; stiff, sore arm; my arm has a bumpy, red mild rash at and around injection site; my arm has a bumpy, red mild rash at and around injection site; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318), via an unspecified route of administration on 26Jan2021 at 14:45 (at the age of 39 years) as a single dose in the right arm for COVID-19 vaccination. Medical history included fatty liver. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date. Concomitant medications were not reported. The patient reported that on 27Jan2021 at 12:30 AM, approximately ten hours after the vaccine, the patient experienced a rapid and hard heartbeat, shortness of breath, nausea and headache. These lasted for one and one half hours. As she lay down falling asleep she got a strange vision/hallucination (this had never happened to her before) of her eyes turning lightning blue and her body rising up in the bed. She stated that she does not take medications or drugs and does not have a history of mental illness. She could not shake the vision. She fell asleep and had nightmares all night and nightmares are rare for her. One day two she woke up fine just a stiff, sore arm. On day three her arm has a bumpy, red mild rash at and around injection site. The patient did not receive any treatment for the events. Lab data included a COVID SARS CoV-2 positive test on an unspecified date. The clinical outcomes of hallucination, heart rate increased, shortness of breath, nausea, headache, nightmares, pain in arm, limb stiffness and vaccination site rash were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/01/2021,,OTH,,,Medical History/Concurrent Conditions: COVID-19 (If covid prior vaccination: Yes); Fatty liver,,,"['Dyspnoea', 'Hallucination', 'Headache', 'Heart rate increased', 'Musculoskeletal stiffness', 'Nausea', 'Nightmare', 'Pain in extremity', 'SARS-CoV-2 test', 'Vaccination site erythema', 'Vaccination site rash']",1,PFIZER\BIONTECH, 1026020,FL,53.0,M,"looked like pancreatitis; developed increased LFTs; This is a spontaneous report from a contactable physician (patient). A 53-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, saoluion ), via an unspecified route of administration on the left arm on 07Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical history included hyperlipidemia and benign prostatic hyperplasia (BPH). The patient has no known drug allergy (NKDA) and no known food allergy (NKFA). Concomitant medications included duloxetine hydrochloride (CYMBALTA), acetylsalicylic acid (ASPIRIN 81), diphenhydramine hydrochloride (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]), multivitamins [vitamins NOS] (MULTIVITAMINS [VITAMINS NOS]). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number: eh9899, expiration date: unknown), at the age of 53 years old, on the left arm on 17Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed increased liver function tests (LFTs) that looked like pancreatitis on 08Jan2021 at 12:00. Treatment received for the adverse event include addition of PPI. The events resolved with sequel. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,CYMBALTA; ASPIRIN 81; BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]; MULTIVITAMINS [VITAMINS NOS],,Medical History/Concurrent Conditions: BPH; Hyperlipidemia,,,"['Liver function test', 'Liver function test increased', 'Pancreatitis']",2,PFIZER\BIONTECH, 1026021,MD,,M,"a male patient received the pneumonia shot 12 days after the first dose of the vaccine; he had died; This is a spontaneous report from a contactable consumer or other non hcp. A 76 years old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID 19 immunisation and received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration on an unspecified date 12 days after bnt162b2 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities. Information on lot and batch number has been requested. Follow-up: (08Feb2021): Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: a male patient received the pneumonia shot 12 days after the first dose of the vaccine; he had died",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Death', 'Inappropriate schedule of product administration']",UNK,UNKNOWN MANUFACTURER, 1026022,,67.0,F,"she felt so tired; her breathing was heavy and felt tight; This is a spontaneous report from a contactable nurse. A 67-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EL9262), at age 67 years, injection into the left upper arm/deltoid, first dose on 27Jan2021 14:00 at single dose, for COVID-19 vaccination. Ongoing medical history included diabetes diagnosed more than 10 years ago and high cholesterol diagnosed around 10 years ago, maybe longer. The patient's concomitant medications were unspecified maintenance medications because she is diabetic and has high cholesterol. She said that she has been taking these medications for a long time though already. Patient was a retired registered nurse that was calling about the COVID-19 vaccine and reported that she had the first dose injection on 27Jan2021 at 14:00 and 2 hours after she got home, she felt so tired that she did not feel like moving and her breathing was heavy and felt tight. Patient said that her breathing feeling heavy and tight did not last too long, maybe an hour then went away. Her tiredness, felt so tired lasted through the day and whole night and she was fine and completely recovered after waking up in the morning. For breathing feeling heavy and tight: She clarified that it lasted from like 14:00-17:00 yesterday 27Jan2021. Patient wanted to know with the symptoms she had is it contraindicated to get the second dose? She was reading the information about the injection and seemed like the symptoms are part of it. The outcome of the events was recovered, for felt so tired was on 28Jan2021 and for breathing was heavy and felt tight was on 27Jan2021. Case was reported as serious with other medically important condition as seriousness criteria. The reporter assessed the events she felt so tired and her breathing was heavy and felt tight as related to the suspect drug COVID-19 Vaccine. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,UNK,,Diabetes; High cholesterol,,,,"['Dyspnoea', 'Fatigue']",1,PFIZER\BIONTECH,OT 1026023,MO,82.0,M,"Was in the hospital for his heart condition; he had something around his chest area, some kind of pressure on his chest area; Chills; He ran a temperature of 100.4/running a temperature of 100.8; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9261), via an unspecified route of administration on the left arm on 27Jan2021, at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter (patient's wife) stated that both (patient and patient's wife) had the Vaccine shot on Wednesday, 27Jan2021. After that she was okay but he was not, he had something around his chest area, some kind of pressure on his chest area on Thursday (28Jan2021), he was in the hospital for his heart condition. Patient was done with stress test was good, had another test (unspecified) and he was okay. He had some temperature on Thursday while he was in hospital, next day on Friday (29Jan2021) he was relieved, then he was doing fine. He came home on 29Jan2021, and he started getting aspirin (given in hospital) and took cardiac medicine (unspecified). Everything was okay until few hours later, around 7 o'clock he started getting chills with running a temperature of 100.8 and then by 8 o'clock he ran a temperature of 100.4 (on 29Jan2021). Then call to nurse and the doctor, nurse said to give him the Extra Tylenol which was given at 9 o'clock and then patient's wife took his temperature again last at 11 o'clock, it was 99.55. Then this morning (30Jan2021) at 8 am it was 99.5 and patient had Tylenol and then also at 11 o'clock this morning it was 98.2, this afternoon at 2:45 it was back up to 99. At then at 3:53 it went up to 100.2, so at that point at 4 o'clock, given him Tylenol. He had some chills with it (Clarification unknown), chills were going back and forth. Seriousness of the events heart condition and chest pressure was reported as hospitalization. Outcome of the events was unknown.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/27/2021,01/28/2021,1.0,UNK,,,,,,"['Body temperature', 'Cardiac disorder', 'Cardiac stress test', 'Chest discomfort', 'Chills', 'Investigation', 'Pyrexia']",1,PFIZER\BIONTECH, 1026024,MO,32.0,F,"passed out and almost broke her arm; started salivating really bad/it's lot of drool; Heart rate started pounding; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261, expiration date May2021), via an unspecified route of administration on 26Jan2021 at single dose for COVID-19 immunisation. Medical history included: Allergy. Concomitant medication included drospirenone, ethinylestradiol (YASMIN) for Birth control, chlorphenamine maleate (PIRITON) for Allergy. The patient was perfectly fine up until about the 3 hours after the vaccine, she started salivating really bad, she was not throwing up or nauseas or anything, it's just that it's lot of drool, like she even had just go over sink as just salivating so much it was weird, and her heart rate started pounding and she passed out and almost broke her arm, so and then she kind of like blacked out and don't remember anything for rest of the evening. The events onset date was on 26Jan2021 08:30. No treatment was received. The outcome of events was recovered in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,YASMIN; PIRITON,,Medical History/Concurrent Conditions: Allergy,,,"['Heart rate', 'Heart rate increased', 'Loss of consciousness', 'Salivary hypersecretion']",1,PFIZER\BIONTECH, 1026025,FL,39.0,F,"cold extremities; fever; chills; fatigue; rheumatoid arthritis; This is a spontaneous report from a non-contactable physician. A 39-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. Historical Vaccine included received first dose of BNT162B2 intramuscular at the age of 39-year-old on 16Dec2020 at single dose for COVID-19 immunization and did fine. The patient did fine after first dose, after second dose had 36 hours of fever and chills. Covid test negative. Several weeks later she developed fatigue and cold extremities. She was found to have elevated CCP (Cyclic Citrullinated Peptide) antibodies, dx (diagnosis) rheumatoid arthritis. All events occurred on 04Jan2021. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment received for the events included medication for pain, specialist referral. There was no other vaccine received in four weeks. The patient was no pregnant. The patient had no COVID prior vaccination. Covid test (Nasal Swab) post vaccination was Negative. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the time association and drug's safety profile, the events fever, chills, fatigue, and cold extremities are possibly related to suspect vaccine BNT162B2 administration. The event rheumatoid arthritis is more likely underlying/intercurrent condition, unrelated to suspect vaccine BNT162B2 injection given the product's safety profile and the pathophysiology of rheumatoid arthritis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,,01/04/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Anti-cyclic citrullinated peptide antibody', 'Chills', 'Fatigue', 'Peripheral coldness', 'Pyrexia', 'Rheumatoid arthritis', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1026045,NE,75.0,F,"On 2/7/21 resident complainted of not feeling well, nausea, vomiting and weakness sent to ER passed away.",Yes,02/08/2021,Not Reported,Yes,2.0,Not Reported,N,02/01/2021,02/07/2021,6.0,SEN,,COPD,"COPD, history of stroke",,"Sulfa, Hydroxizine,","['Asthenia', 'Death', 'Malaise', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,SC 1026074,CO,84.0,F,"left side facial drooping, unable to close left eye, mouth droop",Not Reported,,Not Reported,Not Reported,,Yes,N,01/11/2021,01/13/2021,2.0,PUB,"prednisone, acyclovir",none,"dementia, gastroesophageal reflux, hypertension, heart murmur",,"protonix, demerol, fosomax, and sulfa","['Eyelid function disorder', 'Facial paralysis']",1,MODERNA, 1026089,KY,70.0,M,Patient found to have platelet count of 7 on routine labs checked 2 days after vaccine. Confirmed on repeat testing.,Not Reported,,Not Reported,Yes,4.0,Not Reported,U,02/03/2021,02/05/2021,2.0,PUB,"doxycycline, ibuprofen, spironolactone, Ranexa, Paxil, omeprazole, metoprolol, Glucophage, Altoprev, glyburide, gabapentin, Lasix, Plavix, aspirin, Norvasc",none,"diabetes mellitus type 2, CAD, HTN, NASH, h/o MRSA vertebral osteomyelitis",,isosorbide nitrate,"['Biopsy bone marrow', 'Immunoglobulin therapy', 'Platelet count decreased', 'Platelet transfusion']",1,MODERNA,IM 1026094,AZ,70.0,F,"Patient tested positive for COVID-19 on 2/4/21, she had symptoms of cough and sore throat on 2/2/21. She was admitted to hospital on 2/12/21 COVID-19 pneumonia and hypoxic respiratory failure.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/28/2021,02/02/2021,5.0,PVT,,,,,,"['COVID-19', 'COVID-19 pneumonia', 'Cough', 'Oropharyngeal pain', 'Respiratory failure', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1026095,,90.0,M,DEATH 2/12/21,Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,01/16/2021,02/12/2021,27.0,SEN,,,,,,['Death'],2,PFIZER\BIONTECH,IM 1026117,CA,75.0,F,Sudden Loss of hearing right ear,Not Reported,,Not Reported,Not Reported,,Yes,N,01/22/2021,02/02/2021,11.0,PUB,None,None,None,,None,"['Audiogram', 'Sudden hearing loss']",1,PFIZER\BIONTECH,SYR 1026131,,56.0,F,Employee was diagnosed with Bell's Palsy 16 days after receiving 2nd dose of Moderna COVID 19 vaccination,Not Reported,,Not Reported,Yes,,Not Reported,,01/20/2021,02/05/2021,16.0,UNK,,,,,,['Facial paralysis'],2,MODERNA,IM 1026132,FL,35.0,M,Bilateral unprovoked pulmonary embolisms. Started anticoagulation therapy,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/14/2021,01/31/2021,17.0,UNK,None,None,None,,None,"['Computerised tomogram thorax', 'Pulmonary embolism', 'Scan with contrast']",UNK,MODERNA, 1026141,,82.0,M,death 2/12/21,Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,01/16/2021,02/12/2021,27.0,SEN,,,,,,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1026163,AZ,84.0,F,"Received vaccine 7:30 PM Monday, began feeling tinging in lower lip Tuesday, did not notice any symptoms Wednesday, Thursday 11:00 AM noticed drooping left side of face, couldn't smile on left side, eye drooping, difficult to close left eye. Transported to ER by ambulance at 11:30 AM. Diagnosed with Bell's Palsy. Released from ER to home.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/08/2021,02/09/2021,1.0,PUB,"Xarelto, Digoxin, Donepezil, Vitamin D3,Carvedilol, Synthroid,",none,AFib,,Sulpha meds,"['Blood test normal', 'Computerised tomogram head', 'Computerised tomogram head normal', 'Eye movement disorder', 'Eyelid ptosis', 'Facial paralysis', 'Paraesthesia oral']",2,PFIZER\BIONTECH,IM 1026170,OH,71.0,M,"Shortly after first Moderna injection, while driving home, developed shortness of breath and chest pain, was diagnosed with an MI per the hospital, abnormal EKG and enzymes, currently on ventilator and awaiting surgery for coronary bypass surgery. Hospitalized at the point of this input.",Not Reported,,Yes,Yes,,Not Reported,N,02/08/2021,02/08/2021,0.0,PVT,"Allopurinol, ezetimibe, finasteride, gabapentin, glipizide, liraglutide, losartan, metformin, metoprolol, oxybutynin, tamsulosin",,"CAD, peripheral neuropathy, arthritis, diabetes, HTN, spinal stenosis",,multiple statins,"['Chest pain', 'Dyspnoea', 'Electrocardiogram abnormal', 'Enzyme abnormality', 'Mechanical ventilation', 'Myocardial infarction', 'Myocardial necrosis marker']",1,MODERNA,IM 1026171,,82.0,M,"WOKE UP THIS MORNING NOT FEELING WELL, MANAGED TO SLOWLY WALK INTO KITCHEN, FELT PROFOUNDLY WEAK, BECAME DIAPHORETIC, UNABLE TO SPEAK, SYMPTOMS LASTED FOR 10-15 MINUTES AND GRADUALLY RESOLVED OVER COURSE OF 1 HOUR.",Not Reported,,Not Reported,Yes,,Yes,Y,02/11/2021,02/12/2021,1.0,PVT,"XARELTO, LISINOPRIL/HCTZ , SIMVASTATIN, OMPERAZOLE",NO OTHER CURRENT IN PAST MONTH,"HYPERTENSION, ATRIAL FIBRILLATION, HISTORY OF STROKE IN LATE DEC 2020",,NKDA,"['Aphasia', 'Asthenia', 'Cardiovascular evaluation', 'Cerebrovascular accident', 'Computerised tomogram head', 'Computerised tomogram head abnormal', 'Hyperhidrosis', 'Malaise']",1,MODERNA,IM 1026233,ND,89.0,M,patient developed autoimmune thrombocytopenia,Yes,02/11/2021,Not Reported,Yes,9.0,Not Reported,N,01/18/2021,02/02/2021,15.0,PVT,Plaquenil 200 mg bid/ mirtazapine 30 mg qhs / amlodipine 2.5 mg daily / atorvastatin 80 mg daily / Lasix 40 mg daily / imdur 30 mg qam/ losartan 100 mg daily / Plavix 75 mg daily/ NTG 0.4mg prn/ levothyroxine 150 mcg daily,none,"hypothyroidism,/ acute on chronic diastolic heart failure / polymyalgia rheumatica / hx of cva / hx of CABG/ gerd / bph/ polyarthritis",,hayfever / Darvocet / norco,"['Immune thrombocytopenia', 'Platelet count decreased']",1,MODERNA,IM 1026270,WI,90.0,F,"At 10:33 am Patient pushed her pendant for staff, staff arrived to her apartment and Patient was found unresponsive in her bathroom. Patient received her second COVID-19 Pfizer vaccine about 75 minuets prior to this, she had no adverse reaction's within the first hour of receiving the second dose. CPR was started until paramedics arrived, they took over and tried to resuscitate. Patient was pronounced dead at 11:33 am at scene.",Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,SEN,Albeterol Inh Soln 0.083 % Calcium 600mg + D 400 IU One Daily Woman 50 + tablet Cetirizine HCL 10 mg Tablet Digozin 0.125 mg Tablet Levothyroxine 100 mcg tablet Metoprolol Tartrate 50 mg Tablet Esomeprazole Mag. Dr 40 mg Capsule Nitroglyc,,"primary hypertension Mitral Valve regurgitation COPD Osteoporosis Kyphoscoliosis deformity of spine Rheumatoid factor positive GERD history of cellulitis of leg history of C-diff post ATB therapy Monoclonal gammopathy Iron deficiency anemia, unspecified Hypothyroidism, unspecified Hyperlipidemia, unspecified Coronary atherosclerosis due to lipid rich plaque Nonrheumatic tricuspid valve disorder, unspecified Chronic atrial fibrillation Allergic rhinitis, unspecified Barrett's esophagus without dysplasia Other specified urinary incontinence",,"Ceftin, Cefuroxine, Sulfa","['Death', 'Resuscitation', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 1026333,AZ,76.0,M,Chest pain elevated Troponin 112 T EKG Cardio Cath No sign of damage Diagnosis Cardiovascular Spasms,Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/24/2021,01/24/2021,0.0,OTH,,,,,Percogesic,"['Blood test', 'Catheterisation cardiac normal', 'Chest pain', 'Computerised tomogram', 'Echocardiogram normal', 'Electrocardiogram normal', 'Troponin increased']",1,PFIZER\BIONTECH,IM 1026362,PA,32.0,M,Patient stated he had a migraine after the vaccine. We were advised of a change in appetite on Thursday February 4th. Patient died on February 6th.,Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,01/01/2021,02/04/2021,34.0,SEN,,,Duchenne muscular dystrophy,,,"['Appetite disorder', 'Autopsy', 'Death', 'Migraine']",UNK,PFIZER\BIONTECH, 1026379,OH,58.0,M,patient 6 hours post vaccination,Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/09/2021,0.0,PVT,OXYMETAZOLINE HCL 0.05% NASAL SPRAY DISCONTINUED 30 02/09/2021 02/09/2021 02/09/2021 1 USE 1 SPRAY NASAL TWICE A DAY MAX OF 3 DAYS OF USE** DOCUSATE NA 50MG/SENNOSIDES 8.6MG TAB DISCONTINUED 60 02/09/2021 01/20/2021 01/21/2021,HTN-Iron def-h/o PE-chronic renal failure,HTN-Iron def-h/o PE-chronic renal failure,,,['Death'],2,MODERNA, 1026396,MO,90.0,F,Patient experienced loss of taste and lack of appetite. Passed away on 1/23/21.,Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/15/2021,1.0,PHM,Unknown,Unknown,Unknown,,Unknown,"['Ageusia', 'Death', 'Decreased appetite']",1,MODERNA,IM 1026443,MS,76.0,F,Received first 1/15/2021 with no adverse reaction. Received 2nd dose 2/9 @ 0846 with no adverse reaction or report of feeling ill. Traveled to store and arrived approx. 2 hours after receiving vaccine. Daughter stated patient felt well and had to go to the restroom to have BM. Collapsed in bathroom. Transported by ambulance to Hospital @ 1439 in cardiac arrest. Was in PEA and went in v fib back to PEA. Resuscitation efforts initiated and patient expired with time noted at hospital records at 15:11.,Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/09/2021,0.0,PUB,"Amalodopine, Treesiba, Metoprolol, Prevastatin, Telmisarta-HTZ",Unknown,"High Blood Pressure, Adult Onset Diabetes Mellitus",,None,"['Cardiac arrest', 'Death', 'Pulseless electrical activity', 'Resuscitation', 'Syncope', 'Ventricular fibrillation']",2,MODERNA,IM 1026451,IN,90.0,F,Resident expired 2/2/2021 one day after the vaccine,Yes,02/02/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/02/2021,1.0,SEN,,,,,,['Death'],2,MODERNA,SYR 1026473,MA,83.0,M,"Initially presented with weakness/fatigue. He was found to have abnormal liver enzymes with AST/ALT in the 900s, T bili of 10, creatinine of 1.7. CK was elevated >13K. Patient overall worsening and anuric requiring possible hemodialysis for worsening renal function. Overall picture most suggestive of rhabdomyolysis. Unclear etiolgy but can't rule out a vaccine reaction.",Not Reported,,Not Reported,Yes,,Yes,N,02/05/2021,02/05/2021,0.0,PVT,"ASA 81, atorvastatin, Vitmain D3, Pepcid, lantus, lispro, imdur, synthroid, troprol-xl, aldactone, multivitamin, flomax, tramadol",,"Nodular Regenerative Hyperplasia complicated by portal HTN, HFrEF, T2DM",,"Gabapentin, lisinopril","['Alanine aminotransferase increased', 'Anuria', 'Aspartate aminotransferase increased', 'Asthenia', 'Bilirubin urine present', 'Blood alkaline phosphatase increased', 'Blood bilirubin increased', 'Blood creatine phosphokinase increased', 'Blood creatinine increased', 'Blood urine present', 'Fatigue', 'Hepatitis B test negative', 'Hepatitis viral test negative', 'International normalised ratio increased', 'Protein urine present', 'Renal impairment', 'Rhabdomyolysis']",1,PFIZER\BIONTECH,SYR 1026477,CA,70.0,M,"he developed shortness of breath and weakness within 24 hours of vaccination. over next 72 hours, developed progressive symmetric proximal muscle weakness with labs/imaging c/w myositis. also had biochemical evidence of cell lysis (elevated uric acid, high K, low Ca, high phos). He received steroids 2/11 with near complete recovery in function by 2/12, but biochemical changes were already improving by time of steroid dosing.",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,02/05/2021,02/06/2021,1.0,PVT,"calcium carbonate (TUMS) 500 mg (200 mg elemental) chewable tablet Chew 1 tablet (500 mg total) by mouth daily cholecalciferol, vitamin D3, 1000 UNITS tablet Take 1 tablet (1,000 Units total) by mouth daily gabapentin (NEURONTIN) 300 mg cap","metastatic prostate cancer - received pembrolizumab last 12/2020, cabazi/carbo 1/13/21","metastatic prostate cancer, CKD, remote history of MALT lymphoma with no evidence of active disease",,NKDA,"['Asthenia', 'Blood calcium decreased', 'Blood creatine phosphokinase increased', 'Blood phosphorus increased', 'Blood potassium increased', 'Blood uric acid increased', 'Dyspnoea', 'Fasciitis', 'Laboratory test abnormal', 'Magnetic resonance imaging abnormal', 'Muscular weakness', 'Myositis', 'Oedema']",1,PFIZER\BIONTECH,IM 1026492,MA,82.0,F,The individual received the vaccine around 12:00pm on 02/11/21. Around 9pm the individual went to lay down on the couch at home and started to have difficulty breathing. Within 30 minutes the individual became week and unresponsive. She was transported to the hospital where she was pronounced deceased at 11:44 pm on 02/11/21.,Yes,02/11/2021,Yes,Yes,,Not Reported,N,02/11/2021,02/11/2021,0.0,PHM,,,,,,"['Asthenia', 'Death', 'Dyspnoea', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 1026499,WI,75.0,F,"Resident reviewed for incident. Resident received the second dose of the Moderna Covid-19 vaccine lot# 016M20A Exp 5/2/2021 on 2/5/2021 from clinic through pharmacy. Resident had her temp/O2 taken on AM shift and was 98.6/93%, beginning PM shift 98.4/95%. A few hours later noted that resident to have chills and was shaking RN assessment completed and vitals taken resident noted to have temp of 102.2, oxygen 95%, pulse 110. Resident alert and oriented at that time and talking to staff. Reported findings to APNP with order to send to ER. 911 called, residents brother updated. Upon EMT arrival RN went down to residents room with EMT and resident had an emesis as resident was getting cleaned up resident went unresponsive. Pulse noted to still be present at that time, resident did briefly respond to sternal rub and then went unresponsive again. Resident full code and EMT transferred to gurney and said that if they lost a pulse in route that they would transfer to hospital B instead of hospital A being the closest facility. RN called brother and gave update. Facility notified from Hospital that resident had passed away.",Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,PHM,"Lactulose, Lasix, Megestrol Acetate, Metoprolol Tartrate, Spironolactone, Lasix, Vitamin B12, Rifaximin, Milk Thistle, Tramadol","Enterococcus UTI, acute on chronic systolic and diastolic heart failure",",chronic kidney disease stage 3, cirrhosis, HTN, hypomagnesemia, hypothyroidism, neurocognitive disorder, hx of hepatic encephalopathy",,"Carvedilol, Tizanidine, Augmentin, ACE inhibitors, Bees","['Body temperature increased', 'Cardio-respiratory arrest', 'Chills', 'Death', 'Pulse absent', 'Tremor', 'Unresponsive to stimuli', 'Vomiting']",2,MODERNA,IM 1026534,MO,97.0,M,"resident had a stroke, sent to the hospital and died 4 days later",Yes,02/09/2021,Not Reported,Yes,4.0,Not Reported,N,02/03/2021,02/05/2021,2.0,SEN,"senna, pantoprazole, vit D2, fluoxetine, folic acid, melatonin, metoprolol",,", HTN, CKD, Alzheimer's",,ciprodex,"['Cerebrovascular accident', 'Death']",2,MODERNA,IM 1026558,CA,91.0,F,Stomach abdominal pain starting approx 24 hours after vaccination,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/19/2021,01/20/2021,1.0,OTH,varies,,"GI issues, heart failure, high blood pressure, hypo thyroid",,"Penicillin family, medical adhesives",['Abdominal pain upper'],1,MODERNA,SYR 1026581,WA,71.0,M,He had sudden death on Feb 4th. Unclear if this could be related to vaccination but since it was close in timing report has been filed. No known immediate reaction to vaccination.,Yes,02/04/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,02/04/2021,20.0,UNK,"Spironolactone, amlodipine, tamsulosin, losartan, pantoprazole, tadalafil, propranolol",He had sudden death on Feb 4th. Unclear if this could be related to vaccination but since it was close in timing report has been filed.,"Hyperparathyroidism s/p surgical correction in 2020, MGUS, Idiopathic peripheral neuropathy, gout, OSA",tetanus toxoid,"Erythromycin, PCN, Hmg-coa reductase inhibitors, nifedipine, tetanus toxoids, tetracyclines",['Sudden death'],UNK,MODERNA,IM 1026613,CO,70.0,M,"None of my health care providers have been able to explain the cause of my sudden loss of vision in my left eye at approx. 10:15 p.m. on 7 Feb 2021. At approx. 3:00 a.m. on 8 Feb I called my ophthalmologist's answering service and my ophthalmologist called me back shortly thereafter. She told me I should go to the ER which I did at approx. 4:00 a.m. where blood tests were done, an ultrasound of my left eye, CT scan of my head, and MRI of my head were performed all with negative results. When my vision was tested at the ER using the standard wall chart, I was unable to see the largest letter on the chart with my left eye. I saw my ophthalmologist at approx. 1:40 p.m. the same day after my 6 1/2 hour ER visit. I was diagnosed with Central Retinal Vein Occlusion. Both of my eyes were dilated and photos were taken of each eye. I was given an injection of Avastin in my left eye. As of today, 12 Feb 2021, I am still functionally blind in my left eye. I can see general large objects but am unable to see details or read written words either near or far. Prior to approx. 10:15 p.m. on 7 Feb, my vision was as it had been for several years prior with little if any degradation. I typically have an annual eye exam by my ophthalmologist but due to Covid-19 my last eye exam was 9 Dec 2019 at which time there was nothing to suggest that I would have such loss of sight in either of my eyes. I am a healthy person who takes no or very little medication when prescribed. I have never been hospitalized (other than this ER visit) or diagnosed with any significant medical condition. In late Dec 2020 following routine blood tests, I had a teleconference ""physical"" with my PCP at which time I was declared to be healthy. Upon leaving the ER at approx. 10:30 a.m. on 8 Feb my ""end of visit vitals"" were recorded as blood pressure 110/63, BMI 20.92, weight 150 lbs., height 5'11"", temperature 97.6 F, pulse 67, respiration 16, and oxygen saturation 95%. Late last year I had my usual flu vaccination without any side effects. After almost 2 weeks, I do still have a bruise at the Pfizer vaccine injection site on my left arm and I experienced mild muscle soreness the evening after my vaccination and the following morning. Normally I have no adverse reaction to vaccinations.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/30/2021,02/07/2021,8.0,OTH,"no prescriptions or over the counter medications, mature multivitamin, 1,000 mg vitamin C, Super B-complex vitamin, 50 mcg vitamin D3, 1,000 mg wild Alaskan salmon oil softgel",none,none,,none,"['Angiogram retina', 'Blindness unilateral', 'C-reactive protein', 'Computerised tomogram head normal', 'Differential white blood cell count normal', 'Full blood count', 'Injection site bruising', 'International normalised ratio', 'Lipids', 'Magnetic resonance imaging brain normal', 'Metabolic function test normal', 'Myalgia', 'Ophthalmological examination abnormal', 'Prothrombin time normal', 'Red blood cell sedimentation rate normal', 'Retinal vein occlusion', 'Sudden visual loss', 'Ultrasound eye normal']",1,PFIZER\BIONTECH,IM 1026617,NJ,52.0,M,"*Please note it is not known if event was related to vaccine* On 2/10/2021, at approximately 5:30 AM, patient began to experience dizziness and shortness of breath. Per witnesses, he then began to have seizure activity followed by cardiac arrest. He was treated with CPR and 1 shock from the AED, which resulted in spontaneous return of circulation. He was awake and confused after return of pulse and sent to Hospital Emergency Room. This event occurred 19 days post first vaccine. He was scheduled to get his second dose on 2/12/2021, but did not receive it due to event.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/22/2021,02/12/2021,21.0,WRK,"Prescriptions: None Over-the-counter: Claritan non-drowsy Supplements: Korean Red Ginsing Tonic, 1 Tsp per day; Apple Cider Vinegar gummies, 400 mg per day; Centrum Silver multi vitamin; Emergen-C 1000 mg Vit C; Glucosamine supplement; Pr",None,None,,None,"['Cardiac arrest', 'Catheterisation cardiac', 'Confusional state', 'Dizziness', 'Dyspnoea', 'Echocardiogram normal', 'Magnetic resonance imaging heart', 'Magnetic resonance imaging normal', 'Resuscitation', 'Seizure like phenomena']",1,PFIZER\BIONTECH,IM 1026649,NY,61.0,F,"2 days post-vaccination developed rash, muscle aches, nausea, diarrhea, vomiting and fever. 10 days post-vaccination admitted to hospital with acute kidney injury and hypotension. Released on oral steroids for presumed hypersensitivity reaction. Admitted second time 36 days post-vaccination rapid worsening of rash, nausea, vomiting, diarrhea, fever and hypotension. Discharged to community on oral steroids",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,12/26/2020,12/31/2020,5.0,PVT,Amlodipine Besylate 5 MG TAB 5 MG ORAL DAILY Celecoxib 200 MG CAP 200 MG ORAL BID PRN PRN PAIN Hydrochlorothiazide 25 MG TAB 25 MG ORAL DAILY Nebivolol Hcl (Bystolic 20 MG) 20 MG TAB 20 MG ORAL DAILY Omeprazole 20 MG CAP 20 MG ORA,none,Hypertension Anxiety Thyroid nodule Cesarean section x2 Spinal fusion Carpal tunnel surgery,,"NKA-no drug, latex, or food allergies","['Acute kidney injury', 'Diarrhoea', 'Hypotension', 'Myalgia', 'Nausea', 'Pyrexia', 'Rash', 'Vomiting']",1,MODERNA,IM 1026665,SC,71.0,F,Patient tested positive for COVID six days after receiving her first COVID-19 vaccination. Her symptoms began one day earlier on 1/20/21. She went to the hospital on 1/23/21 but was sent home. She was later taken back to the hospital and admitted to ICU on 1/25/21.,Not Reported,,Yes,Yes,19.0,Not Reported,N,01/15/2021,01/20/2021,5.0,PHM,,,,,,"['COVID-19', 'Intensive care', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1026671,TN,95.0,F,"The vaccine was administered at the patient's residence in an assisted living facility. The morning following the vaccination staff report that she was very agitated and stated she did not feel well. They called an ambulance and she was transported to a local ER, staff report that it was not at the hospital that the patient is usually seen by when when she has issues and they were concerned that the facility did not have her medical history to treat her properly. The patient's grandson reported back to the assisted living director that the patient was diagnosed with asymptomatic pneumonia, was transferred to the ICU and passed away in the night.",Yes,01/08/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PUB,unknown,none reported,unknown,,none,"['Agitation', 'Death', 'Intensive care', 'Malaise', 'Pneumonia']",1,UNKNOWN MANUFACTURER,IM 1026699,OH,95.0,M,"Had a stroke 3 days after round one of Covid vaccine and subsequently died the next week due to complications of stroke. Upon admission to hospital, was in afib.",Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/23/2021,3.0,UNK,,,,,,"['Atrial fibrillation', 'Cerebrovascular accident', 'Death']",1,PFIZER\BIONTECH,IM 1026728,TX,78.0,M,Red Bumps like chicken pox on face chest back neck & shoulders,Not Reported,,Not Reported,Yes,7.0,Not Reported,N,01/07/2021,01/15/2021,8.0,PHM,Allopurinol 100mg daily aspirin 81mg folic acid l mg twice Hydroxychloroquine oral 200mg twice daily Irbesartan 300mg daily otrexup 15mgl0.4 mLAtin inject in skin once a week Held Off 2 weeks before shot KEPPRA 500 mg twice daily,none,Rheumatoid Arthritis Had stent put in High Blood Pressure controlled by medicine Had melanoma in check which was cut out 6 years ago and cancer free since Has had seizures,,none,"['Rash erythematous', 'Rash vesicular']",UNK,MODERNA, 1026752,OH,77.0,F,"Developed vomiting, seizure and cardiac arrest, V Fib",Yes,02/08/2021,Not Reported,Yes,,Not Reported,N,02/03/2021,02/06/2021,3.0,OTH,Plavix Furosemide Amiodarone Humulin Lantus Levothyroxine NTG SL Pepsid Spironolactone Alprazolome Isosorbide Trazadone Nystatin topical Hydroxyuria Sertraline,,Heart Disease Hx of Triple Bypass surgery Atrial Fib CAD Diabetes GERD Hyperlipidemia HTN Hypothyroid Idiopathic Small Intestine Ulcers PAD Polycythemia,,Ace Inhibitor Allergy Morphine- Adverse Rxn,"['Cardiac arrest', 'Seizure', 'Ventricular fibrillation', 'Vomiting']",1,MODERNA,IM 1026768,NY,65.0,M,Bruising and bleeding on his hands and right medial thigh.,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/08/2021,02/10/2021,2.0,SEN,"Taking Lasix 20 mg tablet, Sig: 1 tab(s) orally once a day Start Date: 09/01/2020 Refill protein powder - dissolve in water, Sig: 2 scoop po 4x day Taking tamsulosin 0.4 mg capsule, Sig: 1 cap(s) orally once a day Refill lisinopril 2.","Chronic acquired lymphedema I87.2 Chronic venous stasis dermatitis of both lower extremities I83.029 Venous stasis ulcer, left D68.59 Primary hypercoagulable state E46 Protein deficiency G80.8 Monoplegic infantile cerebral palsy F89 Disability, developmental N02.8 Recurrent and persistent hematuria with other morphologic changes N04.9 IgA nephropathy with nephrotic syndrome N18.9 CKD (chronic kidney disease) E88.09 Hypoalbuminemia I10 Essential hypertension E55.9 Vitamin D deficiency I73.9 Peripheral vascular disease, unspecified L97.311 Ulcer of ankle, right, limited to breakdown of skin I11.9 Hypertensive heart disease without heart failure L97.921 Skin ulcer of left lower leg, limited to breakdown of skin Q61.3 Polycystic kidney disease Q44.6 Polycystic liver disease, congenital D68.59 Hypercoagulable state L97.321 Chronic ulcer of ankle, left, limited to breakdown of skin Z79.01 Long term (current) use of anticoagulants E78.2 Mixed hyperlipidemia I89.0 Lymphedema, not elsewhere classified N40.0 BPH (benign prostatic hyperplasia) Z79.01 Long term current use of anticoagulant therapy",See Above,,N.K.D.A,"['Contusion', 'Haemorrhage', 'International normalised ratio increased', 'Platelet count decreased']",UNK,PFIZER\BIONTECH,IM 1026783,MS,33.0,M,"I noticed a headache in the very top of my head within an hour of getting the vaccine. I thought it was normal because everyone I know said they got a headache from it. Over the next few hours, the pain moved down the back of my neck and became a burning sensation at the bottom of my skull. The pain was not excruciating but was constant. I thought it would eventually go away. I'm a pilot and fly for a living. Two days after receiving the vaccine I flew my plane and immediately noticed something was wrong with me. I was having a very hard time focusing. Approximately 2 hours into my flying I felt sudden and extreme pressure in my head and nearly blacked out. I immediately landed and stopped flying. Two days later I tried flying again and the exact same thing happened again after 20 minutes. The burning in my neck intensified and was now accompanied by dizziness, nausea, disorientation, confusion, uncontrollable shaking, and tinkling in my toes and fingers. I immediately went to my hometown doctor and he diagnosed me with vertigo. He prescribed me meclizine on Friday 02/05/2021. I took the medicine as prescribed all weekend with no relief. Monday 02/08/2021 I made an appointment for that Wednesday at the Institute. During Wednesday 02/10/2021-02/11/2021 I had roughly 10-15 test performed on me including balance, eye and hearing test, CT scan, MRI, and measured my spinal fluid pressure. The physician determined on 02/11/2021 that I had an allergic reaction to the Pfizer COVID vaccine the severely increased the pressure in my spinal cord and brain stem. That pressure causes my vision problems and ultimately ruptured my left inner ear breaking off several crystals in the process. I cannot fly with this condition. I'm currently taking Diamox to reduce the pressure in my spinal cord and brain stem.",Not Reported,,Yes,Not Reported,,Yes,N,02/01/2021,02/01/2021,0.0,PVT,None,None,None,,None,"['Acoustic stimulation tests', 'Balance test', 'Burning sensation', 'CSF pressure increased', 'Computerised tomogram', 'Confusional state', 'Disorientation', 'Dizziness', 'Head discomfort', 'Headache', 'Hypersensitivity', 'Inner ear disorder', 'Magnetic resonance imaging', 'Nausea', 'Paraesthesia', 'Presyncope', 'Tremor', 'Vertigo', 'Vision blurred', 'Visual field tests']",UNK,PFIZER\BIONTECH,SYR 1026794,HI,81.0,F,Left facial droop. Sent to Emergency Department via EMS 1/19/2021.,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/15/2021,01/19/2021,4.0,OTH,AMMONIUM LACTATE 12 % LOTION; ARTIFICIAL TEARS (OR EQUIVALENT); ASPIRIN 81 MG TABS; CALCIUM 600 MG + D3 400 IU TABS; CORN STARCH POWDER TOPICAL; DONEPEZIL 5 MG TAB; FLUOCINONIDE 0.05 % CREAM; LANTUS SOLOSTAR 100 UNIT/ML SOPN; LISINOPRIL 2.5,"DM, HTN, HYPERLIPIDEMIA, MILD COGNITIVE IMPAIRMENT, DEMENTIA, OBESITY","DM, HTN, HYPERLIPIDEMIA, MILD COGNITIVE IMPAIRMENT, DEMENTIA, OBESITY",,AMOXICILLIN (RASH),['Facial paralysis'],UNK,MODERNA,IM 1026801,CO,30.0,F,Central venous sinus thrombosis,Not Reported,,Yes,Yes,3.0,Not Reported,U,01/27/2021,01/29/2021,2.0,PVT,"LO-Estrin BCP, Flonase, Zyrtec, Azelastine nasal spray",None,Environmental allergies,,Ceclor - serum sickness Augmentin - skin rash,"['Cerebral venous sinus thrombosis', 'Computerised tomogram', 'Magnetic resonance imaging']",1,MODERNA,SYR 1026809,MN,46.0,F,"within 15 minutes hot all over and 30 minutes pain in my back down my leg into my knee and ankle. Hard to walk. progressivly got worse to point unable to walk without pain, lay down without pain. only able to sit. Steroids, NSAIDS, ICE, Whirlpool Therapy, message, chiropractor. Neurologist consult unable to walk. 2/1/21 MRI completed Circumferential disc bulge with superimposed left lateral recess and foraminal disc protrusion at L4-5 resulting in moderate to severe left foraminal stenosis and impingement of the exiting left L4 nerve root. There is contact of the traversing bilateral L4 nerve roots with some mass effect on the traversing left L5 nerve root. Correlate for left L4 and/or L5 radiculopathy. � 3. Circumferential disc bulge with superimposed right lateral recess and foraminal disc protrusion at L2-L3 with contact the traversing right L3 nerve root, but no nerve root compression. No compression of the exiting right L2 nerve root. Correlate for right L3 radiculopathy It is my impression that patient presents with acute onset of left L4 radiculopathy. Her MRI scan suggests a far lateral/foraminal left L4-L5 disk herniation. She also has some underlying lateral recess stenosis which is fairly mild. � I discussed the above findings with patient and her husband. I reviewed her MRI scan with the help of a spine model. I outlined both conservative and surgical approaches. However, given her findings and the severity of her pain currently, I think one could argue that a left L4-L5 microlumbar diskectomy via far lateral approach would be her most definitive option. I did outline this procedure in detail with the help of a spine model. I outlined the risks which include but are not limited to infection, bleeding complications, nerve root and/or cauda equina injury, cerebrospinal fluid leak, recurrent disk herniation, spinal instability, the possibility that she could require additional spine surgery in the future, and the possibility that her would not be relieved to her satisfaction. We also discussed trying a left L4-L5 foraminal steroid injection but she has had injections in the past and she actually felt like it gave her more pain. At this point she would like to go ahead and schedule the left L4-L5 microlumbar diskectomy via far lateral approach with METRx. This will be scheduled on an elective basis in the near future.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/19/2021,01/19/2021,0.0,PVT,"adalimumab, Ventolin, Albuterol, buspar, Cyclosporine, Allegra, antivert, Sinculair, synthroid, retin-A",none,"Hypothroidism, Autoimmune polyglandualar, Rheumatoid Arthritis",,"Sulfa, Morphine, Diaudid","['Arthralgia', 'Back pain', 'Condition aggravated', 'Feeling hot', 'Gait disturbance', 'Intervertebral disc protrusion', 'Lumbar radiculopathy', 'Magnetic resonance imaging spinal abnormal', 'Mobility decreased', 'Pain', 'Pain in extremity', 'Vertebral lateral recess stenosis']",2,PFIZER\BIONTECH,IM 1026841,WY,80.0,M,Resident passed away this morning. No signs or symptoms prior to his death of an issue with the vaccine. He was an end stage dementia resident at the nursing home.,Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/12/2021,1.0,SEN,Tylenol,,"Dementia, Hyperlipidemia, Hypertension, Osteoarthritis, Cerebral Infarction, COPD",,"Aloe, Tetracycline",['Death'],2,MODERNA,IM 1026846,GA,85.0,F,"Patients husband called office on February 3rd wanted to let us know his wife was in the hospital and my not be out to get her 2nd Moderna COVID-19 vaccine on Monday February 8th. I talked with the husband briefly about why his wife was hospitalized. He reported she got sick 2 days after getting her first COVID-19 vaccine. He states she had pneumonia, had a urinary tract infection and had to have a heart catherization with stent placement. We moved her second vaccine appointment to February 17th. The spouse came in on February 8th for his 2nd dose. He told me the doctors did not believe his wife's hospitalization was related to the first COVID vaccine and he said the doctor's told him that she needed her 2nd dose.",Not Reported,,Not Reported,Yes,7.0,Not Reported,Y,01/11/2021,01/13/2021,2.0,PUB,unknown,unknown,unknown,,NKDA,"['Catheterisation cardiac', 'Malaise', 'Pneumonia', 'Stent placement', 'Urinary tract infection']",1,MODERNA,IM 1026850,MA,76.0,M,"On Saturday 2/6/21 in the morning on the left side under armpit felt like he had a pulled muscle or something. It eventually radiated over up into the left quadrant of his chest where he could not push down on it. It was extremely painful by Monday. He has a history of esophageal spasms and exacerbated them to where he thought he was having a heart attack. He called his Cardiologist and told him to go to the ER. He went to the hospital Monday evening, he had two EKG's, had blood drawn 3 times, did sonograms looking for blood clots. He did inform them that he had the vaccine on Friday and they told him it was due to that. He went to nuclear medicine to get his lung checked for blood clots as well. All tests were negative. He saw his PCP today who told him that the lymph nodes were affected due to the vaccine. He has improved greatly, still has some slight discomfort which his PCP said would go away in time.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/05/2021,02/06/2021,1.0,MIL,"Allopurinol, baby aspirin, Atorvastatin, vitamin D3, Plavix, Folic acid, Atrovent inhaler, Toprol, Fabb, Renavite, Pantoprazole, Primidone, Ramipril, Zoloft, Renvela.",None.,"Has had three heart attack (the last 20-25 years ago), history of agent orange, high blood pressure, prostate cancer 2 years ago, diabetes, renal failure (on dialysis).",,None.,"['Blood test normal', 'Chest pain', 'Condition aggravated', 'Discomfort', 'Electrocardiogram normal', 'Lymphadenopathy', 'Magnetic resonance imaging thoracic normal', 'Oesophageal spasm', 'Pain', 'Ultrasound scan normal']",2,PFIZER\BIONTECH,IM 1026873,,66.0,F,"Pt admitted 1 day after 2nd dose Moderna COVID-19 Vaccine, for fever, muscle aches and diagnosed PNA. Pt stable on discharge with abx for PNA tx.",Not Reported,,Not Reported,Yes,2.0,Not Reported,,02/08/2021,02/09/2021,1.0,PVT,,,,,,"['Myalgia', 'Pneumonia', 'Pyrexia']",1,MODERNA, 1026892,KY,91.0,M,"RECEIVED COVID VACCINES ON 01/20/21 AND 02/10/21. 2/11/21 EMS CALLED BY FAMILY FOR ALTERED MENTAL STATUS AND ACCUCHECK OF 40 AND TAKEN TO ER HAD NEGATIVE COVID PCR ON 02/11/21 DIAGNOSED IN ER ADMITTED TO HOSPITAL INPATIENT WITH HYPOGLYCEMIA DUE TO DMII, AMS, UTI, AND PLEURAL EFFUSION",Not Reported,,Not Reported,Yes,,Not Reported,U,02/10/2021,02/12/2021,2.0,PVT,,,,,ACE INHIBITORS,"['Bacterial test positive', 'Blood glucose decreased', 'Hypoglycaemia', 'Mental status changes', 'Occult blood positive', 'Pleural effusion', 'Protein urine present', 'SARS-CoV-2 test negative', 'Type 2 diabetes mellitus', 'Urinary occult blood positive', 'Urinary tract infection', 'Urine analysis abnormal', 'White blood cell count increased', 'White blood cells urine positive']",2,PFIZER\BIONTECH,IM 1026921,AR,78.0,F,"HISTORY OF PRESENT ILLNESS: Pleasant 78-year-old female with history of lung cancer with remote partial pneumonectomy, some element of COPD and chronic respiratory failure on home oxygen therapy. She presents with worsening shortness of breath, which started rather abruptly the day prior to presentation. On arrival to the ED she was mildly tachypneic and slightly tachycardic and appeared to be in mild respiratory distress. Her O2 had been titrated to 4 L/m nasal cannula in order to sustain SaO2 values in the 90% or above range. Patient also noted to have pallor. No hematemesis, melena, hematochezia, abdominal pain, fever, cough or known exposure to COVID. Patient reports having received her first COVID vaccination just over one 1 week ago. A hypochromic microcytic anemia, progressive, was noted with a hemoglobin of 7.4 g/dL. Patient reported that she was up-to-date on EGD and colonoscopy within the past year without findings of acute pathology or bleeding. A CTA of the chest was conducted with findings of bilateral pulmonary emboli. She denies lower extremity swelling, pain or tenderness. Patient placed in observation in order to provide palliative blood replacement therapy and commence with anticoagulation for venous thromboembolism. DISCHARGE SUMMARY/OBSERVATION COURSE: Uneventful observation course for this pleasant 78-year-old female who presented with somewhat sudden worsening of her chronic shortness of breath and was found to have CTA evidence of bilateral pulmonary emboli. This in the setting of a progressive iron deficiency anemia without evidence of active clinical gastrointestinal bleeding. The patient received 2 units of packed red blood cells in a palliative fashion for her presenting hemoglobin of 7.4 g/dL. Posttransfusion hemoglobin was 10.1 g/dL. Concurrently, she was placed on weight-based low molecular weight heparin for full anticoagulation. I examined the patient on the morning of February 12 and found her to be nondistressed. Her SaO2 value was 96% on 4 L/m nasal cannula O2. Recall that her baseline flow rate historically had been 2 L/m his cannula. Etiology of the patient's thromboembolism uncertain. She had no clinical findings of unilateral or bilateral lower extremity swelling or tenderness. Patient noted to be a survivor of both breast and lung cancers but without known evidence of active persistent malignancy. Of interest, she had received a COVID-19 vaccine just over one week prior to presentation. I contacted pharmacy in this regard and encouraged him to report possible adverse event via VAERS. I recommended a course of rivaroxaban and provided a prescription with a VTE dosing schedule. Patient was advised to followup with Dr in 10 days. M.D., Hospital Medicine MD Feb 12, 2021 08:40",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/04/2021,02/10/2021,6.0,PVT,Famotidine 20mg tab - 1 tab PO BID; Hydrocodone/APAP 5-325mg - 1 tab PO Q6H PRN Pain,,1. History of breast cancer. 2. History of lung cancer. 3. COPD. 4. Osteoarthritis. 5. Coronary artery disease,,"Aspirin, Cephalexin, Sulfa Drugs","['Angiogram', 'Angiogram abnormal', 'Chest X-ray', 'Dyspnoea', 'Electrocardiogram', 'Embolism venous', 'Haematocrit', 'Haemoglobin decreased', 'Hypochromic anaemia', 'Iron deficiency anaemia', 'Metabolic function test', 'Occult blood', 'Pallor', 'Pulmonary embolism', 'Respiratory distress', 'SARS-CoV-2 test', 'Tachycardia', 'Tachypnoea']",1,MODERNA,IM 1026952,KY,73.0,M,"1st dose COVID vaccine 1/30/21; developed shortness of breath 2/7/21; worsening symptoms SOA, falls, chest pain; seen in ED on 2/12/21; Admitted to Hospital for severe sepsis, acute respirator failure.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/30/2021,02/07/2021,8.0,PVT,,,,,,"['Acute respiratory failure', 'Chest pain', 'Dyspnoea', 'Fall', 'Sepsis']",1,PFIZER\BIONTECH,IM 1026980,OH,80.0,M,Patient reported to Emergency room on 01/23/2021 with complaint of nausea. According to ER record patient reported he received a COVID 19 vaccine Pfizer the day before. Work up in the ER (CT ABD PELVIS) reveal a clotted of SMA. CT CHEST REVEALED BILATERAL PULMONARY EMBOLUS. THE PATIENT WAS TRANSFERRED TO THE STATE HOSPITAL. HE WAS SCHEDULED FOR EMERGENT VASCULAR SURGERY WHICH WAS CANCELLED AS THE PATIENT DIED SHORTLY AFTER HIS ARRIVAL.,Yes,01/25/2021,Not Reported,Yes,2.0,Not Reported,N,01/22/2021,01/23/2021,1.0,PUB,"METFORMIN, PIOGLITAZONE, NORTRIPTYLINE, TERAZOSIN, RISPERDONE, VIT D 3, DEPO-TESTOSTERONE, LOSARTAN, FLUTICASONE, NTG SL, CRESTOR, PROSCAR, ZOLOFT, MONTELUKAST, HYDROXYZINE, CARAFATE, OMEPRAZOLE, REGLAN, CENTRUM SILVER.",NONE,"DIABETES, MOOD DISORDER, ELEV CHOL, CAD, HTN, BPH, DIABETIC NEUROPATHY, ENVIROMENTAL ALLERGIES, LOW VIT D, HYPOGONADISM, GERD",,NKDA,"['Computerised tomogram abdomen abnormal', 'Computerised tomogram pelvis abnormal', 'Computerised tomogram thorax abnormal', 'Death', 'Nausea', 'Pulmonary embolism', 'Thrombosis']",UNK,PFIZER\BIONTECH, 1026994,MO,80.0,M,"Patient began feeling ill within 24 hours of getting second COVID19 vaccination. Presented to our hospital the evening of 1/28/21 with generalized weakness, fevers, near syncope. Extensive workup revealed likely hemophagocytic lymphohistiocytosis syndrome attributed to reaction to vaccine. Patient treated with blood transfusions, corticosteroid (dexamethasone 20mg) and folic acid 1mg daily. Patient also developed rectus sheath hematoma attributed to vaccine/reaction. Patient continues to remain hospitalized 15 days later. Clinically stable, yet critically ill with no significant / some worsening of laboratory results.",Not Reported,,Yes,Yes,15.0,Not Reported,N,01/26/2021,01/27/2021,1.0,MIL,"famotidine, metoprolol, pantoprazole, trazodone",,"Gout, hypertension, anemia, carotid atherosclerosis, carpal tunnel syndrome, chronic kidney disease, GERD, melanoma, hyperlipidemia, BPH, mesothelioma of small bowel, osteoarthritis",,lidocaine,"['Abdominal wall haematoma', 'Asthenia', 'Bicytopenia', 'Biopsy bone marrow abnormal', 'Blood fibrinogen', 'Blood fibrinogen normal', 'Blood triglycerides normal', 'Computerised tomogram abnormal', 'Haemoglobin decreased', 'Haemophagocytic lymphohistiocytosis', 'IL-2 receptor assay', 'Malaise', 'Platelet count decreased', 'Presyncope', 'Pyrexia', 'Serum ferritin increased', 'T-lymphocyte count increased', 'Transfusion', 'Vaccination complication', 'White blood cell count decreased']",2,MODERNA,IM 1026998,IN,65.0,M,"never symptoms of heart condition with no medication ,age 65, the day after shot, I had severe chest pains left side of chest. went to hospital and had 99% blockage widow maker and another blockage. 6 living siblings, no heart condition in family, neither parent with heart condition prior to mother at age 90. Not sure if its connected to vaccine, I would like to know others had same, hopefully help other people",Not Reported,,Yes,Yes,3.0,Yes,N,02/05/2021,02/06/2021,1.0,PHM,"C D3 zinc , no prescriptions",cancer of prostate 11/2020 stage 1,none,,none,"['Cardiac disorder', 'Chest pain', 'Stent placement']",1,MODERNA, 1027010,SC,45.0,M,"Pt received vaccine on 1/22/21. On 1/31/21 he presented to urgent care with fever and morbiliform rash. He tested negative for the flu and was given empiric oseltamivir. He had persistent fever and was given doxycycline and ceftriaxone by urgent care on 2/2. On 2/4 at urgent care he was noted to be hypotensive and referred to ER. He had findings of cardiogenic shock and intra-aortic balloon pump was placed. He was treated for acute heart failure with improvement in symptoms. He was also treated for pneumonia with piperacillin/tazobactam as well as amoxicillin / clavulanic acid. He was discharged with resolved fever, resolved rash, and improvement in EF based on cardiac MRI. Workup for other viral causes of myocarditis was negative.",Not Reported,,Yes,Yes,7.0,Not Reported,Y,01/22/2021,01/30/2021,8.0,PVT,"Zinc, Vitamin C, and Vitamin D3","COVID-19, 12/30/21",None,,No known allergies,"['Adenovirus test', 'Angiogram pulmonary abnormal', 'Antinuclear antibody negative', 'Blood culture negative', 'Brain natriuretic peptide decreased', 'Brain natriuretic peptide increased', 'C-reactive protein increased', 'COVID-19', 'Cardiac failure acute', 'Cardiogenic shock', 'Catheterisation cardiac', 'Coxsackie virus test positive', 'Cytomegalovirus test negative', 'Echocardiogram', 'Echovirus test negative', 'Ejection fraction decreased', 'Epstein-Barr virus antibody positive', 'Fibrin D dimer', 'Human herpes virus 6 serology negative', 'Hypotension', 'Influenza virus test negative', 'Intra-aortic balloon placement', 'Left atrial dilatation', 'Left ventricular dysfunction', 'Left ventricular hypertrophy', 'Lung consolidation', 'Magnetic resonance imaging heart', 'Mediastinitis', 'Mitral valve incompetence', 'Mycoplasma test negative', 'Myocarditis', 'Parvovirus B19 test negative', 'Pericardial effusion', 'Pericarditis', 'Pleural effusion', 'Pneumonia', 'Pneumonitis', 'Polymerase chain reaction', 'Pulmonary mass', 'Pyrexia', 'Rash morbilliform', 'Right atrial dilatation', 'SARS-CoV-2 test positive', 'Sarcoidosis', 'Tricuspid valve incompetence', 'Troponin']",UNK,PFIZER\BIONTECH, 1027035,KY,49.0,F,"1st vaccine 12/29/20; 2nd dose 2/11/21; developed visual changes 12/12/21, seen and referred to ED, admitted to Hospital.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/11/2021,02/12/2021,1.0,PVT,,,,,,['Visual impairment'],2,PFIZER\BIONTECH,IM 1027051,CA,78.0,F,"Few minutes post vaccination, after moving to observation area via wheelchair, the patient complained of dizziness. She took glucose tabs she had brought with her. Staff wheeled her to Triage # 1. Her eyes rolled back in her head and she lost consciousness. Staff (paramedics on site) transferred her to gurney and started compressions. AED placed, V- Fib was rhythm, Shock # 1 given, CPR resumed. Shocked again. Fire truck and additional EMT arrived on site and took over care. Epinephrine was given 3 times via intra-osseous route, Amiodarone given intra-osseous route. Additional defibrillation with on site AED for a total of 6-7 times. Patient had good chest rise with ambu-bag, no airway obstruction or peri-oral edema noted. Code called at 12:40 PM.",Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,OTH,Humulin 70/30 B 12 Aspirin 81 mg Hydralazine Plavix Isosorbide MN ER Metoprolol Simvastatin Lisinopril Women's 1 a Day vitamin Calcium with D3 Iron Glucose Tablets,"Patient not feeling well this morning prior to arrival, complaints of shortness of breath",Diabetes Status Post MI x 4 Status Post left stent Status Post right stent Breast CA Status Post Bilateral Mastectomy,,No known allergies,"['Cardio-respiratory arrest', 'Cardioversion', 'Death', 'Dizziness', 'Eye movement disorder', 'Intraosseous access placement', 'Loss of consciousness', 'Resuscitation', 'Ventricular fibrillation']",1,PFIZER\BIONTECH,IM 1027056,NY,70.0,M,"Loss of appetite evening of 2/11/2021. 6:30 AM 2/12/21 became weak, diaphoretic, blood sugar 474, primary care physician contacted, instructed by physician on call to go to the Emergency Room, IV fluids, insulin in ER, admitted",Not Reported,,Not Reported,Yes,,Not Reported,N,02/11/2021,02/12/2021,1.0,PUB,Metformin 1000 mg by mouth twice a day Atorvastatin 40 mg 1 tablet by mouth daily,Cold symptoms in January now resolved,Diabetes,,No known allergies,"['Asthenia', 'Blood electrolytes', 'Blood glucose increased', 'Chest X-ray', 'Computerised tomogram head', 'Decreased appetite', 'Electrocardiogram', 'Hyperhidrosis', 'Influenza virus test', 'Myocardial necrosis marker', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,IM 1027063,CA,69.0,F,"Patient sitting in chair, alert and oriented x 3, skin color was ashen. Patient felt strange over her chest, light headed, patient said she feels like she was going to pass out immediately after vaccine administration. VS 100/60 mmHg, pulse 64, RR 22. Patient complaints of headache, nausea and skin clamy and warm. Site manager made aware, o2 @ 2 L via nasal cannula administered. EMS transport to hospital. Daughter was made aware via VM, unable to reach 3x attempts.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/12/2021,02/12/2021,0.0,OTH,"Calcium, d3, B complex, antidepressant",None,Osteoporosis,,"tetracycline, codeine","['Chest discomfort', 'Cold sweat', 'Dizziness', 'Feeling abnormal', 'Headache', 'Nausea', 'Pallor', 'Presyncope', 'Skin warm']",1,PFIZER\BIONTECH,IM 1027071,WA,101.0,M,"Adverse reaction to the vaccine started with variable weakness beginning 1/29/2021. On 1/30/21 around 8:30pm, he needed assistance in the bathroom related to weakness and had what was later identified as a stroke with left side weakness and slurred speech. In accordance with his wishes, he had care at home. Due to his advanced age and frailty, a CT scan was not pursued. The 325 mg of aspirin that he was previously taking daily was discontinued. After the stroke, he needed total care. Hospice was established at home. Nursing assistant care was delivered by daughter. Death followed 9 days later (2/9/2021).",Yes,02/09/2021,Not Reported,Not Reported,,Yes,N,01/28/2021,01/29/2021,1.0,PUB,"BP meds x3, Statin, Thyroid, Aspirin, Multivit, Calcium, Vit D",Very elderly,Previous heart bypass surgery (1995) and later two stents between 1995-2000,,None,"['Asthenia', 'Cerebrovascular accident', 'Death', 'Dysarthria', 'Hemiparesis']",2,PFIZER\BIONTECH,IM 1027078,TX,56.0,F,"Anaphylaxis, itching, tightness of the throat, shortness of breath, low oxygen levels Treatment: 1 Benadryl 1130am, 1 Epipen 1155am, 1 Epipen 1225, steroids intravenously 1pm Outcome: Released home",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/11/2021,02/11/2021,0.0,PVT,NO,No,"Diabetes, high blood pressure, hypothyroidism, liver/kidney issues",,"Septra, Keflex, avocado, watermelon, banana, celery (uncooked)","['Anaphylactic reaction', 'Dyspnoea', 'Oxygen saturation decreased', 'Pruritus', 'Throat tightness']",2,PFIZER\BIONTECH,IM 1027123,CA,93.0,M,"Prt received 2nd dose of Covid 2/4 and 2/5 was found to have significant short of breath with RR 40, temp 103 and 02 sat 80%. prt was sent to hospital where he was tested positive for Covid and started treatment with Decardron and Remedesivir and on BIPAP mask to help with breathing and prt response to the treatment and able to discahrged after 3 days hospitalization He was hospitalized from 2/5-2/08 and discharged",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/04/2021,02/05/2021,1.0,PVT,"Fosamax, prn ventolin inhaler, Eliquis, Vit D, finasterid, Advairs, prn tussin, Combivent inhaler, claritin, losartan, prn mylanta, montelukast, omeprazole, senekot,, flomax, spirivia. prn ultram",no acute illnesses,"osteoporosis, COPD, paroxysmal atrial fibrillation, MAC, BPH, Osteoarthritis, HTN, CKD stage III, hyperlipidemia, GERD, gluacoma suspect, BPPV, arthritis. vascular dementia, hearing loss",,NKDA,"['Bilevel positive airway pressure', 'COVID-19', 'Chest X-ray', 'Dyspnoea', 'Laboratory test', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 1027141,OR,79.0,M,The patient reported feeling well. I discussed with him the Covid-19 vaccine and he was able to state that he wanted it and to sign his consent form. The facility reported they had discussed this with him and he had agreed prior to my visit.,Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,SEN,"Acidophilus Capsule BID, Metamucil (Generic) 1 packet/day, Metformin HCL 500 Generic BID, Omeprazole 20 mg Daily, Potassium Cloride ER 20 MEQ tablet PO daily with breakfast, Prenatal Vitamin plus low iron daily with breakfast, Tamsulosin Hc","None, Last prior illness was November 2020 he had Cdiff and was at Hospital but per facility the patient was fully recovered from this.","Forgetfulness/Mild Dementia, Diabetes, Obese, Urinary Flow Issues all per facility and MAR",,NKDA,['Death'],1,MODERNA,IM 1027158,CA,95.0,F,"death. Per son pt was not feeling well after the vaccination ""like her legs were weak."" Son found the mom in her bed 1am on 2/12/2021 unresponsive.",Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/12/2021,2.0,PVT,"acetaminophen 500 mg oral tablet, 500 mg= 1 tabs, Oral, TID, 1 refills ammonium lactate 12% topical lotion, 1 app, Topical, BID, 2 refills calcium (as carbonate)-vitamin D 600 mg-400 intl units oral tablet, 1 tabs, Oral, BID, 4 refills C",CKD-4 Dementia Incontinence of stool Insomnia Skin breakdown right gluteus,Chronic insomnia CKD Constipation Dementia Hepatitis B non-immune Onychomycosis Osteoporosis NOS Stool incontinence x2 ( 2 months and one week ago while out on stret) TIBC - Total iron binding capacity low Tinea pedis Vitamin B12 deficiency Vitamin D deficiency,,NKDA,"['Death', 'Malaise', 'Muscular weakness', 'Unresponsive to stimuli']",1,MODERNA,IM 1027218,NY,46.0,F,"Received the COVID vaccination on 1/28/2021, that evening developed chest pain that went patient spoke with her father, the decision was made for further evaluation, she was transported to ER via ambulance and admitted for overnight observation, cardiac workup was negative and chest pain was attributed to a vaccine reaction.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/28/2021,01/29/2021,1.0,PVT,,,,,,"['Cardiac monitoring', 'Chest pain', 'Laboratory test']",UNK,MODERNA,IM 1027247,TX,82.0,M,"Fever, chills, Fatigue beginning night of vaccination until 1week later when it resulted in ER visit.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/28/2021,02/04/2021,7.0,PVT,,anemia,myelodysplastic syndrome atrial fibrillation,,none,"['Acute myeloid leukaemia', 'Biopsy bone marrow abnormal', 'Chills', 'Fatigue', 'H1N1 influenza', 'Haemoglobin decreased', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1027258,CA,91.0,F,"Resident was given the Pfizer vaccine on January 22, 2021, nausea and shortness of breath was taken to the Hospital on the 23rd of January and passed on the 24, 2021",Yes,01/24/2021,Not Reported,Yes,2.0,Not Reported,N,01/22/2021,01/22/2021,0.0,PVT,"Eliques 2.5 mg, carvedilol 6.25, hydralazine 50 mg,tradjenta 5mg,","kidney failure, diabetic","congestive heart failure, dialysis",,no,"['Death', 'Dyspnoea', 'Nausea']",UNK,PFIZER\BIONTECH, 1027275,WA,76.0,F,Unknown onset of altered mental status. Last time known well was day of vaccination 2/3/2021. Found altered on 2/9/2021. Working diagnosis is encephalopathy: MRI unrevealing. CVA vs other etiology,Not Reported,,Not Reported,Yes,,Not Reported,N,02/03/2021,02/09/2021,6.0,PVT,Aspirin Albuterol as needed,None,COPD Lacunar Stroke,,PCN,"['Angiogram', 'Cerebrovascular accident', 'Computerised tomogram', 'Encephalopathy', 'Laboratory test', 'Magnetic resonance imaging normal', 'Mental status changes']",1,MODERNA,IM 1027300,KS,90.0,M,"Nausea, vomiting and generalized weakness.",Yes,02/12/2021,Not Reported,Yes,2.0,Not Reported,N,02/06/2021,02/11/2021,5.0,UNK,Unknown,None known,"Aortic aneurysm, aortic stenosis, CAD, HTN, CHF, A-Fib, HLD, Ischemic heart failure, pacemaker, V-Fib, PVD, palpitations, hypotension, and small bowel obstruction.",,Unknown,"['Asthenia', 'Nausea', 'Vomiting']",UNK,MODERNA,UN 1027307,AZ,75.0,F,"weakness, falls, fever, SIRS - hospitalized for 2 days at Medical Center - 2/5/2021 - 2/7/2021",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/04/2021,02/04/2021,0.0,PVT,"amlodipine, aspirin, atorvastatin, chlorthalidone, citalopram, dicyclomine, gabapentin, levothyroxine, lisinopril, olanzapine, phenytoin",no acute illness prior to vaccination,"bipolar disorder, hypertension, anxiety, lupus, history of stroke, osteoporosis, schizoaffective disorder, seizure disorder among other diagnoses",,none,"['Asthenia', 'Blood potassium decreased', 'Electrocardiogram QT prolonged', 'Fall', 'Hypokalaemia', 'Pyrexia', 'Systemic inflammatory response syndrome']",1,MODERNA,IM 1027317,FL,37.0,M,"Severe joint pain, headaches, paresthesias, severe fatigue, lethargy, difficulty concentrating",Not Reported,,Not Reported,Not Reported,,Yes,N,01/26/2021,01/26/2021,0.0,SEN,"Dexmethylphenidate, bupropion, Keppra, Seroquel, Qvar, Elidel,",none,"add/adhd, depression, anxiety, asthma, allergic rhinitis, eczema,",pneumococcal vaccine 13 valent,"Tree and grass, (severe) Mold allergy (delayed hypersensitivity reaction), Pollen, Dust mite protein, thimerosol,","['Arthralgia', 'Disturbance in attention', 'Fatigue', 'Headache', 'Laboratory test', 'Lethargy', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 1027325,NJ,65.0,M,Atrial Fibrillation corrected by electrical cardioversion.,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/03/2021,02/05/2021,2.0,PVT,"Metoprolol, Lisinopril, Simvistatin, aspirin, Vitamin D, Turmeric",none,high blood pressure,,none known,"['Atrial fibrillation', 'Cardioversion']",1,PFIZER\BIONTECH,SYR 1027371,FL,73.0,M,SEIZURE at exactly 28 minutes post-injection. Unconscious for 34 minutes. Observed at clinic until ambulance transportation to Medical Center,Not Reported,,Yes,Yes,1.0,Not Reported,Y,02/09/2021,02/09/2021,0.0,OTH,"Mirtazepine, Tamsulosin, Colonopam",None,None,,None known,"['Blood pressure measurement', 'Electrocardiogram', 'Electroencephalogram', 'Loss of consciousness', 'Oxygen saturation', 'Seizure']",1,MODERNA,IM 1027502,MO,86.0,M,"My dad received his first COVID vaccine on January 14, 2021. On January 16, 2021 he ate breakfast around 7:00 am and went back to his room. When the staff checked on him around 8:00 am they found my dad unresponsive. His blood pressure was over 220 and his pulse was 43. They began manual CPR until the paramedics arrived, but my dad died.",Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/16/2021,2.0,SEN,"Symbicort, Xanax, Albuterol, Flomax, Polyethylene glycol",,COPD,,,"['Death', 'Resuscitation', 'Unresponsive to stimuli']",UNK,MODERNA, 1027503,MA,77.0,M,Patient died on 02/08/2021,Yes,02/08/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/08/2021,6.0,SEN,,,,,,['Death'],2,PFIZER\BIONTECH, 1027559,,65.0,F,"chest tightness and difficulty breathing since receiving vaccine, found to be hypoxic in hospital",Not Reported,,Not Reported,Yes,,Not Reported,N,02/05/2021,02/13/2021,8.0,PVT,"Lexapro, trelegy, singulair, rosuvastatin",,copd,,pcn,"['Angiogram', 'Chest X-ray', 'Chest discomfort', 'Dyspnoea', 'Electrocardiogram', 'Hypoxia', 'Laboratory test']",2,PFIZER\BIONTECH,IM 1027563,CT,24.0,M,"Migraine, Seizures.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/01/2021,02/03/2021,2.0,WRK,Lorazepam.,Covid Positive December 27th.,,,,"['Migraine', 'Seizure']",2,MODERNA,SYR 1027570,PA,59.0,F,"Received 2nd Moderna 2/10/21. Later that evening felt feverish. Next morning 2/11/21 had a syncopal event in her bathroom. Presented to the ER and was observed overnight and was seen by urology. Was thought to possibly have had a seizure. MRI, EEG was unremarkable. Was not initiated on any meds.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/10/2021,02/11/2021,1.0,PVT,,,,,,"['Electroencephalogram normal', 'Magnetic resonance imaging normal', 'Pyrexia', 'Syncope']",2,MODERNA,UN 1027580,FL,56.0,F,"11 hours after dose 2 I experienced extreme aches, chills, fever, nausea, brain fog, rapid heartbeat, shortness of breath and dizziness. Sx eased after 8 hours. Shortness of breath and heart palpitations have continued since and I am currently in hospital for cardiac symptoms. I have never had cardiac or other health issues",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/02/2021,02/02/2021,0.0,PVT,Tylenol,None,None,,None,"['Blood test', 'Chills', 'Dizziness', 'Dyspnoea', 'Feeling abnormal', 'Heart rate increased', 'Nausea', 'Pain', 'Palpitations', 'Pyrexia']",1,MODERNA,SYR 1027586,NY,44.0,M,PAIN TO ARM AND NECK. THEN DROOPING ON RIGHT SIDE OF FACE,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/08/2021,0.0,PVT,OMEPRIZOL,,GERD RINOSITUS,,PENNICILLEN,"['Facial paralysis', 'Magnetic resonance imaging', 'Neck pain', 'Pain in extremity']",2,MODERNA,IM 1027604,PA,74.0,F,Admitted to hospital in acute kidney and liver failure. Pre-existing conditions but not advanced. Only change in routine was vaccine. Still in hospital trying to diagnose cause and get organs functioning correctly.,Not Reported,,Yes,Yes,5.0,Not Reported,N,02/06/2021,02/08/2021,2.0,PVT,All associated with below chronic conditions,N/a,"Cirrhosis, Congestive Heart Failure, Diabetes, Autoimmune Hepatitis",,Sesame,"['Acute hepatic failure', 'Acute kidney injury', 'Liver function test abnormal', 'Renal function test abnormal']",1,MODERNA,SYR 1027613,MN,87.0,F,"Mom fell the next day 1/13 and was brought to hospital emergency then released about half day later (broke her eye glasses in the fall), she had second vaccine on 2/9/21 and fell the next day 2/10 and was brought to hospital and has fractured rib and possibly two more fractured ribs. Is this a huge coincidence or did she have really bad reactions to the covid vaccines? Should she have been observed for 24 hours afterwards by the assisted living facility, had a family caretaker watch her for 24 hours, Pharmacy should have observed for 24 hours?",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/12/2021,01/13/2021,1.0,SEN,"high blood pressure, cholesterol, diabetes",depression,"high blood pressure, cholesterol, diabetes",,aspirin,"['Fall', 'Rib fracture']",UNK,MODERNA, 1027619,PA,41.0,M,Swollen leg/pain- taken to urgent care- became unresponsive - CPR initiated- expired,Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/11/2021,1.0,OTH,,no acute,"Anemia, unspecified Congenital malformation syndromes predominantly associated with short stature Constipation, unspecified Dysphagia, unspecified Gastro-esophageal reflux disease without esophagitis Illness, unspecified Intermittent explosive disorder Moderate intellectual disabilities Neuromuscular dysfunction of bladder, unspecified Other iron deficiency anemias Other specified eating disorder Pica of infancy and childhood Thrombocytopenia,",,NKA,"['Death', 'Pain in extremity', 'Peripheral swelling', 'Resuscitation', 'Unresponsive to stimuli']",UNK,PFIZER\BIONTECH, 1027740,FL,87.0,F,"After only a couple days post-vaccine, patient was unable to sit up, walk or feed herself. Taken to ER via EMS on 2/7/21. Nothing remarkable discovered. Slight dehydration, scant UTI bacteria. She is now in the Hospice contracted bed at the hospital returning to hospice care at home with 24/7 aides to feed and car for her.",Not Reported,,Not Reported,Yes,4.0,Yes,N,01/22/2021,01/27/2021,5.0,SEN,"Carvidiol, Midodrine, Seroquel, Remeron, Vit D3, multi-vitamin, Xylatan","vascular dementia, glaucoma, macular degeneration","vascular dementia, glaucoma, macular degeneration",,penicillin & sulfa,"['Chest X-ray', 'Computerised tomogram', 'Dehydration', 'Feeding disorder', 'Gait inability', 'Laboratory test', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Urinary tract infection', 'Urinary tract infection bacterial']",1,PFIZER\BIONTECH, 1027757,PA,77.0,F,Death,Yes,01/28/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/28/2021,3.0,UNK,,,,,,['Death'],1,MODERNA,SYR 1027816,KS,51.0,F,"2nd COVID vaccine 2/6/21 @10:02am. Episode of vasovagal syncope 2/7/21 @5:00a. Also side effects of fever, N/V, diarrhea and weakness of approx. 1 hour. Unable to eat/drink. Presented to the ED 2/8/21 @1:30p. Rec 1L LR, Tylenol, benadryl and compazine @5:25p. CT head @6:00p. I was d/c from the ED 2/8/2021 @7:47p. Severe vertigo 2/7 @5:00a-2/9 @4:00p. Profound hearing loss noted @11:30a 2/10/21. Appt with audiologist 2/12/2021 @8:00a, ENT 2/12/2021 @1:50p. Hearing test X2 shows near 100% hearing loss in R ear. Rec steroid injection behind R eardrum 2/12/21 @2:30p. PO steroid taper 2/12/21 @5:30p.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/06/2021,02/07/2021,1.0,PVT,"Metoprolol, levothyroxine, osteo bi-flex, vitamin D, acetaminophen, lotradine",None,"HTN, tachycardia, hypothyroidism, left nephrectomy in 2002 (current kidney function is normal)",,"Demoral, paper tape, liquid adhesives, vicryl","['Acoustic stimulation tests abnormal', 'Asthenia', 'Blood lactic acid', 'Blood magnesium', 'Computerised tomogram head', 'Deafness', 'Decreased appetite', 'Diarrhoea', 'Differential white blood cell count', 'Feeding disorder', 'Fluid intake reduced', 'Full blood count', 'Metabolic function test', 'Nausea', 'Pyrexia', 'Syncope', 'Vertigo', 'Vomiting']",2,MODERNA,IM 1027862,OH,80.0,F,lower extremity weakness the next day and SVT 2 days after receiving vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,SEN,,COVID 19,"CAD, Hypertension, Lupus, Diabetes",,Daypro; Plaquenil; Penecillin,"['Muscular weakness', 'Supraventricular tachycardia']",1,PFIZER\BIONTECH,IM 1027863,VA,53.0,M,achilles tendon rupture while playing pickle ball. Surgery required on 12/31/20,Not Reported,,Not Reported,Not Reported,,Yes,N,12/23/2020,12/26/2020,3.0,PVT,"Omega 3, Vit D, Vit B12",none,"asthma, hemochromatosis, lumbar spinal stenosis",,"Lodine, Horse Serum","['SARS-CoV-2 test negative', 'Sports injury', 'Surgery', 'Tendon rupture']",1,PFIZER\BIONTECH,IM 1027925,AZ,59.0,F,"Parathesia, dysphagia, fever, nausea, vomiting, loss of voice, loss bowel movement",Not Reported,,Not Reported,Yes,21.0,Yes,N,01/21/2021,01/21/2021,0.0,PVT,"Kclor, Dyzaide, Coreg, MVI",None,"HTN, SVT, Eczema",,"cobalt, fragrances, lisinopril, morphine, nickel","['Anal incontinence', 'Aphonia', 'Computerised tomogram spine', 'Constipation', 'Dysphagia', 'Full blood count', 'Lumbar puncture', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging spinal', 'Metabolic function test', 'Nausea', 'Paraesthesia', 'Pyrexia', 'Urine analysis', 'Vomiting']",2,MODERNA,SYR 1027941,CA,48.0,F,"Intense soreness/pain in muscles ( arms, under breasts rib area, thighs, lower legs and ankles), blood in urine, pain in all major joints. difficulty walking and limited range of motion. Symptoms showed up after 7 days after vaccine was received. Presented to urgent care after test were don't I was hospitalized inpatient for 4 days. I was diagnosed with RHABDOMYOLYSIS, ABNL LIVER FUNCTION STUDY. CREATINE KINASE TEST OUTCOME WAS AT 41000.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/28/2021,02/04/2021,7.0,PVT,"multi vitamins, calcium, B vitamins",None,None,,None,"['Arthralgia', 'Blood creatine phosphokinase increased', 'Blood test', 'Blood urine present', 'Gait disturbance', 'Joint range of motion decreased', 'Liver function test abnormal', 'Musculoskeletal chest pain', 'Myalgia', 'Pain in extremity', 'Rhabdomyolysis']",2,PFIZER\BIONTECH,IM 1027951,NY,92.0,F,"Pt had mild dementia prior to vaccine. Was able to walk, toilet herself, feed herself,. After Vaccine pt became bedbound within 12 hours, markedly confused, and anorexic",Not Reported,,Not Reported,Not Reported,,Yes,N,02/06/2021,02/07/2021,1.0,OTH,"Amlodipine, gabapentin, prednisone, Amitriptyline","Pulmonary Fibrosis, Mild Dementia, HTN, TAVR, loop recorder, neuropathy, diverticulosis",,,NONE,"['Bedridden', 'Computerised tomogram abdomen normal', 'Computerised tomogram head normal', 'Confusional state', 'Decreased appetite', 'Full blood count normal', 'Laboratory test normal', 'Metabolic function test', 'Urine analysis normal', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1027967,MI,76.0,M,"Patient received vaccination on 1/15/2021. Hemorrhagic Stroke on 1/20 , then diagnosed with complicated idiopathic coagulopathy",Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/20/2021,5.0,PVT,,none,"PMH: Acquired Deformity of toe- Hallux Rigidus, Actinic Keratosis, Anemia Macrocytic, Atherosclerosis, Atopic Dermatitis, Atrophy testis, Bph Local W/urinary Obstruct with LUTS, Cerumen Spondylosis, Cervicalgia, CKD stage 2, Colonic Diverticulosis, Dyspepsia, Dysphagia, Epitaxis, Esophageal Reflux, Hearing loss, Hepatic Cyst, Impaired fasting glucose, Lumbar spondylosis, Male Erectile Disorder, Microscopic Hematuria, Migraine,",,unconfirmed childhood allergy to penicillin,"['Coagulopathy', 'Haemorrhagic stroke']",1,MODERNA,IM 1027968,TX,32.0,F,"10 day Migraine and all over body aches and soreness, only relieved by steroid, muscle relaxer and botox injections, and anti inflammatory medications, sensitivity to bright lights and sounds, radiating warmth in core of body but cold extremities, severe fatigue and lethargy and irritability. Ringing in ears is loud.",Not Reported,,Not Reported,Not Reported,,Yes,U,02/02/2021,02/02/2021,0.0,PVT,Biotin supplements Vitamin D3 supplements Singular Methscopolamine,None,Allergies Arthritis,"18 months old, DpT reaction to pertussis- seizure",Pertussis,"['Blood test', 'Fatigue', 'Hyperacusis', 'Irritability', 'Lethargy', 'Migraine', 'Pain', 'Peripheral coldness', 'Photophobia', 'Skin warm', 'Tinnitus']",2,MODERNA,SYR 1028040,AZ,74.0,F,"Rash/welts developed over entire body (face, trunk, arms and legs) within 1 hour of receiving vaccine. Itching started that evening. Next day went to PCP who ordered 3 doses of prednisone 20mg and benadryl 25mg every 6 hours PRN. Day 2, rash/welts increased as well as itching. Evening of day 2, rash to legs progressed to purpura, temp of 102.7, chills and extreme pain to bilateral hips which prompted taking to ED and being admitted to progressive care unit.",Not Reported,,Yes,Yes,4.0,Not Reported,N,02/09/2021,02/09/2021,0.0,OTH,"HCTZ, Vit D, Ramipril, Clonidine, Sodium Bicarb, Lasix, Humalog, Acid controller, ASA, Clonidine, Atorvastatin, Diltiazam XR, soliqua pen injection",post op R eye cataract surgery,"diabetes type 2, chronic kidney disease, HTN, glacoma",,Seasonal allergies and allergies to sulfa antibiotics,"['Arthralgia', 'Blood creatinine increased', 'Blood pressure decreased', 'Blood urea increased', 'Body temperature increased', 'Chest X-ray normal', 'Chills', 'Computerised tomogram abdomen normal', 'Computerised tomogram normal', 'Computerised tomogram pelvis', 'Computerised tomogram thorax', 'Computerised tomogram thorax normal', 'Magnetic resonance imaging normal', 'Mean arterial pressure decreased', 'Pruritus', 'Purpura', 'Rash', 'SARS-CoV-2 test negative', 'Tachycardia', 'Urticaria', 'Vital functions abnormal', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1028101,IN,70.0,M,"Pt develops left leg pain The day after vaccination in AM subsequently drove approximately 150 miles On his way back stopped at his brothers place for lunch. He then collapsed coning down the steps, EMS started CPR. took him to ER Resuscitated briefly but went into CardioPulm Arrest again and PEA Resucitaion for aprox 1 hour but was unsuccessful. Noted to have Left leg more swollen than Right by 3 to 4 CM presumed to have died from massive Pulmonary embolism and inferior wall myocardial ischemia",Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/23/2021,1.0,PVT,Allopurinol 400mg Daily,Hyperuricemia Renal stone,Hyperuricemia Renal Stones,,Shellfish,"['Blood gases abnormal', 'Cardio-respiratory arrest', 'Death', 'Electrocardiogram abnormal', 'Hypoxia', 'Metabolic acidosis', 'Metabolic function test normal', 'Myocardial ischaemia', 'Pain in extremity', 'Peripheral swelling', 'Pulmonary embolism', 'Pulseless electrical activity', 'Resuscitation', 'SARS-CoV-2 test negative', 'Syncope', 'Troponin normal']",UNK,PFIZER\BIONTECH,IM 1028154,CA,81.0,F,"Approximately 75 minutes after vaccine had significant shortness of breath, extreme fatigue (difficulty walking to the bathroom). Over the next week and a half, blood pressure and heart rate swung widely (outside of normal range). Heart rate periodically dropped down into 30-40 range. Experienced whiteouts.",Not Reported,,Yes,Not Reported,,Not Reported,U,01/28/2021,01/28/2021,0.0,OTH,Verapamil 360mg/1x day (high blood pressure) Prevastatin 20mg/1x day (high blood pressure) Losartan potassium 100mg/1x day (high blood pressure) Metformin HCL 1000mg/2x day (diabetes) Levothyroxine 50mcg/1x day (Thyroid) Asprin 81mg ev,None,"High blood pressure, controlled Type 2 diabetes",,"Strawberries, tree pollen","['Blindness', 'Blood pressure abnormal', 'Dyspnoea', 'Fatigue', 'Gait disturbance', 'Heart rate decreased', 'Syncope', 'Tremor']",1,PFIZER\BIONTECH,SYR 1028166,TN,95.0,F,"Patient was found unresponsive on her kitchen floor about 9:45 AM on February 10, 2021 approximately 18 hours after receiving her first Covid-19 vaccination. Exact time of the event is unknown. She was known to get up between 6:30 and 7:30 AM. It appeared that she had not eaten breakfast nor taken any medication that morning. She was taken by ambulance to Medical Center where a CT scan showed an unrecoverable massive brain hemorrhage. She died at approximately 3:50 PM after the respirator was removed. She was sent to the local Medical Examiner afterwards.",Yes,02/10/2021,Not Reported,Yes,,Not Reported,N,02/09/2021,02/10/2021,1.0,PUB,"See Continuation Page MEDICATION, DOSAGE, FREQUENCY Coreg,6.25 mg,Twice daily Hydralazine HCL,10 mg,Twice daily Isosorbide mononitrate ,30 mg,Once Daily Warfarin,20.5 mg,per week Acyclovir ,800mg,4x Daily Atropine Sulphate, 1% Op Sol,Tw","Glaucoma, corneal virus in right eye, IBS","IBS with Constipation/Diarrhea, atrial fibrillation, heart failure, and osteoporosis. Had a known brain aneurysm that had been scanned annually which showed no signs of change. Dr. was her primary care physician and has most of her medical records. CNA gave her cardiology care. Endocrinologist, treated her osteoporosis and gave her a Prolia injection twice yearly. Her newest medication was Acyclovir, 800mg, 4x Daily prescribed by doctor for her right eye.",,ALLERGIC to monopril,"['Cerebral haemorrhage', 'Computerised tomogram head abnormal', 'Death', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,SYR 1028202,OR,77.0,F,Bleeding on the toe of foot. Complete sock from ball of foot to end of ties was soaked with blood. This was a spot that Would bleed when I had IV chemo therapy in 2012. Called Dr. And HHT. Clinic at Hospital,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,OTH,Thyroid. Calcium,None,"Cancer patient. Appendix, In remission HHT. Patient. Idler Weber Rendu",,Penicillin. Blood thinners,['Haemorrhage'],UNK,PFIZER\BIONTECH, 1028217,MI,72.0,M,DEATH,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,MIL,"Type 2 diabetes medication, Blood pressure Medication, arthritis medication. blood thinner medications",no,"arthritis, type 2 diabetes, back issues, blood pressure.",,no,['Death'],1,PFIZER\BIONTECH,SYR 1028220,CA,89.0,M,"on the night of 2/9/2021, patient was carrying a conversation in his sleep practically all through the night. The morning of 2/10/21 called 911 to ER.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,02/09/2021,02/09/2021,0.0,PVT,"atorvastatin 40 MG, tamsulosin 0.4 mg, losartan 25 mg, oxybutynin chloride er 5 mg, aspiring 81 mg Note: Admitted to ER on 2/10/2021. Hospital may have given him new medicine.","blood pressure, arthritis","blood pressure, arthritis. few years ago had a transient ischemic attack.",,none,"['Computerised tomogram head', 'Sleep talking']",1,PFIZER\BIONTECH,SYR 1028302,CA,84.0,M,"Shortness of Breath, Continuous Coughing with blood tinged spit, Blood Pressure 200/100, Oxygen level 84 began around 5:00 am with paramedics arriving and transporting to the hospital around 7:00 am.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,01/27/2021,01/28/2021,1.0,OTH,"Prescription - Prandin 0.5mg 3x daily, Tamsulosin cap 0.4mg 1x daily, Amlodipine .5mg 1x daily, Fenofibrate tab 48mg 1 daily PM, Isosorbide Mononitrate tab 60mg 1x daily, Carvedilol tab 12.5mg 2x daily, Clonidine 1x weekly, Lisinopril tab 4",,"Diabetes, High Blood Pressure, Congestive Heart Failure, Kidney Disease, High Cholesterol",,None,"['Cough', 'Dyspnoea', 'Electrocardiogram', 'Haemoptysis', 'Hypoxia', 'Oxygen therapy', 'Pneumonia', 'Renal failure', 'X-ray abnormal']",1,PFIZER\BIONTECH,SYR 1028352,FL,45.0,F,Only had sore arm with each dose but 3 weeks later lost my hearing overnight in my left ear. Profound deafness on audio gram.,Not Reported,,Not Reported,Not Reported,,Yes,N,01/01/2021,01/31/2021,30.0,OTH,"Zinc, women?s multi, fish oil, Letrozole",None,Breast cancer May 2020- no chemo,,None,"['Audiogram abnormal', 'Deafness', 'Deafness unilateral', 'Laboratory test normal', 'Magnetic resonance imaging normal', 'Pain in extremity', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 1028354,LA,65.0,F,On the 01/06/2021 I noticed that I had a fever of 100.9 I was really fatigued . I Thinking I was okay . I went to visit the nail shop and fainted.. I was rushed to the hospital . My heart was fluttering and racing . My blood pressure was also low .,Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/04/2021,01/06/2021,2.0,WRK,Asprin Pravastain Coveterol Metformin Ometherol Plavix,None,Diabetes Blood Pressure,,Shellfish Iodine Gabapetin Latex,"['Blood test', 'Cardiac flutter', 'Computerised tomogram', 'Echocardiogram', 'Electrocardiogram', 'Fatigue', 'Hypotension', 'Palpitations', 'Pyrexia', 'Syncope']",2,MODERNA,IM 1028368,CA,32.0,F,Miscarriage in first trimester. First dose received 12/22/2020 Conception date 01/03/2021 Second dose 01/27/2021 Miscarriage started 02/03/2021 First pregnancy. No other medical problems or pregnancy risks.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,02/05/2021,9.0,UNK,Prenatal vitamins,None,None,,None,"['Abortion spontaneous', 'Exposure during pregnancy']",2,PFIZER\BIONTECH,IM 1028433,CA,54.0,F,"Cellulitic Sweet's syndrome of lower extremity. Significant LLE erythema and pain out of proportion to exam that has continued to progress despite broad-spectrum antibiotics, now s/p OR cut down x3 with no e/o necrotizing fasciitis. Initially most c/f infection/cellulitis, however in discussion with ID, rheum, and derm and given progression of rash in s/o broad spectrum Abx and negative tissue cultures, now most suspicious for cellulitic variant of Sweet's syndrome (SS). Pathology report w/neutrohpliic inflammation w/evidence of ischemia, w/o evidence of infection, c/w Sweets Syndrome. While this is a rare disorder, it primarily occurs in the setting of recent infection or malignancy. Currently working up potentially triggers. Infectious work up thus far negative. Hematologic malignancy most often linked with SS, given new and worsening pancytopenia, will consult heme for recommendations for additional work up. Other potential triggers include vaccinations (question about COVID vaccine recently) and often idiopathic. Maintain of treatment for SS is steroids, dermatology currently managing dosing.",Not Reported,,Not Reported,Yes,14.0,Not Reported,,01/25/2021,01/30/2021,5.0,PVT,"acamprosate, albuterol, buspar, combivent, descovy, duelra, iron, lasix, gabapentin, ibuprofen, levalbuterol, lithium, ativan, provera, methadone, mirtazapine, protonix, seroquel, senna, thiamine, dolutegravir, lactulose",unknown,"HIV, EtOH cirrhosis, COPD, HCV s/p tx with SVR, PSA on methadone",,none,"['Acute febrile neutrophilic dermatosis', 'Cellulitis', 'Culture tissue specimen negative', 'Erythema', 'Infection', 'Inflammation', 'Ischaemia', 'Necrotising fasciitis', 'Pain in extremity', 'Pancytopenia', 'Rash', 'Surgery']",UNK,PFIZER\BIONTECH, 1028452,IA,88.0,F,"The patient suffered embolic strokes and was admitted to the hospital the day after she received her first COVID-19 vaccination. She has a history of strokes, with atrial fibrillation, but was faithfully taking her Eliquis at the time she suffered these recurrent strokes.",Not Reported,,Yes,Yes,9.0,Yes,N,02/04/2021,02/05/2021,1.0,SEN,amiodarone (PACERONE) 200 MG tablet Take 0.5 tablets by mouth daily. apixaban (ELIQUIS) 2.5 MG TABS tablet Take 1 tablet by mouth 2 (two) times daily. atorvastatin (LIPITOR) 40 MG tablet TAKE 1 TABLET BY MOUTH AT BEDTIME lisinopril (PRINI,none,"past medical history of RA, CAD with h/o MI, depression, h/o CVA, and atrial fibrillation on Eliquis. The patient was taking her Eliquis faithfully, administered by assisted living facility, and had not missed doses.",,Quinidine,"['Angiogram cerebral normal', 'Aortic valve incompetence', 'Atrioventricular block', 'Atrioventricular block second degree', 'Basal ganglia infarction', 'Bundle branch block right', 'Computerised tomogram head abnormal', 'Echocardiogram', 'Echocardiogram normal', 'Ejection fraction', 'Electrocardiogram abnormal', 'Embolic stroke', 'Left ventricular dysfunction', 'Left ventricular hypertrophy', 'Magnetic resonance imaging brain abnormal', 'Myocardial infarction', 'Myocardial ischaemia', 'Perfusion brain scan normal', 'Scan with contrast', 'Ultrasound Doppler abnormal', 'White matter lesion']",1,PFIZER\BIONTECH,SYR 1028454,OH,45.0,F,"10 days after second dose awoke at 11:30 at night with nausea then after a few minutes began to itch and break out into hives then proceeded to get chest pressure and unable to breath until I passed out. Husband able to revive me 3 times until 911 came then went to urgent care Nausea with vomiting and chest pain, back pain, heart burn, and urinal incontinence. Sent to MC for NSTEMI work up of echo and cardiac stress test. Cardiologist said NSTEMI from low oxygen and hypotension.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/25/2021,02/06/2021,12.0,WRK,Phentermine 37.5 mg take 1/2 pill daily,None,None,,None,"['Acute myocardial infarction', 'Back pain', 'Cardiac stress test normal', 'Chest X-ray normal', 'Chest discomfort', 'Chest pain', 'Dyspepsia', 'Dyspnoea', 'Echocardiogram normal', 'Electrocardiogram normal', 'Fibrin D dimer increased', 'Full blood count normal', 'Hypotension', 'Hypoxia', 'Laboratory test', 'Loss of consciousness', 'Metabolic function test', 'Nausea', 'Pruritus', 'Sleep disorder', 'Troponin normal', 'Urinary incontinence', 'Urticaria', 'Vomiting']",2,MODERNA,IM 1028476,AR,79.0,F,She started having breathing problems/heart attack appearance. on 1/22/21 and went to the ER. Upon admittance was told it was an anaphylactic shock from the Covid shot. They kept her in ICU and released her 1/23/21. At 12:45 am on 1/24/21 she passed out and we called the ambulance. Hospital admitted her and worked through multiple organ failure issues and thought her numbers were under control. She was released on 1/27/21 and was driving on 1/28/21 around 4:15 pm and appears to have had heart failure and had a wreck. She passed away that day.,Yes,01/28/2021,Not Reported,Yes,6.0,Not Reported,N,01/21/2021,01/22/2021,1.0,PVT,Don't have a list,,"A fib, type 2 diabetes, obesity",,,"['Anaphylactic shock', 'Cardiac failure', 'Death', 'Dyspnoea', 'Intensive care', 'Loss of consciousness', 'Multiple organ dysfunction syndrome', 'Myocardial infarction', 'Road traffic accident']",UNK,PFIZER\BIONTECH, 1028505,WA,81.0,M,"Unclear if related. Patient vaccinated on 1/22 with first dose of Moderna series (reportedly at his work place) and did well. Then on 2/5 had sudden onset headache found to have significant subarachnoid hemorrhage. Admitted to neuro ICU, EVD placed by neurosurgery. Later went on to develop aspiration pneumonia and MSSA bacteremia. Unclear if initial SAH may have been related to mRNA vaccine.",Not Reported,,Yes,Yes,8.0,Not Reported,N,01/22/2021,02/05/2021,14.0,UNK,aspirin 81 mg EC tablet Take 81 mg by mouth Daily. atorvaSTATin (LIPITOR) 80 MG tablet TAKE ONE TABLET BY MOUTH DAILY losartan (COZAAR) 25 mg tablet Take 1 tablet by mouth Daily. Multiple Vitamin TABS Take by mouth Daily.,None,"HTN, HLD, CAD s/p CABG (2014)",,ACEi -> cough,"['Computerised tomogram head abnormal', 'Headache', 'Intensive care', 'Pneumonia aspiration', 'Staphylococcal bacteraemia', 'Subarachnoid haemorrhage', 'Ventricular drainage']",1,MODERNA,SYR 1028508,NJ,72.0,M,"moderately high fever, headache for two days, then three days later (Tuesday morning) Signs of TIA - slurred speech, central vision blurry, word recall difficulty",Not Reported,,Yes,Yes,2.0,Not Reported,U,02/05/2021,02/06/2021,1.0,PVT,"Acyclovar famodine zrtec Multi vitamin d with K2, omega 3 1 gram daily magnesium citrate 200mg 2x daily",,Waldenstrom's Macroglobular Anemia,"Shingrix - strong flu like symptoms, about 5 years ago",,"['Aphasia', 'Blood test', 'Dysarthria', 'Headache', 'Pyrexia', 'Scan', 'Transient ischaemic attack', 'Vision blurred']",2,MODERNA,IM 1028511,NV,85.0,M,My dad got so sick and pass away on 2/11/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/22/2021,6.0,OTH,Aspirin,Enlarged prostate,,,None,"['Death', 'Malaise']",UNK,MODERNA, 1028567,CO,40.0,M,CVA/thrombotic event. R sided weakness and sensory deficit. No preexisting risk factors. Hypercoaguable work up negative. Managed conservatively. Improvement without resolution of symptoms to date.,Not Reported,,Yes,Yes,2.0,Not Reported,N,01/01/2021,02/07/2021,37.0,PVT,None,None,None,,None,"['Atrial septal defect', 'Cerebrovascular accident', 'Echocardiogram abnormal', 'Embolism', 'Hemiparesis', 'Magnetic resonance imaging brain abnormal', 'Sensory loss']",2,PFIZER\BIONTECH,IM 1028596,NC,94.0,F,"*extreme* fatigue. could not awaken for more than few seconds. When briefly awake she was coherent and not confused. slept deeply from 4pm and could not wake to eat or drink. No fever, bp normal, blood oxygen ok. Blood sugar at 11pm was 230. Gave her 15u lantus at 11pm (normally 25u). Was sleeping at 2:30am but had died at next check at 3:30am.",Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/12/2021,2.0,SEN,"insulin, cardizem, aggrenox, potassium, aspirin 81mg, zofran 4mg, trimethoprim, gabapentin, colon health, AREDS, biotin, gas-x, tylenol, vitamin D3",,"diabetes, arthritis, PVC's, macular degeneration, diseased colon, thyroid partially removed",,,"['Blood glucose increased', 'Death', 'Fatigue', 'Hypersomnia', 'Somnolence']",2,MODERNA,SYR 1028597,NY,57.0,M,R thalamic stroke 2 days after 2nd dose of Moderna vaccine with L sided numbness acute in onset,Not Reported,,Not Reported,Yes,,Not Reported,N,02/11/2021,02/13/2021,2.0,PVT,ALLOPURINOL 300 MG OR TABS Aspirin 81 MG Tab BD PEN NEEDLE NANO U/F 32G X 4 MM Miscellaneous citalopram 20 MG Tablet clopidogrel 75 MG Tablet Fenofibrate 120 MG Tablet HUMALOG KWIKPEN 100 UNIT/ML Solution Pen-injector Insulin,none,"HTN, HLD, DM2, CAD s/p PCI (12/2013) on ASA/Plavix, OSA, prior lacunar strokes",,none,"['Cerebrovascular accident', 'Hypoaesthesia', 'Magnetic resonance imaging brain abnormal', 'Thalamic infarction']",UNK,MODERNA, 1028607,,23.0,M,"Fever 24 hours, then recurred approximately 5 days later., prompted ED eval, then two days later prompted IM admission with hepatitis, fever, leukopenia.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/05/2021,02/06/2021,1.0,MIL,,chronic tonsillitis,,,NKDA,"['Hepatitis', 'Leukopenia', 'Pyrexia']",2,MODERNA,IM 1028665,NC,87.0,F,"Mom became so weak that she couldn't stand or walk without falling down. She seemed unable to control her legs and feet and was unable to sit up unassisted. She was admitted to the hospital on February 11, about 36 hours after receiving the vaccine. She had elevated levels of troponin, but all other cardiac tests came back normal. She had no other abnormal test results. Today, February 13, is the first day she has been able to walk a few steps and sit up without assistance.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/09/2021,02/10/2021,1.0,OTH,"Centrum Vitamins, Vyzulta Eye Drops",None,Type 2 Diabetes,,Sulfa,"['Asthenia', 'Balance disorder', 'Blood test', 'Cardiac stress test normal', 'Computerised tomogram', 'Dyskinesia', 'Dysstasia', 'Echocardiogram', 'Echocardiogram normal', 'Electrocardiogram normal', 'Fall', 'Gait disturbance', 'Posture abnormal', 'Troponin increased', 'Ultrasound Doppler', 'Urine analysis']",2,PFIZER\BIONTECH,IM 1028682,ID,23.0,F,"Nausea and fever beginning around 3:00 AM the morning following the shot. Dehydration the next day, culminating to an Addisonian Crisis. I had to go to the hospital, where I received fluids and other treatments from Saturday to Wednesday. I developed more nausea and diarrhea in the hospital the last two days I was there, which were attributed to a stomach bug that had been going around in my home.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,02/05/2021,02/06/2021,1.0,PVT,Hydrocortisone - 10 mg Fludrocortisone - 0.1 mg Keppra - 1500 mg twice daily,Stomach Bug,Addison?s Disease Epilepsy,,Latex Phenegren,"['Adrenocortical insufficiency acute', 'Blood corticotrophin', 'Blood electrolytes', 'Blood phosphorus', 'Blood potassium', 'Blood test', 'Condition aggravated', 'Dehydration', 'Diarrhoea', 'Gastroenteritis viral', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1028697,CA,51.0,F,Rash surrounding where the vaccine was given,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/11/2021,10.0,PVT,Rash on arm surrounding vaccination area,None,"Congenital VSD (2 open heart surgeries),, diabetes, stage 2 liver disease",,"Contrast dye used for cat scans, allergy to cats",['Vaccination site rash'],UNK,MODERNA, 1031031,,72.0,M,"chest pain Narrative: Patient received dose #1 of Pfizer COVID vaccine at vaccination site on 2/7/21 and subsequently presented same-day to Hospital with complaints of chest pain, mild shortness of breath , weakness and headache. He tested +COVID on admission that same day.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/07/2021,,,OTH,,,,,,"['Asthenia', 'COVID-19', 'Chest pain', 'Dyspnoea', 'Headache', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,UN 1031032,,64.0,M,"Narrative: Patient with history of seizures was given his 1st dose of Moderna COVID- 19 vaccine toward the end of a stable dialysis treatment. 15 minutes post immunization, patient experienced hypotension and grand mal seizures. Hypotension resolved with saline administration. Oxygen via NC administered. EMS called due to ongoing seizure activity. Transported to hospital where he was admitted for an undisclosed diagnosis.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/11/2021,02/11/2021,0.0,OTH,,,,,,"['Condition aggravated', 'Generalised tonic-clonic seizure', 'Hypotension']",1,MODERNA,IM 1031033,,57.0,M,Narrative: Patient evaluated for stroke. No bleeding. Maybe ischemia - Further testing results still pending at the time of this initial report,Not Reported,,Not Reported,Yes,,Not Reported,U,02/10/2021,02/11/2021,1.0,OTH,,,,,,['Cerebrovascular accident'],1,MODERNA,IM 1031034,,72.0,M,"body aches, chills",Not Reported,,Not Reported,Yes,,Not Reported,U,01/21/2021,01/29/2021,8.0,OTH,,,,,,"['Chills', 'Pain']",UNK,MODERNA,IM 1031035,,76.0,M,"Hospitalization-planned Narrative: Patient with planned admission to the hospital for COVID testing and quarantine prior to admission to rehabilitation, strengthening, and social services to establish new home health care services after the previous provider discontinued services.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/09/2021,02/11/2021,2.0,OTH,,,,,,"['No adverse event', 'SARS-CoV-2 test']",2,MODERNA,IM 1031036,,60.0,M,"Seizures Narrative: Hospital employee found aphasic & altered gaze, then tonic-clonic seizure witnessed. Employee intubated in internal ED. Employee drank 1/2-1 gallon Vodka, last drink 24 hours prior to onset. Employee has history alcohol-induced seizure.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/05/2021,02/08/2021,3.0,OTH,,,,,,"['Aphasia', 'Apraxia', 'Endotracheal intubation', 'Generalised tonic-clonic seizure', 'Staring']",2,PFIZER\BIONTECH,IM 1031115,,66.0,M,"syncope, c/o itchy throat Narrative: Patient was seen prior to administration of the Moderna COVID-19 vaccination. He has allergies to bees/egg and a h/o anaphylaxis 2/2 receiving an injection of penicillin in the past. Discussed that prior h/o anaphylaxis to PCN injection was not a contraindication to this vaccination, but is a precaution. Discussed risks of receiving the vaccination vs benefits of the vaccine, which patient states ""I already had this discussion with Dr.!"" He has multiple comorbidities which place him at a higher risk for more severe illness from COVID-19. Again received the risk vs benefit discussion. Patient stated understanding and desire to proceed with the vaccination. He will be monitored for at least 30 minutes in area where staff can directly observe him. Patient received the COVID vaccination at 13:00. At 45 minutes later, staff alerted that he was c/o palpitations. Due to confusion and weakness, we were unable to transport him to an examination room. Oxygen, water, and vitals machine were brought to him. He presented with SOB, confusion, lightheadedness. Exam demonstrated acute distress, speaking in staccato sentences. HR in 80s, with lungs CTAB and no stridor - despite increased RR to 20s. Vitals with HR in 70s, SpO2 remained 97% or greater on RA. BP was initially 140/72. A code blue was called and Drs. presented to the area. Patient c/o itchy throat and still p/w confusion/combativeness, loss of orientation, and SOB. No visible swelling noticed. At around 13:58, patient syncopized. HR and SpO2 remained 70-80s and >98% on room air respectively. Pulse remained palpable. At that time, an epipen was administered. Patient woke up. During the entire episode, he was able to recognize a staff member with whom he was previously familiar. EMS arrived, vitals remained stable. EMS transported patient to the ER for further monitoring and f/u. Concern for immediate allergic reaction 2/2 vaccination. After event, patient in need of referral to allergy provider for evaluation prior to consideration of 2nd dosage.",Not Reported,,Yes,Not Reported,,Not Reported,U,02/11/2021,02/11/2021,0.0,OTH,,,,,,"['Asthenia', 'Cardio-respiratory arrest', 'Confusional state', 'Disorientation', 'Dizziness', 'Dysarthria', 'Dyspnoea', 'Emotional distress', 'Palpitations', 'Respiratory distress', 'Respiratory rate increased', 'Speech disorder', 'Syncope', 'Throat irritation']",1,MODERNA,IM 1031120,,57.0,F,"Fever, Diarrhea, 1/20/21 SYMPTOMS BEGAN. ADMITTED TO HOSPITAL & CONTACTED EOH 1/27/21 WITH FEVER, CHILLS,SOB, COUGH., DIARRHEA, BLOOD CLOTS, FLUID AROUND HEART. Narrative: Other Relevant History:",Not Reported,,Yes,Yes,,Not Reported,Y,12/29/2020,01/20/2020,,OTH,,,,,,"['Chills', 'Cough', 'Diarrhoea', 'Dyspnoea', 'Pericardial effusion', 'Pyrexia', 'Thrombosis']",2,PFIZER\BIONTECH,IM 1031176,,75.0,M,"Death Narrative: Patient received Covid vaccine on 2/2/21, person reports his legs were more rigid with some sweating the day of the vaccination with leg rigidity that was slowly improving. No other adverse effects reported for following 7 days. Person states he had vomiting episode earlier this week, person states he had no other symptoms before or after the vomiting episodes. On morning of 2/12/21, person reports patient got up ready for breakfast with no issues. She says he asked for chorizo and oatmeal but she laughed and said don't you mean chorizo and eggs. He said yes. They got him into W/C and he was rolling himself into dining room got stuck in hallway. She says he took several breaths then 3 very deep breaths and passed away. She called 911 they took his VS but he has passed. She told them to leave him along no resuscitation.",Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/12/2021,10.0,OTH,,,,,,"['Death', 'Hyperventilation', 'Muscle rigidity', 'Vomiting']",1,MODERNA,IM 1031189,,58.0,F,"COVID 19 symptoms and a positive test was confirmed on 1/6, employee noted previous exposure to positive family members Narrative: Employee noted exposure to COVID prior to presenting for 1st dose of vaccine on 1/5/21. On 1/6/21 employee reported the onset of symptoms and was tested and was confirmed COVID positive that day. Positive result was reported to employee health on 1/8/21. Employee Health continued to track employees progress and was informed of the need for hospitalization on 1/14/21. Course of hospitalization noted the need for intubation and significant issue with comorbid condition (rheumatoid arthritis). Employee died on 2/9/2021. Unable to confirm a direct connection to Vaccine vs. COVID infection, but felt it should be reported.",Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/06/2021,1.0,OTH,,,,,,"['COVID-19', 'Condition aggravated', 'Death', 'Endotracheal intubation', 'Rheumatoid arthritis', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1032193,IL,83.0,F,"Patient received his first dose of Covid vaccine on Jan. 30, 2021. On Jan 31, 2021 at 6:08 AM, patient noted unresponsive per facility. Code blue was called and 911 dispatched. He expired in the ER.",Yes,01/31/2021,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/31/2021,1.0,OTH,Unknown,Unknown,Diabetes,,,"['Cardio-respiratory arrest', 'Death', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH, 1028765,OR,48.0,M,"Bilateral PE with right heart strain and pulmonary infarct. COVID negative. Symptoms started 2 days after the vaccine progressively worsened. Diagnosed to day - 02/13/2021. Unknown whether this is an adverse event, but no history of coagulopathy or risk factors",Not Reported,,Yes,Yes,1.0,Not Reported,N,02/06/2021,02/08/2021,2.0,PUB,ibuprofen,None,None,,Ampicillin,"['Angiogram', 'Myocardial strain', 'Pulmonary embolism', 'Pulmonary infarction', 'SARS-CoV-2 test negative']",1,MODERNA,IM 1028778,CA,46.0,M,"On December 17, 2020, my husband, received his first BioNTech BNT162b2 COVID-19 vaccination. On Thursday January 7, 2021, he received this second COVID-19 vaccination. The following three days after his second vaccination, he felt fine. The fourth day, on Sunday January 10, my husband felt extremely fatigued. On Monday the 11th and Tuesday the 12th, he worked a full shift but complained of extreme fatigue and extreme chills to the point that his teeth were chattering while on the phone with me. He decided to work through it. When he got home on Monday night, he started vomiting. On Wednesday January 13, he woke up and had swollen eyes. Once again, he felt extremely fatigued, even after a full nights rest. He had the day off but had an early meeting. After his meeting, he was still tired so he went back to sleep. I left to get lunch, and drop off our kids, and upon my return, I found him on the walk in closet floor, face up, having passed away. He felt as cold as ice. The rapid test done after they called the paramedics resulted in a negative COVID-19 test for him.",Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/10/2021,3.0,UNK,Anxiety and depression medication,,Arrhythmia 20 years ago,,,"['Chills', 'Death', 'Eye swelling', 'Fatigue', 'Peripheral coldness', 'SARS-CoV-2 test negative', 'Vomiting']",2,PFIZER\BIONTECH, 1028819,MO,39.0,F,"First trimester miscarriage after receiving both vaccine doses while pregnant. Granada 5, Para 3 at time of vaccine administration. Due date 9/17/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/18/2020,02/03/2021,47.0,PVT,"Wellbutrin, Zyrtec, Benadryl, flexeril, prenatal vitamins.",None,"Anxiety, migraines",,"Latex, PCN, sulfa, reglan, phenergan","['Abortion spontaneous', 'Exposure during pregnancy', 'Foetal heart rate abnormal', 'Human chorionic gonadotropin decreased', 'Ultrasound antenatal screen abnormal']",2,PFIZER\BIONTECH,IM 1028827,NC,23.0,M,pulmonary embolism,Not Reported,,Yes,Yes,2.0,Not Reported,N,02/09/2021,02/13/2021,4.0,MIL,Gabapentin 300mg qhs,recovering from back surgery performed 8 weeks ago,spondylolisthesis psoriasis,,none,"['Computerised tomogram abnormal', 'Fibrin D dimer', 'Pulmonary embolism', 'Pulmonary infarction']",1,PFIZER\BIONTECH,IM 1028831,IL,32.0,F,Ramsey Hunt Syndrome (2nd Dose),Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/06/2021,02/07/2021,1.0,PVT,"Leviteracitam, Amytriptyline, Baclofen, Bumex",,"Chronic: epilepsy, POTS, EDS, Fibromyalgia, GERD",,Marijuana,"['Blood test abnormal', 'Computerised tomogram abnormal', 'Electrocardiogram abnormal', 'Herpes zoster oticus', 'Magnetic resonance imaging abnormal']",2,PFIZER\BIONTECH,IM 1028885,FL,91.0,M,"Patient (now deceased) received 1st dose of Pfizer-BioNTech vaccine around December 21, 2020 and was noticed to be scratching, fatigued, and unresponsive by a family member on December 24, 2020. He received the second dose of the same vaccine around January 22, 2021. Pockmarks and bleeding scratch marks were noted by a family member on the patient's face prior to this second dose. On January 28, 2021 a family member was alerted that the patient was suffering from severe bullous pemphigoid- a skin condition that has never been experienced by the patient, has been reported to be related to COVID-19 viral infection, and to T-cell responses promoted by vaccines. A corticosteroid was given, but did not work. Blisters developed to the point hands had to be dressed.",Yes,02/08/2021,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/24/2020,3.0,SEN,None know,No.,None known.,,None known.,"['Blister', 'Death', 'Fatigue', 'Haemorrhage', 'Pemphigoid', 'Pruritus', 'Scratch', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,SYR 1028906,IA,58.0,F,"My right arm has been extremely painful ever since. To date I have been to 4 Dr's. I have had a MRI, steroid injections, 4 medications. All with no relief. My arm shoots numbess feeling, tingling, tightness from shoulder to fingertips. It is getting worse. I am unable to do my job and household work.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/21/2020,12/22/2020,1.0,PVT,,,,,,"['Hypoaesthesia', 'Injection site pain', 'Joint stiffness', 'Magnetic resonance imaging', 'Muscle tightness', 'Pain in extremity', 'Paraesthesia', 'Ultrasound scan', 'X-ray']",1,PFIZER\BIONTECH,IM 1028921,FL,85.0,M,"Patient had no energy in the first 24 hours and then began a steady decline that started with vomiting after 48 hours, then an inability to swallow and ultimately the patients death on 2/5/21.",Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/28/2021,2.0,OTH,"Carbo-Levodopa, Insulin, Lisinopril, Metorprol","Parkinsons, Type 2 Diabetes","Parkinsons, Type 2 Diabetes",,None,"['Asthenia', 'Death', 'Dysphagia', 'Vomiting']",1,PFIZER\BIONTECH,IM 1028944,AL,21.0,F,I was diagnosed with Bells Palsy one week after getting the covid vaccine. Half of my face is numb and paralyzed.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/02/2021,02/10/2021,8.0,SEN,,None,Type 1 Diabetic,,None,"['Computerised tomogram', 'Facial paralysis', 'Hypoaesthesia', 'Magnetic resonance imaging', 'X-ray']",1,PFIZER\BIONTECH,SYR 1029003,FL,82.0,F,"I video chatted with her Thursday after receiving the vaccine. My mom was in poor health but she was talking in complete sentences and responded appropriately. She was upright in bed and made eye contact. She smiled and denied pain. By Sunday, she was extremely weak and unable to sip water with a straw. Her health had changed dramatically and rapidly. She moaned in pain and was very fatigued. Her condition continued to deteriorate over the week and she stopped talking and was constantly sleeping. They started antibiotics for the oozing cancer lesion and then morphine for pain and end of life care. She passed away on January 22nd which was 15 days post vaccination.",Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/10/2021,3.0,SEN,unknown,,"advanced leukoaraiosis with moderate cerebral atrophy, htn, right breast carcinoma, spinal stenosis",,none,"['Asthenia', 'Death', 'Fatigue', 'Feeding disorder', 'General physical health deterioration', 'Hypersomnia', 'Moaning', 'Pain', 'Speech disorder', 'Unresponsive to stimuli', 'Wound secretion']",UNK,MODERNA,IM 1029024,MD,92.0,F,tongue swelling starting 7 am 2/14 requiring epinephrine and steroids,Not Reported,,Not Reported,Yes,,Not Reported,U,02/13/2021,02/14/2021,1.0,UNK,Home Medications Medication Sig nitroGLYCERIN (NITRODUR) 0.4 MG/HR patch Place 1 patch onto the skin daily. brinzolamide (AZOPT) 1 % ophthalmic suspension Place 1 drop into the left eye 2 times daily. levETIRAcetam (KEPPRA) 250 MG tablet T,no active,Past Medical History: Diagnosis Date ? COPD (chronic obstructive pulmonary disease) (CMS/HCC) ? GERD (gastroesophageal reflux disease) ? Glaucoma of both eyes ? Hypothyroidism ? Macular degeneration of right eye ? Mitral prolapse ? Osteoporosis ? Seizure (CMS/HCC) 11/08,,Allergies Allergen Reactions ? Ciprofloxacin seizures ? Penicillins Ampicillin was OK blisters ? Sulfa Antibiotics unknown,['Swollen tongue'],UNK,PFIZER\BIONTECH, 1029033,MO,73.0,F,"Day of vaccine headache, fatigue, soreness 2nd day 2/13/21 Had issues sleeping and felt uncomfortable. In early a.m. hours, felt dizzy, feeling of sick stomach, and fainted in the bathroom. Paramedics were called by my spouse and they worked with me, then was transported by Ambulance to emergency room where they ran tests and released me the same day. I was told by the doctor that apparently my blood pressure decreased too fast causing me to faint.",Not Reported,,Yes,Yes,1.0,Not Reported,N,02/12/2021,02/13/2021,1.0,PVT,"AmODIPine Besylate 5 mg tab. for Blood Pressure One per day (took one at 6:30 am day of vaccination) Omerprazole 20 mg. 2 per day (took one at 6:30 a,.m. day of vaccination)",None,None,,Erythromycillin Levaquin,"['Abdominal discomfort', 'Blood pressure decreased', 'Blood test', 'Discomfort', 'Dizziness', 'Fatigue', 'Headache', 'Pain', 'Sleep disorder', 'Syncope']",1,MODERNA, 1029068,WI,79.0,M,"Patient was given vaccine the following day he died ,",Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/08/2021,1.0,OTH,,"Mental health, dementia",,,No known,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",1,MODERNA, 1029075,IL,66.0,M,see prior comments. Sudden pro-longed loss of strength,Not Reported,,Not Reported,Yes,3.0,Yes,N,01/15/2021,01/20/2021,5.0,MIL,"Levothyroxine 75mcg M-F; 112mcg-Sat;/150mcg- Sun Sertraline (Zoloft) 150 mg, daily Metoprolol Succinate 50mg- AM +25mg- PM; daily Buspirone 5 mg, twice daily Magnesium Lactate 84mg, twice daily Mexiletine 150 mg, three times daily Aspirin 8","My husband received an LVAD on July 25, 2020, was discharged from inpatient rehab on 10/14/20, and did 8 weeks of in-home PT, OT & ST, then started outpatient rehab on Jan 7, 2021. When he entered rehab on Jan 7 he was able to toddle (with supervision) without the use of his walker. He did very well as outpatient for two weeks, but then started ""de-abiltizing"" (therapists' language). It coincides with having received COVID vaccine #1 (which I mentioned to his doctors). He's became so weak he can no longer support his own weight (or break his magnesium pills in half) and he began using a wheelchair in the house- which he never relied on -since discharge on 10/14. There's no medical reason for his loss of strength. He is doing very well with the heart pump, though he's had a couple of tachycardia episodes in the past 2 months (Dec 10, 2020 & Jan 9, 2021) He is entering in patient rehab.",,,,"['Asthenia', 'Wheelchair user']",1,MODERNA,IM 1029077,SC,90.0,M,Patients wife came in today to get her second Moderna Covid shot. She said that he was in the hospital with COVID and needed to reschedule.,Not Reported,,Not Reported,Yes,,Not Reported,U,01/17/2021,01/24/2021,7.0,PHM,,,,,,['COVID-19'],1,MODERNA,IM 1029092,WA,74.0,M,Patient after vaccine at night he had shortness of breath.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/07/2021,02/08/2021,1.0,OTH,None,None,COPD,,vernon,"['COVID-19', 'Dyspnoea', 'SARS-CoV-2 test positive']",UNK,MODERNA, 1029112,WA,72.0,F,"After vaccine the client got sick, developed breathing problem.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/07/2021,02/08/2021,1.0,OTH,None,,"Depression, bipolar, dementia",,No unknown,"['COVID-19', 'Dyspnoea', 'Illness', 'SARS-CoV-2 test positive']",UNK,MODERNA, 1029129,ID,67.0,F,"About nine days after my first vaccination, I experienced limited mobility and some discomfort with movement with my left shoulder. Since then I have let it rest from activities but I have done range of motion exercises as well as strengthening exercises. I have also taken 400 mg of ibuprofen twice daily for about a week. I stopped the ibuprofen approximately a week later but I?ve continue to do strengthening and stretching exercises of my left shoulder with some improvement. I reported this both to my internal medicine doctor whom I have given you her name of as well as my sports Medicine doctor. They agreed with my regime . I still don?t have full range of motion as well as some pain with certain movements with my left shoulder.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/17/2021,01/25/2021,8.0,PVT,Took 500 mg of Tylenol extra strength 2 hours before the vaccination.,None,None,,None,"['Joint range of motion decreased', 'Mobility decreased', 'Musculoskeletal discomfort', 'Pain']",1,MODERNA,IM 1029139,,81.0,M,"Patient started feeling very dizzy, sick like, and weak starting about 24 hours after getting the vaccine. He was taken by ambulance to the local hospital and treated with fluids I believe. After regaining strength, he went home and was given meclizine for nausea and dizziness. He was told to keep up fluids and rest.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/11/2021,02/12/2021,1.0,PHM,,,,,,"['Asthenia', 'Dizziness', 'Malaise', 'Nausea']",1,MODERNA,IM 1029154,PA,74.0,M,"6 pm 2/10 I started experiencing severe chest pain. I went to the ER for the pain (no cardiac history). They did all the cardiac tests which were negative and administered morphine for the pain (not effective) and then fentanyl which was effective. I was admitted overnight and discharged at 2pm the following day (2/11). The attending cardiologist could find no explanation other than the vaccine. Although I felt fairly good in the morning (the pain had subsided after the fentanyl administration the previous night) I was tired and went to bed when I got home. Almost immediately severe chills started with violent shaking for several hours, followed by vomiting large amounts three or four times. About 7pm when I attempted to get out of bed to use the bathroom, I fell on the floor as I could not support myself. I was unable to get myself up due to extreme muscle weakness. My wife had to call my stepson to come over to help get me back into bed. A couple of hours later I tried to get out of bed very carefully and at that point I was able to stand with no problem. There then were no further symptoms other than headache. The following day (2/12) I felt much better but spent the day in bed. 2/13 I was up much of the day but still felt somewhat weak and tired. 2/14 (today) I am still much better but somewhat tired with slight malaise.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/10/2021,02/10/2021,0.0,PHM,"Myrbetriq 50 mg qd, Crestor 5mg qd, Lexapro 10mg qd, prilosec 20mg,qd, Aspirin 81mg qd",None,"Type II diabetes, diet control, last A1C 5.9, no meds",,None,"['Asthenia', 'Chest X-ray', 'Chest pain', 'Chills', 'Computerised tomogram', 'Echocardiogram', 'Fall', 'Fatigue', 'Headache', 'Malaise', 'Muscular weakness', 'Tremor', 'Vomiting']",1,MODERNA,IM 1029180,MI,76.0,F,Bilateral lung emboli Acute cor pulmonary,Not Reported,,Yes,Yes,4.0,Not Reported,N,01/30/2021,02/08/2021,9.0,PVT,"Synthroid,Prozac, vit b 12, vit D, Tylenol,",,"Diabetes, hypothyroid, urinary incontinence, post cancer treatment",,"Ethanol, losinopril, premarin","['Computerised tomogram', 'Cor pulmonale', 'Cor pulmonale acute', 'Echocardiogram', 'Pulmonary embolism', 'Ultrasound Doppler']",1,PFIZER\BIONTECH,SYR 1029214,OH,90.0,M,"Uncle received vaccine on 2/9/21 at 11:30am. Had acute myocardial infarction on 2/10/21 at 08:30am where he proceeded to fall and fracture hip. Transported to emergency department and treated for AMI. Stabilized and taken for surgery to repair hip fracture. To be discharged on 2/15/21 to rehabilitation facility. Up until this point he was very healthy and active, despite his age, living unassisted at home.",Not Reported,,Yes,Yes,6.0,Yes,N,02/09/2021,02/10/2021,1.0,UNK,,none,Type 2 diabetes,,,"['Acute myocardial infarction', 'Fall', 'Hip fracture', 'Hip surgery']",1,PFIZER\BIONTECH, 1029215,,73.0,M,New onset aflutter RVR with hypotension,Not Reported,,Yes,Yes,,Not Reported,,02/12/2021,02/14/2021,2.0,PVT,,,No afib/flutter history,,,"['Atrial fibrillation', 'Hypotension']",UNK,PFIZER\BIONTECH, 1029239,NJ,69.0,M,"achy upon waking up on 2/13 (approx 7a). At laundromat, started to get clammy, and sweaty. Sat down, and next thing I knew I has fainted (approx 7:45-8a). Police were called, then First Aid Squad. Very pale, sweaty and nauseous (threw up 2x). Went to Hospital. Was evaluated in the ED for approx 6 hrs, then transferred to a room for overnight observation.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/12/2021,02/13/2021,1.0,SCH,Simvastatin: 20mg once a day; Hydrochlorothiazide: 12.5mg once a day; Losartan: 100mg once a day; Pentoxifylline: 400mg twice a day,none,"high blood pressure, high cholesterol",,"Codeine (and any derivative or ""cousin"" to codeine), penicillan, darvon, demerol","['Chest X-ray normal', 'Cold sweat', 'Computerised tomogram head normal', 'Echocardiogram normal', 'Hyperhidrosis', 'Nausea', 'Pain', 'Pallor', 'Syncope', 'Ultrasound Doppler', 'Ultrasound scan normal', 'X-ray limb normal', 'X-ray normal']",2,MODERNA,SYR 1029289,MN,80.0,M,Patient with achiness that eventually progressed to severe muscle pain with movement and experienced elevation of CK to 6546 on 2/14 and required hospitalization.,Not Reported,,Not Reported,Yes,,Not Reported,N,02/11/2021,02/12/2021,1.0,PVT,"alogliptin, empagliflozin, finasteride, glargine insulin, losartan, metformin, pioglitazone, Tamsulosin, insulin aspart, acetaminophen",Mild achiness in arm after first COVID vaccine,,,lisinopril,"['Blood creatine phosphokinase increased', 'C-reactive protein increased', 'Myalgia', 'Pain']",UNK,MODERNA, 1029322,IA,83.0,F,contracted pneumonia 2 days after receiving vaccination,Not Reported,,Not Reported,Yes,,Not Reported,N,02/10/2021,02/13/2021,3.0,PVT,,none,"back pain, have had several pneumonia's in the past",,"prenizone, gabupentin, sulfa, phenegrin","['Blood test', 'Pneumonia', 'X-ray']",UNK,MODERNA, 1029335,IA,77.0,M,Cardiopulmonary arrest,Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/14/2021,5.0,PVT,Eplerenone Amiloride KCl Entresto Metolazone Bumex Tamsulosin ASA Docusate prn,none,Coronary Artery disease with 2 stents Congestive Heart Failure Hyperaldosteronism History of Pulmonary embolus HTN Hyperlipidemia,,NKDA,['Cardio-respiratory arrest'],1,MODERNA,IM 1029374,CA,81.0,M,"On 2/4/21, at around 3:00pm he began feeling very tired and he began burping in the evening. The following morning, he woke up early and was still burping and not feeling well. At around 5:00am, he collapsed. My mother called 9-1-1 and began giving CPR. The parademics arrived and tried to revive him, and transported him to the hospital but at 6:11am, he was pronounced dead of a heart attack. He was healthy.",Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,01/31/2021,02/04/2021,4.0,OTH,none,none,none,,none,"['Death', 'Eructation', 'Fatigue', 'Malaise', 'Myocardial infarction', 'Resuscitation', 'Syncope']",1,PFIZER\BIONTECH, 1029395,MA,75.0,M,Sudden loss of consciousness while driving motor vehicle. Transport by ambulance to emergency room. Hospitalized for 36 hours and released.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/30/2021,02/07/2021,8.0,OTH,Amlodipine Besylate 10MG 1/day Spironolactone 25MG 1/day Gabapentin 100MG 1/day Glucosamine 1500MG Multivitamin,,high blood pressure,,,"['Echocardiogram', 'Electrocardiogram', 'Full blood count', 'Loss of consciousness', 'Urine analysis']",1,MODERNA,IM 1029412,NY,69.0,M,Death,Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/04/2021,2.0,PHM,,None,None,,none,['Death'],1,MODERNA,IM 1029460,MA,79.0,F,Patient started to experience chest tightness and then hypertension,Not Reported,,Not Reported,Yes,,Not Reported,U,02/13/2021,02/13/2021,0.0,PVT,atenolol atorvastatin diazepam keppra levothyroxine lisinopril omeprazole multivitamin prednisone,none,HTN seizures diabetes hypothyroidism polymyalgia rheumatica,,aspirin bupvicaine azithromycin clindamycin codiene epinephrine fentanyl levoquin lidocaine metformin morphone penicillin,"['Blood sodium increased', 'Chest discomfort', 'Condition aggravated', 'Electrocardiogram ST segment depression', 'Hypertension']",1,PFIZER\BIONTECH,IM 1029511,VA,80.0,M,Developed severe shortness of breath.,Yes,02/08/2021,Not Reported,Yes,2.0,Not Reported,N,01/21/2021,01/24/2021,3.0,PUB,Tylenol 500mg as needed Zyrtec 10mg daily Lysine 500mg daily Nyquil/Dayquil as needed Pepcid 20mg at bedtime,None,"None, never sick",,None,['Dyspnoea'],1,MODERNA,SYR 1029514,NC,71.0,M,patient deceased,Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,02/09/2021,34.0,PUB,unknown,acid reflux,acid reflux,,n\a,['Death'],UNK,MODERNA,IM 1029529,MN,65.0,M,I saw the patient in consultation during his hospitalization for pancytopenia which proved to be severe aplastic anemia after bone marrow biopsy. He has been a blood donor. 1/4 Moderna vaccine HGB 1/8 12.8 - blood bank refused him to be a donor due to the HGB being too low. Recommended to repeat CBC at his primary care office. 1/26 7.8 1/29 7.1 1/30 5.7 No reticulocytes,Not Reported,,Yes,Yes,10.0,Not Reported,N,01/04/2021,01/08/2021,4.0,PVT,celexa requip x yeasrs both of them,restless leg syndrome anger management,as above,,NKDA,"['Aplastic anaemia', 'Biopsy bone marrow abnormal', 'Chromosome analysis normal', 'Cytogenetic analysis normal', 'Cytomegalovirus test negative', 'Epstein-Barr virus test negative', 'Granulocytopenia', 'Haemoglobin decreased', 'Karyotype analysis normal', 'Neutrophil count decreased', 'Normocytic anaemia', 'Pancytopenia', 'Paroxysmal nocturnal haemoglobinuria', 'Parvovirus B19 test negative', 'Platelet count decreased', 'Thrombocytopenia', 'White blood cell count decreased']",UNK,MODERNA, 1029537,TX,71.0,F,Appendicitis resulting in laproscopic appendectomy 2/10/2021,Not Reported,,Yes,Not Reported,,Not Reported,Y,02/05/2021,02/10/2021,5.0,OTH,,None,None,,,"['Appendicectomy', 'Appendicitis', 'Computerised tomogram', 'Full blood count', 'Laparoscopic surgery', 'Metabolic function test', 'Scan with contrast', 'Urine analysis']",1,PFIZER\BIONTECH,IM 1029554,GA,66.0,M,Patient died suddenly on 2/1/21 from unknown causes according to his son.,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,01/17/2021,02/01/2021,15.0,PHM,Unknown,Unknown,Unknown,,None,['Sudden death'],1,MODERNA,IM 1029599,,71.0,M,"Admitted 4 days after moderna #2 with Rhabdo. Could be related to vaccine. Could also be related to a fall at home and patient found down. Suspect the latter, though patient is convinced it is directly related to severe myalgias due to COVID vaccination.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/10/2021,02/13/2021,3.0,PVT,"ASA, synthroid, losartan, oxycodone, lyrica, sertraline",,"Chronic Pain on 400 morphine mg equivalents per day. PTSD, COPD, Hypothyroidism, Hx of Nissen, Systolic Murmur",,"statins, sulfas","['Blood creatine phosphokinase increased', 'Fall', 'Hepatic enzyme increased', 'Myalgia', 'Rhabdomyolysis']",2,MODERNA,IM 1029607,FL,65.0,F,"Three hours after vaccination, numbness in tongue, unable to recall common words during conversation. Numbness in both hands, Confusion, lightheaded but not dizzy.",Not Reported,,Yes,Yes,1.0,Not Reported,U,02/11/2021,02/11/2021,0.0,UNK,"Synthroid .77mcg, Lipitor 20mg, lexapro 10mg ,ubrelvy 50 mg as needed ,ambient 5mg, zertec daily",,"Hypothroid, gastrophoresis, migraines ,high cholesterol",,,"['Communication disorder', 'Computerised tomogram head', 'Confusional state', 'Dizziness', 'Echocardiogram', 'Electrocardiogram', 'Full blood count', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Magnetic resonance imaging brain', 'Ultrasound Doppler', 'Urine analysis']",2,MODERNA,IM 1029610,GA,88.0,F,Right sided weakness and right facial droop,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/11/2021,02/13/2021,2.0,MIL,"Amlodipine, pantoprazole, atorvastatin, ASA, lisinopril, ca/vit D, metformin",,"CVA, TIA, DM2, HTN, HLD",,Codeine,"['Facial paralysis', 'Hemiparesis']",UNK,MODERNA,IM 1029667,NH,75.0,M,"About 10 hours after vaccine, started experiencing very severe lower back pain, and the piriformis syndrome became worst ever had. Pain so severe, cannot walk.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/11/2021,02/12/2021,1.0,OTH,pravastatin; valsartan; centrum silver vitamin; 80 mg aspirin,Minor lower back arthritis; moderate piriformis syndrome,none,,none known,"['Back pain', 'Condition aggravated', 'Gait inability', 'Pain', 'Piriformis syndrome']",1,MODERNA,IM 1029683,CT,27.0,F,"Anaphylaxis. Hives, anterior/posterior throat swelling, shortness of breath. Resolved with epinephrine drip, receiving three epinephrine injections and Benadryl from EMS. Likely will be kept for observation given epi drip.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/14/2021,02/14/2021,0.0,PUB,None.,none.,Overweight.,,NKDA,"['Anaphylactic reaction', 'Dyspnoea', 'Pharyngeal swelling', 'Urticaria']",1,PFIZER\BIONTECH,IM 1029737,MD,46.0,F,"Episodes of tachycardia on multiple occasions. Last on 2/11/2021, hospitalized overnight for observation",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/25/2021,01/31/2021,6.0,WRK,"Melatonin, IUD",None,None,,None,"['Chest X-ray', 'Echocardiogram', 'Tachycardia', 'Troponin']",1,MODERNA,SYR 1029744,OK,93.0,M,"right arm swelling immediately after injection. followed by bilateral lower leg edema, chills and body aches that continued daily at 2 weeks post immunization admin 2/4/21 treated with dexamethasone 6mg PO x 7 days- this resolved his s/s 2/13/21 patient passed away at facility",Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/18/2021,0.0,SEN,"tamsulosin, simvastatin, aspirin, doxazosin, colace, loratadine, vitamin b12, senna, vitamin b complex, omeprazole, alendronate, vitamin d3, calcium",none,"hyperlipidemia, hypertension, digenerative disc disease, BPH, osteoporosis, skin cancers- removed, constipation, allergic rhinitis",,chlorpheniramine,"['Cardiomegaly', 'Chest X-ray abnormal', 'Chills', 'Death', 'Eosinophil count increased', 'Full blood count', 'Immediate post-injection reaction', 'Metabolic function test normal', 'Oedema peripheral', 'Pain', 'Peripheral swelling', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 1029770,CT,55.0,F,Rash over entire body,Not Reported,,Not Reported,Not Reported,,Yes,N,01/06/2021,01/09/2021,3.0,UNK,None,None,None,,Nonenone,['Rash'],1,MODERNA,SYR 1029784,MT,75.0,F,"Patient presented on 1/24 with acute onset weakness and numbness of the left leg so a stroke alert was activated. NIHSS 3. Head Ct and CTA head/neck were unremarkable. Not a candidate for tPA given on Eliquis. Initial exam was notable for weakness and sensory loss in the left leg, but a sensory level was also found to the umbilicus raising concern for a myelitis. Of note, the patient also reported that certain red colored things she looked at appeared black. Labs unrevealing- CBC, CMP unremarkable. ESR, CRP normal. UA and UCx positive for E. Coli UTI, she was treated with ceftriaxone. MRIs were done of her brain, cervical and thoracic spine which were unrevealing. On 1/25, her exam worsened including worsening weakness in the left leg and new numbness and paresthesias in the right leg. Reflexes were preserved. MRI L spine was done which was unrevealing. Lumbar puncture was done which showed 2 nucleated cells and mildly elevated protein at 50, but was otherwise unrevealing. IgG Index normal. No oligoclonal bands. She developed mild hyperreflexia in the left leg and continued to have a sensory level, now at around T5-6. Repeat imaging of her cervical and thoracic spine were completed on 1/28 which showed a contrast enhancing hyperintensity at T5. The patient was diagnosed with myelitis and she was started on IV methylprednisolone x5 days and sent to rehab. Patient is now significantly improved though continues to report some numbness in the left leg.",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,01/23/2021,01/24/2021,1.0,PVT,"albuterol, apixaban, cleocin topical gel, diclofenac, diprolene ointment, estradiol, fluorometholone, lipitor, losartan, multivitamin, prilosec, tretinoin topical, valacyclovir, vitamin D3",None,"hypertension, hyperlipidemia, degenerative disk disease, spinal stenosis, irritable bowel syndrome, osteoarthritis, DVT/PE, corneal transplant vitamin D deficiency",,timolol (burning),"['Angiogram cerebral normal', 'Arteriogram carotid normal', 'Blood immunoglobulin G normal', 'C-reactive protein normal', 'CSF protein increased', 'Computerised tomogram head normal', 'Culture urine positive', 'Escherichia urinary tract infection', 'Full blood count normal', 'Hyperreflexia', 'Hypoaesthesia', 'Lumbar puncture abnormal', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging spinal abnormal', 'Metabolic function test', 'Metabolic function test normal', 'Muscular weakness', 'Myelitis', 'NIH stroke scale abnormal', 'Paraesthesia', 'Protein total increased', 'Red blood cell sedimentation rate normal', 'Sensory level abnormal', 'Sensory loss', 'Urinary tract infection', 'Urine analysis abnormal', 'Visual impairment']",1,PFIZER\BIONTECH,IM 1029790,CA,95.0,F,Taken to Emergency about 8 hours later and died in ER,Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,SEN,"Escitalophram Over the Counter - B12, Iron, Calcium, Senna",Dementia,"Anemia, Osteoporosis,",,None,['Death'],2,PFIZER\BIONTECH,SYR 1029801,CA,34.0,M,"01/31/21 approx 12 hours after receiving the second dose of Moderna vaccine I experienced blurred vision to right eye. Upon further eval I confirmed 30% loss of vision to right eye. No other symptoms noted. To date no change in symptoms. Since onset of symptoms I have been evaluated by various providers. 02/03 MD, 02/04 MD, 02/04 emergency room intake with blood work and MRI at hospital, 02/12 MD.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/30/2021,01/31/2021,1.0,WRK,Mesalamine 1.2 Gm x2 daily PO,Ulcerative colitis exacerbation from November through December 2020.,"Ulcerative Colitis, chronic, >10 years",,"Pediazol, Ceclor","['Blood test', 'Magnetic resonance imaging', 'Vision blurred', 'Visual impairment']",UNK,MODERNA,IM 1029814,AK,82.0,F,"Systolic bp's in the 180-200;s HR in 60's Ox sat in the 70, RR of 30 labored.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/14/2021,1.0,SEN,Sinemet Coreg Lexapro miralax oxycontin Vitamin C Centrum silver Ferrous sulfate gabapentin megace seroquel senna-docusate,,Parkinsons visual hallucinations abnormal visual perceptions osteoarthrites of both knees afib pacemaker re-curring UTI's Acid refulx Sundowns charles-bonnet syndrome Bleeding after menopause,"Covid-19 Pfizer, 12/29/20, Red painful, swollen deltoid that radiated to her hand.",codeine bactrim,"['Blood pressure systolic', 'Dyspnoea']",2,PFIZER\BIONTECH,IM 1029822,OH,37.0,F,"This is a 37 y.o. woman who developed an episode of acute self-limited hemolysis just over a week following her second injection of the Pfizer COVID-19 vaccine. She has been treated with ciprofloxacin and phenazopyridine immediately prior to the episode for a urinary tract infection. She had no history of hemolysis prior to this episode. She was in her usual state of health and received COVID-19 vaccines on 12/24 and 1/14 with the Pfizer vaccine and had no serious side effects at that time. She then developed dysuria and was seen by telehleath by her primary care physician who prescribed ciprofloxacin and phenazopyridine for her for 3 days ending 1/22. She took these and her dysuria resolved, however the day after developed what appeared to be blood in her urine. Then in the following 2 days which were a weekend this worsened and she started feeling poorly. She also noted that she appeared yellow. On Monday 1/25 her boyfriend took her to urgent care and she was subsequently sent to an ER at the hospital that referred her to our hospital. There she was evaluated for gross hematuria with no evidence of urinary bleeding and found to be anemic due to hemolysis. Her hemoglobin was in the 5's and she received 2 units of PRBCs. She was transferred here to Medical Center for further management. After the initial transfusion she did not require blood transfusion and her hemoglobin continued to increase until it was 10.4 on 2/1 which was the day of discharge. At a follow up appointment on 2/8/2021 she was recovering and feeling well. Her jaundice had resolved. No treatment was given from the hemolysis aside from the blood transfusion and it was self-limited. It is most likely that her acute hemolysis was due to the phenazopyridine as this agent is known to cause hemolysis and she took it for 3 days prior to the onset of hemolysis. She has no prior history of drug induced hemolysis and had not taken this medication previously. As this occurred just over a week following her second vaccination I cannot exclude that is could be related to the vaccine.",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,01/14/2021,01/22/2021,8.0,PHM,Bupropion XL 150 mg PO daily escitalopram 20 mg PO QHS Fexofenadine 180 mg PO daily Montelukast 10 mg PO QHS Multiple Vitamin 1 tablet PO daily Norethin Ace-Eth Estrad-FE (BLISOVI FE 1.5/30 PO) 1 PO daily,None.,Depression.,,None.,"['Anaemia', 'Blood folate normal', 'Blood iron normal', 'Blood smear test normal', 'Blood urine present', 'Coombs direct test', 'Dysuria', 'Feeling abnormal', 'Flow cytometry', 'Glucose-6-phosphate dehydrogenase abnormal', 'Haematuria', 'Haemoglobin decreased', 'Haemolysis', 'Jaundice', 'Packed red blood cell transfusion', 'Paroxysmal nocturnal haemoglobinuria', 'Transfusion', 'Urinary tract infection', 'Vitamin B12 normal', 'Yellow skin']",2,PFIZER\BIONTECH,IM 1029842,MP,72.0,M,Patient at primary care provider's office on 2/13/21 for workup before planned intervention for PVD. Lab results from 2/12 blood draw showed platelets=15k. Unexpected thrombocytopenia. Patient had NOT had URTI/cold/flu symptoms. No bleeding. No blood in stool. No tarry-black stools. No fever or chills. No headache. Provider sent patient immediately to the emergency room for a repeat CBC. Platelets=3k (1 day after the result of 15k). Patient admitted to hospital. Hematologist consulted. Dexamethasone 40 mg po q day prescribed (to take 2/13-2/17). Discharged from hospital 2/15 as platelets had risen to 21k. Expected follow up with hematologist (Dr.) within a few days.,Not Reported,,Yes,Yes,3.0,Not Reported,U,01/13/2021,02/12/2021,30.0,PVT,Levimir 50 units AM & PM; Novolog sliding scale; Aspirin (dose/frequency not specified); Lisinopril q day (dose unknown); Some additional meds but patient does not know names or doses,none,"insulin dependent diabetes mellitus, 50-year smoking history (quit 2 years ago), hypertension, lower extremity peripheral vascular disease",,no known allergies,"['Activated partial thromboplastin time shortened', 'Full blood count', 'HIV test', 'Hepatitis B surface antigen', 'Hepatitis C virus test', 'International normalised ratio increased', 'Peripheral vascular disorder', 'Platelet count increased', 'Prothrombin time shortened', 'Thrombocytopenia']",2,PFIZER\BIONTECH,IM 1029994,AL,33.0,F,"Won't let me type everything. Long story short. Face tingled for a few days after shot, forehead skin got tight and dry, now I've lost vision in my right eye! Today is exactly 2 weeks after 1st vaccine and sight in my right eye is worse and painful",Not Reported,,Not Reported,Not Reported,,Yes,N,02/01/2021,02/01/2021,0.0,PUB,birth control,seasonal allergies maybe,,,,"['Blindness unilateral', 'Condition aggravated', 'Dry skin', 'Eye inflammation', 'Eye pain', 'Ophthalmological examination abnormal', 'Paraesthesia', 'Skin tightness']",1,PFIZER\BIONTECH,IM 1030008,,50.0,U,"They are only 30% effective; I have been ""overdosed"" with the PREVNAR and PNUEMOVAX shots. I am 68 and have been getting then since I was 50; I have been ""overdosed"" with the PREVNAR and PNUEMOVAX shots. I am 68 and have been getting then since I was 50; Pneumonia; This spontaneous report was received from a 68-year-old patient of an unknown gender concerning to themself via Pfizer. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications were not provided. On an unknown date, since the patient was 50-year-old, the patient had been getting vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported) and with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) (indication, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported) (inappropriate schedule of product administration). The patient was certain the she had been ""overdosed"" with the vaccines shots(overdose). In January 2021 (reported as last January), she got pneumonia and went to the urgent care, where, the patient explained to the physician she was diligent with the vaccines and the physician stated that vaccines were only 30 percent effective (therapy partial responder). The outcome of pneumonia and therapy partial responder was unknown. The causal assessment between the events and the suspect vaccines were not reported. Upon internal review, pneumonia had been considered a medically significant event.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/01/2021,,UNK,,,,,,"['Pneumonia', 'Therapy partial responder']",UNK,MERCK & CO. INC., 1030009,,11.0,F,"patient passed out; patient became stiff; This spontaneous report was received from a nurse via company representative regardin a 11-year-old female patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 09-FEB-2021, the patient was vaccinate with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and other dose of meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) in the opposite arm (dose, route, anatomical location, lot number and expiration date were not reported for both vaccines); all for prophylaxis. On the same day immediately after received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient became stiff and passed out (stiffness and loss of consciousness). The patient was monitored in the office for about 30 minutes and then released home. The did not seek medical attention and no treatment was given for the events. At the time of the report, the patient had recovered from the events on 09-FEB-2021. The relatedness between the events of stiffness and loss of consciousness and therapy with received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported. Upon internal review, loss of consciousness was determined to be medically significant event.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,UNK,,Prophylaxis,,,,"['Immediate post-injection reaction', 'Loss of consciousness', 'Musculoskeletal stiffness']",UNK,SANOFI PASTEUR, 1030011,,,U,"taking Eliquis who died after receiving the Pfizer-BioNtech Covid-l9; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-014171), license party for apixaban (ELIQUIS). This spontaneous case was reported by a non-health professional and describes the occurrence of DEATH (taking Eliquis who died after receiving the Pfizer-BioNtech Covid-l9) in patient of an unknown age and gender who received apixaban (Eliquis) for an unknown indication. CO-SUSPECT PRODUCTS included Covid-19 Vaccine. On an unknown date, the patient started Eliquis (unknown route) and Covid-19 Vaccine (unknown route). DEATH occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. The doctor died after taking Eliquis with Covid-19 Vaccine. For Eliquis(Unknown), the reporter did not provide any causality assessments. This case was linked to US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-012621 (Linked Report).; Sender's Comments: BMS Medical Evaluation Comment: This patient died after receiving apixaban therapy. Patient also received COVID-19 vaccine. Based on the limited information available regarding the cause of death and autopsy details, it cannot be ascertained with the reasonable possibility that the apixaban could have caused the event.; Reported Cause(s) of Death: Unknown cause of death",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,ELIQUIS,,,,,['Death'],UNK,PFIZER\BIONTECH, 1030014,NJ,,M,"Upper frequency hearing loss; Ringing in my ears; Really tired; Little bit spaced out; A spontaneous report was received from a consumer concerning a 75-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced ""ringing in my ears"", upper frequency hearing loss, really tired and little bit spaced out. The patient's medical history was not provided. Concomitant medication included Clopidogrel bisulfate, Bromelain, Pantoprazole sodium, Atorvastatin, low dose aspirin and Vitamin C. On 28 Jan 2021, approximately 2-3 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient reported that after the injection he noticed ringing in his ears with upper frequency hearing loss. He felt tired and a little bit spaced out. Treatment information was not provided. On 29 Jan 2021, the patient reported ringing was a little better, but the upper frequency hearing loss was still there along with feeling spaced out. Action taken with mRNA-1273 in response to the events was not provided. On 29 Jan 2021, the patient was recovered from really tired. The outcome of the events ""ringing in my ears"", upper frequency hearing loss, and little bit spaced out was unknown.; Reporter's Comments: This case concerns a 75-year-old, male, who experienced serious unexpected event of deafness, non-serious unexpected event of tinnitus, feeling abnormal and, non-serious expected event of fatigue. The events occurred 1 days (2-3 hrs) after mRNA-1273 (Lot# Unknown). Concomitant medications included Clopidogrel bisulfate, Bromelain, Pantoprazole sodium, Atorvastatin, low dose aspirin and Vitamin C. Treatment details were not provided. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,PLAVIX; BROMELAIN; PANTOPRAZOLE SODIUM; ATORVASTATIN; ASPIRIN 81; VITAMIN C ACID,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Deafness', 'Fatigue', 'Feeling abnormal', 'Tinnitus']",1,MODERNA,OT 1030015,MA,31.0,F,"Cellulitis; A spontaneous report (United States) was received from a consumer regarding a 31 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced cellulitis. The patient's medical history was not provided. Concomitant medication use was not provided. On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 19 Jan 2021 the patient experienced cellulitis. Treatment for the event included intravenous antibiotics. Action taken with mRNA-1273 in response to the event was not provided. The outcome for the event , cellulitis, was considered unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,01/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Cellulitis'],1,MODERNA,OT 1030016,AR,,M,"Faint; Shortness of breath; Dizzy; Headache; A spontaneous report was received from a consumer who is a 34-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fainting, dizziness, shortness of breath and headache. The patient's medical history was not provided. Concomitant medications were not reported. On 30 Jan 2021, the patient received their second dose of two planned doses of mRNA-1273 (Batch number: 029L20A) intramuscularly in his right arm for the prophylaxis of COVID-19 infection. On 31 Jan 2021, 14 hours after the second dose, the patient experienced fainting, dizziness, shortness of breath and headache. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, fainting, dizziness, shortness of breath and headache, were unknown.; Reporter's Comments: This case concerns a 34-year-old male patient, who experienced medically significant unlisted event of Syncope, non-serious listed event of Headache, and non-serious unlisted events of Dyspnea and Dizziness. The events occurred approximately 14 hours after receiving their second of two planned doses of mRNA-1273 (Lot #029L20A). Based on the current available information and temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,01/31/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Dizziness', 'Dyspnoea', 'Headache', 'Syncope']",2,MODERNA,OT 1030017,IL,73.0,M,"Pneumonia; COVID-19; Fever of 100.4; A spontaneous report was received from a health care professional concerning a 73-year-old, male, patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fever, pneumonia, and COVID-19. The patient's medical history, as provided by the reporter, included a previous COVID-19 infection diagnosis. Concomitant medications were not reported. On 29 Dec 2020, the patient received their first dose of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection. On 30 Dec 2020, the patient experienced fever of 100.4 and was given paracetamol. On 31 Dec 2020, the patient had a chest x-ray and was admitted to the hospital for pneumonia. On 03 Jan 2021 the patient tested positive for COVID-19. The patient had previously tested positive for COVID-19 in November. No additional treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, fever, pneumonia, and COVID-19, was unknown.; Reporter's Comments: This case concerns a 73-year-old, male patient, with a previous COVID-19 infection prior to vaccination, who experienced a serious event of Pneumonia and non-serious events of Covid-19, and Pyrexia after receiving first dose of mRNA-1273 (Lot# 039K20A). Based on the mechanism of action of mRNA-1273, the event of Covid-19 is assessed as unlikely related to mRNA-1273. Very limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,12/29/2020,12/30/2020,1.0,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['COVID-19', 'Chest X-ray', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test']",1,MODERNA,OT 1030018,MA,20.0,M,"Myocarditis; Acute onset of chest pain; Soreness of the arm; A spontaneous report was received from a physician concerning a 20-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness of the arm, acute onset of chest pain, and myocarditis. The patient's medical history, as provided by the reporter, included asthma, and allergy to egg, peanut and tree nuts. Concomitant medications reported included dupilumab, montelukast, budesonide / formoterol, cetirizine, albuterol and epinephrine. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 26 Jan 2021, after receiving the second dose of the vaccine, the patient reported soreness of the arm for 3 to 4 days. On 30 Jan 2021, the patient presented to the hospital with acute onset of left sided chest pain. The physician reported that the patient developed myocarditis. Consent for Safety to follow up was received. Treatment for the events, as reported, included patient's concomitant medications of dupilumab, montelukast, budesonide / formoterol, cetirizine and albuterol. No additional treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The event, soreness of the arm, was resolved on unknown date. The event acute onset of chest pain and myocarditis was not resolved at the time of this report.; Reporter's Comments: This case concerns a 20 year old male with medical history of multiple allergies, who was hospitalized with serious unexpected events of chest pain and myocarditis and a non-serious unexpected event of pain in extremity. The chest pain and myocarditis occurred 33 days after first dose and 4 days after last dose of mRNA-1273. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/29/2020,01/26/2021,28.0,UNK,DUPIXENT; SINGULAIR; SYMBICORT; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ALBUTEROL [SALBUTAMOL]; Epi-pen,Allergy to nuts (Tree nuts); Asthma; Egg allergy; Peanut allergy,,,,"['Chest pain', 'Myocarditis', 'Pain in extremity']",1,MODERNA,OT 1030019,PA,67.0,F,"feeling much worse; Bloodwork with elevated parameters (troponins); Couldn't take food; Couldn't get up from bed; Fever (101�F); Atrial fibrillation; Pericarditis; A spontaneous report was received from a non-healthcare professional concerning a 67-year-old, female patient who developed a fever of 101 degrees Fahrenheit, feeling much worse, couldn't take food, couldn't get up from bed, bloodwork with elevated troponin, pericarditis, and atrial fibrillation. The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the event, included Pentasa, metformin, insulin, Zoloft and atorvastatin. The patient received their first of two planned doses of mRNA-1273 (lot number 028L20A) on 20 Jan 2021 in the right arm for prophylaxis of COVID-19 infection. The patient developed a fever on 25 Jan 2021, and it got up to 101 degrees Fahrenheit on 26 Jan 2021. On 26 Jan 2021 she felt must worse, couldn't take food, and couldn't get up from bed. On 27 Jan 2021, she was taken to the emergency room where her oxygen saturation was low, but the fever was gone. She was placed on oxygen, and blood work had elevated troponin. The patient was diagnosed with pericarditis and she was kept overnight. On 28 Jan 2021 she had atrial fibrillation and the medical team couldn't convert her chemically. She was stabilized on 30 Jan 2021 and she was feeling much better. Treatments of these events included oxygen and ibuprofen. The events, fever of 101 degrees Fahrenheit, feeling much worse, couldn't take food, couldn't get up from bed, bloodwork with elevated troponin, pericarditis, and atrial fibrillation were considered Recovering.; Reporter's Comments: This case concerns a 67 year old female who experienced serious unexpected events of feeling abnormal, decreased appetite, bedridden, elevated troponin, pericarditis, and atrial fibrillation, and a serious expected event of fever. The events began 6 days after first dose of mRNA-1273. Treatment with ibuprofen. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Yes,Yes,,Yes,N,01/20/2021,01/25/2021,5.0,UNK,PENTASA; METFORMIN; ZOLOFT; ATORVASTATIN,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Atrial fibrillation', 'Bedridden', 'Body temperature increased', 'Decreased appetite', 'Feeling abnormal', 'Oxygen saturation decreased', 'Pericarditis', 'Pyrexia', 'Troponin']",1,MODERNA, 1030020,,73.0,F,"sixth nerve palsy of the right eye; A spontaneous report was received from a healthcare professional concerning a 73-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed sixth nerve palsy of the right eye. The patient's medical history was not provided. Concomitant product use was not provided. On an unknown date, approximately two weeks prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 01 FEB 2021, she was seen at an ophthalmologist office and diagnosed with sixth nerve palsy of the right eye. An MRI was performed on an unknown date for the patient's condition which revealed there was mild generalized cerebral atrophy, prominent enlargement of the lateral and 3rd ventricles out of proportion to degree of cerebral atrophy. 4th ventricle is non dilated. There is patchy bilateral cerebral white matter flares. Hyperintensity is noted likely representing findings of chronic microvascular ischemic change. No obstructive lesion identified. No contiguous band of flare/T2 hyperintensity along the surface of the ventricles to suggest the presence of transependymal CSF flow. Impression was that in the setting of potential 6th nerve palsy, this constellation of findings may potentially represent underlying increased intracranial pressure. Normal pressure hydrocephalus was an alternative consideration in the appropriate clinical context. No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, developed sixth nerve palsy of the right eye, was not reported.; Reporter's Comments: This case concerns a 73 year old, female patient who experienced a serious event of Ophthalmoplegia after receiving second dose of mRNA-1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,02/01/2021,31.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Magnetic resonance imaging', 'Ophthalmoplegia']",1,MODERNA,OT 1030021,TX,,M,"Diabetic Ketoacidosis (nausea, heavy breath, could not form words, PH dropping); Increase of resting heart rate 114 to 120 to 130 and max 150; Terrible Migraine; Extreme nausea; A spontaneous report was received from a consumer, concerning her son, who is 27-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced diabetic ketoacidosis (DKA), terrible migraine, nausea, heavy breathing and increased heart rate. The patient's medical history, as provided by the reporter, included Asperger syndrome and Diabetes. No concomitant products were reported. On 14 Jan 2021, one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection. On 15 Jan 2021, at 10:30 AM, the patient had terrible migraine and extreme nausea. He experienced DKA as he could hardly breath and breathing was heavy. At 6 PM, as stated by the reporter, the patient went to the emergency room and tests were done which confirmed DKA. The patient stayed there for 2 hours but his PH level was decreasing, couldn't form words and heart rate was 150 beats per minute(bpm) and was transferred to bigger hospital where he stayed in ICU. He was discharged in the afternoon on 17 Jan 2021. On 20 Jan 2021, the reporter stated that the patient again went back into DKA and was sent to hospital. On 23 Jan 2021, all symptoms were resolved, and the patient was discharged. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, diabetic ketoacidosis (DKA), terrible migraine, nausea, heavy breathing and increased heart rate, were considered resolved on 23 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/14/2021,01/15/2021,1.0,UNK,,Asperger's syndrome; Diabetic ketoacidosis,,,,"['Diabetic ketoacidosis', 'Heart rate increased', 'Migraine', 'Nausea']",1,MODERNA,OT 1030022,TX,,M,"Hallucination; Feeling sick; High blood pressure; Oxygen was low; Covid-19; Fever; A spontaneous report was received from a consumer regarding a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced malaise, having fever, high blood pressure, abnormal, hallucination, oxygen being low/ oxygen saturation decreased, and COVID-19. The patient's medical history was not included. Products known to have been used by the patient were not provided. On 05 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date after the mRNA-1273 vaccine was given, the patient experienced being sick, having fever, high blood pressure, hallucination, and oxygen being low. On 13 Jan 2021, the patient tested positive for COVID-19. Treatment included azithromycin. Action taken with mRNA-1273 was not reported. The outcome of the events, being sick, having fever, high blood pressure, hallucination, and oxygen being low, was not reported.; Reporter's Comments: Fever is consistent with the known safety profile of the product and temporarily associated with the administration. Hence, a causal association cannot be excluded. Based on the known etiology for COVID-19 the other events are including COVID-19 are considered unlikely associated with product use and can be attributed to COVID-19 infection.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical history was not provided),,,"['Blood pressure abnormal', 'COVID-19', 'Hallucination', 'Malaise', 'Oxygen saturation decreased', 'Pyrexia', 'SARS-CoV-1 test']",1,MODERNA,OT 1030023,NY,43.0,F,"couldn't move her face and all the left side of her body/ Drooping Face/ Bell's Palsy; couldn't move her face and all the left side of her body; palm went numb; hip pain; lower leg pain; heart racing; really low blood pressure; arm was itching, her whole body was itching; Tongue and roof of the mouth numb; really bad headache; rash on both arms; nausea; vomiting; freezing; chills; Severe allergic reaction/Allergic symptoms; diarrhea; low grade fever; A spontaneous report was received from a healthcare professional who is a 43-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and couldn't move her face and all the left side of her body, her palm went numb, headache, body aches, chills, had a low-grade fever, diarrhea, arm pain, arm itched, whole body itching, rash on both arms, nausea, really bad headache, vomiting, freezing, low blood pressure, hip pain and lower leg pain and a bad headache. The patient's medical history included helicobacter pylori, two cervical spinal fusions, allergies to shellfish, strawberry leaves and dust. No concomitant product use was reported. On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-A) in the left arm intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013L20A) in the right arm intramuscularly for prophylaxis of COVID-19 infection. On 26 Dec 2020, approximately 20 minutes after receiving the Moderna COVID-19 vaccine, the patient reported she experienced a headache, body aches, chills, had a low-grade fever, diarrhea and arm pain. The headache and arm pain resolved after 4 days. On 23 Jan 2021, after the patient received her second dose of the Moderna COVID-19 vaccine, she reported her arm itched, then had whole body itched, a rash on both arms, was nauseated with a bad headache and vomiting. She stated she went to the emergency care unit and was given diphenhydramine 50 milligrams intramuscularly, a steroid injection and intravenous fluids. She stated, her legs and arms were shaking, she was freezing, and her teeth were chattering. Everything disappeared 2 hours later. The patient stated she went home but continued to vomit, had fevers, headaches, chills and body aches for two more days. On 30 Jan 2021, the patient reported she had a rash, was nauseated and her heart was racing. She road in an ambulance to the emergency room. She stated her palm went numb, she could not mover her face or the left side of her body. She stated, ""they thought I was having a stroke"". She also reported her blood pressure was low. The patient reported, they gave her Tissue Plasminogen Activator (TPA) and diphenhydramine. She reported she was able to mover her arm a little better. On unknown date, the patient reported that she was in the Coronary Care Unit (CCU) on bed rest with monitors. The patient reported she had hip pain and lower leg pain that was making her limp and a bad headache. On unknown date, the patient reported she had a magnetic resonance imaging (MRI) and computed tomography scan (CT) and stated, ""it only showed a narrow spine"". The patient stated she had a spinal fusion (date not provided). Treatment for the event included diphenhydramine, a steroid injection, intravenous fluids, and Tissue Plasminogen Activator (TPA). Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, headache and arm pain, were considered resolved on 30 Dec 2020. The outcome of the events, arm itched, whole body itching, freezing, rash on both arms, were considered resolved on 23 Jan 2021. The outcome of the events, couldn't move her face and all the left side of her body, her palm went numb, headache, body aches, chills, had a low-grade fever, diarrhea, rash, nausea, really bad headache, vomiting, low blood pressure, hip pain and lower leg pain, were considered unknown.; Reporter's Comments: This case concerns a 43-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and couldn't move her face and all the left side of her body, her palm went numb, headache, body aches, chills, had a low-grade fever, diarrhea, arm pain, arm itched, whole body itching, rash on both arms, nausea, really bad headache, vomiting, freezing, low blood pressure, hip pain and lower leg pain and a bad headache.Very limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/26/2020,12/26/2020,0.0,UNK,,Shellfish allergy,Medical History/Concurrent Conditions: H.pylori gastrointestinal disease (No reported medical history.); Spinal fusion (Date not provided.),,,"['Allergy to vaccine', 'Blood pressure decreased', 'Chills', 'Computerised tomogram', 'Diarrhoea', 'Facial paralysis', 'Feeling cold', 'Headache', 'Hemiplegia', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Magnetic resonance imaging', 'Musculoskeletal discomfort', 'Nausea', 'Pain in extremity', 'Palpitations', 'Pruritus', 'Pyrexia', 'Rash', 'Vomiting']",1,MODERNA,OT 1030024,PA,61.0,F,"Facial paralysis; Shaking all over her body/shaking for 8 days; Can not sleep; Whole body hurts and it does not go away; Terrible chills and shivers; A spontaneous report was received from a consumer who is a 61-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced facial paralysis, terrible chills, shaking for 8 days (tremors), shivers, cannot sleep (insomnia) and whole-body hurts(pain). The patient's medical history was not provided. Concomitant medications were not reported. On 13 Jan 2021, the patient received their first two planned doses of mRNA-1273 intramuscularly in her left arm for the prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient experienced terrible chills, shaking for 8 days, shivers and cold all the time, cannot sleep and whole-body hurts. On 28 Jan 2021, the patient experienced facial paralysis which was getting worse more on right side then moved to the middle of her face. The patient was given steroids. Treatment for the events included steroids. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, facial paralysis, terrible chills, shaking for 8 days (tremors), shivers, cannot sleep (insomnia) and whole-body hurts(pain), were considered unknown.; Reporter's Comments: This case concerns a 61-year-old female who experienced a serious unexpected event of facial paralysis, the non-serious unexpected events of tremors, insomnia and pain, and a non-serious expected event of chills. Events began on 21-Jan-21 after the first dose of mRNA-1273 on 13-Jan-21. Treatment with steroids. Outcomes unknown. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/21/2021,8.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Chills', 'Facial paralysis', 'Insomnia', 'Pain', 'Tremor']",1,MODERNA,OT 1030025,OK,,M,"Death; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient was died. The patient's medical history was not provided. Concomitant product use was not provided. On an unknown date, the patient received his first dose of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection. On an unknown date, the patient was died. Treatment of this event was not provided. The patient was died. The cause of death was not provided. Autopsy details were not provided.; Reporter's Comments: This case concerns a male patient (unknown age), who experienced event of death (cause unknown). The event occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. Autopsy and cause of death were not reported. Based on the current available limited information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.; Reported Cause(s) of Death: Death",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No adverse event history),,,['Death'],1,MODERNA, 1030026,,,M,"Hallucinations/ Have seen ghosts; A spontaneous report was received from a consumer who is a male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hallucinations and seeing ghosts. The patient's medical history, as reported, included problem in eye that caused patient to see weird things some years ago. Concomitant medications were not reported. On an unspecified date, the patient received their first two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced hallucinations and seeing ghosts. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event, hallucinations and seeing ghosts, was unknown.; Reporter's Comments: This case concerns a 72-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of hallucinations. Based on the current available information and temporal association between the use of the product and the onset of the event after vaccination, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Eye disorder NOS (Problem in my eye that caused me to see weird things some years ago),,,['Hallucination'],1,MODERNA, 1030027,VA,40.0,M,"Spontaneous splenic hemorrhage and rupture; Spontaneous splenic hemorrhage and rupture; A spontaneous report was received from a consumer who is a 40-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a spontaneous splenic hemorrhage and rupture. The patient's medical history was not included. Products known to have been used by the patient were not provided. On 16 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number:013L20A) for prophylaxis of COVID-19 infection. On 19 Jan 2021, at approximately 8 am, the patient suffered a spontaneous splenic hemorrhage and rupture. He went to the hospital and was admitted. On 21 Jan 2021, a splenectomy was performed. On 22 Jan 2021, he was discharged from the hospital after four days. Pathology was performed on the ruptured spleen and nothing pathological was found. All blood tests and virus tests came back negative. Cause of spleen hemorrhage and rupture was unknown. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events spontaneous splenic hemorrhage and rupture was unknown.; Reporter's Comments: This case concerns a 40-year-old male subject, who experienced serious unexpected event of Splenic hemorrhage and splenic rupture. The events occurred 3 days after the first dose of the mRNA-1273 (Lot number:013L20A) administration. Cause of events were unknown. Very limited information regarding these events have been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Yes,Yes,4.0,Not Reported,U,01/16/2021,01/19/2021,3.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No other medical history provided); Splenectomy,,,"['Splenic haemorrhage', 'Splenic rupture']",1,MODERNA,OT 1030028,IL,,M,"Both eyes with Keratoconjunctivitis virus; A spontaneous report was received from a pharmacist concerning a 75 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced both eyes with keratoconjunctivitis virus. The patient's medical history was not provided. No relevant concomitant medication was reported. On an 07 Feb 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 026L20A and expiery date 28 Jun 2021) intramuscularly for prophylaxis of COVID-19 infection. On 08 Jan 2021, the patient experienced irritated eyes, problems with vision, sensitivity to light, didn't sleep the night, and felt like someone put acid in his eyes. On 09 Jan 2021, the patient was seen by his eye doctor and diagnosed with immune response to vaccine with keratoconjunctivitis virus with no infection. Treatment included an unspecified drug. Action taken with the mRNA-1273 in response to the event was not reported. On 15 Jan 2021, the outcome of the event keratoconjunctivitis virus was resolved.; Reporter's Comments: This case concerns a 75-year-old, male, who experienced a serious unexpected event of Keratoconjunctivitis (bilateral). The events occurred 2 day after mRNA-1273 (Lot# 026L20A). Treatment information was not provided. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Keratitis'],1,MODERNA,OT 1030029,,,U,"One case of anaphylaxis, after an individual received Moderna's vaccine; A spontaneous report was received from other manufacturer Pfizer concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced one case of anaphylaxis, after an individual received Moderna's vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On an undisclosed date, the patient received their dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. Other manufacturer forwarded article posted via social media regarding COVID-19 vaccines. The article contained a brief statement from the Center for Disease Control (CDC) that stated, �they also noted one case of anaphylaxis, which can cause throat swelling and breathing difficulty, after individual received Moderna's vaccine'. No further information was provided regarding Moderna's COVID-19 Vaccine (mRNA-1273). No treatment information was provided. Action taken with RNA-1273 in response to the event was unknown. The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Anaphylactic reaction'],1,MODERNA,OT 1030042,IL,43.0,F,"Lips tingling; tongue felt full 4 mins after 1st injection; 24 hours later facial swelling and redness; 24 hours later facial swelling and redness; This is a spontaneous report from a contactable other health professional (HCP). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at 13:00 at a single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) and mild depression from an unknown date and unknown if ongoing. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), pantoprazole sodium sesquihydrate (PROTONIX) and levonorgestrel (MIRENA). The patient experienced lips tingling, tongue felt full 4 mins after 1st injection. Given IV steroids in ER. Twenty-four (24) hours later facial swelling and redness, more steroids given, symptoms resolved. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 26Dec2020 (covid test type post vaccination=Nasal Swab). Therapeutic measures were taken as a result of lips tingling, tongue felt full 4 mins after 1st injection, 24 hours later facial swelling and redness, 24 hours later facial swelling and redness. The outcome of the events was recovered on an unspecified date. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/01/2020,,PVT,TRINTELLIX; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; MIRENA,,Medical History/Concurrent Conditions: Depression; GERD,,,"['Erythema', 'Paraesthesia oral', 'SARS-CoV-2 test', 'Swelling face', 'Tongue discomfort']",1,PFIZER\BIONTECH, 1030060,AL,28.0,F,"Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,PVT,ACCUTANE,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Discomfort', 'Dizziness', 'Dysarthria', 'Dysphagia', 'Dyspnoea', 'Feeling abnormal', 'Illness', 'Ocular discomfort', 'Pallor', 'Paraesthesia', 'Rash', 'SARS-CoV-2 test', 'Speech disorder', 'Throat tightness']",1,PFIZER\BIONTECH, 1030061,MN,56.0,F,"Angioedema extending from the right side lower lip back to my ear and under my jaw on the right side/Doctor's diagnosis was angioedema secondary to vaccination; This is a spontaneous report from a contactable Other HCP (patient). This 56-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL1283) at single dose on 22Jan2021 09:00 in left arm for COVID-19 immunisation. The first dose (Lot#: EK9231) was received on 04Jan2021 at 02:30 PM in left arm. Medical history included known allergies to penicillin. Patient also had known allergies to cefalexin monohydrate (KEFLEX) in the past. There was no other medications in two weeks. There was no other vaccine in four weeks. There was no covid prior vaccination, no covid tested post vaccination. Patient experienced angioedema extending from the right side lower lip back to my ear and under my jaw on the right side on 25Jan2021 at 03:00 AM. It resulted in emergency room (ER)/department or urgent care and treatment included epinephrine, steroids, and diphenhydramine hydrochloride (BENADRYL). She went to ER due to side effect of the vaccine - Doctor's diagnosis was angioedema secondary to vaccination. The outcome of event was resolved in Jan2021.; Sender's Comments: Based on the compatible time association and drug's safe profile, the angioedema is possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/25/2021,3.0,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy,,,['Angioedema'],2,PFIZER\BIONTECH, 1030077,OK,86.0,F,"friend came down with COVID; friend came down with COVID; This is a spontaneous report from a contactable consumer (reporting for friend). A 86-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number and expiration date not reported) (at the age of 86-years-old), via an unspecified route of administration on 14Jan2021 as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that on 21Jan2021 she ""came down with COVID."" The clinical outcome of the events COVID was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and information about lot/batch number cannot be obtained. .No follow up attempts are possible.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/21/2021,7.0,UNK,,,,,,"['COVID-19', 'Drug ineffective']",UNK,PFIZER\BIONTECH, 1030079,,,F,"got a positive covid result; got a positive covid result; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported on the 17th or 18th she was sick and got a positive covid result on Jan2021. The patient underwent lab tests and procedures which included covid: positive on Jan2021. The event outcome was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1030092,NY,94.0,F,"tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a Contactable Nurse. This Nurse reported for a 94-year-old female patient (consumer's grandmother). A 94-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 19Jan2021 at single dose of second dose, on 29Dec2020 at single dose of first dose for covid-19 immunisation. Medical history included dementia, hip fracture from 19Nov2020 the patient was admitted for a broken hip on 19Nov2020, on 16Jan2021, she had a fall in the rehab facility. No Prior Vaccinations (within 4 weeks). Concomitant medication included levofloxacin (LOVENOX [LEVOFLOXACIN]) to 18Jan2021 and restarted in Jan2021, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient experienced tested positive for covid-19 on 28Jan2021. The patient was swabbed for the COVID-19 PCR test on 26Jan2021, her results came back as positive. She had a rapid COVID-19 test on 28Jan2021 that came back positive as well. The patient underwent lab tests and procedures which included chest x-ray: unknown results on 28Jan2021, COVID-19 PCR test: positive on 26Jan2021, COVID-19 Rapid Test: negative on 19Nov2020, COVID-19 Rapid Test: positive on 28Jan2021. The patient was asymptomatic. She had no fever, lungs sounded clear. The event outcome was unknown. No follow-up attempts are possible; Information on Lot/Batch number can not be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,01/28/2021,9.0,SEN,LOVENOX [LEVOFLOXACIN]; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: Broken hip (was admitted for a broken hip on 19Nov2020.); Dementia; Fall,,,"['COVID-19', 'Chest X-ray', 'Drug ineffective', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1030098,MO,50.0,F,"Covid positive; Covid positive; High fevers; Severe body aches; Lethargy; Severe headache; This is a spontaneous report from a contactable nurse (patient). A 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 23Dec2020 14:30 in right arm, at single dose for covid-19 immunization. Medical history included allergy to adhesive tape. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included flecainide. The patient previously took morphine, demerol, codeine, dilaudid and allergies to morphine,demerol, codiene, dilaudid, golytle (as reported). The patient received any other vaccines within 4 weeks prior to the COVID vaccine: product was GSK (as reported, lot number: hs75g) first dose, on 30Nov2020, in left arm. The patient experienced severe headache on 24Dec2020 04:00, lethargy on 25Dec2020, severe body aches on 26Dec2020, high fevers on 27Dec2020, covid 19 nasal swab: positive on 28Dec2020. Seriousness criteria was reported as disabling/incapacitating. Event result in clinic visit. Treatment antibiotics and prednisone was for Covid respiratory infection. The outcome of the all events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/23/2020,12/24/2020,1.0,PVT,FLECAINIDE,,Medical History/Concurrent Conditions: Adhesive tape allergy,,,"['COVID-19', 'Drug ineffective', 'Headache', 'Lethargy', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1030105,MO,57.0,F,"diagnosed with Covid; diagnosed with Covid; sore arm; more tired/Very fatigue; overall unwell feeling; slept all day long/; poor appetite/No appetite; slept all day long/Had no energy; severe aches; woke up with 102� temperature; diagnosed with strep; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 57-years-old non-pregnant female patient (nurse) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), intramuscular in the left arm on 06Jan2021 at 16:30 as a single dose, Lot number Unknown for COVID-19 vaccination. The patient medical history was not reported. The patient has no know Allergies to medications, food, or other products. Concomitant medication included levothyroxine (LEVOTHYROXINE), alprazolam (XANAX). On 07-JAN-2021 at 12:00, the patient experienced diagnosed with Covid, sore arm, more tired/very fatigue, overall unwell feeling, slept all day long, poor appetite/no appetite, slept all day long/had no energy, severe aches, woke up with 102� temperature, diagnosed with strep. Adverse event start date was reported as 07JAN2021 at 12:00 PM However, the consumer reported the sequence of events as follows. Morning after the vaccination patients complaint was a sore arm. As the day proceeding, She became more tired. The following day was Friday. Very fatigue overall unwell feeling. On the weekend, Saturday and Sunday slept all day long. Had no energy. Very poor appetite. Once again overall unwell. Was able to work approximately half days on Monday Tuesday and Wednesday. She work Hospice and did enter a facility with known positive cases but was in Full PPE with every precaution as per my norm. On Thursday in the a.m. early she woke up with 102� temperature and severe aches. Was seen at the local urgent care and diagnosed with Covid. The adverse event result in Emergency Room Visit and Physician Office Visit The patient underwent lab tests and procedures which included body temperature of 102 on 07Jan2021 and ,SARS-CoV-2 test ( Nasal Swab) Positive on 14Jan2021. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Treatment received for the events were unknown but it was also reported 'she is on second round of antibiotics And steroids. Numerous exposures over last 10 month'. The clinical outcome of the events Covid-19, sore arm, more tired/Very fatigue, overall unwell feeling, Sleep excessive, poor appetite/No appetite, slept all day long/Had no energy, severe aches, fever was recovering; while Drug ineffective was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. ,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,LEVOTHYROXINE; XANAX,,,,,"['Asthenia', 'Body temperature', 'COVID-19', 'Decreased appetite', 'Drug ineffective', 'Fatigue', 'Hypersomnia', 'Malaise', 'Pain', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test', 'Streptococcal infection']",UNK,PFIZER\BIONTECH,OT 1030106,TX,,F,"diagnosed with pneumonia; This is a Spontaneous report from a contactable consumer via a Pfizer sponsored program. A female patient (consumer) of an unspecified age received BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient medical history was not reported. Concomitant medication included cefalexin (CEPHALEXIN AMEL). Transferring agent stated, she got diagnosed with Pneumonia two days ago and she was also scheduled to have the second dose today. So, she wants to know if she can still have the second dose even though she got diagnosed with Pneumonia."" When clarified the concern, consumer stated, ""Yes, she wanted to know if she can still get her second dose today as now, she was on antibiotic, Cephalexin."" It was reported that, she was due to receive the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine today. However, she said that 2 days ago, she was diagnosed with pneumonia on an unspecified date, but tested negative for Covid-19. She also mentioned that she was currently taking antibiotics. Consumer wants to know if it was still advisable for her to receive the 2nd dose despite this. Outcome of event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,CEPHALEXIN AMEL,,,,,"['COVID-19', 'Pneumonia']",UNK,PFIZER\BIONTECH, 1030107,CA,19.0,F,"Bell's Palsy; low grade fever; body aches; chills; This is a spontaneous report received from a contactable healthcare professional (patient) communicated to a Pfizer colleague. A 19-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number: EL9261 and expiry date: 31May2021) via an unspecified route of administration to Left Deltoid on 27Jan2021 09:30 at single dose for COVID-19 immunization in workplace clinic. Patient medical history included factor V Leiden mutation (Blood Clotting disorder), common migraines, pelvic pain diagnosed 5 years ago, on 05Nov2020 hip surgery on the right side, foot surgery on 21Jan2021 with local anesthesia and nerve block in the left foot. Patient family history included mother has same Factor V Leiden mutation and father has iodine and shellfish allergy. Concomitant medications included cetirizine hydrochloride (ALERCET), gabapentin, prazosin and colecalciferol (VITAMIN D), all from an unknown date and ongoing. The patient had not received other vaccinations within 4 weeks. Patient past drugs included chlorhexidine which she experienced allergy: super itchy skin burning and lidocaine injection for local anesthesia. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284) in the right deltoid on 06Jan2021 at 09:35 Am for COVID-19 immunization. Second dose on Wednesday on left side and she stated that she had mild side effects low grade fever, body aches and chills on 27Jan2021 evening. No treatment was given for low grade fever, body aches and chills. She reported that she began to feel left sided swelling, tingling, and drooping of her face on the evening of 29Jan2021. She further described that on Friday (29Jan2021) evening her face was super weak, 1st manifestations were the eye and the left side of her face droopy and neck pain. She took 2 BENADRYL at 8:00 pm and went to sleep. At 08:00 AM next morning she took TYLENOL as her jaw and neck were hurting. She mentioned that while driving to work it got aggravated. She called advice line and she was instructed to go to emergency room. She went to emergency room and was diagnosed with Bell's Palsy on 30Jan2021 via physical exam. She has been prescribed steroids and antiviral for now (30Jan2021). Started Saturday (30Jan2021) on 20 mg prednisone daily PO (orally) for 5 days. VALTREX 1 tab PO (orally) 3xday. Erythromycin 0.5% unguent for eye 4X a day for a week. Her primary doctor increased 60 mg daily prednisone and VALTREX for a total of 10 days. And prescribed lubricant eye drops. Outcome of events Bell's Palsy was not recovered while for other events was recovered on an unspecified date in Jan2021. No follow-up attempts are possible. No further information was provided.; Sender's Comments: Based on a compatible temporal relationship, causality between event Bell's palsy and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,WRK,ALERCET; GABAPENTIN; PRAZOSIN; VITAMIN D,,Medical History/Concurrent Conditions: Common migraine; Factor V Leiden mutation (mother); Foot surgery; Hip surgery; Pelvic pain (diagnosed 5 years ago),,,"['Chills', 'Facial paralysis', 'Pain', 'Physical examination', 'Pyrexia']",2,PFIZER\BIONTECH, 1030109,CT,78.0,F,"I was in A Fib; feel strange; felt like my heart was racing; I felt shaky; This is a spontaneous report from a contactable consumer (patient). This 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL963), via an unspecified route of administration on 26Jan2021 12:00 at single dose in the left arm for COVID-19 immunization. The patient medical history included borderline high blood pressure, high cholesterol, Hashimoto's, hypothyroid. The patient's concomitant medications included rosuvastatin, levothyroxine sodium (LEVOXYL), hydrochlorothiazide and lisinpro received within 2 weeks of vaccination. The patient previously took ezetimibe (ZETIA) and experienced drug allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. After sitting in recovery room for about 10 minutes following injection patient began to feel strange. Patient called the nurse on duty and said she felt like her heart was racing. The nurse took her BP and pulseox and administered a mini EKG. Then the nurse called the EMT on duty who gave patient a six leader EKG and said patient was in A Fib. Asked if patient had ever had A fib before, patient said no. Then asked if patient wanted to go to the hospital, patient said no. After sitting with the EMT for five minutes or so another EKG showed patient was no longer in A Fib. Patient felt shaky for the rest of the day, but is normal now. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. Outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,UNK,ROSUVASTATIN; LEVOXYL; HYDROCHLOROTHIAZIDE,,Medical History/Concurrent Conditions: Borderline hypertension; Hashimoto's disease; High cholesterol; Hypothyroidism,,,"['Atrial fibrillation', 'Blood pressure measurement', 'Electrocardiogram', 'Feeling abnormal', 'Nervousness', 'Oxygen saturation', 'Palpitations']",1,PFIZER\BIONTECH, 1030112,GA,,M,"diabetes; high blood pressure; This is a spontaneous report from a Pfizer Sponsored Program. A contactable male consumer reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) at single dose for COVID-19 immunisation on 16Jan2021. Relevant history and concomitant drugs were unknown. Relevant history and concomitant drugs were unknown. The patient wanted to see his family doctor about his conditions like diabetes, high blood pressure and also about going to a urologist. Outcome of events was unknown. Information about Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,,,UNK,,,,,,"['Diabetes mellitus', 'Hypertension']",1,PFIZER\BIONTECH, 1030113,NY,,M,"His urine retention is becoming worse; His urine retention is becoming worse; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3247, on 21Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing urinary retention and taking medication. Concomitant medication included medication for urinary retention. The patient had his first shot 9 days ago. He had urinary retention and taking medication before receiving the vaccine. After taking the first shot, he said that his urine retention was becoming worse. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/01/2021,,UNK,,"Urinary retention (The caller has urinary retention and taking medication before receiving the vaccine. After taking the first shot, the caller said that his urine retention is becoming worse.)",,,,"['Condition aggravated', 'Urinary retention']",1,PFIZER\BIONTECH, 1030117,MA,,F,"bleed; big black bruise; TThis is a spontaneous report from a Pfizer-sponsored program. A contactable consumer consumer (Patient) reported a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown)), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bleed and big black bruise. The patient would like to know if the vaccine will still be effective after what happened. The outcome of the events was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,,,UNK,,,,,,"['Contusion', 'Haemorrhage']",UNK,PFIZER\BIONTECH, 1030118,CA,,F,"severe dry mouth; Nausea; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer (patient) reported that an unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 Vaccine immunization. Patient medical history and concomitant medications were not reported. On 28Jan2021 was her first dose of COVID vaccine. Seven and a half hours later she had a severe reaction had a severe dry mouth and had to go to the emergency room. Also had nausea. She was given steroids and BENADRYL. Second dose is scheduled 18Feb2021 and wondering if she can take BENADRYL before the next dose. Outcome of events was unknown. Information regarding lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/01/2021,,UNK,,,,,,"['Dry mouth', 'Nausea']",UNK,PFIZER\BIONTECH, 1030119,NC,,M,"Guillain-Barre Syndrome; This is a spontaneous report from a non-contactable physician. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, male 64 admitted at (Institution name) on 30Jan2021 with Guillain-Barre Syndrome after receiving Pfizer COVID vaccine. Event took place after use of product. It was shared on 30Jan2021 with physician by a doctor in town. They were in the doctors lounge this morning discussing the case. This was all of the information physician have. The event was considered as serious (hospitalization) by the physician. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Guillain-Barre Syndrome due to temporal relationship. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,['Guillain-Barre syndrome'],UNK,PFIZER\BIONTECH, 1030120,MO,50.0,F,"Severe headaches; Heart palpitations; Severe joint pain/ right shoulder pain; Tremors to hands; Pain in feet; Chronic neck and right shoulder pain/mid upper back; Chronic neck and right shoulder pain/mid upper back; Severe sweats from lung region up-censation of passing out; Severe nerve pain; Insomnia; This is a spontaneous report from a contactable nurse reported for herself. A 50-years-old female patient (non pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 13Jan2021 at single dose for COVID -19 immunization. Medical history included allergies to morphine,demerol, codiene, dilaudid, golytle, adhesive tape. Concomitant medication included flecainide (FLECAINIDE). The patient received any other vaccines within 4 weeks prior to the COVID vaccine: product was GSK (as reported, lot number: hs75g) first dose, on 30Nov2020, in left arm. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization on 23Dec2020 and experienced severe headache, lethargy, severe body aches, high fevers, COVID positive. The patient experienced severe headaches, heart palpatations, severe joint pain, tremors to hands, pain in feet, chronic neck and r shoulder pain/mid upper back, severe sweats from lung region up-censation of passing out, severe nerve pain, insomnia in Jan2021. It was reported as serious report, seriousness criteria was disabling/incapacitating. The adverse events result in doctor or other healthcare professional office/clinic visit. The events outcome was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/13/2021,01/01/2021,,PVT,FLECAINIDE,,Medical History/Concurrent Conditions: Adhesive tape allergy,,,"['Arthralgia', 'Back pain', 'Headache', 'Hyperhidrosis', 'Insomnia', 'Neck pain', 'Neuralgia', 'Pain in extremity', 'Palpitations', 'Tremor']",2,PFIZER\BIONTECH,OT 1030121,MD,35.0,M,"Severe elevation of blood pressure as high as 180/100; This is a spontaneous report from a contactable physician reporting for himself. A 35-year-old male received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiry date unknown), intramuscular on 30Dec2020 16:00 at a single dose on the left arm for COVID-19 immunization. Patient has no medical history. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered at the hospital. Patient received the second dose on 21Jan2021 16:00 (lot number: EL1283) intramuscular on the left arm. After the second dose in left arm, after about 24 to 48 hours, vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occured, peaking on day three and still remain after ond week. The blisters have opened leaving behind painful ulcers. This is not a rash that disappears in a few days. It will take much longer than that to heal. There was no rash with the first dose. Also, with both doses, patient had severe elevation of blood pressure as high as 180/100 within 2 to 5 hours on 30Dec2020, requiring about 3 doses of clonidine over 7 days where blood pressure would cycle up and down. Patient has no history of allergic reactions to any medications in the past or other vaccines in childhood. Otherwise, young healthy male with no history of hypertension. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient was recovering from the event. Event reported as non-serious.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of blood pressure increased. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Blood pressure increased', 'Blood pressure measurement']",1,PFIZER\BIONTECH,OT 1030125,MD,53.0,F,"reddened area with bruising with nodule; reddened area with bruising with nodule; numbness and tingling in right thumb; numbness and tingling in right thumb; EKG abnormal; large bruise on right buttock/right thigh/right arm; Chest discomfort; Heart attack; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 06Jan2021 (at the age of 53-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient experienced electrocardiogram (EKG) abnormal and large bruise on right buttock/right thigh/right arm on 08Jan2021; numbness and tingling in right thumb on 10Jan2021; reddened area with bruising with nodule on 26Jan2021; chest discomfort and heart attack in Jan2021. The clinical course was reported as follows: Two days later after vaccination, she noticed bruising on various parts of body. The first bruise she noticed on the 08Jan2021. It was probably about 3.5 inches in length 2 inches in width. The patient stated that it did not necessarily have a shape. She had a large bruise on her right buttock. Two days later, she noticed a similar in size bruise on the front of her right thigh. Then a couple days later, she noticed three quarter size bruises on her right arm (two on the inner part of arm, and one on the outer, both on upper arm). The very next day, she developed the same sizing bruise. It was about the same size on her left upper arm. There were no other side effects besides the bruising. There was no itching or redness, no skin, respiratory, or neurological issues. The day before her second dose, on 26Jan2021, she noticed a 4 inch reddened area with a two centimeter nodule inside that bruise. The patient stated that the initial bruises began to heal. They are not as dark as they were. They were reported to have started out red and then turned black and blue. The patient also had numbness and tingling in her right thumb. She was having some chest discomfort after the initial vaccination that is still ongoing. The chest discomfort prompted her to go to urgent care on 08Jan2021, where she had an abnormal EKG on 08Jan2021. The patient was told to follow up with a cardiologist. The patient saw the cardiologist on 25Jan2021, where he did an EKG and ECHO. The EKG was abnormal and ECHO with unknown results on 25Jan2021, but the doctor was unable to determine when the heart attack occurred. The cardiologist also ran labs: a troponin to see if anything was acutely going on, and a D Dimer to evaluate her clotting factors; both were negative on 25Jan2021. The cardiologist recommended a computerised tomogram (CT) scan, which was still scheduled at the time of report. The clinical outcome of large bruise on right buttock/right thigh/right arm, chest discomfort, numbness and tingling in right thumb, and reddened area with bruising with nodule was not recovered and of heart attack and EKG abnormal was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chest discomfort', 'Contusion', 'Echocardiogram', 'Electrocardiogram', 'Electrocardiogram abnormal', 'Erythema', 'Fibrin D dimer', 'Hypoaesthesia', 'Myocardial infarction', 'Paraesthesia', 'Skin mass', 'Troponin']",1,PFIZER\BIONTECH, 1030126,OH,59.0,F,"Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL9269), via an unspecified route of administration into left arm on 06Feb2021, at 15:15 as first single dose for covid-19 immunization. Medical history included high blood pressure from an unknown date, known allergies to peanuts, tree nuts from an unknown date (elaborated as allergies to peanuts, non-steroidal-anti-inflammatory drugs (NSAIDs), tree nuts, penicillin), from unknown dates. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) and unspecified multivitamins. No other-vaccines were given with four weeks. On 06Feb2021, at 15:45, the patient experienced adverse event: anaphylaxis reaction. high blood pressure. body shivering. rash on neck and chest. The events were serious as they were life-threatening. The events were noted as resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and was life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included blood pressure measurement: high on 06Feb2021. Therapeutic measures were taken as a result of the adverse events; dexamethasone sodium phos- diphenhydramine (BENADRYL), famotidine. No covid infection was noted prior to vaccination. No covid test has been administered post vaccination. The outcome of events was recovered in Feb2021.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/06/2021,02/06/2021,0.0,UNK,LISINOPRIL,,"Medical History/Concurrent Conditions: Allergy to nuts (Known- allergies: Peanuts, NSAIDs, Tree nuts, penicillin); Drug allergy; Hypertension (Other-medical-history: High blood pressure); Penicillin allergy",,,"['Anaphylactic reaction', 'Blood pressure increased', 'Blood pressure measurement', 'Chills', 'Rash']",1,PFIZER\BIONTECH, 1030127,,,M,"got the shot in the upper arm but on his forearm it looked like he had cellulitis; It was all red and swollen and warm on touch; It was all red and swollen and warm on touch; It was all red and swollen and warm on touch; This is a spontaneous report from a non-contactable consumer. A male patient (reporter's father) of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated the patient got the shot in the upper arm but on his forearm it looked like he had cellulitis. It was all red and swollen and warm on touch. The reporter didn't know if that's the side effects from the vaccine or not. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Cellulitis', 'Erythema', 'Feeling hot', 'Peripheral swelling']",UNK,PFIZER\BIONTECH, 1030128,TN,,M,"Dementia; He has a temperature of 100.7; Labored breathing/Very hard time breathing; Dizziness; He has been freezing all day, he is so cold; Pulse 84; This is a spontaneous report from a contactable consumer and a non-contactable consumer. This consumers (patient's son and wife) reported that a 92-years-old male patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3248), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunization. Medical history included allergic to Penicillin. The patient's concomitant medications were not reported. The patient had his Covid19 vaccination on the 29Jan2021 last Friday, he had dementia, he had a temperature of 100.7, pulse 84, labored breathing, dizziness in Jan2021 and so the son asked if this was a normal reaction he was also allergic to Penicillin. The patient had been freezing all day, he was so cold and they had been giving him a lot of water and he had a temperature tonight (as reported) and had very hard time breathing in Jan2021. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Body temperature', 'Body temperature increased', 'Dementia', 'Dizziness', 'Dyspnoea', 'Feeling cold', 'Heart rate', 'Pulse abnormal']",UNK,PFIZER\BIONTECH, 1030129,AL,57.0,F,"Nerve Damage Symptoms; its achy all on the left side; shoulder pain; Being lower back pain; the pain in shoulder went to the arms, back across to the front of the chest; dull aching pain; she didn't sleep; groggy; The pain in shoulder went to the arms, back across to the front of the chest; This is a spontaneous report from a contactable consumer (patient). A 57-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK9231) (at the age of 57-years-old), via an unspecified route of administration on 20Jan2021 as a single dose for covid-19 immunization. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient medical history included acid reflux She has been good for last 2 months. She was on Pepcid but not anymore; uterine polyp removal in 2019 (reported as 2 years ago) polyps removed from uterine wall, it was done outpatient but they still put her to sleep, but it had took her 2 weeks to get over the reaction of being put to sleep, it was the anesthesia, it wasn't pain, but she was very tired and groggy after. She does not know the name of the Anesthesia or have any Lot or Expiry; receives flu shot every year with no issue. The patient was not taking any concomitant medications. She has had No positive antibody or Covid test prior to the vaccine. She took the first shot last Wednesday 20Jan2021, she had a weird, not the usual reactions like she had read about. She even went to the Nurse Practitioner yesterday because of it. She was told she has nerve damage from the shot and a high immune response to the shot, which is a good thing, but her question is does she take the second shot. The nerve damage started at 10 o clock that night causing shoulder pain, back pain, being lower back pain, because of it she didn't sleep, only 3 hour Thursday night. She's a teacher and even had to miss school on Friday. It is just a constant dull aching pain. She was groggy. Some symptoms were typical. She never ran a fever, the pain in shoulder went to the arms, back across to the front of the chest, she can follow with the hand here, its achy all on the left side. She went to the Nurse Practitioner and she said it sounds like nerve damage. The NP did not do any test, she really just left the office hoping that it would resolve on its own. Caller states that this is not going away. She actually read to not even take Tylenol or Advil 2 days prior as it can lessen the effectiveness of the vaccine. That's why she didn't take Tylenol till Friday Afternoon on 22Jan2021. She toughed it out for 2 days. The doctor told her she can take Advil right now. The clinical outcome of the event: Low Back pain recovered; event Nerve damage was recovering; events achy all on the left side, Dull aching pain, shoulder pain, chest pain, Pain in arm, she didn't sleep, groggy unknown. She is scheduled for the second dose on 10Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/01/2021,,PVT,,,"Medical History/Concurrent Conditions: Acid reflux (esophageal) (under control; has been good for last 2 months;was on Pepcid but not anymore.); Uterine polypectomy (2 years ago, polyps removed from uterine wall, done outpatient; put her to sleep)",,,"['Arthralgia', 'Back pain', 'Chest pain', 'Nerve injury', 'Pain', 'Pain in extremity', 'Sleep disorder due to a general medical condition', 'Somnolence']",1,PFIZER\BIONTECH, 1030130,GA,65.0,F,"Swelling of tissue above and under eyes; Swelling of left cheek; Pressure in lymph nodes; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264), via an unspecified route of administration in the right arm on 03Feb2021 at 12:00 (at the age of 65-years-old) as a single dose for COVID-19 immunization. Medical history included high creatinine levels and shellfish allergy; all from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included acetylsalicylic acid (BAYER ASPIRIN) and simvastatin (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021 at 13:00, the patient experienced swelling of tissue above and under eyes, swelling of left cheek, pressure in lymph nodes, and nausea; all serious for being life threatening. The patient was treated with diphenhydramine hydrochloride (BENADRYL). The clinical outcomes of swelling of tissue above and under eyes, swelling of left cheek, pressure in lymph nodes, and nausea were recovering.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/03/2021,02/03/2021,0.0,UNK,BAYER ASPIRIN; SIMVASTATIN,,Medical History/Concurrent Conditions: Creatinine high (High creatinine levels); Shellfish allergy (Known allergies: Shellfish),,,"['Blood creatinine', 'Eye swelling', 'Lymphadenopathy', 'Nausea', 'Swelling face']",1,PFIZER\BIONTECH, 1030131,VA,55.0,F,"Basal Ganglia sudden stroke; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 30Jan2021 at 13:00 (at the age of 55-years-old) at a single dose for COVID-19 immunization. The patient had no medical history and no blood pressure condition. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included an unspecified thyroid medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced basal ganglia sudden stroke on 30Jan2021 at 13:00, which prolonged hospitalization, caused disability, and was reported as life-threatening. The vaccine was received during existing hospitalization. The patient underwent lab tests and procedures which included nasal swab: negative on 03Feb2021. Therapeutic measures were taken as a result of the event, which included intensive care unit (ICU) neurocare. The clinical outcome of basal ganglia sudden stroke was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Yes,Not Reported,,Yes,U,01/30/2021,01/30/2021,0.0,PUB,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Basal ganglia stroke', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1030132,,,U,"a doctor died of low platelet and brain bleed 16 days after the vaccine; a doctor died of low platelet and brain bleed 16 days after the vaccine; The is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient (doctor) died of low platelet and brain bleed 16 days after the vaccine. It was not reported if an autopsy was performed. Information about lot/batch number has been requested.; Reported Cause(s) of Death: a doctor died of low platelet and brain bleed 16 days after the vaccine; a doctor died of low platelet and brain bleed 16 days after the vaccine",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Cerebral haemorrhage', 'Death', 'Platelet count decreased']",UNK,PFIZER\BIONTECH, 1030134,OH,52.0,F,"At approximately 16:00 started shaking; extremely cold; Both arms as well as pectoral muscles hurt; Both arms as well as pectoral muscles hurt; Very dizzy; fever up to 102.1 Fahrenheit; uncomfortable like I needed to get something out my body; This is a spontaneous report from a contactable nurse reported for herself. A 52-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 29Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included HTN (hypertension). Concomitant medication included losartan and hydrochlorothiazide (HCT) received in two weeks. There was no other vaccine received in four weeks. At approximately 29Jan2021 16:00, the patient started shaking and extremely cold. The patient experienced both arms as well as pectoral muscles hurt. The patient experienced very dizzy and uncomfortable like she needed to get something out her body. This lasted for over 24 hours with fever up to 102.1 Fahrenheit. All events occurred on 29Jan2021 16:00. The events resulted in congenital anomaly or birth defect (pending clarification). No treatment received for the events. The patient was no pregnant. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,SEN,LOSARTAN; HCT,,Medical History/Concurrent Conditions: Hypertension,,,"['Body temperature', 'Discomfort', 'Dizziness', 'Feeling cold', 'Myalgia', 'Pain in extremity', 'Pyrexia', 'Tremor']",1,PFIZER\BIONTECH,OT 1030135,MN,80.0,M,"rash all over his back and it itched like crazy and then started bleeding; rash all over his back and it itched like crazy; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EK4176, via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunisation. Medical history included heart disorder from an unknown date. Concomitant medications included a lot of medications for his heart and stuff. In Jan2021 the patient experienced rash all over his back and it itched like crazy and then started bleeding when he scratched. He received Benadryl tablets lotion on it as treatment. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Heart disorder,,,"['Purpura', 'Rash pruritic']",UNK,PFIZER\BIONTECH, 1030136,NY,47.0,F,"syncopal episode; Swollen lymph nodes in left neck and left arm pit; Nausea within a couple of hours of vaccine /continued nausea; Fatigue; fever; chills; headache; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 47-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283), via an unspecified route of administration in left arm on 27Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included very infrequent anxiety and headaches, only after illness. Concomitant medication included sertraline, ethinylestradiol, norethisterone acetate (JUNEL), fluticasone propionate (FLONASE). The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies to Compazine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), via an unspecified route of administration at the age of 47-year-old in left arm on 06Jan2021 10:30 at single dose for COVID-19 immunization. The patient experienced nausea within a couple of hours of vaccine. The patient experienced fatigue, fever, chills, headache, continued nausea, dizziness with 1x syncopal episode, swollen lymph nodes in left neck and left arm pit, mostly resolved after 3 days. She had still with headache. All events occurred on 27Jan2021 14:30. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The patient did not receive any other vaccines in four weeks. The patient was no pregnant. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the event headache was not recovered and the outcome of the other events was recovering.; Sender's Comments: Based on a compatible temporal relationship causality between event syncopal episode and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,SEN,SERTRALINE; JUNEL; FLONASE [FLUTICASONE PROPIONATE],,Medical History/Concurrent Conditions: Anxiety; Headache; Illness,,,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Lymphadenopathy', 'Nausea', 'Pyrexia', 'Syncope']",2,PFIZER\BIONTECH, 1030138,,,U,"allergic to the flu shot; Initial information received on 28-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves adult patient who was allergic to the flu shot (Allergy to vaccine), while he/she received INFLUENZA VACCINE. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious allergic to the flu shot (Allergy to vaccine) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported that the patient was not taking any chances on the COVID (corona virus disease) vaccine. It was unknown if the patient experienced any additional symptoms/events. No relevant laboratory tests were reported. It was not reported if the patient received any corrective treatment. The outcome of the event was unknown at the time of reporting. There will be no information available on batch numbers.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination complication'],UNK,UNKNOWN MANUFACTURER,OT 1030210,LA,64.0,F,"experiencing symptoms of Bells Palsy / diagnosed by her HCP with Bells Palsy on 2-3-2021; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 15th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 30th January 2021, 46 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). The patient was treated with prednisone. On an unknown date, the outcome of the bell's palsy was not recovered/not resolved. It was unknown if the reporter considered the bell's palsy to be related to Shingrix. Additional details were provided as follows: The patient received 2nd dose of Shingrix and experienced bells palsy. The patient was treated with prednisolone for these symptoms. The reporter did not consent to follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/15/2020,01/30/2021,46.0,UNK,,,,,,['Facial paralysis'],2,GLAXOSMITHKLINE BIOLOGICALS,IM 1030214,IN,42.0,F,"woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all mucosal linings; Mallampati score 4, not my baseline; Moderate fatigue rest of the day; Sore arm was experienced within 5 hours of administration; This is a spontaneous report from a contactable Nurse reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration at Left arm on 29Dec2020 17:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypertension (HTN), ablation corrected Wolff-Parkinson-White syndrome, pre-eclampsia. The patient was not pregnant. Concomitant medication included hydrochlorothiazide, triamterene (MAXZIDE), ibuprofen, naproxen sodium (ALEVE) and Women's multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took trolamine polypeptide oleate-condensate (CERUMENEX) and experienced allergy. The patient's sore arm was experienced within 5 hours of administration on 29Dec2020. Next morning 15 hours post, woke with swollen tongue, throat, and all mucosal linings. Mallampati score 4, not her baseline. Moderate fatigue rest of the day. Finally took Benadryl at 23-hours post vaccine, had to repeat Benadryl every 8 hours for 2 more days and monitor symptoms, events onset date was 30Dec2020 08:30. Adverse events result in: Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of Swollen tongue, Throat edema, Oral mucosa swollen, and Physical examination abnormal cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,MAXZIDE; IBUPROFEN; ALEVE,,Medical History/Concurrent Conditions: Cardiac ablation (ablation corrected Wolff-Parkinson-White syndrome); Hypertension; Pre-eclampsia; Wolff-Parkinson-White syndrome (ablation corrected Wolff-Parkinson-White syndrome),,,"['Fatigue', 'Mallampati score', 'Mouth swelling', 'Pain in extremity', 'Pharyngeal oedema', 'Physical examination abnormal', 'Swollen tongue']",1,PFIZER\BIONTECH, 1030215,MA,65.0,F,"neuropathy; Day 4 after injection, heat sensitivity in hands and feet; tingling in hands/feet; sharp burning needles sensation up arms and legs; Tips of fingers and toes were numb and felt swollen; Tips of fingers and toes were numb and felt swollen; Hands then started peeling, palms became thickened and rough; This is a spontaneous report from a contactable healthcare professional, the patient. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the right arm on 22Dec2020 at 08:30 (at the age of 65-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included A-fib (atrial fibrillation), GERD (gastroesophageal reflux disease) and osteoporosis. Concomitant medications included atenolol, calcium, acetylsalicylic acid (ASPIRIN), famotidine (PEPCID) and omeprazole. Past drug history included known allergies: fexofenadine (ALLEGRA) and codeine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 26Dec2020, day 4 after injection, the patient experienced heat sensitivity in hands and feet, followed by tingling in hands > feet, with sharp burning needles sensation up arms and legs. Heat sensitivity continued. Tips of fingers and toes were numb and felt swollen for several days, while neuropathy continued. Hands then started peeling, palms became thickened and rough. For the events neuropathy, heat sensitivity in hands and feet, tingling in hands/feet, burning needles sensation, tips of fingers and toes were numb and felt swollen, and hands then started peeling an emergency room visit and physician office visit was required. Unspecified treatment was provided for the events neuropathy, heat sensitivity in hands and feet, tingling in hands/feet, burning needles sensation, tips of fingers and toes were numb and felt swollen, and hands then started peeling. The outcome of the events neuropathy, heat sensitivity in hands and feet, tingling in hands/feet, burning needles sensation, tips of fingers and toes were numb and felt swollen, and hands then started peeling was recovering. Since the vaccination, the patient has been tested for COVID-19. Nasal Swab on 13Jan2021 was negative and on 19Jan2021 was negative. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The information is limited and does not allow a full medical assessment. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of neuropath, cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/26/2020,4.0,PVT,ATENOLOL; CALCIUM; ASPIRIN [ACETYLSALICYLIC ACID]; PEPCID [FAMOTIDINE]; OMEPRAZOLE,,Medical History/Concurrent Conditions: AFib; GERD; Osteoporosis,,,"['Burning sensation', 'Hypoaesthesia', 'Neuropathy peripheral', 'Paraesthesia', 'SARS-CoV-2 test', 'Skin exfoliation', 'Swelling', 'Temperature intolerance']",1,PFIZER\BIONTECH,OT 1030267,NY,,U,"other zoster-related conditions; shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On an unknown date in 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On unknown dates, subsequently to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles and other zoster-related conditions. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered not recovered/not resolved (reported as would continue suffer ongoing injuries). The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).",Not Reported,,Not Reported,Yes,,Not Reported,N,,,,PHM,,,,,,['Herpes zoster'],UNK,MERCK & CO. INC.,OT 1030269,NC,,U,"other zoster related conditions; shingles; Information has been received from a lawyer and refers to a patient of unknown age and gender. The patients concurrent conditions and historical conditions were not reported. On or about 11-AUG-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported), as prescribed and/or administered by a pharmacist at pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles and other zosterrelated conditions.As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was not reported. The evenst were considered to be related to zoster vaccine live (ZOSTAVAX).",Not Reported,,Not Reported,Yes,,Not Reported,U,08/11/2016,,,PHM,,,,,,['Herpes zoster'],UNK,MERCK & CO. INC.,OT 1030270,AZ,,M,"died from heart problems; suspected vaccination failure; shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of heart disorder in a elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had shingles when he was 8 years.). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced heart disorder (serious criteria death), vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the heart disorder was fatal and the outcome of the vaccination failure, shingles and pain were unknown. The reported cause of death was heart disorder. It was unknown if the reporter considered the heart disorder, vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were reported as follows: The patient received shingrix in his early 80s and he ended up with shingles. The patient had bad pain until he died from heart problems.; Reported Cause(s) of Death: Heart disorder",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: Shingles (had shingles when he was 8 years.),,,"['Cardiac disorder', 'Death', 'Herpes zoster', 'Pain', 'Vaccination failure']",UNK,GLAXOSMITHKLINE BIOLOGICALS, 1030272,MD,,F,"Skin necrosis; Severe dermatitis; Left side macerated with stuff all over it; Bilateral axillary pain that got worse and worse; Left side-patient reported that it was draining; Bilateral axillary swelling that got worse and worse; A spontaneous report was received from a physician concerning a 34-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe dermatitis, skin necrosis, bilateral axillary pain that got worse and worse, bilateral axillary swelling that got worse and worse, left side macerated with stuff all over it and left side-patient reported that it was draining. The patient's medical history was not provided. No relevant concomitant medications were reported. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On unknown date, the patient developed systemic reactions for a couple days with bilateral axillary swelling and pain that got worse and worse. She developed severe dermatitis with skin necrosis. On 10 Jan 2021, the patient went to urgent care and was given methylprednisolone 50 mg for four days. Her left side especially was swelling and was macerated with stuff all over it. The patient reported that it was draining also. A computerized axial tomography (CAT) scan did not show any abscess; it showed several lymph nodes on left axilla with the largest being 1.5 centimeters (CM), nothing impressive and nothing that explains skin necrosis. Her white blood cell count (WBC) was 18 (units and reference ranges were not provided) and vital signs were stable with no fever. On exam, the only thing the doctor found was a small lymph node in the right axillary area, and the left axillary area was significantly more swollen. The injection site on the left arm has nothing. On unknown date, the patient was at the hospital and given antibiotics and methylprednisolone. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, severe dermatitis, skin necrosis, bilateral axillary pain that got worse and worse, bilateral axillary swelling that got worse and worse, left side macerated with stuff all over it and left side-patient reported that it was draining, were not reported.; Reporter's Comments: This case concerns a 34-year-old, female patient, who experienced a serious unexpected event of skin necrosis, non-serious unexpected event of dermatitis, skin maceration, axillary pain, wound secretion, and non-serious expected event of lymphadenopathy. The events occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Laboratory tests revealed WBC 18 and a CT scan showed several lymph nodes on left axilla with no abscess. Treatment included antibiotics and Medrol. Very limited information regarding these events has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/05/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Axillary pain', 'Computerised tomogram', 'Dermatitis', 'Lymphadenopathy', 'Skin maceration', 'Skin necrosis', 'White blood cell count', 'Wound secretion']",1,MODERNA,OT 1030273,,,U,"Death; A spontaneous report was received from a reporter concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed away. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 on 28 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection. On 30 Dec 2020, 2am the patient passed away. Administrator marked as natural causes. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was fatal. The patient died on 30 Dec 2020. The cause of death was reported as unknown. The reporter did not provide an assessment for the event, passed away.; Reporter's Comments: This case concerns a patient of unknown age and gender. The medical history and concomitant medication is not provided. The patient experienced Death. The event occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death",Yes,12/30/2020,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/30/2020,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Death'],1,MODERNA,OT 1030274,CA,,U,"Angioedema; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angioedema. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 12 Jan 2021, after vaccine administration, the patient experienced a severe allergic event. The event was angioedema which required multiple epinephrine injections. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, angioedema, was unknown.; Reporter's Comments: This case concerns a patient, who experienced event of angioedema. The event occurred the same day after the first and last dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/12/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,['Angioedema'],1,MODERNA,OT 1030295,MA,80.0,M,"A few hours after receiving first dose of vaccine, developed extreme leg weakness (unable to stand). This persisted for two days and pt was sent to emergency room. Initial evaluation at ER revealed leg weakness only. After 24 hours observation, it was noted that the patient had left sided weakness and slurred speech. MRI confirmed acute infarct in right pons area.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/11/2021,02/11/2021,0.0,PVT,"SIMVASTATIN, ASPIRIN, WELLBUTRIN, GLUCOPHAGE, TIMALOL EYE DROPS, VIT D, VIT C, METOPROLOL, SYMBICORT, DIOVAN, DOXAZOSIN, ARICEPT","DEMENTIA, DIABETES, ATAXIA, DEPRESSION, HYPERTENSION, HYPERLIPEDEMIA, BIFASICULAR BLOCK, COPD",SEE ABOVE,,SERTRILINE,"['Arteriogram carotid abnormal', 'Brain stem infarction', 'Cerebral infarction', 'Computerised tomogram head', 'Dysarthria', 'Dysstasia', 'Magnetic resonance imaging brain abnormal', 'Muscular weakness']",1,MODERNA,IM 1030304,TN,50.0,F,"Anaphylactic Reaction: itching, redness of skin, wheezing, esophageal spasms and constriction requiring 911, ER and anaphylactic protocols",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,OTH,none,none,cancer survivor >10yrs,,"zofran, hydrocodone, scopolamine","['Anaphylactic reaction', 'Erythema', 'Oesophageal spasm', 'Pruritus', 'Wheezing']",2,MODERNA,IM 1030323,WI,66.0,M,"Patient had COVID vaccination on 2/3 with no adverse s/s before leaving unit. Upon coming to treatment Friday 2/5 he reported to the RN that he had fallen on thursday 2/4 due to ""getting up fast"" did not hit head or hurt anything per RN discussion. Began treatment without difficulty. About 3/4 way through treatment was talking with staff and became unresponsive - code was called and pt expired after 30 minute resuscitation efforts.",Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/05/2021,2.0,OTH,Albuterol Alirocumab Asprin Atrorvastatin Calcium Budesonide-Formoterol Fumarate Calcitriol Calcium Acetate Carvedilol Clopidogrel Bisulfate Erogcalciferol Ezetimibe Fluticasone-Salmetrol Lasix Glucagon Hydralazine Insulin Ipratropium inhal,Asymptomatic COVID Hospital for Polymosis January,ESRD Diabetes Type 2 Heart disease CHF CAD CABG,,Niacin,"['Blood potassium normal', 'Blood sodium normal', 'Carbon dioxide normal', 'Cardio-respiratory arrest', 'Death', 'Fall', 'Haemoglobin decreased', 'Laboratory test', 'Resuscitation', 'Unresponsive to stimuli']",UNK,MODERNA,IM 1030412,NY,29.0,F,My arm has been in dire pain for 10 days. I do not have range of motion and cannot lift arm or hold heavy objects. No OTC pain medication helps. I cannot sleep because of the pain.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/05/2021,02/05/2021,0.0,SCH,None,None,None,,Sulfur,"['Joint range of motion decreased', 'Motor dysfunction', 'Pain in extremity', 'Sleep disorder']",1,MODERNA,IM 1030424,WA,,F,"Treated for cancer after the first shot / diagnosed with cancer after / 1st / vaccine; This case was reported by a consumer via call center representative and described the occurrence of cancer in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer was unknown. It was unknown if the reporter considered the cancer to be related to Shingrix. Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported. The patient received first shot two years ago from the reporting date. The patient was diagnosed with cancer after receiving 1st dose. The patient asked, if get treated for cancer after the first shot, should you start over after 2 years, as she just received one more shot. The patient was advised to not get second shot during treatment. The consent to follow-up was requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Neoplasm malignant'],1,GLAXOSMITHKLINE BIOLOGICALS, 1030425,SC,,F,"passed out a few minutes after receiving the dose; This case was reported by a nurse via call center representative and described the occurrence of passed out in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Previously administered products included methotrexate and Immunoglobulin therapy. Concurrent medical conditions included multiple sclerosis, hypertension, allergy to chemicals (to detergent), bee sting, perfume sensitivity and wasp sting. Concomitant products included prednisone, baclofen, gabapentin, benadryl (nos) (Benadryl) and paracetamol (Tylenol). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season (intramuscular). On an unknown date, several minutes after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced passed out (serious criteria GSK medically significant). The patient was treated with sodium chloride. On an unknown date, the outcome of the passed out was recovered/resolved. It was unknown if the reporter considered the passed out to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The concomitant medication included antihypertensive. The patient also mentioned that she received a dose of a flu vaccine (unknown manufacturer) in the past and passed out a few minutes after receiving the dose. Patient states that she received normal saline after she passed out, however, she was not hospitalized. The patient was at work (at a hospital) when this event occurred. The reporter did not consent to follow-up. This case was linked with the case US2021AMR034326 reported for same patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR034326:same reporter, pharma case",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,PREDNISONE; BACLOFEN; GABAPENTIN; BENADRYL; TYLENOL,Allergy to chemicals (to detergent); Bee sting; Hypertension; Multiple sclerosis; Perfume sensitivity; Wasp sting,,,,['Loss of consciousness'],UNK,UNKNOWN MANUFACTURER,IM 1030426,WV,76.0,F,"Hemorrhage on right eye; A spontaneous report was received from a consumer concerning a 76-year-old, female patient who received Moderna's COVID-19 vaccine and experienced hemorrhage on the right eye. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection. On 29 Jan 2021, the day following her injection, the patient experienced a right eye hemorrhage. The patient also informed that she had a substance of unknown origin injected into her eye, when she visited the eye doctor. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The second dose is scheduled for 24 Feb 2021. The outcome for the event hemorrhage on the right eye was not reported.; Reporter's Comments: This case concerns a 76-year-old, female, who experienced serious events of Eye haemorrhage after receiving first dose of mRNA-1273. Noting her recent visit (unknown date) to an eye doctor involved an injection into her eye may remain as confounder. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Follow-up information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/29/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Therapeutic procedure (Eye doctor appointment when they injected something in the eye),,,['Eye haemorrhage'],1,MODERNA,OT 1030447,OH,46.0,F,"02/04/21-groin pain/burning, buttocks and thighs muscle tightness, unable to sit for extended period of time due to groin discomfort 02/05/21-continued groin pain, new bilateral arm/bicept muscle pain with right side worse than left 02/06/21- headache, loss of appetite, chills, shoulder/neck/jaw/hips joint pain 02/07/21-back and ribs pain with sitting or lying- unable to sleep due to extreme pain, unable to transition from lying to sitting to standing due to pain, fever 101.8, worsening of all symptoms. Employee Health contacted, instructed to obtain Covid test, results negative. 02/08/21-First day missed work. Continued worsening of pain, groin and hip pain radiating down the back of both legs to back of both knees 02/09/21- Excruciating pain, difficulty with ambulating. Seen at Emergency Department, labs and imaging obtained, informed of bilateral Pulmonary Embolisms, admitted for treatment.",Not Reported,,Yes,Yes,3.0,Not Reported,U,01/25/2021,02/04/2021,10.0,PVT,"Lisinopril, Lipitor, Fish Oil, D3, Black Cohosh, Melatonin",none,"hypertension, hyperlipidemia",,NKA,"['Arthralgia', 'Back pain', 'Burning sensation', 'Chills', 'Decreased appetite', 'Dysstasia', 'Groin pain', 'Headache', 'Imaging procedure', 'Impaired work ability', 'Injection site pain', 'Laboratory test', 'Mobility decreased', 'Muscle tightness', 'Musculoskeletal chest pain', 'Musculoskeletal discomfort', 'Myalgia', 'Neck pain', 'Pain', 'Pain in extremity', 'Pain in jaw', 'Pulmonary embolism', 'Pyrexia', 'SARS-CoV-2 test negative', 'Sleep disorder', 'Spinal pain']",2,MODERNA,SYR 1030461,IN,,F,Per reported event on 2/8/21: Pt presents to ED (on 2/8/21) from assisted living facility for evaluation of falls x 2 this am. Pt received his first moderna injection Saturday 2/6/21 and reported chills and fever on Sunday 2/7/21. Today he rolled out of bed around 0400 but denies injury from the fall. The pt was reported to have pronounced generalized weakness. The second episode the parient was in a chair this am and couldn't get up. The staff assisted him to the toilet and his legs gave out and he went down again but the staff were able to control him and no injuries were noted. He normally ambulates independently and can still drive. He gets routine covid testing and he was negative on Friday. He presents today with a rectal temp of 100. Good rectal tone noted. He is able to lift each leg with no drift noted and able to meet resistance with his feet. He reports lower back pain and generalized body aches. Pt is alert and oriented x 3. No c/o diarrhea or vomiting. NO cough or shortness of breath. Moderna Vaccine Lot # 032L20A Note: Vaccine administration unknown; Patient was admitted to Hospital,Not Reported,,Not Reported,Yes,2.0,Not Reported,,02/06/2021,02/07/2021,1.0,PVT,,,,,,"['Asthenia', 'Back pain', 'Body temperature increased', 'Chills', 'Dysstasia', 'Failure to thrive', 'Fall', 'Pain', 'Pyrexia']",1,MODERNA, 1030468,NE,76.0,M,"Pt presents to ER with increased weakness, hypoxia, history of COPD, but not oxygen dependent., hypotension. Acute Kidney failure noted in labs, not previously diagnosed , new hyperkalemia. BP 73/39, HR 67. dopamine initiated, and switched to Levophed. Oxygen Sat 86%, requiring 10 L O2. Transferred from this critical access hospital to another Hospital. Expires later 2-13-2021",Yes,02/13/2021,Not Reported,Yes,,Not Reported,N,02/11/2021,02/12/2021,1.0,PVT,"Lisinopril, Flomax, Sotalol, simvastatin, Xarelto, Requip, Omeprazole, symbicort, Albuterol Aerosol, Furosemide.","ACUTE KIDNEY FAILURE, QUESTION SEPSIS, CHF, ATRIAL FIBRILLATION, COPD, GERD, RESTLESS LEG SYNDROME, HISTORY OF PROSTATE CANCER, HYPERTENSION, CURENT TOBACCO USAGE","COPD, CHF, ATRIAL FIBRILLATION, GERD, RESTLESS LEG, HISTORY OF PROSTATE CANCER, HYPERTENSION",,none,"['Acute kidney injury', 'Asthenia', 'Blood creatinine increased', 'Blood potassium increased', 'Brain natriuretic peptide increased', 'C-reactive protein increased', 'Death', 'Hyperkalaemia', 'Hypotension', 'Hypoxia', 'White blood cell count increased']",1,MODERNA,IM 1030523,OH,93.0,M,"Patient received his second dose of the Pfizer vaccine. He was accompanied by his daughter. Per daughter prior to receiving his vaccine he was his ""normal"" self. He was sitting in a chair next to the vaccinator. He did walk in with a walker and minimal assistance from his daughter. He did have a gait belt on around his waist. � When I came to patient he was looking straight ahead with his left eye open - right eye s/p surgery to his right eye per daughter. He did not respond to questions asked. His daughter stated mentally he is normally intact. His pulse was faint but palpable. His color was pale with slight dusky skin to hands. 911 was called. Undetectable blood pressure initially with his faint pulse. Initially his heart rate was 105. He was shallow breathing. � BP was undetectable sitting - with oxygenation low 80's on room air. He was lifted to a bed/cart with legs elevated. He was given supplemental oxygen. After laying down with legs up he started to look around. He was able to tell me his name and respond to questions. � His blood pressure was 117/68 with heart rate 55 and oxygenation on 6L nasal cannula 87-88%. � Patient's daughter stated that patient was recently at hospital with low blood pressure and questionable seizure activity. No obvious seizure activity noted today. � Parametics - updated with patient history and events. Blood sugar checked at 183. Patient neurologically improved with ability to state name, his daughters name and his age. � No injury noted. Dr phoned and updated on patient condition and events. Patient transported without injury on oxygen. Two daughters with patient to emergency room. Pt being evaluated by cardio on admission for sycope/possible seizure. Still admitted",Not Reported,,Not Reported,Yes,,Not Reported,U,02/13/2021,02/13/2021,0.0,PVT,,History of seizures/syncope,,,NKA,"['Heart rate decreased', 'Hypopnoea', 'Mental status changes', 'Oxygen saturation decreased', 'Pallor']",2,PFIZER\BIONTECH,SYR 1030540,RI,35.0,F,"Event - 22 week stillbirth Pregnancy history - G2P1001, EDD 6/13/2021, h/o twin gestation with 1st trimester vanishing twin. Otherwise uncomplicated.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/14/2021,02/10/2021,27.0,PVT,"Prenatal Vitamins, Docusate 100mg, Famotidine 20mg, 81mg Aspirin",Viral URI one month prior,none,,none,"['Exposure during pregnancy', 'Stillbirth', 'Vanishing twin syndrome']",2,PFIZER\BIONTECH,SYR 1030551,AL,85.0,M,"No adverse effects for the first two weeks. The morning of 2/7/21 he claimed he was not able to sleep the night before. He was cold, but only wanted something cold to drink. He was not able to get through his normal morning routine. By 8 am we was beginning to get confused and weaker. By 9 am he vomited and was not able to stand up or walk. The confusion was increasing. We called 911. When they arrived he had chills and was agitated. He did not have a fever at that time. He was transported to the emergency room. We were not able to accompany him there, but were told he was confused, agitated and combatant. His fever was up to 101 degrees. The started him on antibiotics and began tests. He tested negative for COVID and the flu. By that evening they diagnosed him with viral meningitis and admitted him to the hospital. The next day we were told that they had ruled out viral meningitis as well as other infections. The infectious disease doctor said that all tests had come back negative, but they were continuing to give him antibiotics. A neurologist and cardiologist were called in and they were not able to find anything either. He did complain of chest pains, but it was determined that it might be heart burn. They did see a sign of Afib, but test were not conclusive. On Friday, Feb. 12th he was sent home with antibiotics and heart medicines. The confusion has improved, but he is very weak and not mobile without assistance.",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,01/25/2021,02/07/2021,13.0,WRK,Vitamin D3,None,None,,None,"['Aggression', 'Agitation', 'Asthenia', 'Atrial fibrillation', 'Chest pain', 'Chills', 'Confusional state', 'Dyspepsia', 'Dysstasia', 'Feeling cold', 'Gait inability', 'Influenza virus test negative', 'Meningitis viral', 'Mobility decreased', 'Pyrexia', 'SARS-CoV-2 test negative', 'Sleep disorder', 'Viral test negative', 'Vomiting']",1,PFIZER\BIONTECH,UN 1030554,PA,86.0,M,"ON 2/10/2021- Resident with wife and he felt like he was going to pass out, became silent and arms began to shake and then his dead went back and he began snoring. He was unresponsive for two minutes. While nurse was there to follow up he felt like he was going to pass out. He became silent again, but nurse kept talking to him. His legs began shaking uncontrollably. He remained alert with this episode.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/04/2021,02/10/2021,6.0,SEN,Aspirin 81mg daily / Lisinopril 10mg daily / Donepezil 10mg daily / Vitamin D 1000iu daily / docusate sodium 100mg daily / Omega-3 100mg daily / mealtonin 5mg Ohs / lantanoprost drops daily,None known,Vitamin D def./ constipation / glaucoma/ GERD / hypertension / dementia /,,Sulfa and Penicillin,"['Computerised tomogram head normal', 'Dizziness', 'Dyskinesia', 'Electroencephalogram normal', 'Magnetic resonance imaging brain normal', 'Posture abnormal', 'Snoring', 'Tremor', 'Unresponsive to stimuli']",1,MODERNA, 1030557,PA,69.0,F,"According to her husband, approximately 3 hours after vaccine, patients clasped and was instantly unconscious. She was pronounced dead upon arrival to hospital and physician told husband that she had suffered a burst abdominal aneurysm and passed immediately. Nothing was out of ordinary during vaccination and during 15 minute wait time after.",Yes,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/10/2021,0.0,PHM,Losartan/HCTZ 100/25mg Alendronate Sodium 70mg,none,Hypertension,,none,"['Aortic aneurysm rupture', 'Death', 'Loss of consciousness', 'Syncope']",1,MODERNA,IM 1030586,PA,65.0,M,"This individual's employer informed our facility that he passed away at his home on 2/14/2021. Since he was not brought into our hospital, we do not have information regarding other health conditions or active medications. Since this individual received his second covid vaccine three days prior, this was reported to Moderna in addition to this VAERS report being completed. The coroner for County can be contacted.",Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,,02/11/2021,02/14/2021,3.0,PVT,,,,,,['Death'],2,MODERNA,ID 1030599,WY,84.0,M,"Systemic: Flushed / Sweating-Mild, Systemic: Other- Death-Severe",Yes,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/22/2021,4.0,SEN,,,,,,"['Death', 'Flushing', 'Hyperhidrosis']",1,PFIZER\BIONTECH,IM 1030637,IL,71.0,M,"about 30 hours after first dose of covid 19 vaccine, the patient had a bad stomach aches and diarrhea for an hour. after that he went into anaphylatic shock-had itching, hives all over body, his tongue swelled up, and he couldnt talk. he went to the ER and received benadryl, decadron, and fluids",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/25/2021,01/26/2021,1.0,PHM,"gabapentin, crestor, baby aspirin, flomax, lorazepam, omega 3",none,"high cholesterol, enlarged protate, diverticulitis, disc issue",,none,"['Abdominal pain upper', 'Anaphylactic shock', 'Aphasia', 'Diarrhoea', 'Pruritus', 'Swollen tongue', 'Urticaria']",1,MODERNA,IM 1030666,CA,77.0,F,"This event , because so many elderly people have the fillers in their knees should be widely publicized! We have fillers that help so much to be able to walk without pain, but this vaccine has caused me to have extreme pain and burning and not be able to walk without pain for 4 days now. NO ONE has said anything about how this Moderna vaccine would affect us because of the Hyaronolic Acid injections to our knees. We should have been allowed to get Pfizer!!!! I am so upset about this and extremely disappointed in our government's lack of disclosure.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/07/2021,02/10/2021,3.0,PVT,thyroid medication,none,knee pain for which I receive Hyarolonic Acid injections,,"many allergies to antibiotics, side effects from OTC anti inflammatories","['Burning sensation', 'Discouragement', 'Gait inability', 'Inflammation', 'Pain', 'Swelling']",1,MODERNA,IM 1030682,VA,39.0,F,"at 4:00 am on 2/14 (14 hours after shot)woke up to injection sight rash 3 inch wide, swollen and red fast heart rate 184 , chest pain and fast breathing was addmited to hospital hospital didn't mention vaccine on the hospital visit i have no heart issues prior to this.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/13/2021,02/14/2021,1.0,PUB,vitamin D probiotic,,,,,"['Blood test', 'Chest X-ray', 'Chest pain', 'Echocardiogram', 'Electrocardiogram', 'Heart rate increased', 'Injection site erythema', 'Injection site rash', 'Injection site swelling', 'Respiratory rate increased', 'Ultrasound scan']",2,MODERNA,SYR 1030693,NC,64.0,F,extreme swelling and severe pain in both wrists/ hands starting 2/7/21.seen in urgent care 2/8/21 and admitted through ER on 2/10/21. Inpatient for 3 days. IV antibiotic DC'd when blood cultures negative. Ultrasound left arm negative for DVT. Seen by Infectious Disease and he felt it was due to covid vaccine reaction. Started on steroid,Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/05/2021,02/07/2021,2.0,PVT,"protonix, celexa, losartan, vesicare MVI, Vit D3, red yeast rice, calcium, glucosamine",none,"hypertension, osteoarthritis",,"lisinopril, amlodipine, zithromax","['Arthralgia', 'Blood culture negative', 'Blood test', 'Joint swelling', 'Pain in extremity', 'Peripheral swelling', 'Ultrasound scan normal', 'X-ray']",2,PFIZER\BIONTECH,IM 1030701,FL,76.0,F,"unknown, husband reported hospitalization 02/12 and deceased 02/15",Yes,02/15/2021,Not Reported,Yes,4.0,Not Reported,N,02/08/2021,02/12/2021,4.0,PHM,"pregabalin, metoprolol succ, losartan, rosuvastatin, furosemide, duloxetine, Eliquis, ferrex, diltiazem, latanoprost",,,,,['Death'],1,MODERNA,IM 1030712,MI,74.0,M,"2/10: Fever, fatigue, tylenol 2/11 @ 1300: pt made DNR, hospice consulted 2/11 @ 1800 decreased LOC, increased RR, fever, chills - 1/5L NS bolus IV, rectal tylenol. Refusing to eat/drink, PO morphine 2/12 @ 16:30, deceased at facility **resident was not doing well prior to vaccination",Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/10/2021,1.0,SEN,,"In the hospital one week prior to vaccination for decreased LOC, and lack of appetite","non-Hodgkin lymphoma, epilepsy, advanced dementia, SDH, depression, COVID-19, malnutrition",,NKDA,"['Chills', 'Death', 'Decreased appetite', 'Depressed level of consciousness', 'Fatigue', 'Food refusal', 'Loss of consciousness', 'Pyrexia', 'Respiratory rate increased']",2,MODERNA,IM 1030729,AZ,79.0,M,"deceased, 2/1/21",Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,02/01/2021,17.0,UNK,"clopidogrel, levothyroxine, glipizide",,kidney,,,['Death'],1,PFIZER\BIONTECH,SYR 1030735,MI,79.0,F,"2/10: fatigue 2/12 @ 1900: SOB, wheeze, rhonchi, decreased SpO2. Tylenol, 2L NC applied, duoneb, IM Solumedrol, ST CXR, mucinex 2/12 @ 22:00 SpO2 70's, transfer to Hospital via EMS @ 22:30",Not Reported,,Not Reported,Yes,,Not Reported,U,02/09/2021,02/10/2021,1.0,SEN,,chronic cough and sputum,"COPD, emphysema, DM, OSA, CKD stage 3, SDH, HA",,Demerol,"['Chest X-ray', 'Dyspnoea', 'Fatigue', 'Oxygen saturation decreased', 'Rhonchi', 'Wheezing']",2,MODERNA,IM 1030787,IL,67.0,M,"Pt admitted from home with intermittent nausea, dry heaving, and central chest pressure which self resolve in 2 minutes since 2/6/21. Called 911 on 2/12/21 due to sustained episode that did not resolve. EMS treated with aspirin and nitroglycerin prior to arrival to ED. In ED patient became unresponsive and went into full cardiac arrest -CPR and ACLS care initiated. STEMI with AV conduction block. 2nd degree a-v block type II - significant bradycardia - temoprary pacemaker placed - Vfib -PEA. Time of death 0955 on 2/12/21 Patient recieved first dose of Moderna Covid vaccine on 2/4/21",Yes,,Not Reported,Not Reported,,Not Reported,,02/04/2021,02/06/2021,2.0,PVT,"Allopurinol 300mg PO daily, Simvastatin 10mg qhs",,"tubolovillous adenoma, chronic kidney disease, gout, hyperlipidemia, hx of kidney stone.",,No known drug allergies,"['Acute myocardial infarction', 'Atrioventricular block second degree', 'Bradycardia', 'Cardiac arrest', 'Cardiac pacemaker insertion', 'Chest discomfort', 'Death', 'Echocardiogram abnormal', 'Electrocardiogram ST segment elevation', 'Nausea', 'Pulseless electrical activity', 'Resuscitation', 'Retching', 'Unresponsive to stimuli', 'Ventricular fibrillation', 'Ventricular hypokinesia']",1,MODERNA, 1030805,MI,76.0,F,"2/10: fatigue, fever, decreased appetite. Tylenol 2/11: mental status wax/wane, lethargic 2/13 @ 0900: unresponsive to sternal rub, increased WOB, tachycardic, febrile D5 1/2 NS IV bolus, Rocephin Transferred to Hospital 2/13",Not Reported,,Not Reported,Yes,,Not Reported,U,02/09/2021,02/10/2021,1.0,SEN,,"pneumonia, elevated valproic acid level","HTN, seizures, dementia, PEG tube",,NKDA,"['Body temperature increased', 'Decreased appetite', 'Dyspnoea', 'Fatigue', 'Lethargy', 'Mental status changes', 'Pyrexia', 'Tachycardia', 'Unresponsive to stimuli']",2,MODERNA,IM 1030843,AZ,,U,"other zoster-related conditions; shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was provided regarding medical history, concurrent condition, or concomitant medication. On an unknown date in 2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose number and route was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date (reported as ""subsequent to zoster vaccine live (ZOSTAVAX) inoculation""), the patient was treated by a physician for shingles and other zoster-related injuries. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome the events was not provided. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,OTH,,,,,,['Herpes zoster'],UNK,MERCK & CO. INC.,OT 1030850,NE,23.0,F,"Twitching of the face; Syncope; Weakness; A spontaneous report was received from a pharmacy intern, concerning a 23-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced syncope, weakness, and twitching of the face. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Dec 2020, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. On 31 Dec 2020, the patient was working and experienced syncope and weakness. On 06 Jan 2021, the patient reported experience twitching of the face beginning on an undisclosed date and she also continued to experience weakness. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, syncope, was unknown. The events, weakness and twitching of the face, were considered not resolved.; Reporter's Comments: This case concerns a 23-year-old, female, who experienced serious unexpected event of syncope, and non-serious unexpected events of asthenia and muscle twitching. The events of syncope, asthenia occurred 2 days after mRNA-1273 (Lot# 025J20-2A), while the event of muscle twitching occurred on an unspecified date after mRNA-1273 (Lot# 025J20-2A). Treatment details were not provided. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Asthenia', 'Muscle twitching', 'Syncope']",1,MODERNA,OT 1030851,,,M,"Swelled up badly from it, my face was swollen and my arms and my back and my chest; Red upper body; A spontaneous report was received from a consumer who was also a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced swollen up badly in the face, neck, arms, back and chest, and redness on whole upper body. The patient's medical history was not provided. Concomitant product use was not provided. On 15 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The patient reported that on 16 Jan 2021 he bad swelling in the face, neck, arms, back and chest and redness on whole upper body. Treatment for the event included an emergency room visit with hospitalization and steroids on 17 Jan 2021. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, experienced swollen up badly in the face, neck, arms, back and chest and redness on whole upper body, was considered unknown.; Reporter's Comments: This case concerns a male patient, who experienced serious unexpected event of swelling (face, neck, arms, back and chest) and non-serious unexpected event of erythema (upper body). The event occurred 2 days after mRNA-1273 (Lot# Unknown). Treatment included steroids. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/15/2021,01/16/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history provided),,,"['Erythema', 'Swelling']",1,MODERNA,OT 1030852,,,U,"Died; A spontaneous report was received from a reporter concerning a unknown patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed away. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient passed away. No treatment information was provided. Action taken with RNA-1273 in response to the event was not applicable. The patient died on unknown date. The cause of death was reported as unknown. Autopsy details were unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender. The patient's medical history was not provided. The fatal, unexpected event of death occurred on an unknown date after the administration of the first dose of mRNA-1273 on an unknown date. The cause of death was reported as unknown. Autopsy details were unknown. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the event, a causal relationship cannot be excluded. Additional information regarding the autopsy report, date of the mRNA administration, day of death, medical information and details of concomitant product are all required for further assessment of causality.; Reported Cause(s) of Death: Unknown cause of death",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Death'],1,MODERNA,OT 1030853,WA,86.0,M,"Parkinson is worse since the vaccine; both hands shaking; Is itchy in all my boy, still itchy; A spontaneous report was received from a healthcare professional who a 86 year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itching all over my body and Parkinson's is worse since the vaccine. The patient's medical history included Parkinson's disease. Products known to have been used by the patient, within two weeks prior to the event, included pramipexole. On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) in the left arm intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, two days post vaccination, the patient reported he had itching all over his body. He was unable to sleep without taking diphenhydramine due to the itching. On unknown date, the patient also states he thought the vaccine made his Parkinson's worse. He reported both of his hands had been shaking since he received the vaccine. Treatment for the event included diphenhydramine and pramipexole. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events itching all over my body and Parkinson's is worse since the vaccine, were considered unknown.; Reporter's Comments: This case concerns an 86-year-old, male, with medical history of Parkinson's disease, who experienced a serious event of Parkinson's disease aggravated after receiving first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Follow-up information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/22/2021,2.0,UNK,PRAMIPEXOLE,Parkinson's disease,,,,"[""Parkinson's disease"", 'Pruritus', 'Tremor']",1,MODERNA,OT 1030854,CA,,F,"COVID; Pneumonia; acute appendicitis; low grade fever; headache; muscle aches; congestion; under the weather; fatigued; extremely cold and had chills; cough; Redness; arm swelling; Soreness; slight dizziness; A spontaneous report was received from a consumer who was also an approximately 56-year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced dizziness, redness (vaccination site erythema), arm swelling (vaccination site swelling), soreness (vaccination site pain), cough, fatigue, under the weather (malaise), extremely cold and had chills (chills), headache, congestion (lower respiratory tract congestion), muscle aches (myalgia), low grade fever (pyrexia), COVID (COVID-19), pneumonia, and acute appendicitis. The patient's medical history was not reported. Concomitant product use included lisinopril, ergocalciferol, colecalciferol/ magnesium oxide/ vitamin B1, and ascorbic acid. On 08 Jan 2021, approximately hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number 037C20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 08 Jan 2021 after receiving the first dose of Moderna COVID-19 vaccine, the patient had slight dizziness, redness, arm swelling and soreness which all went away by 10 Jan 2021. On 10 Jan 2021 she had one cough which was nothing to be alarmed about. On 11 Jan 2021 she started to feel fatigued, under the weather, extremely cold and had chills. On 12 Jan 2021 the patient's workplace had her take a COVID test, which came back positive on 13 Jan 2021. Additionally, on 12 Jan 2021, the patient started to get a headache, congestion, was still super cold and had the chills and muscle aches. She went to a respiratory medical doctor who administered a chest x-ray and told the patient it all looked fine. On 13 Jan 2021, she had a low grade fever of around 100.1 degrees Fahrenheit. The following Sunday, 17 Jan 2021, the patient had abdominal pain. She went to the emergency department (ED) where they did another chest x-ray and it showed she had pneumonia. The patient also ended up having an appendectomy (date not reported). Treatment medications included ibuprofen for pain from the surgery and guaifenesin for congestion. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events low grade fever, headache, chills, fatigue, under the weather, congestion, COVID, and pneumonia, was unknown. The outcome, of the events soreness, swelling, redness, cough, and dizziness, was considered recovered/resolved on 10 Jan 2021. The outcome of the event, muscle aches, was considered recovered/resolved on 13 Jan 2021. The outcome of the event, appendicitis, was considered resolved on an undisclosed date.; Reporter's Comments: This case concerns a 56-year-old female with serious unexpected events of abdominal pain, appendicitis, COVID-19, pneumonia and unexpected events of cough, bronchial congestion, malaise, dizziness. Cough onset day 2 after first dose mRNA-1273, with COVID-19 day 5 and hospitalization for pneumonia and appendicitis day 10. Based on the current available information and temporal association between the use of the product and the start date of some events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,LISINOPRIL; VITAMIN D NOS; MAGNESIUM 400; VITAMIN C [ASCORBIC ACID],,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Appendicitis', 'COVID-19', 'Chest X-ray', 'Chills', 'Cough', 'Dizziness', 'Fatigue', 'Headache', 'Lower respiratory tract congestion', 'Malaise', 'Myalgia', 'Pneumonia', 'Pyrexia', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",1,MODERNA,OT 1030858,,,U,"pnuemonia; flu; Initial information was received on 22-Nov-2020 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient) via social media. This case involves adult patient (age and gender not specified) who had flu (influenza) and pnuemonia, while patient received INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE Medical history, medical treatment(s), past vaccination(s) concomitant medication, concomitant disease and family history or risk factor were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer and PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious flu (influenza) and pneumonia (unknown latency) following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE. The patient was ended up in intensive care unit for a week and assessed as medically significant for pneumonia event. It is unknown if the patient experienced any additional symptoms/events. Patient should have listened to gut instinct and not trust them. Each individual is different genetically. It affected patient adversely. Never again. The same with the rona vaccine. There were no lab data/results available. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event was unknown for both events. There will be no information available on the batch number for this case.; Sender's Comments: This case concerns adult patient who had influenza and pnuemonia after vaccination with INFLUENZA VACCINE (unknown manufacturer) and PNEUMOCOCCAL VACCINE .The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,"['Influenza', 'Intensive care', 'Pneumonia']",UNK,UNKNOWN MANUFACTURER,OT 1030860,,,U,"two patient died after vaccination with INFLUENZA; Initial information received on 10-Feb-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional. This case involves two patients (unspecified age and gender) who died after receiving INFLUENZA VACCINE (death). The medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, two patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, two patients died after vaccination with INFLUENZA (death) unknown latency following the administration of INFLUENZA VACCINE.. The event was also assessed as medically significant. It was unknown if the patients experienced any additional symptoms/events. It was unknown if there were lab data/results available. It was not reported if the patients received a corrective treatment before death. An autopsy was not done and the actual cause of death was not reported at the time of reporting. The reporter could not provide any other information about the case. Information on the batch number was requested.; Sender's Comments: This case concerns two patients (unspecified age and gender), who died after vaccination with INFLUENZA VACCINE (death) (produced by unknown manufacturer). The time to onset was unknown. However, patients medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: lost 2 friends who took it",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],UNK,UNKNOWN MANUFACTURER,OT 1030893,WI,92.0,F,"Resident had slight/slow decline in health prior to vaccine but continued to be able to walk around with walker at community. The day of the vaccine she had a fever. 2 days after vaccine resident did not get out of bed all day and refused to eat. She had small amounts of orange juice as her blood sugar level was low due to not eating. Resident was diagnosed with a UTI and began an oral antibiotic. 3 days after and on day 5 after vaccine resident began feeling weak and had a fall on each day. The following day again resident spent the day in bed. The next day she was quite restless, was on the edge of her bed attempting to self transfer often throughout the day. Resident continued to be restless on the 10th of Feb, had further decline on the 11th of Feb. Resident passed away early the AM of Feb. 12th.",Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/10/2021,7.0,SEN,"Acetaminophen, amlodipine, atorvastatin, clonazepam, furosemide, guaifenesin DM",Resident had a low grade fever day of vaccine and was not feeling well. Pharmacy stated it would be ok to have vaccine and administered in resident's room.,"Osteoporosis, type 2 diabetes, vitamin B deficiency, anxiety, achalasia of cardia, GERD, iron deficiency, atrial fibrillation, chronic kidney disease",,Fluoxetine and Metformin,"['Asthenia', 'Death', 'Decreased appetite', 'Fall', 'Food refusal', 'General physical health deterioration', 'Mobility decreased', 'Pyrexia', 'Restlessness', 'Urinary tract infection', 'Walking aid user']",1,PFIZER\BIONTECH,IM 1030963,KY,86.0,M,"sudden onset and progressive worsening generalized weakness with nausea and vomiting, fever",Not Reported,,Not Reported,Yes,,Not Reported,U,02/13/2021,02/13/2021,0.0,PVT,,,,,,"['Asthenia', 'Nausea', 'Pyrexia', 'Vomiting']",2,MODERNA,IM 1031025,IN,86.0,M,Patient told doctor that his blood sugar went up (>400) after his first COVID-19 vaccine and he was hospitalized.,Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/18/2021,01/18/2021,0.0,OTH,unknown,Unknown,Diabetes,,unknown,"['Blood glucose increased', 'Condition aggravated']",1,MODERNA,IM 1031459,,,F,"Vision not clear; Pounding of chest; throat felt contracted; A report was received from a healthcare professional concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced vision not clear, pounding of chest, and throat felt contracted. The patient's medical history, as provided by the reporter, included asthma and hypoglycemia. No relevant concomitant medications were reported. On 30 Dec 2020, approximately 15 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 30 Dec 2020, 15 minutes following vaccine administration, the subject's vision became unclear, and she described everything seeming hazy and smoky. Her throat then began to feet contracted and her chest was pounding. The patient was transported to the emergency room (ER) via an ambulance. Her electrocardiogram (EKG) result was normal, while blood pressure and blood sugar results were increased. She remained in the ER overnight but was not admitted. Her vision returned to normal 5 pm the same day. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The event, vision not clear, was considered resolved on 30 Dec 2020. The outcome of the events, pounding of chest, and throat felt contracted were unknown. The reporter did not provide an assessment for the events, vision not clear, pounding of chest, and throat felt contracted.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The Patient's medical history of asthma and hypoglycemia remains as confounders.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,UNK,,Asthma; Hypoglycemia,,,,"['Electrocardiogram', 'Heart rate increased', 'Throat tightness', 'Visual impairment']",1,MODERNA,OT 1031460,CA,77.0,F,"Convulsing; Mild diarrhea; Fatigue; Mild bladder infection; Sweating; Pain; Fever; Nausea; Chills; A spontaneous report was received from a consumer concerning a 77-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced pain, fever, nausea, chills, convulsing, uncontrollable body jerking, sweating, full body ache, fatigue, and mild diarrhea. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 15 Jan 2021, approximately the night of prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 011L20A) intramuscularly for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient developed pain, fever, nausea and chills. On 16 Jan 2021, the patient entire body started convulsing and sweating. She developed pain; entire body ached with uncontrollable body jerking. Patient was taken to the hospital, where she received intravenous fluid and paracetamol and was diagnosed with a very mild bladder infection. On an unknown date, the patient had mild diarrhea and fatigue. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events pain, fever, nausea, chills, convulsing, uncontrollable body jerking, sweating, full body ache, diarrhea, and fatigue was not reported.; Reporter's Comments: This case concerns a 77 year old, female patient, who experienced serious unexpected event of seizure, and non-serious unexpected event of hyperhidrosis and cystitis, and non-serious expected events of nausea, pyrexia, chills, diarrhea and fatigue. The event of pain, pyrexia, nausea, chills occurred 1 day (same day) date after mRNA-1273 (Lot# 011L20A), while the event of seizure, hyperhidrosis, and cystitis occurred 2 day (same day) date after mRNA-1273 (Lot# 011L20A). The event of diarrhea and fatigue occurred on an unspecified date after mRNA-1273 (Lot# 011L20A). Treatment included IV fluids and Tylenol. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/15/2021,01/15/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Chills', 'Cystitis', 'Diarrhoea', 'Fatigue', 'Hyperhidrosis', 'Nausea', 'Pain', 'Pyrexia', 'Seizure']",1,MODERNA,OT 1031461,CA,,F,"Numbness of face, tongue, throat; Tingling of face, tongue, throat; A spontaneous report was received from a health care professional concerning a 60-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness and tingling of face, tongue and throat. The patient's medical history was Rheumatoid arthritis, hypertension and possible allergy to diphenhydramine and meperidine. No relevant concomitant medications were reported. On 13 Jan 2021 at 10:11 A.M., prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 13 Jan 2021 at 10:15 A.M., after receiving the vaccine, patient started to experience numbness and tingling of face, tongue and throat. Initial examination included lungs angiogram, which indicated regular tachycardia. Findings included swelling of lips and tongue, and uvula midplane, not deviated. The patient was moved on an observation area. Emergency medical services (EMS) were notified. Intramuscular (IM) epinephrine was administered at 10:23 A.M. At 10:25 A.M. the patient's vital signs included blood pressure 185/87, heart rate 128, respiratory rate 20, and oxygen saturation 100%. A second IM epinephrine treatment was given at 10:26 A.M. At 10:29 A.M. the patient's vital signs included blood pressure 185.87, heart rate 134, and oxygen saturation 100%. At 10:29 A.M. treatment included oral diphenhydramine. Next dose of IM epinephrine failed; a fourth dose was given at 10:35 A.M. At 10:45 A.M., EMS arrived, and the patient was taken to the emergency room. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, numbness and tingling of face, tongue and throat was unknown.; Reporter's Comments: This case concerns a 60 year-old, female patient, who experienced events of numbness and tingling of face, tongue and throat. The events occurred within minutes after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/13/2021,0.0,UNK,,,"Medical History/Concurrent Conditions: Drug allergy (Possible allergy, Demerol); Drug allergy (Possible allergy, Benadryl); Hypertension; Rheumatoid arthritis",,,"['Blood pressure measurement', 'Heart rate', 'Hypoaesthesia', 'Oxygen saturation', 'Paraesthesia', 'Physical examination', 'Respiratory rate']",1,MODERNA,OT 1031462,CA,56.0,F,"Periorbital swelling; Generalized facial edema; Oropharyngeal edema; Felt faint; Tingling lip; Facial redness; Appears pale; A spontaneous report was received from a healthcare professional concerning a 56-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lower lip tingling, pale in color, periorbital and generalized facial edema and facial redness. The patient's medical history was not provided. No concomitant product use was reported. On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) in the left arm intramuscularly for prophylaxis of COVID-19 infection. On 13 Jan 2021, at 0845, 7 minutes after receiving the Moderna COVID-19 vaccine, the patient arrived for observation at urgent care. The patient stated she felt faint and her lip was starting to ""feel swollen"" and tingling. Initial vital signs were: blood pressure � 147/79, heart rate � 69, respirations � 20 and oxygen saturation � 99 percent. A nurse practitioner and doctor evaluated the patient and noted patient had oropharyngeal edema and lungs were clear to auscultation (CTA). At 0851, diphenhydramine 25 milligrams orally was given with no effect. Facial redness and edema worsened. At 0855, epinephrine 3 milligrams was given with improvement, but after 5 minutes, facial redness and lower lip worsened. At 0902, a second dose of epinephrine was given. At 0903, vital signs were: blood pressure � 162/87, heart rate � 104, respirations � 20 and oxygen saturation � 100 percent on 4 liters of oxygen. Facial redness and edema improved but still had swelling and tingling of lower lip. At 0909, emergency medical services (EMS) were called and patient was transported to emergency room/department. Treatment for the event included diphenhydramine, epinephrine and oxygen. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, lower lip tingling, pale in color, periorbital and generalized facial edema and facial redness, were considered unknown.; Reporter's Comments: This case concerns a 56-year-old, female patient. The patient's medical history was not provided. The patient experienced serious, unexpected event of periorbital swelling, facial swelling, oropharyngeal edema and unexpected events of Paraesthesia oral, erythema, pallor and dizziness. The events occurred 8 minutes after the first dose of mRNA-1273 (Lot number: 041L20A) administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/13/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Blood pressure measurement', 'Dizziness', 'Erythema', 'Heart rate', 'Oropharyngeal oedema', 'Oxygen saturation', 'Pallor', 'Paraesthesia oral', 'Periorbital swelling', 'Respiratory rate', 'Swelling face']",1,MODERNA,OT 1031463,CA,,F,"Anaphylactic reaction; A spontaneous report was received from a healthcare professional concerning a 24-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Anaphylactic reaction. The patient's medical history included allergy to milk. No concomitant medications were reported. On 12 Jan 2021, 5 � 10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in an unknown arm for prophylaxis of COVID-19 infection. The patient experienced chest tightness and tachycardia symptoms following which she was transported via gurney to the observation area. The patient looked sleepy and had trouble arousing her. The blood pressure was at 140/80 mmHg, heart rate was in the 90s to 100s heartbeats per minute. The patient's breath sound decreased bilaterally. It was also noted that her throat felt uncomfortable. The reporter stated that anaphylaxis reaction was suspected due to the rapid decline in status. Following an increasing heart rate and complaints of chest discomfort the patient was treated with a dose one of epinephrine pen. It was noted after a minute or two the patient's chest felt better. Her blood pressure was stable at 140/80's mmHg, the heart rate initially increased to 110 and then back down to 100 about 5 minutes after the first dose. At about 8 minutes from dose one of epinephrine pen, the patient's heart rate increased to 160 and developed additional symptoms of chest tightness again so a second dose of Epinephrine pen was administered. The patient was somnolent but protecting airway. Oxygen was added 2 liters after second dose of epinephrine pen. The patient's oxygen saturation dropped right around second dose of epinephrine pen to 94% but about 2-3 minutes later it was back at 98%. The paramedics arrived 5 minutes after second dose of epinephrine pen and care was transferred to them. The patient was transported in a stable condition. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the Anaphylactic reaction was unknown.; Reporter's Comments: This case concerns a 24 year old, female patient, who experienced serious unexpected event of Anaphylactic reaction. The event occurred 1 day (5-10 min) after mRNA-1273 (Lot# Unknown). Treatment included EpiPen (2 doses). Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/12/2021,0.0,UNK,,Allergy to cow's milk,,,,"['Anaphylactic reaction', 'Blood pressure measurement', 'Heart rate', 'Oxygen saturation']",1,MODERNA,OT 1031464,,31.0,F,"Anaphylaxis; Hives; A spontaneous report was received from a healthcare professional concerning a 31-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis and hives. The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 Jan 2021 at 4:50 pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection. On 11 Jan 2021 at 4:50 pm, after receiving the vaccine, the patient experienced anaphylaxis and hives. She was given epinephrine and 50 mg of diphenhydramine. Emergency Medical Services (EMS) and the fire department were called. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, anaphylaxis and hives, were unknown.; Reporter's Comments: This case concerns a 31 year old, female patient, who experienced serious unexpected event of Anaphylactic reaction, a non-serious unexpected event of urticaria. The event occurred 1 day (few min) after mRNA-1273 (Lot# Unknown). Treatment included EpiPen. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/11/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Anaphylactic reaction', 'Urticaria']",1,MODERNA,OT 1031465,,,F,"seizure; signs of confusion; Fever; shoulder pain; A spontaneous report was received from a husband, concerning a 26-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shoulder pain, fever, signs of confusion and a seizure. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received the first of two planned doses of mRNA-1273 intramuscularly (lot number: unknown). On 29 Jan 2021, the patient received the second of two planned doses of mRNA-1273 intramuscularly (lot number: unknown) for prophylaxis of COVID-19 infection. On 29 Jan 2021, the patient's husband reported that patient experienced shoulder pain, 10-12 hours later the patient started to have a fever. On 30 Jan 2021, the patient had signs of confusion and then suffered a seizure and was taken to the hospital. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the events, shoulder pain, fever, signs of confusion and a seizure, were unknown.; Reporter's Comments: This case concerns a 26-year-old, female patient, who experienced a serious unexpected event of Seizure, non-serious unexpected event of Confusional state, and non-serious expected events of Pyrexia and Arthralgia. The events of Pyrexia and Arthralgia occurred on the same day after second of two planned doses of mRNA-1273, lot # unknown. The events of Seizure and Confusional state occurred approximately 2 days after second of two planned doses of mRNA-1273, lot # unknown. Treatment information is not provided. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/29/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Arthralgia', 'Confusional state', 'Pyrexia', 'Seizure']",1,MODERNA, 1031466,CA,72.0,F,"Minor stroke; Weak muscles; Terible pain in neck and lower back; Terible pain in neck and lower back; Nerve pain; Achy; Injection site reaction; A spontaneous report was received from a consumer who was also a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced C, injection site reaction, and achy. The patient's medical history was not provided. Concomitant medications were not reported. On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 043L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 21 Jan 2021, after vaccine administration, the patient experienced injection site reaction. On 22 Jan 2021, she was feeling achy. On 23 Jan 2021, she had nerve pain that felt like cutting on the back, legs, and arms. On 24 Jan 2021, the patient's muscles were weak and were not working or responsive on both sides. On 25 Jan 2021, the patient could not control her left hand and weakness was more predominant on left side. The patient went to the doctor and was hospitalized with minor stroke for 24 hours. The patient stated that she was still experiencing terrible pain in neck and lower back. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, minor stroke, weak muscles, nerve pain, injection site reaction, and achy, was unknown. The outcome of event, terrible pain in neck and lower back, was considered not resolved.; Reporter's Comments: Based on the current available information and evidence of a temporal association between mRNA-1273 use and the onset of injection site reaction and achy, a causal relationship cannot be excluded. There is limited information to asses causality for the events of injection site reaction, and achy. Additional information has been requested.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/21/2021,01/21/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Asthenia', 'Back pain', 'Cerebrovascular accident', 'Injection site reaction', 'Neck pain', 'Neuralgia', 'Pain']",1,MODERNA,OT 1031471,,,M,"Tested positive for COVID-19; Feels very ill; Feeling tired; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced feeling tired, feeling very ill, and tested positive for COVID-19. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 07 Jan 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 08 Jan 2021, the patient felt tired and sick. On 13 Jan 2021, the patient was admitted to the hospital where he tested positive for COVID-19. He felt very ill. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events was not reported.; Reporter's Comments: This spontaneous report concerns a male patient who experienced feeling tired, feeling very ill, and tested positive for COVID-19. The events of feeling tired, feeling very ill started one day after the administration of mRNA-1273 vaccine (Lot number: unknown, expiration date: unknown) and 6 days after the vaccine administration, the patient tested positive for COVID-19. Based on the information provided, the known etiology of the disease and the timing from vaccine administration to COVID diagnosis, a causal association between the reported events and mRNA-1273 vaccine administration is unlikely.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/07/2021,01/08/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['COVID-19', 'Fatigue', 'Malaise', 'SARS-CoV-2 test']",1,MODERNA,OT 1031482,NY,,F,"Patient fainted; Migraine; Shortness of breath; Felt very tired; Fever; A spontaneous report was received from a consumer who was also a 34-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced fainting (syncope), migraine, shortness of breath (dyspnoea), fever (pyrexia), and felt very tired (fatigue). The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included fexofenadine hydrochloride and birth control. On 17 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A) intramuscularly in right arm for prophylaxis of COVID-19 infection. On 18 Jan 2021, the patient fainted. She felt very tired, had migraine, fever, and shortness of breath. The symptoms continued on and off. Treatment for the event included paracetamol. Action taken with mRNA-1273 in response to the events was not provided. The outcomes of the events fainted, migraine, shortness of breath, fever, and felt very tired, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the reported events, a causal relationship cannot be excluded. Fever and fatigue are consistent with the known safety profile of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/17/2021,01/18/2021,1.0,UNK,ALLEGRA,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Dyspnoea', 'Fatigue', 'Migraine', 'Pyrexia', 'Syncope']",1,MODERNA,OT 1031483,TN,75.0,F,"body is very sore; severe chill rigors; couldn't get out of the bed because the rigors were so intense that legs would not support her; a slight fever; This is a spontaneous report from a contactable consumer reported for herself. A 75-years-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 30Jan2021 11:30 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included venlafaxine, levothyroxine, diclofenac, gabapentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the 1st dose of BNT162B2 on 09Jan2021 11:30 AM for covid-19 immunization. Initially the patient noticed a slight fever 11 hours after vaccine on 31Jan2021. Then about 12 hours after her vaccine on 31Jan2021, she had severe chill rigors for about 2.5 hours. She couldn't get out of the bed because the rigors were so intense that her legs would not support her. On 31Jan2021 12:00 AM, (12 hours after the rigors), her entire body was very sore, feeling as if she had been run over by a truck. No treatment received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/31/2021,1.0,PUB,VENLAFAXINE; LEVOTHYROXINE; DICLOFENAC; GABAPENTIN,,,,,"['Chills', 'Dysstasia', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1031484,UT,73.0,F,"Dizziness with very high blood pressure 193/94; Major Headache; Dizziness with very high blood pressure 193/94; shakiness; This is a spontaneous report from a contactable consumer (patient) reported for that a 73-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982) , via an unspecified route of administration on 30Jan2021 14:30 at single dose at right arm for covid-19 immunisation. Medical history included blood pressure. Concomitant medication included pantoprazole, metoprolol, atorvastatin, metformin. The patient previously took Cefdinir and experienced allergy. The patient experienced dizziness with very high blood pressure 193/94, also shakiness, major headache on 30Jan2021 16:30. Adverse event result doctor or other healthcare professional office/clinic visit. The patient had EKG. Therapeutic measures were taken as a result of events included unspecified medication. The outcome of events was recovered with sequelae. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,PUB,PANTOPRAZOLE; METOPROLOL; ATORVASTATIN; METFORMIN,,Medical History/Concurrent Conditions: Blood pressure abnormal (blood pressure),,,"['Blood pressure measurement', 'Dizziness', 'Electrocardiogram', 'Headache', 'Hypertension', 'Tremor']",1,PFIZER\BIONTECH, 1031485,FL,68.0,F,"right side of face drooping, diagnosis Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: El8982), via an unspecified route of administration on 29Jan2021 09:00 at single dose on right arm for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot: El3246) received on 08Jan2021 at 03:00 pm on left arm for COVID-19 immunization. The patient experienced right side of face drooping, diagnosis as bell's palsy on 31Jan2021 06:00 with outcome of not recovered. Treatment received for the event included prescriptions. This event resulted in emergency room/department or urgent care. Patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/31/2021,2.0,UNK,,,,,,['Facial paralysis'],2,PFIZER\BIONTECH, 1031486,NY,45.0,F,"passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of back/torso, legs ached; tingling/severe pain shoulders and all of back/torso, legs ached; pain all over/torso; slight head ache; chills/cold; chills/cold; turned to temp 99.9; very warm/uncomfortable; fatigue; This is a spontaneous report from a non-contactable nurse (patient). This 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3249), via an unspecified route of administration on 29Jan2021 09:30 at single dose in the left arm for COVID-19 immunization. The patient's medical history was none. No known allergies. The patient's concomitant medications included naproxen (occasional) in two weeks. The patient previously took first dose of bnt162b2 (Lot number: EK9231), on 07Jan2021 at left arm for COVID-19 immunization. Facility type vaccine was hospital. No other vaccine received in four weeks. Patient got vaccine at 9:30am. Woke up morning (30Jan2021) after the vaccine about 9:30am with tingling/severe pain shoulders and all of back/torso, legs ached. During shower at that time, very close to vomiting/passing out. Took NSAID and slept. Then paracetamol (TYLENOL) mid day. That evening had fatigue and pain all over, slight head ache, chills/cold and then turned to temp 99.9, very warm/uncomfortable. Paracetamol again that night before bed. Woke on Sunday better just fatigue and achy. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was recovered in 2021. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,PVT,NAPROXEN,,,,,"['Arthralgia', 'Back pain', 'Body temperature', 'Chills', 'Discomfort', 'Fatigue', 'Headache', 'Loss of consciousness', 'Nasopharyngitis', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH, 1031487,PA,33.0,M,"spiked a fever of 101.3; spiked a fever of 101.3 which cause a 20 minute seizure; spiked a fever of 101.3 which cause a 20 minute seizure; headache; This is a spontaneous report from a contactable consumer reported for himself. A 33-years-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at right arm on 25Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included seizure disorder and other neurological issues, allergy to latex. Concomitant medication included levothyroxine sodium (SYNTHROID), fluoxetine hydrochloride (PROZAC), omeprazole, lacosamide (VIMPAT), lamotrigine (LAMOTRIGINE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included 1st dose of BNT162B2 (lot number: EK9231) on 04Jan2021 12:00 PM at left arm for COVID-19 immunization when he was 32-years-old. The patient had a headache throughout the following day and evening on 26Jan2021. On 27Jan2021 spiked a fever of 101.3 which cause a 20 minute seizure. He was hospitalized for 2 days. Events resulted in emergency room/department or urgent care, hospitalization. Treatment was received for the adverse event in hospital. The events outcome was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The report was reported as serious with seriousness criteria-caused hospitalization.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/25/2021,01/26/2021,1.0,PVT,SYNTHROID; PROZAC; OMEPRAZOLE; VIMPAT; LAMOTRIGINE,,Medical History/Concurrent Conditions: Latex allergy; Neurological disorder NOS; Seizure,,,"['Body temperature', 'Disease recurrence', 'Headache', 'Pyrexia', 'Seizure']",2,PFIZER\BIONTECH, 1031488,NC,72.0,M,"very sick/high fever/get weaker/diagnosed with double pneumonia; This is a spontaneous report from a contactable consumer (patient wife). A 72-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EL3247, intramuscular in left arm on 15Jan2021 (at 1500 or 1600) at single dose to prevent covid. There were no relevant medical history or concomitant medications. There were no additional vaccines administered on same date of the BNT162B2. There was no prior Vaccinations (within 4 weeks). The reporter stated on 16Jan2021 the patient got very very sick. He started running a fever, a high fever a high temperature all day on 16Jan2021 through 17Jan2021. On 17Jan2021 night the reporter took him to the emergency room and they said it was from the covid shot. The patient began to get weaker on 17Jan2021 (not resolved) and still with a fever (resolved in Jan2021) and they said it was the shot. They went to a walk in clinic where they did a covid test on 17Jan2021 which was negative and they gave him medicine for possible pneumonia. But he didn't get any better. They went to another clinic where he had 3 more tests on 17Jan2021, ""a covid test, a throat culture/ strep test and a flu test that all came back negative"". On 18Jan2021 his family doctor advised him to go the hospital and he was diagnosed with double pneumonia which was resolving. The reporter stated that the event required a visit to Emergency Room and Physician Office. The reporter wanted to know if he will be able to get the second shot and asking if the first dose of the covid vaccine give him pneumonia. The medicine they gave him did not seem to be doing a lot of good, he was admitted for 3 days last week (since Jan2021 to Jan2021) and he received iv antibiotics. The medicine that was not doing good she clarified was oral pills of azithromycin (Lot: KJ9712, Expiration: Jan2022. NDC: 0781808926)that was to be taken at home. The outcome of the event was not resolved.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/15/2021,01/16/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'Culture throat', 'Influenza virus test', 'Pneumonia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1031489,WA,69.0,F,"serious all-over body aches; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 13:15 at single dose in left arm for COVID-19 immunization. Medical history included Hypertension, allergies to Mango. Concomitant medication included lisinopril and colecalciferol (VITAMIN D). The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient had no immediate discomfort. No sore arm at all. But 2 days after the shot on 28Jan2021 18:00 she experienced serious all-over body aches. They were painful, and lasted about 30 hours. No treatment was received for the event. The outcome of the event was resolved. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/28/2021,2.0,PVT,LISINOPRIL; VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: Fruit allergy; Hypertension,,,['Pain'],UNK,PFIZER\BIONTECH, 1031490,FL,44.0,M,"Erectile dysfunction - trouble maintaining an erection; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 15Jan2021 13:30 at single dose in left arm for COVID-19 immunization. Medical history included Churg Strauss and vasculitis. The patient had no covid prior vaccination and did not had covid tested post vaccination. The patient had no known allergies. No other vaccine in four weeks. Concomitant medications included other medications in two weeks yes, but no changes to medication within months. The patient experienced erectile dysfunction - trouble maintaining an erection on 18Jan2021. No treatment was received. The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/18/2021,3.0,PVT,,,Medical History/Concurrent Conditions: Churg Strauss syndrome; Vasculitis,,,['Erectile dysfunction'],1,PFIZER\BIONTECH, 1031491,CA,,F,"experienced bleeding from her eyes and red blood circles around her eyes; bleeding internally; head breaking out in lumps and pustules and itching; head breaking out in lumps and pustules and itching; head breaking out in lumps and pustules and itching; she experienced a strange headache in the frontal area; she almost vomited; noticed a strong taste of chemicals; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at single dose for COVID-19 immunization. Medical history included poisoned with chemicals, sensitive to chemicals, thoracic aortic aneurysm and was taking the blood thinner for that reason. Concomitant medications included 14 prescription drugs including a blood thinner. The patient received the first dose of the Pfizer-Biontech Covid-19 vaccine on Thursday, 25Jan2021. About 20 minutes after the injection, she experienced a strange headache in the frontal area. While walking out of the clinic, she almost vomited and noticed a strong taste of chemicals. On Friday night, 26Jan2021, she experienced her head breaking out in lumps and pustules and itching. On Friday and Saturday, she experienced bleeding from her eyes and red blood circles around her eyes. The consumer thought she was bleeding internally. The outcome of all events was unknown. Information on Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/25/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Chemical poisoning (being poisoned with chemicals 4 times in the past); Chemical sensitivity; Thoracic aortic aneurysm,,,"['Dysgeusia', 'Eye haemorrhage', 'Headache', 'Internal haemorrhage', 'Mass', 'Pruritus', 'Pustule', 'Vomiting']",1,PFIZER\BIONTECH, 1031492,OH,78.0,F,"unconscious; no heart rate/heart was not beating; all of the sudden she stopped breathing and her heart stopped beating; COVID 19 test positive; act funny, kind of quiet and not talking which was unusual for her; pressure was 60 over 4; This is a spontaneous report from a contactable consumer (patient husband). A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318), via an unspecified route of administration on 28Jan2021 16:00 at single dose at left arm for covid-19 immunization. Medical history included kidney ablation (ablation on the kidney cancer 5 years ago), kidney cancer, blood pressure, neuropathy, pain, had a urinary tract infection 19Dec2020 and they saw the cancer came back, radiologist read the CAT Scan and said the size of the tumor 1.5 to 2.4. Concomitant medications included acebutolol for blood pressure taking for years, diclofenac for neuropathy using for 10 years, oxycodone for pain taking 19 years; all ongoing, and oxycodone hydrochloride (OXYCONTIN) for pain. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Family Medical History was none. The caller stated that he was not sure if the Pfizer COVID-19 vaccine could have given patient (his wife) COVID-19 or not. He also stated that when they received their vaccines the facility was very crowded as was the hospital when the wife was getting her blood work done so he was not sure when or where she contracted COVID-19. On 29Jan2021, patient was very busy running several errands including going to the hospital for bloodwork and a nuclear medicine injection as part of a work up for kidney ablation that the patient was supposed to have completed, patient was in the process of getting ready to have an ablation on her kidney and had the nuclear scan for her kidneys and then went to get a COVID test. After they got home, patient sat down at the computer and she started to act funny, kind of quiet and not talking which was unusual for her. So at about 1700PM the husband went in to ask her what kind of music she would like and he found her unconscious in the chair. He took her blood pressure and it was 60 over 4; with no heart rate; she was just barely breathing, he could tell by the way her mouth moved. He tried to breath for her, all of the sudden she stopped breathing and her heart stopped beating. He called (phone number provided) and they rushed her to the hospital, and the paramedics verified her heart was not beating and they started to do resuscitation. Then they finally pulled her out of the chair and put her on the floor and she started to breath. When they took her to the ambulance she was still not quite coherent; she didn't know what was happening. She was taken to the hospital emergency room and stayed there for 12 hours and they monitored her with an EKG and only saw one spike for 6 seconds. They discharged her on 30Jan2021 afternoon and she has been totally normal 100 percent since then. Since she had been home she had been doing well and has had no other events. Added patient had never had a heart problem before. Caller stated that he was not sure if this event was related to her receiving the vaccine or not. Now they had to stay in quarantine 10 days until 08Feb2021 since the COVID test given at the hospital on 29Jan2021 night when she went in was positive. Patient was scheduled to received the second shot 18Feb2021. Outcome of events unconscious, no heart rate, pressure was 60 over 4 was recovered on 29Jan2021, events started to act funny and stopped breathing was recovered on 30Jan2021, outcome of other events was unknown. The adverse events resulted in emergency room/department or urgent care, patient was taken to the ER and monitored for 12 hours but no admission. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/29/2021,1.0,UNK,ACEBUTOLOL; DICLOFENAC; OXYCODONE; OXYCONTIN,,Medical History/Concurrent Conditions: Blood pressure abnormal; Kidney ablation (ablation on the kidney cancer 5 years ago); Kidney cancer; Neuropathy; Pain; Urinary tract infection (had a urinary tract infection 19Dec2020 and they saw the cancer came back),,,"['Abnormal behaviour', 'Blood pressure abnormal', 'Blood test', 'COVID-19', 'Cardiac arrest', 'Computerised tomogram', 'Electrocardiogram', 'Loss of consciousness', 'Magnetic resonance imaging', 'Respiratory arrest', 'SARS-CoV-2 antibody test']",1,PFIZER\BIONTECH, 1031493,OR,42.0,M,"appendicitis; This is a spontaneous report from a contactable consumer reported for self. This 42-Year-old male received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation. No Covid prior vaccination. No known allergies. No other vaccine in four weeks. Facility type Vaccine: Hospital. He developed appendicitis after the vaccine on 11Jan2021. First symptoms appeared three days after first dose. Checked into hospital for an appendectomy the following day. Treatment was appendectomy. Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 2 days. Lab data included Nasal Swab on 15Jan2021: Negative. Outcome of the event was recovering. Information on Lot/batch number has been requested.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/08/2021,01/11/2021,3.0,PVT,,,,,,"['Appendicitis', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1031494,IA,,F,"Spouse awoke 20Dec and found spouse dead; This is a spontaneous report from a Pfizer sponsored report Corporate (Pfizer) Social Media Platforms. A non-contactable consumer (patient's husband) reported that a female patient of an unspecified age (Age: 89, Units: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899, Expiry date: unknown), intramuscular on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that spouse awoke and found spouse dead on 20Dec2020. Patient was not transferred to hospital. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Spouse awoke 20Dec and found spouse dead",Yes,12/20/2020,Not Reported,Not Reported,,Not Reported,N,,12/20/2020,,UNK,,,,,,['Death'],1,PFIZER\BIONTECH,OT 1031497,,,U,"patient still got covid; Initial information received on 19-Jan-2021 regarding an unsolicited valid serious case from non-healthcare professional. This case involves patient (unknown demographics) who had covid (covid-19), after receiving INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed covid (covid-19) (serious ) (Unknown latency), following the administration of INFLUENZA VACCINE. Covid-19 was assessed as medically significant. No laboratory data reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome is unknown for the event. Information regarding the batch/lot number should be requested.; Sender's Comments: This case involves patient of unknown age who presented with covid-19, after vaccination with INFLUENZA VACCINE .Time to onset is unknown. Moreover, concomitant medication, family history, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['COVID-19'],UNK,UNKNOWN MANUFACTURER,OT 1031544,IA,90.0,F,Patient family had been noticing onset confusion for a few weeks prior to vaccine and event. Patient was taken to ED when found unconscious and died of a subdural hemorrhage a few days after vaccine clinic at retirement home.,Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/14/2021,3.0,SEN,Alendronate 70mg tab Clopidogrel 75mg tab Donepezil 5mg tab Hydrochlorothiazide 12.5mg Lactobacillius tabs Levothyroxine 75mcg tab Lostartan 50mg tab Citrucel PO Metoprolol tartrate 25mg tab Pantoprazole 40mg tab Rosuvastsatin 10mg tab Tria,Diagnosed with subdural hemorrhage at time of incident,Hyperlipideia Hx stroke Hypothyroidism Gastric ulcer HTN Stress incontinence Uterine cancer Late onset Alzheimer's Osteopenia Osteoarthritis Varicose veins in legs Venous insufficiency Adjustment disorder with anxiety,,Ibandronic acid- nausea and vomiting Sulfa- nausea and vomiting Risedronate Environmental- pollen Nitrofurantoin macro Ezetimibe-Simvastatin Codeine- anxiety Erythromycin- nausea,"['Confusional state', 'Death', 'Imaging procedure', 'Loss of consciousness', 'Subdural haemorrhage']",1,MODERNA,IM 1031560,WI,71.0,F,"Morning-back of R side throat discomfort, R eye tearing, 24 hrs later- numbness of R side tongue, R side of lips and cheek lose of muscular control, R eyelid remains open. Evaluated in ER 48 hrs after start of symptoms. DX-Bells Palsy treated with Prednisone & anti-viral. Symptoms continue.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/04/2021,02/12/2021,8.0,OTH,"vitamin c, vitamin d, tumeric, thyroid supplement",,,,,"['Blood electrolytes', 'Computerised tomogram', 'Eyelid disorder', 'Facial paralysis', 'Facial paresis', 'Full blood count', 'Hypoaesthesia oral', 'Lacrimation increased', 'Oropharyngeal discomfort']",1,MODERNA,IM 1031582,WI,35.0,F,"35 yo woman with new onset pericarditis. Possibly related to the covid vaccine - had second dose 1/13/21. There are case reports of pericarditis with the covid virus, but none so far with covid vaccine. No known covid exposure recently. Covid test on 1/24/21 (date of admission) = not detected. Or more likely presentation could be related to Humira (started December 2020 for psoriatic arthritis and had 3 doses total). There have been case reports of pericarditis with Humira. Also, pt was on a medrol dose pack for radicular symptoms after injuring her neck, she finished the dose pack on 1/17/21. Since stopping solumedrol she has had increasing hip pain and also has costochondral pain. Per H&P, It is possible that weaning off of solumedrol dose pack caused a flare up in her psoriatic arthritis leading to increase hip pain, costochondritis and pleuritis and/or pericarditis. Pt was admitted for further treatment and monitoring.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/13/2021,01/25/2021,12.0,PVT,Humira albuterol diclofenac gel fluticasone inhaler (flovent) Probiotic Multivitamin Sumatriptan Medrol dose pak (finished on 1/17/21) Weaned off Lexapro ~ 1 month prior,Psoriatic Arthritis and Cervical DJD,Psoriatic Arthritis and Cervical DJD,,hydromorphone - hives,['Pericarditis'],UNK,PFIZER\BIONTECH, 1031593,GA,81.0,M,"On February 11, 2021 around 10:15 am, patient was given the Moderna brand COVID-19 vaccination. After his vaccination, he was instructed to wait around for 15 minutes after the administration of the vaccine. During this time, there were no reported issues with the patient. On February 15, 2021 around 9:15am, patient's wife called the pharmacy and spoke with the pharmacist informing her that patient had passed away in his sleep on Saturday evening. Patient's wife inquired about whether death may have been caused by an adverse reaction to the vaccine. During the call patient's wife mentioned that patient slept a lot the day of the vaccine and the day after. patient's wife mentioned that patient woke up Saturday to eat breakfast and lunch. She states that later that evening, she found patient asleep and cold which she then realized that he'd passed away.",Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/13/2021,2.0,PHM,"Calcitriol 0.25mcg, glyburide 2.5mg, atorvastatin 40mg, nitroglycerin 0.4mg, furosemide 40mg, isosorbide ER 60mg, warfarin 5mg, gabapentin 300mg, allopurinol 100mg",,,,,"['Death', 'Hypersomnia']",1,MODERNA,IM 1031595,KY,84.0,M,"Unresponsive, Increase BP and H. Hospital Dx Renal Failure",Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,02/05/2021,38.0,SEN,"Lasix, Digoxin, Eliquis, Metoprolol, Celexa, Plavix, Namenda",Covid + 1/6/2021,"CHF, Heart Disease, Dementia, A Flutter HTN",,NKDA,"['Blood pressure increased', 'COVID-19', 'Heart rate increased', 'Renal failure', 'SARS-CoV-2 test positive', 'Unresponsive to stimuli']",UNK,PFIZER\BIONTECH,IM 1031625,NJ,42.0,F,"developed diffuse tender adenopathy, weakness and fevers. Admitted with severe neutropenia - ANC 0.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/06/2021,02/10/2021,4.0,PVT,methimazole atenolol,Grave's disease,Grave's disease,,bacitracin Bactrim sulfa,"['Asthenia', 'Haemoglobin decreased', 'Lymphadenopathy', 'Neutropenia', 'Neutrophil count decreased', 'Pyrexia', 'Tenderness']",1,PFIZER\BIONTECH,SC 1031629,IA,85.0,F,"Patient became nauseated about 10 minutes after vaccine administered, this subsided but returned several hours after the vaccine was given. She continued with intractable nausea and vomiting for about 24 hours. This patient was enrolled in hospice and she continued to decline and refused to eat or drink. She was taking Ibuprofen due to intractable back pain. Her emesis was coffee ground color. After this her condition continued to decline until her death",Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/08/2021,0.0,PVT,"Amlodipine, Fentanyl Transdermal, Gabapentin, Lorazepam, Metoprolol, Morphine, Omeprazole, ONdansetron, Miralax, Tylenol, Ibuprofen",Compression fracture,"Abdominal Aortic Aneurysm, Constipation, Malnutrition, Peripheral Vascular Disease",,"GI upset from Fentanyl, No other food or drug allergies","['Back pain', 'Death', 'Diet refusal', 'Fluid intake reduced', 'General physical health deterioration', 'Haematemesis', 'Nausea', 'Vomiting']",7+,MODERNA,IM 1031636,NE,60.0,M,Patient developed SVT on January 31. He presented to the ER and received two doses of adenosine to convert back to a normal sinus rhythm.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/26/2021,01/31/2021,5.0,PVT,None,None,History of SVT,,Strawberries,"['Condition aggravated', 'Electrocardiogram', 'Supraventricular tachycardia']",1,MODERNA,IM 1031691,NE,89.0,M,Pt brought to ER by son on 2/7/21 after noting increased confusion. Patient states he is going to visitor or do things that have not been around for years. Son reports onset was 24 hour prior. Pt does have some cognitive decline historically but current behaviors are a sudden change. Patient admitted observation to hospital and then discharged to local nursing home.,Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/05/2021,02/07/2021,2.0,PVT,No known medication,No known illnesses,"CKD, Prostate CA, Type 2 DM",,"Penicillin, sulfa","['Condition aggravated', 'Confusional state', 'Haematology test normal', 'Laboratory test normal', 'SARS-CoV-2 test negative', 'Urine analysis normal']",1,MODERNA,IM 1031725,KY,89.0,M,2/14/2021 Resp panel: COVID19 + Started on 2/14/21 Dexamethasone 6 mg po daily and on 2/15/21 Remdesivir 200 mg IV x1 dose then 100 mg IV daily x 4 doses. 89-year-old male presents to the emergency room with epigastric abdominal pain and shortness of breath and was found to have acute pancreatitis and COVID-19 pneumonia.,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/08/2021,02/12/2021,4.0,PVT,"Proscar, Gabapentin, Glimepiride, Azithromycin, Acetaminophen, Pravastatin, Silodosin, Cyanocobalamin, Triamcinolone 0.1% cream",? Back pain � ? Diabetes mellitus ? Hyperlipidemia � ? Immobility � ? Low back pain � ? Neuropathy � ? Neuropathy � ? Prostate enlargement � �,See Item 11,,Aspirin,"['Abdominal pain', 'Abdominal pain upper', 'Blood creatine phosphokinase', 'Blood lactate dehydrogenase', 'C-reactive protein', 'COVID-19', 'COVID-19 pneumonia', 'Chest X-ray', 'Dyspnoea', 'Metabolic function test', 'Pancreatitis acute', 'Procalcitonin', 'Respiratory viral panel', 'Serum ferritin', 'Troponin']",1,PFIZER\BIONTECH,IM 1031767,MN,93.0,F,"1/31/2021 12:50 Nursing Note Note Text: Res had low BP, low O2 sats, 30 breaths per minute, eyes open wide, making confused utterances. Started supplemental oxygen via NC, 2L, then 3L. Sats went up to 93% for a while, Sprvsr called. Unable to auscultate Left lung sounds. Called to update Res daughter. Called to page NP, writer went back to assess Res and O2 sats were 88%, turned O2 to 4LPM, called 911 for transport to Hospital ED. Left around 1030. NP called back afterwards, was updated. Family updated that Res was sent to Hospital ED. Note Text: Received phone call from daughter as well as information from hospital. Resident has pneumonia with septic shock. She is on abx and had thoracentesis performed for large pleural effusion. [linked]",Yes,02/04/2021,Not Reported,Yes,5.0,Not Reported,N,01/30/2021,01/31/2021,1.0,SEN,Polyethylene Glycol 3350 Powder Calcium-Vitamin D Tablet 500-200 MG-UNIT (Calcium Carb-Cholecalciferol) Lidocaine Patch 4 % Tylenol Extra Strength Tablet 500 MG (Acetaminophen) Melatonin Tablet 3 MG traMADol HCl Tablet 50 MG Ferrous Glucona,"ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS ESSENTIAL (PRIMARY) HYPERTENSION POLYNEUROPATHY, UNSPECIFIED GENERALIZED ANXIETY DISORDER LOCALIZED EDEMA GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS INSOMNIA, UNSPECIFIED UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE DYSPHAGIA, UNSPECIFIED DIFFICULTY IN WALKING, NOT ELSEWHERE CLASSIFIED WEAKNESS MAJOR DEPRESSIVE DISORDER, SINGLE EPISODE, UNSPECIFIED ACUTE POSTHEMORRHAGIC ANEMIA DISPLACED INTERTROCHANTERIC FRACTURE OF LEFT FEMUR, SUBSEQUENT ENCOUNTER FOR CLOSED FRACTURE WITH ROUTINE HEALING HYPERLIPIDEMIA, UNSPECIFIED AGE-RELATED OSTEOPOROSIS WITHOUT CURRENT PATHOLOGICAL FRACTURE OLD MYOCARDIAL INFARCTION HISTORY OF FALLING PERSONAL HISTORY OF PEPTIC ULCER DISEASE BARIATRIC SURGERY STATUS PRESENCE OF LEFT ARTIFICIAL KNEE JOINT PRESENCE OF RIGHT ARTIFICIAL SHOULDER JOINT PRESENCE OF LEFT ARTIFICIAL SHOULDER JOINT","ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS ESSENTIAL (PRIMARY) HYPERTENSION POLYNEUROPATHY, UNSPECIFIED GENERALIZED ANXIETY DISORDER LOCALIZED EDEMA GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS INSOMNIA, UNSPECIFIED UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE DYSPHAGIA, UNSPECIFIED DIFFICULTY IN WALKING, NOT ELSEWHERE CLASSIFIED WEAKNESS MAJOR DEPRESSIVE DISORDER, SINGLE EPISODE, UNSPECIFIED ACUTE POSTHEMORRHAGIC ANEMIA DISPLACED INTERTROCHANTERIC FRACTURE OF LEFT FEMUR, SUBSEQUENT ENCOUNTER FOR CLOSED FRACTURE WITH ROUTINE HEALING HYPERLIPIDEMIA, UNSPECIFIED AGE-RELATED OSTEOPOROSIS WITHOUT CURRENT PATHOLOGICAL FRACTURE OLD MYOCARDIAL INFARCTION HISTORY OF FALLING PERSONAL HISTORY OF PEPTIC ULCER DISEASE BARIATRIC SURGERY STATUS PRESENCE OF LEFT ARTIFICIAL KNEE JOINT PRESENCE OF RIGHT ARTIFICIAL SHOULDER JOINT PRESENCE OF LEFT ARTIFICIAL SHOULDER JOINT",,Dilaudid,"['Aspiration pleural cavity', 'Confusional state', 'Death', 'Hypotension', 'Oxygen saturation decreased', 'Pleural effusion', 'Pneumonia', 'Septic shock', 'Staring']",2,MODERNA,IM 1031775,IL,65.0,M,Right facial palsy (Bells Palsy),Not Reported,,Not Reported,Yes,4.0,Yes,N,01/18/2021,02/08/2021,21.0,PVT,Mesalamine Gabapentin Insulin Diamox Lipitor Plavix,None,Diabetes Ulcerative colitis,,None,['Facial paralysis'],1,MODERNA,IM 1031780,NY,91.0,M,"Patient was not seen at our facilities prior to or after COVID-19 vaccination. Patient received first dose on 1/23/2021 and as reported by the family member, patient expired on 2/5/21. Symptoms were reported to have stared on 2/1/2021, 9 days after receiving the first dose with a drop in oxygen levels and fever. He was reported to also have a history of chronic lung disease. Patient's family member to be contacted if necessary.",Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,01/23/2021,02/01/2021,9.0,PVT,Unknown,Unknown,Reported chronic lung disease. Additional details are unknown.,,Unknown,"['Death', 'Oxygen saturation decreased', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1031786,MN,88.0,M,"presented to ED with stroke like symptoms, slurred speech, weakness, hypotension and tachycardia. Stroke team activated and no hemorrhage noted on CT. Treated with alteplase after consult with neurology and then transferred to hospital for further evaluation and treatment.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/29/2021,02/07/2021,9.0,PVT,"allopurinol, aspirin, celery seed extract, centrum, colchicine, crestor, furosemide, glucosamine, Indocin, lisinopril, potassium",none,"HTN, CAD, previous stroke, previous MI, CKD, gout, HLD, neuropathy, BPH, basal cell carcinoma, diverticulosis, tubular adenoma of colon",,"Darvocet, Demerol, adhesive, dasatinib","['Activated partial thromboplastin time', 'Asthenia', 'Blood gases', 'Computerised tomogram normal', 'Dysarthria', 'Full blood count', 'Hypotension', 'International normalised ratio', 'Metabolic function test', 'Neurological symptom', 'SARS-CoV-2 test', 'Tachycardia', 'Troponin']",1,PFIZER\BIONTECH, 1031790,WI,94.0,F,"Received influenza vaccine 1/29 at PCP clinic. Received Moderna vaccine on 2/6 by pharmacist at her place of residence. She was taken to the ER on 2/9, unresponsive. Staff reported she wasn't acting normally since 2/7. During her hospital course (2/9-2/13) she was only able to open her eyes. Unable to follow any commands. MRI showed large right MCA stroke. She was discharged from the hospital on hospice.",Not Reported,,Yes,Yes,4.0,Yes,N,02/06/2021,02/07/2021,1.0,SEN,Docusate Vitamin D,None,Dementia Chronic pain Arthritis Anxiety Vit D deficiency,,Tramadol,"['Cerebrovascular accident', 'Magnetic resonance imaging brain abnormal', 'Unresponsive to stimuli']",1,MODERNA,IM 1031808,,72.0,F,"patient vaccinated on 2/12, woke up dizzy on 2/13, taken by ambulance to hospital and remained overnight. treated with IV fluids, meclizine and Ativan. patient was on day 10 of antibiotics for ear infection",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/12/2021,02/13/2021,1.0,UNK,,,,,,['Dizziness'],UNK,MODERNA, 1031821,MN,81.0,M,Presented to ED with altered mental status. He became fatigued and lethargic with a brief period of unresponsiveness. Could not speak and had a gaze to his left. Could not carry on conversation or answer questions appropriately. Stroke team activated and CT completed. CT negative for bleed. Neurology ordered Alteplase to be administered. Patient then transferred for further evaluation and treatment. Patient had left MCA occlusion with TICI IIb achieved. Admitted to neurology stroke service in ICU following procedure. Started on aspirin with plavix. Rehab referral.,Not Reported,,Not Reported,Yes,,Not Reported,,01/28/2021,02/07/2021,10.0,PVT,"amlodipine, aspirin, calcium, coreg, losartan, Lupron, multivitamin, omeprazole, pravastatin, prolia",unknown,"CAD, HLD, GERD, HTN, prostate cancer, hernia, thrombocytopenia,",,lisinopril,"['Activated partial thromboplastin time', 'Aphasia', 'Blood creatine phosphokinase', 'Blood creatine phosphokinase MB', 'Cerebral artery occlusion', 'Cerebrovascular accident', 'Computerised tomogram head', 'Fatigue', 'Full blood count', 'Intensive care', 'International normalised ratio', 'Lethargy', 'Mental status changes', 'Metabolic function test', 'Prothrombin time', 'Troponin', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 1031823,TN,34.0,F,"The patient, who is my wife, went into preterm labor and delivered at 30 weeks and 3 days. Date of delivery was 2/9/21. EDD was 4/17/21. My wife is a G3P2. She had a very early miscarriage in 2016. She delivered a healthy child at 37 weeks and 3 days in 2018. During this current pregnancy, all prenatal visits, tests, and scans were unremarkable. Based on a gross examination of the placenta and a review of all clinical data by the patient's OBGYN, there was no obvious stimulus for the preterm labor. Fortunately, the baby is doing ok in the NICU at hospital.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/06/2021,02/09/2021,3.0,PUB,"Prenatal vitamin, omega 3 supplement, Zyrtec",Mild viral URI symptoms several weeks prior. Multiple people in family tested negative for COVID at that time.,Chronic urticaria,,No,"['Exposure during pregnancy', 'Fibronectin normal', 'Premature labour']",2,PFIZER\BIONTECH,IM 1031828,CA,93.0,F,"Severe, acute onset of vertigo and bradycardia",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/31/2021,02/14/2021,14.0,PVT,"Metroprolol, Lasic, Eliquis, K-Tab. Vit C, Vit D, CoQ10, Magnesium, Calcium, Melatonin",None,"History of stroke, prediabetic",,Codiene,"['Blood electrolytes', 'Blood test', 'Bradycardia', 'Computerised tomogram', 'Electrocardiogram', 'Lipids', 'Magnetic resonance imaging', 'Vertigo']",1,MODERNA,SYR 1031836,MN,66.0,M,New occurrence of gross hematuria 2 days after vaccination. Required hospitalization. Found to be related to papillary tumor of bladder via cystoscopy procedure.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/11/2021,02/13/2021,2.0,PVT,"Aspirin 325 mg, Gabapentin, Glipizide, Metformin, Pioglitazone, Lisinopril, Simvastatin, Omeprazole, Polycarbophil calcium",None,"Hypertension, peripheral arterial disease, coronary artery disease, type 2 diabetes mellitus",,"Cilostazol, Penicillins","['Bladder transitional cell carcinoma', 'Cystoscopy abnormal', 'Haematuria']",1,MODERNA, 1031846,WA,,F,"Patient and her husband are elderly, but healthy and live independently. Patient took blood pressure medicine 'off and on' according to family. She was 5'2"", 120 pounds and slim and healthy and active, so was her husband, though he had pulmonary fibrosis so they had been staying home and not attending church etc, and masking when they did go out to protect against covid disease. They were both vaccinated with covid Pfizer vaccine (dose #1) on Thursday Feb 11. (02/11/2021) Thursday night as they went to bed they checked in with each other on how they each felt. Patient said she felt totally fine, and her husband said his arm was a bit sore. Patient woke before her husband on Friday Feb 12, went downstairs and, from what the family can tell, fixed herself a snack, then sat on the sofa. Patient's husband found her deceased on the sofa. He called 911 and they asked him to do CPR until the paramedics arrived. Because of proximity to covid vaccine, the ME wanted to examine the body in the home and also ordered an autopsy. Autopsy was completed on the same day as death, Feb 12, 2021",Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/12/2021,1.0,UNK,"HTN meds taken 'off and on', UNK other medications etc.",UNK,"HTN, other unk",,UNK,"['Autopsy', 'Cerebral haemorrhage', 'Condition aggravated', 'Coronary artery occlusion', 'Death', 'Hypertension', 'Resuscitation']",UNK,PFIZER\BIONTECH, 1031879,MN,87.0,M,"1/31/2021 03:56 Nursing Note Note Text: Pt. c/o R Abd pain at the waist line. Pt. stated it felt like a muscle being pulled. Not constipated, bowel sounds active. Took VS and they are charted. Writer called on call and spoke to NP and she stated to give him Tylenol and check the above. Bowel sounds and such. So writer did give him Tylenol at 3:45am. 1/31/2021 12:53 Admit/Discharge/Transfer Note Note Text: at 1030 pt stated that he had been having RLQ pain for the past hour. VS retaken. Described pain as constant but ""increases suddenly"" to an 8 on a 10 point pain scale. worsens with movement, alleviates with rest. RLQ pain radiates to R shoulder and around to his R lower back. bowel sounds x4, tender abd in right lower quadrant and upper right quadrant. follow-up assessment at 1220 found rebound pain. pt states last bm was yesterday and it was brown, formed, easy to pass. Lower posterior R lung sounds diminished and lower posterior L lung fields contain crackles. at 742: temp 98F, 140/68, 02 saturation 96%, respiration 16. denies n&v. ate pancakes, sausage, and fruit for breakfast. gave morning pantoprazole, held morning am medications. Called on call triage nurse and NP. on call NP suggested sending pt to hospital. transferred to hospital via ambulance and paramedics at 1240.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/29/2021,01/31/2021,2.0,SEN,Sennosides Tablet 8.6 MG Nitroglycerin Tablet Sublingual 0.4 MG Tylenol Extra Strength Tablet 500 MG (Acetaminophen) predniSONE Tablet 5 MG predniSONE Tablet 1 MG Pantoprazole Sodium Tablet Delayed Release 20 MG Metoprolol Tartrate Tablet 5,"OTHER PULMONARY EMBOLISM WITHOUT ACUTE COR PULMONALE POLYMYOSITIS, ORGAN INVOLVEMENT UNSPECIFIED ACUTE RESPIRATORY FAILURE WITH HYPOXIA PARALYTIC SYNDROME, UNSPECIFIED ACUTE KIDNEY FAILURE, UNSPECIFIED ANEMIA, UNSPECIFIED DYSPHAGIA, OROPHARYNGEAL PHASE VENOUS INSUFFICIENCY (CHRONIC) (PERIPHERAL) THROMBOCYTOPENIA, UNSPECIFIED ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITH UNSPECIFIED ANGINA PECTORIS LOBAR PNEUMONIA, UNSPECIFIED ORGANISM RIGHT LOWER QUADRANT PAIN SEPSIS, UNSPECIFIED ORGANISM CONTUSION OF UNSPECIFIED THIGH, SUBSEQUENT ENCOUNTER ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS ESSENTIAL (PRIMARY) HYPERTENSION PRESENCE OF OTHER VASCULAR IMPLANTS AND GRAFTS PURE HYPERCHOLESTEROLEMIA, UNSPECIFIED HISTORY OF FALLING OLD MYOCARDIAL INFARCTION LOCALIZED EDEMA NONTOXIC SINGLE THYROID NODULE SOLITARY PULMONARY NODULE","OTHER PULMONARY EMBOLISM WITHOUT ACUTE COR PULMONALE POLYMYOSITIS, ORGAN INVOLVEMENT UNSPECIFIED ACUTE RESPIRATORY FAILURE WITH HYPOXIA PARALYTIC SYNDROME, UNSPECIFIED ACUTE KIDNEY FAILURE, UNSPECIFIED ANEMIA, UNSPECIFIED DYSPHAGIA, OROPHARYNGEAL PHASE VENOUS INSUFFICIENCY (CHRONIC) (PERIPHERAL) THROMBOCYTOPENIA, UNSPECIFIED ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITH UNSPECIFIED ANGINA PECTORIS LOBAR PNEUMONIA, UNSPECIFIED ORGANISM RIGHT LOWER QUADRANT PAIN SEPSIS, UNSPECIFIED ORGANISM CONTUSION OF UNSPECIFIED THIGH, SUBSEQUENT ENCOUNTER ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS ESSENTIAL (PRIMARY) HYPERTENSION PRESENCE OF OTHER VASCULAR IMPLANTS AND GRAFTS PURE HYPERCHOLESTEROLEMIA, UNSPECIFIED HISTORY OF FALLING OLD MYOCARDIAL INFARCTION LOCALIZED EDEMA NONTOXIC SINGLE THYROID NODULE SOLITARY PULMONARY NODULE",,"Amlodipine, Statins","['Abdominal pain', 'Abdominal pain lower', 'Abdominal rebound tenderness', 'Abdominal tenderness', 'Arthralgia', 'Back pain', 'Blood test', 'Breath sounds abnormal', 'Chest X-ray', 'Computerised tomogram abdomen', 'Computerised tomogram thorax', 'Pain', 'Rales']",2,MODERNA,IM 1031884,HI,82.0,F,"7 days post COVID #1 vaccine, onset of bilateral leg claudication (1/31/21). Subsequently dx'd with acute bilateral arterial clots in both legs requiring thrombolysis, bilateral popliteral/artery thromboembolectomy, heparin. Acute clot per vascular surgeon. Surgery performed 2/12/21.",Not Reported,,Not Reported,Yes,4.0,Yes,N,01/25/2021,01/31/2021,6.0,PVT,"Lisinopiril, atorvastatin, advair, metoprolol, amlodipine",,"Cognitive impairment, Afib, HTN, atherosclerosis of aorta, bronchiectasis, CKD4, gastric ulcer, hx of intracerebral hemorrhage, hx of stroke, hyperlipidemia",,aspirin,"['Intermittent claudication', 'Peripheral embolism', 'Thromboembolectomy', 'Thrombolysis']",1,PFIZER\BIONTECH,IM 1031899,CA,32.0,M,Severe hives and swelling in face/lips appx 3.5 days after getting 1st dose of Covid-19 Moderna Vaccine. Blood test showed that I am suddenly highly allergic to 19 different food groups. I have no known food allergies prior to C19 Moderna Vaccine. I have had hives every single day since they 1st appeared (3.5 days after vaccine). I have had multiple days of facial swelling as well and have been to the hospital multiple times. To this date (date of this report) I still have hives and facial swelling. Facial swelling is intermittent. I have stayed away from the list of foods that I am apparently suddenly allergic to and I still have hives and swelling. I occasionally have a irritated throat which makes it difficult to breathe in. I have a specialist appointment with an allergy/immunology doctor this coming Thursday to see what thier diagnosis is. My family doctor believes my potential angioedema diagnosis is directly related to my 1st dose of C19 Moderna Vaccine.,Not Reported,,Yes,Not Reported,,Not Reported,N,01/16/2021,01/19/2021,3.0,PVT,None.,None.,Kidney stones. High triglycerides.,,Only known allergy is Penicillin.,"['Angioedema', 'Blood test abnormal', 'Dyspnoea', 'Food allergy', 'Lip swelling', 'Swelling face', 'Throat irritation', 'Urticaria']",1,MODERNA,SYR 1031901,MN,77.0,M,"1/30/2021 23:08 Nursing Note Note Text: Patient refused to use incentive spirometer at bedtime. Writer administered prn Mucinex at 1600 and 2130 for upper chest congestion. 02 at 1 liter per NC during thru the night for comfort. 02 sats at 95%. Writer encouraged fluids at bedside. Patient was compliant in taking a shower earlier this afternoon but refused supper. Patient has been mildly confused to place and time, reoriented easily. Will continue monitor vital signs and encourage incentive spirometer. 1/31/2021 00:15 Nursing Note Note Text: Patient had very large incontinent fowl smelling bloody stools at mid noc. Writer called Nurse supervisor also to assess stool. MD was called new order to send patient to hospital for evaluation. Wife was called and updated, bedhold obtained.",Not Reported,,Not Reported,Yes,7.0,Not Reported,Y,01/29/2021,01/30/2021,1.0,SEN,Pantoprazole Sodium Tablet Delayed Release 40 MG Multivitamin Tablet (Multiple Vitamin) guaiFENesin ER Tablet Extended Release 12 Hour 600 MG Atorvastatin Calcium Tablet 40 MG Aspirin EC Tablet Delayed Release 81 MG (Aspirin) Apixaban,"ENCOUNTER FOR SURGICAL AFTERCARE FOLLOWING SURGERY ON THE CIRCULATORY SYSTEM PRESENCE OF OTHER VASCULAR IMPLANTS AND GRAFTS PRESENCE OF PROSTHETIC HEART VALVE OTHER SPECIFIED DISORDERS OF ARTERIES AND ARTERIOLES NONRHEUMATIC AORTIC (VALVE) STENOSIS CEREBRAL INFARCTION DUE TO UNSPECIFIED OCCLUSION OR STENOSIS OF LEFT MIDDLE CEREBRAL ARTERY APHASIA FOLLOWING CEREBRAL INFARCTION ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS THORACIC AORTIC ANEURYSM, WITHOUT RUPTURE UNSPECIFIED ATRIAL FIBRILLATION GASTROINTESTINAL HEMORRHAGE, UNSPECIFIED ACUTE DUODENAL ULCER WITHOUT HEMORRHAGE OR PERFORATION POLYP OF COLON ABNORMAL ELECTROCARDIOGRAM [ECG] [EKG] LONG TERM (CURRENT) USE OF ANTICOAGULANTS ESSENTIAL (PRIMARY) HYPERTENSION HYPERLIPIDEMIA, UNSPECIFIED RETENTION OF URINE, UNSPECIFIED ACUTE POSTHEMORRHAGIC ANEMIA ALCOHOL ABUSE, UNCOMPLICATED DIAPHRAGMATIC HERNIA WITHOUT OBSTRUCTION OR GANGRENE OTHER POSTPROCEDURAL COMPLICATIONS AND DISORDERS OF THE CIRCULATORY SYSTEM, NOT ELSEWHERE CLASSIFIED","ENCOUNTER FOR SURGICAL AFTERCARE FOLLOWING SURGERY ON THE CIRCULATORY SYSTEM PRESENCE OF OTHER VASCULAR IMPLANTS AND GRAFTS PRESENCE OF PROSTHETIC HEART VALVE OTHER SPECIFIED DISORDERS OF ARTERIES AND ARTERIOLES NONRHEUMATIC AORTIC (VALVE) STENOSIS CEREBRAL INFARCTION DUE TO UNSPECIFIED OCCLUSION OR STENOSIS OF LEFT MIDDLE CEREBRAL ARTERY APHASIA FOLLOWING CEREBRAL INFARCTION ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS THORACIC AORTIC ANEURYSM, WITHOUT RUPTURE UNSPECIFIED ATRIAL FIBRILLATION GASTROINTESTINAL HEMORRHAGE, UNSPECIFIED ACUTE DUODENAL ULCER WITHOUT HEMORRHAGE OR PERFORATION POLYP OF COLON ABNORMAL ELECTROCARDIOGRAM [ECG] [EKG] LONG TERM (CURRENT) USE OF ANTICOAGULANTS ESSENTIAL (PRIMARY) HYPERTENSION HYPERLIPIDEMIA, UNSPECIFIED RETENTION OF URINE, UNSPECIFIED ACUTE POSTHEMORRHAGIC ANEMIA ALCOHOL ABUSE, UNCOMPLICATED DIAPHRAGMATIC HERNIA WITHOUT OBSTRUCTION OR GANGRENE OTHER POSTPROCEDURAL COMPLICATIONS AND DISORDERS OF THE CIRCULATORY SYSTEM, NOT ELSEWHERE CLASSIFIED",,No Known Allergies,"['Abnormal faeces', 'Blood test', 'Colonoscopy', 'Confusional state', 'Diet refusal', 'Haematochezia', 'Oesophagogastroduodenoscopy', 'Refusal of treatment by relative', 'Transfusion', 'Upper respiratory tract congestion']",2,MODERNA,IM 1031909,FL,56.0,F,"Pt received dose #1 of COVID-19 vaccine (Pfizer-BioNTech) on 12/18/20 and dose #2 ( Pfizer-BioNTech) on 1/8/21. On 1/30, patient was evaluated at urgent care due to back pain. No bloodwork done; metronidazole prescribed for 7 days. On 2/8, patient was admitted to outside hospital due to ongoing symptom progression. At time of admission, hgb 5 g/dL and plt 9k. Per Dr. (hematology/oncology), pt with schistocytes, LDH 1500, and elevated reticulocyte count consistent with thrombotic thrombocytopenic purpura (TTP). SCr >2 mg/dL. Patient immediately treated with plasma exchange and steroids, however continued to decline. Patient expired on 2/14/21.",Yes,02/14/2021,Not Reported,Yes,6.0,Not Reported,N,01/08/2021,01/30/2021,22.0,PVT,"Acetaminophen 650 mg PO q4h PRN for pain, amlodipine 10 mg PO daily, atenolol 100 mg PO daily, calcium carbonate/cholecalciferol 600 mg/200 mg PO BID, fluticasone 50 mcg per nare daily, HCTZ 25 mg PO daily, phentermine 37.5 mg PO AC breakfa",None known,"Allergic rhinitis, insomnia, anxiety state, Sjogren's disease, joint pain, GERD without esophagitis, hypertension, vulvar cysts, recurrent maxillary sinusitis, herpres",,"amoxicillin (swelling), sulfur (swelling), loratadine (rash)","['Back pain', 'Blood creatinine increased', 'Blood lactate dehydrogenase increased', 'Death', 'Haemoglobin decreased', 'Platelet count decreased', 'Red blood cell schistocytes', 'Reticulocyte count increased', 'Thrombotic thrombocytopenic purpura']",2,PFIZER\BIONTECH,IM 1031925,OH,71.0,M,"On 2/9/2021 experienced headache, chills, and sore arm 0n 2/10/2021 still experiencing similar side effects but know light headed On 2/11/2-12: 930AM experienced a TIA . I totally believed it was a by product of the Covid shot - 1st dose. Had to go to ER and go through series of tests. Now on blood thinner. Since this occurred i know of 2 people that had similar results and experienced a stroke with 2 of them experiencing major stroke and died. people had similar results Now I don't think I will take second dose - very scared NOTE: I was in great shape prior to this vaccine",Not Reported,,Yes,Not Reported,,Not Reported,N,02/09/2021,02/11/2021,2.0,OTH,metformin simvastatin vitamin D3,none good health,diabetes,,none,"['Angiogram', 'Chills', 'Electrocardiogram', 'Headache', 'Magnetic resonance imaging', 'Pain in extremity', 'Transient ischaemic attack']",UNK,MODERNA,SYR 1031942,PA,91.0,F,Significant loss of vision R eye-awoke on Feb 6 and noted splotches in vision of R eye. Workup suggests compromised blood flow to that eye,Not Reported,,Not Reported,Yes,1.0,Yes,N,02/03/2021,02/06/2021,3.0,OTH,"Amiodorone 200 mg, Oxcarbezapine400 mg, Aspirin 81mg, Vitamin D 1000Units, Levothyroxine 25 mcg",Non,"Osteoporosis, Atrial fibrillation(controlled), Cavernous sinus meningioma, spinal stenosis,",severe arm swelling after Flu shot about 25 yrs ago,"Canola Oil,Flu shot(severe arm swelling) ( difficulty breathing) Advil and Aleve (hives)","['Angiogram', 'Angiogram retina', 'Blindness unilateral', 'Magnetic resonance imaging brain', 'Optical coherence tomography', 'Retinal ischaemia', 'Ultrasound Doppler', 'Ultrasound eye', 'Visual impairment']",1,PFIZER\BIONTECH,IM 1031977,ME,88.0,F,"Patient started having fever 2 days after second dose of Pfizer mrna vaccine. First dose occurred January 19, 2021 and was uncomplicated. Fevers continued and she started to have delirium and increased neurologic symptoms that mimicked stroke 6 days after vaccination. She was admitted 6 days after vaccination with fever 102, delirium.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/05/2021,02/07/2021,2.0,PVT,"apixaban, hydrochlorothiazide, atorvastatin, Lisinopril, metoprolol, escitalopram, vitamin D, calcium",,"stroke with left sided deficits, atrial fibrillation",,NKDA,"['Blood culture negative', 'Computerised tomogram abdomen', 'Computerised tomogram normal', 'Computerised tomogram thorax normal', 'Delirium', 'Herpes simplex test negative', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Mental status changes', 'Neurological symptom', 'Pyrexia', 'SARS-CoV-2 test negative', 'Urine analysis normal', 'Varicella virus test negative', 'White blood cell count increased']",1,PFIZER\BIONTECH, 1031993,MN,89.0,M,Patient reported mild flu like symptoms from vaccination later that evening. Next morning LTCF staff found pt deceased,Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,PHM,Unkown,,,,KNDA or other allergies listed,"['Death', 'Influenza like illness']",2,MODERNA,IM 1032054,CA,88.0,M,Loss of hearing in right ear. Treated with oral prednizone protocol. No notieable improvement.,Not Reported,,Not Reported,Not Reported,,Yes,N,01/20/2021,01/24/2021,4.0,OTH,,,,,,"['Acoustic stimulation tests abnormal', 'Deafness', 'Magnetic resonance imaging']",UNK,MODERNA,ID 1032062,ME,26.0,M,"After receiving the Moderna vaccine on 2/10/2021, traditionally expected symptoms developed on 2/11/2021 and 2/12/2021 including fatigue, fever, headache, and general achiness. On 2/12/2021 and into the morning of 2/13/2021 I developed a persistent aching chest pain - Saturday morning (2/13/2021) I went to convenient urgent care in for a quick once-over including vitals and an EKG. The EKG showed ST elevations, and I was taken via ambulance to the hospital emergency room. With blood lab value analysis and an echocardiogram performed, the hospitalist and cardiologist determined the diagnosis to be peri myocarditis. I was admitted to the hospital for 24 hours of observation and was released on 2/14/2021.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/10/2021,02/11/2021,1.0,PVT,,,,,None,"['Chest pain', 'Electrocardiogram ST segment elevation', 'Fatigue', 'Headache', 'Myocarditis', 'Pain', 'Pyrexia']",2,MODERNA,IM 1032141,NC,67.0,M,"Patient received 2nd dose on 2/2 at 0733. Patient missed worked on 2/3/21 due to ""effects from COVID vaccine"". Patient was unable to go to work due to disorientation, confusion, headache, and chills. The patient's employee health department advised the patient's family to send patient to be seen by ED. Per ED note patient had complaint of intermittent confusion and disorientation, and fever. Symptoms started after he received his second Covid vaccine. Patient was alert and oriented when seen by ED physician. Patient described symptoms as coming and going, have been worse when he first wakes up. Patient has a past history of seizures and TIA. Provider admitted to make sure he was not having further seizures or TIA. Patient was observed and discharged on feb 5. Per discharging provider the patient had some mild low-grade fever with negative cultures. Provider unsure if fever due to vaccine or mild case of bronchitis-patient discharged on a Zithromax pack.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/02/2021,02/03/2021,1.0,PVT,Aggrenox 200/25 1 cap PO BID Atorvastatin 40 mg po HS Cetirizine 10 mg po daily Clonazepam 1 mg po hs Diclofenac sodium gel 2 GM top QUID Depakote 750 mg po BID Colace 100 mg po hs lansoprazole 30 mg po acb lisinopril 2.5 mg po daily Toprol,unknown,"CVA, Hypertension, CAD, TIA, MI, ""migraine induced stroke like symptoms""",,NKA,"['Blood culture negative', 'Chills', 'Confusional state', 'Culture urine negative', 'Disorientation', 'Headache', 'Impaired work ability', 'Influenza virus test negative', 'Pyrexia', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 1032142,TN,29.0,M,"Within 5 minutes following administration: - Paresthesia and pain in left upper extremity extending from shoulder to hand Within 48 hours following administration: - Progressive pain in left upper extremity - Greatly reduced range of motion in left upper extremity - Inability to bear any weight in left upper extremity - Large ecchymotic lesion at head of left humerus After 48 hours to current presentation: - Pain in the left proximal arm, left shoulder, left upper back, and left neck extending to the occiput - Painful spasticity in the left proximal arm, left shoulder, left upper back, and left neck extending to the occiput - Pain-restricted impaired range of motion of the neck including flexion, extension, lateral rotation, medial rotation, and lateral bending - Pain restricted impaired range of motion of the left upper arm including flexion, extension, lateral rotation, medial rotation, and abduction - Painful left-sided dysphagia at the level of the cricoid cartilage - Use of left arm impaired versus baseline with no signs of improvement",Not Reported,,Not Reported,Not Reported,,Yes,N,01/16/2021,01/16/2021,0.0,SCH,Escitalopram 10 mg once daily Amphetamine 20 mg twice daily,Pityriasis-like rash following first dose of Pfizer COVID-19 vaccine,Depression ADHD,,No known allergies,"['Back pain', 'Dysphagia', 'Ecchymosis', 'Injection site pain', 'Injection site paraesthesia', 'Joint range of motion decreased', 'Neck pain', 'Pain', 'Pain in extremity', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 1032161,NH,86.0,M,"The day after the 2nd shot, patient developed blisters on his lips and mouth. The care facility said that he had a nut allergy -- but he had never been allergic to nuts. He stopped eating and drinking and his BP had dropped to 60/40. By Jan 16th they called to say he was dying and he passed away on 1/18/21. Patient had COVID19 from Oct 29th - early November. By Nov 21st he had lost 40 lbs. He was 6'3"" and had gone from 189lbs to 149 lbs with COVID. By Nov 21st when we could visit, he had recovered from COVID, but was very thin and weak. He could not bathroom alone and kept falling. He didn't seem to have a bad reaction to the 1st COVID shot, But he immediately reacted to the 2nd shot and passed away within 6 days.",Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,SEN,"Vitamin D, Methotrexate","Dementia, Arthritis","Dementia, Arthritis","Shingles - Glaxo 8/22/2020, resulted in hospitalization and LTC.",none,"['Asthenia', 'Blood pressure decreased', 'Death', 'Decreased appetite', 'Fall', 'Food refusal', 'Lip blister', 'Oral mucosal blistering', 'Weight decreased']",2,PFIZER\BIONTECH,IM 1032163,GA,51.0,F,"Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up to ankles, later rising up to her knees. Pt admitted to hospital on 2/6/21 for symptomatic anemia 2/2 vaginal bleeding. Patient received 4 units FFP, 4 units PRBC, 1 unit cryoprecipitate, and vitamin K 5 mg IV. Also started on medroxyprogesterone 20 mg PO TID. Alectinib d/ced due to worsening liver function. Evalauted by OB/GYN and Hematology. Diagnosed with DIC. Patient with worsening bilateral lower extremity edema and purpura with pain and weakness. Palliative care consulted. Patient passed away on 2/11.",Yes,02/11/2021,Not Reported,Yes,5.0,Not Reported,N,01/16/2021,02/01/2021,16.0,PVT,"Albuterol 2.5 mg via nebulizer q4h PRN for SOB, alectinib 600 mg PO BID, apixaban 5 mg BID, bumetanide 2 mg q other day, calcium-vitamin D 500-200 mg BID, famoitidine 20 mg daily, ferrous sulfate 325 mg BID, methadone 5 mg q6h, midodrine 10",Progressive liver metastases seen on CT 1/26/21 in the setting of metastatic non-small cell lung cancer (diagnosed 9/2020),"HPV, iron deficiency anemia, abnormal uterine bleeding, history of COVID-19 hospitalization ( 8/2020), migraines, nonalcoholic fatty liver disease, GERD, pre-diabetes",,"iodinated contrast (rash, itching)","['Anaemia', 'Asthenia', 'Computerised tomogram abnormal', 'Death', 'Disseminated intravascular coagulation', 'Haemoglobin decreased', 'Hepatic function abnormal', 'Metastases to liver', 'Oedema peripheral', 'Pain', 'Petechiae', 'Platelet count decreased', 'Purpura', 'Transfusion', 'Vaginal haemorrhage', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1032165,NV,36.0,F,"2/6 I had the 2nd Moderna vaccine. On 2/7-2/8 I had body aches, chills, and 99.4F temp. On 2/9 those symptoms subsided, but I started to get right-sided flank pain with pain on inhalation. I took acetaminophen and ibuprofen around the clock, used a heating pad on 2/9 and 2/10, but pain progressed. Mid-day on 2/10 the pain was so severe, I went to urgent care. They said it was gastritis and released me. I went back 2 hours later and saw a different doctor. He diagnosed me with a pulmonary embolism, pulmonary infarction, and pleural effusion. I was sent by ambulance to the hospital and admitted. I was treated for pain and started on Eliquis. I was discharged the evening of 2/12. The morning of 2/13, I woke up with 100.6 F Temp and 85% O2 at. I went to urgent care again, they thought I had pneumonia and referred me to the hospital. I was admitted to a different hospital on 2/12 and continue to antibiotic s and a heparin drip",Not Reported,,Yes,Yes,5.0,Not Reported,N,02/06/2021,02/09/2021,3.0,PUB,"Escitalopram, Prenate Mini, Loratadine, Vitamin D3, Fluticasone nasal spray",None,"Allergic rhinitis, Asthma, Depression, Anxiety, Lactation, Anti-thrombin III Deficiency",,Penicillin,"['Body temperature increased', 'Chills', 'Computerised tomogram thorax', 'Echocardiogram', 'Electrocardiogram ambulatory', 'Flank pain', 'Laboratory test', 'Pain', 'Painful respiration', 'Pleural effusion', 'Pulmonary embolism', 'Pulmonary infarction', 'SARS-CoV-2 test negative', 'Ultrasound Doppler']",2,MODERNA,IM 1032230,KY,66.0,M,"Muscle aches, particularly neck; swollen lymph nodes left supraclavicular; headache; fatigue. These symptoms lasted for approximately two weeks.",Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,08/19/2020,08/20/2020,1.0,PHM,"Levothyroxin, 50 mg",None,None,,None known,"['Fatigue', 'Headache', 'Lymphadenopathy', 'Myalgia']",2,GLAXOSMITHKLINE BIOLOGICALS,IM 1032252,CA,96.0,M,Resident tested COVID-19 confirmed positive a few days after covid vaccination.,Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/26/2021,19.0,SEN,MetFORMIN HCl Tablet 500 MG bid with meals GlipiZIDE Tablet 5 MG bid ac meals PROSTAT SUGAR FREE 30cc tid ROBITUSSIN DM 10ml q4hrs prn Lipitor Tablet 10 MG (Atorvastatin Calcium qd at 5pm NX: DIABETIC ICE CREAM (EXTRA DESSERT) two times a,Loss of appetite and generalized body weakness,DM Type 2,,No known allergies,"['COVID-19', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1032255,VA,40.0,M,"Within a few days of the first dose of the vaccine patient noticed extreme thirst, then increased urination frequency. Patient noticed unintended weight loss starting 2 weeks after first dose, and totaled 20 pounds in 5 weeks. Patient noticed some burry vision at night. Symptoms seems to lessen 2-3 weeks after first dose, but returned with increased intensity after second dose. Patient consulted a physician and lab work and blood sugar testing was ordered. Blood sugars were as high as 400 and A1C of 11. Patient went on a low extremely low carb no sugar diet for three days while waiting to see physician. Patient continued to monitor blood sugars. Blood sugars started to lower remained in the 170-260 range. Physician ordered repeat lab work and suspects Adult Onset Type 1 diabetes. Patient was placed on a long acting and quick acting insulin on 2-15-21. 23 Days after second dose.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/02/2021,01/05/2021,3.0,SEN,Airborn gummy vitamins,none,none,,none,"['Abnormal loss of weight', 'Blood glucose increased', 'Blood thyroid stimulating hormone', 'Glycosylated haemoglobin increased', 'Lipids', 'Metabolic function test', 'Pollakiuria', 'Thirst', 'Type 1 diabetes mellitus', 'Vision blurred']",2,PFIZER\BIONTECH,SYR 1032265,CA,89.0,F,"Resident tested NEGATIVE for COVID-19 last 1/25/2021. She was on monitoring for desaturation and low blood pressure on Jan. 27,2021",Yes,01/29/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/27/2021,20.0,SEN,PROSTAT SUGAR FREE Give 30 cc orally three times a day for SUPPLEMENT WITH MEDPASS TO PROVIDE 45G DSS 100 MG Give 1 tablet orally one time a day for (STOOL SOFTENER) HOLD FOR LBM HEALTHSHAKE 4OZ. PO three times a day for (SUPPLEMENT) BET,NONE,ANEMIA DEMENTIA HYPERLIPIDEMIA HYPERTENSION GERD,,NKA,"['Hypotension', 'Oxygen saturation decreased', 'SARS-CoV-2 test negative']",1,MODERNA,IM 1032279,CA,86.0,F,Resident tested NEGATIVE for COVID-19 on 1/25/2021. She was on monitoring for declining in condition on 1/29/2021.,Yes,01/29/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/29/2021,22.0,SEN,Vitamin C Tablet 500 MG (Ascorbic Acid) Give 1 tablet orally two times a day for (SUPPLEME NX: ICE CREAM two times a day @ LUNCH AND DINNER HEALTHSHAKE 4OZ. PO three times a day for SUPPLEMENT BETWEEN MEALS ARTIFICIAL TEARS Instill 1 dr,NONE,ATHEROSCLEROTIC HEART DSE DEMENTIA HLD,,NKA,"['General physical health deterioration', 'SARS-CoV-2 test negative']",1,MODERNA,IM 1032288,FL,80.0,M,"Bleeding into the retina of his left eye, obscuring vision Received injection of Avastin into left eye the next day No improvement yet We understand this could easily have been the natural course of his previously diagnosed macular degeneration, it?s just that he hadn?t bled in many years, and never in that eye, and after recently getting covid injection and it being experimental we thought we should report it in case",Not Reported,,Not Reported,Not Reported,,Yes,N,02/05/2021,02/11/2021,6.0,OTH,Eliquis Clonazepam Lexapro,None,Atrial fibrillation history Anxiety BPH Macular Degeneration,,Nka,"['Retinal haemorrhage', 'Visual impairment']",2,MODERNA,IM 1032301,CA,87.0,F,"TUES: Approximately 8 hours after the Covid shot, patient developed violent shaking, extreme pain throughout her body and became disoriented & confused. She did not have a fever. At 9:30 pm the home health nurse said to give Pt Tylenol which we didn't have so she said give her 2 Advil. At 11:30 pm Patient fell asleep. WEDS: Patient awoke 1:30 am. Her pain was still very bad and she was confused. She was given 2 advil. At 3:30 am she fell asleep. At 8:30 am she awoke and couldn't recall anything that had happened. Her mental state appeared to be better, however, the situation quickly deteriorated. She became agitated, began hallucinating and repeating what said to her, and started calling objects by the wrong names. The overall body pain seemed to have subsided. At 4:00 pm the home health nurse came by to take her vitals, which were all normal. At 7:00 pm Dr. prescribed an anxiety medication. THURS: Patient awoke at 12:30 am. She was confused, combative and unable to follow instructions. The paramedics were called and she was taken to hospital. She remained in the hospital through Sunday and was transferred to a Board & Care facility because she currently needs 24 hour care. MON: Mental state appears to be improving however, she has tactile sensitivity (painful to the touch) throughout her body.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/09/2021,02/09/2021,0.0,PHM,Benazepril hydorcholoride 5MG - daily; Carbidopa 25MG/Levodopa 100MG - 3x daily; Donepezil hydrochloride 10MG - at bedtime; Myrgetriq 50MG - daily; Triamcinolone Acetonide .25MG topical - daily,None,,,None known,"['Activated partial thromboplastin time', 'Aggression', 'Agitation', 'Blood magnesium', 'Blood phosphorus', 'Chest X-ray', 'Computerised tomogram head', 'Condition aggravated', 'Confusional state', 'Culture urine', 'Disorientation', 'Disturbance in attention', 'Full blood count', 'Hallucination', 'Hyperaesthesia', 'Memory impairment', 'Metabolic function test', 'Pain', 'Prothrombin time', 'SARS-CoV-2 test', 'Speech disorder', 'Tremor', 'Troponin I', 'Urine analysis']",1,MODERNA,IM 1032303,CA,83.0,F,"On monitoring for declining in condition, loss of appetite and generalized body weakness on2/1/2021. Was confirmed COVID-19 positive 4/23/2020.",Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,02/01/2021,25.0,SEN,"PUREED diet, Pureed texture DIET: DOUBLE PORTION @ ALL MEALS DIET: EXTRA PROTEIN ENTREE three times a day @ BREAKFAST, LUNCH AND DINNER NX: GLUCERNA 1.5 120CC three times a day for (SUPPLEMENT) WITH MEDPASS Zinc Sulfate Tablet 220 (50 Zn)","On monitoring for declining in condition, loss of appetite and generalized body weakness on2/1/2021",Hemiplegia & Hemiparesis on left non-dominant side Atherosclerotic heart Dse. Type 2 Diabetes Mellitus Cerebral Infarction PAF Thyroid Disorder Hypertension Cerebral edema GERD Occipital Neuralgia,,NKA,"['Asthenia', 'Condition aggravated', 'Decreased appetite', 'General physical health deterioration', 'SARS-CoV-2 test negative']",1,MODERNA,IM 1032321,CA,87.0,M,Resident has shortness of breath on 1/19/2021 and was transferred to Hospital 1/20/2021,Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/19/2021,12.0,SEN,"Regular diet, Regular texture NX: 2CAL HN 120CC 1 CAN PO three times a day WITH MEDPASS DIET: RICE PORRIDGE ALL MEALS PER RESIDENT'S REQUEST three times a day NX: 4OZ. HEALTHSHAKE PO three times a day BETWEEN MEALS Docusate Sodium Capsu",none,Wedge Compression Fracture of T-11-T12 Atrial Fibrillation BPH GERD,,NKA,['Dyspnoea'],1,MODERNA,IM 1032327,CA,89.0,F,On monitoring for weight loss .,Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/11/2021,7.0,SEN,"PUREED diet, Pureed texture NX: ICE CREAM (EXTRA DESSERT) two times a day @ LUNCH AND DINNER PROSTAT SUGAR FREE Give 30 cc orally two times a day for SUPPLEMENT WITH MEDPASS TO PROVIDE 30GRAMS PROTEIN AND 200CNX: HEALTHSHAKE 4OZ. PO thre",None,Heart Failure Chronic Kidney Dse. Dementia Atheroschlerotic Heart Dse. Anemia Hypothyroidism Major Depressive Disorder Nonrheumatic aortic valve stenosis Cardiomegaly Hypertension Dysphagia Osteoporosis,,"Fosamax, Linzess","['SARS-CoV-2 test negative', 'Weight decreased']",2,MODERNA,IM 1032611,AZ,96.0,F,"Fever of 104.5 at 330am. Reduced to 101.5 by 500am with Tylenol. Collasped at 830am on the floor unable to verbalize or move, 02sat =72. EMTs were called, checked vitals and transported to the ER.",Not Reported,,Yes,Yes,6.0,Not Reported,Y,02/03/2021,02/04/2021,1.0,PVT,"Amlodipine, presdnisone, B12,",none,"High blood pressure, A Fib",,"Penicillin, Morphine","['Aphasia', 'Immobile', 'Pyrexia', 'SARS-CoV-2 test negative', 'Syncope']",1,MODERNA,IM 1032572,MA,34.0,F,"shortness of breath; throat tightness; HR 133/HR 137; diarrhea; hives around injection site; Hives around i njection site and on contralateral arm and chest; flushing sensation; felt anxious; BP 131/87/ BP 131/85/BP 145/76; A spontaneous report was received from a nurse concerning a 34-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced flushing feeling, felt anxiety, blood pressure fluctuation, hives around injection site and contralateral arm and chest, diarrhea, shortness of breath, throat tightness and heart rate abnormal. The patient's medical history included anxiety and attention deficit hyperactivity disorder. Concomitant product use was not provided. On 09 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in her arm for prophylaxis of COVID-19 infection. On 09 Jan 2021 at 13:30, immediately after receiving the Moderna COVID-19 vaccine, the patient reported having a flushing sensation and felt anxious. At 13:36 the patient's vital signs included blood pressure 131/87 mmHg, heart rate 99 beats/min, and oxygen saturation 99%. Doctor noted hives around the injection site and on contralateral arm and chest. Patient was moved to a separate room to lie down on a bed; on route to the new room, the patient developed diarrhea. Treatment included diphenhydramine. At 13:49, the patient reported having shortness of breath and throat tightness. 99%. Intramuscular epinephrine was given and 911 called. The patient's vital signs included heart rate 133 beats/min and oxygen saturation At 13:55, the patient's vital signs included blood pressure 145/76 mmHg, heart rate 137 beats/min, and oxygen saturation 99% At 14:00, emergency medical services arrived, and patient was transferred to hospital. Patient left the office in stable condition with vital signs within expected range and fully conscious. Action taken with mRNA-1273 in response to the events was not provided. The events, flushing feeling, felt anxiety, blood pressure fluctuation, hives around injection site and contralateral arm and chest, diarrhea, shortness of breath, throat tightness and heart rate abnormal, were considered resolved.; Reporter's Comments: A spontaneous report concerns a 34-year-old, female patient who experienced serious events of shortness of breath, throat tightness and heart rate increased and non-serious events of flushing feeling, felt anxiety, blood pressure fluctuation, hives around injection site and contralateral arm and chest and diarrhea. The events occurred on the same day after the administration of the first dose of mRNA 1273 (Lot # 026L20A, expiration date unknown). Treatment administered include diphenhydramine and epinephrine. Outcome is resolved. Based on the information provided, which indicates a strong temporal association of the reported events with the administration of mRNA-1273 vaccine, a causal association cannot be excluded. The event of hives around injection site is consistent with the known safety profile of mRNA 1273 vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,UNK,,ADHD; Anxiety,,,,"['Anxiety', 'Blood pressure fluctuation', 'Blood pressure measurement', 'Diarrhoea', 'Dyspnoea', 'Flushing', 'Heart rate', 'Heart rate increased', 'Injection site urticaria', 'Oxygen saturation', 'Throat tightness', 'Urticaria']",1,MODERNA,OT 1032574,TX,,M,"Flu-like symptoms; fever; chills; headaches; myocarditis; A spontaneous report was received from a physician concerning a middle-aged, male patient, who received Moderna's COVID-19 Vaccine, and who experienced myocarditis, flu-like symptoms, fever, chills and headache. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 26 Jan 2021, approximately three days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced flu-like symptoms, fever, chills and headache. On 29 Jan 2021, the patient developed substernal chest pain and came to the ED for evaluation. His troponins were elevated, but his cardiac catheterization was negative for acute coronary occlusion. Cardiac MRI findings were consistent with myocarditis and evaluation for covid 19 disease by PCR and serology were negative. Additional workup for other causes of myocarditis is still pending. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events myocarditis, flu-like symptoms, fever, chills and headache was not provided.; Reporter's Comments: This case concerns a male patient, with prior cardiac risk factors, who experienced a serious event of myocarditis along with other non-serious events after receiving second dose of mRNA-1273 (Lot# unknown). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/29/2021,3.0,UNK,,,Medical History/Concurrent Conditions: Cardiovascular risk (Prior cardiac risk factors),,,"['Catheterisation cardiac', 'Chills', 'Headache', 'Influenza like illness', 'Magnetic resonance imaging', 'Myocarditis', 'Pyrexia', 'SARS-CoV-2 test', 'Serology test', 'Troponin']",UNK,MODERNA,OT 1032575,NV,56.0,F,"Two days later passed away; difficulty breathing, shortness of breath; difficulty breathing, gurgling; Not feeling well; Achiness; Severe fever; Chills; A spontaneous report was received from a physician concerning a 56-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever, chills, achiness, shortness of breath, gurgling and unresponsive. The patient's medical history was not provided. Concomitant product use was not provided. On 19 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. After receiving the vaccine on 19 Jan 2021, the patient experienced fever, chills, shortness of breath, gurgling and achiness. On 21 Jan 2021, the patient was found unresponsive. Emergency medical services were called to perform life saving measures however, they were unsuccessful. No further treatment information was provided. The patient died on 21 Jan 2021. The cause of death was reported as unknown. An autopsy was planned.; Reporter's Comments: This case concerns a 56-year-old, female, who experienced a serious event of death, with many other events after receiving second dose of mRNA-1273 (Lot# 042L20A). Very limited information regarding these events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death",Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Chills', 'Death', 'Dyspnoea', 'Malaise', 'Myalgia', 'Pyrexia', 'Respiration abnormal']",2,MODERNA,OT 1032578,IA,70.0,M,"left hand was paralyzed; muscles got real weak, hands real weak then could feel it in legs,but not as bad as arms; nauseous; A spontaneous report was received concerning a 70 year old male consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced monoplegia, muscle weakness and nausea. The patient's medical history was not provided. Concomitant product use was not provided. On 01 Feb 2021, prior to the onset of events, the patient received his first of two planned dose of mRNA-1273, (batch number 013L20A), intramuscularly into his left arm for prophylaxis of Covid-19 infection. The patient received his first dose of mRNA-1273 at the hospital which is 3 hours away from his home. While driving home, the patient's ""muscles got real weak"". His left hand was ""like paralyzed"". ""He couldn't move his fingers"". Then if he moved his wrist down, his wrist would ""lock up"". He had his hands on the steering wheel, he could tell they were ""real weak and wanted to fall"". Then he could ""feel it in his legs, and they weren't as bad as his arms"". He had his foot on the accelerator and was ""worried"". He was ""real nauseous"". It was ""real scary"", and he was ""praying a lot"". The symptoms lasted about 4 hours in total. Two hours while driving home and two hours after arriving home. He stated he had no other reaction. No medical tests or treatment were reported. Action taken with mRNA-1273 in response to the event was not provided. The events, monoplegia, muscle weakness and nausea, were resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,MIL,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Monoplegia', 'Muscular weakness', 'Nausea']",1,MODERNA,OT 1032596,,,M,"On Saturday little blood clot, no liquid blood, and this morning this same; a little blood in the urine; This is a spontaneous report from a contactable consumer (the patient). A male patient (Age: 77, Unit: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history included little blood clot, no liquid blood, 7 years ago (unspecified date in 2014). The patient's concomitant medications included fish oil and acetylsalicylic acid (ASPIRIN). The patient stated he received the first dose of the COVID shot on Thursday (unspecified date). The next morning, there was a little blood in the urine. On Saturday, little blood clot, no liquid blood, and this morning the same. The patient had this before 7 years ago. The patient asked if anyone else reported this and for information. The clinical outcome of little blood clot and a little blood in urine was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,FISH OIL; ASPIRIN,,Medical History/Concurrent Conditions: Blood clot in urine (7 years ago),,,"['Blood urine present', 'Haemorrhage urinary tract', 'Urine analysis']",1,PFIZER\BIONTECH, 1032658,PA,47.0,M,Had daily headaches after first dose of vaccine. For 3 weeks. Decided to skip the second dose because of that. Then had leg pain after nearly a month of the vaccine. Thought it was muscle pain but landed up in ER with shortness of breath and was diagnosed with DVT and large PE.,Not Reported,,Yes,Yes,2.0,Not Reported,N,12/30/2020,02/07/2021,39.0,PVT,None,None,None,,None,"['Computerised tomogram', 'Deep vein thrombosis', 'Dyspnoea', 'Fibrin D dimer', 'Headache', 'Pain in extremity', 'Pulmonary embolism', 'Ultrasound scan']",1,PFIZER\BIONTECH,IM 1032662,UT,86.0,M,Death,Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/05/2021,11.0,PUB,,Absolutely none. Unusually healthy for 86,None,,,['Death'],1,PFIZER\BIONTECH,SYR 1032693,,26.0,M,"26 yo Male developed a laboratory confirmed myocarditis on/about 7 February 2021 after receiving the 2nd dose of Moderna COVID19 Vaccine on 3 Feb 2021. His HS-Tropin peaked at 2179. He was admitted to the ICU for care. Discharged at 72 hour admission. Seen today (16 Feb 2021) for follow-up. Reports no sequela other than the development of dry skin that is pruritic. Multiple pending lab studies ordered/collected to identify other etiologies (Lyme, RPR, Coxsackie, parvo ...). Denies any vaping products.",Not Reported,,Yes,Yes,4.0,Not Reported,U,02/03/2021,02/07/2021,4.0,MIL,None,None,None,,None,"['C-reactive protein normal', 'Drug screen negative', 'Dry skin', 'Intensive care', 'Myocarditis', 'Pruritus', 'Red blood cell sedimentation rate increased', 'Troponin increased']",2,MODERNA,IM 1032863,,42.0,F,"Several hours after vaccine #2, developed severe headache, myalgias and vomiting. Seen in ED on 2/3/21 and admitted to hospital for pain and nausea control.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/05/2021,02/05/2021,0.0,PVT,,,,,,"['Headache', 'Myalgia', 'Nausea', 'Pain', 'Vomiting']",2,MODERNA,IM 1032865,GA,70.0,F,4am (1/29/2021) extreme sweating to the point of soaking the hair on head; extreme dizziness with vertigo and inability to stand up or walk straight leading to nausea and vomiting 11am( out of bed) needed assistance to chair bc of vertigo and vision impairment; spent most of day seated; cont to require assistance with any walking 9pm to bed 8am(1/30/2021) Wake up and all symptoms worse. Unable to walk without assistance and had a severe body lean to left. Husband called doc and they suggested calling 911 to get to ER ASAP 1130 Arrived at hospital ER and was subsequently diagnosed and admitted with a cerebellar stroke,Not Reported,,Not Reported,Yes,14.0,Yes,N,01/28/2021,01/29/2021,1.0,PVT,Biotin Ocuvite Aspirin Calcium vit D Atorvastatin(Lipitor) Meloxicam(Mobic) Telmisartan(Micardis) Cyanocobaltamin(B12),None,Highblood pressure Arthritis High cholesterol,,None,"['Barium swallow', 'Cerebellar stroke', 'Computerised tomogram', 'Dizziness', 'Dysstasia', 'Gait disturbance', 'Hyperhidrosis', 'Nausea', 'Posture abnormal', 'Vertigo', 'Visual impairment', 'Vomiting']",1,MODERNA,IM 1032873,FL,92.0,M,"He had rigors starting 6 pm the day after the vaccination. He was treated with one 500 mg tylenol. He had increased wheezing but did not complain of SOB. At 0400 the next morning, he died.",Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/14/2021,1.0,PHM,"Aspirin, Lipitor, Calcium, Plavix, Cardura, Finasteride, Prozac, Metoprolol, Sinemet, Januvia, Flomax, Vitamin B12, Vitamin C, Vitamin D3","Had Covid 19 in Dec. 2020, Tested negative at beginning of Feb. 2021. No other illness.",Type 2 diabetes. Controlled hypertension.,,NKA,"['Chills', 'Death', 'Wheezing']",1,MODERNA,IM 1032880,KY,78.0,F,"Received Pfizer 1/22/2021. RNA+ 2/4/2021. S/S SOB, cough, confusion. COVID assoc. resp. failure, stage 4 lung cancer, COPD, HTN, former smoker. patient in hospice and died 2/10/2021.",Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,02/04/2021,13.0,OTH,"Proair , Pulmicort , Neds, Tegertol, Plavix , Flonase, Tofranil, Kepra , Protonix Trental Opdivo, Colace, Sim Vastatin, Vit E,",Hospice Chronic COPD,"Cancer chest pain COPD Cough , HX of Radiation and Chemotherapy Hypercholestemia , HTN, Seizure , Shingles, SOB",,"Phenergan, Codeine","['COVID-19', 'Condition aggravated', 'Confusional state', 'Cough', 'Death', 'Dyspnoea', 'Hypertension', 'Lung carcinoma cell type unspecified stage IV', 'Respiratory failure', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1032920,MI,73.0,F,"Heart rate at 107; Stomach issue; Nausea; Chills; Passed out; Dizzy; Temperature; Hands were shaking; Sweating profusely; A spontaneous report was received from a consumer who is a 73 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, dizzy(dizziness), temperature(temperature abnormal), hands were shaking(tremors), passed out(loss of consciousness), sweating profusely(hyperhidrosis), nausea, heart rate at 107(heart rate increased) and stomach discomfort(abdominal discomfort). The patient's medical history, as provided by the reporter included breast cancer. No concomitant medications were reported. On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient experienced chills, dizzy, temperature, hands were shaking, passed out and sweating profusely. The treatment for the events included paracetamol. On an unknown date, the patient experienced, nausea, heart rate at 107 heartbeats per minute and stomach discomfort. The treatment for the events included paracetamol. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, chills, dizzy, temperature, hands were shaking, passed out, sweating profusely, nausea, heart rate at 107 and stomach discomfort was unknown.; Reporter's Comments: This case concerns a 73-year-old female patient, who experienced serious event of loss of consciousness and non-serious events of chills, dizziness, temperature abnormal, tremors, hyperhidrosis, nausea, heart rate increased, and abdominal discomfort. The reported events occurred on the same day after first dose of mRNA-1273, (lot # 029L20A) with the exception of nausea, heart rate increased, and abdominal discomfort which occurred at unknown date. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Breast cancer; Radiation therapy (Breast cancer radiation therapy),,,"['Abdominal discomfort', 'Body temperature abnormal', 'Chills', 'Dizziness', 'Heart rate', 'Heart rate increased', 'Hyperhidrosis', 'Loss of consciousness', 'Nausea', 'SARS-CoV-2 test', 'Tremor']",1,MODERNA,OT 1032994,AZ,74.0,M,Received 1st. Pfizer vaccine shot at 10:00 am Thursday 2/10/2021 At approximatly 6:00 pm same day I started to have severe pain in my side shortness of breath and could not lie down to go to sleep. Had to go to bed sitting up with three pillows on my back. The next morning went to doctor who ordered blood test and chest X-Ray. Chest X-Ray indicated Pulmonary Embolism. Doctor started me on Eliquis blood thinner to hopefully desolve the blood clot on my lung. Doctor suggested I report Pulmonary Embolism occuring same day as my first vaccine shot. Do not know if shot caused Pulmonary Embolism or just a coinsidence. In addition doctor found blood in my urine and a CT of Bladder has been ordered,Not Reported,,Yes,Not Reported,,Not Reported,N,02/10/2021,02/10/2021,0.0,OTH,"Losarten, Multiple Vitamin, Calcium, Vitamin C, B-12, Super B, CoQ10, Vitamin D, Glucosamine/Condroiten.",None,None,,Penicillian,"['Blood test', 'Blood urine present', 'Chest X-ray abnormal', 'Dyspnoea', 'Fibrin D dimer', 'Mobility decreased', 'Pain', 'Pulmonary embolism', 'Scan with contrast', 'Sleep disorder', 'X-ray with contrast']",UNK,PFIZER\BIONTECH, 1033014,WI,64.0,M,"Pt received first dose of Pfizer COVID-19 vaccine on 2/6/2021. Pt subsequently developed symptoms of COVID-19 and presented to the ER on 2/15/2021. Chief complaint was cough, fever, and shortness of breath. Reports that he had a negative nasal swab as recently as 2 weeks ago. Reported that symptoms of cough, sob, and weakness started 3 days prior to presenting at ER (2/12/2021). Chest Xray had features of bilateral pneumonia. Pt is still currently inpatient at our hospital, receiving treatment for COVID-19, including dexamethason and remdesivir. He is currently receiving 3L of supplemental O2 via NC.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/06/2021,02/15/2021,9.0,PUB,"albuterol inhaler (PRN), aspirin, gabapentin, glipizide, metformin, omeprazole, simvastatin",,"Tobacco abuse, TB lung, latent, sebaceous carcinoma, presbyopia, incipient senile cataract, hyperlipidemia, GERD, diabetic polyneuopathy, DM 2, chronic low back pain",,No known allergies per medical record,"['Asthenia', 'COVID-19', 'COVID-19 pneumonia', 'Chest X-ray abnormal', 'Cough', 'Dyspnoea', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1033049,,70.0,U,"Pt experienced severe hypoglycemic event (POC=38) following his first COVID-19 vaccine dose. He was found driving the wrong way down the highway with no memory of the event once stopped by authorities. He was admitted with hypoglycemia and chest pain. His home diabetes coverage is an insulin pump and there was denial of decreased PO intake. The insulin pump was stopped once the pt was admitted. His glucose improved and insulin regular SSI was initiated. He was brought for cardiac cath 2/2 with no new issues seen. The patient stabilized, was set for follow-up with PCP and endocrinologist and discharged 2/4.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/01/2021,02/01/2021,0.0,PVT,,,,,,"['Amnesia', 'Catheterisation cardiac normal', 'Chest pain', 'Hypoglycaemia', 'Impaired driving ability']",1,PFIZER\BIONTECH,IM 1033050,FL,83.0,F,Upper arm pain from elbow to shoulder and throbbing. Some swelling in lower arm near wrist. Considering Urgent Care Visit,Not Reported,,Yes,Not Reported,,Not Reported,N,02/13/2021,02/14/2021,1.0,PHM,"Lutein vitamin 20mg once daily, Calcium,""1000mg Magnesium 400 mg, Zinc 15 mg once daily, , BioCell Collagen ""chicken sternal cartilage"" 1000mg, etc. Turmeric Extract 1160 mg ""black pepper extract"" Nature's Bounty Hair, Skin, Nails twi",none,none,,none,"['Arthralgia', 'Pain', 'Pain in extremity', 'Peripheral swelling']",UNK,MODERNA, 1033056,MD,36.0,M,"Patient developed sudden onset vertigo with recurrent vomiting. He was brought to the emergency department and was evaluated under the stroke protocol and underwent CT, CTA, and MRI of the brain which did not reveal an etiology of his symptoms. He had a neurology consultation and the most likely cause was thought to be vestibular neuritis on the left side. He was treated with Zofran, Reglan, Meclizine, IV fluids, and Valium with partial relief and was discharged home with outpatient follow-up. Symptoms are unresolved at the time of this report.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/28/2021,02/15/2021,18.0,PVT,Novolog Jardiance Atorvastatin Zyrtec,,Type 1 Diabetes Mellitus Hyperlipidemia Mild Intermittent Asthma,,none,"['Angiogram cerebral normal', 'Blood magnesium normal', 'Blood phosphorus normal', 'Chest X-ray normal', 'Coagulation test normal', 'Computerised tomogram head normal', 'Electrocardiogram normal', 'Full blood count abnormal', 'Leukocytosis', 'Magnetic resonance imaging brain normal', 'Metabolic function test', 'SARS-CoV-2 test negative', 'Troponin', 'Urine analysis', 'Vertigo', 'Vestibular neuronitis', 'Vomiting']",1,MODERNA,IM 1033064,KY,42.0,F,"Diabetic ketoacidosis without coma associated with type 2 diabetes mellitus (CMS/HCC) (2/15/2021) POA: Yes Active Problems: Uncontrolled type 2 diabetes mellitus with hyperglycemia, with long-term current use of insulin (CMS/HCC) (5/6/2016) POA: Not Applicable Lactic acidosis (2/15/2021) POA: Yes Vaccination reaction - suspected (2/15/2021) POA: Yes Hyponatremia (2/15/2021) POA: Yes Was admitted to the ICU for further treatment",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/11/2021,02/15/2021,4.0,PVT,,,"Anxiety/depression, DM, Hypertension, Neuropathy, obstructive sleep apnea, nonalcoholic fatty liver disease, nonalcoholic steatohepatitis,",,Sulfa and Tramadol,"['Anion gap increased', 'Blood creatinine increased', 'Blood glucose increased', 'Blood lactic acid increased', 'Blood urea increased', 'Carbon dioxide decreased', 'Condition aggravated', 'Diabetic ketoacidosis', 'Glomerular filtration rate decreased', 'Hyperglycaemia', 'Hyponatraemia', 'Intensive care', 'Lactic acidosis', 'Type 2 diabetes mellitus', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 1033078,OH,45.0,F,"History of anaphylaxis to IV Taxol in her past. She did well after her first dose of the Covid vaccine, Within 10 minutes of receiving her second dose of Covid vaccine she c/o throat tightness, lightheadedness, flushed/warm sensation in her chest, C/O of SOB. She was injected with Epi, given Benadryl 25mg po, Zyrtec 10mg po. A CODE Blue was called and she was transported to the ED where she received a second Epi injection. She was monitored in the ED overnight, was given Benadryl every 6 hours, treated with prednisone and pepcid and Tylenol for headache. Was discharged from the ED the next morning and given Rx for prednisone, benadryl, pepcid for 5 days and and Epi pen.",Not Reported,,Not Reported,Yes,12.0,Not Reported,Y,02/11/2021,02/11/2021,0.0,WRK,"Humalog for insulin pump, losartan, oxybutynin, metformin, paxil, atorvastatin.",,"Diabetes, breast cancer, anxiety/depression",,"Sulfa, taxol, taxatire","['Blood glucose', 'Cardio-respiratory arrest', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Feeling hot', 'Flushing', 'Headache', 'Mixed anxiety and depressive disorder', 'Throat tightness']",2,MODERNA,IM 1033091,WI,58.0,F,"approximately 2.5 wks after vaccination, development of severe increasing back pain and chest pain and shortness of breath Dx acute moderately severe pericarditis with pericardial effusion, pneumonitis with bilateral small pleural effusions, hepatitis with elevated alk phos and LFT, bone marrow reaction with elevated WBC, new anemia and elevated platelets, markedly elevated d dimer and CRP with normal troponin and negative imaging for PE.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/04/2021,01/22/2021,18.0,PVT,"Zinc, vit D3, vit C","None, was exposed to Covid 19 just prior to getting the vaccination",None,,None,"['Back pain', 'Blood alkaline phosphatase increased', 'C-reactive protein increased', 'Chest pain', 'Computerised tomogram', 'Dyspnoea', 'Echocardiogram abnormal', 'Electrocardiogram', 'Fibrin D dimer increased', 'Full blood count abnormal', 'Hepatitis', 'Laboratory test', 'Liver function test abnormal', 'Liver function test increased', 'Pericardial effusion', 'Pericarditis', 'Platelet count increased', 'Pleural effusion', 'Pneumonitis', 'White blood cell count increased']",1,MODERNA,IM 1033102,WV,93.0,M,"Patient received first dose of vaccine on 1/7/21 at a community Public Health clinic. On 1/29/21 he received a second dose at the community Public Health clinic. On 2/5/21, the patient presented to the ED with complaints of shortness of breath worsening over the last 2 weeks. Patient reported that he had decreased exercise capacity and increased coughing with sputum production intermittently. Patient reported that he had been feeling chilled, but no fevers. Patient was admitted and treated with Decadron and Remdesivir. Patient experienced increased oxygen requirement. Patient was a DNI and did not want to be on life support. After discussion with the patient and family, patient was moved to comfort care. passed away on 2/11/21.",Yes,02/11/2021,Not Reported,Yes,6.0,Not Reported,N,01/07/2021,01/29/2021,22.0,PUB,"Aspirin, Lipitor, Cardura, Eliquis, Finasteride, Lasix Lisinopril Meloxicam Metoprolol Multivitamin Ranitidine",,"CAD, CKD",,NKA,"['COVID-19', 'Chest X-ray abnormal', 'Chills', 'Cough', 'Death', 'Dyspnoea', 'Feeling cold', 'Fibrin D dimer', 'Fibrin D dimer increased', 'Interstitial lung disease', 'Lung infiltration', 'Mobility decreased', 'Productive cough', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1033122,MD,47.0,M,"48 hours post vaccine, patient developed low grade fever and respiratory complaints including shortness of breath. chest x ray showed RUL consolidation. when patient wosened over the next 48 hours from respiratory standpoint including new oxygen requirement and hypotension, decision was made to perform chest ct which confirmed presence of RUL pneumonia. the following day, the patient was bronched and the resultant bronchial alveolar lavage that was performed has thus far been completely negative. repeat chest xray four days later showed resolution of RUL consolidation and patient was no longer symptomatic.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/07/2021,2.0,PVT,,,liver transplant,,,"['Blood culture', 'Bronchoalveolar lavage normal', 'Bronchoscopy', 'Chest X-ray', 'Chest X-ray abnormal', 'Computerised tomogram thorax', 'Dyspnoea', 'Hypotension', 'Laryngotracheobronchoscopy', 'Lung consolidation', 'Oxygen therapy', 'Pneumonia', 'Pyrexia', 'Respiratory disorder', 'Urine analysis']",1,MODERNA,IM 1033147,MN,42.0,M,"Tremors, feeling hot. Diagnosed with autoimmune disorder graves disease.",Not Reported,,Not Reported,Not Reported,,Yes,U,12/21/2020,01/01/2021,11.0,PVT,"Multivitamin, aspirin 81mg",None,None,,None,"['Anti-thyroid antibody positive', 'Autoimmune disorder', ""Basedow's disease"", 'Blood thyroid stimulating hormone decreased', 'Feeling hot', 'Tremor']",2,PFIZER\BIONTECH,IM 1033151,NE,57.0,M,"sore throat, congestion, fever. 01/02/2021: COVID positive. Given Balmlinivimab and Decadron. Admitted to hospital through ER on !/5/2021 with chest tightness and shortness of breath. Throughout stay given Cardizem, Amiodarone without conversion. 1/5/2021 1800 transported by ambulance to medical center. Cardioverted at medical center.",Not Reported,,Yes,Not Reported,,Not Reported,Y,12/22/2020,01/02/2021,11.0,UNK,,,,,,"['COVID-19', 'Chest discomfort', 'Dyspnoea', 'Nasal congestion', 'Oropharyngeal pain', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1033152,CA,53.0,F,"Chills, aches, post dose 2 and left sick within 24 hours of receiving the injection but was fine approximately 16 hours post injection. On or about 2/03/2021 felt intense itching deeply in left flank area. On 2/52011 the pain became so intense that I missed work and went to the hospital, and had concerns there was a problem with my kidneys. On 2/9 itching, urning and pain in left flank area and later developed shingles for the first time.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/21/2021,02/03/2021,13.0,PVT,"Antihistamine Zyrtec,Singular, cyclosporine, lasix, potassium, cetirizine, fluoxetine,fenofibrate...daily regimen for both dose 1 and 2",Chronic autoimmune urticaria with angeoedema,See above Developed shingles,,"Shellfish, whey, multiple fruits,","['Burning sensation', 'Chills', 'Computerised tomogram', 'Flank pain', 'Herpes zoster', 'Impaired work ability', 'Laboratory test', 'Malaise', 'Pain', 'Pruritus', 'Renal disorder', 'Urine analysis']",2,MODERNA,IM 1033155,SD,64.0,M,"Vaccine given in clinic per protocol - patient monitored for 15 minutes, no adverse reactions noted at the time. Patient stated he felt fine following 15 minute monitoring time. Patient left facility- it was later reported that pt had a fall at home. Upon review of pt's medical record - Pt's wife had to initiate CPR and call EMS for transportation and life saving measures enroute to the Emergency Room. Pt was intubated as pt was in asystole upon arrival to the ER, ACLS was continued, pt was noted to have a traumatic brain injury from his fall at home, and pt was pronounced dead at 1620.",Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,PVT,"Amiodarone, Rosuvastatin, Prevacid, Zetia, ASA, MVI, Nitroglycerin, Metformin, Potassium, Bumex, Apixaban, Omega 3, Metoprolol, Midodrine,","Generalized ischemic myocardial dysfunction, lower leg edema with cellulitis","Ischemic Cardiomyopathy, Diabetes, Combined Systolic/Diastolic Heart Failure, Edema, Ventricular Tachycardia, Pacemaker, Stroke, Myocardial Infarction, Hyperlipidemia, Hypertension, Obesity, Coronary arteriosclerosis, Paroxysmal atrial fibrillation, Left ventricular thrombus, Cardiorenal Sydrome, Bilateral lower leg cellulitis",,No known allergies,"['Cardiac arrest', 'Craniocerebral injury', 'Death', 'Endotracheal intubation', 'Fall', 'Resuscitation']",1,MODERNA,IM 1033184,OH,53.0,F,"Vasculitis on her head, at the back of the brain; Horrible pain in the neck; Pain on the back; Feeling dizzy; Motion sickness; Vertigo; Horrible headaches; raging headache; Nausea; awful nausea; feeling tired, fatigue; Sore arm; Body aches; A spontaneous report was received from a 53-year-old, female, patient who was also a physician who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vasculitis on her head, at the back on the brain, sore arm, feeling tired; fatigue, body aches, awful nausea; nausea all day long, horrible headaches, motion sickness, feeling dizzy, horrible pain in the neck, vertigo, and pain on the back. There was no medical history provided. There were no concomitant medications reported. On 24 Dec 2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the left arm, for prophylaxis of COVID-19 infection. On 25 Dec 2020, the patient experienced sore arm, feeling tired, body aches, and fatigue, which continued through Sunday, 26 Dec 2021. On 27 Dec 2020, she began experiencing awful nausea, horrible headaches, vertigo, and motion sickness in addition to the ones she suffered before. On 28 Dec 2020, the patient experienced nausea all day long. On 29 Dec 2020, she went to the emergency room (ER) as she was feeling dizzy, had nausea, and had a raging headache. In the ER, she was given IV fluids, diphenhydramine hydrochloride, and other non-specified medications that helped with her symptoms. The patient went home with prescriptions and the next day she had results from lab work done, which included sedimentation rate was 44 (doubled) and her plaquette count was above normal. Treatment form her primary care physician included steroids, acetylsalicylic acid, meclizine hydrochloride, and prednisone. The patient reported an MRI was done and her physician told her she had vasculitis on her head, at the back on the brain. She was referred to a neurologist and was asked to do more bloodwork. On 12 Jan 2021, the patient reported she was still experiencing horrible pain in the neck, nausea, vertigo, dizziness, and pain on the back, with symptoms beginning on an undisclosed date. Action taken with mRNA-1273 to the events was not provided. The outcome for the events, vasculitis on her head, at the back on the brain, sore arm, feeling tired, fatigue, body aches, horrible headaches, and motion sickness, was unknown. The events, pain in the neck, nausea, vertigo, dizziness, and pain on the back, were considered not resolved.; Reporter's Comments: This case concerns a 53 year old female patient experienced a serious unexpected event of Central nervous system vasculitis and NS events of sore arm, feeling tired; fatigue, body aches, awful nausea; nausea all day long, horrible headaches, motion sickness, feeling dizzy, horrible pain in the neck, vertigo, and pain on the back. The events occurred few days after first dose of the study medication administration. Treatment included IV fluids, diphenhydramine hydrochloride, steroids, acetylsalicylic acid, meclizine hydrochloride and prednisone. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No adverse event, Continue: [UNK], Comment: No reported medical history",,,"['Back pain', 'Central nervous system vasculitis', 'Dizziness', 'Fatigue', 'Headache', 'Magnetic resonance imaging', 'Motion sickness', 'Nausea', 'Neck pain', 'Pain', 'Pain in extremity', 'Platelet count', 'Red blood cell sedimentation rate', 'Vertigo']",1,MODERNA,OT 1033185,VA,,M,"Diarrhea with blood; Headache; Insomnia; A spontaneous report was received from a 63-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea with blood, headache, and insomnia. The patient's medical history was not included. Concomitant medications were not reported. On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number: 012L20A), intramuscularly for the prophylaxis of COVID-19 infection. On 07 Jan 2021, the patient experienced diarrhea with blood, headache, and insomnia for couple days. Treatment included aspirin for the headache after 3-4 days from getting the vaccine. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, diarrhea with blood was resolved on 08 Jan 2021 and the outcome of the events insomnia and headache was resolved on unknown dates. ; Reporter's Comments: Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Diarrhoea haemorrhagic', 'Headache', 'Insomnia']",1,MODERNA,OT 1033202,CA,71.0,M,Patient was hospitalized for Guillain-Barre syndrome,Not Reported,,Yes,Yes,27.0,Not Reported,N,01/19/2021,01/20/2021,1.0,PVT,? clonazePAM (KLONOPIN) 0.5 mg Oral Tab Take 1 and one-half tablets by mouth daily at bedtime ? Mirtazapine (REMERON) 15 mg Oral Tab Take 1 tablet by mouth daily at bedtime ? metFORMIN (GLUCOPHAGE XR) 500 mg Oral 24hr SR Tab Take 2 tablets,"STROKE. 2008 ? ATHEROSCLEROSIS OF AORTA cxr 8/11 ? BIPOLAR 1 DISORDER, UNSPECIFIED EPISODE � ? CAD (CORONARY ARTERY DISEASE) � ? DM 2 � ? GERD (GASTROESOPHAGEAL REFLUX DISEASE) � ? HYPOTHYROIDISM � ? PPD POSITIVE. s/p cataract surgery s/p tonsillectomy","As above, CAD, prior stroke (no deficits), bipolar disorder, and DM",Pneumococcal Vaccine,Pneumococcal Vaccine Quinine NSAIDs,"['CSF protein increased', 'Guillain-Barre syndrome', 'Magnetic resonance imaging brain', 'Spinal X-ray']",UNK,PFIZER\BIONTECH, 1033203,OH,51.0,F,"Initially felt fine. Got lightheaded, nauseous, dizzy. Brain felt foggy. Wanted to lie down but kept her upright. Doesn't recall ride to emergency department. Next recalls her husband in ER and physician pushing on her chest (sternal rub). Extreme exhaustion",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/10/2021,02/10/2021,0.0,PUB,Humulog - sliding scale Trulisity weekly Glyburide 10 mg daily Albuterol as needed Nebulizer as needed Levothyroxine daily Emprazaprole daily Carafate tablets as needed Lyrica Muscle relaxer (4 hip replacements) Cyclobenzaprine at night Nor,None,Diabetes Asthma Hypothyroidism,,Codeine No food allergies,"['Blood test', 'Chest discomfort', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Nausea', 'SARS-CoV-2 test negative']",1,MODERNA,IM 1033210,NE,20.0,F,"AFter the injection of the second dose, patient complained of headache, heavy feeling, and hypotensive. Was sent to treatment room for fluids. Then presented to ER with same symptoms at 3 AM. Admitted to observation for telemetry and hydration.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/19/2021,01/19/2021,0.0,UNK,,,,,,"['Discomfort', 'Headache', 'Hypotension']",2,MODERNA,IM 1033218,MN,91.0,F,"patient presented to ED with weakness, altered mental status. Admitted to the hospital with urosepsis, acute on chronic kidney injury, elevated lactate and BNP",Not Reported,,Not Reported,Yes,16.0,Not Reported,Y,01/28/2021,01/31/2021,3.0,PVT,"WARFARIN, ASPIRIN, CALCIUM, HCTZ, LIPITOR, METOPROLOL, MIRTAZAPINE, MULTIVTAMIN, NITRO, PEPCID, POTASSIUM, PRESERVISION, PROLIA, TIMOLOL, TYLENOL, XALATAN,",NONE NOTED,"HTN, HLD, DEPRESSION, OSTEOPOROSIS, GLAUCOMA, FACTOR V DEFICIENCY, ANXIETY, CAD, CVD, RENAL INSUFFICIENCY",,PCN,"['Acute kidney injury', 'Asthenia', 'Blood culture', 'Blood gases', 'Blood lactic acid increased', 'Brain natriuretic peptide increased', 'C-reactive protein', 'Chest X-ray', 'Computerised tomogram head', 'Full blood count', 'International normalised ratio', 'Mental status changes', 'Metabolic function test', 'Troponin', 'Urine analysis', 'Urosepsis']",1,PFIZER\BIONTECH,IM 1033236,MN,69.0,M,"patient presented to ED with weakness, dehydration and fall, fever, UTI. Put into observation for IV antibiotics and fluids.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/11/2021,02/13/2021,2.0,PVT,"TYLENOL, ATORVASTATIN, FERROUS SULFATE, JARDIANCE, LACTULOSE, LASIX, LEVEMIR, LEVOTHYROXINE, LEXAPRO, OMEPRAZOLE, VITAMIN A, VITAMIN D, XIFAXAN, ZINC",NONE NOTED,"OSTEOARTHRITIS, DIABETES, HTN, CAD, ANXIETY, DEPRESSION, HLD, FACIAL NERVE PALSY, NEUROPATHY, ASCITES, HEPATIC ENCEPHALOPATHY, LYMPHOMA, CIRRHOSIS, HYPOTHYROIDISM, DEHYDRATION, WEAKNESS",,CITALOPRAM,"['Asthenia', 'Culture urine', 'Dehydration', 'Fall', 'Full blood count', 'Metabolic function test', 'Procalcitonin', 'Pyrexia', 'Urinary tract infection', 'Urine analysis']",1,MODERNA,IM 1033263,,69.0,F,patient passed away within 60 days of receiving COVID vaccine,Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,,01/27/2021,02/14/2021,18.0,PVT,,,,,,['Death'],1,MODERNA, 1033268,ND,87.0,F,"Patient presents to our emergency department on 2/13/2021 with complaints of nausea, vomiting & diarrhea, dehydration and headache. Iv fluids administered, patient kept observation for 24+ hours.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/11/2021,02/13/2021,2.0,PVT,,Unknown,"diabetes, hypertension, GERD, Hyperlipidemia",,Iodinated Contrast Media;,"['Blood creatine increased', 'Blood lactic acid', 'Blood lactic acid decreased', 'Blood magnesium normal', 'Blood potassium decreased', 'Dehydration', 'Diarrhoea', 'Headache', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 1033286,PA,49.0,M,Patient stated she felt like her throat was closing and started sounding hoarse. Doctor examined patient and took her vitals which was stable. Patient was given a Benadryl and then sat for a couple of minutes. Patient then stated she had difficulty breathing and was given a Epi Pen and 911 was called for a Ambulance. Took patients vitals before Ambulance arrive and it was still stable. Ambulance arrived and patient was taken to the hospital.,Not Reported,,Not Reported,Yes,,Not Reported,Y,02/11/2021,02/11/2021,0.0,PUB,,No,"Bi Polar Disorder, Migraines, Chronic Pain Syndrome",,"Chlorthalidone, Penicillin","['Dysphonia', 'Dyspnoea', 'Throat tightness']",1,MODERNA,IM 1033297,IL,71.0,M,"Pt had fever to 102, headache, weakness and needed help out of bed, fell once and even had some confusion. He had to be watched overnight in the hospital 2/11-2/12. By 48 hours after the vaccine, he felt improved and normal by 72 hours. Note that pt had similar but not as severe reaction the first vaccine(Pfizer EL9882) that I was not aware of til now. Also note that pt had covid infection about 3 months prior to this vaccine.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/11/2021,02/12/2021,1.0,PUB,"aspirin, atenolol, atorvastatin, finasteride, hctz, lantus, jardiance, lisinopril, metformin, omeprazole, terazosin",no acute illness. pt is diabetic and has htn and hyperchol as well as gerd and bph,see above,,amlodipine,"['Asthenia', 'Computerised tomogram head', 'Confusional state', 'Fall', 'Headache', 'Laboratory test normal', 'Mobility decreased', 'Pyrexia', 'White blood cell count']",2,PFIZER\BIONTECH,IM 1033307,FL,84.0,M,"Following morning a sore throat leading two days later an inability to swallow, constant mucus production, several boxes of tissues dsily; hospitalized for 4 days on intravenous fluids and anti biotics.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/27/2021,01/28/2021,1.0,MIL,"Pravastatin, Nifedipine, Omeprazole, Sertraline, Doxazosin Mesylate, Furosemide, Latanoprost, Tartrate",,"Asthma, High Blood Pressure, Back problems,",,Eliquis not tolerated,"['Dysphagia', 'Oropharyngeal pain', 'Rhinorrhoea']",UNK,MODERNA, 1033323,,61.0,M,patient passed away within 60 days of receiving a COVID vaccine,Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,,01/14/2021,02/13/2021,30.0,UNK,,,,,,['Death'],1,PFIZER\BIONTECH, 1033327,TX,,M,"I received first dose of Pfizer COVID vaccine on 12/22/2020. On 1/9/2021, I have started to have palpitations, chest tightness, shortness of breath and Dizziness. On 1/12/2021, I received the second dose of Pfizer COVID vaccine. On 1/12/2021, I visited an urgent care for these symptoms where they did EKG which Premature Ventricular contractions and rapid COVID test nasal swab was negative. On 1/13/2021, my symptoms got worse and went to the hospital where have been admitted for observation for telemetry. Telemetry showed premature ventricular contractions. I had nuclear stress test on 1/14/2021 which did not show ischemia. I had CT chest which was normal. I had repeat COVID nasal swab PCR which was negative. During that hospital stay, I was diagnosed with premature ventricular contractions and Postural Orthostatic tachycardia syndrome. I was discharged from the hospital on 1/14/2021 on Diltiazem. I felt temporary improvement in my palpitations. I had a 24 hours holter cardiac monitor on 1/22/2021 which shows PVCs. I have been seen by electrophysiologist after the hospital discharge who prescribed me Fludrocotrisone for the postural Orthostatic tachycardia syndrome in addition to the Diltiazem for the PVCs. On 2/5/2021, my symptoms happened again with the same severity when it started on 1/9/2021 despite been very compliant with the prescribed medications. I will have follow up with electrophysiologist to discuss the treatment plan including the option for electrophysiology study and possible ablation. I have not been diagnosed with any heart disease in the past. I believe these heart problems happened as side effects to the Pfizer COVID vaccine.",Not Reported,,Yes,Yes,,Yes,,12/22/2020,01/09/2021,18.0,UNK,"Metformin, Diltiazem, Fludrocortisone, Aspirin and Atorvastatin; Multivitamins",None,"Prediabetes, newly diagnosed with premature ventricular contractions and Postural Orthostatic tachycardia syndrome on 1/13/2021",,None,"['Cardiac stress test normal', 'Cardiac telemetry abnormal', 'Chest discomfort', 'Computerised tomogram thorax normal', 'Condition aggravated', 'Dizziness', 'Dyspnoea', 'Electrocardiogram abnormal', 'Electrocardiogram ambulatory', 'Electrocardiogram ambulatory abnormal', 'Inappropriate schedule of product administration', 'Palpitations', 'Postural orthostatic tachycardia syndrome', 'SARS-CoV-2 test negative', 'Ventricular extrasystoles']",UNK,PFIZER\BIONTECH, 1033340,CA,31.0,F,Vaccine was administered at 10:35 am to right deltoid IM. At 10:45am patient began to experience slurred speech and reported tongue swelling. Benadryl 50 mg was administered IM. Patient began to cough reporting nausea and was given Epi Pen 0.3 mg IM. No objective swelling noted to tongue. Patient was feeling better after Epi pen administration . Employee refused 911.,Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/21/2021,01/21/2021,0.0,PVT,Aygestin 5mg BID,none,Asthma,,All Nuts - anaphylaxis Shellfish - anaphylaxis Cinnamon - anaphylaxis Tylenol - anaphylaxis Imitrex- anaphylaxis Mango - rash Pineapple - rash/swelling Oranges - hives,"['Cough', 'Dysarthria', 'Nausea', 'Swollen tongue']",1,MODERNA,IM 1033364,LA,78.0,M,"Pt received vaccine on 1 Feb and presented to the ED on 3 Feb with Abdominal pain, epigastric; Acute pancreatitis without infection or necrosis, unspecified pancreatitis type; Hypertension, unspecified type; SOB (shortness of breath). He was discharged on 6 Feb 2021",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/01/2021,02/03/2021,2.0,PVT,,,Hypertension,,ACE INHIBITORS; BENAZEPRIL; LEVOFLOXACIN,"['Abdominal pain', 'Abdominal pain upper', 'Dyspnoea', 'Hypertension', 'Pancreatitis acute']",2,PFIZER\BIONTECH,IM 1033372,MI,79.0,M,"REPORT GIVEN BY HIS WIFE. DAY ONE: ITCHING IN ODD AREAS OF BODY (UNDER ARMS AND BACKSIDE). NEXT DAY FEELING TIRED. FRIDAY HE DID FEEL WELL AND O2 LEVEL 91% - 88% THEN A RASH WAS NOTED FROM NECK DOWN TO LEGS. WIFE TOOK HIM TO THE HOSPITAL SATURDAY MORNING. IN ER FOR ALLERGICE REACTION, BUT THEN TOOK A TURN FOR THE WORSE AND WAS PLACED ON BI PAP MACHINE FOR ABOUT 5 HOURS. DISCHARGED AFTER 5 DAYS IN HOSPITAL. ALLERGIST CALLED I N TO CONSULT-",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/28/2021,02/02/2021,5.0,PUB,"2 INHALORS, BLOOD PRESSURE MEDICATION",DENIES,LUNG CA - RT UPPER LUNG REMOVED AND HTN,,KNA,"['Bilevel positive airway pressure', 'Fatigue', 'Hypersensitivity', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 1033381,OH,72.0,F,"On the evening of 2/3/21, patient did not feel well. On 2/4/21, the patient became more unsteady than usual and felt weak. By the evening of 2/4/21, the patient went to the restroom and could not get off the toilet. every time she tried to stand up, her legs buckled underneath her. Her caretakers called the squad and she was admitted to the hospital with possible transverse myelitis.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/03/2021,02/03/2021,0.0,PUB,"metoprolol tartrate, acetaminophen, albuterol, atorvastatin, b complex vitamins, budesonide, calcium + D3, donepezil, esomeprazole, ferrous sulfate, fluticasone, folic acid, guaifenesin, levothyroxine, losartan, multi-vitamin, olanzapine, s",None,"Anemia, arthritis, asthma, Barrett esophagus, Depression, Cancer (HCC), GERD, hyperlipidemia, hypertension, hypothyroidism, mental disability (mild MR), osteoarthritis, renal artery stenosis, stomach ulcers, urinary frequency",,"Phenelzine sulfate, terfenadine, amoxicillin","['Asthenia', 'Balance disorder', 'Dysstasia', 'Malaise']",2,MODERNA,IM 1033396,ME,84.0,M,Admitted to Medical Center with syncopal event that occurred at home. Cause of syncope unclear at discharge,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/27/2021,01/31/2021,4.0,PVT,"Lisinopril, betamethasone cream, fluoxetine, sublingual nitroglycerin as needed, rosuvastatin, triamcinolone cream, glucosamine, vitamin c, aspirin, b complex vitamin, folic acid, multivitamin, fish oil",Right sided low back pain Cough for months,"Coronary artery disease, Hyperlipidemia, HTN, Carotid stenosis, Impaired fasting glucose, depression, Alzheimers, subdural hematoma",,"Meloxicam, penicillin","['Angiogram', 'Blood magnesium', 'Brain natriuretic peptide', 'Echocardiogram', 'Electrocardiogram', 'Fibrin D dimer', 'Full blood count', 'Glycosylated haemoglobin', 'Lipids', 'Metabolic function test', 'SARS-CoV-2 test', 'Syncope', 'Troponin']",UNK,PFIZER\BIONTECH,IM 1033412,OH,35.0,F,"20 weeks gestation at time of vaccine administration. Saw OB that morning (1/12/21), normal exam and fetal heart rate. Normal anatomy scan 1/8/21, normal genetic screening. Fetal demise noted at 24 week OB visit on 2/9/21, stillborn baby delivered 2/12/21.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/12/2021,02/09/2021,28.0,PUB,"Montelukast, loratidine, prenatal vitamin, magnesium supplement, 81mg aspirin",20 weeks pregnant at time of vaccine 1/12/21; intrauterine fetal demise noted at regular OB visit 2/9/21,"Asthma, migraines",,No known allergies,"['Autopsy', 'Exposure during pregnancy', 'Foetal death', 'Foetal heart rate normal', 'Stillbirth']",1,MODERNA,IM 1033426,CA,65.0,F,"Stroke with right upper extremity weakness. Weakness improved, has mild residual weakness at this time. That still may improve in the coming months.",Not Reported,,Not Reported,Yes,2.0,Yes,N,01/21/2021,01/24/2021,3.0,PVT,"? Ergocalciferol, Vit D2, (DRISDOL) 1,250 mcg (50,000 unit) Oral Cap Take 1 capsule by mouth every week ? Mometasone (ELOCON) 0.1 % Top Crea Apply to affected area(s) 2 times a day as needed for rash (face and neck) ? Clobetasol (TEMOVATE)",New diagnosis of dermatomyositis sine myositis HTN prior Bell's palsy 2016,as above,,Iodine,"['Cerebrovascular accident', 'Magnetic resonance imaging brain abnormal', 'Muscular weakness']",1,MODERNA,IM 1033435,WA,72.0,M,Patient noted to have bilateral upper extremity weakness on 2/15/21 (received first dose of covid vaccine on 1/29/21) requiring hospitalization. As of today 2/16. On MRI found to have central cord syndrome of cervical spine - Working up for transverse myelitis vs thromembolic central cord ischemic event. Care team interested in guidance about if second dose of vaccine would be appropriate at this time (due for second dose of vaccine 2/19),Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/29/2021,02/15/2021,17.0,PVT,allopurinol Flomax hydrochlorothiazide lisinopril,Likely had Covid in December 2020 (wife tested positive 12/10/2020 and patient had anosmia),BPH Gout HTN,,,"['Central cord syndrome', 'Magnetic resonance imaging neck', 'Muscular weakness', 'Spinal cord injury cervical']",1,PFIZER\BIONTECH,UN 1033444,CA,80.0,M,symptoms of ongoing congestive heart disease just progressed,Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,,01/16/2021,01/25/2021,9.0,PVT,congestive heart disease medications,"Addison's disease, abdominal hernia",Congestive heart disease Addison's disease,,sulfa,"['Cardiac failure congestive', 'Condition aggravated']",UNK,PFIZER\BIONTECH,UN 1033447,AR,39.0,F,"1/21/21 pt started experiencing fever about 3:30 PM, went to Urgent care received rapid COVID test which was negative, 1/22/21 still has fever drive thru at hospital covid drive thru pt had PCR and it was also negative, went back to same drive thru on 1/24/21 and had another PCR which was negative, 1/25/21 urgent care visit, pt was tested for flu-Negative, lab work was done which showed CBC all counts were low resulted in ER visit, admitted 1/25/21 afternoon with panside apnea and sepsis and patient stayed in hospital for 9 days 2/2/21 pt was released to go home. Lots of labs and test were done while patient was inpatient, Pt is still weak and has no energy.",Not Reported,,Not Reported,Yes,9.0,Not Reported,N,12/31/2020,01/21/2021,21.0,PHM,"Gabapentin, Keppra, Plaquenil, Imuran, Protonic, Vitamin D every other week, Flexural as needed, Lunesta as needed, Buspar, Remeron, Multivitamins",,"Seizure Disorder, Systemic Lupus",,Ultram,"['Apnoea', 'Asthenia', 'Full blood count abnormal', 'Influenza virus test negative', 'Laboratory test abnormal', 'Pyrexia', 'SARS-CoV-2 test negative', 'Sepsis']",1,PFIZER\BIONTECH,IM 1033448,MN,82.0,F,"Fever by the next day, difficulty breathing, pneumonia, and then DEATH within a few days. (Died 02/01/2021)",Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,SEN,Blood Thinners Pyschotropics,Had Covid-19 one month prior,Irregular Heart Asthma pneumonia prone,,,"['Death', 'Dyspnoea', 'Pneumonia', 'Pyrexia']",UNK,MODERNA, 1033465,,68.0,F,"68-year-old female evaluated for painful movement of her extremities. Patient reports that her symptoms started the day after receiving the Pfizer COVID-19 vaccine at pharmacy. Patient was admitted. Patient has been evaluated by Neurology, Rheumatology and the Ortho-Spine Service. Symptoms improved with prednisone. Although unclear, a diagnosis of polymyalgia rheumatica was being considered due to elevated CRP (inflammatory marker). Relationship to vaccine administration is also unclear. Pt with Hx of arthritis, COPD, CAD, CHF, and HTN received first dose of Pfizer COVID-19 Vaccine. Within 24 hours of vaccine administration, pt went to hospital c/o of painful movement of extremities. Pt was treated with prednisone and symptoms improved. She was evaluated by multiple specialties including neurology, rheumatology and orthopedics without a clear diagnosis. Her CRP was elevated to 17.2 mg/dL and Sed Rate to greater than 130 mm/hr and reactive ANA titer. Total CK was normal at 23 IU/L. Rheumatology wrote this is highly suggestive of COVID-19 vaccine induced polymyalgia rheumatica which has been reported with other vaccines but not with COVID-19 vaccines.",Not Reported,,Not Reported,Yes,,Not Reported,,,,,UNK,,,Asthma/COPD; Coronary artery disease; Hypertension; CHF,,,"['Antinuclear antibody positive', 'Blood creatine phosphokinase normal', 'C-reactive protein increased', 'Pain', 'Pain in extremity', 'Polymyalgia rheumatica', 'Red blood cell sedimentation rate increased']",1,PFIZER\BIONTECH,IM 1033466,,70.0,M,"70 yo man with multiple severe medical comorbidities received his first dose of Moderna COVID-19 vaccination without incident. 8.5 hours later, he was noted by his family to be in his usual state of health. 9.5 hours after the vaccination, he was found down by his family in cardiac arrest. Resuscitation attempts were not successful, and the patient died.",Yes,,Not Reported,Not Reported,,Not Reported,,,,,UNK,,,"Asthma/COPD, Diabetes mellitus (DM), Hypertension (HTN), Renal Disease (e.g. CKD, HD, ESRF), A-fib, pulmonary hypertension, chronic loculated empsyema, chronic aspiration pneumonitis, pacemaker, chronic anticoagulation",,,"['Cardiac arrest', 'Death', 'Resuscitation']",1,MODERNA,IM 1033472,,,U,"Resident coded and expired; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and coded and expired. The patient's medical history was not provided. No concomitant product use was reported. On an undisclosed date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection. On undisclosed date, the patient coded and expired. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on an undisclosed date. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: MEDICAL COMMENT: MOD 2021 009822 DEATH NOS This case concerns a patient of unknown age and gender who received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection and had died. Very limited information regarding this event has been provided at this time to make a proper medical assessment, therefore, the causality is unlikely related to the vaccine in this case of death not otherwise specified. No contact information provided. Follow up is not expected.; Reported Cause(s) of Death: Unknown cause of death",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Death'],1,MODERNA,OT 1033473,CO,79.0,F,"Blacked out; fell down the stairs; concussion; damaged or severed 6th cranial nerve to right eye; brain bleed; split lip; A spontaneous report was received from a consumer concerning a 79-years-old, female patient who received Moderna's COVID-19 Vaccine, and who blacked out, fell down the stairs, brain bleed, concussion, damaged or severed 6th cranial nerve to right eye and split lip. The patient's medical history included diabetes, two unspecified high blood pressure medications and naproxen sodium. Products known to have been used by the patient, within two weeks prior to the event, included Sitagliptin and blood pressure medication. On 21 Jan 2021, approximately one and half hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 027L20A) intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient ""blacked out"" while walking downstairs after one in and half hours of receiving vaccination. Patient was hospitalized from 21 Jan 2021 until 22 Jan 2021. Patient has a brain bleed and a concussion, damaged 6th cranial nerve to right eye, and split her lip which need stitches. Treatment for the event included Tylenol as needed. Action taken with mRNA-1273 in response to the events was withdrawn. The events blacked out and fell down the stairs was resolved on 21 Jan 2021. The outcome of the events brain bleed, concussion, damaged or severed 6th cranial nerve to right eye and split lip was unknown.; Reporter's Comments: This case concerns a 79 year old female patient with medical history of diabetes, two unspecified high blood pressure medications and naproxen sodium, who experienced serious unexpected events of fall, cerebral hemorrhage, loss of consciousness, concussion, damaged or severed 6th cranial nerve to right eye and split lip. The event occurred approximately one and half hours after first dose of the study medication administration. Treatment included Tylenol as needed. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Noting the subject's underlying medical condition could remain a confounder.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/21/2021,01/21/2021,0.0,UNK,JANUVIA [SITAGLIPTIN]; ALEVE; Blood pressure medication,Diabetes; Hypertension,,,,"['Cerebral haemorrhage', 'Concussion', 'Cranial nerve injury', 'Fall', 'Lip injury', 'Loss of consciousness']",1,MODERNA,OT 1033474,NC,36.0,M,"About a week later developed MRSA; A spontaneous report was received from a pharmacist concerning a 36-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and about a week later developed MRSA (Methicillin-resistant Staphylococcus aureus). The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date, about a week after vaccine administration, the patient developed MRSA. No further information was provided regarding the patient. No treatment information was provided. Action taken with RNA-1273 in response to the event was unknown. The outcome of the event, about a week later developed MRSA, was unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Staphylococcal infection'],1,MODERNA,OT 1033475,DC,,M,"delayed reaction; WBC in blood; felt tired; diagnosed with Urinary tract infection; blood in urine; soreness in the arm lasted 24 hours; A regulatory authority report was received from a consumer regarding himself, a patient who is a 68-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness in the arm that lasted 24 hours, diagnosed with a urinary tract infection, blood in the urine, WBC in the blood, felt tired as a delayed response to the vaccine. The patient's medical history was not explicitly provided, however the patient noted that he takes ""blood pressure medication"" and ""Benign Prostatic Hypertrophy medication."" On 12 Jan 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the same day, patient stated that he had soreness in the arm that lasted 24 hours. No treatment information was reported and event is considered recovered/resolved. On 13 Jan 2021, after the mRNA-1273 vaccine was given, the patient was reported to have been diagnosed with a urinary tract infection and had blood in his urine. On 15 January 2021, the patient reported that there were white blood cells in his urine and felt tired. He was questioning if this is a delayed reaction to the vaccine. Treatment information included antibiotic for the urinary tract infection. Action taken with mRNA-1273 was not reported. The outcome of the events, soreness in arm for 24 hours is considered resolved as of 12 Jan 2021. The outcome of the events, urinary tract infection, blood in urine, white blood cells in urine, and feeling tired were not reported.; Reporter's Comments: The events of urinary tract infection, blood in the urine, WBC in the blood is more likely associated with the patient's suspected underlying condition of benign prostatic hypertrophy Hence assessed as unlikely related to mRNA-1273. Fatigue and muscle soreness are temporarily associated with mRNA-1273 use and consistent with the known safety profile of the vaccine. Thus, causal association cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Benign prostatic hypertrophy,,,"['Blood urine present', 'Fatigue', 'Myalgia', 'Therapeutic response delayed', 'Urinary tract infection', 'White blood cell count']",1,MODERNA,OT 1033484,OR,62.0,F,"Anaphylaxis. Used epiPen, taken to ER. Given solumedrol 125 mg, bendadryl, 25 mg IV monitored 4hours. Sent home with solumedrol dose packet and new epipen",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,PVT,"Levothyroxine, zafirlukast, Trintellix, clonazepam, Allegra, vitamin d, multiple vitamin,",None,"Thyroid disease, asthma, depression, myoclonus, traumatic brain injury",,"Rocephin, morphine, X-ray dye, iron sucrose, tree nuts, peanuts, bee stings","['Anaphylactic reaction', 'Electrocardiogram abnormal']",1,MODERNA,IM 1033490,SC,78.0,F,"The patient was administered the Moderna Covid-19 vaccine on 1/14/2021. The patient reported experiencing arm pain around the injection site during the 2 days following the vaccination. The patient reported experiencing hip pain and trouble with her legs on 1/21/2021. On 1/22/2021 the patient reported not being able to stand without bracing. The patient visited a doctor on 1/25/2021 and there was suspicion for inflammation of the spinal cord leading to the patient being prescribed prednisone for 6 days. The patient visited the doctor again on 2/2/21 and another course of prednisone was initiated. The patient reports that she can stand from a sitting position without help getting up about half the time and that she had no such trouble standing prior to the vaccination. The patient returned to the second vaccination clinic on 2/11/2021, which was 4 weeks after receiving the first dose, to report her symptoms. The patient was not administered the second dose of the Moderna Covid-19 vaccine.",Not Reported,,Not Reported,Not Reported,,Yes,U,01/14/2021,01/21/2021,7.0,SEN,,,,,,"['Arthralgia', 'Dysstasia', 'Incomplete course of vaccination', 'Injection site pain']",1,MODERNA,IM 1033510,FL,56.0,M,"1/26/2021: Fatigue, Soreness & headache; Severe chills (0120 a.m.); Body aches, joint pain, nausea/vomiting, pale/cool/diaphoretic skin, chest tightness and lightheaded/Dizziness. Bed rest for remainder of day. 1/27/2021: Continued fatigue, soreness, more lightheaded/dizziness, onset of sustained Ventricular Tachycardia around 1400 hours,Tx at work with Advanced Cardiac Life Support, Emergency Transport to Emergency Room, Amiodarone Drip/Oxygen/IV-TKO,EKG. Emergency Room-Continue Cardiac Care with continued IV drip and Amiodarone. Echo-Cardiogram and admit to Hospital. 1/28/2021: Cont. Hospitalization-Cardiac Cath,monitoring on ICC floor. Hospitalization stay 1/27/2021-02/03/2021. Transfer to another hosp by ambulance. Transferred to Hospital (1/30/21). Further treatment and monitoring. Cardiology tests and procedures (Cardiac MRI, Electro-Physiological Study and defibrillator insertion). Discharged on 2/3/2021. Still under doctor's care during recovery for next 5 weeks and ongoing into the future.",Not Reported,,Yes,Yes,7.0,Yes,N,01/25/2021,01/26/2021,1.0,OTH,"Adult Multi-Vitamin, D-3, C, B-Complex, Zinc, Magnesium, Tumer",None,None,,None,"['Arthralgia', 'Blood magnesium decreased', 'Blood potassium decreased', 'Cardiac electrophysiologic study', 'Catheterisation cardiac normal', 'Chest discomfort', 'Chills', 'Dizziness', 'Echocardiogram normal', 'Electrocardiogram abnormal', 'Fatigue', 'Feeling cold', 'Headache', 'Hyperhidrosis', 'Implantable defibrillator insertion', 'Intensive care', 'Magnetic resonance imaging heart', 'Myocardial necrosis marker normal', 'Nausea', 'Pain', 'Pallor', 'Ventricular tachycardia', 'Vomiting', 'White blood cell count abnormal']",2,MODERNA,IM 1033516,MN,32.0,F,"At the time of administration of the first does of Moderna vaccine, I was 6 weeks pregnant. I had confirmed pregnancy with home positive test and missed period. I had an estimated due date of 9/24/2021. This was my 4th pregnancy. I have had two uncomplicated pregnancies to term. In September 2020 experienced a chemical pregnancy with early pregnancy loss at 5 weeks. The first 24 hours after 1st dose of vaccine I experienced extreme arm soreness in the arm that was vaccinated, causing headache and unable to sleep. After 24 hours I felt ""normal"". 2 weeks and 3 days following the first dose of Moderna, I had a miscarriage. On the night of 2/15/21 I lost the pregnancy with vaginal bleeding, bright red blood, passing tissue, clots/ sac. I had an uneventful pregnancy up to that point, feeling well as I had with prior pregnancies.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,02/15/2021,17.0,PUB,"prenatal multivitamin, iron supplement","On 1/20/2021 tested for Covid-19 via nasal swab due to having sore throat, fatigue, and headache. Test results came back negative that same day.","No chronic health issues, otherwise very healthy.",,NKA,"['Abortion spontaneous', 'Exposure during pregnancy', 'Headache', 'Pain in extremity', 'Sleep disorder', 'Ultrasound abdomen abnormal', 'Ultrasound scan vagina abnormal']",1,MODERNA,IM 1033542,IL,58.0,F,I experienced and embolic Stroke that is currently not determined a cause for at this time,Not Reported,,Yes,Yes,3.0,Not Reported,N,01/08/2021,02/05/2021,28.0,PVT,"Zyrtec, Estridial, XHance and Melatonin",none,migraines,,"penicillin, sulfa Depakote and latex","['Angiogram cerebral', 'Arteriogram carotid', 'Computerised tomogram head', 'Echocardiogram', 'Embolic stroke', 'Implantable cardiac monitor insertion', 'Intensive care', 'Magnetic resonance imaging brain']",UNK,PFIZER\BIONTECH,IM 1033560,MT,80.0,M,bilateral unprovoked Pulmonary emboli,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/10/2021,02/14/2021,4.0,UNK,co enzyme q 10 coscopt Diflucan xalatan omega oil simvastatin vitamin c vitamin d,none,BPH,,none,"['Computerised tomogram thorax', 'Pulmonary embolism']",UNK,PFIZER\BIONTECH, 1033563,NJ,70.0,F,"Initial pain in Shoulders and Neck (Bilateral) Descending Peripheral Bilateral Neuropathy in legs and Feet on Wednesday , Followed by Ataxia Tremors in 5 th digit of both hands , Itching on both wrists up to elbows bilaterally Numbness appears to have resolved. Numbness persists on left abdomen from waist to underarm. Thursday and then Friday then stronger in legs . Saturday weaker in legs , lack of balance with some word retrieval relative to previous days.",Not Reported,,Not Reported,Yes,5.0,Yes,N,01/28/2021,02/09/2021,12.0,PVT,Linsinopril Paroxetine amlodipine rosuvastatin,none,11 years post Breast Ca diagnosis and successful treatment,,none,"['Aphasia', 'Arthralgia', 'Ataxia', 'Balance disorder', 'Blood test', 'Computerised tomogram neck', 'Hypoaesthesia', 'Immunodeficiency', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging spinal', 'Muscular weakness', 'Myelitis transverse', 'Neck pain', 'Neuropathy peripheral', 'Pruritus', 'Scan with contrast', 'Tremor']",1,MODERNA,ID 1033570,CO,96.0,M,"PT REPORTED TO EMERGENCY DEPARTMENT WITH COMPLAINTS OF WEAKNESS AND FALL 2/15/21. PATIENT STATES THAT HE HAS BEEN FEELING WEAK AND TODAY IT SEEMS WORSE. HE REPORTS ATTEMPTING TO AMBULATE WHEN HIS LEGS GAVE OUT. HE STATES THAT HE DID NOT TRULY FALL BUT WAS ABLE TO LOWER HIMSELF TO THE GROUND. HE WAS UNABLE TO GET UP AND THEREFORE CALLED EMS. EMS WERE ABLE TO HELP PATIENT UP AND AMBULATING. EMS NOTED URINARY BAG HAD GROSS HEMATURIA. PT REPORTS BLOODY URINARY OUTPUT THE PREVIOUS NIGHT. PATIENT COMPLAINS OF PENILE PAIN. NO RECENT ILLNESS INCLUDING FEVERS, URI SYMPTOMS, VOMITING OR DIARRHEA. ASSESSMENT UPON ADMIT: *CONTINUATION SEE BELOW PT REPORTED TO EMERGENCY DEPARTMENT WITH COMPLAINTS OF WEAKNESS AND FALL 2/15/21. PATIENT STATES THAT HE HAS BEEN FEELING WEAK AND TODAY IT SEEMS WORSE. HE REPORTS ATTEMPTING TO AMBULATE WHEN HIS LEGS GAVE OUT. HE STATES THAT HE DID NOT TRULY FALL BUT WAS ABLE TO LOWER HIMSELF TO THE GROUND. HE WAS UNABLE TO GET UP AND THEREFORE CALLED EMS. EMS WERE ABLE TO HELP PATIENT UP AND AMBULATING. EMS NOTED URINARY BAG HAD GROSS HEMATURIA. PT REPORTS BLOODY URINARY OUTPUT THE PREVIOUS NIGHT. PATIENT COMPLAINS OF PENILE PAIN. NO RECENT ILLNESS INCLUDING FEVERS, URI SYMPTOMS, VOMITING OR DIARRHEA. ASSESSMENT UPON ADMIT: THROMBOCYTOPENIA (PRESUMED ITP, CAUSE? VACCINE?), DEXAMETHASONE 20MG PO DAILY. AMINOCAPROIC ACID 5GM IVPB X1 DOSE, 1 UNIT FFP, 2 UNITS PLTS PHERESED",Not Reported,,Yes,Yes,,Not Reported,N,02/07/2021,02/15/2021,8.0,PVT,"TAMSULOSIN 0.8MG DAILY, FINASTERIDE 5MG DAILY, OMEPRAZOLE 20MG DAILY, FUROSEMIDE 40MG DAILY, POTASSIUM CHLORIDE 10mEQ DAILY, LIDOCAINE 4% PATCH DAILY PRN, HYDROCODONE-ACETAMINOPHEN 5/325, ONE Q6H PRN, GABAPENTIN 600MG BID, APIXABAN 5MG BID,",,"CHF, CKD, h/o PE/DVT, URINARY RETENTION",,"CARBAMAZEPINE = sob, fever, weakness in legs AMOXICILLIN = body rash BACTRIM [SULFAMETHOXAZOLE-TRIMETHOPRIM] = weakness and falls, altered mental status","['Asthenia', 'Basophil count normal', 'Basophil percentage', 'Dysstasia', 'Eosinophil count normal', 'Eosinophil percentage', 'Fall', 'Gait disturbance', 'Granulocyte count', 'Granulocyte percentage', 'Haematocrit normal', 'Haematuria', 'Haemoglobin decreased', 'Lymphocyte count normal', 'Lymphocyte percentage', 'Mean cell haemoglobin concentration decreased', 'Mean cell haemoglobin normal', 'Mean platelet volume', 'Monocyte count normal', 'Monocyte percentage', 'Muscular weakness', 'Neutrophil count', 'Neutrophil percentage', 'Penile pain', 'Platelet aggregation decreased', 'Platelet count decreased', 'Platelet transfusion', 'Red blood cell count decreased', 'Red cell distribution width normal', 'Thrombocytopenia', 'Transfusion', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 1033573,MI,102.0,M,"Patient is 102 years old history of hypertension hypothyroidism, patient presenting with altered mental status, hemoglobin of 4.6 with creatinine of 2.53, patient has lactic acidosis, anion gap metabolic acidosis. Stool Hemoccult is positive, platelet count of 23,000 noted. Patient is awake but confused, patient's son is by the bedside.Patient has diffuse oozing from multiple skin wounds,Patient has received 2 units of blood along with 2 units of platelets and 2 units of FFP. Fibrinogin of 209. Hematology service recommended starting dexamethasone for suspected ITP. Patient is a PMH of �spontaneous subdural >�20 years ago, surgically evacuated, HTN, Hypothyroidism ,pre-diabetes who presented to the ED with CC of AMS and slurred speech x 1 day. History obtained from son at bedside and chart review. At baseline patient is reportedly very independent and able to ambulate in the home without assistive devices. He handles his own ADLs. Patient reportedly received his 2nd dose of the COVID vaccine on Monday and since then has been experiencing fatigue and generalized weakness, in addition to decreased appetite. AMS started yesterday. He reportedly fell out of bed last night around 2 AM and family found him at 7 AM on the floor. Denied loss of consciousness. He was evaluated by Stroke team, CT of the head was un-revealing for an acute process and stable chronic changes, and CTA revealed some mild intracranial stenoses, Stroke team felt was unlikely to be an acute stroke. He was found to have Hb 4.6 on admission. Platelets were 23, He was transfused 1 unit of blood and 1 unit of platelets. Hematology was consulted and recommended dexamethasone 20 mg daily for 3 days. Rectal exam was done and he was found to be Guaiac positive was started on Protonix 40 BID.",Not Reported,,Yes,Yes,4.0,Not Reported,Y,02/08/2021,02/08/2021,0.0,PVT,Unknown,Nothing new,"Hypothyroidism, hyperlipidemia, type II diabetes, irregular heart beat, chronic cough, chronic kidney disease, arthritis, pacemaker",,None,"['Angiogram', 'Anion gap', 'Asthenia', 'Blood creatinine increased', 'Blood fibrinogen', 'Cerebral artery stenosis', 'Confusional state', 'Decreased appetite', 'Dysarthria', 'Fall', 'Fatigue', 'Haemoglobin decreased', 'Occult blood positive', 'Platelet count decreased', 'Platelet transfusion', 'Rectal examination abnormal', 'Skin wound', 'Transfusion']",2,PFIZER\BIONTECH,IM 1033581,GA,45.0,F,"At 15 hours after vaccine- I became nauseated and vomited repeatedly. Several hours later, I was still nauseated and unable to hold anything down and my torso and stomach was in pain. I dealt with the pain for 2 more days and eventually went to the ER on Sunday 2/6. After a blood test and a CT scan, I was informed that I had an inflammed pancreas (pancreatitis).",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,02/04/2021,02/05/2021,1.0,PUB,fluoxetine 40 mg/daily,No,kidney stones acute reoccuring Pancreatitis migraines,1st moderna covid vaccine,Topomax,"['Abdominal pain upper', 'Blood test abnormal', 'Computerised tomogram abnormal', 'Nausea', 'Pain', 'Pancreatitis', 'Vomiting']",2,MODERNA,SYR 1033584,MN,86.0,F,"Resident experienced chills, fatigue, nausea, coughing, weakness, loss of appetite, and tachychardia on 2/15/21. She was transferred to the ER and admitted to the hospital (attached to nursing home) for NSTEMI and cholelithiasis/cholecystitis.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/14/2021,02/15/2021,1.0,SEN,Aspirin 325 mg; Bumetanide 0.5 mg; Lisinopril 10 mg; Magnesium 250 mg; Metformin HCl 1000 mg; Polyethylene Glycol 3350 17 g; Omeprazole 20 mg; Acetominophen 325 mg; Biofreeze gel 4%; Epsom salt soaks; Sarna lotion 0.5%; Gabapentin 100 mg; A,"Chest x-ray from 2/10/2021 indicates possible mild, patchy bronchopneumonia (on duonebs for this)",Dementia; hemiplegia and hemiparesis following cerebral infarction affecting right dominant side; Type 2 Diabetes; osteoporosis; osteoarthritis; hypokalemia; essential hypertension; gastro-esophageal reflux disease without esophagitis,,None listed in chart,"['Activated partial thromboplastin time prolonged', 'Acute myocardial infarction', 'Asthenia', 'Blood lactic acid', 'Chills', 'Cholecystitis', 'Cholelithiasis', 'Cough', 'Decreased appetite', 'Fatigue', 'Influenza virus test negative', 'Nausea', 'SARS-CoV-2 test negative', 'Tachycardia', 'Troponin I increased']",2,MODERNA,IM 1033585,TX,59.0,M,"The decedent received first Covid vaccine, 12/2020 and second vaccine 01/07/2021. The decedent experienced no known side effects.",Yes,,Not Reported,Not Reported,,Not Reported,,01/07/2021,,,UNK,,,,,,['Death'],2,UNKNOWN MANUFACTURER,UN 1033607,CA,73.0,M,"Vomiting, death.",Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,MIL,"Metformin, anti depressant, baby aspirin.",Allergies,"Diabetes, circulation problems, awaiting stent surgery on neck artery.",,None,"['Death', 'Vomiting']",2,MODERNA, 1033611,CA,68.0,M,"very pruritic maculopapular -purple and red rash diffusely throughout body and extremities and neck. Sores in the mouth and blisters forming on palms of hands and soles of feet with some pain, ureteral meatus erythema and anal erythema. pain with swallowing",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/08/2021,02/09/2021,1.0,PUB,Hydroxyzine,Macular degeneration - injections,"Macular degeneration, T2DM, HTN, GERD, BPH",,Naproxen,"['Anal erythema', 'Biopsy skin', 'Blister', 'Odynophagia', 'Pain', 'Pain in extremity', 'Pruritus', 'Rash', 'Rash erythematous', 'Rash maculo-papular', 'Stomatitis', 'Swelling', 'Urethral meatus stenosis', 'Urethritis']",UNK,PFIZER\BIONTECH,IM 1033614,FL,42.0,F,Patient received first Moderna vaccine on 1/15/2021. Delayed injection site reaction which was warm and erythematous 1 week after vaccination on left arm for which was seen by PCP and prescribed Bactrim for 10 days. On 2/3/21 patient experienced itchiness in hands and feet with pins and needles sensation. Seen by PCP on 2/4/21 and was started on Medrol Dose Pack for pruritis and paresthesias. 2/10/21 presented to ED with progressive sensory motor polyneuropathy and early gait dysfunction. Patient started plasmapharesis treatment for suspected Guillan-Barre Syndrome on 2/11/2021.,Not Reported,,Not Reported,Yes,,Not Reported,,01/15/2021,01/22/2021,7.0,PVT,,,"Sjogren's syndrome, hypothyroidism, anemia",,"Latex, tramadol","['Autoimmune demyelinating disease', 'CSF protein increased', 'CSF white blood cell count negative', 'Cauda equina syndrome', 'Computerised tomogram head normal', 'Gait disturbance', 'Guillain-Barre syndrome', 'Injection site erythema', 'Injection site reaction', 'Injection site warmth', 'Lumbar puncture abnormal', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging spinal abnormal', 'Paraesthesia', 'Peripheral motor neuropathy', 'Peripheral sensory neuropathy', 'Plasmapheresis', 'Protein total increased', 'Pruritus', 'White blood cell count decreased']",1,MODERNA,IM 1033648,OR,61.0,M,"approximately 1 week post 1st dose, patient had sensation of foreign body in throat; some pain in neck; & facial swelling",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/05/2021,02/12/2021,7.0,PVT,Amlodipine; Aspirin; Atropine 1% solution; Atrovastatin Calcium; Gabapentin; Glimepiride; Lactulose; Lorazepam; Melatonin; Omeprazole; Oxycodone; Prednisolone acetate; whey protein; spironolactone; timolol; Vitamin D-3; Auryxia Oral; Lokel,see long standing conditions,"end state renal disease with hemodialiysis; peripheral vascular disease, blindness due to glaucoma; diabetes; anemia; hypertension; costomanubiral septic arthritis; sick sinus syndrome; GERD; gout; hyperlipidemia",,Calcitriol- Nausea and vomiting. Clindamycin- Nausea. Dicloxacillin Sodium- Nausea and vomiting. Doxycycline- Unknown. FentaNYL- Disorientation. Morphine- Itching and emesis. Paxil- Homicidal ideation. Tape- Blisters..,"['Alanine aminotransferase normal', 'Albumin globulin ratio decreased', 'Anion gap', 'Anion gap increased', 'Arteriogram carotid abnormal', 'Arthralgia', 'Aspartate aminotransferase normal', 'Basophil count normal', 'Basophil percentage decreased', 'Blood albumin decreased', 'Blood alkaline phosphatase increased', 'Blood bilirubin decreased', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine increased', 'Blood glucose increased', 'Blood potassium normal', 'Blood sodium decreased', 'Blood urea increased', 'Blood urea nitrogen/creatinine ratio decreased', 'C-reactive protein increased', 'Carbon dioxide decreased', 'Computerised tomogram neck', 'Creatinine renal clearance normal', 'Differential white blood cell count normal', 'Eosinophil count decreased', 'Eosinophil count normal', 'Eosinophil percentage', 'Globulin', 'Glomerular filtration rate decreased', 'Haematocrit decreased', 'Haemoglobin decreased', 'Lymphocyte count', 'Lymphocyte percentage', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin increased', 'Mean cell haemoglobin normal', 'Mean cell volume increased', 'Mean platelet volume normal', 'Monocyte count decreased', 'Monocyte count increased', 'Monocyte percentage', 'Neck pain', 'Neutrophil count', 'Neutrophil percentage increased', 'Nucleated red cells', 'Oropharyngeal stenosis', 'Platelet count normal', 'Protein total normal', 'Red blood cell count decreased', 'Red cell distribution width increased', 'Retroperitoneal effusion', 'Sensation of foreign body', 'Swelling face', 'White blood cell count normal']",1,MODERNA,IM 1033682,WI,95.0,M,"L hand edema, hematoma which burst and caused bleeding sending pt to the ER for pressure dressing and 2 stitches. L hand and arm progressively got more edematous and bruised looking (severely black/blue/purple) and the hand continued to bleed and swell on 2/6/21. Severe arterial and venous issues and apparent blood clots. On 2/7/21 there were also lumps noted on left inner thigh. Pt. stopped eating or drinking on 2/8/21 and expired on 2/12/21.",Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,SEN,"metoprolol tartrate 25 mg, 81 mg aspirin, 10 mg lisinopril, 2 mg glimepride, 20 mg furosemide (lasix)","polycythemia vera, dementia, type 2 diabetes mellitus, HTN",Type II DM,,none,"['Arterial disorder', 'Contusion', 'Death', 'Dysphagia', 'Haematoma', 'Haemorrhage', 'Limb mass', 'Oedema peripheral', 'Peripheral swelling', 'Skin discolouration', 'Suture insertion', 'Thrombosis', 'Vein disorder']",2,PFIZER\BIONTECH,IM 1033683,MN,75.0,F,Chills and muscle weakness that started on 2/13 PM and then mom suffered a basal ganglia stroke on 2/14 PM.,Not Reported,,Yes,Yes,,Yes,N,02/13/2021,02/14/2021,1.0,PVT,Glipizide 5mg daily Rosuvastatin 10mg daily on M W F KCl 20meq BID Iron 325mg BID Metformin 1000mg BID Losartan 50mg daily Lasix 20mg daily Vitamin C 500mg daily B complex daily Niacin 50mg daily Fish Oil 1000mg daily CoQ10 daily Aspirin 81,None,Diabetes Hypertension High Cholesterol Anemia,,None,"['Basal ganglia stroke', 'Chills', 'Computerised tomogram', 'Intensive care', 'Laboratory test', 'Magnetic resonance imaging', 'Muscular weakness']",2,PFIZER\BIONTECH,IM 1033734,KY,70.0,M,1st Vaccine 2/6/21; developed chest pain with SOA on exertion 2/13/21; Seen in ED 2/16/21 for worsening symptoms and admitted to hospital.,Not Reported,,Not Reported,Yes,,Not Reported,N,02/06/2021,02/13/2021,7.0,PVT,,,Hx MI 7/6/2020,,,"['Chest pain', 'Condition aggravated', 'Dyspnoea']",1,PFIZER\BIONTECH,IM 1033762,CA,92.0,F,Prt tested + 1/31/21; GOC comfort focused and no hospitalization. Pt passed away on 2/16/21.,Not Reported,,Yes,Not Reported,,Not Reported,,01/14/2021,02/16/2021,33.0,OTH,"sinemet, morphine",,"advanced dementia, vascular PD, HTN,",,"hydroxyzine, cefaclor","['COVID-19', 'Death']",UNK,PFIZER\BIONTECH, 1033768,NE,42.0,F,"Vaccine given 1-6-21, patient had a stroke left occluded carotid with dissection 1-11-21, no risk factors. 1-20-21 had second stroke, hospitalized for both episodes without residual symptoms.",Not Reported,,Yes,Yes,,Not Reported,Y,01/06/2021,01/11/2021,5.0,UNK,Citalopram 20mg daily,none,none,,"PCN: hives, Codeine: nausea","['Angiogram', 'Angiogram cerebral', 'Carotid artery occlusion', 'Cerebrovascular accident', 'Computerised tomogram neck', 'Magnetic resonance imaging brain', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH, 1033802,CT,69.0,M,"Headache, right sided parenthesis periorsl numbness confusion",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/16/2021,02/16/2021,0.0,PVT,"Lisinopril, metoprolol, omeprazole, term solution, rosuvastatin, Ferris sulfate, alprazolam",None,"Htn, hld",,No,"['Computerised tomogram head normal', 'Confusional state', 'Full blood count normal', 'Headache', 'Hypoaesthesia oral', 'Laboratory test normal', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 1033843,AZ,94.0,M,"2/12/2021 @ 5:30 started to develop rapid heartbeat, high pulse of 175, called 911, transported to hospital, treated by shocking(incorrect term) kept overnight discharged 2/13 afternoon. Next incident was 2/15 @ 5:00am same series of events and is still currently at hospital still being treated as of 2/16/21 afternoon.",Not Reported,,Yes,Yes,5.0,Not Reported,N,02/12/2021,02/12/2021,0.0,OTH,"amiodarone, lisinopril, metorprolol, tamsulosin,",Tachycardia Ventricular,Tachycardia Ventricular,,nka,"['Cardioversion', 'Heart rate increased']",2,PFIZER\BIONTECH,IM 1033873,IL,25.0,F,PATIENT PASSED AWAY ON 2-1-2021,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,U,01/20/2021,02/01/2021,12.0,PHM,"VENLAFAXINE, LOSARTAN, TRAZODONE. THERE MAY BE OTHERS. SHE WAS PARTICIPATING IN A CLINICAL TRIAL",,CHRONIC KIDNEY DISEASE,,UNKNOWN,['Death'],2,PFIZER\BIONTECH,IM 1033876,MO,70.0,M,"EMS reported around 3:30 pm, patient started not feeling right. He had some tingling sensation in his left arm. Per family patient had slurred speech was not acting right. He did slide out of the chair he was sitting in. He was ambulatory on scene. Symptoms lasted approximately 5 minutes and then gradually resolved. Upon arrival to the emergency department symptoms had significantly improved. Patient reports he is feeling a lot better. Patient did receive his second covid vaccination 2 hours prior to arrival. His never had a stroke in the past. Patient was otherwise feeling at baseline earlier today. No chest pain shortness breath nausea vomiting diarrhea comes patient fever chills headache.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/12/2021,02/12/2021,0.0,UNK,Atorvastatin 20 mg daily glimepiride 4 mg BID lisinopril 20 mg bid metformin 1000 mg BID rivaroxaban 20 mg daily tramadol 50 mg q4h prn dofetilide 250 mcg bid carvedilol 6.25 mg po BID MVI daily,,"diabetes, dyslipidemia, a fib",,NKA,"['Angiogram cerebral normal', 'Arteriogram carotid normal', 'Computerised tomogram', 'Computerised tomogram head normal', 'Dysarthria', 'Feeling abnormal', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 1033920,NE,86.0,F,"Nausea, Confusion, fever, weakness, SOB, pain",Not Reported,,Not Reported,Yes,,Not Reported,U,12/31/2020,01/28/2021,28.0,SEN,"Allopurinol, Breo, Calcium, Diclofenac, Potassium, Levothyroxine, Preservision, Ropinirole, Solifenacin, Toresemide, Vit. D3",,"Gout, Cellulitis, Osteoarthritis, muscle weakness, major depressive disorder, Anxiety, edema, chronic pain, RLS, HTN, GERD, Acute URI's, Vit D deficiency, Paralytic ileus, fibromyalgia, dementia, repeated falls, syncope, carpal tunnel syndrome, stress incontinence",Similar results following the 1st dose of COVID Vaccine,"PCN, Codeine, Sulfacetamide","['Asthenia', 'Confusional state', 'Dyspnoea', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,IM 1033953,MD,68.0,F,"tip of nose was numb, top lip, chin, forehead cheeks were also numb, eyes felt different",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,OTH,,,,,,['Hypoaesthesia'],1,PFIZER\BIONTECH,IM 1033966,WI,91.0,M,"post vaccine fever, hypoxia, pulmonary embolisms",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/09/2021,02/10/2021,1.0,SEN,"Metformin, Levothyroxine, Aspirin 81mg, Sertraline, atrovastat",UTI,"type 2 diabetes, hx stroke, hx covid (Nov. 2020)",,NKA,"['Hypoxia', 'Pulmonary embolism', 'Pyrexia']",2,MODERNA,IM 1034014,AL,70.0,M,central retinal vein occlusion involving the right eye,Not Reported,,Not Reported,Not Reported,,Yes,N,01/28/2021,02/04/2021,7.0,PVT,,,Sleep apnea,,NKDA,"['Angiogram retina', 'Fundoscopy', 'Optical coherence tomography', 'Retinal vein occlusion']",UNK,MODERNA, 1034032,MI,75.0,F,What I know so far is they gave her the shot her heart stopped for about 3-4 minutes they did cpr until the ambulance got there they took her to main. They are going to do a bunch of test . They are going to keep her she has too see the cardiologist they are going to do an eco cartogram and an ultrasound of her heart. They had to my mom on a ventilator because they where putting the defibrillator in and she started throwing up and they had to do compression again cause her heart stopped again and she stopped breathing,Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/11/2021,02/11/2021,0.0,OTH,"81 mg aspirin. Metoprolol 50mg, citalopram 20mg ,Aleve",None,Heart problems in 2014,,Penicillin,"['Cardiac arrest', 'Cardioversion', 'Mechanical ventilation', 'Respiratory arrest', 'Resuscitation', 'Vomiting']",2,PFIZER\BIONTECH,SYR 1034055,MD,52.0,M,Associate developed SOB on 2/12/21. Taken to Hospital on 2/13/21. Reported deceased 2/14/21.,Yes,02/14/2021,Not Reported,Yes,2.0,Not Reported,N,02/11/2021,02/12/2021,1.0,PVT,UNKNOWN,Kidney Failure- on dialysis,Kidney Failure- on dialysis,,UNKNOWN- none reported,"['Death', 'Dyspnoea']",2,PFIZER\BIONTECH,IM 1034073,CO,80.0,M,"81 YOM with hx of RA, PUD and HLD presents to GVH ED with 3 days of LUQ abdominal pain. He states pain stared after he received his 2nd mederma covid vaccination. He stats 1-2 days after 2nd shot on 1/28 he had expected fever and chills but then developed LUQ pain worse with inspiration. Pain is minimal at rest and no other associated sx, denies CP, SOB (only hurts with deep breath) adn no N/V. CT abd/pel with contrast showed multiple peripheral wedge-shaped hypoenhancing dense regions consistent with splenic infarcts . Pt was placed in observation for starting AC and monitoring on tele.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/28/2021,01/30/2021,2.0,PVT,"Atorvastatin Calcium 10MG Oral Tablet 10 MILLIGRAMS ORAL daily at bedtime Methotrexate 25MG/1ML Injection Solution 1 EACH INJECTION Omeprazole 20MG Oral Capsule, Delayed Release 20 MILLIGRAMS ORAL daily sulfaSALAzine 500MG Oral Tablet 5",none,"81 YOM with hx of RA, PUD and HLD",,none,"['Abdominal pain upper', 'Chills', 'Computerised tomogram abdomen', 'Painful respiration', 'Pyrexia', 'Splenic infarction']",UNK,MODERNA, 1034104,CO,59.0,M,"Nausea, vomiting, increased heart rate (217bpm at time of paramedics arrival), crushing chest pain, massive headache, and fever. Hospital gave me fluids, took blood test, EKG, and x-rays then sent me home. Increased heart rate lasted approximately one week. Headache lasted two weeks.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,OTH,Atorvastatin (40mg) - Omeprazole (20mg) - Sertraline (200mg) - Metformin 1000mg x2) - Tresiba (180U) - Losartan (25mg) - Low dose aspirin (81mg),"COVID_19 (Dec 3, 2020)",Diabetes,,Penicillin,"['Blood test normal', 'Chest pain', 'Electrocardiogram normal', 'Headache', 'Heart rate increased', 'Nausea', 'Pyrexia', 'Vomiting', 'X-ray normal']",UNK,MODERNA,SYR 1034114,CA,76.0,F,Started having fever chills nausea and diarrhea and felt short of breath on 2/13. SOB and diarrhea was better on 2/14 bug then on 2/15 pt started to feel chest pressure. pt admitted to hospital on 2/15 noted to have NSTEMI and plt=68. Thrombocytopenia is new for pt. on 2/16 plt=79. pt has been on ibrance for years for hx of breast ca- has never had thrombocytopenia related to the ibrance.,Not Reported,,Not Reported,Yes,,Not Reported,,02/12/2021,02/13/2021,1.0,UNK,,,,,,"['Acute myocardial infarction', 'Chest discomfort', 'Chills', 'Diarrhoea', 'Dyspnoea', 'Nausea', 'Platelet count decreased', 'Pyrexia', 'Thrombocytopenia']",UNK,PFIZER\BIONTECH, 1034116,VA,58.0,F,Presented from clinic with 3-4 days of extensive rash. There were multiple areas of skin sloughing on bilateral upper extremities and abdominal wall.,Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/30/2021,11.0,SEN,Escitalopram 10mg tablet Novolin 70/30 Insulin Diazepam 2mg tablet Simvastatin 20mg tablet Acetaminophen 500mg tablet,Diabetes - Type 2 Dementia CVA s/p L-sided weakness Psychiatric disorder,,,Buspirone Morphine,"['Biopsy skin abnormal', 'Blister', 'Dermatitis', 'Epidermal necrosis', 'Rash', 'Skin exfoliation', 'Toxic epidermal necrolysis']",2,PFIZER\BIONTECH,IM 1034125,AK,44.0,F,"Severe dizzyness, vomiting, tongue swelling,. Took ambulance to hospital. Stay at hospital 6 hours. Started at home for there days from work. Tongue and throat are still sore.",Not Reported,,Yes,Not Reported,,Not Reported,,02/10/2021,02/10/2021,0.0,PUB,"Singlar 10 mg, advair 250, multi vitamin, vit. D.",None,Aathma,,"Atropine, iodine, sulfur, seafood","['Blood test', 'Dizziness', 'Glossodynia', 'Oropharyngeal pain', 'Swollen tongue', 'Vomiting']",1,PFIZER\BIONTECH,IM 1034146,AZ,28.0,M,"ARRIVED AT EVENT, CONSENT FORM COMPLETED, DID NOT REPORT HE HAD BEEN ILL, DID NOT REPORT THAT HE TOOK ANY FEVER REDUCING MEDICATIONS",Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/14/2021,1.0,PVT,,WAS NOT REPORTED AT TIME OF VACCINATION,,,UNKNOWN,['Unevaluable event'],1,MODERNA,IM 1034158,MT,77.0,M,"Chills, headache, body aches, oral mucous membrane burning, runny and stuffy nose, feet ""hot"", cough, chest pain, difficulty breathing, crampy abdominal pain, rash - Henoch-Schonlien purpura purpura and petechiae, edema, proteinuria, hematuria, decreased appetite, dizziness",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/02/2021,02/02/2021,0.0,PUB,"Flonase, Metformin, losartan, flomax.",COVID-19 positive 01/07/2021.,"Hypertention, irregular heart rate, diabetes.",,No known allergies.,"['Abdominal pain', 'Blood test', 'Chest pain', 'Chills', 'Computerised tomogram thorax', 'Cough', 'Decreased appetite', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Feeling hot', 'Haematuria', 'Headache', 'Henoch-Schonlein purpura', 'Nasal congestion', 'Oedema', 'Oral discomfort', 'Pain', 'Petechiae', 'Proteinuria', 'Purpura', 'Rash', 'Rhinorrhoea']",1,MODERNA,IM 1034182,CO,82.0,M,"Approximately 2 weeks post vaccination developed rapid AF, CHF. Admitted to Medical Center. Discharged home on hospice. Patient died at home on 2/13/2021. Reported to this reporter at second dose clinic on 2/16/21. Other details not known. Unknown if related to vaccine.",Yes,02/13/2021,Not Reported,Yes,10.0,Not Reported,N,01/29/2021,02/01/2021,3.0,PVT,Symbicort inhaler 2 puffs BID Cardura 8 mg PO daily Oxygen at night,OSA started on oxygen at night Dysphagia - work up,"Sleep apnea Joint inflammation Hypoxia Past history of MI Hyperlipidemia Back pain Alcohol abuse Hearing loss Nodular hyperplasia of the prostate Asthma TIA Atrial fibrillation, new onset",,None Known,"['Anaemia', 'Atrial fibrillation', 'Atrial flutter', 'Cardiac failure congestive', 'Condition aggravated', 'Coronary artery disease', 'Death', 'Dyslipidaemia', 'Essential hypertension', 'Left ventricular failure', 'Liver function test abnormal', 'Mitral valve incompetence', 'Renal failure', 'Renal tubular necrosis', 'Thrombocytopenia', 'Troponin increased']",1,PFIZER\BIONTECH,IM 1034192,CO,74.0,F,Patient presented with spontaneous IVH of small vessel origin with essentially no past medical history. She then acutely developed mesenteric ischemia. Died due to all dead small bowel which also appeared to be small vessel disease and not embolic/thrombotic. This process started one week after,Yes,02/16/2021,Not Reported,Yes,13.0,Not Reported,N,02/01/2021,02/03/2021,2.0,OTH,"Fosamax, Cosopt soln, Emollient, Xalantan soln, Effient, Zocor","Glaucoma, HLD","Glaucoma, HLD",,none,"['Cerebral small vessel ischaemic disease', 'Death', 'Intestinal infarction', 'Intestinal ischaemia', 'Intraventricular haemorrhage']",UNK,MODERNA, 1034217,CA,41.0,F,Within 12 hours was having trouble breathing heart pounding thought I could just rest and could not it was so bad went to the ER on 2/14/21 @ 8:30 am my O2 was at 87 dropped to 81 BP was 158/101,Not Reported,,Yes,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,PVT,,,,,,"['Blood test normal', 'Dyspnoea', 'Electrocardiogram normal', 'Oxygen saturation decreased', 'Palpitations', 'SARS-CoV-2 test negative', 'X-ray normal']",2,MODERNA,SYR 1034234,CO,88.0,F,Eye Stroke / Retinal Occlusion Lost eyesight in left eye,Not Reported,,Not Reported,Not Reported,,Yes,N,01/28/2021,01/28/2021,0.0,PUB,Amlodipine 10MG Atorvastatin 40MG Calcium Carbonate 600MG Cholecalfiferol (Vitamin D3) Clopidogrel 75MG Mirtazapine 7.5 MG tablet Multivitamin Oxbutynin 5 MG Xarelto 20 MG,,High Cholesterol High Blood Pressure,,Ibuprofen/Shortness of breath Ace Inhibitors/Cough Codeine/Headaches Levaquin/Diarrhea Penicillins/Hives Sulfa Antibiotics/Rash Tetanus Toxoid/Hives,"['Blindness unilateral', 'Cerebrovascular accident', 'Magnetic resonance imaging', 'Retinal vascular occlusion', 'Ultrasound scan']",UNK,PFIZER\BIONTECH,SYR 1034252,NY,51.0,F,"After 1st dose 1/6/21 at 6:10am I had severe chest pain, Went to ER . Had a cardiac cath that day and a stent placed in my LAD",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/05/2021,02/16/2021,42.0,UNK,"Otzela, Losartan, Metroprol, Fluoxetine, Asprin, Zyrtec, valacyclovir",None,"Hypertension controlled, Elevated Cholesterol ,",,None,"['Angiogram', 'Blood test', 'Catheterisation cardiac', 'Chest pain', 'Stent placement']",1,MODERNA,IM 1034259,MT,93.0,M,hospitalized with extensive bilateral pulmonary emboli and right leg deep vein thrombosis after 1st vaccine dose. Required high-flow nasal canula for oxygen support. ultimately discharged on hospice,Not Reported,,Yes,Yes,7.0,Yes,N,01/25/2021,02/09/2021,15.0,SEN,"Flomax, pepdic, iron, Tylenol, zocor, vit D, citracal",Diagnosed with COVID-19 on 1/11/2021,"prostate cancer, hyperlipidemia, GERD","allergy listed to ""tetanus toxoid"". reaction unknown","penicillin, tetanus toxoid","['Computerised tomogram abnormal', 'Deep vein thrombosis', 'Pulmonary embolism', 'Ultrasound Doppler', 'Ultrasound scan abnormal']",1,PFIZER\BIONTECH,IM 1034281,AL,34.0,F,Pt received vaccine and was waiting in post IMZ waiting area. Pt started to complain of her mouth tingling and swelling. I grabbed an epinephrine injector and went to assist. When I got close to pt she started to pass out. 911 was called and pt was administered a dose of epinephrine and she revived enough to speak coherently. Shortly after emts arrived and took pt to hospital.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/16/2021,02/16/2021,0.0,PHM,,,,,,"['Dizziness', 'Mouth swelling', 'Paraesthesia oral']",1,MODERNA,IM 1034309,NJ,36.0,F,"Approximately 10-15 minutes after vaccine administration patient reported mild purtius. flat blotchy areas of redness noted on both sides of neck. Denied any difficulty breathing. Client already took 25 mg of bendaryl, singulair and pepcid at 9 am as prophalaxis. Denied having any side effects from 1st vaccine other then soreness at injection site. Declined epipen when blotches occured. Case did agree and take bendaryl 25mg approximately 10:15-10:20. Puritus continued to increase. redness only around neck and upper chest. no other rashes. Pulse 104 Respirations 24. Developed slight coughing. Did report has history of cough and chronic cystic lung. Denied any difficulty breathing, however, puritus increased and still with occasional coughing. Alert and oriented. Mother was also present and had received vaccine at same time today. Agreed to take epi-pen since symtpoms were not improving. Sheriff's dispatched 911, before this nurse administered epi pen into Left thigh. Case remained alert and oriented. No respiratory distress. EMT arrived at scene, followed by paramedics and ambulance. Paramedics administered nebulizer outside of facility prior to getting in ambulance. Case was taken to Medical Center. Case had already called and notified her MD. Called hospital tonight at pm. Spoke with nurse who reported she is stable and in the ICU for observation. She received additional epinepherine and solumedrol in hospital. She is alert and oriented x3",Not Reported,,Not Reported,Yes,,Not Reported,,02/16/2021,02/16/2021,0.0,PUB,"Pt reported she took medications prophalacticaly one hour prior to vaccination appt 9 am 2/16/2021 singulair, benadryl 25 mg and pepcid",,"History of chronic cystic lung disease, mast cell autoimmune disease, Barrett's esophagus",,Has history of anaphalaxis and use of epi-pens in the past Hast history of mast cell autoimmune disease,"['Condition aggravated', 'Cough', 'Erythema', 'Injection site pain', 'Pruritus', 'Rash macular']",2,MODERNA,IM 1034337,CA,82.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA The first symptoms to appear at approximately 8:00 pm on Feb. 9th the day of my mom?s vaccine were headache and diarrhea. The following day, 2/10 she seemed to feel better and went on with her day. The night of 2/10 she awoke coughing and wheezing. She called 911 at approximately 4:45 am on 2/11. They transported her to hospital.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/09/2021,02/09/2021,0.0,PVT,"Losartan, warfarin, amiodarone, metoprolol, clonazepam, cholecalciferol, ezetimibe, gabapentin,.",None,"Heart valve repair, afib",,Penicillin,"['Chest X-ray abnormal', 'Cough', 'Diarrhoea', 'Headache', 'Pneumonia', 'Wheezing']",UNK,PFIZER\BIONTECH,SYR 1034349,CA,90.0,F,"Patient awoke on 2/12/21 with altered mental status, confusion, respiratory distress, was taken to hospital by ambulance. Per ED notes from ED attending Pt presented with hypotension and respiratory distress. DNR status, patient given comfort measures and passed away in ED at 11:24 am on 2/12/21.",Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/12/2021,2.0,PVT,Amlodipine 2.5 mg BID Metformin 500 mg BID Losartan 100 mg qd Simvastatin 10 mg qd Levothyroxine 50 mcg qd torsemide 20 mg qd,Unknown,Congestive heart failure Hypertension Type 2 Diabetes Chronic venous insufficiency Hypothyroidisn Coronary artery disease Dyslipidemia,,None,"['Activated partial thromboplastin time', 'Alanine aminotransferase normal', 'Anion gap', 'Aspartate aminotransferase increased', 'Basophil count normal', 'Basophil percentage', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bicarbonate decreased', 'Blood bicarbonate increased', 'Blood bilirubin normal', 'Blood calcium normal', 'Blood chloride increased', 'Blood chloride normal', 'Blood creatinine increased', 'Blood gases abnormal', 'Blood glucose increased', 'Blood magnesium increased', 'Blood methaemoglobin', 'Blood potassium normal', 'Blood sodium decreased', 'Blood urea normal', 'Carbon dioxide decreased', 'Carboxyhaemoglobin decreased', 'Confusional state', 'Death', 'Differential white blood cell count', 'Electrocardiogram normal', 'Eosinophil count normal', 'Eosinophil percentage', 'Fibrin D dimer increased', 'Fraction of inspired oxygen', 'Full blood count', 'Glomerular filtration rate decreased', 'Haematocrit decreased', 'Haemoglobin decreased', 'Hypotension', 'Influenza A virus test negative', 'Influenza B virus test', 'International normalised ratio increased', 'Lymphocyte count', 'Lymphocyte percentage', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Mental status changes', 'Metabolic function test', 'Methaemoglobin urine absent', 'Monocyte count decreased', 'Monocyte percentage', 'N-terminal prohormone brain natriuretic peptide increased', 'Neutrophil count', 'Neutrophil percentage', 'Nucleated red cells', 'Oxygen saturation normal', 'PCO2 decreased', 'PO2 increased', 'Platelet count decreased', 'Protein total normal', 'Prothrombin time prolonged', 'Red blood cell count decreased', 'Red cell distribution width normal', 'Respiratory distress', 'SARS-CoV-2 test negative', 'Troponin I increased', 'White blood cell count normal', 'pH urine normal']",1,MODERNA,IM 1035891,VA,92.0,F,Felt nauseated afteR Receiving vaccination. Did not eat or drink afteRwards. Stated had small emesis. Found on flooR in Bathroom with walker on top of heR 1230 AM 2/14/2021. Stated had lost consciousness. Side effects are as described to attending nurse.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/12/2021,02/12/2021,0.0,SEN,"Cosopt, Tylenol prn Eliquis, Toprol-XL, Pravachol, Vascepa, Travatan gtts",,DM Type II HTN,,NKA,"['Decreased appetite', 'Fall', 'Fluid intake reduced', 'Loss of consciousness', 'Nausea', 'Vomiting', 'Walking aid user']",2,MODERNA,IM 1036008,NY,55.0,F,"C/O dizziness became clammy, radial pulse thready and unable to count @ first vital signs monitored, given Epi 0.3 mg right thigh @ 9:52 AM, vital signs monitored, EMT called and transported to Hospital",Not Reported,,Not Reported,Yes,,Not Reported,U,02/09/2021,02/09/2021,0.0,OTH,unknown,unknown,Ulcerative colitis,,"Sulfa,Codeine","['Cold sweat', 'Dizziness', 'Pulse abnormal', 'Pulse absent']",2,MODERNA,IM 1034599,HI,60.0,F,"Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for about 10-12 hours, then lessening to feeling tired, bouts of vertigo and occasional headache. Five days later on 1/25 I experienced blurry vision, nausea, confusion, dizziness, and impaired speech (to a co-worker). This lasted about an hour.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/18/2021,01/19/2021,1.0,PVT,None,None,None,,None,"['Angiogram', 'Blood test', 'Chills', 'Confusional state', 'Dizziness', 'Echocardiogram', 'Electrocardiogram', 'Fatigue', 'Headache', 'Magnetic resonance imaging', 'Nausea', 'Speech disorder', 'Vertigo', 'Vision blurred']",2,PFIZER\BIONTECH,SYR 1034613,WA,51.0,M,"For two days after receiving the first vaccination for Covid-19 I ran a temperature of 101.9 and was not able to go to work. When I returned to work on Friday February 12, 2021 at approximately 8:40am I had a stroke and was rushed by ambulance to the hospital.",Not Reported,,Yes,Yes,1.0,Not Reported,N,02/09/2021,02/10/2021,1.0,PVT,none,none,Type 1 Diabetic,,none,"['Blood test', 'Body temperature increased', 'Cerebrovascular accident', 'Computerised tomogram', 'Electrocardiogram', 'Impaired work ability', 'Magnetic resonance imaging brain abnormal']",1,MODERNA,IM 1034979,TX,,F,"Chest started getting tight; Coughing; Fever; Pneumonia; Positive for covid; A spontaneous report was received from Healthcare Professional concerning a 75-year-old, female patient who received Moderna's COVID-19 vaccine and experienced fever/ pyrexia, cough, tested positive for covid/ COVID-19, pneumonia, and chest started getting tight/ chest discomfort. The patient's medical history was not provided. Concomitant product use was not provided. On 11 Jan 2021 prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an undisclosed date, the patient experienced fever and cough. Her chest started getting tight when doing breathing exercises at home. On 15 Jan 2021, the patient tested positive for COVID-19. On 18 Jan 2021, the patient also tested positive for pneumonia. The treatment included bamlanivimib. The action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events, fever, cough, chest started getting tight, tested positive for covid, and tested positive for pneumonia, was unknown.; Reporter's Comments: Although a temporal association exist, based on the known etiology for COVID-19, a causal association between the product use and events of cough, COVID-19, pneumonia and chest discomfort is considered unlikely. The patient most likely had pre-existing COVID infection and the other events are complications from the disease. Fever is consistent with the safety profile of the product and a causal association cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/15/2021,4.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['COVID-19', 'Chest discomfort', 'Cough', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test']",1,MODERNA,OT 1034980,,,M,"Hallucinations; A spontaneous report was received from a consumer concerning 72-year-old male. The patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hallucinations, seeing ghost. The patient's medical history was not provided. Concomitant product use was not provided. Prior to the onset of symptoms, on an known date, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided), for prophylaxis of Covid-19 infection. On 01 Feb 2021 the patient left a voicemail message to Safety stating that he began having, ""what I guess you would call hallucinations"" after receiving his first dose of Covid -19 vaccination. He further stated, "" I've seen ghosts"". ""I've never seen ghosts in my life before"". The patient then went on to ponder whether the event was vaccine related or possibly related to the fact that he experienced a problem in his eye some years ago that caused him to ""see weird things"". No treatment or other relevant information was provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event hallucinations was unknown at the time of the report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,"Medical History/Concurrent Conditions: Blurry vision; Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No adverse event, Continue: [UNK], Comment: No reported medical history",,,['Hallucination'],1,MODERNA, 1034982,MA,33.0,F,"Possibly Mastitis; Breast was hard, red, and sore; Milk production dropped; Clogged duct; Flu like symptoms; Received vaccine while breastfeeding; A spontaneous report was received from a consumer who was also a 33-years-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced received vaccine while breastfeeding (maternal exposure during breast feeding), clogged duct (galactostasis), possible mastitis (mastitis), flu like symptoms (influenza like illness), milk production dropped (suppressed lactation), and breast was hard, red, and sore (breast tenderness). The patient's medical history included eczema. Products known to have been used by the patient, within two weeks prior to the event, included pre-natal vitamins. The patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) on 31 Dec 2020. On 28 Jan 2021, approximately one day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (batch number 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient received the vaccine while breastfeeding and reported having a clogged duct and possible mastitis. She began to experience flu like symptoms on 29 Jan 2021. She had a fever and missed pumping breast milk. On 30 Jan 2021 her milk production was about half of the typical amount. The flu like symptoms resolved on 31 Jan 2021. On 01 Feb 2021 her breast became hard, red, and sore. On 02 Feb 2021 her breast symptoms resolved; however, her milk production was 65-70% of normal. She treated the events with acetaminophen and magnesium sulfate dissolved in water. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable. The outcome of the events clogged duct, possible mastitis, milk production dropped, and were not reported. The outcome of the event, received vaccine while breastfeeding, was considered resolved on 28 Jan 2021. The outcome of the event, flu like symptoms, was considered resolved on 31 Jan 2021. The outcome of the event, breast was hard, red, and sore, was considered resolved on 02 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,UNK,PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS],,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Breast tenderness', 'Galactostasis', 'Influenza like illness', 'Mastitis', 'Maternal exposure during breast feeding', 'Suppressed lactation']",2,MODERNA,OT 1034985,KY,,U,"4 Nurshing home patients Died; A Spontaneous report was received from a pharmacist concerning 4 nursing home patients of unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and died. The patients' medical histories were not provided. No relevant concomitant medications were reported. On unspecified dates, 4 nursing home patients received their first of two planned doses of mRNA-1273 (Lot # 039K20A) for prophylaxis of COVID-19 infection. A pharmacist reported that they just learned 4 nursing home patients died after the first dose of the Modern vaccine. The patients were buried, and no autopsies were conducted. The pharmacist suspected latent Covid-19 on the patients and that the vaccine precipitated this outcome. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not applicable. The event 4 nursing home patients died was fatal.; Reporter's Comments: This case concerns 4 nursing home patients of unspecified age and gender who received their first dose of Moderna's COVID-19 vaccine (mRNA-1273)Lot # 039K20A) and died. Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: died",Yes,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Death'],1,MODERNA,OT 1034986,IL,71.0,M,"Ringing in left ear; Hearing loss in right ear; Ear ringing in right ear; Mild soreness at the site of injection; A spontaneous report was received from a consumer, a 71 year-old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hearing loss in right ear/deafness unilateral, ear ringing in right ear/tinnitus, ringing in left ear/tinnitus, and mild soreness at the site of injection/injection site pain. The patient's medical history included a kidney transplant. Concomitant product use was not provided. On 19 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch number: 029L20A) in the left arm for COVID-19 infection prophylaxis. The patient had some mild soreness at the site of the injection which lasted one to two days. On 21 Jan 2021, he experienced some ear ringing in his right ear which was followed by hearing loss that lasted six hours. Both the ear ringing and hearing loss resolved by the next morning. On 24 Jan 2021, the patient had ringing in his left ear, but it was not associated with hearing loss. The patient stated he thinks the tromethamine hydrochloride in the vaccine may have induced his hearing loss. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The events, hearing loss in right ear and ear ringing in right ear, were considered resolved on 22 Jan 2021. The event, mild soreness at the site of injection, was considered resolved on an unknown date Jan 2021. The outcome for the event, ringing in left ear, was unknown.; Reporter's Comments: This case concerns a 71- year old male patient who experienced hearing loss in right ear/deafness unilateral, ear ringing in right ear/tinnitus, ringing in left ear/tinnitus, and mild soreness at the site of injection/injection site pain, all within 4 days after administration of Moderna's COVID-19 Vaccine (mRNA-1273). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Kidney transplant,,,"['Deafness unilateral', 'Injection site pain', 'Tinnitus']",1,MODERNA,OT 1034987,IL,,F,"Diverticulitis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient took her first dose on 15Jan2021 and is scheduled for 05Feb2021. After the first shot, she got sick with diverticulitis and was put on antibiotics. The round of antibiotics will be done 02Feb2021 and on 03Feb2021 she will go through another test. She wanted to know if it is ok to get the second shot after finishing with the antibiotics. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,,,UNK,,,,,,['Diverticulitis'],1,PFIZER\BIONTECH, 1034988,LA,76.0,F,"she hasn't been eating like she should; lost eye sight for 5 minutes, everything was grey; could hear her niece, but that her niece sounded far away; very nauseated/wanted to throw up but couldn't; This is a spontaneous report from a contactable consumer, reporting for herself. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration at the left arm on 29Jan2021 14:00 at a single dose to prevent getting COVID-19. Medical history included cholesterol, high blood pressure, arthritis, medications for her heart, and medication for her stomach. Concomitant medication included amlodipine for high blood pressure and atorvastatin for cholesterol. The patient has been on amlodipine in a good while, 7-8 years and atorvastatin for 5 years. The patient had the COVID shot on Friday, 29Jan2021 at 14:00, and about 4 hours afterward, she had a bad experience. She became very nauseated and lost her sight for 5 minutes. Everything was grey. She was wondering if there is anything she can take afterward. She was scheduled for her next one on 19Feb2021. She was wondering if she will experience the same thing. She has lost about 11 pounds because she has been on a diet. She gave up sugar. After getting the vaccine, she was on her way back. She began to feel very nauseated in the car. Then, all the sudden she wanted to throw up, but couldn't. She couldn't hear her niece or say anything to her. She clarified she could hear her niece, but that her niece sounded far away. She couldn't respond. She rolled the window down to get air in her face. She hadn't eaten. In about 25-30 minutes got better. Since then, she hasn't been eating like she should, so she was still a little nauseated. It has improved though. She got the vaccine in her left arm. Her right arm is mostly metal. She decided to get it because she is over 70 and wanted to prevent getting COVID-19. It was also reported that she was also on an arthritis medication, medications for her heart and a medication for her stomach. She has had no problems with those medications though. The patient underwent lab tests and procedures which included weight: lost on an unspecified date. She has lost about 11 pounds because she has been on a diet. She gave up sugar. The outcome of the events ""lost eye sight for 5 minutes, everything was grey"", ""could hear her niece, but that her niece sounded far away"" and ""very nauseated/wanted to throw up but couldn't"" was recovered on 29Jan2021 while the outcome of all other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,UNK,AMLODIPINE; ATORVASTATIN,,Medical History/Concurrent Conditions: Arthritis; Blood pressure high; Cholesterol; Gastric disorder; Heart disorder,,,"['Blindness', 'Eating disorder', 'Hypoacusis', 'Nausea', 'Weight']",1,PFIZER\BIONTECH, 1034989,NY,76.0,M,"Bells Palsy - Left sided; This is a spontaneous report from a contactable physician. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL9263) intramuscular in left arm on 23Jan2021 at single dose for COVID-19 immunization. Medical history included DMII (Type II diabetes mellitus), Parkinson's disease, and CAD (coronary artery disease). Concomitant medications were not reported. The patient previously took metformin and experienced allergy. Prior to vaccination, patient was not diagnosed with COVID-19; and since vaccination, patient has not been tested. Facility where the most recent COVID-19 vaccine was administered: Other (Public Health Department). On 24Jan2021, the patient experienced Bells Palsy - Left sided. The event required physician office visit (Doctor or other healthcare professional office/clinic visit). No treatment was received for the event. Outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,01/24/2021,1.0,PUB,,,Medical History/Concurrent Conditions: Coronary artery disease; Parkinson's disease; Type II diabetes mellitus,,,['Facial paralysis'],1,PFIZER\BIONTECH,OT 1034990,CA,77.0,M,"ER to bring down temperature and blood pressure; ER to bring down temperature and blood pressure; Stomach cramps; nausea; sever body shakes( uncontrollable); This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 30Jan2021 08:00 at a single dose for covid-19 immunization. Medical history included A-fib. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included apixaban (ELIQUIS), metoprolol, rosuvastatin, furosemide sodium (LASIX) and spironolactone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took aspirin [acetylsalicylic acid] but had allergies. On 31Jan2021 02:00 AM, the patient experienced stomach cramps, nausea and severe body shakes (uncontrollable). They had to call 911 and the patient had to be taken to hospital. The adverse events stomach cramps, nausea and severe body shakes (uncontrollable) resulted in doctor or other healthcare professional office/clinic visit and emergency room (ER)/department or urgent care. The patient received treatment for the adverse events and the patient received treatment in the ER to bring down temperature and blood pressure. The reporter considered the events as non-serious. The patient has been tested for COVID-19 since the vaccination, nasal swab (sars-cov-2 test) with the result of negative on 31Jan2021. The outcome of the events stomach cramps, nausea and severe body shakes (uncontrollable) were recovering while the outcome of the other events was unknown. � The following information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/31/2021,1.0,PVT,ELIQUIS; METOPROLOL; ROSUVASTATIN; LASIX [FUROSEMIDE SODIUM]; SPIRONOLACTONE,,Medical History/Concurrent Conditions: AFib,,,"['Abdominal pain upper', 'Blood pressure increased', 'Body temperature increased', 'Nausea', 'SARS-CoV-2 test', 'Tremor']",UNK,PFIZER\BIONTECH, 1034991,,,F,"a cold that is in her chest; feels as if she has caught the flu; very fatigue; chills; headache; dry throat (feeling as if something is stuck in her throat); dry throat (feeling as if something is stuck in her throat); runny nose; cough; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 60 no unit reported) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that ever since she received the vaccine, she felt as if she has caught the flu. She experienced symptoms such as chills, headache, dry throat (feeling as if something is stuck in her throat), a cold that is in her chest, runny nose, cough, and very fatigue. She stated that she has been taking cold medicine, but it doesn't seem to be working. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,,,UNK,,,,,,"['Chills', 'Cough', 'Dry throat', 'Fatigue', 'Headache', 'Influenza like illness', 'Lower respiratory tract infection', 'Rhinorrhoea', 'Sensation of foreign body']",1,PFIZER\BIONTECH, 1034992,SC,34.0,F,"shortness of breath; throat tightening; Increased HR over 120 bpm; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 29Jan2021 14:30 in left arm, at single dose for covid-19 immunization. Medical history included known allergies: sulfa, and peanuts. Concomitant medication included prednisone. The patient previously took iodine and experienced allergy, and previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 08Jan2021 15:30 in left arm, at single dose for covid-19 immunization and experienced facial swelling within a couple hours of the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the 2nd dose within 30 minutes, 29Jan2021 15:00, the patient had Increased HR over 120 bpm, shortness of breath, dizziness and throat tightening, which all caused hospitalized and Emergency room. Epinephrine injection, fluid, and rest was received as treatment. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Amendment: This follow-up report is being submitted to amend previous reported information: historical vaccine information was added.; Sender's Comments: Based on the compatible time association, the events shortness of breath, dizziness ,throat tightening and heart rate increased are possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/29/2021,01/29/2021,0.0,PVT,PREDNISONE,,Medical History/Concurrent Conditions: Allergy to nuts; Sulfonamide allergy,,,"['Dizziness', 'Dyspnoea', 'Heart rate', 'Heart rate increased', 'Throat tightness']",2,PFIZER\BIONTECH, 1034993,VA,65.0,M,"loss of muscle tone of my cheek and inability to smile on the left side; Loss of sensation of my left cheek from under my eye to my mouth; loss of muscle tone of my cheek and inability to smile on the left side; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), via an unspecified route of administration in the left arm, on 29Jan2021 07:30, at single dose, for COVID-19 immunization, at the hospital. Medical history included hypertension, diabetes, increased cholesterol and COVID-19 prior to vaccination. The patent has no allergies to medications, food, or other products. Concomitant medication included enalapril, hydrochlorothiazide, atorvastatin (LIPITOR), and metformin. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2. The patient was not tested for COVID-19 since the vaccination. The patient experienced ""loss of sensation of my left cheek from under my eye to my mouth. My wife noted loss of muscle tone of my cheek and inability to smile on the left side"" on 29Jan2021 at 08:30. Symptoms started about one hour after the injection and resolved after 3 hours. No treatment was received for the events. The outcome of the events was resolved on 29Jan2021 at 11:30. The reporter assessed the events as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PVT,ENALAPRIL; HYDROCHLOROTHIAZIDE; LIPITOR [ATORVASTATIN]; METFORMIN,,Medical History/Concurrent Conditions: Blood cholesterol increased; COVID-19 (prior to vaccination); Diabetes; Hypertension,,,"['Facial paralysis', 'Hypotonia', 'Sensory loss']",UNK,PFIZER\BIONTECH, 1034994,,84.0,M,"not feeling well; tremors (symptom of Parkinson's which he has but they had been under control with medicine); Gout which has flared occasionally but had not caused problems recently; tremors (symptom of Parkinson's but they had been under control with medicine), and gout which had flared occasionally but had not caused problems recently; This is a spontaneous report from a non-contactable consumer. An 84-year-old male patient received COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included Parkinson's and gout. The patient didn't have COVID prior to vaccination. Concomitant medications were not reported. The patient with other health problems got vaccinated. Next day was not feeling well and the day after was admitted to the hospital complaining of tremors (symptom of Parkinson's which he had but they had been under control with medicine), and gout which had flared occasionally but had not caused problems recently. Adverse events started from 30Jan2021. The events resulted in emergency room/department or urgent care and hospitalization for 1 day. Treatment received included medication for tremors. The outcome of the events was recovering. COVID was not tested post vaccination. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/29/2021,01/30/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Gout (which had flared occasionally but had not caused problems recently); Parkinson's disease (they had been under control with medicine),,,"['Disease recurrence', 'Gout', 'Malaise', ""Parkinson's disease""]",UNK,PFIZER\BIONTECH, 1034995,NJ,67.0,F,"hearing loss/Cannot hear in right ear very well; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration in left arm on 24Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included ongoing blood pressure high. Concomitant medication included levamlodipine besilate for blood pressure high. On 27Jan2021, the patient experienced hearing loss in the right ear, she started to feel like she could not hear very well in her right ear. It was like she was underwater or something. Patient went to see the family doctor on 31Jan2021 because of her ear and the doctor looked in ear and did not see anything wrong. The doctor prescribed an allergy medication, something basic that could be picked up over the counter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/27/2021,3.0,UNK,LEVAMLODIPINE BESYLATE,Blood pressure high,,,,['Deafness unilateral'],1,PFIZER\BIONTECH, 1034996,,86.0,F,"hemorrhagic shingles on opposite arm 4 days after vaccine; This is a spontaneous report from a contactable consumer reported for herself. An 86-year-old female patient (not pregnant at the time of vaccination) received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 15Jan2021 09:00 at single dose in right arm for covid-19 immunisation. Medical history included hypertension, diabetes type 2, depression, no allergies to medications, food, or other products. Prior to vaccination the patient was not diagnosed with COVID-19. The patient received some other medications within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced hemorrhagic shingles on opposite arm 4 days after vaccine on 20Jan2021. The event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included valtrex and medrol pack. The outcome of the event was recovered with lasting effects. The reporter considered the case as non-serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/20/2021,5.0,UNK,,,Medical History/Concurrent Conditions: Depression; Hypertension; Type 2 diabetes mellitus,,,['Haemorrhagic varicella syndrome'],1,PFIZER\BIONTECH, 1034997,CA,93.0,M,"Disorientated; in a lot of pain in his chest and rib area; in a lot of pain in his chest and rib area; hurt to breathe and move; shaken up; Short of breath/It hurt to breathe; Concomitant medication:ongoing prednisone for immunotherapy; Concomitant medication:ongoing prednisone for immunotherapy; This is a spontaneous report from a contactable nurse. A 93-year-old male patient (reporter's father) received first does of BNT162B2 (Lot#: EN5318), via intramuscular on 28Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included ongoing prostate cancer metastatic diagnosed a few years ago and immunotherapy. Concomitant medication included ongoing abiraterone acetate (ZYTIGA) at 1g, once a day for prostate cancer and ongoing prednisone at 5 mg, tablet, twice a day, by mouth for immunotherapy. The caller stated she is reporting a reaction her father had to Pfizer's COVID-19 vaccine. The patient experienced disorientated, in a lot of pain in his chest and rib area, hurt to breathe and move and short of breath/it hurt to breathe on 29Jan2021. The reporter seriousness for the events was medically significant. The events didn't require a visit to emergency room or physician office. The patient did go to urgent care. The caller explained her father became disoriented. He received the first vaccine on 28Jan2021. The next day, her father began to move his car around 12 pm and he became disoriented and stated he wasn't going to drive. Caller stated they were not aware of this disorientation until Friday, 29Jan2021. Her father was not sleeping and was up the night before because he was in a lot of pain in his chest and rib area. It hurt to breathe. He was short of breath. It hurt to move. Caller clarified further her woke up feeling so bad he thought he was going downhill. He thought his cancer got worse over night. He told the caller's brother after he became so disorientated that he was no longer going to drive because he was so shaken up. He was taken to urgent care on Friday, 29Jan2021. He was prescribed Naproxen, 500 mg Friday evening and he slept all night for the first night in years. He usually gets up in the middle of the night to use the bathroom. He woke up on Saturday morning, 30Jan2021, and he was feeling 100% better. He recovered completely. He was up moving around and in no pain. Caller verified she has no NDC, Lot number and expiry date for the Naproxen her father was prescribed. She didn't see any of that written on the discharge papers, that may be with the pharmacy. She wanted to put a chest x-ray was done. He has Metastatic Prostate Cancer and the pain was coming from the lesions on his lung and rib. Caller explained the Chest X-Ray showed the mets (metastasis) but no new lesions, no infiltrates or anything. It showed nothing related to the COVID-19 vaccine.The patient underwent lab tests and procedures which included Chest X-ray: showed the mets (metastasis) but no new lesions, no infiltrates or anything on 29Jan2021 and EKG: essentially normal on 29Jan2021. The outcome of the events disorientated, in a lot of pain in his chest and rib area, hurt to breathe, shaken up and move and short of breath/it hurt to breathe was recovered on 30Jan2021. The reporter's assessment for all the events was related.; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to all events disorientation, chest pain, musculoskeletal chest pain, movement disorder, shaking, and shortness of breath cannot be excluded. The ongoing prostate cancer metastatic status and immunotherapy may be major cofounders. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,OTH,ZYTIGA; PREDNISONE,Prostate cancer metastatic (Diagnosed a few years ago),Medical History/Concurrent Conditions: Immunomodulatory therapy,,,"['Chest X-ray', 'Chest pain', 'Disorientation', 'Dyspnoea', 'Electrocardiogram', 'Movement disorder', 'Musculoskeletal chest pain', 'Off label use', 'Product use issue', 'Tremor']",1,PFIZER\BIONTECH,OT 1034998,HI,63.0,F,"colitis flare up/soft stools and abdominal pains; my joints were aching: ankles, hips, elbows, shoulders, wrist.; Also my allergies seemed to be bothering me more; This is a spontaneous report from a contactable other healthcare professional (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:EJ1686), via an unspecified route of administration into the right arm on 11Jan2021 08:30 at a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, osteoporosis, ulcerative colitis, ongoing colitis and ongoing allergies to mites, mold, pollen, environmental and rubber. Patient was not pregnant. Concomitant medication included venlafaxine (VENLAFAXINE), zolpidem (ZOLPIDEM) and levothyroxine (LEVOTHYROXINE). The patient was previously administered with first dose of zoster vaccine recombinant, adjuvanted (SHINGRIX) via an unspecified route of administration into the right arm on 04Dec2020 for immunization. On 12Jan2021, the patient's allergies seemed to be bothering her more. On 13Jan2021 09:00, patient woke up with her joints aching: ankles, hips, elbows, shoulders and wrist. On 14Jan2021, patient experienced colitis flare up with soft stools and abdominal pains. The patient did not receive treatment for the events reported. Outcome of events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/12/2021,1.0,PVT,VENLAFAXINE; ZOLPIDEM; LEVOTHYROXINE,Allergy to molds; Colitis; Environmental allergy; Latex allergy; Mite allergy; Pollen allergy,Medical History/Concurrent Conditions: Osteoporosis; Rheumatoid arthritis; Ulcerative colitis,,,"['Arthralgia', 'Colitis', 'Hypersensitivity']",1,PFIZER\BIONTECH, 1034999,NY,45.0,F,"injection site pain; chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); shortness of breath; fatigue; This is a spontaneous report from a contactable consumer reporting for herself. This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247 and expiry date unknown) on 16Jan2021 at 11:00 via an unspecified route of administration into right arm at a single dose for COVID-19 immunization. The patient had known allergies to penicillin, erythromycin, garlic. Other medical history included asthma. She was not pregnant. The patient had not had COVID prior to the vaccination. Nasal Swab (for COVID) tested on 19Jan2021 was negative. Concomitant medications in two weeks included venlafaxine and ceirizine hydrochloride (ZYRTEC). No other vaccine received in four weeks. The patient experienced chest discomfort (fluttering, thud feeling, tightness), shortness of breath, fatigue since 17Jan2021 11:00, and injection site pain since 01Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone and formoterol fumarate;mometasone furoate (DULERA) as treatment for the adverse events. The patient had not recovered from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/17/2021,1.0,PUB,VENLAFAXINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Asthma; Penicillin allergy; Spice allergy (allergies: Garlic),,,"['Cardiac flutter', 'Chest discomfort', 'Dyspnoea', 'Fatigue', 'Palpitations', 'SARS-CoV-2 test', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1035000,NJ,62.0,F,"16% loss of hearing; Fullness in ear on the injection side (left); This is a spontaneous report from a contactable consumer. A 62-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 13Jan2021 at 11:30 at a single dose on left arm for COVID-19 immunisation. Medical history included breast cancer, lymphedema (right arm) and asthma from an unknown date and unknown if ongoing. Concomitant medications included montelukast sodium (SINGULAIR). The patient experienced 16% loss of hearing and fullness in ear on the injection side (left) on 14Jan2021 at 17:00. The patient underwent lab tests and procedures which included acoustic stimulation tests: 16 % (16% loss of hearing) on 14Jan2021. Therapeutic measures were taken as a result of 16% loss of hearing and fullness in ear on the injection side (left). The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,PVT,SINGULAIR,,Medical History/Concurrent Conditions: Asthma; Breast cancer; Lymphedema,,,"['Acoustic stimulation tests', 'Deafness', 'Ear discomfort']",1,PFIZER\BIONTECH, 1035001,MI,40.0,F,"mild case of Bell's Palsy.; skin of the patient's jaw and chin started to feel numb/numbness of her cheeks, eyebrows, and ears; headache; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021) via intramuscular in the upper left arm on 01Feb2021 at 04:30 PM at single dose for COVID-19 immunization. Medical history included asthma (exercise induced) and menstruating. Concomitant medications included Ibuprofen because she was menstruating. No other vaccine in four weeks. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021) via intramuscular in the upper right arm on 11Jan2021 at 04:30 PM at single dose for COVID-19 immunization. The patient was not pregnant. The skin of the patient's jaw and chin started to feel numb about 20 minutes after receiving the vaccine, headache came and went rapidly on 01Feb2021 17: 00. The sensation progressed rapidly to include numbness of her cheeks, eyebrows, and ears. The symptoms appeared rapidly after leaving the clinic as the patient was driving away on her from work. Both sides of her face were impacted equally. She went to an urgent care facility to be evaluated. An Urgent Care Physician's Assistant evaluated the patient. They looked inside her throat to see if it was closing up (it wasn't). They used a swab to test her sensory ability on her face by pressing with either the fuzzy-side or the blunt (wooden) side. When the patient asked the PA how she did, she indicated that she failed the test. They gave her Benadryl. At home, the patient went to bed, woke up normally, and did a ""frown test"" in front of the mirror. Her left side of face wasn't working the same way as the right side. She may have a mild case of Bell's Palsy in the morning of 02Feb2021. The patient had no covid prior vaccination, no covid tested post vaccination. Benadryl was received as treatment for the events. Outcome of the event ""skin of the patient's jaw and chin started to feel numb/numbness of her cheeks, eyebrows, and ears"" and ""mild case of Bell's Palsy"" was recovering, of the event ""headache"" was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,WRK,IBUPROFEN,,Medical History/Concurrent Conditions: Asthma exercise induced; Menstrual cramp,,,"['Facial paralysis', 'Headache', 'Hypoaesthesia']",2,PFIZER\BIONTECH,OT 1035002,MA,39.0,F,"jaw spasms on the left side of face near TMJ; Involuntary jaw closing; This is a spontaneous report from a contactable consumer (patient) reported that a 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the right arm on 29Jan2021 17:45 at a single dose for covid-19 immunization. The vaccine was administered at the Health Department. The patient also received the first dose of other vaccine (reported as Pfizer brand) via an unspecified route of administration on the right arm on 29Jan2021. Medical history included tinnitus from an unknown date, and allergy from quinoa. Patient is not pregnant at the time of the vaccination. Concomitant medications included ergocalciferol (VIT D), and fexofenadine hydrochloride (ALLEGRA). The patient previously took, neosporin [neomycin sulfate;polymyxin b sulfate] and experienced drug allergy. On 02Feb2021 08:00, the patient experienced jaw spasms on the left side of face near TMJ, and involuntary jaw closing when teeth were very close to each other. The reported events was resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/02/2021,4.0,PUB,VIT D; ALLEGRA,,Medical History/Concurrent Conditions: Allergy to grains; Tinnitus,,,"['Jaw disorder', 'Trismus']",1,PFIZER\BIONTECH, 1035003,NV,74.0,F,"Atrial fibrillation; This is a spontaneous report from a contactable consumer (reported for herself). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN5318; expiry date: not known), via an unspecified route of administration in the left arm on 01Feb2021 10:45 at single dose for COVID-19 immunization. Medical history included deep vein thrombosis (DVT) and allergies to sulfa drugs. The patient's concomitant medications were not reported. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient previously took amoxicillin, clavulanate potassium (AUGMENTIN) and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced atrial fibrillation on 01Feb2021 17:45. No treatment received for this event. The outcome of the event was recovered on an unspecified date in Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,PUB,,,Medical History/Concurrent Conditions: DVT; Sulfonamide allergy,,,['Atrial fibrillation'],1,PFIZER\BIONTECH, 1035004,MN,36.0,F,"sensation change (pins and needles) in left arm; Tested positive for COVID 23Jan2021/headache; Tested positive for COVID 23Jan2021/headache; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via intramuscular on 05Jan2021 13:00 at single dose in right arm for COVID-19 immunisation. Medical history included known allergies: coconut. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient was tested positive for COVID (test name was reported as COVID-19/SARS COV2, PCR (COVOO)) on 23Jan2021. Patient was asymptomatic at the time and was tested due to positive household members. Patient developed symptom (headache) on 25Jan2021. Patient developed sensation change (pins and needles) in left arm on 31Jan2021. Patient was seen in Emergency Room and kept overnight for observation. No obvious cause for symptoms was found. No treatment was received for the events. Outcome of the events was reported as resolving. This case was reported as serious with seriousness criteria: caused/prolonged hospitalization.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/05/2021,01/23/2021,18.0,PVT,,,Medical History/Concurrent Conditions: Food allergy,,,"['COVID-19', 'Drug ineffective', 'Paraesthesia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1035005,TX,69.0,F,"Took 1st shot and got anxious; a lot of fatigue; felt something in her chest area/chest feeling funny; Head spinning; Weakness; nerve pain; stomach nausea; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date: unknown), via an unspecified route of administration, in the right arm, on 16Jan2021 14:15 at a single dose for covid-19 immunization. Medical history included left-sided breast cancer from 2005 and lymph nodes removed on her left side. Concomitant medications included pravastatin and a lot of vitamins. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccine administered on same date of the Pfizer suspect. It was reported that the patient took first shot and got anxious on 16Jan2021. The patient also experienced a lot of fatigue on 16Jan2021, went home and got worse then was hospitalized. The patient had a virtual visit with her doctor and wanted some advice, and her doctor didn't give her any prescriptions. The patient also felt something in her chest area on 16Jan2021, after receiving the COVID-19 vaccine. Events anxious and fatigue required emergency room visit. The patient was hospitalized from 25Jan2021 to 27Jan2021 for the events anxious and fatigue. The patient also experienced head spinning, chest feeling funny, weakness and stomach nausea on unspecified date in Jan2021. Reported she was given all kinds of medicine in the hospital. She said as long as she was laying down, she was good. She said once she got up, and moved around, she felt the weakness again. She said she was put on depression medicine (Jan2021) while in the hospital, and was given 4 different prescriptions at discharge. She said the only thing that helps her go to sleep at night is a 1/2 tablet of generic alprazolam for anxiety. She said she knows she can't stay on the generic alprazolam forever, clarifying that is why the doctor put her on the depression medicine. Reported she was given the following medications in the hospital, as well as, prescriptions to continue the medications at home after her hospital discharge: escitalopram 10mg for depression. She said she is to take one escitalopram 10mg every evening for 30 days. She said she was given escitalopram 10mg for the two days she was in the hospital. Generic gabapentin 100mg for nerve pain (Jan2021) and she is to take 1 capsule nightly for 30 days. She said she started the gabapentin 100mg while she was in the hospital. Pantoprazole 40mg, she was given a one-time small IV bag of pantoprazole 40mg for her stomach while she was in the hospital (clarified she was given on 27Jan2021 at 05:26). She said she was having some stomach nausea (Jan2021), and the pantoprazole 40mg was to protect her stomach. She said she told the doctor she didn't want to take the pantoprazole 40mg any longer because she thought she was being given too many different medicines. Reported her fatigue is not the same as it was when she went to the hospital, but the fatigue is still there. Reported her lab work (Jan2021) was good, and her test results were fine when she was in the hospital. She said she was told she was 30% from being on the verge of having heart disease. She said her doctor told her the heart disease was preventable if she eats right, and makes some other changes. She said her cholesterol has gone done. She said she just has the fatigue, and that was why she was put on medicine. Therapeutic measures were taken as a result of the event anxious, fatigue, nerve pain and stomach nausea. Outcome of the event fatigue was recovering while it was unknown for all the other events.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/16/2021,01/01/2021,,PVT,PRAVASTATIN,,Medical History/Concurrent Conditions: Breast cancer; Lymph node excision,,,"['Anxiety', 'Asthenia', 'Blood cholesterol', 'Chest discomfort', 'Fatigue', 'Investigation', 'Nausea', 'Neuralgia', 'Vertigo']",1,PFIZER\BIONTECH, 1035006,NC,74.0,F,"Passed out and fell to the floor before daylight; Passed out and fell to the floor before daylight; Dizziness; This is a spontaneous report from a contactable consumer (patient's spouse). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265) on 01Feb2021 at 13:15 at single dose intramuscular COVID-19 immunization. Relevant medical history included Alzheimer's disease diagnosed about 5-6 years ago, seizure (diagnosed 40 years ago) and ongoing high blood pressure. Concomitant medications were not reported. On 02Feb2021 patient passed out and fell before daylight morning, it may be around 06:00-07:00 (as reported). Patient's spouse informed that got up early and was already up when she called him to tell him she had fallen. She sleeps a lot anyway, so she was just put back to bed. Reporter didn't known exactly when she was up again. It was also informed that several of the medications that she took have side effects like dizziness (as reported). At the time of the reporting event outcome was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/02/2021,1.0,OTH,,Blood pressure abnormal,Medical History/Concurrent Conditions: Alzheimer's disease (diagnosed about 5-6 years ago); Seizures (diagnosed 40 years ago),,,"['Dizziness', 'Fall', 'Loss of consciousness']",UNK,PFIZER\BIONTECH,OT 1035007,FL,67.0,F,"Face was swollen; Eyes and then my mouth and lips started swelling; Eyes and then my mouth and lips started swelling; Eyes and then my mouth and lips started swelling; Itching around my neck ears and eyes; Itching around my neck ears and eyes; Itching around my neck ears and eyes; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiry date unknown), via an unspecified route of administration on 28Jan2021 14:00 at a single dose in the left arm for COVID-19 immunisation. Medical history included multiple sclerosis and environmental allerges. Concomitant medications included ascorbic acid (VIT C), colecalciferol (VIT D3), zinc, acetylcysteine (NAC), montelukast, and other unspecified medications. Patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of bnt162b2 (brand: Pfizer, lot number: EL3246) on 07Jan2021 11:00 on the left arm. After the first dose, the patient formed a sty on her right eye and it is still there three weeks later. After second dose, the patient started itching around her neck, ears, and eyes on the day after injection, on 29Jan2021 10:00. By the third day, on 30Jan2021, when she woke up, her face was swollen, especially eyes and then her mouth and lips started swelling and the itching worsened. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient recovered from the events on an unspecified date. Treatment received for the adverse events was Depo-Medrol Injection. The events were reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/29/2021,1.0,UNK,VIT C; VIT D3; ZINC; NAC [ACETYLCYSTEINE]; MONTELUKAST,,Medical History/Concurrent Conditions: Environmental allergy; MS,,,"['Ear pruritus', 'Eye pruritus', 'Eye swelling', 'Lip swelling', 'Mouth swelling', 'Pruritus', 'Swelling face']",2,PFIZER\BIONTECH, 1035008,AZ,26.0,F,"Syncope; Passed out within minutes of second dose.; Urination and emesis upon waking up; Urination and emesis upon waking up; This is a spontaneous report from a contactable Pharmacist (patient). A 26-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 26-year-old) on 17Jan2021 at 09:30 AM as a single dose for COVID-19 immunisation, lot number: EL1283. Medical history was not provided. Patient had no known allergies. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Dec2020 at 09:30 AM via an unspecified route of administration in Left arm (at age of 26-year-old) for COVID-19 immunisation, lot number: EH9899. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 17Jan2021 at 09:45 AM patient experienced syncope. Passed out within minutes of second dose. Urination and emesis upon waking up. Brought to hospital, given 1L nacl and 1 dose of ondansetron (ZOFRAN). Events considered serious due to hospitalization. Events resulted in Emergency room/ department or urgent care. Patient was treated with fluids and ondansetron (ZOFRAN). Patient was not tested for Covid post vaccination. Patient recovered from the events on unknown date.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/17/2021,01/17/2021,0.0,UNK,,,,,,"['Loss of consciousness', 'Micturition disorder', 'Syncope', 'Vomiting']",2,PFIZER\BIONTECH, 1035009,MN,28.0,F,"embryonic demise/loss of pregnancy; patient was pregnant at the time of vaccination of the second dose; patient was pregnant at the time of vaccination of the second dose; This is a spontaneous report from a contactable healthcare professional. A 28-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284), intramuscular in the left arm on 12Jan2021 at 08:00 at a single dose, received in the Doctor's office/urgent care for covid-19 immunisation. Medical history included anxiety and allergies: gets hives from anything cold (fluid, food, air) that touches her. Concomitant medication included venlafaxine for anxiety. The patient was pregnant at the time of vaccination of the second dose, last menstrual date was 23Nov2020, delivery date was 30Aug2021, gestation period was 7 weeks. The patient experienced embryonic demise/loss of pregnancy in Jan2021, patient was hospitalized for 1 day and treatment was received for the event. The patient underwent lab tests and procedures which included didn't see a fetal heartbeat at 6 week on u/s, and 7 weeks still no heartbeat on u/s, HCG didn't go down until second u/s, so fetal demise occurred between 6 -7 weeks, D&C performed and no genetic abnormalities were found in fetal tissue. Doctor and patient, who is a nurse, do not think the fetal demise is related to the vaccine, but wanted to document the loss for data in case they would start to see a trend. The patient does not intend to pursue further investigation into the vaccine as a cause. After the first dose (received on 21Dec2020 at 08:00, the patient had a sore arm and then two days later found out she was pregnant. The doctor discussed with patient and pharmacist whether to get second dose. Patient is a nurse and decided to get second dose. No major symptoms were reported after second dose until the miscarriage. The patient recovered from the event with lasting effects/sequel.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/12/2021,01/01/2021,,OTH,VENLAFAXINE,,"Medical History/Concurrent Conditions: Anxiety; Cold urticaria (gets hives from anything cold (fluid, food, air) that touches her)",,,"['Foetal death', 'Heart rate', 'Human chorionic gonadotropin', 'Off label use', 'Product use issue', 'Uterine dilation and curettage']",2,PFIZER\BIONTECH,OT 1035010,OH,45.0,F,"Fainting; shortness of breath; hand spasms; nausea; vomiting; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 45-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 45-year-old) on 13Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included penicillin allergy. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 16Jan2021 at 06:00 PM patient experienced nausea, vomiting, shortness of breath, fainting and hand spasms. Events resulted in Emergency room/department or urgent care. Patient was treated at emergency room (ER) with diphenhydramine hydrochloride (BENADRYL), Steroid and Anti nausea. Patient was not tested for Covid post vaccination. Patient recovered on unknown date in 2021 from the reported events.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/16/2021,3.0,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Dyspnoea', 'Muscle spasms', 'Nausea', 'Syncope', 'Vomiting']",1,PFIZER\BIONTECH, 1035011,WA,73.0,M,"a loss of vision in left eye that lasted for about three minutes; Dizzy sell; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration on 12Jan2021 08:15 at single dose in left arm for COVID-19 immunisation. Medical history included had surgery for a torn rotator cuff on 07Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) only at night a few days before taking the shot for post-operative pain control. Two days after BNT162B2 (14Jan2021 14:00), patient had a loss of vision in left eye that lasted for about three minutes and had a dizzy sell that lasted for forty-five minutes after getting out of the hot tub. It was unknown if treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. Doctors had no explanation at this time and had no idea if it was related to the injection. Outcome of the events was resolved on 14Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/14/2021,2.0,PVT,PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL],,Medical History/Concurrent Conditions: Rotator cuff repair,,,"['Blindness transient', 'Dizziness']",1,PFIZER\BIONTECH, 1035012,PA,35.0,F,"4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; 4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; 4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; This is a spontaneous report from a contactable nurse (reporting for herself). A 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3302), at age 35 years, via an unspecified route of administration on the left arm, second dose on 29Jan2021, at single dose, for COVID-19 immunization. Medical history included breast feeding from an unknown date and unknown if ongoing, and COVID-19 on unspecified dates diagnosed prior to vaccination. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient previously took BNT162B2 on 08Jan2021 at age 35 years for COVID-19 immunization. On 02Feb2021, 4 days after the second dose, the patient experienced dizziness, nausea and was diagnosed with vertigo when seen in ER. The adverse event resulted in emergency room/department or urgent care visit. Treatment received for the adverse event includes IV fluids and meclizine. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a hospital. The outcome of the event was recovering/resolving. Case was reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/02/2021,4.0,PVT,,,Medical History/Concurrent Conditions: Breast feeding; COVID-19,,,"['Dizziness', 'Nausea', 'Vertigo']",2,PFIZER\BIONTECH, 1035013,MI,73.0,M,"has an autoimmune disease/Myasthenia gravis and was given bnt162b2 vaccine; has an autoimmune disease/Myasthenia gravis and was given bnt162b2 vaccine; General feeling of malaise; Prickly feeling through body; General Flu-type feeling; Fever of 101 degrees; This is a spontaneous report from a contactable other healthcare professional (patient). A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9251), via an unspecified route of administration on 20Jan2021 07:00 at 0.3 mL, single on left arm to prevent COVID virus (COVID-19 immunization). Medical history included myasthenia gravis, and an ongoing autoimmune disorder. Patient has no family medical history. There were no concomitant medications. The patient did not receive any other vaccines 4 weeks prior to COVID vaccination. The patient did not receive additional vaccines on the same date as Pfizer suspect. On 20Jan2021, the patient experienced general feeling of malaise, prickly feeling through his body, which lasted a few hours and fever of 101 degrees. On the same day (20Jan2021), patient had general flu-type feeling that lasted the whole day. He was fine the next morning (21Jan2021), when he woke up. The events were considered serious and medically significant by the reporter. The events did not require a visit to a physician or to an emergency room. The patient underwent Gammunoglobulin blood test with unknown results on an unspecified date. The patient recovered from general malaise, prickly feeling through the body, general flu-type feeling, and fever of 101 degrees on 21Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/20/2021,0.0,PVT,,Autoimmune disorder,Medical History/Concurrent Conditions: Myasthenia gravis,,,"['Body temperature', 'Immunoglobulins', 'Influenza like illness', 'Malaise', 'Off label use', 'Paraesthesia', 'Product use issue', 'Pyrexia']",1,PFIZER\BIONTECH, 1035505,,,U,"Passed away with an hour to hour and 1/2 of receiving vaccine; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed away with an hour to hour and 1/2 of receiving vaccine. The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient passed away within an hour and a 1/2 of receiving the vaccine. Per the nursing home staff, they did not expect the patient to make it many more days. The patient was unresponsive in the room when the shot was given. The patient was 14+ days post COVID. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on an unknown date. The cause of death was unknown.; Reporter's Comments: This case concerns a patient, who experienced event of death (unknown cause). The event occurred an hour to hour and 1/2 after the first and last dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related. However, Per the nursing home staff, the patient was 14+ days post COVID and they did not expect the patient to make it many more days. The patient was unresponsive in the room when the shot was given.; Reported Cause(s) of Death: unknown cause of death",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,['Death'],1,MODERNA,OT 1035506,ID,37.0,F,"Temperature was 102 F; Lips turned blue; Wheezing; Heart rate was elevated to 105-112 bpm; A spontaneous report was received from a dentist, a 37-year old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced heart rate was elevated to 105-112 bpm, wheezing, lips turned blue, and temperature was 102 F. The patient's medical history, as provided by the reporter, included monk fruit allergy and high blood pressure. Concomitant medications reported included hydrochlorothiazide. On an unknown date, the patient received their first of two planned doses of mRNA-1273. On 28 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 28 Jan 2021, following vaccination, the patient experienced an elevated heart rate of 105-112 beats per minute (bpm). The patient stated that 80 bpm was normal for her. At 7:30 pm, she began wheezing and her lips turned blue, both of which resolved within 2 hours. The patient took ibuprofen, naproxen, and diphenhydramine and sat in a warm tub for an hour and felt better after she covered up in bed. On 29 Jan 2021, the patient's temperature was 102 degrees Fahrenheit (F) at midnight and 99 degrees F at 5:00 am. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The events, wheezing and lips turned blue, were considered resolved on 28 Jan 2021. The outcome of the events, heart rate was elevated to 105-112 bpm and temperature was 102, was unknown.; Reporter's Comments: This case concerns a 37-year-old, female patient, with medical history of high blood pressure and allergies to monk fruit, who experienced serious unexpected event of cyanosis, non-serious unexpected event of wheezing, heart rate increased, and non-serious expected event of pyrexia. The event of cyanosis, wheezing, heart rate increased occurred 1 day (same day) and fever occurred 2 days after mRNA-1273 (Lot# 030L20A). Treatment included Ibuprofen, Benadryl and Naprosyn. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,HYDROCHLOROTHIAZIDE,Fruit allergy (Monk fruit); Hypertension,,,,"['Body temperature', 'Cyanosis', 'Heart rate', 'Heart rate increased', 'Pyrexia', 'Wheezing']",1,MODERNA,OT 1035507,WA,,F,"3 episodes of fainting; Flu like symptoms; Chest tightness; Sore and tender upon swallowing food; Muscle aches on right arm; fever; fatigue; A spontaneous report was received from a consumer concerning a 45-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fatigue, fever, fainting, muscle aches, flu-like symptoms, chest tightness, and sore throat. The patient's medical history, as provided by the reporter, included childhood asthma and seasonal allergies. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 on an unknown date. On 28 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (042L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient had fatigue by the end of the day following vaccination. On 29 Jan 2021, the patient presented fever and 3 episodes of fainting. She had muscles aches on her right arm, flu-like symptoms, chest tightness, and sore/tender throat area upon swallowing food. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable. The outcome of the events was not reported.; Reporter's Comments: Further information has been requested as there is limited information regarding the events, particularly the event of syncope and chest discomfort. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/28/2021,0.0,UNK,,Seasonal allergy,Medical History/Concurrent Conditions: Childhood asthma,,,"['Chest discomfort', 'Fatigue', 'Influenza like illness', 'Myalgia', 'Odynophagia', 'Pyrexia', 'Syncope']",2,MODERNA,OT 1035508,FL,64.0,F,"Platelet count of 28,000; Generalized body pain all over; Weakness; On and off Chills; Low grade fever; Injection site soreness; A spontaneous report was received from a consumer who was a 64-year-old, female patient who developed a platelet count of 28,000 (thrombocytopenia), generalized body pain all over (general body pain), weakness (asthenia), on and off chills (chills), low grade fever (pyrexia), and vaccination site soreness (injection site pain). The patient's medical history was not provided. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (lot number 039K20A) on 31 Dec 2020. On 28 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (lot number 209K20A) in the left arm for prophylaxis of COVID-19 infection. On an undisclosed date the patient experienced injection site soreness, generalized body pain all over, chills, low grade fever and weakness. She also went to the hospital because she had a platelet count of 28,000. Treatment of these events was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable. The outcome of the events, platelet count of 28,000, generalized body pain all over, weakness, on and off chills, low grade fever, and vaccination site soreness, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,12/31/2020,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Asthenia', 'Chills', 'Pain', 'Pyrexia', 'Thrombocytopenia', 'Vaccination site pain']",2,MODERNA,OT 1035509,AR,38.0,F,"Throat closing; Swelling of throat; Lip swollen; Shortness of breath; Tachycardia; Swelling of face; A spontaneous report was received from a healthcare professional concerning a 38-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat closing, swelling of the face and throat, shortness of breath, tachycardia and lip swollen. The patient's medical history was not provided. Concomitant product use was not reported. On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 12 Jan 2021, one day after vaccine administration, the patient was sent to the hospital by ambulance after her throat closed. She had swelling of face and throat, shortness of breath and tachycardia. In the ambulance, diphenhydramine, methylprednisolone, and famotidine were administered. She was discharged four hours later with prednisone, diphenhydramine, epinephrine, famotidine, and loratadine. On 15 Jan 2021, the patient was still having daily flare ups of a swollen lip and throat closing. Action taken with mRNA-1273 in response to the events was not reported. The events, throat closing and lip swollen, were considered not resolved. The outcome of the events, swelling of the face and throat, shortness of breath, and tachycardia, was unknown.; Reporter's Comments: This spontaneous report concerns a 38-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat closing, swelling of the face, shortness of breath, tachycardia and lip swollen. The events occurred 1 day after the administration of mRNA-1273 vaccine (Lot number: 041L20A, expiration date: unknown). Treatment provided include diphenhydramine, methylprednisolone and famotidine and outcome is unknown for swelling of the face, shortness of breath and tachycardia. Throat closing and lip swollen are not resolved. Based on the information provided which shows a temporal association, a causal association between the reported events and the administration of mRNA-1273 vaccine cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/12/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No adverse event history),,,"['Dyspnoea', 'Lip swelling', 'Pharyngeal swelling', 'Swelling face', 'Tachycardia', 'Throat tightness']",1,MODERNA,OT 1035513,MI,,F,"kidney stones; blood in her urine; sore arm; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer, reporting for herself. A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took glipizide for diabetes and experienced bruising and bleeding. About three years ago, the patient took Glipizide ER for about 3 months (dose unknown but she was splitting the tablets and taking small amount) and noted an increased incidence of bruising which was worsening over time and longer bleeding because of it. She had blood work done and results came back within normal limits, including platelets. She discontinued the glipizide ER. The patient currently has kidney stones that can shift around and cause blood in her urine which occurred on an unspecified date in Jan2021, about 3 days after the first Pfizer COVID vaccine. After receiving this first vaccine, she had a sore arm, but no bleeding or bruising. The patient underwent lab tests and procedures which included blood work: within normal limits, including platelets on an unspecified date. The outcome of the events was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/01/2021,,UNK,,,,,,"['Blood test', 'Blood urine present', 'Nephrolithiasis', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1035514,,,U,"feelings of fainting; high blood pressure in the 160s, normally <120s systolic); severe headaches; dizziness; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (Lot number and expiry date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history concomitant medications were not reported. On an unspecified date, the patient developed severe headaches, dizziness, high blood pressure (in the 160s, normally <120s systolic), and feelings of fainting 5-10 minutes after receiving the first dose of the vaccine. This adverse event was reported already, but the pharmacist was wondering if it is still recommended to get the second dose after a reaction like this. Stated ""This reaction doesn't meet your definition of anaphylaxis or allergic reaction which is why I am reaching out to see if you have any recommendations on this"". The patient underwent lab tests and procedures which included blood pressure: high blood pressure (in the 160s, normally <120s systolic). The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Blood pressure measurement', 'Dizziness', 'Headache', 'Hypertension', 'Syncope']",1,PFIZER\BIONTECH, 1035515,MD,61.0,F,"almost like she also had some mild hearing loss; nausea; exacerbation of migraine with paresthesia and tinnitus/ headaches/migraines; exacerbation of migraine with paresthesia and tinnitus; exacerbation of migraine with paresthesia and tinnitus/ increased tinnitus; some abdominal tightness; This is a spontaneous report from a contactable pharmacist (patient herself) via Medical Information team. A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3302, NDC number/expiration date was unknown), via an unspecified route of administration on the left arm (also reported as upper left arm) on 13Jan2021 at 09:00 at a single dose for COVID-19 immunization; the patient was a healthcare worker and was trying to protect herself. The vaccination facility type was reported as a drive thru site. Relevant medical history included previous neurological problems, which included history of underlying migraine with paresthesia/chronic paresthesia (ongoing) and tinnitus. The patient had no family medical history relevant to the adverse events (AEs). There were no concomitant medications. The patient had no other vaccine received on the same day of the Pfizer suspect or 4 weeks prior. She never had any problems with vaccines in the past. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Initially, the patient was asking if there were any reports of paresthesia, serious neurologic adverse events, tinnitus, hearing loss, or abdominal tightness in the studies for the Pfizer-Biontech Covid-19 vaccine. After the patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 13Jan2021, she experienced an exacerbation of migraine with paresthesia and tinnitus. She also reported experiencing some abdominal tightness on an unspecified date in Jan2021. The patient reported she was scheduled for her second dose of the Pfizer COVID-19 vaccine, but had concerns because she was still experiencing tinnitus and it was ""almost like she also had some mild hearing loss"" on an unspecified date. The patient further reported that she was due for the next dose the following day at the time of the report (03Feb2021). She had previous neurological problems and did not know if this did exacerbate things or not. She had migraines, tinnitus, and paresthesia and was wondering how many other patients with neurological problems reported this and was this a common side effect or adverse event reported. One doctor told her not to get the second dose and another one told her to get it and she wanted to know what she should do. The patient had headaches/migraines on the evening of vaccination on 13Jan2021 that were fairly mild and 3 days after that on 16Jan2021, they got bad and was accompanied with nausea with increased tinnitus. The migraines and nausea had gone, and the chronic paresthesia was the same as she always had, but the tinnitus was a lot louder and worse. The patient also mentioned that her migraines usually go away, but this one had lingered. The AEs did not require any visit to an emergency room or a physician office. There were no investigation assessment. The patient recovered from the event ""nausea"" on an unspecified date, she was recovering from the event ""exacerbation of migraine/ headaches/migraines,"" she was not recovered from the events ""exacerbation of paresthesia and tinnitus/increased tinnitus, while the outcome of the events ""almost like she also had some mild hearing loss and some abdominal tightness"" was unknown. The reporter assessed the events ""migraine, tinnitus, paresthesia, and nausea"" as serious, other medically important conditions. The relatedness of drug to the reactions/events ""migraine, tinnitus, paresthesia, and nausea"" was unknown as per the reporting pharmacist (Method of assessment: Global Introspection).; Sender's Comments: The 61-year-old female had relevant medical history included previous neurological problems. The reported neurological events and partial hearing loss were more likely due to pre-existing conditions, and less likely related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Event nausea was likely due to the first dose of bnt162b2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/01/2021,,UNK,,Paresthesia (history of underlying migraine with paresthesia/chronic paresthesia and tinnitus),Medical History/Concurrent Conditions: Migraine (history of underlying migraine with paresthesia/chronic paresthesia and tinnitus); Neurological impairment; Tinnitus (history of underlying migraine with paresthesia/chronic paresthesia and tinnitus),,,"['Abdominal rigidity', 'Hypoacusis', 'Migraine', 'Nausea', 'Paraesthesia', 'Tinnitus']",1,PFIZER\BIONTECH, 1035516,NC,48.0,F,"Dysgeusia; Left hemicranial numbness/ Mild residual numbness left face; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231, expiry: unknown), intramuscular in the left arm on 06Jan2021 14:30 at a single dose for covid-19 immunization at a clinic. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had no other medications received within 2 weeks of vaccination. On 06Jan2021 at 15:00, the patient experienced dysgeusia 20 min after exam lasting 1 min and left hemicranial numbness times 24 hrs. The patient still has mild residual numbness on left face. The events resulted in doctor or other healthcare professional office/clinic visit. The events were not treated. Prior to vaccination, the was not patient diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the events dysgeusia and numbness with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,OTH,,,,,,"['Dysgeusia', 'Hypoaesthesia', 'Investigation']",1,PFIZER\BIONTECH,OT 1035517,VA,73.0,F,"psychedelic feeling; horrible palsy, as if her muscle was being pulled like a rubber band; horrible palsy, as if her muscle was being pulled like a rubber band; the worse bowel movement. She had to go the bathroom a lot; Her right arm was the worse with the pain and then her hands would kind of move in a kind of crazy way where it was tightening; muscle cramping and pulling; Her toes would contort and go backwards.; she feels like the left arm is going to do something, its like the last to be pulled; shingles; muscles became tight/contort; minor nausea; Stomach cramps; Gas; Indigestion; became weird in her head, almost like a lightheadedness; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular on 30Jan2021 at 10:00 at a single dose on right arm for COVID-19 immunisation. Medical history included fever, being ill (deathly ill and it lasted for three weeks) and bug bites from an unknown date and unknown if ongoing. There were no concomitant medications. The patient is the type of person that takes a lot for her to take medications. She is allergic to a lot of things; she always has crazy reactions. She can't take morphine. It took her 7 pills to get the right one for high blood pressure. She has the craziest one-day reactions. She received the COVID-19 vaccine on Saturday much against her will, knowing she had COVID but not diagnosed in March. She had a fever, she was deathly ill and it lasted for three weeks. She had a nasal swab done and it came back negative. She doesn't think that was right, she believes she had COVID-19 in Mar2020. Her daughter is younger, and she had the same thing, she couldn't breathe good for 3 weeks. She had pneumonia. She knows she had COVID-19. She was trying to lose weight. She was given her first COVID-19 vaccine by a doctor. Everything was going okay at first. About an hour and a half later, she became weird in her head, almost like a lightheadedness. She can't describe it. She has never taken drugs. She doesn't drink alcohol at all. She has like a virgin body. She states plus she is red headed, which it is known red heads have a harder time with medication. As the day goes on, she just felt lightheaded all the rest of the day. The next day (Sunday, 31Jan2021), she wakes up and it hits her like a ton of bricks. She woke in the morning and seemed to be okay and then it was like she was pregnant and blew up. She started cramping really bad and had gas. Everybody has gas. She was a little nauseated as well. She experienced lots of indigestion, cramping in her stomach like she was going to have a baby or the worse bowel movement. She had to go the bathroom a lot. She had a little bit of nausea. She had nausea pills because she had a gallbladder taken out and she took nausea pills for 2-3 days. She didn't take any medication for any of these symptoms she started to experience on Sunday. However, she did start popping Gas-X. She was taking two Gas-X every 3 or 4 hours. The caller states it helped. She had lots of gas; gas was just coming out of her bottom. She had the gas, cramps, her stomach hurt. She was able to get through it, which that is good. Then Monday, 01Feb2021 was the day she had weird things happen to her that she was kind of concerned about. Her muscles started to draw, that is the best way she can describe it. Her feet would just draw up weird. Her arms and hands would do crazy things and contort or draw up. This hurts because the muscles are like a rubber band pulling. It was weird, and she didn't like it. It wasn't like when she has a horse and has to get up and stand, it wasn't like that at all. Her muscles were tightening up like a rubber band. Her right arm was the worse with the pain and then her hands would kind of move in a kind of crazy way where it was tightening. She thought to herself, ""what is this Parkinson's?"". She doesn't even know. She still has some stomach issues, but it is easing up. The gas is still coming out. It wasn't debilitating or anything. She has some minor nausea. What scared her more was the muscle cramping and pulling. Her toes would contort and go backwards. The muscle tightness occurred yesterday, 01Feb2021. It happened all day and was sporadic. Her toes moved in a different way like a rubber band pulling on muscle. Nothing has happened today. Everything was yesterday. Her whole body basically was affected, just different sections at different times. Today, she feels like the left arm is going to do something, it's like the last to be pulled. Her hands and fingers stayed the same. She explains like the upper arm area from her elbow to her shoulder part. She can't even think of what that area is, but it's the part between her elbow and shoulder. She has been doing lots of exercises and moving, hoping the part of her elbow to her should don't atrophy or won't pull. She hasn't told anybody about it. She doesn't like it. It was very frightening. She is scheduled for her second shot and she is scared to death to go back. She mentions her nerves are shot. From stress, she had previously broken out instantly. She thought it was a bug biting her. She never had gone to the doctor but after about 4 weeks, she thought she had these horrible bug bites. She was shaking her clothes and she almost wanted to strip it was so bad. She thought it was severe bug bites. She couldn't figure it out. She finally went to the doctor after a week. It was a Saturday. The doctor told her it was shingles. Explained that it itches a lot. She went on medication. She clarifies she went on acyclovir 800mg, three pills a day. She called her doctor knowing that she had shingles and how scared she is with medicine, the doctor assured her she could get the COVID-19 shot as scheduled. The medicine for shingles (acyclovir) was finished up the Friday before she received the COVID-19 vaccine. She got the shingles shot at 60 but everybody is now saying to get the new shot for shingles which she has never done obviously since she got the shingles. She plans to get the shingles shot in the summer. She is not worried about it. She took 3 pills a day and that was fine. She is fine, meaning every day she did normal things going through the whole process. She states she plans to go to the bank. She asked if anybody has reported the reaction she experienced after receiving the first dose of the Covid vaccine. She received the first dose of the vaccine last Saturday, in which within an hour and a half her ""brain got weird, like a psychedelic feeling and it felt like I was getting an injection in the operating room to go to sleep."" On Monday she experienced, ""horrible palsy, as if her muscle was being pulled like a rubber band."" Stated that it wasn't a horse feeling. Her hands and fingers would pull and contort in different positions, in which they would remain tight and stay in that position, and then she would be able to make a closed fist. On Monday night, her left arm contorted (which is not administration arm) and her muscle became really tight from her elbow to her wrist leading to her hand contorting as well. She describes the muscle tension as if a rubber band was being pulled, it would have burst. This muscle pulling hurt, in which she took 3 ibuprofen (ADVIL). She has crazy reactions with almost anything that she takes. She has never smoked or drank. The patient underwent lab tests and procedures which included COVID-19: unknown on an unspecified date and unknown on Mar2020, SARS-COV-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of gas (flatulence), muscles became tight/contort, minor nausea, horrible palsy, as if her muscle was being pulled like a rubber band and shingles. The outcome of the event 'the worse bowel movement. She had to go the bathroom a lot' was not recovered while of the rest of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Bite; Fever; Illness (she was deathly ill and it lasted for three weeks.),,,"['Abdominal pain upper', 'Bowel movement irregularity', 'COVID-19', 'Dizziness', 'Dyspepsia', 'Flatulence', 'Foot deformity', 'Hallucination', 'Herpes zoster', 'Limb discomfort', 'Muscle discomfort', 'Muscle spasms', 'Muscle tightness', 'Nausea', 'Pain in extremity', 'Paralysis', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1035518,PA,48.0,M,"passed out; terrible headache; still some body aches; general bad feeling all over; nausea/tremendous chills and nausea; tremendous chills and nausea; low grade fever 99.5; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 48-year-old) on 02Feb2021 at 10:30 AM as a single dose for COVID-19 immunisation, lot number: EL9262. Medical history included high cholesterol and allergies to some seaweeds. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 via an unspecified route of administration in Left arm (at age of 48-year-old) for COVID-19 immunisation, lot number: EL3246. Concomitant medications in two weeks prior to the vaccination included atorvastatin and multi- vitamin. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient started about 12 hours after getting vaccinated (reported as 02Feb2021 at 10:00 PM) with a general bad feeling all over, 15 hours after (03Feb2021 at 01:00 AM) patient got out of bed because of nausea and passed out, his wife found he on the floor. Patient had tremendous chills and nausea with a low grade fever 99.5 for several more hours, maybe 6 hours, (onset date 02Feb2021) the next morning patient had a terrible headache and still some body aches. Patient was treated with extra strength paracetamol (TYLENOL) and ondansetron (ZOFRAN). Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the events, at the time of the report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,PVT,ATORVASTATIN,,Medical History/Concurrent Conditions: Food allergy (Known allergies: some seaweeds); High cholesterol,,,"['Body temperature', 'Chills', 'Feeling abnormal', 'Headache', 'Loss of consciousness', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1035519,TN,37.0,F,"At 4 Am the morning after my second vaccine I had a seizure.; I was found non responsive; blood pressure of 227/153; This is a spontaneous report from a contactable Other Health Professional (patient). A 37-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 01Feb2021 10:00 at single dose on right arm for COVID-19 immunisation. Medical history included high blood pressure. Historical vaccine included 1st dose of BNT162B2 on 11Jan2021 08:00 am via intramuscular on right arm for COVID-19 immunisation. Patient was not pregnant. Concomitant medication included labetalol and HCTZ. At 04:00 am of 02Feb2021, after second vaccine patient had a seizure. Patient was found non-responsive with a blood pressure of 227/153. Emergency room was visited. Patient have no history of seizures and it was concluded by PCP that this was an adverse response to the vaccine. Treatment was received. Outcome of the events was recovered/resolved with sequel. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events seizure, loss of consciousness and hypertension cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/02/2021,1.0,PUB,LABETALOL; HCTZ,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Blood pressure measurement', 'Hypertension', 'Loss of consciousness', 'Seizure']",2,PFIZER\BIONTECH,OT 1035520,PA,56.0,F,"tinnitus/she had 2 seconds of a very high pitch and then the following morning, she began having a low level, not high pitched, background low level type hum that was unresolved; This is a spontaneous report from a contactable pharmacist (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via intramuscular on 12Jan2021 17:30 at single dose on left arm for prevention. Medical history included hashimoto's hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID) and liothyronine sodium (CYTOMEL), both for Hashimoto's Hypothyroidism; cyanocobalamin (VIT B12), selenium, VITAMIN D3, ascorbic acid (VITAMIN C), calcium + magnesium, all for many years for vitamin supplementation. She also had a hormone replacement therapy patch that she had been taking for 5 years. She had experienced some tinnitus on 12Jan2021 21:00 and it had not resolved. She went to ENT (ear, nose and throat) for an ear exam. They were fine. They did not think it was the vaccine but did not know. After she received the vaccine, she had 2 seconds of a very high pitch and then the following morning, she began having a low level, not high pitched, background low level type hum that was unresolved. It started the evening of around 9pm. She went after work at 17:30 to get the vaccine. It was further reported that tinnitus started at 21:00 for just 2 seconds and then hearing was normal. However, the following morning, she woke up with this low level like if you leave TV on the like a hum. Very mild. This started at 06:00. No ER (Emergency Room) or physician's office required. On 29Jan2020, patient did an ear exam and hearing exam. Ear exam was perfect. Hearing exam revealed slightly hearing loss consistent with age. It was pretty normal. The part of the hearing that goes first as the age. Outcome of the event was not resolved. This case was reported as serious with seriousness criteria: medically significant.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event tinnitus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,PVT,SYNTHROID; CYTOMEL; VIT B12; SELENIUM; VITAMIN D3; VITAMIN C [ASCORBIC ACID]; CALCIUM + MAGNESIUM,,Medical History/Concurrent Conditions: Hashimoto's thyroiditis,,,"['Acoustic stimulation tests', 'Ear, nose and throat examination', 'Tinnitus']",1,PFIZER\BIONTECH,OT 1035521,TX,43.0,M,"hallucinations; drowsiness; Insomnia; extremely vivid and realistic dreams; metallic taste in mouth; muscle soreness; joint pain; headache; nausea; This is a spontaneous report from a contactable consumer reporting for self. A 43-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration on 01Feb2021 08:15 at single dose for covid-19 immunisation. Medical history included allergies to azithromycin, erythromycin, amoxicillin, penicillin. Concomitant medication included influenza vaccine inact split 4v (FLUZONE), diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL), hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). The patient experienced Insomnia, extremely vivid and realistic dreams, hallucinations 16-20 hours after injection (that night), metallic taste in mouth, muscle soreness, joint pain, headache, nausea, drowsiness for approximately 36 hours on 01Feb2021 11:00. Outcome of events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,PUB,LISINOPRIL HCTZ,,Medical History/Concurrent Conditions: Penicillin allergy (allergies: Penicillin),,,"['Abnormal dreams', 'Arthralgia', 'Dysgeusia', 'Hallucination', 'Headache', 'Insomnia', 'Myalgia', 'Nausea', 'Somnolence']",1,PFIZER\BIONTECH, 1035522,DE,75.0,M,"First time seizure occurred 12 hr after injection; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9265), via an unspecified route of administration on left arm on 30Jan2021 13:30 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. First time seizure occurred 12 hr after injection (AE resulted in: Emergency room/department or urgent care, Hospitalization for 3 days) on 31Jan2021 02:00. Therapeutic measures (LEVETIRACETAM TABLETS - (KEPPRA)) were taken as a result of event. The outcome of event was recovering.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/30/2021,01/31/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE,,,['Seizure'],1,PFIZER\BIONTECH, 1035523,,72.0,F,"vertigo; This is a report from an interventional study sponsored by BioNTech, managed and reported by Pfizer on the sponsor's behalf. The subject was in open-label phase of the study when the event occurred. A 72-year-old female subject received first and second dose of blinded therapy vaccine (BNT162; PLACEBO) on 31Aug2020 and 21Sep2020 respectively. She then received third dose of study vaccine (BNT162B2) on 13Jan2021 at 15:48 and fourth dose of study vaccine (BNT162B2) on 02Feb2021 at 11:50, both intramuscularly on left deltoid as single doses, all for COVID-19 immunization. Medical history included insomnia from 2010 and ongoing, sleep apnea from 2010 and ongoing, left knee osteoarthritis from 2014 to 2017 (with left total knee arthroplasty), osteoporosis from 2016 and ongoing and basal cell carcinoma on nose in 2018. No concomitant vaccines or prior vaccinations (within 4 weeks) were received. Family medical history relevant to the adverse event (AE) was unknown. Ongoing concomitant medications included estradiol (ESTROGEL) as hormone replacement from 2019, denosumab (PROLIA) for osteoporosis from 2017, zolpidem tartrate (AMBIEN) for insomnia from 2010; and ascorbic acid (VITAMIN C), zinc, vitamin B6, quercetin and glucosamine, all as health supplement from Mar2020. On 03Feb2021, the subject experienced vertigo with serious criteria of medically significant and hospitalization. The event required a visit to emergency room. The clinical course was as follows: Around midnight on 03Feb2021, the subject did not feel well with severe chills. She got up out of bed and went to the bathroom. She experienced vertigo, fell and hit her head. She was found bleeding by her husband who called the ambulance. She was taken to the hospital and had 7 stitches placed. She was still in the hospital at the time of the report. The action taken in response to the event for study vaccine BNT162B2 was not applicable. The outcome of event was not recovered. The investigator considered there was a reasonable possibility that the event vertigo was related to the study vaccine but not related to concomitant drugs or clinical trial procedure.; Sender's Comments: The event ""Vertigo"" is unlisted in the Single Reference Safety Document (SRSD) of the Investigational Product therapy vaccine (BNT162B2). The information provided is very limited and mainly anecdotal. Results of the diagnostic workup during hospitalization are not available. The company considers there is not a reasonable possibility that the event, vertigo, is related to vaccine administration based on the latency, the circumstances and a possible role of concomitant medication zolpidem. Pfizer's safety database was reviewed for cases reporting PF-07302048 or blinded therapy through 15-JAN-2021 for adverse events encoding to MedDRA (v.23.1J) Preferred Term(s) of Vertigo. Review of the database for the PT Vertigo had the following results: 2 serious clinical trial cases (0 of which were attributed to therapy) and 109 non clinical trial cases. The impacts of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committee and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/02/2021,02/03/2021,1.0,PVT,ESTROGEL; PROLIA; AMBIEN; VITAMIN C [ASCORBIC ACID]; ZINC; VITAMIN B6; QUERCETIN; GLUCOSAMINE,Insomnia; Osteoporosis; Sleep apnea,"Medical History/Concurrent Conditions: Basal cell carcinoma (nose); Knee arthroplasty (Left total knee arthroplasty); Knee osteoarthritis (left, left total knee arthroplasty)",,,['Vertigo'],4,PFIZER\BIONTECH,OT 1035524,TX,77.0,F,"bacteria on her stomach; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly into the right arm on 15Jan2021 at a single dose for covid-19 immunisation. Medical history included ongoing cholesterol and ongoing high blood pressure. Concomitant medication included losartan (LOSARTAN) for high blood pressure and atorvastatin (ATORVASTATIN) for cholesterol. It was reported that the patient had colonoscopy on 21Jan2021 and had found bacteria on her stomach. The patient was treated with 10 days antibiotic regimen of amoxicillin and clarithromycin. The patient's second dose was scheduled on 04Feb2021 and she was inquiring if she could still have the shot and if the antibiotic will affect the effectiveness of that shot. Outcome of event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/21/2021,6.0,UNK,LOSARTAN; ATORVASTATIN,Blood cholesterol abnormal; Blood pressure high,,,,"['Colonoscopy', 'Gastritis bacterial']",1,PFIZER\BIONTECH,OT 1035525,,,U,"kidney or urinary tract excused here; infection in urinary tract; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (30th) at single dose for covid-19 immunization. Medical history included wear hearing aids in both ears. The patient's concomitant medications were not reported. Patient found out here evidently had either a kidney or urinary tract excused here. Patient had either an infection in urinary tract. Outcome of events was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Hearing aid wearer,,,"['Kidney infection', 'Urinary tract infection']",1,PFIZER\BIONTECH, 1035527,NV,,F,"dementia; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer reported that a female patient (wife) of unspecified age was received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Calling on behalf of her wife that has dementia, she already received the 1st dose of the vaccine and was prescribed a new drug Nuplazid. Husband wanted to know the drug interaction between the two. outcome of the event was unknown. Information on batch/lot number was requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Dementia'],1,PFIZER\BIONTECH, 1035528,,,F,"stroke; couldn't speak; feeling tired; diarrhea; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a stroke (medically significant) after the first shot and couldn't speak, was feeling tired as well and diarrhea. She wanted to know if she could still take the second shot. Patient does not want to give any information. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number could not be requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Cerebrovascular accident', 'Diarrhoea', 'Fatigue', 'Speech disorder']",1,PFIZER\BIONTECH, 1035529,,,F,"ischemic stroke; This is a spontaneous report from a contactable consumer. A 9-decade-old (reported as: ""in her 80's"") female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, first dose on 28Jan2021 at single dose for COVID-19 vaccination. Recent medical history included GI complications. The patient's concomitant medications were not reported. On 01Feb2021, the patient experienced ischemic stroke requiring hospitalization. Event took place after use of product. The outcome of the event was recovering. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/28/2021,02/01/2021,4.0,UNK,,,Medical History/Concurrent Conditions: Gastrointestinal discomfort (Recent medical history of GI complications),,,['Ischaemic stroke'],1,PFIZER\BIONTECH, 1035530,GA,41.0,F,"Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; bone and muscle aches throughout body; bone and muscle aches throughout body; headaches; nausea; painful lump on under arm of the arm that the shot was given; trouble breathing; chest heaviness; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient (pregnant: unknown) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, , Formulation: Solution for injection, Lot number: unknown, expiration date unknown), via intramuscular on the left arm on 04Feb2021 at 11:30 at a single dose for COVID-19 immunization in the hospital. Medical history included diverticulosis and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient concomitant medications were not reported. The patient experienced fatigue, fever, vomiting, pain and swelling at injection site, bone and muscle aches throughout body, headaches, nausea, painful lump on under arm of the arm that the shot was given, trouble breathing, chest heaviness all on 04Feb2021 at 19:00 PM. Patient visited emergency room/department or urgent care in response to the events. Patient received Zofran, dexamethasone and espi. The reporter assessed the events as non-serious. The patient was recovering from the events. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,PVT,,,"Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination, the patient diagnosed with COVID-19); Diverticulosis",,,"['Bone pain', 'Chest discomfort', 'Dyspnoea', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vaccination site lymphadenopathy', 'Vaccination site pain', 'Vaccination site swelling', 'Vomiting']",1,PFIZER\BIONTECH,OT 1035531,NC,,F,"mild stroke; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as vaccine. Medical history and concomitant medications were not reported. On an unspecified date, the patient had a mild stroke after the 1st vaccine and she's asking if she could go early to facility for the second dose. The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Cerebrovascular accident'],1,PFIZER\BIONTECH, 1035532,FL,67.0,F,"Sty on my right eye; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL3246, via an unspecified route of administration on 07Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included multiple sclerosis (MS) and environmental allergies. Concomitant medication included ascorbic acid (VIT C), colecalciferol (VIT D3), zinc, acetylcysteine (NAC) and montelukast. In Jan2021, after 1 dose the patient formed a sty on her right eye, and it was still there three weeks later. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior vaccination the patient was not diagnosed with COVID-19 and has not been tested for COVID-19. The outcome of the event was unknown. The event was assessed as serious-medically significant.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/01/2021,,UNK,VIT C; VIT D3; ZINC; NAC [ACETYLCYSTEINE]; MONTELUKAST,,Medical History/Concurrent Conditions: Environmental allergy; MS,,,['Hordeolum'],1,PFIZER\BIONTECH, 1035533,AR,74.0,F,"she lost total hearing in one ear inside of five minutes/went totally deaf in her right ear; This is a spontaneous report from a contactable consumer reported for herself. A 74-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247 and expiry date: May2021), via an unspecified route of administration on left arm on 28Jan2021 16:00 at SINGLE DOSE for covid-19 immunisation. Medical history included chronic lymphocytic leukaemia, anaemia. The patient's concomitant medications were not reported. The patient previously took morphine and experienced drug hypersensitivity. The patient received the first dose of the Pfizer COVID 19 vaccine on 28Jan2021. On the 30Jan2021 04:00 PM, she lost total hearing in one ear inside of five minutes/she went totally deaf in her right ear. She has had tests done including a CT and MRI but she is still waiting for the results, which reported as under treatment. Adds she doesn't have an appointment yet, but she is supposed to get the next dose 18Feb2021. The event reported as serious with disability, result emergency room/department or urgent care. Outcome of the event was not recovered. Patient is not pregnant at the time of vaccination. No Covid prior vaccination. No covid tested post vaccination.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/28/2021,01/30/2021,2.0,PHM,,,Medical History/Concurrent Conditions: Anemia; CLL,,,"['Computerised tomogram', 'Deafness unilateral', 'Magnetic resonance imaging']",1,PFIZER\BIONTECH, 1035535,OK,73.0,M,"Bloody stool; Blood in urine; This is a spontaneous report from a contactable consumer reported for himself. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL8982 (reported as looks like EL8982 or 1982), on 29Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient got his COVID shot on Friday and he have no problem with the shot as far as the shot itself. On Sunday which is two days later, he had first blood in his stool when he went to the bathroom, no fever and then this morning went he urinated, at the end of the urination he has some blood there too, like that. The only adverse effect he have was bloody stool and blood in his urine. Yesterday (31Jan2021), he had no temperature, no fever stuff like that, only blood in his stool and urine, then this morning, next day, three days, blood in his urine. No Investigation Assessment. no treatment for the events. Outcome of the event was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/31/2021,2.0,UNK,,,,,,"['Blood urine present', 'Haematochezia']",UNK,PFIZER\BIONTECH, 1035536,KY,49.0,F,"Hives and it progressed to an anaphylactic reaction; Hives and it progressed to an anaphylactic reaction; hives itch; slight swelling around her eyes; This is a spontaneous report from a contactable nurse (patient) via Pfizer Sales Representative. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 at single dose for COVID-19 immunization. Medical history included anaphylaxis (Patient does have a history of anaphylaxis to bee stings), Hysterectomy, Gallbladder surgery, Mastectomy partial/ lumpectomy, Alcohol use: Yes (Comment: socially rare, Drug use: Never), Shellfish-derived products, Seasonal allergies (J30.21), HX: breast cancer (Z85.31), smoker stopped on 01Jan2000 (Former Smoker, Years since quitting: 21, Smokeless tobacco: Never Used), Hot flashes, Axillary Node Dissection. Allergie to Bee venom, Shellfish-derived products, Coconut, Codeine, and Other The patient's allergies have been reviewed. Family History included Cancer oral of Mother; Lung cancer of Father and Maternal Grandfather and Paternal Grandmother; Uterine cancer of Paternal Grandmother. Concomitant medication included ongoing cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ongoing dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]), epinephrine (EPIPEN), ongoing lisinopril dihydrate (PRINIVIL), lisinopril (ZESTRIL), ongoing metoprolol succinate (TOPROL XL), valaciclovir hydrochloride (VALTREX), zolpidem tartrate (AMBIEN) from 30Apr2020 and ongoing, promethazine (PHENERGAN [PROMETHAZINE]) from 13Sep2019. Patient previously took Codeine and had vomiting and allergy to it. Patient had an anaphylactic reaction to our vaccine. it started as hives and it progressed to an anaphylactic reaction on 08Jan2021. they gave patient Benadryl afterwards for her anaphylactic reaction because they do not want to interfere with the efficacy of the vaccine that she was able to breathe so she did not have to have any Epipen or anything. She was sent to an ER within hospital to get that. She was in the hospital getting the shot and then they sent her to the ER and she started having the reaction. Emergency department summary of care: Chief complaint: Allergic reaction. ED Diagnosis: Diagnosis Final diagnosis. Allergic reaction to vaccine: Allergic reaction to vaccine. ED Vitals: Date/Time: 08Jan2021 14:00. Pulse: 79. Resp.: 18. BP: 144/86. SpO2: 96%. Date/Time: 08Jan2021 12:54. Pulse: 90. Resp.: 16. BP: 147/98. SpO2: 96%. Weight: 72. 06 kg (160 lb). Date/Time: 08Jan2021. Temp.: 97.6 F (36.4 C). Pulse: 121. Resp.: 16. SpO2: 97%. Result: None. Imaging result: None. ECG result: None. Emergency Department Encounter: Patient was placed in face mask in first look and the following protective measures were taken unless additional measures were taken and documented below in the ED course. Patient was wearing facemask when nurse entered the room and throughout our encounter. nurse wore full protective equipment throughout this patient encounter including a face mask, and gloves. Hand hygiene was performed before donning protective equipment and after removal when leaving the room. Date of encounter: 08Jan2021. Last ED provide Note: patient is a 49 y.o. female who presents to the ED c/o chief complaint of allergic reaction. Patient reports that she just received her first Covid immunization approximately 30 minutes ago, immediately broke out into hives. Patient reports she had hives on bilateral arms as well as her back, hives itch. Patient complains of slight swelling around her eyes. No swelling of her tongue slipped or throat, no difficulty swallowing, no difficulty breathing, no nausea or vomiting. Patient reports that prior to the vaccination she was at baseline without complaint. Patient does have a history of anaphylaxis to bee stings, no other history of anaphylactic reactions, does have history of allergic reactions with hives. Patient received 50 mg oral Benadryl prior to arrival. Patient reports that the hives on her arm have since resolved, continues complain of itching on her back. No active ambulatory problem. No resolved ambulatory problem. All systems reviewed and negative except for those discussed in HPI. PHYSICAL EXAM nurse have reviewed the triage vital signs and nursing notes. ED Triage Vitals (08Jan2021 1229): Temp: 97.6 F (36.4 C), Heart Rate: 121, Resp.: 16, SpO2: 97%. General: No acute distress. HENT: NCAT, PERRL, Nares patent, no swelling of the lips tongue, no posterior oropharyngeal swelling, Voice is normal, no difficulty handling secretions Eyes: no scleral icterus. Neck: trachea midline, no ROM limitations, no stridor. CV: regular rhythm, regular rate. Respiratory: normal effort, CTAB, no wheezing rales or rhonchi Abdomen: soft, nondistended, nontender to palpation, no rebound tenderness, no guarding or rigidity. GU: deferred. Musculoskeletal; no deformity. Neuro: alert, moves all extremities, follows commands. Skin: warm, dry, bilateral arms are normal in appearance, no hives, No rash. Patient has several scattered Hives on her back. Lab Results: No results found for this or any previous visit (from the past 24 hour(s)). Nurse ordered the above labs and reviewed the results. Radiology: No Radiology Exams Resulted Within Past 24 Hours. Nurse ordered the above noted radiological studies. Nurse reviewed the images and results. Nurse agree with the radiologist interpretation. Procedures: Medications - No data to display. PROGRESS DATA. A complete history and physical exam have been performed. All available laboratory and imaging results have been reviewed by nurseself prior to disposition. After the initial H&P, Nurse discussed pertinent information from history and physical exam with patient/family. Discussed differential diagnosis. Discussed plan for ED evaluation/work up treatment. All questions answered. Patient/family is agreeable with plan. ED Course: Patient complaining of allergic reaction, hives seems to be resolving, no symptoms consistent with anaphylaxis. Symptoms seem to be improving after oral Benadryl, no further medication at this time, will monitor closely. Patient reassessed, reports rash has resolved, itchiness has resolved. Patient continues to deny any swelling of lips tongue or throat, no difficulty breathing, no nausea or vomiting. Discussed at length with the patient that Nurse do not advise her to get the second dose of the vaccination as it can cause repeat allergic reaction, possibly worse allergic reaction. Discussed possibility of obtaining the mother no vaccine once it becomes available. Patient understands. Discussed need for close follow- up with primary care physician, Extensive discussion return precautions. Discharging. The patient was reexamined. They have had symptomatic improvement during their ED stay. nurse discussed today's findings with the patient, explaining the pertinent positives and negatives from today's visit, and the plan of used plan for discharge as there is care. No emergent indication for admission. Discussed limitation of the ED work-up and that this is to rule out life-threatening emergencies but that they could require further testing as determined by their primary care and or any referred specialist patient is agreeable and understands need for follow-up and repeat exam/testing. Patient is aware that discharge does not mean there is nothing wrong. Indicates no emergency is present, and that they must continue their care with their primary care physician and/or any referred specialist. They were given appropriate follow-up with their primary care physician and/or specialist. nurse had an extensive discussion on the expected clinical course and return precautions. Patient understands to return to the emergency department for continuation, worsening, or new symptoms. Nurse answered any of the patient's questions. Patient was discharged home in a stable condition. As of 14:11 EST Vitals: BP - 144/86, HR -79, Temp - 97.6 OF (36.4 (Tympanic) 02 SATS - 96%. DISPOSITION: DISCHARGE: Patient discharged in stable condition. Reviewed implications of results, diagnosis, meds, responsibility to follow up, warning signs and symptoms of possible worsening, potential complications and reasons to return to ER. Patient/Family voiced understanding of above instructions. Discussed plan for discharge, as there is no emergent indication for admission. Patient referred to primary care provider for BP management due to today' BP. Pt/family is agreeable and understands need for follow up and repeat testing. Pt is aware that discharge does not mean that nothing is wrong but it indicates no emergency is present that requires admission and they must continue care with follow-up as given below or physician of their choice. Schedule an appointment as soon as possible for a visit in 2 days. Medication List NO changes were made to your prescriptions during this visit. ED Treatment Team. Previous ED Visit: None. ED Arrival Information: Arrival: 08Jan2021 12:27 PM. Means of Arrival: Car. Escorted By: Self. Service: Emergency Medicine Acuity: Emergent. Admission Type: Emergency. ED deposition: Discharged: condition stable. Triage sepsis screen: Row name: Sepsis screen. Documented or Suspected Infection: 0. Documented or Suspected Infection. Indications: None. Acutely Altered Mental Status:0. Temp <96.8 OR > 100.9: 0. Heart Rate >90): 0. Respiratory Rate > 20: SBP < 90:0 MAP < 65:0 Blood Glucose >140(mg/dL)- Not diabetic: WBC <4 or>12 (10*3/mmm3: Unknown Bands >10%. Result of current screen is: Negative. Medication administration from 08Jan2021 12:27 to 09Jan2021 02:02: None. ED Prescription: None. Discharge Orders (From admission, onward): None. Allergies (Reviewed on: 08Jan2021) Agent Bee Venom Severity: High, Shellfish-derived Products, Severity: High Comments: Anaphylaxis. Coconut Comments: Facial swelling. Codeine Comments: Vomiting. Other Severity: Phenofibrates cause Skin hives. Immunizations Administered Name: COVID-19 (PFIZER) Tetanus Up TO Date: None. ED LDA Documentation (to) Patient Lines/Drains/Airways Status Active Airway / Central Venous Catheter Line / Drain / Epidural Line / Intraosseous Line / Peripherally Inserted Central Catheter Line / Peripheral Intravenous Line / Arterial Line: None. Weight: 72.6 kg (160 1b). Height: 157.5 cm (62""). Oxygen Therapy from 07Jan2021 14:02 to 08Jan2021 14:02. Oxygen Therapy from 07Jan2021 14:02 to 08Jan2021 14:02 (continued) Date and Time 08Jan2021 14:00 (also reported 14: 11) sp02: 96 %. Date and Time 08Jan2021 12:58 Device (Oxygen Therapy: Room air. Date and Time: 08Jan2021 12:54 sp02: 96 % Device (Oxygen Therapy: Room air. Date and Time 08Jan2021 12:29 sp02: 97%. Breathing Date and Time: 08Jan2021 14:00, Date and Time: 08Jan2021, 12:54 Date and Time: 08Jan2021 12:29 were sp02:96 %, sp02:96 % and sp02:99 %. 08Jan2021 14:00 Departure Condition: Stable, Mobility at Departure: Ambulatory Patient Teaching Discharge instructions reviewed; Follow-up care reviewed; Medications discussed; Patient verbalized understanding. ED Events: Date/Time 08Jan2021 12:27 Patient arrival, Arrival info file, 08Jan2021 12:29 Triage Started, Patient roomed in ED, 08Jan2021 12:32 Assign Attending, Assign Provider, First Provider, Evaluation of Patient, 08Jan2021 12:52 Registration Completed 08Jan2021 12:56 Triage Completed, 08Jan2021 14:02 Patient discharged, ED Tracking End. Follow-up Information: Details Schedule an appointrnent as soon as possible for a visit in 2 days. Specialty: Family medicine Discharge Instructions: You have been given emergency department evaluation. This evaluation is intended to rule out life-threatening conditions. Is not a complete evaluation. You could require further testing as determined by your primary care physician or any referred specialist. Please follow-up with all doctors that you are referred to. Please be sure to take your prescribed medications and follow any specific instructions in the discharge instructions. Please follow-up with your primary care physician within 48 hours. Please have your primary care provider recheck your blood pressure. Please return to the emergency department if you experience chest pain, shortness of breath. abdominal pain, fever greater than 102, intractable vomiting. Please return to the emergency department if your symptoms continue or worsen, or if you begin to experience any other concerning symptom.Discharge References/Attachments: Hives Easy-to-Read AVS Reports: Date/Time: 08Jan2021: Report: COVID-19: Overview & Impact. Date/Time: 08Jan2021 Report: ED after Visit Summary. Chart Review Routing History No routing history on file. Case Management registry, Status: Active, First included on: 08Jan2021 2:20 PM, Emergency Encounter Documentation Registry, Status: Active, First included on: 09Jan2021 12:06 AM, Emergency Encounters Registry Status: Active, First included on: 08Jan2021 12:36 PM. Patient was recovering from the events. Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of Anaphylactic reaction, hives, itching and Eye swelling cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]; EPIPEN; PRINIVIL; ZESTRIL; TOPROL XL; VALTREX; AMBIEN; PHENERGAN [PROMETHAZINE],,"Medical History/Concurrent Conditions: Alcoholic (comment: socially rare, Drug use: Never); Anaphylaxis (Patient does have a history of anaphylaxis to bee stings); Breast cancer; Food allergy; Gallbladder operation; Hot flashes; Hysterectomy; Lumpectomy; Lymphadenectomy; Mastectomy; Seasonal allergy; Shellfish allergy (Shellfish-derived products); Smoker (Former Smoker, Years since quitting: 21, Smokeless tobacco: Never Used)",,,"['Anaphylactic reaction', 'Blood pressure measurement', 'Body height', 'Body temperature', 'Electrocardiogram', 'Eye swelling', 'Heart rate', 'Investigation', 'Laboratory test', 'Oxygen saturation', 'Pruritus', 'Respiratory rate', 'Scan', 'Urticaria', 'Weight']",1,PFIZER\BIONTECH, 1035537,,,F,"developed paralysis in the opposite part of the body; Her hand, fingers and knee all became swollen; Her hand, fingers and knee all became swollen; This is a spontaneous report from a contactable consumer via Pfizer Sponsored program Pfizer First Connect. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient took the first dose of the vaccine on an unknown date for COVID-19 immunization. In Feb2021, about 12 hours after getting the vaccine, the patient developed paralysis in the opposite part of the body where she didn't get the vaccine. Her hand, fingers and knee all became swollen. She had the symptoms on her right and was given the vaccine in her left. The final outcome of the events was unknown.Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/01/2021,,UNK,,,,,,"['Joint swelling', 'Paralysis', 'Peripheral swelling']",2,PFIZER\BIONTECH, 1035538,GA,64.0,F,"the reaction is inflammation to her retina; dose given 11Jan2021, and second dose LOT: EK9231 for dose given on 28Jan; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via an unspecified route of administration on 28Jan2021 at sngle dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot: EH9899) received on 11Jan2021 for COVID-19 immunisation. Patient went to her ophthalmologist and they examined her eye. The ophthalmologist said that the reaction was inflammation to her retina. Outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,,,UNK,,,,,,"['Inappropriate schedule of product administration', 'Ophthalmological examination', 'Retinitis']",2,PFIZER\BIONTECH, 1035539,OH,88.0,F,"Fall; fatigued; arm pain; AML; Sepsis secondary to AML; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), via an unspecified route of administration on 19Jan2021 17:30 in right arm at single dose for covid-19 immunization. Medical history included hypertension, hyperlipidemia, OA (osteoarthritis), cognitive impairment. No other vaccine in four weeks was administrated. Concomitant medication in two weeks included atorvastatin, aspirin, calcium, gabapentin, losartan and memantine hydrochloride (NAMENDA). The patient previously took lisinopril and tetracycline and both experienced allergies. The patient had no covid prior vaccination. The patient initially had no symptoms but arm pain in Jan2021, no bleeding or bruising from injection. On 31Jan2021 19:00, patient felt fatigued. Patient suffered fall on 01Feb2021. She was admitted to hospital. All cell lines were down in Feb2021. She was diagnosed with AML (acute myeloid leukemia) in 2021. She expired 07Feb2021. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event) and patient died. The patient received the treatment of blood and platelet transfusions, bone marrow biopsy, cytogenetic testing, antibiotics, intubation for events. The patient died on 07Feb2021 due to sepsis secondary to AML. An autopsy was not performed. Outcome of events were fatal.; Reported Cause(s) of Death: arm pain; fatigued; fall; Sepsis secondary to AML; Sepsis secondary to AML",Yes,02/07/2021,Yes,Yes,6.0,Not Reported,N,01/19/2021,01/01/2021,,PVT,ATORVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]; CALCIUM; GABAPENTIN; LOSARTAN; NAMENDA,,Medical History/Concurrent Conditions: Cognitive impairment; Hyperlipidemia; Hypertension; Osteoarthritis,,,"['Acute myeloid leukaemia', 'Fall', 'Fatigue', 'Full blood count', 'Pain in extremity', 'Sepsis']",1,PFIZER\BIONTECH, 1035540,NY,44.0,M,"loss of feeling in legs as well as incoherent behavior; loss of feeling in legs as well as incoherent behavior; Upon a CT scan an aneurysm was discovered that was actively bleedings.; extreme headache/severe headaches; went to ER via ambulance in 31Jan2021 for extreme headache and body lameness; This is a spontaneous report from a contactable Consumer. A 44-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medication included allergy pills. Patient went to emergency room (ER) via ambulance on 31Jan2021 for extreme headache and body lameness, which started on 31Jan2021 22:00. Patient was discharged from ER on 01Feb2021. Patient returned to ER via ambulance on 09Feb2021 due to severe headaches and loss of feeling in legs as well as incoherent behavior. Upon a Computerised tomogram (CT) scan an aneurysm was discovered that was actively bleedings. Patient was transferred to medical center and is currently waiting surgical procedure. Adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Yes,Yes,,Not Reported,U,01/28/2021,01/31/2021,3.0,UNK,,,,,,"['Aneurysm ruptured', 'Behaviour disorder', 'Computerised tomogram', 'Headache', 'Sensory loss', 'Walking disability']",2,PFIZER\BIONTECH, 1035541,MO,67.0,F,"syncope within 10 min. of injection, episode; BP 70/40 P 40-30 admitted to ICU; BP 70/40 P 40-30 admitted to ICU; Adrenal Crisis; patient with a medical history CVID (Immunodeficiency common variable) received bnt162b2; patient with a medical history CVID (Immunodeficiency common variable) received bnt162b2; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date unknown), via an unspecified route of administration in Left arm on 19Jan2021 at single dose for COVID-19 immunization in hospital; antilymphocyte immunoglobulins (reported as immunoglobulin infusion, concentrate for solution for infusion, lot/batch number and expiration date not provided) via an unspecified route of administration from an unspecified date at unknown dosage for an unspecified indication. Medical history included CVID (Immunodeficiency common variable), Addison Dx (diagnosis) and Pituitary Tumor. Prior to vaccination, patient was not diagnosed with COVID-19. No known allergies. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had syncope within 10 minutes of injection on 19Jan2021, episode, BP (blood pressure) 70/40, P (pulse) 40-30, admitted to ICU in Jan2021, determined adverse event maybe 2nd to immunoglobulin infusion received previous day leading to Adrenal Crisis, 2nd to Addison dx / Pituitary tumor which was unknown at time of vaccination. Events were resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Patient had been hospitalized for 6 days in Jan2021. Since the vaccination, patient had not been tested for COVID-19. The action taken in response to the events for antilymphocyte immunoglobulins was unknown. Therapeutic measures were taken as result of the events syncope, BP 70/40, P 40-30 and Adrenal Crisis. The outcome of the events ""syncope, BP 70/40, P 40-30, Adrenal Crisis"" was recovered in 2021. Patient then received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Feb2021. Pfizer is a marketing authorization holder of antilymphocyte immunoglobulins in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of antilymphocyte immunoglobulins has submitted the same report to the regulatory authorities. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT152B2 and antilymphocyte immunoglobulins to the events syncope, low BP and heart rate, adrenal crisis, cannot be excluded. The underlying Addison disease and Pituitary Tumor are major cofounders for the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,6.0,Not Reported,Y,01/19/2021,01/19/2021,0.0,PVT,antilymphocyte immunoglobulins,,Medical History/Concurrent Conditions: Addison's disease; Immunodeficiency common variable; Pituitary tumor NOS,,,"['Adrenocortical insufficiency acute', 'Blood pressure decreased', 'Blood pressure measurement', 'Heart rate', 'Heart rate decreased', 'Off label use', 'Product use issue', 'Syncope']",UNK,UNKNOWN MANUFACTURER, 1035542,UT,82.0,M,"passed away; This is a spontaneous report from a contactable consumer (patient's granddaughter). An 82-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN9581), via an unspecified route of administration on 08Feb2021 at 14:30 into right arm at single dose for COVID Prevention. Medical history included Heart valve replacement from 5 years before 09Feb2021 (2016), on Oxygen at night (reporter did not know the liter amount that the patient used at night). The patient's concomitant medications were not reported. Patient had no other vaccines on the same day as the COVID vaccine. It was reported that patient received his first dose of the Pfizer vaccine around 14:30 on 08Feb2021 and he was fine before that, and by 16:30, he had passed away on 08Feb2021. Reporter reported that the cause of death was unknown at this time and that the family would be having an autopsy performed but that it had not yet been performed. No investigation assessment could provide. The patient died on 08Feb2021 at 16:30. An autopsy was not performed.; Reported Cause(s) of Death: passed away",Yes,02/08/2021,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/08/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Heart valve replacement; Oxygen supplementation (On Oxygen at night),,,['Death'],1,PFIZER\BIONTECH, 1035543,FL,68.0,F,"out like a 'light' and this stuff knock her out; whole entire face her head, down her back her neck was numb/Numbness in leg/jaws are numb; I'm feeling my teeth are still and my jaws are numb; felt very odd sensation as she was swallowing; was closing up but much wasn't closing up/it was not full open; swelling on her throat; Muscle pain in my left arm where they gave me injection and it hurts my neck area across my back down my arms specially my left side; it hurts my neck area across my back; it hurts my neck area across my back; Stumbling; face was swollen; eyes looks like little switch; thirsty; felt very sluggish; nose started to running; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first single dose BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (anatomical location: arm left) on 29Jan2021 15:00 for COVID-19 immunization. Medical history included insomnia and asthma. The patient's concomitant medications were not reported. Patient stated, ""I got the vaccine yesterday about 3 pm and I came home and I had dinner and sat down to watch TV at 9 O' clock, I turn the program on and I was out like a 'light' and this stuff knock me out (onset date: 29Jan2021). My dog has to wake me up licking my face at 3:15 this morning. I normally don't sleep long 4 hours and that's it. I'm 68 years old and I have insomnia (History) but when I woke up I was stumbling around, still have to sleep (onset date Jan2021), I took the dog out to walk and came back and saw myself in mirror, my face was swollen and my eyes looks like little switch. I noticed, I was thirsty and I went to get and drank, some coke because I felt very sluggish and I drank some coke and when I was swallowing the coke I felt very odd sensation as I was swallowing, I noticed that after swallowing. I have asthma (History) to begin with so I'm anticipated on having some of the symptoms it start showing up a bit, my nose started to running and I noticed that my whole entire face my head, down my back my neck was numb along with swelling on my throat, I felt okay but I felt it wasn't being, it was closing up but much wasn't closing up you know what I mean it was not full open. I also had muscle pain in my left arm where they gave me injection and it hurts my neck area across my back down my arms specially my left side. I also noticed I went to a lovely person and when I went to bathroom I pull my pants down I felt numbness on my legs. So, my whole body was kind of having that not tingling sensation but numb and when I ran my fingers across my leg you know how you feel numbness when you run your fingers across a part of your body when it's numb that's exactly how I felt and that was about 3:30 this morning that happened I woke up by but I also want to ask question because I got to go back to my second shot. I'm wondering if I go back to my second dose am I going to have even more intense reaction to the stuff that I get this time."" Patient further added ""I was still trying to eat something but I'm feeling my teeth are still and my jaws are numb and this I got since yesterday (29Jan2021)."" The outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Asthma; Insomnia,,,"['Back pain', 'Dysphagia', 'Eye disorder', 'Gait disturbance', 'Hypoaesthesia', 'Hypoaesthesia teeth', 'Neck pain', 'Pharyngeal swelling', 'Rhinorrhoea', 'Sluggishness', 'Somnolence', 'Swelling face', 'Thirst', 'Throat tightness', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1035544,IL,28.0,F,"stroke; a thunder clap headache; limbs stiffened up; eyes crossed; lost speech; She is now on day three of a coma on life support from a brain aneurysm; Mood swings; irate; Body aches; This is a spontaneous report from a Contactable Consumer, the patient. This 28-year-old non-pregnant female consumer (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the left arm on 01Feb2021 as a single dose, for COVID-19 vaccination. Historical vaccination includes BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 1. The facility in which the second vaccine was administered was a hospital. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. No Medical history reported ('No health issues, At all'). The patient has no known allergies. There were no concomitant medications. On an unspecified The Patient Experienced became irate. Mood swings. Body aches for couple days; On 07Feb2021 at 13:45, The patient experienced Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm (hospitalization, disability, life threatening), Treatment was given for the events of stroke, a thunder clap headache, limbs stiffened up, eyes crossed, lost speech, and brain aneurysm. The Adverse Event resulted in an Emergency Room Visit. Treatment was given for the events. 'Patient on Life support still'. The Clinical Outcome of the events Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm not recovered, while Mood Swings, Anger and Pain was unknown. Information on Lot has been requested.",Not Reported,,Yes,Yes,,Yes,N,02/01/2021,02/07/2021,6.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Anger', 'Aphasia', 'Cerebrovascular accident', 'Headache', 'Intracranial aneurysm', 'Mood swings', 'Musculoskeletal stiffness', 'Pain', 'Strabismus']",2,PFIZER\BIONTECH, 1035545,NY,,M,"Death; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received Covid 19 Vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for covid-19 immunization.The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter was calling about the Covid 19 Vaccine. Reporter stated that she gets information every day from the nursing home. Reporter stated that she will provide the name of the Nursing home, she just forgot to put it down. The patient, within 2 days dead from it, he was perfectly healthy. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on Lot/batch number has been requested.; Reported Cause(s) of Death: Death",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],UNK,PFIZER\BIONTECH, 1035546,FL,94.0,F,"Stroke; This is a spontaneous report from a contactable consumer. A 94-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 16Jan2021, at single dose, for COVID-19 immunisation. Medical history included ongoing hypertension (took medication). Patient did not have COVID-19 prior to vaccination. Concomitant included unspecified medication for hypertension. The patient experienced stroke on 31Jan2021. The patient was brought to the emergency room and hospitalized due to the event on 31Jan2021. No therapeutic measures were taken as a result of the event. The patient underwent lab tests and procedures which included COVID-19 virus test: negative in Feb2021 (a week before report); investigation: brain bleed and discovered she had a stroke (on unknown date in 2021). The patient died on 03Feb2021 due to stroke and old age. An autopsy was not performed. Patient's family did not attribute her death to the vaccine at all. The information on the Lot/Batch number has been requested.; Reported Cause(s) of Death: stroke; Old age",Yes,02/03/2021,Not Reported,Yes,,Not Reported,N,01/16/2021,01/31/2021,15.0,UNK,,Hypertension (Took medication),,,,"['Cerebrovascular accident', 'Investigation', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1035547,FL,71.0,M,"left parietal CVA; left popliteal DVT; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= el 1284), via an unspecified route of administration on 22Jan2021 17:00 at single dose at left arm for covid-19 immunization. Medical history included cholesterol. Concomitant medications in two weeks included atorvastatin (LIPITOR), esomeprazole sodium (NEXIUM), triazolam and OTC vitamin. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 05:30 AM, the patient experienced left parietal CVA and left popliteal DVT (hospitalization, life threatening) with outcome of recovering. The patient was hospitalized for both events for 5 days. The patient underwent lab tests and procedures post vaccination which included nasal swab: unknown results. Patient received TPA (Tissue plasminogen activator), blood thinners as treatment. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event).",Not Reported,,Yes,Yes,5.0,Not Reported,N,01/22/2021,01/26/2021,4.0,PVT,LIPITOR [ATORVASTATIN]; NEXIUM [ESOMEPRAZOLE SODIUM]; TRIAZOLAM,,Medical History/Concurrent Conditions: Blood cholesterol abnormal,,,"['Cerebrovascular accident', 'Deep vein thrombosis', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1035548,FL,73.0,M,"Repetitive episodes of tingling; numbness occurring in left side of body including side of face; Possible TIA; This is a spontaneous report from a contactable consumer reporting for himself. A 73-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9262), via an unspecified route of administration in the left arm on 02Feb2021 16:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included amlodipine (unknown manufacturer). On 02Feb2021 16:00 the patient experienced repetitive episodes of tingling and numbness occurring in left side of body including side of face; possible TIA with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient was hospitalized for 3 days due to the events. The events were serious as life-threatening and due to hospitalization. It was unknown if the patient received treatments for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.",Not Reported,,Yes,Yes,3.0,Not Reported,N,02/02/2021,02/02/2021,0.0,UNK,AMLODIPINE,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Hypoaesthesia', 'Paraesthesia', 'Transient ischaemic attack']",1,PFIZER\BIONTECH, 1035549,,,M,"Thrombocytopenia; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced thrombocytopenia on an unspecified date, the seriousness of the event reported as death. The patient died two weeks after receiving a COVID-19 vaccine. Patient's wife said that he died from a condition known as thrombocytopenia, marked by a shortage of the blood platelets that help stop bleeding, after he received BNT162B2. The patient underwent lab tests and procedures which included blood bilirubin: 1.50, blood osmolarity: 297, blood pressure measurement: 159/106, blood urea: 22.3, monocyte count: 12.1 %, platelet count: thrombocytopenia, platelet count: platelet count decreased again to 0 on 21Dec2020. The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Thrombocytopenia",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Blood bilirubin', 'Blood osmolarity', 'Blood pressure measurement', 'Blood urea', 'Monocyte count', 'Platelet count', 'Thrombocytopenia']",UNK,PFIZER\BIONTECH, 1035550,OH,86.0,F,"Blood blister; hands, feet, torso are covered and painful/soreness and tenderness of palms; has trouble with ambulation; torso are covered and painful; This is a spontaneous report from a contactable nurse (patient's daughter). An 86-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry: Mar2021), intramuscular in the left upper arm on 25Jan2021 13:30 at a single dose for protection against virus. Medical history included COVID from 18Nov2020 and ongoing (recovering/resolving). The patient's concomitant medications were not reported. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry: Mar2021) intramuscular in the left arm on 04Jan2021 for protection against virus with no problem. On 26Jan2021, patient had one tiny blood blister but now was covered in them. Her hands, feet, and torso are covered and are painful. The patient has trouble with ambulation and using her walker since. The palms of her hands are covered front and back too. The patient was also covered on her toes and areas of the abdomen around the umbilicus area. Had the first dose on 04Jan2021 and the second on 25Jan2021. Her mother has an appointment on 03Feb2021, and caller wanted to know if this is uncommon or a rare side effect. The reporter has found a couple of articles, but most of them refer to pediatrics and rashes and she didn't see any side effects about blood blisters for her mother's age group. Further stated that areas covered are progressively worse and disabling since her mother was using a walker to ambulate. Has not been able to really use the walker due to the soreness and tenderness of palms. Her mother had the disease (COVID) back on 18Nov2020 and was symptomatic and was mild. No other vaccines received the same time. No history of problems with vaccines in past. They can't think of nothing that was new, no new medications, lotions, creams, or detergents, nothing new. The events did not require a visit to emergency room nor a physician office. Onset date of events reported was on 26Jan2021 with outcome of not recovered. The reporter assessed the seriousness of events as disability. The events were assessed as related to vaccines.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/25/2021,01/26/2021,1.0,UNK,,COVID-19 (Recovering/Resolving),,,,"['Blood blister', 'Gait disturbance', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,OT 1035551,OR,33.0,F,"vaccine is really taking a big toll on her brain function; feels just weird, like everything is in slow motion/feeling really weird; dizzy/lightheaded; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left deltoid on 02Feb2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient got the COVID vaccine a couple hours ago on 02Feb202 and was very lightheaded. When the patient was asked to provide her mailing address, she stated she was feeling really weird, the vaccine was really taking a big toll on her brain function, she was super dizzy and feels just weird, like everything is in slow motion. Lightheadedness started probably about 20 minutes after she had the shot, they made her wait for 15 minutes, now she just feels really weird. The patient was healthy, she just got blood tests back and everything said she is healthy. She thought they said to call if she was having a side effect of dizziness or weakness, as they are more serious, but she called her doctor and they said to call Pfizer. The outcome of the events was unknown. The patient underwent lab tests and procedures which included blood test: unknown results on unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,,,UNK,,,,,,"['Blood test', 'Dizziness', 'Feeling abnormal', 'Mental impairment']",1,PFIZER\BIONTECH, 1035552,,,F,"approxmately 1:30 Pm the resident passed away; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported that a female patient of an unspecified age (reported as 85 without unit) received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscular at left arm on 29Dec2020 11:29 at single dose for COVID-19 immunization. Medical history included dementia, aphasia, type 2 diabetes mellitus (DM), iron deficiency, asthenia, osteoporosis, polyneuropathy, anxiety, Major depressive disorder (MDD). Concomitant medication included gabapentin, memantine. The patient had allergies to codiene, phenobarbital, penicillin. The vaccine was administrated with no immediate adverse reaction at 11:29. Vaccine screening questions were completed and resident was not feeling sick and temperature was 98F. At approximately 13:30 on 29Dec2020, the resident passed away. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: approxmately 1:30 Pm the resident passed away",Yes,12/29/2020,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,UNK,GABAPENTIN; MEMANTINE,,Medical History/Concurrent Conditions: Anxiety; Aphasia; Asthenia; Dementia; Iron deficiency; Major depressive disorder; Osteoporosis; Penicillin allergy; Polyneuropathy; Type II diabetes mellitus,,,"['Body temperature', 'Death']",1,PFIZER\BIONTECH,OT 1035553,,76.0,F,"Pt passed soon after; shortly after progressed with other covid symptoms and was admitted / acute resp failure, COVID pneumonia; acute resp failure, COVID pneumonia; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; This is a spontaneous report from a non-contactable Pharmacist. A 76-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number EL3247), intramuscular on 19Jan2021 at single dose for COVID-19 immunisation. The patient medical history included COVID symptoms from 16Jan2021 and ongoing. Concomitant medications were not reported. The patient with acute resp failure, COVID pneumonia, that developed symptoms 9 days prior to admit and ultimately received first vaccine 6 days prior to a admit, then shortly after progressed with other covid symptoms and was admitted on 25Jan2021. She decompensated while intp and was transferred to ICU for rising O2 needs, ultimately had to be intubated. Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle. Sx and IR consulted and did beside exploration of hematoma. Initially blood pressure responded but overnight continued with refractory hypotension. Maxed out vasopressin and levophed, hemodynamics deteriorated. The patient died on 02Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events death, COVID-19 pneumonia, acute respiratory failure, hypotension, abdominal wall haematoma and abdominal wall haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Pt passed soon after",Yes,02/02/2021,Not Reported,Yes,9.0,Not Reported,N,01/19/2021,01/25/2021,6.0,PVT,,Suspected COVID-19,,,,"['Abdominal wall haematoma', 'Abdominal wall haemorrhage', 'Acute respiratory failure', 'COVID-19 pneumonia', 'Death', 'Hypotension']",1,PFIZER\BIONTECH,OT 1035555,CA,68.0,M,"When he went to the bathroom it was like diarrhea, watery, and had blood; He also had pains in his stomach; he could hardly move; Last night he sweated, the sheets were all wet; Pain on the right side of his back/ night before he had it on his left side/ he moved it hurt so bad; He only slept for 4 hours; Fever and chills; Fever, temperature was only 100; his blood pressure went up; Stomach problems; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL9265), via an unspecified route of administration at the left arm on 27Jan2021 at a single dose for covid-19 immunization. The vaccine was administered in a hospital. Medical history included ongoing high blood pressure and ongoing cholesterol. Ongoing concomitant medications included lisinopril for high blood pressure, amlodipine for high blood pressure and atorvastatin for cholesterol. The patient previously took montelukast and dries up his sinuses. On 27Jan2021 he received the first dose in the afternoon about 5 o'clock or a little after. It started with stomach problems on 27Jan2021. He kept feeling like he had to go to the bathroom all throughout the night on 27Jan2021. He slept through the night and was okay. He had a little something going on in his stomach. The next day (28Jan2021), that evening, around 7pm he had fever and chills and his blood pressure went up. His temperature was only 100. It never went over that. And he was having to go to the bathroom. In the morning, it was fine but at night he was having to go. Normally he has a bowel movement in the morning. When he went to the bathroom it was like diarrhea, watery, and had blood. It was not dried blood, but blood. It happened twice. He then had to go again. The same thing happened again and then it stopped. He also had pains in his stomach. He went to sleep and the next day he went to the bathroom the first thing in the morning and it was normal. The reported also mention that stomach problems were worse on 28Jan2021. He only slept for 4 hours on 28Jan2021. The next day, 29Jan2021 he was fine. He only had a little bit of a fever and a little bit of chills. Then the chills and fever went away that day. He did not feel ill or weak at all when this was happened which is why he did not go to the doctor. He did not feel that the symptoms were bad enough. He felt okay once they were over. He had to get it out. On 31Jan2021, he also had fever and pain on the right side of his back. It was a really sharp pain and he could hardly move. The night before he had it on his left side. He made himself get out of bed. When he moved it hurt so bad. On 31Jan2021, he sweated, the sheets were all wet. He slept 4 hours. He has been using ice packs and icing it down. The pain on the right side has gone away but the pain on the left side is still there. It has improved and there is only a little pain. He iced it down first thing this morning. He walks everyday. The outcome of the event diarrhea bloody was recovered on an unspecified date, stomach problems and his blood pressure went up recovered on 28Jan2021; pain back was recovering; outcome for all other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,PVT,LISINOPRIL; AMLODIPINE; ATORVASTATIN,Blood cholesterol abnormal; Blood pressure high,,,,"['Abdominal pain upper', 'Back pain', 'Blood pressure increased', 'Blood pressure measurement', 'Body temperature', 'Chills', 'Diarrhoea haemorrhagic', 'Gastric disorder', 'Insomnia', 'Mobility decreased', 'Night sweats', 'Pyrexia']",1,PFIZER\BIONTECH, 1035556,TX,87.0,F,"stayed up all night, slept all day; Hallucinations/ just saw people but never heard voices; stayed up all night, slept all day; This is a spontaneous report from a contactable consumer (patient's daughter). An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EN5318, expiration date unknown) via an unspecified route of administration on the right arm on 01Feb2021 at a single dose as vaccine for COVID-19. The patient had no medical history and no concomitant medications. On 01Feb2021 23:00, the patient experienced hallucinations. It was reported that patient started hallucinating on 01Feb2021 23:00 and just saw people but never heard voices. The reporter stated that her mom never had hallucinations ever. The patient feared people were in the house and stayed up all night (from 01Feb2021 23:00), slept all day (on 02Feb2021). The reporter wanted to know if they have ever heard of this happening. She has made an appointment with the patient's doctor. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Fatigue', 'Hallucination, visual', 'Poor quality sleep']",1,PFIZER\BIONTECH, 1035557,NY,32.0,M,"Swollen lymph nodes; Developed Shingles on his face; This is a spontaneous report from a contactable other healthcare professional. This other healthcare professional reported for a 32-year-old male patient (her fiance). A 32-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration at the right arm on 29Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of bnt162b2 on 08Jan2021 for COVID-19 immunization. The patient developed shingles on his face on 31Jan2021 and swollen lymph nodes on 01Feb2021. The events were reported as serious (medically significant) and worsened. There were no investigation assessment. The patient had not recovered from the events at the time of the report. Information on the batch number has been requested.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the Company considers the event swollen lymph nodes is possibly related to suspect vaccine BNT162B2. Other than a temporal association, there is no evidence or argument to suggest a causal relationship between BNT162B2 and the event shingles, which is likely an intercurrent condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/31/2021,2.0,UNK,,,,,,"['Herpes zoster', 'Lymphadenopathy']",2,PFIZER\BIONTECH, 1035558,MI,70.0,F,"Low platelets; Rash on her body; Bruising; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3249), via an unspecified route of administration in the right arm on 19Jan2021 at a single dose for covid-19 immunization. Medical history included ongoing diabetes mellitus since 2011 (reported diagnosed 10 years from this report, ongoing congenital heart defect which patient was born with but did not find out until she was in her 50s; does not bother her too much; one of the major arteries has a 90 degree angle vs. an S curve, mild multiple sclerosis; no longer has this as she has not had another relapse; she was diagnosed almost 30 years ago; she has never had another attack since she had 2 of them and was on medication that did damage to her liver, breast cancer; patient is a breast cancer survivor and issues with magnesium levels. There were no concomitant medications. On 28Jan2021 the patient had blood work done for her kidney doctor. They withdrew blood from her arm. They had a hard time stopping the bleeding afterwards. They finally got it to stop and put regular cotton balls and a band aid on it. By the time she was walking out she was bleeding out of her arm she felt in her coat. They were able to stop the bleeding again. This was at about 10 AM. Patient went home and afterwards was called back and instructed to go to the ER for critical care. Her platelets were low at 10,000 at that time. They got to the ER and they checked her platelets and they were down to 8,000. They administered some steroids; Prednisone. They decided to admit her after giving the treatment in the ER. After that her platelets came back to 11,000. The next morning on 29Jan2021 her platelet count was 7,000. They started administering the same drug through an IV. He thinks it was still a steroid. They did it in smaller amounts and overnight the next day her platelets were up to 26,000 on 30Jan2021. They continued the treatment during the night again and on Sunday they were 36,000 and they released her that day late on Sunday. They went back and did blood work yesterday on 01Feb2021. The local doctor said her platelets are up to 61,000. The patient was getting blood work every Monday and Thursday for 3 weeks. Th patient had blood work and platelets checked before the vaccine and they were normal. The patient was hospitalized from 28Jan2021 to 31Jan2021 due to the event. The patient also noticed rash on her body and bruising maybe on 21Jan2021 or 22Jan2021. The bruising was really bad on her left hand by her wrist. It was really dark. She was also bruised everywhere they poked her with an IV and bruises where they put the heart monitor on her and pressed down to stick it to her. The bruising is still all over her body. It has stayed about the same. The one on her hand is still severe. The other from where she has been poked are starting to clear up. Overall it was about the same. The outcome of event bruising was not recovered, low platelets was unknown while rash on her body recovered on unspecified date.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/19/2021,01/01/2021,,UNK,,Congenital heart valve disorder; Diabetic,Medical History/Concurrent Conditions: Breast cancer; Magnesium metabolism disorder; Multiple sclerosis,,,"['Contusion', 'Platelet count', 'Platelet count decreased', 'Rash']",UNK,PFIZER\BIONTECH, 1035559,NC,81.0,M,"Stroke; like he had a film over his eye, it was cloudy, like a cloudy day; This is a spontaneous report from a contactable consumer (patient). A 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL1283 and expiry date: 30Apr2021) solution for injection, intramuscular in left arm on 18Jan2021 13:10 at a single dose for Covid-19 immunization. Medical history included chicken pox, measles, and mumps (had chicken pox vaccine, measles, and mumps when he was younger, and he got the flu shot for flu). The patient's concomitant medications were not reported. The next day (19Jan2021) after receiving the injection, patient reported it was like he had a film over his eye, it was cloudy, like a cloudy day. This went on for a couple of days before it improved. There was still a little bit in his left eye, but he can read and it has improved. He can see now and his eyes were improving. He found out that he had a stroke on 28Jan2021. He did not go to the hospital. He does not think the stroke affected anything else. He was supposed to have an MRI sometime this week. He went to the eye doctor and the eye doctor was the one that discovered the stroke and his eye doctor sent the report over to his primary office. He had a vision field test which was how the stroke was diagnosed. He was taking a baby aspirin and he will be put on a blood thinner called Plavix. He has not started Plavix yet, he has to go pick it up. Outcome of the event stroke was unknown while the other events was recovering. No follow-up activities are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/19/2021,1.0,PVT,,,"Medical History/Concurrent Conditions: Chickenpox (Chicken pox vaccine, measles, mumps when he was younger and he got the flu shot.); Measles (Chicken pox vaccine, measles, mumps when he was younger and he got the flu shot.); Mumps (Chicken pox vaccine, measles, mumps when he was younger and he got the flu shot.)",,,"['Cerebrovascular accident', 'Vision blurred', 'Visual field tests']",1,PFIZER\BIONTECH,OT 1035589,PA,85.0,F,"severe nausea, chills diarehha, throwing up",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/04/2021,02/05/2021,1.0,PVT,calcium,none,none,,none,"['Chills', 'Dehydration', 'Diarrhoea', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,SYR 1035597,GA,42.0,M,Death on 1/17/2021. Found at home deceased.,Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/17/2021,18.0,PVT,,unknown,"Unknown. Patient died on 01/17/2021. Related to vaccine? I do not know but am reporting because I sent an email to VAERS and never received an answer whether it should be reported or not. So, erring on the side of caution, I am reporting.",,NKA,['Death'],1,PFIZER\BIONTECH,IM 1035614,PA,66.0,M,Patient developed symptoms on 2/13/2021 with epistaxis. Then developed blood blisters in mouth and petechiae over lower extremities. Saw me on 2/16 and labs showed platelet count less than 3000.,Not Reported,,Yes,Yes,1.0,Not Reported,N,01/28/2021,02/04/2021,7.0,PVT,mvi aspirin 81 mg daily,none,Undifferentiated connective tissue disease Sjogren's syndrome,,none,"['Epistaxis', 'Oral blood blister', 'Petechiae', 'Platelet count decreased']",UNK,MODERNA,SC 1035624,AL,22.0,F,"Aggravated very quickly; Everything went blank; She can't talk and when she tries to talk she feels like she has the hiccups where she can barely get the words to talk; when she has a hiccup her whole chest hurts; Hiccup; Numbness; Her whole right side would jerk uncontrollably; Weak; fever; itching; sore arm / burning; chills; A spontaneous report (United States) was received from a consumer who was also a 22-year-old female patient, who received Moderna's COVID-19 vaccine who experienced sore arm/ burning (injection site pain), fever (pyrexia), chills, itching (injection site pruritus), numbness (injection site numbness), weak (asthenia), whole right side would jerk uncontrollably (myoclonus), everything went blank (loss of consciousness), couldn't talk and when she tried to talk she felt like she had the hiccups (aphasia), her whole chest hurt (chest discomfort), and quickly became aggravated (anger). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 06 Jan 2021, the patient received her first of two planned doses of mRNA-1273 intramuscularly in her right deltoid for prophylaxis of COVID-19 infection. On 06 Jan 2021, the patient experienced a sore arm, fever, chills, itching and burning. On 07 Jan 2021, on the site where the patient received the injection, she felt numbness and weak. Her whole right-side body would jerk uncontrollably. The patient went to two emergency rooms where they stated they did not know what was wrong and gave her a steroid injection that temporarily helped calm her down. On 08 Jan 2021, the patient stared at the door and everything went blank. She could not talk and when she tried to talk, she felt like she had the hiccups. She experienced her whole chest hurting when she had a hiccup. On 25 Jan 2021 and 26 Jan 2021, the patient saw two neurologists, who did testing. The patient's jerking was random, there were no triggers for it, and she did not know how to control or stop it. These adverse reactions made the patient become aggravated very quickly, which was not like her. On an unknown date, the patient stated it was the first day in the past month she had been able to talk all day. Treatment for the events included a steroid shot. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, sore arm/ burning, fever, chills, itching, numbness, weak, whole right side would jerk uncontrollably, everything went blank, couldn't talk and when she tried to talk she felt like she had the hiccups and her whole chest hurt, and quickly became aggravated, was not reported.; Reporter's Comments: Based on the current available information which indicates a strong temporal association between the use of the product and the onset of the reported events a causal relationship cannot be excluded. Chills, fever, injection site pruritus and injection site pain are consistent with the known safety profile of mRNA-1273.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Anger', 'Aphasia', 'Asthenia', 'Chest discomfort', 'Chills', 'Hiccups', 'Injection site hypoaesthesia', 'Injection site pain', 'Injection site pruritus', 'Loss of consciousness', 'Myoclonus', 'Pyrexia']",1,MODERNA,OT 1035625,NY,,F,"Fluid in the pericardium; Heart skips a beat; Out of breath; Heart pound when sedentary; A spontaneous report was received from a consumer who was also a 63-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fluid in the pericardium (pericardial efflusion), heart skips a beat (heart rate irregular) when out of breath (dyspnoea), and heart pounds when sedentary (palpitations). The patient's medical history included irregular heartbeat. Relevant concomitant medications taken within two weeks prior to the events were not provided. On 05 Jan 2021 at 12: 30 pm, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 02 Feb 2021, at 12:30 pm, the patient received their second of two planned doses of mRNA-1273 (Lot: 011J20A) intramuscularly for prophylaxis of COVID-19 infection. On an undisclosed date, the patient developed fluid in the pericardium, and her heart skipped a beat when out of breath. It would happen when she was sedentary, and her heart would pound when not walking. She had irregular heartbeat before and was prescribed a concomitant medicine which was a nasal steroid. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable. The outcome of the events, fluid in the pericardium, heart skips a beat when out of breath and heart pound when sedentary, were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time in this case of serious unlisted event of pericardial effusion and non-serious unlisted events of heart rate irregular, dyspnea, and palpitations. However, patient's medical history of irregular heartbeat is a confounding factor that may play a contributory role providing an alternative explanation. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,,,UNK,,,Medical History/Concurrent Conditions: Arrhythmia,,,"['Dyspnoea', 'Heart rate irregular', 'Palpitations', 'Pericardial effusion']",2,MODERNA,OT 1035641,KY,47.0,F,Healthcare was advised that this patient expired approximately two weeks after receiving her initial COVID vaccination,Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,01/24/2021,02/09/2021,16.0,PVT,Azathioprine 50mg po qd Bupropion XL 300mg po qam Furosemide 40mg po qd Nadolol 20mg po qd Omeprazole 20mg po qd Prednisone 20po qd Spironolactone 25mg po qd,"Tobacco Use - 0.5 pack per day cigarette use Autoimmune Hepatitis - flare in 2020, improved with increased immunosuppressants per GI note 12/15/20 Bilateral leg swelling 1/21/21 - Primary care office visit",Tobacco Use - 0.5 pack per day cigarette use Autoimmune hepatitis Essential Hypertension Migraine Mood disorder Allergic Rhinitis,,None,['Death'],1,PFIZER\BIONTECH,IM 1035659,GA,47.0,M,"TO ED ON 02/12 WITH KIDNEY STONE. ON LABWORK, PLATELETS NOTED TO BE LOW AT 85,000. I WAS NOTIFIED ON 02/16 BY THE UROLOGIST OF LOW PLATELETS WITH NO KNOWN CAUSE AND PATIENT/EMPLOYEE S/P COVID VACCINATION. ADMITTED TO HOSPITAL--DISCHARGED ON 02/14 AND PLATELETS 74,000 AT DISCHARGE. TO FOLLOW-UP OUTPT WITH PROVIDER TO RECHECK LABS.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/25/2021,02/12/2021,18.0,PVT,NONE,NONE,HISTORY OF KIDNEY STONES,,NONE,"['Condition aggravated', 'Full blood count', 'Nephrolithiasis', 'Platelet count decreased']",2,MODERNA,IM 1035674,FL,66.0,F,"Within 15-minutes, the patient reported a ""pulsating sharp pain"" behind their right eye. EMS evaluated the patient on-site and they were found to be hypertensive (173/88). The patient proceeded to a emergency department. In the ED, the patient remained hypertensive with a mild generalized headache. They reported that their eye pain is constant but comes in waves of higher intensity. Differential diagnosis was possible stroke due to right-sided hemianopsia and right-sided ptosis. Patient was admitted and evaluated. Aspirin was administered and blood pressure was monitored prior to discharge.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/11/2021,02/11/2021,0.0,OTH,"Cholecalciferol, Melatonin, Naproxen sodium",None reported,"Arthritis, DDD, GERD, HLD, Resection of meningioma (2017)",,Sulfadiazine,"['Cerebrovascular accident', 'Computerised tomogram head normal', 'Eye pain', 'Eyelid ptosis', 'Full blood count normal', 'Headache', 'Hemianopia', 'Hypertension', 'Metabolic function test', 'Troponin normal']",2,PFIZER\BIONTECH,IM 1035686,FL,77.0,F,Acute Eosinophilic Pneumonia,Not Reported,,Not Reported,Yes,,Not Reported,N,01/08/2021,02/08/2021,31.0,UNK,"Amlodipine, Aspirin, Atorvastatin, Premarin, irbesartan, montelukast, nebivolol, oxybutynin",,,,,"['Bronchoalveolar lavage abnormal', 'Computerised tomogram thorax abnormal', 'Eosinophil count increased', 'Eosinophilic pneumonia acute']",UNK,PFIZER\BIONTECH, 1035723,ID,76.0,M,"FATIGUE, HEADACHE, WEAKNESS ,MUSCLE LOSS IN ARMS AND LEGS, PAIN AND CHILLS, HIGH FEVER",Not Reported,,Not Reported,Yes,8.0,Not Reported,N,01/28/2021,01/29/2021,1.0,PUB,allopurinol 300 mg. atorvastatin 20 mg. losartan 50 mg. metfor metformin 500 mg. aspirin 81 mg. co q-10 200 mg. fish oil 1400mg. omega 3 900 mg.multivitamin men 50+.,"rotator cuff repair, basal cell carcinoma right temple, diabet diabetes, prostate cancer w radiation ending on 1/18/2021.","diabetes, gout, high blood pressure, shingles.",,penicillin,"['Angiogram cerebral', 'Asthenia', 'Blood culture', 'Chest X-ray', 'Chills', 'Computerised tomogram abdomen', 'Computerised tomogram head', 'Computerised tomogram thorax', 'Culture urine', 'Fatigue', 'Headache', 'Lumbar puncture', 'Magnetic resonance imaging brain', 'Muscle atrophy', 'Pain', 'Pyrexia', 'Scan with contrast', 'Ultrasound Doppler', 'Urine analysis']",1,MODERNA,IM 1035741,VI,78.0,F,"Patient reports being in her usual state of good health when she presented for COVID19 Vaccination. She reports onset of diplopia without other symptom approximately 45 minutes after vaccination. Later that night she notes onset of full L eye ptosis which resulted in resolution of the diplopia. She was evaluated by ophthalmology the next day, 2/11, and was referred to the ER where she had a brain CT with no acute changes and unremarkable labs. Treatment with Plavix 75mg was initiated. She was evaluated in my office on 2/16 for persistent ptosis of her L eye and her exam is consistent with isolated third nerve palsy. Diabetes and lipid levels are at target.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/10/2021,02/10/2021,0.0,PUB,"Metformin, ECASA, Januvia, glipizide, simvastatin, nifedipine XL, lisinopril-hydrochlorothiazide",None,"Diabetes, HTN, Hyperlipidemia, Osteopenia, Beta-thalassemia trait",,None,"['Computerised tomogram head normal', 'Diplopia', 'Eyelid ptosis', 'IIIrd nerve paresis', 'Laboratory test abnormal']",1,PFIZER\BIONTECH, 1035768,TX,74.0,F,"passed out; urinated on herself; could not sleep; chills; fever; A spontaneous report was received from a consumer concerning a 74 year old female patient who received Moderna's COVID-19 vaccine and experienced loss of consciousness, chills, pyrexia, urinary incontinence and insomnia. The patient's medical history was not provided. Concomitant medication included unspecified blood pressure medications. On an unspecified date, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection. On 02-Feb-2021 the patient received the second of their planned doses of mRNA-1273 (Lot number 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 02-Feb-2020, the patient experienced chills, some fever, and could not sleep. On the morning of 03-Feb-2021, the patient passed out twice and urinated on herself. No treatment information was provided. Action taken with the mRNA-1273 in response to the events was not applicable. The outcome of the events of loss of consciousness, chills, pyrexia, urinary incontinence and insomnia were was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/02/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Chills', 'Insomnia', 'Loss of consciousness', 'Pyrexia', 'Urinary incontinence']",2,MODERNA,OT 1035769,IN,40.0,M,"Pneumonia; A spontaneous report received from a healthcare professional concerning a 40-year-old, male patient who received Moderna's COVID-19 vaccine and developed pneumonia. The patient's medical history provided were, severe developmental disabilities, chronic constipation and allergy induced asthma. No relevant concomitant medications were reported. On 18 Jan 2021, patient received their first of two planned doses of mRNA-1273(Lot number: unknown), for the prophylaxis of COVID-19 infection. On 20 Jan 2021, within 3 days after injection, the patient was hospitalized for pneumonia. Patient received the vaccine because he received supported living services. The reporter was reluctant to agree to him receiving the 2nd dose. Treatment for the event was not provided. Action taken the first dose of mRNA-1273 in response to the event was not reported. The outcome of the event pneumonia was unknown.; Reporter's Comments: This case concerns a 40 year old male subject, with history of allergy induced asthma, among others, who experienced a serious unexpected event of pneumonia after first dose of mRNA1273 (Lot# unknown). Very limited information has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/18/2021,01/20/2021,2.0,UNK,,Asthma; Constipation chronic; Disability NOS,,,,['Pneumonia'],1,MODERNA,OT 1035784,TN,33.0,F,Received 2nd Pfizer dose on 2/5/21 at 0700. On 2/6/21 around 1930 temp was 102 took Tylenol at this time at 2200 temp was 103.7 took Advil at this time. Temp stayed 102-103.7 with Tylenol and Advil round the clock until 2/8/21 around 1300 at this time temp had gone down to 101. Noticed once fever started to drop my left toes started to tingle. Tingling got worse over the next few days until 2/11/21 my whole leg went extremely heavy (could not lift at all). Admitted to hospital 2/12/21.,Not Reported,,Not Reported,Yes,2.0,Yes,N,02/05/2021,02/06/2021,1.0,PVT,None,None,None,,Latex,"['Body temperature increased', 'Borrelia test negative', 'C-reactive protein normal', 'Chest X-ray', 'Computerised tomogram', 'Full blood count normal', 'Limb discomfort', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging spinal', 'Paraesthesia', 'Pyrexia', 'Scan with contrast', 'Swallow study', 'Troponin normal', 'Vitamin B12 normal']",2,PFIZER\BIONTECH,IM 1035794,MI,75.0,F,"Itchy eyes, followed by itching in her mouth and swelling of the back part of her tongue, trouble speaking and swallowing within minutes of receiving the COVID 19 Moderna vaccine. Sent to ER and admitted for overnight observation.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,02/16/2021,02/16/2021,0.0,PVT,Chewable Aspirin Valsartan Prilosec Atenolol Cyanocobalamin,No,Hypertension Pernicious Anemia Hyperlipidemia Gastroesophageal reflux,,Macrobid Clindamycin Bactrim Cipro Oxycodone,"['Aphasia', 'Dysphagia', 'Eye pruritus', 'Oral pruritus', 'Swollen tongue']",1,MODERNA,IM 1035814,AR,49.0,F,"About 3am the next morning I woke up to a loud ringing in both my ear. When I sat up I was very very dizzy. I got up and showered and my feet swelled very bad. I did not feel well but I went to work but the feelings never got better. So on 1/10 Sunday I went to the medical center because I jjust didnt not feel well. The swelling in the lower legs was still there so I was prescribed 20 mg of presnisone for 5 days. The sound changed during the time of the antibotics but after I stopped taking the prednisone the ringing sound came back, my left foot is still numb and my eyes are constantly red and burning even after putting drops in my eyes, I still suffer from headaches and if I turn my head too far left or right I get dizzy still to date. On 1/14 I was given a 60 mg dose of tapered predinosone for 2 week to help elevate the symptoms but it did not work. On 2/12 I saw an ENT specialist who performed a hearing test which did produce minor hearing loss and was diagnosed with having Tinnitis.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/06/2021,01/07/2021,1.0,OTH,no,no,no,,no,"['Acoustic stimulation tests abnormal', 'Deafness', 'Dizziness', 'Eye irritation', 'Full blood count normal', 'Headache', 'Hypoacusis', 'Hypoaesthesia', 'Malaise', 'Ocular hyperaemia', 'Peripheral swelling', 'Tinnitus']",1,PFIZER\BIONTECH,IM 1035837,NH,31.0,M,The day of the vaccine everything was fine sore arm. On the following morning notice rash on the right side of the mouth was flare of shingles on day 7 rash had crusted over. Around 2 more weeks still exp nerve pain right side of the mouth.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/08/2021,01/09/2021,1.0,PVT,No,No,Psoriasis,,Reactions to statin? drugs,"['Herpes zoster', 'Neuralgia', 'Oral mucosal eruption', 'Pain in extremity', 'Scab']",2,PFIZER\BIONTECH,IM 1035841,IL,84.0,F,Death on 2/8/2021 unknown signs and symptoms at time of death; multiple co-morbidities,Yes,02/08/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/08/2021,5.0,OTH,Home Medications Current 2/3/2021: Albuterol-Ipratropium as needed; Allopurinol daily; Aspirin 81mg daily; B complex plus vitamin C daily; Budesonide as needed; Calcitriol 4 times per week; Diphenoxylate-Atropine as needed for diarrhea; Eut,"Diarrhea with Cdiff etiology, seen in the Wound Center on 2/3/2021 for a pressure ulcer; Seen in ER on 1/14 with diarrhea, fatigue, cough and shortness of breath labs revealed BUN 20; Cr 1.68; GFR 29; Alk Phos 152.",AAA with stent; COPD; Dyslipidemia; Hypertension; Kidney Disease; Murmur; Osteoarthritis; Home oxygen use; Stroke; Parkinson's; Former Smoker; Lung Cancer.,,Gluten; NSAIDS; Penicillin; Sulfa,['Death'],1,PFIZER\BIONTECH,IM 1035845,WI,74.0,F,"We were informed by EMS that the patient was found deceased on 2/11/2021 at her home. EMS states she was dead for some time, no medical care given.",Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/11/2021,8.0,PUB,Unknown,"Not sick at time of vaccination, unknown prior.",Unknown,,none,['Death'],1,MODERNA,IM 1035850,NC,67.0,M,Patient woke up on the morning of 2/6 with symptoms of a stroke. Rushed to hospital where clot found in brain. Recovered from initial stroke but then had another major stroke on 2/8 and never recovered.,Yes,02/13/2021,Not Reported,Yes,8.0,Not Reported,N,02/04/2021,02/06/2021,2.0,WRK,Advair 250-50mcg Allegra-D 24 hour 180-240mg Amlodipine 2.5mg Buspirone 10mg Carvedilol 12.5mg Montelukast 10mg Prednisone 20mg Albuterol Zoloft 100mg Spiriva Nasacort AQ,Sinus Infection being treated with steroids and antibiotics,Asthma Allergies Chronic Sinus infections Depression History of heart attack,,Aspirin Erythromycin,"['Cerebrovascular accident', 'Computerised tomogram', 'Echocardiogram', 'Laboratory test', 'Magnetic resonance imaging', 'Neurological symptom', 'Thrombosis']",1,PFIZER\BIONTECH,IM 1035863,IA,50.0,F,"Moderna COVID- 19 Vaccine EUA Pt received Dose 1 of Moderna COVID series 1/23/21. Pt developed difficulty breathing, cough, respiratory problems on 1/28/21. Pt tested positive for COVID 2/1/21. Pt had progressively worsening symptoms such as coughing fits which make her feel like she cannot breath until pt presented to ED 2/5/21. Initial pulse ox was 88% on room air. Pt was started on 2 L nasal cannula oxygen. Pt endorsed fever, chils, SOB, minimally productive repetitive harsh cough, diffuse body aches, fatigue, nausea, vomiting, diarrhea, mild generalized abdominal pain, loss of smell, loss of taste, no skin rash. Pt admitted to hospital. 2/6/21: Pt feeling better than day before. States oxygen is helping. Fever resolved. Continues to feel weak and tired. Recieved convalescent plasma in AM. Started remdesivir in PM. Continued on empiric ceftriaxone for bacterial superinfection coverage. Holding off on dexamethasone due to oxygen requirements of 2 L but plan to start if has increased oxygen needs. Enoxaparin started for DVT prophylaxis. Breo continued. 2/7/21: Pt continued to have significant cough. Pt did not like formulary Breo and pt's daughter brought in her home Symbicort for in-hospital use. Cough improved with benzonatate and dextromethorphan. Requiring 1 L of oxygen. Continued remdesivir, enoxaparin, benzonatate, detromethorphan. No evidence of bacterial pneumonia. 2/8/21: Discharged home with Genesis COVID Safe At Home telehealth program.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/23/2021,01/28/2021,5.0,PVT,Aspirin 81 mg PO QD Atorvastatin 20 mg PO QD Budesonide-formoterol 160-4.5 mcg/inh 2 puffs BID Dexlansoprazole 60 mg PO QD Telmisartan 80 mg PO QD,,Hypertension Obesity H/o bilateral total hip arthroplasty 2/2 childbirth complications Asthma Hyperlipidemia H/o hysterectomy,,NKDA,"['Abdominal pain', 'Ageusia', 'Angiogram', 'Anosmia', 'Aspartate aminotransferase increased', 'Asthenia', 'Blood culture negative', 'Blood gases abnormal', 'Blood glucose increased', 'Blood urea increased', 'C-reactive protein increased', 'COVID-19', 'Chills', 'Cough', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Full blood count', 'Haemoglobin decreased', 'Lung opacity', 'Mean cell haemoglobin concentration decreased', 'Metabolic function test', 'Nausea', 'Oxygen saturation decreased', 'Oxygen therapy', 'Pain', 'Pneumonia viral', 'Pregnancy test negative', 'Productive cough', 'Pyrexia', 'Red blood cell sedimentation rate increased', 'Respiratory distress', 'Troponin normal', 'Urine analysis normal', 'Vomiting', 'White blood cell count decreased']",1,MODERNA,IM 1035866,IL,74.0,M,"Pt died on 2/15/21. On 2/13/21, pt complained of muscle aches.",Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/15/2021,4.0,MIL,"DOXAZOSIN TAB,ORAL 2MG TAKE TWO TABLETS BY MOUTH TWICE A DAY FOR BLOOD PRESSURE DABIGATRAN CAP,ORAL 150MG TAKE ONE CAPSULE BY MOUTH TWICE A DAY LABETALOL TAB 200MG T",None,"Chronic atrial fibrillation [Chronic atrial fibrillation, unspecified] Hyperlipidemia [Hyperlipidemia, unspecified] Benign essential hypertension [Essential (primary) hypertension] GERD - Gastro-esophageal reflux disease [Gastro-esophageal reflux disease without esophagitis] Carcinoma of colon [Carcinoma in situ of colon] Rosacea [ROSACEA]",,Simvastatin Influenza,"['Death', 'Myalgia']",1,MODERNA,IM 1035872,TX,83.0,M,Patient was found unresponsive at 8 am on 2/12; patient was deceased,Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/12/2021,1.0,PVT,None,None,None,,Penicillin,"['Death', 'Unresponsive to stimuli']",2,MODERNA,IM 1035878,MO,88.0,M,Daughter called to report that the patient died on 02/15/2021. No report of symptoms from the vaccine on 02/13/2021,Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/15/2021,2.0,MIL,"Aspirin, Atorvastatin",AIED; CHF; Type 2 DM; HTN; Chronic Renal Failure; Lung CA,See above,,None,['Death'],1,MODERNA,IM 1035897,NE,78.0,F,Patient received her vaccine on 2/2/2021 in the morning. She was observed for over 15 minutes and had no history of any anaphylactic reaction of any sort. She felt fine and went home. 2/15/2021 we were notified by her family that she had passed away on 2/7/2021 at home. The cause of death was stated as myocardial infarct secondary to coronary artery disease. We do not think it had to do with the vaccine administration. The patient had many comorbidities.,Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/01/2021,,PVT,"Xarelto� (20MG Tablet, 1 (one) Oral daily, Taken starting 09/18/2020) Active. Spironolactone� (25MG Tablet, 1 tab Oral daily, Taken starting 01/08/2021) Active. Sertraline HCl� (100MG Tablet, 1 tab Oral daily, Taken starting 12/28/2020) Act",Acute chronic diastolic CHF exacerbation one month prior One oxygen for stage IV COPD,"Diastolic CHF, Stage 3 chronic kidney disease, adrenal adenoma, COPD stage IV, Coronary artery disease with stents, diabetes mellitus, chronic atrial fibrillation, chronic hypertension, osteopenia.",,Jardiance: Caused a yeast injection,"['Condition aggravated', 'Coronary artery disease', 'Death', 'Myocardial infarction']",1,PFIZER\BIONTECH,IM 1035943,CA,67.0,M,Patient had no reaction at the time of vaccination. Waited the required 15 minutes and was allowed to go home.,Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/13/2021,2.0,PVT,,,Incomplete Quadriplegic. Wheelchair bound after accident where he sustained brain damage after being knocked over by a wave and hitting his head on a sand swell.,,,['Death'],2,PFIZER\BIONTECH,IM 1035950,OH,78.0,M,Patient found deceased at home on 2/15/2021. There was no known cause of death with no significant medical history.,Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,02/15/2021,25.0,PUB,Unknown,none reported,non reported,,No known allergies,['Death'],1,PFIZER\BIONTECH,IM 1035951,RI,60.0,F,"Within 30 seconds: Dry Throat, patient requested water, request was denied. 1 minute after vaccination: Coughing and difficulty breathing 2 minutes after vaccination: Patient refuses EpiPen administration stating she will not go to the hospital and not to call 911. 3 minutes after vaccination: Patient attempts to leave observation area to go use her own EpiPen in her apartment. 4 minutes after vaccination: Patient agrees to EpiPen administration into left leg and 911 is called. 5 minutes after vaccination: Patient continues to cough and clear throat. Patient throws herself out of her chair onto the floor while coughing. 6 minutes after vaccination: Patient hoarsely requests a second administration of EpiPen. EpiPen is administered into right leg. 7-10 minutes after vaccination: Patient is breathing easier however is forcing herself cough. 11 minutes after vaccination: EMTs arrive. Patient's HR: 141 bpm, SpO2: 96% 13 minutes after vaccination: Patient's SpO2: 99% 18 minutes after vaccination: Patient goes outside with EMTs 20 minutes after vaccination: Patient signs ""Against Medical Advice"" form - refusing to go to the hospital 22 minutes after vaccination: Patient is walked by to her apartment by EMTs.",Not Reported,,Yes,Not Reported,,Not Reported,U,02/16/2021,02/17/2021,1.0,SEN,,,Chronic Obstructive Pulmonary Disease,,Codeine - Anaphylaxis Morphine - Anaphylaxis,"['Cough', 'Dry throat', 'Dysphonia', 'Dyspnoea', 'Fall', 'Refusal of treatment by patient', 'Throat clearing']",1,PFIZER\BIONTECH,IM 1035969,NY,87.0,M,Severe left sided chest and back pain,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/10/2021,02/11/2021,1.0,UNK,,,,,NKDA,"['Back pain', 'Chest pain']",UNK,MODERNA,SYR 1035997,IL,59.0,F,"Patient presented to hospital with altered mental status after being found on floor by family. last known normal was day before at 0900. Combative and non-verbal upon arrival to ED. Taken directly to CT. Daughter at bedside in ED, answering all questions on behalf of patient. Reports patient received second dose of COVID vaccine approx 2 weeks prior and had complained of persistent fatigue for 2 weeks since vaccination. Patient combative and uncooperative. Refused to follow instruction, only laying on left side. Febrile upon arrival to ED. Lips dry and cracked, emesis dried to nose. Pupils equal bil and reactive. Patient unable to keep airway secured, ultimately intubated and lumbar puncture done. Many critical lab values including lactic acid, troponin, sodium, glucose, potassium, bilirubin, pH, and WBC. CSF positive for streptococcus pneumoniae. Blood cultures positive for same pathogen. Transferred to a higher level of care.",Not Reported,,Yes,Yes,,Not Reported,U,01/27/2021,02/15/2021,19.0,PVT,Albuterol inhaler PRN Propranolol 60mg daily,None noted per Record,Diabetes HTN,,Lisinopril Statins,"['Aggression', 'Blood bilirubin', 'Blood culture positive', 'Blood glucose', 'Blood lactic acid', 'Blood potassium', 'Blood sodium', 'CSF culture positive', 'Chapped lips', 'Computerised tomogram', 'Culture urine', 'Electrocardiogram', 'Endotracheal intubation', 'Fatigue', 'Full blood count', 'Lip dry', 'Lumbar puncture', 'Mental disorder', 'Metabolic function test', 'Obstructive airways disorder', 'Patient uncooperative', 'Pneumococcal sepsis', 'Protein total', 'Pyrexia', 'Refusal of treatment by patient', 'Speech disorder', 'Streptococcus test positive', 'Troponin', 'Urine analysis', 'Vomiting', 'White blood cell count', 'pH body fluid']",2,MODERNA,IM 1035998,MI,67.0,F,"The first shot caused swelling at injection site. 3 hours after second shot was admitted through the ER because my right arm was ""on fire"" and there was swelling in my left arm. Was admitted for 3 days to the ICU. I have developed a heart murmur.",Not Reported,,Not Reported,Yes,3.0,Yes,N,02/01/2021,02/01/2021,0.0,WRK,"Lisinapril 10mg, Simvasidine 40mg, brotonix 40mg, D3, Garlic, B-100 Complex Vit, B12, Chrominan, CoQ10, Ginger Root, Beta Carotene, Zinc, Sy Isofanonomes, C-100, E-400, Complete Multi Vitamin, Cinnamon, Magnesium, Omega 3, Calcium.",none,Lymphodema,,Penecillin,"['Burning sensation', 'Cardiac murmur', 'Injection site swelling', 'Intensive care', 'Laboratory test', 'Lymphoedema', 'Peripheral swelling']",2,MODERNA,IM 1036030,FL,,F,"Pain in left arm; Passed out; Got dizzy; arm very swollen at the side of the injection; A spontaneous report was received from a consumer concerning her mother, a 52-year-old female patient, who experienced passed out (loss of consciousness), got dizzy (dizziness), arm very swollen at the side of the injection (vaccination site swelling), and pain in the left arm (vaccination site pain). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received her first of two planned doses of mRNA-1273 (lot/batch number not provided) on an unknown date for prophylaxis of COVID-19 infection. On 02 Feb 2021, approximately 1 day and 6 hours prior to the onset of symptoms, the patient received her second of two planned doses of mRNA-1273 (batch number: 012M20A) in the left arm for prophylaxis of COVID-19 infection. On 03 Feb 2021, the patient got dizzy and passed out, her arm was very swollen at the side of the injection, and she had pain in her arm (at 6 to 7 in the morning). Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable. The outcome of the events, passed out, got dizzy, arm very swollen at the side of the injection, and pain in the left arm was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/03/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Dizziness', 'Loss of consciousness', 'Vaccination site pain', 'Vaccination site swelling']",1,MODERNA,OT 1036031,ME,,F,"Anaphylaxis; A spontaneous report was received from a consumer concerning a 61-year-old female patient who experienced anaphylaxis and Anaphylactic reaction. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 27 Jan 2021, 3 minutes prior to onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number 030L20A) intramuscularly (arm location not provided) for prophylaxis of COVID-19 infection. On 27 Jan 2021, within 3 minutes, the patient was hospitalized for anaphylaxis. The patient reported she had never before experienced this type of reaction. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was unknown.; Reporter's Comments: This spontaneous report concerns a 61-year-old female patient who experienced anaphylactic reaction. The event occurred on the same day, 3 minutes after the administration of mRNA-1273 vaccine (Lot number: 030L20A, expiration date: unknown). Treatment administered was not provided and outcome is unknown. Based on the information provided which shows a temporal association a causal association, between the reported events and the administration of mRNA-1273 vaccine cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Anaphylactic reaction'],1,MODERNA,OT 1036032,IL,71.0,F,"Passed out; Unsteady; Slurring her words; Fell into a deep sleep; Tingly in her upper right arm; Feels like equilibrium is off; Legs feel heavy; Fatigue; A spontaneous report was received from a consumer who was also a 71-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passing out (loss of consciousness), unsteadiness (gait disturbance), slurring words (dysarthria), fell into a deep sleep (hypersomnia), tingly feeling in her upper right arm (paraesthesia), felt like equilibrium was off (balance disorder), legs felt heavy (limb discomfort), and fatigue. The patient's medical history included epilepsy. Concomitant products known to have been used by the patient, within two weeks prior to the event, included clonazepam. On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The patient was slurring her words and fell into a deep sleep. It took three individuals to wake her up. The patient wondered if she passed out. She felt tingly in her upper right arm and it felt like her equilibrium was off, and legs were heavy. The patient was very fatigued. Treatments of these events were not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, passing out, unsteadiness, slurring words, fell into a deep sleep, tingly feeling in her upper right arm, felt like equilibrium was off, legs felt heavy and fatigue, was unknown.; Reporter's Comments: This case concerns a 71 year old female subject, with history of epilepsy, who experienced a serious unexpected event of loss of consciousness after first dose of mRNA1273 (Lot# unknown). Concomitant medication included clonazepam. Very limited information has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/03/2021,0.0,UNK,CLONAZEPAM,Epilepsy,,,,"['Balance disorder', 'Dysarthria', 'Fatigue', 'Gait disturbance', 'Hypersomnia', 'Limb discomfort', 'Loss of consciousness', 'Paraesthesia']",1,MODERNA,OT 1036033,FL,,M,"cellulitis (arm got stiff between shoulder and elbow, arm was red and purple, warm to touch,skin was peeling at injection site); A spontaneous report was received from a consumer concerning a 78-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced arm stiffness between the shoulder and elbowthat progressed to the arm becoming red, purple, warm to touch, and the skin was peeling at the injection site. After one week the patient went to urgent care and was diagnosed with cellulitis. The patient's medical history was not provided. No relevant concomitant medication was reported. On 12 Jan 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 012L20A) intramuscularly for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient experienced arm stiffness between the shoulder and elbowthat progressed to the arm becoming red, purple, warm to touch, and the skin was peeling at the injection site. After one week the patient went to urgent care and was diagnosed with cellulitis. The patient was treated with an unspecified antibiotic, Benadryl, and Tylenol. Action taken with the mRNA-1273 in response to the event was not reported, however, the patient's primary care physician advised the patient not to take the second dose of the vaccine. The outcome of the event, cellulitis, was considered not resolved on an unkniwn date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/15/2021,3.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Vaccination site cellulitis'],1,MODERNA,OT 1036047,NY,74.0,M,"Short version The patient has long-standing health issues. The patient received the first dose of Moderna COVID-19 vaccine on 1/16/2021 (unknown location). The patient suffered an event in his home on 1/24/2021. CPR and treatment was begun and he was transported to the ED. He was pronounced dead in the ED at 0846. Long version 70-year-old male with past medical history of CAD with pacemaker, A. fib, COPD, hypertension/hyperlipidemia presenting in cardiac arrest. 911 call at 0724. Per EMS, patient was witnessed by family to have seizure-like activity and then collapsed and became unresponsive. Patient was noted by family to be pulseless and CPR was started right away. Patient received two doses of epi by police were on scene first (AED defibrillation x2) and six doses of epi (plus 6 more AED shocks) by EMS when they arrived. Patient had CPR performed for 45 minutes prior to arriving at the hospital. On route, patient had episodes of paced rhythm and V. fib. Patient received one amp of bicarb and one amp of calcium en route. Patient also received 300 mg of amiodarone en route. Arrived in ED at 0810 Patient received ongoing compressions, shocks and additional medications (epinephrine x6, lidocaine IV, sodium bicarbonate) until time of death called at 0846 in the ED.",Yes,01/24/2021,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/24/2021,8.0,UNK,acetaminophen (TYLENOL) 325 MG tablet Apixaban (ELIQUIS) 5 MG TABS tablet atorvastatin (LIPITOR) 40 MG tablet B-Complex TABS cetirizine (ZYRTEC) 10 MG tablet Chlorhexidine Gluconate (BIOPATCH PROTECTIVE DISK/CHG) (Dressing) MISC Cholecalcif,Hospitalized 12/20 - 12/24/2020 Discharged to home with home care services Hospital Course 12/20 - 12/24/20: 74-year-old male with multiple medical problems presented to the ED with sudden shortness of breath and some palpitations. He was seen in the emergency room after being transported to the ED on CPAP was found to be febrile to 101 tachycardic tachypneic put on BiPAP in ED. EKG showed atrial flutter with left bundle branch block no ST segment elevations COVID-19 was negative RSV and flu was negative chest x-ray showed pneumonia in the right lower lobe. Subsequent chest x-ray showed bilateral lower lobe airspace disease consistent with pneumonia Patient also had a CT abdomen in the ED showing left pleural effusion . The CT report is attached which also showed a right renal cyst with calcification and needs to be followed up in 6 months with a renal protocol CT rest of it was negative. He was started on supplemental oxygen IV antibiotics. Patient was started on Rocephin and azithromycin is significantly improved but off the oxygen and is very eager to leave today patient also had an echocardiogram which revealed an EF of 55 to 60% LV wall motion was normal left atrium was severely dilated. Status post bioprosthetic aortic valve replacement which was in place. He was continued on Eliquis During his hospital course there were no complications. Discharged home today with follow-up. I have elected to send him home on 5-7 days of Levaquin patient reports he is does not tolerate Augmentin well �,"Anxiety � ? Atrial fibrillation � ? CHF (congestive heart failure) � ? COPD (chronic obstructive pulmonary disease) � ? Coronary artery disease � ? Diabetes mellitus, type II � ? Gangrene of toe of left foot � � ? GERD (gastroesophageal reflux disease) � ? Hyperlipidemia � ? Hypertension � ? Insomnia � ? Myocardial infarction Oct 2012 ? Osteoarthritis � ? Peripheral vascular disease",,penicillin diazepam,"['Cardiac arrest', 'Cardiac assistance device user', 'Death', 'Pulse absent', 'Resuscitation', 'Seizure like phenomena', 'Syncope', 'Unresponsive to stimuli']",1,MODERNA, 1036052,NJ,36.0,M,"S&S: ""not 100%"", leg pains, lumbar pain, stiff neck, short-term memory loss; Vital signs were stable; denies vision changes, H/A (nonretractable to meds), balance changes, weakness, speech abnormalities. Tx: Patient educated on post COVID-19 syndrome, Tylenol for pain, pseudoephedrine for congestion, labs for Liver enzymes, discussed possible neurology referral, follow-up w/ PCM on 2/4/2021 (14 days after initial visit).",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/04/2021,01/21/2021,17.0,MIL,Simvastatin 40mg daily Multi Vitamin Vitamin C Fish Oil Tylenol,COVID-19 positive (6Dec2020),Nonalcoholic steatohepatitis (2016) Asthma (1994) Dyslipidemia,,NKDA,"['Alanine aminotransferase increased', 'Amnesia', 'Aspartate aminotransferase increased', 'Asthenia', 'Back pain', 'Balance disorder', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bilirubin normal', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine normal', 'Blood glucose normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea normal', 'Carbon dioxide normal', 'Headache', 'Lipids normal', 'Liver function test', 'Metabolic function test', 'Musculoskeletal stiffness', 'Pain in extremity', 'Protein total normal', 'Respiratory tract congestion', 'Speech disorder']",1,PFIZER\BIONTECH,IM 1036074,MI,50.0,F,"Patient had an allergic reaction after the vaccine . Onsite EMS was called vitals were taken BP 162/88 99% O2 room air HR 86. Patient was treated, Transported by the EMS to the hospital.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/27/2021,01/27/2021,0.0,PUB,,,,,Allergy status to penicillin,['Hypersensitivity'],1,MODERNA,IM 1036087,NJ,29.0,F,"Difficulty breathing- received EpiPen dose, patient was able to breath normally again Shortly thereafter patient was witnessed to have seizure like activity, EMS was called and administered Ativan and Benadryl in route to ED",Not Reported,,Not Reported,Yes,,Not Reported,U,02/16/2021,02/16/2021,0.0,PVT,,,,"Influenza vaccine- unsure of exact details, pt reported that they now receive the Egg Free formulation","Aspirin, Ibuprofen, Latex, Penicillins, Sulfa","['Anaemia', 'Computerised tomogram head', 'Computerised tomogram head normal', 'Dyspnoea', 'Full blood count abnormal', 'Seizure like phenomena']",1,PFIZER\BIONTECH,IM 1036098,AR,77.0,M,Patient received the vaccine on 1/31/2021. Patient complained of bleeding 2/7/2021. Went to clinic where labs were conducted. Patient had an INR of 12. Previous INR results were normal prior to vaccination. Patient was also diagnosed with UTI and given antibiotics. Patient was encouraged to go to ER. Patient died on 2/12/2021.,Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,01/31/2021,02/07/2021,7.0,PVT,"coumadin 5 mg, clopidogrel 75 mg, atorvastatin 20 mg, citalopram 10 mg, levothyroxine 75 mcg, lisinopril-hctz 20-12.5 mg, melatonin 5 mg",,Hypothyroidism; History of coronary artery stent placement; Essential hypertension; Current use of long term anticoagulation,,NKDA,"['Death', 'Haemorrhage', 'International normalised ratio increased', 'Urinary tract infection', 'Urine analysis abnormal']",1,MODERNA,IM 1036099,WI,60.0,F,"Had the vaccine on Wed and then Thursday and Friday had 101.0 temp. By Saturday feeling better. Saturday evening began feeling itchy and painful nerve pain throughout my body. Finally went to ER on Sunday evening and kept as inpatient until Tuesday 2/16. I was also on an antibiotic for an infection and Dr. feels that this was the primary source of my reaction, but not sure if it was compounded by the vaccination. It?s been a rough couple of days, but feeling better now.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/10/2021,02/11/2021,1.0,PVT,,,,,,"['Body temperature increased', 'Infection', 'Neuralgia', 'Pruritus']",2,MODERNA,IM 1036172,MD,84.0,F,My Mom received the COVID shot on Friday January 29th. On Friday Feb 5 one week later she suffered a major heart attack and had to be rushed to the hospital. There has not been any heart conditions in her medical history her entire life. The family is wondering is the COVID shot had any thing to cause this and if there have been any other reported cases.,Not Reported,,Yes,Yes,3.0,Not Reported,Y,01/29/2021,02/05/2021,7.0,PVT,none,,Blood pressure medication,,none,"['Atrioventricular block', 'Myocardial infarction']",1,MODERNA,SYR 1036174,,84.0,M,"At midnight developed heart burn, low BP but normal O2; at 4am took Antacid then felt better and BP was normal. Then around 7am asked to go to ER because the discomfort became pain and moved to the side. Went to ER, mild Cardiac issue and at 3pm had heart attack and passed away.",Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,,02/06/2021,02/07/2021,1.0,UNK,,,,,,"['Cardiac disorder', 'Death', 'Discomfort', 'Dyspepsia', 'Flank pain', 'Hypotension', 'Myocardial infarction']",UNK,PFIZER\BIONTECH,IM 1036182,CO,80.0,M,"Patient received 2nd dose of the COVID-19 Pfizer vaccine, was observed in office x 15+ minutes, and released home. Pt and his son exited the building and when they got to the car, the pt shouted out ""oh no!"" and collapsed to the ground. The patient was unconscious experiencing agonal respirations, and unresponsive to painful stimuli. There is an Emergency Room at the same location. Their staff came out and helped to transfer the pt to the ED for further evaluation. It was found that the patient had a known Anterior communicating artery aneurysm (7/28/2017) that seemed to have ruptured. The patient was stabilized and transported to our local hospital and upon arrival, he was effectively comatose with a GCS 3. CT Head notated an extensive subarachnoid and intraventricular hemorrhage most probably related to a bleeding anterior communicating artery aneurysm. Neuro-Interventional Radiologist dictation reads ""Hunt Hess 5 Fisher grade 4 extensive subarachnoid hemorrhage with intraventricular hemorrhage and early hydrocephalus secondary to rupture of a known anterior communicating artery aneurysm. Initial ICP after EVD placement noted to be in the 120s now 68 treatment complicated by aneurysm rerupture after admission and increased volume of blood although large volume of hemorrhage was seen on initial scan and no change in the patient's clinical exam on her scale was noted due to this rerupture. Patient's exam and prognosis are poor giving extensor posturing lack of extraocular movements to doll's maneuver and weak pupillary reflex as well as cough and gag. Follows no commands or instructions at this time with no spontaneous movement on ventilator set at 12 overbreathing at 14-16 at this time without any sedation."" The family opted to discontinue any further treatment to include surgical intervention given the findings. The patient was given comfort care with son and daughter at the bedside. The patient was extubated and expired at 1545h on 2/13/2021.",Yes,02/13/2021,Not Reported,Yes,1.0,Not Reported,N,02/12/2021,02/12/2021,0.0,PVT,Not verified. EMR states 1/4/2021 SINEMET 25-100 mg tablet.,Unknown,"Not verified. Problem list in EMR includes: Cerebellar ataxia Noted 7/28/2017, Parkinson's disease Noted 10/11/2019, Peripheral polyneuropathy Noted 7/29/2017, Lumbar radiculopathy Noted 10/29/2020, Throat clearing Noted 1/22/2018, Oropharyngeal dysphagia Noted 10/11/2019, Aortic ectasia Noted 10/6/2019, Anterior communicating artery aneurysm Noted 7/28/2017, Essential hypertension Noted 7/28/2017, Constipation Noted 10/23/2019, Nocturia Noted 10/11/2019, Dupuytren's disease of palm of both hands Noted 10/11/2019, Alcohol intake above recommended sensible limits with complication Noted 7/29/2017, Major depressive disorder, single episode, mild Noted 10/11/2019, Hoarseness Noted 1/22/2018.",,NKA,"['Agonal rhythm', 'Areflexia', 'Coma', 'Coma scale abnormal', 'Computerised tomogram head abnormal', 'Cough', 'Death', 'Hunt and Hess scale', 'Intracranial aneurysm', 'Intracranial pressure increased', 'Intraventricular haemorrhage', 'Mechanical ventilation', 'Ophthalmoplegia', 'Posthaemorrhagic hydrocephalus', 'Posturing', 'Pupillary light reflex tests abnormal', 'Pupillary reflex impaired', 'Ruptured cerebral aneurysm', 'Subarachnoid haemorrhage', 'Syncope', 'Unresponsive to stimuli', 'Ventricular drainage']",2,PFIZER\BIONTECH,IM 1036186,NC,73.0,M,"Altered Mental Status, Fever, Lethargy",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/13/2021,02/14/2021,1.0,PVT,"Cardura, Tambocor, Lasix, Avapro, Synthroid, Crestor, Coumadin",Hospitalized 11/23/20 to 12/24/20 with heart issues,"HTN, Afib",,none,"['Aspartate aminotransferase increased', 'Blood creatinine increased', 'Blood potassium decreased', 'Blood urine present', 'Chest X-ray normal', 'Lethargy', 'Mental status changes', 'Oxygen saturation decreased', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1036205,MD,29.0,F,Hospital 1/8-01/21/2021. Hospital for pneumonia and sickle cell crisis.,Not Reported,,Not Reported,Yes,13.0,Not Reported,Y,01/05/2021,01/08/2021,3.0,PUB,"Folic acid, Vitamin D",,Sickle Cell Anemia,,,"['Condition aggravated', 'Pneumonia', 'Sickle cell anaemia with crisis']",1,MODERNA,IM 1036211,MN,45.0,M,"complaint of chest pain, patient sent to ER and hospital admission 2/10/21 to 2/11/21. advanced cardiac imaging found old arterial occlusion with collateral perfusion,no stent ,no surgical intervention.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/04/2021,02/10/2021,6.0,OTH,tylenol as needed,FABRY HTN,FARRY,,NKDA,"['Arterial occlusive disease', 'Cardiac imaging procedure abnormal', 'Cardiac perfusion defect', 'Chest pain', 'Intracranial aneurysm']",1,MODERNA,IM 1036231,CA,18.0,F,"H/o sulfa allergy, monitored for 40 minutes, felt well. 15-20 min later called clinic, felt like throat was closing, advised to go to ER, she arrived in ER while I was on the phone with her. Subsequently developed itching. Was treated in ED with Epi-pen, Benadryl and steroids. Home after observation and improvement. Spoke with patient ( at home) next morning, doing well. Has appointment scheduled with allergist.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,WRK,"Prozac, Seroquel","vomited once the day before vaccination, was well at time of vaccination",Depression,,"Sulfa, sulfites","['Pruritus', 'Throat tightness']",UNK,MODERNA,IM 1036262,CO,76.0,M,"Following day after vac. resident had increased lethargy, nausea, altered mental stats, temp 100.1 bp 96./52, hr 107. Sent to er 1/29, returned 1/31 diagnosis systemic inflammatory response syndrome. On 2/1 resident had temp and respiratory distress. Sent to er again. Returned 2/3 with diagnosis CHF. On 2/7 resident sent out again after stat labs and xray. xray showed infiltrates. Returned from er on 2/10 diagnosis acute encephalopathy and metabolic encephalopathy.",Not Reported,,Yes,Yes,8.0,Not Reported,Y,01/28/2021,01/29/2021,1.0,SEN,,,"Dementia, DM, CKD, HTN, metabolic encephalopathy, anemia, urinary retention, hematuria.",,No known allergies,"['Blood urea', 'Body temperature increased', 'Cardiac failure congestive', 'Chest X-ray abnormal', 'Condition aggravated', 'Encephalopathy', 'Full blood count', 'Lethargy', 'Lung infiltration', 'Mental status changes', 'Metabolic encephalopathy', 'Nausea', 'Respiratory distress', 'Systemic inflammatory response syndrome']",2,PFIZER\BIONTECH,IM 1036345,FL,79.0,F,Patient developed lethargy and malaise several hours after vaccine with a low grade fever. The following morning she reported to her husband inability to taste food or drink. She developed nausea and vomiting which persisted from 1/30/21 through her death. She was found deceased in bed by her husband this morning.,Yes,,Not Reported,Not Reported,,Not Reported,,01/29/2021,01/30/2021,1.0,OTH,levothyroxine,none,thyroid issues,,"crab allergy, none others","['Ageusia', 'Death', 'Lethargy', 'Malaise', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 1036361,MA,,F,"Patient passed out without warning (fell) and hit ceramic floor; Patient passed out without warning (fell) and hit ceramic floor; Black eye; bruised extremities; Been ""out of it"" since then; A spontaneous report was received from a consumer concerning a 59 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed out and hit a ceramic floor causing a black eye, bruised extremities, and the patient was been out of it since the event ( feeling abnormal ). The patient's medical history was not provided. No relevant concomitant medications were reported. On 01 Feb 2021, approximately one day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot number 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient passed out without warning and hit a ceramic floor, which cased a black eye, bruised extremities, and the patient has been out of it since the event. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events passed out and hit a ceramic floor causing a black eye, bruised extremities, and the patient was been out of it since the event ( feeling abnormal ) were unknown.; Reporter's Comments: This case concerns a 59 year old female subject, who experienced a serious unexpected event of loss of consciousness after second dose of mRNA1273 (Lot# 028L20A). Very limited information has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,02/02/2021,29.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Contusion', 'Eye contusion', 'Fall', 'Feeling abnormal', 'Loss of consciousness']",2,MODERNA,OT 1036362,NC,68.0,F,"Rash on the injection arm; Retinal bleeding present in the left eye; A spontaneous report was received from a consumer, concerning herself, a 68 years-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced retinal bleeding present in the left eye and rash on the injection arm. The patient's medical history was not provided. Concomitant medications reported included simvastatin. On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot # 032L20A), intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2021, following the vaccination, the patient experienced a rash on the injection arm that had lasted for about a week. Additionally, the patient went for a routine eye exam on an unknown date in Jan 2021 and it was determined that there was retinal bleeding present in the left eye. The rash had subsided at the time of the report, but the retinal bleeding remained the same. Action taken with mRNA-1273 was unknown. The event rash on the injection arm was considered resolved on an unspecified date in Jan 2021. The event retinal bleeding present in the left eye was considered not resolved at the time of this report.; Reporter's Comments: Very limited information regarding these events of unlisted serious event of retinal hemorrhage and non-serious listed event of injection site rash has been provided at this time. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/01/2021,,UNK,SIMVASTATIN,No adverse event (No medical history reported),,,,"['Retinal haemorrhage', 'Vaccination site rash']",1,MODERNA,OT 1036403,WI,48.0,F,"Hemorrhagic stroke, abnormal platelet count, petechai. Patient had my!triple CTs, MRI and angiogram after finding brain bleed. Once released home from brain bleed patient developed petechai, weakness, shortness of breath",Not Reported,,Yes,Yes,4.0,Not Reported,N,01/18/2021,01/19/2021,1.0,PVT,Multivitamin Atorvastatin MorphIne Oxycodone Buspar,none,Hypercholesterolemia anxiety Chronic pain,,sulfa Haladol,"['Angiogram', 'Asthenia', 'Cerebral haemorrhage', 'Computerised tomogram', 'Dyspnoea', 'Haemorrhagic stroke', 'Laboratory test', 'Lumbar puncture', 'Magnetic resonance imaging', 'Petechiae', 'Platelet count abnormal', 'Scan with contrast']",2,PFIZER\BIONTECH,IM 1036418,IL,85.0,M,"ER visit 1/25/21 patient walked into a prompt care and collapsed, witnessed and pulseless CPR with ROSC after 6-7mins, no shock no meds. Awake and speaking upon arrival to ER. 2 plus pitting edema ble ER diagnosis Anasarca, cardiac arrest, hypotension, elevated troponin I levels, Acute kidney injury and syncope. ER notes reveal a syncopal episode in the shower prior to collapse at prompt care. Central line placed and plan to ship to another facility, patient continued to decline despite dopamine and dobutamine expired in ER prior to transfer.",Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/25/2021,4.0,OTH,Meds as of 1/20/21: Aspirin 81 daily; Carvedilol changed to Metoprolol XL; CoQ10 daily; digoxin 3xweek; fluticasone propionate daily; furosemide 80 mg twice daily; Iron 325mg daily; L-Carnitine daily; lisinopril 2.5 daily; Metamucil plus; M,"Outpatient hospital admit 12/20-12/21 with CHF exacerbation; BNP 2510, platelet count 99; total bili 2.3; BUN 26, Cr 1.42 and GFR 47. Repeat labs 12/31/20 BUN 28; Cr 1.52; GFR 44; 1/2/21 total bili 2.6; platelet count 89. PCP visit 1/7 noted pitting edema BLE and wife stated more confused lately diagnosis hypertension, elevated bilirubin, thrombocytopenia and shortness of breath, CXR 1/7 cardiomegaly, central vascular congestion, tiny bilateral pleural effusions and mucous plugging. Cardiologist visit 1/20/2021 with med changes.","Anemia, CABG, apnea; CHF; dysrhythmia; pacemaker/defibrillator; cardiomegaly; heart disease; aortic valve replacement; former smoker; ischemic cardiomyopathy; perivalvular leak of prosthetic heart valve",,No Known allergies,"['Abdominal wall oedema', 'Acute kidney injury', 'Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood creatinine increased', 'Blood potassium increased', 'Blood urea increased', 'Cardiac arrest', 'Central venous catheterisation', 'Computerised tomogram abnormal', 'Death', 'General physical health deterioration', 'Generalised oedema', 'Glomerular filtration rate decreased', 'Hypotension', 'Lung opacity', 'Oedema', 'Platelet count decreased', 'Pleural effusion', 'Pneumonia', 'Pulmonary oedema', 'Pulse absent', 'Resuscitation', 'SARS-CoV-2 test negative', 'Syncope', 'Troponin increased']",1,MODERNA,IM 1036432,GA,49.0,M,Sudden hearing loss on left ear accompanied by fullness in the left ear and muffled sounds.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/05/2021,02/11/2021,6.0,OTH,,,,,Not known,"['Audiogram abnormal', 'Deafness neurosensory', 'Ear discomfort', 'Hypoacusis', 'Magnetic resonance imaging brain normal', 'Sudden hearing loss']",1,PFIZER\BIONTECH,IM 1036437,OH,86.0,M,"Patient is deceased. Family called the pharmacy on 2-17-21 to let us know he would not be coming for his second appointment. When the pharmacist tried to call the family back for more info, the phone number on file doesn't work.",Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,N,01/26/2021,02/17/2021,22.0,PHM,Unknown,None reported,None reported,,NKDA,['Death'],1,MODERNA,IM 1036440,GA,65.0,M,Patient died at home in hospice care from complications of stage 4 bladder cancer,Yes,01/27/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/27/2021,12.0,PVT,"unknown names of medication, chemo medications, HBP, CHF medications",Stage 4 bladder cancer,"Stage 4 bladder cancer, CHF",,None,"['Bladder cancer stage IV', 'Condition aggravated', 'Death']",1,MODERNA,IM 1036455,OH,38.0,F,On February 14th our dayshift staff arrived at work and upon approach to Patient's room approximately 0700 noted her to very warm and flush. Her temp was taken. She was at 103F. On-call nurse was called. Tylenol was advised and recheck. Prior to recheck Patient's roommate came out stating Patient's was shaking. Staff immediately went to her room to find her actively in a seizure of unknown duration. 911 was called d/t the seizure not ceasing/fever. Squad arrived and Patient was still having tremors. Staff followed to the ER. Patient was intubated and placed on a ventilator. Covid test negative. She is currently at Hospital x3 days.,Not Reported,,Yes,Yes,4.0,Not Reported,N,02/12/2021,02/14/2021,2.0,OTH,Aptom 80mg qd Baclofen 10mg tid Ferrous sulfate QOD Lactulose QD Keppra tid Levothyroxine 150mcg qd glycolax QOD Topamax 100mg tid Vitamin D3 qd Fluticasone nasal spray qd,,"CP, Seizure d/o, generalized brain atrophy, dysphagia, gastrostomy, hx hypothermia, bruxism, gingivitis, profound MR",,"sensitive to citrus, lime, strawberries, red food color dye.","['Body temperature increased', 'Condition aggravated', 'Endotracheal intubation', 'Flushing', 'Mechanical ventilation', 'Pyrexia', 'SARS-CoV-2 test negative', 'Seizure', 'Tremor']",2,MODERNA, 1036459,MI,66.0,M,"2nd immun on 2/12 2pm. Noted taste of blood in mouth on 2/14. On Mondya 2/15 sent note to primary about adding a CBC for an already established appointment on Wed. Lab appointment was wet for 2/16 am. The evening of 2/15, my platelet condition worsened starting with profuse bleeding of gums following a waterpik session and subsequent identification of petechia on legs and blisters on month and tongue. I called my hematologist's after hour service and agreed to stick with original testing plan",Not Reported,,Yes,Not Reported,,Yes,U,02/12/2021,02/15/2021,3.0,PVT,hydroCHLOROthiCoazide 25 mg tablet olmesartan 20 mg tablet ascorbic acid (vitamin C) 500 mg tablet omeprazole 20 mg capsule fexofenadine 180 mg tablet GLUCOSAMINE/CHONDROITN/NA/C/SE (JOINT FORMULA ORAL) MULTIVITAMINS (MULTIVITAMIN ORAL),Benign vertigo diagnosed on 2/3 as part of a standard Hypertension office visit check,Hypertension Chronic ITP,,naproxen,"['Dysgeusia', 'Gingival bleeding', 'Oral mucosal blistering', 'Petechiae', 'Platelet count decreased', 'Tongue blistering']",2,PFIZER\BIONTECH,SYR 1036460,IL,90.0,M,death 2-5-21,Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/05/2021,3.0,OTH,,liver cancer,liver cancer,,,['Death'],1,MODERNA,IM 1036463,NY,73.0,M,"FEVER, FATIGUE, SHORTNESS OF BREATH, ACUTE CYANOSIS WITH RESPIRATORY FAILURE REQUIRING INTUBATION (SUCCESSFULLY EXTUBATED 2/17)",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,02/12/2021,02/13/2021,1.0,PVT,"SORIATINE, LOTREL, KLONOPIN, PRADAX, PROLIA, PROZAC, CLARITIN, BYSTOLIC",,"SKIN CANCER, ATRIAL FIBRILLATION, HYPERTENSION, MASTOCYTOSIS",FATIGUE/FEVER,,"['Acute respiratory failure', 'Cyanosis', 'Dyspnoea', 'Endotracheal intubation', 'Extubation', 'Fatigue', 'Pyrexia', 'Respiratory failure']",2,MODERNA,IM 1036479,IL,77.0,M,Fall 2/4 hospital admission 2/7/21 with death on 2/8/2021. Patient continued to decline on Bipap he was a DNR/DNI and family decided on comfort measures and he expired 2/8/2021.,Yes,02/08/2021,Not Reported,Yes,1.0,Not Reported,N,02/03/2021,02/08/2021,5.0,OTH,Allegra daily as needed; Ambien 5mg daily at bedtime; Aspirin 81 daily; Digoxin daily; hydrocodone-acetaminophen 5-325 as needed pain; Pravastatin 20 daily; ramipril 2.5 daily; zoloft 200 daily,"Fell 2/4 and struck abdomen and ribs with large amount bruising Brought to ER 2/7 due to increased shortness of breath since COVID vaccine. Patient was admitted with CHF, hypoxia, possible aspiration pneumonia; NSTEMI (refused transfer for cardiology).",Dementia; CABG; HTN; MI; esophageal varices; Former smoker; liver cirrhosis; absent kidney,,Sulfa and vicodin,"['Abdominal injury', 'Acute myocardial infarction', 'Bilevel positive airway pressure', 'Blood alkaline phosphatase increased', 'Blood creatinine increased', 'Blood lactic acid decreased', 'Blood urea increased', 'Brain natriuretic peptide increased', 'Cardiac failure congestive', 'Chest X-ray abnormal', 'Chest injury', 'Computerised tomogram normal', 'Contusion', 'Death', 'Dyspnoea', 'Fall', 'General physical health deterioration', 'Glomerular filtration rate decreased', 'Hypoxia', 'Lung opacity', 'Platelet count decreased', 'SARS-CoV-2 test negative', 'Troponin I increased']",1,PFIZER\BIONTECH,IM 1036480,IL,,M,Patient passed away on 2/2/21 after being admitted on 1/31/21 after receiving COVID19 Moderna Vaccine on 1/26/21. On initial report to the hospital patient reported having a cough for over 2 weeks (starting approx. 1/17/21). He had a postive COVID19 PCR on 1/31/21. Intubated on 1/31/21 and passed away on 2/2/21,Yes,02/02/2021,Not Reported,Not Reported,,Not Reported,N,01/26/2021,02/02/2021,7.0,PUB,"amlodipine, aspirin, levothyroxine, losartan, metformin, metoprolol, pravastatin, polyethlyene glycol",had a cough since 2/17/21,"diabetes type 2, hypertension, hypothyroid, hyperlipidemia, MRSA,",,Sulfa causes a rash,"['COVID-19', 'Cough', 'Death', 'Endotracheal intubation', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1036485,ME,73.0,M,"Transverse myelitis with GAD enhancing lesion on MRI C3-C5. Strength was 5/5 symmetrically in the lower extremities, but he had significant weakness in the upper extremities left worse than right. Generally 4-/5 proximally on the right, 4/5 distally; left deltoid, biceps, triceps were 2-3/5, 4-/5 at the wrist and hand. Sensation is largely impaired on the right in a patchy distribution to light touch, temperature, pinprick, vibratory (impaired significantly on the right) and proprioception. Romberg testing was positive.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,02/03/2021,02/14/2021,11.0,WRK,Rivaroxaban metoprolol atorvastatin,None,hyperlipidemia atrial fibrillation GERD,,NKDA,"['Intervertebral disc disorder', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging spinal', 'Muscular weakness', 'Myelitis transverse', 'Paraesthesia', 'Romberg test positive']",1,MODERNA,IM 1036498,AK,64.0,F,"According to the information I have gathered, she became dizzy, nauseated, vomiting later in the day. This continued for nearly two weeks. She then presented to an emergency room and was diagnosed with a cerebellar stroke that likely started on the same day as her vaccine per that physicians report.",Not Reported,,Yes,Yes,4.0,Not Reported,N,01/26/2021,01/26/2021,0.0,PVT,humira vitamin d restasis erythromycin opthalmic flonase folic acid lisinopril c hctz plaquenil synthroid methotrexate rybelsus zocor,unk,anemia RA HTN cataracts DM2 Hypothyroid,,doxycycline compazine PCN phenergan,"['Blood test', 'Cerebellar stroke', 'Computerised tomogram abnormal', 'Dizziness', 'Magnetic resonance imaging abnormal', 'Nausea', 'Vomiting']",1,MODERNA,IM 1036499,SD,84.0,F,"Patient reports her symptoms started on 2/16/2021 with fevers, generalized weakness, mild disorientation, and dizziness when she presented to the ER.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/15/2021,02/16/2021,1.0,PVT,"losartan, zinc sulfate, carBAMazepine, metoprolol tartrate, triamcinolone, atorvastatin, Synthroid, alendronate, multivitamin, cholecalciferol, vitamin D3, CALCIUM",cellulitis after first COVID injection,"disease of tricuspid valve, hyperlipidemia, HTN, osteopenia, CAD, hypothyroidism","Age 84, Moderna COVID vaccine 1st dose, red, warm arm at injection site that extend to the elbow and shoulder. Flu vaccine in 19","Celebrex, egg","['Asthenia', 'C-reactive protein', 'Disorientation', 'Dizziness', 'Full blood count', 'Metabolic function test', 'Pyrexia', 'SARS-CoV-2 test']",2,MODERNA,IM 1036517,,64.0,F,"Right after the vaccine was administered, started with a cough that did not improve for the next few minutes. Needed respiratory therapy",Not Reported,,Not Reported,Yes,,Not Reported,U,02/17/2021,02/17/2021,0.0,PVT,NO,NO,NO,,"berries, cherries, red dye","['Cough', 'Immediate post-injection reaction', 'Oxygen therapy']",1,PFIZER\BIONTECH,IM 1036519,IN,65.0,M,"Received first SARS-CoV2 vaccination yesterday at local store Experienced new symptoms of chills, nausea as well as worsening from baseline dyspnea at night. Wife states he had rough morning breathing and had sudden loss of consciousness and unresponsiveness and failed to respond to bystander CPR. He expired at his home.",Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,PHM,"Albuterol-ipratropium, warfarin, hydrochlorothiazide-triamterene, budesonide-glycopyrroltate-formoterol, atorvastatin.",,"Severe COPD, cor pulmonale, history of pulmonary embolism, chronic hypoxemic respiratory failure.",,NKDA,"['Chills', 'Death', 'Dyspnoea', 'Loss of consciousness', 'Nausea', 'Resuscitation', 'Unresponsive to stimuli']",UNK,UNKNOWN MANUFACTURER, 1036522,GU,72.0,M,"Patient had vaccine on the 12th, Stelara shot on 15th, and symptoms of diffuse erythroderma on the 16th. Seen in ER on 18th and admitted for further treatment.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/12/2021,02/16/2021,4.0,PVT,"Stelara, amlodipine, aspirin, paroxetine, buspirone",Psoriasis Had COVID-19 in November of 2020,"Psoriasis, Gout, Hypertension, Diabetes",,"Zoloft, Ambien, Lisinopril, Gabapentin",['Dermatitis exfoliative generalised'],1,PFIZER\BIONTECH,IM 1036532,MA,93.0,F,Patient was found unresponsive the following day and then pronounced deceased,Yes,02/16/2021,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/16/2021,1.0,SEN,,,,,,"['Death', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,SYR 1036544,NC,67.0,M,Immune thrombocytopenia,Not Reported,,Not Reported,Yes,,Not Reported,N,02/05/2021,02/09/2021,4.0,PUB,None,Covid-19 on 01/01/2021,Hypertension,,No Known Allergies,"['Blood smear test', 'Full blood count', 'Immune thrombocytopenia']",1,MODERNA, 1036585,RI,63.0,F,"Patient called EMS approximately 1pm on 2/15 with complaints of generalized weakness. Upon arrival EMS found her to be diaphoretic and she had a witnessed syncopal episode with question of v-fib and seizures. She became unresponsive and had no pulse. CPR was begun and she was transported to ED. She remained asystole throughout. CPR was initially continued in the ED for approximately 30 minutes and then stopped with Time of Death noted at 13:27. ED notes noted ""suspect given history that patient experienced massive MI, PE or ruptured AAA"". Death certificate notes indicate ""signficant conditions contributing to death after cardiac arrest; ASCVD"".",Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/15/2021,2.0,WRK,"Metformin, Fenofibrate, Simvastatin, Terazosin",Unknown at this time; nothing noted on vaccine screening form,"Essential HTN, Mixed hyperlipidemia, Diabetes Type 2, Osteoarthritis, Heart Murmur,",,None,"['Aortic aneurysm', 'Arteriosclerosis', 'Asthenia', 'Cardiac arrest', 'Death', 'Hyperhidrosis', 'Myocardial infarction', 'Pulmonary embolism', 'Pulse absent', 'Resuscitation', 'Syncope', 'Unresponsive to stimuli']",2,MODERNA,IM 1036591,PA,81.0,M,"Patient received vaccine on 2/8 at 2:50pm. On 2/9 at 10am, patient was found unresponsive. EMS noted R gaze preference and L sided contracture. Patient was intubated and symptoms resolved when given Versed. Concern for seizure activity.",Not Reported,,Yes,Yes,8.0,Not Reported,Y,02/08/2021,02/09/2021,1.0,PVT,"Norvasc, Lipitor, Xarelto, Zetia, omeprazole",,"HTN, HLD, DM",,No known allergies,"['Electroencephalogram', 'Endotracheal intubation', 'Gaze palsy', 'Muscle contracture', 'Pneumonia aspiration', 'Respiratory failure', 'Seizure', 'Unresponsive to stimuli']",1,MODERNA,IM 1036634,MD,77.0,F,"Patient had COVID in Sept. Minimal symptoms. Received 1st dose 1/18 without adverse reactions. Second dose on 2/8-had complaints of arm soreness several days after then appeared in usual state of health. On 2/14 @ 2 hours after having lunch, patient was found unresponsive with Respirations 60, pulse 130, PO 84%, blood pressure 105/68. Patient with lots of white foam coming out of mouth. Temperature to 101.3. Patient DNR B and family deferred transfer, wanted comfort measures only. Nursing received order for MSIR. Patient continued with temps in 99-100 range with tylenol suppositories. Patient passed on 2/16.",Yes,02/16/2021,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/14/2021,6.0,SEN,"buspar, depakote, keppra, norvasc, synthroid, zoloft",none,"HTN, dementia, Downs syndrome",,NKDA,"['Body temperature increased', 'Death', 'Foaming at mouth', 'Pain in extremity', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH, 1036647,MD,84.0,F,"On Monday, 15 February my mother in law suffered a stroke. She has been hospitalized since the stroke at Hospital.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/12/2021,02/15/2021,3.0,OTH,"Medicine for high blood pressure, one for high cholestrol and one for anxiety.",None,None,,None,['Cerebrovascular accident'],2,PFIZER\BIONTECH,IM 1036653,PA,55.0,F,1/6 vaccination 1/7 I started feeling light headed and dizzy. Chest pressure. Went to ER. Hypertensive. Put on medication. Kept as inpatient; observation.,Not Reported,,Not Reported,Yes,1.0,Not Reported,,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Chest discomfort', 'Dizziness', 'Echocardiogram normal', 'Electrocardiogram normal', 'Hypertension']",1,MODERNA,SYR 1036655,IL,69.0,F,Death on 1/31/2021 multiple comorbidities,Yes,01/31/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/31/2021,18.0,OTH,Doxycycline twice daily; gabapentin daily; multivitamin daily; apresoline daily; cyanocobalamin; ascorbic acid; ergocalciferol; eliquis; nitrostat prn; allopurinol; famotidine; isosorbide; labetalol; tylenol; humalog,"Chronic Stage IV sacral decubitis ulcer infected with necrotic tissue. Inpatient admit 1/14-1/27 for infected decubitis ulcer, osteomyelitis; bacteremia and possible cirrhosis and underwent multiple debridements while hospitalized.",ESRD on Dialysis; heart cath; anemia; bells palsy; CHF; Uterine Cancer s/p hysterectomy; CKD; DM; dyslipidemia; HTN; Obesity; AFib.,,"Captopril, lisinopril and plavix","['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood albumin decreased', 'Blood alkaline phosphatase increased', 'Blood creatinine increased', 'Blood urea increased', 'Death', 'Globulins increased', 'Lymphocyte percentage decreased', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1036670,AK,60.0,M,"On evening of vaccine, patient developed arthralgias,right eye felt irritated, 30% vision loss with blurring . During the night, developed fevers, chills, substernal chest pain with radiation towards his back and bilateral arms. mild SOB. Next day, continued chest pain/angina, worsened with climbing a flight of stairs. Admitted to ED/ICU 2/16, general myalgias, Temp 100.7, CP 1/10 on arrival to ED. Small abrasion to right eye noted after flouroscein stain.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/15/2021,02/15/2021,0.0,PVT,"Lipitor, Brilenta, ASA, NTG. gabapentin",,"CHF, CAD, kidney disease, pulmonary disease, COVID-19 11/23/2020",,NKA,"['Angina pectoris', 'Arthralgia', 'Back pain', 'Blindness', 'Body temperature increased', 'Chest X-ray', 'Chest pain', 'Chills', 'Corneal abrasion', 'Dyspnoea', 'Eye irritation', 'Intensive care', 'Laboratory test', 'Myalgia', 'Pain', 'Pain in extremity', 'Pyrexia', 'Vision blurred']",1,MODERNA,IM 1036675,MI,61.0,F,"61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine (Pfizer) on 1/28/21. Upon arrival to triage she was obviously dyspneic with significantly low oxygen saturations. O2 sats on arrival were 65%, improved to mid 90's with O2 6 liters per NC. Admitting diagnosis: hypoxic respiratory failure post COVID vaccine. Lab work shows an elevation of the BUN and creatinine at 31 and 1.71 which is slightly higher than her usual baseline levels. BNP is elevated at 2 448 with a mildly elevated troponin. Procalcitonin is also elevated. Patient's white blood cell count is 11.07. Full viral panel including COVID-19 is not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, Thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 2/8/2021 and then VV ECMO cannulation on 2/13/2021. EGD done 2/14/2021 as unable to pass the TEE probe during cannulation prior day (unable to complete due to abnormal anatomy). Acute pupil exam change in the early am hours of 2/15/2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. GOL engaged and patient not an organ donation candidate. Therefore discussion with sister at bedside resulted in decision for cessation of life support. Patient expired shortly after support withdrawn and pronounced dead on 2/15/2021 at 11:11 AM.",Yes,02/15/2021,Yes,Yes,11.0,Not Reported,N,01/28/2021,02/04/2021,7.0,PVT,"acyclovir (ZOVIRAX) 200 MG capsule Take 1 capsule by mouth 2 times daily. albuterol HFA (PROVENTIL HFA, VENTOLIN HFA, PROAIR HFA) 108 (90 Base) MCG/ACT inhaler Take 2 puffs by inhalation Every 4 hours as needed for Wheezing (shortness of br",�,"Bilateral Lung �Transplant due to Advanced Lymphoangioleiomymatosis Immunosuppressed status (HCC) Antibody mediated rejection of lung transplant (HCC) Bronchiolitis obliterans syndrome, grade 0P (HCC) Major depressive disorder with single episode, in full remission (HCC) RLS (restless legs syndrome) Chronic insomnia Long term current use of systemic steroids OSA (obstructive sleep apnea) Iron deficiency anemia Bilateral sciatica Pure hypercholesterolemia Hoarseness of voice Memory change Laryngeal stridor Senile nuclear cataract, bilateral Myopia of both eyes Osteoporosis without current pathological fracture, unspecified osteoporosis type Dry eyes, bilateral",,"Voriconazole, NSAIDs","['Blood creatinine increased', 'Blood culture negative', 'Blood urea increased', 'Brain natriuretic peptide increased', 'Cerebral haemorrhage', 'Chest X-ray abnormal', 'Computerised tomogram head abnormal', 'Condition aggravated', 'Culture negative', 'Death', 'Diarrhoea', 'Dyspnoea', 'Endotracheal intubation', 'Immunoglobulin therapy', 'Lung opacity', 'Nausea', 'Oesophagogastroduodenoscopy', 'Oxygen saturation decreased', 'Paralysis', 'Procalcitonin increased', 'Pupillary disorder', 'Pupillary light reflex tests abnormal', 'Respiratory failure', 'SARS-CoV-2 test negative', 'Troponin increased', 'Ventricular drainage', 'Viral test negative', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1036678,PA,67.0,M,Resident did not exhibit any side effects from the vaccine. Staff spoke with him in his room at approximately 7:20am and returned to his room just a few minutes later and he was unresponsive. When the RN got to the room he had CTB. Physician documented heart failure and end stage kidney disease on the death certificate.,Yes,02/16/2021,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/16/2021,2.0,SEN,"Amlodipine bes 5 mg ta 1 tab q am, baclofen 10 mg tab � q am and pm, carvedilol 25 mg 1 tab q am and pm, clonidine hcl 0.3 mg tab q morning, afternoon and evening, escitalopram 20 mg 1 tab q am, floranex tab by mouth 3 times weekly, hydral",pneumonia-recent infection,"chronic kidney disease-stage 4, schizophrenia, heart disease, COPD, hypertensive heart disease with heart failure, myalgia, nonrheumatic aortic valve stenosis",,"hydantoins, lipitor, phenytoin, statins-hmg-coa, reductase inhibitors","['Cardiac failure', 'Death', 'End stage renal disease', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 1036683,NY,94.0,M,cardiac arrest in the home.,Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/17/2021,2.0,PVT,unknown,none,"HTN, DM, aortic stenosis, iron deficiency anemia, hypothyroidism, HLD, atrial fibrillation",,NKDA,['Cardiac arrest'],UNK,UNKNOWN MANUFACTURER,SYR 1036685,MN,77.0,F,"Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Unknown if patient experienced adverse effects 2-13 or 2-14, patient called facility 2-15 reporting body aches and chest pressure and was told by facility to seek medical attention, she passed later that day",Yes,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/15/2021,2.0,SEN,,,,,,"['Chest discomfort', 'Chest pain', 'Death', 'Pain']",2,MODERNA,IM 1036697,IL,69.0,M,"Multiple co-morbidities history of COVID-19 6/8/2020 and 12/28/2020. At time of vaccination fighting osteomyelitis. 1st dose 1/13/21, 2nd dose 2/3/2021 expired 2/8/2021.",Yes,02/08/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/08/2021,5.0,OTH,lactobacillus; amlodipine; ascorbic acid; ativan; augmentin; ferrous sulfate; furosemide; mag oxide; mirtazapine; norco; potassium chloride; MVI; prosource liquid; protonix; sennosides-docusate; seroquel; tizanidine; vancomycin; zinc sulfat,Stage 4 sacral pressure ulcer with osteomyelitis with indwelling urinary catheter and peripherally inserted central catheter. IV Vancomycin,"Neurogenic bladder, traumatic brain injury; metabolic encephalopathy; aphasia; Tourette's; Hypertension; insomnia; apraxia; GERD; Pseudobulbar affect; chronic pain; anxiety; major depressive disorder",,No Known Allergies,['Death'],2,PFIZER\BIONTECH,IM 1036731,NH,88.0,F,"SOB, DOE, oxygen desaturation, nausea. Ems transport to ER for eval",Yes,02/16/2021,Not Reported,Yes,,Not Reported,U,02/04/2021,02/14/2021,10.0,OTH,,"CHF, venous stasis ulcers","HTN, polycythemia vera, anxiety disorder, ataxia, backache unspecified chronicity, hyperlipidemia, seizure d/o, h/o skin cancer, osteoporosis, incontinence, arthralgias, dizziness and giddiness",,"Novacaine, ampicillin, sulfa","['Dyspnoea', 'Dyspnoea exertional', 'Nausea', 'Oxygen saturation decreased']",2,PFIZER\BIONTECH,IM 1036748,IL,83.0,M,"Sent to ER 1/14/2021 due to drop in blood pressure with LOC during dialysis. Imaging revealed right lower lobe pneumonia given script for amoxicillin. According to staff patient was on dialysis had pneumonia and was on hospice, dialysis stopped resulting in death.",Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/18/2021,5.0,OTH,Tylenol prn; aspirin daily; atorvastatin daily; calcium carbonate daily; cholecalciferol twice daily; diltiazem; eliquis; ferrous sulfate; norco; melatonin; miralax; namenda; tamsulosin; tramadol every 6hrs.,"ER visit 1/7 due to fall, CT negative current Dialysis, pneumonia, hospice patient.","DVT, dementia, hep c, hyperlipidemia; occlusion of internal carotid artery; paroxysmal Afib; traumatic brain injury",,,"['Alanine aminotransferase increased', 'Albumin globulin ratio abnormal', 'Aspartate aminotransferase increased', 'Blood albumin decreased', 'Blood alkaline phosphatase increased', 'Blood bilirubin increased', 'Blood creatinine increased', 'Blood pressure decreased', 'Blood urea increased', 'Condition aggravated', 'Death', 'Dialysis', 'Globulins increased', 'Loss of consciousness', 'Lymphocyte percentage decreased', 'Pneumonia', 'Protein total normal', 'White blood cell count increased']",UNK,PFIZER\BIONTECH, 1036753,PA,67.0,F,"Neck pain and stiffness, headache unlike any previous headache, fever, myalgia, somnolence, mental confusion, anorexia, eye pain, photophobia: worst during the first 24 hours after vaccination, but ongoing to present. Feels like meningitis symptoms.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/12/2021,02/12/2021,0.0,PUB,fondaparinux nebivolol,Sjogrens with vasculitis multiple clotting disorders immunodeficency Antiphospholipid Syndrome,see above,,"multiple adverse drug reactions: Zoloft, hydroxychloroquine, simvastatin, ACE inhibitors, metronidazole, prednisone, moxifloxacin, cefpodoxime, all novel oral anticoagulants, heparin, Lovenox, Zocin, lidocaine, EMLA cream, cadexomer iodine, multiple wound covers and topical treatments, multiple antifungals.","['Confusional state', 'Decreased appetite', 'Eye pain', 'Headache', 'Meningism', 'Musculoskeletal stiffness', 'Myalgia', 'Neck pain', 'Photophobia', 'Pyrexia', 'Somnolence']",UNK,MODERNA,IM 1036764,CA,35.0,F,"Lower back pain that then was only localized to the right flank. Worse when breathing. Ibuprofen helped with symptoms a bit. I visited the ED and on US a gallstone was detected, not obstructing ducts but the decision was made to have it removed.",Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/05/2021,01/07/2021,2.0,WRK,None,Crohn's disease,Crohn's disease,,Penicillin- unknown reaction Shellfish- anaphylaxis,"['Back pain', 'Blood test', 'Chest X-ray', 'Cholelithiasis', 'Coagulation test', 'Computerised tomogram', 'Flank pain', 'Full blood count', 'Liver function test', 'Metabolic function test', 'Pain', 'Ultrasound abdomen abnormal']",1,MODERNA,IM 1036767,CA,79.0,F,"4 seizure type episodes (including shaking, eyes rolling back for about 15-30 seconds long) after being moved out of bed - lasted 4 days Fever up to 102.5 - lasted 5 days Could not stand - 8 days Body aches - 8 days Could not walk - 9 days Weakness - on going since vaccine Shaking - on going since vaccine",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/28/2021,01/28/2021,0.0,OTH,"BASAGLAR 100 UNIT/ML KWIKPEN INSULIN PEN ? 21 units JANUMET XR 50-1,000 MG TABLET, ER MULTIPHASE ? � tablet",,"Alzheimers Disease, Diabetes type 1, hypothyroidism",,Penicillin,"['Asthenia', 'Blood test normal', 'Computerised tomogram normal', 'Dysstasia', 'Electroencephalogram', 'Eye movement disorder', 'Gait inability', 'Magnetic resonance imaging normal', 'Pain', 'Pyrexia', 'Seizure like phenomena', 'Tremor', 'Urine analysis normal']",1,PFIZER\BIONTECH,SYR 1036770,OH,90.0,F,Feb 10th died in her sleep. No apparent reason.,Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,02/10/2021,22.0,SEN,generic multi vitamin,none,"none, very healthy",,none,['Death'],1,MODERNA,SYR 1036787,MN,78.0,F,passed away 2 days after vaccine was given,Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/05/2021,2.0,SEN,,,late stage dementia,,none,['Death'],2,MODERNA,IM 1036820,CA,66.0,M,"I got the shot at 5pm. When home and I was relaxing watching tv. At 8pm, my heart was racing very fast and took blood pressure, It was very high, 152/105 pulse 74. I called 24hr nurse on call. She said call 911. Ambulance was on site within 5 minute and transported me to hospital. I was in the ER at least 6 hours, moderating my heart. They said I had an A FIB attack. They got it down and admitted me to the hospital. I also experienced pain in my bladder, I could not urinate. They had to drain it 2 times. I was released from the hospital at 8pm the next day. Any questions, don't hesitate to ask me or my doctor.",Not Reported,,Yes,Yes,2.0,Not Reported,N,02/08/2021,02/08/2021,0.0,PVT,Atorvastatin calcium 10mg (one per day) Atenolol 50 mg (one per day) Amlodipine Besylate (Norvasc) 7.5 mg (one per day) Over the counter multiple vitamins.,none,Under control blood pressure,,Hidromorphine Opiates,"['Atrial fibrillation', 'Bladder pain', 'Blood test', 'Echocardiogram', 'Electrocardiogram', 'Hypertension', 'Palpitations', 'Urinary retention']",1,PFIZER\BIONTECH,SYR 1036832,NY,61.0,F,"Achy sore/heavy muscles (current to date) , fatigue that grew worse daily ( and current to date) , whole body chills that lasted 2-3 hours (until 1/25 and now on occasion) , night sweats ( 1/12-1/25) , diarrhea (1/23 - 1/25), headache (1/25 to current date), dizziness (1/25). On Jan. 25: Went to bathroom around 3:15 p.m. with diarrhea and became woozy so decided to get off of the toilet and sit down on the floor. Husband found me semi conscious on the floor with drool at about 4:10 p.m. He tried to awaken me and found me not lucid, speech was garbled, fragmented responsiveness and could not keep upright position, could not give details to the situation. Husband called 911. Ambulance transported to hospital ER during hospital exams and tests patient was not lucid and this continued for the next 32 hours. EKG, EEG, CT scan, MRI, Blood/Lab work; all tests were negative indicating no seizure , healthy heart, clear brain scan, no stroke, white blood count normal, dehydrated. All tests negative with all doctors unable to find a reason for this situation other than the Moderna vaccine considered highly for the situation. Advised patient not to take the second dose of Moderna.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/09/2021,01/12/2021,3.0,PUB,Buspirone HCL10 mg - 2 tabs a.m. Vitamin D 1.25 mg weekly Alendronate Sodium 70 mg. weekly Flonaze a.m. 1 spray each side CBD oil 1/4 dropper a.m. and p.m.,IBS flare up - dehydrated,IBS Osteoporosis Anxiety,,Codiene - vomit,"['Blood test', 'Chills', 'Computerised tomogram', 'Dehydration', 'Depressed level of consciousness', 'Diarrhoea', 'Discomfort', 'Disorganised speech', 'Dizziness', 'Drooling', 'Dysarthria', 'Electrocardiogram', 'Electroencephalogram', 'Fatigue', 'Gait disturbance', 'Headache', 'Magnetic resonance imaging', 'Mental impairment', 'Myalgia', 'Night sweats', 'Somnolence', 'Unresponsive to stimuli']",UNK,MODERNA, 1036857,IL,67.0,M,"patient had vaccine injected at village health facility experienced ataxic gait for several weeks brought to office by family initial impression cva seen at ER, admitted had myocardial infarction next day treated immediately with balloon and and stent placement of affected artery RCA underwent bypass coronary becuase of more severe disease that could not be treated by cardiologist",Not Reported,,Yes,Yes,13.0,Not Reported,U,01/19/2021,01/20/2021,1.0,PUB,quinipril metoprolol fentanyl hydrocodone,none,hypertension,,none,"['Angioplasty', 'Ataxia', 'Cerebrovascular accident', 'Computerised tomogram head', 'Coronary artery bypass', 'Myocardial infarction', 'Stent placement']",1,MODERNA,IM 1036872,GA,33.0,F,"Vertigo, dizziness, joint pain, rash, foggy brain, inability to speak, think and memorize as normal. Sore throat, fluid in ears and lungs. Muscle weakness, headaches...difficulty walking. Insomnia. Flu like symptoms for 2 weeks after dose2. Nerve pain (shooting sensation down both arms. Difficulty standing for more than a few minutes, light headed. Ear pain, nausea, night sweats and unable to grasp normally. Tingling in face. Numbness in face.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/11/2021,01/11/2021,0.0,WRK,Klonopin,Migraines,Asthma and Migraines,,Codeine and sulfa,"['Aphasia', 'Arthralgia', 'Blood test', 'Computerised tomogram head', 'Dizziness', 'Ear pain', 'Electromyogram', 'Feeling abnormal', 'Gait disturbance', 'Headache', 'Hypoaesthesia', 'Influenza like illness', 'Insomnia', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging spinal', 'Memory impairment', 'Middle ear effusion', 'Motor dysfunction', 'Muscular weakness', 'Nausea', 'Neuralgia', 'Night sweats', 'Oropharyngeal pain', 'Otitis media', 'Pain', 'Paraesthesia', 'Pleural effusion', 'Pulmonary oedema', 'Rash', 'SARS-CoV-2 test negative', 'Speech disorder', 'Systemic lupus erythematosus', 'Vertigo']",2,PFIZER\BIONTECH,IM 1036874,KY,64.0,F,Patient developed pneumonia Admitted to hospital on 12/25. Determined to have pseudomonas bacteremia and passed away on 12/27.,Yes,12/27/2020,Yes,Yes,3.0,Not Reported,N,12/17/2020,12/20/2020,3.0,PVT,,,COPD,,,"['Death', 'Pneumonia', 'Pseudomonal bacteraemia']",1,PFIZER\BIONTECH,IM 1036881,AK,70.0,M,Myocardial Infarction,Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/20/2021,9.0,PVT,Multiple cardiac medications including anticoagulation; medications for chronic lung condition,,"Chronic cardiac conditions, chronic lung. Chronic smoker",,Penicillins,['Myocardial infarction'],1,MODERNA,IM 1036912,KY,51.0,F,"Initial injection site pain for two days. Around day five, both armpits were discolored significantly. On day nine I was in the ER with left side abdominal cramps that was diagnosed after a CT Scan as a splenic infarction caused by a blot clot. I have not had a blot clot previously and have always been healthy with no surgeries or prescription medications except propranolol for anxiety (since the pandemic started).",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/05/2021,02/10/2021,5.0,PUB,Zyrtec,None,None,,None,"['Abdominal pain', 'Blood test', 'Computerised tomogram abnormal', 'Injection site pain', 'Skin discolouration', 'Splenic infarction', 'Thrombosis']",1,MODERNA,SYR 1036922,AZ,62.0,F,Patient tested positive for Covid-19 on 02/15/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/15/2021,10.0,SEN,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1036925,TX,64.0,M,"After vaccination, patient was okay until the 8 minute remaining mark. At this point patient became lethargic, clammy and passed out. Patient was revived with smelling salts, for a few seconds and the faded in and out of conciseness. Sternal rub was preformed in order to attempt to keep patient awake and present. Vital signs where taken, BP was elevated at 155/ 115. Patient was still not coherent at this point patient was team lifted to wheel chair and taken to the ER. Patient remains in the hospital at this time admitted for observation.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/17/2021,02/17/2021,0.0,PVT,Unknown,None,None,,NKA,"['Blood pressure increased', 'Chest X-ray', 'Cold sweat', 'Electrocardiogram', 'Incoherent', 'Laboratory test', 'Lethargy', 'Loss of consciousness']",UNK,PFIZER\BIONTECH, 1036929,AZ,88.0,F,Patient tested positive for Covid-19 on 02/15/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/15/2021,10.0,SEN,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1036935,KY,86.0,F,unkown,Yes,02/10/2021,Not Reported,Yes,17.0,Not Reported,N,01/12/2021,01/25/2021,13.0,SEN,,"Treatment for recent eye procedure. Took blood pressure med, lasix, albuterol inhaler, oxygen at night time, antibiotic eye drops, pain med as needed. Received B12 injection once month. Took folic acid, used nasal spray, probiotic","Diastolic heart failure Edema to lower extremities Anemia Hyperparathyroidism due to rental insufficiency Chronic Kidney disease stg. 3 & 4 Chronic hyponatremia Essential hypertension Hx. of pacemaker, breasts lumpectomy",,Dairy products Tetracycline,['Death'],UNK,PFIZER\BIONTECH,IM 1036941,AZ,84.0,M,Patient tested positive for Covid-19 on 02/15/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/15/2021,0.0,SEN,,,,,"Colchicine, gabapentin, linezolid, morphine, shell fish, colcrys","['COVID-19', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1036956,IL,75.0,M,I had a seizure. My wife found me on the bathroom floor convulsing. I was unconscious for over an hour and a half. I was taken to hospital by ambulance. I have short term memory lost. All of the scans were normal and all my vitals signs were normal . I never had a seizure before and it was not signs of a stoke on the cat scan.,Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/11/2021,02/12/2021,1.0,OTH,AmLodipine 10 mg tablet,None,None,,None,"['Amnesia', 'Computerised tomogram head', 'Computerised tomogram normal', 'Loss of consciousness', 'Seizure']",UNK,MODERNA, 1036989,CA,80.0,F,"This person received the 1st dose COVID-19 vaccine Pfizer @ 08:13am. Then @0930 am, c/o ""feeling something on top of her chest, heaviness of chest"", sweaty hands, clammy, chest pain. Rapid Response Team called at 09:35 am. Transferred to Emergency Room. In ED: Diagnosis included but not limited to STEMI, NSTEMI, unstable angina, anxiety. At 10:04am- based on EKG, code STEMI was called. Consultation with cardiologist. Then the patient was sent emergently to Cath Lab. The patient was admitted to ICU, intensive care, following Cath Lab",Not Reported,,Not Reported,Yes,,Not Reported,N,02/16/2021,02/16/2021,0.0,PVT,Unknown,Unknown,Unknown,,Sulfa,"['Acute myocardial infarction', 'Angina unstable', 'Anxiety', 'Catheterisation cardiac', 'Chest X-ray', 'Chest discomfort', 'Chest pain', 'Cold sweat', 'Electrocardiogram', 'Hyperhidrosis', 'Intensive care']",1,PFIZER\BIONTECH,IM 1036993,IA,73.0,M,"Patient reported at review of questionnaire had headache that day. Temp was taken, 97.8, okay. proceeded. Conversing customer friend in store afterward. When timer went off, said he was fine, he and his wife left. Daughter called to store Wednesday morning, said Pt had passed away Tuesday, that it was unknown the cause, and just wanted to let us know. We did not take down her phone number and last name. The patient was a long time customer.",Yes,02/16/2021,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/16/2021,0.0,PHM,"Known Prescription Meds dispensed at pharmacy: Oxycodone/Acet Prn, Gabapentin, Metoprolol, Pantoprazole, Tamsulosin, Atorvastatin, Clopidogrel, Montelukast, Trazodone, Do not have info on OTC or Dietary supplements",,Hx of migraine headaches,,noted on admin form: Ibuprofen,"['Death', 'Headache']",1,MODERNA,IM 1037040,CT,39.0,F,"Anaphylaxis: After my second dose of the vaccine within 3-5 minutes I stared feeling swelling of the thong, itchy throat, head, neck, sob. I immediately reported my symptoms to the MD that was in the room monitoring the recent vaccinated employees. Immediately he administered 50mg of Benadryl, 20mg of Pepcid, and salbutamol. I was rushed to the ED and stayed there for couple of hours headed back to my unit and then sent home by my manager.",Not Reported,,Yes,Not Reported,,Not Reported,Y,12/22/2020,01/12/2021,21.0,OTH,"vitamin d3, vitamin b12.",,asthma,,"shellfish, tamarinds","['Anaphylactic reaction', 'Dyspnoea', 'Pruritus', 'Swollen tongue', 'Throat irritation']",2,PFIZER\BIONTECH,IM 1037051,CA,77.0,F,"Diarrhea , fatigue on 2/10 Fall 2/12 out to hospital Resident Expired 2/14",Yes,02/14/2021,Not Reported,Yes,2.0,Not Reported,N,02/08/2021,02/10/2021,2.0,SEN,UNKNOWN,"Pyelonephritis, Nephrostomy in 2019","HTN, ASTHMA",,"Ampicillin, Penicillin, shellfish,seafood","['Death', 'Diarrhoea', 'Fall', 'Fatigue']",2,PFIZER\BIONTECH,IM 1037076,NE,89.0,M,"Resident developed increased confusion on 01/30/2021 that may have been related to vaccine or to residents other medical conditions including dementia, anxiety, shortness of breath, history of lung cancer, and COPD. Sustained a fall with fracture and was transferred to Hospital. Surgical intervention performed to repair hip. Resident returned to Skilled Nursing facility. Did not recover after surgery and family chose palliative measures. Resident died/ expired on 02/09/2021.",Yes,,Not Reported,Yes,,Not Reported,N,01/26/2021,01/30/2021,4.0,SEN,"Albuterol, Eliquis, Ativan, Gabepentin, Lasix, & others.","Hx Lung CA, COPD, dementia, A. Fib, Anxiety, edema, SOB","Lung Cancer, COPD, dementia, A. Fib, Anxiety, Edema, shortness of breath, neuropothy of lower limbs, hypertension",,Orange Juice,"['Confusional state', 'Death', 'Fall', 'Hip fracture', 'Hip surgery', 'Laboratory test', 'X-ray']",2,PFIZER\BIONTECH,IM 1037110,NY,68.0,F,"high fever, loss of ability to ambulate, fell on floor. Taken to hospital by ambulance. Low blood pressure, low oxygen, numerous labs were outside of normal limits,, elevated lactic acid. Received methyloredbuise 60mg every 6 hours (I think three times) Admitted on Feb 14th. Discharged on Feb 16th.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/13/2021,02/13/2021,0.0,OTH,"prednisone, synthroid, crestor, xolair, low dose asprin, calcium and vitamin D, Ventolin as needed, advair 500/50, allery shots, reclass infusion, lucentis, amoxicillin (before dentist)",none,"osteoporosis, osteopenia, right wet macular degeneration, eosinophilia",,"sulpha, dilantin, singular, levaquin,","['Blood lactic acid increased', 'Chest X-ray', 'Computerised tomogram head', 'Computerised tomogram thorax', 'Fall', 'Gait inability', 'Hypotension', 'Laboratory test', 'Oxygen saturation decreased', 'Pyrexia', 'Ultrasound scan', 'X-ray of pelvis and hip']",2,MODERNA,IM 1037124,NJ,53.0,M,Patient was at a gym watching his daughter. He slumped over unconscious. EMS was called. He was found to be in fine ventricular fibrillation and resuscitation efforts failed. He was brought to Hospital ED where he was pronounced dead. He had underlying cardiac disease but his family requested I report this event as possibly related to the recent COVID vaccination.,Yes,02/16/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/16/2021,12.0,OTH,Plavix 75 mg daily lipitor 20 mg daily aspirin omeprazole,none,"Coronary artery disease, stent placed GERD",,none,"['Death', 'Loss of consciousness', 'Resuscitation', 'Unresponsive to stimuli', 'Ventricular fibrillation']",1,MODERNA,IM 1037159,,84.0,F,Altered mental status; confusion; TIA (transient ischemic attack),Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/09/2021,02/10/2021,1.0,PVT,,,,,NKA,"['Confusional state', 'Mental status changes', 'Transient ischaemic attack']",1,PFIZER\BIONTECH,IM 1037165,,74.0,M,Chest pain; weakness; fever,Not Reported,,Not Reported,Yes,,Not Reported,,02/10/2021,02/11/2021,1.0,PVT,,,,,"Banana, cashew nut","['Asthenia', 'Chest pain', 'Pyrexia']",2,MODERNA,IM 1037173,,72.0,F,"Acute on chronic congestive heart failure, unspecified heart failure type; Bilateral pleural effusion; COPD exacerbation; COVID-19 virus not detected; Hypoxia; SOB (shortness of breath)",Not Reported,,Not Reported,Yes,,Not Reported,,02/10/2021,02/11/2021,1.0,PVT,,,,,ATORVASTATIN; LISINOPRIL; NAPROXEN; NICOTINE,"['Cardiac failure acute', 'Cardiac failure congestive', 'Chronic obstructive pulmonary disease', 'Dyspnoea', 'Hypoxia', 'Pleural effusion', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 1037207,UT,39.0,F,She had pain in the injection site Tuesday night and then during Tuesday she got worse with nausea and some fever. By Wednesday she was complaining that she could not pee even though she was drinking a lot of fluids. She continued to complain it was the worst she ever felt and then at 0600 Thursday morning she woke us up and said she needed to go to the hospital. We arrived at the hospital just before 0700 and she immediately threw up in the trash can. We went into a treatment room and they took blood and started fluids as she became incoherent. She said she had taken Tylenol so they started a drug to counter that but her liver function was all wrong and they started to look for a hospital that could transplant a liver. She was air evade about 0930 to Medical center and just over 30 hours latter she was dead. There is a pending autopsy. She was a healthy 39 year old mother who got the shots because she worked as a surgical tech and she was the single mother of a 9 year old little girl.,Yes,02/05/2021,Not Reported,Yes,2.0,Not Reported,N,02/01/2021,02/02/2021,1.0,PVT,"birth control, and she did do botox","none,",trigeminal neuralgia - has been in remission since she started doing botox,,sulfa drugs,"['Death', 'Incoherent', 'Injection site pain', 'Liver function test abnormal', 'Malaise', 'Nausea', 'Pyrexia', 'Urinary retention', 'Vomiting']",2,MODERNA, 1038633,,85.0,M,"Moderna COVID vaccine administered 2/9/21. Patient expired in home on 2/10/21, at around 2100. Patient had h/o CVA in2001 with long standing sequelae. On day of administration, team attempted to draw lab specimen with vein finder, but patient was possibly Narrative: Moderna COVID vaccine administered 2/9/21. Patient expired in home on 2/10/21, at around 2100. Patient had h/o CVA in2001 with long standing sequelae. On day of administration, team attempted to draw lab specimen with vein finder, but patient was possibly dehydrated. CG/wife reported to APRN on 2/10/21, patient was sleeping and snoring and then began to sleep more quietly. She checked on patient and found that he had no pulse and had passed away",Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/10/2021,1.0,OTH,,,,,,"['Death', 'Pulse absent']",UNK,MODERNA,IM 1037277,CA,65.0,F,"starting February 5, I had mild swelling in the entire left leg treated with ice and anti-inflammatories. There was no redness, swelling, or pain at injection site. Symptoms seemed to be slowly subsiding. However, Thursday 2/11/21, I had a small patch of itchy, (but not painful) red rash on back of left thigh. By Thursday evening it had doubled in size. Friday am (2/12/21) it was a little bigger still. Then by Friday after work, my entire left leg was moderate to severely swollen and the rash covered a large part of the back of right thigh and was beginning to spread to the back of left calf. Friday evening, I visited Urgent Care. The doctor there was concerned about a possible DVT and sent me to the ER. At ER, an ultrasound revealed no DVT. At no time did I have a fever. The ER doctor admitted me to the hospital where I remained until the afternoon of Monday, February 15. During hospital stay, I was treated with IV Vancomycin twice per day. That helped quite a bit to reduce rash and swelling but it remains at a mild level. I am currently Doxycycline Hyclate 100 mg every 12 hours for 7 days. I took the first dose of the oral med at the hospital on the day of discharge.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/03/2021,02/05/2021,2.0,PUB,"Meloxicam 7.5 mg daily: Amlodipine-Benazepril 5/20 mg; Protonix; generic for Protonix 40 mg: generic for Lunesta 3 mg daily. Tylenol PM 2 per night. Supplements as follows: Vitamin D 10,000 I.U.; Vitamin K2 45 mg; Vitamin A 3000 mcg; Stront",None,Rheumatoid arthritis since childhood and monthly eye injections for a retinal corneal vein occlusion diagnosed in 9/20,,Humera and Embrel,"['Blood test', 'Peripheral swelling', 'Pruritus', 'Rash', 'Rash erythematous', 'Ultrasound scan normal']",1,MODERNA,IM 1037719,NC,86.0,M,"bleeding internally in small intestine; cut Eliquis in half; rash on shoulder and neck; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-013205) license party for apixaban (ELIQUIS). This case was received via Pfizer Inc (Reference number: 2021125505) on 05-Feb-2021 and was forwarded to BMS on 08-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of SMALL INTESTINAL HAEMORRHAGE (bleeding internally in small intestine) in 86-year-old male patient who received apixaban (Eliquis) tablet for an unknown indication. The occurrence of additional non-serious events is detailed below. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for Prevention. Product or product use issues identified: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (cut Eliquis in half). Concurrent medical conditions included Gout (diagnosed two or three years ago). On an unknown date, the patient started Eliquis (Oral) 2.5mg half tablet by mouth twice daily. On 07-Jan-2021, the patient started Covid-19 Vaccine (Intramuscular) intramuscular injection in right arm. Further treatment periods at the same dose started on 01-Feb-2021. In January 2021, the patient experienced RASH (rash on shoulder and neck). On an unknown date, the patient experienced SMALL INTESTINAL HAEMORRHAGE (seriousness criterion medically significant). The patient was treated with salicylic acid (Eucerin [Salicylic Acid]) for Rash. The action taken with Eliquis(Oral) was unknown. At the time of the report, SMALL INTESTINAL HAEMORRHAGE outcome was unknown and RASH did not resolve. Cardiologist recommended patient to take apixaban for palpitation of the heart that he has every so often. Eliquis at 2.5mg tablet twice a day and then patient found out he was bleeding to death, clarifies he was bleeding internally in his small intestine. So he cut his Eliquis in half and he was currently taking half of 2.5mg tablet twice a day. He got the Pfizer covidl19 shot. He has developed a rash on his shoulder and neck. He also stopped using his laundry soap since he was not sure if it was his laundry soap. For Eliquis(Oral), the reporter did not provide any causality assessments.; Sender's Comments: BMS Medical Evaluation Comment: This patient had small intestine hemorrhage while on apixaban. Based on the anticoagulant nature of apixaban, its contributory role in small intestine hemorrhage is considered possible.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/01/2021,,UNK,DILTIAZEM XR; ULORIC; PANTOPRAZOLE; ELIQUIS,Gout (diagnosed two or three years ago),,,,"['Rash', 'Small intestinal haemorrhage', 'Wrong technique in product usage process']",UNK,UNKNOWN MANUFACTURER,OT 1037720,,,U,"Suicide; A spontaneous report was received from a consumer concerning a patient, of unknown age/gender, who received Moderna's COVID-19 vaccine and experienced suicide. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On unknown date, the patient received mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date the patient experienced suicide. Treatment information was not provided. Action taken with the mRNA-1273 in response to the event was not reported. The patient died on unknown date. The cause of death was reported as suicide. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Suicide",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Completed suicide'],1,MODERNA,OT 1037721,GA,65.0,M,"unconscious, near death experience; extreme headache while at work; felt like he was walking on water; couldn't eat; couldn't sleep; doesn't remember any of it; couldn't talk; speech was garbled; wasn't understanding or comprehending anything; difficulty breathing; fatigue; muscle pain all over his body; joint pain; chills; nausea; vomiting; he couldn't control his bladder; fever that went up really high; dizziness; Weakness; Two spontaneous cases were received on 02Feb2021 concerning a male patient, 65 years of age. The cases are cross-linked. The reporter stated the patient is their nephew. According to one report, the patient experienced the following symptoms: ""extreme headache while at work"", ""felt like he was walking on water"", ""couldn't eat"", ""couldn't sleep"", ""doesn't remember any of it"", ""unconscious"", ""near death experience"", ""he couldn't talk and speech was garbled"", ""he wasn't understanding or comprehending anything"". According to the other report, her nephew experienced symptoms immediately upon receiving the vaccine. She reported the following symptoms not already mentioned by the first reporter; ""difficulty breathing"", ""chronic headache:, ""fatigue"", ""muscle pain all over his body"", ""joint pain"", ""chills"", ""nausea"", ""some vomiting"", ""couldn't control his bladder"", ""fever that went up really high"", "" lost ability to breathe"", ""dizziness"", ""weakness"", ""Moderna shot is killing him"", and ""he is dying"". The patient's prior medical history include an allergy to Shellfish, previously reported as fish allergy. No other medical history was provided and concomitant product use was not provided by either reports. Prior to the onset of events, the patient received his first of two planned doses of mRNA-1273, (date and batch number not provided), (injection site not provided), for prophylaxis of Covid-19 infection. On ??Jan-2021, shortly after receiving mRNA-1273 immunization, the patient began experiencing the following symptoms: ""extreme headache while at work"", ""felt like he was walking on water"", ""couldn't eat"", ""couldn't sleep"", ""he couldn't talk and speech was garbled"", ""he wasn't understanding or comprehending anything"". At an unknown time later he experienced ""difficulty breathing"", ""lost consciousness"" and was admitted to the hospital ICU on 22Jan-2021. Transport to hospital and name of hospital was not reported. According to the reporters the patient remained in the ICU for eleven days. The following symptoms were reported as occurring during his hospitalization either in the ICU or after transfer to a less acute unit on or about 01-Feb-2021: ""chronic headache:, ""fatigue"", ""muscle pain all over his body"", ""joint pain"", ""chills"", ""nausea"", ""some vomiting"", ""couldn't control his bladder"", ""fever that went up really high"", "" lost ability to breathe"", ""dizziness"", ""weakness"", ""dying"", unconscious for almost a week"". According to the reporters he had CT exams of spine and brain, and heart exams twice on different days while hospitalized but results ""didn't find anything"". No other significant results or details of his hospital stay were reported. As of the report date 02-Feb-2021 the patient remained hospitalized. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were unknown. Company comment: The reported events, ""loss of consciousness"", ""headache"", ""feeling abnormal"", ""weakness"" ""decreased appetite"", ""insomnia"", ""amnesia"", "" aphasia"", ""dysarthria"", ""confusional state"", ""dyspnea"", ""fatigue"", "" myalgia"", ""arthralgia"", ""chills"", ""nausea"", ""vomiting"", "" pyrexia"", ""urinary incontinence"", and ""dizziness"" were possibly related to mRNA-1273.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,Shellfish allergy,Medical History/Concurrent Conditions: Multiple allergies; No adverse event,,,"['Amnesia', 'Aphasia', 'Arthralgia', 'Asthenia', 'Chills', 'Confusional state', 'Decreased appetite', 'Dizziness', 'Dysarthria', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Headache', 'Insomnia', 'Loss of consciousness', 'Myalgia', 'Nausea', 'Pyrexia', 'Urinary incontinence', 'Vomiting']",1,MODERNA,OT 1037722,NY,,M,"Paralysis legs intermittent; Disoriented; Malaise; Fatigue; Fever; A spontaneous report was received from a consumer concerning an 85-year-old, Asian, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever (pyrexia), malaise, fatigue, disorientation, and intermittent leg paralysis (diplegia). The patient's medical history included stroke and hypertension. No relevant concomitant medications were reported. On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K202A) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient experienced symptoms of fever, malaise, fatigue, disorientation, and intermittent leg paralysis. Treatment for the event included acetaminophen. Action taken with mRNA-1273 in response to the events was unknown. The outcome for the event fever and disorientation was reported resolved on 20 Jan 2021.The outcome for the event paralysis legs intermittent was reported resolved on 22 Jan 2021. The outcome for the event fatigue and malaise was reported as resolved on 23 Jan 2021.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/16/2021,01/19/2021,3.0,UNK,,,Medical History/Concurrent Conditions: Hypertension; Stroke,,,"['Diplegia', 'Disorientation', 'Fatigue', 'Malaise', 'Pyrexia']",1,MODERNA,OT 1037723,CA,,M,"cellulitis in the leg; bad chills; flu like symptoms; headache; Nausea; high fever; short breathing; A spontaneous report was received from a consumer, concerning her husband, a male of unreported age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu-like symptoms, headache, bad chills (chills,) nausea, high fever (pyrexia,) short breathing (dyspnea,) and cellulitis in the leg. The patient's medical history was not included. Products known to have been used by the patient were not provided. Prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 041L20) for prophylaxis of COVID-19 infection. On 04 Feb 2021, after the mRNA-1273 vaccine was given, the patient experienced flu-like symptoms, headache, bad chills (chills,) nausea, high fever (pyrexia,) short breathing (dyspnea,) and cellulitis in the leg.Treatment information was not provided. Action taken with mRNA-1273 was not reported. The outcome of the events, experienced flu-like symptoms, headache, bad chills (chills,) nausea, high fever (pyrexia,) short breathing (dyspnea,) and cellulitis in the leg, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,02/04/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical history not provided),,,"['Cellulitis', 'Chills', 'Dyspnoea', 'Headache', 'Influenza like illness', 'Nausea', 'Pyrexia']",UNK,MODERNA, 1037724,OH,80.0,M,"had a sore arm, so sore that he ended in the hospital for 2 days; he couldn�t move his arm; it still hurts and goes into his neck; A spontaneous report was received from a consumer concerning, an 80-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sore arm, he couldn't move his arm, and it still hurts and goes into his neck. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 ([LOT# not provided]) intramuscularly for prophylaxis of COVID-19 infection. The patient's wife stated that the patient had the vaccine and then 5 days later he had a sore arm, so sore that he ended up in the hospital for 2 days (dates not provided). The patient couldn't move his arm and it still hurts and goes into his neck. The patient did not plan on receiving the 2nd dose of the vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events of he ended in the hospital for 2 days, he couldn't move his arm and it still hurts and goes into his neck were not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/27/2021,02/01/2021,5.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Injected limb mobility decreased', 'Neck pain', 'Pain in extremity']",1,MODERNA,OT 1037725,NJ,76.0,M,"bleeding from right ankle / lost a lot of blood; saw a pencil eraser/red looking spot; A spontaneous report was received from a non-healthcare professional (caregiver) concerning a 76 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and hemorrhage and erythema. Medical history included being mentally challenged. Concomitant medication included unspecified cholesterol medication, two unspecified blood pressure medications, baby aspirin, vitamin D, and lorazepam. On 04 Feb 2020, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient experienced bleeding from a pencil eraser red looking spot on the right ankle, had lost a lot of blood. The bleeding had stopped and no treatment was reported. Action taken with the mRNA-1273 in response to the event was not reported. The outcome of the event of hemorrhage was considered resolved. The outcome of the event erythema was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/05/2021,1.0,UNK,BABY ASPIRIN; VITAMIN D NOS; LORAZEPAM,Mental disability NOS,,,,"['Erythema', 'Haemorrhage']",1,MODERNA,OT 1037756,,,M,"Before his 2nd dose, he was diagnosed with COVID and was given bamlanivimab; Before his 2nd dose, he was diagnosed with COVID and was given bamlanivimab; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient received 1st dose of vaccine. Before his 2nd dose, he was diagnosed with COVID and was given bamlanivimab. It was planned to wait 90 days before giving him any additional vaccine. Reporter also asked should patient receive one more dose or restart the series. The outcome of events was unknown. Information about Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1037796,VA,,F,"tested positive for Covid-19 virus; tested positive for Covid-19 virus; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable female consumer(patient). A female patient of an unspecified age received first dose BNT162B2, via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient receive 1st dose 11Jan2021, then experienced tested positive for covid-19 virus on Jan2021 with outcome of unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1037800,GA,,F,"Week later she tested positive for Covid virus.; Week later she tested positive for covid virus.; This is a spontaneous report from a Pfizer-sponsored program Pfizer first connect from a contactable consumer. A female patient of an unspecified age received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration, on 11Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received COVID vaccine on 11Jan2021. A week later she tested positive for COVID virus. Ended up in hospital. Wanting to know when and if she can get next dose of vaccine. The clinical outcome of the event was not reported. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/11/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1037801,AZ,,F,"Inquiring if side effects are from the vaccine. Or if she received covid after the vaccine.; Inquiring if side effects are from the vaccine. Or if she received covid after the vaccine.; This is a spontaneous report from a Pfizer Sponsored program Pfizer First Connect. A contactable registered nurse reported for herself that a female patient of an unspecified age received first and second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse received both doses of covid vaccine shots. She was inquiring if side effects are from the vaccine or if she received covid after the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: received covid. The outcome of the event was unknown. Information on lot/batch number has been requested.; Sender's Comments: Based on the limitedly available information, the lack of efficacy cannot be excluded for vaccine BNT162B2. The case should be reassessed when the administration date of BNT162B2 injection, the test date of SARS-COV-2, medical history and concomitant medication become available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1037805,SC,81.0,F,"Very dizzy/ Light headed; I felt very washed out and thought I was tired/ exhausted; Lethargic; She still has a little weakness; Almost like a flare up of Hashimoto; a scalp problem, but nobody knows what it is/ Whatever she has, the vaccine aggravated it 10 times worse; a scalp problem, but nobody knows what it is/ Whatever she has, the vaccine aggravated it 10 times worse; she was feeling bad; The injection site was red, hard, kind of warm; The injection site was red, hard, kind of warm; The injection site was red, hard, kind of warm; joint pain, knees, feet, even my hands; joint pain, knees, feet, even my hands; It felt like some kind of nerve ending issue; She was also very off balance; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration at left arm on 23Jan2021at a single dose for COVID-19 immunization. Medical history included ongoing Hashimoto's disease; scalp issue; abrasions on her head like eczema; and weight loss. She was diagnosed a couple of years ago with Hashimoto. A thyroid disorder. She is not on a thyroid medication. They have just been watching it to see. She took the shot. For background, the last couple of months the patient has had abrasions on her head like eczema. She has been going to the Dermatologist for the last year. They have been trying to figure out what is going on. Concomitant medications included Phentermine for weight loss. The patient took the shot on a Saturday 23Jan2021. She did fine Sunday, but by Sunday evening on 24Jan2021, she was feeling bad. On 24Jan2021, the patient experienced injection site really red, hard and warm but didn't hurt; head broken out so bad; and joint pain. On 25Jan2021, the patient felt very dizzy/ light headed, fatigue and lethargic. As the evening went on for two to three days later from the vaccination, she experienced side effects. She got up in the middle of the night that night, and her head was broken out so bad that she couldn't comb her hair. There were least 100-150 small little bumps on her head. They almost feel like they have oil under them. They were sore and very irritated. Her scalp was blood red with inflammation. This has went on the course of 8-9 days. She also had joint pain really bad. Almost like a flare up of Hashimoto. She hasn't been having issues with it. It was like her skin was on fire. Even regular water in the shower feels like it was burning. It felt like some kind of nerve ending issue. She was also very off balance, and light headed. She never ran a fever. She was so exhausted that she couldn't get out of bed for the last 8 days. She is scheduled for the second shot. She is scheduled for the second dose 16Feb2021. Her doctor told her to go ahead and get the other shot, but she would like more information. She did not have a prescribing doctor. She got the vaccine at a a local hospital where she goes for testing. She could never get through to get ahold of the hospital so she tried to go through another facility. She finally got an appointment through the hospital. She was wondering if it is okay to get the second shot. She has had a scalp problem, but nobody knows what it is. They have tried to treat it with a steroid. She has seen several who don't have a clue what is could be. Whatever she has, the vaccine aggravated it 10 times worse. The joint pain was almost 100 % better since yesterday. It was mostly in her feet and knees. She was very dizzy and light headed. She wasn't falling all over the place or anything. That has improved over the last day or two. The first night, she got up to go to the bathroom, and she lost her balance but caught self. she was very careful from then on. She has fatigue as well. She still has a little weakness since the 25Jan2021. She never lost her appetite, but she felt very lethargic since the 25Jan2021. She has recovered from most of these issues, except for her head. She is in very good health except for her thyroid issue. That she has been diagnosed with for a couple of years, and the stuff in her hair. They don't know what has caused that. Every test has been negative. She thought at one point it could be the medication she was on. She was taking Phentermine to lose weight. She was wondering if it would have any recourse, but her doctor said no. She quit taking it the day before the shot just in case. She hadn't taken it again until today. The dose is 37.5mg. The way she felt at first, she felt like she had COVID. The patient stated, ""I had some reaction to the (first) Pfizer covid 19 shot I took on 23Jan2021 wanted to ask if I would be able to take the 2nd shot. I took the shot fine, got home. The injection site was red, hard, kind of warm. My arm was never sore but the day after into Sunday I felt very washed out and thought I was tired. I have a thyroid issue, I've been having a scalp problem and this sometimes come with my thyroid issue. Little bumps in my scalp, they were kind of under control because of the Clobetasol propriate foam that I put in my hair and ever since then my skin is on fire. But the main thing I was exhausted, joint pain, knees, feet, even my hands. I laid around and for 5-6 days and today is the first real good day. I still have the bumps but I'm seeing a different dermatologist. I have an over active immune system Hashimoto's disease and something can set up a flare."" The outcome of the events almost like a flare up of hashimoto and a scalp problem, but nobody knows what it is/ whatever she has, the vaccine aggravated it 10 times worse was not recovered; events she was feeling bad, joint pain, knees, feet, even my hands, very dizzy/ light headed, i felt very washed out and thought i was tired/ exhausted, lethargic and she still has a little weakness was recovering; events the injection site was red, hard, kind of warm was recovered in Jan2021; and outcome of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/01/2021,,UNK,PHENTERMINE,Hashimoto's disease; Scalp disorder,"Medical History/Concurrent Conditions: Abrasion (For background, the last couple of months the caller has had abrasions on her head like eczema.); Eczema (For background, the last couple of months the caller has had abrasions on her head like eczema.); Weight loss",,,"['Arthralgia', 'Asthenia', 'Autoimmune thyroiditis', 'Balance disorder', 'Condition aggravated', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Investigation', 'Lethargy', 'Nerve injury', 'Pain in extremity', 'Skin disorder', 'Vaccination site erythema', 'Vaccination site induration', 'Vaccination site warmth']",1,PFIZER\BIONTECH, 1037806,FL,,F,"They are supposed to take the 2nd dose of the vaccine tomorrow. However, they tested positive last Saturday; They are supposed to take the 2nd dose of the vaccine tomorrow. However, they tested positive last Saturday; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported similar events for 2 patients. This is the first of two reports. The female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported ""They are supposed to take the 2nd dose of the vaccine tomorrow. However, they tested positive last Saturday on 23Jan2021. Asking if they should still take the 2nd dose of the vaccine."" The patient underwent lab tests and procedures which included test (sars-cov-2 test): positive on 23Jan2021. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106620 Same reporter, same product. same event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/23/2021,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1037809,NJ,26.0,F,"Spike in blood pressure - BP 178/120; Spike in pulse 120; Dizziness; slight chest pains; Arm tingling, turned into full arm pins/needles/Tingling spread through my left underarm and across left side of chest; This is a spontaneous report from a contactable pharmacist (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302), via an unspecified route of administration into the left arm on 02Feb2021 14:15 at a single dose for covid-19 immunisation. Medical history included allergies to penicillin and mushrooms. Patient was not pregnant. Concomitant medication included desogestrel, ethinylestradiol (APRI) for birth control. The patient previously took azithromycin and experienced drug allergy. On 02Feb2021 14:15, patient experienced spike in blood pressure (BP) 178/120 (unit unspecified), spike in pulse 120 (unit unspecified), dizziness, slight chest pains and arm tingling, turned into full arm pins/needles then tingling spread through her left underarm and across the left side of chest. The patient was treated with potassium tablets in the emergency room. Outcome of events was recovered on an unspecified date.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event blood pressure increased cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,PHM,APRI,,Medical History/Concurrent Conditions: Food allergy; Penicillin allergy,,,"['Blood pressure increased', 'Blood pressure measurement', 'Chest pain', 'Dizziness', 'Heart rate', 'Heart rate increased', 'Paraesthesia']",1,PFIZER\BIONTECH, 1037810,NC,73.0,F,"hypokalemia; heart started pounding hard/diagnosed with heart palpitations and hypokalemia; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9262), via an unspecified route of administration on 01Feb2021 at a single dose for COVID-19 immunization. Medical history included preexisting cardiac issues, she has heart arrhythmia, PAC's and PVC's (all ongoing). The patient's concomitant medications were not reported. On 01Feb2021, later that night (about 12 hours after vaccination), patient's heart started pounding hard. She stated that she has preexisting cardiac issues, she has heart arrhythmia and also has PAC's and PVC's. This is what she used to experience years ago before she was treated with medication. During event on 01Feb2021, EMT that came did EKG at the house, they were concerned about what was seen and patient was taken to Emergency Department and was given some medication to slow her heart rate down. Her EKG was ""very erratic"" and she was given Cardizem which resolved the issue quickly and was also given some Potassium chloride. Troponins and labs drawn on 01Feb2021. The patient was diagnosed with heart palpitations and hypokalemia. She received new cardiac home medications to take and referral to see Cardiologist next week. The patient was wondering if these were side effects from vaccine. Outcome of the events was unknown. The patient was hospitalized for the events.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,Cardiac arrhythmia (preexisting cardiac issues); Premature atrial contraction (preexisting cardiac issues); Premature ventricular contractions,,,,"['Electrocardiogram', 'Hypokalaemia', 'Laboratory test', 'Palpitations', 'Troponin']",1,PFIZER\BIONTECH, 1037811,AR,76.0,F,"Rectal Bleeding; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , solution for injection, lot number: EN5318, expiration date not reported), via an unspecified route of administration on the right arm on 02Feb2021 10:45 at single dose for COVID-19 immunization. Medical history included osteoporosis and allergic reaction to penicillin. The patient is not pregnant. The patient has no prior COVID vaccination. There was no other vaccine given within four weeks. Concomitant medication included atorvastatin, calcium, magnesium. The patient experienced rectal bleeding on 03Feb2021 09:00. Patient reported that she had her first shot yesterday morning and today when she went to the bathroom she has rectal bleeding, bright red blood, which is not normal for her. The patient was not tested for COVID post vaccination. Outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/03/2021,1.0,UNK,ATORVASTATIN; CALCIUM; MAGNESIUM,,Medical History/Concurrent Conditions: Osteoporosis; Penicillin allergy,,,['Rectal haemorrhage'],1,PFIZER\BIONTECH, 1037812,NY,52.0,F,"I had an abscess tooth that became infected; UTI; headache; stomach bloating; pressure and discomfort; blood in my urine; This is a spontaneous report from a contactable consumer (patient herself). A 52-year-old female received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 18Jan2021 at 10:30 AM as a single dose for COVID-19 immunization. The patient had no relevant medical history. The patient ha d no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination, has not been tested for COVID-19 since the vaccination, and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine and also did not receive any other medication within two weeks of vaccination. The patient had a headache on 22Jan2021 for 5 days. She also had stomach bloating and pressure and discomfort on 22Jan2021. It was reported that when she saw blood in her urine, she went to a walk-in and was diagnosed with a UTI on 22Jan2021. She did 7 days of an antibiotic. Then on 30Jan2021, she had an abscess tooth that became infected. It was reported that the patient received antibiotics for both infections. It was reported that the events result in a doctor or other healthcare professional office/clinic visit and an Emergency room/department or urgent care. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/22/2021,4.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Abdominal distension', 'Blood urine present', 'Discomfort', 'Headache', 'Tooth abscess', 'Urinary tract infection']",1,PFIZER\BIONTECH, 1037813,WI,77.0,M,"Hypothermia/A temperature of 93.7 orally/temperature was 92.7/went down to 93.2 degrees; Chills; The arm he received the injection in was tender however progressed to mild to moderately painful/arm was suddenly painful; Shaking; Injection site tenderness; This is a spontaneous report from a contactable physician (patient). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9262, expiry: unknown), via an unspecified route of administration in the left arm on 26Jan2021 15:30 at a single dose for protection from the virus at the Physician Office. Medical history included type 2 diabetes mellitus from 2011 and ongoing. The patient also thought he had a Covid respiratory infection in Feb2020. He had a prolonged moderate to severe respiratory infection. He thought at first that he had the flu, but he had a flu shot. He thinks he had Covid. He had antibody studies in May2020 (last spring) that were negative. The patient has no concomitant medications. The patient previously had influenza vaccine (flu shot). The patient reported hypothermia after getting the first dose of the Pfizer Covid 19 vaccine. On the same day of vaccination (26Jan2021), he had injection site tenderness. The next day, (27Jan2021), his arm was suddenly painful; he began to have chills 29 hours after receiving the vaccine (27Jan2021) and was shaking. He also had a temperature of 93.7 orally, confirmed with two different digital thermometers. He took his temperature with a new electronic thermometer that he purchased at a pharmacy. His temperature was 92.7 on 27Jan2021. He repeated it with another electronic thermometer. The first evening (27Jan2021), his temperature went to 96.5 to 98 degrees. Then it went down to 93.2 degrees. He covered up with blankets and his temperature increased and the chills stopped. He stated that this was hypothermia. He had low temperatures the following day (28Jan2021) as well, his temperature was 93-94 degrees. His temperature was 93.7 degrees. Other times he checked his temperature and it was 96.5 degrees. When his temperature was low the first time, it only lasted for about three hours. The second time it happened he went to bed and covered up. It lasted for an hour or two. He noticed it again two days ago. The patient also stated the arm he received the injection in was tender however progressed to mild to moderately painful when he experienced the chills and low temperatures. The arm tenderness after getting the vaccine was very mild. He noticed it when he rolled over on his arm. He took some Tylenol for it. His son is an internist. He said the hypothermia was medically significant. His son also said hypothermia is equivalent to a fever in the elderly. The patient wanted to know if there have been any reports of hypothermia after the administration of the vaccine. He has concerns about this occurring after the second dose. He is scheduled to receive the second dose on 15Feb2021 or 16Feb2021. The outcome of the event hypothermia was recovered on 30Jan2021 and pain in arm recovered on 27Jan2021. The outcome of the other events was unknown. The events hypothermia, arm pain and injections site tenderness were assessed as related to BNT16B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported hypothermia and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PVT,,Type 2 diabetes mellitus,Medical History/Concurrent Conditions: Respiratory infection; Suspected COVID-19,,,"['Body temperature', 'Chills', 'Hypothermia', 'Pain in extremity', 'SARS-CoV-2 antibody test', 'Tremor', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1037814,MA,,M,"Just tested positive for covid.; Just tested positive for covid.; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient's wife) reported for a male patient (husband). A male patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received their first dose. Just tested positive for covid on an unspecified date. The outcome of the events was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1037815,,,F,"She almost instantly completely lost hearing in her right ear / loss of hearing; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 28Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported she had the first shot of the vaccine on 28Jan2021, then on 30Jan2021 she reported that she almost instantly completely lost hearing in her right ear. She said it hasn't changed since. She already had a CT scan and MRI scan with her doctor, and she wanted to eliminate the vaccine shot as the cause of her loss of hearing. Outcome of the event was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/30/2021,2.0,UNK,,,,,,"['Computerised tomogram', 'Deafness', 'Magnetic resonance imaging']",1,PFIZER\BIONTECH, 1037816,,,M,"broken hip; fell out of bed; positive test for COVID19; This is a spontaneous report from a contactable consumer (patient's child). An 80-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history included parkinson's disease. Concomitant medications were not reported. The patient was scheduled to receive the second dose on 12Feb2021. Yesterday (01Feb2021), the patient fell out of bed with a broken hip. The patient was hospitalized and was scheduled for surgery today (02Feb2021) with a positive test for COVID-19. Outcome of the events was unknown. The reporter was asking if the vaccine would register a false positive on a rapid test and if her father is positive for COVID in between both doses of the vaccine, is it recommended that he not get the shot. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/22/2021,02/01/2021,10.0,UNK,,,Medical History/Concurrent Conditions: Parkinson's disease,,,"['Fall', 'Hip fracture', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1037817,LA,74.0,M,"Unable to comprehend description of movie displayed on monitor/did not make convey idea, but each word was understood; word finding difficulty; Medical history included Crohn's and prostate cancer (CA)/vedolizumab (ENTYVIO); Medical history included Crohn's and prostate cancer (CA)/vedolizumab (ENTYVIO); This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1283), via an unspecified route of administration, left arm, first dose on 09Jan2021 16:00 at a single dose and for COVID-19 immunization. Medical history included Crohn's and prostate cancer (CA). The patient has no known allergies. Concomitant medication included celecoxib, vedolizumab (ENTYVIO), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and vitamin b complex. The patient also takes ""garlic multi"". The patient had no other vaccine in four weeks. The patient has no COVID prior to vaccination. Covid test via nasal swab on 11Jan2021 with result of negative. On 11Jan2021 at 19:30, the patient was unable to comprehend description of movie displayed on monitor. Words did not make convey idea, but each word was understood. The patient went to hospital for transient ischaemic attack (TIA), no findings overnight then at home word finding difficult about 12 hours later (Jan2021). The patient was brought back to the hospital, no evidence of TIA or cerebrovascular accident (CVA). The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for four days. The patient recovered with lasting effects. The patient had MRI, CT and ECHO with unknown results in Jan2021. The patient received statins, topiramate magnesium infusion as treatment. The patient received the second dose (lot number: El9265) via an unspecified route of administration, right arm on 30Jan2021 for COVID-19 immunization.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/09/2021,01/01/2021,,PVT,CELECOXIB; ENTYVIO; VITAMIN C [ASCORBIC ACID]; VIT B COMPLEX,,Medical History/Concurrent Conditions: Crohn's disease; Prostate cancer,,,"['Aphasia', 'Computerised tomogram', 'Echocardiogram', 'Magnetic resonance imaging', 'Mental impairment', 'Off label use', 'Product use issue', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1037818,NY,57.0,F,"R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; decreased hearing to my R ear; The pain was worse in my R jaw- both upper and lower teeth pain; The pain was worse in my R jaw- both upper and lower teeth pain; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; decreased taste on the R side of my tongue; fatigue; muscle aches; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL 3248, Expiration date: Apr2021), via an unspecified route of administration at the left arm on 14Jan2021 08:15 at a single dose for covid-19 immunization. The vaccine was administered in a hospital. Medical history includes shrimp allergy. The patient was not pregnant at the time of vaccination. Concomitant medication was not reported. Historical vaccine includes 1st dose of bnt162b2 for COVID-19 immunization on 24Dec2020 09:30 AM, at the left arm, Lot number: EK9231 and Expiration date: Apr2021 at age of 57 years. The patient developed extreme fatigue, some muscle aches on 18Jan2021. She woke up with painful (pins and needle sensation) swollen hands. Took some TYLENOL and elevated them for a few hrs. The swelling subsided by the afternoon. On 19Jan2021, she developed R sided neck and facial swelling with nerve pain. The pain was worse in her R jaw- both upper and lower teeth pain, nerve pain extending from the side of my R ear up to my R eye and temple area. Feeling of heaviness to her R eye, R cheek, R side of her tongue, decreased hearing to her R ear (sounds muffled like being under water), decreased taste on the R side of heer tongue. Took benedryl and tylenol all day. On 20Jan2021, after a restless night due to the nerve pain (not relieved by tylenol) went to work but the swelling worsened so she was sent to the ED. They treated me with IV decadron, IV benedry, IV zofran- which immediately took away the swelling. The events result to Emergency Room/ Urgent Care Visit. Prior to vaccination the patient was not diagnosed with COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021, the patient had Nasal Swab, PCR, covid test result was negative. The events were assessed as non-serious by the reporter, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/18/2021,4.0,PVT,,,Medical History/Concurrent Conditions: Shellfish allergy,,,"['Asthenopia', 'Facial discomfort', 'Fatigue', 'Hypoacusis', 'Hypogeusia', 'Myalgia', 'Neuralgia', 'Pain in extremity', 'Pain in jaw', 'Paraesthesia', 'Peripheral swelling', 'SARS-CoV-2 test', 'Swelling', 'Swelling face', 'Tongue disorder', 'Toothache']",2,PFIZER\BIONTECH, 1037819,FL,,F,"Caller had Covid vaccine on 28Jan and tested positive for Covid today; Caller had Covid vaccine on 28Jan and tested positive for Covid today; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 28Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had Covid vaccine on 28Jan2021 and tested positive for Covid today 30Jan2021. She is wondering what to do about 2nd dose and wonders if this is normal. The patient underwent lab tests and procedures which included COVID: positive on 30Jan2021. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/30/2021,2.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1037820,KY,88.0,M,"positive COVID-19 test; positive COVID-19 test; This is a spontaneous report received from a contactable nurse. An 88-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) Intramuscularly on 13Jan2021 at single dose for COVID-19 immunization in a nursing home/senior living facility. Medical history included s/p cerebrovascular accident (CVA), Insulin dependent diabetes mellitus (IDDM) and hypertension (HTN). The patient had no allergies with medications, food or other products. Concomitant medication included insulin glargine (LANTUS). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The resident (patient) tested positive in the SARS-Cov2-RT PCR (nasal swab) on 01Feb2021. Patient did not receive treatment for the adverse event. Event was considered by the reporter as non-serious. Outcome of events was recovering. Information on the lot number and batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,02/01/2021,19.0,SEN,LANTUS,,Medical History/Concurrent Conditions: CVA (s/p CVA); Hypertension; IDDM,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1037822,WI,48.0,F,"pass out; vomiting; Severe muscle pains; Severe headache; This is a spontaneous report from a contactable Other HCP (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 at 10:00 at single dose in left arm for COVID-19 immunisation at the age of 48-year-old. Lot number was EL3248. Medical history included asthma, migraine headaches, thyroiditis. Concomitant medications included levothyroxine, fluoxetine, bupripion, clonazepam. The patient was not pregnant. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Jan2021 at 15:00 at single dose in right arm for COVID-19 immunisation at the age of 48-year-old. On 02Feb2021 at 23:00, the patient experienced severe vomiting which kept the patient up most of the night, she had to stay by toilet; the patient was feeling like she was going to pass out with any movement, the patient experienced severe muscle pains that felt almost like bones were breaking inside; the patient experienced severe headache; the patient almost took her-self to the emergency room in the middle of the night, but she did not want to expose her compromised immune system to others. The patient was not treated for the events. The patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the LOC and other reported events due to temporal relationship Additional information is needed to better assess the case, including complete medical history, diagnostics including chemistry panel, Head CT/MRI and EKG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/02/2021,1.0,PVT,LEVOTHYROXINE; FLUOXETINE; BUPROPION; CLONAZEPAM,,Medical History/Concurrent Conditions: Asthma; Migraine headache; Thyroiditis,,,"['Headache', 'Loss of consciousness', 'Myalgia', 'Vomiting']",2,PFIZER\BIONTECH, 1037824,IN,64.0,F,"Swollen and blistered lips; Swollen and blistered lips; Itching inside my mouth and throat, and on my hands and legs; Itching inside my mouth and throat, and on my hands and legs; Itching inside my mouth and throat, and on my hands and legs; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiration date was not reported) given at 64 years of age, via an unspecified route of administration in the left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunisation. Medical history included known allergies. Concomitant medication included thyroid (ARMOUR THYROID), aluminium hydroxide gel, dried, magnesium carbonate (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]), and metronidazole. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was she tested for COVID-19 since the vaccination. It was reported that less than one hour after receiving the vaccine on 25Jan2021 at 04:00 PM, the patient developed itching inside her mouth and throat, and on her hands and legs. The itching stopped with BENADRYL. Four days later on 29Jan2021 14:30, she developed swollen and blistered lips. The outcome of the events was recovering and were reported non-serious. Treatment received for the events included steroid injection five days after the vaccine. The events resulted to doctor or other healthcare professional office/clinic visit then emergency room/department or urgent care.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,PVT,"ARMOUR THYROID; PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]; METRONIDAZOLE",,Medical History/Concurrent Conditions: Allergy,,,"['Lip blister', 'Lip swelling', 'Oral pruritus', 'Pruritus', 'Throat irritation']",1,PFIZER\BIONTECH, 1037825,FL,74.0,F,"Nausea; Dizziness and room spinning; room was spinning; her white blood cell count was elevated; Kidney failure and allergic reaction; Allergic Reaction; still wasn't feeling normal; Could not keep head up and was in bed; breathless; extreme fatigue; exhausted and weak; Heart was banging fiercely; Totally dehydrated; Urinating a great deal more; Chills, shakes and felt terrible; Chills, shakes and felt terrible; sicker every single day/sick/felt terrible; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on the left arm on 18Jan2021 14:30 at a single dose for prevention for COVID. Medical history included hip replacement on 04Jan2021 and fibromyalgia (When her children were younger, she was told she had Fibromyalgia). Family history includes diabetes (father late onset) and very rare cancer (mother). There were no concomitant medications. It was reported that the patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and got sick the next day (19Jan2021). She also mentioned that she got sicker every single day. Then after 8-9 days, she said she started to feel better, but still wasn't feeling normal. She said she had extreme fatigue, was breathless, and felt exhausted and weak on an unspecified date. She said she was supposed to receive the 2nd dose of the vaccine this Monday (unspecified date), but because of her side effects, she was told that she can come back to receive the 2nd dose after 6 weeks. She wants to know if this is acceptable. The patient reported that on 19Jan2021, she woke up in the middle of the night with chills, shakes, and felt terrible. She cancelled her plans for Tuesday (as reported). On Wednesday, she forced herself to get up and went out for lunch and came home. She could not keep her head up and went back to bed and that lasted several days. It got worse before it got better. She ended up being hospitalized for 4 days (25Jan2021 to 29Jan2021). It appeared to be she was in Kidney Failure and experienced allergic reaction on 25Jan2021 and her white blood cell count was elevated (unspecified date). She went to the ER and they kept her 6-8 hours and discharged her on a Friday and by Monday, she was admitted to the hospital. The first ER visit, she was there for 6-8 hours and they sent her home. They gave her IV fluids and took a lot of tests. The patient's first ER visit was on 22Jan2021, and was kept for 6-8 hours and released. She was given IV fluids and they did a lot of tests. She went to see her doctor and sent her to the emergency room. They took her blood, EKG and everything seemed ok. Creat was 1.0 and by Monday it was 1.6 and then on Friday it was 1.9 (unspecified dates). She was admitted to hospital on Monday and they gave her IV fluids and did kidney test and admitted her as soon as she could get a room. She never had a problem before with her kidneys. They did bacteria test and they were normal. The patient called her doctor on 24Jan2021, because she was nauseous, dizzy, and room was spinning and she felt worse. She went to his office on Monday morning and he put her right in the hospital (unspecified date). She got worse and now it is improved. Heart was banging fiercely on 22Jan2021 20:00. They took an Echocardiogram. She has never had a cardiac problem and could not find anything wrong with her heart. The patient started feeling a bit better. She was sick as can be through Sunday. By Tuesday (unspecified date), she was a little better and today is a little better. She is urinating a great deal more because of fluids, but later said it started the day after she got it. She had to get an aide to take care of her. The patient experienced totally dehydrated on 22Jan2021 14:00 and urinating a great deal more on 19Jan2021 03:00. Therapeutic measures were taken as a result of kidney failure, allergic reaction and white blood cell count was elevated. The outcome of the events sicker every single day/sick, chills, shakes and felt terrible was not recovered; event could not keep head up and was in bed recovered with sequel; events nausea, dizziness and room spinning, heart was banging fiercely, totally dehydrated, urinating a great deal more was recovering; while unknown for the rest of the events.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/18/2021,01/19/2021,1.0,UNK,,,"Medical History/Concurrent Conditions: Cancer (Mother); Diabetes (Father (late onset)); Fibromyalgia (When her children were younger, she was told she had Fibromyalgia); Hip replacement",,,"['Asthenia', 'Bacterial test', 'Blood creatine', 'Blood test', 'Chills', 'Dehydration', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Fatigue', 'Feeling abnormal', 'Head discomfort', 'Heart rate', 'Heart rate abnormal', 'Hypersensitivity', 'Malaise', 'Nausea', 'Renal failure', 'Tremor', 'Urine output increased', 'Vertigo', 'White blood cell count', 'White blood cell count increased']",1,PFIZER\BIONTECH, 1037826,NY,51.0,F,"Bell's Palsy; This is a spontaneous report from a contactable other health care professional (patient). A 51-year-old female patient (Pregnant: No) received second dose of bnt162b2 (Lot number: EL9264), via an unspecified route of administration in left arm on 29Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included ammonium succinate, calcium succinate, glutamate sodium, glycine, magnesium succinate, tocopheryl acetate, zinc difumarate hydrate (AMBEREN), collagen, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTICS) and multi-vitamin. The patient previous received first dose of bnt162b2 (Lot number: EL0143), via an unspecified route of administration in left arm on 07Jan2021 14:00 for COVID-19 immunization. The patient experienced bell's palsy (hospitalization) on 30Jan2021 09:00. The patient was hospitalized for bell's palsy for 2 days. The patient was admitted on 30Jan2021 to hospital and diagnosed with Bell's Palsy. Treatment included: Prednisone and Valacyclovir. Facility type vaccine was hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. The outcome of event was not resolved.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/29/2021,01/30/2021,1.0,PVT,AMBEREN; COLLAGEN; PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS],,Medical History/Concurrent Conditions: Asthma,,,['Facial paralysis'],2,PFIZER\BIONTECH, 1037827,,62.0,M,"Bleeding down his arm afterward; He received a dose in his left arm, and noticed he was bleeding down his arm afterward/He had another dose given in his right arm; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), first in the left arm and second dose in the right arm, both via an unspecified route of administration on 02Feb2021 at single doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received his first round of Pfizer-Biontech Covid19 vaccine yesterday 02Feb2021. He received a dose in his left arm, and noticed he was bleeding down his arm afterward, which was out of character for him. When he alerted his nurse who had administered the vaccine, she discussed it with a colleague who said ""go ahead and give him another one"". He had another dose (second dose) given in his right arm on 02Feb2021. Patient stated he's ""feeling fine"". He wanted to know if he still needs to get the second dose in the series. It was also further reported as they gave him the shot in the left arm and he started to bleed. He got a 2nd one in the right arm. He was feeling fine. The nurse asked another nurs- and she said, ""go ahead and give him another one"". The outcome of the event bleeding down his arm afterward was unknown. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/02/2021,0.0,UNK,,,,,,"['Haemorrhage', 'Overdose']",1,PFIZER\BIONTECH, 1037828,PA,41.0,F,"After the first vaccine, she started getting them a little/after the first vaccine, caller started to have hot flashes again; She had a hormone reaction to it; affecting her mental health; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via an unspecified route of administration on 29Dec2021 at single dose for covid-19 immunization. Medical history included ongoing artificial menopause (Surgical menopause, since she was 36). The patient's concomitant medications were not reported. After the first vaccine, caller started to have hot flashes again, and after the second vaccine they became unbearable. She had a reaction to the vaccine. She had a hormone reaction to it. The caller did research herself to look up hormonal things about the Pfizer vaccine, but she could not find anything. The only information she found was on pregnancy and breast feeding, and low estrogen with COVID. They had significantly subsided over the last year and half to two years. After the first vaccine, she started getting them a little. Then, after second vaccine her hot flashes started being unbearable. She was unsure if it had to do with the vaccine, but she felt like it did. She spoke with nurses she works with. They too had hormonal issues after the vaccine. One had difficulty getting her period for 9 months to a year, but then got their period. She talked to people in menopause who have not had their period for a year, and had one after the vaccine. She talked to women with PCOS that had difficulty getting their period, but got their period after the vaccine. She also talked to women who had normal menopause, that hadn't had their period in a long time get a period. She said this was all generalized information. She doesn't have the specifics for the people that reported it. There was something hormonal going on. It was literally driving her nuts. Her first vaccine she got on the 29Dec2020, Lot number: EJ1686. Her second vaccine she got on 19Jan2021, lot number: EL9261. This all started a week after the first shot, and got worse after the second. She felt like this was medically significant. There was a fine line between medical issues and mental health, and she felt like this was affecting her mental health. Outcome of events was not recovered. Reaction assessed: after the first vaccine, caller started to have hot flashes again, and after the second vaccine they became unbearable. Source of assessment: Primary Source Reporter; Method of assessment: Global Introspection; Drug result: Related.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,,,UNK,,Surgical menopause (Surgical menopause),,,,"['Hormone level abnormal', 'Hot flush', 'Mental disorder']",1,PFIZER\BIONTECH, 1037830,DE,90.0,F,"Bleeding; seeping from lower leg; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration in the right arm, on 03Feb2021 10:30, at a single dose, for COVID-19 immunization. Medical history included breast cancer and chronic obstructive pulmonary disease (COPD). The patient has no known allergies. The patient has many unspecified concomitant medications. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in other facility. On 03Feb2021, at 11:00 A.M., the patient experienced bleeding/seeping from lower leg. The patient did not receive treatment for the events. Outcome of the events not recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Breast cancer female; COPD,,,"['Haemorrhage', 'Limb injury']",UNK,PFIZER\BIONTECH, 1037833,,,F,"stage 1 lung cancer; This is a spontaneous report from Pfizer sponsored program. A contactable consumer (patient herself) reported that a 59-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 12Feb2021 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She informed that 3 days after the shot, she had CT with contrast for stage 1 lung cancer. She was scheduled to receive the Pfizer-BioNTech COVID-19 Vaccine Dose 2 on 12Feb2021. The outcome of event was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Computerised tomogram', 'Lung carcinoma cell type unspecified stage I']",1,PFIZER\BIONTECH, 1037834,NC,51.0,F,"Bell's Palsy/right side of my face is completely paralyzed; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1283), via an unspecified route of administration on 21Jan2021 17:45 at single dose (left arm) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products and patient was not pregnant. On 23Jan2021, the patient experienced Bell's Palsy about 48 hours after receiving the vaccine. The right side of her face was completely paralyzed. The patient was treated with prednisone and valacyclovir. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/23/2021,2.0,PVT,,,,,,['Facial paralysis'],1,PFIZER\BIONTECH, 1037835,,,M,I practically passed out and couldn't stand up; I practically passed out and couldn't stand up; This is a spontaneous report from a contactable consumer (Patient). A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 at 10:45 at single dose for COVID-19 immunization. The patient medical history included ex-alcohol user (didn't drink anymore). Concomitant medications were not reported. The patient reported he practically passed out and couldn't stand up on 03Feb2021 at 15:15. Patient was pretty healthy and didn't drink anymore. Things like that used to happen when he drank but not now. He hoped it wasn't something neurologic going on with my body. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,02/03/2021,6.0,UNK,,,Medical History/Concurrent Conditions: Ex-alcohol user,,,"['Dysstasia', 'Loss of consciousness']",1,PFIZER\BIONTECH, 1037836,NJ,19.0,F,"Patient fainted; This is a spontaneous report from a contactable pharmacist. A 19-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982), intramuscular in the left arm on 04Feb2021 12:00 at single dose for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient medical history and concomitant medications were not reported. The patient fainted on 04Feb2021 12:00 with outcome of recovered in Feb2021. No treatment was performed due to the event. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between event syncope and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,UNK,,,,,,['Syncope'],1,PFIZER\BIONTECH,OT 1037837,CA,,F,"ultrasound revealed blood clots at right leg; Swollen ankle and foot after 5-6 days of first dose; Swollen ankle and foot after 5-6 days of first dose; This is a spontaneous report from a contactable consumer reported for herself. A 73-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 20Jan2021 11:00 at single dose for COVID-19 immunisation. The patient was vaccinated in nursing home/senior living facility. Medical history included high blood pressure, monitored for lymph node growth. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included high blood pressure medication and clonazepam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen ankle and foot on 25Jan2021 12:00 AM after 5-6 days of first dose, ultrasound revealed blood clots at right leg. Doctor ordered to take apixaban (ELIQUIS) immediately during second week. The events resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/25/2021,5.0,SEN,CLONAZEPAM,,Medical History/Concurrent Conditions: Blood pressure high; Lymph node disorder (monitored for lymph node growth.),,,"['Joint swelling', 'Peripheral swelling', 'Thrombosis', 'Ultrasound scan']",1,PFIZER\BIONTECH, 1037838,CA,42.0,F,"tested positive for COVID after the 1st dose of Pfizer.; This is a spontaneous report from a consumer or other non hcp. A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration left arm on 20Jan2021 09:45 at 0.3 mL, single dose, for COVID-19 immunisation. Medical history included obesity, hypertension. Concomitant drugs were not reported. No other vaccine was received in four weeks. The patient experienced tested positive for covid nasal swab test on 28Jan2021. The patient was hospitalized for 4 days. Patient was treated with oxygen. The outcome was recovering.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/20/2021,01/28/2021,8.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure high; Obesity,,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1037839,NJ,57.0,M,"cough; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 57-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Jan2021 (at the age of 57-years old) as a SINGLE DOSE for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient was scheduled to get the second shot on 05Feb2021. Patient got COVID like symptoms, he had a cough and ""all that stuff"" starting about 3 days ago on unspecified date in 2021. He went to a pharmacy to get tested and waiting for results. He went to the hospital right after (pharmacy) and got admitted on 03Feb2021 and was still in hospital right now. His doctor suggested not to get the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on 03Feb2021. Outcome of the cough was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/18/2021,,,UNK,,,,,,"['Cough', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1037840,,75.0,F,"Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; headache; high bp/ had a BP 173/113; short of breath; couldn't sleep; restless; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Ten minutes after she reported having a headache, which she ignored. 2 hours later, very high blood pressure (BP), short of breath (SOB) and restless occurred. All night on 25Jan2021 and the next day on 26Jan2021, the patient couldn't sleep, short of breath, restless. The patient called PCP and was told to go to the ER. She did and had a BP 173/113, SOB. She was admitted, CT scan was ok. She had very bad rash blue red swollen on thigh. Heart enzymes was normal. She was discharged two days later referral to a dermatologist. The outcome of events was unknown. Information on the batch number has been requested.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/25/2021,01/25/2021,0.0,UNK,,,,,,"['Blood pressure measurement', 'Computerised tomogram', 'Dyspnoea', 'Erythema', 'Headache', 'Hypertension', 'Insomnia', 'Myocardial necrosis marker', 'Peripheral swelling', 'Rash', 'Restlessness', 'Skin discolouration']",1,PFIZER\BIONTECH, 1037841,OH,81.0,F,"my head and ears closed down; my head and ears closed down; she doesn't sleep all night long; her body was shaking; my heart was beating out of my chest; felt a little lazy and tired; tinge-y pains in her heart; SVT; shortness of breath; This is a spontaneous report from a contactable consumer (patient). An 81-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261, Expiry date: 31May2021), via an unspecified route of administration on 19Jan2021 at Single Dose (dose unknown; by injection once to left upper arm) for covid-19 immunisation, levothyroxine sodium (SYNTHROID), orally from an unspecified date to an unspecified date at 0.75 mg once a day, and orally from an unspecified date to an unspecified date at 0.88 mg, once a day for thyroid disorder. Medical history included cancer, heart stents, irregular high blood pressure, breathing problem, underactive thyroid, back problem. The patient's concomitant medications were not reported. The patient took a flu shot 20 years ago for immunization and got really sick, took Pneumonia shots for immunization and was fine. On 19Jan2021, the patient had a little lazy and tired. On 21Jan2021, her heart was beating out of her chest, like she had a drum going off; beating so fast and rapid it, and her head felt closed off and ears- she could feel heartbeats in her head; on 21Jan2021, her body was shaking. In Jan2021, she had a couple tinge-y pains in her heart and shortness of breath; she had SVG, she thought, it was irregular heartbeats coming from the top of her heart. Details were as follows: On 22Jan2021, she woke up in the morning around 3-4 am and said ""my heart was beating out of my chest and my head and ears closed down."" The sensation subsided by 8 am. She called her family MD who did not respond so the following Monday she was in contact with her cardiologist who put her on a Holter monitor for a few days. He later told her she had SVT and prescribed a beta blocker for her to take. The patient stated ""I am so allergic to medicine."" She took Plavix after a stent 5 years ago and was fine taking it for a few years. Then she had another stent placed, was prescribed Plavix again, and was ""so sick and dizzy and short of breath - it was the Plavix."" States that she can take Cipro, ibuprofen, and synthroid and that her list of allergies is about ""2 pages long."" The patient wanted to know if she should take the second dose? her cardiologist advised that she not take it. Caller states she doesn't want to take the second dose and probably won't. She had a long history of allergic reactions to medications. She never had the flu, she hasn't had mumps, chicken pox, measles, occasionally, rarely a cold, about 20 years ago, she took a flu vaccine and got so sick after the shot and never took it again, she never got the flu, she does take Pneumonia shots and was fine. States she seems to have a natural immunity against typical disease you can catch. Other things, she had cancer, heart stents, and things of that sort, as far as infectious diseases, she had no problems. She had a reaction she thinks came from the COVID shot. She had a blood test and it showed her thyroid went a bit more underactive, so about 2 weeks ago, her Synthroid was raised from 0.75mg to 0.88mg, so 0.88mg was a new medication, but it was minimal. Communication: Caller was advised to slow down to assure accurate documentation. Synthroid 0.75mg: no NDC, lot, expiry. States this has been her only change in meds recently. She got that Synthroid the same day as she got her COVID vaccination, which was 19Jan2021, that afternoon, she got a Pfizer COVID vaccination. Also she got a prescription for her new Synthroid. The first day, 19Jan2012, she had no reaction at all, she took two Tylenol, someone suggested. She felt a little lazy and tired, for the rest of Tuesday, then Wednesday she felt more tired, she laid around on the couch watching TV, she stayed in her pajamas, had no serious reaction, just tired, then Tuesday and Wednesday, and then on Thursday night, she never did anything on Thursday either, she went to grocery store, was not feeling better, and on Thursday, 21Jan2021, at 3AM, she was awakened from sleeping, she did not sleep all night long, she got up often, her heart, she never had this before and had 3 stents, her heart was beating out of her chest, like she had a drum going off, it was beating so fast and rapid and her head felt closed off and ears- she could feel heartbeats in her head, and this went on, she didn't want to call, she lives by herself on a farm, and thought to wait and see if it goes away, and about 7AM, it was basically really bad from 3AM to 5AM, and at 7AM it went away, the rapid heartbeat was so far throughout and her body was shaking, and chest was so she never had it happen before. At 8AM she called her family doctor office, she wanted to go and see them and she was told she wasn't in that day, they would send a note in the computer to get back with her. The doctor did not get back with her all day Friday, and then she felt ok Friday, Saturday, and Sunday, she had a couple tinge-y pains in her heart and shortness of breath, but her heart didn't feel like it was beating out of rhythm. Then Monday morning she called her heart doctor, he said he doesn't know, it doesn't sound to him like it was the Synthroid, since it was a small change of dose, but he didn't know about COVID but he hadn't heard it as being an after effect, but he said to come by 2:30PM on Monday, to be fitted with a heart monitor, which she wears on her heart and it listens 24/7, listens to her heart function, so she wore that, he said to bring it back on Monday and leave it in the office, and she did that, she wore it Friday, Saturday, Sunday, and Monday, she never had that really huge feeling in her in heart anymore, she thought it was a waste of time, then she got a call from the heart doctor on Tuesday, he asked how she was feeling, she said she was fine, and sorry if she caused a commotion and he said she has a heart problem now, she said she didn't feel anything, but her heart is beating erratically, and he doesn't know why she didn't feel it, he said she has SVG, she thinks, it is irregular heartbeats coming from the top of her heart and he says he will send in a prescription to the pharmacy to get a beta blocker, she thinks Metoprolol. The pharmacy just got the medicine in and she is sitting there waiting now. He told her a couple months ago, her heart sounds fine, there seemed to be nothing the matter. She asked if it was the COVID vaccine, he said he doesn't know, and she asked if she should take the second dose on 09Feb2021, he said no, he doesn't think he wants her to take it, she is going to see him in 2 weeks and will try the medicine, but she wanted to report what happened to her. Has Pfizer heard of anyone having rapid heartbeat after COVID vaccination. States she is overweight. Second dose is scheduled for 09Feb2021, at 1PM. Caller states going from 0.75mg to 0.88mg on Synthroid is a minimal adjustment, it can go up to the 200's for underactive thyroid, it's minimum, she is supposed to take it on an empty stomach, first thing in the morning with water. She has had underactive thyroid since she was 20 years old, so for 40 years, and had no problems with Synthroid before. The patient had irregular high blood pressure: it is high during the night and normal during the day, and if she would take, she had been going to physical therapy, she had a back problem, it came from a different thing, her knee is bone on bone, and they want her to get a knee implant, but when she limps on her knee it makes her back, it hurts from not walking straight, so she went to physical therapy, and what was causing high blood pressure, if she took Ibuprofen or Aleve, it would significantly increase her blood pressure, so she has a sensitivity to pain medicine, especially Ibuprofen and Advil, it increases her blood pressure, and often when she doesn't have it in her system, her blood pressure is much more normal. She does not have Ibuprofen, Aleve, Advil to provide lot/expiry, she is in her car. She is interested, she feels she won't take the second vaccine, she wants to see what they say, she also wants to ask how much protection with just the first shot? The action taken in response to the event for levothyroxine sodium was unknown. The outcome of the events heart was 'beating out of chest', 'head and ears closed down' was recovered in Jan2021, of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/01/2021,,UNK,SYNTHROID,,Medical History/Concurrent Conditions: Back disorder; Blood pressure high (irregular high blood pressure); Breathing difficult (breathing problem); Cancer; Stent replacement; Thyroid function decreased (since she was 20 years old),,,"['Angina pectoris', 'Blood test', 'Dyspnoea', 'Ear disorder', 'Fatigue', 'Head discomfort', 'Heart rate', 'Insomnia', 'Palpitations', 'Supraventricular tachycardia', 'Tremor']",UNK,PFIZER\BIONTECH, 1037842,FL,79.0,F,"may have had a mini stroke; Bell's Palsy/developed facial drooping/her eye was drooping; fell; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (BNT162B2, Pfizer COVID-19 Vaccine; Batch/lot number: EL9262), via an unspecified route of administration injection to right upper arm on 22Jan2021 14:00 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing she was a fainter (She was a fainter, she just faints so she has a hard time getting shots. Pfizer COVID-19 Vaccine administered to her by nurse while she was in her car seat. She just asked the nurse to let her lay down in the car seat when injection was administered so that if she fainted she would not fall far; she was still getting the wash cloth on her head preparing when the Nurse had already finished administering the injection.); ongoing depressed sometimes (she was depressed sometimes, was stressed. She was the primary caregiver for her 96 year old mother. She had seen something about stress and COVID and shots and everything); ongoing Very tired (She was almost 80 years old so she was very tired often. She was the primary caregiver for her 96 year old mother. By the time she comes home at night around 21:30 she was just wiped.); Obesity (She was really overweight but she did not like the term obesity.); thyroid disorder; hypertension; Cataract and glaucoma in left eye; family history of ongoing facial paralysis (Dad had Bell's palsy that might have been 30 years ago. He died at age 87 years.); diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes). Concomitant medication included Levothyroxine at 100mcg taken once daily in the morning early before she eats with Start date unknown, but at least 10-15 years ago for Thyroid. Enalapril at 10mg taken once daily (Caller initially reported product name as Vasotec, but clarified it is not Vasotec, it is drop for eye cataract and glaucoma) for High blood pressure. Brimonidine with Strength unknown, 1 drop in both eyes twice daily, started maybe 1 year ago. Specified cataract and glaucoma in left eye; but drop was administered to both eyes; and left eye was eye affected by Bell's palsy for Cataract and glaucoma in left eye. The patient previously took codeine and experienced allergy with onset maybe about 50 years ago, she was not sure; occurred during dental procedure; had bad headaches but no lasting effects so they assumed allergy to codeine; she did not know if still has allergy but says she does if asked. The patient experienced bell's palsy/developed facial drooping/her eye was drooping on 29Jan2021 with outcome of recovering, may have had a mini stroke on an unspecified date with outcome of unknown , fell on 27Jan2021 with outcome of unknown (reported date of end of reaction was 27Jan2021), she could not blink that eye on 29Jan2021 with outcome of not recovered. Five days later she fell and developed facial drooping. HCP suggested she may have had a mini stroke causing facial drooping and the fall. She went to the ER on 29Jan2021 and the ER believed it was Bell's Palsy. She was still experiencing facial symptoms but they are improving. This consumer was administered her first dose if Pfizer COVID-19 Vaccine 22Jan2021. She reported having fell 27Jan2021. She was diagnosed with Bell's palsy in 29Jan2021 after having been seen in the emergency room. She is supposed to have the second dose/booster of Pfizer COVID-19 Vaccine on 12Feb2021. She called to ask if she should or should not still get the second dose as scheduled; and if Bell's palsy could be a reaction to the Pfizer COVID-19 Vaccine. The emergency room staff did not know how she got Bell's palsy, but knew she had the Pfizer COIVD-19 Vaccine and were kind of assuming the Bell's palsy was a reaction to the vaccine. She dis not have Bell's palsy bad. The emergency room staff thought at first she had a stroke before diagnosing her with Bell's palsy. On Wednesday, 27Jan2021 she had a friend named (Name withheld) who came over for tea. Patient has an oriental rug, and around 15:00 patient fell face first on oriental rug. She was just fine after the fall initially. She wonders if her having fell has anything to do with the Bell's palsy. She thinks it was the night of 27Jan2021 or 28Jan2021 when she asked her son if her face looked funny, did she look ok, because her face felt a little funny. She was looking in the mirror and her smile was looking crooked, and her eye looked like it was drooping. When she got up Friday, 29Jan2021 she could see her eye was drooping, and she could not blink that eye. She called her Ophthalmologist who saw her the afternoon of 29Jan2021 around 13:30-13:55. The Ophthalmologist said yeah something is going on with that eye. Her friend called his friend who is a Pediatric Neurologist that advised her to go to the emergency room. She was seen in the emergency room of (Hospital name withheld) around 17:00 on 29Jan2021. She was not admitted to the hospital at that time; but was evaluated and treated. She Bell's palsy outcome: she is doing so much better. She still has a hard time blinking her left eye, she still cannot blink her bad eye: left eye, without also closing her good eye: right eye. She is not drooling, she can drink without drooling. Her smile is still just a little crooked. She was given 2 prescriptions in the emergency room which were Prednisone and Valtrex. On 29Jan2021 in the emergency room they did tests including testing her heart with EKG; X-ray of her heart or lungs or something; took blood tests; and continuously took her blood pressure. There were no notable or abnormal results of any of those tests. They wanted her to go see her doctor last week but she did not have a chance to do so. She has an appointment with her primary doctor on Monday coming up. She has not yet seen her primary doctor about this. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None. The event Bell's palsy require a visit to Emergency Room, no to Physician Office. The patient was not hospitalized. No Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient underwent lab tests which included her heart with EKG; X-ray of her heart or lungs or something; took blood tests; and continuously took her blood pressure, all with no notable or abnormal results of any of those tests on 29Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/27/2021,5.0,UNK,ENALAPRIL; BRIMONIDINE; LEVOTHYROXINE,"Bell's palsy (Dad had Bell's palsy that might have been 30 years ago. He died at age 87 years.); Depressed mood (She is depressed sometimes, is stressed. She is the primary caregiver for her 96 year old mother.); Faint (She is a fainter/ She is a fainter, she just faints so she has a hard time getting shots. Pfizer COVID-19 Vaccine); Tiredness (Very tired/ She is almost 80 years old so she is very tired often. She is the primary caregiver)",Medical History/Concurrent Conditions: Allergy; Blood pressure high; Cataract (left) (Cataract and glaucoma in left eye); Chromosomal abnormality NOS; Diabetes; Endocrine disorder; Glaucoma (Cataract and glaucoma in left eye); Immune system disorder; Obesity (She is really overweight but she does not like the term obesity.); Respiratory disorder; Thyroid disorder,,,"['Blood pressure measurement', 'Blood test', 'Cerebrovascular accident', 'Chest X-ray', 'Electrocardiogram', 'Facial paralysis', 'Fall']",1,PFIZER\BIONTECH, 1037843,CO,53.0,F,"either tore a muscle in my lower back or herniated a disc; either tore a muscle in my lower back or herniated a disc; achey muscles, particularly in my back; muscles were really tight; Acute pain; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247), via an unspecified route of administration on 03Feb2021 12:00 (at the age of 53 years) at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) received on 13Jan2021 at 09:00 AM (at the age of 53 years) at single dose in left arm. Medical history included thyroid cancer in past, euthyroid on medication. The patient has no known allergies. Concomitant medication included Levoxythyroid 137 mcg. The patient reported the following: 'The morning after 2nd dose on 04Feb2021 at 07:00 AM, I had achey muscles, particularly in my back. My muscles were really tight. I bent down to pick something up and either tore a muscle in my lower back or herniated a disc because my muscles were so tight. Acute pain now. Cannot get out of bed'. AE resulted in doctor or other healthcare professional office/clinic visit. The patient was receiving pain meds for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The events had not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Normal thyroid function (euthyroid on medication); Thyroid cancer,,,"['Intervertebral disc protrusion', 'Muscle rupture', 'Muscle tightness', 'Myalgia', 'Pain']",2,PFIZER\BIONTECH, 1037844,TX,41.0,M,"Trouble breathing with chest pressure; Trouble breathing with chest pressure; Rash on face with swollen fingers; Rash on face with swollen fingers; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received first dose of BNT162B2 (Lot number: 9264), via an unspecified route of administration on 31Jan2021 10:15 at single dose in the left arm for covid-19 immunisation. Medical history included hypertension and penicillin allergy. The patient's concomitant medications were not reported. On 03Feb2021 09:30, the patient experienced rash on face with swollen fingers and trouble breathing with chest pressure. The events result in Emergency room/department or urgent care. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 03Feb2021. The outcome of the events was recovering. The following information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,02/03/2021,3.0,PVT,,,Medical History/Concurrent Conditions: Hypertension; Penicillin allergy,,,"['Chest discomfort', 'Dyspnoea', 'Peripheral swelling', 'Rash', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1037845,FL,27.0,F,"fever 120; vomit to dehydration point; vomit to dehydration point; a lot of discomfort; hot feeling inside of my body like I was burning; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot unknown: true) via an unspecified route of administration at arm right on 03Feb2021 at a single dose for COVID-19 immunization. The patient was not pregnant. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: brand: Pfizer; lot unknown: true) at left arm on 13Jan2021 at 04: 45 PM at a single dose for COVID-19 immunization. Other medical history included asthma and known allergies: penicillin. Concomitant medications the patient received within 2 weeks of vaccination included ascorbic acid (VITAMIN C) and multivitamins for women. No other vaccine in four weeks. 2 hours after vaccination the patient started with fever 120 (no units specified) and a lot of discomfort; early morning she had vomit to dehydration point, hot feeling inside of her body like she was burning. She went to urgency room. Treatment received for the adverse event included received electrolytes for dehydration and ondansetron (ZOFRAN, reported as Zofram). The event start date was reported on 03Feb2021 at 01:15 PM. The outcome of all events was resolving. No COVID prior vaccination and no COVID tested post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/03/2021,0.0,SEN,VITAMIN C [ASCORBIC ACID],,Medical History/Concurrent Conditions: Asthma; Penicillin allergy,,,"['Dehydration', 'Discomfort', 'Feeling hot', 'Hyperpyrexia', 'Vomiting']",2,PFIZER\BIONTECH, 1037846,MO,58.0,M,"activation of a long dormant (over 12 years) auto-immune disorder, bullous pemphigus; day 5-8 was intense GI distress with stabbing stomach pain; day 5-8 was intense GI distress with stabbing stomach pain; general malaise; Day 1-4 was significant fatigue and headache; Day 1-4 was significant fatigue and headache; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 14Jan2021 at 10:00 at a single dose on right arm for COVID-19 immunisation. Medical history included high cholesterol, blood pressure abnormal, degenerative arthritis and allergies to penicillin and NSAIDS. Concomitant medications included gabapentin, lisinopril, levothyroxine and atorvastatin. On days 1-4, the patient experienced significant fatigue and headache on 15Jan2021. On days 5-8, there was intense GI distress with stabbing stomach pain, following these events has been continued with fatigue and general malaise. Most problematic was activation of a long dormant (over 12 years) auto-immune disorder, bullous pemphigus, which attacks soft tissue areas on the body with blisters and sloughing skin. This is a very uncomfortable experience to go through. The patient's healthcare provider is aware and treating him for such. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 25Jan2021. Therapeutic measures were taken as a result of day 1-4 was significant fatigue and headache, day 5-8 was intense gi distress with stabbing stomach pain and general malaise. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/15/2021,1.0,PUB,GABAPENTIN; LISINOPRIL; LEVOTHYROXINE; ATORVASTATIN,,"Medical History/Concurrent Conditions: Allergic reaction to analgesics (allergies: penicillin, NSAIDS); Blood pressure abnormal; Degenerative arthritis peripheral joint (other_medical_history: degenerative arthritis); High cholesterol; Penicillin allergy (allergies: penicillin, NSAIDS)",,,"['Abdominal discomfort', 'Abdominal pain upper', 'Fatigue', 'Headache', 'Malaise', 'Pemphigoid', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1037847,KY,81.0,F,"Platelets dropped significantly after taking the shot. Prior to the shot my platelets were 241.; Extreme fatigue; weakness; dizziness; heart racing; nose bleeds; unable to walk or stand up without assistance; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer Biontech; lot number: unknown; lot unknown reason: true received at hospital & not sure what batch they gave her) via an unspecified route of administration at right arm on 16Jan2021 at 10:00 AM at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient was not pregnant. Facility type vaccine was at hospital. Adverse events were reported as follows: platelets dropped significantly after taking the shot. Prior to the shot her platelets were 241. Extreme fatigue, weakness, dizziness, heart racing, nose bleeds, and also was unable to walk or stand up without assistance - overall poor health. Condition intensified to severe 1-3 days after the shot and she went to the (Hospital Name) ER on 26Jan2021. She was admitted to the hospital. During that stay her platelets dropped to 142 first day there then 126 when she was released from the hospital. A week later she went to (Name) MD for a planned office visit & my platelets were tested again and her platelets how now dropped to 89. A week after this she went back to (Name) MD and her platelets dropped again and this time now 47. Prior to the shot she have no history of low platelets or this type of unusual she'll feeling. The adverse event start date was reported as on 24Jan2021. AE resulted in emergency room/department or urgent care, hospitalization for 4 days. It was unknown if treatment received for events. The outcome of events was not recovered. No covid prior vaccination. Covid test type post vaccination included Nasal Swab on 26Jan2021: negative. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/16/2021,01/24/2021,8.0,PVT,,,,,,"['Asthenia', 'Dizziness', 'Epistaxis', 'Fatigue', 'Gait inability', 'Palpitations', 'Platelet count', 'Platelet count decreased', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1037848,TX,80.0,M,"Hallucinations; He seems impaired mental and emotionally; He became unruly, hostile, angry, indignant; Unreasonable dreams; Belligerent, lost all sense of decorum, couldn't figure out where he was; Cried; This is a spontaneous report from a contactable consumer reporting for himself. A 80-years-old male patient received bnt162b2 (BNT162B2; Lot #ENS318) vaccine , via an unspecified route of administration in the left arm on 30Jan2021 11:15 at single dose for covid-19 immunisation . Medical history included Parkinson's disease, mobility decreased . Concomitant medication included thyroid (THYROID), carbidopa, levodopa (RYTARY). The patient previously took codeine and experienced drug hypersensitivity. One hour after receiving the vaccine, the patient experienced hallucinations on 30Jan2021 12:15 with outcome of recovering , he seems impaired mental and emotionally on 30Jan2021 12:15 with outcome of recovering , he became unruly, hostile, angry, indignant on 30Jan2021 12:15 with outcome of recovering , unreasonable dreams on 30Jan2021 12:15 with outcome of recovering , belligerent, lost all sense of decorum, couldn't figure out where he was on 30Jan2021 12:15 with outcome of recovering , cried on 30Jan2021 12:15 with outcome of recovering. All the reported events were considered Important Medical Events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,UNK,THYROID; RYTARY,,Medical History/Concurrent Conditions: Mobility decreased; Parkinson's disease,,,"['Abnormal dreams', 'Anger', 'Belligerence', 'Crying', 'Hallucination', 'Mental impairment']",UNK,PFIZER\BIONTECH, 1037849,GA,65.0,M,"Blood in stools the next day after getting vaccine.; This is spontaneous case from a contactable consumer reported for himself. A 65-year-old male patient received 1st dose of BNT162B2 (lot# EN5318) on 04Feb2021 00:00 (reported as 03Feb2021 12:00 PM) at single dose on Right arm for covid-19 immunization. Medical history was diabetes from Aug2018. Concomitant drug was Insulin lispro (HUMALOG) for Diabetic. Patient experienced Blood in stools the next day after getting vaccine (04Feb2021 08:15 PM). Never had this problem before. Have had colonoscopy in last 5 years with no diagnosed problems. No treatment received. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was unknown. No follow-up attempts are possible. No further information expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/04/2021,0.0,PUB,HUMALOG,,Medical History/Concurrent Conditions: Diabetes (Diagnosed with diabetes in Aug. 2018),,,"['Colonoscopy', 'Haematochezia']",1,PFIZER\BIONTECH, 1037851,VA,79.0,F,"Drooping of left cheek; Elevated blood pressure; nodes in neck enlarged; sore to touch; headache; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261, expiration date was not reported), via an unspecified route of administration on 28Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included allergies and known allergies to sulfa drugs. Patient was not pregnant at the time of vaccination. Concomitant medication included ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION), iron, colecalciferol (VITAMIN D), acetylsalicylic acid (ASPIRIN). The patient previously took first dose of bnt162b2 on 07Jan2021 09:45 on the left arm for COVID-19 immunization. The patient experienced elevated blood pressure, all nodes in neck enlarged and sore to touch, drooping of left cheek and headache on 29Jan2021 22:00. Condition persisted for 4 days. The patient received an unspecified treatment. The patient had a visit to the doctor and emergency room. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient was recovering from the events at the time of the report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,PVT,PRESERVISION; IRON; VITAMIN D; ASPIRIN,,Medical History/Concurrent Conditions: Allergy; Sulfonamide allergy,,,"['Blood pressure increased', 'Blood pressure measurement', 'Facial paralysis', 'Headache', 'Lymph node pain', 'Lymphadenopathy']",2,PFIZER\BIONTECH, 1037852,,,M,"they described it as a nasal swab and that test came back positive; they described it as a nasal swab and that test came back positive; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported similar events for 2 patients. This is the first of 2 reports. A male patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 26Jan2021, the patient did a rapid test which came negative. The patient did a 2 day test, and get the results back within a 2 days that was, they described it as a nasal swab and that test came back positive. The outcome of events was unknown. Information on lot number/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021123778 same report/drug/AE, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/26/2021,5.0,UNK,,,,,,"['Drug ineffective', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1037854,,,F,"they described it as a nasal swab and that test came back positive; they described it as a nasal swab and that test came back positive; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported similar events for 2 patients. This is 2nd of 2 reports. This consumer reported for a female patient (wife) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, they did 2 test, they did a rapid test which both of them came negative. And then they did what they call a 2 day test, could get the results back within a 2 days that was, they described it as a nasal swab and that test came back positive for both of them. The outcome of the events was unknown. Information of lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021123696 same report/drug/event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/26/2021,5.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1037855,OK,,F,"was tested for COVID and she tested positive for the virus; was tested for COVID and she tested positive for the virus; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. Medical history included cancer, she had her stomach or whatever operated on. The patient's concomitant medications were not reported. The patient was tested for covid and she tested positive for the virus on 24Jan2021, she felt terrible, but she was still just in her home, with like a plastic covering over her door. She was instructed to just take paracetamol (TYLENOL) and Zinc. The outcome of the events was unknown. Information on lot number/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/24/2021,10.0,UNK,,,Medical History/Concurrent Conditions: Cancer; Surgery,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1037856,TN,,F,"attempted to kill herself; acting differently; This is a spontaneous report from a Pfizer Sponsored Program . A contactable consumer (patient's parent) reported a female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization this morning (03Feb2021). Medical history included: autism, depression and anxiety. Concomitant medication was not reported. The patient experienced acting differently and she attempted to kill herself after the first dose of the vaccine today (03Feb2021). Action taken for BNT162B2 was not applicable. Outcome of the events was unknown. Information on Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Anxiety; Autism; Depression,,,"['Abnormal behaviour', 'Suicide attempt']",1,PFIZER\BIONTECH, 1037861,IL,47.0,M,"I was dizzy all along and almost fainted; I was dizzy all along and almost fainted; migraine; This is a spontaneous report from a contactable consumer (patient). This 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 20Jan2021 for COVID-19 immunization. Medical history included sleep apnea; high blood pressure; high cholesterol; borderline diabetes. Concomitant medications included losartan; alirocumab (PRALUENT, injection) on 20Jan2021. Since 23Jan2021, patient was dizzy all along and almost fainted and was still having symptoms of mild migraine and he don't know like some light sensitivity. Doctor believed it was from vaccine. Patient was wondering how long was this going to be last as he had second shot coming out. He didn't think it was an adverse reaction and he thought he should get the second shot. But this was continuing to me and it had already been two weeks and patient still having symptoms of mild migraine. Patient was worried about taking the second shot as a result. He had never had a migraine before and was told it was probably from the vaccine and that was not something he wanted to hear. Patient wanted to know if this was normal to still be having this side effect for this long. Patient was taking acetaminophen (for migraine), it was not a TYLENOL, it was from a different brand. Patient did liver and cholesterol test and blood test in Jan2021 at Cardiologist and they came back fine, nothing was found there. The outcome of event migraine was not resolved. The outcome of rest events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/23/2021,3.0,UNK,LOSARTAN; PRALUENT,,Medical History/Concurrent Conditions: Blood pressure high; Borderline diabetes; High cholesterol; Sleep apnea,,,"['Blood cholesterol', 'Blood test', 'Dizziness', 'Liver function test', 'Migraine', 'Syncope']",1,PFIZER\BIONTECH, 1037865,FL,89.0,M,"respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed/died on 09Feb2021 from respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed/died on 09Feb2021 from respiratory failure from COVID19; This is a spontaneous report from a contactable physician. An 89-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 10Jan2021 at 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient received one dose of Pfizer vaccine on 10Jan2021. The patient was presented to the ER with COVID symptoms and was diagnosed on 27Jan2021. Patient subsequently died on 09Feb2021 from respiratory failure from COVID19. It was unknown if autopsy was done. The patient was tested for COVID post vaccination via nasal swab: covid-19 virus test positive on 27Jan2021. The events resulted in emergency room/department or urgent care, hospitalization, and patient died. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID post vaccination and respiratory failure with fatal outcome, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. More information on the underlying medical condition in this 89-year-old male patient is required for the Company to make a more meaningful causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.; Reported Cause(s) of Death: presented to the ER with COVID symptoms and was diagnosed on 27Jan. Patient subsequently died on 09Feb from respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed on 27Jan. Patient subsequently died on 09Feb from",Yes,02/09/2021,Not Reported,Yes,,Not Reported,N,01/10/2021,01/27/2021,17.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'Respiratory failure', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1037866,TX,34.0,M,"Premature ventricular contractions; Postural Orthostatic tachycardia syndrome; Dizziness; shortness of breath; chest pain; This is a spontaneous report from a contactable physician (patient). A 34-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EL0140, in Hospital, via an unspecified route of administration in left arm, on 22Dec2020 (at 34 years of age) at single dose for COVID-19 immunization. Medical history included prediabetes (glucose tolerance impaired) from an unknown date. The patient didn't have COVID-19 prior to vaccination. Concomitant medication included metformin and multivitamins. On 09Jan2021 the patient experienced premature ventricular contractions, postural orthostatic tachycardia syndrome, dizziness, shortness of breath and chest pain. The events resulted in Emergency room/department or urgent care access and hospitalization as life threatening events. The patient was treated with diltiazem, fludrocortisone, aspirin and atorvastatin. He remained in hospital 2 days and then he was discharged. The patient underwent COVID-19 test (nasal swab) on 12Jan2021 and 13Jan2021 and both gave negative results. The patient had not recovered yet from the reported events at the time of the report.; Sender's Comments: The causal relationship between BNT162B2 and the events ventricular extrasystoles, postural orthostatic tachycardia syndrome, dizziness, dyspnea and chest pain cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. The patient is a young adult with known prediabetes, but no other comorbidities reported. Information on tests done during admission, clinical course and working diagnosis would be helpful in further assessment of this case. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Yes,Yes,2.0,Not Reported,N,12/22/2020,01/09/2021,18.0,PVT,METFORMIN,,Medical History/Concurrent Conditions: Prediabetes,,,"['Chest pain', 'Dizziness', 'Dyspnoea', 'Postural orthostatic tachycardia syndrome', 'SARS-CoV-2 test', 'Ventricular extrasystoles']",1,PFIZER\BIONTECH, 1037867,,,F,"Caller's mother received both doses of the Pfizer covid vaccine; within a month of receiving the vaccine, the caller's mother died.; This is a spontaneous report from a contactable consumer reported for the mother. A female patient of unknown age received both doses of vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unknown dates at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. Within a month of receiving the vaccine, the patient died. It was unknown if an autopsy was performed. Information on the Lot/Batch number has been requested ; Reported Cause(s) of Death: within a month of receiving the vaccine, the caller's mother died",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],2,PFIZER\BIONTECH, 1037868,CA,73.0,F,"At 4am I woke up sweating/sweating profusely; nausea/extremely nauseous; dizziness/dizzy/extremely dizzy; vomit; lost bladder control; I was very weak, I couldn't wipe. I couldn't hold a cloth/had no hand strength; terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life; a little arm pain; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at deltoid left on 26Jan2021 at 13:20 (at the age of 73 years) at single dose for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. The patient reported a little arm pain on 26Jan2021, I woke up sweating/sweating profusely, nausea/extremely nauseous, dizziness/dizzy/extremely dizzy and vomit , all on 27Jan2021 at 4:00; lost bladder control, terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life, and those are classic heart attack symptoms, she had no cardio and respiratory symptoms; I was very weak, I couldn't wipe. I couldn't hold a cloth/had no hand strength, all on 27Jan2021. Therapeutic measures were taken as result of little arm pain an included treatment with aspirin. The patient outcome of the events was recovered. The information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Bladder disorder', 'Dizziness', 'Hyperhidrosis', 'Nausea', 'Near death experience', 'Pain in extremity', 'Vomiting']",1,PFIZER\BIONTECH, 1037869,NC,,M,"Fever; unresponsive; This is a spontaneous report from a non-contactable consumer. An elderly male patient received the second BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 11Feb2021 for covid-19 immunisation . The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On 12Feb2021, the patient developed fever, unresponsive. The events required a visit to the emergency room. The patient was hospitalized and condition was life threatening. Therapeutic measures were taken as a result of fever and unresponsive. The outcome of the events was not recovered. No follow-up attempts are possible; information on lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Yes,Yes,,Not Reported,N,02/11/2021,02/12/2021,1.0,UNK,,,,,,"['Body temperature', 'Pyrexia', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH, 1037870,CA,60.0,M,"Double Covid Pneumonia; feeling tired; weak; doctors were concerned that the Covid vaccine had taxed his immune system; This is a spontaneous report from a contactable consumer (patient; a direct care staff for a group home). A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 613247, expiration date: May2021), intramuscularly to the left arm on 21Jan2021 at 0.3 mL, single for COVID-19 immunization. He was given the vaccine at work. It's a group home facility. The patient's medical history included high blood pressure, and positive for the covid virus from 09Jan2021 to an unknown date. Concomitant medication included benazepril from 22Jan2021 and ongoing for high blood pressure. He saw a doctor on 22Jan2021 and he prescribed Benazepril; it was started on 22Jan2021. The patient previously received a flu vaccine on Sep2020 for immunization. The patient called about the Covid vaccine. He reported that on 09Jan2021, he was positive for the COVID virus. He was then cleared on 16Jan2021 to go to work. His work then offered the COVID vaccine on 21Jan2021 and he got it. Then on 29Jan2021, he was diagnosed with Double Covid Pneumonia. His doctors were concerned that the Covid vaccine had taxed his immune system. The patient was a direct care staff for a group home. He cares for adults that are developmentally challenged. He has a CPR license. The patient confirmed that he received his first dose of the vaccine on 21Jan2021. He started feeling tired and weak about evening of 22Jan2021. He then started feeling out of breath Wednesday 27Jan2021, 28Jan2021 Thursday, and Friday 29Jan2021. He thought maybe he might be having a normal side effect. He stated that the Double Covid Pneumonia was detected on the X-ray that took place on the 29Jan2021. He is scheduled for second dose on 11Feb2021. The patient stated that the weakness was horrible. They gave him antibiotics; he was starting to recover. He was off of work till Saturday due to the pneumonia. He doesn't know if he will be getting the second dose. The patient was prescribed antibiotic Cefuroxime Axetil 500mg 1 tablet by mouth twice a day for 7 days, antibiotic Doxycycline Monohydrate 100mg 1 tablet by mouth twice a day 7 days, a Steroid Prednisone 20mg 2 tablets by mouth daily at same time in morning for 5 days, and a breather Albuterol HFA 90mcg/att inhale 2 puffs by mouth every 4 hours as needed for shortness of breath, wheezing, or cough. It was reported that they did a Covid Nasal Swab Test on 09Jan2021, then on that Sunday or Monday he got positive result, and by that time he had fatigue. After he got the vaccine, he went back to work. After the vaccine, it was a big surprise about the double Covid pneumonia, and they think it was taxing the immune system. He has had no issues with vaccines in the past. He had a Flu vaccine recently and there was no problem, that was Sep2020. He wants to know should he get the second dose.The outcome of the events double Covid pneumonia and ""doctors were concerned that the Covid vaccine had taxed his immune system"" was unknown. Regarding his double Covid pneumonia, the doctor said his O2 level will determine how he is doing. They will also do another lung X-ray. The doctor said the antibiotic should take care of it. The doctor did warn him that things could get worse. They said he can possibly go back to work on 06Feb2021, but this is not certain at the moment; it could change.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/01/2021,,PVT,BENAZEPRIL,,Medical History/Concurrent Conditions: Blood pressure high; COVID-19 virus test positive,,,"['Asthenia', 'COVID-19 pneumonia', 'Fatigue', 'Immune system disorder', 'SARS-CoV-2 test', 'X-ray']",1,PFIZER\BIONTECH,OT 1037871,MA,92.0,F,"faint; slightly dizzy; weak; This is a spontaneous report from a contactable nurse (patient). A 92-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL9262), intramuscular in the left arm on 01Feb2021 12:30 at a single dose for covid-19 immunization. The patient has no medical history and concomitant medications. On 02Feb2021 16:00, the patient faint, slightly dizzy, weak and had to grab counter. Within 5-10 minutes it was gone and she was feeling fine. The patient added that it would have been serious if she hit the floor, but she did not. The outcome of the events was recovered on 02Feb2021.; Sender's Comments: Based on the close temporal relationship, the association between the events faint, slightly dizzy and weak with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/02/2021,1.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Dizziness', 'Syncope']",1,PFIZER\BIONTECH,OT 1037872,,,F,"deafened her for ten minutes; This is a spontaneous report from a contactable consumer patient. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient got the vaccine on an unspecified date and it deafened her for ten minutes. She was not sure if that was a side effect that she should be worried about. The patient recovered from the event on an unspecified date. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,['Deafness'],UNK,PFIZER\BIONTECH, 1037873,MD,73.0,M,"High pulse rate; Blood pressure low; Sweating; Clammy; wasn't feeling well; Chills; feeling feverish without having a fever; Fatigue/Tiredness; irregular heartbeat; he said the nausea started later on Friday evening; he had a sore right arm after getting the COVID-19 Vaccine; He said he already has stomach trouble; pain in his chest.; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date not reported), via an unspecified route of administration in the right arm on 29Jan2021 at single dose for COVID-19 immunization. The patient was vaccinated at a hospital. Medical history included heart rate irregular and blood pressure high. Concomitant medications were none. The patient said he had an irregular heartbeat after getting his first dose of the COVID-19 Vaccine on Friday, 29Jan2021. He said he had to go to the Emergency Room on Sunday, 31Jan2021. He clarified he checked his blood pressure at home and his blood pressure was low at 91/73. He said he also had a high pulse rate of 160, or better, for 9-1/2 hours. He said the only thing he can attribute his low blood pressure and high pulse rate to is the COVID-19 Vaccine. He said he hasn't heard anything about the COVID-19 Vaccine being related to having an effect on the heart, but he personally believes it was his first COVID-19 Vaccine dose that caused his low blood pressure and high pulse rate. He clarified after receiving the COVID-19 Vaccine on Friday, 29Jan2021, he had a sore right arm after getting the COVID-19 vaccine, fatigue, tiredness, and nausea. He said on Saturday, 30Jan2021, he wasn't feeling well. He said he recognized a small amount of chills, feeling feverish without having a fever, and sweating. He said his wife checked his temperature a few times on Saturday, 30Jan2021, and he never had a fever, but he felt clammy. He said he had noticed the nausea more than anything else. He said he maybe should have checked his blood pressure on Saturday, 30Jan2021. He said he didn't check his blood pressure until Sunday morning, 31Jan2021, and when he saw his low blood pressure and high pulse rate, he called the hospital and eventually drove to the Emergency Room. He said by the time he had got to the Emergency Room his blood pressure had went up to ""100 and something"", but his pulse rate never changed, and his pulse was still 160. He said the doctor gave him several medications to try to get his pulse rate to come down. He said the doctor had given him a medication that was supposed to bring his pulse down. He said then the doctor had to add something else in a syringe to go with the other medication to bring his pulse down. He said he wasn't sure of the medication's name. He clarified he never noticed his pulse rate was high until he took his blood pressure on Sunday, 31Jan2021. He said he felt the nausea start later Friday evening (29Jan2021). He said he already has stomach trouble anyways that he takes medicine for, so he took a pill, but the nausea continued. He clarified he took 1 Omeprazole 20mg capsule that was dispensed in a pharmacy bottle, but stated the Omeprazole 20mg prescription looked like it expired in 2017. He said he knows he has a newer Omeprazole prescription, but did not know where the prescription bottle was. He reported on Saturday, 30Jan2021, he just laid around. He said he did not feel as bad on Saturday, as he did on Sunday, 31Jan2021. He said he called the Emergency Room on Sunday morning, and went to the Emergency Room. He said he didn't feel his 160 pulse rate. He said he was told by the doctor in the Emergency Room that his fast heart rate had his heart beating like he was having a stress test. He reported he doesn't know if he wants to get the second COVID-19 Vaccine shot after what he experienced this past weekend. He reported he only takes blood pressure medicine that he has been on for a while. He reported he had several EKGs done on Sunday, 31Jan2021, while he was in the Emergency Room. He said the EKG showed Atrial Fibrillation/flutter with a heart rate in the 160s. He reported while he was in the Emergency Room he was given IV Heparin, IV Potassium, Potassium pills, and Amiodarone in a pill and IV form. He said the doctor added another IV medicine in a syringe, but he doesn't know the name of the medicine. He said the doctor also gave him IV Morphine because he had pain in his chest. He said the doctor said his chest pain was being caused by his heart trying to go back into a regular rhythm. He reported he was in the Emergency Room for 11-12 hours before he was admitted to the hospital. He said his pulse rate wasn't coming down and stayed at 160 for 9-1/2 hours. He said the doctor wanted to admit him to the hospital, so he could have a procedure to make sure the high pulse rate didn't damage his heart. He said on Monday, 01Feb2021, he had a procedure where they went through his wrist and put a dye in his heart to see if the stress from his high pulse rate damaged his heart. He said his heart wasn't damaged, so he was discharged from the hospital later in the day on 01Feb2021. He clarified his blood pressure was good by the time the first or second EKG was performed in the Emergency Room. He clarified he already had an issue with sweating before he received his first dose of the COVID-19 Vaccine. He said he is still sweating, but he doesn't know if that is because of the COVID-19 vaccine. Clinical outcome of high pulse rate and blood pressure low was recovered on 31Jan2021; nausea, fatigue/tiredness recovered on 02Feb2021; chills, feeling feverish recovered on an unspecified date; sweating was not recovered; while for the other events was unknown.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/29/2021,01/29/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure high; Heartbeats irregular,,,"['Blood pressure measurement', 'Chest pain', 'Chills', 'Cold sweat', 'Electrocardiogram', 'Fatigue', 'Gastric disorder', 'Heart rate', 'Heart rate increased', 'Heart rate irregular', 'Hyperhidrosis', 'Hypotension', 'Malaise', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH, 1037874,AK,68.0,F,"fluttering heart; Started light headed; sharp chest pain; hard to take a breath; Face turned hot and bright red/Felt like my head was on fire; Body ache all night; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265, expiry date: unknown), via an unspecified route of administration on 02Feb2021 at single dose (Right arm) for COVID-19 immunization. Medical history included Mild Asthma and Known allergies: Penicillin, Sulfa, Levoquin. Patient is not pregnant. Concomitant medication included prednisone (short course). The patient previously took bnt162b2 for COVID-19 immunization {product=COVID 19, brand=Pfizer,lot number=EJ1686, lot unknown=False, administration date=12Jan2021, vaccine location=Right arm, dose number=1}. It was reported that the patient started light headed, then sharp chest pain, fluttering heart, hard to take a breath. Face turned hot and bright red. Felt like my head was on fire. Body ache all night. Started happening about 3 hours after vaccine dose. Events started on 02Feb2021 13:00. Did not go to ER, no treatment. Stayed home and rested. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,UNK,PREDNISONE,,Medical History/Concurrent Conditions: Asthma; Penicillin allergy; Sulfonamide allergy,,,"['Cardiac flutter', 'Chest pain', 'Dizziness', 'Dyspnoea', 'Feeling hot', 'Pain']",2,PFIZER\BIONTECH, 1037875,PA,76.0,M,"dizzy; nauseous; left arm weakness/left leg weakness; numbness and tingling of his left fingers; numbness and tingling of his left fingers; lost balance; fell; This is a spontaneous report from a contactable physician. A 76-year-old male patient received 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: 59267-1000-1) intramuscular at left arm on 02Feb2021 at 11:00AM at a single dose for COVID-19 immunization. Medical history included closed fracture of patella, coronary atherosclerosis, essential hypertension, malignant neoplasm of prostate, and known allergies: acetominophen, doxycycline, oxycodone-acetominophen, oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: 59267-1000-1) intramuscularly at left arm on 12Jan2021 at 12:00PM for COVID-19 immunization. Other medications in two weeks included omeprazole (PRILOSEC, strength: 20 mg), CPD losartan potassium (COZAAR, 25 mg, tablet), simvastatin (strength: 20 mg, tabs), hydrochlorothiazide (strength: 25 mg, tabs). No other vaccine in four weeks. Facility type vaccine was at Doctor's office/urgent care. Adverse events were reported as follows: 20min after getting the 2nd dose, the patient became dizzy and nauseous. 20 min after that the patient developed left arm weakness and numbness and tingling of his left fingers. When trying to get out of his car, he lost balance and fell. He had no loss of consciousness or head trauma. He had progressively worsening left arm and left leg weakness. Adverse event start date was reported on 02Feb2021 at 11:30AM. AE resulted in Emergency room/department or urgent care, hospitalization for 3 days. Treatment received for AE included baclofen and methylprednisolone. The outcome of events was not recovered. No covid prior vaccination. Covid tested post vaccination included Nasal Swab (NAAT) on 02Feb2021 was negative.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/02/2021,02/02/2021,0.0,PVT,PRILOSEC [OMEPRAZOLE]; COZAAR; SIMVASTATIN; HYDROCHLOROTHIAZIDE,,Medical History/Concurrent Conditions: Closed fracture of patella; Coronary atherosclerosis; Essential hypertension; Malignant neoplasm of prostate,,,"['Balance disorder', 'Dizziness', 'Fall', 'Hypoaesthesia', 'Muscular weakness', 'Nausea', 'Paraesthesia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,OT 1037877,TN,80.0,M,"fell and broke his hip; fell and broke his hip; tested positive for COVID-19; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as Pfizer COVID-19 vaccine, lot EL1283, expiry date 30Apr2021), intramuscular in right arm on 22Jan2021 10:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included ongoing Parkinson's disease diagnosed in Jan 2018 and the Neurologist said that the patient probably had it for 6-8 years; ongoing hypertension (its been years); had cardiac and thyroid disorder. The patient was on unspecified medication for his thyroid. The patient fell and broke his hip on 02Feb2021 08:30 and was hospitalized. It was reported that he will have a surgery. The patient underwent laboratory test Sars-cov-2 test: positive on 02Feb2021, weight: 170-175 lbs on unknown date. He also had an echocardiogram a couple of weeks ago (2021) because he was seeing a new heart doctor. The doctor did say that he had a mild leaky aorta and will continue just the medication he was on. He was scheduled to receive the second vaccine on 12Feb2021. The outcome of events was unknown. No further details were provided or obtained.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/22/2021,02/02/2021,11.0,PVT,,Blood pressure high; Parkinson's disease,Medical History/Concurrent Conditions: Cardiac disorder; Thyroid disorder,,,"['COVID-19', 'Echocardiogram', 'Fall', 'Hip fracture', 'SARS-CoV-2 test', 'Weight']",1,PFIZER\BIONTECH,OT 1037878,OH,70.0,M,"Is patient deceased: Yes; Low pulse; This is a spontaneous report from two contactable nurses reporting for a patient. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0140 expiration date Mar2021) intramuscular on 22Dec2020 at 10:30 at single dose in right arm for COVID-19 immunisation. The patient was vaccinated at Nursing Home. Patient age at time of vaccination was 70 years. Patient's Medical History included ongoing Type 2 Diabetes Mellitus Without Complication onset date: admission 22Oct2020, ongoing morbid obesity due to excess calories onset date: admission 22Oct2020, cardiac disorder, essential hypertension, hypertension, schizophrenia, hyperlipidemia, benign prostatic hyperplasia (BPH), Gastrooesophageal reflux disease (GERD), depression, hypothyroid, epilepsy, pain, dry eyes, anxiety, restlessness, 17Jan2020 Slid out of chair to floor, no injury, on 27Jan2020, 28Jan2020, 29Jan2020 diarrhea noted. Concomitant medications included acetylsalicylic acid (ASPIRIN EC) for Cardiac Health, atenolol (ATENOLOL) for Essential Hypertension, atorvastatin calcium (ATORVASTATIN CALCIUM) for hyperlipidemia, finasteride (FINASTERIDE) for benign prostatic hyperplasia, tamsulosin hydrochloride (FLOMAX) benign prostatic hyperplasia, insulin glargine (LANTUS) for diabetes mellitus, lithium carbonate (LITHIUM CARBONATE) for Schizophrenia, losartan potassium (LOSARTAN POTASSIUM) for hypertension, lurasidone hydrochloride (LURASIDONE HYDROCHLORIDE) for Schizophrenia, omeprazole (OMEPRAZOLE) for gastrooesophageal reflux disease, sertraline hcl (SERTRALINE HCL) for depression, levothyroxine sodium (SYNTHROID) for hypothyroid, ergocalciferol (VIT D) for supplement, haloperidol (HALOPERIDOL) for Schizophrenia, levetiracetam (KEPPRA) for epilepsy, paracetamol (TYLENOL EXTRA-STRENGTH) for pain, propylene glycol (ARTIFICIAL TEARS) for dry eyes, lorazepam (ATIVAN) for a anxiety or restlessness. As antipyretic use was reported Tylenol ES (500 mg) Tab, 2 Tabs by Mouth Routine use three times a day given at time of vaccination and after. It was reported the patient was Covid+. He was tested on 21Dec2020 and was not admitted to hospital. Event Onset Date was reported as 24Dec2020 (clarification pending). On 30Dec2020 the patient was started on O2 at 2L for low pulse. O2 was increased over time to eventually O2 at 8L on 03Jan2021. Morphine Sulfate was started on 03Jan2021 at 5 mg sl/by mouth every 2 hours as needed for pain or airhunger. The patient deceased on 03Jan2021. The cause of death was unknown. It was not reported if an autopsy was performed. The AEs did not require a visit to Emergency Room or Physician Office. Outcome of Low pulse was unknown.; Sender's Comments: Based on the information available the events Death (unknown cause) and Heart rate decreased are attributed to patient's multiple underlying medical conditions including Type 2 Diabetes Mellitus, morbid obesity, cardiac disorder, hypertension, epilepsy etc. However, based solely on a vaccine-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the above mentioned events cannot be completely excluded. The case will be reevaluated should additional information, including the cause of death, become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Is patient deceased: Yes",Yes,01/03/2021,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/30/2020,8.0,SEN,ASPIRIN EC; ATENOLOL; ATORVASTATIN CALCIUM; FINASTERIDE; FLOMAX [TAMSULOSIN HYDROCHLORIDE]; LANTUS; LITHIUM CARBONATE; LOSARTAN POTASSIUM; LURASIDONE HYDROCHLORIDE; OMEPRAZOLE; SERTRALINE HCL; SYNTHROID; VIT D; HALOPERIDOL; KEPPRA; TYLENOL,Morbid obesity (Onset Date: Admission 22Oct2020); Type 2 diabetes mellitus (Onset Date: Admission 22Oct2020),Medical History/Concurrent Conditions: Anxiety; BPH; Cardiac disorder; COVID-19 virus test positive; Depression; Diarrhea; Dry eyes; Epilepsy; Essential hypertension; Fall; GERD; Hyperlipidemia; Hypertension; Hypothyroidism; Pain; Restlessness; Schizophrenia,,,"['Death', 'Heart rate', 'Heart rate decreased', 'Oxygen saturation', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH,OT 1037879,WA,62.0,F,"The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperature; Difficulty remembering things; Vomiting; Headache 10/10; developed a red area below injection site/The site got worse through Thursday and was red, hot; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in right deltoid on 24Jan2021 at a single dose for prevention (COVID-19 immunization). Medical history included Low immunoglobulin/compromised immune status/Low immunoglobulin diagnosed 8 years ago, hereditary angioedema from 2010, asthma diagnosed in her 20's, Allergic to Thermarisol, diagnosed allergies, respiratory illness, and endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (LOT number: EJ1686) in right deltoid on 03Jan2021 for covid-19 immunization, and flu shot on Sep2020 without adverse event. She got second injection on 24Jan2021. On 25Jan2021, she woke up with 100.5 degrees temperature and could not stop vomiting. She had to go to the ER. They gave her Zofran, IV and also Toradol because she had a number 10 headache. She continued with low grade temperature throughout week from 99.5-100.5 degrees Fahrenheit, and by Tuesday morning, she developed a red area below injection site. By Thursday, there was a red area growth to 13 cm x 15.5 cm on the injection site. She could not remember her email address and said her brain was not thinking. This started after the vaccine that she began having difficulty remember things. She never had a headache that bad. It improved but she has a lingering headache still. She continued to have a temperature from Monday to Saturday. Currently, she does not have an elevated temperature. Difficulty remembering things was reported as just irritating, but significant. The site got worse through Thursday and was red, hot and ended up measuring 13 cm x 15.5 cm. Regarding weakness, she could walk but medics had to help support from her seat to the ambulance. The outcome of the events red and hot injection site was not recovered; the outcome of the events vomiting, headache, weakness was recovering. The outcome of difficulty remembering things was unknown. The outcome of high temperature was recovered on an unknown date. The events was assessed as medically significant.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and the use of BNT162B2 cannot be excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/25/2021,1.0,UNK,,,"Medical History/Concurrent Conditions: Asthma (Verbatim: Asthma/Asthma diagnosed in her 20's); Diabetes (endocrine abnormalities (including diabetes)); Drug allergy; Endocrine disorder (endocrine abnormalities (including diabetes)); Hereditary angioedema; Immunoglobulins decreased (Verbatim: Low immunoglobulin/compromised immune status/Low immunoglobulin diagnosed 8 years ago.); Obesity (endocrine abnormalities (including diabetes) and obesity:); Respiratory abnormality, unspecified",,,"['Asthenia', 'Body temperature', 'Headache', 'Memory impairment', 'Pyrexia', 'Vaccination site erythema', 'Vaccination site warmth', 'Vomiting']",2,PFIZER\BIONTECH,OT 1037880,,50.0,M,"delirium; Fever of 100.8; chills; flushed; overall soreness; deltoid pain; This is a spontaneous report from a non-contactable consumer. A 50-year-old male patient received BNT162B2 (lot# unknown) on 03Feb2021 01:30 PM at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient experienced Fever of 100.8, chills, flushed, overall soreness, delirium, and deltoid pain on 04Feb2021 04:00 AM with outcome was Recovering. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,UNK,,,,,,"['Body temperature', 'Chills', 'Delirium', 'Flushing', 'Myalgia', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1037915,CA,31.0,F,"Red rash all over body; Hives on legs, butt, stomach, lower stomach, arms, hands, feet, face, neck and back; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL4262), via an unspecified route of administration in the left arm on 27Jan2021 at 14:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 29Jan2021 at 15:00, the patient experienced red rash all over body and hives on legs, butt, stomach, lower stomach, arms, hands, feet, face, neck and back. The events required a visit to the emergency room and physician's office. The patient was treated with methyprednisolone (MANUFACTURER UNKNOWN), epinephrine (MANUFACTURER UNKNOWN), and diphenhydramine (MANUFACTURER UNKNOWN). The clinical outcomes red rash all over body and hives were not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/29/2021,2.0,PUB,,,,,,"['Rash erythematous', 'Urticaria']",1,PFIZER\BIONTECH, 1037922,TX,70.0,F,"shingles/I've had shingles before, this was the 4th time; shingles/I've had shingles before, this was the 4th time; kidney infection; hurting on my waist around the back; diverticulitis; Her blood pressure went up to 211/92; does not feel well; afraid of taking it if it will be any worse; sick; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot: EL3248, expiry 30Apr2021), intramuscular on 23Jan2021 08:15 at a single dose in the left arm for COVID-19 immunization (prevention because she has autoimmune). Medical history included Behcet's syndrome and Sjogren's syndrome, both are overactive immune system problem/autoimmune diseases, which were diagnosed 20 years ago; diagnosed allergies; compromised immune status; respiratory illness; genetic chromosomal abnormalities; endocrine abnormalities (including diabetes) and obesity; and patient have had shingles before. Family history was reported as none. Concomitantly, she was just taking daily medications that were not relevant. There was no prescriber for the vaccine. It was through a hospital. It was reported that vaccination was given at 08:15 to 08:30. Patient had no history of previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered the same date of the Pfizer suspect. Patient had not had prior vaccinations (within 4 weeks). Patient received her first dose of the Pfizer vaccine on Saturday 23Jan2021. She stated, on Tuesday 26Jan2021, patient was hurting on the waist around the back. On Wednesday, 27Jan2021, that next morning, she went to see her internal doctor and they thought a kidney infection or not; he was not sure if she had a kidney infection or what was going on. Patient went home and it got worse and patient went to the ER (Jan2021), also reported as ended up going to the ER. They did a CT scan gave her medicine. They did a CT scan and said it was not her bladder or anything (Jan2021). They thought it was diverticulitis; nothing helped. They gave her medication and she kept getting sick (2021). No further details provided on medication given. On Friday, 29Jan2021, early morning, patient went back to the ER, they did another CT with contrast it wasn't diverticulitis, but it was shingles, and patient have had shingles before, this was the 4th time. It was reported that when the doctor came in, he thought this was shingles and she has had shingles previously. She has had it about 3 other times and the pain was just off the scale (Jan2021). Her blood pressure went up to 211/92 and they were giving her morphine for the pain (Jan2021). She was questioning if she should get the second dose. She has two autoimmune diseases and it was an overactive immune disease. She took the one vaccine and her doctor said to contact Pfizer being as it is kind of new and especially since she has the autoimmune issues. She would like to know if it is safe for her to have the second vaccine. She does not know if she will be over this. She does not feel well (Jan2021). She was afraid of taking it if it will be any worse (Jan2021). Patient felt all right until she had the vaccine, on Tuesday the problem started (26Jan2021). They were giving her medication for the shingles and for the pain. Patient stated that ""it set something off"". Patient was still sick (2021), still taking pain pills. Patient didn't know how many days she has. Her second vaccine is on 13Feb2021. As sick as she has been, and her overactive immune system and if she still has the shingles those can last a long time, she doesn't want to go through what she went through. This was a lot of pain and with shingles they can last, 6 months or a year. The nurse called her back and told her to report to Pfizer. Patient was taking the medicine for the shingles right now. She doesn't know what will happen. She doesn't want to be sick. Patient asked for the efficacy after 1 dose and how much protection it has. She did fill out something because she talked with someone else. She confirmed it was through VAERS and not with Pfizer. She said the pain around her waist was a little better because they gave her the medicine for shingles and she has pain pills. She said one was Valacyclovir and she could not remember the name of the other. Patient had required two trips to ER. First one was on 27Jan2021 and went to internal medicine doctor and that night went to the ER. They did CT scan and it was not bladder or anything. Second visit on 29Jan2021 and did CT with contrast and the doctor thought it was shingles since she had shingles three times before. She has had them internally. The doctor said it would not necessarily need to be externally break outs. The next two times she did not break out. She did not have anything around her waist. Therapeutic measures were taken as a result of the events hurting on my waist around the back, kidney infection, diverticulitis, shingles, and sick. The outcome of the event hurting on my waist around the back was recovering. The outcome of the event kidney infection, diverticulitis, shingles, sick, blood pressure went up to 211/92, does not feel well, and ""afraid of taking it if it will be any worse"" was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/01/2021,,PVT,,,Medical History/Concurrent Conditions: Allergy; Behcet's disease (Bechet's and Sjogrens.Both diagnosed 20 years ago.); Chromosomal abnormality NOS; Diabetes; Endocrine disorder; Immune imbalance; Obesity; Respiratory disorder; Shingles (he thought this was Shingles and she has had shingles previously.); Sjogren's (Bechet's and Sjogrens.Both diagnosed 20 years ago.),,,"['Blood pressure measurement', 'Computerised tomogram', 'Disease recurrence', 'Diverticulitis', 'Fear', 'Herpes zoster', 'Hypertension', 'Illness', 'Kidney infection', 'Malaise', 'Pain', 'Pain assessment']",UNK,PFIZER\BIONTECH,OT 1037928,,,U,"positive for COVID-19; positive for COVID-19; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was positive for COVID-19 on an unspecified date after the first dose of vaccine. Outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1037931,,,M,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a non-contactable consumer (patient) reported that an adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Not available) first dose via an unspecified route of administration on an unspecified date at single dose and second dose via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization in hospital. The patient's medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has contracted COVID after second dose administered in Jan2021. Also reported that 10 + of his colleagues at the hospital had symptomatic COVID after receiving second dose of the vaccine. Event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events. The patient considered the events as non-serious. Patient had COVID test positive in Jan2021 post vaccination. The outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/01/2021,,OTH,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1037936,,,F,"Monday I felt like I had sinus issues.; I have now tested positive; I have now tested positive; on Sunday I started having some chills and sniffles; on Sunday I started having some chills and sniffles; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on Sunday, 31Jan2021, the patient started having some chills and sniffles. On Monday, 01Feb2021, the patient felt like she had sinus issues. On Tuesday, 02Feb2021, a friend said they were tested positive and recommended she get tested. The patient reported that she now tested positive in Feb2021. Patient was asking what to do about her second dose. Outcome of events was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/31/2021,2.0,UNK,,,,,,"['COVID-19', 'Chills', 'Drug ineffective', 'Rhinorrhoea', 'SARS-CoV-1 test', 'Sinus disorder']",1,PFIZER\BIONTECH, 1037938,KY,90.0,F,"SARS-Cov2-RT PCR tested positive; SARS-Cov2-RT PCR tested positive; This is a spontaneous report from a contactable nurse. A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) intramuscularly on 13Jan2021 at single dose for covid-19 immunisation. Medical history included dementia. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had been tested for COVID-19, patient underwent covid test type post vaccination nasal swab, SARS-Cov2-RT PCR on 01Feb2021, result was positive. The reporter considered all events was non-seriousness. There was no treatment received for the adverse events. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and SARS-CoV2-RT PCR test positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,02/01/2021,19.0,SEN,,,Medical History/Concurrent Conditions: Dementia,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1037946,NV,45.0,F,"First dose administration on 19Dec2020 and second dose administration on 12Jan2021; Dyspnea; Rash; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; This is a spontaneous report from a contactable healthcare professional (the patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283, expiration date not reported), via an unspecified route of administration (left arm) on 12Jan2021 at a single dose, for COVID-19 immunization. Medical history was not reported. Concomitant medication included cefalexin monohydrate (KEFLEX), cefdinir, fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC ALLERGY), and triamcinolone. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5760, on right arm, on 19Dec2020, and experienced urticaria and folliculitis with severe exacerbation after both vaccination. It was reported that on Jan2021, the patient was under successful treatment for urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; experience of rash and dyspnea on Jan2021 required steroids and epipen. Treatment included Prednisone course, epipen, and H2 blockers. The adverse event resulted in a doctor or healthcare professional office/clinic visit. The patient's labs on an unknown date was negative for autoimmune disease. It was also reported that the patient had first dose administration on 19Dec2020 and second dose administration on 12Jan2021. The patient was recovering from all events, except for ""First dose administration on 19Dec2020 and second dose administration on 12Jan2021"" with outcome of unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/01/2021,,PVT,KEFLEX [CEFALEXIN MONOHYDRATE]; CEFDINIR; ALLEGRA; ZYRTEC ALLERGY; TRIAMCINOLONE,,,,,"['Condition aggravated', 'Dyspnoea', 'Folliculitis', 'Inappropriate schedule of product administration', 'Laboratory test', 'Rash', 'Urticaria']",2,PFIZER\BIONTECH, 1037958,NC,35.0,F,"it feels like when she has an allergic reaction; nasal congestion; chest tightness; diaphoresis; This is a spontaneous report from a contactable pharmacist. A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), intramuscular on the left arm on 26Jan2021 10:15 at a single dose for COVID-19 immunization. Medical history included allergy to seafood. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular on the left arm on 04Jan2021 08:00 for COVID-19 immunization. The most recent COVID-19 vaccine was administered at the hospital. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient complained of nasal congestion, chest tightness, and diaphoresis approximately 20 mins after the second COVID vaccine on 26Jan2021 10:30. She had an allergy to seafood and stated this was what it felt like when she had an allergic reaction. The patient received one dose of Benadryl 50 mg IV, famotidine 20 mg IV, Solumedrol 125 mg IV, Zofran 4 mg IV and normal saline 500ml bolus. Patient became nauseated after receiving Benadryl and improved after receiving medications. The events were reported non-serious and required emergency room/department or urgent care. Outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported allergic reaction with symptoms of nasal congestion, chest tightness, and diaphoresis occurred approximately 20 mins after the second COVID vaccine is considered related to the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and the known safety profile of the suspect. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Seafood allergy,,,"['Chest discomfort', 'Hyperhidrosis', 'Hypersensitivity', 'Nasal congestion']",2,PFIZER\BIONTECH,OT 1037959,MI,53.0,F,"COVID 19 Vaccine being administered incorrectly; This is a spontaneous report from a contactable pharmacist. This Pharmacist reported for a 53-year-old female patient that: Contact Details Patient Details Is the patient also the reporter: No Age: 53 Years Reporter Details Reporter type: Pharmacist Primary / Prescribing Healthcare Professional Info Event Details COVID 19 Vaccine Administered incorrectly Dates of adverse event: 19Jan2021- Seriousness criteria: Medically significant Products Suspect products: COVID 19 Vaccine Therapy dates: 19Jan2021- Is this a Pfizer product: Yes NDC number: 59267-1000-01 Lot Number: EL0142 Expiry date: 01Mar2021 What was the dose, dosage units, formulation, route of administration and frequency when the adverse event occurred: Administered in left arm Sodium Chloride Therapy dates: 19Jan2021 - NDC number: 63323018604 Lot Number: 6022719 Expiry date: Sep2022 History Concomitant Products Other Products: Unknown Other conditions Other Conditions: Unknown Investigations Investigations: Unknown Additional Context The report is cross referenced to report ID: # Report 2 of 2 Caller on the line calling about the COVID 19 Vaccine. She stated she tried to place a report a couple of weeks ago regarding the vaccine potentially being administered incorrectly. She was not able to reach anyone when she contacted us previously. She reached medical information, but she is unsure if she was able to make a report. She stated she spoke to someone in medical information and was sent information about her question. She was told she would receive a fax from us requesting additional information, but she has not received it yet. She provided these details, but unsure if a report was completed. Therefore, calling to follow-up to provide details. Caller does not have a reference number to provide. Height and Weight: Unknown Ethnicity: Unknown Caller further clarified COVID 19 Vaccine being administered incorrectly as they had an immunization nurse come to the (Institute name) to help with their vaccine clinic. For some reason unknown the nurse was giving people two shots at that vaccine administration. Nurse administered one shot that was of the diluted vaccine and one was of the diluent. Caller stated she does not know why the nurse did it this way. The patient has had no side effects from this occurrence that she is aware of. Seriousness Criteria: Medically Significant. She feels this way as the patient did not get the full dose and may not fully be protected against COVID 19. Caller stated she did not directly show the immunization nurse the process of how to administer. The caller was informed by the patient that she got two shots in one setting. Caller explained the 0.3ml of the diluted vaccine was administered with a 23G needle first and then the diluent was administered as a second shot. This patient got two separate shots. Exact diluent amount administered unknown. Stated it would make since for it to be 1.8ml because that is what is remaining in the vial. Nurse was not (Institute name) trained. Caller stated the nurse questioned if patients should get two shots as this is what she had been doing. Caller stated she informed the nurse yes, as she thought she was referencing the two different doses, first vaccine and then the second vaccine three weeks later. However, nurse was giving two different shots on the same day, the diluted vaccine and the diluent. Caller clarified the diluent to be Sodium Chloride 0.9%. Vaccine Supplemental Form Patient Last Name: (Name) Patient First Name: (Name) Address: # City: # State: # Zip code: # Phone: # Patient age at time of the vaccination: 53 Years Old Time the Vaccination was Given: Around 9:30AM Vaccine Lot Number: EL0142 Vaccine Lot Expire Date: 01Mar2021 Anatomical Location of Administration of Pfizer Vaccine considered as suspect: Left arm Vaccination Facility Type- Pharmacy/Drug Store Vaccination: Facility Address: Facility Name: See reporter details Address: See reporter details City: See reporter details State: See reporter details Zip Code: See reporter details Phone: See reporter details History of all previous immunization with the Pfizer Vaccine considered as suspect: None, first dose. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None AE Details AE: COVID 19 Vaccine Administered incorrectly Time of onset: Around 9:30AM Did any of the AEs require a visit to: Emergency Room- No Physician Office- No Prior Vaccinations within 4 weeks: None Patient's Medical History: Unknown Relevant: Unknown; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Product administration error due to temporal relationship. There is very limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,01/19/2021,0.0,PHM,SODIUM CHLORIDE,,,,,['Product administration error'],2,PFIZER\BIONTECH, 1037967,OH,35.0,F,"positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable Other health care professional (patient). A 35-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 16Jan2021 at 09:00 AM (at age of 35-year-old) as a single dose for COVID-19 immunisation, lot number: unknown. Medical history was reported as none. Patient had no allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included rhamnus cathartica, rhamnus purshiana, senna spp. (HERBAL) teas, cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER), fluoxetine. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient caught covid on 30Jan2021 and she was unable to get second vaccine. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. It was also reported that since the vaccination, the patient had been tested for COVID-19. She underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab): positive on 03Feb2021. Patient was recovering from the event, at the time of the report. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/30/2021,14.0,PUB,HERBAL; APPLE CIDER; FLUOXETINE,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1037978,NY,93.0,F,"Tested positive for COVID-19 approximately 2 weeks after receiving her second dose of vaccine; Tested positive for COVID-19 approximately 2 weeks after receiving her second dose of vaccine; This is a spontaneous report from a contactable consumer. A 93-year-old female patient not pregnant received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unknown date in Jan2021 (at age of 93-year-old) as a single dose for COVID-19 immunisation, lot number: unknown. Medical history and concomitant medications were not provided. It was unknown if patient received other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient was tested positive for COVID-19 approximately two weeks after receiving her second dose of vaccine, onset date 30Jan2021. Event resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatments were administered. The patient underwent laboratory tests and procedures which included sars-cov-2 test: positive on 30Jan2021. Patient had not recovered at the time of the report. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/30/2021,29.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1037981,AZ,,F,"she was diagnosed with pneumonia; Valley fever; This is a spontaneous report from a Pfizer Sponsored Program, Pfizer First Connect. A contactable female consumer of unspecified age (patient) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, 2 days after vaccination, the patient was diagnosed with pneumonia and Valley fever. The patient was tested negative for the COVID virus on an unknown date. Her second BNT162B2 dose was scheduled for 15Feb2021. Events outcome was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Coccidioidomycosis', 'Pneumonia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1037994,,25.0,M,"they gave him 6 times the amount of the regular dosage; pharmacist made a mistake.; This is a spontaneous report from a contactable consume reported on behalf of (her fiancee). A 25-years-old male patient (medical student) received the first dose of bnt162b2 (BNT162B2, Lot Number Unknown) via an unspecified route of administration on 05Feb2021 as a Single Dose for covid-19 immunisation. The patient had no known medical history. There were no concomitant medications. Reporter does not have his vaccine card with her therefore could not provide the Lot Number or Expiration Date. On 05Feb2021, the patient experienced they gave him 6 times the amount of the regular dosage. The patient received a call from (Specialty Pharmacy name) informing him they gave him 6 times the normal dose. They said '1.8 and 0.3 was what he was supposed to get'. The patient was not given any details about how this occurred they just said the pharmacist made a mistake. The patient feels fine but customer service at (Specialty Pharmacy name) did not provide the patient with a lot of information. Consumer inquired Do they basically just monitor him? The reporter was unsure if (Specialty Pharmacy name) reported this incident to Pfizer. The clinical outcome of the event accidental overdose and product administration error was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/05/2021,0.0,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No",,,"['Accidental overdose', 'Product administration error']",1,PFIZER\BIONTECH, 1038001,CT,92.0,F,"tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable nurse reporting for the mother. A 92-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 12Jan2021 at single dose for Covid-19 immunisation . Medical history included dementia. The patient's concomitant medications were not reported. In Oct2020, the patient received the flu vaccine. The patient was tested positive for covid on 27Jan2021 with outcome of unknown. The patient was hospitalised because of the event on 29Jan2021. The patient got her first vaccine on 12Jan2021, she tested negative for COVID on 19Jan2021 but on 27Jan2021 she tested positive. The patient has been retested on 29Jan2021 and is still positive. Information of lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (tested positive for COVID after 15 days) with BNT162b2 can not be completely excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/12/2021,01/27/2021,15.0,UNK,,,Medical History/Concurrent Conditions: Dementia (she has dementia but this was prior to the vaccine.),,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1038003,FL,69.0,F,"redness; lumps on her head; swelling of the face/swelling on the side of her face; swelling of her eye; swelling of the back; rash/rash all over the body; itching; This is a spontaneous report from a contactable Physician. A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at the age of 69 years via unspecified route of administration in the right arm on 28Jan2021 13:00 (lot number EL6982 and expiry date unknown) at single dose for Covid-19 immunization in a facility. Medical history included drug allergic to penicillin, liver problems 17 or 18 years ago and has fully recovered from the liver problems. The patient was admitted to the hospital because her liver enzymes were high; ongoing high blood pressure, ongoing cholesterol (blood cholesterol abnormal), ongoing blood pressure (blood pressure abnormal). Concomitant medication included ongoing atenolol for blood pressure, ongoing lovastatin for cholesterol, ongoing losartan for high blood pressure, ongoing vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) for unspecified indication, aminobenzoic acid, biotin, choline bitartrate, folic acid, inositol, nicotinamide, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, vitamin b12 nos (B COMPLEX [AMINOBENZOIC ACID;BIOTIN;CHOLINE BITARTRATE;FOLIC ACID;INOSITOL;NICOTINAMIDE;PANTOTHENIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;VITAMIN B12 NOS]) from unspecified date for unspecified indication. The patient received first dose of BNT162B2 at the age of 69 years on 07Jan2021 13:00 (lot number EL3246) in the right arm for Covid-19 immunization and had no side effects. The patient has no prior vaccinations within 4 weeks. On 31Jan2021, the patient experienced swelling of the face, swelling of her eye, swelling of the back, rash and itching. The reporter (a retired physician/husband) was calling regarding his wife who received the second dose on 28Jan2021 and on Sunday 31Jan2021 she got swelling of the face and eyes and went to the ER for 5 or 6 hours. The patient received cortisone and Benadryl and she was some improved. Today (unspecified date) she was still getting more swelling of the face and redness. The reporter clarified that the patient received the second dose on 28Jan2021 at 13:00 in the right arm. The patient noticed 31Jan2021 in the evening swelling of her face, swelling on the side of her face, swelling of the eyes and swelling on her back, also some lumps on her head. The patient was a little improved at the ER, but today there was more rash all over the body and itching and it was getting worse. The reporter added that the rash appears on one side and then disappears and went to another part of the body. The patient underwent lab tests and procedures which included lab tests: normal on unspecified date, neck x-ray: showed no significant, it was normal except for degeneration of C5-C6 on unspecified date. The patient received treatment with the events swelling of the face/swelling on the side of her face, swelling of her eye, swelling of the back, rash/rash all over the body, itching, lumps on her head. The outcome of the events was not recovered. The events swelling of the face/swelling on the side of her face, swelling of her eye, swelling of the back, rash/rash all over the body, itching was reported medically significant.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all reported events cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/31/2021,3.0,MIL,ATENOLOL; LOVASTATIN; LOSARTAN; VITAMIN C [ASCORBIC ACID]; B COMPLEX [AMINOBENZOIC ACID;BIOTIN;CHOLINE BITARTRATE;FOLIC ACID;INOSITOL;NICOTINAMIDE;PANTOTHENIC,Blood cholesterol abnormal; Blood pressure abnormal; Blood pressure high,Medical History/Concurrent Conditions: Hepatic enzymes increased (admitted to the hospital); Hospitalization; Liver disorder (17 or 18 years ago and has fully recovered from the liver problems); Penicillin allergy,,,"['Erythema', 'Eye swelling', 'Laboratory test', 'Pruritus', 'Rash', 'Skin lesion', 'Spinal X-ray', 'Swelling', 'Swelling face']",2,PFIZER\BIONTECH, 1038005,NC,51.0,U,"extremely sick; dizziness; This is a spontaneous report from a contactable consumer (patient). A 51-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), via an unspecified route of administration on the left deltoid on 29Jan2021 at a single dose for COVID-19 immunization. Medical history included patient was asthmatic diagnosed around 8 or 9 years old. Concomitant medication included albuterol [salbutamol] for asthma. On 29Jan2021, the patient had first dose of the COVID vaccine and ended up getting extremely sick. The patient was taken by ambulance to the hospital on the same day. As reported, ""so I was in ambulance dying just put me on there, but I got 2 doses of the ""Aefrom"" and I ended up of another dose of ""hawdapil."" The patient still had a little bit of dizziness which was not bad and has improved. The doctor instructed the patient to report and find out if patient was going to be able to get the second dose because they were saying not to. The patient got the vaccine at an hospital, in a line. Outcome of the event ""extremely sick"" was unknown and of dizziness was recovering.",Not Reported,,Yes,Yes,,Not Reported,N,01/29/2021,01/29/2021,0.0,MIL,ALBUTEROL [SALBUTAMOL],,Medical History/Concurrent Conditions: Asthmatic,,,"['Dizziness', 'Malaise']",1,PFIZER\BIONTECH, 1038029,IN,55.0,F,"FAINTED; vision impairment (blackout); DIZZINESS; spinning; NAUSEA; VOMITED; over heating; chills; FATIGUE; CHILLS; over heating; A spontaneous report was received from a consumer concerning a female 55 years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fainted, vision impairment (blackout), spinning, chills, fever, fatigue, nausea, dizziness, and vomited. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Lot # 026L20A), intramuscularly (IM) (site not provided), on 05 Jan 2021. On 02-Feb-2021, the patient received their second of two planned doses of mRNA-1273 (lot #013M20A), IM (site not provided) for prophylaxis of COVID-19 infection. On 05 Jan 2021, the patient received their first Moderna vaccine. On 06 Jan 2021, patient experienced chills and overheating. On 02 Feb 2021 the patient received second dose of Moderna vaccine and experienced chills and fatigue on same day. On 03 Feb 2021, the patient experienced overheating, nausea and vomited, dizziness, spinning, vision impairment (blackout), and fainted. Treatment was not administered. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. Action taken with second dose of mRNA-1273 in response to the event was not provided The outcome of all events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested. Chills, Pyrexia, nausea, vomiting and fatigue are listed events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/06/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Chills', 'Dizziness', 'Fatigue', 'Nausea', 'Pyrexia', 'Syncope', 'Vertigo', 'Visual impairment', 'Vomiting']",2,MODERNA,OT 1038030,CA,,F,"Appendicitis; Angioedema of the face; congestion; Joint pain; Nausea; Fatigue; fever; cardiac abnormalities; ""blacked out""; Ulcers in/around the mouth; ""zaps"" all over her body and to her brain; overall body pain; Headaches; Chills; A spontaneous report was received from a healthcare professional concerning a 47-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced appendicitis, angioedema of the face, ulcer in/around the mouth, joint pain, zaps all over her body and to her brain, headaches, chills, nausea, fatigue, ""blacked out"" loss of consciousness, congestion, overall body pain, cardiac abnormalities. The patient's medical history included Covid-19. No relevant concomitant medications were reported. In March of 2020, the patient was first diagnosed with COVID-19. The patient reported she has since been considered a ""long hauler"" and has experienced various symptoms of the disease since that time. On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 ([LOT# 011J20A]) intramuscularly for prophylaxis of COVID-19 infection. After receiving the first dose of the vaccine the patient initially experienced joint pain and ""zaps"" all over her body and to her brain, headaches, chills and overall body pain. On an unspecified date, after visiting her doctor, the patient was diagnosed with angioedema of the face. Treatment medication included 2 different unspecified antihistamines. Once that condition was remedied (date unspecified), the patient still experienced fatigue, nausea and congestion. On 28 Jan 2021 the patient experienced swelling of the mouth and ulcers in and around the mouth. On 29 Jan 2021, the patient experienced severe stomach pain and cramping as well as a fever that worsened through the night. Treatment included oxycodone hydrochloride. On the morning of 29 Jan 2021, the patient was still experiencing abdominal pain and began vomiting. The pain was so much that the patient ""blacked out"" and was transported to the Emergency Room (ER). At the ER the patient experienced unspecified cardiac abnormalities. While in the ER, the patient was diagnosed with appendicitis and subsequently underwent an appendectomy. On 30 Jan 2021, the patient was discharged from the ER and was still experienced nausea, fatigue and fever. Action taken with mRNA-1273 in response to the events was not reported. The event of appendicitis was considered recovered/resolved on 30 Jan 2021, the event of angioedema and ""blacked out"" were considered recovered/resolved (dates not reported). The events of nausea, fatigue, and fever were considered not recovered/not resolved. The event outcome for ulcers in/around the mouth, joint pain, ""zaps"" all over her body and to her brain, headaches, chills, congestion, overall body pain, and cardiac abnormalities was considered unknown.; Reporter's Comments: This case concerns a 47-year-old, female subject, with medical history of COVID-19 (Mar-2020), who experienced serious events of angioedema, LOC, and appendicitis. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event of appendicitis is considered not related to the vaccine. Further information has been requested.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/26/2021,01/26/2021,0.0,UNK,,COVID-19,,,,"['Angioedema', 'Appendicitis', 'Arthralgia', 'Cardiac disorder', 'Chills', 'Fatigue', 'Headache', 'Loss of consciousness', 'Mouth ulceration', 'Nasal congestion', 'Nausea', 'Neuralgia', 'Pain', 'Pyrexia']",1,MODERNA,OT 1038032,CT,77.0,M,"Pneumonia; A spontaneous report was received from a physician concerning a 78 years-old, male patient, who received Moderna's COVID-19 Vaccine and who experienced pneumonia. The patient's medical history included chronic obstructive pulmonary disease (COPD) and pulmonary fibrosis. Products known to have been used by the patient, within two weeks prior to the event, included umeclidinium bromide/ vilanterol trifenatate, irbesartan, amlodipine besilate, metoprolol, glipizide, metformin, omeprazole, magnesium, and omega 3. The patient received their first of two planned doses of mRNA-1273 intramuscularly on 22 Jan 2021 for the prophylaxis of COVID-19 infection. On 22 Jan 2021 within a few hours of first dose, the patient developed fever, chills, weakness, and productive cough. On 24 Jan 2021, the patient was admitted to hospital due to oxygen levels in the 60s with productive cough, yellow sputum, and short of breath. He was diagnosed with pneumonia. During hospitalization, the patient had two negative PCR COVID-19 tests. Treatment information was not provided. The second dose of mRNA-1273 was discontinued in response to the events. The outcome of event pneumonia was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. Patient's medical history of COPD and pulmonary fibrosis may have been contributory.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/22/2021,01/24/2021,2.0,UNK,ANORO; AVAPRO; NORVASC; METOPROLOL; GLUCOTROL; METFORMIN; PRILOSEC [OMEPRAZOLE]; MAGNESIUM; OMEGA-3 NOS,COPD (No medical history reported.); Pulmonary fibrosis,,,,"['Oxygen saturation', 'Pneumonia', 'SARS-CoV-2 test']",1,MODERNA,OT 1038033,GA,,M,"he has eaten almost nothing; Hot to the touch (Maybe had a fever); started shaking again; has neuropathy and felt extreme pain in his feet; A little bit of delirium; Shaking violently from chills and felt very, very cold/ Could not stop the shakes; has neuropathy and felt extreme pain in his feet; Nausea; A Spontaneous report was received from a consumer concerning her husband, a 70-year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced extreme pain in his feet (increased neuropathy), a little bit of delirium, nausea, shaking violently from chills and felt very, very cold/ could not stop the shakes, hot to the touch (maybe had a fever), started shaking again, and he has eaten almost nothing. The patient's medical history included neuropathy. Concomitant medications included fish oil, blood thinner, blood pressure medication, atorvastatin, Lyrica and baby aspirin. On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 29 Jan 2021, the patient started to experience side effects: nausea, shaking from chills, felt very cold and couldn't not stop the shakes. The patient has neuropathy and felt extreme pain in his feet which continued until 01 Feb 2021, when it got somewhat better. On 02 Feb 2021, the patient was good at first but then started shaking again. During the night, the patient shook violently from chills again and he was hot to the touch (maybe he had a fever but we didn't have a thermometer). The patient also had increased neuropathy and nausea and had eaten almost nothing. He also experienced a little bit of delirium. The patient's wife gave him acetaminophen that seemed to bring down the chills. Action taken with mRNA-1273 in response to the events was not reported. The events of has neuropathy and felt extreme pain in his feet, shaking violently from chills and felt very, very cold/couldn't not stop the shakes, and started shaking again were recovering/resolving on 01 Feb 2021. The outcome of the events of a little bit of delirium, nausea, hot to touch (maybe had a fever), has neuropathy and felt extreme pain in his feet, increased neuropathy and he has eaten almost nothing was considered unknown.; Reporter's Comments: This report concerns a 70-year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced non-serious events of extreme pain in his feet (increased neuropathy), delirium, nausea, shaking violently from chills and felt very, very cold/ could not stop the shakes, fever, and he has eaten almost nothing. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,UNK,ATORVASTATIN; LYRICA; BABY ASPIRIN; FISH OIL,Neuropathy,,,,"['Chills', 'Decreased appetite', 'Delirium', 'Feeling cold', 'Nausea', 'Neuropathy peripheral', 'Pain in extremity', 'Pyrexia']",1,MODERNA, 1038034,CT,,F,"Pregnancy loss; Vaginal bleeding; Vaccine exposure during pregnancy; A spontaneous report was received from a nurse practitioner who was 31-year-old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine exposure during pregnancy, pregnancy loss (abortion spontaneous), and vaginal bleeding (vaginal hemorrhage). The patient's medical history was not provided. Concomitant medications reported as taken since conception included magnesium, prenatal vitamins, vitamin B and vitamin C. On 10 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011LZ0A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 10 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. On 02 Feb 2021, the patient developed vaginal bleeding, so she went to her obstetrician and had an ultrasound exam. The patient reported that there was no heartbeat at fifteen weeks and five days. No treatment information was provided. The patient's prior positive pregnancy test, last menstrual period, conception and due dates were not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, pregnancy loss and vaccine exposure during pregnancy, was considered resolved. The outcome of the event, vaginal bleeding, was unknown.; Reporter's Comments: This case concerns a 31 year old, female subject, who experienced a spontaneous abortion and drug exposure before pregnancy. Very limited information has been provided at this time. Further information has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/10/2021,0.0,UNK,MAGNESIUM; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; VITAMIN B [VITAMIN B NOS]; VITAMIN C [ASCORBIC ACID],,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Abortion spontaneous', 'Exposure during pregnancy', 'Ultrasound scan', 'Vaginal haemorrhage']",1,MODERNA,OT 1038035,FL,,M,"blacked out, passed out; could not move any part of the body; hard time breathing; sweating; A spontaneous report was received regarding a 73-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sweating, blacking out, passing out, inability to move any part of his body. The patient's medical history was not provided. Concomitant medications were not provided. On 01 Feb 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection. The injection took place in his car in a drive-in vaccination location. On 01 Feb 2021, approximately four minutes after the mRNA-1273 vaccine was given, the patient experienced sweating, blacking out, passing out, inability to move any part of his body. The patient reports that when he woke up he was out of his car on the grass and the emergency crew was working on him. They had given him a shot of an Epi-Pen. He had a hard time breathing and could not move any part of his body. He was placed in a wheelchair and taken into the emergency room. There, an EKG was done which had normal results. He was released from the emergency room approximately two hours later. Action taken with mRNA-1273 was not reported. The outcome of the events, sweating, blacking out, passing out, inability to move any part of his body, was considered resolved on 01 Feb 2021.; Reporter's Comments: Based on the current available information which indicates a strong temporal association between the use of the product and the onset of the reported events a causal relationship cannot be excluded",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (medical history not provided),,,"['Dyspnoea', 'Electrocardiogram', 'Hyperhidrosis', 'Hypokinesia', 'Loss of consciousness']",1,MODERNA,OT 1038036,PA,,M,"Patient with lyme disease received the second shot of the vaccine and ended at hospital; A spontaneous report was received from a consumer, concerning a male patient of unspecified age and, who received Moderna's COVID-19 vaccine (mRNA-1273) and where patient with lyme disease received the second shot of the vaccine and ended at hospital. The patient's medical history included lyme disease. Concomitant medications use was not provided On an unknown date, the patient received their second of two planned doses of mRNA-1273 (lot number: unknown) for prophylaxis of COVID-19 infection. The reporter stated that her physician advised her not to have the second shot of vaccine as on an unspecified date, other patient with lyme disease had ended up at hospital after the second shot of vaccine, Treatment of this event was not provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of event, patient with lyme disease received the second shot of the vaccine and ended at hospital was considered unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time as the reason for hospitalization is lacking. Further information has been requested",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,Lyme disease,,,,['Hospitalisation'],2,MODERNA,OT 1038037,AZ,76.0,F,"Symptoms of a bowel obstruction; Chest burning; Vomiting sensation; A spontaneous report was received from a consumer, concerning herself, a 76-years-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced symptoms of a bowel obstruction, burning sensation in chest and vomiting sensation. The patient's medical history was not provided. Concomitant medications reported included telmisartan, nebivolol hydrochloride, ezetimibe, valaciclovir, buspirone and alprazolam. On 21 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 [lot number 011L20A] intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2021, following the administration of vaccine, the patient experienced a burning sensation in the chest, vomiting sensation and symptoms of a bowel obstruction. These side effects were worsened until the patient was admitted for bowel obstruction relief. Additionally, event symptoms of a bowel obstruction was considered life threatening. Treatment for the event included bowel obstruction removal. No side effects were existing at the time of this report. The second dose of mRNA-1273 was delayed in response to the events. The outcome of the events symptoms of a bowel obstruction, burning sensation in chest and vomiting sensation were considered resolved on an unspecified date in 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Yes,Yes,,Not Reported,Y,01/21/2021,01/21/2021,0.0,UNK,TELMISARTAN; BYSTOLIC; ZETIA; VALACICLOVIR; BUSPIRONE; ALPRAZOLAM,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Chest pain', 'Intestinal obstruction', 'Nausea']",1,MODERNA,OT 1038042,OH,53.0,F,"Patient expired 02/06/2021. COD as ruled by Coroner ""Hypertensive and Atherosclerotic Cardiovascular Disease.""",Yes,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,PUB,,,,,,"['Arteriosclerosis', 'Death', 'Hypertension']",UNK,PFIZER\BIONTECH,IM 1038079,,,F,"Passed Out; flushed; sleeping all day; kind of like a fever; nauseated; Headache; A spontaneous report was received from a healthcare professional (HCP) concerning a 72-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passing out (loss of consciousness), flushed, sleeping all day, kind of like a fever, nausea and headache. The patient's medical history was not reported. Concomitant products known to have been used by the patient, within two weeks prior to the event, included pantoprazole. On 02 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 007M204) for prophylaxis of COVID-19 infection. The patient stated that on 04 Feb 2021, the patient got up in the morning and didn't feel very well. She stated that she was flushed, had a headache and a fever. She had a coffee and sandwich and talked to her husband and then they got up and passed out. They slept all day and did not feel well. The patient stated that she was nauseated and felt like she had a fever and a real, dull headache. Treatments for these events were not reported. Action taken with mRNA-1273 in response to this event was not reported. The outcome for the events passing out (loss of consciousness), flushed, sleeping all day, kind of like a fever, nausea and headache was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,01/04/2021,,UNK,PANTOPRAZOLE 40,,Medical History/Concurrent Conditions: No adverse event (No adverse event history),,,"['Flushing', 'Headache', 'Loss of consciousness', 'Nausea', 'Pyrexia', 'Somnolence']",1,MODERNA, 1038080,CA,,M,"Bells Palsy symptoms; A spontaneous report was received from a consumer who was also a 65-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's palsy symptoms/ facial paralysis. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included duloxetine hydrochloride. On 29 Jan 2021, approximately seven days prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot# 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 04 Feb 2021, the patient went to the dentist and started to develop Bell's palsy symptoms afterwards. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, Bell's palsy symptoms, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. However, patient's unspecified dental procedure may have been contributory.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,02/04/2021,6.0,UNK,CYMBALTA,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Facial paralysis'],1,MODERNA,OT 1038114,FL,47.0,F,"Prior to getting my vaccine I decided to pre-medicate about 30 minutes' prior with 50mg of Benadryl. I received my second Covid Vaccine on Thursday 2/4/21. After waiting about 25 minutes, I started to have tightness in my chest and coughing. I notified staff. They took me back to the observation room with a nurse. At about 28 minutes, voice changed very raspy, chest tightness worse, I could not stop coughing and a very mottled rash on the arm of injection. I was kind of out of it, like wanted to answer questions but really had to think about what I was trying to say and hard to find the answers. They immediately took me to the ER where the doctor ordered and nurse administered Epinephrine....cont",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,WRK,"Valtrex 500mg QD (Herpes in Right Eye), Sertraline 50mg QD,",Covid Virus dx 1/14/21,"Allergies, Asthma, questionable MS.??",TB skin test--local reaction after approximately 4 days. Allergy Shots-anaphylaxis,"Sulfa, Melon, Asparagus, Pineapple, Mint, Many enviornmental","['Back pain', 'Chest discomfort', 'Communication disorder', 'Condition aggravated', 'Confusional state', 'Cough', 'Dysphonia', 'Feeling abnormal', 'Headache', 'Injection site pain', 'Injection site rash', 'Livedo reticularis', 'Neck pain', 'Pain']",2,MODERNA,IM 1038117,KY,85.0,F,"Moderna COVID-19 Vaccine given at local health department on 2/1/21. Patient developed nausea and loss of appetite post vaccine. Became weak and sought care at ED on 2/5/21. Found to have leukopenia, anemia. Hydrated and discharged home. Patient continued to feel unwell, developed vomiting and diarrhea (has chronic diarrhea since partial colectomy for remote colon CA, but symptoms were worse). Sought care at my health center on 2/9/21. In-house CBC revealed pancytopenia and patient was clinically ill-appearing and severely dehydrated. Patient was sent back to ED for further evaluation. Patient admitted and consults made to Hematology and GI. Stool culture and cdiff negative, Patient was hydrated and had electrolytes replaced. Acute renal failure present on admission resolved with IVF. Sepsis was ruled out. Developed epistaxis requiring 1 unit of platelets to which she had a moderate allergic reaction requiring steroids and benadryl. Severe thrombocytopenia treated with Peg Filgrastim. CBC improved and patient was discharged to follow up with heme/onc. Her methotrexate and eliquis was held.",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,02/01/2021,02/03/2021,2.0,PUB,"fosamax 70mg weekly, norvasc 5mg daily, allopurinol 100mg daily, centrum silver one daily, diovan hct 320/12.5 one daily, eliquis 5mg BID, otc fiber tabs prn, otc fish oil, flonase nasal spray, folic acid 1mg one daily, methotrexate 2.5mg 5",None,"Rheumatoid Arthritis, Polymyalgia Rheumatica, HTN, Chronic Kidney Disease Stage 2 with anemia of chronic disease, macrocytic anemia due to methotrexate, allergic rhinitis, gout, sarcoidosis, paroxysmal atrial fibrillation, remote history of rectal carcinoma s/p chemo/RT and low anterior resection 2011",,Sulfa,"['Activated partial thromboplastin time normal', 'Acute kidney injury', 'Anaemia', 'Aspartate aminotransferase increased', 'Asthenia', 'Blood creatinine increased', 'Blood culture negative', 'Blood glucose increased', 'Blood magnesium normal', 'Blood phosphorus decreased', 'Blood potassium decreased', 'Blood thyroid stimulating hormone normal', 'Blood urea increased', 'Culture stool negative', 'Culture urine negative', 'Decreased appetite', 'Dehydration', 'Diarrhoea', 'Epistaxis', 'Haemoglobin decreased', 'Illness', 'International normalised ratio normal', 'Leukopenia', 'Malaise', 'Mean cell volume increased', 'Metabolic function test', 'Nausea', 'Neutrophil count decreased', 'Pancytopenia', 'Platelet count decreased', 'Protein total normal', 'Thrombocytopenia', 'Urinary system X-ray', 'Vomiting', 'White blood cell count decreased']",UNK,MODERNA,IM 1038143,KS,37.0,F,"STEMI, chest pain started around 8 PM the day of receiving 2nd dose of COVID 19 vaccine. COVID 19 vaccine received at 11 AM. Patient presented to ED 2/17/21 AM with chest pain, ECG reveled ST elevation, proceeded to PCI",Not Reported,,Yes,Yes,2.0,Not Reported,Y,02/16/2021,02/16/2021,0.0,WRK,"albuterol prn, adderall, benzonatat, tums prn, ibuprofen prn, melatonin, multivitamin, pantoprazole",,"asthma, obesity, add",Patient describes chest pain after 1st dose of COVID vaccine that later resolved after emesis X3.,NKDA,"['Acute myocardial infarction', 'Chest pain', 'Electrocardiogram ST segment elevation', 'Electrocardiogram abnormal', 'Percutaneous coronary intervention']",2,PFIZER\BIONTECH,IM 1038146,PA,66.0,F,TIA experienced on 2/13/2021 upon rising from sleep/found lacuner infarct on MRI in ER on 2/13/21,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/06/2021,02/13/2021,7.0,PVT,"Vitamin D, Vitamin C, Calcium, Tumeric, Glucosamine",None,None,,None,"['Arteriogram carotid', 'Cardiac monitoring', 'Computerised tomogram head', 'Electrocardiogram', 'Laboratory test', 'Lacunar infarction', 'Magnetic resonance imaging abnormal', 'Magnetic resonance imaging brain', 'Scan with contrast', 'Transient ischaemic attack', 'Troponin']",2,MODERNA,IM 1038147,TN,86.0,F,"Patient went into new-onset atrial fibrillation, resulting in a catastrophic stroke. Patient passed away on 2/11 as a result of the stroke.",Yes,02/11/2021,Not Reported,Yes,10.0,Not Reported,N,01/28/2021,01/30/2021,2.0,PVT,"Amlodipine, propranolol, levothyroxine",None,"Hypertension, hypothyroidism",,Sulfa drugs,"['Atrial fibrillation', 'Cerebrovascular accident', 'Death', 'Intensive care']",1,MODERNA,IM 1038149,SC,72.0,M,"Received dose 1 on 1/27/2021. On 2/7/21, patient experienced RLE weakness, gait imbalance, and leaning to the right side. CT showed no acute intracranial hemorrhage however MRI of brain demonstrated acute infarction of the posterior limb of the left internal capsule. Patient was admitted to inpatient acute rehab due to issues with self-care, safety awareness and ambulation.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/27/2021,02/07/2021,11.0,UNK,,,"CAD, h/o renal transplant, HTN",,NKDA,"['Computerised tomogram head', 'Gait disturbance', 'Internal capsule infarction', 'Magnetic resonance imaging brain abnormal', 'Muscular weakness', 'Posture abnormal']",1,PFIZER\BIONTECH,IM 1038179,NY,78.0,F,"ON 2/14/21 PATIENT WAS FOUND BY FAMILY CONFUSED, DIAPHORETIC, VOMITING, TAKEN TO E.D, CT SCAN REVEALED A SUBARACHNOID HEMORRHAGE, PT INTUBATED IN ICU PER DAUGHTER FOUND have 2 ANEURYSMS.",Not Reported,,Yes,Yes,,Not Reported,U,01/19/2021,02/14/2021,26.0,OTH,"ASA 81 mg, lipitor,cipro, metformin, ultram,amaryl, victoza, WELLBUTRIN","celluitis L foot, diabetic ulcer","poorly controlled diabetes, HTN,carotid artery stenosis, neuropathy",,Penicillin,"['Activated partial thromboplastin time normal', 'Aneurysm', 'Blood creatinine normal', 'Computerised tomogram abnormal', 'Confusional state', 'Endotracheal intubation', 'Glomerular filtration rate decreased', 'Hyperhidrosis', 'Intensive care', 'International normalised ratio decreased', 'Platelet count normal', 'Subarachnoid haemorrhage', 'Vomiting']",1,MODERNA,IM 1038191,MD,74.0,F,"Moderna vaccine # 1 caused left arm pain, difficulty moving the arm, unable to drive for 3 days, disabling. LIke a frozen shoulder. Patient recovering partially by day 4. Advised ice, pain meds and mobilizing shoulder",Not Reported,,Not Reported,Not Reported,,Yes,N,02/15/2021,02/15/2021,0.0,PHM,"rosuvastatin, muro eyedrops, lisinopril, omeprazole and vitamin D",None,"Hypertension, hyperlipidemia, dry eyes, and reflux","arm pain with pneumovax and shingrix, not given by me",PCN caused rash,"['Disability', 'Impaired driving ability', 'Injected limb mobility decreased', 'Injection site pain', 'Pain in extremity', 'Periarthritis']",1,MODERNA,IM 1038209,CT,70.0,M,"when i first got the shot i could feel a difference in my body immediately. i started hurt on my left side of my throat, then started getting puffy face and eyes. was given some Benadryl pulse 45 blood pressure 90/54 and did an EKG , then medic didn't like what he was seeing and called 911 . Medic gave him an epi pen because his throat started swelling. Went to the hospital where he was there for 5 hrs.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/16/2021,02/16/2021,0.0,UNK,,,high blood pressure,,"Penicillin, bananas","['Blood test', 'Electrocardiogram', 'Oropharyngeal pain', 'Periorbital swelling', 'Pharyngeal swelling', 'Swelling face']",1,MODERNA,IM 1038225,AK,83.0,M,"Death, 2-17-21 at 1802 hours",Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,N,01/11/2021,02/17/2021,37.0,SEN,"Metoprolol, Pramipexole, Furosemide, Aspirin, Haloperidol, Lorazepam, Morphine","G60.9, D72.1,","G60.9, D72.1,",,"Tomato, cheese",['Death'],2,PFIZER\BIONTECH,IM 1038228,FL,38.0,F,"3 days after the second Moderna vaccine patient developed right arm and leg weakness, tingling over the whole body",Not Reported,,Not Reported,Yes,,Not Reported,N,02/08/2021,02/11/2021,3.0,OTH,,None,Migraine,,Levaquin,"['Intervertebral disc disorder', 'Magnetic resonance imaging brain abnormal', 'Magnetic resonance imaging spinal abnormal', 'Muscular weakness', 'Paraesthesia', 'White matter lesion']",2,MODERNA, 1038234,MA,84.0,F,"First dose Pfizer given at assisted living on 1/14/21 she was subsequently admitted to hospital and got her second dose but Moderna was given instead of Pfizer on 2/8/21. She had been improving but in the days following the Moderna vaccine she developed fever and then her mental status declined. She was discharged back to assisted living. Suspected UTI, and moderate dementia, placed on hospice (2/12/21). Died on 2/13/21.",Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,,,SEN,"Cephalexin Spiriva, Nitro, Probiotic, Albuterol, Vitamin D3, Multivitamin Aspirin, Glucosamine, Metamucil, Tylenol, Cranberry, Claritin, Quetiapine",Dementia with mental status change Urinary tract infection,"Dementia Hypertension, Chronic UTI Hyperlipidemia, h/o Alcohol Abuse in Remission",,"Sulfa, Aricept","['Condition aggravated', 'Death', 'Dementia', 'Mental impairment', 'Pyrexia', 'Urinary tract infection', 'Wrong product administered']",1,PFIZER\BIONTECH,IM 1038249,KY,,F,"Moderate allergic reaction; Felt light headed and dizzy; Cough; dry throat; Scratchy throat; Nose Tingling; did not sleep well; O2 saturation levels fluctuating from 97-86; A spontaneous report was received from nurse concerning a 56-year-old female patient who felt lightheaded and dizzy and experienced moderate allergic reaction, cough, nose tingling, dry and scratchy throat, unwell sleep, and oxygen saturation fluctuations. The patient has past medical history of Chronic obstructive pulmonary disease (COPD) and emphysema. No relevant concomitant medications were reported. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273, for prophylaxis of COVID-19 infection. On 29 Dec 2020, immediately after the vaccine shot, she felt lightheaded and dizzy. She experienced nose tingling, cough and her throat was dry and scratchy. Her symptoms were considered severe by clinic staff and the patient was taken to the emergency Room (ER). Her oxygen levels were reported to be fluctuating from 97-86. The reaction was considered a moderate allergic reaction. Treatment with diphenhydramine and steroid shot was given. The patient condition improved and was discharged from the ER with prescription for steroid taper. The patient did not sleep well and did not contact the provider about any symptoms. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events, moderate allergic reaction, felt lightheaded and dizzy, cough, nose tingling, dry and scratchy throat, unwell sleep, and oxygen saturation fluctuation was unknown. The causality assessment for the events, moderate allergic reaction, felt lightheaded and dizzy, cough, nose tingling, dry and scratchy throat, unwell sleep, and oxygen saturation fluctuation was not provided.; Reporter's Comments: This case concerns a 56-year-old female patient with a relevant medical history of COPD and emphysema who received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient experienced the serious unlisted event of Hypersensitivity, and non--serious unlisted event of Dizziness, Cough, Dry throat, Throat irritation, Poor quality sleep, and Oxygen saturation decreased. The events occurred on the same day after first dose of mRNA-1273, lot # unknown. Treatment for the events included diphenhydramine and steroid shot. Based on the temporal association between the use of the product and the events occurring after receiving the vaccine, a causal relationship cannot be excluded and the events are considered possibly related to the product.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,UNK,,,Medical History/Concurrent Conditions: COPD; Emphysema,,,"['Cough', 'Dizziness', 'Dry throat', 'Hypersensitivity', 'Oxygen saturation', 'Oxygen saturation abnormal', 'Paraesthesia', 'Poor quality sleep', 'Throat irritation']",1,MODERNA,OT 1038250,NY,73.0,F,"Sadle embolism in lungs; DVT in left leg; Slight fever; Extreme fatigue; Shortness of breath,struggling for every breath; Low o2 sat; A spontaneous report was received from a health care professional, who was a 73-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced shortness of breath, slight fever, extreme fatigue, left leg deep vein thrombosis (DVT), and saddle pulmonary embolism (PE). The patients' medical history was not provided. No concomitant medications list was provided. On 24 Dec 2020, prior to the onset of symptoms, patient received the first of two planned doses of mRNA-1273 (Batch number 011J20A) for the prophylaxis of COVID -19 infection. On 25 Dec 2020, patient experienced shortness of breath with low oxygen saturation levels. On 26 Dec 2020, the patient's oxygen saturation levels were down to 89% with slight fever and extreme fatigue. On 27 Dec 2020, patient's energy was back to normal. On 28 Dec 2020, the patient woke up in the morning with symptoms of almost could not breathe, could not walk across the room. The patient's vital signs included oxygen saturation 83%. The patient was struggling for every breath. The patient tested negative for COVID-19. On 30 Dec 2020, another COVID-19 test was negative. On 31 Dec 2020, patient's vital signs included oxygen saturation closer to 90%, and she reported getting better. Symptoms remained the same for about a week. On 08 Jan 2021, the patient experienced left ankle and foot swollen. The patient was seen by physician and then sent to emergency room where it was determined that the patient had DVT in the left leg. A computerized tomogram (CT) scan found clots in the left lung, or saddle PE. On 09 Jan 2021, the patient was discharged from the hospital. Treatment for the events experienced included intravenous heparin and blood thinners. Action taken with planned second dose of mRNA-1273 in response to the events was not provided. The event, extreme fatigue, was considered resolved on 27 Dec 2020. The outcome of the events, shortness of breath, slight fever, DVT and saddle PE were not provided. Follow-up received on 19 Jan 2021 included updated events (DVT and saddle PE), updated event details, treatment, and hospitalization details.; Reporter's Comments: This spontaneous report refers to a case of 73- year-old female patient who experienced serious event of pulmonary embolism and deep vein thrombosis and non-serious events of shortness of breath, oxygen saturation levels were down to 89% with slight fever and extreme fatigue the next day after administration of the first dose of mRNA-1273, lot # 011J20A, expiration date-unknown. Based on temporal information provided and the known safety profile of the vaccine and the absence of any other etiology factors, a causal association between the vents of shortness of breath, oxygen saturation levels were down to 89% with slight fever and extreme fatigue and the administration of mRNA-1273 vaccine cannot be excluded. Fever and fatigue are consistent with the known safety profile of mRNA-1273 vaccine. There is no enough information t clinically assess the causal association between the events of pulmonary embolism and deep vein thrombosis as the patient's medical history and list of concomitant medications were lacking. Main field defaults to �possibly related'",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,12/24/2020,12/25/2020,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Computerised tomogram', 'Deep vein thrombosis', 'Dyspnoea', 'Fatigue', 'Oxygen saturation', 'Oxygen saturation decreased', 'Pulmonary embolism', 'Pyrexia', 'SARS-CoV-2 test']",1,MODERNA,OT 1038251,NC,63.0,F,"Hyperpigmentation; Sloughed skin; Bullous eruption eventually peeled off with ""sloughed skin""; Redness down to side of the arm and demarcation, looks like a burn; Constant burning sensation; Bullous eruption on her arm; Bruising; Discoloration; Blisters; Vesicular pustules; Significant pruritus; Arm felt warm; Significant tenderness and pain on arm/significant tenderness and pain; Her arm felt warm, painful and was red; Swelling extended down to her arm; A spontaneous report was received from a physician, who was also a 63-year old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, bullous eruption on her arm, bruising, discoloration, blisters, vesicular pustules, significant pruritus, hyperpigmentation, constant burning sensation, sloughed skin, arm felt warm, bullous eruption eventually peeled off with ""sloughed skin,"" redness down to side of the arm and demarcation, looks like a burn, significant tenderness and pain on arm/significant tenderness and pain, her arm felt warm, painful and was red, and swelling extended down to her arm. The patient's medical history, as provided by the reporter, included hypertension, sulfonamide drug allergy, and penicillin drug allergy. Concomitant medications reported included bisoprolol, telmisartan, vitamin D, vitamin C, and zinc. On 30 Dec 2020, approximately four hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection. On 30 Dec 2020, after receiving the vaccine, the patient experienced warmth, redness, and pain in the arm which she treated with ice and diphenhydramine. On 31st Dec 2020, 14 hours after vaccine administration, the patient started to experience bullous eruption on her arm, pruritis and constant burning sensation in the arm. She reported having swelling extended down to her arm, bruising, discoloration, blisters, small vesicular pustules, erythema down to the side of the arm, and demarcation. She spoke to her primary care provider as her rash continued to evolve. She was started on a methylprednisolone pack but only took two doses for concern it would blunt the immune response to the vaccine. Additionally, she was treated with triamcinolone ointment. On 03 Jan 2021, the bullous eruptions peeled off with sloughed skin, she had an excoriated area underneath the skin. She also had tenderness and pain in the arm which resolved spontaneously. The patient self-treated the events with benzethonium chloride and vitamin E oil. On 28th Jan 2021, the patient had hyperpigmentation of her posterior arm with an excoriated area. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, bullous eruption on her arm, bruising, discoloration, blisters, vesicular pustules, significant pruritus, hyperpigmentation, constant burning sensation, arm felt warm, bullous eruption eventually peeled off with ""sloughed skin"", redness down to side of the arm and demarcation, looks like a burn, her arm felt warm, painful and was red, and swelling extended down to her arm, was not reported. The outcome of the event, sloughed skin, was considered recovering. The outcome of the events, significant tenderness and pain on arm/significant tenderness and pain and swelling extended down to her arm, was considered resolved.; Reporter's Comments: This case concerns a 63 year old female patient with medical history of hypertension, sulfonamide drug allergy, and penicillin drug allergy, who experienced a serious unexpected event of Dermatitis bullous and NS unexpected events of bruising, discoloration, blisters, vesicular pustules, significant pruritus, hyperpigmentation, constant burning sensation, sloughed skin and arm felt warm. The events occurred 14 hours after first dose of the study medication administration. She was started with a methylprednisolone pack and triamcinolone ointment. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,BISPROLOL COMP; TELMISARTAN; VITAMIN D 2000; VITAMIN C;VITAMIN D NOS;VITAMIN E; ZINC,,Medical History/Concurrent Conditions: Drug allergy (Allergy to sulfa medications as a child.); Hypertension; Penicillin allergy (As a child),,,"['Blister', 'Burning sensation', 'Contusion', 'Dermatitis bullous', 'Erythema', 'Injection site erosion', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Pruritus', 'Rash pustular', 'Skin discolouration', 'Skin exfoliation', 'Skin hyperpigmentation', 'Swelling']",1,MODERNA,OT 1038252,IN,,F,"Nervous system disorder NOS; Severe uncontrollable body movements, my tongue was also affected; Allegedly having an adverse reaction with seizures; A spontaneous report was received from a consumer who was a 42-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced attack on nervous system, severe uncontrollable body movements, and allegedly having an adverse reaction with seizures. The patient's medical history, as provided by the reporter, included hysterectomy. No concomitant medications were provided. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 011L20A) for prophylaxis of COVID-19 infection. On 07 Jan 2021, the patient's tongue began to spasm. On 08 Jan 2021, the patient's whole body had been convulsing all day. The patient reported that it was attacking her nervous system on an undisclosed date. She visited four hospitals in two days; all blood work was normal. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, attack on nervous system, severe uncontrollable body movements, and allegedly having an adverse reaction with seizures, was considered not recovered/not resolved.; Reporter's Comments: This case concerns a 42-year-old, female patient with medical history of hysterectomy, who experienced serious, unexpected event of seizures and non-serious, unexpected event of dyskinesia and nervous system disorder NOS. The events occurred 4 days after the first dose of mRNA-1273 (Lot Number: 011L20A) administration. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/07/2021,3.0,UNK,,,Medical History/Concurrent Conditions: Hysterectomy,,,"['Dyskinesia', 'Nervous system disorder', 'Seizure']",1,MODERNA,OT 1038253,FL,,M,"Died the next day; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and died the next day. The patient's medical history was not provided. Concomitant medication use was not provided by the reporter. On 12 Jan 2021, approximately one day prior to the event, the patient received one of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 13 Jan 2021 the patient died. No additional information was provided in regards to the event. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on 13 Jan 2021. The cause of death was unknown.; Reporter's Comments: This case concerns a male patient of unknown age. The medical history and concomitant medication were not provided. The patient died approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death",Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Death'],1,MODERNA,OT 1038254,,,M,"Heart rate 145 beats per min; Shortness of breath; Panic attack; Severe dehydration; Cannot quench thirst; Numb tongue and mouth; Fever of 104 F; Aches; Chills; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced heart rate 145 beats per min (bpm), fever of 104F, shortness of breath, panic attack, severe dehydration, cannot quench his thirst, numb tongue, numb mouth, aches and chills. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced a fever of 104 F, elevated heart rate of 145 bpm, severe dehydration, cannot quench his thirst, numb tongue and moth for 3 days and aches and chills for 3 days. He sought medical attention at his doctor's office. A urinalysis was completed which resulted normal. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The events, heart rate 145 beats per min, fever of 104F, shortness of breath, panic attack, severe dehydration, cannot quench his thirst, numb tongue, numb mouth, aches and chills, were considered resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Body temperature', 'Chills', 'Dehydration', 'Dyspnoea', 'Heart rate', 'Hypoaesthesia oral', 'Pain', 'Panic attack', 'Pyrexia', 'Tachycardia', 'Thirst', 'Urine analysis']",1,MODERNA,OT 1038255,NY,78.0,F,"Viral encephalitis; Short term memory loss; Combative behavior; Significant cognitive deficit; Not remembering words; Completely incoherent; A spontaneous report was received from a consumer concerning a 78-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced short term memory loss, combative behavior, viral encephalitis, significant cognitive deficit, not remembering words, and completely incoherent. The patient's medical history, as provided by the reporter, included an unspecified thyroid disorder. Concomitant medications reported included levothyroxine and levothyroxine sodium. On 09 Jan 2021, approximately two days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient began exhibiting short term memory loss and combative behavior. She was completely incoherent, not remembering words, could not name colors or shapes, and her short term memory was gone. On 15 Jan 2021, the patient saw a neurologist and tests ordered included a doppler and air being blown into her ear. On 18 Jan 2021, the patient had unspecified bloodwork done. No results were provided. On 21 Jan 2021, three magnetic resonance imaging (MRI) exams were conducted as well. No results were reported. On 21 Jan 2021, it was reported the patient's symptoms had not resolved and the patient had since been hospitalized. Her doctors believed she developed viral encephalitis brought on by the COVID vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The events, short term memory loss, combative behavior, viral encephalitis, significant cognitive deficit, not remembering words, and completely incoherent, were considered not resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/09/2021,01/11/2021,2.0,UNK,LEVOTHYROXINE; LEVOXINE [LEVOTHYROXINE SODIUM],Thyroid disorder NOS,,,,"['Aggression', 'Amnesia', 'Aphasia', 'Cognitive disorder', 'Encephalitis viral', 'Incoherent']",1,MODERNA,OT 1038257,NM,63.0,M,"Passed away; tired; nonresponsive; cold; difficulty breathing; swelling; sore arm; feeling weird and funny; A spontaneous report (United States) was received from a consumer concerning a 63 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient experienced limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal and the patient passed away . Medical history included treatment for tuberculosis and dialysis. Concomitant medication included calcium acetate, Renvela, glipizide, omeprazole, aspirin, vitamin D, losartan, furosemide, rifampin, and Sensipar. On 14 Jan 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 030L20A) for prophylaxis of COVID-19 infection. On 13 Jan2021, the patient tested negative for COVID-19). On 16 Jan 2021, the patient experienced a sore arm, and feeling weird/funny. On 17Jan2021, the patient experienced difficulty breathing and swelling. On 18 Jan 2021, the patient declined dialysis, was tired and wanted to lay down. At 8 am, the patient was found nonresponsive and cold and is believed to have passed away around 4 am. The coroner tested the deceased for COVID-19 and the test was positive. No autopsy was reported. No death certificate was issued at the time of the report but the reporter believes it will list cause of death as COVID complications. Action taken with the mRNA-1273 was not applicable. The outcome of the events of limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal, was fatal. On 18 Jan 2021, the patient was died. Cause of death was COVID-19. Autopsy details were not provided.; Reporter's Comments: The events developed on four days after first dose of mRNA-1372. Dyspnea, unresponsive to stimuli, and death were consistent with infection in pandemic set up confounded by age of patient and refusal of dialysis Cause of death was reported as COVID-19. Autopsy details were not provided. Based on reporter's causality the events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: COVID-19",Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/16/2021,2.0,UNK,CALCIUM ACETATE; RENVELA; GLIPIZIDE; OMEPRAZOLE; ASPIRIN (E.C.); VITAMIN D NOS; LOSARTAN; FUROSEMIDE; RIFAMPIN; SENSIPAR,Dialysis; TB,,,,"['Body temperature abnormal', 'Death', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Limb discomfort', 'SARS-CoV-2 test', 'Swelling', 'Unresponsive to stimuli']",1,MODERNA,OT 1038258,NC,,F,"Woke up on the floor, not sure if passed out or was unconscious; Cramps in hand; Hands shook; Dry heaving; Voice kind of changed; Urine was very bright; Chills; A spontaneous report was received from a female (age unknown) consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cramps in hand, hands shook/shaking of hands, dry heaving/dry heaves, voice kind of changed/distorted voice, urine was very bright/urine color abnormal, chills and woke up on the floor, not sure if passed out or unconscious. The patient's medical history was not reported. No relevant concomitant medications were reported. On 28 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On unknown date, patient started to experience cramps in hand, shaking of hands, dry heaving, voice kind of changed, urine was very bright, chills and woke up on the floor, not sure if passed out or unconscious. Treatment for the events were not provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, cramps in hand, hands shook/shaking of hands, dry heaving/dry heaves, voice kind of changed/distorted voice, urine was very bright/urine color abnormal, chills and woke up on the floor, not sure if passed out or unconscious was Unknown.; Reporter's Comments: The events developed after first dose of mRNA-1372. Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Chills', 'Chromaturia', 'Dysphonia', 'Muscle spasms', 'Retching', 'Syncope', 'Tremor']",1,MODERNA,OT 1038259,FL,88.0,M,"pneumonia (felt cold, fever, difficulty breathing, body aches); A spontaneous report was received from a healthcare professional concerning an 88-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia. Medical history included atrial fibrillation. No relevant concomitant medication was reported. On an unspecified date, the patient received a dose of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced being cold at night, felt fever in the morning, had difficulty breathing, body aches, and was diagnosed with pneumonia at the hospital. The patient was treated while in the hospital (treatment was unknown). Action taken with the mRNA-1273 in response to the event was not reported. The event, pneumonia, was considered resolved.",Not Reported,,Not Reported,Yes,,Not Reported,Y,,,,UNK,,AFib,,,,['Pneumonia'],1,MODERNA,OT 1038290,IL,68.0,M,Death on same day as vaccination,Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/03/2021,0.0,OTH,Amlodipine-benazapril; atorvastatin; basaglar Kwikpen; citalopram; clopidrogel; coreg; fenofibrate; glipizide; hydrochlorothiazide; metformin; pantoprazole; ropinirole,"Outpatient admission 1/25-1/27 with Hypertension urgency and inability to care for self at home, discharged to Agency; 1/28/21 had a choking episode and continued to decline from there. ER 1/31 and 2/1 for low grade fever and continued decline returned to SNF and wife placed patient on hospice.",Apnea; diabetes; dyslipidemia; ischemic stroke; prostate disorder; multiple CVAs with residual weakness,,Sulfa,"['Blood creatinine increased', 'Blood urea increased', 'Death', 'Glomerular filtration rate', 'Lymphocyte percentage decreased', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1038302,NY,87.0,F,"morning after the vaccine my mother couldn't walk and fell out of bed, released her bowels, was nauseous and weak. Called EMT and was taken to hospital. Her blood count dropped to 8.0, dehydrated and remains weak. I am awaiting more information from the hospital on her condition.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/16/2021,02/17/2021,1.0,PHM,"Junuvia, metoprolol, metformin, Furosemide, tylenol, losartan",,"anemia, diabetes, heart disease",,no,"['Asthenia', 'Blood test', 'Chest X-ray', 'Dehydration', 'Fall', 'Gait inability', 'Nausea']",1,MODERNA,IM 1038305,TX,50.0,M,"On January 21, 2021 I started feeling pains in my right shoulder (1st shot was left shoulder) and the following day it had spread across my body, shoulders, chest, arms, legs and calves. I also had a severe headache along with the muscle pains and woke up each day since in a pool of sweat with the sheet soaked to this day. Due to the severe muscle pains, I started taking Tylenol and all the symptoms pointed to the virus itself. I was tested for the virus on Monday, January 25th with negative results on the morning of the 26th. I continued to self-medicate with Advil every four hours to remove the severe muscle pains noted above. To back track slightly, I had a colonoscopy on January 19, 2021 and one large polyp was removed without issue. Due to the full body muscles pains and taking the Advil, it likely caused bleeding from the polyp site of the colonoscopy and went to the ER and they transferred me back the hospital on January 28, 2021, the location of the colonoscopy, and hospital found nothing wrong with the colonoscopy during my 2.5 day stay there. The did an x-ray of my chest to test for the flu and related items and found everything to be clear. They also a CT of my abdomen to look for any abnormalities and found none. Through all this the muscle pains continued when I would move, the muscles would fire up and intense pain persisted until I could calm them down after about 30 mins of intense pain. Hospital also tested me twice for the COVID virus and each turned out negative. Overall, I?ve been tested for the virus nearly 12 times and all were negative. From the visit to Hospital, with the colonoscopy and no additional bleeding occurring, Hospital gave me a steroid called Prednisone to mask the pain on Saturday, January 30, 2021 at about 1pm and by 4pm they fully released me with no idea what was causing the severe muscle pain across my body when I moved. I literally just walked out of the hospital since the steroid masked the muscle pain issue. The steroids worked but I was still walking up in a pool of sweat and very clammy and wet each morning from 1am until I woke up. On February 2, 2021 I had 3 bowel movements that were all dark purple and full of blood clots which led me back to Hospital and the ER could not get in touch with the Hospital Doctors for transfer so they admitted me to the Hospital, thank God. On February 4, 2021 Methodist performed an emergency colonoscopy to clamp the polyp site, took two additional polyps out and did an endoscopy to ensure my upper and lower GI track were clear, and it was and the two additional polyps were benign. Through all this the serve muscle pains persisted and Hospital moved me to a patient room and out of the ER. Over the next several days, February 4 thru the 11th Hospital cleared me of everything they could test for, over 85 different tests were ran based on MyChart. All my blood counts were all over the place, WBC were 19,000, Platelets were nearly 700, my sedimentation rate reached 64+ and the server muscle pains persisted and I was basically incapacitated during my entire stay at Hospital. Hospital had several specialists seem me from Internal Medicine, Infectious Disease, Neurology to Rheumatoid ologist and none of them found anything wrong with me other than my COVID anti-bodies were enormously high with not signs of slowing down. The conclusion by each of the specialist is that my symptoms all point to an Adverse Level 3 Inflammatory Reaction to the first COVID Vaccine shot. The Infectious Disease specialists emphasized that I DO NOT get the second vaccine shot since it would like have killed me. (We had cancelled my 2nd shot, scheduled for February 3, 2021 via Cancer Center the week of January 30, 2021.) Hospital concluded that they could not do anything further for me since all their extensive testing all came up negative other then the COVID antibody levels and started me on the same steroid via IV on February 10, 2021 and on February 11, 2021 I was released from Hospital with a 28-day gradual reduction of the steroid over that timeframe to see if the COVID antibody production would simply stop. They had no other recourse or follow up with for any of the specialists. I?m on my own at this point and scared. To help with the inflammation the only thing my wife and I saw we could do is see a health and well Doctor to try and purge myself of the inflammation and assist my bowel and liver health with trying to rid me of the vaccine and hopefully the antibody production. I?m on a strict diet and taking supplements to assists in the reduction of inflammation and cleaning my system out. Starting today, February 18, 2021 I start stepping back on the steroids prescribed by Hospital and praying that the symptoms and pain simply go away but I?m still having night sweats, weak and shaky.",Not Reported,,Not Reported,Yes,11.0,Not Reported,N,01/06/2021,01/21/2021,15.0,WRK,None,None,None,,None,"['Arthralgia', 'Blood test', 'Chest X-ray normal', 'Chest pain', 'Cold sweat', 'Colonoscopy abnormal', 'Computerised tomogram abdomen normal', 'Computerised tomogram spine', 'Endoscopy', 'Faeces discoloured', 'Fear', 'Haematochezia', 'Headache', 'Hyperhidrosis', 'Inflammation', 'Large intestine polyp', 'Myalgia', 'Pain', 'Pain in extremity', 'Platelet count decreased', 'Polypectomy', 'Red blood cell sedimentation rate increased', 'SARS-CoV-2 antibody test positive', 'SARS-CoV-2 test negative', 'Thrombosis', 'White blood cell count increased', 'X-ray limb']",1,MODERNA,SYR 1038347,MO,89.0,M,"Developed chest pain, severe shortness of breath during the night following the vaccine. NO chest pains were reported for the previous 4 years prior to the vaccine. Was rushed to the hospital. Several tests were completed. Troponins were elevated but no EKG changes. Not able to complete a cardiac Cath d/t pt being too weak. Pt placed on hospice and sent back to facility.",Not Reported,,Yes,Yes,7.0,Yes,N,02/09/2021,02/10/2021,1.0,SEN,,,"CHF, CAD",,,"['Asthenia', 'Catheterisation cardiac', 'Chest pain', 'Condition aggravated', 'Dyspnoea', 'Electrocardiogram', 'Laboratory test', 'Troponin increased']",1,MODERNA,IM 1038358,CA,84.0,M,Development of chest pain and dyspnea. Large pleural and pericardial effusions requiring drainage. No evidence of CHF by echo or BNP. Fluid was found to be exudative rather than transudative. No growth of infectious agents found to be causal. ESR and CPR extremely elevated. All self resolving after thoracentesis and pericardiocentesis.,Not Reported,,Yes,Yes,3.0,Not Reported,U,01/30/2021,01/31/2021,1.0,PVT,"Medication Details Provider Last Reconciliation Status gabapentin (NEURONTIN) 300 MG capsule Take 1,200 mg by mouth nightly. 900mg morning, afternoon 1200mg bedtime Historical Zzzprovider, MD Needs Review Reviewed Prior to Admission Medica",NO,? Asbestosis (CMS/HCC) � ? BPH (benign prostatic hyperplasia) � ? Chronic sinusitis � ? CKD (chronic kidney disease) � ? Diabetes mellitus (CMS/HCC) � � Type 2 ? MGUS (monoclonal gammopathy of unknown significance) � ? Nephrolithiasis � ? Neuropathy � � Lower Extremity ? Osteopenia � ? Proteinuria � ? PVD (peripheral vascular disease) (CMS/HCC) � ? Rheumatoid arthritis (CMS/HCC) � � stem cell knees ? Sleep disorder,,No,"['Aspiration pleural cavity', 'C-reactive protein increased', 'Chest pain', 'Dyspnoea', 'Echocardiogram', 'Echocardiogram normal', 'Inflammation', 'Pericardial drainage', 'Pericardial effusion', 'Pericarditis', 'Pleural effusion', 'Red blood cell sedimentation rate increased', 'Thoracic cavity drainage']",1,PFIZER\BIONTECH,IM 1038383,MI,60.0,F,"Pt received Moderna vaccine, 2nd dose on 2/15/2021. She was subsequently admitted to the hospital for fever and Seizure on 2/16. Pt also noted to have fever ~104F. She does have a history of seizure disorder and is maintained on anti seizure medication. Suspect the seizure related to high fever ~104F possibly from her vaccination.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/15/2021,02/16/2021,1.0,SEN,,,,,,"['Condition aggravated', 'Pyrexia', 'Seizure']",2,MODERNA, 1038397,ID,53.0,M,"About 30-45 minutes post dose. Dizziness, lightheadedness, warmth, chest pain/pressure, SOB",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/15/2021,02/15/2021,0.0,PVT,"Escitalopram, potassium, pantoprazole, furosemide, gabapentin, metformin, hydrochlorothiazide, isosorbide, novolog, amlodipine, humalog, atorvastatin, clopidogrel, carvedilol, dicyclomine, flovent, ranitidine, sucralfate, lisinopril, acetam",None reported in chart,"Cardiomyopathy, heart failure, hypertension, left ventricular hypertrophy, coronary artery disease, psoriasis, carpal tunnel syndrome, seizure, bell's palsy, type II Diabetes mellitus, diabetic neuropathy, crohn's disease, ADHD, tobacco use, mixed hyperlipidemia, class 2 obesity",,"Aspirin, sulfa","['Blood glucose', 'Blood urea', 'Brain natriuretic peptide', 'Chest X-ray', 'Chest discomfort', 'Chest pain', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Feeling hot', 'Fibrin D dimer', 'Full blood count', 'Metabolic function test']",2,MODERNA,IM 1038403,WI,58.0,F,admitted to hospital for a stroke,Not Reported,,Not Reported,Yes,,Not Reported,U,02/13/2021,02/15/2021,2.0,PVT,,,,,,['Cerebrovascular accident'],2,PFIZER\BIONTECH,IM 1038438,OK,59.0,F,"episode of amnesia, occurring on 16 Feb 2021 for about 30 to 45 minutes, (no recall of memory to this time); mild confusion/sluggish thinking lasting about 24 - 36 hours afterwards.. No physical droopiness or paralysis; negative work-up for stroke done in ER, TIA could not be ruled out.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/03/2021,02/16/2021,13.0,MIL,Aspirin 325 mg Combigan 0.2%-0.5% Fluorometholone 0.1% Losartan 25 mg every other day Metoprolol XL 25 mg HCTZ 25 mg Lipitor 10 mg Protonix 20 mg Wellbutrin 150 mg Metformin 1000 mg bid Junavia 100 mg Vitamin D w/Ca++ 2000 iU,none,HTN Hyperlipidemia DM II Arthritis,,Percocet,"['Amnesia', 'Blood test normal', 'Bradyphrenia', 'Chest X-ray normal', 'Computerised tomogram head', 'Computerised tomogram head normal', 'Confusional state', 'Echocardiogram', 'Echocardiogram normal', 'Electrocardiogram normal', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging brain normal']",2,PFIZER\BIONTECH,IM 1038442,IL,56.0,M,Death within thirty days of vaccine. Multiple co-morbidities and placed on hospice 12/28/20.,Yes,01/06/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,OTH,Hospital discharge medications 12/28/20: Tylenol prn; ativan prn; morphine prn; scopolamine prn all other medications were discontinued,Inpatient 12/21/20 with COVID (+ test 12/17/20) and cellulitis of leg treated with antibiotics. Readmitted 12/25-12/28 with seizures and acute kidney injury discharged to SNF on hospice care.,"Obesity, TBI, quadriplegia secondary to GSW; COPD; seizures; gout; neurogenic bowel and bladder; major depressive disorder; dextroscollosis; DM",,NKA,"['Blood chloride increased', 'Blood creatinine increased', 'Blood glucose increased', 'Blood potassium increased', 'Blood sodium increased', 'Blood urea increased', 'Death', 'Drug screen positive', 'Glomerular filtration rate decreased']",1,PFIZER\BIONTECH,IM 1038446,KS,19.0,F,"Rash on abdomen, arms/chest/abdomen itching, short of breath",Not Reported,,Not Reported,Yes,,Not Reported,N,02/17/2021,02/17/2021,0.0,PVT,None,None,Asthma,Influenza vaccine-gets high fever within hour,None,"['Dyspnoea', 'Pruritus', 'Rash']",1,MODERNA,IM 1038447,AL,92.0,M,Ischemic stroke on Saturday morning following vaccine Thursday. Symptoms were muscle weakness and inability to speak,Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,01/21/2021,01/23/2021,2.0,PVT,"simvastatin, hydrochlorothiazide, buspirone, quinapril, ovuvite, B12, aspirin",none,high blood pressure,,none,"['Aphasia', 'Ischaemic stroke', 'Muscular weakness']",1,PFIZER\BIONTECH,IM 1038473,NY,71.0,F,"1 week after receiving first dose of Pfizer COVID vaccine (received 1/26/2021), develop worsening shortness of breath. Presented to ER on 2/4/2021. Found to have submassive pulmonary embolism with evidence of right heart strain, US showed left lower extremity DVT. Also found to have descending aortic thrombus with extensive clot burden. Was hypoxic 89% on room air.",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,01/26/2021,02/05/2021,10.0,PVT,"Paroxetine 20 mg daily, Simvastatin 20 mg daily, Amlodipine 10 mg daily, atenolol 100 mg daily, losartan 25 mg daily, fluticasone 50 mcg daily nasal spray, omeprazole 20 mg daily, zolpidem 10 mg daily","hypertension, hyperlipidemia, GERD","history of necrotizing pneumonia with pulmonary washout in 2017 Ductal carcinoma in situ of left breast s/p lumpectomy and radiation in 2017, no hormone therapy. No evidence of recurrence of disease. Mammogram in 6/2020 without evidence of recurrence",,Macrobid- rash,"['Aortic thrombosis', 'Cardiac disorder', 'Computerised tomogram thorax', 'Deep vein thrombosis', 'Dyspnoea', 'Echocardiogram', 'Electrocardiogram', 'Electrocardiogram ST-T segment abnormal', 'Hypoxia', 'Lung opacity', 'Pulmonary embolism', 'Right ventricular hypertrophy', 'Thrombosis', 'Ultrasound Doppler', 'Ultrasound scan abnormal']",UNK,PFIZER\BIONTECH,IM 1038489,FL,77.0,M,The patient experienced a cardiac arrest 2 days after receiving the second dose of the Covid-19 vaccine. He later died on 2-17-2021 with complications including respiratory arrest and acute kidney failure.,Not Reported,,Not Reported,Yes,15.0,Not Reported,N,02/02/2021,02/04/2021,2.0,PUB,,"Nonischemic cardiomyopathy, diabetes mellitus II, chronic back pain , HTN","Nonischemic cardiomyopathy, diabetes mellitus II, chronic back pain , HTN",,"amoxicillin, ampicillin, tetanus toxoid","['Acute kidney injury', 'Cardiac arrest', 'Death', 'Respiratory arrest']",2,MODERNA,IM 1038491,,28.0,F,"Patient was newly pregnant, received 2nd dose of covid vaccine. Patient then began bleeding on 2/13/21. On 2/15/21 confirmed with OBGYN that HCG levels were low and that she was having a miscarriage. Patient has a healthy 2 year old living child. No past history of miscarriages, no family history of miscarriage.",Not Reported,,Not Reported,Not Reported,,Yes,,01/20/2021,02/13/2021,24.0,UNK,,,,,,"['Abortion spontaneous', 'Exposure during pregnancy', 'Haemorrhage', 'Human chorionic gonadotropin decreased']",2,PFIZER\BIONTECH,SYR 1038493,NY,84.0,F,"The morning after vaccination, she felt extremely and unusually fatigued. After getting up from bed and eating her usual breakfast, she was returning to her bedroom when she became dizzy and fainted, falling to the floor, hitting her head and suffering other effects, including rhabdomyolysis from being on the floor for a long time after the fall as she was unable to get up. She was transported to the ER and was admitted to the hospital for 3 days. She was treated with IV fluids, Tylenol and a short course of antibiotics. While hospitalized, she had a repeat of a rash/swelling at injection site that began about 48 hours after vaccination. The hospital treated the rash with some barrier cream and within 48, the redness, rash and swelling abated.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/11/2021,02/12/2021,1.0,PHM,"Supplements: Centrum Silver Multivitamin, Ocuvite, Omega 3-Krill Oil, Garlique, Caltrate Calcium Supplement",None,None,"As reported separately, patient suffered injection site and arm swelling, itching and rash that began 10 days after vaccination ",None,"['Blood test', 'Computerised tomogram normal', 'Dizziness', 'Erythema', 'Fall', 'Fatigue', 'Head injury', 'Injection site rash', 'Injection site swelling', 'Mobility decreased', 'Rhabdomyolysis', 'Syncope']",2,MODERNA,IM 1038497,IN,46.0,M,"1/10/2021-Approximatley 34 hours after vaccination developed left facial numbness followed by severe dysequilibrium 5 hours later. 1/11/2021-left facial numbness and dysequilbrium significantly worse along with severe rotary nystagmus in the left eye. Had appointment with primary care and then ENT , who started me on prednisone 30 mg and antivert. ENT refered me to Neurology. Neurology ordered MRI/MRA that night and increased my prednisone to 60mg/day for 5 days followed by a taper over next five days. Currently, Symptoms of dysequilibrium and numbness have not subsided, on a second course of prednisone 60 mg/day for 3 days followed by taper. MD , Neurologist, provided Diagnosis of vaccine induced polyneuropathy affecting cranial nerves 5 and 8. Since the onset on January 10, Cannot work(physician/anesthesiologist) , drive, or perform minor tasks due to the severity of the symptoms. Symptoms during 1/10/21-1/17-21, bed-ridden, slept 18-20 hours/day, could not walk without assistance-would fall to the left, could not read, nystagmus of left eye, had to keep eyes closed due to severe vertigo/dysequilibrium, nausea. 1/18/21-1/24/21 slight improvement in disequilibrium/able to walk, no change in facial numbness severity , started on 100 mg gabapentin at night, and low dose valium 1.25 mg to 2.5 mg to help with dysequilibrium 1/25/21-1/29/21 50% improvement in facial numbness, began vestibular PT, slow improvement in dysequilibrium and ability to walk and read 1/30/21 Symptoms worsened again, facial numbness returned, dysequilibrium returned to its original severity, difficulty reading/focusing 2/1/21 Followed up with Dr, started another prednisone 60mg/day for 3 days, followed by taper over the next 5 days 2/4/21 Left Facial numbness not improved, dysequilibrium still severe, having difficulty focusing and reading",Not Reported,,Not Reported,Not Reported,,Yes,N,01/09/2021,01/10/2021,1.0,PVT,"Losartan. Hctz, Synthroid, Cytomel, Singulair",None,"HTN, Hypothyroid,",,None,"['Angiogram normal', 'Audiogram normal', 'Balance disorder', 'Blood thyroid stimulating hormone normal', 'C-reactive protein normal', 'CSF culture negative', 'Full blood count normal', 'Gait disturbance', 'Hypersomnia', 'Hypoaesthesia', 'Impaired driving ability', 'Impaired work ability', 'Loss of personal independence in daily activities', 'Lumbar puncture normal', 'Magnetic resonance imaging normal', 'Metabolic function test normal', 'Nausea', 'Nystagmus', 'Polyneuropathy', 'Treponema test negative', 'Vertigo', 'Vision blurred']",2,PFIZER\BIONTECH,IM 1038517,MN,68.0,M,Pt. received vaccine on 2/3/2021. Coded at home on 2/17/2021.,Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/17/2021,14.0,WRK,unknown,unknown,unknown,,unknown,"['Cardio-respiratory arrest', 'Death', 'SARS-CoV-2 test negative']",1,MODERNA,IM 1038527,SD,71.0,F,Per EMS/Hospital report patient had difficulty breathing and cardiac arrest with prolonged CPR (greater than 45 mins in the ER) who was resuscitated. Family subsequently arrived including son and daughter and all family members were in the ER room are in agreement that patient would not want further aggressive cares given her extremely poor prognosis in light of chronic debilitation with numerous medical issues and now a very long period of CPR. Hospital Course After updating family they stated patient would not want further aggressive cares given her grim prognosis and chronic severe and debilitating medical issues. She continued to have myoclonic jerking. She was extubated to comfort cares in the ER and did not pass immediately therefore brought to a room. She received comfort cares and passed away at 0450 with family present.,Yes,02/18/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,OTH,Unsure. Possibly the following from hospital EHR: albuterol sulfate 90 mcg/actuation inhalation 2 times daily PRN amlodipine besylate 10 mg oral Daily aspirin 81 mg oral Daily atorvastatin calcium 40 mg oral Daily carvedilol 6.25 mg oral 2,"Arthritis hands Cardiovascular disease dyslipidemia Chronic bronchitis COPD (chronic obstructive pulmonary disease) Coronary artery disease History of transfusion Hypertension Myocardial infarction stent Peripheral vascular disease Psychiatric illness ""feels depressed"" on ocassion Renal artery stenosis TIA (transient ischemic attack) ""short spurts"" of tingling on face Urge incontinence of urine","Arthritis hands Cardiovascular disease dyslipidemia Chronic bronchitis COPD (chronic obstructive pulmonary disease) Coronary artery disease History of transfusion Hypertension Myocardial infarction stent Peripheral vascular disease Psychiatric illness ""feels depressed"" on ocassion Renal artery stenosis TIA (transient ischemic attack) ""short spurts"" of tingling on face Urge incontinence of urine",,"epinephrine, penicillin, procaine per EHR","['Cardiac arrest', 'Death', 'Dyspnoea', 'Endotracheal intubation', 'Myoclonus', 'Resuscitation']",1,MODERNA,IM 1038561,CO,79.0,M,"(02/15/2021): vaccine (02/16/2021) : severe body aches and weakness, increased congestion and mucous production. (02/16-17/2021) : death possibly during the night",Yes,02/16/2021,Not Reported,Not Reported,,Not Reported,,02/15/2021,02/16/2021,1.0,OTH,Trazodone,"AAA, GERD,HTN, CAD, CA, arthritis","AAA, GERD, HTN, CAD, CA, arthritis",,Unknown,"['Asthenia', 'Death', 'Pain', 'Respiratory tract congestion', 'Secretion discharge']",2,PFIZER\BIONTECH, 1038573,DC,78.0,M,Pt. was hospitalized with acute hypoxic respiratory failure due to severe COVID-19 complicated by acute kidney injury and exacerbation of heart failure on 2/8/2021.,Not Reported,,Not Reported,Yes,10.0,Not Reported,Y,01/28/2021,02/08/2021,11.0,PVT,"Colchicine 0.6mg Tab Take One Tablet by Mouth As Directed On Package Take 2 Tablets At Onset Of Gout, Then Take 1 Tablet 1 Hour Later. Then Take 1 Tablet Once A Day for 5-7 Days Cetirizine Hcl 10mg Tab Take One Tablet by Mouth Every Day",likely recurrence of rectal cancer,essential hypertension chronic kidney disease prostate cancer rectal cancer s/p hemicolectomy diastolic heart failure,,lisinopril - lip swelling,"['Acute kidney injury', 'Acute respiratory failure', 'COVID-19', 'Cardiac failure', 'Chest X-ray abnormal', 'Condition aggravated', 'Hypoxia', 'Lung opacity', 'Pleural effusion', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1038579,IN,95.0,M,Death,Yes,02/16/2021,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/16/2021,1.0,PUB,prednisone,COPD HTN Lung Cancer,COPD HTN Lung Cancer Prostate Cancer,,none,['Death'],2,PFIZER\BIONTECH,IM 1038582,IA,60.0,M,"Few days after receiving the 1st dose, developed tingling paresthesia in both hands. He received his second vaccination despite the symptoms. Symptoms continued to progress to his feet, and also developed weakness, particularly in his legs. Also had some weakness in arm but more so on the left side. He had difficulty climbing ladder when deer hunting due to weakness in his thighs/legs. He ended up falling in his home on Jan 17, 2021 as well, which caused significant hip pain. Had a neurosurgical evaluation- finding lumbar disease L3-4 requiring fusion. Following surgery, paresthesia and weakness persisted and actually worsened, , developed uncontrolled twitching in both thighs. Further developed loss of function in his L-hand. MRI revealed transverse myelitis. Symptoms have improved with corticosteroid therapy. Patient was hospitalized due to these symptoms for two days, discharged on corticosteroids.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,12/17/2020,12/24/2020,7.0,PVT,"amlodipine, gabapentin, hydrochorothiazide, losartan, meloxicam, pantoprazole",none,"hypertension, GERD, history of prostate cancer",,NKA,"['Arthralgia', 'Asthenia', 'CSF culture', 'CSF test', 'Computerised tomogram thorax', 'Condition aggravated', 'Fall', 'Intervertebral disc disorder', 'Lumbar puncture', 'Magnetic resonance imaging abnormal', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging spinal', 'Muscle twitching', 'Muscular weakness', 'Musculoskeletal disorder', 'Myelitis transverse', 'Paraesthesia', 'Spinal fusion surgery']",2,PFIZER\BIONTECH,IM 1038593,IA,74.0,M,"Thrombocytopenia, oral lesions, and bloody nose. Treated with 1 unit of platelets. Outcome pending.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/13/2021,02/17/2021,4.0,PHM,no record of medication,unknown,unknown,,no allergies listed,"['Epistaxis', 'Oral disorder', 'Platelet transfusion', 'Thrombocytopenia']",1,MODERNA,IM 1038609,NY,73.0,M,"Atrial fibrillation, ischemic stroke right internal capsule, ER, tpa, recovered much of neurologic deficit",Not Reported,,Yes,Yes,9.0,Yes,N,01/27/2021,02/03/2021,7.0,PVT,st johns wort metformin 500mg bid,type 2 diabetes,,,none,"['Atrial fibrillation', 'Internal capsule infarction', 'Ischaemic stroke']",2,MODERNA,IM 1038625,MI,54.0,M,"Pt resides at an facility, normally communicative and interactive. Received his second dose of the Moderna COVID-19 vaccine 2/15 and complained of a head ache after. The morning of 2/16 he was found to have a fever of 104.8, altered mental status, possible seizure like activity and taken to ED. ID consulted due to high fever, AMS, LP recommended to rule out meningitis. Due to the patient being on warfarin he needed to be reversed first which was done. The following day he was back to his baseline and afebrile. LP was canceled at that time.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/15/2021,02/16/2021,1.0,PVT,"Amiodarone 200mg BID, atorvastatin 80mg daily, benztropine 0.5mg HS, Buspar 15mg TID, Tegretol 300mg TID, Depakote DR 1000mg TID, Famotidine 20mg BID, Synthroid 50mcg daily, Mag OX 400mg bid, Metformin 500mg daily, lopressor 50mg BID, Mira","Leg Swelling, onset 2 years but getting worse. hand Pain, numbness.","DM2, Gait Instability, A-flutter, Depression, Bipolar, GERD, Hyperlipidemia, Hypothyroidism, Traumatic brain injury from MVC, Seizures.",,"Penicillin VK, Cyclodrine, Tetracycline.","['Blood creatine phosphokinase', 'Blood culture', 'Blood lactic acid', 'Coagulation test', 'Full blood count', 'Headache', 'Mental status changes', 'Metabolic function test', 'Procalcitonin', 'Pyrexia', 'SARS-CoV-2 test']",2,MODERNA,IM 1038635,SD,97.0,F,"The patient fell the day after receiving the Moderna COVID-19 vaccine. She broke her hip in this fall. During surgery to correct the broken hip, she went in to sudden and unexpected cardiac arrest. The anesthetist did not notice any ST changes or A fib; dysrhythmia was very unexpected. The patient had a DNR. She died at 13:00 on 02/07/2021. Causes of death are listed as 1. Cardiac Arrest 2. Recent hip fracture with hip placement 3. History of Breast Cancer 4. Hypothyroid and 5. Dementia",Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,UNK,"Aspirin 81 mg enteric-coated q a.m. Plavix 75 mg po at bedtime Iron, Ferrex-150 25/1/150 tid with meals Folic acid 1 mg bid Metoprolol tartrate 25 mg bid MiraLAX 8.5 gm daily Synthroid 100 mcg a day Tamsulosin 0",A fall occurred on the day after vaccination; she fractured her hip in this fall. The physician reports she went into sudden and unexpected cardiac arrest during surgery and died. Patient had COVID-19 approx 11/06/2020. Possible urinary tract infection on admit for the fall,"History of breast cancer (bilateral; patient is post-bilateral masectomy) Hypothyroid Dementia (""always confused about time and place"") Recurrent urinary tract infections The patient was admitted August 2020 with suspected seizure but this was attributed to UTI and/or dementia) Hypertension Diffuse Arthritis Resident of assisted living facility",,Erythromycin Codeine,"['Arrhythmia', 'Cardiac arrest', 'Death', 'Dementia', 'Fall', 'Hip arthroplasty', 'Hip fracture', 'Hypothyroidism']",UNK,MODERNA,UN 1038658,DC,86.0,F,"86yo female alert, stable with ankle abrasion eating 100% prior to vaccine in assisted living facility. On 2/1/2021, received Moderna vaccine. Starting thereafter, eating 50% on 2/2/21. Temperature was 98 tympanic. On 2/3, the leg abrasion started having moderate bleeding. On 2/4, the caregiver noted patient ""not looking good, unable to talk, arms moving aimlessly, grasping"". BP 95/41, temperature 98, oxygen on room air 92-93%. POA did not want hospital transfer. 2/5 Hospice started, oxygen given, morphine given. 2/5-2/8 comfort care given, patient responsive to tactile stimuli, resting, not taking oral medications or food. 2/8/2021 patient expired.",Yes,02/08/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/08/2021,7.0,SEN,"atenolol, docusate, calcium/vitamin D, furosemide, tamoxifen, multivitamin, trazodone, vitamin b12, vitron C",ankle/leg wound healing and being treated topically,"history of TIA, breast neoplasm, dementia",,none,"['Aphasia', 'Death', 'Decreased appetite', 'Dyskinesia', 'Gait inability', 'Oxygen therapy', 'SARS-CoV-2 test negative']",UNK,MODERNA,IM 1038670,WI,89.0,M,The patient received the vaccine on 1/27/21. He had a therapeutic INR on 1/25/21 and also on 2/15/21. On 2/3/21 he developed expressive aphasia with naming difficulties and generalized weakness. CT brain on 2/15/21 showed a left hemisphere subcortical infarction. He has been on warfarin for atrial fibrillation for 9 years without any strokes prior to this.,Not Reported,,Not Reported,Not Reported,,Yes,N,01/27/2021,02/03/2021,7.0,PVT,"atorvastatin 20mg daily, losartan 25mg daily, metoprolol 200mg daily, isosorbide mononitrate 60mg daily, pramipexole 1mg nightly, warfarin 5mg daily",,"atrial fibrillation, bradycardia with pacemaker",,codine,"['Aphasia', 'Asthenia', 'Computerised tomogram head', 'Infarction']",1,PFIZER\BIONTECH,IM 1038697,GA,85.0,M,Patient developed symptoms of Covid-19 pneumonia on 2/10/2021. He was treated as an outpatient by his PCP. On 2/15/2021 he was admitted to the hospital with Covid-19 pneumonia and hyponatremia.,Not Reported,,Not Reported,Yes,,Not Reported,U,01/27/2021,02/10/2021,14.0,PVT,,,,,,"['COVID-19 pneumonia', 'Hyponatraemia']",1,PFIZER\BIONTECH,IM 1038712,CA,54.0,F,"abdominal pain, orange urine, jaundice, auto immune hepatitis: in hospital for week",Not Reported,,Not Reported,Yes,,Not Reported,N,01/11/2021,01/26/2021,15.0,OTH,"parazodone, viidyre",,,,"latex,bees","['Abdominal pain', 'Autoimmune hepatitis', 'Chromaturia', 'Jaundice']",1,MODERNA,IM 1038719,AZ,80.0,F,death attributed to unknown cause,Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,U,01/30/2020,01/18/2021,354.0,PUB,,,,,,['Death'],1,MODERNA,IM 1038720,NY,99.0,F,"Resident complained about back pain in the middle of the night and when they went to do a blood pressure examination, she passed away at 2:40 am.",Yes,02/18/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/18/2021,1.0,SEN,,,,,,"['Back pain', 'Death']",2,PFIZER\BIONTECH,IM 1038721,ID,19.0,F,"SOB, ended up being hospitalized",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/01/2021,02/01/2021,0.0,SEN,Unknown,Pancreatic Cancer,Pancreatic Cancer,,None,['Dyspnoea'],1,PFIZER\BIONTECH,IM 1038732,LA,72.0,M,"Acute on chronic congestive heart failure, unspecified heart failure type; Cough; ESRD (end stage renal disease); Hypertension, unspecified type; SOB (shortness of breath); Shortness of breath",Not Reported,,Not Reported,Yes,,Not Reported,N,02/13/2021,02/15/2021,2.0,UNK,,,,,,"['Cardiac failure acute', 'Cardiac failure congestive', 'Cough', 'Dyspnoea', 'End stage renal disease', 'Hypertension']",1,PFIZER\BIONTECH, 1038778,IN,95.0,M,Patient developed shortness of breath and weakness the morning after he received the COVID vaccine. He also reported diarrhea and fatigue. Per the patient he went to 2 urgent cares before being referred a day or 2 later to the emergency department. The patient was diagnosed with NSTEMI and later transferred hospital.,Not Reported,,Not Reported,Yes,,Not Reported,Y,02/09/2021,02/10/2021,1.0,PUB,"Amlodipine, Prolia, Eligard, Multivitamin",,"Aortic valve stenosis, paroxysmal atrial fibrillation, hypertension, prostate cancer, hyperlipidemia",,No Known Allergies,"['Acute myocardial infarction', 'Asthenia', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Troponin increased']",1,MODERNA,IM 1038786,MS,80.0,M,"FEVER, CHILLS, SOB, RAPID HEART RATE; HOSPITAL ADMISSION 02/13/2020 TO PRESENT",Not Reported,,Not Reported,Yes,,Not Reported,N,02/12/2021,02/13/2021,1.0,PVT,"ascorbic acid (Tablet) ascorbic acid (vitamin C) 500 MG Take 500 mg by mouth one (1) time a day cholecalciferol (vitamin D3) (Capsule) cholecalciferol 5,000 unit (125 mcg) Take 5,000 Units by mouth 2 (two) times a day 2 tabs daily cyanoco",NONE,"A FIB, VITAMIN B12 DEF, HYPERLIPIDEMIA, HTN, OA, HX TIA, HX SKIN CANCER, ESRD, RENAL ARTERY STENOSIS, PLEURAL EFFUSION, COPD, DIALYSIS",,NKA,"['Chills', 'Dyspnoea', 'Heart rate increased', 'Pyrexia']",2,MODERNA,IM 1038810,PA,39.0,F,"Overnight 1/8 /21 developed mild right lower quadrant pain, did not change with NSAIDs or acetaminophen. Given location, went to ER for evaluation and diagnosed with acute appendicitis. Underwent laparoscopic appendectomy 1/9/21.",Not Reported,,Not Reported,Yes,2.0,Not Reported,,01/05/2021,01/08/2021,3.0,WRK,None,None,High cholesterol,,None,"['Abdominal pain lower', 'Appendicectomy', 'Appendicitis', 'Computerised tomogram', 'Laboratory test', 'Laparoscopic surgery']",1,MODERNA,IM 1038813,CO,70.0,F,"Nausea, flushed, dizzy, after about 20 minutes my throat closed, unable to breath. The workers did not know how to use epi-pen. I used my own epi- pen, ENT used heart monitor, intervenious Benadryl was administered, I was transport to ER at hospital, treatment with more meds, prednisone. I was kept in ER for several hours for monitoring. I had no more reaction.Y",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/13/2021,02/13/2021,0.0,OTH,"Levothyroxine, Lexapro, Topamax, Repatha, Magnesium, Calcium, D, Cranberry",Healthy. Visually impaired,None,,"Augmenting, Amoxicillin, Penicillin, Keflex, Bactrim, Ultram/Tremidal, Demerol. Now Phiser vaccine","['Cardiac monitoring', 'Dizziness', 'Dyspnoea', 'Flushing', 'Nausea', 'Throat tightness']",2,PFIZER\BIONTECH,IM 1038833,IN,72.0,F,"Vaccine Tuesday 2/9, flu like symptoms 2/10, abdominal pain 2/11, pain worsens, nausea, admitted to hospital 2/11. On saline drip until Monday 2/15. Pancreas pain and partial bowel obstruction, low contrast test on 2/14, blockage moved and was expelled. Seeing GI specialist 2/19. Pancreas duct dialated",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/09/2021,02/10/2021,1.0,PUB,"Prempro, fluoxatine, lunesta, propanerol, cholysterimine, baby aspirin, vit d,imodium",None,None,,"E-myacin, colace","['Abdominal pain', 'Abdominal pain upper', 'Blood test normal', 'Computerised tomogram abdomen abnormal', 'Influenza like illness', 'Intestinal obstruction', 'Nausea', 'Pain', 'Pancreatic duct dilatation']",2,UNKNOWN MANUFACTURER,IM 1038835,WA,74.0,M,"Thrombocytopenia - admitted to the hospital with platelets of 2, hematuria, petechial rash",Not Reported,,Yes,Yes,5.0,Not Reported,Y,01/25/2021,02/12/2021,18.0,PVT,"Ubidecarenon, Mecobalamin, Ferrous sulfate, Donepezil, Jardiance, Isosorbide Dinitrate, Lovastatin, Lisinopril/HCTZ, Metformin, Metoprolol Succinate, Cholecalciferol, Humalog, Levemir, Xyosted","CAD, Diabetes, HTN",As above,,No known allergies,"['Haematuria', 'Petechiae', 'Platelet count decreased', 'Red blood cell sedimentation rate increased', 'Thrombocytopenia']",1,MODERNA,IM 1038862,MI,82.0,M,"A fast heartbeat; Dizziness and weakness. Went to ED - ""Patient is an 82yo male with a history of chronic Afib on Eliquis, HTN, and bradykinesia (thought to be PD) who presented to the ED with a CC of weakness after receiving 2nd dose of COVID-19 vaccine. He also had low-grade fever and difficulties ambulating. In the ED he was febrile at 38.5C and HR 159bpm. EKG revealed Afib RVR. BP was stable. He was given Cardizem 10mg IV x1. Basic labs were unremarkable. COVID negative. CXR negative. He was given Tylenol for fever and admitted under observation. He remained afebrile and heart rate remained controlled with home Cardizem dosing. Cardiology was consulted who will refer him to their clinic to establish routine care with their service. PT/OT recommended home with home PT/OT. The patient overall felt much improved compared to admission and felt ready for discharge. He was discharged home in stable condition.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/10/2021,02/11/2021,1.0,PUB,"Eliquis, Sinemet, Dilt-XR, Cardizem, Cozaar, Crestor, Flomax, Vitamin D3, cyanocobalamin",,"Diverticulosis, Hypertension, A-fib, Oral thrush, bradykinesia (possible Parkinson's)",,Amoxicillin,"['Asthenia', 'Atrial fibrillation', 'Chest X-ray normal', 'Dizziness', 'Electrocardiogram abnormal', 'Gait disturbance', 'Heart rate increased', 'Laboratory test normal', 'Pyrexia', 'SARS-CoV-2 test negative']",2,MODERNA,IM 1039028,IN,59.0,M,"Systemic: no issues during observation period-Severe, Additional Details: patient received moderna immunization during the morning of 2/17/2021. patient was found by facility staff at 2:38pm with no pulse CPR was started, aed was used and ems was called. time of death 3:15pm",Yes,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,SEN,,,,,,"['Cardioversion', 'Death', 'Resuscitation']",2,MODERNA,IM 1039058,MA,58.0,F,"Stomach pain, nausea, back pain, acute appendicitis by 02/17/2021 appendectomy on 02/17/2021",Not Reported,,Yes,Yes,1.0,Not Reported,Y,02/12/2021,02/13/2021,1.0,PVT,,,,,,"['Abdominal pain upper', 'Appendicectomy', 'Appendicitis', 'Back pain', 'Blood test', 'Computerised tomogram', 'Nausea', 'Urine analysis']",2,MODERNA,IM 1039090,SD,91.0,F,"The patient came to the Emergency Room at approx 3:30 am on 02/03/2021 with pain in right arm (same arm the COVID vaccine had been administered in approx 12 hours earlier) and feeling generally unwell. Patient was concerned about possibility of gout flare or that something was wrong with her arm. Elevated blood pressure was noted; this was attributed to anxiety. She was evaluated, given 500 mg Tylenol, and discharged since the pain was decreasing and blood pressure was stabilized. Patient instructed to follow-up with physician. The next day, on 02/04/2021, the patient arrived at the Emergency Room by ambulance; cardiac arrest was the chief complaint. The patient's daughter stated the patient had been ""feeling generally poor and then suddenly collapsed."" Daughter described ""gurgling respirations"" and being unresponsive. 911 was called, police arrived within 5 minutes and initiated CPR. Epinephrine, atropine, lidocaine and bicarb administered after arrival to Emergency Room. Shockable rhythm never demonstrated. Patient never recovered spontaneous respiration or movement. The death was called at 23:04. Coronary artery disease with cardiac arrest is the cause from the ER records; the coroner is putting COVID-19 vaccination in Part 1 of the death certificate.",Yes,02/04/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/03/2021,1.0,UNK,,,GERD (Gastroesophageal Reflux Disease) Hypertension Previous Squamous Cell Skin Cancer,,,"['Anxiety', 'Blood pressure increased', 'Breath sounds abnormal', 'Cardiac arrest', 'Coronary artery disease', 'Death', 'Malaise', 'Pain in extremity', 'Resuscitation', 'Syncope', 'Unresponsive to stimuli']",UNK,MODERNA,SYR 1039123,MD,49.0,M,Fatigue then sudden onset dyspnea with exercise in previously well and athletic physician/ health care worker,Not Reported,,Not Reported,Not Reported,,Yes,N,01/12/2021,02/05/2021,24.0,PVT,,,,,,"['Angiogram pulmonary normal', 'Blood thyroid stimulating hormone normal', 'Dyspnoea exertional', 'Echocardiogram abnormal', 'Fatigue', 'Full blood count normal', 'Metabolic function test normal', 'Pulmonary hypertension']",2,PFIZER\BIONTECH,IM 1039141,FL,79.0,M,"2/9/21 plt ct 33 (baseline 78), 2/10/21 plt ct 46, 2/11/21 plt ct 6 then 3, admitted to hospital, given high dose steroids and IVIG, symptoms now improving, but experiencing ongoing thrombocytopenia",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,02/07/2021,02/09/2021,2.0,PVT,none,"follicular lymphoma, received rituxan until 9/2020, last cbc 1/8/21 plt 78, repeat cbc on 2/9/21 plt ct 33, 2/10/21 plt ct 46, 2/11/21 plt ct 6, repeat 3.",follicular lymphoma,,nka,"['Immunoglobulin therapy', 'Platelet count decreased', 'Thrombocytopenia']",UNK,MODERNA, 1039142,SC,30.0,F,"I basically had all of the symptoms of Covid. I exp nausea, diarrhea, 103. temp, chills(got fever under control was gone in a day), body ache,congestion lasted 3 days. I went to the ER twice first time discharged to go home rest and second time told it might of been food poisoning,",Not Reported,,Not Reported,Yes,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,Lexapro,Acid Reflux,"Acid Reflux ,Gallbladder removal","flu vaccine(pain around the injection site, headache few days 3 at the most)","Tomatoes, Cats","['Chest X-ray', 'Chills', 'Diarrhoea', 'Nausea', 'Pain', 'Pyrexia', 'Respiratory tract congestion', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 1039221,NY,76.0,M,"Pt is a 76-year old with SIDEROBLASTIC ANEMIA that had been mild and without need for treatment, and IgM MGUS. Presented to ED with newly diagnosed AML, in MDS with WBC counts ~250, 000. He had a normal (EX ANEMIA) CBC on Jan-21. He had COVID vaccine #1 on Jan-25. About 4-days later he developed diffuse dermititis and severe fatigue. He had an ED visit on Feb-8 for these issues and was prescribed Prednisone and Cefalexin (completed Feb-15). CBC was NOT done at that ED visit. He called HEME clininc on Feb-16 (see also the Hematology Note) stating that he was just NOT feeling well in general with increased fatigue and DOE. He noted that the dermatitis was mostly resolved. We rechecked CBC on Feb-17 (results available about 4-PM) that indicated ACUTE LEUKEMIA. Presents to the MC with MDS on FEB18.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/25/2021,01/29/2021,4.0,PVT,Levothyroxine,"sideroblastic anemia, BCC. Hypothyrodism, and prostatecancer, SCC","sideroblastic anemia, BCC. Hypothyrodism, and prostatecancer, SCC",,NKDA,"['Acute leukaemia', 'Acute myeloid leukaemia', 'Dermatitis', 'Dyspnoea exertional', 'Fatigue', 'Full blood count abnormal', 'Malaise', 'White blood cell count increased']",UNK,MODERNA,IM 1039222,NJ,42.0,F,"Rapid onset of obsessive compulsive behavior - rearranging of items, movement of items from one place to another, fixation on colors, fixation on color red (fire, danger), sleeplessness, confusion, irritability, jumbled memory recall Sunday 2/15 - Manic episode experiencing behavior above plus confusion, anxiety related to events. Episode required call to 911 and assistance of EMS to transport patient to the hospital emergency room for evaluation.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,02/09/2021,02/10/2021,1.0,PVT,Aripiprazole (ABILIFY) 30 MG tablet 1 daily Fluoxetine (PROZAC) 20 MG capsule 1 daily,Possible urinary tract infection - diagnosed 02/15/21 in emergency room visit,Autism Spectrum Disorder Bipolar1 disorder,,None noted.,"['Anxiety', 'Blood creatinine increased', 'Blood culture', 'Confusional state', 'Culture urine', 'Insomnia', 'Irritability', 'Lymphocyte count increased', 'Mania', 'Memory impairment', 'Obsessive-compulsive disorder', 'Pyuria', 'Urinary tract infection', 'Urine analysis abnormal', 'White blood cell count normal']",1,MODERNA,SYR 1039250,WA,93.0,M,Daughter of decedent reported that he quickly declined within 2 weeks of receiving vaccine and developed shortness of breath. Decedent received vaccine 1/30/2021 and died 2/15/2021. Only received first dose of series.,Yes,02/18/2021,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/14/2021,15.0,SEN,unknown,,dementia,,unknown,"['Death', 'Dyspnoea']",1,PFIZER\BIONTECH,IM 1039253,MN,87.0,M,"Weak, tired, not feeling well. Admitting to the hospital",Not Reported,,Not Reported,Yes,,Not Reported,,02/16/2021,02/18/2021,2.0,SEN,,,,,,"['Asthenia', 'Fatigue', 'Malaise']",2,MODERNA, 1039271,WI,90.0,M,"Gentleman received his 1st Moderna dose on Thu. 2/11 at 0849. Vaccination protocol was completed. Pt reported feeling fine, no fever, and that he had no allergies which would prevent him from getting the vaccine. Pt played cards with friends later that day 2/11, but left at 1930 (normally plays late into evening) telling his companions he didn't feel well and his neck hurt. A welfare call was completed on Sat. 2/13, and the patient was found deceased in the bathroom by his son. It appears patient fell off toilet and hit his head on the tub. Pressure ulcer present under injection site. The presumed time of death was Thur. evening.",Yes,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,PVT,,,,,,"['Death', 'Fall', 'Head injury', 'Injection site ulcer', 'Malaise', 'Neck pain']",1,MODERNA,IM 1039304,CA,73.0,M,"Resident getting rehab therapy in the facility and has a long history of Parkinson's Disease. On 01/29/21, he received the COVID vaccine on left deltoid, resident was recently hospitalized due to Pneumonia and was on antibiotic IV and was recently placed on GT feeding due to severe dysphagia from his Parkinson's disease. On 01/31/21, started having increased congestion. On 02/02/21, started having increased temperature and WBC went up >20,000 on 02/03/21, started on Vancomycin IV on 02/04/21 but was transferred to the hospital. Facility was notified today (02/18/21) that resident expired in the hospital.",Yes,02/15/2021,Not Reported,Yes,12.0,Not Reported,N,01/29/2021,02/02/2021,4.0,SEN,"Amantadine HCl Tablet 100 MG, Fluticasone Propionate Suspension 50 MCG/AC, Metoprolol Tartrate Tablet,Rotigotine Patch 24 Hour 6 MG/24HR, Magnesium Oxide Tablet 400 MG, Heparin Sodium (Porcine) Solution 5000 UNIT/ML,Aspirin EC Tablet Delaye","Parkinson's disease, S/P GT Placement, HTN, Allergic Rhinitis, Protein Calorie Malnutrition, Herpes Viral Infection, Dysphagia, S/P Pacemaker Insertion",End Stage Parkinson's Disease,,Flomax,"['Blood sodium normal', 'Blood urea increased', 'Body temperature increased', 'Death', 'Dysphagia', 'Gastrointestinal tube insertion', 'Pneumonia', 'Respiratory tract congestion', 'SARS-CoV-2 test negative', 'White blood cell count increased']",1,MODERNA,IM 1039354,MT,83.0,F,"4 hours after receiving vaccine she had dyspnea, low oxygen saturation levels. EMS called and she was transported to local hospital, then air flighted to Clinic. She was diagnosed with COVID when she was admitted.",Not Reported,,Yes,Yes,,Not Reported,U,02/17/2021,02/17/2021,0.0,PUB,,,"Cardiac issues, Diabetes",,PCN/Sulfa,"['COVID-19', 'Dyspnoea', 'Oxygen saturation decreased']",1,MODERNA,IM 1039395,MN,75.0,F,"Weakness, dizziness, elevated Blood pressure. Was sent to the ER and admitted",Not Reported,,Not Reported,Yes,,Not Reported,,02/16/2021,02/17/2021,1.0,SEN,,,,,,"['Asthenia', 'Blood pressure increased', 'Dizziness']",2,MODERNA, 1039402,,97.0,F,"Left arm and left leg weakness following administration of the vaccine. She had similar symptoms with a stroke one year ago, but MRI reveals no new acute stroke symptoms. Her symptoms had improved over the course of the last year and worsened after the COVID vaccine.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/28/2021,02/16/2021,19.0,PVT,"aspirin, plavix, pravastatin",UTI,history of stroke,,"dilaudid, atorvastatin","['Magnetic resonance imaging brain normal', 'Muscular weakness', 'Neurological symptom']",UNK,MODERNA, 1039466,CA,65.0,F,"Pt began having nonstop vomiting and diarrhea at 730am the day after vaccination, February 17th. Persisted for over 24 hours so patient came to ER. Pt found to be in a ventricular tachycardia and hypotensive. Pt pale and cool and sts ""its hard catching my breath"". Pt becoming less responsive and required emergency intervention to stabilize her heart rate and blood pressure. Pt had multiple medications, IV fluids and ultimately emergent cardioversion to stablize heart rhythm.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/16/2021,02/17/2021,1.0,OTH,None per patient,none,none,,Aspirin-hives,"['Blood magnesium', 'Cardioversion', 'Chest X-ray', 'Computerised tomogram', 'Diarrhoea', 'Dyspnoea', 'Electrocardiogram', 'Hypotension', 'Pallor', 'Ultrasound scan', 'Unresponsive to stimuli', 'Ventricular tachycardia', 'Vomiting']",1,MODERNA,IM 1039506,AL,53.0,F,Patient suffered a stroke the next day. She was hospitalized at Hospital.,Not Reported,,Not Reported,Yes,,Not Reported,Y,02/03/2021,02/04/2021,1.0,PVT,Unknown,Unknown,Unknown,,Unknown,['Cerebrovascular accident'],1,MODERNA,IM 1039520,VA,34.0,F,"Patient came back to pharmacy two days after she received the vaccine and admitted that immediately after receiving the vaccine, her heart was racing and she was having feelings of swollen throat and tongue. However, at the time, she did not say anything and went home after 30 minutes of observation. After the vaccine, her arm was first sore and a couple of days later, the soreness turned into an itching. The itch is local around injection site on left arm. Potential allergic reaction, lasting for days post injection.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/16/2021,02/16/2021,0.0,PHM,none,,HepC and others unknown,,Clindamycin,"['Immediate post-injection reaction', 'Injection site pruritus', 'Pain in extremity', 'Palpitations', 'Pharyngeal swelling', 'Swollen tongue']",1,MODERNA,IM 1039597,,64.0,M,"Death Narrative: Patient received first dose of COVID vaccine on 1/30/21. Reported by his wife to agency that he passed away at an outside hospital on 2/14/21. By report of his wife: ""due to sepsis (related to bed sores) and aspiration pneumonia""",Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/14/2021,15.0,OTH,,,,,,"['Death', 'Decubitus ulcer', 'Pneumonia aspiration', 'Sepsis']",1,PFIZER\BIONTECH,IM 1039881,FL,71.0,F,"Angioedema; A spontaneous report was received from a physician concerning a 71-years-old, female patient who received Moderna's COVID-19 Vaccine and who experienced angioedema of lip, mostly upper, part of lower, and into cheeks. The patient's medical history included angioedema. Concomitant product use was not provided by the reporter. On 13 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 039K20A) intramuscularly for prophylaxis of COVID-19 infection. On 19 Jan 2021, the patient woke up with angioedema of the lip, mostly upper, part of lower, and it went into cheeks. Patient reported the same thing happened to her a fewyears ago with no known cause. Treatment for the event included a shot of prednisone and oral prednisone. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event angioedema of lip, mostly upper, part of lower and into cheeks was unknown.; Reporter's Comments: This case concerns a 71-year-old female patient with a significant medical history of angioedema, who experienced a serious unexpected event of angioedema. The event occurred approximately 6 days after first dose of mRNA-1273, lot # 039K20A. Treatment for the event included a shot of prednisone and oral prednisone. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. However, patient's prior medical history of angioedema may have been contributory.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/19/2021,6.0,UNK,,,Medical History/Concurrent Conditions: Angioedema,,,['Angioedema'],1,MODERNA,OT 1039884,TX,67.0,F,"Lost control of bladder; Could not walk; Paralyzed from the waist down for about 24 hours; Received the 2nd dose on 22Jan; Diarrhea; Vomiting; A spontaneous report was received from a consumer, concerning a 67-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced paralyzed from the waist down for about 24 hours/PT: Paralysis, received the 2nd dose on 22 Jan 2021/PT: inappropriate schedule of product administration, lost control of bladder/PT: urinary incontinence, could not walk/PT: gait inability, diarrhea/PT: diarrhoea, and vomiting/PT: vomiting. The patient's medical history was not provided. Concomitant medications included omeprazole, fluoxetine hydrochloride, propranolol, colestipol, acetylsalicylic acid, and calcium. The patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) on 28 Dec 2020. On 22 Jan 2021, the same day as the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, following the second vaccination, the patient experienced vomiting and diarrhea. On 23 Jan 2021, the patient could not walk, was paralyzed from the waist down for about 24 hours, and lost control of her bladder. Treatment information for the events was not provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events was not applicable. The outcome of the event, paralyzed from the waist down, was considered recovered/resolved on 24 Jan 2021. The outcome of the event, received second dose on 22 Jan 2021, was considered resolved on 22 Jan 2021. The outcome of the events, vomiting, diarrhea, could not walk, and lost control of bladder, was unknown.; Reporter's Comments: This case concerns a 67 year old female subject, who experienced a serious unexpected event of paralysis after second dose of mRNA1273 (Lot# 032L20A). Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/22/2021,25.0,UNK,ZEGERID [OMEPRAZOLE]; PROZAC; PROPRANOLOL; COLESTIPOL; BABY ASPIRIN; CALCIUM,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Diarrhoea', 'Gait inability', 'Inappropriate schedule of product administration', 'Paralysis', 'Urinary incontinence', 'Vomiting']",2,MODERNA,OT 1039885,NY,42.0,M,"Face was paralyzed; A spontaneous report was received from a consumer concerning a 42-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced facial paralysis. The patient's medical history was not reported. Concomitant medication history was not provided. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient woke up to find that his face was paralyzed. The patient went to the urgent care center and they referred him to the emergency department at the hospital. After numerous tests they diagnosed him with Bell's Palsy. Treatment for this event included prednisone and doxycycline. Action taken with mRNA-1273 in response to this event was not reported. The outcome for the event, facial paralysis, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/27/2021,29.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Facial paralysis'],2,MODERNA,OT 1039886,NY,68.0,F,"Showing signs of hyperthyroidism; A spontaneous report was received from a consumer concerning a 68-year-old, female patient who received Moderna's COVID-19 vaccine and developed signs of hyperthyroidism. The patient's medical history was hypothyroidism. No relevant concomitant medications were reported. On 06 Jan 2021, patient received their first of two planned doses of mRNA-1273 (Batch number 026L20A) injection for the prophylaxis of COVID-19 infection. On 02 Feb 2021, within 28 days of receiving vaccine, patient had a six-month checkup that showed signs of hyperthyroidism when patient has history of hypothyroidism. The patient's healthcare professional consent was obtained. Treatment for the event was not provided. Action taken with the event was not reported. The outcome of the event, signs of hyperthyroidism, was considered ongoing.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. However, the patient's history of hypothyroidism may confound causality assessment. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,02/02/2021,27.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Hyperthyroidism'],1,MODERNA, 1039887,MA,22.0,F,"Anaphylactic reaction; Burning sensation in eyeballs; Wheezing; Rales; Airways were closing; Can't breathe; A spontaneous report was received from a consumer concerning a 22-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction, burning sensation in eyeballs/abnormal sensation in eye, wheezing, rales, airways were closing/obstructive airways disorder, and can't breathe/dyspnoea. The patient's medical history was not provided. No relevant concomitant medications were reported. On 05 Feb 2021, within 5 minutes prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 05 Feb 2021, within 5 minutes after receiving her second dose of vaccine, the patient reported a burning sensation in her eyeballs, followed by wheezing and rales in her lungs. She was given epinephrine and taken to the emergency room via an ambulance. She was given a second dose of epinephrine. Her airways were closing and she could not breathe. She was given a steroid, diphenhydramine, H2 antagonist and albuterol. Consent given for follow up calls. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events, anaphylactic reaction, burning sensation in eyeballs, wheezing, rales, airways were closing, and can't breathe, was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Abnormal sensation in eye', 'Anaphylactic reaction', 'Dyspnoea', 'Obstructive airways disorder', 'Rales', 'Wheezing']",2,MODERNA,OT 1039896,MI,29.0,F,"hemifacial spasms on the right side of face; weird sound in the ear; pulsating in the neck; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 29-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the left arm on 30Dec2020 10:00 (lot number and expiry date unknown) at single dose for Covid-19 immunization in a workplace clinic. Medical history included hidradenitis suppurativa. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included unspecified other medication. The patient received first dose of hepatitis vaccine in the left arm on 15Dec2020 (29 years old) for immunization which was within 4 weeks prior to the COVID vaccine. On 07Jan2021 07:15, the patient experienced hemifacial spasms on the right side of face. The right side of face tightens to the point her eye closes, mouth pulls up and cheeks pulls up as well along with a weird sound in the ear and pulsating in the neck. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included CT scan: unknown results in Jan2021. The patient has not been tested for COVID-19 since the vaccination. The patient received treatment of muscle relaxer, medrol dose pack. The outcome of the events was not recovered. The reporter considered the events serious as disabling/incapacitating but did not results in death, not life threatening, did not cause/prolong hospitalization, no congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the hemifacial spasms and other reported events due to temporal relationship Additional information is needed to better assess the case, including complete medical history, diagnostics including results of Head CT scan, EMG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/30/2020,01/07/2021,8.0,WRK,,,Medical History/Concurrent Conditions: Hidradenitis suppurativa,,,"['Computerised tomogram', 'Facial spasm', 'Sensation of blood flow', 'Tinnitus']",1,PFIZER\BIONTECH,OT 1039900,MA,85.0,M,"groin started to hurt; tired; This is a spontaneous report from a contactable consumer. A 85-years-old male patient (reporter's grandfather) received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Batch/lot number: EL9262, via an unspecified route of administration in right arm, on 01Feb2021 (at 85 years of age) at single dose for COVID-19 immunization. Medical history included diabetes from an unknown date. There were no concomitant medications. On 01Feb2021 the patient felt great; on 02Feb2021 he felt ok but was tired; on 03Feb2021 his groin started to hurt, it hurt even to touch it, his leg started to bother him from his groin down and then was unable to be touched; the reporter asked if that could be swollen lymph nodes from the vaccine. At 3 o'clock the patient rushed to the hospital and, on 04Feb2021, he was admitted to hospital due to pain in groin. They thought he had broken something but that was ruled out. The patient underwent an X-ray of his leg and labs. He does not have any infection. At the time of the report the patient was still in hospital and the events ""groin started to hurt"" had not resolved yet and outcome of the event ""tired"" was unknown.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/01/2021,02/02/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Diabetes (Verbatim: Diabetes),,,"['Fatigue', 'Groin pain', 'Investigation', 'X-ray']",1,PFIZER\BIONTECH, 1039901,WV,42.0,F,"smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had been/pain was in her scapula, her left arm, all of her joints; pain was in her scapula, her left arm, all of her joints; could feel her blood surging through her body; she couldn't get comfortable; Crying; Allergic reaction; body aches; dizziness; hallucinations; up all night; exhausted/ fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9261), via an unspecified route of administration at the right arm on 22Jan2021 14:58 at a single dose for COVID-19 vaccination and ketorolac tromethamine (TORADOL), via an unspecified route of administration on 22Jan2021 16:30 at an unknown dose, single for pain. The patient medical history includes low iron anemia from Oct2020 and allergy to eggs, pecans, walnuts and latex. Also on 15Jan2021, she fell down the stairs and thought she broke her arm and was in severe pain. The has been taking iron supplements as concomitant medications. The patient reported having hallucinations, body aches, fatigue and dizziness on Jan2021. On 22Jan2021 09:00PM, she started smelling smoke, like cigarette smoke, like her home was filling with cigarette smoke, and no one in her house even smokes. On 22Jan2021, she also had severe stomach cramps like she was going to have diarrhea, but she never did. She says she was bowed over with the worst cramps like menstrual cramps, and her left arm was in pain, more pain that it had been. She says she could feel blood surging in her legs, it was almost surreal, she could feel the blood going through her body, which she never had felt something like that before. She says that the pain was in her scapula, her left arm, all of her joints. She says she could not get comfortable, and she was crying she was in that much pain. She says she does not typically cry and has a pretty good pain tolerance. She says she was getting freaked about that, and the next morning she was exhausted (Jan2021), she would assume since she was up all night in pain (Jan2021). The following day she laid around and felt extremely fatigued and dizzy, then by Sunday she was feeling better. For pain treatment she took Ibuprofen though her doctor also prescribed her another pain pill for her arm, she was scared to take it, so she took Ibuprofen 600mg which was also prescribed to her. The patient said that she did not think it was an allergic reaction but her doctor thought it might have been. The action taken in response to the events for ketorolac tromethamine was unknown. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/01/2021,,UNK,TORADOL,,Medical History/Concurrent Conditions: Allergy to nuts; Anemia; Arm fracture; Egg allergy; Fall; Latex allergy; Pain,,,"['Abdominal pain upper', 'Arthralgia', 'Crying', 'Discomfort', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Hallucination', 'Hypersensitivity', 'Insomnia', 'Pain', 'Pain in extremity', 'Parosmia', 'X-ray']",UNK,UNKNOWN MANUFACTURER, 1039902,,,F,"feeling flushed and faint; her blood pressure went up as well as her heart rate; her blood pressure went up as well as her heart rate; brain fog; slurring her words; lethargy/ lethargic for 2-3 hours; hands were so cold it was like they were stuck in a snow bank and wasn't able to get them warm; feeling flushed and faint; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on unspecified date as a SINGLE DOSE for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The consumer reported her daughter had a bad reaction and is concerned about getting the second dose since it is said people could have more severe reactions. The patient's heart rate was up, blood pressure was up, feeling flushed and faint. Since her daughter works at the hospital and was next to the emergency room they kept an eye on her and everything. When she was okay to go back to her department she had brain fog, lethargy/ lethargic for 2-3 hours, and slurring of her words and that lasted 2-3 more hours. A few days later her hands were so cold it was like they were stuck in a snow bank and she wasn't able to get them warm. Not sure if that was a late reaction since it has never happened before. The patient underwent lab tests and procedures which included blood pressure: blood pressure was up on unknown date, heart rate: heart rate was up on unknown date. Outcome of the feeling flushed and faint, her blood pressure went up as well as her heart rate, brain fog, slurring her words, lethargy/ lethargic for 2-3 hours were unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Blood pressure increased', 'Blood pressure measurement', 'Dizziness', 'Dysarthria', 'Feeling abnormal', 'Flushing', 'Heart rate', 'Heart rate increased', 'Lethargy', 'Peripheral coldness']",1,PFIZER\BIONTECH, 1039905,CT,87.0,M,"a possible transient ischaemic attack; the patient began retaining water; This is a spontaneous report from a non-contactable consumer (patient). An 87-year-old male patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 19Jan2021 for Covid-19 immunisation. Medical history included mitral valve replacement, pacemaker. The patient had not experienced Covid-19 prior vaccination. Concomitant medication included blood thinner, atorvastatin calcium (STATIN), lisinopril (manufacturer unknown), warfarin (manufacturer unknown). No other vaccine received in four weeks. In 2021 a few days after 1st vaccination the patient began retaining water. On 04Feb2021 the patient was hospitalized for a possible transient ischemic attack. The patient was hospitalized for a possible transient ischaemic attack and began retaining water from 04Feb2021 to an unknown date. Therapeutic measures were taken as a result of events. The outcome of unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/19/2021,02/04/2021,16.0,UNK,STATIN [ATORVASTATIN CALCIUM]; LISINOPRIL; WARFARIN,,Medical History/Concurrent Conditions: Artificial cardiac pacemaker user (pacemaker); Mitral valve replacement,,,"['Fluid retention', 'Transient ischaemic attack']",1,PFIZER\BIONTECH, 1039906,,38.0,M,"systematic allergic reaction that is still on going; Exactly two weeks after taking the first shot my body broke out in systematic rash; welts with swelling of face.; welts with swelling of face.; This is a spontaneous report from a contactable Other HCP (patient himself). A 38-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EH9899, expiration date not reported) intramuscular on left arm on 28Dec2020 at a single dose, then second dose (lot no. EK9231, expiry date not reported), intramuscular on right arm on 18Jan2021 at a single dose for covid-19 immunization. Medical history included known allergies: penicillin. (no major history of allergic reactions except penicillin as a baby). The patient's concomitant medications were not reported. The patient reported that on 11Jan2021 15:00 (03:00 PM) ""exactly two weeks after taking the first shot, my body broke out in systematic rash and welts with swelling of face. My doctor thought two weeks was two long of a delay for the reaction to be from the vaccine. My doctor thought it might have been some antibiotics I had been on and they gave me prednisone. The prednisone cleared up the reaction before the second shot. I received the second shot (on 18Jan2021 with lot no. EK9231, intramuscular on right arm) and within two hours I had an even worse systematic allergic reaction that is still on going as of today 04Feb2021. The Prednisone is not clearing up the reaction. I am going to have to take short term disability."" The adverse events resulted to patient had clinic visit, disability or permanent damage. Patient took prednisone, famotidine, hydroxyzine, and XANAX (because of the prednisone) as treatments. The vaccine was given in the hospital. No other vaccines were given in four weeks. Outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported allergic reaction manifested with ""systematic rash and welts with swelling of face"" and the administration of the COVID-19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/11/2021,14.0,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy (known allergies: penicillin),,,"['Hypersensitivity', 'Rash', 'Swelling face', 'Urticaria']",1,PFIZER\BIONTECH,OT 1039907,TN,,F,"red to blue rash on thigh; short of breath; headache; could hardly walk; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable 75-year-old female consumer (Patient) received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME) (lot number/expiration date: unknown), via unknown route of administration, on 25Jan2021 as a single dose for COVID-19 immunization. Relevant medical history was unknown. Concomitant medications was unknown. On 26Jan2021 patient was admitted to hospital for red to blue rash on thigh and short of breath. She stated she got headache after injection and 2 hrs later she could hardly walk. She was in the hospital for 3 days. Complete cardiac work up and CT scans performed which were all negative. The patient inquired if she should take the second covax. The outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/25/2021,01/01/2021,,UNK,,,,,,"['Computerised tomogram', 'Dyspnoea', 'Gait disturbance', 'Headache', 'Investigation', 'Rash']",1,PFIZER\BIONTECH, 1039908,MA,53.0,F,"Syncope; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the right arm on 15Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included Crohns disease which is in remission (No immunosuppressants in 5 years) and shellfish sensitivity. The patient is not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), trazodone, buspirone hydrochloride (BUSPAR), lisdexamfetamine mesilate (VYVANSE) and methylfolate. The patient experienced syncope on 15Jan2021. The event was assessed as serious (medically significant). The outcome of the event was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,PVT,CYMBALTA; TRAZODONE; BUSPAR; VYVANSE; METHYLFOLATE,,Medical History/Concurrent Conditions: Disease Crohns (Crohns Disease which is in remission. No immunosuppressants in 5 years); Shellfish allergy (Shellfish sensitivity),,,['Syncope'],1,PFIZER\BIONTECH, 1039911,VA,61.0,F,"one of vials was accidentally diluted with 2mL of diluent. Instead of 1.8mL; one of vials was accidentally diluted with 2mL of diluent/2 people were vaccinated with it; one of vials was accidentally diluted with 2mL of diluent/2 people were vaccinated with it/received vaccine that was diluted with 2mL instead of 1.8mL; This is a spontaneous report from a contactable pharmacist reported similar events for 2 patients. This is 1st of 2 reports. This Pharmacist reported for a 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported NDC number of COVID-19 Vaccine: 59267100001) , via an unspecified route of administration on 03Feb2021 at a single dose (diluted the COVID-19 vaccine with 2mL instead of 1.8mL) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her first dose of BNT162B2 intramuscular (hopefully it was in the arm) as covid-19 immunization. On 03Feb2021, one of vials was accidentally diluted with 2mL of diluent. Instead of 1.8mL, he used a whole 2mL. 2 people were vaccinated with it. Patients received vaccine that was diluted with 2mL instead of 1.8mL. The caller explained she was calling because one of her pharmacists diluted the COVID-19 vaccine with 2mL instead of 1.8mL. The pharmacist did inject two patients and it was their second dose. Caller is calling because she wants to know what the next steps are with the patients. Should they get another dose or what? Prior vaccinations were reported as unknown. The vaccine was given in a Pharmacy. Information on the lot/batch number has been requested.; Sender's Comments: The company deems there is not a reasonable possibility that the reported event is related to suspect product BNT162b2. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021126750 same drug/reporter, different patient/AE",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/03/2021,0.0,PHM,,,,,,"['Incorrect dose administered', 'Overdose', 'Product preparation issue']",2,PFIZER\BIONTECH, 1039912,,,F,"breathing difficulties; Ejection fraction down to 19 percent and fluid in lungs.; achy; chills; unresponsive; fluid in lungs; Heart is weak/Will be removed fluid from heart; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer Sales Representative. An 8-decade-old (in her 70s) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included surgeries, congestive heart failure (CHF) and cardiac issues (many previous heart issues). Concomitant medications included multiple medications including blood thinners. On the night 1 and day 2, the patient experienced achy and some chills. On night 3, the patient was unresponsive with breathing difficulties. Ejection fraction down to 19 percent and had fluid in lungs. Heart was weak. Intubated and catheter placed. Patient was in cardiac ICU. Responding with hand movements. Would be removed fluid from heart and lungs. The above mentioned events took place after use of product, and required hospitalization. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Cardiac disorder (many previous heart issues); Congestive heart failure; Surgery (surgeries),,,"['Cardiac disorder', 'Chills', 'Dyspnoea', 'Ejection fraction', 'Ejection fraction decreased', 'Pain', 'Pulmonary oedema', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH, 1039914,PA,40.0,F,"tired; headache; faint; vomit; This is a spontaneous report from a contactable consumer reported for herself. A 40-year-old female received the first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via intramuscular on 04Feb2021 18:00 into left arm at a single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID 19. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT). On 05Feb2021 5:30, the patient experienced faint and vomit and on 16: 00, more vomit, tired and headache all day. No treatment received for the events. Since the vaccination, the patient has not tested for COVID 19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,OTH,ZOLOFT,,,,,"['Fatigue', 'Headache', 'Syncope', 'Vomiting']",1,PFIZER\BIONTECH, 1039915,PA,69.0,F,"shortness of breath; Tested positive; Tested positive; This is a spontaneous report from a contactable consumer. A 69-year-old female patient started to receive BNT162B2 (Pfizer product, lot number was EL3248, expiration date was unknown) via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant. Patient had no COVID prior vaccination. The patient had COVID test post vaccination and tested positive on 26Jan2021. Patient developed shortness of breath oxygen levels keep dropping on 03Feb2021. The events resulted in Emergency room/department or urgent care and hospitalization. It was unknown if patient received treatment for events. The outcome of events was unknown.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/12/2021,01/26/2021,14.0,PVT,,,,,,"['COVID-19', 'Drug ineffective', 'Dyspnoea', 'Oxygen saturation', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1039917,PA,52.0,F,"Enlargened lymph node in mouth; headache in temples; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: E13302) solution for injection, via an unspecified route of administration in left arm on 11Jan2021 13:00 at a single dose for Covid-19 immunization. Medical history included lower back pain. Concomitant medications: patient received medications two weeks prior to vaccination. The patient had the first dose of the vaccine on 22Dec2020 at 1pm (lot/batch number: El0140) in left arm. Patient reported that after 2 days (13Jan2021), at around 3pm she got a headache in her temples that would not go away. She went to the urgent care Covid test done which was negative. Had ER visit for headache then with continued headache, then 2 weeks later another ER visit. She also had enlarged lymph node in mouth that was found 2 days ago (03Feb2021). Patient visited ER for the events. As treatment, patient was given Rocephin IV, migraine cocktail, morphine and Dilad. The patient underwent lab tests which included Nasal swab: negative on 16Jan2021 (Rapid test). Prior to vaccination, patient was not diagnosed with Covid-19. Outcome of the events was not recovered. No follow-up activities are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/13/2021,2.0,PVT,,,Medical History/Concurrent Conditions: Low back pain,,,"['Headache', 'Lymphadenopathy', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1039919,LA,75.0,M,"headache; feeling tired; feeling weak; having breathing problems/couldn't catch my breath; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: 813249 (reported as ""Pfizer 813249"")), via an unspecified route of administration on 28Jan2021 08:30 at a single dose for covid-19 immunization at a hospital. The patient's medical history was not reported. The patient has no allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received other medications within 2 weeks of vaccination (unspecified). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: ek9231), in the right upper arm on 07Jan2021 for COVID-19 immunization. The following day2 (2021), the patient experienced headache and feeling tired. The 3rd day after, patient was more tired and feeling weak and began having breathing problems. Day 4, more severe breathing problems noted. Day 5, the patient woke up and couldn't catch his breath. The patient went to the ER. The patient had numerous tests and was given breathing treatments, O2, and ""Anit bo"". The patient was tested for covid post vaccination via nasal swab which was negative. The outcome if the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,,,PVT,,,,,,"['Asthenia', 'Dyspnoea', 'Fatigue', 'Headache', 'Laboratory test', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1039921,MO,39.0,F,"pain in the left scapula area; a sensation of her body ""vibrating"" down the left arm; I felt: hot, a water dripping sensation inside my left arm; elevated BP; elevated pulse; elevated respirations; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686), via an unspecified route of administration on 18Jan2021 09:00 in left arm, at single dose for covid-19 immunization. Medical history included known allergies: Latex and causes a rash. Concomitant drugs included women's 1 a day multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Immediately after administration of the Covid-19 Vaccine on 18Jan2021, the patient felt: hot, a water dripping sensation inside my left arm, elevated BP, elevated pulse, and elevated respirations. On 22Jan2021 02:00 the first morning she noticed pain in the left scapula area, and a sensation of her body ""vibrating"" down the left arm. Each day the ""vibrations"" have worsened from 1 arm, to both arms, to up and down her spine, to up her neck, and some days even her face. She got NO relief from the ""vibrations"". They are constant 24 hours a day. She had been to the chiropractor, urgent care, and the ER. She had physician consults, blood work, x-rays, and CT Scan. It is effecting her life. She had NO relief, and got answers that she just had anxiety. This is not just anxiety. There is something wrong with her, and the only change in her life, has been to receive her covid vaccine. Medications have been given to help mask the symptoms, but they are still present, and are never changing or ending. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and considered as disability condition. No treatment was received for events (except event a sensation of her body ""vibrating"" down the left arm) The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/18/2021,01/18/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Latex allergy (known allergies: Latex- causes a rash); Rash (known allergies: Latex- causes a rash),,,"['Back pain', 'Blood pressure increased', 'Blood pressure measurement', 'Computerised tomogram', 'Feeling hot', 'Heart rate', 'Heart rate increased', 'Investigation', 'Paraesthesia', 'Respiratory rate', 'Respiratory rate increased', 'X-ray']",1,PFIZER\BIONTECH, 1039922,,73.0,F,"death was from natural causes; collapsed; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Feb2021 at 73-years-old at a single dose for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing (on oxygen as needed, but not every day), oxygen therapy from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) for immunization on unknown dates (Gets flu shot every year around October). On 06Feb2021, the patient collapsed (medically significant) and experienced death was from natural causes (death, medically significant). The clinical course was reported as follows: The reporter stated that his grandmother received the first dose of the Pfizer COVID-19 vaccine on 05Feb2021 and passed away on the morning of 06Feb2021. The patient went to bed and woke up in the middle of the night around 03:00 to use the bathroom and collapsed and died within 10-15 minutes of collapsing. The patient was pronounced dead at the scene. The reporter asked: ""What do you know about the news in the media about reports of death in nursing home elderly patients?"" The reporter wanted to know the ingredients of the Pfizer COVID-19 vaccine. The reporter wanted to know about the use of the Pfizer COVID-19 vaccine in patients with underlying conditions. The patient had COPD and was on oxygen as needed, but not every day. The Medical examiner said the death was from natural causes and the family was not doing an autopsy. The patient had been tested for COVID and was negative. The patient underwent lab tests and procedures which COVID test: negative on an unspecified date. The clinical outcome of the event, death was from natural causes, was fatal. The clinical outcome of the event, collapsed, was unknown. The patient died on 06Feb2021 due to death was from natural causes. An autopsy was not performed. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.; Reported Cause(s) of Death: death was from natural causes",Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,UNK,,,"Medical History/Concurrent Conditions: COPD (on oxygen as needed, but not every day); Oxygen therapy",,,"['Death', 'Fall', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1039923,NC,66.0,M,"left sided facial droop consistent with Bell's palsy; This is a spontaneous report from a contactable Physician. A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), intramuscularly on 22Jan2021 at single dose for COVID-19 immunization. Medical history included acral lentiginous melanoma (ALM), myelodysplastic syndrome (MDS), hypertension (HTN), atrial fibrillation, left sided facial and ear pain. The patient's concomitant medications were not reported. The patient previously took codeine and experienced drug allergy. It was reported that the patient was evaluated in the emergency department on 06Feb2021 for left sided facial droop consistent with Bell's palsy which started from 06Feb2021. The patient was complaining of left sided facial and ear pain for several weeks prior to vaccination and development of Bell's palsy. The reported event Bell's palsy resulted in Emergency room/department or urgent care. Therapeutic measures Valtrex, prednisone were taken as a result of the reported event Bell's palsy. The outcome of the event Bell's palsy was unknown. Information on Lot/Batch has been requested.; Sender's Comments: Event represents an intercurrent medical condition and unrelated to BNT162B2. The patient experienced left sided facial and ear pain before receiving vaccination. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,02/06/2021,15.0,PVT,,,Medical History/Concurrent Conditions: Acral lentiginous melanoma; Atrial fibrillation; Ear pain; Facial pain; Hypertension; MDS,,,['Facial paralysis'],1,PFIZER\BIONTECH,OT 1039924,NY,83.0,F,"respiratory distress; covid test result: Positive; This is a spontaneous report from a contactable consumer. An 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 19:00 at single dose for covid-19 immunisation. The patient medical history was not reported. No other vaccine in four weeks. There were other medications in two weeks. No COVID prior vaccination. No Known allergies. The patient experienced respiratory distress on 09Jan2021 12:00. Patient was taken to hospital then released week later and currently readmitted with respiratory distress. Treatment received for the events. Nasal Swab Covid test post vaccination on 11Jan2021: result Positive. Outcome of events as not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/07/2021,01/09/2021,2.0,SEN,,,,,,"['Respiratory distress', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1039925,IL,45.0,M,"fainted; nausea; left arm began to tingle; dizziness; Broke out in a cold sweat; chills; Lost control of my bladder.; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL6269), via an unspecified route of administration in Left arm on 04Feb2021 15:00 (at the age of 45-years-old) at SINGLE DOSE for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. 51 hours after receiving the vaccine, the patient was sitting down watching a film. His left arm began to tingle, and he felt a wave of dizziness and nausea come over him. He stood up, walked a few steps and sat back down. He broke out in a cold sweat, chills, and saw stars. He leaned forward with his head in his hands, and apparently fainted for a moment and lost control of his bladder. All events started on 06Feb2021 06:00 PM. No treatment received for the events. The outcome of the events was recovered in Feb2021. No covid prior vaccination, no Covid tested post vaccination, no known allergies.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/06/2021,2.0,PHM,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Cold sweat', 'Dizziness', 'Nausea', 'Paraesthesia', 'Syncope', 'Urinary incontinence']",1,PFIZER\BIONTECH, 1039926,IN,45.0,F,"Nearly passed out; Postural Orthostatic Tachycardia Syndrome; icy like pulsation through my blood occurred; fell to the ground; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (not pregnant) received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), Lot number: EL9261, via an unspecified route of administration on 06Feb2021 12:30 at single dose in Left arm for covid-19 immunisation. Facility type Vaccine was Hospital. Medical history included anaemia, no known allergies. Patient had COVID-19 starting on 06Jan2021 and persisting through 16Jan. Her COVID symptoms were crushing chest pain, no fever, blood oxygen level never dropped below 98%. The patient's concomitant medications were not reported. There were no other vaccine in four weeks. Patient was experiencing Postural Orthostatic Tachycardia Syndrome. Nearly passed out going to the toilet when she first awoke. An icy like pulsation through her blood occurred first thing this AM, day after the vaccine. She fell to the ground and called for her husband to help her. He gave her 500mg acetaminophen and aspirin. She slept. Same thing happened with pulse 140+, he measured, as she showered. They stopped the shower, she laid down and recovered. When she got up immediately the pulse rises to 120+. Adverse events started from 07Feb2021 08:30 AM. Therapeutic measures were taken in response to the events. The outcome of the events was not recovered. Covid was not tested post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/07/2021,1.0,PVT,,,"Medical History/Concurrent Conditions: Anemia; COVID-19 (COVID symptoms were crushing chest pain, no fever, blood oxygen level never dropped below 98%.)",,,"['Chills', 'Fall', 'Heart rate', 'Postural orthostatic tachycardia syndrome', 'Presyncope']",1,PFIZER\BIONTECH, 1039927,CA,71.0,F,"passed out; passed out when went into bathroom at 5 am, cut chin when fell; dehydrated; sweats; chills-shivers; Bad headache; Dizziness; Couldn't sleep; Neuropathy pain in hip/groin; This is a spontaneous report from a contactable consumer reporting for herself. A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EM9809 and expiry date unknown) on 05Feb2021 08:30 at single does via an unspecified route of administration into her left arm for COVID-19 immunization. Medical history included known allergies to statins. The patient had received first dose of BNT162B2 (lot number EL3248) on 15Jan2021 16:00 for COVID-19 immunization (vaccine location=Left arm). The patient had not had COVID prior the vaccination, COVID not tested post the vaccination. Concomitant medication included gabapentin (GABAPENTIN), fish oil (FISH OIL), zinc (ZINC), cyanocobalamin (VITAMIN B 12), iron (IRON). No other vaccine received in four weeks. The patient experienced adverse events from 05Feb2021 at 20:30. She experienced chills-shivers, had bad head ache, dizziness, couldn't sleep, intense neuropathy pain in hip/groin when got out of bed and then passed out when went into bathroom at 5 am (06Feb2021), cut chin when fell. She felt dehydrated. Cold marble floor felt good as she had sweats, so she just layed there awhile. Her husband came to her rescue with water and cold compress for her head. She received lots of liquids and rest. She had good night's sleep on 06Feb2021. The outcome of the events was reported on 07Feb2021 as recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,GABAPENTIN; FISH OIL; ZINC; VITAMIN B 12 [CYANOCOBALAMIN]; IRON,,Medical History/Concurrent Conditions: Drug allergy (Drug Allergy: statins),,,"['Chills', 'Dehydration', 'Dizziness', 'Fall', 'Headache', 'Hyperhidrosis', 'Insomnia', 'Loss of consciousness', 'Neuralgia']",2,PFIZER\BIONTECH, 1039928,TX,73.0,M,"Moderate diarrhea with dark red blood in stool on day 3; Moderate diarrhea with dark red blood in stool on day 3; This is a spontaneous report from a contactable consumer (patient). A 73-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Left arm on 04Feb2021 08:30 (at the age of 73-years-old) at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient experienced moderate diarrhea with dark red blood in stool on day 3 on 07Feb2021 08:00. No treatment received for the events. No COVID prior vaccination, no COVID tested post vaccination. The outcome of the events was not recovered. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/07/2021,3.0,UNK,,,,,,"['Diarrhoea', 'Haematochezia']",1,PFIZER\BIONTECH, 1039929,NY,59.0,M,"Chest pain; shortness of breath; pain radiating down left arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 06Feb2021 12:00 at single dose in left arm for COVID-19 immunisation. Medical history included allergies to iodinated contrast, chronic lymphocytic leukaemia (CLL), herniated discs. The patient didn't have COVID prior vaccination. Concomitant medications included tamsulosin hydrochloride (FLOMAX), sertraline hydrochloride (ZOLOFT), valacyclovir, ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER). The patient previously received the first dose of bnt162b2 on 16Jan2021 02:00 PM in left arm for COVID-19 immunisation. There were no other vaccine in four weeks. The patient experienced chest pain, shortness of breath, pain radiating down left arm. Adverse events start from 07Feb2021 05:45 AM. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and hospitalization for 1 day. Treatment was received for the events. The patient underwent lab test which included Blood tests, EKG on unknown date. The outcome of the events was recovering. COVID was not tested post vaccination. Information on Lot/Batch has been requested.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/06/2021,02/07/2021,1.0,UNK,FLOMAX [TAMSULOSIN HYDROCHLORIDE]; ZOLOFT; VALACYCLOVIR [VALACICLOVIR]; CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;,,Medical History/Concurrent Conditions: CLL; Herniated disc; Iodine allergy,,,"['Blood test', 'Chest pain', 'Dyspnoea', 'Electrocardiogram', 'Pain in extremity']",2,PFIZER\BIONTECH, 1039930,MO,69.0,F,"Sore arm; neck pain; radiated to shoulder; radiated to back toward backbone, then up back; headache; This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL9263 and expiry date unknown) on 26Jan2021 18:00 at single does via an unspecified route of administration into her left arm for COVID-19 immunization. Medical history included Lupus, Lyme disease, hypothyroid, Meniere's, and sulfa allergies. The patient had not had COVID prior the vaccination, COVID not tested post the vaccination. Concomitant medication included levothyroxine (LEVOTHYROXINE), acyclovir (ACYCLOVIR), ezetimibe (EZETIMIBE), hydroxychloroquine (HYDROXYCHLOROQUINE). No other vaccine received in four weeks. The patient experienced adverse events from 20:00 on 26Jan2021. She experienced sore arm, radiated to shoulder, then to back toward backbone, then up back and side of neck. It's very painful. On 07Feb2021 (""today""), her neck pain was better but she had a headache. These events took place ongoing for several days after and since she had the vaccine. It was reported that the events resulted in Disability or permanent damage. The patient did not receive treatment for the events. The outcome of the events was provided as recovering.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/26/2021,01/26/2021,0.0,PVT,LEVOTHYROXINE; ACYCLOVIR [ACICLOVIR]; EZETIMIBE; HYDROXYCHLOROQUINE,,Medical History/Concurrent Conditions: Hypothyroidism; Lupus-like syndrome; Lyme disease; Meniere's disease; Sulfonamide allergy,,,"['Arthralgia', 'Back pain', 'Headache', 'Neck pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 1039932,CA,84.0,F,"unable to get up, stand or walk; unable to get up, stand or walk; This is a spontaneous report from a contactable non-healthcare professional reporting for a patient. An 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EN5318 and expiry date unknown) on 06Feb2021 13:30 at single does via an unspecified route of administration into her right arm for COVID-19 immunization. Medical history included asthma, chronic obstructive pulmonary disease (COPD), osteoarthritis, marginal zone lymphoma (stable not treated at this time), prior ductal carcinoma in situ (DCIS). Known allergies: Sulfa Drugs, Macrobid. The patient had not had COVID prior to the vaccination, COVID not tested post the vaccination. Concomitant medications in two weeks: fluticasone propionate/salmeterol xinafoate (ADVAIR), ipratropium bromide/salbutamol sulfate (COMBIVENT), losartan (LOSARTAN), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), meloxicam (MELOXICAM), tamoxifen (TAMOXIFEN), acetylsalicylic acid (ASPIRIN) low dose, ascorbic acid/biotin/ calcium/calcium phosphate dibasic/chromic chloride/cupric oxide/cyanocobalamin/ferrous fumarate/folic acid/magnesium oxide/manganese sulfate/nickel sulfate/nicotinamide/pantothenic acid/ phytomenadione/ potassium chloride/potassium iodide/pyridoxine hydrochloride/retinol/riboflavin/sodium metasilicate/sodium molybdate/ sodium selenate/hiamine mononitrate/ tocopheryl acetate/vitamin d nos/zinc oxide (CENTRUM SILVER), ascorbic acid (VITAMIN C). No other vaccine received in four weeks. On 06Feb2021 at 19:00, approximately 5.5 hours after the vaccination, the patient sat down and was unable to get up, stand or walk, was leaning to side in chair, which lasted for at least 1.5 - 2 hours. The events resulted in emergency room/department or urgent care and hospitalization for 1 day. Bloodwork and CT scan were done; the patient was observed overnight. The event was resolved on an unspecified date in Feb2021.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/06/2021,02/06/2021,0.0,UNK,ADVAIR; COMBIVENT; LOSARTAN; HYDROCHLOROTHIAZIDE; MELOXICAM; TAMOXIFEN; ASPIRIN [ACETYLSALICYLIC ACID]; CENTRUM SILVER [ASCORBIC ACID;BIOTIN;CALCIUM;CALCIUM PHOSPHATE DIBASIC;CHROMIC CHLORIDE;CUPRIC OXIDE; VITAMIN C [ASCORBIC ACID],,Medical History/Concurrent Conditions: Asthma; COPD; Ductal carcinoma in situ (prior DCIS); Marginal zone lymphoma (stable not treated at this time); Osteoarthritis; Sulfonamide allergy,,,"['Blood test', 'Computerised tomogram', 'Dysstasia', 'Gait inability']",1,PFIZER\BIONTECH, 1039933,FL,74.0,F,"Noticed light spotting; This is a spontaneous report from a contactable consumer reporting for herself. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number E19769 and expiry date unknown) on 06Feb2021 15:30 at single dose via an unspecified route of administration into her left arm for COVID-19 immunization. There were relevant medical history and no concomitant medications. The patient had not had COVID prior to the vaccination, COVID not tested post the vaccination. The patient was not pregnant. She noticed light spotting on 07Feb2021 at 21:45. No seriousness criterion provided. No treatment was received. The outcome of event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/06/2021,02/07/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Haemorrhage'],UNK,PFIZER\BIONTECH, 1039934,WI,54.0,F,"Big echo on right ear; Very tired; Discomfort on right arm injection site; This is a spontaneous report from a contactable nurse report for self. This 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, Expiry Date: Apr2021) Intramuscular injected in right deltoid on 24Jan2021 12:00 at single dose for COVID-19 immunization. Patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Diabetes surgically induced in 2013. None prior vaccinations within 4 weeks. She takes flu vaccine each year and never has any problems. None vaccines administered on the same date with BNT162B2. There were no concomitant medications. Patient got the first vaccine on 24Jan2021 and was fine. The next day on 25Jan2021 patient experienced discomfort on right arm injection site, and at 18:00, she was very tired, she wanted to just go to bed and not get up. On 26Jan2021 18:00, she started having a big echo in her right ear, the nurse considered ""Big echo on right ear"" was medically significant. She could hear herself talking to herself. Since then, she has a difference in her ears. She heard people from a distance if she closes right ear. Right now, it echo's so bad. She did not have a problem with her ear before the vaccine. The ear has improved but persisted. Some noises are intolerable and some are ok. She is going for second dose in 3 weeks. Workplace clinic visit on 28Jan2021. They looked at her ear and had no medical intervention. Events outcome was recovering. Relatedness of vaccine to all events reported ""related"".; Sender's Comments: By close temporal relationship and absence of factors which may provide an alternative cause the events reported as tinnitus, vaccination site discomfort and fatigue, may be attributed to suspect product BNT162b2; the event vaccination site discomfort is consistent with the known toxicity profile of the suspect product. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/25/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Chromosomal anomalies; Diabetes (Diabetes surgically induced in 2013.); Endocrine disorder; Immunocompromised; Obesity; Respiratory disorder,,,"['Fatigue', 'Tinnitus', 'Vaccination site discomfort']",1,PFIZER\BIONTECH,OT 1039935,TN,55.0,F,"anaphylactic reaction; Chest tightness; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261), via an unspecified route of administration on 30Jan2021 09:30 at single dose for covid-19 immunisation. Medical history included severe peanut allergy. Concomitant medication included diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), both for severe peanut allergy. She went to the Emergency Room after having an anaphylactic reaction on 31Jan2021. She was in the emergency room for four hours. She has taken Solu-Medrol and Benadryl. She has a severe peanut allergy that she had this medication for it. The anaphylactic reaction last for 24 hours. She also experienced chest tightness on 31Jan2021 that continued. She was given Epinephrine, Solu-Medrol and Benadryl in the ambulance. Therapeutic measures were taken as a result of anaphylactic reaction and chest tightness. The outcome of anaphylactic reaction was recovered on 31Jan2021, for chest tightness was not recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,OTH,BENADRYL; SOLU-MEDROL,,Medical History/Concurrent Conditions: Peanut allergy (severe peanut allergy),,,"['Anaphylactic reaction', 'Chest discomfort']",UNK,PFIZER\BIONTECH, 1039936,IL,,M,"The man walked approximately 30 feet and collapsed/fainted; Extremely diaphoretic; This is a spontaneous report from a non-contactable consumer (volunteer at a vaccination clinic) reporting for a patient. A male adult in his 30's received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date unknown) via an unspecified route of administration on 07Feb2021 around 15:00 at a single dose for COVID-19 immunization. No information about the patient's medical history and concomitant drugs was provided. After receiving the vaccine, the man walked approximately 30 feet and collapsed. The onsite supervisor from the institute indicated that he was extremely diaphoretic and had ""fainted"" before he could reach the post-vaccination observation area. EMS (Emergency Medical Services) was stationed onsite and assisted the man. The man was placed in a chair for approximately 15 minutes. An electrocardiogram (ECG) appeared to have been performed. The man was then transported to the hospital for further evaluation of concussion as it was believed that his head might have impacted a table and/or the floor when he collapsed. It was not specified if the patient was admitted to the hospital. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/07/2021,02/07/2021,0.0,UNK,,,,,,"['Electrocardiogram', 'Hyperhidrosis', 'Syncope']",1,PFIZER\BIONTECH, 1039939,CA,87.0,M,"fainted; nauseated; vomited 4 times; dizzy; bad headache; extremely tired; This is a spontaneous report from a contactable consumer. An 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Right arm (at age of 87-year-old) on 21Jan2021 at 12:00 PM as a single dose for COVID-19 immunisation, lot number: EL3247. Medical history was none. Patient had no allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included ibuprofen (ADVIL) and melatonin (minimal usage). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. It was reported that on 21Jan2021 at 02:45 PM (also reported as 2 1/2 hours after vaccine) patient became nauseated, he vomited four times, was dizzy, fainted, had bad headache and was extremely tired. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient was treated for the events with nausea medications and ibuprofen (ADVIL). Since the vaccination patient had not been tested for COVID-19. Patient recovered with lasting effects from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,PUB,ADVIL; MELATONIN,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Syncope', 'Vomiting']",1,PFIZER\BIONTECH, 1039940,CA,,F,"Blood clot in her leg; This is a spontaneous report from a non-contactable consumer (patient). This female patient of unspecified age (reported only as 72) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient believed she may have a blood clot in her leg since an unspecified date. She had the second vaccine dose scheduled on an unknown date. Event outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Thrombosis'],1,PFIZER\BIONTECH, 1039941,,66.0,M,"hospitalized with viral meningitis; Headaches; fever; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 24Jan2021 at 12:15 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient experienced headaches and fever on 26Jan2021. The patient experienced viral meningitis on 01Feb2021 and was hospitalized with viral meningitis. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment was received for the adverse events. The no days of hospitalization was 8. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,8.0,Not Reported,N,01/24/2021,01/26/2021,2.0,UNK,,,,,,"['Headache', 'Meningitis viral', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1039942,VA,36.0,F,"Fainting like episodes; Blurred vision; Severe vertigo; Chest pain; Fatigue; This is a spontaneous report from a contactable other health professional reported for herself. A 36-year-old female patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EL8982, via an unspecified route of administration in right arm on 15Jan2021 12:00 at single dose for covid-19 immunisation. There were no relevant medical history or concomitant medications. The patient was not pregnant at the time of vaccination.The patient had no allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.On 21Jan2021, exactly ""4 1/2 days"" after vaccine the patient experienced fainting like episodes, blurred vision, severe vertigo, chest pain, fatigue. The patient has been out of work since the 20th and she still had blurred vision. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was received. The patient was not recovered from the events. She has been to the ER, cardiologist for an echography, ultrasonography of thyroids, Magnetic resonance imaging (MRI) of her head, went to ENT dr and neurologist in 2021. All blood work in 2021 came back normal as well. The reporter considered the event as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. She had negative Nasal Swab Covid test post vaccination on 22Jan2021.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of fainting like episodes cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/21/2021,6.0,SCH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Blood test', 'COVID-19', 'Chest pain', 'Fatigue', 'Magnetic resonance imaging', 'Syncope', 'Ultrasound scan', 'Ultrasound thyroid', 'Vertigo', 'Vision blurred']",1,PFIZER\BIONTECH, 1039943,MI,,M,"Unresponsive to stimuli; Loss of consciousness; Irregular breathing; Nausea; Snoring; Staring; This is a spontaneous report from a non contactable consumer. A 46-years-old male patient received the first dose of bnt162b2 (BNT162B2; Lot # EK9231) vaccine , intramuscular in the left arm on 28Dec2020 at single dose for Covid-19 immunisation. Medical history included exercise induced asthma, penicillin hypersensitivity. Previously the patient received flu vaccine and TDAP vaccine and experienced nausea and body aches about 2010. The patient's concomitant medications were not reported. The patient was unresponsive to stimuli on 29Dec2020 with outcome of recovered , experienced loss of consciousness on 29Dec2020 with outcome of recovered , had irregular breathing on 29Dec2020 with outcome of recovered , nausea on 29Dec2020 with outcome of recovered , snoring on 29Dec2020 with outcome of recovered , staring on 29Dec2020 with outcome of recovered. The events loss of consciousness and unresponsive to stimuli were considered Important Medical Events. It was reported that the patient woke up in the night, walked downstairs to get water, walked back upstairs and became nauseous, laid down and became unresponsive. Eyes were open but not focused, breathing was irregular and snoring-like. This lasted less than a minute and he regained consciousness. No follow up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,WRK,,,Medical History/Concurrent Conditions: Exercise induced asthma; Penicillin allergy,,,"['Irregular breathing', 'Loss of consciousness', 'Nausea', 'Snoring', 'Staring', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,OT 1039944,KS,88.0,F,"Drop in hemoglobin level; Idiopathic thrombocytopenic purpura; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 04Feb2021, at single dose, for COVID-19 immunisation. Medical history included diabetes mellitus, hypertension and other unspecified conditions. Patient did not have known allergies and did not have COVID-19 prior to vaccination. Concomitant included unspecified multiple medications. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. The patient experienced drop in hemoglobin level resulting in idiopathic thrombocytopenic purpura (ITP) on 04Feb2021 with outcome of not recovered. The event resulted in physician office visit and emergency room visit. Patient had no history of ITP prior to vaccination. The event was considered serious as caused patient's hospitalization and as life threatening. The patient underwent lab tests and procedures which included hemoglobin: drop on 04Feb2021. Therapeutic measures were taken as a result of the event and included treatment with multiple unspecified drugs. It was unknown if she was tested for COVID-19 after vaccination. The information on the lot/batch number has been requested.",Not Reported,,Yes,Yes,,Not Reported,N,02/04/2021,02/04/2021,0.0,SEN,,,Medical History/Concurrent Conditions: Blood pressure high; Diabetes,,,"['Haemoglobin', 'Haemoglobin decreased', 'Immune thrombocytopenia']",2,PFIZER\BIONTECH, 1039945,SC,78.0,M,"He was bleeding, it came out from his rectum through feces; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunization. The relevant medical history included gout. Concomitant medications included colchicine for gout and a lot of unspecified medications. The patient took a COVID vaccine yesterday and this morning he was bleeding through the 'raw', it came out from his rectum through feces on 07Feb2021. He stated that the next shot was between 27Feb and 19Mar (Clarification unknown). So it was one day between those two days. He said he still was just a little bit, not like he was. No treatment was received for the event. The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/07/2021,1.0,UNK,COLCHICINE,,Medical History/Concurrent Conditions: Gout (Patient Medical comments: Verbatim: Gout),,,['Haematochezia'],UNK,PFIZER\BIONTECH, 1039948,,,M,"diagnosed with cellulitis; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (wife) reported for husband that a male patient of an unspecified age received bnt162b2, via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced diagnosed with cellulitis and in hospitalization on an unspecified date with outcome of unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,['Cellulitis'],1,PFIZER\BIONTECH, 1039949,MO,,M,"He did have a slight A fib condition; his blood pressure went 189; his temperature was 103; He was really sick; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer who reported for her brother. A male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at single dose on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The day after his vaccine, his blood pressure went 189/ over something, and his temperature was 103. He was really sick. He did have a slight A fib condition. Outcome of the events was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093425 Same reporter/ vaccine, different patient and events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Atrial fibrillation', 'Blood pressure increased', 'Blood pressure measurement', 'Body temperature', 'Body temperature increased', 'Illness']",UNK,PFIZER\BIONTECH, 1039950,MI,59.0,F,"Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blurred vision; dizziness; neuropathic pain; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER9831, Intramuscular in left arm on 11Jan2021 08:20 at single dose for COVID prevention. Medical history included Asthma Moderate persistent on 20Jun2020. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 on 23Dec2020 and experienced Aches, Fever 102 degree, myalgia, and headache. The patient experienced 101 degree, myalgia, Headache after the second dose of BNT162B2. The patient experienced Bell's palsy and occipital neuralgia on 28Jan2021 10:00 which resulted in stroke woke up and will lead to time off work and further imaging of cervical spine and possible nerve blocks. She had blurred vision and dizziness in addition to severe cephalgia and neuropathic pain. Treated with Aleve, steroids, Acyclovir + neurontin. Duration unknown as still with symptoms. The events Bell's palsy and occipital neuralgia resulted in Emergency room visit. Lab data included CT head with illegible Head Contrast, CT Angiogram head and MRI Head on 27Jan2021 with Result: NI. The outcome of Bell's palsy was Resolved with Sequel. The outcome of the event Stroke was unknown. The outcome of Fever 101 degree, Myalgia was resolved. The outcome of other events was not resolved.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be completely excluded based on temporal association. The information currently available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020512578 Same patient/reporter,drug, different dose",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/28/2021,17.0,PVT,,,Medical History/Concurrent Conditions: Asthma (Moderate persistent),,,"['Angiogram', 'Body temperature', 'Cerebrovascular accident', 'Computerised tomogram head', 'Dizziness', 'Facial paralysis', 'Headache', 'Magnetic resonance imaging', 'Myalgia', 'Neuralgia', 'Occipital neuralgia', 'Pyrexia', 'Vision blurred']",2,PFIZER\BIONTECH,OT 1039951,NJ,66.0,F,"Severe Headache; eye pain; earache on side of shot; itching both arms; severe jaw pain; severe chest pain; body ache; high fever; fatigue; profuse sweating; belabored breathing; hot; butterfly rash of face; This is a spontaneous report from a contactable physician (patient). A 66-year-old female (Not pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at right arm on 11Feb2021 14:30 at single dose for covid-19 immunization. Medical history included hypothyroidism, hypertension, hypercholesterolemia, breast cancer, osteoporosis, ligamentous RA, degenerative joint disease (DJD). The patient had known allergies to cilantro, cephalosporins, all morphine and morphine derivatives, Herceptin, astralogous mushrooms, gadolinium dye, fentanyl. The patient's concomitant medications reported as other medications in two weeks was yes.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, eye pain, earache on side of shot, itching both arms, severe jaw pain, severe chest pain, body ache and high fever &fatigue - profuse sweating, belabored breathing hot butterfly rash of face on 12Feb2021 at time of 06:00 AM. AEs resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient received Prednisone 80 mg and Benadryl 50 mg as treatment. Prior to vaccination, the patient was diagnosed with COVID-19. Covid was tested post vaccination. The patient underwent lab tests and procedures which included Nasal Swab and PCR test: negative on 09Feb2021. The outcome of events was recovering. Information on Lot/Batch has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/11/2021,02/12/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Breast cancer; Contrast media allergy; COVID-19 (Prior to vaccination); Degenerative joint disease; Food allergy; Hypercholesterolemia; Hypertension; Hypothyroidism; Osteoporosis; Rheumatoid arthritis,,,"['Body temperature', 'Butterfly rash', 'Chest pain', 'Ear pain', 'Eye pain', 'Fatigue', 'Feeling hot', 'Headache', 'Hyperhidrosis', 'Pain', 'Pain in jaw', 'Pruritus', 'Pyrexia', 'Respiratory disorder', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1039952,,,U,"Two report of death related to the vaccine were reported in a young premature baby and 25-year-old young person who dies 15 minutes after receiving the vaccine.; a young premature baby received BNT162B2; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar event for 2 patients. This is 1st of 2 reports. A patient of unspecified age and gender (reported as a young premature baby) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The consumer stated his main concern was even though the vaccine had been authorized. The vaccine was only given vaccine on the side of the road. People were dying from the vaccine more than from the virus. He gave out some percentage of people that could die from the virus vs from the vaccine. The percentage of death rate was 0.00045% from the virus. The percentage of death from the vaccine was 6.6%. There were many people reporting side effects such as bell's palsy, whole body convulsion. Two report of death related to the vaccine were reported in a young premature baby and 25-year-old young person who died 15 minutes after receiving the vaccine. He said it's sad these were front line worker who were facing all these side effects. The outcome of the event was fatal. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021157531 same reporter, drug, event, different patient; Reported Cause(s) of Death: Two report of death related to the vaccine were reported in a young premature baby and 25-year-old young person who dies 15 minutes after receiving the vaccine.",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Death', 'Off label use']",UNK,PFIZER\BIONTECH, 1039954,,,U,"Two report of death related to the vaccine were reported in a young premature baby and 25-year-old young person who dies 15 minutes after receiving the vaccine.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar event for 2 patients. This is 2nd of 2 reports. A 25-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The consumer stated his main concern was even though the vaccine had been authorized. The vaccine was only given vaccine on the side of the road. People were dying from the vaccine more than from the virus. He gave out some percentage of people that could die from the virus vs from the vaccine. The percentage of death rate was 0.00045% from the virus. The percentage of death from the vaccine was 6.6%. There were many people reporting side effects such as bell's palsy, whole body convulsion. Two report of death related to the vaccine were reported in a young premature baby and 25-year-old young person who died 15 minutes after receiving the vaccine. He said it's sad these were front line worker who were facing all these side effects. The outcome of the event was fatal. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021155151 same reporter, drug, event, different patient; Reported Cause(s) of Death: Two report of death related to the vaccine were reported in a young premature baby and 25-year-old young person who dies 15 minutes after receiving the vaccine.",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],UNK,PFIZER\BIONTECH, 1039955,OH,73.0,F,"almost comatose/couldn't get a response; really really hot/took her temperature it was 101.8/fever; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported for two patients. This is the first of two reports. A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318 and expiration date 31May2021), via an unspecified route of administration in the right arm on 02Feb2021 at a single dose for COVID-19 immunization. Medical history included ongoing Type 1 diabetic; Alzheimers from 2014 and ongoing, about 7 years ago; and covid-19 from Dec2020 to Dec2020. There were no concomitant medications. At 4 am yesterday morning (03Feb2021), she developed side effects. The patient's husband woke up at 4 am and touched the patient to make sure she was okay like he does every night. When he did, patient was really really hot. He took her temperature it was 101.8. She was almost comatose, and he couldn't get a response from her. He gave her fluid with a straw on her lips. At 7:30 am, 3.5 hours later, she was still hot. He was putting cold compresses on her. He called the hospice nurse, and she came and checked her vitals. She had a fever of 101.5 that time. He continued cold compresses. Her vitals were stable. Then about afternoon, her fever broke, and she became coherent. The rest of yesterday, and today she seems to be fine. She had a side effect that caused her to have a fever and be out of it. He couldn't get a response from her until noon yesterday. When the fever broke around noon, that is when she became more responsive and back to normal. Outcome of the events was recovered on 03Feb2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021156644 same reporter/drug, different patient/event",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/03/2021,1.0,UNK,,Alzheimer's disease (about 7 years ago); Type I diabetes mellitus (Verbatim: Type 1 diabetic),Medical History/Concurrent Conditions: COVID-19,,,"['Body temperature', 'Depressed level of consciousness', 'Investigation', 'Pyrexia']",1,PFIZER\BIONTECH, 1039956,,,U,"got diagnosed with Covid19 afterwards; got diagnosed with Covid19 afterwards; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient and had the first shot (unclear if Pfizer or Moderna) and got diagnosed with Covid-19 afterwards (dates unspecified). The outcome of the event diagnosed with Covid-19 was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1039989,AL,76.0,M,Patient had an NSTEMI wihtin 3 days of receiving the vaccine.,Not Reported,,Not Reported,Yes,4.0,Not Reported,U,01/28/2021,02/01/2021,4.0,PVT,Unknown,Unknown,Unknown,,Unknonw,['Acute myocardial infarction'],1,MODERNA,IM 1040005,NY,72.0,F,Patient was found unresponsive and had passed away.,Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,PHM,Unknown,Unknown,Unknown,,No known allergies,"['Death', 'Unresponsive to stimuli']",2,MODERNA,IM 1040020,AZ,88.0,M,Shortness of breath beginning 4 days after vaccination. Pacemaker was checked per wife and it was fine.,Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/13/2021,02/17/2021,4.0,PHM,,,pacemaker,,,['Dyspnoea'],2,MODERNA, 1040074,TX,39.0,F,"Throat tight, hard to swallow, extreme dry mouth, chills, shaking, anxiety",Not Reported,,Yes,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,PVT,Hydrocodone 5-325 Daily vitamins 1000 vitamin d 1000 vitamin b12 Folivan,Rhumetoid arthritis Migraines Low iron Anxiety,Rhumetoid arthritis Migraines Low iron Anxiety,,Latex Amoxicillan Augmentin Ativan Methotrexate,"['Anxiety', 'Chills', 'Dry mouth', 'Dysphagia', 'Throat tightness', 'Tremor']",1,PFIZER\BIONTECH,SYR 1040139,OH,89.0,M,The patient is positive for COVID-19 requiring hospital admission with supplementary oxygen and administration of dexamethasone. Symptoms of COVID-19 began on 2/15/21 and hospital presentation occurred on 2/18/21.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/12/2021,02/15/2021,3.0,UNK,"acetaminophen, albuterol, Eliquis, vitamin C, aspirin, atorvastatin, Coenzyme Q10, digoxin, ezetimibe, fenofibrate, finasteride, furosemide, nitroglycerin, sotalol, tamsulosin, vitamin D, zinc gluconate",,"CAD, hypertension, BPH, osteoarthritis, CKD stage 3, hypercholesterolemia, CHF (systolic), Atrial Fibrillation, asthma, degenerative disk disease, implanted ICD",,"Cat hair, dust mites, grass seed, penicillin","['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 1040170,OR,37.0,F,"Received vaccine on 2/6/2021. was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up, had shower. caregivers noted her extremities were cool and face was red. temp was 97.4. She was placed in wheelchair with book in the living room. caregivers noted she was not turning pages of the book as she usually would. She was tracking, so they don't think she had a seizure. Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911. She was found with agonal breathing, CPR started, intubated by EMS, taken to the ER and diagnosed with cardiac arrest upon arrival. CPR was continued until family could be reached and decision was made to stop resuscitation.",Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/13/2021,7.0,OTH,"Tylenol, calcium citrate, antifungal cream to stoma, Bisacodyl suppository as needed, calcium citrate, tube feeds, lansoprazole, reglan, centrum multivitamin, polyethylene glycol every other day, norgestimate-estradiol daily, trazodone, tiz",none. she had been very stable on her medication regimen and in her living arrangement for years. No issues whatsoever. Caregivers had been caring for her for as long as 19 years.,"cerebral palsy, spastic quadriplegia, dysphagia with g-tube in place, developmental delay - minimally verbal, tube feed dependency, intrathecal baclofen pump, osteoporosis, white coat hypertension, candidiasis of skin..",,"reclast - caused fever in 2014, leading to hospitalization, seizure from the fever.. tegretol (no reaction noted)","['Abnormal behaviour', 'Agonal rhythm', 'Alanine aminotransferase increased', 'Analgesic drug level therapeutic', 'Aspartate aminotransferase increased', 'Blood creatinine increased', 'Blood glucose decreased', 'Blood lactic acid increased', 'Blood magnesium increased', 'Blood potassium increased', 'Cardiac arrest', 'Cyanosis', 'Endotracheal intubation', 'Erythema', 'Pain', 'Peripheral coldness', 'Pyrexia', 'Respiration abnormal', 'Resuscitation', 'Troponin increased', 'White blood cell count increased']",1,MODERNA,IM 1040177,TN,87.0,F,PATIENT STATED SHE FELT LIGHT HEADED A FEW MINUTES AFTER INJECTION. SHE THOUGHT IT WAS HER DIABETES AND SON BROUGHT HER ORANGE JUICE. SHE VOMITED SHORTLY AFTER THAT. SHE CONTINUED TO FEEL LIKE SHE MIGHT FAINT. EMT'S CAME AND TRANSPORTED TO HOSPITAL. WE TELEPHONED SON LATER AND HE STATED MI WAS RULED OUT AND THEY THOUGHT IT MIGHT BE AN ISSUE WITH BLOOD PRESSURE AND HEART RATE.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/18/2021,02/18/2021,0.0,PHM,none listed on Vaccine Administration Record and Informed Consent Form,None Listed on Vaccine Administration Record and Informed Consent Form,"None Listed on Vaccine Administration Record and Informed Consent Form - however after she started feeling bad, she said she thought it was just her diabetes",,None listed on Vaccine Administration Record and Informed Consent Form,"['Dizziness', 'Vomiting']",1,MODERNA,IM 1040183,OH,94.0,F,"Patient had swelling around her jaw after her second shot of the covid , Pfizer vaccine ( .5 ml IM) on the Friday morning, January 29th, I took her to a follow up appointment with the cardiologist at 3:00 pm, as a follow up to a small heart attack event with hospitalization two weeks previously, at the cardiologist she was given the ok/all is well. That next morning early, she had a 911 event at her assisted living apartment and was sent back to the hospital, having had another heart attack. Patient died on the following Thursday, February 4, 2021. I do not know if the vaccination had any cause for my mothers death; but I feel it is necessary to report this series of heart attacks after she received the pfizer vaccine. Her Certificate of Death records the cause of death as ""Coronary Artery Disease"".",Yes,02/04/2021,Not Reported,Yes,6.0,Not Reported,N,01/29/2021,01/29/2021,0.0,UNK,,CHF,"CHF, Diabetes",,,"['Coronary artery disease', 'Death', 'Myocardial infarction', 'Swelling face']",2,PFIZER\BIONTECH, 1040240,NY,36.0,M,"severe intestinal pain. diagnosed with appendicitis, appendectomy removed",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/07/2021,02/15/2021,8.0,MIL,None,None,None,,None,"['Appendicectomy', 'Appendicitis', 'Blood test', 'Computerised tomogram', 'Gastrointestinal pain', 'X-ray']",1,PFIZER\BIONTECH, 1040290,MA,80.0,M,"Severe thrombocytopenia with platelet count of 1,000.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/08/2021,02/15/2021,7.0,PVT,"Tramadol, diazepam, finasteride, pancrelipase, allopurinol, hydrochlorothiazide, ezetimibe, Lupron, rivaroxaban, insulin","Prostate cancer, urethral polyp biopsy on 2/4/21.","Prostate cancer (localized) HTN Diabetes DVT and prothrombin gene mutation, but last clot in 2013 CAD",,Pravastatin,"['Haemoglobin normal', 'Platelet count increased', 'Thrombocytopenia', 'White blood cell count normal']",UNK,PFIZER\BIONTECH, 1040300,CT,41.0,M,"Patient�is a 41 y.o.�male�on no AC/AP with no pmhx reported presents 1/31 PM initially to Hospital for acute onset 10/10 headache refractory to 800mg motrin which started in occipital region then spread to whole head and neck, nausea and vomiting x 3. Symptoms started around 5pm when he was on a conference call and reports he got bad news so was stressed out. Denies any recent trauma. � Pt received toradol 30mg, dexamethasone 10mg, benadryl 25mg and reglan 10mg at hospital prior to transfer. CT showed diffuse SAH and CTA showed no signs of obvious aneurysms. He then received 1g IV keppra and was started on Cardene for BP goal <140. He was transferred to NICU for further monitoring. � While in the NICU, his exam and imaging remained stable. He underwent CTA which was unrevealing, and DSA which showed evidence of vasculopathy. BPs came down to <160 and he came off of cardene, did not require additional meds. He was transferred to the floor. Upon transfer, he had another thunderclap HA, accompanied by HTN to the 200s systolic, tachycardia to the 120s, diaphoresis, and blotchy macular rash over the anterior shoulders. Imaging was negative for vasospasm or recurrent bleed, and it was felt that patient's presentation was most c/w RCVS. Trigger felt either 2/2 caffeine intake (patient reported drinking 60 oz coffee daily) vs. Sympathetic discharge syndrome such as pheochromocytoma or carcinoid syndrome. LP was performed, which revealed no nucleated cells and protein elevated in proportion to blood, which confirmed the diagnosis of RCVS. Studies were sent off to diagnose carcinoid syndrome and pheo. Patient was started on nimodipine/gabapentin with standing tylenol and PRN oxycodone for breakthrough pain. Within days, the HAs had markedly decreased in intensity. He was taken off of keppra after 1 week with stable exam and no e/o seizures. He was briefly switched from nimodipine to verapamil but switched back prior to discharge. He was discharged with outpatient followup.",Not Reported,,Yes,Yes,10.0,Not Reported,Y,01/26/2021,01/31/2021,5.0,PUB,none,none,none,,none known,"['Angiogram', 'Angiogram abnormal', 'Blood pressure decreased', 'Blood test normal', 'Breakthrough pain', 'Caffeine consumption', 'Carcinoid syndrome', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram abnormal', 'Computerised tomogram head abnormal', 'Headache', 'Hyperhidrosis', 'Hypertension', 'Intensive care', 'Magnetic resonance imaging abdominal abnormal', 'Nausea', 'Neck pain', 'Normetanephrine urine increased', 'Paroxysmal sympathetic hyperactivity', 'Phaeochromocytoma', 'Protein total', 'Rash', 'Rash macular', 'Renal cyst haemorrhage', 'Renal mass', 'Reversible cerebral vasoconstriction syndrome', 'Stress', 'Subarachnoid haemorrhage', 'Tachycardia', 'Thunderclap headache', 'Ultrasound Doppler normal', 'Vasculitis', 'Vomiting']",1,MODERNA,IM 1040308,,83.0,M,"Pfizer-BioNTech COVID-19 Vaccine EUA Patient presented to the ER on 2/14/21 after experiencing night sweats, fevers, urinary incontinence, flank pain, and generalized fatigue for 5 days. Admitted and treated empirically for sepsis. No source of infection found, fevers continued on IV antibiotics.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/09/2021,02/09/2021,0.0,PUB,"Metformin, cyclobenzaprine, ciprofloxacin, acyclovir, acetaminophen, larotrectinib, senna, pantoprazole, finasteride, lorazepam, ondansetron","Sepsis, Generalized muscle weakness, hematuria, Acute respiratory failure, hypoxia, cough, congestion, night sweats, flank discomfort, urinary incontinence","BPH, GERD, Type 2 diabetes, AML, paroxysmal atrial fibrillation, prolonged INR, coagulopathy, anemia, dyslipidemia, peripheral neuropathy, constipation",,none,"['Fatigue', 'Flank pain', 'Night sweats', 'Pyrexia', 'Respiratory viral panel', 'SARS-CoV-2 test negative', 'Sepsis', 'Urinary incontinence', 'Viral test negative']",1,PFIZER\BIONTECH,IM 1040312,CA,44.0,M,expressive aphasia. Improved without directed therapy,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/10/2021,02/13/2021,3.0,PVT,,,,,,"['Aphasia', 'CSF glucose normal', 'CSF lymphocyte count increased', 'CSF protein increased', 'CSF white blood cell count negative', 'Electroencephalogram abnormal']",UNK,PFIZER\BIONTECH, 1040340,PA,66.0,F,"Enlarged or inflamed heart, lungs full of fluid, myocarditis, vomiting, dehydration",Not Reported,,Yes,Yes,5.0,Not Reported,U,02/11/2021,02/11/2021,0.0,PVT,Bi-polar medications,None,Obesity,,unknown,"['Bacterial test', 'Blood test', 'Cardiomegaly', 'Dehydration', 'Echocardiogram', 'Myocarditis', 'Pulmonary oedema', 'Viral test', 'Vomiting']",1,PFIZER\BIONTECH,IM 1040343,NY,70.0,F,"2/9: Received vaccine 2/12: Brain fog - actions disassociated from thoughts 2/14: Altered mental status - in a ""fog""; transported to ER via ambulance; neuro exam , diagnostics (CT with & w/o contrast, CTA, CT perfusion, MRI, EEG), COVID -19 PCR, blood work/urine - all negative for intracranial bleed/stroke/tumor, ischemic changes, perfusion issues, seizures, COVID, etc. Diagnosis: Transient Global Amnesia (TGA). Admitted overnight. Amnesia event lasted 7hrs from onset and mental status returned to baseline with no residual effects. The 7hr amnesia period is unable to be recalled.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/09/2021,02/12/2021,3.0,PHM,"Ramipril, Coreg, Levothyroxine, Fosamax, Minocycline, Flonase, Vit D3, Probiotics, Vitamin C, Calcium/Mag/Zinc",2/1/2021: Sinus headache w/nausea & vomiting,"Hypertension, Hypercholesterolemia, Rheumatoid Arthritis, Osteopenia",,"Codeine, Benadryl","['Amnesia', 'Angiogram', 'Angiogram normal', 'Blood gases normal', 'Blood test normal', 'Computerised tomogram normal', 'Electrocardiogram', 'Electroencephalogram normal', 'Feeling abnormal', 'Magnetic resonance imaging normal', 'Mental status changes', 'Neurological examination normal', 'Perfusion brain scan', 'SARS-CoV-2 test negative', 'Scan with contrast', 'Transient global amnesia', 'Urine analysis normal']",1,MODERNA,IM 1040411,CA,39.0,F,"01/09/21, 25 minutes after I got my 2nd dose, I felt heart palpitation. I my heart rate was 109 at sitting. I feel my heart beats stronger than normal. my heart palpitation didn't improve overnight. 01/10/21 I feel shortness of breath with talking and walking. My chest hurts. My head hurst. I call my hospital and talked to an RN urgent line. She suggested me to go to Urgent Care or ER. I went to Urgent Care at 1500 that day. At check in my blood pressure was 160/110 (my normal BP is around 120/90 or less) heart rate was 112. EKG was done, result no concern. Urgent Care Doctor sent me home with no medication. He said what I experienced is the reaction of my body with the Covid vaccine. He told me to go to ER if my symptoms get worse. I went and see my primary doctor ( bloods tests was done ) and Cardiologist after with EKG and ECHO done. I was off from work during that time. I feel back to normal after 10 days.",Not Reported,,Not Reported,Not Reported,,Yes,Y,01/09/2021,01/09/2021,0.0,PVT,NEOCELL SUPER COLLAGEN + C AND BIOTIN 3 tabs daily,NONE,NONE,,NONE,"['Chest pain', 'Dyspnoea', 'Echocardiogram normal', 'Electrocardiogram normal', 'Full blood count normal', 'Headache', 'Palpitations', 'SARS-CoV-2 test negative', 'Thyroid function test normal']",2,PFIZER\BIONTECH,IM 1040422,NC,96.0,F,"Morning following 2nd vaccination patient was confused and not able to keep herself upright in a char, stand or feed herself . All of which she could do the day before. She was sent to medical center for MRI and they found no evidence of stroke and sent her back. She was then sent to rehab where she continued to weaken and not be able to eat or drink . A week later she is now under Hospice care.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/18/2021,02/19/2021,1.0,SEN,,none,none,,,"['Asthenia', 'Confusional state', 'Dysstasia', 'Feeding disorder', 'Fluid intake reduced', 'Magnetic resonance imaging normal']",2,PFIZER\BIONTECH,IM 1040574,GA,66.0,F,Patient collapsed and could not be revived. There was no prior warning. She was otherwise in good condition for her age. The death was listed as probable cardiac arrest but no autopsy was performed. Since it occurred so close to the vaccine shot I thought someone may want to know.,Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/16/2021,8.0,UNK,,,,,,"['Cardiac arrest', 'Death', 'Syncope', 'Unresponsive to stimuli']",1,MODERNA,SYR 1040528,,,F,"Adverse reaction; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed an adverse reaction. The patient's medical history was not provided. Concomitant product use was not provided. On 13 Jan 2021 prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly for prophylaxis of COVID-19 infection. After receiving the vaccine, the patient stated she experienced an adverse reaction. Treatment for the event included hospitalization. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, adverse reaction, was considered unknown.; Reporter's Comments: This case concerns a female patient of unknow age patient received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly for prophylaxis of COVID-19 infection and developed a serious medically significant unlisted event of adverse reaction. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/13/2021,01/13/2021,0.0,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No adverse event, Continue: [UNK], Comment: No reported medical history.",,,['Vaccination complication'],1,MODERNA,OT 1040529,NY,58.0,M,"Abscess and tissue necrosis at the injection site; Abscess and tissue necrosis at the injection site; Scarred; A spontaneous report was received from a nurse who is a 58-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed an abscess and tissue necrosis at the injection site and scarred. The patient's medical history was not provided. No concomitant product use was reported. On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Approximately 6 to 7 days after the patient received the Moderna COVID-19 vaccine, the patient had an abscess and tissue necrosis at the injection site. The patient did not require hospitalization and self-treated it with polysporin. On 20 Dec 2020, the patient reported the reaction had not resolved and was now scarred. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, abscess and tissue necrosis at the injection site and scarred, were considered not resolved.; Reporter's Comments: This case concerns a 58 year-old, male patient, who experienced events of an abscess and tissue necrosis at the injection site and scarred. The events occurred 6 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Injection site abscess', 'Vaccination site necrosis', 'Vaccination site scar']",1,MODERNA,OT 1040530,CA,28.0,F,"Facial edema, oropharyngeal edema; Lip swelling; Throat itching; Tachycardia; A spontaneous report was received from a healthcare professional concerning a 28-year-old female, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed lips swelling, throat itching, facial edema, and oropharyngeal edema. The patient's medical history was not provided. Concomitant product use was not reported. On 15 Jan 2021, approximately five minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection. On 15 Jan 2021, five minutes after the vaccine was administered, at 11:15am, the patient complained of lip swelling and throat itching. A healthcare provider assessed the patient and vital signs included, pressure 132/103 mmHg, heart rate 95 beats per minute, and 100 percent oxygen saturation. At 11:22am, the patient had facial edema, oropharyngeal edema and attempted to clear her throat. Vital signs reported at that time included, blood pressure 143/106 mmHg, heart rate 121 beats per minute, and oxygen saturation 99 percent. Treatment for the event included diphenhydramine 50mg and epinephrine by injection twice. Emergency services were called to transport the patient, however, the patient declined transport. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, lip swelling, throat itching, facial edema, and oropharyngeal edema, was unknown.; Reporter's Comments: This case concerns a 28 year-old, female patient, who experienced events of lips swelling, throat itching, facial edema, and oropharyngeal edema. The events occurred within minutes after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/15/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Angioedema', 'Blood pressure measurement', 'Heart rate', 'Lip swelling', 'Oxygen saturation', 'Tachycardia', 'Throat irritation']",1,MODERNA,OT 1040531,,,U,"Blacked out; Anaphylactic reaction; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction and blacked out. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On unknown date, after receiving the vaccine, the patient experienced an anaphylactic reaction and blacked out. The patient was placed on a ventilator for the events. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the event, anaphylactic reaction and blacked out, was unknown.; Reporter's Comments: This case concerns a patient of unknown of age and gender. The medical history is not provided. On unknown date after receiving their first of two planned doses of mRNA-1273 (Lot unknown), the patient experienced medically significant events of Anaphylactic reaction and Loss of consciousness. Treatment included placed on a ventilator for the events. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Anaphylactic reaction', 'Loss of consciousness']",1,MODERNA,OT 1040532,,,U,"Passed out and was unconscious for approximately 5 minutes; Nausea; Tightening or squeezing sensation of my chest; Tired; Vasovagal event; A spontaneous report was received from a healthcare professional who is the patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tightening or squeezing sensation in my chest, passed out, unconscious for approximately 5 minutes, nausea, vasovagal event and tired. The patient's medical history was not provided. No concomitant product use was reported. On 28 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection. On 29 Jan 2021, at 01:30, the patient reported they started to feel a tightening or squeezing sensation in their chest. On 29 Jan 2021 at 02:30, the patient's symptoms worsened, they reported increased chest tightening and were nauseated. The patient went into their bathroom and ""I passed out and ended up on the floor"". The patient reported they were unconscious for approximately 5 minutes. The patient's wife called 911 due to chest pains and to rule out a mild heart attack. The patient stated, ""all tests came back negative"". The patient stated they had a vasovagal event while in the hospital with a blood pressure reading of 77/40. Patient feeling better now, but still tired"". Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, tightening or squeezing sensation in my chest, passed out, unconscious for approximately 5 minutes, nausea, vasovagal event and tired, were considered unknown.; Reporter's Comments: This spontaneous report from a healthcare professional of unknown gender who experienced the serious events of unconscious, passed out and tightening or squeezing sensation in my chest and non-serious events of nausea, vasovagal event and tired. The events occurred 1 day after the administration of mRNA-1273 vaccine (Lot number: unknown, expiration date: unknown). Treatment given was not provided and outcome is resolved. Based on the information provided which shows a temporal association a causal association, between the reported events and the administration of mRNA-1273 vaccine cannot be excluded. The events of nausea and fatigue are consistent with the known safety profile of mRNA -1273 vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/29/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Blood pressure measurement', 'Chest discomfort', 'Fatigue', 'Loss of consciousness', 'Nausea', 'Presyncope']",2,MODERNA,OT 1040533,CA,72.0,M,"Syncope; Diarrhea; Low pressure; Flu-like symptoms; A regulatory report was received from a consumer concerning a 72-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced flu-like symptoms, head went back, eyes went white, jaw move left to right, made a last breath, thought he died, diarrhea and low pressure. The patient's medical history included high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included Metoprolol succinate. On 24 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (042L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 25 Jan 2021, the patient reported flu-like symptoms. Treatment information was not provided. On 26 Jan 2021, the patient reported head went back, eyes went white, jaw move left to right, made a last breath, thought he died, diarrhea and low pressure. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The event, flu-like symptoms was considered recovered/resolved on 25 Jan 2021. The events, head went back, eyes went white, jaw move left to right, made a last breath, thought he died, and diarrhea was considered recovered/resolved on 26 Jan 2021. The outcome of the event low pressure was unknown.; Reporter's Comments: This case concerns a 72 year old male with medical history of hypertension on metoprolol, who experienced a serious unexpected event of syncope and non-serious unexpected events of flu-like symptoms, diarrhea, and low blood pressure. Event onset was 1 day after first dose of mRNA-1273. Flu-like symptoms resolved. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/25/2021,1.0,UNK,SELOKEN ZOK,Blood pressure high,,,,"['Diarrhoea', 'Hypotension', 'Influenza like illness', 'Syncope']",1,MODERNA,OT 1040534,IN,,M,"Mastocytosis symptoms; flare up of Mastocytosis; A spontaneous report was received from a nurse who was also a 90 years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced a flare up of mastocytosis symptoms (mastocytosis and condition aggravated). The patient's medical history included mastocytosis. Products known to have been used by the patient, within two weeks prior to the event, included cimetidine and diphenhydramine hydrochloride. The patient received their first of two planned doses of mRNA-1273 (Lot number 039K20A), intramuscularly, in the left arm on 30 Dec 2020 for prophylaxis of COVID-19 infection. On 02 Jan 2021, 48 hours after vaccination, the patient went to the emergency room (ER) with mastocytosis symptoms including low grade hives, increased heart rate, burning sensation and heat on the skin. The patient had a long history of mastocytosis and carried an ephedrine and diphenhydramine hydrochloride. The ER physician thought the vaccine caused flare up of mastocytosis. The patient was given diphenhydramine hydrochloride and methylprednisolone and sent home. A few days later, the patient had another episode of the same symptoms and went to the ER again on 15 Jan 2021. The physician recommended the patient wait and not get the second shot which was due on 28 Jan 2021. Treatment for the event included diphenhydramine hydrochloride and methylprednisolone. The second dose of mRNA-1273 was temporarily withheld in response to the event. The outcome of the event, flare up of mastocytosis symptoms, was not reported.; Reporter's Comments: This is a 90 year male patient with relevant medical history of mastocytosis which is a confounding factor that may a play contributory role providing an alternative explanation. Further information is requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/02/2021,3.0,UNK,CIMETIDINE; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE],Mastocytosis,,,,"['Condition aggravated', 'Mastocytosis']",1,MODERNA,OT 1040535,CA,65.0,M,"Stroke (blood in the brain); heavy legs; not feeling himself; difficulty walking secondary to stroke; Bad Headache; A spontaneous report was received from a consumer concerning a 65-years-old, male patient who experienced bad headache, stroke (blood in the brain), difficulty walking secondary to stroke, heavy legs, and not feeling himself. The patient's medical history included atrial fibrillation (A-Fib) four years ago. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included blood thinners. On 10 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient experienced a headache. On 28 Jan 2021, he reported having a bad headache, heavy legs and was not feeling himself. On 29 Jan 2021, the patient was admitted to the hospital and was told he had a stroke (blood in the brain). Patient was discharged on 02 Feb 2021. He now has difficulty walking and is trying to walk with a walker and has to go to rehab. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The events bad headache, stroke (blood in the brain), difficulty walking secondary to stroke, heavy legs, not feeling himself and headache were resolved on 02 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Of note, patient's medical history of atrial fibrillation and concomitant use of blood thinners may have been contributory for hemorrhagic stroke.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/10/2021,01/11/2021,1.0,UNK,,,Medical History/Concurrent Conditions: AFib (A-Fib 4 years ago),,,"['Gait disturbance', 'Haemorrhagic stroke', 'Headache', 'Limb discomfort', 'Malaise']",1,MODERNA,OT 1040536,,,F,"slight anaphylaxis reaction; difficulty swallowing; swelling at the injection; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced slight anaphylaxis, difficulty swallowing and swelling at the injection. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. Patient called to inquire about the second dose. She stated she had a slight anaphylaxis reaction. When quired for more details regarding her event she mentioned that it was sort of difficulty swallowing, which didn't last long and some swelling at the injection. No treatment information was provided. Action taken with RNA-1273 in response to the event was unknown. The event difficulty in swallowing was considered as resolved. The outcome of the event slight anaphylaxis and swelling at the injection was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Anaphylactic reaction', 'Dysphagia', 'Injection site swelling']",1,MODERNA,OT 1040538,TN,50.0,M,"Significant cellulitis on his left shin and foot; Anorexia/lack of appetite; Abdominal pain; Diarrhea; Fever; Chills; Fatigue/frequently had to lay in bed; A spontaneous report was received from a physician concerning a 50-year-old, White, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, abdominal pain, anorexia/lack of appetite, diarrhea, fatigue/frequently had to lay in bed, and cellulitis on his left shin and foot. The patient's medical history was not provided. No concomitant medications were reported. On 31 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced fever, chills, abdominal pain, anorexia/lack of appetite, diarrhea, fatigue/frequently had to lay in bed, and cellulitis on his left shin and foot. The patient took paracetamol and naproxen for the events, which somewhat helped. Action taken with mRNA-1273 in response to the events was not provided. The events, fever, chills, abdominal pain, anorexia/lack of appetite, diarrhea, fatigue/frequently had to lay in bed, were considered resolved on an unknown date. The outcome for the event, cellulitis on his left shin and foot, was reported as not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Cellulitis of shin and foot is unlikely related to mRNA-1273.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Abdominal pain', 'Cellulitis', 'Chills', 'Decreased appetite', 'Diarrhoea', 'Fatigue', 'Pyrexia']",1,MODERNA,OT 1040539,MA,,U,"Bell's Palsy; Tongue started tingling; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's Palsy and tongue started tingling. The patient's medical history was not provided. No relevant concomitant medications were reported. On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, within two days after injection, the patient's tongue started tingling. On 23 Jan 2021, the patient spent 18 hours in the emergency room. Two MRIs (magnetic resonance imaging) and bloodwork were conducted, they confirmed the patient had Bell's Palsy on the left side of the face. On 27 Jan 2021, the patient's tongue began tingling again and had not resolved at the time of reporting. Treatment for the events was not provided. Action taken the second dose of mRNA-1273 in response to the events was not reported. The event, tongue started tingling, was reported as not resolved. The outcome for the event, Bell's Palsy, was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/22/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Blood test', 'Facial paralysis', 'Magnetic resonance imaging', 'Paraesthesia oral']",1,MODERNA,OT 1040540,,,F,"Major dementia type symptoms; A spontaneous report was received from a consumer concerning an elderly, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed some major dementia type symptoms/dementia. The patient's medical history was not provided. Concomitant medication history was not provided. On 03 Feb 2021, prior to the onset of the events, the patient received their dose of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. The reporter stated that the patient have been having some real major dementia type symptoms that were new for her (Onset date not provided). Treatment for this event was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, major dementia type symptoms/dementia was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's age is a risk factor and confounds causality assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No adverse event history),,,['Dementia'],UNK,MODERNA,OT 1040541,OH,85.0,F,"Debilitating Stroke; Affecting the left side of her body; A spontaneous report was received from a consumer concerning an 85-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced debilitating stroke (cerebrovascular accident), affecting the left side of her body (hemiplegia). The patient's medical history was not provided. No concomitant medications were reported. On 23 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 25 Jan 2021, the patient experienced debilitating stroke, affecting the left side of her body. Treatment information was not provided. The reporter stated that the patient was now in hospice care. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, debilitating stroke, affecting the left side of her body, was unknown.; Reporter's Comments: This case concerns a 85-year-old, female patient who experienced debilitating cerebrovascular accident and hemiplegia 3 days after the first dose of mRNA-1273 (Lot number: 029L20A). Very limited information regarding this event has been provided at this time. Further information regarding patient's medical history and comorbidities has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,01/25/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Cerebrovascular accident', 'Hemiplegia']",1,MODERNA,OT 1040542,IL,,M,"Psychosis; Pain in the back of eyes; Weakness; Chills; Muscle pains/ Myalgia; A spontaneous report was received from a consumer concerning a male patient of an unknown age who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed psychosis, pain in the back of his eyes, chills, myalgia, and weakness. The patient's medical history included schizoaffective bipolar disorder. Products known to have been used by the patient, within two weeks prior to the event, included paliperidone. The patient received their first of two planned doses of mRNA-1273 (batch number not provided) on 24 Dec 2020. On 21 Jan 2021, an unknown amount of time prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient received paliperidone. On an undisclosed date, the patient experienced pain in the back of his eyes, felt a chill, muscle pains, and weakness. The patient had been diagnosed with schizoaffective bipolar disorder and was missing at the time of the report. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable because the patient had received both doses. The outcome of the events psychosis, pain in the back of his eyes, chills, myalgia, and weakness, was not reported.; Reporter's Comments: This case concerns a male patient of an unknown age who experienced a medically important event of psychosis, and in addition non-serious events of pain in the back of his eyes, chills, myalgia, and weakness. Based on the current information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded, however the patient's history of schizoaffective bipolar disorder is a strong confounder for the event of psychosis. The case is lost to follow-up as Consumer did not give consent to follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,,,UNK,PALIPERIDONE,Bipolar disorder (Schizoaffective),,,,"['Asthenia', 'Chills', 'Eye pain', 'Myalgia', 'Psychotic disorder']",2,MODERNA,OT 1040545,NY,,F,"Neuropathy (tingling and burning in the feet and legs); A spontaneous report was received from a consumer, regarding herself, a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced neuropathy (tingling and burning in the feet and legs). The patient's medical history was not provided. Concomitant product use was not provided. On 13 Jan 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (lot number: unknown) for prophylaxis of COVID-19 infection. On 13 Jan 2021, after the first dose of mRNA-1273 vaccine, the patient noted neuropathy (tingling and burning in the feet and legs). Was inquiring whether this will recur after the second injection. Treatment information was not provided. Action taken with mRNA-1273 in response to event was not reported. The outcome of the event, neuropathy (tingling and burning in the feet and legs) was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,02/08/2021,26.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical history not provided),,,['Neuropathy peripheral'],1,MODERNA,OT 1040546,IL,,M,"bell's palsy; A spontaneous report was received from a healthcare professional (HCP) concerning a 56-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's Palsy/facial paralysis. The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the event, included valsartan, insulin, insulin degludec, rosuvastatin, and acetylsalicylic acid. On 12 Jan 2021, prior to the onset of the events, the patient received their dose of mRNA-1273 (lot number: 06L20A) intramuscularly in his left arm for prophylaxis of COVID-19 infection. The patient experienced Bell's Palsy on 25 Jan 2021. Treatments of these events were not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, Bell's Palsy/facial paralysis was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. .",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,02/06/2021,25.0,UNK,VALSARTAN; INSULIN; TRESIBA; ROSUVASTATIN; BABY ASPIRIN,,Medical History/Concurrent Conditions: No adverse event (No adverse event history),,,['Facial paralysis'],1,MODERNA, 1040547,TX,21.0,F,"Mini seizures; Body chills; A spontaneous report was received from a consumer, concerning herself, a 21-year-old female patient, who received Moderna's COVID-19 vaccine and experienced mini seizures and some chills. The patient's medical history reported includes seizures. Concomitant product use was not provided by the reporter. On 06-FEB-2021, prior to the onset of events, the patient received her second of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for the prophylaxis of covid-19 infection. On an unspecified date in Jan-2021, the patient received her first dose of vaccine and on 07-FEB-2021, a day after the second dose of vaccine, patient experienced some chills and mini seizures. Treatment information was not provided Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events, mini seizures and some chills were considered unknown at the time of this report.; Reporter's Comments: Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded, however, patient's history of seizure is a confounding factor that may a possible contributory role. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/06/2021,02/07/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Seizures,,,"['Chills', 'Seizure']",2,MODERNA,OT 1040548,WA,,F,"Injection site weakness; IInjection site feeling muscles are inflamed; Shoulders got stuck, couldn't move left arm; Whole body, jaw, neck, teeth were very sore; Feeling stiff; Tendons in the gums hurt / teeth feels it's going to fall out of head; Injection site itchiness; Exacerbation of Lupus; Serum sickness; Delayed hypersensitivity; Chills; Fatigue; Injection area tenderness; A spontaneous report was received from a nurse who was also a forty-seven-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced exacerbation of Lupus, delayed hypersensitivity, serum sickness, injection site itchiness , chills, fatigue, injection site weakness, injection site feeling muscles were inflamed, shoulders got stuck/ couldn't move arm, whole body, jaw, neck, teeth were very sore , tendons in gum hurt/ teeth feels it's going to fall out of head, feeling stiff, and injection area tenderness. The patient's medical history, as provided by the reporter, included Lupus. Concomitant medications reported included hydroxychloroquine sulfate. The patient received their first of two planned doses of mRNA-1273 (Batch number 037K20A) on 07 Jan 2021 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 07 Jan 2021, the patient experienced minor injection area tenderness, chill, and fatigue. On 09 Jan 2021, the injection area tenderness, chill, and fatigue resolved. On 15 Jan 2021, the patient experienced an exacerbation of lupus, delayed hypersensitivity, and serum sickness. On an undefined date, the patient's symptoms initially started at the injection site at the left deltoid as itchiness, weakness � feeling muscles were inflamed. Her shoulders got stuck, couldn't move left arm. Injection site was not red. Whole body, jaw, neck, teeth were very sore. The tendons in the gums hurt. The patient was now stiff but could move things and could eat. �Teeth still felt it's going to fall out of my head.' The patient had yellow fever vaccine in 2005 and had a similar reaction; she thought it was serum sickness. She also reported that she gets annual flu shot and tetanus/ diphtheria/ pertussis vaccines and never had issues with those. No treatment information was provided. Action taken with RNA-1273 in response to the event was unknown. The outcome of the events exacerbation of lupus, delayed hypersensitivity, serum sickness, injection site itchiness, injection site weakness, injection site feeling muscles were inflamed, shoulders got stuck/ couldn't move arm, whole body, jaw, neck, teeth were very sore, tendons in gum hurt/ teeth feels it's going to fall out of head, and feeling stiff, was unknown. The outcome of the events chills, fatigue and injection site tenderness, was resolved on 09 Jan 2021.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Additional information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,PLAQUENIL [HYDROXYCHLOROQUINE SULFATE],,Medical History/Concurrent Conditions: Lupus syndrome,,,"['Chills', 'Fatigue', 'Gingival pain', 'Hypersensitivity', 'Injection site muscle weakness', 'Musculoskeletal disorder', 'Musculoskeletal stiffness', 'Pain', 'Serum sickness', 'Systemic lupus erythematosus', 'Vaccination site inflammation', 'Vaccination site pain', 'Vaccination site pruritus']",1,MODERNA,OT 1040549,TX,,M,"Bleeding in his gut; A spontaneous report was received from a consumer, male patient of unknow age, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced bleeding in his gut (gastrointestinal haemorrhage). The patient's medical history was not reported. No concomitant medications were reported. On an unknown date, prior to the onset of event, the patient received their second planned dose of mRNA-1273 (batch number: unknown), for the prophylaxis of COVID-19 infection. On an unknown date, the patient stated that he was bleeding in his gut, but he had the symptoms before receiving the vaccine. The patient got disconnected during call and was unavailable during call back. No treatment medication information was provided Action taken with second dose of mRNA-1273 in response to the event was not applicable. The outcome of the event, bleeding in his gut, was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Gastrointestinal haemorrhage'],2,MODERNA, 1040551,CA,81.0,M,"nauseous; He's having some episodes of going on in his head almost like a headache, hard to explain what's going on; He's having some episodes of going on in his head almost like a headache, hard to explain what's going on; This is a spontaneous report from a contactable consumers (patient's wife and patient). An 81 year old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263), via an unspecified route of administration on 23Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included bleeding ulcer and stent put in my heart valve. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) and acetylsalicylic acid, clopidogrel bisulfate (CLOPID-AS [ACETYLSALICYLIC ACID;CLOPIDOGREL BISULFATE]). On an unspecifed date, the patient's wife reported that her husband: He's having some episodes of going on in his head almost like a headache, hard to explain what's going on. Also nauseous, with the heart specialist told him to take probiotics with his medicine. He was hospitalized on January 7-11. He is on 81mg low dose aspirin, Clopidogrel 75mg daily medication. Prior to that week before Nov2007 he had a reaction to the aspirin and was hospitalized because it gave him a bleeding ulcer. The patient was hospitalized for the events on an unspecified date. Outcome of the events was unknown.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/23/2021,,,UNK,BABY ASPIRIN; CLOPID-AS [ACETYLSALICYLIC ACID;CLOPIDOGREL BISULFATE],,Medical History/Concurrent Conditions: Stent placement; Ulcer bleeding,,,"['Feeling abnormal', 'Headache', 'Nausea']",UNK,PFIZER\BIONTECH, 1040552,MA,32.0,F,"experienced crippling lower abdominal pain followed by very very heavy bleeding and clotting; experienced crippling lower abdominal pain followed by very very heavy bleeding and clotting; experienced crippling lower abdominal pain followed by very very heavy bleeding and clotting; This is a spontaneous report from a contactable healthcare professional (patient). A 32-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration in the left arm on 05Jan2021 10:15 at a single dose for COVID-19 immunization at a hospital. Medical history included idiopathic hypersomnia and allergies to eggplant. The patient has no covid prior to vaccination. Concomitant medications included methylphenidate hydrochloride (CONCERTA), methenamine, levonorgestrel (MIRENA), propranolol hydrochloride (PROPRANOL) and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). The patient had no other vaccine in four weeks. The patient previously took cefazolin and levaquin and experienced allergies to both. The patient has a Mirena IUD and never get her period at all. Within 6 hours of her first Pfizer injection (02Feb2021 16:00), the patient experienced crippling lower abdominal pain followed by very very heavy bleeding and clotting. Resolved within 48 hours as quickly as it came and didn't occur with second dose 1 week out. The patient was not tested for Covid post vaccination. The events were not treated. The outcome of the events was recovered on 04Feb2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information and known drug profile it is unlikely that the reported events were causally related to BNT162B2. These are intercurrent conditions. A contributory role of the patient's Mirena IUD should be evaluated. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,02/02/2021,28.0,PVT,CONCERTA; METHENAMINE; MIRENA; PROPRANOL; VITAMIN C [ASCORBIC ACID],,Medical History/Concurrent Conditions: Fruit allergy; Idiopathic hypersomnia,,,"['Abdominal pain', 'Haemorrhage', 'Thrombosis']",1,PFIZER\BIONTECH, 1040553,CA,46.0,F,"Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: not available), via an unspecified route of administration on left arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Age at vaccination was 46 years. The patient was not pregnant at the time of vaccination. Medical history included food irritations. Concomitant medications included unspecified vitamins (received within 2 weeks of vaccination). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient experienced tongue swelling, difficulty swallowing, raised blood pressure, redness, body weakness on 01Feb2021 at 16:30. The events resulted in emergency room visit/ department or urgent care visit. The patient received breathing treatments and unspecified IV medication for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,SEN,,,Medical History/Concurrent Conditions: Food allergy,,,"['Asthenia', 'Blood pressure increased', 'Blood pressure measurement', 'Dysphagia', 'Erythema', 'Swollen tongue']",UNK,PFIZER\BIONTECH, 1040554,PA,16.0,F,"Went to sit down and passed out; felt dizzy; nausious/nausia; sweaty; sick feeling; as she was ghost white; bad headache.; This is a spontaneous report from a contactable other Health Professional reported for herself. A 16-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) via intramuscular on left arm on 02Feb2021 03:45 PM, at age of 16 years old at single dose for Covid-19 immunization. Patient was not pregnant at the time of vaccination. Medical history reported as allergies to medications, food, or other products was reported as none known. Prior to vaccination, patient was not diagnosed with COVID-19. Other medications the patient received within 2 weeks of vaccination included multivitamin and melatonin gummies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via intramuscular at left arm on 12Jan2021 03:45 PM for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported morning after vaccine 03Feb2021 08:00 patient was felt dizzy and nausious. Told her mom and her mom ran over as she was ghost white. Went to sit down and passed out. Patient experienced sweaty, nausia, sick feeling and bad headache. Patient went to the emergency room (ER), they gave fluids and blood work. No heart issues noted. Felt better around 3 hours after. Headache was bad and continued on 05Feb2021 (reported today). Also, still feel nausious and had to lay down. All events occurred on 03Feb2021 08:00 AM. Patient was recovering. It was reported the adverse event result in emergency room/department or urgent care. The seriousness criteria were reported as not serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Patient was received treatment for the adverse event included fluids and heart monitoring. The patient underwent lab tests and procedures which included blood work in Feb2021. Since the vaccination, patient had not been tested for COVID-19. Outcome of events bad headache and nauseous was not recovered, for felt dizzy, as she was ghost white, passed out, sweaty, sick feeling was recovering.; Sender's Comments: Based on the information provided and plausible temporal association, a contributory of the suspect drug to the reported events cannot be completely excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/03/2021,1.0,SEN,MELATONIN GUMMIES,,,,,"['Blood test', 'Dizziness', 'Headache', 'Hyperhidrosis', 'Loss of consciousness', 'Malaise', 'Nausea', 'Pallor']",2,PFIZER\BIONTECH,OT 1040555,NY,65.0,F,"chondritis or polychondritis; chondritis or polychondritis; my nose and right ear swelled up; my nose and right ear swelled up; dose number=1: administration date=28Dec2020/dose number=2: vaccine date=08Jan2021; dose number=1: administration date=28Dec2020/dose number=2: vaccine date=08Jan2021; This is a spontaneous report from a contactable nurse reported for herself. A 65-year-old female patient received the second dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number EJ1686) via intramuscular on 08Jan2021 into left arm at a single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID 19. The patient got allergies to bentyl, codein, flagyl and got Hx diverticulitis, ileitis, hypothyroid. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination included levothyroxine, metoprolol and diazepam. The patient previously took the first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number EK5730) via intramuscular on 28Dec2020 12:00 into left arm at a single dose for covid-19 immunisation. On 11Jan2021 04:00, the patient nose and right ear swelled up. On 05Feb2021, per ENT, it was chondritis or polychondritis. Refer to rheumatologist pending, for further diagnostics. The adverse event resulted in doctor or other healthcare professional office/clinic visit and received treatment included amoxicillin, labs drawn, then prednisone tx, more labs drawn, more prednisone prescribed on 05Feb2021. Since the vaccination, the patient has tested for COVID 19 named saliva test on 03Feb2021 and got negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information provided, it is unlikely that chondritis or polychondritis is unlikely related to suspect product. Case will be reassessed as and when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,SEN,LEVOTHYROXINE; METOPROLOL; DIAZEPAM,,Medical History/Concurrent Conditions: Diverticulitis; Ileitis; Thyroid function decreased,,,"['Chondritis', 'Ear swelling', 'Ear, nose and throat examination', 'Inappropriate schedule of product administration', 'Nasal oedema', 'Off label use', 'Polychondritis', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1040556,CO,71.0,F,"Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; red flush to skin on the face; left neck & shoulder pain; left neck & shoulder pain/ hip pain; fatigue; Very disoriented; BP 182/98, elevated for me; Felt extremely unwell; This is a spontaneous report from a contactable other HCP reported for self. This 71-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 14:00 on Arm left at single dose (Lot # EK4176) for covid-19 immunisation. Medical history included Codeine experienced upset stomach only, Osteoporosis, nothing else ongoing. No covid prior vaccination. No other medications in two weeks. No other vaccine in four weeks. Within 6 minutes of injection had lightheadedness & difficulty breathing. This was followed by red flush to skin on the face. Within the next hour, left neck & shoulder pain, hip pain and fatigue. Very disoriented and BP 182/98, elevated for the patient, felt extremely unwell all on 28Jan2021. Over the next week, BP low 90/62 Pulse 58 intermittently in Feb2021. Doctor or other healthcare professional office/clinic visit, Prolongation of existing hospitalization. No covid tested post vaccination. No treatments received. Outcome of the events was not recovered.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 (COMIRNATY) to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,PVT,,Osteoporosis (nothing else ongoing),,,,"['Arthralgia', 'Blood pressure increased', 'Blood pressure measurement', 'Disorientation', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Flushing', 'Heart rate', 'Hypotension', 'Malaise', 'Neck pain', 'Pulse abnormal']",1,PFIZER\BIONTECH, 1040557,AZ,,M,"pneumonia; something wrong with his kidneys; dry heaves; he won't eat; had dots all over his back like it had exploded; rash; got sick; rash/ got sick; This is a spontaneous report from a contactable consumer. This consumer (wife) reported for a male patient (husband) that a male patient of an unspecified age received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 and got sick and rash. The reporter's husband had second shot and she knew he broke out in a red rash all over. He had the first one and got sick eight days later. He had been in the hospital. He saw his primary doctor when he got out of the hospital. He had dry heaves and he won't eat. He didn't want to drink any liquid. She was trying to make him drink. He didn't have a fever. His temp was 97.2. He might have had the rash with both doses. When he came home from the hospital he had a rash, but yesterday he was broken out all over. He got sick and had a test and didn't have it. It was on the twenty eighth when she put him in the hospital and he had pneumonia and something wrong with his kidneys. He was on an antibiotic. He got a rash anytime of the year. When he came home he had dots all over his back like it had exploded. She wanted to know if he could be allergic to this. The patient was hospitalized for the events pneumonia and something wrong with his kidneys. Treatment was received for the events pneumonia and something wrong with his kidneys. The outcome of the events was unknown. Information about Lot/Batch number is requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,"['Body temperature', 'Disease recurrence', 'Feeding disorder', 'Macule', 'Malaise', 'Pneumonia', 'Rash', 'Renal disorder', 'Retching']",2,PFIZER\BIONTECH, 1040558,ND,71.0,F,"Shoulders, ankles, elbows and everything were all hot with flare ups; markers for ESR, and CR were more than double what they should be; markers for ESR, and CR were more than double what they should be; 5 days after, I started feeling soreness and it has got progressively worse; 5 days after, I started feeling soreness and it has got progressively worse; This is a spontaneous report from a contactable Nurse, the patient. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL8982), via an unspecified route of administration on 13Jan2021 (at the age of 71-years-old) as a single dose for COVID-19 vaccination and started to receive methotrexate (ACCORD HEALTHCARE, lot number unknown, expiration date 12Nov2021) on an unspecified date (reported as seven years ago) at a dose of 17.5 mg weekly (seven tablets once a week) for Rheumatoid Arthritis. Medical history included rheumatoid arthritis from an unspecified date. Historical vaccinations included ""every vaccine known. I've had all my vaccines, flu whatever"" (as reported) on unspecified dates. It was unknown if the patient had received any other vaccinationa in the fourteen days prior to this inoculation. Concomitant medications included folic acid (MANUFACTURER UNKNOWN). On 18Jan2021 (reported as about five days after the shot), the patient had just a little soreness and she thought that was one of the side effects that you have that with the vaccine. So, she didn't worry so much about it. But then it got progressively worse. And by the time just before she was supposed to get the second shot, it was really bad. But she thought that she was still going to get that second shot which was planned for ""02Feb2021 or 03Feb2021"" (also reported as on 02Feb2021) because she didn't want to not get it. She was struggling with the pain before she got the second one. She mentioned that by the time she got her second dose, she was in an RA flare. She continued by saying that she had her blood work done, ""on Tuesday morning"" because she was due for her RA exam in Mar and it was due, and her markers for ESR, and ""CR whatever"" were more than double what they should be. Her Rheumatololgist saw her and when she went to the doctor her shoulders, her ankles, her elbows and everything were all hot with flare ups. Treatment included Prednisone 10mg every day which was given, according to the patient, in order to ""calm down my joints and everything."" The action taken with methotrexate was not reported. The clinical outcomes Rheumatoid Arthritis flare up, pain, condition aggravated, ESR increased and CRP increased were reported as unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Rheumatoid arthritis flare up, ESR increased, and CRP increased cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/01/2021,,UNK,FOLIC ACID,,Medical History/Concurrent Conditions: Rheumatoid arthritis,,,"['C-reactive protein increased', 'Condition aggravated', 'Pain', 'Red blood cell sedimentation rate increased', 'Rheumatoid arthritis']",UNK,UNKNOWN MANUFACTURER,OT 1040559,NC,,F,"cataract surgery; This is a spontaneous report from a contactable consumer via a Pfizer Sponsored program. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient scheduled next week for the 2nd dose of the vaccine on Friday. Will have a cataract surgery that needs Pre-Covid Test 2 days after the 2nd dose. Outcome was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Cataract'],1,PFIZER\BIONTECH, 1040560,,,M,"Diarrhea with bloody discharge; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer. A male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Feb2021 at SINGLE DOSE for Covid vaccine. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea with bloody discharge. The outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,,,UNK,,,,,,['Diarrhoea haemorrhagic'],1,PFIZER\BIONTECH, 1040561,CT,,F,also suffers from Narcolepsy; fatigue; moderate body aches; This is a spontaneous report from a contactable consumer reported for self. This 23-year-old female consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunisation. She experienced fatigue and moderate body aches. She also suffers from Narcolepsy and takes Xywav nightly. Outcome of the events was unknown. Information on lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Fatigue', 'Narcolepsy', 'Pain']",1,PFIZER\BIONTECH, 1040562,PA,33.0,F,"Sudden never hearing loss; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EJ1685), via an unspecified route of administration at the left arm on 20Jan2021 10:00 at single dose for COVID-19 immunization. The vaccine was administered in the hospital. The patient medical history was not reported. The patient was not pregnant. There was no other vaccine in four weeks. Prior to vaccination the patient had no COVID. The patient has not tested for COVID post vaccination. Concomitant medication included fluoxetine hydrochloride (PROZAC) and hctz. On 21Jan2021, the patient experienced sudden never hearing loss. It was reported that the event resulted to doctor or other healthcare professional office/clinic visit and Disability or permanent damage. The patient received an oral steroid as treatment. The outcome of the event was not recovered.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, a possible contributory role of the suspect BNT162B2 in triggering the onset of sudden never hearing loss cannot be excluded. Additional information regarding relevant medical history, etiologic and diagnostic work-up will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/20/2021,01/21/2021,1.0,PVT,PROZAC; HCTZ,,,,,['Deafness'],1,PFIZER\BIONTECH, 1040563,NY,,M,"Lost consciousness; possibly had a seizure; tingling in his hands; unable to speak; felt dizzy; was tired afterwards; felt sick; This is a spontaneous report from a contactable physician. A 27-year-old male patient started to received dose 2 bnt162b2 (UNSPECIFIED TRADE NAME), via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received BNT162B2 first dose on unspecified date with unspecified lot and expiration date. The patient reported at 4:30 after second dose of vaccine lost consciousness for 15 seconds on an unspecified date, possibly had a seizure on an unspecified date, tingling in his hands on an unspecified date at 9:00 in the evening, unable to speak on an unspecified date for 15 seconds, felt dizzy on an unspecified date, was tired afterwards for about 2 hours on an unspecified date, and felt sick on an unspecified date. Outcome of event Lost consciousness was recovered, possibly had a seizure was unknown, tingling in his hands recovered, unable to speak was recovered, felt dizzy was unknown, was tired afterwards recovered, and felt sick was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the seizure, LOC and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, serum toxicology screen, chemistry panel and EEG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Dizziness', 'Fatigue', 'Loss of consciousness', 'Malaise', 'Paraesthesia', 'Seizure', 'Speech disorder']",2,PFIZER\BIONTECH, 1040564,MD,41.0,M,"Tonic clonic seizure; This is a spontaneous report from a contactable physician. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 01Feb2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tonic clonic seizure on 01Feb2021, the same day. The patient received the dose at 14:00 and had the seizure around 19:00. Patient has recovered from the event on an unspecified date. No treatment was received for the event. Information about lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tonic clonic seizure and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,UNK,,,,,,['Generalised tonic-clonic seizure'],UNK,PFIZER\BIONTECH, 1040565,KS,81.0,M,"does have a compromised immune system and he is given Bivigam via IV on a monthly basis; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient receive BNT162B2 (reported as COVID-19 vaccine, unspecified manufacture, lot/batch number and expiration date were unknown) via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He got to a second and noticed something. He had a compromised immune system and he was given immunoglobulins human normal (Bivigam) via intravenous on a monthly basis. Patient wondering if this is okay with the vaccine. The outcome of event was unknown. Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities. Information on batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,,,UNK,,,,,,['Immunodeficiency'],UNK,PFIZER\BIONTECH, 1040566,GA,65.0,F,"Blood in stool; Stomach discomfort; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech, Lot# FL9264), via an unspecified route of administration, on 04Feb2021 at 13:00, at single dose, for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. Patient did not have vaccinations within 4 weeks prior. The patient experienced blood in stool and stomach discomfort both on 05Feb2021 with outcome of recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Abdominal discomfort', 'Haematochezia']",1,PFIZER\BIONTECH, 1040567,,25.0,F,"Arrhythmia; Tachycardia, BP 103/min; This is a spontaneous report from a contactable other HCP. A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264) on 05Feb2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. The patient received first dose of BNT162B2 on 14Jan2021 at 03:45 pm on left arm. Concomitant medications were not reported. On 05Feb2021 at 15:00 the patient experienced Tachycardia with BP 103/min and Arrhythmia. No treatment was given for reported events. At the time of the reporting the patient had not yet recovered from the events. The information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event arrhythmia with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,SCH,,,,,,"['Arrhythmia', 'Heart rate', 'Tachycardia']",2,PFIZER\BIONTECH, 1040568,,,M,"he fell and was in the hospital; This is a spontaneous report from a contactable consumer reporting for her husband. A male patient of an unspecified age received the first dose of bnt162b2 (BNT162B2) , via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient fell and was in the hospital on an unspecified date with outcome of unknown. The reporter is wondering how long can the patient wait before he gets the second dose without having to restart Information about batch/lot number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,['Fall'],1,PFIZER\BIONTECH, 1040606,CA,49.0,M,L external cephalic phlebitis,Not Reported,,Not Reported,Not Reported,,Yes,N,01/07/2021,01/07/2021,0.0,PVT,"Paxil,nortryptoline,minicylcine",No,Migraines,,"Compazine,raglan","['Angiogram', 'Computerised tomogram thorax', 'Phlebitis', 'Ultrasound scan']",2,PFIZER\BIONTECH,IM 1040633,CA,52.0,F,Death due to hemorrhagic stroke.,Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/06/2021,7.0,PUB,"Levothyroxine 100mcg, one tablet daily",,"Hypothyroidism, recent hypertension",,,"['Computerised tomogram', 'Death', 'Haemorrhagic stroke']",1,MODERNA,IM 1040646,NY,35.0,F,"About 2 hours after injection tongue started swelling, became difficult to breath, mouth and throat started tingling, started blacking out. Chewed 2 benadryl and went to emergency room. Was given more antihistamines there and monitored until reaction stopped.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,MIL,None,None,None; obese,anaphylactic reaction to MMR vaccine given in 2016. Also needed to go to ER at that time. Age 31.,"shellfish, latex, gluten intolerance. Have had prior anaphylactic reaction to MMR vaccine, other vaccines seem to be fine.","['Blood test', 'Dyspnoea', 'Electrocardiogram normal', 'Loss of consciousness', 'Paraesthesia oral', 'Pharyngeal paraesthesia', 'Swollen tongue']",1,MODERNA,SYR 1040673,OH,79.0,F,"laid on the floor and does not know if passed out on the floor or fell asleep (thinks could not have fallen asleep with such a pain); horrible pain on left side (side of the injection); awful pain on left leg; could not raise leg; congestion in head, like a sinus infection; tiredness/fatigue; Headache; Chills; A spontaneous report was received from a consumer, a 79-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced laid on the floor and does not know if passed out on the floor or fell asleep (thinks could not have fallen asleep with such a pain), horrible pain on left side (side of the injection), headache, chills, tiredness/fatigue, awful pain in leg, could not raise leg, and congestion in head, like a sinus infection. The patient's medical history was not provided. Her allergies included sulfa, mycin, meloxicam and glycopyrrolate. Concomitant medications included blood pressure medication (name not reported). On 28 Jan 2021, approximately one day prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (Batch number: 028L20A) on the left side (anatomical location not reported) for prophylaxis of COVID-19 infection. On 28 Jan 2021, on the night of the vaccination, the patient woke up with a horrible pain one her left side (side of the injection), headache, chills, fatigue/tiredness, an awful pain on her leg, and congestion in her head, like a sinus infection. She got up thinking that walking would make the pain on her leg go away, but it did not. When the patient tried to go back to bed, she could not raise her leg so she laid on the floor and she did not know if she passed out on the floor or fell asleep (she thought she could not have fallen asleep with such pain). When the patient woke up, she could move her leg normally. Treatment information was not provided. Action taken in response to the events was unknown. The events, laid on the floor and does not know if passed out on the floor or fell asleep (thinks could not have fallen asleep with such a pain), horrible pain on left side (side of the injection), headache, chills, awful pain in leg, could not raise leg, and congestion in head, like a sinus infection were considered resolved on 29 Jan 2021. The event, fatigue/tiredness was considered not recovered/not resolved.; Reporter's Comments: This case concerns a 79 year old female subject, who experienced a serious unexpected event of loss of consciousness after first dose of mRNA1273 (Lot# 028L20A). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,UNK,,Allergy to antibiotic (mycin); Drug hypersensitivity (Robinul); Drug hypersensitivity (Mobic); Sulfonamide allergy,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Chills', 'Fatigue', 'Headache', 'Loss of consciousness', 'Muscular weakness', 'Pain', 'Pain in extremity', 'Sinus congestion']",1,MODERNA,OT 1040674,NY,,M,"Completely lost hearing; Scratchy throat; A spontaneous report was received from a consumer (patient's wife), concerning an 80 years-old male patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced completely lost hearing and scratchy throat"". The patient's medical history included had partial hearing loss before the Moderna dose. Concomitant medications reported included were losartan, pantoprazole, unspecified prostate medication, cholesterol medication, heart disease, and arrhythmia medication. On 29 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: 012L20A), administered in the left arm for the prophylaxis of COVID-19 infection. On an unknown date, the patient experienced scratchy throat and completely lost hearing (had partial hearing loss before the Moderna dose) and was beginning to hear a bit. The patient did not take any medication to treat symptoms. The consumer was very much concerned because of hearing loss and asked if patient should receive the second dose of Moderna vaccine. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of the events completely lost hearing is resolving and scratchy throat were reported as unknown.; Reporter's Comments: Very limited information regarding the reported events has been provided at this time. onset duration is lacking for the events Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,,,UNK,LOSARTAN; PANTOPRAZOLE,,Medical History/Concurrent Conditions: Partial hearing loss,,,"['Deafness', 'Throat irritation']",1,MODERNA,OT 1040675,TX,29.0,F,"Arm is sore at the injection site; Had thoughts of killing myself; Had a psychotic episode; A spontaneous report was received from a consumer concerning a 29-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced psychotic episode and arm is sore at the injection site. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 03 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 013M20A] intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 03 Feb 2021, the patient experienced a psychotic episode after the vaccination in which she had thoughts of killing herself and other people. Treatment information was not provided. She reported that it happened once before in March 2020 when her epilepsy medication was not at the correct dose. On 04 Feb 2021, the patient reported that her arm was sore at the injection site. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events psychotic episode and arm is sore at the injection site was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history); Suicidal ideation,,,"['Psychotic disorder', 'Suicidal ideation', 'Vaccination site pain']",1,MODERNA,OT 1040715,KY,72.0,M,"1st Vaccine 1/27/21; 2nd Vaccine 2/17/21; presented to ED 2/17/21 with c/o bodyaches, elevated BP, generalized weakness, palpitations, and headache; onset 2/17/21 several hours after 2nd dose vaccine 2/17/21. Admitted to hospital from ED 2/17/21 with elevated troponin.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/17/2021,02/17/2021,0.0,PVT,,,multiple; refer to chart,,Amlodipine; Rifabutin,"['Asthenia', 'Blood pressure increased', 'Headache', 'Pain', 'Palpitations', 'Troponin increased']",2,PFIZER\BIONTECH,IM 1040728,NJ,31.0,F,"Syncope with head injury, concussion, chin laceration. At 4AM when walking back from the bathroom, suddenly syncopized with head strike on the floor. Subsequently required 6 stitches in the emergency room for her chin. Required CT head/neck and MRI head as well as she was confused and had amnesia.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/15/2021,02/16/2021,1.0,PVT,None.,None.,NOne.,,None.,"['Activated partial thromboplastin time', 'Amnesia', 'Computerised tomogram head', 'Computerised tomogram neck', 'Concussion', 'Confusional state', 'Full blood count', 'Head injury', 'Human chorionic gonadotropin', 'International normalised ratio', 'Magnetic resonance imaging brain', 'Metabolic function test', 'Prothrombin time', 'Skin laceration', 'Syncope', 'Urine analysis']",2,MODERNA, 1040745,GA,69.0,F,"1. Pain and soreness in my muscles, bones and joints in all parts of my body. 2. It is difficult to move without pain and discomfort. 3. ""Brain Fog"" I am unable to remember names, exact dates. 4. Repeating the same information. 5. Irritability, moodiness - mood disorders.",Not Reported,,Not Reported,Not Reported,,Yes,U,01/16/2021,01/16/2021,0.0,PUB,Losartan-HCTZ - 100-25 MG,"1. Myocosis Fungoids - skin cancer, 2. sleep apnea","Good, with the above problems listed in item #11.",,Topical Iodine,"['Affective disorder', 'Arthralgia', 'Bone pain', 'Discomfort', 'Feeling abnormal', 'Irritability', 'Myalgia', 'Pain', 'Repetitive speech']",1,MODERNA,IM 1040770,KY,84.0,U,"1st vaccine 2/6/21; developed altered speech, drooling, nausea, vomiting 2/17/21; seen at ED 2/18/21 and admitted to hospital for stroke symptoms",Not Reported,,Not Reported,Yes,,Not Reported,U,02/06/2021,02/17/2021,11.0,PVT,,,Multiples; see chart,,PCN; Sulfa Abx; Amoxil; Hydrochorothiazide,"['Drooling', 'Dysarthria', 'Nausea', 'Neurological symptom', 'Vomiting']",1,PFIZER\BIONTECH,IM 1040778,LA,84.0,M,Thrombocytopenia,Not Reported,,Yes,Yes,,Not Reported,U,02/11/2021,02/12/2021,1.0,PVT,"Albuterol, allopurinol, atorvastatin, losartan, metoprolol succinate, Tamsulosin","Epistaxis 1/19/2021 requiring ED visit, no CBC at that time","Hypertension, CKD stage 3, Hyperlipidemia. BPH, Gout, Macular degeneration",,Diclofenac,['Thrombocytopenia'],1,MODERNA,IM 1040801,,40.0,M,"Pneumonia; difficult time breathing; A spontaneous report was received from a health care professional concerning a 40-year-old male patient who was administered Moderna's COVID-19 vaccine and experienced having a difficult time breathing (dyspnea) and pneumonia. The patient's medical history included autism and mental retardation. Concomitant product use was not provided by the reporter. On 18 Jan 2021, approximately 2 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. On 20 Jan 2021 early in the morning, the patient had a difficult time breathing. Around 17:00 the patient was taken to the emergency room and was given 10 liters of oxygen. The patient was admitted to the hospital. On 22 Jan 2021 everything cleared suddenly, so the patient was able to leave the hospital. The patient was diagnosed with pneumonia. The reporter indicated the patient did not have a history of lung problems, so she was concerned and wanted more information on what happened. Treatment for the event included 10 liters of oxygen. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, having a difficult time breathing and pneumonia, were considered recovered/resolved on 22 Jan 2021.; Reporter's Comments: This case concerns a 40 year old male subject, who experienced a serious unexpected event of pneumonia after first dose of mRNA1273 (Lot# unknown). Very limited information has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/18/2021,01/20/2021,2.0,UNK,,Autism; Mental retardation,,,,"['Dyspnoea', 'Pneumonia']",1,MODERNA,OT 1040802,OH,88.0,F,"Toileting and had expired while doing so; Severe abdominal pain; Diarrhea; Vomiting; Mild injection site pain; A spontaneous report was received from a healthcare professional concerning an 88-year-old , female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, toileting and had expired while doing so (death), mild injection site pain, severe abdominal pain, diarrhea, and vomiting. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient felt mild pain at the injection site after receiving the vaccine. On 21 Jan 2021, the patient reported severe abdominal pain, diarrhea and vomiting. These symptoms were intermittent for a week and no other adverse events were noted. On 27 Jan 2021, the patient passed away while toileting. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 27 Jan 2021. The cause of death was unknown. An autopsy was not performed.; Reporter's Comments: The gastrointestinal events were consistent with increased risk associate with elderly age of patient. The cause of death was unknown. Autopsy was not performed. Very limited information regarding the events is available at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death",Yes,01/27/2021,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Abdominal pain', 'Death', 'Diarrhoea', 'Injection site pain', 'Vomiting']",1,MODERNA,OT 1040803,AL,79.0,M,"Bell's Palsy; .A spontaneous report was received from a consumer who was also a 79 years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced Bell's palsy (facial paralysis). The patient's medical history was not provided. Concomitant medication reported included metformin. On 29 Jan 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: 012L20A), intramuscularly for the prophylaxis of COVID-19 infection. On 29 Jan 2021, after the administration of vaccine, the patient developed Bell's palsy. The patient went to the emergency room (ER) for treatment but was unable to get the condition resolved. The patient was referred to a neurologist, but the side effects were still present up to this point. Action taken with second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, Bell's palsy, was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,UNK,METFORMIN,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Facial paralysis'],1,MODERNA,OT 1040817,KS,28.0,F,"Arm started swelling within five minutes. Arm was turning red, itchy and burned. Neck and chest started turning red, itchy and burning, then spread up left side of face. Started coughing, throat itched, was really dizzy. Nurse sat next to me with an Epi-Pen for a few hours.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,WRK,"Lamictal, K-Dur, hydrochlorothiazine, BuSpar, Benadryl, Proventil, Advair.",,"Epilepsy, migraines, hypokalemia, hypertension, asthma.","COVID19 (Moderna), first dose. Aged 28, 01/08/2021, anaphylaxis.","Shellfish, peanuts, white fish, latex, morphine, cilantro, aspirin.","['Burning sensation', 'Cough', 'Dizziness', 'Erythema', 'Peripheral swelling', 'Pruritus', 'Throat irritation']",2,MODERNA,SYR 1040819,IN,72.0,F,"2/11 Flu like symptoms all day, 2/12 severe pain upper right quadrant, nausea, went to ER, admitted and put on saline drip until 2/15, pancreatitis treatment. taken off drip Monday 2/15, sent home with instructions to follow up with GI specialist and low fiber diet.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/13/2021,02/11/2021,29.0,PVT,"Propanolol, fluoxitine, prempro, lunesta, aspirin, imodium, vit D,",none,none,,"E-myacin, colace","['Abdominal pain upper', 'Blood test', 'Computerised tomogram', 'Influenza like illness', 'Nausea', 'Pancreatitis', 'X-ray with contrast lower gastrointestinal tract']",2,MODERNA,IM 1040844,OH,71.0,M,"1/30/2021 Began with spiking BP and extreme pain in right shoulder - taken to ER. Given pain med, BP came down and sent home. 2/2/2021 - Spiking BP and chest pain, numbness and tingling in hands and feet. - taken to Medical Center. Admitted. Series of heart and brain assessments done. Each day he got weaker until he could no longer stand, walk, arm and hand strength depleted and dexterity issues. Spinal Tap on 2/8/2021 revealed Guillain Barre Syndrome 2/12 Admitted to Rehabilitation Center, 2/15 at Hospital plummeting BP, 2/18 return to Rehabilitation Center",Not Reported,,Yes,Yes,11.0,Not Reported,N,01/16/2021,01/30/2021,14.0,PVT,Lisinopril 40 mg tablet Hydrochlorothiazide 25 mg tablet asprin 81 mg Glucosamine JCL 1500 with MSM 600+D3 Calcium a,None,Elevated BP - Nothing else,,None,"['Asthenia', 'Blood potassium decreased', 'Blood pressure fluctuation', 'Blood sodium decreased', 'Blood test normal', 'CSF protein increased', 'Chest pain', 'Computerised tomogram normal', 'Dysstasia', 'Echocardiogram normal', 'Electrocardiogram normal', 'Electroencephalogram normal', 'Fine motor skill dysfunction', 'Gait inability', 'Guillain-Barre syndrome', 'Hypoaesthesia', 'Injection site pain', 'Lumbar puncture', 'Magnetic resonance imaging normal', 'Muscular weakness', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 1040851,MI,68.0,M,7:30 the night after the vaccine he got very lethargic and dizzy. And about thirty minutes later he couldn't he lift his right arm or right leg. He was extremely dizzy and not completely coherent. I took him to the hospital where they ran CAT scans and labeled it a TIA.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/02/2021,02/03/2021,1.0,PHM,nemenda fish oil vitamin C donpretzole tumeric ibuprofen (as needed),None,Alzheimer's,,seasonal allergies,"['Blood test', 'Computerised tomogram abnormal', 'Dizziness', 'Echocardiogram', 'Incoherent', 'Lethargy', 'Magnetic resonance imaging', 'Mobility decreased', 'Transient ischaemic attack']",1,PFIZER\BIONTECH,SYR 1040874,MN,65.0,M,"Within one week of receiving vaccine, experienced shortness of breath and chest tightness on exertion, lightheadedness, tachycardia. Became increasing worse over next 5 days. Visit to ER on 1/18/21. Diagnosed with many bilateral pulmonary emboli with clots in both pulmonary arteries. Admitted to hospital and started on Eliquis. Had doppler on legs which showed DVT.",Not Reported,,Yes,Yes,1.0,Not Reported,N,01/30/2021,02/06/2021,7.0,SCH,"Cardizem, zoloft, Lipitor, Baby aspirin","Hypertension, High Cholersterol",Chronic back pain. Previous back surgeries. Had provoked blood clot after back surgery in 2004,,None,"['Chest discomfort', 'Computerised tomogram thorax', 'Deep vein thrombosis', 'Dizziness', 'Dyspnoea exertional', 'Echocardiogram', 'Pulmonary embolism', 'Scan with contrast', 'Tachycardia', 'Ultrasound Doppler', 'Ultrasound Doppler abnormal', 'Ultrasound scan']",1,PFIZER\BIONTECH,IM 1040877,HI,58.0,F,"unknown if related to vaccine. patient received 2nd vaccine at 0830, observed 15 minutes, discharged, arrested at 0915 upon entering her home. vaccine was administered by DOH at their community location. patient was pronounced lifeless in the ED.",Yes,02/18/2021,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,PVT,"wellbutrin, crestor, albuterol, deltasone, cozaar, spiriva, coreg","chest pain, COPD, Bipolar, dyslipidemia, stage 3 chronic kidney disease",as above,,penicillin,"['Cardiac arrest', 'Death']",UNK,MODERNA, 1040878,PA,90.0,F,Patient went unresponsive and died a few days later,Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/20/2021,2.0,SEN,,,,,NKA,"['Death', 'Unresponsive to stimuli']",UNK,UNKNOWN MANUFACTURER, 1040887,NH,49.0,M,Severe multi system adverse reaction including heart attack within 5 minutes of vaccine.,Not Reported,,Yes,Yes,3.0,Yes,N,01/22/2019,01/22/2021,731.0,WRK,none,none,,,none,"['Laboratory test', 'Multi-organ disorder', 'Myocardial infarction']",UNK,MODERNA,SYR 1040918,FL,,M,"Acute pericarditis; Soreness on the left shoulder (injection site); A spontaneous report was received from a consumer who was also a 75-years-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced soreness on the left shoulder (injection site)/ injection site soreness and acute pericarditis/ pericarditis. The patient's medical history was not provided. Concomitant medications were not reported. On 16 Jan 2021, seven days prior to onset of the events, the patient received their first two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly for the prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient experienced soreness on the left shoulder (injection site), tiredness, headache, and chest pain. On 02 Feb 2021, he had difficulty breathing even with his continuous positive airway pressure (CPAP) machine and called 911. He was taken to emergency room (ER) and was diagnosed with acute pericarditis. Treatment included ibuprofen, pantoprazole, and colchicine. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, soreness on the left shoulder (injection site and acute pericarditis, was not reported.; Reporter's Comments: This case concerns a 75 year old male subject, who experienced a serious unexpected event of Pericarditis and a non-serious expected event of injection site pain after first dose of mRNA1273 (Lot# 039K20A). Very limited information has been provided regarding the event of pericarditis at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,01/23/2021,7.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Injection site pain', 'Pericarditis']",1,MODERNA,OT 1040919,KY,90.0,M,"Hypoxic failure secondary to acute on chronic diastolic heart failure; Shortness of breath; Weak; Tired; A spontaneous report was received from a healthcare professional concerning a 90-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypoxic failure secondary to acute on chronic diastolic heart failure, shortness of breath, tired, and weak. The patient's medical history, as provided by the reporter, included chronic diastolic heart failure. Concomitant product use was not provided. On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A), intramuscularly for prophylaxis of COVD-19 infection. On 16 Jan 2021, the patient had shortness of breath, was tired and weak. He was taken to the hospital and diagnosed with hypoxic failure secondary to acute on chronic diastolic heart failure. Treatment for the events included intravenous (IV) bumetanide. The patient was discharged home with oxygen on an unknown date. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, hypoxic failure secondary to acute on chronic diastolic heart failure, shortness of breath, tired, and weak, was unknown.; Reporter's Comments: Based on the diagnosis of hypoxic failure secondary to acute on chronic diastolic heart failure provided by the hospital, the event is assessed as unlikely related to mRNA-1273. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/15/2021,01/16/2021,1.0,UNK,,Chronic diastolic heart failure,,,,"['Asthenia', 'Dyspnoea', 'Fatigue', 'Respiratory failure']",1,MODERNA,OT 1040922,FL,41.0,F,"Cold and clammy; Fever of 104 F; Injection site pain; Headache; Muscle pain; Chills; Joint Pain; Fatigue; Nausea; Hallucinations; Tachycardia; Felt Unwell; A spontaneous report was received from a healthcare professional, concerning a 41-year-old, female patient, who received Moderna's COVID-19 vaccine and experienced hallucinations, injection site pain, headache, muscle pain (arthralgia), chills, joint pain, fever of 104 F (pyrexia) with fatigue, nausea, felt unwell (malaise), tachycardia and felt cold and clammy. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) unknown route of administration on unknown date. On 05 Feb 2021 at 10:00 am prior to the onset of the events, patient received their second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. On 05 Feb 2021, approximately at 18:00 patient developed injection site pain, headache, muscle pain, chills, joint pain, fever of 104 F with hallucinations, fatigue, nausea, felt unwell, tachycardia and felt cold and clammy. On 08 Feb 2021, patient was cold and clammy and heart rate was 110-120 bpm. Patient treated symptoms at home. No treatment information was provided. Consent for safety follow up was given. The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of the event, experienced injection site pain, headache, chills, joint pain, fever of 104 F with hallucinations, fatigue, nausea, felt unwell, tachycardia and felt cold and clammy were unknown. On 08 Feb 2021, The event, muscle pain considered resolved.; Reporter's Comments: This case concerns a 41 year old, female patient, who experienced a serious unexpected event of Hallucination after receiving second dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Arthralgia', 'Chills', 'Cold sweat', 'Fatigue', 'Hallucination', 'Headache', 'Heart rate', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia', 'Tachycardia', 'Vaccination site pain']",1,MODERNA,OT 1040925,,,M,"Patient died from a flu shot; Initial information was received on 12-Feb-2021 regarding an unsolicited valid serious case from a consumer or non-health care professional via social media. This case involves a male patient (age unspecified) who died (death), after he received INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination. On an unknown date, the patient died (death), (unknown latency) following the administration of INFLUENZA VACCINE. This event was also assessed as medically significant. It was unknown if the patient experienced any additional symptoms/events before death. It was unknown if there were laboratory data/results available. It was not reported if the patient received any corrective treatment before death. It was unknown if an autopsy was done. The cause of death was not clearly specified (patient was died from flu shot). At the time of reporting it was reported that, product name was not provided and it was reported via public post on the Sanofi flu shot campaign hence reporter assumed that the consumer was referring to the Sanofi flu vaccine. There will be no information available on the batch number for this case.; Sender's Comments: This was a poorly documented social media case received from involved a male patient (age unspecified) who died (death) after administration of INFLUENZA VACCINE. The time to onset is unknown. Further information regarding medical history, concomitant disease or risk factor, concurrent condition during vaccination, previous vaccination and tolerance, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient died from a flu shot",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],UNK,UNKNOWN MANUFACTURER,OT 1040927,NY,86.0,F,"Patient previously had dizzy spills, but about a week after receiving the vaccine her dizzy spills began to get worse. The whole prior she kept saying I am just not right. On the 2/7/21 she a COVID test done, a nurse came to her house and preformed. On the morning of the 8th patient was on the phone with someone else and patient asked this person to call me and go check on her. Within 5 minutes I was over at her house, and I found her on the floor, she on her belly facedown. It looked like she was on the toilet, and it looked like she fall getting her off, she was still wet, she still felt warm. I called the ambulance and immediately began CPR. When EMS arrived they took over the CPR and transported her to the Hospital. The EMS was there for about 40 minutes and used an machine to preform the compressions. She was pronounced deceased at the hospital. No autopsy was done.",Yes,02/08/2021,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/23/2021,7.0,UNK,"Nisidipine 90 MG once day, Ramipril 20 MG once a day, Synthroid 137 MCG once a day, Aricept 10 MG once a day",,"Hypertension, Hypothyroidism, early dementia, Vertigo",,,"['Condition aggravated', 'Death', 'Dizziness', 'Fall', 'Feeling abnormal', 'Resuscitation', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 1040934,FL,66.0,M,"-Approximately 5 hours after injection, developed 12 hours of chills (no fever), diffuse aching, fatigue, and very low energy. -Approximately 3 days after vaccine noted difficulty completing usual daily exercise routine-stamina appeared low. -Approximately 3-5 days after vaccine noted difficulty completely taking in deep breath, with ""catch"" or discomfort in substernal area. -During early morning hours of day 7 after vaccine, was awakened with sharp, intense toothache pain right flank. With change of position was able to get comfortable after which pain resolved. This reoccurred the next two nights prompting ED visit. -First ED visit focused on right flank pain and CT Abdomen and pelvis was negative except for ""atelectasis"" right lung base -Due to more pleuritic symptoms, second ED visit occurred, and CT chest with contrast demonstrated bilateral PEs (approximately 5 on right and 2 on left) with evidence for RV strain -Hospitalized and started on anticoagulation (Lovenox SQ for one dose and then Eloquis). Echocariogram confirmed mild RV dilatation. Interventional Radiology did not feel removal/lysis of clots necessary. -Completed exhaustive evaluation with Hematology--no underlying clotting disorder identified to date -Have returned to 100% activity without significant symptoms at present",Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/31/2021,02/07/2021,7.0,PUB,Atacand 8 mg daily Pepcid 40 mg daily Simvistatin 10 mg daily,None,History of stage I renal cell cancer in October 2019--status post partial left nephrectomy. Recent imaging studies negative for active disease. Current CT chest/abdomen/pelvis negative for active disease.,,None,"['Anti factor Xa assay normal', 'Antinuclear antibody negative', 'Antiphospholipid antibodies', 'Antithrombin III', 'Asthenia', 'Atelectasis', 'Cardiolipin antibody', 'Chest discomfort', 'Chills', 'Coagulation factor V level', 'Computerised tomogram abdomen', 'Computerised tomogram thorax', 'Dyspnoea', 'Echocardiogram abnormal', 'Electrocardiogram ST-T segment abnormal', 'Factor II mutation', 'Fatigue', 'Flank pain', 'Loss of personal independence in daily activities', 'Pain', 'Protein C', 'Protein S', 'Prothrombin time normal', 'Pulmonary embolism', 'Red blood cell sedimentation rate normal', 'SARS-CoV-2 test negative', 'Toothache']",2,MODERNA,IM 1040945,MI,80.0,F,"Confusion, Admitted to Hospital on 2/12/21 Noted to have siezures",Not Reported,,Yes,Yes,,Not Reported,N,01/28/2021,02/10/2021,13.0,UNK,"AdvAIR Diskus 250 mcg-50 mcg inhalation powder, 1 puff(s), Inhalation, bid, Investigating: unknown last dose Combivent inhalation aerosol with adapter, 2 puff(s), Inhalation, bid, Investigating: unknown last dose Levemir FlexPen 100 u",Anemia Asthma DM (diabetes mellitus) HTN (hypertension) Obesity,Anemia Asthma DM (diabetes mellitus) HTN (hypertension) Obesity,,No known Allergies,"['Confusional state', 'Electroencephalogram', 'Magnetic resonance imaging brain', 'Seizure']",UNK,PFIZER\BIONTECH, 1040949,NC,79.0,F,"9:05 AM on 2/10/21 - Fever of 101.3F with lethargy; emesis x1 followed by Respiratory distress (O2 sat 90% room air, RR 40); HR 115 regular rhythm; decreased breath sounds with rales upper lobes and no breath sounds at base; tranferred via EMS to local hospital ER where received 2L fluids and admitted to care of hospitalist service with primary diagnosis of ""adverse effect of COVID-19 vaccination and possible pneumonia."" Presenting hypotension improved with fluid bolus and Zosyn IV was started empirically.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/09/2021,02/10/2021,1.0,OTH,"Cranberry Concentrate, Nexium 20 mg, Levothyroxine 88 mcg, Metoclopramide 5 mg, Senna Syrup, Calcium Citrate, Cholecalciferol, Centrum MVI with Minerals, Albuterol Inhalation 2.5 mg/ 3 ml, Flonase 50 mcg Nasal Spray, Eucerin Cream, Bag Balm",none,"Hypothyroidism, GERD, Recurrent UTI's, Dysphagia (enteral J-tube feedings), Reactive Airway Disease due to Aspiration Pneumonias, Constipation, Renal Insufficiency (Calc CrCl 32 ml/min)",,none,"['Blood urea nitrogen/creatinine ratio increased', 'Breath sounds abnormal', 'Chest X-ray abnormal', 'Computerised tomogram thorax', 'Computerised tomogram thorax normal', 'Hypotension', 'Lethargy', 'Neutrophil percentage increased', 'Pyrexia', 'Rales', 'Respiratory distress', 'Vomiting', 'White blood cell count increased']",2,MODERNA,IM 1040955,MA,90.0,F,"Patient presented with hematochezia and bright red blood per rectum. Platelets were severely down to 1k. This was about 2 weeks after receiving the moderna COVID-19 vaccine first dose. Patient also with extensive ecchymosis on upper extremities and petechial rash on legs. Concern for ITP related to the drug. Patient received IVIg, Platelet transfussion, and steroids. Platelets slowly increasing, patient received NPLATE. The patient remains hospitalized with platelets up trending from 1--- >4--- >6--- >5--- >9--- >11.",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,02/05/2021,02/13/2021,8.0,PVT,Aspirin 81mg Atorvastatin 20mg Caltrate 600+D 600mg calcium - 800 unit - 50mg tablet Levothyroxine 100mcg Zyrtec 10mg Oxbutynin 5mg Tolterodine 2mg,none,"Hyperlipidemia, overactive bladder, hypothyroidism, hemorrhoids",,grass pollen,"['Blood fibrinogen', 'Blood smear test normal', 'Ecchymosis', 'Fibrin D dimer normal', 'Haematochezia', 'Haemoglobin normal', 'Immunoglobulin therapy', 'Petechiae', 'Platelet count decreased', 'Platelet transfusion', 'Rash', 'Rectal haemorrhage', 'White blood cell count normal']",1,MODERNA,IM 1040968,SC,39.0,F,"The patient was admitted to the hospital on February 10, 2021 for evaluation of jaundice. This is a healthcare worker (direct patient care) and she received the first dose of Covid 19 vaccine in January 13 2021, then subsequently developed some abnormalities of the liver enzymes and thrombocytopenia. Because of this, her second vaccine was held. She also subsequently noticed scleral jaundice. She reports that it was 5 days since the COVID-19 vaccine on January 13 when she developed a rash which was present in the legs anterior abdomen and arms. Then 8 days after the vaccine, she developed a different rash on top of the original which was less petechial and more maculopapular. The rash is pruriginous, its been intermittently worsening and improving. She had no fever associated with the rash, although she reports that the day before admission February 9, she had some chills and sweats. She had some mild abdominal pain and cramps. No prior history of hepatitis. She also developed a petechial rash predominantly in the lower extremities. Results of ancillary studies showed that her AST is currently (02/12/21) 196 ALT of 61, her bilirubin total was 7.9 with a direct of 5.5, and on admission her AST was 183 ALT 40, with a total bilirubin of 14. Her platelet count on admission was 111, currently is 93. She has some mild microcytic anemia and no leukopenia and in the differential she has increased monocytosis. Her viral hepatitis serology panel shows hepatitis a IgM that is negative hepatitis B surface antigen and core antibody negative, hepatitis B surface antibody positive consistent with previous vaccination, and hepatitis C antibody negative. COVID-19 antigen was negative on admission 2/10/2021 she reports that she had a Covid PCR done in her office 5 days or so before admission that was also negative. She has been seen by our GI who evaluated her liver abnormalities. Imaging studies including a CT scan of 2/10/2021 showed chronic changes in the colon that could be consistent with inflammatory process such as ulcerative colitis, and a diffuse heterogeneous enhancement of the liver with nodularity that could be consistent with cirrhosis. She has a splenic varices and gastric varices which would make the diagnosis of cirrhosis certainly possible. An MRI of her abdomen on 2/11/2021 shows confirmation of the cirrhotic changes in the liver biliary dilatation or gallbladder abnormalities. There is evidence of portal hypertension. He also had a liver ultrasound that shows findings consistent with possible cirrhosis, including splenomegaly, hepatomegaly, and GB sludge. Alpha 1 antitrypsin, LKM antimitochondrial and anti-smooth muscle antibodies are negative. ANA and ANCA are pending. CMV and EBV PCR are pending. Given the unclear underlying etiology of her liver abnormalities, she had a liver biopsy. Result-Suggestive of NASH and confirms F4 cirrhosis. The patient was a started on Cipro and Flagyl empirically because of the findings on the colon suggestive of possible cholangitis. She has normal renal function. She has had no tick bites, no exposure to animals, no external factors consistent with atopic dermatitis or allergic type of rash. She reports that before admission, she had normal platelets about 1 or 2 years ago when she was tested, as well as normal liver function test. She reports that she has had some mild epistaxis as well as bleeding from her lips. She has some anorexia, she has had some looser stools but has been clear without obvious blood and she has had no hematuria. EGD on 15FEB2021- mild portal hypertensive gastropathy. Low risk esophageal varices. Labwork 15FEB2021- AST 173/ALT 64/Alk Phos 235/Plt 109/ Discharged on 02/15/2021 to home with plans for follow-up with GI and PCP. Prescribed Prednisone with taper off after 28 days. Follow-up appointment has not yet occurred as of the day this report is submitted(2/19/2021).",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,01/13/2021,01/18/2021,5.0,PVT,Claritin 10 mg Daily Melatonin 5 mg Nightly Multivitamin Daily Ritalin 20 mg 4 times Daily,None reported,"Anxiety, Asthma, Polycystic ovarian syndrome, Depression",,Codeine,"['Abdominal pain', 'Alanine aminotransferase increased', 'Antimitochondrial antibody normal', 'Antineutrophil cytoplasmic antibody', 'Antinuclear antibody', 'Aspartate aminotransferase increased', 'Autoantibody negative', 'Bilirubin conjugated increased', 'Biopsy liver abnormal', 'Blood alkaline phosphatase increased', 'Blood bilirubin increased', 'Blood immunoglobulin M', 'Chills', 'Cholelithiasis', 'Colitis ulcerative', 'Computerised tomogram abnormal', 'Cytomegalovirus test', 'Decreased appetite', 'Diarrhoea', 'Epistaxis', 'Epstein-Barr virus test', 'Gastric varices', 'Hepatic cirrhosis', 'Hepatic enzyme abnormal', 'Hepatitis A antibody', 'Hepatitis B core antibody negative', 'Hepatitis B surface antibody positive', 'Hepatitis B surface antigen negative', 'Hepatitis C antibody negative', 'Hepatomegaly', 'Hyperhidrosis', 'Jaundice', 'Lip haemorrhage', 'Magnetic resonance imaging abdominal abnormal', 'Microcytic anaemia', 'Monocyte count increased', 'Monocytosis', 'Non-alcoholic steatohepatitis', 'Occupational exposure to SARS-CoV-2', 'Ocular icterus', 'Petechiae', 'Platelet count decreased', 'Portal hypertension', 'Portal hypertensive gastropathy', 'Proctitis', 'Prurigo', 'Rash', 'Rash maculo-papular', 'SARS-CoV-2 test negative', 'Smooth muscle antibody negative', 'Splenic varices', 'Splenomegaly', 'Thrombocytopenia', 'Ultrasound scan abnormal']",1,PFIZER\BIONTECH,IM 1040985,TX,65.0,F,"Started feeling bad, throat started hurting, lost voice. Still am unable to talk very well and has been going on for 4 weeks.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/19/2021,01/20/2021,1.0,WRK,None,None,None,,None,"['Aphonia', 'Culture throat', 'Feeling abnormal', 'Full blood count', 'Metabolic function test', 'Oropharyngeal pain', 'Streptococcus test', 'Ultrasound scan']",2,PFIZER\BIONTECH,IM 1041005,LA,73.0,M,Pt. recieved 2nd dose COVID vaccine on 2 Feb and was admitted to Hospital on 3 Feb with Chest pain; DKA (diabetic ketoacidoses); Diabetic ketoacidosis without coma associated with type 1 diabetes mellitus; Hyperglycemia. He was discharged on 5 Feb. His home course is unknown,Not Reported,,Not Reported,Yes,16.0,Not Reported,U,02/02/2021,02/03/2021,1.0,PVT,,,type 1 diabetes mellitus; Stable angina,,NKA,"['Chest pain', 'Diabetic ketoacidosis', 'Hyperglycaemia']",2,PFIZER\BIONTECH,IM 1041032,CT,72.0,F,"Severe rash at site. Moderna # 025J20A, Continuing Pain thereafter. Second dose Moderna #028L20A January 20, 2020. Great and debilitating pain muscular and at joints. Rx Methylprednisone on February 9, Six day: six, five four, Three, Two and One tablets , 4mg. Relief to fourth day when symptoms reappeared. Patient is in extreme pain.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/23/2020,12/24/2020,1.0,PVT,"Topical Estrace (Estrogen) Cream, bi weekly, more than 5 years. Severe rash at site. Moderna # 025J20A, Continuing Pain thereafter. Second dose Moderna #028L20A January 20, 2020. Great and debilitating pain muscular and at joints. Rx Methyl",None,,,,"['Arthralgia', 'Blood test', 'Injection site rash', 'Myalgia', 'Pain']",2,MODERNA,IM 1041039,CT,80.0,F,Reddening and burning of top of ears. Blood pressure became erratic. Going from dangerously low to dangerously high. lowest reading 80/50 highest reading 200/100. Still erratic,Not Reported,,Yes,Not Reported,,Not Reported,N,02/04/2021,02/08/2021,4.0,OTH,Losartan 50 mg Synthroid .075 mcg Prozac 10 mg Spironolactone 50 mg Lorazapam .05 mg,No,Kidney block causing high blood pressure. Under control with medications and doctors care.,,Pencillin,"['Blood pressure fluctuation', 'Computerised tomogram head normal', 'Ear discomfort', 'Erythema', 'Renal function test normal']",2,MODERNA,SYR 1041064,IA,88.0,M,CLIENT EXPIRED 1 WEEK FOLLOWING THE VACCINE.,Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/11/2021,7.0,PUB,,,,,NONE,['Death'],,MODERNA,IM 1041068,FL,86.0,F,"Atrial Fibrillation ,blood pressure low",Not Reported,,Yes,Yes,2.0,Not Reported,Y,02/14/2021,02/15/2021,1.0,PVT,none,Diabetes,Diabetes,,none,"['Atrial fibrillation', 'Hypotension']",2,PFIZER\BIONTECH,SYR 1041081,WI,92.0,M,"Patient came to our ED on 2/6/2021 with worsening weakness and fatigue, which he claimed that had been experiencing since the date of vaccination on 1/26/2021. His rapid COVID test came back positive. He was admitted and treated in our COVID unit. His condition improved and he was discharged to home on room air on 2/10/2021.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/26/2021,01/01/2021,,PVT,Toprol XL; Lasix; Lipitor; Eliquis; Lotensin; Allopurinol; ASA; Albuterol inhaler; Coenzyme Q10,Unknown,Chronic heart failure; Emphysema; Stage 3b CKD; CAD,,None,"['Asthenia', 'COVID-19', 'Fatigue', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1041155,MN,70.0,F,ACUTE LEFT SIDED COSTOPHRENIC PAIN AND NAUSEA WITH RAPID DEVELOPMENT OF BILATERAL NUMBNESS WITH ATAXIA STARTING AT FEET RISING TO GROIN IMMEDIATELY. NUMBNESS AND PARAPLEGIA PERSISTED AND AROSE TO RIBS WITHIN 12 HOURS TWO ER VISITS. HOSPITALIZED AND MONITORED FOR FOUR DAYS DX: ACUTE GUILLAIN-BARRE SYNDROME per NEUROLOGY Received 4 infusions of IViG. 1 infusion per day X 4 days.,Not Reported,,Yes,Yes,4.0,Not Reported,N,02/11/2021,02/12/2021,1.0,OTH,ATORVASTSTIN 10 MG q DAY,NONE,NONE,,NONE,"['Ataxia', 'Blood electrolytes', 'CSF test', 'Full blood count', 'Guillain-Barre syndrome', 'Hypoaesthesia', 'Immunoglobulin therapy', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging spinal', 'Nausea', 'Pain', 'Paraplegia']",1,MODERNA,IM 1041160,,41.0,F,"I started with severe bloating and constipation. Then it progressed over a 12-15 hour period to vomiting and abdominal pain. I went to the emergency room of Hospital, and was diagnosed with appendicitis. I had an emergency appendectomy. I have never previously experienced constipation or symptoms related to appendicitis. After reading about a possible increase in Bell's palsy and appendicitis in the clinic trials, I wanted to err on the side of caution and submit this incident for data purposes and tracking.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/02/2021,02/05/2021,3.0,MIL,"Fish Oil, Vitamin D3 (2000 IU), melatonin 6 mg, zinc 12.5 mg, chlorthalidone 25 mg, Potassium CL 20 MEQ",None,Previously HBP but currently controlled PCOS Overweight Recurring Kidney Stones,,"Shellfish, penicillin, ciprofloxacin, torodal (possible), dogs, cats, dust mites, trees","['Abdominal distension', 'Abdominal pain', 'Appendicectomy', 'Appendicitis', 'Blood test', 'Constipation', 'Pathology test', 'Ultrasound scan', 'Vomiting']",1,MODERNA,SYR 1041185,IL,86.0,M,Death within 30 days,Yes,01/18/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/18/2021,14.0,OTH,Levadopa; colace; lorazepam and morphine,COVID + 12/10/2020 recovered. Placed on Hospice care 10/2020,Dementia; HTN; Parkinson's; Bladder Cancer,,No Known Allergies,['Death'],1,PFIZER\BIONTECH,IM 1041191,,99.0,M,"Decedent had unwitnessed fall out of wheelchair 1/25/21 around 9:43am, denied head strike, pain, discomfort. Around 10:02pm, 1/25/21, decedent noted to have slurred speech and fluctuating HR, transported to Hospital and made cmo.",Yes,01/27/2021,Not Reported,Yes,2.0,Not Reported,,01/24/2021,01/25/2021,1.0,UNK,,,,,,"['Death', 'Dysarthria', 'Fall', 'Heart rate abnormal', 'Wheelchair user']",2,PFIZER\BIONTECH,IM 1041200,FL,87.0,M,"Patient described feeling nervous, anxious the next morning (Wednesday) after the vaccine. He later fell in the bathroom after using the restroom, his legs gave out (his words) and consequently was on the ground for 23 hours before being transported to the hospital. That was Thursday afternoon. He was diagnosed with COVID-19 on Saturday night and died the following Friday morning.",Yes,02/05/2021,Yes,Yes,9.0,Yes,N,01/26/2021,01/27/2021,1.0,PHM,,,,,,"['Anxiety', 'COVID-19', 'Death', 'Fall', 'Muscular weakness', 'Nervousness', 'SARS-CoV-2 test positive', 'Syncope']",1,MODERNA,IM 1041211,MO,63.0,M,"Patient is meeting diagnostic criteria for multisystem inflammatory syndrome post-vaccination. He received his 1st Moderna COVID vaccination on 12/31/2020 (037K20A) and his second COVID vaccination on 2/5/21 (029L20A). He began developing high grade fevers on 1/22/21 and was admitted to our facility on 2/8/21 due to ""fever of unknown etiology"" associated with hepatitis and coagulopathy on laboratory studies. He underwent an extensive evaluation which failed to reveal any other infectious, rheumatologic, or hematologic explanation for his clinical syndrome. He was ultimately discharged to outpatient care with ongoing supportive care for his fevers. His liver associated enzymes were improving at discharge.",Not Reported,,Not Reported,Yes,9.0,Not Reported,U,12/31/2020,01/22/2021,22.0,PVT,"Aspirin, amlodipine, multivitamin, lisinopril, Crestor.",None,"Hypertension, hyperlipidemia.",,NKDA,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood alkaline phosphatase increased', 'C-reactive protein increased', 'Coagulopathy', 'Hepatitis', 'Interleukin level increased', 'International normalised ratio increased', 'Prothrombin time prolonged', 'Pyrexia', 'Red blood cell sedimentation rate increased', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 antibody test positive', 'Systemic inflammatory response syndrome']",1,MODERNA,IM 1041230,SC,75.0,M,Patient received first dose of covid vaccine on 1/22/2021. Patient had no immediate reaction. Patient presented to the Emergency Department on 1/26/2021 c/o shortness of breath and chest pain. ECG showed a ST elevation myocardial infarction. Patient was treated and transferred to a cath lab where he died. Patient had significant coronary artery disease.,Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/26/2021,4.0,PVT,unknown,,"Hyperlipidemia, GERD, Monoclonal B-cell Lymphocytosis, Asthma, DJD of spine, osteoarthritis, hypertension",,,"['Acute myocardial infarction', 'Chest pain', 'Coronary artery disease', 'Death', 'Dyspnoea', 'Electrocardiogram ST segment elevation']",1,PFIZER\BIONTECH,IM 1041276,IL,87.0,M,"on 2/13 at 7:30am resident was observed congested, foaming at the mouth. transferred to the hospital, verbal report from hospital nurse stated the resident was admitted for hypercalcemia and dehydration. The resident expired on 2/14/21 at 9:30am. Died on 2/14/2021",Yes,,Not Reported,Yes,,Not Reported,N,02/12/2021,02/13/2021,1.0,SEN,"Namenda, Mirtazapine, Multi-vitamin, Loratidine, Effexor XR","Hypertension, dementia, arthritis","Hypertension. Recent decline in weight and appetite, 8 pound weight loss in 30 days.",,None,"['Death', 'Dehydration', 'Foaming at mouth', 'Hypercalcaemia', 'Respiratory tract congestion']",2,MODERNA,IM 1041279,PA,82.0,F,"1st day sore arm, 4th day-stroke like reaction, had to go to er",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/06/2021,02/10/2021,4.0,PHM,"levothyroxine 112mcg, lisinopril 20mg, baby aspirin 81 mg , atorvastatin 20mg,",,,,"morphine, sulphur","['Cardiac monitoring', 'Computerised tomogram', 'Magnetic resonance imaging', 'Neurological symptom', 'Pain in extremity', 'Whole body scan']",1,PFIZER\BIONTECH,IM 1041319,PA,86.0,F,2/8/21 pt noted to have BLE weakness. 2/10/21 pt admitted to Hospital and diagnosed with Guillain-Barre Syndrome. She received 5 days of IVIG treatment. 2/15/21 she was discharged from acute care and admitted to inpatient rehab where she is still admitted at this time.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/04/2021,02/08/2021,4.0,PVT,,,,,,"['Guillain-Barre syndrome', 'Immunoglobulin therapy', 'Lumbar puncture', 'Muscular weakness']",1,PFIZER\BIONTECH,IM 1041321,TN,55.0,F,"Flu-like symptoms, face going numb, right side weakness, double vision in right eye, migraine headache. Stroke like symptoms",Not Reported,,Not Reported,Yes,3.0,Yes,N,01/01/2021,01/01/2021,0.0,PUB,All medications that I currently take are prescribed by my physician.,No illnesses was taking place at the time of the vaccine.,Fibromyalgia,,"Pencillin, Keflex, IV Contrast with dye, bee stings","['Computerised tomogram', 'Diplopia', 'Hemiparesis', 'Hypoaesthesia', 'Influenza like illness', 'Magnetic resonance imaging', 'Migraine', 'Neurological symptom']",2,MODERNA, 1041333,MN,78.0,M,"He developed a fever on 1/8, become unable to swallow and bedbound. He was already end of life and Hospice care at the time of the vaccine.",Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/09/2021,4.0,SEN,"Lorazepam, Seroquel, Trileptal, Senna Plus, Acetaminophen, Aspirin, Buspar, Sinemet, Cyanocobalamin, Depakote, Aricept, Pepcid, Hydrochlorothiazide, Provera, Melatonin, Namenda, Dolophine, Milk of Magnesia, Morphine, Omeprazole, Sorbitol, F","End stage Dementia, End stage Parkinson's Disease, on Hospice care. Dependent in all cares, non-verbal.","End stage Dementia, End stage Parkinson's Disease, on Hospice care",,"Penicillin, Vicodin","['Bedridden', 'Dysphagia', 'Pyrexia']",1,MODERNA,IM 1041340,TX,52.0,M,"developed covid-like symptoms on 2/15, tested positive 2/17",Not Reported,,Not Reported,Yes,,Not Reported,N,02/13/2021,02/15/2021,2.0,PVT,unknown,unknown,unknown,,unknown,"['COVID-19', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1041352,MD,65.0,M,65 y.o. man was in excellent health until episode on 2/13. At 11:30 PM he drove from his home to do work in a cow barn. His wife joined him to help at about 12:15 AM and she found him to be disoriented and confused. He has no memory of what happened during the preceding 45 minutes. No indication of any fall or injury. He had no preceding medical problems. No medications. Had received his 1st Moderna COVID-19 vaccine at about 5:30 PM on 2/13. His wife took him to a local ER. No focal findings on neuro exam. His confusion gradually improved over the next 24-36 hours but he still can?t remember what happened at the beginning of the episode. Head CT revealed an incidental 6 mm colloid cyst in the 3rd ventricle. Transferred to Hospital for further evaluation and monitoring where seen by Neurosurg and Neurology. Had MRI and EEG. No arrhythmia on ECG or telemetry. Neurology felt the episode was due to transient global amnesia. Discharged on 2/16.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/13/2021,02/13/2021,0.0,PHM,aspirin 162 mg daily,None,None,,none,"['Cardiac telemetry normal', 'Colloid brain cyst', 'Computerised tomogram head abnormal', 'Confusional state', 'Disorientation', 'Electrocardiogram normal', 'Electroencephalogram normal', 'Full blood count normal', 'Laboratory test normal', 'Magnetic resonance imaging brain abnormal', 'Memory impairment', 'Transient global amnesia']",1,MODERNA,IM 1041355,OK,33.0,M,"Pt is currently hospitalized under my care with new onset thrombocytopenia, with platelets at 19,000. He has abdominal pain, nausea and vomiting, and diaphoresis with chills. No symptomatic bleeding at this time. Did admit to nose bleed a few days prior to admission.",Not Reported,,Yes,Yes,2.0,Not Reported,N,02/08/2021,02/18/2021,10.0,WRK,"Norvasc 10mg QD, Coreg 25mg BID, Zoloft 100mg QD, Elavil 100mg QHS",Carbon monoxide poisioning approximately 1 month prior.,"Anxiety, Bipolar, Hypertension, tobacco use",,Latex,"['Abdominal pain', 'Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood lactate dehydrogenase increased', 'Blood smear test', 'Chills', 'Epistaxis', 'HIV test', 'Haptoglobin', 'Hepatitis viral test', 'Hyperhidrosis', 'Nausea', 'Platelet count decreased', 'Thrombocytopenia', 'Vomiting']",UNK,PFIZER\BIONTECH,SYR 1041365,MO,61.0,F,"Patient got up from being in bed in the AM and noticed some numbness/tingling in bilateral extremities. There was concern for stroke so the patient came to the ER .The patient had received the second dose of the Pfizer vaccination 2 days prior. The patient received tPA and was treated in the ICU. After a short hospital course, the patient was discharged home.",Not Reported,,Yes,Yes,2.0,Not Reported,Y,02/02/2021,02/04/2021,2.0,PVT,"Aspirin, atorvastatin, cetirizine, cyanocobalamin, famotidine, levothyroxine, thiamine, trazadone, turmeric",None,"Hyperlipidemia, depression, hypothyroidism, GERD, arthritis",,Codeine (vomiting),"['Hypoaesthesia', 'Intensive care', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 1041385,IL,70.0,F,"Recieved vaccine on 1/15/21, seizure activity noted on 1/16/21 at 2pm. Transferred to hospital. Cause of seizure unclear. Admitted to Hospital returned to facility on 1/22/21. Recieved 2nd COVID-19 dose with no side effects noted.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/15/2021,01/16/2021,1.0,SEN,"Baclofen, lisinopril, furosemide, coreg, donepezil, Calcium",,Multiple Sclerosis,,"penicillin, ampicillin",['Seizure'],1,MODERNA,IM 1041399,CA,65.0,M,Optic Neuritis (Papillitis) OD Loss of central vision - 20/100,Not Reported,,Not Reported,Not Reported,,Yes,N,02/05/2021,02/07/2021,2.0,MIL,Abilify Ultram Adderall Pyridium Cardura Xalatan Zocor Testosterone Prilosec Finasteride Wellbutrin Carbamazepine Folic acid Gabapentin Metaxalone,see below,"PMH gastric bypass surgery in 2013 that resulted in 100 pound weight loss Septoplasty, nasal Possible CVA (couldn't remember the movie that he just saw at a theater) in 2014 extensively worked up at a facility as an inpatient with complete resolution and a totally normal workup per patient Bipolar disease Degenerative joint disease in the lower back and right knee BPH GERD Lipids Glaucoma",,No,"['Angiotensin converting enzyme', 'Anti-aquaporin-4 antibody', 'Antineutrophil cytoplasmic antibody', 'Bartonella test', 'Blood folate', 'Blood heavy metal test', 'Blood thyroid stimulating hormone', 'Central vision loss', 'Chest X-ray', 'Magnetic resonance imaging', 'Optic neuritis', 'Thyroxine', 'Toxoplasmosis', 'Treponema test', 'Vitamin B12']",1,PFIZER\BIONTECH,IM 1041456,TX,63.0,M,"Shortness of breath - Initial ED Comments: Patient is a 63 y.o. male patient presenting to the ED via EMS with c/o shortness of breathin which began this morning. EMS reports that the pt had a bilateral lung transplant 1 year ago and has been on cyclosporine and cellcept. EMS also reports that the pt recently received his COVID vaccine. Pt denies fever, chills, chest pain, abdominal pain, back pain, nausea, vomiting, or lower extremity edema. EMS reports that the pt does not normally require supplemental O2 but states that his O2 sat was 75% on 3 L NC home O2. EMS reports that they gave 2 albuterol, 1 Atrovent, and solumedrol. EMS also reports that they placed the pt on 10-15 L NRB and states that his O2 sat was stable at 100%. Pt denies any aggravating factors for his symptoms",Not Reported,,Yes,Yes,21.0,Not Reported,N,02/02/2021,02/06/2021,4.0,PVT,"acetaminophen 1,000 mg Oral Every 6 hours PRN alendronate sodium 70 mg Oral Every 7 days, with water on empty stomach,nothing by mouth and don't lie down for 30 minutes; Wednesdays azithromycin 500 MG Oral Daily, Please take one tablet",Lung Transplant 3-26-20 Positive for Mycobacterium avium 7/29/20 and positive again on 9/30/20,"Prior to Lung Transplant - had Bronchiectasis and COPD Also had hyperlipidemia, hypertension, Osteoporosis, coronary artery disease, benign prostatic hyperplasia",,Penicillin NSAIDS Aspirin,"['Aortic arteriosclerosis', 'Arteriosclerosis coronary artery', 'Atelectasis', 'Cardiomegaly', 'Chest X-ray abnormal', 'Cholelithiasis', 'Computerised tomogram thorax abnormal', 'Dyspnoea', 'Gastrointestinal tube insertion', 'Lung consolidation', 'Lung opacity', 'Lymphadenopathy', 'Pleural effusion', 'Pneumonia']",1,PFIZER\BIONTECH,IM 1041485,NY,54.0,F,Patient suffered from a stroke 4 days after the second vaccination,Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/11/2021,02/15/2021,35.0,UNK,Patient has high cholesterol,,recovering from alcohol addiction,,none,"['Cerebrovascular accident', 'Intensive care']",UNK,MODERNA, 1041487,MN,65.0,F,"Patient developed shortness of breath and irregular heart beat 8 days after receiving immunization. Presented to the Clinic and was sent to the Emergency Department for evaluation. Admitted for PE, NSTEMI, and afib with RVR 2/11/21. Discharged to home 2/12/21.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/01/2021,02/09/2021,8.0,WRK,,,,,,"['Acute myocardial infarction', 'Atrial fibrillation', 'Dyspnoea', 'Heart rate irregular', 'Pulmonary embolism']",2,PFIZER\BIONTECH,IM 1041500,NV,85.0,F,"Patient presented to the ED 2/15/2021 for shortness of breath and lightheadedness with near syncopal event. The pt reported 2 episodes of SOB and lightheadedness, with the second one as the more severe. On her second episode, she felt severe shortness of breath, tried to walk quickly to her bed with her walker, and fell into her bed. CT angio demonstrated acute saddle PE, mild right heart strain, RUL pulmonary infarct, and mild multifocal pneumonia with suspicion of COVID; IR was consulted and suggested thrombectomy due to the severity of the embolism. In the ED, she was started on heparin drip and put on low-flow NC oxygen without distress. Upon arrival to the emergency department her vital signs were significant for T 36.4, SBP 120/81, HR 95 bpm, NSR, RR 18, FiO2 94% on room air. Her oxygen increased to 98% on 2 L nasal cannula. Her laboratory values revealed WBCs 15.1, Hb 14.4, HCT 43.4, PLT 321, neutrophils 68.8%, D-dimer 4642, NA 134, K3.4, anion gap 9, BUN 17, creatinine 1.00, glucose 163, troponin elevated 0.12, 0.25, and 0.41, urinalysis is unremarkable, COVID-19 swab is positive. A thrombectomy was performed 2/16/2021. She tested COVID positive on 2/16/2021 and her SpO2 remains in the high 90s with dips to mid 80s while talking, but she does not currently experience any SOB.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/30/2021,02/14/2021,15.0,PVT,"calcium-vitamin D extended release, 2 Tab, PO, Daily Combigan ophth soln, 1 Drop, Eye, Left, Daily multivitamin, adult tab, PO, Daily Pred Forte 1% ophthalmic suspension, 1 Drop, Eye, Both, Daily Restasis 0.05% ophthalmic emulsion, 1 Dr",None,Cataracts,,No known allergies,"['Angiogram', 'Angiogram abnormal', 'Anion gap', 'Blood creatinine normal', 'Blood glucose increased', 'Blood potassium decreased', 'Blood sodium decreased', 'Blood urea normal', 'COVID-19', 'Dizziness', 'Dyspnoea', 'Fall', 'Fibrin D dimer increased', 'Haematocrit normal', 'Haemoglobin normal', 'Neutrophil percentage', 'Platelet count normal', 'Pneumonia', 'Presyncope', 'Pulmonary embolism', 'Pulmonary infarction', 'SARS-CoV-2 test positive', 'Thrombectomy', 'Troponin increased', 'Urine analysis normal', 'Walking aid user', 'White blood cell count increased']",1,MODERNA,IM 1041509,KY,61.0,F,"1st vaccine 2/13/2021; 20 mins post vaccination developed flushing and since developed HA, and CP onset 2/19/21. seen in ED 2/19/21 and admitted to hospital for additional workup; Dx on admission: Chest pain, unspecified type ;Acute nonintractable headache, unspecified headache type; Hepatic steatosis.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/13/2021,02/13/2021,0.0,PVT,,,DM type 1; Hypothyroidism; HLD; HTN; GERD; COPD; Obesity,,Morohine; PCN; Amoxicillin; Meperidine; Latex,"['Chest pain', 'Flushing', 'Headache', 'Hepatic steatosis']",1,MODERNA,IM 1041526,MO,55.0,F,"decreased LOC, increased lethargy",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/16/2021,02/17/2021,1.0,SEN,"voltaren, iron, Ativan, Lipitor, motrin, lantus, gabapentin, Pulmicort, buspar, Bisacodyl supp, ASA, Tylenol, Keppra, Mylanta, Norco, requip, Potassium, nitroglycerin, mididrine, metformin, mucinez, Pepcid, escitalopram",,"CHF, COPD, sleep apnea, epilepsy, hx of malignant neoplasm of bronchus and lung, major depressive disorder, hypotension, DM II, pain, hyperlipidemia, anxiety, GERD",,"codeine, Naprosyn, penicillins, fish, bee stings","['Depressed level of consciousness', 'Lethargy']",2,MODERNA,IM 1041536,IL,79.0,F,"fever, kidney infection",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/29/2021,02/19/2021,21.0,PVT,"phenytoin(100mg), amlodipine(5mg), irbesarten(300mg), phenobarbital(32.4mg), vit D( 4000)daily, folic acid(1mg)","kidney infection=WBC 20,000",left hemiplegic since age 32-aneurysm,,----,"['Computerised tomogram', 'Condition aggravated', 'Kidney infection', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1041542,KY,37.0,F,Patient received 2nd dose on 1/29/21. Was treated for symptoms of Guillian Barre syndrome requiring inpatient rehabilitation.,Not Reported,,Not Reported,Yes,,Not Reported,U,01/29/2021,02/06/2021,8.0,PVT,,,,,,['Guillain-Barre syndrome'],2,MODERNA,IM 1041562,,46.0,F,"My first Moderna vaccination was on 12/23/20 and 8 days later, on 12/31/20 I suddenly developed significant Raynaud's phenomenon (up to 10 episodes a day) followed by severe persistent finger pain. Subsequently had positive anti-Sm/RNP at high titer as well as positive anti-SSB antibodies and have been diagnosed with Undifferentiated Connective Tissue Disorder. Prior to 12/31/20, I had never had an episode of Raynaud's or any autoimmune disease.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/23/2020,12/31/2020,8.0,UNK,Multivitamin,None,None,,Sulfa,"['Antinuclear antibody positive', 'Pain in extremity', ""Raynaud's phenomenon"", 'Undifferentiated connective tissue disease']",1,MODERNA,IM 1041563,ID,85.0,F,"She had her vaccine, and 11 days later noticed her stool was very black like tar, and on the side had bright red blood. She went to the ER and she was admitted. They did an endoscopic exam but did not find anything. She then was discharged after a couple of days. She had an APT with her PCP on 2/9/21 and she had ordered blood work, and nothing changed. She ordered a repeat blood work on 2/13/21 and said that her count was 6.9, and was told to come in for some blood, and admitted again for a couple of more days. She had one unit of blood. She was discharged on 2/15/21. She saw a gastroenterology NP and she drew blood and her count was 8.4, and advised to start taking some iron. She does not show any further signs of bleeding, but does feel very weak, feels cold and the usual signs of anemia. She did have light headedness throughout this entire time as well.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/23/2021,02/03/2021,11.0,PVT,"Amlodipine, Pantoprazole, Levothyroxine, Pravastatin, Advair inhaler, calcium, zinc, Fibercon, oxygen 24/7, multivitamin, Benadryl daily.",None.,"Asthma/COPD, hypothyroidism.",,Penicillin.,"['Activated partial thromboplastin time', 'Anaemia', 'Asthenia', 'Blood test', 'Blood test abnormal', 'Dizziness', 'Endoscopic swallowing evaluation', 'Endoscopy', 'Faeces discoloured', 'Feeling cold', 'Haematochezia', 'Transfusion']",1,MODERNA,IM 1041595,IL,76.0,M,Received 2nd dose of Moderna on 1/26/21 and was admitted to the hospital (IVCH) for septic right knee on 2/17/2021,Not Reported,,Not Reported,Yes,,Not Reported,,01/26/2021,02/17/2021,22.0,SEN,,,,,,['Sepsis'],2,MODERNA,IM 1041621,PA,36.0,M,"Vague onset of malaise, fever, exertional dyspnea, chest pain that progressed approximately 1-2 weeks after the 2nd dose of the Pfizer vaccine. Led to development of pericardial effusion with cardiac tamponade physiology, atrial flutter, and subsegmental pulmonary embolism. Workup of other causes of pericardial effusion (e.g., infection, malignancy, autoimmune), and hypercoagulability were otherwise negative. 2nd dose of vaccine was on 1/4/2021 and pericardial effusion was diagnosed and evacuated on 2/14/2021. Patient hospitalized from 2/14/2021-2/17/2021. Patient is also healthcare provider.",Not Reported,,Yes,Yes,4.0,Not Reported,Y,01/04/2021,01/11/2021,7.0,PVT,Multivitamin,None,None,,None,"['Anti-cyclic citrullinated peptide antibody', 'Antinuclear antibody', 'Atrial flutter', 'Beta-2 glycoprotein antibody', 'Blood calcium', 'Blood culture', 'Blood thyroid stimulating hormone', 'C-reactive protein normal', 'Cardiac tamponade', 'Chest X-ray', 'Chest pain', 'Complement factor C3', 'Computerised tomogram abdomen', 'Computerised tomogram thorax', 'Coxsackie virus test', 'Dyspnoea exertional', 'Echocardiogram', 'Electrocardiogram', 'Epstein-Barr virus test', 'Fibrin D dimer increased', 'HIV test', 'Hypercoagulation', 'Influenza virus test', 'Lipoprotein (a)', 'Liver function test normal', 'Malaise', 'Neutrophil count', 'Parvovirus B19 test', 'Pericardial effusion', 'Protein S', 'Prothrombin level', 'Pulmonary embolism', 'Pyrexia', 'Red blood cell count increased', 'Red blood cell sedimentation rate increased', 'Rheumatoid factor', 'SARS-CoV-2 test negative', 'Troponin', 'Ultrasound Doppler']",2,PFIZER\BIONTECH,IM 1041655,AL,66.0,F,"My mother came home after receiving the Moderna vaccine shot and did not feel well. She had confusion, pain in her left arm near the injection site. She attempted to relax for a while and then became very nauseous, faint, and vomited. She claimed she tried to lay down in her bed and then attempted to get up to vomit and could not physically move. On Tuesday, I found her at 2:30 PM unconscious in her bed. Vomit/blood all over the floor by the bed side, her face was very warm, her breathing was very short. I could not get her to respond to me through feel or communication so I called 911. She was taken to the ER by ambulance at this time. She was taken the hospital where she was placed on IVs (I think one for antibiotic and the other was a steroid). Hospital performed blood work, CT scan, chest x-ray, and lumbar tap. They did not find any issues with my mother other than she had an ""elevated white blood counter"". Lumbar tap did not yield any signs of infection or foreign bacteria. She was discharged on Wednesday (02/10/2021) evening and went home to rest. She has been very fatigue since her return home and reported to me today (02/19/2021) that she had symptoms of being faint, cold sweats, and overall weakness. I checked her blood pressure and temperature and did not see a concern.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/08/2021,02/08/2021,0.0,OTH,"Prednisone (5mg), Lorazepam (1.5mg) May have taken aspirin and a calcium supplement (500mg), but unsure.",Turbinate nose procedure ~2 weeks prior to vaccination,Adrenal insufficiency,,Sulfuric antibiotics,"['Asthenia', 'Blood test', 'Chest X-ray normal', 'Cold sweat', 'Computerised tomogram normal', 'Confusional state', 'Dyspnoea', 'Fatigue', 'Haematemesis', 'Injection site pain', 'Loss of consciousness', 'Lumbar puncture normal', 'Malaise', 'Mobility decreased', 'Nausea', 'Skin warm', 'Syncope', 'Vomiting', 'White blood cell count increased']",1,MODERNA,SYR 1041656,OH,103.0,F,she died 2/12/2021 at close to 2pm,Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/12/2021,6.0,SEN,Water pills other medication unknown,no,congestive heart failure,,unknown,['Death'],2,PFIZER\BIONTECH,SYR 1041694,MI,74.0,M,"bilateral facial paralysis, Treatment: Immune Globulin - 5 infusions, steroid, anti-viral; recovering; 6 days",Not Reported,,Not Reported,Yes,6.0,Not Reported,U,02/08/2021,02/09/2021,1.0,PVT,none,none,hemachromatosis,,none,"['Computerised tomogram', 'Facial paralysis', 'Lumbar puncture', 'Magnetic resonance imaging']",2,PFIZER\BIONTECH,IM 1041700,,83.0,M,"Patient's wife reported via telephone conversation with current nursing staff that patient had presented outpatient this morning around roughly 10:30AM, where he received his Covid-19 vaccination. He then went grocery shopping with his wife, and presented to home, where he began having notable difficulty swallowing and increased confusion, family had then sat him down in living room chair, where his daughter noted acute onset of tongue, upper/lower lip swelling, and right eye drooping. Patient's wife reports that he typically manages all of his home medications by himself, and manages his own ADL's without assistance at home. She reports that he did miss his noon dose of Sinemet, otherwise he has not missed any doses of current prescribed medications, and denies any recent start/change to current medication regimen, or OTC medications. Patient had difficulty swallowing scrambled eggs",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/17/2021,02/17/2021,0.0,UNK,,12/21/2020 PCP visit notes speech difficulty and weakness with voice changes and hoarse voice/talks in a whisper,"Hypertension, hyperlipidemia, gastroesophageal reflux disease, Parkinson's Disease, gait difficulty, coronary artery disease, history of stroke",,"Tetanus Toxoids - angioedema Macrodantin - ""affected his lungs""","['Angiogram cerebral abnormal', 'Arteriogram carotid abnormal', 'Carotid artery stenosis', 'Computerised tomogram head abnormal', 'Confusional state', 'Dysphagia', 'Extraocular muscle paresis', 'Lacunar infarction', 'Lip swelling', 'Magnetic resonance imaging brain abnormal', 'Swollen tongue']",2,PFIZER\BIONTECH,IM 1041701,FL,63.0,F,"15 minutes after receiving vaccination, pt reported it feels like ""my throat is closing up"", left sioded neck, arm, and chest pressure, and nausea. Pt does report she has had chest pressure intermittently for past 2 weeks but throat closing feeling began after vaccination. Pt received aspirin 324 mg po x1, diphenhydramine 25 mg IV x1, famotidine 20 mg IV x1, Solu-Medrol 125 mg IV x1, morphine 2 mg IV x1, and nitroglycerin 0.4 mg SL x1. Following treatment, pt reports she is free of chest pain and throat symptoms have improved.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/19/2021,02/19/2021,0.0,PVT,"cholecalciferol, metoprolol, Humalog, Trulicity, hydroxyzine, citalopram, isosorbide mononitrate. atorvastatin, Myrbetriq, furosemide, Flexeril, trazodone, gabapentin, levothyroxine",Pt has been having intermittent chest pain for weeks.,"Unstable angina, HTN, diabetes, anxiety, depression, bipolar, PTSD, chronic low back pain, fibromyalgia, OA, mitral valve prolapse, TIA, hypothyroidism",,"diclofenac, penicillins, venlafaxine","['Chest X-ray normal', 'Chest discomfort', 'Electrocardiogram normal', 'Limb discomfort', 'Musculoskeletal discomfort', 'Nausea', 'SARS-CoV-2 test negative', 'Throat tightness', 'Troponin normal']",1,MODERNA,IM 1041718,LA,23.0,F,"20 hours after the first dose of the Pfizer vaccine I developed right flank pain that felt like a kidney stone. The pain was mild at first but got quite severe within an hour to the point where I was on the floor crying. My boyfriend talked me into going to the ER, and I felt very nauseated in the elevator and the car. At the Hospital?s ER I received pain medication (Toradol and an opiod I can?t remember the name of), and a CT scan to determine if I had a kidney stone. No stone was seen on CT. After discussing the events with Dr., we determined that the Pfizer vaccine was the most likely, yet still quite unlikely, cause of my symptoms. I was sent home with some pain (Norco) and nausea (Zofran) medications and was told to follow up if the lain didn?t resolve over the next few days. My pain slowly faded and was gone by the next morning. Later that day (Jan. 16, 2021) I noticed I felt like I had a sunburn starting just superior to my right iliac crest and descending anteriorly about 20 cm, but my skin had no visible abnormalities. A few days later on Jan. 21 I noticed the area was slightly red. I took a photo and sent it to my mother, who is a PCP, asking what I should do and she instructed me to try applying topical Hydrocortisone. I did so 2-3 times per day as needed and the redness resolved within a few days. The sunburn sensation faded slowly but lasted until about a week ago (Feb. 12). Yesterday (Feb. 17) I noticed that my skin in that area is slightly numb. I can feel pressure and temperature, but I am unable to tell the difference between a touch and a light scratch. Sensation outside the affected area is normal.",Not Reported,,Not Reported,Not Reported,,Yes,,01/14/2021,01/15/2021,1.0,PVT,"Insulin (Novorapid), birth control (Junel Fe, Tevau).",N/A.,Type 1 diabetes.,,Latex sensitivity (not an allergy).,"['Burning sensation', 'Computerised tomogram normal', 'Crying', 'Erythema', 'Flank pain', 'Hypoaesthesia', 'Nausea']",UNK,PFIZER\BIONTECH,IM 1041719,WV,92.0,F,Pt received moderna vaccine #2 at 1:30pm. No s/s of adverse reactions. Ate dinner at 4pm. She was in her room at 430pm and she slid out of her chair and was laying on her Right side. She reported she slid out of her chair because she needed to go urinate per staff. She denied pain. At 630p complained of right hip pain. mobile xray was ordered. At 825pm resident was sleeping x 30 mins in her bed when she was found to have no pulse or respirations. She ceased to breathe. Mobile xray did not make it on time.,Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,SEN,"Depakote, lasix, memantine, metoprolol, senna s, vit D3, miralax, xarelto, remeron","Resident slid out of recliner at 430pm on the date of vaccine and death. Denied pain and ROM was without issues. At 630pm she complained of right hip pain. Mobile xray was ordered. Resident passed in her bed after sleeping for 30 mins. Xray did not make it on time, therefore, unsure of fracture.","Dementia, PVD, Vit D deficiency, anxiety, HTN, Afib, postrial kyphosis, CHF, UTIs, Debility, sundowning, skin neoplasm left side of nose",,Fosomax,"['Arthralgia', 'Death', 'Fall', 'Pulse absent', 'Respiratory arrest']",2,UNKNOWN MANUFACTURER,IM 1041738,ID,44.0,M,"-Age 25 dx with DM1 -12/2020 HbA1c 10% on insulin pump -2/5 second dose of Moderna vaccine (in R arm), R hip pain, resolved -2/7 R hand red/swollen, R second and third toes red/swollen -2/9 ED, given prednisone 40mg po qday and diphenhydramine for ?vaccine-related immune reaction. Afebrile, HR 101, BP 144 systolic. -2/10 Rheumatology outpatient visit, afebrile, ?acute polyarthritis of R hand and R foot, prednisone increased to 60mg po qday -2/11 ED afebrile, xrays done, 2g ceftriaxone, colchicine, doxycycline. -2/12 back to the ED. R hand more swollen. R toes perhaps improved. Admitted. -2/12 MRI R hand - ""There are small effusions in the second third and fourth MCP joints. There is some subtle synovial enhancement about the MCP joints best visualized on sagittal imaging. May be a small erosion in the fifth metacarpal head. There is some additional synovial enhancement about the lateral wrist. There are some subtle enhancement peripheral to extensor tendons at the wrist consistent with tenosynovitis. No other abnormality is apparent."" Given 500mg IV methylpred and 80mg po qday prednisone. Initially improved in first 24hrs and then edema returned. Discharged. No antibiotics. No markers for infection. -2/18 outpatient Rheum. R hand still swollen. Tried 3rd MCP join aspiration without fluid. Rapid taper of oral steroids as not helping. Had steroid injection R extensor wrist and 3rd MCP joint. Acute inflammatory polyarthritis affecting right hand and right foot. ?due to or triggered by COVID vaccine. Patient without h/o similar events/symptoms.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/05/2020,02/07/2020,2.0,PVT,,None.,Diabetes mellitus type 1 diagnosed at age 25.,,"Cyclobenzaprine caused ""edema.""","['Arthralgia', 'Aspiration joint', 'Erythema', 'Joint effusion', 'Magnetic resonance imaging abnormal', 'Oedema', 'Peripheral swelling', 'Polyarthritis', 'Tenosynovitis', 'X-ray']",2,MODERNA,IM 1041740,MN,70.0,M,Patient died on 2-13-21,Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,02/13/2021,38.0,PVT,"Escitalopram, gabapentin, trazodone, atorvastatin, hydrocodone/acetaminophen, ondansetron, lidocaine 5% patch, aspirin 81mg, pantoprazole, finasteride, calcium citrate, cholecalciferol, potassium, furosemide.",,,,None,['Death'],2,PFIZER\BIONTECH,IM 1041754,TX,64.0,F,"Three weeks after vaccine patient experienced Headache, Fatigue, nausea, chest pressure, deep, cough. WAs hospitalized 2/3/-2/4 for elevated blood pressure on observation. took next week off to regulate blood pressure. Saw PCP on 2/10 and was released for work on 2/15. Dr., hospitalist at Medical Center, .",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/12/2021,02/02/2021,21.0,PVT,UNK,UNK,UNK,,UNK,"['Blood pressure increased', 'Chest discomfort', 'Cough', 'Fatigue', 'Headache', 'Impaired work ability', 'Nausea']",1,MODERNA,IM 1041757,IA,80.0,M,Patient developed fever and severe weakness about 24 hours after second COVID-19 vaccine. Spouse called ambulance and taken to the ED. Patient unable to get out of bed by self due to weakness. Patient admitted to observation unit due to fever and fatique for PT and strengthening.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/17/2021,02/18/2021,1.0,PVT,"Furosemide,Metoprolol,MVI,Potassim Chloride,Tylenol PM, Cetriz",,"Osteoarthritis/Degenerative Joint Disease, Diastolic dysfunction, Hypertension, Obesity, Type 2 Diabetes",,None,"['Asthenia', 'Fatigue', 'Laboratory test normal', 'Mobility decreased', 'Pyrexia', 'X-ray normal']",2,MODERNA,IM 1041784,WI,73.0,M,"On the 25th he was home alone, he called 911 and let them know he thought he was having a stroke. EMS arrived and transported him to Hospital. It was massive stroke, he was not able to comprehend anything, he was put into Hospice the following day and passed away on the 27th. There was no autopsy preformed.",Yes,01/27/2021,Not Reported,Yes,2.0,Not Reported,,01/23/2021,01/25/2021,2.0,MIL,"Multivitamin, Thiamine, Amlodipine, Cholecalciferol, Donepezil, Folic Acid, Atorvastatin",,"A stroke a year and half before, AVM, Arthritis",,,"['Cerebrovascular accident', 'Confusional state', 'Death', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,SYR 1041789,NY,77.0,F,"As per patient daughter - patient had some minor chills on the day of the vaccination - Friday 1/15/21; felt well next day -Saturday, than she was found slumped and lifeless on the couch on Sunday 1/17. Cause of death on death certificate was reportedly put as COPD, Lung Ca and ASHD.",Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/17/2021,2.0,PVT,"Advair, Albuterol, ASA, Alendronate",no,"Advanced COPD on Oxygen therapy, Stage 1, lung Ca, Adenocarcinoma",,unknown,"['Arteriosclerosis', 'Arteriosclerosis coronary artery', 'Chills', 'Chronic obstructive pulmonary disease', 'Death', 'Lung neoplasm malignant']",1,PFIZER\BIONTECH,IM 1041804,DC,30.0,M,"30 yo man with no significant past medical history presents to the ED for chest pressure and SOB that started this morning when he woke up. It was a constant 8/10 pressure squeezing at the sides of his sternum with the sensation of a plate pushing down on his sternum, that worsened by taking deep breaths. He had never experienced anything like it before. The pain was neither worsened with exertion nor relieved by rest. It did not change with position, and it did not radiate to his arm/neck. He denies any tenderness to palpation of his chest. Ibuprofen 400 mg did not provide any relief. At time of interview denies SOB and reports decrease in chest tightness to 2/10. CP was significantly relieved with a bolus of normal saline in the ED. Tylenol also effectively reduced his pain. Of note, the patient received the second Moderna COVID vaccine shot 3 days ago. For 2 days after receiving the second shot he experienced fevers, chills, nausea, and intermittent vomiting (10 bouts of non-bloody emesis).",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/15/2021,02/17/2021,2.0,MIL,MVI Vitamin D,None,None,,No known allergies,"['Arteriogram coronary normal', 'Blood creatine phosphokinase increased', 'Blood lactic acid', 'Brain natriuretic peptide increased', 'Chest X-ray normal', 'Chest discomfort', 'Chills', 'Computerised tomogram normal', 'Dyspnoea', 'Electrocardiogram abnormal', 'Electrocardiogram normal', 'Fibrin D dimer increased', 'International normalised ratio normal', 'Lipase normal', 'Lymphadenopathy', 'Magnetic resonance imaging abnormal', 'Myocarditis', 'Nausea', 'Platelet count decreased', 'Pyrexia', 'SARS-CoV-2 test negative', 'Troponin increased', 'Vomiting']",2,MODERNA,IM 1041832,WV,74.0,M,Patient was found unconscious without a pulse. Patient remained in asystole without pulse or respirations despite CPR.,Yes,02/18/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/18/2021,1.0,OTH,,,,,,"['Cardiac arrest', 'Loss of consciousness', 'Pulse absent', 'Respiratory arrest', 'Resuscitation']",2,MODERNA,SYR 1041839,WV,72.0,F,Death- ~ 7 hours after vaccine,Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/14/2021,0.0,PHM,"Protonix 40 mg PO QD Vit D3 50,000 Units PO weekly MVI 1 tab PO QD Calcium Carbonate 600 mg1 PO QD Lantus 28 Units SQ in morning, 24 Units at dinner Iron 65 mg PO QD Monurol 3 gm PO, 3 pkts weekly Colesevelam 3.75 gm oral 1 pkt BID Plavix 7",HTN HLD CAD Type 2 Dm GERD hypothyroidism,HTN HLD CAD Type 2 Dm GERD hypothyroidism,,Sulfur,['Death'],1,MODERNA,IM 1041931,TN,51.0,M,"Pneumonia, hypoxemia, Dyspnea, Tachycardia,SIRS, increased lactic acid level, dehydration,fever, HTN, hypomagnesemia",Not Reported,,Yes,Yes,4.0,Not Reported,N,01/05/2021,01/05/2021,0.0,SEN,"Vitamin c, D, aspirin,zinc",COVID 12/192020,High Blood pressure controls by meds. ADD,,Peanuts,"['Blood lactic acid increased', 'Dehydration', 'Dyspnoea', 'Fibrin D dimer increased', 'Hypertension', 'Hypomagnesaemia', 'Hypoxia', 'Magnetic resonance imaging', 'Pneumonia', 'Pyrexia', 'Systemic inflammatory response syndrome', 'Tachycardia']",1,MODERNA,SYR 1041983,NV,75.0,F,"Admitted with covid pneumonia, Acute hypoxic respiratory failure, currently in ICU ventilator dependent respiratory failure. Patient tested 1/26 with 1/29 positive results. never symptomatic. presented to receive covid vaccine and received it on 2/1, ( reportedly discussed with a physician to make sure getting vaccine was ok) Then hospitalized 2/11 with urosepsis and discharged 2/14. 2/15 presented to oncology office with o2 sats 78% on RA. transported to Hospital.",Not Reported,,Yes,Yes,3.0,Not Reported,,02/01/2021,02/16/2021,15.0,UNK,unknown,"During her admission to this facility on 2/16/21, it was noted that the patient was vaccinated 6 days after positive test.","non-Hodgkin Lymphoma, Diffuse large B-Cell lymphoma, hypertension, chronic UTI",,morphine,"['COVID-19 pneumonia', 'Intensive care', 'Mechanical ventilation', 'Oxygen saturation decreased', 'Respiratory failure', 'Urosepsis']",1,PFIZER\BIONTECH,IM 1041990,KY,83.0,F,PATIENT WAS ADMITTED TO ER FOR ALTERED MENTAL STATUS / UTI SEPSIS WITH SEPTIC SHOCK / COVID AND COVID PNA PATIENT WAS ADMITTED TO ICU AND DIED . POA WISH TO WITHDRAWL EXTRME MEASURES,Yes,01/15/2021,Not Reported,Yes,,Not Reported,,12/28/2020,01/15/2021,18.0,PVT,,Covid IN NOVEMBER,"CKD , CAD WITH STATUS POST CABG , HTN HYPOTHYROIDISM, DEMENTIA AND RECURRENT UTI",,nkda,"['Acidosis', 'Body temperature decreased', 'COVID-19 pneumonia', 'Chest X-ray abnormal', 'Death', 'Hypotension', 'Intensive care', 'International normalised ratio increased', 'Mental status changes', 'Metabolic function test abnormal', 'Sepsis', 'Septic shock', 'Urinary tract infection']",1,PFIZER\BIONTECH,IM 1042012,NY,51.0,F,Patient died suddenly 2/14/2021,Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/14/2021,13.0,PVT,"Cabergoline, Avalide, Valtrex, Zyrtec",None known,"Prolactinoma/Pituitary adenoma (2018), HTN, Meniscal tear (knee), h/o myomectomy, h/o C-section",,None known,['Sudden death'],1,PFIZER\BIONTECH,IM 1042014,NY,45.0,F,"Daughter rec'd vaccine on 2/17 and she lost her voice and was unable to speak, she's had an underlying issue. She stayed for 30-45 minutes and started coughing and then lost her voice, her throat started itching and she could not speak she was very hoarse, her skin turned real dark and she went to the hospital, they gave her an EPI pen, Prednisone 40mg for 4 days, Albuteral was given, Solumedrol and Peptin, and benedryl, Ivciartin, She continues to have a deep hoarseness.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/17/2021,02/17/2021,0.0,OTH,"Yes, Prednisone, Tacrolimus, Crdvasdelol, Procardo XL, Clindamycin, Sevlamar, Replagamiroe,",no,Dialysis for renal failure 2/2020,,"Sulfa, Biaxin, Shell fish, mushrooms, pumpkin, eggplant, milk intolerant","['Aphasia', 'Aphonia', 'Blood test normal', 'Chest X-ray normal', 'Cough', 'Dysphonia', 'Echocardiogram normal', 'Electrocardiogram normal', 'Endoscopy normal', 'Hypersensitivity', 'Skin discolouration', 'Throat irritation']",1,PFIZER\BIONTECH,IM 1042097,MN,86.0,M,pt did not feel ill or had mild symptoms after 2nd dose of vaccine. 4 days later patient developed fever of 101 and not controlled with acetaminophen. Temp increased to 103 and patient taken to ER and then diagnosed with pulmonary embolism. Patient still hospitalized. Not sure if related to vaccine.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/12/2021,02/16/2021,4.0,PHM,"BACTRIM DS, BIOFREEZE, DOCUSATE SOD, CYANOCOBALAMIN 1000 MCG/ML INJ, IPRATROPIUM/ALBUTEROL NEB SOL, TAMSULOSIN, ACETOMINOPHEN 500MG, AMIODARONE 200 MG, ELIQUIS 5 MG, DONEPAZOLE 5mg, fluticasone nasal spray, ibuprofen 800 mg, furosemide 20-",none other than long-standing conditions,"Alzheimer's late onset, pneumonia, unspecified dementia, weekness, legal blindness, paroxysmal atrial fibrillation, edema unspecified, chronic obstructive pulmonary disease, atherosclerotic heart disease, essential hypertention, GERD, chest pain unspecified, iron deficiency, presence of other cardiac implants and grafts, heart failure",,"mirtazapine, morphine, nitroglycerin","['Pulmonary embolism', 'Pyrexia']",2,MODERNA,IM 1042108,SD,72.0,F,"Hypotension, shortness of breath, pruritic skin rash, generalized weakness, decreased urine output and fatigue beginning the day after the vaccination with worsening symptoms over the next 5 days. The patient reported dizziness, lightheadedness, and two falls. The patient was hospitalized on 02/10 and was treated with calamine lotion, cetirizine, diphenhydramine, famotidine, hydroxyzine, loratadine, and methylprednisolone. On 2/12 the patient had worsening itching, shortness of breath, and oxygen saturations of 92% and was given supplemental oxygen, IV diphenhydramine, and IV methylprednisolone.",Not Reported,,Yes,Yes,4.0,Not Reported,,02/04/2021,02/05/2021,1.0,OTH,,,,"Pneumococcal 23-Redness, pain, and swelling documented in chart on 3/22/2019. No further information available",,"['Asthenia', 'Dizziness', 'Dyspnoea', 'Fall', 'Fatigue', 'Hypotension', 'Pruritus', 'Rash pruritic', 'Urine output decreased']",1,MODERNA,IM 1042145,NC,82.0,F,"Patient reported feeling weak, fatigue, fever (102), and loss of appetite. Patient subsequently went to the ER 2/6/2021 and tested positive for COVID-19 on 2/7/21 (collection date). See following discharge summary from ED: 82 y.o. female who initially presented to the ED with complaint of generalized weakness, fatigue, fever, and loss of appetite x at least 4 days since receiving Covid 19 vaccine. Her workup in the emergency room was significant for hypoxia with 02 saturation 88% on 2LPM (home nocturnal 02 requirement) with improvement to mid-90s on 4LPM. Blood sugar was 47, Cr 1.61. CXR showed extensive R lung and moderate left lung opacities. She was started on empiric ceftriaxone and azithromycin and admitted to the hospitalist service for further workup and mgmt. During her stay in the hospital, pt did test positive for Covid 19. She developed rapidly progressive respiratory failure, felt to be secondary to ARDS. There was also question of contributing pulmonary edema, however this was refractory to lasix and thus ARDS was felt to be the most significant factor. She had requested DNR/DNI status, thus as her 02 requirement escalated she was transitioned to 15LPM NRB and then to BiPAP support. Unfortunately, she continued to suffer greatly with the BiPAP in place, and therefore made the decision to transition herself to comfort measures only after visitation from her family. Her other medical issues were supported as appropriate during her stay, with dextrose infusion for hypoglycemia and AKI, also hyponatremia felt to be due to IVVF. Unfortunately, am unable to find any documentation regarding how pt was feeling when she received the vaccine compared to her baseline state of health. thus am unable to say whether the severity of her illness represents vaccine� enhanced disease or the much more common cytokine release syndrome leading to ARDS. Regardless, she developed ARDS as result of her Covid 19 illness. Time of death: 1408 on 2/9/21. Cause of death: ARDS due to Covid 19 pneumonia.",Yes,02/09/2021,Not Reported,Yes,3.0,Not Reported,N,01/29/2021,02/06/2021,8.0,PUB,None,None reported,"PE, Asthma, Obesity, Diabetes, COPD",,None,"['Acute kidney injury', 'Acute respiratory distress syndrome', 'Asthenia', 'Bilevel positive airway pressure', 'Blood creatinine increased', 'Blood glucose decreased', 'COVID-19', 'COVID-19 pneumonia', 'Chest X-ray abnormal', 'Cytokine release syndrome', 'Death', 'Decreased appetite', 'Fatigue', 'Hypoglycaemia', 'Hyponatraemia', 'Hypoxia', 'Infusion', 'Lung opacity', 'Pyrexia', 'Respiratory failure', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1042159,FL,65.0,M,"RECEIVED VACCINE ON 2/9. FELT QUEASY BUT NOT BAD ON TUES PM AND WED. THEN FINE WED 2/10 NITE. ON THURSDAY 2/11 RASH STARTED ON LEFT ARM NEAR INJECTION SITE. TOOK OTC BENADRYL . STARTED SPREADING TO WHOLE ARM AND UPPER CHEST AND HEAD AND NECK. SEVERE SHEDDING OF SKIN. PAINFUL AND ITCHING. ON SUNDAY 2/14 WENT TO EMERGENCY ROOM AND WAS ADMITTED OVERNIGHT OBSERVATION. RECEIVED IV LIBRIUM, DIPHENHYDRAMINE, FAMOTIDINE, OLORAZEPAM, METHYLPREDNISOLONE SOD SUC (PF).",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/09/2021,02/09/2021,0.0,PVT,IRBESARTAN 300mg; ATORVASTATIN 40mg,NONE,HIGH BLOOD PRESSURE,,NONE,"['Activated partial thromboplastin time', 'Differential white blood cell count', 'Full blood count', 'Injection site rash', 'International normalised ratio', 'Metabolic function test', 'Nausea', 'Nucleated red cells', 'Rash', 'Rash pruritic', 'SARS-CoV-2 test negative', 'Skin exfoliation']",2,MODERNA,IM 1042172,OR,78.0,M,"myalgia/arthralgia, significant weakness followed by reactivation of rapid ventricular rate w/ his chronic Atrial Fib leading to angina and hospitalization w/i 2 days of vaccine. symptoms have not yet recovered, resulting in SNF placement",Not Reported,,Yes,Yes,8.0,Not Reported,N,02/05/2021,02/06/2021,1.0,UNK,"Vit B12, Eliquis, finasteride, fludrocortison, levothyroxine, lasix, potassium, sinemet, venclexta",None,"CLL, parkinsons dz, lewy body dementia, BPH, Atrial Fib., GERD",,clonazepam,"['Angina pectoris', 'Arthralgia', 'Asthenia', 'Atrial fibrillation', 'Brain natriuretic peptide increased', 'Chest X-ray normal', 'Condition aggravated', 'Electrocardiogram abnormal', 'Full blood count normal', 'Metabolic function test', 'Myalgia', 'Troponin I increased', 'Viral test negative']",1,PFIZER\BIONTECH,IM 1042321,NY,,M,"COVID-19 pneumonia; A spontaneous report was received from a nurse concerning a male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced Covid-19 pneumonia. The patient's medical history was not provided. Concomitant medications were not reported. On 20 Jan 2021, six days prior to the onset of events, the patient received their first two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient experienced symptoms of Covid-19 pneumonia. The reporter stated, the was patient tested positive for Covid-19 on 04 Feb 2021 and currently recovering from pneumonia. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event, Covid-19 pneumonia, was considered resolving.; Reporter's Comments: This case concerns a male subject of unknown age who experienced a serious unexpected event of COVID-19 pneumonia. Event onset on 26Jan21, 6 days after first dose of mRNA-1273 on 20Jan21. SARS-CoV-2 test positive on 04Feb21. Treatment not reported. Event resolving. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,02/04/2021,15.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['COVID-19', 'COVID-19 pneumonia']",1,MODERNA,OT 1042323,TX,71.0,F,"Stevens-Johnson Syndrome; A spontaneous report was received from a health care provider regarding a 71-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Stevens Johnson Syndrome, which results in blisters and rashes all over the body. The patient's medical history not included. No Concomitant medication was provided. On 02 Feb 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 025L20A) for prophylaxis of COVID-19 infection. On 03 Feb 2021, the day after the mRNA-1273 vaccine was given, the patient experienced Stevens Johnson Syndrome, causing rashes and blisters all over her body. Treatment information was not reported. Action taken with mRNA-1273 was not reported. The outcome of the events, Stevens Johnson Syndrome, causing rashes and blisters all over the patient's body, was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/03/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Stevens-Johnson syndrome'],1,MODERNA,OT 1042324,NE,,M,"sharp pain in feet (neuropathy); swelling at site of injection; felt yucky and not feeling good at all; bad diarrhea; A spontaneous report was received from a consumer concerning a male patient, who received Moderna's COVID-19 Vaccine(mRNA-1273) and experienced sharp pain in feet, vaccination site swelling, bad diarrhea and not just feeling good. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03 Feb 2020, the patient received their first of two planned doses of mRNA-1273 (batch number-010M20A) for prophylaxis of COVID-19. On 04 Feb 2020, at 4:00 AM, the patient experienced sharp pain in feet, vaccination site swelling, bad diarrhea and not just feeling good. No treatment medication was reported. The outcome of events sharp pain in feet, vaccination site swelling, bad diarrhea and not just feeling good were reported Recovering/Resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Diarrhoea', 'Neuropathy peripheral', 'Vaccination complication', 'Vaccination site swelling']",1,MODERNA,OT 1042326,LA,70.0,F,"went into afib that required hospitalization X24 hours after receiving immunization.; This is a spontaneous report from a contactable nurse. A 70-year-old female patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265; expiry date: unknown) intramuscular in the right arm, on 29Jan2021 at 09:30, at a single dose, for immunization/COVID-19 immunisation. Medical history included atrial fibrillation (afib). It was unknown if the patient has allergies. Concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient stated that she has a history of afib that has been well controlled for over 2 years. Patient has had 0 episodes during the past 2 years, but on 30Jan2021 at 14:00, she went into afib that required hospitalization X24 hours after receiving immunization. Patient also stated that afib is usually able to be converted with cardiazem but it was not effective this time. Outcome of the event was recovered. It was unknown if the patient was tested for COVID after vaccination.; Sender's Comments: A causal relationship between the event ""went into afib that required hospitalization X24 hours after receiving immunization"" and suspect product bnt162b2 is possible based on the information provided, drug profile and a temporal association in this 70-year-old female patient with history of Atrial fibrillation. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/29/2021,01/31/2021,2.0,PVT,,,Medical History/Concurrent Conditions: AFib (Other medical history: afib),,,['Atrial fibrillation'],1,PFIZER\BIONTECH,OT 1042327,MI,70.0,F,"Feeling very hot; lips numb and tingly; lips numb and tingly; headache; dizzy; heart beating hard in chest; anxiety; nausea with dry heaves; nausea with dry heaves; elevated blood pressure; This is a spontaneous report from a contactable nurse (self-reported). A 70-year-old female patient (who was not pregnant at the time of vaccine) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; el3249) via an unspecified route of administration, at right arm on 14Jan2021 14:00, at hospital for COVID-19 Immunization. Medical history included HTN (hypertension), GERD (Gastrooesophageal reflux disease), oral cancer 2020 with surgery only, arthritis, hypothryroid and allergies to nickel. Concomitant medications included, irbesartan (AVAPRO), levothyroxine, liothyronine (NP THYROID), lansoprazole (PREVACID), ibuprofen (MOTRIN) and paracetamol (TYLENOL). The patient previously took metoclopramide (REGLAN) and prochlorperazine edisylate (COMPAZINE); patient had allergies to both drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of medications the patient received within 2 weeks of vaccination, included: avapro, np thyroid, prevacid, motrin, Tylenol. On 14Jan2021 at 14:15 (after 15 minutes of dose), the patient experienced feeling very hot, lips numb and tingly, headache, dizzy, heart beating hard in chest, anxiety, waited another 15 minutes, taken to ER (Emergency Room) on site; elevated blood pressure, nausea with dry heaves. Patient was taken into Emergency room/department for urgent care and received treatment IV solumedrol, ativan and zofran, oral Benadryl. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unknown date in 2021; Sender's Comments: There is a reasonable possibility that the events headache and nausea were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported serious events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,PVT,AVAPRO; NP THYROID; PREVACID; MOTRIN [IBUPROFEN]; TYLENOL,,Medical History/Concurrent Conditions: Arthritis; GERD; Hypertension (htn); Hypothyroidism (hypothryroid); Nickel sensitivity (nickel allergy); Oral cancer stage unspecified (oral cancer 2020 with surgery only); Surgery,,,"['Anxiety', 'Blood pressure increased', 'Dizziness', 'Feeling hot', 'Headache', 'Hypoaesthesia oral', 'Nausea', 'Palpitations', 'Paraesthesia oral', 'Retching']",1,PFIZER\BIONTECH, 1042328,OK,54.0,F,"Patient had low platelets and had to have a platelet transfusion; This is a spontaneous report received from a contactable nurse. A 54-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3248, Pfizer product), via an unspecified route of administration on right arm on 07Jan2021 at single dose for COVID-19 immunization in hospital. The patient's medical history included ongoing possibly has rheumatoid arthritis. No known allergies to medications, food, or other products. Concomitant medication included meloxicam (MOBIC) and multivitamin. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Pfizer product), intramuscularly on left arm on 17Dec2020 (54-year-old, Lot number: EH9899) at single dose for COVID-19 immunization. The patient did not diagnose with COVID-19 prior to vaccination. The patient did not test for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021 11:00, the patient experienced low platelets and had to have a platelet transfusion. The patient visited doctor or other healthcare professional office/clinic and visited emergency room/department or urgent care due to the event. The event was considered as non-serious by the nurse. The outcome of the event was not recovered.; Sender's Comments: Based on the temporal relationship, the association between the event low platelets requiring platelet transfusion with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,02/04/2021,28.0,PVT,MOBIC; MULTIVITAMIN [VITAMINS NOS],Rheumatoid arthritis,,,,"['Platelet count', 'Platelet count decreased']",2,PFIZER\BIONTECH, 1042329,FL,,F,"still her sore throat was going bad, didn't get better/sore throat had been going on for two weeks; her headaches were the same/She had a headache that didn't go away; her eyes sight, her vision sometimes was not clear/Her vision had also been affected. Sometimes she cannot see clearly; her lips looked like when had a high fever, which she hadn't and it's blue, the skin was going off/Her lips looked like she had a fever. Her lips were blue. Her lips were losing skin; her lips looked like when had a high fever, which she hadn't and it's blue, the skin was going off/Her lips looked like she had a fever. Her lips were blue. Her lips were losing skin; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient stated that still her sore throat was going bad, didn't get better and her headaches were the same, her eyes sight, her vision sometimes was not clear and her lips looked like when had a high fever, which she hadn't and it's blue, the skin was going off and she didn't know. Her biggest concern was her headache and her sore throat. She called her Doctor and he said there was nothing that he can do to call for advice. She had been taking every 4 hours Tylenol and taking antiseptic for her sore throat which had helped her in numb that site and help her for like 1 hour-1 hour and a half but then it came back. She had side effects that were still active. The worst side effect was a sore throat. Her sore throat had been going on for two weeks at the time of the report. Sometimes it seemed like it was going to get better, and then it came back. Her vision had also been affected. Sometimes she cannot see clearly. She had a headache that didn't go away. Her lips looked like she had a fever. Her lips were blue. Her lips were losing skin. She had taken her temperature, and she didn't have a fever. The outcome of the events was not recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,,,UNK,,,,,,"['Body temperature', 'Cyanosis', 'Headache', 'Lip disorder', 'Oropharyngeal pain', 'Visual impairment']",1,PFIZER\BIONTECH, 1042330,AZ,85.0,M,"brain has slowed down; starting to lose his memory/memory loss; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot nubmer: EL1283), via an unspecified route of administration on 29Jan2021 at a single dose on the right arm for COVID-19 immunization. Medical history included heart valve replacement on an unknown date. The patient stated that he was taking concomitant medications (unspecified) but nothing out of the ordinary. It was reported that on 31Jan2021, Sunday afternoon, he noticed that he was starting to lose his memory. He said he suddenly forgot his age and had to ask his wife about it. He said he has consulted his doctor about this already, but still wants to give Pfizer a call to ask for advice on what to do. He also said he wants to go on record that he's having this kind of experience after receiving the vaccine. He said he has serious memory loss. It was bad Sunday afternoon and Monday morning but Monday afternoon it got better. The day before the report it was better but on the day of the report it is bad again. He went to see doctor regarding this; he hopes he doesn't lose his memory. He stated that on 01Feb2021 his brain has slowed down; his memory is gone. He went to see his primary care doctor, on 02Feb2021 he went to see another doctor, a brain doctor. He did a sleep test on 04Feb2021 with unknown results. The patient stated that he is still struggling with it. He has seen his doctor and is working on it but wanted to let Pfizer know about this and would like us to know the conditions and if Pfizer would have any information on this happening. The patient had blood tests and an MRI done on an unspecified date in 2021 with unknown results. The patient did not receive treatment for the events. The outcome of the events is not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/31/2021,2.0,UNK,,,Medical History/Concurrent Conditions: Heart valve replacement,,,"['Amnesia', 'Blood test', 'Cognitive disorder', 'Magnetic resonance imaging', 'Sleep study']",1,PFIZER\BIONTECH, 1042331,FL,66.0,F,"dizziness; fall; Swelling in arm; pain in arm; felt sleepy; weakness in the right eye; balance issues (falling into her right side); This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263; Expiration Date: May2021), via an unspecified route of administration in the right arm on 02Feb2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included cancer survivor, type 2 diabetes mellitus, and surgery of the left hand in 2020. Concomitant medications included the second dose of varicella zoster vaccine (shingles vaccine) (MANUFACTURER UNKNOWN) on 12Jan2021 for immunization. The patient previously received the first dose of the varicella zoster vaccine (shingles vaccine) (MANUFACTURER UNKNOWN) on an unknown date for immunization. On 02Feb2021, the patient experienced swelling and pain in arm and felt sleepy. On 03Feb2021, the patient fell on the table due to dizziness. The patient had to use her cane more to get around. On an unknown date in Feb2021, the patient had weakness in the right eye and balance issues (falling into her right side). The clinical outcomes of the dizziness, swelling in the arm, and weakness in the right eye were recovering; while that of the pain in the arm was not recovered. The clinical outcomes of the sleepiness, fall, and balance issues (falling into her right side), were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Cancer; Hand operation; Type II diabetes mellitus,,,"['Balance disorder', 'Dizziness', 'Extraocular muscle paresis', 'Fall', 'Pain in extremity', 'Peripheral swelling', 'Somnolence']",1,PFIZER\BIONTECH, 1042332,TN,26.0,F,"neurological symptoms most consistent with Parsonage-Turner syndrome.; neurological symptoms most consistent with Parsonage-Turner syndrome.; Worsening including increasing pain extending to all the arm; paresthesias throughout arm and hand,; feeling of dislocated scapula; tightening of the lateral aspect of the chest; sharp pain; The injection was incorrectly done too high and too deep into the joint/bursa. She developed sharp pain; This is a spontaneous report from a contactable physician. A 26-year-old female patient (daughter) (not preganent) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3302 and Expiration Date unknown) via Intramuscular on 18Jan2021 (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EH9899 and Expiration Date unknown) via Intramuscular on 30Dec2020 (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history was reported as none. The concomitant medications were not reported. No other vaccine in four weeks. The injection was incorrectly done too high and too deep into the joint/bursa. She developed sharp pain and started with neurological symptoms most consistent with Parsonage-Turner syndrome, which includes pain in the brachial plexus with weakness, paresthesia which might never resolve. This is an autoimmune disorder. Patient was worsening including increasing pain extending to all the arm, paresthesias throughout arm and hand, feeling of dislocated scapula, tightening of the lateral aspect of the chest. Onset date for all events was 18Jan2021 and resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered with treatment of oral steroids and nonsteroidal anti-inflammatory drugs (NSAID). No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the neurological symptoms, Parsonage-Turner syndrome and other reported events in the clinical context of wrong injection technique due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/18/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE,,,"['Chest discomfort', 'Joint dislocation', 'Neuralgic amyotrophy', 'Neurological symptom', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Wrong technique in product usage process']",2,PFIZER\BIONTECH,OT 1042333,VA,,F,"fatigue (sleeping most of the day)/tired; fatigue (sleeping most of the day); headaches; pain in her teeth like she has cavities; a color to her spit like gangrene; bad breath; kidney pain; urinary urgency; foul smell to urine; fever; feeling totally just like she had no blood in her body; as weak as a kitten; could not hardly get out of bed; felt sicker than having the virus; felt like she was going to fall out getting out of bed; making very poor decisions; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 28Jan2021 at a single dose for COVID-19 immunization. Medical history included SARS-CoV-2 infection (hospitalized for 3 days; quarantined at her assisted living facility for 14 days after discharge), gangrene (small intestine when she was younger), and lives at assisted living facility. The patient's concomitant medications were not reported. The patient experienced fatigue (sleeping most of the day)/tired, headaches, pain in her teeth like she has cavities, a color to her spit like gangrene, bad breath, kidney pain, urinary urgency, foul smell to urine, fever, feeling totally just like she had no blood in her body, as weak as a kitten, could not hardly get out of bed, felt sicker than having the virus, felt like she was going to fall out getting out of bed, and making very poor decisions on an unspecified date. All of the events were reported to have caused hospitalization. The clinical course was reported as follows: The patient received the vaccine five days after quarantine from previous COVID-19 infection. It was reported that she did not test positive for COVID-19 but did come down with the COVID-19 virus and was taken to the hospital immediately previously. She reported that she was currently taking unspecified antibiotics for the previous COVID-19 infection. The patient reports that she felt sicker since she got the vaccine than when she had the virus. She slept for 24 hours a day for 4 to 5 days, and only woke up to use the bathroom and when she got up, it felt like she was going to fall out. She also had a bad headache and just did not feel well. She was having really horrible headaches just prior to going to the hospital, some of the worst headaches she ever had. Her teeth, all of her teeth hurt, they just felt like if she pushed on them too much they would fall out; and it was like she had a toothache everywhere in her mouth. She felt really tired at the time of reporting as well. After she got the vaccine, she started feeling sick and was making very poor decisions about things. The clinical outcome of all of the events was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/28/2021,,,UNK,,,Medical History/Concurrent Conditions: Gangrene (small intestine when she was younger); Living in care; SARS-CoV-2 infection (hospitalized for 3 days; quarantined at her assisted living facility for 14 days after discharge),,,"['Asthenia', 'Breath odour', 'Fatigue', 'Feeling abnormal', 'Headache', 'Loss of consciousness', 'Loss of personal independence in daily activities', 'Malaise', 'Mental impairment', 'Micturition urgency', 'Pyrexia', 'Renal pain', 'Saliva discolouration', 'Somnolence', 'Toothache', 'Urine odour abnormal']",1,PFIZER\BIONTECH, 1042334,NE,31.0,M,"headache; Immediate injection location pain; left chest pain/Continuous left chest pain; Symptoms similar to migratory arthritis randomly occur from day two to four, mainly in both knees, left groin, and left wrist; This is a spontaneous report from a contactable Other Health Professional (patient). A 31-Year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL9262 and Expiration Date unknown) via Intramuscular on 03Feb2021 09:45 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included Hypertension. The concomitant medications was reported as Lisinopril. There is no other vaccine in four weeks. Immediate injection location pain and left chest pain on 03Feb2021 10:00. Continuous left chest pain and headache for about 12 hours on day one. Symptoms similar to migratory arthritis randomly occur from day two to four, mainly in both knees, left groin, and left wrist. The outcome of events was recovering without treatment was given. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Migratory arthritis cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/01/2021,,PVT,LISINOPRIL,,Medical History/Concurrent Conditions: Hypertension,,,"['Chest pain', 'Headache', 'Polyarthritis', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 1042335,SC,,F,"she has no immune system; pancytopenic; she was bleeding from everywhere; absolute neutrophil count is zero; her platelet count was at 1; white count fluctuates between 0.6 to 1.2, but its just low.; Methotrexate and infliximab for skin condition/received monoclonal antibody drug; Methotrexate and infliximab for skin condition/received monoclonal antibody drug; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included skin disorder. Concomitant medications included methotrexate for skin condition, infliximab for skin condition, she thought the dose was 10 mg per kg but she was not quite sure, she got it once per month, IV infusion. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization and experienced severe nausea and that went away on an unspecified date. She would have to try and figure out when her first dose was, she didn't remember the date but her nausea was 2 days later after the first dose and last for about 12 hours. She confirmed the nausea was recovered completely at this time. The patient was calling about the COVID vaccine. She was on REMICADE which was a monoclonal antibody drug and there was a specific question before the vaccine they asked if the patient was on a monoclonal antibody drug and she said that answer would always be yes for her. After her first COVID vaccine she had severe nausea and that went away, then when she had the second vaccine, 2 days later she was bleeding from everywhere and was pancytopenic, she had no neutrophils and she was wondering was anything being reported like this or why this could happen were there concerns of this. For event bleeding from everywhere, she did not remember what the date of the second dose was but symptoms started 2 days after the second dose. She confirmed 2 days later was when she noticed the bleeding. She said the bleeding was not happening right now (based on reporting date on 05Feb2021), she was in the hospital, she was not bleeding but she had no immune system. She said she was admitted twice so this was her second admission, the second admission was 01Feb2021 she had another admission a few days before that, she did not remember the dates of the admission but it was like an overnight stay. This was the second admission, she had been there since 01Feb2021 with this admission. She did not have her vaccine card, she could not get out of bed, the drugs they have her on made her looney and she didn't have anything she couldn't move. She said her absolute neutrophil count was zero and her platelet count was at 1. Her white count fluctuates between 0.6 to 1.2, but it's just low. She confirmed she would like to know if this had been reported with people on monoclonal antibody drugs and she just wanted to know what to do. The outcome of the event ""bleeding from everywhere"" was recovered on an unspecified date; of the other events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 (COMIRNATY) to the reported events cannot be excluded. Concurrent use of methotrexate and infliximab could be contributory. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,Y,,,,UNK,METHOTREXATE; REMICADE,,Medical History/Concurrent Conditions: Skin disorder,,,"['Haemorrhage', 'Immune system disorder', 'Neutrophil count', 'Neutrophil count decreased', 'Off label use', 'Pancytopenia', 'Platelet count', 'Platelet count decreased', 'Product use issue', 'White blood cell count', 'White blood cell count decreased']",2,PFIZER\BIONTECH, 1042336,,,F,"neuropathy in her left foot; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Jan2021, both at arm left via an unspecified route of administration at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced neuropathy in her left foot on an unspecified date after both doses (the second time worse). The patient outcome of the event was unknown. The information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,,,UNK,,,,,,['Neuropathy peripheral'],2,PFIZER\BIONTECH, 1042337,OH,35.0,F,"first dose on 22Jan2021 at 09:45 AM/ second dose on 05Feb2021; first dose on 22Jan2021 at 09:45 AM/ second dose on 05Feb2021; mild, intermittent neuropathy in left foot; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: Ej1686) via intramuscular on left arm on 22Jan2021 at 09:45 AM, and second dose of BNT162B2 (lot number: Em9810) via unspecified route of administration on left arm on 05Feb2021, both at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. The patient experienced mild, intermittent neuropathy in left foot. She experienced it first time on 29Jan2021 about a week after the first injection. Neuropathy got worse a day after the second dose. No treatment received for the event. No Covid prior vaccination. No Covid tested post vaccination. No other vaccine in four weeks and no other medications in two weeks. The outcome of the event was not recovered.; Sender's Comments: Based on temporal association and profile of the product, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to reported peripheral neuropathy cannot totally be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/29/2021,7.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Inappropriate schedule of product administration', 'Neuropathy peripheral', 'Off label use']",1,PFIZER\BIONTECH,OT 1042338,MD,61.0,F,"My brain, uterus and left foot toes became inflamed.; My brain, uterus and left foot toes became inflamed.; My brain, uterus and left foot toes became inflamed.; This is a spontaneous report from a contactable other health care professional (HCP) (patient). A 61-year-old female patient (no pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EN5318) on 02Feb2021 18:30 on left arm at a single dose for covid-19 immunisation. Facility type vaccine was Doctor's office/urgent care. Medical history included chronic kidney disease (CKD), multiple personality disorder (MPD), blood pressure abnormal. Known allergies: several BP meds and cholesterol lowing. If other vaccine in four weeks was no. Concomitant medications included nebivolol hydrochloride (BYSTOLIC), hydroxyurea, alopurinol. Patient experienced her brain, uterus and left foot toes became inflamed on 02Feb2021 19:30. It was like highlighting her problem areas. She was not sure to take the second shot. It happened after an hour after the shot and lasted within 5 minutes. No treatment was received. The outcome of the events was unknown. Events were considered non-serious per reporting other HCP.; Sender's Comments: The event Noninfective encephalitis most likelt an intercurrent condition and unrelated to suspect product bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/02/2021,0.0,PVT,BYSTOLIC; HYDROXYUREA; ALOPURINOL,,Medical History/Concurrent Conditions: Blood pressure abnormal; Chronic kidney disease; Drug allergy; Multiple personality disorder,,,"['Inflammation', 'Noninfective encephalitis', 'Uterine inflammation']",1,PFIZER\BIONTECH, 1042339,TN,,M,"some eye bleeding found on an exam; He had problem on his eyes; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program, Pfizer First Connect. A male patient of unknown age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date as a single dose in the left arm for COVID-19 vaccination. Medical history included and concomitant medications were not reported. The patient experienced had some eye bleeding and problem on his eyes after taking the first dose of the vaccine on an unknown date. The patient underwent lab tests and procedures which included an exam which discovered the eye bleeding a few days ago. The clinical outcome of the events eye bleeding and eye disorder was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Eye disorder', 'Eye haemorrhage', 'Investigation']",1,PFIZER\BIONTECH, 1042340,NC,,F,"Seizure; AFib; Terrible chills; Muscle pain where every muscle in her body hurt; shaking like crazy and could not stop; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified gender received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. On Sunday night, the patient had to go to ER because she was having terrible chills and was shaking like crazy and could not stop. It lasted 45 minutes. She went to the hospital. They kept her in emergency room. She had AFiB and had a seizure from it. She thought she was dying. After she had this and finally thought it might be a side effect from the injection. She did not know it was in the muscle and she had muscle pain. Thought she was getting beaten by a stick. All evens were in Jan2021. They also called 3 times for her to come back in to get the second dose. She was sure this was what caused it. Every muscle in her body hurt. At the time she did not know it was injected into the muscle. She did not want to go through this again. She wanted to know if she should get the second dose. Outcome of the event shaking like crazy and could not stop, Terrible chills was recovered on Jan2021. Outcome of the events Muscle pain where every muscle in her body hurt, AFib, Seizure was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/01/2021,,UNK,,,,,,"['Atrial fibrillation', 'Chills', 'Myalgia', 'Seizure', 'Tremor']",1,PFIZER\BIONTECH, 1042341,CT,,F,"vesicular rash that was pink, red, bumpy and painful on fingers on both hands after first and second vaccine; Vesicular rash that was pink, red, bumpy and painful on fingers on both hands after first and second vaccine; This is a spontaneous report from a contactable Other HCP. A 33-year-old female patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH) via an unspecified route of administration, the first dose on an unspecified date, then the second dose on 29Jan2021 at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. After the first vaccine, she got a vesicular rash that was pink, red, bumpy, and painful on her fingers. The same thing happened, but worse after the second dose on day 3. The reporter did not know if it was the same fingers both times. She did know it was a few fingers on both hands. The events were reported as medically significant. No other investigation assessment done. The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association and profile of the product, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to reported Rash vesicular and pain in extremity cannot totally be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Pain in extremity', 'Rash vesicular']",1,PFIZER\BIONTECH, 1042342,NY,72.0,M,"cold and clammy; kept clearing his throat; blood sugar was 245; blood pressure 175/111; Runny nose; it could have been a delayed allergic response; This is a spontaneous report from a contactable nurse reporting for husband. A 72-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Feb2021 10:15 right arm at single dose for protection from virus. Medical history included diabetes from 2005 and ongoing, partial gastrectomy from Jul2016, stroke from 2015, allergic to various things, dementia. Prior Vaccinations (within 4 weeks): None. Patient previously received Shingrix vaccine (first dose) and experienced a similar reaction (have to clear his throat), flu or hepatitis vaccines and not had a reaction. The patient experienced cold and clammy, kept clearing his throat, blood sugar was 245, blood pressure 175/111, runny nose on 04Feb2021 02:00. Clinical course reported as: Her husband had the vaccine at 10:15am. She gave him some Advil. Sixteen hours later at 2:00am her husband was cold, clammy and diaphoretic. He was having to clear his throat. He did have a little dementia and was diabetic. His blood sugar was 245. His blood pressure was 175/111 and he had a runny nose. He did not have any chest pain. He was unable to explain what was happening. She checked his blood pressure again manually and the results were the same. She gave him another blood pressure pill though it was out of the usual time. Gradually his blood pressure came down. The diastolic stayed over 100 for the evening. The systolic came down. She kept trying to read but was unable to find information. She thought it could have been a delayed allergic response. She was going to take him to the hospital but took care off him herself. She gave him a Benadryl and it calmed him down. He was feeling better and was able to fall asleep. Her husband had a Shingrix vaccine (first dose) this summer and had a similar reaction (have to clear his throat). He went to the hospital and they monitored him. They said it was not because of the vaccine. Her husband has not had a reaction in the past to vaccines. He has had every kind of vaccine with no reaction. He has not had a reaction to the flu or hepatitis vaccines. Outcome of events cold and clammy, kept clearing his throat, blood sugar was 245, blood pressure 175/111, runny nose was recovered on 04Feb2021. Events cold and clammy, kept clearing his throat, blood sugar was 245, blood pressure 175/111, runny nose were reported as serious medically significant. Events cold and clammy and kept clearing his throat was classified as related to suspect vaccine. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association and profile of the product, the contributory role of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to reported events cannot totally be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/04/2021,1.0,PVT,,Diabetes,Medical History/Concurrent Conditions: Allergy (allergic to various things); Dementia; Partial gastrectomy; Stroke,,,"['Blood glucose', 'Blood glucose abnormal', 'Blood pressure abnormal', 'Blood pressure diastolic', 'Blood pressure measurement', 'Blood pressure systolic', 'Cold sweat', 'Hypersensitivity', 'Oropharyngeal discomfort', 'Rhinorrhoea']",1,PFIZER\BIONTECH, 1042343,NY,42.0,F,"could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself. This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Acute sinusitis; Allergic to cats; Allergic to dogs; Allergy to molds; Heart murmur; Herbal allergy; Pollen allergy,,,"['Body temperature', 'Chills', 'Dizziness', 'Dysgeusia', 'Dysphagia', 'Feeling abnormal', 'Headache', 'Lymphadenopathy', 'Musculoskeletal pain', 'Palpitations', 'Paraesthesia oral', 'Paralysis', 'Pyrexia', 'Rash erythematous', 'Swollen tongue', 'Urticaria']",2,PFIZER\BIONTECH, 1042344,AZ,75.0,F,"Rapid heart rate, atrial fibrillation episode after both first and second dose. I have occasional/rare atrial fibrillation. This episode was directly after each dose. Heart rate elevated to 140 bpm; Rapid heart rate, atrial fibrillation episode after both first and second dose. I have occasional/rare atrial fibrillation. This episode was directly after each dose. Heart rate elevated to 140 bpm; This is a spontaneous report from a contactable pharmacist (patient). A 75-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 16:30 (the first dose, lot number: EL3249) at single dose; via an unspecified route of administration on 03Feb2021 (the second dose, lot number: EL9264) at single dose, both in left arm for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy (HCM) and the patient had myectomy surgery for Hypertrophic Obstruction Cardiomyopathy in 1993. Concomitant medications included paracetamol (TYLENOL), verapamil hcl, simvastatin, apixaban (ELIQUIS). No covid prior vaccination and no covid tested post vaccination. The patient had no known allergies. The patient had rapid heart rate, atrial fibrillation episode after both first and second dose. The patient had occasional/rare atrial fibrillation. This episode was directly after each dose. Heart rate elevated to 140 bpm, lasting 12 hours after 1st dose, 17 hours after 2nd dose. The patient underwent lab tests and procedures which included heart rate was elevated to 140 bpm in Jan2021 and Feb2021. No treatment was received. The outcome of the events was recovered in Jan2021 after first dose and recovered in Feb2021 after second dose.; Sender's Comments: Based on available information, a possible contributory role of the subject drug BNT162B2 cannot be excluded for the reported events Atrial fibrillation and Heart rate high. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,UNK,TYLENOL; VERAPAMIL HCL; SIMVASTATIN; ELIQUIS,,Medical History/Concurrent Conditions: Hypertrophic cardiomyopathy; Hypertrophic obstructive cardiomyopathy; Myomectomy,,,"['Atrial fibrillation', 'Heart rate', 'Heart rate increased']",1,PFIZER\BIONTECH, 1042345,FL,73.0,M,"Facial paralysis Bells' Palsy; This is a spontaneous report from two contactable consumers (including patient himself). A 73-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in the left arm on 18Jan2021 11:30 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. He was not diagnosed with COVID prior to vaccination. The patient received other medications in two weeks but had not received other vaccine in four weeks. The patient experienced facial paralysis Bells' Palsy on 03Feb2021 08:00. No treatment was received for the event but the event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered. The patient had not been COVID tested post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,02/03/2021,16.0,OTH,,,,,,['Facial paralysis'],1,PFIZER\BIONTECH, 1042346,,,F,"Seizures; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history included epilepsy. The patient's concomitant medications were not reported. The patient hadn't had seizures in 3 years but 36 hours later from receiving her first dose, she had her first seizure after 3 years. Outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Epilepsy,,,['Seizure'],1,PFIZER\BIONTECH, 1042347,,,F,"Miscarriage; This is a spontaneous report from a contactable consumer(patient). This is a maternal report. A female patient of an unspecified age (Age: 29; Unit: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that her first dose of the Pfizer vaccine was on 15Jan2021 and reported that she had a miscarriage on Thursday 04Feb2021. It was reported that the patient missed her scheduled second dose of the Pfizer COVID-19 vaccine due to a miscarriage. The event was assessed as serious (medically significant). The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,02/04/2021,20.0,UNK,,,,,,['Abortion spontaneous'],1,PFIZER\BIONTECH, 1042351,NC,67.0,M,death,Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/16/2021,5.0,UNK,synthroid,mild liver disease,,,none,['Death'],1,MODERNA,SYR 1042353,CA,84.0,F,Rapid and irregular heartbeat Taken to hospital emergency room Treated Remained 8 hours until heart stabilized,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/04/2021,02/05/2021,1.0,OTH,Celebrex Metaprolol,,Irregular heart beat Lung issues,,,"['Condition aggravated', 'Heart rate increased', 'Heart rate irregular']",UNK,MODERNA, 1042374,CA,44.0,F,"Vasovagal syncope after getting up to urinate, hit head with loss of consciousness for 10-15 minutes, sustained concussion, admitted overnight for testing and observation.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/30/2021,01/31/2021,1.0,PVT,"Atenolol 25mg daily, Levothyroxine 75 mcg daily, Cymbalta daily, Lexapro 10 mg daily, Benadryl 25 mg PRN (taken at 4:50 am for itching caused by Norco), Norco 5/325 mg PRN (taken at 4:50 am for pain)",,Postural Orthostatic Tachycardia Syndrome (POTS),,"PCN, Erythromycin, Sulfa drugs, latex, chloroquine","['Blood calcitonin normal', 'Blood culture negative', 'Blood electrolytes normal', 'Computerised tomogram head normal', 'Computerised tomogram neck', 'Concussion', 'Culture urine negative', 'Echocardiogram normal', 'Electrocardiogram normal', 'Fibrin D dimer normal', 'Full blood count normal', 'Head injury', 'Liver function test normal', 'Loss of consciousness', 'Syncope', 'Troponin normal']",2,MODERNA,IM 1042387,LA,77.0,F,Pt. recieved 1st dose of Moderna vaccine on 3 Feb and presented to the ED with syncopy on 4 Feb. Patient was discharged on 7 Feb. Home course unknown,Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/03/2021,02/04/2021,1.0,PVT,,,depression,,"AMOXICILLIN-POT Clav; ATORVASTATIN; BACLOFEN; CAffeine, cipro, DABIGATRAN ETEXILATE; DECONGEST TABS; ERYTHROMYCIN; FLECAINIDE; FLUOXETINE; GABAPENTIN; LISINOPRIL; LOSARTAN; MORPHINE; OXYMETAZOLINE; RIVAROXABAN; SULFAMETHOXAZOLE",['Syncope'],1,MODERNA,IM 1042388,OK,78.0,M,TONGUE/LIP EDEMA 15 MINUTES POST INJECTION,Not Reported,,Yes,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PUB,Amiodarone Coumadin,None reported,"Cardiovascular disease, Atrial Fibrillation",,"Anaphylaxis- Aspirin, Penicillin, Toradol, Codeine, Percocet, Beclovent, Biaxin","['Lip oedema', 'Tongue oedema']",2,PFIZER\BIONTECH,IM 1042412,FL,83.0,F,"Days 3, 4, 5, 6: Inability to move head in any direction (up/down or L/R) without SEVERE pain. Neck unable to support head unless directly above shoulders. Leaning forward slightly to sit or stand up caused unbearable pain. Unable to lift head from pillow to roll over. Could only swallow food, if neck muscles held tightly with hand to prevent movement. Severe pain caused Vasovagal syndrome fainting. Asymptomatic fever 99.7-100.5 for Days 3, 4, 5. No chills, weakness or aching. Day 7: In A.M., slightly increased head movement possible for first time without pain. By P.M. even better, but still only very limited movement of a few inches possible. Improved daily thereafter. Day 15 (today): Mild stiff neck persists.",Yes,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/07/2021,2.0,OTH,"Avapro, Synthroid, Vit.D, Multivitamin, Calcium, AREDS2,Biotin",None,Mild Hypertension Macular Degeneration,,NKA,"['Headache', 'Muscular weakness', 'Musculoskeletal stiffness', 'Pain', 'Presyncope', 'Pyrexia', 'Syncope']",1,PFIZER\BIONTECH,IM 1042447,FL,36.0,F,Intense pain at the injection site and radiating down right arm for 24 hours after the injection. 72 hours after injection paralysis of right wrist possible radial nerve damage.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/10/2021,02/17/2021,7.0,PVT,"Mvi, ambien, probiotic, doxepin, aczone top, differin gel, Zofran,",None,IBS,,No known allergies,"['Injection site pain', 'Pain', 'Pain in extremity', 'Paralysis']",2,MODERNA,IM 1042458,CA,77.0,M,"Patient admitted with acute stroke, no prior history of same. Mild hyperlipidemia, but otherwise no clear risk factors for stroke. Unclear if anything to do with COVID vaccine.",Not Reported,,Not Reported,Yes,4.0,Yes,N,01/26/2021,02/16/2021,21.0,PVT,"Eye drops for glaucoma, omeprazole",None,Glaucoma,,None,"['Angiogram', 'Cerebral infarction', 'Cerebrovascular accident', 'Computerised tomogram head', 'Hyperlipidaemia', 'Magnetic resonance imaging brain abnormal', 'Thrombosis']",UNK,MODERNA, 1042526,CA,68.0,F,"Moderna COVID-19 Vaccine EUA. Monday, 2-15-21. 11:45 am. ? Received first dose of Moderna Covid-19 vaccine. 12:30 pm. ? Headache developed. 8:00 pm. ? Watching TV noted irregular heartbeat, and a minute later, increase in respiration rate. That lasted 20 minutes at the most, and then went away. Went to bed at 10 pm and slept well. Tuesday, 2-16-21. 7:00 am. ? In kitchen. Lightheaded, increased respiration, feeling like I?m going to pass out, so I quickly sit down. Two minutes later feel fine. Went about making breakfast. This happened two more times. Realizing this might be a reaction to the vaccination, went to urgent care. Doctor listened to my heart, ordered EKG and result showed that I was in atrial fibrillation (A-Fib). NO previous cardiac issues, no high blook pressure, no diabetes, never a smoker, not obese. Ambulance was called to take me to Hospital. Another EKG confirmed still in A-Fib. Blood drawn. Hooked me up to a wireless/remote heart monitor. Still in A-Fib, elevated heart rate, higher than normal blood pressure. Kept overnight in hospital awaiting more test results, continuous monitoring, and with ECG ordered for Wednesday morning and then consultation with cardiologist. Wednesday, 2-17-21. 11:45 am., ECG done. Still in A-Fib. ECG shows no signs of blood pooling or clotting. Cardiologist proposed courses of action, starting with what makes sense based on current conditions: A cardioversion. Having done thousands (his words) and given my great state of health otherwise, and very low risk for complications, a cardioversion is agreed to. That would happen immediately after first doing a Tee (transesophageal echocardiography) to look at the back of my heart. Then if all looks clear, no clotting, proceed with the cardioversion procedure. 3:00 pm., anesthesiologist asks if I have any further questions. I didn?t. He sedates me. At 3:17 pm. I open my eyes, see the cardiologist standing at the foot of the gurney giving me thumbs up. I returned the thumbs up and said to him, ?good job.? Heartbeat successfully restored to normal rhythm by the cardioversion procedure. 6:00 pm. (approximately) - Discharged from hospital with prescription for Eliquis and Lopressor, and instructions for follow up appointments with primary care physician, and with cardiologist.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/15/2021,02/15/2021,0.0,PHM,"NO prescription medications. Dietary supplements: apple cider vinegar, vitamin C, 81 mg aspirin 3x per week, biotin, Centrum Silver multivitamin, vitamin D3, Co-Q10, fish oil capsules, kelp capsule, magnesium malate, melatonin, glucosamine",None. In great health.,"NONE. No diabetes. A1c 5.4. High-sensitivity C-reactive protein 0.8. No high blood pressure issues, no prior cardiac issues, never a smoker, very occasional alcohol. Rarely get sick.",,"No known allergies to medications, food, or products. Seasonal allergies in the springtime when pollen count is high.","['Atrial fibrillation', 'Blood test', 'Cardiac monitoring abnormal', 'Cardioversion', 'Dizziness', 'Echocardiogram', 'Electrocardiogram abnormal', 'Headache', 'Heart rate increased', 'Heart rate irregular', 'Hypertension', 'Respiratory rate increased']",UNK,MODERNA,IM 1042574,NJ,60.0,M,"Right after the injection, I felt an electric shock feeling in my hand. This was followed by right hand numbness and tingling in the entire hand. This symptoms of numbness and tingling decreased in severity, but now has been stable: every day, I am experiencing numbness of the right hand, extending from my wrist and involving my palm and my pinky and ring finger. The feeling is not decreased by Tylenol.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/23/2021,01/23/2021,0.0,PVT,Lisinopril Aspirin Tylenol,None,Hypertension Sleep apnea Asthma,flu vaccination with erythema at site left arm - age 60,Compazine Cipro NSAIDs,"['Hypoaesthesia', 'Immediate post-injection reaction', 'Paraesthesia']",1,MODERNA,IM 1042579,LA,77.0,F,Pt. recieved COVID vaccine on 4 Feb and came to hospital on 5 Feb with Chest pain; Elevated troponin; Exertional chest pain; Symptomatic bradycardia. Admitted for ACS and being treated with heparin. syncopal eisode. she was discharged on 9 Feb. Home course unknown,Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/04/2021,02/05/2021,1.0,PVT,,,,,CIPROFLOXACIN,"['Bradycardia', 'Chest pain', 'Syncope', 'Troponin increased']",2,PFIZER\BIONTECH,IM 1042619,LA,86.0,M,Pt. recieved 1st dose of Moderna vaccine on 5 Feb and presented to the ED with new onset AFIB & abdominal pain on 5 Feb. Patient was discharged on 17 Feb. Home course unknown,Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/05/2021,02/05/2021,0.0,PVT,,,,,CODEINE; CYCLOBENZAPRINE,"['Abdominal pain', 'Atrial fibrillation']",1,MODERNA,IM 1042629,FL,40.0,M,Shap pain and severe arm weakness post injection. Continues with sharp pains in left upper arm and shoulder along with numbness. Arm and hand grip weak at times as well,Not Reported,,Not Reported,Not Reported,,Yes,N,12/28/2020,12/30/2020,2.0,PVT,Omeprazole 40mg daily,,,,"Doxycycline allergy, shrimp","['Grip strength decreased', 'Injection site hypoaesthesia', 'Injection site pain', 'Muscular weakness']",1,MODERNA,IM 1042636,WI,74.0,M,Left CVA Right sided numbness vision loss 2/16/2021,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/02/2021,02/16/2021,14.0,PUB,Yes Atorvastatin Fish Oil Avalide Baby ASA Metoprolol Norvasc,Hx prostate cancer 2001 Essential HTN 2012 Mixed Hyperlipidemia 2017 Chronic Kidney Disease Right Thyroid Nodule DM with renal manifestations,see item 11,,Lactose Intoller,"['Blindness', 'Cerebrovascular accident', 'Hypoaesthesia']",1,PFIZER\BIONTECH,IM 1042639,LA,84.0,M,"Pt. recieved COVID vaccine on 6 Feb @0730 and presented to the hospital with chest pain & quesionable stroke. + CT and transferred to another hospital @ 1430, appears CVA (cerebral vascular accident); Cardioembolic stroke; Cerebrovascular accident (CVA), unspecified mechanism; TIA (transient ischemic attack). He was discharged on 10 Feb. Home course unknown",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/06/2021,02/06/2021,0.0,PVT,,,,,Tramadol,"['Cerebrovascular accident', 'Chest pain', 'Computerised tomogram abnormal', 'Embolic stroke', 'Transient ischaemic attack']",2,PFIZER\BIONTECH,IM 1042692,MO,40.0,F,"Sever joint pain, headache Hives on the backside of not of my legs with itching that turned into large welts a few hours later that then turned into 2 large welts on the side/back of my upper thighs. 2 days later and ever since I have severe nerve pain that is constant and is affecting my ADLs.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/21/2021,01/23/2021,2.0,PVT,"Taltz, Gabapentin, tramadol, Advil",Nothing acute,Psoriatic arthritis,,Dairy intolerance,"['Arthralgia', 'Headache', 'Loss of personal independence in daily activities', 'Neuralgia', 'Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,IM 1060522,,87.0,M,"death Narrative: 86 year old MALE with PMH of Afib s/p AICD/PPM, HFrEF (EF< 20% 10/2019), DM2, HTN, HLD, BPH, Depression. Was stable and feeling well when he was administered Covid-19 vaccine on 02/17/2021- Pfizer COVID-19 Vaccine 0.3 ml IM. MVX (Manuf); PFR; Lot#; EL9267; Exp Date:05/31/2021 Administration Anatomic site: Right Deltoid; Pt was monitored for 30 minutes after administration and had no adverse effects. He was called later in the day and reports he feels well and has had no adverse reactions, he endorsed his arm is a little sore at injection site. ON 02/19/2021- his dghter found him on the floor, next to his bed, dead. She reported on 2/19/2021- that she was out with him to dinner on 2/18/2021, and he stated he did not feel well, that his insides did not feel right. He proceeded to have dinner and 2 drinks. HE was doing ok, when she took him home.",Yes,02/19/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/19/2021,2.0,OTH,,,,,,"['Death', 'Feeling abnormal', 'Injection site pain', 'Malaise']",UNK,PFIZER\BIONTECH,IM 1060523,,93.0,M,"contracted covid after first dose Narrative: First covid vaccine dose 12/31/2020, tested positive for covid 1/7/2021, died from complications 1/25/2021",Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/25/2021,25.0,OTH,,,,,,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1042712,CA,39.0,M,"On January 1 and 2nd, approximately 10 days following administration of Moderna vaccination, I began to experience both hearing loss and tinnitus in my right ear. The hearing loss and ringing noise in my right ear came on rather slowly, and progressed over a week's time. There was no illness otherwise, and no trauma. The ringing continued, and I sought out medical care from both Neurology and Otolaryngology. My otolaryngologist could not find any cause and speculated that it could in fact be from the vaccination. I underwent oral steroid treatment as well as a series of 3, sequential weekly steroid injections into my middle ear space, though my tympanic membrane. I also started taking oral L-Lysine at the recommendation of my neurologist as well as other herbals including oral flavonoids to help reduce tinnitus. None of the above treatments have made any improvement in my symptoms. I had my hearing rechecked every week at ENT office and the same degree of hearing loss is evident. None of which has returned to date. I have most recently just last week begun to a pursue hearing aid device at the recommendation of my ENT physician. I am currently scheduled for brain MRI to make sure there is not another physiologic cause such as a tumor or hemangioma on my nerve that would possible explain my new symptoms in the right ear. That study is not completed yet. The hearing loss and tinnitus is constant, and unchanged, now nearly 7 weeks. The noise is significant and disturbs my sleep, and much of my daily function.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/22/2020,01/02/2021,11.0,PVT,Omega-3. DHA 1280/day Vit D 2000IU/ day,none,once or twice a month headache.,,sulfa,"['Audiogram', 'Deafness unilateral', 'Loss of personal independence in daily activities', 'Sleep disorder', 'Tinnitus']",1,MODERNA,IM 1042757,IL,59.0,F,"On January 16th I started feeling very dizzy in my eyes got blurry very dry mouth and palpitations, and I almost passed out at home, my husband had to take me to Er. They wanted to keep me in the hospital but I told him I will follow up with my doctor on Monday, I did not want to stay on the floor with covid patients the test that they had ordered at the hospital were normal they did not order a CMP they only did a basic metabolic panel and that was normal, so I followed up with my doctor on Monday which was January 18th, and she ordered CMP and all the labs, when they threw my blood my liver enzymes were very elevated over the thousands LT ASG and the and others, then the doctor ordered a second set of blood works of CMP just to make sure it wasn't a fluke, they were even more elevated they were over 1,400.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/13/2021,01/16/2021,3.0,WRK,No,No,No,,No,"['Aspartate aminotransferase increased', 'Blood lactic acid increased', 'Dizziness', 'Dry mouth', 'Hepatic enzyme increased', 'Jaundice', 'Metabolic function test', 'Palpitations', 'Ultrasound abdomen', 'Vision blurred']",2,PFIZER\BIONTECH,IM 1042766,AZ,75.0,M,First fever and body aches day 2. On day 5 developed a stroke and later developed Bell's Palsy. Hospitalized because of this. Currently moved to a rehab hospital.,Not Reported,,Yes,Yes,5.0,Yes,N,02/10/2021,02/15/2021,5.0,PVT,"Warfarin, Levemir, Humalog, Losartan",,"Diabetes, Valley Fever, High Blood Pressure",,Penicillin,"['Blood test', 'Cerebrovascular accident', 'Computerised tomogram', 'Facial paralysis', 'Magnetic resonance imaging', 'Pain', 'Pyrexia']",1,MODERNA,IM 1042780,FL,57.0,F,"Slight Abdominal pain 0400 2/2/21. Loss of appetite. Severe abdominal pain 1400. Went to ER. Surgery and ruptured appendix 2/2/21 at 2130. Resulting in peritonitis, seven day hospital stay, multiple antibiotics, elevated abnormal labs including LFT and platelets. ,",Not Reported,,Yes,Yes,7.0,Not Reported,N,01/29/2021,02/02/2021,4.0,PVT,"Baby ASA, calcium, magnesium, zinc, Krill oil, Vit D",None.,"Allergies, seasonal. History of basal cell and melonoma.",,"Sulfa, peanuts","['Abdominal pain', 'Appendicitis perforated', 'Computerised tomogram', 'Decreased appetite', 'Laboratory test abnormal', 'Liver function test increased', 'Peritonitis', 'Platelet count increased', 'Surgery']",1,PFIZER\BIONTECH,IM 1042801,TN,56.0,M,"""Moderna COVID-19 Vaccine EUA"" Hypersensitivity & fleeting / flowing pains spread throughout left side of body from tip of nose across face, up and down neck and left side of head out through fingers of left hand, down left side of back, down left thigh / leg and out through toes of left foot. It was as if the left side of my body was in a different time zone than the right side. I called the nurse line; they suggested a visit to the ER. My BP was way up, and I panicked just a little; but, tried to use my mindfulness practice to observe the unfolding events, rather than being consumed by them. There was a CT of my skull wherein they found indications of ""an old"" stroke; so, they decided that it was possible I had a stroke. I was transferred from the Medical Center to the Stroke Center at the Medical Center under the care of Dr. Another CT with contrast and a MRI confirmed ""OLD"" stroke, but nothing new. I was assured the vaccine had nothing to do do with my symptoms, and that I most likely experienced a Trans Ischemic Attack (TIA), and that the situation was merely a coincidence as they believe the vaccine had nothing to do with the TIA. However, based on my personal experience of the events as they unfolded, it is my sincere belief that the vaccine was incidental to the effects as I experienced them. I was kept overnight for further observation, released the next day, and had a follow-up with my primary care physician at the Med Center. I am now taking an 81 mg aspirin, Plavix, and 80 MG Clopidogrel as a precaution, and my symptoms have been gradually fading away.",Not Reported,,Yes,Yes,1.0,Not Reported,N,02/10/2021,02/10/2021,0.0,OTH,? Budesonide 3 mg ? Levothyroxine (Synthyroid) 150 mcg ? Liothyronine (Cytomel) * 5 mcg ? Escitalopram Oxalate (Lexapro) 10 mg ? Simvastatin (Zocor) 20 mg ? Mon,,"Hypothyroidism, high blood pressure, high cholesterol, overweight, IBS-D, anxiety / depression",,Allergies and Adverse Reactions Summary This lists Allergies and Adverse Reactions that you entered and in your record at Medical Centers. Date Entered Allergen/Reactant Reaction/Side Effect Location Source 03/13/2015 LISINOPRIL 03/13/2015 ZITHROMAX RASH 03/13/2015 ZYBAN 09/08/2014 CODEINE 09/08/2014 SULFA DRUGS,"['Computerised tomogram head abnormal', 'Echocardiogram', 'Hypersensitivity', 'Magnetic resonance imaging abnormal', 'Pain', 'Scan with contrast', 'Transient ischaemic attack']",1,MODERNA,SYR 1042821,TN,18.0,M,"Hypothermia. Four days after second dose body temp dropped to 94 degrees F. Evaluation for sepsis was unremarkable. CBC was normal, blood cultures were negative. Hypothermia was treated with warming devices. Increased seizure activity was noted. Keppra was started for increased seizure activity. Hypothermia resolved with resolution of the seizures.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/15/2021,02/18/2021,3.0,PVT,"Famotidine, Carafate, gabapentin, baclofen, Culturelle, multivitamin, levalbuterol, atrovent, Flovent, Clonidine, scopalamine",,"Chronic lung disease, hypertension, seizure disorder, scoliosis, anoxic brain injury",,Ciprofloxacin,"['Activated partial thromboplastin time normal', 'Blood culture negative', 'Body temperature decreased', 'Condition aggravated', 'Full blood count normal', 'Hypothermia', 'Metabolic function test', 'Prothrombin time normal', 'Seizure']",2,PFIZER\BIONTECH,IM 1042899,OK,66.0,M,"12/21/2020 I had my first Pfizer COVID-19 vaccine and the second on 1/13/2021. Two days after my second vaccine on 1/15/2021 at 8:50 PM I had a scintillating scotoma in my right visual field in both eyes consisting of a bright flash of light in the center of my visual field that cleared but then it expanded into a C-shaped series of zig-zag lines that slowly expanded into the periphery of both right visual fields. It ended at 9:20 PM. I had no headaches afterward. While I have had migraines when I was younger, I haven?t had one in several decades and I never had an aura before it. I went to the ED where I was evaluated for a possible TIA and then admitted into Hospital. While there my platelet count was 400% of what it usually was. Other than the platelet count and anemia (I donated 2 unit of packed red blood cells on 12/17/2020) the rest of my blood work was unrevealing. The scintilating scotoma only lasted 30 minutes but the elevated platelets (although slowly coming down) continues to this day.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/13/2021,01/15/2021,2.0,OTH,finasteride 5 mg metoprolol ER 50 mg spironolactone 25 mg losartan 25 mg omprazole20 mg,none,benign prostatic hyperplasia ectopic atrial tachycardia hypertension,"prolonged pain at injection site from vaccine administered too high in shoulder (3-4 months), age 65, 10/10/2019, high dose quad",Bactrim (sulfamethoxazole / trimethoprim) doxycycline aspartame,"['Anaemia', 'Blood creatinine increased', 'Carotid artery stenosis', 'Computerised tomogram normal', 'Echocardiogram normal', 'Haemoglobin decreased', 'Magnetic resonance imaging brain normal', 'Metabolic function test', 'Metabolic function test normal', 'Photopsia', 'Platelet count increased', 'Scintillating scotoma', 'Serum ferritin normal', 'Ultrasound Doppler', 'Visual field defect']",2,PFIZER\BIONTECH,IM 1042905,FL,35.0,F,"2 weeks after second dose of vaccine received I noticed my left eye lazy and loss of taste and feeling on left side of my tongue . As the day progressed I noticed my left side of face felt different number , my mouth was not opening wide on left side . I did a telemedicine call with a Dr that referee me to Er where I was diagnosed with Bell Palsy.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/05/2021,02/18/2021,13.0,PVT,No,No,No,,No,"['Ageusia', 'Amblyopia', 'Facial paralysis', 'Hypoaesthesia oral']",1,PFIZER\BIONTECH,SYR 1042915,FL,52.0,M,"Guillain-Barr� syndrome. So far hospitalized =X 7 days, on day 3 of IV IG with ICC line, then planned 3 days of high dose soleumedrol, then plasmapheresis Auto-immune hepatitis",Not Reported,,Yes,Yes,7.0,Yes,N,01/25/2021,02/10/2021,16.0,PVT,"Valtrex 500 BID, Benicar 40 QD, 81 ASAS QD, Vitamin Ds 15000U daily",None,"HTN, alpha one antitrypsin carrier (MS phenotype)",,PCN,"['Autoimmune hepatitis', 'Blood test', 'Guillain-Barre syndrome', 'Immunoglobulin therapy', 'Magnetic resonance imaging']",2,MODERNA,IM 1042967,VA,87.0,M,"Patient called son around 6:30am on 2/18/21. When son tried to contact patient around 8:30am, he was not able to get a hold of patient. Son sent someone over to check on patient. They found patient on the floor. He was coherent at first but then lost consciousness. It believed he experienced a stroke sometime around 8:30-9:00am of 2/18/21. Patient was taken to hospital and then transferred to another hospital. He was put in a medically induced coma. He passed between 4:00 and 4:30 pm on 02/19/21.",Yes,02/19/2021,Not Reported,Yes,1.0,Not Reported,N,02/13/2021,02/18/2021,5.0,PHM,Tylenol,Sinus infection,"Hypertension, Diabetes",,None,"['Cerebrovascular accident', 'Death', 'Loss of consciousness', 'Medical induction of coma']",1,MODERNA,IM 1043099,GA,46.0,F,"24-48 hours after receiving dose, had low grade fever, headache, and malaise. On Tuesday morning (3 days after vaccine), woke up with vertigo, visual changes, severe nausea, diagnosed with cerebrovascular accident",Not Reported,,Yes,Yes,2.0,Yes,N,02/13/2021,02/16/2021,3.0,PVT,Protonix Metformin XR Effexor Lexapro Multivitamin,None,"PCOS, GERD, anxiety",,Latex,"['Angiogram', 'Cerebrovascular accident', 'Computerised tomogram head', 'Echocardiogram', 'Headache', 'Magnetic resonance imaging brain', 'Malaise', 'Nausea', 'Pyrexia', 'Vertigo', 'Visual impairment']",2,PFIZER\BIONTECH,IM 1043123,WI,65.0,F,Death,Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/06/2021,9.0,PUB,Unknown,Positive COVID-19 PCR collected postmortem,"Hypertension, COPD, T2DM, Obesity",,Unknown,['Death'],1,MODERNA,IM 1043280,VA,87.0,M,TIA like symptoms roughly 3 weeks after administration,Not Reported,,Not Reported,Yes,,Not Reported,Y,01/30/2021,02/16/2021,17.0,PVT,"Aspirin, metoprolol, Norvasc, Tylenol, Lipitor, senna, multivitamin",None,"Hypertension, hyperlipidemia, coronary artery disease",,None,['Neurological symptom'],UNK,MODERNA, 1043292,OH,54.0,F,"I have a complete timeline of my series of events. I believe the Moderna, dose 1 may have contributed to my current medical diagnosis of severe Cardiomyopathy, EF 12, L bundle branch block. I would like for someone to look into this possibility. I am an O positive individual who has never been positive for CoVid-19. I have also been anti-body tested twice with no positive antibody results. Please call me if there is any relationship for cardiomyopathy and the Moderna vaccine. I have done a lot of research and am seeking any further information to help with my present medical condition.",Not Reported,,Yes,Yes,1.0,Not Reported,N,01/26/2021,02/02/2021,7.0,OTH,"Apple cider vinegar, b-complex vitamin, calcium, ceterizine, hctz 50mg po qd, Avapro 300mg po qd, Asa 325mg po qd, Myrbetiq 25mg po qd, tumeric oral, zinc oral.","Sinus, allergies-mold, Diastolic Htn",Diastolic Htn,,Allergy to PCN,"['Bundle branch block left', 'Cardiomyopathy', 'Catheterisation cardiac', 'Echocardiogram', 'Laboratory test']",1,MODERNA,IM 1043302,TX,73.0,M,My dad received the Pfizer vaccination on 2/5/21. He was admitted into the hospital the next day for C-Diff bacterial infection. He had been on dialysis treatments for kidney failure treatment since 2017 and had recently been diagnosed with stage 3 colon cancer in June 2020. He had completed his final treatment of chemotherapy on 2/4/21 and several weeks prior had been determined cancer free. On Tuesday 2/9/21 he was released from the hospital and went home. Early Thursday morning 2/11/21 @ approximately 1:30 am CST his eyes rolled back in head and he stopped breathing and was non responsive. My mother called 911 and attempted CPR. Paramedics arrived and were able to successfully get a pulse then transferred him to the hospital. He was put on a ventilator @ the hospital and then transferred to a different hospital a few hours later. He lost pulse/heartbeat several times @ the 2nd hospital he was transferred to. We were not allowed to travel with him or see him b/c of all of the COVID restrictions. We were communicating with the ICU doctor by phone who ultimately communicated to us that there was nothing further that could be done to save his life. He subsequently passed away @ approximately 8:55 am CST on 2/11/21.,Yes,02/11/2021,Yes,Yes,1.0,Not Reported,N,02/05/2021,02/06/2021,1.0,UNK,,,Kidney failure - dialysis treatment 3x per week Recently recovered from stage 3 colon cancer,,,"['Cardiac arrest', 'Clostridium difficile infection', 'Death', 'Eye movement disorder', 'Intensive care', 'Mechanical ventilation', 'Pulse absent', 'Renal failure', 'Respiratory arrest', 'Resuscitation', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,SYR 1043325,FL,63.0,F,Chills comes and goes but not like it was Exhaustion still prolonging Stabbing head pain for the most part has resolved Sensitive teeth,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/08/2021,01/08/2021,0.0,OTH,Propranolol,Multiple Sclerosis,,,,"['Chills', 'Fatigue', 'Headache', 'Hyperaesthesia teeth']",UNK,MODERNA, 1043326,TX,68.0,F,"2 days after the vaccine, I started having severe pain in my knees down my legs. I'm on day 17 and it is at times unbearable. My knees don't want to bend. I can't take an anti-inflammatory because I'm on a blood thinner. So far just taking Tramadol and Tylenol Arthritis. Doesn't touch the pain. Still working with doctor to figure out what to do next.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/02/2021,02/04/2021,2.0,PVT,"Vit D, Magnesium, Zinc, Quercetin, CoQ10, OccuForce, Berbe, Hawthorne Berry, Metoprolol, Eloquis, Amlodopine",none,Afib,,none,"['Arthralgia', 'Mobility decreased', 'Pain in extremity']",UNK,PFIZER\BIONTECH,SYR 1043336,CA,82.0,M,"2/6 (vaccine given): No side effects. 2/7: mild fever and chills (expected), weakness, low appetite 2/8: Severe weakness and fatigue, subjective fever/chills, low appetite, nausea, in evening diarrhea started. 2/9: Symptoms not improved in the morning. Went to ED. Hospital stay: Dehydration, give IV fluids. Continued symptoms, plus vomit and diarrhea with blood. Placed on clear liquid diet. GI consult. Diagnosed with duodenitis and gastritis. Started on oral PPI, no improvement in symptoms, switched to IV PPI. Vomiting resolved after a few days. Stool cultures all negative. Onset sore throat (possible reflux/esophagitis). Confirmed gastritis, gastric erosions. Fevers recurred. Consult with ID, possible TB, placed on isolation. Blood cultures and stool cultures all negative. AFB negative x2 (results of 3rd AFB pending as of today). Rheumatology consult for continued fevers, weakness, fatigue. Started on prednisone ~2/15, fevers resolved soon after. Severe weakness (bed bound), fatigue, low appetite, and diarrhea throughout hospital stay. Started on Megace and Immodium with slight improvement in appetite and diarrhea, respectively. 2/19: ALT and ALT increased, prednisone was dc'd (received 4 of 5 day treatment of prednisone). Crestor held. Anticipate dc for PT/rehab once LFTs are back to baseline.",Not Reported,,Not Reported,Yes,11.0,Not Reported,U,02/06/2021,02/06/2021,0.0,UNK,"rosuvastatin, benazepril, metoprolol, finasteride, xalatan, tylenol codeine 300/30, garlic, vitamin C, bilberry,",,"Hypertension, rheumatoid arthritis, hyperlipidemia, CAD s/p 2 stents, BPH, glaucoma, cataracts s/p surgery,",,Penicillin,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Asthenia', 'Bedridden', 'Blood culture negative', 'Chills', 'Computerised tomogram abdomen', 'Computerised tomogram thorax abnormal', 'Culture stool negative', 'Decreased appetite', 'Dehydration', 'Diarrhoea', 'Diarrhoea haemorrhagic', 'Duodenitis', 'Endoscopy normal', 'Fatigue', 'Full blood count normal', 'Gastritis', 'Gastritis erosive', 'Laboratory test normal', 'Mycobacterium test negative', 'Nausea', 'Oropharyngeal pain', 'Patient isolation', 'Pulmonary mass', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting', 'White blood cell count normal']",1,MODERNA,IM 1043349,FL,53.0,F,"I received the second dose of Moderna on 2/18/21 at approximately 1:30 pm. I felt fine the rest of the day but my arm was sore and I wasn't able to sleep on my right side as a result of getting the vaccine in my right deltoid. It felt like my right arm was attacked by hammers because it was so sore.The next day (2/19/21) I had muscle soreness, chills, and felt tired and ""out of it"". I took an ibuprofen (400 mg) at 1:30 pm on 1/19/21 and felt immediately better. My arm where I got the injection was still sore and I noticed when I changed my hosptial scrubs my arm was red and swollen at 3 pm and had a rash. I took a50 mg benadryl at 5 pm and woke up and my lips were swollen. I could feel the tip of my tongue feel like my lips ""like they were going to sleep"" and tingly. I went to the ER.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/18/2021,02/19/2021,1.0,PVT,"Dr. Fuhrman's women multi vitamins, D Fuhrma Immune bioprotect, Dr. Fuhrman LDL Biotect, Dr. Fuhrman Ultra Cell Biotect, Cholestoff",None,None,Possibly- had a tetanus booster in 12/20 and sore arm and lips were swollen but not as bad as with the covid 19 moderna vaccinat,"Thimerisol, quantawrium 15","['Chills', 'Erythema', 'Fatigue', 'Feeling abnormal', 'Hypoaesthesia oral', 'Lip swelling', 'Myalgia', 'Pain in extremity', 'Paraesthesia oral', 'Peripheral swelling', 'Rash', 'Sleep disorder']",2,MODERNA,IM 1043358,DC,72.0,F,Guillain Barre Syndrome,Not Reported,,Not Reported,Yes,3.0,Yes,N,02/14/2021,02/15/2021,1.0,PVT,Multivitamin,Viral conjunctivitis Macular papular rash cause unknown,Breast Cancer Hypothyroidism,,,"['Guillain-Barre syndrome', 'Lumbar puncture', 'Magnetic resonance imaging spinal']",UNK,MODERNA,SYR 1043383,NC,49.0,F,"I am not sure if this is related or not, but 15 days after my 2nd Pfizer dose I started having Vertigo. I continue to have vertigo. I saw my doctor on January 27 and we tried steroids, lorazepam, and phenergan. I saw a physical therapist for vertigo and continue to do exercises to treat vertigo. I did have a previous incidence of vertigo a couple weeks after a flu vaccine about 3 years ago. I just wanted to report my symptoms as the Covid vaccine is new. I have currently not recovered from this episode of vertigo and cannot work at this time.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/09/2021,01/24/2021,15.0,WRK,Gralise Cymbalta Wellbutrin Remicade Ultram,,Peripheral neuropathy Rheumatoid Arthritis,,Latex Ancef,"['Impaired work ability', 'Vertigo']",2,PFIZER\BIONTECH,IM 1043482,PR,62.0,M,"Noted red blotchy areas 2 days post vaccination on bilateral inner thighs. Patient states he has yellow drainage if he expresses the areas. Has a photo of the rash. They are circular individual areas about 1 cm circumference. Each individual area is bright red with a open pinpoint area in the center. Some have a crusty area. He denies itching, burning. Denies rash in any additional areas post vaccination. Referred to see physician.",Yes,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/05/2021,2.0,PUB,"lisinopril,",none,HTN and cardiac disease,,NKDA,"['Drainage', 'Erythema', 'Haemangioma of skin', 'Purulent discharge', 'Rash', 'Rash macular', 'Scab']",1,MODERNA,IM 1043570,IL,45.0,M,Patient suffered ICH within 24 hours of receiving COVID vaccine. Symptoms include facial droop and mild dysarthria. Admitted to Neuro ICU for monitoring.,Not Reported,,Not Reported,Yes,5.0,Yes,U,02/18/2021,02/19/2021,1.0,PVT,OTC naproxen,Right Shoulder dislocation (2/14/2021),20 pack year smoker,,NKDA,"['Basal ganglia haemorrhage', 'Coma scale normal', 'Computerised tomogram head abnormal', 'Dysarthria', 'Facial paralysis', 'Haemorrhage intracranial', 'Intensive care', 'NIH stroke scale score increased']",1,PFIZER\BIONTECH,IM 1043573,MN,73.0,F,Asa result of dizziness the patient fell unwitnessed. Resident was sent to the ER with low O2 Saturation <90,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/18/2021,02/18/2021,0.0,SEN,"B Complex Cap, Basaglar Inj 100 unit Suib Q daily, Diltiazem 240mg oral daily, Docusate/Senna 50-8.6mg Oral BID, DOK 100mg daily, Donepezil 5mg Daily, Erythromyiacin Ointment daily, Incuse ELPT INH 62.5mcg daily, Isosorb MN 30 mg ER & Tab d",,Osteoporosis Unknown Not Set Zoster Unknown Not Set Chronic Kidney Disease Stage III Unknown Not Set A-fib Unknown Not Set HTN Unknown Not Set Diabetes Mellitus Type II Unknown Not Set CHF Unknown Not Set Depressive Disorder Unknown Not Set,,Simvastatin,"['Dizziness', 'Fall', 'Oxygen saturation decreased']",2,MODERNA,IM 1043607,TX,75.0,F,Heart went into v tac rhythm,Not Reported,,Yes,Yes,3.0,Not Reported,Y,01/01/2021,01/01/2021,0.0,UNK,,,Congestive heart failure,,,['Ventricular tachycardia'],2,MODERNA,IM 1043690,ID,76.0,M,Ventricular fibrillation/sudden death,Yes,02/19/2021,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,PVT,Aspirin 325 mg 1 tab po daily Lisinopril 5 mg 1 tab po daily Metoprolol succinate 50 mg 1 tab po bid Sotalol 120 mg 1.5 tab po bid Alfuzosin 10 mg 1 tab po daily Myrbetriq 50 mg 1 tab po daily Diltiazem 240 mg 1 tab po daily Rosuvastatin 40,,"HLD, GERD, OSA, rosacea, pulmonary HTN, HTN, CAD, hx of prostate cancer, sinus node dysfunction, aortic stenosis, diastolic dysfunction, cardiac pacemaker",,Amiodarone - pulmonary toxicity Lipitor - rash Penicillins - mild hives Adhesive tape/silicones - rash,"['Sudden death', 'Ventricular fibrillation']",1,PFIZER\BIONTECH,IM 1043716,CT,40.0,M,"Patient woke up at 4am on Feb. 14th 2021 with extreme headache, nausea, dizziness, and blurry vision. patients wife called 911 and patient was taken to Hospital ER for emergency evaluation. CT scan revealed a brain bleed. patient was rushed to Hospital Neuro ICU for immediate care. patient was at Hospital from Sunday Feb. 14th - Tuesday Feb. 16th. patient blood pressure (which is usually well controlled) had spiked up to dangerous level and caused a rupture to an AVM in the tegmentum region of his brain. hospital treated patient and got his blood pressure regulated. Patient discharged on Tuesday Feb. 16th 2021 with the expectation of making a full recovery after several weeks of rest.",Not Reported,,Yes,Yes,3.0,Not Reported,N,02/10/2021,02/14/2021,4.0,PVT,"Metformin HCL 1000MG, Levothyroxine 150MCG, Lisinopril 40 MG, Escitalopram 10 MG, Atorvastatin 20MG",none,"Diabetes, hypothyroidism, high blood pressure, anxiety",,none,"['Angiogram', 'Arterial rupture', 'Arteriovenous malformation', 'Blood pressure increased', 'Blood test', 'Cerebral haemorrhage', 'Computerised tomogram head abnormal', 'Dizziness', 'Headache', 'Intensive care', 'Magnetic resonance imaging', 'Nausea', 'Vision blurred']",2,PFIZER\BIONTECH,SYR 1043740,PA,49.0,F,"After receiving COVID-19 Moderna vaccine dose 1 on 1/28/2021, came down with headache and soreness in left arm the next day. Throughout the night on Saturday, 1/31/2021 began having stiff neck and left side, including arm and leg, became weak with numbness throughout. The numbness was mostly felt in fingers and toes of left side. These symptoms continued and progressively became worse throughout the following week 1/31/2021-2/8/2021. In addition to the left side symptoms worsening, numbness and weakness developed in the right side fingers and toes. On 2/8/2021 numbness and weakness in left side became so bad that left leg was very heavy and dragging when trying to walk. I was unable to work that day and was told to call Employee Health. Employee Health directed me to go to the Emergency Room. While at the Emergency Room, I received lab tests, XRay, EKG, CT Scans, and MRI of neck. MRI was evaluated by Neuro/Orthopedic Surgeon who diagnosed me with Cord Compression Myelopathy and told me that I needed immediate urgent surgery. ER Doctor, Neuro/Orthopedic Surgeon and Hospitalist all felt that the COVID-19 vaccine could have caused the inflammatory immune response that led to further cord compression. I had anterior cervical discectomy and fusion (ACDF) surgery on 2/11/2021. The hope of the ACDF surgery was to stop further progression of the symptoms of numbness and weakness, but was not guaranteed to restore normal function of the left side. I am currently still experiencing numbness and weakness in left side postoperatively.",Not Reported,,Not Reported,Yes,3.0,Yes,N,01/28/2021,01/31/2021,3.0,PVT,"Vyvanse, Vitamind D-3, Fish Oil, Advair",None,"Asthma, Chronic Neck Pain, Post Concussive Syndrome, ADHD, Fatty Liver",,None,"['Blood test', 'Computerised tomogram', 'Condition aggravated', 'Electrocardiogram', 'Gait disturbance', 'Headache', 'Hemiparesis', 'Hypoaesthesia', 'Impaired work ability', 'Intervertebral disc operation', 'Limb discomfort', 'Magnetic resonance imaging neck', 'Magnetic resonance imaging spinal abnormal', 'Musculoskeletal stiffness', 'Myelopathy', 'Pain in extremity', 'Spinal cord compression', 'X-ray']",1,MODERNA,IM 1043776,NY,92.0,M,"Patient with severe muscle weakness with tremulousness 3 days post-vaccination, and subsequently patient developed new onset seizure like activity on 2/20/2021 around 3:30 pm requiring admission to the hospital for further evaluation and monitoring. All events occurred within the 14-day period post vaccination.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/13/2021,02/20/2021,7.0,PVT,Glargine Metoprolol Levothyroxine Furosemide Gabapentin Tamsulosin,No acute conditions,HTN BPH DM2 Hypothyroidism HLD CKD IV,,NKDA,"['Acute kidney injury', 'Chronic kidney disease', 'Muscular weakness', 'Seizure like phenomena', 'Tremor']",2,MODERNA,IM 1043783,AZ,39.0,F,Facial numbness/paralysis started 10 minutes after injection. Paralysis of tongue and jaw muscles followed an hour later. Paralysis of eyelids followed. Medical staff on-site were not informed on how to proceed and recommend to take a benadryl and sleep it off. Muscle function returned 12 hours later.,Not Reported,,Not Reported,Not Reported,,Yes,Y,01/19/2021,01/19/2021,0.0,UNK,Prozac,,Lupus,,,"['Facial paralysis', 'Hypoaesthesia', 'Tongue paralysis']",1,PFIZER\BIONTECH,SYR 1043808,TX,51.0,F,"Itching began about 12 hours after the second injection. Followed by moderate patchy hives. Treated with OTC Benedryl, Pepcid, and Zyrtec. Had a decrease in itching and mild improvement in the rash. At about 26 hours post-vaccination itching and severe hives developed a sought treatment in the emergency department for severe hives, severe itching, throat swelling, and hoarseness in voice. Was treated with solu-medrol, Pepcid, and Benedryl. Sent home with steroids and Benedryl. Then on 2/20/2021 began to develop throat swelling and voice hoarseness again. Sought the emergency room again for the same treatment list above.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,PVT,"Vitamin C, D3, magnesium oxide, Prempro",none,Diabetic and migraines,,"Tomatoes, Egg, erythromycin, Bactrim DS, and Phenergan","['Dysphonia', 'Pharyngeal swelling', 'Pruritus', 'Rash', 'Urticaria']",2,PFIZER\BIONTECH,IM 1043828,CA,91.0,F,"Trigeminal neuralgia pain on right side of face occurred next day after vaccination. Became very severe without being able to talk, drink or eat on 2/11. Went to ER on 2/12. Discharged on 2/14. Still be in pain and unable to eat solid food.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/08/2021,02/09/2021,1.0,UNK,"carbamazepine, benazepril, fluoxetine, lumigan, prednisolone, senna, magnesium, vitamin D3",,"trigeminal neuralgia, glaucoma, high blood pressure.",,,"['Aphasia', 'Condition aggravated', 'Feeding disorder', 'Fluid intake reduced', 'Pain', 'Trigeminal neuralgia']",1,MODERNA, 1043831,OH,44.0,F,Patient suffered a heart attack on 2/17/2021,Not Reported,,Yes,Yes,,Not Reported,N,02/16/2021,02/17/2021,1.0,SEN,Unknown,Nothing acute that I am aware of,History of cancer; history of heart disease; diabetes; kidney problems,,Unknown,['Myocardial infarction'],2,PFIZER\BIONTECH,IM 1043880,IN,59.0,F,"Pt received second Moderna COVID-19 vaccination administered in left arm at her assisted living facility by Pharmacist at 1153 on 2/19/2021. Pt was monitored for vaccine reaction with no known adverse reaction. Approximately 18 hours post-vaccine, she was found deceased in her sleep at 0540 on 2/20/21. Per circumstances/pt history, it is presumed that the patient aspirated while sleeping, perhaps secondary to a seizure. Coroner was notified and declined as coroner's case. VAERS notification being made due to pt death within 24 hours of receiving a vaccine.",Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,SEN,"atorvastatin, Vit D3, Vit B12, Plavix, duloxetine, Gabapentin, glipizide, levothyroxine, tolterodine, verapamil, atropine, Flonase, Symbicort, Invega, loperamide, Tylenol, albuterol sulfate",urinary tract infection,"diabetes mellitus with polyneuropathy, schizoaffective disorder, chronic obstructive pulmonary disease, essential hypertension, bipolar disorder, hypothyroidism, history of cerebral infarction, diabetic retinopathy, overactive bladder, Vitamin D deficiency, encephalopathy, chronic kidney disease, seizures",,"iodine, shellfish","['Aspiration', 'Death', 'Insomnia', 'Seizure']",2,MODERNA,IM 1043887,NY,76.0,F,"Dose 1 of Covid19 Pfizer vaccine administered 12/30/20 & dose 2 of Covid19 Pfizer vaccine administered 1/20/21. Patient tested positive for Covid19 on 2/12/21 in the nursing and during hospital admission on 2/18/21. Patient with severe respiratory distress, on Remdesivir since 2/18/21.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,12/30/2020,02/18/2021,50.0,SEN,unknown,,"HTN, COPD, HLD, gastritis, stage 2 DU, IDA, major depression",,unknown,"['COVID-19', 'Respiratory distress', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 1043932,WA,78.0,M,"Developed expressive aphasia TIA 15 hours post vaccination, requiring 48 hour hospitalization",Not Reported,,Yes,Yes,2.0,Not Reported,Y,02/17/2021,02/18/2021,1.0,PVT,"Lisinopril, Hydrochlorothiazide, allopurinol, metformin, pioglitazone,",None,"Hypertension, diabetes, COPD",,None,"['Aphasia', 'Transient ischaemic attack']",UNK,PFIZER\BIONTECH,IM 1043948,HI,23.0,M,"PT EXPERIENCED NAUSEA, HA, FATIGUE 1 DAY POST VACCINE. REPORTS HE FELT BETTER 2 DAYS POST VACCINE AND WENT FOR A REGULAR WORK-OUT WITHOUT COMPLICATIONS. PT WOKE-UP 3 DAYS POST VACCINE WITH CHEST PX, SOB, FATIGUE. HE CALLED 911 AND WAS BROUGHT TO HOSPITAL VIA AMBULANCE. PT HAD UNREMARKABLE EKG INITIALLY, LABS DRAWN. INITIAL TROPONIN 4.7, EKG REPEATED WITH SOME MINIMAL ST ELEVATION, 324MG ASA GIVEN. COORDINATING TRANSPORT TO ANOTHER HOSPITAL WITH CARDIOLOGY SERVICES, TROPONIN REPEATED AND FOUND TO BE 10.8 WITH GLOBAL ST ELEVATIONS ON EKG. PT TRANSPORTED TO HOSPITAL FOR PRESUMED PERICARDITIS. AWAITING UPDATES ON PT CONDITION TOMORROW.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/18/2021,02/21/2021,3.0,MIL,NONE,NONE,NONE,,NONE,"['Blood creatine phosphokinase increased', 'Chest X-ray normal', 'Chest pain', 'Dyspnoea', 'Electrocardiogram ST segment elevation', 'Electrocardiogram normal', 'Fatigue', 'Headache', 'Nausea', 'Pericarditis', 'SARS-CoV-2 test negative', 'Troponin increased']",2,MODERNA,IM 1044063,MO,72.0,F,a few hours after the vaccine my left hip started hurting severely and unrelentingly. Can barely walk and am using a wheelchair. Has not improved in the 5 days since then.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/16/2021,02/16/2021,0.0,PHM,"multivitamin, glucosamine, eye vitamin, vit C, Vit D",,L hip arthritis with bone spurs,,"codeine, pain meds","['Arthralgia', 'Gait disturbance', 'Wheelchair user', 'X-ray of pelvis and hip']",1,MODERNA,IM 1044071,NE,38.0,F,"I had a major stroke on 12/25/2020, 9 days after receiving the vaccine. I had a clot in my MCA. My left arm was completely flaccid, with left facial droop and garbled speech. Thankfully I was able to receive TPA that day, which resolved all of my symotoms.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,12/16/2020,12/25/2020,9.0,PVT,2000 iu Vitamin D3 Multivitamin,None,Hx: Hodgkin's Lymphoma (remission),,None,"['Angiogram', 'Atrial septal defect', 'Atrial septal defect repair', 'Cerebrovascular accident', 'Computerised tomogram', 'Disorganised speech', 'Echocardiogram', 'Electrocardiogram', 'Facial paralysis', 'Laboratory test', 'Magnetic resonance imaging', 'Monoplegia', 'Thrombosis', 'Ultrasound Doppler']",1,PFIZER\BIONTECH,IM 1044078,ME,35.0,F,"Syncope I was treated for a split lip, severe neck pain, pinched nerve resulting in L arm paralysis Muscle relaxers and pain killers were prescribed Arm movement returned after about 3 weeks",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/13/2021,01/14/2021,1.0,PVT,Trazadone for sleep Albuterol Flovent,none,none,,none,"['Electroencephalogram normal', 'Lip injury', 'Magnetic resonance imaging normal', 'Monoplegia', 'Neck pain', 'Nerve compression', 'Syncope', 'X-ray normal']",2,PFIZER\BIONTECH,IM 1044102,OH,77.0,M,"Shortness of Breath causes by multiple large blood clots, put on blood thinners, seems to be fine, but has follow up appointment in March",Not Reported,,Yes,Yes,1.0,Not Reported,U,02/09/2021,02/15/2021,6.0,PHM,"Multivitamins, Fish oil, Asprin 81mg, vitamin c 1000mg",,N/a,,Hayfever and perservatives,"['Dyspnoea', 'Electrocardiogram abnormal', 'Thrombosis', 'Ultrasound Doppler']",1,PFIZER\BIONTECH,IM 1044185,VA,57.0,F,"She received 2nd COVID vaccine on 1/7//21. On 1/13/21, she developed sore throat, earache, dizziness, dyspnea, diarrhea, vomiting and fever. She required hospitalization on 1/18/21 for Acute hypoxic respiratory failure secondary to bilateral Pneumonia with left pleural effusion. Sepsis secondary to Gram-Positive bacteremia (strep pneumococcus). UTI. Acute Kidney Injury",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/07/2021,01/13/2021,6.0,PVT,Buspar; Effexor; Melatonin; Metoprolol; Zantac; Zyrtec,,"Heart murmur, GERD, Reactive Airway disease;, Mood Disorder",,"Adhesives, Sulfa Drugs","['Acute kidney injury', 'Bacteraemia', 'Diarrhoea', 'Dizziness', 'Dyspnoea', 'Ear pain', 'Oropharyngeal pain', 'Pleural effusion', 'Pneumonia', 'Pyrexia', 'Respiratory failure', 'Sepsis', 'Urinary tract infection', 'Vomiting']",2,PFIZER\BIONTECH,IM 1044197,KY,76.0,M,"RECEIVED 1ST DOSE OF PFIZER COVID VACCINE ON 02/14/21. ON 02/20/21 REPORTED ED FOR GENERALIZED WEAKNESS, FATIGUE. , AND NAUSEA/VOMITING/DIARRHEA AND BEING UNABLE TO EAT SINCE YESTERDAY. ON 02/20/21 ADMITTED INPATIENT TO HOSPITAL WITH DIAGNOSIS OF ELEVATED TROPONIN AND GENERALIZED WEAKNESS.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/14/2021,02/20/2021,6.0,PVT,,,,,SULFA ANTIBIOTICS,"['Asthenia', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram pelvis abnormal', 'Computerised tomogram thorax normal', 'Diarrhoea', 'Fatigue', 'Feeding disorder', 'Fibrin D dimer increased', 'Nausea', 'SARS-CoV-2 test negative', 'Scan with contrast', 'Troponin increased', 'Vomiting', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1044206,OK,45.0,F,"within 24 hours began to experience severe abdominal pain and diarrhea. within 72 hours had bloody diarrhea and full crohns flare up. Nausea. Extreme fatigue . has lasted over 6 weeks now. at two week mark noticed numbness in hands and feet that continued to spread over the next month. was dropping items cause lost hand strength, Cold all the time and realized when I accidentally burned myself I could not feel pain on my skin anywhere. 2nd degree burn on arm legs and torso 2 weeks after vaccine which is what really made me aware of the neurological issues after the vaccine. These neurological symtoms have increased to involve both hands and both feet and part of palms and arch of feet. Numbness and pins and needles feeling all the time now. do not know if nerve stuff will be permanent or not. had to go on fmla due to disability related to this.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/24/2020,12/25/2020,1.0,WRK,"Duragesic, Tylenol, Prevacid, B12 vitamins",Just chronic pain I have had due to previous surgeries and degenerative disc disease.,"Crohns disease no flare ups for 10 years until now, interstitial lung disease, degenerative disc disease, kidney stones, Endemetrosis",,"Remicaid, stadol, zofran, IV iron, imitrex, Sulfa drugs","['Abdominal pain', 'Condition aggravated', ""Crohn's disease"", 'Diarrhoea', 'Diarrhoea haemorrhagic', 'Fatigue', 'Feeling cold', 'Grip strength decreased', 'Hypoaesthesia', 'Impaired work ability', 'Laboratory test', 'Nausea', 'Neurological symptom', 'Paraesthesia', 'Sensory loss']",1,MODERNA,SYR 1044226,KY,90.0,M,"RECEIVED BOTH MODERNA COVID-19 VACCINES ON 01/19/21 & 02/16/21 (NO LOT#, ROUTE, OR LOCATION PROVIDED IN EPIC CHARTING). 02/18/21 CALL TO CARDIOLOGIST TO REPORT CHEST PAIN RADIATING TO LEFT ARM THAT HAD BEEN GOING ON X2 HOURS. HE ALSO DESCRIBED HIGH BLOOD PRESSURE AND THAT HE HAD RECEIVED HIS 2ND COVID VACCINE 2 DAYS PRIOR. CARDIOLOGIST RECOMMENDED HE GO TO ER FOR CONTINUED PAIN. PATIENT REPORTED PAIN HAD ENDED. 02/19/21 REPORTED TO ER WITH CHEST PAIN AND ELEVATED BLOOD PRESSURE. DIAGNOSED WITH CHEST PAIN, UNSPECIFIED TYPE AND HYPERTENSION NOT AT GOAL.. 02/19/21 ADMITTED INPATIENT TO HOSPITAL..",Not Reported,,Not Reported,Yes,,Not Reported,U,02/21/2021,02/19/2021,,PVT,,,,,IODINATED DIAGNOSTIC AGENTS NIACIN PENICILLINS MORPHINE SHELLFISH- DERIVED PRODUCTS PNEUMOCOCCAL VAC POLYVALENT ROSUVASTATIN,"['Chest pain', 'Hypertension']",1,MODERNA, 1044247,OH,84.0,F,Moderna COVID 19 Vaccine: Patient started with symptoms of covid 5 days after first vaccine. She was hospitalized and passed due to COVID 19 on 2/6/21. Patients family informed us when she was due for the second dose.,Yes,02/06/2021,Not Reported,Yes,,Not Reported,N,01/21/2021,01/26/2021,5.0,PHM,,,,,,"['COVID-19', 'Death']",1,MODERNA,IM 1044252,IL,68.0,M,"""This message is to inform patient that you have been successfully scheduled for your first dose of the Pfizer COVID-19 vaccine. You are scheduled to receive the vaccine on Saturday February 13, 2021 at 12:45 PM."" Almost immediately after, I was ro take my wife for her 1st dose (Saturday February 13, 2021 at 2:15 PM); however, I was already disoriented and had trouble picking her up. My wife called police to try and find me. When I finally go home, I couldn't remember anything of the events of the day. The following morning (Sun. Feb. 14th) @7:00AM, I collapsed in the kitchen and 911 was called as my heart stopped. 10 minutes passed by and I was turning blue. I still can not remember getting the vaccine or any of the events of 02/13/2021.",Not Reported,,Yes,Yes,7.0,Not Reported,Y,02/13/2021,02/13/2021,0.0,SCH,ARMOUR THYROID 90MG LYRICA 75MG NOVALOG 100U/ML PEN 10 units TESTOSTERONE CYPIONATE .1ml TRESIBA 3 ML U-100 PEN 32 units ASPIRIN 81mg ALPHA LIPOIC ACID 600mg. B-1 (Thiamine) 500mg B-12 (Methylcobalamin) 1000mcg C 1000mg C,None,"T1 Diabetes, Hypothyroidism, Triple Bypass (02/06/3019) fully recovered.",,None,"['Cardiac arrest', 'Cyanosis', 'Disorientation', 'Implantable defibrillator insertion', 'Intensive care', 'Memory impairment', 'Syncope']",1,PFIZER\BIONTECH,IM 1044256,KY,83.0,M,"RECEIVED 1ST DOSE OF PFIZER COVID-19 VACCINE ON 02/12/21 ON 02/20/21 REPORTED TO ED AFTER BECOMING LIGHT HEADED AND HAVING A SYNCOPAL EPISODE. REPORTED SOME SOA ON EXERTION THAT DEVELOPED EARLIER THAT DAY. ON 02/20/21 PT ADMITTED INPATIENT TO HSOPITAL WITH DIAGNOSIS OF SYNCOPE AND COLLAPSE, AOMMUNITY AQUIRED PNEUMONIA, ACUTE COLITIS, AND LEUKOCYTOSIS.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/12/2021,02/20/2021,8.0,PVT,,,,,PENICILLIN,"['Chest X-ray', 'Clostridium test positive', 'Colitis', 'Computerised tomogram head', 'Computerised tomogram thorax', 'Dizziness', 'Dyspnoea exertional', 'Leukocytosis', 'Pneumonia', 'Syncope', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1044267,TX,54.0,M,"38 hours after vaccination I woke in the middle of the night with extreme abdominal pain, dizziness, and severe diarrhea. This continued for 2 hours. I lost 6 pounds. After continuing with some diarrhea all day on February 12th, I began having bloody mucous chunks as my stool. I was advised by my doctor to go to the ER. I was diagnosed with colitis in the ER and was admitted for several days for treatment due to the severe blood coming out. CT scan showed severe inflammation, and stool sample showed blood and lactoferrin marker high. I was given many antibiotics and fluids and was released home on February 14th, 2021. I am still receiving treatment with oral antibiotics, and appointments with my physician. I had to be absent from work for over 7 days.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/10/2021,02/12/2021,2.0,OTH,"Trulicity 1.5, Lisinopril, Rouvastatin, Metformin",None,"Diabetes, High Blood Pressure, High Cholesterol",,None,"['Abdominal pain', 'Colitis', 'Computerised tomogram abnormal', 'Diarrhoea', 'Dizziness', 'Haematochezia', 'Impaired work ability', 'Inflammation', 'Laboratory test', 'Mucous stools', 'Stool analysis abnormal', 'Weight decreased']",1,PFIZER\BIONTECH,SYR 1044298,CO,69.0,F,"Had Moderna COVID vaccine approximately 1pm on 2/17. Developed headache and right visual field loss approximately 8pm on 2/18. Presented to our hospital at 5pm on 2/19 with progression of aforementioned symptoms and found to have left intraparenchymal hemorrhage with midline shift. Her symptoms are currently stable. Our neurosurgical team is not planning any surgical intervention. MRI of her brain demonstrates potential amyloid deposits, which are likely causative.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/17/2021,02/18/2021,1.0,PVT,"levothyroxine, sertraline, cholecalciferol",none,hypothyroidism,,atorvastatin,"['Amyloidosis', 'Angiogram cerebral', 'Arteriogram carotid', 'Brain midline shift', 'Cerebral haemorrhage', 'Computerised tomogram head', 'Headache', 'Magnetic resonance imaging brain abnormal', 'Visual field defect']",1,MODERNA,IM 1044302,WA,81.0,F,"Pt began feeling poorly, low energy after 24 hours. Increasingly short of breath, not really communicating clearly, enough that I (her daughter recommended that the Dr come. He sent for the paramedics due to low oxygen and something not being quite right. AT hospital multiple tests were run and bacterial pulmonary pneumonia along with heart failure exacerbation was diagnosis. She had been in her room for 2 weeks prior, with no contact with the outside world.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,02/12/2021,02/14/2021,2.0,SEN,"Insulin, Atorvastatin, Buspirone, Digoxin, Furosemide, Metolezone",none,"Congestive heart failure, diabetes",,None,"['Asthenia', 'Cardiac failure', 'Communication disorder', 'Condition aggravated', 'Dyspnoea', 'Malaise', 'Oxygen saturation decreased', 'Pneumonia bacterial']",2,PFIZER\BIONTECH,SYR 1044303,NM,59.0,F,"Anaphylaxis reaction. Shot given around 9am. Around 11am symptoms appeared: extremely hot/flushed, nauseated, felt ill, difficulty swallowing. Went to pharmacist who had me sit down, within 30 seconds could not swallow. Pharmacist injected me with Epi Pen and called 911. Paramedics arrived gave more epinephrine, oxygen, started breathing treatment. Lost my voice as throat started to tighten more. Taken to Hospital where I was given Benadryl, steroids, stomach meds, more fluids and another breathing treatment since my lungs were so tight, I could only take shallow breaths. The crated my lungs, did blood work and kept me overnight for observation because I have a history of secondary reactions when I experience anaphylaxis. I was released from the hospital on 2/20/2021 at 2pm.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,02/19/2021,02/19/2021,0.0,SEN,Levothyroxine 100mcg Magnesium 1000 mg Vitamin D3 5000 IU Multivitamin Exederin Migraine,None,Hypothyroidism,,"Codeine (causes hallucinations) Inhaled solvents like nail polish, spray paint, etc (anaphylaxis reaction)","['Anaphylactic reaction', 'Aphonia', 'Blood test', 'Chest X-ray', 'Chest discomfort', 'Dysphagia', 'Hot flush', 'Hypopnoea', 'Malaise', 'Nausea', 'Throat tightness']",2,MODERNA,SYR 1044352,IL,64.0,M,"Stomach upset, sudden heart failure, death",Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/14/2021,6.0,UNK,Synthroid; Cosentix; Multivitamin; Vitamin C; Omeprazole; Loratadine,None,Psoriatic Arthritis; Hypothyroidism,,None,"['Abdominal discomfort', 'Cardiac failure', 'Death']",1,MODERNA,UN 1044358,CA,54.0,M,"12/28/20 I woke up with a fever, chills, body ache. I went and got tested for Covid19. 12/29/20, I was informed I tested positive. 3 weeks of rest, over the counter medicine- nightquil, cold ez, Mucinex. Prescription inhaler.",Not Reported,,Yes,Not Reported,,Not Reported,Y,12/22/2020,12/25/2020,3.0,PVT,"complara, Zyrtec, doxocin, oxybutynin, famciclovir, finasteride, Lipitor, multi vitamins.",none,hiv positive,,cefdinir,"['COVID-19', 'Chills', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH,IM 1044420,TN,36.0,M,"Please reference separately submitted MIS-A form. He had sore throat, high fever, diarrhea, deteriorating in to multisystem failure and apparent acute myocarditis, notably with relative initial sparing of the lungs. He suffered cardiac arrest in radiology after developing aphasia and was transferred to Hospital after cannulation for VA ECMO; he died there 2/8/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/31/2021,22.0,PVT,none,none,none,,none,"['Aphasia', 'Blood creatinine normal', 'Blood fibrinogen increased', 'Blood lactic acid', 'Blood sodium decreased', 'C-reactive protein increased', 'Cardiac arrest', 'Death', 'Diarrhoea', 'Fibrin D dimer increased', 'Multiple organ dysfunction syndrome', 'Myocarditis', 'Oropharyngeal pain', 'Platelet count decreased', 'Pyrexia', 'SARS-CoV-2 antibody test positive', 'Serum ferritin increased', 'Transaminases', 'Troponin increased', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 1044439,KY,36.0,F,"RECEIVED BOTH DOSES OF PFIZER COVID-19 ON 01/27/21 & 02/17/21 REPORTED TO ED ON 02/21/21 WITH COMPLAINTS OF CHEST PAIN AT 25 WKS PREGNANT. DAIGNOSED WITH ACUTE CHEST PAIN, ACUTE PULMONARY EDEMA, AND DYSPNEA ON EXERTION. ADMITTED TO HOSPITAL ON 02/21/21.",Not Reported,,Not Reported,Yes,,Not Reported,,02/17/2021,02/21/2021,4.0,PVT,,,,,,"['Angiogram pulmonary abnormal', 'Chest pain', 'Computerised tomogram thorax', 'Dyspnoea exertional', 'Exposure during pregnancy', 'Pulmonary oedema']",1,PFIZER\BIONTECH,IM 1044451,AZ,69.0,F,Friday feb 12 at 3am her blood dropped and she passed out on the kitchen floor. She upped her insulin as per doctor direction as she read online vaccine can cause blood sugar to change in diabetics. Friday-saturday her blood sugar was up over 200 which is abnormal for her. Sunday her blood sugar came back to normal with her insulin (around 110). She started feel nauseaous and throwing up Sunday-Tuesday. Wednesday /Thursday was having shortness of breath and was sitting outside in the cold to open her airway. Friday 7am my dad heard her breathing funny in the bedroom. she was unconscious but breathing. Breathing stopped and her called 911 and they talked him thru chest compressions. Paramedics came and tried to revive her for 30 min. She passed away at 7:45AM,Yes,02/19/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/12/2021,1.0,PHM,1. lupin ramipril 2. glyburide 3. hydra alazine 4. integra 5. cinacalcet 6. sodium bicarbonate 7. ezetimibe simvastatin 8. allopurinol 9. Humalog insulin 10. tresiba insulin,heart disease kidney disease high blood pressure diabetes,heart disease kidney disease high blood pressure diabetes,,sulpha drug,"['Blood glucose fluctuation', 'Blood glucose increased', 'Breath sounds abnormal', 'Death', 'Dyspnoea', 'Increased insulin requirement', 'Loss of consciousness', 'Nausea', 'Respiratory arrest', 'Resuscitation', 'Vomiting']",1,UNKNOWN MANUFACTURER,SYR 1044459,NY,96.0,F,Grandmother had trouble breathing the night she got the vaccine. She went to the hospital. They found pneumonia and a partial bowel obstruction. The obstruction cleared but she died from the pneumonia on 2/16/21.,Yes,02/16/2021,Not Reported,Yes,9.0,Not Reported,N,02/07/2021,02/07/2021,0.0,PVT,Resperdol lexapro blood pressure med trazodone,None,High blood pressure Dementia Spinal stenosis,,None,"['Death', 'Dyspnoea', 'Intestinal obstruction', 'Pneumonia']",UNK,PFIZER\BIONTECH, 1044460,GA,70.0,M,"About twelve hours after shot (10pm) began to feel uncomfortable. By 10:30pm was shivering with temperature of 101 fahrenheit, headache, sinus congestion with clear liquid running out of nose and nausea. Took two acetaminophen at 11:00 pm. About two hours later, nose stopped running and just had nasal drip. Could not sleep. At 3:30 am (Tuesday morning) nausea subsided. At 10:00 a,m Tuesday still in bed but felt better. Checked temperature and still 101. Continued to take acetaminophen every six hours as recommended. Checked temperature in the afternnon and it was 99. Checked temperature again at 9:00 pm before going to bed and it was exactly 98.6. Decided not to take more acetaminophen. Got up around 3:00 am (Wednesday morning) to use restroom and checked temperature. It was 100.2. Took two acetaminophen and went to bed. That was the last time I registered an elevated temperature. Still feel weak and tired six days later.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/15/2021,02/15/2021,0.0,OTH,"Multiple vitamin, timolol maleate eye drops",None,"Ileostomy and total colectomy 1972, mononucleosis and shingles 1977",,Penicillin,"['Asthenia', 'Body temperature increased', 'Chills', 'Discomfort', 'Fatigue', 'Headache', 'Insomnia', 'Nausea', 'Rhinorrhoea', 'Sinus congestion', 'Upper-airway cough syndrome']",2,PFIZER\BIONTECH,IM 1044463,KY,80.0,F,"RECEIVED 1ST PFIZER COVID19 DOSE ON 02/10/21. ON 02/21/21 REPORTED TO ER COMPLAINING OF SHORTNESS OF BREATH(HX OF AFIB AND DUE TO HAVE CARDIOVERSION SOON). DIAGNOSED WITH ACUTE ON CHRONIC CONGESTIVE HEART FAILURE, ELEVATED TROPONIN, ELEVATED BNP LEVEL, AND LOWER EXTREMEITY EDEMA. ON 02/21/21 ADMITTED AS INPATINET IN HOSPITAL.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/10/2021,02/21/2021,11.0,PVT,,,,,"NEOSPORIN, CIPROFLOXACIN, ANGIOTENSIN RECEPTOR BLOCKERS, ENTRESTO, NYLON, SULFA ANTIBIOTICS, SULFAMETHOXAZOLE-TRIMETHOPRIM, VALSARTAN, AND METOPROLOL.","['Brain natriuretic peptide increased', 'Cardiac failure acute', 'Cardiac failure congestive', 'Dyspnoea', 'Oedema peripheral', 'Troponin increased']",1,PFIZER\BIONTECH,IM 1044480,GA,75.0,M,Patient didn't come to appointment for second dose of Moderna vaccine. Called and spoke with patient's sister in law. Sister in law stated patient was admitted to Hospital positive for COVID-19 on or around 2/5/2021 and was transferred to rehab facility on or around 2/16/2021. She is unsure of when patient's symptoms began. She stated he's doing better and is awaiting negative COVID test to be released from rehab facility. All known information from sister in law,Not Reported,,Not Reported,Yes,12.0,Not Reported,U,01/24/2021,02/05/2021,12.0,PHM,unknown,Unknown,Unknown,,"Patient stated no allergies to any vaccine, vomponent of vaccines, polyethylene glycol and no prescription for epipen","['COVID-19', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1044497,MI,78.0,F,Massive headache for 24 hours following the 2nd dose Mini stroke (TIA),Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/18/2021,02/18/2021,0.0,SEN,"Atorvastatin, Lisinopril, Lodipine Symbacort inhaler",None,High blood pressure High cholesterol,,Penicillin,"['Computerised tomogram', 'Headache', 'Transient ischaemic attack']",2,MODERNA,SYR 1044498,NV,95.0,F,"96 yo F presents with with thrombocytopenia, suspected ITP. Pt had the Pfizer COVID vaccine approx 4 weeks ago. She initially developed an itchy rash on her lower/mid back. Over the last 2 weeks, she also developed increased bruising/purpura on her flank/hip and LEs. Her son, a radiologist, came to town late last week and noted that in addition to bruising, she had what appeared to be petechiae on her LEs. Son had her skip her 2nd dose of vaccine (scheduled for Friday) and took pt to PCP for blood work. CBC apparently showed PLT of 9k so pt went to ER. Repeat PLT was 11k and pt was admitted overnight. She received dex 40 mg IV x 1 on 2/20/21. Repeat PLT today is 11k. Family reports she had normal blood work including CBC about 1 year ago. No active bleeding. No change in mental status No recent viral or bacterial infection. She otherwise feels well. No history of blood disorders or ITP. No history of autoimmune disease.",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/29/2021,02/04/2021,6.0,PVT,"1. Vitamin D3 2000 units p.o. daily. 2. Supplements including calcium, kelp and garlic. 3. Triamcinolone 0.1% cream apply as needed for dermatitis.",None,History of rectal cancer at age 74,,Sulfa,"['Contusion', 'Full blood count', 'Immune thrombocytopenia', 'Petechiae', 'Platelet count decreased', 'Purpura', 'Rash', 'Rash pruritic', 'Thrombocytopenia']",1,PFIZER\BIONTECH,SC 1044500,WA,50.0,F,"2 days after 2nd vaccination, onset of arm, hand numbness and painful rash, bumps in all extremities and under breasts. Also headache and nose bleeding. Then about 1 week out with some improvement of above, onset of photophobia and bilateral eye pain. 2/20/21 ER evaluation also with ophthalmologist found anterior bilateral uveitis Suspect SIRS/hypersensitivity like reaction from vaccine leading to above and placed in observation overnight at hospital. Improved with pred forte1% q 1hr and cyclogyl 1% BID. Testing for other systemic disease sent. Headache and swelling responded to toradol X1. She is recovered and will be followed by EYE clinic as outpt",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/09/2021,02/11/2021,2.0,PVT,"Symbicort MDI, Albuterol MDI, Propranolol 20 PO BID",,Asthma Obese BMI 37 essential tremor,,Bee sting causes anaphylaxis Zonisamide causes excess sedation Bupropion causes seizures,"['C-reactive protein increased', 'Epistaxis', 'Eye pain', 'Headache', 'Hypersensitivity', 'Hypoaesthesia', 'Iridocyclitis', 'Photophobia', 'Rash', 'Red blood cell sedimentation rate increased', 'Slit-lamp tests abnormal', 'Swelling', 'Systemic inflammatory response syndrome', 'White blood cell count increased']",2,MODERNA,IM 1044502,WA,65.0,F,"1 hour post vaccine: drunken state, headache 24-48 hours post vaccine: headache, fever 120 hours post vaccine: unresponsive and altered mental state",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/15/2021,02/15/2021,0.0,PVT,"Escitalopram 20 mg daily, Levothyroxine 100 mcg daily, Oxybutynin ER 5 mg daily, Lorazepam 0.25-0.5 mg at bedtime PRN sleep, Vitamin D3 1000 units daily, Oxycodone 5-20 mg every 3 hours PRN pain",None,"Hypothyroidism, Depression",,No known drug allergies.,"['Computerised tomogram head', 'Computerised tomogram thorax', 'Feeling drunk', 'Headache', 'Magnetic resonance imaging brain', 'Mental status changes', 'Pyrexia', 'Toxicologic test abnormal', 'Unresponsive to stimuli']",2,MODERNA,IM 1044555,CA,78.0,M,Pt had 2nd dose on 2/18. Had fall on 2/19 from weakness resulting in rhabdomyolysis.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/18/2021,02/19/2021,1.0,PVT,"atenolol, prinzide, Lipitor, Vitamin B12, aspirin",None,"HTN, HLD, DM2, CKD, hx of stroke",,NKDA,"['Asthenia', 'Blood creatine phosphokinase', 'Fall', 'Rhabdomyolysis', 'Troponin']",UNK,PFIZER\BIONTECH, 1044569,WI,85.0,M,THROMBOTIC STROKE IN THE DISTRIBUTION OF THE LEFT MCA DISTRIBUTION,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/17/2021,02/20/2021,3.0,PVT,": FISH OIL 900MG ORAL , Ref: 0 Instructions: Take 1200MG TWICE DAILY. Rx: VITAMIN D3 1000iu ORAL , Ref: 0 Instructions: Take ORAL DAILY. Rx: furosemide 20 mg tablet Ref: 2 Instructions: Take 1 Tablet Oral",acute inflammatory arthritis elbow.,"Venous insufficiency Senile cataract Arm melanoma NEVER SMOKER Obesity Stroke Carpal tunnel syndrome Osteoarthritis of hand Prediabetes Diverticulitis CONG HEART FAIL COMB, CHRON Iron deficiency anemia due to chronic blood loss Benign prostatic hypertrophy w/ urinary obstr ... Cervical degenerative disc disease SKIN CANCER SCALP Osteoarthritis of knee Atrial fibrillation Benign essential hypertension Mixed hyperlipidemia Benign prostatic hypertrophy without urinary ... Albuminuria Stage 3 Obstructive sleep apnea Reflux esophagitis Cerebral atherosclerosis Long-term (current) use of anticoagulants Former smoker Hypothyroidism Major depressive disorder, single episode, mi ... Albuminuria Stage 2 Actinic keratosis Lumbar radiculopathy Inflammatory arthritis Polymyalgia rheumatica Long term use of systemic steroid Seronegative rheumatoid arthritis Anemia, unspecified Osteoarthritis of shoulder Cervical radiculopathy Pseudogout",ACUTE INFLAMMATORY ARTHRITS FOLLOWING FIRST PFIZER,amoxiccillin and atorvastatin,"['Cerebral artery thrombosis', 'Cerebrovascular accident', 'International normalised ratio increased', 'Magnetic resonance imaging brain abnormal', 'Thrombotic stroke']",4,PFIZER\BIONTECH,IM 1044581,CA,71.0,F,"71 year old female with a past medical history of colon cancer status post colectomy and chemotherapy completed 01/07/2021, hypertension, no previous history of allergic or anaphylactic reactions who presents to the ED to be evaluated for pruritic rash x 8 weeks, upper lip swelling and throat tightness since last night, possible reaction to Covid vaccine. She received her first COVID vaccine on 01/19/21 about 10 days later she developed a pruritic rash to her trunk and legs. Spoke with her Heme-Onc team who advised her to take Claritin and benadryl with partial relief of rash. �On 01/30/2021 patient had a virtual visit with the doctor who prescribed a 5-day course of prednisone, as soon as she completed the course pruritic rash returned. �Patient was advised to go ahead with the second dose of the vaccine which she received on 02/16. �She presents to the emergency room today because last night began to feel as though her throat was closing and began to have swelling in her upper lip. �Patient presents today with upper lip angioedema, no troubles breathing. Denies fever, chills, headache, chest pain, shortness of breath, abdominal pain, nausea, vomiting, dysuria, change in urine or bowels. Patient cannot think of any provoking factors. �Denies new soaps, lotions, home gardening, outdoor hobbies. �States she has been quarantining at home with her husband who does not have any symptoms.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/19/2021,01/28/2021,9.0,PVT,"gabapentin, amlodipine, lisinopril",Colon cancer,,,NKDA,"['Angioedema', 'Lip swelling', 'Rash', 'Rash pruritic', 'Throat tightness']",UNK,MODERNA,IM 1044610,GA,78.0,M,"Nausea, vomiting, dizziness, distorted vision, sore arm, fever, injection site swelling, ambulatory deficiency. Admitted to Hospital",Not Reported,,Yes,Yes,4.0,Yes,N,01/29/2021,02/04/2021,6.0,PVT,"Lisinopril, Metformin, Levothyroxine, Warfarin NA, Amlodipine Besylate, Natures Bounty Super B-Complex",None,"High blood pressure, Type 2 Diabetes, Glaucoma, Blood Clots, thyroid insuffiency",,Darvon,"['Cerebrovascular accident', 'Computerised tomogram', 'Dizziness', 'Electrocardiogram', 'Gait disturbance', 'Injection site swelling', 'Laboratory test', 'Magnetic resonance imaging', 'Metamorphopsia', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 1044664,CA,78.0,F,"was given maternal vaccine, developed acute heart failure, and NSTEMI then next day",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/20/2021,02/20/2021,0.0,PVT,unknown,unknown,"She has listed history of coronary artery disease, hypertension, paroxysmal atrial fibrillation on Coumadin anticoagulation therapy, obesity with BMI greater than 35.",,"statin, HcTz, sulfa","['Acute myocardial infarction', 'Cardiac failure acute', 'Troponin increased']",UNK,MODERNA, 1044670,CO,89.0,F,"Patient received second vaccine dose and felt well without significant symptoms in the days following. Then, on 2/19 she developed epistaxis, brusining, and petechiae. She had labs drawn by a local provider and platelet count was 7. (baseline, even on chemotherapy for her AML is in the normal range). Therefore, she reported to a local health center and a recheck of the platelet count was <3k. WBC and Hb were within normal range. No circulating blasts or other evidence of AML. No recent infections or other exposures. That center reached out for transfer to our hospital as we initially diagnosed and treated her AML. I advised dexamethasone 40mg and transfer (they also transfused 5u platelets prior to her departure) Upon arrival at our center about 12hrs later, platelet count was 210 and on 2 rechecks it has remained in the normal range while continuing dexamethasone 40mg daily. Bleeding symptoms ceased and she was discharged in stable condition. She plans to return back to home after discharge with repeat lab testing later this week after stopping steroids. Chemotherapy to be held at least one extra week to ensure stability.",Not Reported,,Yes,Yes,2.0,Not Reported,Y,02/11/2021,02/19/2021,8.0,PVT,"Eliquis 2.5 mg oral tablet: 2.5 mg, 1 tab, Oral, BID, 60 tab, 0 Refill(s) LORazepam: 0 Refill(s) Metoprolol Tartrate 25 mg oral tablet: 12.5 mg, 0.5 tab, Oral, BID, 0 Refill(s) Zofran: 0 Refill(s) acyclovir: 0 Refill(s) albuterol HFA 90 mcg",Acute myeloid leukemia - in remission x 24 months,AML Atrial fibrillation HTN Hypothyroidism Follicular lymphoma - currently no evidence of disease Melanoma - in remission,,"Fish, Erythromycin, flecainide, ibuprofen, penicillin","['Computerised tomogram head normal', 'Contusion', 'Culture urine negative', 'Epistaxis', 'Full blood count', 'Haemoglobin normal', 'Influenza virus test negative', 'Metabolic function test', 'Metabolic function test normal', 'Petechiae', 'Platelet count decreased', 'Platelet transfusion', 'SARS-CoV-2 test negative', 'Urine analysis normal', 'White blood cell count normal']",2,PFIZER\BIONTECH,IM 1044676,IL,56.0,F,"Fever, Severe chills, Muscle weakness and aches, lethargy, metallic taste, loss of appetite, nausea, vomiting",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/01/2021,02/01/2021,0.0,UNK,"Vitamin C, Evening Primrose Oil, Vitamin D, Calcium supplement",None,None,,None,"['Chills', 'Decreased appetite', 'Dysgeusia', 'Lethargy', 'Muscular weakness', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 1044692,MN,89.0,M,Right hemisphere stroke. Currently hospitalized. Stable condition.,Not Reported,,Not Reported,Yes,5.0,Yes,U,02/17/2021,02/18/2021,1.0,SEN,Synthroid,,,,,['Cerebrovascular accident'],UNK,MODERNA, 1044704,WV,69.0,M,"Light headedness, fatigue, nausea",Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,PHM,,None,"High blood pressure, COPD",,None,"['Dizziness', 'Fatigue', 'Nausea']",UNK,PFIZER\BIONTECH, 1044716,CA,77.0,M,"On the fourth day after receiving the first dose of Moderna Covid 19, I started experiencing abdominal which doctors determined was appendicitis. I had laparoscopic surgery for it. Don't know if there is any causal effect between the vaccine and my developing appendicitis. Info online says Pfizer, not so much Moderna, more than double the number of clinical development volunteers developed appendicitis than did those that took the placebo. Am just reporting; don't know if there is a causal effect.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/25/2021,01/29/2021,4.0,PHM,"Pradaxa, thyroid medicine",none,none,,None,"['Appendicitis', 'Gastrointestinal disorder', 'Laparoscopic surgery']",1,MODERNA,SYR 1044726,KY,86.0,F,RECEIVED 1ST DOSE OF PFIZER COVID-19 VACCINE ON 02/07/2021. ON 02/20/21 WENT TO URGENT CARE WITH COMPLAINTS OF LOWER BACK PAIN AND LOWER ABDOMINAL PAIN X4 DAYS. DIAGNOSED ACUTE RIGHT FLANK PAIN AND RUQ ABDOMAINL PAIN. SENT TO ER FOR IMMEDIATE EVALUATION. ON 02/20/21 WENT TO ER FOR RUQ ABDOMINLA PAIN THAT RADIATE STO RIGHT FLANK. DIAGNOSED WITH BILARY COLIC AND CALCULUS OF GALLBLADDER WITH OUT CHOLECYSTITIS WITHOUT OBSTRUCTION. ON 02/20/21 ADMITTED INPATIENT TO HOSPITAL.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/07/2021,02/20/2021,13.0,PVT,,,,,"INVOKANA, CODEINE, GLIPIZIDE, JANUVIA (SITAGLIPTIN), MELOXICAM, NIACIN AND RELATED, AND SULFA ANTIBIOTICS","['Abdominal pain lower', 'Abdominal pain upper', 'Back pain', 'Biliary colic', 'Cholelithiasis', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram pelvis', 'Diverticulum', 'Flank pain', 'Pain', 'Pulmonary mass', 'Scan with contrast abnormal', 'Ultrasound biliary tract']",1,PFIZER\BIONTECH,IM 1044756,NY,32.0,F,I received my first dose of the COVID19 Pfizer vaccine on 12/30/20. At this point I was 4 weeks pregnant. I received my second vaccine dose for the series on 1/22/21. At this point I was 7 weeks pregnant. On 2/18/21 I was diagnosed with a miscarriage due to no fetal heartbeat on ultrasound. I now have to undergo a D&C in the operating room.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,02/18/2021,27.0,PVT,synthroid prenatal vitamin calcium supplement,none,hypothyroid,,none,"['Abortion spontaneous', 'Exposure during pregnancy', 'Foetal heart rate abnormal', 'Ultrasound foetal abnormal']",2,PFIZER\BIONTECH,IM 1044760,WA,67.0,M,2 weeks after vaccination (2/20/2021) I lost movement of right side of mouth and right eye. Went to ER to check for possible stroke.,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/06/2021,02/20/2021,14.0,PVT,"magnesium, iron, omeprazole, metformin hydrochloride, metropolol succinate, amlodapine besylate/valsartin, clopidogrel, rosuvastatin calcium",none,high blood pressure,,none,"['Computerised tomogram', 'Electrocardiogram', 'Facial paralysis', 'Magnetic resonance imaging']",1,PFIZER\BIONTECH,IM 1044780,WI,73.0,M,SEPTIC SHOCK ACUTE LIVER INJURY ENCEPHALOPATHIC PRESENTED WITH BLOODY DIARRHEA. TRANSAMINASES IN THE 1000S. IN SEPTIC SHOCK. INTUBATED AT PRESENT,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/18/2021,02/19/2021,1.0,PVT,"P1 Current Medications: Rx: INSULIN SYRINGE/NEEDLE 28G X 1/2""0.5 ML N/A Each, Ref: 11 Instructions: Take inject Each N/A AT BEDTIME. for use with Lantus 15u qhs. dx: 250.62 Rx: GLUCOSAMINE 1500MG ORAL Capsule, Ref: 0 Inst",NONE,"Ulnar neuropathy (ICD10 = G56.20 / ICD9 = 354.2 / SNOMED = 367399005) Former smoker (ICD10 = Z87.891 / ICD9 = V15.82 / SNOMED = 8517006) Diabetes mellitus with neurological manifesta ... (ICD10 = E11.40 / ICD9 = 250.62 / SNOMED = 421326000) Mixed hyperlipidemia (ICD10 = E78.2 / ICD9 = 272.2 / SNOMED = 267434003) Cervical root neuropathy (ICD10 = M54.12 / ICD9 = 723.4 / SNOMED = 54404000) Chronic lymphocytic leukemia (ICD10 = C91.90 / ICD9 = 204.10 / SNOMED = 92814006) Low back pain (ICD10 = M54.5 / ICD9 = 724.2 / SNOMED = 279039007) Peripheral vascular disease (ICD10 = I73.9 / ICD9 = 443.9 / SNOMED = 400047006) Chronic kidney disease, Stage III (moderate) (ICD10 = N18.30 / ICD9 = 585.3 / SNOMED = 433144002) Chronic lymphoid leukemia (ICD10 = C91.90 / ICD9 = 204.10 / SNOMED = 92814006) Albuminuria (ICD10 = R80.9 / ICD9 = 791.0 / SNOMED = 274769005) Type 2 diabetes with diabetic gastroparesis (ICD10 = E11.43 / ICD9 = 536.3 / SNOMED = 423263001) Diabetes mellitus Type 2 with neurologic comp ... (ICD10 = E11.40 / ICD9 = 250.62 / SNOMED = 421326000) Chronic alcoholism in remission (ICD10 = F10.21 / ICD9 = 303.93 / SNOMED = 191813001) Benign essential hypertension (ICD10 = I10 / ICD9 = 401.1 / SNOMED = 1201005) Diabetes mellitus Type 2 w/ peripheral vascul ... (ICD10 = E11.51 / ICD9 = 250.72 / SNOMED = 422166005)",,NONE,"['AST/ALT ratio abnormal', 'Blood lactic acid increased', 'Diarrhoea haemorrhagic', 'Encephalopathy', 'Endotracheal intubation', 'Hypotension', 'Liver injury', 'Septic shock']",3,PFIZER\BIONTECH,IM 1044794,,91.0,F,acute hypoxic respiratory failure,Not Reported,,Yes,Yes,,Not Reported,U,01/01/2021,02/01/2021,31.0,PVT,,,,,,"['Acute respiratory failure', 'Respiratory failure']",UNK,MODERNA, 1044825,RI,71.0,M,Sudden cardiac arrest ~24 hours after first vaccination dose. Patient on ventilator.,Not Reported,,Yes,Yes,,Yes,N,02/19/2021,02/20/2021,1.0,OTH,"Tamsulosin HLg 0.4 mg (1 a day), Fosinopril sodium 20 mg 1 1/2 a day, 81 mg aspirin 1 day",Inflammation blood work HCRSP 10 x normal value was in process of ruling out rheumatoid arthritis.,Medtronic pacemaker 1 year. TIA January 2020,,Penicillin and sulfa,"['Cardiac arrest', 'Mechanical ventilation']",1,PFIZER\BIONTECH,SYR 1044885,OR,72.0,F,"On 2/2/21 I developed chest pressure and irregular heart beat at 4:00 pm. Went to ER and it spontaneously resolved while staff was telling me how they would treat it. Gave me Metoprolol 5 mg IV with 500 IV fluids and discharged. Then on 2/6/21 I slept poorly and felt very jittery and had more chest pressure but pulse was regular. then on 2/8/21 at 6:00 am I awoke and felt terrible with chest pressure. Took my blood pressure at home and it was 193/103, and I was very shaky. Went to ER where they did blood work, X-ray, and monitored my heart and blood pressure for 4 hrs. Gradually my blood pressure came down, and my blood work and X-ray probed to be WNL. I was discharged without medication change but had echocardiogram scheduled and follow-up appt. with Cardiologist, on zoom. He started me on Flecainide 100 mg bid, and stress test on 2/24/21 and follow-up appt. with him on 3/3/21. I also had a follow-up appt. with my GP the day after the first ER visit and she ordered more labs, and the echocardiogram. I have continued to have feelings of fluttering and pressure in my chest off and on and they continued after my second vaccine. But my heart has remained regular since starting the Flecainide. But my blood pressure went up to 150/85 on 2/9/21 and again to 142/81 on 2/10/21 both times with feelings of jitteriness and pressure in my chest.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/24/2021,02/02/2021,9.0,PVT,"Amlodipine, Atenolol, Crestor, ASA, Cal, Mg, and Zinc, Fish oil, and Multi vit.",None,"HTN, high cholesterol, arthritis,",hepatitis B developed transient arthritis. Never completed the series.,Epinephrine,"['Blood pressure increased', 'Blood test normal', 'Cardiac flutter', 'Chest discomfort', 'Feeling jittery', 'Heart rate irregular', 'Malaise', 'Nervousness', 'Poor quality sleep', 'X-ray normal']",UNK,PFIZER\BIONTECH,IM 1045127,FL,32.0,F,"Fevers with temperatures up to 102.7, chills, and headaches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,None,None,None,,"Sulfa, vancomycin","['Body temperature increased', 'Chills', 'Headache', 'Pyrexia']",UNK,MODERNA,IM 1045128,MA,81.0,F,"large red patch 3-4 inches below the injection site, red, slightly itchy; first patch 2 days later is starting to fade but a 2nd patch formed 2 days later, smaller 1 inch below the first patch; first patch is fading to very light pink; both patches are both pink",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/19/2021,2.0,OTH,"sertraline,, 2000 units Vitamin D, Losartan, hydrochlorothiazide, atenolol",Covid 19 4 weeks prior,"hip replacement, arthritis, high blood pressure,",tetanus,"Bactrim, Amoxicillin, Tetanus, Acyclovir","['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 1045129,NJ,105.0,F,"On 02/16/2021 at approximately 6 PM, patient, who usually uses a walker, fell while returning to her chair. Although she reports that she is not in any pain, since then she has been unable to walk more than 1-2 steps. She has also lost her appetite.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/16/2021,6.0,OTH,metoprolol; levothyroxine; fish oil; multivitamin.,None.,,,aspirin.,"['Decreased appetite', 'Fall', 'Gait inability']",UNK,MODERNA,IM 1045132,ID,52.0,F,"1st dose just a sore arm 2nd dose pain, swelling and redness at injection site. I have approximately a 2 1/2? x 2 1/2? red raised welt also very warm. I couldn?t raise my arm very high because of the pain This started about 24-36 hours after injection Fever chills body aches fatigue nausea no appetite about 36 hours after injection. Those side effects lasted about 24 hours. Still have the pain redness and swelling in my arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,WRK,Multivitamin Zinc Calicum,None,None,,None,"['Chills', 'Decreased appetite', 'Fatigue', 'Injection site erythema', 'Injection site joint movement impairment', 'Injection site pain', 'Injection site swelling', 'Injection site urticaria', 'Injection site warmth', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,IM 1045133,NE,74.0,F,shortly after receiving vaccine patient began to feel itchy. patient had urticaria to neck and shoulders as well as the injection site. patient also states she felt like she had a really dry throat. patient taken to ED for further evaluation and treatment,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,PUB,,,,,,"['Dry throat', 'Injection site urticaria', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 1045134,FL,72.0,F,"Swelling in right arm near the injection site about 3?X 3?, chills, headache, extremely tired, congested, fatigued ,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,PVT,"Levothyroxine, metoprolol, lavola, lisinopril",Hashimoto?s disease,"Hashimoto?s Disease, high cholesterol, remission breast cancer",,"Latex, nickel","['Fatigue', 'Headache', 'Injection site swelling', 'Nasal congestion']",UNK,MODERNA,SC 1045135,MI,71.0,F,"Temp 101, Aches, Shivering and Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,OTH,"Synthroid, Dephenpoxylate/Atropean, Budesonide, Vit D, Vit B12",None,Microscopic colits,,"Latex, Shrip","['Body temperature increased', 'Chills', 'Pain']",2,PFIZER\BIONTECH,IM 1045137,,80.0,F,"Rash on arm, red, pain on arm",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/21/2021,1.0,UNK,Blood pressure Vitamins,,Diabetes type 2,,Penicilin,"['Erythema', 'Pain in extremity', 'Rash']",2,MODERNA,SYR 1045138,CA,36.0,F,15 hours after injection I experienced severe joint pain all over my body. This continued until 32 hours post vaccine. Motrin and Tylenol helped but didn?t completely take all pain away. Injection arm was slightly sore. I was lethargic until 36 hours post vaccine. All symptoms subsided the next morning.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,MIL,Flonase,None,None,,"Erythromycin, sulfa drugs","['Arthralgia', 'Injection site pain', 'Lethargy']",2,PFIZER\BIONTECH,SYR 1045139,AZ,34.0,F,"Low grade fever, headache, painful lump at injection site, redness at injection site, pain in arm that feels like its to the bone.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,PVT,None,None,None,,None,"['Headache', 'Injection site erythema', 'Injection site mass', 'Injection site pain', 'Pyrexia']",1,MODERNA,SYR 1045140,OR,53.0,F,"About a day after the 1st vaccine, I got a rash on my face that felt like sandpaper. My face was became more swollen after four days and finally started decreasing in swelling after the 5th day. My eyelids were the most noticeable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/03/2021,1.0,PUB,gabipentan,,,,gluten (celiac disease),"['Rash', 'Skin texture abnormal', 'Swelling face', 'Swelling of eyelid']",1,MODERNA,SYR 1045141,IL,43.0,F,"Symptoms began approximately 12 hours after receiving shot- chills, body aches, loss of appetite. After sleeping from 12am until 11am the next morning, I awoke with fever and extreme exhaustion. I was unable to get out of bed or stay awake until 5pm, an hour after taking Tylenol. I also experienced. brain fog for several days after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/13/2021,1.0,PVT,Probiotics,,,,Penicillin,"['Bedridden', 'Chills', 'Decreased appetite', 'Fatigue', 'Feeling abnormal', 'Pain', 'Pyrexia', 'Somnolence']",2,MODERNA,SYR 1045144,CO,32.0,M,"I had sore arm, chills, fatigue and dizziness for 2 days. All other symptoms subsided but the dizziness has persisted.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,PVT,"Tylenol, Ibuprofen, meclizine, dimenhydrinate, Ativan",None,None,,None,"['Blood thyroid stimulating hormone', 'Chills', 'Computerised tomogram head', 'Dizziness', 'Electrocardiogram', 'Fatigue', 'Full blood count', 'Metabolic function test', 'Pain in extremity']",2,MODERNA,IM 1045145,NJ,79.0,F,"Immediately nose started running, backdrip, hoarseness. After I left with my daughter, cough, mucous in chest, hoarseness, heaviness in chest, tickle in chest Have been on Benadryl and Nasacort since. Today is the 6 th day and I still need Benadryl every four hours Need a spray for chest. Have used albuterol. Tomorrow I will speak to the doctor",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/16/2021,0.0,PVT,None,None,Gastritis Osteoporosis Arthritis,,Several antibiotics Summer fruit Pineapple,"['Chest discomfort', 'Cough', 'Dysphonia', 'Immediate post-injection reaction', 'Rhinorrhoea', 'Secretion discharge', 'Upper-airway cough syndrome']",1,MODERNA,SYR 1045146,CA,58.0,F,None,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/20/2021,0.0,WRK,Nine,None,None,,None,['Unevaluable event'],1,PFIZER\BIONTECH,SYR 1045147,FL,72.0,F,"Swollen arm, muscle and joint aches, chills, elevated temp for 24-36 hours, temp between 100.6 and 101.8, diarrhea, exhaustion.. treated with Tylenol and water consumption",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,PUB,"Multivitamin, Calcium, Fish Oil, Baby Aspirin, Glucosamine, B12",None,No,,No,"['Arthralgia', 'Body temperature increased', 'Chills', 'Diarrhoea', 'Fatigue', 'Myalgia', 'Peripheral swelling']",2,MODERNA,IM 1045149,TX,67.0,F,"I received the 2nd Covid injection. I went to the 15-minute waiting area. The waiting area was full, so my husband and I were standing. I stand and work every day, so this was not difficult. I texted my daughter, who is a hospital employee, and told her that we had a super experience with no wait and had already received our 2nd dose. However, 5 to 7 minutes after the injection, I SUDDENLY felt dizzy and weak and had to sit down. Within a minute or so, I could not stand or open my eyes. The weakness made it difficult to breath or talk. My husband had to lift me up into a wheelchair. I was taken to the ER. For the longest time, I could not even open my eyes or talk above a whisper. After 4 hours, I was able to get my eyes open and talk better. I, gradually, was able to move my hands and feet. Last of all, I could move my hips and walk. It was as if my body had been put to sleep. I could feel everything but my body wouldn?t move. As it wore off, my face and limbs felt slightly tingly. I was, basically, fine after 5 hours other than being tired from the experience. The doctors had no explanation for what happened and said it must be an emotional response to getting the shot. They wrote that I was not exerting enough effort to move my body. One said that I was hyperventilating when I pulled my mask up to breathe after he told me to hold my leg in the air. Though I tried, I was too weak to hold my leg up and it fell to the bed. The doctor told me that I should not tell anyone about what had happened or people would not come to get the Covid vaccination. He obviously knew that SOMETHING had happened that I couldn't control but he didn't put that in his report!",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,"NP Thyroid Tablets 45Mg Prometrium Capsules 100 mg Estradiol Transdermal System, USP (Twice Weekly) .0375 mg/day Vitamin D3 3000IU",cough due to allergies,easily startled,,Septocaine with epinephrine Caused my throat to swell up and I had difficulty breathing.,"['Aphasia', 'Asthenia', 'Blood glucose normal', 'Differential white blood cell count normal', 'Dizziness', 'Dyspnoea', 'Dysstasia', 'Electrocardiogram normal', 'Eyelid function disorder', 'Fatigue', 'Full blood count normal', 'Gait disturbance', 'Hyperventilation', 'Metabolic function test normal', 'Mobility decreased', 'Paraesthesia', 'Troponin T normal']",2,PFIZER\BIONTECH,SYR 1045150,SD,59.0,M,Patient found in home deceased.,Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/20/2021,10.0,PVT,Lisinopril Levetiracetam,Unknown,Dyslipidemia Hypertension Seizure Disorder,,NKDA,['Death'],1,PFIZER\BIONTECH,IM 1045151,CA,30.0,F,"Heartbeat racing five minutes after shot (but stopped before the 15 minute waiting period at clinic) Woke up next day around 9am and felt like I had a fever and chills, but checking temperature verified I did not. I also had a sore left arm, a headache, body aches, and some fatigue (general grogginess). I went to work that day and woke up the next day feeling fine again.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PUB,"Daily vitamins (vitamin d, calcium, iron, b12, zinc)",None,None,"Similar side effects for other vaccines, but a little worse this time","None known (also lifelong vegetarian, now vegan if that?s relevant)","['Chills', 'Fatigue', 'Feeling of body temperature change', 'Headache', 'Heart rate increased', 'Pain', 'Pain in extremity', 'Somnolence']",1,MODERNA,SYR 1045152,CO,61.0,F,"Swollen red rash below injection site, red and warm to the touch",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,OTH,Valsarten 160mg Nortriptyline 25mg Vitamin D-3 5000 IU Bayer Asa 81mg Magnesium 400mg,1/6 - root canal treated with amoxicillin 1/24 - urinary tract infection treated with Cipro,Hypertension controlled with medication,,"PCN, Naproxen","['Injection site erythema', 'Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Rash erythematous']",2,MODERNA,IM 1045154,CA,39.0,M,"Pt reports ""white coat syndrome"" and ""panic attacks"" related to injections. Also reports feeling dizzy and appears anxious. 11:29 BP 167/102, P. 109 R. 21 Temp. 97.0 Spo2:96% 11:35 BP 164/101, P.96, Temp 97.5 Spo2:97% 11:50 BP 176/101 P.92 R. 20 Temp 97.6 Spo2:98% Pt laid on the floor with eyes closed and feet elevated. Instructed to used deep breathing techniques. Provided Benadryl 25mg PO as directed by MD standing orders. Patient was observed and left vaccination clinic after panic attack. Pt denied any symptoms and/or distress.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/18/2021,0.0,OTH,,"Patient reports history of ""white coat syndrome"" and ""panic attacks""",HIV,,,"['Anxiety', 'Dizziness']",UNK,PFIZER\BIONTECH,IM 1045155,WA,65.0,F,"headache, muscle/joint pain, fatigu�, temperature, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,OTH,none,none,none,,pennicillin,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Nausea']",2,MODERNA,IM 1045156,TX,40.0,F,raised itchy hard quarter sized bump at vaccination site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/19/2021,8.0,UNK,,,obese,,,"['Vaccination site induration', 'Vaccination site pruritus', 'Vaccination site swelling']",1,MODERNA,SYR 1045157,CO,35.0,F,"Large hot, red, painful bump.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/20/2021,1.0,PVT,"Yaz birth control. Prilosec, flovent",No,No,,"Gluten sensitive, sulfa drug allergy","['Erythema', 'Pain', 'Skin warm', 'Swelling']",1,MODERNA,SYR 1045158,TX,61.0,F,"2/10/21: Woke up with chills, no fever @5:15am, back to sleep, Temp 99.3F at 10:05am, Tylenol at 10:50am, Temp 100.3F at 5:15pm Temp 101.3F at 9:10pm and took tylenol and regular medications, Temp 100.6F at 10:55pm and went to sleep. 2/11/21: woke up with temp 98.7 at 10:00am, had body aches, red and feverish area where vaccine was given in upper left arm. The red, itchy and feverish area about 3 inches x 2 inches on upper left arm lasted about 5 days, also got a lump under left arm that lasted about 6 days and all of these went away by 2/17/21. But I've had more fatigue, and shortness of breath since this 2nd vaccine. Misses my doctor appointment on 2.17/21 due to the winter storm, not going anywhere , we were having all last week.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,02/10/2021,1.0,PUB,"Tramadol 50mg,Cyclobenzaprine 5mg, Atorvastatin 40mg, Famotidine 20mg, Zytrec, Flonase Spray, Tylenol 650mg, Metformin 500mg, Gemfibrozil 600mg, Esomeprazol 40mg DR ,Detrol LA 2mg, Asprin EC 81mg, Lisinopril-HCTZ 10-12.5mg, Montelukast 10m","Diabetes 2, High Blood Pressure, Asthma, GERD, History of ulcers and colon polyps, Gastroparesis, Stage III Chronic Kidney Disease, Spinal Stenosis, herniated disc, Neuropathy, previous stroke and mini strokes",See above,,"Mobic, Gabapentin, Lyrica, Mold, Dust, Cedar, Hay","['Body temperature increased', 'Chills', 'Dyspnoea', 'Fatigue', 'Injection site erythema', 'Injection site mass', 'Injection site pruritus', 'Injection site warmth', 'Pain']",2,PFIZER\BIONTECH,IM 1045159,IL,54.0,F,"Fever 104.0, painful swelling of lymph nodes in neck and under both arms and in chest",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,PUB,None,None,None,,Too many to list,"['Lymphadenopathy', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 1045160,,65.0,M,"Continuing redness - rash - just below the vaccine site; at this point, 19 days after the 1st dose",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,PUB,None,,Hashimoto's,,,"['Injection site erythema', 'Injection site rash']",UNK,MODERNA, 1045162,NM,36.0,F,"?COVID arm? delayed cutaneous hypersensitivity; Firmness day 1-2, a lot more painful than initial injection pain, redness that increased/spread over 3 days, painful to touch, slightly raised and swollen, started really painful ? itchy days 2-5. Took photos.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/12/2021,7.0,PUB,"Topiramate, Bupropion, Montelucast, amitripytiline, omeprezole, lamotrezine, norethindone",No,"Barrett?s, endometriosis, depression, seasonal allergies,",,None,"['Dermatitis allergic', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SC 1045164,NV,25.0,M,"The morning after I received both vaccine shots, I posted hearing from my right ear. The first time I received the vaccine shot, the morning after, I could barely hear out of my right ear. It almost sounded like there was a clog or earwax build-up. I didn't really think much of it and it gradually went away several days later. The worst day was the next day after the vaccine and it lasted, even though in a small amount, until 3 days after. The second dose caused the same problem. The morning after the second dose of the vaccine, I lost my hearing in the same way as before. I could barely hear out of my ear, however, I was also exhausted and ended up sleeping most of the day. When I woke up in the afternoon, I couldn't hear from my right ear, but I could hear better. (maybe 25% back to normal). The two days after the vaccine, my hearing came back way better than the previous time. It felt like 80% back to normal and later in the today, it felt like it up to 95% back to normal. The best way I can describe the feeling was as if the sound was still being received to my hear, but it sounded muffled and turned down. I was still able to hear the deeper sounds during conversations and deeper 'beats' in music, but the sharpness of everything was turned off.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,WRK,None,None,None,,None,"['Fatigue', 'Hypoacusis']",1,MODERNA,SYR 1045165,LA,42.0,M,"Severe Anaphylaxis onset at 3:00am. Epinephrine administered at home. Transported to ER. BP 80/40 at admission. 2nd Epinephrine administered at ER. IV fluids. BP recovered and discharged at 7:30am. Prescribed Prednisone 20mg, Famotidine 20mg, and Cetirizine 10mg.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/28/2021,01/29/2021,1.0,PVT,Amlodipine 5mg 1/day Losartan 50mg 1/day Adderall 20mg 1/day Ibuprofen,None,Hypertension,,None known,"['Allergy test', 'Anaphylactic reaction', 'Reaction to preservatives']",UNK,PFIZER\BIONTECH, 1045166,AK,49.0,F,"Itchy rash near the injection site appeared 2/21/21. 2 1/2 inches long, 2 inches wide. There is still a faint pink border as to where the edges of the bandaid were (noted on the V-safe site of redness where bandaid was - no pain or itchiness symptoms at that time). The upper part of the rash touches the lower part of the pink bandaid outline. Bandaid outline still has no pain or itchiness. This symptom did not occur until after all the V-safe checking were complete. I have taken a Claritin and put anti itch cream on the site. At this point I do not have enough concern to notify a doctor. I will contact Teledoc if the rash spreads further or adversely changes in any other ways.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PHM,"Women?s 1aday, magnesium, B12, C, D, Claritin",,,,"Dander allergies, possible hay and other outside allergens (minor).","['Injection site erythema', 'Injection site reaction', 'Rash pruritic']",1,MODERNA, 1045167,TX,24.0,M,"Pain in arm spreading throughout first few hours, by 14 hours post vaccination hives began appearing with increased intensity and number. By 15 hours post vaccination a mild headache and low fever of 100.8 developed. Treatment included diphenhydramine to ease antihistamine response and aspirin to lower fever and reduce severity of headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/22/2021,1.0,UNK,Diphenhydramine,,,,,"['Headache', 'Pain in extremity', 'Pyrexia', 'Urticaria']",2,MODERNA,IM 1045169,AZ,76.0,M,"Developed quite a bit of pain in the tip of left index finger. Also, have slight numbness feeling there.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/19/2021,14.0,OTH,,Heart,Heart,,None,"['Hypoaesthesia', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 1045170,WA,70.0,F,"Fever,chills,upset stomach, body aches,headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PVT,"Omeprazole, buspar, estrovan,multivitamin",None,N/a,Pfizer shot 1- same symptoms,Prozac,"['Abdominal discomfort', 'Chills', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1045171,AZ,44.0,F,"Day 1 - pain in arm where shot was administered. Day 2 - 4 - pain down arm concentrated in left arm-pit, area surrounding arm-pit and left wrist and top of hand.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,OTH,"Vitamin D, Vitamin C, multivitamin, welbutrin, pravastatin",none,wolff-parkinson-white,CoVid-19 Pfizer shot 1 on 1/25/2021 had swelling/numbness of throat within minutes. EMT gave benedryl. cleared up within 24 ho,none,"['Arthralgia', 'Axillary pain', 'Injection site pain', 'Pain in extremity']",2,PFIZER\BIONTECH,SYR 1045172,FL,50.0,F,"There were things that I expected, like the muscle aches, fatigue, fever. But I didn?t know I was going to get such heart palpitations. I got the shot Friday afternoon, I started noticing the palpitations Saturday afternoon, and now Sunday night they?re really bothering me. They?re almost continuous. It feels like I drank a lot of caffeine, but I haven?t.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,OTH,,None,Asthma,,Penicillin,"['Fatigue', 'Myalgia', 'Palpitations', 'Pyrexia']",UNK,MODERNA,SYR 1045173,NY,33.0,F,Pfizer-BioNTech COVID-19 Vaccine EUA,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,PVT,,,None known,,None known,['Unevaluable event'],UNK,PFIZER\BIONTECH, 1045176,,33.0,F,"The patient is a 34yo female seen about 1 month ago for SOB - it developed 1 week after the COVID vaccine. She was sent to Cardiology and they diagnosed her with pericarditis and she was started on scheduled NSAIDS. - Cardiology recommended ESR, CRP and CBC and they were negative. - CXR was normal - Echocardiogram was suggestive of pericarditis. Cardiology told her to follow up in 1 month is symptoms did not improve and they have not. Also she stated she has developed mild, intermittent peripheral edema that resolves without intervention but this is new. I am also ordering the cardiac MRI which the cardiologist recommended if symptoms did not improve with NSAIDs.",Not Reported,,Not Reported,Not Reported,,Yes,,01/09/2021,01/17/2021,8.0,MIL,Allegra PRN Lunesta PRN MiraLax.,NONE,Insomnia SAR intermittent constipation.,,NONE,"['C-reactive protein normal', 'Chest X-ray normal', 'Dyspnoea', 'Echocardiogram abnormal', 'Full blood count normal', 'Oedema peripheral', 'Pericarditis', 'Red blood cell sedimentation rate normal']",1,MODERNA,IM 1045177,,37.0,F,"Arm with large area of redness, warmth and induration. Started 2-3 days after injection and lasted until day 7",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/16/2021,3.0,PUB,APAP and Ibuprofen,,,,,"['Erythema', 'Induration', 'Skin warm']",2,PFIZER\BIONTECH,IM 1045178,,20.0,M,CHEST PAIN; SOB; ELEVATED INFLAMATORY MARKERS; ELEVATED TROPONIN; MYOCARDITIS,Not Reported,,Not Reported,Yes,,Not Reported,N,02/18/2021,02/19/2021,1.0,MIL,NONE,NONE,SMOKER 1 PACK/DAY X3 YEARS,,NONE,"['Angiogram', 'Blood creatine phosphokinase', 'Blood creatine phosphokinase MB', 'C-reactive protein increased', 'Chest pain', 'Computerised tomogram thorax', 'Dyspnoea', 'Electrocardiogram', 'Fibrin D dimer', 'Full blood count', 'Inflammatory marker increased', 'Lipase', 'Metabolic function test', 'Myocarditis', 'Red blood cell sedimentation rate', 'SARS-CoV-2 test', 'Troponin increased']",1,MODERNA,IM 1045179,CO,21.0,F,"Pain at injection site began 1-2 hours after and lasted 1 week, tearing axillary pain on same side as injection began next day and lasted 1 week, chills and body aches began next day and lasted ~12 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/11/2021,1.0,UNK,"Zoloft, oral birth control, melatonin",None,None,,"Peas, pears, apricots","['Axillary pain', 'Chills', 'Injection site pain', 'Pain']",1,PFIZER\BIONTECH,IM 1045181,WI,39.0,F,Severe body aches Chills Fever Sweats (changed clothes 4 times because wringing wet) Severe headache Fatigue (slept for 24 hours) Vomiting Nausea Light sensitivity,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,UNK,Lexapro Levothyroxine EnLyte Arnuity Ellipta,"Runny nose, cough, congestion - tested covid negative on February 7th - ?cold? started February 3rd",Asthma Hashimoto?s thyroiditis/hypothyroidism Anxiety/depression IBS Undifferentiated connective tissue disease,,Codeine,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Photophobia', 'Sweating fever', 'Vomiting']",2,MODERNA,IM 1045182,MN,41.0,M,Fever @ 102 degrees F Systemic Shivering Systemic Chills Systemic Muscle Aches Headache Lightheadedness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,SCH,None,None,None,,None,"['Chills', 'Dizziness', 'Headache', 'Myalgia', 'Pyrexia']",2,MODERNA,IM 1045471,PR,51.0,F,"Mild discomfort; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old non-pregnant female patient received the first dose of bnt162b2 (BNT162B2, lot number: EL-1283) , via an unspecified route of administration in the left arm (at 51 years of age) on 22-JAN-2021 at 13:00 as a single dose for Covid-19 Vaccination. Medical history included hypertension and Hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID), hydrochlorothiazide, losartan potassium (HYZAAR). The patient had no known allergies. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 22Jan2021 at 14:30, the patient experienced mild discomfort. No treatment was given for the event. The clinical outcome of the event mild discomfort was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/22/2021,0.0,UNK,SYNTHROID; HYZAAR,,Medical History/Concurrent Conditions: Hypertension (Relevant medical history and concurrent conditions:); Hypothyroidism (Relevant medical history and concurrent conditions:),,,['Discomfort'],1,PFIZER\BIONTECH, 1045472,PR,25.0,F,"Fever; headache; tachycardia; left arm pain; muscle pain; stomach upset; This is a spontaneous report received from a contactable nurse (patient). A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and lot number: EL9282) at the age of 25 years intramuscularly to left arm on 28Jan2021 13:00 at single dose for Covid-19 immunisation in hospital. Medical history included Kyphosis. The patient had no known drug allergy (NKDA). The patient had no concomitant medications. Patient previously the first dose of BNT162B2 at the age of 25 years for Covid-19 immunisation. The patient did not receive other vaccine in four weeks. The patient was not pregnant. The patient did not have COVID prior to vaccination. The patient underwent nasal swab (antigen) test on 20Jan2021 with negative result. On 28Jan2021 16:00 the patient experienced fever, headache, tachycardia, left arm pain, muscle pain and stomach upset. Therapeutic measure was taken as a result of the events and included treatment with PANADOL 500mg. Outcome of events was recovering. No follow-up attempts are possible. No other information was reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Kyphosis,,,"['Abdominal discomfort', 'Headache', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test', 'Tachycardia', 'Vaccination site pain']",2,PFIZER\BIONTECH,OT 1045510,,,F,"Heart was a little bit flippy; Been feeling very weak for several days; Arm has swelled up and went up all the way to my elbow; Arm got very red and went up all the way to my elbow; Gave me the shot at the wrong place towards the front of my arm; Fever today the highest it's been is 101.2 and is now 99.6; Very tired; Joint aches; A spontaneous report was received from a consumer, concerning a female patient of an unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart was a little bit flippy, been feeling very weak for several days, fever today the highest it's been is 101.2 and is now 99.6, very tired, arm has swelled up and went up all the way to my elbow, arm got very red and went up all the way to my elbow, gave me the shot at the wrong place towards the front of my arm. Medical history included paroxysmal supraventricular tachycardia. No concomitant medication was reported. On 23-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via an unknown route for prophylaxis of COVID-19 infection. On an unknown date, after 8 days after the first shot of vaccine, the patient's heart was a little bit flippy, been feeling very weak for several days, today's fever was the highest it's been is 101.2 and is now 99.6, very tired, arm has swelled up and went up all the way to my elbow, arm got very red and went up all the way to my elbow, gave me the shot at the wrong place towards the front of my arm. Laboratory details included body temperature: 101.2 and 99.6. Treatment medication was not reported. Action taken with mRNA-1273 in response to the events were not provided. The outcome of the events, my heart was a little bit flippy, been feeling very weak for several days, fever today the highest it's been is 101.2 and is now 99.6, very tired, my arm has swelled up and went up all the way to my elbow, my arm got very red and went up all the way to my elbow were considered unknown at the time of this report. The outcome of event gave me the shot at the wrong place towards the front of my arm was considered resolved at the time of this report.; Reporter's Comments: This case concerns a female (age unknown) with PMHx of PST had Vaccine administered at inappropriate site, NS unexpected asthenia, cardiac flutter, asthenia, NS expected fever, fatigue, arthralgia, vaccination site swelling, vaccination site erythema. Adverse events occurred 8 days after first dose of mRNA-1273 (lot # unknown). Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: Paroxysmal supraventricular tachycardia (Medical History),,,"['Arthralgia', 'Asthenia', 'Body temperature', 'Cardiac flutter', 'Fatigue', 'Product administered at inappropriate site', 'Pyrexia', 'Vaccination site erythema', 'Vaccination site swelling']",1,MODERNA,OT 1045511,NY,60.0,F,"Red swelling; Red swelling; Injection in left arm but cannot assure it was intramuscular; A spontaneous report was received from a consumer who is a 60-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and got injection in left arm but cannot assure it was intramuscular, red and swelling (injection site erythema and injection site swelling). The patient's medical history was not provided. No concomitant medications were reported. On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) in the left arm for prophylaxis of COVID-19 infection. On 11 Jan 2021, after the first dose of vaccine, the patient confirmed that she was fine but had a small pinhead were the vaccine was injected and was not sure if she got the injection via intramuscularly in the left arm. On 20 Jan 2021, when patient woke up, she found with red swelling that continued to grow at the time of this report. Treatment for the event included unspecified antibiotic. Action taken with mRNA-1273 in response to the events were not provided. The outcome of the events, injection in left arm but cannot assure it was intramuscular was considered resolved on 11 Jan 2021. The outcome of events red swelling was considered not resolved and was continuing at the time o this report.; Reporter's Comments: This case concerns a 60-year-old female with a NS unexpected event of Incorrect route of product administration and NS expected events of Injection site erythema and Injection site swelling. The expected events occurred 10 days after first dose mRNA-1273 (lot # unknown). Treatment included an antibiotic. Based on current available information and temporal association between the use of the product and the start date of the associated adverse events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Incorrect route of product administration', 'Injection site erythema', 'Injection site swelling']",1,MODERNA,OT 1045512,OK,,U,"0.5 mL leaked out of patient's arm; vacination site discharge; A spontaneous report was received from a pharmacist concerning a patient of unknown age and unknown gender who received the Moderna COVID-19 vaccine and experienced incorrect dose administered and Vaccination site discharge. A different nurse administered vaccine to patient and they noticed 0.5mL leak out of patient's arm. Moderna vaccine, it was a second dose, administered to just one patient. Pharmacist wants to know if they should repeat dose. Only 1 injection was involved, and Pharmacist has no patient specific information. Ok for safety to contact. HCP wants in writing. The patient's medical history was not provided. Concomitant product use was not reported by the reporter. On 04 Feb 2021, the patient received their first of two planned doses of mRNA-1273 Batch number not provided on unknown date. Prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 Batch number not provided intramuscularly in the for prophylaxis of COVID-19 infection. On 04 Feb 2021, a different nurse administered vaccine to patient and they noticed 0.5mL leak out of patient's arm., the injection site leaked. Moderna vaccine was a second dose, administered to just one patient. Pharmacist wants to know if they should repeat dose. Only 1 injection was involved, and Pharmacist has no patient specific information. Ok for safety to contact. HCP wants in writing. Treatment information was not provided. Action taken with mRNA-1273 in response to the events incorrect dose administered and Vaccination site discharge was not applicable. The outcome of the event was considered as recovered on 04 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered and Vaccination site discharge for mRNA-1273. There were no reported adverse events associated with this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,02/04/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Incorrect dose administered', 'Vaccination site discharge']",2,MODERNA,OT 1045513,,,F,"UTI after second dose; A spontaneous report was received from healthcare professional concerning a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced UTI after second dose. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 03 Feb 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On an unknown date, after receiving the second dose of vaccination, the patient developed UTI. Treatment included antibiotics. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The outcome for the event, UTI after second dose was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Urinary tract infection'],2,MODERNA, 1045514,NE,48.0,F,"Appendicitis pain; A spontaneous report was received from a nurse concerning a 48-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced appendicitis pain. The patient's medical history was not provided. Concomitant medications reported included omeprazole, venlafaxine hydrochloride, trazodone and spironolactone. (batch number: 041L20A) On 11 Jan 2021, seventeen days prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 041L20A) intramuscularly in her left arm for the prophylaxis of COVID-19 infection. On 28 Jan 2021, after the vaccine administration, the patient experienced appendicitis pain, hence on 30 Jan 2021, she underwent appendicectomy. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event, appendicitis pain was considered unknown at the time of his report.; Reporter's Comments: This case of appendicitis in a 48-year-old, female patient 17 days after the administration of mRNA-1273 vaccine(batch number: 041L20A) as assessed as unlikely associated with the vaccine administration based on then natural history of the disease and based on duration and outcome (appendectomy), it was most likely an ongoing inflammatory process.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/28/2021,17.0,UNK,OMEPRAZOLE; EFFEXOR; TRAZODONE; SPIRONOLACTONE,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Appendicitis'],1,MODERNA,OT 1045515,,,F,"vaccine was injected directly into her vein/artery; bulging veins; nail beds turned blue; A spontaneous report was received from a consumer concerning a female patient, of unknown age, who developed bulging veins and nail beds turned blue after receiving a first dose of Moderna's COVID-19 vaccine administered directly into her vein/artery. The patient's medical history was not provided. No relevant concomitant medications were reported. On 07-JAN-2021 prior to the onset of the events, patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) unknown route of administration. On 03-FEB-2021, patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) unknown route of administration for prophylaxis of COVID-19 infection. The patient was administered mRNA-1273 vaccine directly into vein/artery, on 07-JAN-2021, and developed bulging veins and nail beds turned blue. Treatment for the event included ice pad. EMTs checked blood pressure and monitor the patient for several minutes. There was no change planned to the dosing schedule of mRNA-1273 in response to the event. The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The event, vaccine administered directly into vein/artery was considered resolved. The outcome for the event bulging veins and nail beds turned blue not provided. .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. Further information is requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Cyanosis', 'Incorrect route of product administration', 'Superficial vein prominence']",2,MODERNA, 1045516,CA,,F,"Breast cancer; A spontaneous report was received on 05 Feb 2021 from a consumer concerning an unknown age, female patient who received Moderna's COVID-19 vaccine and diagnosed with breast cancer. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, patient received their first of two planned doses of mRNA-1273(Lot number: unknown), for the prophylaxis of COVID-19 infection. On 03 Feb 2021, the patient was diagnosed with breast cancer. Action taken the second dose of mRNA-1273 in response to the events was not reported. The outcome of the event, breast cancer was not resolved. The assessment of the causality by reporter was, there was no relation between the vaccine and the diagnosis of cancer, but as the event occurred after the administration of the Moderna COVID-19 vaccine.; Reporter's Comments: Based on the current available information, the event was diagnosed 15 days after the administration of mRNA-1273. Due to the nature of development of breast cancer, the event was assessed as unlikely related. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,02/03/2021,14.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Breast cancer'],1,MODERNA, 1045517,NE,,M,"Sharp pains in feet (neuropathy); Bad diarrhea; Felt yucky and not feeling good at all; Arm swollen on the same side of injection; A spontaneous report was received from a consumer who was also a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced sharp pains in feet (neuropathy)/ neuropathy peripheral, arm swollen on same side of injection/ injection site swelling, bad diarrhea/ diarrhea, and feeling yucky and not good at all/ malaise. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03 Feb 2021, approximately at 12:00 pm, the patient received their first of two planned doses of mRNA-1273 (Lot number: 010M20A) intramuscularly for prophylaxis of COVID-19 infection. On 04 Feb 2021, the patient started experiencing symptoms of sharp pains in his feet (neuropathy), bad diarrhea, felt yucky and not feeling good at all. On 05 Feb 2021, the patient reported that the symptoms did not abate, however they were improving. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, sharp pains in feet (neuropathy), arm swollen on same side of injection, bad diarrhea and felt yucky and not good at all, was resolving.; Reporter's Comments: Based on the current available information and a temporal association between the use of the product and the onset of the reported events a causal relationship cannot be excluded. Injection site swelling is consistent with the known safety profile of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Diarrhoea', 'Malaise', 'Neuropathy peripheral', 'Vaccination site swelling']",1,MODERNA,OT 1045518,NJ,76.0,F,"Something occurred in the syringe that not the 0.5 mL entered her arm and part spilt out; Something occurred in the syringe that not the 0.5 mL entered her arm and part spilt out; A spontaneous/solicited report was received from a consumer concerning herself, a 76 year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported that something occurred in the syringe so that the 0.5 mL did not enter her arm and part spilt out/device connection issue and underdose. The patient's medical history included breast cancer and cholesterol (not further specified). Products known to have been used by the patient, within two weeks prior to the event, included medicine for blood pressure (not further specified), vitamins, atorvastatin calcium and nebivolol hydrochloride. On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, during administration, the patient reported that something occurred in the syringe so that the 0.5 mL did not enter her arm and part spilt out. No treatment information was provided. The second dose of mRNA-1273 was scheduled for 18 Feb 2021. Action taken with mRNA-1273 in response to the events was not reported. The events, something occurred in the syringe so that the 0.5 mL did not enter her arm and part spilt out, were considered resolved on 22 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered, and underdose for mRNA-1273, lot # 026L20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,UNK,VITAMINS NOS; LIPITOR; BYSTOLIC,,Medical History/Concurrent Conditions: Blood cholesterol abnormal; Breast cancer,,,"['Incorrect dose administered', 'Underdose']",1,MODERNA,OT 1045519,TX,,F,"Warm to the touch injection site; Bruise on injection site; Itching left arm injection site; Redness on the side of the injection site; Pain left arm (with movement); Urinary tract infection; Headache; A spontaneous report was received from a consumer, concerning herself, a 71-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed urinary tract infection, warm to the touch injection site, pain left arm (with movement), bruise on injection site, itching left arm injection site, headache and redness on the side of the injection site. The patient's medical history provided included cystitis. Concomitant product use was not provided by the reporter. On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27 Jan 2021, after the first dose of vaccine administration, the patient developed headache. On 03 Feb 2021 (Wednesday) the patient experienced urinary tract infection and took one capsule of cephalexin 500mg. Later, on 04 Feb 2021, the patient's left arm of injection site had started itching and her arm was hurt on movement. When she checked in the mirror, she noticed a bruise on injection site and the side of the injection site was red and also was little warm to the touch. She thought the skin reaction might have been triggered by the cephalexin, hence she did not continue the antibiotic, but she also confirmed that she had no reactions anywhere else on the body. Action taken with mRNA-1273 in response to the events were unknown. The outcome of event, headache was considered to be resolved on 28 Jan 2021. The outcome of the events, urinary tract infection, warm to the touch injection site, pain left arm (with movement), bruise on injection site, itching left arm injection site and redness on the side of the injection site were considered unknown at the time of this report.; Reporter's Comments: Based on the current information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Patient's medical history of cystitis is a confounder for urinary tract infection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Cystitis,,,"['Headache', 'Urinary tract infection', 'Vaccination site bruising', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site pruritus', 'Vaccination site warmth']",1,MODERNA,OT 1045520,MI,84.0,F,"Possible cellulitis; left arm stiff; itchy redness on the area of injection; itchy redness on the area of injection; A spontaneous report was received from consumer concerning a 84-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy redness the injection site on her left arm, her left arm is stiff, and possible cellulitis. The patient's medical history and concomitant product use were not provided. On 28-Jan-2021, the patient received the first of two planned doses of mRNA-1273, (Lot number 007M20A), intramuscularly into her left arm for prophylaxis of Covid-19 infection. On the morning of 05-Feb-2021 the patient noticed, itchy redness, 4X6 inches in size, 4 inches below the injection site on her left arm and her left arm is stiff. The patient was examined by her doctor that same day and was prescribed Doxycycline for a possible cellulitis. No relevant laboratory tests were ordered. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the events, itchy redness, 4X6 inches in size, 4 inches below the injection site on her left arm and her left arm is stiff and possible cellulitis were unknown.; Reporter's Comments: This case concerns an 84-year-old female who experienced a serious unexpected event of cellulitis along with a NS unexpected events of stiffness and injection site pruritus and NS expected event of injection site erythema. The events occurred 9 days after the first dose of mRNA-1273. Treatment included doxycycline. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,02/05/2021,8.0,UNK,,,Medical History/Concurrent Conditions: No adverse effect (no medical history provided),,,"['Cellulitis', 'Injection site erythema', 'Injection site pruritus', 'Musculoskeletal stiffness']",1,MODERNA,OT 1045521,IL,,F,"Fainted; Diarrhea; Nausea; Warm body temperature; A spontaneous report was received from a consumer, regarding herself, a 82-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainted, diarrhea, nausea and warm body temperature. The patient's medical history reported included ulcerative colitis. Concomitant product use was not provided. On 04 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot Number: 038K20A) intramuscularly for prophylaxis of COVID-19 infection. On 04 Feb 2021, in the evening, after receiving the vaccine, the patient was fainted and started to experience diarrhea, nausea and warm body temperature. The event fainted was considered to be medically significant. Treatment for the events not provided. Action taken with the second dose of mRNA-1273 in response to the events were not reported. The outcome for the events, fainted, diarrhea, nausea and warm body temperature were resolved on 05 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,UNK,,Ulcerative colitis,,,,"['Diarrhoea', 'Nausea', 'Pyrexia', 'Syncope']",1,MODERNA,OT 1045522,GA,,F,"Third of the vaccine leaked out of patients arm; A spontaneous report was received from a nurse, concerning a 57-year-old female patient, who received Moderna's COVID-19 vaccine and the third of vaccine leaked out of patient's arm. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 05 Feb 2021, prior to the onset of the event, the patient received her first of two planned doses of mRNA-1273 (Lot number: 013M20A) for prophylaxis of Covid-19 infection. On 05 Feb 2021, while nurses was administering patient's first dose of vaccine, the dose was leaked out of patient's arm (almost third of the dose leaked out). However, the nurse was not exposed to the vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not reported. The event, third of vaccine leaked out of patient's arm was considered resolved on 05-Feb-2021.; Reporter's Comments: This case report concerns a non-serious unexpected event of a 57-year-old female patient who experienced third of vaccine leaked out of patient's arm. (Incomplete dose administered) for mRNA-1273, lot # 013M20A. There were no reported AEs associated with this case of incomplete dose administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Incorrect dose administered'],1,MODERNA,OT 1045523,FL,,M,"AFIB; really tired; chest pain; A spontaneous report was received from a consumer concerning a himself, a 75-year-old male who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial fibrillation, chest pain and really tired. The patient's medical history included atrial fibrillation with ablation 3 years ago. No relevant concomitant medications were reported. On 01 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lo038A20A) intramuscularly for prophylaxis of COVID-19 infection. On 02 Feb 2021, the patient woke up at 2:30 a.m. with chest pain, which ""has"" subsided (date not reported). On 03 Feb 2021, the patient was really tired. On 04 Feb 2021, the patient felt great. On 05 Feb 2021, at 6:30 a.m., the patient went into atrial fibrillation. Action taken with mRNA-1273 in response to the events was not reported. The event of chest pain was recovered/resolved. The event of really tired was recovered/resolved on 04 Feb 2021. The outcome of the event of atrial fibrillation was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's age and history of atrial fibrillation with ablation are risk factors and confounds causality assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,UNK,,,"Medical History/Concurrent Conditions: AFib (ablation ""3 years ago"")",,,"['Atrial fibrillation', 'Chest pain', 'Fatigue']",UNK,MODERNA,OT 1045524,WI,50.0,M,"Tansverse myelitis; A spontaneous report was received from a physician, who was also a 50-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced transverse myelitis. The patient's medical history included cervical disc disease and low testosterone. Concomitant medications included testosterone cypionate and anastrozole. The patient reported that he had no acute illnesses at the time of vaccination and up to one month before. He had no allergies to medications, food, or other products. On 30 Dec 2020 at 12:00 pm, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On or about 07 Jan 2021, the patient began experiencing numbness in both feet. Thinking it could be related to his prior cervical disc disease causing myelopathic symptoms, hence, the patient saw a spine surgeon, who ordered a cervical magnetic resonance image (MRI) which revealed of no acute changes. On or about 18 Jan 2021, the patient began having problems with leg weakness and difficulty in standing and walking. That same day, he underwent urgent MRIs of his thoracic and lumbar spines which showed a lesion on the anterior thoracic cord. The patient was referred to a neurologist who diagnosed the patient with transverse myelitis. Subsequently, follow-up MRIs with contrast, MRI of the brain, and lumbar puncture for CSF analysis were completed but no other causes of his symptoms were identified. At the time of this report, the patient's legs were always numb (numbness propagated proximally with activity), his legs were weak, gait was unstable, he noted sexual dysfunction, and he had frequent ""electrical"" sensations. A follow-up thoracic MRI was completed on 05 Feb 2021 (results pending at time of this report). Treatment for the event included intravenous immunoglobulin (IVIG) infusions for five days (to start on 06 Jan 2021). The action taken with mRNA-1273 in response to the event was withdrawn (regarding dose two, the patient reported: ""N/A not given""). The event, transverse myelitis, was considered not resolved at the time of this report. The physician assessed the event of transverse myelitis as related to mRNA-1273.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, it is noted that follow-up MRIs with contrast, MRI of the brain, and lumbar puncture for CSF analysis were completed and no other causes of his symptoms were identified but confirmation of the event was not reported. Also, the patient's comorbidities (cervical disc disease and low testosterone) may contribute to the patient's symptoms and confounds causality assessment. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/07/2021,8.0,UNK,TESTOSTERONE CYPIONATE; ANASTROZOLE,Cervical disc disease; Testosterone low,,,,"['Lumbar puncture', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging neck', 'Magnetic resonance imaging thoracic', 'Myelitis transverse']",1,MODERNA,OT 1045525,NY,,F,"Possible vaccine administration via Subcutaneous Route; A spontaneous report was received from a nurse concerning a 36 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced Subcutaneously Administered vaccine (incorrect route of product administration). The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. The patient received their second of two planned doses of mRNA-1273 LOT # 013L20A on 05-FEB-2021 for prophylaxis of COVID-19 infection. Female Nursing Practitioner called to report possible vaccine administration via Subcutaneous route. The patient had not reported any side effects. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The event, Subcutaneously Administered vaccine was considered recovered/resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273, lot # 013L20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Incorrect route of product administration'],2,MODERNA,OT 1045526,TX,79.0,F,"Hypoxic; Tested positive for COVID; A spontaneous report was received from a physician concerning a 79-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypoxic and tested positive for COVID-19. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12 Jan 2021, approximately 1 day prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 13 Jan 2021, the patient started showing symptoms of COVID and she tested positive for the virus that same day. She received Regeneron antibody infusion. On 16 Jan 2021 (day 4), the patient became hypoxic and was admitted to the hospital for 2 days. The patient was discharged not needing oxygen. She was greatly improved on Day 7. Treatment provided included Regeneron antibody infusion. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events hypoxia and COVID-19 was unknown.; Reporter's Comments: The patient had COVID symptoms one day after mRNA-1273 vaccine administration. The events were consistent with increased risk of respiratory complications associated with viral infection in pandemic set up. Based on test results the events are assessed as unlikely related to mRNA-1273.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/12/2021,01/13/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['COVID-19', 'Hypoxia', 'SARS-CoV-2 test positive']",1,MODERNA,OT 1045527,NJ,80.0,M,"Full amount of the dose was not fully administered; Some of the vaccine leaked down the patient's arm; A spontaneous report was received from a healthcare professional concerning an 80-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the full amount of the dose was not fully administered (LLTs: vaccine underdose / syringe connection issue). The patient's medical history was not provided. No concomitant medications were reported. On 04 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 04 Feb 2021, a physician's assistant administered the Moderna COVID-19 vaccine to a patient and stated, that the full amount of the dose was not full administered. Some of the vaccine leaked down the patient's arm. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, full amount of the dose was not fully administered issue and some of the vaccine leaked down the patient's arm, were considered resolved on 04 Feb 2021.; Reporter's Comments: The reporter refers to a case of vaccine underdose and syringe connection issue for mRNA-1273 vaccine, batch number not provided, with no associated AEs. Causality of these events is not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Device connection issue', 'Underdose']",1,MODERNA,OT 1045528,NY,,F,"Vaccine administration via Subcutaneous Route; A spontaneous report was received from a nurse concerning a 28-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced Subcutaneously Administered vaccine/ incorrect route of product administration. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 Batch number not provided. The patient received their second of two planned doses of mRNA-1273 (Lot number 013L20A) via subcutaneous route for prophylaxis of COVID-19 infection. Female Nursing Practitioner called to report Possible vaccine administration via Subcutaneous Route, on 05FEB2021. The patients have not reported any side effects. Treatment information was not provided. The event, Subcutaneously Administered vaccine was considered recovered/resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 (Lot number 013L20A). There were no associated AEs with this event of inappropriate route of vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported Medical history),,,['Incorrect route of product administration'],2,MODERNA,OT 1045529,FL,,U,"the patient received part of the dose; did not receive the full dose as part of the liquid spilled out; A spontaneous report was received from a healthcare professional concerning a patient, of unknown gender and age, who was administered Moderna's COVID-19 vaccine and received part of the dose and did not receive the full dose as part of the liquid spilled out (device connection issue). The patient's medical history was not provided. No relevant concomitant medications were reported. On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly for prophylaxis of Covid-19 infection. It was reported that during administration of the Moderna COVID 19 vaccine on 05 Feb 2021, the patient did not receive the full dose as part of the liquid spilled out. Consent for follow up given. No treatment information was provided. Action taken with the first dose of mRNA-1273 in response to the event was not reported. The events, received part of the dose and did not receive the full dose as part of the liquid spilled out, were considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of incorrect dose administered, and device connection issue for mRNA-1273, lot # 031L20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Device connection issue', 'Incorrect dose administered']",1,MODERNA,OT 1045530,NY,,M,"Vaccine ran down individual's arm; syringe which malfunctioned; A spontaneous report was received from a pharmacist concerning a 68, year old, male patient who experienced an incomplete dose administration of Moderna's COVID-19 vaccine, when the syringe malfunctioned and the vaccine ran down the patients arm. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 05 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029L20A) intramuscularly, the injection side/site not given for prophylaxis of COVID-19 infection. The reporter, a pharmacist, called from a clinic. On 05 Feb 2021, one of the immunizers attempted to give a second dose using the agency supplied syringe which, malfunctioned and the vaccine ran down the patient's arm. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the event(s) was not provided. The events incomplete dose administration of vaccine and syringe issue were considered recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered, and syringe issue for mRNA-1273, lot # 029L20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Incorrect dose administered', 'Syringe issue']",2,MODERNA,OT 1045531,,,F,"developed cirrhosis; scalp infection; Headache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed cirrhosis, scalp infection and headache. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On unknown date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, the patient who developed cirrhosis and scalp infection. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events who developed cirrhosis, scalp infection and headache was unknown.; Reporter's Comments: Very limited information regarding the events of cirrhosis and scalp infection have been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Headache', 'Hepatic cirrhosis', 'Skin disorder']",1,MODERNA,OT 1045532,MN,,U,"Vaccine administered without waiting fifteen minutes at room temperature; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and vaccine administered without waiting fifteen minutes at room temperature. The patient's medical history was not provided. No relevant concomitant medications were reported. It was not reported when the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. It was stated from the reporter, we had vaccine that had been completely thawed, and it was administered without waiting fifteen minutes at room temperature. This was at a Mas Vaccination site and we have no knowledge of how many were vaccinated prior to the vials being at room temperature. Reporter made an estimated guess of fifteen to twenty individuals who have been vaccinated prior to the vaccine coming to room temperature. Reporter was looking for clarification on if the vaccine always needed to be brought to room temperature and why. She stated if we need to always have the vaccine at room temperature before vaccinating, that it was not clear in the instructions. No further information was provided. No treatment information was provided. Action taken with RNA-1273 in response to the event was not applicable. The outcome of the event was considered as recovered.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administration error'],1,MODERNA,OT 1045533,,,F,"a leakage from the syringe; a leakage from the syringe; A spontaneous report was received from a consumer, concerning a 25 year-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced leakage from the syringe while it was being administered/device connection issue, underdose. The patient's medical history was not provided. No concomitant medications were reported. On 05 Feb2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 032L20A), intramuscular in the right arm for prophylaxis of COVID-19 infection. On the same day, while the vaccine was being administered, the patient reported there was leakage from the syringe and she questioned a vaccine underdose. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The event leakage from the syringe was considered as resolved.; Reporter's Comments: This report refers to a case of device connection issue, and incorrect dose administered for mRNA-1273, lot # 032L20Awith no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Device connection issue', 'Incorrect dose administered']",2,MODERNA,OT 1045534,TX,,M,"Tested positive for covid-19; Upset stomach; Dry cough; Feeling unwell; A spontaneous report was received from a consumer, concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine and tested positive for Covid-19 and experienced upset stomach, dry cough and did not generally feel well. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 14 Jan 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of Covid-19 infection. On 15 Jan 2021, after the first dose of vaccine, the patient was presented with upset stomach, dry cough, and he did not generally feel well. On 26 Jan 2021, the patient tested positive for Covid-19 and was hospitalized from 29 Jan 2021 to 02 Feb 2021. No further information was provided at the time of this report. Reporter denied consent to follow-up. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome for events, tested positive for Covid-19, upset stomach, dry cough, and did not generally feel well were considered to be unknown.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of SARS-CoV-2 test positive after receiving mRNA-1273. Very limited information regarding this event has been provided at this time. The event of Covid test positive is assessed as unlikely related to mRNA-1273. There is no consent for follow-up, so no further information has been requested.",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,01/14/2021,01/15/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Abdominal discomfort', 'Cough', 'Malaise', 'SARS-CoV-2 test positive']",1,MODERNA,OT 1045535,,17.0,F,"17-year-old received the first shot of moderna vaccine; A spontaneous report was received from a nurse concerning a 17-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced 17-year-old received the first shot of Moderna vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, approximately 0 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient received their first dose of the vaccine at 17 years old. She was turned away from getting her second dose due to her age. No treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown. The event, 17-year-old received the first shot of Moderna vaccine, was considered resolved on an unknown date.; Reporter's Comments: This case report concerns a non-serious unexpected event of 17-year-old received the first shot of Moderna vaccine (inappropriate age at vaccine administration for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of inappropriate age at vaccine administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1045536,,,U,"Second dose of the Moderna vaccine was light pink color; Color of the vaccine is pink; A spontaneous report was received from a consumer, concerning a patient of unknown age and gender, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), which resulted in events, second dose of the Moderna vaccine was light pink color/poor quality product administered and color of the vaccine is pink/product colour issue. The patient's medical history was not provided. No concomitant medications were reported. On an unknown date, prior to the onset of events, the patient received their first dose of mRNA-1273 (Lot number: unknown), for prophylaxis of COVID-19 infection. The patient stated that the vaccine was supposed to be white to off-white in color. The patient received the second dose of the Moderna vaccine on an unknown date and the color of the vaccine was light pink. The patient was concerned if the vaccine was stored improperly. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, second dose of the Moderna vaccine was light pink color and color of the vaccine is pink, were reported as resolved on an unknown date.; Reporter's Comments: This report refers to a case of poor quality product administered, and product color issue for mRNA-1273 with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Poor quality product administered', 'Product colour issue']",2,MODERNA,OT 1045537,TN,,M,"Covid-19; Strep throat; Slid down the wall and passed out; Hacky cough; Slight headache; Tired; Fever; A spontaneous report was received from a consumer concerning a 73-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hacky cough, slight headache, tired, slight fever of 100.4, covid-19, strep throat and passed out. The patient's medical history included artificial hips. Concomitant medications reported included salbutamol, fluticasone propionate, salmeterol xinafoate, salbutamol sulfate, apixaban, mirabegron, metoprolol, cetirizine hydrochloride, colecalciferol, zinc, ascorbic acid and rutoside for unspecified indication. On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection. Reporter stated that the patient was not aware of being exposed to COVID on 10 Jan 2021. They found out the following week after receiving the vaccine. The patient had COVID test on 19 Jan 2021 and tested positive. On 14 Jan 2021, the patient developed hacky cough, slight headache, tired, slight fever of 100.4 degree fahrenheit. The treatment information included fluticasone propionate, salbutamol, steroids, montelukast and azithromycin. On 17 Jan 2021, the patient got up to go to the bathroom and slid down the wall and passed out. The treatment information included fluticasone propionate, salbutamol, steroids, montelukast and azithromycin. Action taken with RNA-1273 in response to the event was not provided. The outcome of the events hacky cough, slight headache, tired, slight fever of 100.4, covid-19, strep throat and passed out was unknown.; Reporter's Comments: This case concerns a 73-year-old male with a serious expected event of loss of consciousness along with a NS unexpected COVID-19, streptococcal pharyngitis, cough and NS expected fever, headache, fatigue. Event onset 9 days after the first dose of mRNA-1273. Treatment included fluticasone, salbutamol, steroids, azithromycin. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/14/2021,3.0,UNK,ALBUTEROL HFA; ADVAIR; PROVENTIL [SALBUTAMOL SULFATE]; ELIQUIS; MYRBETRIQ; METOPROLOL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN D [COLECALCIFEROL]; ZINC; VITAMIN C COMPLEX [ASCORBIC ACID;RUTOSIDE],,Medical History/Concurrent Conditions: Hip replacement (Artificial hips),,,"['Body temperature', 'COVID-19', 'Cough', 'Fatigue', 'Headache', 'Loss of consciousness', 'Pharyngitis streptococcal', 'Pyrexia', 'SARS-CoV-2 test', 'Streptococcus test']",1,MODERNA,OT 1045538,FL,,F,"bell's pausy; strange feeling in my lip; stiff neck; A spontaneous report was received from a consumer concerning a 73-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's Palsy (facial paralysis), stiff neck (musculoskeletal stiffness), and a strange feeling in her lip (oral discomfort). The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included vitamins, atorvastatin calcium and calcium On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 038K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 04 Feb 2021, the patient developed a very stiff neck and had a restless sleep. On 06 Feb 2021, the patient reported awaking with a strange feeling in her lip. She was advised by her primary care physician. On 07 Feb 2021, the symptoms had worsened, and her facial muscle had twisted. Treatment for the event included prednisone and valacyclovir. Action taken with mRNA-1273 in response to the events was not provided/unknown. The events, Bell's Palsy, stiff neck and strange feeling in lip, was considered not recovered/not resolved.; Reporter's Comments: Although a temporal relationship exists, there is not enough information to assess the causal relationship of the reported events with the administration of mRNA-1273 (Batch number: 038K20A). Critical details such as patient's medical history and relevant diagnostic test are lacking. Additional information have been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/04/2021,6.0,UNK,VITAMINS NOS; LIPITOR; CALCIUM,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Facial paralysis', 'Musculoskeletal stiffness', 'Oral discomfort']",1,MODERNA,OT 1045539,MI,17.0,F,"Hot flashes; Tired; 17-year old inadvertently given the first dose of the vaccine; A spontaneous report was received from a parent whose 17-year-old, female daughter received Moderna's COVID-19 Vaccine (mRNA-1273) resulting in hot flashes, and tired. The patient's medical history was not provided. No relevant concomitant medications were reported. On 06 Feb 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 08 Feb 2021, the patient's father reported his daughter was given the Moderna vaccine in error as she is only 17. The patient experienced hot flashes and was tired after receiving the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, vaccine given to a 17-year old, was considered resolved on 06 Feb 2021. The outcomes for events, hot flashes and tired, were not reported.; Reporter's Comments: This report refers to a 17-year old female patient who received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection with reported events of hot flashes and was tired. Based temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/06/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Fatigue', 'Hot flush', 'Product administered to patient of inappropriate age']",1,MODERNA,OT 1045540,,,F,"death; hemiparesis; respiratory failure; Aphasia; SARS-COV-2 test positive; cough; A spontaneous report was received from other health care professional concerning a 32- year -female patient who received Modena's COVID-19 vaccine (mRNA-1273) and experienced aphasia, cough, death, endotracheal intubation, hemiparesis, respiratory failure and SARS-COV-2 tested positive. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch 039k20A) intramuscularly on left arm for prophylaxis of COVID-19 infection. Approximately, one day later, patient developed cough and on treatment with azithromycin for one week. On 03-jan-2021, she experienced left sided weakness and aphasia and was shifted to hospital. Patient was confirmed COVID-19 positive which required intubation for acute hypoxic respiratory failure secondary to COVID-19. No laboratory data was provided. Action taken with mRNA-1273 in response to the events aphasia, cough, death, endotracheal intubation, hemiparesis, respiratory failure and SARS-COV-2 tested positive not applicable. On an unknown date, the outcome of the events aphasia, cough, death, endotracheal intubation, hemiparesis, respiratory failure and SARS-COV-2 tested positive was fatal. On 04 Jan 2021, the patient passed away due to the unknown cause. Autopsy results were unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related. The cause of death was not reported. Autopsy results were unknown.; Reported Cause(s) of Death: Unknown cause of death",Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,UNK,,Endotracheal intubation,,,,"['Aphasia', 'COVID-19', 'Cough', 'Death', 'Hemiparesis', 'Respiratory failure']",1,MODERNA,OT 1045541,CA,49.0,F,"Hives really stinging and burning up to armpits, down to lower thigh and on neck and arm; Arm burning; Arm really itchy; Upper lip, side of nose, lower chin swollen; Lower chin hurts; Throat kind of scratchy; Allergic reaction; When drinking and eating food, something stuck on throat, like airpipe not smooth; Arm and legs had hives; Bump on scalp, getting bigger; Groggy; Something in throat, like choking; Left arm hurt; Left arm was swollen; Lower lip swollen; A spontaneous report was received from a consumer, a 49 year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced Allergic reaction, left arm hurt/pain in extremity, left arm was swollen/peripheral swelling, bump on scalp, getting bigger/mass, scalp bump itchy/pruritus, arm and legs had hives/urticaria, groggy/somnolence, something in throat, like choking/choking sensation, lower lip swollen/lip swelling, when drinking and eating food, something stuck on throat, like airpipe not smooth/foreign body in throat, backside hives/urticaria, upper lip, side of nose, lower chin swollen/swelling face, lower chin hurts/facial pain, throat kind of scratchy/throat irritation, arm really itchy/pruritis,arm really sting/pain, arm burning/burning sensation, stomach side, both full of big, patchy hives/urticaria, hives really stinging and burning up to armpits, down to lower thigh and on neck and arm/pain, and still has a lot of hives/urticaria. The patient's medical history was not provided. Concomitant product use was not provided. On, 10 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 037K2DA). On 04 Feb 2021, a day prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Batch number: 015M20A) for COVID-19 infection prophylaxis. On 05 Feb 2021, the patient's left arm was swollen and hurt. Around 6:00 a.m., she put her hand on her scalp, and she felt a bump. After 15 minutes, she touched the bump again and it was getting bigger and itchy. Beside that bump there was another bump, so she took diphenhydramine. At 9:30, she felt the bumps were spreading on her scalp. Then the patient saw that she had real hives on her arm. Thirty minutes later, she noticed her legs had a lot of hives too. A nurse told her it was an allergic reaction. She stated she knew herself and had never had an allergic reaction like this. She took 2 diphenhydramine and when she got home at 12:00 p.m., she felt groggy and fell asleep. When she woke up, there was something in her throat, like she was choking. Her lower lip was swollen. She had her husband take her to the emergency room (ER). They treated her with an intravenous (IV) line and some medication (unspecified). They administered an epinephrine shot, which helped. She was released at 11:00 p.m. On 06 Feb 2021, the patient felt alright, but when she was drinking and eating food, something was stuck on her throat, like her airpipe was not smooth. She saw that on her backside, the hives flared up again. The patient went back to the emergency room to get shots and steroids (both unspecified). They prescribed her some medication and released her. After that, the hives were controllable. On 07 Feb 2021, the patient woke up and her upper lip, side of her nose, and lower chin were swollen. She stated her chin hurt too. The patient's throat was kind of scratchy and she still had the hives. She went back to the ER, they gave her some shots (unspecified), and sent her home again. The patient stated she was very uncomfortable and that she'd never been sick and hadn't been to the hospital for a long time. On 08 Feb 2021, the patient woke up and her arm was really itchy. Her arm was really stinging, burning, and swollen. She stated that her ""stomach on her side part, both of them are really full of big, patchy hives"". The hives were really stinging and burning. She reported that they went up to her armpits and down to her lower thigh. She said the worst was on her neck and arm. She couldn't tolerate it so she went back to the ER that night. The doctor gave her a shot of epinephrine, which helped a lot. She believes it eased the swelling and the pain. On 09 Feb 2021, she still had a lot of hives and they were still was flaring up. She reported that she couldn't go to work, and she felt really uncomfortable. She stated that was the first time that she has had an allergic reaction from a shot and that she never has had an adverse reaction to any shot or any medication. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The event, still has a lot of hives, was considered not resolved. The outcome of the events, Allergic reaction, left arm hurt, left arm was swollen, bump on scalp, getting bigger, scalp bump itchy, arm and legs had hives, groggy, something in throat, like choking, lower lip swollen, when drinking and eating food, something stuck on throat, like airpipe not smooth, backside hives, upper lip, side of nose, lower chin swollen, lower chin hurts, throat kind of scratchy, arm really itchy, arm really sting, arm burning, stomach side, both full of big, patchy hives, hives really stinging and burning up to armpits, down to lower thigh and on neck and arm, was considered unknown.; Reporter's Comments: This case concerns a 49 Y/O F with serious expected allergic reaction along with serious unexpected choking sensation, throat irritation, pain, and NS unexpected urticaria, pruritus, burning sensation, extremity pain, scalp mass, itchy scalp, face swelling lip swelling, facial pain, throat foreign body. Event onset 27 days after first and 1 day after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,02/05/2021,26.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Burning sensation', 'Choking sensation', 'Facial pain', 'Foreign body in throat', 'Hypersensitivity', 'Lip swelling', 'Mass', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Somnolence', 'Swelling face', 'Throat irritation', 'Urticaria']",1,MODERNA,OT 1045542,,,U,"I can't raise my arm to a horizontal position; Pain is starting to go to my back; Pain is starting to go to my head; Instead of going into the side of my arm, they put it almost vertically down into the joint; joint is hurting like crazy; A spontaneous report was received from a consumer concerning a patient, of unknown gender and age, who was administered Covid-19 vaccine as follows: instead of going into the side of his arm, they put it almost vertically down into joint/ MedDRA PT: product administered at inappropriate site and experienced it is hurting like crazy/ MedDRA PT: vaccination site joint pain, can't raise my arm to a horizontal position/ MedDRA PT: vaccination site joint movement impairment, pain is starting to go to my back/ MedDRA PT: back pain, and pain is starting to go to my head/ MedDRA PT: headache. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 032L20A) for prophylaxis of Covid-19 infection. The patient reported that instead of going into the side of their arm, they put it almost vertically down into joint and it is hurting like crazy. Two days later, it is getting worse, and the patient can't raise their arm to a horizontal position. The patient also stated that pain is starting to go to their back and their head. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events of it is hurting like crazy, can't raise my arm to a horizontal position, pain is starting to go to my back, and pain is starting to go to my head, was considered as unknown. The event, vaccine instead of going into the side of his arm, they put it almost vertically down into joint, was considered recovered.; Reporter's Comments: The events of vaccination site joint pain, vaccination site joint movement impairment, backpain and headache developed after first dose of mRNA-1372. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/20/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Back pain', 'Headache', 'Product administered at inappropriate site', 'Vaccination site joint movement impairment', 'Vaccination site joint pain']",1,MODERNA,OT 1045543,,,M,"Mini stroke; Tingling sensation; Numbness at the right side of the body from face down to foot; A spontaneous report was received from a HCP concerning a male patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced tingling sensation and numbness at the right side of the body from face down to the foot. The patient's medical history was reported as diabetic and was taking medications for diabetes but did not provide exact name of the medication. No relevant concomitant medications were reported. 24 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 29 Dec 2020, 5 days after the dose of injection, the patient experienced and experienced tingling sensation and numbness at the right side of the body from face down to the foot. The patient was taken to ER and patient was diagnosed with mini stroke at the ER. No Laboratory details provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events experienced tingling sensation and numbness at the right side of the body from face down to the foot was Unknown.; Reporter's Comments: The events developed on five day after first dose of mRNA-1372. Paresthesia, and hypoesthesia were consistent with increased risk of cerebrovascular accidents associated with history of diabetes. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/24/2020,12/29/2020,5.0,UNK,,Diabetes,,,,"['Cerebrovascular accident', 'Hypoaesthesia', 'Paraesthesia']",1,MODERNA, 1045544,IL,,M,"Early sing of anaphylactic reaction; Face was bright orange; A spontaneous report was received from a consumer concerning a 71 years old, male patient who experienced early sign of anaphylactic reaction (anaphylactic reaction), and face was bright orange (erythema). The patient's medical history included anaphylactic reaction since an unknown date, high blood pressure since an unknown date, anxiety since an unknown date and pain since an unknown date. Products known to have been used by the patient, within two weeks prior to the event, included High blood pressure medication, Pain medication, Anxiety medication and Vitamins all since an unknown date at unknown dose, frequency, route and formulation. On 10-Feb-2021, approximately 20 minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A) in the left arm for prophylaxis of COVID-19 infection. The patient experienced anaphylactic reaction and face was bright orange on 10-Feb-2021 after receiving the vaccine. Patient was treated in the ER and stayed there for four hours while the symptoms slowly resolved. Patient indicated face was 75% back to normal while in ER. Treatment for the event included steroid injection, Zicam and steroid tablets. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The event(s), early sign of anaphylactic reaction, and face was bright orange were considered resolved or recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (within 20 minutes after receiving the vaccine), a causal relationship cannot be excluded. Further information is requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,UNK,VITAMIN A NOS,Anxiety; Blood pressure high; Pain,Medical History/Concurrent Conditions: Anaphylactic reaction,,,"['Anaphylactic reaction', 'Erythema']",1,MODERNA, 1045545,CA,,M,"Bell's Palsy; A spontaneous report was received from a consumer concerning a 70-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed Bell's Palsy. The patient's medical history was not provided. No relevant concomitant medications were reported. On 09 Feb 2021 he patient received their first of two planned doses of mRNA-1273 (BATCH # 042C20A) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection. Consumer was a 70-year-old male that received the first dose of the Moderna COVID-19 vaccine on 09 Feb 2021, in the left upper arm. The patient experienced Bell's Palsy after the first dose on 09 Feb 2021. No further information was reported. No treatment information was provided. Action taken with RNA-1273 in response to the event was unknown. The outcome of the event Bell's Palsy was unknown. The reporter did not provide an assessment for the event, Bell's Palsy.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Yes,U,02/09/2021,02/09/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Facial paralysis'],1,MODERNA,OT 1045546,IL,,F,"diarrhea; chills; headache; she had no use of the right arm; extreme pain down my arm (right), pain was like a stabbing with knife on my arm; extreme pain up my jaw (right side); extreme pain in back (right side); didn't sleep much at all; her arm was sore by 2pm and felt really weak by the )time evening came; felt really weak; arm was sore; Neck pain; A spontaneous report was received from a 72-year-old female patient, who experienced sore arm, felt weak, extreme pain in right arm, right jaw and back, and neck, did not sleep much at all, pain was like stabbing with knife on arm, no use of right arm, diarrhea, and chills. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) on 05 Feb 2021 at 10:45 AM in right arm for the prophylaxis of COVID-19 infection. On 05 Feb 2021 at 2:00 PM, her arm was sore, felt really week by the evening, extreme pain down her arm, up my jaw, neck and back, did not sleep much. She took acetaminophen which dulled the pain. On 06 Feb 2021, pain was like a ""stabbing with knife on arm."" She stated that the pain was worse at night and she had no se of the right arm. On 07 Feb 2021, she had diarrhea, chills, and headache. On 08 Feb 2021, she had no pain in neck and jaw, and her arm was still mildly sore, had dull headache. Treatment included acetaminophen. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events, sore arm, felt weak, extreme pain in right arm, and back was not resolved; outcome of the events, extreme pain in jaw, back, neck was resolved on 08 Feb 2021; outcome of the events, did not sleep much, pain was like a ""stabbing with knife on my arm"", no use of right arm, diarrhea, chills, and headache was not resolved.; Reporter's Comments: This case concerns a 72-year-old female with a serious unexpected event of LLT Paralysis arm with NS unexpected arm pain, jaw pain, neck pain, back pain, asthenia, diarrhea, difficulty sleeping and NS expected vaccination site pain, headache, chills. The events occurred 2 days after the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,01/05/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Asthenia', 'Back pain', 'Chills', 'Diarrhoea', 'Headache', 'Insomnia', 'Monoplegia', 'Muscular weakness', 'Neck pain', 'Pain in extremity', 'Pain in jaw', 'Vaccination site pain']",1,MODERNA,OT 1045547,NJ,,F,"Fell; Blurred vision; Very weak; Passed out; A lot of pain; Chills; A spontaneous report was received from a 66-year- old female patient who experienced a lot of pain, chills, fell, blurred vision, very weak and passed out. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 039K20A) on 08 Feb 2021, intramuscularly in left arm for the prophylaxis of COVID-19 infection. On 08 Feb 2021, the patient experienced pain at injection site, chills. On 09 Feb 2021, the patient fell, had blurred vision, very weak and passed out. She spoke to her doctor who recommended rest. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event passed out was resolved; outcome of the events, pain at injection site, chills, fell, blurred vision, and very weak, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Asthenia', 'Chills', 'Fall', 'Loss of consciousness', 'Pain', 'Vision blurred']",1,MODERNA,OT 1045548,CA,87.0,F,"blood clot in the lungs; UTI; COVID-19; Fatigue; Loss of appetite; A spontaneous report was received from a consumer concerning an 87 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot in the lungs/MedDRA PT: pulmonary embolism, loss of appetite/MedDRA PT: appetite lost, UTI/MedDRA PT: urinary tract infection, COVID-19/MedDRA PT: COVID-19, and fatigue/MedDRA PT: fatigue. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first dose of two planned doses of mRNA-1273 (Lot# 041L20A) in left arm (route of administration not provided) on 16 Jan 2021 for prophylaxis of COVID-19 infection. On 17 Jan 2021, the patient experienced fatigue and loss of appetite. On 24 Jan 2021, patient experienced UTI and tested positive for COVID-19. On 31 Jan 2021, the patient was hospitalized and was found to have a blood clot in the lungs. Treatment details were unknown. Action taken with mRNA-1273 was unknown. The outcome of events blood clot in the lungs, loss of appetite, UTI and COVID-19 were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/16/2021,01/17/2021,1.0,UNK,,No adverse event (No medical history reported),,,,"['COVID-19', 'Decreased appetite', 'Fatigue', 'Pulmonary embolism', 'SARS-CoV-2 test', 'Urinary tract infection']",1,MODERNA,OT 1045549,CA,50.0,F,"Hypersensitivity reaction; Mild metallic taste; Flushing; Heart palpitations; Tightness in chest; Lightheadedness; Weakness; A spontaneous report was received from a consumer who is a physician concerning herself, a 50 year old female patient who recived Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypersensitivity reaction, dysgeusia, flushing, palpitations, chest discomfort, dizziness and asthenia. The patient's medical history was not provided. No relevant concomitant medication was reported. On 26Dec2020, the patient received the first of their first of two planned doses of mRNA-1273 (lot number 025H20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26Dec2020, shortly after receiving the injection, the patient experienced a hypersensitivity reaction with a mild metallic taste, flushing heart palpitations, tightness in chest, lightheadedness, and weakness. No treatment was reported and the symptoms did not last past the day. Action taken with the mRNA-1273 in response to the events was not reported. The outcome of the events of hypersensitivity reaction, dysgeusia, flushing, palpitations, chest discomfort, dizziness and asthenia was considered resolved.; Reporter's Comments: This case concerns a 50 year old, female patient, who experienced a serious unexpected event of Hypersensitivity after receiving first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/26/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Asthenia', 'Chest discomfort', 'Dizziness', 'Dysgeusia', 'Flushing', 'Hypersensitivity', 'Palpitations']",1,MODERNA,OT 1045550,MA,,F,"Anaphylactic Shock; rapid heart rate; injection site redness; injection site soreness; body ache; troble swallowing; diarrhea; A Spontaneous report was received from a consumer concerning a 40- year-old , female patient, who received Moderna's COVID-19 vaccine (mRNA)and experienced Anaphylatic shock, diarrhea, injection site soreness and redness. The patient's medical history was not provided and allergies included allergic to latex. No concomitant medication was reported. On 21 Jan 2021, approximately 25 minutes prior to the onset of events, the patient received their first of two planned dose of mRNA-1273(lot number-012L20A) intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2021, prior to receiving mRNA-1273, after 25 minutes the patient experienced anaphylactic shock and the symptoms during shock include rapid heart rate, trouble swallowing and passing out. The patient was rushed to hospital and was intervened with Epinephrine and Benadryl. The action taken with mRNA-1273 in response to the events was unknown. The events anaphylactic shock, body ache , diarrhea, injection site soreness and redness are not resolved.; Reporter's Comments: This report concerns a 40--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273) (Lot #012L20A) and experienced anaphylactic shock, diarrhea, injection site soreness and redness. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/21/2021,0.0,UNK,,Allergy (allergic to latex),,,,"['Anaphylactic shock', 'Diarrhoea', 'Dysphagia', 'Heart rate increased', 'Injection site erythema', 'Injection site pain', 'Pain']",1,MODERNA,OT 1045551,DE,65.0,F,"severe headache; blurriness; liquid behind her cornea; 2 leaks in the eye; extended artery in left side of head; hearing loss in left ear; arm pain; A spontaneous report received from a Consumer concerning, 65-year-old female patient who has received both doses of the Moderna COVID-19 vaccine and experiencing arm pain, sever headache, blurriness, liquid behind her cornea, 2 leaks in the eye, extended artery in left side of head and hearing loss in her left ear/MedDRA PT: [Sever Headache]. The patient's medical history was not included/ unknown. Patient's concomitant was not included/ unknown. On 10-FEB-2021, the patient received their second of two planned doses of mRNA-1273 (Batch #: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. On 11-FEB-2021 Patient Husband reported, that his wife received the Moderna COVID-19 vaccine on 14JAN2021 in her left arm and on the same day experienced arm pain that lasted for 3 days. On 16JAN2021 the patient reported that she had a severe headache and shortly after experienced blurriness. The patient got medical attention and it was reported that she has liquid behind her cornea and 2 leaks in the eye, extended artery in left side of head and hearing loss in her left ear. Symptoms are ongoing and HCP consent was obtained. Patient was not hospitalized. Treatment information was not provided/ unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was unknown/not reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Arterial disorder', 'Corneal oedema', 'Eye disorder', 'Headache', 'Pain in extremity', 'Sudden hearing loss', 'Vision blurred']",2,MODERNA,OT 1045552,OH,,F,"Vaccine dripped out while the pharmacist was injecting her arm, did not get the full dose; A spontaneous report was received from a consumer, concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and did not get the full dose, some of the vaccine dripped out while the pharmacist was injecting her arm, and about ninety percent of the vaccine got into arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On an unknown date, the patient reported that she did not get the full dose of the vaccine when she received her first shot. She also reported that some of the vaccine dripped out, while the pharmacist was injecting her arm. The patient is not sure how much dripped out but reports about ninety percent of the vaccine got into arm. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, did not get the full dose, some of the vaccine dripped out while the pharmacist was injecting her arm, and about ninety percent of the vaccine got into arm were resolved.; Reporter's Comments: This report refers to a case of underdose for mRNA-1273. There were no reported AEs associated with this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No patient medical history reported.),,,['Underdose'],1,MODERNA,OT 1045553,GA,73.0,F,"Facial drooping; blurred vision; A spontaneous report was received from a healthcare professional concerning a 73 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed facial drooping/facial paralysis and blurred vision/vision blurred. The patient's medical history included hypertension. Products known to have been used by the patient, within two weeks prior to the event, included diltiazem, metoprolol, HCTZ, calcium, and multivitamin. On 25 Jan 2021, approximately two weeks prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 013L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. The patient began experienced facial drooping with blurred vision on 09 Feb 2021. The patient presented to the hospital and was treated with prednisone and acyclovir. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events facial drooping with blurred vision were not recovered. Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/09/2021,15.0,UNK,DILTIAZEM; METOPROLOL; HCTZ; CALCIUM; MULTIVITAMINS;MINERALS,Hypertension,,,,"['Facial paralysis', 'Vision blurred']",1,MODERNA,OT 1045554,SC,72.0,F,"temperature has been dropping today over the last 30 minutes and is now at 91.2 degrees; Diarrhea; A spontaneous report was received from a consumer concerning a 72-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced temperature dropping and diarrhea. The patient's medical history was not provided. Concomitant medications known to have been used by the patient included amlodipine, losartan, apixaban, and docusate sodium. On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029K20A) for prophylaxis of COVID-19 infection. On 12 Feb 2021, the patient temperature had been dropping over the last 30 minutes and was at 91.2 degrees and she experienced diarrhea. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the events were resolved on 12 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/12/2021,2.0,UNK,AMLODIPINE; LOSARTAN; ELIQUIS; COLACE; FERROUS [IRON],,Medical History/Concurrent Conditions: No adverse event (No reported Medical History),,,"['Body temperature', 'Diarrhoea', 'Hypothermia']",1,MODERNA,OT 1045555,NJ,,M,"Not sure any liquid administered; A spontaneous report was received from a consumer regarding himself, a 75-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced possible vaccine underdose. The patient's medical history was not provided. Products known to have been used by the patient were not included. On 05 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 016M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 05 Feb 2021, as the patient received the vaccine, he noted that the nurse was fiddling with the vial for a long time. Patient stated that on the news it was said to go quicker, like 2 seconds and it took at least 10 seconds for this dose. Patient reported that the skin was punctured but is unsure if any liquid was administered. Patient reports always having a vaccine reaction and this time there was none. Due to the patient having zero side effects, they assume that they did not receive the vaccination. Treatment information was not provided. Action taken with mRNA-1273 was not provided. The outcome of the events, vaccine underdose, was considered resolved.; Reporter's Comments: This report refers to a case of Vaccine underdose for mRNA-1273, lot 016M20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported past medical history.),,,['Underdose'],1,MODERNA,OT 1045556,CA,77.0,M,"Did not get the full dose; Syringe and needles did not connect correctly; A spontaneous report was received from a nurse, concerning a male patient of unknown age, who experienced a medication error where he did not get the full dose/MedDRA PT: underdose, and syringe and needles did not connect correctly/MedDRA PT: device connection issue. The patient's medical history was not provided. No concomitant medications were reported. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly for prophylaxis of COVID-19 infection. Nurse reported that the equipment came in from the state and some of the syringes and needles did not connect correctly. The patient did not get the full dose because where the syringe and needles did not connect right and during administration, the majority of the vaccine came out of the connection and not into the patient's muscle. No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the event was not reported. The event, medication error of underdose and device connection issue, was considered as resolved. The nurse reported the same event for two different patients so an additional case created for each of the 2 separate reports, one for each patient.; Reporter's Comments: This case concerns a 77-year-old male who experienced NS unexpected events of Incomplete dose administered and Device connection issue without associated adverse events. The events occurred the same day as the first dose of mRNA-1273 (lot # unknown). Events resolved. Further information requested.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-014294:same reporter, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Device connection issue', 'Incorrect dose administered']",1,MODERNA,OT 1045557,CA,17.0,F,"Administered first dose of the Moderna Covid-19 to a 17 year old patient.; Dizziness; A spontaneous report was received from a healthcare provider (HCP) concerning a 17-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness and inappropriate age at vaccine administration. The patient's medical history was not provided. Concomitant medications were not provided. On 21 JAN 2021, the patient received her first of two doses of mRNA-1273 (lot number 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The HCP reported that in order to not waste any doses, the facility calls on family and friends to get the vaccine for no shows. The HCP reported that the patient experienced dizziness a few minutes after the injection. The patient hadn't eaten for 16 hours prior to taking the shot. The patient was monitored, and it resolved within the hour. Treatment for this event was not reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, dizziness and inappropriate age at vaccine administration was recovered.; Reporter's Comments: This case report concerns a 17-year-old female patient who was administered mRNA-1273 vaccine Lot# 042L20A (inappropriate age at vaccine administration) and experienced dizziness. The event of dizziness is temporarily associated with the product use and a causal association cannot be excluded. The event of inappropriate age at vaccine administration is assessed as not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No adverse event history),,,"['Dizziness', 'Product administered to patient of inappropriate age']",1,MODERNA,OT 1045558,CA,,M,"Majority of the vaccine came out of the connection; Did not get the full dose; A spontaneous report was received from a healthcare professional concerning a 77-year-old, male patient who received a first dose of Moderna's COVID-19 vaccine, and some of the syringes and needles did not connect correctly, patient might have not gotten the full dose. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) Intramuscularly for prophylaxis of COVID-19 infection. On 22-Jan-2021, reporter HCP (RN) stated that equipment for vaccination came from the state, and some of the syringes and needles did not connect correctly and due to that during administration, in two different patients, the majority of the vaccine came out of the connection and not into the patient's muscle. Reporter was concerned about that two patients might not gotten the full dose, and should they continue schedule and consider the vaccine legitimate or should they restart the series after 28 days. No treatment information was provided. Action taken with the mRNA-1273 in response to the event was not reported. The events, some of the syringes and needles did not connect correctly, patient might have not gotten the full dose were considered recovered/resolved.; Reporter's Comments: This report refers to a case of device connection issue and underdose for mRNA-1273, lot # unknown, with no associated AEs; Sender's Comments: MOD-2021-014288:same reporter, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Device connection issue', 'Underdose']",1,MODERNA,OT 1045559,,16.0,U,"16 yo accidentally given Moderna vaccine; A spontaneous report was received from a healthcare professional concerning a 16 year old who received Moderna's COVID-19 Vaccine (mRNA-1273) and a 16 year old was accidentally given the Moderna vaccine/product administered to patient of inappropriate age. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 29 Jan 2021, the physician called to report that a 16 year old patient was accidentally given the Moderna vaccine. The patient was ""clinically fine"". No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, 16 year old was accidentally given the Moderna vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273. There was no associated AEs with this case of inappropriate age at vaccine administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1045560,WA,,F,"During injection the needle broke; Felt the vaccine leaking on her arm; A spontaneous report was received from a consumer regarding her mother, a 67-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced that the needle broke during injection, and felt the vaccine leak down her arm. The patient's medical history was not provided. Concomitant product use was not provided. On 19 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection. On 19 Jan 2021, when the patient was receiving her first dose, the needle was broken and felt like some of the vaccine leaked down her arm. Treatment information was not provided. Action taken with mRNA-1273 in response to events were not reported. The outcome of the events, during injection the needle broke and felt the vaccine leaking on her arm were considered resolved on 19 Jan 2021.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273. There were no reported adverse events associated with this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse reaction (Medical history not provided),,,"['Device connection issue', 'Underdose']",1,MODERNA,OT 1045561,CT,,F,"sore arm; tired; Rash; Headache for a couple days after the overdose; Felt chilled; patient received ""0.3 ml of the undiluted vaccine""; patient received ""0.3 ml of the undiluted vaccine""/vaccine was undiluted; This is a spontaneous report from a contactable pharmacist and other healthcare professional via a Pfizer-sponsored program. An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL324, expiration date: Apr2021), intramuscular in the left arm, on an unspecified date, at 0.3 mL, single for COVID-19 immunization, at the nursing home. Medical history included high blood pressure, rheumatoid arthritis w/ wrist problems, high cholesterol, cataract surgery 7 years ago (2014), colonoscopy and mammogram regularly (unknown results), allergies to sulfa and iodine and arthritis. Concomitant medications included paracetamol (TYLENOL) for arthritis, losartan, nebivolol hydrochloride (BYSTOLIC), atorvastatin, omeprazole, acetylsalicylic acid (ASPIRIN) and nitrofurantoin (NITRO). Historical vaccine included a flu shot received in October (year not provided) for immunization with no adverse event. The pharmacist reported the inadvertent administration of the COVID-19 vaccine to the patient, by a nurse. She stated that the patient received ""0.3 ml of the undiluted vaccine"" (Failed to ask if it was the patient's first or second dose). The pharmacist asked for recommendations to monitor the patient post-injection. The patient was given 5 times the normal dose (one undiluted vial), vaccine was undiluted. The reporter said that the pharmacy had given 5 times normal dose of the COVID vaccine, undiluted, and reporter wanted to know what was suggested that they do. On 03Feb2021, the pharmacist reported that she was mixing the vials for administration. She stepped away and a nurse pulled an undiluted vial and gave patient 1 dose from undiluted vial with purple top still on. The pharmacist confirmed that the patient received 0.3 mL of undiluted vaccine, not the full vial. The patient's doctor was also there when it happened, and they both stayed with her for about 3 hours after it happened to monitor the patient. The patient had sore arm and felt tired on an unspecified date. Most of her friends felt the same way after getting the Covid vaccine. No other adverse event experienced since then. The pharmacist called to check on her a few times since the overdose and also called Pfizer to ask if the patient should get second dose. On 04Feb2021, it was reported that on an unspecified date, the patient experienced rash, headache for a couple days after the overdose and felt chilled but took Tylenol and was OK after that. The patient recovered from the events rash, headache for a couple days after the overdose and felt chilled on an unspecified date. The outcome of sore arm and fatigue was unknown. No follow up attempts are possible. No further information is expected. Follow-up (02Feb2021 and 03Feb2021): This is a follow-up report combining information from duplicate reports 2021032250 and 2021029952. The current and all subsequent information will be reported under manufacturer report number 2021029952. Additionally, new information was received from the same contactable pharmacist includes: suspect drug details (vaccination route and site, vaccination facility type) and event details (new events sore arm and fatigue). Information on the batch number and lot number has been requested. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities. Additional information received on 04Feb2021 from the same contactable pharmacist includes: medical history (high blood pressure, rheumatoid arthritis, high cholesterol, cataract surgery, colonoscopy, mammogram, allergy to sulfa and iodine, arthritis), historical vaccine, concomitant medications (losartan, Bystolic, atorvastatin, omeprazole, Aspirin, Nitro) and new events (rash, headache and chills). Information on the lot/batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,SEN,TYLENOL; LOSARTAN; BYSTOLIC; ATORVASTATIN; OMEPRAZOLE; ASPIRIN [ACETYLSALICYLIC ACID]; NITRO [NITROFURANTOIN],Cataract operation,Medical History/Concurrent Conditions: Arthritis; Blood cholesterol abnormal; Blood pressure abnormal; Cataract; Colonoscopy (~~~); Iodine allergy; Mammogram; Rheumatoid arthritis; Sulfonamide allergy,,,"['Chills', 'Colonoscopy', 'Fatigue', 'Headache', 'Mammogram', 'Overdose', 'Product preparation error', 'Rash', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 1045562,IL,48.0,F,"arm very painful; swollen and tender left axillary and left supraclavicular nodes; swollen and tender left axillary and left supraclavicular nodes; chills; red x 5 days; This is a spontaneous report from a contactable healthcare professional (patient). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249; dose 2) via an unspecified route of administration on 20Jan2021 at 1:30 PM (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included hypertension and mild asthma. The patient was not pregnant at the time of vaccination. It was unknown if the patient had COVID-19 prior to vaccination. The patient took concomitant medications which were unspecified. The patient did not received any other vaccines within four weeks prior to the vaccination. The patient previously took penicillin on unknown dates for an unknown indication and experienced allergy. The patient received dose 1 of BNT162B2 (lot number: EL0104) on 30Dec2020 at 11:30 AM in the left arm as a single dose for COVID-19 immunization. On an unspecified date after the second vaccination, the patient had arm very painful, red for 5 days, and swollen and tender left axillary and left supraclavicular nodes. On 21Jan2021, 24 hours after the vaccine, the patient experienced chills lasting three to four hours. The patient did not have adverse effects at all after the first vaccine. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The outcomes of arm very painful and red, swollen and tender left axillary and left supraclavicular nodes, and chills were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,,,PUB,,,Medical History/Concurrent Conditions: Asthma; Hypertension; Penicillin allergy (Known allergies: penicillin),,,"['Chills', 'Erythema', 'Lymph node pain', 'Lymphadenopathy', 'Pain in extremity']",2,PFIZER\BIONTECH, 1045563,NY,28.0,F,"Supper fatigued; chills; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for herself. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at Left arm on 25Jan2021 18:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included allergies: Seafood. Concomitant medication included spironolactone. The patient's historic vaccine included first dose of BNT162B2 received on an unknown date for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. The patient experienced supper fatigued and chills on 26Jan2021 10:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on Jan2021. Information on lot number/batch number requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/26/2021,1.0,PVT,SPIRONOLACTONE,,Medical History/Concurrent Conditions: Seafood allergy,,,"['Chills', 'Fatigue']",2,PFIZER\BIONTECH,OT 1045564,MI,31.0,F,"I woke up the next day with a bad headache; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration at left arm on 25Jan2021 15:45 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. No allergies to medications, food or other products. The patient's concomitant medication included Multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient woke up the next day with a bad headache. The event started on 26Jan2021 at 08:00. There was no treatment received for the adverse event. The event was non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient recovered from the event in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/26/2021,1.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Headache'],1,PFIZER\BIONTECH, 1045565,MO,65.0,M,"I had an oral sensation like I was tasting something cold.; This is a spontaneous report from a consumer. A 65-year-old male patient received first dose bnt162b2 (COVID 19, Pfizer, EN 5318), via an unspecified route of administration, Left arm on 27Jan2021 15:15 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine was administered in four weeks. On 27Jan2021 at 16:15, approx. an hour after injection, the patient had an oral sensation like he was tasting something cold. No treatment was given for the event. Outcome of event was recovered on 2021. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,UNK,,,,,,['Oral discomfort'],1,PFIZER\BIONTECH, 1045566,OH,61.0,F,"metallic taste in mouth; metallic taste in mouth; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EK4176), via an unspecified route of administration on 19Jan2021 at single dose at right arm for covid-19 immunization. Medical history included T1DM (Type I diabetes mellitus) from 1974, AVR (aortic valve replacement) from 1990 (AVR 1990 and 1992). No known allergies. Concomitant medications included insulin, simvastatin, lisinopril. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Patient previously received first dose of bnt162b2 (lot number= EK5730) via an unspecified route of administration on 29Dec2020 11:00 AM at single dose at right arm for covid-19 immunization, and had metallic taste in mouth on 31Dec2020 for 3 days, chronic nausea began 07Jan2021, vomiting was explosive and unpredictable, and still occurring, splitting headaches. The patient experienced metallic taste in mouth on 19Jan (pending clarification) with outcome of not recovered. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive any treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,UNK,INSULIN; SIMVASTATIN; LISINOPRIL,,Medical History/Concurrent Conditions: Aortic valve replacement (AVR 1990 and 1992); Type I diabetes mellitus,,,"['Disease recurrence', 'Dysgeusia']",2,PFIZER\BIONTECH, 1045567,FL,,U,"On day 19 after the vaccine was given I tested them for antibodies to the virus, they both were negative for IgM and IgG.; This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is 2nd of 2 reports. A 78-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician reported that the couple was vaccinated on the same day in the same vehicle at a drive-through vaccination site. Both patients had no symptoms after the vaccination. On 17Jan2021, on day 19 after the vaccine was given, the patient was tested for antibodies to the virus, and both were negative for IgM and IgG; the control was positive. The test was negative for both IgM and IgG for both patients. The physician was asking if the first shot was not given properly and if they need a third vaccination. The physician was concerned that there may be an issue with the sensitivity of the office test. All of their friends have had at least some arm discomfort after the vaccine, they were nervous about the vaccine not working. Outcome of event was unknown. Information on lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021063846 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,01/17/2021,19.0,UNK,,,,,,"['Antibody test abnormal', 'SARS-CoV-2 antibody test']",1,PFIZER\BIONTECH, 1045568,,,F,"migraine; This is a spontaneous report based on the information received by Pfizer from (Allergan Medical Information Request: US21-002211). A contactable consumer (patient) reported this female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Jan2021 as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included ubrogepant (UBRELVY) from 13Jan2021 for headache-migraine. The patient experienced migraine on 23Jan2021 in the morning. The patient took a ubrogepant dose on 23Jan2021 and it relieved the pain. She was fine. On 25Jan2021 the patient had a severe migraine so she had to take another dose of ubrogepant. The patient stated that the migraines had been different since she received the vaccine. The patient wanted to know if there were any potential reactions between ubrogepant and BNT162B2, if it was safe to take ubrogepant in patients who have received BNT162B2, and if rebound headache was a reported side effect of ubrogepant. The outcome of migraines was not recovered. No follow-up attempts are possible; information about lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/23/2021,10.0,UNK,,,,,,['Migraine'],UNK,UNKNOWN MANUFACTURER, 1045569,NJ,59.0,M,"chills and felt feverish; chills and felt feverish; This is a spontaneous report from a non-contactable consumer. A 59-year-old male patient (reporter's husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264) via an unspecified route of administration in left arm on 28Jan2021 at 08:30 at single dose for COVID-19 immunization. Medical history included high blood pressure and diabetes. Patient has no allergies to medications, food, or other products. Concomitant medications included amlodipine besilate, atorvastatin calcium (CADUET) and escitalopram oxalate (LEXAPRO), both received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 29Jan2021 at 14:00, the day after the shot, which was the 1st shot, reporter's husband had chills and felt feverish. He took 2 ADVIL then he felt fine. No treatment and no seriousness criteria was reported. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovered on 29Jan2021. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/29/2021,1.0,UNK,CADUET; LEXAPRO,,Medical History/Concurrent Conditions: Blood pressure high; Diabetes,,,"['Chills', 'Pyrexia']",1,PFIZER\BIONTECH, 1045570,PA,24.0,F,"unusual and extreme tiredness; rash on the face; This is a spontaneous report from a non-contactable consumer. A 24-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number was not reported), via an unspecified route of administration on 28Jan2021 (dose number=2) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. On 28Jan2021, the patient experienced unusual and extreme tiredness and rash on the face. The seriousness considered as non-serious. It was unknown if patient received any treatment for the adverse events. Since the vaccination, it has been unknown if the patient been tested for COVID-19. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,,,,,,"['Fatigue', 'Rash']",2,PFIZER\BIONTECH, 1045571,LA,60.0,M,"Diarrhea; body aches; chills; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262, Expiry date: unknown) via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunisation. Medical history included covid-19 (if covid prior vaccination Yes). The patient's concomitant medications were not reported. The patient experienced diarrhea, body aches and chills on 29Jan2021. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse events. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jan2021. No follow-up attempts needed. No further information expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PVT,,,"Medical History/Concurrent Conditions: COVID-19 (""if covid prior vaccination Yes"")",,,"['Chills', 'Diarrhoea', 'Pain']",UNK,PFIZER\BIONTECH, 1045572,GA,77.0,F,"red rash appeared on chest. Within another 24 hours it moved over entire body...very red; red rash appeared on chest/ very red and extremely itchy; This is a spontaneous report from contactable consumer (patient). A 77-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration on left arm on 23Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included ongoing non- hodgkin lymphoma. Concomitant medication included ursodiol, furosemide, spironolacton, propranolol hydrochloride (PROPRANOL). Approximately 24hours after vaccination a slight fine, red rash appeared on chest. Within another 24 hours it moved over entire body. very red and extremely itchy on 24Jan2021. visited myoncologist and was prescribed Benadryl and cortisone cream for itch. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/24/2021,1.0,UNK,URSODIOL; FUROSEMIDE; SPIRONOLACTON; PROPRANOL,Non-Hodgkin's lymphoma,,,,"['Rash erythematous', 'Rash pruritic']",1,PFIZER\BIONTECH, 1045573,,,F,"Made them feel weird or hurt; Made them feel weird or hurt; This is a spontaneous report received from a contactable consumer (patient) communicated to a Pfizer sales representative. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was not known if the patient was pregnant at time of vaccination. It was not known if the patient received other vaccines within 4 weeks prior to the COVID vaccine. It was not known if the patient was diagnosed with COVID-19 prior to vaccination. The patient experienced feel weird or hurt on an unspecified date. It was unknown if the patient received treatment in response to the event. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Feeling abnormal', 'Pain']",UNK,PFIZER\BIONTECH, 1045574,NJ,50.0,F,"Fever; Body aches; Headache; chills; This is a spontaneous report from a non-contactable consumer (patient) reported that a 50-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on left arm on 22Jan2021 17:00 at single dose for covid-19 immunisation. Medical history reported as none. Concomitant medication included eletriptan hydrobromide (RELPAX), atorvastatin (LIPITOR). The patient previously took first dose of BNT162B2 on 31Dec2020 at 05:00 PM for COVID-19 immunization. On 23Jan2021, patient had fever, body aches, headache and chills. The patient received treatment with TYLENOL. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/23/2021,1.0,PHM,RELPAX; LIPITOR [ATORVASTATIN],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1045575,MI,47.0,F,"sore arm x2 days; This is a spontaneous report from a contactable consumer (patient). A 47-year-female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 20Jan2021 16:15 (lot number: el3248), via an unspecified route of administration in the right arm at single dose for COVID-19 immunization in the workplace clinic. The patient's medical history was not reported. The patient's concomitant medication included hydrochlorothiazide, quinapril hydrochloride (ACCURETIC). The patient did not receive other vaccines within four weeks. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested after the vaccination for COVID-19. The patient experienced sore arm x2 days on 21Jan2021 at 07:00 AM. The patient did not received treatment. The consumer assessed the event as non-serious. The outcome of the event was recovered in 23Jan2021. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/21/2021,1.0,WRK,ACCURETIC,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1045576,MI,50.0,F,"sore arm; other vaccine same date vaccine date: 01Feb2021; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose on 01Feb2021 15:15 (lot number: EL3248), via an unspecified route of administration in the right arm at single dose for COVID-19 immunization in the workplace clinic. The patient's medical history includes ulcerative colitis, shellfish allergy, sulfa allergies unknown if ongoing from an unknown date. The patients historical drug included benzthiazide (REGULON) which caused allergies. Patient received the first dose of BNT162B2 (lot number: EL3248) on 13Jan2021 14:15 in the left arm for COVID-19 immunization. Concomitant medications included tofacitinib citrate (XELJANZ) and cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D). The patient was administered with other vaccine on same day i.e. 01Feb2021. However, it was also reported that the patient did not receive any other vaccine within four weeks. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. The patient experienced sore arm on 02Feb2021 05:00 AM. The patient did not received treatment. The consumer assessed the events as non-serious. The outcome of the sore arm was recovered in Feb2021. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,WRK,XELJANZ; ZYRTEC-D,,Medical History/Concurrent Conditions: Shellfish allergy; Sulfonamide allergy (Allergies :Sulfa); Ulcerative colitis,,,"['Pain in extremity', 'Product use issue']",2,PFIZER\BIONTECH, 1045577,MI,72.0,F,"the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredness; headache; Muscle pain; joint pain/joint pain in her knees; hot flashes to where she would nearly pass out a couple of times; hot flashes to where she would nearly pass out a couple of times; nausea; face and everything was red; Dizzy; weak; chills; Feeling unwell; I had difficulty breathing; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on her right arm, via an unspecified route of administration on 26Jan2021 15:30 at SINGLE DOSE for covid-19 immunization. Medical history included multiple myeloma, Kidney failure, dialysis; all on Aug2020 and ongoing and cancer. The patient's concomitant medications were not reported. The patient previously took an unspecified flu shot for swine flu but had a terrible reaction (allergies). It was reported by the patient had injection site pain in her right arm the next day after vaccination. Stated that she had tiredness, headache, muscle pain, joint pain in knees, hot flashes to where she would nearly pass out a couple of times, nausea that was very bad for two days. Stated that her face and everything was red, dizzy and weak and had chills. Stated that it has been eight days since she can do that. Stated that she took Extra Strength Tylenol for headache. The patient also stated that she was feeling unwell, that started on the 27th until today. She also had difficulty breathing that has lasted 8 days, the swelling of her face and throat on the 31Jan2021 for one day. The outcome of the event tiredness was recovering, unknown for events chills, feeling unwell, difficulty breathing and swelling face, while recovered for the other events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,UNK,,Dialysis; Kidney failure; Multiple myeloma,Medical History/Concurrent Conditions: Cancer,,,"['Arthralgia', 'Asthenia', 'Chills', 'Dizziness', 'Dyspnoea', 'Erythema', 'Fatigue', 'Headache', 'Hot flush', 'Malaise', 'Myalgia', 'Nausea', 'Pharyngeal swelling', 'Presyncope', 'Swelling face', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1045578,,71.0,F,"severe muscle and joint pain; severe muscle and joint pain; fever 100�F; dizziness; severe headache; no Appetite; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EI9262), via an unspecified route of administration on 24Jan2021 at 14:00 on the left arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination and had no known allergies. The patient previously received the first dose of BNT162B2 (lot number: EH9899) on 03Jan2021 on the left arm for COVID-19 immunization. It was reported that on 25Jan2021, the next day after the vaccination, the patient woke up with severe muscle and joint pain, fever 100�F, dizziness, severe headache and no appetite. The patient took 2 Tylenol and it got better. Six hours later she took another 2 Tylenol because the headache came back; slept a couple of times a day and had a good night's sleep. Next day, she was a little better but still in bed, she fed myself better. The next day she went to the doctor (prior appointment) and was prescribed Meloxicam and Tylenol 6 hours after and was getting better. The outcome of the events was recovered. Post vaccination, the patient has not been tested for COVID.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/24/2021,01/25/2021,1.0,PUB,,,,,,"['Arthralgia', 'Decreased appetite', 'Dizziness', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH, 1045579,IL,,F,"The nurse hit a vein and so the injection site started bleeding; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (mother). A female patient (daughter) of an unspecified age (Age:24, Unit: Unknown) received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 03Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse hit a vein and so the injection site started bleeding. The pharmacist on-site explained to them that the bleeding was caused by the vein and that the vaccine has been given intramuscularly so she must have received the dose. The event outcome was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/03/2021,0.0,UNK,,,,,,['Vaccination site haemorrhage'],1,PFIZER\BIONTECH,OT 1045580,AL,82.0,M,"right hip was very painful, it killed him/ right hip started to kill him/ couldn't walk without his hip giving way from the pain; hardly could walk on it/ couldn't walk without his hip giving way from the pain/didn't have any problem with walking around until he took the vaccine; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264), via an unspecified route of administration (left arm), on 02Feb2021 09:00, at single dose, for covid-19 immunization. Ongoing medical history included cholesterol, GERD, heart, and prostate. Concomitant medication included carvedilol (COREG) from 2011 and ongoing for heart; lovastatin (MEVACOR) from 2011 and ongoing for cholesterol; alfuzosin hydrochloride (UROXATRAL) from 2011 and ongoing for prostate; omeprazole (OMEPRAZOL) from 2016 and ongoing for GERD; torsemide from 2001 and ongoing for water pill for his heart; and sacubitril valsartan sodium hydrate (ENTRESTO) from 2011 and ongoing for heart. The patient took the first dose of the Pfizer vaccine yesterday, 02Feb2021, at 9:00 and at 15:00 his right hip was very painful, it killed him; hardly could walk on it. His right hip started to kill him. He couldn't walk without his hip giving way from the pain. He didn't have any problem with walking around until he took the vaccine. He wanted to know if it was going to go away. The patient had not recovered from the adverse events at the time of the report. The adverse events did not require a visit to a physician or ER. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He was planning to receive the second dose on 23Feb2021 and mentioned that he was having a heart test later this week.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,UNK,COREG; MEVACOR; UROXATRAL; OMEPRAZOL; TORSEMIDE; ENTRESTO,Benign prostatic hyperplasia; Cholesterol; GERD; Heart disorder,,,,"['Arthralgia', 'Gait disturbance']",1,PFIZER\BIONTECH, 1045581,MS,,U,"full body rash/the rash on all over their body; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 4 patients (resident of a long term facility and are above 65 years of age). This is 1st of 4 reports. A elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The Pharmacist reported 4 patients who experienced Full body rash/the rash on all over their body after getting pfizer covid vaccine on an unspecified date, It happened 2-3 days after the vaccine. The event outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021113120 Same reporter/ drug/ event for different patients.;US-PFIZER INC-2021113121 Same reporter/ drug/ event for different patients.;US-PFIZER INC-2021113122 Same reporter/ drug/ event for different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Rash'],UNK,PFIZER\BIONTECH, 1045582,NC,,F,"Mild vasovagal reaction; Itching; Rash at injection site; This is a spontaneous report from a contactable pharmacist. A 21-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had a mild vasovagal reaction and rash at injection site. She stayed an hour for observation and said she felt fine but by the time she left, had complained of itching all over. The outcome of the event itching all over was unknown while recovered on unspecified dates for the other events. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,,,UNK,,,,,,"['Presyncope', 'Pruritus', 'Vaccination site rash']",1,PFIZER\BIONTECH, 1045583,TX,65.0,F,"my results came back stating I was positive; feel ill with a severe back pain on my left side. The same side where I was given the shot; cough; runny nose; headaches; a lot of pain in my bones; a lot of pain in my bones, and eye lids; Feel ill; This is a spontaneous report from a consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on the left arm on 25Jan2021 at 11:00 at the age of 65 years old at a single dose for COVID-19 immunisation at the school/student Health Clinic. Medical history was none. The patient has no allergies to medications, food and other products. The patient is not pregnant and was not pregnant at the time of vaccination. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 at 07:00, patient began to feel ill with a severe back pain on her left side. The same side where she was given the shot. In addition, patient also experienced a cough, runny nose, headaches, a lot of pain in my bones, and eye lids. At first, she believed it was due to the vaccine but as she got worse, she decided to take a COVID test (nasal swab) on 31Jan2021 and the results came back stating she was positive. Since then the patient has been in quarantine. No treatment was received in response to the events. The patient was recovering from the events. The patient has a second vaccination appointment scheduled on 13Feb2021 and would like to know if she will still go as scheduled or will she need to go in a later date. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,SCH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Back pain', 'Bone pain', 'Cough', 'Eyelid pain', 'Headache', 'Malaise', 'Rhinorrhoea', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1045584,PA,69.0,F,"chills; fever; body aches; headache; vomiting; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program, Pfizer First Connect. A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a sngle dose for covid-19 immunization. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. She mentioned that she received the vaccine on Sunday (unknown date) and reported that for the last 4 days she had been pretty sick with fever, chills, headache and body aches. She had been alternating acetaminophen (TYLENOL) and ibuprofen (ADVIL). She did have COVID in Nov2020. The patient inquired if the symptoms after dose 2 would be worse if she's had COVID in the past. She also inquired if she will have the same symptoms for the second dose and if how long side effects will last. She add that she did have some vomiting on Sunday later after she got the vaccine. She was wondering because she is to get the second dose on the 21st, the pharmacist did say that sometimes people who have had the Covid virus already can sometimes experience strong side effects from the vaccine. She does not want to feel or get sick. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Chills', 'Headache', 'Pain', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH, 1045585,AZ,,M,"sore arm/arm pain; ""felt the fire""/felt the burning of it going in; chills and heat/little chills; chills and heat/little heat; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age (reported as 85, unit not provided, pending clarification) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included flu vaccine received on an unspecified date and the patient got really sick, got really sick with the flu, was like got the flu but in 2 hours. The patient received BNT162B2 vaccine and experienced sore arm on an unspecified date. He ""felt the fire"", experienced chills and heat on an unspecified date and then the next day he was fine. He stated that after the first shot, he had arm pain for a couple of days, felt the burning of it going in and a little heat and little chills but the next day he was on the way to being good. The patient recovered from the event sore arm/arm pain and was recovering from the events ""felt the fire""/felt the burning of it going in, chills and heat/little chills and chills and heat/little heat. The reporter assessed the events as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Chills', 'Feeling hot', 'Pain in extremity', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1045586,FL,74.0,M,"First Covid-19 Vaccine: flu-like symptoms; First Covid-19 Vaccine: whole left arm muscle was sore; First Covid-19 Vaccine: joint in his elbow was like somebody had a knife sticking in it; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EH9899, first dose) solution for injection intramuscular in the left arm on 28Dec2020 at 08:15 (at the age of 74-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing severe COPD (chronic obstructive pulmonary disease) from 2014 and ongoing idiopathic pulmonary fibrosis from 2020. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020, after the first Covid-19 vaccine, the patient experienced flu-like symptoms, whole left arm muscle was sore and joint in his elbow was like somebody had a knife sticking in it. There was no emergency room or physician office for the events flu-like symptoms, muscle soreness and joint pain. Treatment for the events muscle soreness and joint pain included acetaminophen (TYLENOL). The outcome of the event flu-like symptoms was recovered in Jan2021, after about 3 days. The outcome of the events muscle soreness and joint pain was recovered in Dec2020, after about 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/29/2020,1.0,UNK,,COPD (Verbatim: Severe COPD); Idiopathic pulmonary fibrosis (Verbatim: Idiopathic pulmonary fibrosis),,,,"['Arthralgia', 'Influenza like illness', 'Myalgia']",1,PFIZER\BIONTECH,OT 1045587,OH,65.0,F,"sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread through her body/ twitching, burning, cramping, and tingling; she was up all night and couldn't sleep/ restless, had trouble getting sleep, had trouble getting in a comfortable position/ woke up frequently; restless, had trouble getting sleep, had trouble getting in a comfortable position, and woke up frequently.; tightness in her left leg; weird sensations in her legs/ sensations moved to her arms; Ongoing Restasis for Sjogren's syndrome; Ongoing Restasis for Sjogren's syndrome; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: L9261) via an unspecified route of administration on the left arm on 27Jan2021 14:30 at a single dose for COVID-19 immunization. Medical history included ongoing Sjogren's syndrome from 2015 (sees her Rheumatologist/ do blood work once a year to make sure her inflammation levels are okay), ongoing rosacea; dry eye syndrome (related to Sjogren's syndrome); spasming, burning and twitching (last 2 medications she was on in November and January she had similar type reactions in her muscles); arthritis flareup from Oct2019 (in her left leg, she saw her neurologist who did tests and they came back normal) and sinus infection in 2020. Ongoing concomitant medication included ciclosporin (RESTASIS) for Sjogren's syndrome, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) for blood test: deficient and ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION) for dry eye syndrome related to Sjogren's syndrome. The patient previously took prednisone from Nov2020 and experienced weirdness in her legs got strong enough to keep her up at night and bad flare up for her leg symptoms; metronidazole for flare up or Rosacea (0.75% as needed, which she has used daily for last few weeks), meloxicam in Nov2020 and pantoprazole in Jan2021 and had bad flare up for her leg symptoms (symptoms subsided as soon as she stopped taking the medication after about 5 days); ibuprofen, acetaminophen and pepcid for her stomach. She had the vaccine, her first dose, on 27Jan2021, about a week ago. The first two days she didn't notice anything and then she had weird sensations in her legs on 28Jan2021. The second night she had a weird sensation in her legs which was similar to what she had experienced with the two medications she took in November and January. On 30Jan2021 the sensations spread through her body, she describes these sensations as twitching, burning, cramping, and tingling. She clarifies the sensations moved to her arms which did not happen with the other medications that she tried in November and January. Monday night, 01Feb2021, she was up all night and couldn't sleep and says she called the family doctor yesterday and he called in a prescription for Gabapentin 100 mg. She said she took the medication last night and she did sleep last night, but she was unsure if it was from exhaustion from the last few nights from not sleeping or the medicine, but she did sleep better and her symptoms were a lot less last night. Patient said she wanted to report this and that her concern is with the second dose; will she have a worse reaction, is there anything she can do or take and should she be concerned about it. She said the events gradually increased, they started mildly and then became significant. She felt the sensations a little bit in the day time but they start big time in the night when laying down. These sensations experienced in her legs started the second night, 28Jan2021, and then spread to her arms in the last couple of days which had not happened with her other incidences (with the medications mentioned above back in November and January). Clarified that the sensations spread to her arms on 29Jan2021, but the worst nights were 31Jan2021 and 01Feb2021. She said they were bad nights. She said in regard to her sleeping, starting on 29Jan2021, she was restless, she had trouble getting sleep and trouble getting in a comfortable position. She woke up frequently. Saturday the sleeping was a little worse, but she did sleep. She said on Sunday, 31Jan2021, and Monday, 01Feb2021, she hardly got any sleep. The sensations spread to her arms and it probably started a little on Saturday night, but Sunday and Monday it was very noticeable. She started Gabapentin; it was one a day before bed. The leg symptoms were still there last night. The sensations in her arms were not much at all. She did get up once with the leg cramp and was feeling tightness in her left leg but it never went into a cramp. The cramp was in her right leg, which was unusual because it was usually in her left leg. She stated she was unsure if her symptoms were starting to subside or if the Gabapentin had an immediate effect. The events did not require a visit to physician or ER. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,RESTASIS; VITAMIN D [ERGOCALCIFEROL]; PRESERVISION,Rosacea; Sjogren's syndrome (sees her Rheumatologist/ do blood work once a year to make sure her inflammation levels are okay),"Medical History/Concurrent Conditions: Arthritis flare up (in her left leg, she saw her neurologist who did tests and they came back normal); Burning sensation (last 2 medications she was on in November and January she had similar type reactions in her muscles); Dry eye syndrome (related to Sjogren's syndrome); Sinus infection; Spasms (last 2 medications she was on in November and January she had similar type reactions in her muscles); Twitching (last 2 medications she was on in November and January she had similar type reactions in her muscles)",,,"['Burning sensation', 'Muscle spasms', 'Muscle twitching', 'Musculoskeletal stiffness', 'Off label use', 'Paraesthesia', 'Product use issue', 'Restlessness', 'Sensory disturbance', 'Sleep disorder']",1,PFIZER\BIONTECH, 1045588,MS,,U,"Full body rash/the rash on all over their body; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 4 patients (resident of a long term facility and are above 65 years of age). This is 2nd of 4 reports. A elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The Pharmacist reported 4 patients who experienced Full body rash/the rash on all over their body after getting pfizer covid vaccine on an unspecified date, It happened 2-3 days after the vaccine. The event outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112095 Same reporter/ drug/ event for different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Rash'],UNK,PFIZER\BIONTECH, 1045589,MS,,U,"Full body rash/the rash on all over their body; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 4 patients (resident of a long term facility and are above 65 years of age). This is 3rd of 4 reports. A elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The Pharmacist reported 4 patients who experienced Full body rash/the rash on all over their body after getting pfizer covid vaccine on an unspecified date, It happened 2-3 days after the vaccine. The event outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112095 Same reporter/ drug/ event for different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Rash'],UNK,PFIZER\BIONTECH, 1045590,MS,,U,"Full body rash/the rash on all over their body; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 4 patients (resident of a long term facility and are above 65 years of age). This is 4th of 4 reports. A elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The Pharmacist reported 4 patients who experienced Full body rash/the rash on all over their body after getting pfizer covid vaccine on an unspecified date, It happened 2-3 days after the vaccine. The event outcome was unknown. Information on the lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112095 Same reporter/ drug/ event for different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Rash'],UNK,PFIZER\BIONTECH, 1045591,WI,,F,"chest is hurting; ill/sick; trouble breathing; wasn't able to function; This is a spontaneous report received from a contactable consumer (patient's spouse) via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 30Jan2021 (Saturday morning), the patient woke up and was ill, she had trouble breathing, wasn't able to function and has been sick since. As of 03Feb2021, the patient's chest was hurting a bit less (onset date unspecified) and it was reported that the patient needed to go to the emergency room to know what was going on. The reporter told the patient she should be tested for the virus. The outcome of the events ill/sick, trouble breathing and wasn't able to function was not recovered; and the outcome of chest is hurting was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,01/30/2021,,UNK,,,,,,"['Chest pain', 'Dyspnoea', 'Illness', 'Loss of personal independence in daily activities']",1,PFIZER\BIONTECH, 1045592,NH,74.0,F,"infection in the gum of a tooth that she had pulled; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient had an infection in the gum of a tooth that she had pulled. She was placed on Clindamycin which she has not taken yet. Clinical outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Gingivitis'],UNK,PFIZER\BIONTECH, 1045593,RI,23.0,F,"extreme pain at the injection site; extreme pain at the injection site/could barely lift her arm without having a sharp pain/could barely move it, it felt very heavy; This is a spontaneous report from a contactable consumer. A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EL 3247), via an unspecified route of administration on the left arm on 28Jan2021 10:15 at single dose for covid-19 immunisation. Medical history included asthma and anaemia. The patient previously took amoxicillin, advil [ibuprofen], ibuprofen and experienced Allergies to medications. Patient received the vaccine on Thursday, 28Jan2021. That night she had extreme pain at the injection site. She could barely lift her arm without having a sharp pain. It felt like she could barely move it, it felt very heavy. Even when not moving my arm, there was a dull burning pain that was present. This pain continued into the next day, Friday, 29Jan2021. On Friday night, the pain was slowly subsiding. On Saturday, 30Jan2021, there was still a dull pain but she was able to move her arm and do daily activities again and she felt a lot better. On Sunday, 31Jan2021 her arm was completely normal again and there was no more pain. The patient received no treatment. Outcome of the events was recovered on 31Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Anemia; Asthma,,,"['Vaccination site movement impairment', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1045594,PA,48.0,F,"Headache; Sore arm; This is a spontaneous report received from a contactable consumer. A 48-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache and sore arm on 27Jan2021. The outcome of the events was reported as unknown. Information about Lot/ Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,,,,,,"['Headache', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 1045595,CO,27.0,F,"Dizzy; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK4176) intramuscularly in the left upper arm on 13Jan2021 at 14:45 (at the age of 27-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 13Jan2021, the patient was dizzy to the point of needing to lay down. The patient queried whether she should take the second dose. The patient did not receive treatment for this event, nor did the event require a visit to the emergency room or doctor's office. The clinical outcome of ""dizzy"" was resolved on 24Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,MIL,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Dizziness'],UNK,PFIZER\BIONTECH,OT 1045596,,,F,"tested positive for COVID virus; tested positive for COVID virus; This is a spontaneous report from a contactable consumer reporting on behalf of the patient via a Pfizer Sponsored Program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 25Jan2021 at a single dose for COVID immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received first dose of COVID vaccine on 25Jan2021, just after that, the patient tested positive for COVID virus on unspecified date in 2021. The patient's caregiver also tested positive, the caregiver has been quarantined and has been symptom free. The patient was in hospital for observation while having COVID. The reporter is wondering if the patient or caregiver (not sure if the caregiver received the first dose of COVID vaccine; pending clarification) is able to get the second dose of vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/25/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1045597,MI,25.0,F,"I started having intense chills; developed a fever of 102.5; I had a big headache as well; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received second dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: EL3248), via an unspecified route of administration right arm on 04Feb2021 06:45 at single dose for covid-19 immunization. Age at vaccination was 25 Years. Patient was not pregnant at the time of vaccination. Allergies to medications, food, or other products included Penicillin allergy. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications the patient received within 2 weeks of vaccination included Ovasitol. Historical vaccine included first dose of bnt162b2(COVID19, Pfizer, Lot number: EL3248) via an unspecified route of administration on right arm on 13Jan2021 06:45 at single dose for covid-19 immunization. On 04Feb2021 at 18:00, the night after she received the vaccine (12 hours afterward) she started having intense chills and developed a fever of 102.5. She had a big headache as well. Tylenol was received as treatment for the events. Outcome was recovering. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Body temperature', 'Chills', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH, 1045598,DE,57.0,F,"She tested positive for Covid 19 two weeks later; She tested positive for Covid 19 two weeks later; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient said that she was tested COVID-19 positive two weeks after (30Jan2021) the first dose on 16Jan2021. The patient said that she was fully recovered today and advised by their health department that she was fit to work. The patient was scheduled to have her second dose tomorrow 06Feb2021, concerning if there was a problem or if it was okay to take the second dose tomorrow. The outcome of the events was recovered. Information on Lot/Batch has been requested.; Sender's Comments: The reported tested positive for SARS-Cov-2 two weeks after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/16/2021,01/30/2021,14.0,UNK,,,,,,"['Drug ineffective', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1045599,OH,75.0,M,"It just about wiped out cognitive function; shallow breathing; panting; Not being able to get around; he shrunk from 6 foot getting older; exhausted; Hungover feeling/he felt like in his eye sockets and in his neck and everywhere that there was something in him, some unfamiliar sensation; The caller stated a few days ago he had an intense dizziness after he got the first dose of the vaccine.; little anxiety; change in heart rhythm/change in his pulse rate/His normal is usually 60 but in this case it was 56 to 60; slight headache; This is a spontaneous report from a contactable consumer and a consumer via Pfizer-sponsored program Pfizer First Connect. A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EZ5138), via an unspecified route of administration in the left arm on 29Jan2021 12:01 (age at time of vaccination: 75 years) at first single dose for COVID-19 immunization; Vaccination Facility: community clinic. Medical history included bone marrow donor from an unknown date and unknown if ongoing (about 20 years ago). There were no concomitant medications. The patient experienced the following events and outcomes: the caller stated a few days ago he had an intense dizziness after he got the first dose of the vaccine. on 01Feb2021 at 11:30 with outcome of recovering, it just about wiped out cognitive function on an unspecified date with outcome of unknown, slight headache on 29Jan2021 with outcome of unknown, little anxiety on 01Feb2021 with outcome of recovered on 02Feb2021, shallow breathing on an unspecified date with outcome of unknown, change in heart rhythm/change in his pulse rate/his normal is usually 60 but in this case it was 56 to 60 on 01Feb2021 with outcome of recovered on 02Feb2021, exhausted on 02Feb2021 with outcome of recovering, panting on an unspecified date with outcome of unknown, hungover feeling/he felt like in his eye sockets and in his neck and everywhere that there was something in him, some unfamiliar sensation on 02Feb2021 with outcome of recovering, not being able to get around on an unspecified date with outcome of unknown, he shrunk from 6 foot getting older on an unspecified date with outcome of unknown; all of which were medically significant. The events did not require a visit to a physician office or emergency room (ER). The patient did not receive any prior vaccinations within four weeks of the bnt162b2; and there were no additional vaccines administered on the same date of the Pfizer Suspect. The patient underwent lab tests and procedures which included blood pressure: good on an unspecified date, height: shrunk from 6 foot getting older on an unspecified date, heart rate: good on an unspecified date, pulse rate: 56 to 60 on an unspecified date. The caller stated a few days ago he had an intense dizziness after he got the first dose of the vaccine. This was 72 hours after the shot. He had the shot around 12:01 last Friday (29Jan2021). Monday (01Feb2021), about the same time, he had a very very intense dizziness that came on suddenly (came on in about 30 seconds) and it was full blown and it lasted for pretty much 24 hours. It slightly lessened after 20 hours but it was a day before he could stand up. It was not gradual, he knew right then he was in trouble, he couldn't sit up or roll over. He stated he was in great health but if he was taking medication or had a heart condition he doesn't think he would be available for this conversation. It stressed him out and he didn't know he could go that far and come back. He stated it was comparable to cardiac arrest and was a life threatening experience. If other people may have this reaction (if intoxicated or on drugs) they may not survive it. It was very very severe and scary. He stated his reaction seems extreme to everybody he knows. It just about wiped out cognitive function. He stated around here it doesn't seem that people are having severe reactions. He knows a couple people getting the shot, one who drinks, one who had diabetes and he let them know about this. Additional Context: The patient stated he wanted to report his experience and ask a question. The patient stated he received the first dose of the Pfizer COVID 19 vaccine on 29Jan2021 at 12:01 in the left arm. The patient did not use drugs or alcohol and did not have any medication and had good health. The patient's heart rate and blood pressure were good. The patient had a slight headache. Then 72 hours later on Monday at about 11:30 he started to get dizzy, suddenly, and it was very intense. The patient took about 12 steps and recognized it and got to the bed. By the time he got there he knew he was in trouble, he had little anxiety and noticed a change in heart rhythm. The dizziness was very intense and intensified when he went to bed and continued. Tuesday morning it lightened a bit and then around 11:30 on Tuesday it withdrew; exactly 72 hours from the vaccination. The patient felt okay now, except he was kind of exhausted and had a hungover feeling, not totally clear but he was walking around. The patient felt if a person had been intoxicated or on medication or had a heart condition, he did not think they would survive this. The patient was physically challenged to get through it with shallow breathing, really panting, and not being able to get around. The patient had to focus on his breathing, panting to get through it. It was serious for him. Initially he noticed the change in his pulse rate and kept checking his pulse. His normal is usually 60 but in this case, it was 56 to 60. The anxiety was mild, he was concentrating to keep calm. The patient stated: ""This is a world crisis, a year old and it is not ideal conditions but this might be a critical issue in terms of the negative effects being more severe than anticipated for certain groups of people and he wanted to discuss this concern with someone at Pfizer."" The patient added he wanted to make sure that Pfizer knew that the intensity of the experience was a 100, it was very extreme. The patient added he felt like in his eye sockets and in his neck and everywhere that there was something in him, some unfamiliar sensation that has now gone away. When he bent over yesterday, he was mindful that that the dizziness had gone away. The patient added he still felt tired. The patient mentioned he did not eat for a while with that dizziness. The patient was scheduled for the next dose on 19Feb2021 but was a little unsure about getting it. Follow-up (05Feb2021): New information reported from a contactable consumer includes: suspect vaccine (lot number; anatomical location, vaccination facility, Time), concomitant medications, reaction data (added events: Headache, Anxiety, Shallow breathing, Pulse abnormal, Exhaustion, Abnormal breathing, Feeling abnormal, Activities of daily living impaired, Body height decreased), outcomes updated and clinical course.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,OTH,,,Medical History/Concurrent Conditions: Bone marrow donor (About 20 years ago),,,"['Anxiety', 'Blood pressure measurement', 'Body height', 'Body height decreased', 'Cognitive disorder', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Headache', 'Heart rate', 'Hypopnoea', 'Loss of personal independence in daily activities', 'Pulse abnormal', 'Respiration abnormal']",1,PFIZER\BIONTECH, 1045600,FL,70.0,M,"night vision improved the night after he took the vaccine and seemed to be a stable improvement; This is a spontaneous report from a contactable consumer (patient himself). A 70-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9526, expiration date was unknown), via an unspecified route of administration on the left arm on 02Feb2021 at 09:30 at a single dose for COVID-19 immunization. The vaccine facility type was reported as the public health clinic/veterans administration facility. Relevant medical history included that the patient had beginnings of cataracts and his night vision was beginning to diminish from an unknown date. The patient had no known allergies. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. He was not tested for COVID post vaccination. The patient reported that it was not an adverse event, but his night vision improved the night after he took the vaccine on 03Feb2021 at 02:00, and seemed to be a stable improvement. The patient did not receive any treatment for the event. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/03/2021,1.0,PUB,,,Medical History/Concurrent Conditions: Cataracts; Decreased night vision,,,['Therapeutic response unexpected'],1,PFIZER\BIONTECH, 1045601,CA,77.0,F,"severe overall headache; nasal congestion; This is a spontaneous report from a contactable consumer (self-reported). A 77-year-old female patient (who was not pregnant at the time of vaccine) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9261), via an unspecified route of administration, at Left Arm on 03Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM 11), hypertension and hypothyroidism. Concomitant medication included metformin, levothyroxine sodium (SYNTHROID), hydrochlorothiazide, triamterene (DIU) and blood pressure medication (unspecified). The patient previously took ibuprofen and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination, included; blood pressure Med, metformin, synthroid, DIU. The patient was the not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 04Feb2021, the patient woke up at 3 AM with severe overall headache and nasal congestion. At 6: 30 am took Tylenol tabs 2. Had head and nasal congestion as well and no treatment was taken for nasal congestion. Symptoms did not clear up for nearly 10 hours. Outcome of the events was recovered on an unknown date in Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/04/2021,1.0,UNK,METFORMIN; SYNTHROID; DIU,,Medical History/Concurrent Conditions: Hypertension; Hypothyroidism; Type 2 diabetes mellitus (DM 11),,,"['Headache', 'Nasal congestion']",1,PFIZER\BIONTECH, 1045602,,,M,"Felt like an old man; Gout flare/gout attack; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got Pfizer vaccine and a huge gout flare/ gout attack the next day. Felt like an old man, but better now. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Feeling abnormal', 'Gout']",1,PFIZER\BIONTECH, 1045603,WA,68.0,F,"Bell's Palsy; Left sided droop of her mouth; Slight change in sensation all over her mouth; Unable to tightly close left eye, or able to raise left eyebrow; Slight numbness left side of face; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EM9810) in the left arm, at single dose, on 04Feb2021 at 14:15, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included high cholesterol and lichen planopilaris of the scalp, both from an unspecified date. No known allergies were reported. The patient had not experienced Covid-19 prior vaccination. Concomitant medications included ergocalciferol (VIT D); ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS); doxycycline; rosuvastatin and minoxidil. On 04Feb2021, at 17:00, the patient experienced a slight change in sensation all over her mouth with left sided droop of her mouth, unable to tightly close left eye, or able to raise left eyebrow. Also slight numbness left side of face. Emergency room/department or urgent care required. The patient went to Urgency Care diagnosed with Bel's Palsy. Treatment was received: prednisone and valacyclovir. The patient did not recover from the events a time of this report. Post the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,UNK,VIT D; AREDS; DOXYCYCLINE; ROSUVASTATIN; MINOXIDIL,,Medical History/Concurrent Conditions: High cholesterol; Lichen planopilaris,,,"['Facial paralysis', 'Hypoaesthesia', 'Movement disorder', 'Sensory disturbance']",1,PFIZER\BIONTECH, 1045604,MO,,F,"Diverticulitis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: diverticulitis (medically significant). The clinical course was reported as follows: The patient reported that she received the first dose of the vaccine on 25Jan2021. The patient was scheduled to take the second shot on 15Feb2021. The patient contracted diverticulitis and mentioned that it was ""nothing serious"" and was prescribed with ""common"" antibiotics such as metronidazole and ""cipro"" (ciprofloxacin). Therapeutic measures were taken as a result of diverticulitis. The clinical outcome of the event, diverticulitis, was unknown. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,,,UNK,,,,,,['Diverticulitis'],1,PFIZER\BIONTECH, 1045605,,36.0,F,"woke up feeling unwell a few hours ago; wife felt sluggish during the walk; her heart was racing; hands were shaking; she felt as if she was going to faint; This is a spontaneous report from a contactable consumer (patient's husband). A 36-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 05Feb2021 12:30 for Covid-19 immunisation, being a caregiver. The patient medical history and concomitant medications were not reported. The patient previously received flu vaccine for immunization and had side effects. On 06Feb2021 she woke up feeling unwell a few hours before reporting. Reporter and patient went for a 4 mile walk and she felt sluggish during the walk and her heart was racing, hands were shaking and she felt as if she was going to faint. When they arrived back home the reporter checked her heart rate and it was not that high and her symptoms were subsiding. The reporter would like to know if his wife should go to the ER. A few years before the patient had side effects from the flu vaccine so he was expecting her to have a reaction to the Pfizer COVID vaccine. The patient underwent lab tests and procedures which included heart rate: it was not that high on 06Feb2021. The outcome of events was recovering. The reporter assessed the events as not serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,UNK,,,,,,"['Heart rate', 'Malaise', 'Palpitations', 'Presyncope', 'Sluggishness', 'Tremor']",1,PFIZER\BIONTECH, 1045606,FL,,F,"felt like she had COVID all over again which last 48 hours; felt like she had COVID all over again which last 48 hours; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received first dose of COVID-19 vaccine on 30Jan2021 and stated that after her first COVID-19 vaccine she felt like she had COVID all over again which last 48 hours. She is asking if she has to get the second COVID-19 vaccine after having the virus. The patient recovered from the event on unspecified date. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,,,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1045607,,,F,"fever; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient developed a fever after getting her second COVID vaccine yesterday. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,,,UNK,,,,,,['Pyrexia'],2,PFIZER\BIONTECH, 1045608,KY,90.0,F,"Sore arm; Tiredness; This is a spontaneous report from a contactable consumer (patient's son). A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9261) via an unspecified route of administration on 24Jan2021 13:30 at a single dose for COVID-19 immunization. The patient had no medical history and family medical history. There were no concomitant medications. On 24Jan2021, the patient experienced sore arm and tiredness. Right after the vaccine she noticed her arm was sore. Later she also felt a tiredness. She was scheduled to receive the second dose 14Feb2021, but she was unsure if she will get it. The events did not require a visit to physician or ER. There were no additional vaccines administered on same date of Pfizer suspect. Prior to vaccination, the patient was not diagnosed with COVID-19. The facility where the vaccine was administered was in a hospital. No relevant tests done. The event sore arm recovered on 28Jan2021, while the event tiredness on 26Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/24/2021,01/24/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH, 1045609,,,F,"Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for herself and her husband. This is the first of two reports. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient tested positive for COVID-19 and had minor symptoms on an unspecified date. Outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021111850 same reporter/drug, similar events, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1045610,,40.0,M,"severe headache 8hours after second shot; chills at 12hours; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot_number El3248), via an unspecified route of administration at single dose in the left arm on 04Feb2021 07:00 AM for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on 14Jan2021 08:00 AM in the left arm for covid-19 immunisation. On 04Feb2021, the patient experienced severe headache 8hours after second shot, chills at 12hours. No treatment required. The outcome of the events was recovered on an unspecified date in Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,UNK,,,,,,"['Chills', 'Headache']",2,PFIZER\BIONTECH, 1045611,FL,35.0,F,"large quarter sized hives all over; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via unspecified route of administration on left arm on 05Feb2021 at 08:30 AM at single dose for COVID-19 immunization. The relevant medical history included known allergies: lyrica, possibly cilantro, pollens; insulin resistance; vitamin D def (Vitamin D deficiency); GERD (Gastrooesophageal reflux disease). Concomitant medications included metformin, famotidine (PEPCID), clarithromycin (CLARTIN), topirmate, diphenhydramine hydrochloride (BENEDRYL). The patient previously received first dose of BNT162B2 (lot number: EH9899) at the age of 35 years old, via unspecified route of administration on left arm on 11Jan2021 at 03:30 PM for COVID-19 immunization (first vaccine administered and was fine then had hives and swollen eye on the day the second was to be administered. Delayed shot- received solumedrol shot and prednisone oral with benedryl/pepcid/atarax). The patient took second shot 1 week later on Friday with prednisone on board - woke up on Sunday AM with large quarter sized hives all over. The event resulted in emergency room/department or urgent care. The event was reported serious due to hospitalization. Treatment received included urgent care- Solumedrol shot- RXs. No other vaccine in four weeks. The outcome of the event was recovering.; Sender's Comments: Based on available information and plausible temporal association, a possible contributory role of the subject drug BNT162B2 cannot be excluded for the reported event large quarter sized hives all over. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/05/2021,02/01/2021,,PVT,METFORMIN; PEPCID [FAMOTIDINE]; CLARITIN [CLARITHROMYCIN]; TOPIRAMATE; BENADRYL,,Medical History/Concurrent Conditions: Allergy to plants; GERD; Insulin resistance; Pollen allergy; Vitamin D deficiency,,,['Urticaria'],2,PFIZER\BIONTECH, 1045613,FL,77.0,F,"chills; slight headache; joints aching; muscles aching; fatigue; weakness; This is a spontaneous report from a contactable healthcare professional. A 77-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 06Feb2021 14:00 at a single dose for covid-19 immunization. The patient medical history was reported as none. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included bupropion, levothyroxine, sumatriptan succinate (IMITREX) and vitamin nos (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3246) at the age of 77-year-old via an unspecified route of administration right arm on 16Jan2021 14:00 at a single dose for covid-19 immunization. On 07Feb2021 11:00 PM (reported as 33 hours post [23:00] second vaccination), the patient had chills, slight headache, joints aching, muscles aching, fatigue and weakness. The patient has not been tested for COVID-19 since the vaccination. The events were non-serious, and the patient did not received treatment for the adverse events. The outcome of the events was recovered on Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/07/2021,1.0,UNK,BUPROPION; LEVOTHYROXINE; IMITREX; MULTIVITAMINS [VITAMINS NOS],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Arthralgia', 'Asthenia', 'Chills', 'Fatigue', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH, 1045614,CO,72.0,F,"shingles; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EN5318; expiration date: unknown), via an unspecified route of administration left arm on 30Jan2021 08:00 at a single dose for covid-19 immunisation . The patient 's medical history was none. Concomitant medication included NP [pending clarification]. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she did not have side effects from the shot. The patient added that 2 days after the shot (01Feb2021 08:00 AM), she got shingles. The patient reported that the event as non-serious. She received treatment for the event (medicine) and the adverse event result in doctor or other healthcare professional office/clinic visit. The patient has not been for COVID-19 since the vaccination. The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/01/2021,2.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Herpes zoster'],1,PFIZER\BIONTECH, 1045615,OR,25.0,F,"Left hand, specifically thumb, has numbness and tingling; Left hand, specifically thumb, has numbness and tingling; Unable to perform daily activities with this hand after vaccination.; muscle weakness in right thigh.; This is a spontaneous report from a contactable Other HCP (patient). A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular in right arm on 06Feb2021 07:45 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included isotretinoin (ACCUTANE). The patient previously received first dose of BNT162B2 on unknown date 11:15 on right arm. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient had no Known allergies. On 06Feb2021 14:00, the patient had Left hand, specifically thumb, has numbness and tingling. Unable to perform daily activities with this hand after vaccination. Also muscle weakness in right thigh. It was unknown if treatment was received for the events. The events resulted in Disability or permanent damage. The outcome of all events was not resolved. Information about lot/batch number has been requested.; Sender's Comments: A contribution from BNT162B2 to reported events cannot be fully excluded based on the temporal relationship and lack of alternate explanation at this time. Case will be reassessed if additional information is received The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Yes,N,02/06/2021,02/06/2021,0.0,WRK,ACCUTANE,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Hypoaesthesia', 'Loss of personal independence in daily activities', 'Muscular weakness', 'Paraesthesia']",2,PFIZER\BIONTECH,OT 1045616,,,F,"a recurrence of cellulitis in her right arm; a recurrence of cellulitis in her right arm; headache; sore arm; Lymphoedema; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program, Pfizer First Connect. A 78-year-old female patient received the first (1st) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Jan2021 at a single dose as COVID vaccine. Medical history included cancer survivor and cellulitis in her right arm from being a cancer patient. Concomitant medication included quinine sulfate (LEXIQUIN). It was reported that after the 1st dose of the vaccine, the patient experienced a very bad headache and a sore arm on 2021 and didn't want to miss her 2nd dose. She wanted to know if it's still alright to get her 2nd dose and had some other questions. Her 1st dose of the Pfizer COVID vaccine was 2 weeks ago, afterwards on 2021, a recurrence of cellulitis in her right arm from being a cancer patient; she was put on Levaquin and her doctor told her she may absolutely not get her 2nd dose until at least 15 days after her Levaquin treatment. She's supposed to go for second shot this Saturday (also reported as Friday) but ended up coming down with lymphoedema on 2021. She also came down with cellulitis in her arm after receiving the first injection, which happens a lot to her. She's still on Levaquin and would be done in 3 days. She would like to know how many days she needed to wait to get the vaccine after stopping that. She would like to know how long she could wait in between doses and whether the effects of the 2nd dose of the COVID vaccine would be worse than the 1st. She would also like to know if she has to wait too long, what would happen. Would she need to start all over again? She also wanted to know about getting a new appointment. She spoke to the CDC yesterday and they told her 45 days, and she wanted to know if that was alright or not. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,,,UNK,LEXIQUIN,,Medical History/Concurrent Conditions: Cancer (cancer survivor); Cellulitis of arm (from being a cancer patient),,,"['Cellulitis', 'Disease recurrence', 'Headache', 'Lymphoedema', 'Pain in extremity']",1,PFIZER\BIONTECH, 1045617,,,M,"passed-out/he fell; light-headed; passed-out/he fell; This is a spontaneous report from a contactable other healthcare professional reported that an 82-year-old male patient received the first dose of bnt162b2 (BNT162B2 also reported PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for Covid-19 immunisation. Medical history included high blood pressure and stents. He was on a blood thinner medication. On unspecified date, he felt light-headed. He passed-out a week and a day after the first injection, when he bent over to get something out of the dishwasher. He was found on the ground with broken dishes and he didn't recall how he fell. He was sent to his cardiologist who did an EKG, a blood pressure reading then took his heartrate, and everything was fine. The outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Blood pressure high; Stent placement,,,"['Blood pressure measurement', 'Dizziness', 'Electrocardiogram', 'Fall', 'Heart rate', 'Loss of consciousness']",1,PFIZER\BIONTECH, 1045618,NM,,F,"she was so miserable; terrible headache; lips and tongue were burning; lips and tongue were burning; anaphylactic event; little nauseas/severe nausea/she was so nauseas/nausea was overwhelming; This is a spontaneous report from a contactable consumer (patient). A elderly (reported as almost 80 years old) female patient received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on 02Feb2021 13:30 at single dose for covid-19 immunization. Medical history included allergy to latex and shellfish (iodine), cancer, anaphylactic reaction she had 15-20 years ago where it was much worse and she could not swallow or breathe. The patient's concomitant medications were not reported. Patient received her 1st dose of the Pfizer covid vaccine. She is reported to have experienced severe nausea and terrible headache, lips and tongue were burning which she says reminds her of an anaphylactic reaction she had 15-20 years ago where it was much worse and she could not swallow or breathe. Patient would like to know whether her side effects are normal and her side effects post- vaccine whether they have been reported before. Patient would like to know if the 2nd shot of the covid vaccine is going to be worse and if the side effects after the 1st dose are going to be worse. She received the first COVID-19 vaccine on 02Feb2021. She felt fine until late that evening. She got a little nauseas. It just so happens the next day she was scheduled for her 3 month check-up with her internist. She told the doctor she was a little nauseas that last night, but was fine that day. She clarified further she received the COVID-19 vaccine on 1:30pm on 02Feb2021. Around 3:00pm on 03Feb2021, she was so nauseas, she was so miserable. She called the pharmacist and asked what could she possibly take. The pharmacist told her to drinks lots of water, drink Gatorade, and have her doctor order something to treat the nausea. Caller states she couldn't get a hold of her doctor. However, she did what the pharmacist told her to do by drinking water and Gatorade. The nausea was overwhelming. She got this terrible headache. Later in the day, her lips and tongue were burning. She thought to herself ""oh my gosh, I'm having an anaphylactic event"". She does keep an EpiPen on her. She took 2 Benadryl. She didn't know if she could take Advil and Benadryl at the same time, so she didn't do that. She is in sort of panic to get the second shot. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/02/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Anaphylactic reaction (she had 15-20 years ago where it was much worse and she could not swallow or breathe); Cancer; Iodine allergy; Latex allergy; Shellfish allergy,,,"['Anaphylactic reaction', 'Feeling abnormal', 'Headache', 'Nausea', 'Oral discomfort', 'Tongue discomfort']",1,PFIZER\BIONTECH, 1045619,TN,62.0,F,"The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; pain in neck; pain in left shoulder; The shortness of breath lasted over; My lips were tingly; I could feel the end of my nose. My throat was closing/throat closing a little bit; I had pain in my arm; my muscles ached.; The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; anaphylaxis; allergic reaction to the first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN5318), via an unspecified route of administration on 22Jan2021 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included drug allergies from an unknown date. There were no concomitant medications. The patient experienced anaphylaxis on an unspecified date in 2021. The patient had a little bit of an allergic reaction to the first dose of the Pfizer COVID 19 vaccine in 2021, it was not severe enough to use an Epipen. The shortness of breath from 22Jan2021 18:00 lasted over a week. Her lips were tingly from 22Jan2021 14:30, she could feel the end of her nose. Her throat was closing from 22Jan2021 14:30. She had pain in her arm from 22Jan2021 11:00, and her muscles ached from an unspecified date in 2021, the left side of her face, ear, throat and teeth hurt (facial pain from an unspecified date in 2021, ear pain from 22Jan2021 23:00, throat pain from an unspecified date in 2021, tooth pain from 22Jan2021 23:00), pain in left shoulder from 22Jan2021 20:30, pain in neck from 22Jan2021 23:00. She did have to take Benadryl for treatment of shortness of breath. She felt better after 1.5 weeks. The outcome of events anaphylaxis, allergic reaction, muscles ached, Facial pain, Throat pain was unknown, outcome of event pain in arm was resolving, outcome of event tooth pain was resolved on 23Jan2021, outcome of shortness of breath was resolved on 01Feb2021, outcome of other events was resolved on 24Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Drug allergy,,,"['Allergy to vaccine', 'Anaphylactic reaction', 'Arthralgia', 'Dyspnoea', 'Ear pain', 'Facial pain', 'Myalgia', 'Neck pain', 'Oropharyngeal pain', 'Pain in extremity', 'Paraesthesia oral', 'Throat tightness', 'Toothache']",1,PFIZER\BIONTECH, 1045620,,,F,"She experienced a sudden deafness in her right ear in between receiving both her shots.; This is a spontaneous report from a consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date not reported), via an unspecified route of administration on 16Jan2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a sudden deafness in her right ear in between receiving both her shots. Her second dose was on 06Feb2021. The outcome of event was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,,,UNK,,,,,,['Sudden hearing loss'],1,PFIZER\BIONTECH, 1045621,AZ,83.0,M,"vision loss; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: 183599) solution for injection, via an unspecified route of administration in left arm on 20Jan2021 at a single dose for Covid-19 immunization. Medical history included pacemaker, vitiligo, psoriasis, blood pressure, and autoimmune disorder. Concomitant medications included blood thinners and blood pressure medications. The patient experienced vision loss on an unspecified date. It was reported that patient went for an office/clinic visit to a doctor or other healthcare professional. Also went emergency room/department or urgent care. Patient did not receive any treatment. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not tested positive for Covid-19 since vaccination. Covid-19 virus test: negative. The event was reported as non-serious however it caused disability. Outcome of the event was not recovered. No follow-up activities are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/20/2021,,,UNK,,,Medical History/Concurrent Conditions: Autoimmune disorder; Blood pressure abnormal; Pacemaker insertion (cardiac); Psoriasis; Vitiligo,,,"['Blindness', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1045622,CO,22.0,F,"phrenic nerve damage resulting in unilateral diaphragm paralysis; phrenic nerve damage resulting in unilateral diaphragm paralysis; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at the left arm on 03Feb2021 11:45 (lot number EN9581 and expiry date unknown) at single dose for Covid-19 immunization in the physician office (doctor's office/urgent care). Medical history included anxiety, scoliosis, milk thistle allergies, laundry detergent fragrance allergies. The patient has no covid prior vaccination. Concomitant medication included clonazepam (KLONOPIN), ascorbic acid, colecalciferol, copper gluconate, cyanocobalamin, durapatite, folic acid, glucosamine hydrochloride, magnesium oxide, manganese sulfate, phytomenadione, sodium borate decahydrate, zinc amino acid chelate (BONE UP) and ""multi-vita""; all from unspecified date for unspecified indication. The patient previously took diflucan and experienced allergies. The patient had no other vaccine in four weeks. On 05Feb2021 (two days after receiving vaccination), the patient experienced phrenic nerve damage resulting in unilateral diaphragm paralysis. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment due to the events. The patient was not covid tested post vaccination. The outcome of the events was recovering. Follow-up activities are possible, information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/05/2021,2.0,PVT,KLONOPIN; BONE UP,,Medical History/Concurrent Conditions: Allergy to plants; Anxiety; Reaction to fragrance; Scoliosis,,,"['Diaphragmatic paralysis', 'Phrenic nerve injury']",1,PFIZER\BIONTECH, 1045624,,,F,"Patient passed hit her head; Stroke; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sales representative. A 68-year-old female patient received single dose of BNT162B2(Solution for injection, lot number and exp date not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. The patient did not have COVID prior vaccination. On an unspecified date, the patient passed hit her head and had emergency surgery; and stroke. The adverse events resulted in: Hospitalization (date/s unspecified). The patient was not covid tested post vaccination. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,"['Cerebrovascular accident', 'Head injury']",UNK,PFIZER\BIONTECH, 1045625,VA,22.0,F,"Syncopal episodes X 4; Fever; chills; pain/aches; Condition Aggravated; This is a spontaneous report from a non-contactable consumer. A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284) intramuscularly in left arm on 22Jan2021 at single dose for COVID-19 immunization. Medical history included traumatic brain injury from 2019 and ongoing, syncope from 2019 and ongoing (both reported as current Illness: traumatic brain injury? 2019 syncope? 2019). Concomitant medication included midodrine. The patient experienced fever, chills, pain/aches, on 22Jan2021 pm, condition aggravated on 22Jan2021, syncopal episodes X 4 on 23Jan2021 - transferred to ed - admitted. Events categories per reporter was permanent disability, hospitalized (3 days in hospital), emergency room visited. No office visited. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Yes,3.0,Yes,N,01/22/2021,01/22/2021,0.0,UNK,MIDODRINE,Syncope (Current Illness: Traumatic Brain Injury ? 2019 Syncope ? 2019); Traumatic brain injury (Current Illness: Traumatic Brain Injury ? 2019 Syncope ? 2019),,,,"['Chills', 'Condition aggravated', 'Pain', 'Pyrexia', 'Syncope']",2,PFIZER\BIONTECH,OT 1045626,AL,21.0,F,"My left and right arms have began to tingle; left and right arms go slightly numb 3-4 times per day for about an hour in length.; first dose on 29Jan2021 at 01:15 PM and second dose on 6Feb2021 at 03:00 PM; first dose on 29Jan2021 at 01:15 PM and second dose on 6Feb2021 at 03:00 PM; This is a spontaneous report from a contactable other healthcare professional (patient). A 21-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration in the left arm, on 06Feb2021 at 15:00, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included unspecified birth control and venlafaxine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247) on 29Jan2021 at 13:15, in the left arm for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. The patient reported that on an unspecified date, her left and right arms began to tingle and went slightly numb 3-4 times per day for about an hour in length. The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events ""My left and right arms have began to tingle"" and ""left and right arms go slightly numb 3-4 times per day for about an hour in length"" was not recovered. The patient has not been tested for COVID-19 since vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/06/2021,0.0,PVT,VENLAFAXINE,,,,,"['Hypoaesthesia', 'Inappropriate schedule of product administration', 'Off label use', 'Paraesthesia']",2,PFIZER\BIONTECH, 1045627,,,F,"rash; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination. The patient experienced rash on Jan2021. It was unknown if treatment was received for the adverse event. Clinical outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/01/2021,,UNK,,,,,,['Rash'],UNK,PFIZER\BIONTECH, 1045628,OH,55.0,F,"Intense itching throughout my entire body; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9269; Expiration date was not reported) on 05Feb2021 (16:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included asthma, high cholesterol and high blood pressure. The patient's concomitant medications were not reported. The patient previously took prochlorperazine maleate (COMPAZINE), and had drug allergy. The patient was not pregnant at the time of vaccination. On 05Feb2021 (18:00), two hours after the vaccination, the patient had intense itching throughout the entire body. There were no hives or rash, just the unbearable itching. The patient had received diphenhydramine (BENADRYL) as treatment for the event. The outcome of the event, intense itching throughout the entire body, was recovered in Feb2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Asthma; Blood pressure high; High cholesterol,,,['Pruritus'],1,PFIZER\BIONTECH, 1045629,MA,53.0,F,"Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; nausea night of 2nd inj and next day; Severe fatigue; joint pain; I felt very ill; akin to the flu; This is a spontaneous report from a contactable nurse(patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 02Feb2021 11:45 AM at a single dose for COVID-19 immunization. Medical history included Crohns disease which is in remission (No immunosuppressants in 5 years) and shellfish sensitivity. The patient received the first dose of BNT162B2 on 15Jan2021 for covid-19 immunization and experienced syncope. The patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Concomitant medication included duloxetine hydrochloride (CYMBALTA), trazodone, buspirone hydrochloride (BUSPAR), lisdexamfetamine mesilate (VYVANSE) methylfolate and Ma. The patient experienced syncope after injection in Feb2021. A few episodes in 18 hrs, the patient experienced headache, body aches, intermittent fevers with flushing/chills, nausea night of 2nd injection and next day in Feb2021. The patient experienced severe fatigue, joint pain, felt very ill, akin to the flu in Feb2021.No treatment received for the adverse events. The patient underwent lab test included body temperature: intermittent fevers in Feb2021.The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: A contribution from BNT162B2 to the event syncope is possible based on available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/01/2021,,PVT,CYMBALTA; TRAZODONE; BUSPAR; VYVANSE; METHYLFOLATE,,Medical History/Concurrent Conditions: Crohn's disease (Crohns Disease which is in remission. No immunosuppressants in 5 years); Shellfish allergy (Allergies: Shellfish sensitivity),,,"['Arthralgia', 'Body temperature', 'Chills', 'Fatigue', 'Flushing', 'Headache', 'Influenza like illness', 'Malaise', 'Nausea', 'Pain', 'Pyrexia', 'Syncope']",2,PFIZER\BIONTECH, 1045630,NE,55.0,F,"she had a reaction to PEG in the lipids of the vaccine; had Anaphylactic shock/anaphylactic reaction; a cardiovascular event /she had ventricular arrhythmias/Premature ventricular contractions; has High blood pressure sustained until today /Blood pressure still elevated to; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A contactable Nurse (patient) reported a 55-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 03Feb2021 into right arm at a single dose for covid-19 immunisation. She reported having numerous allergies including fish, seafood, cats, sheep/lanolin, plants, and trees. The patient's concomitant medications were not reported. The patient usually doesn't have high blood pressure, but she had high blood pressure sustained until today, chest pains, hives immediately and itching on right arm where the shot was, felt welted and had different ventricular beats, short of breath. Doctors gave her Solumedrol- was given Morphine for blood pressure. The patient was admitted overnight and Blood pressure still elevated to and PVC (Premature ventricular contractions). The patient wanted to know what she can do to help this. The patient received the first Pfizer Covid vaccine dose on 03Feb2021. Within 1 minute experienced an anaphylactic reaction/shock and a cardiovascular event. She stated she had ventricular arrhythmias and is now on a beta-blocker for treatment. She thought that she had a reaction to PEG in the lipids of the vaccine. She wanted to know where the PEG is derived from. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the information available and temporal relationship, a causal association between BNT162B2 and the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/03/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Allergy to animal; Allergy to lanolin; Allergy to plants; Fish allergy; Seafood allergy,,,"['Anaphylactic shock', 'Blood pressure measurement', 'Hypertension', 'Reaction to excipient', 'Ventricular extrasystoles']",1,PFIZER\BIONTECH, 1045631,,,U,"anaphylactic reaction; This is a spontaneous report from a Pfizer-sponsored program Pfizer RXPathways received by a contactable consumer(patient). A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction to the first dose of the vaccine on an unspecified date and went to the hospital with outcome of unknown. Information on the Lot/Batch Number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Anaphylactic reaction'],1,PFIZER\BIONTECH, 1045632,,,F,"swollen tongue; swollen tongue and lips; worsened; rash; This is a spontaneous report from a contactable consumer (patient) via pharmacist. This adult female patient (age late 50) received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. 15 mins after the 1st dose Pfizer Covid vaccine, the patient had runny ones swollen tongue and lips. Benedryl was administered, symptoms improved then worsened. Transport was called to hospital epi administered. RX steroids at the time of reporting was day 9 post vacc administration, the patient was still on steroids and continued rash. The patient described blood dripping from arm post stick. The patient wonder if administration was not IM. Event took place after use of product. Outcome of the events was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,"['Condition aggravated', 'Lip swelling', 'Rash', 'Swollen tongue']",1,PFIZER\BIONTECH, 1045633,TX,,M,"Has been hospitalized with COVID for 10 days now; Has been hospitalized with COVID for 10 days now; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. The patient had no underlying condition. The patient's concomitant medications were not reported. The patient's wife reported that the patient has been hospitalized with COVID for 10 days now since an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/14/2021,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['COVID-19', 'Drug ineffective']",UNK,PFIZER\BIONTECH, 1045634,FL,,M,"Acute arm pain; chills; fever 40�C; loss of oxygen and conscience/diagnosed with pneumonia; loss of oxygen and conscience; This is a spontaneous report from a contactable consumer (patient). An 87-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: el9263) via an unspecified route of administration on 06Feb2021 14:15 at single dose in left arm for COVID-19 immunisation. Medical history included severe COPD (chronic obstructive pulmonary disease), atrial fibrillation, reflux gastritis, and was allergic to Penicillin. On 07Feb2021, the patient experienced acute arm pain, 2 days later chills, and 5 days later fever 40�C, loss of oxygen and conscience, 911 call diagnosed with pneumonia. Later they gave another diagnosis, the next day, no fever and no pain in the arm. The patient received antibiotics and steroids as treatment. Events resulted in visit to physician's office or another health professional, emergency room, hospitalization, potential mortal disease (immediate risk of death due to event). Events outcome was recovered on Feb2021. The patient hospitalized due to events for 4 days. The patient underwent lab tests and procedures which included body temperature 40�C on 07Feb2021, COVID test via nasal swab on 11Feb2021 with result of Negative.",Not Reported,,Yes,Yes,4.0,Not Reported,Y,02/06/2021,02/07/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Atrial fibrillation; COPD; Penicillin allergy; Reflux gastritis,,,"['Body temperature', 'Chills', 'Oxygen saturation decreased', 'Pain in extremity', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1045635,MO,74.0,M,"Death; Passed out; Stomach was bothering; Constipated; Difficulty breathing; Weakness/Event: Weakness was reported as worsened; a temperature of 99.4 degrees; Sweaty; Cold; Muscle ache; Body Aches; Diarrhea; Nausea; Vomiting; Fatigue/Tiredness; His raspy throat felt like he had mucus stuck in his throat; Cough; Raspy throat/worsened; This is a spontaneous report from a contactable consumer reporting her husband. A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EM9810, Expiry Date: Jun2021) at the age of 74- year-old via an unspecified route of administration on 04Feb2021 09:15 at single dose in Arm, Right for COVID-19 immunisation. Medical history included type 2 diabetes mellitus for about 20-25 years, ongoing kidney disease from 2005, ongoing chronic kidney disease, cardiac pacemaker insertion. The patient was diagnosed with kidney disease in 2005, but it was about 1 to 1-1/2 years ago that his kidney disease progressed to Stage 4 Kidney Disease. She said the Veterans Administration diagnosed her husband with his kidney disease, but her husband saw a private doctor, as well as, a VA doctor for his care. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot Number: EL3248; Expiration Date: Apr2021) at the age of 74- year-old Intramuscularly at approximately 08:45AM on 15Jan2021 in right arm for COVID-19 immunisation and had no reaction. There were no additional vaccines administered on same date of the Pfizer suspect. There were no Prior Vaccinations within 4 weeks. The patient had symptoms start earlier in the day of Tuesday, 09Feb2021, after his second COVID-19 Vaccine shot (04Feb2021). The reporter said she and her husband didn't think anything of his symptoms at first. The patient had a temperature of 99.4 degrees on 09Feb2021. She didn't check her husband's temperature again after that time because the nurse at her husband's doctor's office said her husband's temperature was not at an area of concern. The patient was sweaty, off and on, starting 09Feb2021. She clarified he would be sweaty and the cold, but nothing extreme. The patient developed muscle aches, body aches, diarrhea, nausea, and vomiting on 09Feb2021. She clarified her husband had fatigue, tiredness, and had trouble with a raspy throat. His raspy throat started Tuesday evening (09Feb2021). His raspy throat felt like he had mucus stuck in his throat, and he was unable to clear the mucus from his throat. The reporter called her husband's primary care doctor on the morning of 10Feb2021 because her husband was having trouble with a raspy throat, and difficulty breathing. She said on Tuesday night (09Feb2021) her husband had to sleep sitting up because he couldn't lay down with his breathing. He was able to eat breakfast (clarified as oatmeal and an orange), lunch (clarified as soup and a salad), and dinner (clarified as soup and half a sandwich. She said her husband ate all the meat and half of the bread on the sandwich) on 10Feb2021. Her husband's primary care doctor wasn't available to speak to on Wednesday morning (10Feb2021), but the doctor's nurse said it sounded like her husband was having a reaction to his second COVID-19 Vaccine shot. The reporter said her husband's doctor instructed her later in the day to take her husband to the Emergency Room or Urgent Care if he didn't feel any better. Her husband's throat raspiness got worse in the evening of 10Feb2021. His breathing also became worse after dinner in the evening of 10Feb2021. The patient leaned forward over a couple pillows while sitting on their couch as it was easier for him to breath by doing that. They decided at 11:00PM that her husband should go to the Emergency Room. She said her husband was getting very weak, so she and her husband debated if she should call # for an ambulance, or if she should drive him to the Emergency Room. She said her husband was able to dress himself, but with some difficulty, and she assisted walking him from their house to their car. She said she had turned to walk away from her husband while he was at the side of their car, and then she heard her husband make a noise. He had appeared to have passed out. She clarified in the past, her husband had passed out prior to his pacemaker. She said she dialed #, and the # operator told her how to tell if her husband was still breathing. She said she couldn't tell if her husband was still breathing. She said when the ambulance arrived at her house, the ambulance staff worked on her husband for a long time. The reporter thought her husband had died at the time he had collapsed at the side of their car. The patient took a sugar free cough syrup Tuesday night (09Feb2021), and then again a couple times on Wednesday (10Feb2021) as treatment. The patient had thrown up a couple times, but found that the sugar free cough syrup soothed his cough the night before (09Feb2021). She said her husband had taken 2 TUMS early on Wednesday morning at approximately 2:00AM (10Feb2021). He had said his stomach was bothering him on 10Feb2021. He said he thought he may be constipated, so he took 1 Senokot (Clarified as GeriCare Senna-Plus Natural Vegetable Laxative with Stool Softener) on 10Feb2021. She clarified her husband had diarrhea on 09Feb2021, but felt on 10Feb2021 he may have been constipated. There were no adverse events required a visit to Emergency Room since Patient's wife stated she was getting her husband to their car, so she could drive him to the Emergency Room, when her husband collapsed and died or to Physician Office as they spoke with the nurse at her husband's primary care doctor's office. Weakness was reported as worsened. The outcome of events Sweaty, Cold, Muscle ache, Body Aches, Fatigue/Tiredness, Raspy throat/worsened, Difficulty breathing, Weakness was not recovered; and of the remaining events was unknown. The patient died on 11Feb2021. The patient's official time of death was Thursday, 11Feb2021, at 12:08AM. Cause of death was unknown. An autopsy was not performed and it would take 3 weeks for a death certificate to be issued. The reporter stated she thought it was important to notify Pfizer of her husband's passing because his side effects fell within the expected time period after receiving his second COVID-19 Vaccine.; Reported Cause(s) of Death: Death",Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/09/2021,5.0,PVT,,Chronic kidney disease stage 4; Kidney disorder,Medical History/Concurrent Conditions: Pacemaker insertion (cardiac); Type 2 diabetes mellitus,,,"['Abdominal discomfort', 'Asthenia', 'Body temperature', 'Constipation', 'Cough', 'Death', 'Diarrhoea', 'Dysphonia', 'Dyspnoea', 'Fatigue', 'Hyperhidrosis', 'Loss of consciousness', 'Myalgia', 'Nasopharyngitis', 'Nausea', 'Pain', 'Pyrexia', 'Sensation of foreign body', 'Vomiting']",2,PFIZER\BIONTECH, 1045636,MS,33.0,M,"diagnosed with vertigo; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Very hard time focusing my eyes; Extreme burning and tingling sensation over his entire body; Extreme burning and tingling sensation over his entire body; extremely dizzy; confused; nauseous; uncontrollably shaking; Headache; This is a spontaneous report from a contactable consumer reporting for himself. A 33-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 01Feb2021 at 11:00 AM, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. Patient had no known allergies and did not receive other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination. On 01Feb2021 at 12:00 PM the patient developed a headache. Over the next few hours the headache moved to the back of his neck and base of his skull. On 03Feb2021 the patient experienced very hard time focusing his eyes and extreme burning and tingling sensation over his entire body, he was extremely dizzy, confused, nauseous and uncontrollably shaking. Patient went to his family doctor and was diagnosed with vertigo on 05Feb2021. Patient took meclizine with no relief. On 10Feb2021 the patient was visited by another doctor and went under two days of testing including acoustic stimulation tests, balance test, visual acuity tests, CT scan and MRI all with unknown result. The doctor said the vaccine shot caused an allergic reaction which elevated patient's spinal cord pressure and brain stem swelling. Therapeutic measures were taken as a result of spinal cord pressure and included treatment with Diamox. Outcome of the events was not resolved. The events were considered serious as life-threatening and as per disability. Patient was not tested positive for COVID-19 after vaccination. The information on the lot/batch number has been requested.",Not Reported,,Yes,Not Reported,,Yes,N,02/01/2021,02/01/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Acoustic stimulation tests', 'Balance test', 'Brain stem syndrome', 'Burning sensation', 'Computerised tomogram', 'Confusional state', 'Dizziness', 'Headache', 'Hypersensitivity', 'Magnetic resonance imaging', 'Nausea', 'Paraesthesia', 'Spinal cord disorder', 'Tremor', 'Vertigo', 'Vision blurred', 'Visual acuity tests']",1,PFIZER\BIONTECH, 1045637,MI,,F,"I passed out, I was unconscious on the floor, my eyes were open and looked very strange he said, I was making gurgling sound.; I was unconscious on the floor/Tried to wake me up but it didn't work; Lethargic; This is a spontaneous report from a contactable consumer (patient). A 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration at left arm on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that: "" I passed out the next morning for about 8 minutes my husband said, I was unconscious on the floor, my eyes were open and looked very strange he said, I was making gurgling sound. He threw water on me and he tried to wake me up but it didn't work. I came out of it I was very lethargic the whole day but the next day I was feeling a little bit better"". No therapeutic measures were taken as a result of events. The patient outcome of lethargic was recovering; the outcome of the other events was recovered. The information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Lethargy', 'Loss of consciousness', 'Syncope']",2,PFIZER\BIONTECH, 1045638,TX,48.0,F,"I am diabetic and my blood sugar dropped in the middle of the night; I am diabetic and my blood sugar dropped in the middle of the night; Sleeping a lot; Confusion; This is a spontaneous report from a contactable consumer, the patient. A 48-years-old female patient received bnt162b2 (BNT162B2, Lot Number Unknown) via an unspecified route of administration on an unspecified date (at 48 years of age) as a SINGLE DOSE for Covid-19 Vaccination , insulin (INSULIN) 'regular Insulin for sliding scale' Lot Number Unknown 'number under the bar code C:1011:1030310691833329. via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for diabetes mellitus , insulin detemir (LEVEMIR) Lot Number 310018652576, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for diabetes mellitus , insulin aspart (NOVOLOG) Lot Number 374934031098, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for diabetes mellitus , semaglutide (OZEMPIC) weekly, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose, weekly for diabetes mellitus. Medical history included hypertension. Concomitant medication included lisinopril (LISINOPRIL). The patient reported I am diabetic and my blood sugar dropped in the middle of the night, so my husband had to get up and give me something (Unspecified Medication) and then I am sleeping a lot and I do have some confusion on an unspecified date. The patient underwent lab tests that included blood glucose: dropped on an unspecified date. Treatment was given for diabetic and blood sugar dropping. Consumer also stated, No, it is not that severe The clinical outcome of the events diabetic, blood sugar dropped in the middle of the night, Sleeping a lot and Confusion was Unknown. The action taken in response to the event(s) for insulin was unknown, for insulin detemir was unknown, for insulin aspart was unknown, for semaglutide was unknown. The lot number for the vaccine, bnt162b2 was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,"LISINOPRIL; INSULIN; OZEMPIC; LEVEMIR, NOVOLOG",,Medical History/Concurrent Conditions: Hypertension,,,"['Blood glucose', 'Blood glucose decreased', 'Confusional state', 'Diabetes mellitus', 'Somnolence']",UNK,UNKNOWN MANUFACTURER, 1045639,MO,54.0,F,"Left eyelid and area between my eyes was completely numb; Numbness in lip area; Numbness in chin/Moved to tip of nose; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number Em9809), via an unspecified route of administration at single dose in the left arm on 04Feb2021 11:30 for covid-19 immunisation. Medical history included pituitary tumour. The patient had not been tested for COVID-19 prior and post the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included famotidine, paracetamol (TYLENOL), cabergoline, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). On 04Feb2021 12:15, the patient experienced numbness in chin, then lip area. Moved to tip of nose and then several hours later, left eyelid and area between my eyes was completely numb. No treatment required. The outcome of the events was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,UNK,FAMOTIDINE; TYLENOL; CABERGOLINE; VITAMIN D [ERGOCALCIFEROL],,Medical History/Concurrent Conditions: Pituitary tumor malignant,,,"['Hypoaesthesia', 'Hypoaesthesia eye', 'Hypoaesthesia oral']",1,PFIZER\BIONTECH, 1045640,NJ,79.0,F,"began to hallucinate; Dizzy; bed nightmare; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Expiration Date: May2021), via an unspecified route of administration on 31Jan2021 at 79-years-old at a single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing, shrunk a little from an unknown date and unknown if ongoing (""about 5'9 and I was always 5'10 but I think I shrunk a little""). Concomitant medications included nebivolol hydrochloride (BYSTOLIC) taken for blood pressure high from an unspecified date to an unspecified date (""I have blood pressure, high blood pressure. I am taking a blood thinner. I was taking the other one, but they told me to look the other one (BYSTOLIC). It (BYSTOLIC) is a new drug I would say.""). The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on an unknown date and experienced adverse event (""no problem, nothing happened, there were minor things here and there""). On an unspecified date in Feb2021, the patient began to hallucinate (medically significant), dizzy (non-serious), and bed nightmare (non-serious). The patient did not receive treatment due to the events; ""No, I just ignored it."" The clinical course was reported as follows: The patient stated, ""I took the virus vaccination shot (clarified as COVID 19 vaccine). The first one, there was no problem, nothing happened, there were minor things here and there. The second one I took was just this past Sunday. Something weird happened not right away, not the first day but probably it was second day, second or the third day, I am pretty sure I am not sure exactly, I think. I was not keeping track of all of that."" The patient began to hallucinate; and when she got out of her bed, she suddenly had a feeling that she should look back. The patient stated that she looked back and there was her deceased sister (who died 37 years ago; according to the patient) and her daughter who was still alive; both were looking at her. The patient further reported the following: ""They remained in my bed beside me. Okay, I ignored it and thought it was kind of funny because I know that my daughter is in (place name) and my sister is deceased. So, I am having a bed nightmare or something, so I ignored it. Then next thing it happened for a few days and then the dog that we just had euthanized, my daughter (name) had cancer and it was euthanized and what happened is, I was sitting on my sofa and I have seen the dog come out of my bedroom going to the bathroom but only the back of her and she disappeared. Then I spent the night at my other daughter's house and somewhere in the middle of the night I was awake in my something and I woke up and I looked over into my sistert's dining room and there was my brother standing there looking at me and there was two of his children sitting at the table also. I thought this is getting a little weird."" The patient reported that nothing like this happened before. The patient wanted to understand the event because she ""never had been dizzy from my drug, taking the drug (unspecified medication) that made me dizzy but that not the same thing what is going on here."" The clinical outcome of the events was unknown. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/31/2021,02/01/2021,1.0,UNK,BYSTOLIC,,Medical History/Concurrent Conditions: Blood pressure high; Body height decreased (about 5'9 and I was always 5'10 but I think I shrunk a little),,,"['Dizziness', 'Hallucination', 'Nightmare']",2,PFIZER\BIONTECH, 1045641,FL,72.0,M,"Bell's palsy - reactivate herpes simplex scars right eye; Bell's palsy - reactivate herpes simplex scars right eye; Bell's palsy - reactivate herpes simplex scars right eye; positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1284; Expiration date: 30Apr2021), via an unspecified route of administration in the right arm, on 23Jan2021 (at the age of 72-years-old) at a single dose for COVID-19 immunization. Medical history included high blood pressure (HBP) and COVID-19. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included unspecified medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunization and influenza vaccine (FLU) on 05Jan2021 for immunization. The patient experienced positive COVID-19 test on 27Jan2021 and Bell's palsy - reactivate herpes simplex scars right eye on 01Feb2021. The patient underwent lab tests and procedures which included COVID-19 nasal swab: positive on 27Jan2021. Therapeutic measures were taken as a result of Bell's palsy - reactivate herpes simplex scars right eye, which included ganciclovir (ZIRGAN). The clinical outcome of positive COVID-19 test was unknown and of Bell's palsy - reactivate herpes simplex scars right eye was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/27/2021,4.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure high; COVID-19,,,"['COVID-19', 'Drug ineffective', 'Facial paralysis', 'Herpes simplex', 'SARS-CoV-2 test', 'Scar']",2,PFIZER\BIONTECH, 1045647,,,M,"patient died from a flu shot; Initial information was received on 12-Feb-2021 regarding an unsolicited valid serious case from a consumer or non-health care professional via social media. This case is linked to case 2021SA056035. (same reporter) This case involves a male patient (reporter's father in-law) (age unspecified) who died (death), after he received INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination. On an unknown date, the patient died from a flu shot (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was also assessed as medically significant. It was unknown if the patient experienced any additional symptoms/events before death. It was unknown if there were laboratory data/results available. It was not reported if the patient received any corrective treatment before death. It was unknown if an autopsy was done. The cause of death was reported as, the patient died from a flu shot. At the time of reporting it was reported that, product name was not provided and it was reported via public post on the Sanofi flu shot campaign hence reporter assumed that the consumer was referring to the Sanofi flu vaccine. There will be no information available on the batch number for this case.; Sender's Comments: This was a poorly documented social media case received from involved a male patient (age unspecified) who died (death) after administration of INFLUENZA VACCINE. The time to onset is unknown. Further information regarding medical history, concomitant disease or risk factor, concurrent condition during vaccination, previous vaccination and tolerance, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient died from a flu shot",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],UNK,UNKNOWN MANUFACTURER,OT 1045651,FL,68.0,F,red swollen hot area on arm started approximately 2 days after vaccine. It is spreading up and down the arm and has spread around all sides. From shoulder to wrist.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/18/2021,2.0,UNK,,,Chronic Lymphocytic Leukemia Primary Immune Deficiency,,,"['Erythema', 'Peripheral swelling', 'Skin warm']",2,MODERNA,IM 1045652,NY,52.0,F,"12 hours after first dose of vaccine I had side effects of chills and fatigue 15 hours after second dose of vaccine I experienced chills, aches/pains, and could not sleep at all. The only relief was hot baths. With both vaccines I experienced dizziness and fatigue that is lingering well after both doses of vaccine were given. Dizziness comes and goes but is consistently happening daily.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/15/2021,4.0,UNK,Effexor 37.5mg Ramipril 5mg Vit. C 1000 mg Vit. D 5000mg,Dizziness from first vaccine and second dose of vaccine and is still a side effect happening daily,,Measles shot I reacted with minor case of measles,Codeine,"['Chills', 'Dizziness', 'Fatigue', 'Pain']",2,MODERNA,SYR 1045653,,42.0,F,"dizziness, HA, loss of consciousness, convulsive syncope",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,MIL,"Iron, vitamin C.",No illnesses,anemia,,NKDA,"['Computerised tomogram head normal', 'Dizziness', 'Haematocrit decreased', 'Haemoglobin decreased', 'Headache', 'Human chorionic gonadotropin negative', 'Loss of consciousness', 'Metabolic function test normal', 'Nitrite urine present', 'Platelet count increased', 'Syncope', 'Urine leukocyte esterase positive', 'White blood cell count normal']",UNK,MODERNA,IM 1045654,FL,69.0,F,Felt dizzy and lightheaded immediately after vaccination. As of 2/18/21 - 10:35 am client feels better with no symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PUB,no,no,,,no,['Dizziness'],UNK,PFIZER\BIONTECH,IM 1045655,,55.0,F,"Within ten minutes of having the first vaccine, I developed a strong metallic taste in my mouth. This subsided within approximately 2 hours. Seven days after having the first vaccine, I developed ?Covid arm? at the injection site. The area is red, swollen, and very itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/14/2021,02/14/2021,0.0,PVT,"Vitamin D, CoQ10, Multivitamin",None,None,,"Penicillin, erythromycin, and dietary allergy to egg","['Dysgeusia', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA, 1045656,WI,67.0,F,"Chest tightness developed on day 3, intensity varies but is present constantly and has increased this morning (02/22/2021). Unusual sensation on tongue. These are the same symptoms I had when experiencing an allergic reaction to Repatha in Oct/Nov 2020. Those symptoms subsided after a month.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/16/2021,3.0,PHM,Lorsartan 50 mg Metoprolol ER Succinate 100 mg Hydrochlorothiazide 25 mg Latanoprost drops Timolol drops,,"Hypertension, high cholesterol, glaucoma, digestive disorder being evaluated at Mayo Clinic, also being evaluated for moderate kidney disease at time of vaccination",,"Repatha, Statins, Indocin, Doxycycline, Penicillin, Sulfa, Adhesives Food intolerances to eggs, lactose, fructans and fructose","['Chest discomfort', 'Glossodynia']",1,MODERNA,SYR 1045657,FL,73.0,F,"After receiving her vaccine client stated that she feel a tingling sensation in the mid upper back area. Vital signs obtained by EMS. Bp 121/78, HR 82, O2 sat 97%, Blood sugar 120. Client states she feels better and discharged home by EMS.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,OTH,HTn meds,none,HTn,,nka,['Paraesthesia'],UNK,PFIZER\BIONTECH,IM 1045718,NY,,F,"ability to regulate their diabetes with insulin was negatively affected; This is a spontaneous report from a contactable consumer. This consumer reported for an 80-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via unknown route of administration, on unknown date as a single dose for COVID-19 immunization at Nursing Home/Senior Living Facility. Relevant medical history and concomitant medications were unknown. Patient was not pregnant at time of vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination or if patient received any other vaccines within 4 weeks prior to the COVID vaccine. On unknown date, after receiving the COVID-19 vaccine, it was reported that the patient's ability to regulate her diabetes with insulin was negatively affected. The adverse event resulted in the doctor or other HCP's office/clinic visit. The outcome of the event was unknown. It was unknown if the patient received any treatment for the event. It was not known that since the vaccination, the patient had been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Diabetes mellitus inadequate control'],1,PFIZER\BIONTECH, 1045719,OK,44.0,F,"Shot 2-Nausea; vomiting; couldn't eat or drink; headache; skin pain; This is a spontaneous report from a contactable other HCP. A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Jan2021 18:00 (at the age of 44 years old) at single dose for covid-19 immunisation. Medical history included vestibular problems, allergies Cipro, migraines, concussion, all from an unknown date and unknown if ongoing. Concomitant medication included budesonide (BUDES), levocetirizine dihydrochloride (XYZAL), montelukast sodium (SINGULAIR), nortriptyline, olopatadine. The patient previously took cipro [ciprofloxacin] and experienced allergies. Patient also had BNT162B2 dose 1 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) lot unknown, on 02Jan2021 at 11:45 AM on left arm. The patient did not have any other vaccines in four weeks. The patient has not had covid-19 prior to vaccination. The patient experienced "" Shot 2-Nausea, vomiting, headache, skin pain, couldn't eat or drink"" on 23Jan2021 09:00 with outcome of recovering. The events resulted patient in Emergency room/department or urgent care. Patient was also received IV fluids, nausea medication, 2 pain medications for headache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Jan2021. Therapeutic measures were taken as a result of the events. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Nausea, Vomiting, and Eating disorder cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/23/2021,1.0,PVT,BUDES; XYZAL; SINGULAIR; NORTRIPTYLINE; OLOPATADINE,,Medical History/Concurrent Conditions: Concussion; Migraine; Vestibular disorder,,,"['Eating disorder', 'Headache', 'Nausea', 'Pain of skin', 'SARS-CoV-2 test', 'Vomiting']",2,PFIZER\BIONTECH, 1045720,DE,68.0,F,"Chest pains by heart once in the car; Itching by neck, shoulders, upper arms, legs, back; Throat closed up a bit; Sore upper left arm at injection site; Headache; Fatigue; Later on sharp pains in left calf upon walking; Numbness in left facial cheek and left side of tongue; Numbness in left facial cheek and left side of tongue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included allergies or hypersensitivity. Concomitant medication was not reported. The patient was not pregnant at the time of vaccination. The patient was vaccinated at a health facilty. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received second dose of varicella zoster vaccine (lot number and expiry date not reported) on 18Jan2021 at single dose for immunization. Five minutes after first shot of Pfizer Covid 19 vaccine, on 02Feb2021 13:35, it began itching by neck, shoulders, upper arms, legs, back; throat closed up a bit. The patient was administered 50 mg Benadryl, but itching continued. The patient had sore upper left arm at injection sight. They waited at the vaccination facility under care of 3 nurses for one hour. The patient was offered Epi-pen, but did not administer Epi-pen. The patient's husband drove her home. She had chest pains by heart once in the car. The patient had headache, fatigue, and later on sharp pains in left calf upon walking, numbness in left facial cheek and left side of tongue and difficulty swallowing. Clinical outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,SCH,,,Medical History/Concurrent Conditions: Allergy,,,"['Angina pectoris', 'Dysphagia', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Pain in extremity', 'Pruritus', 'Throat tightness', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1045721,MN,54.0,F,"inability to multitask, difficultly with problem solving, significant reduction task completion; Slow mental processing; reduced concentration; significant reduction in memory; dense Brain fog set in; This combined with an increasing pressure at the center of my head pushing out.; This is a spontaneous report from a contactable nurse (patient). A 54-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiration date: unknown), via an unspecified route of administration left arm on 26Jan2021 14:00 at a single dose for covid-19 immunization. Medical history included low back pain, and allergy to peanuts, gluten and nickel. Concomitant medication included vitamin b complex (VITAMIN B COMPLEX), egcg (EGCG), colecalciferol (VITAMIN D) and vitamin c [ascorbic acid] (VITAMIN C). The patient did not receive other vaccine in four weeks. The patient previously took ketorolac tromethamine (TORADOL) but had allergies. The patient recieved her most recent COVID-19 vaccine in her workplace clinic. On 26Jan2021 05:30 PM (reported as 3.5 hours after the vaccination), the patient had a dense brain fog set in, slow mental processing, reduced concentration, inability to multitask, difficultly with problem solving, significant reduction in memory and task completion. This has remained unchanged for 8 days. This combined with an increasing pressure at the center of her head pushing out. The patient reported that she received treatment for the adverse events and the events resulted in a doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included covid-19 test with negative results on an unspecified date. The outcome of the events was not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of mental impairment / mental disorders cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,WRK,VITAMIN B COMPLEX; EGCG; VITAMIN D [COLECALCIFEROL]; VITAMIN C [ASCORBIC ACID],,Medical History/Concurrent Conditions: Gluten sensitivity; Low back pain; Nickel sensitivity; Peanut allergy,,,"['Bradyphrenia', 'COVID-19', 'Disturbance in attention', 'Feeling abnormal', 'Head discomfort', 'Memory impairment', 'Mental impairment']",1,PFIZER\BIONTECH, 1045722,CA,46.0,F,"Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) issue is my throat, I feel like I have something (stuck) in my throat; I feel like I can't breathe normally; I can't speak; I do not feel well/I feel terrible/I feel isolated; I have pain in my body; I could hardly stand up/I did not got to work; Feel an itch, like an allergy, it was not a rash, just an urge to scratch me; Feeling dizzy; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that she received the COVID-19 vaccine at a hospital, patients were allowed to stay for 30 minutes, then they were released. After she left the hospital she started to feel an itch, like an allergy, it was not a rash, just an urge to scratch herself. She started feeling dizzy, nauseous, and a headache. Yesterday (02Feb2021), she could hardly stand up. Today (03Feb2021) she did not got to work, she do not feel well, she have pain in her body, fever and chills. The (most serious) issue was her throat, she feel like she have something (stuck) in her throat, she can't speak, she feel like she can't breathe normally. She haven't felt well at all, today is the 3rd day after receiving the vaccine and she couldn't go to work, she was nervous because she was fine (before receiving the vaccine). She does not want to go out because she feel very tired and dizzy, she was afraid of falling down in the street and getting hurt, she can hardly walk and she feel tired, experienced fatigue and sore throat. She have a cold, she feel terrible. she feel isolated and afraid. She will have to go to the hospital, if she cannot breathe well. Outcome of the events was unknown. Information about Lot/batch no has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,PVT,,,,,,"['Chills', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Gait disturbance', 'Headache', 'Loss of personal independence in daily activities', 'Malaise', 'Nasopharyngitis', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pruritus', 'Pyrexia', 'Sensation of foreign body', 'Speech disorder']",1,PFIZER\BIONTECH, 1045728,,20.0,F,"Local Redness of Swelling 50 to 120 mm, but not below the elbow. Itching but no other symptoms reported. 50mgs diphenhydramine given IM Right Arm. Observation started for 60 mins. All symptoms subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,MIL,Nexplanon,no,no,,no,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA,IM 1045729,FL,71.0,F,"Attacked all joints. Could BARELY walk, move head, use hands( started 8pm stop 9am). Excessively freezing (8pm-7am). Fever(101.3). Nausea (8:30pm - 2am). Diarrhea (second day - (lasted 6hrs).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,OTH,"Metoprolol ER; Levothyroxine; Esomeprazole; Sertraline,; Esomeprazole; Hydrochloride; Meloxicam; Centrum Silver, OTC; Nexium, OTC; Allegra, OTC",None,Arthritis Blood Pressure,,All ?Caines? when given large amounts,"['Arthropathy', 'Diarrhoea', 'Feeling cold', 'Gait inability', 'Joint swelling', 'Musculoskeletal stiffness', 'Nausea', 'Pyrexia']",2,MODERNA, 1045730,DE,29.0,M,"Patient was injected with 1 syringe that was believed to be empty. This was recognized by patient and the shot administrator. Immediately after, decision was made to re-administer vaccine. A second injection was then performed, the second time with Moderna COVID vaccine 0.5 mL. Patient was counseled",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,MIL,,,,,,"['Product dose omission issue', 'Syringe issue']",2,MODERNA,IM 1045731,FL,25.0,F,"After receiving the vaccine client stated shat she feels dizzy. Vital signs obtained by EMS Bp 113/78, O2 sat 100%, Blood sugar 118. Client states she feels better. Client discharged home by EMS. Client advised to call EMS if symptoms worsen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,OTH,"Asthma, anemia meds",none,"Asthma, anemia, SC trait",,"PCN, sulphur",['Dizziness'],1,PFIZER\BIONTECH,IM 1045732,AZ,56.0,F,I have been dizzy and my head feels cloudy and I can't stand up well without falling over.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,OTH,none,none,melanoma migraine headaches,Fall of 2018 Shingles Vaccine I developed a high fever and body aches.,none,"['Dizziness', 'Dysstasia', 'Fall', 'Feeling abnormal']",1,PFIZER\BIONTECH, 1045733,FL,93.0,F,Pt. in tent 23 at 2:05 pm at observation line. Complained of right eye. Paramedic assessed the pat. Once symptoms subsided pt. was released to leave.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,UNK,"lorozapan, iostatin",,"HTN, arthritis",,nka,['Unevaluable event'],1,PFIZER\BIONTECH,IM 1045734,MI,60.0,M,"headache, sweats, nausea (feeling)",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/19/2021,1.0,PUB,multi-vitamin,None,None,,None,"['Headache', 'Hyperhidrosis', 'Nausea']",2,MODERNA,IM 1045735,MA,29.0,F,"Around 5:30 PM I began experiencing normal symptoms like headache and muscle ache. At 8:15 PM I began to feel light headed, nauseous, and short of breath. Around 8:20 I needed to lay on the floor to prevent myself from fainting. My eyes were rolling back because I was borderline unconscious. I felt like I had no control of my body and had to go to the bathroom. For around 15 minutes I was on the floor convulsing, shaking as if I had chills and my muscles were involuntarily tensing. My pulse was extremely low. After the convulsions stopped I remained on the floor an additional 15 minutes. Around 8:45 PM I was able to return into my bed with assistance. My nauseous remained and I began experiencing chills. I slept on an off the entire night. At about 1 AM what I suspect was a fever began to break and I was extremely sweaty. For the following day I experienced exhaustion and muscle soreness. I am still experiencing exhaustion. I recognize a bulk of my symptoms were normal but the convulsions, losing consciousness, and inability to control my body seemed worth reporting.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,UNK,"Multi vitamin, altavera birth control, fluticasone propionate nasal spray",None,None,,Skin sensitivity to some topical creams Wheat sensitivity,"['Chills', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Gaze palsy', 'Headache', 'Heart rate decreased', 'Hyperhidrosis', 'Myalgia', 'Nausea', 'Seizure']",2,MODERNA,SYR 1045736,MA,57.0,M,"Painful itching rash left arm, torso . Nerve pain left arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/10/2021,1.0,OTH,Bystolic,No,Hypertension,,Epinephrine?tachycardia,"['Neuralgia', 'Pain in extremity', 'Pruritus', 'Rash']",2,MODERNA,SYR 1045737,IN,52.0,M,"Nausea, vomiting, headache, chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PVT,"Rosuvastatin, 5MG andLisinopril, 5MG",None,Elevated blood pressure (without medication),,None,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 1045738,PA,67.0,F,"Large, red, warm, itchy rash at vaccination site on left arm appeared on about 2/12/21. Contacted PCP, she suggested I see an allergist to be safe, met with Dr. on 2/18/21, he prescribed a cortisone cream to use immediateley. He also prescribed prednisone to use after second vaccine if reaction was worse, and an epinephrine auto-injector in case of severe reaction. He also suggested switching arms. Redness and itch have finally faded to almost nothing as of 2/22/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/12/2021,7.0,OTH,"Ibuprofen, Vit D, biotin",none,pain in hip joint,,none,"['Rash erythematous', 'Rash pruritic', 'Vaccination site reaction', 'Vaccination site warmth']",1,MODERNA, 1045739,FL,55.0,F,"Days 15 persistent 2"" red circle at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/17/2021,10.0,PHM,,,,,,['Injection site erythema'],1,MODERNA,IM 1045740,NY,66.0,F,"tennis ball size hard lump with itching at injection site, sore and hot to the touch 7 days after 1st vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/13/2021,02/21/2021,8.0,PHM,"lisinopril, liothyronine, vit D",none,,,,"['Injection site mass', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",UNK,MODERNA,IM 1045741,FL,66.0,F,Day 8 itching at injection site Day 9 red raised warm tender lump at injection site resolved over 48 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,02/02/2021,8.0,PHM,None,None,None,,Sulfa,"['Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 1045742,PA,82.0,F,Redness and itching shot site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,PHM,"Citalopram, lorazepam, metoprolol, losartan, multi vitamin, multi collagen protein",None,None,,None,"['Injection site erythema', 'Injection site pruritus']",UNK,MODERNA, 1045743,IA,47.0,F,"?Moderna COVID-19 Vaccine EUA? Rash, itching and warmth at and around the injection sight.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/20/2021,8.0,SCH,Venlafaxine,,,,,"['Injection site pruritus', 'Injection site rash', 'Injection site warmth']",UNK,MODERNA,SYR 1045744,PA,55.0,F,"nausa, aches, headache, tired",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,SCH,Lisinopril 10 mg - Metoprolol 50 mg - Glimepiride 1 mg - Metformin 500 mg,none,diabetic,,None,"['Fatigue', 'Headache', 'Nausea', 'Pain']",1,MODERNA,SYR 1045745,MI,78.0,F,Low grade fever which reached 99.8 degrees joint ache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,Levothyroxine 100 MCG Nifedipine ER 30 MG Pravastatin 40 MG Celecoxib 100 MG Vitamin D3 2000,None,Hypothyroidism High blood pressure Arthritis,,Penicillin Sesame Aspirin Tylenol,"['Arthralgia', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 1045746,,35.0,M,"Mild headache, lasted only 2 hours. Injected arm was sore starting 3 hours after injection until the next day at 5pm. (pain comparison, felt bruised)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,MIL,none,none,none,,none,"['Contusion', 'Headache', 'Injection site pain']",1,MODERNA,SYR 1045747,MA,0.08,U,"Nausea, fever, chills, body aches 48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,WRK,"Benadryl, Tylenol",,asthma,,peanut allergy,"['Chills', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,SYR 1045748,NH,61.0,F,"25 minutes after the vaccine was given I noticed hives on my arms and chest and my throat was tight. I went to urgent care, they administered iv Benadryl and pepcid. this did not stop the reaction, so they gave me an EpiPen IM and sent me to the hospital by ambulance. At the hospital, I was given Solu-Medrol IV, observed for about 4 hours, and sent home with prescriptions for 10 days of pepcid and Claritin and 4 days of prednisone. The allergic symptoms have not come back as of this reporting.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,WRK,Duloxetine 60 mg PO daily Omeprazole 20 mg PO daily Vitamin D3 2000 IU PO daily Valium 500 mg PO daily Ezetimibe 10 mg PO daily,None,Fibromyalgia Hypercholesterolemia Osteoarthritis Vitamin D deficiency Obstructive sleep apnea,Hives,IVP dye Latex Bananas Pineapple,"['Throat tightness', 'Urticaria']",2,MODERNA,IM 1045749,MO,34.0,M,Soreness in the back started on 2/5/2021 and eventually moved to the abdominal area on 2/12/2021. Went to the doctor and got a CT scan and found an Acute right common iliac vein and infrarenal IVC thrombus. Many blood tests were run and no common factors were located to cause the thrombus.,Not Reported,,Yes,Not Reported,,Not Reported,U,01/30/2021,02/05/2021,6.0,PUB,None,None,None,,Vicodine Family,"['Abdominal pain', 'Antithrombin III', 'Back pain', 'Blood immunoglobulin G normal', 'Blood immunoglobulin M', 'Blood immunoglobulin M normal', 'Blood test normal', 'C-reactive protein normal', 'Computerised tomogram abdomen', 'Computerised tomogram pancreas normal', 'Full blood count normal', 'Hepatic cyst', 'Hepatic lesion', 'May-Thurner syndrome', 'Metabolic function test', 'Pelvic venous thrombosis', 'Protein C', 'Protein S normal', 'Prothrombin level normal', 'Scan with contrast', 'Spleen scan normal', 'Thrombin-antithrombin III complex normal']",1,PFIZER\BIONTECH,IM 1045750,MN,70.0,M,"dizziness, hypotensive, nausea, tremors, muscle aches, light headed",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/18/2021,02/19/2021,1.0,OTH,unknown,,"CAD, HCV",,NKA,"['Dizziness', 'Hypotension', 'Myalgia', 'Nausea', 'Tremor']",2,MODERNA,IM 1045751,,63.0,M,"Got the 2nd dose of Corona Vaccine Moderna at 12:45pm yesterday - at 6p, started to feel weak/dizzy - then this am on 2/22/21 at approx 6:30, pt had a syncopal episode with preceding dizziness, denies cp/fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Asthenia', 'Dizziness', 'Syncope']",UNK,MODERNA, 1045752,FL,68.0,F,Pt. in tent 23 at 2:05 pm at observation line. Complained of light headed and increased blood pressure. Paramedics assessed pt. They monitored her until her symptoms subsided. Pt. was released. Husband drove her home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,UNK,"netformin, Statin",,OM - HTn,,,"['Blood pressure increased', 'Dizziness']",1,PFIZER\BIONTECH,IM 1045753,NH,61.0,F,"I noticed that I had hives on my right forearm. I took 25 mg of benadryl, and the hives went away. This occured at 10:00 PM, approximately 12 hours after the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/23/2021,0.0,PUB,Duloxetine 60 mg PO daily Omeprazole 20 mg PO daily Vitamin D3 2000 IU PO daily Valium 500 mg PO daily Ezetimibe 10 mg PO daily,None,Fibromyalgia Osteoarthritis GERD Hypercholesterolemia Vitamin D deficiency,,IVP dye Latex Bananas Pineapple,['Urticaria'],1,MODERNA,IM 1045755,NY,26.0,F,"Headache, fever, nausea. Dizziness, sore at injection site, chills and sweats, body ache, trouble sleeping. Took Advil for the fever and headache - helped with fever but not the headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,UNK,"Birth control pill, levothyroxine 100mg, Prozac 20mg, IBGard",,"Irritable bowel syndrome, hashimoto?s disease, anxiety, depression",Flu vaccine: soreness and tiredness,,"['Chills', 'Dizziness', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia', 'Sleep disorder']",2,MODERNA,SYR 1045757,FL,46.0,F,"Approximately 45 minutes after receiving the vaccine, patient returned reporting sharp back pain and headache. Patient denied difficulty breathing or swallowing. Denied chest pain or palpitations. Patient reports dizziness began 3 weeks ago. Glucose was 167.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,PVT,"Tamoxifen, Effexor, Tomamax, Novalog, Metformin","Diabetes, depression",,,"Perjeta, herceptin","['Back pain', 'Blood glucose normal', 'Dizziness', 'Headache']",1,PFIZER\BIONTECH,IM 1045760,NC,52.0,F,"Intermittent vibration (buzzing) in arch of right foot started approximately 23 minutes after the injection of the vaccine, and it is still occuring.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,MIL,Azelastine once daily Chewable Calcium with Vitamin D 650IU + 500IU Vitamin C 500mg Vitamin D 1000IU Vitamin B12 1000IU Fluticasone - 2 x 50 mcg/inh nasal spray two times per day Losartan - Treatment for High Blood Pressure 1 x 50 mg oral t,,"Allergic Rhinitis GERD Hidradenitis Suppurativa High Blood Pressure Hypothyroidism, After Partial Thyroid Removal Interstitial Cystitis Meniere's Disease Rosacea Sleep Apnea Vocal cord dysfunction",,Bactrim and singular,['Joint vibration'],2,MODERNA,IM 1045761,NY,67.0,F,Pain at injection site within hour after injection Felt spread down arm to elbow & up arm to neck It felt tender for a couple of weeks On 2/15/21 started feeling burning pain at back of injection arm & in scapula radiates down to wrist & small finger,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,PVT,Ibuprofen,none,sciatica - left leg,,none,"['Arthralgia', 'Injection site pain', 'Neck pain', 'Pain', 'Pain in extremity', 'Pain of skin']",1,MODERNA,IM 1045762,NJ,83.0,F,Diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/10/2021,6.0,PVT,Cardizem Cd 180mg-Pravastatin 10mg-vitamins Aspirin 325mg,None,mild hyperension,,None,['Diarrhoea'],2,PFIZER\BIONTECH,IM 1045763,FL,49.0,F,"Patient felt light headed. Denies SOPB, chest pain, palpitations, V/V, or visual changes.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,PVT,,,,,,['Dizziness'],1,PFIZER\BIONTECH, 1045764,MD,73.0,F,"Huge delayed rash one week after - about 8 to 10 long and ten inches wide. Itchy and raised. Day four of rash, has gotten slightly bigger. No fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,UNK,"Synthesis, cardia, irbesartin, vitamin d",None,High blood pressure. Graves disease,,"Penicillin. Sulfa, tetracycline","['Pruritus', 'Rash', 'Swelling']",1,MODERNA,IM 1045765,GA,51.0,F,"SORENESS AT THE SITE, MALAISE, FATIGUE, HEADACHE, SORE THROAT, CHILLS AND FEVER.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,PVT,"MOTRIN, TYLENOL, HERBAL TEA, ELDERBERRY",,HIGH BLOOD PRESSURE,,SULFA DRUGS,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Oropharyngeal pain', 'Pyrexia']",2,MODERNA,IM 1045766,KY,54.0,M,"The day after booster shot extremely lethargic, malaise, dry heaves and diarrhea with low grade fever. I'm now seven days out with continued extreme lethargy and diarrhea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/16/2021,1.0,PVT,flonase,none,none,,none,"['Diarrhoea', 'Lethargy', 'Malaise', 'Pyrexia', 'Retching', 'SARS-CoV-2 test']",2,MODERNA,IM 1045767,AZ,61.0,F,Moderna COVID-19 Vaccine - rash on torso,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,UNK,"Raloxefene, vitamin D, calcium",none,none,torso turned bright red after the Shingrex vaccine,penicillin and amoxycillin,['Rash'],1,MODERNA,IM 1045768,MD,66.0,F,Itchy sore red patch about 2 1/2 inches round on arm at injection site. Also experiencing itchy mouth which I get when I eat something I to which I am allergic.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/19/2021,10.0,PHM,Loratadine,None,None,Flu like symptoms following flu shot,"Strawberries, sulfa drugs","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Oral pruritus']",1,MODERNA,SYR 1045769,VT,70.0,F,"Dizziness that is continuing, fatigue, arm soreness, swelling of lymph nodes",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,PVT,"Synthroid, vitamin D, B-12",None,Hypothyroid,,None,"['Dizziness', 'Fatigue', 'Lymphadenopathy', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 1045770,,67.0,F,"103 fever, difficulty breathing, chest cough, not coherent",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/16/2021,02/22/2021,6.0,OTH,,herniated thoracic disk,lupus,,"sulfa drugs,","['Cough', 'Dyspnoea', 'Incoherent', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1045771,FL,75.0,F,"She felt hypotensive. She states that she felt that her BP was increasing. Average range is 160/170 systolic. Felt anxious prior to vaccine. Denied SOB, difficulty breathing, denied chest pain or dizziness. 15:35 VS 187/72 and HR 69. 16:17 VS 212/94 HR 71 RR 14 and o2 sat 100%. Brought patient to our express symptom management unit.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,PVT,,,,,,"['Anxiety', 'Hypotension']",1,PFIZER\BIONTECH, 1045772,NY,37.0,F,"Reported Fever 103F, fatigue, chills, sweats, and muscle aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/08/2021,02/08/2021,0.0,PVT,,,,,,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1045781,,,U,"Patient was given less than a quarter of the dose; A spontaneous report was received from a pharmacist concerning a unknown patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and patient was given less than a quarter of the dose. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly prophylaxis of COVID-19 infection. Reporter who was a pharmacist stated patient was given less than a quarter of the dose. Pharmacist was wondering if another dose should be given. This was the patient's second dose of the series. No further information was reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event was resolved.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273 (lot # unknown) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Incorrect dose administered'],1,MODERNA,OT 1045786,ME,67.0,M,"About ten days after the first dose I began to have ""brain fog"". When I arrived at the donor center to give a monthly platelet donation my blood pressure was extremely high, 184/104. My average blood pressure varies with an average of 135/80. Never above 150/90. It has stayed relatively high, though a late-day glass of red wine seems to bring the blood pressure lower.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/08/2021,02/18/2021,10.0,PUB,none,none,none,,none,"['Feeling abnormal', 'Hypertension']",1,MODERNA,IM 1045787,FL,75.0,F,"Hot, red, itchy front of upper arm from injection site to elbow",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/20/2021,3.0,UNK,"letrozole, calcium",none,none,red arm after shingrix vaccine,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",2,PFIZER\BIONTECH,SYR 1045788,NY,96.0,F,"Pt complains of experiencing bilateral burning from toes to ankles 2 days after receiving 2nd dose of Moderna. Plan per MD: trial 100mg gabapentin at bedtime; consider lab draw, B12 supplementation d/t low levels from previous blood draw",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/01/2021,,UNK,"Gabapentin 100mg capsule, mirtazapine 30mg tab, verapamil 40mg tab, eliquis 2.5mg tab, propafenone 150mg tab, pravastatin 10mg tab",,"chronic venous insufficiency, essential HTN, HLD, PAF, Varicose veins, Chronic idiopathic constipation, Non-ulcer dyspepsia, hypothyroidism, COPD, Bilateral Open-angle glaucoma, Anemia, Osteoporosis, Scoliosis, Anxiety & Depression, Primary insomnia",,"NKDA, NKFA",['Burning sensation'],2,MODERNA,IM 1045789,VA,65.0,F,Red Rash 3 inch circle raised hot to touch,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/21/2021,7.0,PHM,Atorvastatin Raloxifeine,none,"none, high cholesterol",,Dust,"['Rash erythematous', 'Rash papular', 'Skin warm']",1,MODERNA,SYR 1045790,NC,76.0,F,Immediate itch in the head and arm fifteen minutes after shot along with slight swelling of the lip. Then 2 weeks after 2nd dose the same itch has returned all over the body along with some open rashes on the skin.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/06/2021,0.0,PVT,None,"High blood pressure, arthritis, ear mennierre disease",,,Tramadol,"['Immediate post-injection reaction', 'Lip swelling', 'Pruritus', 'Rash']",2,PFIZER\BIONTECH,SYR 1045791,NM,54.0,F,"Covid arm 9 days following vaccine. Tenderness, itching, round red patch approx 2 inches in diameter at injection site. Injection site warm to the touch. Itchy arm and shoulder same side as injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/11/2021,02/20/2021,9.0,PHM,"Levoxyl, vitamin D, vitamin B, turmeric capsule",,"Hypothyroidism, unspecified autoimmune disorder, mild obesity, endometriosis",,,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth', 'Pruritus']",UNK,MODERNA, 1045792,FL,66.0,M,"Warm feeling bilateral to the legs. Itching to plantar left foot. VS 197/89 HR 114 at 13:38. VS at 13:46 150/78 HR 106. Denies SOB, palpitation, no N/V.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,PVT,,,,,,"['Feeling hot', 'Pruritus']",1,PFIZER\BIONTECH,IM 1045793,MI,41.0,F,"Runny nose, Body aches, fatigue, joint pains (diffuse), lymph node swelling of neck and axillary region on same side as vaccination given, muscle soreness and pain of chest wall on same side as vaccination given, felt hot and prickly all over but not measuring fever, nausea. Symptoms started late Friday night after vaccination and are ongoing still as of Monday after receiving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,OTH,"Tirosint, liothyronine, Singulair, folic acid, cetirizine, Vit D, multivitamin, Aviane (OCP)",Papillary thyroid cancer (considered stable post-surgically and post radioactive iodine treatment),"Papillary thyroid cancer, asthma, seasonal allergies, adenomyosis of uterus",,"Penicillin, ceftin, Flagyl, Zithromax, adenosine","['Arthralgia', 'Fatigue', 'Feeling hot', 'Lymphadenopathy', 'Musculoskeletal chest pain', 'Myalgia', 'Pain', 'Rhinorrhoea']",2,PFIZER\BIONTECH,IM 1045794,NY,66.0,M,"Severe chills & trembling, fever (101.5), nausea, , achiness, feeling of malaise, severe fatigue. Started 7 hours after vaccine administration, and lasted 15-16 hours, with ongoing residual fatigue - it was bad.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,SCH,"Alfuzosin, 10mg/day",none,none,,none,"['Chills', 'Fatigue', 'Malaise', 'Nausea', 'Pain', 'Pyrexia', 'Tremor']",2,PFIZER\BIONTECH,IM 1045795,MI,95.0,F,"Sore arm, reddened site 4 cm square 2 days after. Redness continues 6 days after",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/17/2021,2.0,UNK,Tylenol 500 taken every 6-8 hours x3,None,"Hypertension, osteoporosis, dementia, stage 3 kidney disease",,NKA,"['Erythema', 'Pain in extremity']",2,MODERNA,SYR 1045796,ME,44.0,F,"Patient came to us with complaints of her heart racing, feeling like she needed ""fresh air"" and slight itch to throat. NP and RN on sight assessed patient and had her sit in reclining chair with some water. 50 mg of Benadryl were administered orally at 1630. By 1720 patient was feeling better and her husband came to pick her up",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,,,,,,"['Palpitations', 'Throat irritation']",2,PFIZER\BIONTECH,IM 1045797,NY,67.0,M,"Neck ache, upper body muscle ache, severe headache/sinus ache, production of mucus, fever of 100 on and off. This was from 12 hours after vaccine, and lasted 24 hours. Tylenol was effective to reduce both headache and fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/21/2021,1.0,OTH,Atrovastatin 10mg Tamsulosin .4 mg Multivitamin Anoro Ellipta inhaler 62.5mcg/25mcg,none,COPD,,Iodine,"['Headache', 'Myalgia', 'Neck pain', 'Pyrexia', 'Secretion discharge', 'Sinus pain']",2,MODERNA, 1045798,FL,80.0,F,"Extreme stomach distress: Nausea, diarrhea, stomach unsettled/growling, afraid to eat. Gradually better by 02/21/2021 (light eating all day) and feeling pretty well today (02/22/2021)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/21/2021,3.0,PHM,Tenormin (Atenolol) 12.5 mg daily,,"need knee replacements, low bone density",,"-mycin drugs, Aspirin sensitivity - bleeding issue","['Abdominal discomfort', 'Diarrhoea', 'Gastrointestinal sounds abnormal', 'Hypophagia', 'Nausea']",2,PFIZER\BIONTECH,SYR 1045799,GA,39.0,F,The lymph node in my left armpit is tender and causing some soreness/discomfort.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/22/2021,6.0,PHM,none,none,none,,none,"['Axillary pain', 'Lymph node pain']",UNK,MODERNA,SYR 1045800,FL,16.0,F,"Itching and rash to the injection site, left deltoid. Down left arm shoulder and chest. After a few minutes patient was stable and sent home after monitoring patient. Benadryl was administered at 12:17pm. Patient advised to take Benadryl prior to 2nd dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,PVT,,,,,"Amoxicillin, Ampicillin, codeine, Demerol, dilaudid, doxycycline, motrin, penicillin, Zithromax, omnicet","['Injection site pruritus', 'Injection site rash', 'Rash']",1,PFIZER\BIONTECH,IM 1045801,NJ,60.0,F,Injection site very sore continues ; injection site swollen continues; extreme muscle ache throughout body; sore throat the morning after injection; temperature 101 first day after; second day 99 (normal 98.4); third day 98.9.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PVT,Sertraline; Simvastatin; Ramipril; Humalog.,None,Type1 Diabetes x50 years Anxiety,,NKA and NKDA,"['Body temperature increased', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Oropharyngeal pain']",2,MODERNA,SYR 1045803,VA,89.0,F,"Patient was found with no pulse no heart rate by a staff member around 11 pm. Earlier that day seen by myself for fatigue, sorethroat, nausea.",Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/15/2021,0.0,SEN,"atorvastatin, Lisinopril, Lasix, Zoloft, timolol",symptoms of nausea and sorethroat 1 week prior to vaccine,"Hypertension, hyperlipidemia, dementia, lymphedema, glaucoma",,sulfa,"['Cardiac arrest', 'Condition aggravated', 'Death', 'Fatigue', 'Nausea', 'Oropharyngeal pain', 'Pulse absent', 'Urine analysis']",2,PFIZER\BIONTECH,IM 1045804,IL,57.0,F,"Hives primarily on left side of face/cheek. Just observed, about 4 hours after it diminished 75%, I took one Benadryl at bedtime just in case, next morning it was gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,SCH,"Allegra, flonase",,Chronic sinus,,Sulfa based medications,['Urticaria'],1,PFIZER\BIONTECH,SYR 1045805,MD,42.0,F,Generalized Pruritic hives,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,PVT,Maxzide 25 mg Albuterol inhaler,None,"Asthma, Hypertension",,No known allergies to foods or drugs,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH, 1045806,NC,70.0,F,"One side effect I still have, I now have very high blood pressure. I?ve been to my cardiologist, wore a heart monitor for 5 days, follow up appointment in 2 weeks. I?ve quadrupled my BP dosage, blood pressure is still high.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/1921,01/01/2021,36525.0,UNK,Metoprolol,None,None,,Many allergies,"['Electrocardiogram ambulatory', 'Hypertension']",2,MODERNA,IM 1045807,NJ,25.0,F,Syncope,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/22/2021,1.0,OTH,,,,,,['Syncope'],2,PFIZER\BIONTECH, 1045808,NY,65.0,F,After 5-7 days I noticed a mottling in the arm that was vaccinated and veins in that arm appeared pronounced and bluish and sore arm noticed after a hot shower and disappeared about an hour later. This reaction persisted several days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/11/2021,6.0,PVT,"Synthroid 88mcg,Allegra,Emergen-C Plus","Autoimmune Thyroid Desease,Mild Roscea, Dupytrens Disease",See above,,Minimal seasonal Allergy,"['Injection site pain', 'Livedo reticularis']",1,MODERNA,IM 1045809,OK,41.0,M,"Approximately 14 hours of shot I suffered 3 partial seizures (20-30 second duration) in short succession with 5-10 minutes of each other. I was awake and aware during all 3 events. After 3rd, I had a severe headache lasting 24-36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,MIL,aspirin / valtrex / Vitamin C / Lisinopril,None,High Blood Pressure (controlled),,none,"['Headache', 'Partial seizures']",1,MODERNA,IM 1045810,MI,62.0,M,Right hip leg muscles and joint pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/17/2021,2.0,UNK,None,Gout,Gout,,None,"['Arthralgia', 'Hip arthroplasty', 'Myalgia', 'Pain in extremity']",1,MODERNA,SYR 1045811,NC,34.0,F,Extreme muscle pain. Twisting and tightening feeling. Unable to relax. swelling at injection site and bruising,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PVT,"Latuda, Amitriptyline",,,"hives, 25, 9/2012, flu vaccine","Percocet, yellow dye, latex, flu vaccine","['Injection site bruising', 'Injection site swelling', 'Myalgia']",2,PFIZER\BIONTECH,IM 1045812,FL,71.0,F,"Patient began coughing immediately after sitting down for her observation. Patient had a dry cough. Vitals every 5 minutes. No acute distress, lungs were clear.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/17/2021,01/17/2021,0.0,PVT,,,,,,['Cough'],1,PFIZER\BIONTECH,IM 1045813,LA,46.0,F,"6 days after vaccination, large, red, hot, itchy painful swelling on shoulder at vaccine site. Consistent with online reporting of ""covid arm""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/21/2021,6.0,PHM,"sumatriptan, vitamin E, vitamin A, zinc, magnesium, iron, vitamin C, multivitamin",no,migraine,,no,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 1045814,FL,78.0,F,"Quarter sized inflammation next to the injection site. Round, swollen, painful",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/22/2021,2.0,PUB,Lazopram,None,High blood pressure,,None,"['Injection site inflammation', 'Injection site pain', 'Injection site swelling']",2,MODERNA,SYR 1045815,LA,63.0,M,"vomiting, diarrhea, chills and body aches. Treatment: Phenergan, advil Time Course: 36 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,OTH,"atenolol, fiber con, protonix, baby aspirin, crestor, vitamin D3, vitamin C, ocuvite 50+, chlorphen-phenylephrine",None,High blood pressure,,lipitor,"['Chills', 'Diarrhoea', 'Pain', 'Vomiting']",1,PFIZER\BIONTECH,SYR 1045816,MI,69.0,F,"AFTER RECEIVING THE VACCINE, SHE COMPLAINED OF BEING TIRED. ONSITE EMS RESPONDED. HER VITAL ARE BELOW. SHE REFUSED ADDITIONAL EVALUATION AND CARE.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/20/2021,0.0,PUB,,,,,,['Fatigue'],1,MODERNA,IM 1045817,MD,77.0,F,"Tingling and numbness in face, could not move face, resolved after a day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,OTH,"Carvedilol, Lisinopril, Atorvastatin, Amlodopine, Xarelto",None,Atrial fibrillation,,None,"['Facial paresis', 'Hypoaesthesia', 'Paraesthesia']",UNK,PFIZER\BIONTECH,SYR 1045818,FL,68.0,M,"Patient reported chest discomfort and itchiness, resolved within 5 min.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,PVT,,,,,,"['Chest discomfort', 'Pruritus']",1,PFIZER\BIONTECH,IM 1045819,WV,74.0,F,Had seizure 2/5/21 . Does have dx of seizures disorder,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/05/2021,1.0,SEN,INVanz Solution Reconstituted 1 GM (Ertapenem Sodium) Inject 1 gram intramuscularly one time a day for ESBL/EColi in urine OXcarbazepine Suspension 300 MG/5ML Give 400 mg by mouth one time a day related to GENERALIZED IDIOPATHIC EPILEPSY,"HEMIPLEGIA AND HEMIPARESIS FOLLOWING CEREBRAL INFARCTION AFFECTING LEFT NON-DOMINANT SIDE SLP Acute Neurologic 2/3/2021 Principle Admitting Dx 2/3/2021 update G40.309 T GENERALIZED IDIOPATHIC EPILEPSY AND EPILEPTIC SYNDROMES, NOT INTRACTABLE, WITHOUT STATUS EPILEPTICUS Medical Management 2/1/2021 Secondary 1 Admission 2/1/2021 update I25.10 ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS Cardiovascular and Coagulations 2/1/2021 Secondary 2 Admission 2/1/2021 update I48.0 PAROXYSMAL ATRIAL FIBRILLATION Cardiovascular and Coagulations 2/1/2021 Secondary 3 Admission 2/1/2021 update I10 ESSENTIAL (PRIMARY) HYPERTENSION N/A, not an acceptable Primary Diagnosis 2/1/2021 Secondary 4 Admission 2/1/2021 update E78.5 HYPERLIPIDEMIA, UNSPECIFIED Medical Management 2/1/2021 Secondary 5 Admission 2/1/2021 update G45.9 TRANSIENT CEREBRAL ISCHEMIC ATTACK, UNSPECIFIED SLP Medical Management 2/1/2021 Secondary 6 Admission 2/1/2021 update E02 SUBCLINICAL IODINE-DEFICIENCY HYPOTHYROIDISM Medical Management 2/1/2021 Secondary 7 Admission 2/1/2021 update I27.20 PULMONARY HYPERTENSION, UNSPECIFIED Cardiovascular and Coagulations 2/1/2021 Secondary 8 Admission 2/1/2021 update M62.81 T MUSCLE WEAKNESS (GENERALIZED) N/A, not an acceptable Primary Diagnosis 2/12/2021 Secondary Other During Stay 2/12/2021 update R26.2 T DIFFICULTY IN WALKING, NOT ELSEWHERE CLASSIFIED N/A, not an acceptable Primary Diagnosis 2/12/2021 Secondary Other During Stay 2/12/2021 update R13.12 T DYSPHAGIA, OROPHARYNGEAL PHASE N/A, not an acceptable Primary Diagnosis 2/12/2021 Secondary Other During Stay 2/12/2021 update R48.8 T OTHER SYMBOLIC DYSFUNCTIONS N/A, not an acceptable Primary Diagnosis 2/12/2021 Secondary Other During Stay 2/12/2021 update F33.1 MAJOR DEPRESSIVE DISORDER, RECURRENT, MODERATE Medical Management 2/5/2021 Secondary Other Admission 2/5/2021 update G20 T PARKINSON'S DISEASE Acute Neurologic 2/1/2021 Secondary Other Admission 2/1/2021 update F03.90 T UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE Medical Management 2/1/2021 Secondary Other Admission 2/1/2021 update R55 SYNCOPE AND COLLAPSE Medical Management 2/1/2021 Secondary Other Admission 2/1/2021 update Z85.42 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF OTHER PARTS OF UTERUS N/A, not an acceptable Primary Diagnosis 2/1/2021 Secondary Other Admission 2/1/2021 update L80 VITILIGO N/A, not an acceptable Primary Diagnosis 2/1/2021 Secondary Other Admission 2/1/2021 update Z86.16 PERSONAL HISTORY OF COVID-19 N/A, not an acceptable Primary Diagnosis 2/1/2021 Secondary Other Admission 2/1/2021 update Z95.0 PRESENCE OF CARDIAC PACEMAKER N/A, not an acceptable Primary Diagnosis 2/1/2021 Secondary Other Admission 2/1/2021 update N17.9 ACUTE KIDNEY FAILURE, UNSPECIFIED Medical Management 2/1/2021 Secondary Other Admission 2/1/2021 update R06.09 OTHER FORMS OF DYSPNEA N/A, not an acceptable Primary Diagnosis 2/1/2021 Secondary Other Admission 2/1/2021 update Z87.440 PERSONAL HISTORY OF URINARY (TRACT) INFECTIONS N/A, not an acceptable Primary Diagnosis 2/1/2021 Secondary Other Admission 2/1/2021 update E87.6 HYPOKALEMIA Medical Management 2/1/2021 Secondary Other Admission 2/1/2021 update F41.1 GENERALIZED ANXIETY DISORDER Medical Management 2/1/2021 Secondary Other Admission 2/1/2021 update K21.9 GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS N/A, not an acceptable Primary Diagnosis 2/1/2021 Secondary Other Admission 2/1/2021 update I50.9 HEART FAILURE, UNSPECIFIED Cardiovascular and Coagulations 2/1/2021 Secondary Other Admission 2/1/2021 update D64.9 ANEMIA, UNSPECIFIED Medical Management 2/1/2021 Secondary Other Admission 2/1/2021 update K59.01 SLOW TRANSIT CONSTIPATION N/A, not an acceptable Primary Diagnosis 2/1/2021 Secondary Other Admission 2/1/2021 update Z90.710 ACQUIRED ABSENCE OF BOTH CERVIX AND UTERUS",,,"oranges, strawberries",['Seizure'],1,PFIZER\BIONTECH,IM 1045820,MI,52.0,F,Developed a raised red rash at injection site. It is itchy and about 7 inches in diameter,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/19/2021,11.0,UNK,Trazadone Rezilin,,,,Gadolinium,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash']",2,MODERNA,SYR 1045821,FL,51.0,M,"Chills, fatigue, body aches, headache, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,UNK,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Malaise', 'Pain']",2,MODERNA,IM 1045822,NJ,29.0,M,Fever (Sweats and Chills) - 6 hours Severe Headache - 12 hours Body Aches - 18 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,Pantoprazole,,Asthma,,,"['Chills', 'Headache', 'Hyperhidrosis', 'Pain', 'Pyrexia']",2,MODERNA,IM 1045823,OH,42.0,F,"Upper back rash and rash below injection site, low fever day 10.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/19/2021,8.0,WRK,Relpax as needed,,Migraine,,"Sulfa drugs, penicillin, zonismade, bactrum","['Injection site rash', 'Pyrexia', 'Rash']",1,MODERNA, 1045824,AZ,21.0,F,"Patient indicated she had tingling neck, throat, mouth. Provided oral diphenhydramine (Benadryl) 50 mg at 0625 and monitored. At approximately 0650 patient indicated the tingling was gone and she was ready to return to work. Vitals were WNL through this period. Patient worked for the medical hub, believed to be run by Contract employees. Her supervisor was notified of situation and cleared to return to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,OTH,,,,,,"['Paraesthesia oral', 'Pharyngeal paraesthesia']",UNK,MODERNA,IM 1045825,MD,43.0,F,"Non-stop body aches for the past 16 days. Headaches at least once per day lasting a few hours per day, without prior history of headaches, still occurring. Chills for 2 days afterwards. Constant fatigue since getting the vaccine. CDC will not accept my comments.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/06/2021,0.0,PVT,None,None,None,First COVID 19 vaccine had similar symptoms,None,"['Chills', 'Fatigue', 'Headache', 'Pain']",2,MODERNA,IM 1045826,PA,73.0,F,"Chills, headache, low grade fever, fatigue and muscle weakness and sore arm. Taking Tylenol. Symptoms lasted around 42 hours .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PUB,"Atenolol, crestor, singular",None,"High blood pressure, high cholesterol",Arm soreness,None,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 1045827,NC,69.0,F,"Redness, swelling, itchy and tender to the touch after 7 days of vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,PHM,Rosuvastatin calcium and Equate MultiVitamins,none,none,,Bees allergy,"['Erythema', 'Pruritus', 'Swelling', 'Tenderness']",1,MODERNA,SYR 1045828,WA,54.0,F,"fever, chills, headache, nausea, muslce, joint aches, fatiue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,WRK,"carbidopa/levodopa, duloxetine, multi vit, vit d",none,"Parkinsons, asthma",,"tramadol, vicoden, gabapentin, neurontin","['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 1045829,AL,44.0,F,"Flu symptoms: chills, fever, body aches, headache, cold sweats",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,SCH,"Hydrochlorothiazide, levothyroxine, lorsatan",N/a,"Asthma, high blood pressure, autoimmune disorder",,Penicillin,"['Chills', 'Cold sweat', 'Headache', 'Influenza like illness', 'Pain', 'Pyrexia']",1,MODERNA,SYR 1045830,IL,49.0,F,"Redness & soreness at injection site R forearm for 1 week. Felt generalized muscle aches and fatigue on 2/20- developed cold sore on mouth. Took famcyclovir. 2/21 Woke up with redness & soreness increased, site itched and area became swollen size of large grape. Armpit and neck on left side was sore with raise lymph nodes.-Took Tylenol and applied ice to arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,PHM,"Atorvastatin, Cytomel, Synthyroud, Buprion, Avalide, Clariton, oral contraceptive birth control",Na,"HTN, hyperlipemia, depression, hypothyroidism",,"Cephalosporin, Penicillin, Erythromycin","['Axillary pain', 'Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Lymphadenopathy', 'Neck pain', 'Oral herpes', 'Pain']",1,MODERNA,IM 1045831,MI,61.0,F,"AFTER RECEIVING THE VACCINE, SHE STARTED HAVING DIFFICULTY BREATHING. ONSITE EMS/PHYSICIAN RESPONDED. VITALS ARE BELOW. EMS WANTED TO TRANSFER HER TO EMERGENCY ROOM BUT SHE REFUSED AND WENT HOME AGAINST MEDICAL ADVICE.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/20/2021,0.0,PUB,"VENTOLIN INHALER, QVAR INHALER",,,,PENICILLIN AND SOME NARCOTICS,['Dyspnoea'],1,MODERNA,IM 1045832,AR,71.0,F,"patient states she received injection on 1/27/21 with no issues at time of injection. On 2/8/21 she noticed tenderness at site of injection, fine rash with redness, red streaks down the arm and heat noticed to area. States she has been putting ice packs and Benadryl cream to area. 2/12/21 PCP Dr notified of signs & symptoms per patient and also via me.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,02/08/2021,12.0,PHM,"K+, Losartan, Levothyroxine, Centrum Silver",Vertigo 1 week prior to vaccination,"Hypertension, thyroid condition, Atrial Fibrillation",,none,"['Injection site erythema', 'Injection site pain', 'Injection site rash', 'Injection site streaking', 'Injection site warmth']",1,MODERNA,IM 1045833,FL,51.0,F,"Chills, fever, body aches, headache, fatigue, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,UNK,None,None,Rheumatoid arthritis,,None,"['Chills', 'Fatigue', 'Headache', 'Malaise', 'Pain', 'Pyrexia']",2,MODERNA,IM 1045834,NC,48.0,F,"I have numbness on the left lower side of my face. It is faint, however, noticeably different from the right side with no symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/18/2021,2.0,PVT,"I am currently taking Diltiazem(240mg) for Hypertension since 2017. A week prior to the vaccination, I consumed two Clonidine(10mg) due to Blood Pressure(BP) being elevated.",No other illnesses reported.,"Other than the Hypertension diagnosis in December 2017, I do not have any other health conditions.",,"I have allergies to Penicillin and sulfur and currently taking allergy shots(monthly) via clinic, with Dr.",['Hypoaesthesia'],UNK,PFIZER\BIONTECH, 1045835,IA,64.0,M,"Headache, chills, and fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,UNK,None,None,None,,none,"['Chills', 'Headache', 'Pyrexia']",2,MODERNA, 1045836,TX,71.0,F,"about 30 to 40 minutes after shot on my way home. my lips, tongue, and throat was swelling. Lasted until after 5 pm . the next day through the following day i had burning on my tongue and mouth. Strange sensation. Slight weakness in my legs through Monday and then i was fine. On Monday i called my doctor and the doctor suggested that i go for my second shot and let them know of my reaction and let them decide if i should take my second shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/06/2021,0.0,OTH,"vitamins, fish oil, vitamin D and C, afadelfalic, magnesium citrate, buspirone,",,Chemo 2018-2019,,"penicillin, sulfa, codeine, rythamyasion, fentanyl,","['Lip swelling', 'Muscular weakness', 'Oral discomfort', 'Pharyngeal swelling', 'Swollen tongue', 'Tongue discomfort']",1,PFIZER\BIONTECH,SYR 1045837,FL,75.0,F,"Small red area for 6 days, faded small red area on 7th day, LARGER RED AREA ON 8TH DAY WITH ITCHING. This is 9th day and red area continues to enlarge with more itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,PHM,Eye Health Complex Dietary Supplement,none,none,,Bactrim,"['Erythema', 'Pruritus']",1,MODERNA,SYR 1045838,NJ,70.0,F,"I had no reaction after the first dose. However about 24 hours after the second dose my blood glucose levels remained elevated for about 48 hours, regardless of how much insulin I administered both via my pump (increasing basal and bolus rates) and MDI. The levels remained in the mid to upper 200s. With an average A1c in the high 5s and low 6s, this was unusual for me.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/14/2021,02/15/2021,1.0,OTH,"Insulin (Novolog), Accupril, Crestor, Synthroid, Vitamin D",,Type I Diabetes,Insulin resistance after a steroid injection...lasting about 2-3 days,Tetracycline,['Blood glucose increased'],UNK,MODERNA, 1045839,CT,58.0,F,"Rash covering arms, inner thighs, and stomach. I also had 20 hours of fever and weakness. But I know that the rash is not something I have seen reported. I'm writing this as I have it.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/22/2021,2.0,UNK,"Keppra XR 1500mg daily Synthroid 88mcg Sun, M, W, F, Sat 75mcg T, Th Atorvastatin 40mg daily Low dose aspirin 8mg daily",bacterial vaginitis 1 month prior,Underactive Thyroid (treated) Seizure disorder (treated) High cholesterol and atherosclerosis,,none,"['Asthenia', 'Pyrexia', 'Rash']",2,MODERNA,SYR 1045840,NJ,68.0,M,I started to have leg pain from foot to ankle and limbing just after the second dose I did xray and echo and found i have osteoarthritis any relation to the vaccine?,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,02/06/2021,29.0,OTH,only tylenol extra strength,blood pressure and gout and high cholesterol,,,none,"['Echocardiogram', 'Osteoarthritis', 'Pain in extremity', 'X-ray']",2,MODERNA, 1045841,AZ,31.0,F,"UNKNOWN WHICH VACCINE BRAND. Presented to the ED with chief complaint of a reported allergic reaction with onset at 0300 this morning. Patient states she woke up feeling like her ""airway was closing and her tongue was itching."" She reports she received the second dose of the COVID vaccine 2 days ago. Patient took 25 mg of Benadryl upon onset of symptoms, however symptoms persisted. She then took another 25 mg without improvement and decided to come to the ED before her symptoms became worse. Patient states she developed generalized myalgias and nausea after the first COVID vaccine; received diphenhydramine, prednisone, famotidine in ED and for discharge",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/28/2021,2.0,PVT,none,none,allergic rhinitis,,none,"['Myalgia', 'Nausea', 'Throat tightness', 'Tongue pruritus']",2,PFIZER\BIONTECH,IM 1045842,OH,88.0,M,A few days after the vaccination my father had a sore throat and slight cough. This progressed into pneumonia like symptoms and he died on 2/11/21.,Yes,02/11/2021,Not Reported,Yes,8.0,Not Reported,N,01/21/2021,01/24/2021,3.0,PVT,,,,,,"['Cough', 'Death', 'Oropharyngeal pain', 'Pneumonia']",1,PFIZER\BIONTECH, 1045844,NY,65.0,F,"Soreness, mild swelling and redness at injection site followed 5-7 days later, by mottling in the skin of both extremities, clavicle area and back of neck with prominence of veins in feet and upper extremities with temperature changes. This was accompanied by a prickling sensations. I got a sore inside my right nostril and a cold sore on right upper lip. The mottling and vein prominence continue intermittently still. Improving but not resolved entirely. Along with this, my eyes became intermittently itchy as if I had an allergic irritation. This has also completely resolved. I spoke with a relative who is a physician and he felt that I may have had a hypersensitivity cutaneous vasculitis reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/10/2021,6.0,PVT,"Synthroid, Emergen C Plus, Allegra",None,"Autoimmune thyroid disease, roscacea, dupytrens",,Mild seasonal,"['Eye pruritus', 'Feeling of body temperature change', 'Hypersensitivity vasculitis', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Livedo reticularis', 'Nasal discomfort', 'Oral herpes', 'Paraesthesia', 'Superficial vein prominence']",2,MODERNA,IM 1045845,SC,69.0,M,Sore injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/22/2021,1.0,PHM,"Simvastatin, Escitalopram, Levothyroxine, Tadafil",None,Constipation,"6 weeks prior had second shingles shot, nausea for two days, Did not go to doctor",None,['Injection site pain'],UNK,MODERNA,IM 1045846,,35.0,F,"Numbness on 1/2 of the face, left and drove home - resolved by the time she was home.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,UNK,,,,,,['Hypoaesthesia'],1,PFIZER\BIONTECH,IM 1045847,FL,,F,"I developed a red swelling at injection site and an itchy rash on both arms, neck, face, scalp, torso and thighs. I was prescribed oral steroid 6 day pack and also took Benedryl and Claritin. I still have the remnants of the rash and it is still a little itchy on February 22, 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/10/2021,9.0,PVT,Daily Vitamin Calcium biotin Vitamin D Losartan Pantoprazole Doxycycline Estrogen Cream,None,Hypertension GERD,"66 years old, Pneumovax 23, July 2020, Merck",Penicillin allergy Shellfish allergy,"['Injection site erythema', 'Injection site swelling', 'Rash pruritic']",1,MODERNA,IM 1045848,NJ,71.0,M,Muscle/Body Aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PVT,None,None,"Hypertension, overweight",,None,"['Myalgia', 'Pain']",UNK,PFIZER\BIONTECH, 1045849,PA,66.0,F,sudden onset of symptoms: left side of face drooping. Pain in left ear radiating along jaw line. PCP put me on course of steroids,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,02/14/2021,22.0,PVT,"Vitamin D3, Women's multi, Apple Cider Vinegar gummies, Colesevelan, Lorsartan Potassium, Bupropion HCL, Atorvastain, Omephazole",none,"Depression, diabetes, obesity",,none known,"['Computerised tomogram head normal', 'Ear pain', 'Facial paralysis', 'Pain', 'Pain in jaw']",2,MODERNA,SYR 1045850,NC,71.0,M,"All over body rash, with extreme itching, began on day 2 [Feb 9th] of receiving 2nd vaccine. It has gotten progressively worse. Tried taking Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/08/2021,0.0,OTH,"Tylenol, D3, Montelukast 10mg, Destoratadine 5mg, Levothyroxine125mg, Terbinafine 250mg",None,Thyroid [hypo],,None,"['Pruritus', 'Rash']",2,PFIZER\BIONTECH,IM 1045852,AZ,75.0,M,"UNKNOWN BRAND of VACCINE. From urgent care: 75-year-old male with essential hypertension presenting today for headache along with uncontrolled hypertension. Reading here at 187/106 and pulse rate of 113. Reports being compliant with his hypertensive medication without efficacy. Headache is new. Transferred to ED from urgent care. From ED: This patient is a 75 y.o. male p/w atraumatic headache that he woke up with this morning. Pain is located in the front, described as pressure, and currently rated 7-8/10. The pain was gradual onset and slowly progressing Associated with mild nausea. He states that he attempted to eat breakfast, but was unable to do so because of his lack of appetite and associated nausea. Worsens with nothing. Improves with rotating his head side to side. He reports a h/o similar HA with elevated blood pressure. He states that his systolic pressure was 150 this morning. The patient received his COVID vaccine yesterday which may have given him his headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/26/2021,01/27/2021,1.0,PVT,"aspirin 81 mg, fenofibrate, levothyroxine, losaran, simvistatin, triamterene-HCTZ",None,"Controlled hypertension, hyperlipidemia; hx of cholecystectomy, hernia repair",,None,"['Condition aggravated', 'Decreased appetite', 'Head discomfort', 'Headache', 'Hypertension', 'Nausea']",1,PFIZER\BIONTECH,IM 1045853,AR,46.0,F,"Moderna COVID Vaccine EUA The injection site was size of baseball. I had chills and body aches throughout the day on 2/9/21. Became feverish around 0730PM 2/9/21, temp was 102 at that point. 2/10/21 had low grade fever 99.9 and some body aches. The infection site was still warm to touch but swelling is going down.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/09/2021,1.0,PHM,"Losartan/HCL 100mg/ 25 mg ,Furosemide 40 mg, Potassium 40 meg",none,Hypertension,,"Statin medications, shrimp, shell fish","['Chills', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Pyrexia']",2,MODERNA,IM 1045854,PA,57.0,F,"Swollen, red, sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,PVT,Atorvastatin Calcium Multi vitamin Vitamin D3 Glucosamine sulfate Super complex B Garlique Probiotic Numaqula omega 3 eye vitamin,None,High cholesterol,,None known,"['Erythema', 'Pain in extremity', 'Peripheral swelling']",2,MODERNA,SYR 1045855,IL,63.0,F,"2 hours after vaccination (2/19/2021) experienced nausea and massive diarrhea for about an hour. Fever started around 5 to 6 hours later and continued for 36 hours. Area of arm receiving injection was hard, warm to the touch, and itched. After removing my shirt on Sunday the entire arm had a 4 inch red band almost the entire circumference of the upper arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,none,none,none,,none,"['Diarrhoea', 'Erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth', 'Nausea', 'Pyrexia']",UNK,MODERNA,IM 1045856,,41.0,F,"Flushing, tachycardia, lip tingling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,,,,,,"['Flushing', 'Paraesthesia oral', 'Tachycardia']",1,PFIZER\BIONTECH,IM 1045857,MA,40.0,F,"malaise, nausea, loose bowel movements a few times a day, headache- dizziness, chills, inability to focus, and fatigue - day 3-6 chills- day 7 tingling in legs and feet/hands - day 4 and continue off an off for past 2.5 weeks after vaccine headaches- continued off and off for past 2.5 weeks",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/06/2021,2.0,PVT,Levotyroxine Vitamins,none,Gilbert's syndrome hypothyroidontism,,None,"['Blood test', 'Chills', 'Diarrhoea', 'Disturbance in attention', 'Dizziness', 'Fatigue', 'Headache', 'Malaise', 'Nausea', 'Paraesthesia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,SYR 1045858,IL,70.0,F,"7 hours after injection, experienced extreme tiredness. Overnight, awoke with body aches, joint pain, and injection site pain. Early morning awoke to body aches, headache, and extreme fatigue. While not chilled, needed three layers on top and two layers on bottom and on feet. Temperature at 8AM was 97.0. Voracious appetite and ate normally and with vigor. Slept for 3.5 hours and awoke to fever of 100.3 and voracious appetite. Ate normally. Body aches and joint pain were gone. About an hour later, temperature returned to normal but headache persisted. No longer fatigued, but still tired. Headache persisted that evening and still present at this writing, 8AM Monday.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,Albuterol sulfate; Fluticasone propionate; fluticasone propionate/salmeterol; cetirizine HCl; aspirin; bifidobacterium longum; Calcium: Magnesium: Vitamin D Complex; multivitamin; potassium gluconate.,None,Asthma; Perennial Allergic Rhinitis; AFib; IBS with SIBO.,,Cardizem; codeine; flecainide acetate; levaquin; amoxicillan; tuna oil.,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Increased appetite', 'Injection site pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1045859,FL,76.0,F,"Headache, joint pain in shoulders, fingers, legs and back; stomach pain and diarrhea. Loss of appetite. All these symptoms lasted 8 hours and diarrhea continues for 48 hours. Took Tylenol and rested for first 12 hours, then continued normal daily routine. I had a severe bought of COVID 19 in March 2020, resulting in 3 weeks hospitalization. Exhaustion and pain in finger joints continue today.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/14/2021,1.0,PUB,"Bystolic 10 mg, vitamin D3",none,"high blood pressure, COPD",,Cardizem,"['Abdominal pain upper', 'Arthralgia', 'Decreased appetite', 'Diarrhoea', 'Headache', 'Pain']",2,MODERNA,IM 1045860,TX,40.0,M,"Beginning approximately one day after shot administration, I developed a red lesion at the injection site around 2 inches in diameter. Around day 5, this went away. Then, around day 8, the lesion returned, and is now about 3 inches in diameter. Both times, the lesion was red, itchy, burning, and painful to touch. The lesion appears to be consistent with reports of ""COVID Arm"" seen in some instances after receiving the Moderna shot specifically.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/18/2021,9.0,OTH,40mg Omeprazole 1 time daily 100mg Trazodone 1 time daily 5mg Escitalopram 1 time daily 150mg Bupropion 1 time daily 15mg Buspirone 1 time daily,None known,"Obesity, BMI > 30",,"Penicillin, rash and hives","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Skin lesion']",1,MODERNA,IM 1045861,IL,63.0,F,"i was fine until then last night my arm started inching and this morning i have a rash and its red, hard to move my rm. it is heaviness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,SCH,,,,,,"['Limb discomfort', 'Mobility decreased', 'Pruritus', 'Rash erythematous']",1,MODERNA,SYR 1045862,WI,36.0,M,"Pfizer-BioNTech COVID-19 Vaccine EUA I started developing itchy hives and rash on tops of my hands and around my elbows. Also on my feet and under my armpit. There are also random hives appearing on different parts of my body. These symptoms have been happening during daytime hours on 3 separate days so far, starting two days after my second dose of the Pfizer vaccine. After taking a cetirizine tablet the rash and hives subside after a couple hours. Then it starts up again in the morning upon arrival at work.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/19/2021,2.0,PHM,Levothyroxine 100 mcg tablets,,hypothyroidism,,,"['Pruritus', 'Urticaria']",UNK,PFIZER\BIONTECH, 1045863,IL,48.0,F,Large red spot at the site of the injection appeared 2 weeks after the shot.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/22/2021,14.0,PHM,Synthroid; Vitamin D; daily multi vitamin,no,Hypothyroidism,,no,['Injection site erythema'],1,MODERNA,SYR 1045864,MI,76.0,M,"Had postponed quarterly steroid shot for inflammatory arthritis and stopped Celebrex 500 mg BID three days prior to shot to maximize response to vaccine. On fourth day following vaccine, woke to terrible arthritis pain in left shoulder and across back and chest. Pain continues to present but helped some by tramadol 50 mg . Not sure if it was vaccine related or if stopping anti-inflamatory meds allowed arthritis pain to resurface. Have scheduled shoulder replacement.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/07/2021,4.0,OTH,"metoprolol ER, atorvastatin",,"osteoarthritis, hypertension, asplenetic",,"tetracycline, hydroxychloroquine",['Arthralgia'],1,MODERNA,IM 1045865,,73.0,F,"Feb. 12 (day after shot) red sore arm lasting 4 days. Feb. 18 headache, nausea lasting 1 day. Feb.19 woke up with redness near injection sight. ..very sore and itchy. Still have redness at injection sight today (Feb. 22) Treatments : ice, 1% Hydrocortisone, Benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/11/2021,02/18/2021,7.0,UNK,,,,,,"['Erythema', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Nausea', 'Pain in extremity']",1,MODERNA,IM 1045866,,84.0,F,": Spoke w/ pt. who stated she recd her 1st covid vaccine 2.5 wks ago, Pharmacy, Moderna. At that time, she noted lethargy as her only SE, and mild redness at vaccination site. Now, however, there is a ""4inch x 2 inch circle"" around her left deltoid, and it is ""blotchy inside the ring"". She denies chills, fever, arthralgias, SOB, palpitations, urticaria. When she contacted pharmacy's she was advised to call her PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/06/2021,02/10/2021,4.0,PHM,,,,,,"['Injection site erythema', 'Lethargy', 'Rash macular']",1,MODERNA,IM 1045867,,32.0,U,"About 15 hours after my second dose of the Pfizer vaccine, around 3:15AM on 2/18/21, I woke up with chills, nausea, aches in my neck, back, head, and at injection site. Took my temperature twice and it was 100.3 each time. I then proceeded to dry heave for about ten minutes. Around 8AM I spoke with Employee Health. She asked about other symptoms and I informed her that I noticed small, tender bumps near my groin when she asked about swollen lymph nodes. Shortly after this phone call I vomited and my temperature had gone to 100.6. I took Tylenol every 6 hours the rest of this day and slept. The next day, 2/19/21, upper arm where the shot was administered was sore to the point where I could not move it. I continued taking Tylenol every 6 hours although most other symptoms had subsided. By 2/20/21 I was still feeling lethargic and sore but stopped taking Tylenol to get a true temperature; fever has not returned since. As of today, 2/22/21, I would say I am at 95%. Still have a minimal amount of lethargy and swollen lymphs but other than that I am fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/18/2021,1.0,PVT,,,,,,"['Body temperature increased', 'Chills', 'Headache', 'Injection site pain', 'Lethargy', 'Lymphadenopathy', 'Nausea', 'Neck pain', 'Pain', 'Retching', 'Swelling', 'Tenderness', 'Vomiting']",UNK,PFIZER\BIONTECH, 1045868,,39.0,F,"Welts on trunk, generalized pruritus, tingling on lips. Trapsorted to ED. Contacted by allergy - declined consult.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/23/2020,12/23/2020,0.0,PVT,,,,,,"['Paraesthesia oral', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 1045869,AZ,53.0,F,good,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,UNK,"Atorvastatin 10 mg tab at bed time 01 , Trazodone 100 mg At bed time 2, gabapentin 300 mg 1 in the morning 1 at noon 2 at bed time goli apple cider vigar gummies 3 a day and tylenol as need it",,,,,['Unevaluable event'],UNK,MODERNA, 1045870,MI,58.0,F,"Fever, body aches, chills, nausea, loss of appetite",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,SCH,"Clarinex, Flonase, Sudafed",None,Allergies,,"Biaxin, Atrovent, wheat, molds","['Chills', 'Decreased appetite', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,SYR 1045871,MA,42.0,F,"Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February 5, 2021 at 2:03 PM. She received this here at facility campus vaccine clinic. She felt a strange tingling sensation immediately upon receiving the injection that extended from the injection site across her upper back but otherwise tolerated the injection well. Because of her history of food allergy she was advised to remain at the vaccination clinic for 30 minutes. During that 30-minute wait period she felt generally well however began to develop pruritus at her back in the legs. She did not mention this to the staff at the vaccine clinic and did not look at her skin. The pruritus was not too bothersome and she left the vaccine area after 30 minutes and walked down to our clinic to return to work. Her pruritus intensified very quickly upon returning to her desk and within a few minutes of after her return she went into the bathroom to look at her back and had patches of red, raised, urticarial lesions across her back. She began to feel itchy all over her body. She remained at work and did not take any medication or seek any medical help. She did not look at her legs. The pruritus intensified and when she looked at her skin of her legs approximately 1 or 2 hours later she had developed urticaria essentially head to toe. She had large confluent patches of urticaria at bilateral thighs, urticaria at her face, trunk, arms, legs. � At this point she felt otherwise well. She went home and took 10 mg of Claritin and applied a topical Benadryl cream to her skin. This was not helpful. She had severe pruritus of her eyes and eyelids. She took 50 mg of oral Benadryl which also was not particularly helpful. Sometime in the middle of the night that night she developed chills, felt feverish, and developed intense muscle and joint aches. She took an unknown dose of ibuprofen with minimal improvement in muscle and joint pain. She did have improvement in fever. Following day was Saturday, she spent the whole day in bed in extreme pain. She describes the pain at her wrists as feeling as though ""somebody was breaking my bones"" with any movement of her wrists. She had pain even laying flat in her bed and had severe pain at all of her joints with movement. She tried taking a flexeril with no improvement. She recalls a T-max of 102 sometime on Saturday or Sunday. At that time she had been taking ibuprofen around-the-clock. She also took 10 mg of Claritin approximately every 4 hours. Each night she also took 50 mg of Benadryl. She continued to experience urticarial skin rash and intense pruritus of the skin. The urticaria waxed and waned during this time. She also developed a fever blister at her lower lip. She spent most of Sunday in bed also. She was feeling a bit better by Monday however still had intense pruritus. Skin rash was much improved at most of her body however she still had mild urticaria at her face. She did not have a fever on Monday but was continuing to take ibuprofen around-the-clock. She discontinued ibuprofen yesterday and has not had fevers or chills since Sunday. At this point her urticaria has essentially resolved. She continues taking claritin 10mg BID to 3 times a day and also 50mg bendaryl at bedtime. � She did not experience any bruising related to this rash however did have excoriation from scratching particularly at her face. � Throughout the course of these days she did not have any episodes of angioedema of the lips, tongue. She denies difficulty breathing, cough, wheezing, shortness of breath, throat tightening, nausea, vomiting, diarrhea, dizziness, lightheadedness, syncope. � She has a history of oral allergy syndrome with peanut. Promethazine has caused diplopia, weakness. Simvastatin caused muscle weakness. She has never had any issues with vaccines. She has been getting a flu shot yearly with no difficulty. Her most recent vaccine was October 8, 2020, quadrivalent influenza vaccine. � No known history of allergy to polyethylene glycol. � No history of chronic urticaria. She takes NSAIDs frequently without any difficulty. She has not taken any NSAIDs prior to receiving this injection or developing this urticaria. She had however taken 10 mg of Claritin prior to receiving this injection. � She has no history of anaphylaxis. She has undergone surgery under general anesthesia on more than one occasion without issue. No history of reaction to stinging insect venom. She receives immunotherapy for inhaled environmental allergens here in our office and has done well with this. � She denies any recent medication changes or new over-the-counter medications. � She has not previously been diagnosed with COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,PVT,Loratadine,None known,"Migraines, constipation, GERD, Peanut allergy, allergic rhinitis, gastric bypass, dyslipidemia",,"Peanut: Shortness of breath Simvastatin: muscle weakness Promethazine: Diplopia, fatigue","['Arthralgia', 'Chills', 'Erythema', 'Eye pruritus', 'Eyelids pruritus', 'Injection site paraesthesia', 'Myalgia', 'Pain', 'Paraesthesia', 'Pruritus', 'Pyrexia', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 1045872,PA,51.0,F,"Redden circle are at injection site, warm to touch, minimal pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/21/2021,13.0,PVT,"Multivitamin, calcium citrate, lovasa, vitamin b, baby aspirin, cardizem, vitamin d, metformin, iron, Cozaar, Lipitor, Lantas, novolog",None,Type II diabetes Sinus tachycardia Only one kidney,,Seasonal allergies Codeine Tricor IVP dye,"['Injection site erythema', 'Injection site pain', 'Injection site warmth']",1,MODERNA,SYR 1045873,MI,31.0,F,"blurry vision (now resolved), dizzy/weak, sore arm. Side effects so bad that the patient was unable to drive home from work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,OTH,acetaminophen (TYLENOL) 325 MG tablet Benzoyl Peroxide (KP BENZOYL PEROXIDE WASH) 10 % LIQD clindamycin (CLEOCIN T) 1 % external solution doxycycline (MONODOX) 100 MG capsule fluticasone (FLONASE) 50 MCG/ACT nasal spray hydrOXYzine (ATARAX),,"Digestive Obesity (BMI 30-39.9) � Nervous Headache, migraine Polyarthralgia � Genitourinary Abnormal uterine bleeding � Other Acne vulgaris History of abnormal cervical Pap smear Pseudoseizures Hx of carpal tunnel syndrome Generalized anxiety disorder",,"Keppra [Levetiracetam]Rash Macrobid [Nitrofuran Derivatives]GI Upset SeasonalItching, Sneezing","['Asthenia', 'Dizziness', 'Impaired driving ability', 'Pain in extremity', 'Vision blurred']",2,PFIZER\BIONTECH,IM 1045874,KY,31.0,F,"The night of the second dose of my Pfizer Covid vaccine, my face began to feel hot and tight. The next day, I began with the expected flu like symptoms of the vaccine, accompanied by a red, fine bumpy rash with some swelling on my face where it had felt hot and tight the evening prior. The flu like symptoms lasted about 24 hours. The facial rash persisted and I began oral antihistamines - diphenhydramine and famotidine. The rash continued for one full week, only improving after beginning to use topical hydrocortisone on my face at the suggestion of a friend who is a nurse practitioner. After improvement in the rash I stopped hydrocortisone and antihistamines. The rash reappeared about 5 days later, and continues to randomly reappear about once a week to every 10 days. Flares only last about 24-36 hours now and will go away without medication but it does clear faster with hydrocortisone and antihistamines. The rash only flares at night, and no triggers like heat, alcohol or certain foods seem to bring it out. I have been consistently taking famotidine and cetirizine daily since the last flare of the rash, and have not experienced a flare again yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,Yaz oral contraception,None,"Precordial catch syndrome, mitral valve prolapse as a child (per cardiology this has corrected itself)",,Allergies to the adhesive in surgical drapes,"['Erythema', 'Hot flush', 'Influenza like illness', 'Muscle tightness', 'Rash', 'Swelling face']",2,PFIZER\BIONTECH,IM 1045875,WA,34.0,F,"Redness to injection site beginning the date of vacination which grew to the size of a 4"" circle. Intense pain in the left shoulder, neck, upper arm and left elbow.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/07/2021,5.0,PHM,"Celcept Vit D, B2, Fish Oil, Multi Vit, Lidocane patch, Diclofanac topical gel",None,Lupus SLE,,"Sulfa, Bactrim, Leviquin, Latex,","['Injection site erythema', 'Injection site pain', 'Neck pain']",1,MODERNA,SYR 1045876,IL,77.0,F,Patient began to feel faint and lightheaded.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/21/2021,1.0,OTH,Heart Medication,,,,Unknown,['Dizziness'],1,PFIZER\BIONTECH,IM 1045877,NC,82.0,F,The patient started running a fever of 101 within 12-24 hours of receiving her second covid vaccine and was suffering from altered mental status. She was transported via EMS where she was admitted until her d/c home on 2/20/21.,Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/16/2021,02/17/2021,1.0,PVT,"aspirin 81mg QD, losartan 50mg QD, metoprolol 50mg BID, ondansetron 4mg prn, meloxicam 7.5mg QD prn.","metastatic melanoma with lung nodules, recent H. pylori gastritis, GERD, Hypertension, CAD s/p aortic valve replacement, hypokalemia, thrombocytopenia","metastatic melanoma with lung nodules, GERD, Hypertension, CAD s/p aortic valve replacement",,codeine,"['Blood culture negative', 'Blood lactic acid', 'Blood potassium decreased', 'Blood urine present', 'Chest X-ray normal', 'Computerised tomogram head normal', 'Mental status changes', 'Pyrexia']",2,MODERNA,IM 1045878,SC,35.0,F,"Cold chills began at 100am 2/4; severe nausea and vomiting (could not hold down water) , 8/10 pain in headache, extreme fatigue began at 8am. Intensity resolved around 2pm 2/4. Head fog, variable chills and headache persisted through afternoon of 2/5.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/04/2021,1.0,WRK,Pedialyte and Tylenol taken after the vaccine,Sinus infection within last month and treated with antibiotics,Seasonal allergies - being treated with weekly allergy injections,,"All grasses, mold, peanuts, cats, dust, seasonal allergies","['Chills', 'Feeling abnormal', 'Headache', 'Nausea', 'Vomiting']",2,MODERNA,IM 1045879,,30.0,F,"Erythema at injection site, Injection site pain, Pruritis, Swelling at injection site, Urticaria > 100mm or >10cm Disorientation, Dizziness, Headache, Lightheadedness, Weakness, Myalgia Nausea, vomiting Fatigue, Headaches, Nausea and Vomiting, Rash significant, prevents daily activity",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/01/2021,02/09/2021,8.0,WRK,,,,,,"['Asthenia', 'Disorientation', 'Dizziness', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria', 'Myalgia', 'Nausea', 'Rash', 'Vomiting']",2,MODERNA, 1045880,MD,62.0,M,"Weakness after exercising 5 hours after vaccination. Chills while sleeping Saturday evening. Sore arm, head ache in early hour of Sunday. Lost sense of smell and taste while eating breakfast on Sunday morning ( 8:00 AM) Mild headache for the remaining of the day, no taste or smell during lunch (2:00 PM). Before going to bed (10:00PM) regain faint sense of smell, took 2 Tylenol. Woke up fine on Monday morning, smell and taste is back to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,OTH,Paxil,none,Digestive,,Bee sting,"['Ageusia', 'Anosmia', 'Asthenia', 'Chills', 'Headache', 'Pain in extremity']",1,MODERNA,IM 1045881,NJ,36.0,M,Having cough and itching in throat,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/12/2021,1.0,UNK,No,No,No,,No,"['Cough', 'Throat irritation']",1,MODERNA,SYR 1045882,NV,52.0,F,"Started having chills and feeling feverish within about an hour of receiving shot and was fatigued for a day. That only lasted the day. However, the side effect that is more concerning is that, about four days after the shot, I noticed that the area around the injection site, other than the bruise, was inflamed. The swelling and heat have gone down a bit, but there is still indication and a feeling on inflammation about the size of my palm around the injection site. Also, I have still been suffering from some fatigue. I usually sleep well and wake up refreshed, but since the shot, I wake up still very tired, and I have been getting enough sleep.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,PHM,"Weider?s Red Yeast Plus, Kirkland Calcium supplements plus Vitamin D, Eye Science Macular Degeneration Formula, Beverly Hills MD Skin Renewal Vitamins/Herbal supplements, occasional pharmacy brand fexofenadine",seasonal allergies,Eczema,Hepatitis vaccine when I was 21; fainted. That was all.,"Sulfa, Penicillin, Lodine,","['Fatigue', 'Feeling cold', 'Injection site inflammation', 'Injection site swelling', 'Injection site warmth', 'Pyrexia']",1,MODERNA,IM 1045883,KY,54.0,F,"Started with a headache and cough about an hour after the injection (Monday). I woke up the next morning (Tuesday) at 5 AM with a fever of 102.2. I then proceeded to run a fever the rest of that day up to 104.4 although I was taking both Tylenol and Motrin alternating. I also had severe muscle aches and pain and very tired. On the next day (Wednesday) my fever did not get above 102 and finally got down to 99.6 about 6pm that evening. The body aches, tiredness and pain continued that day. On Thursday the low grade fever resolved and the body aches, pains and tiredness started to lessen. On Friday I felt like myself with just some minimal tiredness. The cough also continued throughout the post vaccine period and finally resolved on Sunday.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,PVT,"Bisoprolol, zyrtec, Enablex, Vitamin C, Pepcid, Probiotic, Move Free, Zinc, Tumeric, Vitamin D, Magnesium, Quercetin","Bronchitis January 8, 2021 (rec'd 1st vaccine 1/3/21)","tachy arrythmias, seasonal allergies, stress incontinence",,"Penicillin, Ampicillin, Biaxin, PPD","['Cough', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",2,MODERNA,IM 1045884,MD,82.0,F,"Patient was hospitalized, presenting to the ED with confusion/encephalopathy. She was also found during her hospitalization to have hypoglycemia, CAP, UTI, and liver cirrhosis with elevated LFTs/ammonia. She was given antibiotics and lactulose to manage. Patient recovered and was later discharged",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,02/01/2021,02/12/2021,11.0,PVT,"Carbidopa-levodopa, rasagiline, tolterodine, valsartan, insulin glargine, insulin aspart",,"depression, diabetes, hypertension, hyperlipidemia, Parkinson's disease",,"Adhesive, fenofibrate, gabapentin, glimepiride, hydrochlorothiazide, iodinated contrast and iodine-containing products, mirtazapine, Montelukast, penicillins, statins, niacin, sulfa antibiotics","['Ammonia increased', 'Confusional state', 'Encephalopathy', 'Hepatic cirrhosis', 'Hypoglycaemia', 'Liver function test increased', 'Pneumonia', 'Urinary tract infection']",1,PFIZER\BIONTECH,IM 1045885,MN,46.0,F,"Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Oral benadryl liquid given (50mg) and 2 doses of Epi-pen given. Ambulance arrived and transported patient to emergency room.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/21/2021,02/21/2021,0.0,SEN,,,,,,"['Asthenia', 'Dizziness', 'Dysphagia', 'Dyspnoea', 'Flushing', 'Hyperhidrosis', 'Tachycardia', 'Throat tightness', 'Visual impairment']",1,MODERNA,IM 1045886,TX,69.0,F,"Swelling, redness, pain and itching at injection site. Benadryl tablet taken 2-22-2021 at 8:30 A.M.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/20/2021,0.0,PUB,"too many to list here, but a list was shown at time of injection but ignored by staff",none,"neuropathy on left side, fibromyalgia, arthritis, auto-immune disorder, migraines",,Too many to list here but shown at time of injection and ignored by staff,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA,IM 1045888,MA,36.0,F,"after receiving the vaccine, I have developed a skin intolerance to heat (hot water, hit items touching skin), heat causes itching and tingling and well as redness and swelling with hotter temperatures at longer durations. This has been occurring since after receiving the first vaccine, with increased severity after the second. The symptoms last from 20-2 hours after exposure and then resolve.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/22/2020,12/22/2020,0.0,WRK,none,none,none,,none,"['Condition aggravated', 'Erythema', 'Hyperaesthesia', 'Paraesthesia', 'Pruritus', 'Swelling', 'Temperature intolerance']",1,PFIZER\BIONTECH,IM 1045889,AL,80.0,F,"rash, hives and itching",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,PUB,"bp, Macrodantine, doxycycline.",no,bp,,,"['Pruritus', 'Rash', 'Urticaria']",2,MODERNA,IM 1045890,CT,,U,"Swelling and pain in left arm, evening of the shot. Enough to disturb sleep. I used benedryl lotion and took 2 Advil . Slight redness at site the next morning. Slept longer than necessary. Still have swelling 2 days after",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PHM,,,,,,"['Injection site erythema', 'Pain in extremity', 'Peripheral swelling', 'Sleep disorder']",1,MODERNA,IM 1045891,CO,24.0,F,"Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/17/2021,0.0,SEN,,,,,,"['Dysphagia', 'Throat tightness']",2,PFIZER\BIONTECH,IM 1045892,FL,74.0,F,"Cold chills,bad headache and lower back and neck ache/pain from 12:30 on the 18th till 19th then cold chill stopped back and head ache pain continues till Saturday 20th am Tylenol was taken didn't help much I continue to get slight headache as of today 22nd Monday fine now except slight head and back pain",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/18/2021,1.0,OTH,"Aspirin,cetrizine,calcium,vit.D,probiotic prescription are Alentrondate sodium,attestation and she drops playability and timolol",No,No,,No,"['Back pain', 'Chills', 'Feeling cold', 'Headache', 'Neck pain']",1,PFIZER\BIONTECH,IM 1045893,NC,36.0,F,after 20 minutes post administration my tongue started a mild twitching,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/13/2021,0.0,WRK,"gabapentin,",,n/a/,,lactose,['Tongue spasm'],UNK,PFIZER\BIONTECH,IM 1045894,MN,84.0,M,"COVID infection, death",Yes,02/07/2021,Not Reported,Yes,12.0,Not Reported,,12/31/2020,01/27/2021,27.0,PVT,,,,,,"['COVID-19', 'Death']",UNK,MODERNA, 1045895,FL,89.0,M,He was found deceased in his home by Sheriff and paramedics evening of 2/21/21.,Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,PHM,Heart meds recently changed by cardiologist . Inhalers for asthma. Other unknown,None know,"Heart arrhythmia, enlarged prostate, low blood pressure, CAD, asthma, season allergies/hay fever, spinal stenosis, with neuropathy",,Unknown,['Death'],2,MODERNA,SYR 1045896,MN,41.0,F,"Red, warm to touch, swelling, itching at injection site 1 week post administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/17/2021,7.0,PUB,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 1045897,FL,76.0,F,"When I woke on the 19th I was trying read my bible and I couldn't concentrate and I was really cold. I went to back to bed and slept most of the day. I was really cold and fatigued and didn't have an appetite. I took some Tylenol. I woke up about 3:30 AM Saturday and my back, arms and my head were all hurting and I took some Tylenol and went back to bed. I woke up about 6AM and was covered in sweat. I didn't want to do anything Saturday, I rested most of Saturday and Sunday. Today the 22nd I am back to my normal self.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,UNK,"Baclofen 10 MG twice a day, Hydrochlorothiazide 25 MG once a day, Clonazepam .5 as needed, Vitamin D3 125 MG daily, Allegra 1-2 times a day, Supplement with Calcium, Magnesium, Zinc 4 a day, Vitamin B-12 2500 MG daily",,Dystonia,,reaction to Tetracycline 20 years ago,"['Back pain', 'Decreased appetite', 'Disturbance in attention', 'Fatigue', 'Feeling cold', 'Headache', 'Hyperhidrosis', 'Pain in extremity']",1,MODERNA,SYR 1045898,RI,81.0,F,"Site: Pain at Injection Site-Mild, Systemic: loss of hearing in one ear-Medium",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/16/2021,2.0,PHM,,,,,,"['Deafness unilateral', 'Injection site pain']",1,MODERNA,IM 1045899,AZ,45.0,F,"Headache (intense) - lasted about 36-48 hours, Body aches - onset around 12 hrs later - lasted about 24-36 hours Chills - onset around 12 hrs later - lasted about 24-36 hours Fatigue - lasted about 48 hrs Pain in left armpit/breast/lymph area - about 32 hours after and persisted for another 18 hrs or so I know that this was probably just a strong immune response, but it was highly uncomfortable. I am glad to be protected from COVID!",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,WRK,Errin (prescription birth control) Zinc supplement,None,None,,Allergy to ibuprofen Allergy to pork and all pork products,"['Axillary pain', 'Breast pain', 'Chills', 'Discomfort', 'Fatigue', 'Headache', 'Pain']",2,MODERNA,SYR 1045900,OK,71.0,M,"Headache, body ache, Lymph Nodes swolen under left arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/21/2021,2.0,PVT,"Meloxicam 15mg, Tamsulosin .4mg x2, Finasteride 5mg , Testosterone Gel pump 1.62% 75 gym 20.25mg 2 pumps, Omeprazole Dr caps 40mg, Ocuvite 1 cap, Centrum Silver , Osteo Bi-flex 1-am, 1-pm, Citrical 1-am,1-pm, Iron 65mg-325 mg ferrous sulf",none,none,,Codeine,"['Headache', 'Lymphadenopathy', 'Pain']",2,PFIZER\BIONTECH,IM 1045901,,62.0,F,Tachycardia: Palpitations started at 0900 Dr at bedside immediately. Reports hx of SVT. VS @ 0904 BP 142/85 HR 146-169 pulse ox on RA PT husband called at 0908 came inside with wife at 09:11 with service dog. Service dog presence made pt calm immediately Palpiatations resolved at 0912 no complaints VS @ 0913 130/85 HR 120 100@ Pt insisted she feels 100% better at 0930 on decided to leave facility with husband and service dog at this time,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,WRK,,,,,,"['Condition aggravated', 'Palpitations', 'Tachycardia']",1,PFIZER\BIONTECH,IM 1045902,OH,71.0,M,"71 year old with HTN, HLD, CAD s/p CABG, ischemic cardiomyopathy, AAA s/p EVAR, and COPD presented for elective left heart cath without intervention. Allergy consulted due to anaphylactic reaction several hours after procedure. Patient was stable on RA at time of presentation and vitals were normal and stable during the procedure from 8-9 AM. Procedure log reviewed. He received fentanyl, versed, heparin, omnipaque, and xylocaine during the procedure. No immediate reactions noted and no change in vitals during procedure. He tolerated procedure well and was transferred to the cardiac recovery room on RA with normal vitals. � At 1217, patient received percocet and at 1 PM, desaturations noted on flowsheets (84% from RA). Noted pain level of 10/10. HR increased to 130s-150s and BP did drop as low as 99/87. Per notes, he developed shortness of breath, rash, and itching with this. Given albuterol, racemic epinephrine, diphenhydramine IV, famotidine IV, and solumedrol. After developing nausea, he was given IM epinephrine at 2:10 pm. Then, symptoms rapidly improved and he was transferred to CVICU. He was shortly weaned from BIPAP (briefly hypercarbic) to nasal cannula and eventually 1-2L NC.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/15/2021,02/19/2021,4.0,PVT,"aspirin 81 mg daily, atorvastatin 80 mg once daily, symbicort 160-4.5 1 pugg bid, carvedilol 9.375 mg BID, diphenhydramine 25 mg q6h prn, enalapril 2.5 mg twice daily, eplerenone 25 mg once daily, nitroglycerin 0.6 mg sublingual tablets eve",,"Coronary artery disease s/p CABG, COPD, AAA s/p EVAR, HTN, HLD, former smoker 40 pack year history",,"torsemide - itching and rash. ekg leads - redness, delayed itching 12+ hours.","['Anaphylactic reaction', 'Base excess increased', 'Bilevel positive airway pressure', 'Blood bicarbonate normal', 'Blood methaemoglobin', 'Blood pH decreased', 'Blood pressure decreased', 'Carbon dioxide increased', 'Carboxyhaemoglobin normal', 'Catheterisation cardiac', 'Dyspnoea', 'Haematocrit normal', 'Haemoglobin normal', 'Heart rate increased', 'Intensive care', 'Mean cell haemoglobin concentration', 'Mean cell haemoglobin normal', 'Mean platelet volume normal', 'Nausea', 'PCO2 increased', 'Pain', 'Platelet count normal', 'Pruritus', 'Rash', 'Red blood cell count normal', 'Red cell distribution width increased', 'White blood cell count decreased']",UNK,PFIZER\BIONTECH,IM 1045903,NJ,58.0,F,"The first symptoms was pain in the injection site. Then felt pain traveling down to my left arm and fingers. I was told I was only to stay 15 minutes after the shot. On my way home from the vaccination about 30 minutes after the shot, I felt sick. I had a rapid heart rate and itch red hives on my left chest and left palm of my hand. My husband stopped along the road and gave me benadryl. I still had hives the next day. On the third day I had vaginal spotting and I am in menopause and I had extremely bad pain in my left hip, left thigh and left buttocks for 2 weeks. I could not sit or stand up to get relief. I cried with pain and thought I would never recover. I visited a urgent care and he suggested I see a neurologist for the pain. I was tested for covid at that time and was negative. I went to an allergist to see if I am allergic to the PEG in the vaccine. I am not allergic to the compound. She believes my body had a very strong immune response to the vaccine which caused all the symptoms described above. All symptoms were strictly limited to just the left side of my body. I do not know what to do about taking the second dose because I am afraid it will be worse.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,SCH,Anastrazole - 1mg - every day Rosuvastatin - 10 mg everyday Vitamin D - 3000,No,Breast cancer survivor - no health concerns,,No,"['Allergy test', 'Arthralgia', 'Blood test', 'Heart rate increased', 'Injection site pain', 'Metrorrhagia', 'Musculoskeletal pain', 'Pain', 'Pain in extremity', 'Rash pruritic', 'SARS-CoV-2 test negative', 'Urticaria']",1,PFIZER\BIONTECH,SYR 1045904,NV,41.0,M,"Initial symptoms began about 8 hours after injection. Body aches, chills/sweats, headache, fatigue. Lasted approximately 24 hours. No treatment sought.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,MIL,"Fexofenadine (Allegra 180mg, 1/day)",None.,"None No other place to enter this info: -Infected with Covid-19, symptoms started 04/11/20, tested positive 04/12/20. Similar symptoms lasted 6 days to include fever. Tylenol to control fever/headache, no further medical treatment sought. -Tested positive for antibodies 01/13/2021.",,NK,"['Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Pain']",1,MODERNA,SYR 1045905,MA,55.0,F,"Swelling, tenderness over the injection site. Lymphadenopathy right axilla, tenderness started the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,PHM,"Diltiazem, Wellbutrin, B12, Coconut oil, vitamin D, Tumeric.",None,"Junctional tachycardia, depression",,"PCN, Sulfa","['Injection site pain', 'Injection site swelling', 'Lymph node pain', 'Lymphadenopathy']",2,MODERNA,IM 1045906,MI,40.0,F,"A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went stiff, where my thumbs couldn?t move away from my inner palms and my other fingers would not bend. I also had difficulty speaking, as if my tongue was numb or hard to move. �This lasted about an hour (15 hrs post-vaccine).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/19/2021,3.0,OTH,"ADDERALL XR 20 MG 24 hr capsule amphetamine-dextroamphetamine (ADDERALL XR) 5 MG 24 hr capsule cholecalciferol (CHOLECALCIFEROL, VITAMIN D3,) 10 MCG/ML LIQD Cholecalciferol (VITAMIN D PO) diphenhydrAMINE (BENADRYL ALLERGY) 25 MG capsule Fex",none,none,,"Adhesive- Hives Eggs- Nausea Only, Dermatitis Peppers Nightshade vegetables, strawberries, cantaloupe, oatmeal, corn, avocados, eggs, and all nuts- Nausea/Vomiting/Diarrhea LatexRash Metals - gold, nickel, potassium dichromium- Rash","['Asthenia', 'Dizziness', 'Heart rate increased', 'Hypoaesthesia', 'Musculoskeletal stiffness', 'Paraesthesia', 'Paraesthesia oral']",2,PFIZER\BIONTECH,IM 1045907,VA,75.0,F,"Up until yesterday my left arm just felt tender. During the day yesterday ( 8 days after vaccine) my arm started itching, and skin hurt. Today it's very hot, very itchy, skin hurts and there's a large red area 2-3 inches around injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PHM,"Crestor 5 mg, Extra Strength Estroven, Vit C, Calcium w/ Vit D3, Glucosamine w/ chondroitin",none,Type 2 Diabetes - diet controlled High Cholesterol - controlled with Crestor,,Tetracycline Sulphur,"['Injection site erythema', 'Pain of skin', 'Pruritus', 'Skin warm', 'Tenderness']",1,MODERNA,SYR 1045908,IA,40.0,F,"Severe body aches, fever of 103, headache, diarrhea and gassy stomach. Symptoms began approximately 24 hours after injection and have persisted since. They have decreased in severity.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,PUB,None,None,Seasonal allergies and specific food allergies.,,"Food allergies to: strawberries, watermelon, hazelnut and beef. Pollen allergies to: all trees, grasses and animals","['Diarrhoea', 'Flatulence', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,SYR 1045909,,62.0,M,"Dizziness upon standing, hypotension. Did not take his daily hydrocortisone or lisinopril, did not eat prior to coming. Transported to ED where he was given his usual medications and monitored, discharged.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,"Supposed to take daily hydrocortisone and lisinopril - did not that day, nor did he eat prior to coming for vaccine",,"HIV, Adrenal insufficiency",,,"['Dizziness postural', 'Hypotension']",1,PFIZER\BIONTECH,IM 1045910,IL,77.0,F,Patient was given vaccine in left deltoid at 90 degree angle.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/16/2021,02/16/2021,0.0,OTH,,,,,Radiology Contrast Dye,['Unevaluable event'],1,PFIZER\BIONTECH,IM 1045911,IN,73.0,F,"Chills, fever 101.4, headache, joint pain, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PUB,"Allopurinol, aspirin, calcium + D, metoprolol, multivitamin, omeprazole, triamterene, vitamin B-12 , vitamin C, vitamin D 3, zinc, and fish oil.",,Asthma (mild),,"Cefzil, betadine and Brazil nuts","['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Pyrexia']",2,MODERNA,SYR 1045912,MI,91.0,F,"91 YEAR OLD FEMALE FELT TINGLING AND NUMBNESS IN BOTH HER LEGS AFTER RECEIVING THE VACCINE. ON SITE EMS RESPONDED. BP 180/90. SHE STATED THAT SHE DID NOT TAKE HER MEDICATIONS THIS MORNING. IT WAS RECOMMENDED FOR HER TO GO TO HOSPITAL FOR FURTHER EVAL AND SHE REFUSED. SHE WILL GO TO E.R IF SYMPTOMS PERSIST BUT FOR NOW, SHE WILL GO HOME HAVE BREAKFAST AND TAKE HER MEDICATIONS.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PUB,HBP MEDICATIONS,,"HIGH BLOOD PRESSURE, NEUROPATHY",,"DILAUDID, STRAWBERRIES, PENICILLIN, SHELL FISH","['Hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 1045913,MI,91.0,F,"91 YEAR OLD FEMALE FELT TINGLING AND NUMBNESS IN BOTH HER LEGS AFTER RECEIVING THE VACCINE. ON SITE EMS RESPONDED. BP 180/90. SHE STATED THAT SHE DID NOT TAKE HER MEDICATIONS THIS MORNING. IT WAS RECOMMENDED FOR HER TO GO TO HOSPITAL FOR FURTHER EVAL AND SHE REFUSED. SHE WILL GO TO E.R IF SYMPTOMS PERSIST BUT FOR NOW, SHE WILL GO HOME HAVE BREAKFAST AND TAKE HER MEDICATIONS.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PUB,HBP MEDICATIONS,,"HIGH BLOOD PRESSURE, NEUROPATHY",,"DILAUDID, STRAWBERRIES, PENICILLIN, SHELL FISH","['Blood pressure increased', 'Hypoaesthesia', 'Paraesthesia']",1,MODERNA,IM 1045914,IL,50.0,F,"Moderna COVID-19 Vaccine EUA On Saturday, Feb. 20, 2021 I woke around 4:00 a.m. cold and shivering, my neck and head hurt. I took my temperature orally (the only thermometer I had at home), it was 101.9. I took Tylenol, it helped a little. I was lethargic throughout the day. My head and neck hurt all day and into Sunday, even with Tylenol. I did not sleep well Saturday to Sunday, started coughing, but only when laying down, (maybe allergy related?) so I sat up and slept in a chair. I woke up Sunday without a fever, no Tylenol, but still had achy neck and a slight headache. I did continue to take Tylenol because my neck and head still hurt. But I was able to move around, a little, if I overdid it, I had to sit.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PVT,Zyrtec and One A Day Women's 50+ Vitamin,,Environmental and animal allergies,,No,"['Body temperature increased', 'Chills', 'Cough', 'Feeling cold', 'Headache', 'Neck pain']",2,MODERNA,IM 1045915,VT,73.0,F,"7 days after the vaccination she developed pain, redness and itching around the vaccination site and extending down",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,PVT,"calcium carb-ergocalciferol (vit D2) 600 mg calcium-200 unit tablet 1 tab orally once daily Qty: - Refills: 0 Date Written: 02/17/20 Problem: - Stop Date: - Diagnosis Code: - cholecalciferol (vitamin D3) 25 mcg (1,000 unit) capsule 25 mcg o",NONE,"Paroxysmal atrial fibrillation, rheumatoid arthritis, hypothyroidism, hypercholesterolemia, Raynauds",,NKDA,"['Injection site erythema', 'Injection site pruritus', 'Vaccination site pain']",UNK,MODERNA,IM 1045917,IL,37.0,F,"10 minutes after vaccine patient said she was feeling lightheaded and wanted to lay down. Laid her down and put feet up and she was also very cold. Laid for 15 minutes, when trying to sit up with 2 assists. She was up for 30 seconds and was lightheaded again. Laid her down and she passed out. Smelling salts had to be used to wake her up. Vital signs were not un-normal. Continued to lay for 30 minutes. She was alert and orientated.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PUB,,,depression,,,"['Dizziness', 'Dizziness postural', 'Feeling cold', 'Loss of consciousness']",1,MODERNA,IM 1045918,NC,74.0,M,1) Itching and stinging sensation - began 2/20/21 morning - ongoing but diminishing in frequency and discomfort. 2) Fever - 101.8 began about 2 pm 2/20/21 and continued until about 10 pm. For item 20 below: Fever - yes Itching/stinging - no,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/20/2021,1.0,OTH,"Allopurinol (300mg), Aspirin (81mg), Atorvastatin (20mg), Olmesartan (30mg), Fish Oil (1000mg), Indomethacin (50mg), Multivitamin, Glucosamine, Vitamin C (1g). Vitamin D3 (5000 IU)",None,,,"Meloxicam, Telmisartan, Sulfa Antibodies","['Pain', 'Pruritus', 'Pyrexia']",2,MODERNA,SYR 1045919,FL,74.0,F,"First Vaccine, no side effects except sore arm for one day and a lot of bruising at injection site which left in 8 days. Vaccine 2 awakened at 2:00 AM in extraordinary pain in my whole body,, dry heaved for 4 hours, sweats and chills, temp only 99 (I usually run 97) Felt sick to stomach rest of day. Never felt this sick. By evening it left as quickly as it came. Was tired for several days but nothing else. On Feb 16th awakened with an very sharp pain in the injection site when I moved my arm up to stretch. This has gotten worse every day. When I move my arm in a certain direction it feels like it is ripping inside. It is not bruised and not painful to the touch. It is inside and in the same location as the injection. Heat and ice make no difference. It seems to be getting more painful and feel it more often. It is painful enough that I let out a yelp when I forget and lift my arm a certain way. As of yesterday I feel it all day, not the sharp pain but more a inside burning, not enough to stop me, but I know it os there.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/16/2021,6.0,PVT,"3.5 mgs prednisone, 4.5 Mgs LDN (low dose naltrexone) Vitamin B complex , Mineral complex supplement and Tumeric supplement.",GCA diagnosed surgically March 2019,GCA,,,"['Abdominal discomfort', 'Body temperature increased', 'Burning sensation', 'Chills', 'Fatigue', 'Hyperhidrosis', 'Injection site pain', 'Malaise', 'Pain', 'Retching', 'Screaming', 'Skin laceration']",2,MODERNA,IM 1045920,MI,68.0,F,"Vaccine given with immediate pain. ""Hurts so bad"" ""I I kind of screamed when she gave it and I wasn't expecting it since nobody else seemed to have that reaction"" . Patient came into office to have arm observed, Injection site appears to have been mid deltoid. She c/o pain in muscle area and above to just below shoulder . Above injection site appeared swollen, no redness.-Observed by nurse.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/02/2021,0.0,PUB,"Effexor, Prilosec","Asthma, Prolong QT","Asthma, Prolong QT",,"PCN, azithromycin, Bees","['Injection site pain', 'Injection site swelling']",1,MODERNA,IM 1045922,FL,54.0,F,"Got my first case of shingles, diagnosed yesterday (02/21/2021). I started treatment (Methylprednisolone and Valacyclovir) yesterday. Since I just received my 2nd COVID-19 vaccine a little over one week after the start of shingles, I thought it may be related and wanted you to check it out. Thanks!",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/18/2021,9.0,PVT,"Rosuvastatin, Pantoprazole, Levothyroxine, Multi-Vit, Vit B-Complex, Calcium, Enteric ASA, Joint/Flex Vit.",None,"Hypothyroidism, Acid Reflux, Hypercholesterolemia","COVID-19 Moderna (approx.01/21/2021) 1st dose: Minor reactions: Swelling and pain on vaccine arm, low-grade fever, nausea & vomi",None,['Herpes zoster'],2,MODERNA,IM 1045923,KY,37.0,F,"I was suppose to receive my 2nd Covid vaccine dose on Thursday 2/11 at the Drive Thru site; but my appointment got cx?d due to our weather. So it got rescheduled to Thursday 2/18 at 12p. My 1st dose was Moderna. I gave the lady my card and a Moderna sticker is clearly on it and readable. She came back to my vehicle and gave my 2nd injection; apparently she gave me Pfizer (I didn?t know that until she handed my card back to me). She handed my card back; I looked down at it and saw it said Pfizer. I said, ?What just happened? I got Moderna the 1st time why does my 2nd one say Pfizer?? She didn?t have anything to say. She then left immediately to go get someone else to talk to me. This person said I wasn?t the 1st person this has happened to. It still has the same mRNA molecules in both vaccines. She also said I shouldn?t need another dose of any vaccine. I should be okay even though I got the different vaccine. I was also told by her that when the sites run out of Moderna or Pfizer; then they are giving (employees and the public) the opposite one that they have on hand. (I don?t know how true this is but this is what I was told). After this happened I contacted my Director and my Manager and informed them of what happened. They both said I did nothing wrong Director contacted our Employee Health office. Then the Employee Health Nurse called me to check on me and get some information. Nurse called me again on Friday to see how I was and to take more information to fill out an incident report. Then she was going to talk to the Head Pharmacist again and get back to me about what he said. I haven?t heard back from her yet. I?m still upset because that incident should never have happened (and it?s bad that it happened to an employee). Our employees need to slow down. They need to make sure their name badge is visible (the lady giving mine- I never saw her badge). Then they need to verify what vaccine they have in their hand with the pt/person again before they inject it to avoid another situation from occurring like mine). What I?m more upset about is: there is no research as far as what having 1 dose of Moderna and 1 dose of Pfizer is going to do to my body?? Am I protected at all? Am I more protected? Will I have bad side effects later? We don?t know. That?s the scary part. I just don?t want this to happen to another employee or anyone else. So far the only thing I had happen to me since the injection is a painful sore left arm. I have no idea what effects I may have later...??.... from having Moderna in my system; then Pfizer.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,OTH,Armour Thyroid 60mg tablet Take 1 tablet by mouth daily Famciclovir 500mg tablet Take 1 tablet by mouth daily Levocetirizine 5mg tablet Take 1 tablet by mouth daily. Lo Loestrin Fe 1 mg-10mcg Tabs Take 1 table,None,None,,Sulfa Bandaid Adhesive,"['Interchange of vaccine products', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 1045924,MI,80.0,F,"Blotchy rash on arms and legs started on morning of February 15. Went to doctor on Wednesday, February 17. He gave rx for Hydroxyzine. Symptom is still existing but not as bad. Also, had chills the next day after vaccination on Friday, February 12 but only lasted one day and is gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/15/2021,4.0,PUB,Lisinopril 20 mg,none,high blood pressure,,none,"['Chills', 'Rash', 'Rash macular']",2,PFIZER\BIONTECH,SYR 1045926,RI,79.0,M,"Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: slurred speech, confusion, possible seizure, minimal right side of body function-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Seizure-Severe",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,02/16/2021,02/16/2021,0.0,PHM,,,,,,"['Confusional state', 'Dizziness', 'Dysarthria', 'Hemiparesis', 'Hypoaesthesia', 'Injection site pain', 'Seizure']",1,MODERNA,IM 1045927,NE,32.0,F,"positive at home pregnancy test 2/4/21 (same date as vaccine given). However, light bleeding/spotting started that night/next day but thought still normal. Heavier bleeding started 2/6/21 (Saturday) and continued through the weekend. Made appointment at hospital lab for Monday 2/8 to check HcG levels in blood. See below for details, but Dr. suggested repeat blood work on 2/10 as Hcg levels showed positive pregnancy, but very low. 2/10 Hcg levels slightly lower, which confirmed early miscarriage occurring.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/06/2021,2.0,PVT,"Omemprazole, Setraline, Claritin-D, Prenatal Vitamin",none,none,,"dust, pet dander, seasonal","['Abdominal pain', 'Abortion spontaneous', 'Back pain', 'Exposure during pregnancy', 'Human chorionic gonadotropin', 'Vaginal haemorrhage']",2,MODERNA,SYR 1045928,NY,57.0,F,Rapid heart rate Burning through body Cold sweat Felt low blood pressure,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,UNK,Estrodial Bystolic,,High blood pressure,,All seafood Iodine Sulfa,"['Cold sweat', 'Heart rate increased', 'Hypotension', 'Skin burning sensation']",1,PFIZER\BIONTECH,SYR 1045929,NJ,67.0,F,"After 5-6 days, itching at site. Itching is becoming more intense. Using Triamcinolone Acetonide to relieve symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/14/2021,02/19/2021,5.0,PHM,"advil calcium with magnesium zinc picolinate VITAMINS D3, K, C turmeric",none,none,,CT contrast dye zuccini,['Injection site pruritus'],1,MODERNA,SYR 1045930,CO,66.0,F,"Rash (raised, warm, itchy) below injection site noticed about a week after vaccine. Today (2/22/21) 2 raised itchy bumps in palm of right hand.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,PHM,"Slow release ferrous sulfate, Vit C, Vit D3 (as cholecalciferol), Calcium (as 80% calcium citrate, 20% calcium carbonate), Magnesium (as 50% magnesium glycerinate, 50% magnesium citrate",none,osteoporosis,,Sulfa,"['Injection site reaction', 'Injection site warmth', 'Rash', 'Rash papular', 'Rash pruritic']",1,MODERNA,IM 1045931,TX,66.0,F,"Day 9-13 arm red, slightly swollen at injection site. Now has faded. Topical Benadryl applied. Aspirin and oral Benadryl taken.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/13/2021,9.0,PUB,"Multi Vitamin,B12",none,None,,"Sulfa, Cephalexin, wasp venom","['Injection site erythema', 'Injection site swelling']",UNK,MODERNA, 1045933,,59.0,M,"Nausea, diarrhea, EXTREME VERTIGO, chills and body pains in my joints,. Saw a PA and was told to drink plenty of fluids and get rest.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/16/2021,5.0,UNK,ibuprofen,none,"Chronic pain, back, hip, and knee.",,none,"['Arthralgia', 'Chills', 'Diarrhoea', 'Nausea', 'Vertigo']",UNK,MODERNA,SYR 1045934,OH,36.0,M,"The best guess is contact dermatitis on the upper-back. Not as severe as shingles, but warm, stinging, and itchy red bumps. Started roughly five days following injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/20/2021,5.0,PHM,Tecfidera - 240mg 2x/day Aspirin - 275 mg daily Daily multivitamin 5000 IU D3 daily Daily fish oill,,Multiple Sclerosis,,Hayfever,"['Dermatitis contact', 'Pain', 'Rash erythematous', 'Rash pruritic', 'Skin warm']",1,MODERNA,IM 1045935,GA,56.0,F,"Hives to arms, legs and torso. No change since onset. No medication taken.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/21/2021,2.0,PUB,over the counter stool softener,none,none,,"sulfa, NSAIDS, PCN",['Urticaria'],UNK,MODERNA, 1045936,VA,51.0,F,"1 hour after COVID vax dose # 2 administration, individual reported onset of upper body itching, neck swelling and skin was blotchy red. Neck swelling more on left than right. Short term feeling of altered breathing -- > ""real or panic"" per individual -- > self resolved. Left deltoid area Injection site redness, hot to touch and swollen developed as well. ""general un-well"" feeling all day 2/21/21. She reports sxs improvement today. She was given Claritin (as can not function after taking Benadryl) by Medical Personnel (Detention Ctr employee) -- > itching sensation lessened.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,PUB,"Lisinopril; Furosemide, Calcium, One A Day Multiple Vitamin; Biotin - not all medications taken that date",none,hypertension; thyroid nodule,"left area injection site redness, swelling and ""hot to touch""",sulfa; codeine; tylenol; penicillin; benadryl; blue cheese,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Malaise', 'Pruritus', 'Rash macular', 'Respiration abnormal', 'Swelling']",2,MODERNA,IM 1045937,OH,72.0,F,"1:05PM SLIGHT SOB, FACE FLUSHED, FEELS NERVOUS. NO DYSPNEA NO TROUBLE SWALLOWING. 1:06PM BENADRYL 50MG GIVEN P.O. HR 112, O2 SAT 98% 1:35PM SYMPTOMS IMPROVED. HUSBAND TO DRIVE PT HOME. HR 97. NO ACUTE DISTRESS NOTED. (2-10-21 9AM TC - STATES SHE FEELS 'ALOT BETTER'. DOES HAVE SOME CHILLS/ACHES./4PM TC - FELT 'FLUSHED' STATES BP124/64, HR 94 TO 101. STATES SHE CALLED HER CARDIOLOGIST AND TOOK HER METOPROLOL.)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,PUB,,HAD COVID DISEASE 12-11-2020,A FIB,,"EPINEPHRINE, CIPRO, METHELPREDNISONE","['Chills', 'Dyspnoea', 'Flushing', 'Heart rate increased', 'Nervousness', 'Pain']",1,MODERNA,IM 1045938,MD,60.0,F,"Fatigue, muscle ache, nausea which has continued to present day",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/12/2021,4.0,PUB,HZT Clonidine Amitriptyline Flonase,IBS w/Diarrhea,HBP post-stroke vestibular seasonal allergies and asthma multivitamin,,"Dairy, penicillin","['Fatigue', 'Myalgia', 'Nausea']",UNK,MODERNA,SYR 1045939,WI,56.0,F,"Nosebleeds with elevated blood pressure began at 7:00 am on February 14, took 45 minutes to control at home, 2nd nosebleed February 15 at 5:00 am took 45 minutes to stop at home, saw PCP at 10:00 am, referred to ENT, February 16 nosebleed at 5:00 am, went to ER at 8:00 am, applied Afrin and TXA, February 17 Midnight nosebleed back in ER at 1:00 AM, silver nitrate used to cauterize 2 spots on right side of nose, February 17 10:00 PM nosebleed stopped after 45 minutes starting bleeding again at 1:00 AM went to ER recauterized one spot. February 18 appointment with ENT cauterized several areas with silver nitrate, February 21 10PM nosebleed again went to ER per ENT instructions, stopped bleeding, they put in afrin, got home Februray 22 1:00 AM bleeding started again applied afrin and pressure, stopped 30 minutes later. Appt with PCP February 22 at 10:00 am",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/14/2021,5.0,PUB,"Metformin, carvedelol, lorsartan, ventolin, amlodipine, trospium ER pantaprazole, Vit D3, Vit C",Maxillary Right Central incisor root resorption with bleeding,"Diabetes 2, High BP, urinary incontinence, asthma, reflux",,"Penicillin, Sulfa Drugs, Latex","['Activated partial thromboplastin time', 'Blood test', 'Cautery to nose', 'Condition aggravated', 'Electrocardiogram', 'Epistaxis', 'Full blood count', 'Hypertension', 'Metabolic function test', 'Troponin I']",2,PFIZER\BIONTECH,IM 1045940,,53.0,F,"Patient reported, feeling ""like I have to cough,"" dizziness, lightheadedness, headache. Patient evaluated by EMS staff. BP 167/95, P 116, O2 100%. Upon further questioning, patient reports h/o POTS syndrome, autonomic dysfunction, dual chamber pacemaker and low BPs on occasion. Re-evaluated by EMS done 15 minutes later, BP 170/95, P 100, O2 100% patient refused to go to ER. Patient monitored in clinic for an additional 30 minutes. Stated symptoms had resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/18/2021,0.0,PVT,,,,,,"['Dizziness', 'Feeling abnormal', 'Headache']",1,PFIZER\BIONTECH,IM 1045941,VA,52.0,F,States 30-40 minutes post injection face and lips began to swell. Took Benadryl x3 and symptoms resolved by next morning,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,PVT,,None,,,Vicodin,"['Lip swelling', 'Swelling face']",1,PFIZER\BIONTECH,IM 1045942,,36.0,M,"Nausea and dizziness immediately, rash on forearm 24 hours after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Dizziness', 'Immediate post-injection reaction', 'Nausea', 'Rash']",1,PFIZER\BIONTECH,IM 1045943,OH,85.0,F,"Client complains of normal vaccine side effects on 2/18 and 2/19 (chills, muscle aches, nausea, vomiting). Client reports extreme arm pain, redness, and swelling of arm. Redness and swelling has now extended down past elbow of right arm. Advised client to seek medical treatment by primary care physician.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/20/2021,2.0,PUB,"Synthroid, multivitamin",,Chronic Lymphocytic Leukemia,,Penicillin,"['Chills', 'Erythema', 'Myalgia', 'Nausea', 'Pain in extremity', 'Peripheral swelling', 'Vomiting']",2,MODERNA,IM 1045944,NC,73.0,M,"I HAD MY FIRST VACCINE ON 6 FEB 2021 AT FACILITY ABOUT 6:00PM. THAT WAS ON A SATURDAY. ON THE FOLLOWING TUESDAY, I HAD A PAIN IN MY LEFT ARM FROM THE INJECTION SITE DOWN THRU MY ELBOW JOINT AND CONTINUING ON TO MY LEFT WRIST. I HAVE HAD THE PAIN EVER SINCE. I DID NOT REALIZE THAT TIREDNESS, MUSCLE PAIN, JOINT PAIN AND FEELING UNWELL ALONG WITH DIZZINESS AND WEAKNESS WERE SYMPTOMS OF A POSSIBLE REACTION TO THE VACCINE. SOME OF THESE SYMPTOMS COULD BE FROM A PREVIOUS STROKE.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/08/2021,2.0,OTH,"torsemide 20 MG tablet Commonly known as: DEMADEX Learn more Take 3 tablets (60 mg total) by mouth daily. keep appointment as scheduled. No refills remaining Prescription Details PrescribedFebruary 10, 2021 Approved by, MD Refill Details Qu","Please review your health issues and verify that the list is up to date. Call 911 if you have an emergency. Hyperlipidemia with target LDL less than 130 Added 6/10/2010 Learn more GOUT Added 3/27/2008 Learn more BPH (benign prostatic hyperplasia) Added 3/27/2008 Learn more Peripheral neuropathy (HCC) Added 8/2/2011 Learn more Morbid obesity (HCC) Added 5/9/2014 Learn more Prediabetes Added 11/5/2014 Learn more H/O laparoscopic adjustable gastric banding & hiatal hernia repair 1/6/15 Added 1/21/2015 Learn more Diastolic congestive heart failure (HCC) Added 4/15/2015 Learn more Chronic anticoagulation Added 4/21/2015 Learn more Gastric ulcer with hemorrhage 4/19/15 Added 4/21/2015 Learn more PAF (paroxysmal atrial fibrillation) (HCC) Added 4/28/2015 Learn more Periodic limb movement sleep disorder Added 3/18/2016 Learn more Basal cell carcinoma of skin Added 3/27/2016 Learn more Recurrent pulmonary emboli (HCC) Added 3/12/2017 Learn more GERD (gastroesophageal reflux disease) Added 3/12/2017 Learn more Encounter for monitoring flecainide therapy Added 1/26/2018 Learn more Dysphagia, post-stroke Learn more Neurologic gait disorder Learn more OSA (obstructive sleep apnea) Learn more Embolic cerebral infarction (HCC) Added 3/21/2018 Learn more Wallenberg syndrome Added 3/30/2018 Learn more Benign essential HTN Learn more Vocal cord dysfunction Added 8/22/2018 Learn more Vocal fold paralysis, left Added 11/27/2018 Learn more Lumbosacral spondylosis without myelopathy Added 9/17/2019 Learn more B12 deficiency Added 2/13/2020 Learn more Plantar fasciitis of left foot Added 8/13/2020 Learn more Acute foot pain, left Added 8/13/2020 Learn more Type II diabetes mellitus with manifestations (HCC) Added 8/13/2020 Learn more Pain of left calf Added 11/6/2020 Learn more This information is from another organization. Dysphonia Added 11/27/2018 Learn more This information is from another organization. Dysphagia Added 11/27/2018 Learn more",CONGESTIVE HEART FAILURE OBESITYY pULMONARY EMBOLISMS RECURRING,A REACTION TO PENICILIAN SHOT AS A TEEN.,"Propoxyphene N-Acetaminophen Nausea Only Learn more Morphine Nausea And Vomiting, Other (See Comments) Learn more Codeine Nausea Only Learn more Penicillins Other (See Comments) Learn more","['Arthralgia', 'Asthenia', 'Dizziness', 'Fatigue', 'Injection site pain', 'Malaise', 'Myalgia', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 1045945,MO,76.0,F,at first i was fine and the next morning i noticed my whole bottom lip was swollen. Lasted about 2 days after taking Benadryl.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PVT,"B pollin, Rial Jelly, enapril, levothyroxine, bupropion, topiramate, B 12, D3, Celebrex, baby aspirin, melatonin 10 mg, centrum silver",,Osteoarthritis really bad,,,['Lip swelling'],1,PFIZER\BIONTECH,SYR 1045946,MD,55.0,F,"Starting about 12 hours after shot: Fever of 99.5 for about 48 hours, painfully achy joints for 24 hours, intermittent headache , breathlessness and fatigue continuing. I walk 4-6 miles, briskly 5 or 6 days out of 7 (briskly meaning 15-18 minutes per mile). This morning could not walk 200 yards without being so out of breath I had to bend over my knees to catch it, as if I had sprinted a 400meter race. And just feel tired.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,OTH,Adderall XR 30 mg Wellbutrin 75 mg,None,None,,None,"['Arthralgia', 'Dyspnoea', 'Fatigue', 'Gait disturbance', 'Headache', 'Pyrexia']",2,MODERNA,SYR 1045947,KS,67.0,M,"HYPERGLYCEMIA INTO THE 500S WITH CONFUSION, WENT TO THE ED FOR EVALUATION AND RECEIVED INSULIN TO HELP BRING IT DOWN SAFELY.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,UNK,,,TYPE 1 DM ON INSULIN PUMP,,,"['Blood glucose increased', 'Confusional state', 'Continuous glucose monitoring', 'Hyperglycaemia', 'Increased insulin requirement', 'Metabolic function test']",1,MODERNA, 1045948,PA,60.0,F,"Left eye pain developed in afternoon along with left injection site pain (expected.) Later on I had a bad headache, fever, chills, all expected. When all other symptoms were resolved 2 days later eye pain persisted. Still present today even though milder .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,PVT,None,None,None,Menactra. I think it was 2004 when my hospital geve vaccine to all staff. Severe visual disturbance. Resolved in a few hours.,None,"['Chills', 'Eye pain', 'Headache', 'Injection site pain', 'Pyrexia']",2,MODERNA,SYR 1045949,MN,61.0,F,Infection in arm at site of injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/30/2020,2.0,WRK,"Certinlen, lisinopril, levovoxine",,,,Throxycincine,['Injection site infection'],1,MODERNA,IM 1045950,UT,36.0,F,"I have a large lump (axillary area) in the armpit of my left arm which is the injection arm. I noticed it roughly two days after the 2nd injection. It was non painful at first, but now it is tender. It is roughly the size of an egg/golf ball. I also have tenderness on my chest above my right breast but on the pectoralis muscle. Nothing in the right armpit. I also had aggressive itching at the injection site and a hard area and red welt.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/20/2021,2.0,UNK,"Soliqua, Metformin ER, Jardiance, Levothyroxine, Prozac, Lamictal, Krill Oil, Vitamin B12, Biotin, Crestor, Tizanidine",None,"Diabetes, Graves Disease/Hashimotos/Hypothyroidism, PCOS, anxiety",Previously reported to you with first Covid vaccine,NKDA,"['Axillary mass', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site urticaria', 'Lymph node pain', 'Musculoskeletal chest pain', 'Myalgia']",2,PFIZER\BIONTECH,IM 1045952,MI,53.0,M,"AFTER RECEIVING THE VACCINE HE COMPLAINED OF STABBING CHEST PAIN. ON SITE EMS RESPONDED. HE WAS TAKEN TO THE AMBULANCE FOR AN EKG. IT WAS RECOMMENDED TO GO TO THE HOSPITAL BY AMBULANCE, BUT HE REFUSED AND LEFT AGAINST MEDICAL ADVISE. I WASN'T ABLE TO GET ANY VITALS FROM EMS.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PUB,"IMDUR, PLAVIX. ASPIRIN,TOPROL, LIPITOR",,HE HAS A STINT IN HIS HEART AS WELL,,,['Chest pain'],2,MODERNA,IM 1045953,VA,47.0,M,Mild/moderate Pain at injection sight - lasted for 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,PVT,Crestor 5mg QD,N/a,Hyperglycemia,,N/a,['Injection site pain'],1,PFIZER\BIONTECH,IM 1045954,,70.0,F,"""During monitoring period post Pfizer COVID-19 vaccine, patient experienced slight throat tightness and tingling in tongue reported to EMS. Given benadryl 12.5mg by mouth. Patient symptoms improved and went home.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/18/2021,0.0,PVT,,,,,,"['Paraesthesia oral', 'Throat tightness']",1,PFIZER\BIONTECH,IM 1045955,OH,50.0,F,"Body aches around 8PM, by 2AM chills fever of 100.5. The next day around 4pm laid down to take a nap woke with a huge lump under my left armpit. Very painful and achy. I have taken ADVIL to help with the swelling and pain. 5 days after shot the lump has gone down but still there. I have also had a lot of chest pain and discomfort with a lot of heart burn.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,WRK,Synthroid,,,,Ketek Levaquin doxycycline augmentin codeine,"['Axillary mass', 'Axillary pain', 'Chest discomfort', 'Chest pain', 'Chills', 'Dyspepsia', 'Pain', 'Pruritus', 'Pyrexia']",UNK,MODERNA,SYR 1045956,AZ,47.0,F,Headache Muscle aches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,UNK,none,none,none,,none,"['Headache', 'Myalgia']",2,PFIZER\BIONTECH,UN 1045957,MD,76.0,F,Patient was hospitalized after a motor vehicle accident,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/04/2021,02/12/2021,8.0,PVT,"Magnesium oxide, azelastine nasal spray, atenolol, famotidine, MVI, olmesartan, pravastatin, albuterol, aspirin, dorzolamide, fish oil",,"asthma, hypertension, melanoma of the skin, macular degeneration, peptic ulcer disease",,"Adhesive (rash), amlodipine (edema), clonidine (anxiety/fatigue), diltiazem (weakness), hydrochlorothiazide (hyponatremia), spironolactone (hyperkalemia), phenobarb-hyoscy-atropine-scop (rash)",['Road traffic accident'],1,MODERNA,IM 1045958,AL,74.0,F,"pain in neck , shoulders, muscles, and arms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/05/2021,3.0,PUB,"Proleah shot, protonix. celexa, lipitor, vit d, asa, calcium,",allergies,"osteoarthritis, stomach issues",,"Penicillin, cefdnir","['Arthralgia', 'Myalgia', 'Neck pain', 'Pain in extremity']",1,MODERNA,IM 1045959,KS,60.0,F,"Headache, chills, joint pain, severe fatigue, insomnia, some minor chest pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,OTH,None,UTI,Gerds,,None,"['Arthralgia', 'Chest pain', 'Chills', 'Fatigue', 'Headache', 'Insomnia']",2,MODERNA,SYR 1045960,TX,28.0,M,Face and eye swelled up. Also got very red. Next day low grade fever and extremely tired.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,SCH,Vyvanse.,None.,None.,,M.M.R Shot.,"['Erythema', 'Eye swelling', 'Fatigue', 'Pyrexia', 'Swelling face']",1,PFIZER\BIONTECH,IM 1045961,TN,71.0,F,"large, red rash and roughened skin on injection site on right arm, itchy, sore, lymph node discomfort beginning 14 days after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/22/2021,15.0,PUB,"Zocor, Nexium, Celebrex, Enbrel, Otezla, Pimecromulis, Metrogel, Ketoconazale, Prolia, D3, Calcium, Benadryl, Xiidra, Gabapentin","Psoriasis, Osteoarthritis, Psoriatic Arthritis, Osteoporosis, Hayfever, Rosacea, Eczema, GERD, Dry Eye Disease, Bursitis","Psoriasis, Psoriatic Arthritis, Osteoporosis, Acid Reflux, Peripheral Nerve Pain, Allergies, B12 deficiency,",shingles vaccine booster caused flu like symptoms lasting 3 days,"Penicillin, Erythromycin, many antibiotics","['Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Lymph node pain', 'Rash erythematous']",1,MODERNA,SYR 1045962,NY,65.0,F,"Pt states she is not feeling normal after getting her second dose of the vaccine. Pt does not have any rashes, hives, swelling, difficulty breathing. Pt states she has a history of anxiety and believes she is having a panic attack. Pt's vitals are stable. Pt sat and talked with EMS for 10 minutes. Pt states she is feeling better and would like to leave. Pt did not require transport to hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,"Clonazepam, Pantoprazole, Duloxetine, Levothyroxine, Metoprolol, Metformin, Rosuvastatin.",None.,"Anxiety, Gerd, High BP, Heart failure, Diabetes type 2.",,"Sulfa drugs, Augmentin, Lisinopril, Fentynol, Trazadone, Docycline.","['Feeling abnormal', 'Panic attack']",UNK,PFIZER\BIONTECH, 1045963,,59.0,F,"""During monitoring period, pt experienced throat itching and slight difficulty swallowing. VS: 145/70 given Benadryl 25mg by mouth @1400 by onsite provider. Patient was transferred to: home after additional monitoring and relief of symptoms, pt was given ER precautions",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/18/2021,0.0,PVT,,,,,,"['Dysphagia', 'Throat irritation']",2,PFIZER\BIONTECH,IM 1045965,,54.0,F,"The day after receiving the second Moderna vaccine, recipient experiences severe side effects including: arm rash, fever 102.4, joint pain (described as ""every"" joint in her body), vomiting. Symptoms lessened the next day. Third and forth days after vaccine, recipient just feels very tired. She did not experience significant side effects after her first vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Arthralgia', 'Fatigue', 'Pyrexia', 'Rash', 'Vomiting']",2,MODERNA,IM 1045966,,45.0,F,"1.5 hour post-vaccine throat swelling. Seen at anther hospital, tryptase drawn >2 hours after vaccine - results unavailable. Has not confirmed anything else after that.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,PVT,,,,,,"['Pharyngeal swelling', 'Tryptase']",1,PFIZER\BIONTECH,IM 1045967,MN,36.0,F,"Red rash around injection site around 10 days after vaccination (approx. 1 1/2 inches in diameter). No pain, itching, or swelling, and not bothersome.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/22/2021,10.0,WRK,,,,,"Medication allergies to clorohexidine, bactrim (sulfa drugs)- skin rash","['Injection site rash', 'Rash erythematous']",1,MODERNA,IM 1045968,IL,65.0,F,"I had injection site discomfort, about 4-6 hours after vaccination. I had generalized aching over all my body (joint/muscle pain) that started about 10 PM the night. I woke up Saturday morning with a bad headache, felt like I was pass out, I had chills. Saturday afternoon I noticed under right armpit the lymph nodes were swollen. The pain radiates throughout my chest and shoulder but most severe under the armpit. As of today 22nd I feel tired and I am still experiencing the swollen lymph nodes under my right arm pit. All the other symptoms have went away. The lymph node feels warm to touch, there is also a small area of redness around the injection site. I am still having post COVID-19 symptoms as well which include nasal issues, weakness and brain fog. I have had all these symptoms since November.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,UNK,"Metoprolol 25 MG twice a day, Crestor 5 MG daily, Estradiol 2 MG daily, Calcium plus Vitamin D, Vitamin B complex, Coq10 100 MG daily, Potassium 99 MG daily, Baby Aspirin 81 MG daily, Sudafed 30 MG daily, Mucinex 600 MG daily, Atrovent nas",,"Had COVID-19 in November and still having lingering side effects from it, Hypertension, Hyperlipemia",,"Penicillin, Imitrex, Verapamil, Nubain,","['Arthralgia', 'Asthenia', 'Axillary pain', 'Chest pain', 'Chills', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Headache', 'Injection site discomfort', 'Injection site erythema', 'Lymphadenopathy', 'Pain']",1,PFIZER\BIONTECH,IM 1045969,WV,47.0,F,"Swelling, warm, redness at injection site and 2 inches below which increased in size within 24 hours. Contacted physician and was prescribed Keflex for 10 days. Took all 10 days to completely clear up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,02/03/2021,8.0,PUB,"multi-vitamin, vit C,D, zinc",none,none,,none,"['Blood test normal', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 1045970,AL,77.0,F,Moderate rash on neck and shoulders,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,PVT,"Carvedilol, Diltiazem, Duloxetine, Lipitor, Losartan, Gabapentin, Trazadone, Azelastine, Areds-2",none,"Hypertension, High Cholesterol, Neuropathy",,none,['Rash'],2,PFIZER\BIONTECH,SYR 1045971,NH,52.0,F,"02/20 Approx. 4:30pm: very sharp but steady pain in liver that subsided in about 5 minutes. 02/20 Approx. 5:30pm: cramp type pain in spleen area that subsided in approx. 15 minutes. 02/20 Approx. 6:00pm: arm pain & swelling at injection site that slowly increased over time. 02/21: Arm pain increased - very painful, swelling, limited ability to move arm without pain. 02/22: At the time of this submission, the arm pain & swelling is not as bad - it's minor now.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,OTH,"Levothyroxin. Metoprolol (S). Tradjenta. Low Dose Bayer Aspirin. Crestor. Tramadol. Mylanta. Tums. 50,000 IU VitaminD2. 1000 MCG Injection B12. Probiotic Drink. Vitamin C Lozenge.",Common Cold,Diabetes Type 2. NASH & Cirrhosis From Diabetes. Hypotension. Hypothyroidism. Hashimoto?s Disease. Atherosclerosis-Abdominal Aorta. Supraventricular Tachycardia. GERD. IBS. Osteoarthritis.,,Percocet. Dilaudid. Doxycycline. Clindamycin. Proton Pump Inhibitors. Erythromycin. Augmentin. Amoxicillin. Macrobid. Budesonide. Sick W/Anesthesia,"['Abdominal pain', 'Hepatic pain', 'Hypokinesia', 'Injection site swelling', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 1045972,,78.0,F,patient passed away within 60 days of receiving a COVID vaccine,Yes,02/16/2021,Not Reported,Not Reported,,Not Reported,,02/06/2021,02/16/2021,10.0,OTH,,,,,,['Death'],1,PFIZER\BIONTECH, 1045973,NH,61.0,M,"19 hours after the injection there was fever, rigors, sweats, headache, nausea, myalgias. This lasted for approximately 30 hours then resolved. Tylenol 1000 mg q 6H and",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,OTH,"Metoprolol succinate 25 mg, rosuvastatin 20 mg, clopidogrel 75 mg, aspirin 162 mg, pantoprazole 40 mg, Januvia 100 mg, Jardiance 25 mg, glimepiride 8mg, pioglitazone 45 mg daily, valtrex 500 mg daily, buproprion xl 300 mg daily, coenzyme q",,"Chronic lymphocytic leukemia with hypogammaglobulonemia, CAD, type 2 DM, dyslipidemia",,"PCN, Sulfa, tincture of benzoin, shellfish","['Chills', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Nausea', 'Pyrexia']",UNK,MODERNA,IM 1045974,NY,24.0,F,"I experienced a full-body tingling/vibrating feeling. This includes my face/head. I also experienced vomiting and diarrhea, and extreme anxiety.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/17/2021,4.0,UNK,"Advere, birth control, olmeprazole, Flonase, amoxicillin",None,IIH or pseudotumor cerebri.,,None,"['Anxiety', 'Blood count normal', 'Blood electrolytes normal', 'Diarrhoea', 'Electrocardiogram normal', 'Paraesthesia', 'SARS-CoV-2 test negative', 'Vomiting']",2,PFIZER\BIONTECH,IM 1045975,AZ,53.0,M,"Sore Arm, Fever, Body aches, Headache. Lasted 24hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,SCH,None,None,"Diabetes, high blood pressure.",,None,"['Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",2,MODERNA,SYR 1045976,MI,82.0,F,"Patient has general malaise unknown cause . Onsite EMS was called vitals BP 168/78 99% O2 room air HR 80 Patient Treated, Transported by the EMS to the hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/08/2021,0.0,PUB,Aspirin,,,,,['Malaise'],2,PFIZER\BIONTECH,IM 1045977,ND,89.0,M,"Migrating rash with blisters, swelling of lips and tongue. Treated with prednisone 20mg x 5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/19/2021,3.0,PUB,,,,,NKA,"['Lip swelling', 'Rash vesicular', 'Swollen tongue']",2,PFIZER\BIONTECH, 1045978,VA,71.0,M,"red, discoloration at vaccinations ite.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/10/2021,9.0,PUB,"Plavix, nitroglygerin, lisinopril, Prilosec, atorvastatin, fenofibrate, Lasix, baby asprin, chlorothalidone",,"cardiac disease, hypertension","Typhus Shot in 1969, resulted in fever, fatigue x 1 day.",nkda,"['Injection site erythema', 'Vaccination site discolouration']",1,MODERNA,IM 1045979,NC,71.0,F,large red splotches and soreness on arm surrounding injection site. did not occur until almost two weeks after injection. Very low soreness and no fever. Was taken aback because was not made aware of a delayed reaction to first short.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/02/2021,02/16/2021,14.0,PUB,none,none,none,over 60 years ago to penicillin,none,"['Injection site pain', 'Injection site rash', 'Rash macular']",1,MODERNA, 1045980,MN,69.0,F,"I had the first vaccine on January 21, 2021. I developed a rash on February 16, 2021 that started with just a few bumps under my armpits and gradually went down both sides of my torso to my groin. It appeared to get much worse after the second vaccine injection. They are tiny red bumps.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,02/16/2021,26.0,PVT,"Carvedilol, Vitamin C, Vitamin D, Fish Oil, Magnesium",None,Leukemia,,None,"['Rash', 'Rash erythematous']",2,MODERNA,SYR 1045981,AZ,69.0,F,During sleep time kept waking up and feeling like I was going to vomit. Headache.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,OTH,"candasartan, pantoprazole,zinc, alendtonate , d3, B12, melatonin",none,COPD,,codein drugs,"['Headache', 'Nausea', 'Sleep disorder']",2,PFIZER\BIONTECH,SYR 1045982,OH,76.0,F,"CLIENT STATES 9:15AM ON 2-5-21 SHE WAS PASSENGER IN CAR AND HUSBAND NOTICED THAT SHE HAD STOPPED TALKING AND WAS JUST STARRING X 2 MIN, THEN BECAME RESPONSIVE AND TALKATIVE AGAIN. SHE WAS 'NOT QUITE HERSELF FOR ABOUT 3 DAYS'. MRI, MRA, CT OF BRAIN & U.S. OF CAROTIDS DONE. DX WITH RT TEMPORAL/PARIETAL CVA. NOW ON PLAVIX & ASA 81MG. HAS APPT WITH NEUROLOGIST 2-17-21. REMAINS 'NOT QUITE HERSELF AND OFF BALANCE'.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/26/2021,02/05/2021,10.0,PUB,"LODOPIN, POTASSIUM",NONE,HTN,,NONE,"['Abnormal behaviour', 'Angiogram abnormal', 'Angiogram cerebral', 'Aphasia', 'Balance disorder', 'Cerebrovascular accident', 'Computerised tomogram head', 'Computerised tomogram head abnormal', 'Feeling abnormal', 'Magnetic resonance imaging abnormal', 'Magnetic resonance imaging brain', 'Staring', 'Ultrasound Doppler']",1,PFIZER\BIONTECH,IM 1045983,MA,46.0,F,Itchy red rash left upper arm a few inches distally to vaccine site. Lasted 1 week. Never spread. Resolved on own. No treatment needed,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/14/2021,3.0,WRK,"Effexor, fish oil, multivitamin",None,Anxiety,,Penicillin,"['Injection site pruritus', 'Injection site rash', 'Rash erythematous']",2,MODERNA,IM 1045984,NY,36.0,F,"fever, chills, shaking, extreme fatigue for 20 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/26/2021,1.0,PVT,levothyroxine nuva-ring,,hashimoto's thyroiditis,I have had three adverse reactions to annual influenza vaccinations,,"['Chills', 'Fatigue', 'Pyrexia', 'Tremor']",2,MODERNA,IM 1045985,IN,59.0,F,"Became dizzy a Prox. 45 minutes after vaccine,started running a fever that night,hot/ cold chills,felt like I had p,eerily as well,then the ne t day chestfelttight, started taking myprednisone and I nhalers as needed, friday afternoon, aching. All over, and then noticed that nightmy fingers were swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,OTH,"Dilantin,vimpat, armourthyroid, statin, ubrelvy, hydralazine, vitamin d, B complex, MVI, FARXIGA,GLIPIZIDE",None,"Epilepsy, High b/p, DM 2, Migraines, hypothroidism",,Macrodantin,"['Chest discomfort', 'Chills', 'Dizziness', 'Oedema peripheral', 'Pain', 'Pyrexia']",1,MODERNA,IM 1045986,TX,57.0,M,"Mild fever onset at 4am on 2/21, mild fatigue throughout the day. Not debilitating.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/21/2021,9.0,OTH,"Losartan, Latanaprost, Skyrizi",None,"Psoriasis, high blood pressure",,none known,"['Fatigue', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 1045996,FL,17.0,U,"17 year old received their first dose of the Moderna vaccine; Aches; A spontaneous report was received from a pharmacist concerning a 17-year-old patient who received their first dose of Moderna's COVID-19 vaccine (mRNA-1273)/ product administered to patient of inappropriate age and developed aches/myalgia. The patient's medical history was not provided. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (Batch number: 011L20A) between 11 Jan 2021 and 21 Jan 2021 (date not specified) intramuscularly for prophylaxis of COVID-19 infection. Treatment information was not provided. The patient was scheduled to receive the second dose in Feb 2021. Action taken with mRNA-1273 in response to the events was not provided. The event, 17-year-old received their first dose of the Moderna vaccine, was considered resolved on the same day of vaccine administration (date not specified). The outcome of the event, aches, was not reported.; Reporter's Comments: This case report concerns a 17-year-old female patient who was administered mRNA-1273 vaccine Lot# 011L20A (inappropriate age at vaccine administration) and experienced aches. The event of aches is temporarily associated with the product use and a causal association cannot be excluded. The event of inappropriate age at vaccine administration is assessed as not applicable.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-011594:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Myalgia', 'Product administered to patient of inappropriate age']",1,MODERNA,OT 1045997,TX,53.0,M,"Headache, low grade fever, joint pain in his and shoulders, dry mouth, injection site soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,PUB,"Ozempic, Jardiance, Multivitamin, Tamsulosin, CBD Oi, Levothyroxine, Omega 3 Oil, Atorvastatin",None,"Obesity, Diabetes, Hypothyroidism","Similar symptoms from first COVID 19 vaccine shot, but not as severe",NSAIDs,"['Arthralgia', 'Dry mouth', 'Headache', 'Injection site pain', 'Pyrexia']",2,MODERNA,IM 1046000,MA,26.0,F,"Started off as a hard, itchy patch on 2/20/21. Woke up 2/22/21 to it being three sizes of the initial reaction that was reported. Lethargy, muscle ache besides my usual rheumatoligcal issues, diarrhea, and lowgrade fever have been the reoccurring symptoms. Tried icing, did not make a difference",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,PHM,"montelukast, xyzal, spironolactone, birth control, duloxetine",Sinus infection at the start of the month,"Anxiety, depression, rheumatoid arthritis, obesity",,"Amoxicillin, nightshade vegetables","['Diarrhoea', 'Induration', 'Lethargy', 'Myalgia', 'Pruritus', 'Pyrexia']",1,MODERNA,IM 1046001,CT,53.0,F,"Body aches, chills, headache, joint pain, fatigue. Red spot on left upper arm below the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,WRK,Multivitamin,Diagnosed with on COVID 12/27/20.,None.,,none,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site erythema', 'Pain']",UNK,MODERNA, 1046002,NC,67.0,F,"Last week 2/17/2021 she felt under her arm on the left hand side like her arm was aching, the achiness went across her back, then she felt it in her right arm. Her arm felt warm, and realized it was the area where she got the vaccine. She put some lotion on it, and just kept watching it and did not go away. The hand started feeling funny, different feeling to it. The redness was trying to travel underneath the arm and around it. She took an allergy pill for it, which helped the itching at first, but now it's localized more to the area of the vaccine. She does have an appointment today with her doctor. She also took some Advil but going to wait to see what the doctor tells her to do.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/17/2021,11.0,OTH,None.,None.,"Non-alcoholic fatty liver, fibromyalgia.",,None.,"['Back pain', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 1046003,MA,74.0,F,"Red itchy rash approximately 3"" x 3"" around site of injection appeared 7 days after vaccine. Arm is also swollen at site of rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,PVT,"alendronate, Vitamin D, Vitamin B, calcium/magnesium/zinc",,osteoporosis,,Keflex (cephalexin),"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling']",1,MODERNA,SYR 1046004,MD,79.0,F,"First day arm itchy on side, but not at inoculation site. Itched off and on several days. Itching increased around 02/19/21 and a sore appeared (possibly from scratching) next day. Intermittent itching persisted. 02/21/21 noticed large red rash on top and side of left arm, well demarked between rash area and non-rash area. Rash 02/22/21 is fainter but still there. Itching remains intermittent. Rash area is slightly sore when pressed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/09/2021,1.0,PUB,Simvastatin 10 mg Levothyroxin 25 mcg Lisinopril 2.5 mg Esomeprazole Magnesium 20 mg Yuvafem 10 mcg PreserVision AREDS 2 formula TheraCran One Qunol UltraCoQ10 100 mg Vitamin D3 25 mcg,none,Diabetes mellitus Type II high blood pressure high cholesterol hypothyroidism,,sulfa drugs gentamycin ophthalmic ointment English ivy,"['Injection site pain', 'Injection site reaction', 'Pruritus', 'Rash erythematous', 'Skin ulcer']",1,MODERNA,IM 1046005,ME,36.0,F,"No symptoms at the end of 15 minute observation. 45 minutes later she developed hives on her torso front & back. She was back at work at the Civic Center and she had a medical provider at their COVID vaccine clinic check on her, They initiated treatment (100mg Benadryl) and further observation for 35 minutes and was sent home. She developed hives and swelling of tongue around 6:30 pm and got a ride to the Emergency Department for further care. Received Epinephrine x1 and Benadryl. was discharged from the ER at 0430ish. No symptoms since discharge.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,OTH,"Beta blocker daily, none other",none,none,,"Morphine, flowers","['Blood test', 'Swollen tongue', 'Urticaria']",1,MODERNA,IM 1046006,MA,60.0,M,"3 days after the first injection of the Covid on the left arm the patient developed numbness on the left side of the body. 21 days later, he received a second injection on the right arm and 3 days later developed right-sided body weakness. I saw the patient for the first time on February 17, 2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/10/2021,3.0,PVT,losartan,,hypetension,,NKDA,"['Hemiparesis', 'Magnetic resonance imaging spinal abnormal', 'Magnetic resonance imaging thoracic abnormal', 'Myelitis transverse']",UNK,PFIZER\BIONTECH,IM 1046007,FL,73.0,F,"Had a first dose on 1/23/2021 with no adverse reaction other than some pain near injection shot. The second dose was on 2/20/2021. I experienced a fever of (101.7) and weakness later in the day. The next day on 2/21/2021 in addition to feeling weak with a slight fever of 99.5 I broke out with a bad rash all of my body. I went to the emergency room at 9:30 p.m. and was there for two hours. They gave me an IV which included Pepcid and a dose of Benadryl. The ER doctor prescribed Prednisone 20 MG for five days, Famotidine 20 MG for five days and an Epi pen just in case I needed it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,OTH,"Over the counter Tylenol, and Bendryl tablets (2), and Cortisone Cream for rash after developing it.",Graves disease which I take Synthroid for.,Graves disease,"Moderna, shot one had pain near injection site",Cannot tolerate SOME shellfish. Get upset stomach.,"['Asthenia', 'Injection site pain', 'Metabolic function test', 'Pyrexia', 'Rash']",2,MODERNA,SYR 1046008,IL,38.0,F,"burning in arm, and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,WRK,"Vitamin A, Vitamin E, Centrum",none,none,,none,"['Headache', 'Skin burning sensation']",1,PFIZER\BIONTECH,IM 1046009,IL,45.0,F,"It started with feeling like a sinus infection settling in to my frontal sinuses at 8th hour. Then a feeling of lethargy settled in at 10th hour. Body aches and exhaustion at 12th hour. All of those symptoms continued on till approx 38th hour. When suddenly no body aches, exhaustion or sinus pressure was present.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,OTH,ibuprofen,none,none,,none,"['Fatigue', 'Lethargy', 'Pain']",2,MODERNA,IM 1046010,IN,74.0,F,"Lip swelling, low heart rate, dizziness. Took patient to the ER for evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,,10/17/1946,02/22/2021,27157.0,PVT,Unknown,Unknown,HX of reactions,,Unknown,"['Dizziness', 'Heart rate decreased', 'Lip swelling']",2,PFIZER\BIONTECH,IM 1046011,IL,89.0,M,Patient admitted to the hospital testing COVID positive and with a GI bleed (has a hx. of chronic duodenal ulcers and was on an anticoagulant),Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/07/2021,02/16/2021,9.0,UNK,,,,,,"['COVID-19', 'Gastrointestinal haemorrhage', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1046012,TN,89.0,F,"One week post vaccination, on 2/15, patient began to have soreness in arm, extending from elbow to shoulder. On 2/17, the pain became more severe. On 2/18, the soreness seemed to be improving but not completely resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/15/2021,7.0,PUB,Unknown,Unknown,Unknown,,Unknown,"['Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 1046013,UT,53.0,F,"DOSE # 2 Felt fine for over 15 hours, then felt immediate exhaustion. Chills and cold for 5 hours Aching all over. Joints hurts, Then Fever of 100 for a few hours Dizziness All resolved within 24 hours except dizziness. This last 2 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/12/2021,1.0,UNK,Vitamin D Regular Vitamin Vitamin C Omega 3,None,Exercise Induced Asthma,,None,"['Arthralgia', 'Chills', 'Dizziness', 'Fatigue', 'Feeling cold', 'Pain', 'Pyrexia']",2,MODERNA,IM 1046015,FL,69.0,F,"LEFT ARM VERY SORE WITH A BUMP FORMING ON THE UNDERSIDE OF ARM. AT THE INJECTION SITE THERE IS BRUISING AND HURST TO LAY ON LEFT ARM. CLIENT WENT TO PCP AND THE BUMP HAD TO BE LANCED X 2 WITH ANTIBIOTICS PRESCRIBED. ALSO, CLIENT STATED THAT HER ARM ""HURT, LIKE SHE HIT SOMETHING"" IMMEDIATELY WHEN THE NURSE ADMINISTERED INJECTION.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/02/2021,02/04/2021,2.0,PUB,ULTRAM 50 MG; TYLENOL 500 MG PRN; OTC PHILLIPS COLON HEALTH,NO,"IBS, ARTHRITIS",,PCN,"['Immediate post-injection reaction', 'Incisional drainage', 'Injection site bruising', 'Injection site pain', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 1046016,PR,86.0,M,"Swelling at vaccination site, skin red and hot",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/18/2021,9.0,PUB,Levoehyroxing 65mg Amlodinine Besylate 2.5 mg Aspirin 81 mg Symbicort 160-4.5,,COPD,,Tramomina,"['Erythema', 'Injection site cellulitis', 'Skin warm', 'Vaccination site swelling']",1,MODERNA,IM 1046017,IL,40.0,F,"Body aches, fever, headache, loss appetite and sleepless",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,02/20/2021,28.0,OTH,Levothyroxine,None,None,"Swollen arm, 40 y.o., 1/23/21, moderna",Tylenol,"['Decreased appetite', 'Headache', 'Insomnia', 'Pain', 'Pyrexia']",2,MODERNA,SYR 1046018,FL,29.0,F,"High fever for 24 hours that couldn't be controlled with OTC meds, chills/sweats, severe headache and dizziness, shaking, muscle cramps (all lasted about 24 hours straight through. Muscle and joint pain and weakness continued through 48 hours. Left arm, under arm and shoulder were very tender and mobility restricted through day 3.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,OTH,None,None,Asthma,"cold symptoms, headache after yellow fever vaccine in 2010)",None,"['Arthralgia', 'Asthenia', 'Chills', 'Dizziness', 'Headache', 'Hyperhidrosis', 'Injected limb mobility decreased', 'Injection site pain', 'Muscle spasms', 'Myalgia', 'Pyrexia', 'Tenderness', 'Tremor']",2,PFIZER\BIONTECH,SYR 1046020,IA,36.0,F,"3 days after vaccine (2/5/21): mild fever (normally 96.5 - consistent temp over the course of several months on two different thermometers, was 98), worsening of sore throat, runny nose, fatigue, chills/feverish feeling. Negative strep that day, negative covid test the following Monday. Resolved within 48 hours. 8 days after vaccine (2/10/21): developed rash at injection site, tenderness, swelling, and itching - right arm had very minimal, minor rash at the same time. Pain was more significant than the two days post injection and improved within 48 hours (still have itchy, dry, raised skin but minimal redness as of 2/22/21). 16 days after vaccine (2/18/21): lymph node in front of neck area by collarbone swollen. No pain but minor discomfort. It feels like a 2 inch squishy mass with a hard node in it. I've never had swelling here before. If my other lymph nodes are swollen as well I cannot tell. I had the flu shot at the end of December, 2020. Not sure if that was close enough to matter, no symptoms after that one.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/12/2021,10.0,OTH,Levothyroxine,"Sore throat reported, negative strep and covid tests.",Hypothyroidism,,Sulfa,"['Chills', 'Condition aggravated', 'Discomfort', 'Dry skin', 'Erythema', 'Fatigue', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Lymphadenopathy', 'Oropharyngeal pain', 'Pruritus', 'Pyrexia', 'Rash', 'Rhinorrhoea', 'SARS-CoV-2 test negative', 'Skin swelling', 'Streptococcus test negative']",1,MODERNA,SYR 1046021,MA,67.0,F,"Redness and itching at injection site. (Have photo if requested) ""Covid Arm"" or delayed cutaneous hypersensitivity.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/18/2021,7.0,PUB,Levothyroxine Atorvastatin Multi-vitamin AREDS2 Aspirin,None,High Cholesterol Hypo Thyroid Macular Degeneration,,Bactrim Penicillin Decongestants,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 1046022,GA,70.0,M,"Developed what I have determined as delayed cutaneous hypersensitivity. Hardness at injection site, slight redness, and severe itching on the left arm from shoulder to elbow.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/19/2021,2.0,OTH,losartan 25 MG atorvastatin 20 MG baby aspirin multi vitamin vitamin D3 Vitamin C Zinc Garlique CO Q10,,mild hypertension,pneumonia vacine,none,"['Dermatitis allergic', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Type IV hypersensitivity reaction']",2,MODERNA,IM 1046023,FL,52.0,F,"Left arm (arm that had shot) became itchy, red, mildly sore and inflamed one week after the shot. It seems slightly better today but is still red and itchy and a little raised.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/13/2021,02/20/2021,7.0,UNK,"nexium, zyrtec, vitamin D, multivitamin",,asthma,,"many antibiotics, carrots, shellfish, seafood, latex","['Erythema', 'Inflammation', 'Pain in extremity', 'Peripheral swelling', 'Pruritus']",1,MODERNA, 1046024,MD,38.0,F,"Raised bumps that itch on ankle, elbow, wrist, leg, arm and foot started on 21 Feb 2021 and is still present. Showering and benadryl 25 mgs did not resolve the issue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/20/2021,9.0,PVT,Birth control Prenatal Vitamins,None,None,,None,"['Rash', 'Rash papular', 'Rash pruritic']",1,MODERNA,IM 1046025,PA,77.0,F,"extreme confusion, vomiting, temp 101.6 F",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/31/2021,1.0,PVT,Tylenol/ Elavil/ Norvasc/ Eliquis/buspar/ tums/vit d3/ voltaren gel/ hydrochlorithiazide/ Mobic/ metformin/ multi vitamin and provastatin,,diabetic type II hypertension osteoporosis hyperlipidemia,,cipro floxacin/ sulfa/ lipitor,"['Body temperature increased', 'Confusional state', 'Vomiting']",1,MODERNA,IM 1046026,FL,42.0,F,"Developed acute pericarditis on 2/14/2021. Completely healthy 42 yr old with no recent illnesses other then the vaccine. Developed myalgia, severe headache, and slightly elevated blood pressures 24 hours post second vaccine. Then 4 weeks later acute pericarditis.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/11/2021,02/14/2021,34.0,PVT,None,None,None,,Coconut,"['Blood pressure increased', 'Headache', 'Hypertension', 'Myalgia', 'Pericarditis']",2,PFIZER\BIONTECH,IM 1046027,MA,77.0,M,"2-3 weeks after COVID vaccination, patient presented to hospital with anemia and thrombocytopenia and intracranial hemorrhage. L axillary mass (same side as Pfizer vaccine admin site) found on exam. Bone marrow biopsy demonstrated Burkitt's Lymphoma. He is undergoing treatment at hospital",Not Reported,,Not Reported,Yes,,Not Reported,U,02/03/2021,02/11/2021,8.0,UNK,Atorvastatin,Healthy,"HTN, GERD",,No known allergies,"['Anaemia', 'Axillary mass', 'Biopsy bone marrow abnormal', ""Burkitt's lymphoma"", 'Haemorrhage intracranial', 'Injection site reaction', 'Thrombocytopenia']",UNK,PFIZER\BIONTECH, 1046028,,26.0,F,Patient had received vaccine on 2/20 and started to have extreme fatigue the night of the 20th. patient states on Sunday 2/21 she was very short of breath and had some chest heaviness. Was taken to the ER where she was diagnosed with a vaccine reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,UNK,,,,,,"['Chest discomfort', 'Dyspnoea', 'Fatigue', 'Vaccination complication']",UNK,PFIZER\BIONTECH, 1046029,CA,33.0,F,Gr�vida 2. EDD:7/15/21. Numbness/tingling to face for about 45 min.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,PVT,Prenatal vitamins,None,None,,None,"['Exposure during pregnancy', 'Hypoaesthesia', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 1046030,MN,50.0,F,Fever for 3 Days-as high as 103F Severe Aches Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/06/2021,0.0,OTH,Vitamin D and Turmeric Supplements,None,Obesity,,None,"['Headache', 'Pain', 'Pyrexia']",1,MODERNA,SYR 1046031,NC,66.0,M,"unable to take a deep breath, or any deep breath, with sharp pain under right shoulder blade. Symptoms were the same as previous pneumonia episode. also the body aches all over, somewhat severe. Body aches lasted 72 hours with decreasing after 24. Breathing lasted 96 hours with decreasing after 48.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/13/2021,1.0,OTH,"metoprolol, pantoprazole, montelukast, multi-vitamin, fish oil",none,a-fib,,"oxycontin, hydrocodine","['Arthralgia', 'Dyspnoea', 'Pain']",UNK,PFIZER\BIONTECH, 1046032,VA,46.0,F,"2/18/2021 injection site started to get itchy, 2/19/2021 little itchy still, a red circle of about 1 inch circumference of injection site appeared is also a firm bump, 2/20-21/2021 red circle of about 1 inch circumference of injection site and firm bump remains, 2/22/2021 bump is not as firm but slightly warm to the touch and still a red circle of about 1 inch circumference of injection site Have not taken any medications",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/18/2021,8.0,UNK,None,None,Born with a hearing loss,,Penicillin,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 1046034,TX,70.0,F,"Generalized rash to extremities 5 days after receiving 1st Moderna COVID-19 vaccine, treated with IM steroids.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/04/2021,3.0,PUB,Cholecalciferol (Dialyvite Vitamin D 5000) 5000 UNIT Oral Capsule Escitalopram Oxalate 5 MG Oral Tablet Start: 06/08/20 glucosamine Levothyroxine Sodium 50 MCG Oral Tablet Losartan Potassium 50 MG Oral Tablet magnesium asparate Metoprolol S,None,"HTN, hypothyroidism, OSA, GERD",,NKDA,['Rash'],UNK,MODERNA,IM 1046035,WV,71.0,M,"Within hours of the vaccine, broke out in bad itchy rash over most of body, including arms, over and under; sides, back, stomach, groin, down both legs to knee area.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,UNK,High blood pressure meds,None,Joint issues,,None,['Rash pruritic'],2,PFIZER\BIONTECH, 1046036,IL,34.0,F,"Becomes a little itchy, but not all the time, swollen, soreness, mild pain, redness, heat radiating off injection site with swelling...redness around 7 inches long. Had a low grade fever for only a day on Sunday 2/21/21. Pain all started on 2/20/21, a week later after receiving the Moderna vaccination. I have taken Ibuprofen and Benadryl and it has helped a little. Seeing primary doctor today on 2/22/21 for him to look at my arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,OTH,"Prescriptions: All taking the morning of prior to the time of vaccination - Losartan 25mg, Ezetimibe (Zetia), & Pantoprazole 40mg",,"heart condition - anomaly coronary artery, high blood pressure, high cholesterol, chronic colitis, Pelvic Floor Muscle Dysfunction",,"Sensitivity to Gluten, Morphine, NSAIDS, Sulfa, Percocet/Oxycodone, Nickel, Adhesive Tape","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Pyrexia']",1,MODERNA,SYR 1046038,OK,25.0,F,"Red rash appeared on left arm where the shot was given on day 10 after injection. The arm is red, warm, and slightly itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/20/2021,9.0,UNK,None,None,None,,Allergic to sulfa drugs,"['Injection site reaction', 'Pruritus', 'Rash erythematous', 'Skin warm']",1,MODERNA,SYR 1046039,MN,35.0,F,"Fever, aches, headaches, fatigue, sore throat, arm pain at injection site, diarrhea, nausea Started same day and have lasted a week",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/16/2021,0.0,PVT,"Trazadone, Sertraline, Tylenol, ibuprofen, vitamin D, probiotic",Common cold,None,,Dust and mold,"['Diarrhoea', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1046040,MD,76.0,M,Moderna COVID-19 Vaccine EUA Fever of 102.2 at 10 a.m. on the morning after the second dose,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,PUB,"Simvastatin, low dose of aspirin, vitamin D3, zinc",None,None,,None,['Pyrexia'],UNK,MODERNA, 1046041,NY,28.0,M,"Left arm pain, headache, weakness on date of vaccination. 2 Extra strength Tylenol taken. Symptoms improved next morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,SCH,,,,,,"['Asthenia', 'Headache', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 1046042,,70.0,F,"The patient received her first covid vaccine on Friday, 2/19/21. The patient did not complain of any ADRs or fever immediately following the injection. However, the next day (Saturday morning) she had a temperature of 100.2 F. Patient received acetaminophen 650mg and fever subsided. 6 hours later, the repeat temperature was 100.4 F and acetaminophen 650mg was given again. When vitals were checked again, her temperature was 98.6 F and remained afebrile for the rest of the weekend. She was not in distress. She had no complaints otherwise.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/20/2021,1.0,UNK,,,,,,['Body temperature increased'],1,MODERNA,IM 1046043,IA,37.0,M,"3.5 hours after vaccination = fatigue. 20 hours after vaccination = extreme fatigue, fever 101 (with Ibuprofen), chills, sweating, body aches. These symptoms lasted until 50 hours after injection. 4 days after injection, red, swollen, sore injection site on arm about 3""x6"".",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PHM,,,,,,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Injection site erythema', 'Injection site pain', 'Pain', 'Pyrexia']",2,MODERNA,IM 1046044,IA,29.0,F,"Two hours after injection, head ache started and felt very woozy. Nausea started in the afternoon. Around 10:00p body aches, chills, sore joints, feverish. At 2:30a cough and sore throat developed. Condition improved over next 24 hours. 2/16/21 was very fatigued, headache and nausea persisted, and body aches still present. Injection site was also swollen and hot to the touch. Symptoms continued to improve and were mild to nonexistent by 2/18/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,PHM,"Sertraline, Adderall XR, aurovela birth control",none,none,,none,"['Arthralgia', 'Chills', 'Cough', 'Dizziness', 'Fatigue', 'Headache', 'Injection site swelling', 'Injection site warmth', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",2,MODERNA,IM 1046045,NC,82.0,F,"Right after receiving the vaccine I had racing heartbeat for 2 hours. I was short of breath over the next few days. I developed a swollen and itchy arm. I developed dark bags under my eyes that made me look like I had ""black eyes"". My fingers turned purple. my veins in my hands and feet enlarged and looked green to me. I feel fine, I just have these funny things happening. everything started to go away after about 3 days and are almost normal except for the veins. I felt fine. then 3 days later on 2/15 I felt like I was going to faint, I felt a rush of heat like a fever and nausea. I felt fine by the end of the day. I am sleeping a lot. I also have a strange feeling in my foot that comes and goes for a few seconds.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/03/2021,0.0,SEN,Metropol Tarpis for afib,No,AFIB,,Antibiotics Penicillin Milk Wheat Nuts,"['Cyanosis', 'Dark circles under eyes', 'Dizziness', 'Dyspnoea', 'Heart rate increased', 'Hot flush', 'Hypersomnia', 'Nausea', 'Periorbital swelling', 'Peripheral swelling', 'Pruritus', 'Sensory disturbance', 'Vein discolouration', 'Vein disorder']",1,MODERNA,SYR 1046046,NJ,42.0,M,My siatica flared up on its own but has not gone away as it typically does. Jt occurred 12hr after the vaccine Typically it goes away but i still feel the leg numbness and my eife confirmed three werks later anf my left glut is swollen,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,PUB,,Costochronitis / pneumonia,Degenerative disk desiease Herniated disk Sleep Apnea,,Doxycycline / protonix,"['Condition aggravated', 'Hypoaesthesia', 'Muscle swelling', 'Sciatica', 'X-ray']",1,MODERNA,SYR 1046047,NJ,80.0,F,"injection site inflamation redness around injection about the size of a quarter, itchy with raised bumps, tin taste in mouth, irrated tongue. severe tiredness. sore arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/16/2021,1.0,PVT,"Valsartan/hctz, Synthroyd, Xarelto, Allegra",No,"Blood Pressure, Hypothyroid",,Penicilin,"['Dysgeusia', 'Fatigue', 'Glossitis', 'Injection site erythema', 'Injection site inflammation', 'Pain in extremity', 'Rash pruritic']",2,PFIZER\BIONTECH,IM 1046049,OH,50.0,F,"4:40PM PT STATES SHE 'FEELS LOOPY & MAY PASS OUT'. A/O X3, PINK, W/D, RESP REG WITH EASE. 5PM STATES 'FEELING BETTER'. CALLED BOYFRIEND TO DRIVE HER HOME. NO ACUTE DISTRESS NOTED. 5:20PM LEFT WITH BOYFRIEND.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,PUB,"ASPRIN, SINGULAR, LISINOPRIL, COREG, ATORVASTATIN",NONE,"ASTHMA, CAD, MI, FIBROMYALGIA",,"TORADOL, IMITREX","['Dizziness', 'Feeling abnormal']",1,MODERNA,IM 1046050,FL,69.0,M,"second day aches all day, severe chills lasted 1 hour then chills remainder of day and chills aches next. Day 3 chills and aches during day then 101 temp at night. Day 4 chills and aches stopped, unable to urinate sitting but could standing",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/20/2021,2.0,OTH,none,none,none,,none,"['Body temperature increased', 'Chills', 'Dysuria', 'Pain']",UNK,MODERNA, 1046051,MD,58.0,F,"Reported tingling tongue. Took own benadryl, monitored for 15 mins, noted resolution of symptoms and d/c home,",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,UNK,,,DM,,,['Paraesthesia oral'],UNK,PFIZER\BIONTECH, 1046052,MO,50.0,F,"02/14/2021 at 1130 am-I received my 2nd Dose of Covid Vaccine (Moderna) at work. Stayed at work for monitoring. I start getting dizzy and nauseated at 1330 and have told the provider about it. He questioned me if I had eaten anything, which I have not. So, I head home ate and took a nap. ? At 1000pm that night- I started having chills with Fever of 100 degrees, body aches. I took Tylenol 650mg 2 tabs and try to sleep. My fever broke at about midnight and was sweaty, groan and moan all night, ?coz of pain. ? 02/15/2021 at 0430am ? Started chilling again, with Fever of 101, severe body aches and joint pains, severe headaches. Took Tylenol 650mg 2 tabs around 5am. ? At 1100 am-Shivering, Fever 102 degrees, exploding headaches, joint pains, muscle pains, body aches, neck pain, diarrhea x 2, dizziness, nausea, extreme weakness, and little fingers are bending forward and painful. My headache was unbearable, I felt like my brain is going to explode. Tylenol 650mg 2 tabs taken. Ice compress to forehead and back of neck applied. Called Dr office which I was told to be in the clinic office at 1330 and I will be consulting with Dr instead. ? At the Clinic- I was told that I was having bad reactions from the Covid Vaccine and my symptoms will be treated as if I have ?Covid?. My Blood pressure was 150/100 as I am extremely in pain. He gave me a Toradol shot 1st thing and let me rest for about an hour with lights off. By then, my pain were tolerable including my headache. He gave me Medrol Dose (steroid) shot and Rocephin shot then. I was instructed to come back in the Clinic for f/u the next day. He wants to monitor me closely as he has seen uneventful cases of this that leads to death. He sent me a dose of Toradol for pain to be given between about 11pm if needed for pain. ? At 11pm -Started having chills again with fever of 100 degrees. My body aches/joint pain started to intensify and my head starting to ache. Took Tylenol 650mg 2 tabs for fever. My Sister who?s a Nurse gave me the IM shot of Toradol dose prescribed by the doctor. I was able to sleep all night without interruptions, but woke up with clothing wet because of too much sweats. ? 02/16/2021 at 0830-My body aches/HA are under control, but still extremely weak. As I was getting ready for 1000 am Doctor?s follow up. I started getting short of breath with simple activities such as dressing and walking. By the time I got to the office I am very much short of breath, but my oxygen Saturations has been staying up above 90?s. He gave me an inhaler to ease my breathing. Prescribed me Dexamethasone and Azithromycin, Symbicort. He?s not releasing me to work until he sees me in a week, schedule for 02/22/2021. ? At 11pm that night- started to have mild chest pain lasted about 30 minutes. I took Ibuprofen 600mg and force myself to sleep. I roughly sleep that night. ? 02/17/2021 at 0930-Start having increased Short of breathe with talking, walking, dressing (simple activities). My lungs felt bruise and painful, but I have no cough nor phlegm. My headaches are back with intensity of 9/10. I felt very exhausted as I gotten up at 0500 and felt like I have not slept and unable to rest/calm my mind. Started having chest pain again on and off. I took all the prescribed medications and inhalers. My BP 149/98, Pulse 108, R 22, T 98 Spo2- 96%. Started having chest pain again on and off. My short of breath has ease a little at rest and after inhalers usage. ? 3:00pm-Gotten up to check Vital signs BP- 138/82, P-100, R 20, T 97.8, Spo2-95%. Lungs still painful, breathing?s better, headaches still there annoying but tolerable. Then I started seeing floater?s in my eyes. Checked Blood sugar-131. 02/18/2021- I feel like 60% better with breathing. However, I?m very weak and easily fatigue. Needs intermittent rest every 2-3 hours. My voice seems to be fading, can only speak in soft volume voice as if not enough strength with my vocal voice. 02/19/2021- Called Dr office for update of my condition and was told to come to Clinic at 5pm. EKG was done in clinic , spirometer. Due to new onset of chest pain and EKG result. Doc suggested direct admission for more lab works, cardiac work out and CXR. I was direct admitted at Hospital at 6:30pm at Cardiac/Telemetry unit. 02/20/2021 ?See data?s/documentations from hospital. I was discharged at 8:30pm to home. To f/u with Dr on Monday the 22nd. As I arrived home, I ate a little then vomited a lot. 02/21/2021- I have massive abdominal cramps with diarrhea. Very dizzy and very weak still, but no more short of breath at this time. My voice seems to be coming back to normal volume.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/14/2021,02/14/2021,0.0,OTH,"Amlodipine, omeprazole, aspirin 81mg, Vit C, Vit D, Tylenol",None,Asthma HTN,"Dizziness, mild chest pain, mid spine pain, back of neck pain, headaches, body aches,",Augmentin IV antibiotics Cat hairs Molds,"['Abdominal pain', 'Aphonia', 'Arthralgia', 'Asthenia', 'Blood glucose increased', 'Cardiac stress test', 'Chest X-ray', 'Chest pain', 'Chills', 'Diarrhoea', 'Dizziness', 'Dyspnoea', 'Dyspnoea exertional', 'Echocardiogram', 'Electrocardiogram abnormal', 'Electrocardiogram ambulatory', 'Fatigue', 'Head discomfort', 'Headache', 'Hyperhidrosis', 'Impaired work ability', 'Laboratory test', 'Loss of personal independence in daily activities', 'Moaning', 'Myalgia', 'Nausea', 'Neck pain', 'Pain', 'Pain in extremity', 'Pulmonary contusion', 'Pulmonary pain', 'Pyrexia', 'Restlessness', 'Sleep disorder', 'Speech disorder', 'Spirometry', 'Trigger finger', 'Vaccination complication', 'Vitreous floaters', 'Vomiting']",2,MODERNA,IM 1046054,CO,61.0,F,"Arm at site of injection swelled, sore, broke out in hives and itches Had strawberries and blueberries 2 hours before reaction",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/21/2021,10.0,SCH,daily multi vitamins Tylenol elderberry Blood pressure herbal vitamins tumeric,none,none,,Shrimp Sulfa drugs,"['Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria']",1,MODERNA, 1046055,MI,90.0,F,"AFTER 5 MINUTES AFTER RECEIVING THE VACCINE, SHE COMPLAINED OF BEING WEAK. ONSITE EMS RESPONDED. SHE WAS EVALUATED BY EMS AND TRANSPORTED TO A LOCAL HOSPITAL FOR FURTHER EVALUATION. VITALS BELOW",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,PUB,"ASPIRIN, METOPROLOL, FELODIPINE, SIMVASTATIN, TIMOLOL",,SHE HAS LONG TERM HEALTH PROBLEMS,,PENICILLIN,['Asthenia'],2,MODERNA,IM 1046056,AZ,66.0,M,"Please help be get a replacement shot. This was a drive-through vaccination, and only the second shot of the day by the volunteer doctor. She was flustered (in fact, she even dropped a needle on my lap through the car window). She reached through the window, squeezed the inner side of my arm, raising the fat, and then injected the dose at a 45 degree angle. I thought it was weird that it was so different than the hundreds of images we've seen on the news, but figured she knew what she was doing, until I researched it at home. She automatically did a subcutaneous fat injection. How can I get signed up for a replacement of that Dose 1? Please help. FYI: I had NO reactions, not even a sore arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,OTH,"N/A (this was an administration error, not an adverse reaction)",none,CKD,,"N/A (this was an administration error, not an adverse reaction)",['Product administration error'],1,PFIZER\BIONTECH,SC 1046057,AZ,66.0,F,"Body aches, fever 99.8, chills, chattering teeth, general feeling unwell. Pounding headache, fatigue, really sore arm. Night sweats. Lasted about 48 hours. I'm still waking up with a pounding headache every morning. Still lingering sense of unwellness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,OTH,Losartin 50 mg daily venlafaxine 37.5 mg every other day vitamin D vitamin C multivitamin,No,hypertension,,sulfa,"['Chills', 'Fatigue', 'Headache', 'Malaise', 'Night sweats', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 1046058,NC,60.0,M,"Mile to moderate tinnitus predominately in the right ear, but sometimes also sensed in the left. The sensation began within 5-10 minutes of the injection and continues to date. The intensity of the ringing varies, and seems a bit less pronounced as time goes by.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,SEN,"See Continuation Page; Prescriptions, over-the-counter medications, dietary supplements List: Glaucoma Dorzolamide HCl/Timolol Maleate Ophthalmic Solution � 22.3 mg/6.8 mg per mL (1 drop, 2 x day, both eyes) Zioptan (Tafluprost Ophthalmic",None,"Glaucoma, Migraines",,None Known,['Tinnitus'],1,MODERNA,IM 1046059,NY,30.0,F,"Day after vaccination-- At 3:45:Whole-body fatigue/soreness. Before 4pm, chills. At around 5:30pm: Fever (101.2-102.6F). Drank plenty of fluids and stayed in bed with multiple blankets for over 14 hours - in and out of sleep (mostly sleep).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,UNK,Vitamin D supplement (50 mcg daily),None,Type 2 Diabetes,,none,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",UNK,MODERNA,SYR 1046060,FL,71.0,F,"Feb 11, sore arm for one day; Feb 17 started with muscle and joint pain, especially tender right knee and overall not feeling well; Feb 18 felt lightheaded and weak with standing through out the day; Feb 19 weakness and lightheaded much worse, had several episodes of vomiting and become too weak to stand; went to ER",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/17/2021,6.0,OTH,"Vitamin D 1,000u twice a day; B12 500mg daily; Magnesium 400mg daily",none,Occasional PVC's diagnosed in Sept 2019; Mutated ATM gene (from one parent); Mucinous breast cancer Stage 1,,"Vibramycin, cranberries, cherries","['Arthralgia', 'Asthenia', 'Dizziness', 'Dysstasia', 'Electrocardiogram abnormal', 'Extrasystoles', 'Full blood count normal', 'Metabolic function test normal', 'Myalgia', 'Myocardial necrosis marker normal', 'Pain in extremity', 'Urine analysis normal', 'Vomiting']",1,PFIZER\BIONTECH,IM 1046061,VA,69.0,F,"After my vaccine, I had problems breathing for about 5-10 minutes. My symptoms were different this past two weeks. I experienced nausea, dizziness, felt like my brain was on fire. Last week I could not comprehend what people were saying, I did not understand. Extreme irritation, anxiety, depression. Fatigue and tiredness, my legs are weak. My blood pressure went skyrocketed: 169/80.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/06/2021,0.0,PUB,"Zoloft, Synthroid, Vitamin D3, Fish Oil, DGL, Nutramedix: Burbur, Pinella, Ezov,",NONE,Chronic Lyme,,"Pencillin, Latex, Bacterim, Iodine,","['Anxiety', 'Blood pressure increased', 'Burning sensation', 'Depression', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Irritability', 'Language disorder', 'Muscular weakness', 'Nausea']",1,PFIZER\BIONTECH, 1046062,PA,76.0,F,"Delayed reaction -- EIGHT DAYS AFTER my innoculation, I developed some swelling and itching in my upper left arm around the injection site. The area is oval shaped, about 2 by 3 inches, and the skin is pink. The swelling and itching have abated somewhat in the last 36 hours but not disappeared completely. I have twice applied ice to the area briefly, but have taken nothing else for the swelling and itching. I had no other reaction to the shot except slight soreness only the day after the shot. I find it strange that this swelling & itching arose so much later (8 days).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/20/2021,8.0,PVT,"daily multivitamin, calcium +D, Prolia (once every 6 months) by injectionno",none,osteoporosis,,none known,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 1046063,CA,67.0,M,Herpe infection flare up above upper lip right side.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/22/2021,2.0,OTH,bupropion XL 150mg loratadine 10mg,,,,,"['Herpes virus infection', 'Oral herpes']",1,PFIZER\BIONTECH,IM 1046064,IA,51.0,F,"1st dose no symptoms 2nd dose arm sore couldn't move it, headache, chills, fatigue, no appetite",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PHM,"Metformin, Atorvastatin, Amlodipine, Hydrochlorothiazide, Losartan, Women One a day vitamins, Caltrate calcium",None,None,,Contrast,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Mobility decreased', 'Pain in extremity']",2,MODERNA,SYR 1046065,MI,56.0,F,"Redness, swelling itching warm to the touch. 7 days after",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,PHM,Bupropion 150mg 2x daily Bystolic 10mg 1x daily Cetirizine 10mg 1x daily Hydrochlorothiazide 25mg 1x daily Omeprozole 20mg 1x daily Progesterone 200 mg daily Ibuprofen 800 mg 2x daily EstroDim 1x daily Magnesuim 500mg 1x daily Calciu,None,COPD,,Bees/wasps,"['Erythema', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,SYR 1046066,IL,80.0,F,left upper arm redness and swelling 2 weeks after 1st covid vaccine. sx continue to progressively worsen within the past 24 hours of onset otc acetaminophen given with improvement in pain patient prescribed triamcinolone cream and cephalexin,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/18/2021,14.0,OTH,"acetaminophen otc, Depakote ER, Aricept, duloxetine, levothyroxine, Ritalin, oxybutynin, vitamin D3, coumadin",seen in office on 1/28/2021 for issues with dizziness and postural hypotension,"Essential hypertension Lymphedema of right upper extremity Other specified forms of chronic ischemic heart disease Palpitations Paroxysmal atrial fibrillation Pericardial effusion Syncope Endocrine Diabetes type 2, uncontrolled Family history of malignant neoplasm of ovary Hypothyroidism Pure hypercholesterolemia Respiratory Diaphragmatic hernia Pulmonary nodules Gastrointestinal Acute peptic ulcer Benign neoplasm of stomach Esophageal reflux Other dysphagia Renal / Genitourinary Other specified congenital anomaly of kidney Urge incontinence Breast Problems Breast cancer, left breast, pT1cN1aM0, ER-, PR-, HER2 3+ Breast cancer, right breast, pT2N2aM0, ER-, PR-, HER2 3+ Neurologic Convulsions Dementia without behavioral disturbance Dizziness and giddiness Subarachnoid hemorrhage Traumatic intracranial hemorrhage without loss of consciousness Musculoskeletal Closed fracture of eighth thoracic vertebra Closed fracture of first cervical vertebra Closed odontoid fracture Fracture of eleventh thoracic vertebra Ingrowing nail Osteoporosis Statin myopathy Swollen L ankle Infectious Disease Other viral warts Dermatologic Dermatophytosis of nail History of basal cell carcinoma Onychomycosis Other History of benign neoplasm of brain",,"latex, hydrocodone-acetaminophen, and phenytoin","['Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 1046067,NY,71.0,F,"Itchy Rash (small pumps) around injection side - continues to expand - darker red around edges than in center currently (2.22,21) about 5 inches long and 3.5 inches wide",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/18/2021,6.0,PHM,"Losartan, Atovastatin, multivitamin, Calcium and Vitamin D",,,,sulfa drugs,"['Injection site rash', 'Rash pruritic']",1,MODERNA,IM 1046068,ME,33.0,F,Swollen bleeding right tonsil. 2 days after dose. Saw pcp. Tested for strep. Negative test. Placed on penicillin for 10 days. Felt better after being on pcn for 7 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/24/2021,2.0,PVT,Vitamin c. Multivitamin,,,,,"['Streptococcus test negative', 'Tonsillar haemorrhage', 'Tonsillar hypertrophy']",1,MODERNA,IM 1046069,SC,72.0,M,Have artificial right knee. Day after shot starting getting pain in knee. Still have pain today 2/22/2021 2 days after shot. Don't know if related but have not had pain in this knee for the last 7 years.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,PVT,Acetaminophen 500mg 2 caplets,none,RA,,none,['Arthralgia'],1,MODERNA,SYR 1046070,MD,41.0,F,"itchiness along left side, pain in neck on left side, itchiness of the lips, minor swelling in tongue and throat",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,PVT,Bupropion HCL XL 450mg Sertraline HCL 50mg Lo loestrin Tylenol,none,none,,"dust, ragweed, pollen","['Lip pruritus', 'Neck pain', 'Pharyngeal swelling', 'Pruritus', 'Swollen tongue']",2,PFIZER\BIONTECH,SYR 1046071,FL,45.0,F,"difficulty breathing, desats, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Dyspnoea', 'Pyrexia']",1,MODERNA,IM 1046072,CO,71.0,F,injection site swelling injection site redness injection site itching,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,OTH,"Vitamin c, Vitamin D, multi, selenium, calcium, magnesium, feverfew, elderberry, glucosamine, bilberry",,,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",2,PFIZER\BIONTECH,IM 1046073,WV,44.0,F,I started feeling really tired (couldn't move type tired). I called off worked for few days. On the 1/7 noticed right of my face was drooping about 10 days couldn't smile and wiggle both ears.For me to talk it was very difficult due to right side of my face being so weak. I went to walk in clinic was diagnosed with Bell's Palsy. As of today I still couldn't lift my eyebrow (right) and smile still slightly cooked.,Not Reported,,Not Reported,Yes,,Not Reported,,01/05/2021,01/06/2021,1.0,PVT,"Aspirin,Vit D, Fish Oil, Metformin,Levothyroxine, Lexapro, Buspar, Fenofibrate, Lantis, Humalog",No,"Diabetes, High Blood Pressure, Cholesterol",,Levaquin,"['Aphasia', 'Facial paralysis', 'Facial paresis', 'Fatigue', 'Impaired work ability']",1,PFIZER\BIONTECH,IM 1046074,,65.0,F,"Redness appeared on left arm around injection site on the 8th day post vaccination. Online references described as ""Covid Arm"". As of 9th day post vaccine, no related pain or itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PHM,OTC supplements: Women over 50 daily multi-vitamin B6/B12 Lutein Nicotinamide 500mg Dindolymethane 100mg,None,None,,None,['Injection site erythema'],1,MODERNA, 1046075,MD,67.0,F,This reaction was immediate and I am concerned about taking the second dose. can I go to a medical facility to receive my second shot.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,OTH,Levothyroxine Sodium 137 mg Vit B-12 500 mg' vit B-6 100mg Vit D- 3 400 mg fish oil 1200 mg asprin 81 mg Polycarbofil 3 X 4 grams Simvastatim 40 mg-night before. Zolpiderm 5 mg - night before,None,Over weight arthritis,,"Doxycycline Hydrate 100mg - hives, headache and arm paralysis Levofloxacin 750 MG - hives and headache Keflex - hives Covid 19 - Pfizer 1st dose shot - Immediate Pain , swelling and some paralysis , hives within 3 minutes. MSG - swelling of colon , pain cramping IBS",['Unevaluable event'],1,PFIZER\BIONTECH,SYR 1046076,CT,60.0,F,"Injection site is bruised. Developed a red, raised rash below the injection site on the 8th day after vaccination. The rash has remained for 3 days so far. It?s less raised but has spread around the injection site. Developed swollen lymph nodes under the left armpit on the 10th day after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/20/2021,8.0,PVT,Source Naturals Wellness Formula,,,,Sunflower seed oil,"['Injection site bruising', 'Injection site reaction', 'Lymphadenopathy', 'Rash erythematous', 'Rash papular']",1,MODERNA,IM 1046077,AZ,46.0,F,"aches, chills and headaches after the second COVID-19 vaccine but those symptoms are mild to moderate. the symptom were for about two days.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/21/2021,1.0,PUB,"dayquill , night quill and ibuprofen",none,none,,none,"['Chills', 'Headache', 'Pain']",UNK,MODERNA,IM 1046078,CT,72.0,M,"Exhaustion, very tired, slept almost all day long",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/10/2021,1.0,PVT,"Asprin 81mg 2/day, Bydureon Boise 2mg 1/wk, Hydroxycloroquine 200 mg 1/day, Metformin Hcl 1000mg 2/day,Metoprolol Succinate ER 50mg 1/day, Midardis 20 mg 1/day. Sim a statin 20 mg 1/day",,"3 stents, Type two diabetic, High BP, High Cholesteral, Over weight,",,Surgical cat gut,['Fatigue'],UNK,MODERNA,SYR 1046079,NY,42.0,F,itching 10 minutes after administration of vaccine no tongue or lip swelling benadryl 50 mg X1,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,OTH,"Losartan HCTZ, Ambien prn, Effexor XL, Clonopin, Vicodin PRN","HTN, Anxiety",same as above,,"Codeine intolerance, demerol lupron chichen , baker's yeast, blue cheese, peanuts",['Pruritus'],1,PFIZER\BIONTECH,IM 1046080,MI,32.0,F,"some mild fatigue that last a few days after injection, site pain 12 hours following shot that lasted about 24 hours. Upset stomach on 48 hours after vaccination, cramping, lose stool. Did not cause nausea or vomitting. resolved within 24 hours. No other symptoms. did not seek care.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/20/2021,2.0,PVT,"Zoloft, 35 mg, Vitamin D, melatonin and Magnesium supplements",none,none,,allergic to sulfa - rash,"['Abdominal discomfort', 'Diarrhoea', 'Fatigue', 'Injection site pain', 'Muscle spasms']",1,MODERNA,SYR 1046082,IA,38.0,F,"Onset of chills the evening of the injection. The following day, approximately 21 hours after injection developed worsening aches and chills. Fatigue started around 1400 the day after injection (2/19/21). That evening diarrhea, nausea and vomiting progressed. Debilitating nausea occurred all day on 2/20/21. Diarrhea remained until 2/22/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,PVT,Zyrtec 10mg Prenatal Vitamin Caltrate Vit D3 2000iu,,,,Sulfa Reglan,"['Asthenia', 'Chills', 'Diarrhoea', 'Fatigue', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,IM 1046083,NC,57.0,M,I had right sided chest pain that was non radiating. It was localized pain between the sternum and the right breast that would last for 5-10 seconds. It was irregular as far as when the pain would return.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PUB,No,No,No,,No,"['Chest X-ray normal', 'Chest pain', 'Computerised tomogram normal', 'Electrocardiogram normal', 'Fibrin D dimer increased', 'Pain']",1,MODERNA, 1046084,NM,84.0,F,Severe headache. Nausea. Vomiting. Tired. Difficulty concentrating.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/14/2021,13.0,PVT,"Duloxatine, Trazadone, Topimirate, Tylenol, Ibuprofen, multivitamin",headache,"Migraine headaches, depression",,Penicillin,"['Condition aggravated', 'Disturbance in attention', 'Fatigue', 'Headache', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH, 1046085,WA,63.0,F,5-6 raised lesions that were red and itchy near site of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PVT,"OTC thyroid supplements, calcium and multivitamin",None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 1046086,NJ,17.0,M,Vaccine administration error - patient is a 17 year old and vaccine received EUA for 18 years of age and older.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PVT,,,,,None,['Product administered to patient of inappropriate age'],1,MODERNA,IM 1046087,NY,32.0,F,"PATIENT REPORTS THROAT TIGHTENING , ITCHY, AND SWOLLEN. CHEST TIGHTNESS UPON INHALATION. EPI ADMINISTERED IN LEFT THIGHT, ORAL BENEDRYL ADMINISTERED 50MG. EMERGENCY SERVICES CALLED AND TRANSPORTED TO HOSPITAL.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,OTH,ANTIDEPRESSANTS,NONE,UNKNOWN,,BLEACH,"['Chest discomfort', 'Pharyngeal swelling', 'Throat irritation', 'Throat tightness']",2,MODERNA,IM 1046088,TX,29.0,F,"Bell's Palsy -loss of muscle movement in left side of face, numbness in tongue, pain in neck. Began on 2/18 with numbness, woke 2/19 with no control of facial muscles Received steroids and antivirals, no improvements",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/18/2021,20.0,PVT,IUD Vitamin D supplement Multivitamin,N/a,Asthma,,Penicillin allergy Bee venom allergy,"['Facial paralysis', 'Hypoaesthesia oral', 'Neck pain']",1,PFIZER\BIONTECH,SYR 1046089,CA,38.0,F,"Covid arm- rash at site of injection a couple days after it was given. Itchy, hot to touch, swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/20/2021,2.0,PVT,"Birth control, levothyroxine, fluoxetine, Zyrtec",None,"Allergies, hypothyroidism, depression",,"Fruit, nuts,","['Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site warmth']",UNK,PFIZER\BIONTECH, 1046090,NY,71.0,F,"Moderna COVID-19 Vaccine EUA A few hours after I received the vaccine I had a circular rash around the injection site which lasted about four days. The rash disappeared, but the area continued to be a hardened. Last night the rash reappeared and the itchiness returned. From information I have read this is a reported side effect. I wondered how long it will last. My second dose is March 11. Should I have the injection in my other arm?",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/21/2021,11.0,PHM,"losartin, simvastatin, fish oil, Women's One-A-Day vitamin, vitamin C, vitamin D, Citracal, low dose aspirin, glucosamine with chondroitin (Movewell), magnesium, melatonin",none,"high blood pressure, cholesterol, arthritis",,none,"['Injection site induration', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 1046091,,82.0,F,Had major vertigo on my first shot. Saturday i felt the feeling like i was off the floor again . not so much vertigo but like i was floating. yesterday i ate lunch and very quickly after i got diarrhea very suddenly and i felt i emptied my entre body This morning i have had pain in my stomach but seems to be subsiding as the day goes on.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/20/2021,3.0,PVT,"TZH- hydrochlorosizide 12.5 MG, Levothyroxine,",,,,Some antibiotics,"['Abdominal pain upper', 'Diarrhoea', 'Feeling abnormal']",2,PFIZER\BIONTECH,IM 1046092,NJ,53.0,M,"Muscle soreness and weakness, minor fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PUB,Amlodipine 5mg Valsartan 40mg Doxepin 10mg Aspirin 81mg,DNA,Hypertension,,None,"['Fatigue', 'Muscular weakness', 'Myalgia']",UNK,MODERNA, 1046093,,38.0,F,All over body rash Swelling with eyes,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,SCH,cymbalta celebrex flexeril,none,lower back pain/arthritis,,none,"['Eye swelling', 'Rash']",UNK,MODERNA, 1046094,CA,28.0,F,"First dose 12/28/2020. On 01/05/21 patients states arm was throbbing at injection site, and that same night and next day her joints started hurting. On 01/06 she states her hands were swollen the size of sausages. She consulted a MD who is rulling out RA. Lab work ordered and a specialist consulted who thinks it is covid vaccine related. Patient also states numbness in both hands. Patient received 2nd dose on 01/25/21 with a remarkable reaction of fever of 102 for 3 days, sore throat, headache, dizziness, loss of appetite, loss of taste and loss of hearing in right ear. After further consultation, patient tested negative for COVID. Patient states she continues to wake up with sore hands and slight swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/05/2021,8.0,UNK,None,"Liver Failure, Kidney failure,",Kidney stones,,Unsure - pineapple or cauliflower,"['Deafness unilateral', 'Decreased appetite', 'Dizziness', 'Headache', 'Oropharyngeal pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'SARS-CoV-2 test negative', 'White blood cell count increased']",2,MODERNA,IM 1046095,MD,92.0,F,"Chills, fever (101); arm sore all night; could not sleep; took Tylenol to bring temp down; nose was running; did not feel like eating; feeling much better today; no fever, chills, temp normal",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PVT,Blood Pressure meds; allopurinol; blood thinners,s/p TAVR 03/04/2019; hbp; gout,heart murmur; rheumatic heart disease; valve replacement; occasional gouty attacks in joints,flu; maybe two or three years ago; arm got inflamed,Penicillin; kiwi/strawberry,"['Chills', 'Decreased appetite', 'Pain in extremity', 'Pyrexia', 'Rhinorrhoea', 'Sleep disorder']",2,MODERNA,SYR 1046096,FL,67.0,M,"More than a week after injection 4"" vertical by 3"" horizontal red, swollen, tender area appeared has persisted for four days so far.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/19/2021,11.0,PHM,Acetaminophen Albuteral Sulfate Asprin Azelastine Nasal Spray Baclofen Carvedilol (Coreg) clobetasol propionate cream Guaifenesin (Long Acting) Humalog Iron Levothyroxine Magnesium Citrate Ozempic Pantoprazole (Protonix) Pravastatin Sodium,,"Asthma, Type 2 Diabetes, Chronic Kidney Failure",,"Meta-bisulfides, animal dander, pollen, dust mites, and mold","['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 1046097,AZ,41.0,F,Notice about 3 days after vaccine large painful lump in Left breast. By day 5 it was bigger and very painful. The lump took over a week to soften and go away. I am still tender with some swelling in the arm pit lymph notes.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/31/2021,3.0,PVT,"zyrtec, multivitamins, protonix",none,Seborrhea-Psoriasis,,"compazine, pineapple","['Breast inflammation', 'Breast mass', 'Breast pain', 'Lymphadenopathy', 'Mammogram abnormal', 'Tenderness', 'Ultrasound scan abnormal']",1,PFIZER\BIONTECH,IM 1046098,UT,65.0,M,pt stated he felt some immune response but no fever after receiving. Pt said he developed a painful rash under left armpit. He contacted his PCP and he was told to use cortisone and send her a picture of it tomorrow to see if it needs further treatment.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,PHM,"Cymbalta, Crestor, Vitamin D, Fish Oil, OQ10",no,Chlorestoral,Shingrix vax 5 years ago- fever and chills w/ 2nd dose.,no,['Rash'],1,MODERNA,IM 1046099,KS,66.0,F,"I have been vomitin for the last 4 days with a lot of abdominal pain.. Can keep sips of liquid down but increases pain. I have 2 sisters that have had reactions to this, also. One is very similar to my reactions.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/18/2021,2.0,OTH,None,None,Diabetes,Tetnus,Erythromycin Keflex. Iodine. Bee stings. Celery,"['Abdominal pain', 'Vomiting']",UNK,MODERNA, 1046100,ID,46.0,F,I woke up on Friday morning (shot was Wednesday afternoon) covered from head to toe in a massive rash. We are now going on day four with this rash and it isn't getting better yet at all. I'm taking prescription strength antihistimines and using topical steroid creams. It is getting redder and itchier as time goes on. I've been to urgent care twice.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/19/2021,2.0,OTH,Humira Finastra,none,,,"Penicillin, Cipro, Mango","['Rash', 'Rash erythematous', 'Rash pruritic']",2,MODERNA, 1046102,TX,45.0,F,"within few hours, extreme chills next morning-chills, body aches, headache, fatigue-took tylenol this lasted for days. by day 7 it got better. but then developed sinus congestion, sneezing-blocked sinuses causing loss of taste/smell.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/15/2021,0.0,PHM,"vitamin D, vitamin c, zinc, probiotics,",large canker sores,none,,gluten sensitive,"['Ageusia', 'Anosmia', 'Chills', 'Fatigue', 'Headache', 'Pain', 'Sinus congestion', 'Sneezing']",1,MODERNA,IM 1046103,NM,76.0,F,"On Feb. 13th, I had a red spotty rash on my upper chest and breasts. It is still spreading all over my body.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/13/2021,14.0,PVT,"Atenolol, Hydrochlorothiazide, L-Thyroxine,, aspirin, mutivitamins, calcium, B-complex and C. None of my prescriptions have changed for at least 5 years.",None,Hypothyroid and hypertension,,"morphine, sulfa drugs and numerous antibiotics. I have not used any of these products","['Rash', 'Rash macular']",UNK,MODERNA,IM 1046104,,31.0,F,"nausea, vomiting, fatigue, HA, dizziness, Bel's Palsy",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/08/2021,02/10/2021,2.0,UNK,,,,,,"['Dizziness', 'Facial paralysis', 'Fatigue', 'Headache', 'Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH, 1046105,NC,50.0,F,"Received the 2nd shot on 2/11/2021. I started feeling a little ""off"" later in the evening. I woke up at 0300 with severe joint pain, headache and chills. Nausea started shortly afterwards. The joint pain was excruciating and it was very difficult to move. By 0330, I started vomiting. Vomiting continued until approximately 0745. I felt dehydrated but was not able to hold down any water. I contacted the Nurse Advice line and spoke to a nurse. She asked me a series of questions, all relating to signs indicative of an allergic reaction. I knew I was not experiencing a typical allergic reaction. But I was experiencing a bad reaction. Based on my responses to her questions, she did not recommend that I go an Urgent Care Clinic or see a Doctor. The severe joint pain continued through 02/14/2021. I started to feel better on 02/15/2021. Even though I did not experience an allergic reaction, given the severity of my joint pain and vomiting, I still feel it is important for what I did experience to be documented. Thank you.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/12/2021,1.0,MIL,,,,,Poison Ivy,"['Arthralgia', 'Chills', 'Dehydration', 'Feeling abnormal', 'Headache', 'Mobility decreased', 'Nausea', 'Pain', 'Vomiting']",2,PFIZER\BIONTECH,IM 1046106,,79.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Incorrect dose administered'],2,PFIZER\BIONTECH,IM 1046107,ND,54.0,F,I developed sudden onset generalized severe abdominal pain with bloating. I followed a full liquid diet and saw my provider on day 3 of the pain. Lab work was done as well as a stat CT scan of the abdomen. I remained on liquids only for approximately 6 days and the pain eventually lessened each day and then subsided.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,02/01/2021,6.0,WRK,"HCTZ 25mg daily, Ibuprofen 600mg PRN",,HTN,,Nubaine,"['Abdominal distension', 'Abdominal pain', 'Computerised tomogram abdomen normal', 'Metabolic function test normal']",UNK,MODERNA,IM 1046108,VA,84.0,M,"A short time after the injection a tingley, prickley feeling went down both arms and legs to my hands and feet. I felt normal otherwise. The intensity varies but is always there. My doctor could find no serious problem and suggested a possible B12 connection and ordered a blood test. The test showed my B12 went from around 200 to over 1000.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/06/2021,0.0,PVT,B12 Pill,None,None,,"Novacain, tobacco","['Paraesthesia', 'Vitamin B12 increased']",1,PFIZER\BIONTECH,SYR 1046109,CA,86.0,F,"48 hours after the injection, patient had difficulty standing, walking, and had severe weakness. She was unable to stand for more than 5 minutes. Unable to put on her shoes, make her food, and needed assistance with dressing. She has improved over the week but still has difficulty with meals and dressing. Is able to walk for a few minutes and uses a walker and a wheelchair for longer trips.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/14/2021,2.0,PUB,"diltiazem, prardaxa, synthroid, carbidopa Supplements: methyl CpG, curcumax (ionga root,rhizome extract, boswelia serrata gum, 3-0-acetyl-11-ketobeta-bosellic acid (AKBA) alpha-glycosyl isoquercitrin) Folic acid, Duozyme(Betaine HCL, Glut",none,"Parkinson's Disease, Atrial Fibrillation, hypothyroidism,",,None,"['Asthenia', 'Dysstasia', 'Gait disturbance', 'Loss of personal independence in daily activities', 'Walking aid user', 'Wheelchair user']",2,PFIZER\BIONTECH,SYR 1046110,MI,37.0,F,101 fever lasted 15 hours Chills lasted 15 hours Overly tired lasted 30 hours Migraine lasted 30 hours Stuffy nose lasted 12 hours Whole body aches lasted 12 hours Frequent urinating lasted 9 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,SCH,Ibuprofen,None,None,,Peanuts and Vicodin,"['Chills', 'Migraine', 'Nasal congestion', 'Pain', 'Pollakiuria', 'Pyrexia']",2,MODERNA,SYR 1046111,SC,76.0,F,"Patient reports she got her COVID vaccine around 5:30 P.M. and approximately 20 minutes later developed airway and tongue swelling. EMS arrived and she was given 0.3 mg IM epinephrine, 125 mg solumedrol, 50 mg benadryl, 2.5 mg versed for anxiety. Patient states she is not much better since receiving it, however per EMS she was doing much better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,OTH,"alendronate, alprazolam, clonazepam, duloxetine, fexofenadine, fluticasone propionate, folic acid/multivit-min/lutein, nitroglycerin, polyethylene glycol, rosuvastatin, and vit c/e/zn/coppr/lutein/zeaxan.",none known,"PMHx: has a past medical history of Abnormal Holter exam (4/2006), Anxiety, Deep vein thrombosis (HCC) (8-20-15), Depression, Dyslipidemia, Fibromyalgia, Fibromyalgia, H/O mammogram (06/2020), Murmur, Osteoporosis, PFO (patent foramen ovale), Stroke (HCC) (2013, 2016), Supraventricular tachycardia (HCC), and TIA (transient ischemic attack) (1995).",,Clindamycin Avacado Penicillins Ondansetron,"['Pharyngeal swelling', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 1046112,,82.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Incorrect dose administered'],2,PFIZER\BIONTECH,IM 1046113,PA,53.0,F,"Within 6 hours of vaccination, intense pain in the right arm - could not lift it overhead without pain. This continued - and got worse on Friday morning. The Friday morning event is what I am reporting. I got up to shower; put shampoo in my hair and then conditioner. My right arm was hurting so badly that I was having trouble rinsing my hair. Then I felt faint and nauseous. Got out of the shower and fell onto the bed in the bedroom. Woke my husband to tell him that I was feeling badly - faint and the whole room was spinning. Then I felt my airway closing. He went down to get my levalbuterol (rescue inhaler); took one puff and that opened my airways. I was still weak and he had to help me get dressed. (BTW- I'm a competitive athlete/ swimmer.) I held onto him going downstairs. I was not hungry though did eat a bit. I spent the day on the couch with the chills and the room spinning until early afternoon. By Saturday I was starting to feel better. The pain in my arm mostly subsided by Sunday and I went to swim practice. It wiped me out for the entire day and I spent the rest of Sunday on the couch. It's now Monday morning. I am feeling a bit off but better. I am concerned about getting the second shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/19/2021,2.0,OTH,Daily vitamin Nasacort Symbicort Levalbuterol Zyrtec,Asthma,Asthma Seasonal Allergies,,Neomycin,"['Asthenia', 'Chills', 'Decreased appetite', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Injected limb mobility decreased', 'Nausea', 'Obstructive airways disorder', 'Pain', 'Pain in extremity', 'Vertigo']",1,MODERNA,IM 1046114,WI,72.0,M,"Redness, slight swelling, warm to touch, itchy, approximately four inch diameter, very irregular shape. Persists since onset. No treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/18/2021,12.0,PUB,Alfuzosin (UROXATRAL) AVODART (dutasteride) Betamethasone cream Bisoprolol fumarate (ZEBETA) LIALDA (mesalamine) Losartan potassium (COZZAR) Omeprazole (PRILOCEC) Simvastatin (ZOCOR) XANAX (Alprazolam) Ammonium Lactate cream Aspirin Diphenh,,Prostate cancer Ulcerative colitis Dilated cardiomyopathy,"Reactions to various vaccines: flu, shingles, at various times, fever, soreness, mild flu symptoms.",Compazine Altace,"['Erythema', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,IM 1046115,MI,43.0,F,Patient started to have red bumpy rash on neck and face approximately 10 minutes after receiving vaccine. Patient received injectable Benadryl 50mg in left deltoid at 10:10am. Approximately at 10:32am patient stated to nurse she is having difficulty swallowing. RN then administered 3mg of Epinephrine in the right thigh at 10:36am. Patient refused EMS and had her sister-in-law who was with her drive her to hospital. RN called Pt at approximately 3:15pm for follow up. Patient stated to RN that she is well and was given Pepcid and observed at the emergency room for 4 hours than discharged home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,SCH,unknown,unknown,unknown,,unknown,"['Dysphagia', 'Rash', 'Rash erythematous', 'Swelling', 'Swelling face']",2,MODERNA,IM 1046116,IN,61.0,M,"Flu-like symptoms lasting about 36 hours (myalgias, arthralgias, malaise, low grade fever, and intermittent chills)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PVT,Levoxyl Omeprazole,none,none,Similar symptoms after shingles vax fall 2020,none,"['Arthralgia', 'Chills', 'Influenza like illness', 'Malaise', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1046117,OH,67.0,F,"5:20PM 'SOB, DIZZY, THROAT TIGHT'. PLACED ON COT WITH HEAD ELEVATED. CONTINUES TO HAVE SOB. 5:30PM STATES 'FEELING BETTER'. 5:40PM BECOMING SOB AGAIN. 5:55PM INCREASED SOB/DYSPNEA- SQUAD CALLED. IV ATTEMPT X3 WITHOUT SUCCESS. 6:30PM TRANSPORTED TO ER VIA SQUAD, A/O X3, PINK, W/D, SEVERE DYSPNEA. (2-19-21 3PM TC PT RELEASED FROM HOSPITAL THIS AM. FULL RECOVERY .)",Not Reported,,Yes,Yes,1.0,Not Reported,Y,02/18/2021,02/18/2021,0.0,PUB,,NONE,,ANALPHALACTIC TO FLU SHOT IN 1950,"IBUPROFEN, TORADOL, HEPARIN, CODIENE, BIAXIN, ASPRIN, MORPHINE, DILANTIN, VISTARIL, STADOL, AUGMENTIN, AMOXICILLIN","['Cardiac monitoring abnormal', 'Dizziness', 'Dyspnoea', 'Sinus tachycardia', 'Throat tightness']",1,PFIZER\BIONTECH,IM 1046118,,82.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046119,MI,61.0,F,"AFTER RECEIVING THE VACCINE, SHE STARTED HAVING DIFFICULTY BREATHING. ONSITE EMS/PHYSICIAN RESPONDED. VITALS ARE BELOW. EMS WANTED TO TRANSFER HER TO EMERGENCY ROOM BUT SHE REFUSED AND WENT HOME AGAINST MEDICAL ADVICE.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/20/2021,0.0,PUB,"VENTOLIN INHALER, QVAR INHALER",,,,PENICILLIN AND SOME NARCOTICS,['Dyspnoea'],1,MODERNA,IM 1046120,NV,42.0,M,"Broke out in blistered bumps on legs, lingered for a month",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/15/2021,2.0,PUB,,,,,,"['Blister', 'Peripheral swelling']",1,MODERNA,IM 1046121,KY,87.0,M,"fatigue, high heart rate, sob, low blood pressure, feels cold all the time, no appetitive, palpitations",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/23/2021,3.0,PUB,"toprolol, lipitor, flomax,",no,"past prostate cancer,",,penicillin,"['Cardiac monitoring', 'Decreased appetite', 'Dyspnoea', 'Electrocardiogram', 'Fatigue', 'Feeling cold', 'Heart rate increased', 'Hypotension', 'Palpitations']",1,MODERNA,IM 1046122,PA,64.0,F,"delayed cutaneous hypersensitivity reaction,5 x 7 inches, discomfort, mild itch and redness not bothering me",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/22/2021,5.0,PHM,"imitrex 100 mg once,Aleve taken once ,amytriptilline 10 mg once",none,"H/O CLL- indolent, chronic migraine, asthma",,sulfa,"['Dermatitis allergic', 'Discomfort', 'Erythema', 'Pruritus']",2,MODERNA,IM 1046123,CA,40.0,F,"Lymphoid under left day swollen and bruised. 2 inches under vaccine site was swollen, red and hot to touch. Now bruising down the arm to her elbow. Last Lymphoid behind her left knee was swollen and enlarged.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/19/2021,1.0,UNK,,,,,,"['Lymphadenopathy', 'Vaccination site bruising', 'Vaccination site erythema', 'Vaccination site swelling', 'Vaccination site warmth']",2,PFIZER\BIONTECH,SYR 1046124,NC,67.0,F,"no pain at injection stie; however very severe chills began 12 hours after vaccine, temperature 99.1, brutal joint pain (wrists, hips, knees, ankles, burning & stinging sensation in around nerves and muscles, mild nausea/headache, no sleep for 24 hours. symptoms improved after 48 hours; mild chills, joint/muscle/nerve pain (however, i had some of these symptoms from the chemotherapy and they are now back to that level) i tried to forego pain relievers, but i had to take 2 advil and 2 benadryl 16 hours after the vaccine (around midnight) and took 2 more of each about 12 hours later. drank lots of lemon water to stay rehydrated. normal appetite.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,SCH,"zyrtec, singulair, metopropol, hydrochlorothyzide, paxil, gabsapentin vit d3, calcium, b12, probiotics",,"triple negative breast cancer with andryiamicin x6 treatments, paclatoxol x 12, radiation x20 finished treatment december 2017",over 65 flu vaccine,"codeine sensitive, lactose intolerance","['Arthralgia', 'Burning sensation', 'Chills', 'Headache', 'Insomnia', 'Myalgia', 'Nausea', 'Neuralgia', 'Pain', 'Pyrexia']",2,MODERNA,SYR 1046125,NY,59.0,M,RASH APPEARED ON PATIENTS NECK AND TORSO. BENEDRYL 50MG PO ADMINISTERED.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,OTH,RASH PRESENTED ON PATIENTS NECK AND TORSO. BENEDRYL 50MG PO ADMINISTERED.,NONE REPORTED,NONE REPORTED,,NONE REPORTED,['Rash'],2,MODERNA,IM 1046126,,76.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046127,NY,80.0,M,"Patient was observed after 15 minutes of vaccination, appeared to be well. 5 minutes after observation person, patient was in the waiting room and stated he was feeling dizzy and lightheaded",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PVT,"Hydrochlorothiazide, isosorbide, atorvastatin, combigan, finasteride, losartan,",,"Hypertension, bph, high cholesterol",,none,['Dizziness'],,MODERNA,IM 1046128,FL,76.0,F,"Extreme ache, pain and stiffness in left arm, from elbow up into neck and shoulder area. This began on Day 8 after receiving vaccine and has continued through today - 10 days after vaccine 2 Arthritis Tylenol 650 mg",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,OTH,Pravastatin 40mg Amlodipine Medoxim 10-20 mg Ibandronate Sodium 150 mg Venlafaxine 37.5 mg D3 2000 IU CENTRUM SILVER 50+ PreserVision Areds 2 Aller-chlor 4 mg x2 Omeprazole capsule 20 mg,None,Arthritis High blood pressure controlled by RX High cholesterol controlled by RX,,Penicillin Codeine,"['Injection site pain', 'Injection site reaction', 'Musculoskeletal stiffness', 'Neck pain']",1,MODERNA, 1046129,OH,70.0,F,"Approx. 1 hr. & 20 min. post injection, severe reaction: Severe upper abdominal pains, multiple, uncontrollable formed to diarrheal bm's triggered vagal response, passed out, severe diaphoresis, violent chilling loss of control of bowel movements. Lasted approx. 30-35 minutes. crawled with head hanging to floor to keep from passing out, to locate a phone for help. after several of agonizing attempts to try and climb up to couch to elevate legs high above head and laying there for approx. 20 or more min. blood pressure came up some. (Did not call emergency services) afraid of hospitalization due to all chronic health problems, (forgot to report earlier that I am Hypothyroid as well) previously hospitalized for a Thyroid Storm. This is day 10 from injection and still have nausea, dizziness & fatigue, (also have couple episodes of abdominal pain). (I want to add that I felt completely fine prior to receiving 2nd Pfizer Covid dose). I am contacting my doctor today to receive some IV fluids.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,PUB,"pyridostigmine, folic acid, pantoprazole, misoprosotol, sodium chloride, biotin, hydroxychloroquine, famotidine (HS), metoprolol",none,"Primary Immune Deficiency, Myasthenia Gravis, Sjogren's, Autonomic Neuropathy, Myelodysplastic Syndrome, Von Willenbrand's",,"not allergies but hypersensitive to : latex, ct scan dye, ddavp, fentanyl, levaquin, codeine","['Abdominal pain upper', 'Anal incontinence', 'Blood pressure decreased', 'Dizziness', 'Fatigue', 'Gait inability', 'Hyperhidrosis', 'Loss of consciousness', 'Nausea', 'Presyncope']",2,PFIZER\BIONTECH,IM 1046130,WI,33.0,F,"Received first dose on 1/8/21 and second dose on 2/5/21. Mild side effects after first dose (soreness in arm). During 1st 24 hours of having the 2nd dose I had chills, fever, body aches, sleeplessness. Symptoms subsided within 24-48 hours with the arm soreness taking about a week to completely go away. A week and a half after receiving the 2nd dose I noticed a lump on my neck, lower middle near the collarbone. It is significantly pronounced. I saw my primary doctor for an already scheduled physical and she said I was fighting off an infection and it was normal. I mentioned I had the COVID vaccine and she said it isn't uncommon to see the lymph node swell after vaccination and it should go away in a couple of weeks. I wanted to report this because it can freak people out to see a lump in their neck so long after being vaccinated without any other symptoms. We need to list this as a possible side effect on the vaccine information. I feel completely fine except my neck is a little tender/sore from the swollen lymph node.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/17/2021,12.0,WRK,Doxycycline monohydrate 100 MG capsule 2x daily Sulfacetamide sodium/sulfur 10-5% cream 2x daily,None,Acne,,None,"['Chills', 'Insomnia', 'Lymph node pain', 'Lymphadenopathy', 'Pain', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 1046131,CO,39.0,F,"24 Hour Reaction included headache, dizziness, drowsiness 7 days post injection - large circular(ish) rash/hive/raised welt around the injection site. Itched. Anti-itch cream helped. This spot is still residual but is almost gone now. Unknown but estimated started at 5 days post injection, pain/discomfort/swelling in lymph nodes around breasts, especially left side. This discomfort continued 10 plus days after it appeared.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/10/2021,7.0,UNK,"Xanax, Zoloft, Zyrtec, Clonidine, Asmanex, Ventolin, Pepcid AC, Vit D3, Multi-Vitamin, Probiotic",None,"Asthma, Allergies: Seasonal (trees/grass/weeds), Animals (cats/dogs/etc.), Tree Nut (severe), Avocado (sensitive), Dermographism",,"Penicillin, Tree Nuts, Animals/Nature in general","['Breast discomfort', 'Dizziness', 'Headache', 'Injection site pruritus', 'Injection site rash', 'Injection site reaction', 'Injection site urticaria', 'Lymph node pain', 'Lymphadenopathy', 'Skin reaction', 'Somnolence', 'Urticaria']",1,MODERNA,SYR 1046133,IA,26.0,F,"Fatigue, headache, body aches and chills, fever, nausea and vomiting, blurred vision, loss of appetite.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PHM,,,,"chills and body aches, fever, headache, 26, 01/2021, Moderna COVID vaccine dose 1",,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Vision blurred', 'Vomiting']",2,MODERNA, 1046134,,76.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046135,NY,70.0,F,"On Day 8, my arm developed a rash, first small about 1 "" around then the swelling and rash became large all the way to the bra strap line and all the way to the elbow and about 2 inches under the arm. My entire body also became itchy, area on the neck as the same side as the left arm where I had the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/14/2021,8.0,OTH,NONE,NONE,NONE,Shingles Vaccine - developed cellulitis - two years ago,Allergic to IV contrast and Bactrim,"['Peripheral swelling', 'Pruritus', 'Rash']",1,MODERNA,IM 1046136,,81.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046137,NC,65.0,F,"Seven days after receiving the Moderna vaccine my arm started itching, became swollen and a bright red rash appeared at the injection site. The size of the rash was approximately 6 x 4 inches. The itching subsided in approximately 48 hours but it was 9 days before the swelling and the rash finally improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/11/2021,7.0,OTH,None,None,None,,Coedine,"['Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Rash erythematous']",1,MODERNA,IM 1046138,,76.0,F,"During monitoring period post Pfizer COVID-19 vaccine, pt states she has mild tongue swelling and tongue numbness. VS: 123/72, Given Benadryl 25mg by mouth. Patient was transferred to: home",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/18/2021,0.0,PVT,,,,,,"['Hypoaesthesia oral', 'Swollen tongue']",2,PFIZER\BIONTECH,IM 1046139,PA,69.0,F,"Moderna COVID-19 Vaccine. About 15 hours after I received the second injection I experienced severe chills, with chattering teeth, while trying to go to sleep. This lasted for several hours. By the morning the chills were gone. My husband, who received the same vaccine at the same time had the same reaction--severe chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PVT,"Simvastatin, Citrucel, Vitamins C & D, Ocuvite, 81 mg Aspirin",,"Osteoporosis, Cholesterol","Yellow Fever vaccine, @53 yrs, large red swollen injection site","Levaquin, Penicillin, Sulfa",['Chills'],2,MODERNA,IM 1046140,NY,92.0,M,Rash at site of vaccine on day 5 Extreme fatigue and weakness on day 6 and 7,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/14/2021,02/19/2021,5.0,PVT,"Levothyroxin, Creon (pancrelipase), Omeprazole, Vitamin B-12, A-Reds eye vitamin, Carafate, Iron infusions",None,Pancreatic enzyme deficiency. Low Iron/low red blood cell,,Stomach bleeding with NSAIDS Severe headaches with Demerol,"['Asthenia', 'Fatigue', 'Vaccination site rash']",2,MODERNA,IM 1046141,MI,30.0,F,Had itchyness on skin around neck/throat area,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PUB,,,,,NKA,['Pruritus'],2,MODERNA,IM 1046142,,80.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Product preparation issue'],2,PFIZER\BIONTECH,IM 1046144,IA,45.0,F,"Slight fever (99.3-99.5 degrees); headache, nausea/gagging, whole body aches/ very fatigued for approximately 24-36 hours. Took ibuprofen, and slept it off.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PHM,"Paroxetine, Metformin, Amlodipine, Tylenol PM",None,"PCOS, High Blood Pressure, anxiety/ depression",,"Penicillin, Sulfa, Kiwi","['Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Retching']",2,MODERNA,SYR 1046145,NJ,68.0,M,"Headache, 102 fever, diarrhea, nausea, dizziness, body aches for 17 days. Then continued sluggishness for another 7 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/27/2021,3.0,SEN,Nothing,Nothing perfect health,Nothing perfect health,,None,"['Diarrhoea', 'Dizziness', 'Headache', 'Influenza virus test negative', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH, 1046146,IL,73.0,F,"Itchiness at injection site immediately after injection on 2/9/2021. Large -2-3 inch- raised, red, hard, area at injection site 2/22/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/09/2021,02/22/2021,13.0,OTH,Losartan/hctz 100/12.5 amlopidine 5mg carvedilol 12.5 mg,none,hypertension,"October, 2000, Flu vaccine, brand unknown, itching, swelling at site","aspirin, advil, tetracycline, soy, latex, nickel","['Immediate post-injection reaction', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 1046147,,76.0,M,Patient had itching after the 2nd dose Pfizer vaccine was given. Given diphenhydramine 25 mg PO. Patient had reported hives after first dose.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,PVT,,,,,,"['Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,IM 1046148,OH,80.0,F,approx 1am I woke up and I was shivering so hard the bed was shaking and I could not get up out of bed safely. I have never experienced a chill like this before. 3-4am I was shivering and shaking and so very cold again. this lasted until at least 4-5pm. I was shaky and my voice was shaky. no appetite.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PVT,alopurinol amlodipine bisulfate lisinopril spirolactin Vitamin E Vitamin D,No,Untreated Hep-C High Blood Pressure,,Sulfa Meds Insect Bites Latex,"['Chills', 'Decreased appetite', 'Dysphonia', 'Feeling cold', 'Mobility decreased', 'Tremor']",2,MODERNA,SYR 1046149,CA,70.0,F,Red inflamed rash at site of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/21/2021,9.0,PHM,Progesterone 100mg Cap Estradiol 0.5mg Tab Restasis 0.05% Opth. Centrum Silver Multivitamin Ester C Vitamin Glucosamine - Chondroitin Tablets Probiotic 10,None,None,,Latex - Contact Dermatitis Sulfa Drugs Skin very sensitive to topical products,"['Injection site inflammation', 'Injection site rash', 'Rash erythematous']",1,MODERNA,IM 1046152,CO,66.0,F,"On day 2 after vaccine (Sunday), woke up with very stiff lower back--I never have lower back issues and did nothing to provoke it. Was very stiff the whole day (took Naproxen Sodium AM and again that night.) Much improved when waking up on Monday.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/21/2021,2.0,PHM,Losarstan 10 mg Zolpidem 5 mg Maganesium time release Vitamin D 6000IU per week,none,mild hypertension,,none,['Musculoskeletal stiffness'],2,MODERNA,IM 1046153,IL,63.0,F,"Experienced Double Vision about 30 minutes after injection. Cleared within 20 minutes. After 36 hours: injection site tenderness, swelling, (no redness)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PUB,None,None,None,pain/swelling after DPT,"Penicillin; Erythromycin; Ginger Sensitivity to Latex, Green Bell Peppers, Cardamon, Cucumbers","['Diplopia', 'Injection site pain', 'Injection site swelling']",UNK,PFIZER\BIONTECH, 1046154,,70.0,F,Patient reported lip tingling at observation station. Given a dose of diphenhydramine 25 mg PO and instructed to take another dose in 4-6 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/20/2021,0.0,PVT,,,,,,['Paraesthesia oral'],1,PFIZER\BIONTECH,IM 1046155,LA,79.0,M,"Patient became dizzy 15 minutes after vaccination. Emergency services was called. Patient went into a sleep state for about 15 seconds but with stimulation was responsive and was able to speak to me immediately. Patient then became nauseated and approximately 10 minutes from start of event vomited. After this the patient began to feel better. Paramedics arrived and evaluated patient. Blood pressure, pulse, oxygen level, glucose level were all normal. Patient was convinced to go to Emergency Room with paramedics to be evaluated.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PHM,,Wife mentioned sees Cardiologist. No other information available.,None per questionnaire.,,Penicillin,"['Altered state of consciousness', 'Blood glucose normal', 'Dizziness', 'Nausea', 'Vomiting']",2,MODERNA,IM 1046156,,82.0,M,"Patient was asymptomatic to COVID and presented to the hospital for other health conditions. While in the hospital, patient was tested for COVID (standard protocol) left nasal swab via SARS-CoV-2 Test (T2 Biosystem/ T2SARS-CoV-2 Panel) and the result came back positive. This is on 2/8, roughly 2 weeks after first dose of Pfizer vaccination. Per physician, ""Patient was COVID positive, but asymptomatic, no leucocytosis, no fever, CXR showed no signs of PNA, and pt SaO2 above 95% on RA"". Patient was continue to be monitored and isolated. Patient was discharged once stable for his admitting condition other than COVID",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,02/08/2021,13.0,PVT,,,,,"Codeine, Shellfish","['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1046157,AZ,61.0,F,"developed a skin rash on the same arm where vaccinated, nine days after the shot. It is red, firm and itchy. Then blisters",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,02/19/2021,9.0,PVT,"acyclovir 400 mg tabs, 1 tab tid x 5 days as needed for flare ups",Hyperlipidemia E78.5 Osteopenia M85.88 Herpes simplex infection,as above,,Levaquin stomach cramping and hallucinations PCN rash,"['Blister', 'Induration', 'Rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 1046158,MI,63.0,M,"Patient experienced Chest pain & was diaphoretic approx 5 minutes after vaccination. Onsite EMS was called vitals BP 168/107 HR 63 100% O2 room air. No past reaction to vaccine, last flu vaccine in September. Patient said he was feeling better after approx 10 minutes. Relased to home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PUB,Lisinopril,,HTN,,Lisinopril,"['Chest pain', 'Hyperhidrosis']",1,MODERNA,IM 1046159,TX,16.0,F,PATIENT HAD NO ADVERSE EVENT. THIS REPORT IS BECAUSE THE PATIENT IS BELOW THE RECOMMENDED AGE. THE PATIENT'S PHYSICIAN AUTHORIZED THE IMMUNIZATION,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PHM,,,LUNG TRANSPLANT PATIENT,,,"['Intentional product use issue', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 1046160,PA,67.0,F,About 10 days after the vaccine there was itching at the vaccine site. 12 days later there was a rash approximately 4 inches in diameter. I am hoping it goes away on it's own.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,02/20/2021,10.0,PUB,"multi vitamin, baby aspirin, calcium w/D, B complex, Farxiga, Trulicity, Metformin, glimiperide, omeprazole",,"diabetes, arthritis",,milk,['Rash'],UNK,MODERNA,IM 1046161,,49.0,F,"Heart racing, feeling hot, feeling like world is closing in. 10:49 improved and discharged home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,UNK,,,,,,"['Disorientation', 'Feeling hot', 'Palpitations']",2,MODERNA,IM 1046162,AZ,71.0,F,"Eight days after the first vaccination, the injection site became inflamed, reddened, and itchy in an approximate 3-inch area. I Will continue to observe.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PHM,Lisinopril 2.5 mg; Daily NP Thyroid 90 mg Daily,None,None,,Phenylpropanolamine,"['Injection site erythema', 'Injection site inflammation', 'Injection site pruritus']",1,MODERNA,IM 1046163,GA,54.0,F,"Itching at injection site and sporadic itching in multiple areas of body. Itching, very dry skin centralized on face starting Friday, February 19 around 5 PM. It continues. Benadryl 25 mg taken by mouth.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/10/2021,0.0,PVT,Multi-Vitamins,None,Crohn's Disease,Flu Vaccine 2019,"Seasonal, grass","['Dry skin', 'Injection site pruritus', 'Pruritus']",2,PFIZER\BIONTECH,IM 1046164,,75.0,F,Patient self-reported left arm pain traveling down her arm after second dose of covid vaccine (pfizer) administration. Patient has documented history of anaphylaxis with IV contrast. EMS on-site provided cardiac monitoring. Observed elevated BP.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/20/2021,0.0,PVT,,,,,,"['Blood pressure increased', 'Cardiac monitoring', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 1046165,OH,44.0,F,Shingles developed on the right upper back 3 weeks after the rash,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/22/2021,20.0,WRK,"Losartan, Lexapro, Klonopin",none,"Hypertension, insomnia, panic, hip pain",,Reglan,"['Herpes zoster', 'Rash']",UNK,PFIZER\BIONTECH, 1046166,NY,75.0,F,"Yesterday 2/21/21 started having itching on her arm, round area when she looked in the mirror at the time of her vaccine. Area is warm, very itchy and 1 1/2"" x 1 1/2"" in size. The area is also red today, intensely itchy. Did put cortisone cream on it yesterday, which didn't make it go away, possibly reduced the itching some, but not much. She does also have a headache today. She takes a lot of vitamins, and has not taken anything else for the reactions.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/21/2021,9.0,PHM,"Women's multivitamin, Elizine, Chromium, vitamin D3, Selenium, Vitamin C, Zinc, Vitamin A, Biotin, CoQ10, Super B complex, calcium, Magnesium, Lycopene, Resveratrol, Ginseng, chlorella, B1, Elglutamine, black current seed oil, milk thistle",None.,"Allergies, nasal congestion, chronic rhinitis.",,"Cipro, Levaquin (rapid heart beat), anaphylaxis to antihistamines. Vancomycin (passed out during surgery and discontinued), Keflex (doesn't know the reaction was in surgery and almost died from a ruptured uterus, told not to take it).","['Erythema', 'Headache', 'Pruritus', 'Skin warm']",1,MODERNA,IM 1046167,PA,32.0,F,"12 hours later symptoms of- diarrhea, severe vomiting, chills, body aches, fatigue, light/touch/sound sensitivity, dizziness 24 hours later symptoms continued except for diarrhea and vomiting. New symptoms of heart palpitations, dizziness, difficulty taking deep breaths, continued sxs of light/sound sensitivity, body aches, fatigue, night sweats 48 hours later- most symptoms better but continued fatigue, difficulty taking deep breaths, heart palpitations, night sweats",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,"Escitalopram 10mg daily, Spironolactone 100mg daily","none,",none,,NKDA,"['Chills', 'Diarrhoea', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Hyperacusis', 'Hyperaesthesia', 'Night sweats', 'Pain', 'Palpitations', 'Photophobia', 'Vomiting']",2,MODERNA,IM 1046168,,86.0,F,Fever 101.5. Chills body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/22/2021,2.0,PVT,Levothroid. Losarten amlopidine plavix,,Asthma high blood pressure,,Penicillin,"['Chills', 'Pain', 'Pyrexia']",UNK,MODERNA, 1046169,,72.0,F,Pt. reports she developed aches and pain- low back and knee. Chills and an abdominal pain that started yesterday that lasted until she went to bed last night at 10 pm/,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,UNK,"Anastrozole, B12, calcium, hydrochlorothiazide, rosuvastatin",,"History of breast cancer, hyperlipidemia, osteopenia, Meniere's disease",,,"['Abdominal pain', 'Arthralgia', 'Back pain', 'Chills']",2,MODERNA,IM 1046170,NC,79.0,M,Right arm and leg noted with continuous uncontrollable jerking movements of involuntary nature that are still persisting.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/03/2021,1.0,SEN,Novolog Flex pen 100/ml 8 units with meals Levothyroxine Sodium Tab 125 mcg 1x day Cochicine caps 0.6 mg 1x day Thiamine HLC tab 100mg 1x day Folic Acid tab 1mg 1x day Med plus 1.7nsa 4 oz. 2x day Levemir flex touch 110u/ml 16 untis 2x day,None,History of: Type 2 DM Protein Calorie Malnutrition Dementia Dysphagia Polyarthritis Respiratory-pneumonioa Hypothyroidism PVD Vit B deficency Alcohol abuse Major Depressive Disorder HTN osteoarthritis GERD,,Hydroclorothiazide,"['Blood test', 'Dyskinesia', 'Neurological examination', 'Urine analysis']",2,MODERNA,IM 1046171,NY,56.0,F,"PATIENT REPORTED SHORTNESS OF BREATH, CHEST PRESSURE, DIZZINESS. PATIENT REPORTED AS THOUGH ""SHE WAS GOING TO PASS OUT"". REPORTS FULLNESS IN THE THROAT AND A THICK TONGUE. EPI ADMINISTERED RIGHT THIGH, BENEDRYL 50 MG ADMINISTERED IM RIGHT DELTOID. 911 CALLED, PATIENT ""JITTERY"", BREATHING IRREGULAR AND GASPY.. EMS TRANSPORTED PATIENT TO HOSPITAL.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/12/2021,0.0,OTH,UNKNOWN,NONE REPORTED,NONE REPORTED,"FLU VACCINE, AGE UNKNOWN, HIVES",HIVES TO FLU VACCINE AND CERTAIN STEROIDS. UNABLE TO REPORT SPECIFIC TYPES.,"['Chest discomfort', 'Dizziness', 'Dyspnoea', 'Feeling jittery', 'Irregular breathing', 'Oropharyngeal discomfort', 'Tongue disorder']",2,MODERNA,IM 1046172,MI,63.0,F,"The following day plus 2 more days (3total) I had severe muscle pain in my left lower back/hip area, only when I would sit or lay down. It was very faint if I would walk around. The next 4 days I only had the muscle pain morning and evening, and very faint. Not at all throughout the day.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/13/2021,1.0,OTH,Vitamin c and d. Glucosamine joint rebuild. (Supplements),None,None,,"Bee, wasp venom.",['Myalgia'],1,MODERNA,SYR 1046173,CO,61.0,F,"Sharp arm pain down arm of shot. Within 20 minutes of shot experienced moderately severe vertigo and dizziness, along with difficulty breathing normally.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/20/2021,19.0,PVT,"Magnesium, zyrtec",None,"Breast cancer survivor, asthma",,None,"['Dizziness', 'Dyspnoea', 'Pain in extremity', 'Vertigo']",UNK,PFIZER\BIONTECH, 1046174,AZ,59.0,F,"I went to get my second Covid - 19 Pfizer- BioNTech vaccine Saturday night 2/20/21 at 7:30 pm. The nurse wiped my right arm with alcohol, threw out the wrapper, and then got the vaccine. I was in the passenger side so she needed to open the door. I felt the needle go in my arm, but a line of liquid went down my arm to my wrist as she gave the shot. I asked if that was supposed to happen and the nurse said ""it was the alcohol"". I was concerned since the alcohol had already been wiped on my arm and I would have felt that when she wiped it. I am concerned because the liquid came out when the shot was given. I am now worried that I didn't get the vaccine. My arm is red where the injection was but I have no side effects. I need to report this since it did not seem right and I don't know if the vaccine was given to me fully.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,OTH,None,None,None,,None,"['Exposure via skin contact', 'Injection site erythema', 'Syringe issue', 'Underdose']",2,PFIZER\BIONTECH, 1046175,KY,34.0,F,"Excruciating pain that radiates down left arm and makes arm completely numb. Patient went to local clinic the day after her shot and her doctor told her the shot was most likely gave too high on the arm, could possibly be SIRVA.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,PUB,On 2/20/21 patient started taking prednisone and Toradol.,,,,,"['Hypoaesthesia', 'Pain', 'Pain in extremity', 'Product administered at inappropriate site']",2,MODERNA,IM 1046176,,80.0,M,"Went to Dr office and was found to have bradycardia, hypoxia, and resp distress. Sent to ED and was found to have complete heart block, uncontrolled hypertension, worsening resp distress. Adm to ICU for plans for permanent pacemaker placemen, now placed. Patient received COVID vaccine 2 days prior. Specific vaccine information unknown since administered outside of facility.",Not Reported,,Not Reported,Yes,15.0,Not Reported,Y,02/02/2021,02/04/2021,2.0,UNK,,,,,,"['Atrioventricular block complete', 'Bradycardia', 'Cardiac pacemaker insertion', 'Hypertension', 'Hypoxia', 'Intensive care', 'Respiratory distress']",UNK,MODERNA, 1046177,IN,76.0,F,"Sore injection site first two days (slight difficulty laying on that side), then Day 9 developed a rash and itching close to injection site, Day 11 noticed swelling on the upper arm and tenderness in armpit; Day 13 rash about doubled in size and some itching returned Applied Cortizone-10 to relieve itching - it helped",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/17/2021,9.0,PUB,"amlodipine besylate, 5 mg; Atorvastatin, 10 mg; Vesicare 5mg; Benadryl 1 day; aspirin 81 - 1 day; famotidine 40mg; latanoprost opth sol 2.5ml 0.005%, 1 drop day; AREDS 2, 2 day; Move Free Ultra - Type II Collagen+Boron+HA - 1 day;",none,"reflux, high blood pressure, arthritis, incontinence, glaucoma",,none known,"['Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Peripheral swelling', 'Tenderness']",1,MODERNA,IM 1046178,WI,70.0,F,"Woke up about 1 a.m. and was scratching my wrist. I got up and turned on the light. My hands were sort of a splotchy red (more red than not...) and itched, especially the wrist of my left hand. My fingers were a bit puffy, but not swollen. I ran my hands under cold water and used a hand cream. They still itched a bit, but were better. I waited a bit and reapplied hand cream. I was tired and fell back asleep about 1:30 a.m. When I woke up about 7 a.m., my hands were fine and there was no itching. I have been fine since (altho I experienced the tiredness others have mentioned).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PHM,lisinopril; omeprazole; fish oil; florigen; vitamin d,none,sleep apnea; overweight,,morphine based products; bee stings,"['Fatigue', 'Pruritus', 'Rash macular', 'Skin swelling']",2,MODERNA,IM 1046179,OH,48.0,F,patient was not vaccinated at hospital. Caregiver reports that patient was vaccinated with second dose on Monday 2/15/21. Tuesday patient experienced n/v/d. Went to an ED on Wednesday and was cleared and sent home. Thursday reported shortness of breath to her caregiver and then collapsed. Patient was brought to as PEA arrest and ultimately died.,Yes,02/18/2021,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/16/2021,1.0,PVT,unknown,unknown,MRDD,,NKMA,"['Death', 'Diarrhoea', 'Dyspnoea', 'Nausea', 'Pulseless electrical activity', 'Syncope', 'Vomiting']",2,PFIZER\BIONTECH,IM 1046180,MN,29.0,F,"Vaccine recipient woke up 2/17/21 at approximately 7 AM with itchy skin and small hives. Around 8 AM she had difficulty breathing, and when she went in to be seen at her clinic she had difficulty swallowing. At this time, an ambulance was called and she was transported to the ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/14/2021,02/17/2021,3.0,SEN,"Methotrexate, Humira, diclofenac, Fenofibrate, folic acid",,Psoriatic arthritis,,,"['Dysphagia', 'Dyspnoea', 'Pruritus', 'Urticaria']",1,MODERNA, 1046181,NC,77.0,F,"Red, itchy spots around the injection site but not the circle shape as in Covid arm. Mostly it is just a rash about the size of a golf ball or a bit larger. It showed up about 8-9 days after injection. I have been putting cortisone 10 cream on it for the itching and it helps some but not completely.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/21/2021,9.0,PVT,Lisinipril Xanax Low Dose Aspirin acetamenaphin 500mg,None,High blood pressure,,Benedryl codiene Pennicillin,"['Injection site rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,SYR 1046182,VT,27.0,F,"Left arm soreness onset 2 hours post injection. Chills and fatigue onset 3 hours post injection. Fever 4 hours post injection. 24 hours post injection still feeling fatigue, sore arm, and chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,PHM,"Desvenlafaxine, buspar, wellbutrin, Vit D and Vit B complex, probiotic",,Anxiety,,"Sulfa, opiates, compazine, shellfish, agave","['Chills', 'Fatigue', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 1046183,FL,78.0,F,"I couldn't sleep the night of my shot. I felt like l had the flu. No fever but just so sick and because of the myesthenia my breathing was compromised. On the oxymeter it showed 92 and 93 at times. Today, the 22nd February l feel better but weak and tired and my head feels funny Hard to describe. I still feel it's difficult to take a deep breath",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PHM,"I have myesthenia gravis and take pyrogestamine and mycophenalate. Also losarton, synthroid, cymbalta, crestor, vitamin b3, and 80mg",Sinus infection took doxycycline for 2 weeks.,"Myesthenia gravis, high blood pressure",,Codeine,"['Asthenia', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Sleep disorder']",2,MODERNA,SYR 1046184,FL,27.0,F,"8 days post completion of the COVID-19 Pfizer 2 vaccine series, herpes zoster (shingles) outbreak began on the left forehead with ocular migraine and hypersensitivity of the left medial portion of the face. Valacyclovir 1000mg TID x10 days was initiated within 24 hours of onset, and rash continued to progress down the face to the left eyebrow, left nostril, and left upper lip. Pain and hypersensitivity of the left upper jaw and teeth began on day 3 of zoster outbreak, and ocular migraine increased in intensity. The rash began to blister on day 4, and is continuing to blister and weep currently (day 5).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/17/2021,8.0,PVT,Multivitamin,,,,NKDA,"['Herpes zoster', 'Hypersensitivity', 'Migraine with aura', 'Pain in jaw', 'Physical examination abnormal', 'Rash', 'Rash vesicular', 'Skin weeping', 'Toothache']",2,PFIZER\BIONTECH,IM 1046185,ID,42.0,F,"Itching in arm and torso immediately after injection-took standard dose of Benadryl 24 hours after injection, headache and some fatigue-took Ibuprofen 36 hours after injection, migraine, arm pain, fatigue, nausea-took flexiril, Zofran, and Ibuprofen 48 hours after injection, fever of 101, armpit pain, arm pain, fatigue-took Ibuprofen 72 hours after injection arm swollen in 3""x5"" oval, bright red, hot to touch, armpit very tender, mild headache-took Ibuprofen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,PVT,"Fluoxetine, LD Naltrexone, Estradiol-all daily Ativan, Adderall, Xyzal, Flexiril, Pantoprazine, Famitidine-as needed",,Ulcerative Colitis,,"Cillins, Ceclor, Sulphas, 5-Amino Salicylicates, Gluten sensitive","['Axillary pain', 'Fatigue', 'Headache', 'Immediate post-injection reaction', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Migraine', 'Nausea', 'Pain in extremity', 'Pruritus', 'Pyrexia', 'Tenderness']",2,PFIZER\BIONTECH,IM 1046186,CA,54.0,F,"Approximately 15 minutes post-vaccination (0830), pt started feeling dizzy, nauseous and had one episode of emesis. Vital signs at 0830 were bp:184/108, p:112, SpO2:99%. At this time pt was flushed, skin was hot and dry. Vitals at 0835 were bp:179/124, p: 92. Pt began feeling chest pain. Vitals at 0840 were bp: 182-108, p:86. Emergency services were called and pt was transferred to local ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,MIL,Lisinopril,,Breast Cancer High Blood Pressure,,Morphine oxyCODONE,"['Chest pain', 'Dizziness', 'Dry skin', 'Flushing', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 1046187,IL,,U,FEVER AND PAIN AT INJECTION SITE,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,OTH,,,,,,"['Injection site pain', 'Pyrexia']",1,MODERNA,IM 1046188,OH,65.0,F,Pt states she awoke during the night and was very confused. Pt became incontinent and had unsteady gait. Pt was taken back to bed by husband. Duration of event took about 15-30 minutes. Pt states she has never had these symptoms in the past and has not experienced these symptoms since the event.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/12/2021,1.0,PVT,"Celebrex, Calcium, amlodipine, Tramadol, simvastatin, duloxetine, gabapentin, flexeril",,"Fibromyalgia, Hypertension",,Codein,"['Confusional state', 'Gait disturbance', 'Incontinence']",1,MODERNA,IM 1046189,OR,31.0,F,"Chest pressure and tightness, considered to possibly be costochondritis.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/18/2021,2.0,UNK,"Escitalopram, Buspirone, Zyrtec, vitamin D, Portia bcp (levonorgestrel)",Chronic sinusitis,Sinusitis,,"Cinnamon, mango","['Chest discomfort', 'Electrocardiogram normal']",2,MODERNA,SYR 1046190,PA,63.0,F,"Day 4 -Itching torso Day 6-contained raised itchy rash on right side of torso Day 8-vaccine site itchy right arm Day10-scattered raised rash on back, rash on left side, vaccination site pink Otherwise feeling fine. Extra tired at times.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/16/2021,4.0,PUB,Vit D3 B12 Multivitamin/Centrum for Women,None,Pulmonary Sarcoidosis,,AMOXICILLIN,"['Fatigue', 'Injection site erythema', 'Injection site pruritus', 'Pruritus', 'Rash', 'Rash papular', 'Rash pruritic']",1,MODERNA,IM 1046191,NY,43.0,F,"Day of injection 2/17: Sore arm, hard to lift with right arm Feverish but no fever Fatigue Loss of appetite Day of 2/18: Felt better but still fatigued Loss of appetite Day of 2/19: Moderate-severe diarrhea Day of 2/20: moderate to severe diarrhea Treated with an anti-diarrhea pill Day of 2/21: fatigued and weakness (assuming from diarrhea) Day of 2/22: weakness and keeping hydrated Consulting primary care physician on next steps",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/07/2021,02/19/2021,12.0,PUB,Metoprolol 100mg Buspar 7.5 mg Setraline 50mg Diazepam 0.5 mg Ozempric shot for weight loss (once a week),None,Hypertension Depression Anxiety Gallbladder - removed in 2007 Kidney stones,,None,"['Asthenia', 'Decreased appetite', 'Diarrhoea', 'Fatigue', 'Joint range of motion decreased', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA,SYR 1046192,WI,42.0,F,7 days after injection I have a red raised (at times itchy) rash at the injection site. I also have tenderness and irritation in my under arm and armpit. But I don't have a rash in those areas. I am filling this out as of 2/22/21 and I still have the red raised rash and tenderness in my under arm and armpit.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/18/2021,7.0,SEN,"10 mg Citalopram; Sucralfate 1GM, Omeprazole",None,Hashimoto's Thyroiditis.,,Amoxicillin,"['Injection site irritation', 'Injection site pain', 'Injection site rash', 'Injection site swelling', 'Rash erythematous']",1,MODERNA,IM 1046193,,77.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046194,LA,56.0,U,"I got the second Pfizer Covid Vaccine shot at around 3:00pm Feb17; early Feb18 morning, starting at around 2:00am, experiencing severe whole body muscle pains and ,joint pains, stomach ache(uncomfortable,feeling frequent need to use restroom, a little bit like diarrhea, but definitely not diarrhea);then from around 6:00am, starting feeling headache with high fever(about 100~101F). All those symptoms persisted for about 36 hrs, till the next day, Feb19, late in the afternoon, I started feeling much better with all those symptoms seemed gone, and the temperature dropped to about 97.5 F after taking 2 pills of NyQuill. Up till now(Feb22), I am still feeling good.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/18/2010,,UNK,"Synthroid, 50 microgram daily",Hypothyroid,Hypothyroid,,,"['Abdominal discomfort', 'Abdominal pain upper', 'Arthralgia', 'Frequent bowel movements', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1046195,MD,69.0,F,Left arm became inflamed at site of injection one week after the first dose. This is a very mild reaction. My arm is simply red around the the site and a little itchy. Just trying to add to the data on reactions to the Moderna vaccine. I am fine!,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,PHM,Vitamin D; Lutein,none,none,,none,"['Injection site erythema', 'Injection site inflammation', 'Injection site pruritus']",1,MODERNA,SYR 1046197,OK,49.0,M,Vaccine administration error. The patient received 0.5 mL of Pfizer vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,PVT,,None,Asthma,,NKA,"['Incorrect dose administered', 'Product administration error']",1,PFIZER\BIONTECH,IM 1046198,MO,60.0,F,"Woke up on 2/21 with a Migraine; then by 2:00 pm had nausea, chills, fever, tiredness. Did not feel good rest of day; did not sleep well and headache again this morning, 2/22/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/21/2021,1.0,UNK,L-Thyroxine Tabs 112 mcg - taken once a day - first thing in the morning Acyclovir Tabs 400 mg - taken once a day - morning Tolterodine Tart ER Caps - 2 mg - taken once a day - morning Estradiol/Norethindrone Acetate - 0.5 mg/0.1 mg - once,"A migraine 2/8. I also gave blood on Thursday, 2/18 before I knew I would be getting a vaccine on 2/20.",None,,Sulfa drugs,"['Chills', 'Condition aggravated', 'Fatigue', 'Headache', 'Malaise', 'Migraine', 'Nausea', 'Poor quality sleep', 'Pyrexia']",1,MODERNA,IM 1046199,,68.0,F,"Area of redness/swelling about 4x3 inches (oval shape), warm to touch, itchy, tender that lasted from 2/6-2/19, resolving with ibuprofen, hydrocortisone cream, cool/ice compresses Saw pt by televisit and looks like injection might have been given too low and was likely SC instead of IM",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/06/2021,0.0,PUB,,,,,Clindamycin - throat swelling,"['Incorrect route of product administration', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Product administered at inappropriate site']",1,MODERNA,IM 1046200,NC,24.0,F,"headache, fever, chills, nausea, body aches, sore arm, muscle spasms- hands and arms contracting (hands in fists and arms to chest like you see in individuals with CP) unable to move for 10+ minutes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,WRK,"loratadine, singulair, pantoprazol, vitamin D, sertraline",no,asthma,,no,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Paralysis', 'Pyrexia']",2,MODERNA,IM 1046201,,88.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046202,TX,35.0,M,"chills, muscule pains, night sweats, Headache,foogy mind set, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/04/2021,1.0,PVT,UNK,UNK,UNK,,UNK,"['Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Myalgia', 'Night sweats']",2,MODERNA,IM 1046203,,56.0,F,"Pt had a reaction to PFIZER vaccine felt flush and dizzy and fast heart rate, Emergency room was called to transport pt to ED and pt was given a epi pen in observation area where pt received epi pen, pt vitals were BP Right arm: 135/81 HR:117 O2 SAT: 100% on RA 9:18AM 56 y.o. female with a past medical history of hypothyroidism, GERD, anxiety, and Hashimoto's thyroiditis (on levothyroxine) presenting with reported allergic reaction. Patient reports that she had received the COVID vaccine today and 10 minutes later, started to have room-spinning dizziness to the point that she thought she was going to fall out of her chair. She also reports that she started to shake, had shortness to breath, and felt her heart rate increase. Patient had notified staff at the vaccination center and was immediately administered an Epi pen to her left thigh and brought down to the ED. She states that she then started ""twitching everywhere"" and notes chills as well as a scratchy throat, which are still present. She denies any previous similar symptoms as well as any feelings of anxiety prior to the vaccine or difficulty breathing. She reports an allergy to bees and seasonal allergies, but denies any other known drug allergies. No evidence of anaphylaxis or airway compromise. Discussed rebound potential; feel home observation reasonable. Instructed on antigen avoidence. Patient reports she received the vaccine and epinephrine around 9am. She was observed in the ED for 4 hours post injection without complication. Reports shakiness and tingling after epi has resolved. Patient feels better by 1pm and goes home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,WRK,,,,,bee venom,"['Chills', 'Dizziness', 'Dyspnoea', 'Flushing', 'Heart rate increased', 'Muscle twitching', 'Throat irritation', 'Tremor']",1,PFIZER\BIONTECH,IM 1046204,NC,69.0,F,"Fever of 102 degrees, headache lasting for 12 hours. Tylenol taken.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/14/2021,02/15/2021,1.0,OTH,"Warfarin, levothyroxin, statin.",None.,"Clotting factors, hypothyroid.",,"Penicillin, Sentra, primaxin.","['Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1046205,IA,38.0,F,"pt was seen in the Medical Center, ED with c/o tingling face, mouth, throat, headache and feeling of difficulty breathing within 30 min after receiving vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,"tegretrol, MVI, Ditropan, K+, dyazide, calcium,",none,"seizure disorder, dependent edema, obesity, OSA on CPAP, axiety",,"Seroquel, nitrofurantoin, psedophedrine, zinc, paroxetine, codeine","['Dyspnoea', 'Headache', 'Paraesthesia', 'Paraesthesia oral', 'Pharyngeal paraesthesia']",UNK,MODERNA, 1046206,NY,69.0,F,"PATIENT LEFT FACILITY AFTER OBSERVATION PERIOD WAS COMPLETE. PATIENT RETURNED TO FACILITY AND REPORTED ""LIKE A WALNUT"" IN THE THROAT. EPI ADMINISTERED IN LEFT THIGH. 911 CALLED. EMTS ARRIVED STARTED IV BENEDRYL AND ZOFRAN. PATIENT TRANSPORTED TO HOSPITAL FOR FURTHER EVALUATION.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/12/2021,0.0,OTH,NONE REPORTED,NONE REPORTED,NONE REPORTED,,NONE REPORTED,['Sensation of foreign body'],2,MODERNA,IM 1046207,CA,53.0,F,"A day after the vaccine I developed 4 bumps inside my lips (like cold sores). But this report is about developing Covid Arm 8 days after the vaccine. My arm started aching and my muscle felt tight. When I looked I saw a big red circle around the injection site. It was warm to the touch and sore. I looked it up and found out that it was something that some people get. I have not recovered yet, but expect to in a few days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PVT,Synthroid for low thyroid,N0,No,,No,"['Cheilitis', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Muscle tightness', 'Oral herpes', 'Pain in extremity']",UNK,MODERNA, 1046208,OR,33.0,F,"poofyness, itching (hives), shortness of breath, headache, dizziness when upright, joints hurt microdosing benadryl, inhaler",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,OTH,"claritin, zyrtec, wellbutrin, flomax , trazadone",none,"asthma, neuropathy, arthritis, GERD","itchiness, asthma","wheat, crustaceans, some nuts, corn, environmental (grass, trees, pollen, etc), animals (horses, cats, etc)","['Arthralgia', 'Dizziness postural', 'Dyspnoea', 'Headache', 'Pruritus', 'Skin swelling', 'Urticaria']",2,PFIZER\BIONTECH,SYR 1046209,NY,50.0,F,"initially, nausea and dizziness, followed by feeling that throat was closing. Self administered Epipen. Taken to Hospital, given 50mg Benadryl and 10mg Decadron IV en route. Hands and feet turning purple, patient c/o being very cold. In ED, met by MDs, given another dose of Benadry and Decadron and pepcid. She started to have difficulty breathing and they stopped the IV meds, bolused her with fluids and she responded well. Additionally, she was put in sitting position and chest and back were massaged.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,02/19/2021,02/19/2021,0.0,PUB,"Gabapentin 800mg 5 times daily, mulitvitamin, Vit B12, Vit C.",ear infection 2/12 - Ciprodex completed on 2/18,"psoriasis, vagal nerve neuropathy, celiac disease, sleep apnea, vocal chord paresis, dysphonia, laryngeal reflux",,"Sulfa meds, amoxacillin, various env. allergies, shellfish, peanut oil, egg, milk","['Chest X-ray', 'Differential white blood cell count', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Feeling cold', 'Full blood count', 'Influenza A virus test', 'Influenza B virus test', 'Influenza virus test negative', 'Laboratory test', 'Nausea', 'Respiratory syncytial virus test', 'SARS-CoV-2 test negative', 'Skin discolouration', 'Throat tightness', 'White blood cell count increased']",2,MODERNA,IM 1046210,FL,56.0,F,"I had the usual arm soreness like any vaccine which completely dissipated after 48 hours. On day 6 after injection, the injection site began swelling and getting hard. On day 7 the area had grown nearly twice in size, it was harder, red, hot, and I had a fever of 100.6 & headache but all clinics were closed when the fever developed. On day 8, the hardness had moved up to my shoulder, was harder, redder, hotter, headache but I had no fever. The urgent care clinic prescribed amoxicillin and clavulanate potassium tablets (500 mg, 2x/day for 10 days) and OTC antihistamines. On day 9 it was only slightly better. It is still hot, swollen, & hard. The headache is gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/19/2021,6.0,OTH,"Tricor, metformin, allopurinol, estragel, Multivitamin, calcium, vitamin C & D, vitamin B complex, vitamin E",None,"Type II diabetes, normal osteoarthritis, osteopenia",,None,"['Headache', 'Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 1046211,AZ,20.0,F,"Began with headache at 3pm, progressively got more sore in joints until 5pm when my whole body was sore and it was difficult to move. Around 7pm i felt dizzy and chilly, at 1am i threw up and had very bad chills and was still sore, at 7am the next morning i realized my vaccine site was swollen and bruised and felt like a large lump, the skin was rough and very hot to the touch. over the next day i had rolling headaches and nausea and it was difficult to move without pain in my extremities, this started to lessen over the next days but my arm is still swollen, hot, lumped, and painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,OTH,"Fluoxetine, Propranolol",none,none,,"lemon, cantaloupe, peas, carrot","['Arthralgia', 'Chills', 'Dizziness', 'Dry skin', 'Feeling cold', 'Headache', 'Mobility decreased', 'Nausea', 'Pain', 'Pain in extremity', 'Vaccination site bruising', 'Vaccination site mass', 'Vaccination site pain', 'Vaccination site reaction', 'Vaccination site swelling', 'Vaccination site warmth', 'Vomiting']",2,MODERNA,SYR 1046212,MI,58.0,F,Patient experienced allergic Rx. Onsite EMS was called vitals BP 149/89 HR 60 99% O2 room,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/17/2021,0.0,PUB,,,,,,['Hypersensitivity'],1,MODERNA,IM 1046213,MD,77.0,F,one week after injection have red rash and itching for past 5 days with no lessening of symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/18/2021,8.0,OTH,"Eliquis, Metoprolol, Lasix, Aspirin, Atorvastatin, Digoxin, Calcium and Vitamin D",,Atrial fibrillation,,"Amiodarone, Diltiazem","['Pruritus', 'Rash erythematous']",1,MODERNA,IM 1046214,,75.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046215,CO,60.0,M,"Fever and diaphoresis 2/12/21, followed by neck pain starting 2/13/21. Hospital admission with sepsis with right-sided cervical lymphadenitis without abscess 2/17/21. Treated with Unasyn.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,02/12/2021,02/17/2021,5.0,PVT,,,,,,"['Hyperhidrosis', 'Lymphadenitis', 'Neck pain', 'Pyrexia', 'Sepsis']",2,MODERNA,IM 1046216,GA,58.0,F,"Had some itching on day 2 but it went away. Around February 19, I noticed the itching had returned along with swelling in a larger area than the itchy area from day 2.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/20/2021,8.0,PVT,"Vitamin C , Multi Vitamin, Vitamin E, Metformin, Breo, Meloxicam, Glimperide, Trulicity, Lisinopril HCTZ, Amlodipine, Esomeprazole Magnesium",Non,"Asthma, Hyptertension, Diabetes",,"Aspirin, Codeine, Penicillin","['Pruritus', 'Swelling']",1,MODERNA,IM 1046217,NY,74.0,M,"1/21 slept 16 hrs. was up for 4 hrs then slept for 12 hrs. following 10 days felt yukky, sleeping 10 hrs or more. fuzzy thinking disallowed concentrated work. tooth ache started gradually then became strong enuf to take ibuprophen and buffered vitamin C, as well as occasional chelated magnesium and potasium,; it slowly departed as the yukkiness ended. No muscle ache. After vaccination I lifted weights, stretched arm and took very cold and very warm showers on the area. My theory was dispurse the concentration to avoid the muscle ache. Maybe so. But it may have lead to full body adverse event. I call it ""corona light."" yesterday I rec'd 015M20A. so far left arm site slightly swollen, aches, small pain with light touch (avoiding any movement of arm). so far so good.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/21/2021,2.0,OTH,"yes for heart arhythmia, blood pressure, cholesterol, stomach, gums, B12, D3.",none,"excellent, with exercise and healthy diet.",,none,"['Disturbance in attention', 'Feeling abnormal', 'Hypersomnia', 'Injection site pain', 'Injection site swelling', 'Pain', 'Toothache']",1,MODERNA,IM 1046218,FL,79.0,F,"swollen, hot to the touch, itchy at site of injection. No treatment to date. Outcome: ongoing",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/21/2021,9.0,PVT,"metoprolol, omeprazole triamt/hctz cap, lovastatin, premarin, zinc, vitC, E, beta carotene, probiotic, multivitamin",none,none,,"sulfa, keflex, clindamycin, flonase","['Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,PFIZER\BIONTECH,IM 1046219,MD,70.0,F,"Aside from expected soreness at injection site, no adverse reactions through rest of Feb 10 and all of Feb 11 and 12 Starting February 13 and continuing through today (Feb 22), I have had the following symptoms: Vestibular migraine - very severe at the beginning, receding with time, but still concerning Nausea - on and off for full period, no relation to food intake Fatigue - tired most all of the time, could fall asleep at any time Balance - variable for this period, no falls, but do not feel safe to drive",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/13/2021,3.0,UNK,Famotidine Omeprazole Glipizide Crestor Diltiazem Lorsartan Propafenone Xarelto Propylthiouracil,No short term illnesses,"High blood pressure, well controlled by meds High cholesterol, well controlled by meds Hyperactive thyroid, well controlled by meds Atrial fibrillation (rare), well controlled by meds Type 2 Diabetes, well controlled by meds",,IV contrast Fish,"['Fatigue', 'Injection site pain', 'Nausea', 'Vestibular migraine']",UNK,PFIZER\BIONTECH,IM 1046220,,29.0,F,"Redness chest, neck , upper body shoulders and neck. 10:30 am redness and itching improving. 11:15am improved, discharged home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,UNK,,,,29 y/o severe itching and redness chest and neck,,"['Erythema', 'Pruritus']",2,MODERNA,IM 1046221,MD,51.0,F,"Large red, itchy rash spreading from injection site down and across arm starting 12 days after 1st vaccine dose, continues to itch 2 days later, has gotten larger and has raised edges.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/20/2021,12.0,PUB,"carvedilol, telmisartan, fish oil cap, ginger cap, cinnamon cap, marine collagen cap, multivitamin, probiotic cap",none,high blood pressure,,nka,"['Injection site reaction', 'Rash', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",1,MODERNA,IM 1046222,,48.0,F,Big blister on right ankle since 02/17/2021 minutes after my second vaccine dose,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,PVT,None,None,None,,None,['Blister'],UNK,MODERNA, 1046223,,77.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046224,IL,,U,SEVERE HEADACHE,Not Reported,,Not Reported,Not Reported,,Not Reported,,,,,OTH,,,,,,['Headache'],1,MODERNA,IM 1046225,,44.0,F,"4 days after injection developed axillary lymphadenopathy with soreness from under the arm extending to the L breast causing pain with sleeping on that side, no erythema or edema, no fever or chills, resolved after 2 days with ibuprofen, cool/ice compresses",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/16/2021,4.0,PUB,,,,,Codeine - itching,"['Breast pain', 'Lymphadenopathy']",1,MODERNA,IM 1046226,CA,68.0,F,Itchy red upper arm started approximately 5 days post-injection on the deltoid muscle of the left arm. Had been given a Vit B-12 shot in the same arm 4 days prior. Approximately 4 inches in circumference.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/20/2021,4.0,WRK,"Revlimid, colesevelam, acyclovir, aspirin 81 mg, vitamin c",,Multiple myeloma,,,"['Injection site erythema', 'Injection site pruritus']",2,MODERNA,IM 1046227,CA,71.0,M,About an hour after the shot I felt nauseous and light-headed and a little mild weakness. It sort of came in mild waves over the course of 2 to 3 hours. Never really disabled me just bothersome and made me want to just sit. Symptoms seemed to disappear after I ate supper. I felt fine the next morning save fore some soreness just below the injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,PHM,None,None,None,,None,"['Asthenia', 'Dizziness', 'Injection site pain', 'Nausea']",1,MODERNA,IM 1046228,DE,34.0,F,"Face became tingly and numb - lasted about 10 minutes Later that night I also experienced tingling and numbness and heaviness of the left side of my body (specifically arm and leg) on the affected/vaccinated side, drouth, and sleeplessness for about 2 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,OTH,"Plexus supplements: slim hunger control, bio cleanse (magnesium), pro biotic, metaburn Fluoxetine 20mg Claritin 24 hr 10mg B12 supplement Cal-mag-zinc D3 (2000IU)",,Chronic Lyme Disease (est. 1998 and 2000),,Tetracycline,"['Hypoaesthesia', 'Insomnia', 'Limb discomfort', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 1046229,,78.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Product preparation issue'],2,PFIZER\BIONTECH,IM 1046230,OK,68.0,M,Death. My father-in-law was found unexpectedly deceased in his home Saturday morning. He worked the previous day.,Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/20/2021,16.0,PUB,,Diabetes,Diabetes,,,['Death'],1,MODERNA,IM 1046231,IL,51.0,F,Covid Arm - red and sore at injection site 8 days following vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/13/2021,02/21/2021,8.0,PUB,"Zyrtec, Fish oil, Curcumin, probiotics",None,None,,"sulfa, penicillin, ibuprofen, codeine","['Injection site erythema', 'Injection site pain']",1,MODERNA,IM 1046232,MI,80.0,F,Emesis X 2,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/30/2021,01/31/2021,1.0,SEN,,,,,,['Vomiting'],UNK,MODERNA,IM 1046233,KY,78.0,M,Boost dose given prior to recommended 28 day interval. (given on day 20),Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/12/2021,0.0,PUB,,,,,,['Inappropriate schedule of product administration'],UNK,MODERNA,IM 1046234,,78.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046235,IL,34.0,F,"PATIENT STARTED ITCHING WITHIN 15 MINUTES OF BEING VACCINATED AND DEVELOPED HIVES. SHE WAS GIVEN BENADRYL IM AND WAS ADVISED TO TAKE BENARYL LATER IN THE DAY IF NEEDED. SHE STATES SHE TOOK MOVE BENADRYL LATER IN THE EVENING. SHE STATED SHE WAS WEAK, DEVELOPED A LOW-GRADE FEVER, AND OTHER FLU-LIKE SYMPTOMS.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,MIL,UNKNOWN,RHEUMATOID ARTHITIS AND ANEMIA,RHEUMATOID ARTHITIS AND ANEMIA,,NEXIUM,"['Asthenia', 'Influenza like illness', 'Pruritus', 'Pyrexia', 'Urticaria']",1,MODERNA,IM 1046236,CA,74.0,F,"Redness at vaccination site, hardness and itching around site - Covid arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/16/2021,2.0,PHM,Vitamins,None,None,,Latex,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus']",UNK,MODERNA,SYR 1046238,,,U,"HEADACHE, BODY PAIN, AND FEVER",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 1046239,MD,25.0,F,"12/28 Vaccination 1/4 6-7 days lays, adenopathy, cervical lymph node swelling. HA relieved by Tylenol. Mild arm pain, similar flu shot. 48 hours later cleared up after taking Benadryl. Saw occupational health. Prescribed Claritin, hydrocortisone cream.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,PUB,Birth control,,endometriosis,,Latex (sensitivity),"['Headache', 'Lymphadenopathy', 'Pain in extremity']",1,MODERNA,SYR 1046240,AZ,79.0,F,"Redness on the thighs, legs, and chest. very little redness on my arm(s). I was watching tv 3 days after receiving the vaccine and my palms were suddenly blue and I could see every vein in my hands and fingers. they were cold and color returned after submerging them in warm water.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/13/2021,2.0,OTH,Plavix Losartan Toprol Zetia Aspirin Multi vitamin D C Fish oil,No,Arthritis,,Penicillin Vicodin,"['Cyanosis', 'Erythema', 'Peripheral coldness']",1,PFIZER\BIONTECH,SYR 1046242,,44.0,F,"6 days after injection developed redness (2 inch diameter), edema, itching, firmness to injection site and axillary lymphadenopathy with soreness from under the arm extending to the L breast causing pain with sleeping on that side, no erythema or edema to axillary or chest areas, no fever or chills, resolving after 2 days with ibuprofen, cool/ice compresses, benadryl cream to site Saw pt by televisit and looks like injection might have been given too low and might have been SC instead of IM",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/18/2021,6.0,PUB,,,,,"penicillin, Ceclor - hives; unknown substance-anaphylaxis","['Breast pain', 'Injection site erythema', 'Injection site indentation', 'Injection site oedema', 'Injection site pruritus', 'Lymphadenopathy']",1,MODERNA,IM 1046243,,45.0,F,"First Lot 025L20A Moderna Reactions Head ache, lips swelling. Diarrhea, stomach issues, dizzy, fatigue, chills in feet and hands. Second one Headache, nausea, fatigue, body aches, joint pain. Vaccine site real sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/18/2021,0.0,UNK,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Vaccination site pain']",2,MODERNA,SYR 1046244,OH,45.0,F,"Woke up on 02/14/2021 and had no sense of taste or smell. 2 negative covid tests. Also extreme fatigue, shortness of breath, increased HR with little to no movement noticed. Occasional chest pains. To this date, the symptoms still exist.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/14/2021,1.0,PVT,"Tylenol, Nasal Saline rinse, flonase, singular",None,Allergies-environmental; had outpatient sinus surgery on 2/10/21 uncomplicated,,none,"['Ageusia', 'Anosmia', 'Chest pain', 'Dyspnoea', 'Fatigue', 'Heart rate increased', 'SARS-CoV-2 test negative']",2,MODERNA,SYR 1046245,,75.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046246,NJ,46.0,F,"I already have chronic urticaria but it is well-managed by taking Allegra, QD (OTC). I had to increase my dose of Allegra to BID because the itching has intensified. I am getting an increased amount of random red/swollen itchy spots, mostly in my extremities. Other adverse events present post dose include: nausea, fatigue, mild headache and mild dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/19/2021,2.0,PVT,"Allegra; Zoloft; Spironolactone; Vitamin C, Zinc",,PCOS; chronic urticaria; pre-diabetic; obesity,,,"['Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pruritus', 'Rash papular']",1,MODERNA,SYR 1046247,KY,76.0,F,Boost doses given prior to 28 days (given on day 20),Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,PUB,,,,,,['Inappropriate schedule of product administration'],UNK,MODERNA,IM 1046249,KY,72.0,F,Patient received Pfizer Covid vaccine # 1 02/05/2021. She developed the bumps on scalp (15 raised nodules and sores around her mouth). She states the bumps wer not itchy and were no where else but on scalp. The sores around mouth were non vessicular. She did not present until 02/13/2021 and had taken steroids at home as she has so many reactions. 1 day she took 20 mg and the next 10 mg. several days later another 10 mg pill. On 02/13/2021 the scalp bumps not the lip sores were non visible. The was 1 raised area on the side of left face that appeared to be a stuck on lesion. She states the steroids took car of the rest. She was instructed to follow up with PCP and Dr to see if she should take second vaccine. Er for any s/s of distress. I dod not give her any additional therapy as the symptoms had abated.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/07/2021,2.0,PVT,"zyrtec 10 mg daily by mouth, Vitamin D3 2000iu daily by mouth, Calcium 600 plus twice daily by mouth, vitamin B-12 500 daily by mouth, Multi-vitamin with minerals for women daily by mouth, Vitamin C 500 mg daily by mouty, Losartan daily",none,"hypertension psoriasis allergies to red, yellow and blue dye",,"food dyes(red, yellow and blue)-rash macrolides-rash Quinolones-rash Penicillin-rash ceftin-rash Benazepril-rash Imiquimod topical-bumps on scalp after applying to chest","['Rash', 'Stomatitis', 'Swelling face']",1,PFIZER\BIONTECH,IM 1046250,MI,68.0,F,"Moderna injection on Thursday 2/18/2021, Friday at 7 pm facial swelling and redness appeared. Eyes are swollen, whole face and welts all over, sore throat for 2 days, Denies fever. Mild wheezing/little winded. Welts over whole body, hips and ankle. Itching in unusual places. Denies swollen tongue. Seen on 2/20/21 at urgent care.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,UNK,"albuterol HFA (PROVENTIL HFA, VENTOLIN HFA, PROAIR HFA) 108 (90 Base) MCG/ACT inhaler aspirin-acetaminophen-caffeine (EXCEDRIN MIGRAINE) 250-250-65 MG per tablet EPINEPHrine 0.3 MG/0.3ML auto-injector Fluticasone-Salmeterol 113-14 MCG/ACT i",,"Respiratory Mild intermittent asthma without complication � Nervous Chronic migraine Neck pain � Genitourinary Microscopic hematuria- Negative Cytology 11/17/10 Normal CT 11/22/10 � Endocrine/Metabolic Impaired fasting glucose Mixed hyperlipidemia IFG (impaired fasting glucose) � Other Situational anxiety Chronic idiopathic urticaria Angioedema, initial encounter",Similar reaction to Shingles vaccines in the past.,wasp sting caused anaphalyxis,"['Dyspnoea', 'Erythema', 'Eye swelling', 'Oropharyngeal pain', 'Pruritus', 'Swelling face', 'Urticaria', 'Wheezing']",2,MODERNA, 1046251,AZ,29.0,F,Headache: in middle of forehead start date: 2-20-2021 at 9:30pm and ended on 2-21-2021 at 8am. No conmeds taken.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,OTH,,Na,Na,,Na,['Headache'],2,PFIZER\BIONTECH,SYR 1046252,WI,81.0,F,"A few hours after the vaccine, came home and got a headache, then she got nausea. She went to bed, and all night and into the next day had fever/chills. She got up during the night to get some water she collapsed and could not get up as she was so weak. Her husband found her and helped her back to bed. Today, 2/22/21 she is better today and feels almost to normal. She took Pepto-Bismol for the nausea. Tylenol/Ibuprofen did not take the headache, but it did finally go away. The headache was on the top of her head.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,OTH,Centrum one a day.,None.,None.,,None.,"['Chills', 'Fall', 'Headache', 'Nausea', 'Pyrexia']",2,MODERNA,IM 1046253,MD,37.0,F,Patient was admitted for community-acquired pneumonia,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/24/2021,02/12/2021,19.0,PVT,"Incruse, quetiapine, albuterol, amlodipine, aspirin, benzonatate, Symbicort, buspirone, vitamin D, clonazepam, gabapentin, insulin aspart, insulin detemir, lisinopril, lurasidone, metformin, metoprolol tartrate, mirtazapine, Montelukast, pa",,"Anxiety, asthma, COPD, depression, diabetes, GERD, hepatic steatosis, hypertension, lymphedema",,NKA,['Pneumonia'],1,PFIZER\BIONTECH,IM 1046254,MI,89.0,F,"Fatigue, Diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/30/2021,01/30/2021,0.0,SEN,,,,,,"['Diarrhoea', 'Fatigue']",UNK,MODERNA,IM 1046255,CO,52.0,F,"Approximately 1 1/2 hours after injection, severe pain in left shoulder. Injection was given very high-into my shoulder. It has been 16 days and I still have serious pain in my left shoulder. I have never had trouble with either shoulder previously..",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/06/2021,0.0,PUB,,,,,Penicillin,['Arthralgia'],1,PFIZER\BIONTECH,IM 1046256,TX,55.0,F,It started out with itching and redness at the injection site on the morning of the 14th. And this morning its not as red or itchy but the armpit area is sore. This morning I took three Advil. Also the redness is warm to the touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/21/2021,7.0,PHM,levothyroxine 50 mcg daily hydrochlorthiside 25 mg daily progesterone 200 mg daily B complex 500 mg daily vitmine d3+K2 5000 IU and 80 mcg multivitamin probiotic calcium 1200 mg omega 3 w/ EPA + BHA 1400 mg 647 mg (EPA) 253 mg (BHA),No,No,,No,"['Axillary pain', 'Injection site erythema', 'Injection site pruritus']",1,MODERNA,SYR 1046257,WI,64.0,F,"Arm was very sore starting day after injection and for a couple of days. After that there was very slight periodic itch at injection site. Happened a few times a day for several days. On day 8 after vaccine, Feb 20, a raised welt-like patch appeared on arm near the injection site. Measured approximately 2"" x 3"". Lasted for 24 hours. The red area increased and the welt-like raised area subsided the next day. By Feb 22 there was a larger slightly red area left and the periodic itching returned. I am reporting this as it happened so many days after the injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/20/2021,8.0,PHM,"vitamin D, vitamin C, biotin",none,none,,"latex, thimersol (contact not systemic allergy), adhesive on bandaids etc.","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 1046258,IN,79.0,F,"very bad pain from head to toe in every muscle, bone and joint, nausea, weakness, freezing cold and the worst was from about 10 pm feb 18 to about 11 am feb 19 but the weakness went on through feb 20. Felt pretty much over it by Feb 21 but still some weakness and fatigue. Also a very sore arm that turned pink and feb 22 is still sore and pink and itchy but not as bad as the previous days. I have always gotten a sore arm with flu shots but not as bad as this time so I didn't consider that a bad reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PVT,"Armour thyroid, ezetimibe, losartan, latanoprost eye drops, azelastine HCl nasal spray, mometasone furoate nasal spray, vitamin C, Osteoporosis Biflex, one-a-day 50+ female, calcium, super B Complex, Vitamin D3.",none,"hypothyroid, slightly high blood pressure, slightly high cholesterol , glaucoma, dust mite allergen",,dust mite allergen,"['Asthenia', 'Eye pruritus', 'Fatigue', 'Feeling cold', 'Nausea', 'Pain', 'Pain in extremity', 'Pruritus']",2,MODERNA,IM 1046259,,77.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Product preparation issue'],2,PFIZER\BIONTECH,IM 1046260,FL,35.0,F,"ear pruritus in right ear, itchy skin just above affected ear on scalp, and skin behind affected ear and just under ear on throat/neck. All related mild and just a little annoying but I was advised to report it all the same.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,OTH,"Albuteral, evening primrose oil capsules, multivitamin.",None,Mild asthma,"27/28 years, flue shot, blacked out and had very low BP for 2 months after where I had fainting spells from it. I was told it w","Gluten, soy & beets. KNDA","['Ear pruritus', 'Pruritus']",1,PFIZER\BIONTECH,SYR 1046261,KY,51.0,M,Severe pain at/around injection site lasting 2 days; moderate headache lasting 2 days; mild dizziness lasting 1 day; mild fever lasting 1 day; strong muscle and joint pain lasting 2 days; strong fatigue lasting 3 days; general malaise lasting 3 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,WRK,,none,none,new shingles vaccine in 2020,none,"['Arthralgia', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Myalgia', 'Pyrexia']",2,MODERNA,SYR 1046262,CA,80.0,F,Patient received her 2nd dose of moderna vaccine 3 days early then recommended per CDC (on day 21). No adverse RXN.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PUB,ukn,na,na,,ukn,"['Inappropriate schedule of product administration', 'No adverse event']",2,MODERNA,IM 1046263,IL,35.0,F,"Fatigue, Headache, Muscle pain, Joint pain, Chills/sweats, Nausea/vomiting, hard time sleeping, very sever migraine ( rescue medication didnt help)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,WRK,"Amox-Clav, Relpax, Amitriptyline, Dicyclomine, Microgestin 1.5/30 FE Tab, Aimovig Sureclick 140mg/ml Inj (once a month 2/18 - last dose), Spironolactone 25mg",sinus infection,"IBS, anxiety, migraines, depression, asthma, hiatal hernia, allergies, diverticulitis",,"ceftin, codine","['Arthralgia', 'Chills', 'Condition aggravated', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Migraine', 'Myalgia', 'Nausea', 'Sleep disorder', 'Vomiting']",2,MODERNA,IM 1046264,ME,74.0,M,"Nausea, weakness, right arm in pain, extreme tiredness, black patches crossing left eye. Started two days after shot and lasted for 2 days. Bedridden for 2 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/19/2021,2.0,OTH,"Atenolol, simvistatin",none,none,,none,"['Asthenia', 'Fatigue', 'Nausea', 'Pain in extremity', 'Vitreous floaters']",1,MODERNA,SYR 1046265,WA,85.0,M,"Received 2nd dose of COVID19 Pfizer vaccine at 1103 am on 2/19/21, was last seen at 1159, found around 1615 by kitchen staff who were serving dinner.",Yes,02/19/2021,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,SEN,,,"A-fib, dementia, BPH, HTN, CEREBROVASCULAR DISEASE and anemia.",,No known allergies.,['Death'],2,PFIZER\BIONTECH,IM 1046266,,75.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046267,CA,38.0,F,"5:30 pm started with mild Headache. Progressed to nausea and more prnounced HA. At 7:30 began having chills and fever. Slept all day. Awoke with HA and fatigue. My heart felt like it was beating fast with physical activity. Then developed a sorethroat.,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PVT,none,none,none,,nkda,"['Chills', 'Fatigue', 'Headache', 'Heart rate increased', 'Nausea', 'Oropharyngeal pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1046268,IL,,U,LEFT PAIN AND HEADACHE,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,OTH,,,,,,"['Headache', 'Pain']",1,MODERNA,IM 1046269,AZ,70.0,M,Minor rash on chest and lower abdomen,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/07/2021,6.0,PUB,Valocyclovir Lovastatin,None,None,,None,['Rash'],1,PFIZER\BIONTECH,SYR 1046270,,51.0,F,Immediate erythema from injection site down to wrist. Rash on wrist. Resolved in 1-2 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,,12/21/2020,12/21/2020,0.0,PVT,,,,,,"['Erythema', 'Immediate post-injection reaction', 'Injection site erythema', 'Rash']",1,PFIZER\BIONTECH,IM 1046271,,77.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation error']",2,PFIZER\BIONTECH,IM 1046272,,48.0,M,"Temp 100, headache, and body ache",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/11/2021,02/11/2021,0.0,UNK,,,,,,"['Body temperature increased', 'Headache', 'Pain']",1,MODERNA,IM 1046273,WI,29.0,F,numbness and tingling in R arm and neck. Then next day when I followed up with patient the numbness and tingling had resolved and she stated her neck and R shoulder blade area were sore.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PUB,"Spiriva , Combivent inhaler, Singulair, Zyrtec, Sertraline, Dulara",,"Asthma, Depression, Anxiety",,Allergies to several types of animals,"['Back pain', 'Hypoaesthesia', 'Neck pain']",UNK,PFIZER\BIONTECH,IM 1046274,OH,52.0,F,"hives on back, chest and face",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/16/2021,5.0,SCH,synthroid celexa pravachol triamterene medroxyprogesterone,none,asthma/allergies hypothyroid high blood pressure high cholesterol,,amoxicillin egg whites,['Urticaria'],1,MODERNA, 1046275,,76.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation error']",2,PFIZER\BIONTECH,IM 1046276,GA,73.0,F,Left arm goes numb at times. More often in left thumb and index finger. It feels like when your arm falls asleep and then starts to wake up. Tingling feeling but NO pain or discomfort.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,PUB,Prozac Irbestar/hctz Singulair Atorvastatin S[ironolactone,none,High blood pressure High cholesterol,,none,"['Hypoaesthesia', 'Paraesthesia']",1,MODERNA,SYR 1046277,GA,76.0,M,acute nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/17/2021,5.0,PVT,"losartin, autorvasatin, xarelto, metoprolol, D3, aspirin and CO Q10",none,"hbp, aortic anurism, 2 heart attacks, cabag X4",,none,['Nausea'],1,PFIZER\BIONTECH,UN 1046279,CT,27.0,F,"I experienced a red lump at the injection site the night after my second injection. At first, it was a very large red patch and slowly shrunk and felt like a grape was under my skin. It was hot to the touch, very sore and itchy. It lasted 6-7 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/16/2021,1.0,OTH,"Wellbutrin, Vilazodone, Vedolizumab, Mesalamine",,Ulcerative colitis,,Mushrooms,"['Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",2,MODERNA,IM 1046280,ME,71.0,F,"fifty cent sized rash around the injection site, medium itching for 3-4 days, controlled with an antihistamine gel.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/30/2021,7.0,OTH,"Multi vitamin, fish oil, glucosamine/chondroitin",none,none,24 hour flu like symptoms after some yearly flu shots,lactose intolerance,"['Injection site rash', 'Pruritus']",1,MODERNA,IM 1046281,MA,35.0,F,"muscle aches, fatigue, chills, fever (102.9), headache, no appetite- all which lasted about 24hrs - tylenol helped with some symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/11/2021,1.0,PUB,,,"GERD, migraines, IBS",the first Covis-19 vaccine (Moderna),"cherries, almonds, peaches","['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",2,MODERNA,IM 1046282,MI,79.0,F,"Confusion, Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/31/2021,1.0,SEN,,,,,,"['Confusional state', 'Fatigue']",UNK,MODERNA,IM 1046283,FL,57.0,F,"Eight days after the vaccine, I have developed a red swollen area about 2"" in diameter that is sensitive to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PVT,None,None,Asthma,,"Dust mites, soy","['Erythema', 'Hyperaesthesia', 'Swelling']",UNK,MODERNA,IM 1046284,,79.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,SYR 1046285,MI,60.0,F,Patient experienced itching on her head and back 15 minutes after vaccination. Onsite EMS was called vitals BP 193/77 HR 91. No difficulty breathing or swallowing patient had anaphylactic R&N to Idoine she stated the itching she is experiencing is minimal. Symproms were subsiding patient relaesed to home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PUB,"Lantus. Ozempic, Humalog, Benicar, Crestor, HCTZ",,"HTN, Hypercholesterolemia, Diabetes",,Iodine,['Pruritus'],1,MODERNA,IM 1046286,,41.0,F,"Dizziness, not responsive to questions, tachycardia. RRT called and taken to ER but regained normal mentation within minutes and discharged without further treatment. History of similar responses to flu vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Dizziness', 'Tachycardia', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 1046287,TX,57.0,F,"headache, Injection location in right arm experienced excess tenderness, swelling and warm to the touch., excessive fatigue, light buzzing sensation, excessive chills muscle aches all over an d , lower back tightness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,OTH,daily vitamins,none,none,,No,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Muscle tightness', 'Pain', 'Sensory disturbance']",2,MODERNA,SYR 1046288,,79.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Product preparation issue'],2,PFIZER\BIONTECH,IM 1046289,VA,64.0,F,"Patient received vaccine 17Feb21. Within 24hrs pt developed radiating pain from shoulder to neck that has lasted since today, 22Feb. Of note pt recently had back surgery on 30Nov20 which she states is contributing to her pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/17/2021,0.0,MIL,,,,,,"['Arthralgia', 'Neck pain', 'Spinal operation']",1,PFIZER\BIONTECH,IM 1046290,WI,37.0,F,Petechiae on arms chest and abdomen.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/25/2021,0.0,PVT,,,,,,['Petechiae'],2,MODERNA,IM 1046291,NC,86.0,F,"I had a rash on the inner arm and on my hands. I took a Benadryl, and then the rash started to recede.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/19/2021,8.0,OTH,None,No,No,,penicillin sulfa,['Rash'],1,MODERNA,SYR 1046292,NY,66.0,F,Seven days after receiving Moderna's first covid vaccine the arm that it was administrated in developed a large round slightly swollen red rash that is hot and itchy at times.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,PHM,"Aspirin 81mg, Metoprolol ER Succinate 100mg, Rosuvastiatin 40 mg., Losartan/HCTZ 50/12.5mg, Lansoprozole 30mg. Vitamin D3 and C",none,"High Blood Pressure, Acid reflux, High Cholesterol",Flu Vaccine,None (possible allergic reaction to the Moderna's first Covid 19 vaccination,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 1046293,,86.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Incorrect dose administered'],2,PFIZER\BIONTECH,SYR 1046294,IL,49.0,F,HEADACHE AND DIZZINESS,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,OTH,,,,,,"['Dizziness', 'Headache']",1,MODERNA,IM 1046295,OR,23.0,F,"pt had vaccine, waited 15 min after, than vomited twice",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,denies,denies,,,denies,['Vomiting'],2,MODERNA,IM 1046296,CO,70.0,M,"After receiving the 1st dose of Moderna Covid-19 vaccine about 11:30 am on 2/18/21: 1. About 4:00 pm that same afternoon I started to feel some soreness around the injection area and a slight headache. 2. By about 7:00 pm that same evening the soreness and headache had increased and I was feeling general body achiness. It was much worse sitting or standing so I ate a small dinner and then went to bed to lie down. I felt much better to be prone. 3. I normally go to sleep between 11 pm to 1 am but fell asleep around 8:20 pm. When I go to sleep that early I often wake up during the night and will be awake for a few hours before falling asleep again. That is what happened. I slept about 3.5 to 4 hours then was up for about 3 hours then went to sleep again for about 3 to 4 hours. I think I got about 7 hours sleep which was good since my typical is about 6 hours. 4. I woke up the morning of one day after and still felt the same, that is, my arm was very sore, and somewhat swollen, around the injection area, and I had a headache and general body achiness, and it was worse sitting and standing and much better lying down prone. Other than getting something to eat I stayed prone most of the day until later afternoon when I did manage to be sitting up for several hours. 5. By the time I went to sleep that night, again a little earlier than normal but maybe around 10 pm, my arm was very sore, and pretty swollen, around the injection area, and I had a headache and general body achiness. 6. By the time I awoke on the morning two days after the vaccination, that is 2/20/21, everything was reduced but still there, that is, my arm was still sore and swollen but much less from the peak, and I had a mild headache and the body aches were pretty much gone. 7. By the time I awoke on the morning of 3 days after, that is 2/21/21, I felt normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PUB,"Latanaprost eye drops once per eye every night, Vitamin C 2000 to 4000 mg per day",none,none,,none,"['Headache', 'Injection site pain', 'Injection site swelling', 'Pain']",1,MODERNA,SYR 1046297,IL,78.0,M,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/18/2021,1.0,PUB,"Dizzyness, Chils, Headache, Muscle Aches, Joint pain, Fatigue, Nausea, Lack of Appetite, Loss of Balance.","Taking Blood pressure medication, Moderate Kidney Disease",,Shingrix,Suspect that when I had my second Shingrix shot and an adverse reaction that may have been an indication that might be a clue. I do not normally get vaccinated for the flu. Recent vaccinations include: Shingrix Diptheria-tetanus-pertussis vaccine,['Unevaluable event'],UNK,MODERNA, 1046298,NC,69.0,F,"Very sore arm showed up a few days following the shot. Redness in circle and hard to the touch. Painful. I understand there is something called ""Covid arm."" It did not itch; just pain. Not keeping me from getting 2nd shot. Will use other arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/17/2021,5.0,SCH,"Duloxetine, Meloxicam, Montelukast, Vit. C, turmeric, acidolphilus",none,"Asthma, arthritis",,none,"['Erythema', 'Induration', 'Pain in extremity']",1,MODERNA,IM 1046299,WA,41.0,F,"Individual complained of feeling a little tingling in her throat and on her tongue. The assigned PA directed that staff member would need 2- 50 mg Benadryl capsules PO. Yes- we did have an epi pen next to us. VS: BP 137/82, O2 SAT 99%, HR 89 minute. Vitals at 10 minutes post symptoms/Benadryl BP 160/89, P 82/min, O2 SAT 100%, 15 minutes post symptoms/Benadryl BP 139/91, P 81/min, O2 SAT 99% No symptoms per staff member's verbal statement. She returned to work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,OTH,,,,,,"['Paraesthesia oral', 'Pharyngeal paraesthesia']",1,MODERNA,IM 1046300,,77.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Incorrect dose administered'],2,PFIZER\BIONTECH,IM 1046301,MD,79.0,M,"Patient admitted and treated for respiratory insufficiency, CHF, hypotension, AKI, metabolic acidosis, and hyperuricemia",Not Reported,,Not Reported,Yes,7.0,Not Reported,U,02/04/2021,02/12/2021,8.0,PVT,"quetiapine, acetaminophen, allopurinol, aspirin, azithromycin, bumetanide, clopidogrel, escitalopram, ferrous sulfate, Breo Ellipta, glipizide, glucosamine, insulin NPH. insulin lispro, levothyroxine, lidocaine patch, loratadine, lovastatin",,"anxiety, arthritis, BPH, CAD, CHF, COPD, chronic renal insufficiency, depression, diabetes, DVT, GERD, GIB, hypertension, hyperlipidemia, hypothyroidism, OSA, PAD, ulcerative colitis",,"oxycodone (hallucinations), sulfa antibiotics (itching), hydrocodone (hallucination), erythromycin (nausea and vomiting)","['Acute kidney injury', 'Cardiac failure congestive', 'Hyperuricaemia', 'Hypotension', 'Metabolic acidosis', 'Respiratory failure']",1,MODERNA,IM 1046302,OR,75.0,F,"The patient described throat tightness and mild shortness of breath. Vital signs were normal (including O2 sat of 99%). Although the symptoms improved over the course of 35 minutes, they did not resolve, so she was taken to the local ED for additional monitoring.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/21/2021,02/21/2021,0.0,PVT,Albuterol Liothyronine,Hammer toe and hallux defomity s/p foot surgery,Asthma Hypothyroidism Chronic fatigue Dyspepsia Osteopenia Osteoarthritis,,"NSAIDs (ibuprofen, naproxen, maloxicam) Aspirin Sulfa drugs","['Dyspnoea', 'Throat tightness']",1,MODERNA, 1046303,PR,78.0,M,"PNEUMONIA, HYPOXIA",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/28/2021,02/16/2021,19.0,PVT,"NORVASC, ATENOLOL, CLONAZEPAM, FAMOTIDINE, LOSARTAN, TEMAZEPAM",NOT,"HYPERTENSION, DEMENTIA",,DO NOT,"['Hypoxia', 'Pneumonia']",1,PFIZER\BIONTECH,IM 1046304,NE,60.0,M,First does was Moderna. Second dose given was Pfizer.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2011,02/11/2021,3663.0,PUB,,,,,,['Interchange of vaccine products'],2,PFIZER\BIONTECH,IM 1046305,,79.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Incorrect dose administered'],2,PFIZER\BIONTECH,IM 1046306,NE,81.0,F,"Per patient's daughter: around 1 pm patient started acting confused. At one point, patient thought it was Valentine's Day. Daughter also stated that patient ate a Kleenex. Patient was treated with 2 L of fluids and cardiac monitoring. Patient's AMS resolved by next morning. Patient returned to baseline and was discharged after 36 hours of observation.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/18/2021,02/19/2021,1.0,UNK,"Acetaminophen, albuterol HFA, allopurinol, apixaban, aspirin, atorvastatin, bupropion, calcitriol, citalopram, colchicine, gabapentin, hydrocodone/acetaminophen, levothyroxine, lisinopril, omeprazole, Anoro Ellipta, Vitamin B12, Vitamin D2,",,"OSA, COPD, hypertension, obesity, CKD, dyslipidemia, gout, hyperthyroidism, depression",,"Codeine, Morphine","['Blood creatinine increased', 'Cardiac monitoring', 'Chest X-ray normal', 'Confusional state', 'Foreign body ingestion', 'Mental status changes', 'Respiratory viral panel', 'Respirovirus test', 'Troponin', 'Urine analysis normal']",1,MODERNA,IM 1046307,MD,25.0,F,"1/25 vaccination 1/26 I couldn't sleep overnight, kept waking up . Arm pain, 101.8 temp, muscle aches, severe fatigue, joint pain. *had to take 2 days off of work. 48 hours after vaccination, rash with itching at injection site. Went away after 24 hours with Benadryl and hydrocortisone cream. Within 48 hours, fever broke.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/26/2021,1.0,PUB,birth control,,Endometriosis,COVID 19; 12/28/2020,latex (sensitivity),"['Arthralgia', 'Fatigue', 'Impaired work ability', 'Injection site pruritus', 'Injection site rash', 'Insomnia', 'Myalgia', 'Pain in extremity', 'Pyrexia']",2,MODERNA,SYR 1046308,CA,61.0,F,"Awakened by very painful left arm (7 on 1-10 scale), headache (3-4), general discomfort and restlessness. Within one hour, progressed to bone-rattling, teeth-chattering chills and inability to get warm for several hours, neck and low back pain (7-8), general intense fatigue but inability to sleep because of other discomforts. Over-the-counter Tylenol and a warm magnesium bath temporarily diminished symptoms, but relief was short-lived. Symptoms progressed in early afternoon to diarrhea for about 2 hours and increased fatigue, temperature up to 100.2 (my normal 97.6), headache pain progressed to 4-5, neck and low back remained 7-8. Tylenol seemed to have no effect. Evening (5pm) brought nausea and increased overall discomfort, fatigue, and pain. Aspirin - no effect. At 11:30 p.m. I took Motrin 600 mg and was then able to doze off and on. Throughout I remained very thirsty and consumed many glasses of water and herbal tea. Awoke at 3:45 a.m. 2/22 with only very slight headache, no nausea. Slept soundly until 6:30 a.m. Some fatigue persists, with left-sided pain (5-6) in neck and low back. Left arm remains sore (3-4). No great appetite, but no nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PHM,"levothyroxine, flaxseed oil, circumen, evening primrose oil, milk thistle","none - though did test positive PCR test for COVID19 on 12/17/2020, mild case. fully recovered",hypothyroidism,,seasonal allergies only,"['Back pain', 'Chills', 'Diarrhoea', 'Discomfort', 'Fatigue', 'Feeling cold', 'Headache', 'Insomnia', 'Nausea', 'Neck pain', 'Pain in extremity', 'Pyrexia', 'Restlessness', 'Thirst']",1,MODERNA,IM 1046309,GA,44.0,F,"Started with nausea and Headache the day of the vaccine shot. The following day I had nausea, throwing up, light-headed, and actually blacked out momentarily. Treatment included: taking Excedrin for Migraines and an anti nausea medication. I slept for most of the day following the shot and the entire night the next day and the next night. All total sleep was probably a total of 25 - 30 hours of a 48 hour period following the vaccine. Still feeling nauseous and having headaches five days after taking the shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,OTH,None,None,None,,Bee Stings,"['Dizziness', 'Headache', 'Loss of consciousness', 'Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH,SYR 1046310,,37.0,F,"Pregnancy EDD 5/22. Approximately 21 weeks at time of vaccination. Had flu-like symptoms that started approximately 12 hours after vaccine. I felt weak, achy and tired. Symptoms resolved around 36 hours after vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/13/2021,1.0,UNK,"Prenatal vitamin, 81mg aspirin",none,none,,none,"['Asthenia', 'Discomfort', 'Fatigue', 'Foetal exposure during pregnancy', 'Influenza like illness']",UNK,PFIZER\BIONTECH, 1046311,,79.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Incorrect dose administered'],2,PFIZER\BIONTECH,IM 1046312,CA,88.0,F,"patient c/o dizziness at 4:59pm. V/S Bp 130/80 mmttg , 74 bpm 18 cpm 98% o2 SAT RA #21 Pt stable and sent home",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/18/2021,0.0,OTH,,,,,,['Dizziness'],1,PFIZER\BIONTECH,IM 1046313,TX,38.0,F,"muscle pains, site pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,UNK,UNK,UNK,,UNK,"['Injection site pain', 'Myalgia']",1,MODERNA,IM 1046314,FL,73.0,F,"red rash approx 6 inches x 2 inches, surrounded by red, swollen area approx 4 inches x 6 inches; severe itching continuing today, 2/22/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/19/2021,6.0,PVT,"levothyroxine, mirtazapine, atorvastatin, omeprazole, calcium, magnesium, L-lysine, multivitamin.",none,hypothyroid,,"ampicillin, mango sap, sumac","['Peripheral swelling', 'Pruritus', 'Rash erythematous']",2,MODERNA,IM 1046315,KY,75.0,F,"Full body diffuse rash red circles all over body, (completely covered) head to toe, extremely itchy. Patient was prescribed medrol dose pack and the rash is now almost completely gone 2/23 when I called and check on her again.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/13/2021,2.0,PHM,"Metformin, Imdur, Effexor, Cartia, Flexeril, Crestor, metoprolol",None,"Diabetes, Heart Disease,",,No Allergy,"['Pruritus', 'Rash']",1,MODERNA,IM 1046316,IN,65.0,F,"Large red rash patch on vaccine arm, about 3 inches in diameter, darker around the edge. Appeared on Day 12 after the first shot. Did not hurt, barely itchy only twice in two days, and just slightly warm to the touch. Lasted two days; faded nearly away by the third day after its appearance.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/18/2021,12.0,PHM,Atenolol Loratadine Amabelz Low-dose aspirin One-a-Day vitamin,None,High blood pressure Obesity Mild asthma,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth', 'Rash erythematous']",2,MODERNA,SYR 1046317,OH,86.0,M,Patient passed away from chronic respiratory failure with cardiogenic shock 24 hours from 2nd dose of vaccine. Patient with longstanding history of pulmonary HTN and heart failure with desire for comfort care only. Entering into VAERS out of abundance of caution.,Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/12/2021,1.0,PVT,"albuterol inhaler, allopurinol, amlodipine, aspirin, atorvastatin, bumex, cardura, lasix, mucinex, humulin NPH, synthroid, Opsumit, Toprol XL, singulair, multivitamin, Revatio, flomax",,"chronic respiratory failure due to pulmonary hypertension, hypothyroidism, right heart failure, chronic kidney disease stage IV, IDDM, BPH, essential hypertension",,NKDA,"['Cardiac failure', 'Cardiogenic shock', 'Chronic respiratory failure', 'Condition aggravated', 'Death', 'Pulmonary hypertension']",2,PFIZER\BIONTECH,IM 1046318,,61.0,F,"body aches, fatigue, low grade temp",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/11/2021,02/11/2021,0.0,UNK,,,,,,"['Fatigue', 'Pain', 'Pyrexia']",2,MODERNA,IM 1046319,FL,33.0,F,2/17 @ 2000- hives on torso and upper body 2/17 @ 2200 shortness of breath 2/18 @ 1100-1400- angioedema (lip and facial swelling),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PVT,,None,Porphyria,,Keflex,"['Angioedema', 'Dyspnoea', 'Urticaria']",2,MODERNA,IM 1046320,NJ,59.0,M,"After1st vaccine severe flatus, after 2nd vaccine chronic diarrhea; loose watery stools q 2hrs with onset 02/15/2021 . No other s/s. No improvement with OTC medicine and diet. Telemedicine appt. pending today with primary care physician.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/01/2021,,PUB,none,none,none,,none,"['Diarrhoea', 'Flatulence']",2,MODERNA,IM 1046321,,19.0,F,"Dizziness, near syncope that resolved immediately when put in supine position",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/15/2021,01/15/2021,0.0,PVT,,,,,,"['Dizziness', 'Presyncope']",1,PFIZER\BIONTECH,IM 1046322,MN,33.0,F,"Missed abortion - received first shot while pregnant (did not know), missed abortion of ~5 weeks gestational age, diagnosed Feb 2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/25/2021,20.0,PVT,,,,,,"['Abortion missed', 'Human chorionic gonadotropin', 'Ultrasound scan']",2,PFIZER\BIONTECH, 1046323,MT,23.0,F,Chills & Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/17/2021,1.0,PVT,,,,,,"['Chills', 'Headache']",2,MODERNA,IM 1046324,TN,79.0,F,"Pt had a little redness below the injection site after the COVID-19 vaccine that came and went. On 2/20/21 (a week after the vaccine) redness was more prevalent and pt had soreness, some swelling, itching, burning sensation, and warm to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/20/2021,8.0,PHM,"Citalopram, estradiol, xanax",,RA,,Sulfa,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 1046325,OH,73.0,F,"fever, chills, swollen lymph nodes in armpit under site of injection, which disappeared after 10 days. Metal smell and taste which lingers.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/09/2021,02/10/2021,1.0,PUB,"Xarelto, aspirin, calcium with D, Preservision vitamins, psyllium, probiotic, cranberry, Estradiol, Atorvastatin",,,,Codeine,"['Chills', 'Dysgeusia', 'Lymphadenopathy', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1046326,TX,,F,Elevated blood pressure 144/93 heart rate 100 Saturation of peripheral oxygen 96 respiration 16 at 4:50pm Benadryl given at 4:55pm BP 138/106 HR 93 SpO2 94 RR 16 at 5:01pm. Patient reports swelling or edema to lip. Reports after injection previous reaction after another unknown injection in previous years. Patient refused transport via EMS advised to go to ER if symptoms worsen.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/21/2021,02/22/2021,1.0,OTH,Unknown,Unknown,Unknown,,Unknown,"['Blood pressure increased', 'Lip swelling', 'Reaction to previous exposure to any vaccine']",1,MODERNA,IM 1046327,PA,83.0,M,"on 15th he had body aches and a temperature(102) and extremely tired and fatigued. went to the ER on 2/20 and took chest xrays and blood work, temp was 98.1, O2 was normal, pulse was normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/15/2021,3.0,PVT,atenolol atorvastatin bethanechol calcium 600 finasteride flecainide Irbesartan Tylenol protonic Tamsulosin,No,Heart out of rhythm high blood pressure,,Latex,"['Body temperature increased', 'Chest X-ray', 'Fatigue', 'Laboratory test', 'Pain']",1,PFIZER\BIONTECH,SYR 1046338,FL,,U,"One patient 14 years old received their first dose of the Moderna vaccine; A spontaneous report was received from a pharmacist concerning a 14-year-old patient who received their first dose of Moderna's COVID-19 vaccine (mRNA-1273) at the age of 14. The patient's medical history was not provided. Concomitant product use was not provided. Between 11 Jan 2021 and 21 Jan 2021 (date not specified), the patient received their first of two planned doses of mRNA-1273 (No Specific Batch numbers provided: 011L20A - 013L20A - 039K20A) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date in Jan-2021 (between 11/Jan/2021 and 21/Jan/2021), at the age of 14, the patient received their first dose of vaccine. Action taken with mRNA-1273 in response to the event was not provided. The event, one patient 14 years old received their first dose of the Moderna vaccine was considered resolved on an unspecified date in Jan-2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273. There were no reported adverse events associated with this case.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-011617: US-MODERNATX, INC.-MOD-2021-011581:",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No Reported Medical History),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1046339,NY,,F,"received the second dose of the vaccine yesterday and a lot of it leaked out; The facility realized this and administered a third dose; Syringe Connection Issue; A spontaneous report was received from a healthcare provider, HCP concerning an unknown age female patient who was administered Moderna Covid-19 Vaccine, the patient was administered second dose of mRNA-1273 Vaccine, but a lot of it leaked out. The facility realized this and administered a third dose. On an unknown date, the patient received first dose of two doses of the Moderna mRNA-1273 vaccine, for prophylaxis of COVID-19 infectious, batch number unknown, date first dose administered unknown. Route unknown. The nurse called on behalf of her friend which in this case was the patient. The patient received the second dose of the vaccine yesterday and a lot of it leaked out. The facility realized this and administered a third dose. The nurse would not disclose the patient's information and shared that she would inform her friend the patient to reported the adverse event. The patient medical history was not provided, no concomitant medications were reported. On 04 Feb 2021, the patient was administered the second dose of mRNA-1273 no batch number unknown for prophylaxis of COVID-19 infectious. Action Taken was to administer a third dose. The event was considered resolved after the third dose was administered.; Reporter's Comments: This report refers to a case of underdose, extra dose administered and device connection issue for mRNA-1273 (lot# not provided) with no associated AEs. Causality of these events is not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Device connection issue', 'Extra dose administered', 'Underdose']",2,MODERNA, 1046340,MA,,M,"A nurse was administering the vaccine when it leaked between the needle and the piston; A nurse was administering the vaccine when it leaked between the needle and the piston; A spontaneous report was received from a healthcare facility staff member concerning a 19 year old, male patient who experienced the vaccine syringe connection issue and vaccine under dose as it leaked between the needle and the piston. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. The patient received their first of two planned doses of mRNA-1273 (batch number not provided) on 06-FEB-2021 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 6FEB2021, he took his son ""Jr."" who has the same first and last name to an vaccination location. He is a dental assistant in the office and a first responder. A nurse was administering the vaccine when it leaked between the needle and the piston. He is unsure how much of the vaccine was administered and how much was lost. The injection was attempted by intramuscular injection to the left deltoid. He has had no symptoms following vaccination and has not taken any treatments. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The event vaccine under dose and syringe connection issues were considered resolved.; Reporter's Comments: This report refers to a case of syringe connection issue and underdose for mRNA-1273 (lot number: not provided) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/06/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Adverse event (No reported medical history),,,"['Device connection issue', 'Underdose']",1,MODERNA,OT 1046341,NM,65.0,M,"Unknown amount of vaccine ran down the back of his arm; A spontaneous report was received from a consumer concerning a 65-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had an unknown amount of vaccine drip down his arm. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter On an unknown date, the patient received their first of two planned doses of mRNA-1273. On 01 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 01 Feb 2021, during administration, some of the vaccine dripped down the back of the patient's arm and onto his pants. The amount of vaccine administered was unknown. Treatment information was not provided/unknown. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The event vaccine dripped down arm was considered resolved on 01 Feb 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # 030L20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Incorrect dose administered'],2,MODERNA,OT 1046342,WA,,F,"Swelling on injection site; Fatigue; Joint pain; Vaccinated subcutaneous instead of intramuscular; A spontaneous report received from a Consumer concerning, unknown age, female patient who received first dose of the Moderna COVID-19 vaccine subcutaneous instead of intramuscular. /MedDRA PT: [Incorrect route of product administration] and experienced swelling on injection site, fatigue, and joint pain. The patient's medical history was not included. Patient's concomitant was not included. On 13 JAN 2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Patient stated she received the Moderna COVID-19 vaccine subcutaneous instead of intramuscular on 13 JAN 2021. Patient stated she experienced swelling on injection site, fatigue, joint pain. Patient stated that the swelling came back in her arm on 21 JAN 2021. c dx Patient stated she was put on antibiotics for treatment. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was unknown/not reported.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot: unknown), reporting Incorrect route of product administration associated with vaccination site swelling, fatigue and arthralgia. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Arthralgia', 'Fatigue', 'Incorrect route of product administration', 'Vaccination site swelling']",1,MODERNA,OT 1046344,MI,79.0,F,"Short of Breath, Spo2 74%",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/30/2021,02/01/2021,2.0,SEN,,,,,,"['Dyspnoea', 'Oxygen saturation decreased']",UNK,MODERNA,IM 1046345,CT,76.0,F,"Pt received vaccine on 2/11/21. She reported onset of redness (approx. 5-6"" diameter) and itching at the site on 2/17/21. She was seen by a dermatologist on 2/19/21 and was diagnosed with cellulitis and started on a five day course of cephalexin. Pt reports redness and itching is resolving and that no further follow up is necessary.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/17/2021,6.0,PUB,,,,,,"['Cellulitis', 'Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 1046346,MI,84.0,F,T. 99.8,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,02/01/2021,2.0,SEN,,,,,,['Body temperature increased'],UNK,MODERNA,IM 1046347,NJ,79.0,M,"When family members came to receive the second dose of their COVID vaccine, they informed us that the above patient had passed away.",Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,,01/20/2021,01/01/2021,,OTH,,,,,,['Death'],1,MODERNA,IM 1046348,FL,66.0,M,"rash ,itching , 5 days after dose prednisone 5 days, Pepcid 5 days, antihistamine shot ,mostly cleared up. received 2nd dose 2-2-21, 7 days later itching restarted, no rash , doctor prescribed same treatment, have some minor itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/10/2021,5.0,PVT,"warfarin 3mg,clopidogrel75mg,atorvastatin40mg,metoprolol25mg,fenofibrate160mg,amloplipine2.5mg,theralith xr",none,"heart disease, bypass",,none known,"['Pruritus', 'Rash']",1,MODERNA,SYR 1046349,VT,98.0,F,"Patient did not feel well and reports general malaise day 2 and day 3 post vaccination. She noticed itching of Right Breast on Day 3 and later that evening, noticed a rash with blisters.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/09/2021,2.0,OTH,"Chlordiazepokide HCL, Colace,Excedrin, Mutlivitamins, Simvastin, Tylenol, Losartan, Hydrochlorthiazide",None,"Diabetes, hypertension. Osteoarthritis, Chronic kidney disease, macular degeneration, moderate persistent asthma",,None,"['Blister', 'Herpes zoster', 'Malaise', 'Pruritus']",1,PFIZER\BIONTECH,IM 1046350,MO,59.0,F,"Fever, aches and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,OTH,None,None,None,,None,"['Fatigue', 'Pain', 'Pyrexia']",2,MODERNA,IM 1046351,,61.0,M,Chilly Nausea weak,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/15/2021,02/17/2021,2.0,PVT,,,,,,"['Asthenia', 'Feeling cold', 'Nausea']",2,PFIZER\BIONTECH,IM 1046352,SC,69.0,M,"dizziness, nausea; took antivert without noticeable effect, recovered in 12 hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/18/2021,2.0,PHM,amlodipine xarelto atorvastatin metoprolol vitamine C,none,controlled HBP atrial fib,,penicillin,"['Dizziness', 'Nausea']",1,MODERNA,IM 1046353,,83.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,SYR 1046354,PA,59.0,F,Itchy rash/small bumps at the site of the injection. Appeared approximately 1 week after initial vaccine injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/20/2021,8.0,PVT,"Crestor 5mg, multivitamin, standardized elderberry extract",none,"high cholesterol, SVT",,no known allergies,"['Injection site reaction', 'Rash pruritic']",UNK,MODERNA, 1046355,MT,48.0,F,"Rash, Fatigue, & Body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/17/2021,1.0,PVT,,,,,,"['Fatigue', 'Pain', 'Rash']",2,MODERNA,IM 1046356,WA,81.0,F,"Rash and itching at injection site, continued for one day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/20/2021,2.0,PVT,"Standard HBP, statin, and thyroid meds",None,HBP,,None,"['Injection site pruritus', 'Injection site rash']",2,PFIZER\BIONTECH,IM 1046357,FL,16.0,F,Age under the requirement for EUA (<18 years of age). No other adverse symptoms noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/01/2021,,PVT,,,,,,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 1046358,TX,63.0,F,papular rash bilateral arms chest and back,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,PVT,"aspirin 81 MG EC tablet atorvastatin (LIPITOR) 40 MG tablet cholecalciferol, vitamin D3, 5,000 unit capsule multivitamin capsule",coronary artery disease,as above,,no known allergies,['Rash papular'],2,PFIZER\BIONTECH,IM 1046359,CO,75.0,F,"I have had every effect listed on the paper of side affect including, difficulty of breathing, fainted, dizzy, nauseous, I have spent days in bed",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,PVT,,,,,"Penicillin,","['Dizziness', 'Dyspnoea', 'Nausea', 'Syncope']",2,MODERNA,SYR 1046360,CA,71.0,F,"Itching, red rash on upper left arm 37 hours after vaccine and still present",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,OTH,"Levothyroxine, amlodopine, hydrochlorothiazide, B12, D3, ONE-A-DAY multivitamins, potassium",None,High blood pressure,,"Sulfa, latex, neosporin, polysporin","['Pruritus', 'Rash erythematous']",1,PFIZER\BIONTECH,SYR 1046361,CO,50.0,F,bursting blood vessels on hand x 2 now. One is R hand finger and now in L hand palm. No reason of injury.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/15/2021,10.0,PVT,Vitamin D,no illness - this is my second vaccine - 1st one was at 01-15-21,"high blood pressure, hypothyroid, shingles",,"amoxcillin, clindamycin, celebrex, lisinopril , cefxil",['Vein rupture'],2,PFIZER\BIONTECH,IM 1046362,NH,47.0,F,"Symptoms onset occurred approx 10 min post administration. Case reports shortness of breath and midsternal chest pain that radiates around her back. She has a history of a cardiac stent one year ago. BP 110/80 HR 80 SpOx 00% room air LS-CTAB Patient evaluated, she presents anxious and admits to anxiety upon arrival. Highly recommended transfer to a higher level of care. Patient refused EMS transport multiple times, she was accompanied by a passenger in the vehicle. She agreed to stay an additional 30 minutes for continued monitoring and then felt well enough to drive home. She was advised to follow up with her PCP and cardiologist.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,OTH,heart meds psych meds,strep throat,microvascular disease Cardiac stent one year ago Mental health-psychiatric,,Latex Demerol Percocet Furonol,"['Anxiety', 'Chest pain', 'Dyspnoea', 'Pain']",2,MODERNA,IM 1046363,NY,39.0,F,Administration error - some vaccine spilled from the needle/syringe. Vaccinator administered a full dose afterwards.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/22/2021,2.0,OTH,,,,,,['Wrong technique in product usage process'],2,MODERNA,IM 1046364,TX,36.0,F,started out with a rash around injection site and is now full blown on left arm from top to wrist and under to arm pit area of arm. rash is a burning sensation and very itchy.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/05/2021,7.0,SEN,,,,,,"['Burning sensation', 'Injection site rash', 'Pruritus', 'Rash']",2,PFIZER\BIONTECH,SYR 1046365,FL,32.0,F,"Day of shot 2/19/21: fatigue, sluggish tired, low grade fever 99.8, nausea, headache. Day #1 after shot 2/20/21: tired, sore, body aches, low grade fever 99.6, nausea, headache. Day #2 after shot 2/21/21: nausea, vomiting, woke up with rash on pelvis, hips and thighs. Severe itching with rash. Day #3 after shot 2/22/21: Hives/rash on lower abdomen, more severe below umbilical area and suprapubic area; rash on bilateral upper anterior thighs, and rash on bilateral hips; severe itching; raised red nodules with circular white base.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/21/2021,2.0,OTH,"Women's One-a-day multivitamin, magnesium, calcium, zinc, vitamin C, biotin",Exploratory Laparoscopic abdominal surgery on 2/11/2021,"anxiety, panic disorder, depression, chronic pelvic pain, chronic back pain",,None,"['Fatigue', 'Headache', 'Nausea', 'Pain', 'Pruritus', 'Pyrexia', 'Rash', 'Swelling', 'Vomiting']",1,MODERNA,IM 1046366,MT,27.0,F,"Chills, Headache, & Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/17/2021,1.0,PVT,,,,,,"['Chills', 'Headache', 'Pyrexia']",2,MODERNA,IM 1046367,OK,51.0,F,About a week later I experienced a large red circular raised itchy rash around the injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/17/2021,8.0,WRK,"Estrogen, Progesterone, Alive 50+ gummy vitamins, Caltrate",None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 1046368,OH,70.0,M,"Started out as very mild itching just above both ankles but below the knees. Starting on Friday, six days after receiving the shot, the itching was a little more aggressive. I started to use over the counter Hydrocortisone .5% level, which helped. The inching is not severe just agitating .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/15/2021,2.0,WRK,Quinapril,none,none,,None,"['Agitation', 'Pruritus']",UNK,PFIZER\BIONTECH, 1046369,OK,72.0,M,Sore arm with redness and swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/21/2021,3.0,PHM,"gabapentin, atorvastatin, Duloxetine, fish oil, carvedilol, tamsulosin, vit E, vit C, lutein",None,High blood pressure,,NKA,"['Erythema', 'Pain in extremity', 'Peripheral swelling']",2,MODERNA,IM 1046370,NY,65.0,F,"Moderna Covid Vaccine, 1st dose. I experienced ""covid arm"" 6-7 days after I received the vaccine. I had itching and developed a 3"" x 2"" oval shaped red area near the site of the vaccine (upper left arm). It is not too bothersome physically, but it does worry me mentally. I also had some left armpit tenderness a couple days after the vaccine, which lasted about 3 days, but that has subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/19/2021,6.0,PUB,25 mg of Sertraline/day multi vitamin/day calcium 600mg/day,none,none,"Shingrix, had uncomfortable flu-like symptoms for approx 24 hours after both doses.",sulfa drugs,"['Axillary pain', 'Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 1046371,KS,68.0,F,"Severe headache, upset stomach, body felt very hot and weakness in legs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,SEN,Alendronate Baclofen Famotidine Losartin Prednisone Antihistamine,None,Ms,,Nitrofuratin,"['Abdominal discomfort', 'Headache', 'Muscular weakness', 'Skin warm']",UNK,MODERNA, 1046372,MI,,F,"AFTER RECEIVING THE SHOT, SHE COMPLAINED OF TASTING THE METALIC TASTE, HER VISION WAS BLURRY, HER FEET WERE HEAVY. ON SITE EMS RESPONDED. SHE SAID SHE FORGOT TO TAKE HER METOPROLOL THIS MORNING (PART OF HER NUMBERS TODAY). SINCE IT HAD BEEN AT LEAST AN HOUR SINCE SHE RECEIVED THE VACCINE AND HER VISION WAS STILL BLURRY, IT WAS RECOMMENDED TO GO TO E.R. FOR FURTHER EVALUATION AND SHE AGREED. EMS TRANSPORTED HER TO THE E.R.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PUB,"METOPROLOL,",,"HAD A STROKE, HAD CANCER",,,"['Blood glucose increased', 'Dysgeusia', 'Limb discomfort', 'Vision blurred']",1,MODERNA,IM 1046373,,82.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Product preparation issue'],2,PFIZER\BIONTECH,IM 1046374,,35.0,M,"Chills, fatigue, body ache",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/10/2021,02/10/2021,0.0,UNK,,,,,,"['Chills', 'Fatigue', 'Pain']",2,MODERNA,IM 1046375,CA,37.0,F,"Redness and swelling radiating from old vaccine scar (either smallpox or TB) located about 2 inches below injection site. First noticed about 26 hours after injection. Redness, swelling, and warmth expanded to about 1.5 inch radius about 62 hours after injection. Second old vaccine scar (either smallpox or TB) located about 2 mm above injection site also turned red but did not radiate. Skin irritation from bandaid adhesive also became red and inflamed. 72 hours after injection and redness, swelling, and warmth improving. No treatment was applied or felt necessary.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,PUB,,,,,,"['Dermatitis', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Skin irritation']",2,MODERNA,IM 1046376,CO,44.0,F,"Immediately after the injection became dizzy, light headed and nauseous. 24 hours later, I developed swelling in my right breast and lymph nodes in my right armpit. It is painful to the touch and swollen to the size larger than a golf ball. Pain radiates down my inner arm to my forearm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,OTH,"Armour thyroid, Lamictal, Humira",none,"Psoriatic arthritis, small fiber neuropathy, interstitial cystitis",,"Latex, shellfish, peanuts, codiene","['Breast swelling', 'Dizziness', 'Immediate post-injection reaction', 'Lymphadenopathy', 'Nausea', 'Pain', 'Pain in extremity', 'Tenderness']",2,PFIZER\BIONTECH,IM 1046377,,85.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046378,FL,70.0,F,At ten days after receiving my vaccine my left upper arm reddened and swelled around the site of injection. There is some pain and the site is very hot to the touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/21/2021,9.0,UNK,,,,,oxycotin,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 1046379,OH,62.0,F,"According to medical information I have Covid 19 Arm. The injection site is red, swollen and very itchy. I also have a few other whelps on other body areas. Same arm higher and lower, midback. It started on Sunday, February 21 upon my waking up. It is still red and whelped up and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,SCH,"Amlodipine 5mg 1/day Women's One A Day Multivitamin Vitamin C 1,000mg Vitamin D3 250mg Calcium 1,200mg","Hypertension, Osteoporosis",,Flu Vaccination about 30 years ago. Have not taken a flu vaccination since.,Dairy Products,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 1046380,,70.0,F,Tachycardia and palpitations. Currently on holter monitor for SVT. Followed up with PCP and did receive 2nd dose without issue.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/15/2021,01/15/2021,0.0,PVT,,Currently on holter monitor for SVT,,,,"['Palpitations', 'Tachycardia']",1,PFIZER\BIONTECH,IM 1046381,FL,79.0,F,"Left arm red, swollen, and itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/18/2021,6.0,PHM,"Lisinopril-HCTZ 10/12.5mg, Synthroid 0.050mg, Multivitamin, Vitamin D 1000UNon",,"Blood Pressure, Thyroid, Cholesterol",,Erythromycin and Sulfa,"['Erythema', 'Peripheral swelling', 'Pruritus']",1,MODERNA,IM 1046382,MI,72.0,F,"Itchy red area measuring approximately 5inches long by 4 inches wide with darker red area in the center approximately 2 inches below injection site. Started 9 days after vaccine. 1st day area was approx 3 inches long by2 inches wide. By evening it had gotten larger, next day more red and itchy and larger. 3rd morning same size but red color is not as bright and no itch.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/20/2021,9.0,PHM,"Fluticasone nasal spray, tolterodine Er caps, sertraline Hal tabs, estradiol patch, calcium citrate +D3 supplement, glucosamine & chondrites complex, curcumin",,,,Levaquin,"['Condition aggravated', 'Injection site erythema', 'Injection site pruritus']",UNK,MODERNA,SC 1046383,FL,16.0,M,Vaccine administered to age < EUA (vaccine given to < 18 year old). No other adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/01/2021,,PVT,,,,,,"['No adverse event', 'Product administered to patient of inappropriate age']",UNK,MODERNA,IM 1046384,MT,25.0,F,"Body aches, Chills & itchy throat",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/17/2021,1.0,PVT,,,,,,"['Chills', 'Pain', 'Throat irritation']",2,MODERNA,IM 1046385,,77.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,SYR 1046386,MI,41.0,F,Patient has general malaise unknown cause . Onsite EMS was called vitals BP 118/64 100% O2 room air HR 72 Patient efused evaluation/care went home against medical advice.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/08/2021,0.0,PUB,,,,,,['Malaise'],1,MODERNA,IM 1046387,CO,66.0,F,Redness and warmth 3 inches below injection site. Began 2/20/21 and has not gone away yet 2/22/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/20/2021,8.0,PHM,"Levothyroxine, probiotic, vitamin D3, turmeric",None,Non allergic rhinitis,,,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,SYR 1046389,PA,77.0,M,Right -side neck pain (injection was given in right arm). Unresolved as of today.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/15/2021,3.0,PVT,,,,,,['Neck pain'],UNK,MODERNA, 1046390,KS,57.0,F,"pt went home 15 min after immunization and then went to drive home and developed throat tightening, she and soa, this happened twice , pt went to the hospital ER for treatment",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,"flonase,multivitamins,proair inhaler,elderberry tablet,vitamin D3,Montelukastbupropion,atorvastatin,omeprazole,estradiol,prednisone, benadryl,zinc and probiotic","asthma, not active at time of vaccine","asthma, GERD,IBS, menopause,arthritis,diverticulosis",,"erythromycin,zithromax",['Throat tightness'],1,MODERNA,IM 1046391,IN,70.0,F,"Woke up in middle of night with fever, chills, teeth rattling, nausea, dizziness, weakness. Took acetaminophen and some anti -nausea drugs I had on hand. Fever left, but returned next night. Weakness, no appetite stayed for two days. Thought it was the flu, but no upper respiratory symptoms. Thought it might be Covid-19 but tested negative. Finally decided it was a reaction to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,02/02/2021,14.0,PVT,10 mg prednisone; calcium with vitamin D ; daily vitamin; .05% clobetasol propionate cream;,passed a kidney stone on day prior to reaction,osteopenia; kidney stones,,allergic to penicillin; unable to take opiates by mouth,"['Asthenia', 'Chills', 'Decreased appetite', 'Dizziness', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 1046392,IL,50.0,F,"That night I started feeling bad, I woke up with a fever of 103 and I took some tylenol. The next day I had fever, chills, nausea and it just continued. Yesterday morning I had my husband take me to ER and I had lost 15 pounds since Wednesday. I couldn't keep down fluids. They tested me for Corona and the flu but both were negative. They also gave me fluids. Everything and smells and tastes terrible. They gave me Zofran but it didn't help. I haven't been able to take my medicine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,OTH,virydd 20 mg daily norco 7.5 up to 4x daily as needed protonix 100 mg 2x daily orphenadrine ER 100 mg 2x daily,No,rheumatoid arthritis 1 kidney depression,,sulfa drugs penicillin Demerol,"['Chills', 'Feeling abnormal', 'Influenza virus test negative', 'Laboratory test', 'Nausea', 'Parosmia', 'Pyrexia', 'SARS-CoV-2 test negative', 'Taste disorder', 'Vomiting', 'Weight decreased']",2,MODERNA,SYR 1046393,NY,20.0,F,Patient reported feeling that her throat felt swollen after receiving dose. Assisted by onsite EMS. Felt better and was released to home from the POD.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/11/2021,02/11/2021,0.0,OTH,,,,,,['Pharyngeal swelling'],1,MODERNA,IM 1046394,WA,22.0,M,"Staff member had hot flash and vertigo upon standing. BP 138/101, P 76, O2 SAT 98%. 5 Minutes later BP 132/87, P 77, O2 SAT 99% Symptoms lasted about 5 minutes and he was able to get up and leave without any further symptoms post 15 minutes after injection per staff member's verbal statement. He was leaving his shift to go home.",Not Reported,,Not Reported,Not Reported,,Not Reported,,12/30/2020,12/30/2020,0.0,OTH,,,,,,"['Hot flush', 'Vertigo']",1,MODERNA,IM 1046395,NY,66.0,F,Slight erythema and pruritus slightly distal to injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/21/2021,2.0,PVT,"Losartan, Lipitor",None,Hypertension and hypercholesterolemia,,None knownNone,"['Injection site erythema', 'Injection site pruritus']",2,MODERNA,IM 1046396,,77.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Extra dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046397,AK,94.0,F,Death,Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,02/20/2021,44.0,SEN,"Morphine, Lorazepam, Haloperidol, Atropine, Citalopram,","Dementia, HTN, Hypothyroid, Intestinal malabsorption, Hx neoplasm, breast,","Dementia, HTN, Hypothyroid, Intestinal malabsorption, Hx neoplasm, breast,",,Lisinopril,['Death'],2,PFIZER\BIONTECH,IM 1046398,OR,46.0,F,"8 days after the vaccine was given, a rash began to form around the injection site. At the time of the injection, a bandaid was not placed over the injection site. due to concern for infection, medical treatment was recommended with hydrocortisone and benadryl creams. As of today, rash is stabilizing, slightly worse",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/21/2021,9.0,PHM,,,,,"penicillin, bees",['Injection site rash'],1,MODERNA,IM 1046399,SD,60.0,M,"2/18/2021 fever 100.5 and scratchy throat 2/20/21-Covid test positive. No contact with covid positive, patient is still admitted in the hospital from December. 2/20/21 patient was drowsy, lung sounds rhonchi, Respirations 36, O2-78 % on room air. 4L per NC applied.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/18/2021,3.0,PVT,"currently hospitalized, multiple meds on board",admitted December 202 for rehab of tibia fracture,"Schizophrenia, Asthma, hypertension",,none,"['COVID-19', 'Pyrexia', 'Rhonchi', 'SARS-CoV-2 test positive', 'Somnolence', 'Throat irritation']",2,MODERNA,IM 1046400,NJ,83.0,F,"With the 1st dose I experienced like a really bad mosquito bite at the injection site. It git red, swollen and very very itchy. About 4 inches round. My PCP recommended me to take Benadryl and it worked. About 24 hours later the symptoms started subsiding.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,Not disclosing,Not disclosing,Not disclosing,,Not disclosing,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 1046401,OR,65.0,F,transient global amnesia,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/14/2021,8.0,UNK,"gabapentin, clonazepam, miralax, citracel, vitamin d,",,"pudendal neuralgia, macular degeneration, anxiety, hypertension,",,,"['Carbon dioxide', 'Full blood count', 'Laboratory test', 'Metabolic function test', 'Transient global amnesia']",2,MODERNA,IM 1046402,KY,42.0,F,"I developed hives, itching from head to toe and throat felt restricted. I went to 2 ER visits was given IV and steroids. The symptoms lasted for 6 weeks.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/05/2021,01/07/2021,2.0,PVT,Dexilant 60 mg,No,Barrs Esophagus?(pre cancer),,"Penicillin, Sulfur, Tree Nuts, Bananas, Shellfish","['Pruritus', 'Throat tightness', 'Urticaria']",1,PFIZER\BIONTECH,IM 1046403,PR,68.0,M,"ABDOMINAL PAIN, PERFORATED BOWEL.",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,01/18/2021,01/23/2021,5.0,PVT,"LISINOPRIL, NIFEDIPINE",NONE,COLITIS,,NONE,"['Abdominal pain', 'Intestinal perforation']",1,PFIZER\BIONTECH,IM 1046404,CA,71.0,F,"Fever, chills, shaking,body aches, headache, dizziness, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,UNK,Carvedilol Calcium/VitaminD candesartan. Zinc Vitamin B12 Furosemide Simvastatin Spironolactone,None,Congestive Heart Failure,,Codeine intolerance,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Pain', 'Pyrexia', 'Tremor']",2,PFIZER\BIONTECH,SYR 1046405,WV,65.0,M,Received 1st dose of Pfizer vaccine on Thursday. Started experiencing left-sided facial droop (eye and mouth) Friday morning. No improvement on Monday morning. Difficulty closing left eye and severe left-sided mouth asymmetry. Patient denies any extremity weakness. Presented to Emergency Department Monday morning for evaluation on 2/22/21. Discharged to home. (Assessment: Bell's Palsy).,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,PUB,"Aspirin 81 mg po every other day, Brilinta 90 mg po 2x daily, Cetirizine 10 mg po daily, Eliquis 5 mg po 2x daily, Lipitor 10 mg po daily, Nitroglycerin 0.4 mg SL prn, Viagra 50 mg po prn.",August 2020: non ST elevation MI,"CAD, hyperlipidemia",,NKA,['Facial paralysis'],1,PFIZER\BIONTECH,IM 1046406,MN,74.0,M,"Was feeling great after the vaccine, felt some tightening in the arm, soreness. Later in the afternoon felt tightness and felt like food poisoning. Significant swelling and harness to the area, chills, nausea and vomiting x2, with fever of 102. Later that evening did take an Aleve. Things settled down and was Saturday before he felt like doing anything and comfortable. He is fine today, just feeling weak, hard swelling at the injection site, but otherwise well. He does occasional gets chills as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,"Omeprazole ER, Levothyroxine, Fluticazone spray, Ezetimibe, daily baby aspirin, Metamucil, advance digestive probiotic.",None.,"Heart blockage, hypothyroidism.",,"Dogs, cats, grass, environmental allergies, medications from anesthesia (? what).","['Asthenia', 'Chills', 'Injection site induration', 'Injection site swelling', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Skin tightness', 'Vomiting']",1,MODERNA,IM 1046407,OK,33.0,F,"My injection site was large and red afterward, but now that I am 12 days out from receiving the vaccine, the injection site looks horrible. It is a large red circle with a dark red rash around the circle.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/15/2021,5.0,WRK,Birth Control,none,none,,none,['Injection site erythema'],1,MODERNA,IM 1046408,CA,48.0,M,1/4/21 given Pfizer; 2/19/21 given Moderna. Still attempting to contact patient for follow up (his voicemail is full).,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,PUB,LORazepam (ATIVAN) 0.5 mg Oral Tab,2/4/21 - R shoulder pain,"ANXIETY 07/11/2019 OVERWEIGHT ADULT, BMI 28-28.9 07/22/2014",,NKDA,['Wrong product administered'],2,MODERNA,IM 1046409,MA,77.0,F,Moderna COVID-19 Vaccine EUA. Rash and itching around injection site (left arm) - went to ED and was diagnosed with cellulitis. She was given a course of antibiotics (IV cefazolin 1 gm x 1 followed by a script for cephalexin 500 mg po QID x 7 days),Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/06/2021,02/15/2021,9.0,PVT,Daughter unsure of med list,None,None,,"Codeine, maybe other allergy","['Cellulitis', 'Injection site pruritus', 'Injection site rash', 'Laboratory test']",1,MODERNA,IM 1046410,IN,30.0,F,"arm looked like cellulitus, bright red, white circle close tot he injection site. puffy and swollen the size of an orange. I iced it and it went away after 4-5 days. it was painful. I took ibuprofen. never spread, just got lighter in color each day and by day 5 it was gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/13/2021,14.0,PVT,NO,NO,NO,,NO,"['Cellulitis', 'Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,SYR 1046411,MT,35.0,F,Body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PVT,,,,,,['Pain'],2,MODERNA,IM 1046412,TX,75.0,F,"16 days round rash, slight sore but no itch",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/11/2021,2.0,OTH,"Cholesterol, Throid, zinc, D3, C, multi vitamin",None,None,Shingles rash,No allergies. Also experienced red rash with Shingles vaccine last year,['Rash'],1,MODERNA,SYR 1046413,TX,85.0,M,"Experienced Primary Diagnosis of Stroke to left rear side of head (Also Mixed Hyperlipidemia, Coronary Artery Disease involving Native Coronary Artery of Native Heart without Angina Pectoris, Type 2 Diabetes)",Not Reported,,Yes,Yes,1.0,Yes,N,02/19/2021,02/19/2021,0.0,PVT,Clopidogrel Bisulfate (Plavix) 75 mg -sp-tc 1 tablet orally/day Glipizide 10 mg 1 tab @ 2/day before meal breakfast and dinner Insulin @25 mg using Lantus Solostar Pen 100 unit/ml 25 units subcutaneous AM & Bedtime long-acting @ 1/day long,"Unexplained respiratory illness of 3 weeks March 2020 Basal Cell carcinoma removed May 2020 TIA - December 2020 - Hospital TIA - January 2021 - blurred vision, speech and delay in response - recuperation at home","Circulatory: Heart Attack diagnosed Aug. 2003 (blocked right coronary artery), 2 blockages cleared and 2 stents installed Dec. 2013. (Stent info found in folder 3/17/17 from hospital indicates ?Resolute 4.0 x 30mm stent across the chronic total occlusion in the mid RCA with excellent angiographic result. A Resolute 2.5 x 18mm stent deploying this across 80% lesion in the mid PDA. StarClose device was deployed with excellent hemostasis.? Hospital 12/20/13 arteriosclerosis per CAT scan 6/19 Digestive: Type 2 Diabetes; Acid Reflux; Endocrine: Low T; Excretory: Small non-obstructive kidney stones, cyst, and undetermined mass per CAT scan 6/19 Muscular/Skeletal: Trigger Finger; occasional shoulder, back, neck, and foot pain; right heel spur & tenderness medial plantar aspect of sole; L2-L3 bulging disc and nerve issues (including sciatic pain in left hip area), and 7/20 arthritis - some fingers and neck Neurological: Possible TIAs 3/17, twice in 8/19, 12/20, and 1/21 ETC: Nonsmoker, drinks wine",,none,"['Angiogram cerebral', 'Blood culture', 'Cerebellar stroke', 'Cerebrovascular accident', 'Computerised tomogram head abnormal', 'Coronary artery disease', 'Echocardiogram', 'Electrocardiogram', 'Glycosylated haemoglobin', 'Lipids', 'Magnetic resonance imaging brain', 'Scan with contrast', 'Type 2 diabetes mellitus', 'Type V hyperlipidaemia']",2,PFIZER\BIONTECH,IM 1046414,KS,65.0,F,"Moderna COVID-19 Vaccine EUA On the eighth day post vaccination, I developed an itchy rash and lump at the vaccination site (left arm). Two days later, the rash is still there but barely visible. Benadryl (topical) stopped the itchiness. The lump is still there. I have no other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/20/2021,8.0,PUB,"Synthroid, 75 mcg",,hypothyroidism,,,"['Injection site mass', 'Injection site rash']",1,MODERNA,IM 1046415,,78.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046416,NY,28.0,U,Patient complained of difficulty breathing after receiving dose. Onsite EMS assisted the patient and transported them to the hospital.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/14/2021,02/14/2021,0.0,OTH,,,,,,['Dyspnoea'],UNK,MODERNA,IM 1046417,MI,29.0,F,Patient felt syncope / fainting unknown cause . Onsite EMS was called vitals BP 100/54 100% O2 room air HR 88 BG 130 Patient refused evaluation/care went home against medical advice.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/08/2021,0.0,PUB,,,,,,['Syncope'],1,MODERNA,IM 1046418,,38.0,M,Dose #1 and Dose #2 administered 23 days apart.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/11/2021,0.0,MIL,,,,,,['Inappropriate schedule of product administration'],2,MODERNA,IM 1046419,CA,75.0,F,TIA 10 days after injection,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/11/2021,10.0,PVT,hydroCHLOROthiazide 12.5 mg capsule Take 0.5 capsules every day by oral route. Prolia 60 mg/mL subcutaneous syringe Inject 1 mL as needed by subcutaneous route as directed for 180 days. sertraline 100 mg tablet TAKE ONE TABLET BY MOUTH,,"COPD, CKD, HTN, hyperlipidemia, GERD, murmer",,"levofloxacin Opioids - Morphine Analogues confusion Penicillins rash, moderate","['Angiogram cerebral normal', 'Arteriogram carotid normal', 'C-reactive protein normal', 'Computerised tomogram head normal', 'Red blood cell sedimentation rate normal', 'Transient ischaemic attack']",1,PFIZER\BIONTECH,IM 1046420,MT,30.0,F,"Fever, Chills, Body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/17/2021,1.0,PVT,,,,,,"['Chills', 'Pain', 'Pyrexia']",2,MODERNA,IM 1046421,,44.0,F,"back pain on 02/13, body aches which intensified at work. symptoms persisted over night with addition of chills/shaking and missed work on 02/14",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/11/2021,02/11/2021,0.0,UNK,,,,,,"['Back pain', 'Chills', 'Impaired work ability', 'Pain']",2,MODERNA,IM 1046422,SC,79.0,F,"After two days, had sore arm, sore shoulder and neck. 4 days after very tired,, and felt like had flu for 5 days. Had rash on left arm ob 6 day, still tired but better. 7 day ok.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/11/2021,2.0,OTH,"Rasagiline Mesylate 1 mg Carbidopa-Levodopa 25-100 tab omeprazole Dr 20 mg Multi vitamins, Fish Oil",,Parkinson's disease Unknown atrophy of Back Arthritis,,None known,"['Arthralgia', 'Fatigue', 'Influenza like illness', 'Neck pain', 'Pain in extremity', 'Rash']",UNK,PFIZER\BIONTECH,IM 1046423,,75.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,SYR 1046424,PA,48.0,F,Diagnosed Bell's Palsy. Facial paralysis.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,OTH,amlodopine 5mg citalopram 20mg pantoprozole 20mg,no,no,,Percocet,['Facial paralysis'],2,MODERNA,IM 1046425,FL,65.0,F,"all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness but hot to touch, periodic cough, runny nose, throat felt like it was closing up, extreme fatigue and body weakness, unable to sleep first night",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,OTH,"zyrtec d, multiple vitamin, B12, Iron, prilosec, probiotic",none,"asthma, allergies, upper respiratory infections, arthritis",,"no food allergies, allergy to dust, mold, pollen, tree, cockroach","['Arthralgia', 'Asthenia', 'Cough', 'Fatigue', 'Headache', 'Insomnia', 'Mobility decreased', 'Pain', 'Pain in extremity', 'Rhinorrhoea', 'Skin warm', 'Throat tightness']",UNK,PFIZER\BIONTECH, 1046426,AR,73.0,F,Hive reaction on injection arm approximately 10-12 cm; very red with itching and stinging,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/20/2021,4.0,UNK,Humira Carvedilol Ramipril HCTZ Paroxetine,,Crohns colitis,,None,"['Erythema', 'Pain', 'Pruritus', 'Urticaria']",2,MODERNA,IM 1046427,NY,45.0,F,PT called the location at 15:45 stating that she had a reaction at 8:00 am which included wheezing and feeling like throat was closing. She took her own Benadryl and utilized her own epi pen on the advice of her own physician. The symptoms subsided when she called.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,OTH,,,,,"Aspirin, Oxycodone, Penicillin, Percocet, Privigen, Simponi","['Throat tightness', 'Wheezing']",2,PFIZER\BIONTECH,IM 1046428,CA,76.0,F,"flushed, feels hot 169/89 80 98.8 F temp 96% SAT #21 Home follow up with pcp",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,,,hx of high Blood Pressure,,codiene,"['Flushing', 'Hot flush']",2,PFIZER\BIONTECH,IM 1046429,OH,54.0,F,"Painful site of vaccine area for 3-4 days. Headache and body aches beginning the evening of the vaccine (Friday 2/12/2021) and still continues. Itching around the mouth the next day(Saturday). Red spots on chin started appearing on (Sunday) the third day. Red painful spots continued to come up on scalp, eyelid, eyebrow, and forehead all on the left side of my head. Finally went to a Clinic (Saturday 2/20/21)and was diagnosed with Shingles. Prescribed Valacyclovir Hcl 1 gram tablet. Was told to contact eye doctor since most of the red areas were around left eye. Also scheduled with family doctor to get something prescribed for nerve pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,PVT,"Rx: Wellbutrein, Lexapro, Levothyroxine, Ambien Supplements: Vit B, Curcumin, Magnesium Malate, Fish oil, Resvaratrol, Vit D",No,Fibromyalgia,,"Seasonal Allergies Sulfa (Penicillin at birth, but I take it now)","['Erythema', 'Facial pain', 'Headache', 'Herpes zoster', 'Neuralgia', 'Oral pruritus', 'Pain', 'Vaccination site pain']",1,MODERNA, 1046430,FL,73.0,F,Severe lower back ache that began the day after the injection. My backache lasted 5 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/14/2021,1.0,PHM,Synthroid,None,Hypothyroid,,"Doxycycline, Sulfa Drugs, Amoxicillin",['Back pain'],1,MODERNA,SYR 1046431,NJ,35.0,F,"I developed a swollen warm lump on my right arm about an inch below the injection site. This occurred two days after I received my second Moderna injection. The pain radiated through the top of arm and in my upper back. It is quite itchy. And the area is very red, in a large oval shape.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/21/2021,2.0,OTH,Pulmicort inhaler,None,Asthma,,Soy and tree nuts,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",2,MODERNA,SYR 1046432,CA,75.0,F,Patient given Pfizer instead of Moderna for her 2nd vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,PVT,,,,,,['Interchange of vaccine products'],2,PFIZER\BIONTECH,IM 1046433,,75.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Product preparation issue'],2,PFIZER\BIONTECH,IM 1046434,NJ,51.0,F,"My period stopped in December 2019, I got covid19 vaccine on 2/19/2021 in the morning and I got my period at night. Not sure it is side effect of vaccine or not.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,Levotyroxine,None,Thyroid,,sulfa,['Uterine haemorrhage'],UNK,MODERNA,SYR 1046435,TX,64.0,F,"site pain headache, nausea, vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/03/2021,1.0,PVT,UNK,UNK,UNK,,UNK,"['Headache', 'Injection site pain', 'Nausea', 'Vomiting']",2,MODERNA,IM 1046436,PA,42.0,F,"gradual onset of mild itching sensation in bilateral ear canals and posterior pharynx along with a tingling tongue sensation after administration of vaccine. No signs of urticaria or respiratory distress (or wheezing). Patient had no other known allergy triggers today, but did have post-nasal drip PTA. Chose to self-administer 0.3mg of epi at 1530 via her own epi-pen which she always carries with her. Post-administration all symptoms resolved, signed a release and left independently",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,PUB,"Advair, Epi Pen, Flomax, Iron Sulfate, Lamictal, Minipress, Seroquel",post-nasal drip at time of vaccination,"Medical hx of: anaphylaxis, anemia, asthma, Bipolar, COPD, GERD, GIB, Htn, obesity, uro-incontinence",,"Avonex, bee sting, NSAID's, Penicillin, Sulfa drugs","['Paraesthesia oral', 'Pruritus']",2,MODERNA,IM 1046437,NE,63.0,M,"same symptoms I had with covid approx 11/4/20: extreme fatigue, night sweats, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/03/2021,1.0,PVT,"Vit D, 81 mg ASA, losartan, actos, januvia, multivit, atorvastatin, escitalopram, metoprolol, celebrex, loratadine, finasteride, androgel",none,"HTN, DMT2, HPL, overweight, low testosterone, depression, SAR, osteoarthritis-knee, male pattern baldness",,None,"['Fatigue', 'Myalgia', 'Night sweats']",1,MODERNA,IM 1046438,IL,31.0,F,"Starting 12 hours after injection fatigue, overall body aches and headache. Starting 12 hours after injection red hot painful welt over the arm. Increased to 3inches by 4 inches after 48 hours. At 48 hours began to itch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,OTH,"levothyroxine, norethindrone",none,hypothyroid,,none,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth', 'Pain']",2,MODERNA,IM 1046439,NJ,88.0,M,"Began to ITCH all over, especially on his head-top and in and around ears. Also, a rash, flat mostly but a few pimply spots on his torso. Torso has this blotchy rash all over from neck to stomach and all over his back. Dr. prescribed a cortisone cream to be applied 2x/day. 2nd Dr prescribed a benedryl cream to slather over his torso. Severe itching and tingling comes and goes.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/17/2021,6.0,SCH,"BREO, TAMSOLUSIN, CRESTOR, 81MG ASPIRIN, NAMENDA, TYLENOL, GINKO BILOBA, GLUCOSAMINE",,ASTHMA,,NONE,"['Paraesthesia', 'Pruritus', 'Rash', 'Rash macular']",2,MODERNA,SYR 1046440,,43.0,F,Dizziness at time of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/19/2021,01/19/2021,0.0,PVT,,,,,,['Dizziness'],2,PFIZER\BIONTECH,IM 1046441,SC,67.0,M,"SUMMARY Two weeks after first vaccine: uncontrollable shaking throughout body, followed by chills, then entire body ache and fever. The first 12 hours were the worst, but after 36 hours all symptoms were gone. DETAIL The Feb 3, 2021 First vaccine - Phizer Feb 18, 2021 5:00 pm suddenly came down with shaking throughout my body and then chills. 6:00 pm shaking subsided 7:00 pm entire body aches from head to feet Later in evening - fever throughout body Feb 19, 2021 feeling better, but still muscle and joint pain throughout body. Some slight fever. No appetite, but can smell chicken broth. February 20, 2021 feeling better but tired 10:00 am COVID test at pharmacy. Noon ate peanut butter and crackers 2:00 pm sat outside for 30 minutes 6:30 pm ate full Mexican dinner February 21, 2021 feeling good with a good appetite. NO SYMPTOMS. 9:30 am breakfast 1:00 pm sat outside for 30 minutes 1:30 pm lunch REFLECTION: During entire time, no difficulty breathing or coughing. And the other symptoms came and went in 36 hours. The symptoms I did have are the same as a bad reaction to the 2nd vaccine. (my muscle aches are not a reaction to the vaccine). Yet, my reaction was not immediate, rather it was 2 weeks and 1 day after my first vaccine. Therefore, do I have COVID, or a bad reaction to my first vaccine? WAITING for COVID test results. Second vaccination is scheduled for upcoming Friday, February 26.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/18/2021,15.0,PVT,Pentoxofylline ER 400 Mg Tab - 1 tablet two times a day by mouth Baby aspirin Zinc B12 Multivitamin DHL Licorice Bacopa,None,Borderline high blood pressure (controlled by a Whole Food Plant Based (WFPB) diet),,Penicillin,"['Arthralgia', 'Chills', 'Decreased appetite', 'Fatigue', 'Myalgia', 'Pain', 'Pyrexia', 'SARS-CoV-2 test', 'Tremor']",1,PFIZER\BIONTECH,SYR 1046442,CA,54.0,F,"fever, severe body pain, severe headache, dizziness, nausea, night sweats, fatigue lasting for 28 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PHM,"progesterone, estradiol, Singulair, hydroxyzine",none,Hairy Cell Leukemia,,Sulfas,"['Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Night sweats', 'Pain', 'Pyrexia']",2,MODERNA,SYR 1046443,,32.0,M,"chills, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/18/2021,0.0,UNK,,,,,,"['Chills', 'Headache']",2,MODERNA,IM 1046444,,76.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046445,CA,58.0,F,Aches nausea tired headache diarrhea vomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/15/2021,02/15/2021,0.0,UNK,,,,,,"['Diarrhoea', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Vomiting']",2,MODERNA,SYR 1046446,UT,55.0,F,"1/12/21 first vaccine dose. Delayed reaction. Similar to a weak reaction to allergy shot. no issues 2/16/21 second vaccine dose. 7am: vaccine administered. Could feel in muscle 8-9am: could feel swelling deep in muscle. No visible swelling at shot site. 9-12noon: could feel vaccine swelling / pain radiate down the arm to the elbow and below 3:00 - 4:30 pm start feeling neck and buttock pain 6:00 pm - neck and buttock pain becomes more pronounced. 8:00 pm - ibuprofen taken 200 mg 4 tablets 2/17/21 4:45 am pain spread throught body 5:30 am pronounced muscle, joint pain 5:45 am ibuprofen taken 200 mg 4 tablets sleep 11:00 am continued deep muscle and joint pain 11:00 am naproxen liquid gel 220 mg 3 capsules sleep 5:00 pm some reduction in pain 8:00-9:00 pm Full On Body Rash 8:00 pm ibuprofen 200 mg 3 tablets sleep 2/18/21 5:00 am still have full on body rash. pain reduced 7:00 am arrive to work. Fatigue. 4:00 pm leave work. Nausea. 5:00 pm Home. Nausea. vomiting. Take Nauzene 2/19/21 Itchiness begins. Benadryl Taken. Body Rash fading 2/20/21 symptoms begin to subside 2/21/21 itchiness resumes. Very Annoying. Change of clothes finds pustules all over abdomen and back. broken pustules likely from scratching",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/16/2021,0.0,OTH,bi-weekly allergy shots lexapro proponal citirizine montekulast famitidine benadryl fish oil digestive enzyme zinc biotin vitamin k,January - February: sinus infection January - possible severe gastroenteritis,Allergies / Bi-Weekly Allergy Shots,,"sulfa medications old anti seizure medications - dilantin; tegretol; phenobarbital anything outside ie grass, trees, etc","['Arthralgia', 'Fatigue', 'Injection site swelling', 'Musculoskeletal pain', 'Myalgia', 'Nausea', 'Neck pain', 'Pain', 'Pruritus', 'Rash', 'Vomiting']",2,MODERNA,IM 1046447,NM,38.0,F,"2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM",Yes,02/18/2021,Not Reported,Yes,1.0,Not Reported,N,02/12/2021,02/13/2021,1.0,PVT,"Vitamin D3 2000 U daily, Calcium carbonate 500 mg daily, Cyanocobalamin/folic acid/pyridoxine 200mcg-500 mcg-5mg daily, Vitamin B12 1000 mcg daily, Echinacea 450 mg twice daily, St. John's Wort 300 mg daily, Fish oil 1000mg daily, Vitamin","1/17/2021 Fell while drunk, right distal humerus fracture, right facial bruising","Metabolic disorder, anemia",,Penicillin,"['Activated partial thromboplastin time prolonged', 'Alanine aminotransferase increased', 'Anaemia', 'Anion gap', 'Asthenia', 'Blood albumin decreased', 'Blood alkaline phosphatase increased', 'Blood bilirubin increased', 'Blood creatinine increased', 'Blood culture positive', 'Blood fibrinogen decreased', 'Blood lactic acid', 'Blood magnesium increased', 'Blood urea increased', 'Carbon dioxide decreased', 'Chest X-ray abnormal', 'Culture', 'Culture urine positive', 'Death', 'Escherichia test positive', 'Haematocrit decreased', 'Haemoglobin decreased', 'Hypotension', 'International normalised ratio increased', 'Loss of consciousness', 'Mental status changes', 'Mouth ulceration', 'Pancytopenia', 'Platelet count decreased', 'Pleural effusion', 'Pneumonia', 'Prothrombin time prolonged', 'Rectal haemorrhage', 'Red blood cell count decreased', 'Respiratory failure', 'SARS-CoV-2 test negative', 'Sepsis', 'Urinary tract infection', 'Urine analysis normal', 'White blood cell count decreased']",2,PFIZER\BIONTECH,IM 1046448,NY,74.0,F,"02/12/2021- 9 PM -Left arm felt great pain at injection site, Midnight- great pain again, chills, fever, no balance-dizziness, walking into walls, dresser. 02/13/2021-Exhausted, sleeping all day, cold-wrapped in blankets, headaches 02/14/2021- finally sitting up, starting to move around 02/15/2021- starting to recover to normalcy",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,PHM,"Amlodipine Besylate, Atorvastatin, Montelukast, Q-Var Inhaler, Meclizine-( as necessary) CVS Women's Daily Multivitamin ,Glucosamine Chondroitin w/MSM, Biotin",None,"Arthritis, Evergreen Allergies",,Allergies to Evergreens,"['Balance disorder', 'Chills', 'Dizziness', 'Fatigue', 'Feeling cold', 'Headache', 'Hypersomnia', 'Injection site pain', 'Pyrexia']",1,MODERNA,IM 1046449,CA,48.0,F,"I started feelin strong COVID Symptoms like when I was sick, head and neck pain, chills, joint and body pain, weakness, body heaviness lasted for 2 days. A week after, I had minimal physical exercise with my upper body and had a very strong pain on my right thigh, like muscle pain but stronger with some burning sensation just in the upper part then it turn into a rheumatism like pain with no strength, next day the left thigh same thing, by Friday the pain in my thighs was less but went up to my hips and was a kind of pain and numbness and still difficulty to walk, by Saturday I got better, pain and legs weakness almost gone. I have exercised years, and I know what is a muscle pain when returning to work out. I don't even use my legs and this pain way different and stronger. I had covid on December, started with symptom's on 12/15/2020",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,02/11/2021,1.0,WRK,,none,none,,Vicodin,"['Arthralgia', 'Asthenia', 'Burning sensation', 'Chills', 'Discomfort', 'Gait disturbance', 'Headache', 'Hypoaesthesia', 'Muscular weakness', 'Myalgia', 'Neck pain', 'Pain', 'Pain in extremity']",UNK,MODERNA,IM 1046450,,61.0,F,"chills, temp 100.7, body aches, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/18/2021,0.0,UNK,,,,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",2,MODERNA,IM 1046451,MA,44.0,F,"Nausea, dizziness, headache, fever of 102, chills, fatique",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/10/2021,02/10/2021,0.0,PUB,vitamin D,none,lymphedema,,none,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia']",2,MODERNA,SYR 1046452,,77.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046453,MI,38.0,F,Patient had respiratory distress unknown cause . Onsite EMS was called vitals BP 111/74 100% O2 room air HR 78 BG 97 Patient refused evaluation/care went home against medical advice.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/08/2021,0.0,PUB,,,,,,['Respiratory distress'],1,MODERNA,IM 1046454,IN,73.0,M,"Fever of 101, uncontrolled shaking, headache,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,WRK,"Advair, Atorvastatin, calcium, B12, Omeprazole, Aspirin (162mg), Fish oil, Probiotic, Areds 2 with multi vitamin",none,"Asthma,",,iodine,"['Headache', 'Pyrexia', 'Tremor']",1,MODERNA,IM 1046455,MT,23.0,F,Fever & Body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/17/2021,1.0,PVT,,,,,,"['Pain', 'Pyrexia']",2,MODERNA,IM 1046456,MD,85.0,F,Moderna COVID-19 Vaccine: Pt received 2nd dose 22 days after 1st Moderna dose (1/29/21). Pt not registered at time of 2nd dose and computer system was not working. Pt spouse also received 2nd dose but his was 26 days from 1st Moderna dose (1/25/21),Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,,,PVT,,,,,,['Inappropriate schedule of product administration'],2,MODERNA,IM 1046457,OH,43.0,F,On 2/20/21 when I woke up I went to use the restroom. When I wiped I noticed that I was spotting on the tissue. This happened a second time and then it was finished. I felt really tired and not myself. Then later that night my arm began to hurt so bad that I could not lift it. I began to rub the area that was hurting and noticed that I now had a nice size lump there . I took a Tylenol 500mg and a hot shower. When I woke up the next morning my arm was still hurting but not as bad. When I went to use the bathroom I had began to start spotting again. This continued throughout the day and now I am bleeding as if I was having my period. I am super tired. It is to the point that i cant function at work.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,UNK,"Tylenol, Jamaican sea moss.",None,None,,KNA,"['Fatigue', 'Feeling abnormal', 'Impaired work ability', 'Joint range of motion decreased', 'Limb mass', 'Pain in extremity', 'Vaginal haemorrhage']",2,PFIZER\BIONTECH,IM 1046458,CO,70.0,F,"27 hours after injection I began to feel a migraine, chills, incredibly tired and my temperature went up to 100.8. My chest was tight and achy and my oxygen levels stayed at about 88. I slept about 10 hours and woke up feeling fine. My chest is sore and achy but better than yesterday.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/21/2021,1.0,OTH,"Symbicort, Incruise Ellipta, Rosuvastatin, Levothyroxine, Paroxetine, Flonase",none,"COPD, Chronic Fatigue Syndrome",,nickle in jewlery,"['Body temperature increased', 'Chest discomfort', 'Chest pain', 'Chills', 'Fatigue', 'Migraine']",2,PFIZER\BIONTECH,IM 1046459,,56.0,F,"Pt received injection, first dose. of Pfizer vaccine at 10:27am. Pt was taken to observation station in mall area of hospital for 15 minute observation, by another nurse.. At approx. 10:32, when observing nurse questioned pt about any headache, nausea, vomiting or other reactions, , pt c/o headache, then dizziness, nausea and ultimately started attempting to vomit, having ""dry heaves"" only. This nurse calls Code RRT to location of event.. Pt was taken to ER via stretcher.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,PVT,,,,,,"['Dizziness', 'Headache', 'Nausea', 'Retching']",1,PFIZER\BIONTECH,IM 1046460,OH,79.0,M,"Patient states since he got the first dose of Pfizer vaccine on 2/3 and the second on 2/17. He has gained almost 20 pounds since taking the first shot. Patient states he has gained right around 20 pounds since getting the first shot of the Pfizer vaccine. States he had some shortness of breath right after receiving the first dose of vaccine, but that has cleared. Felt achy and stiff and sore after the second injection. Follow up with patient on 2/20/21 F/U with caller - He was advised at ER that he had excessive fluid retention; no other issues were identified. He was advised to increase his furosemide dose from 20mg twice daily to 40mg twice daily for 5 days. He continues to feel tired and weak, with slight shortness of breath. Confirmed with caller that his 2 vaccinations were separated by only 14 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/03/2021,0.0,PUB,"Furosemide 20mg BID lisinopril 40mg QA , Xarelto 20mg QD metformin 250mg QD Sotalol 80mg BID Simvastatin 40mg QD Ibuprofen 200mg 4 times daily since second shot",,"A-fib, retaining fluids(furosemide) Hypertension ( controlled with lisinopril) diabetes (metformin) Pacemaker and defibrilator",,,"['Asthenia', 'Condition aggravated', 'Dyspnoea', 'Fatigue', 'Fluid retention', 'Inappropriate schedule of product administration', 'Musculoskeletal stiffness', 'Pain', 'Weight increased']",1,PFIZER\BIONTECH,IM 1046461,,54.0,F,"1100 patient sitting in recovery. states she feels ""funky"". Declined w/c and stated she really needed to use the restroom. Patient ambulated without difficulty, gait steady and nurse accompanied to restroom. Patient describes a strange tingling type of sensation in left arm and face that has progressed all over head. Pt. voided and ambulated accompanied to private observation area. 1105 BP 149/93; HR 97; O2 sat 99% on room air. EMT in attendance. 1108 Patient moved to outside and mask removed due to feelings of anxiety over the ""strange sensations"" Encouraged to deep breath. Offered patient ambulance transport. Patient declined. 1116 Patient BP 128/81; HR 94; O2 97%. Husband with patient, patient signed declination of ambulance transport, left with husband to personal vehicle. gait steady.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,"Valsartan, ASA 81 mg, vitamins",none,HTN,,"Penicillin, latex",['Feeling abnormal'],2,MODERNA,IM 1046462,,80.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Product preparation issue'],2,PFIZER\BIONTECH,IM 1046463,CA,59.0,F,chills body aches fever last for 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,UNK,,,,,,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1046464,NE,89.0,M,"Patient stated he felt ""funny in the head"" on 02/19/2021 at 4:00 pm. His wife stated that the patient had seemed confused. Gave patient 2L of fluids and discontinued trazodone. Patient returned to baseline and was discharged after 24 hours.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/18/2021,02/19/2021,1.0,UNK,"acetaminophen, alprazolam,amlodipine, aspirin, atorvastatin, escitalopram, levothyroxine, losartan, meclizine, meloxicam, pantoprazole, tamsulosin, vitamin D3",,"hypertension, GERD, Vitamin D Deficiency, BPH, arthritis, hyperthyroidism, anxiety, history of mild cognitive impairment, metabolic encephalopathy, aseptic meningitis",,Sulfa (sulfonamide antibiotics),"['Blood creatinine increased', 'Confusional state', 'Electrolyte imbalance', 'Feeling abnormal', 'Head discomfort', 'Urine analysis normal']",2,MODERNA,IM 1046465,VA,72.0,F,Racing heart 40 minutes after vaccination Large redness and itching where the vaccine was done on left arm 2.5 days after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/22/2021,3.0,PHM,"nasonax nose spray daily, claritin daily, lipitor 2x week, metoprol tar 25 mg",none,"mitral valve prolapse (diagnosed at age 26), periodic heart racing or pausing when overly tired mentally, too much caffeine or small amount of alcohol. Metoprol prescribed for the above reason.","Flu vaccine strong one for over 65 year olds in 2016 , 36 hours after had severe dizziness, nausea which lasted for 10 hours.","penicillin (was told as a child), seasonal allergies hay fever, sinus congestion ongoing","['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 1046466,,64.0,F,"Chills, body aches for 10 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/16/2021,02/16/2021,0.0,UNK,,,,,,"['Chills', 'Pain']",2,MODERNA,IM 1046467,,71.0,F,Pt reports that she got severe vertigo starting 1d after vaccination which last for 1w then spontaneously resolved. Pt reported this when she presented for 2nd dose and she requested that I write a VAERs report.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/01/2021,01/01/2021,0.0,UNK,,,,,,['Vertigo'],UNK,MODERNA, 1046468,FL,67.0,F,Full body aches Insomnia Headache Difficulty concentrating Temp low,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/13/2021,1.0,UNK,Fluoxetine. 60 mg Alprazalom. .5 mg at bedtime Bupropion XL 300mg Omeprazole. 40 mg Trelegy Elipta 100/62.6/25 Pro air HFA. As needed Lutein. 20 mg,Anxiety/Depression,Anxiety/Depression COPD Osteopenia in hips Bicuspid Aortic Valve GERD,,None,"['Body temperature decreased', 'Disturbance in attention', 'Headache', 'Insomnia', 'Pain']",2,PFIZER\BIONTECH,IM 1046469,,72.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,SC 1046470,WA,39.0,M,Staff member reported being sick and in bed for 3 days. Staff member also noted 'sporadic nose bleeds'.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/04/2021,02/04/2021,0.0,OTH,,,,,,"['Epistaxis', 'Illness']",2,MODERNA,IM 1046471,NJ,83.0,F,"With the second dose I experienced itching and what it feels like a swollen mass on my left arm. I could push it and it would move around my arm. Like a little ball. It was hot to the touch. I also developed cellulitis on my left arm but not at the injection site, lower (medium anterior lateral part of my left arm). I decided to go to the ER to get it checked and they told me it was cellulitis. They prescribed me Augmentin and it did the trick, 48 hrs after starting the Augmentin it was much better and now it is all gone. The little moveable lump in my arm is much smaller but I can still feel it if I press it.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/30/2021,2.0,PVT,Not disclosing,Not disclosing,Not disclosing,,Not disclosing,"['Cellulitis', 'Limb mass', 'Pruritus', 'Skin warm']",2,MODERNA,SYR 1046472,MT,59.0,F,"Headache, Body ache, Nausea, & Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/17/2021,1.0,PVT,,,,,,"['Headache', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,IM 1046473,MN,61.0,M,"2/20/21-61 year old male with decreased level of consciousness and hypoxia. I received a call from nursing staff indicating that patient was having low oxygen saturations this AM and required oxygen. He needed only 1.5-2L by NC but was mouth breathing so mask was used and 4L due to mask. This brought his saturations back up. He has been quite drowsy since receiving his second COVID vaccine on 2/17/21 and has not been eating and drinking much. Today he is not responding to nursing staff in a coherent fashion. I met with him in his room along, RN. He did not wake to my voice or touch. On examination he is sleeping and using accessory muscles to breath, especially his abdomen. NC/AT, face symmetric. Lungs are clear to auscultation bilaterally anteriorly with no wheeze heard. No pretibial edema. 61 year old male with decreased level of consciousness. I will send patient to the ER due to his decreased level of consciousness and difficulty with breathing causing accessory muscle use despite normal respiratory rate of 17 but with hypoxia. I do believe his fever of 103 this AM was due to the COVID vaccine. I am concerned that he could be having a COPD exacerbation on top COVID vaccine symptoms and his bladder cancer is dragging him down along with dehydration from poor intake the past few days. I did call and speak with the ER provider and the EMS crew. They reported seeing a lot of this with the second COVID vaccine. 2/21/21-I received a call from nursing staff indicating that patient had worsening hypoxia with need for 8L of oxygen by mask. He was very restless and not making a lot of sense. He had receive Tylenol PR for a fever of 103 that was now only down to 101 and not budging. He was in the ER yesterday and diagnosed with possible Right middle lobe pneumonia on CT. He is already taking Levaquin. Due to his Oxygen need I did call to see about possible direct admission as he had a full work up the day before. The hospitalist was concerned that he might need BiPAP and so I did call and speak with the ER provider and she agreed that due to his new oxygen requirements he should be sent to the ER there and likely would need ICU. She was advised of the work up from yesterday so as not to repeat what wasn't needed. He was sent by ambulance due to his inability to sit up well. I received a call later that night from the intensivist in the ICU indicating that patient was reacting to the COVID vaccine most likely. He felt that there really was not much in the way of a pneumonia diagnosis as that has really not shown up on their imaging and all labs are normal including white count, CMP and blood gases. He is still requiring oxygen and is able to answer in sentences but is very drowsy and may be a bit confused. He has a minimal UTI and they will keep him given his low level of consciousness and hypoxia.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/17/2021,02/18/2021,1.0,PVT,"ASPIRIN, 81 MG TABLET, ENTERIC COATED, ORAL, 81 MG EVERY NIGHT AT BEDTIME , Preventative Medicine ATORVASTATIN, 10 MG TABLET, ORAL, 10 MG EVERY NIGHT AT BEDTIME , Hyperlipidemia BISACODYL, 5 MG TABLET, ENTERIC COATED, ORAL, 5 MG TWO TIMES A",Urinary Tract Infection,"Actinic keratosis, Acute respiratory failure with hypoxia, Adverse effect of benzodiazepines, initial encounter, Alcohol abuse, in remission, Anemia, unspecified, Atopic dermatitis, unspecified, Benign prostatic hyperplasia with lower urinary tract symp, Chronic obstructive pulmonary disease, unspecified, Dermatitis, unspecified, Epilepsy, unsp, not intractable, without status epilepticus, Frequency of micturition, Gastro-esophageal reflux disease without esophagitis, Hematuria, unspecified, Hyperlipidemia, unspecified, Long term (current) use of aspirin, Long term (current) use of oral hypoglycemic drugs, Major depressive disorder, single episode, unspecified, Malignant neoplasm of bladder, unspecified, Nicotine dependence, cigarettes, uncomplicated, Obesity, unspecified, Obstructive sleep apnea (adult) (pediatric), Other fatigue, Peripheral vascular disease, unspecified, Pneumonia, unspecified organism, Radiculopathy, lumbar region, Schizophrenia, unspecified, Type 2 diabetes mellitus with diabetic neuropathy, unsp, Unsp intracranial injury w/o loss of consciousness, sequela, Unsp symptoms and signs w cognitive functions and awareness, Unspecified urinary incontinence",,"FLUPHENAZINE, NICKEL","['Accessory muscle', 'Aphasia', 'Appetite disorder', 'Bladder cancer', 'Blood gases normal', 'Computerised tomogram thorax normal', 'Condition aggravated', 'Confusional state', 'Decreased appetite', 'Dehydration', 'Depressed level of consciousness', 'Dyspnoea', 'Fluid intake reduced', 'Gait inability', 'Hypoxia', 'Incoherent', 'Intensive care', 'Laboratory test normal', 'Metabolic function test', 'Mobility decreased', 'Mouth breathing', 'Oxygen saturation decreased', 'Pyrexia', 'Restlessness', 'Somnolence', 'Unresponsive to stimuli', 'Urinary tract infection', 'White blood cell count normal']",2,MODERNA,IM 1046474,MO,76.0,F,Patient said the day of the vaccination she developed a red patch about 1/2 inch in diameter that was red and swollen and a little tender. Patient reported that it was periodically itchy and she has been scratching it. She stated that yesterday (day 9 after vaccination) that she noticed the size of the redness had increased. She said it was still periodically itchy and only slightly tender to the touch. She said she felt otherwise fine no systemic effects reported. Patient had not taken anything. Recommended benadryl and icing the area. Treatment outcome unknown at this time.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,PHM,unknown,unknown,heart disorder,,no known allergies,"['Erythema', 'Pruritus', 'Swelling', 'Tenderness']",1,MODERNA,IM 1046475,,46.0,F,"Low grade temp, body aches, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/11/2021,02/11/2021,0.0,UNK,,,,,,"['Chills', 'Pain', 'Pyrexia']",2,MODERNA,IM 1046476,OH,68.0,F,"I had no symptoms for the first 48 hours. On days 3-6 I was fatigued but not enough to effect daily living activities. Day 6 ( Feb 18, 2021) I started to have a lot of muscular aches and the injection site started to get red and swollen. I had fever and chills from the 18th through the 20th as well as a swollen arm and a lot of redness in the arm and minor itching. The red area on my arm was a patch about 4 inches wide and 6 inches long. The swelling was confined to the injection site and was raised up in a circle about 2 inches in diameter. My fever during this time was at 99 degrees. Today is Feb 22 and most of my symptoms are gone, just minor redness and itching at injection site. I was just surprised that my symptoms didn?t show up until about 6 days after the vaccination.. Everything I have read suggested they could appear within 48 hours of the injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/18/2021,6.0,PVT,L-THYROXINE 50mcg 1 x day LISINOPRIL. HCTZ/20-25 mg. 1x day ATORVASTATIN 10mg 1x day CEQUA 0.09% solution for dry eye 2 x day COSOPT Pf 2%-0.5% solution for dry eye 2x day Vitamin D 1000 IU per day Baby Aspirin 81mg per day Multi vitamin 1,None,Arthritis - minor in hands and knees,,Allergic to Celebrex,"['Chills', 'Erythema', 'Fatigue', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Myalgia', 'Pyrexia']",1,MODERNA,SYR 1046477,,87.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046478,NH,72.0,F,"Patient received vaccine at 10:23 am and parked and instructed to wait 30 min due to prior reaction to bee stings. At 10:47am patient reported feeling a flushed and reddened face, ""blurry eyes"", and lightheadedness. Assessment VS as follows BP 150/70 HR 70 - SR skin- warm and dry SpOx-99 % This reaction was not like a typical bee string reaction. She denies restricted airway and throat tightness. Talking in a normal rate and rhythm. Advised patient that we will call EMS for transport to a higher level of care, however patient refused. This patient was instructed to remain onsite for further observation and she agreed. She was accompanied by her spouse who was the driver. She reported that she will return home and take benadryl or the epi-pen if condition worsens. She will contact her doctor and report her experience today. Patient felt recovered and decided to leave after 30 additional minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,UNK,meds for hypertension Has an epi-pen and Benadryl at home for bee stings.,none,hypertension,,Bee stings,"['Dizziness', 'Erythema', 'Flushing', 'Vision blurred']",1,PFIZER\BIONTECH,IM 1046479,CA,72.0,F,Pt states that approx 4 hours after the injection she had her glands in her neck start swelling and her throat became very itchy. She took 2 benadryl and it started to get better after about 20 minutes.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,PVT,,,,,"Sulfa, Pcn, food allergies","['Swelling', 'Throat irritation']",1,MODERNA,IM 1046480,NY,80.0,F,"itching of the skin in the neck area. Lightheaded. Ambulated with staff to the medical area. Given water and Benadryl 50 mg po. Rested lying down for 15 minutes, felt much better and declined to receive further medical care. Husband with her and driving her home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,OTH,Methimazole,none,hyperthyroidism,,IV dye,"['Dizziness', 'Pruritus']",UNK,PFIZER\BIONTECH,IM 1046481,FL,29.0,F,"Fatigue, cold sweat/chills, slight headache, muscle/joint pain, skin painful to the touch (typically occurs to me right before getting a fever or becoming sick)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,OTH,None,UTI,None,,None,"['Arthralgia', 'Chills', 'Cold sweat', 'Fatigue', 'Headache', 'Myalgia', 'Tenderness']",2,PFIZER\BIONTECH,SYR 1046482,MT,20.0,F,"Body aches, Chills, Headache, Injection site pain",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/17/2021,1.0,PVT,,,,,,"['Chills', 'Headache', 'Injection site pain', 'Pain']",2,MODERNA,IM 1046483,KY,29.0,F,"She developed flu like symptoms the day after receiving the vaccine, including, fever, chills, nausea, vomiting, fatigue, myalgias, rash, which have persisted for 6 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/16/2021,1.0,OTH,unknown,none,none,,reglan,"['Chills', 'Fatigue', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza like illness', 'Influenza virus test negative', 'Myalgia', 'Nausea', 'Pyrexia', 'Rash', 'SARS-CoV-2 test negative', 'Vomiting']",2,PFIZER\BIONTECH,UN 1046484,,75.0,F,Email.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Unevaluable event'],2,PFIZER\BIONTECH,IM 1046485,NY,74.0,F,"side effects started about 8 pm in the evening , my skin started to itch like crazy and broke out in hives all over my body but not on my face. The next morning i woke up and saw a dermatologist who said if sounded like it was from the injection. prescribed Allegra once a day and Benadryl 4 times a day. the next morning, my bottom lip was swollen. then my face broke out in hives in the evening and with i would wake up it was gone but i did have two puff pockets under my eyes. i called my primary care Dr. My Dr prescribed me the epi pen just incase she needed it. Friday i also had chills By Saturday i stated to improve. I was taking antihistamine and Benadryl together. By Sunday i started to take less of the Benadryl and by Monday i has stopped al together.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/10/2021,2.0,OTH,"levothyroxine, losartan potassium 100 mg , amlodipine besylote 10 mg, Crestor 10 mg, previside, Ventolin HSA inhaler, Align, Biotin, Symbiotic claustrum plus",,,,,"['Chills', 'Lip swelling', 'Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,SYR 1046486,,23.0,F,"SOB, fatigue, fever of 101.1, sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/18/2021,0.0,UNK,,,,,,"['Dyspnoea', 'Fatigue', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 1046488,IN,86.0,F,"Modern vaccine rec'd 1/27, about 3-4 days later she started itching across her shoulders. It was itching really bad and there were small bumps and she was red from one shoulder to the other. I applied a itching cream and it only lasted a couple hours so we tried many different creams but nothing seem to stop the itch. The rash is from her shoulders to her neck line and from nick to waist line and it itches tremendously. The NP stated it was Shingles and she was prescribed meds and took them for 10 days and it cleared up for a few days. today it's broken out again and its itching. She's scheduled to get the 2nd dose and don't know if she should get the next dose",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/30/2021,3.0,PUB,Yes prescriptions with morning breakfast but cannot locate them at the moment,No,No,,No,"['Erythema', 'Herpes zoster', 'Pruritus', 'Rash']",1,MODERNA,IM 1046489,AZ,75.0,F,Rash appeared on arm around and below vaccination sport about 11-12 days later. Started to disappear as of date of report,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/05/2021,02/11/2021,6.0,UNK,,,,,,['Vaccination site rash'],UNK,MODERNA, 1046490,IN,83.0,F,"arm pain, diarrhea, headache, no appetite within 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PUB,,"arthritis, diabetes, kidneys, high blood pressure, high cholesterol","arthritis, diabetes, kidneys, high blood pressure, high cholesterol",,,"['Decreased appetite', 'Diarrhoea', 'Headache', 'Pain in extremity']",2,MODERNA,IM 1046491,MA,87.0,M,Severe diarrhea.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PUB,"Numerous : Lisinopril, Zyrtec,, Meloxicam, Omepresol, Simvastatin, Metformin, Glipizide, Levothyroxin, Spironolactone, Baby Aspirin, Gabapentin, Probiotic, Lutein, Multi Vitamin, Vita e, Cod Liver oil pill, Vitamin B complex C, Glucosamine,",None,"Diabetes, pacemaker implant",,Tree pollen,['Diarrhoea'],UNK,MODERNA, 1046492,MI,65.0,F,"Patient had an allergic reaction . Onsite EMS was called vitals BP 154/56 97% O2 room air HR 58 Patient treated, released home against medcial advice.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,PUB,Diphenhydramine,,,,"Allergy status to other drugs, medicaments and biological subs","['Blood pressure increased', 'Hypersensitivity']",1,MODERNA,IM 1046493,MT,30.0,F,"Headache, Fever, Chills, & Sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/17/2021,1.0,PVT,,,,,,"['Chills', 'Headache', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 1046494,,53.0,M,"Sore arm, fever, body ache, and fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/25/2021,02/25/2021,31.0,UNK,,,,,,"['Fatigue', 'Pain', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 1046495,WA,39.0,M,Staff member described being ill and in bed for 3 days and also described having 'sporadic nose bleeds' during this time. No further information reported and staff member has returned to work.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/04/2021,02/04/2021,0.0,OTH,,,,,,"['Epistaxis', 'Illness']",2,MODERNA,IM 1046496,WA,54.0,F,"This was my first vaccine... almost immediately I had a headache and my blood pressure went up. I stayed for 45 minutes after my vaccine due to my blood pressure was high. I also felt a little fuzzy. About an hour later I got nauseous, had chills and felt very fatigued. The next morning when I woke up, my left eye was crusted over. I did not think anything of it until I got the second vaccine and it crusted over with it as well. I was very fatigued for 2 1/2 days. Arm was a little sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,OTH,Welbutrin and multi vitamins,none,none,"23 and 24 years ago, the flu vaccine made me VERY sick. I am now exempt from receiving it.","Most pain meds, flu vaccine and sensitivity to many medications","['Blood pressure increased', 'Chills', 'Eyelid margin crusting', 'Fatigue', 'Feeling abnormal', 'Headache', 'Immediate post-injection reaction', 'Nausea', 'Pain in extremity']",UNK,PFIZER\BIONTECH,IM 1046497,,76.0,M,Resident received his 2nd vaccination 7 days earlier than the recommended 28 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/22/2021,4.0,PUB,,,,,,['Inappropriate schedule of product administration'],2,MODERNA,IM 1046499,GA,68.0,F,"pain, warmness, swelling, itching, redness at injection site and below site, bad headache, bad muscle aches and joint pain, mild fever, mild nausea, mild fatigue. The headache and muscle aches were the worst of all the symptoms. Symptoms lasted for 36 hours and then stopped. The swelling on arm lasted 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PVT,"Lovastatin 20 mg daily, Centrum multivitamins daily, vitamin D2 50,000 units once a week.",none,high cholesterol,I had a similar reaction to the newest shingles vaccine.,none known,"['Arthralgia', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Myalgia', 'Nausea', 'Peripheral swelling', 'Pyrexia']",2,MODERNA, 1046500,FL,70.0,F,2 days after started developing hives by the 3rd day all upper body was covered and upper lip was swollen - - that day I took a flight and went directly to emergency room - was given a shot of methy/PredniSolone sodium and a prescription for tablets - 2 a day for 5 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/07/2021,02/07/2021,0.0,UNK,"Amlodipine Besylate 5mg, Atorvastatin 20mg, Hydrochlorothiazide 12.5, Vitamin C, AZO Cranberry, Vitamin D",None,high blood pressure,,Demrol,"['Blood test', 'Lip swelling', 'Urticaria']",UNK,PFIZER\BIONTECH, 1046501,MI,73.0,F,"Pfizer-BioNTech COVID 19Vaccine EUA Fever of 99 degrees, slept for 32+ hours followed by aches for 12 hours. General malaise,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,PHM,"rovastatin, propafenone, xarelto, januvia, levothyroxin, metoprolol, memetasone furoate, omeprazole, benefiber, aspirin, cetirizine hydrochloride, cranberry extract, magnesium oxide, systaine eye drops, vitamin B complex, Vitamin D",none,"diabetes, afib,",,"sulfa, vicodin, dilaudid, leviquin, cipro","['Hypersomnia', 'Malaise', 'Pain']",2,PFIZER\BIONTECH,SYR 1046502,CA,67.0,F,"dizziness. Patient felt normal after drinking water. Sx resilved monitored for about 15-20 minutes after symptoms resolved. PSOB, palpitations, chills, ED Precautions discuseed. BP 160/90 Hx High Blood Pressure T98.0 New BP 151/81 HR 78 #21 allowed to go home advised to contact pcp if symptoms recur or",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,,,,,,"['Chills', 'Dizziness', 'Dyspnoea', 'Palpitations']",2,PFIZER\BIONTECH,IM 1046503,FL,70.0,F,"1 week after 1st vaccine, a large red itchy rash appeared on right arm at site of shot. I applied Extra Strength Benadryl itch stopping cream twice/three times a day. It last one week.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/14/2021,8.0,OTH,Famotidine 20 mg one tablet twice a day Sucralfate 1 GM at bedtime,None,None,,Sulfur,"['Injection site rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,SYR 1046504,NY,35.0,F,"Chills, muscle aches, chest tightness, headache, diarrhea, enlarged lymph node on my left side right under clavicle. Chills, muscle aches, headache and fatigue began about 14 hrs after injection and continued for about 24 hrs. Headache and fatigue continued on for 48hrs. Diarrhea probably started about 18 hrs after injection and was very mild throughout the next day. Enlarged lymph node didn't start until around 38 hrs later and although it has reduced significantly it is still a bit enlarged.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,PVT,,,GERD,,"Pinneapple, Penicillin","['Chest discomfort', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Lymphadenopathy', 'Myalgia']",2,MODERNA,SYR 1046505,AZ,32.0,F,"Low Grade Fever, Muscle Aches, and Join Paint from 2/10/2021 in the afternoon to 2/11/2021 in the morning. Fatigue that lasted until 2/11/2021 in the afternoon.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/10/2021,1.0,PUB,,,,,,"['Arthralgia', 'Fatigue', 'Myalgia', 'Pyrexia']",2,MODERNA,SYR 1046506,IL,74.0,F,"Sudden itch near site started 2/21; rash visible near site, continues today. Glands also swollen in previous three days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PHM,escitalopram 5mg; lisinopril 40 mg; rosuvastatin 5mg; ezetimibe 10 mg; aspirin 81 mg; valacyclovir 500 mg; chlorthalidone 12.5 mg; Vitamin D3; multi vitamin; Flonaise,none,hear attack 5/11/2018,,none,"['Injection site pruritus', 'Injection site rash', 'Lymphadenopathy']",1,MODERNA,IM 1046507,MI,32.0,F,"1st Night/2nd Day: extreme pain in arm, could not raise it, redness, extreme swelling 3rd Day: swelling, reduction in pain, reduction in redness 4 Day: Swelling, no pain, redness is a extremely light pink 5th Day/6th day: all symptoms gone 6th night/7th Day: swelling and redness returned, itchiness began 8th day: reduce in swelling, redness becoming larger, itchiness reduced 9th Day: redness becoming larger, swelling and itchiness gone 10th Day: Redness still becoming larger 11th Day: Redness is largest since shot, warm to the touch",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/18/2021,7.0,OTH,Sertraline 25 MG Norlyda .35mg paraguard Centrum multivitamin Cranberry 500mg,,VSD,,Penicillin Coconut,"['Erythema', 'Mobility decreased', 'Pain in extremity', 'Pruritus', 'Swelling']",1,MODERNA,IM 1046508,,79.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Extra dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046509,AZ,52.0,F,"One week prior to my second shot, I was diagnosed with an UTI. Since my last was 2008 and nothing had changed except the first Covid shot, I thought it was note worthy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/25/2021,17.0,PVT,Phentermine,None,None,,"Soy, erythromycin","['Condition aggravated', 'Urinary tract infection']",UNK,MODERNA,SYR 1046510,PA,25.0,F,Irregular menses/amenorrhea - Expected period was to begin on 01/25/2021 (after 1st vaccine dose). I never had any menstrual bleeding in the days to follow. My period has always been regular. Expected period was to begin on 02/22/2021 (after 2nd vaccine dose) and bleeding did not occur.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/25/2021,10.0,PUB,Wymzya Fe (oral birth control),None,None,,"Sulfa, PCN","['Menstruation irregular', 'Pregnancy test negative']",2,MODERNA,SYR 1046511,CO,73.0,F,"Type IV, delayed type hypersensitivity reaction",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/14/2021,8.0,PVT,,,"osteoporosis, osteoarthritis, h/o bowel obstructions",,,['Hypersensitivity'],1,MODERNA,IM 1046512,GA,86.0,F,"Fever, Stroke like symptoms, Sent to hospital for evaluation, admitted. (In house hospice)",Not Reported,,Yes,Yes,,Not Reported,N,02/12/2021,02/13/2021,1.0,SEN,"Tylenol, Ativan, Bisacodyl, Colace, Levothroxine, Metoprolol, Multivitamins, Remeron, Torsemide, Vitamin B12, VItamin, c, Vitamin d, Zinc, Zofran,",,"Alzheimers, Dementia, Atrial fibrillation, Anxiety, Hypertension, Lymphedema, Hypothyroidism, Scoliosis, Gerd, Thrombocytopenia, Endocarditis, PE, CHF",,Aspirin Penicillin,"['Neurological symptom', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1046513,MO,34.0,F,Dime size knot to L arm at site of infection. Grew to approx. 3 inches diameter following date.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/20/2021,2.0,OTH,none,none,Hidrarnitis Suppratika,Influenza vaccine,"Tramadol, Pine trees, bees stings",['Nodule'],2,PFIZER\BIONTECH,IM 1046514,SC,73.0,F,Admitted withy syncope and began to have pancytopenia,Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/03/2021,02/08/2021,5.0,PHM,"atorvastatin 10 mg QD, hydrochlorothiazide 12.5 mg QD, novolog sliding scale BID, losartan 25 mg QD mycophenolate mofetil 1000 mg BID, metformin 500 mg QD",,"diabetes, hypertension, asthma, degenerative arthritis, recurrent UTIs, dermatomyositis",,"latex, methotrexate, prednisone, nsaids, penicillin","['Haemoglobin decreased', 'Pancytopenia', 'Platelet count decreased', 'Syncope', 'White blood cell count decreased']",UNK,MODERNA, 1046515,FL,70.0,F,Vomiting 4-5 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,UNK,Zocor 20 mg Lisinopril 5 mg Nexium 20 mg,Sinus headaches Spring allergies,None,,None known,['Vomiting'],2,PFIZER\BIONTECH,IM 1046516,,78.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,SYR 1046517,UT,29.0,F,"Swelling, redness, pain and warmth at the injection site. Patient also reports hives on her chest and legs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,WRK,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Urticaria']",2,MODERNA,IM 1046518,TX,43.0,F,"Day 1: Sore injection site. Headache Day 2: headache, chills, night sweats, muscle aches, sore arm, extreme fatigue-could not function. Couldn?t focus on anything, had lay down and keep eyes closed, slept most of day and all night. Occasionally wake up with night sweats every few hours. Day 3: some tiredness and slight headache , sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,PUB,None. Took aleve around 2pm day of.,None,Asthma,,None,"['Chills', 'Disturbance in attention', 'Fatigue', 'Headache', 'Hypersomnia', 'Injection site pain', 'Myalgia', 'Night sweats', 'Pain in extremity']",2,MODERNA,SYR 1046519,WA,69.0,F,"At injection site: intense itch, red (2? x 3?), firm, hot skin, puffy; mild pain. (Covid Arm) Used OTC Cordison-10 for itch; 2 Tylenol extended tablet for pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/19/2021,8.0,PVT,Pepcid 20mg,None,GERD,Latex syringe reaction,"Latex, gold, base metals Lactose intolerance","['Injection site erythema', 'Injection site nodule', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 1046520,MT,35.0,F,Body aches & Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PVT,,,,,,"['Pain', 'Pyrexia']",2,MODERNA,IM 1046521,AK,17.0,U,given at less than the approved age,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/15/2021,02/15/2021,0.0,PVT,,,,,,['Product administered to patient of inappropriate age'],1,MODERNA,IM 1046522,,50.0,F,"Lightheadedness, throat itchiness/thickness,",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/16/2021,02/16/2021,0.0,UNK,,,,,,"['Dizziness', 'Throat irritation']",2,MODERNA,IM 1046523,OH,84.0,F,"Pt stated that the evening of getting 2nd dose of Covid vaccine she began to have ""charlie horses"" and stated she had involuntary shaking in her legs. Pt then stated she had a severe HA. Some body aches, upset stomach. Day after episode was ""doing much better"" and symptoms had resolved except for some mild fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,PUB,,,,,,"['Abdominal discomfort', 'Dyskinesia', 'Fatigue', 'Headache', 'Muscle spasms', 'Pain']",2,MODERNA,IM 1046524,,81.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Product preparation issue'],2,PFIZER\BIONTECH,IM 1046525,MI,45.0,F,Patient experienced dizziness and giddiness . Onsite EMS was called vitals BP 137/91 98% O2 room air HR 78 Patient refused evaluation/care released against medcial advice.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,PUB,,,,,,"['Blood pressure increased', 'Dizziness']",1,MODERNA,IM 1046526,LA,58.0,F,"1. and 2. Diarrhea and constipation - days 3-8 post vaccination. Vaccination on 2/12/2021 and diarrhea and constipation began 2/15/2021 and lasted until 2/21/2021 3. A lump where I received the vaccination from 2/12/2021 until 2/20/2021 4. Warmth around the injection site (4 cm in diameter) from 2/12/2021 until 2/20/2021 5. Extreme muscle spasms as a side effect of my vaccination 2/12/2021. They came on Monday 2/15/2021) but subsided Tuesday. Pain came back Wednesday and then Thursday I had to go home early and take 4 hours sick time. I then took 4 hours sick time on Friday in order to see the Nurse Practitioner. NP diagnosed as muscle spasms and prescribed Tizanidine 3 x day. I took two doses of Tizanidine (4mgs) on 2/19/2021 4pm and midnight and one dose 2/20/21 and muscle spasms are now resolved. The pain on Monday was on left and right flank (lumbar) but migrated to thoracic level by afternoon. On Tuesday it was not there. On Wednesday it was on left and right flank all day. On Thursday it was worse. The pain was an 8 on a scale of 0-10 with 10 being equivalent to labor pain. (Natural labor x 2, each 8 hours in 1994 and 2000). The pain 2/19/2021 was so severe that I left work in order to go home and made an appt with the medical provider for the next day. I saw the NP on Friday 2/19/2021 at 10.30am. Pain was worse when seated. Pain was extremely bad when driving. Pain lessened if I could press the area with my hand. Possible confounder is that I pushed a boat with arms outstretched on a trailer over uneven ground with my spouse on 2/13/2021 about 3 feet to its resting place. However, I was on the boat in particularly frigid weather outdoors for two hours prior to pushing the boat to its resting place.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/15/2021,3.0,WRK,1 baby aspirin / day,None,None,,None,"['Constipation', 'Diarrhoea', 'Flank pain', 'Injection site warmth', 'Muscle spasms', 'Urine analysis']",1,MODERNA,IM 1046527,,74.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Incorrect dose administered'],2,PFIZER\BIONTECH,IM 1046528,AL,77.0,F,"On Wednesday afternoon she had a fever of 103, was very fatigued. Got up in the middle of the night and had dry heaves, went back to bed and was okay. Her arm got really red, hot and blisters all over it like a sunburn. It is down to about the size of a half dollar today. The blisters burst and have made places, is still warm and sore and looks like it is drying up. Did look like a severe sunburn. She ran a little fever until Thursday night 2/18/21. The arm is still sore to touch today, 2/22/21. She took some Tylenol the night her fever was 103, then it went to 101. The fatigue is diminishing, she has slept a lot, but wonders if her arm is ever going to be right.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/16/2021,1.0,PUB,"Labetalol, Hydrochlorothiazide, Levothyroxine, Singular, Losartan, Requip, Gabapentin, Ambien, Prednisone, Aldactone, vitamin D, Plavix, Arthrotec. Allegra, Biotin, aspirin 81 mg, Tumeric, iron, Biotine mouthwash, B12, Refresh eye drops, c",None.,"High blood pressure, sleep apnea, incontinence, restless leg syndrome, thyroid condition, borderline diabetes, asthma, rheumatoid arthritis, temporal arteritis, anemia.",,None.,"['Blister', 'Erythema', 'Fatigue', 'Hyperaesthesia', 'Pyrexia', 'Retching']",2,MODERNA,IM 1046529,WA,59.0,F,"Itching on both elbows (outside) and discolored area near/above itching area on right elbow. On day 9, discoloration and itch at/around injection site. Itching alleviated with hydrocortisone cream 1% topically applied.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/14/2021,3.0,MIL,"Lisinopril 10 mg, Magnesium Glycinate, Iron, Vitamin C, Collagen, B Complex, essential oil blend: Frankincense Carterii, Black Pepper, Turmeric, Copaiba, Ginger, Oregano",None,"high blood pressure, back pain, muscle spasm/tightness, arthritis",,Kiwi,"['Injection site discolouration', 'Injection site pruritus', 'Pruritus', 'Skin discolouration']",1,MODERNA,IM 1046530,PA,85.0,F,"Called physician one week later and was diagnosed with ""COVID arm"" delayed hypersensitivity reaction. It was red/swollen, itchy. Physician advised her to receive 2nd dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,,,OTH,,,,,,"['Erythema', 'Peripheral swelling', 'Pruritus']",1,PFIZER\BIONTECH,IM 1046531,CA,33.0,F,"Patient became dizzy with palpitations. Developed flushing, sweating and shaky, take to Emergency room where a patient developed minimal residual erythema",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,None listed,none,none,,No known allergies,"['Dizziness', 'Erythema', 'Flushing', 'Hyperhidrosis', 'Palpitations', 'Tremor']",1,PFIZER\BIONTECH,IM 1046532,CA,42.0,F,hx of hives already which worsened responded to antihistamines-Which resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,PVT,Herbal remedies,NOne.,None,,None,['Urticaria'],2,PFIZER\BIONTECH,SYR 1046533,NJ,42.0,M,"Day 1-headache-no treatment Day 2-fever, headache, nausea, body aches, chills-no treatment Day 7-rash, left arm, topical ointment on continued through today Day 7-carbonated drinks taste flat continued through today",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/19/2021,6.0,PVT,Prilosec,,"Acid reflux, ibs",,,"['Headache', 'Nausea', 'Pain', 'Pyrexia', 'Rash', 'Taste disorder']",2,PFIZER\BIONTECH,IM 1046534,,77.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Product preparation issue'],2,PFIZER\BIONTECH,IM 1046535,WA,49.0,M,"Fatigue, nausea, slight fever, body aches. Lasted about 12 hours. Symptoms started almost exactly 24 hours after 2nd dose. Woke up the next morning feeling fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/12/2021,1.0,PVT,"Oxybutinin, multi-vitamin, vit B12.",None,None,,None,"['Fatigue', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1046537,NV,54.0,F,"One week after the vaccination, my left arm began to itch, and it was swollen, red, and hot to the touch. This lasted about five days before the inflammation and swelling went away. I also experienced a little bit of sort of light- headedness or sort of feeling just a little like my balance was off. As of today, Feb. 22, my arm is much better, but I am still a little bit light-headed. I have Rosacea, and that has also flared up horribly, and my face is a little bit red and inflamed",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,OTH,,,,,,"['Dizziness', 'Erythema', 'Inflammation', 'Peripheral swelling', 'Pruritus', 'Rosacea', 'Skin warm']",1,MODERNA,SYR 1046539,AK,17.0,F,dose given at less than the approved age,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/15/2021,02/15/2021,0.0,PVT,,,,,,['Product administered to patient of inappropriate age'],1,MODERNA,IM 1046540,,77.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Extra dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046541,IL,73.0,F,"A red area on arm, beginning on Feb. 21, slightly swollen, warm to touch, itching, about the size of a silver dollar. Symptoms are same today, Feb. 22, as yesterday.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PHM,"Metoprolol, 50 mg, 2X daily, turmeric",None,Prediabetic,,"Codeine possibly, outdoor mold, house mites","['Erythema', 'Peripheral swelling', 'Pruritus', 'Skin warm']",UNK,MODERNA,IM 1046542,,82.0,M,patient passed away with in 60 days of receiving a COVID vaccine,Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,,01/02/2021,02/15/2021,44.0,SEN,,,,,,['Death'],1,MODERNA, 1046543,IA,43.0,F,swelling of the lips and forearms on 2/22/2021 (6 days after vaccination),Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,PVT,"cyanocobalamin, diphenhydramine, doxylamine succinate, fluoxetine, topical ketoconazole shampoo, estroven+energy max strength, montelukast, emergen-c immune plus, multivitamin, tetrahydrozoline topical eye drops, triamcinolone topical, biot","hypothyroidism, HTN, Obesity with history of bariatric surgery, depression and anxiety, dyshidrotic eczema, seborrheic dermatitis of scalp,","hypothyroidism, HTN, Obesity with history of bariatric surgery, depression and anxiety",,sulfa antibiotics (hives),"['Lip swelling', 'Peripheral swelling']",1,MODERNA,IM 1046544,CO,70.0,F,"First Moderna vaccine (lot number 029L20A, left arm ) on 1/30 with no immediate reaction other than a metallic taste in my mouth for 12-14 hrs. Second vaccination scheduled for 2/29. On, 2/6, 7 days after the vaccine, the arm that received the Covid became tender, red, hard, swelling, very warm to the touch, metallic taste again. The raised area was about 2"" in diameter.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/30/2021,02/06/2021,7.0,PVT,,,,,Sulfa (rash) Sulfadiazine (rash),"['Dysgeusia', 'Erythema', 'Induration', 'Peripheral swelling', 'Skin warm', 'Tenderness']",1,MODERNA,IM 1046546,TX,55.0,F,"Dizziness, momentary loss of vision, loss of moto-muscular control (as if on the verge of seizing), loud ringing in ears accompanied by a full-body numbness (kind of like when one?s leg fall asleep from positioning, then tingles sharply w/numbness while waking )",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/13/2021,1.0,PHM,"Synthroid 112 mcg, L-Citrulline 1500 mg, NAC (N-acetylcysteine), Vit D",None,None,Age 20? With yellow fever vaccine. High fever 24 hours.,"Levothyroxine, Vicodin","['Dizziness', 'Hypoaesthesia', 'Somnolence', 'Tinnitus', 'Visual impairment']",2,MODERNA,SYR 1046547,,79.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046548,CA,78.0,M,"pt states that he started getting chills, fever, fatigue and headache that lasted around 24 hours. Pt no longer has these symptoms and has not contacted his PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PVT,"Niaspan, Lipitor, Plavix, Flomax, Fish Oil, B12, Multivitamin",no,no,,no,"['Chills', 'Fatigue', 'Headache', 'Pyrexia']",2,MODERNA,IM 1046549,,24.0,F,"Nausea, vomiting, abdominal pain, red chest, facial swelling,",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/17/2021,0.0,UNK,,,,,,"['Abdominal pain', 'Erythema', 'Nausea', 'Swelling face', 'Vomiting']",2,MODERNA,IM 1046550,,70.0,F,No reactions until one week later which was a rash/redness/itching at injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/21/2021,8.0,OTH,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,SYR 1046552,OK,65.0,F,"headache, nausea, chills, body aches and temperature",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,UNK,"Spiro/hctz, metformin, seroquel, lisinopril, tizzanadine, vit d, magnesium, fish oil, aspirin 350",,,,morphine,"['Body temperature', 'Chills', 'Headache', 'Nausea', 'Pain']",UNK,MODERNA,IM 1046553,MT,50.0,F,"Headache, Chills, Body aches, Fatigue, Sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PVT,,,,,,"['Fatigue', 'Feeling cold', 'Headache', 'Pain', 'Pain in extremity']",2,MODERNA,IM 1046554,VA,45.0,F,"nausea, vomiting, fever, chills, sweats, body aches, headache, sore arm. I got my shot at 3:30pm and the symptoms started at 1am that night. 2 days later they have mostly subsided but I am still very tired and occasionally sweating.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/20/2021,1.0,OTH,"Generic zyrtec, Mirena IUD, multivitamin, probiotic supplement, fish oil, cranberry supplement",Yeast infection,"asthma, allergies, migraines",,0,"['Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'Vomiting']",2,MODERNA,SYR 1046555,MN,49.0,F,"Fever, headache, body aches, joint pain, nausea, swollen glands in the neck, extreme fatigue, weakness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/10/2021,1.0,WRK,Vitamin D,None,None,Similar reaction to the above. Age 48. Date was 1/12/21,None,"['Arthralgia', 'Asthenia', 'Fatigue', 'Headache', 'Lymphadenopathy', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,IM 1046556,ID,27.0,M,Patient presented to Urgent Care 3 days after his second dose of Pfizer COVID-19 vaccination.. He reported a 10 day issue of a left axilla mass (12 cm) with new onset of tenderness.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/19/2021,3.0,MIL,None,None,None,,NKA,"['Axillary mass', 'Full blood count normal', 'Tenderness', 'Ultrasound scan abnormal']",UNK,PFIZER\BIONTECH, 1046557,OR,57.0,F,"Severe dizziness (even with sitting and lifting head) associated with nausea, especially when I tried to move about and fetch supplies like water and ibuprofen, chills and shivers, trembly weakness, joint pain lasting 2days. Required ibuprofen every 4hours for 30hours and sporadically thereafter to manage symptoms. I was ready to call 911, but was able to reach friends as a safety check through the night and the next couple days. Very difficult to manage this living alone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PUB,"omeprazole, losartan","IBS, HTN",see above,,"fluconazole, erythromycin","['Arthralgia', 'Asthenia', 'Chills', 'Dizziness', 'Dizziness postural', 'Nausea', 'Tremor']",2,MODERNA,IM 1046558,MD,53.0,M,Patient was hospitalized with chest pain and elevated BP. Patient's blood pressure medication regimen was optimized and patient was discharged,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/25/2021,02/12/2021,18.0,PVT,"Amlodipine, benazepril, bupropion, diphenhydramine, ibuprofen, levothyroxine, lovastatin, omeprazole, pregabalin, zolpidem",,"Melanoma, hypertension, hyperlipidemia",,NKA,"['Blood pressure increased', 'Chest pain']",2,PFIZER\BIONTECH,IM 1046559,PA,65.0,F,"-large welt at injection site after 12 hours, lasted for 1 week - fever, chills and body aches after 24 hours., lasted for 24 hours. - Eyes irritated- feel like they are coated with something and skin around eyes is itchy, still going on.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/13/2021,0.0,UNK,celecoxib pantoprazole excedrine migraine,no,arthritis goiter acid reflux,,no,"['Chills', 'Eye irritation', 'Eye pruritus', 'Injection site swelling', 'Pain', 'Pyrexia']",1,MODERNA,SYR 1046560,WA,54.0,F,"Almost immediately got a very bad headache and nausea. About 30 minutes later I got foggy in the head. Within an hour, I felt exhausted. I went to sleep until about 7pm and when I woke up I felt really nauseous and still very tired. I had a little broth and went back to sleep. on 02/19/2021 at 1am I woke up feeling really hot and had horrible body aches. Even my joints hurt. I took my temperature and it was only 99.2 but my temperature usually runs 97.4 or 97.6. I woke up on 02/20/2021 and my left eye was crusted over just like the first vaccine. My body aches and nausea lasted until 02/20/2021. In the evening of 02/20/2021 I noticed about 10 little red bumps in various places on my body. (2 on left arm, one on back neck in hairline, two on upper back, one on chest, two on left leg, one on lower back and one on left buttock. Today is 02/22/2021 and I am still feeling fatigued. It's not as bad as it was over the weekend but I am still tired. My arm was much sorer with this injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,OTH,Welbutrin and multi vitamins,"none, just had a slight headache prior to getting vaccine",none,1998 and 1999 flu vaccine,"almost all pain meds, sensitive to several other medications and flu vaccine","['Arthralgia', 'Body temperature increased', 'Condition aggravated', 'Eyelid margin crusting', 'Fatigue', 'Feeling abnormal', 'Feeling hot', 'Headache', 'Immediate post-injection reaction', 'Nausea', 'Pain', 'Pain in extremity', 'Rash', 'Rash erythematous']",UNK,PFIZER\BIONTECH,IM 1046561,PA,65.0,M,Patient received his first Covid-19 vaccine here in this office on 2/10/2021. The following day he developed redness itching swelling of his left upper arm. Patient seen in the office on 2/17/21 and area is still present. This does appear to be a local allergic reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/11/2021,1.0,PVT,"ASA, Atenolol, Ezetimibe, Glimepiride, Janumet, Jardiance, Losartan, Omeprazole, Rosuvastatin",No,"Type IIDM, HTN, GERD, Hyperlipidemia",,"Lipitor, Lisinopril, Robitussin, Vytorin","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Local reaction']",1,MODERNA,IM 1046562,FL,70.0,F,"Became extremely hot & went to check thermostat in house. Suddenly had no feeling in legs, i.e., felt like legs did not exist. Could not hold myself up. Fell down and landed on right side hip & knee. After a minute or two, could get up on my own and feeling returned to legs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/16/2021,1.0,PUB,"Glucosamine Chondriton, Multi Vitamin, Cod Liver Oil, Vitamin D3, B12, Calcium, Ashwagandha, Lutein, Guggul. Triphala, Shatavari",None,None,,None,"['Fall', 'Feeling hot', 'Sensory disturbance']",UNK,MODERNA,SYR 1046563,PA,60.0,M,"After he exercises ever since he received the vaccine, he has been getting exercise induced urticaria that lasts for 1-2 hours and is moderately pruritic. He said he feels as red as a lobster for an hour or two before it goes away.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/17/2021,8.0,OTH,,,,,,"['Erythema', 'Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,IM 1046564,KS,77.0,F,"I had Covid on 25 Nov. 2020. I had extreme fatigue, shortness of breath, aching, headaches and abdominal pain. I have IBS which flared up during this time. It took me December and January to finally get over the fatigue part. When I received my vaccination on Feb. 12, 2021 (Moderna) by that evening I began to run a temp. of 102-103. I had chills, headache, abdominal pain (worse than in Nov.), fatigue, some dizziness, and short of breath. I felt like I had Covid all over again! I was down for 5 days. On Sunday afternoon, Feb 14 I went to the Clinic to see the doctor on call. I was told they could not test me since I had Covid November 25 and it hadn't been 90 days and I would still have the antibodies.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,WRK,"Atenolol, Larsartin, Amlodopine, simvastatin, Gabapentin,",none,"IBS, Chronic low back pain after 2 surgeries",,"Sulfa, erthromycin","['Abdominal pain', 'Body temperature increased', 'Chills', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Headache']",1,MODERNA, 1046565,,78.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation error', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046566,MT,59.0,M,DIzziness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PVT,,,,,,['Dizziness'],2,MODERNA,IM 1046567,IL,65.0,M,"48 hrs of headache, fatigue, chills local induration & tenderness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,Vit D 3000 iu QD multivitamin QD Calcium,none,none,,NKA,"['Chills', 'Fatigue', 'Headache', 'Induration', 'Tenderness']",1,MODERNA,IM 1046568,NY,69.0,F,"extreme muscle soreness, tired- couldn't get out of bed. muscle ache throughout the body, head ache, nausea, still not feeling well",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/20/2021,0.0,SCH,"tylenol pm night time Nyquil,",,crones disease- mild,,"penicillin,","['Fatigue', 'Headache', 'Malaise', 'Mobility decreased', 'Myalgia', 'Nausea']",2,MODERNA,SYR 1046569,PA,39.0,F,"Received shot on 2/18, notice large raised, red, hot rash on 2/21 that had spread around large area of upper arm near injection site. Rash was sore closer to injection site. At the time of this report (2/22) rash still is still apparent.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/21/2021,3.0,PVT,Multivitamin - Womens One a Day Vitamin D - 2000 Probiotic Calcium,None,None,,Chlorahexidine - sensitivity Sulfa allergy,"['Rash erythematous', 'Rash papular', 'Skin warm']",2,MODERNA,IM 1046570,IL,42.0,F,"Slight itching of site over the entire week following injection, but nothing bothersome. As of Friday evening, Feb. 19, it became sore again. By morning on Saturday, Feb. 20, there was a pink blotch on the skin above/around the injection site, and there was a noticeably hard lump under the skin. The site was also very feverish. (I did not have a fever, just the upper arm was quite warm.) This all lasted until midday Sunday, Feb. 21. By bedtime, it felt better. Monday there was still a pink spot on the arm, but the hardness & fever were gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/19/2021,7.0,OTH,"Vitamin E, Vitamin C, Magnesium, Turmeric, Cinnamon, Coconut Oil",None.,None.,,Sensitivity to Prednisone.,"['Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Pyrexia', 'Rash macular']",1,MODERNA,SYR 1046571,AZ,67.0,F,"Redness, itching around injection site. Delayed symptoms with onset at approximately 9 -10 days after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/20/2021,11.0,OTH,"Multivitamin, calcium, magnesium, omeprazole",UTI,"Diffuse large B cell lymphoma (in remission), GERD",,None,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 1046572,TN,49.0,F,"Swelling at injection site, target/circle type redness around injection site, itching at injection site, rash with itch on top of left shoulder",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/17/2021,7.0,MIL,Wellbutrin Vitamin C Vitamin D Zinc Singulair,No illness,"Chronic Kidney stone; last surgery for it was Dec 31, 2020 Asthma Migraines",,"Cipro (anaphylaxis) Some melons (watermelon, cantaloupe) - itchy tongue","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Rash']",1,MODERNA,SYR 1046573,AK,33.0,M,syncopal episode; reported having a syncopal episode previously following a blood draw,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,PVT,,,,,,['Syncope'],1,PFIZER\BIONTECH,IM 1046574,,76.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Product preparation issue'],2,PFIZER\BIONTECH,IM 1046575,CA,75.0,F,"flush in face, shakiness. facial redness noted. Pt has numerous allergic rxn hx: 5x worsening. sent to ED for evaluation and montioring. BP 141/76 HR 84 02 97",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,PVT,,,,,,"['Erythema', 'Flushing', 'Tremor']",2,PFIZER\BIONTECH,IM 1046576,OR,45.0,F,She developed pericarditis/myocarditis and was diagnosed 4 days after receiving second dose of Covid19 Moderna vaccine,Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/12/2021,02/16/2021,4.0,OTH,"ELURYNG, over the counter eye drops",,"Sjogren's Syndrome - mild, mostly with just dry eyes",1st dose Moderna Covid 19 - sore arm and rash,No,"['Blood creatine phosphokinase increased', 'Catheterisation cardiac normal', 'Echocardiogram normal', 'Electrocardiogram ST segment elevation', 'Electrocardiogram abnormal', 'Myocarditis', 'Pericarditis', 'Red blood cell sedimentation rate increased', 'Troponin increased']",UNK,MODERNA,IM 1046577,OR,64.0,F,hoarse voise s/p 2nd vaccine 20 mins after vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,albuterol,unknown,unknown,,"steroids', foods, fragrances",['Dysphonia'],2,PFIZER\BIONTECH,IM 1046578,WI,76.0,M,"Pt received first dose of Pfizer COVID-19 at Vaccine Clinic 2/3/2021. Patient had previously tested positive for COVID at a community testing center on 10/2/2020, but is outside of the 90 day window where retesting is not recommendation. Pt began having headache and dizziness 2/21/2021, BP checked at home and was very elevated. Presented to ED and was diagnosed with hypertensive urgency, then admitted. Pt tested for COVID via PCR, positive.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/03/2021,02/21/2021,18.0,PVT,"aspirin, atorvastatin, bupropion, docusate sodium, donepezil, lansoprazole, tamsulosin, venlafaxine",,"Vertigo, valvular disease, sprain of thoracic region, obesity, hx NSTEMI, lateral epicondylitis of left elbow, hyperlipidemia, hyperglycemia, HTN, heart murmur, GERD, OA, generalized anxiety disorder, fatty liver, depressive disorder, CAD, BPH, Aortic valve stenosis",,"Contrast, lisinopril","['Blood pressure increased', 'COVID-19', 'Dizziness', 'Headache', 'Hypertension', 'Hypertensive urgency', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1046579,NY,58.0,F,"burning, tingling, pain started in upper extremities during the daytime ! started about 9 days after second dose of Moderna Vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/06/2021,10.0,OTH,"Magnesium, Metformin, Hydrochlorothiazide, Avapro, Estrogen, Zinc, Green Tea Extract with EGCG + Vitamin C pill form, Synthroid, Zenwise Digestive Enzymes and Prevagen",no illnesses,"HTN, Type II Diabetes well contolled,",,Sulfur drugs,"['Blood thyroid stimulating hormone normal', 'Burning sensation', 'Pain in extremity', 'Paraesthesia']",2,MODERNA,IM 1046580,NC,65.0,F,"After 2 days of getting vaccine, on Feb 22, my arm had a huge rash and was very tender where my shoulder was sore. I took a picture. I didnt notice any redness prior to this but wasn't looking for it. Do you know when it will go away. It is larger than when a baseball hits you in an arm and the same amount of tenderness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/22/2021,2.0,PVT,"Vit D 3 25 mcg, B12 2000mcg, B complex with C , Ropinirole 3 mg, Atorvastin 20 mg",none,none,,sulfu - mild rash reaction,"['Arthralgia', 'Rash', 'Tenderness']",2,MODERNA,IM 1046581,MI,30.0,M,Patient experienced general malaise unknown cause. Onsite EMS was called vitals BP 146/70 100% O2 room air HR 91 Patient refused evaluation/care released against medcial advice.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/08/2021,0.0,PUB,,,,,,['Malaise'],1,MODERNA,IM 1046582,CA,55.0,F,"Patient started feeling dizzy, hot, and vision became blurry while monitoring post vaccine. Patient was provided with water, and laid down. Symptoms resolved within 10 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,UNK,,,,,,"['Dizziness', 'Feeling hot', 'Vision blurred']",2,MODERNA,IM 1046583,,75.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046584,OH,42.0,F,Symptoms began 10 minutes after vaccine administration as tingling in the tongue and progressed to swelling of the toungue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,WRK,Daily multivitamin,None,None,,Shellfish,"['Paraesthesia oral', 'Swollen tongue']",1,MODERNA,IM 1046585,NY,65.0,F,"?Moderna COVID?19 Vaccine EUA? About a week after my first dose (only immediate side effect, about 12 hours after shot, was stiff left arm/shoulder for about 3 days), I had the WORST genital herpes attack that I've had in literally 40 years, with extremely swollen labia, excessively ""weeping"" sores, intense itching and pain. The shot was the only variable in my routine health and healthcare to which I can attribute this; the herpes attack finally began to heal, but then repeated itself, not as bad as the first one. During this time I have been taking Valcyclovir and Acyclovir cream, prescribed by OB/GYN. A few days into the initial herpes attack, my hands and face swelled and broke out in a case of (probably) dermatitis (which I've had once or twice in the last 2 years), covering my arms, legs, hands, somewhat belly and back, with itchy hives which are still healing. Was prescribed by dermatologist Hydroxyzine HCL 10 MG 3x/day + Triamcinolone Acetonide lotion USP 0.025% topical ointment, which are helping to relieve itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/05/2021,7.0,PUB,"insulin: Levemir, Fiasp Synthroid",none,"Type 1 diabetes (late onset); Hashimoto disease; have had Herpes Simplex 2 for 45 years, mostly inactive",,allergic to sulfa drugs,"['Condition aggravated', 'Dermatitis', 'Dermatologic examination', 'Genital herpes', 'Genital lesion', 'Genital pain', 'Gynaecological examination', 'Herpes simplex', 'Injection site reaction', 'Labia enlarged', 'Musculoskeletal stiffness', 'Peripheral swelling', 'Pruritus', 'Pruritus genital', 'Swelling face', 'Urticaria']",1,MODERNA,IM 1046586,IA,71.0,M,"Aprox 24 hrs after vaccine I had extreme pain in my left upper jaw tooth rear tooth, I mean extreme like the tooth was dying , then headachy on the left side of my head, and then extreme tiredness! The tooth pain has reduced to a mild pain but still hard to eat, the extreme tiredness has lessened a little buy today the 21st it is still there!",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,PHM,"Pradaxa, Sotolol, Amilodepine, Vit D3, Zinc, Fish Oil, Gemfibrozil, Red Yeast Rice, Curcumin",,"Potential for A fib, high chorlesterol,",,"Pseudfederin, Statins","['Fatigue', 'Feeding disorder', 'Headache', 'Pain in jaw', 'Toothache']",1,PFIZER\BIONTECH,IM 1046587,CA,45.0,F,"PATIENT CALLED PHARMACY ON 02/22/21 STATING SHE RECEIVED SECOND DOSE OF MODERNA VACCINE ON 02/18/2021 AND HAD TYPICAL SYMPTOMS OF CHILLS, HEADACHE, AND FEELING TIRED DAY OF VACCINE. HOWEVER, ON 02/20/21 SHE NOTICED A RASH ON DIFFERENT PARTS OF HER BODY ALONG WITH HIVES.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/20/2021,2.0,PHM,SYNTHROID PROZAC ZYRTEC VITAMIN D,NONE,FIBROMYALGIA HASHIMOTOS,,NONE,"['Chills', 'Dermatitis acneiform', 'Fatigue', 'Headache', 'Urticaria']",UNK,MODERNA,IM 1046588,OH,71.0,F,Presented to ER with subsequent admission two days after receiving second dose of COVID 19 vaccine with Lactic Acidosis/Sepsis. She was hospitalized for 4 days,Not Reported,,Not Reported,Yes,4.0,Not Reported,U,02/07/2021,02/09/2021,2.0,PVT,,,,,,"['Lactic acidosis', 'Sepsis']",2,PFIZER\BIONTECH,IM 1046589,CO,62.0,F,Three inch Red warm circle over injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/22/2021,9.0,WRK,Statins,None,Celiac,,"Pen vk Dilaudid, Morphine (All opioids)","['Injection site erythema', 'Injection site warmth']",UNK,MODERNA, 1046590,,75.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation error', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046591,MA,31.0,F,"At 24 hrs, warm, red, itchy spot appeared on arm. Disappeared into a bruise at 1 week post injection. Reappeared at the same size as a red, warm, itchy spot on arm with a hard bump on the middle.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/14/2021,2.0,PUB,"Metformin, birth control, Multivitamin, vitamin e, vitamin c",None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 1046592,,94.0,F,"Per patient's daughter, the patient told her that she ""passed out"" while she was on the toilet the day following vaccination. States she felt weak. Per daughter the patient is doing fine now.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PUB,,,,,,"['Asthenia', 'Loss of consciousness']",2,MODERNA,IM 1046593,MI,81.0,F,"Macular papillary rash on thighs, buttocks, and trunk. She took a dose of benadryl, and I advised she take Claritin and zyrtec.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/06/2021,02/08/2021,2.0,SCH,custor 10 mg daily baby aspirin 81 mg daily,No,hyperlipidemia interminent AFIB perfovascular disease thyroid nodule,,None,"['Monocyte count increased', 'Neutrophil count increased', 'Rash', 'Rash maculo-papular', 'White blood cell count increased']",1,MODERNA,SYR 1046594,AR,37.0,M,"Other than brusing and a sore muscle, on 01/05/2021 at 3AM, I noticed my stomach felt bloated after drinking soda. It got worse through out the day. At 5:30PM, I took medicine for gas. By 6:30PM, the pain was worse so I went to UC and after a check up, I was sent to the ED for a CT scan and they found an inflamed appendix. I had surgery to have it removed. After surgery, I developed asthmatic pneumonia which led to a 7 day hospitalization.",Not Reported,,Not Reported,Yes,7.0,Not Reported,Y,01/02/2021,01/05/2021,3.0,SEN,No,I have asthma that has been under control for the past 20 years.,No,,No,"['Abdominal distension', 'Appendicectomy', 'Appendicitis', 'Asthma', 'Computerised tomogram abdomen abnormal', 'Contusion', 'Myalgia', 'Pneumonia']",1,MODERNA, 1046596,,91.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation error', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046597,OR,36.0,F,"muscle pain, fatigue, seizures",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,WRK,none,none,seizures,,amoxicillin,"['Condition aggravated', 'Fatigue', 'Myalgia', 'Seizure']",2,MODERNA,IM 1046598,MA,29.0,F,"Nausea, fever, chills, aches and pains, fatigue, headache, neck ache, ear pain, swollen lymph nodes, sore arm. These symptoms lasted about 2 days total.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,OTH,,,Asthma,,,"['Ear pain', 'Fatigue', 'Feeling cold', 'Headache', 'Lymphadenopathy', 'Nausea', 'Neck pain', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1046599,MA,90.0,F,Patient received the first dose of Moderna COVID vaccine on 1/11/2021. It was documented in her immunization record. She was admitted to a nursing facility on 1/13/2021 for short term rehab. Her vaccination records were sent with her when she was admitted to the nursing facility. She then received a dose of the Pfizer COVID vaccine on 1/28/2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/28/2021,17.0,PVT,? Oxycodone HCl 5 MG Tablet Take 1 tab (5mg) every morning and 1/2 tab (2.5mg) every night. Isolated MOTs. 42 Tablet 0 ? DULoxetine HCl 20 MG Capsule Delayed Release Sprinkle Take 40 mg by mouth one time a day 60 Capsule 1 ? Lidocaine,none,"HTN, HLD, PAD s/p x2 SFA stenting, COPD with 2L home 02, CAD, constipation, hypothyroidism, mild cognitive impairment",,none,['Interchange of vaccine products'],1,PFIZER\BIONTECH,IM 1046600,MD,90.0,F,"Patient was admitted and treated for severe PE and DVT, as well as hypoxia and paroxysmal SVT. Pt was discharged to inpatient rehab when stable",Not Reported,,Not Reported,Yes,10.0,Not Reported,U,02/09/2021,02/12/2021,3.0,PVT,"Amlodipine-benazepril, celecoxib, furosemide, levothyroxine, metoprolol succinate, tramadol, trazodone",,"Arthritis, hypertension",,NKA,"['Deep vein thrombosis', 'Hypoxia', 'Pulmonary embolism', 'Supraventricular tachycardia']",1,PFIZER\BIONTECH,IM 1046601,MT,37.0,F,Rash & Hot and cold flashes,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/17/2021,1.0,PVT,,,,,,"['Feeling cold', 'Hot flush', 'Rash']",2,MODERNA,IM 1046602,FL,59.0,F,A large red area on my arm. Sore in general and to touch. Just started today - one week and two days after the shot was given.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/22/2021,10.0,PHM,"Levothyroxine, Vitamin D, Potassium-magnesium, Glucosamine, Omega 3 fish oil, Collagen-C, Calcium, Zinc, Multi-Vitamin,Zicam",none,none,,none,"['Erythema', 'Pain', 'Tenderness']",1,MODERNA,SYR 1046603,,75.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation error', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046604,CA,69.0,F,"sore arm, fatigue, rash,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/07/2021,2.0,UNK,"Synthroid, align probiotic, systane eye drops, zolpidem 5mg",,GI issues,,"ceclor, sulfa drugs","['Fatigue', 'Pain in extremity', 'Rash']",1,MODERNA,IM 1046606,IL,32.0,F,"itchy, round rash around injection site. firmness and mild tenderness noted at site as well",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/20/2021,8.0,PUB,"Requip, Gabapentin, Omeprazole, Zyrtec, Magnesium, Vitamin D3, and Mirena",,"Restless Leg Syndrome, GERD, seasonal allergies",,"Cipro, Bactrim, Phenergan","['Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site rash']",UNK,MODERNA,IM 1046607,,22.0,F,"Abdominal pain, pale, hypotensive, tachycardic. Received epi pen and transport to ER",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/20/2021,0.0,PVT,,,,,,"['Abdominal pain', 'Hypotension', 'Pallor', 'Tachycardia', 'Tryptase']",1,PFIZER\BIONTECH,IM 1046608,AZ,77.0,F,"fever: 102.8, chills, muscles aches, ""fuzzy"" head, took 2 advil, fever broke after few hours, aches remained for 42 hours, repeated advil twice during that time. much better now (vaccination was working)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PHM,"metropalol, atorvastatin, meloxicam, allegra, dulera, dymista, albutorol, singular,",none,"chronic sinusitis, IBS, hypertension, high cholesterol, pre-diabetic",,none known,"['Chills', 'Feeling abnormal', 'Myalgia', 'Pyrexia']",2,MODERNA,IM 1046610,CA,80.0,M,"Fever (up to 102 F); headache; mental confusion; lack of responsive speech or delay in responding to questions. Symptoms began around 11:30 a.m. on Feb. 21. Administered one Tylenol at 2:30 p.m. on Feb. 21. By 6 p.m. on Feb. 21, the fever and headache abated. But confusion and lack of speech continues to Feb. 22 (10:30 a.m.) as I prepare this report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,PVT,1) Levetiracetam; 2) Topiramate; 3) Eliquis; 4) Carbidopora/Levodopa; 5) Donepezil; 6)Tamsulosin; 7) Mirtazapine; 8) Vitamin D-3; 9) Vitamin B-12; 10) Adult Vitamin,None,Seizure disorder Parkinson's Disease Inguinal hernia,,None,"['Aphasia', 'Confusional state', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1046611,,78.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Extra dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046612,VA,71.0,F,hard lump under skin at injection site; very tender to touch; still sore at site after 7 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/15/2021,02/15/2021,0.0,PHM,,,,,,"['Injection site induration', 'Injection site pain']",UNK,MODERNA, 1046613,,70.0,F,patient passed away within 60 days of receiving a COVID vaccine,Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,,01/28/2021,02/22/2021,25.0,SEN,,,,,,['Death'],1,MODERNA, 1046614,,36.0,F,"Developed Covid-arm: raised, warm to the touch, red area at site of injection on the morning of 01/18/2021 . Later that evening broke out in hives from my hips to my ankles. Spoke with my allergist who said it was most likely an inflammatory response from the vaccine and to treat with Benadryl. Took Benadryl and hives were gone by the next morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/28/2021,9.0,PVT,"Synthroid, Spironolactone",asthma,asthma,,none,"['Inflammation', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Urticaria']",1,MODERNA,IM 1046615,ID,,F,"Client waved nurse over to observation area and stated, "" I feel a little strange"". I asked her to describe how she was feeling and she was thirsty and feeling a bit anxious. She stated she lived alone and her daughter was out of town. I asked her if I could take a few vitals. She agreed to having them taken behind the curtain area. VS: BP 134/72, P 66, R 16,Temp: 97.1. SPO2 99%Client stated that she normally has pretty low BP so this was elevated for her. I offered her a bottle of water and she accepted. We talked about her daughter and people we know in common. This helped calm her and her next vitals were 126/56, P 73, R 16 SPO2 98% . Client stated that she was feeling better. By 10:55 am she was moved back to group waiting area and waited a few more minutes. She did not accept the offer of a phone call for someone to come pick her up. Cleint stated that she felt like she could drive herself home as she did not live far away. Client last Vitals 10:57 am : BP 115/67 P; 67, R 14, SPO2 99%. Client walked out of facility at 11:01 am .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,WRK,,,,,None,"['Anxiety', 'Feeling abnormal', 'Thirst']",UNK,PFIZER\BIONTECH,IM 1046617,MI,71.0,F,COVID - arm (rash),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,02/05/2021,8.0,PUB,levothyroxin vitamin D multivitamin tab.,,HASHIMOTO,,amoxicillan,['Rash'],1,MODERNA,SYR 1046618,TX,87.0,F,"About 2 days after receiving the vaccine, she bitter taste in her mouth. She still has it as of today. It is kind of metallic taste. She also has blurry vision and swelling in her eyes. It felt like she had discomfort behind her eyes. It was causing difficultly reading. This lasted about 2 weeks. It is not as blurry but her vision is not what it is was prior to receiving the vaccine. She went to Eye Center, they told her they didn't know what it was from. They gave her some eye drops and gave her antibiotic/steroid cream. She has a follow up appointment 2/26/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/18/2021,2.0,PVT,"Flexeril 10 MG daily, Lexapro 10 MG twice a day, Aspirin 81 MG daily, Claritin 10 MG twice a day, Multi-vitamin gummy (2 gummies daily), Vitamin C gummy (2 gummies every day), Prilosec 40 MG daily",,"Allergies, back pain, previous back surgery, carpal tunnel syndrome, Osteoarthritis",,"Penicillin, Vinegar, Cheyanne pepper, Prednisone","['Dysgeusia', 'Eye swelling', 'Vision blurred']",1,PFIZER\BIONTECH,IM 1046619,,64.0,F,Medication leaked out injection site causing suboptimal dose. Dose was repeated later for a total of 3 injections,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/16/2021,01/16/2021,0.0,PVT,,,,,,"['Injection site extravasation', 'Product use issue']",1,PFIZER\BIONTECH,IM 1046620,AZ,55.0,F,"Big hive at shot site with 3 smaller hives in area. Area is very hot and extremely itchy. It's been this way since 2am on Friday 2/19/21. I take Benadryl at night and cortizone and ice on it during the day. As of Monday, 2/22/21 it is still the same.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,PVT,Lialda Progesterian Atervastatin Linsinapril tramadol Multi Vitamin D3 vitamin Magnesium Turmeric,"I had insert of hormone pellets 1 day prior to vaccination . 2 weeks prior to vaccination I had 2 steriods shots into L4-L5, and L5-S1",Bone degeneration w/ 2 pelvic fusions as SI Joint on left. Ulcerative Colitus,,Eggs Morphine Sulpha Erithermicyn,"['Injection site pruritus', 'Injection site urticaria', 'Injection site warmth']",2,MODERNA,SYR 1046621,,82.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046622,NJ,75.0,F,pt stated that she was very tired that day and next day. On 1/23/2021 pt stated she developed a enlarged lymph node under her left arm. Pts doctor sent her for mammo and sonogram test for the swollon lymph nodes. Pts doctor let her know that these symptoms were directly related to taking the Covid Vax. Pt states that the swelling is not completely gone but it is smaller and getting better.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,PVT,no,no,no,,"antibiotics, grass, dogs","['Fatigue', 'Lymphadenopathy', 'Mammogram normal', 'Ultrasound scan normal']",1,MODERNA,IM 1046623,NY,78.0,F,"Shortly after I received the vaccine, and stood up, I felt a bit light-headed so I continued to walk around the store for a few minutes. Later in the afternoon, my right arm where I had the vaccine was very painful, reducing the ability to raise my arm, which continued through the following day. On Day 3, it was still a bit sore, but improving. On Day 4, I was totally fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PHM,"Armour Thyroid 60 mg. , Norvasc 2.5mg, Crestor 5 mg, Bayer Aspirim 81 mg Magnesium 125 mg, Calcium 800 mg, , Vitamin D, 1000 mg Biotin 1,000 mg, Vitamin C 500 mg, Tumeric 500 mg",No,No,Similar pain and swelling upon getting first Shingles Vaccine.,Xidra and Zithromax,"['Dizziness', 'Injection site movement impairment', 'Injection site pain']",UNK,MODERNA, 1046624,MA,50.0,F,"dizziness, headache, ear pain, popping sensation ears, feeling hot and cold, chills, diaphoresis, night sweats, severe fatigue, sinus congestion, runny nose, post nasal drip, sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,OTH,"tenofovir 300mg by mouth daily Vitamin d 50,000IU 3x/ week Calcium 500mg 3x/ week",None,Hepatitis B carrier,Influenza vaccine egg allergy. Got arm redness after MMR and varicella vaccines.,Penicillin Benzoyl peroxide Apples Eggs,"['Chills', 'Dizziness', 'Ear discomfort', 'Ear pain', 'Fatigue', 'Feeling of body temperature change', 'Headache', 'Hyperhidrosis', 'Night sweats', 'Pain in extremity', 'Rhinorrhoea', 'Sinus congestion', 'Upper-airway cough syndrome']",2,PFIZER\BIONTECH,IM 1046625,AZ,48.0,F,"Friday injection site hurt almost immediately (first dose didn't feel anything until 6 hours after shot)... started to ice arm an hour after appointment and continued to ice throughout the day Friday. Saturday morning the injection side was significantly swollen (bump and felt like a knot) and continues to be swollen and ache as of Monday a.m. Have a red circular patch around injection site which also occurred after first shot and lasted 10 days. Saturday woke up with bad headache... took tylenol and slept.. headache gone by late afternoon. Sunday morning woke up covered in a rash that was from my neck to below my belly button on front side, entire back area (including neck) and both sides of torso. Took 2 doses of Benadryl on Sunday. Rash has faded (not as red) and took another dose of Benadryl Monday morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/21/2021,2.0,OTH,birth control pills,none,none,,none that aware of,"['Headache', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Rash']",2,PFIZER\BIONTECH,IM 1046627,CA,69.0,F,"Red, itchy spot at injection site appeared about 8 days after injection. No treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/20/2021,8.0,PUB,"Atorvastatin, daily multivitamin",None,Hyperlipidemia,,None known,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,SYR 1046628,CA,86.0,F,daughter stated patient was found on the floor at her facility and was transported to the hospital where she was diagnosed with a CVA. Unknown if this event was related to her COVID vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/13/2021,2.0,PVT,,,,,,['Cerebrovascular accident'],1,MODERNA,IM 1046630,,75.0,F,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,['Product preparation issue'],2,PFIZER\BIONTECH,IM 1046631,PA,42.0,F,"Moderna vaccine as given as indicated above but recorded in chart as Pfizer-BionTech COVID-19 vaccine, resulting in second dose being given as Pfizer-BionTech vaccine rather than Moderna",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,PVT,,NOne,Obstructive sleep Apnea Obesity Reflux esophagitis Vitamin D Deficiency Restless Let syndrome Pruritus Cervical Spondylosis Complex regional pain syndrome Anxiety Depression,,"Clarithromycin, Corticosteroids, Escitalopram, Topiramate Bupropion","['Circumstance or information capable of leading to medication error', 'Interchange of vaccine products']",1,MODERNA,IM 1046633,,53.0,F,"Tachycardia, palpitations, SOB, anxiety before, during and after injection. She did go to ER, symptoms resolved quickly.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/19/2021,01/19/2021,0.0,PVT,,,,,,"['Anxiety', 'Dyspnoea', 'Palpitations', 'Tachycardia']",1,PFIZER\BIONTECH,IM 1046634,CA,62.0,F,"Headache, bodyaches & pain or soreness at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,WRK,Tramadol-50 mgs. - for knee pain. Vit. D with Calcium,None,Arthritis,,Motrin,"['Headache', 'Injection site pain', 'Pain']",2,MODERNA,IM 1046635,SC,66.0,F,"After receiving the Moderna COVID 19 vaccine the pt. (while walking around in the store with her husband) began to feel dizzy and weak. She came back to the pharmacy area and she was seated and had her blood pressure checked. It was high (194/84) but she reported that she does have high blood pressure and takes her med at night. She was given a bottle of water, monitored and her blood pressure was checked twice again over the next 20 minutes. It read lower each time she was checked and when it read 156/84 she said she felt fine and was ready to leave with her husband. She also said she was diabetic and had eaten a small breakfast compared to normally. She will be contacted today to make sure she is still feeling ok.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PHM,Pt. did not indicate exact meds she was on but she said she takes blood pressure medication and oral medication for diabetes.,,Hypertension and Diabetes,,Thimerosal,"['Asthenia', 'Dizziness', 'Hypertension']",1,MODERNA,IM 1046636,NH,22.0,F,"12 hours after my second Moderna shot, had severe chest pain and shortness of breath. Admitted to emergency room later in the week for myocarditis as a result of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,PVT,Lamictal- 100 MG Trileptal- 300 mg AM 600 PM Prozac- 10 MG Birth control contraceptive,None,None,"After first moderna shot, vomiting, chills, body aches",Gluten,"['Blood test', 'Chest pain', 'Computerised tomogram', 'Dyspnoea', 'Electrocardiogram abnormal', 'Myocardial necrosis marker increased', 'Myocarditis', 'X-ray normal']",2,MODERNA,SYR 1046637,OH,68.0,M,"Felt dizzy, blurry vision, passed out, pale. Short of breath and vomited. RPh gave epinephrine which worked right away. Squad came and took to ED where he was observed for 4 hours. They did a chest xray, troponin, EKG, Lab work. Everything normal. Name of physician or treating hospital: ED- MD. Pharmacist advised not to get the 2nd dose. ED MD advised to get a 2nd dose. His MD told him to get the 2nd dose in a medical setting where he can be monitored.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/16/2021,0.0,PUB,"Lisinopril, Carvedilol, simvastatin, asa 81mg, fish oil",,"MI 18 years ago, prostate cancer 20 years ago, Hypertension well controlled, Bee allergy",,,"['Chest X-ray normal', 'Dizziness', 'Dyspnoea', 'Electrocardiogram normal', 'Laboratory test', 'Loss of consciousness', 'Pallor', 'Troponin normal', 'Vision blurred', 'Vomiting']",1,MODERNA,SYR 1046638,,79.0,M,"Administration error - Vaccine was under diluted, and patient received dose calculated to be approximately 25% more than recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Incorrect dose administered', 'Product preparation error', 'Product preparation issue']",2,PFIZER\BIONTECH,IM 1046639,MD,64.0,F,2? Oval red rash around injection site. Very itchy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/21/2021,7.0,PHM,Metoprolol.25 Multiple vitamins,N a,"Atrial tachycardia, sleep apnea, tendinitis",,"Cows Milk, cortisone,adhesive, floroquinolins ie Cipro","['Injection site erythema', 'Injection site pruritus', 'Injection site rash']",UNK,MODERNA, 1046640,CA,67.0,F,"On day 5 after injection my left upper arm itched a lot. By day 7 after injection, I noticed that left upper arm had a round raised red area around injection site that was swollen and inflamed and warm to touch. I took an ibuprofen before bed and had no trouble sleeping. This morning day 8 after injection, arm is still red, swollen and inflamed, but itching seems less. Otherwise, I have not had any other adverse side affects since receiving the injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/14/2021,02/21/2021,7.0,PHM,Atorvastatin Fluoxetine Calcium VitaminD Omega 3 fish oil Probiotic,None,None,"Penicillin, had trouble breathing went to ER and received shot of epi",Penicillin Sulfa,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Pruritus']",1,MODERNA,IM 1046641,MD,85.0,M,Patient hospitalized for sepsis due to UTI. Patient was treated with antibiotics and discharged,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/05/2021,02/11/2021,6.0,PVT,"Apixaban, diltiazem, escitalopram, finasteride, methenamine, mirtazapine, nitrofurantoin, olmesartan, polyethylene glycol, tamsulosin",,"Arthritis, atrial fibrillation, BPH, depression, hypertension, pulmonary emboli",,"cefuroxime (abdominal pain), quinolones (rash)","['Sepsis', 'Urinary tract infection']",2,MODERNA,IM 1046642,CA,32.0,F,"Syncope, went to urgent care .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/08/2021,3.0,WRK,"81mg aspirin, Metoprolol, Losartan, B12, Hyoscyamine",None,"Congenital heart defect, unspecified gastrointestinal problems",,None,"['Electrocardiogram', 'Haemoglobin normal', 'Syncope']",1,MODERNA,SYR 1046643,CO,27.0,F,"Nausea, vomiting, fever, chills, shaking, body aches, migraine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,PHM,Tylenol after vaccination,No illnesses,,,Latex and nuts,"['Chills', 'Migraine', 'Nausea', 'Pain', 'Pyrexia', 'Tremor', 'Vomiting']",2,MODERNA,IM 1046645,PA,63.0,F,"I developed chills on Friday, February 19, 2021 in the afternoon. Chills continued through Saturday, February 20, 2021. Did not feel well on Sunday, February 22nd and today, February 22nd, I woke up with a nice dose of shingles on my face. Went to see the nurse practitioner at Dr office. Not sure if this is a coincidence or a result of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/20/2021,2.0,PVT,"Atorvastatin, Lisinopril, Farxiga, Glimepiride, Metformin",none,diabetes,,shell fish,"['Chills', 'Herpes zoster', 'Malaise']",1,PFIZER\BIONTECH,SYR 1046646,MI,41.0,F,"Patient experienced numbness and tingling in throat.Onsite EMS was called Patient treated, Left aginst medical advice. BP 126/74 100% O2 HR 88",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,PUB,Synthroid,,,,,"['Pharyngeal hypoaesthesia', 'Pharyngeal paraesthesia']",1,MODERNA,IM 1046647,IL,47.0,F,"Loss of smell, high temperature of 104 degrees.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,WRK,Enchinea Beet Root Vitamin C,None,None,,None,"['Anosmia', 'Body temperature increased']",1,PFIZER\BIONTECH, 1046648,TN,88.0,F,"4 days after receiving the vaccine on 1/31, she experienced burning in her legs and feet; a few days later she had some SOB with activity (walking up stairs), lethargy and ""tired"" feeling in her arms and legs - all of these symptoms persist",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,02/04/2021,4.0,PUB,"Lisinopril, omeprazole, HCTZ, Simvastatin, diltiazem, low-dose ASA, multivitamin",none,"HTN, GERD, high cholesterol",,"morphine, codeine, NSAIDS","['Burning sensation', 'Computerised tomogram head normal', 'Dyspnoea', 'Electrocardiogram normal', 'Lethargy']",1,PFIZER\BIONTECH,IM 1046649,OR,38.0,F,"101 fever with acetaminophen and Ibuprofen, Chills, nausea, Myalgias, insomnia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,PUB,"Trazodone, unisom, Prenatal vitamin, Vitamin D, Fish Oil",none,none,,Septra,"['Chills', 'Insomnia', 'Myalgia', 'Nausea', 'Pyrexia']",2,MODERNA,IM 1046650,CA,46.0,F,"40-60 tender red bumps, mostly on torso.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/22/2021,1.0,PUB,None,Broken nose and treatment in ER,None,,None,"['Erythema', 'Rash', 'Tenderness']",1,PFIZER\BIONTECH,UN 1046651,OK,74.0,M,Extended pain at injection site and throughout arm and shoulder lasting until 02/21/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,PVT,Bupropion 300 mg Fenofibrate 160mg Pregabalin 300 mg Trajenta 5 mg Uloric 80 mg Vitamin d Aspirin Simvastatin Oxybutynin Ropinerole Furosemide Lisinopril,No,Diabetes Presence of pacemaker Arthritis History of renal complications,,NKA,"['Arthralgia', 'Injection site pain', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 1046652,CA,72.0,F,"tingling on top of her ears, headaches, possible rash on top of her hands that resembled prior history of contact dermatits",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,PVT,Ibuprofen,None,"dyslipidemia, stress/urge incontinences",,None,"['Headache', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 1046653,WI,68.0,F,"Got up the next morning after 1st vaccination with crusty eyes, itchy and watering. Self care till sunday 3rd day went to UC. Said I had pink eye. Gave medication. Later in the day started with fever, fatique, chills by day 5 after vaccination was told to get a Covid test which came back negative. They felt I had a late immune response. Was in good health for 2nd vaccination and the same thing happened with my eyes. Pink eye. We are 20 days out from 2nd vaccination and have pain in eyes, and watery. Spoke with Opthamologist office and they suggested 1st I try Refresh for 2 weeks if my eyes are not better will need to be seen. could be a response from the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,"diltiazem 60 mg x1 and 30mg hs, metoprolol 12.5mg, metformin 500mg x2, warfarin 5mg x1, crestor 12.5mg x 1, immipramine 75 mg hs, Klonopin 0.5mg hs, vitamins B-12, D3 x 2, calcium magnesium and zinc combined, vitamin C , Omega 3 1000iu x2",nothing,Prothrombin Gene Mutation Bladder augmentation Protein S deficiency Arthritis Pre diabetic Colostomy,,"Ketamine, Compazine, Latex, Bactrim, Ceftin, Cephalosporins, Droperidol, Reglan, Ondansetron, Phenergan, Sulfa drugs, Niacin, Lisinopril, Moxifloxacin, Omnicef,","['Chills', 'Conjunctivitis', 'Eye pain', 'Eye pruritus', 'Eyelid margin crusting', 'Fatigue', 'Immune system disorder', 'Lacrimation increased', 'Pyrexia', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 1046654,NJ,75.0,F,pt stated that she developed horrible itchy total body rash that she still has. She said it very itchy but slightly better today 2/22/2021. Pt contacted her allergist doctor and had a virtual appt. Pt was prescribed hydroxyzine and Zyrtec.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/16/2021,0.0,PVT,no,no,no,,"antibiotics, grass, dogs",['Rash pruritic'],2,MODERNA,IM 1046655,FL,70.0,F,"Intermittent Chills, Extremely tired. Lasted approximately 6 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/21/2021,6.0,PUB,"Glucosamine Chrondriton, Multi-Vitamin, Vitamin D3, Vitamin B12, Lutein, Ashwagandha, Guggul. Triphala, Shatavari, Calcium, Cod Liver Oil",None,None,"Loss of feeling in legs, 70, 02/15/21, Covid - Moderna",None,"['Chills', 'Fatigue']",UNK,MODERNA,SYR 1046656,PA,60.0,F,"Moderna vaccine administered as first dose but recorded as Pfizer-Biontech, resulting in the second dose being given as Pfizer-Biontech rather than Moderna.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,PVT,,,Primary Cancer of Right Upper Lobe of lung Malignant Neoplasm of Breast,,None,['Interchange of vaccine products'],1,MODERNA,IM 1046657,OH,41.0,F,"Received the vaccine Friday around 11:40 am. Arm was sore and had joint/body aches that evening. Saturday 2/20, 24 hours after getting the vaccine my tongue started to swell up/ was splotchy/ had bumps allong the side and my throat was scratchy. My breathing/asthma was also triggered and I increased use of my albuterol. I took benadryl with minimum results, but symptoms did not get severe enough to go to the ER. The next day, Sunday 2/21 my tongue was still swollen and my jaw/ face were also sore and had inflammation. This was in addition to the sore arm/joints.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,OTH,"Loratadine, cyclobenzaprine, lisinopril, lo loestrin, and amoxicillin taken the day before. Probiotic and Tylenol taken morning of vaccine. Albuterol as needed (had to increase use after vaccination.)",None,"Asthma, migraines, rosacea, history of sinus issues",Intense Migraines after flu shots in past,"Many medications cause me to get migraines, but have never had an allergic reaction to meds or food. Intolerance to MSG.","['Arthralgia', 'Asthma', 'Condition aggravated', 'Facial pain', 'Oropharyngeal discomfort', 'Osteitis', 'Pain', 'Pain in extremity', 'Pain in jaw', 'Rash macular', 'Swollen tongue', 'Tongue eruption']",1,MODERNA,IM 1046658,,47.0,F,"48 hours after the second dose of Pfizer COVID19 vaccine I started feeling very dizzy. I also felt very tired and sleepy, kind of getting a cold, with weird head ache. I almost never have head aches. I also experienced chills. Oddly, my husband got all the same symptoms very same day, as if I had 'infected' him with the vaccine. The feeling sick symptoms passed in about 2-3 days, but the weird stuffiness and some sort of pressure in my brain has stayed, and is annoying. I have not had this kind of head sensation before, and it is not going away. I have since had 2 negative covid RT-PCR tests.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/27/2021,2.0,PVT,Vitamin D,none,none,,none,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Nasal congestion']",2,PFIZER\BIONTECH,IM 1046659,CA,82.0,F,"Diarrhea next day, Sunday night around 7 pm. Bleeding on her pad like menstration. All better next day, except minor pain on lower stomach.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/21/2021,1.0,MIL,,,,,Diarrhea by 7 pm next day Sunday night . Pressure and pain on lower stomach.,"['Abdominal discomfort', 'Abdominal pain upper', 'Diarrhoea', 'Vaginal haemorrhage']",UNK,PFIZER\BIONTECH, 1046660,OK,70.0,F,Hypercalcemia AKI encephalopathy acute vomiting fatigue acute ER 2/15 ICU 2/15 Hospitalized till 2/2021 IVs extensive electrolyte medications,Not Reported,,Yes,Yes,6.0,Not Reported,N,02/11/2021,02/12/2021,1.0,PUB,cholsteroff multivitain Calicum 4800 mg D3 75 Aspirin 325 rosuvastatin 40 mg fenofibratw 145 mg vascepa 4 gm ibandronate 150 mg niacin Er1000 edarbyclor 40/12.5 cedarbi 40 mg,No,no,,penicillin,"['Acute kidney injury', 'Encephalopathy', 'Fatigue', 'Hypercalcaemia', 'Intensive care', 'Vomiting']",2,PFIZER\BIONTECH,IM 1046661,WV,55.0,F,"Within 30 minutes after having the vaccine, she felt a thickness in her throat and then had trouble swallowing. She reported this to the authorities. They took her vitals which showed that her oxygen saturation was 99%, heart rate was 78 and blood pressure was normal. They eventually let her go home. She was not given any Benadryl or any other medications. The following day on February 13, she was fine. Later on that day, she developed some sudden onset of itching from the neck up. Even the insides of her ears were itching. This lasted 3 to 4 hours and then disappeared by itself. On February 14th and 15 she said she was suffering from the usual side effects expected from the vaccine including fatigue and a low-grade fever of 99.6 but these again went away by themselves. The following week, on February 17, she developed more generalized itching all over her body including feet legs and everywhere. It was similar to the itching that she had developed when she was allergic to sulfa medication. Discontinued on Thursday. Now she continues to have some itching but not as bad as on the 17th and 18th.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,PVT,Bupropion 150 mg Famotidine 20mg Fluoxetine 10mg levothyroxine 125mcg Loratadine 10mg Multivitamin,"She stated that she felt anxious, clammy and sweaty prior to getting to the appointment for her vaccination.",Graves disease Hypothyroidism folate deficiency Vit d deficiency b12 deficiency anxiety,,Aspirin Sulfa Bupropion NSAIDS Penicillin Bee Venom,"['Dysphagia', 'Fatigue', 'Pruritus', 'Pyrexia', 'Throat tightness']",UNK,MODERNA, 1046662,ID,91.0,M,"Nurse did not reconstitute vial. Patient was accidentally given entire contents of vial equaling 6 doses. Patient was admitted as a precaution for observation on Saturday, 2-20-2021, due to complaint of chills. Patient was discharged on Sunday, 2-21-2021. Patient currently reports no side effects.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/19/2021,02/20/2021,1.0,OTH,,,"Hyperlipidemia, hypertension, aortic valve stenosis, GERD, CHF, thyriod atrophy, skin cancer",,No,"['Chills', 'Extra dose administered', 'Incorrect dose administered']",1,PFIZER\BIONTECH,IM 1046663,KY,66.0,F,Shot was administered on Monday. Itching and red rash broke out on Saturday. Lasted about 3 days. Used topical spray (Calamine Plus Itch Relief),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/13/2021,5.0,PUB,1 - Centrum Silver Multivitamin 1 - Nature Made Calcium 500 mg 1 - Atovasatin 20 mg.,None,None,,"Cipro, Bactrim, Clindamayacin","['Pruritus', 'Rash erythematous']",1,MODERNA,SYR 1046664,MD,69.0,M,Patient was admitted for a descending colon perforation and contiguous large abscess. Patient underwent drainage and improved and was eventually discharged,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/09/2021,02/11/2021,2.0,PVT,"acetaminophen, aspirin, cipro, ibuprofen, lisinopril, Tamsulosin, MVI",,"Bowel obstruction, hypertension",,NKA,"['Abscess', 'Abscess drainage', 'Large intestine perforation']",1,PFIZER\BIONTECH,IM 1046665,VA,23.0,F,"painful, erythema, swelling, knot on left arm. Dyspnea, chest tightness, wheezing, feeling of swelling in throat, struggling to breath on the 6th and went to ED. Fever 104. CT scan, ultrasound of arm, Oxygen and nebulizer treatments beta agonists, +diphenhydramine. Prednisone+azithromycin+benzonatate+prn rescue inhaler (albuterol). As of 2/22 still using treatments and still having symptoms as an outpatient. Assessment for emboli.",Not Reported,,Yes,Yes,2.0,Yes,N,02/03/2021,02/06/2021,3.0,WRK,"Symbicort, buspar, seroquel, omeprazole, singular",,"Asthma, GERD",,"clindamycin(rash), latex (rash","['Chest discomfort', 'Computerised tomogram', 'Dyspnoea', 'Erythema', 'Limb mass', 'Nodule', 'Pain in extremity', 'Peripheral swelling', 'Pharyngeal swelling', 'Pyrexia', 'Ultrasound Doppler', 'Ultrasound scan', 'Wheezing']",1,MODERNA,IM 1046666,OK,92.0,M,"Patient had no adverse events during the observation period after vaccine. He was conscious and having conversation with facility staff. He was observed for 15 minutes at least. When the facility staff returned later, approximately 60 to 90 minutes, patient had passed away.",Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,SEN,,None,Heart and artery diseases,,KNDA,['Death'],2,PFIZER\BIONTECH,IM 1046667,NV,45.0,F,"Severe headache, severe body aches and pains, fever, rash behind neck, left arm very red swollen very hot, red left eye, diarrhea, runny nose, voice seems very harsh now, burning sensation in the back of neck, severe throbbing stabbing pains in my legs, nauseous, dizzy,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,OTH,My high blood pressure medication,,,,"Ceftin, keflex","['Burning sensation', 'Diarrhoea', 'Dizziness', 'Dysphonia', 'Erythema', 'Headache', 'Nausea', 'Ocular hyperaemia', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Rash', 'Rhinorrhoea', 'Skin warm']",2,MODERNA,SYR 1046668,MI,61.0,F,"Chills, Body Aches",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/30/2021,01/30/2021,0.0,SEN,,,,,,"['Chills', 'Pain']",UNK,MODERNA,IM 1046669,CT,65.0,F,"Seven hours after shot, while lying in bed, had pounding and racing heart for 2.5 hours. Did not call doctor because it was in the middle of the night and racing did stop. Now, continue to feel weak and fatigued, 70 hours after shot. Spoke to doctor's office this morning. Advised me to keep hydrated and take Tylenol if needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,PUB,magnesium Vit. D,,,,steriod eye drops,"['Asthenia', 'Fatigue', 'Palpitations']",1,MODERNA,SYR 1046670,WI,70.0,M,Pt received first dose of COVID-19 vaccine on 2/12/2021. Pt presented to ED 2/18/2021 with shortness of breath and confusion. He reported having an exposure to someone positive for COVID-19 prior to date of vaccination but was unaware of exposure until after. Pt had findings indicating pneumonia on chest X-ray and required supplemental O2 with admission to hospital (2/18/2021). Pt was discharged the evening of 2/21/2021.,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/12/2021,02/18/2021,6.0,PHM,"Amlodipine, atorvastatin, biotin, calcitriol, cholecalciferol, gabapentin, glucosamine-chondroitin, multivitamin, terazosin.",,"Sacroiliac pain, lumbago, hyperlipidemia, diverticula of colon, coronary atherosclerosis, colon polyp, BPH, arthritis",,No known allergies,"['COVID-19', 'COVID-19 pneumonia', 'Chest X-ray abnormal', 'Confusional state', 'Dyspnoea', 'Exposure to SARS-CoV-2', 'Pneumonia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1046671,WA,66.0,F,"24 hours post injection: Chills, fever (102 F), pain at injection site, nausea, fatigue, body and joint aching, Side effects gone after 36 hours, except sore arm, which lasted 2 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PVT,levothyroxine,,,,"penicillin, sulfa, cechlor, seldane","['Arthralgia', 'Chills', 'Fatigue', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,IM 1046672,NC,64.0,F,"Patient initially described superficial itiching of hands. Upon observation, was scratching all over her torso and arms as well as neck. Benadryl 50 mg provided with improvement in superficial itching but endorsed internal abdominal itching and continues to touch her throat.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/20/2021,0.0,SCH,Oxycodene Q2 x 12 hours,Back pain,Back Pain,Flu,"Shellfish, PCN, MSG, Aspirin","['Blood glucose', 'Pruritus', 'Tenderness']",UNK,PFIZER\BIONTECH,IM 1046673,MD,35.0,F,"Reports sensation of tingling and puffiness of lips starting about 2 hours after immunization, which was still present the next morning. She did not visualize any change in her lips, and did not tell anyone about the reaction until it was time for her 2nd dose. She had previously tested positive for COVID in September and was not given a 2nd dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PUB,"Zyrtec, Claritin, Flonase, Nexium, Prevacid, OTC Stool softener",None,GERD Nephrocalcinosis,,Latex Oral allergy syndrome,"['Lip swelling', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 1046674,TX,87.0,F,"About 6 day later, she developed a low grade fever (99.6), headache, her chest was feeling heavy and tight, she was achy all over, she had chills. She had a horrible cough (deep, barky cough, non productive cough) Her symptoms continually got worse. She also had an earache. She was having trouble breathing so we went to the ER on 02/16/2021. They diagnosed her with bilateral pneumonia and fluid on both of her lungs. She was discharged from the ER same day under my care, I am an RN. The prescribed her a Zpack (Azithromycin) 500 MG for 1 day, the next 4 days 250 MG, Naproxen 500 MG every 12 hours, Albuterol nebulizer treatments every 4 hours. ER doctor believes that the vaccine may of effected her immune system. She does have a follow up with Dr. on March 2nd. She is improving. She still has a mellitic/bitter taste in her mouth from the first vaccine. She is doing better but not completely over it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/12/2021,6.0,PVT,"Flexeril 10 MG daily, Lexapro 10 MG twice a day, Aspirin 81 MG daily, Claritin 10 MG twice a day, Multi-vitamin gummy (2 gummies daily), Vitamin C gummy (2 gummies every day), Prilosec 40 MG daily Eye drops prescribed after the first dos",,"Allergies, back pain, previous back surgery, carpal tunnel syndrome, Osteoarthritis","Yes a VAERS report was filed on 2/22/2021, e-confirmation number 316044","Penicillin, Vinegar, Cheyanne pepper, Prednisone","['Chest X-ray abnormal', 'Chest discomfort', 'Chills', 'Cough', 'Dysgeusia', 'Dyspnoea', 'Ear pain', 'Electrocardiogram abnormal', 'Full blood count abnormal', 'Headache', 'Laboratory test abnormal', 'Myocardial necrosis marker increased', 'Neutrophil count abnormal', 'Pain', 'Pneumonia', 'Pyrexia', 'Urine analysis abnormal', 'White blood cell count abnormal']",2,PFIZER\BIONTECH,IM 1046675,OH,96.0,M,Received the vaccine in the morning and came to ER later post fall. he was admitted with a fracture and later transferred to a higher level of care hospital,Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/11/2021,02/11/2021,0.0,PVT,,,CHF,,Iodine contrast,"['Fall', 'Fracture']",2,PFIZER\BIONTECH, 1046676,MI,60.0,F,"Temp, body aches, chills, headache, dizzy, (L) arm very painful, swollen",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/30/2021,01/31/2021,1.0,UNK,,,,,,"['Chills', 'Dizziness', 'Feeling of body temperature change', 'Headache', 'Pain', 'Pain in extremity', 'Peripheral swelling']",UNK,MODERNA,IM 1046677,IN,68.0,F,"Eighteen days after receiving the shot, I noticed a large, red blotch area around the vaccination site on my left arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/22/2021,18.0,PUB,"Levoxyl Currently undergoing chemotherapy - date of infusion previous to vaccine was January 19, 2021",Ovarian Cancer,Ovarian Cancer,,Benadryl - infusion of Amoxicillin,"['Injection site erythema', 'Rash macular']",1,MODERNA,IM 1046678,AZ,77.0,F,"This was my second vaccination at the same site. I was fine with the first shot, and seemed fine with the second one until the next afternoon around 3:00 p.m. All of a sudden I could feel some aching in the back of my neck and just a feeling of aching down my back. Then I started to get the chills, chills that were so bad my body was almost convulsing with chills. I ended up going to bed and I turned my electric mattress pad on to warm up. I then slept very well and I don't think I moved all night. I woke up sort of achy, but not much to be concerned with.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/22/2021,1.0,PVT,"Doxycycline, 20mg., Estradiol, prevastatin 50 mg.",none,"Rosacea, Raynauds,",,none,"['Back pain', 'Chills', 'Neck pain', 'Pain']",1,PFIZER\BIONTECH,SYR 1046679,OH,56.0,F,"warm to touch ,redness and swelling of entire deltoid and below injection site , itching of arm .Took 2 Benadryl, Same reaction happened after first vaccination but not as significant. Second vaccination symptoms have worsened. I have not required further medical treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/21/2021,2.0,UNK,,,,,,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Pruritus']",UNK,MODERNA,IM 1046680,OK,49.0,F,"Facial drooping, watering of the right eye, twitching of the right eye. Diagnosed as Bell's Palsey. Rx for prednisone.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/19/2021,17.0,SEN,"Synthroid, and HCTZ",none,Hashimoto's,,Cephlasporins,"['Blepharospasm', 'Blood potassium normal', 'Facial paralysis', 'Lacrimation increased']",2,PFIZER\BIONTECH,IM 1046681,MI,27.0,F,Patient experienced generalized anxiety disorder. Onsite EMS was called vitals BP 149/93 100% O2 room air HR 84 Patient refused evaluation/care released against medcial advice.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,02/09/2021,0.0,PUB,,,,,,"['Blood pressure increased', 'Generalised anxiety disorder']",1,MODERNA,IM 1046682,HI,32.0,M,Left arm and facial numbness starting 2/14/21 and lasting 10 min. I had two episodes one week apart.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,02/14/2021,24.0,PUB,"Left hand numbness radiated to elbow. Left facial numbness, left tongue numbness. Numbness lasting 10 min. I have had two episodes. I had another episode yesterday 2/21/21 at 630 am. Numbness lasting 10 min. I went to the ER and had a head",none,none,,none,"['Computerised tomogram normal', 'Hypoaesthesia']",2,MODERNA,SYR 1046683,CA,40.0,F,fatigue low grade fever 100.9 chills nausea lasted for 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/20/2021,01/20/2021,0.0,UNK,,,,,,"['Chills', 'Fatigue', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1046684,MN,46.0,F,"L arm pain, HA, body aches/chills starting 12/29/2020. Chest pain, SOB, cough, fevers starting 1/3/2021. Hemoptysis 1/7/2021 with worsening SOB and positional cough. Multiple PEs found on chest CT 1/10/2021 and hospitalized on heparin drip for >24hrs. DVT found on lower leg US 1/10/2021. Remain on DOAC for anticoagulation.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/28/2020,01/03/2021,6.0,PUB,"Vitamin C, xyzal PRN",none,polycythemia,,Vicodin Environmental allergies,"['Anticoagulant therapy', 'Chest pain', 'Chills', 'Computerised tomogram thorax abnormal', 'Condition aggravated', 'Cough', 'Deep vein thrombosis', 'Dyspnoea', 'Haemoptysis', 'Headache', 'Injection site pain', 'Laboratory test', 'Pain', 'Pulmonary embolism', 'Pyrexia', 'Ultrasound scan abnormal']",1,MODERNA,IM 1046685,,63.0,F,"After 7 hours after the injection, the injection site was itchy. It was not swollen or red, but there was an itchy, tingling sensation. A week later the injection site was swollen, red, and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/14/2021,0.0,PHM,,na,na,,nkda,"['Injection site erythema', 'Injection site paraesthesia', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 1046686,NY,70.0,F,"5min after vaccine as per daughter, her mother began complaining of ""burning "" in her chest , itching in her throat, lump in her throat, hives/redness noted on throat and chest. RRT responded and accompanied patient to ED",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,PVT,,,,,,"['Chest pain', 'Erythema', 'Sensation of foreign body', 'Throat irritation', 'Urticaria']",2,PFIZER\BIONTECH,IM 1046688,NE,74.0,M,"(L) lower extremity pain, patient seen in office 2/19/2021, pt started on Eliquis",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/14/2021,2.0,PVT,"Tylenol 500mg, Aspirin 81mg, Clopidogrel 75mg, Metoprolol Tartrate 25mg 0.5 tab daily, MTV, Nitroglycerin 0.4mg, Pantoprazole 40mg BID, Crestor 20mg, CoQ10 300mg",none known,"AAA, biliary dyskinesia, CAD, hyperlipidemia, pulmonary nodules, skin cancer",,"Flagyl, PCN, pravastatin","['Angiogram', 'Anticoagulant therapy', 'Pain in extremity', 'Ultrasound Doppler']",1,PFIZER\BIONTECH,IM 1046689,AK,32.0,M,2-3hrs after the vaccine I started feeling pain in my lungs it was a 6 or 7 out of 10 pain. I also had arm soreness. My lung pain started getting better day by day but I still have a little pain here and there. I saw my doctor on base we did breathing treatments it was like Asthma treatment.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,MIL,,,,,,"['Pain in extremity', 'Pulmonary pain']",1,MODERNA,SYR 1046690,AZ,49.0,F,Dizziness started with 1st injection on Dec 22nd and got worse with second injection on Jan 21st. Has subsided but it is not gone. Persists to current day. Muscle Aches within 12hrs of injection for a duration of 4 days Nausea within 4 hrs of injection for a duration of 24hrs Pain at the injection site within 12hrs of injection for a duration of 7 days Burning skin within 12hrs of injection for a duration of 48hrs Sore joints within 12hrs of injection for a duration of 48hrs,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/22/2021,1.0,PVT,B Complex Vitamin C Vitamin D3 Zinc Turmeric,No,None,See above Item 22 and have also filed a report for prior on Vaers,None,"['Arthralgia', 'Dizziness', 'Injection site pain', 'Myalgia', 'Nausea', 'Skin burning sensation']",2,MODERNA,IM 1046691,AZ,75.0,F,Severe shaking during teh night with chest congestion and headache. Resolved by teh following day at 3pm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PVT,"Developed chills developed at 1800, then developed violent shaking, chest congestion. Then had a cough at night. Had a Heaache, resolved by the next day at 1500.",None,NOne.,,NOne,"['Headache', 'Pulmonary congestion', 'Tremor']",2,PFIZER\BIONTECH,IM 1046692,NV,31.0,M,"within 12 hours had a reaction to include significant shakes and chills. After a period of respite patient developed chest pains, was admitted to hospital on 14FEB, and diagnosed as having had a Type 2 heart attack.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/10/2021,02/12/2021,2.0,MIL,,,,,,"['Acute myocardial infarction', 'Chest pain', 'Chills', 'Tremor']",2,MODERNA,IM 1046693,NY,63.0,F,"On 2/19/21 was just the slightest headache, and tired. Took 2 Tylenol and was in bed by 10. On 2/20/21 still a slight headache, took 2 Tylenol then went out and walked about a mile, visited family, then walked back home. By the time I got home I was barely able to walk up the stairs. Felt exhausted and nauseous. Slept for a few hours and got up and just sat on the couch for another few hours and then felt that same nausea and exhaustion and went to bed. Took 2 more Tylenol. Started drinking more water. On 2/21/21 felt pretty good -- stayed in all day -- ate a little -- but saw the site on my arm just under the injection site was very large, red, and hot to the touch. The red welt area went from just below the injection in the left arm to just above the elbow. On 2/22/21 (today) feel pretty good. Drinking a lot of water and tool 1 Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,OTH,Lorsartan Potassium (25 mg daily); Atorvastatin (10 mg daily); Iron (65 mg daily); B-12 (1000 mcg daily) -- and usually COQ10,No,No,,Possible allergy to penicillin - but never confirmed,"['Fatigue', 'Gait disturbance', 'Headache', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Nausea', 'Urticaria']",2,MODERNA,SYR 1046694,GA,56.0,F,"Swollen, sore, itchy patch at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/18/2021,5.0,PHM,"Losartin, water pill, estrogen",,Asthma,,,"['Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 1046696,GA,86.0,M,"psoriasiform eruption at lower buttock and inner thighs- never with similar rash in past. raised, red, serpiginous + annular lesions with silvery/white, rough scale at surface.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/13/2021,10.0,PUB,"losartan, finasteride, gabapentin, cholestyramine, diltiazem ER, atorvastatin",none known,"elevated cholesterol, HTN, irritable bowel syndrome, BPH, eczema (on occasion)",,NKDA,"['Dermatitis psoriasiform', 'Rash erythematous', 'Rash papular']",1,MODERNA,IM 1046697,KY,76.0,M,1st vaccine 2/10/21; developed chest pain 2/21/21; seen at ED and admitted to Hospital 2/22/21 for chest pain.,Not Reported,,Not Reported,Yes,,Not Reported,N,02/10/2021,02/21/2021,11.0,PVT,,,Multiple; see chart,,Ciprofloxacin; Flagyl,['Chest pain'],1,PFIZER\BIONTECH,IM 1046698,,63.0,M,patient passed away within 60 days of receiving a COVID vaccine,Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,,01/26/2021,02/20/2021,25.0,SEN,,,,,,['Death'],1,MODERNA, 1046699,AK,83.0,F,"One hour after second injection on 2/17, felt a little 'out of it', then redness at injection site. 3"" by 4"" area of redness, warmth, stiffness and soreness at shoulder.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PUB,Simvastatin 20mg 1/daily Glucophage 4 daily,None,type 2 diabetes,,codeine,"['Feeling abnormal', 'Injection site erythema', 'Injection site pain', 'Injection site reaction', 'Injection site warmth', 'Musculoskeletal stiffness']",2,MODERNA,IM 1046700,NE,61.0,F,"Nurse and patient unsure if there was actually vaccine in syringe used to give shot. Nurse noticed after injecting into left deltoid that syringe plunger was already pushed in and didn't notice any vaccine in syringe. No side effects or reactions following ""injection"". Nurse called manufacturer for guidance--- following up with pt as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,OTH,NONE,NONE,NONE,,NONE,"['Device dispensing error', 'Incorrect dose administered']",2,MODERNA,IM 1046701,CA,34.0,F,itchy eye watering eye all around eyes were watering and itchy they are swollen and puffy,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,UNK,,,,,,"['Eye pruritus', 'Eye swelling', 'Lacrimation increased', 'Periorbital swelling']",2,MODERNA,SYR 1046703,MI,29.0,F,"The day I received the shot there was some pain and a hive appeared. It was about .5 inch thick and 1.5-2 inches long at the injection site. I got the shot on Friday and by Monday afternoon those symptoms had disappeared. Nine days after receiving the shot (about 5 days after reaction disappeared) the same reaction came back. The bump does appear to be a hive. I have not seen a doctor about this, I have not had insurance and have not recently been to the doctor. It is swelled and is very itchy but there is no arm pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/21/2021,9.0,OTH,None,"Stuffy nose and sore throat about a month prior. Tested negative for COVID 19 around the same time. The day that I originally got the vaccine I had some arm pain near the injection sight, and a similar red hive appeared. Both symptoms were gone by Monday afternoon.",None that I am aware of.,,None that I am aware of.,"['Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria']",1,MODERNA,SYR 1046704,GA,68.0,F,"In about 12 hrs I felt fevered, then went to cold, then I started trembling. So hard, I still felt cold, but this wasn?t shivering, I wanted to go to get in warm water. I was shaking so bad I couldn?t take my clothes off. I got in with clothes on, I was getting delirious. My whole body was contracting so hard I couldn?t sit in the tub flat, my but cheeks contracting with all muscles. I found myself in the night with a sticking hat soaked in water to cover my face. I could not have called for help when the muscle contractions were going on. That lasted I think 30-45 minutes. I was groggy on the 20th all day but getting much better. I was very excited for vaccine and would do it again, but wanted to report what I consider pretty rough side effect, so you could make note of it. And I still thank you for the vaccine, but dang I truly thought I was dying.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PUB,"Air Borne Supplement, aspirins, Advil for Sinus",No,No,,No,"['Chills', 'Delirium', 'Feeling cold', 'Muscle contractions involuntary', 'Pyrexia', 'Somnolence', 'Tremor']",2,MODERNA,IM 1046705,HI,35.0,M,"urticaria beginning approximately 24-36 hours after vaccination, affecting bilateral upper and lower extremities and trunk. Predominantly peripheral distribution of concentrated urticarial lesions. No angioedema/anyphylactic sxs. Treated with Benadryl prn with improvement.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/18/2021,1.0,MIL,,"Cellulitis, finished antibiotic course of Septra 14Feb2021",None,,None,['Urticaria'],UNK,PFIZER\BIONTECH, 1046706,MA,64.0,F,Swelling in muscle near injection site followed by red rash with mild discomfort . Rash still present,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PHM,Rouvastatin Vitamin D Vitamin B12,GERD,None,,Pseudophedrines,"['Discomfort', 'Injection site swelling', 'Rash erythematous']",UNK,MODERNA,IM 1046707,TX,46.0,F,"Received Moderna vaccine on 2/9. Developed a rash 5-6 days later at the injection site. Over time the rash has gotten larger and developed white bumps. Tenderness. +Itching. Works as a police and fire dispatcher. At time of visit: Localized erythema of the left upper arm at injection site of Moderna COVID-19 vaccine Recommend applying cool compress, aloe vera gel, topical benadryl, or hydrocortisone cream to relieve irritation and itching Benadryl as needed for itching Tylenol or Motrin as needed for pain relief Follow-up as needed",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/19/2021,10.0,OTH,"Tizanidine, Bystolic, Ibuprofen, Lisinopril",None,Hypertension and Asthma,,"Demerol, Sulfa drugs","['Injection site erythema', 'Injection site rash', 'Pruritus', 'Tenderness']",UNK,MODERNA, 1046708,DC,67.0,F,"MODERNA COVID-19 Vaccine EUA On 2/4/21 I received my vaccination in my left arm. On 2/16/21 noticed a red hive like rash at the injection site that extended down to the inside of my arm. No bumps, not itching, just a red patch about the size of a half of chicken breast. Applied Triamcinolone cream to the site. Saw Dr. on 2/17/21 and she said to monitor and apply the Triamcinolone cream. If it worsened we may treat it as a skin infection. The redness lessened over the next few days and was gone by 2/21/21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/16/2021,12.0,PVT,"Fluticasone propionate Naproxen 500mg Joint formula supplement, Kelp tablet Floragen, Vitamin C Calcium with Vitamin D, Zicam",None,None,,Augmentin possibility of skin reaction to Cocoa Butter,"['Injection site erythema', 'Injection site reaction', 'Rash erythematous', 'Urticaria']",1,MODERNA,SYR 1046709,MI,48.0,F,"Chills, body aches, fever, Vomitting",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/30/2021,01/31/2021,1.0,SEN,,,,,,"['Chills', 'Pain', 'Pyrexia', 'Vomiting']",UNK,MODERNA,IM 1046710,OR,22.0,M,"SOB after vaccine administration. lasted 4-5 min, resolved after taking off mask",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,"Lisinopril. insulin,",unknown,"MS, Diabetes , autisim",,unknown,['Dyspnoea'],2,PFIZER\BIONTECH,IM 1046711,AZ,66.0,F,"Fever, weak, dizzy, vomite, no appetite",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,WRK,"Metform, Glipizide, Montelukast Sod., Triamt/HCTZ, Metroprolol, Pantoprazole, Oxbutynin, Isosorb, Linsinopril",None,"Diabetes, heart disease, asthma",,Penicillin,"['Asthenia', 'Decreased appetite', 'Dizziness', 'Pyrexia', 'Vomiting']",UNK,MODERNA, 1046712,OH,71.0,F,"Red area approximately 2 x 2 inches, no itching, no pain, lasted approximately 36 hours. Similar to ""Covid Arm"" described online. No other adverse effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/12/2021,8.0,PHM,"Lisinopril, Femara, Metformin, Simvastatin, Calcium, Vitamin D. Culturelle",N/a,"Hypertension, Type II Diabetes, controlled",,,['Erythema'],1,MODERNA,IM 1046714,FL,74.0,F,8 days after shot arm is red warm and itchy where shot was given,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/13/2021,02/21/2021,8.0,PVT,baby aspirin 20mg lovastatin probiotic gummy fiber gummy calcium 900,nonenn,none,"chills for 2 days following shingles shots, 1st and 2nd",none,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,SYR 1046715,MO,69.0,F,"Blood surges not controlled, slept ca 24/7, tired, felt out of place r kilter",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/20/2021,2.0,PHM,"Bydureon exenatide suspect. ER, duloxetine 60 mg cap x1, ezetimibe 10 mg tab x1, ferrous sulfate etc. 325 tab 2x 1, moving sliding scale, levothyroxine 112 mg tab x1 linagliptin 5 mg tab x1, valsartan 100 mg tab x1, metoprolol succinate,xl","Diabetes, high blood pressure kidney problems high cholesterol joint disease",,,"Sulfa, coconut, strawberry","['Fatigue', 'Feeling abnormal', 'Somnolence']",UNK,MODERNA, 1046716,GA,30.0,F,Fine for hour or so then began to lose voice slowly over the next few hours and cough. Shortness of breath from simply walking around swelling of the glands and consul in the neck and throat,Not Reported,,Yes,Yes,1.0,Not Reported,N,02/11/2021,02/11/2021,0.0,OTH,Paxil 40 Singular 10 Vyvanse 60 Propranolol Er 60,None,None,,None,"['Anaphylactic reaction', 'Aphasia', 'Aphonia', 'Cough', 'Dyspnoea', 'Dyspnoea exertional', 'Fatigue', 'Fear', 'Insomnia', 'Lymphadenopathy', 'Malaise', 'Pharyngeal swelling', 'Tonsillar hypertrophy', 'Tonsillitis']",2,PFIZER\BIONTECH,SYR 1046717,,58.0,F,"stiff jaw, but also had a recent dental appointment. Not sure which it is from.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/20/2021,01/21/2021,1.0,PVT,,,,,,['Joint stiffness'],UNK,MODERNA, 1046718,MD,69.0,F,"Patient was admitted after having a syncopal episode. After evaluation by cardiology and neurology, patient was discharged",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/04/2021,02/12/2021,8.0,PVT,"calcium-vitamin D, MVI, cetirizine, aspirin, diltiazem, hydrochlorothiazide, krill oil, losartan, magnesium gluconate, metoprolol succinate",,"Hx of brain aneurysm, hypertension, celiac disease, osteoporosis",,"gluten (celiac disease), penicillins (hives, swelling), latex (unknown), lisinopril (cough)",['Syncope'],1,MODERNA,IM 1046719,PA,69.0,F,"On day 9 after the shot the area around the injection site became very itchy and warm and shortly after a rash started appearing. I used topical hydrocortisone cream and Caladryl. The rash ended up being about 2"" x 3"" in size. It felt slightly sore but not much. I took pictures if you want them. After few days I took a Benadryl product as my whole body started feeling slightly itchy off and on but I think thats just from being nervous about arm rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/19/2021,9.0,OTH,Armour Thyroid,none,none,Tdap vaccine- just a sore arm.,none,"['Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth', 'Pruritus']",1,MODERNA,IM 1046720,,25.0,M,"fatigue, chills, felt f",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/21/2021,01/22/2021,1.0,PVT,,,,,,"['Chills', 'Fatigue']",UNK,MODERNA, 1046722,WY,67.0,M,"No symptoms or signs on the day 1st dose of vaccine was received (2/11/2021). 3 days later, (2/14/2021) patient experienced chills for approximately 6 hours, followed by severe (visible) chest spasms, and then cardiac arrest. 911 was called upon witnessing chest spasms, but cardiac arrest/death occurred before patient could be transported to the hospital.",Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/14/2021,3.0,PVT,,UTI,Congestive Heart Failure,,,"['Cardiac arrest', 'Cardiac disorder', 'Chills', 'Death', 'Diaphragmatic spasm', 'Toxicologic test']",1,PFIZER\BIONTECH,IM 1046723,FL,65.0,F,"Sciatica nerve pain throbbing constantly from left butt down left leg to my calf. Started February 16th, strong pain (just bearable). Starting February 20th, pain slightly subsided and just painful during walking. Starting February 22nd (today), slightly less painful. I am hoping this is not permanent...",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/16/2021,2.0,PHM,none,none,Back surgery in 2015,,Allergic to Cyclobenzaprine and Flexoril muscle relaxant Cephalosporin antibiotic,"['Pain', 'Sciatica']",1,MODERNA,IM 1046724,CO,26.0,F,"daily episodes of rapid heart rate, elevated blood pressure, chills, sweating, shaking, dizziness, light-headedness, brain fog",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,WRK,Sertraline 50mg,None,none,,None,"['Blood pressure increased', 'Blood test', 'Cardiac monitoring', 'Chills', 'Dizziness', 'Feeling abnormal', 'Heart rate increased', 'Hyperhidrosis', 'Laboratory test', 'Scan', 'Tremor']",2,MODERNA,SYR 1046725,,71.0,F,arm was erythematous and itchy.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/20/2021,01/22/2021,2.0,PVT,,,,,,"['Pruritus', 'Rash erythematous']",UNK,MODERNA, 1046726,OH,72.0,F,"left deltoid raised red 4"" across arm and 1.5 "" high itchy (very). Warm to touch, today getting larger and as not as red, warm to touch. will contact dr if starts to get larger.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/13/2021,02/21/2021,8.0,UNK,"atorvastatin, valacyclovir, ometrosval, gabapentin, 81 asp, meloxicam",no,"arthritis, high cholesterol",,"tetralin rash, Levaquin, polypore, band aid","['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 1046727,CA,85.0,M,Severe hallucination after the second dose,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/17/2021,02/18/2021,32.0,UNK,"Aspirin , Mirapex ,azelaic , Methyldopa , over all Parkinson medicine",Parkinson,,,,['Hallucination'],2,MODERNA,SYR 1046728,PA,65.0,F,Rapid heartbeat of 135 bpm Blood pressure 176/110 No treatment Symptoms resolved themselves after 1 hour,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PHM,Vitamin C and D; Iron,None,None,,Sulfa; MACROBID,"['Electrocardiogram', 'Heart rate increased']",UNK,MODERNA,IM 1046729,,23.0,F,stomach muscle aches.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/21/2021,01/22/2021,1.0,PVT,,,,,,['Abdominal pain upper'],UNK,MODERNA, 1046730,CA,29.0,F,"Symptoms 01/24/2021- numbness, weakness, tingling bilateral legs. Lost inability to walk and bladder control Admitted to hospital 01/24/2021-1/26/21. Not diagnosed. Had 4 MRIS and a lumbar puncture 02/3/2021- was in ED at hospital due vision issues/double vision- discharged same day. Repeated 4 MRIS and blood work, and lumbar puncture. 02/09/2021- patient was seen at a neurologist, due to numbness in bilateral hands and arms. And was admitted to Medical Center until 02/13/2021. Ruled out MS, GB, repeated 4 MRIS and LP. Was sent home with home health and PT. Saw PCP 02/19/2021, Did paperwork for disability and removed from work until 04/30/2021. PCP ordered more blood work up to 35 tubes of blood done on 02/17/2021. Will not be ready until 14 days post draw. Patient is still complaining of tingling on bilateral hands and feet, and weakness. Mainly sensory nerves related symptoms.",Not Reported,,Not Reported,Yes,2.0,Yes,N,01/05/2021,01/24/2021,19.0,UNK,,,,,,"['Asthenia', 'Blood test', 'Diplopia', 'Gait inability', 'Hypoaesthesia', 'Impaired work ability', 'Lumbar puncture', 'Magnetic resonance imaging', 'Magnetic resonance imaging normal', 'Muscular weakness', 'Paraesthesia', 'Urinary incontinence', 'Visual impairment']",1,PFIZER\BIONTECH,IM 1046731,AZ,57.0,F,Patient was complaint of feeling itchy to chest and right arm following administration of vaccine. No redness was seen to chest and only redness to right arm was where there were two red scratch lines to arm. Denied any shortness of breath or edema. After a few minutes patient stated that she was starting to feel better. Patient wanted to go home on own and did not want further medical assessment.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,PUB,Abilify,None,Bi polar,,"Sulfa, hydrocodone",['Pruritus'],2,MODERNA,IM 1046732,OH,53.0,F,"Extreme muscle pain, tightness in chest, headache with sensitivity to light, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/16/2021,0.0,WRK,,,,,,"['Chest discomfort', 'Chills', 'Headache', 'Myalgia', 'Photophobia']",2,MODERNA,IM 1046733,GA,53.0,M,"Error: Wrong Route (SC, IM, etc.)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,SEN,,,,,,['Unevaluable event'],1,PFIZER\BIONTECH,IM 1046734,,28.0,F,fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/20/2021,01/21/2021,1.0,PVT,,,,,,['Fatigue'],UNK,MODERNA, 1046735,ND,47.0,F,"2/19/2021 at 0300 - fever of 102.9 F, headache, body aches and chills 2/19/2021 at 0900 - fever of 102.8 F, headache, body aches and chills - took OTC Excedrin 2/19/2021 at 1100 - fever of 100.6 F, headache, body aches and chills 2/19/2021 at 1230 to 1430 - took a nap 2/19/2021 at 1430 - woke up with fever of 104.1 F - ice packs x 2 to neck, armpits and groin, took a cool bath - took Extra Strength Tylenol 2/19/2021 at 1520 - fever of 101.1 F 2/19/2021 at 1730 - temperature of 98.0 F 2/19/2021 at 2030 - temperature of 99.4 F 2/19/2021 at 2130 - temperature of 100.5 - went to bed",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PUB,"metoprolol succinate ER 25 mg, pantoprazole 20 mg, vitamin D 5000 IU, vitamin B complex escitalopram 20 mg",,,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",2,MODERNA,IM 1046736,MI,40.0,F,"Within 5 minutes of injection, i became light headed, flushed in the face and hand, and hot/sweaty. These were mild/moderate symptoms and came and went for about 1 hour, decreasing in severity from the time of injection. They were the worst within the first 20 minutes post injection. I consulted with Dr. prior to my vaccination due to my mast cell disorder; he said to take 2 Zyrtec an hour prior to injection - which i did. I still had the above reaction. Also had pain at injection site for approx 48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,WRK,"Zyrtec, benedryl",None,"Bipolar disorder, GERD, Mast cell activation disorder",,None,"['Dizziness', 'Feeling hot', 'Flushing', 'Hyperhidrosis', 'Injection site pain']",UNK,MODERNA,IM 1046737,CT,55.0,F,"Within 18 hours of injection: Severe chills(couldn't get warm no matter what I did) fatigue headache muscle/joint pain-hurt to walk Severe arm pain at injection site lump under arm(still here 5 days after injection) Two days after injection: Arm swollen from upper down to wrist Swollen, itchy, painful....still red/rash/itchy five days later",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,UNK,One a Day vitamin Tumeric,,,,allergic to scallops,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site mass', 'Injection site pain', 'Joint swelling', 'Myalgia', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Rash erythematous', 'Rash pruritic']",2,MODERNA,SYR 1046738,AZ,33.0,F,"Nine days after receiving the vaccine I developed rashes on my elbows, knees, and ankles and in my joints. Wrse though, was the inability to bend my fingers after they swelled up and had incredibly itchy welts all over. Benadryl did not help0, the itching, soreness, and inability to bend my fingers persisted for approximately 4 days. I had a headache that was severe as well. I made two trips to the emergency room and then followed up with my primary physician.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,02/04/2021,9.0,PVT,none,no,no,,Penicillin,"['Blood test normal', 'Headache', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Rash', 'Urticaria']",1,MODERNA,SYR 1046739,VA,68.0,F,"Pfizer vaccine was given as a first dose, Moderna as the second. Vaccines were given 18 days apart.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,02/15/2021,17.0,PUB,,,,,,['Interchange of vaccine products'],1,PFIZER\BIONTECH,IM 1046740,,22.0,F,pain and chills,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/22/2021,01/23/2021,1.0,PVT,,,,,,"['Chills', 'Pain']",UNK,MODERNA, 1046742,IL,81.0,M,"Rash, swelling and warm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/10/2021,2.0,PUB,lisinopril/hctz 20-25mg daily,none,,,none known,"['Rash', 'Skin warm', 'Swelling']",2,MODERNA,IM 1046743,KS,37.0,F,"Noticed the ""covid arm"" bulls-eye rash that morning, on day 12 after my first dose. It lasted about about 48 hours. There was no pain/itching/burning at the reaction site. If I hadn't seen in in the mirror, I would not have known it was there.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,02/06/2021,12.0,PUB,Sprintec birth control.,None.,None.,,None.,"['Erythema', 'Rash']",1,MODERNA,SYR 1046744,MI,58.0,F,"Fever, runny nose, fatigue,cough",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/30/2021,01/31/2021,1.0,SEN,,,,,,"['Cough', 'Fatigue', 'Pyrexia', 'Rhinorrhoea']",UNK,MODERNA,IM 1046745,CA,24.0,F,Rashes and bruises,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,OTH,Tylenol,None,None,,None,"['Contusion', 'Rash']",2,PFIZER\BIONTECH,SYR 1046746,TX,38.0,F,"Five days after receiving first dose, red, itchy bumps appeared on my right wrist. Days following, the bumps started spreading to my left hand, abdomen and continued. I received my second dose on 01/31/2021, and have continued to have the itchy rash spreading to different body parts (thighs, chest, and face). Benadryl controls the itching, but bumps continue to appear and itch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/06/2021,4.0,PHM,None,None,None,,Flagyl,"['Rash', 'Rash erythematous', 'Rash pruritic']",2,MODERNA,IM 1046747,CA,37.0,F,"I had ""COVID"" arm on my left arm where by the injection that measured 2 1/2 inches by 1 1/2 inches. It apperead 7 days after injection and lasted almost 3 full days.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/08/2021,02/15/2021,7.0,PUB,No,No,No,,I'm allergic to Thimerosal and Neomycin,['Injection site reaction'],UNK,MODERNA,IM 1046748,MN,48.0,F,"Chills 2/16/22 10 pm to 3 am, fever 2/17/21 8:30 am, fever gone 9:15 am, fever 11 am, fever gone 11:30 am. Better after that.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,WRK,"Daily vitamin, calcium 250 mg, loratidine 5 mg",None,None,,None,"['Chills', 'Pyrexia']",1,MODERNA,SYR 1046752,KS,70.0,M,"Pt was hospitalized Jan 18, 2021 after he had fallen outside overnight and lay there approximately 12 hours until he was found. Hypothermic & rhabdomyolis diagnosis. Gradually improved w/ strength & mental status - was in swing bed @ hospital. He got his first Covid 19 shot on 2-8-21. Was fine @ 0300 on 2-9-21 and @ 0430 he was found unresponsive. Dx: probable arrythmia & pronounced dead @ 0454. Noted on pain scale @ 2/8/21 @ 21:11, clients pain was a 7/10 They offered pain med & he refused They repositioned & distracted him @ 2047 on 2/8/21 Pain had decreased to 3/10 and nothing given. Then @ 0300 check he was sleeping and @ 0430 unresponsive.",Yes,02/09/2021,Not Reported,Yes,21.0,Not Reported,N,02/08/2021,02/09/2021,1.0,PVT,"apixaban, aspirin, Ativan, baclofen, carbidopa - levodopa","Rhabdomyolysis, dementia d/t Parkinsons disease w/ behavioral disorder","Atypical Parkinsonism, HTN, diplopia, Neurological gait disorder, osteoarthritis",,No known allergies,"['Arrhythmia', 'Chest pain', 'Death', 'Fall', 'Hypothermia', 'Pain', 'Refusal of treatment by patient', 'Rhabdomyolysis', 'Unresponsive to stimuli']",1,MODERNA,IM 1046753,PA,73.0,F,"red, warm, and painful to the touch on site where the vaccine was given. Treatment given Amoxil 500mg 3 times a day, for 7d.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/23/2021,1.0,PHM,TYLENOL 500MG BIOTIN 1MG CALCIUM VITAMIN D3 KLONOPIN PROLIA DEXILANT ROBITUSSIN,,"Leukopenia, unspecified type Panic attacks Medication monitoring encounter Binge eating disorder Nasal pain Hypercholesterolemia Abnormal PFTs (pulmonary function tests) Elevated blood pressure reading",,ASPIRIN AZITHROMYCIN CEPHALEXIN SULFA TETRACYCLINE BEE STINGS,"['Injection site erythema', 'Injection site pain', 'Injection site warmth']",UNK,MODERNA, 1046756,KY,80.0,M,"1st dose vaccine 1/30/21; 2nd dose vaccine 2/20/21; new onset weakness 2/21/21; fell at home and seen in ED and admitted to hospital 2/22/21 Dx on admission: 1. Hypoxia 2. Elevated troponin 3. Elevated brain natriuretic peptide (BNP) level 4. Generalized weakness 5. Closed head injury, initial encounter",Not Reported,,Not Reported,Yes,,Not Reported,N,02/20/2021,02/21/2021,1.0,PVT,,,Multiple; see chart,,NKA,"['Asthenia', 'Brain natriuretic peptide increased', 'Craniocerebral injury', 'Fall', 'Hypoxia', 'Troponin increased']",2,PFIZER\BIONTECH,IM 1046757,CA,72.0,F,Moderna COVID-19 Vaccine EUA. Nausea and vomiting.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/22/2021,3.0,UNK,"amlodipine, losartan, atorvastatin, sertraline, aspirin 81mg., fluticasone, symbicort, albuterol, caltrate with 600mg Vitamin D.",None.,"Hypertension, asthma, elevated cholesterol, anxiety.",,"aspirin, amoxicillin and sulfa drugs.","['Nausea', 'Vomiting']",2,MODERNA,IM 1046758,AL,54.0,F,"Woke up at 5:30am on Feb. 22, 2021 with my arm itching only at the site of the shot on my left arm. Very red and had heat in it. Experienced head ache with sharp pains in various locations inside my head the day before. As of 1:10pm on the same day, the redness is still there and is warm to touch. No swelling appears to be at the site. I did not have any side effects of the shot at any other time other than tasting a sweet taste in the back of my throat 2 minutes after being given the shot. It went away by the time I was released from vaccine location.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/22/2021,13.0,OTH,"No prescriptions or over the counter drugs taken and no supplements taken other than vitamin C,D, and zinc on the days I remember to take them.",None,None,,None,"['Dysgeusia', 'Headache', 'Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,SYR 1046759,MI,68.0,F,"Itching at site starting on 2/20/2021. Red rash below injection site seen on 2/22/2013 , uneven measuring about 2? by 2?. Pink dot where needle went in.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/20/2021,8.0,PHM,"Levothyroxine 25 mcg in the morning HCTZ 12.5 mg in the morning Losartan 50 mg in the evening Xanax 0.25 mg as needed Vitamin D 5,000 IU daily Probiotic Blend , Bacillus Coagulans (4 billionCFU) twice daily Triple Immune Power (Prebiotic",None,Arthritis Scoliosis Kyphosis HTN,,Nickel Ceftin Vibratab Vantin Biaxin Macrodantin,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 1046761,MI,47.0,F,"Chills, body ache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/31/2021,1.0,SEN,,,,,,"['Chills', 'Pain']",UNK,MODERNA,IM 1046762,,,U,"Body rash. Mostly chest, shoulders and some face",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Rash'],2,PFIZER\BIONTECH,SYR 1046763,OH,84.0,F,1/23 - Mild injection site discomfort. Appetite loss compared to previous day. Beginning loss of mental acuity compared to previous day. 1/24 - Continued loss of appetite. Near complete loss of ability to move. Continued decline of mental acuity. Very little speaking. 1/25 - Stopped speaking completely. Loss of bowel control in the evening and continued until death. Complete loss of appetite. 1/26 - Near complete loss of ability to swallow. Moved to hospice 4:00pm. 1/27 - Died 4:00am,Yes,01/27/2021,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/23/2021,0.0,PVT,"4.125mg orenitram (3/day), 40mg sildenafil (3/day), 4mg dexamethasone (1/day), 20mg furosemide (1/day), 3mg budesonide (1/day), 600mg calcium (2/day), 20mg omeprizol (2/day), 168mg cranberry concentrate (2/day), probiotic (1/day), 100mg met",bilateral pneumonia,"lung cancer (metastatic non-small cell carcinoma), emphysema, pulmonary hypertension",,"scallops, contrast dye (ivpDye, iodine containing), epinephrine, reglan, compazine, adhesive tape","['Anal incontinence', 'Aphasia', 'Communication disorder', 'Death', 'Decreased appetite', 'Dysphagia', 'Injection site pain', 'Mental impairment', 'Mental status changes', 'Mobility decreased']",1,PFIZER\BIONTECH,IM 1046764,,65.0,F,My arm became very red (like a sunburn) from the injection site down to the crook of my arm and itched intensely for 3 days or so.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,MIL,,,Rheumatoid Arthritis,,,"['Erythema', 'Pruritus']",2,MODERNA,SYR 1046765,WA,69.0,F,"I discovered a raised red circle around the injection site, about 2 inches in diameter, two weeks after the injection. It is still very visible two days after the discovery. There is some soreness as well as itchiness related to the redness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/20/2021,14.0,OTH,Vitamin B Complex,None,None,"Slight illness after Shingles 2nd Shot Dec 28, 2020",Penicillin,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 1046766,MD,69.0,F,"about 10 days after receiving the vaccine started with new onset A. Fib and shortness of breath especially on exertion. I am in work up for same Holter monitor, ECHO, ETT and f/u with cardiology",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/15/2021,10.0,PVT,"Lisinopril/HCTZ amlodipine famotidine Potassium, magnesium, vit D, glucosamine/chondroitin, ASA, zyrtec,",none,"HTN, OSA, obesity, heart Murmur, GERD",,"NKDA , NKA","['Atrial fibrillation', 'Dyspnoea', 'Dyspnoea exertional', 'Echocardiogram', 'Electrocardiogram ambulatory', 'Exercise test']",1,MODERNA,IM 1046768,MA,30.0,F,"I received my vaccine on 2/10/21. I had expected side effects of fevers, chills, body aches, headache on 2/11 - 2/13. I continued with a persistent headache throughout the week. A presure in my head, worse with standing up, and it made me dizzy when I stood up. On the night of 2/18/21 I developed left sided ear pain. On 2/19/21 I developed a left sided otitis media. On 2/21/21 I developed sudden onset left sided facial droop. I had a negative head CT, and was diagnosed with bells palsy related to the swelling in my ear from the otitis media. I continue to have significant ear pain, and left sided facial paralysis today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/21/2021,11.0,WRK,None,None,None,,None,"['Antibody test negative', 'Chills', 'Computerised tomogram head normal', 'Dizziness', 'Dizziness postural', 'Ear pain', 'Ear swelling', 'Facial paralysis', 'Full blood count normal', 'Head discomfort', 'Headache', 'Metabolic function test', 'Otitis media', 'Pain', 'Pyrexia']",2,MODERNA,IM 1046769,NY,73.0,F,"Patient experienced headache and nausea that started on day 1 post vaccination of 2nd dose Moderna. Patient was advised to take over-the counter Tylenol 2 tab every 6 hours as needed for symptoms. Patient took this for 3 days and still had no relief. Patient advised to increase fluid intake, eat small meals with bland foods (dry toast, crackers), try caffeinated beverage like coca-cola on ice and to alternate tylenol with ibuprofen (2 tab every 6 hours). Patient had no relief and presented to ER, had bloodwork and urine done with no findings. Patient still has nausea and headache on day #6 post vaccination. Has MD appointment this week (2/25/21).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,PVT,Simvastatin Citalopram,Unknown,Unknown,,None reported,"['Blood test', 'Headache', 'Nausea', 'Urine analysis']",2,MODERNA,IM 1046770,IN,37.0,F,Extreme fatigue days 4 to 9 days post vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/09/2021,4.0,PHM,"Multi vitamin, Vitamin C, Vitamin D, Zoloft 75 mg, Turmeric, B Complex",Achilles tears was taking Naproxen 1000 mg for almost 8 weeks,Anxiety,,None,"['Epstein-Barr virus antibody positive', 'Fatigue']",1,MODERNA,IM 1046771,AZ,63.0,F,Started experiencing heart palpitations within minutes of receiving vaccine. Heart rate is between 170-180 bpm. Patient states that she has had ?palpitations? in past but has never been diagnosed with cardiac condition. Is currently on SVT rhythm on EKG. Attempted to have patient vagal down with no change in heart rate. Patient was transferred to paramedics for transport to Medical Center.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/17/2021,0.0,PUB,"Metformin, lovastatin, metoprolol, losartan",,"Diabetic, high cholesterol, high blood pressure.",,Penicillin,"['Condition aggravated', 'Electrocardiogram abnormal', 'Heart rate increased', 'Palpitations', 'Supraventricular tachycardia']",2,MODERNA,IM 1046772,NV,58.0,M,"1. Arm muscle very sore to date. 2. 10 days after the shot, tennis ball rash appeared on shoulder at the injection site. Very inchy, skin felt like leather, loss of feeling on rash site, lasted 5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,PVT,none,none,headaches,,none,"['Dry skin', 'Injection site reaction', 'Myalgia', 'Rash pruritic', 'Sensory loss']",1,MODERNA,IM 1046773,WI,31.0,F,"1/26/2021 vaccination 1/27 I got up to breast feed daughter, I could tell I was achy, chills, sweating. Progressed as day went on. Lasted for approximately 3 days. Sore arm, raised welt on arm at injection site. Sore throat, my lymph nodes were swollen. * 1/8 COVID +",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/27/2021,1.0,PVT,"vitamins, Valtrex, singular",COVID +; 1/8/2021,,"COVID 19 1st dose; diarrhea, stomach cramps x2 days",sulfa,"['Chills', 'Hyperhidrosis', 'Injection site pain', 'Injection site reaction', 'Injection site swelling', 'Injection site urticaria', 'Lymphadenopathy', 'Oropharyngeal pain', 'Pain']",2,PFIZER\BIONTECH,SYR 1046774,NY,56.0,M,"Approximately 12 hours after vaccination, woke up with numbness and tingling on complete right side of my body. Reaction has not gone away since the vaccination, 3 weeks ago. The reaction has decreased butt still exist up and down my right arm and hand, along on the right side of stomach.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/22/2021,20.0,MIL,"Insulin, Enalipril, Vitamins, multiple other meds",None,"Diabetes, High blood pressure, COPD, CHF, Asthma",,None,['Hypoaesthesia'],UNK,PFIZER\BIONTECH, 1046775,IN,73.0,M,"He noticed a sore arm on the following day. He then noticed irritability for several weeks, but does not have it now. He had a lack of concentration for more than a week that lasted 2-3 weeks. Diarrhea 9 days after the vaccine that lasted for about a week. General tiredness for about 2 weeks. 2 weeks and 2 days after vaccine had high BP, and it's better today at his APT. Had occasional heart racing while doing some light snow shoveling 3 weeks after the vaccine, and it went away after that. Chills off and on for about 10 days after to about 22 days after. Also had loss of appetite about 2 weeks after the vaccine that lasted several days. He also had a couple of days really poor sleep, irregular and several days that he had night mares 2-3 weeks after the vaccine. A couple of weeks after the vaccine did not just feel very good, like he had the flu. He also has had itching on the top of his feet and ankles that did not start until after the vaccine, and still has depending on what socks he's wearing. He also had a swollen right ear that was real sore and had to go to the doctor to get the swelling down using some ear drops.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/24/2021,01/25/2021,1.0,OTH,"Lithium, simple truth prostate support, Vitamin D.",None.,None.,"2nd vaccine was on 2/18/21, lot #EN6201, soreness on the left arm but not as noticeable as the first vaccine. His left ear was ",None.,"['Chills', 'Decreased appetite', 'Diarrhoea', 'Disturbance in attention', 'Ear pain', 'Ear swelling', 'Fatigue', 'Hypertension', 'Influenza like illness', 'Irregular sleep phase', 'Irritability', 'Malaise', 'Nightmare', 'Pain in extremity', 'Palpitations', 'Poor quality sleep', 'Pruritus']",1,PFIZER\BIONTECH,IM 1046776,CA,73.0,F,Swelling and redness in upper arm. Did not show up until 2 Weeks after shot. Itchy and sensitive.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/21/2021,13.0,OTH,None,None,None,,Sesame seed oil or paste.,"['Erythema', 'Peripheral swelling', 'Pruritus', 'Sensitive skin']",1,MODERNA,SYR 1046777,AL,65.0,M,"Patient wife called store stating that patient has been experience shortness of breath, fever since he received vaccination. Approximately, 4 days now",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,PHM,,,COPD,,,"['Dyspnoea', 'Pyrexia']",1,MODERNA,IM 1046779,PA,35.0,F,3 days after first vaccine shot my thumb became a little numb and tingly and it eventually spread to the 2nd and 3rd finger however no other side affects. When I went fir 2nd shot I asked pharmacist administering shot abs he said last time they may have hit a nerve I had no other side affects so I got second dose. Approximately 3/4 days after second dose on February right fingers became more numb and on 2/15 numbness started in left hand as well. Then on 2/19 started experiencing numbness weakness and tingling in both feet which progressively got worse so I went to the ER on 2/21. Blood work all came back normal and was sent home still having symptoms and told to see neurologist however still awaiting appt,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/22/2021,3.0,SEN,multi vitamin,none,,,none,"['Blood test normal', 'Hypoaesthesia', 'Muscular weakness', 'Paraesthesia']",2,PFIZER\BIONTECH, 1046780,TX,43.0,F,Diarrhea fever body aches no energy overall feeling ran down,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/21/2021,02/22/2021,1.0,OTH,Valtrex,No,No,,Sulfa,"['Asthenia', 'Diarrhoea', 'Pain', 'Pyrexia']",2,MODERNA,IM 1046781,MI,24.0,F,"Body aches, chills, Headache, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/30/2021,01/31/2021,1.0,SEN,,,,,,"['Chills', 'Headache', 'Nausea', 'Pain']",UNK,MODERNA,IM 1046782,HI,60.0,F,"During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations/dizziness with BP of 157/99, requested transfer to ED for further evaluation. Began experiencing scratchy sensation to throat, difficulty swallowing with hoarseness of voice 5 minutes after vaccination. Received epinephrine 0.5mg IM once, protonix 40mg IV once, and solu-medrol 125mg IVPB once in ED. Patient was observed in ER for 3 hours and reported having EpiPen and Benadryl at home, was discharged with Prednisone 20mg, 2 tablets daily for 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PVT,,,,,"Amlodipine, Bactrim, Bystolic, Ciprofloxacin, Clarithromycin, Duloxetine, Enalapril, Ethanol, Fluconazole, Green tea, losartan, Metronidazole, morphine, phenazopyridine, sertraline, shellfish, shrimp, zoloft","['Dizziness', 'Dysphagia', 'Dysphonia', 'Palpitations', 'Throat irritation']",1,PFIZER\BIONTECH,IM 1046783,WA,55.0,F,dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PVT,,,Graves disease,,,['Dizziness'],2,PFIZER\BIONTECH,IM 1046784,MD,92.0,M,Patient was later hospitalized with COVID-19,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/05/2021,02/12/2021,7.0,PVT,,,,,NKA,['COVID-19'],1,MODERNA,IM 1046785,IN,60.0,M,muscle pain on my arm insistently,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/09/2021,0.0,UNK,not at all,no,no,,Penicillin when I was a child,['Myalgia'],UNK,PFIZER\BIONTECH, 1046786,MI,66.0,F,"Exhaustion, headache, loss of appetite, nightmares, chills and fevers, profuse sweating, diarrhea, body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/19/2021,18.0,OTH,"Wellbutrin, Prozac, lipitor,","None. First shot exhaustion, loss of appetite, soreness at shot location lasting 48 hrs.",None,,None,"['Chills', 'Decreased appetite', 'Diarrhoea', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Nightmare', 'Pain', 'Pyrexia']",2,MODERNA,SYR 1046787,AK,58.0,F,"ADVERSE reaction: Large nectarine sized lump, red rash, hot to the touch which may be getting slightly worse. Haven't contacted medical personnel yet. 10 days post vaccine today. POSITIVE reaction: The cough I had suffered with all of the previous year has mysteriously gone away. The same day I received the vaccine I stopped coughing, taking night time cough medicine and raising mattress on bed. I had taken several rounds of antibiotics, 1 in late 2019 and a couple more in early 2020, as well as 2 or 3 rounds of Advair. Besides prescription non narcotic cough meds, zyrtec and the rounds of Advair and antibiotics...I tried nose washes, humidifiers, vics inhalers, menthalatum, nyquil, etc. etc.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/13/2021,0.0,PVT,"Losartan Potassium-HCTZ 100-25mg, Lamictal 150mg, Methylphenidate HCI ER 20mg, Vitamin D3 5,000iu, Bayer Aspirin 81mg, Zyrtec Allergy 10mg.",None,"Have had a sometimes wet and sometimes dry cough since December, 2019. Got very sick when traveling October 10, 2019. Lasted just a few days. Cough started shortly thereafter and have been coughing all year. Had several rounds of antibiotics in early 2020 and was prescribed a non narcotic cough syrup. Also had to raise bed mattress to sleep easier. Unable to use BiPap machine during ongoing cough. High Blood pressure, bi-polar, ADD, TBI.",,None,"['Mass', 'Rash erythematous', 'Skin warm']",1,MODERNA,SYR 1046788,IL,26.0,F,"Moderna COVID-19 Vaccine EUA Fever, chills, body aches, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PVT,100mg Lamotrigine 40mg Latuda,,,,soy,"['Chills', 'Headache', 'Pain', 'Pyrexia']",2,MODERNA, 1046789,CA,67.0,F,"On the 10 th day after vaccine arm began to itch and burning with a round red patch . About 2 inch in diameter. Was better in two days . Then The burning has return on day 14 and again on day 16th after first shot. Don?t have a rash, just burning sensation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/06/2021,02/15/2021,9.0,PVT,Vitamin D,None,None,,None,"['Burning sensation', 'Erythema', 'Pruritus']",1,MODERNA,SYR 1046790,,76.0,M,"First 24 hours had cold feet, cold hands sleepy hands and chills ..very fatigued, Within the next 6-hours developed fever---slight fever of 101 that was taken care of with Tylenol. Muscle- aches and slight redness at area of injection. After 48 Hours felt a lot better. No fever--nothing!",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,MIL,None,None,COPD Back Spinal problems,,None,"['Chills', 'Fatigue', 'Injection site erythema', 'Myalgia', 'Peripheral coldness', 'Pyrexia']",UNK,MODERNA, 1046791,WA,66.0,F,"was very sick after shot but told that was normal with people who have had covid. Took abut 8 days to feel ""normal"" then today woke up to a rash on the arm of the injection site that was quite large, red and sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/22/2021,11.0,PHM,claritin,no illness other than long covid,long covid,do not remember details but got severely ill after a flu shot,"anti-biotics, codeine","['Malaise', 'Pain in extremity', 'Rash']",1,MODERNA,IM 1046792,PA,80.0,F,Wednesday i had vomiting This time i had diarrhea and like i had cold symptoms we gone by Friday.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PVT,NO,NO,NO,,NO,"['Diarrhoea', 'Nasopharyngitis', 'Vomiting']",2,MODERNA,IM 1046793,NC,27.0,F,Started period within one week of having each vaccine and then approx. every 2 weeks since,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/08/2021,4.0,PVT,Spironolactone,,"PCOS, Pilonidal cyst",,none,['Polymenorrhoea'],2,PFIZER\BIONTECH,IM 1046794,CA,61.0,M,"On 2nd dose, 2/1/21: Severe body and deep joint aches, fever of 101, extreme chills, inability to sleep, headache, profuse sweating lasting until 2/3/21. Still experiencing lingering arm pain at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,PVT,"Meds: Hydroclorothiazide, Lisinopril, Atorvastatin, Aspirin. Supplements: B2; Magnesium, Vitamin C",,"Blood Pressure, Diabetes, Vascular small vessel disease",,Liquid Penicillin,"['Arthralgia', 'Chills', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Insomnia', 'Pain', 'Pyrexia']",UNK,MODERNA, 1046795,TX,64.0,F,Per ED note: Brought in ED by EMS at 1945 for acute shortness of breath and hypotension. Patient was placed on supplemental oxygen and covid test completed. Patient was placed on BiPAP to maintain oxygen greater than 90%. Found to be in metabolic acidosis. Patient became unresponsive and pulse could not be palpated. Chest compressions were initiated. ACLS medications given and pulses regained. Patient lost pulse 30 mins later and never regained pulse. Per ED noted; likely developed a PE. Passed away at 2127,Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/21/2021,9.0,PVT,"Flagyl 500 mg TID, Tramadol 50 mg q4h PRN, Gabapentin 400 mg q 8h, lisinopril 10 mg daily, duloxetine 30 mg daily","Recurrent IVb uterine carcinosarcoma, open ventral abdominal wall","uterine cancer, PE, CHF",,Sulfa medications,"['Bilevel positive airway pressure', 'Blood gases', 'Blood lactic acid', 'Chest X-ray', 'Death', 'Dyspnoea', 'Full blood count', 'Hypotension', 'Metabolic acidosis', 'Metabolic function test', 'Oxygen therapy', 'Pulse absent', 'Resuscitation', 'SARS-CoV-2 test', 'Unresponsive to stimuli']",1,MODERNA,IM 1046796,CA,68.0,F,A large red circle 3 inches round appeared on morning 10 after vaccine. after 3 days seemed to diminish then on day 4 was back. No treatment,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/16/2021,15.0,PVT,"simvastatin, levothyroxine. lisinopril, vitamin D, B-12",none,none,,doxycycline and amoxicillin,['Erythema'],1,MODERNA,SYR 1046797,WI,79.0,M,severe rash both arms swelling of lips rash both hips-armpits,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/14/2021,9.0,PUB,atenolol simvastatin,none,none,,lisinopril,"['Lip swelling', 'Rash']",1,MODERNA,IM 1046798,TX,68.0,F,3 inch red mark on right arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/30/2021,9.0,PUB,"metformin, lisinopril,simvastatin",,diabetes,,,['Rash'],1,MODERNA,IM 1046799,OH,65.0,F,At 11:50 am (1 hour and 50 minutes) after receiving the shot my eyes started swelling. I took a Benadryl immediately which relieved some of the swelling. At approximately 9:30 p.m. I noticed a rash on my left cheek which was gone by the following morning.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PVT,"Atorvastatin Calcium 20mg, Levothyroxine .75mcg, Vitamin B6 100mg, B12 500mg, C 500mg, Calcium 600mg, CoQ10 200mg, D3 5000 IU, Triple Magnesium Complex 400mg, Member's Mark, Women's 50+ Multivitamin, Boswellia 250mg, Zinc 50mg, Tumeric Cu",Sinusitis,None,,"Latex, Gold Sodium Thiosulfate, Neomycin, Bacitracin, Crab","['Eye swelling', 'Rash']",1,PFIZER\BIONTECH,SYR 1046800,,56.0,F,"Dry mouth, queasy, headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,,,,,,"['Dry mouth', 'Headache', 'Nausea']",2,MODERNA,IM 1046801,DC,44.0,F,Rash across middle of back. Painful and itchy. Scattering of raised red bumps surrounded by pink. Lasted two days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/14/2021,1.0,PHM,"Zinc, Vitamin D, NAC",None,None,,"penicillin, clindamycin, codeine","['Rash', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",1,MODERNA,IM 1046802,MI,47.0,F,"Nausea,bodyache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/31/2021,1.0,SEN,,,,,,"['Nausea', 'Pain']",UNK,MODERNA,IM 1046803,TN,30.0,F,"Within less than 24 hours after receiving the vaccine I developed hives on my face. I have had breakouts of hives on my face every day since then. I have woken up with them in the morning and then they will come and go throughout the day up to 3 times. Also experienced rashes on my face. No pain, wheezing, or other adverse effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,PVT,Lessina birth control pill,,,,Penicillin,"['Rash', 'Urticaria']",UNK,PFIZER\BIONTECH,SYR 1046804,TX,70.0,F,"About a week after the first vaccination and one day after the second vaccination I developed a red rash on my arm adjacent to the injection site. With the second shot the area is very warm, swollen, and tender to touch. The first time there was very little pain or itching. The second is more uncomfortable.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/21/2021,1.0,PVT,"Metformin ER two 500 mg tablets twice a day Synthroid 75 - once a day Aspirin 81 mg Escitalopram Oxalate 20 mg tab 1 daily Rosuvastatin Calcium 10 mg tab 1 daily Alegra 12-hour 1 in AM Vitamin C, vitamin D, Calcium",Mouth pain,Waldenstr�m's Macroglobulinemia (in remission since 2016) Early Parkinson's Disease. Sinus headaches due to seasonal allergies to trees,,"Allergies to penicillin, Keflex, sulfa, morphine","['Injection site erythema', 'Injection site pain', 'Injection site rash', 'Injection site swelling', 'Injection site warmth']",2,MODERNA,IM 1046805,CA,67.0,F,"covid arm, appearing about 9 days after 1st dose - red blotch about 2X3 inches in size - soreness after blotch formed",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/21/2021,9.0,PHM,"vitamins, many supplements,bio-identical hormone creams",none,none,,none,"['Pain in extremity', 'Rash macular']",1,MODERNA,IM 1046806,CA,48.0,F,"2/19/21-swollen arm 2/20/21-fever, chills, shortness of breathe Patient stated she went to urgent care",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,none,none,none,,none,"['Chills', 'Dyspnoea', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 1046807,CA,66.0,F,"Just this morning, day 9 I developed a large red patch at the injection site. It is very itchy. Funny, I did not have this following the injection. Does not appear serious just wondering if anyone else has had this response",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/13/2021,02/22/2021,9.0,UNK,none,none,none,,cats,"['Injection site reaction', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,SYR 1046808,WA,48.0,F,"The morning after vaccination, patient woke up with stinging, burning, itching rash with pustules on her back at waist area. Unconfirmed shingles. Pt denies fever, chills, headache, any other symptoms. At time of this report, pt had not yet been seen. She will see her PCP tomorow.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/21/2021,1.0,OTH,,,autoimmune condition,antibiotic,,"['Burning sensation', 'Pain', 'Pustule', 'Rash', 'Rash pruritic', 'Rash pustular']",1,MODERNA,IM 1046809,AZ,63.0,F,Minutes after receiving vaccine pt started experiencing ?heart palpitations ?. Puts heart rate is between 170-180bpm and is showing SVT rhythm on EKG. Pt did vagal maneuvers with no change in heart rate. IV established and care transferred to paramedics for transport to emergency department.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/17/2021,0.0,PUB,"Losartan, metformin, lovastatin, metoprolol",None,"Diabetic, high blood pressure, high cholesterol",,Penicillin,"['Electrocardiogram abnormal', 'Palpitations', 'Supraventricular tachycardia']",2,MODERNA,IM 1046810,CA,37.0,F,"After my second dose of the vaccine I had typical flu-like symptoms (fever 101.5, chills/shivering, body pain, headache, nausea) yet also developed acute and severe shortness of breath. My flu-like symptoms resolved within 48 hours yet my breathing difficulties continued and worsened. I was treated in the Emergency Department on 1/12, 1/19 and 1/20 (work up negative for covid, pulmonary embolism, infection, cardiac abnormalities). It feels as though I am having intractable diaphragm spasms that are forcing my exhales out at the end of my breath cycle. I have lost 10lbs and have been essentially incapacitated for 6 weeks. I have been evaluated by head and neck (no vocal cord dysfunction), speech pathology (no swallowing difficulties), pulmonology (no lung specific issues) and am awaiting a neurology consult.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,SEN,none,none,"history of migraines, colitis",,erythromycin,"['Chest X-ray normal', 'Chills', 'Computerised tomogram thorax normal', 'Condition aggravated', 'Diaphragmatic spasm', 'Dyspnoea', 'Echocardiogram', 'Electrocardiogram normal', 'Fibrin D dimer increased', 'Forced expiratory flow', 'Headache', 'Influenza like illness', 'Nausea', 'Oxygen saturation decreased', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Ultrasound abdomen', 'Weight decreased', 'X-ray']",2,PFIZER\BIONTECH,IM 1046811,MN,84.0,F,Patient has had ongoing diarrhea since 2/16/21. 3-4 episodes per day. Patient took otc immodium which has not made a difference. Patient was encouraged to see primary care provider for prescription alternatives and to make sure to stay hydrated.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/16/2021,1.0,PHM,None,None,cancer,,Latex/eggs,['Diarrhoea'],1,MODERNA,IM 1046812,AK,66.0,M,"Had chest pain (""lung pain"") the day after vaccination, then 2 days after the shot, he experienced some dizziness and nausea. Dizziness and nausea lasted for 3 days and 3 nights. Chest pain persisted and seems to be getting worse. Severity 3/10 - 7/10. + pain with movement, none at rest. No dyspnea, shortness of breath or fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/09/2021,1.0,PVT,"Atorvastatin, HCTZ, Lisinopril, Metformin, Omeprazole",,"Hypertension, DM type 2",,,"['Chest pain', 'Dizziness', 'Nausea', 'Pain', 'Pulmonary pain']",2,PFIZER\BIONTECH,IM 1046813,,86.0,F,Resident received the 2nd does of the vaccine 2 times by mistake. She got the first does on 1/72021 then the 2nd does on 1/28/2021 and got the 2nd dose again on 2/18/2021. In the area where the resident resides there are 2 people with the same name and we believe that caused the confusion. The pharmacy tech called the CDC and Pfizer and they had no recommendations other than to monitor for any side effects.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/18/2021,0.0,UNK,,,,,,"['Circumstance or information capable of leading to medication error', 'Extra dose administered']",UNK,PFIZER\BIONTECH,SYR 1046814,FL,69.0,F,Patient developed a rash on both arms at 11:55am about 15 minutes after her shot. Patients blood pressure was taken (158/82) and was given 50mg of Benadryl orally. Patient was checked on at 12:15am and she was feeling ok. Patient's blood pressure was taken again at 12:25pm (157/89). Patient was checked on again at 12:45pm and she was feeling fine. Patient felt that her symptoms were gone and wanted to leave at 12:56pm. Patient was counseled to continue Benadryl if symptoms persist and to call emergency services if she began to worsen.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PHM,,,,,,['Rash'],2,MODERNA, 1046815,NC,71.0,F,"There was some soreness at the injection site the next day, but that went away. About 6 days later the injection site became itchy and a rash developed. There is a little soreness at the site also. I have been using an over the counter hydrocortisone ointment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/19/2021,6.0,PHM,Over the counter vitamins,None,None,,Indocyn,"['Injection site pain', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 1046816,NY,67.0,F,"I experienced a metallic taste in my mouth a few minutes after receiving the vaccine. I mentioned it to the pharmacist and was asked to report it to the CDC. It lasted a few minutes, with no other symptoms occurring.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PHM,"Hydroxychloroquine,Losartan, baby aspirin, Yuvafem, Centrum Silver vitamin, Align probiotic, Imodium, cranberry tablet",UTI,Lupus and asthma,,Sulfa meds and walnuts,['Dysgeusia'],UNK,MODERNA, 1046818,MI,34.0,F,Swollen (L) lympth Node,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/05/2021,3.0,SEN,,,,,,['Lymphadenopathy'],UNK,MODERNA,IM 1046819,VA,72.0,F,"One week later redness/rash/ swollen pone, hot to the touch, itching on spot of injection. Upper left arm. Noticed Sunday morning, 2/22/2021 about 10 AM. Continued on Monday 2/11/2021. Benadryl cream used on spot and 1 Benadryl taken.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/21/2021,8.0,PHM,"Simvastatin, Century Women's Multiple Vitamins; Caltrate, Magnesium,, B12, Elderberry, probiotic, Bone builder supplement,81 milligram Aspirin, Premarin",None,High Cholesterol; osteopenia,,Mild allergic reaction to Keflex,"['Erythema', 'Injection site pruritus', 'Rash', 'Skin warm', 'Swelling']",1,MODERNA,SYR 1046820,TX,71.0,F,Small bumps on both hand and both ankles. Like little pimples. They don't itch.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/15/2021,1.0,PVT,"Celecoxib caps 200Mg, Clonidine HCL 0.1mg, Gluticasone Propionate 50mcg, L-Thyroxine tas 125mcg, Liothyronine SOD 25Mg, Lisinopril tabs 40MG, Hydrochlorothiazide tabs 25 Mg, Hydroxychloroquine Sul tabs 200MG, Cabinoxamine Maleate 4mg, Metho",,Titanium neck,,"Alergic to grasses, mold, smoke , different trees, cats",['Rash'],2,PFIZER\BIONTECH, 1046821,IA,89.0,F,One week later it started itching and the next day it was red and hard. i was hurting on my neck and felt bad and couldn't stay away. I think I had a fever because I was sweating but started feeling better by Sunday,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/17/2021,7.0,PVT,"Magnesium, D3, Aspirin 81, Fish Oil 1000mg, Tylenol, Tums, Lexapro 10mg, Flonase, Metoprproal 50mg, Omegaprozol, Prevastin 40 Spirolactone 20mg Zyrtec Albuterol, Benonazopril",no,Heart stints 15 years ago - heart failure,,Statins and sulfa,"['Erythema', 'Feeling abnormal', 'Hyperhidrosis', 'Induration', 'Neck pain', 'Pruritus', 'Somnolence']",1,MODERNA,IM 1046822,CO,39.0,F,"3 days after vaccine I woke up with nausea, upset stomach. Symptoms resolved within 6 hours. 1 week after vaccine, woke up at 3:00am with nausea and heat wave/chills, resolved within an hour",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/16/2021,3.0,PVT,occasionally take melatonin for sleep Mirena IUD,,,,amoxicillin,"['Abdominal discomfort', 'Chills', 'Hot flush', 'Nausea']",1,PFIZER\BIONTECH,SYR 1046823,OR,68.0,F,"pt stated that the day after her vax she had 100 degree fever and was not feeling well. The second day she did not have a temp. She was feeling bad about every other day. About a week later she is still feeling bad, coughing and has lost her taste. She contacted her infectious disease doctor. He stopped her taking the Sevixtro medicine. He ordered her to take a sputum sample to have tested which she has not collected yet. Pt talked to her supervisor at work and they asked to get a covid test so she went to an Urgent Care where she tested negative. Pt has appt w/ her infectious disease doctor on 3/9/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,PVT,"clofazimine 200mg x2 daily, Sivextro 200 mg x 1 daily, Arikayce 500mg per vial (dose 1/2 vial x 3 per week - nebulized) Sp17 Sleep Aide, Gaba 500mg, melatonin 5mg, Vitamin C 1000mg x3 daily, Multivitamin w/ folate, B6 100mg, Ashwagandha 38",no,Pulmonary Lung Disease Non Tuberculosis Mycobacteria,,no,"['Ageusia', 'Cough', 'Malaise', 'Pyrexia', 'SARS-CoV-2 test negative']",2,MODERNA,IM 1046824,NH,74.0,M,Soreness at injection site when pressure is applied. Do not notice unless pressure applied.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,UNK,"atorvastatin 20 mg, metoprolol 50 mg, lisinipril 2.5 mg. baby aspirin, Vitamin D 2000 IU",none,coronary artery disease,,none,['Injection site pain'],UNK,MODERNA, 1046825,IL,66.0,M,"This patient received his first Moderna COVID vaccine on 2/5/21. He was scheduled for a COVID Vaccine 1st dose appointment today in error and received the Moderna COVID vaccine today, 2/22/21. He did not experience any immediate adverse events with today's vaccination. His PCP will be calling him daily for the next 48 hours to monitor for adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PVT,Amlodipine 10 mg daily Atorvastatin 40 mg daily Telmisartan 40 mg daily,None,"Hypertension, Hyperlipidemia",,NKDA,['Inappropriate schedule of product administration'],2,MODERNA,IM 1046826,AZ,86.0,U,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,OTH,metamucil,,asthma svt,,codene sensitive,['Unevaluable event'],2,PFIZER\BIONTECH,IM 1046827,AL,77.0,F,"Swelling and redness covering upper arm for 3dYs. Cold compresses, Zyrtec. Singular, ipubrophen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/1921,02/19/1921,1.0,PHM,"Lisinopril, nexium, zetia,",None,Thyroid problems,,"Penicillin, sulfa","['Erythema', 'Peripheral swelling']",2,MODERNA,IM 1046828,,68.0,F,PT stated that she has severe itching all over her body including arms. Pt denies any airway issues. Pt did not display any hives but arms were red due to pt scratching. Pt stated this happened the first vaccine but did not tell healthcare workers at screening nor did she annotate it on form. Pt was not given epi but EMS assist was called and pt was escorted to Emergency Room.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,MIL,,,,PT STATES THIS HAPPENED THE FIRST DOSE,,"['Pruritus', 'Rash', 'Urticaria']",2,PFIZER\BIONTECH,IM 1046829,CA,32.0,F,"Injection site pain, body aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,PVT,,,,,,"['Fatigue', 'Injection site pain', 'Pain']",2,PFIZER\BIONTECH,IM 1046830,FL,69.0,F,"A few hours after getting the vaccine, my arm became sore. It got worse as the night went on. It was extremely achy. It was still happening as of Saturday, I also felt lightheaded. I felt like a was on a merry-go-round, it felt like it kept getting faster and faster. I felt dizzy all day Saturday. I had to rest all day. I lost my appetite. Anytime I got up to go to the bathroom, I had to hold something to walk. I also had a mild headache. I felt better on Sunday. My arm was still a little sore as of yesterday but it is better today.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,OTH,"Triamterene 37.5 MG daily, HTCZ 25 MG daily, Losartan 25 MG daily, Latanoprost .005% eye drops in both eyes, another eye drop name unknown, Aspirin 81 MG, Calcium supplement, One day vitamin, Align one a day.",,"Hypertension, Glaucoma,",,"Milk products, ""mycins"" drugs, contrast dye, Oxycodone (Hallucinations)","['Decreased appetite', 'Dizziness', 'Gait disturbance', 'Headache', 'Pain in extremity', 'Vertigo']",2,PFIZER\BIONTECH,SYR 1046831,FL,42.0,M,"Headache, low grade fever, chills, body aches, and injection site pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,PVT,Lisinopril Singular Lipitor,,"Hypertension, High Cholesterol, and Seasonal Allergies",,NKDA,"['Chills', 'Computerised tomogram head normal', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",2,MODERNA,IM 1046832,,27.0,F,"Near syncope, evaluated by EMS -dizzy, lightheaded. BP 128/72. Monitored for 30 minutes, symptoms resolved. Discharged home at 1:30 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,,,,,,"['Dizziness', 'Presyncope']",2,MODERNA,IM 1046833,NC,78.0,F,"On 2/19/2021, 78yr old female with history of asthma, diverticulitis, GERD, hiatal hernia, HTN, and hyperlipidemia was administered second dose of COVID-19 Pfizer vaccine 0.3mL in left deltoid (LOT # EN6201). Patient has several documented allergies including dextromethorphan (anaphylaxis), guaifenesin (anaphylaxis), olmesartan (itching), erythromycin (unknown), hydrocodone (unknown), atorvastatin/pravastatin/rosuvastatin (muscle pain), codeine (throat swelling), shrimp (hives, itching). Patient received first dose of COVID-19 Pfizer vaccine on 1/27/21 without any documented issues. Patient initially tolerated injection without incident and was sent for post-injection 15min observation. During 15min observation period, patient became dizzy, diaphoretic, nauseated, and unable to walk with steady gait, hypertensive and endorsed hives. EMS called and patient sent to ED. During initial presentation to ED, BP 180/80, HR 85, and 97% on RA. Patient given Benadryl 25mg PO and ondansetron 4mg IVP at 2055. 1L LR bolus given at 2059. BP lowered during ED observation (BP 160/80 on 2/20 at 0442). Acetaminophen 650mg PO given at 0442 prior to discharge. Patient discharged home in stable condition ~ 0500 on 2/20 with plan for patient to follow up with outpatient provider. EpiPen was not prescribed at discharge. No update to EPIC allergies noted at this time. Of note, reporter notes unable to check POC BG at clinic (glucometer unavailable). Patient has no history of diabetes, but noted that has similar ""episodes"" with low BG. EMS checked BG (POC = 144).",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,PVT,"acetaminophen, amlodipine, albuterol, fluticasone nasal spry, lidocaine patch, senna, pantoprazole, rosuvastatin, tramadol, triamterene-hydrochlorothiazide",unknown/none,"asthma, diverticulitis, GERD, hiatal hernia, HTN, and hyperlipidemia",,"dextromethorphan (anaphylaxis), guaifenesin (anaphylaxis), ol dextromethorphan (anaphylaxis), guaifenesin (anaphylaxis), olmesartan (itching), erythromycin (unknown), hydrocodone (unknown), atorvastatin/pravastatin/rosuvastatin (muscle pain), codeine (throat swelling), shrimp (hives, itching)","['Dizziness', 'Gait inability', 'Hyperhidrosis', 'Hypertension', 'Nausea', 'Urticaria']",2,PFIZER\BIONTECH,IM 1046834,WA,71.0,M,Fatigue 2-16-21 : 2-18-21,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,PVT,Synthroid Flomax Omeprazole Mirtazapine,,,Shingles,,['Fatigue'],UNK,MODERNA, 1046835,VA,65.0,M,"experienced epistaxis 2-3 x daily for approx 3 weeks, self ordered platelet count and it dropped significantly since 12-31-2020 and last blood work. Currently the frequency has slowed down.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/25/2021,3.0,PVT,lipitor,,ITP,,tetracycline sensitivity,"['Epistaxis', 'Platelet count decreased']",1,MODERNA,IM 1046836,AK,50.0,F,"Arm turned red, swelled, and itched like a bug bite around the injection site that happened about 7 days after 1st shot and lasted about 72 hours . I have three red marks remaining that look like scratched.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/17/2021,7.0,MIL,"vitamin d, probiatic, levothyroxine, sertraline. Lisinopril",none,"depression, high blood pressure, thyroid",,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site streaking', 'Injection site swelling']",UNK,MODERNA,SYR 1046837,CA,95.0,F,"patient complained stomach pain, responsive but lethargy and slightly clammy. Vital Signs: BP 112/45; pulse 41; O2 Sat 99 - 100%. Bradycardia patient put on gurney, heart monitor, started IV lock. transferred to ED for further evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,UNK,,,,,,"['Abdominal pain upper', 'Bradycardia', 'Cardiac monitoring', 'Cold sweat', 'Lethargy']",2,MODERNA,IM 1046838,IN,75.0,M,"Local redness and warmth at injection site, about 2-3 inches in radius around the site. Occurred approx. 5 days after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/20/2021,5.0,PUB,"fenofibrate 48 mg PO daily, loratadine 10 mg PO daily, losartan potassium 50 mg PO daily, metoprolol tartrate 20 mg PO once in AM and twice in PM, nystatin 100000 units/gm ointment applied BID, omeprazole 40 mg daily, tizanidine 4 mg PO da",GERD,Hypertriclyceridemia,,No known allergies,"['Injection site erythema', 'Injection site warmth']",2,MODERNA,IM 1046839,KY,81.0,M,"Patient is a 81 y.o. gentleman with a history of smoldering multiple myeloma, urinary retention for which he self catheterizes twice daily, as well as recently diagnosed atrial fibrillation that presents complaining of increasing weakness and falls. Patient fell 2/18 pm trying to get out of bed and he took about 20 minutes to get himself to a position where he could pull himself back up. Again 2/19 he was trying to get up and his legs were too weak to carry him and he fell to the ground. He needed assistance to get up and family asked him to come to emergency room for evaluation. He has been feeling poorly for about a month, with poor appetite and has lost about 15 pounds. He is not nauseated or short of breath and has no cough. He was apparently treated for UTI about 4 to 6 weeks ago after a visit to urgent care. He has since been to a different urgent care and was diagnosed with atrial fibrillation which was new in onset and was referred to a cardiologist who is planning to do a stress test in a few weeks. I believe he is on Eliquis now. In ER he was found to have significant pyuria and bacteriuria and was given a dose of Rocephin. Renal function shows worsening from levels in December although it is pretty stable over the past month from looking through other labs.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/18/2021,02/19/2021,1.0,PVT,"Apixaban 2.5mg PO q12h, cholecalciferol 2000units po qday, Cyanocobalamin, Fluticasone 220mcg/act 1 puff qam, ipratropium 0.06% 2 sprays each nostril bid, loratadine 10mg qday, Montelukast 10mg qhs, oxymetazoline 0.05% 2 sprays each nostril",,"Smoldering myeloma, atrial fibrillation, urinary retention",,"ibuprofen, latex","['Asthenia', 'Bacteriuria', 'Blood creatinine increased', 'COVID-19', 'Fall', 'Mobility decreased', 'Muscular weakness', 'Pyuria', 'Renal impairment', 'SARS-CoV-2 test positive', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 1046840,CA,60.0,F,Rash and itchiness at site. Chills and body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,PHM,None,None,None,,None,"['Chills', 'Injection site pruritus', 'Injection site rash', 'Pain']",UNK,MODERNA, 1046841,OH,51.0,F,"Difficulty swallowing within minutes of vaccination. no progression of this symptom and also developed a mild headache to base of skull. chest feels a little tight. 12.5 mg of Benadryl given about 30 minutes in to observation. After another 50 minutes, headache gone, chest pressure less, and swallowing improved. patient advised to return to ED if symptoms returned or worsened.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PVT,vitamins,platelet deficiency,Renaud's,,"pcn, erythromycin, inderal, sunthetic hormones","['Chest discomfort', 'Dysphagia', 'Headache']",2,PFIZER\BIONTECH,IM 1046842,AZ,65.0,F,Began feeling an itchy throat,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/17/2021,0.0,PUB,"Metformin, atorvastatin,",,"Diabetic, high cholesterol",,Codeine,['Throat irritation'],1,MODERNA,IM 1046843,,56.0,F,"2nd covid vaccine afterward extremely fatigued and arm soreness for days. On 2/16/21 at 5am, left side weakness in my arm tingling and numbness in my fingers and toes very weak.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/13/2021,02/16/2021,3.0,PVT,,,,,,"['Asthenia', 'Fatigue', 'Hemiparesis', 'Hypoaesthesia', 'Pain in extremity', 'Paraesthesia']",2,MODERNA,IM 1046845,VA,84.0,F,Deceased 02/18/2021 with an unknown cause of death,Yes,02/18/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/18/2021,1.0,OTH,,,,,,['Death'],2,MODERNA,IM 1046846,MD,59.0,F,Rash with severe itching to L upper arm that started approximately 6 days after receiving the vaccine. I continue to have the rash and itching . Today is 2/22.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/17/2021,6.0,UNK,"Lipitor, Vit D, Fyavolv, Zyrtec",,,,"Benadryl, Vicodin","['Injection site pruritus', 'Injection site rash']",2,MODERNA,IM 1046847,AZ,44.0,F,"Several hours after shot, arm soreness and redness - next few days very sore arm, large red round raised splotch on arm - hot to the touch - 3rd day arm was less sore, red turned to black and blue bruise looking, 4th day arm clear. On 8th day, large red round splotch re-appeared is hot to the touch and itchy - still there day 10.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,PVT,Propranolol Zyrtec Vitamin C Vitamin D Vitamin B12 Magnesium,none,essential tremors,,minor milk and pork allergy,"['Contusion', 'Erythema', 'Pain in extremity', 'Pruritus', 'Rash macular', 'Skin warm']",1,MODERNA,SYR 1046848,IL,65.0,M,"Long term care facility closely monitoring patient. Given three doses of Covid - Pfizer dose, 01/07/21, 01/28/21, 02/18/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,PHM,Unknown,Unknown,Unknown,,Unknown,['Extra dose administered'],3,PFIZER\BIONTECH,IM 1046849,MI,48.0,F,"Patient phoned pcp office Clinic to inform: receipt of 2nd Moderna vaccination at HD on 2/18/21, patient states on 1st evening felt numbness and tingling in tongue, as well as fatigue, body aches, chills, but took benadryl and no worsening s/s. Typical side effects of body aches, chills, sore joints continued throughout day 2 and day 3. On day 3 patient reports she developed a rash on her neck and swollen eyes. Reported information to pcp NP for advisement today.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,PUB,Berberine complex metformin 500 mg BID albuterol hfa 108 prn flaxseed oil 1000 mg daily flonase NS prn zyrtec 10 mg daily prn b complex daily cayenne pepper po daily multivitamin daily vitamin c 1000 mg tab daily iron every other day vitami,none noted,vit d def. seasonal allergies polycstic ovarian syndrome obesity fatigue conjunctivitis allergic rhinitis acne,,cephalexin celexa contraceptives pcn shellfish,"['Arthralgia', 'Chills', 'Fatigue', 'Hypoaesthesia oral', 'Pain', 'Paraesthesia oral']",2,MODERNA,IM 1046850,NY,73.0,M,"It started with shaking and feeling cold. it lasted about an hour. I could not stop shaking. my temperature was 103.5. I had trouble walking, I had fatigue and tiredness. My arm hurt up to the base of my neck. I had pain urinating. my fever lasted about 12 hours. It did go away by 2/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PHM,Norvasc Ramipril Gabapentin alopurinol Simvastatin Vitamins: D C Zinc,No,Heart condition,,No,"['Dysuria', 'Fatigue', 'Feeling cold', 'Gait disturbance', 'Neck pain', 'Pain in extremity', 'Pyrexia', 'Tremor']",1,MODERNA,SYR 1046851,OK,70.0,F,"night after injection I got rash and hives all over the body. Neck eyes, arms legs, thighs and butt, back, pretty much everywhere. I have taken Benadryl and it is not helping a whole lot. Called the Dr but i have not heard back yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,PUB,"thyroid meds, allergy meds, Cingular, astatine, Prilosec, Pepcid,",,asma,Shingles at age 69 or 70 i got a rash on the front and on my trunk. I got it a year ago,antibiotics,"['Rash', 'Urticaria']",2,MODERNA,SYR 1046852,LA,87.0,F,"No problems after shot until 12 hrs later. Then chills, fever bad headache, nausea for 2 days. Took Tylenol and stayed in bed",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/13/2021,1.0,PHM,"Synthroid, valsartan 80 mg,eliquis 2.5 mg, metropolol 25 mg, pantoprazole 40, vitamins B,C, D,",Slight cold,I had COVID in early July 2020. Was really sick for 2 weeks.,,Codeine,"['Chills', 'Headache', 'Nausea', 'Pyrexia']",UNK,MODERNA, 1046853,TX,34.0,F,site pain and headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/03/2021,1.0,PVT,UNK,UNK,UNK,,UNK,"['Headache', 'Injection site pain']",2,MODERNA,IM 1046854,MA,60.0,M,1/6 18 days after the vaccination I woke up with floaters in my right eye. Much more developed throughtout the day. The next day Thursday I had a visual deficite in my eye along with the floaters. By Friday evening I went up to see the eye doctor while at work and was advised I had 5 tears to the retina of my right eye and was advised it needs to be repaired immediately. On 1/9 I had a vitrectomy and the tears in the retina were repaired as well. I was advised the surgery had an 85% success rate but advised I will develop a cataract in the eye within 6months but within 6 weeks it developed. 2/22 I had the cataract removed and a lense replaced in my right eye.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/18/2020,01/06/2021,19.0,PVT,"Aspirin 81mg, 80mg Lipitor, 5mg Amlodipine, Liviotyrozine, Losartan 100mg",no,"Coronary Artery Disease, Hypertension, High Cholesterol, Hypertyroidism, Perpherial Vascular Disease, History of Oropharangeal Cancer",polio??-1990s-vaccine failure,no,"['Cataract', 'Cataract operation', 'Retinal operation', 'Retinal tear', 'Visual impairment', 'Vitrectomy', 'Vitreous floaters']",1,PFIZER\BIONTECH,IM 1046855,AZ,68.0,F,"Just before falling asleep on day seven, my left upper arm was itchy, but thought nothing of it and went to sleep. The next morning I noticed a large red, oval lesion around the place where I had the vaccine shot. The rash appears to be fading slowly from the center out.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/20/2021,7.0,PHM,"Bio-identical hormones: estrogen, progesterone, testosterone, DHEA Sumatriptan as needed for migraine. I can't remember, but I might have taken this the night the itchy rash started. Vitamins: Multi-vitamin, Hyaluronic Acid, B-complex with",,Thyroid nodules,,,"['Injection site erythema', 'Pruritus', 'Rash']",1,MODERNA,IM 1046856,MD,87.0,M,"Patient was admitted for AMS, possible UTI. Patient also tested positive for COVID-19 at this time. He stayed overnight, was felt to be stable and was discharged. He was readmitted 1 day later under observation for weakness, treated, and discharged to a nursing home",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,02/11/2021,02/12/2021,1.0,PVT,,,"CAD, dementia, GERD, Parkinson's",,Sulfa antibiotics (itching),"['Asthenia', 'COVID-19', 'Mental status changes', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1046857,TX,70.0,F,"Felt fine at first, but then suffered flu-like symptoms including extreme fatigue, stomach discomfort, gas, nausea, loss of appetite, acid reflux. Some symptoms have ceased or lessened, but extreme fatigue, lack of appetite and some stomach discomfort and acid reflux discomfort continues.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/07/2021,1.0,OTH,"Irbestartan/hctz 300-12.5mg, Lovastatin 10 mg, Restasis emu 0.05%, potassium CL ER 10 MEQ Micro tab, D 1000iu, Calcium 600mg, B-12",Food poisoning one or two weeks before.,"High blood pressure, high cholesterol",,"Potentially another statin, probably Crestor","['Abdominal discomfort', 'Decreased appetite', 'Fatigue', 'Flatulence', 'Gastrooesophageal reflux disease', 'Influenza like illness', 'Nausea']",1,PFIZER\BIONTECH,SYR 1046858,IL,33.0,F,"Patient was being held for monitoring after receiving the COVID-19 vaccine. Within 1-2 minutes, patient developed facial redness and itching. She then started to feel as if her throat was itchy and started coughing uncontrollably. Denied lip or tongue swelling. Was feeling normal prior to receiving the vaccine. Was not recently seen/assessed for other medical care. No similar symptoms previously. Patient was taken to the Emergency Department. Ptaient did have a few red splotches on her chest, but these did not appear consistent with urticaria per the ED physician's report. ED physician felt patient's symptoms may be secondary to anxiety. However, given history of anaphylaxis and feeling of throat itching it was felt necessary to treat for possible allergic reaction. Patient was given epinephrine, Benadryl, famotidine, and Solu-Medrol. She was then monitored in the ED for 4 hours. During this time, she developed no new symptoms. She continued to breathe easily with normal and stable vital signs. She was discharged with instructions to buy OTC Benadryl 25mg PO to take every 8 hours for 48 hours. Prednisone 20mg, 3 tablets orally daily for 5 days weas prescribed. An EpiPen was also prescribed. Patient advised not to receive second dose of the vaccine and to follow up with her primary care provider.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PVT,Omeprazole,None,Polycystic Ovary Disease Endometriosis GERD,,"Cephalexin, Cyclobenzaprine, Meloxicam, traMADol","['Anxiety', 'Cough', 'Erythema', 'Pruritus', 'Rash macular', 'Throat irritation']",1,PFIZER\BIONTECH,IM 1046859,CA,73.0,F,Large red swelling and itching in arm where injection was given. lasted about 3 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/25/2021,2.0,PHM,no,no,no,,none,"['Erythema', 'Peripheral swelling', 'Pruritus']",UNK,MODERNA,IM 1046860,CA,41.0,M,"Pain at injection site, High Fever 101.5 lasting 24 hours, Whole body pain, Barely able to walk",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,,,,Pain at injection site for 4 days,,"['Injection site pain', 'Pain', 'Pyrexia']",UNK,MODERNA, 1046861,KY,46.0,M,"A few hours after injection, injection site became very sore, started running a fever, HA, body aches, malaise, inability to sleep well. The worst lasting for 3 days. Could not go to work. Loss of appetite.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,PVT,citalopram,no,no,,no,"['Decreased appetite', 'Headache', 'Impaired work ability', 'Injection site pain', 'Malaise', 'Pain', 'Pyrexia', 'Sleep disorder']",1,MODERNA, 1046862,NY,75.0,M,"chills, fever, severe weakness, nausea, incontinence - began approcimately 12 hours following the vaccine and were severe for approximately 20 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PHM,"fish oil. calcium, potassium, b-12, memantine, donepezil, metoprolol",no,"diabetic - insulin dependent - 51 years, celiac disease - 35 years",,kefllex,"['Asthenia', 'Chills', 'Incontinence', 'Nausea', 'Pyrexia']",UNK,MODERNA, 1046863,CT,48.0,F,"Chills, fever, severe body pain, severe fatigue, light-headed, symptoms lasted for about 36 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PVT,"singulair,advair,dupixent,multivitamin,calcium,iron,vit d",,"asthma, nasal polyps",,"asprin, motrin","['Chills', 'Dizziness', 'Fatigue', 'Pain', 'Pyrexia']",2,MODERNA,IM 1046864,OH,33.0,F,"First 2 days I had high fever, nausea, vomiting, chills, shaking, migraine, fatigue, and body aches. It is one week after my second injection and I still have severe fatigue, body aches, sore throat, nausea, headache, and swollen lymph nodes.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/15/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Influenza virus test negative', 'Lymphadenopathy', 'Migraine', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Streptococcus test negative', 'Tremor', 'Vomiting']",2,MODERNA,IM 1046866,VA,66.0,F,"Rash beginning on upper left arm near injection site, spreading to face, chest, right art, hands and back. Much like an allergic reaction to poison ivy. I cannot pinpoint to any other change in diet, laundry detergent, soap, etc. I am treating with Benadryl and cortizone cream but some whelps are still itchy 2 days later. I am better but not completely gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/20/2021,9.0,PVT,"Fenofibrate Tabs 145mg, Hydrochlorithiazide 12.5mg, Amlodopine Besylate 10mg, Fish Oil 1000mg, Aspirin 81mg, Melatonin 6mg, Vitamin D3 50 mg, Calcium 1200 mg",none,"High blood pressure and triglycerides, eczema",,sulfur,"['Dermatitis contact', 'Injection site rash', 'Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 1046867,KY,45.0,M,PATIENT STATES HE CAME HOME FROM WORK. STATES HE SAT DOWN IN THE RECLINER WITH A GATORADE TO DRINK. STATES HE GOT CHOKED ON THE GATORADE AND STARTED COUGHING. STATES THAT THE NEXT THING HE REMEMBERS IS HIS WIFE TRYING TO GET HIM AWAKENED. STATES THAT HE FEELS FINE NOW. HE SAYS THAT HE FEELS TIRED BUT HAS BEEN SINCE HE HAD COVID.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PUB,"FENOFIBRATE, BLOOD THINNER (UNKNOWN NAME), PRILOSEC, LISINOPRIL, METFORMEN, ZYRTEC, INVOKANA",DX WITH COVID ON 01/20/2021; HOSPITALIZED ON 01/25/2021; RELEASED ON 02/01/2021.,"HTN, DM, HYPELIPIDEMIA, AND NEUROMUSCULAR DISEASES",,PCN AND STATINS,"['Choking', 'Cough', 'Fatigue']",1,MODERNA,IM 1046868,TX,60.0,F,"Communication Comment: ""Patient present in clinic for COVID-19 vaccine. Patient reported feeling something"" going up and down her neck"" about 15 mins after vaccines was administered. Blood pressure reading was obtained, elevated at 188/100, HR 100. She reported new symptoms of dry throat causing tightness sensation and numbness in tongue. Patient was given Benadryl 25mg PO and water and observed for an additional 40minutes. Her symptoms resolved including throat dryness, tongue tingling, throat tightness. Denies dizziness, rash, difficulty swallowing, hoarseness, chest pain. Vital signs improved. She reports she has blood pressure medicine at home that she was advised to take only when needed. She did not take medication today. She does not know the name of medication. Declined prescription of blood pressure medication today, agreed to take medicine she has at home and return to clinic for appointment Friday, 2/12/2021. Patient given strict ER precautions if her symptoms continue, worsen or if she develops new symptoms.""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,PVT,None,,High Cholesterol,,NKDA,"['Blood pressure increased', 'Dry throat', 'Feeling abnormal', 'Hypoaesthesia oral', 'Paraesthesia oral', 'Throat tightness']",1,MODERNA,IM 1046870,FL,70.0,F,"5-7 days after injection Rash, altered mental statues, shortness of breath",Not Reported,,Not Reported,Yes,,Not Reported,N,02/09/2021,02/15/2021,6.0,PUB,"synthroid150 mcg , oxycodone 10 mg , gabapentin 3000 mg , benadryl, ROSUVASTATIN 10 MG ORAL TAB, albueral ,",None,"Underactive thyroid, DM. HLD, Asthma,",,PCN,"['C-reactive protein', 'Chest X-ray', 'Computerised tomogram head', 'Computerised tomogram thorax', 'Drug screen', 'Dyspnoea', 'Electrocardiogram', 'Fibrin D dimer', 'Mental status changes', 'N-terminal prohormone brain natriuretic peptide', 'Rash', 'Red blood cell sedimentation rate', 'Thyroid function test']",1,MODERNA,IM 1046871,NC,64.0,F,"""Swollen, delayed, red, hive type but not a hive, grew bigger as time went by and lighter in color."" Size description: ""Length and width of a dollar bill. Started where the shot was and spread. By Sunday the color was gradually fading. No burning or itching. Wouldn't have noticed if I hadn't looked in the mirror. Up until 02/20/2021 there had been no reaction of any kind."" As of today, 02/22/2021, she states"" it is a pinkish color and has spread from shoulder to elbow. I went on the internet and found out that it's called ""COVID ARM""""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/20/2021,9.0,PUB,Estradiol 1 mg po QHS Fexophenadine 180 mg po QD Tylenol 650mg ER 2 tabs po Q AM; Metamizole 10mg 1 tab PO QAM,Denies illness,Hyperthyroidism,,NKDA:NKFA,"['Erythema', 'Injection site erythema', 'Injection site swelling', 'Injection site urticaria', 'Swelling', 'Urticaria']",1,MODERNA,IM 1046872,IL,61.0,F,There was an attempt to give me the 2nd dose of vaccine by a student nurse. When she attempted to give it to me the liquid of the vaccine dripped down the entire length of my arm and onto the floor. I pointed it out to her. She called her teacher over and then the Dr. at the site talked to me. He said that they are not authorized to give a 3rd vaccine. I said I did not get the 2nd vaccine as it dripped down my arm and he witnessed this. The Dr. continued to state that they could not give me a 3rd vaccine and I continued to state I did not receive the 2nd vaccine as it ran down my arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,"D3, Multivitamin",none,none,,no,"['Exposure via skin contact', 'Syringe issue', 'Underdose']",1,MODERNA,IM 1046873,NE,72.0,F,"Patient received her first dose of the Moderna Covid-19 vaccine on 1/20/21. She then reported 28 days later on 2/17/21 to the wrong site for her second dose. The site to which she reported was a Pfizer-only vaccine clinic. At this Pfizer clinic, she was administered a Pfizer vaccine as her second dose. This error was discovered by clinic staff in our observation area when the patient looked at her vaccination record card and saw that she had received Pfizer for her second dose and not Moderna. Patient was monitored for the normal length of time (15 minutes) and displayed no adverse events during this period. Patient was informed of the error and left after her 15 minutes was completed. Patient was informed that a VAERS report would be filed on her behalf and that, per the CDC instructions, she would not need to get any additional doses to complete her series.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PUB,unknown,unknown,unknown,,"per patient screener, no hx of anaphylaxis; unknown if any milder allergies","['Interchange of vaccine products', 'No adverse event']",2,PFIZER\BIONTECH,IM 1046874,TN,81.0,F,RESIDENT HAD RASH THAT WAS ON BODY AND HEAD BOTH ARMS. RASH WAS RED AND ANGRY IN NATURE. ITCHING OCCURRING BEFORE RASH APPEAR,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/11/2021,2.0,SEN,"ZYPREX, CALCITONIN,CLONAZEPAM,LEVETRIACETAN.NEUDEXTA, NUPLAZID,EXELON PATCH, TEGRETOL,LACTULOSE,LORITAB, XIFAIN,OMEPRAZOLE,LINSINOPRIL, TRAZADONE,STATIN, ASA, LEVOTHROXINE AMOLIDPINE, FERROUS SULFATE, CARBAMAZEPIN, MAGNESIUM, D3 SINEMET",NONE EXCEPT YEAST IN PERI AREA,"PARKINSONS, dm11, SCHIZOPHRENIA, PSEUDOBULBAR EFFECT, DYSPHAGIA,HEPTIC FAILURE, GI BLEED, PERICARDIAL EFFUSION, ACUTE KIDNEY FAILURE, IRON DEFICENCY HYPOKALEMIA, CHRONIC PAIN SYNDROME, VASULAR DEFICENCY",,VALIUM,"['Erythema', 'Liver function test normal', 'Pruritus', 'Rash']",2,MODERNA,IM 1046875,MD,61.0,F,"Day 1 after the vaccination: very strong pain in the arm to the extent that I was unable to reach anything above a shoulder level (so much worse than the 1st shot), surprisingly little swelling though (so much better than the 1st shot). Increasing fatigue which maxed around 11am accompanied by cold shivers and increased body temp . Fever picked at 5pm to 101.3F. By 10pm fever and fatigue were gone! Day 2 after the vaccination: a red rash size 2 inch x 3 inch on the arm around the place of the injection, pain in the arm was nearly gone, no fever, no fatigue. Day 3 after the vaccination: red rash is gone. Back to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,WRK,"vitD3, calcium, chondroitin+glucosamine",,"osteoporosis, IBD",,"milk(casein),","['Chills', 'Fatigue', 'Injection site rash', 'Joint range of motion decreased', 'Pain in extremity', 'Pyrexia', 'Rash erythematous']",2,MODERNA,IM 1046876,CA,67.0,F,Scabs at and around the injection site that didn't appear until several days after injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/16/2021,5.0,OTH,"Zoloft, Vitamin D3, Advil and Excedrin",,,,Penicillin,['Injection site scab'],1,PFIZER\BIONTECH,SYR 1046877,OH,84.0,F,"Developed fever and vertigo, room spinning 1 day after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,SEN,Amitriptyline,,Hypothyroidism Migraines,,Actonel Amoxicillin Bactrim Ciprofloxacin Loratadine NSAIDS Perfumes Adhesive Tape,"['Pyrexia', 'Vertigo']",2,PFIZER\BIONTECH,IM 1046878,MI,41.0,F,Injection site pain started 30 minutes after injection. Arm pain that impacted range of motion of left arm for 3 days. Resolved 96 hours post injection,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PUB,"Nexium, Lexapro, propranolol ,",,"Migraine, GERD,",,Mango,"['Injected limb mobility decreased', 'Injection site pain']",1,MODERNA,SYR 1046879,FL,68.0,F,Pt. in tent 4 at 2:31 at observation lane was reporting throat tightness and headache. Paramedics assessed vitals. Bp 210/115. Paramedics and Pt. wanted her to go to the hospital. Emergency services was called. She was transported.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,UNK,"Metropidol, icrozole",,"NTn, Breast cancer",,"shellfish, insinpril","['Headache', 'Throat tightness']",1,PFIZER\BIONTECH,IM 1046880,NJ,87.0,F,"Feb. 10th, vaccine given in the morning. Sore arm at injection site that night and the next day. Feb 11th, one time episode of projectile vomiting bile? Feb. 19th, non erythematous rash started on back of the neck only and not itchy. Feb 20th, widespread significant erythematous rash at the front and back of the torso only w itchiness. Feb. 21st, rash extended to the groin, vulva, arms, legs, and face. Still itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/19/2021,9.0,PUB,"Methylprednisolone 2mg every Tuesday, Thursday, and Saturday Triamterene-HCTZ 37.5-25mg once a day Furosemide 20mg every Monday, Wednesday and Friday Calcium 600mg once a day Metoprolol 50mg once a day Vitamin D3 1000IU once a day Atorvast",None,"Asthma, High blood pressure, Angina, Polymyalgia rheumatica, Glaucoma, Spinal stenosis, Decreased bone density",,"Scallops, Penicillin","['Blood test', 'Injection site pain', 'Rash', 'Rash erythematous', 'Rash pruritic', 'Vaccination complication', 'Vomiting', 'Vomiting projectile', 'Vulvovaginal rash']",1,MODERNA,IM 1046881,CA,91.0,F,Code blue called at 11:00pm. Patient had code status of Do Not Resuscitate.,Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,PVT,"Carvedilol, Gemfibrozil, Ferrous Sulfate, Folic acid, metoclopramide, mvi, pravastatin, digoxin, clonazepam, Senna, bisacodyl, docusate, memantine, rivastigmine, linaclotide, lansoprazole, fish oil, clonidine, amlodipine, losartan,",UTI,"CHF, CKD, MI, Encephalopathy, Aortic stenosis",,NKA,['Cardio-respiratory arrest'],1,MODERNA,IM 1046882,MD,80.0,F,Patient was admitted and treated for a small bowel obstruction,Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,02/04/2021,02/13/2021,9.0,PVT,"acetaminophen, apixaban, digoxin, diltiazem, docusate, lovastatin, trospium",,"Hx of breast cancer, hypercholesterolemia, osteoarthritis, hypothyroidism, hypertension, atrial fibrillation, peripheral neuropathy, diabetes mellitus type 2, reflux esophagitis, trigeminal neuralgia",,atorvastatin (syncope),['Small intestinal obstruction'],1,MODERNA,IM 1046883,GA,91.0,F,within 24 hours circular brown spots about the size of a quarter and the color of a dark bruise appeared on both arms and at top of one leg; spots were not painful and did not itch. they are ongoing,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,PUB,"amlodipine, metoprolol, pravastatin, Phillips Colon Health, PreserVision,vitamins D3, B6,B12, aspirin",none,"neuropathy in extremities, arthritis",,shellfish,"['Blood test', 'Contusion']",1,MODERNA,UN 1046884,MO,31.0,F,"rash and raised skin around injection site, itchy, red on 2/20 at 10pm; took some bennedryl allergy orally, lessend symptoms, but did not eliminate. 2/21 - more red, hot around area, itchy, but not as bad as the day before. 2/22 - still slightly itchy, a little less red, still pretty raised and warm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,OTH,"ibuprofen, marijuana, magnesium, merena IUD",,,,penicillin- rash,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site warmth']",2,PFIZER\BIONTECH,SYR 1046885,AK,68.0,F,"injection site pain, body ache , headache, stiff neck, dizziness, chills, swollen lymph glands in underarm area. acetaminophen 1000mg every 8 hours was effective for pain relief . bed rest",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,LEVOTHYROXINE 125 MCG ROSUVASTATIN 10 MG ESOMEPRAZOLE 40MG VITAMIN D MULTI VITAMIN,,,injection site pain from flu vaccine,,"['Chills', 'Dizziness', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Musculoskeletal stiffness', 'Pain']",2,PFIZER\BIONTECH,IM 1046886,MN,38.0,F,Excessive migraine. 5 days out of 7. Regular treatments not working.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/13/2021,2.0,PVT,,None,"Anxiety, depression, migraine",,"Aloe, latex, metal","['Condition aggravated', 'Migraine']",1,MODERNA,IM 1046887,IA,66.0,F,"8 days following vaccine developed itchy, redness at injection site...newspaper accounts refer to this as Covid Arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/20/2021,8.0,PUB,Amlodipine Besylate 5mg Chlorthalidone 25 mg Metoprolol Succinate ER 50 mg Multivitamin Low Dose Aspirin Calcium Tablet with Magnesium & Zinc,,High Blood Pressure High Cholesterol,,Sulfa,"['Injection site erythema', 'Injection site pruritus']",UNK,MODERNA, 1046888,WA,38.0,M,Patient reported metal smell,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/20/2021,2.0,PVT,none,none,none,,none,['Parosmia'],1,MODERNA,IM 1046889,,43.0,F,"Dizzy, lightheaded, tingling right hand, (non-injection side), cold feeling shooting down left arm (injection arm). Evaluated by EMS- at 12:09 pm. BP 132/84. 12:17pm dizziness resolving. 12:30 pm client feeling much better and discharged home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,,,,,,"['Dizziness', 'Paraesthesia', 'Peripheral coldness']",2,MODERNA,IM 1046890,CA,69.0,F,"Chills, body aches, fever, sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,UNK,None,None,High cholesterol,,Penicillin,"['Chills', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH, 1046891,CA,65.0,F,"Day 7 post injection left arm injection area itchy, slightly red, swollen, mild pain. Area covering 2 inches by 2 inches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/21/2021,7.0,PHM,"Atorvstatin, duloxetine, Prolia (every 6 months), acyclovir, levothyroxin, food grade Calcium , food grade Vit. D, food grade Vit. C, probiotic, food grade turmeric , CO q10, Omega 3 fish oil",None,"Celiac disease, hypercholesteremia, borderline diabetes , hypothyroidism, osteoporosis",Tetanus Toxoid Horse Serum. 1975?,"Penicillin , levaquin","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA,IM 1046892,TX,59.0,F,Body aches and congestion after vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,PVT,"Lisinopril-HCTZ 10-12.5 mg daily, Paroxetine 20 mg daily",Patient does report having a cough prior to vaccination,Hypertension,,None reported,"['Pain', 'Respiratory tract congestion', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,SYR 1046893,NY,55.0,M,"Light-headed (foggy, not dizzy). Difficulty taking deep breaths/ getting a full breath.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,SCH,"Low-dose aspirin, daily, daily multi-vitamin (One-a Day) Fish Oil 500 MG, Saw Palmetto.",None,None,"Fever, headache (Moderna Covid Vaccine)",None,"['Dizziness', 'Feeling abnormal', 'Hypopnoea']",2,MODERNA,UN 1046894,NY,72.0,F,Itching and redness at injection site. Area approx 5 cm in diameter. Feels warmer to the touch than surrounding areas.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,PHM,Levothyroxin 100 mcg lithyronine 5 mcg Vitamin D3 25 mcg Docusate sodium 250 mg Rosuvastatin 5 mg budesonide formoterol 80 mcg/4.5mcg,none,Hypothyroidism Sleep apnea emphysema,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 1046895,TX,26.0,F,"Dose 1: Headache, body aches, fever, fatigue and vomiting Dose 2: Chills, headache, joint aches, muscle pain, diarrhea,nausea, vomiting, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,UNK,UNK,UNK,,UNk,"['Arthralgia', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,MODERNA,IM 1046896,CO,72.0,F,"very achy muscles, headache lasted over a week, tired",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/12/2021,7.0,PVT,levothroxine- losartin - hydrochlorothiazide-glimepiride-ezetimibe-januvia vit D-B12-biotin-calcium/mag-collagen-probiotics-zyrtec-,no,"blood pressure,high cholestrol, diabetes",,keflex,"['Fatigue', 'Headache', 'Myalgia']",1,PFIZER\BIONTECH,SYR 1046897,WA,73.0,F,"At about 2 pm, 2-19-2021, I became very light-headed rather suddenly, and could barely stand up or walk. (A trip from my bed to the bathroom was difficult.) This proceeded to severe nausea (I retched into the. toilet bowl a couple of times and came close to vomiting). I dosed in bed and the severity of the symptoms eased, but I really haven't felt completely over it until today (2-22-2021).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,SEN,"Atorvastatin, Bupropion, Diltiazem, Escitalopram, Lisinopril , Metformin,Mirtazapine, Trazodone, Gabapentin, Lorazepam, Pramipexole",None,"I have recurring major depression, currently in remission, with intermittent anxiety attacks. I take medications for these. I have peripheral neuropathy in both hands and feet, causing numbness and pain. I have diabetes and hypertension, and I am obese.","Age 73, Vaccination 2-18-2021, Covid-19 vaccine, Moderna. Similar to the above, but came on three days after the vaccination.","Codeine, valium, sulfa, Keflex, Topomax","['Dizziness', 'Dysstasia', 'Gait inability', 'Nausea', 'Poor quality sleep', 'Retching']",UNK,MODERNA,IM 1046898,MI,50.0,F,"Within one minute of vaccination, patient was flushed, light-headed, dizzy, itching, and tingling down right side. Also had mild muscle aches and a headache. Had a similar reaction on her first dose. Oxygen: 97% on room air, BP109/57 and HR 54. Pt declined Benadryl and was taken to ED for further evaluation,",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PVT,"allegra, baclofen prn, eye drops",,migraines,,mild bee stings,"['Dizziness', 'Flushing', 'Headache', 'Myalgia', 'Paraesthesia', 'Pruritus']",2,PFIZER\BIONTECH,IM 1046899,OH,,M,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/12/2021,1.0,PUB,"Lisinopril, Pravastitin, Fish oil, Vitamin C",Covid 19,High B/P and high cholesterol,,none,['Unevaluable event'],1,PFIZER\BIONTECH,IM 1046900,MI,24.0,F,"Pregnancy Info: -Healthy pregnancy, velamentous cord insertion only complication -Due date: 3/3/21 -Induction set for 2/24/21 Adverse Event: -Rash around injection site. Began one day after injection and went away, then returned 7 days post-injection. Red and itchy, non-painful round rash of around 4 cm diameter around injection site. Upon return, the rash lasted about 4 days. Rash was warm to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/04/2021,1.0,PUB,-Fludrocortisone -prenatal vitamin -Vitamin B6 -Unisom -Zyrtec -Riboflavin -Magnesium,,Neurocardiogenic Syncope,,,"['Exposure during pregnancy', 'Injection site reaction', 'Injection site warmth', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,SYR 1046901,VA,21.0,F,"Pruritis, hives, no airway issues. Given solu-MEDROL, benadryl, pepcid, IVF. Improved. Please email for further disposition as still in ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,MIL,,,,HPV vaccine as teenager,Hx of similar hive reaction after HPV vaccination,"['Pruritus', 'Tryptase', 'Urticaria']",2,PFIZER\BIONTECH,IM 1046902,PA,48.0,F,Flush,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PHM,Vitamin D OTC Preservision OTC Omega 3 6 9 OTC,Menstruating,High blood pressure Obesity,,Pennicillin Doxycycline Flagyl Aleve Progesterone (autoimmune) Cats Dust Mites Roaches,['Flushing'],1,MODERNA, 1046904,ME,59.0,F,"30 mins after injection arm pits on fire (lasted 12 hours) Chills and body aches started 4 hours after injection and lasted 2 days. NO fever. 2 days after injection developed rash on chest, back, arms and head. Rash lasted 2 days. NO hives. Rash was itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,OTH,"Vit D; Calcium, Fish oil, turmeric, Vit E, glucosamine, bee pollen Singulair, Cozaar, Symbicort",none,"asthma, high blood pressure",,"Kefzol, PCN, Toradol, Levaquin","['Axillary pain', 'Chills', 'Pain', 'Pruritus', 'Rash']",2,MODERNA,IM 1046905,CA,67.0,F,"Too dizzy to pen eyes, nauseous, diarrhea, headache, chills, sweating, duration about 6 hours, recovery within 10 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PUB,None,None,Mild depression,,None known,"['Chills', 'Diarrhoea', 'Dizziness', 'Headache', 'Hyperhidrosis', 'Nausea']",2,PFIZER\BIONTECH,IM 1046907,MO,65.0,F,"Chills, fever of 102, muscle aches, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,OTH,"levothyroxine, Calcium supplements and Vitamin D3",None,None,,Penicillin and Sulfa,"['Chills', 'Myalgia', 'Nausea', 'Pyrexia']",UNK,MODERNA,IM 1046908,MA,81.0,M,"Got the vaccine and did not notice anything until he looked in the mirror on 2/17/21, became pink, patch round 2-3"" in diameter, warm to touch. Still has the area, it has not grown and a few degrees warmer than the rest of the skin in the area.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/17/2021,10.0,OTH,"Finasteride, Atorvastatin, Hydrochlorothiazide, Levothyroxine, Tamsulosin, Oxybutynin, fish oil, Vitamin D3, B12, potassium gluetinate.",None.,"High blood pressure, thyroid, bladder issue.",,Sulfa,"['Erythema', 'Skin reaction', 'Skin warm']",1,MODERNA,IM 1046909,MD,69.0,M,"Patient was admitted for acute CVA, hyperglycemia, and mild thrombocytopenia. Patient was treated and discharged on appropriate medications",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/10/2021,02/13/2021,3.0,PVT,amlodipine,,Hypertension,,NKA,"['Cerebrovascular accident', 'Hyperglycaemia', 'Thrombocytopenia']",1,PFIZER\BIONTECH,IM 1046910,WA,66.0,M,"My first vaccination was given at Medical Center, on 1/27/21. Medication was Pfizer, Lot # EL3302. At time of scheduling I was told that I could get my second vaccination at facility, which was about 50 miles closer to my home. The scheduler verified that facility administered both Pfizer and Moderna vaccines. On 2/16, when I reported to facility for my second shot, I reminded the intake person and the one who escorted me to the vaccination station that I needed the Pfizer vaccine, and was told by both people that Pfizer was in the record and that I would receive that vaccine. The person who escorted me to the vaccination station brought the syringe to the vaccinator, who asked me my name and date of birth, administered the shot, and handed me the post-administration paperwork. While seated in the waiting area I read over my paperwork and reviewed my dosage record card and discovered, that I had been given the Moderna vaccine., against the CDC guidance and without prior notification to or authorization by me. I have subsequently experienced shortness of breath, an unusually high level of nasal congestion, nad a serious lack of energy. These symptoms began about 72 hours after the second vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/16/2021,0.0,PVT,"Glimepiride, metformin, Amlodipine, Candesartan, Zinc, Vitamin E, vitamin D, multivitamin",none,"high blood pressure, diabetes",flu-like symbols after receiving initial and booster shots of shingles vaccine,"Licorice, morphine","['Asthenia', 'Dyspnoea', 'Interchange of vaccine products', 'Nasal congestion']",2,MODERNA,IM 1046911,VA,70.0,M,"Possible MSG reaction, probably aggravated after vaccination. Had meal approx. 1 hour before vaccination. After vaccination (roughly 45 minutes), felt ""foggy"" feeling, akin to being drunk. After looking for possible links to vaccine, and given that the reaction seemed like a strong reaction previously attributed to MSG, searched the ingredients listed by the caterer and found that a side dish listed MSG. ~~ Drove home without incident. ""Foggy"" feeling dissipated after a few hours. No significant reaction to the vaccine itself except slightly sore arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PUB,"Methotrexate 12.5 QWK, metformin 500 b.i.d, Trulicity QWK, folic acid, vit. B-12","non-serological rheumatoid arthritis, controlled and non-symptomatic",rheumatoid arthritis; diabetes 2 drug controlled,,,"['Feeling abnormal', 'Feeling drunk', 'Pain in extremity']",2,MODERNA,IM 1046912,CA,73.0,F,pt stated about 2 hours after getting the 2nd dose of the covid vax that she felt like she was having an allergic reaction since her face started swelling. Pt contacted her PCP and is waiting on them to CB. She took two Benadryl and has noticed that some of the swelling has gone down. For now she will monitor the swelling and wait for the doctor to CB.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,OTH,"Lisinopril, Atorvastatin, Zoloft, Propranolol, Nexium, multivitamin, vitamin D, Zinc",no,"HBP, Chlorestoral, Shaking, Depression, Scleroderma,",,aspirin,"['Hypersensitivity', 'Swelling face']",2,PFIZER\BIONTECH,IM 1046913,CA,78.0,F,"moderna COVID-19 Vaccine EUA rash occured on Feb. 18th on neck sides of face forhead very red very itchy also about a couple of inches on the front of my chest directly under my neck I had a similar reaction after a shingtrex second dose shot which was given January 19th 2021ad a teledoc appt. on Feb. 19th was prescribed to take an antihistamine(claritan or zyrtex and use a cream, triamcinolone acetate for the rash and if needed a benedryl tabblet at bed time but only if necessary due to severe itching the cream gave enough relief in that regard so no benedryl was necessary I also had a very light head ache and a bit of stiffness in my neck during this time also, although I don't know if this is relevant to the vaccine I am a carrier of Kennedy disease and occasionally have vessiculations I have not seen any doctor about this but I hbit of that the day after my shotad a slight",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/15/2021,02/18/2021,3.0,UNK,"benezaperil/hctz, all nuts and legumes","none just a note I had a shingtrex vaccination 2nd dose on Jan 19, 2921 and had a similar reaction",high blood pressure,,"latex, dilaudid, cipro, proponolol, ativan, hydromorphone hcl unspecified, peanut oil, all nuts and peanuts","['Headache', 'Musculoskeletal stiffness', 'Rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,SYR 1046915,IA,66.0,F,"Resident received the 2nd dose of the Covid vaccine approximately around 1105 by pharmacy through the pharmacy LTC partnership vaccination program. Resident had no adverse effects until around 8:00 pm she began complaining of body aches, and chills, Tylenol was given at this time. Around 9:30pm resident was sleeping in bed. Around 12:00 am the CNA called nurse into room to assess resident as the resident stated she did not feel good. Temperature at that time was 102.2, and vomiting. RN came to assess @ 1220 am She was noted to be vomiting, diaphoretic, pale and having trouble breathing. Temp was 97.3 after vomting, Pulse 53, Resp 20, o2 sats were 40-45%, unable to obtain Blood pressure, Applied 5 L of oxygen at this time and had LPN call 911 immediately. Resident was repsonsive and able to follow staff members instructions but was only answering yes or no simple questions at the time time of assessment. Paramedics arrived at 0040 and resident was sent to Hospital. @ 0130 ER nurse called to nursing facility to notify resident had coded in the ER and passed away @ 0110.",Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,SEN,"Humalog Insulin Sliding scale 4 times daily, Acidophilus Probiotic Blend CP 1 capsule 3 times daily with meals, Amiodarone 200mg 1 tab twice daily, Aspirin 81mg 1 tab once daily, Atorvastatin 40mg 1 tab at bedtime, Bumetanide 0.5mg 1/2 tab",,"Above the knee amputation of left lower extremity, Coronar Artery Disease, Clotted Dialysis access, Previous COVID-19 Virus Infection 11/2/20. Diabetes, Dialysis patient, End Stage Renal Disease, Gastric Bypass status for obesity, Hypertension, Non healing wound of amputation stump, Polyneuropathy, Pneumonia secondary to COVID infection, Atrial Fibrillation, Hx of stroke,",,"Tramadol (vomiting, nausea), Tape (Rash, Itching), Bee stings (anaphylactic reaction), Betadine (rash, Itching), Wasps (anaphylactic reaction), Clonidine( vomiting), Isosorbide (vomiting)","['Blood pressure immeasurable', 'Body temperature increased', 'Cardio-respiratory arrest', 'Chills', 'Death', 'Dyspnoea', 'Feeling abnormal', 'Hyperhidrosis', 'Pain', 'Pallor', 'Vomiting']",2,PFIZER\BIONTECH,IM 1046916,WA,66.0,F,"Pt went to unconscious; reported SOB and then slowly went unresponsive. code blue called immediately, patient still with BP WNL, oxygenating fine, had a pulse. gag reflex+ when oral airway placed. Taken to ED w/ team. Epi IM given, Ativan given, Benadryl given, glucose given. Pt became awake and alert, talking, observed at ED, then discharged to home at 1226",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PVT,,,,,,"['Dyspnoea', 'Loss of consciousness', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 1046917,NY,17.0,F,"MEDICATION ERROR. PATIENT AGE 16, UNDER AGE FOR EUA.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,OTH,NONE REPORTED,NONE REPORTED,NONE REPORTED,,NONE REPORTED,['Product administered to patient of inappropriate age'],2,MODERNA,IM 1046918,WI,29.0,F,"Client arrived for second dose of COVID vaccine and disclosed that she had a reaction to the first dose. She described having ""chest pain"" two days later. She denied of having experienced before and denied any cardiac history in the past. She described the chest pain as pressure and she did ""feel a lump in her throat."" This occurred after carrying groceries up stairs. She denied doing anything out of the ordinary. Denied difficulty breathing, swelling, or other symptoms. Client did not seek medical attention at the time. Second dose was not administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/30/2021,2.0,PUB,Synthroid,,"Thyroid condition, not specified",,None,"['Chest discomfort', 'Chest pain', 'Sensation of foreign body']",1,PFIZER\BIONTECH,IM 1046919,AK,60.0,F,"pain at injection starting overnight. It was worse with the first vaccine. Pain in right lower mandible on both vaccines started the day after the vaccine. This pain was 5 on a scale of 10. Lymphedema after 2nd vaccine only on the same side as the vaccine was given so only in the right axillary LN, began the 2nd day and lasted about 4 days. Tired more after 2nd vaccine. Continued to work, no time off taken.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PVT,"Calcium, magnesium, CoQ 10, Vitamin D, Red yeast rice, glucosamine, probiotics, Vitamin K1, Restasis eye drops, Tretonin face cream, metronidazole face cream","Right lower mandibular pain after first COVID vaccine as well. I get this pain occasionally if getting a cold, sinusitis, or allergies or unknown reasons.",arthritis for age. Intermittent asthma/bronchitis flair ups but only after colds usually. None in last year. Also no colds for a year due to minimal exposure.,,No,"['Fatigue', 'Injection site pain', 'Lymphoedema', 'Pain in jaw']",2,MODERNA,IM 1046920,MA,54.0,F,"Chills, arm pain (@ injection site), tiredness, nausea during the first few days after vaccination then resolved but today 2/22/21 all symptoms returned-except arm pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/16/2021,02/22/2021,6.0,UNK,,,,,,"['Chills', 'Fatigue', 'Injection site pain', 'Nausea']",UNK,MODERNA, 1046921,PA,48.0,F,Arm Pain beginning 6 1/2 hours after injection and lasting 2 days. Tender to touch 3+ days. No response to Tylenol.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PHM,Vitamin D OTC Preservision OTC Omega 3 6 9 OTC,Menstruation,Obesity High Blood Pressure,,Penicillin Doxycycline Flagyl Aleve Progesterone (autoimmune),"['Pain in extremity', 'Tenderness']",1,MODERNA, 1046922,TX,51.0,F,"fever,diarrhea,body aches,rash and fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/02/2021,1.0,PVT,UNK,UNK,UNK,,UNK,"['Diarrhoea', 'Fatigue', 'Pain', 'Pyrexia', 'Rash']",2,MODERNA,IM 1046923,,57.0,F,"Head feeling heavy, dizzy when turning head from side to side. Evaluated by EMS. BP 142/80, HR 82, O2 97%. 1:45 pm feeling better. 1:51pm feeling better, BP 129/74, HR 70 - discharged home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,,,,,,"['Dizziness postural', 'Head discomfort']",2,MODERNA,IM 1046924,NJ,82.0,F,"Very itchy, hot , very red area on arm about two inches below injection site down to elbow crease (about 3 to4 by 6 to 7 inches) beginning day after injection. Applied OTC 1% cortisone cream 4 times daily. On Feb 22 seems to be slightly better at least less itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,OTH,"metoprolol, Thyroxine, warfarin, AReds2, multivitamin. calcium",,"AFib, hypothyroidism, arthritis, macular degeneration",had small itchy area after first Moderns vaccine,penicillin,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",2,MODERNA,SYR 1046925,CO,42.0,F,"2nd report. on 2/9/21, she developed a painful swollen gland in the left side of her neck, with no other associated signs of illness. This resolved by 2/15/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/09/2021,7.0,WRK,,,,Moderna COVID,,"['Lymphadenopathy', 'Neck pain']",1,MODERNA,IM 1046926,IL,55.0,F,"Since the 1st shot, I have experienced a sudden onset and increasingly worsening pain in my left wrist. The immediate reaction at the time of the shot was strong tingling in my left arm. The next day, I felt sore all over my body, as well as cold/flu like symptoms for 2 days. But the wrist pain has been getting worse, and consistent. I broke that wrist 10 yrs ago, and may have some slight work related carpel tunnel. With that in mind, I can say that the current issues and pain I?m dealing with have been acute and severe since I received the first dose of the vaccine. I just received the second dose 3 days ago, and still my wrist is hurting. I am careful to make sure I don?t put too much weight on it, and often wear a wrist brace. I am currently waiting to see my primary care doctor to seek medical attention.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,SCH,"Acetazolamide 500MG ER (1 pill) Centrum minis Women 50+ (1 pill) Vitamin D3 2,000 IU (1 pill) Vitamin C 1,000mg (1 pill) Cranberry Extract 500mg (1 pill) Esomeprazole Magnesuim 20mg (1 pill)",None,IIH,,Benadryl Neosporin,"['Arthralgia', 'Immediate post-injection reaction', 'Influenza', 'Nasopharyngitis', 'Pain', 'Paraesthesia']",2,PFIZER\BIONTECH,SYR 1046927,,52.0,F,"Patient received the Covid-19 vaccine. She reports symptoms of Other: pt reports having neck pain up her neck into lt ear and the ear felt plugged, post COVID Vaccine dose 2, pt states having the same occurance. Pt agreed to 30min wait post vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,OTH,,none,,,IVP c ontrast,"['Ear discomfort', 'Ear pain', 'Neck pain']",2,MODERNA,IM 1046928,AR,83.0,F,"difficulty breathing, tightness in chest, dizziness, weakness, headache, rash-immediately after vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,UNK,,,lung cancer,,"sulfur, penicillin","['Asthenia', 'Chest discomfort', 'Dizziness', 'Dyspnoea', 'Headache', 'Immediate post-injection reaction', 'Rash']",1,MODERNA,IM 1046929,CA,75.0,F,"Nausea, vomiting, Fatigue, headache, muscle pain, chills , lack of appetite -drank only water until 2-6. excessive sleeping.(day and a half). No treatment- After vomiting about 36 hours after vaccine, felt better. No fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/05/2021,1.0,PVT,"Meloxicam, multi vitamin, glucosamine/chondroitin, azelastine, caltrate",None,Arthritis,,Pollen from plants,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Hypersomnia', 'Myalgia', 'Nausea', 'Vomiting']",1,MODERNA,IM 1046930,IL,37.0,F,fatigue weakness headaches hot flashes brain fog nauseous upset stomach,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/18/2021,1.0,WRK,inhaler as needed for asthma pantoprazole,,,,,"['Abdominal discomfort', 'Asthenia', 'Fatigue', 'Feeling abnormal', 'Headache', 'Hot flush', 'Nausea']",2,MODERNA,SYR 1046931,NC,72.0,F,Bright red patch at site of injection. One week later and arm still red and itching. Started using hydrocortisone cream and taking benedryl.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/15/2021,1.0,PHM,Vitamin D 5000iu,None,"Rheumatoid arthritis , microscopic colitis",,"Medications: penicillin, Arava, methotrexate , humira, sulfa drugs,","['Injection site erythema', 'Pruritus']",1,MODERNA,IM 1046932,MA,79.0,F,"On 2/13/21 she woke up and had a lump on her arm, round pink area around the lump 2-3"" in diameter, warm to touch. This then spread down her arm 2-3"". Did not have pain or soreness. She went to the ER and the doctor looked at it, and she told her that she did not know if it was a reaction to the vaccine or if the are was not cleaned up right. She then put her on an antibiotic and told her to see her doctor. She FU with the PA and he didn't give her any further instructions. The area has residual pinkness, warm to touch, warmer than the rest of the arm, but not much.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/13/2021,6.0,OTH,"Hydrochlorothiazide, Lisinopril.",None.,High blood pressure.,,Sulfa,"['Limb mass', 'Skin discolouration', 'Skin warm']",1,MODERNA,IM 1046933,PA,44.0,F,"Moderna COVID-19 Vaccine EUA About 18 hours after vaccine, started feeling chills and tireness. Continued through the day, getting worse as the day went on. Skin was crawling, felt weak and unable to do anything. Feeling better today, 2/21/21, but still a little nauseous and not quite myself.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PVT,"Ocella, Premarin, Omeprazole, Fantidine, Fish Oil, Bentyl, Calcium, Iron, Vitamin B & C",none,"acid reflux, IBS",,none,"['Asthenia', 'Chills', 'Fatigue', 'Feeling abnormal', 'Formication', 'Nausea']",2,MODERNA,SYR 1046934,UT,73.0,F,Initial 2 days of flu like symptoms but today is day 4 post vaccine and the patient is reporting continued headaches into today.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/22/2021,3.0,WRK,,,,,"morphine, clarithromycin, lortab, prednison, warfarin","['Headache', 'Influenza like illness']",2,MODERNA,IM 1046935,NM,68.0,F,"Approximately 2 days after the second injection, a large red flat rash (about 3"" x 3"") began to form on my R arm, around and beneath the injection site. Shortly after that, an extremely intense itching set in and lasted for 48 hours or so. The itching was extreme, and not helped by either Benadryl or topical hydrocortosone cream. The itching was worse than that produced by exposure to poison ivy. I experienced a similar reaction to the second Shingrix (shingles) injection, although the red rash that occurred after this injection was a bit raised and welt-like, in places. Itching was also extreme, and very difficult to tolerate. It, too, lasted about 48-72 hours. Interestingly, I did NOT have this type of reaction to my annual flu shot this year, nor have I ever had such a reaction before. I'd like to know what inactive ingredients are common to both the Shingrix and Pfizer vaccines, as I suspect that something like that is the culprit. Also seeking advice about what to do when boosters are recommended, if they are, for Covid-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/11/2021,2.0,PUB,Levoxyl Lorazepam Gabapentin Prazosin Ezetimibe Aspirin 81mg,None,Heart disease,"As described above, I had an almost identical reaction to the second dose of the Shingrix vaccine approx. 1 1/2 years ago. Had",Codeine Penicillin,"['Injection site pruritus', 'Injection site rash']",2,PFIZER\BIONTECH,IM 1046936,CA,76.0,F,Low grade fever Aching joints Mild head ache 1 day EXHAUSTION 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PVT,None,None,None,,Codine,"['Arthralgia', 'Fatigue', 'Headache', 'Pyrexia']",2,MODERNA,IM 1046937,MO,65.0,F,"I had headache, chills, sore throat, shortness of breath, fatigue, anxiety & couldn't sleep well for 2 nights. the next day I was mostly better, but on day 3 on got sick again with sore throat & fatigue. I am very concerned about taking the next dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,OTH,"Lexapro, Estradial & Armour Thyroid",,,,Seafood,"['Anxiety', 'Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Malaise', 'Oropharyngeal pain', 'Poor quality sleep']",UNK,MODERNA, 1046938,,53.0,F,Sinus tachycardia to the point that she is now out of work,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/25/2021,01/25/2021,0.0,UNK,,,,,,"['Impaired work ability', 'Sinus tachycardia']",1,MODERNA,IM 1046939,CA,37.0,M,Body aches 24 hours after second dose - resolved 48 hours after onset. fever of 102F 40 hours after second dose - down to 100F 45 hours after second dose - fever fluctuated between 99F and 102F until 64 hours after second dose. all symptoms resolved 72 hours after second dose.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/26/2021,1.0,PVT,"Tramadol, allopurinol, multi-vitamin, fish oil, Vit D, Vit C",,"Lower Back Pain, Gout",,NKDA,"['Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1046940,CA,52.0,F,"Within 15 minutes of receiving the vaccine, the patient described feeling prickly sensation and pruritus around mouth and labial region. She also noted within 20 minutes of receiving the vaccine that her tongue felt larger than normal. 50 mg Diphenydramine (BENADRYL) was administered within 5 minutes of symptom report, patient noted she was feeling less, itchy, her tongue still felt larger than normal. Patient was able to swallow the two caplets without any difficulty and a visual exam of her mouth, tongue and pharynx at time of symptom report and before leaving the clinic was normal with no enlargement noticed. ER precautions reviewed and the patient was encouraged to call clinic immediately for any concerns, worsening or non-improvement Patient was advised to take Diphenhydramine (BENADRYL) 50 mg in about 5-6 hours. The patient was called at home around 8 PM , she still felt some residual symptoms and agreed to take Diphenhydramine 50 mg (second dose). She is also advised to take Allegra (Fexofenadrine) 180 mg daily for 14 days. Patient referred to an allergist for advice on whether or not to receive Moderna #2 due four weeks follwoing initial dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PUB,None,None,None,,"PCN, Baclofen","['Oral pruritus', 'Paraesthesia', 'Paraesthesia oral', 'Pruritus genital']",1,MODERNA,IM 1046941,MD,75.0,F,Patient was admitted due to confusion and poor oral intake most likely due to esophageal spasm. Pt remains hospitalized at this time,Not Reported,,Not Reported,Yes,9.0,Not Reported,N,02/12/2021,02/13/2021,1.0,PVT,"Magnesium, vit D, divalproex, isosorbide, levothyroxine, metoprolol, nitroglycerin, pantoprazole, pravastatin, Xarelto, rizatriptan, sertraline, sucralfate, tramadol, ursodiol",,"a fib, CVD, GERD, HTN, hyperlipidemia, hypothyroidism, neurofibromatosis",,"colesevelam, erythromycin base, fenofibrate, paroxetine, rofecoxib, topiramate","['Confusional state', 'Hypophagia', 'Oesophageal spasm']",1,PFIZER\BIONTECH,IM 1046942,NY,16.0,F,"MEDICATION ERROR, VACCINE GIVEN TO PATIENT UNDER THE AGE OF THE EUA,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,OTH,,,,,,['Product administered to patient of inappropriate age'],2,MODERNA,IM 1046943,MA,25.0,M,loss of smell occurring 3-4 days after first vaccination. loss of smell lasting more than 5 days and fully recovered within one week,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/29/2021,3.0,WRK,,,,,,"['Anosmia', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 1046944,NH,73.0,F,"Vaccine at 945 am Friday Calves of both legs cramped rock hard at 10 pm Friday and remained so for 18 hours. Had to use heating pad and massage to help feet relax from en pointe position so I could walk to the bathroom. Legs were sore after 18 hours but not cramped . Also massive headache made my eyes light sensitive all day Saturday and Sunday until about 9PM. Extreme exhaustion. Recovering today, Monday. Still tired an s slight residual headache at times but not bad enough for painkiller.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,OTH,"levothyroxine, desvenlaflaxine, atorrastatin,",none,asthma,,codine,"['Fatigue', 'Headache', 'Induration', 'Muscle spasms', 'Pain in extremity', 'Photophobia']",2,PFIZER\BIONTECH, 1046945,MD,77.0,M,The client was mistakenly vaccinated prior to the due date for his second Moderna dose. The second dose was given only 18 days after the first dose.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/16/2021,0.0,PUB,,,,,,['Inappropriate schedule of product administration'],UNK,MODERNA,IM 1046946,,47.0,F,C/o itching and redness and slight swelling in hands. States this happens when receiving antibiotics. Assessed by EMS-no treatment. Discharged home at 1:36pm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,,,,,,"['Erythema', 'Peripheral swelling', 'Pruritus']",2,MODERNA,IM 1046947,PA,47.0,F,"Received second dose of Moderna vaccine. While in the observation area, I started to feel flushed and like something was not right and reported to the lead onsite RN. My BP was 235/131, pulse 140, Pulse Ox 99%, and was having difficulty swallowing and breathing. A code was called. I was given EpiPen with some relief but not total. The emergency team administered Methylprednisone 60mg IV and 911 transported me to the ED where I remained for observation for about 5 hours with no further treatment required.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,Trintellix,None,,,"Penicillin, Clindamycin--Hives Bactrim--Serum Sickness","['Dysphagia', 'Dyspnoea', 'Feeling abnormal', 'Heart rate increased', 'Hot flush', 'Hypertension']",2,MODERNA,IM 1046948,FL,24.0,M,Patient received his vaccination. Remained seated in the waiting area after receiving the vaccination for monitoring. Patient reportedly became light headed a few minutes later after receiving the vaccine and was helped to the ground to lay down. Patient remained conscious but reported feeling a little cold and light headed. EMS arrived and helped the patient up to his feet.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PHM,No known medications,No known illnesses,No known chronic conditions,,No known allergies,"['Dizziness', 'Feeling cold']",1,MODERNA,IM 1046949,OH,33.0,F,"Patient c/o feeling lightheaded 5 minutes after administration. BP was normal. Gave cold water. Developed itchy red rash across chest ~8 minutes after administration. This began to fade ~15 minutes after administration, but patient then complained that tongue felt funny & began clearing throat. After consulting with our NP, Epipen was administered (0.3mg), & 911 called. Transported via ambulance ED. Pt reported tongue feeling better after Epipen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,OTH,Unknown,None stated,None known,,Amoxicillin,"['Dizziness', 'Paraesthesia oral', 'Rash', 'Rash erythematous', 'Rash pruritic', 'Throat clearing']",1,PFIZER\BIONTECH,IM 1046950,LA,68.0,F,"No energy, tired, redness @injection site, bruised 3 days later @ injection site. No appetite, just wanted to sleep, slight temp Lasted 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,PVT,None,None,None,,None,"['Asthenia', 'Body temperature increased', 'Decreased appetite', 'Fatigue', 'Injection site bruising', 'Injection site erythema']",1,MODERNA,IM 1046951,AZ,48.0,F,Itchy left leg and neck. No welts.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/20/2021,0.0,PUB,none,none,asthma with allergies,,penecillin,['Pruritus'],1,MODERNA,IM 1046952,UT,80.0,F,"Redness, swelling and itching that came on 9 days after she was given the shot. We read on her information sheet that we needed to contact someone if this happened after 24 hours so she is concerned.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/20/2021,9.0,OTH,Losartan,,,,,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA,IM 1046953,MT,50.0,F,"Chills, Body Aches, Nausea, & Headache",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/17/2021,1.0,PVT,,,,,,"['Chills', 'Headache', 'Nausea', 'Pain']",2,MODERNA,IM 1046955,AL,44.0,F,About an hour after my vaccine I felt like my tongue had been burned with hot liquid. It stayed that way for several hours. 2 days later my arm felt like someone was hitting it over and over with a needle. I had numbing pain in my shoulder and back. I felt nauseated. It has been over a week and I still have pain at the injection site and have body aches. I am unsure who to contact and am not sure what I should do.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,OTH,Lexapro 20 mg,None,NOne,,none,"['Arthralgia', 'Back pain', 'Hypoaesthesia', 'Injection site pain', 'Limb discomfort', 'Nausea', 'Pain', 'Tongue discomfort']",1,PFIZER\BIONTECH,SYR 1046956,WA,31.0,U,Patient had her first covid vaccine on Wed 1/6. She injected her orencia that following Sat and reports getting a migraine. Patient slept for 16 hours and woke up feeling better. Her 2nd covid vaccine was Friday 2/15. she injected orencia on Sat and reports a migraine once again. She medicated with excedrin and was feeling slightly better by Sunday. Patient has a hx of migraines with her lupus. She is doing well now and no issues with migraines or her RA.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/09/2021,3.0,PVT,orenica,,"Rheumatoid arthritis, lupus",,,['Migraine'],1,MODERNA,IM 1046957,IL,83.0,F,Redness of arm a week after the injection. Dr reported that it did not appear to be a reaction to the shot but that it looked like a skin infection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,PHM,,,,,,"['Erythema', 'Skin infection']",1,MODERNA, 1046958,IL,66.0,F,Developed itchy hives at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/08/2021,3.0,PVT,,,,,tape,"['Injection site pruritus', 'Injection site urticaria']",1,MODERNA,IM 1046959,CO,70.0,F,"A 70 y/o female who presented to Urgent Care for arm pain (left arm was swollen, itch and redness after getting COVID vaccine 8 days ago). At the initial visit, the provider thought the patient had cellulitis. Therefore a course of 7 days of Keflex was given. Patient finished her antibiotic and those symptoms still persisted. She came back to her primary care with still mild erythema and warmth of the left lateral arm. At this time, her doctor diagnosed her with a local reaction to the COVID vaccine and the patient was sent home with triamcinolone which she had.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/29/2021,02/06/2021,8.0,PVT,,,,,Quinacrine (panic attacks) Venom -wasp (swelling) Penicillin (Rash),"['Erythema', 'Pain in extremity', 'Pruritus', 'Swelling']",1,MODERNA,IM 1046960,MD,89.0,F,"Patient was admitted for lower extremity pain, swelling, and development of a blood blister. Hematoma was drained and pt was found stable for discharge",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/02/2021,02/13/2021,11.0,PVT,,,"Arthritis, afib, CAD, COPD, GERD, HTN, HLD, hypothyroidism, PVD",,"iodinated contrast (itching), clindamycin (itching)","['Blood blister', 'Haematoma evacuation', 'Pain in extremity', 'Swelling']",1,MODERNA,IM 1046961,MT,35.0,F,Nausea & Body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/17/2021,1.0,PVT,,,,,,"['Nausea', 'Pain']",2,MODERNA,IM 1046962,FL,71.0,F,"Severe headache 24', aches and tiredness. Symptoms 1/2 as bad next 24 '.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,PUB,"Wellbutrin, acyclovir, Lipitor, estradial, levothyroxine, co10, fish oil, multi vitamin,msm/glucosamine /chrondrotin,",None,"Herpes simplex, high cholesterol, hypothyroidism",,Anaphylactic allergy to wheat. Zantac Dust Cannot tolerate excess B vitamins,"['Fatigue', 'Headache', 'Pain']",1,MODERNA,SC 1046963,MO,72.0,F,"We arrived on 02/10/2021 to give second doses to residents. Upon arrival we were told several had contracted COVID-19 after their first immunization. Upon reviewing their records, it had been greater than 14 days of recovery, per CDC recommendations, they should have received their second doses. The director of nursing and the facility physician however told us we were not to vaccinate the residents until 30 days from their last negative test. After discussing guidelines and recommendations they would not change their minds. This is 1 of 18 patients that did not receive their second dose in the 6-week window at this facility.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/13/2021,01/01/2021,,PHM,,,,,,['Inappropriate schedule of product administration'],1,MODERNA,IM 1046964,CA,70.0,F,"I have a lot of pain on my left side, where I got the vaccine, and it radiates from my neck to my shoulder and especially in my shoulder blade.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,PHM,"Atenolol and Pravastatin (the night before) Lisinopril, Omeprazole, and Low-dose aspirin (morning of)",None,"High blood pressure (not for my entire life) I use an inhaler depending on the situation, i.e., during the wildfires and strenuous exercise. I did not use it the day I got the vaccine.",,Cats,"['Arthralgia', 'Injected limb mobility decreased', 'Pain']",1,MODERNA,IM 1046965,TX,58.0,F,"my arm is swollen at the injection site and is sore and tender to the touch and hurts really bad. its sore from the shoulder from the shoulder to above the elbow. My hands are swelling, my right had especially.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/22/2021,1.0,PHM,choosing not to list,No,High blood pressure high cholesterol Hypothyroidism open ankled glaucoma asthma fibromyalgia arthritis cervical and low back strain carpal tunnel minimal white matter of the brain morbid obesity tendonitis of the hips,,endomethisine Haldol,"['Injection site pain', 'Injection site swelling', 'Peripheral swelling']",1,MODERNA,SYR 1046966,,35.0,F,Numbness in right forearm. Evaluated by EMS. 1:30 pm numbness resolving without treatment and discharged home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,,,,,,['Hypoaesthesia'],2,MODERNA,IM 1046967,CO,36.0,F,My arm started to really hurt on Saturday (20th) and I noticed a red bulls-eye rash on my arm around the injection site today (22nd).,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,02/20/2021,10.0,OTH,None,None,None,,"Many environmental allergies (trees, pollen, animals, dust, etc)","['Injection site reaction', 'Pain in extremity', 'Rash erythematous']",1,MODERNA,SYR 1046968,IA,74.0,F,"1.Swelling, redness, pain , rash about size of silver dollar. Did not start to appear until about the 7-8 day. Reaction continued to get worse until day 12. It is now day 15 and much improved but still present. 2. Noticed having some difficulty swallowing on the 3-4 day. Did not have problems with swallowing foods, only when trying to swallow small amounts of liquid , such as accumulated saliva. I had to consciously engage muscles to gulp or get more liquid to get it down. The problem is improved now at day 15.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/07/2021,02/09/2021,2.0,PVT,"Eliquis, olmesartan, HCTZ",none,"Hi BP, Obesity",,None,"['Dysphagia', 'Erythema', 'Pain', 'Rash', 'Swelling']",1,PFIZER\BIONTECH,IM 1046969,MO,70.0,F,Left side face and hand numbness lasting through out the day on 2/7/2021 starting around 1:00 pm. Resolved by the following day. No treatment sought. Did not lose motor function and no reports of facial drooping.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/07/2021,2.0,PUB,"Levothyroxine, Omeprozole, Metoprolol, Valsartin, Wellbutrin, Amitizia, Lopinol, Alopurinol, Hydroxine, Biotin, Multivitamin, Keflex",Recovering from a Urinary Tract Infection,"Irrital Bowel Syndrome, Hypertension, Hypothyroid, Gout, Anxiety",,"PCN, Statins Tramadol",['Hypoaesthesia'],1,MODERNA,IM 1046970,WY,81.0,F,"Nausea, vomiting, diarrhea, dizziness, fainting",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/19/2021,02/20/2021,1.0,OTH,BP medication,,History of lung cancer- remission Hypertension COPD,,NKA,"['Diarrhoea', 'Dizziness', 'Nausea', 'Syncope', 'Vomiting']",2,MODERNA,IM 1046971,MO,57.0,F,"We arrived on 02/10/2021 to give second doses to residents. Upon arrival we were told several had contracted COVID-19 after their first immunization. Upon reviewing their records, it had been greater than 14 days of recovery, per agency recommendations, they should have received their second doses. The director of nursing and the facility physician however told us we were not to vaccinate the residents until 30 days from their last negative test. After discussing guidelines and recommendations they would not change their minds. This is 1 of 18 patients that did not receive their second dose in the 6-week window at this facility.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/13/2021,01/01/2021,,PHM,,,,,,['Incomplete course of vaccination'],1,MODERNA,IM 1046972,NM,48.0,F,"02/15/21 About 7-715pm injection site red with small raise circle around site (maybe dime to nickle size) developing. Site stayed red for ~48hrs. Arm was sore, but nothing too bad. At hour 35 developed fatigue. Redness started to fade. Not much activity around site until early morning of 02/22/21 when site started to redden again and rash began to develop. Site began getting itchy and noticeably hot at 9am. At 1245pm surrounding skin and other arm surface temps were ~85-86 degrees but area around injection site and on rash was 95.6 to 96.8 degrees. The reaction is roughly 2/25"" (top to bottom) x 2/5"" (side to side) at 1:28pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/22/2021,7.0,PHM,"daily baby aspirin (am) propanolol (80mg/once day, pm) Calcium/mag/zinc (Whole Foods 365 brand, 2 tablets am) Krill oil (Vital Choice brand, one 1000 mg softgel, am)","High BP (diagnosed Jan, 2021) BMI >30 exercise and allergy induced asthma",,,no,"['Fatigue', 'Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,SYR 1046973,KY,45.0,F,"fatigue, aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/22/2021,1.0,PVT,iron supplement calcium + vitamin D supplement probiotic,none,none,"mild nausea after 1st COVID-19 vaccine, Moderna, 12-24-2020, age 44",none,"['Fatigue', 'Pain']",2,MODERNA,IM 1046974,NC,65.0,M,"Moderna COVID?19 Vaccine EUA 3"" to 4"" rash on upper arm appeared eight days after injection (1st shot)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PHM,"Amlodipine 10mg, Vit B Complex, Vit. D3, Turmeric 1000 mg",None,None,,None,['Rash'],1,MODERNA,IM 1046975,MO,87.0,F,"We arrived on 02/10/2021 to give second doses to residents. Upon arrival we were told several had contracted COVID-19 after their first immunization. Upon reviewing their records, it had been greater than 14 days of recovery, per agency recommendations, they should have received their second doses. The director of nursing and the facility physician however told us we were not to vaccinate the residents until 30 days from their last negative test. After discussing guidelines and recommendations they would not change their minds. This is 1 of 18 patients that did not receive their second dose in the 6-week window at this facility.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/13/2021,01/01/2021,,PHM,,,,,,['Inappropriate schedule of product administration'],1,MODERNA,IM 1046976,MT,61.0,F,"Rash, Fever. Chills, Headache, & Nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PVT,,,,,,"['Chills', 'Headache', 'Nausea', 'Pyrexia', 'Rash']",2,MODERNA,IM 1046977,CA,68.0,F,"Red, itchy rash and swelling developed near the injection site a few days after vaccine. The itching and redness subsided after approximately a week. However, now at four weeks since first dose, the area is still slightly discolored with dry skin.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/22/2021,01/28/2021,6.0,UNK,,,,,,"['Dry skin', 'Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Skin discolouration']",1,MODERNA, 1046978,VA,81.0,F,"COVID 19 Pfizer - 2nd dose, 2/16/2021 Lot number - EL9261 - About 48 hours later, I got this pain breastbone. I couldn't turn over to the left or right when down because of the pain. It was not shortness of breath. It was pretty bad. This pain lasted about 3 weeks. Soreness is my arm appeared the day of vaccination but that went away within 2 days. I also kept sneezing non stop, and my nose was runny this also started about 48 hours after vaccination. It is better but not completely gone yet. The sneezing is not constant, as of today but still there.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/28/2021,2.0,PVT,"Crestor 2.5 MG daily, Eplerenone 50 MG daily, Norvasc 5 MG daily, Daily - Vitamin C, Vitamin D, Magnesium, Alpha-lipoic acid",,"Neuropathy in right leg, Tinnitus left ear",,"Shellfish, Penicillin, Erythromycin, Bactrim, Contrast media (dye)","['Chest pain', 'Mobility decreased', 'Pain in extremity', 'Rhinorrhoea', 'Sneezing']",1,PFIZER\BIONTECH,SYR 1046979,OH,30.0,F,Extremely short of breath O2 was in low 90s and pulse was 130+ . Labs drawn and D-dimer was elevated . No active clot was found by the time I got to ER and seen . Due date June 11th 2021,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,PUB,Prenatal vitamin,None,None,,Penicillin,"['Computerised tomogram normal', 'Dyspnoea', 'Electrocardiogram normal', 'Fibrin D dimer increased', 'Heart rate increased', 'Oxygen saturation decreased']",2,MODERNA,IM 1046980,CA,17.0,F,No adverse reactions reported. Client did not meet the age 18 criteria per Moderna's manufacture guidance.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/22/2021,0.0,PUB,No,None,None,,No,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 1046981,NJ,73.0,F,Moderna COVID-19 Vaccine EUA Starting on third day after vaccination: pain and swelling in joints; pain and swelling of left jaw and face; difficulty opening mouth/eating due to pain and swelling of left jaw; intermittent earache in left ear Earlier more typical reactions first and second day after vaccine: pain and swelling at injection site; elevated temperature which responded to Tylenol; chills.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/19/2021,3.0,PUB,"Valsartan, Multivitamin, Glucosamine-Chondroitin, Calcium, Probiotic",None,"Asthma, high blood pressure, arthritis",,"Sensitivity to garlic, sucralose, latex, some antibiotics","['Arthralgia', 'Body temperature increased', 'Chills', 'Ear pain', 'Facial pain', 'Injection site pain', 'Injection site swelling', 'Joint swelling', 'Mastication disorder', 'Pain in jaw', 'Swelling face']",1,MODERNA,IM 1046982,MD,83.0,M,"Patient was admitted for pleuritic chest pain. It was determined during his hospitalization, that his pain was likely musculoskeletal in nature and was advised to follow up with PCP",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/22/2021,02/13/2021,22.0,PVT,"atorvastatin, clopidogrel, gabapentin, levothyroxine, losartan, MVI",,"HTN, HLD, diabetes, CVA",,sulfa abx (hives),"['Chest pain', 'Musculoskeletal pain', 'Pleuritic pain']",1,MODERNA,IM 1046983,AR,51.0,F,Enlarged lymph nodes on left and right side of armpits and both breasts. The left side enlargement was very visible to the naked eye and looked to be as large as a tennis ball. Both breasts where swollen and tender/sore. Right side enlargement of armpit as not as large (maybe the size of a golf ball).,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/14/2021,2.0,SCH,"Nitrofurantoin Mono/Mac, Ceterizine, Citalopram",UTI,,,"latex, aspirin","['Breast swelling', 'Breast tenderness', 'Lymphadenopathy']",2,PFIZER\BIONTECH,SYR 1046985,MT,41.0,F,"Fatigue, Fever, Body aches, & Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,PVT,,,,,,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",2,MODERNA,IM 1046986,,28.0,F,Mild-moderate dizziness for past 8 days,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/15/2021,2.0,UNK,Vitamins,,,,Amoxicillin,['Dizziness'],1,PFIZER\BIONTECH,IM 1046987,MO,85.0,F,"We arrived on 02/10/2021 to give second doses to residents. Upon arrival we were told several had contracted COVID-19 after their first immunization. Upon reviewing their records, it had been greater than 14 days of recovery, per agency recommendations, they should have received their second doses. The director of nursing and the facility physician however told us we were not to vaccinate the residents until 30 days from their last negative test. After discussing guidelines and recommendations they would not change their minds. This is 1 of 18 patients that did not receive their second dose in the 6-week window at this facility.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/13/2021,01/01/2021,,PHM,,,,,,['Inappropriate schedule of product administration'],UNK,MODERNA,IM 1046989,IN,75.0,M,"""panic attack"" as patient described prior to vaccine. Patient jumped with Vaccine injection. Took deep breathe, became diaphoretic. gasping respirations. Patient then began to cough, breathe rapidly, returned to normal rate depth and quality. Patient advised prior to the injection that these events would occur as described. Episode lasted 5 minutes. At 10:25 hr 88 rr 30 bp 171/91 10:35 hr 73 rr18 bp155/82 10:50 hr 70 rr12 bp 141/84 Monitored by paramedic for 30 minutes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PUB,NKA,None Reported,Not Reported,,None Reported,['Panic attack'],1,PFIZER\BIONTECH,IM 1046990,NY,78.0,M,"Chills, 101.5 fever, aches, headache, stiffness, unable to walk (joints wobbly)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,SCH,Rosuvastatin 5mg Biotin 5000mcg Gabapentin 200mg - 3X day. Vit D3 25mcg Allopurinol - 400mg Vit B12. - 1000mcg Low dose aspirin Levothyroxine. 75 mcg,,Sjogrin's,,Iodine dye,"['Chills', 'Gait inability', 'Headache', 'Joint instability', 'Musculoskeletal stiffness', 'Pain', 'Pyrexia']",UNK,MODERNA,SYR 1046991,IA,90.0,M,Developed shingles on 2/20/21,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/20/2021,16.0,PVT,advair inhaler atrovent inhaler fluticasone omeprazole tamsulosin ventolin inhaler,COPD,Copd BPH,,NOne,['Herpes zoster'],1,MODERNA,IM 1046992,OH,79.0,M,Client has developed a whole body rash/ hives (ankles to face) starting 2-18-202He still has the hives (2-22-2021),Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/18/2021,9.0,PUB,Losartan Co-Reg Allopurinol Vit D 3 ASA- 81mg Lipitor every other day,no,Hypercholesterolemia HX open heart surgery pacemaker,,None known,"['Rash', 'Urticaria']",2,MODERNA,IM 1046993,CA,23.0,M,Reported loss of taste and smell within 24 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/12/2021,01/13/2021,1.0,UNK,,,,,,"['Ageusia', 'Anosmia']",1,MODERNA,IM 1046994,CT,73.0,M,"neutropenia of unclear origin or significance noted on labs 2/11/21 WBC 2.2, NT count 35%, other cell lines within normal limits last labs done was > 1 year prior and had normal WBC count 6-7 repeat labs 2/22/21 WBC 1.9, NT 25%, ANC 570 Asymptomatic, no infections, no fevers",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/11/2021,8.0,PVT,"Amlodopine, Lisinopril, Trazodone, Naltrexone",none,"- HTN - HLD - Hx of Melanoma removed back and shoulder, also NMSC - Essential tremor s/p shrapnel wound in service - ETOH dependence, quit beginning of 2020 - Hx of back injury 1972/ruptured disk",,,"['Basophil percentage', 'Blood folate normal', 'Blood smear test', 'Blood test', 'Eosinophil percentage', 'Flow cytometry', 'HIV test negative', 'Haematocrit decreased', 'Haemoglobin decreased', 'Hepatitis C test negative', 'Leukocytosis', 'Lymphocyte count', 'Lymphocyte percentage increased', 'Mean cell haemoglobin concentration', 'Mean cell volume increased', 'Mean platelet volume normal', 'Methylmalonic aciduria', 'Monocyte percentage increased', 'Neutrophil count decreased', 'Neutrophil percentage decreased', 'Nucleated red cells', 'Platelet count normal', 'Red blood cell count decreased', 'Red cell distribution width normal', 'White blood cell count decreased']",UNK,PFIZER\BIONTECH,SC 1046995,NE,66.0,M,"He states that he began urinating every 2 hours at approximately 6 p.m. the day he received his second vaccine (approximately 4 hours after his vaccine) and this lasted until 8:00 a.m. the following morning (14 hours). He had no other urinary complaints to suggest an infection. He also had 3 episodes of diarrhea, fatigue, and joint pain following his second dose of vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PVT,"Benadryl 25 mg by mouth, 1 to 2 tablets as needed at bedtime",,PTSD related to military service Macular degeneration,,No known allergies,"['Arthralgia', 'Diarrhoea', 'Fatigue', 'Pollakiuria']",2,MODERNA,IM 1046996,MT,26.0,F,"Fever, Nausea, Injection site swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,PVT,,,,,,"['Injection site swelling', 'Nausea', 'Pyrexia']",2,MODERNA,IM 1046997,CA,41.0,F,"Large red rash approximately 5 inches in diameter surrounding injection site. Colored red to purple. Hot to the touch. Muscle very hard and swollen. Itchy rash covering entire surface of affected site. Very large bruise at injection entry. Treated with Benadryl, hydrocortisone cream and cool compresses. Rash cleared in approximately 5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,02/05/2021,7.0,PVT,Advair 500 Claritin 5mg,None,Asthma,Hepatitis B vaccine (unknown brand or lot),"Oranges, singulair","['Injection site bruising', 'Injection site discolouration', 'Injection site rash', 'Injection site warmth', 'Muscle swelling', 'Myosclerosis', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,SYR 1046998,PA,36.0,F,"Around 9:30/10p, about 32 hours after receiving the vaccination, my whole body except for my face, hands and below my knees broke out in hives.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,PVT,Lexapro Buspirone Loestrin Probiotic blend Vitamin C Astaxanthin Vegetarian Collagen Rhodiola Magnesium,No,Depression Anxiety Low back pain Idiopathic Hypersomnolence,,No,['Urticaria'],1,MODERNA,SYR 1046999,NY,46.0,F,"Rash appeared on arm one week after the injection. It was approx 6x4 inches. The area was red, raised, hot to the touch and extremely itchy. Treated with ice packs, cortisone cream and Benadryl. As of today area is much improved but not completely resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/20/2021,8.0,OTH,,,,,,"['Erythema', 'Peripheral swelling', 'Pruritus', 'Rash', 'Skin warm']",1,MODERNA,SYR 1047000,FL,69.0,F,"PHARMACIST WAS INFORMED WHILE CALLING TO SET UP APPOINTMENT FOR THE SECOND DOSE OF THE MODERNA COVID VACCINE. PATIENT STATED THAT SHE STARTED HAVING REDNESS, FEVER, SWELLING, AND ITCHING AT THE INJECTION SITE A FEW HOURS FOLLOWING THE INJECTION. SHE STARTED TO DEVELOP RASH AND HIVES SYSTEMICALLY OVER THE NEXT FEW DAYS FOLLOWING THE INJECTION. PRESENTED AT AN URGENT CARE CENTER ON 02/20/2021 AND RECEIVED A STEROID FOR TREATMENT. PHYSICIAN AT THE URGENT CARE CENTER WANTED HER TO RECEIVE THE 2ND DOSE.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,PHM,,,,,LATEX,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Pyrexia', 'Rash', 'Urticaria']",1,MODERNA,IM 1047001,FL,65.0,F,"Patient reported feeling dizzy after few minutes of receiving the vaccine. No air way compromised, vital BP: 164/84, HR: 103, SpO2: 100.83. TAKEN TO THE HOSPITAL BECAUSE HISTORY OF ADVERSE REACTION TO PENICILLINE AND LEPTOSPIROSIS VACCINE.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PUB,unknown,NO REPORTED,UNKNOWN,LEPTOSPIROSIS VACCINE,PENICILLIN AND ADVERSE REACTION TO LEPTOSPIROSIS VACCINE,['Dizziness'],2,MODERNA,IM 1047002,GA,59.0,F,"swelling, hot to touch with tenderness, enlarge lymph node right side of neck, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,WRK,Glipizide Plavix Effexor Coreg Vitamin E Omega 3 Lantus Jardinance,diabetes hypertension heart stent,diabetes hypertension heart stent,,Codiene,"['Lymphadenopathy', 'Pyrexia', 'Skin warm', 'Swelling', 'Tenderness']",2,MODERNA,IM 1047003,CA,37.0,F,"Patient was observed for 30 minutes following her vaccine and then was dismissed of, symptom free. She then returned after 12 minutes complaining of feeling hot and flushed and throat, face and arms itching. Her O2 sat was 99% on room air, heart rate 71, respiratory rate of 18. She was given Benadryl 50 mg PO and after 10 or 15 minutes stated she did not have any of noted symptoms any longer.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PVT,Levothyroxine,na,"Hashimoto thyroiditis, IBS",,"Sulfa, shellfish","['Feeling hot', 'Flushing', 'Pruritus', 'Throat irritation']",1,PFIZER\BIONTECH,IM 1047004,UT,79.0,F,Temp 101.8 for about 30 hours. Vomiting multiple times in 24 hour period.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PVT,"Valcyclovir, Levothyroxin, Tramadol, Sotalol, Zinc, Vitamin C, Calcium",None,"atrial fib, V-Tach, thyroidectomy",,Pennicillin,"['Body temperature increased', 'Vomiting']",2,MODERNA,SYR 1047005,TX,51.0,F,"itchy, red, fir, swollen site and Headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,PVT,UNK,UNK,UNK,,UNK,"['Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 1047006,IL,79.0,F,Patient received COVID- 19 (Moderna) Vaccine on 2/20. She reported for a follow up appointment with her PCP 2/22 and reported redness and swelling at the injection site. Patient's PCP diagnosed her with cellulitis and prescribed 10 days worth of Keflex for treatment.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,PVT,"albuterol (PROVENTIL, VENTOLIN) (2.5 MG/3ML) 0.083% Nebulizer Soln ALBUTEROL 108 (90 Base) MCG/ACT Aerosol Solution amLODIPine (NORVASC) 5 MG Tablet atorvastatin (LIPITOR) 40 MG Tablet butalbital-acetaminophen-caffeine-codeine (FIORICET",,"Centrilobular emphysema (HCC) 9/26/10 DM (diabetes mellitus) Hyperlipidemia COPD with acute exacerbation (HCC) 3/28/15 4/30/2015 CKD (chronic kidney disease) stage 3, GFR 30-59 ml/min 5/14/15 Essential hypertension 9/26/10 Chronic diastolic congestive heart failure (HCC) Pulmonary hypertension due to chronic obstructive pulmonary disease (HCC) 3/31/16 COPD (chronic obstructive pulmonary disease) (HCC) 5/11/17 Acute on Diastolic �chronic congestive heart failure (HCC) 5/11/17 9/25/2019 Hypothyroid 5/22/17 Acute renal failure superimposed on stage 3 chronic kidney disease (HCC) 2/20/18 4/2/2018 Stage 4 chronic kidney disease (HCC) 3/18/19 6/4/2019 Acute respiratory failure with hypoxia (HCC) 4/17/19 6/4/2019 Acute systolic heart failure (HCC) 4/18/19 6/4/2019 Acute respiratory failure with hypoxia (HCC) 7/24/19 11/20/2020 Chronic anticoagulation 9/17/19 Chronic deep vein thrombosis (DVT) of right upper extremity",,Carafate [sucralfate] Celexa [citalopram Hydrobromide] Hydralazine Hydrocodone Meperidine And Related Morphine Xanax [alprazolam],"['Cellulitis', 'Injection site erythema', 'Injection site swelling']",2,MODERNA,IM 1047007,NJ,44.0,M,Acute diverticulitis (first ever episode) and peritonitis,Not Reported,,Yes,Not Reported,,Not Reported,Y,01/12/2021,02/09/2021,28.0,PVT,"Metformin, Vitamin D, Vitamin B12, Vitamin C",None,None,,Penicillin,"['Computerised tomogram', 'Diverticulitis', 'Peritonitis', 'Scan with contrast', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 1047008,KY,82.0,U,RECEIVED BOTH DOSES OF PFIZER COVID-19 VACCINE ON 01/31/21 & 02/21/21. ON 02/22/21 WENT TO ER WITH COMPLAINTS OF TACHYCARDIA AND SHORTNESS OF BREATH. PLAN TO ADMIT TO HOSPITAL DUE TO INCIDENCE OF SVT.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/21/2021,02/22/2021,1.0,PVT,,,,,ACE INHIBITORS DARVON MORPHINE PENICILLINS SULFA ANTIBIOTICS CORTIZONE-5,"['Brain natriuretic peptide increased', 'Dyspnoea', 'Electrocardiogram abnormal', 'Supraventricular tachycardia', 'Tachycardia']",1,PFIZER\BIONTECH,IM 1047009,NY,79.0,F,"PAIN IN BOTH ARMS, CHILLS, WHOLE BODY ACHED",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,OTH,"A-Z VITAMINS, ATORVASTAIN, BACLOFEN ,BALSALAZIDE, CRESTOR, DULOXETINE, FOLTANX,HYDROCHLOROTHIAZIDE,TOVIAZ, TRAMADOL, 8 HR. TYLENOL, WARFARIN, CALTRATE + D & VITAMIN D3","NEUROPOTHY IN FEET, LEG VEIN PROBLEMS","NEUROPOTHY IN FEET, LEG VEIN PROBLEMS, SPASMS IN BOTH EXTREMITIES, BLADDER PROBLEM(INCONTINENCE)OBESITY",,LYRACA & ADHISIVE TAPE,"['Chills', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 1047010,,33.0,F,"Almost immediately my arm was sore (as expected). However, about 7 hours after the shot I developed a fever (101), body aches, weakness, reduced O2 saturation (95-95), tightness in my chest, fatigue, nausea, and headache. These symptoms were severe and persistent from 8pm 2/19 through overnight on 2/21. I treated it with Extra Strength Tylenol 1,000mg every 6 hours like clockwork, hydration and rest. I slept about 18-20 hours each day (Saturday and Sunday). I awoke on 2/22 with only fatigue, sporadic tightness in my chest and O2 at 95 remaining. As of today 2/22 at 2:40pm the tightness in my chest has gone and my fatigue is gone. I do not know my O2 saturation right now as I left my reader at home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,WRK,"Birth control - brand not known right now Extra Strength Tylenol 1,000mg as needed for pain",I had COVID-19 in December 2020 - diagnosed positive on 12/26/2020,Irritable Bowel Syndrome Generalized Anxiety Disorder,,"Skin Allergies to many common household items (lotions, soaps etc.) - result in hives, rash, on face, scalp, chest, neck, ears, and back (all skin above bellybutton)","['Asthenia', 'Chest discomfort', 'Fatigue', 'Headache', 'Immediate post-injection reaction', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 1047011,KY,38.0,F,"Patient reports she had numbness in her tongue for approx 24 hours after Moderna Covid 19 Vaccine dose #1. Pt also reports approx one week after receiving first dose of Moderna Cov19 vaccine she had edema to left side of face. Nurse suggest patient consult with per PCP before receiving 2nd dose of Monderna Covid19 vaccine. Pt called her PCP office, who suggested not to receive 2nd dose of vaccine. Patient currently declines to receive 2nd dose at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,PUB,,,,,,"['Face oedema', 'Hypoaesthesia oral', 'Incomplete course of vaccination']",1,MODERNA,IM 1047012,CO,67.0,F,"Throat was closing up, had heart palpitations and trouble catching her breath; alarmed her that her heart was beating fast.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PVT,Multiple,None,"diabetes 2, hypothyroidism, hyperparathyroidism, GERD, sleep apnea, bipolar",flu vaccine 2019,"Allergies to flu vaccine, iodine, latex, adhesives, percoset, vicodin, morphine, flagil, macrobid, bactrim","['Dyspnoea', 'Heart rate increased', 'Palpitations', 'Throat tightness']",1,MODERNA,IM 1047013,IL,73.0,F,Red rash at site of injection. started out splochy and then filled in,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,PHM,No,nonw,NO,,muscle relaxants,"['Injection site reaction', 'Rash erythematous', 'Rash macular']",1,MODERNA,IM 1047014,NY,85.0,M,Severe muscle spasm in lower left side of back,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/13/2021,4.0,PVT,"Eliquis, clonazePAM, hydroCHLOROthiazide, losartan, metoprolol, montelukast, rousuvastatin, silodosin",None,"Heart Condition - afib: urological issues, spinal stenosis, scoliosis",,None,"['Muscle spasms', 'X-ray']",2,MODERNA, 1047015,,36.0,F,C/o red rash at injection sits extending to upper chest and neck. Denies itching. 1:13pm evaluated by EMS. BP 171/113. Recheck improved. Discharged home with significant improvement in rash.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,,,,1st dode of Moderna client had same reaction but more severe.,,"['Chest pain', 'Injection site rash', 'Neck pain', 'Rash erythematous']",2,MODERNA,IM 1047016,MT,28.0,M,"Fever, Chills, & Nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Chills', 'Nausea', 'Pyrexia']",2,MODERNA,IM 1047017,PA,57.0,F,"Pt. presents today with itching post receiving 1st pfizer covid vaccine on 2/22/21 to right arm on 2/22/21 at 14:38 pm/ Pt. states that she started having itching shortly afterwards. Pt. denies shortness of breath, denies",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,OTH,none,none,none,PNEUMONIA-ITCHING,"cipro, Bactrim, morphine, percocet",['Pruritus'],1,PFIZER\BIONTECH, 1047018,NY,35.0,F,"About 3 hours after the injection, I was hit all of a sudden with extreme fatigue and dizziness. This lasted several hours until a took a 2-3 hour nap after lunch. I felt better enough after the nap to at least get through the rest of the day. However, by around 8 pm I had uncontrollable shaking chills. Could not get warm. Eventually fell asleep, and woke up 3 hours later with fever and severe body aches. My temperature was 101.5, but consider that my normal body temp is a full degree lower than average, so for me this was extremely hot. I felt like my body was radiating heat like a furnace. I was so hot and uncomfortable that I couldn't sleep, and gave up after an hour. I got up and had a Tylenol, tea, and snack (so as to not have the Tylenol on empty stomach). A little before 4 am I finally fell asleep again. When I woke up around 7 am, I didn't feel quite so hot anymore but there were still the body aches. As the morning went on, the aches reduced to just my upper body, neck, and the sore injection arm. I had a headache through the morning and early afternoon, but by late afternoon I was feeling more normal again.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,SCH,"Multivitamin, Omega, D, probiotic",None,PCOS,,"Nickel, ragweed","['Chills', 'Discomfort', 'Dizziness', 'Fatigue', 'Feeling hot', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia', 'Sleep disorder']",2,MODERNA,IM 1047019,AZ,61.0,F,"Vomiting, rash, dizziness, weakness",Not Reported,,Yes,Yes,4.0,Not Reported,Y,01/12/2021,01/12/2021,0.0,OTH,"Atorvastatin, omerprazole, vitamin C, multi vitamin",,,,"Penicillin, latex","['Asthenia', 'Dizziness', 'Laboratory test', 'Rash', 'Vomiting']",1,PFIZER\BIONTECH,SYR 1047020,NY,54.0,F,"A week post-injection, developed systemic hives. Hives (large and itchy) covered arms, legs, and part of face. Three days thus far.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,OTH,Benicar,none,hypertension (well controlled),,none,"['SARS-CoV-2 antibody test positive', 'Urticaria']",2,MODERNA,SYR 1047021,MD,46.0,F,"Patient was admitted s/p hysterectomy, found to have PE and AKI. Patient treated with heparin drip, transitioned to Eliquis and discharged",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/25/2021,02/14/2021,20.0,PVT,none,,,,NKA,"['Acute kidney injury', 'Hysterectomy', 'Pulmonary embolism']",1,PFIZER\BIONTECH,IM 1047022,NJ,55.0,F,"Initially had some redness and swelling, as expected, but then the redness and swelling returned and is also itchy. Taking allegra, tylenol and topical benadryl to try to control symptoms. Low-grade fever of about a degree or so that varies.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/20/2021,17.0,PHM,"Vitamin D, Synthroid, Advair, Pepcid, Zegerid, Losartan Potassium, Tylenol, SAM-e",None,"Asthma, GERD",,gluten-intolerant,"['Erythema', 'Pyrexia', 'Swelling']",1,MODERNA,IM 1047023,AZ,50.0,F,Broken blood vessel in right eye. Noticed about 20 min after vaxx. No pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/20/2021,0.0,PUB,None,,None,,None,['Eye haemorrhage'],1,MODERNA,IM 1047024,MD,59.0,M,"Tired, sleepy, vomiting , headache for 3 days after shot, no more vomiting from day 4 and forward, but tired, low energy first 5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,MIL,"Pentoxifylline, nifedipine, vitamin D3, cilostazol, nitroglycerin, mupirocin ointment, formula 7 tolnaftate, genvoya",Frostbite on both feet,HIV+,,,"['Asthenia', 'Fatigue', 'Headache', 'Somnolence', 'Vomiting']",1,MODERNA,SYR 1047025,MT,51.0,F,"Chills, Nausea, & Body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Chills', 'Nausea', 'Pain']",2,MODERNA,IM 1047026,NJ,59.0,F,"Low fever, chills, slight aches in joints... sudden onset, reminded me of flu. (Pain at injection site was expected!)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,SEN,,,,,,"['Arthralgia', 'Chills', 'Influenza', 'Injection site pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1047027,MA,73.0,F,I woke up extremely cold and. shaking the day after my injection. I became weak and dizzy . I could not keep my balance and fell head first into the kitchen cabinet. It was extremely hard to get up from the floor since I was very weak. I used a cane to walk around the house for the next two days. My symptoms returned to normal 2 days later.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,UNK,,NONE,,,NONE,"['Asthenia', 'Balance disorder', 'Dizziness', 'Dysstasia', 'Feeling cold', 'Head injury', 'Tremor']",1,MODERNA,IM 1047029,MD,56.0,F,Nausea and Vomiting over 2.5 hours Chills 2 hours Headache 3 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,UNK,,,,,,"['Chills', 'Headache', 'Nausea', 'Vomiting']",2,MODERNA,SYR 1047030,NE,81.0,F,I had some shortness of breath. I had chills. 99.4 temp. I was nauseated but never vomited. irregular heartbeat. very tired most of the day. 3 days later I broke out in a rash on my arm below the injection site and around my arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/20/2021,2.0,PVT,metoprolol atorvastatin Losartan Symbicort Inhaler Albuterol Femcyclovere (cold sores) Hydrochlorothiazide Multi vitamin Probiotic Vitamin D3 Metamucil fiber,couldnt urinate,Ashtma High blood pressure Afib Aortic aneurism at the top of my heart sleep apnea high cholesterol,rash 9 days after the first dose of Moderna and it lasted 10 days,Levaquin Clindamycin Flagel Bactrim,"['Chills', 'Dyspnoea', 'Fatigue', 'Heart rate irregular', 'Injection site rash', 'Nausea', 'Rash']",2,MODERNA,SYR 1047031,MA,71.0,F,"On 2-20-21, nine days after vaccination, there appeared a ""hot pink"" blotch on my left arm about an inch below the injection site. It was not swollen or painful but was a little warm. I called the on-call doctor who suggested cold compresses and wait to see if any other changes. By Monday 2/22/21 it appeared less red but still warm and no change in shape. continue to monitor. Called doctor's office to report same. (My doctor on leave)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/20/2021,9.0,PVT,"Synthroid, Lisinopril, Hydrochlorothiazide, Vit C, Calcium, Multi-vitamin",none,high blood pressure several years,,iodine taken internally,"['Injection site discolouration', 'Injection site warmth', 'Rash macular']",1,MODERNA,IM 1047032,CA,50.0,M,"pt stated that on 2/2/2021 he developed and SOB, choking sensation and fatigue. On 2/3/2021 he went to the ER for these symptoms. His O2 level was 98. He as given EKG, XRAY, tested for pneumonia, heart condition and Covid. All test came back negative. He was diagnosed w/ Acute Bronchitis and prescribed an Inhaler and Mucinex. . On 2/4/2021 pt went to his ENT Dr. where he was scoped for possible cancer reoccurrence. The triage of head and neck was negative for any illness. He was told to continue the Inhaler and Mucinex. On 2/5/2021 he went to his PCP and was told there was nothing they could do for him. Told him to wait about 10 days to see if his symptoms subsided, if not he was going to refer him to a Pulmonologist. From 2/5 to 2/19 the shortness of breath and choking sensation continued but the fatigue had subsided. On 2/19 pt woke up w/ severe SOB and choking sensation so pt went back to the ER. They performed another EKG, CT of neck and lungs, Covid Test, blood work, O2 level was 99 with wheezing symptoms. All test were negative but pt still had SOB. Pt was released and referred to ENT Doctor once again on 2/25 w/ Dr. which they will do another scope where they will go further down. Pt thinks his next option maybe a referral to a Pulmonologist.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/03/2021,2.0,MIL,Levothyroxine,flu like symptoms,"Thyroid condition, Nasopharyngeal Carcinoma, Fibrosis in throat, TMJ/Trismus, Collapsed Right Shoulder, Loss of hearing in left ear, severe mucus issue, etc",,antibiotics,"['Blood test normal', 'Bronchitis', 'Choking sensation', 'Computerised tomogram normal', 'Dyspnoea', 'Electrocardiogram normal', 'Fatigue', 'SARS-CoV-2 test negative', 'X-ray normal']",1,MODERNA,IM 1047033,MI,82.0,F,"Had vaccine on 2/15 , then on 2/16 evening had stroke like symptoms trying to turn the TV channel and could not find numbers on remote. then her friend called and could not formulate words to her on the phone and could not say the words that she was thinking. Then she called her brother who is a doctor and he told her to go to Cardiologist and get in. She was talking normal by the time she talked to him. Adverse reaction was TIA. TIA symptoms lasted 5-10 minutes max per patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/16/2021,1.0,OTH,atenoloL (TENORMIN) 25 mg tablet CALCIUM CITRATE ORAL cholecalciferol (VITAMIN D3) 10 mcg (400 unit) capsule FOLIC ACID/MULTIVIT-MIN/LUTEIN (CENTRUM SILVER ORAL) lansoprazole (PREVACID) 15 mg delayed release capsule losartan (COZAAR) 50 mg,HIATAL HERNIA,"Osteoporosis Atrial fibrillation Intermittent (CMS/HCC) Coronary artery disease AVM (arteriovenous malformation) brain Gastroesophageal reflux disease Hypertension Hyperlipidemia Post-mastectomy lymphedema syndrome Right-sided carotid artery disease (CMS/HCC) Bilateral breast cancer (CMS/HCC) Bilateral primary osteoarthritis of knee Obstructive sleep apnea Hyponatremia SIADH (syndrome of inappropriate ADH production) (CMS/HCC) Closed fracture of one rib of left side with routine healing Sensorineural hearing loss, asymmetrical Osteoarthritis of left knee AVM (arteriovenous malformation) of colon, acquired Anemia, unspecified Poor venous access Disorder of muscle, ligament, and fascia �",,TENUS TOXIN AND PREMARIN,"['Adverse reaction', 'Cerebrovascular accident', 'Magnetic resonance imaging', 'Speech disorder', 'Transient ischaemic attack', 'Ultrasound Doppler', 'Vision blurred']",1,MODERNA,IM 1047034,WA,52.0,M,"Slightly sore arm for a day. Starting ten hours and lasting maybe thirty hours was a series of intense chills and strong, flu=like weakness. From about 24 hours for maybe the next 4 days, significant aggravation of legacy rashes from my chronic skin conditions. After 4 days, they reverted to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,OTH,,,"Rosacia, skin conditions such as folliculitis precipitating a rash. glaucoma.",,,"['Asthenia', 'Chills', 'Condition aggravated', 'Influenza like illness', 'Pain in extremity', 'Rash']",2,PFIZER\BIONTECH,SYR 1047035,TN,73.0,F,"Very dizzy,headache,violate vomiting, pain swelling in arm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PUB,"Famotidine isosorbide atorvastatin, tyanol",None,"Arthritis, thinning bones",,"Codine,fentanol","['Dizziness', 'Headache', 'Pain in extremity', 'Peripheral swelling', 'Vomiting projectile', 'X-ray']",1,MODERNA,SYR 1047036,OH,29.0,F,"after 24 hrs from receiving the second Covid vaccine, I started to feel the typical body aches and low grade fever. However, that evening my lips swelled and my hands and feel swelled along with being itchy on the hands and feet. I took a zyrtec and was better by morning. I did have intense shaking throughout the night and was freezing. I did take 2 doses of ibuprofen during the day on the 21st.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PUB,Zoloft 100mg Vyvance 60mg,none,none,,none,"['Feeling cold', 'Lip swelling', 'Pain', 'Peripheral swelling', 'Pruritus', 'Pyrexia', 'Tremor']",2,MODERNA,IM 1047037,MD,89.0,F,"Patient was admitted for possible CVA, presented with right facial droop. MRI unable to be completed due to pacemaker. Pt was treated and transferred to inpatient rehab",Not Reported,,Not Reported,Yes,6.0,Not Reported,U,01/22/2021,02/14/2021,23.0,PVT,"ascorbic acid, aspirin, atenolol, vitamin d",,"HTN, HLD, CRI",,none,['Facial paralysis'],1,MODERNA,IM 1047038,MT,19.0,F,"Hot and Cold Flashes, Body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Feeling cold', 'Hot flush', 'Pain']",2,MODERNA,IM 1047039,NJ,54.0,M,"After the patient received the second dose of the Moderna vaccine, he experienced Bell face. After two days time, he was okay, and was not experiencing any other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,UNK,,,,,,['Facial paralysis'],2,MODERNA,IM 1047040,,68.0,M,"Pt admit 2/16 with angioedema after receiving Moderna COVID-19 vaccine 2/4/21 given at store. He was treated with benadryl, pepcid and solu-medrol and symptoms improved. 2/17 solu-medrol dose decreased from 60mg bid to 40mg daily. ADR admitted to VAERs and Moderna. Pt discharged in stable condition.",Not Reported,,Not Reported,Yes,4.0,Not Reported,,02/04/2021,02/16/2021,12.0,PVT,,,,,,['Angioedema'],1,MODERNA,SYR 1047041,PA,41.0,F,"Raised rash that was warm to the touch, wasn?t painful but made the arm feel tingly and tired, similar to a flu shot. Seeker care at a clinic where they told me I had cellulitis from the injection site. Prescribed an antibiotic for 7 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/12/2021,7.0,PHM,Women?s one a day vitamin Vitamin c Vitamin d,,"Sinus issues often, seasonal allergies",,None known,"['Injection site cellulitis', 'Muscle fatigue', 'Paraesthesia', 'Rash', 'Rash papular', 'Skin warm']",1,MODERNA,SYR 1047042,MS,77.0,F,"Chills, fever, nausea, body aches for about 36 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,UNK,"Low dose aspirin,losartan, tamoxifen",,"Heart disease obesity,kidney disease",,,"['Chills', 'Nausea', 'Pain', 'Pyrexia']",UNK,MODERNA, 1047043,FL,66.0,F,"At 3 a.m. on the 21st, approximately 18 hours after vaccine, got up to go to the bathroom. Felt weak and passed out on bathroom floor.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PHM,Crestor and Montelukast,None,Asthma,,NSAIDS,"['Asthenia', 'Loss of consciousness']",UNK,MODERNA,IM 1047044,TX,69.0,M,"Involuntary movements on my right hand finger (index) Contacted Moderna for clarification, they said that it was up to me to receive the second dosis since it was not approved by CDC. I was supposed to have the second shot last weekend, I did not take. The Moderna employees referred me to to the fact sheet of the vaccine. One of the components is PEG-2000, Polyethylene Glycol. Reading the CAS it says that this product is not to be used by animals or humans. Please clarify",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,02/09/2021,0.0,PVT,"Lipitor, Hytrin",No,BPH,,No,"['Dyskinesia', 'Incomplete course of vaccination']",1,MODERNA,SYR 1047045,NY,35.0,F,"Reported body aches, fever 100.6F, and headache. 1st dose administered on 1/28/21 Pfizer EL9262 / 2nd dose administered on 2/18/21 Pfizer EN5318",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/18/2021,0.0,PVT,,,,,,"['Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1047046,NC,66.0,F,after 30 minutes of observation patient was c/o tingling tongue. Benadryl 50 mg given by Physician Assistant and patient was observed for 25 more minutes. Patient stated she felt better and was released.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,PUB,unknown,unknown,unknown,,xylocaine,['Paraesthesia oral'],1,PFIZER\BIONTECH,IM 1047047,AL,90.0,M,"Significant fatigue - Notable in 91 year old lady, with associated fall - Began day following injection and persisting at least three weeks later",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/30/2021,1.0,PVT,"Aspirin 81 mg PO daily, Zyrtec 10 mg PO daily, Tylenol 500 mg PO q6h, Levothyroxine 66.25 mcg daily, Zocor 40 mg PO daily, Cymbalta 30 mg PO daily, amlodipine 5 mg PO daily, Lisinopril 10 mg PO daily, Trileptal 150 mg PO BID,",Brief flare of trigeminal neuralgia two weeks earlier,"Hypothyroidism, Essential hypertension, Hyperlipidemia, Trigeminal neuralgia, osteoporosis, Anemia of chronic disease, Generalized osteoarthritis",,"Codeine, Tramadol, Benadryl, Zinc oxide, Cortisone, Peniccillin, Endal CD","['Fall', 'Fatigue']",1,MODERNA,IM 1047048,MT,40.0,F,"Sore Arm, Headache, Nausea, & Body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Headache', 'Nausea', 'Pain', 'Pain in extremity']",2,MODERNA,IM 1047049,MA,44.0,F,difficulty swallowing- felt like food was stuck in the esophagus approx 30 mins after vaccination was administered. i had a sip of iced tea and stopped eating. This was resolved after about 45 mins.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,UNK,None,Sinus/Ear Infection weeks prior to 2nd vaccine,Overweight,,Sulfa Codeine,"['Dysphagia', 'Sensation of foreign body']",2,MODERNA,IM 1047050,PA,58.0,F,"itching, facial and lip swelling and wheezing /SOB",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,OTH,"Humera ( not the same day ) cetirizine, omeprazole, ginger, biotin, flaxseed, multivitamin, mag, turmeric and zinc",none,"seasonal and non-seasonal allergy , asthma , ankylosing spondylitis , depression",,"adhesive tape, pcn and latex and other environmental allergy","['Dyspnoea', 'Lip swelling', 'Pruritus', 'Swelling face', 'Wheezing']",1,MODERNA,IM 1047051,,80.0,M,Dizzyness/vertigo,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/10/2021,02/18/2021,8.0,UNK,"metformin, sulfasalizine, bisoprolol, irbsartin, xeralto",,"diabetes, a-fibs, UC, HBP",,none,"['Dizziness', 'Vertigo']",1,PFIZER\BIONTECH,IM 1047053,FL,75.0,F,"C/O LEFT ARM SORE, RED, PUFFY AND ITCHING X6 DAYS AFTER 2ND VACCINE GIVEN ON 2/16/21. CLIENT WENT TO URGENT CARE AND WAS DIAGNOSED WITH CELLULITIS.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/20/2021,4.0,PUB,Metoprolol; Lasix; Meclizine; Macrobid; fluconazole; Imipitrium inhaler; aspirin 81mg; losartan; hydrocodone; pantoprazole; reseuvastatin; baclofen,UTI,Hypertension; Diabetes; COPD; CAD-stent,,Azithromycin,"['Cellulitis', 'Erythema', 'Pain in extremity', 'Pruritus', 'Skin swelling']",2,MODERNA,IM 1047054,NY,72.0,F,Erythema about 3 inches in size around vaccination site with itching,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/15/2021,7.0,PVT,Levothyroxine 75 mcg. daily Centrum Silver daily,none,mild COPD,,cat and horse dander,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 1047055,CA,85.0,M,"Aprox. 5 minutes post vaccination patient complained of dizziness. When interviewed he stated he had not had any water only coffee today. Patient was provided a bottle of water to sip on while he finshed waiting in the vechile for observation for 15 min. About 5 mins later, checked on patient and patient reported to be doing fine, no complaints and dizziness had resolved. 5 minutes later patients wife called over observation staff reporting patient was having chest pain. Patient appeard altered, but with history of dementia. 911 was called and patient was transported via ambulance. Complaining of 5/10 dull pain in his left upper chest improved when given nitroglycerin en route ED department. No SOB and patient denies ever having pain like this in the past. Observed in the ED for approx 6 hours. Patient then discharged home. Per ED provider ""85 y/o male who presents w/ CP s/p COVID vaccine inj. Low clinical suspicion for acute cardo pul pathology give atypical hx, neg ED workup. No recurrence of sx while being observed in ED. Dc w/ con sx care, f/u PCP",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PVT,"Paroxetine, aspirin, donepezil, ezetimibe/simvastatin, fludracortisone, lisinipril, rivastigmine",,"CAD, HTN, seizures, dementia, s/p bypass, s/p cardiac pacemaker placement",,NKA,"['Altered state of consciousness', 'Chest pain', 'Dizziness', 'Troponin']",1,MODERNA,IM 1047056,MT,54.0,F,"Fever, Chills, & Body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Chills', 'Pain', 'Pyrexia']",2,MODERNA,IM 1047057,KY,49.0,F,"RECEIVED BOTH DOSES OF PFIZER COVID-19 VACCINE ON 01/21/21 & 02/11/21. ON 02/21/21 REPORTED TO ER WITH COMPLAINT OF LEFT ARM PAIN (TINGLING, HEAVY SENSATION). DIAGNOSED WITH PARESTHESIA OF LEFT UPPER EXTREMITY, GOITER, AND DEGENERATIVE DISC DISEASE. DISCHARGED TO HOME SELF CARE.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/21/2021,10.0,PVT,,,,,LATEX ZYRTEC CHLOHEXIDINE,"['Goitre', 'Intervertebral disc degeneration', 'Limb discomfort', 'Pain in extremity', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 1047058,MD,48.0,F,"Patient admitted after syncopal episode, found subsequently to have a splenic artery aneurysm for which surgery not recommended. Pt was discharged on small-dose anxiolytic",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/08/2021,02/14/2021,37.0,PVT,,,,,Penicillins (rash),"['Splenic artery aneurysm', 'Syncope']",2,PFIZER\BIONTECH,IM 1047059,PA,62.0,F,Itchy rash at injection site one week after administered. Stopped itching soon after. Faded over the next week,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/19/2021,7.0,OTH,"Hydrochlorithiazide, vitamin D, biotin, flaxseed oil.",None,Epstein Barr - currently dormant,,None,"['Injection site rash', 'Rash pruritic']",UNK,MODERNA,SYR 1047060,AZ,55.0,F,Left lateral neck pain approximately 5 minutes after vaccination. Pain is rated at a 2 out of 10. Symptoms persisted until she left 20 minutes after vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/26/2021,0.0,PUB,"Metformin, Levothyroxin",,"Diabetes, Thyroid",,NKDA,['Neck pain'],1,MODERNA,IM 1047061,PA,74.0,F,"Generalized rash legs and arms. Red,warm facial cheeks under mask. Mild bronchospasm better with albuterol. Resolved in 3 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PUB,Atorvastatin,None,"Asthma, celiac",,"Aspirin, quinolone,tetracycline,NSAIDS","['Bronchospasm', 'Erythema', 'Feeling hot', 'Rash']",1,MODERNA,IM 1047062,IN,64.0,F,Elevated blood sugars into the 300's. Started next day and have persisted for 4 days requiring me to contact my physician.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/17/2021,0.0,PHM,"Novolog insulin. Lanus insulin. Simvastin. Clonazepam. Vit E, b6, b12. Hctz. Zoloft. Estradiol. Zyrtec. Colace. Fibercon. Levothyroxin. Meclazine hcl.",,Diabetes type I. Meneirres disease.,,Sulfa,['Blood glucose increased'],1,MODERNA,IM 1047064,NY,44.0,F,"Patient reports that she received the injection ""high up"" on her shoulder and she thinks that the injection may have gone in to the joint. She had excruciating pain for 48 hours, especially if she tried to move it. It was better after 4 days, but still is uncomfortable 4 weeks later, when she reported this to us. She reports that she will go to her PCP if the pain does not resolve totally. She has been doing ROM excerises that her cousin who is a PT has recommended for her.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/22/2021,0.0,PUB,,,,,,"['Injected limb mobility decreased', 'Injection site discomfort', 'Injection site joint pain', 'Pain', 'Product administered at inappropriate site']",1,MODERNA,IM 1047065,CA,71.0,F,"4 days after the vaccine, I had EXCRUCIATING nerve pain, starting at the upper vertabrae and shooting down both arms to fingertips. Sometimes all the way down my back and the back of my legs. I vomited all day, had a low fever which lasted for 24 hours, then the pain and fever subsided. Still have nausea but no more vomiting . I went to a doctor after that, he also thinks it was a reaction.. On the 7th day, a purple splotchy rash showed on my skin and my hands started swelling up at night, so painful I couldn't even pull up the sheet. The hand swelling goes down during the day and comes back at night. I plan to get an antibody test on Feb. 26. I am 98% certain that I had COVID in July, it was precisely the same symptoms and I had with the vaccine. No treatment, just resting tilll it's over. I am almost 80% better now, but not completely. I worry that I will never get back to 100%, it's been 11 days now.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/16/2021,4.0,OTH,"Atenolol, celexa, meloxicam, baby apririn, amlodipino,",none,"Rheumatoid Arthritis, Sjogrens",,sensitive skin,"['Back pain', 'Grip strength decreased', 'Nausea', 'Neuralgia', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Rash', 'Rash macular', 'Spinal pain', 'Vomiting']",1,MODERNA,SYR 1047067,NE,79.0,F,"Seven days after receiving the vaccine, the patient's right arm itched, and she reached up to scratch it, and noticed that the area around the deltoid was red. The area does not really itch, but is just red. For the first two days, the rash didn't move. Then over the next several days, the rash starting spreading down the upper arm. On February 18, the patient experienced bad diarrhea. On February 21, the patient put a cold damp cloth over the area to soothe the area. Some areas within the rash are improving, but the redness continues to spread down the arm. The area felt like a bad sunburn, and the patient put some salve on it one day, but did not notice a difference.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/16/2021,7.0,PVT,Tylenol Alkaselser Stool Softener (OTC),,Ulcerative colitis -- managed via surgery.,,Sulfa -- sick stomach,"['Diarrhoea', 'Erythema', 'Injection site erythema', 'Injection site pruritus', 'Rash', 'Sunburn']",1,MODERNA,IM 1047068,VA,31.0,M,Initial attempt to administer vaccine in LA was unsuccessful due to vaccine leaking from syringe. Second attempt to vaccinate performed by clinical instructor Dr. and was successful in administering full dose in RA.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,OTH,,,,,NKDA,['Syringe issue'],1,MODERNA,IM 1047069,MA,25.0,F,"Day 6, woke up with swollen armpit/lymph node and pain on left side. Day 8, lump at injection sight, including red, itchy, and warm to touch",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/20/2021,6.0,PHM,"Depo Provera injection, Adderall 10 mg/day, Sertraline 100 mg/day, Vitamin B2 100mg/day; epipen as needed for food allergies",None,Endometriosis,,"Some tree nuts (walnuts, pecans, pine nuts) - anaphylaxis","['Injection site erythema', 'Injection site mass', 'Injection site pruritus', 'Injection site warmth', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 1047070,CA,80.0,F,"Sore arm, fatigue, muscle aches, loss of appetite.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PVT,synthroid .50,none,cervical arthritis,,,"['Decreased appetite', 'Fatigue', 'Myalgia', 'Pain in extremity']",2,MODERNA,IM 1047071,OK,71.0,F,Pt developed rash on back. This was her second dose. She feels it is getting better. She states it is not itching. I advised her to call her physician as well.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/22/2021,1.0,PHM,,,,,,['Rash'],2,MODERNA,IM 1047072,CA,62.0,M,"Patient had sore arm on the day of vaccination. Per patient's nephew , the next morning patient experienced body pains, aches, headache . Onn Tuesday patient had fever. Patient's condition progressively got worse. He had difficulty breathing by Wednesday night. He had low oxygen levels at 80 per pulse ox reading. Patient was coughing up blood. Family took him to hospital on Thursday morning due to breathing difficulty and patient died 2.18.21 at 10 am",Yes,02/18/2021,Not Reported,Yes,1.0,Not Reported,N,02/13/2021,02/14/2021,1.0,PHM,"Topamax,","COPD, seizures( patient on medications and controlled), Hernia operation 2 years ago","COPD and seizures, asthma",,"no allergies to medications, or food but allergic to cats","['Death', 'Dyspnoea', 'General physical health deterioration', 'Haemoptysis', 'Headache', 'Oxygen saturation decreased', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1047073,IL,36.0,F,"FATIGUE, NAUSEA, MUSCLE PAIN, CHILLS, ANS SORENESS IN OTHER BODY PARTS.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/20/2021,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Myalgia', 'Nausea', 'Pain']",1,MODERNA,IM 1047074,OH,82.0,M,"Excessive sleeping, hand shakes and had trouble holding spoon and fork. Use walker and could not balance (very groggy). Kept wanting to fall. Had to have wife help to get into bed on Friday night. Saturday was better, but still needed help. Sunday better and today Monday doing better. If Moderna second shot is known to be much worse for side effects, should it be taken?",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/01/2021,,PHM,"Metoprolol Tartrate 50, , Sertraline Hci 25mg,Tamsulosin Hyd. 0.4 mg,Sulfamethoxazole 800-160mg tab",,,,,"['Balance disorder', 'Fall', 'Hypersomnia', 'Mobility decreased', 'Motor dysfunction', 'Somnolence', 'Tremor', 'Walking aid user']",1,MODERNA,SYR 1047075,IN,73.0,F,strong unpleasant taste in my mouth since the vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/11/2021,2.0,PVT,"Omeprazole 40 mg, Atenolol 100 mg, amLODIPine 5 mg. Atorvastatin 20 mg, hydrOXYzine 25 mg, Senior complete multivitamin, Vitamin D3, Vitamin C",none,arthritis and spine stenosis,,"Cefdinir, Levaquin, Lisinopril, Naprosyn, Pentothal, various trees and grasses, fungi, dust mites",['Taste disorder'],UNK,PFIZER\BIONTECH, 1047076,UT,67.0,F,"Blurred vision, benign vertigo, immediately after vaccine given. Corrected itself over the next hour. But at 4:30 am 2/22/2021 I was awakened by intense itching on my left arm and hand. Over the next 2 hours the itching increased in intensity and progressed to my right arm and hand, over my upper back and shoulders, and along the back of my thighs and buttocks. I took 2 Benadryl allergy tablets (25mg) and used Benadryl GEL extra strength on the affected areas. This resulted in my sleepiness for the remainder of the day. Contacted my physicians office for an appointment to resolve the issue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/22/2021,2.0,PUB,"Atorvastatin Calcium 10mg Losartan Potassium 25mg Multi vitamin, calcium, glucosamine",None,Vertigo; disc damage in neck and lumbar area; sciatic nerve damage.,,"Demerol, sulfa drugs","['Immediate post-injection reaction', 'Pruritus', 'Somnolence', 'Vertigo', 'Vision blurred']",1,PFIZER\BIONTECH, 1047077,OH,67.0,F,Severe chills the first night. Severe headache all of the second day despite taking Tylenol. Sore arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,"Atenonol 50 mg 2x a day Pravastation 40 mg 1x a day Amlodipine besylate 5mg 1x a day Latanoprost ophthalmic Solution ).))5% Vitamin D 1,000 IU 1x a day Elderberry gummies",Hypertension,Hypertension,,none known,"['Chills', 'Headache', 'Pain in extremity']",1,MODERNA,SYR 1047078,NY,50.0,F,"C/O hive/rash, itchiness, stated had itchiness with first dose of Moderna Vital signs taken all WNL, stayed for 30 minutes and discharged to home",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,OTH,"hydrochlorothiazide, Irbesartan, fluoxetine, fenofibrate, metformin, lorazepam, ventolin, HFA, albuterol calcium citrate",,,,"bee stings, amoxicillin, PCN, arythomycin","['Pruritus', 'Rash', 'Urticaria']",2,MODERNA,IM 1047079,MO,55.0,F,FIRST ROUND ONLY A SORE ARM FOR A FEW DAYS. SECOND ROUND ON 2/20/21 AFTER A FEW HOURS I STARTED TO HAVE HOT FLASHES WITH FEELING THE CHILLS.. IN THE EVENING MY LEFT HAND WAS LIKE ICE BUT MY RIGHT SIDE WAS NORMAL AND WARM. CHILLS / NO FEVER . COLD HAND WAS GONE IN THE MORNING.. ABOUT 5 AM HORRIBLE HEADACHE WITH BLURRED VISION... TOOK TYLONAL AT 9AM.. FELT BETTER BY 11AM. CHILLS/AND SLEPT MOST THE DAY. I DO NOT BELIEVE I EVER HAD A FEVER. SUNDAY LEFT ARMPIT LYMPH NODES SWOLLEN AND SORE. MONDAY FEELING BETTER BUT LYMPH NODES STILL ACHE LIKE A BRUISE. I DO NOT BELIEVE I EVER HAD A FEVER.. JUST CHILLS. OH>>>. RIGHT SIDE OF MY NECK WAS STIFF FOR A BIT THE FIRST DAY.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,OTH,none,none,skin cancer,,none,"['Chills', 'Headache', 'Hot flush', 'Lymph node pain', 'Lymphadenopathy', 'Musculoskeletal stiffness', 'Pain in extremity', 'Peripheral coldness', 'Vision blurred']",1,PFIZER\BIONTECH, 1047080,NJ,37.0,M,"About 3 hours after receiving the shot my arm was sore. The next day my arm was still sore. The pain in my arm lasted about 2 days. The following day about 48 hours after receiving the vaccine, I got a pain in my lower back. I have been doing stretching, heat, massage and OTC pain relievers. The pain in my lower back is serve, I couldn't really stand up straight. I have had to miss a few days of work. I have talked to a family friend who is a Doctor and he said it should only last for a 1-2.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/18/2021,2.0,OTH,,,,"do not remember the details, but as a child a vaccination caused pain in my back.",,"['Back pain', 'Pain in extremity']",1,MODERNA,SYR 1047081,FL,72.0,F,"5 days after the injection, I started having intense itching at the injection site. 7 days after injection, I have an itchy, red, hot circle rash around the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,PHM,"Lisinopril HCTZ, Meloxicam, Glipizide ER, multivitamin",None,"Hypertension, Diabetes",,"Morphine, Penicillin","['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,SYR 1047082,VA,56.0,F,"Began with achiness on the evening of 2-18-21 7 am 2-19-21: fever of 100.8 degrees, chills, aches particularly in wrist and ankle joints, moderate headache all of which continued through to 7 am on 2-20-21 7am on 2-21-21 noted presence of rash near injection site that was red, raised like a welt and slightly itch about the size of a dollar bill. Also noted dime sized welt on left shoulder that was tender to touch. As of 4:00 PM 2-22-21 the rashes remain and look like they are beginning to resolve. I took 500 mg of Tylenol per directions on package for 24 hours for flu like symptoms and Benadryl for rashes in the evening.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,OTH,"Synthroid .25 mcg, vitamin C 500 mg slow release, multi-vitamin, vitamin D-3 50 mcg, Allegra 90 mg",None,Hypothyroidism,,"Sulfa , Zithromax , Yaz, MSG","['Arthralgia', 'Chills', 'Headache', 'Influenza like illness', 'Injection site pain', 'Injection site reaction', 'Pain', 'Pyrexia', 'Rash erythematous', 'Rash papular', 'Rash pruritic', 'Urticaria']",2,MODERNA,SYR 1047083,FL,40.0,F,CHILLS IN THE MIDDLE OF THE NIGHT. MUSCLE ACHES ALL OVER BODY. SHARP SHOOTING PAIN IN BOTH LEGS AND RIGHT ARM. SKIN WAS SENSITIVE TO TOUCH. RASH ON RIGHT ARM NEAR INJECTION. TOOK 800 MG IBUPROFEN EVERY 8 HOURS. STARTED FEELING BETTER NEXT DAY AT 8 AM.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PVT,NONE,NONE,NONE,,NONE,"['Chills', 'Injection site rash', 'Myalgia', 'Pain', 'Pain in extremity', 'Sensitive skin']",2,MODERNA,IM 1047084,MT,40.0,F,Lymph node swollen under left arm,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,PVT,,,,,,['Lymphadenopathy'],2,MODERNA,IM 1047085,MD,80.0,F,"Patient admitted for vertebral osteomyelitis and discitis, being treated with antibiotics. Patient remains in hospital",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,02/10/2021,02/16/2021,6.0,PVT,,,"afib, CHF, diabetes type 2, HTN, hx of DVTs",,,"['Intervertebral discitis', 'Osteomyelitis']",1,PFIZER\BIONTECH,IM 1047086,NY,64.0,F,"Migraine Headache, Fever, Muscle Ache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/22/2021,1.0,SCH,Losartan Hydrochlorothyzine,,High Blood Pressure Weak immune system,,Pennicillun,"['Migraine', 'Myalgia', 'Pyrexia']",2,MODERNA,SYR 1047087,OH,76.0,M,"1. Intestinal upset and no appetite. Re-flux, Stomach Ache, excessive gas in stomach and colon. 2. Muscle and joint aches strong enough to remain in bed or a chair ""attempting Not to move"" 3. Momentary and random loss of balance in excess of normal events in both severity and frequency",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,PVT,"Methylphenidate [Ritalin], Bupropion 150 mg, 50+ Vitamin Supplement , Calcium Citrate + 200 iu D , Magnesium Citrate, Atorvastatin Calcium (A. C.), Levo-Cetirizine, Phillips Tab, Stool Softener [Colace]",,"TBI, Neck pain [Broken Neck stabalized 2002]",,"shell fish,","['Abdominal discomfort', 'Abdominal pain upper', 'Arthralgia', 'Balance disorder', 'Decreased appetite', 'Flatulence', 'Myalgia']",2,MODERNA,IM 1047088,KY,71.0,U,"RECEIVED 1ST DOSE OF PFIZER COVID-19 VACCINE ON 02/13/21. ON 02/21/21 REPORTED TO ICC WITH COMPLAINT OF SINUS PROBLEM (SINUS PRESSURE, HEADACHE, COUGH - ALL GOING ON X1 WK) DIAGNOSED WITH ACUTE RECURRENT FRONTAL SINUSITIS AND SUBACUTE FRONTAL SINUSITIS.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/21/2021,8.0,PVT,,,,,TETRACYCLINE TETRACYCLINE & RELATED ERYTHROMYCIN,"['Acute sinusitis', 'Cough', 'Headache', 'Paranasal sinus discomfort', 'Sinusitis']",1,PFIZER\BIONTECH,IM 1047089,MD,49.0,F,"crushing headache, extreme joint pain, extreme fatigue, Fever starting evening of shot (2/8) lasting until evening of 2/11. TMAX 102.4 F chills loss of appetite",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/08/2021,7.0,PVT,none,none,none,Covid vaccine shot 1,minocycline allergy,"['Arthralgia', 'Chills', 'Decreased appetite', 'Fatigue', 'Head discomfort', 'Headache', 'Pyrexia']",2,MODERNA,IM 1047090,MS,39.0,M,"COVID arm. The afternoon of 2/19, noticed an itchy sensation on my left arm where I received my COVID vaccine shot. The area started to turn red and was warm to the touch. Over the next 2-3 days, the redness continued to grow. The area was slightly itchy but not unbearable. The redness has continued to spread, but seems to be lessen in brightness as of 2/22. Out of curiosity, I used a an IR thermometer, and it read 101 degree F on the red area but only 93-94 on the unaffected area lower on the same arm. Started taking some ibuprofen on 2/21 to see if it would lessen the inflammation. Arm is still red and warm to the touch as of today (2/22). Itchiness seems to have decreased. Contacted my doctor to notify them and also to be sure that there was nothing else to do at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,PVT,"vitamin D supplement, fish oil, one a day men's vitamins, zyrtec, omeprazole, 145mg fenofibrate, 20 mg rosuvastatin, niacin",none,"overweight, high cholesterol in the past but at normal levels",,seasonal allergies to pollen,"['Erythema', 'Inflammation', 'Injection site pruritus', 'Pruritus', 'Skin warm']",1,MODERNA,SYR 1047091,TX,51.0,M,Employee received initial Covid vaccine on 01/04/21 in lt deltoid area and developed pain in left elbow 72 hours post vaccination. Pain began subside over coming weeks and was nearly resolved by 1/22/21 when employee was seen for 2nd vaccine which was given in rt deltoid. EE reported that he had elbow pain but that it was nearly gone at time that he received 2nd dose. 48 hrs post 2nd vaccine EE began to experience sharp severe pain at same lt elbow and pain is still persisting currently. It is interfering with his ability to lift and his grip strength on the left at this time due to severity of pain. He agrees to be evaluated.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,02/22/2021,49.0,PVT,Alive Plus Multivitamin for men over 50,Follicular Adenoma rt thyroid,,,None,"['Arthralgia', 'Grip strength decreased', 'Injection site pain']",2,PFIZER\BIONTECH,IM 1047092,KY,35.0,M,"Received first vaccine on 2/17/21, had left arm soreness and swelling the next day which continued to get worse. Went to urgent care on 2/22/21 diagnosed with vaccine reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/19/2021,2.0,PVT,,,,,NKA,"['Pain in extremity', 'Peripheral swelling', 'Vaccination complication']",1,PFIZER\BIONTECH,IM 1047093,VA,73.0,F,"At 7 days post injection, noted itching and 2-3 inch red lesion at injection site. Treated as allergic reaction, diclofenac gel topical, Zyrtec oral antihistamine. Size monitored with 'Sharpy"" circle. Subsequent increase in size of lesion prompted current course of Doxycycline. Incident on going at this date. Discussed with Doctor - sent photo. No visit.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,PVT,"estradiol, progesterone, fish oil, flax seed oil, zinc, vitamin C, multivitamin, Vitamin D low dose aspirin, ared2",none,"asthma, Barretts esophagus, chronic pancreatitis (inactive)",,"latex, sulfa, codeine","['Injection site erythema', 'Injection site pruritus', 'Skin lesion']",UNK,MODERNA,IM 1047094,TX,56.0,F,Pt reports 4 days after taking the Pfizer COVID vaccine she developed unrelenting pain and soreness to her left arm followed by general myalgias to her body and weakness. She states she sx have not resolved and has only been taking ASA. Rx Voltaren gel and Tizanidine refill given.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/02/2021,5.0,PVT,Zoloft Xanax Singulair Flonase Albuterol Tizanidine,Respiratory infection,Asthma and Gerd,,Sulfa,"['Asthenia', 'Myalgia', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 1047095,FL,52.0,F,"Patient arrived for 2nd dose of Pfizer vaccine. Administered with no difficulty. Approximately 20 mins after receiving vaccine, patient began to report shortness of breath and chest tightness and rash to chest, that continued to worsen. She was brought into the urgent care (on-site) and was evaluated by MD and urgent care team. Intravenous access was established, placed on cardiac monitoring and supplemental oxygen was administered. Benadryl, Pepcid, Epinephrine (2 doses), Solumedrol, normal saline intravenous transfusion was administered. SOB and chest tightness resolved, rash improved. Monitored in urgent care for additional 5 hours, discharged home with prednisone and epi-pen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PVT,None.,Unknown.,History of Asthma.,,No known allergies to food or medications prior to administration of vaccine.,"['Chest discomfort', 'Condition aggravated', 'Dyspnoea', 'Rash']",UNK,PFIZER\BIONTECH,IM 1047096,IL,51.0,F,"Lightheaded, dizziness. Weakness on the side of the injection. No energy and shortness of breath with activity ongoing. Patient normally very active and has not chronic conditions",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,SEN,,No other illnesses. Active individual,None,,NKA,"['Asthenia', 'Dizziness', 'Dyspnoea', 'Hemiparesis']",2,PFIZER\BIONTECH,IM 1047097,MI,44.0,F,"8 days after the vaccine, I developed a blotchy red rash that trailed down my arm from the injection site. The injection site was red, swollen and painful to touch. Mild itchiness noted on that arm. Otherwise, I was fine. Just seemed strange so long after the vaccination. It improved without intervention and was gone within 2-3 days. I did not seek professional help because I read that this reaction was noted with the Moderna vaccine and that it was just considered a mounting immune response and no cause for concern. However, I still thought I should report it. I have since received the second dose of vaccine on 2/19/21. I had moderate side effects starting on 2/20/21 (lasting 15 hours) of fatigue, chills, body aches, joint pain, headache, generalized body swelling, swelling and pain at injection site and brain fog. I didn?t experience a rash (yet- the vaccine was only 3 days ago). Will update if that changes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/31/2021,8.0,PUB,"Aleve, adderall, Pepcid, mirabegron, vitamin d",,"Adhd, knee pain, gerd, overactive bladder",,None,"['Arthralgia', 'Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Pain', 'Rash erythematous', 'Rash macular', 'Swelling']",1,MODERNA,IM 1047098,FL,17.0,F,Vaccination age < EUA age . Patient age 17 and EUA is >18. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,02/01/2021,17.0,PVT,,,,,,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 1047100,MT,28.0,F,Nausea and Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Fatigue', 'Nausea']",2,MODERNA,IM 1047101,NC,39.0,F,"Patient reported itching on chest, red blotchy spots present. Reported itching in palms and all over. Patient evaluated by RN. Denied Shortness of breath or respiratory distress. Medical director was notified and Benadryl 50 mg was given. Patient tolerated this well. Vital signs were taken. Heart rate was-80, SPO2 -100 %, Blood Pressure was 118/72. Itching improved and patient was released after being observed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PUB,unknown,unknown,unknown,,"bee stings, cipro, sulfa, augmentin","['Erythema', 'Pruritus', 'Rash macular']",2,PFIZER\BIONTECH,IM 1047102,WA,74.0,F,"day of vaccine lost appetite by dinnertime day after vaccination-temperature 100 degrees, dizzy, weak, felt like I had the flu. Slept most of the day. next day lethargic, no energy, some headache next day dizzy and nauseous",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PHM,"Pyridostigmine (low dose), combivent inhaler, pravastatin (15mg), estradiol patch, vitamins, NAC, biotin, lectin, Calcium",none,bronchiectasis,,bee stings,"['Asthenia', 'Body temperature increased', 'Decreased appetite', 'Dizziness', 'Headache', 'Hypersomnia', 'Influenza like illness', 'Nausea']",2,MODERNA,IM 1047103,MI,63.0,F,"""Blistery sores on the small of my back side itch and burn""; no treatment sought",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,PUB,"metformin, trulicity, pravastatin, lisinopril, aspirin, vitamin D3, omega-3 fatty acids, polyethylene glycol 400",,"HTN, class 1 obesity with serious comorbidity and BMI, Type 2 diabetes mellitus, dyslipidemia, depression with anxiety",,NKA,"['Pruritus', 'Rash', 'Rash vesicular', 'Thermal burn']",2,PFIZER\BIONTECH,IM 1047104,GA,63.0,F,"I developed a red area on my right arm to the front side of where the Pfizer vaccine was administered. The red area is about 2 inches in circumference, warm to the touch and itches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/19/2021,2.0,PUB,L-Thyroxine-50 mg; Losartan 25 mg; Aspirin- 81 mg; Vitamin D-3- 2000 IU; Glucosamine/Chondroitin-1500/1200 mg; Complete Multivitamin (Adults 50+),None,Hypertrophic Cardiomyopathy- diagnosed in 2017,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",2,PFIZER\BIONTECH,SYR 1047105,MI,66.0,F,Monday 02/15/2021 a 3 inch egg shaped rash started appearing at injection site. No pain but itched. Started as a few red pimples but became red all over and swollen (possible hives?). Later in evening swollen lymph node (about 1)2 inch diameter) under chin near left ear. Felt very tender. Lymph node swelling reduced by next morning. Rash at injection remained. Has diminished in color but is still pink thru today 02/22/2021 and no more itch. Took no action at all. Notified primary care physician Thurs 02/18/2021. Note that on Friday 02/12/2021 (prior to rash appearing) started prescription prilosec 40 mg 1 per day. Continued this thru Thurs 02/18/2021. Discontinued prilosec after speaking with primary care physician. Don't know if this had anything to do with reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/15/2021,7.0,PHM,"Vita c, lutein, acidophilus, fish oil",Occasional indigestion,None,,"Penicillin, demerol","['Acne', 'Erythema', 'Injection site rash', 'Lymphadenopathy', 'Pruritus', 'Swelling', 'Tenderness']",1,MODERNA,SYR 1047106,PA,75.0,F,One week after injection my arm around the injection site started to itch. Then it had a ring on my arm a few inches in diameter. The area felt hard and the site hurt. Still bothering me over a week later but getting better.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/18/2021,17.0,WRK,"Lisinopril, tizanidine, nortriptyline, Rosuvastatin, Zioptan, Hyoscyamine(as needed), lortadine,multi vitamin, calcium, Vitamin D,Magnesium, Zinc, B Vitamin,",No,High blood pressure,,Ibuprofen,"['Injection site discolouration', 'Injection site induration', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,SYR 1047107,NY,76.0,F,"I received my 2nd vaccine at 12:15 at the facility on Tuesday, Feb. 16. At about 10:30 that night I began to feel a bit light headed. I went to bed around 11:30 and didn't sleep very well. On Wed. am after going to the bathroom, I felt woozy while washing my hands. When I thought I felt better, I made my way back to the bedroom and passed out. I fell on my right side, bruising the right side of my face, my right hip and my right thigh. I apparently had my left hand under me when I fell because I broke the knuckle under the pinkie of my left hand.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/16/2021,15.0,PUB,"Pravastatin, 20 mg. Femara, 2.5 mg, 8 supplements from Standard Process including calcium, a probiotic, supplements to help my heart, supplements to boost my immune system, supplements to keep me calm and spplements to help my digestion.",None,None,,Compozine,"['Cast application', 'Contusion', 'Dizziness', 'Electrocardiogram', 'Fall', 'Hand fracture', 'Loss of consciousness', 'Splint application', 'X-ray of pelvis and hip']",UNK,PFIZER\BIONTECH, 1047108,MD,82.0,F,Patient was admitted for asthma exacerbation and tracheobronchitis,Not Reported,,Not Reported,Yes,6.0,Not Reported,U,02/05/2021,02/16/2021,11.0,PVT,,,"HTN, CAD, COPD, asthma",,"paclitaxel, zoledronic acid (anaphylaxis), iodinated contrast (hives)","['Asthma', 'Condition aggravated', 'Tracheobronchitis']",1,MODERNA,IM 1047109,,50.0,F,"Patient complained of upper left chest pressure, pain, and shortness of breath when walking back from bathroom after receiving 2nd dose of vaccine. Patient had been waiting in waiting area and her time was almost up. Patient's vital signs were taken by EMS and bilateral lung sounds were clear and equal. Pulses bilateral radial were normal. Patient was taken by ER in wheelchair. In ED, patient was given IV Benadryl, Solumedrol, Ativan, pepcid, and Normal Saline infusion for acute bronchospasm. Patient improved and was discharged on same day from ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,PVT,,,,,Iodinated Contrast Media- welps,"['Chest discomfort', 'Chest pain', 'Dyspnoea']",2,PFIZER\BIONTECH,IM 1047110,NY,40.0,F,"felt hot, diaphoretic, light headed",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,OTH,stelara,"arthritis, spondylosis in neck",,,none known,"['Dizziness', 'Feeling hot', 'Hyperhidrosis']",1,MODERNA,IM 1047111,FL,54.0,F,"EXTREME CHILLS AND BODY SHAKING FOR ABOUT 6 HOURS. HAD FEVER, HEADACHE AND BODY ACHE FOR 24 HOURS. VERY TIRED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,UNK,"ARMOUR THYROID, SELENIUM, VITAMIN D",NONE,HASHIMOTOS,,NONE,"['Chills', 'Fatigue', 'Fear', 'Headache', 'Pain', 'Tremor']",2,MODERNA,IM 1047112,TX,25.0,F,"3:05pm client began to complain of experiencing shortness of breath, lightheaded, dizziness, and feeling faint, she complain of feeling nausea, mouth tingling, and flush. She verbalized ""it feels like my throat is shutting"". Client diaphoretic, flush ,skin clammy, and she began to dry heave and than began to vomit. Epipen 0.3mg administered in left leg. Pulse-120 respiration-24. She said she felt like she was going to faint. EMT present and on site and quickly responded. Client transported to ER via EMS at 3:10pm",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/20/2021,0.0,SCH,Unknown,NO,Unknown,,Hyperallergic to several items,"['Cold sweat', 'Dizziness', 'Dyspnoea', 'Flushing', 'Hyperhidrosis', 'Nausea', 'Paraesthesia oral', 'Retching', 'Throat tightness', 'Vomiting']",1,MODERNA,IM 1047113,CO,84.0,F,"Patient stated she felt dizzy, but she also stated she always feels dizzy, given one Benadryl tablet, waited 30 minutes and felt fine before leaving",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,OTH,"Ativan, Losatan, Aripiprazole, Bupropion, Omeprazole, Meclizine, Gabapentin",Unknown,"Hypertension, Vertigo, Orthostatic Hypotension, Hypoxemia, Arthritis",,"Lexapro, Morphine, Remeron, Sertraline, Codeine, Penicillin",['Dizziness'],1,MODERNA,IM 1047114,MT,67.0,F,"Fever, Chills, Diarrhea, & blood Sugar drop",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Blood glucose decreased', 'Chills', 'Diarrhoea', 'Pyrexia']",2,MODERNA,IM 1047115,,74.0,F,"tired, chills and joint aches",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Arthralgia', 'Chills', 'Fatigue']",UNK,MODERNA, 1047116,TX,25.0,F,"3:05pm client began to complain of experiencing shortness of breath, lightheaded, dizziness, and feeling faint, she complain of feeling nausea, mouth tingling, and flush. She verbalized ""it feels like my throat is shutting"". Client diaphoretic, flush ,skin clammy, and she began to dry heave and than began to vomit. Epipen 0.3mg administered in left leg. Pulse-120 respiration-24. She said she felt like she was going to faint. EMT present and on site and quickly responded. Client transported to ER via Rescue Squad at 3:10pm",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/20/2021,0.0,SCH,Unknown,NO,Unknown,,Hyperallergic to several items,"['Cold sweat', 'Dizziness', 'Dyspnoea', 'Flushing', 'Hyperhidrosis', 'Nausea', 'Paraesthesia oral', 'Retching', 'Throat tightness', 'Vomiting']",1,MODERNA,IM 1047117,AL,83.0,F,"Patient had gotten Pfizer in hospital but stated she was her to get her 2nd dose of vaccine and did not have or had lost her card. She did not tell anyone that she had got Pfizer, staff found this out after questioning her further and realized it was pfizer that she received for first dose. Patient inadvertently received Moderna today as her second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,unknown,none reported,none reported,,none,['Product substitution'],2,MODERNA,IM 1047118,SC,71.0,F,"Chills, shivering, nausea, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/18/2021,0.0,PVT,"Levothyroxine, pravastatin, boniva, acidophilus, vitamin B, vitamin D",None,None,,"Darvon, iodine, gluten, chocolate, citrus, sulfites","['Chills', 'Headache', 'Nausea']",2,PFIZER\BIONTECH,SYR 1047119,NJ,57.0,M,"unusual heart Rhythm. captured on my loop recorder. early heartbeat. symptoms-, ""fluttering"" sensation in chest. tiredness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/21/2021,2.0,PVT,"Tamsulosin, Eliquis, Fenofybrate, Rasuvastatin, vitamin D, iron, vitamin C, B12",none,"Patent Foramen Ovale (Hole between upper heart chambers), Bicuspid aortic valve. Ischemic Stroke event (January 2020)",,none,"['Arrhythmia', 'Cardiac flutter', 'Condition aggravated', 'Fatigue', 'Implantable cardiac monitor insertion']",UNK,MODERNA,IM 1047120,WA,34.0,F,"The next day on 1/15/2021 around noon I felt achy, fatigue, muscle aches, headaches, & feverish. They went from mild to sever as the day continued. This symptoms stayed severed for the next 12hrs then they went mild for the next 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/15/2021,1.0,WRK,Kappra 250mg am & 500mg pm every day B12 Vitamin 1 day Vitamin D 1 a day,No,No,,No,"['Fatigue', 'Headache', 'Myalgia', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1047121,MD,49.0,F,"fatigue, nausea, loss of appetite, on side of shot pain on right side of neck all the way down to elbow. Lasted for 3 days. arm pain went away and returned 7 days later at the injection site and lasted for 3 days. arm pain started same evening as shot. Also had chills that evening only. Had itching inside right ear and right ear ringing. Fatigue, loss of appetite and nausea was present for 2 full days after the shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/11/2021,10.0,PVT,none,none,none,,minocycline allergy,"['Chills', 'Decreased appetite', 'Ear pruritus', 'Fatigue', 'Injection site pain', 'Nausea', 'Neck pain', 'Pain in extremity', 'Tinnitus']",1,MODERNA,IM 1047122,NC,74.0,F,"swollen neck, very limited head mobility (but improving), excruciating headaches; diagnosed at Emergency Department as bilateral posterior neck pain. The question I need answered is, IS IT WISE TO TAKE THE SECOND SHOT on 3/1?????",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/09/2021,5.0,OTH,"simvastatin, citalopram, multiple vitamin, Calcium, Vit D, fiber tablet and CoQ10",no illnesses. Was treated by chiropractor for TMJ,occasional problems with lower back pain and sciatica,,sulpha drugs and z pak,"['Headache', 'Laboratory test', 'Mobility decreased', 'Swelling']",1,PFIZER\BIONTECH, 1047123,TX,40.0,F,"30 minutes following, experienced a warm and flushed feeling 36 hours following injection until 72 hours: low grade fever (100.4), headache, chills 24 hours until 1.5 weeks following injection: very large swollen welt, warm to touch, painful....upon reduction of swelling looked like a bee sting as the point of puncture was still visible",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/24/2021,1.0,PVT,"Spironolactone 100mg 2x Vit-D 50,000 1xweek Trellegy Emergen-C",COVID-19 dx 12/08/20,"Asthma, high cholesterol",,Ceclor,"['Chills', 'Feeling hot', 'Flushing', 'Headache', 'Injection site pain', 'Injection site swelling', 'Pyrexia', 'Urticaria']",1,MODERNA,SYR 1047125,MA,27.0,F,Pt stated she has POTS syndrome and was feeling dizzy. Pt given 2 bottles of gatorade and monitored for additional 15 minutes. Pt tolerated fluids well and stated she felt better and was ready to leave. Walked pt to front door where fiance was meeting her. Pt denied any additional symptoms and stated if her symptom worsened she would go to the emergency room.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,SCH,unknown,unknown,POTS syndrome,,unknown,['Dizziness'],2,PFIZER\BIONTECH,IM 1047126,CA,51.0,F,"On day 5 after receiving the vaccine I developed swollen lymphnodes under my left armpit and above my left clavical bone. My neck felt and under my chin felt sore and tender. It is day 9 and I still have the swollen nodes, soreness and tender feeling in neck, shoulder and chin.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/18/2021,5.0,OTH,vitamin D Pepcid Tylenol,asthma prediabetes,prediabetes asthma,,shellfish sulfa flagyl omeprazol,"['Arthralgia', 'Lymphadenopathy', 'Neck pain', 'Pain of skin']",1,PFIZER\BIONTECH,SYR 1047127,AZ,41.0,M,"3 hours after vax Injection site soreness 15 hours after vax Fatigue 17 hours after vax elevated temp 99 degrees 21 hours after vax fever 100.3 degrees 24 hours after vax fever 101.0 degrees, chills 24 hours after vax took Tylenol 25 hours after vax fever down to 100.3 degrees (went to sleep) 34 hours after vax woke up and temp back to normal at 97.9 degrees 43 hours after vax slight headache and elevated temp to 99 degrees (went to sleep) 57 hours after vax woke up and temp back to normal at 97.7 degrees No further side effects",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/06/2021,0.0,PUB,"Truvada, Multivitamin, Vitamin D",None,"Mild asthma, elevated cholesterol",Sore arm/pain at injection site,NKA,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1047128,KY,77.0,F,"started having nausea, vomiting, abdominal pain after 2nd vaccine. Went to urgent care, then sent to ER and admitted to hospital on 2/22/21",Not Reported,,Not Reported,Yes,,Not Reported,N,02/12/2021,02/12/2021,0.0,PVT,,,,,Benzonatate,"['Abdominal pain', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram pelvis abnormal', 'Enteritis', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,IM 1047129,MD,78.0,F,"Patient admitted following a syncopal episode which was found to be likely due to dehydration, orthostatic hypotension, and post-operative pain after ORIF.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/05/2021,02/17/2021,12.0,PVT,,,"HTN, HLD, osteoporosis",,none,"['Dehydration', 'Orthostatic hypotension', 'Procedural pain', 'Syncope']",1,PFIZER\BIONTECH,IM 1047130,OH,71.0,M,"Shot given 10:10 am.. While resting at 2:20 pm became aware of ""racing heart"". Heart rate maintained 118 - 116 - 114 - 118 - 133 for about 2 hours. Then 1 hour after that it was in his normal range of 69 - 74. Patient cancelled going to work that evening at 3 pm as he did not want to be on highway with rapid heart rate. At 4 pm we had a call from our daughter who reported that a friend of hers who had covid also had this reaction after receiving her #1svaccine. Patient was covid positive in Dec and was quite ill.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,PVT,"lisinopril, omeprezole, metoprolol, zetia, atorvastatin, hctz, desipramine. flonase",,"mitral, aortic valve replacement, HTN, GERD, hyperlipidemia",,anaprox,['Palpitations'],1,PFIZER\BIONTECH,SC 1047131,OH,79.0,F,arm redness and swelling occurring ~9 days after dose administration. cleared ~ 2 days later,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/25/2021,02/03/2021,9.0,PHM,,,,,,"['Erythema', 'Peripheral swelling']",1,MODERNA,IM 1047132,FL,77.0,F,"I had usual aches and pains, I had extreme neck pain and I felt like someone kicked me in the back of the head. My head and neck and mouth and face were in excruciating pain.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/29/2021,01/30/2021,1.0,SEN,Generic Synthroid Trazadone Generic Zanex LD Naltrexone.3mg Vit D3 Viviscal,No,Fibromyalgia,,Sulfa Cytomel Prednisone Steroids,"['Cervical spinal stenosis', 'Computerised tomogram', 'Facial pain', 'Headache', 'Magnetic resonance imaging', 'Neck pain', 'Oral pain', 'Pain', 'Scan brain']",2,MODERNA,SYR 1047133,NY,58.0,F,TPA aborted Stroke on day 5 post vaccine. Probably not related but was told I needed to report it.,Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/13/2021,01/19/2021,6.0,PUB,"No prescriptions. Supplements: Vitamin D with K, Magnesium, Fish Oil",None,None,,None,"['Cerebrovascular accident', 'Computerised tomogram', 'Electrocardiogram', 'Magnetic resonance imaging', 'Procedure aborted']",1,MODERNA,SYR 1047134,,,U,"RIGHT SIDE SORENESS, FEVER, CHILLS, AND SORENESS IN OTHER BODY PARTS.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Chills', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 1047135,OR,56.0,F,"After vaccine in the waiting area, my blood sugar went up to 250 and that was after drinking water only since the night before and no food. I stayed about 1/2 hour, no one could say if this happens, About 12:30 or 1pm I wanted to sleep and slept 4 hours. The next dayi experience sensitivity to light sound headache nausea dizzy and ringing in the ears. I had to take off work at 12:30 and every since then I have had a headache after trying to work only a few hours. I couldn't keep my head set on, cant talk or train because the headaches are too bad. My doctor prescribed Imitrex. The Imitrex didn't even tough the headache, it just made me tired.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/09/2021,0.0,OTH,no,no,"Type 2 diabetes, HTN",,no,"['Blood glucose increased', 'Dizziness', 'Fatigue', 'Headache', 'Hyperacusis', 'Impaired work ability', 'Nausea', 'Photophobia', 'Somnolence', 'Tinnitus']",1,PFIZER\BIONTECH,IM 1047136,NJ,67.0,F,"Noticed blood in urine about 2 pm on day of injection (Sunday Feb 21, 2021). Also blood in urine at about 5 pm and 9 pm that day. Also the next morning at 7:30 am and 10:15 am but gone by 4 pm when I am writing this up. No pain on urination. Some discomfort inside. Had general and ob/gyn check up already scheduled for tomorrow at 8 am.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/21/2021,02/21/2021,0.0,OTH,"multivitamin, calcium w/ Vit D, Vit C, baby aspirin",none,none,,penicillin,"['Blood urine present', 'Discomfort']",1,PFIZER\BIONTECH,IM 1047137,CO,74.0,F,"Intense pain in arm, redness around arm, hard knots, skin peeled, rash had developed bumps surrounding injection site and a few ran down arm to elbow. By 2/13/21, most scabs resolved, however red bumps are still visible. She called doctor but did not go to see doctor. no treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/11/2021,9.0,PHM,"Calcium, Magnesium, Biotin, Cranberry Caps, Cinnamon Caps, Vitamin C, Vitamin D-3, Ocuvite Adult, One-a-day Adult MVI, Mega Green Tea Decaf Extract, L-Lysine, B Complex, Hawthorn Berry Extract, Beet Root Extract, Milk thistle, and prn--- St",no ongoing issues other than high blood pressure and anxiety,"High Blood pressure, anxiety",,"lisinopril, Metoprolol succinate, hydrochlorothiazide, Losartan, Amlodipine, Doxazosin, clonidine, acyclovir, penicillin, claritin, fish oil, aspirin, ibuprofen, keflex, latex","['Injection site erythema', 'Injection site nodule', 'Injection site pain', 'Injection site rash', 'Injection site swelling', 'Scab', 'Skin exfoliation']",1,MODERNA,IM 1047138,VA,68.0,F,"That evening, 2/17/21, I got home ate some soup in bed soon after, slept 10 hours! The next morning went to work and then around 9:30 the chills started, checked my temp 99.8 decided to take myself home, at took temp again, 101.7 then an hour later 102.7 where it remained for the rest of 2/18/21. By the next morning no more chills and temp 97.6. I do have a lingering headache on both sides of my head which meanders down my neck. The site of the injection is still sore and seems to have moved 3 inches down my arm. And there is also a lingering phlegm problem building up at the back of my throat.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/18/2021,1.0,PVT,Telmesartin Atorvistain Multi-vitamin Calcium with Vitamin D,None,None,,None,"['Body temperature increased', 'Chills', 'Headache', 'Impaired work ability', 'Injection site pain', 'Neck pain', 'Productive cough']",2,PFIZER\BIONTECH,SYR 1047139,DE,52.0,F,"Received vaccine on 12/30/2020: Experienced 5-7 Days of neuropathy, itching. Six hours after injection, I woke up with extreme flushing, but no fever. Worst part was, I had like a tingling and burning sensation that radiated to my extremities legs and feet. Sweating in feet that came in waves. I felt like my skin was on fire, like I was too close to a heater. Waves of numbness and tingling that was constant that lasted for approximated 5 days. Bad taste in mouth like a metallic taste. Blood pressure was extremely high. Worse at night. I went to ER on 1/3/21, because I was still having waves of burning and discomfort that was raising my blood pressure. I thought after 72 hours I would be better and it did not so this is why I went to ER. Day 5, I had lost of taste, runny nose, light nausea. By day 6, the cough turned into itchy throat discomfort. Day 7 low grade fever. Day 8, everything started to subside.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/31/2020,1.0,PVT,High dose of prednisone for adhesive tendonitis.,No,Heart Arrhythmia.,,"No. I do not take anything decongestive wise, because of heart arrhythmia.","['Ageusia', 'Burning sensation', 'Cough', 'Discomfort', 'Dysgeusia', 'Flushing', 'Hyperhidrosis', 'Hypertension', 'Hypoaesthesia', 'Influenza A virus test negative', 'Influenza B virus test', 'Nausea', 'Neuropathy peripheral', 'Paraesthesia', 'Pruritus', 'Pyrexia', 'Rhinorrhoea', 'SARS-CoV-2 test negative', 'Skin burning sensation', 'Throat irritation']",UNK,MODERNA,IM 1047140,NJ,52.0,F,2.5 hours after the vaccine given in my left arm - My right face and neck (jaw line) started to swell up with some pain to touch. My hearing was effected as my right ear felt like it had a cotton ball in it. I immediately knew it was an allergic reaction to the vaccine injection. I presented to the Emergency Room @ 2:40 pm. I was seen my Dr. I was given 10 mg of steriod and Benadryl. I was evaluated for 3 hours and discharged with Diphenydramine 25 mg script. The swelling decreased 2 days later.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PHM,NONE,NONE,NONE,,NONE KNOWN,"['Ear discomfort', 'Hypoacusis', 'Pain of skin', 'Swelling face']",2,MODERNA, 1047142,MT,26.0,F,"Headache, Nausea, Fever, & Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Chills', 'Headache', 'Nausea', 'Pyrexia']",2,MODERNA,IM 1047143,GA,71.0,M,Following day I had a low grade fever and moderate fatigue.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/21/2021,3.0,PVT,"Eliquis 5mg, Atorvastatin 40 mg, Metoprolol 25 mg, Advir inhaler 20, Asprin 80 mg, fish oil 500 mg, Perservision multi vitamin, Elderberry.",none,Coronary artery disease,,none,"['Fatigue', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1047144,WY,74.0,F,Client reported difficulty breathing after receiving her vaccine. She received her shot in an offsite drive through clinic. Epi was administered by EMS and she was transported to Medical Center. She reports she was released later that day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,PUB,Several per patient,,,,"Penicillin, 'many foods', blue, purple and green dye",['Dyspnoea'],1,MODERNA,IM 1047145,WV,36.0,F,"Red face/neck, hives and itching to body, starting att approx 3:40 then throat felt raw and Benadryl 50mg was administered IM.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,OTH,"Linzess, Allegra, Estradiol, Singulair","IC, IBS with constipation, seasonal allergies, treated with Solumedrol 125 and Ketorolac 60 injections 2/18 due to possible carpal tunnel to right wrist.","IC, IBS with constipation, seasonal allergies",,Contact allergies to bleach and eggs,"['Erythema', 'Pruritus', 'Throat irritation', 'Urticaria']",1,MODERNA,IM 1047146,WA,53.0,F,"Day 1-slightly swollen tender lump, two small red patches, warm to touch, sleepy. Day 2-same as above. Headache for entire day, and sleepy. Day 3- Arm still tender (frogged feeling) Day 4-6 Feeling ok Day 7 Itchy, icy feeling on arm. Feeling uncomfortable. I am considering taking an antihistamine Claritin, as I don?t want to scratch it. I have a faint large circle around shot. It isn?t red, as I have resisted scratching it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/22/2021,7.0,PHM,None,Rosacea,"Arthritis, rosacea",,Caffeine,"['Discomfort', 'Fatigue', 'Headache', 'Injection site reaction', 'Mass', 'Pruritus', 'Rash macular', 'Skin warm', 'Somnolence', 'Swelling', 'Tenderness']",1,MODERNA,SYR 1047147,PA,84.0,F,"Patient developed erythema that started on 2/20/21 just below the vaccine site about 2 weeks after vaccination. There is no respiratory difficulty and it got wider today and a little itchy and red. There are no rashes and no signs of anaphylaxis, no GI symptoms. She also had EMG done on both upper extremities prior to this starting. I advised her to use cold compress and local / topical 1% hydrocortisone on it. To contact us if symptoms worsen and to the ER if any worsening symptoms or respiratory compromise.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/08/2021,0.0,PUB,Patient developed erythema that started on 2/20/21 just below the vaccine site about 2 weeks after vaccination. There is no respiratory difficulty and it got wider today and a little itchy and red,Routine medical problems though just had EMG done,"Hypertension, hypothyroidism, hyperlipidemia, DJD",,seasonal allergies,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 1047149,AZ,72.0,F,"Felt flush and had hives to arms and chest. Hypertensive at 220/132. Denies any difficulty breathing. Negative edema to mouth, face or throat. IV established and 50mg Benadryl given through IV. Transported to hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/04/2021,0.0,PUB,"HCTZ, simvastatin, metformin, levothyroxine",slight fever and fatigue over one week ago. Had a negative COVID test.,"Diabetic, thyroid, high cholesterol",,penicillin,"['Flushing', 'Hypertension', 'Urticaria']",1,MODERNA,IM 1047150,FL,69.0,F,"I'm 69 and never really had but a few random minor hot flashes when I experienced menopause at age 50. However, it isn't on the list of side effects but I've had hot flashes every few hours since about and 2 hours after my first dose injection. For the most part they are mild but come on every 1 to 4 hours while I'm awake. I had a terrible one like I'd never had before where I was soaked through my clothes almost exactly 24 hours after the shot the following day. They are still occurring now 72 hours after the shot. they are mostly bothersome and will hopefully subside in the next few days. Other than that I only had the normal local tenderness on my arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,PUB,Famotidine 40mg 2x/day Enalapril 10mg 2x/day B12 1000mcg 1x/day D3 50mcg/2000IU 1x/day Spiriva inhaler 2.5mcg 2 puffs-1x/day Flovent inhaler 110mcg 2 puffs-2x/day,None,Mild COPD Obesity - but not morbid Hypertension Gastroparesis - mild,,Allergy to Celebrex Allergy to all 3 dust mites (GI intolerance to all NSAIDs),"['Hot flush', 'Pain of skin']",1,PFIZER\BIONTECH,SYR 1047151,,43.0,M,Patient was diagnosed with COVID 19 on 16 Feb. 11 Days after first vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/16/2021,11.0,MIL,,None,,,None,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1047152,OH,55.0,F,"Cold sweating, lethargy, nausea and vomiting , swollen lymph nodes under left arm. Lasting a little over 48 hours. Lymph nodes under left arm are still slightly swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,OTH,"Enalapril, Simvastatin, Peroxitene",,,,,"['Cold sweat', 'Lethargy', 'Lymphadenopathy', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 1047153,CA,31.0,F,Jaw became numb x 5 days. Denies pain of any kind.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,PVT,none,"Recovering from COVID, onset cleared on 1/4/2021 to return to work.",none,,PCN,['Hypoaesthesia'],2,PFIZER\BIONTECH,IM 1047154,MA,75.0,F,"A week after injection, on evening of 2/10, I noticed a large red rash, very warm at vaccination site. I called Dr. next morning and saw her that afternoon on 2/11. She told me it was a reaction to the vaccine, and put me on antibiotics for 7 days. She traced the area with a pen, and told me to watch it. If it got worse and spread a lot, I was to go to the hospital, as their office would be closed over the weekend. I started the antibiotics that day, and it has gotten better, but not completed resolved. It did spread slightly, but not enough to be concerned.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/17/2021,8.0,OTH,"Levoxyl, Zyrtec, Vit C, D=3 , E. Eye drops - Prednisolone, Combigan, Azopt, Ketorolac, Ropressa",Sinus Infection prior,,,"Tetracycline, Erythamycin, Skelaxin, Cipro, Keneflex creme","['Vaccination site rash', 'Vaccination site reaction', 'Vaccination site warmth']",1,MODERNA,SYR 1047155,NC,38.0,F,"Pt complained of extremity feeling warm internally, itching, and numbness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PUB,,,,,,"['Feeling hot', 'Hypoaesthesia', 'Pruritus']",UNK,PFIZER\BIONTECH,IM 1047156,AL,40.0,F,"Patient received 2nd dose of Moderna Covid vaccine at approximately 9:00am. 15 minutes later she started to feel dizzy and complained of chest pressure. She then experienced a syncopal episode with lasted approximately 45 seconds. This patient has not experienced a previous allergic reaction to the first dose. She developed an itchy red rash on her right and left arms. She also reported nausea. In the emergency department, she received Solu-Medrol 80mg, Benadryl 25mg, 1L of NS fluid, Pepcid 20mg, and Zofran 4mg. She was discharged to home via wheelchair once stable. At the time she was discharged, patient was awake, alert, and oriented x3. Patient verbalized understanding of disposition. She was given prescriptions for promethazine 25mg and ondansetron 4mg.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PVT,None.,None.,Hypertensive disorder,,No known allergies,"['Chest discomfort', 'Dizziness', 'Nausea', 'Rash', 'Rash erythematous', 'Syncope']",2,MODERNA,IM 1047157,MN,28.0,F,"Miscarriage at 8 weeks of pregnancy, 2/14/21. Tissue passed naturally without medical intervention. Hormone levels dropped without concern. The week prior to miscarriage sharp sporadic headaches (migraine-like but only lasting a few minutes at a time and coming frequently) started, and have continued daily through today (2/22/21)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,02/14/2021,20.0,SEN,Prenatal vitamins with omega 3; vitamin d3,N/a,Digestive issues related to previous gastritis/stress,,N/a,"['Abortion spontaneous', 'Exposure during pregnancy', 'Human chorionic gonadotropin decreased', 'Migraine']",2,MODERNA,IM 1047158,MD,81.0,F,"Usual sore and painful arm day after vaccination. But then an unusual reaction for me. About the 7th day after the vaccination, an itchy red rash about 3 inches developed around the vaccination site with a moderate amount of swelling continuing. Still have it today on the 11th day after first dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/19/2021,8.0,PUB,"amlodipine, gabapentin, citalopram, melatonin",none,seasonal allergies,,biaxin,"['Injection site pruritus', 'Rash erythematous', 'Vaccination site pain', 'Vaccination site rash', 'Vaccination site swelling']",UNK,MODERNA,IM 1047159,MO,91.0,M,"We arrived on 02/10/2021 to give second doses to residents. Upon arrival we were told several had contracted COVID-19 after their first immunization. Upon reviewing their records, it had been greater than 14 days of recovery, per agency recommendations, they should have received their second doses. The director of nursing and the facility physician however told us we were not to vaccinate the residents until 30 days from their last negative test. After discussing guidelines and recommendations they would not change their minds. This is 1 of 18 patients that did not receive their second dose in the 6-week window at this facility.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/13/2021,01/01/2021,,PHM,,,,,,['Inappropriate schedule of product administration'],1,MODERNA,IM 1047160,IL,36.0,F,"LEFT ARM SORENESS, RAPID HEARTBEAT, TIGHTNESS IN CHEST, AND CHILLS.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/19/2021,01/20/2021,1.0,OTH,,,,,,"['Chest discomfort', 'Chills', 'Heart rate increased', 'Pain in extremity']",1,MODERNA,IM 1047161,AS,68.0,F,"Started getting some burning around the left eye & nose.Same area I had shingles 10 years ago. By Monday left eye swollen shut. Saw opthmologist prescribed Acyclovir. Over a couple days swelling dissapeared and burning, itching subsided. The thing is, I had my second COVID dose on 02/10/2021, 10:00AM Pitzer Lot #9581. On 02/18/2021 late evening, started to feel burning in left eye nose area again, next morning eye swollen shut. Saw Dr, said I was having an allergic reaction and put me on prednesone and Amoxicylin. No reduction of swelling and burning, blisters were forming. Went to Urgent Care on 2/20/2021 and was prescribed Acyclovir again. Swelling now gone and itching burning diminished.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/30/2021,10.0,OTH,"pregabalan, bupropion, fluoxetine, meloxicam, symbacort,lisino",none,"pollen allergies, dust mite allergies, lack of breath. Post herpatic neuralgia. High cholesterol, high blood pressure",,Sulfa based anitbiotics,"['Blister', 'Burning sensation', 'Drug hypersensitivity', 'Eye irritation', 'Eye swelling', 'Pruritus']",UNK,PFIZER\BIONTECH,IM 1047162,AZ,40.0,F,Patient felt lightheaded and was unable to stand without assistance. Was hypotensive. IV established and fluid administered IV. Transported to medical center via ambulance.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/04/2021,0.0,PUB,"Hydroxizine, diet supplements",None,Anxiety,,Morphine,"['Dizziness', 'Dysstasia', 'Hypotension']",1,MODERNA,IM 1047164,CA,58.0,F,Fever headache no energy body aches nausea fatigue muscle aches,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/20/2021,1.0,UNK,,,,,,"['Asthenia', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,SYR 1047165,TX,56.0,M,Developed Shingles 5 days after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/20/2021,5.0,PVT,Enbrel,,"psoriatic arthritis, chronic kidney disease",,,['Herpes zoster'],1,MODERNA,IM 1047166,KY,47.0,F,Received 2nd vaccine on 2/19/21 and started having fatigue the next day that progressed into Chest pain that radiates into shoulders.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/22/2021,3.0,PVT,,,"COPD,",,NKA,"['Arthralgia', 'Chest X-ray normal', 'Chest pain', 'Electrocardiogram normal', 'Fatigue', 'Pain']",2,PFIZER\BIONTECH,IM 1047167,MO,62.0,F,"We arrived on 02/10/2021 to give second doses to residents. Upon arrival we were told several had contracted COVID-19 after their first immunization. Upon reviewing their records, it had been greater than 14 days of recovery, per CDC recommendations, they should have received their second doses. The director of nursing and the facility physician however told us we were not to vaccinate the residents until 30 days from their last negative test. After discussing guidelines and recommendations they would not change their minds. This is 1 of 18 patients that did not receive their second dose in the 6-week window at this facility.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/13/2021,01/01/2021,,PHM,,,,,,['Inappropriate schedule of product administration'],1,MODERNA,IM 1047168,MT,36.0,F,Body aches and upset stomach,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Abdominal discomfort', 'Pain']",2,MODERNA,IM 1047169,TX,83.0,F,"jaundice->hemolytic anemia-> hemorrhagic shock->multi organ failure->death pt admitted to ICU 2/16 with Hgb=3.4, treated with steroids, supportive care , pressors, pt died 2/20/21",Yes,02/20/2021,Not Reported,Yes,4.0,Not Reported,N,02/06/2021,02/13/2021,7.0,UNK,risedronate 35 mg po q week levothyroxine 25 mcg po daily lipitor 10 mg po daily azelastine nasal spray 2 sprays nasally as needed,none,"mild anemia hypothyroid ""prediabetic"" dyslipidemia macular degeneration",,NKA,"['Death', 'Haemoglobin decreased', 'Haemolytic anaemia', 'Haemorrhagic stroke', 'Intensive care', 'Jaundice', 'Multiple organ dysfunction syndrome', 'Platelet count decreased', 'Shock haemorrhagic']",1,MODERNA,IM 1047170,UT,70.0,M,"On January 28 around 9 am, I started feeling sick. About an hour later, I felt nauseated and then started vomiting. I vomited throughout the day, about 6 times. I assumed this was a fairly common reaction to the vaccine. The following day (Jan. 29) I felt very weak and noticed that when I signed my name, my hand felt numb and I couldn't control it very well. On Saturday, my left leg began to feel abnormal. I called a friend who is a retired doctor and he said that he had heard of some neurological reactions to the vaccine. By Sunday, I was having a difficult time walking so I called my GPs office and set up an appointment for Monday morning. As soon as she saw my face without a mask, she said that I had had a stroke. I had a slight droop on my left cheek and mouth which indicated to the doctor that a stroke had occurred. She scheduled me for a MRI the following morning, Feb. 3. As soon as the MRI was completed, my GP scheduled me with a neurosurgeon whom I was able to see the same afternoon. The diagnosis was a right medullary ischemic stroke. She ordered a number of tests to be run and scheduled me for March 9 to come back for the result of all the tests and blood work. Doctor referred me for physical therapy to help me regain the use of my left leg and hand.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/27/2021,01/28/2021,1.0,OTH,"Simvastatin 40 mg, amLODIPone BESYLATE 2.5 mg, Lisinopril 40 M, low dose aspirin",,"High blood pressure, high cholesterol",,,"['Angiogram', 'Asthenia', 'Blood test', 'Cardiac monitoring', 'Echocardiogram', 'Facial paralysis', 'Gait disturbance', 'Hypoaesthesia', 'Ischaemic stroke', 'Laboratory test', 'Magnetic resonance imaging brain abnormal', 'Malaise', 'Motor dysfunction', 'Nausea', 'Sensory disturbance', 'Vomiting']",1,PFIZER\BIONTECH,IM 1047171,MN,48.0,F,"I received the vaccine on February 6th. My arm was sore for about 5 days. The soreness went away. On February 16th, I noticed a red itchy spot where I had the vaccine. On the 17th, the red itchy spot grew larger. It was slightly swollen, red, warm to touch, and pinkish. I did a video conference with a doctor. She said it could be a delayed reaction to the vaccine or cellulitis. I was prescribed CLEOCIN (Take 3 capsules by mouth three times a day for 7 days). It continued to swell and spread on 18th and 19th. I saw another doctor on the 19th. She prescribed predniSONE for three days and BACTRIM DS for 10 days. She mentioned it could be a reaction to the vaccine or cellulitis. I am concerned about getting the 2nd vaccine on March 6th. I won't be done with the meds until March 1st. As of Monday, February 22nd, the spot is not longer swollen. It is slightly pink and much smaller.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/16/2021,10.0,PVT,Albuterol desogestrel-ethinyl estradiol daily vitamin Advair Zyrtec Singular pramipexole probiotic,None,asthma,,penicillin - rash and hives Cefprozil - rash and hives,"['Cellulitis', 'Erythema', 'Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Pain in extremity', 'Skin warm', 'Swelling']",1,MODERNA,SYR 1047172,SC,74.0,F,2/22/21 patient reports that the next day after her injection her throat and the inside of her mouth felt tight. She had body aches and had not energy. Today she reports that her lips and inside of mouth still feel numb. Patient wondered what she should do about her next injection. This was reported to CNP and she advised that patient does not receive the second dose of the COVID vaccine as scheduled. Continue to observe and report any new findings. Patient was called with instructions from CNP,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/18/2021,1.0,PVT,See attached sheet,Had ( L) glenohumeral intra-articular steroid injection 1/27/2,"CVA, COPD,CAD,CABGx3,HTN,HLP,Hypothyroidism,hx of breast CA",,Benadryl,"['Asthenia', 'Hypoaesthesia oral', 'Pain', 'Throat tightness']",1,MODERNA,IM 1047173,IN,80.0,F,"BOTH SHOULDERS HURT. HEAD AND BODY FELT HEAVY COULD NOT GET UP. LEFT ARM SWOLLEN, RED AND PAINFUL FOR 5 DAYS",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,PUB,AMANTADINE 100 MG CITRIZINE 10 MG OMEPRAZOL,NONE,,,LATEX,"['Arthralgia', 'Discomfort', 'Dysstasia', 'Erythema', 'Head discomfort', 'Pain in extremity', 'Peripheral swelling']",2,MODERNA,IM 1047174,IL,24.0,F,"The next day after receiving the vaccine I noticed the band aid over the injection site was wet, so I removed the band aid and there was a small (pencil eraser size) area of desquamated skin with clear liquid coming out. Over the next day it developed into a blister that did not rupture, and is now a dark red slightly raised area with scabbing/crusting around the edges. It is mildly pruritic but otherwise not bothersome",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,PVT,Completed Metronidazole 2 days prior to vaccine. Was not taking anything during the vaccine. Pt. uses NuvaRing and had ring in during vaccination,"Fever, chills, headache, and heart burn for 24 hours after first dose of vaccine (1/22/21).",None,,None,"['Injection site discharge', 'Injection site erythema', 'Injection site exfoliation', 'Injection site pruritus', 'Injection site scab', 'Injection site swelling', 'Injection site vesicles']",2,MODERNA,IM 1047175,MA,70.0,M,Intermittent dizziness.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,PUB,"Avorstatin, Baby Aspirin, Multi Vitamin. Vitamin D3",None,None,,None,['Dizziness'],1,MODERNA,IM 1047176,LA,83.0,M,"On Friday morning, February 19 around 9 am, patient felt like he was biting his lip but didn't say/do anything about it. He got up and got dressed, went about his day. Around 12:30 his nephew saw him and commented that his left eye was puffy and red, his face was swollen and drooped and he looked like he was having an allergic reaction of some kind. At that time, his speech became slurred. They got a neighbor, who is a nurse, to come over. She recommended medical attention. They went to an urgent care center and were immediately sent to the hospital.. Left side of his face was drooping and his speech was slurred. There were no cognitive issues. Arrived at hospital around 1:30. He was assessed immediately for a stroke and it was determined that he had not had a stroke. Bell's Palsy was diagnosed. He was given a steroid injection at the hospital and given a Medrol dosepak to begin on Saturday, Feb. 20 and sent home. As of today, Monday, February 22, his symptoms are improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/27/2021,02/19/2021,23.0,PHM,"finasteride, oxybutynin, famotidine (prn), lovastatin, super vitamin B complex, Bayer Aspirin 325 mg, ibuprofen",none,"high cholesterol, trouble with urinary flow, gastritis occasionally",,"no drug allergies, no food allergies, no other allergies","['Chest X-ray', 'Computerised tomogram head normal', 'Dysarthria', 'Echocardiogram', 'Electrocardiogram', 'Facial paralysis', 'Hypersensitivity', 'Laboratory test', 'Lip pain', 'Ocular hyperaemia', 'Periorbital swelling', 'Swelling face', 'Ultrasound Doppler']",1,MODERNA,IM 1047177,NC,77.0,F,"patient c/o lightheadness at 11:55am. Blood pressure was 142/90. Consulted with Doctor. observed for 10 more minutes. Patient started c/o numbness in face, shortness of breath and chest pain around 12:05pm. 02 was 99%. Consulted with Doctor and paramedics called. Patient was confused and had difficulty with balance while being transferred to ambulance. Transported to medical Center at 12:18pm",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/13/2021,0.0,PUB,baby Aspirin,unknown,"Hypertention, prediabetes",,none listed,"['Balance disorder', 'Chest pain', 'Confusional state', 'Dizziness', 'Dyspnoea', 'Hypoaesthesia']",2,PFIZER\BIONTECH,IM 1047178,NM,64.0,F,"One week after receiving my first Moderna vaccine, I developed a rash and swelling at the injection site. The rash was about 6-8 inches across, and slightly itchy. The site is swollen and warm to the touch. I've had the rash now for 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,PHM,Fluoxetine Hcl Tabs 10 Mg Multivitamin Calcium/magnesium supplement,,asthma,,"Penicillen food sensitivities: dairy, egg, wheat","['Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Rash pruritic']",1,MODERNA,IM 1047179,MT,28.0,F,Body aches & Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Headache', 'Pain']",2,MODERNA,IM 1047180,MS,45.0,F,"OUTER SIDE OF RIGHT FOOT AND 3RD AND 5TH DIGIT ARE BLUISH/PURPLE, THEN RED, SWOLLEN AND PAINFUL. NO OTHER EXPLANATION FOUND FOR THIS ISSUE",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,02/08/2021,25.0,PVT,"XIGDUO, METOPROLOL, LOSARTAN, OZEMPIC, ZETIA",NONE,"DIABETES, HEART DISEASE, HYPERTENSION, HYPERLIPIDEMIA",,NKA,"['Erythema', 'Laboratory test', 'Pain in extremity', 'Peripheral swelling', 'Skin discolouration']",1,MODERNA,IM 1047181,TX,82.0,F,Hospitalized for possible TIA or stroke or maybe Guillain Barre syndrome,Not Reported,,Not Reported,Yes,5.0,Not Reported,U,02/12/2021,02/12/2021,0.0,PHM,Valsartan/HCTZ 160mg/25mg Gemfibrozil 600 mg,,blood pressure,,,['Unevaluable event'],1,MODERNA,IM 1047182,CT,71.0,M,"pt states the next day after he got the covid vax that he wasnt feeling well, he didnt feel right, foggy headed, felt disoriented and confused. He couldnt put words together to make a sentence. He got up to go into the kitchen and then urinated all over himself. He was worried about falling sleep, scared he would die in his sleep. The 3rd woke up and was feeling some better but still foggy headed. Pt went to the ER about 5 days later. They did a CT and blood work. He thinks the tests results came back negative. They wanted him to stay longer and maybe see a Neurologist but since there wasnt one available to see at that time the pt decided to go home. He has blood work and urine labs to be done at the facility on 2/23/2021. Pt states he is feeling better at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/12/2021,1.0,MIL,"probiotic 10, acetophetomine325 x4 daily, apixaban 5mg x1 every 12 hrs, folic acid 1mg, fluconazole 200mg x2 every 12 hrs, buprenorphine 8mg x 3 daily, simvastatin 40 mg, metoprolol 50mg 1 1/2 tab x2 daily, gabapentin 300mg 3 tabs x 3 dail",no,"Spinal stenosis,",flu shots- in the past he used to get flu like symptoms but not any longer,Nsaids,"['Anxiety', 'Blood test', 'Computerised tomogram', 'Confusional state', 'Disorientation', 'Fear of death', 'Feeling abnormal', 'Malaise', 'Sleep deficit', 'Speech disorder', 'Urinary incontinence']",1,MODERNA,IM 1047183,MO,82.0,F,Pt had expired before second dose was delivered.,Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,,01/14/2021,01/01/2021,,PHM,,,,,,['Death'],2,MODERNA,IM 1047184,CA,44.0,F,"1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat. 75mg Benadryl taken orally. - 1 hour later dizziness, heart rate 44, lost voice, face looked swollen. - 5 hours after vaccine administered went to outpatient clinic, heart rate 48 there. - After 1 hour, heart rate 120, sweaty, dyspnea and went to Emergency Room. 1/27/21-Amitted to Hospital -Given Solumedrol, Benadryl and Pepcid. Slowly improved. 1/29/21-Discharged Home on Pepcid 20mg BID x15 Days and PRN Benadryl. 2/8/21-Returned to work, but still has to take Benadryl daily for rash and uses Albuterol inhaler intermittently for ""tightness"" in throat.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/27/2021,01/27/2021,0.0,WRK,"Levothyroxin, Ibuprofen, Tylenol",None,"Hypothyriod, well treated and controlled.",,"Penicillin, Sulfa, Bactrim, Codeine, Shell Fish","['Aphonia', 'Dizziness', 'Dyspnoea', 'Hyperhidrosis', 'Laboratory test normal', 'Rash', 'Swelling face', 'Throat irritation', 'Throat tightness', 'X-ray']",2,PFIZER\BIONTECH,IM 1047185,NY,75.0,F,"Site of vaccination began itching about one week after injection. A red area surrounding the injection site was noted about 3 days later. Itching is insignificant, and the arm is otherwise completely normal. Since it is now about 10 days after the injection, I don't know how long it will take before the rash disappears.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,PVT,,,,"Shingles, second dose, mild fever the day following the injection.",,"['Injection site erythema', 'Injection site pruritus', 'Rash']",1,MODERNA,IM 1047186,WA,77.0,F,"Problem # 1: Allergic contact dermatitis (ICD-692.9) (ICD10-L23.9) Diffuse erythematous plaque-like allergic appearing rash on face trunk arms and scalp. Timeline suggest it is a reaction to her second Covid vaccine injection. Only other new exposure was going to be pewter day prior to symptoms and eating popcorn but she has had this in the past with no problems Suggest we stated before that this is a reaction to Moderna Covid vaccine I would suggest she not get it in the future if able to We will treat with oral prednisone and continue antihistamines. Also use ice packs , oatmeal baths and calamine to help with itching She will call or portal if symptoms or not improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/21/2021,3.0,PVT,1) Efudex 5 % External Cream (Fluorouracil) .... apply thin layer to sun damaged lesion once daily for 2-4 weeks. wash hands after use 2) Atorvastatin Calcium 40 Mg Oral Tablet (Atorvastatin Calcium) .... Take 1 tablet by mouth daily for ch,none,hypothyroid high cholesterol osteoporosis hx of breast cancer Anxiety,,,"['Dermatitis allergic', 'Dermatitis contact', 'Pruritus', 'Rash', 'Rash erythematous']",2,MODERNA,IM 1047187,CA,63.0,F,"Patient complained of tingling sensation of the mouth and tongue, no numbness, sensation remains intact., not in respiratory distress, able to respond verbally. Patient stated that she also experienced tingling on f the mouth and tongue and pain on lower back after her first dose, but resolved after 15 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,"Atenolol, Metformin","DM 2, Hypertension","DM 2, Hypertension",,None,"['Back pain', 'Paraesthesia oral']",2,PFIZER\BIONTECH,IM 1047188,,71.0,F,Day 7 post COVID shot she got redness around injections site and very itchy,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/19/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus']",UNK,MODERNA, 1047189,TX,37.0,F,"Fever, chills, body pain, headache and mild rash on the chest and back. took Advil every 8 hours. rash disappeared after 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/28/2021,1.0,UNK,Excedrin Migraine. Omega-3 .,,Psoriasis. Hypertension. pre diabetic.,,"rash with antibiotics like Amoxicillin, rash with peanut butter .","['Chills', 'Headache', 'Pain', 'Pyrexia', 'Rash']",1,MODERNA,IM 1047190,AZ,48.0,F,Felt as though she was having an asthma attack. Used her own inhaler with relief. Has clear lung sounds and oxygen sat. is good. Has minor swelling to both hands which she sts she had with the first COVID vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,PUB,"Synthroid, albuterol, singular",,"POTS, asthma, thyroid, celiac",swelling to hands with first COVID vaccine and has reaction to flu. Unknown what happen with flu vaccine.,"artichokes, latex, chemical allergies, adhesives","['Asthma', 'Peripheral swelling']",2,MODERNA,IM 1047191,NJ,33.0,F,"For about 8 hours on the day after I received the second shot, I experienced sweats (no chills) and (possibly) a fever. I felt slightly achy and tired. I did not have pain at the injection site or any difficulty lifting my arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,MIL,"No pregnancy complications, due 3/23/21",,Beta-thalassemia carrier/minor,Flu Shots make me feel feverish and achy the next day.,,"['Fatigue', 'Hyperhidrosis', 'Pain']",2,PFIZER\BIONTECH,IM 1047192,MO,82.0,F,Pt refused second dose of vaccine. She cited adverse effects but couldnt not provide specific details.....,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/14/2021,02/01/2021,18.0,PHM,,,,,,"['Refusal of vaccination', 'Vaccination complication']",2,MODERNA,IM 1047194,NJ,52.0,F,"ed in ER: given predisone and breathing treatment and was was released at 1:36 pm. Was given an Rx to take 50 MG of Prevacid to take 1x a day for 5 days. Saturday: 2/20/2021 -- Took 50 mg of prevacid at 9 am and 10 mg of pepcid 4:50 pm. Eyes swelled, lump in throat Went to ER Was admitted for observation at hospital. Received predisone and benedryl through IV 1:30 bottom lip started to swell was given 25 mg of benadryl by mouth Around 7:30 am scalp started to itch - Was given 20 mg of predisone orally Around 9 am rash on face was given 50 mg of benadryl Around 2:30 pm Doctor came into room because my throat felt tight. She looked at it and said ""its not too bad."" She had the nurse give me benadryl via interveniously Was discharged around 3:30 pm on Sunday, February 21, 2021 Monday: 2/22/2021 Around 1:15 pm felt lump in throat, felt like my neck was swollen, took 25 mg of benadryl. Called Doctor. Took another 25 mg of Benadryl. Still didn't feel right. Went over to Dr office, my asthma and allergy doctor. At Dr office, I was given two injections of medication. (He told me what it was, but I cant recall the names.) He sent me home with the following instructions: zyretc 10 mg am and pm bendryl 25 mg every 4 hours as needed pepcid 20 mg am and pm predisone 20 mg 3x1 day tomorrow take 20 mg of predisone I am to call his office after 1 pm tomorrow 2/23/2021 to give status report on how I am doing",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/19/2021,02/22/2021,3.0,OTH,"zyrtec, multi vitamins, rhinocort",No active illness. Was healthy at the time,Asthma - only take prn meds when it flares up,,"sulfur, flagyl,","['Eye swelling', 'Feeling abnormal', 'Lip swelling', 'Pruritus', 'Rash', 'Sensation of foreign body', 'Swelling', 'Throat tightness']",1,PFIZER\BIONTECH,IM 1047195,TN,69.0,F,"Covid arm Itchy, rash, a little swollen and warm Almost a cramping like pain in thigh muscle and bicep, which came and went for three days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/17/2021,9.0,UNK,Zyrtec d,No,,,None,"['Myalgia', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Rash', 'Skin warm']",UNK,MODERNA, 1047196,MA,81.0,F,"Rash,itch, swelling. Headache, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/21/2021,11.0,PUB,"Lisinoprile, Hydro, Amlodipine, omeprosole.",none,High Blood Pressure,,Sulfur drugs,"['Fatigue', 'Headache', 'Pruritus', 'Rash', 'Swelling']",1,MODERNA, 1047197,KS,84.0,M,death,Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/20/2021,8.0,PHM,"Morphine concentrate, Lorazepam Intensol, Clopidogrel, Vitamin D2, Tamsulosin, Amlodipine, Atovastatin",Pt on hospice,,,NKDA,['Death'],1,MODERNA,IM 1047198,FL,77.0,F,swelling hard red itching and burning at the site. 10 days after injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,OTH,thyroid meds,none,none,,none,"['Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 1047199,NY,73.0,M,"First dose received 01/22/2021 and second dose on above date (02/11/2021) These events may have no relation to the vaccination but due to their concomitance, I eventually felt it might be best to report them. Three days following the first dose, I started to experience hematuria as well as constipation. It has happened before as a result of radiation treatment back in 2005/2006. Saw my urologist on 02/02/2021, and had several tests, ruling out any return of cancer. Antibiotics improved the situation, which was getting closer to normal prior to getting the second dose. Again, three days following the second dose, hematuria returned and still prevails at various degrees. Also experience fatigue and weight loss.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/12/2021,1.0,PVT,,Glaucoma,Diabetes and post-cancer treatment side effects,,Alphagan drops,"['Computerised tomogram', 'Constipation', 'Cystoscopy', 'Fatigue', 'Haematuria', 'Urine analysis', 'Weight decreased']",2,PFIZER\BIONTECH,SYR 1047200,OR,40.0,M,Patient had breakthrough seizure on 2/5/2021. Last prior seizure was 5/2020 before starting Keppra. It is not clear if seizure was related to vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,02/05/2021,23.0,UNK,"Hydroxychloroquine, keppra, fenofibrate, aspirin","Chronic lupus, seizure disorder, hypertriglyceridemia","Chronic lupus, seizure disorder, hypertriglyceridemia, history of stroke",,NKDA,['Seizure'],1,MODERNA,IM 1047201,KS,35.0,F,Rash and itchiness within 30 minute waiting period,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,,,,,"Penicillin, Sulfa, Cipro, Cephalaxin","['Pruritus', 'Rash']",2,PFIZER\BIONTECH, 1047202,OH,75.0,F,"About 11 am I was masked in church and developed a tickle in my throat. I cleared my throat to no relief. I took 2 cough drops. About 11:30 I got a bottle of water. No relief after drinking 8 ounces. I left the service, went outside, removed my mask and was coughing forcibly for about 15 minutes or so. Expectorated clear phlegm 6 - 8 times. Gradually I settled to normal. Just some residual soreness in throat. This was an unusual occurrence for me. I was covid positive in early Dec, but had a very mild case. Back in the 70's I would have reaction to allergy shots. I waited in the office 15 minutes, but 45 minutes later when I arrived home I had huge hives and severe itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,PVT,"Diltazem CD, pravastatin, fenobibrate, chlortrimeton, EC aspirin, MVI, calcium",,"SVT, hyperlipidemia",,"PCN, Norco, codiene, phenergan, Darvon. mild latex, seasonal, sole, flounder","['Angioedema', 'Cough', 'Oropharyngeal pain', 'Pharyngeal paraesthesia', 'Productive cough', 'Throat clearing']",1,PFIZER\BIONTECH,SC 1047203,AR,44.0,F,"Intermittent Loss of taste, rash, body aches, muscle aches, sore throat, tiredness, weakness, migraine, shortness of breath, ear pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,OTH,"Lisinopril, adavan, lamotrogine, metropolol, trazodone",None,High blood pressure,,"Codeine, hydrocodone, tramodol","['Ageusia', 'Asthenia', 'Dyspnoea', 'Ear pain', 'Fatigue', 'Migraine', 'Myalgia', 'Oropharyngeal pain', 'Pain', 'Rash']",2,PFIZER\BIONTECH,SYR 1047204,ME,73.0,F,Acute thalamic cerebrovascular event,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,PVT,"Fish oil, gabapentin, glipizide, HCTZ, losartan, metformin, metoprolol, aspirin, oxybutynin, tramadol, Tresiba, venlafaxine",none,"Type II diabetes, depression/anxiety, hypertension, dyslipidemia, overactive bladder, osteoarthritis, diabetic neuropathy",,"Januvia, NSAIDs","['Cerebrovascular accident', 'Magnetic resonance imaging brain']",1,PFIZER\BIONTECH,IM 1047205,VA,80.0,F,very labored breathing i used albuterol nebulizer for breathing treatments to relieve symptoms. symptoms lasted for 2 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/19/2021,6.0,PVT,"albuterol, calcium-vitamin D, diclofenac DR, gabapentin, levothyroxine, losartan-hydroCHLOROyhiazide, multi-Vitamin PO, Omega-3 Fatty Acids-Vitamin E, tramadol",,COPD,,none,"['Chronic obstructive pulmonary disease', 'Dyspnoea']",UNK,MODERNA,IM 1047206,MA,41.0,F,"Red, itchy rash at injection site. Started 8 days after vaccine, increasingly worsening until day 12 after vaccine. Initially started about the size of a dime. Got to 6 x 6 inches with a raised red edge. After day 12 gradually improved. Now at day 26, still have a small red itchy patch at site of injection surrounded by a slightly larger discolored patch that is lighter than the skin around it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/04/2021,8.0,PUB,None,None,None,,Shellfish (specifically mollusks),"['Injection site discolouration', 'Injection site rash', 'Injection site swelling', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 1047207,NC,36.0,F,"Itching, eyes swelling immediately after vaccine administration that did not resolve with Benadryl, and BP 140/90, patient was later taken away by EMS",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,SEN,Benadryl,,,"Itching and hives on the back, groin, throat and mouth. Vaccinated on 12/29/2020 by the moderna vaccine.",Modern vaccine,"['Eye pruritus', 'Eye swelling', 'Immediate post-injection reaction']",2,MODERNA,IM 1047208,SC,75.0,F,Sore arm; Temp of 100 for 2 days; general aches; fatigue; zero energy; headache on day 3,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,UNK,"Armour Thyroid; Simvastatin; Singular: Meloxicam; Lisinoprol; Prilosec; Zolpidem - ASA 325; Melatonin; Zyrtec, Mucinex; Nasocort; Multi vitamin; Fish Oil; Salmon oil (I don't eat fish!!); Big B 100; C; Calcium; CLA; Cranberry; E; Flaxseed",None. Receive allergy shots every 1 - 2 weeks.,"Hypo thyroid, ostiopenia; multiple allergies;","12/15/20 Shingles Shot #1 severe arm pain, immobility of arm/ 2 days",Penicillin; Tetracycline; Cleocin; Cipro; Bactrim,"['Asthenia', 'Body temperature increased', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 1047209,NC,88.0,M,"Upon entering vaccine administration information from today's clinic into immunization registry, I noticed the patient already received 2 doses of this vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,SEN,,,,,,['Extra dose administered'],3,MODERNA,IM 1047210,MO,84.0,F,Pt was discharge by the facility with no follow up instructions or their vaccination card. Pt is lost to followup,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/14/2021,02/01/2021,18.0,PHM,,,,,,['Unevaluable event'],2,MODERNA,IM 1047212,FL,57.0,M,"Day after vaccine arm was very very sore, with a hard lump on arm at injection site. He states he felt hot flashed and then cold flashes that continue to this day. States ' I feel like I have critters crawling up my skin starting at my legs and going through my body. Has headaches that start at the top of his head then pain radiates down the left side and then head feels very warm. At times he feels ""like I am in a tunnel "" and ""everything slows down (mental/cognitive)"" Continues s to this day to feel like there are ""lumps within soft tissue areas on inner thigh, back and burning sensations. Chills on and off daily Exceptionally tired, no energy, feels drained. No changes in blood pressure",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/12/2021,1.0,WRK,Coreg Propanolol,None,Hypertension,,NKA,"['Asthenia', 'Burning sensation', 'Chills', 'Fatigue', 'Feeling abnormal', 'Feeling hot', 'Feeling of body temperature change', 'Formication', 'Headache', 'Injection site mass', 'Limb mass', 'Pain', 'Pain in extremity', 'Skin mass']",2,PFIZER\BIONTECH,IM 1047213,LA,80.0,F,"Pt. felt extremely week and her legs gave out. She fell, the daughter put her in bed and she slept. She woke up around midnight to urinate and she felt better, still week but better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PHM,"Lisinopril, Metoprolol, Aspirin, Vitamin D3 1000u, Myrbertriq,",Cystitis,"HTN, cystitis",,No Known Allergies,"['Asthenia', 'Dysstasia', 'Fall']",2,MODERNA,IM 1047215,NJ,26.0,M,"pt is hospitalized 2/21/21; current LP is pending; pt has fevers, occipital pain, malaise, neck pain, vomiting; elevated ESR & CRP; MRI & Ct Scan are negative. infectious disease physician Dr.'s differential diagnosis is: Meningoencephalitis (LP performed and is pending results) Vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/17/2021,8.0,PVT,,,,,NKDA,"['C-reactive protein increased', 'Computerised tomogram normal', 'Encephalitis', 'Headache', 'Lumbar puncture', 'Malaise', 'Neck pain', 'Pyrexia', 'Red blood cell sedimentation rate increased']",2,PFIZER\BIONTECH,IM 1047216,SC,80.0,F,"Patient is a 80-year-old female past medical history dementia, carotid artery stenosis, hypertension, GERD, anxiety/depression, etc. Patient presents to the emergency room with her husband secondary to muscle loss in the area where she received a Covid vaccine on 1/29/2021. Husband states that she had equal and normal symmetrical shoulders. On 29 January she did have her first Covid vaccine injection the left shoulder. Has been noticed that the muscle in the area started to reduce significantly almost where there is a hole/defect. Patient denies any pain or discomfort. There was no report of significant bruising over the area. No redness or fevers. Husband states that he is also noticed patient having bruising bilateral forearms intermittently over the past few weeks. No other complaint. No modifying features. * note physician note from ED visit says vaccinated on 1/29, but her appointment was on 1/28.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,02/18/2021,21.0,PVT,"aspirin (BAYER) 81 mg chewable tablet candesartan (ATACAND) 32 MG tablet cyanocobalamin, vitamin B-12, 2,500 mcg tab tablet donepezil (ARICEPT) 10 MG tablet ferrous sulfate 325 mg (65 mg iron) tablet fluticasone (FLOVENT HFA) 44 m","Cath Mitral Valve Prolapse Add as: unknown 9/23/2016  Abscess of foot New 9/23/2016  Acute sinusitis New Add as: Acute infection of nasal sinus 9/23/2016  Allergic rhinitis New Add as: Atopic rhinitis 9/23/2016  Cerebral microvascular disease New 5/22/2017 5/22/2017  Cerumen impaction New 9/23/2016  2 Chronic lower back pain New Add as: Chronic low back pain 9/23/2016  Eosinophilic esophagitis New Add as: EE (eosinophilic esophagitis) 9/23/2016  Iron deficiency New 9/23/2016  MCI (mild cognitive impairment) New 5/22/2017 5/22/2017  Osteopenia New 9/23/2016  Overactive bladder New 9/23/2016  Resolve Gastroesophageal reflux disease without esophagitis On chart Local Medical Record 10/5/2017 10/5/2017 Acid reflux disease Similar Add as: Gastroesophageal reflux disease 9/23/2016  Resolve Health maintenance examination On chart Local Medical Record 10/5/2017 10/5/2017 Visit for screening mammogram Similar Add as: Encounter for screening mammogram for malignant neoplasm of breast 9/23/2016  Resolve Mixed hyperlipidemia On chart Local Medical Record 10/5/2017 12/19/2019 Hyperlipidemia Similar 9/23/2016  Resolve Weight loss On chart Local Medical Record 1/17/2018 1/17/2018 Weight loss, abnormal Similar Add as: Abnormal loss of weight 9/23/2016  Resolve Abnormal glucose On chart Local Medical Record 2/25/2020 4/29/2020  Resolve Acute renal failure (ARF) (HCC) On chart Local Medical Record 1/3/2019 1/3/2019  Resolve AKI (acute kidney injury) (HCC) On chart Local Medical Record 12/19/2018 12/19/2018  Resolve Anemia On chart Local Medical Record 2/24/2020 2/24/2020  Resolve Anxiety with depression On chart Local Medical Record 9/26/2018 9/26/2018  Resolve Arthritis of first metatarsophalangeal (MTP) joint of left foot On chart Local Medical Record 9/11/2020 9/11/2020  Resolve B12 deficiency On chart Local Medical Record 10/5/2017 2/24/2020  Resolve Bunionette of right foot On chart Local Medical Record 9/11/2020 9/11/2020  Resolve Dizziness On chart Local Medical Record 12/18/2018 12/19/2018  Resolve Hypercalcemia On chart Local Medical Record 2/28/2019 2/28/2019  Resolve Late onset Alzheimer's disease without behavioral disturbance (HCC) On chart Local Medical Record 10/5/2017 12/19/2019  Resolve Nauseated On chart Local Medical Record 12/31/2018 12/31/2018  Resolve Pneumonia due to organism On chart Local Medical Record 2/26/2020 2/26/2020  Resolve Postmenopausal bleeding On chart Local Medical Record 2/28/2020 2/28/2020  Resolve Right carotid bruit On chart Local Medical Record 12/19/2018 12/19/2018  Resolve Vitamin D deficiency On chart Tentative and linkable Local Medical Record 2/25/2020 4/29/2020","Cath Mitral Valve Prolapse Add as: unknown 9/23/2016  Abscess of foot New 9/23/2016  Acute sinusitis New Add as: Acute infection of nasal sinus 9/23/2016  Allergic rhinitis New Add as: Atopic rhinitis 9/23/2016  Cerebral microvascular disease New 5/22/2017 5/22/2017  Cerumen impaction New 9/23/2016  2 Chronic lower back pain New Add as: Chronic low back pain 9/23/2016  Eosinophilic esophagitis New Add as: EE (eosinophilic esophagitis) 9/23/2016  Iron deficiency New 9/23/2016  MCI (mild cognitive impairment) New 5/22/2017 5/22/2017  Osteopenia New 9/23/2016  Overactive bladder New 9/23/2016  Resolve Gastroesophageal reflux disease without esophagitis On chart Local Medical Record 10/5/2017 10/5/2017 Acid reflux disease Similar Add as: Gastroesophageal reflux disease 9/23/2016  Resolve Health maintenance examination On chart Local Medical Record 10/5/2017 10/5/2017 Visit for screening mammogram Similar Add as: Encounter for screening mammogram for malignant neoplasm of breast 9/23/2016  Resolve Mixed hyperlipidemia On chart Local Medical Record 10/5/2017 12/19/2019 Hyperlipidemia Similar 9/23/2016  Resolve Weight loss On chart Local Medical Record 1/17/2018 1/17/2018 Weight loss, abnormal Similar Add as: Abnormal loss of weight 9/23/2016  Resolve Abnormal glucose On chart Local Medical Record 2/25/2020 4/29/2020  Resolve Acute renal failure (ARF) (HCC) On chart Local Medical Record 1/3/2019 1/3/2019  Resolve AKI (acute kidney injury) (HCC) On chart Local Medical Record 12/19/2018 12/19/2018  Resolve Anemia On chart Local Medical Record 2/24/2020 2/24/2020  Resolve Anxiety with depression On chart Local Medical Record 9/26/2018 9/26/2018  Resolve Arthritis of first metatarsophalangeal (MTP) joint of left foot On chart Local Medical Record 9/11/2020 9/11/2020  Resolve B12 deficiency On chart Local Medical Record 10/5/2017 2/24/2020  Resolve Bunionette of right foot On chart Local Medical Record 9/11/2020 9/11/2020  Resolve Dizziness On chart Local Medical Record 12/18/2018 12/19/2018  Resolve Hypercalcemia On chart Local Medical Record 2/28/2019 2/28/2019  Resolve Late onset Alzheimer's disease without behavioral disturbance (HCC) On chart Local Medical Record 10/5/2017 12/19/2019  Resolve Nauseated On chart Local Medical Record 12/31/2018 12/31/2018  Resolve Pneumonia due to organism On chart Local Medical Record 2/26/2020 2/26/2020  Resolve Postmenopausal bleeding On chart Local Medical Record 2/28/2020 2/28/2020  Resolve Right carotid bruit On chart Local Medical Record 12/19/2018 12/19/2018  Resolve Vitamin D deficiency On chart Tentative and linkable Local Medical Record 2/25/2020 4/29/2020",,sulfonamides- shortness of breath,"['Contusion', 'Eosinophil count normal', 'Haematocrit decreased', 'Haemoglobin decreased', 'Injection site muscle atrophy', 'Lymphocyte count decreased', 'Lymphocyte percentage', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin increased', 'Mean cell volume increased', 'Mean platelet volume normal', 'Monocyte count increased', 'Monocyte percentage', 'Neutrophil count decreased', 'Neutrophil count normal', 'Neutrophil percentage', 'Red blood cell count decreased', 'Red cell distribution width normal', 'White blood cell count decreased']",1,PFIZER\BIONTECH,IM 1047218,NC,77.0,M,"CHILLES, LOW GRADE FEVERE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,UNK,SIMVASTATEN,,NONE,,,"['Chills', 'Pyrexia']",UNK,MODERNA, 1047220,PA,40.0,F,"Sore throat, difficulty swallowing. Left arm pit pain for a few days. Had swelling behind left knee with pain, but that has spontaneously resolved. Axillary pain both sides but greater on left side. Ibuprofen as needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/11/2021,13.0,PVT,"Zyrtec, Flonase",None,Seasonal Allergic Rhinitis,,NKA,"['Arthralgia', 'Axillary pain', 'Dysphagia', 'Joint swelling', 'Oropharyngeal pain']",1,UNKNOWN MANUFACTURER,IM 1047221,GA,70.0,F,"Patient was given the Pfizer covid vaccine in left deltoid at 3:25 pm. At 3:32 pm patient c/o jaw-throat-tingling. Also reported, ""Buzzing like a tuning fork."" Patient reports hx of panic attacks and tremors. At 3:45 pm Benadryl 50 mg PO was administered. Patient questions, ""Do you have anything stronger?"" She also instructed, ""Crush up the pills to make them work faster."" Vitals signs were monitored: At 3:32 pm BP 156/85, at 3:42 pm BP 158/91, HR 72, at 3:48 BP 178/92, HR 85, Resp 15, O2 Sat 98% room air. Patient advised she needed to call her sister and was talking on the cell phone with full/complete sentences. No shortness of breath observed. No wheezing noted. DC BP was 167/79, HR 68. Sister arrived and assisted with decompression of symptoms. Discharged alert and oriented x 4.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,"Thyroxin, Losartan, Xanax, Celexa, Mucinex, Diclofenac",Unknown,"Panic attacks, HTN, hypothyroidism",,NKA,"['Pharyngeal paraesthesia', 'Tinnitus']",1,PFIZER\BIONTECH,IM 1047222,,32.0,F,"Migraine headache, exhaustion, pain at injection site, shortness of breath, body aches, chills. Took ibuprofen at onset of symptoms, headache subsided but the rest lingered for another 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,UNK,Microgestin FE 1/20 (contraceptive),None,None,,None,"['Chills', 'Dyspnoea', 'Fatigue', 'Injection site pain', 'Migraine', 'Pain']",UNK,PFIZER\BIONTECH, 1047223,NY,68.0,F,"Itching started 24-48 hours after the vaccination and was reported to VSafe and has continued til today. My daily VSafe check ins have ended, so I'm reporting a new rash at the injection site. Only today did I notice a round rash about 2 inches in diameter with a leading red edge, but I didn't look at the injection site for the last couple of days, so it may have been there before.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/13/2021,2.0,PVT,"levothyroxine, vitamin D3, Vitamin K2, New Chapter Bone Strength Take Care, Pure Encapsulations O.N.E. multivitamin",none,"hypothyroidism, osteoporosis",,none,"['Injection site erythema', 'Injection site rash', 'Pruritus']",1,MODERNA,IM 1047224,MA,25.0,F,"Patient received vaccine, then proceeded to the monitoring station in the clinic. Upon arrival to the Monitoring station, client stated she felt light-headed and appeared dazed. Client escorted to recliner chair to recover. BP 120/78 while seated with legs reclined. Gatorade was given, which the client drank with good effect. After 20 minutes, the client sat up (no longer reclining) and tolerated the position change well. After an additional 5 minutes, the client stood up and felt she had recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,SCH,Unknown,None stated.,None stated.,,Amphotericin B,"['Dizziness', 'Feeling abnormal']",2,PFIZER\BIONTECH,IM 1047225,CA,65.0,F,Feeling mostly normal but tired fell asleep at 11PM day of second vaccine. Woke up 1 hour later and got up to go to the bathroom but felt fine. Went out to the hall bathroom so as not to wake husband in Master bath. Urinited and got up slowly as I always do and walked out to the hallway to go back to bed. I lost consciousness and came to when my husband who heard a thud came and found me out having fallen down the stairs.. head on the landing and feet above the landing. I have no recollection of it once leaving the bathroom and i would have headed away from the stairs which was just to the left of the bathroom doorway. I didn't feel any pain. Later found a bump on my forehead of the right side of my face and a bruised lip. He said my back was wet with sweat and I took a couple minutes to come to. After returning to the bed.. i immediately had to empty bowels. Diarrhea.. then the rest of the night in Chills. No fever. Slept most of the next day and night. Headache and joint aches and swelled lymph nodes in neck.. Fatigue through 20th. Mostly better by the 21st. Still today on 22 I am being careful when going from prone to standing. I feel more head pressure getting up and maybe I notice a little nausea when rising. I may just be worried about fainting again. It has never happened to me before. I do have very good blood pressure on the lower side so I was always careful to get up slowly but never fainted. Neck is sore.. Not sure if lymph nodes or something to do with fall.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/17/2021,0.0,PVT,Levothyroxine. Bioidentical Estrogen and Progesterone cream,None,None,,None,"['Anxiety', 'Arthralgia', 'Chills', 'Diarrhoea', 'Fall', 'Fatigue', 'Head discomfort', 'Headache', 'Hyperhidrosis', 'Loss of consciousness', 'Lymphadenopathy', 'Nausea', 'Neck pain', 'Oral contusion', 'Swelling face']",UNK,PFIZER\BIONTECH, 1047226,ID,41.0,F,Racing heart for up to 8 hours over 152 pulse started 30 min after injection,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,PVT,effexor 150mg Lovothyroxine .075mg Trazadone 50mg Anastrozole 1mg,none,none,,none,"['Blood test normal', 'Computerised tomogram normal', 'Palpitations']",1,PFIZER\BIONTECH,ID 1047227,,,U,"at about hr 10 I began to feel very cold and progressed to severe shaking chills and rigors which lasted all night and into the next morning, I also had a low grade temp (which it is not outside of normal for vaccines) I also had severe body aches and severe headaches all of the first day post injection with body aches improving but still present today",Not Reported,,Not Reported,Not Reported,,Not Reported,,,,,UNK,,,,,,"['Body temperature abnormal', 'Chills', 'Feeling cold', 'Headache', 'Pain', 'Tremor']",1,MODERNA,IM 1047228,KY,43.0,F,"Feet started turning red. Progressed to small under skin blisters, cracking. Toes & entire foot now turns purple. Went to primary doctor 2/22/21 & was referred to Vascular doctors. Was also instructed to turn in adverse effects to CDC.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/09/2021,4.0,PVT,Tremfya Injection Amphetamine-dextroamphetamine 30mg Spironolactone 50mg,,Psoriasis,,Penicillin Sulfa,"['Blister', 'Erythema', 'Skin discolouration']",1,MODERNA,IM 1047229,KS,66.0,F,Patient complaint of shortness of breath and chest discomfort. Patient assessed by EMS. SVT detected and transported to Hospital.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PUB,unknown,Cancer,,,None reported,"['Chest discomfort', 'Dyspnoea', 'Supraventricular tachycardia']",1,MODERNA,IM 1047230,IL,83.0,F,bump at injection site (adema),Not Reported,,Not Reported,Not Reported,,Not Reported,,02/01/2021,02/04/2021,3.0,PHM,,,,,,['Injection site oedema'],1,PFIZER\BIONTECH,IM 1047231,FL,66.0,M,"About 60-90 minutes post injection he began to feel bad. Voice became very raspy, felt weak, felt like someone was chocking him. Extremely diaphoretic, felt very hot, had to remove shirt. Felt SOB, Called 911 with EMT response. BP 220/160, declined transport to ED, went home with family. BL more stable by 2100 that day. Day after shot blood sugar elevated at 220, normally 150/180.ALso vomiting clear fluids. Still not feeling well 4 days later, feels like ""in another world"", feels weak at times. Feels dizzy. Has and ""eerie"" feeling. Feels ""equilibrium is off"". Took Benadryl on 2/20. Has some disorientation ""forgot what he was doing"" at one point. Cramps in bilateral legs, both thighs and calves. Has headaches, migraine like at 3am without an elevated BP. Encouraged to see PCP, has appointment with physician on 3/2",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,WRK,Lisinopril Metformin Lantus,none,IDDM Hypertension,,NKA,"['Asthenia', 'Balance disorder', 'Blood glucose increased', 'Choking sensation', 'Diabetes mellitus', 'Disorientation', 'Dizziness', 'Dysphonia', 'Dyspnoea', 'Feeling abnormal', 'Feeling hot', 'Headache', 'Hyperhidrosis', 'Memory impairment', 'Migraine', 'Muscle spasms', 'Vomiting']",1,MODERNA,IM 1047232,PA,75.0,F,Itch rash on face and neck,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PVT,,,,,,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 1047233,IL,76.0,M,"Our infectious disease physician is reviewing notes from previous hospital stay for this patient who reports having had DRESS 2 days after receiving the MOderna COVID vaccine on 2/4/2021. MD cannot be sure if the DRESS is related to vaccine or new initiation of allopuriol as the drug was started 2 weeks prior to this reaction and is known to cause this. He wants it reported as a precaution, again cannot be sure what caused this, the vaccine or the new medication.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/04/2021,02/06/2021,2.0,PVT,Tylenol 500 mg q 4 hours PRN pain Wixela Inhub 1 puff BID Apixaban 5 mg PO BID Pravastatin 40 mg Daily carvedilol 25 mg BID amlodipine 10 mg daily furosemide 40 mg daily allopurinol 300 mg daily (NEW START AS OF JANUARY 2021) pantoprazole 4,new onset gout in January 2021,"hypertension, hyperlipidemia, asthma, CAD, GERD, vitamin d deficiency, congestive heart failure, CKD",,Haldol - anaphylaxis lisinopril - angioedema,['Drug reaction with eosinophilia and systemic symptoms'],1,MODERNA, 1047234,GA,66.0,U,Felt like I had a bad flu for about 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,UNK,"Heart, diabetes, thyroid meds",None,See 9,,None,['Influenza like illness'],2,MODERNA,IM 1047235,CA,80.0,F,"I am reporting that I was diagnosed with shingles after 2 wks of getting my 1st dose of Covid vaccine shot in my upper left arm. My arm starting hurting & a few days later, I broke out with tiny dark red spots inside a red swollen circle. Arm remained with a burning aching pain. My dermatologist said it was definately shingles & prescribed a 10 day treatment of antiviral medication. She didn't know if it was caused by the vaccine but should report this. The shingles are just below the shot area.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/09/2021,8.0,UNK,,,,,,"['Herpes zoster', 'Injection site reaction', 'Pain', 'Pain in extremity', 'Rash macular', 'Skin swelling']",1,PFIZER\BIONTECH,IM 1047236,MI,84.0,M,cellulitis and edema left elbow. low suspicion that related,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/19/2021,2.0,UNK,,,"renal cell carcinoma s/p cryotherapy, prostate cancer, hypertension, carotid stenosis",,,"['Cellulitis', 'Oedema']",UNK,MODERNA, 1047237,WA,75.0,F,induration about the size of a quarter or larger,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/17/2021,14.0,PUB,"Prozac, hctz, levothyroxine, montelukast, omeprazole",none,"hyperlipidemia, glucose intolerance",,"bees, atenolol",['Induration'],1,MODERNA,IM 1047238,NH,73.0,F,"Large (4? diameter) red, hot, hard rash. Mildly tender to touch.. Very itchy. Hydrocortisone cream applied. Itching less intense after 4 days and rash almost resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/18/2021,7.0,OTH,"Atenolol, synthroid, myrbetriq, raloxifene, Calcium, magnesium, melatonin",None,"Arthritis, asthma","Slight rash at injection site, annual flu shot","Ergot, adhesive, nickel","['Erythema', 'Induration', 'Pruritus', 'Rash', 'Skin warm', 'Tenderness']",1,MODERNA,IM 1047239,CT,61.0,F,"On the date of vaccine, had no markings. 3 days later the size of a pencil eraser, dark blue/reddish with a black dot in the middle of it on her arm at the vaccine site. Then on Thursday, every joint in her body hurt and this continued until Saturday. On Saturday she had a big red whelt on the arm that progressively got larger. She still has some aches in her joints, but not as severe. The rash is deep red today, swollen with hard ridges, very itchy and very hot to touch. She has not taken anything for it. She has been having a harder time than usual breathing, but not sure if it's related to the vaccine or not. She has less than 20% of her lungs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/16/2021,3.0,MIL,"Azithromycin, Rosuvastatin, Metoprolol, aspirin 81 mg, Xolpidem.",None.,"Coronary artery disease, emphysema, alpha-I antitrypsin deficiency.",,Corn and wheat,"['Arthralgia', 'Dyspnoea', 'Erythema', 'Injection site discolouration', 'Injection site induration', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Rash erythematous', 'Urticaria']",1,MODERNA,IM 1047240,NV,81.0,M,"Developed weakness/numbness in the entire hand within 24 hours of being given the vaccine. Patient was seen on 2/19 and while some of the numbness had resolved, she did have findings consistent with ulnar neuropathy (weakness in hand and numbness in 4th/5th digits)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,PVT,Armour Thyroid,None,Hypothyroidism,,"PCN, Codeine, erythromycin, Tetracycline","['Cubital tunnel syndrome', 'Hypoaesthesia', 'Muscular weakness']",2,MODERNA,IM 1047241,IL,67.0,F,"Nine days after injection, a large red area appeared at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2020,02/05/2020,9.0,PUB,None,None,None,,"Penicillin, Yeast, Tree Nuts",['Injection site erythema'],1,MODERNA,SYR 1047242,,34.0,F,"Pt experienced the following: Muscle Aches, Joint pain, nausea, dizziness, chest tightness. BP 137/84 HR 100-138",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/25/2021,3.0,PHM,,,,,,"['Arthralgia', 'Chest discomfort', 'Dizziness', 'Myalgia', 'Nausea']",1,MODERNA,IM 1047243,AL,25.0,F,"Chills, Fever, Fatigue, Nausea, Migraine, No Appetite, Shakey",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/19/2021,2.0,PVT,"Nikki, Vyvanse",None,None,,None,"['Chills', 'Decreased appetite', 'Fatigue', 'Migraine', 'Nausea', 'Pyrexia', 'Tremor']",UNK,PFIZER\BIONTECH, 1047244,NY,57.0,F,"The vaccine was given on 2/9/21. No initial pain or problems. 4 days later, my stomach felt like a feather was tickling it, then turned hot, red, itchy, a rash formed and then hives covered my torso--stomach, chest, neck, and around the injection site. On Wednesday, 2/17/21, I saw my doctor who prescribed prednisone which I began taking on Thursday. The itchy feeling subsided but hives still visible. The doctor said the reaction is not life-threatening.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/15/2021,6.0,OTH,None,None,Asthma (mild),,sulpha antibiotics Demerol,"['Erythema', 'Formication', 'Injection site urticaria', 'Pruritus', 'Rash', 'Skin warm', 'Urticaria']",1,MODERNA,SYR 1047245,CA,50.0,F,"Caregiver states had ""headache, lightheadedness, hot flashes, runny nose, SOB, cough"" a day after receiving 2nd dose Moderna vaccine. Info received 02/22/21 when caregiver provided note from her Private MD to return to work. First dose Moderna 12/30/2020 with no known reaction (info entered into next page although over 1 month in between doses).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/02/2021,1.0,PVT,none known,none known,none known,,NKA,"['Cough', 'Dizziness', 'Dyspnoea', 'Headache', 'Hot flush', 'Rhinorrhoea']",2,MODERNA,IM 1047246,MI,80.0,F,02/11/21: Fever 100.1 @ 8:00 a.m. ; mild headache; extreme fatigue 02/12/21: Fever 101.5 @ 8:00 a.m.; headache worse; extreme fatigue Fever 101.9 @ noon ; headache same; extreme fatigue 02/13/21: Fever 100.9 @ 8:00 a.m.; mild headache; mild fatigue 02/14/21: temp normal; no headache; mild fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/11/2021,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Pyrexia']",2,MODERNA,SYR 1047247,IN,54.0,F,"HEADACHE, NAUSEA, AND FATIGUE",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/24/2021,01/25/2021,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Nausea']",1,MODERNA,IM 1047248,MT,29.0,M,Headache & Injections site pain,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Headache', 'Injection site pain']",2,MODERNA,IM 1047249,UT,56.0,F,"After first COVID-19 vaccine, patient experiencing prolonged fatigue, joint and muscle pains, headache and nausea. Symptoms have lessened over the course of 3 weeks, but are still present. Patient has about 2/3 the normal physical function, and feels to be working at about 1/2 of their normal working capacity. The patient followed up via phone call the COVID-19 nursing line, COVID test taken, negative, and was advised supportive care and acetaminophen if needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,WRK,none,none,none,,none,"['Arthralgia', 'Fatigue', 'Headache', 'Mobility decreased', 'Myalgia', 'Nausea', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 1047250,PA,39.0,M,2 weeks of persistent urticaria confined to right arm (vaccine given in left arm),Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/12/2021,1.0,PVT,gabapentin 300mg TID,none,"schizophrenia, drop foot",,latex,['Urticaria'],1,MODERNA, 1047251,NC,36.0,F,"Itching in the groin, entire back, throat and mouth 1 hour after receiving the vaccine, pt self administered an epipen and followed up with primary care dr.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,SEN,,,,,,['Pruritus'],1,MODERNA,IM 1047252,TN,79.0,F,"None immediately, On 9th day after arm is sore, red and swollen (large area) at injection site and a little itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/22/2021,9.0,PHM,atorvastatin 20mg; amlodipine/valsartan 5/320; esomeprazole 40 mg; ursodiol 500mgx2; zinc 50mg; calcium 1200mg; aspirin 81mg,none,gall stones w/out gall bladder,,none,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 1047253,IN,69.0,F,"Redness and itchiness around injection site, extending 4x4 inches. Hard and puffy at site of injection. Administered on the 8th of February, with reactions occurring at 16th of February.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/16/2021,8.0,PUB,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Skin swelling']",1,MODERNA,IM 1047255,WA,35.0,F,"Chills, body aches, joint pain and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/18/2021,0.0,WRK,"Singulair, Zoloft, vitamin D and B",None,"Mild asthma, gastroparesis",,"Soy, gluten, sulfa medications, stone fruit.","['Chills', 'Fatigue', 'Pain']",2,PFIZER\BIONTECH,IM 1047256,,28.0,F,"10 minutes after vaccine administration, pt developed significant and generalized pruritis, more so over her right arm, but over both upper extremities. She did not develop any signs of respiratory compromise or hypotension, so was given 50mg Benadryl and her itching improved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/06/2021,0.0,PVT,,,Seizure disorder,,Lurasidone,['Pruritus'],1,PFIZER\BIONTECH,IM 1047257,WI,48.0,F,"The day after my vaccine, I had flu-like symptoms. Those have subsided, but since then, I have had swollen, tender lymph nodes in both armpits and both sides of my neck.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,PVT,Tylenol,,,,,"['Full blood count normal', 'Influenza like illness', 'Lymphadenopathy', 'Tenderness']",2,MODERNA,IM 1047258,CA,36.0,F,Bell?s palsy,Not Reported,,Not Reported,Yes,2.0,Not Reported,,01/25/2021,02/08/2021,14.0,UNK,,,,,,['Facial paralysis'],1,MODERNA,SYR 1047259,UT,79.0,M,Local redness and swelling 10 days post second Covid shot,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/22/2021,10.0,PVT,"amlodipine, ezetimibe, losartan",,,,,"['Erythema', 'Swelling']",2,MODERNA,IM 1047260,,74.0,F,Patient began feeling extremely thirsty shortly after receiving vaccine. She stopped several times on her drive home to get bottles of water because she was so thirsty. She then vomited up the water. Symptoms resolved after several hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PUB,,,,,,"['Thirst', 'Vomiting']",1,PFIZER\BIONTECH,IM 1047261,,22.0,F,"Pt had previously tested positive for COVID on 01/08/21 She experienced prolonged symptoms after vaccination that included: vomiting, diarrhea, headache >4 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,02/22/2021,32.0,PHM,,,,,,"['Diarrhoea', 'Headache', 'Vomiting']",1,MODERNA,IM 1047263,TX,51.0,F,I CONTACTED THE PATIENT TODAY AND SHE INFORMED ME OF HER ADVERSE REACTION. SHE REPORTED THAT ON 01/12/21 10 MINUTES AFTER MODERNA ADMINISTRATION PATIENT WENT TO HER VEHICLE AND SPOKE WITH SPOUSE OUTSIDE OUR PARKING LOT. SHE STATED SHE BEGAN TO FEEL THROAT TIGHTENING UP AND UNABLE TO SWALLOW SHE DROVE HERSELF TO PHARMACY AND TOOK BENADRYL. AND SYMPTOMS IMPROVED.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,PVT,"SYNTHROID, ARMOUR, DEPLIN, TRANTILEX, WELLBUTRIN, FISH OIL",NONE,HYPOTHYROIDISM AND DEPRESSION,,"PCN, CODEINE","['Dysphagia', 'Throat tightness']",1,MODERNA,IM 1047264,TX,57.0,F,"Extreme soreness in arm (I kind of think he may have administered it a little high on my shoulder so that it made my shoulder joint sore). Fatigue, low grade fever, general malaise similar to a mild flu. Lasted 24 hours, with another 24 hours feeling ""hung over"" as though recovering from a viral infection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,PUB,"Metformin, gemfibrozil, lantus, synthroid, hydrochlorothiazide, metopropol, losartan, fish oil, low dose aspirin, cinnamon, calciu, zinc, magnesium, vit c, vit d3,",None,Diabetes,,NKA,"['Arthralgia', 'Fatigue', 'Hangover', 'Influenza like illness', 'Injection site pain', 'Malaise', 'Product administered at inappropriate site', 'Pyrexia', 'Viral infection']",1,MODERNA,IM 1047265,CA,42.0,F,"Arm became itchy, red and blotchy, hot, firm at injection site exactly one week after injection. The symptoms have lasted 2 days, so far. No treatment necessary.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,PVT,"Vitamin D3, Biotin, Prozac, NuvaRing, multi vitamin",none,,,Sulfa,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth', 'Rash macular']",1,MODERNA,SYR 1047266,MT,37.0,F,"Headache, Fever, Chills, & Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pyrexia']",2,MODERNA,IM 1047267,AR,83.0,F,"Within about 20 minutes, pt began to feel dizzy, had a headache and had tightness in chest. Her blood pressure and pulse were normal. She had water and cold compress. I sat with her and her caretaker for another 15 minutes or so. The caretaker left to bring car around and we used wheelchair to help her to car. She never did pass out, and was feeling a little better. The caretaker was going to stay with her to keep a watch over her. Patient called a couple of hours later to let us know she was doing ok and had been lying down. She wasn't having the chest tightness anymore and her head felt better, but she had developed a rash across the chest.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PHM,"METOPROLOL, FOLIC ACID, LOSARTAN, SIMVASTATIN, CHEMO TREATMENT",BEING TREATED FOR LUNG CANCER,HIGH BLOOD PRESSURE; LUNG CANCER,,NKA,"['Chest discomfort', 'Dizziness', 'Headache', 'Rash']",1,MODERNA,IM 1047268,MI,48.0,M,urticarial rash all over body,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/21/2021,18.0,SCH,,,asthma,,Compazine,['Urticaria'],1,MODERNA,IM 1047269,LA,82.0,F,"On, February 3, the 7th day after vaccine, patient began itching all over her body (torso, arms, and hands). there was no rash visible. On February 7, Sunday, at 7:00 pm, her lower lip started burning. At 9:00 pm, her tongue began feeling unusual - slightly swollen. the itching had continued all this time since February 3. At 11:15 pm on February 7, she took 50 mg of benadryl and no zolpidem that night. the next morning, the itching had stopped and burning of lips stopped. Tongue did not feel normal until 3:30 pm that day, February 8.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,02/03/2021,7.0,PHM,"nifedipine, sertraline, montelukast, vitamin D, zolpidem",none,high blood pressure insomnia,"About 3 years ago, patient had breathing issues/difficulty breathing immediately following a flu vaccine injection at her doctor",hydrocodone no food or other things,"['Oral discomfort', 'Paraesthesia oral', 'Pruritus', 'Swollen tongue']",1,MODERNA,IM 1047270,GA,66.0,F,I described reactions,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,PVT,Zoloft,"The next day, the 19th, I had swollen lymph gland under armpit of arm given vaccine. By end of day, I could barely raise my arm. That's when I read women should not do a mammogram near vaccine. I had had a mammogram on February 1st and did not have information about swelling glands as adverse reaction. The place of location for vaccines need post this as precaution. I would have postpone another week, but I was following guidelines for receiving 2nd covid vaccine. The 2nd vaccine was more traumatic. I had fever, chills where I couldn't stop chattering. Today, I went to video chat with primary care doctor, and I was informed give my swelling time but if still there, she'd write script for ultrasound.",,Flu vaccine ave me issues over 30 years,Penicillin,"['Chills', 'Lymphadenopathy', 'Mobility decreased', 'Pyrexia']",UNK,MODERNA, 1047272,MI,44.0,F,"Around 11 pm on 2/20/21 I had a sore neck. I began to get achy in the middle of the night and could not sleep. On 2/21 around 9:00am I had a fever of 101F and was very achy, tired and had a mild headache. At 7:00pm on 2/21 I had a fever of 101F and was still achy and had a headache. I took two regular strength Tylenol at 9:30pm on 2/21 and that took the edge off so I could sleep. I woke up on 2/22 feeling better but still had a sore neck and arm. The whole time I had a sore arm starting on 2/20 around 3pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,OTH,"Levothyroxine, Vitamin D, B-12",none,"hypothyroidism, endometriosis",,"Pencillin, mold, dust","['Fatigue', 'Headache', 'Neck pain', 'Pain', 'Pain in extremity', 'Pyrexia', 'Sleep disorder']",2,MODERNA,SYR 1047273,NY,64.0,F,"10p.m. Saturday, 2/20/21 until about 4 a.m. Sunday, 2/21/21, Chills, fever, shaking, nose cold and teeth chattering from chills; Also on Sunday fever of 101.6; diarrhea about 10 a.m. Monday, 2/22/21 and temperature of 100.6 Monday morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,OTH,Timolol Maleate 0.5% one drop daily in right eye; Vitamin D3 50mcg; Lisinopril 10mg; Metoprolol Succ ER 25mg twice daily; Bayer Aspirin 81mg; Paroxetine HCL10m at bedtime,No,"Asthma, High blood pressure, cerebral palsy; deaf in left ear; curvature of spine; Eylea drug injected into right eye every 8 weeks",,Drugs containing Sulfa,"['Chills', 'Diarrhoea', 'Feeling cold', 'Pyrexia', 'Tremor']",1,MODERNA,IM 1047274,IL,48.0,M,"FATIGUE, NAUSEA, LEFT SIDE MUSCLE PAIN, CHILLS, SORENESS, AND CHEST PAIN.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/21/2021,01/25/2021,4.0,OTH,,,,,,"['Chest pain', 'Chills', 'Fatigue', 'Myalgia', 'Nausea', 'Pain']",1,MODERNA,IM 1047275,,58.0,M,"Pt reported body aches, chills, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/23/2021,2.0,PHM,,,,,,"['Chills', 'Headache', 'Pain']",1,MODERNA,IM 1047276,LA,57.0,M,"For two days after the second injection, which I received on Wednesday, February 3, I had fever and chills. I did not feel myself that Saturday or Sunday. Sunday evening, February 7, at 8:00pm, I had a Grand Mal seizure. I was transported to the emergency room by EMS, treated and released.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/07/2021,4.0,OTH,"Amlodopine, 81mg aspirin, atorvastatin",Mild High Blood Pressure,High Blood Pressure,,None,"['Blood ethanol normal', 'Chest X-ray normal', 'Chills', 'Computerised tomogram head normal', 'Differential white blood cell count normal', 'Electrocardiogram normal', 'Electroencephalogram normal', 'Feeling abnormal', 'Full blood count normal', 'Generalised tonic-clonic seizure', 'Magnetic resonance imaging brain normal', 'Metabolic function test normal', 'Pyrexia', 'Troponin I normal']",2,MODERNA,IM 1047277,SD,49.0,M,"Received first COVID Vaccine on 02/01/2021 and on 02/18/2021 started with symptoms of sore throat's, cough, chills and achy- seen in clinic on 02/22/2021 and tested positive for COVID 19",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/18/2021,17.0,PVT,"OMEPRAZOLE CAP,EC 20MG, LISINOPRIL TAB 10MG, METFORMIN TAB,SA 500MG",NONE,Diabetic,,None,"['COVID-19', 'Chills', 'Cough', 'Oropharyngeal pain', 'Pain', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1047278,OR,58.0,F,"Initially, sore arm and some upper trunk muscle soreness on the day after vaccine. 3 days later, admitted to the hospital after witnessed fall by husband - cardiac arrest. Seizures seen today. Unsure if directly related to the vaccine, as there are several days between vaccination and the arrest, but no new medications or issues since vaccination.",Not Reported,,Yes,Yes,1.0,Not Reported,N,02/18/2021,02/21/2021,3.0,UNK,"Bupropion 300 mg ER QD, buspirone 10 mg BID, levothyroxine 50 mcg QD, sertraline 200 mg QD",,,,Penicillin - hives,"['Cardiac arrest', 'Fall', 'Myalgia', 'Pain in extremity', 'Seizure']",1,MODERNA,IM 1047279,NY,73.0,M,"Chills, affected muscles...very weak, dead weight tired could not stand up, fell on floor while in bathroom, called paramedics ...weakness and stability for several days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/11/2021,1.0,PHM,"Baby aspirin, Atorvastatin 40mg. Carbidopa-Levodopa for Parkinson?s 25mg 100mg. Colchicine O.6 mg.Metformin HCL 1000mg 2x. Oxybutynin Chloride (Prostate) 10mg. Pregabalin (Neuropathy) 75mg. Sucralfate 1 GM/10ML susp 2tsps meals. Tr",None,"Parkinson?s, Diabetes, Neuropathy, Had Covid March 26,, 2020 Hospitalized",,None,"['Asthenia', 'Chills', 'Discomfort', 'Dysstasia', 'Fall', 'Gait disturbance', 'Muscular weakness']",1,MODERNA,SYR 1047280,MN,42.0,F,"Day after vaccine unrelenting fsevere headache, jaw pain, charlie horses. Day 2 after vaccine arm swelling, HOT, spreading getting larger during the day along with headache. Day 3 after vaccine arm still red, geographic pattern on arm in different location, never localized and very irregular in shape- tingly feeling started in pinky and ring finger of left arm where vaccine was given. Day 4 after vaccine RIGHT had not associated with vaccine has tingly feeling. - like hit funny bone. No numbness, just tingly",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/18/2021,1.0,PUB,none,none,none,,"codeine, morphine","['Erythema', 'Headache', 'Muscle spasms', 'Pain in jaw', 'Paraesthesia', 'Peripheral swelling', 'Skin warm']",2,MODERNA,IM 1047281,AR,78.0,F,"My tongue has turned dark gray/black... Not sure of the exact day it turned gray, but it has been this way for 2 plus weeks...",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/02/2021,8.0,PUB,Citalopram 20mg Melatonin 10mg Vitamin E 400iu Vitamin D3 5000iu Restasis (0.4)ml Aripiprazole 2mg Niacin 250mg Vitamin B12 1000,,,,,['Tongue discolouration'],UNK,MODERNA,SYR 1047282,FL,83.0,F,"Patient felt fine on Friday afternoon and evening after shot. Felt fine on Saturday until the afternoon when she started feeling fatigued and chilled. Decided to take a warm bath at about 6pm. Was found dead in bathtub at approximately 7pm with blisters on arms, legs, and face.",Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,PVT,duloxetine 20 mg daily cyclobenzaprilne 10 mg as needed for pain meclizine 25 mg as needed for nausea,none,"none, other than back pain",,Benadryl Diazepam Valium,"['Autopsy', 'Blister', 'Chills', 'Death', 'Dizziness', 'Fatigue']",2,MODERNA,IM 1047283,TX,86.0,F,"PATIENT HAS HISTORY OF DEMENTIA. VOLUNTEER SERVICE SENT HER TO GET VACCINE AT CLINIC NOT KNOWING SHE HAD HER FIRST DOSE ALREADY AT NURSING HOME, WHICH WAS THE PFIZER VACCINE. SHE STATED ""I GOT A SHOT BUT DONT KNOW WHAT I HAD"". UNAWARE OF WHAT SHE HAD, NURSE WHO TOOK CARE OF HER ON FLOOR WAS ABLE TO CONFIRM FIRST DOSE OF PFIZER WITH PHARMACIST AND EMPLOYEE HEALTH NURSE. VAERS REPORT PLACED DUE TO MIXED DOSES AND INTERNAL ERROR. CLINIC STAFF UNAWARE THAT PATIENT, AS WELL AS PATIENT, SHE HAD THE PFIZER VACCINE BEFORE COMING INTO THE COVID MODERNA CLINIC. NO ADVERSE REACTIONS NOTED WITH MODERNA VACCINE GIVEN.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,WRK,MULTIPLE; CAME FROM NURSING HOME,NONE REPORTED,UTI IN JANUARY 2021. HOSPITALIZED.,,NONE REPORTED,"['Interchange of vaccine products', 'No adverse event']",1,MODERNA,IM 1047284,TX,56.0,F,Mrs. received Moderna second dose five days before due date and grace period. No adverse reactions noted at time of injection or observation.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/11/2021,02/11/2021,0.0,PUB,,,,,No known allergies,"['Inappropriate schedule of product administration', 'No adverse event']",2,MODERNA,IM 1047285,AZ,66.0,F,"Nauseous, abdominal pain centered at the diaphragm. This is the same reaction I get with the erthrymiacin and vibramiacin but it was much milder. Also light headed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,OTH,,,diabetic,,eyrthrimaicin vibramycin,"['Abdominal pain', 'Dizziness', 'Nausea']",1,PFIZER\BIONTECH,SYR 1047286,NC,46.0,F,"Itchiness and tightness in the throat, light headed was, swelling of the lips, and nausea. No improvement after chewing 50 mg of Benadryl and 2 epipens.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,SEN,,,,,,"['Dizziness', 'Lip swelling', 'Nausea', 'Throat irritation', 'Throat tightness']",1,MODERNA,IM 1047287,MT,43.0,F,"Body aches, chills, sore arm, wheezing, & cough",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Chills', 'Cough', 'Pain', 'Pain in extremity', 'Wheezing']",2,MODERNA,IM 1047288,CA,16.0,F,Patient was vaccinated at age of 16 and 11 months.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,SCH,Patient has an IUD.,None.,None.,,None.,['Product administered to patient of inappropriate age'],1,MODERNA,IM 1047289,IN,86.0,M,"Pt reported feeling ""dizzy"" 5 min s/p vaccine. Initial vitals were: 153/117 HR52. at 15 minute post 191/68 HR 46. and 30 min post 181/68 HR 52. Pt ambulated with only standby assistance to to restroom to void times 2 during his 30 min stay. Pt stayed a total of 60 minutes total at which time he stated he felt much better and ambulated to his vehicle. While monitoring pt stated he was diabetic and didn't have breakfast but ""felt better"" after some juice and blueberry muffin cookies.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/07/2021,02/07/2021,0.0,PVT,Metformin,,DM 2,,"Shrimp and ""some kind of pain med""",['Dizziness'],1,PFIZER\BIONTECH,IM 1047290,PA,74.0,M,"Got shot at 1:30 pm. at 1:45 started to have sensation of throat closing. I took a benedryl. Drove home, about an hour away. During the drive home, experienced lip swelling and throat swelling. Went directly to Hospital ER at 2:45 pm. I was given dexAMETasone, diphenhydrAMINE, andfamotidine. Swelling went down, and I went home about 4:00 pm. I had no problems at home. I saw my family doctor the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,UNK,"allopurinol, simvastatin, levothyroxine, januvia, baby aspirin",none,"hypertension, hypothyroidism, type II diabetes",,none,"['Lip swelling', 'Oropharyngeal discomfort', 'Pharyngeal swelling']",1,MODERNA,IM 1047291,CA,22.0,F,"tiredness in the arm, tingiling, reoccurring numbness (goes away and comes back)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,PHM,centrum vitamins,none,asthma,,none,"['Fatigue', 'Hypoaesthesia', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 1047292,OH,67.0,F,"2nd day extreme muscle and joint ache, fatigue, fever 99.9 3rd day hives on chest, abdomen and back, but otherwise felt fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PVT,"Estradiol patch, Xiidra, ALEVE, diphenhydramine, Allegra, Pantoprazole, Calcium, fish oil, zinc, vitamin C, Vitamin D",none,arthritis,,none,"['Arthralgia', 'Fatigue', 'Myalgia', 'Pyrexia', 'Urticaria']",1,MODERNA,IM 1047293,CA,48.0,F,"swollen of the lymph node, pain on left arm that radiates to upper back",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/18/2021,3.0,WRK,"vitamins, singular",,asthma,,morphine,"['Back pain', 'Lymphadenopathy', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 1047294,IL,47.0,M,"WEAK, CHILLS, JOINT PAIN, SORENESS, AND CHEST PAIN.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/27/2021,01/28/2021,1.0,OTH,,,,,,"['Arthralgia', 'Asthenia', 'Chest pain', 'Chills', 'Pain']",1,MODERNA,IM 1047295,CA,49.0,F,"Headache, nausea, chills, flu-like symptoms, warm, body/muscle ache, sinus",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/20/2021,1.0,SEN,Sertraline (Zoloft),None,None,,None,"['Chills', 'Headache', 'Influenza like illness', 'Myalgia', 'Nausea', 'Pain', 'SARS-CoV-2 test negative', 'Sinus disorder', 'Skin warm']",2,MODERNA,IM 1047296,,65.0,M,Moderna COVID 19 Vaccine EUA Experienced equilibrium issues for two days (during the day) stability issues walking ? at night dizziness ? room spinning. Subsided after two days.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/25/2021,01/26/2021,1.0,UNK,,,,,,"['Balance disorder', 'Dizziness', 'Gait disturbance', 'Vertigo']",1,MODERNA,IM 1047297,OR,43.0,F,"Moderns COVID-19 Vaccine EUA Upon injection, the site was very sore for 3 days with fever chills and then went away. On day 11 i developed covid arm with a large circular welt that was itchy and extremely hot. On day twelve until still today I have a slight rash with extreme itching, sore muscles, sore joints (all my joints), and fever/chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/16/2021,10.0,OTH,Levathyroxine,None,"Hypothyroidism, hashimotos",,"Morphine, Sulfa Drugs, Adhesive","['Arthralgia', 'Chills', 'Injection site pain', 'Myalgia', 'Pruritus', 'Pyrexia', 'Rash', 'Skin warm', 'Urticaria']",1,MODERNA,IM 1047299,NY,64.0,F,"I developed a severe rash that traveled throughout my body after receiving the second dose of the Covid-19 vaccine. It started 3 days after the dose as a rash and within 12 hours it spread to hives and then covered my entire chest, back, neck, arms and face - my ears became swollen. Over the course of several days, the rash spread down my torso and down my legs. The rash turned black and blue in certain areas. It was very itchy. I was seen at Hospital ER, seen by a dermatologist,seen by an allergist and seen by my primary care phsyician. I was treated with prendisone, Hydroxyzine, Benadryl and Zyrtec. I was required to get blood work to check my platelets and liver. Doctors report that this was an allergic reaction. After the one week the rash subsided, and at this time although it is not fully resolved, the rash does not make me uncomfortable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/10/2021,4.0,PUB,none,none,none,,hay fever/pollen & cats,"['Biopsy', 'Hypersensitivity', 'Liver function test increased', 'Platelet count', 'Rash', 'Rash pruritic', 'Skin discolouration', 'Urticaria']",2,PFIZER\BIONTECH, 1047300,TX,50.0,M,"I had body aches, fever, sore throat and runny nose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/11/2021,4.0,PVT,No,No,No,,No,"['Influenza virus test positive', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'Rhinorrhoea', 'SARS-CoV-2 test negative', 'Streptococcus test']",2,PFIZER\BIONTECH, 1047301,OH,58.0,F,"Pt began to fell dizzy about one minute after her injection. Patient remained at vaccine table. Denies any additional symptoms. Dizziness resolved after 5 minutes, vitals declined.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PUB,Declined,None,None,,NKA,['Dizziness'],UNK,PFIZER\BIONTECH,IM 1047302,CA,61.0,F,"patient reported: Mild headache after the vaccine, Headache resolved after 1-2 d After 2 days of vaccine she started feeling right leg heaviness (whole leg) , she was dragging when she walks But no visible swelling, pain, redness per patient, She states at that time she was able to stand and move leg fine but only when she walks she needed to drag No facial weakness , upper extremities symptoms . Had slurry speech intermittent for 1 week after vaccine (Currently none) Lasted for 2 weeks, then resolved completely. after that no symptoms at all. Now Waking fine, no facial weakness, no extremities weakness She did not call us at that time as she thought it is side effect of covid vaccine and thought it would go away. When she went for covid vaccine #2, they said she needs to contact primary care physician due to some symptoms after first vaccine,. then she called us for an advise. by the time she called, no symptoms of neurology. MRI brain: did not show any abnormalities Discussed with local Infectious disease specialist: not sure those were vaccine related or not, recommended to report.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,PVT,"HCTZ, LOSARTAN, ATENOLOL, ADVAIR HFA, SIMVASTATIN, PROAIR PRN",NONE,"chronic medical problems: Hypertension, Hyperlipidemia, Prediabetes, Chronic HEp B , controlled asthma",,"Amlodipine: water retention amoxicillin: Rash Lisinopril: cough Olmesartan: water retention caffeine: elevated bp, chest pressure, dizziness","['Dysarthria', 'Gait disturbance', 'Headache', 'Limb discomfort', 'Magnetic resonance imaging brain normal']",1,PFIZER\BIONTECH, 1047304,IL,47.0,F,"After eating peanuts and peanut butter with no problems for my whole life, I had an allergic reaction to peanut butter on 2/9. I tried peanuts two more times to confirm, and I am indeed suddenly allergic to peanuts. I do not know if this has any relationship to the vaccine, but I was advised to report my experience here.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,02/09/2021,11.0,PUB,"Duloxetine, 60 mg per day; daily multivitamin.",None.,Joint pain from hypermobility.,,Allergic to walnuts and pecans.,"['Food allergy', 'Hypersensitivity']",UNK,MODERNA, 1047305,MT,54.0,F,"Headache, Body Aches, Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Chills', 'Headache', 'Pain']",2,MODERNA,IM 1047306,CA,65.0,M,"started at 2 in the am I woke up with headache and nausea lasting all day, I tried alternating tylenol and ibuprofen didn't help. EOD I was having severe body aches chills headache and nausea no fever, Saturday symptoms were worse, saturday night i added vomitting and temp spiked 101.3 or something like that. Continued low grade temp through wednesday running 99.3 99.8... and I didn't not work those days I stayed home, I was tested for covid and came out negative, I worked thursday and Friday and for the next week I continued with a low grade fever, I went to my primary after and he said it was most likely a reaction to the vaccine. 3 weeks total until I was back to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,"lisinopril 40mg daily, amlodipine 2.5 mg daily, omeprazole 20mg (1 on mon and thurs only), Montelukast 10mg 1 every evening, Ambien 5mg at bedtime as needed, fish oil 1000 mg, metamucile 3 capulses daily, miralax 17 grams evenings, aspririn",no,"hypertension, heart arrhythmias, IBS gastritis with constipation, hernia, arthritis stenosis of the neck, arthritis in both shoulders, osteoarthritis left hand, migraines, exercise induced asthma, tenitis, bilateral radial ulnar nerve impingement in both elbows,",,"penicillin, sulfa, tetracycline, red dye, cow dairy, soy, wheat/gluten, regalan","['Chills', 'Headache', 'Impaired work ability', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting']",2,PFIZER\BIONTECH,SYR 1047308,NJ,40.0,F,?Covid arm? Red and itchi area around the vaccine application area.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/22/2021,8.0,PHM,Venlafaxine Methimazole Vitamin C Magnesium vitamin D Zinc Iron Fish oil,Graves Desease,None,,None,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,SYR 1047309,MN,44.0,F,"On day 12 (February 20), patient noticed some pain under her left bra strap (below the clavicle). On day 13 (February 21), she noticed a bump about the size of a pea under the clavicle. At the injection site, she described her arm as being a little blotchy, sore and mildly swollen but it does not itch. She also felt a little tired and had a mild headache. She took a nap and felt better. On day 14 (February 22) the injection site reaction continues and the pea-sized bump under the bra strap (under the clavicle) remains, and the whole left side of the breast feels a little achy. Patient wants to get dose 2 and plans to request it be administered in the right arm instead.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/20/2021,12.0,PUB,"takes vitamins and brupropion, paroxetine, lisinopril",,,,"erythromycin and amoxicillin, peanuts and environmental dust","['Breast pain', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site reaction', 'Injection site swelling', 'Myalgia', 'Rash macular', 'Swelling']",1,MODERNA,IM 1047310,,61.0,F,"Pt experienced vomiting, fever (101f), diarrhea, headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/01/2021,,PHM,,,,,,"['Diarrhoea', 'Headache', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 1047311,IL,55.0,F,"HEADACHE, BODY ACHES, CHILLS, AND VOMITING.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/27/2021,01/28/2021,1.0,OTH,,,,,,"['Chills', 'Headache', 'Pain', 'Vomiting']",1,MODERNA,IM 1047312,CA,16.0,F,Received vaccine at the age of 16 and 11 months.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,SCH,None.,None.,None.,,None.,['Product administered to patient of inappropriate age'],1,MODERNA,IM 1047313,AZ,36.0,F,"Swollen/tender to the touch face. Specifically under the eyes, cheeks, and chin. It hurts to smile. Started at 4 am 1.5 days after 2nd dose. Also a light bloody nose at 8 am less than 48 hrs after shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/22/2021,2.0,SEN,None,None,None,,None,"['Epistaxis', 'Pain', 'Pain of skin', 'Swelling face']",2,MODERNA,SYR 1047314,WY,56.0,M,About 5 minutes after the shot my tongue went numb for about 40 minutes and then it started to tingle.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/18/2021,0.0,OTH,Reliv vitamins,None,None,,None,"['Hypoaesthesia oral', 'Paraesthesia oral']",1,MODERNA,SYR 1047315,OH,66.0,F,Pt states severe pain in right inner elbow and outer breast. Pain and tingling started in left arm and hand as well.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/13/2021,0.0,PUB,Unknown,Unknown,Unknown,,Unknown,"['Arthralgia', 'Breast pain', 'Pain in extremity', 'Paraesthesia']",UNK,PFIZER\BIONTECH,IM 1047316,MA,65.0,F,fever with delirium including visual hallucinosis - unclear duration approximately 6 hours - unable to confirm detail was back to usual state of health following day when she awoke,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,OTH,"? lorazepam (ATIVAN) 0.5 MG Tablet, 1 TABLET ( 0.5MG ) UP TO TWICE DAILY IF NEEDED FOR ANXIETY, ? Acetaminophen 500 MG Capsule, Take 2 Capsules by mouth every 6 hours as needed for fever or pain ? Baclofen 5 MG Tablet, Take 1 Tablet by",,"fibromyalgia, lumbar disc disease, PVD, smoker, asthma major recurrent depression with anxiety epileptic and non epileptic seizure disorder, frontal cortical dysplasia, history of breast cancer",,"cephalosporins , penicillins - fever pregabalin - severe mood changes and ""purple hands""","['Blood test', 'Delirium febrile', 'Hallucination, visual', 'Urine analysis normal']",2,MODERNA,IM 1047317,MT,40.0,F,Swollen Lymph Nodes,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,PVT,,,,,,['Lymphadenopathy'],2,MODERNA,IM 1047318,TX,71.0,F,"About 18 hours after 2nd COVID vaccine, patient developed sudden loss of hearing in the right ear, accompanied by tinnitus and vertigo and feeling of fullness in the right side of her head.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/14/2021,02/15/2021,1.0,OTH,"atenolol, benazepril, zetia, metformin, glimepiride, famotidine, aspirin",,"HTN, DM, HLD, GERD",,"latex, actos","['Audiogram abnormal', 'Deafness unilateral', 'Ear, nose and throat examination normal', 'Head discomfort', 'Sudden hearing loss', 'Tinnitus', 'Vertigo']",2,MODERNA,IM 1047319,CO,72.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA: immediately after receiving vaccination patient reported dizziness, tremors, diaphoresis, and numbness and tingling of legs. Medical emergency team called to evaluate patient. Vital signs checked four times throughout observation period and all were within normal ranges. Patient's symptoms improved with food and juice and able to leave vaccine clinic for home asymptomatic and stable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/13/2021,0.0,PVT,"multivitamin, venlafaxine, garlic tablet, rivaroxaban",None known,"prediabetes, hyperlipidemia, history of deep vein thrombosis and pulmonary embolism, hypothyroidism, non-small cell lung cancer, history of stroke, history of transient ischemic attack",,None known,"['Dizziness', 'Hyperhidrosis', 'Hypoaesthesia', 'Immediate post-injection reaction', 'Paraesthesia', 'Tremor']",1,PFIZER\BIONTECH,IM 1047320,IN,43.0,F,Parosmia foul smelling odors no one else smells that makes me very nauseous,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/13/2021,02/19/2021,6.0,UNK,,,,,,"['Nausea', 'Parosmia']",1,PFIZER\BIONTECH, 1047321,MA,60.0,M,"Seen in ED,Patient will with reports of a globus sensation in his throat that started this afternoon 2/18, Patient with some inflammation of the uvula with mild erythema.Concern for old allergic reaction versus uvulitis. Pt has no other associated symptoms. Patient was treated with oral Decadron however spit this out, was then treated with IM Decadron. No other symptons. At time of discharge pt was asymptomatic.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,PUB,"Lisionopril,ASA,Chlothalidne, Lipitor, Polyvinyl alcohol 1.4 % ophthalmic soln.",none,"S/p CABG, CAD, HTN, Hyprlipidemia, Obesity BMI 35.0-39.9, GERD, colonic polyp, Rt remnal massmass,SVT, Retinopathy",,Metoprolol intolarence : Erectil dysfuncton,"['Inflammation', 'Pharyngeal erythema', 'Sensation of foreign body', 'Streptococcus test negative']",1,MODERNA,IM 1047322,AZ,17.0,F,"Pt 17 yrs old. Clinic required 18+ , no other adverse reactions.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/14/2021,02/14/2021,0.0,SCH,,No,,,No,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 1047323,TX,80.0,F,Arm got red 2 days after injection stayed just a small red spot untilweek later and now it's a blotchy red and white spot about 2X3 inches.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,OTH,Evista Enalapril/HCTZ Fluticasone Zolidem Pantoprazole Multi vitamin,None,Ostprosis,from Pneumonia,None,"['Injection site erythema', 'Injection site rash', 'Rash macular']",1,MODERNA, 1047325,SC,67.0,F,"Twelve hours after receiving the second Covid injection, I had severe chills, night sweats, mild fever, general weakness, and malaise. The symptoms gradually subsided the next 12-24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PUB,"20 mg. Escotalipram, multi vitamin, collagen, B-12, C & D.",None,"Meningioma, Achilles Tendonitis, Gilbert's Disease.",,Allergic to percocet. Dosage sensitivity to codeine and other meds. No food allergies.,"['Asthenia', 'Chills', 'Malaise', 'Night sweats', 'Pyrexia']",UNK,MODERNA,IM 1047326,MI,96.0,F,"According to patient's caregiver, patient presented with symptoms of fever (101.6 F) and purple blotches all over the body within an hour. Since patient was in hospice , caregiver called Hospice and a pharmacy and was told to give patient Benadryl and Tylenol. Patient was given both medications and the fever subsided in a few days but the purple blotches never went away. Patient passed away at the facility a week later.",Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,SEN,"Namenda, Aricept, Multivitamin, Glucophage, Creon",Decubitis Ulcer,"Diabetes Mellitus Type 2, TIA (never diagnosed per Caregiver)",,Penicillin,"['Death', 'Pyrexia', 'Rash macular']",1,MODERNA,IM 1047327,IL,58.0,F,"HOTNESS, SWELLING OF LEFT ARM, AND PAIN IN NECK.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/19/2021,02/03/2021,15.0,OTH,,,,,,"['Neck pain', 'Peripheral swelling', 'Skin warm']",1,MODERNA,IM 1047328,AZ,26.0,F,"Individual comes to mass vaccine administration clinic .Consent form and risks were reviewed with the individual prior to receiving vaccination. Individual received 1st dose of Moderna Vaccine, Lot # 015M20A, NDC 80777-273-10, 7/29/21 expiration. Individual was given 0.5ml of Moderna Vaccine IM and then escorted to waiting room for monitoring for 30 minutes. Individual had no reactions to the vaccine or complaints but after 13 minutes at 3:53 pm she started with a seizure and was unconscious. 911 was called and her vitals monitored. 3:59 pm pulse 62, O2 98%, BP 125/77 blood sugar 77.Smelling stick was used and individual slowly woke up. Staff from the center she came from came over and states that individual does have a history of seizures. Paramedics on the scene asses individuals vitals and share that she had a seizure and left since individual signed not to go to the hospital 4:05 individual took a clonaepam 0.125 from her purse and took it po. Individual remained stable and alert 4:14 individual was assessed again vital 110/83, pulse 60, O2 96% Patient was stable the rest of her 30 minutes post vaccine administration individual left stable with staff. Individual motioned that she was feeling better since she does not speak Individual was given follow up vaccine appointment in 30 days but was told she needed to get a note from her provider that she is able to have a second vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,OTH,patient is taking prescription medication - we do not have a list of her medication. She is not our patient. She attended a mass vaccine clinic here,hx of seizures per clinic driver she came with unknown rest of medical history,seizures unknown rest of medical history,,unknown,"['Loss of consciousness', 'Seizure', 'Speech disorder developmental']",1,MODERNA,IM 1047329,FL,70.0,F,"itchy pink rash at site of injection, rash size approximately 5 inches by 3 inches",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/22/2021,10.0,UNK,rosuvastatin- 10mg calcium- 500mg,none,CLL,,none,"['Injection site pruritus', 'Injection site reaction', 'Rash erythematous']",UNK,MODERNA, 1047330,AZ,45.0,M,"Patient received his first dose on 2/1/21 and was observed for 15 minutes. He reported that after returning home he has dizziness and weakness that lasted 45 minutes and then resolved without treatment. He did not seek care. On the day of his second shot (2/22/21) he said he had not taken his blood pressure medication that morning. His blood pressure was143/98 and pulse 70 prior to vaccination. At 10 minutes after the injection he reported feeling dizzy and having shortness of breath and feeling dry mouth. His O2 sat was 98%. Pulse had increased to 82 and then several minutes later was 110. He was placed on a monitor but a large size cuff was not available at the vaccination site. He continued to feel weak and more short of breath, so he was given a dose of epinephrine by autoinjector and EMS was called to transport him to the ER. At the ER, he was given diphenhydramine and his condition continued to improve. He was observed in the ER for 3 hours and discharged home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PVT,"amlodipine, lisinopril, omeprazole",none,"hypertension, GERD, obesity",,None,"['Blood potassium decreased', 'Blood sodium decreased', 'Dizziness', 'Dry mouth', 'Dyspnoea', 'Heart rate increased', 'Troponin normal', 'White blood cell count normal']",2,PFIZER\BIONTECH,IM 1047331,AR,94.0,F,ADMINISTRATION OF THIRD DOSE BY NURSING HOME STAFF,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,SEN,,,,,,['Extra dose administered'],3,MODERNA,IM 1047332,MT,50.0,F,"05:00 pm slept 15 hours over night. Slept through 2 alarm clocks. Arrived at work on time but cognition was significantly slower all day. Brain got tired with mild headache after 7 hours on shift and went home early, due to could not mentally function to complete work shift.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,OTH,"tri-cyclen birth control, B-complex vitamin, coconut oil capsules",none,"latent asthma, aspergers syndrome",,"garlic, onions, dust, pollen","['Gait inability', 'Headache', 'Hypersomnia', 'Mental fatigue', 'Respiratory tract congestion']",2,PFIZER\BIONTECH,SYR 1047333,,81.0,M,"Chills, headache, tiredness for 30 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/22/2021,1.0,MIL,blood pressure medicines,none,"osteoarthritis, high blood pressure, herniated back disks, prostate cancer",,none,"['Chills', 'Fatigue', 'Headache']",1,MODERNA,IM 1047334,,73.0,F,"Mildly itchy vaccination site, face, and hands. This lasted approximately 2 days. I also noticed a rash developed (apx 4""X3"") at the vaccination site. The rash is now, (6 days later) reduced significantly.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/17/2021,13.0,PVT,"Triamterene, HCZ, Atenolol, Paroxetine, simvastatin, tramadol as needed Calcium, vitamin D, krill oil 9omega 3), 81 mg aspirin",none,high blood pressure & high cholesterol both controlled with medication 2X breast cancer survivor,,Penicillin,"['Injection site pruritus', 'Pruritus', 'Vaccination site rash']",1,MODERNA,SYR 1047335,FL,73.0,F,"Red, warm rash at injection site 8 days following vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/01/2021,02/20/2021,19.0,UNK,Levothyroxine Atorvastatin Citalopram,None,Thyroid High cholesterol,,None,"['Injection site erythema', 'Injection site rash', 'Injection site warmth']",UNK,MODERNA,SYR 1047336,NY,48.0,M,"Headache, nausea, light sensitivity, muscle aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,OTH,Telmisartan and Omeprozold,None,High Blood Pressure,Flu Vaccine,None,"['Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Photophobia']",2,MODERNA, 1047337,TX,60.0,F,"Feeling flush, dryness in throat, tongue feeling thick. Dr. evaluated client. Assessed and noted lungs to be clear. No medication additionally given. Client observed for extra 30 minutes. Patient was noted to feel better and released out to family.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,PUB,,None,None,,None,"['Dry throat', 'Flushing', 'Tongue disorder']",1,MODERNA,IM 1047338,CO,77.0,F,"Chills, slight fever, fatigue on 2/17/2012, mild achyness, fatigue 2/18/21. Rash on inside of left arm lasted 3 days after injection . Took ibuprofen to help relieve symptoms. Soreness and tenderness at injection site lasting 4 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PVT,,,,Soreness at injection site with all flu vaccines,,"['Chills', 'Fatigue', 'Injection site pain', 'Injection site rash', 'Pain', 'Pyrexia']",2,MODERNA,IM 1047339,MI,72.0,F,Noticed large rash on left upper arm on Feb. 21 about 10 pm. On Feb. 22 still a rash but doesn't seem to be any larger. Minor warm feel to the area. Haven't really done anything to treat other then some Neosporin ointment.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/21/2021,13.0,PVT,"Vitamin D (1,000IU), Potassium 99mg, Tylenol Pravastatin 40mg Hydrochlorothiazide 25mg Diltiazem ER 240mg",none,high blood pressure,,none known,"['Injection site rash', 'Skin warm']",1,MODERNA,IM 1047340,MO,36.0,F,"Pt reported nausea/vomiting, headache after first dose",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,02/22/2021,32.0,PHM,,,,,,"['Headache', 'Nausea', 'Vomiting']",1,MODERNA,IM 1047341,WY,54.0,F,"At 1333 I was called to lobby. Upon arrival, pt states she is feeling light headed and dizzy. VS 108/68, 97.6, RR 16, o2 98% on RA, and HR 45. Pt AOx4. Pulses thready. Patient?s skin is moist and clammy. Called for a WC and took pt to exam room where she sat in a reclining chair. VS taken every 5 minutes. She kept mentation through her stay. She states she felt slightly nauseated but was able to hold down water. VS started to improve once she was reclined in exam room. Education provided about f/u with PCP as HR fluctuated between 57-85. Educated about monitoring for symptoms the rest of the day and when to go in for evaluation is symptoms reappear. Pt verbalizes understanding. At 1400, pt states she is feeling better and feels well enough to leave facility. She has no one in town to come get her. VS= 02 98% HR 60, T97.8, BP 120/74, RR 16. Time of leaving, pulses were strong and equal, cap refill WNL. Will call at 1700 for F/U call.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,NONE,NONE,TAKES LISINOPRIL FOR HTN,,"""SOME FRUITS""","['Cold sweat', 'Dizziness', 'Nausea', 'Pulse abnormal']",2,PFIZER\BIONTECH,IM 1047342,CA,64.0,F,"This issue happened 1 1/2 weeks after receiving my 1st vaccine. I have redness around injection site, itchy and hard to the touch. Upper arm is a little sore. I did not have any reaction until now.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/20/2021,11.0,PHM,none,none,none,,none,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Pain in extremity']",1,MODERNA,SYR 1047343,IL,68.0,F,"1 week after injection, February 10th, 2 itchy red spots appeared on back of left thigh. Thought they were bites, as I had no other symptoms. The itching and size of spots increased over a week, but did not find blisters until February 17th. Saw Nurse Practitioner on Feb. 18th, who sent swab to lab for verification of Shingles and started me on antiviral, valACYclovir (Valtrex), for 7 days. By Feb. 21. no new outbreaks, and 2 of 4 areas of outbreak were drying.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/17/2021,14.0,PVT,,none,Diabetes,,,"['Herpes zoster', 'Rash erythematous', 'Rash pruritic', 'Rash vesicular', 'Varicella virus test positive']",1,PFIZER\BIONTECH,IM 1047344,AZ,17.0,F,"Pt Age is 17, Clinic age requirement 18.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/13/2021,02/13/2021,0.0,SCH,,No,,,No,['Product administered to patient of inappropriate age'],1,MODERNA,IM 1047346,AZ,42.0,M,"Within 3 days of receiving the vaccine develops symptoms and findings consistent with subacute thyroiditis. Pain in the neck area, clear evidence of hyperthyroidism.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,12/26/2020,3.0,PUB,,,,,,"['Blood thyroid stimulating hormone increased', 'Hyperthyroidism', 'Iodine uptake decreased', 'Neck pain', 'Thyroiditis subacute', 'Thyroxine free decreased']",1,PFIZER\BIONTECH,IM 1047347,,24.0,F,Pt reported being dizzy/light headed day after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/01/2021,,PHM,,,,,,['Dizziness'],1,MODERNA,IM 1047348,CA,34.0,M,"My muscles were stiff the next day. On 12/24/2020, while playing tennis, I completely tore my achilles.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,WRK,None,None,I'm Healthy,,None,"['Musculoskeletal stiffness', 'Tendon rupture']",1,MODERNA,SYR 1047349,OH,40.0,F,"Patient felt light headed 5 minutes after receiving the vaccine. Patient had an episode of syncope, which was attended by EMS. Patient regained consciousness within 30 seconds of episode. Patient has had previous episodes of syncope, but not with vaccinations. All vitals were normal when checked by EMS. Her BG was 121 mg/dl. Patient recommended to go to the hospital to get checked out but patient refused. Waited for husband to come pick her up - 5:45pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,WRK,,,,,"Bactrim, Cipro, Zithromax, Trimox, Coconut","['Condition aggravated', 'Dizziness', 'Loss of consciousness', 'Syncope']",1,PFIZER\BIONTECH,IM 1047351,OK,55.0,M,"Patient was tested for covid on 2/2/21 with positive resulted. Presented to Hospital ER on 2/10/21 with c/o of abdominal pain. Diagnosed with gastritis, prescribed metoclopromide and famotidine and dc home. Returned to ER on 2/13/21 with c/o of weakness, diarrhea, foot ulcer, and loss of appetite. Diagnosed: 1) Dyspnea and hypoxia secondary to Covid-19 2) Extensive bilateral lung infiltrates secondary to Covid-19 3) Increased Cr 4) Increased LFTs, ferritin, d-dimer, troponin secondary to Covid-19 5) Elevated procalcitonin placing the patient at high risk for sepsis 6) Chronic appearing Right foot wound without signs of secondary infection Patient transferred to a different hospital in another city.",Yes,02/17/2021,Not Reported,Yes,4.0,Not Reported,N,01/29/2021,02/17/2021,19.0,PVT,"2/10/2021: Metoclopromide, Famotidine, 2/13/2021: Remdesivir, Lovenox, Azithromysin, Meropenem",Covid-19 positive on 2/2/2021,"Diabetes type 2, Hypertension",,"Morphine, Zosyn, Piperacillin","['Abdominal pain', 'Asthenia', 'Blood creatinine increased', 'COVID-19', 'Decreased appetite', 'Diarrhoea', 'Dyspnoea', 'Fibrin D dimer increased', 'Gastritis', 'Hypoxia', 'Limb injury', 'Liver function test increased', 'Lung infiltration', 'Procalcitonin increased', 'SARS-CoV-2 test positive', 'Serum ferritin increased', 'Skin ulcer', 'Troponin increased']",1,PFIZER\BIONTECH,IM 1047352,MN,38.0,F,"Itchy, red, hard bump appeared",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PHM,,,,,,"['Erythema', 'Pruritus', 'Rash']",1,MODERNA,SYR 1047353,AL,79.0,M,Upper respiratory infection 26 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/28/2021,2.0,PVT,"multivitamins, B12, coumadin, torsemide, KCl, magnesium, bisop",none,type 2 diabetic; atrial fibrillation; blood pressure; essential tremor,cholera vaccine 1972,tavist-D(migraines) ; statins; Pacerone(Amioderone),['Upper respiratory tract infection'],1,MODERNA, 1047354,AL,69.0,F,Patient received first dose of Pfizer Covid vaccine at 13:00 at vaccination clinic on 2/21/2021. Patient began to complain about feeling tired and wanted to take a nap later in the afternoon. Patient's husband found patient at 16:30 almost unresponsive and checked a BG reading which resulted at 25. Husband gave patient oral forms of sugar and transported to ER where he BG slowly normalized. Husband reports patient has been a well controlled diabetic and has never has an incident like this happen previously.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,PVT,Diabetic medications,,Diabetes,,Unknown,"['Blood glucose decreased', 'Fatigue', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 1047355,SC,29.0,F,Vertigo. Sporadic onset. Anywhere from 1-5 minutes. Head fog lasting longer,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,MIL,None,None,None,,None,"['Feeling abnormal', 'Vertigo']",UNK,MODERNA, 1047356,CA,49.0,F,"Had 2 days of arm ache, chills, muscle aches & joint aches until 2/14/21. Then on 2/17/21 experienced severe joint ache & muscle aches to the point of tears, lasted until 2/19/21, then back to baseline late Friday into Sat. 2/20/21. Self treated with rest, heating pad, and Aleve.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/13/2021,1.0,PVT,,,,,,"['Arthralgia', 'Chills', 'Myalgia', 'Pain in extremity', 'Tearfulness']",2,MODERNA,IM 1047357,OH,63.0,F,"Sudden numbness, dizziness on and off, numbness receded. Pt encourage to stay but refused and left facility. Instructed to follow up with PCP. 1520 BP 108/58, HR 76, OSat 98% 1540 BP 110/64, HR 76, OSat 97%",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,OTH,,,,,,"['Dizziness', 'Hypoaesthesia']",UNK,PFIZER\BIONTECH,IM 1047358,FL,83.0,F,Patient developed severe gout in L foot 3 days post vaccine. Seen in office and treated. Hadn't had episode for 30 years. Was not on chronic gout medication. No other precipitating events. No change in foods or meds.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/15/2021,3.0,UNK,"Metoprolol Succinate 100 mg/day, Vit B12 2500 ug/day, Vit. D 1000 IU/day, Ofloxacin eyedrops prn.",None,Uncomplicated hypertension; macular degeneration.,,None,"['Blood uric acid', 'Gout', 'Red blood cell sedimentation rate']",UNK,MODERNA,IM 1047359,MN,67.0,F,Hives at site of injection 8 days later - headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/18/2021,8.0,PVT,"Levothyroxine, Ocuvite, Vit K2, Vit D, Quercetin",None,None,,Sulfa,"['Headache', 'Injection site urticaria']",1,MODERNA,IM 1047360,HI,60.0,F,"onset slightly itchy, redness and swelling applied ice pack",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/17/2021,7.0,OTH,"Multi Vitamin, Fish Oil",none,none,,none,"['Erythema', 'Pruritus', 'Swelling']",1,UNKNOWN MANUFACTURER,SYR 1047361,NJ,78.0,F,Woke up this morning with a rash that ran from side to side under breast half way to waist and from side of arm pits to top of breasts. Just red but not itchy.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/22/2021,2.0,PVT,"L-Thyroxine, Atorvastatin, Famotidine, Salmon Oil, CO Q10, D3, Probiotic, C, Zatidor,",,Arthritis. Sinus,,PCN - 40 yrs ago Had hives at the time not related to PCN,"['Erythema', 'Rash']",UNK,MODERNA, 1047362,AL,55.0,M,"Rash on upper arm at site of injection. Itchy, redness patch. Lasting 2-3 days so far. Using some topical cream helps.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/20/2021,8.0,PHM,None.,None.,None.,,Had past allergic skin rash reaction to anti-biotic Clindamycin. A specific brand of sunscreen also gave me a similar rash but I was not able to figure out which ingredient caused the reaction.,"['Erythema', 'Injection site rash', 'Pruritus']",1,MODERNA,IM 1047363,SC,29.0,F,Swelling and pain in arm 7 days after Injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,PHM,,,,,,"['Injection site pain', 'Injection site swelling']",1,MODERNA,IM 1047364,TX,62.0,F,"Red, hard, feverish, sore injection site on left arm approximately 4 inches x 3 inches. It began on February 13, 2021, which was 2 days after injection. Redness subsided some, but on day 8 after injection, area became more red, hard, feverish and sore. Also, I have soreness under arm near lymph nodes. I visited my Primary Care Physician today and was prescribed a steroid pack.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/13/2021,2.0,OTH,Toviaz Triampterene Singular Pravastatin 81 mg aspirin Magnesium Zinc Vitamin C Zyrtec Vitamin D3,None,None,,Penicillin Doxycycline Coban,"['Axillary pain', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Pyrexia']",UNK,MODERNA,SYR 1047365,MS,58.0,M,"Client reported almost immediate severe pain at injection site (approx. 11:15 a.m.). Was monitored by RN. At 11:18 BP was 140/90, HR 82. Injection slightly warm to touch. No redness or edema noted. Client denied dizziness, nausea, SOB or other symptoms. At 11:30 BP was 130/92, HR 72. At 11: 35 BP 122/92. No further progression of symptoms. Pt reported she felt fine and was allowed to leave site and instructed to monitor symptoms, report to her provider if pain persists or other symptoms develop.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,OTH,Unknown,Unknown,Unknown,,Unknown,"['Immediate post-injection reaction', 'Injection site pain', 'Injection site warmth']",2,PFIZER\BIONTECH,IM 1047366,IL,51.0,F,"Pt developed rash on chest, tingling in abdominal area, and anxiousness. Pt given zyretec 10mg PO with water, monitored closely for 1 hr. Instructed per Dr. not to have the second dose administered and to discuss with her physician. Symptoms subsided and pt sent home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,OTH,"Lasarton 10 mg daily, asa 91mg daily, vit D",denies,"htn, brain lesions x3",,Hx of anaphylaxis 1 year ago after having a colonoscopy,"['Anxiety', 'Paraesthesia', 'Rash']",1,PFIZER\BIONTECH,IM 1047367,AR,92.0,M,ADMINISTRATION OF EXTRA DOSE BY NURSING HOME STAFF,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,SEN,,,,,,['Extra dose administered'],3,MODERNA,IM 1047368,AZ,41.0,F,"During the 15 minute observation period, pt reported upper lip swelling and hives on face.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,PUB,,,,,,"['Lip swelling', 'Urticaria']",1,PFIZER\BIONTECH,IM 1047369,CA,50.0,M,"Per Observer RN; Caregiver reported feeling ""flushed."" Observer noted facial flushing. Caregiver reported ""blurred vision, itchiness all over body as well as dizziness."" Approx. 10 minutes later also reported ""chills.""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,"Caregiver states on ""Humira.""","Caregiver states HX of ""psoriasis.""","Caregiver states HX of ""psoriasis.""","""flushing,"" 50y.o., 01/22/2021, 1st dose Moderna",NKA to medication,"['Chills', 'Dizziness', 'Flushing', 'Pruritus', 'Vision blurred']",2,MODERNA,IM 1047370,,,U,RED RASH TO BOTHARMS FLEXOR ASPECT AND ABDOMEN TREATED WITH HYDROCORTISONE AND BENDRYL,Not Reported,,Not Reported,Not Reported,,Not Reported,,,,,UNK,,,,,,"['Rash', 'Rash erythematous']",1,MODERNA,IM 1047371,CA,28.0,F,"I had arm soreness the day of the vaccine (2/11/21). The following day I noticed an erythematous round lesion that was very tender and when palpated felt like a lump. The pain went away 2-3 days after the vaccine and the erythema/lump went away on 2/21/21. On 2/19/21 my left internal arm felt sore. I thought I pulled a muscle perhaps. On 2/21/21 the arm pain was worse and didn't feel like typical soreness that would come from exercise or sleeping in the wrong position. It was painful when I pulled my arm close to my body, as if something were being compressed. I palpated in the armpit and found a large lump slightly smaller than a golf ball. It was extremely tender and sent me into a panic. Someone pointed out it was the same arm as my vaccination, so I looked it up and learned about this side effect. Today (2/22/21), the pain is gone and the lump is smaller (feel like a typical enlarged lymph node).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/19/2021,8.0,PUB,None,None,None,,None,"['Axillary mass', 'Lymphadenopathy', 'Mass', 'Pain', 'Pain in extremity', 'Panic attack', 'Rash erythematous', 'Tenderness']",1,MODERNA,SYR 1047372,,63.0,U,"3 weeks after second dose...still extreme malaise, headache and muscle aches I have had the flu shot, and have not been around other individuals that were not also vaccinated",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/05/2021,3.0,PVT,none,type 1 diabetes,type 1 diabetes Graves disease IBS,flu shot 9/2020 not a bad as this,none...although some adverse effects,"['Headache', 'Malaise', 'Myalgia']",UNK,PFIZER\BIONTECH, 1047373,MD,54.0,F,"Hot red rash first appeared behind knees, then on elbows, the on knees and shins, then by sitting bones and then ankles over the course of a week. Prednisone was prescribed and helped.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/10/2021,4.0,UNK,"Claritin, Multivitamin, Vitamin C, Calcium",none,none,,"Milk, Sulfa, Erythromycin","['Rash', 'Rash erythematous', 'Skin warm']",1,PFIZER\BIONTECH,IM 1047374,PA,57.0,F,Swelling and itching at injection site. Seemed to subside but then reemerged a week after vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/22/2021,9.0,UNK,Atorvastatin Muliti Vitamin Vitamin D3 Omega Oil Magnesium,,,Sore Arm,,"['Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 1047375,OR,61.0,F,Not until 2 weeks later I got a very red somewhat itchy and painful arm at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/19/2021,13.0,UNK,"Aripiprazole, Levothyroxine, Bupropion , Propranolol, Montelukast, Vitamin D3, Lamotrigine, Trazaodone, Lorazepam, Omeprazole, Pseudoephedrine, Allertec, Ketacanozole shampoo, Pulmicort , & Stool softener",None,"Back pain, Seasonal Allergies",,Septra,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus']",1,UNKNOWN MANUFACTURER, 1047377,NJ,22.0,M,"Severe chills at night for over 2 to 3 hours. High fever. Woke up next morning and went to get a glass of water, felt dizzy and could not walk. Then vomited water out. Severe congestion.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,PUB,Insulin,,Type 1 Diabetes,,,"['Chills', 'Dizziness', 'Gait inability', 'Pyrexia', 'Respiratory tract congestion', 'Vomiting']",2,PFIZER\BIONTECH,SYR 1047378,AZ,90.0,F,"HIVES ON BILATERAL UPPER AND LOWER EXTREMITIES, CHEST, AND BACK",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,SEN,,,"CAD, CARCINOMA IN SITU OF BREAST, HISTORY OF CARDIOMYOPATHY, HTN, LEFT BUNDLE-BLOCK, PAROXYSMAL ATRIAL FIB, PE, HIATAL HERNIA, HYPERTHYROIDISM",,NSAIDS (NON-STEROIDAL ANTI-INFLAMMATORY DRUG) PENICILLINS ROFECOXIB FOSAMAX BACTRIM LATEX TIDE,['Urticaria'],UNK,MODERNA, 1047379,CA,69.0,M,8 Feb 2021 - blurry vision occurred 9 Feb 2021 - blurry vision and then double vision. Double vision has been 24/7 since the evening of 9 Feb 2021,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/02/2021,,,PVT,"ALLOPURINOL , EZETIMIBE, GEMFIBROZIL","GOUT & HIGH CLOLESTROAL,",JUST THE ABOVE,just upper arm soreness,NO NONE ALLEGERGIES,"['Diplopia', 'Vision blurred']",5,MODERNA,IM 1047380,TX,63.0,M,"Heart palpitations, they lasted from 3 hours after vaccine until the following afternoon, around 26 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,OTH,"I began to have heart palpitations which lasted on and off all evening and into the next morning. When I woke up, I still had them somewhat. Heart rate dropping to 45 bpm and going to 75 (normal resting is 54). After about 10:00 or 11:00",Asthma,I take meds for high cholesterol and to help with heart rate.,,"Achrocidin is a medication I am allergic to, but they no longer make it.",['Palpitations'],UNK,PFIZER\BIONTECH, 1047381,WI,68.0,F,"Patient was diagnosed with Immune Thrombocytopenic Purpura on 2/21/2021. -petechial rash, bruising -Platelets 4 thousand at hospital admission -Patient is receiving prednisone and IVIG with improvements in platelet count currently",Not Reported,,Yes,Yes,,Not Reported,,02/09/2021,02/18/2021,9.0,PVT,"calcium-vitamin D 600 mg-200 u oral tablet: 1 tab(s) PO (oral) qDay ibuprofen 200 mg tab: 2 tab(s) PO q4hr PRN for pain levothyroxine 50 mcg (0.05 mg) oral tablet: 1 tab(s) PO (oral) AsDirected Duration 90 day(s) Take 2 tabs on Mon, Wed,",none,Hyperaldosteronism Hypothyroidism Migraine headache disorder Osteoporosis,,none,"['Contusion', 'Immune thrombocytopenia', 'Immunoglobulin therapy', 'Petechiae', 'Platelet count decreased']",1,MODERNA,IM 1047382,TX,24.0,F,"Some nausea 3 hours after injection, resolved after 4 hours. Sudden severe nausea and vomiting begging 01/27/2021 at 12am (14 hours after vaccination), 2 am, and 4 am. Fever of 101.7 F at 6 am with chills, body aches, and headache, without nausea or vomiting. Treated with 2 x 325mg Tylenol. Fever broke around 12pm 01/27/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/27/2021,1.0,SCH,Amitriptyline 50mg Spironolactone 100mg Sprintec - norgestimate-ethinyl estradiol One-a-day women's multivitamin Fish oil - 1200mg x2,None,Chronic daily headaches,,NKDFA,"['Chills', 'Condition aggravated', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,MODERNA,SYR 1047383,MD,59.0,F,"Two days after I got mouth sores that hurt, inside front lip and on tongue (I believe it was two or three sores, and they lasted about 5 or 6 days.) I share this because I got my second dose 2/17/21 batch EL9266 in left arm and again two days out got sores on my lip and tongue (total of 2 sores that hurt). The one on my tongue has made it hard to swallow, because it is far back on my tongue. I have used a peroxide product to lesson the pain. I am 5 days out from my second vaccine, and the sores are not getting worse and I hope they lesson and go away as the first batch did after about 6 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/23/2021,2.0,UNK,Airbourne supplement and multi vitamin,none,managing high cholesterol,,none,"['Cheilitis', 'Dysphagia', 'Glossodynia', 'Oral pain', 'Stomatitis']",1,PFIZER\BIONTECH,SYR 1047384,CA,52.0,F,"Headaches off and on since vaccine on Feb 2, 2021 with increase in severity since vaccine. This is the first vaccination. Second vaccine is schedule for March 2, 2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/03/2021,2.0,PVT,"Klonopin 1-3 mg daily PRN, Vitamin D-10,000 iu, Vit. C-1000mg, Zinc- 50mg, Glucosamine,",None,"Hepatitis C( undetectable since 2005), Arthritis, Basal Ganglion Cyst in the Hypothalamus, History of Hypertension, (blood pressure under control since losing weight- last B/P on 2/21/21- 119/74) History of Migraines, Adie's Tonic Pupil.",,"PCN( rash), Sulfa( severe rash, itching,), Codeine( tachycardia), Latex( rash), Adhesives from bandages( rash, blisters, tearing of the skin) Lisinopril (rash, itching)",['Headache'],1,MODERNA,IM 1047385,TX,65.0,F,"light headache, shoulder sore, fever, joints aching, sickening headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,UNK,tylenol,,back and knee problems,,sulfur,"['Arthralgia', 'Headache', 'Pyrexia']",2,MODERNA,IM 1047386,LA,71.0,M,"At 11 hours post dose: Oral temp 99.6F. Took Ibuprophen, and temperature returned to normal. At 24 hours post dose: Temperature normal, but sinus drainage and coughing began (similar to seasonal allergies). No medication taken. At 72 hours post dose: Urticaria appeared over one hour on the inside of both arms and legs and scalp. My scalp itched moderately. I took Benedryl 25mg po q6h x 2, then Loratidine 10mg po before bed (No further medication was taken). Coughing and sinus drainage resolved after beginning the antihistamines. The urticaria had resolved on my arms and legs by 96 hours post dose. The scalp itching was resolved in another 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,OTH,"Atorvastatin 40mg po qd, multivitamin capsule po qd",None,Hypercholestrolemia,,NKDA,"['Body temperature increased', 'Cough', 'Paranasal sinus hypersecretion', 'Pruritus', 'Urticaria']",2,MODERNA,IM 1047388,UT,44.0,F,"body aches COVID arm (sore, red, swollen area beneath the injection site)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,WRK,none,none,none,,none,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Pain']",2,MODERNA,IM 1047389,IL,,U,"Sharp pain in neck, fatigue, chills and pain on right side",Not Reported,,Not Reported,Not Reported,,Not Reported,,,,,OTH,,,,,,"['Chills', 'Fatigue', 'Neck pain', 'Pain']",1,MODERNA,IM 1047390,NY,58.0,F,"Swelling, hardness, itching, rash, sore",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/20/2021,9.0,SCH,Claritin,,,,"Sulfa drugs, salmon","['Induration', 'Pain', 'Pruritus', 'Rash', 'Swelling']",1,MODERNA, 1047391,NY,32.0,F,"Lightheaded. Skin was clammy, convulsions started, Epi pen administered, she had tongue swelling, came around then eyes rolled back in head, nausea, blood pressure high.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/15/2021,02/15/2021,0.0,SEN,,,,,,"['Cold sweat', 'Dizziness', 'Gaze palsy', 'Hypertension', 'Nausea', 'Seizure', 'Swollen tongue']",2,PFIZER\BIONTECH,IM 1047392,VA,34.0,F,"Pain at injection arm really sore ""like I was punched in the arm"" then 2 days later started having numbness down arm into the middle and ring Finger of left hand. Constant, notes that in some positions the tingling will go away.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,PVT,None,None,None,,,"['Hypoaesthesia', 'Injection site pain', 'Paraesthesia']",1,MODERNA,IM 1047393,CO,87.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA: soon after receiving vaccination patient reported headache and numbness in both feet and right hand. Twenty minutes after vaccination reported nasal congestion, worsening headache, and not feeling well. Initial vitals within normal ranges except blood pressure 159/85 mm Hg, repeated 15 minutes later at 144/80 mmHg. Medical evaluation team arrived and allergy provider contacted: patient administered oral diphenhydramine. Patient discharged to home from vaccination clinic improved and stable. On scheduled follow-up encounter with primary care provider three days later patient did not report any symptoms from vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/13/2021,0.0,PVT,"ketotifen ophthalmic, albuterol, MAALOX, vitamin C, aspirin, budesonide, calcium carbonate, carboxymethylcellulose ophthalmic, cholecalciferol, conjugated estrogens, diclofenac gel, diphenhydramine, erythromycin ophthalmic, famotidine, guai","weakness, protein-calroie malnutrition","multiple allergies, palpitations, atrial fibrillation, angina pectoris, goiter, vitamin D deficiency, chronic rhinitis, irritable bowel syndrome, gastroesophageal reflux disease, mixed connective tissue disease, degenerative joint disease, fibromyalgia, osteoporosis, peripheral neuropathy, migraines, asthma, chronic obstructive pulmonary disease, lichen sclerosus",,"doxycycline, ipratropium, sulfamethoxazole-trimethoprim, clarithromycin, fluticasone, cefaclor, ciprofloxacin, etidronate, alendronate, iodinated contrast media, peanut, penicillin, trovafloxacin, azithromycin","['Blood pressure increased', 'Headache', 'Hypoaesthesia', 'Malaise', 'Nasal congestion']",1,PFIZER\BIONTECH,IM 1047395,MS,51.0,F,"Client was in parking lot being monitored after injection. Reported to attendant that she felt her throat was tightening. RN's x 2 arrived to assess. At 3:30 BP was 106/62, HR 78. Was administered Benadryl 50 mg po at 3:35 pm. At 3:45 pm BP was 100/78 and HR 72. After approx. 10 more minutes pt reported she no longer felt sensation of throat tightening. RN's continued to stand by. After 10-15 more minutes pt stated she felt fine, did not have far to drive to her home. Was instructed to continue to monitor symptoms. If began to experience throat tightening again, or any other symptoms to seek medical attention immediately; call 911. Client voiced understanding.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,OTH,unknown,unknown,unknown,,,['Throat tightness'],1,PFIZER\BIONTECH,IM 1047396,CA,51.0,F,Received her 1st covid vaccine at noon on 2/19/21. Woke later that night in middle of the night with bleeding from right nostril and severe right ear pain,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,Benadryl,None,None,Influenza vaccine on 10/2018 caused tachycardia,"Penicillin, Sulfa, Iodine, Moxifloxacin","['Ear pain', 'Epistaxis']",1,PFIZER\BIONTECH,IM 1047397,KY,43.0,M,"Around 60 seconds after injection my left arm became heavy and tingly/numb, this then occurred in my right thumb as well. I had a heavy sensation on my chest and my heart rate increased rapidly to over 120. This would then resolve slowly and then the tachycardia would recur with the odd sensation over my whole body every ten-15 minutes. EMS was called to take vitals and monitor me. Very odd feeling. I was monitored over the course of 2 hours and when I finally stood up my legs felt heavy and weak as well. After going home and resting things seemed to resolve and I was even able to go out to dinner that evening. The following week I didn't notice much of anything but new symptoms arose around 6 days later on Friday. I would feel strange feeling in my legs and a heaviness. I had a strange dizziness but not vertigo. I felt like I was in slow motion at times. This worsened and I had weakness/fatigue that reached its peak on 1/20/21 and 1/21/21. I was unable to operate on Wednesday as an orthopedic surgeon and had to cancel cases due to this weakness. I saw my doctor that day and had a battery of tests run. CMP, TSH, T4, T3, COVID, COVID IgG, Epstein Barr, Brain MRI, Neruo Consult, ANA, CK, Flu A/B, Vit B12 level, ESR, CRP, Vit D level, EKG, CXR. The following day when I awoke in the morning I felt extremely lethargic and had to cancel clinic. Over the following weeks things have gradually improved but I occasionally get some dizzy/lightheaded moments.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Synthroid 200mcg daily,,,,PCN/Cephalosporins,"['Antinuclear antibody positive', 'Asthenia', 'Blood creatine phosphokinase increased', 'Blood thyroid stimulating hormone decreased', 'C-reactive protein normal', 'Chest X-ray normal', 'Chest discomfort', 'Dizziness', 'Electrocardiogram normal', 'Epstein-Barr virus antibody positive', 'Fatigue', 'Feeling abnormal', 'Heart rate increased', 'Hypoaesthesia', 'Immediate post-injection reaction', 'Impaired work ability', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Lethargy', 'Limb discomfort', 'Magnetic resonance imaging brain normal', 'Metabolic function test normal', 'Muscular weakness', 'Paraesthesia', 'Red blood cell sedimentation rate normal', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 test negative', 'Sensory disturbance', 'Specialist consultation', 'Tachycardia', 'Thyroxine normal', 'Time perception altered', 'Tri-iodothyronine normal', 'Vitamin B12 normal', 'Vitamin D']",1,MODERNA,IM 1047398,IN,38.0,F,Swollen lymph nodes the size of a golf ball near the breast underarm of the vaccination arm. (Right arm). I called my doctor office and the staff said it can be a side effect but to report it.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/05/2021,2.0,PVT,"Tylenol, vitamin d3, multivitamin",None,"Asthma, vitamin d deficiency, tmj disorder, kidney stones, anxiety, migraines from tmj",,"Milk, chlorhexidine, sulfa",['Lymphadenopathy'],2,PFIZER\BIONTECH,IM 1047399,NY,66.0,M,Late onset (9 days later) rash at the injection site (still present) and (possibly) severe pain at right-sided mid back that lasted one day.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,,,SCH,B-12 & Chlorophyll,None.,None.,,Amoxicillin,"['Back pain', 'Injection site rash']",UNK,MODERNA, 1047400,MI,24.0,F,"I had the following symptoms following my first shot of the COVID-19 vaccination: loss of appetite (lasted for about a week), fever, migraine, extreme fatigue and weakness, body aches, and chills. My left arm also felt very sore for a few days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,OTH,"Synthroid, Xulane birth control patch, Topamax.",None.,Hashimoto's disease.,,No known allergies.,"['Asthenia', 'Chills', 'Decreased appetite', 'Fatigue', 'Migraine', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 1047401,FL,56.0,F,"Moderna Day 2 & 3 - extreme arm pain, headache, body aches Day 4 - headache, nausea, vomiting, diarrhea, abdominal cramps, body aches Day 5 -7 headache, nausea, abdominal cramps",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/18/2021,3.0,PHM,"Dilacor XR, Glipizide XR, ozempic, Triltellix, aspirin, loratadine, vitamin d3, levoxyl, levothyronine, red yeast rice, coq10, montelukast, iron, dhea,","Hypertension, hypo-thyroidism, diabetes II, copd/sleep apnea, depression/anxiety,",As above,,"Tetracycline, codeine, environmental allergies (3 shots/once a month)","['Abdominal pain', 'Diarrhoea', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Vomiting']",2,MODERNA,IM 1047402,IL,70.0,F,it felt like the reaction i generally have had with steroid injections for my spine. I was wide awake all night. By the following afternoon I was exhausted and no longer feeling that effect. Nothing was done since it did not last. It was suggested that I report it since it is not mentioned as a side effect in the list of information.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/13/2021,1.0,PVT,metoprolol 25mg 2x Hydrochlorhiazide 2mg 1x losartan 25 mg 1x omeprazole 20 mg 1x atorvastatin 20 mg 1x Baby aspirin 81 mg 1x Gabapentin 400 mg 3x Hydrocortisone cream 2.5% 2x vitamin D3 2000 iu,none,hypertension,,none,"['Fatigue', 'Insomnia']",2,PFIZER\BIONTECH, 1047404,SD,44.0,F,2nd dose of Moderna given today (2/22/2021) 2 weeks early. Patient had no signs or symptoms of adverse reaction following vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PVT,,,,,,"['Inappropriate schedule of product administration', 'No adverse event']",2,MODERNA,IM 1047405,CA,73.0,F,"Chills, lasting for 2 days, fatigue lasting for 2 days, very sore arm 4 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PHM,no,none,none,,no,"['Chills', 'Fatigue', 'Pain in extremity']",UNK,MODERNA,IM 1047407,FL,65.0,F,"Feeling achy all over body (flu-like) about 8 hours after shot and continued for about 3 days, even soles of feet. Difficulty sleeping that night. Could not sleep on left side for about 3 days. Knees ached, difficulty walking.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,OTH,"Valsartan, levothyroxine, generic zyrtec",,,"Flu shot about 1976 aged 20, details unknown. Mild flu symptoms",Only seasonal allergies,"['Arthralgia', 'Gait disturbance', 'Influenza like illness', 'Insomnia', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 1047408,CA,35.0,U,C/o dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,OTH,Suboxone 12-3mg Sublingual Film docusate 100 mg,under SUD program,SUD,,,['Dizziness'],1,MODERNA,IM 1047409,FL,69.0,M,"Moderna Covid-19 Vaccine EUA After 3 days, upon scratching an itch on my back, I felt bumps on my back and found my back covered with reddish bumps. The itch was slight and increase when scratched. On day 4, upon further examination, I found the same bumps an my front torso and shoulders. All the bumps are prone to mild to moderate itching (not intense).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/19/2021,3.0,OTH,"Prescriptions: Valsartan, Labetolol, Clopidegrel, Indapamide, Atoravastatin, Tamsolosin and Aspirin Allergy meds: Cetirizine hydrochloride, Loratadine Supplements: Omeprazole, Fish Oil, Magnesium, Vitamin D3, Vitamin A, Acidophalus probi",Heart desease,"Heart desease, Treated for prostate cancer in March 2020 with radiation.",,None known,"['Pruritus', 'Rash', 'Rash erythematous', 'Scratch']",1,MODERNA,IM 1047410,CA,77.0,M,Acute stroke 2 days after receiving vaccine. Second stroke 7 days after that despite being started on aspirin and statin,Not Reported,,Not Reported,Yes,2.0,Yes,N,02/10/2021,02/12/2021,2.0,PVT,,,,,,"['Cerebellar stroke', 'Magnetic resonance imaging brain abnormal']",UNK,PFIZER\BIONTECH, 1047411,CA,33.0,U,"Within minutes of vaccination lips tingling, blurred vision, dizziness/vertigo, sweating. Was able to walk to a chair. Vertigo persisted less than 1 hour. Patient reported vaginal spotting after urinating. Was able to ambulate out of clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/18/2021,0.0,UNK,None,None,orthopedic implant,,ingested aloe vera,"['Dizziness', 'Hyperhidrosis', 'Paraesthesia oral', 'Vaginal haemorrhage', 'Vertigo', 'Vision blurred']",UNK,MODERNA, 1047412,MO,57.0,F,"Developed Shingles, approx 7 days after 2nd dose after 2nd dose",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/19/2021,7.0,PVT,,,,,,['Herpes zoster'],1,PFIZER\BIONTECH,IM 1047413,SC,23.0,F,"Chills, fever, body aches, back pain, headache, swollen left axillary lymph node",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,PUB,Sprintec and Fluvoxemine,,,,,"['Back pain', 'Chills', 'Headache', 'Lymphadenopathy', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1047414,CO,39.0,F,The day after receiving the vaccine the patient experienced swelling from the site of the injection upward into her neck and face. Patient took Benadryl which relieved some of the swelling but slight neck edema and anterior cervical lymphadenopathy remains.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,PVT,Labetalol Alodipine Omeprazole Cardura Zofran Reglan Promethazine Melatonin,,End stage renal disease Hypertension,,Atorvastatin,"['Injection site swelling', 'Localised oedema', 'Lymphadenopathy', 'Swelling', 'Swelling face']",2,PFIZER\BIONTECH,IM 1047415,CA,51.0,F,"Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. They asked me what are my allergies and medical history. I couldn't remember - so had brain fog at that time. My left ear, face, and neck (left side of head) is numb at that time. The symptoms were the same for two hours. Memory remained fogged. An hour or so after the incident - I called the advice nurse from medical clinic and I did remember the doctor's name. Pain on head and numbness remained for days. My auto-immune system was stimulated my doctor said. Everything kept cascading down - now I'm on post surgery 9 days and I'm on disability. I went to ER on January 18, I was complaining of left sided numbness, vomiting, headaches. Facial numbness (left), mild headaches. Left sided headache progressed to (similar to prior migraine headaches) migraine like. January 29, I emailed my physicians (in between the 17th and 29th). On the 29th, I went to see the doctor - joints - really swollen and painful and I cannot walk. I was given steroid shots. February 2, - appt with neurologist. February - with Dr. - for painful swollen feet; Feb 10 - appt with Rheumotologist - Feb 10 with Dr - a Specialist - , as well. Right foot is swollen as well as the left foot at this time. Dr. - axperatated the right ankle -he said it was infected. February 11, Dr said I have infected joints and need surgery. They did surgery on February 13th. Dr. the surgeon . Had surgery at medical facility for infected ankle. February 15 - discharged home. Appt with surgeon on the 16th. Appt with Primary on the 19th. Appt with my Rheumotologist today. Discharged - with Home Health care; Physical and Occupational therapist and nursing. I have been on bedrest since discharge. I need maximum care. Tomorrow I have a appt with surgeon to hopefully remove cast and sutures on surgical site.",Not Reported,,Yes,Yes,3.0,Yes,N,01/11/2021,01/11/2021,0.0,PVT,I have 16 - metoprolol- 50 mg bid; Losartin- 50 mg daily; Furosemide 20 mg bid; K-dur - 20 maq - daily; Prilosec 40 BID; cetirizine - 10 mg daily; aspirin 81 mg BID; Singulair 10 mg daily; Flonase - each nostril daily; Metformin 400 mg 2,no,Congested Heart Failure - right sided GERD Asthma Diabetes Tsoriapic Arthritis Hypertension Cardiac - Status post Stent - left interior descending Migraines Status post bacterial arthritis- right ankle and right elbow Cushing syndrome Calculus of kidney Diverticulitis Fatty liver disease Obstructive sleep apnea Allergic Rhinitis,,Ibuprofen - anaphylaxis Viox - anaphylaxis Indicin - hives Provenicin - hive Ulrica - hives Colchicine - hives Alopurinol - hives,"['Arthralgia', 'Arthritis infective', 'Aspiration', 'Autoimmune disorder', 'Bed rest', 'Blood pressure increased', 'Blood test', 'Cast application', 'Chest X-ray', 'Computerised tomogram', 'Disability', 'Feeling abnormal', 'Gait inability', 'Headache', 'Hypoaesthesia', 'Joint swelling', 'Magnetic resonance imaging brain', 'Memory impairment', 'Migraine', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Surgery', 'Suture insertion', 'Vomiting']",2,PFIZER\BIONTECH,SYR 1047416,NY,73.0,M,"Numbess in left arm, wrist and hand",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/13/2021,1.0,SEN,,,,,,['Hypoaesthesia'],1,PFIZER\BIONTECH,IM 1047417,CA,69.0,M,"A bit lightheaded at 1PM and facial itch and rash where I had shved 12 hours prior to vaccine. Arm pain at site at 3PM. Light chills and upper right back stabbing pain 5 PM. EXTREME CHILLS and BODY TREMORS at 11 PM lasting 10 minutes then chills and night sweats till next morning. Occasional upper right back stabbing pain, light chills, headache, facial itch and continued arm pain all next day followed by gastrointestinal purge at 10PM 02/19/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,PUB,Levothyroxine 1.5 mcg,,"PAFIB, IBS",,no,"['Back pain', 'Chills', 'Dizziness', 'Gastrointestinal disorder', 'Headache', 'Injection site pain', 'Night sweats', 'Pain in extremity', 'Pruritus', 'Rash', 'Tremor']",1,MODERNA,IM 1047419,ID,69.0,F,extreme fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,PUB,,,,,,['Fatigue'],UNK,MODERNA, 1047420,OH,42.0,F,"Soreness in my arm the day and night of the vaccine that continued for a couple of days. Then, a week and a day after I received the vaccine, I developed ""Covid Arm"" with the red itchy rash, hot to the touch on the arm where I received the injection. The Covid Arm has faded tremendously but is still itchy and lasted at least 9 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/04/2021,02/12/2021,8.0,SCH,"Blood pressure meds (Spironolactone and Amlodipine), birth control pills, and Claritin D 12 hour.",None,"Metabolic syndrome, psoriasis, high blood pressure",,Sulfa Drugs,"['Injection site reaction', 'Injection site warmth', 'Pain in extremity', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,SYR 1047421,WA,80.0,M,"Muscle aches and pains, fever 100.4 few hours later atrial fib low blood pressure, fall, admit to ED then admit to hospital. Care continuing in hospital at this point.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/20/2021,02/21/2021,1.0,PVT,"Coumadin, Breo, duloxetine, vitamin multi, flomax, calcium with vitamin d, bupropion, metoprol, preserVision, colace, atorvastatin, vitamin B12, trazodone, Tylenol.",Afib Hypertension Anxiety Copd Sleep apnea Headaches migraine,Afib See above,,"Bactrim sulfa, Lisinopril, plavix, chlorothiazide hydrochlorothiazide, other?","['Atrial fibrillation', 'Condition aggravated', 'Fall', 'Hypotension', 'Myalgia', 'Pyrexia']",2,MODERNA,IM 1047422,CA,56.0,F,"Severe headache and light sensitivity which is not on the common list. This lasted 24 hours as severe, then lessened each day. Today I still have a slight headache and light sensitivity. Coworkers had the same experience. This should be on the side effect listing .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,OTH,None,None,None,,None,"['Headache', 'Photophobia']",2,MODERNA,SYR 1047423,WA,63.0,F,"AdVerse Reporting for FIRST DOSE Moderna Vaccine recieved 1/22/21: 1-2 days after usual sore arm. However 13th day after receiving injection I developed severe fatigue, fevers as high as 101.9, shaking, nausea, severe itching. overall feeling of sick. 3 days later it passed. Due to my preexisting conditions I have isolated myself for almost 1 year, followed all protocols, and very rarely out in public. I also recieved flu vaccine. So doubt the symptoms I had could be contributed to flu bug. So since it seemed very odd I am reporting this to CDC. Note: I had 2nd dose 02/19/21. So far only reaction is sore injection site. Should I develop symptoms after several days like the ones I reported after 1st dose, I will report these to this site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,02/13/2021,22.0,OTH,"Eliquis, metformin, corgard, wellbutrin, occasional peptobismal, Rolaids, flexerill, percocet",,Morbid obesity AFIB Asthmatic Severe Arthritis knees & back,,Sulfa,"['Fatigue', 'Injection site pain', 'Malaise', 'Nausea', 'Pain in extremity', 'Pruritus', 'Pyrexia', 'Tremor']",2,MODERNA,IM 1047424,TX,46.0,F,"- Fever 105 + for over 24 hours, from Friday night to Sunday morning. I kept it down to 105 with OTC meds. Sometimes too high for thermometer to read. - Swelling at injection site (and halfway to elbow), soreness. By Monday this was down to about a golf ball, and it resolved in a week. - Fatigue, slept all weekend and was tired but functioning the following week. - Severe joint pain and muscle aches Saturday and Sunday. I took OTC pain relievers. Went to bed. - Blindingly bad migraine Friday night, worse Saturday, and resolving some on Sunday, somewhat responsive to Naratryptin.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,OTH,"Levothyroxin, Gabapentin, Rosuvastatin, Lisinopril, Advair","Breast Cancer, COVID in Jan","Breast Cancer, Migraines, Hashimoto's, Asthma",,"Mango, Latex","['Arthralgia', 'Condition aggravated', 'Fatigue', 'Injection site pain', 'Injection site swelling', 'Migraine', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1047425,WA,71.0,F,"anaphylaxis, Rx w/epi X2",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,OTH,,,,,,['Anaphylactic reaction'],1,PFIZER\BIONTECH,IM 1047426,CO,17.0,F,Vaccine given to 17 year old patient,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/25/2021,0.0,PUB,,,,,,['Product administered to patient of inappropriate age'],1,MODERNA,IM 1047427,KY,73.0,F,"This is not a critical reaction but want to report in order to help build up the information available to healthcare professionals going forward. Morning after chills, neck stiffness, pain back of head left side. Applied heating pad to neck. By late morning I was nauseous , and weak as a kitten. Took a 500 mg Tylenol and slept for about 4 hours. Woke up in a sweat but chills gone and am now able to eat a little bit. Back of head and neck still very sore. The injection site is sore but no rash; right arm seems to have ""phantom pain"" as well ( I experienced this with Shingles shot in December 2020 too).",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/21/2021,02/22/2021,1.0,OTH,Claritin (1x 2/21/21 to prevent allergic reaction) Osteo-Biflex Vit D3 Estyradiol insert 2x/week Refresh tears OTC for dry eyes,Left big toe infection and removal of toenail on 2/2/2021 completed Cephalexin 2/11/2021,Chronic kidney disease by virtue of having only one kidney Monitoring for recurrence of cancer but currently cancer free,Reported 1/11/2021 E-report No. 232196 Rash from 2nd Shingles Shingrix shot,"Propylene Glycol; tincture of Benzoin; carbamates (adhesives) Cipro, Biaxin, maybe Amoxicillan Dust, dander, mold, some grasses","['Asthenia', 'Chills', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Musculoskeletal stiffness', 'Nausea', 'Neck pain', 'Phantom limb syndrome']",1,PFIZER\BIONTECH,SYR 1047428,WY,89.0,F,"During screening for the vaccine at a mass clinic, ct said she had 'too many allergies' to list. RN escorted client to the local hospital and gave her the COVID vaccine there so she could be monitored there. Two hours after client received vaccine when she was at home she became very itchy, was uncomfortable for 4 days, stated this happens to her all the time. Then was ok. 02/03/2021-ct reported PCP told her not to get the second dose of Moderna to wait until the other brand vaccine was available then get it since it will only be one dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,PVT,"Hydroxyzine, Zyrtec, Benadryl, Singular antihistamine","allergies all the time, limited diet","autoimmune disease, lesions in mouth tx with prednisone, asthma, nasal drip related to allergies.",When this PHN spoke to the client today asking if client had ever had an anaphylactic reaction she said y Additional information,"ct stated ""too many to list"", states she is allergic to alot o Additional information for Item 10: allergic to a lot of things, meds, food, takes alot of antihistamines i.e., hydroxine","['Discomfort', 'Pruritus']",1,MODERNA,IM 1047429,CA,40.0,F,"After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 days. She also experienced numbness of her left hip and swelling of her wrist. She was seen by her PCP and they did not associate the condition with the vaccine. After her 2nd dose on 1/28 she had a slight cough for 3 day and swelling of the arm and leg. She went to urgent care on 2/19 due to swelling and pain of her arms and legs. She was prescribed gabapentin, and pain medications. Employee developed left sided facial pain paralyses and went to the ED on 2/21 diagnosed with Bells Palsy and given acyclovir, norco and she is taking antibiotics for an ear infection. Currently still symptomatic.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/12/2021,1.0,OTH,unknown,unknown,unknown,,unknown,"['Cough', 'Ear infection', 'Facial pain', 'Facial paralysis', 'Headache', 'Hypoaesthesia oral', 'Joint swelling', 'Peripheral swelling', 'Sinus congestion']",1,PFIZER\BIONTECH,IM 1047430,CA,75.0,F,Woke up about 1:00 am in delirium and feverish. No control over thought process or able to get up. Managed to get out of bed at 9:00 am but was so weak could barely make it up a flight of stairs. And when I did ended up in bathroom vomiting. Laid on floor to get some strength back. Went back to bed and slept restlessly until 4:00 pm. Still feverish and weak but not as bad as earlier. Ate some cold grapes and went back to bed until the following morning. Tried to stay hydrated and took ibuprofen several times. My upper arm was red and blotchy for 3 days. Overall I?d say the severest part of the event lasted 48 hrs and another 24 hrs of tiredness and nausea but not vomiting.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PUB,,,,,,"['Asthenia', 'Delirium', 'Fatigue', 'Mental impairment', 'Mobility decreased', 'Nausea', 'Poor quality sleep', 'Pyrexia', 'Rash macular', 'Vomiting']",2,MODERNA,SYR 1047431,CO,17.0,F,Client was 17 years old at the time of administration.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PUB,None,None,None,,None,['Product administered to patient of inappropriate age'],2,MODERNA,IM 1047433,OH,68.0,F,"headache and stomachache for 3 days, passed out at 1:30 AM Feb. 11. Life squad called BP 90/60. Swelling of left upper arm, swollen lymph node under left arm that lasted 4 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/11/2021,1.0,PHM,"Chlorthalidone, Eperelone, Nifedipine, Lansoprazole, Dicyclormine HCL, Tizanidine HCL, Flurosemide, Tramadol, HydrOXYzine HCL, Venlafaxine, Budesonide, Bupropion, Tazarotene, Doxazosine, Carvedilol, Celecoxib, Citrucel, Caltrate+D, Vitamin",,"high blood pressure, asthma, back pain, arthritis",,,"['Abdominal pain upper', 'Headache', 'Loss of consciousness', 'Lymphadenopathy', 'Peripheral swelling']",1,MODERNA, 1047434,WA,88.0,M,"Patient died 3 days after receiving his first dose of the Covid vaccine. He saw his doctor 2 weeks prior to his death with absolutely no complaints, very healthy. He had no prior heart conditions and was pronounced dead of a heart attack.",Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/13/2021,3.0,UNK,none,Completely healthy check-up 2 weeks prior to vaccination and death.,none,,none,"['Death', 'Myocardial infarction']",1,PFIZER\BIONTECH,SYR 1047435,OR,41.0,F,deep vein thrombosis in lower left leg; mild fever; fatigue; body aches all in the day following injection DVT persists and was diagnosed 6 days later; all other symptoms resolved within 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/15/2021,1.0,OTH,combination birth control pills,none known,none,,none known,"['Deep vein thrombosis', 'Fibrin D dimer', 'Pain', 'Pyrexia', 'Ultrasound Doppler']",2,PFIZER\BIONTECH,IM 1047436,NY,70.0,F,"Onset of vaccine: 17:19 Onset of symptoms at 17:25 with tongue tingling to entire tongue Onset of other sx at 17:27: red hands Patient opted to stay in waiting room until hand concern She ambulated without assistance to medical center She was given Benadryl 25 mg po with water, tolerated well at 17:47 VS taken and stable 128/74 RR: 14 Pulse 82 At 18:00, sx of tongue tingling improved, but tinnitus BL worsened - this is common for patient She was discharged to home at 18:07 with her partner Instructed to call PCP in AM, and watch for other developing sx of allergy/anaphylaxis overnight",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,OTH,None,"Current dental oral infection on amoxicillin 500 mg TID, tetracycline oral swish BID x 10 days",,,IVP,"['Condition aggravated', 'Erythema', 'Paraesthesia oral', 'Tinnitus']",2,PFIZER\BIONTECH,IM 1047437,OH,42.0,F,"I experienced soreness in my arm the same day and night of the vaccine that continued for a few days. Then, a week and a day after receiving the vaccine, I developed ""Covid Arm"" with a red, itchy rash that was hot to the touch developing. The rash has faded significantly, but is still itchy and has last at least 9 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/04/2021,02/12/2021,8.0,SCH,"Blood pressure medications (Spironolactone, Amlodipine), birth control pills, Claritin D 12 hour.",,"Metabolic syndrome, psoriasis, high blood pressure",,Sulfa,"['Injection site reaction', 'Injection site warmth', 'Pain in extremity', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,SYR 1047438,,77.0,M,Autoimmune hemolytic anemia,Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/11/2021,02/18/2021,7.0,PVT,,,Chronic lymphocytic leukemia,,,['Autoimmune haemolytic anaemia'],UNK,PFIZER\BIONTECH, 1047439,PA,39.0,M,"Slurred speech, disorientation, uncoordinated movement, tingles at fingertips and toes",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,WRK,Fluoxetine 40mg/daily,None,depression (treated by physician with fluoxetine and therapy),,None,"['Disorientation', 'Dysarthria', 'Dyskinesia', 'Paraesthesia']",2,PFIZER\BIONTECH,SYR 1047440,CA,73.0,F,"Unsteadiness, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/14/2021,6.0,PVT,"Lisinopril Azathioprine Rosuvastatin Align Eyedrops: dorzolamide-timolol, restasis, travoprost",,Glaucoma RA,,,"['Balance disorder', 'Blood glucose', 'Dizziness', 'Electrocardiogram', 'Haemoglobin']",1,PFIZER\BIONTECH,SYR 1047441,NJ,60.0,M,"During our 3rd clinic, the facility registered this patient to receive their second dose of the Pfizer COVID-19 Vaccine, and they did not produce the record card. We administered the dose as requested. Upon returning to the Pharmacy to process the VAR, our records indicated that this patient had already received 2 doses of the vaccine at previous clinics.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,SEN,,"Epiliepsy, HIV","Epiliepsy, HIV",,"Flexeril, Cyclobenzaprine","['Extra dose administered', 'Inappropriate schedule of product administration']",3,PFIZER\BIONTECH,IM 1047442,WA,47.0,F,"Was fine immediately after, lips felt tingling several hours later and have not stopped tingling (48-hours later, sense of numbness and tingling in fingertips, increased awareness of sounds, brain fog, onset of pain at injection point later day of vaccine sore but manageable, excessive fatigue, deep muscle and joint aches, nerve sensations continuing.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,PHM,"Statin, COQ10, Multi-vitamin, vitamin D, Zinc, B-Complex, Probiotic",None,Celiac,,"Gluten, history of reactions to erythromycin, benzodiazapenes","['Arthralgia', 'Fatigue', 'Feeling abnormal', 'Hyperacusis', 'Hypoaesthesia', 'Injection site pain', 'Myalgia', 'Paraesthesia', 'Paraesthesia oral']",1,MODERNA,SYR 1047443,CT,59.0,F,"A large raised red rash that was painful, itchy and hot to the touch over the vaccination site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/06/2021,9.0,PVT,"Atenolol/Chlorthalidone, Singular, Symbicort, Multivitamin, Calcium and Vitamin D",None,"Hypertension, Asthma, Tinnitus and possible Long QT",,"Demerol, Latex, Avocado and walnuts","['Rash', 'Rash erythematous', 'Rash papular', 'Rash pruritic', 'Vaccination site reaction', 'Vaccination site warmth']",UNK,MODERNA,IM 1047444,AZ,34.0,F,"Vaccination was at 9:17am. Injection site arm pain and stiffness was noticeable by 12pm, and gradually worsened to incredibly painful by 8 pm, especially in muscles between left shoulder blade and spine. Chills began around 9:30pm at which point I took one 500mg Tylenol and went to sleep. I woke up with severe chills around 1:45 am and pushed off taking more 500mg Tylenol until 2:45 am. Afterwards I began to feel heartburn and slight nausea but was able to fall back to sleep. I woke up around 3:45 am to vomit. Afterwards, the nausea subsided and I was able to go back to sleep until 6:45am. I woke up with a headache which got worse and I took one Aleve at 9 am. By late afternoon I was feeling much better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,OTH,Tirosint Xyzal Birth control,Allergic rhinitis,Hashimotos thyroiditis,,Environmental allergies,"['Chills', 'Dyspepsia', 'Headache', 'Injection site pain', 'Injection site reaction', 'Musculoskeletal stiffness', 'Myalgia', 'Nausea', 'Spinal pain', 'Vomiting']",2,PFIZER\BIONTECH,IM 1047446,MN,70.0,F,"Excessive fatigue, nauseated, body aches, dizzy, and possible Covid Tongue? Although I asked my CNP today, and she did not feel I needed to worry about these blotchy, red areas on my tongue. The red color is lessening however.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,PVT,"Lisinopril, Atorvastatin, Metoprolol, Florastor, Candibactin AR, Candibactin BR, D Mannose, L-Glutamine, Betaine HCL, MultiVitamin, baby aspirin, Calcium+D3, Melatonin,",Nothing,"I am a DES Daughter. DES stands for Diethylstilbestrol, a man-made estrogen, which was a drug given to my Mother, while pregnant with me, to prevent miscarriage. It has had adverse effects for the Mothers who took the drug, the daughters and sons in utero as well as affecting the DES grandchildren (and who knows how many generations to come?).",,Wheat,"['Dizziness', 'Fatigue', 'Nausea', 'Pain', 'Tongue erythema']",1,MODERNA,SYR 1047447,MI,78.0,M,"Patient got 3 doses of Moderna vaccine by mistake. 1st dose on 01/06, 2nd dose on 01/26 and 3rd dose on 02/22",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,SEN,,,Multiple storkes,,,['Extra dose administered'],3,MODERNA,IM 1047448,KY,27.0,F,"Reported generalized pruritus, diffuse rash: face, neck, BUE, torso. Lethargic anxious HR 90, RR 20, Administer Epi injector right thigh. Given IM Benadryl. Transported to ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/20/2021,0.0,PUB,"Flonase, montelukast, Ivabradine",None,Pots,,"nuts, tree nuts, milk soy, amox","['Anxiety', 'Lethargy', 'Pruritus', 'Rash']",UNK,PFIZER\BIONTECH,IM 1047449,OK,58.0,F,soreness at injection site. then a mild migraine the following evening.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/23/2021,1.0,OTH,none,none,asthma and high blood pressure.,,"sulfur based drugs, shell fish","['Injection site pain', 'Migraine']",1,PFIZER\BIONTECH,IM 1047450,WY,76.0,F,"RN giving injection of Moderna vaccine to client noted vaccine leaking out at the hub, RN determined the leur lock connection between the needle and syringe was loose. Unknown amount of vaccine injected into the client, rest of vaccine in syringe discarded. New dose of vaccine with new needle/syringe injected into the client at that time. RN drawing up vaccine, and RN administering the vaccine need to double check the leurlock connection is tight prior to injecting the vaccine. Syringe/needle used-Smiths Medical jelco, Hypodermic NEEDLE-PRO EDGE, Safety Device with Syringe was used, most likely from lot #432510, 3 ml/LL 25G x 1in, that was provided in the ancillary kit that came with the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/03/2021,0.0,PUB,,,,,KNA,"['Device connection issue', 'Syringe issue']",1,MODERNA,IM 1047451,CA,70.0,M,Patient received 2 doses at the same day (dose #2 and #3 by mistake). No reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,SEN,Tamsulosin 0.4 mg 1 rab QD Metiprolo 50 mg 1/2 tab QD,Hypertension Prostate Enlargement,Hypertension Prostate Enlargement,,,['Extra dose administered'],3,PFIZER\BIONTECH,IM 1047452,AR,73.0,M,"patient describes total body aches/ pains, diarrhea, upset stomach, nausea the night/early morning the vaccine was given",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PHM,unknown,unknown,unknown,,unknown,"['Abdominal discomfort', 'Diarrhoea', 'Nausea', 'Pain']",UNK,MODERNA,IM 1047453,AZ,53.0,M,"53-year-old male who received the Covid 19 vaccination today and after 10 minutes developed dyspnea and pain in his left arm. He denies rash or swelling in his mouth, throat, lips. He has a history of asthma. No hypoxemia. Anxiety",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,PVT,not known,asthma,high blood pressure and diabetes,,not known,"['Anxiety', 'Dyspnoea', 'Electrocardiogram', 'Laboratory test', 'Pain in extremity']",1,MODERNA,IM 1047454,CA,17.0,M,"17 YO M, received Moderna Covid-19 vaccine (1st dose) on 01/19/21. Pt falls under the unauthorized age group for Moderna vaccine administration. On 02/22/21, pt returned to vaccination site for 2nd dose, 2nd dose was not administered d/t age requirements. Nurse Manager spoke to pt and father regarding deviation of vaccine administration. Pt nor father reported any adverse s/s after pt received 1st dose of Moderna on 01/19/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,PUB,Non stated.,Non stated,Non stated,,KNA,"['Incomplete course of vaccination', 'No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 1047455,MT,93.0,F,Resident deceased,Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/21/2021,2.0,SEN,"Amlodipine 10 mg qday, Iron Sulfate 325 mg bid, Lisinopril 20 mg bid, Metoprolol Tartrate 25 mg bid, Milk of Magnesia prn, Tylenol 650 mg prn, Senna Plus prn, Vitamin B 12 1000 mg qday, Vitamin D 50, 000 units qweek","Multiple falls, HTN, TIA, mild cognitive impairment, Gait abnormality, hearing loss, major depressive disorder, osteoporosis, central pontine myelinolysis","HTN, TIA, mild cognitive impairment, Gait abnormality, hearing loss, major depressive disorder, osteoporosis, central pontine myelinolysis",,NKDA,['Death'],1,PFIZER\BIONTECH,IM 1047456,FL,74.0,F,"2/16/21 - 7:30pm: Chills, fever, nausea, body pain and weakness, dizziness began. One episode of dry heaves; one episode of diarrhea. I could not eat, but could drink small sips of water. Symptoms continued until 5:00AM on 2/19/21. I was able to drink a cup of hot tea at approximately 9:00AM on the 19th. Body weakness and regular sensations of nausea continued until approximately 12PM on 2/20/21. Loss of appetite and sensation of familiar food tasting ""different."" As of 2/22/21 (6PM), I am continuing to feel overall weakness. Other symptoms have subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,PVT,Omeprazole; Levothyroxin; Clonidine; Atorvastatin,None,Acid reflux; moderate t high cholesterol,,Penicillin; pineapple,"['Asthenia', 'Chills', 'Decreased appetite', 'Diarrhoea', 'Feeding disorder', 'Nausea', 'Pain', 'Pyrexia', 'Retching', 'Taste disorder']",UNK,MODERNA,IM 1047457,ID,86.0,M,Diahhrea got very bad,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/18/2021,1.0,PVT,"Eliquis,","Prostate cancer, slow heart rate (possible pace maker in near future)","Diahhrea but nothing like this, controlled with pepto diahhrea pills",,None,"['Condition aggravated', 'Diarrhoea']",2,PFIZER\BIONTECH, 1047458,FL,79.0,M,"Currently waiting for dental work (crown removal and replacement to treat cavity). 2/18/21 Started to experience toothache (R) which got worse as the day progressed. Tylenol didn't help. Took one tab of Percocet (5-325) to allow me to sleep. 2/19/21 Contacted dentist and was prescribed Penicillin VK 500 mg. Started Penicillin around 3 pm. 2/19/21 ~6 pm onset shakes, chills, sweating, low grade fever (~100.2), nausea, headache, weakness, difficulty in standing. Took more tylenol, lay down, fell asleep for approximately 3 hours. Woke briefly took my nighttime meds (atrovastatin, metoprolol, ranolazine, baby aspirin.) Additional information for Item 18: 2/20/21 Felt better when I woke up. Temp normal. Ate breakfast. Mild stomach ache. Around 3 pm onset of sweating and chills, shakes. Low grade temp (~100) 2/22/21 Fully recovered. No lingering issues. Not sure whether what I experienced is related to the Moderna vaccine or a reaction to the Percocet I took to alleviate the severe pain associated with my toothache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/19/2021,2.0,PUB,"Clopidogrel,pantoprazole,atrovastatin,ranolazine,aspririn",,"CAD, hypercholesteremia",,NKA,"['Abdominal pain upper', 'Asthenia', 'Chills', 'Dysstasia', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pyrexia', 'Toothache', 'Tremor']",1,MODERNA,IM 1047459,TX,51.0,F,"Flu-like. Headache, sweats/chills, fever (100.1), tired, body aches - for 2 days Body aches/tired - continuing for 1 week Tired/low energy - for 2 weeks.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/02/2021,1.0,OTH,B12,None,None,,Penicillin,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Influenza like illness', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 1047460,FL,78.0,F,"Sore arm day of injection. No problem after. Eighth day following injection experienced redness, hard lump in arm 2-3 in diameter around site of injection, warm to touch and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/14/2021,02/22/2021,8.0,PHM,"premarin .625 mg, multi vitamin, D3",none,none,,slight allergy to shellfish,"['Injection site erythema', 'Injection site induration', 'Injection site mass', 'Injection site pruritus', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,IM 1047461,NJ,85.0,M,During our 3rd visit to the facility this patient was registered to receive their second dose of the Pfizer COVID-19 Vaccine. The Nurse did not produce the vaccination record card. We administered the dose as requested. Upon returning to the pharmacy to process the VAR our records indicated that the pt received 2 previous doses at previous clinics.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,SEN,,"Diabetes Type 2, HTN, TIA,","Diabetes Type 2, HTN, TIA,",,,"['Extra dose administered', 'Inappropriate schedule of product administration']",3,PFIZER\BIONTECH,IM 1047462,NV,80.0,F,"Pt develop redness around the injection site, about 1.5 inch in diameter. It is getting itchy the last couple day. Pt took benadryl to help with ichiness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,PHM,UNKNOW,NKDA,HYPERCHOLESTEROLEMIA,Pneumonia vaccine,NKDA,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 1047463,TX,61.0,F,"Pt with marked hoarseness, SOB, & Wheezing. O2 sat 89%, O2 applied. Benadryl 25mg given PO, Solumedrol 125mg given IM, Epi pen administered x2 doses. Transported via ambulance to hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,OTH,Unknown,Unknown,Unknown,,"Pneumonia Vaccine, Flu vaccine, PCN","['Dysphonia', 'Dyspnoea', 'Wheezing']",1,PFIZER\BIONTECH,IM 1047464,NY,19.0,F,"Swollen eyes, hives on face, neck wrists",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/21/2021,3.0,UNK,None,None,Healthy,,None know,"['Eye swelling', 'Urticaria']",UNK,MODERNA, 1047465,AZ,28.0,F,Fever of 103 for 2 days Could not lift left arm - significant pain and swelling Join aches Muscles aches Fatigue Loss of appetite Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,UNK,None,"Covid-19, January 01-14 Negative reaction to dose 1, January 21-24 (103 fever, body aches, significant pain and swelling in arm) Strep-throat like illness January 28-February 4th",None,Dose 1 of COVID_19 Moderna,None,"['Arthralgia', 'Decreased appetite', 'Fatigue', 'Headache', 'Injected limb mobility decreased', 'Myalgia', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,SYR 1047466,CT,68.0,F,Intense headache from temple across eyes to temple. Severe eye pain. Totally unlike my migraines. Lasted two days Also body aches. Lasted two days,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,UNK,"Nortriptyline, tylenol 3, Cingular, levocetirizine, anoro, lorazepam",Chronic migraine Seasonal allergies Arrythmia IBC,Arthritis Migraine Seasonal allergies,,Penicillin,"['Eye pain', 'Headache', 'Pain']",1,PFIZER\BIONTECH,IM 1047467,NJ,37.0,F,"Large red rash on the left arm that is warm To the touch. Low grade fever, headache and all over body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,PHM,Multivitamin and probiotic.,,,,,"['Headache', 'Pain', 'Pyrexia', 'Rash', 'Rash erythematous', 'Skin warm']",2,MODERNA,SYR 1047468,MD,33.0,F,"Started with raised red rash circling the injection site, and has been getting bigger everyday. Pain and itchy in rash area, pain deep inside my armpit, (maybe swollen lymph noid) frequent sweating under arms and hands",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/18/2021,9.0,PHM,Birth control (lo loestrin),,Herpes,,,"['Axillary pain', 'Hyperhidrosis', 'Injection site reaction', 'Rash', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",1,MODERNA, 1047469,NM,43.0,F,Patient passed through booster event of covid-19 Pfizer was told at check in she was not elidable for booster due to her first vaccine in series being Moderna. Since she was in same vehicle with her husband (who's first dose was Pfizer and there for booster dose) Misinformed vaccine staff she had moderna as primary dose and received Pfizer as second shot in her Covid series. Patient had no adverse reaction during her 30 minute observation period. Dr notified.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,unknown,unknown,unknown,,none,"['Interchange of vaccine products', 'No adverse event']",UNK,PFIZER\BIONTECH,IM 1047470,AR,52.0,F,"Itching, swelling at injection site, pain, heart palpitations, lymph node swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,PHM,Patient was taking allergy shots,,,"COVID19 Pfizer first dose - swollen lymph nodes, difficulty swallowing, dehydration",,"['Injection site pruritus', 'Injection site swelling', 'Lymphadenopathy', 'Palpitations']",UNK,PFIZER\BIONTECH,IM 1047471,NJ,84.0,M,During our 3rd visit to the facility this patient was registered to receive their second dose of the Pfizer COVID-19 Vaccine. The Nurse did not produce the vaccination record card. We administered the dose as requested. Upon returning to the pharmacy to process the VAR our records indicated that the pt received 2 previous doses at previous clinics.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,SEN,,,"iron deficiency, SOB, HTN",,NKA,"['Extra dose administered', 'Inappropriate schedule of product administration']",3,PFIZER\BIONTECH,IM 1047472,CA,45.0,M,"large mass under the armpit. possible swollen lymph nodes. muscle pain, fatigue, tingling feeling on the lower lip left hand side,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,02/19/2021,32.0,PUB,None,None,Polio,,None,"['Axillary mass', 'Fatigue', 'Myalgia', 'Paraesthesia oral']",2,PFIZER\BIONTECH,SYR 1047473,WV,63.0,F,"Chills 2 Days of Fever over 102.5 1 Day of Fever over 100 3 Days fever above normal Itchy Arm (after around 5 days) Severe headache and body aches for around 3-4 days Stomach issues - could not eat for 2 days - made me sick Very weak for about 3 days Took a week to feel almost normal, but still not 100% Arm still hurts Chest pain (note - had 3 stents put in on Dec 11 due to cardiovascular blockage). Had a shooting pain the first night. Not sure if related to the vaccination or not.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,SCH,Brilinta aspirin - low dose atorvastatin - lipitor lininopril. - prinival,no,"cardio-vascular disease - blocked arteries (had operation Dec 11, 2020)","A week after the first Moderna dose had some side effects - fever, chills, aches, stomach issues, etc. Only for a few days and n",none,"['Abdominal discomfort', 'Asthenia', 'Chest pain', 'Chills', 'Feeding disorder', 'Feeling abnormal', 'Headache', 'Malaise', 'Pain', 'Pain in extremity', 'Pruritus', 'Pyrexia']",2,MODERNA,SYR 1047474,AZ,65.0,F,"Intermittent severe pain in lumbar spine and hip joints. I tried heat, ice, and OTC NSAIDs with no improvement. Hydrocodone (left over from knee surgery in 2018) relieves pain for 3-4 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/21/2021,2.0,PHM,"Losartan, furosemide, citalopram, bupropion, levothyroxin, potassium chloride, fish oil, multivitamin",None,"High blood pressure, bradycardia, obesity",,None,"['Arthralgia', 'Spinal pain']",UNK,MODERNA,IM 1047475,MN,69.0,M,"Started having unilateral facial paralysis on 2/15/21, Presented in clinic on 2/17/21 with: R sided facial paralysis with smiling, frowning, raising eyebrows. No other systemic symptoms: no rash, no right sided body weakness - diagnosed with Bells Palsy and sent home with steroids and valacyclovir.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/15/2021,18.0,PUB,"Hydrochlorothiazide 25mg QD, Paxil 20mg QD, Amlodipine 10mg QD, Atenolol 100mg",None,Hypertension,,"Atorvastatin, pravastatin, lisinopril, losartan",['Facial paralysis'],1,MODERNA,IM 1047476,NE,75.0,M,"24 hours: Severe chill, low grade temperature (99.5 deg. F.) generalized acts and pains, one episode nausea with vomiting, fatigue. Rx: rest, fluids",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PHM,Pantoprazole Sod. 40mg tabs. 1 qd. Losartan 50mg 1 qd. ASA tabs 81mg 1 q other day. Amlodipine Besylate 5 mg. 1 tab. qd. Atorvastatin (generic Lipitor) 1 tab daily Bimatoprost (Lumigan) Opth. Sol. 1 gtt. OL/OD daily (PM),None,Hypertension,"Shingrix 1st dose , age 74 2018",None,"['Chills', 'Fatigue', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",UNK,MODERNA,IM 1047477,CO,17.0,F,Client was 17 yrs old at time of administration.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PUB,none,none,none,,none,['Product administered to patient of inappropriate age'],2,MODERNA,IM 1047478,AZ,66.0,F,"Rash started 2 days after, continued to spread daily through sunday on bilateral arms, hips, thighs, ankles lower legs Itchy, sent pics to portal endocrinologist and office visit to dermatologiston monday . after trying benedryl and hydrocortisone cream derm ordered steroid prescription cream and endocrinologist ordered oral steroid pac, will wait till friday before start oral to see if gets better",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/18/2021,2.0,PVT,"Vit d, calcium, prolia, brio, biotin estrace cream",None,Asthma osteopenia,,None,"['Pruritus', 'Rash']",2,PFIZER\BIONTECH,SYR 1047479,DE,60.0,F,"30 min after the injection I developed arm pain and a headache. Over the next 36 hours I developed a migraine, extreme body aches and severe arm pain. This was distinctly different arm and body pain compared to the first dose. I now understand the intractable headache after the first dose was a migraine. It was a horrible experience!!!!!!!. I laid down with ice on my body and finally took Tylenol after 24 hours. I was not able to get out of bed without pain; my life ceased for the duration. It was as it an alarm was set because ~ 6:00 a.m. Monday the 15th I woke up afraid to move only to learn that my body has reset and the pain was gone. I had returned to myself with only residual right arm pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/13/2021,0.0,PHM,,Adverse reaction to 1st does of Covid-19 vaccine,none,,"Latex & latex based foods Environmental allergies dust, dust mites, feathers, birch bark","['Headache', 'Migraine', 'Pain', 'Pain in extremity']",2,MODERNA,IM 1047480,CA,70.0,F,"Patient developed L sided facial tingling and left sided Headache about 6 hours after injection. No facial droop noted, neuro exam by MD was normal. Patient was given Benadryl 25mg PO x one dose, and improved within 30 mins. Discharged home in NAD",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,OTH,"Synthroid, welbutrin, Butalbital-Acetominophen-caff","Fibromyalgia, Migraines, hypothyroidism",as above,,"Avelox, lyrica, nortriptyline , sumatriptan, topamax","['Headache', 'Neurological examination normal', 'Paraesthesia']",2,MODERNA,IM 1047481,OH,67.0,F,"Moderna COVID?19 Vaccine EUA no immediate impact; severe joint pain began ~ 8 hours after injection; rash on back of right leg a few hours later; rash expanded to left leg and chest, and inside of both elbows; slight temperature for a few hours, but gone now. still have the rash and it is expanding. Saw a dermatologist, who said it is a typical ""viral allergic rash."" Told me he could not give me steroids, but gave me sample of cream to reduce itch and recommended OTC antihistamine seasonal allergy pills. He said I should not take the 2nd dose, but to follow the advice of Moderna and CDC re: that decision.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,OTH,"alendronate 70 mg tablet; atorvastatin 20 mg tablet; PARoxetine 20 mg tablet (off label use for neck arthritis and pain); levothyroxine 50 mcg tablet; lansoprazole 30 mg capsule; Calcium with vit. d ; Vit b6 qd ; D3-2000 50 mcg (2,000 unit",none,none,,codeine derivatives; Mepergan; methadone related drugs; Morphine; Naloxone; fentanol; Celecoxib,"['Arthralgia', 'Dermatitis allergic', 'Dermatologic examination abnormal', 'Pruritus', 'Pyrexia', 'Rash']",1,MODERNA,IM 1047482,NY,68.0,F,"Next day after vaccine: headache, some chills, some fatigue. Second day after vaccine: extreme fatigue until mid-afternoon.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache']",2,MODERNA, 1047483,CA,82.0,F,"Pain, redness, itchiness all over upper right arm near injection site. Started 6 days after vaccination and has lasted 6 days so far. Most severe on days 6-10 after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/17/2021,6.0,PVT,None,None,None,,None,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,IM 1047484,NJ,62.0,M,During our 3rd visit to the facility this patient was registered to receive their second dose of the Pfizer COVID-19 Vaccine. The Nurse did not produce the vaccination record card. We administered the dose as requested. Upon returning to the pharmacy to process the VAR our records indicated that the pt received 2 previous doses at previous clinics.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,SEN,,,Alcohol abuse,,Buproprion,['Extra dose administered'],3,PFIZER\BIONTECH,IM 1047485,DC,67.0,F,Fever of 100.3 degrees onset 24 hours after injection. Temperature returned to normal by 42 hours after injection. Soreness in arm where vaccine was administered.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PHM,Vitamin D,,Asthma,Slight arm soreness several times after flu vaccines.,,"['Injection site pain', 'Pyrexia']",2,MODERNA,SYR 1047486,NY,42.0,F,"Since the night of my shot, I have had the chills, fever, muscle and bodyaches, I can?t move my left arm where I got the shot, and it hurts to walk. I can?t keep food down and I am incredibly thirsty",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,SCH,Venavlacene,None,Colitis,,Penicillin,"['Chills', 'Injected limb mobility decreased', 'Myalgia', 'Pain', 'Pyrexia', 'Thirst']",2,MODERNA,SYR 1047487,NJ,41.0,F,Large red lump around site and itching comes and goes,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/15/2021,1.0,PHM,None,None,None,,Peniclin,"['Injection site erythema', 'Injection site mass', 'Injection site pruritus']",1,MODERNA,SYR 1047488,MI,26.0,F,"COVID vaccine at approximately 0815 on 2/19/21. Thirty minutes after receiving the vaccine patient started experiencing nausea and dizziness. A few minutes after the nausea began she had one episode of vomiting. She was asked to sit at the Nurse's station and elevate her feet. Her BP was 123/79, HR 88. Patient was advised that she needs to go to the ED. At first she did not want to go to the ED. She was convinced of the need to go and one of the Ophthalmology staff members took her to the ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,,,,,Clindamycin Penicillin,"['Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 1047489,TX,91.0,F,She had the vaccine on Thursday and no visible side effects. On Saturday she was very weak and had to be lowered to the ground. She was drooling and staring vacantly and was not responding to questions. This lasted for a bit. I called the ambulance which took her to the hospital. They hydrated her and sent her home with no idea what caused it. The next day she was sitting on the toilet and passed out with her eyes closed. She started drooling. I again called the EMTs and they came. She had come to and they said she fainted and it was probably because she was having a bowel movement. This has not happened before or since these two episodes. I do not know if she should get the next shot.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/06/2021,2.0,PVT,"Acidophilus, Aspirin, Biotin, Exemestane, Levothyroxine, Protonix DR, Glucosamine Chondroitin, Memantine, Tylenol, Amiodarone, Calcium citrate, Ocuvite, Vitamin K2 + D",UTI,"Congestive Heart Failure, Kidney Disease, Breast Cancer, Osteoporisis, Dementia, Hypothyroidism, GERD, Arrythmia",,,"['Asthenia', 'Drooling', 'Loss of consciousness', 'Staring', 'Syncope', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,SYR 1047490,CA,36.0,F,"Starting the night of vaccine - had a headache about 8PM in evening .I woke up feeling weird throughout the morning: fatigue - didn't want to move at all but not moving wasn't comfortable; fever, chills, joint and muscle aches - mostly in my back (I couldn't get comfortable) - felt like I had been hit by semi truck. Very weak - if that was a 10th of what COVID felt like, I didn't want it! Those symptoms lasted about three to five days. By the5th day - I was mostly back to myself. I took Motrin - which helped slightly for headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,MIL,Adderall,no,no,passed out - during bootcamp - with Vaccine - might have been the Yellow Fever one that caused it but not sure as I received mul,Ceclor,"['Arthralgia', 'Asthenia', 'Back pain', 'Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1047491,CO,73.0,F,"12 hrs after vaccination, sudden onset of violent vomiting , fever and diarrhea,.weakness.. was barely aware of self all night. at 9Am these Sx stopped and I noticed: swelling/redness at injection site 5"" diameter, burning skin left trapezius and below, on back of shoulder and down arm to wrist, walnut sized lump on left upper rib (5"" down from ""adams apple"" 2"" from center) similar on right side not as sore or big. In bed all day Sat and Sun with slight nausea, weakness, fatigue, joint pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/18/2021,17.0,PUB,Prednisone 7mg/day Oxicodone 45mg/24 hr period daily,,"OA, RA, Fibromyalgia, Sjrogens, Small Fiber Neuropathy, Meningioma, Lyden Factor 5 Heterozygous",one yr ago had Fluzone heavy dose and had same reaction...but slightly less severe and fewer Sx. Had not had flu vaccine for d,Allergic to shrimp cannot take NSAIDS due to Kidney issues,"['Arthralgia', 'Asthenia', 'Chest wall mass', 'Depersonalisation/derealisation disorder', 'Diarrhoea', 'Fatigue', 'Injection site erythema', 'Injection site swelling', 'Myalgia', 'Nausea', 'Pyrexia', 'Skin burning sensation', 'Vomiting']",2,MODERNA,IM 1047492,NC,17.0,F,"First shot of Moderna given accidentally on 1/23/21, without realizing patient was under 18; therefore, second shot was need on 2/20/21. Corporate and Moderna approved patient getting second shot on 2/20/21. Consent form was signed by gaurdian and authorized by pharmacy corporate and Moderna, since patient had already recieved first dose. No known adverse effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,SEN,,,,,,"['No adverse event', 'Product administered to patient of inappropriate age']",2,MODERNA,ID 1047493,MN,45.0,F,"After 8 days of getting the vaccine, I experienced redness and a hard bump on the vaccine area. It itches and it's hot. I went to the doctor and they prescribed Triamcinolone Acetonide Cream USP, 0,1% and zyrtec, plus cold compresses.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/21/2021,8.0,OTH,none,none,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Vaccination site induration', 'Vaccination site swelling', 'Vaccination site warmth']",UNK,MODERNA, 1047494,FL,87.0,F,Itchy rash at site of injection. Going away after 3 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/19/2021,7.0,PHM,,,,,,"['Injection site reaction', 'Rash pruritic']",1,MODERNA,IM 1047495,TX,71.0,F,"RAISED RED ITCHY AND SCRATCHY, WELTS APPEARED AT INJECTION SITE 8 DAYS AFTER RECEIVING IMMUNIZATION",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/21/2021,9.0,PHM,"FLUTICASONE NASAL SPRAY, METOPROLOL SUCC ER 50MG, OMEPRAZOLE DR 40MG, SIMVISTATIN 40MG",,,,NKDA,"['Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling', 'Urticaria']",1,MODERNA,IM 1047496,KY,62.0,F,RECEIVED 1ST DOSE OF PFIZER COVID 19 VACCINE ON 02/13/21. ON 02/22/21 WENT TO PROVIDER WITH COMPLAINT OF SEVERE HEADACHE AND WAS INSTRUCTED TO GO TO ER. ON 02/22/21 WENT TO ER WITH COMPLAINT OF SEVERE HEADACHE. DISCHARGE TO HOME SELF CARE IN REGARD TO FOLLOW UP WITH PCP FOR FURTHER EVALUATION SINCE DID NOT AGREE TO CT SCAN.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/22/2021,9.0,PVT,,,,,SIMVASTATIN LYRICA WASP VENOM SAXENDA AMLODIPINE,"['Headache', 'Refusal of treatment by patient']",UNK,PFIZER\BIONTECH,IM 1047497,AR,76.0,M,ADMINISTRATION OF EXTRA DOSE BY NURSING HOME STAFF,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,SEN,,,,,,['Extra dose administered'],3,MODERNA,IM 1047498,,30.0,M,"Fever, chills, dizziness, weakness, fatigue. Onset roughly 6hrs after 2nd dose of vaccine. Duration: 30 hours. 2 weeks after 2nd dose of vaccine- full body hives, itching, constricted airway following exposure to cat. This was an unprecedented reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,02/12/2021,15.0,UNK,"Vitamin D 5,000 iu qd N.A.C.- 1,000 mg qd",,,,wheat and dairy sensitivities,"['Allergy to animal', 'Asthenia', 'Chills', 'Dizziness', 'Fatigue', 'Obstructive airways disorder', 'Pruritus', 'Pyrexia', 'Urticaria']",UNK,MODERNA,IM 1047499,PR,78.0,F,"Fever, pain on injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/24/2021,01/24/2021,0.0,PHM,,,"Hypothyroidism, HBP, high cholesterol, glaucoma, alzheimer",,"Sulfa, vancomycin, parafonforte","['Injection site pain', 'Pyrexia']",1,MODERNA,IM 1047500,IN,66.0,F,"Redness at injection site, itching at injection site, injection site is warm to the touch",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/22/2021,11.0,PHM,None,None,Diverticulosis,,Cefdinir Sulfa drugs,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",UNK,MODERNA, 1047501,AR,89.0,F,ADMINISTRATION OF EXTRA DOSE BY NURSING HOME STAFF,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,SEN,,,,,,['Extra dose administered'],3,MODERNA,IM 1047502,OR,29.0,F,Chest pain within 5 minutes and heart palpitations every 5 minutes for 30 minutes. After 30 minutes they were their worst and blood pressure was checked to be 140/90. Heart palpitations and chest pain have not subsided for patient.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/07/2021,0.0,OTH,None,Radial Fracture Right arm,None,,None,"['Chest pain', 'Palpitations']",1,PFIZER\BIONTECH,IM 1047503,CA,83.0,M,"Patient?s first dose of the COVID vaccine was Moderna but on the second dose, he was accidentally given the Pfizer vaccine. The nurse realized she had given the wrong one when she went to fill out his card.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/21/2021,02/21/2021,0.0,PVT,"Atorvastatin, Advil, baby aspirin, vitamin D",None,"Arthritis, high cholesterol",,None,['Interchange of vaccine products'],2,PFIZER\BIONTECH,IM 1047505,CA,34.0,F,"Developed swelling to face, gums, throat-unable to swallow. Denies SOB. Went to urgent care treated to Solumendrol and Solumedrol dose pack. Resolved after 3-4 weeks. Now at baseline.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/21/2021,1.0,PVT,None.,None,None,,"Acetaminophen, NSAIDS","['Dysphagia', 'Gingival swelling', 'Pharyngeal swelling', 'Swelling face']",2,PFIZER\BIONTECH,IM 1047507,AR,81.0,F,ADMINISTRATION OF EXTRA DOSE BY NURSING HOME STAFF,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,SEN,,,,,,['Extra dose administered'],3,MODERNA,IM 1047508,WA,39.0,F,Arm was red and slightly swollen. The red area itched. The redness appeared where the vaccine was injected. It was about 2 inches by 6 inches down my arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/17/2021,01/24/2021,7.0,PVT,Daily vitamin,None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 1047509,WA,65.0,M,"Sudden onset fever, headache, exhaustion Duration < 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PVT,"Supplements: Vitamin C, Folic Acid, D3, Fish oil, Cal/Mag/Zinc, ASA 81mg, Vitamin 3 Dupixent, Combivent Respimat, Serevent Diskus, Montelukast, Alvesco, Furosemide, Testosterone, Bystolic, Adderall, Lamotrigine, Potassium, Trimix",none,Moderate to severe asthma Moderate obesity Hypertension Depression Complex PTSD ADD Hypogonadism,Shingles - Fall 2020,NKDA,"['Fatigue', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1047510,AZ,30.0,M,"Received on 12/23/2020 Dose 1 MODERNA 011J20A; Dose 2 on 1/20/2021 042L20A On 2/19/2021, patient underwent asymptomatic pre-travel testing that returned positive PCR for COVID-19 He was asymptomatic. He has no known prior history of COVID-19",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,02/19/2021,30.0,MIL,none,,none,,"amoxicillin, septra - rash","['Asymptomatic COVID-19', 'SARS-CoV-2 test positive']",2,MODERNA,IM 1047511,WA,62.0,F,"I developed chills/shivering in the evening of the vaccination (2/19/21) but was not alarmed, just tried to stay warm. I ate normally. I awakened in the night with extreme chills and was shaking most of the night, unable to get warm. I felt feverish and had body aches as well as nausea. I threw up what I could to alleviate the feeling of nausea, about 2 a.m. I slept restlessly until 9:00 am, then tried to take a hot shower. Though the chills were gone, I felt weak and listless and went back to bed shortly after showering. I slept for about 4 hours. I had little/no appetite for most of the day after the vaccine. By the second day I still had a headache but felt better, albeit weak. I took Ibuprofen for the body/headaches with minimal success.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PUB,levoxyl - generic,No,No,,No,"['Asthenia', 'Chills', 'Decreased appetite', 'Feeling cold', 'Headache', 'Listless', 'Nausea', 'Pain', 'Poor quality sleep', 'Pyrexia', 'Vomiting']",2,MODERNA,SYR 1047512,KS,,U,Patient had a delayed swelling and expanding rash at injection site -- 8 days after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,PHM,,,,,,"['Injection site rash', 'Injection site swelling']",1,MODERNA,IM 1047513,MO,36.0,M,EXPERIENCED NUMBING AT THE BASE OF THE TONGUE THE EVENING OF 2/13/21. EXPERIENCED TINGLING AT THE NAPE OF THE HEAD 2/14/21. PT WAS NOT ABLE TO CLOSE LEFT EYE COMPLETELY THE MORNING OF 2/15/21.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/13/2021,02/13/2021,0.0,PHM,NONE.,NONE.,NONE.,,"NO KNOWN ALLERGIES TO MEDICATION, FOOD, OR OTHER PRODUCTS.","['Eye movement disorder', 'Hypoaesthesia oral', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 1047514,IL,60.0,M,"muscle/body ache, bad headache, pain, redness, and swelling at injection site approximately the size of a grapefruit, nauseated, neck swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,PVT,"Eliquis, Fish Oil, Lisinoprol, Metformin, Zetia, Xyzal, Multi-vitamin, Preservision, Praluent.",none,"high blood pressure, high cholesterol, stroke, hayfever",,"Codeine, Penicillin, Leviquin, ekg lead adhesive","['Headache', 'Injection site erythema', 'Injection site swelling', 'Myalgia', 'Nausea', 'Pain', 'Swelling']",2,MODERNA,IM 1047515,NY,50.0,F,"body aches, fever, chills, head ache, arm soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/22/2021,14.0,PVT,generic adderall 50mg generic Wellbutrin 150mg,none,,,none,"['Chills', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 1047516,OK,77.0,F,"2/15 (day 4 following injection) dev rash on chest, no itch. Twelve hours later developed rash on both forearms which was itchy. Then rash dev on her back and abdomen, and dev severe itch in vaginal and rectal area. Eval in Minor Emergency center 2/19. Prescribed Prednisone orally, which she has not started, and also Triamcinolone cream which she is applying as needed. 2/21 developed rash on back of upper thighs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/15/2021,4.0,PHM,Bisoprolol 25 mg daily,no,Hypertension,,"Codeine - rash, nausea","['Anal pruritus', 'Rash', 'Rash pruritic', 'Vulvovaginal pruritus']",1,MODERNA,IM 1047517,PR,78.0,F,"Fever, pain on injection site, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,PHM,,,"Hypothyroidism, HBP, high cholesterol, glaucoma, alzheimer",,"Sulfa, vancomycin, parafonforte","['Headache', 'Injection site pain', 'Pyrexia']",2,MODERNA,IM 1047518,CA,60.0,F,"""Covid Arm"": Day 10 after 1st dose - Huge triangle shaped rash on injection site ca 4w"" x 6h"", warm to touch, itchy; no hardness no welts. Lasted ca 4-5 days. Slight fever 99.0 fahrenheit (my usual average 97.9-98.0), very slight headache both lasting ca 1.0-1.5 hours when rash appeared after showering. Since then have received 2nd dose (Moderna #006M20A) same arm as 1st dose; day 7 and no side affects. I have also reported this on V-Safe App. (Have picture to share if needed.)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/28/2021,10.0,UNK,"St. John's Wort (1 capsul, 300 mg 0.3% Hypericin + 150mg Hypericum perforatum flowering herb, Sprouts Brand) daily. Enjoy wine.",None,"None (""healthy as an ox"")",,Possibly Penicillin (overall slight rash as teenager).,"['Headache', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth', 'Pyrexia']",1,MODERNA,SYR 1047519,NY,33.0,M,"About five to six days after the vaccine, extremely itchy hives broke out across various parts of my body, after having no side effects (not even a sore arm) following the vaccine. It went away with no treatment in about 48 hours. I know that is not one of the common side effects and it occurred long after the shot, so I wanted to report it in case anyone else does as well. Of course, it may have been caused by something else, but I have never in my life had anything similar occur; nor had taken any new medications or eaten new foods.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/19/2021,6.0,OTH,Doxycycline 40 mg Solantra Financea Rhofade NatureMade Multivitamins NatureMade Vitamin C,None,Rosacea,,Pollen Some fruits,"['Pruritus', 'Urticaria']",2,MODERNA,SYR 1047520,OH,55.0,F,"2) ""Stoned"" From 8:15pm 2/5 thru 12:00 pm 2/7 1) Sporadic vibration of entire body 3) Constipation",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,SCH,"Tomoxifen, D3, multi vitamin",none,mitro valve prolapse,,"Ultram, Zofran, Letrozole, Anastrozole","['Constipation', 'Feeling abnormal', 'Tremor']",1,PFIZER\BIONTECH,IM 1047521,MN,43.0,F,"Red swollen area at the site of injection, approx 3 inches by 5 inches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/19/2021,6.0,UNK,"Sertraline, Wellbutrin",None,None,,NKA,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 1047522,CA,51.0,F,"Both arms began feeling heavy, weak, clumsy 2 days after my 1st dose. Kept up and got more pronounced throughout week and started feeling burning sensations in both arms through Feb 15th. Self referred to Neurology on Feb. 16th. Feb 17th, began to feel worse, spreading to both legs feeling weak, burning sensation, fatigue, and began feeling VERY foggy brained. Have been sleeping a lot, but legs and arms go from burning sensations, weakness, to cold sensations, and achy right leg thigh muscle, to this moment. Brain fog and fatigue seem worst in morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/08/2021,2.0,PUB,none,none,none,,none,"['Blood test normal', 'Burning sensation', 'Clumsiness', 'Fatigue', 'Feeling abnormal', 'Feeling cold', 'Hypersomnia', 'Limb discomfort', 'Muscular weakness', 'Myalgia']",1,MODERNA,IM 1047523,OH,26.0,F,Pt states she developed muscle aches about 12 hours after receiving the vaccine and the muscle aches continued for 24 hours. She states the muscle aches has resolved now.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,OTH,,,,,,['Myalgia'],UNK,PFIZER\BIONTECH,IM 1047524,NM,28.0,F,"1 week post-vaccine, my deltoid (injection site) became swollen, severely erythematous and very itchy with a single wheel/welt over the injection site. Lasted approximately 36-48 hours, then swelling, erythema, and itchiness began dissipating .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/10/2021,7.0,PHM,Ocella (drospirenone 3mg/ethinyl estradiol 0.03mg),None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria']",1,MODERNA,IM 1047525,TX,37.0,F,"Started with sinus congestion on the 2nd. Then a bad headache - on the 3rd. Both continued and on the 4th I went to the Care Now Urgent Care COVID test. No treatment except ibuprofen; Claritin; Tylenol - those helped some. I had the headache and sinus congestion until Wednesday - and then I felt pretty much back to normal except for some fatigue for next two days. I got the second dose of the vaccine - Monday, January 25th. I had a bad headache - and achy feeling - but after 24 hours I felt back to normal again.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/02/2021,5.0,PVT,Multi-Vitamin; Krill oil,no,no,,Sulpha; Penicillin,"['Fatigue', 'Headache', 'Pain', 'SARS-CoV-2 test positive', 'Sinus congestion']",1,MODERNA,IM 1047526,OR,85.0,F,"Patient reports lower lip feels tingly and puffy, denies other symptoms. Given Benadryl 25 mg PO per MD. Approx 20 min later reports feet feel tingly, provider ordered another dose of Benadryl 25 mg PO. Symptoms subsided and MD cleared for discharge. Friend will drive patient home.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,PUB,,,,,,"['Lip swelling', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 1047527,CA,63.0,F,"nausea, sharp abdominal pains, flushing, fever to 100.9 degrees F beginning the morning after second immunization (approx. 18 hours post) and lasting approx. 12 hours, some residual abdominal pain and nausea for an additional day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,OTH,"thyroxine, bioidentical progesterone/estradiol, baby aspirin, Vit. D, multivitamin",none,mild psoriatic arthritis,,?bergamot?,"['Abdominal pain', 'Flushing', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1047528,MN,42.0,F,"One week to the day of receiving my first dose of the Moderna COVID-19 vaccine, the injection site began to itch and a hard ?knot? developed. I thought the ?knot? was in my muscle, but maybe not. Upon visual inspection, a red area developed around the injection site, about the size of a 50-cent coin. The red area was slightly painful when touched. Now, 2 days later, the red area is still visible and the area still itches, but much reduced in intensity.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,UNK,Apri - oral contraceptive Flinstone multi-vitamin Gaia Black Elderberry syrup,None,None,"Similar to an allergic reaction (itching, racing heart, bloodshot eyes, difficulty breathing) after receiving a flu vaccine afte",Sulfur drugs,"['Injection site erythema', 'Injection site induration', 'Injection site nodule', 'Injection site pain', 'Injection site pruritus']",1,MODERNA, 1047529,NC,81.0,F,"Patient became flush and light headed after her 2nd shot of Pfizer. Patients BP was 140/78 and continued to rise to 170/80, pulse dropped from 78 to 62, patient developed facial redness and after 90 minutes of observation she became to feel a lump in her throat. No difficulty breathing or respiratory issues.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PVT,"acetaminophen (TYLENOL) 500 MG tablet amLODIPine besylate (NORVASC) 5 mg tablet aspirin (ASPRI-LOW,ECOTRIN LOW DOSE) 81 mg EC tablet atorvastatin (LIPITOR) 40 mg tablet FERROUS SULFATE 325 (65 FE) MG EC tablet glucose blood (ONETOUCH ULTRA",,Depression Hypertension Esophageal reflux Cardiac pacemaker in situ Restless legs syndrome Familial multiple lipoprotein-type hyperlipidemia Postsurgical percutaneous transluminal coronary angioplasty status Iron deficiency anemia Type 2 diabetes mellitus without complications (*) Coronary artery disease involving native heart with unstable angina pectoris (*) Platelet inhibition due to Plavix Class 1 obesity with serious comorbidity and body mass index (BMI) of 33.0 to 33.9 in adult Pes anserinus bursitis of right knee Symptomatic anemia Fatigue Microcytic anemia �,,"Bactrim [Sulfamethoxazole W/trimethoprim]Itching LatexItching AmoxicillinRash, Hives CiprofloxacinRash MetronidazoleUnknown CodeineNausea Only ProtonixRash Tetracyclines & RelatedDiarrhea","['Blood pressure increased', 'Dizziness', 'Erythema', 'Flushing', 'Heart rate decreased', 'Sensation of foreign body']",2,PFIZER\BIONTECH,IM 1047530,CA,68.0,F,Patient reported lightheadedness within 30 mins after vaccination. Patient denied any other symptoms. Patient was also noted to be hypertensive (BP=160/100) upon taking vital signs.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PUB,,none,history of vasovagal episodes,lightheadedness,allergy to codeine,"['Dizziness', 'Hypertension']",2,PFIZER\BIONTECH,IM 1047531,CA,66.0,F,Within 45 minutes of receiving the the Moderna injection I started with a headache and the beginning of hives. I took a Benadryl to stop the hives progression. I had to take antihistimes for several days. The hives never popped up so the meds helped. My head felt bruised and heated as if the blood was pumping around my skull. The headaches are still intermittent 6 days later. I did not seek medical care.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/16/2021,0.0,PUB,Brimonidine Tartrate Ophthalmic Solution,None,"Asthma, pre diabetic",,"Food Allergies: strawberries, jackfruit, kiwi, dried apricots, shellfish Medications: Erythromycin, CT contrast dye, Sulphur on dried fruits","['Feeling hot', 'Head discomfort', 'Headache', 'Urticaria']",1,MODERNA,IM 1047532,WA,57.0,F,"There is no adverse event, but the patient received 2nd dose of Moderna vaccine on day 49 after 1st dose because she received the 1st dose at another site (healthcare clinic) and she had to travel out of state due to a family member's death.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/15/2021,02/15/2021,0.0,PVT,None,None,None,,"Latex, Tolmetin","['Inappropriate schedule of product administration', 'No adverse event']",2,MODERNA,IM 1047533,MI,65.0,M,"I am allergic to polyethylene glycol ? it actually put me in the hospital for years ago. I had no idea it was in the vaccine, although a smaller amount than I had taken before. I started experiencing severe and awful anxiety and panic that night I got the vaccine. I had other minor side effects that were expected but they went away within a day. Several days later, I began experiencing pain in both my bilateral Achilles tendons and bilateral knee pain. A physical therapist examined both and said that I was swollen. I have had both of those problems under control for a very long time. I am improving somewhat but nearly 2 weeks later I am still having some repercussions. I am now scared and don't know if I should get the second injection done because the previous adverse symptoms were awful. Thank you.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/11/2021,0.0,PHM,Synthroid Latanprost eyedrop the night before,Fluoroquinolone toxicity. Minor heart afib..,Fluoroquinolone toxicity. chronic pain.,,"fluoroquinolones, Flagyl,, Bactrim,, prednisone, MiraLax, numerous other medications but never a vaccine.","['Anxiety', 'Arthralgia', 'Joint swelling', 'Panic reaction', 'Peripheral swelling', 'Reaction to preservatives', 'Tendon pain']",1,MODERNA,IM 1047534,CO,58.0,F,"Shot was given Tues morning around 7:40 am. It was a bit sore, but nothing else that day. Wednesday morning woke up, arm very sore still. I had no energy, very lethargic. Got a fever by mid morning. Chills, hot and cold off an on all day. Not much of an appetite. Thursday I woke up feeling fine, however arm was still pretty sore. By late Thursday night I started seeing a red rash on my left arm (injection site) It continued to spread all over my body for the next few days. Legs are very itchy and red. Used an anti itch cream, took a Claritin antihistamine. No real pain, but uncomfortable with the itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/18/2021,2.0,PVT,Warfarin Sodium 5 MG Potassium chloride ER 10 MEQ hydroCHLOROthiazide 25 MG Multi vitamin Vit D Vit E Vit B complex fish oil glucosamine condrigton calcium magnesium leutein,,"Allergies - trees, dust, mold, mildew, smoke",,penecillin,"['Asthenia', 'Chills', 'Decreased appetite', 'Discomfort', 'Erythema', 'Feeling of body temperature change', 'Injection site pain', 'Injection site reaction', 'Lethargy', 'Pain in extremity', 'Pruritus', 'Pyrexia', 'Rash', 'Rash erythematous']",2,MODERNA,SYR 1047535,SC,33.0,M,"PATIENT WAS IN POST-VACCINE WAITING PERIOD IN A CHAIR NEAR PHARMACY TWO TO THREE MINUTES POST VACCINE AND HAD A SYNCOPAL EPISODE. PATIENT SLOWLY FELL OUT OF CHAIR ONTO THE FLOOR. PHARMACIST WAS NEAR AND WAS ABLE TO HOLD ONTO HIM AND LOWER HIM TO THE FLOOR ALONG WITH HIS MOTHER. WHILE 911 WAS CALLED PHARMACIST CHECKED BLOOD PRESSURE AND LOWERED HIM TO A YOGA MAT. BP WAS 95/63 WITH PULSE 49. PATIENT SWEATING PROFUSELY BUT DID REGAIN CONSCIOUSNESS QUICKLY. PATIENT WAS REMOVED FROM PHARMACY VIA PARAMEDICS ON A STRETCHER. VACCINE ADMINISTERED AT 6:16PM, EMS ARRIVED AT 6:27PM. PATIENT'S MOTHER RETURNED TO PHARMACY AROUND 6:45PM AND STATED THAT HE WAS RELEASED FROM AMBULANCE AND WAS GOING HOME WITH HER.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PHM,"LOSARTAN, GABAPENTIN, EFFEXOR,","HIGH BLOOD PRESSURE, ASTHMA, HISTORY OF SYNCOPE","HIGH BLOOD PRESSURE, ASTHMA",,NKDA,"['Condition aggravated', 'Fall', 'Hyperhidrosis', 'Loss of consciousness', 'Syncope']",1,MODERNA,IM 1047536,DE,31.0,F,"Received vaccine on 02/02, 4 weeks pregnant on 02/03 02/03-02/05: Severe lethargy, tiredness, pain at injection sites, fever all lasting 48 hours. Symptoms subsided after taking tylenol on 02/05. I'm not attributing this to the vaccine, but on 02/12, my hcg started to plateau and decline, no egg yolk or fetal pole was seen at 6 weeks (2/17). Sac was measuring at 5 weeks. I eventually had a miscarriage on 2/21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/03/2021,1.0,UNK,Tylenol on day 2 after vaccination,,,,,"['Abortion spontaneous', 'Exposure during pregnancy', 'Fatigue', 'Human chorionic gonadotropin decreased', 'Injection site pain', 'Lethargy', 'Pyrexia']",2,MODERNA,IM 1047537,WI,65.0,F,Nausea and vomiting; fatigue; headache; light sensitivity; muscle and joint pain; fever 99.1; chills; tenderness injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/10/2021,1.0,PVT,Fluticasone prop/salmeterol 250/50 inhaler; multivitamin/minerals;Esomeprazole 20mg; vitamin d 5000iu; vitamin B12 50mcg; Clobetasol prop 0.05% topical solution/ cetaphil cream,None,"Obesity, hyperlipidemia, GERD, vitamin d deficiency, prediabetes, diverticulosis",,Sensitivity to Cipro= hives and sore hip joints.,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Nausea', 'Photophobia', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 1047538,NY,68.0,F,"After receiving the shot at 9:00 a.m., at 6:00 p.m. I started to feel very tired and as if I was getting a fever. By 9:00 p.m. I was shaking from chills (despite being bundled up under a blanket), so I took my temperature -- it was 100.5 degrees orally. My normal temperature on that thermometer is 97.6 degrees. That night, I kept waking up every two hours or so and was very uncomfortable. THe next day I felt very lethargic -- unable to do anything other than make myself something to eat. I took two naps, one in the morning, and the other in the afternoon (that was about two hours). I felt slightly better by around 8 p.m. That night I slept somewhat better and felt myself break into a sweat during the night -- so I guess that is when the fever broke. The next day (today) my temperature was back to normal and I feel okay. Throughout the now three days, the arm where I got the shot was painful, but gets less so each day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,"Pepcid , 20 mg; Citracal; Vitamin B complex plus C",none,"lung cancer, COPD",,"sulfa, retin-A, several antibiotics","['Chills', 'Discomfort', 'Fatigue', 'Injection site pain', 'Lethargy', 'Night sweats', 'Pyrexia', 'Sleep disorder']",2,MODERNA,IM 1047540,NY,26.0,M,"Fever, sorness in the injection site, chills. Started to occurs between 4- 7 hours after the injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/22/2021,1.0,UNK,"Oxybutynin, iron, Prozac, Levaquin, Protonix, multivitamin.","Uti, bronchitis","Spina Bifida, asthma",,Latex and amoxicillin,"['Chills', 'Injection site pain', 'Pyrexia']",1,MODERNA,IM 1047541,MA,57.0,F,The injection area of the left arm with redness and swollen. It's the 8th day after receiving the vaccine. No treatment.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/15/2021,1.0,OTH,none,none,History of Grave's disease,,"Doxycycline, penicillin","['Injection site erythema', 'Injection site swelling']",UNK,MODERNA, 1047542,CO,48.0,F,"I had a sore arm and a raised bump for about 3 days, It went away. 10 days later it is back. Hard raised bump at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/22/2021,9.0,WRK,,na,,,"meloxicam, bactrim, cipro,","['Injection site induration', 'Injection site swelling', 'Pain in extremity']",UNK,PFIZER\BIONTECH,SYR 1047543,TX,25.0,F,"102 Fever, inactive high heart rate 144, loss of appetite, weight loss, Injection site pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,OTH,Levothyroxine,UTI,Hypothyroidism,,,"['Decreased appetite', 'Heart rate increased', 'Injection site pain', 'Pyrexia', 'Weight decreased']",1,MODERNA,SYR 1047544,CA,44.0,F,"Stye developed on 2/1/2021 to left eye, consulted PMD. NO tx resolved after 4 days later. Then 5 days later developed rash to bialteral arms and gluteal region, resolved at the end of day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,02/01/2021,2.0,PVT,None,None.,None,,NOne,"['Hordeolum', 'Rash']",2,PFIZER\BIONTECH,IM 1047545,IL,45.0,F,"Nausea, dizzy, hot flashes, chills, gastrointestinal upset",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/23/2021,8.0,PUB,,Mild gastrointestinal illness the weekend before,,,Gluten intolerance; penicillin allergy,"['Abdominal discomfort', 'Chills', 'Dizziness', 'Hot flush', 'Nausea']",2,MODERNA, 1047546,CA,73.0,F,"Chills,headache, dizziness and weakness, palpitations",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/10/2021,2.0,PUB,Blood pressure medicine,None,Allergies,,None,"['Asthenia', 'Chills', 'Dizziness', 'Headache', 'Palpitations']",2,MODERNA,SYR 1047547,NC,66.0,F,"Swelling, redness and itching in L arm 7 days after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/20/2021,19.0,UNK,Lisinopril 10 mg daily,None,Hypertension,,Codiene,"['Erythema', 'Peripheral swelling', 'Pruritus']",1,MODERNA,IM 1047548,VA,33.0,F,"Severe headaches exhaustion depression, crying spells, mental breakdown severe muscle spasms over the neck, upper, middle, and lower back Knee pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/06/2021,8.0,PVT,"Motrin, multivitamins, vitamin D, Biotin, Metaxalano (occasionally), Allegra",none,cervical issues,,none,"['Arthralgia', 'Crying', 'Depression', 'Emotional distress', 'Fatigue', 'Headache', 'Muscle spasms']",1,PFIZER\BIONTECH,IM 1047549,TX,78.0,F,"Facial flush, flare of eczema, burning",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/22/2021,2.0,PUB,"advair, albuterol, mukolast,",,"COPD, asthma",,,"['Burning sensation', 'Eczema', 'Flushing']",1,MODERNA,IM 1047550,OH,34.0,F,"Left-sided back pain started 2/6 and occurred intermittently. On 2/15, the back pain worsened and I developed gross hematuria, urinary urgency and frequency. On 2/17, I had a KUB series which showed a left distal ureteral stone. On 2/18, I passed a 3 mm kidney stone. I have no prior history of nephrolithiasis. There were no recent changes in diet or fluid intake.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,02/06/2021,9.0,UNK,"Metformin 500 mg BID, Zoloft 50 mg QD, vitamin D 2,000 IU daily","Anxiety, miscarriage 11/2020","Recurrent pregnancy loss, anxiety",,,"['Back pain', 'Calculus urinary', 'Haematuria', 'Micturition urgency', 'Pollakiuria', 'Ureterolithiasis', 'Urinary system x-ray abnormal']",2,MODERNA,IM 1047551,OR,45.0,F,"Elevated temperature, feeling as though I was outside of my body during fever (quasi-dissociative), sweating and heat episodes (heat feels like it's emanating from from my neck/shoulder area). Additional SE's: pain at injection site, fatigue. Quasi-dissociative feeling resolved after fever stopped. At this writing, still having sweating episodes, pain diminished considerably, fatigue waxing and waning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,OTH,Zyrtec Wellbutrin Trintellix Turmeric Vitamin D Trazadone,None,Depression Arthritis,,"Food- Agave, Stevia, Sumac","['Body temperature increased', 'Dissociative disorder', 'Fatigue', 'Feeling hot', 'Hyperhidrosis', 'Injection site pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 1047552,CA,67.0,M,"One week after 1st shot, woke up with Moderna ""Covid Arm"", large red circle at the injection site. It was itchy but not painful to the touch, treated it with topical spray. Today is 2nd day, ""rash"" grew from 2"" to 3"" around, still itchy but not painful. I was concerned until I read a helpful article at website which said to report it to you, assist you with research. The article says it goes away in 3-7 days, so I will mark ""No"" under ""is patient recovered"" below, as it has not yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PHM,"Fluvaststatin, Omeprazole, fish oil pills, 1-A-Day vitamin",none,none,,none,"['Injection site erythema', 'Injection site reaction', 'Rash pruritic']",1,MODERNA,SYR 1047553,WA,60.0,F,"Woke up during the night with chills that had my body shivering and a headache. Did not get up until morning because I didn't want to get out of the covers even though I was cold. Took some ibuprofen which helped with both the chills and headache. I had no energy and was very tired. I slept most of the day and woke up to go to the bathroom and take more ibuprofen. Towards the evening I could tell that I was feeling a bit better. I was able to take a bath, more ibuprofen and went to bed. Slept pretty well. Woke up once and took ibuprofen because of headache and body aches. Felt much better on Sunday. Was still tired and slept a good part of the day. My arm continues to ache, but is not really painful unless I try to lift it.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,WRK,None,None,None,,None,"['Asthenia', 'Chills', 'Fatigue', 'Feeling cold', 'Headache', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 1047554,NC,75.0,F,"at 11:30 PM noticed increasing labored breathing with wheezing ; felt like a band was across chest;. Sat up in chair, concentrated on NOT gasping , as exhale was most difficult. Started to ease up around 5:30 AM and had totally cleared up by10:00 AM",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/13/2021,1.0,OTH,"levothyroxin, omeprazole, losartan ,hydrochlorothiazide , metoproloe, ezetimisimmmmmvastin, fluticasone propionate, Vitamin B, D, Calcium=D,multivitamin, fish oil, flaxseed oil, Berberine, iron",none,"HBP, high cholesterol ,, fatty liver disease, borderline diabetic",,none,"['Chest discomfort', 'Dyspnoea', 'Pulmonary physical examination', 'Wheezing']",2,MODERNA,IM 1047555,OH,72.0,M,Severe left leg pain above the knee,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,SCH,"AmLODIpine, acetaminophen 500 mg,Alever, Atorvastati 40 mg, Lisinopril 20 mg",None,CLL,,none,['Pain in extremity'],1,PFIZER\BIONTECH,IM 1047556,PA,79.0,F,"Red, slightly raised area, itchy and painful 2x1inches area Lasted for 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/07/2021,02/08/2021,1.0,PVT,,,,,Penicillin Soap,"['Erythema', 'Pain', 'Pruritus', 'Swelling']",1,MODERNA,IM 1047557,CA,21.0,F,"Flushed cheeks, red ears. BP 147/111 (pulse 77), BP 141/83 (pulse 66).",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/20/2021,0.0,UNK,,,,,,"['Erythema', 'Flushing']",UNK,PFIZER\BIONTECH,IM 1047558,CA,40.0,F,"complained of feeling weird and heart racing. HR 120s BP 168/78 at 1510. by 1600 HR down to 92, BP 142/76. Patient reported feeling better. Denied shortness of breath, chest pain and denied other symptoms. Advise to see primary care physician.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/20/2021,0.0,PUB,none,,none,,imetrex,"['Feeling abnormal', 'Palpitations']",UNK,PFIZER\BIONTECH,IM 1047559,MA,54.0,F,Noticed site of injection was itchy swollen and hard. Described as COVID Arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/22/2021,8.0,PHM,"Allegra, Aleve, Vitamins, Vitamin C, omeprazole, Iron supplement,",Ear ache die to fluid in ear began one week prior to injection,None,,Only allergic to surgical tape,"['Injection site induration', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA, 1047561,CA,43.0,F,Patient reported light headedness and cough 45 min after injection. with rest and oral fluids. resolved. over the next few days. patient reported increased fatigue and SOB. advised patient to seek medical attention for symptoms which she did today. reports she has now left sided chest discomfort. and left arm pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/11/2021,0.0,PVT,Unknown,Patient had unknown exposed to Covid -19 one moth prior to vaccination. Has had hx of cough,"anemia , Hx CHF 2015",,Benadryl,"['Chest discomfort', 'Condition aggravated', 'Cough', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 1047562,IL,67.0,F,Fever and extreme headache and aches from head to toe,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/03/2021,0.0,PVT,"EXTRA STRENGTH TYLENOL, GABAPENTIN, BLOOD PRESSURE MEDS",NONE,,,SULFA,"['Headache', 'Pain', 'Pyrexia']",UNK,MODERNA, 1047563,AL,46.0,F,"Body aches, fever, headache, ear pressure, chills, sweating.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/11/2021,6.0,OTH,,None,None,,,"['Chills', 'Ear discomfort', 'Headache', 'Hyperhidrosis', 'Influenza virus test', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",2,MODERNA,IM 1047564,NV,48.0,F,"On Sunday 2/21/21, I noticed a rash had formed on the right side of my lower stomach/hip. I applied lotion and when I got home from work at 7 p.m., the rash was more painful and prominent. I took Benadryl and applied Cortizone cream. This morning when I woke up, the rash was still there. All day I have periodically applied Cortizone cream to keep the itching and slight pain at bay. The rash consists of small red bumps over a 3 inch by 3 inch area.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/21/2021,3.0,PHM,,,,,,"['Pruritus', 'Rash']",2,PFIZER\BIONTECH,SYR 1047565,CA,52.0,F,"Within 15 minutes, left arm got got really cold - like ice. Lasted about 2 hours. The arm to the touch was warm but it felt like it was in ice bucket. They kept me for 2 hours. Started to resolve in those two hours but didn't go away completely. By evening it was mostly returned to normal. Next day, I woke up with flu-like symptoms - felt like I had the flu. Every hair on my head hurt; wanted to sleep; no appetite. Three in afternoon - I felt much better. As quickly as it came on, it went away quickly.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,Synthroid; daily vitamin,no,Hyper thyroid; asthma,,seafood; shellfish - tongue and throat closes,"['Decreased appetite', 'Head discomfort', 'Influenza like illness', 'Peripheral coldness', 'Skin warm', 'Somnolence']",2,PFIZER\BIONTECH,SYR 1047566,LA,78.0,F,"Approximately 10 minutes after receiving the Moderna vaccine patient started complaining of heart racing. After assessing the patient her heart rate was 117 and irregular, her bp was 172/100. We advised the patient to go to the emergency room for evaluation, she refused transport by ambulance but agreed for her friend to bring her.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,PUB,Unknown,unknown,Anxiety,,no known drug allergies,"['Heart rate irregular', 'Palpitations']",1,MODERNA,IM 1047567,,33.0,F,"After 7 days, a red rash near my injection site appeared. Minimal itching. No pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/14/2021,02/22/2021,8.0,UNK,None,,,,Just ceclor,"['Injection site pruritus', 'Injection site reaction', 'Rash erythematous']",1,MODERNA,SYR 1047568,IN,67.0,F,"2/15/21 evening, Pain down both legs, Skin feels electrified, hurts and is sensitive. Pain in lower belly & back. Fatigue 2/16/21 Pain legs, joint pain in knees, ankles & hips all day, Fatigue 2/17/21 Arthralgia & Myalgia all over, but mostly legs, and insomnia, Fatigue 2/18/21 - 2/19/21 - fatigue 2/20/21 - Nausea, no appetite, RASH on lower back, left to middle and down hip and leg and groin area (no itch), no fever, but hot and cold",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/15/2021,3.0,PHM,None,None,None,,None,"['Abdominal pain', 'Arthralgia', 'Back pain', 'Decreased appetite', 'Fatigue', 'Feeling of body temperature change', 'Hyperaesthesia', 'Insomnia', 'Myalgia', 'Nausea', 'Pain in extremity', 'Pain of skin', 'Paraesthesia', 'Rash']",1,MODERNA,IM 1047569,WI,57.0,F,"After getting my first covid vaccine on 1/13/21, I woke up the morning of 1/15/21 with vertigo, which I had never experienced before. It lasted 3 to 4 hours before resolving on it's own. After getting my second covid vaccine on 2/3/21, I again experienced an episode of vertigo starting the morning of 2/14/21 lasting 3 to 4 hours, then again the morning of 2/15/21 lasting all day until the morning of 2/16/21 before resolving on it's own.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/15/2021,2.0,PVT,armour thyroid 90 mg,none,none,,nkda,['Vertigo'],2,PFIZER\BIONTECH,IM 1047570,MO,31.0,M,"Fever, muscle aches, stomach cramps, chills, swollen lymph nodes in Jaw, Neck, and armpit.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,PVT,,,,,,"['Abdominal pain upper', 'Chills', 'Lymphadenopathy', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1047571,WA,,F,Death after stroke .,Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/11/2021,1.0,OTH,,,,,,"['Cerebrovascular accident', 'Death']",1,PFIZER\BIONTECH,IM 1047573,,46.0,F,"Sore throat, back pain and general fatigue on the 3rd and 4th day post second vaccine dose. Took Ibuprofen 400 mg 3 times daily x 2 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/19/2021,3.0,WRK,Vitamin B complex; Vitamin D3,,,,None,"['Back pain', 'Fatigue', 'Oropharyngeal pain']",UNK,MODERNA, 1047574,,39.0,F,?Covid toe? - wasn?t painful but slightly itchy in the beginning. Middle toe on each foot.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/27/2021,7.0,SCH,,,,,,['Pruritus'],UNK,MODERNA, 1047575,MN,73.0,M,"Moderna COVID-19 Vaccine EUA High temperature of 104.4, fatigue, chills, body aches. Symptoms lasted approximately 30 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/05/2021,1.0,OTH,"omeprazole 20mg, zetia 10mg, lopressor 50mg, brilinta 90mg twice a day, norvasc 10mg, metoprolol-er succinate 50mg, gabapentin 100mg five per day, remeron 15mg, aspirin 81mg",,"cardio vascular - 2 stents inserted 10/25/2020, COVID-19 November 1-15, 2020, stroke 2015, prostate cancer 2003",,"penicillin, ativan","['Chills', 'Fatigue', 'Pain', 'Pyrexia']",1,MODERNA,IM 1047576,CA,67.0,F,diarrhea low gas pain chills / sweating dry mouth sleepy no apatite cough with phlegm dizzy loss of bladder control blood clots in nose mucus,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,UNK,Lisinopril 25mg Baclofen Atarax lasix multi vitamins B vitamins,NONE,Thick blood CHF,,P.E.G. raw onions,"['Chills', 'Decreased appetite', 'Diarrhoea', 'Dizziness', 'Dry mouth', 'Flatulence', 'Hyperhidrosis', 'Productive cough', 'Somnolence', 'Thrombosis', 'Urinary incontinence']",1,MODERNA,SYR 1047577,OR,51.0,F,"I felt extremely tired and wiped out for 2 days, wouldn't have been able to work. Experienced hypothermia and a splitting headache. Thankfully it all went away on the morning of the 21st. The reason I am reporting this is because the app misses the days and hours directly after vaccination in their data collection that is reflecting this time frame. So their data is "" garbage in - Garbage out"".",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,OTH,"Hormone replacement, Vitamin D",None,none,,NKDFA,"['Fatigue', 'Headache', 'Hypothermia']",UNK,MODERNA, 1047578,FL,67.0,F,"I felt queasy at 5:15am. Had severe vomiting and diarrhea throughout the day, with a fever of 100 degrees. Tried taking a Pepcid, but got dry heaves. Had nine episodes of diarrhea. Called the doctor at 1:40pm who recommended tablespoons of water every 10 minutes. The nausea and dry heaves would not stop so my husband called the doctor again at 7:00pm who recommended the emergency room for an IV. But at 7:30pm, the nausea lifted, and I was able to sleep.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PHM,"Vitamins: B-12, D",None,Osteoporosis,,None,"['Diarrhoea', 'Nausea', 'Pyrexia', 'Retching', 'Vomiting']",2,MODERNA,IM 1047579,IN,77.0,F,"on 2/11/2021 AT 5:30pm Evening of the vaccination, my neck aching, and slight headache, When I woke the next day my arms and legs and neck and head ached, like I was coming down with a flu bug. Slight headache, Lymph nodes in neck painful and sore, legs and arms aching, flu like symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,OTH,"Clopidogrel 75mg, Lansoprazole 30mg, Metoprolol 50mg, Losartan 25mg, Reputa 140mg, Vascepa 1 gm, Pristiq 50mg, Hydroxyzine 12.5/25mg, Risedonate 35mg, Tolterodine 4mg, Ketorolac drops eyes, Multi Vitamin, Calcium, Vit C, Vot D3",,,Flu like symptoms,"Meds, Septra-sulfa","['Headache', 'Influenza like illness', 'Lymph node pain', 'Neck pain', 'Pain in extremity']",2,PFIZER\BIONTECH,SYR 1047580,MD,70.0,F,Rash at injection site and itchiness on arm beginning about 10 days after the injection. Lasted about 7 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/15/2021,10.0,PHM,"Synthroid, Anastrazol, Vitamin D supplement",,,"Shingrix vaccine, 2nd dose, Nov. 2020 - similar skin reaction",,"['Injection site rash', 'Pruritus']",1,MODERNA,SYR 1047581,CA,68.0,F,"Fever, flu like symptoms, muscle aches, fatigue and pain redness swelling in arm which spread over a large portion of my upper arm. Area on arm looked like 13 bee stings attacked and this swelling and redness lasted until today, 6 days after the vaccine. I have photos of my arm it was severe.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,UNK,None,None,None,,None,"['Erythema', 'Fatigue', 'Influenza like illness', 'Myalgia', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",2,MODERNA,SYR 1047582,AZ,31.0,M,"extremeties except for left upper arm patient had an approximately 8 cm diameter area on his left upper arm at the site of the injection that is red and slightly warm mildly tender without any fluctuance or induration noted. Initially had some soreness at the site and some mild redness but then subsided and the current area of redness developed 2 days ago. Patient does not have any systemic symptoms. Does have some local itching. Given diphenhydramine, hydrocortisone cream and antibiotic--Delayed reaction to covid vaccine and possible early cellulitis less likely-",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/19/2021,8.0,PVT,not known,not known,not known,,not known,"['Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Pruritus']",1,MODERNA,IM 1047583,NC,65.0,F,"tongue swollen, throat felt ""thick, heaviness in chest, palms of hands felt hot and tingly, started as we were leaving the vaccination location outside the hospital about 10 minutes after the shot. No treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,Citalopram; Telmisartin; Pravastatin; Acetaminophen with Codeine #3; Gabapentin; Vitamin D3 125 mcg; Centrum Silver; Celecoxib; Alendronate I know...I hate it,None,"Scoliosis with pain, osteoporosis, depression, HBP; high cholesterol",,None,"['Chest discomfort', 'Feeling hot', 'Paraesthesia', 'Swollen tongue', 'Throat tightness']",1,PFIZER\BIONTECH,SYR 1047584,ID,74.0,F,"Pt reported swelling of the tongue and lips to our outpatient clinic on 2/22. She said the symptoms started the day of the vaccine, and have persisted since. It is more mild then when they began, and has been managed with benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/16/2021,0.0,PVT,,B Cell Lymphoma,,,"Penicillin, Sulfa","['Lip swelling', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 1047585,MI,73.0,F,"Fatigue and brain fog, or dullness from Tuesday 02/09/2021 through Friday 02/12/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/09/2021,1.0,PVT,"Embrel, Methotrexate, levothyroxine, lipitor, Folbee, calcium, Vitamin D, nortriptyline, blood pressure med, zolpidem",None,"Rheumatoid arthritis, high cholesterol, high blood pressure, low thyroid, nerve pain","Fatigue after flu vaccine, Oct 2020, age 73",Sulfa,"['Fatigue', 'Feeling abnormal', 'Mental impairment']",1,PFIZER\BIONTECH,SYR 1047587,MD,40.0,F,"A golf ball sized lump developed almost exactly 1 week after the injection, at the site on arm. Bump is red, firm and itchy. Sore muscles in both upper arms that day as well as sore arm pits.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/15/2021,02/22/2021,7.0,PVT,none,none,"Heart murmur, essential tremor.",,"Doxylamine-dm Acetaminophen, Cephalexin and possibly amoxicillin.","['Axillary pain', 'Injection site erythema', 'Injection site induration', 'Injection site mass', 'Injection site pruritus', 'Myalgia']",1,MODERNA,SYR 1047588,IL,57.0,F,"After about 5 days a red circle about 3.5 - 4 inches in diameter appeared around the injection site. It is warm to the touch and itches. This is day 10 after the injection and the redness, warmness and itching are still there",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/17/2021,4.0,OTH,sertraline,none,none,,"penicillin and its derivative's, sulfa drugs, and cephalosporins","['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,SYR 1047589,NE,66.0,F,"When I first got the vaccine I was fine but as the day went on I felt soreness in my left arm with some stiffness in my neck. Later on in the afternoon, I started getting a headache, neck was getting stiffer and my back started to hurt. When I got home around 5 I fixed some dinner, within 30 minutes or less it felt like my stomach exploded, I was throwing up continuously, it was so intense, I tried sips of water to throwing it up as well. I could feel my esophagus burning up to my throat, and starting to feel like it was closing up. All during this time my eyes hurting and light really bothered me. I was to afraid to lay down, I got myself to calm down, and doing deep breathing. That seemed to help me. I was scared. I stayed home through the night and woke up the next day feeling better. I still have headaches to this day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,PVT,Linzess,Stomach and Colon problems but under control.,,,"demmoral, penicillin, latex","['Back pain', 'Eye pain', 'Fear', 'Headache', 'Musculoskeletal stiffness', 'Oesophageal pain', 'Pain in extremity', 'Photophobia', 'Throat irritation', 'Throat tightness', 'Vomiting']",1,MODERNA,SYR 1047590,,67.0,F,"Pain and tenderness in arm (wakes me up at night when I roll over) Fatigue, mild headache, achy all over, chills, joint pain, some nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/21/2021,02/22/2021,1.0,PHM,Duloextine - 60 mg. Calcium Multi vitamin Fiber Krill Oil Glucosamine / Chronatine UC III Cellular,none,Allergies to grasses and other pollens,,Erythromicin - diahrea,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Sleep disorder', 'Tenderness']",2,MODERNA,IM 1047591,MI,68.0,F,Scratchy throat. given Benadryl and relieved. No respiratory symptoms.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/22/2021,3.0,PVT,crestor synthroid,,,,Penicillin,['Throat irritation'],2,PFIZER\BIONTECH,IM 1047592,CT,44.0,F,Swelling in arm below injection site. Swelling was warm to touch and slightly itchy. Started about a week after injection and last for about 4 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/16/2021,7.0,UNK,Xyzal Loestrin,,,,Amoxicillin,"['Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA, 1047593,NY,67.0,F,Fever and chills Headache Dizziness pain in left arm muscle aches fatigue diarrhea Fever lasted through 02/22/21 at approximately 3:00pm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,SCH,Vitamin D,,none,,,"['Chills', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia']",2,MODERNA, 1047595,CA,76.0,M,"COMPLETE NUMBNESS IN RIGHT ARM, HAND & LEG & FOOT",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,OTH,ATORVASTATIN / FLOVENT / FLUTICASONE / MONTELUKAST / PROAIR / STIOLTO / VALSARTAN / PRILOSEC VITAMIN E / CALICUIM / TRIPLE FLEX / VITAMIN D / MULTI VITAMIN,,ASTHMA / COPD,,,['Hypoaesthesia'],1,MODERNA, 1047596,CA,78.0,M,Stroke and seizure ( In the past he had a stroke and seizure ) So this is not his first time and we are not sure if this is related to the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PHM,"Aspirin 81 mg one daily, Atorvastat 20 mg, one daily, benazepril 20 mg one daily, vitamine D3, 1000 IU one daily, Vitamine A 3,000 IU one daily, Krill oil 1,000 mg one daily and herbal vitamines and calcium supplement.",,"Open heart surgery to repair aorta aneurysm, aortic valve replacement, by pass. 2014. In 2018 one stent implant in location.",,Atenolot and beta adrenergic blockers ( Plavix ),"['Cerebrovascular accident', 'Condition aggravated', 'Laboratory test', 'Seizure']",1,MODERNA,SYR 1047597,FL,70.0,M,"fever lasting 4 days with highest 104.7 on day 3 with associated severe weakness/lethargy, hypotension and tachycardia. Required hospitalization (currently in the hospital) - hypoxic requiring BiPAP and two pressers for hypotension - in the ICU.",Not Reported,,Yes,Yes,,Not Reported,N,02/18/2021,02/19/2021,1.0,PHM,"aspirin, plavix, entresto, coreg, amiodarone, atorvastatin, ranexa, imdur, B12",none,"CAD, ischemic cardiomyopathy, HFrEF, HLD",,none,"['Asthenia', 'Bilevel positive airway pressure', 'Hypotension', 'Hypoxia', 'Intensive care', 'Lethargy', 'Pyrexia', 'Tachycardia']",2,MODERNA,IM 1047598,OK,51.0,F,"The patient had gone shopping in the store after receiving the Moderna Covid-19 vaccine and then returned to the pharmacy after about 10 minutes saying she wasn't feeling well. She reported feeling hot, that her lips were tingling, and stating she just felt weird. I had her sit in the immunization booth so I could tend to her without and audience. I gave her 10 ml of Benadryl because she mentioned her lips were tingling. I broke one of the instant icepacks for her and had her place it on the back of her neck and put her head between her knees. She reported feeling that her face felt hot, so I broke two more icepacks and had her sit up right and place the ice packs on the front of her neck. I stayed with her in the booth and talked to her until she felt better. I set the timer on my phone for 15 minutes. After 10 minutes she said she was feeling better and wanted to move to the waiting area. She was fine after the full 15 minutes and left our store. I estimate she remained in the store for approximately 30 minutes after receiving the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PHM,,,,,Latex,"['Feeling abnormal', 'Feeling hot', 'Malaise', 'Paraesthesia oral']",1,MODERNA,IM 1047599,NV,50.0,F,"Except for headaches everyday I felt like I had restless leg syndrome. Then, I had a Heroes outbreak, which I haven?t had in over ten years. Not sure if vaccine or not but rather odd, IMO.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/17/2021,7.0,SCH,"IB, Tylenol, Levothyroxine",Non,Thyroid Anemic,,None,"['Headache', 'Restless legs syndrome']",UNK,MODERNA, 1047600,TX,50.0,F,"Itchy, red rash at site of injection. Itching began 2/19/21. Rash is still present at time of report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,PHM,"Zoloft, Vitamin D, Melatonin",No illnesses,None,,NKDA,"['Injection site reaction', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 1047601,CA,44.0,F,"9 days after injection, injection site began to itch. The following day, while still mildly itchy, the skin around injection was slightly raised, had a warm feeling and was warm to the touch. Was approximately a 3.5 inch in diameter, perfectly circular area with the injection site in the center. Had a phone appointment with a physician. He ordered a prescription for Hydrocortisone 2.5% to use topically and advised me to take a once daily antihistamine, but to take it twice a day instead. The itchiness was less the next day and the area of red skin was much smaller, then gone by the end of that day(02/01). Stopped the cream and antihistamine. But area began to itch again on 02/03 and had a red blotchy look to the skin(approx 2? area). Again started Claritin twice a day. Itchiness and rash? we?re gone by 02/04, but I continued Claritin for another 2 days. Stopped Claritin on 02/06 and had no return of symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/30/2021,9.0,PVT,"Adderall, Hydrocodone, Hydroxyzine, Lithium, ibuprofen",None,"Depressive disorder, myofacial pain syndrome",,Cipro(antibiotic),"['Injection site pruritus', 'Injection site rash', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Rash macular']",UNK,MODERNA,IM 1047602,VA,24.0,F,Severe hive like rash from arm pit to wrists on both sides (top and bottom) on both arms,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/20/2021,8.0,WRK,Birth Control,None,None,,Gluten allergy,"['Rash', 'Urticaria']",2,MODERNA,SYR 1047603,WA,50.0,F,"slightly sore and warm at injection site for 48 hours after injection, but mostly went away. Then 7 days later, woke up to itchy, hard, round warm 3"" diameter lump, much bigger than anything I had immediately following the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/22/2021,7.0,OTH,none,none,none,,none,"['Induration', 'Injection site pain', 'Injection site warmth', 'Pruritus', 'Skin warm']",UNK,MODERNA,IM 1047604,MN,50.0,F,When injecting the vaccine the syringe/needle failed and vaccine started dripping down the patient's arm. She was offered another vaccine in the opposite arm and it was administered immediately.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,PUB,,,,,,"['Exposure via skin contact', 'Needle issue', 'Syringe issue']",UNK,MODERNA, 1047605,AK,27.0,F,"Patient reports having hives on her neck, starting the day after receiving her COVID19 vaccine. The hives lasted 2 days, and are no longer present. Patient also reports having dizziness at 3AM the day after receiving the COVID19 vaccines, when she got up to use the bathroom. She is concerned this is from the vaccine. Dizziness occurred once, no episodes of dizziness since. Patient also reports lingering fatigue, starting the night she received the vaccine, until today. (6 days total). Patient called on phone today (2/22/21). No treatment was given. Exam was recommended.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PVT,,,,,,"['Dizziness', 'Fatigue', 'Urticaria']",UNK,MODERNA,IM 1047606,ME,48.0,F,"Day 12 after moderna #2 I developed persistent burning and itching of palms and scalp. I then developed itching, hives at any pressure point all over body . I haven no hx of allergies, atopy or dermatographia . Symptoms have persisted. I?m taking Benadryl 50 qhs and loratidine during day due to severe itching. It disrupts my work. I am a physician and have not felt need to seek care. Reporting mild event for posterity.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/15/2021,12.0,PVT,Lexapro 10 mg,No,Metchondromas Dysthymia,,Penicillin Sulfa antibiotics,"['Impaired work ability', 'Pruritus', 'Skin burning sensation', 'Urticaria']",2,MODERNA,IM 1047607,MA,81.0,F,"Received 1st dose Feb 3 @ 7am. Felt minor soreness for 2 days. Felt fine afterwards. Feb 12 developed flu like symptoms, headache mild fever, tiredness. Symptoms progressed Sat & Sun. Monday she was speaking with her brother who said she wasnt making sense. Called ambulance & brought her to hospital. Ran CT scan, multiple MRIs and did spinal tap. Diagnosed with HSE enciphilitis. Has had multiple seizures. Very confused, can barely speak, doesnt recognize or understand who people are. Troubling motor skills.",Not Reported,,Yes,Yes,7.0,Not Reported,N,02/03/2021,02/12/2021,9.0,PVT,Multi vitamin,None,Emphysema,,None,"['Ataxia', 'Communication disorder', 'Computerised tomogram', 'Computerised tomogram head abnormal', 'Confusional state', 'Fatigue', 'Fine motor skill dysfunction', 'Headache', 'Herpes simplex encephalitis', 'Influenza like illness', 'Lumbar puncture', 'Lumbar puncture abnormal', 'Magnetic resonance imaging', 'Magnetic resonance imaging brain abnormal', 'Memory impairment', 'Pain', 'Pyrexia', 'Seizure', 'Speech disorder']",1,PFIZER\BIONTECH,SYR 1047608,AZ,29.0,F,29-year-old female presenting with signs and symptoms suggestive of delayed (1 week) inflammatory reaction to Covid 19 vaccine. Cellulitis is less likely. Given Benadryl and hydrocortisone cream,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/19/2021,8.0,PVT,unknown,unknown,unknown,,"NUTS, MELONS, WALNUTS, GRAPES, CARROTS, FRESH TOMATOES","['Cellulitis', 'Inflammation']",1,MODERNA,IM 1047609,MI,73.0,F,"The morning after she got her shot, she experienced sharp pain in thumb. It has been 6 days since she got the shot and she is still experiencing the sharp pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,PVT,"buspirone, furosemide, celecoxib, famotidine, vit d3, simethicone, probiotic, allerclear,",irritable bowel syndrome,"asthma, irritable bowel syndrome,",,"sulfa, iodine allergy",['Pain in extremity'],2,PFIZER\BIONTECH,IM 1047610,WA,80.0,F,Metallic taste in mouth immediately after receiving vaccine at 8:13 am.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,OTH,None,None,Multiple Myeloma - in remission,,None,['Dysgeusia'],1,PFIZER\BIONTECH,SYR 1047612,,57.0,M,24 Hours after shot got slight aches and low grade fever. Lasted 20 hours. Also had soreness in left arm where shot was given. Soreness is nearly gone after 48 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PVT,Multivitamin,,,,,"['Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 1047613,NJ,45.0,F,"The injection site feels itchy, and swollen a week after the injection was given. It is warm to the touch and hurts only a little. The initial soreness was gone 2 days after the shot was given. It was normal and then became sore again.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PHM,Breo inhaler Multivitamin Vitamin C,None,Asthma,,None,"['Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 1047614,MI,59.0,F,"Fainted on 2/11/2021, bowel incontinence, and vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/11/2021,1.0,OTH,"zoloft, abilify, hyoscyamine",none,"depression, ibs",,penicillin,"['Anal incontinence', 'Syncope', 'Vomiting']",2,PFIZER\BIONTECH,SYR 1047615,CT,72.0,F,Swollen at injection site Severe itch.Occurred 71/2 days (approx) after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/22/2021,8.0,PHM,"Placid losartin atrovstan prolia on12/22/2020 vitamin c,b12,mult,folic acid D",Tavr procedure 1/26 /21,Osteoporosis copd,,,"['Injection site pruritus', 'Injection site swelling']",1,MODERNA, 1047616,CA,46.0,F,"After patient received her second dose of COVID vaccine (Moderna) today (2/10/2021), she came back to staff after 9 minutes of observation, complaining of shortness of breath. Per staff, she was wheezing initially. She was taken to the triage area, supplemental oxygen applied, vital signs obtained: BP 164/98mmHg, HR 97, RR 21. O2 saturation initially marginal (87% on RA), corrected with 6 Liters of NC supplemental oxygen. BP stable in the 140-160's/80's range. HR initially in the 90s, then fluctuated between 100-120's subsequently. She was observed for 30 minutes, during which time she had 5 episodes of intermittent tachypnea, c/o feeling hot, dizzy and chest tightness. Patient states that she has h/o anxiety and ADHD, taking Adderall and Prozac. She had prior anxiety attacks but this one does not feel like anxiety per patient. She further reports that she had some reaction to her 1st dose of Moderna vaccine (on 1/9/2021) with headache, fever, hallucination, tiredness, loss of taste and smell on 1/10/2021. She was given 2 puffs of albuterol inhaler without significant improvement at 15:45pm. At this point, given no notable resolution of her cyclic tachypnea, EMS was called at 15:50. Care was transferred to EMS at 15:53. During this entire episode, there was no wheezing, no rash, no hive, no stridor. She was maintaining normal sensorium, talking to staff throughout, drinking sips of water.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/10/2021,02/10/2021,0.0,UNK,,,,,,"['Chest discomfort', 'Dizziness', 'Dyspnoea', 'Feeling hot', 'Tachypnoea', 'Wheezing']",2,MODERNA,IM 1047617,,43.0,M,Persisting hip joint pains even after 24 hours post vaccination. Hip pains are felt when getting up and walking. Not severe pain but achy and felt throughout the day.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,MIL,Ibuprofen 600mg daily,"12 hours after vaccination: I experienced body aches, joint pains, chills, and headaches which all went away after 1 day, except for joint pains. I am still experiencing achy hip joints aggravated by getting up and sudden change in position.",Pre-diabetes and sleep apnea,,NKDA,"['Arthralgia', 'Pain']",2,MODERNA,IM 1047618,MI,44.0,F,"Mild dizziness started within 5 minutes. Within 20 minutes my tongue started to swell, but only the front to middle part, not the back part. I was still able to breathe. After 25 minutes, I was unable to stand and nearly passed out twice trying to get to some place safe. I could not verbally communicate and was lacked strength to move. I started drinking as many fluids as possible with the assistance of family. Symptoms began to subside after 3 hrs. After 4 hrs, I regained strength and was not dizzy if I stayed in place. I continued to push fluids and rested. I needed to be careful not to drink anything too cold as i would develop the chills. The next day, there was no dizziness but I was very groggy. I continued to push fluids. I would develop a headache if I did not drink at 16 oz every hour. The following day, I was still groggy, but was functional and felt okay to drive.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,OTH,Multi-vitamin,None,"Asthma, syncope",,Xopenex,"['Aphasia', 'Asthenia', 'Dizziness', 'Dysstasia', 'Somnolence', 'Swollen tongue']",1,MODERNA,SYR 1047619,CO,38.0,M,"Small (dime sized) bright pink slightly bumpy rash appeared on upper arm about 2 inches away from where I received my injection. It was itchy otherwise not bothersome. I put a non medicated ointment on it overnight. Rash grew in size overnight. When I woke it was larger than a quarter with an extension or piece. It remained itchy and bright pink. I washed the ointment off and dried the rash. This time I applied an anti itch cream. The cream seemed to tone the itch a lot and also stopped it from growing in size. By the next morning (today) it was light pink in color and less itchy. Now (6pm) it is hardly visible any more. I can still feel it when I run my fingers over it softly and it still itches, but color and raised bumps have improved significantly.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,OTH,Adderall xr20mg Niacinamide 500mg Magnesium 250mg Zyrtec 24hour,None,Asthma Seasonal Allergies ADHD,,Percocet Shellfish,"['Injection site rash', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",1,MODERNA,SYR 1047620,CA,38.0,F,Pt developed chest pressure/ache about 15 minutes after vaccine given,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,OTH,Zovia Birth Control Pill,None,Bilateral Complex Ovarian Cyst Major Depressive Dosorder in full remission Secondary Female Infertility,,NKA,"['Chest discomfort', 'Electrocardiogram']",1,PFIZER\BIONTECH,IM 1047621,HI,49.0,F,"I noticed a slight red circular ring about the 4th day (February 14, 2021) but it was so slight, i couldn't tell if it really was a ring or not. I didn't really pay attention or notice it was ""blotchy"" and ""red"" with some small red areas feeling slightly warm to the touch until February 19, 2021. I took a picture of my arm on February 20, 2021 for documentation purposes. Today, February 21, 2021, the red blotchy patches/uneven circle looks lighter in color. I had a headache on February 18 and 19, however, I can't positively say it was from the COVID vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,02/14/2021,4.0,PUB,Birth control pills and over the counter daily vitamins,none known,none known,,Reaction to ant bites,"['Headache', 'Rash macular', 'Skin warm']",1,MODERNA,SYR 1047622,WA,52.0,M,"I contracted Covid 19 in mid October 2020 and I lost my sense of smell and taste. It took a long time to start coming back and was at about 60% of normal when I received the 2nd dose of the Pfizer vaccine. Four days after the shot my sense of smell and taste changed. From that day until present almost everything I smell and taste has a ""chemical"" taste and smell. Nothing smells normal and very few things taste good. Animal proteins are especially bad as well as some fruits and vegetables. Most foods make my stomach so upset that it is nearly impossible to eat. All smells are the same, nothing smells pleasant and most smells give me a light headache. I have lost over ten pounds since this started and I have general malaise.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/12/2021,4.0,PVT,none,none,none,,none,"['Abnormal loss of weight', 'Ageusia', 'Anosmia', 'Decreased appetite', 'Dysgeusia', 'Headache', 'Malaise', 'Parosmia']",2,PFIZER\BIONTECH,IM 1047623,NH,41.0,M,"Patients spouse reports he started to feel ""funny"" 5 mins post vaccination administration. Patients spouse called for assist when he he became unconscious at 7:25pm. He was found unconscious and failed to respond to a sternal rub. EMS called. Initial assessment: HR-weak pulse-not palpable, agonal, shallow breathing, and unresponsive. VS- BP 160/100 HR- 100 Wife used smelling salt to arouse the patient. He was confused after regaining consciousness. 7:37pm- EMS arrived and assumed care, transferring patient to a higher level of care.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,OTH,Extensive medication list for Mast Cell Activation Disorder,,Mast Cell Activation Disorder,,Morphine PCN Metformin Metronidazole,"['Agonal rhythm', 'Confusional state', 'Feeling abnormal', 'Hypopnoea', 'Loss of consciousness', 'Pulse abnormal', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 1047624,PA,61.0,F,"Injection site pain, redness, swelling Enlarged lymph nodes in Right axillary region Fatigue, headache, muscle pain/body aches, joint pain, chills, sweats, nausea, vomiting, fever Took Tylenol every 4 hours for 12 hours, rested All symptoms gone after 15 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PVT,"Lisinopril, Synthroid, Metoprolol, Simvastatin",None,"Hypertension, Hypercholesterol, Hypothyroid",,None,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,MODERNA,IM 1047625,NJ,47.0,F,"~13 hours post vaccination, symptoms consistent with acute intermittent porphyria exacerbation (attack) developed: severe abdominal pain, nausea, brain fog. Porphyria symptoms responded to porphyria-specific treatment (IV infusion with hemin (Panhematin) on both 2/10/21 and 2/11/21; analgesics). Porphyria symptoms lasted until 2/12/21. -On 2/10/21 also typical COVID-19-vaccine side effects: muscle and joint pain, fever (101.2F), chills. These resolved within one day. Previous mild COVID-19 (8 months prior to vaccination). Infection is a known trigger of porphyria attacks. Vaccination does not usually trigger porphyria symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/10/2021,1.0,PVT,"Lisinopril, Givosiran",,Acute intermittent porphyria,Low grade fever following booster rabies vaccine (HDC) in 1997,bandaid adhesives,"['Abdominal pain', 'Arthralgia', 'Chills', 'Feeling abnormal', 'Myalgia', 'Nausea', 'Porphyria acute', 'Pyrexia', 'Urine porphobilinogen increased']",UNK,PFIZER\BIONTECH,IM 1047626,CA,60.0,F,"Patient became unconscious and fell down on 2/18 after feeling extreme exhaustion and dizziness, cold sweat, nausea, head confusion, swollen arm on 2/17.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/17/2021,1.0,UNK,None,None,None,,None,"['Cold sweat', 'Dizziness', 'Fall', 'Fatigue', 'Loss of consciousness', 'Nausea', 'Peripheral swelling']",UNK,MODERNA,SYR 1047627,,20.0,M,"20 YOM with prior COVID vaccine Dec 2020 presents 4 days after COVID vaccination (First dose) with constant substernal chest pressure, ST early repol vs elevation in ST segment and troponins 11. Onset of chest pain occurred 3 hours after covid vaccine-- 5/10, constant, not positional. Transferred to cardiology inpatient for suspected myocarditis. No prior troponin obtained given prior covid illness.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/18/2021,02/18/2021,0.0,MIL,ibuprofen prn,20 YOM with COVID infection early dec 2020. No symptoms on day of vaccination.,None,,NKDA,"['Chest discomfort', 'Chest pain', 'Electrocardiogram ST segment elevation', 'Myocarditis', 'Troponin increased']",1,MODERNA,IM 1047628,WI,72.0,F,"One week after the injection, my arm started to itch and turned pink. On Saturday it was bright pink. The yesterday it was bright pink, from the injection site down to my elbow, and was warm and I had a swollen area just above the elbow on the inside of the arm. Today it is still pink, but not as itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/19/2021,7.0,PVT,"Humalog insulin, Zetia, cranberry, ginger root, D-3, multivitamin, AREDS2, fish oil, Latanoprost Ophthalmic Solution .005%, Florajen 3,.",None,Diabetic,,"tape, epinephrine in Lidocaine, Butalbitol-Acetominophen, Caffeine, Penicillin V Potassium 500 mg.","['Injection site discolouration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 1047629,IL,65.0,M,"Nausea, muscle ache, chills, arm soreness and head ache. I would describe my symptoms as serious, not mild or moderate. I felt that I was extremely ill for the first 45 hours. I ate very little and I could not bathe. I stayed in bed, leaving only to go to the restroom. On the 3rd day, I was much improved and I would characterize my symptoms as moderate. I was able to get up for short periods and I was also able to bathe. On the 4th day (today) I believe that I am symptom free with the exception of continued arm soreness at the injection sight.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,OTH,,Myelodysplastic Syndrome,"Obesity, Vertigo",,None,"['Abdominal pain', 'Chills', 'Decreased appetite', 'Headache', 'Injection site pain', 'Loss of personal independence in daily activities', 'Malaise', 'Myalgia', 'Nausea']",2,MODERNA,SYR 1047630,NY,57.0,F,"Felt like I had the flu: headache, mucles aches, joint pain, nausea, weakness, exhaustion, felt feverish but no actual fever. I took Tylenol every 6 hours. It helped my symptoms about an hour after taking the Tylenol then about 5 hours later the symptoms came back. The next day, I felt about 50% better and this evening I'm about 90% better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,OTH,Escitalopram 10 mg Divigel .5 mg,none,Celiac,,none,"['Arthralgia', 'Asthenia', 'Fatigue', 'Headache', 'Influenza like illness', 'Myalgia', 'Nausea', 'Pyrexia']",2,MODERNA,IM 1047631,NE,42.0,F,Two days after the 2nd injection I started to have chest pain and not feel right. I went to the Station where I volunteer. I did and EKG which showed Anterior Infarct. I went to the ER. They gave me 4 baby aspirin to take and some blood work. I was told the blood work showed elevated levels consistent with a blood clot as well. I had a CT scan to rule out a clot in my heart or lungs. Which it was negative. I was released and told to see a cardiologist in the next few days. I saw the cardiologist two days later who said I ended up with Pericarditis and that it should resolve on its own. I was feeling better until two days ago when I developed chest pain again. I again went to my fire station I volunteer for and did an EKG which showed Anterior Infarct. I am currently waiting for treatment from my cardiologist.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/13/2021,2.0,PUB,"Sertriline, Desvenlafaxine, Omeprazole, Vit C, Vit D, Elderberry",,,,,"['Blood test abnormal', 'Chest pain', 'Computerised tomogram normal', 'Electrocardiogram abnormal', 'Feeling abnormal', 'Fibrin D dimer increased', 'Myocardial infarction', 'Pericarditis']",2,PFIZER\BIONTECH,IM 1047633,AZ,28.0,F,"Chills, body aches, sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/22/2021,1.0,UNK,"Women's Multivitamin, Black Elderberry",None,None,,Sulfa,"['Chills', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 1047634,GA,91.0,M,Patient was admitted to hospital on 2-9-21 for urinary tract infection and tested positive for Covid. Developed pneumonia and expired on 2-12-21.,Yes,02/12/2021,Not Reported,Yes,3.0,Not Reported,N,01/25/2021,02/09/2021,15.0,PHM,,,,,,"['COVID-19', 'Death', 'Pneumonia', 'SARS-CoV-2 test positive', 'Urinary tract infection']",1,MODERNA,IM 1047635,NY,68.0,F,"Hives over thirty to forty percent of body, neck ,thighs arms, torso. took allegra D daily for three weeks..down to one twelve hour pull every twenty four hours",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/03/2021,1.0,PHM,levoxthrine- thyroid Flucousamine suphate calcium vit D,,,,"Following produce hives: aspirin, ibupropen ,tylenol, ,amoxycillian, codiene, red dye,dramamine",['Urticaria'],1,PFIZER\BIONTECH,SYR 1047636,,42.0,F,Palpaltations and dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,SEN,,,,,,"['Dizziness', 'Palpitations']",1,PFIZER\BIONTECH,IM 1047637,NJ,69.0,F,"Four hours after injection suffered severe body pains with nausea for several hours, and red rash about two inches in diameter popped up. The next day the injection site was red, with an expanding hard tissue underneath the skin, about five inches in diameter. Seven days later the rash was almost gone. Eight days later the rash came back with a vengeance, extremely itchy and expanding to three inches in diameter. As of this report, at ten days post-injection, the rash remains at three inches diameter and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,PUB,Multi-vitamin,,osteoporosis hyperacusis (painful sensitivity to sound) stomach aches,"Reacted to flu shot that was egg-based, at age approximately 40. Chest, arms and back itched for about 24 hours. No breathing pr","penicillen, codiene, morphine, most pain killers, egg-based injections, gluten, chocolate, artificial sweeteners lactose intolerant","['Injection site erythema', 'Injection site induration', 'Nausea', 'Pain', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 1047638,CT,26.0,F,"Area of red raised bumps in the shape of a square directly below injection site with accompanying pruritus. Onset is not known however, first noticed it 2 days after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/01/2021,,UNK,"Albuterol, nuva ring, iron",,Asthma,Hives at age 5 post the second Hep B vaccination,Heb b vaccine,"['Injection site rash', 'Pruritus']",2,PFIZER\BIONTECH,IM 1047639,NY,69.0,F,"A few hours after my vaccination, my arm became extremely sore and was extremely sore all night, and remained so the next day. I have a high pain tolerance, but my arm felt as if it had received a powerful injury, and was hard to lift without using my other arm. I also had a slight fever the next day, chills and muscle aches and fatigue. I am normally very active, but spent the day in bed. The next day I felt much better although my arm was very sore for another day or two. Then, the evening of the 21st of Feb., my arm, at the vaccination site became very itchy and was painful to touch in that area. I slept well but woke with the same itchiness, and soreness, and now tonight, Feb. 22nd, that area is still itchy and a bit sore. But I have not had the swelling and redness that I am reading about with Covid arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,UNK,none,none,none,"yearly flu vaccines, always have flu symptoms for about 4 days after.",none,"['Chills', 'Fatigue', 'Injection site pruritus', 'Musculoskeletal disorder', 'Myalgia', 'Pain in extremity', 'Pyrexia', 'Vaccination site pain']",1,MODERNA,IM 1047640,FL,78.0,M,"I had an ocular migranes 2 hours, 5 hours and 20 hours after the injection. I usually have ocular migranes abour once per month.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,PHM,Too many to list,none,none,,none,['Migraine with aura'],UNK,MODERNA,SYR 1047641,MI,52.0,F,"Moderna covid-19 vaccine eua. About 15 min after injection I felt hot (very unusual for me), then dizzy, racing heart, weak then very nauseous. I told the nurse. He asked me to lay down. I did not get worse. After 20 min or so I sat up and did not feel worse. Just stable nausea and dizzy. I asked if I could leave. After verifying I had people at home I was allowed to go. I felt exhausted and nauseous for the rest of the day. I was confused the next morning about what day it was and had some hives at injection site. I felt normal after figuring out what day it was. I walked 8 miles and aside from the hives at the injection site was normal. One week later I had headache, exhaustion and had an uncomfortable rash at the site. The rash is still on my arm. Should I get the second dose?",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,PVT,None,None,Hashimoto thyroid,"DPT, high fever, age 40","Many, bee and other wasp stings, latex, crustaceans, erythromycin, ceclore, sulfur","['Asthenia', 'Confusional state', 'Dizziness', 'Feeling hot', 'Headache', 'Injection site rash', 'Injection site urticaria', 'Nausea', 'Palpitations']",1,MODERNA,SYR 1047642,CO,38.0,F,I began having headaches nightly 2 nights after my second dose. On 2/7 my blood pressure was about 135/90. On 2/9 my blood pressure was 150/90 or 95 and then it increased by the time I went to my doctor?s office that afternoon. I had severe pre eclampsia on 2/8 and was induced and delivered 2/9 with a 34 week old baby. She had an infection and pulmonary hemorrhage.,Not Reported,,Yes,Yes,2.0,Not Reported,N,02/01/2021,02/03/2021,2.0,PVT,"Pantaprazole for heartburn from pregnancy, prenatal daily vitamin, 1000 IU vitamin D",None. Had a normal pregnancy. Had pregnancy heartburn that was normal.,None. Had occasional pre hypertension prior to pregnancy but never treated for it.,,Noneq,"['Blood pressure increased', 'Exposure during pregnancy', 'Headache', 'Induced labour', 'Infection', 'Pre-eclampsia', 'Premature delivery', 'Protein urine present', 'Pulmonary haemorrhage']",2,PFIZER\BIONTECH,SYR 1047643,CA,43.0,M,7 day post-shot still experiencing pain in arm focused at site of injection. Waves of extreme fatigue requiring me to sit down and overwhelming desire to sleep (unusually) three times day. First dose.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/15/2021,0.0,PVT,Losartin Pottassium 25 MG (1 per day) for hypertension,None,Hypertension Gata 2 deficiency (asymptomatic),,"Allergic to ace inhibitors (e.g., Lisinopril, dry cough)","['Fatigue', 'Injection site pain', 'Somnolence']",1,PFIZER\BIONTECH,IM 1047644,VA,67.0,F,"34 hours (2:00 am on 2/19/21) after injection I woke up with stomaching cramping and nasuea. At 3:00 a.m. I was dizzy and had uncontrollable shaking over entire body for approximately 45 minutes. The nausea continued throughout the entire day on 2/19/21. I contacted the Department of Health today, but whomever I spoke to did not seem interesed in hearing about it and did not ask any questions or for any information.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/19/2021,2.0,PVT,"Vitamin D, Biotin, Allergy pill",None,None,,None,"['Abdominal pain upper', 'Dizziness', 'Nausea', 'Tremor']",2,PFIZER\BIONTECH,SYR 1047645,CA,52.0,F,"Extreme lupus flare up, followed by complete debilitating period of about 1 hour. Husband found me with muscles fully relaxed to a point of him being concerned and started talking to me. I was conscious but felt too heavy to move at all. With effort I could move and answer coherently. It was as if I had melted on the couch buy was fully awake.................",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/22/2021,4.0,PUB,NONE,NONE,I HAVE LUPUS,,PISTSCHIOS AND SUNFLOWER SEEDS,"['Condition aggravated', 'Movement disorder', 'Systemic lupus erythematosus']",UNK,PFIZER\BIONTECH, 1047646,MI,40.0,F,"February 8- 10:00 pm nauseous February 9- sore arm, nausea, headache, 1:00 low grade fever, 4:00 fever of 102.9, stomach pains February 10- sore arm, nauseous, headache, onset of diarrhea, 100-101 fever. Stomach pains February 11- sore arm, nausea, headache, diarrhea, stomach pain, low grade fever February 12- February 19- nausea, headache, diarrhea, low grade fever February 20-21 nausea, diarrhea, shortness of breath February 22- fever of 100.8, nausea, diarrhea, chills, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/09/2021,1.0,PVT,"Lithium Carbonate- 1 Am, 1 Pm 900 mg total Pristique 2tablets 200 mg total Pristique 1 tablet 50 mg total Deplin 1 tablet 15/90.314 mg total Saxenda",Perfectly healthy prior to vaccine.,None.,,Doxycycline,"['Abdominal pain upper', 'Chills', 'Computerised tomogram normal', 'Diarrhoea', 'Dyspnoea', 'Headache', 'Nausea', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative']",2,MODERNA,SYR 1047647,NM,29.0,M,ON THE NIGHT OF THE IMMUNIZATION - FEVER STARTED. NEXT DAY HOT AND COLD SWEATS AND THEN DIARRHEA AND NAUSEA STARTED..,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/12/2021,0.0,PHM,NONE,NONE,NONE,,NO,"['Diarrhoea', 'Feeling of body temperature change', 'Hyperhidrosis', 'Nausea', 'Pyrexia']",1,MODERNA,IM 1047648,PA,47.0,F,Developed 3 to 4 itchy hives on my legs and thigh 1 to 4 days after receiving my first vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/28/2021,1.0,PHM,None,No,No,,No,"['Pruritus', 'Urticaria']",1,MODERNA,IM 1047649,MI,37.0,F,Severe joint pain all over began around 10 hours post vaccine most of which resolved around 24 hours later. Unfortunately I have continued hand and wrist joint pain for weeks now making it hard to complete tasks sometimes. I will need to see a doctor when my schedule allows it.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/23/2021,2.0,PVT,"Biotin, MVI, melatonin",None,None,,None,['Arthralgia'],2,PFIZER\BIONTECH,IM 1047650,OR,48.0,F,"Approximately 10 days after injection the injection site had a nearly circular red hive; only periphery, not complete to center. It also appeared to have a slight hardness at the center of hive and although it was hard it was not very painful/sensitive to the touch. The entire hive area, approximately 2 inches in diameter, was itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/18/2021,10.0,PVT,Hydrocodone/Acetaminophen 10-325mg Ibuprofen 1200mg Sertraline HCL 150mg Bupropion HCL ER (XL) 150mg Sudogest 60mg Loratadine 10mg Diphenhydramine HCL 50mg Vitamin D3 125mcg,None,"Seasonal allergies (dust, pet dander, grasses) Back issues Depression",,None,"['Injection site induration', 'Injection site pruritus', 'Injection site urticaria']",1,MODERNA,SYR 1047651,WV,88.0,F,Moderna COVID-19 Vaccine EUA Experienced mild injection site tenderness when rubbed for 48 hours after injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,PUB,Levothyroxine ? 1 50 MCG pill daily; Metoprolol ? 1 25 mg daily; Hydralazine ? 3 25 mg daily; Amlodipine? 1 1/2 5 mg daily; Cevimeline HCL ? 3 30 mg daily; Aspirin ? 1 81 mg daily; Travatan eye drops ? 1 drop in each eye daily; Hydroxychlor,None,"Discoid Lupus, Sjoegren syndrome with unspecified organ involvement, Hypothyroidism, osteoarthritis, rheumatoid arthritis, scoliosis, transient ischemic attack (caused left side weakness), Atrial fibrillation, Corneal epithelial and basement membrane dystrophy, Dry eyes, bilateral, MGUS (monoclonal gammopathy if unknown significance), glaucoma, hypotension, vaginal vault prolapse, incontinence urinary, cystocele/rectocele, diverticulosis, hearing loss requiring hearing aids",,Morphine,['Injection site pain'],2,MODERNA,SYR 1047652,FL,64.0,M,"Immediate pain in left arm day of vaccination. Next day pain radiating down left day. Worsting day bay day. 12 days later, unable to walk. Went to hospital 2/15/2021, for inability to walk and radiating pain down both legs. At that time, found out that i possibly diabetic in addition to the pain.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/03/2021,02/03/2021,0.0,PVT,Cinemet Amantadine Multi-vitamin Hydroxizine,,Parkinson?s,,Celebrex,"['Blood test', 'Gait inability', 'Immediate post-injection reaction', 'Injection site pain', 'Lumbar radiculopathy', 'Pain', 'Pain in extremity', 'X-ray']",2,PFIZER\BIONTECH,SYR 1047653,,,U,Swollen bump on arm near injection site Patient received first dose of pfizer vaccine and when time for second dose three weeks later theres was still bump on arm near injection site Patient reports possibly reaction from bandaid and reported no pain and it doesnt bother her but appearance look swollen and so second dose was not administered Patient was told to see doctor to confirm safety of second dose,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,Patient report having flu shot years ago that left a mark on right arm,,['Injection site swelling'],1,PFIZER\BIONTECH,IM 1047654,FL,90.0,F,"Patient became incoherent for a few seconds while sitting in a chair in the observation area. Pharmacy manager went to observe patient and ask how she was feeling. Patient's head started to droop to the side for a few second and her shoulders made shrugging movements for a few seconds. During this time I called 911, while individual waited with the patient seated in the chair. Patient became more coherent in a few seconds and could speak and smile normally. Ambulance came and patient went with paramedics.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PHM,none listed other than 2 moderna vaccines,none listed,Atrial Fibrillation listed on consent form as long term condition,,none listed,"['Incoherent', 'Muscle twitching', 'Posture abnormal']",2,MODERNA,IM 1047655,CT,72.0,F,large rash on arm. 4inches by 3 inches Itchy.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/17/2021,5.0,PUB,none,none,none,,none,"['Rash', 'Rash pruritic']",1,MODERNA,IM 1047656,MN,43.0,F,"Upper respiratory symptoms developed about 18 hours after vaccine dose, including sneezing, runny nose, itchy face and eyes, as well as itching at injection site.. Fatigue onset at that time as well. Treated with Benadryl, neti pot, Flonase, warm compress and rest. Symptoms alleviated after 2 days. Injection site is still slightly red and irritated 8 days after vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/14/2021,02/15/2021,1.0,OTH,"Lexapro, 5 mg daily Linzess, 72 mcg daily women's multivitamin calcium/magnesium/zinc supplement",none,"irritable bowel syndrome, mild depression and anxiety",,none,"['Eye pruritus', 'Fatigue', 'Injection site erythema', 'Injection site irritation', 'Injection site pruritus', 'Pruritus', 'Respiratory symptom', 'Rhinorrhoea', 'Sneezing']",1,MODERNA,IM 1047658,CA,71.0,F,"I woke up at 3 am on the 9th day since I had received my first vaccination and discovered I had a 2 inch rash below the injection site of my left arm. It is very itchy and somewhat red. Sent photos to Dr. today (2/22) and had a virtual visit with her , She directed me to this site so that I may report the adverse reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/20/2021,9.0,PUB,Repatha 140 mg: 1 injection every 2 weeks Fosamax 70 mg: 1 tablet weekly Aspirin 81 mg: 1 tablet daily Trintellix 7.5 mg: every morning Percocet 5 mg: 1/2 - 1 tablet prn for pain every 4-6 hours Neurontin 100 mg: 1-3 capsules prn dail,No,Disc deterioration disease of lower back,,"Penicillin (rash) Sulfa (rash) Clindamycin (rash) Macrodantin (rash) Codeine (severe headache, upset stomach, extreme anxiety) Vicodin (increased pain levels, extreme headache, nausea and vomiting) Statins (horrible muscle cramps in both arms and legs, flu symptoms, and extreme fatique Bee stings (as a child incurred extreme swelling and difficult breathing when stung by a bee) Cilantro (mouth sores) Chipotle (mouth sores) Mango (mouth sores)","['Injection site rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 1047659,GA,76.0,F,Did not go back to the hospital.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/19/2021,1.0,PVT,"Simvastatin, Omeprazole, Levothyroxine, Losartan, Hydrochlorothiazide, Folic Acid, Methotrexate, Plaquenil, Ropinirole.",,,,Yes,['Unevaluable event'],UNK,MODERNA, 1047660,NY,41.0,F,"Chills began within 2 hours of injection. Fever rose to 101 within 6 hours and lasted for approximately 48 hours. Chills lasted the entire time the fever lasted. After the fever came down to below 100, bodyache became more recognizable. Most unusual pain, which began while the temperature was above 100, was in the muscles connecting my neck to the shoulders, more severely on the left-side where the injection was administered. The pain was so severe that it felt the muscle was tense, numb and itchy at the same time. The severity of the pain made it feel like the throat was closing up even though I knew it was not true because I did not have trouble breathing. This pain lasted (in similar intensity) approximately about 36 hours. After this, on the third day, most of the pain was gone but I experienced dizziness, nausea, and diarrhea. I had a loss of appetite the whole time (over 72 hours) I was experiencing these side effect symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,SCH,None,None,None,,None,"['Chills', 'Diarrhoea', 'Dizziness', 'Muscle discomfort', 'Muscle tightness', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Throat tightness']",2,MODERNA,SYR 1047661,PA,44.0,M,"The morning after receiving vaccine I worked out lifting weights and jumping rope. After about a half hour I suddenly stopped sweating became very chilled (shivering), weak, very nauseous, felt rapid heart rate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/09/2021,1.0,OTH,"Sertraline 50mg, omeprazole 20mg",none,,,seasonal allergies,"['Asthenia', 'Blood glucose increased', 'Blood sodium normal', 'Blood test normal', 'Chills', 'Electrocardiogram normal', 'Heart rate increased', 'Lymphocyte percentage decreased', 'Nausea', 'Neutrophil percentage increased', 'X-ray normal']",2,PFIZER\BIONTECH,SYR 1047662,NY,50.0,F,"Red, hot, slightly raised swelling around vaccination site, appeared 8 days after vaccination, slightly itchy, currently the red patch is the size of an open palm, has been visible for 3 days. Not painful or debilitating, just abnormal and slightly uncomfortable",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/19/2021,8.0,PUB,"Escitalopram, atorvastatin, medroxyprogesterone, vitamin d, Zyrtec, coenzyme Q",None,High cholesterol,,Pollen allergy,"['Injection site erythema', 'Injection site pruritus', 'Vaccination site discomfort', 'Vaccination site swelling', 'Vaccination site warmth']",1,MODERNA,SYR 1047663,VA,38.0,F,"Chills, fatigue, hallucinations, shortness of breath, chest pain, and body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,WRK,Cranberry pills for healthy bladder,None,None,,Sulfa,"['Chest pain', 'Chills', 'Dyspnoea', 'Fatigue', 'Hallucination', 'Pain']",2,PFIZER\BIONTECH,SYR 1047664,RI,18.0,F,"3 days after I got the vaccine I started losing flavors, everything tastes like acid metal, everything smells the same as it tastes, and it?s being like that since the moment that start",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/16/2021,4.0,PHM,None,None,None,,None,"['Dysgeusia', 'Parosmia']",1,PFIZER\BIONTECH,SYR 1047665,CA,72.0,M,"Severe pruritic rash involving trunk and extremities, including palms and soles and roof of mouth. started 8 days after vaccination and persistent",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/18/2021,8.0,PVT,"Amlodipine 10 mg, Atorvastatin 20 mg, Hydroxyurea 500 mg, Losartan-HCTZ 100-12.5 mg, Sildenafil 50 mg prn, Aspirin 81 mg, Vitamin D3 1000 units",,"Polycythemia Rubra Vera, Coronary Artery Disease, Hypertesnion, Chronic Kidney Disease Stage 3, lattice degeneration of retina",,Allergic to penicillin,"['Rash', 'Rash pruritic']",1,MODERNA,IM 1047666,CA,38.0,M,Arm swollen below the injection site chills body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/21/2021,2.0,UNK,,,,,,"['Chills', 'Injection site swelling', 'Pain']",2,MODERNA,SYR 1047667,FL,74.0,M,"WHEN I AWOKE ON THE 8TH DAY AFTER BEING VACCINATED, AT 07:00 MY LEFT ARM ITCHED AT THE POINT OF INJECTION. THIS GOT WORSE AS THE DAY PROGRESSED. AROUND NOON AN AREA FROM THE INJECTION SITE TO THE CREASE IN THE ELBOW HAD TURNED RED AND SWOLLEN. IT ALSO TURNED FLABBY, LIKE MY BICEP WAS A WATER BALOON. THE REDNESS, SWELLING AND ITCHING WORSENED UNTIL BEDTIME AT 11:00. AT 06:00 THE FOLLOWING MORNING ALL 3 SYMPTOMS SEEMED TO BE RECEEDING. THIS WAS CONFIRMED BY MY WIFE. BY EVENING, EXCEPT FOR AN ANNOYING ITCH, ALL APPAERED NORMAL.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/13/2021,02/20/2021,7.0,PHM,"HYDROCHOLOROTHIAZAD, LOSARTAN, AMIOLODIPINE, ATORVASTATIN, OME OMEPRAZOLE, DOXYCYCLINE, HYDROCORTIZONE",NONE,"HYPERTENSION, ACID REFLUX, CHOLSETERAL",,NONE,"['Injection site erythema', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling']",1,MODERNA,IM 1047668,WV,92.0,F,"Pharmacy provided medical center with COVID vaccines in order to conduct a vaccine clinic on 2/22/2021. After review and data entry, it was found that an incorrect birthdate was documented by medical center for patient. Medical center confirmed the correct date of birth when called for clarification. With further investigation, it was concluded that the patient had received a third dose of the COVID vaccine today 2/22/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,SEN,,,Heart failure and breast cancer,,Morphine and Phenobarbital,['Extra dose administered'],3,MODERNA,IM 1047669,IL,62.0,F,"01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Called dr and had a Telemed call with NP on Tues. 01/26. Predisone and Benadryl was prescribed. Thurs. 01/28 Call to let them know that it wasn?t working. I went into the office for one shot of Solumedrol. This help and they were gone. They gave me second dose of Predisone to take in case it came back and to continue the Benadryl. 02/8 Second vaccine. Hives began that night: arms, torso, thighs, hair. Call the Dr. on 02/10 and suggested I go to an allergist. Went to allergist on 02/11 she said to only take one Predisone, Allegra one am and one at noon, then take zertek at nighttime. The Predisone created a major brain fog, I had to stop. Saw the allergist on 2/18, she agreed to get off the Predisone. 02/11 I passed out in the am and when I woke up with vomit running down my face. Still suffering with hives this entire time. 02/17 my face, lips, tongue started to swell and I had chest pain for 90 minutes. My feel swelled and I have hives so bad on my feet I could not walk or put on shoes. 02/20 Woke up with sweat on my chest. My hands were so swollen I had to have my wedding ring was cut off . 02/21 I went to the Urgent Care and received a shot of Solumedrol. They said this should last me for a few days. 02/21 woke up 3 time throughout the night soaked in sweat.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/23/2021,22.0,SEN,Synthroid .75,Non,None,,Sulfa,"['Chest pain', 'Feeling abnormal', 'Gait inability', 'Hyperhidrosis', 'Laboratory test', 'Lip swelling', 'Peripheral swelling', 'Swelling face', 'Swollen tongue', 'Urticaria', 'Vomiting']",2,PFIZER\BIONTECH,SYR 1047670,CA,73.0,F,"Severe proteinuria, hematuria, severe edema 3+ in bilateral legs and thighs",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/20/2021,4.0,PVT,"Metformin. Olmisartan, levothyroxin, norvasc, glimipiride, neurontin, Prevacid, vit D, albuterol inhaler, Flovent inhaler, Lipitor, trajenta",None,"Asthma, diabetes, HTN, osteoporosis",,Tylenol with codeine,"['Haematuria', 'Metabolic function test', 'Oedema', 'Protein urine', 'Proteinuria', 'Urine analysis']",1,MODERNA,IM 1047671,FL,68.0,F,"I had filler under my eyes, injected in mid-December 2020. After Pfizer vaccine 2 my under eye area puffed up where the filler was placed and has remained puffed up now, 25 days after the 2nd shot. No signs of resolving. Has remained as it was on February 5th 2021 no change. Not good.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/01/2021,4.0,UNK,Wellbutrin- Armour Thyroid,NONE,NONE,,NONE,['Periorbital swelling'],2,PFIZER\BIONTECH,SYR 1047672,MI,44.0,F,Nine days after the vaccination I developed a red itchy rash around the injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/22/2021,9.0,SCH,Flonase,None,Spondyloarthritis,,"Cipro, Sulfa, Penicllin, Doxycycline","['Injection site rash', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 1047673,,28.0,F,"Severe fatigue, body aches, migraine, weakness, hallucinations, vivid dream",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/22/2021,1.0,UNK,Multivitamin,none,none,,none,"['Abnormal dreams', 'Asthenia', 'Fatigue', 'Hallucination', 'Migraine', 'Pain']",2,MODERNA,IM 1047674,UT,51.0,F,"Ongoing sporadic nausea, bloating, stomach cramps. Severe fatigue. Noticed left side supraclavicular node swollen to 2 cm a few days after vaccination--no change so far. Continued feeling of pressure, heartburn or chest pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/09/2021,1.0,PUB,None.,None.,Mild Sjogren's Syndrome (dry eye & mouth).,,GI allergy to Zithromax antibiotic.,"['Abdominal distension', 'Abdominal pain upper', 'Chest pain', 'Discomfort', 'Dyspepsia', 'Fatigue', 'Lymphadenopathy', 'Nausea']",UNK,MODERNA,IM 1047675,VA,44.0,M,"After I get the second dose of vaccine, I assume my body began it's immune response immediately. I felt fine. But 5 days later my whole body was sore as a result of inflammed kidneys. A week later my kidney function was at 18%. While I have a history of IgA nephropathy, I have no other medical conditions and had not had any kidney episodes in over 2 years (I don't get sick.) But the immune response from the covid vaccine resulted in significantly dimished kidney function - considerably worse than any previous episode. The theory is that the vaccine triggered an immune response causing IgA to build up in my kidneys at a much higher rate than any previous time.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/03/2021,1.0,MIL,"Lisonopril, fish oil",none,IgA Nephropathy.,,none,"['Blood test', 'Condition aggravated', 'Pain', 'Renal impairment', 'Urinary tract inflammation', 'Urine analysis']",UNK,PFIZER\BIONTECH,SYR 1047676,AZ,60.0,F,Large red bump 2 inches below vaccination site. Seems to be getting bigger.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,OTH,"Vit D, biotin",None,None,,Mild allergy to penicillin Allergic to juniper Allergic to horsehair,"['Vaccination site joint erythema', 'Vaccination site swelling']",2,PFIZER\BIONTECH,IM 1047677,VA,36.0,M,"Patient felt light headed, clammy, and nauseous. The patient was brought to the medical clinic where he laid down and was given benadryl 12.5mg.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PHM,,,,,,"['Cold sweat', 'Dizziness', 'Nausea']",1,MODERNA,IM 1047678,OH,66.0,F,"Eight days after the shot, I developed itching at the site of injection. Today - day 9 - it is painful (mild), warm, and firm to the touch at the region surrounding the injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/22/2021,9.0,PHM,"aldactone, metoprolol, glucophage, levothyroxin, lexapro, atorvastatin, miralax",none,"insulin resistance, high blood pressure (controlled), hypothyroid. sleep apnea, elevated triglycerides",,mango,"['Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,SC 1047679,NY,66.0,M,"Severe arm pain at area of injection about 9 hours after shot (bedtime). Next morning very severe total arm, head and joint pains, total fatigue, mild fever, no appetite. Unable to get out of bed except once to urinate which was a painful struggle. Next morning most symptoms subsided greatly. Only a mild headache and moderate arm pain remained. As of this writing headache is gone but moderate arm pain at injection site continues.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,SCH,na,none,none,,na,"['Arthralgia', 'Decreased appetite', 'Fatigue', 'Headache', 'Injection site pain', 'Mobility decreased', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 1047680,AZ,67.0,F,"About one week post-vaccination, I noticed itching and when I scratched, I noted a lump where it itched. This was Feb. 11th at about 2pm. When I got home, I removed my shirt and noticed I had a red blotch and lump at the vaccination site. It no longer itches, but I still have the red splotches and a slight lump under the skin. I want to know if it is safe to get the second vaccine. I already plan to get it in the opposite arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/11/2021,7.0,OTH,"Amlodipine, spironolactone, metoprolol, primidone, duloxetine, tizanidine, levothyroxine, rosuvastatin, pantoprazole, vitamin D, probiotics, multiple vitamin, flonase.",None,"Degenerative arthritis, hypothyroidism, hypertension, GERD","Tetanus, raised red area, with edema from shoulder to hand. Received in 1993.",Codeine IVP dye Tetanus,"['Mass', 'Pruritus', 'Rash macular', 'Vaccination site joint erythema', 'Vaccination site mass']",1,PFIZER\BIONTECH,IM 1047681,WA,21.0,F,My left shoulder and collarbone area got really swollen and then I discovered a small lump right above my collarbone that is painful to touch. The pain and swelling has lessened but it has been over a week and the lump is still there.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/11/2021,02/12/2021,1.0,UNK,Birth control,,,,,"['Injection site mass', 'Injection site swelling', 'Tenderness']",2,PFIZER\BIONTECH, 1047682,DC,64.0,F,"Patient complained of stiffness/right side; headache, dizziness after receiving first dose of Pfizer; Comprehensive nursing assessment done including vital signs, pain, neurological status. Patient stated she had no difficulty swallowing. She was given water. Vital signs remained stable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PVT,,,hypertension asthma sleep apnea,,"peanuts, azithromycin,","['Dizziness', 'Headache', 'Musculoskeletal stiffness', 'Pain']",1,PFIZER\BIONTECH,IM 1047683,IL,29.0,M,Right jaw/TMJ pain for about 8 days after,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/14/2021,02/14/2021,0.0,PVT,Zinc and multivitamin,None,None,,None,['Pain in jaw'],UNK,MODERNA,SYR 1047684,,79.0,M,"Moderna COVID-19 Vaccine EUA muscle pain/joint in the right arm, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/22/2021,1.0,PUB,,,,,,"['Arthralgia', 'Myalgia', 'Pain']",2,MODERNA,IM 1047685,CA,70.0,F,"Exactly 1 week after receiving the vaccine, my right upper arm (the one in which I received the shot) started itching a lot. I noticed there was a lumpy swelling under my skin and the skin was red and warm. I have now had the itchy swelling for 4 days and think it is going down a bit. It never hurt, just itched. I am telling you this so you can warn others to expect this mild reaction so they will not worry. I looked it up and it is called ""covid arm"". It relieved me that I am not alone with this condition. Feel free to contact me with any questions. Thank you!",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,PUB,none,none,none,,sulfa,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 1047686,CA,67.0,F,"got vaccine at 9:45 , 5-6 minutes later on waiting room, started having tingling on my face , got blurry vision , and felt weak, started having fine tremors , my hands became so cold . nurse was called , they took me back . my blood pressure got rose to 155 mmhg and o2 sat 99% . my blood pressure was up for 20 minutes . Then kept me there for one hour , then I had another episode of blurry vision , cold handed and fine tremor. They checked my blood pressure which was uyp again . then I took tylenol and a physicien over there recommended benadryl 25mg po which i took it. then around 1 pm i had another episode of coldness and weakness which was not intense and severe as the first time and resolved on her own in 10 minutes . then they let me leave . of fnote , My left arm got swollen but no redness. swelling resolved in 2 days . meanwhile I continued to have weakness,fatigue and subjective fever for next 48 hours .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/14/2021,02/14/2021,0.0,PVT,"multi vitamine , rosuvastatin 5 mg , D3 , biotin , magnesium twice a week , but on the day of vaccination didn't take any of those medications .",none,"dibetes type 2 diet contreolled , not on treatment migraine","flu shot , 2 days later , developped fever ,cough and chest tightness, received z pack and then got levaquine . this happened tw",epinephrine norco vicodine cortisone seafoods,"['Asthenia', 'Blood pressure increased', 'Paraesthesia', 'Peripheral coldness', 'Peripheral swelling', 'Pyrexia', 'Tremor', 'Vision blurred']",1,MODERNA,IM 1047687,CA,72.0,F,"Received #1 dose as stated. Next day, 1/27/21, 9:00am , had mild joint pain to both legs, & arms, & slightly tired. Shortly after that , while driving, had nausea, & muscle aches to legs & arms. Reaching family members home, could barely carry bags with each arm, due to pain in joints, and to muscles, getting worse. Through the next 6 hrs. had moderate to severe pain to joints, & muscles & gradually severe fatigue. Took 1 Tylenol 650 mg for pain. Also, checked temperature thru out this time, with only mild 99.5 temp. Vaccine site gradually became swollen, with increased pain. Was doing work on computer, but could not continue, so left for my home, & went to bed, to sleep. Lt. Arm started becoming red, with severe soreness & swelling by 1/28/21, 2 days after vaccine. Vaccine was given very high on my arm, almost shoulder area. All Symptoms continued for about 10 days, including to vaccine arm, which continued with redness & soreness for 2 weeks. My physician was notified. She advised NSAID before #2 dose, but I already take NSAID daily (Meloxicam), so don't think I can take another NSAID. I have been taking Tylenol 650mg at least twice a day, for increased joint & muscle pain, since vaccine. My 2nd dose, originally scheduled for 2/23/21 has been rescheduled to 2/27/21 due to no vaccines available.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/27/2021,1.0,OTH,Metoprolol ER 25 mg Atorvastatin 10mg Escitalopram 10mg Meloxicam 15mg,none,"Arthritis: Lt knee, both hips, Rt shoulder, and Rt. knee Replacement",,Adhesive tape; NKDA,"['Arthralgia', 'Body temperature increased', 'Erythema', 'Fatigue', 'Impaired work ability', 'Incorrect route of product administration', 'Myalgia', 'Nausea', 'Pain in extremity', 'Vaccination site pain', 'Vaccination site swelling']",UNK,MODERNA,IM 1047688,IL,69.0,F,"At 3:30 pm (2 hours after the injection) my arm at the injection site started to hurt and I felt light-headed and had chills, These symptoms continued, plus I became exhausted and my joints hurt. My stomach was queasy. By the next morning, my joints hurt so much it was difficult to roll over in bed, and all the other symptoms were still there and worse. I did not have a fever. I developed a headache. All I could do was lie in bed; sitting up felt exhausting. By evening of that day, my joint pain was lessening and my stomach felt somewhat better. By the following morning, I felt normal, basically. So in total, about a day and a half of bad reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PHM,"Trazadone (100 mg, once/day), daily multivitamin, fish oil, glucosamine/chondroitin, calcium",None,None,Moderna first shot on 1/22/2021; the only adverse reaction was a swollen itchy lump at the injection site for a week,None,"['Arthralgia', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Mobility decreased', 'Nausea']",UNK,MODERNA, 1047689,OR,89.0,F,Shingles outbreak on right let and buttocks,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/21/2021,3.0,OTH,metFORMIN 500 mg 24 hr tablet four tablets by mouth every day with breakfast SM ASPIRIN ADULT LOW STRENGTH 81 MG EC tablet one tablet by mouth every day indications: pvd FIBER-LAX 625 mg tablet one tablet by mouth every day indications: bo,,Alzheimer's and dementia,,none,['Herpes zoster'],1,PFIZER\BIONTECH,SYR 1047690,AZ,53.0,F,"About 12 hours later I had a mild headache, body aches, chills that lasted another 18 hours. 36 hours after the shot I felt a lump under my left armpit and there was visible swelling about the length of my fist. The lump was sore and pain could be felt with touch and with squeezing my arms across my breasts. 4 days after the shot, the lump under my arm isn't very painful but there is still some swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/19/2021,1.0,PUB,Losartan Potassium tab 100 mg 1x daily Hydrochlorothiazide CAP 12.5mg 1x daily Clonidine HCL Tab .1 mg 1x daily Spironolactone TAB (Aldactone) 25 mg 1-2 daily OTC Magnesium 400 mg 1x daily Potassium Chloride ER 20 meq 1x daily Famo,none,Kidney - thin basement membrane Blood pressure Diabetes - 49 Cholesterol Arthritis Neck/back ? discs Depression Infertility Feet problems Weight Thyroid Nodules,,none,"['Chills', 'Headache', 'Injection site mass', 'Injection site pain', 'Injection site swelling', 'Pain']",2,PFIZER\BIONTECH,IM 1047691,TN,56.0,F,"Large red inflamed rash around injection site. Hot to touch. Tender to touch. Pain with range of motion, itching. 9 days post moderna vaccine. Ice and ibuprofen- effective.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/22/2021,9.0,SEN,Lecythyroxine Lexapro,,Hoshimotos,,Alpha gal syndrome- allergic to meat,"['Injection site inflammation', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth', 'Pain', 'Rash erythematous']",1,MODERNA,SYR 1047692,NY,73.0,F,"I was extremely sleepy. I went to sleep Saturday night, got up at 8 am. At 9:30 am I was so sleepy I could hardly walk. I went to bed and slept for 7 hours without waking up. When I got up I felt better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,OTH,No medication was previously taken.,no,Diabetic,,pork and penecillin,"['Gait disturbance', 'Somnolence']",2,PFIZER\BIONTECH,IM 1047693,,79.0,F,Heart Palpitations,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/15/2021,02/16/2021,1.0,UNK,,,,,,['Palpitations'],UNK,PFIZER\BIONTECH,IM 1047694,OK,72.0,M,"2 weeks after receiving the vaccine the inside of mouth (both cheeks and upper and lower lip areas) became numb and possibly swollen. After a couple of days my mouth improved. My mouth was almost well by Feb16. On Feb 10 I received the Moderna covid boster vaccine. On Feb 17 my mouth again became numb and swollen. As of this date 2/22/2021 my mouth is again improving and is nearly well. I visited my Primary Care Doctor on Feb 19, 2021. We decided to wait and see if this gets better on its own. If not I will see an Ear, Nose, and Throat Specialist.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/28/2021,14.0,PUB,"cavedilol, lisinopril, amlodipine, atorvastatin, aspirin,",none,heart disease,,blue kidney dye,"['Hypoaesthesia oral', 'Mouth swelling']",2,MODERNA,SYR 1047695,KY,52.0,F,"16 hours after injection, had chills, temp 99.8, body aches that lasted about 16 hours. Then had 2 small nosebleeds that lasted less than 1 minute-one about 48 hours after injection and one about 72 hours after injection. About 79 hours after injection, noticed petechiae on bilateral lower legs only . . Notified my PCP the next day. No nosebleed on day 4 after injection and petechiae stable - maybe spread a little but still below the knees. ( Had previous COVID-19 infection that symptoms started around 11/29/2020)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,PVT,"Levothyroxine , Mobic, Excederin prn, Advil prn, Elderberry OTC, MVI, Vitamin D, Calcium, Flonase",Sinus congestion,Hypothyroid Plantar Fasciitis Sinus congestion Reactive Hypooglycemia,,NKA,"['Body temperature increased', 'Chills', 'Epistaxis', 'Pain', 'Petechiae']",1,PFIZER\BIONTECH,IM 1047696,IL,69.0,F,Covid Arm after both vaccinations,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/24/2021,02/22/2021,29.0,OTH,Xanax,None. HAD SECOND VACCINATION YESTERDAY (Moderna for both) AND IT APPEARS THAT I HAVE COVID ARM AGAIN,"Granuloma Annulare, Psoriasis",,None,"['Dermatitis allergic', 'Type IV hypersensitivity reaction']",UNK,MODERNA, 1047697,CO,36.0,F,"Fatigue, itchy arm,",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,02/15/2021,5.0,WRK,None,None,Obesity,,Amoxicillin,"['Fatigue', 'Pruritus']",1,MODERNA,IM 1047698,TN,29.0,F,Right arm arm pit swollen where it looks like an extra titty. It?s sore and will ache . I have a tingle that runs down it every once in a while to my little pinky . It?s weaker than my left side . I vaccinated 12/23 12/31 lump in tight armpit came up 1/4 got in with MD she said heat compress soak in Epsom salt baths Tylenol 1/20 came near 29 past 1st shot called to ask if I still needed to take second one she told me no I was sent for blood work I can?t member the date . still there went back to md Had CT done on 2/9 CT reading very vague in my opion and also the rheumatologist opion lol . Just states inflamed lymph nodes benign. She also sent me to rheumatologist due to sed rate elevated. He thinks it?s elevated due to arm swollen. He also told me I need contact y?all cause he dose not think it?s autoimmune even though he checked me throughly and has ran labs today . He said he believes it?s from vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,02/22/2021,61.0,PUB,Sertraline 100 mg Hctz 50 mg Omeprazole 60 mg Potassium 10 meq,No,High blood pressure Anxiety depression Acid reflux Infertility issues,,None,"['Axillary pain', 'Computerised tomogram abnormal', 'Hemiparesis', 'Lymphadenitis', 'Oedema peripheral', 'Paraesthesia', 'Red blood cell sedimentation rate increased']",1,MODERNA,IM 1047699,NY,57.0,F,First 2 days couldn?t move my arm it was red swollen and hard as a rock. The pain was less day 3 redness spot is getting bigger at point of injection still hard to touch,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,UNK,Montelukast one daily,,,,,"['Erythema', 'Induration', 'Injection site erythema', 'Injection site pain', 'Musculoskeletal disorder', 'Peripheral swelling']",UNK,MODERNA, 1047700,MN,45.0,F,"Sore arm, swollen arm pit lymph nodes -day 2 and now. Fatigue-day 2 til now. Nausea and dizziness-day 3. Chills-day 4.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,PVT,"Wellbutrin, claratin, lipator, valtrex, vitamin d, metformin",None,Type 2 diabetes,,"Sulfa, penicillin","['Chills', 'Dizziness', 'Fatigue', 'Lymphadenopathy', 'Nausea', 'Oedema peripheral', 'Pain in extremity']",2,PFIZER\BIONTECH,SYR 1047701,FL,21.0,F,"Besides normal side effects that are well known, I got blood blisters in the gums of my mouth. I have very good oral hygiene and have never had a cavity in my life, and no recent changes to any medications or anything. One of them popped, and it was filled with blood.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,PVT,?Banana Bag Oral Solution -- 1 packet -- 1 per day ?Zofran ODT-- 8 MG -- every 8 hours PRN Metaxalone -- 800 MG -- 3 times per day ?Chelated Magnesium -- 400 MG -- 1-2 times per day ?Vitamin C -- 500 MG -- 4 times per day ?Dextromethorphan,"Ehlers-Danlos Syndrome Type 3, Dysautonomia/POTS, Complex Regional Pain Syndrome, Primary Immunodeficiency/Hypogammaglobulinemia, Mast Cell Activation Syndrome, Cranio-cervical/Atlantoaxial Instability, Median Articuate Ligament Syndrome, Intestinal Dysmotility, Factor 8, Ventricular Septal Defect, small mitral valve prolapse","Ehlers-Danlos Syndrome Type 3, Dysautonomia/POTS, Complex Regional Pain Syndrome, Primary Immunodeficiency Subclass 1, Mast Cell Activation Syndrome, Cranio-cervical/Atlantoaxial Instability, Median Articuate Ligament Syndrome, Intestinal Dysmotility, Factor 8",,"Mast Cell Activation Syndrome patient: Known triggers are Brazil nuts, albuteral, augmentin","['Blister rupture', 'Gingival blister']",2,PFIZER\BIONTECH,IM 1047702,,20.0,M,"Chills and bodyache following the #2 of moderna. Pt is tachycardic. Otherwise unlabored breathing. Steady gaits. 20 yo M w/ no known chronic medical conditions, p/w frontal HA, dry mouth, myalgias, fatigue, and nausea since last night. Received the COVID vaccine yesterday afternoon. No photophobia, vomiting, diarrhea, abd pain, cough/congestion, CP, SOB.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/17/2021,1.0,MIL,UNK,,,,NKA,"['Chills', 'Dry mouth', 'Fatigue', 'General physical condition abnormal', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Tachycardia']",2,MODERNA,IM 1047704,CA,29.0,F,"I took Sumatriptan 50mg 3 hours prior to vaccination because of a migraine attack. Migraine symptoms were relieved in 2 hours but still experienced some side effects of the medication such as dizziness. I got my 2nd dose of Moderna at 18:10, 2/17/21. I started to experience tingling sensation in my head at 23:00. The tingling was unilateral in the left parietal and left occipital areas. On 2/18/21, I experienced dizziness, fatigue, general weakness, bad headaches, and nausea. I took Acetaminophen 600mg at 22:00, and symptoms were gone on 2/19/20. But my migraines were more frequent since vaccination, but i did not take any medication for that. Today (2/22/21), some post vaccination symptoms are back, including headache, dizziness, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/17/2021,0.0,UNK,"Sumatriptan 50mg, 3 hours prior to vaccination for migraine attack",migraines,no,,no known allergy,"['Asthenia', 'Condition aggravated', 'Dizziness', 'Fatigue', 'Headache', 'Migraine', 'Nausea', 'Paraesthesia']",2,MODERNA,IM 1047705,NJ,65.0,M,"Had minor itching/ pins and needles feeling sporadically at different locations of my body starting about 1 hour after vaccine injection. Pins and needles feeling grew less and less each day. All symptoms gone by day 6 after vaccine injection. As a side note, my last flu shot was about 8 years ago and I had the same symptoms after the shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,UNK,Levothyroxine 112,None,Minor Asthma,Had same effect after receiving a flu shot about 8 years ago,"Aspirin, penicillin, sulpher drugs, bananas, apricots.","['Paraesthesia', 'Pruritus']",1,PFIZER\BIONTECH, 1047706,IA,48.0,F,"erythema, warmth, pain in deltoid in region of the vaccine starting 2 days after. 14x20 cm in diameter. Still with some redness as of 2/19 but improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/27/2021,01/29/2021,2.0,PVT,,,,,,"['Vaccination site erythema', 'Vaccination site pain', 'Vaccination site warmth']",UNK,MODERNA, 1047707,CA,70.0,F,"On Wednesday, February 17, 2021 around 7:00 pm I had a pounding headache that I never experienced before. The next morning headache began again and started vomiting at 7:45 a.m. thru out the morning until 11:30 a.m. I could not eat anything , tried eating a piece of toast & after one bite the vomiting began again. I vomited again at 3:15 p.m. Tried again to eat white rice and immediately began vomiting again. On Thursday morning had a slight headache with no vomiting. Friday I felt OK, just weak from all the vomiting. Saturday morning I felt Okay, then suddenly I felt dizzy and though I was going to faint. My daughter immediately told me that she was driving me to the ER because I was pretty dehydrated. Was diagnosed with dehydration at the ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/17/2021,2.0,OTH,Jardiance 10 MG,"Sinus infection on January 29, 2021",,,No,"['Asthenia', 'Blood test', 'Dehydration', 'Dizziness', 'Electrocardiogram', 'Feeding disorder', 'Headache', 'Impaired driving ability', 'Vomiting']",2,MODERNA, 1047708,TX,65.0,F,"Fever, joint aches, nausea, chills, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/22/2021,1.0,OTH,"Atenolol, atorvastatin, Acetaminophen/ibuprofen, loratadine",none,"hypertension, high triglycerides",,none,"['Arthralgia', 'Chills', 'Headache', 'Nausea', 'Pyrexia']",UNK,MODERNA,SYR 1047709,,79.0,F,"to ER on 2/19/21 breathing difficulty, hoarse voice , chest pain, skin itchy, headache, edema, body joint pain, elevated B/P",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,OTH,"simvastatin, gabapentin,relafen, keflex",,"UTI, osteo., neurothopy",,"PCN,codiene,sulfa, mobic, doxicillin, biaxin, plaqienel levefloxin","['Arthralgia', 'Blood pressure increased', 'Chest pain', 'Dysphonia', 'Dyspnoea', 'Headache', 'Pruritus']",1,PFIZER\BIONTECH,SYR 1047710,OH,44.0,F,"Woke up on 2nd day after shot with a red swollen line running from arm pit on injection arm down to elbow on underside of arm, the line is about 9 inches in length and 1/2 inch wide. It hurt to lift arm, getting better as the day goes on. Not other issues.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/22/2021,2.0,PUB,"Lisinopril 10mg, estradiol 1mg, vitamin c 1000 mg, magnesium 400 mg, turmeric curcumin 2250 2x, fish oil 3600mg 3x, centrum, b12 1000mg, potassium 40 mg, loratadine 10 mg, d3 50 mg 2x, by 25 mg, pycnogenol 100mg 3x , flonase 50 mcg",None,"High blood pressure, obese",,None,"['Erythema', 'Oedema peripheral', 'Pain', 'Peripheral swelling']",2,MODERNA,IM 1047712,FL,51.0,M,"Indurated red rash that started around the patient?s left eye just over 24hr after the second vaccine dose. It progressed to an ulceration by the weekend (3-4 days post vaccine), then additional rashes developed on the cheek below it. Additional rashes developed on both arms which progress to bullae.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/11/2021,1.0,PVT,"Synthroid 200 mcg once daily Singular 10 mg once daily Repatha IM once every 2 weeks Lisinopril 10 mg once daily Vitamin D 5,000 IU once daily Mycophenolate mofeil (was on 1500 mg/day that was decreased to 500 mg at bedtime then discontinu",,Lupus diagnosed in March 2021 Hypothyroidism since 2003 Hypercholesterolemia Seasonal allergic rhinitis,Tdap in April of 2018,"Multiple allergies to foods, pollen, mold based on skin tests","['Blister', 'Induration', 'Rash', 'Rash erythematous', 'Ulcer']",2,MODERNA,IM 1047713,,41.0,M,"fever,chills,bodyache. Fever,chills and bodyache since last night. Wants to get COVID test done. Pt does not want to be seen by ED provide.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/18/2021,2.0,MIL,UNK,Gout. Seasonal Allergic Rhinitis,,,PENICILLIN G,"['Chills', 'Pain', 'Pyrexia']",1,MODERNA,IM 1047714,WV,71.0,F,"Injection site had a hard lump, had and extremely large red circle around the site, and was hot and itchy for about two weeks. Also caused an elevation in blood pressure and fluid retention for about two weeks. Slight headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/29/2021,1.0,OTH,"Losartin, Metoprolol ER, Felodipine, Hydrochlorothiazide, As;rin, Lovaza, Vitamin B12, Vitamin D3, Super B Complex, Move Free Ultra",none,"Allergies, diverticulitis, Hiatal hernia, hypertension, high cholesterol, Mitral valve regurgitation, VSD, Left Renal Angiomyolipoma",Repatha,"Cipro, Levaquin, penicillin, Tramadol, Naprosyn, Acetaminophen, Statins, Repatha, Tape Band aids, Padding on braces, Strawberries, Corn and corn products, dust mites, molds, tree and grass pollens","['Blood pressure increased', 'Fluid retention', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 1047717,WA,70.0,F,"Bad headache, chills, low fever night of injections. Followed by 2 days of major fatigue and brain fog.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/22/2021,7.0,PVT,"Effexor, K-tab, Pradaxa",none,"depression, pulmonary embolism (12/10/20), hypo-potassium, non-allergic rhinitis",headache for 2 hours after injection and large itchy red spot on arm starting 7 days after injection,none,"['Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Pyrexia']",2,MODERNA,IM 1047718,TX,45.0,F,Swelling around injection site ongoing and it?s been a week Hardness in the tissue around injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/13/2021,2.0,PUB,Magnesium,,Vertigo Seasonal environmental allergies Obese,,Codeine,"['Injection site induration', 'Injection site swelling']",1,MODERNA,SYR 1047719,WA,70.0,F,Rash and pain at injection site. Also warm to the touch. Started today. 14 days after first vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/22/2021,14.0,PHM,Baby aspirin. Turmeric. Multi vitamin. Vitamin C and B12,None,None,,None,"['Injection site pain', 'Injection site rash', 'Injection site warmth']",UNK,MODERNA, 1047720,MN,65.0,F,Ongoing right shoulder pain and increased migraines,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,PVT,None,None,None,,None,"['Arthralgia', 'Migraine']",UNK,PFIZER\BIONTECH,IM 1047721,OH,62.0,F,"My second dose triggered cluster headaches, which I have not had for almost 40 years. They began the day after my shot and have intensified over the last 12 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/11/2021,1.0,UNK,"Gabapentin, Zyrtec, Aspirin",None,W-p-w cardiac arrhythmia I had cluster headaches between age 10 and age 25,,None,"['Cluster headache', 'Headache']",2,MODERNA,SYR 1047722,NY,54.0,F,"Starting several days after receiving the second dose of the Moderna Covid-19 vaccine I developed muscle spasms on the left side of my neck which is on the same side that I received the vaccine. This does not feel like anything like I have ever had before. Multiple muscles in my left neck feel very stiff, almost like a dystonic reaction. This continues so far 1 & 1/2 weeks after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/08/2021,2.0,PUB,None,None,Celiac,,"Foods (non-anaphylactic) Gluten, Corn, Sweet Potato, Watermelon","['Dystonia', 'Muscle spasms', 'Musculoskeletal stiffness']",2,MODERNA,IM 1047723,NC,31.0,F,"Shortness of breath, tachycardia (HR 130), and redness all over body.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PVT,None,None,"Undifferentiated connective tissue disease, oral allergy syndrome",Tachycardia and flushing with Moderna vaccine #1,"Penicillin, sulfa drugs, valium, tree nuts","['Dyspnoea', 'Erythema', 'Tachycardia']",2,MODERNA,IM 1047724,AZ,18.0,F,An hour after my vaccine I noticed that my arm was red where I got the shot. It got bigger and bigger. The biggest is what it is currently at 8pm on the 22 of Feb 2020.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,UNK,None,None,None,,Amauxacillin and sulfa,['Injection site erythema'],2,PFIZER\BIONTECH,SYR 1047725,MA,25.0,F,Circular shaped rash. Red appearance. Slightly raised edges. Mild inflammation,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,PHM,Xulane Birth Control patch,None,Seasonal allergies; hay fever,,None,"['Erythema', 'Inflammation', 'Rash', 'Swelling']",1,MODERNA,SYR 1047726,AL,53.0,F,"The day after receiving the shot, my arm hurt and it was swollen at the site of the injection. With each passing day, my arm felt more normal. Nine days after receiving the 1st Moderna shot, I woke up with my left arm hurting and itching at the site of the injection. Upon investigation, I discovered that my left arm was swollen at the site of the injection and that the swollen area had fever. These symptoms lasted for several days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,02/07/2021,9.0,WRK,Losartan Potassium Prilosec Trivora One a Day Gummies,,High Blood Pressure,,,"['Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,SYR 1047727,NY,70.0,F,"Approximately 14 hours after receiving the vaccine, I woke up at 2:15 a.m. feeling pains in my chest middle and extending through to my upper back. The pain encompassed the span of my upper chest and back from one arm to the other. I experienced very rapid heartbeats that I could feel throbbing from my head to my chest. I was hesitant to move or rise from my bed because of the pain. At 3:40 I called 911. They did an EKG and I was told that my heart was fine. My blood pressure was 180/90. I chose not to go to the hospital but to call my doctor when his office opened up at 9:00 a.m. in approximately 5 hours. My doctor had me come into his office. I had another EKG which was fine and he sent me to have a Cat Scan. the same day which was also fine. My doctor spoke to me and said that he felt that this was due to side effects of the vaccine. I doubled up on my Acid Reflux medicine, taking 80 mg daily for four days through Monday 2/22/2021. I could not sleep well for three days after the vaccine experiencing pain in my chest and could not breathe deeply without feeling it. Then I steadily improved and today I can take deep breaths with little pain. I also experienced muscle pain in my left shoulder and neck but used Mineral Ice on my neck and was relieved in one day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,PHM,Omeprazole caps 40 mg. daily Simvastatin tabs 20 mg daily Metoprolol Succinate tabs 25 mg daily Fish Oil 1300 mg daily Iron tabs 65 mg daily D3 1000iu daily Women?s multivitamin dietary supplement gummies,,Acid reflux Cholesterol,Swelling of the arm in injection site.,None that I was aware of.,"['Back pain', 'Chest pain', 'Computerised tomogram normal', 'Electrocardiogram normal', 'Heart rate increased', 'Myalgia', 'Pain in extremity', 'Painful respiration', 'Pulse abnormal', 'Sleep disorder']",UNK,MODERNA, 1047728,CA,32.0,F,Large red itchy spot on arm. Thought it was a bug bite at first. No treatment as I?m currently breastfeeding.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/15/2021,5.0,PUB,Postnatal vitamins,None,None,,None,"['Erythema', 'Maternal exposure during breast feeding', 'Pruritus']",1,MODERNA,SYR 1047729,NV,57.0,M,Developed Shortness of Breath about four days after being vaccinated. Went to the ER 2/21. Had bloody fluid removed from around his heart or lung 2/22//2021.,Not Reported,,Yes,Yes,2.0,Not Reported,U,02/16/2021,02/20/2021,4.0,OTH,"Off methotrexate and Pradaxa: Taking amlodipine, Ertapenem IV 1 gram daily, and Metoprolol Tartate","Atrial Fibrillation, HTN, Chronic pain. Pt has a pacemaker removed in January 2021 secondary to an infection, followed by removal of pacemaker wires and revision of a pacemaker pocket early February 2021. He has been receiving daily IV ABT (Ertapenem )and has Negative Pressure Wound Therapy over the surgical site. Bandages are changed every three days. A PICC in inserted into the left upper arm. He became short of breath within three to four days after receiving Moderna COVID-19 primary. On Saturday, February 20th his wife shared that he becomes winded easily. He was seen Sunday, February 21st for wound care and was later sent by EMS to Hospital. Blood was reportedly found in the left lower lung lobe. He has been flown to Hospital, and today has a pericardial or pneumothoracic tap per his wife.","Atrial fibrillation, chronic pain 2* arthritis, HTN.",,None,"['Dyspnoea', 'Pericardial effusion', 'Pleural effusion']",1,MODERNA,IM 1047730,IN,44.0,F,10 cm erythematous circular rash with raised edges,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/21/2021,9.0,OTH,"zinc, vitamin C, vitamin D",None,None,,KNDA,"['Rash erythematous', 'Rash papular']",1,MODERNA,IM 1047731,NY,37.0,F,"Chills, nausea, headache, joint pain 2/7 and 2/8.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/07/2021,1.0,PVT,,,Asthma,"Flu shot 2019- fever, chills, headache, fatigue",Seasonal allergies,"['Arthralgia', 'Chills', 'Headache', 'Nausea']",2,MODERNA,SYR 1047732,DC,29.0,F,"The morning after the vaccine, pt noted low grade fever and general weakness, syncope with loss of consciousness for undetermined time period, facial trauma resulting in fractures of maxilla and teeth",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/13/2021,1.0,WRK,"Recent Medrol taper, prn maxalt",recent daily headaches,,,penicillins,"['Asthenia', 'Electrocardiogram normal', 'Face injury', 'Jaw fracture', 'Loss of consciousness', 'Pyrexia', 'Syncope', 'Tooth fracture']",2,PFIZER\BIONTECH,IM 1047733,CA,35.0,F,"I developed a small hive/bite looking spot around the injection site. It began as about 1inch and has grown to cover the whole upper arm. It is red around the outside and lighter in the middle. Is seems to be growing, it is warm to the touch, and slightly itchy. Not other side effects",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/16/2021,8.0,PUB,Metformin,None,Type 2 Diabetic,,Penicillin,"['Injection site erythema', 'Injection site pruritus', 'Injection site urticaria', 'Injection site warmth']",1,MODERNA,SYR 1047734,CO,47.0,F,"Covid arm. Red, hard, slightly swollen and slightly itchy circle around the vaccine area on the left arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PHM,Orthotrisprentic - oral contraceptive,None,None,,None,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA, 1047735,WY,51.0,F,"Within 15 minutes of receiving vaccine patient developed SOB, was put on oxygen initially and O2 sats improved for about 10 minutes until O2 sats began dropping again at which time patient was transitioned to a non-rebreather and given IM epi 0.3mg.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/31/2021,02/10/2021,10.0,PVT,"lisinopril, spironolactone, zoloft",None,Ventricular septal defect,,bacitracin and sulfa- rash,['Dyspnoea'],2,MODERNA,IM 1047736,TX,51.0,F,The day after felt very fluish. Very fatigued and had swollen lymph node above right collar bone.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/03/2021,2.0,SEN,None,None,None,,None,"['Fatigue', 'Flushing', 'Lymphadenopathy']",1,PFIZER\BIONTECH,SYR 1047737,OR,74.0,F,"Six days after receiving her vaccine, she developed a larger than palm-sized raised, red, irregularly bordered area at the injection site. She said it was painful to touch. She was having no other adverse reactions.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/18/2021,6.0,PHM,,,,,NONE,"['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 1047738,MI,53.0,F,"Massive headache, chills and shivering for hours, body in pain for for a full day and night. Very sore arm Developed large red rash at injection site. Slightly itchy, hot.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,PHM,"Multi. Vitamin, blood pressure medication",None,High blood pressure. Obesity,Moderna 1st shot. Also welt and red rash at injection site,Bactrim,"['Chills', 'Headache', 'Injection site rash', 'Injection site warmth', 'Pain', 'Pain in extremity', 'Rash erythematous', 'Rash pruritic']",2,MODERNA,SYR 1047739,HI,61.0,F,12:00PM 2/13/21 arm muscle pain (hard to lift arm) 10:00 AM 2/14 -16/21 mild headaches and exhaustion 3:30PM 2/19/21 severe lower back pain that went from the lower back (very sensitive to touch)to my toes (toes felt tingly and slightly numb) cannot lie on left side and exhaustion. 9:00AM 2/20 -21/21 could not walk without severe pain from my lower back (sensitive to touch) down my legs to my toes - difficult to walk and cannot lie on left side and exhaustion. 5:00AM 2/22/21 lower back pain that goes down my leg if I put any pressure on my left side and exhausion.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,OTH,Bupropion HCL Latanoprost Eye Drops Multivitamin Calcium D Flame Hyaluronic Acid Alpha Lipoic Acid Body Mint Bright Boost,none,none,,mayonnaise kiawe wood celery corn rodent droppings roach droppings freshly cut grass,"['Back pain', 'Fatigue', 'Gait disturbance', 'Headache', 'Hyperaesthesia', 'Hypoaesthesia', 'Mobility decreased', 'Myalgia', 'Pain', 'Pain in extremity', 'Paraesthesia']",1,MODERNA,IM 1047740,NC,50.0,F,"Pressure/sensation in throat and chest, lightheaded. Was instructed to wait until I felt better, which was 45 minutes later. Given orange juice and attention. Back muscular pain later in day. Headache and chills episode following day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,Synthroid 88 might Loratadine 10 mg Estradiol 0.1 mg patch Caltrate 600 plus Vitamin D (OTC),Bladder prolapse Constipation,Thyroidectomy Partial hysterectomy Polymorphic light eruption,,Penicillin Some sensitivity to latex,"['Back pain', 'Chest discomfort', 'Chills', 'Discomfort', 'Dizziness', 'Headache', 'Oropharyngeal discomfort']",1,MODERNA,SYR 1047741,MN,65.0,F,Extremely severe headache for about 36 hours. Fever 101.5-102 for about 36 hours. Severe body aches stomach cramps.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/18/2021,17.0,OTH,B12...Vitamin D.....Calcium.....Grapeseed.....DHEA.....Spanish Black Radish.....Vitamin C.....Folic Acid,,None,Same as with COVID vaccine. Oct. 2020 Shingles vaccine. First dose. I don?t know brand.,Penicillan,"['Abdominal pain upper', 'Headache', 'Pain', 'Pyrexia']",2,MODERNA,IM 1047742,MA,45.0,F,Rash on arms and legs Applying anti-itch cream,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/20/2021,16.0,PVT,None,None,None,,No,['Rash'],UNK,MODERNA,SYR 1047743,OR,22.0,F,"Nausea, vomiting, chills, fever. Tylenol taken. Nausea, vomiting, and chills lasted from 2 am to 5 am. Fever from 2 am to following day 6 pm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/17/2021,01/18/2021,1.0,UNK,,,,,,"['Chills', 'Nausea', 'Vomiting']",1,MODERNA,SYR 1047744,CA,65.0,M,Severe Vertigo. I have never had vertigo before. Severty decreased over 4 days until gone.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,02/05/2021,7.0,OTH,"atorvostatin, sertraline,",,,,,['Vertigo'],1,MODERNA,IM 1047745,VA,53.0,F,"7 days after vacinne it was itchy and developednres patch by day 8 with tenderness, pain and heat in the 2 inch red oatch at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,02/03/2021,7.0,PUB,"Gabapentin, metroorol","Pneumonia, fibromyalgia, hyoertensiion, sjorens autoimmune diease",Sjorens and fibromyalgia,,"Sulpha, morohine, coedune. Codones, morohones, bee stings","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,SC 1047746,MD,70.0,F,"?COVID Arm? - Vaccine sight area left arm began to itch, slightly tender, became a red blotch 2 x 4 inches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/22/2021,10.0,PHM,Estradiol Patch Vit D3 Garlic Vit C Quercetin Vit A NAC Zinc,None,None,,Slight latex allergy,"['Injection site erythema', 'Injection site pruritus', 'Rash macular', 'Vaccination site pain', 'Vaccination site reaction']",1,MODERNA,IM 1047747,IL,31.0,F,Nausea Dizziness Lightheadedness Dehydration Systolic hypotension Afebrile Syncope without collapse Tachycardia Anxiety Anxiety attack Panic attack Tachypnea Pain upon palpation at site Erythema at site Swelling at site Muscle pain at site that lasted for 3 weeks Weakness that lasted for 7 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,PVT,None,None,None,,None,"['Anxiety', 'Asthenia', 'Dehydration', 'Dizziness', 'Hypotension', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Nausea', 'Panic attack', 'Syncope', 'Tachycardia', 'Tachypnoea']",1,MODERNA,SYR 1047748,MD,63.0,F,Covid arm Swelling redness and rash at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/14/2021,02/22/2021,8.0,PHM,Escitalopram oxalate Rosuvastatin Vit D3 Vit super B complex w folic acid and vit C Tylenol,None,None,,Tetracycline,"['Injection site erythema', 'Injection site rash', 'Injection site swelling']",1,MODERNA,SYR 1047749,VA,47.0,F,"About 20 minutes after vaccination, lips and tip of nose went numb, tongue felt big and fuzzy, strong metallic taste in mouth, felt flushed and HR was elevated. Received 50mg of Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/19/2020,12/19/2020,0.0,PVT,None,None,None,,"Sulfa, Cipro","['Dysgeusia', 'Feeling abnormal', 'Flushing', 'Heart rate increased', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 1047750,CO,52.0,F,Itchy rash around injection site 1st noticed 2/21/21.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/21/2021,9.0,UNK,20 mg Fluoxetine,,,,,['Injection site rash'],1,MODERNA, 1047751,HI,42.0,M,Sleeplessness. Unable to stay asleep for more than 2 hours at a time since receiving first dose of the pfizer covid vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,UNK,N/a,N/a,N/a,,N/a,['Insomnia'],1,PFIZER\BIONTECH,UN 1047752,UT,60.0,F,"A week after the injection I have a 2 inch red, itching, and hot area at the injection site. The first 5 days my arm was painful without redness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/21/2021,6.0,PHM,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth', 'Pain in extremity']",1,MODERNA,UN 1047753,MD,75.0,M,Intermittent chills and continual fatigue began at 10 PM the evening of the second vaccine dose. Chills continued intermittently for about 24 hours and fatigue gradually lessened over 80 hours. Treatment was rest and the occasional acetaminophen tablet.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PUB,"Synthroid, Lipitor, Vitamin D3, Low-Dose aspirin, Saw palmetto",None,hypothyroidism. lipitor is to stabilize plaque,,None,"['Chills', 'Fatigue']",UNK,MODERNA,IM 1047754,CA,68.0,F,Scratchy throat Nausea 2/19 Fatigue body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PVT,,No,Gerd,,PCN Mussels,"['Fatigue', 'Nausea', 'Pain', 'Throat irritation']",2,MODERNA,SYR 1047755,SC,36.0,F,"Body aches, chills, mild fever, extreme muscle soreness. Fatigued. Injection spot bruised with large red, hard and very sensitive to touch circle around it about 1.5-2 inches wide that is hot to touch. Has been there now for almost 4 days with no signs of easing up yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,PUB,"Fluoxetine, phentermine, Allegra, zinc, Advil/tylenol",None,None,,None,"['Chills', 'Fatigue', 'Injection site bruising', 'Injection site erythema', 'Injection site induration', 'Injection site warmth', 'Myalgia', 'Pain']",2,PFIZER\BIONTECH,SYR 1047756,CA,53.0,F,"One week after vaccination my upper arm around injection site started to itch. Over the next 4 days it grew red, swollen, and increasingly itchy. The patch was approximately 5? x 3?. (I took successive photos which I could share.) Then it began to resolve and was better within a week of onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,02/01/2021,7.0,PVT,"Vitamin D; Krill Oil, Occuvite, Buproprion xl, liothyronine, levothyroxine, progesterone, estrogen,",None,"Post Graves? disease hypothyroid, mild asthma",,Bee sting,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 1047757,CA,74.0,F,"Itching and hives-like splotches on left and right sides of arm, below injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/20/2021,0.0,PHM,All purpose vitamin. HRT,None,None,,None,"['Injection site pruritus', 'Injection site urticaria']",2,MODERNA,IM 1047758,NJ,47.0,F,red rash at injection site; itching at injection site; injection site warm to touch; left arm pain radiating from injection site to fingers.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/22/2021,7.0,PHM,Metoprolol ER Succinate 50 mg (1 tablet daily); Norethindrone 5mg (1 tablet daily); Amlodipine Besylate 5 mg (half tablet daily); Rosivastatin 20 mg (1 tablet daily); calcium,None,High blood pressure; obesity (BMI: 32.0); endometropsis,,Sulfa,"['Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site reaction', 'Injection site warmth', 'Pain', 'Pain in extremity', 'Rash erythematous']",1,MODERNA,IM 1047759,WI,65.0,M,"Severe Headache, exhaustion",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PUB,"Lisinopril, Verapamil, Simvastatin",None,High Blood Pressure,,None,"['Fatigue', 'Headache']",1,MODERNA,IM 1047760,KS,47.0,F,"In the 24 hours after the shot I had a sore arm, chills and sweats. A week and a day after the shot, my arm began to itch. I examined the area and found a quarter size rough patch, slightly red. Within 24 hours I had a large(3x3) red, itchy, hot welt in that area. It went away after 2 days, leaving an itchy dry patch on my arm. 2 weeks after the shot, I got a migraine that lasted 3 days and was untouched by tylenol or ibuprofen, along with body aches, nausea, cramps, and diarrhea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/11/2021,8.0,SCH,,,,,,"['Chills', 'Diarrhoea', 'Dry skin', 'Erythema', 'Hyperhidrosis', 'Migraine', 'Muscle spasms', 'Nausea', 'Pain', 'Pain in extremity', 'Pruritus', 'Skin warm', 'Urticaria']",1,MODERNA,IM 1047761,IN,67.0,F,Sore/achy arm at injection site for three days. Extreme tiredness for two days. Body aches for two days. Headache for one day. Chills and fever for one day. Recovered with taking additional baby aspirin for headache.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/12/2021,1.0,PUB,Furosemide 40 mg Potassium CL ER 10 Meq Escitalopram 20 mg Darifenacin ER 15 mg Baby aspirin Biotin Vitamin C Cosamin DS,none,none,,none,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",UNK,MODERNA,SYR 1047762,NY,34.0,M,"Chills, body aches, headache, loss of appetite. 2 days later developed large circle rash around injection site and also pain, large red circle under armpit on pectoral",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,WRK,"Valtrex, vitamins c, d, e, coq10, fish oil, mens multi vitamin, l-cartinene",None,None,,None,"['Chills', 'Decreased appetite', 'Erythema', 'Headache', 'Injection site pain', 'Injection site rash', 'Pain']",2,MODERNA,SYR 1047763,CA,43.0,F,"Very strong post vaccine reaction, severe malaise continuing into third day, HA, sl. Nausea and stomach pain. But worst is inability to lift left arm, severe left arm pain, even joint pain in left wrist. Could barely lift L arm on day 2 after (Sunday) and again unable to lift it day 3 after (Monday). First dose, I had arm pain, trouble lifting it 1 day, pain for a week and mild soreness for the whole month. Pre-existing joint pains from autoimmune were worse for a week, but this second dose - it only seems to be vaccine side, including left jaw, left eye pain, left collarbone pain near a previously affected injury.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,PVT,"Advair, birth control pill, anti-histamine",Mast cell activation syndrome and Histamine Intolerance Ankylosing spondylitis Chronic Lyme disease Asthma,Chronic Lyme disease Ankylosing spondylitis,,,"['Abdominal pain upper', 'Arthralgia', 'Bone pain', 'Eye pain', 'Headache', 'Malaise', 'Mobility decreased', 'Nausea', 'Pain in extremity', 'Pain in jaw']",2,MODERNA,IM 1047764,CO,83.0,F,Patient stated tingling of lips and tongue. I asked her to take an antihistamine if she had one. She stated she had claritin and would send her husband to the store to get benadryl. By the time he got back she was feeling better.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PHM,,,,,,['Paraesthesia oral'],2,MODERNA,IM 1047765,NY,51.0,F,"Swelling at injection site, hard llump under skin, skin at injection site is hot to touch, injection site is painful, injection site is itching and burning",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/22/2021,7.0,PHM,None,None,None,,None,"['Injection site mass', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA, 1047766,TX,33.0,F,Left foot swelling joint and some pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/13/2021,2.0,UNK,No,No,No,,No,"['Pain', 'Peripheral swelling']",1,PFIZER\BIONTECH, 1047767,CA,35.0,F,"at 2am I woke up with fever, chills, headache, and nausea. I took tylenol and it improved. I slept on and off. When I got up the next morning at 6am, I realized I had mastitis on my right breast ( I got the vaccine in my left arm.) The mastitis consisted of redness around the areola, pain, swelling, and my lymph node in my right armpit felt slightly enlarged and painful. My fever was 100.9",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/10/2021,1.0,OTH,Calcium supplement (I am breastfeeding),none,none,,none,"['Breast pain', 'Breast swelling', 'Chills', 'Erythema', 'Headache', 'Lymph node pain', 'Lymphadenopathy', 'Mastitis', 'Nausea', 'Pyrexia']",2,MODERNA,IM 1047768,CA,41.0,F,Round swollen red tender spot at injection site growing in size slightly larger that a quarter,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/13/2021,02/21/2021,8.0,PHM,None,None,,,"Coding, cherry, avocado, pork","['Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,SYR 1047769,CA,57.0,F,"Extreme Abdominal Pain-8 hours, Extreme Arm pain (in the arm that didn't receive the shot)-24 hours, Extreme fatigue-5 days, Chills-8 hours, Fever-3 days (reducing in severity each day), arm pain in shot area- mild and continuous for 6 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/18/2021,2.0,OTH,"Multi-vitamin, Vitamin D with Calcium",none,Obesity,,Erythromycin,"['Abdominal pain', 'Chills', 'Fatigue', 'Injection site pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1047770,OR,50.0,F,"2 days(2/18/2021) Leg pain in both from top of foot to below knee with movement or still . Minor pain along back of legs . (2/20/2021) Pain with step to walk. Only can do 3 or 4 steps. ,(2)21/2021) Get up/Walk with help.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/18/2021,7.0,PVT,Jardiance. Singular. Colace Digoxin. Atorvastatin Oxcarbazepine. Morphine tabs Pantoprazole sodium. Oxycodone Topriramate. Tylenol,"Fibromyalgia, neuropathy, arthritis",Asthma. C pap Oxygen,,"Sulfa, Erythromycin, Gentamicin, More time is running out","['Dysstasia', 'Gait disturbance', 'Pain', 'Pain in extremity']",1,MODERNA,IM 1047771,FL,71.0,M,Next day arm got red and started itching. It?s been doing this for two weeks . I been taking Benadryl.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/09/2021,0.0,PHM,Nothing,None,None,,None,"['Erythema', 'Pruritus']",1,MODERNA, 1047772,NV,52.0,M,"PT DEVELOPED ""HOT SPOTS"" ON BACK OF HIS NECK ON 2/1/21 THAT BECAME BLISTERS AND THEN MORE BLISTERS ON THE LEFT SIDE OF HIS BODY THAT STARTED TO BURN. PT ALSO STATES HIS HEARING ON HIS LEFT SIDE WAS AFFECTED INTERMITANTLY FOR ABOUT A WEEK, AND THE BLISTERS APPEARED NEAR HIS LEFT EYE BEFORE SEEING HIS MD ON 2/11/21 AD BEING DIAGNOSED WITH SHINGLES. PT WAS GIVEN ORAL VALACYCLOVIR PO X7 DAYS, WHICH HE COMPLETED AND PT IS STILL RECOVERING.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,02/01/2021,6.0,OTH,ALBUTEROL PRN AMBIEN PRN,RECENTLY DX ASTHMA,NONE REPORTED,,NUTRASWEET NO OTHER KNOWN DRUG ALLERGIES,"['Blister', 'Burning sensation', 'Herpes zoster', 'Hypoacusis']",2,MODERNA,IM 1047773,IN,27.0,F,Generalized Rash,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,PVT,"Metoprolol, escitalopram, met Forman",None,POTS,,None,['Rash'],2,PFIZER\BIONTECH,IM 1047774,MD,41.0,F,"10 hrs. After shot-Body aches-duration 4days, vomit 1x, chills-12 hours, headache-5 days, 24 hrs. After shot-swollen lymph under left arm- 4 days, 30 hours after shot-swollen teeth and gums on right side of face-5days. NEVER HAD A FEVER",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/11/2021,1.0,PUB,"Sertraline, pravastatin, norgestimate ethical estradiol (birth control)",None,None,,None,"['Chills', 'Gingival swelling', 'Headache', 'Lymphadenopathy', 'Pain', 'Vomiting']",2,MODERNA,IM 1047775,VA,21.0,F,"Pain under the left arm in armpit - suspected swollen lymph node. Tender to the touch, but does not limit daily activity. Noticed around 10:00pm on February 21, EST. Symptoms still occurring 24 hours later.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/21/2021,5.0,OTH,None,None,None,,None,"['Axillary pain', 'Lymph node pain', 'Lymphadenopathy']",1,MODERNA,IM 1047776,CA,43.0,F,"Rash on back, started in the evening, was better by the next day but bumpy eczema type skin remains on back and traveling up back of neck.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/15/2021,3.0,PUB,"Albuterol, Flovent, cetirizine (zyrtec)",,"Asthma, allergies, eczema,",,"Dust, dander, topical skin sensitivity to topical to different chemicals","['Eczema', 'Rash']",UNK,PFIZER\BIONTECH, 1047777,AZ,36.0,F,"Pt received vaccine 2/7/21, awoke 2/8/21 with b/l rash/discoloration of both hands, all fingers, well demaracated just proximal to MCP joints, deepest discoloration left 3rd digit, itching at onset, no blistering, sloughing, pain or swelling. Denies any other complaints. Presented to office (in person)on 2/17/21, rash/discoloration unchanged, itching resolved. neuro exam normal, brisk cap refill, no other rashes, no other systemic complaints. Pt completed blood work and returned to office (via telemed) on 2/22/21 - no change in rash/discoloration appearance.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/08/2021,1.0,PVT,"Ipratropium, Flonase, & Primatene Mist (less than monthly use, none in past 3 months), Sronyx, lexapro 10mg, visatril pamoate 25mg, CBD oil,",None,"Asthma (allergy induced, well controlled), anxiety/depression, patellofemoral pain syndrome",,"no known allergies, other than pollen seasonally","['Activated partial thromboplastin time', 'Antinuclear antibody negative', 'C-reactive protein normal', 'Fibrin D dimer normal', 'Full blood count normal', 'Glomerular filtration rate decreased', 'International normalised ratio normal', 'Neurological examination normal', 'Prothrombin time shortened', 'Pruritus', 'Rash', 'Red blood cell sedimentation rate normal', 'Skin discolouration']",1,MODERNA, 1047778,NM,36.0,F,Injection site was painful to the touch and developed a red rash circle around the injection site with a radius of about 2 inches. It has remained like this for several days. Now as it appears to be going away the injection site feels as though it has caved in slightly and may leave a small scar.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/15/2021,3.0,PHM,Zirtec allergy over the counter One a day vitamin supplement,None,None,,None,"['Injection site indentation', 'Injection site pain', 'Injection site rash', 'Rash erythematous']",1,MODERNA,SYR 1047779,MA,26.0,F,"Got the vaccine on Feb 17, 2021 at 9am. On Feb 18 at around 8:30-9 pm, left cheek started feeling uncomfortable and a bit swollen. The next morning, swelling was extreme and extremely painful to touch. It was difficult to eat from left side and to laugh and talk. Also, had chills and felt weak. I scheduled an online appointment with Dr. he mentioned the condition is called acute pericoronitis and he suggested that vaccine might have increased the immune response to any infection that might have happened underneath the left wisdom teeth which hasn't come out yet. [Note: Same response had happened when I got my MMR vaccine on Feb. 1, 2021]. He prescribed Amoxicillin 500mg for a week. As of Feb 22. 11 pm, after taking Amoxicillin and ibuprofen, the swelling has bit reduced but the pain persists.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/19/2021,2.0,PVT,None,None,None,"Got MMR vaccine on Feb. 1, 2021 at 9 am. I was 26 years of old. The same swelling on left cheek and inflammation of lower left g",None,"['Asthenia', 'Chills', 'Facial discomfort', 'Facial pain', 'Oral discomfort', 'Pericoronitis', 'Swelling face']",1,MODERNA,IM 1047780,MD,36.0,F,"Developed rash along chest, stomach and back about two weeks after first dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,02/10/2021,40.0,PVT,"Prenatal, Vitamin D3",,,,Sulfa,['Rash'],1,MODERNA,SYR 1047782,CA,94.0,M,"SHOULDER INJECTION SITE BECAME VERY SWOLLEN ,BLOTCHY LOOKING, AND HOT TO THE TOUCH",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/19/2021,9.0,OTH,FUROSEMIDE TAMSULOSIN FINASTERIDE CARVEDILOL ATORVASTATIN,NONE,CONGESTIVE HEART FAILURE,,NONE,"['Injection site swelling', 'Injection site warmth', 'Rash macular']",1,MODERNA,IM 1047783,CA,25.0,F,"I received my vaccination on 2/13/21. For a few days, I experienced severe arm pain like experienced for about two days. However starting this weekend on 2/20/21, a week after the vaccine, my arm will occasionally throb and hurt in the same area that I received the injection. The pain and throbbing last for about 10 seconds and appear to occur at random. On a pain scale, I would say it's about a 3 out of 10. After the throbbing, I experience a general sense of discomfort in the area that lasts about an hour or two but that is no longer painful",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,PVT,Levora birth control Pepcid,None,Irritable Bowel Syndrom hidradenitis suppurativa GERD,,Banana Avacado Bactrim,"['Discomfort', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH,SYR 1047784,TX,56.0,F,The doctor offer me some ointment for the cold sore but I am using something so I declined. Told me to take NSAID for bump under my chin. I forgot to tell her about the pain in my left rib area.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/24/2021,23.0,OTH,After the first week I had a cold sore. The second week the left side under my rib cage was sore. The following week I got another cluster of cold sores. A few days later I got a anther cluster of cold sore on the opposite upper lip. T,None,Stroke at 26 years old now 56.,,"Sensitive to antibiotics, each one I have taking over the year has caused me to break out in small skin bump, made my Chest hurt...","['Musculoskeletal chest pain', 'Oral herpes', 'Swelling face']",1,PFIZER\BIONTECH,SYR 1047785,,33.0,F,Tingling sensation throughout vaccinated arm off and on for 24 hours - treated with hot shower and trying to remain still; chronic headache with no prior history of chronic headaches - treated with tylenol,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/21/2021,1.0,SCH,None,None,None,Swelling of lymph nodes after receiving COVID-19 (moderna) vaccine on 01/22/2021; patient age: 33,Amoxicillin,"['Headache', 'Paraesthesia']",2,MODERNA,SYR 1047786,,22.0,M,"HA following #2 Moderna vaccine on 16FEB2021. Had fever, bodyache and arm pain which went away. Took 2tabs of 325mg tylenol which is not helpful.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/18/2021,2.0,MIL,UNK,,,,Denies,"['Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 1047787,CA,48.0,F,"Day 1 - fever of 102, body aches, headache, could barely move Rt. arm, tight chest, little appetite. Day 2 - temp down to 100, body aches more mild, still a headache, pain near groin lymph nodes, arm more mobile but now with a red hot and painful lesion",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2020,02/21/2020,1.0,PHM,"Gabapentin, Propanolol , Motrin",None,Asthma,,"Bees, latex, monastat , mangos,","['Chest discomfort', 'Decreased appetite', 'Erythema', 'Headache', 'Lymph node pain', 'Mobility decreased', 'Pain', 'Pyrexia', 'Skin warm', 'Wound complication']",UNK,MODERNA, 1047788,,49.0,M,Chills and bodyache following #2 of moderna yesterday.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/18/2021,1.0,MIL,UNK,,,,Denies,"['Chills', 'Pain']",2,MODERNA,IM 1047789,OR,30.0,M,-Fever/chills -extreme body ache -bones hurt,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/20/2021,3.0,OTH,-vitamin c -zinc,,,,-tylenol -mangos,"['Bone pain', 'Chills', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,SYR 1047790,TN,27.0,F,Climbing Fever starting around 9:00 pm with current temp of 102.2 as of 10:50 pm (body temperature usually <97). Severe chills onset around 9:30 pm. Mild Soreness at injection site starting approximately two hours after vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,OTH,Levothyroxine,None,Mild idiopathic Hypothyroidism ( controlled),,Penicillins,"['Body temperature increased', 'Chills', 'Injection site pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1047791,WI,70.0,F,"Beginning about 3;00 pm the day of the injection (8:16 am), soreness at injection site,. Beginning about 5:00 pm, severe headache, chills, fever (101.5), teeth hurt, arm was very tender, lethargy. The next day, the headache, chills (but less intense), and extreme lethargy continued. Symptoms started to subside late in the day. By the next morning, only mild headache remained and subsided as the day went on. Arm soreness continued throughout the day into the evening.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,"10 mg simvastatin, 37.5-25 mg Triamerene-HCTZ, 20 mg Telmisartan, 0.375 mg Hyoscyamine, Multivitamin Women 50+ OTC",none,none,,none,"['Chills', 'Headache', 'Injection site pain', 'Lethargy', 'Pyrexia', 'Tenderness', 'Toothache']",UNK,MODERNA,SYR 1047792,OH,76.0,M,Constipation 5 days still going,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,PUB,,,,,,['Constipation'],1,PFIZER\BIONTECH,IM 1047793,CA,47.0,F,"Developed itchiness on face and mild palpitation 20 minutes after injection Developed headache and injection site soreness 12 hours after injection Developed dizziness about 20 hours after injection Developed itchiness, redness, and welt below the injection site 3 days after injection and lasted for about 5-7 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,PVT,none,"GERD, PCOS, Seasonal allergies","GERD, PCOS",Headache and arm soreness 12 hours after injection. took excedrin,"morphine,vicodin, bacitracin","['Dizziness', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Palpitations', 'Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,IM 1048786,KS,87.0,M,"Was given vaccine around 1:30Pm on 2-11-2021. He and his wife waited in the building for 15 minutes and then left. he denied complaint. (He was waiting to have both Covid shots before he went to cardiologist Re: CAD.) He had an alarm going off in his house, was going to basement to check it out. Police officer heard alarm, came into house, & heard a thud when Doc fell. He was in PEA (Pulseless Electrical Activity) when brought into ER. Given 5 ""rounds of Epinephrine with no response.",Yes,02/12/2021,Yes,Not Reported,,Not Reported,N,02/11/2021,02/12/2021,1.0,PUB,unknown,"? sepsis, CAD, HTN, increased lipids","hypertension, constipation, hyperlipidemia, CAD, BPH",,"Orudis, Statins (intolerance)","['Cardiac arrest', 'Electrocardiogram', 'Fall', 'Full blood count', 'Metabolic function test', 'Pulseless electrical activity', 'Unresponsive to stimuli']",1,MODERNA,IM 1047794,CA,40.0,F,Large red rash similar to COVID arm side effect appeared at the injection site. This was almost a week later.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/19/2021,6.0,PUB,"Loratidine, birth control pill- Portia",None,None,Lymphadenopathy with tetanus booster dose,None,"['Injection site erythema', 'Injection site rash']",1,PFIZER\BIONTECH,IM 1047795,TX,45.0,F,"Purple mark around injection site . Directly below the site, there is a large red patch that is swollen and warm to the touch. I had a red patch and swelling after the first dose also. That one is now a faint purple. Same arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,OTH,None,None,Asthma,Moderna Covid vaccine dose 1 on 01/22/2021.,Sulfa,"['Injection site discolouration', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth']",2,MODERNA,SYR 1047796,AL,44.0,M,Started itching of mouth face and upper body within 10 minutes of injection. Became dizzy with tunnel vision. Went to urgent care had elevated blood pressure of 178/110. Receive steroid injection and prescription for hydroxyzine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,OTH,Metformin,,,,"Penicillin, nuts","['Blood pressure increased', 'Dizziness', 'Oral pruritus', 'Pruritus', 'Tunnel vision']",1,PFIZER\BIONTECH,IM 1047797,CA,68.0,M,Symptoms started within 3 days of getting the shot. As per Hospital : severe UTI - cleared up completely severe Pancreatitis - cleared up completely Severe diabetes - placed on high insulin severe kidney failure - placed on dialysis,Not Reported,,Yes,Yes,10.0,Yes,N,01/29/2021,01/29/2021,0.0,UNK,lisinopril glipizide clonidine hydrochlorothiazide levothyroxine multi vitamin saw palmetto magnesium Niacinamide cod liver oil metformin,NONE,Pre Diabetes,Flu shot - caused the one and only time in my life I had the,NONE,"['Blood insulin', 'Diabetes mellitus', 'Dialysis', 'Pancreatitis', 'Renal failure', 'Urinary tract infection']",1,MODERNA,SYR 1047798,TX,22.0,M,"Immediate soar arm, next day horrible body/joint/head aches, intermittent fever up to 103.4 degrees F, mind fog, severe malaise and fatigue, chills. All those lasted about 4 days. They really bad ?COVID toes? that were like chlybains and now 3 weeks later look like petechiae on top of toes (reddish - purple , a few are bleeding). By the way I had Mono 13 months ago that was pretty bad and had COVID in November not that severe at all.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,PHM,"Adderal, fanasteride",Mild symptoms from first dose of moderna COVID vaccine on 01/05/2021,None,,None known,"['Arthralgia', 'COVID-19', 'Chillblains', 'Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Infectious mononucleosis', 'Limb discomfort', 'Macule', 'Malaise', 'Pain', 'Petechiae', 'Pyrexia', 'Skin haemorrhage', 'Vaccination complication']",2,MODERNA,IM 1047799,CO,34.0,F,Numbness and tingling of face and lips that got progressively worse. Throat swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,PVT,Levothyroxine 150 mcg,None,None,,None,"['Hypoaesthesia', 'Hypoaesthesia oral', 'Paraesthesia', 'Paraesthesia oral', 'Pharyngeal swelling']",1,PFIZER\BIONTECH,IM 1047800,IL,48.0,F,"Sore arm on days 1,2,3. On day 5 I noticed a scab or almost lesion where the shot was given Today on day 6 I am achy on my left side only. Mostly my neck, arm and also my left side thigh.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/21/2021,4.0,PVT,,,,,,"['Injection site pain', 'Injection site scab', 'Pain in extremity']",1,MODERNA, 1047801,RI,68.0,F,"I had the virus in August of 2020 for 30 days until symptom free. ON 2/6/2021 received first vaccine injection. within 3 minutes a light headache started. That evening, rash and itching on right fore-arm and under chin. took benedryl. Woke at 3:30 am on 2/7 not feeling well and left arm very sore and could not touch. 6:30 am - chills with severe body shaking and 101 temp. 7:30 am 102.2 took tylenot 8 hr 650 mg. Oxygen at 96, heart rate at 76 and BP 117/68. 8:00 am 101.9 temp. 10 am 100.6 temp. 1:30 pm 102.9 temp. 2:00 pm 103.3 Took Tylenol, extra strength 2 tabs. 8:30 pm used inhaler due to chest pains 101.3 temp. took benedryl. Oxygennn @98 HR-82 BP 145/77. 11.00 pm 103.3 temp. took 2 tylenol. Mon 8:00 Monday am continued/ 100.2 temp oxygen 97 HR-70; 99.2 temp BP 110/71. 7 pm. took Benedryl for congestion. Quit taking stats. Fatigue and rest took play at this point. Since then have had intermittent low grade fever in 99.2 to 99.9. Same with headache and extreme fatigue. Have high risk husband that I take care of . He had his first vaccine at same time. No side effect at all. I am scheduled for 2nd vaccine on March 6th. I am very apprehensive about taking it with this reaction. Please advise/recommend if I should proceed. My PCP stated that these reactions were evidence the vaccine is working. Is this because I had the virus??? Both the virus and vaccine have been really hard on me. I am usually a very active person and since August, I have been struggling with fatigue. First time in life. Thank you.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/06/2021,02/06/2021,0.0,OTH,None - withheld in preparation of vaccination.,"allergies, seasonal and chronic sinus issues","Bradycardia, Asthma, sinus issues and vascular disease.",,"Pencillin, vicodin, Codeine,Keflex, Carafate, E-mycin, Aspirin:sensitivity, Neo Sporin Ointment. Predisposed to Morphine so do not take. Allergies to foods and environment. Anti-philatelic experiences with medicine, food and environment.","['Chest pain', 'Chills', 'Fatigue', 'Headache', 'Pain in extremity', 'Pyrexia', 'Rash', 'Tremor']",1,MODERNA,IM 1047802,CA,76.0,F,"Slight fever, loss of strength, headache, extreme difficulty breathing. Oxygen, steriods, antibiotics for UTI, Cyanotic according to EMS and saturating at 80s at home. No accute pathology but hyperinflated WBC was 19. Sent home with oxygen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/18/2021,2.0,PVT,"Amlodipine Besylate 5mg, hydrochlorothaizide 12.5mg, bupropion XL 150 mg, atorvastatin 20mg, escitalopram 10mg, Stiolto 2.5/2/5 MG INH 4GM MFG, B complex, multivitamin, calcium chews +D & K, D3.",UTI,COPD,,NO,"['Asthenia', 'Blood potassium decreased', 'Blood test', 'Cyanosis', 'Dyspnoea', 'Echocardiogram', 'Headache', 'Oxygen saturation decreased', 'Pyrexia', 'Ventilation/perfusion scan', 'White blood cell count increased']",2,MODERNA,IM 1047803,CA,62.0,F,Soreness at injection site and fatigue within several hours; headache next morning with slight dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,OTH,Low dose aspirin,None,Coiled brain aneurysm,,None,"['Dizziness', 'Fatigue', 'Headache', 'Injection site pain']",1,PFIZER\BIONTECH,IM 1047804,TX,43.0,M,"The immediate 48 hours after the second dose was not a problem. It was around 72 hours in which acute muscle soreness occurred at the injection site on my right deltoid. I thought it would resolve like the first dose after three or four days, but this seem to last longer and then it mysteriously begin to travel down my arm. It seems like every one or two days it went more distal down my right upper extremity. It first went from my deltoid to my bicep and tricep. And then a couple days later it was in my elbow and forearm. Now it has been in my elbow for weeks leaving me with weakness and pain that nothing seems to help improve it. It?s like it is in my joint at my right elbow. There is a very specific soreness and pain which has cost me a significant discomfort and weekend my strength and the entire arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/21/2021,11.0,PVT,,None,None,,None,"['Injection site discomfort', 'Injection site joint pain', 'Injection site muscle weakness', 'Injection site pain']",UNK,PFIZER\BIONTECH, 1047805,CO,67.0,F,Rash with raised bumps. No itch however if I scratch them they bleed.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,OTH,"Fioricet, hydralazine, hydroxyzine,baby aspirin, clonazepam,synthroid, gabapentin, ranitidine Tylenol, Valium,repatha, albuterol, astalin, b12,D3, botox","Mast cell, asthma, hashimoto's, migraines,","Arthritis, chronic pain, asthma, Mast cell, diverticular disease, myofascial, osteoarthritis, allergies, cardiovascular disease,pots, hashimoto's, hemiplegic migraines,",flu vaccine,"Allergic to many things. I have mast cell.laytex, many foods, many antibiotics, smells, dyes,",['Rash papular'],UNK,PFIZER\BIONTECH,SYR 1047806,ID,43.0,F,"Intense joint pain in hips and pelvis, especially left side. Pain progressed throughout the day making it difficult to move.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/22/2021,2.0,PVT,none,none,none,,none,"['Arthralgia', 'Pelvic pain']",2,MODERNA,SYR 1047807,AL,68.0,F,"After some eight hours after the injection patient's glucose level dropped to a unsafe level. (48) After eating dinner, some three hours later, patient took Jardiance 25mg. and one Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PVT,,,,,,"['Blood glucose', 'Blood glucose decreased']",1,PFIZER\BIONTECH,SYR 1047808,MI,54.0,F,"First as expected arm sore apx 5 hrs post, at 930 pm extreme upper abdominal pain (similar to pancreatitis), followed by continuous nausea, vomiting for 1.5 days eased finallyby Zofran. On day 2 my lips began to swell and were itchy, by day 3 they were very swollen, took benadryl every 8 hrs and by day 5 today they are fairly normal but still sore. My arm also swelled and spread to arm pit and was very hot and red. The redness has mostly gone, the swelling has lessened but not gone. Still sore and itchy. Still pretty run down and no energy. My cousin and I live together and were vaccinated at the same time and both had these symptoms except the lips swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,PVT,"Benadryl, creon, ibuprofen, acetaminophen, escitalipram, pantoprozole, d3, probiotics, atorvastatin, 87 m aspirin","Chronic pancreatitis, low igg, 21 months post lad heart attack and heart aneurysm","Chronic pancreatitis, low igg, 21 months post lad heart attack and heart aneurysm",,"Morphine, eggs, wheat, coffee, dairy, corn, seasonal, pet dander, grass.","['Abdominal pain upper', 'Asthenia', 'Erythema', 'Lip pruritus', 'Lip swelling', 'Nausea', 'Oedema peripheral', 'Pain in extremity', 'Peripheral swelling', 'Skin warm', 'Vomiting']",2,MODERNA,IM 1047809,,30.0,M,"CHIEF COMPLAINT & HPI: Pt presents to ED for fever after COVID-19 vaccination. Pt received 2nd dose of COVID-19 vaccination yesterday then reports feeling fever and fatigue 12 hours later. No rash, shortness of breath, or chest pain. Pt symptoms were controlled with acetaminophen that he took at 0700 this AM. Pt was sent to the ED by his chain of command in order to be tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/29/2021,1.0,MIL,UNK,,,,NICKEL,"['Fatigue', 'Pyrexia']",2,MODERNA,IM 1047810,,20.0,F,CHIEF COMPLAINT & HPI: 20 yo F here with sore throat after her 2nd covid vaccine. no fever/chills. no NVD. no cp/sob. No difficulty breathing.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/29/2021,2.0,MIL,UNK,,,,,['Oropharyngeal pain'],2,MODERNA,IM 1047811,,49.0,M,CHIEF COMPLAINT & HPI: 49 yo M here with body aches and chills after his 2nd covid vaccine yesterday. no fever. no cp/sob. no nvd. Pt able to eat and drink normally.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/29/2021,1.0,MIL,UNK,,,,,"['Chills', 'Pain']",2,MODERNA,IM 1047812,CA,67.0,F,After three days my injection site started swelling and itching Now it's gotten worse and it's been 7 days. I have a hot red swollen patch about the size of a half dollar that itches.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/18/2021,3.0,OTH,None,None,None,,None known,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 1047813,,40.0,F,CHIEF COMPLAINT & HPI: 40 yo F had her covid vaccine #2 yesterday and has been having fever/chills/body aches/nausea. No CP/SOB. no difficulty breathing.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/29/2021,1.0,MIL,UNK,,,,"Reglan, METOCLOPRAMIDE HCL","['Chills', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,IM 1047814,AK,70.0,F,"Lightheaded, headache, upset stomach, sore arm , within 30 minutes post vaccine. tired. Poor sleep quality at night after vaccine. Chills, Fever and scratchy dry throat began about 10 hours post vaccine. Fever of 100.4 lasted about 18 hours. Loose stools after about 24 hours. Ear ache and tender neck lymph nodes began after 24 hours. dry throat lasted 48 to 72 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PHM,None,None,None,Sore arm,None,"['Abdominal discomfort', 'Dizziness', 'Dry throat', 'Ear pain', 'Fatigue', 'Feeling cold', 'Headache', 'Lymph node pain', 'Pain in extremity', 'Poor quality sleep', 'Pyrexia', 'Throat irritation']",UNK,MODERNA, 1047815,,31.0,M,"patient reports muscle aches, chills, nausea, fatigue headache that started last night. states recieved COVID vaccine yesterday.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/28/2021,1.0,MIL,UNK,,,,NKDA,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea']",1,MODERNA,IM 1047816,,22.0,M,"22 yo M w/ no known chronic medical conditions, got COVAX in L delt 1 week ago, now w/ raised/erythematous/itchy rash overlying L delt that started last night. The story sounds c/w localized vaccine reaction, but the area is indurated/warm, so just in case of cellulitis I plan to treat w/ keflex. I do think there is an inflammatory/allergic component, so I also prescribed topical hydrocortisone for itching. Discussed plan/SRP w/ pt in detail. Answered all questions. Pt verbalized understanding, agreed to plan/SRP, and pt was d/c'ed in stable condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/20/2021,7.0,MIL,UNK,,,,NKDA,"['Induration', 'Rash erythematous', 'Rash papular', 'Rash pruritic', 'Skin warm']",1,MODERNA,IM 1047817,,21.0,M,"21 yo M w/ no known chronic medical conditions, presents w/ 2 hours MEG/central chest burning. Initial a/w mild SOB and LH; by time of my eval, LH/SOB had resolved and CP was 4/10. Pts sx completely resolved w/ GI cocktail. No exertional sx. No recent infectious sx.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,02/01/2021,3.0,MIL,UNK,,,,NKDA,"['Chest pain', 'Dyspnoea']",2,MODERNA,IM 1047818,CA,54.0,F,"54 y o female c/o hives to face _ none seen) , lip tingling and 5/10 chest pain Given 50 mg of Benadryl IM right deltoid at 204 pm and placed on 10 lpm O2 via mask at 205 pm O2 reduced to 8 lpm via mask after 2/10 chest pain Lungs CTA bilaterally non-labored breathing. Client had used albuterol PTA Client on room air at 234 pm and feeling good. Denies any lip tingling Chest pain resolved. VSS 102/78 70 24 Client agreed to follow up with PCP prior to 2nd CoVid vaccine. Meds: Zyrtex, albuterol, Advair, Flonase, singular Allergies: morphine, lidocaine, EES Client DC;d home stable NAD MAEW non-labored breathing",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PUB,"Meds: Zyrtex, albuterol, Advair, Flonase, singular",none,respiratory,,"Allergies: morphine, lidocaine, EES","['Chest pain', 'Paraesthesia oral']",1,MODERNA, 1047819,CA,76.0,F,"2/02/2021 developed shingles ( herpes roster) first time in my life. Severe pain, red bumps on right back and front",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,02/02/2021,19.0,PUB,"glaucoma eye drops, amlodipine, vitamins D & C",none,"glaucoma, high blood pressure",,,"['Herpes zoster', 'Pain', 'Rash erythematous']",UNK,MODERNA, 1047820,OR,37.0,M,"37yo male with no cardiac risk factors had spontaneous dissection of rt coronary artery 5 days post vaccination w associated MI requiring 3 drug eluting stents and ""extreme"" clot burden on cath requiring tPA.",Not Reported,,Yes,Yes,5.0,Not Reported,N,01/07/2021,01/12/2021,5.0,PVT,,,none,,,"['Catheterisation cardiac abnormal', 'Coronary artery dissection', 'Myocardial infarction', 'Stent placement', 'Troponin increased', 'Ventricular extrasystoles']",1,PFIZER\BIONTECH,IM 1047821,NY,33.0,F,Body aches and chills the following morning after receiving the vaccination. I was very sluggish and remained in bed for the majority of the day. I also had a lot of pain at the injection site and couldn't lift my arm. Tylenol resolved the issues for the most part but it was only effective for about three hours prompting me to wait an additional 2-3 hours with the symptoms. This lasted 24 hours and I felt good as new the following day with minor pain at the injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PVT,None,None,,,None,"['Chills', 'Injected limb mobility decreased', 'Injection site pain', 'Pain', 'Sluggishness']",UNK,MODERNA,IM 1047822,CA,49.0,F,Severe bodyaches headache fever of 102.4 chills and two days after receiving the injection broke out in hives,Not Reported,,Yes,Not Reported,,Not Reported,Y,02/11/2021,02/12/2021,1.0,PVT,Adderall 20 mg three times a day,No,No,,Penicillin amoxicillin ampicillin,"['Chills', 'Headache', 'Pain', 'Pyrexia', 'Urticaria']",2,MODERNA,SYR 1047823,NM,19.0,F,"Localized super infection occurred 11 days after first receiving vaccine. Diagnosed with asthma soon after and hospitalized for the first time on 2/13 for severe respiratory complications. Prescribed nebulizer treatment at home with albuteral, montekulast, prednisone, and qvar inhaler. Went to urgent care today in hopes to avoid hospital bills. Chest xray showed some fluid. Prescribed iputropium for my nebulizer treatment and also azithromyacin to stall any infection. Lets hope no more hospital visits. Waiting to hear back from pulmonologist to schedule appt.",Not Reported,,Not Reported,Yes,2.0,Yes,N,01/13/2021,01/22/2021,9.0,PHM,BuproprionXL and Sertaline,,None until this :/,,Penecilin,"['Asthma', 'Breath sounds abnormal', 'Chest X-ray', 'Chest X-ray abnormal', 'Localised infection', 'Pleural effusion', 'Respiratory disorder', 'Superinfection']",1,MODERNA,IM 1047824,IA,20.0,F,"After first dose, got hives around injection site on left arm about 12 days later. Went away over night, but reappeared briefly a couple days later. After second dose, got same hives around injection site a couple days after vaccination. Comes and goes. On 2/22 got hives on left and right arms, back, and chest.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/23/2021,6.0,UNK,,,,,sulfa (hives),"['Injection site urticaria', 'Urticaria']",2,MODERNA,IM 1047825,CT,70.0,F,"Rash at the injection site, COVID arm, appearing one week after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/22/2021,7.0,OTH,None,None,High cholesterol,,None,['Injection site rash'],1,MODERNA,IM 1047826,NV,27.0,F,"Approximately 12 days post vaccination, vaccination spot became swollen, red, and firm, slightly bothersome and itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/22/2021,8.0,WRK,"Sertraline, buspirone, lisnopril",None,High blood pressure,,None,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 1047827,OR,41.0,F,Left arm/shoulder. Large red itchy rash at injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/22/2021,2.0,OTH,None,None,None,,Latex,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash']",2,MODERNA,SYR 1047828,MD,41.0,M,"Nausea, vomiting, cramping, fever, chills, lethargy, headaches, and body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,PVT,Paxil 30 mg Astorovstatin 40 mg Lisinopril 10 mg Multivitamin and vitamin b supplement,None,Obesity High blood pressure High cholesterol,,Tahini Oil,"['Chills', 'Headache', 'Lethargy', 'Muscle spasms', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,SYR 1047829,CA,50.0,F,"I developed a left arm DVT just over a week after the vaccination, same arm as the injection. It manifested as a thick painful cord protruding out of my left armpit and down my inner arm. I was initially misdiagnosed with tendonitis. I sought a second opinion, and a venous ultrasound was completed on that arm. I immediately went to the ER after the ultrasound found the blood clot. Luckily, it hadn't progressed to a pulmonary embolism. The blood thinner I'm taking (Xarelto starter pack) for the clot seems to be working since the thick painful cord is going away.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/16/2021,9.0,PVT,"Metformin 500mg (twice a day), Vitamin D 2000 IU (every day or when remembered), Vitamin B12 500mcg (twice a week)",None,pre-diabetes,,None,"['Computerised tomogram', 'Deep vein thrombosis', 'Ultrasound scan']",1,MODERNA,IM 1047830,OR,35.0,F,"Mild fever (no higher than 99.5F), fatigue, muscle aches, injection site pain all started about 15 hours after vaccination and lasted about 12 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,UNK,None,None,None,,None,"['Fatigue', 'Injection site pain', 'Myalgia', 'Temperature intolerance']",1,MODERNA,IM 1047831,WA,65.0,F,"acute flu lasting 3 days followed by 1 day with lighter symptoms. The 3 days included acute pain,fatigues,sleepiness,chills, body aches . On day 2 about 28 hours after taking the vaccine I walked to the bathroom and fainted. I am 65 and have never fainted.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/05/2021,1.0,PVT,,DIABETE HEART DISEASE,diabetes heart disease,new hepatis vaccine give in the early 80's,,"['Chills', 'Fatigue', 'Influenza', 'Pain', 'Somnolence', 'Syncope']",2,MODERNA,SYR 1047832,VA,60.0,F,Round rash the size of a 50 cents coin. Itchy and red. The area turns white when I lift my arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/22/2021,2.0,MIL,"High blood pressure medicine Vitamin supplements D3, B12, B-complex, Multi vitamin, C, garlic",Sinus allergy,"Arthritis, inflammation",,Cymbalta Topomax Velocous antibiotic,"['Pallor', 'Rash', 'Rash erythematous', 'Rash pruritic']",2,PFIZER\BIONTECH,SYR 1047833,VA,42.0,F,"Within 3-5 days of receiving first vaccine, I developed lymphadenopathy in the axillary of the arm used for injection. I then also began to notice that my (previously diagnosed, treated, and under control) eczema began to manifest. It has persisted and is only marginally under control with previous prescription steroid ointment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/13/2021,3.0,PVT,Lexapro 20mg Lamictal 100mg Seroquel 50mg,none,Excema,,Milk,"['Condition aggravated', 'Lymphadenopathy']",1,MODERNA,IM 1047924,WI,37.0,F,Severe deep throbbing headache that Tylenol did not work on. Lasted 8 hrs caused nausea and eye pressure.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,OTH,"Eliquis, Biotin, ferrous sulfate",low iron,"asthma and history of DVT, PE and PVT",Flu shot age 33 injection site swelling and burring lasting 1 week. Later finding out allergic to eggs.,"Shellfish, eggs","['Eye pain', 'Headache', 'Nausea']",1,MODERNA,IM 1047925,TX,78.0,F,"At location, she felt fine during 15min wait At 3:30-4:30 Zoom call, she looked good, but said she wasn?t feeling great & was concerned due to chills & 4days headaches after 1st dose At 8:30pm she called with chills, 3 layers of clothes & bedwarmer on... said her teeth chattered & was trying to drink warm water to heat from the inside (hydration w/o cold water; said no more coffee) At 11:00pm she texted chills were over, she was expecting aches ?but would be asleep during them?... good attitude at the time At 2:19am she called, had fallen & couldn?t get up, said she called a friend to come help her ... said she?d tried to get up, but legs were numb... said she was dizzy when she fell, total dry mouth & had reached for water, but it spilled when she knocked into things when she fell. She wondered if she should call Fire Dept (but wasn?t making total sense). Her friend came, tried to help, but I think she decided to call 911 for help getting her up & wants EMTs to check her out. **She had fallen during Covid, went to ER & they gave fluids & she was ?good? for a week, but then dizzy & severe lethargy, same friend took her to ER & she was admitted (negative covid test at that point), but very large PE, thus heparin & then Eliquis (Dec 2020).",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/23/2021,1.0,OTH,"Eliquis due to Covid Pulmonary Embolisms + many others (I?m daughter ... Mom got dizzy, fell & couldn?t get up, said legs felt numb & her friend is calling 911 to help now)",Eliquis after heparin in ICU for Covid PE in December 2020,"hbp, non-obese weight, cholesterol","1st dose Covid vaccine: chills, aches, 4days headache","Morphine, codeine-based","['Chills', 'Dizziness', 'Dry mouth', 'Fall', 'Headache', 'Hypoaesthesia', 'Lethargy', 'Pain', 'Pulmonary embolism']",2,PFIZER\BIONTECH,SYR 1047926,,,U,"An hour after shot I began experiencing numbness, tingling, dizziness, and redness on the left side of my face in the cheek area. I took ibuprofen and with the advice if an online doctor I went to ER 5 dsys after the shot to have CT scan.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Blood test', 'Computerised tomogram', 'Dizziness', 'Electrocardiogram normal', 'Erythema', 'Hypoaesthesia', 'Paraesthesia']",1,MODERNA, 1048191,MA,,F,"It leaked and she is concerned she missed some of the dose; A spontaneous report was received from a nurse concerning a 36-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and it leaked and she is concerned that she missed some of the dose. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection, but there was an issue with the needle and syringe. It leaked and she is concerned that she missed some of the dose. Treatment information was not provided. The outcome of the even was considered resolved on 05 Feb 2021.; Reporter's Comments: Based on current information the causality of this event was assessed as not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Incorrect dose administered'],1,MODERNA,OT 1048192,FL,65.0,M,"the injection went too low on his deltoid; got a bruise, a fairly good size of bruise; A spontaneous report was received from a healthcare professional concerning a 65-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fairly good size of bruise. The medical history was not provided. Concomitant product use was not provided. On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 07 Jan 2021, the injection went too low on his deltoid, and he suspected that it did not hit the deltoid muscle but the muscle below that, and that was why he got a bruise. He got a fairly good size of bruise. He also stated that he didn't have a lot of muscle mass. On 04 Feb 2021, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection and he had no issue. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event vaccine administered at inappropriate site was considered resolved on 07 Jan 2021. The outcome of the event fairly good size of bruise was unknown.; Reporter's Comments: This report refers to a case of vaccine administered at inappropriate site for mRNA-1273 (lot # unknown) with reported non-serious unlisted event of contusion. Based on the current available information and temporal association between the use of the product and the start date of the event of contusion, a causal relationship cannot be excluded",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Contusion', 'Product administered at inappropriate site']",1,MODERNA,OT 1048193,MI,90.0,F,"Hallucinating, seeing things; Was in overdrive; Couldn't sleep, she was awake for 24 hours; A spontaneous report was received from a consumer calling in regards to her 90 year old mother who ""started hallucinating, seeing things, she was talking to people who weren't there"". ""She was awake for 24 hours"", ""she was in overdrive"". The patient's medical history included, Dementia, High blood pressure and Low blood pressure. On 05-Feb-2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 vaccine, Lot # 038K20A, intramuscularly into her left upper arm for prophylaxis of Covid-19 infection. On the night of 06-Feb-2021, the patient started hallucinating, ""She was seeing things"", ""she was talking to people who weren't there"". She ""couldn't sleep, she was awake for 24 hours. ""She was in overdrive"". She was reaching for things that weren't there,""hearing babies crying"", ""people knocking at the door"", "" stay couldn't stay still, she was arranging things"". ""Things that didn't bother her before were now a big problem"". She was , ""out of her mind"". The reporter further stated, she was stronger, ""didn't need her walker anymore"". Finally yesterday (07-Feb-2021) she slept for 24 hours straight. She stated her mother is now back to her ""dementia"" self. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the events, Hallucinating, seeing things,talking to people who weren't there, Couldn't sleep, Awake for 24 hours, in overdrive, reaching for things that weren't there, hearing babies crying, people knocking at the door, couldn't stay still, arranging things. Things that didn't bother her before were now a big problem, out of her mind. stronger, didn't need her walker anymore"", were considered recovered/resolved. Company comment: the reported events Hallucinations, Abnormal Behavior, and Sleep disorder"" were considered possibly related to mRNA-1273.; Reporter's Comments: This report concerns a 90--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # 038K2A and started hallucinating, seeing things, she was talking to people who weren't there"". ""She was awake for 24 hours"", ""she was in overdrive"". Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,UNK,CARVEDILOL; DONEPEZIL; LEVOTHYROXINE; LOSARTAN; Methotrexate; OMEPRAZOLE; PAROXETINE; PREDNISONE; SIMVASTATIN; CALCIUM; FISH OIL; MEMANTINE,,Medical History/Concurrent Conditions: Dementia; Hypertension; Hypotension,,,"['Abnormal behaviour', 'Hallucination', 'Sleep disorder']",1,MODERNA,OT 1048194,MA,59.0,M,"Cellulitis infection; Right ankle pain; Body pain; Joint pain; A spontaneous report was received from healthcare professional concerning a 59-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis infection, joint pain and right ankle pain, and body pain. The patient's medical history included hypertension, cirrhosis of the liver, splenomegaly, sarcoidosis of the lung, diabetes, and having varicose veins in the stomach. No relevant concomitant medications were reported. On 22 Dec 2020, the patient received his first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the right upper arm. On 19-Jan-2021, prior to the onset of the events, the patient received his second of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in the left upper arm for prophylaxis of Covid-19 infection. On 22 Jan 2021, the patient experienced a joint pain and body pain. On 25 Jan 2021, the patient experienced right ankle pain. On 28 Jan 2021, the patient experienced a severe cellulitis infection in his arm and was hospitalized from 28 Jan 2021. The patient was discharged from hospital on 08 Jan 2021. Treatment for the events included Cetaphil (reported as IV) and cephalexin (antibiotic). Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events joint pain and body pain were resolved on 25 Jan 2021. The outcome of the event right ankle pain was resolved on 28 Jan 2021. The outcome for the event of cellulitis infection was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,12.0,Not Reported,Y,12/22/2020,01/22/2021,31.0,UNK,,Cirrhosis of liver; Diabetes (Diabetes pump); Gastric varices; Hypertension; Pulmonary sarcoidosis; Splenomegaly,,,,"['Arthralgia', 'Cellulitis', 'Pain']",1,MODERNA,OT 1048195,CO,,M,"Seizures; Seizure; A spontaneous report was received from a physician assistant concerning a patient of unknown age who experienced seizures. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 11JAN2021, approximately 16 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 26JAN2021 and 29JAN2021, the patient experienced seizures. The patient does not have history of seizures. The patient was transported to the ER for treatment and they had a consult with a neurologist on 08FEB2021. The neurologist advised the patient that it would be ok to get the second dose of the vaccine. The events seizures, was considered resolved on 26 Jan 2021 and 29 Jan 2021.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of seizure (twice) after receiving first dose of mRNA-1273 (Lot# unknown). Very limited information has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/26/2021,15.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No Reported Medical History),,,['Seizure'],1,MODERNA,OT 1048196,FL,48.0,F,"Passed out/ Status post syncopal episode; Double vision; Diagnosis of static vision; Hypothyroid; Diarrhea; Injection site pain; Headache; A spontaneous report was received from a healthcare professional concerning a 48-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypothyroidism, passed out/status post syncopal episode, diarrhea, injection site pain, headache, static vision/double vision. The patient's medical history was not provided. Concomitant medication history was not provided. The patient received their first of two planned doses of mRNA-1273 (batch number: unknown) on 24 DEC 2020. On 21 JAN 2021, the patient received their second of two planned doses of mRNA-1273 (batch number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. The patient developed injection site pain and diarrhea after the second dose. She continued to have the headache from the first dose that was administered. On 03 FEB 2021, the patient experienced double vision and dizziness while driving to work. The patient passed out at work and was admitted to the hospital. A CT of the brain showed no acute findings and her CT angiography was normal. The patient was discharged in less than 24 hours with the diagnosis of static vision, hypothyroid and status post syncopal episode. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event passed out/status post syncopal episode and static vision/double vision were resolved. The outcome of the events hypothyroidism, diarrhea, injection site pain, and headache were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: MOD21-024368:Crosslinked: Same reporter MOD21-024340:Crosslinked: Same reporter MOD21-024343:Crosslinked: Same reporter MOD210-24360:Crosslinked: Same reporter MOD21-024387:Crosslinked: Same reporter MOD21-024396:Crosslinked: Same reporter MOD21-024411:Crosslinked: Same reporter",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/24/2020,12/24/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No adverse event history.),,,"['Angiogram', 'Computerised tomogram head', 'Diarrhoea', 'Diplopia', 'Headache', 'Hypothyroidism', 'Injection site pain', 'Loss of consciousness', 'Visual snow syndrome']",1,MODERNA, 1048197,FL,78.0,M,"Oxygen level was down; Tested positive for COVID; A spontaneous report was received from a consumer, concerning a 78-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced oxygen level was down and tested positive for COVID-19. The patient's medical history included heart disease and atrial fibrillation. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 18 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 012120A] intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced low oxygen levels. On 08 Feb 2021, the patient tested positive for COVID-19. Treatment for the event included hospitalization. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events oxygen level was down and tested positive for COVID were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/18/2021,02/08/2021,21.0,UNK,,"Atrial fibrillation; Heart disease, unspecified",,,,"['COVID-19', 'Oxygen saturation decreased', 'SARS-CoV-2 test positive']",1,MODERNA,OT 1048198,,,F,"Was like hallucinating; A spontaneous report was received from a consumer, a 90 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced was like hallucinating/hallucination. The patient's medical history was not provided. Concomitant product use was not provided. On 09 Feb 2021, the same day of the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A) in the left arm for prophylaxis of COVID-19 infection. After getting the vaccine, the patient had lunch and went home. The patient arrived home two hours after receiving the vaccine and fell asleep. When the patient opened her eyes after the nap, she saw her phone in front of her and reported the letters were moving as if she was writing; however, the patient reported that she was not even holding the phone and that the phone was still plugged in. The patient stated, ""I was like hallucinating"". Treatment for the event included was not reported. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,02/09/2020,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Hallucination'],1,MODERNA, 1048199,AZ,49.0,F,"hives; facial swelling; throat swelling; throat itching; nausea; anaphylactic reaction/ Anaphylaxis; This is a spontaneous report from a contactable physician via FDA. A 49-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in the arm on 17Dec2020 at 13:30 at 0.3 ml, single dose for covid-19 immunization. Medical history included ongoing essential hypertension, ongoing protein c deficiency, ongoing lumbosacral radiculopathy, ongoing type 2 diabetes mellitus, ongoing pulmonary embolism, Strep pharyngitis from 29Nov2020 and resolved at the time of vaccination, serious allergic reaction, allergy to iodonated contrast media and Cardiac Arrest after IV contrast. Concomitant medication included apixaban (unknown manufacturer) for Protein C Deficiency, metformin hydrochloride (unknown manufacturer) for Type 2 Diabetes, chlorthalidone (unknown manufacturer) for hypertension, metoprolol (unknown manufacturer), clonidine hydrochloride (unknown manufacturer) for hypertension, atorvastatin (unknown manufacturer), magnesium oxide heavy;tocopheryl acetate (unknown manufacturer), tramadol hydrochloride (unknown manufacturer), diphenhydramine hcl (unknown manufacturer), epinephrine bitartrate (unknown manufacturer) for serious allergic reaction and anaphylaxis. On 17Dec2020 at 13:48, approximately 13min after vaccination while in observation the patient experienced hives, facial swelling, throat swelling/itching, and nausea. Patient was immediately taken to Emergency Department where epinephrine was given 1M in the left thigh followed by 125mg IV solumedrol, 50mg IV benadryl, 1000mL NS, and 20mg IV famotidine. Hemodynamically stable throughout ED course. The events were considered serious as per hospitalization. Medical Tests and Laboratory results related to the adverse event included: CRP: 11.0, Glucose-182, BRN-29, INR-1.1, Remained of CMP and CBC were WNL. The physician stated that anaphylactic reaction onset 6min after vaccination symptoms improved - 20min after epipen administration, Resolved 60 min later. The signs and symptoms of anaphylactic reaction included Diffuse rash, Itching, throat/lip swelling, shortness of breath, cough, BP 128/72, Spon-97% HR-71. The patient rushed to ED from vaccination PoD. Received EpiPen approximately 8 min post vaccination. Then received steroid, antihistamines, IVF. Sx improved in 20 min resolved 60 min. The patient was not hospitalized and not admitted to an intensive care unit for anaphylactic reaction. The physician stated that multiorgan involvement included respiratory, dermatological/mucosal. Also reported as Respiratory: Yes; Upper airway swelling: Yes; Respiratory distress: Yes; Tachypnoea: Yes; Dry cough: Yes; Difficulty breathing (without wheeze or stridor):Yes; Dermatological/Mucosal: Yes; Generalized urticarial: Yes; Angioedema (not hereditary): Yes; Generalized pruritus with skin rash: Yes. The following laboratory tests or diagnostic studies performed included Hematology on 17Dec2020 showed: results with units, if applicable: 8/13/299/41; Clinical chemistry on 17Dec2020 showed: results with units, if applicable: 137,103,29/36,22,07 (Less than sign) 182; CRP on 17Dec2020 showed: results with units, if applicable: 11.0. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient had not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient had anaphylaxis on 17Dec2020 at 13:36. The patient was not deceased and received treatment. Treated in emergency room/ epinephrine IM IV steroids, antihistamines, IV fluids. The physician considered the Pfizer product had a causal effect to the adverse event. The outcome of the event anaphylactic reaction/ anaphylaxis was recovered on 17Dec2020, while other events were recovered on 17Dec2020 at 13:48. Information on the lot/batch number has been requested. Follow-up (08Feb2021): New information received from the contactable Physician included: additional medical history and lab data, concomitant medications details, suspect drug information (lot number, dosage regimen details), event information (new event ""anaphylactic reaction/ Anaphylaxis"") and other clinical courses.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events anaphylactic reaction/Anaphylaxis urticaria, swelling face, pharyngeal swelling, throat irritation and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,APIXABAN; METFORMIN [METFORMIN HYDROCHLORIDE]; CHLORTHIAZIDE; METOPROLOL; CLONIDINE [CLONIDINE HYDROCHLORIDE]; ATORVASTATIN; MAGNESIUM OXIDE HEAVY;TOCOPHERYL ACETATE; TRAMADOL [TRAMADOL HYDROCHLORIDE]; DIPHENHYDRAMINE HCL; EPINEPHRINE [EPIN,Essential hypertension; Lumbosacral radiculopathy; Protein C deficiency; Pulmonary embolism; Type 2 diabetes mellitus,Medical History/Concurrent Conditions: Allergic reaction; Cardiac arrest; Iodine contrast media allergy; Pharyngitis streptococcal (Strep pharyngitis 29Nov2020 resolved at the time of vaccination.),,,"['Anaphylactic reaction', 'Blood glucose', 'Blood pressure measurement', 'Full blood count', 'Haematology test', 'Heart rate', 'International normalised ratio', 'Laboratory test', 'Metabolic function test', 'Nausea', 'Pharyngeal swelling', 'Swelling face', 'Throat irritation', 'Urticaria']",1,PFIZER\BIONTECH,OT 1048200,NJ,63.0,F,"Trigeminal Neuralgia; Nausea; Chills; Body aches; Lightheadedness; Trigeminal nerve disorder; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot: EL1284/expiration date not provided) via intramuscular route of administration, in left arm, on 19Jan2021 (at the age of 63 years old) as a single dose for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included losartan, amlodipine, metoprolol, esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL0140/expiration date not provided) on 29Dec2020 (at the age of 63 years old) as a single dose in the left arm for COVID-19 immunization. On 20Jan2021, the patient experienced nausea, chills, body aches, lightheadedness, trigeminal nerve disorder. On 22Jan2021, the patient was diagnosed with trigeminal neuralgia. The events resulted in a physician office visit and Emergency Room visit. The seriousness criteria was disabling/incapacitating. The facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been not been tested for COVID-19. Treatment received for the events included steroids, anti-convulsant and pain relievers. The outcome of the events was not recovered. Follow-up (08Feb2021): New information from a contactable nurse (patient) includes: new event (trigeminal neuralgia), event details, seriousness criteria, treatment received and events outcome.; Sender's Comments: Based on the plausible temporal association and considering lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported events, nausea, chills, body aches, lightheadedness, trigeminal nerve disorder, Trigeminal Neuralgia and the administration of the COVID-19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/19/2021,01/20/2021,1.0,PVT,LOSARTAN; AMLODIPINE; METOPROLOL; NEXIUM [ESOMEPRAZOLE MAGNESIUM],,,,,"['Chills', 'Dizziness', 'Nausea', 'Pain', 'Trigeminal nerve disorder', 'Trigeminal neuralgia']",2,PFIZER\BIONTECH,OT 1048201,CA,66.0,F,"Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Scarring; This is a spontaneous report from a contactable nurse (patient herself). A 66-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EK4176), via an unspecified route of administration in the left arm on 19Jan2021 at 10:00 as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not have any other vaccine in four weeks, did not have other medications in two weeks, did not have COVID prior to vaccination, has no known allergies, and was not pregnant. There were no concomitant medications. On 24Jan2021 at 08:00, the patient experienced pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on the vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm erupted after 4 more days. Scarring and itching up for two weeks. The patient was not tested for COVID after vaccination. As treatment, Permethrin cream was used to see if it was scabies to ""no eff"". The adverse events resulted in a doctor or other healthcare professional office/clinic visit and disability or permanent damage. Outcome of the events was recovering.; Sender's Comments: Based on temporal association and/or known drug profile a contributory role of BNT162B2 to the reported events cannot be totally excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/19/2021,01/24/2021,5.0,PUB,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Acarodermatitis', 'Blister', 'Pruritus', 'Rash', 'Scar']",1,PFIZER\BIONTECH, 1048202,NC,76.0,F,"passed out / fell; passed out / fell; developed a nose bleed that would not stop; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. Medical history included high blood pressure, diabetic, stage 3 kidney disease, known allergies to penicillin. The patient's concomitant medications were not reported. It was reported that patient got the shot on Thursday morning (04Feb2021) and later that evening reported as at 10:00pm, the patient developed a nose bleed that would not stop. By 10:30pm she passed out/fell, site car management was called and she was sent to the ER where she stayed for evaluations for 2 days. The reporter does not think the Covid shot was connected to the event. No treatment was given to the patient. The patient had no covid prior to vaccination and was not tested for covid post vaccination. The patient was recovering from the events at the time of the report. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,SEN,,,Medical History/Concurrent Conditions: Blood pressure high; Chronic kidney disease stage 3; Diabetic; Penicillin allergy,,,"['Blood pressure measurement', 'Epistaxis', 'Fall', 'Loss of consciousness']",UNK,PFIZER\BIONTECH, 1048203,PA,73.0,F,"I had passed out hitting a table bumped head and back.; very dry mouth; felt very light headed; Thought maybe I may have been dehydrated; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at Left arm on 06Feb2021 07:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included High blood pressure. Concomitant medications included losartan, atorvastatin calcium (LIPITOR) and vitamins. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient woke up 1:30 am 07Feb2021very dry mouth, used restroom, felt very lightheaded, went back to room, next thing she heard was glass breaking. She had passed out hitting a table bumped head and back. Her boyfriend was with she helped she up. Said her legs went out from under her. Thought maybe she may have been dehydrated though she had drunk water throughout the day and before bedtime. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/07/2021,1.0,PVT,LOSARTAN; LIPITOR [ATORVASTATIN CALCIUM],,Medical History/Concurrent Conditions: Blood pressure high,,,"['Dehydration', 'Dizziness', 'Dry mouth', 'Loss of consciousness']",UNK,PFIZER\BIONTECH, 1048204,NC,53.0,F,"Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure was out of control; dizziness does not allow her to go to work; lingering dizziness; Get a tightening in her chest; Fatigue; Left side of temple toward the crown of head she has pressure on the left side of the body; Left side of temple toward the crown of head she has pressure on the left side of the body; lightheadedness; troponin kept increasing; Inflammation around heart; This is a spontaneous report from two contactable consumers or other non health professional (including patient self, a healthcare worker works with patients with lymphomas, a licensed massage/lymphatic therapist). This 53-years-old female received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, Expiry Date: 30Apr2021) at 0.3 ml single dose intramuscular injection in left arm on 22Jan2021 10:28 (also reported as 10:38) for Covid-19 vaccination. Medical history was none (also reported as no patient history). Concomitant drug was none (reported as no other products). Family Medical History Relevant to AE(s) was none. Historical vaccine included flu shot in Nov2020 for immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No other vaccines given the same day or 4 weeks prior. AE(s) following prior vaccinations was none. Patient never had a reaction to any vaccine or shot before. Patent experienced anaphylactic reaction on 22Jan2021, heart enzymes elevated on 22Jan2021, blood pressure was out of control on 22Jan2021, get a tightening in her chest on an unknown date, lingering dizziness on an unknown date, dizziness did not allow her to go to work on an unknown date, inflammation around heart on 22Jan2021, troponin kept increasing on 22Jan2021, fatigue on an unknown date, lightheadedness on an unknown date, left side of temple toward the crown of head she has pressure on the left side of the body on an unknown date. Seriousness for heart enzymes elevated and anaphylactic reaction was hospitalization from 22Jan2021 to 23Jan2021. The events anaphylactic reaction required a visit to Emergency Room, but not Physician Office. The event clinical course was as follows: patient received her 1st dose of the Pfizer vaccine she had an anaphylactic reaction. She was given 3-4 Epis on site (on 22Jan2021) before being transferred to the ER. In the ambulance, she was administered a 4th EpiPen (on 22Jan2021) before getting to the ER, and then admitted to the cardiac unit on 22Jan2021 for observation. Patient also reported Given 3-4 EpiPens on 22Jan2021 and EpiPen auto-injector was Lack of Effect. No Return Sample Received. When she first started having symptoms, her blood pressure was 128/73. When the symptoms got worse her blood pressure started increasing. Her blood pressure was 220/116, they had to admit her to the cardiac unit because her heart enzymes were elevated and her blood pressure was out of control. Her troponin kept increasing and had inflammation around her heart. Her symptoms of anaphylactic reaction went away that same day, 22Jan2021, at the vaccination from her anaphylactic reaction. Patient was discharged and released from the cardiac unit on that Saturday (23Jan2021 ) around 7:30pm. No one could tell her anything about this since she was still having lingering effects and was getting ready to locate a cardiologist and still has tightness in the chest. She mentioned the dizziness did not allow her to go to work. She experiences it on and off, not consistent but less severe than initially. She still had lingering dizziness and she had to drive for a majority of her day and that was concerning. She said that on the left side she will get a tightening in her chest. She said that no one knows what this means moving forward. Patient was concerned about the severity of the reaction and was still not back to normal. She had never had a reaction to any vaccine or shot before and has been in the military. She needed help, direction since she was still not at the full potential to work. She was still fatigued and has tightness of her chest and those are concerns for her. Patient mentioned a part of the symptoms she also had were lightheadedness and dizziness and that started after the vaccine and it's not as severe, but she still had it. On left side of her temple toward the crown of her head she had pressure on the left side of the body and that was the same side where she received the injection, on that left side. Outcome of anaphylactic reaction was resolved with sequel on 22Jan2021. Outcome of heart enzymes elevated was resolved on 23Jan2021. Outcome of blood pressure was out of control was resolved with sequel on 23Jan2021. Outcome of lingering dizziness was resolving. Outcome of left side of temple toward the crown of head she had pressure on the left side of the body, lightheadedness was not resolved. Outcome of tightness in the chest and fatigue was not resolved. Outcome of inflammation around heart and troponin kept increasing was resolved with sequel on an unknown date. Outcome of the other event was unknown.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/22/2021,01/22/2021,0.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Anaphylactic reaction', 'Blood pressure measurement', 'Chest discomfort', 'Discomfort', 'Dizziness', 'Fatigue', 'Head discomfort', 'Hypertension', 'Impaired work ability', 'Myocardial necrosis marker', 'Myocardial necrosis marker increased', 'Myocarditis', 'Troponin', 'Troponin increased']",1,PFIZER\BIONTECH,OT 1048205,,,M,"he has chronic myeloid leukemia - white blood cell count is higher; His oxygen is low; Blood clot in his legs; first dose on 19Jan2021 and second dose on 02Feb2021; first dose on 19Jan2021 and second dose on 02Feb2021; This is a spontaneous report from a contactable nurse reported for her father that an 82-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Feb2021 at single dose for covid-19 immunisation. Medical history included chronic myeloid leukemia (CML). Concomitant medications were not reported. Patient previously received first dose of BNT162B2 on 19Jan2021 at single dose for covid-19 immunisation. Patient received Pfizer-BioNTech COVID-19 Vaccine first dose on 19Jan2021 and second dose on 02Feb2021. Two days after second dose (04Feb2021) he had to go to the hospital - he had chronic myeloid leukemia - white blood cell count was higher (Feb2021), he had been in the hospital for the last 3 days as of 08Feb2021, his oxygen was low, had a blood clot in his legs, had a bone marrow biopsy, all on an unspecified date in Feb2021. The nurse is taking its related to this vaccine and assessed this case as not serious. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/02/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Chronic myeloid leukemia,,,"['Biopsy bone marrow', 'Chronic myeloid leukaemia recurrent', 'Inappropriate schedule of product administration', 'Off label use', 'Oxygen saturation', 'Oxygen saturation decreased', 'Thrombosis', 'White blood cell count']",2,PFIZER\BIONTECH, 1048206,NY,77.0,M,"Immune system was destroying red blood cells that caused Hemoiytic Anemia; This is a spontaneous report from a contactable consumer (patient) reported that a 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 35235643), via an unspecified route of administration on the left arm on 22Jan2021 13:00 at a single dose for covid-19 immunization. The vaccine was administered at the hospital. Medical history included Type 2 diabetic, high blood pressure, and high cholesterol; all from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin, clopidogrel, metformin, pravastatin, and metoprolol; all were taken from an unspecified date for an unspecified indication. The patient experienced immune system was destroying red blood cells that caused hemolytic anemia on 28Jan2021 with outcome of recovering. The reported event led to patient's hospitalization for 8 days. The treatment received for the event was prednisone. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-1 test (nasal swab): negative on 31Jan2021.",Not Reported,,Not Reported,Yes,8.0,Not Reported,N,01/22/2021,01/28/2021,6.0,PVT,GABAPENTIN; CLOPIDOGREL; METFORMIN; PRAVASTATIN; METOPROLOL,,Medical History/Concurrent Conditions: Blood pressure high (High blood pressure); High cholesterol; Type 2 diabetes mellitus (Type 2 diabetic),,,"['Autoimmune haemolytic anaemia', 'SARS-CoV-1 test']",1,PFIZER\BIONTECH, 1048207,NY,43.0,F,"numbness of face; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; menstral cycle thrown off by 10 days; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: not available/provided to reporter at the time of report completion), intramuscular, Left arm on 06Jan2021 13:45 at single dose for covid-19 immunization. Age at vaccination was 43 years. Patient was not pregnant at the time of vaccination. Medical history included Hoshimotos and Acid reflux. Allergies to medications, food, or other products included sulfa allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications received within 2 weeks of vaccination included omeprazole 40mg, paroxetine 20mg. On 06Jan2021 14:00, the patient experienced swelling and itching of tongue and lips within 15 min, numbness of face the next day (on 07Jan2021) continuing for several weeks. Menstral cycle thrown off by 10 days. The events resulted in emergency room/department or urgent care. Recovered with lasting effects. Benadryl, pepcid and prednisone treatment was received for the events. Events outcome was recovered with sequelae. Information on the lot/batch number has been requested.; Sender's Comments: Based on the strong temporal relationship, the association between the vaccine and the events swollen tongue, lip swelling, tongue pruritus, lip pruritus, hypoaesthesia cannot be completely excluded. Delayed menstruation is probably an intercurrent condition for which the patient's age is also a contributing factor. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,OMEPRAZOLE; PAROXETINE,,Medical History/Concurrent Conditions: Acid reflux (oesophageal) (acid reflux); Hashimoto's disease (hoshimotos); Sulfonamide allergy (sulfa allergy),,,"['Hypoaesthesia', 'Lip pruritus', 'Lip swelling', 'Menstruation delayed', 'Swollen tongue', 'Tongue pruritus']",1,PFIZER\BIONTECH,OT 1048208,VA,82.0,M,"passed out; felt lightheaded; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the right arm on 25Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included hypertension, hypothyroidism, high cholesterol. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. On 25Jan2021, the patient felt lightheaded since vaccine. On 02Feb2021, the patient passed out. The patient has never passed out before. He went to the cardiologist on 04Feb2021 and had EKG and review of BP readings and HR readings etc., all checked out ok. Today was 08Feb2021 and still lightheaded. The cardiologist suggested we call you but cannot get through. We were extremely concerned about getting the 2nd vaccine because of reports of worse symptoms with that one. We cannot get through to you and do not know what to do. The 2nd vaccine was scheduled for 15Feb2021.The events resulted in doctor or other healthcare professional office/clinic visit. The patient has not recovered from the events. Treatment was received for the event passed out and ordered Exam-EKG-Holter Monitor. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,UNK,,,Medical History/Concurrent Conditions: High cholesterol; Hypertension; Hypothyroidism,,,"['Blood pressure measurement', 'Dizziness', 'Electrocardiogram', 'Heart rate', 'Loss of consciousness']",1,PFIZER\BIONTECH, 1048209,IN,89.0,M,"Bleeding from right kidney; Bleeding from right kidney; Left kidney is shrunken and function at about 10%; Left kidney is shrunken and function at about 10%; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL8982), via an unspecified route of administration on an unspecified date in Feb2021 (19:00) at single dose (at the age of 89-year-old on Left arm) for COVID-19 immunization. Medical history included arthritic knees and shoulder, prostate cancer, macro degeneration, hearing loss, congestive heart failure, Last right kidney bleed one a year ago (2020 to 2020). The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered:Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient had no known allergies to medications, food, or other products. Patient had Bleeding from right kidney into nephoscimy bag. No noticeable bold from bladder. Left kidney is shrunken and function at about 10%. All events from 06Feb2021 04:00. No treatment was received in response to the events. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/06/2021,5.0,PVT,,,Medical History/Concurrent Conditions: Arthritis (arthritic knees and shoulder); Congestive heart failure; Degeneration macular (macro degeneration); Hearing loss; Prostate cancer; Renal bleeding (right kidney bleed one year ago),,,"['Disease recurrence', 'Renal atrophy', 'Renal function test', 'Renal haemorrhage', 'Renal impairment']",1,PFIZER\BIONTECH, 1048210,WI,88.0,M,"Bleeding out of ileostomy; Did not sleep; no appetite; Feeling unwell; achy; tired; weaker; This is a spontaneous report from a contactable consumer (patient's daughter). An 88-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283), intramuscular on 30Jan2021 09:45 at SINGLE DOSE in left arm for Prevention. Medical history included Type 2 diabetes diagnosed 10 years ago, Quadruple Bypass surgery in 2003, High blood pressure. He was Diabetic, was a heart patient. Before he had his ostomy, he had colitis that causes the patient to bleed when pooping and his guts were ravaged. His stomach might be weakened from having it for years and years in his 30's, 40's to early 50's. Family medical history included Grandfather died at 42 of bleeding ulcer in his stomach. There were no concomitant medications. Prior Vaccinations within 4 weeks was none. He has allergies to pills but was not taking any. He does not have a fever. She has the names of the pills he is allergic to as follows: Simvastatin, Lisinopril, Losartan, Aggrenox cap. They are listed on his report from (institution name withheld) that he has allergies to. He received his first dose of the Pfizer COVID-19 vaccine on 30Jan2021. There was no prescriber on 30Jan2021 through 01Feb2021, everything was good. On 02Feb2021, that is when his ostomy shot out blood like a faucet when he was taking a shower. He was changing the bandage that day, he was changing his right sided ileostomy bag and he told her that blood shot out of it ""like a faucet."" On 3Feb2021 was nerve wracking, but there was no blood. He was changing his ostomy pad again on 04Feb2021 and it started bleeding so much that he went to the hospital. He was discharged within a few hours because ""they couldn't find anything wrong."" He has had colitis for years and has an ileostomy, where they take out a bunch of his colon. This week he has had some funny bleeding in his ileostomy. It was spurting out blood. He had to go to the ER on 4Feb2021 night because it was bleeding and then it stops. People in ER did not know what the bleeding was from. He was bleeding in the ileostomy on 04Feb2021 and 05Feb2021. On 05Feb2021 his ostomy bled a little bit more but it has not bled again since 06Feb2021. She also reports that he feels, "" icky, tired, no appetite and achy."" The feeling unwell began on 7Feb2021. That worsened since loss of blood made him weaker and worried. When he got back from the hospital/ER, he said they were rude. There was a blizzard. He checked in around 8pm and they discharged him around 11pm that same night. ER visit at the institution on 04Feb2021, 8pm to 11pm and released. They performed CT scan abdomen and Pelvis and IV. Results are unknown. Now he was good. The achiness and tiredness was between persistent and worsened. He was worrying now. She took his forehead temperature and it was good on 7Feb2021. She took everybody's and they were all good. He just feels icky and the blood thing is nerve wracking. He is convinced it is coming back. He was not on a blood thinner or anything listed on the vaccine fact sheet. The patient experienced Feeling unwell on 6Feb2021 with outcome of Not Recovered (Feeling unwell was reported as worsened), achy and tired on 5Feb2021 with outcome of unknown, No appetite on 7Feb202108:30 with outcome of Not Recovered, Bleeding out of ileostomy on 2Feb2021 09:45 with outcome of Recovering, Did not sleep on 7Feb2021 21:30 with outcome of Not Recovered. He has a lot of the risk factors; He is Diabetic, is a heart patient, and has high blood pressure, but he really wanted to get the shot. The patient's primary care provider's nurse do not believe the bleeding had anything to do with the Pfizer COVID-19 vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/30/2021,02/01/2021,2.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure high; Bypass surgery; Colectomy; Colitis (he had colitis that causes the patient to bleed when pooping and his guts were ravaged.); Heart disorder; Ileostomy; Ostomy bag placement; Stomach discomfort (Grandfather died at 42 of bleeding ulcer in his stomach); Type 2 diabetes mellitus (diagnosed 10 years ago),,,"['Asthenia', 'Body temperature', 'Computerised tomogram', 'Computerised tomogram abdomen', 'Computerised tomogram pelvis', 'Decreased appetite', 'Fatigue', 'Malaise', 'Pain', 'Sleep disorder', 'Stoma site haemorrhage']",1,PFIZER\BIONTECH,OT 1048211,NY,64.0,M,"a genitourinary infection (UTI)/diagnosed with a gram negative urinary tract infection; iron level was low at 21. He said a normal iron level for a male is 35; couldn't walk afterwards; Tiredness; another soft tissue injury; Headache; left eye was totally blurry/ one eye blurriness; has severe eye dryness; Injection site pain; Injection site redness; injection site puffiness; stated he noticed at around 2:30PM-3:00PM he had a rash on his hip and back; shingles/ shingles pain; a fever of 100.4 Degree F/Fever; This is a spontaneous report from a contactable pharmacist (patient) reported similar events for two patients. This is the first of two reports. A 64-year-old male patient receive first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), at same age intramuscular in arm left on 16Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included fallen at work and landed on his left side, hitting his head and left knee, a knot on the left side of his head, bleeding from above his left eyebrow, had a left black eye, all on Nov2020, subarachnoid hemorrhage, cataract surgery, using crutches when he walks, in the hospital from Nov2020 to 17Nov2020, pacemaker implanted while he was in the hospital on Nov2020, he couldn't walk on 19Nov2020, 6 stents, 3 cardiac stents on Oct2020, and chicken pox as a young adult. Concomitant medication included aspirin [acetylsalicylic acid], clopidogrel bisulfate (PLAVIX) from unspecified date to 27Jan2021 for 6 stents, paracetamol (TYLENOL, 500 mg, caplets, NDC Number: 5058044936, Lot Number: SJA066 and Expiration Date: Jul2024). The patient said he received his first COVID-19 Vaccine dose on 16Jan2021. He said at the time he pre-medicated with 2 paracetamol. He said he had read afterwards that it is not recommended to pre-medicate with Tylenol before receiving the COVID-19 Vaccine. On 24Jan2021 he developed a fever of 100.4 Degree F (body temperature). He stated his fever was 8 days after receiving his first COVID-19 Vaccine dose. On 27Jan2021, he was urinating blood/blood clots and was admitted to the hospital and treated for a UTI. He was diagnosed with a genitourinary infection (UTI). He clarified on the morning of 27Jan2021 his urine looked darker than normal. He said he went to physical therapy (PT) on 27Jan2021. He said when he came back from PT, and went to the bathroom, there was blood and blood clots in his urine. He said he called his urologist, and his urologist saw him on 27Jan2021. He said his urologist took a urine sample, and his urine sample was clear and negative for nitrites. He clarified his urologist did a digital prostate exam, and his prostate was fine. He said his urologist wanted him to make an appointment for a cystoscopy, and a CAT scan of his abdomen and pelvis. He said after he got home from the urologist, he went to the bathroom, and again had blood and blood clots in his urine. He went to emergency room. While he was in the Emergency Room, he was set-up on CBI (Continuous Bladder Irrigation). He said the urologist did not seem concerned about the amount of blood in his urine. He clarified he was admitted to the hospital, and had in place for approximately 16 hours. Next day (28Jan2021) he was diagnosed with a gram negative urinary tract infection. He said he was given a daily dose of IV Ceftriaxone 1gram on 29Jan2021 and 30Jan2021. He said he was also given a daily dose on 29Jan2021 and 30Jan2021 of IV Ferrlecit 125mg because his iron level was low at 21. He said a normal iron level for a male is 35. On 31Jan2021 he had injection site pain in his left arm, he said the COVID-19 Vaccine injection site was red and puffy. He said the COVID-19 Vaccine injection site pain, redness, and puffiness resolved on the same day, 31Jan2021. He said his second COVID-19 Vaccine dose was given in the same arm (left) on 06 Feb2021. He stated he asked that the second COVID-19 Vaccine dose be given in the same arm (left) because his left arm is his non-dominant arm. He was discharged from the hospital on 30Jan2021, and was given a prescription to take 1 Levaquin 250mg orally for 3 days starting on 31Jan2021. He said the Levaquin 250mg was dispensed in a pharmacy bottle, and did not have the NDC, Lot, and Expiration Date. He said he was also prescribed oral Feosol 325mg, twice a day, starting on 31Jan2021. He provided the Feosol 325mg, NDC Number: 12451-10-17 (unsure if he provided the correct NDC), Lot Number: 201167, and Expiration Date: Jul2022. At around 2:30-3:00PM on 31Jan2021, he developed a rash on his hip and back, saying the hip and back rash were along the same pathway. He said he spoke to a PA (physician assistant) about his rash. He said on 31Jan2021 he had taken 1 oral dose of the Levaquin 250mg. He said the PA discontinued the oral Levaquin 250mg, and changed his prescription to Macrobid 100mg, twice a day, for 5 days. He said he started the Macrobid 100mg, twice a day, on Monday, 01Feb2021. He said he completed the Macrobid 100mg prescription on Sunday, 07Feb2021, and did not have the Macrobid 100mg NDC, Lot and Expiration Date. He clarified his rash was raised, oozy, and looked weird, like a pimple that came to head. He said he spoke to his dermatologist on a video call Sunday, 31Jan2021. He said his dermatologist told him he had shingles and prescribed Valtrex 1gram, three times a day, for 7-10 days. He stated the Valtrex 1gram was dispensed in a pharmacy bottle. He said he took his first Valtrex 1gram dose on Sunday evening, 31Jan2021, and was still taking the Valtrex 1gram as of today (08Feb2021). He had an appointment to see his dermatologist in person on Wednesday, 03Feb2021, but woke up with a wicked headache that morning, so he took paracetamol and went back to sleep. He said when he woke, he still had headache, and his left eye was totally blurry. He said back in Nov2020 he had fallen at work and landed on his left side, hitting his head and left knee. He said his fall left him with a knot on the left side of his head, and he had bleeding from above his left eyebrow, and had a left black eye. He said he also had a subarachnoid hemorrhage. He said he had a CT scan of his head that showed the subarachnoid hemorrhage was contained, so the doctors wanted to just monitor him. He said he was on Effient at the time and the doctors changed him to Plavix. He said he also was taking Aspirin 81mg. He said he was taken off of Plavix on 27Jan2021 when he was admitted to the hospital for having blood and blood clots in his urine. He said he continues to take the Aspirin 81mg daily. He clarified he has been on compensation since his fall in Nov2020. He said he also had cataract surgery 2 years ago. He said he immediately called his eye doctor, and then went to the hospital Emergency Room because he thought he had a stroke. He said the Emergency room did a CAT scan and CTA of his head, which were both normal. He said a neurologist saw him in the Emergency Room, and said since it was a headache with one eye blurriness, he should see his eye doctor. He said the neurologist told him if he had a headache and both eyes were blurry, it would more likely have been a stroke. He stated when he was discharged from the Emergency Room on 03Feb2020, he went directly to his eye doctor. He said his eye doctor did several tests: field of vision, a sonogram, pictures of his left eye, and a dilation of his eyes. He said he had an eye test where he looked at a half circle and clicked a counter when he saw dots, and another eye test where he stared at something that looked like a hot air balloon, while the eye doctor took measurements. He said the eye doctor also measured his eye pressure, which was normal. He said he was at his eye doctor's office for a good couple of hours. He said his eye doctor told him that he has little white dots on the background area of his eyes that indicates he has severe eye dryness. He said his left eye is much worse than right eye. He said his eye doctor asked him if he took Crack, or Cocaine, or any kind of opioids in the last few weeks. He said he told his doctor he took 1 dose of an opioid on 31Jan2021 because of the shingles pain. He clarified he had a Percocet prescription leftover from his hospitalization in Nov2020. He said he took another dose of the Percocet the week before 31Jan2021 for pain in his knee from the fall he had in Nov2020. He said his eye doctor told him his dry eyes could be caused by the Percocet. He said his eye doctor prescribed lubricating eye drops (Refresh Optive Mega 3, UPC Number: 0023577330, Lot Number: T095, and Expiration Date: Aug2022), that he is to use in both eyes every hour, and an eye ointment in his left eye only at bedtime. He had been using crutches when he walks because of the problem with his right knee since he fell in Nov2020. He said on 06Feb2021, he took a shower, and when he went to get out of the shower, his right leg gave out. He said he didn't fall, but he couldn't walk afterwards. He said he went to the Emergency Room on 06Feb2021, and an x-ray and sonogram were done of his right knee. He said he was told he had another soft tissue injury like he had when he fell back in Nov2020. He said he was given a leg immobilizer to use. He said when he first fell in Nov2020, he originally fell on his left knee. He said he has had PT since being discharged from the hospital on 17Nov2020. He said he also had a pacemaker implanted while he was in the hospital in Nov2020. He said after his discharge from the hospital on 17Nov2020, he went to take shower at home on 18Nov2020 and his left knee gave out. He said he was able to lower himself to the floor in the shower stall, but he couldn't get out of the shower stall. He said he was left sitting on his left leg and he couldn't use his right leg. He said he finally got himself to bed, and iced his right knee because he sat on it for over an hour. He said the next day (19Nov2020), he couldn't walk and had to have an ambulance take him to Emergency Room. He said he hasn't had PT since 27Jan2021, and needs clearance from his doctor before he can restart PT. He said he has been without PT for 2 weeks now. He said on 06Feb2021 he was unable to get a MRI on his knee because he had too much swelling that would have made the MRI imaging cloudy. On 06Feb2021 he was due for his second COVID-19 Vaccine, so before he was discharged from the Emergency Room he was given his second COVID-19 Vaccine dose. He was using the Refresh Optive Mega 3 eye drops constantly now. He said he had no fever, but is more tired than in the past. He said the last couple of days he can sleep for hours, and wake up and feel like he can go right back to sleep. He said he and his cardiologist are concerned because since 27Jan2021, he has only been on Aspirin 81mg. He said he has 3 cardiac stents since Oct2020, and should be on dual therapy. He said he had a CT of his abdomen and pelvis while he was in the hospital. He said he has been off of Plavix since 27Jan2021, and can restart the Plavix until he has a cystoscopy. He wants to know if UTIs in men are common after getting the COVID-19 Vaccine, so he can decide if he should cancel the cystoscopy and restart his Plavix. The second COVID-19 Vaccine Lot number as EL9261 or EI9261. He stated the vaccine lot number was handwritten on his COVID-19 Vaccine immunization card and was difficult to read the handwritten vaccine lot number. The patient underwent lab tests and procedures which included bacterial sepsis: gram negative urinary tract infection on 28Jan2021. Clarified he had no pain, burning, or urgency with the UTI. He said he was told by the hospital he had gram negative rods in his urine, when he was started on the IV Ceftriaxone on 29Jan2021. He stated he has never had a UTI before. Clarified his body temperature is rarely 98.6 degrees, and is normally 98.2 degrees and he had never had shingles before. He said he had chicken pox as a young adult, and he only had 1 spot of chicken pox. He had never had dry eyes before. Reporter seriousness for fever, UTI, injection site pain, injection site redness, injection site puffiness, rash, shingles were medically significant. For other events were unspecified. The outcome of event injection site pain, injection site redness, injection site puffiness was recovered on 31Jan2021, dry eye, tiredness was not recovered, while the outcomes of other events were unknown.; Sender's Comments: Based on the temporal association and the known possible local reaction, a possible contributory role of BNT162B2 to the development of injection site pain, redness, and puffiness cannot be excluded. The other events are considered as due to underlying or intercurrent conditions and unrelated to the use of BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021134924 same reporter/drug, different patient, similar event",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/16/2021,01/24/2021,8.0,PVT,ASPIRIN [ACETYLSALICYLIC ACID]; PLAVIX; TYLENOL,,Medical History/Concurrent Conditions: Black eye; Bleeding; Cataract; Chickenpox; Coronary arterial stent insertion; Crutch user; Fall; Head injury; Hospitalization; Knee injury; Pacemaker insertion (cardiac); Skin nodule; Stent placement; Subarachnoid hemorrhage; Unable to walk,,,"['Angiogram', 'Bacterial sepsis', 'Blood iron', 'Blood iron decreased', 'Body temperature', 'Computerised tomogram', 'Dry eye', 'Fatigue', 'Gait inability', 'Headache', 'Herpes zoster', 'Intraocular pressure test', 'Investigation', 'Ophthalmological examination', 'Physical examination', 'Pyrexia', 'Rash', 'Soft tissue injury', 'Ultrasound scan', 'Urinary tract infection bacterial', 'Urine analysis', 'Vaccination site erythema', 'Vaccination site oedema', 'Vaccination site pain', 'Vision blurred', 'Visual field tests', 'X-ray']",1,PFIZER\BIONTECH,OT 1048212,,87.0,F,"lightheaded; experience funny feeling in face; HA; Vaccine Related Anxiety; This is spontaneous report from a Non-contactable Other Health Professional. An 87-year-old female patient received first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME, lot# EM9809), intramuscularly in right arm on 04Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15 minutes waiting period after the injection, the patient experienced funny feeling in face, lightheaded and HA (headache) on an unspecified date with outcome of unknown. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. Treatment included: no therapy. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine Related Anxiety (include misc mental health). Patient left at 15:40pm accompanied by husband. Follow up with PMP regarding blood pressure. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/04/2021,02/04/2021,0.0,PVT,,,,,,"['Anxiety', 'Dizziness', 'Feeling abnormal', 'Headache']",1,PFIZER\BIONTECH,OT 1048213,OH,,F,"Site is painful to touch; looks like cellulitis/possible cellulitis; body aches; swollen at injection site; red at injection site; warm at injection site; armpit lymph node still swollen; This is a spontaneous report from a contactable nurse (patient). A female patient not pregnant of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in right arm on 05Feb2021 18:00 at single dose for COVID-19 immunization. Medical history included Allergies: sulfa. Other medical history: none. Concomitant medication in two weeks included trazodone, omeprazole and BCP. The patient previously took oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and experienced Allergies, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Intramuscular 18Jan2021 12:00 PM in right arm for COVID-19 immunization. Facility type vaccine: Workplace clinic. If other vaccine in four weeks: No. If covid prior vaccination: No. If covid tested post vaccination: No. After second injection, right arm became red, warm and swollen at injection site 6 hrs later. After 12 hours, increased redness, warmth, swelling and total body aches. After 24 hours, same as above. After 42 hours, injection site right arm very red, swollen. looks like cellulitis. 72 hours later saw PCp for possible cellulitis vs site reaction. Site is painful to touch, very red, hot, swollen. armpit lymph node still swollen but only pink in color. Script for Keflex sent to pharmacy. Event treatment: cefalexin (KEFLEX) Po. All the events were not recovered. AE resulted in Doctor or other healthcare professional office/clinic visit.; Sender's Comments: The reported event of suspected cellulitis with injection site reactions was possibly related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), considering the temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/01/2021,,WRK,TRAZODONE; OMEPRAZOLE,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,"['Cellulitis', 'Lymphadenopathy', 'Pain', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling', 'Vaccination site warmth']",2,PFIZER\BIONTECH,OT 1048214,MD,72.0,F,"angina; angina; Fever; Chills; Cough; Sore throat; runny nose; Nausea; Diarrhea; Headache; arm heavy; muscle aches and heaviness; muscle aches and heaviness; she just woke up feeling sick; fevers may come like a hot flash; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown), via an unspecified route of administration on 23Jan2021 at a single dose, in left arm for COVID-19 immunization. Medical history included fibromyalgia diagnosed years ago, angina (some stents). There were no concomitant medications. On Jan2021, the patient experienced angina, fever, chills, cough, sore throat, runny nose, nausea, diarrhea, headache, arm heavy, muscle aches and heaviness, and she just woke up feeling sick. The patient experienced multiple AEs after 1st dose of vaccine (received on 23Jan2021). The patient experienced angina later last week. Clinical course: The patient has misplaced card, states her second appointment for the second dose is this Saturday. Caller stated she started having these experiences the day after she was vaccinated with her first dose, received first dose of 23Jan2021. She had fevers, chills, cough- not an aggressive cough, a funny kind of sore throat- like something wrapped around her throat like the muscles of her throat, no congestion but does have a runny nose, states she has some nausea, no vomiting but feeling like she needed to vomit and diarrhea, and headache. The symptoms started about the third day after the vaccine, started with the fevers, stated the fevers may come like a hot flash, lasts seconds even, states you know it is a fever because your bones get hot. These symptom's did not attack her body at one time. Her whole arm stayed heavy, the whole arm not just the injection site, for almost 10 whole days. She previously had fibromyalgia and thought maybe that made the symptoms worse. She had muscle aches and feeling heavy. Her symptoms were spread out over time, no two were at the same time, sore throat was one of the last things. Diarrhea was ongoing, not a runny diarrhea but it was enough to empty stomach and was soft. She was a medic in the military, worked as a Nurse, clarifies she was an LPN and took all the underlying courses to be a PA. One of the issues she found, she thought it may be deadly, as a prior healthcare person and in tune to her body, the people who are in the nursing homes may not be mobile, states so one of the things she felt was just feeling really really sick, that she couldn't put a pin point on it, states she just woke up feeling sick, states she had the urge to get out of bed and got up and after she got up the feeling left her, states a person in the nursing home may just feel really bad and cannot get up, thinks a protocol should be that the people that are immobile should be required to move or if they can't get up they need to move their muscles, people with these symptoms need to get up and get moving. She also has history of angina and a stent, has not had angina in a while and had 3 days where she thought she may need to go talk to her doctor. It was on Wednesday, Thursday and Friday this week. States one of her friends, 92 years old, said she got high after the vaccine and didn't want to talk to anybody, states it was her first dose, she was kind of leery about the 2nd shot, feels like this was kind of aggressive. She had both doses and had no symptoms, but 92-year-old female had no symptoms right away, other than normal body aches and pains, but the next day was high as a kite. Her son has heart disease and she advised him not to take it right now. They were losing a lot of people to the vaccine in nursing homes, no further information provided. This could be affecting good hearts more than damaged hearts, read that this virus likes to work in parts of the body that are already damaged. The outcome of event diarrhea was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, a causal association between the reported angina and BNT162B2 cannot be completely excluded. Note however, that the patient has underlying angina with some stents that may also have contributed to the event. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/01/2021,,SEN,,,Medical History/Concurrent Conditions: Angina pectoris; Fibromyalgia (diagnosed years ago); Stent placement,,,"['Angina pectoris', 'Chills', 'Cough', 'Diarrhoea', 'Discomfort', 'Disease recurrence', 'Headache', 'Hot flush', 'Illness', 'Limb discomfort', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Pyrexia', 'Rhinorrhoea']",1,PFIZER\BIONTECH, 1048215,CA,44.0,F,"Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), at same age, via an unspecified route of administration in left arm on 05Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included metoprolol. The patient previously took ampicillin and experienced drug allergy. The patient experienced dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side. Right side weakness. Only one eye blinks right eye droopy, all on 05Jan2021 10:00. Events resulted in emergency room visit. The patient was hospitalized for 1 days for all events. It was unknown whether treatment was received for all events. Patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 08Feb2021. The outcomes of events were not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side, right side weakness, only one eye blinks right eye droopy, and the administration of the COVID 19 vaccine, BNT162B2, administration, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/05/2021,01/05/2021,0.0,PVT,METOPROLOL,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Ageusia', 'Anosmia', 'Asthenia', 'Cerebrovascular accident', 'Deafness', 'Dizziness', 'Eyelid ptosis', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1048399,PA,102.0,F,Stopped eating and drinking and died,Yes,,Not Reported,Not Reported,,Not Reported,,02/01/2021,02/10/2021,9.0,SEN,"Prilosec 10 mg/daily,Synthroid .110, daily multivitamin","Covid-19 (Pos. antibody 12/20/2020), Dementia","Hiatal Hernia, Dementia",,Penicillin,"['Death', 'Diet refusal']",1,PFIZER\BIONTECH, 1048400,,40.0,F,"Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminophen, I felt very dizzy, nauseous, stay up, couldn't talk, after I drank cold water, I started with profuse sweating followed by chills, also had lower abdominal pain and pain on the left side of the chest. I went to the bathroom and did not have diarrhea. I was finally able to get up with help from my wife. Slow walking. The event lasted about 15 minutes. Since then I've take acetaminophen every 4 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/23/2021,1.0,MIL,No,Sinusitis,No,,No,"['Abdominal pain lower', 'Breast pain', 'Chills', 'Dizziness', 'Hyperhidrosis', 'Injection site discomfort', 'Nausea', 'Speech disorder']",2,PFIZER\BIONTECH,SYR 1048642,NC,,U,"Did not take the fourth dose of Vivotif; Took third dose of Vivotif on day 4; Spontaneous report received on 06JAN2020. A pharmacist reported that a consumer ""took third dose of Vivotif on day 4"" (PT: Inappropriate schedule of product administration) and ""did not take the fourth dose of Vivotif"" (PT: Incomplete course of vaccination) while being on Vivotif for immunisation. The consumer took first, second and third dose of Vivotif on 23DEC2019, 25DEC2019 and 26DEC2019 respectively. It was reported that the consumer did not take the fourth dose. Action taken with Vivotif with respect to the reported events was not applicable. The outcome of the reported events was unknown. Company Comment: A consumer took third dose of Vivotif on day 4"" (Inappropriate schedule of product administration) and also did not take the fourth dose of Vivotif (Incomplete course of vaccination). Considering the nature of the events, the causality of both the events is not applicable to Vivotif.; Sender's Comments: A consumer took third dose of Vivotif on day 4"" (Inappropriate schedule of product administration) and also did not take the fourth dose of Vivotif (Incomplete course of vaccination). Considering the nature of the events, the causality of both the events is not applicable to Vivotif.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2019,12/26/2019,3.0,UNK,,,Comments: The consumer had unknown medical history.,,,"['Inappropriate schedule of product administration', 'Incorrect dose administered', 'Product dose omission issue']",3,"BERNA BIOTECH, LTD.", 1048659,IL,,F,"Tired; Received another dose of the Moderna COVID-19 vaccine the next day; Sore arm; A spontaneous report was received from a consumer, concerning herself, a 76-year-old female patient, who accidently received first dose of Moderna's COVID-19 vaccine and experienced sore arm, received another dose of the Moderna COVID-19 vaccine the next day and was tired. The patient's medical history included sleep deprivation, short term memory loss, hyperparathyroidism, plaque in the artery, heart burn, ocular hypertension, irregular heartbeat, osteopenia, hypertension, cardiac arrhythmia, mitral valve prolapsed, aortic valve prolapsed, DVT, diverticulosis, IBS, rosacea, dry eye, osteoarthritis. Products known to have been used by the patient, within two weeks prior to the event, included Amlodipine, red yeast rice, ezetimibe, latanoprost, propranolol, Irbesartan, Flonase, N-Acetyl-L-Cysteine (NAC), heartburn essential and several supplements. The patient received their first of two planned doses of mRNA-1273 (Lot number:007M20A) intramuscularly in the left arm on 03 Feb 2021. On 04 Feb 2021 approximately 1 day prior to the onset of the events, patient received their second of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient received first dose of mRNA-1273 vaccine on 03 Feb 2021 and was accidently administered second dose of mRNA-1273 vaccine on 04 Feb 2021 from the same facility. Patient called poison center and was told the side effects may be intensified other than that patient should be fine. Patient stated of reading all the side effects and only thing she had was sore arm. Patient was tired because she only got 4.5 hours sleep on 04 Feb 2021 night. She was scared by the event. No treatment information was provided. Consent to follow up was given by her. Action taken with mRNA-1273 in response to the event sore arm was no change. Action taken with mRNA-1273 in response to the events received another dose of the Moderna COVID-19 vaccine the next day and tired were not applicable. The event received another dose of the Moderna COVID-19 vaccine the next day was considered resolved on 04-Feb-2021. The outcome of events, sore arm and tired were considered unknown at the time of this report.; Reporter's Comments: This case concerns a 76-year-old female patient who received their first and second of two planned doses of mRNA-1273 (Lot: 007M20A), reporting Inappropriate schedule of product administration and associated adverse events of vaccination site pain and fatigue. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/03/2021,0.0,UNK,AMLODIPINE; RED YEAST RICE WITH PLANT STEROLS; EZETIMIBE; LATANOPROST; PROPRANOLOL; IRBESARTAN; FLONASE ALLERGY RELIEF; NAC 500; heart burn essential,Memory loss (Short term memory loss for past six months),Medical History/Concurrent Conditions: Aortic valve prolapse; Atherosclerotic plaque; Cardiac arrhythmia; Diverticulosis; Dry eye; DVT; Heartbeats irregular; Heartburn; Hyperparathyroidism; Hypertension; Irritable bowel syndrome; Mitral valve prolapse; Ocular hypertension; Osteoarthritis; Osteopenia; Rosacea; Sleep deprivation (suffered Sleep deprivation for years),,,"['Fatigue', 'Inappropriate schedule of product administration', 'Vaccination site pain']",2,MODERNA,OT 1048660,,,M,"took both of my Moderna shots 14 days apart; A spontaneous report was received from a consumer concerning a 90-year-old, male patient who experienced took both of my Moderna shots 14 days apart. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On unknown date, approximately fourteen days prior to the first dose, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. On unknown date, the patient reported he took both Moderna shots 14 days apart and he never had any reaction. Treatment information was not provided. The action taken with the drug in response to the event is not applicable. The outcome of the event took both of my Moderna shots 14 days apart was unknown.; Reporter's Comments: The reporter refers to a case of inappropriate schedule of product administration for mRNA-1273 vaccine, batch number not provided, with no associated AEs. Causality of this event is not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Inappropriate schedule of product administration'],1,MODERNA, 1048661,,,M,"Lost strength in his limbs, could not walk; Could not walk on his own; Arms and legs got swollen; Pain escalated; A spontaneous report was received from patient's daughter regarding her father who is a 92-year-old, male who experienced lost strength in his limbs and escalated pain to his chest, legs, shoulder, ankles, and hips/ MedDRA PT: [ Lost Strength in Limbs] The patient medical history included Hypertonic and Diabetes. Products known to have been used by the patient, within two weeks prior to the event, included Cephalexin 500 mg for skin infection. On 01 FEB 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID- 19 infection. Patient was hospitalized for two days at the Falmouth Hospital where he underwent a battery of test for Muscular Weakness, could not walk on his own, Arms and legs got swollen, escalated pain to his chest, legs, shoulder, ankles, and hips, not relieved with stronger pain relievers. Daughter stated that her father is getting better but very slowly. Treatment information was not provided/ unknown. Action taken with mRNA-1273 in response to the event was recovering. The Outcome of the events was not reported/unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,CEPHALEXINE,Diabetes; Hypertonic bladder; Skin infection,,,,"['Gait inability', 'Muscular weakness', 'Pain', 'Peripheral swelling']",1,MODERNA,OT 1048662,NY,43.0,F,"Caused some vaccine to end up on the patient's arm and an incorrectly administered dose; Caused some vaccine to end up on the patient's arm and an incorrectly administered dose; When vaccine was being administered, the needle disconnected from the syringe; A spontaneous report was received from a healthcare professional concerning a 43-year-old female, White, patient that received Moderna's COVID-19 vaccine (mRNA-1273) and when the vaccine was being administered, the needle disconnected from the syringe/device connection issue. This caused some vaccine to end up on the patient's arm and an incorrectly administered dose/incomplete dose administered/exposure via skin contact. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 29 Jan 2021, the patient received their second dose of mRNA-1273 (Lot number: 029L20A) intramuscularly in left deltoid for prophylaxis of COVID-19 infection. On 29 Jan 2021, when the vaccine was being administered, the needle disconnected from the syringe. This caused some vaccine to end up on the patient's arm and an incorrectly administered dose. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the events is not applicable. The outcome for the events was considered resolved on 29 Jan 2021.; Reporter's Comments: This report refers to a case of Product administration error (Incorrect dose administered, Exposure via skin contact , Device connection issue) for mRNA-1273, lot # 029L20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Device connection issue', 'Exposure via skin contact', 'Incorrect dose administered']",1,MODERNA,OT 1048663,FL,,F,"Passed out; Blood pressure dropped; Neck ache; Body ache; Dizziness; Nausea; Vomiting; Severe chills; Injection site swelling; A spontaneous report was received from a consumer, concerning a 86-year-old, female patient, who received Moderna's COVID-19 vaccine and experienced passed out, blood pressure dropped, neck, body ache, dizziness, nausea, vomiting, severe chills and injection site swelling. The patient's medical history was not provided. Concomitant product use was not provided. On 05 Feb 2021 at 10:00 am, prior to the onset of the events, patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 05 Feb 2021, initially patient had injection site swelling. Then 22 hours later on 06 Feb 2021, she passed out, her blood pressure dropped, had nausea, vomiting, severe chills, neck and body ache, and dizziness. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events, passed out, blood pressure dropped, neck, body ache, dizziness, nausea, vomiting, severe chills and injection site swelling were unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Blood pressure decreased', 'Chills', 'Dizziness', 'Loss of consciousness', 'Nausea', 'Neck pain', 'Pain', 'Vaccination site swelling', 'Vomiting']",1,MODERNA,OT 1048664,FL,68.0,F,"Passed out; Felt like two sticks in her stomach; Feeling of a warm flush; Fell on head; Sore arm; A spontaneous report was received from a consumer concerning a 68-years-old, female patient who experienced feeling of a warm flush, sore arm, felt like two sticks in her stomach, passed out and fell on head. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 15 Jan 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 01ZC207] intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient felt like two sticks were in her stomach and then a feeling of a warm flush going through her body. She also had a sore arm. Patient felt like she was going to pass out and did pass out and fell on her head. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The events feeling of a warm flush, sore arm, felt like two sticks in her stomach, passed out and fell on head were considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/15/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Abdominal discomfort', 'Fall', 'Flushing', 'Loss of consciousness', 'Vaccination site pain']",1,MODERNA,OT 1048665,NY,,M,"Died; Internal bleeding and died; A spontaneous report was received from a nurse concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced internal bleeding and died. The patient's medical history was not provided. No concomitant product use was reported. On unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, a nurse reported she read about a doctor who received the COVID-19 vaccine and died 3 days later. She stated she read that the doctor had internal bleeding. It started with bleeding in his hands and feet, then went to his brain and died 3 days later. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, internal bleeding and died, was considered fatal.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Reported Cause(s) of Death: Internal bleeding",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Death', 'Internal haemorrhage']",1,MODERNA,OT 1048666,FL,74.0,F,"Sore arm; Itchy rash on back; Swelling; Red blotches all over her arm; Fever; Worsening rheumatoid arthritis; Worsening fibromyalgia; Flu like symptoms; A spontaneous report (United States) was received from a consumer concerning herself, a 74-year-old, female patient who Moderna's COVID-19 Vaccine (mRNA-1273) and experienced worsening fibromyalgia, worsening rheumatoid arthritis, flu-like symptoms, sore arm, itchy rash on back, fever, swelling and red blotches all over her arm. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011L20A). On 05 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number:031L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 06 Jan 2021, after the first shot of vaccine, the patient experienced worsening fibromyalgia, worsening rheumatoid arthritis like her fingers were hurting so bad that she felt like they were going to fall off and flu like symptoms with fever. On 05 Feb 2021, after the second shot, patient experienced sore arm, swelling, red blotches all over her arm and itchy rash on her back. Treatment for event included acetaminophen and diphenhydramine which didn't seems to help events at all. Action taken with mRNA-1273 in response to the events were unknown. The outcome of the events, worsening fibromyalgia, worsening rheumatoid arthritis, flu-like symptoms, sore arm, itchy rash on back, fever, swelling and red blotches all over her arm were considered unknown at the time of this report.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the onset of the reported events, and the known safety profile of mRNA-1273 a causal relationship cannot be excluded",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Fibromyalgia', 'Influenza like illness', 'Pain in extremity', 'Pyrexia', 'Rash pruritic', 'Rheumatoid arthritis', 'Vaccination site rash', 'Vaccination site swelling']",2,MODERNA,OT 1048667,FL,46.0,F,"Finally urinated and it was dark in color; Induration of erythema about 3 inches; Acute renal failure; Felt so dry and realized I did not urinate; Disoriented; Sustained tachycardia for about 26 hours straight; Couldn't lay on left side; Induration of erythema about 3 inches; chills/rigors; Chills and sweats, back and forth; Severe tremor, rigors/Chills; Temperature was 104.1/ Fever persisted; Significant headache/Worst headache of her life; Body aches; Nausea; Vomiting; A spontaneous report was received from a consumer who is a physician's assistant) concerning 46 year old female patient. Medical history included cystic fibrosis. No relevant concomitant medication was reported. On an unspecified date, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection. On 04Feb2021, the patient received the second dose of mRNA-1273 (lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection. On 05Feb2021, the patient experienced severe tremor, rigors, temperature of 104.1, significant headache (described as worst headache in her life), persistent fever, body aches, nausea vomiting, chills and sweats back and forth. The patient was in bad all day 04Feb2021 (Thursday) through Saturday until 2pm. She felt dry and did not urinate, until after a bag of unspecified intravenous fluids, when she finally urinated in was dark in color (the patient considered herself to have acute renal failure). The patient also experienced sustained tachycardia for 26 hours, was disoriented, had induration of erythema about three inches at the vaccination site, and could not lay on her left side. The patient treated herself with ibuprofen and Tylenol for fever and body aches. The patient reported she was fine on 08Feb2021. Action taken with the mRNA-1273 in response to the events was not reported. The outcome of the events of acute kidney injury, urinary retention, tremor, pyrexia, headache, pain, nausea, vomiting, hyperhidrosis, chromaturia, tachycardia, disorientation, vaccination site induration, vaccination site erythema, hypokinesia, and chills was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events , a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/05/2021,1.0,UNK,,Cystic fibrosis,,,,"['Acute kidney injury', 'Chills', 'Chromaturia', 'Disorientation', 'Headache', 'Hyperhidrosis', 'Hypokinesia', 'Nausea', 'Pain', 'Pyrexia', 'Tachycardia', 'Tremor', 'Urinary retention', 'Vaccination site erythema', 'Vaccination site induration', 'Vomiting']",2,MODERNA,OT 1048668,,,F,"Immune thrombocytopenia; A spontaneous report was received from a consumer concerning a 72-year-old, female patient, who experienced bruises on her arm, legs and blisters that bled inside her mouth and severe immune thrombocytopenia. The patient's medical history was not provided. Concomitant product used was not provided by the reporter. On an unspecified date, one day prior to the onset of events, the patient received their first two planned doses of mRNA-1273 (Batch number: not provided) for the prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced bruises on her arm, legs and blisters that bled inside her mouth. On 19 Jan 2021, the patient was admitted in the hospital with a severe case of immune thrombocytopenia. The patient was given platelet transfusions along with steroids and immunoglobulins. On 02 Feb 2021, the patient's condition slightly improved and was sent home. Treatment for the events included platelet transfusion, steroids and immunoglobulins. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, bruises on her arm, legs and blisters that bled inside her mouth and severe immune thrombocytopenia, were considered resolved on an unspecified date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time.",Not Reported,,Not Reported,Yes,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Immune thrombocytopenia'],1,MODERNA, 1048669,NH,,M,"Hallucinating; A spontaneous report was received from a Physician concerning a male individual (other health care professional and colleague) who received his 2nd dose of Covid-19 vaccine and have experienced hallucinations. The consumer's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, prior to the onset of events, the consumer received his 2nd of two planned doses of covid-19 vaccine for the prophylaxis of Covid-19 infection. According to physician, her colleague started hallucinating after his second shot. It is not known whether the patient had medical intervention or went to ER for treatment. Physician couldn't provide any further information as her head was fuzzy to answer any more questions. Action taken with doses of Moderna Covid-19 vaccine was not applicable as the patient received both the doses. The outcome of the event hallucinations was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history provided.),,,['Hallucination'],2,MODERNA, 1048670,PA,,F,"Possibly injected using 1/2 inch needle; Sore Arm; A spontaneous report was received from a PA concerning a 60 year old, female patient who experienced injection site pain after possible wrong technique in device usage process. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the arm for prophylaxis of COVID-19 infection while using 1/2 inch needle. Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the event, possible wrong technique in device usage process, was considered recovered/resolved on 05 Feb 2021. The outcome of the event, sore arm, was not reported.; Reporter's Comments: This report refers to a case of wrong technique in device usage process for mRNA-1273 (lot unknown) with reported listed non-serious event of vaccination site pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Vaccination site pain', 'Wrong technique in device usage process']",1,MODERNA,OT 1048671,FL,,F,"not injected into the middle of the deltoid, but rather on the side of the arm; sore arm; swollen about 2-3 inch area, circle, red, and warm; Vaccination Site Red; A spontaneous report was received by a consumer regarding herself an 88-year-old female patient who experienced the vaccine not injected into the middle of the deltoid, but rather on the side of the arm/Incorrect route of product, sore arm/vaccination site pain, swollen about 2-3 inch area circle raised, red and warm/vaccination site swelling, and vaccination site red/vaccination site erythema. The patient's medical history was not provided. No concomitant medications provided. The patient received the first of two planned doses of mRNA-1273 (Batch number 030L20A) injected into the side of the left arm for prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient received her vaccine, but noted that it was not given in the middle of the deltoid, but rather on the side of the arm. She also had a sore arm, swelling reported as about a 2-3 inch circle which was red and warm. Treatment information was not provided. Patient consented to be contacted. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, vaccine not injected into the middle of the deltoid, but rather in the side of the arm, sore arm, and a 2-3 inch circle that is raised, red and warm, was considered resolved.; Reporter's Comments: The events developed on same day after first dose of mRNA-1372. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,02/05/2021,8.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Incorrect route of product administration', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",1,MODERNA,OT 1048672,,89.0,M,"Pass away; Got COVID; A spontaneous report was received on from a consumer, concerning an 87-year-old male patient, who received Moderna's COVID-19 (mRNA 1273) vaccine and experienced pass away (death) and COVID (COVID-19). The patient's medical history was not provided. No relevant concomitant medications were reported. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 injection for the prophylaxis of COVID-19 infection. Two days after mRNA-1273 injection, the patient's daughter was diagnosed with COVID-19 infection. The daughter states that her mother also got infected with COVID. On an unknown date, the patient got COVID. It was reported that he passed away. Treatment for the event was not provided. The cause of death was not provided. The plans for an autopsy were not provided. .; Reporter's Comments: Although the onset date of COVID-19 and the fatal outcome is lacking, Based on the natural history of COVID-19, the reported event, it is assessed as unlikely related with mRNA-1273. The actual cause of death cannot be ascertained but assessed as not related and most likely due to the COVID-19 infection.",Yes,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,,,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No adverse event, Continue: [UNK], Comment: No reported medical history.",,,"['COVID-19', 'Death']",1,MODERNA,OT 1048673,CA,,M,"some of the vaccine spilled from the syringe; pain at the injection site; This spontaneous report was received from consumer on 04-feb-2021, concerning a 84 year old male patient who was administered Moderna COVID-19 vaccine ( mRNA-1273). The patient experienced pain at the injection site and reported some of the vaccine spilled from the syringe down his arm. The patient's medical history and Concomitant medication was not provided.. The patient received suspect product mRNA-1273 on 04-feb-2021, prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:029L20A)intramuscularly on the right arm for prophylaxis of COVID-19 infection On 11-FEB-2021 to complete his adverse reaction form and to update Moderna on how he is going to proceed. Patient will get his second injection and will have antibodies after the second Moderna Covid-19 at the direction of his Physician Action taken with the second dose of mRNA-1273 in response to the event was not reported; Reporter's Comments: This case report concerns a 84 year old male patient who was administered mRNA-1273 vaccine Lot# 029L20A and experienced pain at the injection site and reported some of the vaccine spilled from the syringe down his arm. (incomplete dose administered). The event of pain at the injection site is consistent with the known safety profile of mRNA-1273 and temporarily associated with the product use and a causal association cannot be excluded. The event of incomplete dose administered is assessed as not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Underdose', 'Vaccination site pain']",1,MODERNA,OT 1048674,TX,66.0,F,"Possible kidney infection; Possible bladder infection; A spontaneous report received from a Consumer concerning, 66-year-old female patient who received first dose of the Moderna COVID-19 vaccine and experienced possible kidney infection and possible bladder infection (Cystitis) The patient's medical history was not included. Patient's concomitant medication was not included. On 27JAN2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Patient stated she received her first dose of the Moderna COVID-19 vaccine on 27Jan2021. Patient stated on 30Jan2021, she started to smell an odor and believes that she has a bladder or kidney infection. Patient stated that her doctor cannot see her for several days. Patient would like to have the doctor call in a ZPack or other antibiotic but wants to know if this will interfere with the Moderna COVID-19 vaccine. Patient stated that she does not have a fever. Treatment information was not provided/ unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the events was unknown/not reported.; Reporter's Comments: This report concerns a 66--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # not provided, and experienced possible bladder and kidney infection. Very limited information regarding this event has been provided at this time. Further information has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/30/2021,3.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Cystitis', 'Kidney infection']",1,MODERNA,OT 1048675,OH,56.0,F,"Chest tightening; moist non productive cough; tightening of the throat; facial flushing; hot flashes; This is a spontaneous report from a contactable nurse. A 56-year-old female patient received second dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: EL3302) via intramuscular, on right arm on 02Feb2021, 10.30 at single dose for COVID-19 immunization. The medical history included allergies to bees and nickel, GERD (Gastro-oesophageal reflux disease). The concomitant medication included diphenhydramine hydrochloride, paracetamol (TYLENOL PM) on an unknown date in 2021. The patient previously received historical vaccine, first dose of bnt162b2 (Brand: Pfizer, Lot number: EL0140) via intramuscularly on left arm at 9.30 on 12Jan2021 for COVID-19 immunization. It was reported that at 10.45 on 02Feb2021, the patient experienced chest tightening, moist non-productive cough, tightening of the throat, facial flushing, hot flashes. The patient was not pregnant at the time of vaccination. The patient received most recent COVID-19 vaccine at nursing home/senior living facility. The patient didn't receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient received Tylenol Pm within 2 weeks of vaccination. The patient visited emergency room for the events. Therapeutic measures were taken because of events via oral and subcutaneous. The patient had not diagnosed with COVID-19 prior to the vaccination and since the vaccination. The outcome of the events was recovered on an unknown date in 2021.; Sender's Comments: The association between the events chest tightening, moist non-productive cough, tightening of the throat, facial flushing, hot flashes with BNT162B2 use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,SEN,TYLENOL PM,,Medical History/Concurrent Conditions: Allergic reaction to bee sting (allergies: bees); GERD,,,"['Chest discomfort', 'Cough', 'Flushing', 'Hot flush', 'Throat tightness']",2,PFIZER\BIONTECH,OT 1048676,NE,72.0,F,"Severe eye pain evening after; drooping eyelid and eyeball on left side; This is a spontaneous report from a contactable consumer (patient herself). A 72-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number was not reported, Pfizer NTEC), via an unspecified route of administration in left arm on 05Feb2021 12:00 pm at single dose for COVID-19 immunization. The patient's medical history included thyroid issue, elevated cholesterol. Concomitant medications included ospemifene (OSPHENA), levothyroxine, meloxicam and ezetimibe. The patient was not diagnosed with COVID-19 prior to vaccination. The patient have not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe eye pain and drooping eyelid and eyeball on left side evening after (05Feb2021 20:00). Next day and still happening, drooping eyelid and eyeball on left side. The patient did not receive any treatment for the adverse events. The events were considered as non-serious by the consumer. The outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,PUB,OSPHENA; LEVOTHYROXINE; MELOXICAM; EZETIMIBE,,Medical History/Concurrent Conditions: Blood cholesterol increased; Thyroid disorder,,,"['Eye pain', 'Eyelid ptosis']",1,PFIZER\BIONTECH, 1048677,MI,58.0,F,"shingles; Bump on nose; It is painful; broke out in rash/rash under right eye; pretty sick; This is a spontaneous report from a contactable nurse (the patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left upper arm on 19Jan2021 at 11:15 to 11:30 (at the age of 58-years-old) as a single dose for Covid-19 immunization. Medical history included COVID-19 in Mar2020 and was reported as recovering (ongoing). The patient's concomitant medications were reported and none. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Feb2021, the patient experienced a bump on her nose and later got a rash under the right eye and broke out in a rash; on 08Feb2021, the patient was diagnosed with shingles; on an unknown date in Feb2021 she experienced she was pretty sick now; not feeling well and it was painful. The patient went to the emergency room about 3:40am on 08Feb2021. The events were considered serious per disabling since she was not able to return to work until blisters were crusted over. Has missed a couple days of work. Her only concern was that it was not in her eye and she was good. Treatment was given for the shingles which included Acyclovir. The clinical outcome of the events herpes zoster, rash, illness, skin disorder and pain was not recovered. The reporter stated she was supposed to get her second dose but cannot now. The reported considered the events herpes zoster, rash, illness, skin disorder and pain related to BNT162B2. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/19/2021,02/01/2021,13.0,PHM,,COVID-19 (Recovering),,,,"['Herpes zoster', 'Illness', 'Pain', 'Rash', 'Skin disorder']",1,PFIZER\BIONTECH, 1048678,NM,72.0,M,"polymyalgia rheumatica; mild headache; upper arm and hip flexor ache; upper arm and hip flexor ache; injection site induration; left arm muscle ache; malaise; This is a spontaneous report from a contactable physician reporting for self. A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #EL3249), via an unspecified route of administration on 23Jan2021 12:00 at single dose for covid-19 immunisation. Medical history included hypertension, arthritis. Concomitant medication included losartan, hctz, dabigatran. On 23Jan2021, patient experienced injection site induration, left arm muscle ache, malaise; on 30Jan2021, patient experienced mild headache, upper arm and hip flexor ache relieved by aspirin or NSAIDs for three days, and polymyalgia rheumatica. Consistent with polymyalgia rheumatica. Still the same symptoms at day 12 the milder. Outcome of events was recovering.; Sender's Comments: The serious event reported as polymyalgia rheumatica is deemed as possibly related to BNT162B2 vaccine administration based on the plausible drug-event temporal association The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/23/2021,0.0,PVT,LOSARTAN; HCTZ; DABIGATRAN,,Medical History/Concurrent Conditions: Arthritis; Hypertension,,,"['Arthralgia', 'Headache', 'Malaise', 'Myalgia', 'Pain in extremity', 'Polymyalgia rheumatica', 'Vaccination site induration']",1,PFIZER\BIONTECH, 1048679,MN,78.0,F,"Double vision; the way she talked she kind of had slurred speech; mouth was dry; she had Bell's Palsy/ Droop in her lip/mouth; her eye was still watering; puffiness around her eye; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of bnt162b2 (manufacture unknown, Lot Number: 9264), intramuscularly in left arm on 29Jan2021 14:55 at 0.3 ml, single for COVID-19 immunization. Medical history included non-hodgkin's lymphoma from Jul2019 and ongoing (The first time she was diagnosed was Jul2019. She then went into remission and then got the cancer back, she doesn't know when. She knows they started treating it as the cancer had returned in Aug 2020), watering eyes from an unknown date and unknown if ongoing (Her eye was watering before the injection. She knows her eye was watering before she received the vaccine), chemotherapy from an unknown date and unknown if ongoing (she is a cancer patient on chemotherapy), fever blister from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced she had bell's palsy and she does not know if she got this from the covid shot or not but she still has the droopy lip which apparently that can last a while. on 02Feb2021, droop in her lip/mouth on 02Feb2021, her eye was still watering on 02Feb2021, there was a little puffing around the eye/ puffiness around her eye on 02Feb2021, double vision on an unspecified date, the way she talked she kind of had slurred speech on an unspecified date. Caller was calling about the Pfizer COVID 19 vaccine. She said on Friday 29Jan2021 she had the first shot at about 12:30. Her eye started watering in the morning Thursday the day before and she maybe assumed she was getting a cold in her eye but it was really runny and she got the shot. She was a cancer patient on chemo and she went to the doctor because she was supposed to get her chemo. That Tuesday morning she had a droopy lip on the right side and her eye was still watering, there was a little puffing around the eye and the way she talked she kind of had slurred speech so she thought stroke but she was going to get her chemo in an hour or 2 so she when they checked her she told them what happened, she was seeing the PA that day so she left and came back 10 minutes later and said she had talked to the doctor, they were not going to give chemo today and told her she had Bell's Palsy and she does not know if she got this from the COVID shot or not but she still has the droopy lip which apparently that can last a while. This was her first shot so as a cancer patient on chemo should be getting the second shot 21Feb. She was concerned about taking that when she already has Bell's Palsy now, what else would it cause and then if she does not get it would she be 50 % protected. The doctor seemed to say she thought it was from the vaccine, but caller does not know because the eye watering began the day or 2 prior to getting the vaccine. Product details: She does not have the vaccine card right with her and she was using a walker to get up and down and so she was not able to provide NDC lot expiration right now. It would be available if needed at a later time. Indication: doctor said she should have it because she has no immune system. They don't know what to do they are just following what they told her and they were scared to death. The caller states she was a cancer patient on chemotherapy. She received her first Pfizer COVID-19 injection on Friday, 29Jan2021. Prior to the vaccine, her eye had been watering Thursday or Friday morning before she had shot, it was just her right eye. On Tuesday, 02Feb2021, she developed a droop in her mouth and puffiness around her eye and so forth. Caller clarified it was just on the right side and with her right eye. She also has double vision in her right eye. She got up in the morning on 02Feb2021, and her husband was in the other room and told her that she sounded funny. She explained to her husband her mouth was dry and she was kind of slurring her speech. Her husband came into the room she was in and said, ""huh, your lip was drooping"". Since it was in the morning and she had no other symptoms besides the talking funny and the puffiness around her eye, she didn't take it as a stroke. She figured she would just until she went to her chemotherapy appointment she had the same day, 02Feb2021. She went into her appointment and showed the person and gave her information on what happened. The person wanted an MRI of the brain to make sure she didn't have cancer there or cancer anywhere else up in that area and also that she didn't have a stroke. She confirms the MRI was fine, both were negative for any signs of this. She was told she developed bell's palsy. She has a drooping lip. The caller was concerned about her second shot. She wants to know should she getting the second vaccine, because the person at the (institution name) office (where she receives her chemotherapy) believes the bell's palsy came from the COVID-19 vaccine. She was supposed to have chemotherapy that day (02Feb2021), but they wouldn't give it to her then, but she did have it done yesterday. Caller explains she has no NDC, Lot number or expiration date for the chemotherapy she receives. She isn't given any stuff with any numbers and she gets numerous medications. Patient's Medical History (including any illness at time of vaccination): Her eye was watering before the injection. She knows her eye was watering before she received the vaccine because as she was sitting waiting to receive her injection, she remembers wiping her eye and thinking to herself, ""I wish this eye would quit watering"". Caller states she had a fever blister, but she was not quite sure about when this appeared. She doesn't know if she had developed the fever blister before or the next day after receiving the vaccine, she was not quite sure. The any events were not required a visit to Emergency Room. She went to the Oncology Office for her chemotherapy appointment. No Prior Vaccinations (within 4 weeks). Caller had the MRI (magnetic resonance imaging) on 02Feb2021 showed she didn't have a stroke and no cancer of the brain. The patient underwent lab tests and procedures which included magnetic resonance imaging: negative on 02Feb2021 Negative for stroke and/or cancer. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,02/02/2021,4.0,UNK,,Lymphoma (non-Hodgkin's) (The first time she was diagnosed was Jul2019.),Medical History/Concurrent Conditions: Chemotherapy (The caller states she is a cancer patient on chemotherapy); Fever blister; Watering eyes (Her eye was watering before the injection.),,,"['Diplopia', 'Dry mouth', 'Dysarthria', 'Eye oedema', 'Facial paralysis', 'Lacrimation increased', 'Magnetic resonance imaging']",1,PFIZER\BIONTECH,OT 1048680,,78.0,F,"Acute ischemic stroke on 02Jan2021; This is a spontaneous report from a contactable Healthcare Professional. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 at single dose for COVID-19 immunisation at the age of 78-year-old. Medical history and concomitant medications were unknown. The patient was not pregnant at the time of vaccination. Patient had Acute ischemic stroke on 02Jan2021; the patient was hospitalized, and she was treated for the event. On 01Feb2021, nasal swab resulted negative. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was recovering from the event. Patient has not tested positive for COVID-19 since having the vaccine. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information there is no evidence or argument to suggest a causal relationship between the reported event of ischemic stroke and BNT162B2 administration. Event occurred prior to vaccination.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/28/2021,02/01/2021,4.0,UNK,,,,,,"['Ischaemic stroke', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1048681,UT,,F,She received her 1st shot of vaccine a month ago and was diagnosed with crohn's disease after; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received BNT162B2 first dose on unspecified date in Jan2021 at single dose for covid-19 immunization. Medical history and concomitant medications were not reported. She received her 1st shot of vaccine a month ago and was diagnosed with crohn's disease after. She just took steroids 5 mg. Her 2nd shot of our vaccine is scheduled this Saturday and she is asking if it's okay. The outcome of the event was unknown. Information about lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,,,UNK,,,,,,"[""Crohn's disease""]",1,PFIZER\BIONTECH, 1048682,CA,50.0,F,"Arm burning from the inside out from injection site right after injection; headache; tingling hand and feet; swelling hands feet and face; swelling face; flushed; red all over wheel down to ED; lump in throat; Low blood pressure; high resting heart rate; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: e10140), via an unspecified route of administration at the left arm on 11Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included psoriatic arthritis, and allergies to shellfish, sulfa, bees, and, kiwi. The patient was not pregnant at the time of vaccination. Concomitant medication included naproxen sodium (ALEVE) and estradiol (ESTROGEN). The patient previously took naproxen (NAPROSYN) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm burning from the inside out from injection site right after injection on 11Jan2021 9:15. Seconds later the patient experienced headache, lump in throat, tingling hand and feet, swelling hands, feet, and face, flushed, red all over wheel down to Ed, low blood pressure, and high resting heart rate all on 11Jan2021. The events resulted in emergency room/department or urgent care. Treatment was received for the all the events reported as IV with added therapy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect product administration to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,PVT,ALEVE; ESTROGEN,,Medical History/Concurrent Conditions: Fruit allergy; Insect sting allergy; Psoriatic arthritis; Shellfish allergy; Sulfonamide allergy (sulfa allergy),,,"['Blood pressure measurement', 'Erythema', 'Flushing', 'Headache', 'Heart rate', 'Heart rate increased', 'Hypotension', 'Paraesthesia', 'Peripheral swelling', 'Pharyngeal mass', 'Swelling face', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1048683,VA,82.0,M,"passed out; light headed; This is a spontaneous report from a contactable consumer (patient's daughter). An 82-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK4176), via an unspecified route of administration on 25Jan2021 09:50 at single dose for covid-19 immunization. Medical history included visual problem. The patient's concomitant medications were not reported. The patient experienced passed out on 02Feb2021 and light headed in 2021. Clinical course: Consumer was calling regarding her dad who got the Pfizer COVID-19 vaccine. She said her dad had an event and she took him to his cardiologist who checked him out and suggest they call about it. She said that her dad passed out a week and a day after getting the vaccine and had been light headed. She said she was concerned that the second dose of the vaccine was supposed to be worse for effects, and she knew he was supposed to get it, but she wasn't sure that he should. She said her dad would say to call his daughter, because he had a visual problem, which he had since before the first dose of the COVID-19 vaccine. Caller said that NDC/EXP were not provided on the handwritten card. She said it said he got his first dose 25Jan2021. She said that the report she filed online asked what time he got the vaccine dose, and she put 09:45AM since it would not let her put 09:50AM, it was really at 09:50AM. Outcome of events were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,02/02/2021,8.0,UNK,,,Medical History/Concurrent Conditions: Vision abnormal,,,"['Dizziness', 'Loss of consciousness']",1,PFIZER\BIONTECH, 1048684,,,U,"The covid vaccine that has caused severe abdominal pain/severe pains; This is a spontaneous report from a contactable consumer (patient). An unknown age and gender patient received BNT162B2 (Batch/lot number: Unknown) on 03Feb2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. It was reported that the covid vaccine that has caused severe abdominal pain (hospitalization). I round up in hospital and yesterday was severe pains and they ruled any life threatening issue out, through a CAT scan, blood work and urine specimen, so I just basically wanted to know if anybody else had the problems with the abdominal pain. Outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/03/2021,,,UNK,,,,,,"['Abdominal pain', 'Blood test', 'Computerised tomogram', 'Urine analysis']",UNK,PFIZER\BIONTECH, 1048685,,,U,"Bell's palsy; This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced bell's palsy 2 weeks after receiving Pfizer COVID vaccine on an unspecified date with outcome of unknown. Event took place after use of product. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event Bell's palsy cannot be completely excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Facial paralysis'],UNK,PFIZER\BIONTECH, 1048686,CA,,F,"died just 10 days after being given the vaccine/ put sepsis on her medical records; This is a spontaneous report from a contactable consumer report for Aunt. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization. Medical history included schizophrenia and depression. The patient's concomitant medications were not reported. Consumer's aunt (patient) was housed in a facility. She was being treated for schizophrenia and depression. This was one of the facilities that chose to house Covid patients during the pandemic. Many of the patients here contracted covid19 during this time and they had to do a full facility lockdown and quarantine. The patient tested positive in Nov2020 and was quarantined to her room for 10 days. 3 weeks ago (in Jan2021), she received the Pfizer vaccine. Consumer's family was not given notice of this and we are sad to report that she died just 10 days after being given the vaccine. They put sepsis on her medical records and have not connected this to the vaccine. Consumer stated aunt was just 59 yrs old, though she was being treated for her mental illness, she was physically healthy. Consumer's family gravely concerned that this facility neglected her health by administering the vaccine without considering possible reactions from the medication she was taking, or the fact she had Covid just months prior. Patient died on an unspecified date. it was unknown if an autopsy performed. Information on Lot/Batch number has been requested.; Reported Cause(s) of Death: died just 10 days after being given the vaccine/ put sepsis on her medical records",Yes,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,,,UNK,,,Medical History/Concurrent Conditions: Depression; Schizophrenia,,,"['SARS-CoV-2 antibody test', 'Sepsis']",1,PFIZER\BIONTECH, 1048688,NY,94.0,F,"My mother had a stroke on 28Jan2021 sometime after 9:30 AM the morning after getting the first dose of the Pfizer Covid vaccine; Cerebral infarction; This is a spontaneous report from a contactable consumer (reporting for mother). A 94-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown as not available or provided to reporter at the time of report completion) via an unspecified route of administration on 27Jan2021 in right arm at single dose for COVID-19 immunization. Medical history included coronary artery disease and hypertension. There were no concomitant medications. The patient was not pregnant. No other vaccine was received in four weeks. The patient did not have covid prior vaccination and not have covid tested post vaccination. The patient had a stroke on 28Jan2021 sometime after 9:30 AM the morning after getting the first dose of the Pfizer Covid vaccine and was hospitalized due to stroke for 6 days from Jan2021. The patient then experienced cerebral infarction in 2021 and died due to it on 04Feb2021. Treatment received for events stroke and cerebral infarction included tPA injection. The outcome of events stroke and cerebral infarction was fatal. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cerebral infarction",Yes,02/04/2021,Not Reported,Yes,6.0,Not Reported,N,01/27/2021,01/28/2021,1.0,SEN,,,Medical History/Concurrent Conditions: Coronary artery disease; Hypertension,,,"['Cerebral infarction', 'Cerebrovascular accident']",1,PFIZER\BIONTECH, 1048689,FL,46.0,M,"Atrial fibrillation; ventricular arrythmias; mild fever; Cough; Short of breath; Fatigue; Tachycardia; This is a spontaneous report from a contactable consumer and a contactable nurse. This 46-year-old male patient received the second dose of BNT162B2 (PFIZER BIOTHCH MRNA VACCINE, LOT: EL3302), via an unspecified route of administration on 25Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included lone atrial fibrillation, IgA nephropathy. No Covid prior vaccination. No known allergy. Concomitant medication included metoprolol, lisinopril and acetylsalicylic acid (BABY ASPIRIN). The patient did not received other vaccine in four weeks. The patient previously received the first dose of Pfizer BNT162B2 (Lot number=ZK9231) on 04Jan2021 on right arm for COVID-19 immunization. On 26Jan2021, after 2nd vaccine, the patient had mild fever, cough and short of breath. He went to urgent care, chest X-ray clear, Covid test negative. Mild fever subsided after one day, but short of breath and cough continued. Covid test again negative. PCP prescribed azithromycin (Zpack) and methylprednisolone sodium succinate (SOLUMEDROL). Short of breath and cough continue and amoxicillin / clavulanic acid (AUGMENTIN) and prednisone prescribed. Short of breath, cough, and fatigue. Reported to ER on 15Feb2021. The patient had atrial fibrillation, tachycardia, ventricular arrythmias and were treated and admitted for further evaluation. Covid test collected again-negative. Currently in the hospital at time of this report. All of the events were on 26Jan2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 3 days, Life threatening illness (immediate risk of death from the event). Treatment included diltiazem hydrochloride (CARDIAZEM), enoxaparin sodium (LOVENOX), furosemide (LASIX). Covid test type post vaccination included nasal swab on 26Jan2021 with result negative, nasal swab on15Feb2021 with result negative, blood test on in Feb2021 with result negative. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events pyrexia, cough, fatigue and short of breath. The events atrial fibrillation, ventricular arrhythmia and tachycardia are considered not related to BNT162B2, but rather due to underlying medical conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,3.0,Not Reported,N,01/25/2021,01/26/2021,1.0,PUB,METOPROLOL; LISINOPRIL; BABY ASPIRIN,,Medical History/Concurrent Conditions: Atrial fibrillation; IgA nephropathy,,,"['Atrial fibrillation', 'Chest X-ray', 'Cough', 'Dyspnoea', 'Fatigue', 'Pyrexia', 'SARS-CoV-2 test', 'Tachycardia', 'Ventricular arrhythmia']",2,PFIZER\BIONTECH, 1048690,IL,89.0,F,"presumed cardiac failure; This is a spontaneous report from a contactable nurse. An 89-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular at arm left on 10Feb2021 (at the age of 89 years) at single dose for COVID-19 immunization. The patient medical history included congestive heart failure, coronary artery disease, hypertension, hyperlipidemia, osteoarthritis, presence of prosthetic heart valve and allergies, all from an unknown date and unknown if ongoing. The patient's concomitant medication included amlodipine besilate/benazepril hydrochloride, amlodipine, acetylsalicylic acid (ASPIRIN E.C.), atorvastatin, benazepril, carvedilol, ubidecarenone (COQ10), furosemide, acetaminophen and potassium chloride. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular at arm left on 20Jan2021 at single dose for COVID-19 immunization. The patient experienced presumed cardiac failure on 12Feb2021 at 03:30 with fatal outcome. The patient died on 12Feb2021. An autopsy was not performed.; Sender's Comments: Based on the current available information, the event Cardiac failure is most likely related to an intercurrent or underlying condition which is not related to the suspected drug BNT162B2. The patient medical history of congestive heart failure, coronary artery disease, hypertension, and hyperlipidemia provide plausible explanations for the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: presumed cardiac failure",Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/12/2021,2.0,SEN,AMLODIPINE BENAZEPRIL; AMLODIPINE; ASPIRIN (E.C.); ATORVASTATIN; BENAZEPRIL; CARVEDILOL; COQ10 [UBIDECARENONE]; FUROSEMIDE; ACETAMINOPHEN; POTASSIUM CHLORIDE,,Medical History/Concurrent Conditions: Allergy; Congestive heart failure; Coronary artery disease; Hyperlipidemia; Hypertension; Osteoarthritis; Prosthetic cardiac valve malfunction,,,['Cardiac failure'],2,PFIZER\BIONTECH,OT 1048691,,,M,"White blood cells went up greatly; Blood clots in his legs; oxygen went down/oxygen levels went down; This is a spontaneous report from a contactable consumer (patient's daughter). A male patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included he had Leukemia and was on treatment. The patient's concomitant medications were not reported. The patient took first dose bnt162b2 for COVID-19 immunization. Caller says that her father got his second COVID vaccine from Pfizer. He wound up in the hospital 3 days later. His white blood cells went up greatly and he has blood clots in his legs. They do not know what is happening. They are very worried about him. He is getting a bone marrow test today (08Feb2021). His oxygen went down yesterday (07Feb2021) and is now on oxygen. She is freaking out about it. She really thinks it has to do with vaccine. It was asked if there was any information on other people with Leukemia getting the vaccine. If what research there was on this. They need all the help and information they can get. Every minute counts as everything getting worse. He is now on oxygen as his oxygen levels went down. He is getting worse every hour. The patient underwent lab tests and procedures which included oxygen saturation: his oxygen went down yesterday/oxygen levels went down on 07Feb2021, white blood cell count: his white blood cells went up greatly on an unknown date, biopsy bone marrow: unknown results on 08Feb2021. Reporter seriousness for White blood cells went and Blood clots in his legs up greatly was hospitalization. Therapeutic measures were taken as a result of oxygen went down. The outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,,02/07/2021,,UNK,,,Medical History/Concurrent Conditions: Leukemia (is on treatment),,,"['Biopsy bone marrow', 'Oxygen saturation', 'Oxygen saturation decreased', 'Thrombosis', 'White blood cell count', 'White blood cell count increased']",2,PFIZER\BIONTECH, 1048708,FL,,F,"Brain hemorrhage; Allergic reaction; Face, eyes, ears, lips and hands were swollen; Face, eyes, ears, lips and hands were swollen; Face, eyes, ears, lips and hands were swollen; Face, eyes, ears, lips and hands were swollen; Face, eyes, ears, lips and hands were swollen; Hands were itching; A spontaneous report (United States) was received from a consumer a 74-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced brain hemorrhage, allergic reaction, face, eyes, ears, lips and hands were swollen, and hands were itching. The patient's medical history, as provided by the reporter included allergy to gadavist and tromethamine. The concomitant medications reported included diltiazem, atorvastatin calcium, ezetimibe and hydrochlorothiazide for unspecified indications. On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011LZ0A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 18 Jan 2021, the patient experienced brain hemorrhage, allergic reaction, face, eyes, ears, lips and hands were swollen, lips looked as an overdose of botox and hands were itching. The patient was taken to the emergency room (ER) and treated with intravenous diphenhydramine and steroids. It was stated that the swelling lasted 36 hours and the patient was prescribed prednisone to treat symptoms after leaving ER. Action taken with mRNA-1273 in response to the events was not provided. However, the healthcare professional recommended patient to cease with the vaccination series due to probability of the patient being allergic to tromethamine. The events, allergic reaction, face, eyes, ears, lips and hands were swollen, and hands were itching, were considered resolved on 20 Jan 2021. The outcome for the event, brain hemorrhage, was unknown.; Reporter's Comments: This case concerns a 74 year old, female patient, with a medical history of allergy to gadavist and tromethamine, who experienced a serious unexpected event of Cerebral hemorrhage, hypersensitivity after receiving first dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/15/2021,01/18/2021,3.0,UNK,DILTIAZEM; STATIN EZ; DIURETIC [HYDROCHLOROTHIAZIDE],Drug allergy (allergy to Gadavist and tromethamine.),,,,"['Cerebral haemorrhage', 'Ear swelling', 'Eye swelling', 'Hypersensitivity', 'Lip swelling', 'Peripheral swelling', 'Pruritus', 'Swelling face']",1,MODERNA, 1048709,,39.0,F,"Upper arm muscle pain for two days following vaccine at injection site, after 2nd day all pain was gone. Day 8 Arm muscle pain returned for an additional 2 days. Red line under injection site - after 2 days pain was gone. No treatment taken",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/11/2021,1.0,MIL,,,,,,"['Injection site erythema', 'Injection site pain']",1,MODERNA,SYR 1048710,NC,38.0,F,"Injection on Friday - on Saturday: Pain in arm of injection, blotchy red patches going down arm of injection, extreme joint pain, headache, fever, chills, extreme fatigue. Sunday: arm continues splotchy red, headache, chills, fever, extreme fatigue. Monday: nausea, headache, chills, extreme fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,UNK,"Synthroid, Zoloft, omepraze, lisinopril, vitamin d, metformin",None,Hashimotos Thyroiditis,,Morphine,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Rash macular']",2,MODERNA,SYR 1048711,MA,26.0,F,"Warm to touch, red, tender, febrile (Low trade). Remains 3 days s/p completing series",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,WRK,"Sprintc , vitamin d, vitamin c, Azo probiotic",None,None,,None,"['Erythema', 'Pyrexia', 'Skin warm', 'Tenderness']",UNK,MODERNA,SYR 1048712,KY,36.0,M,Red rash around injection site that was warm to touch Complained of headaches and cramps in calves. Resolved in 2 days without treatment.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/16/2021,11.0,UNK,men's once a day vitamin,none,none,,none,"['Headache', 'Injection site erythema', 'Injection site rash', 'Injection site warmth', 'Muscle spasms']",1,MODERNA,IM 1048713,MD,79.0,F,"Day 1 Rapid heart rate, Fatigue, chills, slight temp, Slept off and on 24 hrs thru Day 2 Day 3 Red rash over both arm pitts, below breasts, upper thighs, Rapid heart pulse, irregular pulse, called and visited Cardiology Clinic for Ekg confirmed PVCs Day 4 Light headed, dizziness affecting gait, forced lying down , general brain fog, rash continued, shortness of breath, rapid heart rate, went to ER, saw nurse for Ekg, blood work, blood pressure, Tylenol 100mg 3x a day Day 5",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/17/2021,0.0,PVT,"Levothyroxin, Eloquis, Asperin, Metoprolal, Crestor, Vagifem, Zolpidem, Align, VitB12 1000mg",None,"Heart disease, High Cholestoral, Hypothyroid",,Sulfa,"['Blood test', 'Chills', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Fatigue', 'Feeling abnormal', 'Gait disturbance', 'Heart rate increased', 'Heart rate irregular', 'Pyrexia', 'Rash', 'Rash erythematous', 'Ventricular extrasystoles']",UNK,MODERNA, 1048714,NY,40.0,F,"Hot, itchy, painful circular rash at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/14/2021,02/21/2021,7.0,OTH,"Zyrtec, oamperazole, daily vitamin",,,,"Sulfur, pork","['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,MODERNA,SYR 1048715,IN,32.0,M,"first rash, then large hardened red area with a lesion-looking red mark, all in all approximately 5"" diameter",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/22/2021,11.0,OTH,"Depakote, Zyrtek, Magnesium, Calcium, Mirilax",none,"Autism, Cerebral Palsy, seizure disorder, repaired cardiac birth defect",,Codeine,"['Erythema', 'Induration', 'Rash', 'Skin lesion']",1,MODERNA,IM 1048716,FL,68.0,F,"Pt. left tent 13 at 8:20 am. At observation site at 8:30 am, pt. was complaining of tingling lips and feeling like blood pressure was high. Paramedics assessed vitals 160/90. Pt. was monitored until symptoms subsised. Paramedics released to leave at 8:55 am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,UNK,Amlodopine,,"DM, HTN",,"Codeine, sulfa","['Blood pressure measurement', 'Hypertension', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 1048717,OH,69.0,F,Hard area and raised red itchy rash the size of a dollar bill,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PHM,Synthroud VITAMIN D NEXIUM PEPCID,None,HIATAL HERNIA GASTRITIS,,None,"['Induration', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",UNK,MODERNA,IM 1048718,ME,77.0,F,"Seven days after first shot, the area of my upper arm under the vaccination site became quite itchy and a bit red and swollen. Hydrocortizone cream stops the itchiness. Still swollen but it's not a problem",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/22/2021,7.0,PHM,none,none,none,,none,"['Erythema', 'Pruritus', 'Swelling']",2,MODERNA,SYR 1048719,MA,40.0,F,Systemic: Exhaustion / Lethargy-Medium,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,SEN,,,,,,"['Fatigue', 'Lethargy']",1,PFIZER\BIONTECH,IM 1048720,CA,90.0,F,Error: Wrong Dose of Vaccine - Too High,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,SEN,,,,,,['Incorrect dose administered'],3,PFIZER\BIONTECH,IM 1048721,NJ,38.0,F,"Redness, swelling, itchy at injection site like a bullseye",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/15/2021,02/23/2021,8.0,PVT,None,No,No,,No,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 1048722,VA,73.0,F,Error: Infection / Cellulitis (diagnosed by MD),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,PHM,,,,,,"['Cellulitis', 'Infection']",1,MODERNA,IM 1048723,SC,21.0,M,Error: Booster Given Too Early,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,SEN,,,,,,['Inappropriate schedule of product administration'],2,MODERNA,SYR 1048724,SC,51.0,F,Error: Booster Given Too Early,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,SEN,,,,,,['Inappropriate schedule of product administration'],2,MODERNA,SYR 1048725,MI,59.0,M,Error: Booster Given Too Early,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,SEN,,,,,,['Inappropriate schedule of product administration'],2,MODERNA,IM 1048726,IA,71.0,M,"chills, body aches and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,OTH,None,None,None,,None,"['Chills', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 1048727,GA,43.0,M,"Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Hypertension-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PHM,,,,,,"['Eye swelling', 'Hypertension', 'Mouth swelling', 'Paraesthesia', 'Swelling face', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 1048728,IA,38.0,F,Rash around injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/15/2021,02/23/2021,8.0,UNK,Multivitamin Claritin,None,Celiac disease,,Egg sensitivity Seasonal allergies,['Injection site rash'],1,MODERNA,SYR 1048729,VA,24.0,F,"0715: pt c/o dizziness, ""can't see,"" ""fuzzy"" post 2nd dose of Pfizer COVID-19 vaccine. pt a&ox3, pale, and diaphoretic. VS 65/39, HR 51, RR 16, SPO2 99 on RA, T 98.4. laid patient on the ground with bilateral extremities above level of the heart. 0720: VS BP 97/53, HR 66, RR 16, SPO2 98 on RA. pt states she feels better. CODE BLUE team arrived at 0723. Blood glucose = 97. pt refused transfer to the ED for further evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,MIL,,,,,,"['Blood pressure abnormal', 'Dizziness', 'Heart rate decreased', 'Hyperhidrosis', 'Pallor', 'Vision blurred']",2,PFIZER\BIONTECH,IM 1048731,CT,66.0,F,"11 days post-vaccine (on the morning of 2/22), I woke to find that the area surrounding the injection site in my left arm was a little bit red and sore. By the end of the day, the soreness in my arm radiated up into the left side of my neck. I applied a heating pad, took a warm bath and went to bed early. This morning, my neck is a little better but the arm is more sore and the red area has gotten larger and is swollen. The pain med-to-mild and does not restrict range of motion or use of my arm. No distinct pattern or broken skin.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/22/2021,11.0,OTH,"Metformin, mucinex, Vitamin D, Vitamin B12, Magnesium, 81 mg aspirin",None,"Type 2 Diabetes, nasal allergy",,None,"['Condition aggravated', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Neck pain']",1,MODERNA,SYR 1048733,SC,74.0,F,"Started with bad chills which lasted about 45 minutes then slowly decreased in frequency and duration overnight. Also body aches, joint pain (minor). Next morning (Saturday) temp 101.5 and fatigue. Took 2 500mg Acetaminophen. Slept and rested that next day. Temp decreased over the day . Next day (Sunday) minor fatigue but no temp or body aches etc. Feeling fine by Sunday afternoon.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PHM,"Estradiol Patch 0.05 twice weekly, Simvastatin 20 mg, Losartan 25mg, Chlorthaladone 25 mg (cut in 1/2), Timolol Maleate 0.5% (twice daily each eye, Vit D 3 2000 iu (Two once per day)","TMD, occasional headaches with dizziness","High cholestrol, high blood pressure, glacoma (minor)",,"Penicillin, red food dye","['Arthralgia', 'Chills', 'Fatigue', 'Pain', 'Pyrexia']",2,MODERNA,IM 1048734,FL,66.0,F,rash at injection site a week after the shot,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/22/2021,8.0,PHM,levothyroxine and premarin,none,none,,"Demerol, codeine and cortisone",['Injection site rash'],1,MODERNA,SYR 1048735,SC,100.0,F,Error: Wrong Dose of Vaccine - Too Low,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,01/18/2021,0.0,SEN,,,,,,['Incorrect dose administered'],1,MODERNA,IM 1048737,SC,70.0,F,Error: Wrong Dose of Vaccine - Too Low,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,SEN,,,,,,['Incorrect dose administered'],1,MODERNA,IM 1048738,MA,32.0,F,"PT STATES THAT SHE WAS FEELING WEIRD . PT WAS PALE, STARTED SHAKING AND SAYING THAT SHE WAS GOING TO PASS OUT. PT SLUMPED IN HER CHAIR, SUPPORTED BY 2 RNS, PT UNABLE TO ANSWER PROMPTS. PT TRANSFERRED TO ED. BEDSIDE VITALS IN OBSERVATIONBP 90/66 HR 79",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/20/2021,0.0,PVT,,,,,,"['Blood pressure measurement', 'Feeling abnormal', 'Heart rate', 'Loss of consciousness', 'Pallor', 'Tremor', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 1048739,MN,66.0,F,Error: Wrong Dose of Vaccine - Too High,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,SEN,,,,,,['Incorrect dose administered'],3,MODERNA,IM 1048740,MA,54.0,F,"PATIENT IN OBS AREA FOR 10 MIN WHE SHE BEGAN TO FEEL""PANICKY WITH HEART RACING. HR 144 BP 148/88. REDIRECTION AND REFOCUS ATTEMPTED WITH GOOD EFFECT AS NOTED BY HR DECREASE TO 88-103 AND BP 130/88 100% PATIENT DENIED SOB AND CHEST PAIN. MARKED DECREASE IN SYMPTOMS WHEN CALM, HOWEVER, DIFFICULT TO KEEP HER CALM AND SHE WAS CONVINCED THE VACCINE WAS THE CAUSE OF THE SYMPTOMS. DECISION MADE TO TAKE PATIENT TO THE ER FOR EVALUATION. VS ON D/C 98- 138/73 100%; REPORT GIVEN TO RN ER CHARGE",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,PVT,,,,,,"['Blood pressure abnormal', 'Emotional distress', 'Palpitations']",2,PFIZER\BIONTECH,IM 1048741,VA,47.0,M,"0720: pt c/o feeling ""faint, lightheaded, dizzy"" 10 minutes post second dose of Pfizer COVID-19 vaccine. pt appears pale and diaphoretic. laid to the ground with bilateral lower extremities elevated above level of heart. pt states he feels better a few minutes after intervention. VS BP 121/76, HR 68, RR 16, SPO2 96 on RA, T 97.9.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,MIL,,,,,,"['Dizziness', 'Hyperhidrosis', 'Pallor']",2,PFIZER\BIONTECH,IM 1048742,GA,44.0,F,"Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Swelling and redness in cheeks. Patient described feeling swelling in lips but no swelling was visible. She was given 25mg Benadryl and monitored for approximately an hour with no additional swelling seen and was driven home by a relative.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PHM,,,,,,"['Erythema', 'Eye swelling', 'Lip swelling', 'Mouth swelling', 'Swelling face', 'Swollen tongue']",1,PFIZER\BIONTECH,IM 1048743,,41.0,F,Moderna COVID-19 Vaccine EUA,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/01/2021,02/10/2021,9.0,MIL,,,,,,['Unevaluable event'],UNK,MODERNA, 1048744,CA,21.0,M,"Systemic: Syncope -Severe, Systemic: Hypotension-Severe, Additional Details: Reported blood pressure after 911 paramedics arrived was 56/59. Patient was transported to facility. Called facility 3 times to follow up, but no response yet from facility director. Will follow up again on 2/23/21 in the AM.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/21/2021,02/21/2021,0.0,WRK,,,,,,"['Hypotension', 'Syncope']",1,PFIZER\BIONTECH,IM 1048745,MD,66.0,F,"Death on February 12, 2021 acute cardiac tamponade",Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/12/2021,4.0,MIL,Aspirin 81 MG Calcium Carb 600mg Loratadine 10 Mg Multivitamin Lisnopril 10 MG Mirtazapine 30 MG at bed for mood Simvastatin 20 MG,,Allergic rhinitis benign essential hypertention Depression Generalized Anxiety Hip Pain Total revision of left hip,,Gabapentin- Pain in eye,"['Autopsy', 'Cardiac tamponade', 'Death']",UNK,PFIZER\BIONTECH,SYR 1048746,TN,76.0,F,Systemic: Seizure-Medium,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,SEN,,,,,,['Seizure'],2,MODERNA,IM 1048747,FL,42.0,F,"Client reported ""tingling in back of tongue and throat."" Sensation lasted 15-20 minutes. Resolved without medication intervention. Client reported, ""Sensation is gone. I feel okay now.""",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/20/2021,0.0,OTH,none,,,,Bactrum,"['Paraesthesia oral', 'Pharyngeal paraesthesia']",1,PFIZER\BIONTECH,IM 1048748,NC,67.0,F,The needle came out prematurely (I flinched when the nurse injected it) and some amount of the vaccine just dripped down my arm. It seemed like a lot spilled out.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/10/2021,,,PVT,Alendrenol,,,,,['Incorrect dose administered'],2,PFIZER\BIONTECH,IM 1048749,NH,74.0,F,"Site of vaccine injection started turning red. Itchiness began within twenty minutes of receiving shot. Itchiness was bad enough to put an histamine cream on it. Next morning the arm was swelling and the injection spot swollen more. The redness was worse and the area now hot. I had a slight temperature for a day, The temp went away, chills followed and I was ice cold. Day two after shot the chills left. The spot of injection was getting redder, swelling more and itchy. I am on day three and my arm is swollen, red and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,PHM,Hydrochloratheazide,,Hypertension,,"Shellfish, iodine","['Chills', 'Feeling cold', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Peripheral swelling', 'Pyrexia']",UNK,MODERNA, 1048750,MA,63.0,F,"Pt reported feeling ""woozy"" w/ ""tunnel vision"" whileamb w/ PT to observation area. Pt immediately sat in chair at 9:10am w/ BP 149/82 and HR 74. Pt then t/f to stretcher and placed in supine position. VS cont to be monitored:9:33 - supine - 146/84, 67 denied symptoms c/o ""tunnel vision""9:49 - supine - 138/81, 68 denied symptoms 9:55 - pt sat at EOB and denied symptoms pt was givenwater and crackers w/o issue 10:12 - standing - 132/90, 80 denied symptoms, pt amb across room and back (about 50') w/o LOB or sx",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,PVT,,,,,,"['Blood pressure abnormal', 'Dizziness', 'Tunnel vision']",1,PFIZER\BIONTECH,IM 1048751,KY,76.0,M,"1st vaccine 1/26/21; 2nd vaccine 2/19/21; developed chest pain 2/22/21 and went to ED and admitted to hospital, DX: Chest pain, unspecified type R07.9 786.50",Not Reported,,Not Reported,Yes,,Not Reported,N,02/19/2021,02/22/2021,3.0,PVT,,,Multiple; see chart,,Contrast Dye,['Chest pain'],2,PFIZER\BIONTECH,IM 1048752,MI,24.0,F,"Fever 101-103, soreness, fatigue and chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,PHM,"Soma, Ibuprofen",,,,,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",2,MODERNA,SYR 1048754,FL,71.0,F,Client verbalized feeling dizzy after receiving the vaccine. Client was then evaluated by Fire Rescue and cleared to go home at 8:57 am after symptoms resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,none,none,,,"Penicillin, Codeine","['Dizziness', 'Vital signs measurement']",1,PFIZER\BIONTECH,IM 1048756,IN,35.0,F,"between 7-8 days after the vaccination, itchiness occurring near the injection site. Within 12 hours after initial itchiness, large (2.5"" diameter) hive like spot appearing: red splotchiness, raised skin, hard to the touch, round, warm, extremely itchy. Still in the process of symptoms; this reaction started less than 24 hours ago.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/15/2021,02/22/2021,7.0,OTH,none,none,none,,avocado,"['Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria', 'Injection site warmth']",UNK,MODERNA,SYR 1048757,FL,68.0,F,"#1 Moderna vaccine 1/22/21 @1210hours at right deltoid Date of second shot was not recorded for report 2nd vaccine caused side effects started the next day - woke up feeling very weak, headache, eyes hurting, fever not measured, felt confused, dizzy, vomited x2",Not Reported,,Not Reported,Not Reported,,Not Reported,,,,,PVT,Pravastatin Vit D +Calcium,,hyperlipidemia,,None,"['Asthenia', 'Confusional state', 'Dizziness', 'Eye pain', 'Headache', 'Pyrexia', 'Vomiting']",2,MODERNA,IM 1048758,OK,43.0,F,Tightness in left arm immediately; dizziness - 2 hrs later; significant diarrhea from 8pm - 4am.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,OTH,Celebrex; Soma; Percocet; Wellbutrin; Lexapro,none,None,,Sulfa; gluten meal,"['Diarrhoea', 'Dizziness', 'Limb discomfort']",1,PFIZER\BIONTECH,IM 1048759,NY,71.0,F,One week after the injection the site got hard with a red itchy rash . I am using ice and cortisone cream to treat it. It has been 2 days at this point with no change.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/21/2021,7.0,OTH,Livothyroxin and Dexilant,None,GERD and Hypothyroigism,Shingles vaccination,None,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 1048760,PA,25.0,M,"Insomnia, mania, severe psychosis",Not Reported,,Not Reported,Yes,8.0,Yes,N,02/12/2021,02/13/2021,1.0,PVT,Prozac,,Cerebral Palsy Aspergers,,,"['Activated partial thromboplastin time', 'Blood albumin', 'Blood ethanol', 'Blood glucose', 'Blood lactic acid', 'Blood magnesium', 'Blood phosphorus', 'Blood thyroid stimulating hormone', 'Ceruloplasmin', 'Cryptococcus test', 'Differential white blood cell count', 'Drug screen', 'Electrocardiogram', 'Full blood count', 'Haemoglobin', 'Influenza A virus test', 'Influenza B virus test', 'Insomnia', 'International normalised ratio', 'Lipids', 'Liver function test', 'Magnetic resonance imaging brain', 'Mania', 'Metabolic function test', 'Protein total', 'Prothrombin time', 'Psychotic disorder', 'SARS-CoV-2 test', 'Scan with contrast', 'Toxicologic test', 'Urine analysis', 'Vitamin B12']",UNK,MODERNA, 1048761,OH,43.0,F,"The day after the shot the injection site and left arm were extremely sore, and it was very difficult to lift my arm. I have been having headaches and body aches. I have had trouble sleeping and wake up with soreness and aching in my joints where I typically do not have soreness. Today, I am experiencing some soreness and muscle strength loss in the arm where I received the injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/12/2021,1.0,WRK,Amlodipine and levothyroxine,none,none,,amoxicillin,"['Asthenia', 'Headache', 'Injected limb mobility decreased', 'Injection site pain', 'Pain', 'Pain in extremity']",1,MODERNA,IM 1048762,MI,63.0,M,"The next day, developed mild peri-orbital edema. No other symptoms. It resolved in one week. He received the second dose in the series. The same thing happened.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/29/2021,1.0,PUB,,,Psoriatic arthritis COPD PTSD Cardiomyopathy DM2,,,['Periorbital oedema'],UNK,PFIZER\BIONTECH,IM 1048763,OH,85.0,F,New onset Atrial Fibrillation,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/23/2021,6.0,PVT,,,"hypertension, hyperlipidemia",,,"['Atrial fibrillation', 'Electrocardiogram']",2,MODERNA, 1048764,VA,59.0,F,Fever (99.9) Severe muscle and joint pain all over Exhaustion Moderate by 4 hours post injection Much more severe the first day after Moderate the second day after Gone by third day after,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PUB,Mycophenolate mofetil 1500 mg 2x/day Progesterone 100 mg /day Estrogen patch Baby aspirin Vitamin d,None,Autoimmune uveitis/choroiditis,,"Penicillin, sulfa","['Arthralgia', 'Fatigue', 'Myalgia', 'Pyrexia']",2,MODERNA,IM 1048765,NY,71.0,M,Severe pain at injection site started 11 days after vaccination. Pain is constant even if not moving arm. Minor pain after injection lasted about 2 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/22/2021,11.0,PHM,None,None,None,,None,['Injection site pain'],UNK,MODERNA, 1048777,CA,,U,"Hives; facial swelling; felt throat closing; late phase reaction; This case was reported by a physician via call center representative and described the occurrence of hives in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis. Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, immediately after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced hives (serious criteria other: as per reporter), facial swelling (serious criteria other: as per reporter), throat constriction (serious criteria other: As per reporter) and delayed type hypersensitivity (serious criteria other: as per reporter). The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the hives, facial swelling and throat constriction were recovering/resolving and the outcome of the delayed type hypersensitivity was recovered/resolved. It was unknown if the reporter considered the hives, facial swelling, throat constriction and delayed type hypersensitivity to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: Age at vaccination was not reported. The patient experienced Immediate severe reaction as hives, facial swelling, felt throat closing. The patient was given 50 mg Benadryl and symptoms improved but the patient had a late phase reaction that clear with Benadryl. No adrenaline given. The reporter asked what are the ingredients in the Flulaval Quadrivalent season 2020-2021? The reporter wanted to know if the vaccine contain Flulaval Q contain PEG or polysorbate? The reporter did not consent to follow-up. No additional information was provided.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Immediate post-injection reaction', 'Swelling face', 'Throat tightness', 'Type IV hypersensitivity reaction', 'Urticaria']",UNK,GLAXOSMITHKLINE BIOLOGICALS, 1048778,NY,,F,"16 year old received moderna vaccine; A spontaneous report received from a Consumer concerning, 16-year-old female patient who received Moderna COVID-19 vaccine /MedDRA PT: [Inappropriate Age]. The patient's medical history was not included/ unknown. Patient's concomitant was not included/ unknown. On 13-JAN-2021, the patient received their first of two planned doses of mRNA-1273 in her left arm (Batch #: 012L20A) intramuscularly for prophylaxis of COVID-19 infection. On 10-FEB-2021 patient's mother stated that her 16-year-old daughter received the first dose of the Moderna COVID-19 vaccine. Mother stated that her daughter was scheduled to receive the second dose on 10Feb2021. The local health department denied patient the second dose and advised patient to reach out to the Moderna clinical trial so she could receive the second dose. Treatment information was not provided/ unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was unknown/not reported.; Reporter's Comments: This case concerns a 16 year old female who received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1048779,CA,,M,"Moderna vaccine given to a 17 year old patient; A spontaneous report was received from a healthcare professional concerning a 17 year old male patient, who was administered Moderna's COVID-19 vaccine and product administered to patient of inappropriate age. The patient's medical history was not provided. No relevant concomitant medications were reported. On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly for prophylaxis of Covid-19 infection. It was reported that they inadvertently gave the Moderna vaccine to a 17 year old male patient on 15 Jan 2021. They misread birthdate. No further information was provided. No treatment information was reported. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event, Moderna vaccine given to a 17 year old patient, was considered resolved on 15 Jan 2021.; Reporter's Comments: This case concerns a 17 year old male who received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1048780,NY,16.0,M,"16 year old patient vaccinated; A spontaneous report was received from a consumer concerning a 16-year-old female patient who received both doses, The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On unknown date, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. The patient received both doses and is only 16-years old. She forgot when she got vaccinated. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The outcome for the event was considered resolved.; Reporter's Comments: This case concerns a 16 year old female who received her second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age who received both doses.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Product administered to patient of inappropriate age'],2,MODERNA,OT 1048781,TX,,U,"speculation that a patient may have been administered a second dose subcutaneously; A spontaneous report was received from a pharmacist concerning a patient, who experienced an event of inappropriate route of vaccine administration. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: not provided) on an unspecified date. On an unspecified date, the patient received their second dose of mRNA-1273 (Batch number: not provided) subcutaneously for the prophylaxis of COVID-19 infection. On an unspecified date, the patient received the second dose of vaccine resulting in the event of inappropriate route of vaccine administration. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, inappropriate route of vaccine administration, was considered resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot# unknown) after the second dose was administered with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Incorrect route of product administration'],1,MODERNA,OT 1048782,NM,,M,"patient did not get the full 0.5 ml dose; Part come out between the needle and syringe; A spontaneous report was received from a nurse concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and did not get the full 0.5 ml dose and part come out between the needle and syringe. The patient's medical history was not provided. No concomitant medications were reported. On 08 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031M20a) intramuscularly for prophylaxis of COVID-19 infection. While receiving the vaccine, the nurse stated that part of it went into the patient's arm and part come out between the needle and syringe. The patient did not get the full 0.5 ml dose and the nurse couldn't guess how much he received. Action taken with mRNA-1273 in response to the events was not provided. The events did not get the full 0.5 ml dose and part come out between the needle and syringe were considered resolved on 08 Feb 2021.; Reporter's Comments: This report refers to a case of syringe issue and underdose with mRNA-1273 (Lot number: 031M20a) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Device connection issue', 'Underdose']",1,MODERNA,OT 1048783,CT,35.0,F,"Some of the vaccine came out and was not completely administered; The syringe and needle came apart; A spontaneous report was received by a pharmacist regarding a 35-year-old female patient who experienced the needle and syringe coming apart while administering vaccine/syringe connection issue and the dose was not completely administered/vaccine underdose. The patient's medical history was not provided. No concomitant medications provided. On 10 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Batch number: 010M20A Expiration date: 19 Jul 2021) administered intramuscularly into the arm for prophylaxis of COVID-19 infection. The patient received the second injection on 10 Feb 2021 and the pharmacist reported that the needle and the syringe came apart and some of the vaccine came out and was not administered. They believe the patient got approximately half of a dose. Treatment information was not provided. Consent to contact was obtained. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, needle and the syringe came apart and some of the vaccine came out and was not administered, was considered resolved.; Reporter's Comments: This report refers to a case of vaccine underdose and syringe issue for mRNA-1273 (lot # 010M20A) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical History Not Provided),,,"['Device connection issue', 'Underdose']",2,MODERNA,OT 1048784,OH,,F,"Unable to receive second dose within the extended dosing window of 42 days; A spontaneous report was received from a consumer concerning a female patient, of unknown age, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and the patient would be unable to receive second dose within the extended dosing window of forty-two days/ inappropriate schedule of product administration. The patient's medical history included a broken hip. No relevant concomitant medications were reported. On 04 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. The patient was originally scheduled for her second Moderna COVID-19 vaccine on 02 FEB 2021. The patient was hospitalized due to a broken hip that occurred prior to receiving her first dose of the vaccine and has not been released to receive her second dose. The patient was kept at the hospital for a scheduled hip replacement on 16 FEB 2021 and will not be released to receive the second vaccine. The hospital would not allow a vaccination provider to administer at the hospital where she was staying and therefore would be unable to receive her second dose within the extended dosing window of forty-two days. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was unknown. The outcome of event, would be unable to receive second dose within the extended dosing window of forty-two days was considered as resolved.; Reporter's Comments: This case concerns a female patient of unknown age who would be unable to receive second dose within the extended dosing window of forty-two days(inappropriate schedule of product administration )for mRNA-1273 vaccine. ( Lot # not available as vaccine is yet to be administered) .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,,,UNK,,Broken hip,,,,['Inappropriate schedule of product administration'],1,MODERNA,OT 1048787,TX,39.0,F,"Red itchy injection site, swollen nodes under right arm, itchy right arm pit",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/20/2021,6.0,PHM,None,None,None,,"Latex, flonaise, cephlex, tramadol","['Injection site erythema', 'Injection site pruritus', 'Lymphadenopathy', 'Pruritus']",1,MODERNA,IM 1048788,PA,49.0,F,"Redness, soreness at the site of the smallpox vaccine scar. Smallpox was administered in childhood in the country. COVID vaccine injection site is about two inches away from the smallpox scar.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,PVT,"atenolol, atorvastatin, synthroid, xolair",,,,,"['Erythema', 'Injection site discomfort']",2,PFIZER\BIONTECH,IM 1048789,NC,61.0,M,Muscle and joint pain Exhaustion Fever (101) Chills All began by 4 hours post injection and resolved by morning of 2nd day post injection,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PUB,Testosterone supplement,None,None,,Sulfa,"['Arthralgia', 'Chills', 'Fatigue', 'Myalgia', 'Pyrexia']",2,MODERNA,IM 1048791,OH,50.0,F,pain in armpit on left arm that extends into elbow,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/21/2021,2.0,OTH,"RX - synthroid, diltiazem, folic acid, lamotrigine, hydroxyzine OTC - allegra, multivitamins, melatonin, supplements","Rheumatoid Arthritis, raynaud's, hypothyroidism, coronary artery vasospasms, vitiligo,","Rheumatoid Arthritis, raynaud's, hypothyroidism, coronary artery vasospasms, vitiligo,",,"Penicillin, Sulpha drugs",['Axillary pain'],1,PFIZER\BIONTECH,IM 1048792,NY,53.0,F,"Aside from the usual chills arm pain aches and general malaise for 5 days , I?ve had more frequent and looser stools and stomach cramping since the day of the vaccine .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,PVT,Maxide 1/2 tab daily ( have been on for 9 years ),None,M�ni�re?s disease,,Scallops ( upset stomach vomiting ),"['Abdominal pain upper', 'Chills', 'Diarrhoea', 'Frequent bowel movements', 'Malaise', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 1048793,CT,73.0,F,9 days post injection Red raised hard rash around injection site 3+ inches in diameter Itchy,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/20/2021,9.0,OTH,Forteo subcu,None,Asthma PMR 2019,,Synthetic morphime,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling']",1,MODERNA,IM 1048794,IL,41.0,F,Moderna COVID-19 Vaccine EUA Rash near the injection area 1 week after receiving 1st dose of the vaccine. Itchy and appears to be patchy/legions.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/15/2021,02/22/2021,7.0,SCH,None,None,None,,Penicillin and Clindamycin,"['Injection site rash', 'Pruritus', 'Rash', 'Skin lesion']",1,MODERNA,SYR 1048795,KS,26.0,F,"Fever, fatigue, nausea, and R arm pain (like a lot)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,UNK,Nuva Ring,None,None,,None,"['Fatigue', 'Nausea', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 1048796,FL,80.0,M,Fatigue swollen lips mouth and tongue sore lips bleeding chest burning No treatment Lasted one week,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,02/01/2021,17.0,PVT,"Eliquis, Olmesa Medox",No,Kidney,,No,"['Chest pain', 'Fatigue', 'Glossodynia', 'Lip haemorrhage', 'Lip pain', 'Lip swelling', 'Oral pain', 'Oropharyngeal pain']",2,PFIZER\BIONTECH,IM 1048797,MD,74.0,F,"Light headed, not functioning in a normal manner, moving slow/ balance, mildly dizzy, and lack the feeling without well being and conscious control",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/11/2021,2.0,PHM,"Pravastatin Sodium 20mg, Synthroid 75 mcg, Enalapril HCTZ 10 - 25 mg , Ezetimibe 10 mg, and two (2) over the counter medications CoQ10 200 mg and Aspirin 81 mg",None,Thyroid,,None,"['Balance disorder', 'Dizziness', 'Dyskinesia', 'Feeling abnormal']",1,MODERNA,SYR 1048798,GA,70.0,M,"Post nasal drip, runny nose, chest discomfort, cough. Began two days after injection. Improved after two days, but still have mild symptoms. No fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/20/2021,2.0,OTH,Bupropion Eliquis Synthroid Pantoprazole,,Chronic Lymphocytic Leukemia Blood clotting disorder,"extreme fatigue, body aches for two days. 69 yrs. old. 10/2020",,"['Chest discomfort', 'Cough', 'Rhinorrhoea', 'Upper-airway cough syndrome']",2,PFIZER\BIONTECH,IM 1048799,WA,50.0,F,"Headache, muscle ache, fatigue. labored breathing but not severe enough to go to the Emergency Room.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,UNK,"Benadryl, flonase, Lisinopril",,"High Blood Pressure, Obesity",Flu Shot October 2020 - do not know exact date or brand name,"Penicillin, Flu Shot","['Dyspnoea', 'Fatigue', 'Headache', 'Myalgia']",1,PFIZER\BIONTECH,SYR 1048800,KY,72.0,F,"Researched Covid Arm --Pain and hard red spot about the size of a quarter -- faded after 3 days but return after 10 days when scratched or rubbed site, fading again",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,PUB,"Omeprazole 20mg, Simvastatin 40 mg, Lubrisyn, Vitiman B12 1000mcg",none,"reflux, high cholesterol",,Wool,"['Induration', 'Pain in extremity']",1,MODERNA,IM 1048801,FL,81.0,F,"As I washed up in the morning, about 8 a.m., I noticed my underarm was sore. As I examined the area several times during the next couple of hours I noticed a lump. The lump was moveable, but seemed about the size of a nickle. It scared me even though it was not actually in my breast. The doctor told me since it was moveable and felt smooth he thought it to be a reaction to the Covid vaccine, but ordered a mammogram. I called for the mammogram and was told I could not have one until 4 weeks after the 2nd shot. I have a mammogram scheduled 3/26/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,02/11/2021,12.0,PVT,Once a month (taken the first day of the month) Ibandronate Sodium Tablet.,None,None. Take no medicine other than the above to ward off osteoporosis.,,None,"['Adverse reaction', 'Axillary mass', 'Axillary pain']",1,PFIZER\BIONTECH,IM 1048802,MA,62.0,F,"after the first moderna vaccine on 12/24, i had pain in both legs that persisted for over a month. i didn't think it was related to the vaccine. then after i had the 2nd vaccine on 1/21, i developed very painful aching in both shoulders, arms, wrists, which has persisted and worsened, along with persistent fatigue. i met (remotely) with my pcp. lab tests were unremarkable.� she prescribed prednisone and the pain�was much less during the day, but severe when I woke in the mornings.��I met with a rheumatologist who advised me to stay off prednisone for 10 days to allow further testing�to r/o polymyalgia reumatica secondary to the vaccine.� Since stopping prednisone the pain�in my shoulders, arms, wrists and hands has intensified, as has my fatigue.� i have no prior�hx of pain, autoimmune or rhematolocal conditions. I'm pretty stubborn, and have continued to work despite sxs.� I missed last Friday 2/19 because the pain was so severe.�",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/25/2020,1.0,WRK,,,,,,"['Arthralgia', 'Fatigue', 'Pain in extremity']",1,MODERNA,IM 1048803,NH,44.0,F,"On 2.23.20321 began to note itchy hives over both arms. More concentrated at vaccine sites, legs and torso.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/22/2021,11.0,UNK,,,,,,"['Pruritus', 'Urticaria']",2,MODERNA,IM 1048804,NJ,46.0,F,"Itchy, hot rash developed on arms. 24 hours later rash progressed to chest, neck and lower face. Not located at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/20/2021,8.0,PHM,None,None,None,,None,"['Rash', 'Rash pruritic', 'Skin warm']",UNK,MODERNA, 1048806,FL,68.0,F,Sudden appearance of redness around injection site 10 days after the injection. Not itchy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/23/2021,11.0,PHM,,,,,,['Injection site erythema'],UNK,MODERNA,SYR 1048807,OH,78.0,M,"Patient received his first dose of vaccine on 2/10 at 11:30am. (His 2nd is scheduled for 3/3) He started with sx ~13 hrs later - He started drifting out of consciousness, then had labored breathing through night rendering him unable to sleep. After getting up in the morning, his breathing was better but he felt lightheaded/weak through the day. By the next morning (Friday 2/12), he was so bad next morning that wife called 911 - He reports that he was there and then not there and was losing track of train of thought. He was taken to ER via EMS, where his HR was initially 15 - He was admitted to hospital - initially a temporary pacer was placed, then a permanent one on Monday, 2/22. He has had other episodes like this in past 13 mos. PCP referred him to neurologist and EENT. Neurology work-up, including MRI and 72 hr EEG were unremarkable, although he learned retrospectively that there was a time during EEG where HR was only 35. EENT found no auditory or other issues . *MD in ER told him that if issues were not neuro in nature, they were probably cardiac.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/10/2021,02/11/2021,1.0,PUB,"Eliquis, carvedilol, losartan, hydralazine, rosuvastatin, levothyroxine; apap prn",,"hypothyroidism, borderline HTN, a.fib., hypercholesterolemia; also dx'ed with hypothyroidism and kidney problems during recent hospital visit",,,"['Asthenia', 'Consciousness fluctuating', 'Dizziness', 'Dyspnoea', 'Electroencephalogram normal', 'Magnetic resonance imaging normal', 'Memory impairment', 'Neurological examination', 'Sleep disorder']",1,PFIZER\BIONTECH,IM 1048808,TX,69.0,M,strong groin pain made it difficult to stand erect. pain is still present today although not as severe.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,PVT,"warafarin, doxazosin, atoravastin, lasix, klor-con, montelukast sodium, valsartan",,pulmonary fibrosis,,penicillin,"['Dysstasia', 'Groin pain']",1,PFIZER\BIONTECH,SYR 1048810,OK,66.0,F,"About 8 hrs after shot my mind started feeling foggy and heavy head, i got nauseous and achy joints and having breathing problems. i was just sic. or like i had the flu or covid again. went on through the night. was up all night. my arm was just killing me. The next morning i was full on sick. the nausea was intense my temp throughout day was 99.6 and 99.9 . out of breath. That night i went to bed and woke up at midnight and was drenched my hair was soaked Got up at showered. at the 3:30 woke up again totally drenched. yesterday i woke up and 6:00 am i was feeling better but still trouble breathing but everything else was gone. I was tired still. About 10:30 yesterday Everything was fine. I do still have a little trouble breathing but not as bad.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,,,,,,"['Arthralgia', 'Body temperature increased', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Head discomfort', 'Hyperhidrosis', 'Influenza like illness', 'Insomnia', 'Nausea', 'Pain in extremity', 'Sleep disorder']",1,PFIZER\BIONTECH,IM 1048811,PR,27.0,F,"Patient indicates that after 5 days after administration started feeling headaches, body aches. Test results indicate Positive to COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/22/2020,5.0,PVT,None.,None.,None.,,None.,"['Headache', 'Influenza virus test', 'Pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1048812,,74.0,F,8 days after vaccination - stroke/full right side of body paralyzed - clot buster drug at ER,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/11/2021,02/19/2021,8.0,PHM,No Rx,none,hashimoto's disease,,"morphine, sulpha, procaine,","['Blood test', 'Cerebrovascular accident', 'Computerised tomogram', 'Hemiplegia', 'Magnetic resonance imaging', 'Paralysis', 'Ultrasound Doppler']",1,MODERNA,IM 1048813,,66.0,F,Rash on trunk. 13 and still profuse,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/10/2021,1.0,PHM,Lipitor,,Hashimoto's,"Flu vaccine, chills, muscle ache,mfatigue",Penicillin,['Rash'],UNK,PFIZER\BIONTECH, 1048814,FL,81.0,F,"DELAYED LOCAL REACTION AT INJECTION SITE, WITH MUSCULAR INVOLVEMENT, STILL PRESENT FIVE (5) WEEKS.AFTER INJECTION 1- SEVERE PAIN IN LEFT ARM, INCREASING OVER TIME, LIMITING MOVEMENT; 2-SWELLING IN THE AREA AROUND INJECTION SITE; 3- AREA WARM TO THE TOUCH; 4-RUBOR IN THE AREA. SYMPTOMS SUGGESTED DEEP VENOUS THROMBOSIS, BUT ULTRASOUND FOUND NO CLOTS.. ANOTHER POSSIBILITY COULD BE BICEPS TENDONITIS, BUT ETIOLOGY NOT CLEAR. MEDROL GIVEN FOR 5 DAYS DECREASED SYMPTOMS, BUT SWELLING, RUBOR, AND PAIN PERSIST FIVE WEEKS AFTER INJECTION. SEVERE LOCAL REACTION TO INJECTION, AFFECTING MUSCLE?",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/27/2021,7.0,OTH,NONE,NONE,OSTEOPOROSIS,,NONE,"['Injected limb mobility decreased', 'Injection site erythema', 'Injection site pain', 'Injection site rash', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Ultrasound scan normal']",1,MODERNA,IM 1048815,ME,60.0,M,"approximately 24 hrs after shot in left arm, IM, Left armpit swelling, assume lymph nodes. Slightly painful. Pain went from a 4 out of 10 to a 2 in 24 hrs, to 0 after 48 hours. Armpit is still swollen now. Visually obvious but no pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,OTH,"Multi-vitamin, Ginseng, Flax seed oil capsules","no other illnesses Positive Covid test 01/05/2021, negative Covid test 01/17/2021",none,,none known,"['Oedema peripheral', 'Pain']",1,MODERNA,IM 1048816,KY,48.0,F,Reddened warm knot area on arm where injection was done. Still there 2 weeks later improving,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/05/2021,2.0,PUB,,,,,,"['Injection site erythema', 'Injection site nodule', 'Injection site warmth']",1,MODERNA,IM 1048817,AL,46.0,F,"Day 2-3: fever, chills, body aches, joint and muscle pain, headache, nausea, fatigue and vomiting Day 4-5: felt completely fine Day 5-6: that evening, all of the same symptoms returned, including fever of 102 Day 7-9: felt completely fine Day 10-11: all symptoms returned, including fever of 101 Day 12: today, feel completely fine",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/13/2021,1.0,PVT,"Losartan 25mg, Pristiq 50 mg",Hypertension,Asthma (controlled),,codeine,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",UNK,PFIZER\BIONTECH,SYR 1048818,AZ,84.0,F,"Never even felt the shot No adverse effects - not even sore at the site Today (10 after receiving the shot) the arm has red blotches at the site, is itching, hot, there is a hard lump Otherwise I feel fine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/23/2021,10.0,OTH,Atorvastatin Estradiol Losartan Potassium Mature Multi Vitamins Naproxen Sodium Calcium Citrate Magnesium Zindw/Vitamin D3 Bayer Aspirin 81 mg Flaxseed Oil 1000 mg,No,none,,None that I know of,"['Injection site nodule', 'Injection site pruritus', 'Injection site warmth', 'Rash macular']",1,MODERNA,IM 1048819,FL,74.0,F,Low grade fever (100 degrees) for 24 hours Pain at injection site for 48 hours Pain when lifting my left arm for 36 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,OTH,Fish Oil 1200mg Calcium 600+D 1200mg Centrum Silver for Women,None,None,,Sulfa,"['Injection site pain', 'Pain', 'Pyrexia']",UNK,MODERNA, 1048820,SC,60.0,M,Bells Palsey,Not Reported,,Not Reported,Not Reported,,Yes,N,02/01/2021,02/18/2021,17.0,PVT,Glipizide. Hydralazine. Sidenifil. Bostolic. Lisinopril. Amlodapine. Atorvastatin. Beet Root supplement. Saw Palmetto,None,Type 2 Diabetic. Hypertention,,Penecillan,['Facial paralysis'],UNK,PFIZER\BIONTECH, 1048821,OH,90.0,M,"Subsequent morning after vaccination, client was too weak to get out of bed (per wife). He stayed in bed for 3 to 4 days , then wife called PCP. Client stayed in bed for a total of 3 weeks , and had 3 home visits from PCP. Was admitted for rehabilitation on 2-13-2021. for a diagnosis of failure to thrive. Client is still at this facility as of this date.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/19/2021,01/20/2021,1.0,PUB,"Mirtazapine. Simvastatin, Levothyroxine, Tamsulosin, Fish Oil, Vitamin D, Carvedilol, and Iron.",None per Wife.,Arthritis and had open heart surgery a few years ago . (per wife),,Sulfa- Unknown,"['Adult failure to thrive', 'Asthenia', 'General physical health deterioration']",1,MODERNA,IM 1048822,FL,89.0,M,"Aches, Extreme chills(Chattering Teeth), no strength in legs.Could not stand up.EMS took him to hospital at 6:30 PM 2/20/2021. Extremely dehydrated. He was discharged the next afternoon at4 PM. Diagnosis: Elevated lactic acid level and fever after COVID -19 vaccination.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/19/2021,02/20/2021,1.0,UNK,,,"Sinusitis, Hay fever",,,"['Blood lactic acid increased', 'Blood test normal', 'Chills', 'Computerised tomogram normal', 'Dehydration', 'Dysstasia', 'Muscular weakness', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",2,MODERNA,SYR 1048823,TX,79.0,F,"Patient received her Covid 19 Vaccination on 2-11-21. I counselled her about side effects and asked her to wait 15 minutes. She waited and as she was leaving she fell to the floor and hit her head. The other patients around her said it looked like she slipped, but when speaking to her it seemed that she had become dizzy and fell. I spoke with her after she fell, she did not loose conscienceness, but was disoriented. She did know what day it was, who she was and where she was. She said her head hurt and she could move all her limbs. I asked the store director, to call for an ambulance. I sit with her for a few minutes and talked to her, then asked store director to stay with her until the ambulance arrived. They arrived and spoke with her and decided to transport her to the hospital. Later that day, her sister in law came by and said she was doing fine and had been released. The doctors indicated they thought she because dizzy due to dehydration",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,PHM,"Synthroid 88mcg, Timolol 10mg tablets, Estradiol 2mg, Citalopram 40mg, HCTZ 25mg, Nexium 40, Magnesium Oxide 400mg, Cyclobenzaprine 10mg, Norco 10/325, Hyoscyamine 0.125mg, Xiidra Opthalmic,",Not Known,"Hypothyroidism, Chronic Pain, Depression, Heart Arrhythmia",,Sulfa,"['Dehydration', 'Disorientation', 'Dizziness', 'Fall', 'Head injury']",1,MODERNA,IM 1048824,AZ,84.0,F,"UKNOWN BRAND OF VACCINE; lightheadedness and arm ""heaviness"" status post receiving the first COVID vaccine 30 minutes PTA.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PVT,"allopurinol, omeprazole, spironolactone, clonidine",,"Hypertension, renal disorder, hx of abdominal surgery",Pneumoccoal; swelling,Pneumococcal vaccine,"['Dizziness', 'Limb discomfort']",1,PFIZER\BIONTECH, 1048825,IN,75.0,F,"Extreme backache, fever, redness at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,"2,5 mg prednisone 75mcg levothyroxine 200mg hydroxychloroquine",none,rheumatoid arthritis,,none,"['Back pain', 'Injection site erythema', 'Pyrexia']",UNK,MODERNA, 1048826,KY,85.0,F,"1st Dose vaccine 1/29/21; Admitted to Hospital from ED 2/1/21-2/4/21 Dx PNA, d/c'd home. ; 2nd dose vaccine 2/19/21; seen in ED 2/22/21 for SOA, congestion, N/V, and Left flank pain x 3 days; admitted to hospital from ED 2/22/21 Dx: 1. Epigastric pain R10.13 789.06 2. Elevated brain natriuretic peptide (BNP) level R79.89 790.99 3. Dyspnea, unspecified type R06.00 786.09 4. Abnormal CT of the abdomen R93.5 793.6 5. Hypomagnesemia E83.42 275.2 6. Hypokalemia E87.6 276.8 Currently still admitted to hospital at time of this report. �",Not Reported,,Not Reported,Yes,,Not Reported,U,02/19/2021,02/20/2021,1.0,PVT,,,Multiple; see chart,"Unknown vaccine; 1st covid vaccine questionnaire documented ""NO"" if ever had allergic reaction to previous vaccine; 2nd covid v",NKA,"['Abdominal pain upper', 'Brain natriuretic peptide increased', 'Computerised tomogram abdomen abnormal', 'Dyspnoea', 'Flank pain', 'Hypokalaemia', 'Hypomagnesaemia', 'Nausea', 'Pneumonia', 'Pulmonary amyloidosis', 'Respiratory tract congestion', 'Vomiting']",2,PFIZER\BIONTECH,IM 1048827,SC,72.0,F,Rash on vaccine site and neck,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/20/2021,4.0,OTH,"Pravastation 40mg Triamterene/Hctz 37.5 Castrates 600 Centrum silver Fish oil 1000. Vitamin D3. Ashwagandha, pure Selenium, potassium",None,None,,Sulfa,"['Rash', 'Vaccination site rash']",2,PFIZER\BIONTECH, 1048828,MA,60.0,M,Swollen lymph nodes under right armpit about the size of an egg.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/18/2021,3.0,OTH,"Pantoprazole 40mg, Losartan 100mg, Rosuvastatin 5 mg, Magnesium 200 mg, Resveratrol 250 mg, Multi Vitamin, Fish Oil 1200 mg, Ubiquinol CoQ10 100mg",None - Note this occurred on my second Pfizer shot. No side effects on the first shot administered on 1/25/21.,"Elevated BP, High Cholesterol",,None,['Lymphadenopathy'],2,PFIZER\BIONTECH,IM 1048829,NC,66.0,F,"This was the second dose in the vaccine series. The patient reported doing well for the first dose. A few minutes after receiving her second dose, the patient started to complain of lightheadedness, lethargy, arm weakness. She reported she did have an anaphylactic reaction to the H1N1 vaccine . Patient reported about 10 minutes after she received the vaccine she was starting to feel better- less lightheaded and was gaining arm strength. She was moved to a chair and she could not support her weight. EMS was called to the scene and she was transported to the ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,MIL,,,Diabetes,H1N1,H1N1 VACCINE,"['Dizziness', 'Lethargy', 'Muscular weakness', 'Weight bearing difficulty']",2,PFIZER\BIONTECH,IM 1048830,FL,71.0,F,Rash on both wrist area. Pimples on each armpit/breast area and left forearm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,OTH,"Amlodipine, Diclofenac, Paroxetine, Omeprazole, B12, D3, Zinc, 81mg aspirin, Calcium,",Arthritis pain and inflammation,Begin taking Amlodipine Nov 2020. Diclofenac Feb 2021 Other Rx meds 4-5 years,Flu/pneumonia,"Lisinopril, Codeine","['Dermatitis acneiform', 'Rash']",UNK,PFIZER\BIONTECH, 1048831,AZ,39.0,M,presenting to the emergency department via car for evaluation of Herpes Zoster to the left side of the patient's face. The patient was evaluated at Urgent Care yesterday and sent by the NP. Patient reports three days of rash to the left side of his face with redness and swelling. The patient initially thought the rash was acne due to his face mask. There is intermittent pain to the area which is rated 10/10 severity at its worst. The patient has been unable to sleep the past two days due to the pain. Pain is worse with cold weather and at night with increased clenching of his jaw and grinding of his teeth. He was prescribed Valtrex at Urgent Care and took one dose just PTA to the ED. There is concern given a bump just lateral to the patient's left eye. The patient received his first COVID-19 vaccination on 01/18/2021 and explains that the Urgent Care provider believes this may be an adverse reaction.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,01/28/2021,10.0,PVT,,,ADHD; allergic rhinitis,,,"['Adverse reaction', 'Erythema', 'Facial pain', 'Herpes zoster', 'Insomnia', 'Mass', 'Rash', 'Swelling face']",UNK,PFIZER\BIONTECH, 1048832,PA,22.0,F,"Patient had rash on face and chest, vomiting for over 24 hours, fever, chills, extreme fatigue and body aches. Benadryl was taken.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,SEN,,,,,,"['Chills', 'Fatigue', 'Pain', 'Pyrexia', 'Rash', 'Vomiting']",2,PFIZER\BIONTECH,IM 1048833,,31.0,F,~ 5 weeks pregnant at the time of 2nd vaccination. Miscarriage ~2 weeks later. Transvaginal ultrasound shows gestational age only 5 weeks when should have been 7. HCG level reflects only 4-5 weeks when should have been 7.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,02/07/2021,16.0,WRK,"zyrtec, calcium w/ vitamin d, prenatal vitamns",,,,"ibuprofen, shrimp, strawberries","['Abortion spontaneous', 'Exposure during pregnancy', 'Gestational age test abnormal', 'Human chorionic gonadotropin', 'Human chorionic gonadotropin abnormal', 'Ultrasound scan vagina']",2,PFIZER\BIONTECH,IM 1048835,MD,74.0,M,Multiple Seizures: no long term side effects,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/03/2021,02/05/2021,2.0,PVT,,,Parkinsons MCA/PCA Stroke 6/15/2021,,None,['Seizure'],UNK,PFIZER\BIONTECH, 1048836,IN,53.0,F,"At approximately 9:30 pm, my bpm increased dramatically. I normally have a 70 - 85 bpm and last my my heart rate ranged from 120 - 152 while lying in bed. It still is above 100 today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,PVT,Tylenol Metformin Montelukast Pravastatin Duloetine Vitamin C Vitamin B12 Vitamin B Complex Melatonin Apple Cider Vinegar,Insulin resistance,na,,na,['Heart rate increased'],UNK,PFIZER\BIONTECH, 1048837,PA,75.0,F,The second day I got a fever of 101.9 and later 101. The fourth day my arm was hotter and more sore than previously and noticed it had a big red circle around the injection site. It is now the next day and after putting ice on it it still itches and is less sore.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2020,02/22/2021,369.0,PUB,"Synthroid, Valsartan-HCTZ, Metoprolol Suc, Atorvastatin",None,"Hashimoto Disease, High Blood Pressure",,None,"['Injection site erythema', 'Pain in extremity', 'Pyrexia', 'Skin warm']",2,MODERNA,SYR 1048838,,81.0,F,Patient was administered the second dose 15 days after the first dose (administration error).,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/06/2021,02/20/2021,14.0,UNK,,,,,,['Inappropriate schedule of product administration'],2,PFIZER\BIONTECH,IM 1048839,MA,33.0,F,"Patient got unconscious. Patient was sent 911. After following up with facility, patient was stable and doing well. Patient was sent home that evening.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/21/2021,02/21/2021,0.0,OTH,,,,,,['Loss of consciousness'],1,PFIZER\BIONTECH,IM 1048840,OH,69.0,F,"Slight itch, red rash around injection site, skin warm for 3 days (so far)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/20/2021,12.0,UNK,"Atorvastatin 10 mg, Hair, Skin & Nails",None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,MODERNA,IM 1048841,ME,89.0,M,DVT Right leg Femur,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,UNK,,,,,,"['Deep vein thrombosis', 'Ultrasound Doppler']",1,MODERNA,IM 1048842,KY,27.0,F,"fever of 103, chills that lasted hours, nausea and a headache that would not go away.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,OTH,none,none,none,,dairy and beeswax,"['Chills', 'Headache', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1048843,MA,27.0,F,"severe cough, phlegm, severe asthma flare up, headaches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/18/2021,3.0,UNK,,,"asthma, CVID, IBS,",,,"['Condition aggravated', 'Cough', 'Headache', 'Productive cough']",1,MODERNA,SYR 1048844,FL,17.0,F,"Patient is less than 18 years of age when she received vaccine, however EUA is only for 18 years of age and older. No other adverse effects noted other than aches from vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/01/2021,,PVT,,,,,,"['Inappropriate schedule of product administration', 'No adverse event', 'Pain']",1,MODERNA,IM 1048845,PA,51.0,F,"extreme upper body muscle pain, joint burning, involuntary shaking, headache, vomiting, stomach lightning; 14 hour duration; 1,000 mg Tylenol/ 6 hours and ice packs were used; after symptoms subsided slept 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,,,,,,"['Burning sensation', 'Headache', 'Myalgia', 'Tremor', 'Vomiting']",2,MODERNA,IM 1048846,,26.0,F,"Anaphylaxis - tachycardia, palpitations, shortness of breath, skin itching. Received epi pen and ER transport. Now undergoing allergy testing.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/26/2021,01/26/2021,0.0,PVT,,,,,,"['Allergy test', 'Anaphylactic reaction', 'Dyspnoea', 'Palpitations', 'Pruritus', 'Tachycardia']",1,PFIZER\BIONTECH,IM 1048847,MA,58.0,F,"Began feeling unwell around 1 am, with symptoms including uncontrolled chills, generalized body aches, low grade fever 100.1 (baseline always 98.6). Took 600 mg of Ibuprofen around 4 am, and this morning chills and fever have subsided, body aches are starting to minimize, and feeling generally better 9 am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/23/2021,1.0,PVT,"Lisinopril 5 mg, Magnesium 400 mg, Flaxseed Oil 1200 mg all daily",None - felt well.,Well controlled HTN,,NKA,"['Chills', 'Malaise', 'Pain', 'Pyrexia']",2,MODERNA,IM 1048849,WI,60.0,F,"This occurred while EMS was on standby at the COVID vaccination clinic. The patient stated she started getting itchy skin after her COVID vaccination. Her scheduled appointment time was 12:40pm, but she arrived later for her vaccine. Patient asked for Benadryl. Patient did not have any other symptoms besides itching. At 1:38pm the patient assessment was done and vitals taken. Patient HR was 60 and RR was 20, BP was not taken. Patient was given 25 mg oral Benadryl at 1:45pm. Patient was asked to stay an additional 15 minutes for observation, and after that time she felt fine. Patient stated she was staying at work and in her office which was close to the vaccination area. Patient denied further care and transport to",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PUB,Unknown,unknown,unknown,,"strawberry allergy, Erythromycin, Bactrim, Penicillin, Crestor",['Pruritus'],2,MODERNA,IM 1048850,NM,39.0,F,I?m not sure if this is from the vaccine but I have had bad panic and anxiety attacks with elevated heart rate I?ve even visited the ER they did a few tests said I was ok but I?m reporting this because I haven?t had this bad of panic and anxiety in years and want to make sure it?s not affecting me that way,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/27/2021,5.0,OTH,"Multi vitamin , B12, Iron with vitamin c",None,None,,None,"['Anxiety', 'Chest X-ray', 'Electrocardiogram', 'Full blood count', 'Heart rate increased', 'Panic attack', 'Thyroid function test']",1,PFIZER\BIONTECH,SYR 1048851,CT,71.0,F,"About 15 hours after receiving the shot I started to experience nausea, headache, heavy sweating & freezing chills (at the same time), and then this morning about 36 hours after the shot, itching. Took Zomig nasal spray and oxycodone aspirin for the headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/22/2021,1.0,OTH,"Pantoprazole Sodium EC 40mg/take 1 every 3rd day), Oxycodone 325mg (take as needed), Zomig Nasal Spray (take as needed), Ajovy (take 3 doses every 3 months), Baclofen 10mg (take as needed), Betamethasone Dipropionate Cream (use on exzema as",,"Migraines, Hiatal Hernia, GERD, 2 bulging discs in lower back, Diabetes, Sleep Apnea",,"Penicillin, Zocor, Rizatriptan Benzoate, Prozac, Tylenol, Anti-depressants, statins, sulfur drugs, Primecrolimus Cream, Parmesan Cheese, nuts, yeast, ginger, Berberine","['Chills', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pruritus']",1,MODERNA,IM 1048852,NY,52.0,F,"""10min after vaccine, experiencing chest tightness and feeling SOB, BP 124/82 HR 44-86 with abnormal heart rhythm on auscultation O2 sat 100% temp 36.8 . She expresses tingling to the tips of her fingers, left shoulder pain radiated to her neck. DR in urgent care immediately notified and arrived . EKG ordered """,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/05/2021,02/05/2021,0.0,PVT,,,,,,"['Aggression', 'Arrhythmia', 'Arthralgia', 'Body temperature normal', 'Chest discomfort', 'Dyspnoea', 'Electrocardiogram', 'Immediate post-injection reaction', 'Neck pain', 'Oxygen saturation normal', 'Pain']",1,PFIZER\BIONTECH,IM 1048853,AZ,55.0,F,Rash developed this morning on left arm. Doesn?t itch.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/23/2021,11.0,WRK,"Pravastatin, magnesium,centrum silver, fish oil, calcium, Nature?s Bounty immune",None,High cholesterol,,Hydrocortisone,['Rash'],1,MODERNA,SYR 1048854,NY,81.0,M,"Shaking terrible for like 18 hrs about 24 hrs after shot, vomiting, diarrhea, disoriented. A week later he is very weak. Has decided not to do the 2nd shot",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/14/2021,1.0,PVT,,,,"pneumonia Shot- like a bad cold, 75 years old",,"['Asthenia', 'Diarrhoea', 'Disorientation', 'Tremor', 'Vomiting']",1,MODERNA,SYR 1048855,MD,71.0,M,"Delayed cutaneous hypersensitivity (Covid arm). Red rash, warm to the touch at injection site. No treatment required. Occurred 8 days after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/22/2021,9.0,PHM,"Xarelto 20mg, Atorvastatin 10mg, Clonazepam 0.5 mg, Flecainide 50mg x2, Metoprolol 12.5mg, Centrum Silver, Vitamin D 1000iu.",None,"Atrial Fibrillation, Rheumatoid Arthritis,",,None,"['Injection site erythema', 'Injection site rash', 'Injection site warmth', 'Type IV hypersensitivity reaction']",1,MODERNA,IM 1048856,OH,67.0,F,"?COVID arm? 2/20/21 I noticed a 2.5? (diameter) hard mass below injection site. Mass became deep red, painful and itchy. 2/20-2/22/21 I ran a low grade fever, burning eyes, malaise, and significant generalized muscle aches. On 2/21 the mass and redness had become larger 3.5?, remained tender and very red. 2/23, I was no longer febrile and had no extraneous symptoms other than my arm. The area became softer, still tender, redness was a lighter red but more diffuse. 2/24 much better but still noticeable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/20/2021,8.0,PHM,"Levothyroxine, multivitamin, tylenol",None,None,,"Sulfa, Penicillin, Macrodantin, Cipro","['Eye irritation', 'Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site pruritus', 'Malaise', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 1048857,AZ,34.0,F,"This patient is a 34 y.o. female presenting to the emergency department with a chief complaint of anxiety onset 1130. The patient reports that she had her second dose of the COVID vaccine, and 4 minutes after, had chest tightness with palpitations. She had associated nausea, vomiting and a mild headache. She states that her symptoms come in waves and are similar to a panic attack. She has had panic attacks in the past. She reports that she had similar symptoms after her fist dose, but states that they were much more mild.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/31/2021,01/31/2021,0.0,PVT,,,,,,"['Anxiety', 'Chest discomfort', 'Headache', 'Immediate post-injection reaction', 'Nausea', 'Palpitations', 'Vomiting']",2,PFIZER\BIONTECH,IM 1048858,TN,22.0,F,"9:40 am; person reported this person having problems after vaccination of the Moderna Covid-19 vaccine. Experiencing difficulty swallowing; ""feels like a lump in my throat"", headache. Proceeded to her vehicle and assessed, she reports having a little difficulty swallowing and felt a little funny, alert and oriented. BP 120/60, R 12 P62, continued to monitor - BP rechecked at 9:44 am 132/90, R 12 P 66. Pt. complained of itching around face and neck, 9:45 am EMS/911 contacted and Pt. given Benadryl 50 mg/ml 1cc IM to Rt. Deltoid. Pt. developed redness to face/chest and continued to complain of itching. 9:49 am EMS on scene and report given. PT. was able to walk to back of ambulance and enter for further evaluation and treatment as needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PUB,None,None,None,,PCN; Zithromycin,"['Dysphagia', 'Erythema', 'Feeling abnormal', 'Headache', 'Pruritus', 'Sensation of foreign body']",1,MODERNA,IM 1048860,VA,49.0,F,"Pain, tenderness, and swelling near the left collar bone. (Lymph node?)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/22/2021,6.0,PUB,Vitamin D,none,overweight,,PCN,"['Pain', 'Swelling', 'Tenderness']",1,MODERNA,IM 1048861,,52.0,M,"Itchy, erythematous rash. Did not go to ER or get treatment immediately but then saw allergy, received allergy testing and later received 2nd dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/05/2021,01/05/2021,0.0,PVT,,,,,,"['Allergy test', 'Rash erythematous', 'Rash pruritic']",1,PFIZER\BIONTECH,IM 1048862,NY,87.0,F,Patient had trouble breathing after vaccination. Assessed by on-site EMT who determined she could return to home.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/20/2021,0.0,OTH,,,,,,['Dyspnoea'],UNK,MODERNA,IM 1048863,FL,79.0,F,"First dose 4 weeks ago, second dose February 17th, 2021. Time 1000 Redness around injection site. She couldn't move her arm and it was sore when trying to move arm above mid chest. ""Looks like someone sprayed red paint over her"". These sx resolved today however she is still experiencing unbearable itchiness. Caller did mention that she has been having chronic itchiness for what she was taking daily Antihistamines (LORATADINE 5mg) but had d/c it prior to vaccine as she was told that taking antihistamines was not recommended. PCC Recommended to go ahead and take an antihistamine as it is not contraindicated. She usually takes Loratadine and was going to take a 10mg tablet. PCC will fu.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/17/2021,0.0,OTH,Synthroid 75mcg QD,,"Thyroid Cancer (Thyroidectomy 15 years ago), Tumors removed from breast (Benign), Cataract surgery, Rotator cuff surgery.",,,"['Erythema', 'Injected limb mobility decreased', 'Injection site erythema', 'Pruritus']",2,MODERNA,IM 1048864,NJ,75.0,F,"SORENESS, ITCHINESS & MUCH SWELLING. THE TREATMENT I WENT TO THE DOCTOR ON 02/22/2019 AND WAS PRESCRIBE AMOX-CLAV 500-125 MG TWICE A DAY AND TRIAMCINOLONE ACETONIDE CREAM USP",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/18/2021,5.0,PVT,"CRESTOR, ASPIRIN, AND LUMIGAN",ASTHMATIC,ASTHMATIC,,,"['Pruritus', 'Swelling', 'Tenderness']",1,MODERNA,SYR 1048865,IL,70.0,F,"I developed a red, itchy rash at and below the vaccine site after 8 days on my upper right arm. It became itchier after 9 days, it disappeared after 10 and 11 days, and it reappeared after 12 days, spreading to the left upper arm and both thighs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/18/2021,8.0,PHM,"Anastrozole 1 mg, Atorvastatin 20 mg, Fluoxetine 20 mg, Hydrochlorotiaide 25 mg, Amlodipine 5 mg, Metoprolo Such Er 100 mg, Omeprazole 10 mg, Ca 600 mg + D3 500 IU, Women's One Daily Multivitamin - All Daily.",None,"Breast Cancer in 2018, High Blood Pressure for many years, Eyestroke in 2017",,"Penicilin, Codeine, Erythromycin, Darvon, Clinoril, Clindamycin, Ace Inhibitors","['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Rash']",1,MODERNA,IM 1048866,AL,35.0,F,"I started having minor body aches about six hours post vaccine. I woke up that night nauseous and dizzy. I passed out on the way to the kitchen to get water. My husband somehow heard me and helped me back to the bedroom where I passed out again. I was eventually able to get back in bed without passing out, though I couldn't get warm and had severe body aches for most of the night. It was like having a very high fever, only there was no fever. I was clammy, but no fever. Around 4:30 a.m. the 'non-fever' broke and the chills and body aches stopped. I was extremely fatigued for the next two days and felt myself again by the third. The arm in which I received the shot hurt pretty bad Friday too but that was the least of my concerns. I did not seek medical treatment for these symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,UNK,"Lexapro, Spironolactone",,,,,"['Cold sweat', 'Dizziness', 'Fatigue', 'Feeling cold', 'Loss of consciousness', 'Nausea', 'Pain', 'Pain in extremity']",1,MODERNA,IM 1048867,,51.0,F,Palpitations 18 hours after vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/06/2021,01/06/2021,0.0,PVT,,,,,,['Palpitations'],1,PFIZER\BIONTECH,IM 1048868,SD,57.0,F,"developed rash 56 hours after covid vaccine and it lasted 24 hours. Rash was on both legs. she also had fever, chills aches 10 hours after the vaccine and that lasted 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/20/2021,2.0,PVT,"Flonase, Acyclovir, probiotic, optivar",,chronic idiopathic urticaria,,"Clarithromycin, Lurasidone, Cipro, Montelukast","['Chills', 'Pain', 'Pyrexia', 'Rash']",2,PFIZER\BIONTECH,IM 1048869,FL,71.0,F,"Initially, post vaccination on 2/12/21, patient experienced pain, and swelling at the injection site which then resolved. Yesterday on 2/20/21, patient started experiencing discomfort, redness and swelling at injection site (left deltoid). referred patient to primary provider if symptoms worsen",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/20/2021,8.0,OTH,"calcium, MVI",,None,,,"['Injection site discomfort', 'Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,PFIZER\BIONTECH,IM 1048871,AL,60.0,F,"Moderna COVID-19 Vaccine EUA First 24 hours - headache, tiredness, nausea Second 24 hours - chills, headache and tiredness continued",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,WRK,Losartan Calcium Multivitamin plus iron-daily Azo cranberry supplement Cetirizine Estrace vagina cream Trimethoprim Zyrtec,None,"High blood pressure, obesity, colorectal cancer survivor",,"Cipro, Neosporin, Aleve","['Chills', 'Fatigue', 'Headache', 'Nausea']",1,MODERNA,IM 1048872,NM,45.0,F,"Experiencing heightened psychosis with bouts of uncharacteristic anger with no other probable cause. Started calming down 5 days after onset. Peak psychosis at 4 days after vaccine. Still some residual effect today (6 days in), but psychotic symptoms are manageable, as before vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/18/2021,1.0,UNK,"Abilify, Benztropine, Myrbetriq",,"Schizophrenia, anxiety disorder, possible seizure disorder",,"Zithromax, penicillin, sulfa, Trileptal, Haldol","['Anger', 'Psychotic disorder']",1,PFIZER\BIONTECH, 1048874,IL,86.0,M,"Approximately 30 minutes after receiving the vaccination dad had a seizure, and he continued having seizures for 24 hours. He developed a low grade fever of 99.4 for 24 hours. He was very ill for 8 days and has been continuing to recover slowly.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,PVT,"Keppra, Vimpat, Lorazepam, Citralopram",None,"Late effect CVA, Hx seizures",,Lamictal,"['Illness', 'Pyrexia', 'Seizure']",1,MODERNA,IM 1048875,,50.0,F,"Shooting pain down the arm to the finger-tips and up to the neck, cannot lift arm over head. Headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/20/2021,0.0,PUB,Amlodipine,,HBP,,demerol,"['Headache', 'Mobility decreased', 'Pain']",UNK,MODERNA,SYR 1048876,NJ,61.0,F,"nausea, vomiting, headache, tired, chills, pain in injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/30/2021,2.0,OTH,"nausea, dizzy, tired","2nd vaccine shot after 48 hrs I had a 5 hr event of nausea, vomiting, headache, tired which quickly went away",,,sulfa,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,SYR 1048877,FL,66.0,F,"patient claimed that she developed arm pain that radiate to the nick and ear aches after 1 hour from receiving the first dose and pain still occuring 3 days after her first dose. patient denies any allergies. patient is taking synthroid for low thyroid level, lipitor for high cholestrol, and effexor for depression. patient was instructed to take over the counter medication ibuprofen or acetaminophen and to perfom cold compression to help with the pain symptoms,",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,UNK,"synthroid for low thyroid level, lipitor for high cholestrol, and effexor for depression.",,,,,"['Ear pain', 'Neck pain', 'Pain', 'Pain in extremity']",1,MODERNA,IM 1048878,TX,70.0,M,"Fever of 101.6 had chills, headache, dizziness . Just like when i had covid.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/21/2021,02/22/2021,1.0,PHM,NO,NO,NO,,NO,"['Chills', 'Dizziness', 'Headache', 'Pyrexia']",1,MODERNA,SYR 1048879,NJ,42.0,F,"Client stated that her right side burned and was painful on the evening of 2/16/2021. The pain continued and she went to Hospital on 2/19/2021 , and had an ultrasound. She was not admitted. She stated that they said her spleen was inflamed. She will go for follow-up at Dr.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/16/2021,0.0,PUB,Multivitamins,None,None,,"No known allergies to medications, food or products. Seasonal allergies to pollen.","['Burning sensation', 'Pain', 'Splenomegaly', 'Ultrasound scan']",2,MODERNA,IM 1048880,FL,74.0,F,"PT RETURNED TO FACILITY ON 2/23/2021 TO REPORT SYMPTOMS OF REDNESS, WARM TO TOUCH, AND SWELLING AT INJECTION SITE - LEFT DELTOID NOTIFIED PTS PRIMARY PHYSICIAN, SET UP APPOINTMENT FOR 1130 TODAY TO BE SEEN",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,PUB,,,,,LATEX,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",2,MODERNA,IM 1048881,PA,80.0,F,"Patient received vaccine on 2/3/21. Developed headache, fever and red warm rash to injection site on 2/21/2021. Applied ice and took Tylenol. Symptoms starting to resolve today",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/21/2021,18.0,PVT,,,,,,"['Headache', 'Injection site erythema', 'Injection site rash', 'Injection site warmth', 'Pyrexia']",1,MODERNA,IM 1048882,MA,71.0,F,"Vaccine was administered 2/1/2021 at approximately 9am. Due to self reporting of allergic reaction (hives) to Augmentin, patient was monitored on site for 30 minutes. After the monitoring period, she was cleared to go with no issues reported at the time. We were later informed that the patient passed away from a pulmonary embolism on 2/12/2021.",Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,,02/01/2021,02/12/2021,11.0,UNK,,,diabetes,,Augmentin (hives),"['Death', 'Pulmonary embolism']",1,MODERNA,IM 1048883,GA,64.0,M,rash on chest and back,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/10/2021,5.0,UNK,losatain proastatain,none,none,,none,['Rash'],2,MODERNA,SYR 1048884,VA,24.0,F,One week from the vaccine there is a large red welt at the vaccine site. My arm is also very sore and itchy. It?s not serious enough to see a provider but I wanted to document any adverse reactions as the vaccine is still being rolled out.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/22/2021,8.0,PUB,,,,,Sulfa allergy,"['Injection site mass', 'Pain in extremity', 'Pruritus']",1,MODERNA,IM 1048885,MD,52.0,F,"I had light headedness,breaking out severe sweats, nausea and vomited (1). I was transported to ER with a 103.5 fever lasted for 10 days, Covid test, Epipen,swollen lymph nodes(right arm) painful,increased fatigue.During the 10 day period I had went to the ER again 5th day got tested for Covid and rechecked symptoms.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/12/2021,01/12/2021,0.0,MIL,"Coreg, Intresta, Trumesmeride?",,"Congestive Heart Failure Stage 2 Kidney Disease,Complex Migraine",,"Morphine, Diltide, Vancomycin. Lisinopril, Turkey, Peanuts","['Cardiac monitoring', 'Dizziness', 'Fatigue', 'Hyperhidrosis', 'Lymph node pain', 'Lymphadenopathy', 'Nausea', 'Pyrexia', 'Rash', 'SARS-CoV-2 test negative', 'Supraventricular tachycardia', 'Vomiting']",2,PFIZER\BIONTECH,IM 1048886,NJ,70.0,F,"COVID-19 Moderna Vaccine Patient received 2nd dose of Moderna COVID-19 vaccine on 2/15/2021 and developed urticaria the next day. Patient has a history of multiple allergic reactions, came to ED for evaluation of generalized hives after vaccine. Patient denies angioedema, throat swelling, SOB, voice change, difficulty swallowing, fever, chills, chest pain, chest tightness, nausea or vomiting. Patient given famotidine 20 mg, hydroxyzine 50 mg and then discharged at 3:13 am on 2/16/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/16/2021,1.0,PVT,"Vit C, Zinc, Empagliflozinm sitagliptin, levothyroxine, Vytorin",,"thyroid disease, diabetes, hyperlipidemia, colitis, GERD",,"Berries, iodine, latex, ibuprofen, nuts, tomatoes, seafood",['Urticaria'],2,MODERNA,IM 1048887,,31.0,F,"Near syncope, dizziness, unresponsive to sternal rub. RRT called and transported to ER where she regained adequate mentation without intervention.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/22/2021,01/22/2021,0.0,PVT,,,,,,"['Dizziness', 'Presyncope', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 1048888,MN,63.0,F,Sore injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,PVT,Synthroid Restasis Atorvistatin,,,Sore injection site,Flagyl,['Injection site pain'],1,MODERNA,IM 1048889,SC,70.0,M,Injection site slightly swollen and itchy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/21/2021,3.0,PHM,"lasix,, eliquis, metoprolol, cymbalta, acyclovir, revlimid",none,"hemochromatosis, multiple myeloma,",,dofetilide,"['Injection site pruritus', 'Injection site swelling']",2,MODERNA,SYR 1048890,AZ,78.0,F,"approx 6:00pm, front of left leg from knee to ankle went numb. No pain , strange like it fell asleep. After approx 24 hrs later started getting feeling back. Today, 2/23 back to normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,OTH,None,None,Asthma,,"Aspirin, penicillin",['Hypoaesthesia'],2,PFIZER\BIONTECH,SYR 1048891,PA,30.0,F,"started with red and swollen right arm at injection site and symptoms went away; and then redness came back. Pt describes rash as red area without swelling, has improve pain since shot at injection site Rash is located on the; right arm",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,02/10/2021,0.0,UNK,,,,,,"['Injection site erythema', 'Injection site rash', 'Injection site swelling']",UNK,MODERNA, 1048892,FL,42.0,F,"Second vaccine 02/19/2021 1150, first vaccine 01/29/2021@1150; Headache, aching and vomited once",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/21/2021,2.0,SEN,Vitamins,,,Flu,codeine/penicillin,"['Headache', 'Pain', 'Vomiting']",2,PFIZER\BIONTECH,IM 1048893,PA,52.0,M,Patient states he had pain at the injection site initially but no further issues immediately after vaccination. He states that approximately 7-10 days after vaccination he developed significant pain of L arm and weakness in radial nerve distribution. He was diagnosed with radial nerve neuropathy and began on treatment with Neurontin and NSAIDs. Symptoms have improved significantly but not yet fully resolved.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/01/2021,7.0,PVT,Denies,Denies,Denies,,Denies,"['Asthenia', 'Injection site pain', 'Radial nerve injury']",1,MODERNA,IM 1048894,VA,44.0,F,"patient had itching of hands My symptoms were were primarily mild itching in the palms and throat and a rash on my chest and hands (was wearing a jacket and mask). On an itching scale of 1 to 10, I told them 2 to 3. According to my nurse, the rash on my chest and hands seemed to peak around 15-20 minutes after (not crimson) and when I finally got to go to the bathroom at the one hour mark and check myself in the mirror",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,PVT,"Zyrtec in am, Flonase Takes Zyrtec / Pepcid",None,"intermittent asthma, vasomotor rhinitis, sciatica, bilateral nodular corneal degeration",,"avelox, gapapentin, gadavist, Sulfa, IV contrast - rash, contrat Singulair - diarrhea Codeine , vicodin- nausea Foods - not IgE mediated because testing negative but cannot peanuts / walnuts","['Pruritus', 'Rash', 'Throat irritation']",1,PFIZER\BIONTECH,IM 1048895,TN,31.0,F,Circular but splotchy rash a site of injection. Appeared 10 days after receiving the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/23/2021,22.0,PUB,Prenatal vitamins,None,None,,None,['Injection site rash'],1,MODERNA,SYR 1048896,VA,86.0,F,"HAD SHOT IN LEFT ARM - AT 6:00PM LEFT HAND WENT NUMB. AT 8:00 HAD SEVERE CHILLS & HIGH TEMPERATURE WHICH LASTED FOR 24 HOURS. HUGE BODY PAIN & COULD NOT MOVE ANYTHING. NECK & HEAD HURT SO BAD I COULDN'T STAND TO MOVE. I COULDN'T LIFT ARMS TO DRINK WATER. SON TOOK CARE OF ME ALL DAY THE DAY AFTER THE SHOT. HAD BRAIN FOG. COULDN'T THINK WHAT I WANTED TO DO OR WHAT I WAS DOING. LASTED FOR A WEEK. AFTER A WEEK I TRIED TO DO MY USUAL WORKING OUT ROUTINE, BUT WHEN I TRIED TO RIDE THE ELLIPTICAL I BROKE OUT IN A HUGE SWEAT AN ALMOST PASSED OUT. THAT LASTED UNTIL 2/22/21, WHICH WAS YESTERDAY, WHEN I WAS FINALLY ABLE TO RIDE ELLIPTICAL WITHOUT ANY ADVERSE REACTIONS. (I'M 86, BUT A VERY ACTIVE 86. I PLAY TENNIS 2 TIMES A WEEK & WHEN WEATHER IS NICE I RIDE MY BIKE FOR 15 MILES A COUPLE TIMES A WEEK.) LIFT WEIGHTS 3 TIMES A WEEK AFTER RIDING ELLIPTICAL FOR 45 MINUTES. NOT A TYPICAL 86 YEAR OLD PERSON.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/23/2021,11.0,UNK,OLMESARTAN MEDOXOMIL 40 MG TAB,NONE,NONE,,DDICLOFENAC - VOLTAREN - AVALIDE - MICARDIS- CONTRAST DYE - MECLIZINE - CIPRO A LOT OF SPICES - JUST AVOID EATING SPICY FOODS.,"['Chills', 'Depressed level of consciousness', 'Feeling abnormal', 'Headache', 'Hyperhidrosis', 'Hypoaesthesia', 'Mobility decreased', 'Neck pain', 'Pain', 'Pyrexia']",UNK,MODERNA, 1048897,,81.0,F,Shortness of breath and chest pains immediately after administration. Transported to hospital. Outcome unknown.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,UNK,,,,Swelling/itching after influenza vaccine,,"['Chest pain', 'Dyspnoea', 'Immediate post-injection reaction']",1,PFIZER\BIONTECH,IM 1048898,CA,35.0,F,Arm redness and soreness at injection site 7 days after receiving injection. Also shoulder sourness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/22/2021,6.0,UNK,Na,Na,Na,,Penicillin,"['Arthralgia', 'Injection site erythema', 'Injection site pain']",1,MODERNA,SYR 1048899,,38.0,F,Itching within 1 hour of vaccine. Has appointment with allergy to evaluate if she should get 2nd.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/20/2021,01/20/2021,0.0,PVT,,,,,,['Pruritus'],1,PFIZER\BIONTECH,IM 1048900,AR,75.0,F,"Face swelling, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,WRK,"Diltiazem,Biotin,Calcium,Vitamin D3,Metamucil,Collagen,Emergen-C",,High blood pressure,,"Dust mites,mold, tomatoes","['Chills', 'Swelling face']",2,PFIZER\BIONTECH,SYR 1048901,AZ,64.0,F,"Fatigue, muscle aches, chills, fever, nausea, diahrea, vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/21/2021,02/22/2021,1.0,OTH,Wellbutrin,No,Asthma,"Chills fever from Shingrix, 64 years old, in 12/20",No,"['Chills', 'Diarrhoea', 'Fatigue', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 1048902,NY,28.0,F,Headache fever body ache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/22/2021,21.0,PVT,N.a,Type 1 diabetes,Type one diabetic,,N.a,"['Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1048903,PA,46.0,F,"Initially, about 24 hours after vaccination, redness, pain and swelling, hot to touch - felt chills for about 12 hours. Redness spread to an area of about 3 inches. The next morning, I felt fine. Through the week, this area faded but did not disappear completely. About a week later, on Sunday, Feb 21, the area on my arm grew to around 6 inches or more: red, swollen, itchy, warm to the touch, worse than the week before. I saw my family doctor on Monday, Feb 22 and they determined it was not infected, just a local histamine reaction. They advised Benadryl and a topical steroid to deal with symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/21/2021,8.0,SEN,"Vitamin D, Zinc, Vitamin C, Metoprolol 25 mg, Fluorouracil cream",None,High Blood Pressure,,No Known,"['Chills', 'Erythema', 'Local reaction', 'Pain', 'Peripheral swelling', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,IM 1048904,FL,17.0,F,Patient received vaccine at age 17 of age even though EUA is for 18 years of age and older. No adverse effects noted.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/01/2021,,PVT,,,,,,"['Inappropriate schedule of product administration', 'No adverse event']",1,MODERNA,IM 1048905,FL,23.0,F,Night after vaccine: extreme muscle pain 2 days later: supraclavicular and anterior cervical lymphadenopathy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/16/2021,1.0,OTH,Lexapro 10 mg Claritin 10 mg Flonase,None,None,,NKDA,"['Lymphadenopathy', 'Myalgia']",1,PFIZER\BIONTECH,IM 1048906,,74.0,F,"noticed redness at both sides waist on 2nd day, it kept spreading until both sides of my ankles, back of knees, and buttocks and inside of thighs were also covered with a rash, small red dots and or a welt .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/10/2021,2.0,UNK,,,,,,"['Blood count', 'Erythema', 'Rash', 'Rash erythematous', 'Urticaria']",1,MODERNA, 1048907,KY,81.0,F,Diahrrea and extreme stomach pain off and on for almost 2 weeks Still after almost 2 weeks very red but no swelling at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/15/2021,5.0,PVT,Prenatel plus Omeprazole Vitamin D3 B-12 Calcium Aspirin 81 Metoprolol Warfarin Levothyroxine,,Congestive heart failure History of blood clots Mitral valve narrowing,,,"['Abdominal pain upper', 'Diarrhoea', 'Erythema']",UNK,MODERNA,SYR 1048908,NJ,44.0,F,Migraine headache 3 hours post shot. Headache each morning since. Resolves with 800IB,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,PUB,Vyvanse 40mg Claritin Singulair,No,None,,No,"['Headache', 'Migraine']",2,MODERNA,IM 1048909,IN,64.0,F,"Part of the vaccine ran out at time of injection. The night of the injection my arm started itching. I was awakened at 4;00 a.m. the next morning with a very stiff, sore, cramping arm. I had the normal reactions: slight headache, low temp, itchy, swollen, hot red arm, but very stiff and sore. This lasted 3-4 days with the most noticeable reaction being the sore arm from shoulder to elbow. On Feb 10, one week later, my arm started itching again in the afternoon and by evening was swollen, red, hot, and hurting just like the first 3-4 days or slightly worse. It gradually got better after 4-5 days, returning to normal by 2/20. The only other symptom the second time were blisters on my left hand above my pointer finger and ring finger. I'm not sure if they were related or not since I walk outside or if I may have been exposed to poison ivy since the blisters looked similar.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/10/2021,7.0,OTH,Lipitor 20 mg; Femring .10 mg; Multi Vitamin Centrum; PreserVision; Vitamin D3 2000 iu,None,None,,Sulpha drugs,"['Blister', 'Erythema', 'Headache', 'Injection site extravasation', 'Muscle spasms', 'Musculoskeletal stiffness', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Pyrexia', 'Skin warm']",1,MODERNA,IM 1048910,PA,59.0,M,Patient received his second dose of Moderna COVID19 vaccine on 2/22/21. Patient was given 1ML instead of 0.5ML. Patient monitored no adverse event noted during observation.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PVT,unknown,unknown,unknown,,unknown,"['Incorrect dose administered', 'No adverse event']",1,MODERNA,IM 1048911,NC,75.0,F,"Large swelling at injection site, redness, iching",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,PUB,"Spriva, Dulera, Clopidogrel, Amlodipine-Besylate",,"COPD, Hipertension",,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",2,MODERNA,IM 1048912,NJ,57.0,F,"Received 2/16 had sore arm that day starting wishing a few hours. 2/17 had a sore throat that lasted several,days and still today isn?t perfect 2/23. Thursday around 8:30 pm I noticed a full body lumpy hive type of rash. It wasn?t really itchy so I?m not betta in exactly when it started. I took Benadryl at time of seeing it and contacted my doctor. I had a virtual visit and they prescribed prednisone for 5 days which I finish today. The rash lessened by Friday around 6pm and was mostly gone by Saturday when I woke up. I am having allergy testing and taking Claritin daily as my throat still at times feels itchy. I did finish an new antibiotic the morning of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,UNK,"Synthroid and Macrobid morning of vaccination Daily is protonix, olmesartan, synthroid, lorazepam, verapamil and most days Claritin",A uti that was being treated by macrobid from 2/12 finish 2/16,"Hypothyroid, pVC?s",,"Suspected shellfish, cashews, I am currently being tested and skin test shows negative. Awaiting blood test Cefdenir, bactrim","['Allergy test', 'Oropharyngeal pain', 'Pain in extremity', 'Rash', 'Throat irritation', 'Urticaria']",UNK,MODERNA,SYR 1048913,KY,22.0,F,"Patient complained of ""tongue feeling heavy"" and ""itching in roof of mouth"". 25mg PO Benadryl given at 1444 on 2/22/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,OTH,,,,,NKDA,"['Oral pruritus', 'Paraesthesia oral']",1,MODERNA,IM 1048914,NJ,63.0,M,"Developed pruritic rash that began approximately 48 hrs after vaccination and lasted 1 week then resolved. He had bloodwork done 48 hrs after vaccination prior to giving blood. He was told that he was ""positive for HIV and leukemia"" based on that bloodwork. He was then seen by PCP and had repeat labs which were normal. He denies any further symptoms. The PCP attributed the false positive lab results to having the COVID vaccine 48 hrs prior to initial labwork.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/22/2021,2.0,PVT,,,,,,['Rash pruritic'],1,MODERNA,IM 1048915,FL,61.0,F,"Patient describes rash as big blotches that are red, big circles, a little white in the middle, in some areas red with some bumps, feel inflamed, and hot. Rash is on patients stomach, arms, legs, says that last night ears were inflamed; Rash started on site of vaccine about 2-3 days after, PT put hydrocortisone cream on it and rash went away, rash came back about February 16th and has progressively worsened",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,,,UNK,,,,,,"['Injection site rash', 'Rash', 'Rash maculo-papular']",2,MODERNA,IM 1048916,,29.0,M,"Fever, severe chills, aches, severe fatigue. Onset 12 hours after dose. Resolved 24 hours after onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,MIL,,,,,,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",2,MODERNA,IM 1048917,MN,92.0,M,"Resident yelling for assistance in apartment. Nursing personnel found resident on floor at 6:10 AM on 2/18/2021. Resident was transported to Hospital on 2/18/2021. Status update on 2/18/2021 from son, resident CT & X-rays were done all normal. Labs done and WBC count was elevated and awaiting results. Resident stable and admitted to hospital for observation. Resident passed away on 2.21.2021.",Yes,02/21/2021,Not Reported,Yes,4.0,Not Reported,N,02/17/2021,02/18/2021,1.0,SEN,"Aspirin 81 MG EC tablet 1 daily, Latanoprost 0.005% Ophth Soln, Incruse Ellip 62.5MCG/ACT Inh, , Losartan 25 MG tablet, Ompeprazole 20 mg, Potassium CL 20 MEQ ER tablet, Preservision Areds Tablet, Simvastatin 40 MG tablet,",No acute illness,"Diagnosis Codes obtained upon admission in 11.17.2015 I45.10, J30.9, J44.9, E78.0, i10, K21.9, H40.9, D69.6, G93.40, K59.0, Z96.641, sm869, sm859",,"Morphine, Shellfish","['Computerised tomogram normal', 'Death', 'Fall', 'Laboratory test', 'White blood cell count increased', 'X-ray normal']",UNK,MODERNA,IM 1048918,FL,74.0,M,He started not feeling right about four hours after getting vaccine. First took blood pressure about 5pm. At that time it was 148/72. About 1/2 hour later it went to 160/76. About 8pm it was 177/90. He took Lisinopril 20mg. By about 10pm it had gone up to 198/98 and he took Nitroglycer .4mg. At this point we went to the Emergency Rm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PVT,"Folbic, Aspirin 81mg, Atorvastatin 20mg, Famotidine 40mg, Xarelto 15mg, Ropinirole .5",none,heart disease,,"dairy productions, certain contrast dye","['Blood pressure increased', 'Blood test', 'Electrocardiogram']",1,MODERNA,SYR 1048919,,37.0,F,Flushing and headache,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/19/2021,01/19/2021,0.0,PVT,,,,,,"['Flushing', 'Headache']",1,PFIZER\BIONTECH,IM 1048920,AR,69.0,F,"Chilblains toes, both feet",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/23/2021,3.0,PVT,Multi vitamin,,,,,['Chillblains'],UNK,PFIZER\BIONTECH, 1048921,FL,16.0,F,Patient received vaccine at 16 years of age however EUA is indicated for 18 years of age and older.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/01/2021,,PVT,,,,,,['Product administered to patient of inappropriate age'],1,MODERNA,IM 1048922,PA,86.0,F,A week after shot. The area became red and raise about the size if a women's hands and its still like that.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/17/2021,7.0,PHM,blood pressure meds,,,,iodine,"['Injection site bruising', 'Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 1048923,AL,88.0,M,"Moderate Pain in Right arm and upper body, fever of 100.8, treated with Tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/23/2021,1.0,PUB,"Baby ASA, Centrum Silver, Amlodipine, Carvedilol, Citalopram, Diazepam, Omeprazole, Tamsulosin, Trazodone, Align Probiotic",,,,,"['Pain', 'Pain in extremity', 'Pyrexia']",2,MODERNA,SYR 1048924,FL,87.0,M,"Dime size red circle and swelling with white dots; Referred to pcp; Follow up with patient. Patient stated that the swelling at injection site went down in size. Injection site no longer itches. patient has been taken tylenol for minor site pain, he stated that his pain level is currently 0/10. Patient also stated that he used over the counter hydrocortisone cream on the injection site. Which he believes has helped with the itching. Patient was instructed to continue to monitor the site and to call back with any other injection related problems.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/15/2021,02/17/2021,2.0,PVT,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",2,MODERNA,IM 1048925,IL,40.0,F,"Headache, Fever, Body/joint Ache, Fatigue the day after, with fatigue and body/joint aches and slight headache for the following days in decreasing intensity. Rash on upper arm appearing 9 days after, increasing in size daily.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,OTH,"Nuvaring, vitamin C, vitamin D, Hair skin and Nails, Florastor, Zyrtec",,,,Seasonal,"['Arthralgia', 'Condition aggravated', 'Fatigue', 'Headache', 'Pain', 'Pyrexia', 'Rash']",UNK,MODERNA, 1048926,,34.0,M,"Evening of 2/19, developed chills, 100.1 fever, fatigue, lasted for 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,UNK,,,,,,"['Chills', 'Fatigue', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1048927,TX,59.0,F,1/19/2021 heavy arm sore injection sight for 24 hours 2/13/2021 Shingles,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/23/2021,0.0,PVT,Levothyroxin 88mcg,None,None,,None,"['Herpes zoster', 'Injection site pain', 'Limb discomfort']",1,MODERNA,IM 1048928,VA,56.0,M,"Tiredness, shaky feeling, chills, mild lymph node swelling, low grade fever(<=99degreesF), loss of appetite. Treated w/ bed rest, water, and ibuprofen. Lasted three days after shot. Fourth day, no fever, no swollen glands, and appetite returning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,SCH,"Fluconazole, Tamsulosin, Finasteride, Calcium Citrate w/Vitamin D, Glucosamine/Chondroitin, Men's 55+ multi-vitamin, Co-Q10, Fish oil, Allegra 24hr",none,"Mild cold-induced asthma, Back/neck injuries, Sinus dryness-post sinus surgery 2 years ago",,Ciprofloxacin,"['Chills', 'Decreased appetite', 'Fatigue', 'Lymphadenopathy', 'Pyrexia', 'Tremor']",2,PFIZER\BIONTECH,SYR 1048929,TX,60.0,F,FEELING FLUSH IN FACE FEELING DRYNESS IN MOOUTH AND THROAT FEELING THICKNESS IN THROAT ( CLIENT EVALUATED BY CLINIC DOCTOR AND SYMPTOMS SUDSIDED IN 15 MINUTES),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2012,02/10/2021,3288.0,PUB,none,none,none,,none,"['Dry mouth', 'Flushing', 'Oropharyngeal discomfort']",6,MODERNA,IM 1048930,FL,27.0,F,"started: 1-19-21 at approx 7pm, rash to left arm below injection site, reports it raised and hot to touch",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/19/2021,7.0,PUB,,,,,,"['Injection site rash', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 1048931,,55.0,F,"Patient phoned EHS on 2/22 and inquired about her side effects and how long they should be lasting? Patient experiencing ha, and pain at injection site. Patient states it is getting better, but still voiced her concerns. Education provided of side effects vs illness and side effects lasting 7 days, follow up with PCP Dr. for further advice, and if patient continues to have symptoms after 7 days, phone EHS back for further evaluation. Patient agrees to above plan of care. EHS filled out RL6 for pt.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,PVT,,,,,,"['Headache', 'Injection site pain']",UNK,PFIZER\BIONTECH, 1048932,CO,39.0,F,"Swollen area around injection site, hardness, hot to touch and very sore. Redness on entire upper arm. Symptoms didn?t appear until day 8-9. Extreme fatigue, muscle soreness in whole body.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PVT,"Bystolic, lorazepam, Claritin, probiotic, daily multivitamin","Rhinovirus, confirmed negative Covid test","High blood pressure, anxiety",,Benadryl,"['Erythema', 'Fatigue', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Injection site warmth', 'Myalgia', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 1048933,NC,70.0,M,"1st dose February 2, 2012 Pfizer lot# EL8982, 2nd dose February 20, 2021 Pfizer lot# EN6203 Symptoms: February 21, 2021 - 24 hours of mild diarrhea, chills, muscle aches, no fever All symptoms gone by February 22, 2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,OTH,none,none,"24 hours of mild diarrhea, chills, muscle aches, no fever",,none,"['Chills', 'Diarrhoea', 'Myalgia']",2,PFIZER\BIONTECH,IM 1048935,FL,46.0,F,"After my second dose vaccine, I woke up with body aches, headaches, chills, fever, I felt like I had the flu. I took my temperature it was 101.6F. The following day, my fever was 102.6F and still felt fatigued, joint aches, chills, severe headaches and could not read a book due to the headaches. Throughout the day, still had the fever and it was 100.7F and I had tons of fatigue, sweating with severe headaches, body aches, I had these symptoms for a total of 10 days. The following Monday 02-01-2021, I did a Covid-19 test which was negative and I resumed back to work on 02-03-2021. For my 1st vaccine dose which I received 12-29-2020 my symptoms were not as bad as the second dose and I experienced fatigue, headaches and one week later I was diagnosed with shingles and a rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/26/2021,1.0,WRK,"Effexor 150mg BID, Clonazepam 1mg at bedtime, Belsomra 20mg at bedtime, Atanolol 25mg OD, Zertec 10mg OD, OTC Tylenol",,"Anxiety, Depression, interstitial cystitis, Lichen sclerosis",,"Latex, Tetracycline, Aspirin, Aleve","['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Influenza like illness', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative']",2,MODERNA,IM 1048936,IL,57.0,F,Imbalance and confusion,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/27/2021,01/27/2021,0.0,SEN,,,,,,"['Balance disorder', 'Confusional state']",2,PFIZER\BIONTECH, 1048937,PA,47.0,F,rapid heart rate exhaustion fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,UNK,,,,,Sulfa drug allergy,"['Fatigue', 'Palpitations', 'Pyrexia']",2,MODERNA, 1048938,,34.0,F,"On Saturday morning I woke up with a headache and swollen lymph nodes in my neck/collarbone area. As the day progressed, I began to have pain in my joints and muscles. I felt very tired all day as well. I also experienced skin sensitivity which basically just made my skin hurt if anything/one touched me. Sunday my headache persisted, still had pain at injection site and felt warm to the touch. Swollen lymph nodes also still there and fatigue. Monday morning symptoms of headache, injection site pain and warmth and swollen lymph nodes still felt. Taking Tylenol to help with headache, warm compresses to help swollen lymph nodes and ice pack for injection site pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/20/2021,1.0,PVT,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site warmth', 'Lymphadenopathy', 'Myalgia', 'Pain of skin', 'Skin sensitisation']",UNK,PFIZER\BIONTECH, 1048939,OH,72.0,F,"Patient called and complained that on day 7 after reciving the vaccine, she experienced a tennis ball size itchy red spot at the vaccine site. She said that it is still persistent at day 8.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/15/2021,02/22/2021,7.0,PHM,N/a,,,,N/a,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 1048940,IN,77.0,F,"Chills, fever, body aches, and headache for approximately 24 hours. Site of injection had a hard knot and inflamed for days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PVT,"Hydrochlorothiazide, 25 mg, Atorvastin 10mg, Vitamin D3",,,,codeine,"['Chills', 'Headache', 'Injection site induration', 'Injection site inflammation', 'Pain', 'Pyrexia']",2,MODERNA,SYR 1048941,NY,51.0,M,right sided bells palsy for 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,PVT,Briveracetam Zonegran Pravastatin Omeprazole Mens One a day 50+ Vitamon D 5000Iu Tamsulosin Ibuprofen 800mg Cyclobenzaprine,none,"Generalized Seizure disorder, hyperlipidemia, Chrons disease, GERD",,"Dilantin, aspirin, tegretol, bactrim, fentanyl, versed, CT dye, Penicillin",['Facial paralysis'],2,MODERNA,IM 1048942,OH,80.0,M,"Patient received his 2nd dose of Moderna Covid-19 vaccine, and approximately 5-10 minutes after receiving, while in the observation area, he lost conciousness while sitting up on the bench. Epi- Pen was administered and EMS arrived within 5 minutes, and transported him to the Clinic. At the time of EMS arrival, the patient was conscious.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/22/2021,02/22/2021,0.0,PHM,unkown,,Per patients spouse he was a heart failure patient,,,['Loss of consciousness'],2,MODERNA,IM 1048943,GA,52.0,F,"Headache, Redness in the injection site, fever, chest pain, Tachycardia, weakness, fatigue, muscle pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,OTH,None,,Sjogren's Syndrome (Stable) The rheumatologist recommend I get the COVID-19 Vaccine,First dose of COVID-19 vaccine but less intense than the second dose. I submitted the online form and never received a contact b,None,"['Asthenia', 'Chest pain', 'Fatigue', 'Headache', 'Injection site erythema', 'Myalgia', 'Pyrexia', 'Tachycardia']",2,MODERNA,IM 1048944,MT,62.0,F,"Headache, Body aches, Chills, Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/20/2021,2.0,PVT,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pain']",2,MODERNA,IM 1048945,FL,68.0,M,"2/1/21 first , 2/18/21 second first 2/1/21 , fever started 2/19/21 am 103 temp. earlier, 102.7 temp. now ( has taken no meds so far) Advised to take apap or ibuprofen to keep temp < 101",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,OTH,losartan,,hypertension,Bacrin- 50yrs ago red skin,,['Pyrexia'],2,PFIZER\BIONTECH,IM 1048946,WI,79.0,F,"Difficulty breathing as a result of swelling back of nose, diarreha, nausea,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/13/2021,1.0,PVT,"Clonidine, Trazadone,Tolter0dine Tartrate,Ropinirole Hcl, Omeprazole, Olanzapine, Metformin HCL, Lovastatin,Fluvoxamine Maleate, Cevimeline HCL, Alparazolam, Womens 50 plius vitamin, Polethylene glycol,Melatonin,Loratadine, Glucosamine Cho",None,"Major Depression, Obsesvive compulsion D., Borderline Diabetes, Barretts,",,"Sulfa, Cipro,","['Diarrhoea', 'Dyspnoea', 'Nasal congestion', 'Nausea']",2,MODERNA,IM 1048947,VA,83.0,M,Patient experienced an episode of emesis and loss of consciousness several hours after vaccine on 2/16/21. He was taken by EMS to the hospital and was noted to be hypoxic and hypotensive. He was admitted to the hospital and subsequently intubated. He was also found to have a small bowel obstruction and a nasogastric tube was placed to decompress the bowel. He required pressor support as well. He expired on 2/17/21.,Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,,02/16/2021,02/17/2021,1.0,PVT,Oxybutinin Carvedilol Eliquis allopurinol atorvastatin losartan amiodaron furosemide ezetimibe zofran,,End stage renal failure on dialysis Hospitalization on 2/5/21 for ESRD and initiation of hemodialysis Anemia of chronic disease Chronic atrial fibrillation on anticoagulation Congestive Heart failure Recurrent abdominal wall hernia,,keppra decadron,"['Death', 'Endotracheal intubation', 'Gastrointestinal tube insertion', 'Hypotension', 'Hypoxia', 'Loss of consciousness', 'Small intestinal obstruction', 'Vomiting']",1,MODERNA,IM 1048948,UT,82.0,F,"On Sunday the 2/21/2021, about 3PM I noticed that the area where I received the vaccination was red, swollen, itching, and sore. I googled search and found it was a rare but real reaction vaccine, called COVID ARM. According to the information I read it occurs between 7-9 days after vaccination. Mine occurred exactly 7 days later. I have been putting Hydrocortisone cream with Aloe in it and on it. Today it is more sore then itching and still red. The Hydrocortisone with Aloe seemed to help. I have also noticed my eyes have been watering a lot more since receiving the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/21/2021,7.0,PHM,"Lexapro 20 MG daily, Eye Drops Xalatan one drop in each eye daily, Valium 1/2 tablet twice a day as needed, Vagifem cream internally twice a week. Vitamin C, Vitamin B-12, Vitamin D, Folic Acid, Cranberry pill, Multi-vitamins Women's, Pro",,,,Penicillin,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Lacrimation increased', 'Skin reaction']",1,MODERNA,SYR 1048949,WI,29.0,F,"fever, diarrhea, lethargic x 12 hrs , vaginal spotting and pelvic cramping x 2 weeks",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/23/2021,1.0,MIL,Lessina Oral Birth Control,None,None,,None,"['Diarrhoea', 'Lethargy', 'Pyrexia', 'Uterine spasm', 'Vaginal haemorrhage']",1,MODERNA,IM 1048950,MD,34.0,M,"Body aches, chills, fever, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,WRK,Zoloft,,,,"Apples, pollen","['Body height', 'Chills', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1048952,LA,43.0,F,"Developed excruciating pain in back, unable to take deep breaths, severe headache, and legs weak. Instructed to report to ER or Urgent care. She went to an ER, but did not stay due to long wait. Symptoms subsided on their own.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/21/2021,2.0,OTH,none,none,none,,none,"['Back pain', 'Dyspnoea', 'Headache', 'Muscular weakness']",UNK,MODERNA,IM 1048953,VA,65.0,M,Received vaccine 2/17/21. On 2/20/21 began to have sever L foot pain that continues on day reported (2/24/21).,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/20/2021,3.0,PVT,Unknown,Unknown,Unknown,,Unknown,['Pain in extremity'],1,MODERNA,IM 1048960,TX,,F,"Injected with a long needle that hit her bone; Most of the content of the syringe spilled out; Most of the content of the syringe spilled out; A spontaneous report was received from a consumer concerning a female patient of unknown age. The patient had her second dose of the vaccine and she was injected with a long needle that hit her bone and while the nurse who was administrating the vaccine tried to pull out the syringe, most of the content of the syringe spilled out. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (batch number not provided) on an unknown date. The patient received their second of two planned doses of mRNA-1273 (batch number not provided) in the for prophylaxis of COVID-19 infection. The agent said the patient had her second dose of the vaccine and she was injected with a long needle that hit her bone and while the nurse who was administrating the vaccine tried to pull out the syringe , most of the content of the syringe spilled out. She is not sure if she needs to get another short or not. Treatment information was not unknown. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the events was unknown.; Reporter's Comments: This report refers to a case of wrong technique in device usage process, underdose, and device connection issue for mRNA-1273 (lot# unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Device connection issue', 'Underdose', 'Wrong technique in device usage process']",2,MODERNA,OT 1048961,CA,81.0,M,"Stroke; A spontaneous report was received on 09 FEB 2021 from a consumer concerning an 81-year-old, male patient who received Moderna's COVID-19 vaccine and experienced stroke. The patient's medical history provided were, Alzheimer and Parkinson's disease. No relevant concomitant medications were reported. On 28 JAN 2021, patient received their first of two planned doses of mRNA-1273(Batch number 027L20A) injection for the prophylaxis of COVID-19 infection. On 03 FEB 2021, within 7 days of receiving vaccine, patient experienced a stroke. On 03 FEB 2021, patient was admitted to hospital. Patient was due for his second shot of Moderna's COVID-19 vaccine on 26 Feb 2021. Patient's hospital can only provide Pfizer's vaccine and not Moderna's COVID-19 vaccine. But patient wanted to get Moderna's COVID-19 vaccine. Patient's wife wanted to know the way she could arrange the administration of the Moderna's COVID-19 vaccine in the hospital for her husband. Treatment for the event was not provided. � Action taken the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, stroke, was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. However, patient's elderly age is considered a risk factor.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/28/2021,02/03/2021,6.0,UNK,,Alzheimer's disease; Parkinson's disease,,,,['Cerebrovascular accident'],1,MODERNA,OT 1048962,MA,,M,"vaccine administered to 17 year old; A spontaneous report was received from a nurse concerning a 17-year- old male patient, resulted in the event of inappropriate age of dose of administration. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 012L20A) on 20 Jan 2021, in left arm for the prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient received vaccine who was under the age of 18 years old. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, resulted in the event of inappropriate age of dose of administration, was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number 012L20A) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/20/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA, 1048963,NM,,U,"Vial dropped from 4 ft to the floor and doses were administered; A spontaneous report was received from a consumer concerning a patient (no gender or age information provided) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: vial dropped from 4 feet to the floor and doses were administered. The patient's medical history was not provided. Concomitant product use was not reported. On 10 Feb 2021, prior to the onset of the event, the patient was administered a dose (unknown if dose 1 or dose 2) of mRNA-1273 (Lot #: unknown, arm/location unknown) for prophylaxis of COVID-19 infection. On 10 Feb 2021, at the facility where the reporter was volunteering, an unpunctured vial was dropped from approximately 4 feet to the floor but the vial did not break. The reporter argued with the doctor that the vial should not be used per his understanding that administration instructions say to ""Swirl gently after thawing and between each withdrawal. Do not shake."" The reporter was concerned as the vial got shaken up instead of swirled when it was dropped from the 4 foot height. The doctor still asked the nurse to use that vial. No lot number or expiration date was available. There was no product available to retrieve as that vial was administered that day. Action taken with mRNA-1273 in response to the event was unknown. The event, vial dropped from 4 feet to the floor and doses were administered, was considered resolved.; Reporter's Comments: This report refers to a case of Product preparation issue for mRNA-1273 (lot # unknown) with no associated adverse events. The vial was dropped from 4 feet to the floor and doses were administered. Event occurred the same day as vaccine administration. Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,02/10/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Product preparation issue'],UNK,MODERNA,OT 1048964,PA,16.0,M,"16-year-old received the first dose of Moderna Covid-19 by accident; A spontaneous report was received from a consumer concerning a 16-year-old, male patient who received the first dose of Moderna COVID-19 vaccine (mRNA-1273) by accident/MedDRA PT: Product administered to patient of inappropriate age. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 013L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 13 Jan 2021, the patient received first dose of Moderna COVID-19 vaccine by accident. Action taken mRNA-1273 in response to the event was unknown. However, it was reported the patient was taken to receive the second dose of Moderna COVID-19 vaccine but was denied to him because he was a minor The event, 16-year-old received the first dose of Moderna Covid-19 by accident, was resolved on 13 Jan 2021.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273 (Lot # 013L20A) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1048965,CT,16.0,M,"dose to a 16 year old; A spontaneous report was received from a healthcare professional (HCP) concerning a 16-year-old, male consumer who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No relevant concomitant medications were reported. On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. On 14 Jan 2021, a 16-year-old patient was administered the first dose of the Moderna vaccine. No other information was received. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was unknown. The event, vaccine given to a patient less than 18-years-old, was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old male) for mRNA-1273 (lot number 013L20A) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1048966,MA,17.0,M,"underage son received Covid vaccine; A spontaneous report was received from the mother of a 17 year old male patient. The patient's medical history was not provided. No relevant concomitant medication was reported. On 02 Jan 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. The patient was 17 tears old (underage). No treatment information was provided. Action taken with the mRNA-1273 was not reported. The outcome of the event, product administered to patient of inappropriate age, was considered resolved on 02 Jan 2021.; Reporter's Comments: This case concerns a 17 year old male who received their first of two planned doses of mRNA-1273 (Lot number: unknown intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1048967,,66.0,F,"Some of the vaccine leaked down her right arm; A spontaneous report was received from a consumer concerning a 66-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) and the vaccine leaked down her right arm. The patient's medical history was not provided. Concomitant product use was not provided. On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013L20A) for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 309K20A) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection and the vaccine leaked down her right arm. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The event vaccine leaked down her right arm was considered resolved.; Reporter's Comments: This case report concerns a non-serious unexpected event of a 66-year-old female patient who experienced vaccine leaked down her right arm (Incomplete dose administered) for mRNA-1273, lot # 309K20A. There were no reported AEs associated with this case of incomplete dose administered",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Incorrect dose administered'],2,MODERNA,OT 1048968,NY,,F,"A patient had the vaccine running down her arm after administration; most of that vaccine came pouring down arm; A spontaneous report was received from a pharmacist, concerning a 28-year-old, female patient, who received Moderna's COVID-19 vaccine and a patient had the vaccine running down her arm after administration/ underdose. The patient's medical history was not reported. No relevant concomitant medications were reported. On an unknown date, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for COVID-19 infection prophylaxis. On an unknown date, the pharmacist reported that a patient was administered the vaccine and most of the vaccine came pouring down her arm. Treatment information was not provided Action taken with mRNA-1273 in response to the events were not reported. The outcome of the event, a patient had the vaccine running down her arm after administration was considered as resolved on 11-Feb-2021.; Reporter's Comments: This report refers to a case of underdose and exposure via skin contact with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Exposure via skin contact', 'Underdose']",1,MODERNA,OT 1048969,NY,,M,"I'm on a blood thinner; A spontaneous report was received from an eighty two-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and during vaccination he forgot to disclose that he was on blood thinner Eliquis. The patient's medical history was not provided. The patient received their first of two planned doses of mRNA-1273 (BATCH # 031M20A) on 10 Feb 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient stated I got my first dose of the Moderna vaccine today (10 Feb 2021). I forgot to tell them I'm on blood thinner. No further information was reported. Treatment, action taken with RNA-1273 in response to the event and the outcome of the event were was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,UNK,ELIQUIS,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product monitoring error'],1,MODERNA,OT 1048970,CA,,U,"the injection was administered subcutaneously instead of intramuscularly; A spontaneous report was received from a health care professional, concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and nurse is concerned that the injection was administered subcutaneously instead of intramuscularly. The patient's medical history was not provided. No relevant concomitant medications were reported. On 10 Feb 2021, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On an unknown date, it was reported that the injection was administered subcutaneously instead of intramuscularly. The reporter wanted to know if administered subcutaneously, should a third dose be given due to insufficient protection. Action taken with study drug was not applicable as the subject had already received both scheduled doses The outcome of the event, nurse is concerned that the injection was administered subcutaneously instead of intramuscularly was resolved.; Reporter's Comments: This is a case of incorrect route of administration of the second dose of two planned doses of mRNA-1273 (lot # unknown) with no reported adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Incorrect route of product administration'],2,MODERNA,OT 1048971,TX,17.0,M,"First moderna shot on 1/12 and due for his second shot, turned away due to being 17 years; A spontaneous report was received from a consumer (patient's mother), regarding a 17 years-old male patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), which resulted in, first Moderna shot on 1/12 and due for his second shot, turned away due to being 17 years (product administered to patient of inappropriate age). The patient's medical history was not reported. No concomitant medications were reported. On 12 JAN 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection. The consumer reported that the patient was given his first Moderna shot on 12 JAN 2021. On 10 FEB 2021, the patient was due for his second shot and turned away due to patient being 17 years. The consumer contacted their primary care physician and trying to find out a way to get the patient his second shot, so the first one does not go waste. The consumer would like to enroll the patient in the trial for the second shot. No treatment medication information was provided. Action taken with second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, first Moderna shot on 1/12 and due for his second shot, turned away due to being 17 years, was recovered on 12 JAN 2021.; Reporter's Comments: This case concerns a 17 year old male who received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1048972,AZ,17.0,M,"<18 years old received the 1st dose of the moderna covid-19 vaccine; A spontaneous report was received from a healthcare professional concerning a 17-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No concomitant medications were reported. On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-20A) intramuscularly for prophylaxis of COVID-19 infection. On 12 Jan 2021, the reporter stated that after a vaccination drive thru they had a surplus vaccine of the vaccination site so they called in people to vaccinate. A family (mother, father and son) were vaccinated but the son was below 18 years of age and this wasn't confirmed before vaccination so he received the 1st dose of the Moderna covid-19 vaccine on 09 Jan 2021. No adverse events reported and no treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The event, <18 years old received the 1st dose of the moderna covid-19 vaccine, was considered resolved on 09 Jan 2021.; Reporter's Comments: This case concerns a 17 year old male who received fist dose of mRNA-1273 (Lot number: 025J20-20A) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1048973,NJ,,U,"immunizer by mistake instead of giving 1 shot of Moderna ended up giving 2 shots to the patient; A spontaneous report was received from a pharmacist concerning an unknown patient, of unknown age, who was administered Moderna's COVID-19 vaccine and reported that the immunizer by mistake instead of giving one shot of Moderna ended up giving two shot to the patient/extra dose administered. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection. The reporter mentioned the immunizer by mistake instead of giving one shot of Moderna ended up giving two shot to the patient on an unknown date. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not applicable. The outcome of event, the immunizer by mistake instead of giving one shot of Moderna ended up giving two shot to the patient was considered as resolved.; Reporter's Comments: This report refers to a case of extra dose administered for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Extra dose administered'],2,MODERNA,OT 1048974,CA,,F,"administered vaccine to pediatric patient (under 18); A spontaneous report was received from a nurse, concerning a 17 year old female patient who was administered Moderna's COVID-19 vaccine and was to receive second dose of Moderna Covid vaccine (product administered to patient of inappropriate age). The patient's medical history was not provided. No relevant concomitant medications were reported. On 19-JAN-2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection. The patient went to the administering site to receive second dose of Moderna Covid vaccine. She was a pediatric patient. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event, administered vaccine to pediatric patient (under 18) was considered as resolved on 19-JAN-2021.; Reporter's Comments: This case concerns a 17 year old female who received fist dose of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1048975,GA,19.0,M,"pharmacist administered second vaccine on day 18; A spontaneous report was received from a pharmacist, concerning a 19-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the pharmacist administered second vaccine on day 18 (PT: Inappropriate schedule of product administration). The patient's medical history was not provided. Concomitant medications included erythromycin, promethazine, dextromethorphan. On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030L20A) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection. On 15 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 031L20A) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, pharmacist reported that the patient received second dose of vaccination on day 18, after his first dose. Action taken with mRNA-1273 was not applicable. The outcome of the event pharmacist administered second vaccine on day 18 was resolved on 15 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273 (lot number 031l20A) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,02/15/2021,18.0,UNK,ERYTHROMYCIN; PROMETHAZINE; DEXTROMETHORPHAN,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Inappropriate schedule of product administration'],2,MODERNA, 1048978,IL,38.0,F,"I had headache and nausea for the rest of the day that I got the vaccine. After that I was fine. As a result I didn't feel like doing anything but laying down. Also as expected, I had pain at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/13/2021,0.0,PHM,"zyrtec, flonase, restasis, levothyroxine",not sure it counts as an illnesses but buildup of sinus mucus (why using zyrtec / flonase to avoid sinus infections),none,,"sulfa, augmentin","['Headache', 'Injection site pain', 'Nausea']",UNK,PFIZER\BIONTECH, 1048979,NY,49.0,M,"Shingles rash started on 2/16/2021. T7, T8 right side from midline back to midline anterior torso. Treated with Valtrex 1 grm TID",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/20/2021,02/16/2021,27.0,PVT,,,,,,"['Herpes zoster', 'Rash']",UNK,PFIZER\BIONTECH, 1048980,WV,44.0,F,"Patient received 2nd Moderna dose during vaccination clinic, which is her employer. She previously received her 1st Moderna dose, with no adverse reactions reported to Pharmacy, on 1/15/2021. On Monday, 2/22/21, patient reported to her school nurse, located at SSchool, that she developed a ""tingling sensation from the bend of the arm down to the top of the hand."" She reports this began on 2/12/21, the day she received the vaccine, and states it ""has not gotten better nor worse"" since. The school nurse, may be reached at mobile phone number. Both nurse and Executive Secretary to the Superintendent Schools, advised patient to see her primary care provider as soon as possible.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,PHM,None reported,None reported,None reported,,None reported,"['No reaction on previous exposure to drug', 'Paraesthesia']",2,MODERNA,IM 1048981,NC,65.0,M,"Covid Arm . 8-10 inch light red, itchy rash extending equally up and down arm from injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/18/2021,6.0,PUB,None,None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash']",UNK,MODERNA,IM 1048982,MI,79.0,F,nausea/vomiting; tiredness,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/13/2021,1.0,PHM,amoxicillen; carvedilol; pravastatin; isosorbide; benazepril; metformin; lotensin; lasix; zoloft; mucinex; vitamin D/C; norco; albuterol,ear infection; throat and sinus infection,"heart, diabetes, back pain, neck pain,",,aleve; Definity; morphine; neurontin; codeine,"['Fatigue', 'Nausea', 'Vomiting']",1,MODERNA,SYR 1048984,FL,72.0,M,"2-17-21 mid after noon started experiencing fever, cold sweats, fatigue. Took advil and states it helped. reports light headedness, advised that is not common and should get seen at an urgent care to r/o other potential causes.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/17/2021,0.0,OTH,lisinopril- hctz 2-25mg Daily,,HTN,,none,"['Cold sweat', 'Dizziness', 'Fatigue', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1048985,PA,76.0,F,"Patient received 2 doses of COVID-19 vaccination in same arm on same day (several minutes apart). No symptoms reported, aside from anxiety-induced blood pressure elevation",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PUB,"aspirin 81mg, atorvastatin 40mg, escitalopram 10mg , cholecalciferol 1000mcg, hydrocortisone supp 25mg daily, insulin degludec-liraglutide, isosorbide mononitrate 30mg, metformin XR 500mg daily, metoprolol succinate 37.5mg daily, pantoprazo",,"hyperlipidemia, IBS, osteoarthritis, type 2 diabetes",,"amoxicillin, ranitidine, sulfa","['Anxiety', 'Blood pressure increased']",1,PFIZER\BIONTECH,IM 1048986,NY,73.0,F,Symptoms occurred about a week after the first AND the second covid vaccination. Lot number of first is EI9262 and of second (as above) EN6201. In addition to expected fatigue and chills (I experienced no sore arm or fever) I developed symptoms of gallbladder attack with extreme abdominal pain and vomiting. These lasted for just over 2 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/20/2021,4.0,OTH,,,,,,"['Biliary colic', 'Chills', 'Fatigue', 'Vomiting']",UNK,PFIZER\BIONTECH,SYR 1048987,NY,75.0,F,"Pt states the night after receiving the covid vax she had redness, pain and swelling at the injection site. Pt stated that about 8 days later that she developed a rash surrounding the injection site and still has it. Pt contacted her PCP and they told her she may have an allergic reaction to the covid vax but did not suggest taking any medication.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/08/2021,0.0,PHM,"pantoprazole 40mg, chlorthalidone 12.5 mg,",no,"HBP, chlorestoral",flu shot - pt sometimes has swelling and redness at injection site after taking this vax,Levaquin,"['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Skin reaction']",1,MODERNA,IM 1048988,FL,69.0,F,"sore arm - started about 24 hrs later and lasted about 2 days severe headache - started about 24 hrs later and persists still chills and sweating - started about 36 hours later and persists still stomach ache and diarrhea - started the 15th, worsened over days and still persists fever - although I felt like I had a fever i did not record a fever until the 21st-22nd--it was 100.2",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,UNK,daily vitamin vitamin D Magnesium supplement as[itin or aleve as needed,Chiari Malformation and related neurological issues Joint pain/srthritis,Chiari Malformation and related neurological issues,,none,"['Abdominal pain upper', 'Chills', 'Diarrhoea', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1048989,OH,78.0,F,Waited 15 minutes after receiving the vaccine; went to car and when driving home about 30 minutes later my face and lips on the left side of my face went numb. The vaccine was placed in my left arm. The numbness lasted about 2 hours and then went away.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PVT,None,None,Good,,None,"['Hypoaesthesia', 'Hypoaesthesia oral']",UNK,PFIZER\BIONTECH, 1048990,IL,27.0,F,"Headaches, fever, feeling foggy",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/01/2021,,UNK,None,None,None,,None,"['Feeling abnormal', 'Headache', 'Pyrexia']",UNK,MODERNA, 1048991,NJ,73.0,F,"About 20 minutes after receiving the vaccine, the patient complained of congestion in her throat and numbness of tongue and right side of face. Patient was given 50 mg of Benadryl. Numbness spread to arms. After about 15 minutes, patient complained of feeling dizzy. Patient was observed for about 20 minutes more. Symptoms did not progress. Patient was advised to follow up with PCP. Spoke with the patient on 2/19/2021. Patient stated that she was feeling much better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,OTH,,,Migraines,,Patient carries an Epipen,"['Dizziness', 'Hypoaesthesia', 'Hypoaesthesia oral']",1,MODERNA,IM 1048992,MA,21.0,F,"Moderna COVID?19 Vaccine EUA Dizziness, Vomiting, Diarrhea, Muscle Aches, Fever, Headache ALL symptoms last 2 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,OTH,None,Migraines,None,,None,"['Diarrhoea', 'Dizziness', 'Headache', 'Myalgia', 'Pyrexia', 'Vomiting']",2,MODERNA,SYR 1048993,TN,37.0,F,bruise at injection site swollen lymph node under left arm in armpit - appeared around day 4,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/19/2021,3.0,PUB,Progesterone/testosterone Vit D Magnesium Zinc MultiVitamin Iron,Sinus infection in January,,swollen lymph node after flu vaccine,Sulfa-based drugs,"['Injection site bruising', 'Lymphadenitis']",1,MODERNA,SYR 1048994,MO,54.0,M,Pain at the injection site and swelling at axilla that is not resolving,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,PUB,,,sleep apena,,,"['Injection site pain', 'Oedema peripheral']",2,PFIZER\BIONTECH,IM 1048995,GA,70.0,M,Bleeding stomach ulcer,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/03/2021,1.0,PUB,Citalopram 30 mg daily Loratadine 10 mg Pseudoephedrine 240 mg,,,,Naproxin,"['Gastric ulcer', 'Haemorrhage']",UNK,MODERNA,IM 1048996,CA,77.0,F,Very sore arms and fever of 100.1,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,PUB,"Metoprolol, spironolactone, acid controller, vitamin D",none,high blood pressure,,penicillin,"['Pain in extremity', 'Pyrexia']",2,MODERNA,SYR 1048997,IN,74.0,F,"5 hrs after injection started getting a headache,10 hrs after started getting constant aching injection site arm, from elbow to shoulder, swelling, no redness, no heat. Low grade temp. Took 2 Tylenol 650 mgs. Unable to sleep even with elevated arm and ice.. Continued through the next day but headache gone.Arm pain constant if left down.Next day swelling reduced, but still constant ache, muscle, bone and joints. Today improved, still aching, but tolerable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PUB,Atenolol 50 mgs 1 q AM...Meloxicam 15 mgs 1 q AM...Enelapril 10 mgs 1 q AM... Omeprazole 40 mgs 1 q AM...HCT 25 mgs 1 q AM...Montelukast 10 mgs 1 HS,None,O/A,,NKA,"['Arthralgia', 'Headache', 'Injection site pain', 'Injection site swelling', 'Insomnia', 'Pain']",2,MODERNA,IM 1048998,,78.0,F,"Covid Arm and three days later a hives/welt rash that I have had for 4 weeks. Getting better, but still flare ups.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/22/2021,01/31/2021,9.0,OTH,,,,,"Erythromycin, Codeine, antihistamines","['Rash', 'Skin reaction', 'Urticaria']",1,MODERNA,IM 1048999,GA,70.0,F,"Moderna COVID-19 Vaccine EUA First symptoms appeared about 8PM the evening of the shot - a feeling of being weighted down, with extra difficulty in moving about. I went to bed early and when I woke up I had a fever of 101.5 accompanied by chills, body aches, nausea, fatigue, brain fog, and headache. Over the course of two days, my temperature ranged from 101.5 to 103. After two days my fever broke during the night. I did not want to take fever reducing medication in case it interfered with the immune response, but I did take 1 dose each of Tylenol and Motrin over the course of the 2 days. Still felt a bit sluggish on the 3rd day and continue to have brain fog 6 days later.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,PHM,none,none,none,I felt very flu-like for 2 days after the 2nd dose of the Shingrix vaccine. I received it about 3-4 years ago.,"Ceftin, Avelox","['Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Pain', 'Pyrexia', 'Sluggishness']",2,MODERNA,IM 1049000,MN,49.0,F,"When I first got the shot, my right hand tingled for a few minutes and then it went away. My arm hurt for About a week after the vaccination my right arm (where I got the vaccination) started to itch. I felt a slight bump- like a mosquito bite- where the shot happened. The next day I had a slight rash. Since then, there is a larger circle around the injection site and it has itched since then. The rash is still there and it itches off and on- especially when my sleeves rub the wrong way on it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/17/2021,7.0,OTH,"Birth control, prilosec",None,Acid Reflux,,None,"['Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Paraesthesia']",1,MODERNA,SYR 1049001,,46.0,F,"Pain in arm, upper body aches, back, neck, shoulder, headache sore throat, congestion.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/20/2021,1.0,UNK,,,,,,"['Headache', 'Nasal congestion', 'Oropharyngeal pain', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,SYR 1049002,WV,52.0,F,"exhaustion, fever of 102, bone pain, chills, muscle/joint aches, headache, sweating, lump (size of small apple) in my left armpit. All symptoms subsided by Wednesday except exhaustion and lump.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,PVT,"mobic, carvedilol, metformin, Arava",,"autoimmune Hashimoto's, autoimmune issues, pre-diabetic",,morphine,"['Arthralgia', 'Axillary mass', 'Bone pain', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1049003,IA,71.0,F,"Dizzy, shortness of breath, oral swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PVT,,,COPD,,None,"['Dizziness', 'Dyspnoea', 'Mouth swelling']",1,PFIZER\BIONTECH,IM 1049004,ND,34.0,F,"Extreme fatigue, burning muscles, bruising, night sweats, borderline low platelets, high MPV, dizziness, cannot exercise",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/19/2021,15.0,PVT,None,None,None,,Eggs,"['Contusion', 'Dizziness', 'Exercise tolerance decreased', 'Fatigue', 'Mean platelet volume increased', 'Myalgia', 'Night sweats', 'Platelet disorder']",2,PFIZER\BIONTECH,IM 1049005,LA,65.0,M,On Sunday morning he noticed abdominal pain and he's been noticing that off and on since Sunday.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,PHM,vitamin d3 baby aspirin blood pressure medicines hydrolozine insulin,No,diabetic hypetension,,No,['Abdominal pain'],1,MODERNA,SYR 1049006,KY,57.0,F,"COVID Arm. Red rash and itching appeared post vaccination on day 8 to 9. Slight red circular area app. 2"" in diameter, warm to the touch and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/21/2021,9.0,PHM,"L-Thyroxine 50msg, Pantoprazole 40mg, Ocuvite Gummies, Enegen-c with vitamin D Gummies, Adult calcium gummies with D3 500Mg","Hypo Thyroidism, Gerd",Leaky Heart Valve,,Penicillin,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",UNK,MODERNA,UN 1049007,FL,38.0,F,"Sore arm, swollen eye (lump under the skin and visible in the rim of the eye, fatigue, malaise, headaches, chills, diarrhea. All recovered other than the sore eye.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,UNK,None,None,None,,None,"['Chills', 'Diarrhoea', 'Eye pain', 'Eye swelling', 'Fatigue', 'Headache', 'Malaise', 'Pain in extremity']",2,PFIZER\BIONTECH, 1049008,FL,81.0,M,"02/18/21, pain started later that day",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,PHM,Pantoprazole Eliquis Pravastatin Isosorbide mono Losartan Metoprolol Dutasteride Aspirin Vitamin D3 NTG PRN,,"cardiac stents Heart attack in 2007 High BP under control Sharp pain around the left kidney in the back when moving, when sitting still feels no pain. PT has not had any trouble urinating.",,"Dust, yeast, penicillin and codeine(tremors)",['Pain'],1,MODERNA,IM 1049009,IN,68.0,F,Discomfort at injection site almost immediately & then a real weird nausea at 36 hrs that lasted 12 hrs - tired,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/20/2021,2.0,PUB,,,Hypertension,,"Tetracycline, Thimerosol","['Fatigue', 'Injection site discomfort', 'Nausea']",2,MODERNA,IM 1049010,NY,73.0,M,"SEVERE INFLAMMATORY FLARE-UP at site of osteoarthritis, both knees (first time in 14 years, left knee; first time in 7 years, right knee) Right knee approximately 80% recovered, left knee approximately 60% recovered and improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/20/2021,4.0,OTH,irbesartan 300 hydrochlorothiazide 50 amlodipine 2.5 simvastatin 10,,osteoarthritis knees hypertension,,none,"['Arthritis', 'Joint swelling']",UNK,MODERNA,IM 1049012,AZ,72.0,F,"Patient was given vaccine on friday, one week later she passed away. The family called the pharmacy to inform us on Saturday, Feb 20, 2021. After the phone call was over, we saw in her pharmacy profile that she had received the vaccine one week prior",Yes,02/19/2021,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,PHM,"lisinopril, lovastatin, diclofenac sodium, nifedipine ER, Anastrozole, Alendronate",,,,NKDA,['Death'],1,MODERNA,IM 1049013,NC,67.0,F,I got very tired and I felt achy. I started feeling a tingle and numbness in my hands and fingers. I had pain around the base of my thumb on my left hand.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,PVT,Metformin Atorvastatin Losartan Glipizide ER Baby Aspirin Caltrate Alendronate (only takes once a week),No,Diabetes High Cholesterol,,No,"['Fatigue', 'Hypoaesthesia', 'Pain', 'Pain in extremity', 'Paraesthesia']",1,PFIZER\BIONTECH,SYR 1049014,GA,33.0,F,"Severe aches, pains, headache, chills, nausea and vomiting that lasted for 2 full days following vaccination. Unable to keep anything down from 0100 on 2/19 to 2/21 0900. This was following the first shot and now I am terrified to get second vaccine as many folks say second vaccine symptoms are worse.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,UNK,None,None. Tested positive for Covid 19 on 12/28/2020,None,,None,"['Chills', 'Headache', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,IM 1049015,IA,17.0,M,Patient underage for vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PVT,,,,,,['Product administered to patient of inappropriate age'],2,MODERNA,IM 1049017,CO,36.0,F,Extreme brain fog and fatigue. Burst of energy and then need to sleep for hours. Missing work due to effects.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/22/2021,3.0,SCH,Sertraline,,,,"Sulfa, latex","['Energy increased', 'Fatigue', 'Impaired work ability', 'Mental impairment', 'Somnolence']",2,PFIZER\BIONTECH,SYR 1049018,NY,91.0,M,on the 18th he started to hallucinate and has continued for the last 4 days. seeing people sitting on the couch and all over the house,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/18/2021,7.0,MIL,"metoprolol, losartan 25 mg, Aspirin 81 mg, multivitamin, vitamin D3 25 mcmg, melatonin 3 mg, Cetirizine, fish oil 1200 mg, Simvastatin 40 mg, asediphyliis,",,"Dementia,",,,['Hallucination'],2,MODERNA,IM 1049019,NY,59.0,F,"1. Throat closed up, could not breathe 2. Coughing 3. Nausea Treated with: EpiPen x2 Oxygen Nebulizer Treatment",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/28/2021,01/28/2021,0.0,SEN,,,,,,"['Cough', 'Dyspnoea', 'Epinephrine', 'Nausea', 'Throat tightness']",2,PFIZER\BIONTECH,IM 1049020,MD,75.0,F,"four days after the shot I began to feel fatique and dizzy headache , cold ,vomited and sudden sweats. I spent 4 days in bed tired and feeling as if I had flu. nauseous if I got out of bed. I do not believe Ii had a fever but threw up once a day during the four days in bed. I continued to feel under the weather for some days after I got out of bed. eventually I took advile . I do not believe I took anything when I was actively vomiting. My question ; IS IT SAFE FOR ME TO TAKE SECOND VACCINE ON THURSDAY 02 25 21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,OTH,VITIAMS C AND D TURERIC aller-tec hydrochlorothiazide,ALLERGY,high blood presure,,SEASONAL ALGERIES,"['Dizziness', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Influenza like illness', 'Nasopharyngitis', 'Vomiting']",1,MODERNA,IM 1049021,MI,71.0,F,"arm swollen, red, itchy, . Spreading around to underside of arm. Face "" feels funny"" though no visible swelling or redness noted",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/20/2021,2.0,PVT,"Losartan 50mg, Vit D, Zinc 50 mg, Ubicquinol, Multi vit, Omega fatty acids Tramadol prn Tylenol prn",none,Chronic Lymphocytic Leukemia,,"C-chlor, pennicillins, E mycin, Bees, Adverse reaction to Cipro= severe tendonitis","['Erythema', 'Peripheral swelling', 'Pruritus']",UNK,PFIZER\BIONTECH,IM 1049022,NY,55.0,F,Patient felt dizzy post covid vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,,,,,,['Dizziness'],2,MODERNA,IM 1049023,WV,41.0,F,"Patient received her 2nd Moderna dose on 2/12/21 at a vaccination clinic at School, her employer. She previously received her 1st Moderna dose on 1/15/21 at another School clinic. On Tuesday, 2/16/21, patient reported to her school nurse, at School, that she ""developed hives around the upper arm and a burning sensation in the palm"" following receiving the 2nd Moderna dose. Patient was advised by Nurse, and Executive Secretary to the Superintendent of Schools, to contact her primary care provider as soon as possible.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/12/2021,0.0,PHM,None reported,None reported,None reported,,None reported,"['Burning sensation', 'Urticaria']",2,MODERNA,IM 1049024,KY,30.0,F,"7W & 4D pregnant at the time of this vaccination, No complications with pregnancy. Fever, chills, body aches, migraine, nausea, vomiting, hot & cold flashes for 2 days. Symptoms started 12 hrs after vaccine received.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,PVT,"tylenol, pre natal vitamin",none,none,,none,"['Chills', 'Foetal exposure during pregnancy', 'Hot flush', 'Migraine', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,MODERNA,IM 1049025,MN,67.0,M,"fever, chills and headache",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,PVT,"vitamin D, Flaxseed, folic acid, probiotic, lisinopril, melatonin, metformin, milk thistle",none,HTN DM COPD Seasonal depression Umbilical hernia,,"PCN, bactrim","['Chills', 'Headache', 'Pyrexia']",2,MODERNA,IM 1049026,MI,84.0,F,chills and very achy for about 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/28/2021,2.0,SEN,"Trajenta, Lipitor, Glimipride, lyrica, Neurontin, Lasix, breo, proair, Prilosec, Vitamin D, metoprolol, synthroid, percocet",none noted,"COPD, CHF, arthritis, GERD, diabetes, HTN, CKD",,"Baclofen, Canagliflozin","['Chills', 'Pain']",2,MODERNA,IM 1049027,OH,65.0,M,"Intermittent soreness in area of the vaccination, Moved arm in circular motions for relief. Soreness completely gone after 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/13/2021,0.0,PVT,"Spironolactone, Chlorthalidone, Losartan, Allopurinol, Pravastatin, Fish Oil, Vitamin C, Low Dose Aspirin",None,None,,None,['Injection site pain'],1,PFIZER\BIONTECH,SYR 1049028,OH,69.0,F,"On February 18, about 6:00 pm, I felt so cold, shivering uncontrollably. Bundled up in robe, and 2 afghans. Low grade fever of 99.6. Went to bed. Fever must have been high during night according to husband. Slept through it. Following morning, felt washed out, ache around my eyes. By 6:00 pm, no symptoms at all.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,OTH,"SIMVASTATIN, ANASTROZOLE,HYDROCHLOROT,LOSARTAN, VITARMIN D2, L",NONE,"BREAST CANCER , NOV 2018, SURGERY AND TREATMENT, NO CANCER FOUND SINCE",,NONE,"['Chills', 'Eye pain', 'Nasopharyngitis', 'Pyrexia']",UNK,MODERNA,SYR 1049029,FL,50.0,F,"In addition to expected side effects of fever, chills, headache, body aches, pain and warmth at the injection site, and diarrhea and nausea, employee also had joint pain in shoulder and neck on left side, pain in elbow and wrist and itching and burning in feet. Pain in lower lumbar region of back, SOB.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,PVT,"Visoprolol, Protonix, Benedryl",None,"Tachycardia, GERD, overweight, asthma, seasonal allergies, mold allergies",,"Sulfa, shellfish, dye in CT scan","['Arthralgia', 'Back pain', 'Burning sensation', 'Chills', 'Diarrhoea', 'Dyspnoea', 'Headache', 'Injection site pain', 'Injection site warmth', 'Nausea', 'Pain', 'Pruritus', 'Pyrexia']",2,MODERNA,IM 1049030,NC,21.0,F,Patient arrived for 2nd dose of COVID-19 vaccine. She was given Pfizer but was supposed to receive Moderna for her 2nd dose.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PUB,,,"Tachycardia, Asthma, Endometriosis",,Doxycycline,['Interchange of vaccine products'],2,PFIZER\BIONTECH,IM 1049031,TX,77.0,M,developed Bell's Palsy 10 days after second shot,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,02/11/2021,37.0,UNK,,,,,,"['Emergency care', 'Facial paralysis']",UNK,MODERNA,IM 1049032,SC,47.0,F,"fever, chills, muscle ache, fatigue, headache that lasted 12 hours. Negative covid test.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/28/2021,17.0,PVT,"zyrtec, ibuprofen",None,,,"toradol, betadine","['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 1049034,GA,71.0,F,"On 2/18/21, her arm felt itchy, got up and went and looked in the mirror and her arm was red and swollen. She rubbed the area and the reaction was below the injection site (1/4"" below). It runs down the arm 3"" from the injection toward her elbow, and width is 5"". It is not as puffy as it was, somewhat paler, but very obvious and noticeable. It is not itching as bad, and is putting wet washcloths on it for relief. The size of it is still the same size and has not changed, possibly spread a little. She called her doctor who told her to take Tylenol and put the cool rags on it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/18/2021,7.0,OTH,"Baby aspirin, Alprazolam.","Had CAT scan on 1/27/21 with contrast, and had saline.","Intestinal issues, cyst on pancreas.","Flu shot about 36 years ago where she ran fever, stayed in the bed for 7 days, no appetite. Has not had any other vaccine since","Onions (extreme rash, swelling). Codeine (vomiting), Prednisone.","['Injection site erythema', 'Injection site pallor', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 1049035,OH,81.0,F,"On Sunday, February 21 at 07:42 AM I received a call from patient advising me she had called for an ambulance, she was awoken from her sleep with a rapid heart beat and was also suffering from shortness of breath. Patient was taken to Hospital where she was admitted due to a Pulmonary Embolism, a small clot was found in her lung.",Not Reported,,Yes,Yes,3.0,Not Reported,N,02/13/2021,02/21/2021,8.0,PVT,Unknown - will need to follow up with Hospital,,,,Penicillin Codeine,"['Blood test abnormal', 'Chest X-ray', 'Computerised tomogram', 'Computerised tomogram thorax abnormal', 'Dyspnoea', 'Electrocardiogram', 'Heart rate increased', 'Pulmonary embolism', 'Thrombosis', 'Ultrasound Doppler']",2,PFIZER\BIONTECH,SYR 1049036,OH,61.0,F,Swollen Lymph Nodes under left arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/22/2021,2.0,UNK,,,,,Wheat,['Lymphadenopathy'],2,PFIZER\BIONTECH,SYR 1049037,NC,74.0,F,"At site of shot on night of Feb 16, my arm was itchy and hurting. By the morning of Feb 17, My arm was swollen at the site shot, red, hard and painful. I was alarmed as this was a full week after the vaccine and my arm had not bothered me for the first week. I reported to Health Dept & received a call from a volunteer doctor who told me I had Covid Arm and to use cold pack, tylenol to relieve symptoms and benydryl at night to help me sleep. I am due to get shot #2 on March 9 and am concerned. My Covid Arm lasted 5 days and went away.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/16/2021,7.0,PUB,"Diltiazem (BP med), preservision (2 tab / day), lavalo (statin), co-q-10 (100 mg), potassium & magnesium supplements, calcium and vitamin D supplement, centrum silver multivitamin, natural psyllium fiber (Konsyl 1 Tbsp 3 times /week)","Two weeks prior to first shot I had headache, fatigue, and aches ? no fever",Asthma,,"All classes of Ampicillan drugs (Penicillin) , All sulpha drugs Extremely allergic to mold, and particulates (wood smoke or cigarette smoke), cat & dog dander","['Injection site erythema', 'Injection site nodule', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA,SYR 1049038,TN,44.0,F,"Extremely dry throat, tongue felt swollen towards the back, BP 133/90, itchy hands (this was within 10-12 minutes of vaccination- called primary care physician, she recommended monitoring- Nurse gave me small dose of Benedryl which helped the symptoms- that night I ran fever, itchy feet and palms again and small bumps on my chest- day2 of vaccine- muscle aches, fever, overall flu-like feel, rash on chest still present, but not itchy- day 3- much better, low grade fever, no allergy reactions noted.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,SCH,NONE,NONE I did have COVID-19 diagnosis in last week of November,,,,"['Dry throat', 'Influenza like illness', 'Myalgia', 'Pruritus', 'Pyrexia', 'Rash', 'Swollen tongue']",1,MODERNA,SYR 1049039,,81.0,F,"Vaccine reaction, initial encounter, pain left deltoid, no erythema, vaccine given 4 days ago, suspect she is having localized pain from injection, fairly thin arms, making it more pronounced, treat supportively, stable condition at time of discharge, pain described as achy, hurts when moves her arm, pt. having some memory issues and relies on husband most of the time, arthralgias and myalgia, [t discharged home, tylenol prn, follow up with Dr if not improving over next 2 weeks.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/18/2021,1.0,OTH,,,,,,"['Arthralgia', 'Injection site pain', 'Memory impairment', 'Myalgia', 'Pain', 'Vaccination complication']",1,PFIZER\BIONTECH,IM 1049040,FL,74.0,M,"low grade temp 10 days ago.....in the afternoon his temp is 99.5, in the am its low or normal",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,,,PUB,,,,,,['Pyrexia'],UNK,PFIZER\BIONTECH,IM 1049041,PA,69.0,M,"patient states that immediately following administration of covid vaccine on 2/5 he began to experience profuse sweating, dizziness and nausea. He went home and then went to the ED for syncope on 2/6. Prior to ED, patient states that he became so dizzy that he lost control of his head and it slammed on the table he was sitting at leading him to go to the ED. The ED note is without mention of the vaccine. However, when pt saw me on 2/9, he states that all of his symptoms were r/t the vaccine. He left ama from the ED who wanted to admit him for a cardiac eval. I did not witness administration nor did I know patient prior to visit. I just saw him following his ED visit. It is not my intent to mislead the Department of Human and Health Services, I am simply reporting what the patient told me.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/05/2021,0.0,PVT,"acetaminophen, ambien, fluticasone, levitra, meloxicam, omeprazole, ropinirole",,"mild depression, overweight, copd, gerd, fatty liver, djd",,"calcium, vitamin d","['COVID-19 immunisation', 'Dizziness', 'Head injury', 'Hyperhidrosis', 'Immediate post-injection reaction', 'Nausea', 'Refusal of treatment by patient', 'Syncope']",UNK,MODERNA, 1049042,CA,30.0,F,"Fever, headache, nausea, muscle pain, back pain, fatigue, 'brain fog'",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,PVT,Contraceptive pill,None,None,,None,"['Fatigue', 'Feeling abnormal', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",2,MODERNA,SYR 1049043,MN,76.0,F,Fever 100 Achy joints Chills,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PVT,"Synthroid, cyclobenziprene, metropolol, rosuvistatin, vitamin D",X,Osteoarthritis,,X,"['Arthralgia', 'Chills', 'Pyrexia']",2,PFIZER\BIONTECH, 1049044,TX,52.0,F,"Hives on neck, chest/breast area and abdomen.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/22/2021,2.0,PUB,Lisinipril 10 mg,None,High Blood Pressure,,"Certain antibiotics- Cipro, amoxicillin Cyclobenzoprine- muscle relaxer Immune boosting meds-Ziacam, EnergenC, Airborn",['Urticaria'],UNK,MODERNA, 1049045,NY,46.0,F,"I got the vaccine on the 8th and then about at 8 at night on the tenth, and my throat started to close, and I couldn't breathe. I was sent to the hospital where I was intubated. I went into anaphylactic shock and cardiac arrest and then respitory failure.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/08/2021,02/10/2021,2.0,SCH,symbocort 80/4.5 mg 2 puffs in the AM and 2 in the PM vitamin C 500 mg zinc spray edleberry (immune booster),No,Asthma,,nut allergy (lips and tongue swell up),"['Anaphylactic shock', 'Cardiac arrest', 'Chest X-ray', 'Computerised tomogram', 'Dyspnoea', 'Endotracheal intubation', 'Full blood count', 'Pharyngeal swelling', 'Respiratory arrest', 'Respiratory failure', 'Throat tightness', 'Urine analysis', 'X-ray']",1,MODERNA,SYR 1049046,WI,80.0,F,Broke out with hives on both arms and upper legs.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/21/2021,4.0,PVT,Levothyroxin: diclofenac sodium 50 mg:multiple vitamins: fish oil: vitamin C:calcium 500: vitamin D3: every 2 months remicaid,None,PMR / renaudes,,None that I know nonenone,['Urticaria'],2,PFIZER\BIONTECH,IM 1049047,IA,35.0,F,"Headache and dizziness started at 10:30pm on 2/15/21. I began to feel nauseated around 11:15pm. Body aches, chills and fever started around 11:45. My fever peaked at 101.2 at 2am. Pain relievers and fever reducers did not help. I had cold sweats throughout the night, not able to sleep consistently through the night due to body aches, headache and nausea. Left arm became swollen, hot and hard to the touch, this lasted through 2/17/21. The arm was itchy from 2/18-2/20/21. The fever and body aches lasted through 2/16 until about 10:15pm, around 11:00pm the headache went away. I was feeling mostly recovered with the exception of the arm by the morning of 2/17.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,PHM,"Losartan, Cimetidine, Escitalopram, Metformin, Mirena",None,"Diabetes, hypertension",,"Morphine, Latex, Adhesives, Lactose intolerance","['Chills', 'Cold sweat', 'Dizziness', 'Feeling hot', 'Headache', 'Nausea', 'Pain', 'Peripheral swelling', 'Pruritus', 'Pyrexia', 'Sleep disorder']",2,MODERNA,IM 1049048,MI,75.0,F,"Approximately 32 hours of extreme fatigue, low grade fever, chills and she lost function in her hands which occurs when she gets sick due to her multiple sclerosis",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/28/2021,2.0,SEN,"synthroid, baclofen, lyrica, calcium, multivitamin, vitamin C, magnesium, acidophilus, potassium, miralax, azelastine, Flonase, Prilosec, melotonin, Lipitor, Senna, B12, Lasix, Cymbalta, bacrim, trazadone",none noted,"multiple sclerosis, neuropathy, GERD, hypothyroidism, depression, anxiety, hypokalemia, insomnia, hyperlipidemia, hypertension",,NKMA,"['Chills', 'Fatigue', 'Multiple sclerosis', 'Musculoskeletal disorder', 'Pyrexia']",2,MODERNA,IM 1049049,NY,65.0,F,"I was vaccinated nine days ago. I have consistently been having chills, a dull headache and fatigue. I was really sick by the end of the day after the vaccine. The fatigue, initially, put me in bed for a few days. It is not as severe now. It is mild to moderate. I feel week sometimes. It comes and goes.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/15/2021,1.0,OTH,"Amlodipine Besylate, Rosuvastatin Calcium, Atenolol, Spironolactone, Famotidine, Synthroid, Metformin, Hydrochlorothiazide, Allegra (over the counter 180 mg)",none,"controlled high blood pressure, borderline diabetes, obesity",,"Thimerosal, p-Phenylenediamine, bee stings, dust mites, seasonal allergies","['Chills', 'Fatigue', 'Headache', 'Malaise']",1,PFIZER\BIONTECH,IM 1049050,MI,16.0,F,"Client present for second dose, and nurse discovered that she was only 16 years old. Client had received first does of Moderna 4 weeks prior, and therefore was due for her second Moderna- despite the fact that she was underage for that manufacturer. Moderna is currently approved for those 18 and up. Our Medical Director was contacted, and he informed us that we should continue with Moderna instead of switching to Pfizer for the second dose. While the client was underage for the Moderna vaccine- there is no research done to choose to switch manufacturers between dose one and dose two. Mom was informed of what happened, and stated she was OK with continuing with the Moderna shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,PUB,,,,,,['Product administered to patient of inappropriate age'],2,MODERNA,IM 1049051,IN,28.0,F,"Fever 101-102, body chills, body aches, generalized skin sensitivity, sore eyes, sore at injection site, headache, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PVT,Tylenol right after vaccination,none,none,,"Amoxicillin, Penicillin","['Chills', 'Eye pain', 'Fatigue', 'Headache', 'Hyperaesthesia', 'Injection site pain', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1049052,DE,62.0,F,"Fever (103+), vomiting, chills, headache, nausea, sweating, fatigue for 36+ hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,None,"Covid positive with low temp and headache and mild symptoms December 11-18, 2020.",None,,None,"['Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,SYR 1049053,NE,73.0,M,"Fatigue, loss of appetite, diarrhea, chills. Began 20 hours after first vaccination and lasted for 8 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,SCH,,None,Pulmonary hypertension,,None,"['Chills', 'Decreased appetite', 'Diarrhoea', 'Fatigue']",UNK,PFIZER\BIONTECH, 1049054,FL,73.0,F,A lump at injection site that is bruised. Not tender or painful.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/13/2021,0.0,OTH,Pravastatin Lisinopril Levothyroxine,,,,,"['Injection site bruising', 'Injection site nodule']",2,PFIZER\BIONTECH,IM 1049055,FL,65.0,F,"Itchy at injection site with red circular area about 3 inches in diameter. First noticed on 2/22/21, 9 days after receiving the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/22/2021,9.0,PHM,Olmesartan Medoxomil 20 mg/daily Ibandronate Sodium 150 mg/once a month low dose aspirin/daily,None,High Blood Pressure Osteopenia,,None known,"['Injection site erythema', 'Injection site pruritus']",UNK,MODERNA,SYR 1049056,CA,74.0,M,Extreme sensitivity / intolerance to loud sounds. During the cleaning of my house by people who have been doing it for years I found that the sounds of a vacuum cleaner working and normal conversations between the cleaners and my wife and daughter became almost intolerable. I was unable to concentrate on work I was doing and had to go to a room where those sounds were significantly less. I have never before experience this intolerance to customary sound levels. The intolerance passed within about three hours of when I noticed it.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/22/2021,2.0,OTH,,None,Pre-diabetes,,None,"['Disturbance in attention', 'Hyperacusis']",1,MODERNA,IM 1049057,NJ,53.0,F,"Severe Headache, Hives, Vomiting, Body Aches, Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,daily vitamin,none,none,,none known,"['Headache', 'Pain', 'Pyrexia', 'Urticaria', 'Vomiting']",2,MODERNA,IM 1049058,FL,78.0,F,erythema and itching at injection site; warm to touch,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,02/18/2021,8.0,OTH,"voltaren, omperazole, gabapentin, pravastatin, aricept",,"GERD, neuropathy, elevated cholesterol",,,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 1049059,,72.0,M,"Woke at 4:30am with a pounding headache, every muscle and bone in my body ached. I was freezing and couldn't get warm. Site of injection was very sore. I had no temperature. Got out of bed at 7:00 am and still had a pounding headache and couldn't get warm without a blanket. Throughout the day I felt better but still had the headache, (I rarely get headaches and if I do they don't last). Went to bed at 11 pm 02 /22/2021 with a headache. Woke 02/23/2021 with a slight headache. I didn't take aspirin or anything else. but may later today.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/21/2021,02/22/2021,1.0,OTH,,,,,,"['Feeling cold', 'Headache', 'Injection site pain', 'Pain']",2,PFIZER\BIONTECH,SYR 1049060,KY,76.0,F,"Rash and welts on arm that appeared 8 days later at injection site- 4 were raised about 1/2 inch, hot and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,02/17/2021,8.0,PUB,,,,,,"['Injection site pruritus', 'Injection site rash', 'Injection site reaction', 'Injection site swelling', 'Injection site warmth', 'Urticaria']",1,MODERNA,IM 1049061,GA,75.0,F,"Disorientation, temporary loss of memory, headache lasting 12-36 hours",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/14/2021,02/21/2021,7.0,PHM,"Lisinopril, Hydrochlorothiazide, simvastatin, Pantaprazole, Vitamin D, Preservision",None,,,none,"['Amnesia', 'Computerised tomogram normal', 'Disorientation', 'Headache', 'Magnetic resonance imaging', 'Transient global amnesia']",2,MODERNA,IM 1049062,MT,17.0,M,No side effects: 17 year old given moderna vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,PVT,none,,,,penicillin,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 1049063,NC,66.0,F,"1.) 1 Day after receiving 2nd Covid19 vaccine had a low dose temperature between 99.6-100.6 degrees, achy joints, and fatigue. 2.) 1-2 days after receiving the 2nd Covid 19 vaccine had a local reaction in left arm where i recieved the vaccine. Itchy , red, warm to touch and sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/22/2021,21.0,PUB,"multi vitamin gummies(2 daily), RX's: levothyroxine, cymbalta, diclofenac, pravastatin, baby aspirin (all 1 daily)",,"hypothyroidism, depression/anxiety, degenerative spinal disease , high cholesterol,","Shingles vaccine-local reaction on arm it was receive in. Red, warm to touch, sore, itchy. Don't know date. Was at least 2 yrs a","latex(mild), prednisone(oral).","['Arthralgia', 'Erythema', 'Fatigue', 'Injection site reaction', 'Local reaction', 'Pain', 'Pruritus', 'Pyrexia', 'Skin warm']",2,MODERNA,IM 1049064,MO,86.0,F,Dose 2 administered 13 days after dose 1 (given 2/5/21 at another clinic),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,SEN,,,,,,['Inappropriate schedule of product administration'],2,MODERNA,IM 1049065,KY,58.0,F,"Nausea, Diarrhea, Headache (4 weeks), Joint Pain (Ongoing), Injection Site Injury - Skin Discoloration/Scab (On Going), Pain Injection Site (Ongoing)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/27/2021,3.0,OTH,"Concerta, venlafaxine, Vitamin D",None,None,,"Steroids, Penicillin, Cipro, Fentanyl","['Arthralgia', 'Diarrhoea', 'Headache', 'Injection site discolouration', 'Injection site injury', 'Injection site pain', 'Injection site scab', 'Nausea']",2,PFIZER\BIONTECH, 1049066,MA,29.0,F,"red, circular rash, warm around the injection site started 11 days after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/11/2021,02/22/2021,11.0,UNK,none,none,none,,"food allergies- apples, pears, peaches, plums, nectarines, cherries, pistachios, hazelnut","['Injection site erythema', 'Injection site rash', 'Injection site warmth']",1,MODERNA,SYR 1049067,MD,35.0,F,"Beginning around 4pm on 2/22/21 I began feeling hot, but did not have a fever (98.8). I was also more tired than usual. Later that evening my injection site was sore, itchy, and raised, like a hive. On 2/23/21 I woke up at about 7:30AM and the injection site was the same as before, but I also had a sore/stiff neck and headache at the base of my skull. The reactions have not warranted a trip to the doctor, but I remember hearing somewhere that the CDC was interested to know about any side effects that may be related to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/22/2021,1.0,UNK,Fluoxetine - 70mg,"Not an illness, but 6 months, 2 weeks postpartum.",Psuedotumor cerebri (diagnosed 10/2014) PTSD (diagnosed 03/2013) Obesity Degenerative arthritis (knees and back) HSV 1 and HSV 2 antibodies (diagnosed 04/2020) Fatty liver (diagnosed 12/2020),"Smallpox vaccine, anaphylaxis, October 2006, patient was 21 years old. Unknown brand name.",Smallpox vaccine,"['Fatigue', 'Feeling hot', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria', 'Musculoskeletal stiffness', 'Neck pain']",2,PFIZER\BIONTECH,IM 1049068,,54.0,F,"Cough, shortness of breath, tachycardia. Transported to ER. Tryptase drawn - 4.6. Symptoms resolved with benadryl",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Cough', 'Dyspnoea', 'Tachycardia', 'Tryptase']",2,PFIZER\BIONTECH,IM 1049069,MD,67.0,F,Red rash developed about one week after injection and is very itchy. It also hurts a little under my arm when I move it.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/20/2021,6.0,PHM,,,,,,"['Axillary pain', 'Pain', 'Pruritus', 'Rash erythematous']",UNK,MODERNA,IM 1049070,NC,73.0,F,FEVER 100 COUGH ACHING MALAISE,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/22/2021,5.0,PUB,VASEPA 2 GM BID VIT D3 2000U QD CELECOXIB200MG QD CO210 100 MG QD MYRBETRIQ 50 MG PANTOPRAZOLE 40 MG PREMERIN 0.4,NONE,HI BP HI CHOLESTEROL GERD HI LIPIDS MILD ASTHMA,,NONE,"['Cough', 'Malaise', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1049071,SD,17.0,M,Patient is 17 yrs 2 months and the Moderna Vaccine has not gotten official approval for those under 18 at this time. Pt did not report any physical symptoms at time of vaccination and none reported back to this writer at this time.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,hyrdoxyzine prn,fever with chills 2/8/2021,"anxiety, adjustment disorder",,none,['Product administered to patient of inappropriate age'],1,MODERNA,SYR 1049072,WI,68.0,F,"Redness and swelling 9cm in diameter on Right Arm 3 days after vaccination, itchiness. Started to improve by Sunday, gone as of Tuesday 2/23/21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/20/2021,3.0,PHM,"Acidophilus, Atorvastatin, Fiber-lax, Hydrochlorothiazide, Levothyroxine, Lorazepam, Magnesium Oxide, Metformin, Potassium, Propranolol",no known,Diabetes,,No known,"['Injection site erythema', 'Injection site pruritus', 'Vaccination site swelling']",1,MODERNA,IM 1049073,MD,50.0,F,Swelling at injection site leaving round circle that itches. Swelling under arm and tenderness in glands under arm. Muscle spasms in arms and chest. Slight nausea.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/23/2021,3.0,PUB,"Pantropozole Zinc Vitamin B1, A, B12",Spinal Stenosis,Severe muscle spasms,,Pennecillin and Iodine,"['Axillary pain', 'Injection site swelling', 'Muscle spasms', 'Nausea', 'Oedema peripheral', 'Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,SYR 1049074,IN,68.0,F,"Discomfort at injection site immediately, Started running a low grade temp at 24 hrs in the 100.+*, with the highest being 100.6. Temp lasted for 12 hrs, with chills & again weird nausea. Experienced headache from 24 hrs for 36 hrs that could be controlled with Aleve.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PUB,,,Hypertension,,Tetracycline & Thimerosol,"['Chills', 'Feeling abnormal', 'Headache', 'Immediate post-injection reaction', 'Injection site discomfort', 'Nausea', 'Pyrexia']",2,MODERNA,IM 1049075,PA,32.0,F,Bulls eye allergic reaction around injection site about 4-5? wide. Area site burning hot and itchy.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/10/2021,0.0,PHM,Lexapro,No,No,,Unknown,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site warmth']",1,MODERNA,SYR 1049076,NM,32.0,F,"1/7 vaccination Within a couple minutes after vaccination, my tongue started to tingle. like pop rocks in mouth. I got extremely nauseous. Within 5 minutes, everything was spinning. Continued progressing. HR 180. Within 10 min, i was in ER. They gave my epi pen but it didn't work right away. They were about to start an epi pen and to knock me out, they gave me Benadryl IV, Pepcid?, and they were 30 seconds from intubating me. My vocal cords; broncho spasms. I slowly started to get better. They monitored me for 7 hours. *Still experiencing, daily, SOB. My voice gets harsh. I run out of breath walking, talking, etc. I use prednisone, 2 inhalers daily; Advere and Rescue inhaler. I also suffer from EXTREME HA since then and am on 2 medications for the HA.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,"zero meds I normally take, did not take the date of vaccination Wellbutrin, Adderall, birth control",,,"COVID 19; 1st vaccination/arm, severe arm pain",,"['Blood test', 'Bronchospasm', 'Dysphonia', 'Dyspnoea', 'Dyspnoea exertional', 'Heart rate increased', 'Immediate post-injection reaction', 'Paraesthesia oral', 'Vertigo']",2,PFIZER\BIONTECH,SYR 1049077,TN,52.0,F,"Left arm is swollen, hot, itching. Patient took Zyrtec and is now putting Hydrocortisone cream to help.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/22/2021,12.0,PHM,NKA,NKA,NKA,,NKA,"['Peripheral swelling', 'Pruritus', 'Skin warm']",1,MODERNA,SYR 1049079,,46.0,M,"Headache, fatigue, joint pain, lethargy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/16/2021,2.0,UNK,"Pravastatin, Aleve, One a Day Multivitamin",None,Psoriasis,,None,"['Arthralgia', 'Fatigue', 'Headache', 'Lethargy']",UNK,PFIZER\BIONTECH, 1049080,WA,76.0,F,Patient developed right facial zoster following her first dose of the Moderna Covid-19 vaccine. She was placed on valacyclovir and gabapentin. She was seen by Ophthalmology due to eyelid involvement and double vision. She was immunized 20 JAN and developed zoster 06FEB.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,02/06/2021,17.0,PHM,"Lisinopril, Metoprolol, ASA, Atorvastatin",,Hypertension Coronary artery disease,,NKDA,"['Diplopia', 'Herpes zoster', 'Ophthalmic herpes zoster']",1,MODERNA,IM 1049081,NV,31.0,F,"left armpit tenderness and node swelling, left nipple sensitivity",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/20/2021,2.0,PUB,,,,,,"['Axillary pain', 'Lymphadenopathy', 'Sensory disturbance']",1,PFIZER\BIONTECH,IM 1049082,KS,40.0,F,"Evening of vaccine starting around 3 pm I had Diarrhea, Nausea, Headache, & Fatigue. Over night I had chills so possible fever but I did not check it. Next morning woke up with Full Body Aches, Very Fatigued, Headache, Injection Site Pain and Swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PVT,"Losartan, Pro Air, Brio, Dexilant, Escitalopram, Atorvastatin, Women's one a day vitamin.",,"GERD, High Cholesterol, Newly Diagnosed with Diabetes.",,"Ampicillin, Phenergan, Zpack make me nauseous and vomit.","['Diarrhoea', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1049083,MD,77.0,F,"Rash, soreness and swelling developed seven days after vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/21/2021,6.0,OTH,,,,,fish,"['Pain', 'Rash', 'Swelling']",UNK,MODERNA, 1049084,MA,56.0,F,"Itchy; Red; hard, warm patch approx 2? x2?",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/20/2021,5.0,PHM,Propranolol Lexapro Vitamin D3 Vitamin C Lysine,,Osteoarthritis,,Guaifenesin,"['Erythema', 'Induration', 'Pruritus', 'Skin warm']",1,MODERNA,SYR 1049085,NM,32.0,F,"12/17 vaccination 12/18 within 24 hours, arm was hurting. Immense pain to arm. Flu like symptoms. Took Motrin. Symptoms lasted for 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/18/2020,1.0,PVT,"Wellbutrin, Adderall, birth control",,,"COVID 19,2nd vaccine 1/7/2021",,"['Influenza like illness', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 1049086,IL,66.0,F,"SWOLLEN LEFT ARM, FEVER, FATIGUE, AND PAIN ON RIGHT SIDE.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/19/2021,01/22/2021,3.0,OTH,,,,,,"['Fatigue', 'Pain', 'Peripheral swelling', 'Pyrexia']",1,MODERNA,IM 1049087,WI,76.0,F,"LEFT ANKLE APPROX 10 DAYS AFTER INJECTION: BUMPY RED RASH, ITCHING, BURNING EVENUALLYSPREAD TO COVER APPROX 4.5"" IN DIAMETER . NOW NO MORE ITCHING OR PAIN BUT LIGHTER RED ANDDRY FLAKY SKIN. BASE OF LEFT THUMB AND RIGHT THUMB"" APPROX 14 DAYS AFTER INJECTION. SAME SYMPTOMS AND CURRENT STATUS. SITE OF INJECTION ON UPPER RIGHT ARM:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/12/2021,9.0,PVT,"METOPROLOL, LISINOPRIL, HYDROCHLOROTHIAZ, SIMVASTATIN, MELOXICAM, VIT D, MULTIVITAMIN AND LORATADINE",NONE,"ELEVATED CHOLESTEROL, HIGH BLOOD PRESSURE, OSTEOARTHRITIS,OVERACTIVE SINUSES (RELATED TO ALLERGIES) ALL SEEM UNDER CONTROL WITH MEDS",,ENVIRONMENTAL ALLERGIES ( DUST- SOME PLANTS),"['Arthralgia', 'Burning sensation', 'Dry skin', 'Erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Joint swelling', 'Pruritus', 'Rash', 'Rash erythematous', 'Skin exfoliation']",UNK,MODERNA,IM 1049088,AZ,39.0,F,"Pain at injection site, immediate but worsened w time, mild the next day. Nausea, chills, malaise, muscle and joint pain-started 15 hours after vaccine and lasted about 4-5 hours Fever up to 101.2- after nausea mostly resolved, lasted overnight Headache -24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/22/2021,1.0,OTH,None,Mild to moderate Cold symptoms prior,None,,Mild allergy to kiwi fruit. Moderate allergy to bee stings.,"['Arthralgia', 'Chills', 'Headache', 'Injection site pain', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1049089,CO,37.0,F,"Pt was here for 1st dose of COVID vaccine. Had received vaccine approx. ten minutes before incident. Pt noted to be slumped in chair, hives noted to forehead, diaphoretic, arms rigid, non-responsive to stimuli, Incontinent of bladder. Pt lowered to ground Zoll applied, COR called. Vital signs: 108/58 100% RA 77 26. Pt given EPI-Pen @ approx. 1352. COR Team arrived, pt mildly responsive. Assisted to Backboard and sent to ER with ED Provider. Pt was monitored in the ED for 3 hours with no recurrent symptoms. Pt advised to follow up with PCP and an allergist and avoid getting the 2nd dose of the covid vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PVT,,,,,,"['Hyperhidrosis', 'Muscle rigidity', 'Posture abnormal', 'Unresponsive to stimuli', 'Urinary incontinence', 'Urticaria']",1,PFIZER\BIONTECH,IM 1049091,NY,70.0,F,"Raised red bumps (size of quarter) on back of forearms. Only one or two bumps, very itchy. Started on left arm, moved to right arm. Small round raised bumps on lower, inside of left forearm (about 3-4.) Then gastoinstestinal symptoms with diarrhea (second bout more severe.) Subtle red coloration on trunk that when stroked with finders turned white. Trunk itching, genitals itching. Hot burning hands, feeling of unease. The symptoms have lasted for days. Injected on 2/5 still having symptoms on 2/23. Taking Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/13/2021,8.0,OTH,Omeprozole,"Gastrointestinal problems, GERD","Immune issues, arthritis, GERD",,"None known, but had an anaphilatic reaction age 32 that need emergency room treatment. For several months after developed small itchy patches on arms. Eventually went away after 6-8 months. Occassionally have small reactions to food. Sever reaction to Red Yeast Rice supplement, causing serious muscle pain.","['Burning sensation', 'Diarrhoea', 'Feeling abnormal', 'Feeling hot', 'Rash papular', 'Rash pruritic', 'Skin discolouration']",UNK,PFIZER\BIONTECH,SYR 1049092,NY,58.0,F,"Was feeling some fatigue, some chills. On day 9 after a shower noticed redness on the injection area, all around it. She looked it up and noticed it was called Covid arm. She called her derm, and told her to put Cortisone cream on it. She left it alone and did not do anything for it. It is day 17 and is a little concerned about the 2nd vaccine. It has lightened up a little but she does still see it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/18/2021,7.0,OTH,"Vitamin D, vitamin Super-C, eye drops for glaucoma.",None.,"Glaucoma, osteoporosis",,None.,"['Chills', 'Fatigue', 'Injection site erythema']",1,MODERNA,IM 1049093,IA,78.0,F,"Had rash, swelling and itching below injection site on 2/9, followed with rash on left midriff and lower right back. This was treated with Triamcinolone 0.5% cream for 4 days, starting 2/15/2021. Rash is gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/09/2021,7.0,PUB,"Lisinopril 20mg, Famotidine 20mg, Preservision Areds 2, Calcium 600mg, D3 50mcg. Turmeric Curcumin 500mg. Cetirizine Hydrochloride 10mg, Clucosamine Chrondronitin, Vit C 1000mg",,RA,,sulfa,"['Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Rash']",1,MODERNA,IM 1049094,NY,40.0,M,"Sweating, nausea, unable to sleep, arm pain, pain in muscles, stiff neck",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,SCH,none,none,none,,none,"['Hyperhidrosis', 'Musculoskeletal stiffness', 'Myalgia', 'Nausea', 'Pain in extremity', 'Sleep disorder']",2,MODERNA,SYR 1049095,CA,47.0,F,"I received the Moderna vaccine on 2/8/21. On 2/16)21 Shingles symptoms occured pain to left scalp on 2/19/21 first rash noted to left scalp , left temple and left eyebrow. I went to urgent care and was Treated with acyclovir and neurontin and on 2/22/21 I went to the ER due to pain and eye swelling and more shingle rashes occuring to left eye lid. I was started on Steroids and stronger pain meds were added.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/16/2021,8.0,OTH,Levothyroxine HCTZ/lisinopril,None,Hypothyroidism Hypertension VSD heart murmur,,None,"['Eye pain', 'Eye swelling', 'Herpes zoster', 'Pain of skin', 'Rash', 'Visual acuity tests']",1,MODERNA,IM 1049096,IN,78.0,F,Week after shot my arm started to itch. and my injection site was raised and kept itching. I tried not to scratch it.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,02/02/2021,7.0,OTH,"trilogy, lisinopril, rosuvastatin , baby aspirin , magnesium, D2, Zinc, multivitamin, B Complex, Cinnamon,",NO,High blood pressure,,"formaldehyde, Sulphur,","['Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 1049097,,50.0,M,"Flushed, pale, diaphoretic, bradycardic. Epi administered and RRT called. Admitted to hospital with cardiac cath - likely unrelated.",Not Reported,,Not Reported,Yes,5.0,Not Reported,,01/11/2021,01/11/2021,0.0,PVT,,,Underlying chronic heart disease,,,"['Bradycardia', 'Catheterisation cardiac', 'Flushing', 'Hyperhidrosis', 'Pallor']",2,PFIZER\BIONTECH,IM 1049098,MA,81.0,F,"REDNESS, ITCH, HOT AT INJECTION SITE FOR 5 DAYS AND COUNTING USED CORTISONE OINTMENT FOR ITCH WITH EFFECT",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/19/2021,7.0,PHM,METOPROLOL SUCCINATE. APPLE CIDER VINEGAR AMLODIPINE TUMERIC PRAVASTATIN BABY ASA VIT D,NONE,HYPERTENSION TRIPLE CABBAG ARTHRITIS,,NONE,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 1049099,ND,34.0,F,"Approximately 5 minutes after injection pt became dizzy, reported double vision, and left sided weakness. VSS. Pt was sent to on-site ER for further evaluation. ER workup was ""unremarkable"" per ER notes and ""likely due to low blood pressure or some form of anxiety."" Symptoms had resolved by end of ER visit and she was sent home with general",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,PVT,"alprazolam, fluoxetine, propranolol, bupropion, Mirena IUD, clobetasol, nifedipine, prenatal vitamins, albuterol prn",,"Hypogammaglobulinemia, hypertension, depression, mild reactive airways disease",,"penicillin, levaquin","['Anxiety', 'Blood magnesium normal', 'Diplopia', 'Dizziness', 'Full blood count normal', 'Hemiparesis', 'Hypotension', 'Metabolic function test']",1,MODERNA,IM 1049100,AL,77.0,M,"Patient received 1st dose on 01/18/2021, returned to clinic and presented for 2nd dose. Date written on 2nd dose Immunization 66form was 1/1/2021. Patient received 2nd dose of Moderna on 02/04/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/04/2021,0.0,PUB,unknown,unknown,Heart disese,,NKDA,['Inappropriate schedule of product administration'],2,MODERNA,IM 1049101,IN,71.0,F,"Aching muscles all over (like with severe flu) Severe migraine headache--sensitive to light, noise, movement--causing vomiting Dizziness/lightheaded Dr. recommended alternate use of Tylenol and Advil and prescribed anti nausea medication. 3 days of reaction. Am still lightheaded and dizzy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PUB,Minocycline 50mg 81 mg Aspirin Citracal (500 mg calcium) Triple Flex (Glucosamine/Chondroitin) Flaxseed Oil,No illness,No,,Adverse reactions to Cefdinir Doxycycline Ciprofloxacin Statins,"['Dizziness', 'Hyperacusis', 'Influenza like illness', 'Migraine', 'Pain', 'Photophobia', 'Vomiting']",UNK,MODERNA, 1049102,CA,32.0,F,"Raised, warm welt (approximately 2 inches diameter) at injection site, moderate itching at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/22/2021,7.0,UNK,Multivitamin Vitamin C B-12 Iron Wellbutrin Zoloft Birth control,None,"Depression, anxiety",,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site urticaria', 'Injection site warmth']",1,MODERNA,SYR 1049103,MI,52.0,F,Red itchy rash around injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/23/2021,3.0,PUB,none,none,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash']",2,MODERNA,IM 1049104,MO,37.0,M,Full body bump rash,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/21/2021,3.0,PVT,Full body bump rash,,,,Penicillin,['Rash'],2,PFIZER\BIONTECH,SYR 1049105,PA,64.0,F,"Moderna COVID-19 Vaccine EUA 2 days after receiving the vaccine I woke up with facial tingling, numbness which extended around my ears. It comes and goes.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/27/2021,2.0,PVT,"Symbicort Inhaler, Flonase Nasal Spray, Gabapentin",itching,"asthma, osteoporosis, ocular migraine",,"Sulfa, Cipro, Levaquin, Ampicillin, Cefdinir","['Hypoaesthesia', 'Magnetic resonance imaging brain', 'Paraesthesia']",1,MODERNA,IM 1049107,NC,43.0,F,"Patient started to complain of chest tightness and coughing at 1545, was hot with mask on, used her albuterol rescue inhaler because thought it was asthma acting up. No relief after 2-3 minutes, Doctor notified to evaluate. Epinephrine recommended, EMS called. Epinephrine administered at 1558. Respiratory relief with epinephrine, patient started itching chest, back and arms. EMS arrived at 1620.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,PUB,albuterol and unknown,unknown,asthma,,unknown,"['Asthma', 'Chest discomfort', 'Condition aggravated', 'Cough', 'Feeling hot', 'Pruritus']",1,MODERNA,IM 1049108,OK,36.0,F,"Approx 10 minutes after receiving the vaccine client started c/o feeling hot inside and outside of body, sweating on neck, and light headed, clamminess to hands. Vitals monitored. no medications given.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,OTH,"Trazadone, and Tanazepam both for sleep",none,None,client has become dizzy and nauseated after a vaccine before,NKDA,"['Cold sweat', 'Dizziness', 'Feeling hot', 'Hyperhidrosis']",1,PFIZER\BIONTECH,IM 1049109,MN,23.0,F,"Patient had a first time seizure and she has no other risk factors for seizure. Of note, the patient had COVID-19 infection three months ago and received her first dose of the Moderna vaccine three weeks ago",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,02/23/2021,27.0,UNK,Singulair 10 mg daily Levalbuterol 1-2 puffs q4hrs prn levonorgestrel (Kyleena) 19.5 mg IUD,,Mild intermittent asthma,,No known drug allergies,"['Blood glucose increased', 'Full blood count normal', 'Human chorionic gonadotropin negative', 'Metabolic function test normal', 'Seizure']",UNK,MODERNA,IM 1049110,MT,87.0,M,Left deltoid area red with rash. Rash also present below deltoid to elbow and just below right scapula. Patient reports itching of entire upper outer arm and across midsection of his back. Lotion and hydrocortisone cream applied.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/22/2021,5.0,PUB,,,,,None,"['Injection site erythema', 'Injection site rash', 'Pruritus', 'Rash']",2,MODERNA,IM 1049111,,47.0,F,Dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/19/2021,01/19/2021,0.0,PVT,,,,,,['Dizziness'],2,PFIZER\BIONTECH,IM 1049112,CA,90.0,F,"Weak, upset stomach, and acid reflux",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/21/2021,02/22/2021,1.0,PVT,"Ondansetron, warfarin, azelastine, fluticasone, buspirone, hydroxyurea, nortriptylin, alecensa, levothyroxin, montelukast, losartan, atorvastatin, metoprol",Cancer,Cancer,,Dairy & penicillin,"['Abdominal discomfort', 'Asthenia', 'Gastrooesophageal reflux disease']",1,PFIZER\BIONTECH,SYR 1049113,OR,77.0,M,"1/23/21 First shot: sore arm only. 2/20/21 Second shot in afternoon. By evening, fever 102.8 (then took Tylenol and fever reduced to 101). Fever, nausea, severe leg pain, moderate low back pain, severe fatigue. 2/21 morning through evening: 101 to 102, nausea, fatigue. 2/22 fatigue, temp 100 to 101. 2/23 fatigue, low temp 99.0.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,OTH,,,Cancer in remission,,,"['Back pain', 'Fatigue', 'Limb discomfort', 'Nausea', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 1049114,MA,50.0,F,Body aches upon waking at 6am 2/11. arm was also sore.By 4:30 pm on 2/11 I felt awful with a temp of 102.7. I did not medicate and felt better by Saturday 2/1. I had temps off and on the entire time and extreme fatigue.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/11/2021,1.0,PUB,"lisinopril , claritin , synthroid",none,"hypothyroidism , high blood pressure",,none,"['Body temperature increased', 'Fatigue', 'Feeling abnormal', 'Pain', 'Pain in extremity']",2,MODERNA,IM 1049115,MI,29.0,F,Itchy red hives and rash all over body and face. Painful joints. Swelling so bad it is Painful to walk on feet and use hands.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/21/2021,3.0,OTH,"Armor thyroid, falmina oralcontraceptive",No,Hashimoto?s,,No,"['Arthralgia', 'Gait disturbance', 'Pain in extremity', 'Pruritus', 'Rash', 'Swelling', 'Urticaria']",2,PFIZER\BIONTECH,SYR 1049116,MI,72.0,M,"Client inadvertently given Modern Covid-19, after receiving Pfizer Covid-19 3 weeks ago.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,PUB,,,,,,"['Inappropriate schedule of product administration', 'Interchange of vaccine products']",2,MODERNA,IM 1049117,NE,85.0,F,I had severe chills on Friday and my arm was feverish and sore until this morning. I also had weakness and dizziness.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PUB,levothyroxine 50 mg every other day 75 other days synthroid acytomil 5mg fish oil 1000 4x daily half capusle of miralax every day 2 fiber gummies muiltvitamin 1 daily caltrate 600 +D 2x daily glucosamine condratent 1 daily warfarin 5,hernia surgery January 17th,,,eggs chicken turkey aspirin benadryl sulfa Zoster vaccine actenol evista Tricor crestor lovenox injections heparin arixtra levothyroxine fozenex,"['Asthenia', 'Chills', 'Dizziness', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 1049118,NH,67.0,M,high blood pressure for several days afterword,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/14/2021,2.0,OTH,omeprazole 10 MG per day,none,none,,none,['Hypertension'],1,MODERNA,IM 1049119,AZ,27.0,F,I got the vaccine felt completely great that night. Next day i woke up queasy.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,UNK,,,,,,['Nausea'],1,PFIZER\BIONTECH,SYR 1049120,TN,76.0,F,"I got extremely hot. I undressed quickly and got into my bed. My head moved from side to side with out my control. I was swallowing rapidly. I was awake and knew what was happening. I don?t know how long it lasted. When the episode was over, I went to sleep. I awakened in about 3 hours, went to the rest room, and returned to bed. I was uneasy and thought I might fall. I slept another three hours and went to the bathroom again. I felt a little better. I got up in about two more hours and felt a little better. Didn?t feel good all day and my arm was really sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,OTH,"Diltiazen, solifenacin succinate, ferrous sulf, aspirin, montelukast, rosuvastatin calcium, miralax, B12, caltrate, Alendronate sodium,",None,"High blood pressure, high cholesterol, kidney problems,",,"Tramadol, Sulfa drugs, latex, codeine, minocycline, doxycycline, benicar, benazepril, terazosin","['Aerophagia', 'Balance disorder', 'Dyskinesia', 'Feeling hot', 'Limb discomfort']",1,MODERNA,IM 1049121,NY,45.0,F,"102-103 Fever, chills, flu like symptoms, and 36 hours later was better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,WRK,"Synthroid, multivitamins, Vitamin D, red yeast rice pills 1200 mgs, cranberry pills.",None,None,,"Erythromycin, MRI dye, and insect venom.","['Feeling cold', 'Influenza like illness', 'Pyrexia']",2,MODERNA,IM 1049122,CA,73.0,F,"I woke up in the night (approx. 2:00 a.m.) with freezing cold feet and hands. This continued throughout the night (I could not get warm) until I fully awoke at 7:00 a.m. when took my temperature. That was 100.6. After speaking to my doctors office, I took Tylenol and my temperature reduced to 99.8 for the rest of the day. By 9:00 p.m., it had gone down to normal without medication. I still suffered from exhaustion and seem to have ongoing digestive issues.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,02/10/2021,1.0,OTH,"Eye vitamin, but not taken on this day.",None.,None.,,Internal iodine.,"['Body temperature increased', 'Fatigue', 'Functional gastrointestinal disorder', 'Peripheral coldness']",1,MODERNA,SYR 1049123,IL,51.0,U,FEVER AND HEADACHE,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/15/2021,02/16/2021,1.0,OTH,,,,,,"['Headache', 'Pyrexia']",1,MODERNA,IM 1049124,NY,70.0,F,"symptoms since her dose of Covid Moderna vaccine on Jan the 25th. In the first 1-2 days she had the usual soreness at the injection site but nothing else. Then, about a week after it, her arm in the area of the injection site gradually became red and warm and indurated slightly without pain About the same time she noted a sense of fatigue and feverishness. Her temp was 100.4 or thereabouts. This persisted for a couple of days with no fever in the morning or midday but feverishness in the late afternoon /early evening and the temp always between 100.2 100.4. The redness of the upper arm increased to an area of about 2x3 inches. On Feb 2nd or 3rd she began a ten day course of penicillin 500mg qid x 24 hr then 250 mg qid x 9 days. The redness, induration and warmth improved and returned to normal gradually over the next 5 days or so. She stopped the penicillin on Feb 12th. Her temperatures in the late afternoons during the time of taking the penicillin were mostly between 100 and 100.4 and in the final couple of days of taking the penicillin it seemed to be resolving. The day after the penicillin it was 99. However, on the 15th it was 101. and since then it has been about 100.4 Her arm still appears normal . Other symptoms she is complaining of bilateral lateral hip pain. She feels quite achy. She believes this started since the vaccine dose I believe she may have had some complaints prior to it. No joint complaints, no upper extremity symptoms other than as above. No HA, ST. She has had what she describes as ""spasms in her chest"") which has improved but presented about the same time as the arm and temperature did. No Gi symptoms. Her activity has not been curtailed. Neck pain bilat was noted starting the end of December without other symptoms and wo any hx of trauma and did not feel like a typical wry neck. No travel other than for the vaccine, to the grocery store and rarely to another shop. No exposures to anyone other than our grandchildren, son and dau-in-law who are in our ""bubble"" (the granddaughter attends an out door preschool where they all wear masks and have had no covid cases.Patient walks weekly out doors with a friend. She sees her mother who at 96 resides at home and sees no one. She had a NP swab for Covid PCR test yesterday (the 17th) which is reported this am as ""undetected"". An evaluation with Doctor led to blood work showing wbc 9.2, hgb 11, plt 546k, ESR 74, CRP 67 a diagnosis of PMR was tentatively made and she was started on prednisone 15 mg /d. Improvement was seen at 24 hours and persisted. Neck pain is 80% better as well. Questions: Did the vaccine play a role in exacerbating a preceeding condition of PMR? If the neck pain is a red herring, did the vaccine cause PMR?",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/01/2021,7.0,PVT,none,neck aching starting about 12 /20/2020,none,,none,"['Arthralgia', 'C-reactive protein increased', 'Fatigue', 'Haemoglobin decreased', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site warmth', 'Muscle spasms', 'Neck pain', 'Pain', 'Platelet count increased', 'Polymyalgia rheumatica', 'Pyrexia', 'Red blood cell sedimentation rate increased', 'SARS-CoV-2 test negative', 'White blood cell count normal']",1,MODERNA,IM 1049125,TN,50.0,M,Moderna COVID-19 Vaccine EUA Pudendal nerve/testicular pain Aggravation of peripheral neuropathy Currently treating the testicular pain through physical therapy that was already doing for pelvic floor. But this a whole new problem. Moderate increase in otherwise existing peripheral neuropathy in feet legs and hands. Appointment with urologist next week. Testicular pain began about six to seven hours after shot and has remained for a week now.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/16/2021,0.0,OTH,"Gabapentin, multi vitamin, Lysine.",More recent pelvic floor/prostrate issues,Peripheral neuropathy,Neuropathy tetanus shot 37. Do not know brand name.,"Penicillin, coprocessor, contrast dye","['Neuropathy peripheral', 'Pudendal canal syndrome', 'Testicular pain']",1,MODERNA,SYR 1049126,NY,66.0,M,"Tested 1/14/2021 positive, fever & malaise 1/19-21/21, admitted with severe CoVID pneumonia 1/22/2021 � 1/25/2021, required supplemental O2 1/22-24.",Not Reported,,Not Reported,Yes,,Not Reported,,01/08/2021,01/12/2021,4.0,UNK,,,,,,"['COVID-19 pneumonia', 'Malaise', 'Nucleic acid test', 'Oxygen saturation', 'Oxygen saturation decreased', 'Pyrexia', 'Systemic inflammatory response syndrome']",1,MODERNA,IM 1049127,,41.0,F,Patient became itchy. Given 25 mg diphenhydramine suspension. EMS took vital signs and checked BS. Patient monitored from 10:030-11:05.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/18/2021,0.0,UNK,,,,,,['Pruritus'],1,PFIZER\BIONTECH,IM 1049128,NC,58.0,F,"Around 1625 patient started complaining of tingling and itching around the mouth. Dr advised to evaluate patient. Benadryl ordered. BEnadryl 25 mg given IM at 1638. 1650 patient reported improved symptoms on Benadryl, patient declined EMS. Patient states has epipen at home if needs. Was advised to call 911 if symptoms worsen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,PUB,unknown,unknown,unknown,,unknown,"['Oral pruritus', 'Paraesthesia oral']",1,MODERNA,IM 1049129,,48.0,F,"I received the Vaccine on 2/18 .At 22:00 I had chills and low grade Fever. Middle of the night I felt fatigue and body aches, dull Headache. In the morning I was nauseus. The symptoms lasted for 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1049130,,52.0,M,"Patient reported throat irritation, which started a few minutes after receiving vaccine. Symptoms improved at 15 minutes. Had similar reaction with flu vaccine. 14:00 Patient called. Reported he took diphenhydramine. Throat irritation decreased. Reports headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,UNK,,,,,,"['Headache', 'Throat irritation']",1,MODERNA,IM 1049131,AZ,39.0,M,"Very, tight chest and very difficult to take a deep breathe. Measured O2 levels and high 90's - 98.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/23/2021,1.0,PUB,None,None,None,,Sulfa,"['Chest discomfort', 'Dyspnoea', 'Oxygen saturation normal']",2,PFIZER\BIONTECH,IM 1049132,LA,41.0,F,"Woke at 3am with severe body aches, headache, fever of 101.3 and nausea. Symptoms persisted throughout the day with max temp of 103. Also had swelling at injection site with redness the size of a baseball and extreme tenderness to upper arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PVT,None,None,Asthma,,None,"['Headache', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1049133,IN,71.0,F,4 hours of rapid heart rate 14 hours of irregular heart beat 24 hours of diarrhea elevated blood pressure (continuing) Saw my PCP to evaluate reactions and advise whether to get second vaccine dose),Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,PVT,none,none,none,,"Penicillin, latex, sweet potatoes","['Blood pressure increased', 'Diarrhoea', 'Heart rate increased', 'Heart rate irregular']",UNK,MODERNA, 1049134,TN,55.0,F,"Severe headache woke me from sleep around 12:05 am - started taking extra strength Tylenol every 4 hours. This lasted roughly 12-14 hours after onset. Swelling of left side of neck, shoulder, and under left arm with noticeable inflammation of the Subraclavical Lymph Node. Swelling of the neck region has gone down some, but still quite significant along the collar bone and lymph node",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,OTH,Levothyroxine 0.075 mg Lovastatin 10 mg Liothyronine 5mcg,None,Hypothyroidism Oesteoarthritis,Had mild swelling along collar bone and supraclavical lymph node,KNA,"['Headache', 'Injection site joint swelling', 'Injection site lymphadenopathy', 'Swelling']",2,MODERNA,IM 1049135,NY,63.0,F,Subjective tingling to tongue and questionable subjective swelling but no visible swelling no hives no trouble breathing. Spontaneously began to resolve in a couple of minutes. Advised to see allergist before second dose.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/23/2021,02/23/2021,0.0,UNK,,,,,"PCN, Cipro, Shellfish, Statins",['Paraesthesia oral'],UNK,PFIZER\BIONTECH, 1049136,AZ,69.0,F,"Arm burning at site and achy, malaise, Sunday I work up and my face felt hot and cheeks red and felt swelling, my cheek and neck and felt like it was going into my nose and up to my eyes, and I had hoarseness as well. I had difficulty breathing so I went to the ER. I was given an IV and they observed me.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/14/2021,0.0,PVT,"Keflex antibiotics, Metoprolol,",no,"no, just hip",,"Benadryl, Penicillin, chocolate, demurral","['Dysphonia', 'Dyspnoea', 'Erythema', 'Eye swelling', 'Hot flush', 'Injection site pain', 'Malaise', 'Nasal congestion', 'Swelling', 'Swelling face']",1,MODERNA,IM 1049137,IL,70.0,M,"not sure if pt had Pfizer or mederna vaccination. pt had myalgias, arthralgias, and intense fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PVT,Current Outpatient Medications on File Prior to Visit Medication Sig Dispense Refill ? ESCITALOPRAM 10 MG tablet TAKE 1 TABLET (10 MG TOTAL) BY MOUTH DAILY. (Patient taking differently: Take 10 mg by mouth nightly. ) 90 tablet 1 ? furosemid,"cardiac eval and hospitalization earlier in month. episode on drive to appt of impaired consciousness, thought to be related to benzodiazepine use.","Past Medical History: Diagnosis Date ? A-fib (CMS/HCC) 03/2018 has had 3 cardioversions, went to St Joseph Hosp Breese 4/2/2018 for dyspnea ? Acute diverticulitis 5/29/2019 ? Acute low back pain with right-sided sciatica 1/13/2020 ? Anesthesia complication slow to wake after rotator cuff surgery, was told to go have sleep study and was found to have OSA ? Anxiety 4/27/2020 ? Arthralgia of both knees 5/16/2019 ? Arthritis OA, takes tramadol for arthritis pain, generally takes the tramadol at night ? Benign prostatic hyperplasia with urinary obstruction 5/30/2019 ? Blood clot in vein 2006 After taking a long bus ride was dx with blood clot in ankle 2006, ? CAD (coronary artery disease) 12/26/2018 ? Cervical strain 1/13/2020 ? Chronic anticoagulation 7/13/2018 ? Colitis ? Depression 6/10/2020 ? Elevated LFTs 6/19/2019 ? Elevated PSA 2020 ? Factor 5 Leiden mutation, heterozygous (CMS/HCC) 12/22/2014 ? HTN (hypertension) ? Malignant neoplasm of prostate (CMS/HCC) 4/26/2020 ? Mixed hyperlipidemia 9/9/2019 ? Motor vehicle accident 1/13/2020 ? Obesity (BMI 30-39.9) ? OSA (obstructive sleep apnea) 5/23/2017 ? PE (pulmonary thromboembolism) (CMS/HCC) 2/17/2017 ? Postherpetic neuralgia 7/27/2020 ? Prostate cancer (CMS/HCC) ? Reactive airway disease without complication 12/3/2019 ? Shingles ? Tendinitis of ankle 2/17/2020 ? Wears glasses reading glasses",,none,"['Arthralgia', 'Fatigue', 'Myalgia']",UNK,MODERNA, 1049138,,52.0,M,"A few minutes after receiving the vaccine, patient reported 1/10 chest pressure to left chest, to left shoulder, improving after 15 minutes. No nausea, light headedness. Non-smoker, no HTN or DM.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/20/2021,0.0,UNK,,,,,,['Chest discomfort'],2,PFIZER\BIONTECH,IM 1049139,,17.0,F,"Dad says 5-10 minutes after vaccine patient started having symptoms. Patient said it felt like she couldn't breathe, like her throat was closing off. Patient walked with staff member to EMS ambulance ~50 feet away.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/20/2021,0.0,UNK,,,,,,"['Dyspnoea', 'Immediate post-injection reaction', 'Throat tightness']",1,PFIZER\BIONTECH,IM 1049140,IA,61.0,F,"Pain at injection site first 4 days. No fever or swelling. On day 5 there was intense itching and a band of raised, red, warm-to-the-touch irritation appeared. Benadryl helps to ease the itching. It looks like a gigantic hive.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/22/2021,4.0,PVT,Aimovig Allopurinal Aprazolam B-Complex Benadryl Clopidogrel Combivent Respimat Fluoxetine HCL Furosemide Ibuprofen Iron Levothyroxine Lyrica Montelukast Prenatal Vitamin Propranolol Symbicort Triamterene/HCTZ Tylenol Vitamin D2 Vitamin D3,None,Fibromyalgia Congestive Heart Failure Lymphadema Arthritis Chronic Pain Use motorized wheelchair now,,"Dye used in eye at time of stroke - don't know the name of it, but benedryl helped the reaction.","['Injection site irritation', 'Injection site pain', 'Injection site pruritus', 'Injection site urticaria', 'Injection site warmth']",2,MODERNA,IM 1049141,IL,59.0,M,HEADACHES AND CHILLS THROUGHOUT BODY.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/15/2021,02/16/2021,1.0,OTH,,,,,,"['Chills', 'Headache']",1,MODERNA,IM 1049142,OH,75.0,F,"covid arm, beginning 7 days after shot and lasting for 3-4 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,02/02/2021,7.0,PHM,,,,,,['Injection site reaction'],1,MODERNA,IM 1049143,NY,65.0,F,"About 6 PM the day I received the vaccine, the arm started to become extremely sore. It was achy feeling and it radiated down to my wrist. This lasted until Sunday and it started to fade. Today it is just some soreness left at the injection site. I was taking OTC Acetaminophen 500MG between 100 MG for pain. It was difficult to sleep due to the pain. I was also putting cool compresses on it. The pain worse when I was trying to clean my car and shovel the snow. However the cold compress and stretching did help with some of the pain. I also felt agitated for different periods times after vaccination, I felt like my hormones were out of whack and I wanted to ""bite someone's head off"" this lasted for about an 1 hour or so. I also had mild headaches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,PHM,"Advil as needed for pain/headache, Azelastine HCl nasal spray .1% (137 MCG per spray), 2 sprays in each nostril twice a day, Vitamin Super B complex daily, Vitamin D3 2000 IU daily, Vitamin C with rose hips 250 MG daily, Pepcid AC 10 MG as",,allergic rhinitis (normally seasonal),,,"['Agitation', 'Feeling abnormal', 'Headache', 'Injection site pain', 'Pain in extremity']",1,MODERNA,SYR 1049144,,29.0,F,"Lightheaded, short of breath, tightness across chest, unsteadiness in legs, cloudy brain. Went to ER with labs done (tryp 4.8). Discharged.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/26/2021,01/26/2021,0.0,PVT,,,,,,"['Chest discomfort', 'Dizziness', 'Dyspnoea', 'Feeling abnormal', 'Gait disturbance']",2,PFIZER\BIONTECH,IM 1049145,KY,,F,"I experienced chills, fever, horrible joint pain and muscle pain. I also had the worst diarrhea for days. I went to see my PCP where lab work, stool sample, liver function test and flu test was performed which were negative. After two weeks I had a UTI, but think it was from all the diarrhea I experienced. A Covid-19 test was performed which was negative. I also received Iv fluids due to my dehydration. I missed two weeks of work due to my symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,PVT,"Toprol 50mg, Baby aspirin OD, Blackcohosh medication",,"Tachycardia, factor five leden",,,"['Arthralgia', 'Chills', 'Dehydration', 'Diarrhoea', 'Impaired work ability', 'Laboratory test', 'Liver function test', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test', 'Stool analysis', 'Urinary tract infection']",1,MODERNA,IM 1049146,UT,71.0,F,"Loss of control of my bladder. Couldnt walk. Taken to urgent care. Cardiogram was done. BP was over 300. Taken to Hospital, CAT scan confirmed that I was NOT having a stroke. after 4 days I was fine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/11/2021,1.0,PUB,Montelukast sodium amlodipine Besylate Carvedilol Rosuvastatin Calcium Lantus Insulin Humalog Insulin Hydrochlorothiazide Valsartan Xarelto Presevision Centrum Baby Aspirin,No,Afib Diabetes,,Penicillin,"['Blood pressure increased', 'Blood pressure measurement', 'Computerised tomogram', 'Gait inability', 'Urinary incontinence']",1,MODERNA,SYR 1049147,CA,77.0,M,"Patient had vasovagal reaction that required nurse to lay on floor and elevate feet. Patient's head slumped and nurse immediately noticed and placed in lying position with feet elevated. patient regained awareness and was A&Ox3, but required O2. patient was monitored and left under own power with out assistance. Patient given ER precautions and states understanding.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,,,,,"['Oxygen therapy', 'Presyncope']",1,PFIZER\BIONTECH,IM 1049148,CA,72.0,F,"Itchy rash, 1 1/2 ? x 3?, inflamed, red",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/21/2021,7.0,PHM,Claritin,None,Seasonal allergies,,"Isopropyl alcohol, nickel, some fruits","['Dermatitis', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,SYR 1049149,PA,47.0,F,Itchy and bumpy face started on February 17th. Woke up on the 18th with a swollen face and continued with bumps and itchiness. Went to Urgent Care on February 20th and started steroids. The swelling increases while I am sleeping.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/17/2021,9.0,PVT,One a day D3 Lexapro Bioton,Ibs-d,Ibs-d,,Cipro Erithromyacin,"['Pruritus', 'Rash', 'Swelling face']",2,PFIZER\BIONTECH, 1049150,MI,85.0,M,"Feb 9, patient was light-headed, as if he was going to faint. He did not have appetite. Evening of Feb 9, started vomiting large amounts of blood. Ambulance took him to hospital. CT scans showed abnormally enlarged pancreas. Patient aspirated blood and was put on a ventilator for 48 hrs. Endoscopic ultrasound showed ulcers in stomach that appear to have been bleeding, which were clipped and shot with epinephrine. After being treated for ulcers, patient developed blood clots in leg and lungs. It is almost two weeks since initial emergency, and patient is still showing sings of internal bleeding (low blood pressure, low hemoglobin, blood in stool). Still no firm explanation for continued bleeding. Before adverse event on Feb 9, patient did not report other symptoms from shot, however, he did show unusual signs of large bruising on his arm. Patient is currently at Hospital. Blood thinners are being discontinued, but patient still has blood clots.",Not Reported,,Yes,Yes,12.0,Not Reported,N,01/31/2021,02/09/2021,9.0,OTH,"Amlodipine, aspirin, Metaprololtartrate, prasterone, testoster testosterone, allopurinol, citrizine, vitamin D3, hydrochlorothiazide, lantus, metformin",,"CLL, Diabetes, hypertension",,May be allergic to penicillen,"['Aspiration', 'Computerised tomogram abdomen abnormal', 'Contusion', 'Decreased appetite', 'Deep vein thrombosis', 'Dependence on respirator', 'Dizziness', 'Endoscopic ultrasound abnormal', 'Gastric ulcer haemorrhage', 'Haematemesis', 'Haematochezia', 'Haemoglobin decreased', 'Hypotension', 'Internal haemorrhage', 'Mechanical ventilation', 'Pancreatic enlargement', 'Pulmonary embolism', 'Thrombosis']",1,PFIZER\BIONTECH,SYR 1049151,PA,26.0,F,"Developed red hives around neck and chest at 4 minutes post vaccination. Gave 25 mg tablet Benadryl PO. At 7 minutes post vaccination had c/o feeling warm and having a headache. Vitals taken, vitals repeated 5 minutes later, still had c/o headache and feeling warm, chest hives redness was decreasing however, she was starting to itch on her back. At 11:15 an additional 25 mg tablet of Benadryl PO was given.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,WRK,Trilosprintec,none,none,,none,"['Feeling hot', 'Headache', 'Immediate post-injection reaction', 'Pruritus', 'Urticaria']",UNK,PFIZER\BIONTECH,IM 1049153,IL,58.0,M,ARM SWELLING AND HEADACHES,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/16/2021,02/17/2021,1.0,OTH,,,,,,"['Headache', 'Peripheral swelling']",1,MODERNA,IM 1049154,MD,56.0,F,"Since the vaccine, I have had intermittent tingling of the tips of my fingers. It is all day, including during the night but it comes and goes. Both hands have the tingling finger tips.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/25/2021,1.0,PVT,"Synthroid, Skyrizi, Calcium, Vit D, Liver Focus, DIM, Propidren, Cholestene, Tumeric, Probiotic",osteopenia,"Psoriasis, Hypothyroidism",,"PTU, Tapazole",['Paraesthesia'],2,PFIZER\BIONTECH,IM 1049155,AZ,68.0,F,About four days after the shot I started having a runny nose and a cough with lots of clear mucus from both. Then it went down to my lungs and my lungs really hurt . I do have asthma so maybe that?s a part of it? It just seems strange that I was coughing so much and gave me a headache. Then about six days later I got an attack of IBS. I haven?t had an attack like that for two years. Maybe it?s all a coincidence? Also about 3-4 days after shot I had a herpes outbreak.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/10/2021,4.0,UNK,,,,,,"['Condition aggravated', 'Cough', 'Headache', 'Herpes virus infection', 'Pulmonary pain', 'Rhinorrhoea']",1,PFIZER\BIONTECH,IM 1049156,,65.0,F,"In the pt's words "" received our second covid-19 vaccination on Sunday. I got my vaccination about 10:00. By 8:00 PM I was not feeling well. Had all of the side effects, chills, fever, muscle aches, joint pain and a wicked headache. Monday was the same minus the headache. Today, still have joint pain and feel very weak. The nurse that gave us our vaccinations said that if we experienced any of the side effects, we should let our primary physician know. Hopefully all of this is normal and I will be back to my normal self soon. I am concerned because most of the information I have read says 24 hours and effects should be gone. Not so with me. Hope all is well with you and your family. "" Spoke w/ pt on phone and she stated her s/s are subsiding, other than the arthralgia, RN",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,PVT,,,,,,"['Arthralgia', 'Asthenia', 'Chills', 'Headache', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1049157,PA,35.0,F,"Muscle and severe joint pain, lumbar, thoracic, and cervical spine pain (every vertebrae in my spine hurt like my car accident was yesterday), severe headache with horrible eye pain, nausea, injection site pain and arm weakness, sweating at night, diarrhea, sharp chest pains (like when I had covid), soft tissue between ribs hurt, gerd (reflux, over full feeling, gas, heartburn, sour stomach, pain when eating), extreme exhaustion, inability to do daily activities or go to work for one week",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,PVT,"Topamax 75mg, amitriptyline 10mg, gabapentin 100mg (as needed 3x daily), hyoscamine (as needed), rizatriptan (as needed for migraine up to 3x/week)",,"Herniated discs/chronic pain from car accident, chiari 1 malformation, functional gi disorder, long covid complaints/symptoms, chronic migraines and headaches","Similar to dose 2, not as severe",Penicillins,"['Abdominal distension', 'Arthralgia', 'Back pain', 'Chest pain', 'Diarrhoea', 'Dyspepsia', 'Eye pain', 'Fatigue', 'Flatulence', 'Gastrooesophageal reflux disease', 'Headache', 'Impaired work ability', 'Injection site muscle weakness', 'Loss of personal independence in daily activities', 'Musculoskeletal chest pain', 'Myalgia', 'Nausea', 'Neck pain', 'Night sweats']",2,PFIZER\BIONTECH,SYR 1049158,SD,64.0,F,"Itchiness at injection site few days after injection and then on day 8 a large area of redness, hardness and warmth in the skin at the injection site. No treatment. Symptoms gone by day 10.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/21/2021,8.0,UNK,,,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 1049159,SC,42.0,F,"Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, increased HR and BP. Given Benadryl, was monitored and released. She felt normal from 2/15 to 2/18. Then on 2/19 she felt dizzy, tongue felt fuzzy, heart rate erratic. Came to the ED. Had normal labs. Vitals normalized. Went home. Thereafter from 2/19 to 2/23, felt dizzy, had erratic heart rate, was light headed and was having a hard time focusing. Came back to the ED on 2/23 and had a HR of 135 and BP of 177/108. Got IV fluids and vistaril. Her HR improved to 119 and her BP improved to 161/98.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/14/2021,02/14/2021,0.0,OTH,xyzal,none,none,,penicillin,"['Blood pressure increased', 'Brain natriuretic peptide normal', 'Disturbance in attention', 'Dizziness', 'Fibrin D dimer normal', 'Full blood count normal', 'Heart rate increased', 'Heart rate irregular', 'Human chorionic gonadotropin negative', 'Laboratory test normal', 'Paraesthesia oral', 'Rash', 'Troponin normal', 'Urine analysis normal']",2,PFIZER\BIONTECH,IM 1049160,AZ,37.0,F,"0843: POST VAC. ADMIN. C/O: DIZZINESS, NAUSEATED, SLUGGISH FEELING. VS: 98.3, P: 78, R: 18; BP: 128/70. ESCORTED, AMB. TO EHS.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PVT,,,,,,"['Dizziness', 'Nausea', 'Sluggishness']",1,PFIZER\BIONTECH,IM 1049161,SC,51.0,F,"8 days later- itching at injection site, red and swollen 6"" across. Hot to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/22/2021,8.0,SEN,none,none,none,Tetnus,penicillin,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Tenderness']",1,MODERNA, 1049163,,25.0,F,"Tongue itchy, needing to clear throat. Gave benadryl in clinic without improvement. Was sent to ER. No tryptase done, discharged stable.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/20/2021,01/20/2021,0.0,PVT,,,,,,"['Throat clearing', 'Tongue pruritus']",2,PFIZER\BIONTECH,IM 1049164,OH,53.0,M,"I have had a slight headache since 2 days after my Vaccination. I have managed it with low dose ibuprofen. Today I had a worse feeling of pressure and checked my BP and it is sky high, both with an Automated Cuff and Manual Cuff. 160's-190's systolic and over 100 diastolic. I have no hx of Hypertension, nor have ever been prescribed meds for it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/27/2021,2.0,OTH,"multivitamin, Fish Oil.",,,,"Levaquin, Elavil","['Discomfort', 'Headache', 'Hypertension']",2,MODERNA,IM 1049165,GA,52.0,F,"24 hours after 2nd dose in her right arm, developed a rash, itching and splotches. symptoms resolved in 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,,,PVT,,,Asthma Sleep apnea Thyroid Nodule Diverticulitis GERD Open Angle Glaucoma,on 1/14/2021 she had a similar reaction to the 1st dose,Metronidazole Brimonidine Tartrate,"['Rash', 'Rash macular', 'Rash pruritic']",2,MODERNA,IM 1049166,,76.0,F,"Large raised, painful, red, itching area surrounding injection site lasting over 2 weeks.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/05/2021,02/13/2021,8.0,PVT,"Crestor, Lisinopril, Vitamin D, Calcium",,,,,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA, 1049167,PA,50.0,F,C/O feeling warm all over and developed a red lacy rash on trunk and extremities. Benadryl 25 mg tablet PO was given. BP taken.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,WRK,Albuterol,No,Asthma,Influenza 2018 - unknown,Sulfa,"['Feeling hot', 'Rash', 'Rash erythematous']",UNK,PFIZER\BIONTECH,IM 1049168,KY,43.0,M,"Red circle at injection site, redness, itching",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/22/2021,12.0,WRK,"Losartin, Gabapentin",,High blood pressure,,Sulfae,"['Injection site erythema', 'Injection site pruritus', 'Injection site reaction']",1,MODERNA,SYR 1049169,SD,51.0,M,painless swelling and redness to upper right arm 11 days after vaccination. Patient reports fatigue as well. Patient will use benadryl to help with redness. If itchy develops can use OTC hydrocortisone cream. If pain develops can take tylenol or motrin.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/11/2021,02/22/2021,11.0,PVT,"Advair Diskus 250 mcg-50 mcg/dose powder for inhalation INHALE ONE PUFF BY MOUTH TWICE A DAY amLODIPine 2.5 mg tablet TAKE ONE TABLET BY MOUTH ONCE DAILY divalproex ER 250 mg tablet,extended release 24 hr TAKE ONE TABLET BY MOUTH IN THE",,"affective psychosis F39 Unspecified mood [affective] disorder allergic rhinitis J30.9 Allergic rhinitis, unspecified anemia D64.9 Anemia, unspecified asthma J45.909 Unspecified asthma, uncomplicated J45.909 Unspecified asthma, uncomplicated hypertensive disorder I10 Essential (primary) hypertension hyponatremia E87.1 Hypo-osmolality and hyponatremia hypothyroidism E03.9 Hypothyroidism, unspecified impacted cerumen H61.23 Impacted cerumen, bilateral knee pain (Right) M25.569 Pain in unspecified knee tobacco user Z72.0 Tobacco use varicose veins of lower extremity",,none,"['Fatigue', 'Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 1049170,,46.0,F,left arm cellulitis 9 days post vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/18/2021,01/26/2021,8.0,UNK,,,,,,['Cellulitis'],1,MODERNA,IM 1049171,AZ,74.0,M,"Pain extending up into shoulder joint, down the bicep and back into the left scapula two days after the injection, with limited range of movement. Pain extended down into the left hip 4 days after the injection. Arthritis strength acetaminophen provides limited relief of should and scapula pain for about 5-6 hours. The hip pain resolved after 3 days. The shoulder and scapula pain continues.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/01/2021,02/03/2021,2.0,OTH,75 mg. aspirin,None,None,,None,"['Arthralgia', 'Injected limb mobility decreased', 'Injection site pain', 'Joint range of motion decreased', 'Pain in extremity']",1,MODERNA,SYR 1049172,FL,68.0,F,"Chills, muscle aches, headache, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/04/2021,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia']",2,MODERNA, 1049173,TX,57.0,M,"Low fever, Muscle Aches, Chills, BAD Headache, Swollen Lymph Nodes",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,OTH,"Lovastatin and Lecothyroxine Mens Multi-Vitamin, Dietary Supplement the includes Calcium, Magnesium, Zinc and Vitamin D3",None Last illness was COVID in October2020 compounded by double pneumonia... Recovered,Obesity,,None,"['Chills', 'Headache', 'Lymphadenopathy', 'Myalgia', 'Pyrexia']",UNK,MODERNA,IM 1049174,OH,78.0,F,"the night of vaccination, patient experienced severe itching in hands, feet and neck. she stated that she almost went to the er, however symptoms resolved in a matter of hours. patient was referred to allergist by primary care physician before she could receive second dose",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PHM,,,,,,['Pruritus'],1,MODERNA,IM 1049175,KS,38.0,F,"Passed out once over the weekend (2/20/2021-2/21/2021). Feels like she has a racing heart - started over the weekend and has persisted. I gave the pt instructions to see her PCP for evaluation. Pt stated she did have N/V, headache, low grade fever, body aches, and chills over the weekend as well but those symptoms have gone away.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/20/2021,1.0,PUB,,,,,,"['Chills', 'Headache', 'Loss of consciousness', 'Nausea', 'Pain', 'Palpitations', 'Pyrexia', 'Vomiting']",2,MODERNA,IM 1049176,PA,66.0,F,Patient called. She was seen on 2/16 for her second COVV. On 2/19 she started getting an itchy red area that was warm to touch it was around 6 inches long not at the injection site but below and extended to the elbow. She treated the area with cortisone cream and cool compresses and it is almost cleared up.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/19/2021,3.0,PVT,,,"Obesity, DM, hypertension",,Penicillins actos aspirin ceclor dexamethasone hydrochlorthiazide janumet jentadueto liraglutide victoza,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",2,MODERNA,IM 1049178,MI,61.0,F,"Severe dizziness, severe headaches, chills, muscle aches, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,PVT,Ralaxofene; Amlodopine; Vit D; Tylenol; Amovig,Hypertension; Constipation; Migraines,Hypertension; Constipation; Migraines,,Lactose; Black Cohosh; Stantins; Bentyl; Linzess,"['Chills', 'Dizziness', 'Headache', 'Malaise', 'Myalgia']",2,PFIZER\BIONTECH,IM 1049179,MT,45.0,F,"Patient started getting redness across her chest noticed by a registered nurse after receiving her first dose of the Moderna vaccine. 25mg of diphenhydramine was given with a glass of water and she was monitored for an additional 15 min., total observation time was 30min. The patient appeared to get a rash that continued to grow across her chest while under observation. She also complained of dizziness rating it a 3/10 severity, states ""there is no spinning"". The patient denied having a tight chest, difficulty swallowing, difficulty breathing, and sensation of swelling in her throat. She was instructed to seek medical attention if she started feeling any of the above mentioned symptoms. RN was informed and briefly spoke to the patient. She decided to stay a while longer and her care was transferred to Respiratory Therapist. She was instructed to consult with her PCP regarding the second dose of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,PVT,Unknown,unknown,unknown,,amoxicillin-hives,"['Dizziness', 'Erythema', 'Rash']",1,MODERNA,IM 1049180,OK,29.0,F,"Approx 5 minutes after receiving the vaccine, client started c/o feeling hot, sweaty, Left side of tongue numb and she had pressure on the left side of her head, her BP dropped and she felt weak. No medications given. She felt better after 10 minutes. She called her doctor and he gave her an epi pen and told her not to take the 2nd dose of Pfizer. She says she felt dizzy and weak for 3 weeks afterwards, but fine now.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,OTH,"coumadin, zyrtec",none,blood clotting disorder,,"Heparin, Luvenox, peroxide, Erythromycin","['Asthenia', 'Blood pressure decreased', 'Dizziness', 'Feeling hot', 'Head discomfort', 'Hyperhidrosis', 'Hypoaesthesia oral', 'Immediate post-injection reaction']",1,PFIZER\BIONTECH,IM 1049181,CO,70.0,M,I was having shortness of breath and my heart was beating way too fast and I started to monitor it with my blood pressure cuff and I noticed my heart rate was too fast. So I drove to the emergency room and they admitted me immediately. Diagnosed with Afib,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/20/2021,02/20/2021,0.0,OTH,lisinopril amlodepine vitamin D3,No,High blood pressure,,penicillin,"['Atrial fibrillation', 'Dyspnoea', 'Full blood count', 'Heart rate increased']",2,PFIZER\BIONTECH,SYR 1049183,,33.0,F,left arm cellulitis 1 week post vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/16/2021,02/23/2021,7.0,PVT,,,,,,['Cellulitis'],1,MODERNA,IM 1049184,TN,80.0,M,Pain and irritation in lymp node. pain still ongoing to this date.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,OTH,"Metformin, Glimepride, Jardiance, Carvedilol, Aspirin, Cilostazol, Atorvastatin, Lisinopril, meloxicam",none,"diabetes , high blood pressure, heart disease.",,none known,['Lymph node pain'],2,PFIZER\BIONTECH,IM 1049185,,49.0,F,Tremors in arm afterward,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/20/2021,01/20/2021,0.0,PVT,,,,,,['Tremor'],2,PFIZER\BIONTECH,IM 1049186,FL,80.0,F,"Red skin, hot, hard, swollen area around injection site. Swelling increased for 24 hours. Applied ice to affected area. At the time of this form the site is less swollen, no longer hot, and less red.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/21/2021,2.0,PHM,"levothyroxine 50mg 1PO QD, simvistatin 10mg 1 PO QD, famotidine 20 mg 1 PO PRN heartburn, vitamin C 1000 mg 1 PO QD, Centrum Silver 1 PO QD, Calcium 1200 mg 1 PO QD, Vitamin D-3 25 mg 1 PO QD, Vitamin K 2600 mcg 1 PO QD, Biotin 10,000mcg 1",migraine headaches on several days in the month prior to the vaccine,"migraine headaches, Hypothyroid, and slightly elevated cholesterol",,"Penicillin, Sulfa, Levaquin, Tetracycline","['Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site warmth']",2,MODERNA,IM 1049187,AL,66.0,F,"Approximately 1 week after injection, some redness and heat started around injection site. This has gone on for 2 weeks with less heat and splotchy red around site and down arm about 4-5- inches. Pain about 3 times a day --just for a second at the injection site, Today on the day before next injection....redness has almost disappeared.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,02/06/2021,10.0,PVT,atenolol losarten,none,hypertension,,none known,"['Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Rash macular']",1,MODERNA,SYR 1049189,AZ,67.0,M,"Started with numb feeling in my mouth, and that night my left eye wouldn't blink went to the ER and gave me Acyclovir and gave me prednisone 10 mg, Still cant blink my left eye.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/17/2021,6.0,UNK,"bare Apsirin , amlodipine, fluvistatin 40 mg,",No,No,,allergy Shots,"['Corneal reflex decreased', 'Hypoaesthesia oral']",1,PFIZER\BIONTECH,IM 1049190,CA,35.0,F,"30th, I woke up with tired, sore throat, headache - continued to January 2 and I had gotten worse with a severe cough; fever; body aches and I called employee health line and they had me get a test for COVID and it was positive result on January 3. I did not have any treatment. I had most of the symptoms for two weeks and cough lasted for a month. I was recovered from the symptoms before getting second dose of vaccine which was January 19th.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,Prilosec,no,no,,penicillin; vancomycin,"['Cough', 'Fatigue', 'Headache', 'Myalgia', 'Oropharyngeal pain', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,SYR 1049191,TX,56.0,F,"After patient received vaccine she had a rash and raised area around the injection site on 1/28/2021. Patient continued to have this and then on 2/17/2021 patient went to the ER with stroke like symptoms ie facial dropping , left sided weakness and slurred speech",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,PVT,"Clonidine HCL 0.1 mg tab, Vitamin D2 1,250 mg, levothyroxine 88 mcg, lovastatin 20 mg , proair HFA 90 mcg, Robaxin 750 mg","HTN, hypothyroid, uvular hypertrophy, depression, anxiety, obesity","HTN, hypothyroid",,mango flavoring,"['Dysarthria', 'Facial paralysis', 'Hemiparesis', 'Injection site rash', 'Injection site swelling']",1,MODERNA,IM 1049192,,55.0,F,left arm cellulitis 10 days post vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/22/2021,10.0,PVT,,,,,,['Cellulitis'],1,MODERNA,IM 1049193,,19.0,F,Lightheaded and headache,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/20/2021,01/20/2021,0.0,PVT,,,,,,"['Dizziness', 'Headache']",2,PFIZER\BIONTECH,IM 1049194,MI,34.0,F,"Itchy, red, swollen injection site, presenting one week after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/18/2021,7.0,MIL,"Levothyroxine, Nuvaring",None,Hashimoto's thyroiditis,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 1049195,LA,69.0,F,"During the next 60 hours I had the following reactions, though not all at the same time: 02/19/21: 10:00PM Nausea and extreme headache, 11:00 PM - 2 hours of uncontrollable shivering and headache 2/20/21: 2:AM Extreme headache (like Migraine), Nausea, Body aching for the remainder of the night. Tried Advil, then tylenol - didn't tough headache. 7:00AM - Headache, Body Aches, Fatigue, chills, mild diarrhea and dehydration throughout the day. Slept, finally that night. Advil helped the head and body aches finally. 2/21/21 - Left with body fatigue, mild diarrhea, dehydration. Night sweats for most of that night. 2/22/21 - energy back, mild diarrhea left. 2/23/21 - good, except left with mild diarrhea Leary of taking anything for the diarrhea, as I tend to block up. Through this whole ordeal, I consumed tons of water, almost drinking nonstop due to the thirst.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PHM,"levothyroxine 75mcg, pravastatin sodium 40 mg, zyrtec, nexium, acidophilus, centrum silver, viactiv calcium +D.",None,None,,None,"['Chills', 'Dehydration', 'Diarrhoea', 'Fatigue', 'Headache', 'Migraine', 'Nausea', 'Night sweats', 'Pain', 'Thirst']",2,MODERNA, 1049196,MN,85.0,F,"Resident developed a 100.2 F temperature and shortness of breath. Fever noted at 7:45 pm, Oxygen level was not above 88%, On-call RN was notified at 7:45 pm. RN advised staff to recheck vitals at 9:30 pm and to continue to monitor resident. Family was notified at 7:45 pm also. At 9:30 pm, check of vitals was done. Temperature was 102.5F, SpO2 was 93%, BP 107/63, pulse 102. At 9:50 pm, Family member requested that resident be sent to Emergency Room. EMS was notified, patient transported to Hospital ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,SEN,"Centrum, Vitamin D3, Remeron, Diclofenac Sodium, refresh tears, acetaminophen, Free and clear shampoo, Tacrolimus, Aquaphor lip repair, Desitin, Gabapentin, Senna, Sucralfate, Vanicream, Desonide, Loratidine, Miralax, Oxygen 2L, salt water","Waldonstrom Macroglobulinemia, Kidney Failure, Chronic Kidney disease, Dysphagia, Primary Hypertension, Paroxysmal atrial fibrillation, chronic heart failure, chronic kidney failure, Monoclonagammopathy, major depressive disorder, hypercalcemia,","Waldonstrom Macroglobulinemia, Kidney Failure, Chronic Kidney disease, Dysphagia, Primary Hypertension, Paroxysmal atrial fibrillation, chronic heart failure, chronic kidney failure, Monoclonagammopathy, major depressive disorder, hypercalcemia,",,Azithromycin,"['Body temperature increased', 'Dyspnoea', 'Pyrexia']",2,MODERNA,IM 1049197,FL,75.0,F,"generalize aching, chills with no fever, pain at the site of injection, headache, lasting for one day. Tylenol helps with the symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/20/2021,19.0,OTH,None,mild hypertension,none,,none,"['Chills', 'Headache', 'Injection site pain', 'Pain']",2,PFIZER\BIONTECH,SC 1049198,PA,46.0,F,"C/o right am numbness from injection site down back of arm. Full ROM of R. arm. Felt dizzy, slight redness below injection site. BP taken was elevated, sent to ED for additional monitoring",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/26/2021,0.0,WRK,,,,,,"['Blood pressure increased', 'Dizziness', 'Injection site erythema', 'Injection site hypoaesthesia']",UNK,PFIZER\BIONTECH,IM 1049199,IA,17.0,M,,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,PVT,,,,,,['Unevaluable event'],1,MODERNA,IM 1049200,CA,65.0,F,Patient returns to vaccination clinic approx 30 mins after observation period complaining of facial swelling and tongue tingling.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PVT,none,none,ALLERGIC RHINITIS ATHEROSCLEROSIS OF AORTA � BILAT CARPAL TUNNEL SYNDROME � DERMATOFIBROMA DYSLIPIDEMIA GERD (GASTROESOPHAGEAL REFLUX DISEASE) � ROUTINE ADULT HEALTH CHECK UP EXAM � HX OF COLONOSCOPY � LEFT ROTATOR CUFF TEAR � UTERINE FIBROIDS � LIPOMA � OSTEOARTHRITIS OF RIGHT ACROMIOCLAVICULAR JOINT � PERIPHERAL NEUROPATHY � PREDIABETES � RIGHT MASTODYNIA � RIGHT NIPPLE INVERSION � RIGHT ROTATOR CUFF TEAR � TELANGIECTASIA � WOLFF PARKINSON WHITE SYNDROME,chest heaviness and rapid HR with first Covid vaccine,none,"['Paraesthesia oral', 'Swelling face']",2,MODERNA,IM 1049201,,32.0,F,Suboptimal dose given (leaked out),Not Reported,,Not Reported,Not Reported,,Not Reported,,01/19/2021,01/19/2021,0.0,PVT,,,,,,"['Product leakage', 'Underdose']",2,PFIZER\BIONTECH,IM 1049202,NC,76.0,F,"light headedness, nausea, headache, fever 100, chills, extreme fatigue lasted 12 hours at least recovered after 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,SEN,Losartin 2.5 Ibupropen 400 m twice a day,none,slightly high bp medicine controlled,,none,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia']",UNK,MODERNA,SYR 1049204,IL,61.0,F,"FEVER, FATIGUE, AND HEADACHE",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/16/2021,02/17/2021,1.0,OTH,,,,,,"['Fatigue', 'Headache', 'Pyrexia']",1,MODERNA,IM 1049205,NC,79.0,F,"She woke up on the morning of 2/14/21, was not feeling real good, but noticed a tightness in her mouth. Her cheeks were swollen, she felt that maybe her tongue was as well. She got the liquid Benadryl and let it stay there and it helps that feeling. She had taken the Zyrtec and Singulair the night before. She did the inhaler puff in the morning, the feeling did not go away. She then took the Ventolin and it seemed to calm down. The symptoms then went away and didn't come back, and thought that she was ok. She felt bad for about a week and a half like she wanted to sleep all the time, but did what she had to do. She is fine now.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/14/2021,1.0,PHM,"Sertraline, Disopyramide, Montelukast, Zyrtec, Verapamil, Melatonin, vitamin D, Iron, Furosemide, Pantoprazole, Eliquis, stool softener, Flovent, allopurinol, B12, Vitamin C.",None.,"Asthma, COPD, Hypertrophic obstructive cardiomyopathy, has pacemaker, has two leaky valves, Afib.",Flu shot had diarrhea and vomiting,"Pinesol, codeine derivatives, penicillin, Sulfa, beta-blockers, Tramadol, Compazine, Demerol, bananas, contrast dye, dust, iodine, latex, molds, shellfish, strawberries, avocados, mangos (anything that comes from a rubber tree). She went into shock 4 times due to shellfish, avocados, contrast dye and latex (latex being the worst). Cats and dogs.","['Hypersomnia', 'Malaise', 'Mouth swelling', 'Swelling face', 'Swollen tongue']",1,MODERNA,IM 1049206,,44.0,F,Patient reported bilateral numbness in fingers and feet with dry mouth. Symptoms lasted greater than 15 minutes.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,UNK,,,,,,"['Dry mouth', 'Hypoaesthesia']",2,MODERNA,IM 1049207,GA,75.0,F,Body and lip itching after 2nd dose of vaccine- required medication intervention.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,PVT,MVT Vitamin D3 Vitamin B-12 Lipitor,None,Hyperlipidemia Aortic Estasia Sleep Apnea Obesity,,Diphenhydramine Metronidazole PCN Class Milk,"['Lip pruritus', 'Pruritus']",2,PFIZER\BIONTECH,IM 1049208,OH,31.0,F,"1. hives/ break out across shoulders delayed reaction 2. Burning sensation in spine (lasting 1 week, now occasionally appears)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/13/2021,2.0,SCH,ibuprofen taken after vaccination,,,,erythromycin (hives),"['Burning sensation', 'Urticaria']",1,MODERNA,IM 1049209,OH,70.0,F,"Hives, Diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,UNK,"ASA, Calcium, Vit. D, Fosamax, Linzess, Oxybutynin, Omeprazole, Celecoxib, Bupropion, Cymbalta, Ambien, Simvastatin, Norco.",None.,"Hyperlipidemia, IBS, Depression, Hypothyroidism, DDD, Osteoporosis, Myalgia, Glaucoma, OA, GERD",,"Homatropine, Codeine, Diazepam, Levofloxacin, Penicillin, Mobic, Lyrica","['Diarrhoea', 'Urticaria']",1,PFIZER\BIONTECH,IM 1049210,OH,70.0,F,"Patient came to our drive thru Covid 19 vaccination clinic to receive her second dose of Moderna. Pfizer vaccine was given inadvertently to patient. Patient denies any reactions. Dr. phoned the patient the next day and patient is fine, still no reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PUB,,,,,,"['Interchange of vaccine products', 'No adverse event']",2,PFIZER\BIONTECH,IM 1049211,,52.0,M,"A few minutes after receiving the vaccine, patient reported 1/10 chest pressure to left chest, to left shoulder, improving after 15 minutes. No nausea, light headedness. Non-smoker, no HTN or DM.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/20/2021,0.0,UNK,,,,,,"['Chest discomfort', 'Immediate post-injection reaction']",2,PFIZER\BIONTECH,IM 1049212,WI,43.0,F,"30 minutes after: nausea, dizziness, fatigue; later in the day and for days after: pain and swelling and tenderness at injection site, muscle tenstion, fatigue; next day and multiple days after: muscle and joint aches, fatigue, some headaches and chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,PUB,"1 venlafaxine 150 mg extended release capsule, 2 gabapentin 300 mg capsules, Coenzyme Q10 , ascorbic acid (vitamin C) 500 mg tablet, Magnesium Carbonate Powder (Calm brand citrate), magnesium oxide 250 mg tablet, cholecalciferol (vitamin D",no,"migraines, Fibromyalgia, Raynaud's disease",,"penicillin, amoxicillin","['Arthralgia', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Muscle tightness', 'Myalgia', 'Nausea']",UNK,MODERNA, 1049213,FL,52.0,F,"Rash to the top of bilateral thighs, waist and breast bilaterallys, Palms of bilateral hands bright red and tongue felt a little thich",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,02/01/2021,12.0,PVT,"Metformin, Rybelsus, HCTZ, Atenolol, ASA, Crestor, Zetia, Protonix, Levothyroxine, Tylenol, Motrin, Vit D, Multi Vitamin, Biotin","Viral Illness - Headache, sore throat late december","Hypertension, Hyperlipidemia, Hypothyroid, Diabetic, Arthritis, Fatty Liver",,"Reglan, Lipitor & seasonal allergies","['Epinephrine', 'Erythema', 'Rash', 'Tongue disorder']",1,PFIZER\BIONTECH,IM 1049214,KY,37.0,F,"9 days after vaccine, I noticed a red rash under my left arm. Day 10, I experienced extreme tenderness above the rash along with what feels like a swollen lymph node. Area felt bruised and could not be touched without pain for 3 days following. Day 11, I felt a pulling sensation when lifting my arm overhead and noticed when lifting my arm, it looked like a tendon was protruding through the skin(under my arm), and the tendon is easily palpable when touching the arm lightly Day 20, my arm feels extremely heavy, I still have pain under my arm, there is still tightness, the tendon is still protruding, and Im having slight numbness in my left hand.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/12/2021,9.0,PUB,"Sprintec, Turmeric tincture, Vitamins for runners",none,none,,none,"['Hypoaesthesia', 'Injection site erythema', 'Injection site joint movement impairment', 'Injection site pain', 'Injection site rash', 'Limb discomfort', 'Lymphadenopathy', 'Skin tightness', 'Tendon dislocation']",1,MODERNA,SYR 1049215,,36.0,F,Passed out twice. Nausea and Headache.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/13/2021,1.0,UNK,,,,,,"['Headache', 'Loss of consciousness', 'Nausea']",2,MODERNA,SYR 1049216,IN,71.0,M,"Extreme muscle pain in buttocks and thighs and biceps began 2 days after injection. Pain and muscle weakening increased and moved on to include total leg, wrists, forearms and hands. Could not sit or rise from seated position or bend with out using cane. Could not grip blankets to cover myself in bed or put on socks by myself. This lasted for 2 weeks. Now have recovered to 95% pain free",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/04/2021,2.0,PUB,"Amlodipine, Aspirin (81), Atorvastatin, Celecoxib, Finasteride, Fish oil, Losartan hydrochlorothiazide, Metformin,Metoprolol succinate, Tamsulosin",Hip tendonitis,"Diabetes, hypertension, cardio vascular disease",,None,"['Arthralgia', 'Dysstasia', 'Grip strength decreased', 'Muscular weakness', 'Myalgia', 'Pain in extremity', 'Polymyalgia rheumatica', 'Walking aid user']",1,MODERNA,SYR 1049217,NE,81.0,M,"Got shot on 1-11-21 and on 1-13-21 am was totally unresponsive , oxygen level low and passed away on 1-14-21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/13/2021,2.0,SEN,hydrocodone prednisone gabapentin clonazepam methotrexate,congestive heart failure arthritis,heart disease arthritis,,none,"['Death', 'Oxygen saturation decreased', 'Unresponsive to stimuli']",UNK,MODERNA,SYR 1049218,,52.0,M,"Patient reported throat irritation, which started a few minutes after receiving vaccine. Symptoms improved at 15 minutes. Had similar reaction with flu vaccine. 14:00 Patient called. Reported he took diphenhydramine. Throat irritation decreased. Reports headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,UNK,,,,,,"['Headache', 'Throat irritation']",1,MODERNA,IM 1049219,CA,35.0,M,"About 8 pm that night, I felt my chest going really fast - my heart rate was high. I called the nurse hotline. They asked me if I had pain and I said no. Just a high heart rate. WAs told to monitor it. Next day, I had chest pain and tightness in chest and fast heartrate. I went to ER. Gave me IV; fluids and steroids. They sent me home with steroids for five days. About three or four days after steroids were done, it resolved the symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,PVT,Prilosec,COVID - after of Pfizer Vaccine Dose 1,no,Pfizer Dose 1 - adverse events - got COVID after the vaccine - 12/29/2020,penicillin; vancomycin,"['Chest X-ray', 'Chest discomfort', 'Chest pain', 'Electrocardiogram', 'Heart rate increased']",2,PFIZER\BIONTECH,SYR 1049220,IN,53.0,F,10cm x 5cm large circular erythematous itchy rash. which resolved with Benadryl but patient presented into office with right neck 1cm lymph node which appeared when the rash did.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/29/2021,2.0,OTH,"synthroid, albuterol",none,"hypothyroidism, asthma",,KNDA,"['Full blood count', 'Lymphadenopathy', 'Metabolic function test', 'Rash erythematous', 'Rash pruritic', 'SARS-CoV-2 antibody test']",1,MODERNA,IM 1049221,WI,70.0,M,"Pt presented to vaccine clinic to receive second dose of COVID 19 Moderna vaccine. Pt did not have his COVID vaccine administration card. When Pt presented to this writer to receive vaccine, he had already been checked in and verified and provided his informed consent form that was completed and signed. Pt reported that he had no adverse events from his first dose of Moderna. This writer verified Pt's name, DOB, and reason for visit to vaccine clinic. Pt was informed of potential adverse events and offered appropriate education. Vaccine administered and Pt observed for 15 minutes post injection. No adverse event noted and Pt left vaccine clinic ambulatory. Upon return to the clinic, Pt's second dose of Moderna vaccine was documented. This writer became aware that the Pt had received his second dose of the Moderna vaccine one week too early when verifying the schedule for an upcoming vaccine clinic. A telephone was made to the Pt to inform them of the event that occured and explain that Pt would not need to receive an additional dose, however, there was no answer and there was no voicemail available to leave a message.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,OTH,"Buprorpion, Clopidogrel, , Ferrous Sulfate, Flomax, Hydrochlorothiazide, Lipitor, Lisinopril, Paxil, Potassium Chloride, Pro Air Inhaler, Protonix, Spiriva, Ventolin Inhaler, Breo Ellipta, Zyrtec",None,"COPD, Cardiac issues",,None,"['Inappropriate schedule of product administration', 'No adverse event']",2,MODERNA,IM 1049222,IL,45.0,F,FATIGUE,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/15/2021,02/17/2021,2.0,OTH,,,,,,['Fatigue'],1,MODERNA,IM 1049223,PR,52.0,F,"Strong headache, in the left arm and all over the body. Nauseas Chills Dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PUB,NO,Hypoglycemia Hives Arthritis,NO,"Headache, in the arm and in the body.",NO,"['Chills', 'Dizziness', 'Headache', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,SYR 1049224,AZ,74.0,F,COVID Arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/19/2021,18.0,PHM,"Amiloride, Indapamide,, Vitamin D, Levothyroxine, Escitalopram, Potassium",None,"Hypothyroidism, osteopenia",,Erythromycin,['Injection site reaction'],1,MODERNA,IM 1049225,FL,80.0,F,Redness and swelling from shoulder to elbow. skin hot.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/17/2021,6.0,UNK,"Bystolic, Potassium Chloride,","Controlled high blood pressure,",,,"Penicillin, Sulfa Drugs, Iodine, Aspirin, Wool, Benedryl (very severe), Latex (mild),","['Erythema', 'Skin warm', 'Swelling']",1,MODERNA,IM 1049226,MN,64.0,F,"Moderna Covid vaccine. Covid arm stron g reactions. 2/11- 2/13 Swelling, bruising, redness, extreme itchiness, pain to to tightness. Treated with Benadryl, hydrocortisone crepe, ibuprofen, rest. Three day duration. Another brief reaction 2/17. Same symptoms milder and shorter duration of i.5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/11/2021,7.0,OTH,None,None,None,,Penicillins products Poison Ivy Poison Oak,"['Contusion', 'Erythema', 'Pain', 'Pruritus', 'Skin tightness', 'Swelling']",UNK,MODERNA,IM 1049227,AZ,66.0,F,Dyspnea at 3different times within 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,OTH,Synthesis Prevacid Immutable Prednisone Oxycodone,Autoimmune hepatitis,Chronic psin,,Gabipenton,"['Dyspnoea', 'Oxygen saturation', 'Oxygen saturation decreased']",2,PFIZER\BIONTECH,SYR 1049228,NC,49.0,F,Fever Headache Body Aches Diarhea Swollen Lymphnodes Terrible Shoulder/Arm pain Attacked Lymphatic System,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PVT,Tylenol; Sertraline,None,None,,Sulfa; Shellfish,"['Arthralgia', 'Diarrhoea', 'Headache', 'Lymphadenopathy', 'Lymphatic disorder', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1049229,NC,47.0,F,Swelling underneath arm pit. doctor advised Tylenol and warm compress,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/21/2021,02/23/2021,2.0,MIL,"blood pressure, sinuses",,,,,['Oedema peripheral'],2,PFIZER\BIONTECH,SYR 1049230,PA,34.0,M,Chills that were worse than the first time for about 4 hrs. Mild headache next day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/06/2021,0.0,PVT,None,None,Volunteer Fire Fighter ?,,None,"['Chills', 'Headache']",2,MODERNA,SYR 1049231,NY,22.0,F,"Patient assessed via virtual visit on 2/21 Got 2nd dose of Moderna vaccine on 2/20. On way home was having tongue swelling. Sharp CP radiating to diaphragm and throat swelling since last night. +wheezing. Walking from bed to bathroom gets SOB SOB gradually worsened as time passed Dizziness since difficulty breathing paresthesia in hands diaphoresis - pt attributes to fever/chills she has been getting since having the vaccine Denies n/v, abdominal pain, syncope Dyspnea, oral swelling, CP began s/p Moderna vaccine 2 of 2 and gradually worsening Advised ER via ambulance. Pt prefers to wait for her dad to take her to the ER Counseled pt on risk of death due to airway cut off due to worsening sx: bronchial inflammation/throat swelling or decreased oxygen to heart/brain with dizziness (MI/stroke). Advised tools EMS would be able to administer life saving medications to support her in these emergent situations and quickly get pt to ER vs having her die in car with dad bearing guilt of losing daughter. Pt expresses understanding, will wait for her dad. Suggested pt have a code word to say so if things getting worse her dad pulls over to call 911. Pt agreeable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,"metoclopramide HCl, 10 mg rapid dissolve PO tid",Gastroenteritis,,,Penicillin - hives,"['Chest pain', 'Chills', 'Condition aggravated', 'Diaphragmalgia', 'Dizziness', 'Dyspnoea', 'Hyperhidrosis', 'Pain', 'Paraesthesia', 'Pharyngeal swelling', 'Pyrexia', 'Swollen tongue', 'Wheezing']",2,MODERNA,IM 1049232,CA,30.0,F,"Dizziness, nausea, headache, feeling on lip swelling and ""dripping"" feeling to back of throat",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PVT,,,joint pain,Moderna Covid-19 vaccine,,"['Dizziness', 'Headache', 'Lip swelling', 'Nausea', 'Upper-airway cough syndrome']",2,MODERNA,IM 1049233,FL,85.0,M,"My husband started having a reaction 12 hours later, he said he didn't feel good, he didn't want to move, cold and felt weak, and couldn't get out of his chair, he was unstable.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/23/2021,1.0,OTH,"Atorvastatin 10mg (PM), Amlodipine 2.5mg, Plavix 75mg, Donepezil HCL/Aricept 10mg, (AM) Memantine HCL 5mg(am&pm),",no,Dementia,Shingrix - a slight reaction,no,"['Asthenia', 'Feeling cold', 'Gait disturbance', 'Malaise', 'Mobility decreased']",2,MODERNA,IM 1049234,TN,38.0,F,"States a few minutes of receiving first Covid vaccine (Moderna) complaints of swelling, burning, and itching on L arm which progressed to left neck and ear. Went to see HCP immediately and received Benadryl and steroid shot. Feeling better day after receiving vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,PUB,Benadryl pill,,,"Trouble breathing with flu shot ""a few years ago""","Latex, flu vaccine","['Burning sensation', 'Ear discomfort', 'Peripheral swelling', 'Pruritus', 'Swelling']",1,MODERNA,IM 1049235,IL,73.0,F,"Rash, hives, warm to touch, itching, swelling, ache. Took antihistamine, applied hydrocortisone. Still red,etc. on 2/23/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/20/2021,8.0,UNK,No,No,No,,Yes. Sulfa,"['Pain', 'Pruritus', 'Rash', 'Skin warm', 'Swelling', 'Urticaria']",2,MODERNA,SC 1049237,AL,31.0,F,"Fatigue, Nausea, Vomiting, Chills, Body Aches, Very stiff arm from injection, extremely bad taste in my mouth as soon as I was given the shot",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,OTH,,,,,Gluten,"['Chills', 'Fatigue', 'Musculoskeletal stiffness', 'Nausea', 'Pain', 'Taste disorder', 'Vomiting']",UNK,MODERNA,SYR 1049238,MN,74.0,F,"Aches ,sore arm/slight fever/1 day...tired,sore arm.6 days loss of taste and smell 1 week. 2 weeks later rash on inner arms and legs...better but still have it on day day 18",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/14/2021,8.0,OTH,"Vit.d,magnesium,baby asperin",,High blood pressure,Polio booster at 17,Some dairy and eggs,"['Ageusia', 'Anosmia', 'Fatigue', 'Pain', 'Pain in extremity', 'Pyrexia', 'Rash']",UNK,MODERNA,SYR 1049239,MI,69.0,M,"Sudden nasal infection which I started to take Sudafed for. I also had weakness, fatigue, heavy diarrhea for two days and of course heavy nasal infection. It did not go to my chest however. After 4 days of sickness i now feel much better. I did not have a fever or nausea during my sickness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PHM,Losartan Asp. vitamin pills,No,No,,No,"['Asthenia', 'Diarrhoea', 'Fatigue', 'Illness', 'Sinusitis']",2,MODERNA,IM 1049240,CA,39.0,F,"2/2/2021- 1 day after vaccination, Pt. noted swollen upper lip (swelling greater than lower lip). Slight itching. 2/3/2021- patient noted blister on top lip open with blood and body aches started and lasted until 2/16. Pt. did mention during clinic that she does develop a similar reaction when she eats salmon- but does not have blisters on her lip. She has also never had a cold sore before.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/02/2021,1.0,PVT,"Levothyroxine po daily Zyrtec po daily Gapiscon (antacid) 800 mg ibuprofen daily from 2/2-2/16 Cymax - 2 shots, 1 time per month",Denies,Thalassemia minor Dermatographia Rheumatoid arthritis,,No allergies to medications Hives with salmon,"['Lip blister', 'Lip swelling', 'Myalgia', 'Pruritus', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 1049241,CA,68.0,F,"2/15/2021 diarrhea thru 2/20. Starting on 2/19/2021 Left side facial numbness NOT paralysis. HIGH BLOOD PRESSURE> 200/88 without intervention. Severe headache , nausea and vomiting, generally feeling very bad. No fever.",Not Reported,,Yes,Yes,3.0,Not Reported,N,02/13/2021,02/15/2021,2.0,PHM,"Fluoxetine, fenofibrate, clonodine, baby aspirin, spironolactone,vitamin d, magnesium, potassium,.",,High blood pressure,"Penicillin 18 mos. old, tetanus toxoid 8 yrs old, percodan 1978","Penicillin, Tetanus Toxoid, percodan,","['Angiogram', 'Computerised tomogram head normal', 'Diarrhoea', 'Echocardiogram', 'Feeling abnormal', 'Headache', 'Hypertension', 'Hypoaesthesia', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging neck', 'Nausea', 'Scan with contrast', 'Vomiting']",1,MODERNA,SYR 1049242,MA,34.0,M,"Patient received second dose of Pfizer vaccine at 5pm on 2/18/21 and experienced expected symptoms of fatigue, injection site pain and minor body aches. Patient began to experience difficulty breathing on the morning 2/20, at that time the patient attributed it to asthma. Patient reports that he has not had an acute asthmatic episode in 25 years and has not experienced any respiratory condion like this before. Shortness of breath, chest pain and dizziness increased in the day to follow. On Monday 2/22 at 8:30am patient was seen at family medical facility by Doctor presenting with a 02 SAT of 93%. Covid test was preformed and was negative. Dr prescribed a preventative inhaler and some prednisone and sent patient home. Patient continued to decompensate and at 6pm was seen by previously treating physician, presenting with 02 sat of 91% given a nebulizer and sent home. Patients condition worsened overnight and he was seen in the faility Urgent care at 9am on 2/23. Patient was given a repeat covid test, that was negative , flu test that was negative, and chest xrays that were clear.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/20/2021,2.0,PVT,rescue inhaler,none,controlled asthma,,nka,"['Asthma', 'Chest X-ray normal', 'Chest pain', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Influenza virus test negative', 'Injection site pain', 'Myalgia', 'Oxygen saturation decreased', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 1049243,MT,34.0,F,"Injection site pain, chills, swollen lymph nodes",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Chills', 'Injection site pain', 'Lymphadenopathy']",2,MODERNA,IM 1049244,IL,,U,.,Not Reported,,Not Reported,Not Reported,,Not Reported,,,,,OTH,,,,,,['Unevaluable event'],1,MODERNA,IM 1049245,GA,49.0,F,"small nodule, painful sweeling on shoulder blade area",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,02/01/2021,31.0,PVT,Albuterol HFA Meloxicam Zyrtec,None,Prediabetes,,None,"['Arthralgia', 'Nodule', 'Swelling']",2,PFIZER\BIONTECH,IM 1049246,NC,79.0,F,"On Feb 21, fever of 101 discomfort in arm, extreme tiredness. Difficulty sleeping. On February 22, fever of 99.1 , increased redness, heat, and swelling at site (about the size of my palm). Iced site for about an hour and took citirezine antihistamine. Feb 23, today AM temp 98.6, perhaps size of swelling has decreased. Still painful to raise arm there. Can do all household activities.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/21/2021,1.0,PUB,None,None,Above-mentioned allergies,,"Pollen, dander, mold","['Fatigue', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Insomnia', 'Limb discomfort', 'Pain', 'Pyrexia']",2,MODERNA,IM 1049247,CA,36.0,M,"Experienced Crohn's type symptoms subsequent to both vaccinations. Primary symptoms included blood in stool and constipation. No treatment was given after 1st vaccine and symptoms were starting to subside after 3 weeks just before 2nd dose. After second dose, symptoms immediately and started course of Prednisone 20mg/day as treatment tapering off over 3 weeks. Prednisone relieved symptoms within 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/20/2021,1.0,PUB,"Prilosec, Humira, Simvastatin",,Crohns disease,,Penicillin,"['Condition aggravated', 'Constipation', ""Crohn's disease"", 'Haematochezia']",2,PFIZER\BIONTECH,SYR 1049248,IA,17.0,M,,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,PVT,,,,,,['Unevaluable event'],1,MODERNA,IM 1049249,FL,68.0,F,Patient received vaccine around 6pm and had some swelling in her ankle around 9pm bilateral. States she thought the inside of her cheek was swollen but thinks it doesn't feel any different now than it did then and think she was just in her head about it. She forgot to take her BP meds that morning and took them the following day and swelling in her ankles went down within 24 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,PHM,"Losartan, Chlorthalidone, Metoprolol tartrate, Potassium Chloride, Famotidine, Pantoprazole, Aspirin 81mg, Atorvastatin, Montelukast, Certavite SR antioxidant, Albuterol HFA PRN, Metformin, Lyrica, Nitrostat PRN (hasn't used), Ondansetron,",Patient was severely sick 5 weeks prior to vaccination (covid test negative and antibody negative) and thinks it was food poisoning. Dropped 8 lbs and was vomiting. 2-3 weeks prior gained back 16 lbs after sickness resolved.,"Hypertension, Acid reflux, High cholesterol, allergies, diabetes,",,"Advair, Lisinopril, Norvasc","['Confusional state', 'Joint swelling']",1,MODERNA,IM 1049250,MD,28.0,F,Syncopal event 17 hours later,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PVT,desogestrel/ethinyl estradiol,None,No chronic issues,,Sulfa drugs,['Syncope'],UNK,PFIZER\BIONTECH,IM 1049251,CT,72.0,F,Pt received her first dose of the Moderna COVID19 vaccine Oxygen Sat 95% HR 102 BP 190/90 BP recheck 10 minutes later 158/78 HR 78 Pt reported feeling ?queasy? and unwell about 10 minutes after vaccination. Pt was evaluated by Prospect EMS paramedic. Pt reported being very afraid and nervous that the vaccine implanted a micro chip in her and she is scared she is going to start ?.? Pt signed refusal for transport to the hospital with Prospect EMS. Pt reported feeling better.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PUB,Unavailable for review in VAMS,None,Unavailable for review in VAMS,,Unavailable for review in VAMS,"['Fear', 'Malaise', 'Nausea', 'Nervousness']",1,MODERNA,IM 1049254,AZ,72.0,F,"Migraine evening of vaccine and day after. Nausea , vertigo and dizziness everyday since",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,PHM,"Prednisone, Levothyroxine, Metoprolol, Flecainide, Atorvastatin, Omemprazole, Linzess, CoQQ10",constipation,none,,Vancomyacin,"['Dizziness', 'Migraine', 'Nausea', 'Vertigo']",UNK,MODERNA,SYR 1049255,GA,40.0,F,"generalized muscle ache fatigue injection site swelling, errythema and pain Headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/14/2021,1.0,PVT,none,none,none,,none,"['Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Myalgia']",2,PFIZER\BIONTECH,IM 1049256,WI,68.0,M,"The day following the injection the client's left arm from the injection site to his elbow was red and very itchy. A few days later the redness traveled down to his forearm and a bumpy rash also appeared from the injection site to the forearm. The client reports that his arm is so itchy that he has not slept much since 01/28/2021. The client sought medical attention on 02/17/2021 and was put on a prednisone taper. The client indicates he feels the rash and itchiness is ""a little better"". The client's medical provider told him to RTC if symptoms were not improving. The client reports that he feels they are improving and he is not going to see his medical provider at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,PUB,Takes Vitamin K and Vitamin D daily,No,"Chronic high blood pressure and has had 3 heart surgeries where stints have been placed in 2009, 2011, and 2018",,Allergic to MRI contrast agents,"['Erythema', 'Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Rash papular', 'Sleep disorder']",1,MODERNA,IM 1049257,CA,42.0,F,Vaginal bleeding about an hour after first dose,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/10/2021,01/17/2021,7.0,PVT,pre natal vitamins,,,,,['Vaginal haemorrhage'],UNK,PFIZER\BIONTECH, 1049258,TX,71.0,M,Patient's family report that patient was in the hospital with Pneumonia due to COVID-19 virus,Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/12/2021,01/29/2021,17.0,PVT,,,,,,['COVID-19 pneumonia'],6,MODERNA,IM 1049259,FL,74.0,F,"vaccine administered on 2/13, reaction on 2/21. Site itching, redness, 2 swollen areas.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PHM,"osteo bi-flex triple strength, turmeric, daily vitamin, eye vitamin, and eye drops",,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA,IM 1049260,MA,46.0,F,"Headache, muscle aches, arm pain, fever - for 48h Headaches continued for 7 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,PUB,lexapro,,,,,"['Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 1049278,CO,,F,"Second shot at gap of 35 days; Left arm sore; Bodyache; This spontaneous report was received from consumer on 05-feb-2021, concerning a 75 year old female patient who was administered Moderna COVID-19 vaccine9( mRNA-1273). and she had experienced sore arm, body ache and Inappropriate schedule of vaccine administered. The patient's medical history was not provided. Concomitant medication also not provided. The patient received suspect product mRNA-1273 on 05/Jan/2021, prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:025L20A) intramuscularly on the left arm for prophylaxis of COVID-19 infection On 05 Jan 2021, the patient received her first shot in her left arm. She experienced a sore arm for 2 days and body ache for a couple of hours following the vaccination. On 25 Jan 2021, at surgical center she received steroid epidural injection in her back for pain, her Moderna Vaccine is scheduled 2 days after the steroid shot. But, she was able to reschedule her second dose 5 weeks from 1st shot that is on coming Tuesday 09Feb2021. Caller enquired having second shot at gap of 35 days is fine. Having a steroid injection prior to Moderna COVID Vaccine is safe and will it have any effect on the vaccine effectiveness. Action taken with the second dose of mRNA-1273 in response to the event was not reported; Reporter's Comments: This case concerns a 75-year-old female who had NS expected adverse events of Vaccination site pain and Myalgia occurring 1 day after the first dose of mRNA-1273. She had a NS unexpected event of Inappropriate schedule of vaccine administered without associated AEs after a delay in the second dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the adverse events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,01/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Inappropriate schedule of product administration', 'Myalgia', 'Vaccination site pain']",1,MODERNA,OT 1049279,NY,62.0,F,"when vaccine was being administered, the needle disconnected from the syringe; caused some vaccine to end up on the patient's arm; incorrectly administered dose; A spontaneous report was received from a pharmacist (PharmD) concerning a 62-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced when vaccine was being administered, the needle disconnected from the syringe (device connection issue) that caused some vaccine to end up on the patient's arm (exposure via skin contact) and an incorrectly administered dose (underdose). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot number: 012M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. When the vaccine was being administered, the needle disconnected from the syringe. This caused some of the vaccine to end up on the patient's arm and an incorrectly administered dose. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The events, when vaccine was being administered, the needle disconnected from the syringe that caused some vaccine to end up on the patient's arm, and an incorrectly administered dose, were considered recovered/resolved on 28 Jan 2021.; Reporter's Comments: This report refers to a case of device connection issue, exposure via skin contact and underdose with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Device connection issue', 'Exposure via skin contact', 'Underdose']",1,MODERNA,OT 1049280,CA,,F,"got pain in the arm; fatigue; chills; Vaccinated from a prefilled syringe that surpassed 6 hours; A spontaneous report was received from a pharmacist who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pain in the arm, fatigue, chills following vaccination from a prefilled syringe that has surpassed six hours. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received her first of two planned doses of mRNA-1273 (BATCH # 041L20A) on 02 Feb 2021 intramuscularly in the left arm for prophylaxis against COVID-19 infection. Pharmacist received first dose on 02 Feb 2020 to left non dominant arm. Pharmacist stated I got pain in the arm, fatigue, chills after the dose. Pharmacist stated they were conducting clinics at hospital site, extra unused doses in syringe were brought back to pharmacy, and being used for administering other patients for last two weeks that were in syringes for over six hours. HCP (healthcare professional) wanted to know how long it can be stable in syringe, as she knew punctured vials needed to be discarded after six hours but what about dose in syringe. Also, she asked if they could transport in syringe to different sites and conditions to maintain for transport when they are in syringes. Approximately thirty patients were administered from those syringes. HCP stated that it was first dose for all patients. HCP does not know any information on those patients except, was one of the recipients of dose of vaccine from that syringe. Consented for safety follow-up with reporter. Pregnancy status unknown, age not provided. No further information was reported. No treatment information was provided. Action taken with RNA-1273 in response to the event was unknown. The outcome of the events was unknown. The reporter did not provide an assessment for the events, got pain in the arm, fatigue, chills and vaccinated from a prefilled syringe that surpassed six hours.; Reporter's Comments: This report refers to a case of ""Expired Product Administration"" of mRNA-1273, lot # # 041L20A with associated adverse events of limb discomfort, fatigue and chills. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2020,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Chills', 'Expired product administered', 'Fatigue', 'Vaccination site pain']",1,MODERNA,OT 1049281,TX,69.0,F,"arm was slight red; lump appeared at injection site; administer went past muscle to the bone; when administrator removed needle, fluid rolled down arm; unsure if received any vaccine; A spontaneous report was received from a consumer, who was also a 69-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced administrator went past muscle to the bone (product administration error), when administrator removed needle, fluid rolled down arm (exposure via skin contact), unsure if received any vaccine (underdose), arm was slight red (erythema), and lump appeared at injection site (injection site mass). The patient's medical history was not provided. Concomitant medications included levothyroxine sodium and lovastatin. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) for prophylaxis of COVID-19 infection. On 05 Jan 2021, the same day as the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: 013M20A) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 05 Feb 2021, the vaccine administrator went past the muscle to the bone. When the administrator removed the needle, fluid rolled down the patient's arm. The patient was unsure of she received any vaccine. The patient also reported her arm was slight red and a lump appeared at the injection site. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable. The outcome of the events, administrator went past muscle to the bone; when administrator removed needle, fluid rolled down arm; and unsure if received any vaccine, was considered recovered/resolved on 05 Feb 2021. The outcome of the events, arm was slight red and lump appeared at injection site, was unknown.; Reporter's Comments: This report refers to a case of product administration error, exposure via skin contact, underdose, injection site erythema, and injection site mass for mRNA-1273, unknown lot #, with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,SYNTHROID; LOVASTATIN,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Erythema', 'Exposure via skin contact', 'Injection site swelling', 'Product administration error', 'Underdose']",1,MODERNA,OT 1049282,PA,44.0,M,"Couldn't feel arm; Couldn't feel arm and had no range in motion; Pain in upper shoulder area by his neck; Thinks the administration was done incorrectly; Aching in legs as if he was getting sick; Aching in legs as if he was getting sick; Pain in upper shoulder area by his neck; A spontaneous report was received from a nurse concerning her son, who was a 44-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced couldn't feel arm and had no range in motion (hypoaesthesia, joint range of motion decreased), pain in upper shoulder area by the neck (arthralgia, neck pain), thinks administration was done incorrectly (product administration error), and aching in legs as if was getting sick (arthralgia, malaise). The patient's medical history was not provided. Concomitant medication included escitalopram. On 04 Feb 2021, on the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 030L20A) in the left arm for prophylaxis of COVID-19 infection. On 04 Feb 2021, a couple of hours after the vaccination, the patient couldn't feel his arm and he had no range in motion. He also had pain in his upper shoulder area by his neck. The reporter thought the administration was done incorrectly but she ""wasn't there to conform 100%."" At night on 04 Feb 2021 and 05 Feb 2021, the patient had aching in his legs ""as if he was getting sick."" Treatment for the events included ibuprofen which helped, and the patient was feeling better at the time of this report. Action taken with mRNA-1273 in response to the events was not reported. The events, couldn't feel arm and had no range in motion, pain in upper shoulder area by the neck, and aching in legs as if was getting sick, were considered recovering/resolving at the time of this report. The event, thinks administration was done incorrectly, was considered recovered/resolved on 04 Feb 2021.; Reporter's Comments: This case concerns a 44-year-old male who experienced NS unexpected events of hypoaesthesia, joint range of motion decreased, arthralgia, neck pain, product administration error, malaise, and NS expected arthralgia. The events occurred 1 day after the first dose of mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-012275: US-MODERNATX, INC.-MOD-2021-012263:",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,UNK,ESCITALOPRAM,No adverse event (No reported medical history),,,,"['Arthralgia', 'Hypoaesthesia', 'Joint range of motion decreased', 'Malaise', 'Neck pain', 'Pain in extremity', 'Product administration error']",1,MODERNA, 1049283,CA,41.0,F,"Hypertrophic Cardiomyopathy; Chest Pain; Chest Pressure; Numbness in Left Arm; Back Pain; A spontaneous report was received from a nurse concerning herself, a 41-years-old, female patient who experienced hypertrophic cardiomyopathy, chest pain, chest pressure, numbness in left arm, and back pain. The patient's medical history was not provided. concomitant medications included metoprolol, omeprazole and acetylsalicylic acid. On 21 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 [Lot number 0412L0A] intramuscularly in the for prophylaxis of COVID-19 infection. On 25 Jan 2021, four days after the vaccine administration, the patient started experiencing chest pain, chest pressure, numbness in left arm, back pain and hypertrophic cardiomyopathy and was hospitalized in emergency room for 48 hours from 25 Jan 2021 to 26 Jan 2021. The event hypertrophic cardiomyopathy was also considered to be medically significant. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not provided. The outcome of the events chest pain, chest pressure, numbness in left arm, back pain and hypertrophic cardiomyopathy were considered unknown at the time of this report.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/21/2021,01/25/2021,4.0,UNK,METOPROLOL; OMEPRAZOLE; ASPIRIN [ACETYLSALICYLIC ACID],,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Back pain', 'Chest discomfort', 'Chest pain', 'Hypertrophic cardiomyopathy', 'Hypoaesthesia']",1,MODERNA,OT 1049284,VA,,F,"Died; A spontaneous report was received from a consumer concerning a 58-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient was died. The patient's medical history was reported as underlying health issue. Concomitant product use was not provided by the reporter. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: if reported or unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, patient with underlying health issue died after getting the Moderna COVID-19 vaccine. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on an unknown date. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a 58-year-old female who died on unknown date after first dose of mRNA-1273, lot # unknown. Very limited information regarding this event has been provided at this time, therefore it is difficult to assess a cause and effect relationship. No further information will be available. Of note, patient's medical history included unknown underlying health issues.; Reported Cause(s) of Death: Unknown cause of death",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: Unevaluable event (underlining health issue),,,['Death'],UNK,MODERNA,OT 1049285,IL,42.0,M,"Difficulty breathing; Allergic reaction; Pain in the arm that radiated up to the neck; Hot and cold flashes; Hot and cold flashes; A spontaneous report was received from a consumer, who was also a 43-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an allergic reaction, hot and cold flashes, difficulty breathing and pain in the arm that radiated up to the neck. The patient's medical history, as provided by the reporter, included asthma and allergies. Concomitant medications were not reported. On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 026L20A; expiration date: 28 Jul 2021) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 15 Jan 2021, four hours after vaccination, the patient experienced hot and cold flashes and pain in his arm that radiated up to his neck. He had some food and went to bed. The next day, on 16 Jan 2021, the patient had an ""adverse reaction, allergic reaction"". This event was considered to be medically significant. treatments at home but had no relief. The patient still had trouble breathing so he went to the emergency room as his physician told him to. He was given three more nebulizers of ipratropium bromide (+) albuterol sulfate, steroids, diphenhydramine hydrochloride, and famotidine but he still had trouble breathing. Therefore, the patient was admitted into the hospital for observation. The patient was discharged on 17 Jan 2021 with two to three bags of normal saline and four bags of ""lactose ringers"". In addition, his physician put him on a steroid and inhaler. Action taken with mRNA-1273 in response to the events were not reported. The outcomes of the events, allergic reaction, difficulty breathing, hot and cold flashes, and pain in the arm that radiated up to the neck, were unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Of note, patient's significant medical history included asthma and allergies.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/15/2021,01/15/2021,0.0,UNK,,Allergy (has allergies (not specified)); Asthma,,,,"['Chills', 'Dyspnoea', 'Hot flush', 'Hypersensitivity', 'Pain in extremity']",1,MODERNA,OT 1049286,TX,66.0,F,"got 3 vaccinations; Sore; Sleepy; Chills; Temp of 99.6�F; Interchanged covid-19 products; A spontaneous report was received from a consumer concerning a 66-years-old female patient, who received 3 doses of the COVID-19 vaccine. After the 2nd Moderna shot her arm got sore she felt sleepy, got the chills and had an elevated temp of 99.6�F, Interchanged covid-19 products. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Rosuvastatin 10mgxDay, Paroxetine 20mgxDay, Alendronate 70mg 1xWeek. The patient received her first of two planned doses of mRNA-1273 (Lot # 027L20A) on 06 Jan 2021. On 03 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot #013M20A) intramuscularly for prophylaxis of COVID-19 infection. Caller states that she received 3 doses of the COVID-19 vaccine. She received the Moderna vaccine on 06 Jan 2021 from a pharmacy. Then on Monday 01 Feb 2021 she received the 1st dose of the Pfizer's vaccine (and had a sore arm). The Pfizer's dose is EL9265. The pharmacy called for the 2nd Moderna dose on 03 Feb 2021. After the 2nd Moderna arm got sorer, she felt sleepy, got the chills and had a raised temperature of 99.6�F. Treatment information was not provided/unknown. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The outcome of the events, sore arm, she felt sleepy, got the chills and had an elevated temp of 99.6�F, Interchanged covid-19 products were unknown/not reported.; Reporter's Comments: This case concerns a 66-year-old female patient who received their second of two planned doses of mRNA-1273 (Lot: 013M20A), reporting Extra dose administered and Interchange of vaccine products, associated with Vaccination site pain, Somnolence, Chills and Pyrexia. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,02/01/2021,,UNK,ROSUVASTATIN; PAROXETINE; ALENDRONATE,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Body temperature increased', 'Chills', 'Extra dose administered', 'Interchange of vaccine products', 'Somnolence', 'Vaccination site pain']",2,MODERNA, 1049287,NY,16.0,F,"Patient received the first dose of the Moderna COVID-19 vaccine that was under 18 years of age; A spontaneous report was received from a healthcare professional concerning a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) (product administered to patient of inappropriate age). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12 Jan 2021, the patient received her first dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The Director of Medical Operations called in stating that it was reveled on 12 Jan 2021 that a patient in his clinic received the first dose of the Moderna COVID-19 vaccine that was under 18 years of age. The administration was made in error. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the event, patient received the first dose of the Moderna COVID-19 vaccine that was under 18 years of age, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1049288,GA,63.0,M,"received second shot early; A spontaneous report was received from a Reporter like a nurse concerning a �63 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event inappropriate schedule of vaccine administered. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the anatomical location for prophylaxis of COVID-19 infection. The patient is scheduled to receive his second shot on 19-FEB-2021, but received the vaccine (early) on, 09-FEB-2021. Action taken with mRNA-1273 in response to the events was not reported. On 09-feb-2021, the outcome of the events was unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,02/09/2021,18.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Inappropriate schedule of product administration'],2,MODERNA,OT 1049289,NY,,M,"received the 2nd dose 20 days after the 1st one; A spontaneous report was received from a health care professional, concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient received the 2nd dose 20 days after the 1st one. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On an unknown date, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On an unknown date, it was reported that the patient received their second dose 20 days after receiving their first vaccination. Action taken with study drug was not applicable as the subject had already received both scheduled doses The outcome of the event, the patient received the 2nd dose 20 days after the 1st one was resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273 (lot# unknown) with no associated AEs reported after the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history.),,,['Inappropriate schedule of product administration'],2,MODERNA, 1049290,WA,17.0,F,"Gave vaccine to 17 year old; A spontaneous report was received from a nurse concerning a 17-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event, gave vaccine to a 17-year-old/inappropriate age of dose of administration. The patient's medical history was not provided. Concomitant medications were not reported. On 05 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A) for prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient received the vaccine resulting in the event of inappropriate age of dose of administration. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, gave vaccine to a 17-year-old, was considered resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 013M20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1049291,TN,,U,"a person who received 2 doses of the vaccine in a fairly quick succession; A spontaneous report was received from a health care professional, concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported the patient had received 2 doses of the vaccine in a fairly quick succession. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On an unknown date, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On an unknown date, it was reported that the patient received both doses of the vaccine in a fairly quick succession. Action taken with study drug was not applicable as the subject had already received both scheduled doses The outcome of the event, a person who received 2 doses of the vaccine in a fairly quick succession was resolved.; Reporter's Comments: This report refers to a case of ""Product administration error"" for mRNA-1273, lot # unknown. with no associated adverse events..",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Inappropriate schedule of product administration'],2,MODERNA, 1049292,CO,,F,"Received a partial dose during their second dose of Moderna; the needle coming off during administration; A spontaneous report was received from a healthcare professional concerning a 76-year-old female patient, who received a partial dose during her second dose of Moderna vaccine administration / MedDRA PT: underdose due to the needle coming off during administration /MedDRA PT: device connection issue. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received her first of two planned doses of mRNA-1273 (Lot number not provided) on an unknown date. On 07-Feb-2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of Covid-19 infection. It was reported that a female patient did not get the full dose of the Moderna vaccine due to the needle coming off during administration. No further information was provided. Treatment information was unknown. Consent given to follow-up. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The events, received a partial dose during her second dose of Moderna vaccine due to the needle coming off during administration, were considered resolved.; Reporter's Comments: This report refers to a case of underdose and syringe issue for mRNA (lot # unknown) with no reported AEs in the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/07/2021,02/07/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Device connection issue', 'Underdose']",2,MODERNA,OT 1049293,OR,,U,"Syringe Leaked (Suboptimal Dose administered); Syringe Leaked (Suboptimal Dose administered); A spontaneous report was received from a physician concerning a patient of unknown/undisclosed age and gender who experienced syringe leak (Suboptimal Dose Administered) and underdose The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 3FEB2021, the patient received one of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. Female Physician called to report that while mass-vaccinating with the Moderna COVID-19 vaccine on 3FEB2021, the syringe leaked on two cases. She reported the needle was not properly attached to the barrel. As a result, two patients possibly did not receive the full dose of the Vaccine. Action taken with mRNA-1273 in response to the events was not provided. The events, syringe leak (Suboptimal Dose Administered) and underdose, was considered recovered/resolved or recovered/resolved.; Reporter's Comments: This report refers to a case of underdose and syringe issue for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Device connection issue', 'Underdose']",1,MODERNA,OT 1049294,IA,37.0,F,"Unsure if shot was administered intramuscularly in the deltoid; Muscles on the whole right side of her body are flaring up and tensing up; The big gland in her axillary area are really big; Scapula and shoulder blade area was very tense and balling up; Arm was sore; A regulatory authority report was received from a healthcare professional concerning a 37-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced unsure if shot was administered intramuscularly in the deltoid, muscles on the whole right side of her body are flaring up and tensing up, arm was sore, the big gland in her axillary area are really big and her scapula and shoulder blade area was very tense and balling up. The patient's medical history was not provided. No relevant concomitant medications were reported. On 15 Jan 2021, approximately 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot 025L20A) intramuscularly in the right, dominant arm for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient received first shot in right, dominant arm at the peak of shoulder, between the clavicle and humerus and is unsure if shot was administered intramuscularly in the deltoid. She reported the muscles on the whole right side of her body flared and tensed up, arm was sore, the big gland in her axillary area was really big and her scapula and shoulder blade area was very tense and balling up. Treatment for the event included paracetamol, diphenhydramine citrate, and ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The event, unsure if shot was administered intramuscularly in the deltoid, was considered resolved on 15 Jan 2021. The outcomes of the events, muscles on the whole right side of her body are flaring up and tensing up, arm was sore, the big gland in her axillary area are really big and her scapula and shoulder blade area was very tense and balling up, were unknown.; Reporter's Comments: This report refers to a 37 Y/O female who had NS event Product administered at inappropriate site with NS unexpected Muscle tightness, Musculoskeletal stiffness, and NS expected Injection site lymphadenopathy, Injection site pain. Event onset the same day as first dose mRNA-1273. Treated with paracetamol, diphenhydramine, ibuprofen. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Injection site lymphadenopathy', 'Injection site pain', 'Muscle tightness', 'Musculoskeletal stiffness', 'Product administered at inappropriate site']",1,MODERNA,OT 1049295,,,F,"received both doses of the Moderna Covid-19 vaccine 2 weeks apart not 1 month.; A spontaneous report was received from a consumer concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced receiving both doses 2 weeks apart/inappropriate schedule of vaccine administration. The patient's medical history is not provided by the reporter. Concomitant medications were not reported. The patient received their first and second of two planned dose of mRNA-1273 on an unknown date (Lot number: unknown). Per the patient, a second dose was received 2 weeks after the first, not 1 month. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event is unknown.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Inappropriate schedule of product administration without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Inappropriate schedule of product administration'],1,MODERNA,OT 1049296,OR,,U,"Did not receive full dose; Fell drops on their arms; A spontaneous report was received from a Healthcare Professional concerning a patient who was administered Moderna's COVID-19 vaccine and did not receive full dose. The patient medical history was not included. Patient concomitant was not included On 07-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) prophylaxis of COVID-19 infection. Caller states there were 2 patients that received the vaccine on 07-feb-2021. The needles were not attached completely and they did not receive the full dose. The patients fell drops on their arms. She reported this through VAERS. She wants to know if she should repeat the shot or continue. Treatment of these event (s) were not provided. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was unknown/not reported; Reporter's Comments: This report refers to a case of underdose and exposure via skin contact with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/07/2021,02/07/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Exposure via skin contact', 'Underdose']",1,MODERNA,OT 1049297,NJ,,F,"administered ""10 cc""; A spontaneous report was received from a healthcare professional concerning a 63-year-old female patient who stated that after her injection she asked the nurse what dose she received and the nurse stated she administered ""10 cc""/accidental overdose. The patient's medical history included allergy to hydromorphone hydrochloride (has severe vomiting), diabetes and hypertension. Products known to have been used by the patient included insulin detemir, insulin aspart, carvedilol, and losartan. On 08 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. After the injection, the consumer asked the nurse what dose she received, and the consumer reported that the nurse stated she was administered ""10 cc"". The consumer stated she was going to call the vaccination site back to verify what dose she was given. She reported that she isn't experiencing any adverse events or side effects after the vaccination. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the event was not reported.; Reporter's Comments: This case concerns a 68-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 039K20A), reporting accidental overdose without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/08/2021,0.0,UNK,LEVEMIR; NOVOLOG; CARVEDILOL; LOSARTAN,Diabetes; Drug allergy (allergy to Dilaudid (severe vomiting)); Hypertension,,,,['Accidental overdose'],1,MODERNA,OT 1049298,NY,,U,"nurse mistakenly administered 0.1ml of the vaccine to 8 patients; gave the remaining dose of the vaccine; A spontaneous report was received from a physician concerning eight patients who received Moderna's COVID-19 vaccine (mRNA-1273 and were mistakenly administered 0.1ml of the vaccine, returned and rest of the full dose was administered. Medical history for patients was not provided, nor were any concomitant medications. On an unspecified date, a nurse in a physician's office administered the incorrect dose of mRNA-1273 for prophylaxis of COVID-19 infection to eight patients. Lot number was not reported. Injection site not provided. Seven of the eight patients came back to have the rest of the full dose administered. Physician wanted to know if this was the correct course of action. No other actions taken with mRNA-1273 were reported. Outcome for this event, eight patients receiving the incorrect dose of the vaccine was considered resolved.; Reporter's Comments: This is a case of vaccine exposure in a patient of unknown age and gender who was mistakenly administered 0.1ml of the vaccine (vaccine underdose) and rest of the full dose was administered (extra dose administered) for mRNA-1273 vaccine Lot # unknown. There was no associated adverse event reported for the events of underdose and extra dose administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical history not provided),,,"['Extra dose administered', 'Underdose']",2,MODERNA, 1049299,IL,,U,"Administered the second dose of the Moderna COVID-19 vaccine today (09 Feb 2021) seventeen days from the first dose (22 Jan 2021); A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and patient was administered the second dose of the Moderna COVID-19 vaccine today (09 Feb 2021) seventeen days from the first dose (22 Jan 2021). The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 on 22 Jan 2021 intramuscularly for prophylaxis of COVID-19 infection. The patient received their second of two planned doses of mRNA-1273 on 09 Feb 2021 intramuscularly for prophylaxis of COVID-19 infection. HCP (healthcare professional) reported that a patient was administered with the second dose of the Moderna COVID-19 vaccine today (09 Feb 2021) seventeen days from the first dose (22 Jan 2021). No further information was reported. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable. The outcome of the event was unknown. The reporter did not provide an assessment for the event, patient was administered the second dose of the Moderna COVID-19 vaccine today (09 Feb 2021) seventeen days from the first dose (22 Jan 2021).; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,02/09/2021,18.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Inappropriate schedule of product administration'],1,MODERNA,OT 1049300,WA,16.0,F,"16 years of age, received the first dose; A spontaneous report was received from a Pharmacist concerning a 16-year-old, female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273), resulting in the event, 16 years of age, received the first dose/product administered to patient of inappropriate age. The patient's medical history was not provided. No relevant concomitant medications were reported. On 09 Feb 2021, the patient received their first of two planned of mRNA-1273 (Lot number: 011M20A) Intramuscularly in the right arm for prophylaxis of COVID-19 infection Pharmacist called in 09-FEB-2021 to report giving first dose of mRNA-1273 to a female patient 16 years of age. The pharmacist inquired if the dose regimen should be discontinued or completed with the second dose when due. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The event, 16 years of age, received the first dose, was considered resolved on 09 Feb 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 011M20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1049301,MA,,M,"Instead of the injection being injected into the delta muscle, he received it in teh bursa area of his shoulder; A spontaneous report was received from a consumer concerning a male patient who received an Moderna vaccine injection into the wrong body part (bursa). The patients medical history was not provided. Concomitant product use was not provided/unknown by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 01-FEB-2021 in the bursa area of his shoulder for prophylaxis of COVID-19 infection. Instead of the injection being injected into the delta muscle, the patient received it in the bursa area of his shoulder. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The event was considered recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Incorrect route of product administration'],1,MODERNA,OT 1049302,CT,,F,"COVID arm reaction, was diagnosed as cellulitis; A spontaneous report was received from a healthcare professional concerning a female patient who developed ""covid arm"" reaction, diagnosed as cellulitis/PT: cellulitis. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, the patient received dose of mRNA-1273 (Lot #, route of administration, and injection site unknown) for prophylaxis of COVID-19 infection. On an unknown date, the patient had ""covid arm"" reaction, went to the emergency room (ER) and was diagnosed as cellulitis and treated that way. Treatment details were unknown. Action taken with mRNA-1273 was not provided. The outcome of event ""covid arm"" reaction, diagnosed as cellulitis was unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced a serious unexpected event of cellulitis in the arm occurring with unknown latency after the first dose of mRNA-1273. Treatment for cellulitis. Outcome not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Cellulitis'],UNK,MODERNA,OT 1049303,,,U,"accidentally administered 1mL instead of the standard 0.5mL; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) was given twice the amount of the vaccine. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 09 Feb 2021, the patient received accidentally administered 1mL instead of the standard 0.5mL dose to a patient. The pharmacist was not in the office and did not have access to the Patient Information or Medical Information. Pharmacist is inquiring about the most common side effects reported with the Moderna COVID19 Vaccine. Pharmacist would like to receive information via email. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided The event gave twice the amount of the vaccine was considered resolved on 09 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered, and overdose for mRNA-1273 with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,02/09/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Accidental overdose'],UNK,MODERNA, 1049304,MO,71.0,F,"Lots of bloating; Not feeling good; Arm got really sore; Afib; Lots of chills; Redness itching at the injection site; Itching at the injection site; A spontaneous report was received from a consumer who is a 71-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed atrial fibrillation, arm got really sore, redness itching at the injection site, lots of bloating, lots of chills and just not feeling good, The patient's medical history included tachycardia, COVID-19, atrial fibrillation, asthma and lung inflammation. Products known to have been used by the patient, within two weeks prior to the event, included diltiazem, flecainide and rivaroxaban. On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) in the left arm intramuscularly for prophylaxis of COVID-19 infection. On 10 Feb 2021, at noon, post vaccination, the patient reported she had atrial fibrillation. She was able to get it under control until it started back again at approximately 4 pm the same day. At 6 pm that evening, the patient reported her arm was really sore, there was redness and itching at the injection site. She had lots of bloating, chills and overall, not feeling good. The patient stated it felt like having COVID again. Treatment for the event included hydrocortisone cream. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, afib/atrial fibrillation, was considered not resolved. The outcome of the events arm got really sore, redness itching at the injection site, lots of bloating, lots of chills, just not feeling good, and feeling like having COVID all over again were considered unknown. Follow-up received on 16 Feb 2021 included date of when patient had COVID-19, treatment information and added redness and itching at the injection site to the events.; Reporter's Comments: Based on the current available information, which includes a strong temporal association with onset of the reported events and the use of the product, a causal association cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/10/2021,0.0,UNK,DILTIAZEM; FLECAINIDE; XARELTO,AFib; Asthma; Tachycardia,Medical History/Concurrent Conditions: COVID-19 (Patient reported she had COVID-19 in November 2020.); Lung inflammation,,,"['Abdominal distension', 'Atrial fibrillation', 'Chills', 'Injection site erythema', 'Injection site pruritus', 'Malaise', 'Myalgia']",1,MODERNA,OT 1049305,AL,,F,"Deviation from time-frame: second shot on the 42 day; A spontaneous report was received from a Reporter like HCP concerning a 53 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inappropriate schedule of vaccine administration. The patient had an emergency dental procedure because root canal was not done properly. Concomitant medications included cymbalta 30 mg and bystolic 5 mg. The patient is on antibiotics and steroids. On Date 31-DEC-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) in the Left arm for prophylaxis of COVID-19 infection and on 09-FEB-2021 patient received second of two planned doses in right arm (lot/ batch: Not provided). On 9-FEB-2021, the patient experienced her second shot on the 42nd day after the first vaccine. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event ""deviation from time-frame: second shot on the 42 day"" was considered resolved on 09-FEB-2021.; Reporter's Comments: This case concerns 53 year old female patient who received second of two planned doses in right arm (lot/ batch: Not provided) 42 days after the first dose. No reported adverse events after the vaccine was administered in this case of inappropriate schedule of product administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,02/09/2021,40.0,UNK,CYMBALTA; BYSTOLIC,,Medical History/Concurrent Conditions: Root canal procedure,,,['Inappropriate schedule of product administration'],2,MODERNA,OT 1049306,,,F,"Angioedema; Swelling around surgical clips in her mouth; A spontaneous report was received from a health care professional concerning a female patient (age unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angioedema and swelling around surgical clips in her mouth. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, the patient received one of two planned doses (first or second dose not specified) of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced angioedema and swelling around surgical clips in her mouth. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events, angioedema and swelling around surgical clips in her mouth, was not reported.; Reporter's Comments: This case concerns a female of unknown age who had a serious unexpected event of angioedema and a nonserious unexpected event of mouth edema. The events occurred with unknown latency after both the first dose of mRNA-1273. Treatment information not reported. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Angioedema', 'Oedema mouth']",1,MODERNA,OT 1049311,PA,72.0,F,"Headache began the evening after receiving the vaccine by the next day, headache pain more than a 10. After consulting dr who told her to take Tylenol. Tylenol has brought the pain level to about 7, 2 weeks later.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/10/2021,02/11/2021,1.0,PUB,"Synthroid, Vit B12",None,Pernicious Anemia,,penicillin,['Headache'],1,MODERNA,IM 1049312,NV,47.0,M,"Finger nodule on the right hand, ring finger.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/23/2021,5.0,PUB,Fish oil - 12 years,None,None,,None,['Nodule'],1,PFIZER\BIONTECH,SYR 1049313,CO,70.0,F,"2 hrs. After injection mild chills & fatigue. 14 hrs. After injection mild chills, mild headache, very tired/fatigue, moderate to severe upper body muscle aches, mild migratory chest pains for about 30 minutes. 24 hrs after injection just overwhelming fatigue& mild headache continued for another 12 hrs. 48 hrs. After injection symptoms gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,OTH,"Levothyroxine, pantoprazole, fluticasone nasal spray, zyrtec",None,Hypothyroid GERD Environmental allergies,,Environmental only,"['Chest pain', 'Chills', 'Fatigue', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH,IM 1049314,IL,62.0,M,"PAIN, HEADACHE, AND FEVER",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/18/2021,1.0,OTH,,,,,,"['Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 1049315,OH,94.0,F,"Red, itchy rash on arm 2 days after injection Very sore arm 1 day after injection and slightly swollen arm at injection site A feeling of heaviness in the arm Some Nausea 3 days after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/22/2021,2.0,PUB,Levothyroxine Prilosec Hydrochloride Carvedilol Pravastatin,None,COPD,Covid 19 Moderna first shot had soreness in arm but no rash like the second shot.,Amoxicillin Albuterol,"['Erythema', 'Injection site swelling', 'Limb discomfort', 'Nausea', 'Pain in extremity', 'Pruritus']",2,MODERNA,SYR 1049316,KY,20.0,M,"Started with a fever that slowly worsened to a high temperature. This resulted in chills, aches, pains, fatigue. nausea, congestion, sore throat, headaches, and weakness. There was also swelling at the injection site and swelling of my eyelids.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,MIL,None,None,None,,None,"['Asthenia', 'Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Injection site swelling', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'Respiratory tract congestion', 'Swelling of eyelid']",2,MODERNA,IM 1049318,NJ,83.0,F,Develope a cough with chest pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/22/2021,5.0,PUB,Levothyroxine,None,None,,None,"['Chest pain', 'Cough']",2,MODERNA,SYR 1049319,NE,70.0,F,"Complaints of nausea, vomiting and chills. In the Emergency room. Had to have IV Zofran, promethazine, and Normal Saline Bolus.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,UNK,,,,,,"['Chills', 'Nausea', 'Vomiting']",UNK,MODERNA, 1049320,NC,72.0,F,"after 1 hour feeling light headed, felt drunk for 7 hours, elbow stiffness on right arm, numbing feeling on right arm, fingertips numbness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/15/2021,0.0,UNK,,,reduced kidney function,"triple booster 30 years ago-hot, fever/ flu vaccine-nov. 2020, sore throat , sore arm, tightness in chest",penicillin,"['Dizziness', 'Feeling drunk', 'Hypoaesthesia', 'Joint stiffness']",1,PFIZER\BIONTECH,IM 1049321,DE,71.0,F,"Moderna COVID-19 Vaccine EUA 14 hrs after dose 2, fever, chills, aches, 20 min AFIB. Back to sinus rhythm after 20 min on its own. 14 hrs after adverse effect started, fever normal, aches gone. Arm red, somewhat swollen. 6 hrs later, arm redder from injection site entire front of biceps down to elbow. Lump at bottom of biceps and enraged lymph node in armpit. 25 hours after noticing COVID arm, swelling down, lump on bicep gone and redness subsiding. Feeling good",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,OTH,"Azor Lipitor Multi Vitamin, Multi Minerals, Co-Q10, Omega 3, Calcium Magnesium and D3",None,None,,None,"['Atrial fibrillation', 'Chills', 'Erythema', 'Lymphadenopathy', 'Pain', 'Peripheral swelling', 'Pyrexia']",2,MODERNA,IM 1049322,NJ,52.0,F,Redness and palpable swelling and injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,PVT,,,,,,"['Injection site erythema', 'Injection site swelling']",1,MODERNA,IM 1049323,MI,23.0,F,"Temperature, Short of breath, congestion, dizzy, muscle pain,Headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/30/2021,0.0,SEN,,,,,,"['Body temperature increased', 'Dizziness', 'Dyspnoea', 'Headache', 'Myalgia', 'Respiratory tract congestion']",UNK,MODERNA,IM 1049325,CO,70.0,F,"I began getting chills and felt feverish. I also had body aches and pains as when ill with the flu. There was a sense of nausea initially but it went away. There was pronounced feeling of heat located subcutaneously on my right outer thigh. It came and went about every minute or so. (I counted the seconds in between each incident). I am still experiencing flu like symptoms (bodily aches, slight headache, mild chest pain, and general ill-feeling.) I will contact my primary care physician today about my concerns but felt it necessary to document these mild but disturbing side effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/23/2021,1.0,PVT,none,none,"Asthma, chronic bronchitis, osteoarthritis, spinal stenosis",,zipro,"['Chest pain', 'Chills', 'Feeling hot', 'Headache', 'Influenza like illness', 'Malaise', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,IM 1049326,TX,54.0,F,"On the 19th I started getting a welt on it. it spread, got inflamed and swollen. It was hot to the touch. Dr. said I had cellulitis. prescribed antibiotics.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/19/2021,5.0,PUB,Vitamins - hair skin and nails Biktarvy,No,HIV Positive. undetectable. Biktarvy,,Sulfa,"['Cellulitis', 'Feeling hot', 'Inflammation', 'Swelling', 'Urticaria']",1,MODERNA,SYR 1049327,IL,59.0,U,"CHILLS, NAUSEA, DIZZINESS, AND HEADACHE.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/17/2021,0.0,OTH,,,,,,"['Chills', 'Dizziness', 'Headache', 'Nausea']",1,MODERNA,IM 1049328,CO,61.0,F,"sudden onset pain left armpit radiating down to elbow and into left breast and back. Severe. Treated at ER with percoset and turadol and aspirin. Tested for blood clots, heart attack, lymph node anomaly. Everything tested came back as normal. Sent home. Used naproxen and hydrocodone and ice at home. discomfort continues but is bearable now (next day) with drugs and ice. Note: Took monthly Cosentyx shot on Feb 20, 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/22/2021,9.0,PVT,Cosentyx,"urinary tract infection symptoms, negative culture",psoriatic arthritis,,lactose intolerant,"['Axillary pain', 'Computerised tomogram', 'Electrocardiogram normal', 'Fibrin D dimer normal', 'Full blood count normal', 'Metabolic function test normal', 'Pain', 'Troponin normal', 'Ultrasound scan normal']",UNK,MODERNA, 1049329,LA,60.0,F,"Abdominal cramps and loose bowels; nausea, and chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/05/2021,1.0,PHM,"Esomprazole 40 mg, daily; Rosuvatatin 10 mg, hs; Amlodopine/Valsartan 10/320 mg, daily; Zinc 220mg, hs; Vit C 100mg w citrus bioflavonoids & rose hips, bid; Cetirizine 10mg; hs; CoQ 10 100 mg, hs",Hypertension,,,,"['Abdominal pain', 'Chills', 'Diarrhoea', 'Nausea']",1,MODERNA,IM 1049330,CA,48.0,F,"Received vaccine 1/15/21. 3 days later, developed axillary LAD ipsilateral to vaccine administration. The next day, developed upper back pain. Symptoms have persisted for >1 month and not responding to OTC pain medication.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/18/2021,3.0,PVT,,,,,,"['Back pain', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 1049332,GA,65.0,F,"Pt. in for a second dose of Covid Vaccine, Moderna, arrived in observation unit with c/o pain in the spine and tightness in the chest w/o s/s of sob, nausea, vomiting. Pt. states did not have any occurences with the first vaccine. Patient was transported to higher level of care via W/C in no acute distress.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/17/2021,16.0,PVT,Humulin NPH Humulin R Losartan Pradaxa,None,DM 1 Thyroid Goiter Osteporosis Hx of DVT Hyperchloesterolemia,,Aspartame Morphine Coedine Lisinopril Simvastatin PCN Class,"['Chest discomfort', 'Spinal pain']",2,MODERNA,IM 1049334,IA,53.0,F,"3 pregnancies (last in 2000). Moderna vaccine. Chest rash started and has progressively moved from chest to back/neck over the past week. Woke up today and it is on my left arm (faintly). Concerned because I am due for #2 on Friday, 2/26. Also - I had Covid 19 infection on 10/30/2020. I had mild fever, body aches, lost taste/smell for 1.5 months, and had vertido N/V on Day #10. Nop coiugh but congestion for 2 days. Full recovery.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/15/2021,17.0,PHM,"Nexium 10 mg, lutein 20 mg, escitalopram 20 mg, cetirizine 10 mg, Flonase (1 puff) each nare.",Received toradol injection 01/29/2021 (day of SARs vaccine).,GERD,,PCN (hives); have had derivatives of PCN (cephalosporins) without problems. Mouth can get tingly with oranges.,"['Ageusia', 'Anosmia', 'COVID-19', 'Nausea', 'Pain', 'Pyrexia', 'Rash', 'Respiratory tract congestion', 'SARS-CoV-2 antibody test negative', 'Vertigo', 'Vomiting']",1,MODERNA,IM 1049335,NV,29.0,F,"Rash developed on left arm below vaccination and went across the chest and then 24 hours later hives on face and behind ears and some on shoulders and arms client took Benadryl by pm the face was red without hive and by Sunday the Hives had disappeared. Monday redness on face and by Tuesday all hives had resolved. Tuesday still very weak and fatigued and if sits upright HR increases, eating and drinking without interruption.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,PUB,"Take birth control, Zyrtec and singular OTC multi vitamins",Client denies,Autoimmune psoriatic arthritis,,"Tree nuts, PCN (Hives)","['Asthenia', 'Erythema', 'Fatigue', 'Injection site rash', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 1049336,MA,33.0,F,"Red stripe on arm, approximately 4"" long and 2"" wide, showed up sometime between 2/22/21 (not noticed after morning shower) and 2/23/21 7:30am (noticed after morning shower). Smooth and not hot to touch. Slightly itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/23/2021,11.0,OTH,Trintellix 5mg,None,Polycystic ovarian syndrome,,"Sulfa, scallops","['Erythema', 'Pruritus']",1,MODERNA,IM 1049337,AZ,69.0,M,Severe joint pain in left hand. Treated with CBD oil and exercise. Severe pain subsided within two hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/23/2021,1.0,UNK,,,"Gout, heart and vascular disease",,Statins,['Arthralgia'],1,PFIZER\BIONTECH,IM 1049338,RI,84.0,F,pt c/o dizziness and feeling weak in the legs approximately 15 post vaccination. On scene provider notified. Pt notified to be observed for an additional 15 mins. Pt stated felt fine after second observation period. No further action needed.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/23/2021,3.0,PUB,Lorstatin,none,"Diabetes, HTN, Hypercholeroltemia",,"NKDA, NKFA","['Dizziness', 'Muscular weakness']",1,MODERNA,IM 1049339,FL,25.0,F,"Fever, chills, nausea, aching joints and body, headache, burning prickly skin",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,PUB,"Adderall, Lexapro, Trazodone, Kurvelo, Sumatriptan, Aimovig",,Migraines,,,"['Arthralgia', 'Chills', 'Headache', 'Nausea', 'Pain', 'Paraesthesia', 'Pyrexia', 'Skin burning sensation']",UNK,PFIZER\BIONTECH, 1049340,IA,70.0,F,"pt stated that went to bed w/ a sore are the night after receiving the covid vax. She woke up the next day w/ unbearable pain all over her body, body aches, joint pain, head ache, back ache. She felt like she had fever but she said it was only 99. Her left arm was swollen, red and hot around the injection site. Pt states she still has shaky, achy legs and swelling in left arm. Pt called her PCP and left message for them to give her a CB.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,PVT,"levothyroxine 100mg, lisinopril 10mg, Cymbalta 60mg, gabapentin 100 mg x 2 daily, clonazepam 1mg- 1 tab x 3 daily prn, B Complex, Multivitamin, Vitamin C 1000mg, Calcium +D3 800 mg, magnesium 500mg, Zinc 50mg, garlic 1000mg x 2 daily, asp",,"IBS, arrhythmia, spinal stenosis of spine and neck",,"penicillin, large doses of aspirin, codeine, morphine,","['Arthralgia', 'Back pain', 'Headache', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Tremor']",1,PFIZER\BIONTECH,IM 1049341,PA,64.0,F,Tinnitus-especially in Left ear. Previously had a very mild Tinnitus in both ears prior to vaccine. Woke up after 2nd vaccine with extreme tinnitus in left ear. Extreme ringing and muffled hearing in left ear. Right ear remains mild tinnitus. Went to ENT physician and saw NP and had hearing test performed. Mild hearing loss noted but no previous ear testing performed to compare results to. No other interventions available at this time.,Not Reported,,Not Reported,Not Reported,,Yes,N,01/27/2021,01/28/2021,1.0,PVT,Topiramate 25 mg. x 3 tab. per day,none,none,,none,"['Acoustic stimulation tests abnormal', 'Deafness', 'Ear, nose and throat examination abnormal', 'Hypoacusis', 'Tinnitus']",2,MODERNA,IM 1049342,AZ,48.0,F,Significant Left under arm swelling (area swollen approximately size of baseball in half) Significant pain under left arm Redness along outside of left breast Pain in Left breast Pain Left shoulder to Left elbow Nausea and hot flashes - Mild,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/23/2021,3.0,UNK,None,None,NOne,,None,"['Arthralgia', 'Axillary pain', 'Breast pain', 'Erythema', 'Hot flush', 'Lymphadenopathy', 'Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 1049343,,,U,"FATIGUE, BODY ACHES, AND HEADACHE.",Not Reported,,Not Reported,Not Reported,,Not Reported,,,,,UNK,,,,,,"['Fatigue', 'Headache', 'Pain']",1,MODERNA,IM 1049344,CA,45.0,F,"fever, chills, joint pain, nausea, headache, overall pain, insomnia",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,PVT,"venlafaxine, trazodone, methylphenidate, lamictal, topiramate, spironolactone, probiotics, prebiotics, folate",none,"depression, migraines",,,"['Arthralgia', 'Chills', 'Headache', 'Insomnia', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1049345,TX,75.0,F,"She has completed both moderna vaccines first one 01/17/21 and 2nd one 2/4/21. on 02/21/21 she started with unexplained HIVES over arms, abd and back. She has never had hives before She took benadryl which helped some and was given cetirizine and triamcinolone.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/21/2021,17.0,PVT,Eliquis and Sotalol,none,Atrial Fib GERD,,NKA,"['Inappropriate schedule of product administration', 'Urticaria']",2,MODERNA,IM 1049346,NV,67.0,F,"When she had thyroid cancer she had radiation, and the radiation caused a burning mouth sensation 10-12 years ago. Is on medications for that which help. With the injection this sensation worsened within the last day or two. Spoke with her doctor who told her to increase her medications as it can exacerbate after a vaccine. She still having the symptoms and has an APT with her PCP this afternoon.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/21/2021,3.0,PHM,"Levothyroxine, Pantoprazole, Klonopin, Pravastatin, Zetia, baby aspirin, Lunesta, Lamictal, fish oil, calcium, vitamin D, zinc,",None.,"Breast cancer, thyroid cancer, heart stent.",,None,"['Condition aggravated', 'Oral discomfort']",2,PFIZER\BIONTECH,IM 1049347,FL,53.0,M,Cramping /itching/spots on body,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2020,02/02/2021,373.0,PVT,B12/Lisinopril/CHOLECALCIF/CYANOCOBALAMIN/DULOXETINE/THIAMINE,none,lower back pain,,none,"['Laboratory test', 'Muscle spasms', 'Pruritus', 'Skin discolouration']",UNK,MODERNA, 1049348,MI,46.0,F,"Fever, body ache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/31/2021,1.0,SEN,,,,,,"['Pain', 'Pyrexia']",UNK,MODERNA,IM 1049349,CA,73.0,M,night sweats body wet all night long,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/18/2021,2.0,PVT,none,none,none,,none,"['Hyperhidrosis', 'Night sweats']",2,PFIZER\BIONTECH,IM 1049350,GA,74.0,F,"Extreme chills, aches, fever, blurry vision, sweats then exhaustion. Those occurred until approximately 2am. Then night sweats, tired and achy. Today feel better but still night sweats altho not as bad.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,PVT,"Advair, zyrtec",None,Asthma,,Sulfa,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Night sweats', 'Pain', 'Pyrexia', 'Vision blurred']",2,MODERNA,IM 1049351,MO,62.0,F,"Approximately 6 hours after receiving the injection I started running a temperature of 102.7 and feeling absolutely terrible all over. Shortly there after I was having such sharp pains in my joints (pretty much all over) that I couldn't get out of a chair without much assistance. Then I couldn't walk only barely shuffle y feet with my husband holding onto me. I was very short of breath at this point with a pulse ox reading starting at 76 and finally reaching 88, but would not climb any higher. I was very nauseous and unable to eat or drink. The following day my temperature was still running 101, but not continuously. I still felt bad, but could shuffle walking without assistance and was still nauseous. I pretty much stayed in a recliner chair all that day, except to try to take a shower, which I really had a feeling I wasn't going to survive. I went to bed without dressing, because felt so bad. The next day I felt better, but was so short of breath I had to have a rolling chair to sit in to try to do something in the kitchen. By afternoon February 15, 2021 I was feeling better, Only shortness of breath when walking and my pulse ox was 92. Should I take the second Moderna vaccine?",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/12/2021,0.0,UNK,"Apidra, Lantus, ASA, Carvedilol,Atorvastatin,Hydrochlorothiazide,& Lisinopril","Diabetes, Cardiac, & Rheumatoid arthritis","Diabetes, Cardiac, & Rheumatoid arthritis",,PCN,"['Arthralgia', 'Body temperature increased', 'Dyspnoea', 'Feeding disorder', 'Feeling abnormal', 'Gait disturbance', 'Mobility decreased', 'Nausea']",2,MODERNA,IM 1049352,MI,27.0,F,"A few days after the vaccine I woke up to the lymph nodes in both sides of my neck swollen with the left being more affected than the right. On 1/13 my PCP advised rest, ibuprophen and tylenol to help with the pain. 1/14 I had to call out to work because I just couldnt move my neck from left to right.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/10/2021,3.0,SCH,"Birth Control Inplant, 800mg Ibuprophen",no,no,,"treenut, dogs and cats","['Impaired work ability', 'Lymphadenopathy', 'Pain']",1,PFIZER\BIONTECH,IM 1049353,MN,47.0,F,extreme headache lasting for 5 days. Felt immense pressure in whole head area. Headache not completely resolved with ibuprofen or acetminophen at maximum recommended doses . Headache did finally resolve after the 5th day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,WRK,none,none,none,reaction to influenza vaccine (hives) due to egg allergy . Subsequent influenza vaccines did not result in hives in recent year,"eggs, latex","['Head discomfort', 'Headache']",2,MODERNA,IM 1049354,,65.0,F,"Headache, Bodyache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/31/2021,1.0,UNK,,,,,,"['Headache', 'Pain']",UNK,MODERNA, 1049355,IA,20.0,F,"1 hour after vaccination L arm and neck were numb, L axillary lymph node swollen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,WRK,birth control pills vit C,none,none,,none,"['Hypoaesthesia', 'Lymphadenopathy']",1,PFIZER\BIONTECH,IM 1049357,MD,70.0,F,"Delayed cutaneous hypersensitivity. Nine days after my first vaccination, my arm became pink, swollen, and sore near the injection site. It remains that way as I submit this form xxx days later. I'm expecting the issue to resolve at some point, but am submitting this report for information purposes.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/20/2021,9.0,PHM,,,,,,"['Dermatitis allergic', 'Injection site erythema', 'Injection site pain', 'Injection site swelling']",1,MODERNA,SYR 1049358,CA,73.0,F,"About a week after the injection, I got a red rash that itched around the injection site that lasted about 4 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/17/2021,8.0,PHM,Multivitamin,,,I get sick after a flu shot for a few days.,,"['Injection site rash', 'Rash erythematous', 'Rash pruritic']",UNK,MODERNA, 1049359,ME,71.0,F,"This patient started to feel lightheaded and had a dry mouth approximately 5 minutes after receiving her Pfizer mRNA COVID-19 vaccine. Over the next 20 to 25 minutes she progressed to having a sensation of tongue swelling, then difficulty swallowing, then chest tightness. Her vital signs were stable throughout the observation period (blood pressure 144/74 and 150/70, pulse in the high 80s to low 90s, and oxygen saturation 96-98% on room air) and she was able to speak in full sentences without any respiratory distress. Her lungs were clear and she had no stridor. She never had any pruritic symptoms or rash/hives. Because of the progressive nature of her symptoms, however, I felt she needed emergency room evaluation for observation. We never administered any medication while at the vaccine clinic including epinephrine or Benadryl. After approximately 25 minutes, 911 was called and she was transported by ambulance to the emergency room in stable condition.",Not Reported,,Yes,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,OTH,"Levothyroxine, Simvastatin, Omeprazole, Venlafaxine, Alprazolam, Sumatriptan, Trazodone, Estrogen Cream, Biotin, Calcium, Vitamin D.",None.,"Hypothyroidism, Hyperlipidemia, GERD, Anxiety, Headaches, Vaginal Dryness, Osteopenia.",,"Sulfa Antibiotics, Amoxicillin, Flagyl.","['Chest discomfort', 'Dizziness', 'Dry mouth', 'Dysphagia', 'Swollen tongue']",UNK,PFIZER\BIONTECH,IM 1049360,IL,62.0,F,"FEVER, HEADACHE, AND CHILLS",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/19/2021,2.0,OTH,,,,,,"['Chills', 'Headache', 'Pyrexia']",1,MODERNA,IM 1049361,GA,65.0,F,Reported dizziness and lightheadedness 4 minutes after injection. VSS. Laid on stretcher for 30 minutes and felt good enough to go home.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/14/2021,0.0,PVT,Protonix Lopressor Flonase Meclizine,None,HTN GERD Lipid metabolism disorder,,Levaquin Phenergan Codeine,['Dizziness'],2,PFIZER\BIONTECH,IM 1049362,IA,22.0,F,"At 3:30pm after receiving vaccine patient began to notice itching of both arms and anterior of neck. Said she felt like she had something in had a lump in throat. She was given Benadryl 25mg tablet, orally and a ice pack placed on injection site due to complaint of pain in arm. BP was 118/80, pulse 80, respirations 16. She was alert, skin was pink, warm to touch and dry. 10 minutes later hives started to subside, BP was 116/72, pulse 68, respirations 16, skin was warm, pink and dry. 4:15pm left clinic site being driven by mother - no itching, no lump i throat, redness resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PUB,None,None,None,,history of Allery to penicillin/amoxicillin,"['Pain in extremity', 'Pruritus', 'Sensation of foreign body', 'Urticaria']",1,PFIZER\BIONTECH,IM 1049363,VA,68.0,F,"Red, bumpy rash started Feb.20, 2021 on upper right arm. At first, area was somewhat itchy and occasionally sensitive to touch. Bumps are disappearing and area became less red as time goes on but is still visible.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/20/2021,8.0,UNK,"Phenytoin 100 mg, low-dose aspirin, glucosamine-chondroitin, areds-2 eye vitamins",None,arthritis,,"penicillin, nuts","['Erythema', 'Pruritus', 'Rash papular', 'Sensitive skin']",UNK,MODERNA, 1049364,VA,41.0,F,I developed a relatively severe itch at the injection site. It lasted for about two weeks. I suspect it was an allergic reaction. It is not deterring me from getting the second shot and did not produce any other systemic anaphylactic symptoms. I used hydrocortisone on it for symptom relief.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,WRK,"Claritin, Naltrexone 50mg BID, Topiramate 200mg QD, lisinopril 10mg QD, sertraline 100mg QD, Pantoprazole 40mg QD, hydroxyzine 50mg QHS, Trazodone 75mg QHS, Symbicort 160/4.5mcg, 2 puffs BID, Zinc supplement QAM",None,"asthma, alcoholism (in remission), hypertension",,"Oysters, Penicillin",['Injection site pruritus'],1,MODERNA,IM 1049365,CA,47.0,F,"By next morning arm was red about the size of a quarter and sensitive to the touch and warm to the touch as well as Body aches, fatigue and joint pain. Later in the afternoon the red area around injection site started getting larger and itchy that was Sunday as my injection was given Saturday morning Monday still suffered from fatigue bodyaches and joint pain as well as redness on arm and itchiness the temperature of the site or the injection site was very warm too touch. By Tuesday the bodyaches and joint pain have begun to subside the arm is still painful to touch the redness is still extremely large around the site there?s still a knot at site of injection and it still itches but has mildly improved from day before.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,PVT,"Ibuprofen, Norco, multivitamin, biotin, magnesium, calcium, vitamin D, Mega red krill oil, gabapentin, hydroxychloroquine, arava, orencia, vitamin c, iron, vitamin B complex, Prozac, omeprazole, trazodone, Zyrtec.",Seasonal allergies a few days before due to high winds.,Rheumatoid arthritis and fibromyalgia and osteoarthritis and obesity,,Adverse reaction to macrobid,"['Arthralgia', 'Erythema', 'Fatigue', 'Feeling hot', 'Hyperaesthesia', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Pain', 'Pain in extremity']",2,MODERNA,IM 1049366,CA,57.0,F,"Evening of vaccine date, experienced chills, fatigue. on Day 2 she developed fever 99.4 & sweats, and chills continued. Day 3 developed pain under arm pit &, headache. Day 4 woke up tired, restless sleep due to chills, stuffy nose and cough. Self treating: Tylenol, rest, fluids. Tested on 2/22/21 for COVID due to cough and stuffy nose. Results pending.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,PVT,,,,,,"['Axillary pain', 'Chills', 'Cough', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Nasal congestion', 'Pyrexia', 'SARS-CoV-2 test', 'Sleep disorder']",2,MODERNA,IM 1049367,DE,72.0,F,Red Hives all over body very icitie,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,PHM,"Flonase gabapentin amlodipine Hydrochloride. Loraladine,vitamins-E,D,C,B,fish oil Ginkgo",No,No,,Penicillin,['Urticaria'],UNK,MODERNA, 1049368,,65.0,F,"Headache, bodyache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/31/2021,1.0,SEN,,,,,,"['Headache', 'Pain']",UNK,MODERNA,IM 1049369,CT,69.0,M,Arm felt extra heavy for 10 minutes. Hours later it became sore for a day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PHM,,,,,,"['Limb discomfort', 'Pain in extremity']",1,MODERNA,IM 1049370,AL,34.0,F,"The Moderna vaccine injection was placed in the acromion process above the deltoid. The placement was just below the joint of my left arm. Immediate burning/tingling sensation began. I was observed for 15 minutes and sent home anyway. I could not move my arm for 4 days. The pain level was a 9 out of 10. If I had to move or turn, I involuntarily would cry out in pain. There was no redness, rash or swelling at the injection site. Just intense pain that shot down the left arm to my middle and ring fingers, top of the hand, with pain in my left shoulder blade and mild pain in the left side of my neck. Fatigue and chills started the evening of day 1 and lasted 7 days. The fatigue intensified in day 2 and dissipated on days 5 and 6. No fever was present at any time. On day 2, the nausea started and I vomited twice- the night of day 4 and morning of day 5. Intense headaches with light sensitivity were present from the night of day 3 through day 6. These felt like extreme migraines. These, combined with nausea and arm pain, prevented/interrupted my sleep. I also had loose stools on days 2 and 4.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/14/2021,0.0,SCH,"doxycycline antibiotic, Mirena IUD, Yaz birth control pill",skin infection/acne,hearing disability,"yearly flu shot, chills and soreness",penicillin,"['Arthralgia', 'Burning sensation', 'Chills', 'Fatigue', 'Headache', 'Injected limb mobility decreased', 'Insomnia', 'Migraine', 'Nausea', 'Neck pain', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Photophobia', 'SARS-CoV-2 test negative', 'Vomiting', 'Wrong technique in product usage process']",1,MODERNA,SYR 1049371,ND,74.0,F,"ONE WEEK AFTER RECEIVING THE VACCINE, THE PATIENT HAD SWELLING, PAIN, AND A RASH THAT DEVELOPED AROUND THE INJECTION SITE. IT RESOLVED AFTER A FEW DAYS.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/19/2021,7.0,PHM,,None,No,,None,"['Injection site pain', 'Injection site rash', 'Injection site swelling']",1,MODERNA,IM 1049372,IN,56.0,F,Pain at sight of injection. Ongoing since injection (4 days) Fatigue - ongoing Fever - 100.8 - resolved on 3rd day Confused thinking - ongoing Body and muscle aches - resolved on 4th day,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,PVT,Levoxyl Antacid,None,None,,"Sulfa, PCN","['Fatigue', 'Injection site pain', 'Myalgia', 'Pain', 'Pyrexia', 'Thinking abnormal']",UNK,MODERNA,SC 1049373,OH,68.0,F,"rec'd on 2/12 and didn't have much of a reaction until 8 days later it felt like the shot was just received, arm began to sting and red and itchy and that's been since 2/12.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/20/2021,8.0,PVT,"Hydroxide for dry eye, hair skin and nails vitamin",No,no,,codeine and curry powder,"['Erythema', 'Pain', 'Pruritus']",1,MODERNA,IM 1049374,NY,67.0,F,"after administration, patient comes up with severe allergic reaction redness and rashes starting from left lower arm spreading all the way to the neck and swelling with patient itching and patient acknowledge and started saying he is having severe reaction. Epipen was administered and after about 4 to 5 minutes of administration of epipen all those reactions stopped and patient said he felt better and thank me for the care. I was going to call 911 but patient said he was ok and there is no need . Patient waited for another 25 to 30 minutes after the administration of epipen in the pharamacy area to observe the patient . Patient left after about 30 minutes with no further reaction",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PHM,none,metabolic disoders,immune system,,none,"['Erythema', 'Hypersensitivity', 'Peripheral swelling', 'Pruritus', 'Rash']",1,MODERNA,IM 1049375,CA,36.0,F,"Pain to left axilla with swelling, redness to inject site one week later, general fatigue x 1 week.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/14/2021,7.0,PVT,"Azelasthine, Flonase, MVI",Daily headaches,none.,,allergy to shellfish and bee stings,"['Axillary pain', 'Fatigue', 'Injection site erythema', 'Oedema peripheral']",1,PFIZER\BIONTECH,IM 1049376,MS,79.0,M,"HE WOKE UP AT 4:30 CONFUSED, TALKING OUT OF HIS HEAD, THEN WENT BACK TO SLEEP AND WOKE UP AT 0630 WITH HARD SHAKING CHILLS, JOINT PAIN (SHOULDERS AND KNEES), ALTHOUGH HE HAS HAD 2 TOTAL KNEE REPLACEMENTS), HEADACHE, FATIGUE AND MALAISE, AND TEMPERATURE OF 101,5(NOT RESPONSIVE TO EXTRA STRENGTH TYLENOL) 20BENADRYL 25MG EACH , PEPCID 20MG AND GATORAID. . COULD NOT RAISE EITHER ARMS AND STATED THAT THE ""BALL JOINTS"" IN SHOULDER WERE VERY PAINFUL. AT 4;20 PM TEMP WENT DOWN TO 101.4, AT 6;30 TEMP 100.3 AND 8:45PM TEMP 99.3. AFTER THIS HIS SYMPTOMS SUBSIDED EXCEPT FOR SORE ARM AND SHOULDERS, SIDE EFFECTS LASTED ABOUT 14 HOURS. BUT STRANGE THING HAPPENED ON 02/21/21 HIS ENTIRE MIDDLE FINGER ON LEFT HAND TURNED VERY RED, BUT NO SORENESS OR PAIN. , AND NO OTHER FINGERS WERE RED AND RESOLVED ON 2/22/21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,OTH,"IMMEDIATELY AFTER THE VACCINE, HE TOOK 1000 MG TYLENOL, 25GM BENEDRYL, 20MG FAMOTADINE,",NONE,COPD EMPHYSEMA,,CIPRO IV,"['Abnormal behaviour', 'Arthralgia', 'Chills', 'Confusional state', 'Fatigue', 'Headache', 'Malaise', 'Pyrexia', 'Skin discolouration', 'Tremor']",2,MODERNA,IM 1049377,NY,32.0,F,"Body aches, fever, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/23/2021,1.0,WRK,,,,,,"['Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1049378,IL,51.0,U,HEADACHES AND FATIGUE,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/18/2021,1.0,OTH,,,,,,"['Fatigue', 'Headache']",1,MODERNA,IM 1049379,GA,46.0,F,"Patient complained of worsening of a headache she experienced since 2/8/2021 after receiving the vaccine. Reported the headache was 8/10 on pain scale. She also reported she has hx of migraine headaches 2-3 times weekly. Was taken to ER via ambulance. She was given medications to control B/P and pain, then discharged to home after six hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,OTH,"Descovy, Propranolol, Amplodipine, Plavix, Amitrityline, Phenergan, Keppra","Seizures, Migraines",Blindness of Left eye,,"Torodol, Compazine, Imitrex","['Chest X-ray', 'Condition aggravated', 'Electrocardiogram', 'Headache']",1,PFIZER\BIONTECH,IM 1049380,IL,75.0,F,"LARGE RASH AND SORENESS AT INJECTION SITE ---WARM SENSATION , ITCTING SWELLING & UNSETTLING AND AGRAVATED FEELINGS THROUGH-OUT THE DAY",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/22/2021,14.0,PVT,none,none,none,,sulfa,"['Feeling abnormal', 'Feeling hot', 'Injection site pain', 'Injection site rash', 'Pruritus', 'Swelling']",1,MODERNA,IM 1049381,,21.0,M,"Chills, body ache, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/31/2021,1.0,UNK,,,,,,"['Fatigue', 'Feeling cold', 'Pain']",UNK,MODERNA,IM 1049382,FL,73.0,F,Extremely itchy rash at injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/22/2021,7.0,PUB,Synthroid,none,none,,none,"['Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 1049383,CT,85.0,F,"My mom had a fever, chills, aches all over, sore arm, and had 2 days of memory loss/crazy behavior. It was almost as if she had dementia - she repeatedly called myself and my daughter claiming that her phone didn't work and she needed help. She was trying to tell me a phone number but kept giving me random words instead. She doesn't remember talking to any one of us who spoke to her Saturday and Sunday. She was repeatedly asking what a specific button did on her TV remote, and would then ask again a few minutes later the exact same question. This went on for 2 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PUB,"Eliquis, Trulicity, hip (something) for UTI management","Rheumatoid arthritis, edema in leg due to lymphoma, pulmonary fibrosis/COPD","Rheumatoid arthritis, edema in leg due to lymphoma, pulmonary fibrosis/COPD",,None,"['Abnormal behaviour', 'Amnesia', 'Chills', 'Pain', 'Pain in extremity', 'Pyrexia']",UNK,MODERNA, 1049384,CT,27.0,F,"After receiving the first dose of the Covid-19 vaccine, I started feeling numbness in my left fingers within seconds. The injection site with in my left arm. Within 5 minutes, I felt some numbness in my lower lip on the right side. Within a few days, the numbness decreased along with my other, more common symptoms, such as fatigue and headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,UNK,,,,,Penicillin,"['Fatigue', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Immediate post-injection reaction']",UNK,PFIZER\BIONTECH, 1049385,,49.0,F,Vaccine was received on 02/19/2021 at 0738. Symptoms began on 02/19/2021 at 1000. She experienced diarrhea and fatigue.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,UNK,,,,,,"['Diarrhoea', 'Fatigue']",2,MODERNA,IM 1049386,,40.0,M,"Fever, sweating, chills, malaise, soreness, muscle and joint pain, nausea, tenderness at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,MIL,"Zyrtec, flonase, Vitamin D",None,"GERD, seasonal allergies, esophageal strictures",,None,"['Arthralgia', 'Chills', 'Hyperhidrosis', 'Injection site pain', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia']",1,MODERNA,IM 1049387,IL,80.0,F,"itchy, red, hot upper arm around injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/13/2021,1.0,OTH,"atorvastatin 20 mg lisinopril 10 mg Symbicort inhaler, 2 puffs q am",none,"hypertension, asthma, cholesterol",,benzocaine methylchloroisothiazinoline melamine formaldehyde,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",UNK,MODERNA,IM 1049389,ID,74.0,M,"Patient passed away Saturday at 14:04pm. Patient's wife reports his death was sudden, he passed away sitting in his chair his heart just stopped she said. They tried to perform CPR, 911 was called and paramedics arrived at the scene and he was given medication but never had any return of vital signs and so his death was called at the scene. Wife reports he was not ill, did not have any symptoms prior to the event. They are not going to be doing a autopsy. She wanted us to know based on timing that there may be some possible correlation with his COVID19 vaccine. He obtained the vaccine on 02/09/2021 - wife reports he had no symptoms, not even arm soreness after the vaccine. Had no fever, shortness of breath. Did not complain of chest pain. We can update chart to reflect the patient is deceased and lets make a card for the family.",Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/20/2021,11.0,PVT,"Spironolactone, Atorvastatin, Gabapentin, Trelegy Ellipta, Januvia, Xarelto, Losartan, Metoprolol Succinate.",No,"Type 2 DM, HTN, COPD, Hyperlipidemia unspecified, A-fib unspecified, Chronic pain, Morbid Obesity",,No,"['Cardiac arrest', 'Death', 'Resuscitation']",1,MODERNA,IM 1049390,WA,73.0,F,very rapid heart rate for 45 minutes 6 hours after vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,PVT,"synthroid, zyrtec, mucinex,",none,none,,"demerol, bee stings (anaphylaxis) , chlorhexidine,",['Heart rate increased'],1,MODERNA,UN 1049392,IN,54.0,M,"received 2nd vaccine on 2/14/21, on 2/16/21 started having cough, nasal drainage, fatigue. Went to urgent care on 2/23/21 and diagnosed with URI",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/23/2021,9.0,PVT,,,HIV,,"Sulfa, aripiprazole","['Cough', 'Fatigue', 'Rhinorrhoea', 'SARS-CoV-2 test negative', 'Upper respiratory tract infection']",2,PFIZER\BIONTECH,IM 1049393,NY,74.0,M,"After 1st vaccine, (1/18/21 the next day. Went to hospital 1/20/21. incoherent and loss of balance. Went to hospital for 3 days. After 2nd shot 2/15/21 he got a reaction 6 days later. Very incoherent, delusional and loss of balance, unable to walk. Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/21/2021,6.0,OTH,,"Parkinson?s, diabetes",Parkinson?s. Diabetes,,No allergies,"['Balance disorder', 'Delusion', 'Gait disturbance', 'Incoherent', 'Pyrexia']",UNK,MODERNA, 1049394,,24.0,F,"Fever, Headache, Nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/31/2021,1.0,UNK,,,,,,"['Headache', 'Nausea', 'Pyrexia']",UNK,MODERNA,IM 1049395,IL,46.0,F,"CANT LEFT RIGHT ARM, FEVER, AND DIZZINESS",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/19/2021,1.0,OTH,,,,,,"['Dizziness', 'Injected limb mobility decreased', 'Pyrexia']",1,MODERNA,IM 1049396,NJ,24.0,F,"Redness with moderate pain and mild swelling beginning at injection site and spread distally/down arm. Began small in size but currently approx. 3"" x 6"". Started 2 days after receiving second dose. I had no issue with the first dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/22/2021,2.0,OTH,Venlafaxine 75mg Nexplanon implant in right arm,,,,,"['Erythema', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Pain in extremity', 'Peripheral swelling']",2,MODERNA,IM 1049397,PA,69.0,F,Large red circle at the injection sight,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/23/2021,13.0,OTH,Effexor XR 75mg. Effexor XR 37.5 mg. Vitamin D. Magnesium. Probiotics.,Clogged eye oil gland,No,,None known,['Injection site erythema'],UNK,MODERNA, 1049398,AZ,70.0,F,"Delayed cutaneous reaction. Swelling, heat, redness, itch, soreness. Started 7 days after injection at site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/22/2021,7.0,OTH,"Sertraline Buspar, Calcium, Vitamin D",None,Osteoporosis Depression,,Artificial scent agents,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Skin reaction']",1,MODERNA,SYR 1049399,MA,40.0,F,"Headache, muscle pain, sore throat, fever, sinus pressure, difficulty focusing eyes, fatigue. Memorable symptoms began on Feb. 19th, the worst day was Feb. 20th, when I was unable to complete my usual daily activities. My symptoms have begun to improve today, Feb 23rd. On Dec. 17th, 2020 I was diagnosed with COVID19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/18/2021,2.0,PHM,Lithum Zoloft Lamictal Sprinolactone,,,,Amoxicillin,"['COVID-19', 'Fatigue', 'Headache', 'Loss of personal independence in daily activities', 'Myalgia', 'Oropharyngeal pain', 'Paranasal sinus discomfort', 'Pyrexia', 'Vision blurred']",1,PFIZER\BIONTECH,IM 1049400,WA,73.0,M,"I had no reaction to the initial vaccination. On February 21 ? 8 days after the vaccination ? I awoke with a bit of swelling, light redness, and a slight itch at the vaccination site. I understand this is called ""COVID arm"" and am only reporting it for research purposes. The swelling has not increased and I have no real pain. I have no concerns about this reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/14/2021,02/21/2021,7.0,PHM,"Lovastatin, fish oil, vitamin B, vitamin D, Tumeric, Glucosamine, multi-vitamin",none,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",UNK,MODERNA,IM 1049401,TN,76.0,F,"Pfizer-BioNTech COVID-19 first dose, 1/23/2021, little reaction. second dose, 2/13/2021: headache one day later, disorientation/foggy mind 2 days after, then cleared up, muscle pain was short-lived, moderate chills, feeling unwell with weakness, restless leg syndrome (managed since 2004 with medications) returned 10 days after second shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/14/2021,1.0,OTH,"levoxyl, clonazepam, fentanyl trasdermal, allergy injections",none,"allergic conjunctivitis & rhiinitis, osteoarthritis, facet nerve pain, restless leg syndrome (had cleared up), anxiety",,"inhalent allergies, food allergies (minor)","['Asthenia', 'Chills', 'Condition aggravated', 'Disorientation', 'Feeling abnormal', 'Headache', 'Malaise', 'Myalgia', 'Restless legs syndrome']",2,PFIZER\BIONTECH,IM 1049402,CO,74.0,F,"chills, muscle aching, fatigue Advil/Tylenol lasted about 5 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/01/2021,,PUB,Levothyroxin - propranolol - atorvastin - vitamin D - Calcium - potassium - vitamin c - magnesium oxide - Co Q 10 - fish oil,None,None,,Flecinaide,"['Chills', 'Fatigue', 'Myalgia']",2,MODERNA,SYR 1049403,NE,46.0,F,"About 3 hrs after the first dose, I had full body itching, severe chills, body aches, a severe headache, some swelling in my right arm with a red circe that lated about two weeks, lost all the skin on my hands both inside and out. This happened with both doses.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/04/2021,7.0,PVT,"I take Synthroid, Prenatal Vitamins, B complex, Biotin, Asprin, Prozac, Zocor, a Probiotic & Vitamin D.",No,No,Tetnus vaccine,"I have Celiac Disease so no gluten, eggs, shellfish, cantalope, bananas, avocados, soy & corn.","['Chills', 'Headache', 'Pain', 'Peripheral swelling', 'Pruritus', 'Rash erythematous', 'Skin exfoliation']",1,MODERNA, 1049404,CA,82.0,F,"Pt has hx of rash on bil arms with her first dose of Moderna and she denies no other reactions including shortness of breath , chest pain, dizziness, headaches, fever, difficulty breathing, dyspnea,dysphagia or wheezing. Pt does notes to have underlying dysphagia which is a chronic issue for pt. Today pt was here for her second Moderna Imm which she tolerated well but at 0845 am reported mild headache which to her seemed similar to her previous migraine headaches which she gets off and on . Denied any nausea vomiting, dizziness, chest pain, shortness of breath, dysphagia, dyspnea, wheezing or coughing or difficulty breathing. Pt was given water and crackers which helped her sx immediately. BP: 134/83 HR: 76 O2: 98% RR: 17. Neuro: pt A&O and able to follow instructions. Pt was monitored for 40 mins total and she left in stable condition.ER precautions were given to pt incase she has any worsening of sx, shortness of breath, chest pain, wheezing , difficulty breathing. She reported understanding.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,OTH,"Atorvastatin (LIPITOR) 10 mg Oral Tab Estradiol (ESTRACE) 0.01 % (0.1 mg/gram) Vagl Crea Cetirizine (ZyrTEC) 10 mg Oral Tab Afrin, oxymetazoline, 0.05 % Nasl Spray Montelukast (SINGULAIR) 10 mg Oral Tab Polymyxin B -Trimethoprim (",GERD,OA of joints,rash bilateral arms after Moderna first dose,"Hydrocodone-acetaminophen Codeine Cortisone Fosamax [Alendronate]Other. Latex Morphine Sulfa (Sulfonamide Antibiotics) Covid-19 Vaccine, Mrna-1273, Lnp-s (Moderna)Rash",['Headache'],2,MODERNA,IM 1049405,,59.0,M,Body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/31/2021,1.0,UNK,,,,,,['Pain'],UNK,MODERNA,IM 1049406,FL,86.0,F,Patient rcvd 1st covid 19 vaccine on 1/26/2021. Patient had house guests on 1/30/21. Those house guests tested positive for covid on 2/1/2021. Patient started getting symptoms on 02/2/2021. Patient tested postivie on 2/4/2021. Patient was hospitalized 2/7/2021. Patient passed away on 2/21/21.,Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,N,01/26/2021,02/21/2021,26.0,PHM,unknown,unknown,unknown,,none listed,"['COVID-19', 'Death', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1049407,OK,29.0,F,"Sore arm, severe body aches and pains, chills, fever. Sore arm was immediately, body aches started about 9 hours after vaccine was given. Chills started next morning, and fever started around 10:30 AM on 2/23/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/23/2021,22.0,WRK,Allegra Advair Albuterol Effexor Tylenol,None,Asthma Anxiety Allergies,,,"['Chills', 'Pain', 'Pain in extremity', 'Pyrexia']",1,MODERNA,SYR 1049408,CO,37.0,F,"Started having reaction on both elbows. Started as pain, then redness then itching. There after reaction moved to neck, with hives that were extremely itchy. Then after, hives were all over body. Lip started swelling, hands were very swollen, red, itchy. Was treated in ED with prednisone, antihistamine, Benadryl, and Pepcid. Went to see allergist after PCP appt due to 2 ER visits. They prescribed more medications. Meds in the morning were: Prednisone 40mg, Zyrtec 10mg, Pepcid 20mg, and Benadryl 50mg. Meds in the evening were: Zyrtec 10mg, Pepcid 20mg, Benadryl 50mg and Singular 10mg.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,02/05/2021,14.0,PVT,"Started taking Spironolactone 2 days after receiving injection, was taking Colace as well. Have been taking Phentermine for 3 months prior to vaccine.",None,None,,"Minocycline, codeine","['Arthralgia', 'Erythema', 'Lip swelling', 'Peripheral swelling', 'Pruritus', 'Urticaria']",2,MODERNA,IM 1049409,PA,70.0,F,"Within 1/2 hr. of receiving the vaccine, the left side of my face went tingling/numb. By evening it became very painful. Pain running from behind my left ear over my left checks, including upper and lower jaw on left side. By morning, I had blisters on top of my palate and part of my throat and in my sinus'. Pain became increasingly worse over next few days. Now on medication for it. I am hesitant to receive the second shot as I don't want to go through this again. Please advise.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/15/2021,0.0,SCH,"Losartan 50 mg, b.i.d.; Amlidopiline 12.5 mg., x/1 day; Hydrochlorothiazide 12.5 mg x/1 day; Spirolactine 25 mg. x/1 day. Vit. D3 2000 mg. ; baby aspirin 81. mg x1/day.",None,"Lower back pain & high blood pressure, obesity",,Ceftin,"['Facial pain', 'Hypoaesthesia', 'Oral mucosal blistering', 'Pain in jaw', 'Paraesthesia']",2,MODERNA,SYR 1049410,KY,72.0,F,1st vaccine 1/30/21; 2nd vaccine 2/20/21; developed SOA 2/21/21; seen in ED for ongoing SOA 2/23/21,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/21/2021,1.0,PVT,,,multiple; see chart,,Iodinated diagnostic agents; amoxicillin; iodine,['Dyspnoea'],2,PFIZER\BIONTECH,IM 1049411,IL,,U,"CHILLS, DIZZINESS, WEAK, AND FATIGUE",Not Reported,,Not Reported,Not Reported,,Not Reported,,,,,OTH,,,,,,"['Asthenia', 'Chills', 'Dizziness', 'Fatigue']",1,MODERNA,IM 1049412,GA,38.0,M,Felt dizzy and light headed. Watch indicated heart rate climbing up to 172bpm momentarily and dropped back down to 120bpm.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PUB,,,,,,"['Dizziness', 'Heart rate increased']",1,PFIZER\BIONTECH,IM 1049413,GA,77.0,F,"Diarreah, cramping, nausea, hives",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/18/2021,3.0,UNK,"Synthroid, Nexium, astragalus, multi vitamin, gabapentin",,,,"Penicillin, shellfish, sulfa, Cipro, codeine","['Abdominal pain', 'Diarrhoea', 'Nausea', 'Urticaria']",UNK,MODERNA,IM 1049414,IL,80.0,F,"Rash at injection side, swelling, redness, fever, sore to touch Had prescription cream from derm for another skin issue, used on rash on 2-23-2021 Has taken tylenol with arthritis for pain as well as regular tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/23/2021,5.0,PUB,"Calcium, Vit D, Vit C, Vit B Naproxen Sodium Tylenol Arthritis Prescription Cream: Clobetaflo propionate ointment",,Double Masectomy and Lymph removal,"Covid 19 Moderna, 01-19-2021",,"['Injection site erythema', 'Injection site pain', 'Injection site rash', 'Injection site swelling', 'Pyrexia']",2,MODERNA,IM 1049415,,64.0,F,"Fever,chills,bodyaches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/31/2021,1.0,UNK,,,,,,"['Chills', 'Pain', 'Pyrexia']",UNK,MODERNA,IM 1049416,PA,40.0,F,FEVER OF 103 CHILLS SWEATS MIGRAINE WHOLE BODY ACHES LOSS OF TASTE,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PHM,"BEYAZ, CYMBOLTA, AJOVY, IMITREX, MAGNESIUM, MULTIVITAMIN, CO Q-10, VITAMIN C",,,,"CIPRO, TEQUIN, MACROBID, PROZAC, AUGMENTIN,","['Ageusia', 'Chills', 'Hyperhidrosis', 'Migraine', 'Pain', 'Pyrexia']",2,MODERNA,SYR 1049417,CA,28.0,F,"Patient received her first Moderna vaccine 1/25/21 at hospital. Today patient came in for Moderna vaccine #2 but was given a Pfizer vaccine instead. No adverse affects. Per Dr. recommendation, there is no need to get a third vaccine. This will complete her series.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,na,na,na,,na,"['No adverse event', 'Product substitution']",2,PFIZER\BIONTECH,IM 1049418,,51.0,F,"Sore arm, tired, extreme fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/23/2021,1.0,UNK,none,none,Diabetic,,none,"['Fatigue', 'Pain in extremity']",UNK,MODERNA, 1049419,FL,22.0,F,Large sore red area with redder ring around reaction with heat lasting more than 9 days at site of injection,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/15/2021,1.0,PHM,None,None,None,,None,"['Injection site erythema', 'Injection site pain', 'Injection site rash', 'Injection site warmth']",1,MODERNA,IM 1049420,MD,77.0,F,"Acute nontraumatic pain in neck, left side, and upper left extemity(shoulder). Acute left cervical lymphadenitis. Still have discomfort in shoulder blade, some swelling yet of lymph node. Tingling in two fingers on left arm, had swelling over same two knuckles but that has receded just have like my hand is asleep, more at night time. Fullness feeling inside of arm at bend, vein area. Injection site is high - about 1 1/2 fingers down. Have had no x-rays or tests. Went to Urgent Care - prescribed Predisone for 5 days - no help. Nec k, now, has less swelling. Mom",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/09/2021,02/10/2021,1.0,UNK,None over the counter. Shaklee viramins w iron Low dose aspirin,None,Gastric issues Some arthritis,,None,"['Arthralgia', 'Lymphadenitis', 'Neck pain', 'Paraesthesia', 'Peripheral swelling']",1,MODERNA,IM 1049421,IL,58.0,M,"HEADACHES, CHILLS, FEVER, PAIN IN ARM, AND FATIGUE",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/18/2021,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 1049422,FL,62.0,F,"Within 1-2 minutes, felt like an infusion or flush with a chemical/metallic smell, taste. Extreme weakness, dizziness. Had to sit down for a long time, couldn't really open my eyes. Bad head feeling. Eyes hurt, but were not swollen. No swelling, just that constant metallic overwhelming. Dizzy. Stayed at pharmacy for about 40 minutes. On drive home, hot face, metallic infusion, very warm. Fever at home, achy all over, 99.8, very dizzy, brain fog, very weak, arm sore. Next morning, no better. Took a Nexium and immediately big hive popped up on my chest. Disappeared about an hour later. Took 3 days to feel like myself. Still concerned about allergic reaction. I'm a little itchy, tingly. I'm now terrified of getting that second shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PHM,"Synthroid 125 mcg that morning, that's it Nexium OTC 20mg daily -- had not taken pre-vaccination Advil 200 mg as needed (but not that day)",,COPD Carotid Artery Disease Hypothyroidism Reflux Hi-risk for colon cancer,,"Tylenol allergy - tingling, mild swelling lips -- started 5 years ago. Prior to that, no issues with Tylenol. Mango, eggplant Facial Hives for no obvious reason sometimes Strong reaction to some antibiotics, not sure if allergy related **Years ago. prior history of anaphylactic reaction (teenage years) no reason **No issues with Miralax taken for multiple colonoscopies","['Asthenia', 'Dizziness', 'Dysgeusia', 'Eye pain', 'Feeling abnormal', 'Feeling hot', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Parosmia', 'Pruritus', 'Pyrexia', 'Urticaria']",1,MODERNA,IM 1049423,IN,79.0,M,"Slight fever 99.6 degrees, joint soreness throughout the body",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/23/2021,1.0,PVT,"5mg Finasteride daily, ABC Plus senior multi vitamin, Ultra Cee 500mg daily, Slo Niacin2000mg daily, Vitamin D3 5000 IU daily, Diclofenac Sodium 1% gel daily",none,none,,none,"['Arthralgia', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1049425,NY,33.0,F,I had a shingles outbreak on my abdomen lasted 14 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/01/2021,4.0,PVT,No,No,No,,Secor? Kiwi (mild),['Herpes zoster'],1,MODERNA,IM 1049427,MA,31.0,F,"Vaccine #1: Supraclavicular lymph node swollen couple of hours after injection. 8 Hours after vaccine, chills, body ache, stiffness of left arm, and fatigue. Itchy rash around injection site 8 days later. Vaccine #2: 8- 10 hours after injection, chills, body ache, stiffness of left arm, headache, fatigue, and fever (100-101.5 degrees). 24 hours later, Swollen lymph node, fever, chills headache, and fatigue. Rash around the injection site3 days later. 6 days later, swollen lymph node (slightly reduced)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,MIL,,No,No,,"Nickel , Fragrance, Benzoyl peroxide","['Chills', 'Fatigue', 'Headache', 'Injection site pruritus', 'Injection site rash', 'Joint stiffness', 'Lymphadenopathy', 'Pain', 'Pyrexia']",2,MODERNA,SYR 1049428,NH,70.0,F,"2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-graded x 2 with poor appetite and recent 6lb weight loss. 2/8/21-APRN updated regarding poor appetite and difficulty chewing as well as downgraded texture of diet. Also informed of increased s/s of discomfort and increased use of PRN Oxycodone for pain. 2/9/21- elevated temp 100.7. 2/9/21 Covid pcr test negative. 2/9/21-N.O.?s APRN BMP, Albumin and Pre-albumin Level in am. 2/11/21-elevated temp 100.4. Covid rapid test negative. 2/12/21- CBG recorded at 517 at 5:20 am. Resident also has an elevated temp of 100.9. Tylenol administered per order. Vital signs include resp 24, radial pulse 134, O2 sat 83%. Supplemental oxygen administered via nasal cannula. Head of bed elevated. DR. notified at time via telephone. Order given for sliding scale for CBG. Guardian updated regarding changes in residents condition, poor prognosis. Guardian requests Hospice eval and admit. Guardian requests comfort care no hospitalization, no IV's, no G-tubes, no labs etc, D/C of Palliative services. ARNP informed. 2/12/21 Acute Telehealth visit with APRN due to increased lethargy, elevated CBG?s despite poor appetite and insulin administration. Resident unresponsive to verbal and noxious stimuli at time of visit. N.O. Morphine sulfate 20mg/ml, give 2.5mg PO/SL Q4hr PRN pain/shortness of breath. 2/12/2021-Admitted to Hospice, Lethargic, diaphoretic, T 98.1 P 130's R 18 O2 high 80's to low 90's via O2 mask at 3L. 2/12/2021- Resident legs and arms noted to feel cool this afternoon, 02 sat was 97% with 02 on @ 3L with mask Noted resident with sob and increased pulse. Prn morphine 0.25ml sl. given with good effect. Resident was less restless and quiet in her bed. Checked on resident several times this shift for needs. Resident noted to not move in her bed @ 8:15pm and noted she was not breathing. Supervisor called and pronounced resident deceased.",Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/07/2021,10.0,SEN,Aspirin Tablet 81 MG daily; Calcium Citrate-Vitamin D Tablet 315-200 MG daily; Donepezil HCl Tablet Give 10 mg daily; glipiZIDE Tablet 5 MG daily; HydroCHLOROthiazide Tablet 25 MG daily; Latanoprost Emulsion 0.005 % Instill 1 drop in both e,"1/6/2021-Resident noted with increased irritability and increased signs/symptoms of discomfort. Followed by Palliative APRN. Labs ordered and Tylenol increased for pain management. 1/7 labs BUN 28mg/dl/Creatinine 0.53mg/dl. CBC unremarkable. 1/7/2021-1st Pfizer Covid-19 Vaccine dose given. 1/15/2021 Palliative APRN came to visit reviewed labs Valproic Acid level WNL. Hepatic Panel with Albumin low at 2.6g/dl. Plan of care discussed with Guardian. N.O. DNR/DNH, may have draws labs and treat with ABX if needed. 1/24/2021 Patient vomited large amount of undigested food. 1/28/2021 2nd Pfizer Covid-19 Vaccine dose given.","Hx Covid + June 4, 2020; HYPERLIPIDEMIA, UNSPECIFIED (E78.5); UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE; TYPE 2 DIABETES MELLITUS WITH HYPERGLYCEMIA (E11.65); ESSENTIAL (PRIMARY) HYPERTENSION (I10); glaucoma; UNSPECIFIED MOOD [AFFECTIVE] DISORDER (F39); HYPOKALEMIA (E87.6); GASTROESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS (K21.9); HYPERLIPIDEMIA, UNSPECIFIED (E78.5);",,Nylons,"['Blood albumin decreased', 'Blood creatinine normal', 'Blood glucose increased', 'Blood sodium increased', 'Blood urea increased', 'Body temperature increased', 'Carbon dioxide increased', 'Death', 'Decreased appetite', 'Discomfort', 'Dysphagia', 'Dyspnoea', 'Feeling cold', 'Heart rate increased', 'Hyperhidrosis', 'Lethargy', 'Mastication disorder', 'Peripheral coldness', 'Prealbumin', 'Respiratory arrest', 'Restlessness', 'SARS-CoV-2 test negative', 'Unresponsive to stimuli', 'Vomiting', 'Weight decreased']",2,PFIZER\BIONTECH,IM 1049429,IL,52.0,U,"HEADACHE, CHILLS, FEVER, DIARRHEA, AND FATIGUE",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/22/2021,1.0,OTH,,,,,,"['Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Pyrexia']",1,MODERNA,IM 1049430,MS,63.0,F,Round light red circle at injection site. Sore to the touch and warm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/23/2021,1.0,MIL,,,,,Bee/wasp sting,"['Injection site erythema', 'Injection site pain', 'Injection site rash', 'Injection site warmth']",1,MODERNA, 1049431,TX,71.0,F,4 inch diameter itchy rash for about 2 weeks.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/12/2021,2.0,OTH,"Atenolol, levothyroxine, paroxetine, edarbyclor, B12, multi,",,,Pneumococcal,"Sulfa, codine, ether",['Rash pruritic'],1,MODERNA,SYR 1049432,NJ,61.0,M,"right parietal stroke--transient left-sided hemiplegia, dysarthia, agnosia, denial",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/04/2021,02/05/2021,1.0,OTH,"Allegra, Prilosec, Pepcid, ibuprofen, baby aspirin, Vitamin D, Trileptal (trigeminal neuralgia), Valsartan, Singular, pravachol, Zetia",see Item 12,"HTN, hypercholesterolemia, GERD, mild asthma, s/p mitral valve repair, asymptomatic minimal coronary artery disease detected at routine cardiac cath (prior to valve surgery)",,non known,"['Agnosia', 'Angiogram', 'Arteriogram carotid', 'Cerebrovascular accident', 'Coagulation test', 'Computerised tomogram head', 'Dysarthria', 'Echocardiogram', 'Full blood count', 'Hemiplegia', 'Laboratory test', 'Magnetic resonance imaging brain abnormal']",2,MODERNA,IM 1049433,SC,75.0,F,"The next day after shot I was very dizzy. Fell on floor going to bathroom. Ears and nose appeared stuffed up. I have only been out of bed 2 days since getting this shot 3 weeks ago. I have tried decongestants, Meclizine for dizziness., Levofloxacin and azithromycin for possible sinus infection..",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,OTH,"Morning meds, atenolol, aciphex, welchol, amlodipine","slight stuffy nose, no other symptoms","asthma. sarcoidosos. allergies, high blood pressure",,"Allergic to prednisone, penicillin, Xopenex","['Dizziness', 'Ear congestion', 'Fall', 'Nasal congestion']",1,MODERNA,SYR 1049434,CA,54.0,F,"burning tonge, oral mucosa burning few hours after vaccine dose #1, much milder after vaccine dose #2",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/16/2021,01/16/2021,0.0,PVT,"famotidine, alvesco inhaler, albuterol as needed, rizatriptan as needed",no acute illness during this period,"asthma, psoriasis, gerd retinal migraine, obesity",,"iodine, milk, neomycin, PCN, Sulfa","['Oral discomfort', 'Tongue discomfort']",1,PFIZER\BIONTECH,IM 1049435,NC,19.0,F,"Patient complained about chest tightness 15 minutes after vaccination, with no breathing problems. Asked patient to sit by me so that I could observe her. Checked blood pressure and was elevated. Administered Benadryl 50 mg one time by mouth to patient. Checked patient blood pressure a 2nd time and was 138/88 mmHg and patient was starting to feel a little wheezy. Decided that since patient seemed to be having an asthmatic episode that we would call EMS to pick her up and they arrived.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,OTH,"Albuterol inhaler, nebulized albuterol treatments",Asthma,Asthma,,"Cat dander, Cockroaches","['Asthma', 'Blood pressure increased', 'Chest discomfort', 'Wheezing']",2,MODERNA,IM 1049436,NY,59.0,F,"Chills, fatigue, body aches, no appetite Treated with Advil",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/23/2021,1.0,WRK,Daily vitamin Lexapro 5mg,,history of autoimmune problems Ulcerative colitis at age 18-21 surgery to create norms to my at age 21,"Age 57 had fever, headache, body ache after Shingrix accine",,"['Chills', 'Decreased appetite', 'Fatigue', 'Pain']",UNK,PFIZER\BIONTECH,IM 1049437,MI,43.0,F,Generalized pruritis a few minutes following 2nd dose of Pfizer COVID vaccine; reported having throat fullness for 2 weeks following first dose of vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,WRK,None known,None known,None known,,None known or recorded,"['Oropharyngeal discomfort', 'Pruritus']",UNK,PFIZER\BIONTECH, 1049438,VA,85.0,M,"While administering vaccine with a 1mm vanish point syringe, the needlee retracted after the plunger had been depressed at least half way, but prior to administering the full volume of the dose. A small amount of liquid was then observed running down the skin around the vaccination site.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/23/2021,02/23/2021,0.0,PUB,,,,,,['Underdose'],2,PFIZER\BIONTECH,IM 1049439,IN,72.0,F,"delirium, diarrhea On 02/13/2021 pt entered physician office for incorrect appt date and found to disoriented. Transferred to Hospital. Pt had in-pt stay until 02/13/2021. Pt discharged to son's care as she was unable to care for herself indepently. As of 02/23/2021 pt has still not returned to baseline.",Not Reported,,Not Reported,Yes,1.0,Yes,N,02/08/2021,02/12/2021,4.0,UNK,Quinapril 40mg Creon 6k units bid Synthroid 112 mcg Hctz 12.5 mg Lantus 22 u Humalong Amlodipine 5 mg Atenolol 50 mg Statin 20 mg Bupropion xl 150 mg Buspar Prolial injection every 6 months Donepezil,none,"Hx of breast and pancreatic cancer, diabetes, hypothyroidism, hypertension, depression, hyperlipidemia",,none,"['Computerised tomogram head normal', 'Culture urine negative', 'Delirium', 'Diarrhoea', 'Disorientation', 'Full blood count normal', 'Loss of personal independence in daily activities', 'Metabolic function test', 'Metabolic function test normal', 'Thyroid function test normal']",1,PFIZER\BIONTECH,IM 1049440,WI,85.0,M,"Muscle aches, weakness, loss of appetite, diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,,,COPD,,,"['Asthenia', 'Decreased appetite', 'Diarrhoea', 'Myalgia']",2,PFIZER\BIONTECH,IM 1049441,CA,52.0,F,"BODY ACHE, FATIGUE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,SEN,NONE,NONE,NONE,,NONE,"['Fatigue', 'Pain']",2,MODERNA,IM 1049442,CO,58.0,F,"Day 1 thru 7 lots of pain Felt like a brick hit arm. Day 7 thru 10 had a rash at injection site about the size of a hot pad, very itchy. I have an allergy to bee stings and I had the same reaction to vaccination as I do w/ bee stings except w/ the 7 day delay.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/17/2021,7.0,PVT,omneprozole,,osteoarthritis,,bee stings,"['Injection site pruritus', 'Injection site rash', 'Pain in extremity']",1,MODERNA,SYR 1049443,CA,65.0,F,"throbbing headache, nausea, dry heaves, sore arm, feels like she has flu, shoulder blades sore, coughing, headache goes to back of neck, thirsty",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PVT,"vitamins c,b complex, and zinc",,reactive asthma,,,"['Arthralgia', 'Cough', 'Headache', 'Influenza like illness', 'Nausea', 'Pain in extremity', 'Retching', 'Thirst']",1,MODERNA,IM 1049444,MA,28.0,F,"Pt stated she felt lightheaded. Denies SOB, chest pain. She stated that she did eat breakfast this morning and thought she may have been hungry and needed to eat lunch and she thought it may be indigestion. Gatorade and water given to pt and pt tolerated well. BP checked 120/80, HR 95. PT advised that if symptoms persist go to urgent care or to the closest PCP. PT verbalized understand and stated she felt fine to leave.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,SCH,unknown,unknown,"hypertension, hyperthyroidism",,unknown,"['Dizziness', 'Dyspepsia']",1,PFIZER\BIONTECH,IM 1049445,WI,89.0,M,"Hospitalized w/Covid symptoms 5 days. Shortness of breath, fatigue , bad taste in back of throat still exist today 02/23/2021",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,01/08/2021,01/09/2021,1.0,PVT,,"Gout, Covid19","CHF, A-Fib",,,"['Blood test', 'Dysgeusia', 'Dyspnoea', 'Fatigue', 'X-ray']",UNK,MODERNA, 1049446,IL,72.0,F,"Injection site became hot, red, itchy, and slightly swollen 2 weeks after the injection was administered..",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/19/2021,11.0,PVT,metropol,none,none,,sulfa,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 1049447,OR,55.0,M,generalized hives followed by generalized eczematoid rash with intense pruritis. One 2 cm cluster of small vesicles right lower pre-tibial area.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/22/2021,3.0,PVT,"atorvastatin, levothyroxine",none,"hypercholesterolemia, seasonal allergies, Rosacea",,pollen,"['Eczema', 'Rash pruritic', 'Rash vesicular', 'Urticaria']",2,MODERNA,IM 1049448,FL,74.0,F,"Constriction/ contraction of throat, then eyes and head and then chest. Felt like I was having a heart attack with feeling of great pressure on chest. Last a little over an hour.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,UNK,Blood pressure and cholesterol drugs,,Stage 3 kidney disease/ high blood pressure,,Sensitivity to epinephrine,"['Chest discomfort', 'Throat tightness']",2,MODERNA,SYR 1049449,AZ,41.0,F,"Started with achiness just before midnight (after having sore arm all day, but not troubling), woke with fever/chills/headache about 1am and unable to sleep well 1-6am, slight nausea 4-8am, still ongoing achiness all over body and just ill-feeling and fatigue (currently 11am day-after vaccine)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,OTH,"Synthroid, birth control, Wellbutrin",none,none,,none,"['Chills', 'Fatigue', 'Headache', 'Malaise', 'Nausea', 'Pain', 'Pyrexia', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 1049450,FL,40.0,F,Developed right lower quadrant pain over 3 days (02/9-11) which improved. Symptoms returned on 2/17. Went to emergency room on 2/18.,Not Reported,,Yes,Yes,2.0,Not Reported,Y,02/04/2021,02/09/2021,5.0,PVT,"Propranolol, Sprintec, Nortriptyline",,"Hypothyroidism, TMJ",,,"['Abdominal pain lower', 'Appendicectomy', 'Appendicitis', 'Computerised tomogram abdomen abnormal']",2,MODERNA,IM 1049451,CA,59.0,M,"Onset of temp 100.7 at 9pm on 2/20/2021 with rapid chills, body aches and headache within 1/2 hour. Continues throughout night with peak temp 101.6. Subsided in am 2-21-2021. Zero appetite for 2-21 and 2-22 with general malaise noted both days. Noted tiring by days end into Tuesday 2-23-2021. No residual symptoms noted except lack of appetite and being tired. I did not have the vaccine card with me at the time I completed this form. This was with Employee Clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,OTH,"Cardiaziem DILT-XR 120mg BID, ASA 325mg QD For A-Fib (20+ years)",None,A-Fib,,"Penicillin, Bee Stings - Anaphylaxis","['Chills', 'Decreased appetite', 'Headache', 'Malaise', 'Pain', 'Pyrexia']",2,MODERNA,IM 1049452,MN,74.0,F,"Moderna COVID-19 Vaccine EUA Swellling, redness, hot, pain at injection site on 02-21-2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/14/2021,02/21/2021,7.0,PVT,"Sotalol, Cartia, Norco, Xarelto",None,"Controlled a-fib, high blood pressure, arthritis",,"Rhythmol, Flecanoid","['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 1049453,AR,72.0,F,"Patient immediately after vaccine reported anxiety and difficulty talking. Patient took dose of children's Benadryl from home. States she has had this feeling before when exposed to chemical smells. After 10 minutes patient states symptoms are improving. Encouraged to stay for monitoring for additional 30 minutes. After around 5 minutes, the patient notified staff of symptoms reoccuring and worsening. States she is having shortness of breath, chest tightness and difficulty talking. Patietn evaluated and taken to ED for further treatment. Clinic provider notified.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,PVT,,,,,,"['Anxiety', 'Chest discomfort', 'Communication disorder', 'Dyspnoea', 'Immediate post-injection reaction']",2,PFIZER\BIONTECH,IM 1049454,WV,34.0,F,"1/1 vaccination 1/2 Extremely nauseous, vomiting, diarrhea. It felt as though severe pain where kidneys were but it ended up being debilitating back pain; had to miss work. Symptoms lasted for 3 days. My back pain lasted for about a week. Vomiting was for 3 days. I did seek medical attention; zofran and flexeril. *urgent care **not taking 2nd vaccination. Personal preference. 'Not worth it to go thru that again'.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/02/2021,1.0,PVT,wellbutrin,,Hepatitis C,,Sulfa,"['Back pain', 'Blood test', 'Computerised tomogram', 'Diarrhoea', 'Impaired work ability', 'Magnetic resonance imaging', 'Nausea', 'Urine analysis', 'Vomiting']",1,PFIZER\BIONTECH,SYR 1049455,FL,70.0,M,"12 hours after injection: Chills, Night sweats, Muscular ache chest up, fatigue, morning temp 101.8 Side effects dissipated/gone almost 48 hours after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PHM,"Atorvastatin 40mg Irbesartan 150 mg Vitamin C, D3, Zinc",None,None,,Lisinopril,"['Chills', 'Fatigue', 'Myalgia', 'Night sweats']",2,MODERNA,SYR 1049456,WI,69.0,F,"Fatigue, headache, diarrhea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,,,,,,"['Diarrhoea', 'Fatigue', 'Headache']",2,PFIZER\BIONTECH,IM 1049457,NY,76.0,F,"Upper arm around injection site, 2-3 inch radius, erythema, pruritus, raised rash somewhat rough to the touch. Benadryl at night to treat symptoms, helped with pruritus overnight. Rash lasted about 10 days, pruritus lasted 2-3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,02/04/2021,9.0,PHM,ALPRAZOLAM 0.25MG LIPITOR 10MG,,HYPERCHOLESTEROLEMIA,,SULFA CEPHALEXIN,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Rash papular']",1,MODERNA,IM 1049458,ND,82.0,M,Patient was popsitive for COVID19 on 12/16/20. Patient received Monoclonal antibody treatment at healthcare clinic on 12/17/20. Patient received first COVID vaccine at the healthcare clinic on 01/27/21 and is now due for his second does on 02/24/21.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,PVT,"Medications Prior Authorizations Control Gel Formula Dressing (DUODERM CGF EXTRA THIN) MISC USE AS DIRECTED CHANGE EVERY 2 TO 3 DAYS DUODERM EXTRA THIN 4"" X 4"" nitroglycerin (NITROSTAT) 0.4 mg sublingual tablet DISSOLVE 1 TABLET UNDER TO","Problem List Collapse by Default Collapse by Default Ulcerative colitis without complications (HCC) Hypothyroidism S/P CABG x 2 Coronary artery disease involving coronary bypass graft of native heart without angina pectoris Hypertension Hyperlipidemia Colon cancer (HCC) COPD (chronic obstructive pulmonary disease) (HCC) Type 2 diabetes mellitus with foot ulcer, without long-term current use of insulin (HCC) Seborrheic keratoses Bradycardia Chronic diarrhea Squamous cell carcinoma Diabetic ulcer of toe associated with type 2 diabetes mellitus (HCC) Impairment of cognitive function Nuclear sclerotic cataract of both eyes Bilateral exudative age-related macular degeneration (HCC) Bullous pemphigoid B12 deficiency COVID-19 virus infection Stage 2 chronic kidney disease","Problem List Collapse by Default Collapse by Default Ulcerative colitis without complications (HCC) Hypothyroidism S/P CABG x 2 Coronary artery disease involving coronary bypass graft of native heart without angina pectoris Hypertension Hyperlipidemia Colon cancer (HCC) COPD (chronic obstructive pulmonary disease) (HCC) Type 2 diabetes mellitus with foot ulcer, without long-term current use of insulin (HCC) Seborrheic keratoses Bradycardia Chronic diarrhea Squamous cell carcinoma Diabetic ulcer of toe associated with type 2 diabetes mellitus (HCC) Impairment of cognitive function Nuclear sclerotic cataract of both eyes Bilateral exudative age-related macular degeneration (HCC) Bullous pemphigoid B12 deficiency COVID-19 virus infection Stage 2 chronic kidney disease",,no known allergies,['Unevaluable event'],6,MODERNA,IM 1049459,NH,75.0,M,"Diarrhea, nausea, vomit, fatigue, dehydration, gastric pain Emergency room advised by primary care, received 1 liter IV saline Blood draw and CT scan all negative",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,PUB,lisinopril Atorvastatin Vit D,None,None,,Seasonal IV Contrast Dye,"['Abdominal pain upper', 'Blood test', 'Computerised tomogram', 'Dehydration', 'Diarrhoea', 'Fatigue', 'Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH,SYR 1049460,MD,87.0,F,"first vax. started to hurt 2 weeks after. site hurts, shoulder hurts. tylenol doesnt help. had 2nd vax today on other arm. three weeks today. Right arm still hurts. Doctor doesn't know why, or what to do.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/16/2021,14.0,OTH,too manty to list,"diabetes, copd, heart disease, spinal stenosis",see above,,codeine,['Injection site pain'],2,PFIZER\BIONTECH,SYR 1049462,,19.0,F,"Woke up the next morning with the most intense body aches to where I could not stand up. Vomiting continuously for 3 hours, eventually vomiting bile. Never had a fever. Took tylenol to help with the pain, as soon as it set in I fell asleep for about 3 hours. When I woke up I felt almost completely normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,UNK,"Synthroid, Prednisone, Hydroxychloroquine, birth control",,autoimmune disease,,allergic to sulfa drugs,"['Dysstasia', 'Pain', 'Vomiting']",2,PFIZER\BIONTECH,SYR 1049463,PR,53.0,F,Foggy vision and irritation in the eye for 5 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/15/2020,12/15/2020,0.0,PVT,None.,None.,"Asma, HBP.",,Unknown,"['Eye irritation', 'Visual impairment']",1,PFIZER\BIONTECH,IM 1049464,VA,72.0,F,"injection site turned red, felt hot, and itched. I took Benadryl after the third day of these symptoms; I continued 2 Benadryl a day for the next 4 days and eventually the redness disappeared and 95% of the itching stopped - I still feel a tingle of itching every once in awhile.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/12/2021,10.0,OTH,EZETIMIBE-SIMVASTATIN (10 MG) LOSARTIN (25 MG) LETROZOLE (2.5 MG) VITAMIN D,none,high blood pressure; high cholesterol; Chron's disease in remission; breast cancer in 2016-successful surgery,,drugs containing Sulphur,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 1049465,CA,18.0,F,"Dizziness, hypotension. resolved quickly.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,"Got HPV vaccine 4 days prior. On prozac, lamictal, adderall",,,,none,"['Dizziness', 'Hypotension']",UNK,PFIZER\BIONTECH, 1049466,OR,57.0,M,"rash hive-like on torso and upper and lower extremities bilaterally, sparing the face, palms and soles",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/13/2021,5.0,PVT,"tamsulosin, cannabis","aortic stenosis, benign prostatic hypertrophy","aortic stenosis, benign prostatic hypertrophy",,none,['Rash'],UNK,PFIZER\BIONTECH,IM 1049467,WV,37.0,F,"Fatigue, Sore arm for 3 days, swollen axillary lymph nodes, headaches",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/05/2021,4.0,SCH,None,None,None,,None,"['Fatigue', 'Headache', 'Lymphadenopathy', 'Pain in extremity']",1,MODERNA,IM 1049468,FL,70.0,F,"Flu like symptoms, nausea, diarrhea, headache, body aches, fatigue. Today is the fourth day of these reactions.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,PHM,Nitrofurantoin Mono-MCR 100 MG for a UTI; Escitalopram 20 mg Alprazolam 2 mg,"I was diagnosed with a UTI on Thursday, 02/18/2021, but was told to get the vaccination as long as I did not have a fever.","Bladder Cancer, osteoporosis, panic attacks",,None,"['Diarrhoea', 'Fatigue', 'Headache', 'Influenza like illness', 'Nausea', 'Pain']",2,MODERNA,SYR 1049469,SC,53.0,M,patient complained of diarrhea and dizziness on 2/20/21 that resolved on 2/22/21,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PVT,Abilify Maintenna 400 mg IM q 4 weeks Cogentin 1 mg BID Cozaar 100 mg qd HCTZ 25 mg qd Vitamin D 2000 iu qd,no active complaints,delusional d/o hypertension constipation pericardial cyst mesenteric mass GERD h/o TB h/o COVID-19 Psoriatic dermatitis h/o fever of unknown origin,,NKDA,"['Diarrhoea', 'Dizziness']",UNK,PFIZER\BIONTECH,IM 1049470,WI,70.0,F,"""Covid Arm""- Delayed reaction at injection site 10 days after injection. 3 to 4 inch circumference red, irritated and itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/23/2021,10.0,PHM,"Multi-Vitamin, Calcium +D, Fish Oil, Famoditine, B-Complex",None,,"Shingrix, fever, body aches, fatigue lasted one day",Allergie to Beeswax,"['Injection site erythema', 'Injection site irritation', 'Injection site pruritus', 'Type IV hypersensitivity reaction']",1,MODERNA,SYR 1049472,HI,59.0,F,Frozen shoulder pain is ongoing. Reduced range of movement in left arm along with pain when moving arm in certain ways.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/03/2021,1.0,PUB,None,None,None,,None,"['Joint range of motion decreased', 'Pain', 'Periarthritis']",1,MODERNA,SYR 1049473,MI,75.0,F,Tongue swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,UNK,"Benadryl, Prednisone",AngioEdema,Angio Edema,,Idiopathic - chemicals,['Swollen tongue'],UNK,MODERNA, 1049474,OK,35.0,F,Approx 5 minutes after receiving the vaccine she started getting blurry vision. She says the next thing she knew she was lying on the floor and there were 2-3 people standing around her. She has a swollen lymph gland under her left arm. feels fine now. Dr gave her promethazine RX to take prior to her next dose.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,OTH,none,NONE,NONE,,NKDA,"['Loss of consciousness', 'Lymphadenopathy', 'Vision blurred']",1,PFIZER\BIONTECH,IM 1049475,CT,68.0,F,"BP 180/100 , repeat 170/90 Pulse Ox 96 While sitting in observation pt reported having an itchy area on her left wrist. Pt reported a history of CT Scan Contrast Dye and seasonal allergies. Pt was evaluated by EMS paramedic. Pt declined transport to the ED despite recommendation and education on precursor to anaphylaxis. Pt signed refusal with EMS. Pt reported she often gets itchy for no apparent reason. Pt stayed at clinic in observation for over 45 minutes with no progression of itchiness or other symptoms. . Pt was given ED precautions.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PUB,Unable to review in VAMS,Unknown,Pt reports history of getting itchy all over her body but without rash. Pt reports she is not sure why this happens.,,CT scan dye and seasonal allergies,"['Blood pressure increased', 'Pruritus']",1,MODERNA,IM 1049476,NE,52.0,M,"I developed ED and still have it 3 weeks later. Can you let me know if this is permanent? or temporary? Also, You should let other sexually active males of this risk.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/03/2021,2.0,UNK,None,None,None,,"Sulfa antibiotics, Penicillin",['Erectile dysfunction'],UNK,MODERNA,IM 1049477,CA,66.0,F,"Headache in about 20 minutes after Vaccination. Next day had headache and diarrhea and by 3rd day has vomiting, chill and weakness which lasted 6 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,OTH,20. different prescriptions,None,"Diabetic, Asthma, High Blood Pressure",,21 different medication in addition to Cats and dogs,"['Asthenia', 'Chills', 'Diarrhoea', 'Headache', 'SARS-CoV-2 test negative', 'Vomiting']",1,PFIZER\BIONTECH,SYR 1049478,MN,46.0,M,"Fever, aches, chills, migraine, nausea . No treatment other than fever reducing medication. All resolved after 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,UNK,Flonase Emergen-C 1000 mg Vitamin C,none,Asthma,,Sulfa,"['Chills', 'Migraine', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,IM 1049479,WA,45.0,F,"9th, in the late afternoon, I started feeling really cold and I started getting headache and a lot of arm pain. It hurt to reach out to grab steering wheel. I felt very tired. I checked my temperature - 100.5. I got really cold and shivering at about 6:00 pm and I could not warm up for about 2 hours. It went to 101.5. Horrible pounding headache and dizziness. I started having stomach issues and diarrhea but didn't vomit. That went through the night - I felt like I had the flu. Back of my neck was really stiff and achy - from shoulders up to the back of my skull. I didn't sleep much. I woke up completely soaked in the morning. My fever had broken. SUnday, I felt a little better. Dull headache ( it came and went). My temperature would go up and down -96.8 - to 100.1-ish all day. When my temp went up I got a headache and fatigue and down my headache would be better. Rolling every four hours. Monday, I stayed at 99.2 to about 100.2. Stayed at that the whole day. I was really tired. I had trouble thinking and concentrating. My arm was feeling better by Monday. Monday afternoon, about 1:00 my fever went to 100.5 and I called the nurse then. She told me to call my doctor's office. They sent me to a call to a triage nurse and she advised me to get tested for COVID. So Tuesday morning, the 12th,at 9:00 am - healthcare clinic - the results were negative for COVID. Tuesday, I was feeling a little better - fever stayed around 99.2 to just over 100 and the headache was dull. I wasn't quite as tired. Wednesday, I was feeling better - like I could go to work but I didn't because of my fever the day before. I went to work on Thursday or Friday. The whole next week then I was better and felt fine. I got the second dose February 1.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,PVT,daily zyrtec - 10 mg; allergy shots (although I had taken time off before the vaccine),no,asthma; environmental allergies,"Tdap - I have gotten the ""dead"" arm before - so sore that I can't even lift it up. Some Tdap shots - last one that I got this di",egg sensitivity milk allergy an antibiotic - unknown at this time - hives,"['Chills', 'Diarrhoea', 'Disturbance in attention', 'Dizziness', 'Fatigue', 'Feeling cold', 'Headache', 'Influenza like illness', 'Musculoskeletal stiffness', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,SYR 1049480,MA,48.0,F,"Day 1- Hives about 5 hours after injection, lasted a few hours, soreness at injection site Day 4- welt and redness at injection site, progressing daily Day 12- spreading redness and swollen at injection site, very hard. Visited PCP and received antibiotic",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/15/2021,4.0,PHM,"Biotin, Aspirin, Vitamin D, Elderberry with Vitamin C, Estrovera, Pantoprazole, Buspirone, Metoprolol",,"High Blood Pressure, Asthma",,"Amoxicillin, Contrast dye, Bactrim, Losinipril, Perococet","['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Urticaria']",1,MODERNA, 1049481,AL,38.0,F,"Large, swollen knot around the injection site on right arm, beginning the day after vaccine. The knot grew in size, bright red, and is warm to the touch on day 10 after the vaccine. The swollen area is about the size of a softball on day 10 and is painful. Entire right arm feels weak and aches, similar to growing pains.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,PVT,none,none,none,,none,"['Injection site erythema', 'Injection site mass', 'Injection site swelling', 'Injection site warmth', 'Muscular weakness', 'Pain in extremity']",1,MODERNA,SYR 1049482,NJ,33.0,F,"I received the vaccine on 02/11/21 and am breastfeeding my 7-month-old daughter. The next morning, my daughter had a rash throughout her stomach. The rash appeared to flare up after feedings. I stopped breastfeeding for 12 hours and the rash was resolved. She was seen at pediatrician for this issue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/12/2021,1.0,UNK,Prenatal vitamin,No,No,,,"['Exposure via breast milk', 'Rash']",UNK,PFIZER\BIONTECH, 1049483,CA,74.0,M,Headache Body Ache Fever (99.2),Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/23/2021,1.0,OTH,None,Diabetes Hypertension Thyroid,good,,None,"['Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1049484,PA,71.0,F,"Started with a red ring around injection site on left are. then on 2/14 red flat rash started forming on arms and legs. Rash was itchy and hot. went to Primacy Care Doctor 2/5/21, the to ER 2/16, and then finally the dermatologist on 2/16. At dermatologist they took a biopsy and gave pt. prednisone starting with 40 g with a 12 day tapered dosing.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/12/2021,8.0,PUB,Multi-vitamin,none,none,,bug bites,"['Injection site rash', 'Rash', 'Rash pruritic', 'SARS-CoV-2 test negative', 'Skin warm']",1,MODERNA,IM 1049486,NE,28.0,F,"Full body rash. Started at site of injection site woke up next morning with a completely full body red, itchy, bumpy rash. Went to dermatologist and they said it was from vaccine they prescribed me an external cream to take.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/23/2021,4.0,OTH,None,None,Asthma,,Allergy to zythromycin,"['Injection site rash', 'Rash', 'Rash erythematous', 'Rash papular', 'Rash pruritic']",2,MODERNA,SYR 1049487,PA,62.0,F,"Red face, swollen lips, itchy watery eyes, red rash over body",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,OTH,,none,graves disease,,"morphine, dilaudod, fentanyl, sulfa, eggs, penicillin","['Erythema', 'Eye pruritus', 'Lacrimation increased', 'Lip swelling', 'Rash erythematous']",1,MODERNA, 1049488,CA,43.0,M,"joint pain, light headed, muscle pain. Low energy. Headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/13/2021,1.0,UNK,"Meloxicam 7.5 Mg, Pantoprazole Sod 40 Mg, Sumatriptan 50 Mg, Baclofen 10 Mg, Duloxetine Hcl 30 Mg, Amlodipine Besylate 2.5 Mg, Losartan Pot 50 Mg, Aspirin 81 Mg",,BP,,seasonal,"['Arthralgia', 'Asthenia', 'Dizziness', 'Headache', 'Myalgia']",2,MODERNA,IM 1049489,WI,75.0,F,Next dayt bad taste in mouth. Then sore under tongue and sore roof of mouth similar to when you get injections for tooth extraction. Swelling of upper lip. Lasted about 1 week before gradually going partial away. It's 10 days and still minor pain on roof of mouth and most swelling of upper lip is gone.. Took Tylenol a few times. Did not contact doctor.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,PHM,100 mg Losartan 1 Daily PM 100 mg Metoprolol ER Succinate 1 Daily PM 2.5 mg Amlodipine Besylate 1 Daily PM 300 mg Bupropion XL 1 Daily PM 5 mg Oxbutynin 2 Daily PM 500 mg Amoxicillin 4 Pills1/2 Hour,None,"Obesity, Anxiety, High Blood Pressure",,None,"['Glossodynia', 'Lip swelling', 'Oral pain', 'Taste disorder']",1,MODERNA,IM 1049490,MD,81.0,F,"I had my first dose of the Moderna vaccine on Feb. 10, 2021. I had about three days of chills, aches, headache, very sore arm. etc. On Feb. 22,2021 a red area about 3 or 4 inches around the site of the injection was noticed. It was itchy and uncomfortable. I spoke to my internist and allergist. There is some disagreement about whether I should take the second dose. I have taken benadryl and tylenol. Both doctors said it was unusual for such a reaction 2 days after receiving the vaccine. What information do you have about rashes occurring so long after the vaccination? What is the recommendation about the second vaccine? Thank you.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/22/2021,12.0,PUB,lisinopryl anastrozole prolia cranberry supplement Vit D and Calcium supplement,none,mitral valve osteoporosis breast cancer,second shingrex vaccine,season allergies hazelnuts penicillin sulfa,"['Chills', 'Headache', 'Injection site erythema', 'Injection site pruritus', 'Pain', 'Pain in extremity']",1,MODERNA,IM 1049491,NM,32.0,M,"tremor, cough, chills, body aches, severe pain on both arms starting from 1am on 2/23. As of reporting still coughing and having a headache. tremor and chills resolved about 1 hr from symptom onset",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/23/2021,1.0,PHM,"omeprazole 20 mg,",NO,HIATAL HERNIA which causes acid reflux,,NKA,"['Chills', 'Cough', 'Pain', 'Pain in extremity', 'Tremor']",2,MODERNA,IM 1049492,CA,70.0,F,On the evening of the vaccine the headache started and arm was sore. But 9 out of the last 12 days I've had headaches and I don't normally have headaches.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/11/2021,0.0,OTH,"500mg Hydroxyurea once a day, Lorazepam, Aspirin",no,Mylo Proliferative Disorder,,none known,"['Headache', 'Pain in extremity']",1,MODERNA,IM 1049494,FL,72.0,M,"Soreness, rash & itching at shot site. Not resolved after 24 hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/22/2021,10.0,PHM,"Atorvasatin (zocor generic) 20 mg every other day, Centrum silver over 50, extra Vit .D, Glucosimine & Chondrotin, 81 mg Aspirin",mild gout,,,"Bactrim, Amox","['Injection site pain', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 1049495,TX,41.0,F,On 2/17/2021 presented with rash/lesions to torso minimally to extremities with no itching noted. Once the lesions dry they present in a darker hyperpigmentation color. Consulted with dermatologist on 2/22/21 was prescribed oral meds (Atarax) and topical steroid (Triamcinolone) to apply to lesions. Was not able to consult sooner due to increment weather and no open medical facilities to consult. 2/23/21 rash continues with no itching but redness has mildly improved.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/17/2021,12.0,PUB,Xyzal 25mg tab at bedtime daily,None,None,,None,"['Rash', 'Skin hyperpigmentation']",2,MODERNA,IM 1049496,OH,19.0,F,"Bells Pals half of face, numbness, weakness, headache, fever, diarrhea, nausea, chills, body aches, fatigue., tics and then a few days later had a gran mal seizure, forgetfulness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/23/2021,15.0,SEN,Allergy medicine,None,"ADHD, anxiety, tics",,"Zithromax, dogs, tree allergies","['Asthenia', 'Chills', 'Condition aggravated', 'Diarrhoea', 'Facial paralysis', 'Facial paresis', 'Fatigue', 'Generalised tonic-clonic seizure', 'Hypoaesthesia', 'Memory impairment', 'Nausea', 'Pain', 'Pyrexia', 'Tic']",2,PFIZER\BIONTECH, 1049497,MN,38.0,F,"Chills, low grade fever, runny nose, body aches, brain fog, mild headache, fatigue that lasted at least 24 hours. Brain fog lasted approximately 5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,OTH,None,None. Previously had Covid-19 the first week of December 2020.,Obesity. No other health conditions.,,Allergy to Sulfa drugs. Side effects from escitalopram and paxil. No other known food/drug allergies.,"['Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Pain', 'Pyrexia', 'Rhinorrhoea']",1,MODERNA,IM 1049498,OH,41.0,M,"After I went to bed, I started running a fever, had chills, and body aches. All my joints were sore the next day as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/23/2021,1.0,MIL,Daily multivitamin,None,None,,None known,"['Arthralgia', 'Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1049499,IL,59.0,M,SWOLLEN RIGHT LIP UPPER RIGHT SIDE PERIORBITAL BRUSING OF LEFT EYE,Not Reported,,Not Reported,Yes,1.0,Not Reported,,01/15/2021,01/23/2021,8.0,OTH,,,,,,"['Eye contusion', 'Lip swelling']",1,MODERNA,IM 1049500,NJ,43.0,F,"Covid Arm started yesterday (2/21/21) evening. Bright red circle, two finger width, hot and itchy. It has increased in size today (2/22/21). I did put Benadryl cream on it last night and today. Main complaints- Hot, itchy, hard to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/22/2021,7.0,PHM,Current Medications- Daily Use Singular 10 mg- (montelukast) take 1 pill at bedtime Plaquenil 200 mg-(hydroxychloroquine) take 1 pill daily Zoloft 50 mg (Sertraline) take 1 pill at bedtime Current OTC- Daily Use Allegra 180 mg-(fexofenadine,Vertigo,Sjogren's syndrome,,"Vicodin Trees, grass, dust mites, pollen","['Erythema', 'Induration', 'Pruritus', 'Skin warm']",1,MODERNA,SYR 1049501,,36.0,M,"Arm Soreness and stiffness, Headache (the patient took Tylenol)",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/21/2021,9.0,PVT,,,,,,"['Headache', 'Musculoskeletal stiffness', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 1049502,CA,74.0,M,Diagnosed with myasthenia gravis on 2/16/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,02/09/2021,18.0,PVT,Metformin Glipizide Hydrochlorothiazide Clonidine Carvedilol Losartan Atorvastatin,,DM2 HTN CAD Adult obstructive pulmonary disease,,Maxide nifedipine NSAIDS,"['Antiacetylcholine receptor antibody positive', 'Myasthenia gravis']",1,MODERNA,IM 1049503,WA,53.0,F,Shortly after the vaccine I developed chest tightness and SOB causing me to use my Albuterol Inhaler. Later that evening I took my reg asthma meds. Sat morning still experiencing the SOB but a bad headache appeared and had some stomach aches as well. 1/9 I spoke with my Allergist who advised to take an additional Singulair and Xyzal meds on top of what I was originally taking already. 1/10 was advised to take and Allergra for the SOB along with my reg meds that evening and by the Tuesday of the next week I was finally able to get my back Asthma balanced out.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,"Levothyroxine, Xyzal, Singulair, Pantoprazole, Prempro",no,"Asthma, Allergies","smallpox- childhood, unsure of the time or brand","bee stings, various foods and environmental thing, nuts, trees, grass, shellfish","['Abdominal pain upper', 'Asthma', 'Chest discomfort', 'Condition aggravated', 'Dyspnoea', 'Headache']",1,PFIZER\BIONTECH,IM 1049504,PR,27.0,M,"Two days after the administration, the patient started to feel headaches that lasted all the way through January 3, 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/16/2020,12/18/2020,2.0,PVT,None.,None.,None.,,None.,['Headache'],1,PFIZER\BIONTECH,IM 1049505,CA,69.0,M,extreme gut pain right behind my solar plexus. I had the shot on Saturday and Sunday morning I was in agony all day. It is Tuesday and it is still very much there,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/22/2021,2.0,PVT,xarelto and pepcid,,,,,"['Gastrointestinal pain', 'Pain']",1,MODERNA,IM 1049506,NY,73.0,F,"After 15 minutes of the vaccine she left and when she got home had an anaphylactic reaction, had to use her Epi-Pen. Did a telemed appointment with her physician who told her to take one dose of the Epi-Pen, Benadryl, Prednisone, Ventolin, and Singulair. These medications have worn off, and wants her to take even more doses of the Prednisone, Benadryl and the inhaler. She is still having symptoms, but improving. She does not itch as badly. Her arm is sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,PHM,"Januvia, Micronase, Diovan, Singulair.",None.,"Asthma, high blood pressure, allergies, diabetes type II.",,"Levaquin, Sulfa, Penicillin, aspirin, NSAIDS. All melons. Bee and wasp stings.","['Anaphylactic reaction', 'Pain in extremity', 'Pruritus']",1,PFIZER\BIONTECH,IM 1049507,CA,49.0,F,"Shortly after receiving the vaccine, diarrhea & fatigue developed. Continued x 2 days, then subsided on day 3.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,,,,,,"['Diarrhoea', 'Fatigue']",2,MODERNA,IM 1049508,GA,70.0,F,"Noticed redness and tenderness on 4 gums in mouth soon after shot, visited dentist who recommended salt water rinses, have been doing that for 5 days, somewhat better but not gone, dentist mentioned that he had seen a photo of something similar in the mouths of two men who tested positive for Covid.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/04/2021,2.0,PUB,"Losartan 100 mg, Verapimil 180mg, ibuprofin 400 mg",none,none,,none,"['Erythema', 'Gingival pain']",1,MODERNA,SYR 1049509,MN,64.0,F,(L) ear Hearing Loss: hearing loss occurred after both vaccinations. After Vaccination #1-1/28/2021: Hearing loss occurred on Friday 1/29/2021 about 0200-0300 then returned 100% by Saturday afternoon. Then after vaccination #2 - 2/19/2021: hearing loss occurred on Friday 0200-0300 as of 2/22/2021 hearing loss is approximately 90% returned.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/19/2021,1.0,SEN,Albuterol 90mcg 1 puff q4-6h prn; lactobacillus Acidophilllus 2 capsules qd; Lanolin/mineral oil topically prn; vag gel 1 application 2X/week; mometasone furoate 50mcg 2 sprays each nostril QD; pantoprazole Na 40 MG QAM; ranitidine hcl 150m,Sinus Headache.,unknown,,Zoledronic,['Deafness unilateral'],2,PFIZER\BIONTECH,IM 1049510,MA,55.0,F,"Sore arm, headache, dizzy, tired, chill. a little fever, from 6 hrs to 40 hrs after dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,WRK,None,None,None,,None,"['Dizziness', 'Fatigue', 'Feeling cold', 'Headache', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1049511,OH,62.0,F,"Afternoon of vaccine began chilling, body aches, fatigue, sore arm. Temp rose to 103.5. I alternated Tylenol with Motrin. Tylenol did little to decrease this fever, motrin seemed to bring it down for about and hour then would go back up again. Temp stayed between 102 to 103 through Sunday 2/21/21. Temp 99-101 on Monday 2/22/21. Today as I report, temp is 99 and continue to feel very fatigued with no energy and poor appetite.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PUB,Synthroid Lotrel ASA Lozol,none,"HTN, History of MI, Osteoarthritis, Hypothyroidism, Pre-Diabetes",,"Sulfa, Pineapples, Environmental","['Asthenia', 'Chills', 'Decreased appetite', 'Fatigue', 'Pain', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 1049512,MT,75.0,F,"headache, muscle aches, pain at injection site, sensitivity to touch--prickly skin, severe elbow and shoulder pain--both sides, insomnia, 100 degree fever approximately 18 hours after shot, treated successfully with acetominophen. Symptoms still present 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,PUB,"budesonide, triamterene, diltiazem, celebrex, atorvastatin, vitamins, calcium with D",none,"high blood pressure, osteoarthritis, microscopic colitis","shingrix: severe diarrhea, microscopic colitis","codeine, NSAIDS, stings","['Headache', 'Injection site pain', 'Insomnia', 'Myalgia', 'Pain in extremity', 'Paraesthesia', 'Pyrexia']",2,MODERNA,IM 1049513,AL,33.0,F,"There were no immediate adverse affects after the vaccine. Arm tenderness near the injection site became very noticeable the morning after the shot. About a day after the vaccine, I developed flu-like symptoms: joint tenderness, body aches, chills, and a low-grade fever of 99 - 100.1 degrees. These symptoms were completely gone within 48 hrs. I experienced moderate to severe arm tenderness for 3-4 days. I also had slight periods of itchiness near the site of injection, but again, this dissipated completely after 3-4 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/29/2021,1.0,SCH,"Zoloft, Klonopin",None,None,"After my 3rd shot for hepB (I was 18 at the time, I don't remember the vaccine brand or date, it was during the summer break), I",latex,"['Arthralgia', 'Chills', 'Influenza like illness', 'Injection site pain', 'Injection site pruritus', 'Pain', 'Pyrexia']",1,MODERNA,SYR 1049514,MI,73.0,M,"As listed in the v-Safe materials, ""A bad rash all over your body.""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,OTH,bisoprolol 5mg/day hydrochlorothiazide 25mg/day penicillin V potassium 500mg/day omeprazole 20mg/day vitamin D3 4000IU/day vitamin C 500mg/day probiotic 1time/day,None,Penicillin is for a knee replacement in 2015 that became infected. Markers for continued infection go up when penicillin is not taken.,,Asprin,"['Drug eruption', 'Rash']",UNK,MODERNA,SYR 1049515,PA,48.0,M,"developed slight eye tearing and left ear pressure within 24 hours of vaccination. followed by left facial drooped. was seen in ER on day 3 after vaccination, diagnosed with Bells Palsy. treated with eye care and oral prednisone.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,WRK,,,HTN,,,"['Borrelia test negative', 'Ear discomfort', 'Facial paralysis', 'Lacrimation increased']",1,MODERNA, 1049516,CT,69.0,F,"After vaccination the pt reported feeling light headed. Pt was evaluated by Prospect EMS paramedic. BP 140/100, HR 59. Pt reports allergies to Vicodin, Percocet, Dilaudid, Benzoyl Peroxide, Dramamine, Iodine, silk tape, and lanolin. Pt declined transport to the ED. Pt ate a snack and drank some water, she then reported feeling better.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PUB,N/A- not in VAMS,Not in VAMS and not indicated by patient,Not in VAMS and not indicated by patient,,"Patient reports allergies to Vicodin, Percocet, Dilaudid, Benzoyl Peroxide, Dramamine, Iodine, silk tape, and lanolin.",['Dizziness'],1,MODERNA,IM 1049517,MA,39.0,F,"The day after I received the 2nd Moderna vaccine I started to have intense internal vibrating/tremors. My BP is higher, pulse is higher, pupils are dilated. The internal vibration/tremor has not gone away for 4 weeks.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/25/2021,1.0,PVT,None,None,None,,None,"['Hypertension', 'Laboratory test', 'Mydriasis', 'Tremor']",2,MODERNA,IM 1049518,NY,51.0,F,"Left arm 1st dose given at 12:39 pm. 15 mins post vaccination, patient began having a warms sensation on her left shoulder blade followed by itching in her extremities. She was brought to observation and reported urticaria all over, flushing of the face, and hives in her upper and lower extremities. Vitals taken and were stable. Benadryl 50mg was administered 15 mins post vaccination and immediately patient reported decreasing symptoms of warmth sensation, itching, and hives. Patient reports she has recently developed hives with cortisone injections. Patient examined 20 mins post vaccination: S1,S2, CTA, hives noted on bilateral UE and LE. Hives resolved 25 mins post vaccination. Patient monitored for over 45mins and reported her symptoms were mild. She declined transportation to the ER. She left in stable condition with her husband.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,OTH,,,Pulmonary Hypertension COPD,,"All NSAIDs, Flygyl Bees Delarex","['Feeling hot', 'Flushing', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,IM 1049519,CA,43.0,U,"Light headedness, dizziness, fatigue, Chest pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,none,None,None,,"Sulfa, Hizentra, Hgvia","['Chest pain', 'Dizziness', 'Fatigue']",UNK,PFIZER\BIONTECH,IM 1049521,CA,69.0,F,"Large red area at injection site (left arm), itching & tenderness to touch, red rash in armpit with itching. For 2-3 days before the redness I noticed tenderness & itching at the injection site & armpit. Only other symptom is feeling very tired. I contacted my doctor & sent her photos. She agreed it was Covid arm & told me to contact this site & to let her know if I was getting better or not.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,OTH,"Levothyroxin, multivitamin, calcium, magnesium, Vit D, Vit K",,"Osteoporosis, hypothryroid",,"Penicillin, Septra","['Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Rash erythematous', 'Rash pruritic']",1,MODERNA,IM 1049522,GA,37.0,F,"Pt. received second dose of Moderna Covid 19 EUA vaccine at 3:15pm. At 3:31, pt stated she felt lightheaded/dizzy and could ""taste the vaccine"", which was making her anxious. Vitals @ 3:22 139/86, HR79, Resp 36, O2 97, temp 97.3. Patient given water. Vitals @3:37 119/81, HR80 O2 98. Patient reported feeling better, and taste was gone. Vitals @ 3:42 120/84 HR78 O2 98, resp 32. Patient then released with instructions to contact MD/ER should any symptoms recur. Patient expressed understanding.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,"Prilosec, Multivitamins",none,none,,none,"['Dizziness', 'Taste disorder']",2,MODERNA,IM 1049523,NJ,63.0,F,"Initially, just pain at the injection site but it was followed by a very large bruise which has lasted over a week. Yesterday, I noticed that the injection site area has a red rash all around it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/15/2021,1.0,PHM,"Lisinopril, Climara, desloratadine, Vitamin D, multivitamin, Metamucil",None,Hypertension,,"Latex, bacitracin, neosporin, chlorhexidine","['Injection site bruising', 'Injection site erythema', 'Injection site pain', 'Injection site rash']",UNK,MODERNA,IM 1049524,KY,77.0,M,1st vaccine 2/19/21; developed N/V/D abdominal pain and fatigue 2/20/21; seen in ED 2/23/21 for ongoing symptoms,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/20/2021,1.0,PVT,,,Multiple; see chart,,PCN,"['Abdominal pain', 'Fatigue']",1,PFIZER\BIONTECH,IM 1049525,PR,41.0,F,"10 minutes after the vaccine was administered, the patient started presenting a tingling sensation on her throat. She was given diphenhydramine 50 mg IM.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PHM,,,,,,['Pharyngeal paraesthesia'],1,MODERNA,IM 1049527,MD,71.0,F,FACIAL REDNESS TOOK ORAL BENADRYL AT HOME 1 HOUR LATER PT FELT IMPROVED,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,OTH,,NO,,,NO,['Erythema'],1,PFIZER\BIONTECH,IM 1049528,OH,41.0,F,"1/16 Vaccination. Later that evening at about 6:30, my arm was wicked sore. Naproxen and heating pad. Symptoms lasted for 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/16/2021,01/16/2021,0.0,OTH,miralax,,,,"adhesives, latex",['Pain in extremity'],1,MODERNA,SYR 1049529,WA,45.0,F,"About 11 hours after vaccine, my temperature went up to 101.5 - pounding headaches and dizzy. No digestive issues this time. My arm was very sore again - not quite as bad as first time. Body aches - general. I woke up drenched in sweat about 4 am in the morning - I went and took a shower and went back to bed. Tuesday, temperature was doing up and down - 100.5 or .6 down to 96.7. Normally I'm 97.2 or 97.4. My arm was sore. By Wednesday, I was feeling much better - 99.3 - 99.8 (may have not hit 100 degrees). My arm was sore but not as achy so it was better on Wednesday. By Thursday, I was feeling a lot better. It didn't last as long as first dose.. I was able to work after that.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,OTH,daily zyrtec - 10 mg; allergy shots - maybe the week before the vaccine,adverse health event after dose 1 of the Moderna vaccine,asthma; environmental allergies,"Dose 1 -Moderna COVID 19; Tdap - vaccine - arm ""deadness"" usually but not the last dose of the Tdap that I received. at age 16 -",egg sensitivity milk allergy an antibiotic - unknown at this time - hives,"['Dizziness', 'Headache', 'Hyperhidrosis', 'Pain', 'Pain in extremity', 'Pyrexia']",2,MODERNA,SYR 1049530,NJ,82.0,F,"For both the 1st and 2nd vaccination of moderna, an itchy red patch appeared on my right arm measuring approximately 2? x 3.5?. The red patch after the 1st shot appeared 5 days after the shot and lasted 5 days. For the 2nd shot on 2/20/21, the red patch appeared the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/30/2021,7.0,PVT,Diltiazem hcl er (tz)-180mg Digoxin 125 mg Centrum silver multi vitamin Vitamin D3-2000units Xaralto-15mg,None,Plynyalgia rheumatica Atrial fibrillation Left bundle branch block arorta value,,Sulphate Penicillin Mono sodium glutamate,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,SYR 1049531,IN,39.0,M,"19 Feb: Received vaccinate roughly 1330hrs. [1400hrs through 2100hrs] lightheaded, slight headache. [1500hrs onward] tightness in throat. 20 Feb: [All day] tightness in throat; fatigue; glands swollen in jaw/neck; joint pain in shoulders and ankles. 21 Feb: [All day] tightness in throat; fatigue; glands swollen in jaw/neck; joint pain in shoulders, lower spine, and ankles. 22 Feb: [as of 1100hrs] tightness in throat; fatigue; glandes swollen in jaw/neck; joint pain in shoulders and ankles. Takes benadryl to alleviate sysmptoms, declines advise for further care.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,MIL,Dietary Supplment: One a day mens,None,None,,Penicillin,"['Arthralgia', 'Dizziness', 'Fatigue', 'Headache', 'Lymphadenopathy', 'Throat tightness']",1,MODERNA,IM 1049532,CO,62.0,F,Patient reported Red raised itchy area around the site of injection 10 days post vaccination. Consulted with PCP was given go ahead for second dose. Irritated area resolved in 5 days with no treatment.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/29/2021,10.0,PUB,Unknown,None,Auto immune condition. Did not want to let Nurse know of specific condition. Patient spoke with PCP about receiving the vaccine and was encouraged to get vaccinated in consideration of patient condition.,,None,"['Injection site erythema', 'Injection site irritation', 'Injection site pruritus', 'Injection site urticaria']",1,MODERNA,IM 1049533,NH,75.0,M,"Diarrhea, Gastric pain, nauesa",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,UNK,"Lisinopril, Atorvastatin, Omeprazole",none,none,,IV contrast dye,"['Abdominal pain upper', 'Blood test normal', 'Computerised tomogram normal', 'Diarrhoea', 'Nausea']",1,PFIZER\BIONTECH,SYR 1049534,GA,79.0,F,Grandson reported that she passed out while getting dressed for the day and that her arm was extremely sore and painfully. At the time of event it was reported that her BP was WML and she had not eaten since the night before. She is not a diabetic.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PUB,Patient grandson reported thyroid medication and a daily vitamin,unknown,Pacemaker,,Codeine,"['Loss of consciousness', 'Pain in extremity']",2,MODERNA,SYR 1049535,PA,34.0,F,"2/16/21 1500 PM received covid vaccine, 2/17/21 at 2200 pm started itching persistently around areas where clothing fit tightly along with a rash. Rash started to spread to bilateral shins appearing as welts. Pt. states that she took claritin and called a nurse. Pt. then took benadryl 25 mg po. Pt. then started taking 50 mg of benadryl for worsening rash and itching. Pt. states that itching and rash are still present as of 2/23/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,OTH,"synthroid, multivitamin",denies,stage I thyroid cancer,,denies,"['Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 1049536,GA,50.0,F,"Developed symptoms of COVID-19 and tested positive with PCR test for COVID-19 on 1-29-2021. Symptoms included cough, rhinorrhea, sore throat, sinus congestion, severe headache, weakness, body aches, N/V/D, fever, chills, night sweats, abdominal pain. Was quarantined for 10 days post symptom onset.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/26/2021,1.0,PVT,"FLEXERIL AS NEEDED, HYDROCODONE 7.5 MG PRN, MOTRIN 800 MG PRN, EMERGEN-CEE PRN, ONE-A-DAY MULTIVITAMIN DAILY",NONE,NONE,,"ERYTHROMYCIN CAUSES N/V, TRAMADOL CAUSES N/V POLLEN ALLERGY","['Abdominal pain', 'Asthenia', 'COVID-19', 'Chills', 'Cough', 'Diarrhoea', 'Headache', 'Nausea', 'Night sweats', 'Oropharyngeal pain', 'Pain', 'Pyrexia', 'Rhinorrhoea', 'SARS-CoV-2 test positive', 'Sinus congestion', 'Vomiting']",1,PFIZER\BIONTECH,IM 1049537,MD,69.0,F,Severe lump on arm and rash.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/15/2021,7.0,OTH,"metformin, simvistatin, lisiniprol, fiber, zinc, viatimin C, fish oil, zinc, calcium",no,"diabetic, hypertension",,"doxycyclin, vancomycyn","['Peripheral swelling', 'Rash']",UNK,MODERNA, 1049538,MA,68.0,F,Reported that she experienced slight blurry vision. Moved to observation chair- BP 124/76 pulse 72. Had 5 oz bottle of water. Reports that she has had high blood pressure. After 5 minutes- vision no longer blurry. Reported that she believe she was anxious.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,SCH,unknown,unknown,unknown,,unknown,"['Anxiety', 'Hypertension', 'Vision blurred']",1,PFIZER\BIONTECH,IM 1049539,TN,71.0,F,"Per patient: "" I received my 2nd vaccine on Friday, February 12, 2021 and started breaking out on Saturday, February 13, 2021 around my forehead and into my eyebrow. I developed body aches as well as a headache and arm soreness. I went to the dermatologist on Wednesday, February 17, 2021 and they cultured the lesions and results came back positive for shingles on February 22, 2021. I called the health department to let you know. """,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,PUB,Prefer not to answer,None,Chronic Back Condition,,Penicillin,"['Culture', 'Headache', 'Herpes zoster', 'Limb discomfort', 'Pain', 'Rash']",2,PFIZER\BIONTECH,IM 1049540,OK,70.0,F,approx. 5 minutes after receiving the vaccine client started c/o nausea. She was given an antacid and it helped. She says by the time she got home she had a Headache that lasted off and on for 3 days. She took Excedrin and it helped.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,OTH,"Lisinopril, HCTZ, Prilosec, baby ASA",none,"hypertension,",,NKDA,"['Headache', 'Nausea']",2,PFIZER\BIONTECH,IM 1049541,CA,52.0,M,should have received 2nd dose of moderna but was mistakenly given pfizer,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,PVT,,,,,,['Interchange of vaccine products'],2,PFIZER\BIONTECH,SYR 1049542,CA,26.0,M,"Patient's Psoriasis flared up, he had itching , redness of the healing , very extensive",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/03/2021,0.0,OTH,"Apremilast 30 mg twice a day , calcipotriene0.005%cream twice a day, Triamcinolone 0.1% cream twice a day","Chronic Hep C , Guttate psoriasis. sialoadenitis of the submandibular gland","Chronic Hep C , Guttate psoriasis. sialoadenitis of the submandibular gland",,NKA,"['Erythema', 'Pruritus', 'Psoriasis']",1,MODERNA,IM 1049543,GA,43.0,M,"Woke up on 2/13/2020 and upon standing had severe vertigo that lasted 10-15 seconds accompanied by nausea and vomiting. He then would then have on and off again vertigo for 6 days through 2/19/2020 accompanied by nausea (no vomiting). Vertigo was mostly positional, worse when going from recumbent position to sitting or standing. Would occur throughout the day. Experienced extreme fatigue from 2/13/2021 through the 2/19, that was progressively better as time went on. , Experienced general weakness, mental fogginess, and ""heaviness"" behind eyes and in the occipital muscles. Muscle aches in legs and torso were worse in the AM and present from 2/13/21 to 2/19/21 that got progressively better further out from vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/13/2021,9.0,WRK,None,None,None,,Mild environmental allergies to dog and cat dander,"['Asthenia', 'Asthenopia', 'Fatigue', 'Feeling abnormal', 'Myalgia', 'Nausea', 'Vertigo', 'Vertigo positional', 'Vomiting']",2,MODERNA,IM 1049544,GA,58.0,F,Toung swollen,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,Unknown,,,,,['Swollen tongue'],UNK,MODERNA, 1049545,IN,46.0,F,"Excessive tremors, inability to walk due to shaking uncontrollably. Delayed speech. Severe headaches, body aches, and muscle pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/09/2021,4.0,MIL,Desvenlafaxine sucer 100 mg daily Trokendi XR CAP 100 mg daily Simvastatin Tab 20 mg,None,None,,MRI contrast Die,"['Gait inability', 'Headache', 'Myalgia', 'Pain', 'Tremor']",UNK,PFIZER\BIONTECH, 1049546,,68.0,F,"""Cotton mouth"" within minutes, left arm swelling, weak swallow",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/18/2021,0.0,UNK,,,,,,"['Dry mouth', 'Dysphagia', 'Peripheral swelling']",UNK,MODERNA,IM 1049547,NE,79.0,F,"Woke up with severe dizziness, nausea/vomiting and increased while at work(denies palpitations). In ER 1/2/2021-CT of head(WNL), MRI (saw lesion and physician thought she had a stroke). Neurologist consult on 1/3 and felt it was not a stroke and unsure the reason of dizziness.. 1/3 no arm or leg weakness. Order to see a cardiologist d/t residual dizziness and advised against 2nd moderna covid 19 vaccine.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,12/01/2020,01/02/2021,32.0,PVT,"losartan, amlopidine, Lipitor, levothyroxine",none,"hypothyroidism, high cholesterol",,none,"['Central nervous system lesion', 'Cerebrovascular accident', 'Computerised tomogram head normal', 'Dizziness', 'Laboratory test', 'Magnetic resonance imaging brain abnormal', 'Nausea', 'Vomiting']",1,MODERNA,IM 1049548,MO,37.0,F,"About 10 min after patient received 2nd dose, swelling on face and eyes. patient described difficulty breathing/something in throat. administered 1 dose of epipen. within 1 minute reaction was getting better, patient was back to normal in 5-10 min. facility called ambulance, patient was taken to hospital for futher evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,SEN,,none,none,,none,"['Dyspnoea', 'Eye swelling', 'Swelling face']",2,MODERNA,IM 1049550,GA,65.0,F,"Raised red rash & itching around injection site. About 6-inches in diameter. Purplish bruising at injection site, about 2-inches in diameter.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,02/05/2021,8.0,PHM,"Acyclovir, Aspirin, Atorvastatin, Baclofen, Bisoprolol Fumarate, Brilinta, Cetrizine, Citalopram, Clonazepam, Gabapentin, Lisinopril HCTZ, Metformin, Montelukast, Pantoprazole. Avonex, interferon Beta 1-a Trulicity",Sinus infection,Multiple Sclerosis,,"Sulfa, Tetracycline, Eggplant, Latex, Diflucan","['Injection site erythema', 'Injection site haemorrhage', 'Injection site pruritus', 'Injection site rash', 'Urticaria']",1,MODERNA,IM 1049551,NC,28.0,F,"fever of 102 for 2 days unrelieved by Tylenol, nausea, malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,PUB,"Singulair, Zyrtec, Cryselle (birth control)",none,asthma,,"Codeine, caffeine","['Malaise', 'Nausea', 'Pyrexia']",2,MODERNA,IM 1049552,IL,43.0,F,It is itchy and firm. She has been using a hydrocortisone cream and tylenol so far. It is warm to the touch. it is increasing in size.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/10/2021,02/11/2021,1.0,UNK,,,,,,"['Induration', 'Pruritus', 'Skin warm']",1,MODERNA, 1049553,CO,44.0,F,Patient had normal period January 20 for 5 days. Not due for next period until February 17. Started light spotting after the vaccine shot on the evening of 2/5 through 2/14. Menses stopped for 2 days and then started normal period.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,PVT,None,None,None,,None,['Metrorrhagia'],2,MODERNA,IM 1049554,PA,30.0,F,Breakout of rash on hands lasting about 2 weeks,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/11/2021,7.0,PVT,,,,,,['Rash'],UNK,PFIZER\BIONTECH, 1049555,,71.0,F,"Itchy, red rash about 2-3 inches in diameter near vaccination area.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/14/2021,02/22/2021,8.0,UNK,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash']",UNK,MODERNA, 1049556,PA,34.0,F,I started having fatigue around 7 hours after the shot was administered. My temperature went up 1.5 degree. Then 14 hours later I had chills and aches. Then I woke up with night sweats that drenched my sheets and clothes. Then I had a stabbing pain in my chest on the left side.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PVT,Plaquenil Concerta Viibryd B12 Benlysta,None,Lupus Eczema,,,"['Body temperature increased', 'Chest pain', 'Chills', 'Fatigue', 'Night sweats', 'Pain']",2,PFIZER\BIONTECH,SYR 1049557,TX,49.0,F,"Head ached started about 2 hours after dose, later in the day slight nausea, and joint pain that lasted for 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,UNK,,,,,,"['Arthralgia', 'Headache', 'Nausea']",2,MODERNA,IM 1049558,MI,77.0,F,fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,SEN,"Atorvastatin Calcium Tablet 20 MG Give 1 tablet by mouth at bedtime related to HYPERLIPIDEMIA, UNSPECIFIED (E78.5) Pharmacy Active 6/9/2017 21:00 6/9/2017",no,"Parkinson's, PVD, lymphedema lower extremities, gerd , overactive bladder, anxiety disorder, major depressive disorder, h, chronic pain , muscle wasting and atrophy, hyperlipidemia",,"cipro, cephalosporins, sulf abx",['Pyrexia'],2,MODERNA,IM 1049559,MI,50.0,F,"Acute Respiratory Failure with Hypoxia, Phrenic Nerve Dysfunction Right side",Not Reported,,Not Reported,Yes,14.0,Not Reported,N,01/06/2021,01/10/2021,4.0,PVT,Loratadine 10mg QD Omeprazole 20mg QD Triampterine/ HCTZ 37.5/25mg QD,None,HTN GERD,,Sulfa,"['Acute respiratory failure', 'Computerised tomogram', 'Hypoxia', 'Mast cell degranulation test', 'Phrenic nerve injury', 'Pulmonary function test', 'X-ray']",1,MODERNA,IM 1049560,CT,86.0,M,"Pt reported feeling light headed shortly after his injection. Pt evaluated by EMS, BP 160/80. Pt reported he was feeling very hungry and can often get light headed when hungry. Pt signed refusal for EMS transport. Pt was given ED precautions. Pt reported feeling better when he left after eating a snack and drinking water.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PUB,Information unavailable,None,Information unavailable,,None,"['Blood pressure increased', 'Dizziness']",1,MODERNA,IM 1049561,CA,34.0,F,"9 days later red itchy patch at injection site as well as itchy bumps on back of hands, elbow, knees and feet.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PVT,Floradix iron + herbs,,,,,"['Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Skin reaction']",1,MODERNA,SYR 1049562,RI,66.0,F,"Two days after vaccine: extreme fatigue and chills. Symptoms lasted just that one day. Four-five days after vaccine, full-body itching. Just thought it was my eczema flaring up (it's worse in the winter). After about 2 weeks, developed red areas on my body (torso, arms, legs and feet) - self-monitored - but got progressively worse. Dermatologist believes it is eczema aggravated by the vaccine. Provided a cortisone injection (right arm). Will monitor for two weeks to determine improvement or lack of improvement.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/02/2021,5.0,PVT,"Famotidine, Fenofibrate, Rosuvastatin, Losartan, Fish Oil Gummies, Ibratropium Bromide, Fluticasone Propionate, Montelukast",,"eczema, chronic rhinitis",,"Aspirin, Benedryl, Cerumenex","['Chills', 'Erythema', 'Fatigue', 'Pruritus']",1,PFIZER\BIONTECH,SYR 1049563,VA,36.0,F,"Headache, Tired, Fatigue, Leg and arm shooting pain",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/21/2021,9.0,PVT,,,,,,"['Fatigue', 'Headache', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 1049564,,40.0,F,"mild headache 10 hrs after 2nd dose; malaise in the morning, the day after 2nd vaccine administration; took tylenol and felt normal within an hour",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/01/2021,02/01/2021,0.0,UNK,none,none,none,,none,"['Headache', 'Malaise']",2,PFIZER\BIONTECH, 1049565,PR,38.0,F,"On the next day the patient started to have fevers, headaches, couldn't stand up. In the second and third day after the vaccination the patient started to feel joint pain, tingling sensation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,None.,None.,None.,,"Cipro, Pennicilina.","['Arthralgia', 'Headache', 'Paraesthesia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1049566,AL,35.0,F,"large red tender spot on left arm from 12 hours after vaccine (still continuing), fatigue, chills, weakness, body aches, severe headache from 20 hours until 38 hours after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/22/2021,1.0,PVT,"aspirin, vitamins, immune supplement, tylenol",shingles,pseudoaneurysm in carotid artery,,none known,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site pain', 'Pain']",2,MODERNA,IM 1049567,MN,51.0,M,"Itchy and tingly hands/arms in morning of 2/22/21. Rash broke out on body in the evening (face, legs, shoulders, waist, thighs/groin). Took a Benadryl and ibuprofen. Symptoms improved by morning, but still evidence of the rash. Took normal allegry meds in AM. Will monitor symptoms moving forward.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/22/2021,4.0,PVT,cetrizine hydrochloride 10 mg 1x day fluticazone propionate 50 mcg each nostril 1x day,,,,seasonal,"['Paraesthesia', 'Pruritus', 'Rash']",2,PFIZER\BIONTECH,SYR 1049568,CA,33.0,F,"Left hand and middle finger hurt to the touch, tingly down arm, numbness in arm/hand. Hand and arm symptoms lasted approximately 48 hours from on-set. Also experienced fatigue, headache and arm soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/14/2021,1.0,OTH,Nora-B birth control,None,None,,Allergy to Tramadol-causes numbness in legs,"['Fatigue', 'Headache', 'Hypoaesthesia', 'Limb discomfort', 'Pain in extremity', 'Paraesthesia']",1,PFIZER\BIONTECH,SYR 1049569,MO,66.0,F,"For several days after receiving vaccine, my arm was tender and hot. Then I think everything was OK. On February 22, I noticed a red circular spot that was maybe 5 or 6 inches across and was hot. I assumed it was ""covid arm"" and did nothing.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/09/2021,02/22/2021,13.0,PVT,,,,,,"['Pain in extremity', 'Rash erythematous', 'Skin warm']",UNK,MODERNA, 1049570,CO,53.0,F,"Chills, vomiting, diarrhea, fever to 101, severe headache and muscle pain: Day 2: fever to 102, muscle aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/04/2021,1.0,PVT,"Fish oil, biotin, collagen",None,None,,NO,"['Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia', 'Vomiting']",2,MODERNA,IM 1049571,CO,37.0,F,"1/7 I started having breast pain. 1/8 I had a fever and chills, breast redness and diagnosed with Mastitis in my right breast. I had severe fatigue and was prescribed a 7 day antibiotics and within 3-4 days I begin to feel back to normal. On 1/8 I had a COVID test which was negative. My breast milk supply went down on the right breast until the mastitis was resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,01/08/2021,21.0,PVT,"flovent inhaler 110 mcg, doxclilimine, Singular, Nexplanon BC Implant",no,Asthma,,no,"['Breast pain', 'Chills', 'Erythema', 'Fatigue', 'Mastitis', 'Maternal exposure during breast feeding', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 1049572,FL,75.0,F,Bell's Palsy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/22/2021,21.0,PVT,none,none,,,sulphur & IVP dye,['Facial paralysis'],1,MODERNA,SYR 1049573,IL,37.0,M,Error: Wrong Patient (documentation in EMR),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,SEN,,,,,,['Wrong patient received product'],1,PFIZER\BIONTECH,IM 1049574,OK,68.0,F,"Starting about 8 hours after the shot I began having chills; within 3 hours after the chills started, I felt feverish and fatigued; the chills and fever continued through the night and into the next morning (about 15 hours after chills began); for the next 3 hours, I was fatigued and slept. After then taking a generic acetaminophen, the symptoms lessened. Occasional chills continued through the next night. Once symptoms started, it was about 34 hours before they were gone. I did not seek medical attention.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,PUB,Levothyroxine; OTC: One A Day multi-vitamin; calcium supplement; cranberry supplement,none,hypothyroid,,penicillin,"['Chills', 'Fatigue', 'Pyrexia']",2,MODERNA,SYR 1049575,TX,53.0,F,"headache, chills dizziness, lightheadedness began about 24 hrs after the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/10/2021,1.0,PVT,,,,,,"['Chills', 'Dizziness', 'Headache']",2,MODERNA,IM 1049576,,35.0,F,"Vaccine was received on 02/19/21 on her left arm at 11:55am. She said her arm soreness began at 5:00pm that day. The next day 2/22/21 she began to feel fatigue, chills, body aches, headache, and had a fever of 101. On 2/23/21 she is still experiencing a headache and body aches. She treats her headaches and body aches with Tylenol and she said it makes her feel better for about 4 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,UNK,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",2,MODERNA, 1049577,TX,48.0,M,"at 11:30 am the day after vaccine i began to feel chills, shaking, and they after eating something i started feeling nausea, headache and fever. Drove home at 2:30 to 3:30 and checked my fever, it was 104. Injection site is swollen, tender, red, and was not like that the day of injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/21/2021,02/22/2021,1.0,PHM,Tylenol,,"high blood pressure, obesity",,only insects,"['Chills', 'Cold sweat', 'Headache', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Nausea', 'Pyrexia', 'Tremor']",1,MODERNA, 1049578,LA,69.0,F,pt stated when she bled when she was given the covid vax and was told that it may have gotten in her veins. She woke up the next day with a rush of light headiness and dizziness that she still has to this day. She said her blood pressure is normal so she has contacted her PCP yet but will call them to let them know.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/12/2021,1.0,PHM,"lallopurinol 100mg, loratadine 10 mg, potassium cler 10mg, donepezil 10mg, omeprazole dr 20mg, amlodipine 10mg, amitiza 8mcg cap, simvastatin 40mg, gabapentin 600mg, clonidine 0.2 mg, meloxicam 7.5 mg, bumetanide 2mg, olopatadine 0.25 ml,",no,"HBP, early dementia, cholesterol, gout, constipation",,sulfa,"['Dizziness', 'Injection site haemorrhage']",1,MODERNA,IM 1049579,VA,60.0,F,"Fever, Body ache, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/15/2021,02/15/2021,0.0,PVT,,,,,,"['Headache', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 1049580,LA,48.0,F,At approximately 42 hours after vaccination developed a rash covering approx. 50 to 60% of body. resolved in less then 12 hours after taking oral Benadryl and Benadryl cream.,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/12/2021,01/23/2021,11.0,PVT,,,,,,['Rash'],1,MODERNA,IM 1049581,SD,70.0,M,Veteran reported he was dizzy with flu-like symptoms for 2 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PVT,"Pimavanserin, Tamsulosin, Carbadopa/Levadopa, Pantroprazaol, Tramadol, Docusate/Sennosides, Amitriptiline, Certrizine, Aspirin, Zolpidem, Baclofen, Diclofenac, Allopurinol, Simethicone, Polyethylene Glycol, Fish Oil, Garlic, Senior Multi-v",none,"urinary frequency, anxiety, chronic PTSD, allergic rhinitis, spinal stenosis, low back pain, constipation, colon polyps, hiatal hernia, lipoma of intra-abdominal organs, steatosis of liver, IBS, Parkinsons, Gout, GERD, hyperlipidemia",,no known allergies,"['Dizziness', 'Influenza like illness']",1,MODERNA,IM 1049582,CO,42.0,F,"Site: Pain at Injection Site-Medium, Systemic: Weakness, Error: Wrong Dose of Vaccine - Too High",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/23/2021,1.0,SEN,,,,,,"['Asthenia', 'Incorrect dose administered', 'Injection site pain']",2,PFIZER\BIONTECH,IM 1049583,IL,66.0,F,"Emergency room 1/25/21 HPI patient is a 66 y.o. female who presents with dizziness, nausea, and vomiting. Patient reports that she began having acute episodic dizziness and vertigo early this morning when she rolled over in bed. She states the dizziness became so bad it made her nauseous and she began vomiting. Patient reports she tried to take a Dramamine but was unable to keep it down, and thus it did not help. � Patient denies any ringing in the ears, decreased hearing, or ear pain. Patient does report she has had episodes of dizziness and vertigo like this in the past. Patient denies any fevers or chills. Patient does report mild frontal headache. Patient denies any chest pain, palpitations, or shortness of breath. �",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,01/18/2021,0.0,PUB,"Current Outpatient Medications: ? calcium-vitamin D (CALTRATE 600+D) 600-400 mg-Unit per tablet, Take 1 Tab by mouth daily., Disp: , Rfl: ? Cod Liver Oil 10 MINIM CAPS, Take 1 Cap by mouth daily., Disp: , Rfl: ? Coenzyme Q10 (CO Q 10)",,,,Latex Iodine,"['Dizziness', 'Full blood count', 'Headache', 'Metabolic function test', 'Nausea', 'Urine analysis', 'Vertigo', 'Vomiting']",1,MODERNA,IM 1049584,IN,78.0,M,"The following day after the vaccine at 5:00 AM he had joint and muscle pain and weakness, not able to move his legs. He would sit down in a chair and needed help to get back up. Headache, dizziness. He had a low grade fever of 100.1. This got progressively worse and then by evening got better. His wife called the visiting nurse that they had coming who she believes notified the doctor, and told them it would go away. By the next morning it was basically gone. He took Tylenol for the symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/02/2021,1.0,PUB,"Bupropion XL, Tamsulosin, Duloxetine, Lamotrigine, Lisinopril, Donepezil, Olanzapine, Oxybutynin, Memantine. Multivitamin, low dose aspirin, Vitamin B complex,","Went into the hospital on 12/3/21 and diagnosed with COVID-19, then discharged from there and went to the nursing home for rehab. He came home 12/22/2020.","Early dementia, high blood pressure, enlarged prostate. History of kidney cancer 5 years ago with kidney removal.",,"Sulfa, Bactrim.","['Arthralgia', 'Asthenia', 'Dizziness', 'Headache', 'Mobility decreased', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 1049585,NM,49.0,M,L shoulder pain with pain abducting arm at shoulder,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/30/2021,10.0,OTH,"Xarelto, Levothyroxine, MVI, Loratidine, symbicort",none,"Factor V leiden deficiency, Hypothyroidism, Hx - DVT/PE, Allergic Rhinitis, Asthma",,"Seasonal allergies - juniper, grasses, trees, food - peaches, mild pet allergies","['Arthralgia', 'Pain']",1,MODERNA,IM 1049586,TN,33.0,F,"Whole body aches, fatigue, headache, weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/23/2021,1.0,OTH,,,,,,"['Asthenia', 'Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 1049587,NY,35.0,M,Pt experienced back ache about 8 hours after receiving the vaccine. He described the pain as being stabbed in the kidneys. At 4 am on the day after his vaccine he woke up to a temp of103. He used a cold bath to reduce his temp and pain. Pt experienced more back pain latter in the day. He woke up the next day with more back pain and a temp of 104. Pt utilized a cold bath again.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PUB,"Claritin D, Bystolic,",None,"Hypertension, history of renal calculi",,None,"['Back pain', 'Pyrexia']",1,MODERNA,IM 1049588,NJ,54.0,F,"1/8 vaccination. My arm became tender, sore, hard at the injection site, red, hot, tender to touch. I went home. Fever over 101. I didn't feel well; fever chills, general malaise. Symptoms lasted for 2 weeks with sore arm. Probably 4-5 days with the flu-like symptoms. *took Tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PHM,,,arthritis,"Pertussis or Pneumovax; my arm got huge, swollen and red (almost like a small amount of cellulitis).",sulfa,"['Chills', 'Influenza like illness', 'Injection site discomfort', 'Injection site erythema', 'Injection site pain', 'Injection site warmth', 'Limb discomfort', 'Malaise', 'Pyrexia']",1,MODERNA,SYR 1049589,AK,24.0,F,Visible lip smelling under lower lip margin 1.5 cm x .25 cm. Pt. also c/o tongue tingling. Pt. had no other symptoms. VS stable and lungs were clear. No other swelling. Responded well to benadryl orally with reduced lip swelling within 20 minutes. Sent home with instructions to RTC for any increase in sx. and to continue benadryl through the night. Allergy to COVID 19 vaccine Moderna added.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PVT,,No. Patient is BF.,GERD,,Toradol Injection= Caused lip swelling,"['Lip swelling', 'Swollen tongue']",1,MODERNA,IM 1049590,OK,30.0,F,PATIENT BEGAN TO HAVE SHORTNESS OF BREATH AND PASSED OUT AFTER ADMINISTRATION,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,NONE,NONE,NONE,PATIENT REPORTS BEING ANXIOUS AND NAUSEOUS DURING ANY ADMINISTRATION BY INJECTION,NONE,"['Dyspnoea', 'Loss of consciousness']",2,MODERNA,IM 1049591,MA,15.0,M,Error: Patient Too Young for Vaccine Administered,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,SEN,,,,,,['Product administered to patient of inappropriate age'],1,PFIZER\BIONTECH,IM 1049592,DC,65.0,M,"Woke at 1 am with chills, fever and severe headache. Chills subside after 45 minutes. Woke at 4 am with severe headache and 102 degree fever. Headache and fever resolved approximately 7 am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/22/2021,1.0,PHM,None,None,High blood pressure,,None,"['Chills', 'Headache', 'Pyrexia']",UNK,MODERNA,SYR 1049593,CA,69.0,M,"The pt began to have chills, fever, body aches, followed by acute urinary retention. His history of benign prostatic hyperplasia was well controlled prior to retention. He required catheterization for 800cc urine and needed Foley cath for 7 days. He has now recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,PHM,"finasteride, Tamsulosin, lisinopril","BPH, controlled","BPH, controlled",,NKA,"['Catheter placement', 'Chills', 'Pain', 'Pyrexia', 'Urinary retention']",2,MODERNA,IM 1049595,MO,39.0,F,"Left arm sore for a couple days after the shot. Then woke up on day 9 after receiving and had hot, red, swollen, itchy rash. Rash is getting bigger as the days go on.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/17/2021,8.0,SEN,,,,,,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Limb discomfort']",1,MODERNA,SYR 1049596,PA,66.0,F,Fever 102.6. Fever lasted 36 hours with a downward trend Achy lasted 2 days Headache lasted 2 days Nausea lasted 2 days Chills lasted 36 hours Site pain level 8 lasted one week with less pain each day Fatigue lasted 36 hours Tiredness lasted 36 hours Dizziness- lasted 5 days All adverse reactions have resolved,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,PUB,Lotrel 5/20 qd Magnesium Citrate qd Super -B Complex qd Vitamin D3 2500 IU qd Cranberry 4200 mg qd Calcium tab 600mg qd Centrum Women 50+ qd,,,Site pain,Fluoroquinolones Opioids Adhesives,"['Adverse reaction', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,IM 1049597,NY,37.0,F,"Low grade fever for 4 days, relieved by Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,WRK,"Synthroid, lexapro, birth control pills",None,None,,None,['Pyrexia'],1,PFIZER\BIONTECH,IM 1049598,LA,73.0,F,"Left arm was red, itching after 7 days around injection site. ( lasted 4 days.) After 11 days top and bottom lips on inside of lips got fiver blisters. fiver blisters were still there after 3 weeks.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/04/2021,7.0,PHM,Triamterene 37.5 mg - Lisnopril tab 10 mg - Metformin850 mg - Meloxican 7.5 mg,none,Diabetes- Arthritis,,none,"['Injection site erythema', 'Injection site pruritus', 'Lip blister', 'Oral herpes']",1,MODERNA,SYR 1049599,SC,34.0,F,"I started experiencing high fever, (103) body aches, muscles, nauseated, diarrhea, and migraine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,WRK,None,None,None,,Topamax,"['Diarrhoea', 'Migraine', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1049600,ID,77.0,F,Large local reaction to the injection site starting day of injection and worsening over 4 days time. Secondary cellulitis developed requiring antibiotic treatment.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,PVT,,,,,,['Injection site reaction'],UNK,PFIZER\BIONTECH, 1049601,IL,66.0,F,Emergency room 1/28/21 HPI Patient is a 66 y.o. female who presents with complaints of left hip pain reports is moderate severe sharp ongoing over the past few days and aggressive worse reports symptoms is moderate,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/28/2021,16.0,PUB,"CURRENT MEDICATIONS No current facility-administered medications for this encounter. � Current Outpatient Medications: ? aspirin 81 MG chewable tablet, Take 81 mg by mouth daily, Disp: , Rfl: ? Cholecalciferol (VITAMIN D3) 1000 units ta",,,,nka,"['Arthralgia', 'Culture urine', 'Differential white blood cell count', 'Full blood count', 'Metabolic function test', 'Urine analysis', 'X-ray limb', 'X-ray of pelvis and hip']",1,MODERNA,IM 1049602,VA,36.0,F,"""Sick for a while""",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/16/2021,02/16/2021,0.0,PVT,,,,,,['Illness'],UNK,PFIZER\BIONTECH,IM 1049603,OH,59.0,F,Error: Wrong Patient (documentation in EMR),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/02/2021,01/02/2021,0.0,SEN,,,,,,['Wrong patient received product'],1,PFIZER\BIONTECH,IM 1049605,HI,32.0,F,"Tenderness on the injection site left arm, Right hip pain, Right elbow pain, Headache and fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,PVT,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Injection site pain']",2,PFIZER\BIONTECH,IM 1049606,PR,62.0,F,"Body aches, low blood pressure, tingling sensation in hands, symptoms lasted for a week.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,Unknown.,Unknown.,"HBO, Hypothyroidism.",,Septra.,"['Hypotension', 'Pain', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 1049607,KS,61.0,F,"The patient reports that the day following her 2nd vaccination she developed a fever (lasting 48 hrs) up to 101.1F, headache, abdominal cramps, nausea, diarrhea and numerous sores in her mouth.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,PVT,"Metformin, Effexor, Singulair, Tenoretic",Strep throat (dx'd shortly after receiving 1st dose on 1/20/2021). Diagnosed with internal shingles on 2/22/2021.,DM,Similar side effects after first dose but did not have mouth sores like this 2nd dose,Ultram,"['Abdominal pain', 'Diarrhoea', 'Headache', 'Nausea', 'Pyrexia', 'Stomatitis']",2,MODERNA,IM 1049636,NC,93.0,M,"Very harsh dysrhythmia; Parkinson's symptoms got worse with joint contractions, stiffening, and confusion; Napping more; Blood pressure has been haywire, sometimes going high and sometimes low; A spontaneous report was received from a consumer, who was also the daughter of a 93-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a very harsh dysrhythmia (arrhythmia), Parkinson's symptoms got worse with joint contractions, stiffening, and confusion (Parkinson's disease); he has been napping more than before (somnolence), and blood pressure has been haywire, sometimes going high and sometimes low (hypertension, hypotension). Medical history, as provided by the reporter, included COVID in July 2020 from which he fully recovered, slight dysrhythmia, Parkinson's (tremors only), and slightly elevated blood pressure. The reported stated the patient's baseline health had been pretty good and he was usually mobile, active, cognitive, and had speech. Concomitant medications included carbidopa monohydrate (+) levodopa, losartan, beta blocker (unspecified), and liquid morphine. On 20 Jan 2021, one day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number: 028L20A) intramuscularly in his right (dominant) arm for prophylaxis of COVID-19 infection. On 21 Jan 2021, around 2 pm, the patient had ""a very harsh"" dysrhythmia and his Parkinson's symptoms worsened with joint contractions, stiffening, and confusion. He had also been napping more than before. Since getting the vaccine, his blood pressure ""has been haywire"", sometimes going high and sometimes low. Treatment information was not provided. The action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, a very harsh dysrhythmia, Parkinson's symptoms got worse with joint contractions, stiffening, and confusion; napping more than before, and blood pressure has been haywire, sometimes going high and sometimes low, were considered not recovered/not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/21/2021,1.0,UNK,CARBIDOPA + LEVODOPA; LOSARTAN; BETA BLOCKING AGENTS; MORPHINE,Blood pressure increased (slightly); Dysrhythmias (slight); Parkinson's disease (tremors only),Medical History/Concurrent Conditions: COVID-19,,,"['Arrhythmia', 'Blood pressure fluctuation', ""Parkinson's disease"", 'Somnolence']",1,MODERNA,OT 1049637,CA,65.0,M,"miembro viril esta muerto-virile member is dead; bad taste in mouth; loss of taste; legs are very weak especially in the knees, sometimes not able to stand in his feet; pain in the arm; A spontaneous report was received from a consumer who was also a 65-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a little pain in the arm, bad taste in the mouth, loss of taste, legs are very weak, specially in the knees, not able to stand on his feet, and ""miembro viril esta muerto"" meaning ""his virile member is dead"" or having erectile dysfunction. The patient's medical history included a hernia intervention on 20 Jan 2021, HIV positive, and has headaches. Products known to have been used by the patient included a multivitamin and HIV medicines. Patient states that he received ""injections for headaches in his brain, "" however no medications are specified. Patient has no known allergies. On 25 Jan 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 25 Jan 2021, one day after the mRNA-1273 vaccine was given, the patient noted that he had a little pain in the arm but nothing to worry. On 28 Jan 2021, the patient stated that he started to have a bad taste in the mouth, loss of taste, legs are very weak, specially in the knees, not able to stand on his feet, and erectile dysfunction. Treatment information was not provided. Action taken with mRNA-1273 was not reported. The outcome of the events, little pain in the arm, bad taste in the mouth, loss of taste, legs are very weak, specially in the knees, not able to stand on his feet, and having erectile dysfunction is unknown.; Reporter's Comments: Based on the current available information, the absence of an other etiologies and temporal association between the use of the product and the start date of the reported event, a causal relationship cannot be excluded. Vaccination site pain is consistent with the known safety profile of the vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/25/2021,0.0,UNK,MULTIVITAMIN [VITAMINS NOS]; HIV Medicines,Headache NOS; HIV positive,Medical History/Concurrent Conditions: Hernia repair NOS,,,"['Ageusia', 'Erectile dysfunction', 'Muscular weakness', 'Taste disorder', 'Vaccination site pain']",1,MODERNA,OT 1049638,AZ,46.0,F,"Pneumonia; Loss of taste; Loss of smell; stared into space for hours; Covid Positive Test; Felt Spacy; Cough; A spontaneous report was received from a consumer concerning a 46 year-old female patient who experienced Covid-19 positive test [COVID-19], felt spacy [dizziness], stared into space for hours [staring], and pneumonia. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 13 Jan 2021, approximately five days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient started experiencing symptoms of coughing. On 17 Jan 2021, the patient tested positive for Covid-19. The patient reported she felt spacy and stared into space for hours. On 19 Jan 2021, the patient experienced symptoms of loss of taste and smell. On 24 Jan 2021, the patient's oxygen levels were going down. Treatment for the event of Covid-19 included azithromycin, prednisone, albuterol, and cough medicine. On 28 Jan 2021, the patient tested positive for pneumonia. Treatment for the event of pneumonia included levofloxacin. Action taken with mRNA-1273 in response to the events was unknown. The event of pneumonia was considered resolved on an unknown date. The outcome of the event of Covid-19 was unknown. The events, felt spacy and stared into space for hours, were considered resolved on an unknown date.; Reporter's Comments: Based on the concurrent Covid-19 infection, the events are assessed as unlikely related to mRNA-1273.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/15/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Ageusia', 'Anosmia', 'COVID-19', 'Cough', 'Dizziness', 'Oxygen saturation', 'Pneumonia', 'SARS-CoV-2 test', 'Staring']",1,MODERNA,OT 1049639,NM,40.0,F,"swelling on the left side of my face; Bell's palsy/ left side can not function properly. I have little eye, mouth and forehead movement; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982), via an unspecified route of administration (at the age of 40-years-old) on 26Jan2021 10:15 at a single dose in Left arm for COVID-19 immunization. Medical history was not applicable (N/A). The patient was not Pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced swelling on the left side of my face and Bell's palsy/ left side can not function properly. I have little eye, mouth and forehead movement on 05Feb2021 10:30. The patient reported, ""I have swelling on the left side of my face as well as Bell's palsy. My left side cannot function properly. I have little eye, mouth and forehead movement."" The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The outcome of the events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Therapeutic measures were taken as a result of the events which included anti-viral medication and a steroid. The events were assessed as serious (Seriousness criteria-Disabling/Incapacitating). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/26/2021,02/05/2021,10.0,SCH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: N/A,,,"['Facial paralysis', 'Swelling face']",1,PFIZER\BIONTECH, 1049640,AR,81.0,F,"diarrhea and it was just all bright red fresh blood/bright red blood with diarrhea; bright red blood coming from her anal area; feel heaviness, she just feels that heaviness.; she lost weight; This is a spontaneous report from a contactable consumer (patient). A 81-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EM9809) (at the age of 81-years-old), via an unspecified route of administration on 06Feb2021 between 12:30 and 1PM as a single dose for covid-19 immunization. The facility where COVID-19 vaccine was a doctor's office and administered anatomically located on the right arm. The patient medical history included: She has been diagnosed years ago 10 years ago, which was since she smoked with COPD and she is on breathing medication, but she has not had it due to getting in a donut hole with insurance and she cannot afford it, her hands also won't let her use it, She hasn't had it for 2 months. Arthritis. She has had no other vaccines on the same day or in the past 4 weeks, she had the flu shot back in Oct2020. Family Medical History: Her dad had heart problems and cancer. Her brother had cancer. Her mother had heart conditions. Concomitant medications included: Acetaminophen and Naproxen sodium. She was taking a lot of acetaminophen and Naproxen sodium for arthritis pain, but she has not had any since Friday night 05Feb2021. She did not want to take anything before the shot. She hasn't been weighed in a while, she lost weight. On 06Feb2021, at 8 o clock on the night, she experienced bright red blood coming from her anal area; then, she had diarrhea and it was just all bright red fresh blood, it was fresh new blood not dark at all. Today she is still having bright red blood with diarrhea; the blood seems like it is decreasing, it's being colored by diarrhea. She felt maybe in so many years is like when you have a period at times and feel heaviness, she just feels that heaviness. Caller reports that she does have a standing appointment with her provider tomorrow. The clinical outcome of the events bloody diarrhea and anal bleeding was not recovered, heaviness and weight decreased was unknown. She is scheduled for the second dose on 10Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/01/2021,,PVT,ACETAMINOPHEN; NAPROXEN SODIUM,,"Medical History/Concurrent Conditions: Arthritis; Cancer (father and brother); Cardiac disorder (mother and father); COPD (diagnosed 10 yrs ago, since she smoked with COPD, she is on breathing medication,hasn't had it for 2 months.); Smoker",,,"['Anal haemorrhage', 'Anorectal discomfort', 'Diarrhoea haemorrhagic', 'Weight decreased']",1,PFIZER\BIONTECH, 1049644,OH,68.0,F,"Noticed redness at injection site and and just below injection site around 2 am Tuesday, February 23, 2021. It's not painful to the touch and does not itch. Some areas look like ""welts"".",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/22/2021,10.0,OTH,"Hydrochlorothiazide 12.5 mg 1 Every Monday, Wednesday, Friday (Did not take until after vaccination) Atorvastatin 10mg 1 at bedtime",No,Hypertension; High cholesterol.,,Colgate toothpaste with the bubbles. Lip swelling and rash around mouth. Went to urgent care after 3 days as my symptoms had worsen. Given prednisone injection and tablets to take for 7 days. This was 4 or 5 years ago. Can still use Colgate but not that variety.,"['Injection site erythema', 'Urticaria']",1,MODERNA,IM 1049645,TN,76.0,F,"PATIENT PRESENTS TO COVID SITE FOR COVID VACCINATION. PATIENT'S PFIZER FORM INDICATES A FIRST DOSE NEEDED AND NO DOSE PREVIOUSLY GIVEN. PATIENT IS ADMINISTERED ONE PFIZER VACCINE LOT # EL9269 EXP 5/21 IN R DELTOID. UPON ENTRY INTO TENNIIS, IT IS DISCOVERED THAT THE PATIENT HAD IN FACT RECEIVED A FIRST DOSE OF MODERNA VACCINE LOT# 011J20A ON 1/11/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PUB,unknown,unknown,unknown,,Argon gas,['Incorrect dose administered'],2,PFIZER\BIONTECH,IM 1049647,CO,37.0,F,"On 2/15 I begin to have chill, body aches, headache, fatigue and breast pains which continued into the next day. I was again prescribed the same 7 day antibiotic and disagnosed again with Mastitis but this time the symptoms lasted a little longer and after about day 5 I began to feel myself again. A mammogram and an ultrasound has been ordered to see why I developed the Mastitis so frequently but is not scheduled for another few weeks out from today.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,02/15/2021,27.0,PVT,"Singular, Flovent Inhaler, Nexplanon BC Implant, doxclimine",nothing besides the AE to the 1st vaccine,Asthma,1/2021- Pfizer COVID-19,no,"['Breast pain', 'Chills', 'Fatigue', 'Headache', 'Mastitis', 'Pain']",2,PFIZER\BIONTECH,IM 1049648,WA,87.0,M,"I was notified on 2/22/21 that this patient passed away over the weekend. I do not know the details, nor can I confirm anything beyond what I was told. I believe the death occurred on 2/20/21 due to a massive stroke.",Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/20/2021,18.0,PHM,unknown,unknown,unknown,,unknown,"['Cerebrovascular accident', 'Death']",1,MODERNA,IM 1049649,NE,65.0,M,"During observation, patient stated he was lightheaded. Denied any other symptoms. No SOB, no oral or facial swelling, no rash or swelling. Vitals stable- BP 100/62, pulse 62, RR 12. Ate breakfast but had not had lunch. Patient was observed for 30 minutes and given water. Symptoms resolved by end of observation period.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,OTH,None,None,None,,None,['Dizziness'],1,MODERNA,IM 1049650,NY,37.0,F,"Low grade temp. Body aches, head ache, and fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/23/2021,1.0,WRK,"Synthroid, Lexapro, Birth control",None,None,,None,"['Fatigue', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1049651,IN,78.0,F,Started turning red on 2/2/21. Noticed when getting dressed. Red circle around injection site about size of half of orange. Later in day started itching a little. Next day size of half a grapefruit. Itching off and on. Didn't disappear until 2/7/21. Read online to use arm and apply cold. So i did this. every so often. N,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,02/02/2021,6.0,OTH,"Atenolol, Chlorthalid,, Losartan, Synthroid, Rosuvastin, Mometasone Furoate Spray, Arthritis Tylenol, Zyrtec, Centrum Silver, Bayer Regimen, Phytomega with Fish Oil, CoQ10, Preservision, Refresh Eye Drops, Pain-A-Trate Pain relieving topic",Tooth extraction on 1/2021,"Thyroid, arthritis, high blood pressure, irregular heart beat, high chloresterol - all controled with meds.",,"Iodine Codein, Tramadol, Percoset, Persantine, Tape, Cinnamon,","['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 1049652,NY,43.0,F,pt initially noted palpitations and shortness of breath. After several minutes improved and then pt developed lip and tongue swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,SEN,Biotin,none,none,,none,"['Cytokine test', 'Dyspnoea', 'Full blood count', 'Laboratory test', 'Lip swelling', 'Metabolic function test', 'Palpitations', 'SARS-CoV-2 antibody test', 'Swollen tongue']",UNK,PFIZER\BIONTECH,IM 1049653,,35.0,M,pt felt a lump in sternum like he swallowed something and it was stuck.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,UNK,,,,,,['Sensation of foreign body'],2,PFIZER\BIONTECH,IM 1049654,NJ,66.0,F,"Headache, felt like I was starting a bad cold , chills, low grade fever and every joint ached for 36 hours. Then it just went away.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/16/2021,1.0,OTH,RABEPRAZOLE SODIUM 20 MG,NONE,"DIVERTICULITIS,",,"SULFA , IODINE, SHELL FISH","['Arthralgia', 'Chills', 'Headache', 'Nasopharyngitis', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1049655,PA,38.0,M,Severe and debilitating lower back pain that lasted roughly 3 hours. Use of a heating pad for an extended period of time assisted with recovery.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,OTH,Famotidine and singular.,None,"Chronic Kidney Disease, Stage 2, Exercise Induced Asthma",,None,['Back pain'],1,MODERNA,SYR 1049656,VA,54.0,F,"C/o feeling itchy on arms, neck, knee. No rash noted at injection site or on arms. Blotchy essential noted neck right clavicle area. Denies pain, SOB, dizziness, nausea. P76. Checked by EMT. EMT instruct ti take oral benadryl when she gets home. Client stated that perfums,perfume, lotions can set off itchy feeling when shesmells perfume.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/23/2021,02/23/2021,0.0,OTH,,,,,,"['Pruritus', 'Rash macular']",UNK,PFIZER\BIONTECH,IM 1049657,WI,59.0,F,"Flu like symptoms 24 hours after shot. Fever, chills, sick to stomach, uncontrollable shaking!",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/09/2021,1.0,UNK,Levothyroxine,None,None,,Keeflex,"['Chills', 'Influenza like illness', 'Malaise', 'Pyrexia', 'Tremor']",1,MODERNA,SYR 1049658,VA,77.0,F,"bilateral lower leg edema started 24 hours after vaccine, associated with dizziness, leg spasm/tremors, unable to walk, resolved in 4 days. no prior history, no other new medications taken",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,PVT,"amlodipine, vitamin D3, benazepril, carvedilol, hydrochlorothiazide, relafen, trazodone, Flonase",none,"hypertension, hyperlipidemia, osteoarthritis",pneumococcal vaccine,"pneumonia vaccine, sulfa","['Dizziness', 'Gait inability', 'Muscle spasms', 'Oedema peripheral', 'Tremor']",UNK,MODERNA, 1049659,TX,45.0,F,"Moderna COVID-19 Vaccine EUA. Minor and expected tenderness the day after injection. Noticed 9 days after vaccination that the injection site is getting swollen and very itchy. Increasing redness. Taking OTC antihistamines and ibuprofen as needed. No need for additional intervention yet, but felt obligated to report and help provide information. Currently on injection day +10, increased redness, swelling, and itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/21/2021,9.0,PHM,"Azathioprine, cetirizine, vitamins A and D",Nothing acute that I know of.,"Autoimmune hepatitis, PCOS",,Sulfa antibiotics,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Tenderness']",1,MODERNA,IM 1049660,NY,,U,"Large (3 inch in diameter), red, hot, itchy, bump on left arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,OTH,,,,,,"['Erythema', 'Peripheral swelling', 'Pruritus', 'Skin warm']",2,MODERNA,IM 1049661,KS,63.0,F,"Reddness, swelling and warmth below injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,PUB,,,,,,"['Erythema', 'Skin warm', 'Swelling']",1,MODERNA,IM 1049662,ID,84.0,F,"Hospice patient with multiple comorbidities. Within hours of injection became lethargic and unresponsive, she remained in this state for 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,SEN,,,,,,"['Lethargy', 'Unresponsive to stimuli']",UNK,MODERNA, 1049663,NE,69.0,M,Client arrived to vaccine clinic with stomach ache. Denied fever or other symptoms and stated he thought he had food poisoning. Vaccine administered per client request. Client observed for 15 minutes and no other reaction noted. Patient left after 15 minutes. Later facility was told client returned to his apartment and called 911 to go the ER to be seen for stomach pain. Paramedics notified patient had received COVID-19 vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,OTH,Unknown,Complaining of stomach ache and food poisoning when entered for vaccination. No fevers.,Unknown,,None,['Abdominal pain upper'],1,MODERNA,IM 1049664,CO,62.0,M,"severe chills. shivering at night for 2 hours. no fever, some aching and malaise. this was 4 days after shot. all previous days was fatigued alittle chilled and arm sore. taking alot of tylenol drinking alot of water. things did not get worse.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/20/2021,3.0,MIL,"synthroid, coumadin, lasix, metaprolol. fish oil,",AFIB. was in hospital when offered first shot for AFIB.,"AVR, mild seasonal asthma.",,none,"['Chills', 'Malaise', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH,IM 1049665,CA,81.0,F,"Had body aches and low grade fever 99 +, took Tylenol 500mg, and fever broke. Next day just didn't feel well, tired and little nauseated. That lasted all day but next day felt fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/12/2021,1.0,PVT,"Atorvastatin 20mg., Losartan/HCTZ 100-12.5 mg., Calcium Citrate, Acidophilus Probiotic, Aspirin 81mg.,Vitamin D3, Omeprazole, Aller-tec, Vitamin B-12, Co-Q-10",None,Good health,,Codene,"['Fatigue', 'Malaise', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,IM 1049666,FL,55.0,M,profound hyponatremia,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/16/2021,5.0,WRK,,,,,,"['Blood sodium decreased', 'Hyponatraemia']",UNK,MODERNA,IM 1049667,KY,24.0,M,2nd dose of Moderna given to early. First dose given on 1/29/2021 and 2nd dose given 2/17/2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PUB,Unkown,none,Mild mental retardation osteoarthritis.,,tylenol,['Inappropriate schedule of product administration'],2,MODERNA,IM 1049668,OK,71.0,F,"Starting 16 hrs. Post vaccine; sniffles, fever 102 F. , mild bloody nose, arm pain, excruciating head ache and facial pain not relieved by #2 50mg Ultram every 4 to 5 hrs, lethargy, chapped lips and cold sore. February 23rd most symptoms gone except lethargy and cold sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,OTH,"Multi Vitamin, Vitamin C",None,Asthma,,Codeine,"['Chapped lips', 'Epistaxis', 'Facial pain', 'Headache', 'Lethargy', 'Oral herpes', 'Pain in extremity', 'Pyrexia', 'Rhinorrhoea']",2,PFIZER\BIONTECH,IM 1049669,MI,75.0,M,fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,SEN,"Theragran-M multivitamin tab 1 x day, Aspirin81 mg 1 x day, Tylenol cap 600 mg q 6 hr prn, Baclofen tab 5 mg 3 x day, cholecalciferol 50 mcg,atorvastatin calcium 40mg,",,"muscle wasting and atrophy, hx covid 19, osteitis deformans , Vitamin D deficiency , Obstructive sleep , hyperlipiden",,NKA,['Pyrexia'],2,MODERNA,IM 1049670,IL,92.0,F,"DX: Ileus Chief Complaint: Coffee-ground emesis, bowel obstruction Source of History: Patient � History The patient is a 92 y.o. female with a past medical history notable for COPD, dementia, history of DVT, reflux, hypertension, hypothyroidism, recent small bowel obstruction. The patient presents for evaluation of Worsening issues of coffee-ground emesis once more. This is very similar patient's last hospitalization were patient required NG to and monitoring for blood loss. Patient continues to be confused and not a good source of history. Staff notes that patient started this 1 day prior at skilled care facility was sent into the ER. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Patient shows no signs of any pain or discomfort",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,01/02/2021,01/11/2021,9.0,SEN,Current Outpatient Medications on File Prior to Encounter Medication Sig Dispense Refill ? acetaminophen (TYLENOL) 325 MG tablet Take 650 mg by mouth every 6 hours as needed for Pain � � ? albuterol (ACCUNEB) 0.63 MG/3ML nebulizer solution,,,,Codeine Ibuprofen Oxycontin,"['Condition aggravated', 'Confusional state', 'Haematemesis', 'Ileus', 'Intestinal obstruction', 'Memory impairment']",UNK,PFIZER\BIONTECH, 1049671,NY,35.0,M,"Temp of 103 and 104, stabbing back pain. Cold bath for treatment",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PUB,"Bystolic,",Hypertension,Hypertension,,None,"['Back pain', 'Pyrexia']",1,MODERNA,IM 1049672,OK,65.0,F,"30 minutes after vaccination on left arm 2 inch round red spot, bigger than half dollar, hot and hard, sore",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,UNK,"levothyroxine, hydroxychlorine",,,,,"['Erythema', 'Pain in extremity', 'Skin warm']",2,MODERNA,IM 1049674,FL,68.0,M,"Chills about 16 hours after vaccine.. lasted one hour sore arm 2 days . fatigue for 3 days , longer sleeping than usual.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,OTH,"Insulin, metformin, farxiga, welbutrin xl, lamotrogine, avorsytatin soligua",none,"diabetes, dysthimia",,none,"['Chills', 'Fatigue', 'Pain in extremity', 'Somnolence']",2,MODERNA,IM 1049675,IA,74.0,F,"Arthritic type flare in right hand with pain, swelling. Unable to grip due to stiffness and pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/12/2021,2.0,PHM,"Insulin, asa81 mg, thyroid, metoprolol, Metformin, Tylenol, Ropinirole, famotidine, vagifem",None,"Diabetic II, hypothyroidism, Gerd, Raynauds, limited systemic sclerosis, arthritis osteoporosis, dupuytrans,",,"Augmenting, and statins","['Arthritis', 'Grip strength decreased', 'Musculoskeletal stiffness', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 1049676,IL,63.0,F,"Starting at 6 pm in 17 the. Feelings of electrical shocks in various places in my body every 15 to 20 minutes stopping at 5 pm the 18 the. A sensation like getting a shock from an exposed outlet but not on skin, it was inside my body. Enough of a shock to be startling. One time it would be in right upper arm then upper leg, lower leg, sides, etc...",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PUB,"Levothyroxine, previous, pepto bismol, melatonin",,"Hypo thyroid, graves",,Eggs,['Paraesthesia'],2,MODERNA,UN 1049677,CO,27.0,F,"6 hours after receiving the vaccine I developed a sore arm & severe headache, later followed by chills, all over body aches, severe fatigue, nausea, diarrhea, and then a fever of 102.1 which lasted three days and did not break or go down with Tylenol. On the third day I had no symptoms at all other than slight fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,MIL,None,None,None,,"Environmental: dust mites, cats Seasonal: corn pollen, juniper , Rocky Mountain cedar","['Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 1049678,OR,63.0,F,"I was fine til about 2am when I was faint and light headed with flu-like symptoms, stuffy nose, body aches + terrible migraine headache. Was so sick that I was unable to find my migraine meds (prescribed by doctor). Have history of migraines but haven't had one in several month...I was dizzy and worried about thowing up and fainting. Note: usually never recieve the flu shot but not during 2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/21/2021,02/22/2021,1.0,OTH,Nothing,none,"seasonal asthma, allergies. history of migraines but now only occuring once every several months. Could not find prescription container with meds.",,Amoxicillin,"['Dizziness', 'Influenza like illness', 'Migraine', 'Nasal congestion', 'Pain', 'Syncope']",2,MODERNA,SYR 1049679,WI,30.0,F,Intense dizziness and vertigo. First two days- nearly constant and accompanied by nausea and headache. Dizziness lasting for more than 1 week. Vertigo still present after 7 days if laying in certain positions. Taking meclizine as needed for dizziness and motion sickness.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,UNK,Sertraline,,Asthma,,Apples Peaches Raw nuts,"['Dizziness', 'Headache', 'Nausea', 'Vertigo']",2,PFIZER\BIONTECH,SYR 1049680,PR,57.0,F,"Three days after vaccine administration, patient indicates feeling weakness and involuntary movements in both legs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/28/2021,3.0,PVT,Unknown,Unknown,Hypertension,,Unknown,"['Asthenia', 'Dyskinesia']",2,PFIZER\BIONTECH,IM 1049681,IN,47.0,F,"Fatigue, Dizziness, pain in breast and fullness/uncomfortable feeling under armpit",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,PVT,"Premarin RX Cream, OTC Probiotic, OTC Fiber Chew",none,none,,Onion and Amoxicillin,"['Axillary pain', 'Breast pain', 'Dizziness', 'Fatigue']",UNK,MODERNA, 1049683,NM,91.0,M,PATIENT EXPERIANCED CHEST PAIN AND ARM NUMBNESS.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,PHM,"Alprazolam. Atorvastatin, Metoprolol tartrate, omeprazole, and Ventolin.",,,,"codeine products, Demrol, Keflex, Iodine.","['Chest pain', 'Hypoaesthesia']",1,MODERNA,IM 1049684,IL,92.0,F,"DX: CVA History The patient is a 92 y.o. female with a past medical history notable for History of CVA, history of arthritis, history of COPD, history of DVT, history of reflux, history of hypertension, history of hyperthyroidism, recent GI bleed. The patient presents for evaluation of worsening weakness at skilled care facility. Patient had history of stroke. Patient was assessed there was found of have another stroke. Patient's other care and therapies were reviewed. Patient's blood thinners recently stopped within the last 3 months due to GI bleed requiring multiple transfusions. Patient has been slow to recover. Patient has struggled with intake and weight loss. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/23/2021,02/07/2021,15.0,SEN,Current Outpatient Medications on File Prior to Encounter Medication Sig Dispense Refill ? acetaminophen (TYLENOL) 325 MG tablet Take 650 mg by mouth every 6 hours as needed for Pain � � ? albuterol (ACCUNEB) 0.63 MG/3ML nebulizer solution,,,see vaers report #318100,Codeine Ibuprofen Oxycontin,"['Activated partial thromboplastin time', 'Asthenia', 'Blood creatine phosphokinase', 'Blood creatine phosphokinase MB', 'Blood glucose', 'Blood magnesium', 'Cerebrovascular accident', 'Chest X-ray', 'Computerised tomogram head', 'Culture urine', 'Decreased appetite', 'Dysphagia', 'Electrocardiogram', 'Fibrin D dimer', 'Full blood count', 'Glycosylated haemoglobin', 'Libido decreased', 'Liver function test', 'Magnetic resonance imaging', 'Metabolic function test', 'Prothrombin time', 'Transfusion', 'Troponin I', 'Weight decreased']",2,PFIZER\BIONTECH,IM 1049685,,64.0,F,"C/o feeling hot flush heart rate 104. Denies no dizziness, nausea, chest pain, or SOB. EMS evaluated P 94 148/99. Ok to walk with husband as nd left for home w husband 12:26 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/23/2021,02/23/2021,0.0,OTH,,,,,,"['Heart rate increased', 'Hot flush']",UNK,PFIZER\BIONTECH,IM 1049686,IA,41.0,F,"On 2/6/21 I experienced headache, fatigue, fever, chills, and body aches. along with sore arm on injection site. This lasted 24 hours. On 2/19/21 I noticed continued soreness in my arm on the injection site. I also began noticing itchiness. I now have a spotty rash all over the same arm along with itching and soreness. It looks like hives. It is localized to the arm of the infection. I did not experience these side effects, other than a sore arm, after the first dose I was given on 1/8/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,PVT,Citalopram 20 mg,None,None,,Allergic to Sulfa (rash),"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site urticaria', 'Pain', 'Pyrexia']",2,MODERNA,IM 1049687,CA,52.0,F,"within 5 minutes of receiving second Moderna vaccine, patient c/o itching to face. no visible hives.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PVT,none,none,none,itching to face after 1st dose of Moderna vaccine,none,['Pruritus'],2,MODERNA,IM 1049688,NC,42.0,F,"large cyst developed on left side of vagina, menstrual cycle was 3 weeks late",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/28/2021,7.0,PVT,"montelukast, proventil",,asthma,,amoxicillen,"['Asthma', 'Menstruation delayed']",1,PFIZER\BIONTECH,SYR 1049689,KY,72.0,F,"PT BEGAN TO C/O FEELING FUNNY AND DIZZY IMMEDIATELY FOLLOWING INJECTION. PT ALERT AND ORIENTED X 4, NO LOSS OF CONCIOUSNESS, BREATHING NORMAL, SKIN NATURALLY PALE, W/D WITH NO DIAPHORESIS. PT STATES SHE HAS NOT EATEN TODAY. TAKES BP MED AT 2PM. GAVE A PIECE OF MINT CANDY , OFFERED CRACKERS BUT DECLINED; SHE ALSO TOOK HER BP MED. OUTCOME: FELT BETTER AFTER 5 MINUTES, SHE STATES SHE THINKS IT WAS HER BLOOD SUGAR. CONTINUED TO MONITOR X 15 MINUTES WITH NO FURTHER INCIDENCE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PUB,"PLAVIX, TREMFYA, BP MED",NONE,"PSORIASIS, HTN",,NONE,"['Dizziness', 'Feeling abnormal']",1,MODERNA,IM 1049690,HI,28.0,F,Fatigue and difficulty concentrating,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/18/2021,0.0,PVT,,,,,,"['Disturbance in attention', 'Fatigue']",2,PFIZER\BIONTECH,IM 1049691,NC,90.0,F,A rash appeared more intensely at injection site but all over limbs and body. Went to general practioner who administered cetirizine 10mg 1x/day montelukast 10 mg 1x/day rash is drying and not as bright currently,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/12/2021,2.0,PUB,Vasculera TAb 1/day Eo3 3/day Ceremin 1 scoop/day Fast Blast 1scoop/day,none,poor circulation in legs,,No Known allergies,"['Injection site rash', 'Rash']",1,PFIZER\BIONTECH,IM 1049692,WI,73.0,F,"On Sat morning upon arising and taking a shower I noticed a red line almost welt on my arm by afternoon there were 2 lines and they were getting longer and wider. By Monday morning the area covered with puffiness and redness was about at least 4 inches wide and going almost entirely around the arm. It hurt and was very warm to touch along with starting to itch. It was not hard at the\at time. Placed a call to my doctor and was advised to see him or urgent care. I choose the later to do. In checking it out they mentioned that they have been seeing the quite often in the last couple weeks. Take an aspirin, tylenol or ibuprophn and put cold conpresses on for 20 minutes as often as I can. This morning (Tuesday 23rd of February) it has enlarged again some redness is gone but it apprears to be black and blue now. Still itching, I have not itched it as of yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/20/2021,2.0,PVT,"fish oi, turmeric, multiple vitamin, vitamin D, glucosmane , ezetimibe, atorvastin, buprophn pantoprazole, aspirin low dose, forosemide, metoprolol, clopidogrel",none,see above for medications related to conditions,,bee stings,"['Contusion', 'Erythema', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Skin warm', 'Urticaria']",1,MODERNA,SYR 1049693,OR,51.0,F,Headache x7 days Intermittent dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/16/2021,0.0,PVT,,,,,,"['Dizziness', 'Headache']",2,MODERNA,IM 1049694,FL,60.0,M,"Sore upper right jaw 3 teeth day one, sore bottom right jaw one tooth days 2, 3, 4 and counting",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/21/2021,20.0,OTH,Allegra escitalopram advair metformin Tylenol,One,Type 2 diabetes asthma,,Penicillin,"['Pain in jaw', 'Toothache']",2,MODERNA,SYR 1049695,NM,30.0,F,"1414: Patient had c/o ""heart flutters"" fell faint(fainted) and assisted safely to the ground. Patient was monitored and released. No further intervention",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PUB,"famotidine 20mg qday, methylphenidate 27mg ER qam, fludrocortisone 0.1mg qday, omeprazole 20mg qam, Pristiq 100mg qday, Rexulti 3mg qday, folic acid 1mg qday, progesterone micro 100mg qhs, ibuprofen (no dose)",Unknown,"MVA, TBI in 2007,Vagovasal and Hypotension post TBI, Celiac Disease",,"ibuprofen (no reaction noted), milk products (no reaction noted)","['Blood glucose normal', 'Cardiac flutter', 'Syncope']",1,PFIZER\BIONTECH,IM 1049696,MA,38.0,M,"100,1 degree Fever for approximately 24 hours. Treated effectively with Motrin and Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,UNK,"Sertraline, Buproprion",None,None,,None,['Pyrexia'],2,MODERNA,IM 1049697,NV,57.0,F,Pounding headache. Chills. Joint aches muscle aches body aches fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/13/2021,1.0,PHM,None,None,Von Willebrand?s disease Mitral Valve Prolapse,,Sulfa,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pain']",1,PFIZER\BIONTECH,SYR 1049698,KY,75.0,F,"Immediately after the vaccine she felt a tingling/little something going down into her hand, but she did not think about it being the shot and did not report it. Then went home, took a Tylenol and that afternoon her arm was sore like the normal reaction. She went to bed, woke up at 1:00 AM and her arm was killing her/hurting. She got up and went to the bathroom and noticed that her hand was swollen and the veins on the top of her hand were protruding. She looked in the mirror and noticed that the left side of her neck was swollen. Then she took her temperature and it was elevated, her normal is 97 and it was 99. Later on that day on Saturday the inflammation got better. She did not take anything for it. The symptoms have progressively gotten better and now her hand is normal, her neck this morning looked normal and her temperature is back to her baseline.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,OTH,"Levothyroxine, Estradiol, Alendronate sodium, zinc, vitamin C, Os-Cal, vitamin D3, collagen.",None.,"Sinus problems, thyroid disease.","The flu vaccine, arm at the site of the injection was swollen and hot. Her doctor told her from now on before she gets a vaccin",Avelox,"['Body temperature increased', 'Immediate post-injection reaction', 'Pain in extremity', 'Paraesthesia', 'Peripheral swelling', 'Swelling']",1,MODERNA,IM 1049699,VT,55.0,M,"Per H&P and physician notes, patient was admitted to hospital on 2/7/21 with status epilepticus from home. He had received his second dose of COVID19 vaccine on 2/6/21 per Emergency Department note. Patient was febrile on admission (40.7 Celsius) and was intubated. Patient had issues with hypotension, neurologic impairment, and metabolic issues. Received pressors, IV fluids, Keppra, IV antibiotics to cover for possible CNS infection. Lumbar puncture performed. Abnormal EEG on 2/9/21. Recurrent seizure on 2/10/21. Pt extubated on 2/12/21. Blood cultures, urine culture, and CSF culture all no growth. Sputum culture mixed oral flora. As of 2/22/2021, patient tolerating tube feeds, shakes head yes and no responding to questions.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/06/2021,02/07/2021,1.0,PVT,"Medication history from EMR: Mucinex, temazepam, potassium chloride, atorvastatin, clopidogrel, nabumetone, Refresh eye drops. Aspirin and levetiracetam are on medication list but caregiver reported he was not taking.",,"History of: traumatic brain injury, aspiration pneumonia, rheumatoid arthritis, rheumatoid lung, cardiac stents, quadriplegia, pseudophakia, pleural effusion, NSTEMI, MRSA, amblyopia",,None reported.,"['Blood culture negative', 'CSF culture negative', 'Culture urine negative', 'Electroencephalogram abnormal', 'Endotracheal intubation', 'Hypotension', 'Lumbar puncture', 'Metabolic disorder', 'Nervous system disorder', 'Pyrexia', 'Seizure', 'Sputum culture', 'Status epilepticus']",UNK,PFIZER\BIONTECH, 1049700,MI,21.0,F,"Nurse administered an empty syringe to a patient as an IM injection. The patient was supposed to receive a second dose of the COVID-19 Moderna vaccine but when the nurse administered the dose, the syringe was empty. The patient was brought back to actually receive the vaccine once the mistake was realized.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/12/2021,0.0,OTH,,,,,,['Incorrect dose administered'],2,MODERNA,IM 1049701,PA,89.0,F,Patient received Covid-19 Pfizer vaccine at nursing facility from a RPH. Patient remarked she had gotten a prior dose but did not have her CDC card indicating who the manufacturer was. Upon investigation it was confirmed by RN at facility that patient had received 1 dose of the Moderna Covid-19 Vaccine at her last facility. Patient was fine following injection to time of this report. Patient's doctor was notified and patient will not receive any more Covid-19 Vaccines.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,SEN,Unknown,Unknown,Uknown,,Unknown,"['No adverse event', 'Wrong product administered']",UNK,PFIZER\BIONTECH,IM 1049702,FL,43.0,M,"left forearm cramping, progressed to left shoulder and upper back over next week; symptoms have progressively worsened since that time",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,UNK,Losartan,Non,Htn,,Nkda,"['Condition aggravated', 'Muscle spasms']",1,PFIZER\BIONTECH,IM 1049704,VA,56.0,F,"""Blister""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/16/2021,0.0,PVT,,,,,,['Blister'],UNK,PFIZER\BIONTECH,IM 1049705,IL,69.0,M,"The patient is a 69 y.o. male with a past medical history notable for atrial fibrillation, CHF, COPD, history of GI bleed, coronary artery disease. The patient presents for evaluation of worsening issues with nose bleeds and shortness of breath. Patient is found in the ER to have a significant nose bleed which required packing. Patient was also found to be in atrial fibrillation. Patient was previously at skilled care facility undergoing care and it is unclear patient had been using illicit substances. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,12/30/2020,01/06/2021,7.0,SEN,Current Outpatient Medications on File Prior to Encounter Medication Sig Dispense Refill ? albuterol (PROVENTIL) (2.5 MG/3ML) 0.083% nebulizer solution Take 1 vial (2.5 mg) by nebulization every 6 hours as needed for Wheezing 120 ampule 2 ?,HPI: Patient 69 y.o. male presents for hospital follow up (12/07/2020-12/24/2020) where GI was consulted for anemia He presented to ED for worsening shortness of breath No s/s active GIB since admission; Hgb relatively stable� Accompanying 70 lbs weight loss since September Cardiology requesting anemia work up prior to heart cath/need for anticoagulation During hospitalization had EGD/colonoscopy with results below RUQ US reviewed;�Isolated TB elevation�1.2 indirect;� concern for ?hemolysis given �Haptoglobin normal/LDH significantly elevated at 440 hemoglobin has improved to 9 � Having normal bowel movements He is having issues with epigastric pain and concerned he may have a hernia or abnormality with gallbladder Declines wireless capsule endoscopy at this time � � EGD/Colon on 12/21/2020 with Dr. -mild ascending and sigmoid diverticulosis - medium to large internal hemorrhoids - two ascending colon polyps 12mm and 3 mm - mild gastritis - 3-4 duodenal AVMs in bulb and 2nd part SP APC Colon polyps: Tubular adenoma.,,,nka,"['Atrial fibrillation', 'Blood magnesium', 'Blood potassium', 'Brain natriuretic peptide', 'Cardiac monitoring', 'Chest X-ray', 'Condition aggravated', 'Drug screen', 'Dysphagia', 'Dyspnoea', 'Electrocardiogram', 'Epistaxis', 'Full blood count', 'Metabolic function test', 'Nasal cavity packing', 'Packed red blood cell transfusion', 'Prothrombin time', 'SARS-CoV-2 test', 'Troponin']",1,PFIZER\BIONTECH,IM 1049706,MN,62.0,F,"She is having chills, headache, and body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/20/2021,0.0,UNK,,,,,,"['Chills', 'Headache', 'Pain']",UNK,MODERNA, 1049707,CA,52.0,F,itching to face only. no visible hives,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PVT,none,none,none,,none,['Pruritus'],2,MODERNA,IM 1049708,ID,38.0,F,"On 1/7/2021 around 10am I had normal arm pain, my right arm started swelling, my skin turned really read, red hard rash, my face turned very red, pain on my shoulder & neck, and very bad headaches, my work send me o the emergency room, & also I had hard time seeing everything was very hard to see. I felt very nauseas I couldn't eat for the first couple of days, a lot of body aches & felt very fatigue. In the emergency room they prescribed me Trimodal & Zofran. I had to miss 4 days of work it lasted about 7 days the first 4 days my symptoms were sever but by the 5th day it was getting better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/07/2021,2.0,WRK,Linzess Ropinirole Kiptera Fludrocortisone Omeprazole Lexpro,,Depression Postural orthostatic tachycardia syndrome Gastroparesis,,Penicillin Crab,"['Arthralgia', 'Erythema', 'Fatigue', 'Headache', 'Hypophagia', 'Nausea', 'Neck pain', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Rash erythematous']",2,PFIZER\BIONTECH,SYR 1049709,FL,66.0,F,"Injection Site Reaction- rec'd injection at approx 2 PM on Tuesday, 1/26/2021. By evening I noticed a lump, that was tender to touch , had developed where the injection had been given. The lump resolved by the weekend. Then, a large circular red area developed. The area was firm to the touch and hot but not painful. This slowly faded and was about gone by the following weekend.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PHM,Amitriptyline 75Mg daily,none,none,,none,"['Injection site erythema', 'Injection site induration', 'Injection site mass', 'Injection site pain', 'Injection site reaction', 'Injection site warmth']",1,MODERNA,SYR 1049710,OH,66.0,F,Chills fatigue sore arm,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/23/2021,1.0,PUB,Flonase HCTZ Vitamin D,Some sneezing,,,Sulfa. Codeine,"['Chills', 'Fatigue', 'Pain in extremity']",2,MODERNA,IM 1049711,OH,77.0,F,"Bells Palsy right side of face, sx. almost gone on 2/23/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/29/2021,3.0,PUB,,,,,,"[""Bell's palsy""]",1,MODERNA,IM 1049712,TX,49.0,F,"Severe body aches, abdominal pain-over the following few hours was unable to walk due to muscle pain, HA and chills. I've had rhabdo in the past. This felt like rhabo however I did not have rhabdo in response to vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,WRK,"Zoloft, Wellbutrin, Magnesium, Omeprazole",None,"GERD, anxiety, depression, PTSD, migraine HA, Central OSA, osteoarthritis/DDD, mixed incontinence, vertigo",,none,"['Abdominal pain', 'Mobility decreased', 'Myalgia', 'Pain']",1,MODERNA,IM 1049713,NM,41.0,F,"Described as Covid arm, online. Red, itchy, warm and hard at the injection site. Started one week after the injection. ongoing at this point",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/15/2021,02/22/2021,7.0,PHM,none,none,"elevated BMI - semi chronic, sometimes elevated BP, but not when not consuming caffeine, delivered a baby on April 27th, 2020",,none,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,SYR 1049714,NH,20.0,M,"About 3d after shot, patient was at gym and noticed L arm had decreased strength and decreased grip strength. No improvement since. Now has noticed some intermittent L hand tremors and L leg weakness. This was all disclosed when patient returned for shot #2. Shot #2 not given. Patient advised to discuss with PCP first.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,02/01/2021,3.0,WRK,Unknown,Unknown,Unknown,,Unknown,"['Asthenia', 'Grip strength decreased', 'Hemiparesis', 'Muscular weakness', 'Tremor']",1,MODERNA,IM 1049715,MI,80.0,F,"0920, reporteed thickness in back of tonge,c/o trouble swollowing, able to drink water, 126/72, hr83, 02 sat 96% RA, rr 16 Called rapid response, NP assessed and rec ER, pt refused. 0940 Benedry 50 mg po given. Refused ER again, Agrreded to monitor until 11am Checked out At 11:10. Denied other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PVT,,,"timolol eye drops,",,"Sulfas, augmentin, darvan, nexium, doxycycline, milk, norgesic","['Dysphagia', 'Tongue disorder']",2,PFIZER\BIONTECH,IM 1049716,TX,69.0,F,"Covid-arm - the 8th day after vaccine at the injection site my arm became hard, blotchy red circle, inflamed, sensitive to touch - as of this day 2/23/21 it has lessened in severity - i applied lavender essential oil a couple of times since the 21st and it appears to be disappearing and less sensitive - I received the vaccine at pharmacy - I have reported the adverse effects to my doctor's office; and will inform pharmacy at my 2nd vaccine appointment on March 13, 2021 at 12 noon.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/21/2021,8.0,PVT,"Losartan for blood pressure; Rosuvastatin for cholesterol, Ultra Woman 50 plus daily multivitamin, L-lysine, zinc, Vit D, apple cider vinegar, theanine, CoQ10, turmeric",none,"high blood pressure, high cholesterol",,none that aware of,"['Injection site erythema', 'Injection site induration', 'Injection site inflammation', 'Injection site pain', 'Rash macular']",1,MODERNA,IM 1049717,CA,90.0,F,"The next day, patient was found down by children (lives alone.) Was confused, had had fecal incontinence many hours earlier (dried) . Neither syncope nor fecal incontinence had occurred before. Previously managed to walk w walker or holding on, do her own basic ADLs (toilet, use microwave, eat.) Now bed bound and requires 24 hour care, unable to stand even with assistance/PT. Mental state has returned to baseline. Spent a week in rehab but could barely comply w PT instructions due to pain/dizziness.",Not Reported,,Not Reported,Yes,5.0,Yes,N,01/26/2021,01/27/2021,1.0,OTH,"HCTZ, calcium with Vit D, APAP, naproxen, prolia",none,"Early stage Alzheimer's, frailty, mild controlled HTN, Osteoarthritis, osteoporosis. Past hx recurrent BPV.",,none known,"['Agitation', 'Anal incontinence', 'Bedridden', 'Cerebral atrophy', 'Cerebral ventricle dilatation', 'Confusional state', 'Dizziness', 'Dysstasia', 'Fall', 'General physical health deterioration', 'Laboratory test normal', 'Magnetic resonance imaging brain abnormal', 'Mental status changes', 'Muscle rigidity', 'Pain', 'Vertigo positional', 'Walking aid user']",1,PFIZER\BIONTECH,SYR 1049718,RI,73.0,F,"A 73 yr old female was found sitting in the observation area after receiving her first Covid 19 vaccine (Pfizer). Pt began to have a ?fuzzy? feeling and feeling of dissociation from her body. The pt got the attention of EMS and a wheel chair was brought over to her to bring her the private exam room. Pt remained in wheel chair and vs were taken. Initial bp was 168/102, hr was 97, spo2 was 97% ra. Pt states she has anxiety and feels she may have had a panic attack. Pt rested for 10 mins and had a drink of water. Pt vs were Retaken and improved. Pt pub was 153/104, hr was 85, resp 18, spo2 was 97% ra. Pt signed a form that she accepted treatment but refused transport. Pt was released back to observation area and proceeded to check out.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,UNK,"Lisinopril, Pepcid,",No illness,"Gerd, htn, depression",,No allergies to meds but yes to tree nuts,"['Anxiety', 'Feeling abnormal', 'Panic attack']",1,PFIZER\BIONTECH,IM 1049719,PR,32.0,F,Itchiness in tongue and throat. Benadril 25 mg Po/ solumedrol 125mg IV Home: Medrol 4mg PO/ Atorax 25mg.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PVT,Benadril 25 mg,"Asthma, sinuses, reflux.",None.,,"Lactose, eggs, seafood, penicilin, ASA","['Throat irritation', 'Tongue pruritus']",1,PFIZER\BIONTECH,IM 1049721,WI,71.0,F,"Patient reports experiencing fever and chills that began about 7-8 hours after receiving the 2nd dose. This lasted for about 36 hours. Patient also reports having nausea and vomiting that began about 12 hours after receiving the vaccine. This also lasted for about 36 hours total after receiving the vaccine. Patient also reports increased local pain, redness, erythema 36 hours after receiving the vaccine and states that this lasted for about 96 hours. The skin redness started locally to the injection site and then spread to covering the entire upper arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/15/2021,02/16/2021,1.0,PVT,,,,,,"['Chills', 'Erythema', 'Injection site erythema', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 1049722,MI,22.0,M,"One minute following vaccination, patient hunched over and fainted. Nursing staff lowered patient off chair and onto floor, raised patient feet above heart level. Patient woke 15 sec later and sat up slowly. Patient given juice and granola bar. Patient observed for total of 50 minutes. Patient vitals remained within normal limits throughout observation period. Patient released after reporting feeling better and all symptoms diminished. No other severe symptoms or concerns noted during observation period noted.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,Unknown,Unknown,Unknown,,Unknown,"['Immediate post-injection reaction', 'Syncope']",1,MODERNA,IM 1049723,GA,73.0,M,"Severe pain in right shoulder enough to wake me and keep me awake. Lethargy, low grade fever, aching muscles. Swelling of injection site and slight bruise.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PUB,Amlodipine 5mg Lorsartan /HCTZ 100-25mg Centrum Silver Red yeast rice CQ 10 100 mg,none,high blood pressure,01/21/2021,aspirin Hives,"['Arthralgia', 'Injection site bruising', 'Injection site swelling', 'Lethargy', 'Myalgia', 'Pyrexia']",2,MODERNA,IM 1049724,IL,72.0,F,"Emergency room 1/11/21 Patient is a 72 year old female who presents with decreased level of consciousness. The patient is a nursing home patient and had an episode of choking yesterday that was treated with a Heimlich maneuver. Nursing staff at the nursing home reports that she seems to be a bit less responsive today. However, the patient has been for the most part unresponsive for 3-4 months time following a COVID-19 infection. Of note, her oxygen saturation on room air is 72%. The patient is also febrile to 100.8�. She was unable to provide any information and the aforementioned information is gathered from nursing home staff report.",Yes,01/11/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/11/2021,12.0,SEN,"Current Outpatient Medications: ? albuterol (PROAIR HFA) 108 (90 Base) MCG/ACT inhaler, Inhale 2 puffs by mouth every 6 hours as needed for Wheezing, Disp: , Rfl: ? amLODIPine (NORVASC) 5 MG tablet, Take 5 mg by mouth daily, Disp: , Rfl",,,,Bandage adhesive Celebrex Latex Lincomycin Macrobid,"['Blood creatine phosphokinase', 'Blood creatine phosphokinase MB', 'Blood culture', 'Blood lactic acid', 'Chest X-ray', 'Choking', 'Condition aggravated', 'Culture urine', 'Depressed level of consciousness', 'Differential white blood cell count', 'Electrocardiogram', 'Full blood count', 'Metabolic function test', 'Pyrexia', 'Slow response to stimuli', 'Troponin', 'Urine analysis']",1,PFIZER\BIONTECH,IM 1049725,,56.0,F,"fairly severe, headache, lymph node swell",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,PVT,,,,,,"['Headache', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 1049726,VA,32.0,F,Sudden ringing in the ear- hearing loss,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/13/2021,0.0,PVT,,,,,,"['Deafness', 'Tinnitus']",2,PFIZER\BIONTECH,IM 1049727,AZ,66.0,F,"9-10 hours after injection became feverish, chills, migraine headache, muscle aches, dizzy. Swollen and painful at injection site on arm. Over next 36 hours fever was between 100-102. Nausea began 48 hours after injection. It is now Tuesday, almost 4 days since injection and am still dizzy and weak. Fever stopped yesterday and only light headache today. My husband also had all my symptoms except a much lower fever. We are wondering if we could have got a bad batch??? They said to expect 1-2 days of mild discomfort. This was like the worst flu I've ever had.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PHM,Lisinopril - 10 mg. Progesterone - 1 mg. Estradiol - 1 mg. Vitamin D. Magnesium. Calcium.,None,"30 years ago diagnosed with lupus. 20 years ago changed to MS. However have been in remission for 15 years and on no medications, no treatment. Began a vegan diet and no autoimmune disease symptoms.",,Sulfa drugs. Intravenous iodine.,"['Asthenia', 'Chills', 'Dizziness', 'Injection site pain', 'Injection site swelling', 'Migraine', 'Myalgia', 'Nausea', 'Pyrexia']",2,MODERNA,SYR 1049728,OH,78.0,M,Patient is positive for COVID-19 and being admitted to the hospital. Patient received dose 1 of the vaccine on 2/11/21 and began feeling ill several days before presentation to the ED. He is unable to pinpoint an exact date but states it has been a few days that he has felt unwell. Presentation to the ED was on 2/23/21 and his oxygen saturation on presentation was in the 80s with mild confusion. Patient is requiring supplementary oxygen. The patient is receiving dexamethasone.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/11/2021,02/19/2021,8.0,UNK,"warfarin, aspirin, Humulin N, Humulin R, levothyroxine, metoprolol succinate, nitroglycerin",,"Anxiety, diabetes mellitus type 2, Anemia, arthritis, hypertension, CKD stage 3, paroxysmal atrial fibrillation, IBS, left bundle branch block, history of PE, history of basal cell carcinoma",,no known allergies,"['Blood fibrinogen', 'Blood lactate dehydrogenase', 'C-reactive protein', 'COVID-19', 'Chest X-ray abnormal', 'Computerised tomogram abnormal', 'Computerised tomogram thorax', 'Confusional state', 'Full blood count', 'International normalised ratio', 'Lipase', 'Malaise', 'Metabolic function test', 'Oxygen saturation decreased', 'Oxygen therapy', 'Pneumonia viral', 'Procalcitonin', 'Pulmonary embolism', 'SARS-CoV-2 test positive', 'Serum ferritin']",1,PFIZER\BIONTECH,IM 1049729,NY,65.0,F,"7 days after injection the arm was inflamed and swollen and red. Fire to the touch. Like needles being stuck on my arm, the next day Saturday, i had most severe headache and chills, Mild fever and couldn't get out of the bed. Just subsided on Sunday evening. But it is still very sore and a little swelling at the injection site. Dr. was called and told me to take Aleve and ice pack it.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/19/2021,7.0,SCH,No,jan 22ndhad allergic reaction over the counter hair dye,No,,"Penicillin, eggs","['Chills', 'Headache', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Pyrexia']",1,MODERNA,IM 1049730,WI,67.0,F,"Headache for 8 days, shooting pains in head and all joints for 2 days, every muscle in body for 8 days so far. Pain in entire chest area left side from neck to waist on 6 & 7th day. Left arm is painful...big red blotch by injection site getting bigger everyday. On 7th day pain in left arm/chest area increased with numbness, heaviness & tingling.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/16/2021,0.0,PVT,none,none,none,,Sulfa,"['Arthralgia', 'Chest pain', 'Headache', 'Hypoaesthesia', 'Injection site erythema', 'Limb discomfort', 'Myalgia', 'Neck pain', 'Pain', 'Pain in extremity', 'Paraesthesia']",1,MODERNA,SYR 1049731,SD,74.0,F,"Presented to ER 2 days after COVID vaccine - SOB, chest heavy, thought she was having COPD exacerbation, fever, cough, aches. EKG was normal, troponin was normal, CXR was normal/stable from past images. Patient took an extra dose of furosemide that day, and was on prednisone too.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/10/2021,1.0,PVT,"simvastatin, Dulara Inhaler, Albuterol Nebs, Synthroid, Glipizide, Furosemide, Budesonide",,"COPD, CHF, Rheum Arthritis, Diabetes, numerous",,"piroxicam, lisinopril, cyclobenzaprine, penicillin","['Chest X-ray normal', 'Chest discomfort', 'Cough', 'Dyspnoea', 'Electrocardiogram normal', 'Pain', 'Pyrexia', 'Troponin normal']",2,MODERNA,IM 1049732,IL,59.0,F,Chills and fever of 101,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/23/2021,1.0,WRK,Tylenol,,,,,"['Chills', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1049733,TX,49.0,F,"Head ached started about 2 hours after dose, later in the day slight nausea, and joint pain that lasted for 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,UNK,,,,,,"['Arthralgia', 'Headache', 'Nausea']",2,MODERNA,IM 1049734,VA,42.0,F,unkown,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,PVT,,,,,,['Unevaluable event'],UNK,PFIZER\BIONTECH,IM 1049735,NY,21.0,F,"Very itchy rash in face, neck, ears and spread to arms and chest.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/18/2021,3.0,PUB,Insulin- Humalog for Type 1 diabetes Escitalopram 20mg Focalin Multi vitamin,Had excema on hands,Type 1 Diabetes Celiac disease,,Celiac disease - allergic to wheat,"['Rash', 'Rash pruritic']",1,MODERNA,SYR 1049736,ID,78.0,M,Broke out in pimple like rash on legs and arms. Itching.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,02/18/2021,9.0,PHM,"Levothyroxine, Dexilant, Pregabalin, Aspirin, Citrucel, Acetaminophen",None.,Acid reflux.,,Norco and Codeine.,"['Pruritus', 'Rash']",1,MODERNA,IM 1049737,VA,74.0,F,"Swelling, problems with swallowing",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/05/2021,0.0,PVT,,,,,,"['Dysphagia', 'Swelling']",2,MODERNA,IM 1049738,TX,30.0,F,"Headache, fever, nausea and fatique for approx. 2 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,PVT,,,,,,"['Fatigue', 'Headache', 'Nausea', 'Pyrexia']",2,MODERNA,IM 1049739,VA,71.0,F,muscle pan in chest,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/11/2021,9.0,UNK,,,,,"codeine, penicillin","['Electrocardiogram', 'Myalgia', 'X-ray']",1,MODERNA,IM 1049741,MI,84.0,F,fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,SEN,"Norco. Tylenol, amlodipine besylate, losartan, aspirin, ferrous sulfate, glycolax pwd, senna tabs",no,"RA, hyperlipidemia, htn",,Gold,['Pyrexia'],2,MODERNA,IM 1049742,IA,70.0,F,"pt states that she developed a red, feverish, inflamed, itchy spot on her below the injection site and above the elbow of the left arm. Pt had an appt w/ her oncologist which took a look at it and told her it looked she had cellulitis. She was prescribed Bactrim and prednisone. She said she took it for 5 days and it has since cleared up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/14/2021,3.0,PHM,"terazosin 10mg, gabapentin 100mg, prochlorperazine 10mg, lisinopril 10mg, glimepiride 2mg, lovastatin 20mg, metformin 500mg, Zyrtec 10mg, Lasix 20mg, potassium 10mg, Imodium prn, centrum silver",no,radiation therapy,,"ibuprofen, morphine, cephalexin,","['Cellulitis', 'Injection site erythema', 'Injection site inflammation', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 1049743,TX,24.0,F,"Severe fever and chills, flu like symptoms approx. 8 hours after injection lasting approx. 24 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,UNK,,,,,,"['Chills', 'Influenza like illness', 'Pyrexia']",1,MODERNA,IM 1049744,PA,60.0,M,"One week after 2nd vaccine, Friday 2/19, woke up with my right eyelid red, swollen, itchy, discharge. Saw eye doctor, OD., whom I work for. She diagnosed ""Swollen sub-mandibular & pre-auricular lymphatic nodes."" I am being treated with: 1) Erythromycin Ophth Oint 3.5GM 2) Prednisolone AC 1% Ophth Susp 5ML 3) Pataday Doctor believes that my viral infection might be a result of the Covid 19 vaccine, and gives assurance that her treatment will resolve issues. She is unsure whether, or not, I am considered contagious during this time? Inquiries at the college were unfruitful. I hope my reporting this is not a violation in any way. Many thanks.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,PUB,Melatonin - for sleep,None,HBP; chronic back pain,,None,"['Eye discharge', 'Eyelid oedema', 'Eyelids pruritus', 'Lymphadenopathy']",2,PFIZER\BIONTECH,SYR 1049745,SC,65.0,F,"No side effects, except itchiness, redness, sweeling, heat, mild soreness at injection site 8 days later",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/22/2021,8.0,PHM,"Citalopram 20mg, zyrtec 10mg, singular 25mg, advair inhaler, flonase nasal spray, pepcid AC, vit D, melatonin, vit magnesium, zinc, calcium, B 12 alternating with multi vitamin","Long covid ......got mild case of covid in March ?20, and never fully recovered, and developed new symptoms","Asthma , long covid",,None,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA,SYR 1049746,TX,42.0,F,"Same day of vaccination Headache, stomach cramps, nausea, fatique, and body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,PVT,,,,,,"['Abdominal pain upper', 'Fatigue', 'Headache', 'Nausea', 'Pain']",2,MODERNA,IM 1049747,FL,70.0,M,Moderna COVID-19 Vaccine EUA Severe dizzyness/spinning when bending over. would have fallen over headfirst if I hadn't righted myself. It was not like room was spinning but I was going into a black vortex. Scared to death.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/20/2021,2.0,OTH,"Atenolol 50mg , Ramapril 10mg, Atorvastatin 20mg, aspirin 81mg, fish oil, turmeric curcumin, multivitamin",None,"CAD, Kidneys stones",,None,"['Chest X-ray', 'Computerised tomogram head', 'Dizziness', 'Feeling abnormal', 'Laboratory test', 'Vertigo']",1,MODERNA,IM 1049748,VA,35.0,M,"shortness of breathe, fever 102-103, chills, weakness, congestion, dizziness, diarrhea for 36 hours - tried to treat with ibuprofen and tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/29/2021,1.0,SCH,none,COVID 19 symptoms on 12/26/2020; diagnosed on 12/31/2020,none,,none,"['Asthenia', 'Chills', 'Diarrhoea', 'Dizziness', 'Dyspnoea', 'Pulmonary congestion', 'Pyrexia']",1,MODERNA,SYR 1049749,MD,75.0,F,"1 week of nose bleed, admitted for ITP",Not Reported,,Yes,Yes,3.0,Not Reported,N,02/15/2021,02/15/2021,0.0,PVT,not on home medications,Diabetes,"Diabetes , Breast cancer status post lumpectomy and radiation",,NKDA,"['Epistaxis', 'Immune thrombocytopenia', 'Platelet count decreased']",UNK,PFIZER\BIONTECH, 1049750,MI,74.0,F,"1200 pt c/o lightheaded, vomit 1203. Rapid response. NP saw pt. VS, Bp 112/82, HR 58, o2 96% RA, @ 1209 to ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,UNK,,,"lexapro 10 mg qday, lisinopril qday",,nkda,"['Dizziness', 'Vomiting']",2,PFIZER\BIONTECH,IM 1049751,PA,36.0,F,"On 2/11/2021 Three days after getting the vaccine I started to have right arm pain similar to being punched. On this same day I began to feel as though my lips were very chapped, almost as I was dehydrated. As I drink 100 oz of water daily I knew this was not the case. I treated the lips with vaseline but did not see any outward appearance of a rash or redness. The arm pain lasted two days and the lip issue resolved approximately 5 days later. On 2/20/2021 after taking a shower, I noticed a red blotchy spot on my arm where the vaccine was given. It reminded me of a Polo Vaccine scar in approximately size, was red and raised in nature. I woke up on 2/21/2021 to about 3% of my upper right arm with a rash that was warm, swollen, and the outer edges of the rash we more red and raised versus the interior part of the rash. I went to my PCP on 2/22/2021 who was very concerned as he had not seen anything like this before. His best diagnosis was an adverse effect to the vaccine that had caused some form of Fungal Infection. I was given three medications in hopes of resolving the rash: Fluconazole 100mg, Prednisone 10mg, and Cephalexin 500mg. I was told to follow up with the office on Friday if the rash was still there or to make an appointment earlier if it got worse.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/11/2021,3.0,OTH,Levora-Birth Control Daily,none,None,,"Sulfa, Tramadol, Macrobid, Latex, Red Onions","['Chapped lips', 'Fungal infection', 'Injection site erythema', 'Injection site swelling', 'Injection site urticaria', 'Injection site warmth', 'Pain in extremity', 'Rash macular', 'Vaccination complication']",1,MODERNA,IM 1049752,VA,60.0,F,"Very lethargic, feverish, SOB",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,PVT,,,,,,"['Dyspnoea', 'Lethargy', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1049753,AZ,81.0,F,lump under injection site and rash down the arm to elbow,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,UNK,none,none,none,,penicilin,"['Injection site mass', 'Rash']",2,PFIZER\BIONTECH,IM 1049756,PA,65.0,F,"Urinary tract infection 48-72 hours after vaccine. Hematuria, with WBC's. Given course if Macrobid for 7 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/14/2021,3.0,PHM,"Levothyroxine, HCTZ, Metroprolol, Ezetimibe, Low dose ASA, Lisinopril, multi vitamin",Arrythmia,"Hypothyroidism, Hypertension, Arrhythmias, High cholesterol, Misty Mesentery,",,Amlodipine,"['Haematuria', 'Red blood cells urine', 'Urinary tract infection', 'White blood cells urine']",1,MODERNA,IM 1049757,AR,74.0,F,"Patient finished her 15 minutes wait and made her way the vehicle. Shortly after reaching the vehicle was feeling short of breath. Rapid response team from hospital came out and transported her to the emergency room. Most current nursing note as of 20 minutes ago, ""pt complains of chest pains sob difficulty swallowing and weakness. pt is AA+Ox 4 and has a room air sat of 98% rr of 22, hr of 71.""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PUB,"omeprazole, cholecalciferol, mometasone inhaler",asthma,asthma,,nkda,"['Asthenia', 'Chest pain', 'Dysphagia', 'Dyspnoea']",1,PFIZER\BIONTECH,IM 1049758,AZ,56.0,F,Swelling of eyelid and around the eye,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,OTH,none,none,none,,Erythromycin,"['Eye swelling', 'Swelling of eyelid']",1,PFIZER\BIONTECH,SYR 1049759,NY,61.0,M,"Headaches, fatigue, body aches. Symptoms subsided within 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/10/2021,1.0,UNK,"Multivitamin , Calcium tablet and Omeprazole 40mg",None,None,,None,"['Fatigue', 'Headache', 'Pain']",UNK,MODERNA, 1049760,CA,48.0,F,"nervous cold chills, swelling of the arm, pain in all muscles, joints and bones, headache, sudden change of mood/depression, buzzing in ears, weakness,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,OTH,,,good,,aspirin,"['Arthralgia', 'Asthenia', 'Bone pain', 'Chills', 'Headache', 'Mood swings', 'Myalgia', 'Nasopharyngitis', 'Nervousness', 'Peripheral swelling', 'Tinnitus']",1,MODERNA,SYR 1049761,WI,36.0,F,I have a red circle below my injection site that is sore and tender. It is also very warm and itchy. All I have tried so far is hydrocortisone cream.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/22/2021,4.0,PUB,Venlafaxine ER,none,None,,Sulfa and Ceclore,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 1049762,MD,42.0,M,"Patient states that the following morning he began to experience side effects of Chills, Fatigue, Body Aches, and Dizziness. After 5 days with no relief, he proceeded to urgent care and spoke with his PCP. They have tested him with both a Rapid and a regular COVID test and both were negative. He has never had a fever. They have tried various treatments, but he is still having these symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,MIL,None,None,None,,Penicillin,"['Chills', 'Dizziness', 'Fatigue', 'Pain', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 1049763,SC,69.0,F,"Red, itchy at vaccination site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/23/2021,10.0,PHM,Lexapro Levoxyl Vitamin D,None,None,,Sulfa,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,SYR 1049764,CA,67.0,F,"Itchy, red rash and swelling around vaccinated area. Occured seven days ( 2/22/21) after vaccination. Area warm. Treating with ice pack to control the itchiness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/15/2021,02/22/2021,7.0,PHM,"Metformin ER 500 mg; Rosuvastatin 5 mg; ; fish oil 1000, CQ10 300 mg, Multivitamins, turmeric Aspirin",none,Diabetes type 2,,Aspirin,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",UNK,MODERNA, 1049765,MD,54.0,F,"Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with diminish flow, tingling of the lips and tongue, pressure, tightness and pain in the chest. shortness of breath, right sided weakness and tingling of limbs and face. 50 ml of Benadryl, and 2 shots of epinephrine was given before transported to the Emergency Room via Ambulance On 2/22/2021 was sent to Urgent Care with the same symptoms. Urgent care sent me back to the Emergency room with heart arrythmias, chest tightness, tingling of lips and tongue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/16/2021,0.0,PVT,"amlodipine, rosuvastatin, pantoprazole,","History of Breast Cancer, GERD, IBS","History of Breast Cancer, GERD, IBS",,"shellfish, raspberries, cashews, tobraDex, bacitrian,","['Angiogram', 'Arrhythmia', 'Chest X-ray', 'Chest discomfort', 'Chest pain', 'Dyspnoea', 'Electrocardiogram', 'Hemiparesis', 'Palpitations', 'Paraesthesia', 'Paraesthesia oral', 'Swelling', 'Swollen tongue']",2,PFIZER\BIONTECH,IM 1049766,IN,74.0,M,"Three days after injection, patient felt he could not think clearly. Four days after injection he experienced tremors involved his arms and head and upper body. These tremors lasted about 48 hours then went away.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/25/2021,3.0,PUB,Cymbalta Donepezil. Amiodarone Atorvastatin. Clonazepam. Xarelto Aspirin Vitamin D. Melatonin. Vitamin B12 Fish oil Docusate sodium Dr Amen?s Memory Boost,,Parkinsonism,,Penicillin,"['Head titubation', 'Mental impairment', 'Tremor']",1,MODERNA,SYR 1049767,IL,82.0,M,"Discussed with ER provider last night about this patient. The abdominal findings and mild elevation of WBC gave us a hope to manage it with antibiotics alone because of his age, COPD, AAA. He was admitted to be kept NPO, and IV Zosyn was started. The understanding was to reassess the patient this morning and make appropriate decision � Surgeon's H&P 1/10/21, Admitted from ER: Admitted with sudden onset of right lower abdominal pain started yesterday morning. Not associated with vomitings, diarrhea, fever Was seen in ER last night WBC 13K and CT scan showed appendicitis with multiple appendicoliths. This morning he is having pain, slightly worse. Not hungry WBC 11.3K. Afebrile",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/07/2021,01/10/2021,3.0,SEN,tylenol amlodipine aspirin furosemide hydrocodone lactobacillus magnesium gluconate memantine tamsulosin,,,,nka,"['Abdominal pain lower', 'Amylase', 'Aortic aneurysm', 'Appendicitis', 'Appendicolith', 'Atrial fibrillation', 'Bladder scan', 'Blood culture', 'Blood lactic acid', 'Chest X-ray', 'Computerised tomogram abdomen', 'Computerised tomogram abnormal', 'Culture urine', 'Decreased appetite', 'Diarrhoea', 'Differential white blood cell count', 'Electrocardiogram', 'Full blood count', 'Lipase', 'Metabolic function test', 'Pain', 'Peritonitis', 'Prothrombin time', 'Pyrexia', 'Scan with contrast', 'Urine analysis', 'Vomiting', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1049768,CA,43.0,F,"at 1430, pt. states she felt warm, went to screening station, temp was 99.5, went back to desk and felt warm. States she started feeling pressure and warmth to her face with some itching. At 1500 she came to employee health. RN gave her 25 mg liquid benadryl. Her BP was 126/89, HR 87. No hives or swelling to Right arm noted. BP 117/80, HR 75. at apprx 1520, bp 137/85, HR 67. No other signs or symptoms noted. 1528, bp 121/82 At 1532, ""patient states she feels good, almost back to normal"".",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PVT,Multivitamins,"Dizziness, tooth pain",None,,None,"['Body temperature increased', 'Discomfort', 'Feeling hot', 'Pruritus', 'Tuberculin test']",2,PFIZER\BIONTECH,IM 1049769,MA,42.0,F,"On the third night after I received my second Moderna Vaccine , I broke out in hives under my breasts . I had nothing out of the ordinary , just the vaccine. I took benedryl for 2 days and then they were gone. I did not seek medical treatment .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/21/2021,4.0,PVT,Omeprazole 40 mg 1 x a day Valium 5mg PRN Vicodin 5 mg PRN,None,Fibromyalgia,,Wellbutrin Kelflex Bactrim,['Urticaria'],2,MODERNA,IM 1049770,AK,70.0,F,about 8-9 hours after site injection a swelling about the size of small apple accoured. kind of round and slightly SLIGHTLY red. this morning swelling less but injection site tender,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,UNK,lisinopril 5 mg estridol 1mg,none,overweight,,"sulfa, codine, diflucan, macrobid","['Injection site erythema', 'Injection site pain', 'Injection site swelling']",UNK,MODERNA,IM 1049771,UT,89.0,F,"Large (2""x3"") red splotch at region of injection. Tender and warm to touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/19/2021,14.0,PUB,Thyroxine Tabs - 100mcg: Lipitor - 10 mg Triamterine/HCTZ-50/25mg,none,none,,none,"['Injection site erythema', 'Injection site pain', 'Injection site warmth']",UNK,MODERNA, 1049773,GA,51.0,F,Patient died on 02/20/2021. Cause of death was pulmonary embolism.,Yes,,Not Reported,Not Reported,,Not Reported,,02/12/2021,,,PUB,unknown,unknown,unknown,,none listed on consent form,"['Death', 'Pulmonary embolism']",1,MODERNA,IM 1049774,TX,51.0,M,"AFTER 2 WEEKS (14 DAYS) FROM MY COVID MODERNA ADMINISTRATION VACCINE DATE , I NOTICED SUDDEN ERECTILE DYSFUNCTION AND ONGOING. I HAD NO ISSUES BEFORE THIS EVENT. THE ONLY MEDS ADDED WAS VIT D2 50,000 UNIT/WEEK IN THE LAST 2 WEEKS. I WAS SEXUALLY ACTIVE AND NO ISSUES WITH ERECTION PAST DAYS AND YEARS.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/20/2021,16.0,UNK,"LOSARTAN/HCTZ 100/12.5, SIMVASTATIN 20MG, METFORMIN ER 500MG, VIT D2 50K",,"DIABETES, BLOOD PRESSURE, LOW VIT D, HYPERCHLOESTERMIA",,,['Erectile dysfunction'],1,MODERNA,IM 1049775,CA,76.0,M,"Date/time of event reported by patient: 02/23/21, 09:00AM, patient reports to healthcare center and reports ""gradual psychotic episode"" one week following vaccine administration; denies effects today. 03/23/21 11:15AM: Phone communication with RN: Patient is at home, stable, in no distress. Patient reports after receiving his first dose of the Moderna vaccine, he shortly started noticing ""gradual psychoactive effects,"" that he describes as ""it just drove me mad."" Patient reports ""effects wore off now."" Denies concerns/effects today.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,02/06/2021,7.0,PVT,no,no,HTN,,no,['Psychotic disorder'],1,MODERNA,IM 1049776,NJ,70.0,M,"For the first time ever my pulse was erratic, going from 47 to 155. Then on 2/15, pulse was again erratic, and EKG showed AFib. Never happened before, no history",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/28/2021,9.0,PUB,Metoprolol 50mg/daily,"hemophilia A, and mono","hemophilia A, small aortic aneurysm",,strawberries,"['Atrial fibrillation', 'Cardiac monitoring', 'Cardiac stress test', 'Electrocardiogram', 'Pulse abnormal']",UNK,MODERNA,IM 1049777,CA,87.0,F,"tiny rash on left side of stomach, and small amount on inner left forearm, very itchy. and itching still continues. I used Benadryl spray on it.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/15/2021,13.0,UNK,"Omeprozole, Memantine, Triamterene, Lisinopril, Venlafaxine, Trimethoprim, Ezetimibe, Montelukast, probiotic, Super B, CoQ10, Vitamin D3 Nucala injection q 4 wks,,Qvar inhaler, premarin cream",none,"asthma, IBS, high blood pressure, slight depression,",,"Seafood, animals, environmental trees, shrubs gluten","['Rash', 'Rash pruritic']",1,MODERNA,IM 1049778,PA,37.0,M,Early the morning after my arm swole with increased swelling and pain and I treated with OTC Tylenol,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/15/2021,1.0,PVT,"Gavipentin, Vit. D and C",no,no,,no,"['Pain in extremity', 'Peripheral swelling']",2,PFIZER\BIONTECH,SC 1049779,TX,25.0,F,"Arm pain (moderate), injection site redness, fatigue (mild)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/23/2021,1.0,PVT,"Sprintec, Lexapro, Wellbutrin",,,,,"['Fatigue', 'Injection site erythema', 'Pain in extremity']",1,MODERNA,SYR 1049780,VA,36.0,F,"Chills, body aches, lymph node swelling, headache, severe fatigue, purple bruise, swallowing issue",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/01/2021,02/01/2021,0.0,PVT,,,,,,"['Chills', 'Contusion', 'Dysphagia', 'Fatigue', 'Headache', 'Lymphadenopathy', 'Pain']",1,PFIZER\BIONTECH,IM 1049781,NY,74.0,F,right arm where shot was given began to be sore and then itch and when I looked at it there was a rash a few inches long and oval in shape. It is the 2nd day of the rash and it is the same in size and redness but not as itchy and some soreness.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/22/2021,8.0,PHM,Daily multiple vitamin for women over 50 (no iron) 400 IU Vitamin D every other day 250mg magnesium tablet 2 times a week 1 Tablespoon of Mineral oil at bedtime,sinus headache,none,,had bad reaction to penicillin as a teenager so not taken since bad reaction to Cipro taken for food poisoning in my 40s so will not take again,"['Injection site pain', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 1049782,FL,84.0,F,"Severe thrombocytopenia with epistaxis requiring hematology consultation, IVIG, and ultimately daily eltrombopag therapy to correct.",Not Reported,,Not Reported,Yes,16.0,Not Reported,Y,01/22/2021,02/03/2021,12.0,PVT,,Seen in ER for UTI on 1/17/21,"HTN, dementia, hypothyroidism",,,"['Epistaxis', 'Immunoglobulin therapy', 'Platelet count decreased', 'Thrombocytopenia']",1,PFIZER\BIONTECH, 1049783,VA,24.0,F,Mouth sores,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/18/2021,2.0,OTH,Sertraline 50 mg daily Lo loestrin fe daily Melatonin Multivitamin,,Medullary sponge kidney,,"Dairy, penicillin, latex",['Stomatitis'],2,PFIZER\BIONTECH,SYR 1049784,NJ,72.0,F,"2/18/21 itching at site, 2 circles one quarter and one silver dollar size, hot to touch and hard-2/20/21 circles grew to 3 inches and connected-2/22/21 top part of arm faded, turned hot and red/ covid arm- went back to dr. on 2/23/21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/18/2021,7.0,PVT,"Eliquis , zinc, vitamin d, pravastatin",,,,,"['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth']",1,MODERNA,IM 1049785,TX,27.0,M,Immediately post-vaccination patient had emesis x1 with nausea. Resolved with supportive management.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/23/2021,02/23/2021,0.0,PUB,,,,,,"['Immediate post-injection reaction', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 1049786,VA,69.0,F,"Sore arm, slight fever (100.6), fatigue, slight intestinal distress",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,"Escitalopram, vitamins, Allegra, citracal w/ D3",None,None,Sore arm,"Penicillins, ibuprofen, cephalosporins, clindamycin","['Abdominal discomfort', 'Fatigue', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1049787,CA,69.0,F,"Without showing any side effect symtoms, patient suddenly fell unconscious and passed away within an hour. Though 911 was called and Paramedic was trying to revive the patient.",Yes,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,UNK,None,None,High Cholastrol,,None,"['Death', 'Loss of consciousness']",2,MODERNA,SYR 1049788,AL,74.0,F,Patient has yellow discoloration on arm below the injection site and bruising around the area.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/19/2021,2.0,PHM,Unknown,Unknown,Unknown,,Unknown,"['Injection site bruising', 'Injection site discolouration']",1,MODERNA,IM 1049789,IL,56.0,F,"16 days after receiving the first dose of Modern, I experienced a painful inflamed rash on upperpart of my body including neck, back, chest, torso, ears, and hips. No other symptoms. I have not made any changes to soaps,medicines, diet, or other environmental triggers. I saw my doctor immediately and was prescribed a steroid pack to relieve the swelling and pain of the rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/23/2021,16.0,PVT,"Estradil .5 mghydroxychloroquine sulfate 200 mg, Biotin 5000 mcg Vitamin C 500 mg Vit D 400 IU Miralax as needed",None,None,,None,"['Rash', 'Swelling']",1,MODERNA,IM 1049790,AL,54.0,F,"Arm began itching on day 5 after injection. The itching progressed, became red around the injection site and the redness expanded down the arm (to the elbow) and around the arm front and back until it met at the bicep. This has lasted for 7 days so far.... It is much better but still a bit red and itching a small bit.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/16/2021,5.0,OTH,Premarin,none,none,,none,"['Injection site erythema', 'Pruritus']",1,MODERNA,SYR 1049791,NY,66.0,F,"On day 8 after first dose of Moderna, injection arm started itching . It was under the arm of the injection site. On day 9 injection site also became itchy, red and swollen and bigger than the day before. It feels hot and slightly painful. Day 10 the warmth went down but still itchy, red and feel a hard lump on injection site. Today is day 11 and still red and itchy but feels slightly better.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/20/2021,8.0,SCH,Rouvastatin 10mg Centrum Vitamin D 2000mg Baby Aspirin Alendronate 5mg Magnesium,,,,Apples,"['Injection site erythema', 'Injection site mass', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 1049792,IL,68.0,F,Developed stroke like symptoms with hypertension on 2/19/2021. treated on 2/22/2021 for bells palsy with left sided facial droop and severe hypertension at dr office.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/19/2021,2.0,PUB,Metformin levothyroxin,,Diabetes Mild Hypertension hypothydriodism,,,"[""Bell's palsy"", 'Facial paralysis', 'Hypertension']",1,MODERNA,IM 1049794,NE,86.0,M,"MORNING OF 2/17/21, DEVELOPED WEAKNESS, AND INABILITY TO STAND. GENERALIZED BODY ACHES AND PAIN, AND CONFUSION. WAS TRANSPORTED TO THE ER AND ADMITTED TO THE HOSPITAL.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/16/2021,02/17/2021,1.0,SEN,,,,,,"['Asthenia', 'Confusional state', 'Dysstasia', 'Pain']",2,PFIZER\BIONTECH,IM 1049795,MI,69.0,M,"Pain, swelling, extreme bruising at the injection site lasting 11 days. Injection site is still dark blue and swollen. Adverse effect happened right after the vaccine process.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,PHM,"Aspirin 81mg, carvedilol, glipizide, metformin, paroxetine, Tamsulosin.",No illness reported.,"Diabetes, hypertension, depression",,Bee Stings,"['Immediate post-injection reaction', 'Injection site bruising', 'Injection site pain', 'Injection site swelling']",1,MODERNA,IM 1049797,MD,67.0,F,"On 2/19/2021 Day 7 following the date of my first vaccination which was occurred on 2/12/2021, a delayed local reaction occurred with a 3'x4' red, raised, itchy, painful area appearing at the vaccination site on my L arm. On 2/19//2021 I also experienced repeat generalized symptoms: including repeat headaches. body aches & extreme fatigue since 2/19/21 including today, which is 2/23/2021. I did not have the pronounced local reaction at the vaccination site on my L arm initially after the vaccination. When I looked up the delayed reaction online I realized some others have experienced this delayed reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,PHM,,None,L breast cancer 2010h Hypothyroidism Atril Fibrillation,,percocet = hives betadine sol = hives,"['Fatigue', 'Headache', 'Injection site pain', 'Injection site pruritus', 'Injection site urticaria', 'Pain']",1,MODERNA,IM 1049798,CA,64.0,F,Swollen lymph nodes during MRI,Not Reported,,Not Reported,Not Reported,,Not Reported,,01/26/2021,02/18/2021,23.0,UNK,,,,,,"['Lymphadenopathy', 'Magnetic resonance imaging']",1,MODERNA,IM 1049799,OK,82.0,F,"I got got the vaccine at 10:47 AM on 2/1/2021. On the morning of the 5th I was itching. The on the 4th I have a lady who comes out to my house and helps me bath and she put gold bond lotion all over. I thought it was the lotion so I bathed again and got the lotion off my body. It is has since gotten worse and worse, I have little red spots on back, shoulders and arm. My shoulder has red bumps on it, looks like a rash and is rough feeling. The itching and spots are still there as of 2/23/2021. I spoke PA at my doctor's office and she called in a prescription Pepcid AC 20 MG (one a day) and Wal-zyr (generic Zyrtec ) on the 2/19/2021. I have also been putting some Hydrocortisone cream on it as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/05/2021,4.0,UNK,"Metformin 500 MG 3times a day, Gabapentin 300 MG 3times a day, Aspirin 81 MG daily, Pantoprazole 40MG daily, Magnesium 500 MG daily,",,"diabetes, knee surgery 2/13/2020",,"Penicillin, Excedrin, Benadryl","['Dry skin', 'Pruritus', 'Rash erythematous']",1,PFIZER\BIONTECH,SYR 1049800,OH,86.0,M,Patient came to mass vaccination clinic and received Moderna for second dose. Second dose should have been Pfizer.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/23/2021,0.0,PUB,,,,,None,['Interchange of vaccine products'],2,MODERNA,IM 1049801,VI,52.0,F,Recipient reports itching left arm and rash on left arm noted the day after receiving the vaccine. She added that the itching is gone and no new bumps have appeared.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/18/2021,1.0,PUB,"Vitamins D and C, Zinc, Magnesium and Calcium",None,Hypertension,,None,['Rash pruritic'],2,PFIZER\BIONTECH,IM 1049802,CA,87.0,M,"Fatigue, sleep, Ok after 4 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,OTH,"Benazepril, Eliquis",None,Atrial fibrillation,,None,['Fatigue'],1,MODERNA,IM 1049803,MO,53.0,F,"I woke up with severe shoulder/joint pain and weakness plus popping and cracking burning as well, in both arms left and right. Plus joint pain in hips. Still having. the same weakness and pain as of today on 2/23/2021.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/15/2021,01/16/2021,1.0,SEN,Mobic and albuterol,Rheumatoid Arthritis,Rheumatoid arthritis,,,"['Arthralgia', 'Burning sensation', 'Electrocardiogram', 'Joint noise', 'Muscular weakness', 'X-ray']",2,MODERNA,SYR 1049804,NY,75.0,F,"chills, fever, weakness, fatigue, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PHM,Eliquis 5mg 1 tab 2X a day Metropol ER 25mg 1 tab @ night Pravastatin 80mg 1 tab @ night Irbesartan 150mg 1 tab a day C-Pap,"A-Fib, Asthma",A-Fib,"senior flu - 2018, flu - same as with covid vacine","Calan Sr, Latex, Niasin, Tenorman, Iodine","['Asthenia', 'Chills', 'Fatigue', 'Nausea', 'Oral herpes']",2,MODERNA,IM 1049805,VA,56.0,M,"Light headache, dizziness, low blood pressure (100/64 mmHg)",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/05/2021,0.0,PVT,,,,,,"['Dizziness', 'Headache', 'Hypotension']",2,PFIZER\BIONTECH,IM 1049806,TX,67.0,M,"02/05/2021 PM onset of chills, extra tired, no fever; 02/06 - nausea, low grade fever, and extra tired , moderate not severe; 02/07- generalized crimson body rash, did not itch; 02/08 Improved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/05/2021,1.0,OTH,,None,,,Penicillin,"['Chills', 'Fatigue', 'Nausea', 'Pyrexia', 'Rash erythematous', 'SARS-CoV-2 test negative']",2,MODERNA,IM 1049807,IL,78.0,F,"1/12/21 er HPI: HPI 78 y.o. female who presents with pain swelling and redness left wrist and hand associated with fever according to EMS, but temperature in the ER is 98.4� F. patient was said to have fallen on 1/7/2021. *incidental finding bacterial pne* � 1/12/21 admission History: The patient is a 78 y.o. female with a past medical history notable for Dementia, atrial fibrillation, CHF, diabetes, reflux. The patient presents for evaluation of Worsening issues of decline and trouble with breathing. Patient was evaluated the ER and found to have a urinary tract infection in addition to pneumonia. Due to patient's dementia history is difficult to take outside of history of which was taken for patient's nursing staff at skilled care facility. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/03/2021,01/12/2021,9.0,SEN,Current Outpatient Medications on File Prior to Encounter Medication Sig Dispense Refill ? albuterol-ipratropium (DUO-NEB) nebulizer solution Take 3 mL by nebulization every 12 hours as needed for Shortness of Breath � � ? ALPRAZolam (XAN,12/29/21 Pneumonia Left lower lobe due to infectious organism; Acute on Chronic systolic heart failure,,,Allergies Allergen Reactions ? Cafergot Other/Unknown (See Comments) ? Caffeine Other/Unknown (See Comments) ? Ergotamine Other/Unknown (See Comments) ? Lisinopril � ? Rythmol [Propafenone] Other/Unknown (See Comments) ? Tonocard [Tocainide] � �,"['Asthenia', 'Blood culture', 'Blood lactic acid', 'Blood potassium', 'Chest X-ray', 'Computerised tomogram head', 'Differential white blood cell count', 'Dyspnoea', 'Erythema', 'Fall', 'Full blood count', 'Metabolic function test', 'Pain', 'Pneumonia bacterial', 'Pyrexia', 'Swelling', 'Urinary tract infection', 'Urine analysis', 'X-ray limb']",1,PFIZER\BIONTECH,IM 1049808,CO,42.0,F,Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported itching and injection site redness. Vital signs within normal ranges except heart rate 102 beats per minute. Patient administered oral diphenhydramine and observed. Symptoms improved and repeat vital signs all within normal ranges. Patient was discharged from vaccine clinic stable with symptom improvement.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,"amlodipine, losartan",None reported,None reported,,None reported,"['Injection site erythema', 'Pruritus']",1,PFIZER\BIONTECH,IM 1049809,OH,84.0,F,Patient attended mass vaccination clinic and received Moderna as second dose. Patient should have received Pfizer for second dose.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/23/2021,0.0,PUB,,,,,,['Interchange of vaccine products'],2,MODERNA,IM 1049810,MI,70.0,F,fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,SEN,"Zoloft, Latuda, Potassium, Atorvastatin Calcium Tablet,Ergocalciferol Tablet 50 MCG (2000 UT) ,Oyster-Cal 500 Tablet (Calcium)",no,"a-fib, nuscle wasting and atrophy, hx covid 19, weakness, gerd, insomnia , morbid obesity, psychosis, major depressive disorder, anxiety disorder, htn, atherosclerotic heart disease, acute ischemic heart disease, oa, palpations,",,lactose,['Pyrexia'],2,MODERNA,IM 1049811,TX,65.0,F,"Bright red itchy and painful rash at injection site, started about 12 after injection and remained for 1 week. Size from shoulder to below elbow.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/12/2021,1.0,PVT,,,,,,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 1049812,NJ,74.0,M,"Patient c/o fever, headache, myalgias, weakness on 2/4/2021. Presented to ED 2/6/2021 with above symptoms and shortness of breath.",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,01/29/2021,02/04/2021,6.0,OTH,"Airduo, atorvastatin, basaglar, Humalog, Januvia, montelukast, albuterol, pantoprazole, vitamin B12",,"Diabetes mellitus type 2, CKD, COPD",,None,"['Asthenia', 'Chest X-ray abnormal', 'Dyspnoea', 'Headache', 'Myalgia', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1049813,MA,67.0,M,"Felt Dizzy, plus rapid heartbeat, tightening of throat, muscle soreness and fatigue. Symptoms occurred 45 minutes after injection. Symptoms lasted about 90 minutes. Did lay down for 15 minutes which helped.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,OTH,"Hydrochlorothiazide, 25mg, once per day Lisinopril IC, 5mg, 0nce per day Potassium Chloride ER, 10 meg, once per day Pantoprazole, 40mg, once per day Atorvastatin, 40mg, once per day Sertraline HCL, 50mg once per day",None,Psoriasis High blood pressure,,"Cefaclor, Augmenting, Hydrocodone, Norvasc Seasonal grass allergies","['Dizziness', 'Fatigue', 'Heart rate increased', 'Myalgia', 'Throat tightness']",1,PFIZER\BIONTECH,SYR 1049814,WI,90.0,F,Stroke confirmed on MRI.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/09/2021,02/10/2021,1.0,PVT,"thyroid extract, aspirin, myrbetriq, triampterien-htct,calcium",none,none,,sensitive to statins,"['Cerebrovascular accident', 'Computerised tomogram head abnormal', 'Echocardiogram normal', 'Magnetic resonance imaging brain abnormal']",1,MODERNA,IM 1049815,TX,52.0,F,Burning itchness all over body,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PVT,"Prednisone, Florinef, Metformin, Synthyroid, Verapamil",None,"2nd Adrenal insufficiency, Hypothyroidism, Pulmonary Embolism, Migraines, Diabetes Type II, Adult ACTH, peripheral neuropathy",,"Moxifloxacin, Avocados, Mangos","['Burning sensation', 'Pruritus']",2,PFIZER\BIONTECH,IM 1049816,SC,68.0,F,"Fever, chills, fatigue, ache, at injection site minor soreness. This went on for about 32 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PVT,Simvatatin. Vitamin D3. Benadryl 2 teaspoon. Allergy shots 2 per week. Last taken 48 hours before covid shot,None,"Hasimotois disease, arthritis, vitiligo, allergies, I have only one functioning kidney",,Yes. Some antibiotics but food sensitivities only due to environmental allergies. I have many of those.,"['Chills', 'Fatigue', 'Injection site pain', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 1049817,MI,62.0,F,"Heart flutters , sore arm , trouble sleeping",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,UNK,Atenolol /chlorthalidone,None,"High blood pressure, boarder line diabetes",,"Bee, somebody, some nut","['Cardiac flutter', 'Insomnia', 'Limb discomfort']",1,MODERNA,SYR 1049818,TX,65.0,F,"Headache within 2 hours of injection, and flu like sym, chills, fever, muscle and joint aches for 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,PVT,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Influenza like illness', 'Myalgia', 'Pyrexia']",2,MODERNA,IM 1049819,CA,56.0,M,"Patient developed lower extremity weakness, the weakness progressed and after few days he was not able to walk even with help of crutches. Guillain barre syndrome was suspected. He was sent to hospital. Lumbar puncture was performed on him showed elevation of CSF protein. He received IVIG and his weakness improved. He also received Vitamin B12 injection due to Vitamin B12 deficiency",Not Reported,,Not Reported,Yes,7.0,Not Reported,Y,01/20/2021,01/21/2021,1.0,OTH,"acetaminophen 325 mg Tab (Tylenol) 650 mg 2 tab Oral TID PRN: pain capsaicin 0.025% Cream 60 gm (capsaicin 0.025% topical cream) 1 app Topical Daily cholecalciferol 2,000 unit Cap (Vitamin D3) 2,000 unit 1 cap Oral Daily clotrimaz",DM HTN Chronic kidney disease,DM HTN Chronic kidney disease,,Penicillin,"['CSF protein increased', 'Gait inability', 'Guillain-Barre syndrome', 'Immunoglobulin therapy', 'Magnetic resonance imaging spinal abnormal', 'Muscular weakness', 'Vertebral foraminal stenosis', 'Vitamin B12 deficiency']",1,MODERNA, 1049820,VA,73.0,F,Patient received Moderna vaccine for first dose and then Pfizer for second dose,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/16/2021,0.0,PVT,Claritin/ Singulair,,Osteoarthritis,,Celebrex,['Interchange of vaccine products'],1,PFIZER\BIONTECH,IM 1049821,MD,47.0,F,Onset of migraine visual aura and nausea. Migraine headache did not occur while the patient was under our observation. Patient thinks the aura may have been triggered by bright lights in observation room. No medications given.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PUB,None,Migraine HAs,Migraine HAs,,History of anaphylaxis to tree nuts,"['Migraine with aura', 'Nausea']",1,PFIZER\BIONTECH,IM 1049822,OK,66.0,F,dizziness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/08/2021,3.0,OTH,"oxybutynin vitamin d3, multivitamin, vitamin c, collagen",,leukemia,,,['Dizziness'],2,PFIZER\BIONTECH,SYR 1049823,TX,60.0,M,Mild flu like sym. that started approx. 8 hrs after injection and lasted approx. 8 hrs.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,PVT,,,,,,['Influenza like illness'],1,MODERNA,IM 1049824,AZ,85.0,F,My arm is swollen and red.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/23/2021,3.0,PUB,"eliquis, irbesartan, amalodipine, multivitamin, omega 3 6 9, super B complex, caltrate, vitamin C,",none,Afib I have a pace maker also have osterperosis,,"tetnus, metropolol, latex","['Erythema', 'Peripheral swelling']",UNK,PFIZER\BIONTECH, 1049825,VA,38.0,F,Stiffness in the left shoulder,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,PVT,,,,,,['Musculoskeletal stiffness'],UNK,PFIZER\BIONTECH,IM 1049826,TX,36.0,F,"Adverse Events: Slight Fever, pain at injection site, fatigue, muscle pain Treatment: acetaminophen Outcome: symptoms lasted 4 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,UNK,Labetalol,,Hypertension,,"Coffee, ibuprofen, OxyContin","['Fatigue', 'Injection site pain', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 1049827,TX,27.0,F,"Nausea, fever, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,PVT,,,,,,"['Myalgia', 'Nausea', 'Pyrexia']",2,MODERNA,IM 1049828,NJ,38.0,M,"Horrible chills that night starting at 2am, along with body and muscle aches in both arms and shoulders. Next day the muscle aches were all over but not as bad, but a severe headache all day. Treated with tylenol all day along with ibuprofen + tylenol at night. The next day I felt fine, however noticed a baseball sized lump under my left armpit about 60 hours after the shot in my left shoulder. Internet says it's a swollen lymph node and known side effect. The next morning the swelling went down significantly and after another day it seems to be getting better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PUB,"rosuvastatin 5mg 3/week, coQ10 200mg/day, tadalafil 5mg/day",,,,,"['Chills', 'Headache', 'Injection site mass', 'Pain']",2,PFIZER\BIONTECH,IM 1049829,CA,75.0,F,"Vaccination site presented with rash, itching, and warmth 48 hours after injection. Rash size diameter of approx. 4.0 inches; Itching, warmth, and redness is disappearing, beginning February 23, 2021. No other adverse affects noted. Husband (age 80) received the same dosage at same time with no adverse symptoms to date. Patient (Reporting Party ) is a Licensed Registered Nurse.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/20/2021,2.0,OTH,None,None,None,,Levofloxacin,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",2,MODERNA,IM 1049831,CA,68.0,M,"Pain and inflammation in left knee starting at about 7:30pm on 2/22/2021. Chills starting at 11:30pm on 2/22/2021 Knee was bright red by 12:00am 2/23/2021. Hydrocodone 5mg-acetaminophen taken at 8:30 pm. No relief. Oxycodone-Acet. 5mg taken at 11:30 pm pain worse, no relief. By 2:30am considering ER. 2:30am took 2 Prednisone 10mg tablets, and 1 Ketrolac 10mg. Pain relief within 20 minutes. By 8:00am 2/23/2021 knee pain was gone. Did notice burning urination at that time, but none since. by 12:00pm 2/23/2021 mild fatigue but no pain or inflammation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PVT,"lisinopril, atenolol, atorvastatin, 162mg aspirin, glucasomine/condroitin, adult multivitamin, grapeseed resveratrol taken at approx 9:00am day of vaccination",,"psoriatic arthritis, osteoarthritis, coronary artery disease",,penicillin,"['Arthralgia', 'Chills', 'Dysuria', 'Erythema', 'Fatigue', 'Joint swelling']",2,MODERNA,SYR 1049832,FL,25.0,M,"I began to feel ill in bed. I stood up to get some water. While pouring the water, I felt much worse - out of it. I dropped the cup but it didn't register with me. I tried pouring again but dropped the pitcher too. My girlfriend came out, woken up by the noise, and then saw me collapse and start shaking. I don't remember anything after dropping the pitcher. When I came to (maybe a few seconds later?), I asked if I hit my head. She said I hadn't (luckily she was there to catch my head) but I did urinate on myself. I was very cold shivering, teeth clattering. She got me over to the shower where I turned the temperature all the way up and sat underneath. After a while I began to feel better - the fog had cleared for sure. I got in bed after and slept it off. When I woke up I had sweat through my clothes and still had a mild fever, but aside from that I felt almost entirely better. It's been about two days since then and I still feel completely well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,UNK,Finasteride,None,None,,Dust,"['Chills', 'Malaise', 'Nasopharyngitis', 'Night sweats', 'Pyrexia', 'Syncope', 'Tremor', 'Urinary incontinence']",2,MODERNA,SYR 1049833,CA,75.0,F,"Red arm, rash 3 x 3 inches at injection site, very warm to the touch, itchy. Normal after four days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/18/2021,16.0,PVT,"Losartan, Atorvastatin, Calcium, Centrum Silver women 50+, Vitamin D3",none,,,Penicillin,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,MODERNA,IM 1049834,OH,32.0,F,swelling at base of neck on left side,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/23/2021,3.0,PUB,"nuva ring, zyrtec",none,none,,"skelaxin, environmental/seasonal",['Swelling'],2,PFIZER\BIONTECH,IM 1049835,OH,49.0,M,Patient developed R sided Bell's Palsy approximately 10 days after vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/16/2021,12.0,SCH,"Pantoprazole, bupropion, citalopram, fenofibrate, losartan, atorvastatin, Trulicity, Toujeo, metformin",,"DM2, HTN, hyperlipidemia, depression, OSA, morbid obesity",,NKDA,"[""Bell's palsy""]",UNK,PFIZER\BIONTECH,IM 1049837,NY,21.0,F,"Hives all over my face and ears, onset 7 days post-vaccination, on and off for four days so far, on different parts of the face",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/20/2021,6.0,UNK,"vitamin c supplements, tyenol, birth controll",none,none,,"tomato, cooked tuna, environmental",['Urticaria'],2,MODERNA,IM 1049838,VA,36.0,F,Unknown,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,PVT,,,,,,['Unevaluable event'],UNK,PFIZER\BIONTECH,IM 1049839,CT,67.0,F,Rash hot itchy dry 7 days later,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/20/2021,8.0,PHM,Synthroid,No,No,,No,"['Feeling hot', 'Pruritus', 'Rash']",1,MODERNA, 1049840,CA,66.0,F,"Chills, feeling cold",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,OTH,"Omeprazole, sertraline, artovastatin, vitamin e, glucosamine, calcium, ginko biloba,",None,Arthritis,,Shellfish,"['Chills', 'Feeling cold']",2,PFIZER\BIONTECH,IM 1049841,,,U,"Evening of injection 2/16/21: arm pain, headache, feverish, flu-like feeling, lethargy. Next day and on and off on days since: gastrointestinal discomfort, loose bowel movements, lethargy, occasional headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Abdominal discomfort', 'Diarrhoea', 'Headache', 'Influenza like illness', 'Lethargy', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1049842,AL,75.0,M,"Severe arthralgia-difficult walking-disoriented, fever, headache-gradually improved over 48 hr period",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/16/2021,1.0,PHM,"Crestor,omeprazole,Wellbutrin, met form in, atenolol,amlodopine,prozac,fenofibrate, ASA Vitamin D",Pneumonia in December 2020,Hi of coronary bypass surgery 1999 Type 2 diabetes Hi of depression,,None,"['Arthralgia', 'Disorientation', 'Gait disturbance', 'Headache', 'Pyrexia']",2,MODERNA,SYR 1049843,WI,48.0,F,"Within 10 mins flush face felt dizzy within 6 hours started to feel flu like symptoms. Still feel awful and at day 6. Went to ER and doc. High blood pressure, very bad headaches, anxious, stomach issues, tired and overall cannot function",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/17/2021,16.0,PVT,Warfarin adderal ambien bystolic wellbutrin,None,"Blood clotting disorders, breast cancer 5 yrs out, insomnia,",,Pencillen,"['Abdominal discomfort', 'Anxiety', 'Dizziness', 'Electrocardiogram normal', 'Fatigue', 'Flushing', 'Headache', 'Hypertension', 'Influenza like illness', 'Ultrasound scan normal']",2,MODERNA,SYR 1049844,MN,40.0,F,started with a red rash and then kind of itchy warmness in my back lasted about two days and then today my left arm looks like covid arm and red circle with a spot that looks like raw skin and a blisters next to it,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/05/2021,6.0,PUB,Yes,NO,No,,,"['Blister', 'Pruritus', 'Rash erythematous', 'Skin warm']",1,MODERNA,SYR 1049845,NV,78.0,F,"12 hrs after vaccination, pt reported mild tightness in throat and mild swelling of upper lip",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PVT,,,,,,"['Lip swelling', 'Throat tightness']",UNK,MODERNA, 1049846,CA,46.0,F,Blotchy slightly raised rash on left arm in area of the injection site. Mildly itchy and warm to the touch,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/13/2021,02/23/2021,10.0,MIL,"Clomipramine, bupropion, levothyroxine, omeprazole,azathioprine, cholecalciferol, vitamin c, zinc, Tylenol extra strength, Tramadol.",,"Sj�gren?s syndrome, gastritis, herd, hypothyroidism, hx diabetes type 2, neuropathy, chronic pain, ocd, anxiety, mdd",,"Plaquenil, etodolac, risperidone, olanzapine, geodon","['Injection site pruritus', 'Injection site urticaria', 'Injection site warmth']",1,MODERNA,IM 1049847,KS,49.0,F,Swollen lymph nodes in arm pit of left arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/23/2021,1.0,WRK,,,,,,['Lymphadenopathy'],2,PFIZER\BIONTECH,SYR 1049848,,75.0,F,"Patient called stating she received the second Pfizer vaccine on 2/21. That evening, she developed severe generalized weakness. She was unable to walk or stand. She laid on the floor from 2/21 3pm until 2/22 PM. She was incontinent of urine- reports urinating on towels throughout yesterday. She was unable to hold her head up due to weakness. She still feels weak today, but is able to stand and walk with husband's assistance. Also reports generalized muscle soreness and intermittent vertigo. She is drinking fluids well, has eaten a light meal today. Denies fever, shortness of breath, chest pain, palpitations.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,UNK,,,,,,"['Discomfort', 'Gait inability', 'Muscular weakness', 'Urinary incontinence', 'Vertigo']",UNK,PFIZER\BIONTECH,IM 1049849,FL,61.0,F,Temporary inflammation of lips. Had filler (Juvaderm) 12 months prior to vaccine. Symptoms lasted only 3 or 4 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/16/2021,15.0,PVT,,,,,penicillin,['Cheilitis'],1,MODERNA,IM 1049850,FL,87.0,M,"Altered mental status, confusion, nausea vomiting, acute metabolic encephalopathy",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,02/16/2021,02/18/2021,2.0,PVT,,,"Parkinson's, panhypopituitarism, chronic kidney disease, Addison's disease, osteoarthritis.",,,"['Confusional state', 'Mental status changes', 'Metabolic encephalopathy', 'Nausea', ""Parkinson's disease"", 'Vomiting']",1,MODERNA, 1049851,,51.0,F,"Dry cough, shortness of breath, Headache, fatigue,",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/22/2021,2.0,UNK,"Vitamins, Iron and Cholestorl medicen Astrostatin 10mg",No,No,,No,"['Cough', 'Dyspnoea', 'Fatigue', 'Headache']",2,MODERNA,SYR 1049852,AZ,71.0,M,When calling to get billing information we were notified that patient had passed away. Patient's daughter said patient was having cvd a/s on 2.1.2021 got vaccine 2.2.2021 and passed away 2.5.2021. Cardiologist said not related,Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/05/2021,3.0,PHM,vitamin d 1.25 mg 1 per week,,cvd,,none,['Death'],1,MODERNA,IM 1049853,PA,59.0,F,pt stated that she had some pain in left arm on 2/21/2021 that went away. Then she developed swelling in the left arm on 2/22/2021. On 2/23/2021 she noticed a red patchy ring around the injection site. Pt called the medical clinic which told her to call us.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/23/2021,13.0,MIL,"losartan, metoprolol, calcium, Vitamin D, perphenazine, lorazepam, multivitamin, Tylenol,",no,one working kidney (UPJ obstruction in the right kidney) HBP,,"sulfa and resperadol,","['Injection site erythema', 'Injection site rash', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 1049854,MD,64.0,F,"Chills, fever, fatigue, nausea, vomiting, headache, started the next day, persisted for 2 days, gradually improving , no treatment aside from tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,OTH,"Hydrocortisone, levothyroxine, xyzal, singulair",None,"2ndary adrenal insufficiency, asthma",,Dilantin,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",2,MODERNA,SYR 1049855,OR,37.0,F,"When I woke up the next morning after receiving the vaccine, my entire body hurt. -Achy muscles -Skin sensitivity -Excessive tiredness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PUB,"Oral birth control, Celexa",,Hemochromatosis,,Penicillin,"['Fatigue', 'Myalgia', 'Sensitive skin']",2,MODERNA,SYR 1049857,NC,64.0,F,"2/14: The day after receiving the vaccine, she noticed a rash on her chest and legs. She felt nauseous and endorsed vomiting, body aches, and fever. 2/16: Saw PCP and was found hypotensive. Was sent to ED and received 2L fluids, IM steroids, and PO ondansetron. She was discharged because she was feeling better. 2/17: Returned to hospital due to pleuritic chest pain and hemoptysis and was noted to have an elevated lactate (received 3L fluids) and was admitted to the hospital. SpO2 was in the 70s on presentation and she was placed on BiPAP (O2 improved to 100%). Per note: patient presented to the ED with hypoxia, tachycardia, tachypnea, and leukocytosis. Patient received dexamethasone 6mg, vancomycin, cefepime, azithromycin, furosemide, and ipratropium/albuterol. Patient is currently receiving the following medications: budesonide, ipratropium/albuterol, cefepime, acetaminophen, atorvastatin, benzonatate, enoxaparin, escitalopram, ferrous sulfate, guaifenesin, hydrocodone/acetaminophen, methylprednisolone, methylprednisolone, Montelukast, morphine, ondansetron, pantoprazole. Patient has been hospitalized since 2/17",Not Reported,,Yes,Yes,,Not Reported,N,02/13/2021,02/14/2021,1.0,PVT,Albuterol Apixaban Benzonatate Budesonide Escitalopram Famotidine Fexofenadine Lisinopril/HCTZ Montelukast Pantoprazole Simvastatin Triamcinolone ointment,Prior history of COVID-19 pneumonia reported in April/May 2020 (6-week intubation),"HTN, prediabetes, hypercholesterolemia, gastritis",,None reported,"['Bilevel positive airway pressure', 'Blood immunoglobulin M', 'Blood lactic acid increased', 'Blood pH normal', 'Chest pain', 'Fibrin D dimer increased', 'Haemoptysis', 'Hypotension', 'Hypoxia', 'Leukocytosis', 'Nausea', 'PO2 decreased', 'Pain', 'Platelet count increased', 'Pleurisy', 'Pleuritic pain', 'Pyrexia', 'Rash', 'SARS-CoV-2 antibody test positive', 'Tachycardia', 'Tachypnoea', 'Vomiting', 'White blood cell count increased']",1,MODERNA,IM 1049858,IL,53.0,F,"Arm got red, itchy, sensitive and sore, slightly discolored. Lasted about 3-4 days and has since resolved",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/20/2021,8.0,PHM,vitamin d,,diabetes,,eggs - migraines,"['Erythema', 'Pain in extremity', 'Pruritus', 'Sensitive skin', 'Skin discolouration']",1,MODERNA,IM 1049859,WA,46.0,M,"Headache, fever, muscle ache, and weakness throughout the body",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,02/22/2021,52.0,PUB,"500mg Tylenol, 600mg ibuprofen,","Fever(temperature exceeds 100.9), headache, muscle aches, weakness throughout the body.",None,,None,"['Asthenia', 'Headache', 'Myalgia', 'Pyrexia']",2,MODERNA,SYR 1049860,TX,60.0,F,"I received my second Moderna vaccine on 2/05/2021. Within 10 minutes of receiving the vaccine I got a real bad headache, was very dizzy and felt very hot all inside my body. I reported it to the nurse and she told me it was a normal reaction to the vaccine and to wait a little longer than the 15 minutes to see if it would go away. She gave me water and I did fell better and we left medical center. At around 5:30 pm that same day I started to get cold chills and body aches especially on my right side. my lower back and my right hip were hurting a lot and I was having trouble walking.at around 8:00 pm my husband notice my right foot was very swollen and I notice by breast, my arm and hand, my underarm and leg were extremely swollen and painful. I did take a Tylenol because that is what they told me to take. I was freezing cold by the time I went to bed during the night I was sweating a lot. As of that day my symptoms were: Swelling on my right side Body aches, Headaches Fever Difficulty breathing/Shortness of Breath Rapid heart rate ranging from 100-125 w/o doing anything My neck and throat were very swollen around my thyroid area Blurring vision Chills and hot flashes Fatigue/Malaise Big round red welt around my injection site about 4 inches wide and hot to the touch I finally called medical center on 2/18/21 because I still had right leg, hip pain and swelling. I had a tele-med appointment with one of their doctors and she told me I had to first get a Covid-19 test to see if I didn't have Covid. Which the test did come out negative. She also told me that maybe the vaccine triggered something in my body that was causing all the swelling. I do have an appointment for chest, hip spine x-ray and lab work for 3/22/21. I still have the hip pain but not as bad. The person who gave me my Covid test results said I should report my symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,PUB,"Thyroid medication CMPD T3 22MCG/T4 76MCG, Telmisartan 40 mg, low dose Aspirin, Vitamin D3, Vitamin B12, Magnesium, Vitamin C, Amberen",Thyroid problems and High blood pressure that is under control,None,"With first dose I just had body aches, headaches and fatigue.",Codiene,"['Breast pain', 'Breast swelling', 'Chills', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Feeling cold', 'Feeling hot', 'Gait disturbance', 'Headache', 'Heart rate increased', 'Hot flush', 'Injection site erythema', 'Injection site warmth', 'Malaise', 'Night sweats', 'Oedema peripheral', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pharyngeal swelling', 'Pyrexia', 'SARS-CoV-2 test negative', 'Swelling', 'Urticaria', 'Vision blurred']",2,MODERNA,IM 1049861,CT,66.0,F,"On 2/23/2021 @ 1:00 A.M.;- exactly one week after receiving my first dose of the Moderna CoVid 19 Vaccine on 2/16/21; I developed hives and itching on my left arm at the vaccination site. I awoke @ 10 A.M. on 2/23/2021 with itching , hives, redness and soreness in the same area. As of this writing, circa 3:45 P.M., the redness and itching persists. This is the only adverse reaction I have had thus far from the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/22/2021,6.0,PUB,"Flecainide 50 mg; low-dose aspirin; Vitamin C -500 mg; Zinc -50 mg; Astragulus- 500 mg; Turmeric -500 mg; Magnesium Gycinate -665 mg; Calcium 800 mg; Vitamin A -3,000 mcg; Biotin-10,000 mcg; B6/Folic Acid/ B12 complex;- 1,334 mcg; Melanto",None,Paroxysmal Atrial Fibrillation Seasonal Allergies,,Penicillin * No other KNOWN (!) medication or food allergies.,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site urticaria']",1,MODERNA, 1049862,PA,76.0,F,shingles of face,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,02/02/2021,7.0,PHM,"atenolol, citalopram, atorvastatin, losartan, hydrochlorothiazide, amlodipine, vitamin B12, vitamin D3",none,"hypertension, anxiety, osteoporosis, chronic kidney disease",,no known allergies,['Herpes zoster'],1,MODERNA,IM 1049863,,57.0,F,"Approximately 10 minutes after vaccination (during post vaccination observation), patient reported feeling ?off? and that her throat hurt. I was contacted via radio to aid with assessment. Upon my arrival, patient reported that that she was experiencing slight difficulty swallowing, was feeling ?off? and felt ?like her head was in a fog?. Assessment of vitals revealed an intial vital signs of respiration rate of 18 breaths per minute, pulse of 74 beats per minute, 97% oxygen saturation levels. Blood pressure was obtained prior to arrival and was reported as 121/74. Lungs were clear to auscultation bilaterally. Clear S1 and S2 were present upon cardiac auscultation with no mumurs or gallops noted. Patient appeared slightly pale with a slightly hoarse voice. Patient did not have noticeable pharyngeal edema upon examination. Patiney had no increased work of breathing and was not using accessory Muscles for breathing. Patient was given a swallow test using bottled water and then solid food and demonstrated intact ability to swallow with no regurgitation, choking or drooling noted. Continuous oxygen saturation monitoring revealed 02 that never fell below 96%. Continuous pulse monitoring revealed a pulse that was between 74-79. Given the stability the vital signs, demonstrated ability to swallow and inappropriately labeled IM medication in emergency kit (ie three loose syringes were not drawn up by myself. Medications were labeled by hand with no expiration date, route or dose), I elected to give the patient 25 mg of oral diphenhydramine. Patient declined to seek emergency medical attention several times. Patient?s daughter was then called so that the patient could be driven home. Patient was advised to seek emergency medical attention if her symptoms worsened, she developed increased difficultly breathing or otherwise felt unwell. Advised to follow up with PCP within next 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PUB,,,,,Sulfa (hives),"['Dysphagia', 'Dysphonia', 'Feeling abnormal', 'Oropharyngeal pain', 'Pallor']",2,PFIZER\BIONTECH,IM 1049864,IL,77.0,M,"1/27/21 Emergency room: HPI Patient is a 77 y.o. male who presents after a syncopal episode with cyanosis and shortness of breath. Patient came from rehab where they stated he was sitting on his bed, his oxygen saturation dropped down to 76% on 4L and he became cyanotic. By the time EMS arrived, patient was back to 95% on 4 L. On arrival to the ER, he is 98-100% on 4L. He has a history of COPD and has a chronic cough due to this.Currently, he has no pain, no shortness of breath, no weakness, no cyanosis. He is afebrile and sitting comfortably in bed. 2/10/21 emergency room HPI Patient is a 77 y.o. male who presents with in full cardiac arrest. Patient is resident of local nursing home. According to nursing home staff, a tech was in his room talking with him as patient was laying in bed. Tech began walking out of patient's room and turned around to tell him one last thing when the tech noticed patient had gone unresponsive. Patient had no spontaneous respirations or pulse, subsequently CPR was started immediately. 911 was called. This occurred around 5:30 a.m.. � Upon EMS arrival on scene, they found a male unresponsive with CPR being performed. There was no spontaneous respirations or circulation. Thus, ET tube was placed and life support guidelines initiated. Patient was found to be in PEA, and according to EMS, patient was given a total of 6, 1 mg epinephrine IV push and 1, 1 Amp sodium bicarb. Patient was worked on at the scene for approximately 40 min before being transferred to ER. � Upon arrival to ER trauma room 1 patient is still in full arrest. ET tube in place with good ventilation. Patient remains in PEA. Chest compressions and life support guidelines initiated. � In reviewing patient's chart and nursing home notes, patient is a full code. Patient has a significant cardiac history including known coronary artery disease with 4 vessel CABG. Patient also has history of 3rd degree heart block and pacemaker placement. Patient has history of ischemic cardiomyopathy but last echo performed in 2020 shows ejection fraction of 45%.",Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/27/2021,5.0,SEN,"Current Outpatient Medications: ? albuterol 108 (90 Base) MCG/ACT inhaler, inhale TWO PUFFS every FOUR hours as needed FOR FOR WHEEZING OR shortness OF breath, Disp: , Rfl: ? aspirin 81 MG EC tablet, Take 81 mg by mouth daily, Disp: , R",,,,Sulfa Antibiotics,"['Blood thyroid stimulating hormone', 'Cardiac arrest', 'Chest X-ray', 'Cyanosis', 'Death', 'Differential white blood cell count', 'Dyspnoea', 'Electrocardiogram', 'Endotracheal intubation', 'Full blood count', 'Metabolic function test', 'Oxygen saturation decreased', 'Pulse absent', 'Pulseless electrical activity', 'Resuscitation', 'Syncope', 'Troponin', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 1049865,NJ,44.0,M,"Fever, chills, headache, dizziness, weakness, sweating, shaking.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/05/2021,1.0,UNK,no,no,no,,no,"['Asthenia', 'Chills', 'Dizziness', 'Headache', 'Hyperhidrosis', 'Pyrexia', 'Tremor']",2,MODERNA,IM 1049866,CA,68.0,F,"Woke up Sunday February 14th with flu like symptoms, transient nausea, weak and tired. My left arm was tingling from the elbow down to the side of my hand and my ring and little fingers and palm of my hand were numb. The tingling in my left arm has not stopped since then, my left elbow is sore to the touch and the two fingers tingle and are numb. The flu symptoms subsided by the following day but the numbness and tingling in my left hand has continued.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/14/2021,5.0,PUB,"Amlodipine 5mg, Meloxicam 15 mg as needed for knee pain. Multi vitamin, digestive enzymes, zinc, vitamin D",None,None except worn out knees.,Smallpox. I was about 8 years old,"Soy, Corn, Aspirin, Darvocet, codeine, etc. all prescription pain meds.","['Arthralgia', 'Asthenia', 'Fatigue', 'Hypoaesthesia', 'Influenza like illness', 'Nausea', 'Paraesthesia']",2,MODERNA,IM 1049867,MD,37.0,F,"7 days post vaccine, swelling and a rash appeared at the injection site and through day 8 this was present at the injection site and within a 4 inch radius of the. Site of Injection. Exterior layer of skin was in tact and the swelling , redness and itchiness reduced within 72 hours of onset without taking any medication",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/19/2021,7.0,PHM,Xeljanz XR,None,"Yes, Rheumatiod Arthritis and PCOS.",,Mild allergy to some shellfish and minor seasonal allergies.,"['Injection site pruritus', 'Injection site rash', 'Injection site swelling']",1,MODERNA,IM 1049869,NY,46.0,F,"While Pt was sitting in the waiting area she began to has partial upper body ""seizure"" also breathing problem that included tightness in her throat, husband alerted staff who then alerted EMS, upon arrival to the Pt she was saying under her breath ""EPI"" Pt quickly moved to the back of the tent to the EMS area where EPI .3 administered in the left thigh, lung sounds where having wheezes in both sides. within minutes she stated she felt much better. As we obtained Pt demographic she again stated her throat was feeling tight, second dose of EPI .3 given, within minutes it happened again a total of three EPI .3 given and 50mg of Benadryl given, ambulance arrived to transport.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PUB,Unknown,None,Seizures,,Flu vaccine,"['Condition aggravated', 'Dyspnoea', 'Partial seizures', 'Throat tightness', 'Wheezing']",1,PFIZER\BIONTECH,IM 1049870,IA,49.0,F,I had a sore throat and white patches on tonsils lasting 2-3 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,No,Strep throat,No,,,"['Culture throat', 'Oropharyngeal pain', 'SARS-CoV-2 test', 'Streptococcus test', 'Tonsillitis bacterial']",1,MODERNA,IM 1049871,OR,17.0,F,Reporting a vaccine administration error: unauthorized age group. Vaccinated while not yet 18 years of age. No adverse event.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/23/2021,0.0,PUB,,,,,,"['No adverse event', 'Product administered to patient of inappropriate age']",1,MODERNA,IM 1049872,FL,68.0,F,"I started seeing stars after showering the morning after receiving my shot and eventually blacked out, fell, and struck my head. When I came to, my head was bleeding where it struck the floor and I was in a cold sweat. I crawled to my phone and called 911. They arrived and checked me out, settled me on the couch and gave me tylenol, spoke with a doctor on the phone, and eventually told me that I could get a friend to take me to the ER if I wished. However, my husband is disabled and could not be left alone, so I'd have had to find another friend to stay with him. Although I might have a concussion, my condition seemed OK and I have not had any other severe symptoms so I have not sought further medical attention.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/23/2021,1.0,PVT,"synthroid, amlodipine, telmisartan",none,"high blood pressure, thyroid condition",,sulfa drugs caused headaches,"['Cold sweat', 'Concussion', 'Dizziness', 'Dysstasia', 'Haemorrhage', 'Head injury', 'Loss of consciousness']",2,MODERNA,SYR 1049873,,76.0,M,"Patient had the Moderna vaccine 1st dose roughly 5 days ago. Overnight, his wife woke to him having an episode of what appeared to be a tonic clonic seizure around 5 am on 2/23/21, followed by a period of disorientation and unresponsiveness consistent with a post ictal state. The patient has no history of seizures. It is unclear if this had anything to do with the Moderna vaccine, but I am reporting it due to the timing of the episode in conjunction with the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/23/2021,4.0,PVT,,,,,,"['Disorientation', 'Generalised tonic-clonic seizure', 'Postictal state', 'Unresponsive to stimuli']",UNK,MODERNA, 1049874,GA,70.0,F,"On February 11, 2021, eight days after my shot, my arm became itchy, warm, swollen and red patches. The same arm I received my vaccine in. I took a Benadryl and applied Benadryl cream on the patches. It got better in approximately two days with some residual discoloration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/11/2021,8.0,PUB,Armour Thyroid Inderal Lipitor,None,None,,NKA,"['Peripheral swelling', 'Pruritus', 'Rash', 'Skin discolouration', 'Skin warm']",1,MODERNA,SYR 1049875,LA,73.0,F,Covid arm. Light pink circle around the injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/18/2021,13.0,PUB,Amlodipine 2.5mg Aspirin 81 mg Atorvastatin 10 mg Calcium 600 Vitamin D3 Magnesium 400 mg Zyrtec 10 mg,,,,PCN Doxocyclin Reclast,['Injection site rash'],1,MODERNA,IM 1049876,AL,63.0,M,"Fatigue, headache, muscle pain, and chills",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/21/2021,02/22/2021,1.0,PVT,Escitalopram,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Myalgia']",UNK,MODERNA, 1049877,VA,78.0,F,rash around the injection site. patient has taken benadryl and using topical cream. rash is still present,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/17/2021,7.0,PHM,,,,,,['Injection site rash'],1,MODERNA,IM 1049878,ME,58.0,M,"On the morning of the 17th, a week after the immune reaction from the second shot, started off with a painful rash on the right foot and unable to bear weight. Advised Benadryl and Claritin by physician after sending him a photo. Along with that developed a sore throat and painful swelling at the right base of tongue, almost as if it had been bitten, on and off sweats, temperature on and off to 99 degrees, myalgias and arthralgias. The sore throat got a little better by 2/20, but then started with severe headaches, worse at night, along with intense pain and burning with the neuropathy in my feet flaring up. Dizziness along with the headaches and sharp stabbing pains from the neck on each side up to the back of the years and marked sensitivity of the skull. Almost went to the ER in the middle of the night on 2/21, but increased Tylenol to every 4 hours. the symptoms of the rash and body aches and fever have subsided, but chills come and go. Today, 2/23, the headaches are continuing to get better, but marked sensitivity of skull and head, particularly on the left side, and overall feeling of being tired. I expect over the next few days the headaches will be gone. Didn't expect this delayed reaction after over a week after the second shot, but I guess anything can happen. Have discussed with other coworkers in the medical field that have heard of similar issues, so we are guessing this is a delayed reaction. At least there was no shortness of breath or difficulty breathing.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/17/2021,9.0,WRK,Metoprolol 12.5 mg daily Fosinopril sodium 20 mg daily Aspirin 81 mg daily Vitamin D3 1000 units daily Red Yeast Rice 2400 mg daily Co Q-10 200 mg daily Omega-3 Krill Oil 300 mg daily Asparagus 800 mg daily Magnesium 500 mg daily Levothy,None,"Polycythemia, hypertension, CHF, hypothyroidism, Gilbert's syndrome, Raynaud's syndrome",,Statins,"['Arthralgia', 'Body temperature increased', 'Burning sensation', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Neck pain', 'Neuropathy peripheral', 'Oropharyngeal pain', 'Pain', 'Pain in extremity', 'Rash', 'Sensitive skin', 'Swollen tongue', 'Weight bearing difficulty']",2,MODERNA,IM 1049879,GA,74.0,F,Headache first. Still off and on. Then fever. 101.4 around 5pm same day. 24 hours. Achy neck area. About 10 hrs later Arm redness still ongoing Tuesday 2-23-2021 large area .,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/21/2021,02/21/2021,0.0,UNK,lisinopril hctz. Pravastatin levothyroxine. Florstor probotic,None,Blood pressure. Thyroid. Colorestrol,,Minocin tetracycline medicine,"['Erythema', 'Headache', 'Musculoskeletal discomfort', 'Pyrexia']",2,MODERNA,IM 1049880,AL,85.0,F,"About 12 hours after the receiving the vaccine, I started running a fever. I had mild body aches. That lasted about 36 hours. I had a lost of appetite. The next day (2/18/2021) my arm became swollen and itchy. As of today it slightly swollen, slightly red in color and itching occasionally around the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,PUB,"Fish Oil 100MG daily, Losartan 100 MG daily, Vitamin D3 1000 IU daily, Tum's 1000 MG daily, Baby Aspirin 81 MG daily, Magnesium 250 MG daily, Atenolol 25 MG daily,",,"High blood pressure and thin bones,",,,"['Decreased appetite', 'Erythema', 'Pain', 'Peripheral swelling', 'Pruritus', 'Pyrexia']",2,MODERNA,IM 1049881,IA,45.0,F,"The employee received her second COVID-19 Vaccine at 0744. At 820 she c/o dry mouth and a ""funny feeling in her chest, but not pain."" The employee was brought into the observation room and given 25mg of PO Benadryl. Her VS were 65-18-128/79-98%. Her lung sounds were clear. At 0825 Dr was notified and he came to the clinic. At 0831 the employee states that the chest feeling was improving, her lips and mouth were feeling better. 0910: 57-18-129/75-99% The employee states that she has had an allergic reaction to Versed and Haldol",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/23/2021,02/23/2021,0.0,WRK,,,,,Versed Haldol,"['Chest discomfort', 'Dry mouth']",2,PFIZER\BIONTECH,IM 1049882,NJ,33.0,F,"Rash below injection site. Currently lasting 2+ days. Slight growth in size. Red, warm to touch, itchy, swollen.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/22/2021,2.0,PVT,None,None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site warmth']",2,PFIZER\BIONTECH,IM 1049883,AL,78.0,F,"Patient,had received second dose of Moderna COVID vaccine and was waiting the 15 minutes post injection for observation. Patient reported that she felt her tongue swelling and had difficulty swallowing. Patient anxious, but in no respiratory distress. BP 130/72. Patient was instructed to take some slow deep breaths. Patient continued to c/o tongue feeling thick and she had hacking cough and c/o difficulty swallowing. Patient was given Epinephrine 0.3 auto injector to right thigh at 1:32 pm by RN. BP 150/92, P 90 R 20, Patient also given Diphenhydramine 50mg IM to left deltoid by RN, Supervisor. Patient remained alert and oriented. BP 176/92 at 1:37 pm. EMS arrived on site and monitored patient with EKG, Pulse oximeter, BP and pulse. Patient had some shaking. She remained alert and oriented. Patient refused transport by ambulance to ER. She did agree to go to ER by private car. Patient's husband resent and to transport patient by car to Medical Center. EMS followed patient to hospital. Confirmed that patient was taken to Medical Center ER, by RN.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PUB,Multivitamin Aspirin 81mg Probiotic,none,none,,Allergy to Sulfa,"['Anxiety', 'Cough', 'Dysphagia', 'Electrocardiogram', 'Epinephrine', 'Swollen tongue', 'Tongue disorder', 'Tremor']",2,MODERNA,IM 1049884,CA,53.0,F,"Waited 30 minutes due to history in 2000 of allergic reaction to food. Shot received at 12pm, waited 30 minutes & returned to work. At1:30pm I experienced tingling sensation in lips, slightly numb tongue and had to clear throat, this lasted for about 1 hour. Next day I experienced sore arm & swollen right lymph node for 2 to 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,WRK,None,"Covid 19 mild symptoms (headache, light headedness and light)nausea.",None,,"Tingling in lips, slightly numb tongue and had to clear throat.","['Food allergy', 'Hypersensitivity', 'Hypoaesthesia oral', 'Limb discomfort', 'Paraesthesia oral', 'Peripheral swelling', 'Throat clearing']",1,MODERNA,SYR 1049885,CO,66.0,F,"red patch 2"" x 2"" at edge of injection site; not itching : not raised; a little warm to the touch: no other symptoms, did not seek medical attention",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/22/2021,9.0,PHM,unknown,unknown,unknown,,sulfa drugs,"['Injection site erythema', 'Injection site warmth']",1,MODERNA,IM 1049886,CA,72.0,F,"Patient at Covid vaccine drive up clinic Patient with multiple medication allergies-confirmed with patient Allergies Allergen Reactions ? Levaquin [Levofloxacin] Hives ? Percocet [Oxycodone-Acetaminophen] Nausea and Vomiting ? Amoxicillin Nausea and Vomiting ? Bactrim [Sulfamethoxazole W-Trimethoprim] Other dizziness ? Hydrocodone-Acetaminophen Other ? Keflex [Cephalexin] Other Severe vertigo ? Norco [Apap-Fd&C Yellow #10 Al Lake-Hydrocodone] Nausea and Vomiting ? Oxycodone Nausea and Vomiting ? Tramadol Nausea and Vomiting patient reported tingling of face and lips after receiving vaccine @1630 States lips appeared more swollen then prior to vaccine Denies shortness of breath, wheeze, tongue/ throat swelling, chest pain, palpitation OBJECTIVE: Blood pressure :138/ 78 HR 77 Oxygen saturation 99% on room air Gen: sitting in car. No acute distress Eyes: Conjunctivae and sclera without injection/icterus and lids and lashes normal. Oropharynx moist and intact without lesions. HENT: Atraumatic. No facial droop. Minimal swelling of right upper lip without erythema. Oropharynx moist and intact without lesions. Neck: supple Pulm: No tachypnea, retractions or cyanosis. clear to auscultation bilaterally with symmetric air entry in all fields. Speaking in > 5 word sentences without difficulty. CV: regular rate and rhythm Psych: Speech fluent with normal volume, rate, and pitch alert and oriented x iii,pleasant affect/mood. Skin: Exposed areas warm,dry, without rash or jaundice ASSESSMENT/PLAN: 1. Tingling of face and lips 30 minutes after receiving Covid vaccine. No evidence of hypoxia or respiratory distress/ hemodynamic instability. Patient with history of multiple allergies to medications. Benadryl 25 mg orally x1 given @ 1640 Lot 201666 Exp 04/2023 Reassess in 15-20 minutes Addendum Reassessed at 1700 Patient reports increased swelling/tingling to lips and face right > left Denies shortness of breath, wheeze, difficulty swallowing , itching, hives Exam Gen: sitting in car- appears comfortable Eyes: Conjunctivae and sclera without injection/icterus and lids and lashes normal. HENT: Atraumatic. No facial droop -increased swelling to lips/ perioral right > left -mild erythema periorally -Oropharynx moist and intact without lesions. Neck: supple Pulm: No tachypnea, retractions or cyanosis. Speaking in > 5 word sentences without difficulty Psych: Speech fluent with normal volume, rate, and pitch alert and oriented x iii,pleasant affect/mood. Skin: Exposed areas warm,dry, without rash or jaundice ASSESSMENT/PLAN: 1. Increased edema and patient reports increased tingling of lips/ face ~ 60 minutes after receiving Covid vaccine. Not improved with benadryl 25 mg x1. Concerning for allergic reaction with history of multiple allergies. Urgent Care to continued monitoring and treatment Patient agrees Husband will transport via private care Urgent Care notified by clinic: Patient given EpiPen in case symptoms return. Instructed patient to go directly to the emergency department for any tongue swelling lip swelling trouble breathing or need to use of EpiPen. Patient is asymptomatic. Patient has additional Benadryl or will pick up from the pharmacy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,PVT,,,"Asthma, CKD (chronic kidney disease), stage III, Dysuria, Gastroparesis, Hyperlipidemia, Hypertension, Hypothyroidism, Obesity, OSA (obstructive sleep apnea), Partial anomalous pulmonary venous return (PAPVR) (2012), Polyarthropathy or polyarthritis of multiple sites, Rectal abscess, Rectal cancer (CMS-HCC), Retroperitoneal fibrosis, and Ureteral obstruction",,"Levaquin [levofloxacin], Percocet [oxycodone-acetaminophen], Amoxicillin, Bactrim [sulfamethoxazole w-trimethoprim], Hydrocodone-acetaminophen, Keflex [cephalexin], Norco [apap-fd&c yellow #10 al lake-hydrocodone], Oxycodone, and Tramadol","['Lip swelling', 'Oedema', 'Oral mucosal erythema', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,IM 1049887,FL,60.0,M,"Fever, muscle and joint pain, diarrhea, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/23/2021,1.0,PVT,No,None,No,,No,"['Arthralgia', 'Diarrhoea', 'Headache', 'Myalgia', 'Pyrexia']",1,MODERNA,IM 1049888,NH,66.0,F,"After vaccine she waited and was ok to leave. 11am she begin to feel cold and weak and went to bed, by noon she was so cold and couldn't get warm we put a heat blanket on her and around 2pm she started feeling nauseated and I gave her some nausea meds and Tylenol. It all lasted for 24 hours but the symptoms were identical to the virus she experienced.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,OTH,"Levothyroxine 25mcg, Losartan 50mg, Calafram HBR 10mg,",no,sick with Covid that lasted about 3 months but it was gone by the time of the vaccine,,no,"['Asthenia', 'Feeling cold', 'Nausea']",1,MODERNA,IM 1049889,CA,34.0,F,"About 15 minutes later - body felt like it was on fire; shortness of breath; heart rate was pounding very fast. I stayed in an observation room for about 3 hours. Next day, I couldn't feel my right arm. I started getting fever, chills. I had all symptoms of the coronavirus. Saturday at 03:00 am - I woke up and I couldn't feel my arm or my fingers on my right side. I called the Emergency number. I stayed home and took Tylenol. Couldn't feel my arm at all that Saturday - dead. Sunday - same thing. Monday morning, I woke up, I could feel a little bit of my fingers but I noticed that I had blisters full of blood between your index finger and your thumb. I didn't go to work that day. The doctor wrote me out of work for the rest of the week. I didn't have any sensation on my pinkie or ring finger. I had a little bit of sensation on the rest of my fingers. I stayed at home and I didn't do anything with my arm and it slowly started getting better. That whole week I was having symptoms that were just like coronavirus. They came and went. the following Saturday, I started being able to move my arm around and doing more stuff and slowly it came back but I'm not 100%. I can't lay on the right hand side too long - it starts feeling like my arm is asleep. I got the second dose February 12th. I spoke to an allergy doctor and an anesthesiology doctor (video and telephone visits) - they told me I was having common side affects that people were having from the vaccine but they didn't know why.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,no,no,no,,NSAIDS,"['Blood blister', 'Burning sensation', 'Chills', 'Dyspnoea', 'Hypoaesthesia', 'Palpitations', 'Pyrexia']",1,MODERNA,SYR 1049890,,87.0,M,"Extemely sore left fore-arm muscles for a few hours, followed by fatigue and chills the next morning for about six hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/22/2021,14.0,OTH,"Benazepril, Eliquis",None,Atrial fibrillation,,None,"['Chills', 'Fatigue', 'Myalgia']",1,MODERNA,IM 1049891,TN,88.0,M,"PATIENT RECEIVED FIRST MODERNA COVID VACCINE 1/18/21 AT PREMIER MEDICAL GROUP AND THEN SUBSEQUENTLY VISITED COUNTY HEALTH DEPARTMENT'S COVID VACCINATION SITE ON 1/26/21 AND RECEIVED A PFIZER COVID VACCINE. PATIENT THEN RETURNED TO MCHD ON 2/23/21 AND RECEIVED A SECOND DOSE OF PFIZER COVID VACCINE, RECEIVING A TOTAL OF 3 COVID VACCINATIONS WITHIN 5 WEEKS TIME.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PUB,UNK,UNK,UNK,,PENICILLIN,"['Extra dose administered', 'Inappropriate schedule of product administration']",3,PFIZER\BIONTECH,IM 1049892,CT,69.0,M,"Patient was in to receive his second dose of the COVID vaccine. He reported no known issues after his first dose and remained in the pharmacy for the recommended 15 minute observation period following the vaccine without any problems. He reported to us today that around 45 minutes after having received the vaccine, he started to have a choking episode, something that he commonly experiences with his Parkinson's Disease, so he and his wife didn't think much of it. This seemed to evolve into nausea and dry heaves with excess mucus production that lasted for hours. Because of the duration, they decided to contact his insurance company's nurse line who recommended he go to the Emergency Department to rule out COVID and pneumonia He was admitted to the ED and ultimately found to be negative for both COVID and pneumonia, at which point they decided that his Parkinson's exacerbation might have been the result of having received the vaccine. He has since been discharged and is doing well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,PHM,,,Parkinson's Disease,,Penicillin,"['Choking', 'Condition aggravated', 'Nausea', 'Parkinsonism', 'Retching', 'Rhinorrhoea', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 1049893,CO,65.0,F,"2/18: Slightly sore arm. Awoke with headache. 1 hour later nausea began. Chills, temp which spiked at 102.4 degrees. Extreme fatigue. Slept 12 hours. 2/19: decreased headache, nausea, fever. Fatigue continued X 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,PVT,"Losartan, ASA, multivitamin, cetirizine, simethicone, activated charcoal, Vitamin D3, magnesium glycerinate, calcium chews, polyethelene glycol.",None,"MGUS, AIDP, osteoarthritis, hypertension (controlled on med), GERD with partial Nissen fundoplication, Rt TKA, osteoporosis, rapid gastric emptying",GBS after influenza vaccine in Oct 2015. Sensory symptoms only. Continue to present.,"Lisinopril (cough), Verapamil (rash), Metroprolol (tachycardia)","['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain in extremity', 'Pyrexia']",2,MODERNA,IM 1049894,NE,74.0,F,"Approximately 20+ minutes after the vaccination , little twinges like electric points all over. Very mild and then they went away in about 8 minutes. After that light fatigue and slight headache. When woke up this a.m. just had a sore arm. Everything else is fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PHM,"nothing AT the time of vaccination. 10:30 a.m. took morning dose of Synthroid, biotin, glucosine/condroitin, caltrate,",,,,codeine,"['Fatigue', 'Headache', 'Limb discomfort', 'Sensory disturbance']",1,MODERNA, 1049895,CA,66.0,F,"Very achy joints for 1 day, took tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/19/2021,1.0,PVT,"Levothyroxine, Lisinopril, Bupropion",,"Low thyroid, high BP, depression, hay fever",,Codeine,['Arthralgia'],1,PFIZER\BIONTECH,IM 1049896,WI,16.0,F,Patient did not qualify for vaccine. She is 16 and she is a lifeguard.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PVT,,,,,,['Product administered to patient of inappropriate age'],1,MODERNA,IM 1049897,IN,67.0,F,mild arm soreness at the injection site (none with 1st shot) small unformed/ soft bowel movements for several days at end of second week after 2nd shot (similar but shorter/ day plus symptom after 1st shot),Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/19/2021,11.0,PVT,Paroxetine prn Miralax prn,none,none,,none,"['Faeces soft', 'Injection site pain']",2,PFIZER\BIONTECH,IM 1049898,NC,79.0,F,"allergic skin response with swelling and redness at the injection site and down the upper arm. fever, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,02/20/2021,29.0,PVT,"Albuterol, Hydrocodone, Ambien, Atenolol, Paxil, Metformin","COPD, Diabetes","HTN, obesity",,"Morphine, Levaquin, Valproic acid","['Chills', 'Dermatitis allergic', 'Injection site erythema', 'Injection site swelling', 'Pyrexia']",2,MODERNA,IM 1049899,AR,58.0,M,"Patient was to receive 2nd COVID 19 dose of vaccine today. Facility staff member instructed patient to receive dose after patient had refused initially. Patient verbally agreed. Vaccine was administered. Patient then reported that they had an additional Vaccination Record Card would we like to see it. The patient produced a card that had a dose record given. Upon looking into the records, patient was given a third dose of vaccine today as a result of facility confusion. Patient is doing well, no complaints at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,SEN,Unknown,Unknown,Unknown,,Patient stated no known allergies,"['Extra dose administered', 'No adverse event']",3,MODERNA,IM 1049900,CA,78.0,F,"patient stated she had chest pain while in observation area, patient was alert and oriented, patient stated that she was nervous, emergency services were called and patient was taken to ED",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,PVT,unknown,unknown,"hypertension, anemia, diabetes, ESRD on peritoneal dialysis",,"epinephrine, Iron Dextran","['Chest pain', 'Nervousness']",UNK,PFIZER\BIONTECH,IM 1049901,MN,35.0,F,"patient was receiving 2nd dose of series, during the administration of dose, there was leakage from syringe and needle. Pharmacist proceeded to administer an additional dose without conversion with patient. Concerns regarding potential overdose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/23/2021,0.0,SEN,,,Type 1 insulin dependent Diabetic,,,['Incorrect dose administered'],2,MODERNA,IM 1049902,VA,17.0,F,"Patient is 17yo here for COVID 19 Pfizer Vaccine; Within 15 minutes of the shot, she developed unresponsiveness. She has snoring, seizure disorders, OSA, hypertension, developmental delay, elective mutism. Her mother called us to the room Per mother , She was unresponsive, her lips were blue and she was pale She has had no recent seizure; compliant with Keppra She was very anxious prior to the vaccine. She was at baseline this am per mom prior to the shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/13/2021,02/13/2021,0.0,PVT,,,,,,['Unresponsive to stimuli'],1,PFIZER\BIONTECH,IM 1049903,CA,39.0,M,"Nurse/doctor hit blood vessel during vaccine injection. I bled afterwards but did not feel it. Immediately that evening I began to feel symptoms of fatigue. This grew into an overall feeling of sickness and 3 days later, I had major brain fog. This then developed into high anxiety. However after about day 6 I felt normal again. Then 20 days later, I am feeling the same symptoms again. My armpit is swollen and having brain fog and anxiety.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/19/2021,21.0,PUB,None,None,None,,None,"['Anxiety', 'Fatigue', 'Feeling abnormal', 'Haemorrhage', 'Illness', 'Oedema peripheral']",1,MODERNA, 1049904,IA,76.0,F,"This patient received dose one of Moderna covid19 vaccine on 2/10/21 at 110pm. At 330pm pt c/o sharp abdominal pain, nausea, vomiting, and diarrhea. She developed a rash to left deltoid area on 2/12/21. She continued to have these s/s. She was evaluated at Clinic by Dr on 2/16/21. He increased her Nexium to 40mg twice daily. Upon TC to patient on 2/23/21 she relates still having nausea, diarrhea, and occasional sharp abdominal pains.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/10/2021,0.0,PVT,"prednisone 10 mg one tab po daily, triamterene/hydrochlorothiazide 37.5/25mg one po daily prn severe fluid in legs, esomeprazole 40mg one cap po bid, sertraline 50mg one po daily, levothyroxine 125mcg one po daily, docusate sodium 100mg one",No illness at time of vaccination or one month prior. Of note patient was confirmed to have Covid19 on 12/9/20 by PCR test.,"COPD, nocturnal oxygen use, GERD without esophagitis, osteoporosis, anxiety, depression, hypocholesteremia, osteopenia, vitamin d deficiency, lupus, hyperparathyroidism, osteoarthritis, hypothyroidism, hypercalcemia, sleep related hypoxia, long term (current) use of systemic steroids, nodule right lung, polymyalgia rheumatica, hypertension, BMI 37.1.",,"Thioridazine (reaction: hives, tongue swelling), Prolia (reaction: facial swelling), donepezil (reaction: severe head pain).","['Abdominal pain', 'Diarrhoea', 'Injection site rash', 'Nausea', 'Vomiting']",1,MODERNA,IM 1049905,OH,80.0,F,"Asthma attack began about 20 minutes after injection, with throat tightening, slight mouth swelling sensation and immediate wheezing which grew progressively worse. I had my inhalers (Levalbuterol and Flovent) with me, used Levalbuterol at the direction of medical people who surrounded me after I reported wheezing. They gave me a Benadryl, then brought a wheel chair and sent me directly to the ER. I was there about 3 hours during which I had a heart monitor, a ""breathing treatment"" by a respiratory therapist, and DUONEB, famotidine (PEPCID), and (DELTASONE). I was given a 3 day Rx for 20 mg. of prednisone, and released. My lungs felt ""twitchy"" the next day and my voice was muted, but was well otherwise. The only ""normal"" side effect I had was some soreness at the injection site for a couple of days, with some light sensitivity there for a few weeks.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,PVT,"Monte Lukast, Flonase, Preservision, multi-vitamins, Citra-Cal,, Malic Acid+Magnesium Levabuterol and Flovent as needed",None,"asthma, osteo-arthritis",,"aspirin, NSAIDS, morphine, dilaudid, tapes, cats, dogs, pollens, dust, scents, foods: almond family, squash family, bi-valves","['Asthma', 'Condition aggravated', 'Dysphonia', 'Injection site pain', 'Lung disorder', 'Mouth swelling', 'Photophobia', 'Throat tightness', 'Wheezing']",1,PFIZER\BIONTECH,IM 1049906,DC,71.0,F,The site where I received the shot is still giving me pain when I raise my arm. It has created a weakness or damage to my muscle perhaps.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,OTH,"Rovustatin, Vitamin D,Aleve when needed",None,Plantar Fasciatis,,Tylenol 3,"['Muscle injury', 'Muscular weakness', 'Pain']",UNK,MODERNA, 1049907,VA,17.0,F,"female here with mom mom multiple siblings for Covid vaccine. Within 30 minutes of the Covid vaccine patient had a vomiting episode. Pulse ox was 99. There is no labored respirations. She did not respond to commands but according to his sibling she does not always respond to commands. However when I took her hand to get her to squeeze my hand and gave it back to her she purposefully put it back on a CD which she was holding to her chest. Blood pressure was stable heart rate was approximately 130. The home care aide was not able to tell me whether or not this was her baseline. Her brother said that she does not does not answer questions depending on the day. However I am not sure he is the appropriate historian. She has a history of multiple medical issues including autism, quadriplegia, asthma, and food allergies. As such she was kept here for a full 30 minutes. At no time was there any color change. No labored breathing or wheezing on exam. There is a little bit of nystagmus and appeared to focus when questioned about how she was doing but without a verbal response. She will be transferred to the emergency room in stable condition emergency room has been notified.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/13/2021,02/13/2021,0.0,PVT,,,,,"No known medication allergies, peanut/seafood/seasonal allergies","['Unresponsive to stimuli', 'Vomiting']",1,PFIZER\BIONTECH,IM 1049909,NY,49.0,F,Employee received Moderna vaccine on 1/22/21 at 1:30 pm and later that day at about 5:00 pm she started having severe pain to her left leg and for three days she was dragging her left foot when walking. Today (2/23/2021) employee still have moderate pain to her left leg.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,PVT,no,no,no,,no,"['Gait disturbance', 'Pain in extremity']",1,MODERNA,IM 1049910,CA,61.0,M,"Initially all joints (neck, shoulders, elbows wrists, etc) ached and stiff. Moved to Tendonitis/Arthritis wrists, hands, fingers and Left patellar knee tendon. SLOWLY improved but did not leave, despite treatment with Aleve, until 2nd vaccine 2/5/2021. Then, same symptoms worsened and included BOT patellar tendons, nd plantar tendons. Continues to present and are very painful at night, despite 2 Aleve BID daily, and cannot make fist or extend fingers on both hands and cannot walk on feet without pain at MTP's. Discussed with orthopedic surgeon who assured me that I was having ""an immune reaction in tendons to vaccine. It should get better over time"". It has not at present.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/01/2021,01/07/2021,6.0,PVT,"Albuterol, Aleve, Vitamin D, Antihistamine",none,Exercise induced Asthma,,None,"['Arthralgia', 'Arthritis', 'Gait disturbance', 'Immune-mediated adverse reaction', 'Joint range of motion decreased', 'Joint stiffness', 'Mobility decreased', 'Osteoarthritis', 'Pain', 'Tendonitis']",2,MODERNA,SYR 1049911,IL,60.0,M,"Pt developed R arm rash concerning for herpes simplex vs herpes zoster, culture pending.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/22/2021,25.0,PHM,,None,,,NKDA,['Rash'],1,MODERNA,IM 1049912,WI,76.0,F,"Patient received the Moderna vaccine as second dose in vaccine series, but first dose was utilizing the Pfizer COVID vaccine. No specific adverse events have occurred, but given that a vaccine administration error occurred, I am submitting a VAERS report.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PVT,"Alprazolam, amlodipine, aspirin, atorvastatin, carvedilol, estradiol, losartan, multivitamin, tolterodine",,"Dry eyes, CKD stage III, hypertension",,,"['Interchange of vaccine products', 'No adverse event']",2,MODERNA,IM 1049913,VA,76.0,M,"COVID Arm: Redness, swelling, ichyness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/13/2021,5.0,PUB,None,None,"diabetes, common variable immune deficiency",,None,"['Antibiotic therapy', 'Cellulitis', 'Erythema', 'Peripheral swelling', 'Pruritus']",2,MODERNA,IM 1049914,MT,85.0,M,"Symptoms started approximately 1 week after vaccination, symptoms include fatigue, shortness of breath, water retention, swelling in feet and lower legs, high blood pressure, cough.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/13/2021,8.0,PUB,"Baby aspirin, Spironolactone, Carvedilol, Clopidogrel, Pantoprazole, Tylenol, Super B Complex, Vitamin D3",None,"Pacemaker, artificial hip",,None,"['Cough', 'Dyspnoea', 'Fatigue', 'Fluid retention', 'Hypertension', 'Peripheral swelling']",1,MODERNA,IM 1049916,CA,65.0,F,Mistakenly gave Moderna vaccine for 2nd dose after receiving Pfizer vaccine as 1st dose,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2001,02/23/2001,0.0,PUB,unknown,none known,unknown,,nkdaun,['Wrong product administered'],2,MODERNA,IM 1049917,CA,75.0,F,Sensation of swelling in throat and difficulty swallowing,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,OTH,Clobetasol (OLUX) 0.05 % Top Foam Levothyroxine (LEVOTHROID/SYNTHROID) 88 mcg Oral Tab Fluorouracil (EFUDEX) 5 % Top Crea Albuterol (Ventolin HFA) 90 mcg/actuation Inhl HFAA EPINEPHrine (ADRENACLICK/EPIPEN) 0.3 mg/0.3 mL Inj AutoInj,None,HYPOTHYROIDISM ATHEROSCLEROSIS OF AORTA IGM DEFICIENCY � CORONAVIRUS COVID-19 � HX OF ADENOMATOUS COLONIC POLYPS � HEARING LOSS. � ROSACEA � URINARY INCONTINENCE � ALOPECIA � HX OF INVASIVE BREAST CANCER � SCREENING FOR OSTEOPOROSIS � RENAL CALCULUS � LACTOSE INTOLERANCE � HIGH RISK MEDICATION MONITORING � BILAT DRY EYE SYNDROME � BILAT GLAUCOMA SUSPECT � PREDIABETES � RIGHT MACULAR HOLE � LEFT VITREOMACULAR ADHESION � SPINAL STENOSIS OF CERVICAL SPINE,,HydrocodoneNausea/Vomiting Aspirin Ciprofloxacin Keflex [Cephalexin] Salicylic Acid,"['Dysphagia', 'Pharyngeal swelling']",1,PFIZER\BIONTECH,IM 1049918,MA,43.0,M,"Patient states he had a typical reaction the day of the vaccine (low fever, chills, aches, injection site pain) and when to bed earlier than usual because he was tired. He didn't sleep well, and this morning his sleep app indicated his heart rate during the night was between 100-110. After noticing his heart rate was between 130-140, he called the clinic and was told to go to the ER. Hospital ER administered several tests and did blood work. The MD's determined his heart was fine and it is likely vaccine related. He is home again and is feeling better (no chills, etc.) and his resting heart rate is now in the low-90's.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,PUB,,,Heart issues,,,"['Blood test', 'Chills', 'Fatigue', 'Heart rate increased', 'Injection site pain', 'Insomnia', 'Pain', 'Pyrexia']",2,MODERNA,IM 1049919,NJ,58.0,F,"Just a few hours after the vaccine was administered, my upper arm became swollen. I gradually became more fatigued, lost my appetite for food, and the left armpit lymph nodes began swelling. Then I started having chills and sweats. This lasted for approximately 2 and a half days. On day three, the fever broke, and all adverse side effects slowly began to reverse. On day four, theupper arm and lymph nodes were still slightly swollen, but no longer bothered me.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PUB,Calcium and Vitamin D supplements,none,none,"i also had a reaction to the first Moderna dose: seven days after receiving the vaccination, my left upper arm became red, infl","sulfa, kiwi, almond","['Chills', 'Decreased appetite', 'Fatigue', 'Hyperhidrosis', 'Injection site swelling', 'Lymphadenopathy']",2,MODERNA,IM 1049920,NC,35.0,F,"about a 1.5 weeks after first dose, I noticed my left hand felt swollen but didn't look swollen. I felt joint pain in my body but mostly my finger joints and wrist. Left hand strength had become weak and couldn't put any weight in it or grip. After 12 hrs the swollen feeling went away. The next day I noticed my index finger on left hand was very swollen but my hand didn't feel swollen like the day before. 2 days later I noticed my middle finger on the left hand was swollen. After 12 hours, the swelling is gone. The next week I notice my middle finger on the right hand was swollen. My hands are unable to make a fist when swollen feeling. Now both of my hands are swollen. A hot shower helps and sometime Motrin.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/05/2021,13.0,OTH,none,none,none,,"fresh fruit, bleach to touch, raw potatoes to touch",['Peripheral swelling'],UNK,PFIZER\BIONTECH,SYR 1049921,TX,57.0,F,"on 2/21/2021, I noticed vaccination site was slightly sore again like it had been in days after receiving vaccine and felt a little firm. On 2/22 I felt a slight discomfort and looked at my arm, discovering redness. It looked like a welt approximately 2 inches in height by about 5 inches in length, from the injections site to the inside of my arm. today, on 2/23/2021, I can see that the welt is about 4 inches in height and about 6 inches in width from the inside of my arm to just past the injections site. The welt is not raised, nor does it have any signs of rash. It is just pink. The lower part of my arm below the elbow is 97.2 degrees and the pink area is 97.5 degrees, with an temperature gun.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/21/2021,16.0,OTH,"Metformin, Glimeperide, Omeprazole, Hydroclorithyazide,",none,"Hypertension, Type 2 Diabetes, Obesity",,Naproxin,"['Erythema', 'Injection site induration', 'Injection site pain', 'Urticaria']",1,MODERNA,UN 1049922,IA,36.0,F,"Right arm was red and sore at injection site after dose given. This lasted for a few days just as it happens with other immunizations in the past. The area improved significantly. On day 8 the site got red, warm to touch, shiny, and skin tight, and very sore. It was very itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,01/05/2021,8.0,PUB,"Bupropion; Escitalopram; Vitamin D; Multiple vitamin; Ibuprofen, Acetaminophen",None,None,,Sulfa medications; Shellfish,"['Injection site discolouration', 'Injection site discomfort', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 1049923,GA,47.0,F,"Tachycardia,fever,malaise,fatiuge,headache,congestion, inflamed thyroid",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,12/20/2020,02/03/2021,45.0,WRK,"Allegra,Singulair,Nexium,Lisinopril,Nifedepine,Effexor,Amitriptyline,Exemestane,Restasis,Azelastine",None,"Asthma,Hypertension, Hiatal hernia, Breast cancer (remission) Lymphadema",,"Sulfa,ASA,Aleve,HCTZ","['Blood test', 'Computerised tomogram thorax', 'Echocardiogram', 'Electrocardiogram', 'Fatigue', 'Goitre', 'Headache', 'Laboratory test', 'Malaise', 'Pyrexia', 'Respiratory tract congestion', 'Tachycardia']",2,PFIZER\BIONTECH,SYR 1049924,MI,60.0,F,"presented 1/27 to ED with rigors, dyspnea chest pain and R ear pain post COVID vaccine, thought to initially be systemic SEs from the vaccine but found to have re-collapse of the BI on chest CT with probable post obstructive pneumonia. still admitted as of 2/23/2021",Not Reported,,Not Reported,Yes,27.0,Not Reported,N,01/24/2021,01/27/2021,3.0,PUB,"prograf, prednisone, valcyte, singulair, muran, lexapro,",,"asthma, CAD, COPD, Depression, DVT, GERD, hyperlipidemia, long-term use of drug, lung transplant recipient (June 28, 2020), PVD, scoliosis, spondylosis (cervical), stented coronary artery, tobacco abuse, vocal cord disease",,"reclast, crestor, codeine, norco, oxycodone, tramadol, vicodin","['Aspiration pleural cavity', 'Blood creatinine normal', 'Blood urea increased', 'Bronchoscopy abnormal', 'Carbon dioxide increased', 'Chest X-ray abnormal', 'Chest pain', 'Chills', 'Computerised tomogram normal', 'Dyspnoea', 'Ear pain', 'Full blood count', 'Metabolic function test', 'PCO2 decreased', 'Pleurodesis', 'Pneumonia', 'Troponin increased', 'pH body fluid']",1,PFIZER\BIONTECH,IM 1049925,CO,34.0,M,"headache, fever (presumed), extreme chills, extreme dizziness, extreme body aches. Worst of this was over by mid-day the following day. Chills, dizziness, and body aches continued mildly through Sunday. I also passed out/blacked out the night of getting the vaccine while using the bathroom. Unclear if this was simply due to standing too quickly while experiencing the above mentioned symptoms and blood rushing to my head or a true side effect of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,UNK,,,,,,"['Chills', 'Dizziness', 'Headache', 'Loss of consciousness', 'Pain', 'Pyrexia']",2,MODERNA,IM 1049926,NY,52.0,F,Tachycardia/high blood pressure hours after vaccine admitted to hospital.,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/21/2021,02/21/2021,0.0,PVT,Metapropol,No,High blood pressure Asthma,,None,"['Condition aggravated', 'Hypertension', 'Tachycardia']",UNK,PFIZER\BIONTECH, 1049927,CA,74.0,M,Patient had received first dose of Pfizer vaccine. Received 2nd dose with Moderna vaccine today by mistake.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PUB,,,,,,['Interchange of vaccine products'],2,MODERNA,IM 1049928,AL,63.0,M,It like I was Burn bad on my shoulder . start like a fluid buildup,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/16/2021,6.0,PVT,no,no,no,,no,"['Burning sensation', 'Rash vesicular']",1,MODERNA,SYR 1049929,IL,50.0,F,"The next day after receiving the vaccine, at 9:15 am her hand became numb and she was unable to control or move it. She could not grip the steering wheel or hold anything. She shook her hand and it returned to normal. At 10:15 itjhappened again. It happened a few more time while at work. She also had a few epidsodes in which her jaw became slack and off to the side and she had to close her mouth with her hand, because she could not control her jaw. The episodes lasted about 10 seconds and then they would disappear. She reported her symptoms to the us at about 12:30 PM, 2/23/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PUB,Takes multiple medications,None reported,Pre-diabetic,,No Known Allergies,"['Grip strength decreased', 'Hypoaesthesia', 'Trismus']",1,PFIZER\BIONTECH,IM 1049930,UT,80.0,M,LOST OF TASTE AFTER RECEIVING THE SECOND DOSE,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/23/2021,4.0,OTH,unknown,None,unknown,,unknown,['Ageusia'],2,PFIZER\BIONTECH,IM 1049931,NM,66.0,F,2 days after vaccination right thighs and right leg started to have pain similar to pain I got with polymyalgia rheumatica that I have had in past and I though it was a flare up. A couple of days after that right leg started to swell and was warm. Went to ER on 1/29/2021 and had doppler which showed blood clots from groin area to below the knee. I was placed on Xarelto at that time. Got 2nd dose and about 24 hours latter back of thighs started to hurt again. Called doctor and applied heat and elevation and had no new swelling but I remain on Xeralto. Not sure if it was related but I have had no history of blood clots. 2 years previously broke my right patella and was with brace and no weight bearing for about 8 weeks and brace for 12 weeks without clot issues. Traveled by car a couple thousand miles last year and no issues.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/24/2021,2.0,PVT,"atorvastatin, CoQ10,multivitamin, vitamin D3,prilosec",? slight discomfort in back of thighs ? polymyalgia flare up,"diabetes, polymyalgia rheumatic",,"Aleve, avocados","['Full blood count', 'Metabolic function test', 'Pain in extremity', 'Peripheral swelling', 'Skin warm', 'Thrombosis', 'Ultrasound Doppler']",1,PFIZER\BIONTECH,IM 1049932,PA,77.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/01/2021,02/20/2021,19.0,SEN,Anoro metformin glipside ozempic flauticasone ramipril atorvastatin Effecsor doneprazol pabtoorazoke Trulance Fish oil calcium vit d vi t b complex Co q 10,Stomach virus,Diabetes high BP hi cholesterol ibs lactose intolerant copd,,Prednizone,['Unevaluable event'],UNK,PFIZER\BIONTECH, 1049933,NC,81.0,F,"Shingles rash, right ear and neck",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/20/2021,6.0,PVT,"famotidine, LASIX, amiodarone, Tylenol, Lipitor, Eliquis, hydralazine, Toprol-XL, nifedipine, Prilosec, Coreg, timolol ophthalmic, omega-3 fatty acid",None,"a-fib, hypertension, GERD, hyperlipidemia, osteoarthritis",,"ibandronic acid, aspirin, penicillin, sulfa, doxycycline",['Herpes zoster'],2,PFIZER\BIONTECH,IM 1049934,OH,78.0,F,Developed urticaria within 2 hours of vaccine. Rash began on chest and spread to her neck and on her face.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,"Lipitor, Vitamin D, Norco, Vitamin C, Paxil, Xalatan, Imitrex, Restasis",Left thumb carpometacarpal arthroplasty on 2/18/21,Migraines Diverticulosis Vasovagal syncope Dry eye syndrome Former smoker Trigeminal neuralgia Rosacea Post-menopausal Allergic rhinitis Sleep apnea Resolved osa per pt after cervical fusion colonic polyps,,Bactrim and Orphenadrine,"['Rash', 'Urticaria']",1,PFIZER\BIONTECH,IM 1049935,NY,59.0,F,"1/4 left shoulder pain, rigors, joints pain and pain between shoulder blades, fever 100.8, fatigue, took tylenol100mg and Advil 400mg 1/5 shoulder pain subsided a little",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,PVT,,,,,,"['Arthralgia', 'Back pain', 'Chills', 'Fatigue', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1049936,IL,80.0,F,"""within 24 hours after the vaccine, my heart started racing and my blood pressure went up""",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/27/2021,1.0,PVT,aspirin carvedilol dicyclomine ezetimibe hydrocodone linagliptin losartan lutein nitroglycerin pantoprazole pioglitazone pramoxine-CH,,,,Levothyroxine flagyl Shellfish Cipro Iodinated diagnostic agents Iodine Iron Sulfa antibiotics Tetracycline Zocor,"['Blood pressure increased', 'Palpitations']",1,MODERNA,IM 1049937,NY,26.0,F,Pt came in to have 2nd vaccine pt started to notice her arm itching and saw hives PT alerted us and was taken in medical evaluation room where she was given 50 mg of benadryl Pts hives went away with no other reaction Pt left via POV,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PUB,,,,,,"['Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,IM 1049939,CA,68.0,F,"First, the shot hurt when I got the injection. Most people say they don't even feel it, but I definitely felt the needle go in and then felt the fluid go in. By late afternoon, my left arm was very sore . By evening, I couldn't lift my arm at all due to pain in that muscle at the top of my shoulder. I think by that night but perhaps by the next morning I still couldn't lift my arm and the pain had gone into my neck on the left side. After about 36 hrs, it started getting better but it was extremely sore for at least 4 days. I still have some residual pain in my left arm and the base of my neck on that side. About 4 days ago, I noticed a round bruise about the size of a quarter about 1.5 inches away from where I think the shot was administered. I am not aware of anything that might have caused it, but Im pretty sure it wasn't where the shot was administered. It seems to be growing a bit from when I first noticed it.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/11/2021,02/11/2021,0.0,WRK,"Rizotriptan (for a migraine the night before and then again after the shot when the headache got worse)-- Herbals--""Migravent"" and feverfew for migraine prevention taken daily ""Ecodrink"", a daily vitamin supplement","I had a migraine the night before the injection, and took a dose of rizotriptan the day before and another later in the day after the shot when my headache did not go away",migraines orthopedic issues with knees and feet,,none,"['Injected limb mobility decreased', 'Injection site bruising', 'Neck pain', 'Pain in extremity']",1,MODERNA,IM 1049940,IL,22.0,F,"Vaccine administered past 6hr post puncture of vial. No adverse reaction occurred. Per Moderna, no actions required at this time, proceed with 2nd dosing as scheduled.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/17/2021,0.0,OTH,,,,,,['Product storage error'],1,MODERNA,IM 1049941,NY,67.0,F,"Note: this was a POSITIVE effect worthy of study! I was resigned to being a long hauler after 8 werks of 100 degree fever and fatigue, but on 3rd day after first Pfizer vaccine, I woke up totally symptoms free. Did the vaccine give me something my body couldn?t produce, or just push my immune system to kick out a new round of fresh antibodies? This could be extra good news for longhaulers. Should be studied.....",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/19/2021,3.0,OTH,Levothyroxin Hormone replacement Multivitamin 5000 vit D 50 Zinc,Lingering fever ~100 after covid virus since Christmas day,As above Chemo 5 yrs ago due to lymphoma,,No,"['Fatigue', 'Pyrexia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1049942,TX,40.0,F,Excess gas after 2 hours of injection and nausea. 20 hours - lower abdominal pain with feeling of having to use the bathroom,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,PVT,None for 24 hours,,,,Allergic to hay,"['Abdominal pain lower', 'Flatulence', 'Gastrointestinal motility disorder', 'Nausea']",2,PFIZER\BIONTECH,SYR 1049943,MI,55.0,F,"Persistent, intense pain at injection site and up into shoulder and neck",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,SCH,None,No illnesses,"Allergies, asthma, PCOS, arthritis, degenerative disc disease",,"Many, many environmental allergies, no foods, Oxycodone","['Arthralgia', 'Injection site pain', 'Neck pain']",2,MODERNA,IM 1049944,CA,52.0,F,"Patient arrived and stated she had an appointment for COVID-19 vaccine #2. After the vaccine was administered, the vaccine card to stamp the date/lot number on it. It was then realized the Pfizer was given to the patient instead of Moderna (which was her first dose on 1/15/2021. She then had a consult with a Physician, waited 15 minutes, and then went home for the day without incident. Follow-up call make to patient on 2/18 to review stability post vaccine, which she confirmed to be feeling well on this date. Internal processes for member check-in and vaccine history reviewed, revised as result of the above. All patients presenting for vaccine will have their vaccine card reviewed prior to 2nd vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/12/2021,0.0,PVT,unknown,unknown,,,unknown,['Wrong product administered'],2,PFIZER\BIONTECH,IM 1049945,OR,64.0,F,"10 mins after 2nd dose, pt started having upper back itchy feeling. Came to nurse observation area. no rash observed. BP elevated.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PUB,unknown,unknown,unknown aside from High BP,,"Sulfa, various food allergies like soy","['Blood pressure increased', 'Pruritus']",2,PFIZER\BIONTECH,IM 1049946,AZ,43.0,F,"Starting February 18 - today (Feb 23) soreness under left arm --most painful 19-21 Feb 20-22 -developed large 3-4 inch pink circle over injection site, itchy at some times but not often -under left eye became red/pinkish then became slightly swollen, almost similar to a stye. Both are clearing and are almost gone but not 100% took benadryl and tylenol 1-3 times a day throughout feb 20-22",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/18/2021,6.0,OTH,"folic acid, vitamin D, xyzal, levothyroxine",UTI - 4 weeks before,"hashimoto's disease, macrocytes",,,"['Axillary pain', 'Erythema of eyelid', 'Hordeolum', 'Injection site erythema', 'Injection site pruritus', 'Swelling of eyelid']",1,MODERNA,IM 1049947,IL,38.0,M,"Vaccine administered past 6hr post puncture of vial. No adverse reaction occurred. Per Moderna, no actions required at this time, proceed with 2nd dosing as scheduled.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/17/2021,0.0,OTH,,,,,,"['No adverse event', 'Product storage error']",1,MODERNA,IM 1049948,FL,66.0,F,"Low grade fever, lethargy, sore arm",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/07/2021,1.0,UNK,None,None,None,,None,"['Lethargy', 'Pain in extremity', 'Pyrexia']",2,MODERNA,SYR 1049950,UT,73.0,F,"Friday, 2/19/21 Received 2nd Modurna shot at 1:50 PM. No adverse symptoms Saturday, 2/20/21 Woke up with inflamed left art, area around shot bright red and swollen and approximately 2"" X 3"". Extreme pain in joints, hips and back lasting the entire day. Entire body uncontrollable shaking, lasting approximately 1 hour, over entire body. Started at 10:00 AM. Took ibuprofen every two hours the entire day, starting at 9 AM Sunday, 2/21/21 Woke up with redness and swelling in left arm much larger than previous day, approximately 3"" by 4"". Other symptoms much reduced Monday, 2/22/21 Woke up with swelling and redness increased to 4"" X 5"". Took Benadryl at 10PM for swelling Tuesday 2/23/21 Woke up with swelling and redness almost completely gone",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,OTH,None,Fibromyalgia and chronic fatigue,Fibromyalgia and chronic fatigue,,"Codine, tetanus","['Arthralgia', 'Back pain', 'Injection site erythema', 'Injection site swelling', 'Tremor']",2,MODERNA,SYR 1049951,AK,82.0,F,"Long term well controlled Type 1 diabetic, on insulin pump -- on day following vaccination blood sugar spiked to 399, remained elevated for 48 hours, then normal since.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,PUB,"Humalog,Eliquis, Toprol XL, Xanax, folic acid, Avapro, Zocor,",None,"Type 1 diabetes since age 12, atrial fibrillation, mild heart attack in 2002.",,"Morphine, codeine",['Blood glucose increased'],2,PFIZER\BIONTECH,IM 1049952,NC,86.0,F,"On 2/14 the patient describes the typical symptoms of a sore arm at the injection site. The patient reports an expected decrease in symptoms until 2/22/21, when the injection site became itchy and swollen, and developed a slight rash. I advised the patient to take Tylenol for pain/fever (especially for her second dose on 2/24/21), to take Benadryl at nighttime for the rash, and to use some OTC topical lidocaine for the itching/discomfort as needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/14/2021,1.0,PHM,,,,,,"['Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling']",1,MODERNA,IM 1049953,NY,44.0,F,5:30pm 2/22/21 started feeling ache ate dinner: 7:30pm started vomiting with fever of 100: 9pm sever chills with sweats: 9:30pm vomited layed down: 1am woke sweating shivering fever still 100 took a shover started extreme body aches with chest pain: drove myself to Stony Brook ED: labs ran covid swabbed still with all symptoms: chest xray preformed: released at 6am was told to monitor symptoms and if I can not keep anything down like water and or still with chest pain after 24hrs return to ED,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,OTH,"paroxetine 20mg, atenol/chlor50-25mg, lisinopril 10mg",none,hypertension,,none,"['Blood potassium decreased', 'Chest X-ray normal', 'Chest pain', 'Chills', 'Hyperhidrosis', 'Laboratory test normal', 'Pain', 'Pyrexia', 'SARS-CoV-2 test', 'Vomiting']",UNK,PFIZER\BIONTECH,SC 1049954,WA,70.0,F,Developed urticaria 1 week following vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/10/2021,0.0,PVT,"Celexa, Famotidine",Anxiety,Anxiety,,"Kelp, Iodine",['Urticaria'],UNK,PFIZER\BIONTECH,IM 1049955,IL,28.0,F,"Vaccine administered past 6hr post puncture of vial. No adverse reaction occurred. Per Moderna, no actions required at this time, proceed with 2nd dosing as scheduled.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/17/2021,0.0,OTH,,,,,,['Expired product administered'],1,MODERNA,IM 1049956,CA,80.0,F,"Slight headache, chills, loss of appetite. Gone in 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/14/2021,02/16/2021,2.0,OTH,,,diabetes,,,"['Chills', 'Decreased appetite', 'Headache']",UNK,PFIZER\BIONTECH, 1049957,CA,22.0,F,Facial rash/pruritus,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PVT,"Ibuprofen, cyclobenazaprine",,,,no known,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH,IM 1049958,FL,68.0,F,Arm soreness and hot since injection. On day 5 swollen rash developed with itching.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/23/2021,5.0,PUB,,,,,,"['Pain in extremity', 'Rash pruritic', 'Skin warm', 'Swelling']",UNK,MODERNA,IM 1049959,KS,36.0,M,"Patient started experiencing lymphodema under left arm. Arm is painful to touch. Slightly red. Encouraged warm compress, Tylenol alternating with ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/20/2021,2.0,PUB,None,None,RA,,None,"['Erythema', 'Lymphadenopathy', 'Pain in extremity']",2,MODERNA,IM 1049960,WY,66.0,F,"2/17/21-Anaphylaxis-15:17pm (within 30 min waiting period post vaccine), throat scratchy, moved to assessment area, HR 100, labored resp, O2 6L NRmask initiated. (ct reports similar reaction as previous anaphylaxis). 15:22pm-911 called, HR 120, Epi 0.5ml admin. 15:37pm transfer via ambulance to hospital. 02/18/2021 evening, f/u call to client by PHN, throat still feels 'weird', ct reports had 2nd Epi in ambulance, 3rd Epi in ER, plus Benedryl gel, Ct then recalled had anaphylaxis reaction in past to bee sting had ER visit, tx w/ steroids at that time. PHN recommended ct talk with PCP re epi pen order.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PUB,,,,,"sulfa meds, Bee Stings(anaphylaxis)","['Anaphylactic reaction', 'Throat irritation']",1,PFIZER\BIONTECH,IM 1049961,CA,66.0,F,Blotchy Rash covering the upper arm about 6 inches in length and about 5 inches wide. It is a little bit warm to the touch. very mild itching from time to time. It may have appeared before this report but I was wearing long sleeves until the weather got warmer yesterday so never notices it.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/21/2021,13.0,PVT,"Synthroid, Daily vitamin, Calcium w/D, Vitamin B-12, Vitamin D, Magnesium Citrate, Co-Q10",none,none,,codeine,"['Pruritus', 'Rash macular', 'Skin warm']",1,MODERNA,IM 1049962,CA,74.0,F,"Felt ugh, fuzzy headed next day, got chills and had mild fever (99.2), took 2 Tylenol, sucked in couple ColdEeze and felt better within few hours. Red area on sot arm by that evening - next day (2nd day after shot) developed red rashes by outside of each breast, larger spot by left side (where shot was given), spot on left side of my neck also. Not a raised or bumpy rash at all, not sore or itchy. Called advise nurse to determine taking a benedryl was ok and took one last night. This morning rash less noticeable but still there - also new little mark on inner left elbow. Feeling fine this whole time, just concerned because I haven?t read of this reaction much for second Moderna.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/21/2021,1.0,SCH,Levothyroxine Lexpapro 10 mg 4 days a week baby aspirin,Had a small squamous cell removed from left leg between vaccines,None,,No,"['Chills', 'Erythema', 'Feeling abnormal', 'Pyrexia']",2,MODERNA,SYR 1049963,CA,56.0,M,"Found lying face down without respiration or pulse, believed to be within 5 minutes of event. ACLS procedures unsuccessful. Unable to get autopsy. Believed to be heart attack secondary to COVID infection, but unconfirmed. Relative contribution of recent vaccination unknown.",Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/22/2021,10.0,PVT,"chlorpromazine 800mg QHS amantadine 100mg BID divalproex 1000mg QAM, 1500mg QHS haloperidol decanoate 225mg Q2weeks amlodipine 5mg QHS carvediol6.25mg BID docusate sodium 250mg BID fluticasone propionate 1 spray each nostril BID lisinopril",,"obese, pre-diabetic, hypertension, atherosclerotic disease, coronary artery blockage, schizoaffective disorder Tested COVID-19 positive on 1/21/2021, asymptomatic, 1-1/2 weeks after first COVID-19 vaccination",,NKA,"['COVID-19', 'Myocardial infarction', 'Pulse absent', 'Respiratory arrest', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1049964,IA,97.0,M,"Patient's daughter reported that the day after vaccination, patient had facial droop, some slurred speech, and her legs hurt/were week. This resolved on it's own, and it does not sound like they sought treatment for this.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/06/2021,02/07/2021,1.0,PVT,,,,,,"['Dysarthria', 'Facial paralysis', 'Muscular weakness', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 1049965,,,U,"RN within our mass vaccination center drew Moderna vaccine from vial prior to the 15 minute room temperature recommendation. The vial, Lot# 043L20A, was pulled from the refrigerator at 1:34pm CST. The dose was drawn at approximately 1:45pm CST and was subsequently administered at approximately 1:47pm or 1:48pm CST. This would have resulted in administration 2-3 minutes in advance of the 15 minute recommended wait time. The timing error was discovered by this RN and another RN within the vaccination team approximately 2-3 minutes after the vaccination was administered. We were unable to identify, with certainty, the patient within the mass vaccination center who received the dose. We had no adverse reactions reported in the patient monitoring/observation area during the 15 minutes subsequent to our discovery of the early administration. Our physician lead in the patient monitoring/observation was notified of the error.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/23/2021,,,OTH,,,,,,['Product storage error'],UNK,MODERNA,IM 1049966,IL,60.0,M,"-Sore muscle around injection site lasting for about 24hours -approximately 24 hours after injection I had muscle, joint and skin aching all over my body that lasted about 7 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2012,01/28/2021,3289.0,PHM,,none,peripheral neuropathy,,None,"['Arthralgia', 'Injection site pain', 'Pain of skin']",1,PFIZER\BIONTECH,IM 1049967,MA,66.0,F,"Caller stated that she received her vaccine on 02/23/21 and an hour later her face became numb and became lightheaded. She went home and took 2 benadryl liquigels and her light headedness went away, but was still feeling the numbness in her face. She denies fever, aches or chills. Patient advised to monitor and calll PCP if symptoms don't get better or call for help if experiencing SOB.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/23/2021,02/20/2021,,UNK,,,,,,"['Dizziness', 'Hypoaesthesia']",UNK,MODERNA, 1049968,MS,63.0,F,"Client received dose of vaccine at approx 1225. Was sitting in parking lot for monitoring. Summoned attendance d/t report of heart racing, slight SOB, ""weird feeling in chest"". RN and NP were called. By their arrival, pt reported s/sx beginning to resolve. At 1240 BP 100/78, HR 72. At 1250: BP 100/78, HR 80. At 1300: BP 108/70, HR 72, R 18. Pt was instructed to go home and rest. Was allowed to leave site. RN called pt at 1435. Pt reported all symptoms had resolved. Was doing fine. RN",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,OTH,"synthroid, ArmourThyroid, Wellbutrin, Prozac, Estradiol Patch, pregesterone, omeprazole, myrbetriq, zyrtec, trazodone, adrevine, probiotic, B-12 Vitamin C, melatonin, magnesium, Vitamind D-3, Calcium, L-Theanine, B-2.",,"hypothyroid. States levels were ""out of whack"" about a week ago and synthroid dose was increased recently.",,unknown antibiotic,"['Chest discomfort', 'Dyspnoea', 'Palpitations']",2,PFIZER\BIONTECH,IM 1049969,TN,71.0,M,Approximately 1 week after the Pfizer dose I had a small lump and soreness over my right flank at the kidney level. Over the next two days that pain migrated to my right buttock and radiated down my right leg. With full weight applied to my right leg the leg had weakness and would occasionally buckle. I am due for my second injection but am considering not taking the second injection fearing permanent nerve involvement. As of today 2/23 the pain in my right leg and buttocks is lessened but still present.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/19/2021,9.0,PVT,Eli quiz 2.5 bid,None,None,,None,"['Flank pain', 'Joint instability', 'Mass', 'Muscular weakness', 'Musculoskeletal pain', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 1049970,TN,59.0,F,"Moderna COVID-19 Vaccine EUA Had the normal side effects on 2-20-21, chills, fever, body aches, but on 2-21-21 I woke up with a rash all over torso and arms, sneezing, scratchiness in throat and a spot under the vaccine that is a knot and red, very itchy. Today, the 23, there is still some sign of the rash and the place on my arm is still there.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/23/2021,4.0,PUB,"Progesterone, Estradiol, Lisinopril, Synthroid, Montelukast Sodium, Valacyclovir HCL, Wixela, multi vitamin, aspirin 81, magnesium, Vitamin B",,"High BP, thyroid, asthma",,Floxin,"['Chills', 'Injection site erythema', 'Injection site mass', 'Injection site pruritus', 'Pain', 'Pyrexia', 'Rash', 'Sneezing', 'Throat irritation']",1,MODERNA,IM 1049971,CA,64.0,F,Onset of Bell's Palsy about 5 days after immunization.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/25/2021,5.0,PVT,"Chlorthalidone, Losartan, Oyster shell calcium, vitamin d,",none,"hypertension, obesity, prediabetes, anxiety",,ace inhibitors,"[""Bell's palsy"", 'Visual acuity tests']",1,MODERNA,SYR 1049972,HI,43.0,F,"Patient presents for evaluation of encounter for immunization. Here for moderna COVID-19 vaccine #1. See scanned vaccination screening form and post vaccine questionnaire.@1713 Patient reports that her lungs ""felt tight"". She denies mouth swelling, facial swelling, tongue swelling, throat tightness, difficulty breathing or speaking. Denies GI distress, nausea. Denies rashes, itching or other symptoms. She denies allergies. Denies chronic conditions. Denies daily medications. She reports her only medical history is ""childhood asthma"" and does not take any medication currently. (1715) Patient escorted to exam room for privacy and monitoring. Patient able to ambulate without difficulty or distress. She reports her ""chest tightness"" is a 6 (0-10 scale). And denies other symptoms including chest pain, itching, mouth swelling, SOB. Patient reports she prefers to sit in chair, vs lying on exam table, VS monitored by RN. ROS: CONSTITUTIONAL: Negative for chills, fatigue, fever, and weight change. EYES: Negative for blurred vision, eye pain, and photophobia. E/N/T: Positive for Denies mouth, tongue swelling. Denies throat tightness.. CARDIOVASCULAR: Negative for chest pain, palpitations, tachycardia, orthopnea, and edema. RESPIRATORY: Positive for Denies cough, distress, endorses ""tight chest"". GASTROINTESTINAL: Positive for Denies nausea, vomiting, GI distress, diarrhea. INTEGUMENTARY/BREAST: Positive for Denies rashes, lesions, changes to skin.. Vitals: Current: 2/19/2021 4:48:38 PM T: 97.9 F (temporal); BP: 174/104 mm Hg (right arm, sitting); P: 81 bpm (finger clip, sitting)O2 Sat: 100 % (room air) Repeat: 5:38:26 PM BP: 182/108mm Hg (left arm, sitting, 5:17pm) 5:38:59 PM BP: 158/97mm Hg (right arm, sitting, 5:26PM) 5:40:22 PM O2 Sat: 100% (room air, 5:26PM) 5:39:56 PM P: 73bpm (finger clip, sitting, 5:26PM) Exams: Initial Exam completed by NP at 1713, 1720, 1730, 1740 and 1746. No changes from baseline GENERAL: well developed, well nourished, in no apparent distress;; well developed; well nourished; well groomed; no apparent distress EYES: lids and conjunctiva are normal; pupils and irises are normal; E/N/T: normal external ears and nose;; Hearing: grossly normal Lips, Teeth and Gums: normal; Oropharynx: normal mucosa; NECK: Neck is supple with full range of motion; RESPIRATORY: normal respiratory rate and pattern with no distress; even and unlabored, no wheezing; CARDIOVASCULAR: normal PMI placement; no thrills, heaves, or lifts; normal rate and rhythm without murmurs; normal S1 and S2 heart sounds with no S3, S4, rubs, or clicks;; normal rate; regular rhythm; irregular rhythm; Radial pulses +2 CR< 3 seconds BUE; GASTROINTESTINAL: no masses or tenderness; SKIN: no ulcerations, lesions or rashes no skin thickening, induration, or subcutaneous nodules; NEUROLOGIC: AOx3, awake, alert, calm PSYCHIATRIC: mental status: alert and oriented x 3; appropriate affect and demeanor; recent and remote memory are intact; good insight and judgement; Procedures: Encounter for immunizationBenadryl 50 mg tab given PO per, NP at 5:14pm 1. Epinephrine given IM, in the right thigh; administered by: employee; ( lot #0GM147; exp. 11/2021 ) 5:37pmVS were monitored closely by RN and NP during reaction, see chart for RN's VS **Requested RN to chart her VS: see ""Post COVID-19 Vaccination Questionnare for VS completed by employees 1714 Benadryl given PO 1726: VS: Ox 100% on RA RR 16 HR 73 BP 158/97 1731 VS: Ox 98% RA RR 16 HR 84 - patient reports chest tightness is worsening: Ordered IM epi, given by RN 1738 VS:Ox 99% RA RR 16 HR 83 BP 167/114 1742 VS: Ox 100% RA RR 16 HR 89 1746 VS: Ox 100% RA RR 16 HR 80 167/98 Plan: Encounter for immunizationvaccine given per protocol.30 minutes after vaccine, patient c/o chest tightness. PO benadryl and IM epi given per protocol, VS monitored per protocol and documented by RN and NP 1) Protocol followed for anaphylaxis 2) Patient remained stable under care. Patient AOx3, awake, no respiratory distress, talking and smiling. 3) (1537) Informed patient we are calling 911 due to administration of Epi and patient's reported symptoms. Patient refused. Re-educated to the importance of calling 911. Patient refused x 3. 4) Husband presented to drive patient to the emergency room. Re-educated to the importance of calling 911 for anaphylaxis. Patient and husband refused. Husband committed to taking patient straight to Emergency Room, and to call 911 on the way if she gets worse in any way. Patient and husband both agreed to this. 5) Educated patient that she must seem emergent medical attention for anaphylaxis. Educated patient to NOT get second vaccine. 6) (1746) Patient reports her chest tightness has gone from a 6 to a 2 (0-10 scale) 7) Patient and husband v/o and agrees to POC. 8) (1746) Patient left in stable condition, under the care and supervision of husband with plan to go straight to the Emergency Room and to call 911 immediately if anything changes or worsens. 9) Case and chart reported to Medical Director.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,PVT,No meds,,,,NKDA prior to vaccine,"['Blood pressure increased', 'Chest discomfort']",1,MODERNA,IM 1049974,,54.0,F,Bilateral subcutaneous swelling in each arm that has persisted for 1 month following vaccine (had doses in separate arms and nodules developed after each vaccine),Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,02/05/2021,5.0,PVT,Advair,,ASthma,,,"['Nodule', 'Peripheral swelling']",UNK,PFIZER\BIONTECH, 1049975,VA,86.0,F,Pt. c/o of cramping all over & shortness of breath.,Not Reported,,Yes,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PUB,,,,,,"['Dyspnoea', 'Muscle spasms']",2,PFIZER\BIONTECH,IM 1049976,MA,76.0,F,"Caller stated that she received her vaccine on 02/20/21 and the next day the injection site became red and oval in shape measuring 1x4 inches, not sore or discomfort of any nature. Then today 02/23/2021 the redness extended to the rest of the arm and still no discofort of any nature. Patient asked to follow up with her PCP for further evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/21/2021,1.0,UNK,,,,,,"['Erythema', 'Injection site erythema', 'Injection site swelling']",UNK,MODERNA, 1049977,NY,87.0,M,"Rash at the site of the vaccine, about 2 inches in diameter, appeared 10 days after vaccine administered,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/23/2021,10.0,SCH,"Norvasc, Eliquis, Atenolol, Lexapro, Zetia, Protonix, Crestor, Glucosamine, Centrum MultiVitamin, Vitamin C, Vitamin D, B-complex vitamins",,High blood pressure,,Sulphur,['Injection site rash'],UNK,MODERNA, 1049978,PA,53.0,F,"Covid arm. Swelling, redness, warmth at the site of the injection. Started 5 days after injection and lasted 7 days. Treated with antihistamine and warm compress.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/14/2021,5.0,PUB,None,None,Asthma Autoimmune disorder,,"NSAID's, Penicillin, Bactrum, Sulfas Asparagus Seasonal","['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 1049979,,67.0,F,Blood pressure jumped high. Heart rates speedy over 100 beats/min. Dizzy all the time. Constantly coughing.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/05/2021,02/07/2021,2.0,UNK,,,,,,"['Blood pressure increased', 'Cough', 'Dizziness', 'Heart rate increased']",UNK,MODERNA, 1049980,HI,24.0,F,"Patient had arm soreness x 2 days after injection, then resolution of symptom. On 2/19/21, patient developed annular, erythematous rash at injection site. TX: Benadryl and observation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/19/2021,7.0,PVT,,,,,,"['Injection site erythema', 'Injection site rash', 'Pain in extremity']",1,MODERNA,IM 1049981,WV,81.0,M,Itchy rash all over the body. Red pimples and streaks of red welts.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/08/2021,2.0,OTH,"Brewers Yeast, PreserVision AREDS2, Raw Zinc 30mg, Raw D 5,000IU, Saw Palmetto",Bakers cyst in right leg behind knee.,,,None,"['Acne', 'Rash', 'Rash pruritic', 'Skin discolouration', 'Urticaria']",UNK,PFIZER\BIONTECH,IM 1049982,MN,52.0,F,"Fever, sweating, lightheadedness, fatigue, severe body aches, chills, sore throat, stabbing pain in various areas of my body. Shortness of breath. Pain with swallowing . All of these things still present.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,OTH,None,None,Non,,"Hydrocodone, morphine","['Chills', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Hyperhidrosis', 'Odynophagia', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",2,MODERNA,IM 1049984,,43.0,F,"Hive at injection site 2 weeks after vaccine. Soreness, itching, swelling at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/10/2021,02/23/2021,13.0,UNK,,,,,,"['Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Injection site urticaria']",UNK,MODERNA, 1049985,WI,43.0,F,"Within minutes of receiving the first dose of the vaccine, my tongue became itchy. As the evening went on, my neck became sore. I took an antihistamine that evening when I got home. The itchy tongue continued for approx 10 days, following the injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,PVT,"I take vitamin supplements, Natural Factors Vitamin D3, 5K units daily, Gaia Herbs Elderberry , 50mg, 1 capsule daily, MegaFood Ultra C-400, 400mg, daily, and Florajen daily",None,Asthma and chronic bronchitis,,allergic to penicillin,"['Allergy test negative', 'Neck pain', 'Tongue pruritus']",1,PFIZER\BIONTECH,IM 1049986,PA,66.0,F,"Patient reported that approximately 3-4 days after receiving vaccine, she developed itching and redness around the shot area, with symptoms worsening each day. Reported that she self-treated with steroid cream (name not given), anti-itch cream, and diphenhydramine oral at bedtime. Symptoms lasted approx 10 days and were completely subsided when presented today for Dose 2.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/29/2021,3.0,PHM,,,,,latex,"['Injection site erythema', 'Injection site pruritus']",1,MODERNA,IM 1049987,OK,65.0,F,"got vac at 12:30 pm 2/20/21, started feeling flue like approx 5:00 pm 2/20/21,sore arm running up my neck and shoulders, body aches w/ no thermometer but felt like I had a fever with chills, fatigue, wheezing, head ache that was not constant but hit spuratic from temples to back of head, thought I was feeling better 2/21/21 but symptoms returned and are continuing to current 2/23/21. My current symptoms; I woke up in the night w/loud wheezing continuing through the night and current worse at times when I'm up, some shortness of breath, some cough, some heavy chest feeling, I feel like I have a fever w/chills, fatigue, spuratic headache, cough, some blurred vision w/watery eyes and some crusting. I just feel flue like and want to rest. I have a doctor appt tomorrow 2/24/21 to get checked out. Just wanted to let you know my symptoms. I am healthy and do not take meds of any kind.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,OTH,none,none,psoriatic arthritis,,pyridium,"['Arthralgia', 'Chest discomfort', 'Chills', 'Cough', 'Dyspnoea', 'Eyelid margin crusting', 'Fatigue', 'Headache', 'Lacrimation increased', 'Neck pain', 'Pain', 'Pain in extremity', 'Pyrexia', 'Vision blurred', 'Wheezing']",2,MODERNA,SYR 1049988,OR,48.0,F,"Pt received dose 2 of Pfizer Covid vaccine at 12:00pm and soon after reported symptoms of nausea, SOB, wheezing, sweating, and numbness on left side from face to arm. Pt was given oxygen and 0.3mg of epinephrine was given intramuscularly at 12:05pm, followed by 25mg of diphenhydramine intramuscularly at 12:08, both administered by RN on site. Paramedics arrived at the scene at 12:05pm and took over monitoring of pt; pt was taken to ambulance at 12:10pm",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,SEN,None reported,None reported,None reported,,NKDA,"['Hyperhidrosis', 'Hypoaesthesia', 'Nausea', 'Wheezing']",2,PFIZER\BIONTECH,IM 1049989,NY,78.0,F,"Bad headache, dizziness, achy, vomiting (3x) Lasted until about midnight, Monday, Feb.22. Felt totally recovered by 9AM Tuesday.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/22/2021,1.0,SCH,"Gabapemtin, Metopropol. Meloxicam. Rovastatin, Vitamin D. Fish Oil. Tylenol Arthritis",None,Arthritis,,shell fish allergy,"['Dizziness', 'Headache', 'Pain', 'Vomiting']",2,MODERNA,IM 1049990,WY,74.0,F,Extremely tired and aches all over. Slight upset stomach. No appetite.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PVT,Metformin hcl 500 mg Atorvastatin 40 mg Lisinopril 20 mg,None,None,,None,"['Abdominal discomfort', 'Fatigue', 'Pain']",UNK,PFIZER\BIONTECH,SYR 1049991,CT,96.0,M,"4 days after receiving the vaccine in his left arm, my father developed a blood clot in his left arm that required emergency hospitalization and large doses of blood thinners.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/12/2021,02/16/2021,4.0,SEN,,None,,,None,['Thrombosis'],2,MODERNA,IM 1049992,OR,25.0,F,developed a lump over the left clavicle 24 hours after vaccination into ipsilateral deltoid,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/22/2021,1.0,UNK,alprazolam (XANAX) 0.5 MG tablet alprazolam 0.5 mg tablet TAKE 1 TABLET BY MOUTH DAILY AS NEEDED FOR ANXIETY norethindrone-ethinyl estradiol-iron (ESTROSTEP FE) 1-20/1-30/1-35 MG-MCG TABS Take by mouth daily sertraline (ZOLOFT) 25 MG tabl,none,none,,NKDA,['Lymphadenopathy'],2,MODERNA,IM 1049993,NY,66.0,F,"Injected on the top of my left shoulder? incorrect postision? After 3hours my left arm ?not injection area?very pain? weekness? unable to move? no fever?pain did not resolve after motrin and cold compress? Pain scale #10? seen doctor on 1/11/2021? pain released after Predisone?but returned when decrease predisone dosage? pain consistant ?unable to move? muscle weekness? seen neurolgist on 1/26/2021? EMG done? Dx Myositis? restarted Predisone and Gabapentine? MRI done? result negative?Pain resolved after Rx? Now pain and weakness decrease a lot, but still on Gabapentin once/ day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,PVT,Ambien 5mg? 5HPT? Famotidine 20mg? Montelukast 10mg? Vit D 2000u,Upper airway reaction? Acid reflex,Neck pain? Low back pain?,,none,"['Back pain', 'Electromyogram', 'Injection site movement impairment', 'Injection site muscle weakness', 'Injection site pain', 'Magnetic resonance imaging']",1,MODERNA,IM 1049994,IL,69.0,M,-soreness in arm muscle for 24 hours starting within a couple of hours of administration -about 16 hours after injection I had muscle and joint aching and very tender skin all over my body--symptoms lasted about 15 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PHM,,none,peripheral neuropathy,,none,"['Arthralgia', 'Myalgia', 'Tenderness']",2,PFIZER\BIONTECH,IM 1049995,NH,20.0,F,"Constant dizziness, unable to focus",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/15/2021,1.0,UNK,none,none,unknown autoimmune,,none,"['Disturbance in attention', 'Dizziness']",UNK,MODERNA,SYR 1049996,IL,82.0,F,"Muscle and joint aches, no fever, general tiredness. Went to bed, slept all night, felt pretty good when I woke up, felt fine by noon that day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,OTH,"Famotidine, levothyroxine, potassium, hydrochlorothiazide, Allegra, vitamin D3",None,"Kidney stones (stage 3 kidney disease), allergic rhinitis, PACs, mild COPD, irritable bowel syndrome, arthritis",,Sulfa Penicillin Codeine,"['Arthralgia', 'Fatigue', 'Myalgia']",2,MODERNA,SYR 1049997,SC,89.0,F,"Vaccine was administered at Nursing Facility. Patient is an 89-year-old female with prior medical history of CVA with dysphagia, history of possible dementia, GERD, hyperlipidemia, and a pacemaker. She is a resident from town. She was sent for hypotension with a blood pressure of 90/52, tachypnea respirations of 54, possible aspiration pneumonia. Status post Covid vaccine earlier today. History is limited as patient is nonverbal on my exam. Death within 24 hours of vaccination",Yes,01/08/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,OTH,"Pliavis, tramadol, aspirin, statin, remeron, protonix",none identified,"Heart Rhythm Irregularity, High Cholesterol, Arthritis, Hypertension, CVA/TIA/Stroke, GERD/Reflux, Sleep Apnea, Heart Disease",,"Ace inhibitors, solifenacin","['Aphasia', 'Death', 'Hypotension', 'Tachypnoea']",UNK,MODERNA,SYR 1049998,WA,78.0,F,"02/02- Shivering chills, 6 hrs.; muscle & joint pain, 4 days; excessive fatigue and cold, 2 1/2 weeks; fatigue continues; 02/10- injection sight red, feverish. appt. at urgent care 02/11. entire back of right arm infected, cellulitis. RX antibiotic. End of 10 days, cellulitis appears gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,02/02/2021,2.0,PVT,Methotrexate; lantanaprost; dorzolamide;preservision; B12; cal,None,Crohn's disease,,Codeine; penicillin,"['Arthralgia', 'Cellulitis', 'Chills', 'Fatigue', 'Injection site erythema', 'Localised infection', 'Myalgia', 'Nasopharyngitis', 'Pyrexia']",1,MODERNA,IM 1049999,SC,68.0,M,infraclavicular and sipraclavivular lymphadenopathy same side as vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/22/2021,2.0,PHM,"pravastatin, trilogy, albuterol inhaler",copd,copd,,none,['Lymphadenopathy'],1,MODERNA,IM 1050000,CA,72.0,M,"Possibly unrelated to the vaccine: 2, 5, and 8 days after the vaccine was administered, I experienced short but very painful episodes of abdominal pain, similar to gas pains. Each attack lasted 15 to 25 minutes, and seemed to be alleviated by taking anti-acid (simethicone) pills. Quite likely related the vaccine: 11 days after the vaccine was administered, I experienced a rather severe headache, plus slight general weakness, and a raised temperature of between 98.9 and 100.4 degrees. The first 10 days I had discerned no adverse effects. This has lasted16 hours so far, with little alleviation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/22/2021,11.0,OTH,NONE,NONE,Recently diagnosed (Dec 2020) Chronic Lymphocytic Leukemia (Stage 0),,NONE,"['Abdominal pain', 'Asthenia', 'Body temperature increased', 'Flatulence', 'Headache']",UNK,PFIZER\BIONTECH,IM 1050001,SC,32.0,F,Fatigue 2/18 5-8:30pm - went to sleep at 8:30pm Chills 2/18 8:00-8:30pm - went to sleep at 8:30pm Headache 2/18 4:00pm-3:00pm on 2/19 Neck joint soreness upon waking on 2/19 - 2/21 (ending around mid morning),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PUB,None,Cold,None,,None,"['Chills', 'Fatigue', 'Headache', 'Neck pain']",1,MODERNA,IM 1050002,CT,74.0,F,"Itching, swelling. redness around injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/14/2021,02/22/2021,8.0,PHM,None,none,none,,none,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 1050003,CA,77.0,F,Itchy rash around injection site. About 4? diameter,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,PVT,Levothyroxin Xarelto Losar tan,None,Thyroid under active High blood pressure,,None,"['Injection site pruritus', 'Injection site rash']",2,PFIZER\BIONTECH,IM 1050004,TX,40.0,M,"Headache, nausea, joint pain, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,PVT,,,,,,"['Arthralgia', 'Headache', 'Nausea', 'Pyrexia']",2,MODERNA,IM 1050005,TX,39.0,F,"Very minor chills, fatigue and muscle aches for about 3 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,WRK,None,None,None,,None,"['Chills', 'Fatigue', 'Myalgia']",UNK,PFIZER\BIONTECH,IM 1050006,,77.0,F,"patient reports swelling at vaccine site 1 week after vaccine administered. swelling accompanied by itching, headache and nausea x 1 day. redness remained for 4 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,02/05/2021,14.0,UNK,,,,,NKDA,"['Erythema', 'Headache', 'Injection site pruritus', 'Injection site swelling', 'Nausea']",UNK,MODERNA, 1050007,TX,52.0,M,"72 hours after injection severe abdominal rash, went to MD and was told it was related to vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/24/2021,3.0,PVT,,,,,,['Rash'],1,MODERNA,IM 1050008,AR,48.0,F,"Itchy, tingley, throat. Itchy bottom of feet. Drank water. Lasted ~20 minutes. No visible rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,WRK,Vitamins,None,Hypertension,,Latex,"['Paraesthesia', 'Pharyngeal paraesthesia', 'Throat irritation']",2,PFIZER\BIONTECH,IM 1050009,LA,65.0,F,Onset of Bell?s palsy 40 minutes after vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/09/2021,0.0,UNK,None,None,None,,None,"[""Bell's palsy""]",UNK,PFIZER\BIONTECH, 1050010,MN,50.0,F,"Moderna COVID-19 Vaccine EUA With my arm being covered I hadn't noticed the rash until today (10 days after the injection). My arm had been sore, but today I noticed a rash and I noticed by arm being itchy since yesterday.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/23/2021,10.0,OTH,none,none,none,,"penicillin, erythromycin","['Pain in extremity', 'Pruritus', 'Rash']",1,MODERNA,IM 1050011,CA,93.0,M,"LEFT FACIAL DROOPING, WEAKNESS LEFT EYELIDS, TEARING OF LEFT EYE, NUMBNESS LEFT SIDE OF FACE",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/20/2021,15.0,OTH,"HYDRALAZINE HCL 50 MG, FEBUXOSTAT 40 MG,AMLODIPINE 5 MG, ATORVASTATIN 20 MG, ASPIRIN 81 MG, FERROUS SULFATE 325 MG, MULTIVITAMIN, VITAMION C 500 MG,",NONE,"ANEMIA, CHRONIC KIDNEY DISEASE, LEUKOPENIA CHRONIC, HYPERLIPIDEMIA, PREDIABETES",,NONE KNOWN,"['Eye disorder', 'Facial paralysis', 'Hypoaesthesia', 'Lacrimation increased']",1,MODERNA,IM 1050012,OK,53.0,F,"2/19/21 � 6:30 pm start feeling fatigue. Right arm carpel tunnel started twitching randomly and frequently. This continued all evening and all the next day. 2/20/21 � Woke with fatigue, upper arm pain round injection site, muscle pain randomly over body, joint pain in previous arthritic sites. Continued all day randomly. General feeling of tiredness or unwell. Evening the pain worsed, muscles contracting around spine creating spinal pains and severe headaches. 2/21/21 � Woke feeling tired but better. 2/22/21 � In the evening started feeling pain in spine and muscles in middle to upper back and cervical region. Lymph nodes under jaws and side of neck are painful and inflamed. 2/23/21 � woke up feeling better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,"Nexium, Buspar, Wellbutrin, Tizandine",,"Morbid obesity, Reactive depression, Anxiety, Carpal Tunnel, Cervical spine disease, Sensory neuropathy, Cervical radi",,"Sulfa Drugs, Nickel, Hydrogenated Oils, Cellulose Gum","['Carpal tunnel syndrome', 'Fatigue', 'Injection site pain', 'Lymph node pain', 'Lymphadenitis', 'Malaise', 'Muscle contractions involuntary', 'Myalgia']",UNK,PFIZER\BIONTECH,IM 1050013,TX,48.0,M,Headache and nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,UNK,,,,,,"['Headache', 'Nausea']",2,MODERNA,IM 1050014,GA,93.0,F,"10 mins after injection, patient reported her tongue felt ""rough and swollen"". Reports being able to ""taste vaccine"". BP 189/110. 25mg benadryl given PO and patient given snack. Approximately 30 mins after injection, patient reports her tongue and lips were swelling. BP 170/128. Epi-pen administered, EMS called and patient transported to hospital at 12:45pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PUB,,,,,Iodine,"['Dysgeusia', 'Lip swelling', 'Swollen tongue', 'Tongue discomfort']",1,PFIZER\BIONTECH,IM 1050015,,56.0,F,"Fever of 100 degrees the day after vaccine and had muscle aches and then headaches. On the day after the vaccine, pain and redness/rash in left arm (lymph nodes) 4 inch long by 3 in. Red area has moved around the upper arm to a different spot on the left upper arm over the past three days. Red area is hot to touch and has not gone away yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,PHM,,none,none,,none,"['Erythema', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia', 'Rash', 'Skin warm']",2,MODERNA,IM 1050016,TX,61.0,M,Headache and nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,PVT,,,,,,"['Headache', 'Nausea']",2,MODERNA,IM 1050017,IN,81.0,F,"12:01 am 2-18-21 pt. felt sick went to bathroom, passed out and lost control of bowel. Said she felt like she had the ""flu"".",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/18/2021,1.0,PVT,"Levothyroxine 75 mcg daily, Risperidone .25mg, Simvastatin 40mg, Citalopram 40 mg, Gabapentin 300mg, Losartin 50mg, Eszopidione 2 mg, vitamin D3, B12, multivitamin, glucosamine, calcium, gabapentin",None,"hypothyroid, depression, anxiety, bad back",,Compazine,"['Anal incontinence', 'Influenza like illness', 'Loss of consciousness', 'Malaise']",2,MODERNA,IM 1050018,,24.0,F,"She received her vaccine on 2/17/2021 at 7:30 am. Immediately after receiving her vaccine, she started to feel lightheaded and stated she felt shortness of breath. She also felt her chest tight. She said she was monitored at the Vaccination Site for a longer period due to her feeling light headed, shortness of breath, and chest tightness. On 2/18/21, she still felt light headed. She started to feel fatigue and body aches from her waist up. On 2/18/ 21 she still felt lightheaded, fatigue, and body aches from her waist up. She treated these symptoms with ibuprofen. She felt lighted, fatigue. and body aches from her waist up for 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/17/2021,02/17/2021,0.0,UNK,,,,,,"['Chest discomfort', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Pain']",2,PFIZER\BIONTECH,IM 1050019,TX,60.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,PVT,,,,,,['Headache'],2,MODERNA,IM 1050021,NC,54.0,F,"Patient became mildly short of breath with some chest tightness and light headedness approximately 23 minutes after receipt of the vaccine. She notified the nursing counter who notified me. Patient was A&Ox3 upon my arrival and able to speak in full sentences. Heart rate was noted to be 105 bpm. 50mg oral Benadryl was administered and patient was monitored for 25 minutes. Heart rate improved as did patient's work of breathing, chest tightness, and her dizziness subsided completely. Her final heart rate at time of discharge was 93 bpm and patient was able to ambulate under own power to depart the site. She was escorted to her husband's vehicle and he received instructions to take her to the hospital to fill her epi-pen prescription which was placed at the time of the incident as well as reasons to use the epi-pen and report to ED if needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,MIL,"Prazosin, Detrol, Bupropion XL, Montelukast, Cetirizine, Escitalopram, Climara, Progesterone, Premerin, Toperamate",None,"Asthma, anxiety, adjustment disorder, ADHD, depression, hyperlipidemia, insomnia, IBS, skin cancer","influenza and smallpox, both required epi-pen administration (per patient)","Egg, Penicillin, Macrolides, Codeine, Influenza vaccine, Keflex, Iodine, Levofloxacin","['Chest discomfort', 'Dizziness', 'Dyspnoea']",1,PFIZER\BIONTECH,IM 1050022,CT,28.0,M,Administration Error-vaccine dose not delivered.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PVT,,,,,,['Product dose omission issue'],2,MODERNA,IM 1050023,,59.0,F,"Nausea, stomach cramps, body aches, and fatique",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,PVT,,,,,,"['Abdominal pain upper', 'Fatigue', 'Nausea', 'Pain']",2,MODERNA,IM 1050024,,45.0,F,Migraine Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,,,,,,['Migraine'],1,MODERNA,IM 1050025,,46.0,F,"Headache, nausea, and fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,PVT,,,,,,"['Headache', 'Nausea', 'Pyrexia']",2,MODERNA,IM 1050026,NY,68.0,F,"One week after shot was given, large, red, itchy spot appeared on right arm by injection site. By the evening, the itchiness had continued and skin felt hot. Right hand also felt almost ""swollen"". I took an antihistamine that evening and it felt better. 3 days later, the patch is lighter in color. less itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,PHM,Vitamin D,None,Raynauds Syndrome,"Shingles vaccine, both doses- 2 days of severe headache, body aches, nausea, fever",Sulfa drugs,"['Injection site erythema', 'Injection site pruritus', 'Injection site warmth', 'Peripheral swelling']",1,MODERNA,SYR 1050027,CA,73.0,M,Fall with temperature of 99.5. Low grade temperature continued for several hours. He appeared to be more fatigued and weaker.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/21/2021,1.0,PVT,atovastatin 20mg QHS finasteride 5mg QDay flecainide 25mg BID lisinopril 10mg BID metformin 1000mg BID metoprolol succinate 25mg BID olanzapine 10mg QHS rivaroxaban 20mg QDay valproic acid 2500mg QHS,,"hyperlipidemia, BPH, A-fib, hypertension, diabetes II, urinary catheter, bipolar disorder, recent urolift surgery, previous COVID-19 with acute hospitalization",,NKA,"['Asthenia', 'Fall', 'Fatigue', 'Pyrexia']",1,MODERNA,IM 1050028,CA,76.0,M,"Bell's Palsey, paralysis left side of face",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,PVT,fish oil on blood thinners and high blood pressure medication,attack of gout in the foot (first episode ever) one week after receive first dose of Moderna Covid vaccine,afib (treated) high blood pressure (treated),1st ever attack of Gout to right foot 1 week after first dose of Moderna Covid vaccine,allergies to almonds,"[""Bell's palsy"", 'Facial paralysis']",UNK,MODERNA,SYR 1050029,,54.0,F,Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,PVT,,,,,,['Headache'],2,MODERNA,IM 1050030,CA,63.0,M,"pt lost consciousness immediately after injection. Code blue team was called, provider assessed. Once pt regained consciousness he was transferred to hospital for f/u care.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,PVT,,,,,,['Loss of consciousness'],1,MODERNA,IM 1050031,TX,72.0,F,"Itch at injection site, swelling and rash now day 7",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/17/2021,7.0,OTH,"valsartin, armour thyroid, Vitamin D, multivitamin,",none,"hypertension, hypothyroid",,none,"['Injection site pruritus', 'Injection site rash', 'Injection site swelling']",UNK,MODERNA, 1050032,,49.0,M,"Patient became nauseated, feverish, severe heartburn which has remained 15+ hours later.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/23/2021,1.0,PVT,,,,,,"['Dyspepsia', 'Nausea', 'Pyrexia']",UNK,MODERNA, 1050033,VA,44.0,F,"While taking a shower I noticed that my arms had a rash in various spots. Then I noticed I had other spots on my thighs and around my underwear line. The rash was worst on my arm that got the injection. After being out of the shower for about 30 minutes, the rash lightened in color but is still there now.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/22/2021,5.0,OTH,Multivitamin,None,None,,None,['Rash'],UNK,MODERNA,SYR 1050034,FL,73.0,F,"Red inflamed 5"" x 2"" hot reaction at injection site. No pain itching or swelling. Temperature of ~100 F",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/22/2021,7.0,OTH,"Revlimid, Kyprolis, Dexamethasone, iron, Acyclovir. Aspirin 81mg, cyclobenzaprin, amoxicillum, tylenol, Multivitamins",Severe anemia (had 2 units PRBC) on 2/19/2021,Multiple Myeloma (Dec 2014) to present,,"Cats, penicillum, Deamethasone","['Body temperature increased', 'Injection site erythema', 'Injection site warmth']",2,PFIZER\BIONTECH,IM 1050035,CA,44.0,M,"Patient states he had vaccination at 1030 today and did not want to wait the recommended observation time of 15 minutes in the hospital lobby. He is currently a highway patrol officer. While driving in his patrol car, at 1035, he felt tightness in the back of his neck and tightness to his airway- he described it feeling like someone hit him in the neck. He denied having any trouble breathing. Later, he noted his hand was twitching. 1045, he came back to lobby and made an RN aware who brought him to employee health. He declined to go to ED (I found out later). BP was 153/115 HR 102 initially, no hx of high bp. No noted hives or swelling to face or mouth/tongue or L deltoid region. Pt. denied feeling any itching anywhere. Pt. rested for about 15 minutes on exam table. Re-check of BP was 151/113 HR 84. Pt. states he feels better and feel like that feeling of tightness in his neck is decreasing. Made aware to follow up with PCP regarding BP and giving informational handout regarding blood pressure. RN recommended he go to any ED if he has any trouble breathing, swelling of tongue, etc at any time after he leaves this hospital. Pt. verbalized understanding.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PVT,None,None,None- states he does smoke.,,None,"['Blood pressure increased', 'Chest discomfort', 'Muscle tightness', 'Muscle twitching']",2,PFIZER\BIONTECH,IM 1050036,AL,69.0,F,"Circular 3.5"" dark, itchy spot on arm. Itching was extremely severe. Area is still noticeable but light in color. Wonder if my skin tissue has been affected?",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/16/2021,7.0,UNK,"Rosuvastatin 20mg, TRIAMT/HCTZ 37 5.25mg",None,None,,None,"['Pruritus', 'Skin discolouration']",1,MODERNA,SYR 1050037,SC,68.0,M,"COVID arm. Red 2"" diameter area around injection that appeared 11 days after injection. No pain, no itching, no worries. Simply a distinct red circular area around vaccine injection point. No other side effects of any kind. Just reporting the red arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/23/2021,11.0,PHM,None,None,None,,None,['Injection site erythema'],UNK,MODERNA, 1050038,SC,40.0,F,"Two days after the dose in my right arm, I had a nerve or a muscle that was twitching that lasted for the three weeks until I got my second dose in my left arm. The left arm just had a normal aching for 24 hours. My right arm has rapid twitches like once or twice a day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,02/12/2021,32.0,PVT,No,No,Anxiety,,Lortab and fentanyl,"['Muscle twitching', 'Pain in extremity']",2,PFIZER\BIONTECH, 1050039,NJ,36.0,F,"Staff reports feeling nauseaus, vomitted, shivers and general body aches, had a hypertensive episode BP of 150/100 at around 7:30am, was offered to be sent to hospital ER, was discharged from the hospital the same day with no new recommendations. Staff sent to hospital ER for evaluation, no new recommendation made, no further symptom reported",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/05/2021,02/06/2021,1.0,UNK,,,,,,"['Chills', 'Hypertension', 'Nausea', 'Pain', 'Vomiting']",2,PFIZER\BIONTECH,IM 1050040,,69.0,M,Feel dizzy when I get out of bed in the morning. I also feel dizzy when I exercise.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/16/2021,5.0,UNK,None,none,none,,grass and tree pollen,['Dizziness'],UNK,PFIZER\BIONTECH, 1050041,NY,83.0,M,NO ADVERSE EVENT --I DON'T KNOW HOW TO GET RID OF IT.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/23/2021,,,UNK,lisinioril 20/25 l /da tramadol 50 mg tamsulosin .4 mg l/da turmeric--voltaren a needed gabapentin 600mg l/dd omeprazole 40 mg l/da simvastatin 40 mg l/da,neuropathy essential hypertension atrial fibrillation,,,morphine naproxim penicillins,['No adverse event'],UNK,MODERNA, 1050042,AZ,47.0,F,"I had extreme body aches, chills, fever up to 101.9, headaches. Nauseous after vaccine and vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,WRK,"Sudafed, zyrtec, fluconazole, famotidine, probiotic, benadryl",Symptoms similar 1st vaccine,None,Same,No known,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",UNK,MODERNA,SYR 1050043,MS,58.0,F,"Received second Covid vaccine at ~1:45pm and was monitored x 15 minutes without difficulty. She reports that about 2:15pm while she was on her way home, she developed some chest fullness/tightness and some mild SOB. She returned to Vaccine clinic for evaluation. She was able to park and walk-in unassisted. Denies throat itching/swelling No rash Vitals: Initial set 115/66, HR 70, RR 18, O2 sat 99% Continuous pulse oximetry with oxygen sats 99-100% and HR 70-75. � Gen: WDWN WF NAD, conversing easily without dyspnea. CV: RRR no MGR Resp: CTA bilaterally, no increased WOB Skin: warm, dry, not diaphoretic, no rash Neuro: afocal,MAE � Fingerstick glucose: 89 � Monitored x 15 minutes with significant improvement and resolution of chest discomfort and SOB Discussed with medical director and transferred to employee health for additional 30 minutes of monitoring. Monitored x 30 minutes in SEH. Complete resolution of symptoms. Vitals q 15 minutes x 2 @1513 133/69 HR 71 @ 121/65 HR 72 Cleared to return home. Discussed signs necessitating emergent treatment including chest pain, SOB, throat swelling/itching.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,WRK,Vivelle Dot Singulair,None,Allergies,,Augmentin (rash),"['Blood glucose normal', 'Chest discomfort', 'Dyspnoea']",2,PFIZER\BIONTECH,IM 1050044,CA,76.0,F,Left arm began to itch and ache at injection site. Symptoms were mild. I rubbed with hydrocortisone creme that night and the next morning. It seemed to help and the itching and aching decreased through the day.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/19/2021,9.0,PHM,Dicoflenac,None,Arthritis,,Crab,"['Injection site pain', 'Injection site pruritus']",1,MODERNA, 1050045,NY,54.0,F,"Patient developed red rash neck, chest and arms. Bilateral Eye swelling. Chest tightness. Denied difficulty breathing. Benadryl 25mg IM administered and transferred to Emergency Room for further treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PVT,None,none,none,,"Motrin, sulfa, bees, peanut allergy started 1 week ago","['Chest discomfort', 'Eye swelling', 'Rash erythematous']",1,PFIZER\BIONTECH,IM 1050047,OR,32.0,F,"COVID arm. Swollen red patch near injection site that itches and aches. Grew over 24 hours, now is over an inch in diameter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/22/2021,7.0,PHM,"Labetatol, and antihistamine.",Cold (prior).,High blood pressure.,"Flu shot, October 2016.",Pistachios.,"['Injection site discolouration', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,SYR 1050048,OK,42.0,F,"I woke up at 4:30am to shower. Once in the shower I got lightheaded, yelled for my husband, and as he was getting there I fainted in the shower. I came to, rested a second but when he helped me up I fainted a second time. Laid in bed for several hours. Took blood pressure/heart rate around noon and heart rate was 115.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/23/2021,1.0,OTH,Estarylla (birth control) Atenolol (blood pressure),,,,None,"['Dizziness', 'Syncope']",1,PFIZER\BIONTECH,SYR 1050049,WA,44.0,F,"I was given my 2nd dose of Covid-19 vaccine on 10 Feb 2021 at about 0800 am, I stayed at the facility for 15 minutes and did not have any issues at that time. My arm was a bit sore and I felt tired for a couple days following the 2nd vaccine. On 12 Feb early afternoon (around 1100am), I noticed I was dizzy and feeling a bit nauseated like I had motion sickness. I already had the following week off work, so I napped when I could. I have been tired as well. I have been experiencing waves of dizziness daily now since 12 Feb (today marks the 12th day). I spoke with my PCM's team at the Spokane VAMC and they recommended I try to take Meclizine at night to see if I improve. I was advised to have someone drive me to urgent care if my condition worsens where I lose consciousness, faint, or cannot stand up straight.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/12/2021,2.0,MIL,"RX 1 injection every 12 weeks -Ustekinumab (Stelara) 90, (last injection on 29 January 2021) RX once daily in AM -Propanolol - 60 mg/24 hr cap -Pantoprazole - 40 mg -Cetirizine - 10 mg -Famotidine - 20 mg tab -Vitamin K - 10 Meq tab -Vit",- Fibromyalgia - Psoriosis - GERD - Chronic Pain (primarily Achilles and back),- Fibromyalgia - Psoriosis - GERD - Chronic Pain (primarily Achilles and back),,-Propyl Gallate -Nickel,"['Dizziness', 'Fatigue', 'Motion sickness', 'Nausea', 'Pain in extremity']",2,PFIZER\BIONTECH,SYR 1050050,IN,65.0,M,"Chills, headache, diarrhea, dizziness, extreme arm pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PHM,"Metformin, Synthroid and Coqu10.",None,Hypothyroidism.,,None,"['Chills', 'Diarrhoea', 'Dizziness', 'Headache', 'Pain in extremity']",1,MODERNA,SYR 1050051,TX,76.0,F,2-3 days after the vaccine patient broke out in shingles on right arm (same as vaccination site) from shoulder to right thumb,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/31/2021,2.0,PVT,"Amlodipine, Albuterol HFA, Atorvastatin Fluticasone Nasal spray, Losartan, Metformin, Escitalopram, Montelukast, KCL, dyazide, Trazodone, Super B complet, Calcium with Vit D, Iron, Probiotics",none,"Type 2 DM, HTN, hyperlipidemia, Asthma, CKD, hx +TB test in 1990s-treated/, mild anemia (Hgb 11.3) with low B12 and low Fe",,Aspirin (rash) Ibuprofen (rash) Glimepiride (angioedema),"['Herpes zoster', 'Injection site rash']",1,MODERNA,IM 1050052,CA,36.0,F,Herpes simplex 1 outbreak of oral lesions 48 Hours after receiving vaccine Arm soreness and nausea 24 hours after receiving vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/14/2021,2.0,WRK,"Prenatal, vitamin D, vitamin B6, aspirin",None,None,,None,"['Herpes simplex', 'Nausea', 'Oral disorder', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 1050053,WI,83.0,F,"I had a red rash on the left arm ,but not at the site of the injection. It itched for two days. Was red for about 6 days and gradually faded. It's 3 weeks and still is visible.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/09/2021,7.0,PVT,"Pantoprazole 40mg. /. Venlafaxine ER 37.5mg. /. Latanoprost 0.005 percent ophth sol. / Vitamin C, B12, D3, Benefiber",None,"I have one kidney,. Right one removed in 1974",,"Codeine,. Sulpha, minocycline","['Rash', 'Rash erythematous', 'Rash pruritic']",,MODERNA,IM 1050054,MA,62.0,F,"Fever 102 to 104.3, severe muscle & joint pain, lethargy x 24 hours, Fever 101 to 102.4, muscle & joint aches, fatigue, mild swelling, soreness & redness at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,WRK,None,None,None,,None,"['Arthralgia', 'Fatigue', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Lethargy', 'Myalgia', 'Pyrexia']",2,MODERNA,IM 1050055,CO,73.0,F,13 days later patient is experiencing redness at the injection site as well as a feeling of a knot during palpation. The site also feels warm to the touch and patient feels like it is warm also,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,02/11/2021,1.0,PHM,metoprolol tartrate 50mg bid atorvastatin 40 1qd lisinopril 20mg 1qd,UTI,,,none,"['Injection site erythema', 'Injection site mass', 'Injection site warmth']",1,MODERNA,IM 1050056,NM,74.0,M,HIves lasted for 24 hours and resolved with antihistamine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/11/2021,2.0,PVT,Crestor Eztemibe Xarelto Vit D Zinc AREDS 2,,,,,['Urticaria'],2,PFIZER\BIONTECH,IM 1050057,CA,54.0,F,"Rash and soreness at first, seven days later swelling, large round welt and itching",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,OTH,"Grastek, premarin , Qvar, albuterol, losartan potassium, flonase, iron and calcium",None,"Asthma, allergies and hypertension",,"Penicillin, sulfates, grass, trees and weeds","['Pain', 'Pruritus', 'Rash', 'Swelling', 'Urticaria']",1,MODERNA,SYR 1050058,FL,73.0,F,"?Covid Arm? Red rash from injection site almost to my elbow. This started the day after shot and has not gone away in 5 days so far. No sign of disappearing. I also had sore muscles and fatigue the day after, but these lasted just 1 day and were gone. This was my 2nd dose.....No problems with my 1st dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,PHM,Simvastin 20mg Hydrochlorothiazide 12:5 mg Complete Multivitamin - Women 50+ Calcium 600mg,None,None,,None,"['Fatigue', 'Injection site rash', 'Myalgia', 'Rash erythematous']",UNK,MODERNA, 1050059,RI,49.0,F,I began a rash on my left leg after 1st vaccination on 1/16/2021. I had two telahealth appointments with my primary doctor do itch an pain. They thought maybe it was shingles and treated as that. A week later I began to break out in hives on both arms and legs. My doctor prescribed amoxicillin and a medication for itch. Had no relief. I got my second Moderna vaccine on 2/13/2021 and the hives on my arms and legs became worse. I made an appointment at the walk-in of Medical to be seen in person as I couldn?t take the itch and pain. I was perceived prednisone for two weeks and itch ointment. I started dose yesterday and felt immediate relief this morning when I woke up. I just wanted to report this to see if anyone else has had this same side effect to the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/20/2021,4.0,PVT,,,Epilepsy,,,"['Pain', 'Pruritus', 'Rash', 'Urticaria']",2,MODERNA,SYR 1050060,PA,63.0,M,"Right shoulder pain, right flank pain, midback pain, right knee pain. Started AM on 2/19/2021. Worsened, unable to move right arm ,pain hindered mobility for walking, unable to bend sue to back pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,WRK,,,,,,"['Arthralgia', 'Back pain', 'Flank pain', 'Mobility decreased', 'Pain']",2,PFIZER\BIONTECH,IM 1050061,NM,79.0,F,"pt reported that 10 days after vaccine she had a delayed reaction of itching, swelling, a knot, and feeling warm in where the injection was given. She also reported neck pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,02/04/2021,9.0,UNK,Unkown,None known,none known,"Pneumonia vaccine, 13 years ago, similar reaction.",NKA,"['Injection site mass', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth', 'Neck pain', 'Skin reaction']",1,MODERNA,IM 1050062,NH,67.0,F,Patient developed tingling throughout her left arm and hand shortly after injection. She denied any strength or sensation deficits. She reported that the symptoms were relatively minor but were not improving. She was encouraged to follow up with her PCP.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,OTH,none,none,none,,none,['Paraesthesia'],1,PFIZER\BIONTECH,IM 1050063,AZ,59.0,F,"With my second shot after eight hours of no symptoms, I had a fever of 101.8 and slept in a very deep sleep for 48 hours. I woke to drink water and use restroom only. On Monday morning I woke up soaked in sweat that smelled like vinegar and the fever was gone. My first shot I had a little soreness in my arm only.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,OTH,Emergen-C Elderberry Immune Support Gummies X2 daily,None,None,,None-Sensitive to Penicillin(stomach ache),"['Hypersomnia', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1050064,KS,80.0,M,Resident with acute onset of SOA this AM with Sao2 of 65%. Transfered to ER with diagnosis of bilateral pulmonary embolism,Not Reported,,Yes,Yes,,Not Reported,U,02/18/2021,02/23/2021,5.0,SEN,MVI 1 tab daily in AM,none,"COPD; Post Polio syndrome; MDD; Alzheimer's disease; EPILEPSY, UNSPECIFIED, NOT INTRACTABLE, WITHOUT STATUS EPILEPTICUS; OTHER SEIZURES; PERSONAL HISTORY OF OTHER DISEASES OF THE CIRCULATORY SYSTEM;",,NKA,"['Dyspnoea', 'Oxygen saturation decreased', 'Pulmonary embolism']",2,PFIZER\BIONTECH,IM 1050065,WA,35.0,F,"Around lunch time on the 9th of Jan . I noticed all over body rash, macular papular rash redish whitish throughout body, it became very itchy in my arms and legs, I noticed numbness in right and left arm and legs numbness, shooting pain in left side as well, I experienced neurological symptoms and went to ER. They did a complete blood count and basic metabolic panel, they said it was probably a immune response and was told to take antihistamines at home. symptoms started to subside after a couple of days, I then developed intermittent chest pains in the left side and the pain became more consistent and then a week later it was consistent with every breath and I went to the ER again, they did an EKG, Troponin, all cadiac workup and chest xray said it was not cardiac but possibly a chest wall issue, I was referred to cardiology, cardiologist thought I may have pericarditis, I started taking 800mg of ibuprofen for management. My pain has began to subside and now I only have a couple of minutes every other day that I still have pain but stopped taking medication the third week in February. Because of the intensity of my immune response they recommended I not take the 2nd dose. If symptoms subside I will let my dr know",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/09/2021,3.0,PVT,no,no,no,,no,"['Chest X-ray normal', 'Chest pain', 'Electrocardiogram normal', 'Full blood count normal', 'Hypoaesthesia', 'Metabolic function test', 'Neurological symptom', 'Pain', 'Pruritus', 'Rash macular', 'Troponin normal']",1,MODERNA,SYR 1050066,AZ,57.0,F,"Very Bad nausea, Severe Vertigo, Bad Headaches, Blurred vision I was hospitalized at Hospital for 1.5 days. But the fields in question 21 would not allow me to enter the information when I checked Hospitalization. I received the vaccination at the Stadium in which was a State run POD.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/14/2021,02/16/2021,2.0,OTH,"Ocrevus, Zoloft, Vitamin D, IVIG",Patient has MS,Patient has MS,,None,"['Blood test', 'Headache', 'Magnetic resonance imaging', 'Nausea', 'Vertigo', 'Vision blurred']",2,PFIZER\BIONTECH,IM 1050067,VA,31.0,M,"Fever, chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/04/2021,1.0,PUB,None,None,None,,None,"['Chills', 'Fatigue', 'Pyrexia']",UNK,MODERNA,IM 1050068,WI,59.0,F,Patient complained of fingers and feet turning purplish/black starting about 24 hrs after it was given and it took a few days for it to go away completely. She also felt some tingling sensations but said she has some neuropathy.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/27/2021,1.0,PHM,Diabetic on medication but unsure of what ones.,Diabetes and neuropathy,Diabetes and neuropathy,,Unsure,"['Paraesthesia', 'Skin discolouration']",1,MODERNA,IM 1050069,OH,79.0,F,"Redness, hard swelling, itching -- swelling lasted about 2 days and the redness diminished over about 5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/31/2021,02/09/2021,9.0,PHM,"nifedipine, quinapril, hydrochloric, synthroid",--,high blood pressure,,sulfa--,"['Erythema', 'Induration', 'Swelling']",UNK,MODERNA,IM 1050070,NC,66.0,M,Extreme fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/14/2021,1.0,PVT,atorvastatin ?LIPITOR? 20 MG tablet ?Started 9/8/2014? Take 20 mg by mouth once daily. reported on 12/13/2016 omeprazole ?PRILOSEC? 20 MG DR capsule ?Started 9/8/2014? Take 20 mg by mouth continuously as needed. reported on 12/13/2016 co?en,,"Low Back Pain, Sleep Apnea",,NKA,['Fatigue'],1,MODERNA,IM 1050071,TX,35.0,F,"Hives, Angioedema, slight cough and wheezing",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/03/2021,0.0,PVT,,,,,,"['Angioedema', 'Cough', 'Urticaria', 'Wheezing']",1,PFIZER\BIONTECH,IM 1050074,MD,79.0,M,"Passed out, I.V. and fluids, transported to the hospital",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,OTH,,"Hypertension, diabetes, other unknown heart condition","Hypertension, diabetes, other unknown heart condition",,,['Loss of consciousness'],1,MODERNA,IM 1050075,CA,64.0,F,"First one muscle ache, head ache, itchy at vaccine site, fatigue and inflammation. Second one First one muscle ache, head ache, itchy at on buttocks and leg a site, fatigue and inflammation. To off work slept 12 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/21/2021,3.0,UNK,,,,,,"['Fatigue', 'Headache', 'Inflammation', 'Injection site pruritus', 'Myalgia']",2,MODERNA,SYR 1050076,DE,51.0,F,"I submitted my last V safe survey on 2/19. A few hours later I developed a swollen lymph node above my clavicle on the left side. On Sunday the 21st, I have a large lump under my right jaw bone which I?m assuming is another swollen lymph node. The lymph node above my clavicle is tender To the touch and has not reduced in size.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,OTH,Robitussin,No,None impacting issue,,None,"['Lymph node pain', 'Lymphadenopathy', 'Swelling face']",1,MODERNA, 1050077,NY,60.0,F,Pain in arm immediately after and than loss of movement of arm next day,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/09/2021,0.0,PVT,,,,,,"['Immediate post-injection reaction', 'Injected limb mobility decreased', 'Pain in extremity']",2,MODERNA,IM 1050078,MT,92.0,F,"Patient hospitalized after first dose, but before second dose.",Not Reported,,Not Reported,Yes,4.0,Not Reported,,12/29/2020,01/18/2021,20.0,PUB,,,,,,"['Hospitalisation', 'Vaccination complication']",UNK,PFIZER\BIONTECH, 1050079,CA,49.0,F,"rash and hives in different parts of the body. Symptoms are similar to chronic urticaria. Other potential allergens have been removed, such as switching to hypoallergic soaps, shampoo, laundry detergent, and dryer sheets.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/12/2021,1.0,PVT,none,rash/ hives approx. 1 week after the first dose of Moderna vaccine,,,nka,"['Rash', 'Urticaria']",UNK,MODERNA,IM 1050080,,34.0,F,Tachycardia HR 150s for 10 minutes associated with headache that awoke patient from sleep. Self resolved. EKG normal later that day and cardiac exam normal,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/23/2021,4.0,PVT,none,none,none,,none,"['Electrocardiogram normal', 'Headache', 'Tachycardia']",UNK,MODERNA, 1050082,NY,50.0,F,Large red approximately 8 -10 inches in diameter circle inches harden swollen red patch around the injection site on left arm. Warm to the touch. Getting larger by the day. Will seek medical treatment by Thursday. Appeared days ago ...about a week after injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/19/2021,8.0,SCH,Eliquis B12 injection quisimia,Sarcoidosis,Chronic Bronchitis,,None,"['Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 1050083,WA,30.0,F,"Arm soreness started 2-3 hours after injection. Intense body aches down spine and legs started 12 hours post-vaccine injection along with fever, chills, and headache. Body aches lasted for 24 hours. Fatigue lasted 3 days and had a strong headache that got worst with change of position 4 days after injection that lasted 18 hours. Returned to normal 5 days post injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,PVT,"sertraline, montelukast, skyla IUD",n/a.,n/a.,,pencilin,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",2,MODERNA,SYR 1050084,WI,73.0,F,"Symptoms: Rash, Hives,Swelling of lips occurred 9 days following first vaccination. Contacted doctor 3 days after symptoms began. Treatment: Doctor recommended starting Antihistamine and continuing through second vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,02/18/2021,9.0,OTH,Levothyroxine Estrodial,None,Reynauds syndrome,,None,"['Lip swelling', 'Rash', 'Urticaria']",1,MODERNA,SYR 1050085,,33.0,F,"Received her vaccine on 02/09/21 at 3:00pm and started to feel fatigue, nauseous, and had body aches. At 6:00pm, she had a headache that lasted until Thursday evening (2/11/2021). On 02/09/21 her fever and chills began at 8:00pm and lasted until 02/10/21 3:00pm. She treated her fever with Tylenol and her body aches with Advil. On 02/10/21, she had diarrhea that lasted 6 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/09/2021,02/09/2021,0.0,UNK,,,,,,"['Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,IM 1050086,MT,86.0,M,"Several hours after receiving the vaccine, patient developed a swollen tongue and was admitted over night to the hospital for observation.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/16/2021,02/17/2021,1.0,UNK,Lisinopril,,Hypertension MS,,Morphine,['Swollen tongue'],2,MODERNA,IM 1050087,MT,83.0,F,"Patient hospitalized after first dose, but before second dose.",Not Reported,,Not Reported,Yes,4.0,Not Reported,,02/09/2021,02/16/2021,7.0,PUB,,,,,,['Hospitalisation'],UNK,PFIZER\BIONTECH, 1050088,ND,84.0,F,"The client's daughter reported that the day following vaccination the client experience tremors all extremities bilaterally for approximately 24 hours. She reports the client stated the tremors were not ""chills"" but were uncontrollable tremors. No residual effects noted once they subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PUB,Unknown,None at time of vaccination. Month prior unknown,None,,None,['Tremor'],2,MODERNA,IM 1050089,CA,67.0,F,"On 2.23.21 at approximately 1 PM, Vaccine lead, , RN, was notified by temp nurse, , RN did an incorrect vaccine was administered on Upon review of vaccine card, RN discovered that client, received a first dose Moderna Vaccine at Site and was given a second dose of Pfizer vaccine. Client denies any adverse reactions and was observed post vaccine for 30 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,OTH,Unknown,None,None,,None,"['Interchange of vaccine products', 'No adverse event']",1,PFIZER\BIONTECH,IM 1050090,WV,59.0,F,"A later the day after the vaccine I was very fatigued and by the 3rd day I had chills so bad I was shaking. I had a severe headache which felt worse than any migrane headache ever. Body aches, fever of 100.4 and nausea which caused me to have to take off work. I was tested for COVID-19 which was negative and I had a pounding HR as well which all symptoms pasted after about 2 1/2 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/11/2021,3.0,SCH,"Sintyroid, Losartan, 325 mg aspirin, metroprol, Vit D., fish oil, protonics, Xanax",UTI,"Stents in the Heart, Fibroids, Tyroid issues. IBS, Fibromyalgia, Hypertension, Diabetic-Controlled, sleep apnea",,"IVP dyes, Amoxicillin, Zanaflex, Bactruim, Viaxin, Cinnamon, Raisin, Cypro","['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Palpitations', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tremor']",1,MODERNA,IM 1050091,OK,43.0,F,"Patient became pale, cold, clammy with shortness of breath after getting vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/23/2021,02/23/2021,0.0,PVT,,none stated,,,"Depo-Provera, Shrimp, nitrofurantoin","['Cold sweat', 'Dyspnoea', 'Nasopharyngitis', 'Pallor']",1,MODERNA,IM 1050093,CO,71.0,F,"Severe chills, fever, vomiting, headache, loss of all urinary control, exhaustion. Lasted 3 days. (Tapered off after about 8 hours). Called doctor and was told to take Tylenol, which I did.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,PVT,"Prednisone, venlafaxine, trazodone, thyroxine, multivitamin, vitamin D",,auto-immune disease = PMR (polymyalgia rheumatica),"When I was 13, I got typhoid fever from a typhoid shot",none,"['Chills', 'Fatigue', 'Headache', 'Pyrexia', 'Urinary incontinence', 'Vomiting']",2,MODERNA,SYR 1050094,,36.0,F,"Approximately 12 hours after (so around 230am) receiving my second Moderna vaccine, my arm became painful and woke me up in the middle of the night. I didn?t look at my skin yet, and went back to sleep. At around 838am I was changing and though my arm was still very painful to move (more painful than any shot I?ve ever had ) , I took my long sleeve shirt off and noticed an inch wide red splotch that was warm to the touch and 1/3 of a golf ball sized lump was on my right arm under the red splotch. I took Tylenol, and used ice packs throughout the day. The next day the lump was still the same size and the redness was a shade darker. I had a family member mark a border with pen around the red area. About another 12 hours later the area of redness outgrew the pen marked area to about 1 1/2 inches in diameter. Day 3 post vaccination, my arm splotch has grown to 2 inches and is still red but also started itching today. The hardness is there as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,PUB,Levothyroxine,,Hypothyroidism,,"Sulfa, Reglan","['Injection site erythema', 'Injection site mass', 'Injection site movement impairment', 'Injection site pain']",2,MODERNA,IM 1050095,NM,30.0,F,"1415: Patient with history of COVID 8/2020 presented today for second dose of vaccine after approximately 5 minutes after patient had vaccine patient had syncopal episode, itching/ fullness. Covering physician present and assessed with EMS on Duty: VS: 110/80-BP, 18-RR, 96-HR, SaO2-98% on RA, CBG: 138 Patient awakened and reported ""feeling funny"" but was A & Ox4, MAEW x4 with equal strength, Lungs Clear to auscultation. 1420: Benadryl liquid PO given along with 8oz of water. Patient able to drink without issues. 1500: EMS called for ER transport to due prolonged recovery.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,PUB,"famotidine 20mg qday, methylphenidate 27mg ER qam, fludrocortisone 0.1mg qday, omeprazole 20mg qday, Pristiq 100mg qday, Rexulti 3mg qday, folic acid 1mg qday",unknown,"TBI 2007 after MVA(CHI) Vagovasal syncope, ADHD",,"ibuprofen (unknown reaction)., milk products (unknown reaction)","['Feeling abnormal', 'Pruritus', 'Syncope']",2,PFIZER\BIONTECH,IM 1050097,CA,,F,Slight swelling redness itch,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/14/2021,02/21/2021,7.0,PHM,,,,,,"['Erythema', 'Pruritus', 'Swelling']",1,MODERNA,IM 1050098,CA,66.0,F,"flu like symptoms, no fever/ chills, sleepy, couldn't stay awake,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/21/2020,12/22/2020,1.0,PVT,"simvastatin 40mg daily Plavix 75mg daily altace 5mg daily calcium 1200mg daily vitamin d3 10,000 mg daily pro air hfa 2 puffs q 5 minutes q 4 hours",none,"hypertension, hyperlipidemia, stroke/ mi, asthma,",,"Bactrim , sulfa, latex,","['Influenza like illness', 'Somnolence']",1,PFIZER\BIONTECH,IM 1050099,ID,58.0,F,"Client was mistakenly administered a Moderna, Dose #2, rather than the Pfizer, dose #2 . After it was given and the mistake was realized, client was notified of the incident, information was corrected on her imm. card, and advised her that she would not need another dose of Pfizer, that her series is complete.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,PUB,,,,,,['Product administration error'],2,MODERNA,IM 1050100,FL,77.0,F,Mild temperature as high as 101 for 3 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,OTH,"Amitriptyline, Klonipin, generic Fosamax, Biotin, Vit D ,Preservision, Monoxidil/ Finaster",No,No,,Penicillin,['Body temperature increased'],1,PFIZER\BIONTECH,IM 1050101,CO,28.0,M,"Pt states he was initially feeling fine s/p receiving his COVID vaccine. After 5-6 minutes he notes a syncopal episode that he describes as feeling like he randomly fell asleep. When this occurred, he fell back in his chair and hit his head. He notes blurry vision after this occurred but felt like he was slowly improving. While he was being brought to the ED in a wheelchair he began experiencing blurry vision again and his face became very pale. He was given some apple juice and reports that after 5-10 minutes he felt back to normal. While his vitals were being taken, his HR and BP were very low and he experienced another episode. Pt does not have a hx of passing out 2/2 needles and notes that he gets a flu shot every year and is totally fine. He does note that he became queasy when he tried to give blood in the past but that this does not normally happen. Of note, pt denies any leg swelling prior to these episodes. Pt endorses a low baseline HR in the 50s per his Fitbit but otherwise denies any known heart problems. He notes a fhx of heart problems and states that his dad had heart bypass surgery a couple years ago. Pt denies any daily medications other than vitamin gummies. Denies DVT risk factors or prior history of DVT.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,,,,,,"['Blood cannabinoids normal', 'Blood magnesium normal', 'Electrocardiogram normal', 'Fall', 'Head injury', 'Metabolic function test normal', 'Pallor', 'Syncope', 'Vision blurred']",1,PFIZER\BIONTECH,IM 1050102,CA,51.0,F,"A little over 24 hours after my second dose I started to feel muscle aches, a fever of 102.4, headache, chills, fatigue, diarrhea, sweating, injection site pain, stomach pain and upset. I have been taking Tylenol and Ibuprofen to help with the aches and pains and NyQuil at night to help with fever and aches. It is helpful. I have been eating a BRAT diet and drinking a lot of vitamin water with 0 sugars.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,PVT,Tylenol ibuprofen,,"Fibromyalgia, chronic neck pain, migraines, Osteoarthritis, Sinus congestion",,"Mango, apricot","['Abdominal discomfort', 'Abdominal pain upper', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Myalgia', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1050103,,46.0,F,"HA and sore arm post vaccination immediately. On 2/19 Pt developed chills, low grade fever, fatigue, myalgia, worsening HA, cough, chest tightness. She still has those symptoms. Rapid covid negative so far.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/19/2021,3.0,PVT,,,Lupus,,,"['Chest discomfort', 'Chills', 'Cough', 'Fatigue', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative']",1,MODERNA,IM 1050104,OK,66.0,F,"client says she was in distress prior to taking the vaccine because she had stood for over an hour in line waiting to be seen and she had a double mask on. She says by then she was dehydrated and feeling faint. She has a history of atrial fib off and on, which she takes medication for. She says she feels like she almost had a stroke and Nurse Pract told her she had a full blown panic attack. She was allowed to sit down and rest and rehydrate and eat and she felt better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,OTH,Toprolxl,"hx atrial fib, but no other illnesses",Atrial Fib Hx of 2 different cancers and tx,,Erythromycin causes rash,"['Dehydration', 'Dizziness', 'Panic attack']",1,PFIZER\BIONTECH,IM 1050105,CA,62.0,F,"Symptom first started with soreness in the left tonsil, then swelling and now the pain has moved to my ear canal. This has been going on for 3 days and I have to take Tylenol and provide relief so I can sleep.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/20/2021,11.0,OTH,Metoprolol Rosuvastatin,No,Heart Disease,,No,"['Ear pain', 'Oropharyngeal pain', 'Tonsillar inflammation']",2,MODERNA,SYR 1050107,FL,66.0,F,"After vaccination I experienced very fatigue, nauseous, chills, fever, so cold, and sore, and today 48 hours it appears to have a menstrual cycle or vaginal bleeding that started today, I had a hysterotomy 20 years ago.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/23/2021,2.0,OTH,"Lisinopril, Spiro lactone 25mg, Carvedilol 6.25mg, Aspirin, multivitamin, Vit D4000 and Biotin and took 2 Tylenol after the vaccine",no,Diabetes and HTN,,Betadine and Novocain,"['Chills', 'Fatigue', 'Feeling cold', 'Nausea', 'Pain', 'Pyrexia', 'Vaginal haemorrhage']",2,MODERNA,IM 1050108,MI,59.0,F,"02/13/2021 I developed mild side effects of pain at injection site & minor body aches, These resolved on 02/14/2021. 02/15/2021 I developed an altered sense of smell. I smell an medicinal or chemical smell. Husband does not smell this so it is not an environmental odor. Received a covid test on 02/22/2021 which was negative. The altered sense of smell is still persisting. Notified my doctor of it & she asked that I notify the CDC as it may be a potential side effect from covid vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/15/2021,3.0,PVT,"Levothyroxine, Alendronate, Multi-Vitamin, Calcium supplement, Fish Oil supplement",None,Graves Disease,,"Sulfa drugs, onions","['Anosmia', 'Injection site pain', 'Pain', 'Parosmia', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 1050109,WA,79.0,F,Got the shakes at 11PM on sat. night and at 2Am in the morning i am throwing up. I have a fever my head hurts and my neck. I am still sick. I do not feel good. I am not getting the 2 shot.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/20/2021,5.0,PUB,Losartan/High bloodpressure Atorvastatin Zink-B12 and probiotics,none,none,,,"['Headache', 'Malaise', 'Neck pain', 'Pyrexia', 'Tremor', 'Vomiting']",1,MODERNA,SYR 1050110,MT,89.0,M,"Patient hospitalized after first dose, but before second dose.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/03/2021,02/17/2021,14.0,PUB,,,,,,['Hospitalisation'],UNK,PFIZER\BIONTECH, 1050111,CA,54.0,F,"I had the expected flu-like symptoms for a couple of days, and then on Day 3 got nauseous and started feeling tingling on my face (below the nose and around my mouth. It felt like pins and needles. When it went on for several hours I called Hospital and they advised to contact them if it worsened of I began having symptoms of Bells Palsey or a stroke (not concerning at all!) I took tylenol then ibuprofen and it went away. It's come back two more days (up to today) but has not worsened. Just thought I should report it.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/21/2021,3.0,WRK,Xanax PRN (1/2 of a 25mg tablet) Atrantil supplement Curcumin,none,none,,none,"['Influenza like illness', 'Nausea', 'Paraesthesia', 'Paraesthesia oral']",2,MODERNA,SYR 1050112,OR,37.0,F,"right sided facial swelling, erythema and itching onset 3 days after vaccine, as well as scattered urticaria. feeling of throat tightness. no wheezing.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/23/2021,3.0,PVT,"devenlafaxine, lamotrigine, birth control pills, vit D, naturopathic prescriptions: OC companion, hyper GTF, ashwaganda, triphala",,"sleep apnea, PCOS, obesity, depression",,"tested positive for shrimp allergy on allergy panel, but has never had a reaction","['Erythema', 'Pruritus', 'Swelling face', 'Throat tightness', 'Urticaria']",2,MODERNA,IM 1050113,CA,36.0,M,fevers and chills by 10pm that night with fevers lasting till Sunday. injection site starting to feel itchy on Sunday. Now arm/abdomen/chest has a slight rash.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PVT,,./a,asthma,,"doxy, and z-pack","['Chills', 'Injection site pruritus', 'Pyrexia', 'Rash']",1,PFIZER\BIONTECH,IM 1050114,UT,66.0,F,"Dizzy, weak, feeling faint, tingling tongue and lips, tight jaw",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,OTH,,none,,,,"['Asthenia', 'Dizziness', 'Muscle tightness', 'Paraesthesia oral']",1,MODERNA,IM 1050115,WV,59.0,F,"Shortly after the vaccine I was very fatigued, nauseaed, body aches, bounding HR and a headache but no where as severe as before but GI cramping was associated this time and I also had a 104 fever but the fatigue and bounding HR lasted longer this time",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/05/2021,0.0,OTH,"Sintyroid, Losartan, 325 mg aspirin, metroprol, Vit D., fish oil, protonics",AE to the first vaccine,"Stents in the Heart, Fibroids, Tyroid issues. IBS, Fibromyalgia, Hypertension, Diabetic-Controlled, sleep apnea",1/2021-Moderna COVID019,"IVP dyes, Amoxicillin, Zanaflex, Bactruim, Viaxin, Cinnamon, Raisin, Cypro","['Body temperature increased', 'Fatigue', 'Gastrointestinal pain', 'Headache', 'Nausea', 'Pain', 'Pulse abnormal', 'Pyrexia', 'Vaccine positive rechallenge']",2,MODERNA,IM 1050116,RI,55.0,F,"55 yr old arrived to medical room escorted by employee, pt was a/ox4 and c/o of tingling in tongue and lower lip. Pt had received her 2 dose of the moderna vaccine in her RT arm. Pt was brought into the medical room and sat on stretcher. Pt vs were taken and bp was 166/95, hr was 73, resp 18, spo2 was 97% ra. Pt rested in room for 15 mins and her last set of vs improved. Bp was 143/99, resp 18, hr was 72, spo2 was 96% ra. Pt felt better and signed a refusal to be transported to er. Pt was released by provider to observation area and pt checked out.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,UNK,"Lisinopril, hctz, atorvastatin, xanax",No illness,"Htn, hcl, anxiety",,Sulfa,"['Blood pressure abnormal', 'Paraesthesia oral']",2,MODERNA,IM 1050117,OR,58.0,F,"began having itching inside ears and tongue, without tongue swelling; intermit cough within about 5 minutes after administered. Pt took 25mg of personal benadryl. Pt continually monitored for 30 minutes following benadryl administration. Cough resolved after 10 minutes, other symptoms remain unchanged. 25 minutes following benadryl, patient stated symptoms resolved. Pt monitored another 5 minutes, vital signs rechecked. Pt sent home with spouse in stable condition.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,OTH,,,,,polyethelene glycol,"['Cough', 'Ear pruritus', 'Tongue pruritus']",2,PFIZER\BIONTECH,IM 1050118,VA,75.0,F,"chills' nausea, fatigue weakness still not back to myself after10 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/14/2021,1.0,PVT,"metformin .,hydrochlorothiazide, lisinopril ,pantoprazole ,fish oil ,baby aspirin",no,"diabetes, high blood pressure",,"codeine, sulfa","['Asthenia', 'Chills', 'Fatigue', 'Nausea']",2,MODERNA,SYR 1050119,,32.0,M,"Began - General weakness, body aches, chills 12 hours later - 102 fever, full body/joint aches, chills 24 hours later - above continued 40 hours later - symptoms subsided fever came down below 100 minimal aches, etc 48 hours later - 102 fever, no body ache, chest/throat tightness (trouble deep breath), chills (considered urgent care) 64hours later - temp consistently normal bouts of chest tightness occasionally (believe fully recovered) Began regiment of Tylenol (500mg) every 4-6 hours (as close to 6 as possible) w inbuprphin (200mg) as needed (occasionally instead of Tylenol). Neither medication worked for all symptoms (Tylenol better for fever and chest tightness ibuprophin better for body aches)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/21/2021,20.0,PVT,None,None,None,,None,"['Asthenia', 'Chest discomfort', 'Chills', 'Dyspnoea', 'Pain', 'Pyrexia', 'Throat tightness']",2,PFIZER\BIONTECH,SYR 1050120,WY,73.0,M,"Client developed Bell's Palsy on right side of face approximately 2 weeks after receiving vaccine. Client reports his PCP is treating with steroids, which has helped.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/14/2021,16.0,PUB,,None,,,None,"[""Bell's palsy""]",1,MODERNA,IM 1050121,TX,64.0,F,"COVID arm. Large red, hot and raised around injection site. It?s been 2 1/2 weeks and there is still a rash although it?s not red and hot anymore.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/08/2021,0.0,OTH,Tamoxifen Multivitamin Vitamin D 3 Trazodone 50 mg,,Breast cancer in 2019,,,"['Injection site erythema', 'Injection site rash', 'Injection site warmth']",1,MODERNA,SYR 1050122,CA,,U,"4:20 pm 3 hours after vaccine: tingling in throat. Took 10 mg. Zyrtec - resolved in 40 min. Next a.m. 2:30: awoke with tight band of pressure and deep ache around diaphragm and lung bases. Difficult to get full breath. For next 11 days, I was air hungry and unable to take a deep breath?but not during exercise. Awoke on day 12....and air hunger was gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,OTH,,,,,,"['Chest discomfort', 'Diaphragmalgia', 'Dyspnoea', 'Pharyngeal paraesthesia']",1,MODERNA,IM 1050123,MN,74.0,M,"Suffered severe dizziness beginning 56 hours after receiving 2nd shot. The dizziness last approximately 2 hours and the light-headed feeling continued for an additional 12 hours. All symptoms ceased by 7:00 am Feb 22, 2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/20/2021,2.0,PVT,"Lisinopril, simvastatin, adult multi-vitamin, supplements C, D",none,none,,none,"['Blood test', 'Dizziness', 'Physical examination']",2,PFIZER\BIONTECH,SYR 1050124,CA,30.0,F,"1st Covid vaccine on 2/19/2021, patient had syncope in the parking lot, unbale to speak, confused taken to the hospital by ambulance.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/19/2021,0.0,PVT,none,none,DM 1,,none,"['Aphasia', 'Blood test', 'Computerised tomogram head', 'Confusional state', 'Syncope']",1,MODERNA,IM 1050125,MT,41.0,F,"Reported to vaccinating pharmacist by patient via phone on 2/23/2021 of dizziness shortly after the vaccine that lasted intermittently x 3 weeks, felt like had a fever (temperature not checked) x 3 weeks, swelling of face about 2 weeks after vaccine which was also directly after a massage (had botox ""not long ago in the past""), swelling of the lymph glands, headaches and migraines started. Went to the hospital on 2/19/2021 via ambulance due to migraine. At the hospital patient was treated with anti-emetic, fentanyl, and other unknown medications that included benadryl. Was discharged same day. Continued to have a migraine next two days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,OTH,"flexeril, norco, amoxicillin, Imitrex",flu-like viral illness of unknown cause 2 weeks prior to vaccine,thyroid cancer,,None,"['Dizziness', 'Headache', 'Lymphadenopathy', 'Migraine', 'Pyrexia', 'Swelling face']",1,MODERNA,IM 1050126,IL,31.0,M,"1145 vaccine administered 1147 patient stood up from chair and then had syncopal episode. Fell face first onto floor. Hit head on wall trim on the floor. Eyes dilated, fists clinched, arms and legs shaking , not responding to verbal cues. Seizure like activity last approximately 1.5 minutes 1150 called 911 1200 ambulance arrived on scene. patient c/o lightheadedness and needing to continue to lay down 1210 transported patient to ER at Hospital",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PUB,,,Reactive hypoglycemia,,NKA,"['Dizziness', 'Face injury', 'Fall', 'Head injury', 'Muscle tightness', 'Mydriasis', 'Seizure like phenomena', 'Syncope', 'Tremor']",1,PFIZER\BIONTECH,IM 1050127,CA,42.0,M,"Immediate reaction - ""not feeling well"", dizzy to the point that he was not safe to walk Blood pressure had been a little above normal prior to vaccination and remained high during the half hour of observation, but had started to come down a few points by the time he was taken in a wheelchair to family to go home and rest.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,PVT,,,,,,"['Dizziness', 'Hypertension', 'Immediate post-injection reaction', 'Malaise']",2,MODERNA,IM 1050128,WV,70.0,M,"02/07/21 through 2/13/21 slightly fatiqued, took all his prescribed medications, ate breakfast, lunch and dinner was drinking eight 10 oz bottles of water. On 02/14/21 was very tired had a difficult time breathing after taking the normal meds. He took a breathing treatment with his prescribed Ipratropium Bromide and Albuterol Sulfate via home nebulizer. This did not improve his breathing. He was very weak and breathing was labored. 911 was called by wife. 911EMTchecked pulse and breathing. Informed him they would give him a breathing treatment.He started to go limp. EMT's got him to Ambulance and to Medical Center to the ER. Heroics done. He died. Pulmonary and Cardiac Arrest",Yes,02/14/2014,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/07/2021,1.0,PUB,"Eliquis 5MG, Carvedilol 6.25MG, Ramipril 2.5 MG, Atorvastatin 80 MG 1 tab daily ,Stiolto Respimat Inhalation spray 2 puffs per day; Albuterol Sulfate Inhaler as needed, Ipratropium Bromide 0.5 mg and Albertol Sulfate0.3mg inhalation soluti",none,1.COPD started in 2008 from a Neurosurgery and had to be on a ventalator: 2 Open Heart Surgery Had a pacemaker,,Penicillin,"['Asthenia', 'Cardiac arrest', 'Death', 'Dyspnoea', 'Fatigue', 'Gait disturbance', 'Loss of consciousness', 'Respiratory arrest']",UNK,PFIZER\BIONTECH,IM 1050130,GA,79.0,F,"Woke up Sunday morning 02/21/2021 with cold chills, quickly turning to hot flashes, continuing with a severe headache,vomiting,diarrhea ,and nausea. Continuing thru Monday 02/22/2021 and Tuesday 02/23/2021. Called my Dr?s office at 9:00;AM 02/23/2021. Have not heard back. There message recording asks not to duplicate calls, which I did not do.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,PVT,Levothyroxin 100MCG Vitamin D3 2000 IU Pantoprazole SOD 40 MG Vitamin B 12 2500 mcg Atorvastatin 40 MG Magnesium 500 mg AMlodipine 5 MG,None,None,,Codeine,"['Chills', 'Diarrhoea', 'Headache', 'Hot flush', 'Nasopharyngitis', 'Nausea', 'Vomiting']",2,MODERNA,SYR 1050131,TX,38.0,M,"Over 3-4 days had the expected flu-like symptoms (headache, fever, body ache, chills, etc.). On the second day had intense pain in base of lungs that would intensify in waves alongside elevated heart rate (just under 100bpm, measured oxygen level was still 98%). The pain lasted about 4-6 hours and then subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/10/2021,1.0,UNK,"Advair, Allegra, Nasonex",None,"Asthma, environmental allergies",Skin rash to preservative version of flu vaccine. No reaction to preservative free version.,Sulfa,"['Chills', 'Headache', 'Heart rate increased', 'Influenza like illness', 'Pain', 'Pulmonary pain', 'Pyrexia']",2,PFIZER\BIONTECH,SYR 1050132,MN,52.0,M,"> 48 hours of intractable hiccups 5 days of fever, peaking at 102.6 F Debilitating headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/03/2021,0.0,OTH,Ibuprofin & Amoxicillin for recent dental surgery,None,High blood pressure (142/96),,None,"['Chest X-ray normal', 'Headache', 'Hiccups', 'Pyrexia', 'SARS-CoV-2 test']",1,MODERNA,IM 1050133,CA,74.0,F,13 hours after injection I developed fever or chills bodyaches and fatigue which lasted until the next morning. Then all reactions were completely gone and I was back to normal,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PVT,HRT,Na,Na,,Na,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",2,MODERNA,SYR 1050134,CO,45.0,F,"Nausea, vertigo, ataxia, falls, change in vision persisting currently",Not Reported,,Not Reported,Not Reported,,Yes,N,01/16/2021,01/23/2021,7.0,PVT,,,,,,"['Ataxia', 'Fall', 'Laboratory test', 'Magnetic resonance imaging', 'Nausea', 'Vertigo', 'Visual impairment']",2,PFIZER\BIONTECH,IM 1050135,MA,67.0,M,Patient fainted when walking to bathroom after observation.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/23/2021,02/23/2021,0.0,OTH,,,,,,['Syncope'],UNK,PFIZER\BIONTECH,IM 1050136,CO,65.0,F,"Large red blotch has developed on arm where shot was given, appearing about a week after the shot, itchy and about 2.5"" in diameter. Has looked this way for 4 days now.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/14/2021,02/21/2021,7.0,PHM,Atorvastatin 10mg day Alendronate Sodium 70mg / once per week (generic Fosamax) Also: multivitamin,None,None,,None,"['Injection site erythema', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,SYR 1050137,LA,89.0,M,"Pt received second Moderna Vaccination on 2/21/21 at 1:00 pm at Pharmacy. Pt present on 2/22/21 to ER via ambulance at 1940. Upon presentation C/C hypotension Post COVID vaccine. Nurse notes states that Home Health nurse sent patient to ER secondary to hypotension and hyperglycemia. Pt states back ached and was holding his head. Nurse noted pt had random petechiae over body and bruising to abdomen following injections received during recent hospitalization. (unknown hospitalization). Patient was treated with IVF bolus in addition to initiating Dopamine for hypotension, patient became agonal and daughter at bedside presented Adv. Directive, pt was DNR. Pt pronounced time of death was 2110pm. (Pt only reported a sore shoulder secondary to vaccine).",Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/22/2021,1.0,PHM,"Entresto, Metoprolol, Spironolactone, Vit D, Lasix, Flomax, Digoxin, Eliquis, Tradjenta, ASA, Novolog Flex pen, Levothyroxine, Vit B12, Lipitor, Aricept, Temazepam, Lorazepam, Glucose prn.",Fall on 2/15/21 pm resulting in skin tear requiring dressing. Pt Seen on 2/16 for skin tear repair secondary to fall the pm prior. Vital signs WNL. Pt returned on 2/20/21 for dressing change. Vital signs WNL. Pt received second Moderna Vaccination on 2/21/21 at 1:00 pm at Pharmacy. Pt present on 2/22/21 to ER via ambulance at 1940. Upon presentation C/C hypotension Post COVID vaccine. Nurse notes Home Health nurse sent secondary to hypotension and hyperglycemia. Pt states back ached and was holding his head. Nurse noted pt had random petechiae over body and bruising to abdomen following injections received during recent hospitalization. (unknown hospitalization),"Hypertension, MI, CHF, DM, CRF, Thyroid, High Cholesterol, Prostate",,"Shrimp, Red Man Syndrome, Cleocin, Clindamycin","['Agonal death struggle', 'Back pain', 'Blood chloride decreased', 'Blood creatinine increased', 'Blood glucose increased', 'Blood lactic acid', 'Blood potassium increased', 'Blood sodium normal', 'Blood urea increased', 'Brain natriuretic peptide increased', 'C-reactive protein increased', 'C-reactive protein normal', 'Chest X-ray abnormal', 'Contusion', 'Death', 'Electrocardiogram', 'Electrocardiogram abnormal', 'Haematocrit increased', 'Haemoglobin increased', 'Headache', 'Hyperglycaemia', 'Hypotension', 'Lung opacity', 'Pacemaker generated rhythm', 'Petechiae', 'Troponin', 'White blood cell count increased']",2,MODERNA,IM 1050138,CA,38.0,F,"7 days after receiving the vaccine, I developed intense, deep muscle pain and swelling. The arm where I received the vaccine was very hot to the touch. The next day, I had chills and a mild fever, along with swollen and sore arm. Through the weekend, I developed redness in splotches that were similar to hives in appearance. My arm has been intensely itchy. On Saturday, 2.20.21, the lymph node under my left arm became very swollen and painful. I am currently still experiencing a mildly sore arm (pain has lessened since yesterday), arm is still very hot to the touch, still have red rash/hives and my lymph node is still very painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/18/2021,7.0,PVT,Levothyroxine Nora B,,Hypothyroid,,,"['Chills', 'Lymph node pain', 'Muscle swelling', 'Myalgia', 'Oedema peripheral', 'Pain in extremity', 'Peripheral swelling', 'Pruritus', 'Pyrexia', 'Skin warm', 'Urticaria']",1,MODERNA,SYR 1050139,NY,34.0,M,"Heaviness in my chest, sensation of not getting a full breath, extreme lack of energy and exhaustion",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/16/2021,12.0,OTH,Pantoprazole Singular Propecia Echinacea,N/a,Asthma Gerd,,N/a,"['Asthenia', 'Chest discomfort', 'Dyspnoea', 'Fatigue']",2,MODERNA,IM 1050140,WA,41.0,F,"Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The following day she noted a low-grade fever. On January 26 she noted edema of her eyes and lips associated with facial redness and itching that she treated with Benadryl intermittently for the past 2.5 weeks. She was seen in follow-up by her dermatologist who suspected an inflammatory reaction and prescribed anti-itch facial cream. She was also seen by her primary care who suspected angioedema and prescribed her an EpiPen which she has not needed to use. Pfizer shot #2: 2nd shot delayed due to snow. Above sx resolved before shot #2. She had her 2nd COVID injection February 20 at 3:50 p.m. About 1.5-2 hours later she noted onset of itching to her eyes and nipples along with itching of the skin in the locations of her usual eczema. She noted that her lips and eyes were a little puffy but less severe swelling to the eyes and lips than the 1st injection. She took 2 Benadryl shortly after onset of these symptoms. This seemed to lessen symptoms about 50%. Later she noticed that her voice sounded raspy and hoarse and she had a sensation of swelling to her tongue and throat but she was able to swallow. Her throat felt scratchy. She denies having lightheadedness, urticaria or GI symptoms. She went to the ED and was treated with benadryl, solumedrol and pepcid, monitored for a few hours and then discharged on 60 mg prednisone X 3 days and advised to continue benadryl 50 mg Q6h. She takes zyrtec 10 mg BID for seasonal/perennial allergies. Allergy history: She has a history of both idiopathic urticaria in early childhood and idiopathic angioedema in her early 20's. States she had extensive testing but the cause was never exposed. Took high dose prednisone for 4-5 months, angioedema resolved spontaneously and then flared again a few months later. Finally resolved with n additional 3 months of prednisone. She has both seasonal (feb-may) and perennial allergies to cat and dust, asthma and allergy to ampicillin--rash in childhood, and humira--fevers.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,UNK,"CYMBALTA, 20 mg, PO, BID diphenhydrAMINE 50 mg oral capsule, 50 mg= 1 cap(s), PO, QID hydrOXYzine hydrochloride 10 mg oral tablet, 20 mg= 2 tab(s), PO, QID, PRN metoprolol succinate, PO, Daily predniSONE 20 mg oral tablet, 60 mg= 3 tab(",ADD (attention deficit disorder) Allergic reaction to COVID-19 vaccine Depression GERD (gastroesophageal reflux disease) Rheumatoid arthritis,ADD (attention deficit disorder) Allergic reaction to COVID-19 vaccine Depression GERD (gastroesophageal reflux disease) Rheumatoid arthritis,,"Humira, amoxicillin","['Cheilitis', 'Dysphonia', 'Erythema', 'Eye oedema', 'Eye pruritus', 'Lip oedema', 'Paraesthesia oral', 'Periorbital swelling', 'Pruritus', 'Pyrexia', 'Tryptase']",2,PFIZER\BIONTECH,SYR 1050141,PA,63.0,F,"Fever, all joints ached, fatigue, headache, shivering",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,WRK,Levothyroxine,None,None,,Sulfa,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Pyrexia']",UNK,MODERNA, 1050142,CA,42.0,F,"Paralysis for 2 days. Unable to use either arm, barely able to bear weight or walk. Had to be fed, given water, and helped to go to the bathroom.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/16/2021,1.0,PVT,,,,,,"['Gait disturbance', 'Limb immobilisation', 'Loss of personal independence in daily activities', 'Paralysis', 'Weight bearing difficulty']",1,MODERNA,IM 1050143,MA,87.0,M,"Rash at the injection site almost down to elbow and around to the underside of the arm with extreme itching. Started 5 days after injection at initial injection site, was as big as tennis ball and has increased substantially every day since. Used cortisone to subdue itching but went to pcp Dr to examine the site. She prescribed cetirizine and cephalexin for 5 days. Itching has stopped but rash is still large and present. Will revisit with Dr on 2/25/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/15/2021,5.0,OTH,"Warfarin, D3, B6, B12, saw palmetto, red yeast rice, turmeric, miralax",None,Atrial fibrillation Have a pacemaker,,Allergic to eliquis- itching,"['Injection site mass', 'Injection site pruritus', 'Injection site rash']",1,MODERNA,IM 1050144,MD,65.0,F,"First vaccine on 1/30, 10 days later started with a few hives. Thought it was new medication, took benadryl but lasted on and off for 10 days. Didn't think it was related to the vaccine. On 2/18 had more severe hives called my dr. She didn't see a reason not to get the second vaccine. 2 vaccine on 2/20 at 1:15. Sunday around 9:00 the hives started again. By 2:00 am it was severe, took benadryl everyd 4 hours after a few hours of sleep decided to go to the ED. Hive were severe from ankles to collar bone. very itchy. Was given epi injection and iv solumedrol and pepcid. Stopped itching and was discharge with prescriptions for Prednisone and pepcid. No more hives or itching at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PUB,Gabapentin Synthroid Xarelto Celexa lipitor losartan onglyza,none,"Diabetes type2, obesity, hypothyroidism, htn, chronic kidney disease Stage 3, neuropathy, osteoporsis",,"dilaudid, ace inhibitors, sulfa, ceftin, zanaflex","['Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,IM 1050145,CA,89.0,F,"rt arm swollen, neck pain, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,PVT,"xarelto 15mg, spironolactone 25mg, dilitazam 240mg, azopt, lumigan, tylenol",,arthritis,,"yeast, dairy, ephedrine, codeine, corticosteroids, Levaquin, metoprolol, lisinopril, tramadol,","['Headache', 'Neck pain', 'Peripheral swelling']",2,MODERNA,IM 1050146,CA,58.0,F,"Chills, weak, headache started on 2/7/21 (day3) unable to work from 2/8/21 through 2/12/21. Teleheath visit with PCP on 2/9/21. Symptoms resolved by 2/12/21. Self care with meds (allergy and pain meds) rest, fluids.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/07/2021,2.0,PVT,,,,,,"['Asthenia', 'Chills', 'Headache']",2,MODERNA,IM 1050147,IN,48.0,F,"The day of the injection, approx. 3-4 minutes after getting the injection, I almost passed out. I became hot, sweaty, dizzy and my head starting to buzz. The nurse on-site provided me a couple cold packs and after about 30 minutes, I felt better. The nurse described my response as a ""vascular"" reaction. Later that night, I got a headache and night sweats and bouts of nausea. They only lasted a day. Approx. 10 days after the injection, the injection site became red, swollen, itchy and uncomfortable to the touch. Then it traveled down my arm and created a large red, swollen, itchy area on my entire upper arm. I advised my doctor and she provided me a Rx for a topical steroid and oral steroid. After 5 days of treatment, it is 90% better. The injection site still hurts.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/16/2021,10.0,OTH,Allegra - 1x/day; Bijuva 1/100 daily; Daily Vitamin,None,None,Injection site pain and skin reaction when getting a tetanus vaccine,Sulfa drugs,"['Dizziness', 'Feeling hot', 'Headache', 'Hyperhidrosis', 'Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Nausea', 'Night sweats', 'Presyncope', 'Tinnitus']",1,MODERNA,IM 1050149,CA,61.0,F,"Right side upper arm ache spread to right side of neck and into headache at back and top of skull. Persisted through night and spread down into right side of neck to left arm ache. Throat became red and right, then left side of tonsil became pus filled. Chills but no fever. Fatigue every day. Took 2-3 hour naps every couple of days and slept 8-10 hours through the nights. Headache off and on for 10 days. Throat remained red, becoming most sore late afternoons, voice hoarse. On and off drippy nose. On the 13th day I felt normal energy level in the morning but today, my 15th day at nearly 3pm, my normal energy is waning and throat becoming sore again.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/09/2021,0.0,OTH,Replens vaginal moisturizer,,,,penicillin,"['Asthenia', 'Chills', 'Dysphonia', 'Headache', 'Neck pain', 'Oropharyngeal pain', 'Pain in extremity', 'Pain of skin', 'Pharyngeal erythema', 'Pharyngitis', 'Upper-airway cough syndrome']",1,PFIZER\BIONTECH,SYR 1050150,CA,74.0,F,"PATIENT REPORTED ON DAY #4 POST-VACCINE THAT HER NECK AND CHEST VEINS WERE PROMINENT BILATERALLY, MORE SO ON SIDE OF VACCINE SITE (RIGHT). HAD AUDIO TELEHEALTH APPOINTMENT WITH PROVIDER ON POST-VACCINE DAY #3, 02/22/2021. DID NOT BECOME AWARE OF SYMPTOM UNTIL AFTER APPOINTMENT HAD CONCLUDED. ALSO REPORTED THAT INITIALLY HAD LOCALIZED REDNESS, RED STREAK, SWELLING AND ITCHING AT VACCINE SITE, BUT THAT THOSE SYMPTOMS WERE NOW RESOLVING. ADVISED EVALUATION BY PROVIDER, REPORTING TO CDC's V-SAFE, AND SEEKING URGENT/EMERGENT CARE IF NEEDED.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/01/2021,,PVT,,,,,LEVAQUIN TABS,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",1,MODERNA,IM 1050151,UT,72.0,F,"Received COVID vaccine 2/10, the morning of 2/11 woke up with stiff neck, continue to get worse, on 2/14 neck muscles started spasming around 11am, was unable to move, had to have friend take her to the emergency room around 3 pm,. The spasms continued for 11 1/2 hrs, and stiffness gradually resolved over the next 3 days, was given muscle relaxant and ibuprofen. She has discussed this with her PCP, he encouraged her to get 2nd vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/11/2021,1.0,PUB,,,,,,"['Mobility decreased', 'Muscle spasms', 'Musculoskeletal stiffness']",1,MODERNA,IM 1050152,WA,66.0,F,"She received her 2nd shot on 2/20/2021. Within minutes she noticed that she could not see, due to localized swelling around her eyes. She began to feel itchy and her tongue felt swollen. She was taken to ED and was given Benadryl and Solu-Medrol, her symptoms continued and she was administered epinephrine about an hour later which immediately cleared up her symptoms. She has some residual generalized itching and has been taking Benadryl 50 mg every 6 hours until 9:00 p.m. yesterday. She also takes Zyrtec 10 mg daily starting yesterday. She denies having any dizziness or lightheadedness, hives urticaria, nasal congestion, weepy eyes, diarrhea or abdominal cramping. She does endorse nausea and was administered Phenergan in the emergency department. She also endorses that her eyes felt itchy. She also endorses that she was able to swallow. Takes celebrex but paused this prior to the vaccine to prevent possible anti-inflammatory interrupting vaccine efficacy. Her ED record is available for review. Exam findings endorse she is tolerating secretions, speaking in full sentences and her tongue was not enlarge. No labs were drawn during her visit. She denies historical reactions to vaccines. She does get itching with some medications. Historical angioedema/urticaria post pistachio and bran muffin were singular events and have not recurred. She had a normal tryptase in 2014",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,WRK,"albuterol CFC free 90 mcg/inh inhalation aerosol, 2 puff(s), ORAL INH, QID, PRN, 3 refills BENADRYL, 25 mg to 50 mg, PO, Q4 Hours, PRN budesonide 0.5 mg/2 mL inhalation suspension, See Instructions, 3 refills budesonide-formoterol 80 mcg","chronic rhinitis, URI with sequalae Oct '20, mild intermittent asthma","4th nerve palsy Comments: of left eye dx dr Acute sinusitis Adjustment disorder Anemia Angio-edema-urticaria Asthma, mild intermittent Balance problem Biceps tendon rupture Cervical arthritis Chronic cough Cognitive decline Discomfort Dystonia Comments: left forearm/hand Elbow fracture, left Comments: elbow dislocated/fx with surgical repair 1986 and 2011 Encounter for annual general medical examination with abnormal findings in adult GERD (gastroesophageal reflux disease) Helicobacter pylori (H. pylori) Hernia, ventral Comments: left upper abdomen Hypothyroidism NOS Inflamed seborrheic keratosis Menopausal syndrome Menopause Mild persistent asthma Muscle weakness of right upper extremity Osteoarthritis of lumbar spine Pernicious anemia Pertussis-like syndrome RAD (reactive airway disease) Renal artery stenosis Right shoulder pain RLS (restless legs syndrome) Rosacea Sinusitis Comments: surgery Stiffness of right shoulder joint Thyroid nodule Urine incontinence",,"ondansetron (unknown) Desipramine Hydrochloride (Flushing or Hives) Flagyl (Flushing or Hives) NSAIDs (GASTRITIS AND DUODENITIS) Vicodin (PRURITUS AND RELATED CONDITIONS, PRURITUS AND RELATED CONDITIONS)","['Eye pruritus', 'Nausea', 'Periorbital swelling', 'Pruritus', 'Swollen tongue']",2,PFIZER\BIONTECH,SYR 1050153,WI,63.0,F,"At 11am on 2/16, my arm began to get sore. I took Advil at 4pm and it wasn't so bad. At about 10pm when I went to bed, I had issues falling asleep because my heart felt like it was pounding through my chest. That pounding came off and on during the next day. I woke up twice and my feet were ice cold and my body was very hot. The second time I woke I thought I would take some tylenol and was extremely dizzy walking to the bathroom. I was so weak I couldn't open the bottle. I slept nine hours, very unusual. I felt very under the weather all day until around 5pm. I woke up the next morning feeling pretty normal. The arm pain was completely gone by the 18th.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,WRK,"Multi-vitamin with mineral, vitamin D with K, krill oil, potassium, calcium, berberine",none,none,,none,"['Asthenia', 'Dizziness', 'Feeling hot', 'Malaise', 'Pain in extremity', 'Palpitations', 'Peripheral coldness']",2,MODERNA,SYR 1050154,AZ,77.0,M,Pulmonary Embolism right lung and blood clot in right leg. No travel or other events or activities are known that might have contributed to blood clots in leg and lung. Symtoms of embolism first appeared about 10 days following 2nd dose of Pfizer vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/13/2021,10.0,PVT,"Zocor, Flomax",None,None,,None,"['Blood test abnormal', 'Computerised tomogram abnormal', 'Deep vein thrombosis', 'Pulmonary embolism', 'Ultrasound Doppler abnormal', 'X-ray abnormal']",UNK,PFIZER\BIONTECH, 1050155,AK,68.0,F,"Feb 8,2021 wokeup around 6am and noticed slightpain and small area of redness around area on left arm I had covid-19 injection Jan 30,2021. It was there daily , appeared hot and the reddened area appeared to widen. The area was more itchy than painful. I looked for similar symptoms/side effects on the internet and found photos of ""covid arm"" that resembled mine. I eventually applied some topoical benadryl around the 15 February which by this time was looking better-less redness and area. Back to normal by February 16th.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,02/08/2021,9.0,PHM,Dorzolamide HCL 2% eye drops Losartan Potassium 100mg tab Chlorthalidone 25mg tablet,none that I am aware of,obesity osteoarthritis high blood pressure,"swelling at vaccine site -5 or 6 years ofage, not sure ofvaccine type and brandname-, No adverse effects since except for this l","several eye drops, Quinolones","['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site warmth']",UNK,MODERNA, 1050156,FL,57.0,F,"Nausea, diarrhea, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/23/2021,6.0,PVT,Rinvoq,None,Rheumatoid arthritis,,No,"['Diarrhoea', 'Headache', 'Nausea']",1,PFIZER\BIONTECH,SYR 1050157,CA,43.0,F,Swelling of the lips- angioedema,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/22/2021,1.0,PUB,"Multi-vitamins, turmeric, collagen, biotin",None,Mitral-valve prolapse,,None,"['Angioedema', 'Lip swelling']",1,PFIZER\BIONTECH, 1050158,CA,83.0,M,"Resident is a Hospice patient. On 1-23-2021 am shift resident was observed by nursing have chest congestion and had a emesis times 1 with SOB, Zofran 4 mg was given. HOB (02 sats 88%) was elevated resident on 02 via nasal canula with 02 sat now @ 90% . no respiratory distress noted. MD was called with response pending for orders. @ 1400 resident with no signs of life. vs 90%-24-97/71-97.6. Hospice on site and time of death 1436",Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/23/2021,26.0,SEN,"Tramadol HCI tab 50mg po Qday, Ambien titrate 5 mg PO QHS PRN, Promethazine DM Syrup 6.25-15mg/5ml give 5ml Q4hrs prn, Zofran 4mg 1 tab PO Q 4 hours PRN, Morphine sulfate 15mg give 0.5mg PO Q 4hours PRN , Bowel care","Dementia, History of CVA affecting left side, history of COVID 19 in December 2020, Aphasia.","Dementia, History of CVA affecting left side, history of COVID 19 in December 2020, Aphasia.",,No known allergies,"['Death', 'Dyspnoea', 'Pulmonary congestion', 'Respiratory tract congestion', 'Vomiting']",1,PFIZER\BIONTECH,IM 1050159,KY,36.0,F,"Red rash appeared 7 days post vaccination, has continued for 5 days so far. Rash has grown in size from about 1/2 inch to 4 or more inches in diameter. large, warm and flat rash on upper left arm at injection site. Rash has spread to underside of upper arm and unto forearm but appears ""lacey"" and is raised. Mild itchy. Swollen lymph node notice on 2/23/21 in left armpit. This is 11 days post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/19/2021,7.0,PUB,labetalol junel colestid B-12 Lexapro omeprazole,,hypertension sleep apnea,,azithromycin hygroton,"['Injection site erythema', 'Injection site lymphadenopathy', 'Injection site rash', 'Injection site warmth']",1,MODERNA,SYR 1050160,CA,76.0,F,"Apparent COVID Arm: Large red blotchy patch (3 inches in diameter) at the site of the injection that appeared approximately 9 days after first dose shot. Extremely itchy!! Applied cortisone ointment to the area 2-3 times a day for approximately 3 days. Saw personal physician on 2/16/21 to discuss my reaction and to confirm that there was no need for concern and it would be safe to receive my second dose. As of this reporting, my arm has cleared up completely and I am no longer experiencing any itch or pain. At the time of the injection, I experienced pain as the vaccine was being administered and subsequently a very painful arm for approximately a week and a half.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/09/2021,8.0,PHM,"Trimethoprim, Atenolol, Crestor, Imvexxy Eye Science Macular Health Vitamin, CoQ10, Omega-3, Viactiv Calcium Chew, B12 2000, Phillips Probioyic, Liquid Vitamin D3 with K2, low dose aspirin, stool softener, Beta Plus",None,Pre-diabetes,,Sulfa,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus']",1,MODERNA,SYR 1050161,AL,91.0,F,stomach pain and other common symptoms were completely gone by the morning of 2/17/21,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,PUB,"albutererol sulfate inhalation solution 2.5mg every 4 hrs, advair 500/50 , Spiriva Respimat,",,"RA , COPD",,none known,['Abdominal pain upper'],2,MODERNA,IM 1050162,CA,68.0,F,Felt severely depressed for at least 5 hours --completely resolved when she awoke the next morning.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,UNK,"Keppra, levothyroxine, omega 3 fish oils, Vitamin C, Vitamin D, Magnesium, Multivitamin, Calcium",,"h/o epilepsy and hypothyroidism, h/o hepatitis A and B",,"Amoxicillin/Penicillin (tachycardia), ibuprofen (tachycardia)",['Depressed mood'],UNK,MODERNA,IM 1050163,CA,65.0,M,Rash around the injection area,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/29/2021,6.0,UNK,"Advil, claritan",,Asthma,,Penicillin,['Injection site rash'],1,MODERNA,SYR 1050164,AZ,71.0,M,"Rash, swelling, soreness , itch at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/22/2021,9.0,PHM,"Trazodone, Losaran , levothyroxine, metformin,",None,"High blood pressure, sleep apnea, asthma, insulin resistance",,Penicillin,"['Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Rash']",UNK,MODERNA, 1050165,CO,52.0,F,"Stiff neck, neck pain 8/10 with looking side to side and up. Sometimes goes down center of cervical spine when looking up. No swelling/redness. History of neck pain but nothing like this or this long.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/11/2021,2.0,PVT,"Sumatriptan, topiramate",None,"Migraine, GERD",,NKDA,"['Musculoskeletal stiffness', 'Neck pain', 'X-ray']",2,MODERNA,IM 1050166,IN,30.0,M,"Patient experienced light headedness and symptoms consistent with syncope, as well as nausea. the syncope event occurred in the chair without a fall. per patient reporting patient had not eaten 8 hours prior to administration time and also experienced anxiety with vaccines. patient was given supportive care including assisting to the floor carefully with a pillow provided and feet elevated. patient was also provided with juice to support any potential low blood sugar.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PHM,,,,,,"['Anxiety', 'Dizziness', 'Nausea', 'Syncope']",1,PFIZER\BIONTECH,IM 1050167,WA,47.0,F,"Initially I had soreness,swelling and redness in my left arm. after about four days soreness disappears but the swelling still there and circumferential red blotch with itching persist",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/13/2021,1.0,OTH,"amlodipine,lipitor,aspirin",none,hypertension,,none,"['Limb discomfort', 'Peripheral swelling', 'Pruritus', 'Rash macular']",1,MODERNA,IM 1050168,NY,23.0,F,"Fever, achiness, nausea, and then vomiting 5 times, unrelated to food. Most of it was bile. At 12:30 AM Feb 21 I woke up with violent chills and took an tylenol to break the fever. At 3:00AM I threw up for the first time, then again at 5:00AM, then again at 6AM, 7AM, and the last one was at 7:30AM.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,OTH,"omeprazole, cranberry supplements",,GERD,,,"['Chills', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,MODERNA,SYR 1050169,TX,68.0,F,Diamond shape red skin belowinjection shape,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/28/2021,7.0,PHM,"Amlodipine Besylate/valsartan,Atorvastatin calcium Nitrofurantain,lioyhyronine , Amitropyline",none,"high blood pressure and cholesterol,hypothyroid",,penicillin,['Injection site erythema'],1,MODERNA,IM 1050170,,29.0,M,"Headache, arm soreness and muscle pain, chest tightness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,MIL,None,None,None,,None,"['Chest discomfort', 'Headache', 'Myalgia', 'Pain in extremity']",1,MODERNA,SYR 1050171,OR,50.0,F,"Nausea, Vomiting, SOB, Palpitations, Fatigue, Headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,unknown,None reported,None reported,,none reported,"['Dyspnoea', 'Fatigue', 'Headache', 'Nausea', 'Palpitations', 'Vomiting']",2,MODERNA,IM 1050172,WA,96.0,F,"Individual developed severe body aches, severe shoulder discomfort, high fevers (documented max temp. 103.7 F). Daughter reported that she became non-responsive with high fevers, and when the fevers decreased she was more lucid. Her condition rapidly progressed to nausea vomiting, diarrhea and patient died on 2/9/2021.",Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,OTH,Unknown,Inpatient admission to Medical Center 12/26/2020 - 01/07/2021 for Congestive Heart Failure,"Pulmonary Hypertension, Congestive Heart Failure, Insulin Dependent Diabetes, Oxygen dependant",,Unknown,"['Death', 'Diarrhoea', 'Musculoskeletal discomfort', 'Nausea', 'Pain', 'Pyrexia', 'Unresponsive to stimuli', 'Vomiting']",1,MODERNA,IM 1050173,TN,64.0,F,Pt complained of swelling of left side of face and feeling as if her throat was swelling.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PUB,,,,,,"['Oropharyngeal discomfort', 'Swelling face']",1,PFIZER\BIONTECH,IM 1050174,UT,63.0,F,"Patient was vaccinated 1/18/21 and 1/28/21. 1st dose was not indicated on vaccination card so another dose was given on 2/18/21 under the assumption that it was the 2nd dose. Upon talking to Care Center, Patient was not at their facility on 1/18/21. She was at another Care Center. They did not get any vaccination card or vaccine history from center upon transferring patient to care center.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,SEN,,,,,,['Extra dose administered'],3,PFIZER\BIONTECH,IM 1050175,NM,64.0,M,"Worsening pneumonitis, hypoxemia, hypotension requiring hospital admission. Had had mild hypoxemia without other symptoms starting 1/25/2021, shortly before first dose of COVID19 Pfizer on 1/27/2021 and after he had been considered clinically recovered from acute COVID19 illness on 1/14/2021.",Not Reported,,Yes,Yes,2.0,Not Reported,N,02/17/2021,02/21/2021,4.0,PVT,"insulin, omeprazole, pregabalin, aspirin, carvedilol, canagliflozin, atorvastatin, metformin, ferrous gluconate, loperamide",acute COVID19 disease; test + 1/4/2021; considered recovered 1/14/2021,"Type 2 diabetes, esophagitis, hx RIND/TIA",,vancomycin,"['Blood pressure systolic increased', 'Chest X-ray abnormal', 'Fibrin D dimer increased', 'Hypotension', 'Hypoxia', 'Lung opacity', 'Magnetic resonance imaging abnormal', 'N-terminal prohormone brain natriuretic peptide increased', 'Pneumonitis']",2,PFIZER\BIONTECH,IM 1050176,FL,73.0,M,"Severe pain at injection site. Fever to 100.8, averaging 99.6 over one day - starting on second day after injection. Fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,SEN,"Rx ? Vicodin, 5-325 ? � tablet in afternoon Rx ? Zolpidem, 10mg/night Rx ? Pravastatin, 40 mg/day Rx ? Metoprolol ER Succinate, 50 mg/day Rx ? Pantoprazole, 40 mg/day OTC ? Fluticasone Propionate 200 mcg (2 sprays each nostril before bed)","Oral surgery for bone graft on 2/1/2021 with Augmentin and Metronidazole through 2/9/2021. Knee pain ongoing - possibly meniscus bruise or arthritis. Shoulder pain from dislocation, tears to biceps, deltoid, rotator cuff, supraspinatus and resulting surgery in 2019. Recurring bouts of neuropathy.",COPD.,,None,"['Fatigue', 'Injection site pain', 'Pyrexia']",2,MODERNA,IM 1050177,CA,49.0,F,"Redness, heat and swelling in large area around injection site - 9 days after vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/20/2021,9.0,OTH,"enalapril, verapamil, HCTZ/triamterene",none,hypertension,,none,"['Injection site erythema', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 1050179,,65.0,F,Headachy. Feel very soundly asleep for 3 hrs on day of shot. Same thing next day. Woozy head most of the day. Considered not drivinv.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,PVT,Leo thyroxine .15 Lexapro 10,None,Papillary thyroid cancer (diag 1987),,Penicillin Raw tuna,"['Dizziness', 'Headache', 'Impaired driving ability', 'Somnolence']",2,PFIZER\BIONTECH,SYR 1050180,TX,71.0,M,"swelling, chills, diarehea, pain all lasting 3 days",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,OTH,"tramadol, licinapril .25, low dose asprin",none,pre diabeties,,none,"['Chills', 'Diarrhoea', 'Pain', 'Swelling']",UNK,MODERNA, 1050181,CA,49.0,F,"From patient notes: 2/4/2021 shot at 0700 - arm sore right away 1000 slight headache 1300 chills, increased arm pain, headache a little worse, loss of appetite PM - muscle soreness throughout whole body, hard to sleep 2/5 muscle soreness continues, tired, slight chills 2/6 1300 lips and lower part of face slightly numb and continued throughout day 2/7 numbness not as bad but more on right side and now experiencing sensation of swelling on right side of face 2/8 numbness better but still slight. Slight swelling as well.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/04/2021,0.0,PVT,,,,,,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Insomnia', 'Limb discomfort', 'Pain', 'Swelling face']",2,MODERNA,IM 1050182,NY,74.0,M,"I WOKE UP WITH SEVERE ACHEA AND PAIN IN MY NECK, SHOULDER, BACK, AND THIGHS. I TOOK 1 5MG OXYCODONE HCL PILL THAT SUCCESSFULLY RESOLVED THE PAIN IN A FEW HRS. NO RECURRENCE OR OTHER PROBLEMS SINCE THEN",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/18/2021,2.0,OTH,"TACROLIMUS, CELLCEPT, PREDNISONE, MRTOPROLOL, BACTRIM, BABY ASPRIN, MAGNESIUM OXIDE, BUMETANIDE, CALCIUM, VIT D3, FERROUS SULFATE, VITAMIN C, APRAZOLAM",no,had a double lung transplant at Temple on 03/19/20.,,"ADVAIR, ASMANAX, FORADIL, TRAMADOL","['Arthralgia', 'Back pain', 'Neck pain', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 1050183,UT,46.0,M,Extreme aching pain at injection site. Pain 7 out of 10. Pain lasted for 2-3 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/21/2021,1.0,PHM,Vit C 1000mg Amlodipine 5mg HCTZ 12.5mg Ferrett's Iron Vit D3 125mcg Vit D2 1.25mg Adderall 10mg Adderall 20mg,None,None,,None,['Injection site pain'],2,PFIZER\BIONTECH,IM 1050184,MN,53.0,F,"Patient experienced blister-like wound below injection site. It has since become and open wound with an apparent infection. The injection site is draining, read, and quite large. Patient was seen by a physician and- Clinic.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/15/2021,6.0,PUB,None reported.,None reported.,None reported.,,None reported.,"['Infection', 'Injection site infection', 'Injection site vesicles', 'Wound']",2,MODERNA,IM 1050185,NM,55.0,F,"Fever (up to 101.6), severe headache, joint pain, nausea vomiting chills, increased heart rate (from normal 55 bpm to remaining 80-116 bpm). Severe for over 48 hours and then another 48 hours approximately of moderate symptoms. Lingering mild headache and joint pain remain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,UNK,"Atorvastatin, estroven, two baby aspirin, focus factor vitamins (2) daily",,APS (antiphospholipid antibody syndrome),"1st covid vaccine, 55, 1/20/21, Moderna",Sulfa drugs,"['Arthralgia', 'Chills', 'Headache', 'Heart rate increased', 'Nausea', 'Pyrexia', 'Vomiting']",2,MODERNA,SYR 1050186,CA,67.0,M,Sever shoulder pain that's laster over 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,OTH,"Azelastine HCL Nasal Spray: 0.1% (1x per day) Budesonide Inhalation Suspension: 0.5 mg/2 ml (As needed, 2x per day max.) Bupropion: 300 mg XL 24 hour tablet (1x per day) Diclofenac Sodium Topical Gel, 1% (As needed, about 15 ml, 2x per day)",Hay fever Chronic head pain,Hay fever Chronic head pain from a car accident (The car flipped over and the roof collapsed),,Penicillin Tetracycline Septra,['Arthralgia'],UNK,MODERNA, 1050187,,50.0,F,Pt got vaccine 12/23/2020- then herpes zoster 1/7/2021 so started Valtrex. Started bleeding 1/10/21 and was admitted with platelet count of zero 1/11/2021. Diagnosed with ITP and is responding to prednisone. Also got IVIG. Of note- her dad has a h/o ITP as well and was on Rituxan and also developed low platelet count with each of his COVID vaccines.,Not Reported,,Yes,Yes,,Not Reported,Y,12/23/2020,01/11/2021,19.0,WRK,"Valtrex,",had outbreak of zoster 1/7/2021,,,droperidol,"['Condition aggravated', 'Haemorrhage', 'Herpes zoster', 'Immune thrombocytopenia', 'Immunoglobulin therapy', 'Platelet count decreased']",UNK,PFIZER\BIONTECH, 1050188,NY,47.0,F,"After receiving this 2nd dose of the Moderna Vaccine (Covid-19 vaccine) in my right arm on Friday, Feb. 19 at 4:00 PM, approximately 24-36 hours later I noticed an itching sensation on the same arm. I didn't think much of it. The next day, on Sunday I happened to see my arm in a mirrror and noticed a big res splotch, not on, but close to the shot location. The big red splotch reminded me a lot of a hive. It was very itchy, but also very sore when touched. I thought it odd because I did not have any other hives anywhere else on my body--it was just this one. After doing some research on the internet I discovered that this was probably known as ""Covid Arm"". What I thought was interesting about mine though, was that, in all the articles I read online about Covid Arm, it seemed that people who got this got it 5 to 8 days after their 1st dose. I felt mine was interesting because it appeared for me after only 24 -36 hours, and it appeared only after my 2nd dose. I had no such side effect after dose #1.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/21/2021,2.0,PVT,Levothyroxin 125 mcg tab Levemir Flex-Pen insulin Humalog Kwik-Pen insulin Metformin 500mg tablets (2 tablets 2 times/day) Low-Ogestrel Rosuvastatin 20mg tab Daily aspirin (81 mg) Vitamin D3 2000 IU (equivalent to 50 mcg)--1 tablet per day,None,Type 1 Diabetes Hypothyroid High cholesterol,,Sulfa,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site urticaria']",2,MODERNA,SYR 1050189,CA,53.0,F,"1st vaccine: Patient reports hives 4-6 hrs later, took Benadryl, itching stopped within 24 hrs, spots remained (upper calf to her knee) 2nd vaccine: talked with her doctor who agreed it was a good idea to preload with Benadryl, she stated that she took several doses for 24 hours after vaccine and thought she was still in the clear. Wed 2/17 hives started at work, itching arms and legs, noticed hives/spots left elbow, several both hips, a few more on legs near previous spots from 1st dose, both fingers swollen and red with some bumps, felt ""unwell"" and achy ""grumpy"" for 24-48 hours- took Benadryl, could not take Benadryl 2/19/21 because she had to work, itching is better 2/19 and she feels okay, spots remain.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/11/2021,0.0,PVT,"Benadryl, Proton Pump Inhibitor (Rabeprazole) for acid reflux, Advair inhaler taken for asthma, Wellbutrin antidepressant, vvyanse for attention deficit",,"asthma (at times severe, but she stated that it is okay lately), GERD,",,"latex, bananas, citrus fruits, kiwi, augmentin, sulfa, levoquin, metoclopramide","['Erythema', 'Malaise', 'Mood altered', 'Pain', 'Peripheral swelling', 'Pruritus', 'Urticaria']",2,PFIZER\BIONTECH,IM 1050190,GA,48.0,F,"I received the first vaccine 1/11/2021 and the second dose on 02/03/2021. On 02/16/2021 my hair fell out in clumps. I am post COVID and was Dx on 07/14/2020. I was discharged from the hospital on 09/17/2021. From my stay in the hospital on 07/14/2020 up until 02/15/2021 I had the minimum hair loss that one would loss in a day. I am not sure if the vaccines caused it , but my hair literally came out in clumps. I also started experiencing heart palpitations along with SOB in the evenings after the first vaccine. Upon the second week in February, I started experiencing the palpitations and SOB in the evenings. Again, I am not sure if the vaccines caused this as I am post COVID.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,02/16/2021,36.0,PVT,"Verapamil 240mg Q Day, Losartan 100mg Q Day, Spironolactone 25mg Q Day, Carvedilol 12.5mg BID, Zoloft 50mg Day, Bupropion 300mg Q Day, Crestor 10mg, Q Day, Omeprazole 40mg Q Day, ASA 81mg Q Day, Zyrtec 10mg Q Day, Trazadone 100mg QHS","Post Covid, Hypertension, Depression, GERDS, Hyperlipidemia, Allergic rhinitis, insomnia, elevated heart rate post COVID","Depression, GERDS, Hyperlipidemia, Allergic rhinitis, insomnia, Hypertension",,"Morphine, Dilaudid, Percocet","['Alopecia', 'Blood glucose', 'Blood magnesium', 'Blood thyroid stimulating hormone', 'Blood urea', 'Chest X-ray', 'Computerised tomogram', 'Differential white blood cell count', 'Dyspnoea', 'Electrocardiogram', 'Fibrin D dimer', 'Full blood count', 'Metabolic function test', 'Palpitations', 'Thyroxine free', 'Troponin I']",1,PFIZER\BIONTECH,IM 1050191,SC,57.0,F,"Pain, swelling and redness with urticaria by her description of the entire injected arm (above elbow). This resolved except for persistent soreness until 2/22/2021 at office visit. No visible abnormality at the visit. Seventeen days after the vaccination she developed 2 mm pink round papules on the lower extremities with improvement over the next 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/07/2021,4.0,PHM,Black Elderberry (SAMBUCUS ELDERBERRY) 50 mg/5 mL SYRP diphenoxylate-atropine (LOMOTIL) 2.5-0.025 mg tablet eszopiclone (LUNESTA) 3 mg tablet fenofibrate 160 MG tablet gabapentin (NEURONTIN) 300 mg capsule HYDROcodone-acetaminophen (NORCO),None,"Back pain Chronic pain Cystocele, midline Disturbance in sleep behavior Dyslipidemia Menopause present Mixed incontinence Reactive depression Spasm",,Augmentin,"['Full blood count normal', 'Injection site erythema', 'Injection site pain', 'Injection site papule', 'Injection site swelling', 'Injection site urticaria']",1,MODERNA,SYR 1050193,UT,32.0,F,"I felt ok at first, then I got really hot, then it went away pretty quick. My face kinda felt funny. After about 20 minutes, I couldn't feel the left side of my face and the left side of my body was like with you go to the dentist and have lidocaine. The next day I felt like I had been hit by a mack truck. I felt like that until about January 6, 2021. I also had SOB, joint pain, headache, extreme fatigue and body aches, sore arm and redness at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,PUB,I take Celexa.,No,No,,I am allergic to NSAIDS.,"['Arthralgia', 'Dyspnoea', 'Fatigue', 'Feeling hot', 'Headache', 'Hypoaesthesia', 'Injection site erythema', 'Malaise', 'Pain', 'Pain in extremity', 'SARS-CoV-2 test positive']",1,MODERNA, 1050194,MT,19.0,M,Began feeling short of breath and dizzy. Was given 25mg Benadryl PO and symptoms resolved,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,PVT,,,,,NKA,"['Dizziness', 'Dyspnoea']",1,PFIZER\BIONTECH,SYR 1050195,FL,43.0,F,Acute sensorineural hearing loss right ear,Not Reported,,Not Reported,Not Reported,,Yes,N,01/09/2021,02/13/2021,35.0,PVT,Atorvastatin 40mg ASA 81mg Spironolactone 100mg Vit D 1000 units,None,Migraines History cryptogenic stroke secondary to patent foramen ovale Sept 2020,,None,"['Audiogram abnormal', 'Deafness neurosensory']",2,PFIZER\BIONTECH,IM 1050196,MT,37.0,M,Reported that he began to feel dizzy after injection. Was taken to urgent care clinic for monitoring. Was noted to be hypertensive. Was monitored and blood pressure returned to safe level within 30 minutes. Was discharged home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,PVT,,,,,,"['Dizziness', 'Hypertension']",1,MODERNA,SYR 1050197,MI,38.0,F,"Within 30 minutes, I turned bright red - my face and my forearms. Not a rash or raised rash. It was a deep red flushing. I took a dose of oral Benadryl it didn't go away. It felt like a sunburn. I had a headache starting at the back of my head. 1st and second day, I had pain in my joints. Not muscular pain. It came and went the joint pain - behind my left knee was hurting really bad and then it went away. Then my right wrist would start hurting and then it would go away, etc. The second day, the headache was more mild - like a mild pressure in my head. The redness was still there - the red face and red arms. My left arm at the site was cherry red and about the size of two inch circle and somewhat raised. The third day, my headache was worse. It was not like a normal headache but an overall pressure in head. Pink and a bit larger but didn't hurt as bad on arm- the redness continued for six days on my face. The headache lasted 14 days straight - Motrin, ice, heat and extra sleep was tried for treatment. On 15th day it started to let up. On 16th day, it was very mild headache. On the 17th day, it was a full blown headache again. Day 18 it was gone. On the second week, I had mild pain in my stomach and then that went away. On day 3, I had about an hour - twice that day - where I was short of breath and then it went away - it was just that day - about noon and at night. I took Benadryl and when I woke up that didn't happen again. Doctor called on day 12 - when my headaches weren't going away. He took some labs. My labs were normal except thyroid (and I already have a condition for my thyroid). Dr. gave me a medication for headache but I didn't take it - it had a possibility of making me tired and I didn't want to take it.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,PVT,Synthroid,no,thyroid - auto-immune issue *Hashimoto's Disease - hypothyroid goes along with it,autoimmune reaction to the flu vaccine before but that was many years ago - my immune system flared up.; haven't taken any flu v,penicillin - hives,"['Abdominal pain upper', 'Arthralgia', 'Dyspnoea', 'Erythema', 'Flushing', 'Full blood count normal', 'Head discomfort', 'Headache', 'Immunoglobulins', 'Injection site erythema', 'Injection site swelling', 'Metabolic function test', 'Skin burning sensation', 'Thyroid function test abnormal']",1,PFIZER\BIONTECH,SYR 1050198,GA,78.0,M,"Got up to go to the bathroom in the middle of the night, was dizzy. Wife walked with him because of the dizziness. On way back to bed he passed out and I tried to help ease him down. Came back almost immediately. Got on hands and knees and crawled to bed. Ran a fever of 100.3 all Wednesday and stayed in bed because of dizziness. By Thursday he was fine again and started doing his normal activities.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PHM,"Aspirin, Vitamin B12, C, D, Gabapentin, Levothryoxine, Losartan, Amlodipine, Atorvastin, Doxazosin, Sertraline, CoQ10, Neuriva and sleep aid",none,none,,sulfa,"['Dizziness', 'Loss of consciousness', 'Pyrexia']",UNK,MODERNA,IM 1050199,CA,73.0,F,"fever, chills, foggy head, nauseated",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,SCH,"calcium, vitamin b, fish oil, protonix, metoprolol 50mg, Cozaar 100 mg, Amitriptyline 10mg,",,hypertension,,penicillin,"['Chills', 'Feeling abnormal', 'Nausea', 'Pyrexia']",2,MODERNA,IM 1050200,MT,38.0,M,Reported that he began to feel dizzy after injection. Was taken to urgent care clinic for monitoring at 1100. Was noted to be hypertensive. Was given 0.1mg Clonidine PO at 1205. Was discharged with safe blood pressure at 1345,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,12/23/2020,,PVT,,,,"Multiple vaccines, COVID 19 vaccine on 12/23/20, always get dizzy and hypertensive",,"['Dizziness', 'Hypertension']",2,MODERNA,SYR 1050201,MT,77.0,M,Died 7 days after receiving 2nd dose of Moderna vaccine. Had underlying hx Lung CA w/mets.,Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/09/2021,7.0,PVT,multiple,Metastatic Lung Cancer,see above,,NKA,['Death'],2,MODERNA,SYR 1050202,AZ,45.0,F,"Covid Arm On Sunday my arm was very red, swelled up, puffy, hot to the touch, and itchy",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/21/2021,8.0,PHM,None,None,I?m anemic other than that I?m healthy,,None that I know of. I have what it looks like to be Moderna Covid Arm. I have photos of my arm too. It now looks to be going away but it?s still very red at the site.,"['Erythema', 'Pruritus', 'Skin warm', 'Swelling']",1,MODERNA,SYR 1050203,MI,75.0,M,"10+ hours of confusion, that was thought to be ictal or post-ictal confusion. Next day, resolved, but he could not remember that 10+ hours period of time.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/13/2021,02/20/2021,7.0,PVT,"Keppra 250mg once daily, gabapentin 300mg three times a day, atorvastatin 10mg, metformin 500mg twice per day",,"brain meningioma, epilepsy, hypercholesterolemia, h/o prostate cancer s/p prostatectomy, diabetes",,none known,"['Blood test normal', 'Computerised tomogram normal', 'Electrocardiogram normal', 'Electroencephalogram normal', 'Magnetic resonance imaging normal', 'Postictal state']",2,PFIZER\BIONTECH,IM 1050204,MT,29.0,F,"Large area of redness, pain, swelling and lymphadenopathy noted after first dose. Symptoms resolved after 7 days. Does not want second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,,,,,Morphine,"['Erythema', 'Lymphadenopathy', 'Pain', 'Swelling']",1,MODERNA,SYR 1050205,NJ,48.0,M,"Started with tiredness, then arm got sore and was painful to lift. Later in the day, body and joint aches started. 12 hours after dose, started to get very cold and this turned into violent and uncontrollable shaking from chills. Then headache started 13 hours after dose (the headache lasted for 2 days and was the last symptom to go). Fever fluctuated between 101.5 and 102.1. Later felt very nauseous, felt like I had to vomit but didn?t. Went to the bathroom and there I got dizzy and almost passed out but didn?t. Fever up and down all day the next day. Could only eat a little Campbell?s chicken noodle soup and a small can of coke. By the next evening (day 2) I started to feel better just exhausted and a headache. Went to sleep early, next day (day 3) still had the headache and was exhausted. By Day 4 I was about 80 % back to normal and feeling much better. I didn?t take any fever reducers or other medications during this time. It was all worth it to be vaccinated,",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,PUB,"Vitamin D3, B12, Magnesium,",None,None,,Seasonal allergies,"['Arthralgia', 'Chills', 'Dizziness', 'Fatigue', 'Feeling cold', 'Headache', 'Hypophagia', 'Nausea', 'Pain', 'Pain in extremity', 'Presyncope', 'Pyrexia', 'Tremor']",2,MODERNA, 1050206,MD,30.0,F,"I had hives despite having taken my daily dose of Claritin that seemed to get worse as the day continued. I reached out to my Healthcare clinic and they were unsure if there was a simple treatment and almost required me to go the emergency room for this. I conducted a telehealth consultation with a doc who was not my primary care physician and was unfamiliar with my preexisting exercise urticaria condition that occasionally results in light hives but never anaphylaxis for me without Claritin. I declined going to the emergency room since this did not seem that serious and instead took another Claritin to try to get the somewhat worsening hives with no apparent cause to stop without an unnecessarily escalated situation. My throat was slightly itchy but I never became anaphylactic likely due to taking an additional Claritin and not doing anything requiring physical effort for the day beyond telecons from home because I left the office to telework mid morning after I started getting continually slightly worse hives. By evening I was ok and the next day just had a slightly sore throat but was able to work and just started the day with 2 Claritin without any further instance of hives appearing. The day after that I returned to my standard 1 Claritin dose with no ill effects. From this event, it seems clear that a 72 hour downing period from dose 1 is insufficient and should be upped to 96 hours. Prior to this more severe event, I had, on days 2 and 3, a sore left arm at injection site that prevented me from even reasonably lifting my arm to a height sufficient to grab my cell phone off it's charger while lying in bed without serious discomfort. That level of arm discomfort prevented me from working out or would have prevented me from anything other than light office work involving my vaccine arm. My level of tiredness for the couple days following this dose also required that I take an hour long nap days 1 and 2, and no nap at all is usually the norm for me.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/11/2021,3.0,MIL,"Claritin, Ibuprofen, Mirena",None,Exercise induced urticaria (controlled by one daily Claritin),,None,"['Fatigue', 'Impaired work ability', 'Injected limb mobility decreased', 'Injection site pain', 'Oropharyngeal pain', 'Pain', 'Throat irritation', 'Urticaria']",1,MODERNA,IM 1050207,CA,69.0,M,"""horrible side effects that feels like I am have COVID all over again"" -- very dizzy, terrible headache, left side of throat sore, temp of 100.2, chills, night sweats, can barely stand",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/17/2021,0.0,PVT,,,prior COVID-19 illness in November 2020,,,"['Chills', 'Dizziness', 'Headache', 'Night sweats', 'Oropharyngeal pain', 'Pyrexia']",1,MODERNA,IM 1050208,CA,28.0,F,"Fever, chills, body ache, nausea, tiredness and fatigue for 36h, sore site of injection for 4 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PVT,birth control,,,,,"['Chills', 'Fatigue', 'Injection site pain', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 1050209,MI,43.0,F,"I got a rash all over my chest and neck within a few hours of the vaccine. The rash went away about 24 hours later. I also got a rash around the band-aid I had from the vaccine. I know that a sore arm is normal for shots and vaccines, but my arm was sore unlike any time before. It was awful!",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,OTH,"Adderall, Vitamin D, B12, Multivitamin, Cabergoline, levothyroxine, aspirin, magnesium, fish oil, calcium, Zyrtec, and biotin",Just finished my period,"I have a pituitary adenoma and Hashimoto's Disease. In addition, I have high triglycerides and clogging carotid arteries,",,Penicillin,"['Injection site rash', 'Pain in extremity', 'Rash']",2,MODERNA,SYR 1050210,MT,43.0,F,"Began feeling itchy in the roof of mouth. Began coughing. Felt like her blood pressure was dropping. Received 20 mg IV Famotidine, 10 mg IV Dexamethasone, 0.3 ml sub Q Epinephrine, 25 PO Benadryl and 1 liter Normal Saline. RN documents that blood pressure did drop to 107/64, but did not become hypotensive. Discharged in stable condition at 1500. Doctor recommended that she not receive second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,PVT,,,,,"Other Vaccines, specific ones not documented","['Blood pressure decreased', 'Cough', 'Oral pruritus']",1,PFIZER\BIONTECH,SYR 1050211,CA,80.0,M,"Immediately he had a headache associated with dizziness and the headache persisted. He was known to be unstable on his feet with muscle weakness. Other complaints include shortness of breath, confusion, decreased appetite. O2 saturation dropped from 90% to 80% on room air. He complained of low back pain and weakness and heart rate of 115.",Not Reported,,Not Reported,Not Reported,,Not Reported,,01/14/2021,01/14/2021,0.0,UNK,,,,,,"['Asthenia', 'Back pain', 'Confusional state', 'Decreased appetite', 'Dizziness', 'Dyspnoea', 'Gait disturbance', 'Headache', 'Muscular weakness', 'Oxygen saturation decreased']",1,PFIZER\BIONTECH,IM 1050212,TN,77.0,F,"Experienced bad taste in my mouth right away, lips felt weird, breathing very raspy, chills, itching on head, ears, arms, headache, swallowing issues, stuffy nose, sinus pressure, extreme fatigue, dry mouth (felt like cotton in my mouth), temperature dropped. Took about five days to feel okay. Took Benadryl (took twice with six hours between doses, took antihistmine, Levocetiriine, used pro air quite often, 20 mg of Prednisone at 2:30 am on the 22 and finally felt relief. Dr.. was informed after I got better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,PVT,"Zetia, Lady Bayer, Breo ellipta, Levocetirizine, Fluticasone Propionate Nasal Spray, Lady Centrum silver, Calcium, D3",,"Allergies, Asthma, kidney disease( stage 3).",,"E-Mucin, Sulfa, Ceftin, Clindamycin, Cipro, Penicillan/Amoxicillin (? had skin test and show I am no longer allergic) , Hydrocodone, Doxycyclin, Dilaudin.","['Body temperature decreased', 'Cheilitis', 'Chills', 'Dry mouth', 'Dysphagia', 'Ear pruritus', 'Fatigue', 'Headache', 'Immediate post-injection reaction', 'Nasal congestion', 'Paranasal sinus discomfort', 'Pruritus', 'Stridor', 'Taste disorder']",UNK,PFIZER\BIONTECH, 1050213,CA,85.0,M,"Localized redness and nodule s/p vaccine administration. Pt A/Ox4, Skins normal for ethnicity. Resp unlab and even. NAD. Denies any other s/sx at this time. Ice pack applied to site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,OTH,"""b/p"" meds",HTN,HTN,,NKA,"['Erythema', 'Nodule']",1,PFIZER\BIONTECH,IM 1050214,CA,58.0,F,It made throat inflamed and made it hard to swallow and breath.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,PVT,"Hydroxychloroquine,omprezole, Premarin,Mondofinil, Doxipinil,Fish oil, Daily Vitamin Losartan, Bupropian",None,"Rheumatoid arthritis, menopause, Depression, Anxiety, Gerd, Fibromyalgia, Raynauds, Insomnia, chronic fatigue",,Codeine,"['Dysphagia', 'Dyspnoea', 'Throat irritation']",1,MODERNA,IM 1050215,MT,71.0,M,"Fell in parking lot after leaving clinic after receiving 1st covid vaccine. Does not appear to be related to the vaccine, but may be related to crappy parking lot.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,"insulin, lisinopril, multiple others","ESRD, DM, HTN, CHF, Bilat BKA",see above,,"clindamycin, 1st gen cephalosporins, bactrim, rocephin",['Fall'],1,MODERNA,SYR 1050216,WA,39.0,F,Given Moderna COVID Vaccine as Vaccine # 2 25 days after receiving Pfizer COVID Vaccine # 1 on 1/2/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,WRK,unknown,unknown,unknown,,"Peas, Lentils, Trees, Grass, Weeds, Mold, seasonal allergies, Dogs, Cats, Fragrances.",['Interchange of vaccine products'],1,MODERNA, 1050217,CA,51.0,F,"2/18 6 pm nasaues, dizzy, chills, headache 10 pm 103 fever , nasueas, dizzy, aches,pains, headache 2/19. 10am fainted, vomiting, chills, fever 2/20 fever , felt I was fainting again, extreme body shakes , vomiting , headache, night sweats 2/21 nasueas, dizzy , nightsweats 2/22 nasueas, dizzy, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,OTH,"fosamax,ativan,",,"Covid 3/2020 -still having long haulers (reactive airway disease, tachychardia)",,,"['Chills', 'Dizziness', 'Headache', 'Nausea', 'Night sweats', 'Pain', 'Pyrexia', 'Syncope', 'Tremor', 'Vomiting']",2,MODERNA,IM 1050218,CT,40.0,F,Delayed injection site reaction- itching and swelling,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/23/2021,8.0,PVT,Tamoxifen Folic acid Vitamin D3,,,,NKDA,"['Injection site reaction', 'Pruritus', 'Swelling']",1,MODERNA,IM 1050219,NY,71.0,F,"Delayed reaction five days after vaccine. Headache, mild fever and extreme fatigue. The first two responded to Motrin which I took twice. The fatique was intense and lasted three full days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/18/2021,5.0,PHM,none,none,osteoporosis,,none,"['Fatigue', 'Headache', 'Pyrexia']",1,MODERNA,IM 1050221,MT,34.0,F,Began feeling short of breath and dizzy. Was given 25mg Benadryl PO and symptoms resolved,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,PVT,"Bupropion, Naltrexone","Alcoholism, Meth abuse",Anxiety and depression,,NKA,"['Dizziness', 'Dyspnoea']",1,PFIZER\BIONTECH,SYR 1050222,PA,64.0,F,"About 10 or 11 days after the vaccine, my arm got a red blotch on it near the vaccine injection site It hurt a little when touched. It seems to be lighter in color but is still present. Headaches in the morning and some fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/10/2021,02/20/2021,10.0,PHM,"Folic acid, levy thyroxine, vitamin B6, vitamin B12, vitamin D",None,"Oesteoporosis, thalassemia beta, hypothyroidism",,"Pollen, mold","['Fatigue', 'Headache', 'Injection site pain', 'Injection site rash']",1,MODERNA, 1050223,IL,37.0,F,Severe body cramps/spasms - started approximately 1am and continued sporadically through the day on Tuesday Drank pedialyte Fever- 101.6 was highest Took Tylenol,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/23/2021,1.0,PUB,Zolpidem Tramadol amitriptyline Nurtec,None,None,,Penicillin,"['Muscle spasms', 'Pyrexia']",2,MODERNA,IM 1050224,MT,29.0,F,"Large area of redness, pain, swelling and lymphadenopathy noted after first dose. Symptoms resolved after 7 days. Does not want second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/24/2020,1.0,PVT,,,,,Morphine,"['Erythema', 'Lymphadenopathy', 'Pain', 'Swelling']",1,MODERNA,SYR 1050225,AZ,45.0,F,"Extreme rapid heart rate that caused intense heart palpitations, breathing issues that required inhaler use, insomnia & horrible nightmares",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/28/2021,27.0,PVT,"Miralax &Nexiuum, Cardizem",,PVC (heart) Asthma,,"Peanuts, Penicillin, Darvocet, Keflex","['Cardiac monitoring', 'Cardiac stress test', 'Heart rate increased', 'Insomnia', 'Nightmare', 'Palpitations', 'Respiration abnormal']",1,MODERNA,IM 1050226,NJ,58.0,F,"Suddenly became dizzy, My family who consists of 3 nurses were with me at the time. Had a witnessed vasovagal syncope episode . Turned white, lost consciousness for about 90 seconds. No pulse was felt by my daughter who is APN. 3 chest compressions were done, then color in my skin began to return (per my family). I was then transported to the emergency room. Cardiac work up for heart attack was negative, vital signs were stable after initial episode. Was admitted to hospital for 18 hours for observation. I have no medical history and had no changes in my daily routine",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/12/2021,02/20/2021,8.0,PVT,Lexapro :10mg,,no medical history,,,"['Cardiac function test normal', 'Cardiac telemetry normal', 'Dizziness', 'Echocardiogram normal', 'Electrocardiogram ambulatory', 'Electrocardiogram normal', 'Full blood count normal', 'Loss of consciousness', 'Metabolic function test normal', 'Pallor', 'Pulse absent', 'Resuscitation', 'Syncope', 'Troponin normal']",2,MODERNA,IM 1050227,MN,50.0,F,"Red, swollen spot on left arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/23/2021,0.0,PHM,None,None,None,,Sulfa,"['Erythema', 'Peripheral swelling']",1,MODERNA,SC 1050228,MT,39.0,M,"Began feeling short of breath and dizzy. Taken to urgent care and monitored. Symptoms resolved without intervention. Provider stated that it appeared to be anxiety, not ADR.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PVT,,,,,"Tape, Plastic","['Anxiety', 'Dizziness', 'Dyspnoea']",1,MODERNA,SYR 1050229,NV,75.0,M,"High blood pressure, constant ringing in the ears much worse in the morning, nausea, lightheadedness, dizziness, a sick feeling all of the time. He doesn't feel right.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,PVT,no,no,no,,no,"['Dizziness', 'Feeling abnormal', 'Hypertension', 'Malaise', 'Nausea', 'Tinnitus']",1,MODERNA,IM 1050230,NV,48.0,F,transient rash to bilateral legs,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PUB,"Benzonatate, Sertraline, Losartan, Augmentin, Metoprolol","fatigue, diarrhea, Hypertension",HTN,,none,['Rash'],1,PFIZER\BIONTECH,IM 1050231,OH,53.0,M,"as I mentioned, he had a fever and aches one day prior to the first vaccine. following the vaccine the fever spiked as high as 103 and fatigue continued. four days later a rash developed on his back, and a dry cough developed. He also is experiencing and continues to experience some numbness/tingling in his legs and arms. Two Saturdays following the vaccine he went to the ER and was diagnosed with pneumonia in both lungs. However, a fourth covid test was given and it was negative like the previous three tests.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,SCH,tylenol,"low grade fever and body aches one day before (2/11/21). Went to the doctor, got a negative rapid covid test and was told I could get the vaccine even with a low fever since my covid test was negative.",,,,"['Computerised tomogram thorax abnormal', 'Cough', 'Fatigue', 'Hypoaesthesia', 'Paraesthesia', 'Pneumonia', 'Pyrexia', 'Rash', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,SYR 1050232,TN,53.0,F,Left arm red and warm to the touch. Started itching first and then became red in a circular diameter of about 4 inches. Tender and warm when touched. Started the seventh day after vaccine and woke up on the eighth day and it was a lot worse. Also feels like a knot under the skin.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/22/2021,7.0,PHM,,None,Hypertension,,Penicillan,"['Erythema', 'Pruritus', 'Skin mass', 'Skin warm', 'Tenderness']",1,MODERNA,SYR 1050233,CA,35.0,F,"pt w hx of vagal events with vaccinations and blood draws. shortly after vaccine administration, became nauseated, pale, and dizzy. improved after 30 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,PVT,,,,,,"['Dizziness', 'Nausea', 'Pallor']",1,PFIZER\BIONTECH,SYR 1050234,VI,70.0,F,"nausea, chills fatigue, headache, generally feeling unwell. very swollen arm and covid rash around injection site; advill and rest until subsided. about 1 week. First shot the worst. Second shot, not too much.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/23/2021,1.0,PHM,"Wellbutrin, allegra D",none,none,,"penicillin, sulfa drugs","['Chills', 'Fatigue', 'Headache', 'Injection site rash', 'Injection site swelling', 'Malaise', 'Nausea']",UNK,MODERNA,IM 1050235,MI,38.0,F,"Within 30 minutes, I started to have a very mild headache. It felt like a pressure headache. I took Motrin. About 6 hours later that was gone. That night, about 8 hours after vaccine, I began to have muscle aches - whole body. I was very sore. I went to bed. Next day, I had severe joint and muscle aches and pains. The Motrin did not help that. Ice did not help, heat did not help and rest did not help. No headache. I wasn't red in face etc. Over the next week, I the muscle aches and joint aches were varying between moderate to severe. Some days it did restrict my activity completely. It started to get better week two - but still moderate to severe. I had some abdominal pain on upper left side and my right side (upper, as well) The upper right side pain would go away with ice but the upper left side wasn't helped with that. The only thing in those two weeks that helped was Celebrex (Motrin stopped helping). After two weeks - around 2/5/2021, I saw my Dr - a virtual visit. He told me to double up on the dose of Celebrex to help with muscle aches, joint aches and right side abdominal pain. Heart palpitations - irregular heartbeat. On 2/7/2021, I took a test for COVID and it was negative. The joint and muscle aches were moderate to mild the third week. There was no more abdominal pain in third week. Week 4 - mild joint and muscle aches - only a few days that week and that was it. Last week was the first week where I had a few days that were fine. And this week, I have been completely fine. Had general malaise for three weeks solid. And now it's gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,PVT,Synthroid,adverse symptoms of dose 1 of the Pfizer Covid Vaccine,thyroid - auto-immune issue *Hashimoto's Disease - hypothyroid goes along with it,COVID19 Pfizer Dose 1 of Covid - 12/2020; flu shot many years ago that I had an immune response to. Haven't had a flu shot since,penicillin,"['Abdominal pain upper', 'Arthralgia', 'Head discomfort', 'Headache', 'Heart rate irregular', 'Loss of personal independence in daily activities', 'Malaise', 'Myalgia', 'Palpitations', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,SYR 1050236,PA,30.0,M,"- Low fever (99.4-99.8 degrees F) during evenings each night after the vaccine, treated with one dose of 500 mg Tylenol - Increased irratibility, anxiety, muscle tension in neck and chest off and on (1 episode lasting about 10 min every 1-2 hrs). Starting occuring ~ 48 hours after receiving vaccine. Current treatment is laying down until the anxiety passes as needed per episode.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/21/2021,2.0,WRK,"sertraline, bupropion, clonazepam, atorvastatin, nexium",,"generalized anxiety disorder, depression, Asperger's syndrome, high cholesterol",,allergic to amoxicillin and penicillin,"['Anxiety', 'Irritability', 'Muscle tightness', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1050237,NY,35.0,F,"Dizziness, vestibular neuritis, continuous since 1/20.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/20/2021,16.0,PVT,"Allegra, Flonase, prenatal vitamins, vitamin d3",Miscarriage and D&C on 12/30/20.,"Asthma, hyperlipidemia","Polio vaccine in childhood- pain, brief paralysis of legs? Guardisil- arm numbness and tingling, lightheaded ness","Amoxicillin, sulfa, environmental","['Borrelia test', 'Dizziness', 'Full blood count', 'Human chorionic gonadotropin', 'Magnetic resonance imaging head', 'SARS-CoV-2 test', 'Vestibular neuronitis']",1,PFIZER\BIONTECH,IM 1050238,CA,69.0,F,"Telephone call with urgent care MD on 2/18/21 for c/o of itchy pink blotch at injection x3 days. Pt had received Moderna vaccine dose 1 on 2/4/21. Patient did not notice anything sxs after receiving the Moderna vaccine until the past 3 days (from when she called urgent care) as she had noticed the injection site area was itchy. Patient is unsure if symptoms were there prior and she only noticed the itchiness the past 3 days and more noticeable when scratched. Feels slightly swollen/firm and warm per patient; but denies any pain in arm. Patient denies any other symptoms such as fever,dyspnea, boady aches, arm weakness. Pt has normal range of motion. Pt was recommended to try topical hydrocortisone, massaging, for a few days. If persists or becomes painful or tender, pt should return for inperson exam.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/18/2021,14.0,PVT,,,,,NKDA,"['Injection site induration', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,IM 1050239,OH,29.0,F,"Left arm experienced a numbness-like feeling from shoulder to elbow, as well as a heavy feeling. After about 20 minutes the numb like feeling had begun to regress back toward the injection site. It had not fully faded away after 30 minutes but did seem to be improving.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,OTH,,,,,,"['Hypoaesthesia', 'Injection site hypoaesthesia', 'Limb discomfort']",2,PFIZER\BIONTECH,IM 1050240,MD,30.0,F,"I had a bad headache despite taking a 600mg Ibuprofen at initial onset of this headache, and felt increasingly overheated and sweaty throughout the night, the headache starting around 1800 day of injection, trouble sleeping and too warm feeling starting closer to 2300, and both headache and overheating lasting through probably about 0300 the following morning. Had I been in the office I would have had to go home ill, and I could not do much but try to rest during this time. The headache through the following day was light and I felt mostly normal by evening.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,MIL,"Claritin, Ibuprofen, Mirena",None,Exercise induced urticaria (controlled by one daily Claritin),,None,"['Feeling hot', 'Headache', 'Hyperhidrosis', 'Insomnia']",2,MODERNA,IM 1050241,CA,52.0,M,"Joint pain was excruciating and at same level as traumatic fracture; fever of 102 with tylenol 500 mg x 2, extremely disturbing nightmares and flashback to military combat.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,PVT,"Gabapentin, Hydroxyzine, Isosorbide, Escatilopram, Rivaroxaban, Ticagrelor, Rosuvastatin, Clonazepam",None,"Chronic nightmares, severe PTSD following military combat (chronic), severe depression, anxiety disorder, severe osteoarthritis knee, multi-level disc degeneration; history of NSTEMI not tied to known disease; traumatic brain injury",,Morphine (anaphylaxis),"['Arthralgia', 'Condition aggravated', 'Flashback', 'Nightmare', 'Pyrexia', 'Traumatic fracture']",2,MODERNA,IM 1050242,CA,68.0,F,"approximately 6pm on 2/18 I began having severe chills, high fever, nausea, muscle weakness, headache, whole body pain lasting 3.5 days. I took aspirin to start for my symptoms first day, 2nd-3rd days Ibuprofen for the fever, chills. IS TAKING DIFFERENT LOT NUMBER WHAT MADE ME ILL???",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,PUB,"Levoxyl 137 mcg, Fosinopril 10 mg, 81 mg aspirin",none,"weight, chronic kidney stones, anemia","ALLERGIC TO IODINE, PENICILLIN (HIVES, INABILITY BREATHE","iodine, penicillin","['Chills', 'Headache', 'Muscular weakness', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,UN 1050244,FL,41.0,F,"Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache. Approximately 24-48 hours after I received the vaccine I started developing a red, hot, itchy raised rash on my ears and buttocks which became more prevalent and peaked around 80-90 hours later. Approximately 82 hours after I received the vaccine, I began to feeI nauseous, dizzy, and fatigued so I stood up to get ready for bed early. While brushing my teeth, I went pale white and felt like I was going to vomit. I put the toothbrush down and got on floor. My pulse felt like it had stopped. I tried to check my pulse and I could only detect one beat every other second. I called for my spouse and by the time he got to bathroom I was passed out. I came back to after about 30 seconds and was convulsing from chills. He put a blanket on me and grabbed my Apple Watch to try to get my pulse which read in the 50s (so I assume it was much lower when I passed out). My hands and feet were tingly and I stayed on the floor until my pulse got back up. I then had diarrhea. At this point in time the rash was most prevalent and was present mostly on my buttocks but also on my ears, scalp, pointer finger on right hand, thighs, and hips. I went to doctor the following morning an my vitals, blood sugar, EKG, urine screen were stable and indicated no issues. 106 hours later I still have the rash on all areas mentioned and am dizzy, nauseous, and fatigued.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/19/2021,02/22/2021,3.0,OTH,"Omeprazole, Aleve",None,None,,No known allergies,"['Anaphylactic shock', 'Blood glucose normal', 'Chills', 'Diarrhoea', 'Dizziness', 'Electrocardiogram', 'Fatigue', 'Headache', 'Loss of consciousness', 'Nausea', 'Pain in extremity', 'Pallor', 'Paraesthesia', 'Pulse abnormal', 'Rash erythematous', 'Rash papular', 'Rash pruritic', 'Seizure', 'Skin warm', 'Urine analysis']",2,PFIZER\BIONTECH,SYR 1050245,TN,82.0,M,"2/17 first occurrence: symptoms = confused speech, memory impairment diagnosis = TIA 2/20 second occurrence: symptoms = confused speech, memory impairment 2/21: symptoms = confused speech, memory impairment, cognitive difficulty understanding others 2/23: unusual behavior (perhaps due to confusion), difficulty driving (almost hit a parked vehicle and a mailbox; and ran off the right side of the road), agitation (upset, because he considered it a waste of time to visit the ER and have more tests run on 2/23; and also upset that people were ""questioning his driving"")",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/10/2021,02/17/2021,7.0,PUB,,,,,,"['Abnormal behaviour', 'Agitation', 'Cognitive disorder', 'Computerised tomogram', 'Confusional state', 'Dysarthria', 'Impaired driving ability', 'Memory impairment', 'Speech disorder', 'Transient ischaemic attack']",UNK,MODERNA,IM 1050246,NY,41.0,F,Vomiting fainting fever,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/23/2021,1.0,OTH,"Fluoxetine, spiranolactone, cryselle, Zyrtec, mucinex",,Seasonal allergies,,"Penicillin, sulfa, clindamycin","['Pyrexia', 'Syncope', 'Vomiting']",2,PFIZER\BIONTECH,SYR 1050247,TX,54.0,F,"Individual received first dose of the two dose series of COVID-19 vaccine - Moderna - on 1/20/2021. Individual received second dose of two dose COVID-19 vaccine - Moderna - on 2/9/21. Second dose of vaccine was due to be administered 2/17/21. Vaccine error - second dose of Moderna administered 8 days earlier than recommended. Physician contacted Infectious Disease Specialist, Dr. who advised no additional dose needed. Individual reports no adverse side effects related to second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,PUB,Losartan and Metoprolol,No,hypertension,,No,"['Inappropriate schedule of product administration', 'No adverse event']",2,MODERNA,IM 1050248,WA,64.0,F,"vaccine 1/6, flu like symptons (achy, fever, tires) 1/7-1/8, low grade temp 1/9-1/10, felt fine 1/11, achy, fever, tired 1/12-1/14, got covid test to double check, negative",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,WRK,"norvasc, diltiazem, micardis, hctz, crestor, vitamin c, vitamin e, calcium,",,"chronic allergies to dust mites, htn, svt",,"prinivil, codeine","['Fatigue', 'Influenza like illness', 'Pain', 'Pyrexia', 'SARS-CoV-2 antibody test negative']",2,PFIZER\BIONTECH,IM 1050249,MI,62.0,M,"Approximately 18 hours after taking the vaccine I woke up with body aches and chills. I was also short of breath. The chills lasted approximately 3 hours. The body aches were not severe but lasted 24 hours, as did the shortness of breath. I did go to work on the the 18th (the morning after the shot), but had to leave work early because I was too short of breath to stand up for very long and I also had trouble focusing on my work.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,OTH,Omeprazole 20mg 1/day Atorvastatin 40mg 1/day,Chronic Obstructive Pulmonary Disease.,Overweight,,"Dust, molds","['Chills', 'Disturbance in attention', 'Dyspnoea', 'Impaired work ability', 'Pain']",2,MODERNA,IM 1050250,NJ,50.0,F,"Injection site has become swollen, very red, raised, hot to the touch and painful. I've applied cold compresses, cortisone cream, and taking Benadryl.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/22/2021,2.0,WRK,"Multi vitamin, D3, Lipator, Xarelto, Protonix, Advair, flonase, Proair, Singular, Xyzal, Allegra, Venlafaxine, Dicyclomine",None,"Crohn's, IDS-D, asthma, post thrombotic syndrome, hypercoagulable disorder",,"Latex, adhesive to tape on bandages, acetaminophen-codeine, moxifloxacin, naproxen","['Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Injection site warmth']",2,MODERNA,SYR 1050251,CA,69.0,F,"After approximately 12 hours, the injection site became red, swollen and itchy with second inoculation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,OTH,Multiple vitamin D3 supplement 1000 IU Triamterene HCTZ 37.5-25 mg Metroprolol Success Er 25 mgs Lovastatin 40 mg,None,BP regulated with meds Cholesterol regulated with meds,,Demerol,"['Injection site erythema', 'Injection site pruritus', 'Injection site swelling']",2,PFIZER\BIONTECH,SYR 1050252,FL,67.0,F,"The patient became acutely short of breath and was unable to speak momentarily. She was waiting the requisite 15 minutes and once we evaluated her she was administered an Epi-pen immediately. In a few minutes, her breathing returned to her baseline and she was able to speak in full sentences. Clinically, her BP was stable and she was not tachycardia. Pulses were strong. Also, given 25 mg Benadryl at the time. She",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PVT,"Metformin, Diclonfec, Hydrochlorothiazide, Olemasarten, Fish Oil, Calcium Vitamin D, MVI",None,"Diabetes, Hypertension, Muscukolosketal Pain. Back Surgery, Hyperlipidemia",,"Levaquin, PCN, Floxin, Biaxin, Tramadol, Codeine and Hydrocortisone","['Dyspnoea', 'Speech disorder']",1,PFIZER\BIONTECH,IM 1050253,WA,57.0,F,"rash appeared on the 17th, started like a bug bite and then turned into a large rash to upper left arm on the 17th. then noticed a small round lump under left armpit. on 2-20-20 noticed a large lump under collar bone close to the shoulder, approx size of large egg.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2020,02/17/2020,13.0,OTH,"excedrin-generic, bio-fles",none,migraines,,staydol,"['Axillary mass', 'Injection site rash', 'Mass']",1,MODERNA,IM 1050255,WA,60.0,F,All over dermititis rash. Swelling in joints. accelerated heart rate. Dizzy. Weak.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/12/2021,1.0,UNK,Just vitamins,Infection in finger,None,,Allergic to pennicillins,"['Asthenia', 'Dermatitis', 'Dizziness', 'Heart rate increased', 'Joint swelling', 'Rash']",2,MODERNA,SYR 1050256,MD,85.0,M,"I am a four-year resident of facility and have never experienced a serious illness or traumatic injury in all of my adult life (I turn 86 this year). So on January 23rd I received my initial shot of the Moderna vaccine, for which I experienced no reaction, whatsoever. One month later I returned to hospital for my Moderna Booster shot on Saturday, February 20. I felt a few chills that evening, with nothing to speak about, but awoke on Sunday morning feeling so ill that I could barely sit up in bed. I borrowed my wife?s walker and managed to make it to and from the bathroom, and got back to bed again, whereupon I called my son, an emergency-room physician, who told me to take two Advil tablets (or its equivalent), and welcomed me to the club. I stayed in bed through the rest of Sunday and continued to sleep and rest throughout Monday morning, only feeling well enough to get out of bed without assistance by noon on Monday, thereby missing the February meeting of the monthly meeting that had been scheduled for that morning (and for which I had regularly been a member of and had attended every meeting for over three years). My personal takeaway from all this was that ?the cure was worse than the disease.?",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PVT,"HYDROCHLOROTHIAZIDE, CARDURA, AVADART, AVALIDE",NONE,"SPINAL STENOSIS , AORTA STENOSIS",,CLINDOMYACIN,"['Chills', 'Gait disturbance', 'Loss of personal independence in daily activities', 'Malaise']",2,MODERNA,SC 1050257,LA,74.0,F,"Patient had Moderna vaccination on 1/28/2021 and felt well that day and previous days. She woke up the next morning with altered mental status. low grade fever and confusion that improved within a few hours but did not resolve for at least 24 hours. She went to the Emergency Room at Hospital on 1/28/2021 and had labs, urine and CT of head that were all normal/no acute abnormality. Her symptoms resolved at about 24 hours or so and she has been well since. She was released from ER, not admitted.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/29/2021,1.0,PVT,amlodipine metformin gabapentin baclofen PrevPack Vitamin D 50.000 units weekly magnesium,HTN DM H. Pylori Chronic shoulder pain,HTN DM h/o Breast Cancer-remission 2020 Chronic shoulder pain COVID 19 in April 2020,,Ace inhibitors Statin,"['Computerised tomogram head normal', 'Confusional state', 'Full blood count normal', 'Laboratory test normal', 'Mental status changes', 'Metabolic function test normal', 'Pyrexia', 'SARS-CoV-2 test negative', 'Urine analysis normal']",UNK,MODERNA, 1050258,OR,69.0,F,Patient received boost moderna vaccine on 01/28/2021. Visited the ER on 2/21/2021 for cough and tested positive for COVID-19.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2020,02/21/2021,390.0,PVT,Mycophenalate mofetil 500mg- 2 tabs po BID PEG 400 0.4% PROP GLYCOL 0.3% OPH SOLN- 1 GTT BOTH EYES QID LOSARTAN 50MG - 1 TAB PO QD CALCIUM 500MG/VIT D 200U- TAKE 2 TABS PO BID FERROUS GLUCONATE 324 MG - 1 TAB PO QD LEVOTHRYOXINE NA 150MCG-,,Liver transplant disorder due to autoimmune hepatitis onset 10/07/2015 DM2 Sjogren Sydrome Hypothyroidism Osteoarthritis HTN Asthma,,Codeine- restlessness Lisinopril- cough,"['Cough', 'SARS-CoV-2 test positive']",2,MODERNA,IM 1050259,OR,28.0,F,"Fever, chills, tiredness, headache, body aches, sore lymph nodes, and nausea started approx 10 hours after shot. Took ibuprofen and acetaminophen for the duration of the symptoms Sunday night and all day Monday. By the time I woke up Tuesday morning (approx 42 hours after shot) the only remaining symptom was sore lymph nodes and more tired than usual.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,OTH,"Enbrel, aviane birth control pill, hydrocortisone, Pristiq, triamcinolone acetonide, vitamin D",None,"Arthritis, eczema, anxiety",,None,"['Chills', 'Fatigue', 'Headache', 'Lymph node pain', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1050260,TX,24.0,F,"symptoms started 10 minutes after vaccine given, left sided lower chest pain, with tingling to the left arm and shoulder , pressure to bilateral lower extremities , and left sided neck area. patient was alert and oriented x4 denies worsening in symptoms, vitals taken bp elevated a bit 154/98 , bp improved at 134/90 15 minutes later, patient stable, and alert with rn and provider in room.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PVT,Netalol 20 mg,,heart arrhythmia,,shellfish and iodine,"['Blood glucose', 'Blood pressure increased', 'Chest pain', 'Limb discomfort', 'Musculoskeletal discomfort', 'Paraesthesia']",1,MODERNA,IM 1050262,MN,68.0,F,"I got the shot at 10:30am. My arm was mildly painful at the injection sight. During the next early morning (~2:00am Friday, Feb 19) I had the chills for about 2 hours. I had intermittent muscle pain, nausea, and fatigue. These symptoms resolved during the day Friday, February 19th.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/19/2021,1.0,PVT,"prozac, buspiron, lanzoprazol, multivitamin, calcium, magnesium, krill oil, vitamin d",none,"depression, acid reflux",Pain at injection site with flu vaccine. Lasts about 8 hours then resolves.,"cephalexin, detrol","['Chills', 'Fatigue', 'Injection site pain', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH,IM 1050263,AZ,66.0,F,"Exactly a week after receiving the Pfizer vaccine I noticed a red rash on both of my ankles. Mostly the interior area of the ankle. There is also some mild swelling. No pain or itching. I have had no other symptoms since receiving this vaccine, not even a sore arm at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/22/2021,7.0,UNK,"Prilosec, Synthroid, Voltaren",none,"Hypothyroid, osteoarthritis",,Bextra,"['Rash', 'Swelling']",1,PFIZER\BIONTECH,IM 1050264,CA,69.0,F,"Approximately 10 days after vaccination, I experienced a severe Shingles outbreak. The worst Shingles outbreak I have ever had, while I had previously had Shingles approximately every 5-6 years for the past 45 years. The severity of this case was markedly different from any other Shingles outbreak I have ever had. Previously, I did have both the Varivax vaccination (approx 10 years ago) as well as two doses of the Shingrix vaccination (approx 3-4 years ago).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,02/08/2021,11.0,OTH,Calcium Vitamin D,None,Periodic Shingles for 45 years. Typically an outbreak approx every 5-6 years. No other health conditions.,,None,"['Condition aggravated', 'Herpes zoster']",UNK,MODERNA,SYR 1050265,AR,40.0,F,Joint pain Body aches Chills Fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/23/2021,1.0,PHM,"Cymbalta,estradiol,seroquel,pravastatin",,,,Sulfa,"['Arthralgia', 'Chills', 'Pain', 'Pyrexia']",2,MODERNA,IM 1050266,NY,65.0,F,"Immediately after getting the vaccine on February 19, I had prickling and burning in the top back of my head. I was sent to the emergency room where I was given an injection of Decadron and Pepcid and sent home with a prescription to take Prednisone for four days and Pepcid twice a day for 7 days. The prickling decreased a little but has returned with tingling in the face, feet, legs and arms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,PVT,"Levothyroxine, Low Dose Aspirin, Pepcid, Calcium, Magnesium, Vitamin B12, Vitamin C, Vitamin D, Zinc Carnosine, Vitamin K27, Immunotone, Liposomal Glutathione, Digestive Enzyme, Lauricidin, Tru Niagen, Probiotic, NAC, Ostinol, Mineral 360",None,"Hashimoto's Thyroiditis,Raynauds, GERD, Positive antibody to cardiolipin, history of cervical cancer in situ",,"Cipro, Keflex, Trimox, Sulfur, Bactrim, Macrodantin, Erythromycin","['Immediate post-injection reaction', 'Paraesthesia', 'Skin burning sensation']",2,MODERNA,IM 1050267,AK,36.0,F,Minor rash at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,OTH,Citilopram Hydroxyzine Pomate,,,,,['Injection site rash'],1,MODERNA,IM 1050268,IL,40.0,F,"Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (patient states vitals elevated from normal); shaking, dizzy, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,SCH,None,None,No,,Nuts - Cashews & Pistachios,"['Chest discomfort', 'Dizziness', 'Nausea', 'Palpitations', 'Taste disorder', 'Tremor']",1,PFIZER\BIONTECH,IM 1050269,IA,32.0,F,"The evening after obtaining the covid vaccine, I started experiencing mild tingling and numbness to my left arm, left leg, and left side of my mouth and cheek. The left side if where I received my injection. The numbness and tingling resolved after the first day to my arm and leg, but has continues around the left side if my upper lip. The sensation is only intermittent and can last a few hours. No treatments have been tried.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,PVT,levothyroxine,None,subclinical hypothyroidism,,None,"['Hypoaesthesia', 'Paraesthesia', 'Paraesthesia oral']",UNK,PFIZER\BIONTECH,SYR 1050271,IA,50.0,F,"pt reported chills, fever, labored breathing, palpitations, chest pressure starting 12 hrs after her dose and lasting 2 hrs. No treatment needed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/24/2021,1.0,PVT,"escitalopram, probiotic, Yoli, vit D, Magnesium","had likely covid 19, onset of sxms 11-30-20, tested negative 12-14-20. Entire family had it.",migraine,,codeine,"['Chest discomfort', 'Chills', 'Dyspnoea', 'Palpitations', 'Pyrexia']",1,MODERNA, 1050272,ND,77.0,M,Pt presented on 2/22/21 reporting right sharp and stinging arm and shoulder pain for 3-4 days. Pain was worse with touch/pressure. On 2/21/21 he developed a lesion on his shoulder. Provider found 2 vesicular lesions concerning for shingles. She started pt on gabapentin an valcyclovir and will follow up as needed.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/09/2021,02/18/2021,9.0,PVT,"atorvastatin, losartan, metformin, methotrexate, plavix, vitamin d, zyrtec",,"hyperlipidemia, hypertension, type 2 diabetes, history of CVA",,"amoxicillin, penicillin varenicline","['Arthralgia', 'Pain', 'Pain in extremity', 'Rash vesicular', 'Skin lesion']",1,MODERNA, 1050273,IL,42.0,F,Swollen red rash that is growing on my arm. Stemming from injection site. The rash is also hot to the touch,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/01/2021,,PHM,,,,,"Penicillin, Biaxin, Sulphatez","['Injection site erythema', 'Injection site rash', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 1050274,CA,30.0,F,"Immediate experience of hot flushes and chills with severe nausea. Chest felt tight, upper stomach in extreme discomfort, Hard to see, lights hurting eyes, seeing spots in the air. Sound became amplified and began to experience a migraine. ""People talking low to me felt like they were screaming into my ear drums."" Extreme fatigue so could barely keep eyes open. Standing was difficult; moved to wheelchair. Most symptoms lasted 2 to 3 days. Fever of 102 on first day only. Fatigue for one week. Right upper arm, not at the injection site, had a ""hive"" about the size of a nickel that has not gone away (as of 2/23/21). New migraines with light sensitivity that affect ability to work also have not gone away (as of 2/23/21).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,PVT,,,,,,"['Abdominal discomfort', 'Chest discomfort', 'Chills', 'Dysstasia', 'Fatigue', 'Hot flush', 'Hyperacusis', 'Migraine', 'Nausea', 'Photophobia', 'Pyrexia', 'Urticaria', 'Visual impairment']",2,MODERNA,IM 1050275,AZ,67.0,F,Complaint: Nausea approximately 5 minutes after COVID vaccine administration. Treatment: None. Observed 30 minutes. Symptoms subsided,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,PUB,Unknown,Unknown,Unknown,,NKDA,['Nausea'],1,MODERNA,IM 1050276,WA,66.0,F,"Injection site pain, tiredness, headache, muscle pain up and down Rt side of body from neck to feet, itchy rash all over torso, heart palpitations and pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/14/2021,2.0,PVT,"Vitamin C, zinc, D3 , K2, multivitamin",,Herpes Zoster Virus,,,"['Angina pectoris', 'Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Palpitations', 'Rash pruritic']",1,PFIZER\BIONTECH,SYR 1050277,AL,70.0,F,"When I left facility I had a mild headache. After getting on the highway face turned beet red with mild swelling. Throat felt tight but not closed. An hour later the headache was worse. Took a Tylenol and slept for an hour. Woke up itchy. Glands on right side of neck very sore with pain radiating to base of skull. Swelling in face subsided after a few hours. Later at night I was still itchy with some small red hives on my arms, legs, and stomach. Arm very sore. Woke several times during the night with nausea. Woke up morning of the 20th with mild dizziness, upset stomach and severe diarrhea, Serious headache all day. Hives subsided but was still itchy. On the 21st felt much better but still with diarrhea. Today is the 23rd and no diarrhea since this morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,UNK,Atenolol 50 mg; Levothyroxine 100 mcg; vitamin,,Lyme Disease; Mild HBP; Hypothyroid,,Penicillin; Keflex; Norvasc; Levaquin; Erythromycin,"['Abdominal discomfort', 'Diarrhoea', 'Dizziness', 'Erythema', 'Headache', 'Lymph node pain', 'Nausea', 'Pain', 'Pain in extremity', 'Pain of skin', 'Pruritus', 'Sleep disorder', 'Swelling face', 'Throat tightness', 'Urticaria']",UNK,PFIZER\BIONTECH,IM 1050278,FL,54.0,M,"Patients daughter called to inform us that her fathers arm became very swollen and red the day after vaccine administration. She also stated that although the patient was not in excruciating pain, the patient did express discomfort and a burning sensation on the arm. Patient contacted his doctor and followed prescribers instructions for treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/14/2021,1.0,PHM,,,,,NKDA,"['Burning sensation', 'Erythema', 'Limb discomfort', 'Peripheral swelling']",1,MODERNA,IM 1050279,VA,44.0,F,"Severe bruising with pain in left arm, armpit, and left breast/chest. Pain, fever of 102 for 24hrs. Temperature after 24hrs was 99-100. Tylenol used to help control temperature. Now with painful fluid filled pustules, rash on right buttocks.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/21/2021,4.0,OTH,None,None,None,,Be stings,"['Axillary pain', 'Breast pain', 'Contusion', 'Pain in extremity', 'Pustule', 'Pyrexia', 'Rash']",2,MODERNA,IM 1050280,HI,39.0,M,"Aching body, mild headache, and feeling warm to the touch. Feeling of fatigue, tired, and generally lacking in energy. Difficult to conduct normal work duties. Feeling of tired and fatigue lasted for two days after vaccine. mild soreness at injection site, nothing debilitating.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/19/2021,1.0,MIL,None,None,None,,None,"['Fatigue', 'Feeling hot', 'Headache', 'Injection site pain', 'Pain']",2,PFIZER\BIONTECH,IM 1050281,CA,66.0,M,"Per family, patient has been feeling sick since he was vaccinated, patient went to ER on 02/15/2021, and after few hours at ER patient passed away.",Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/01/2021,,PVT,"Aspirin 81 MG Tablet Delayed Release, 1 Tablet Orally once a day Norvasc 10 MGTtablet, 1 Tablet orally once a day Lisinopril 20 MG Tablet, 1 Tablet orally once a day Terazosin HCl 10 MG tablet, 1 tablet orally once a day Metformin HCl 1000",,"Z86.39 History of vitamin D deficiency Z99.89 Uses continuous positive airway pressure (CAPAP) ventilation at home E11.40 Type 2 diabetes mellitus with diabetic neuropathy, without long-term current use of insulin I10 HTN (hypertension) N40.0 BPH (benign prostatic hyperplasia E11.29 Microalbuminuria due to type 2 diabetes mellitus Z87.09 Hx of emphysema G47.33 Severe obstructive sleep apnea G47.30 Sleep apnea H25.13 Age-related nuclear cataract, bilateral Z68.36 BMI 36.0-36.9, adult I83.813 Varicose veins of both lower extremities with pain E00.36 Type 2 diabetes mellitus with diabetic cataract, without long-term current use of insulin",,,"['COVID-19 pneumonia', 'Cardiac arrest', 'Death', 'Malaise', 'X-ray abnormal']",1,MODERNA,IM 1050282,LA,32.0,F,Heat and redness around entire upper left arm for about 4 days. Intense itchiness that was relieved with antihistamines that lasted for about 7 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/02/2021,1.0,PVT,"Buproprion, Desfenlafaxine, Alprazolam, Zolpidem",None,None,,None,"['Erythema', 'Feeling hot', 'Pruritus']",2,MODERNA,IM 1050285,CA,71.0,F,"erythematous, pruritc localized reaction on upper arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/18/2021,10.0,UNK,,,,,,"['Pruritus', 'Rash erythematous']",1,MODERNA,IM 1050287,WA,81.0,F,"Partial deafness, right ear, noted two days after the vaccine was administered. A ten-day course of Prednisone begun, and hearing PARTIALLY returned two days later. Unknown if the inflammatory reaction expected of the Moderna vaccine caused the deafness. Also unknown if the the dosage of Prednisone reduced the effectiveness of the vaccine. (My history of Meniere's disease does cloud the issue, but I decided to report the inflammatory response to the vaccine as likely relevant.)",Not Reported,,Not Reported,Not Reported,,Yes,U,01/21/2021,01/23/2021,2.0,PVT,"Thyroid replacement: ? l-thyroxine 135 mm per day, AM before meal ? Liothyronine (Cytomel) 12.5 MCG AM (half a 25 MCG tablet) AM before meal ? Calcitrol - .25 MCG - (for parathyroid disease) ? Allopurinol - 300 MG -1 tabs per day (for",,"Meniere's disease (vertigo, deafness), heart attack and heart failure, one kidney,",,"Aspirin, Demerol, Metoprolol, Macrobid .... soy, black pepper, walnuts","['Blood glucose increased', 'Blood test abnormal', 'Condition aggravated', 'Deafness transitory', 'Inflammation']",1,MODERNA,IM 1050288,NY,29.0,F,"Pt transferred to observation area for 15 min. At 2:19 for discharge I noticed pt having some difficulty breathing. Pt then started to have sensation of throat closing and chest tightness. Pt stated she is allergic to shellfish, peanuts, seasonal and anesthesia. Blood pressure was 136/86-HR-100 O2 saturation 99%. AOx3 no change in mental status, stridor or wheezing noted. No N/V or abdominal pain. No dizziness or hypotension. No hives, swelling of lips, tingling, or itching noted. Pt took her own medication of Qvar80mcg-Redinhaler @2:30pm. Stiolto Respimat inhaler 2.5mcg. @2:35pm. Also has albuterol/ EPI pen, but didn't take it. Pt given Benadryl 50mg 2:40pm with water. Patient symptoms resolved completely by 3:45pm. Continued to monitor pt. Pt states she is feeling better no signs or symptoms of distress noted. Pt verbalize understanding of follow up with PMD and allergist@ Allergy and Sinus before coming for second dose. Pt taking taxi home husband was notified.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PUB,Qvar 80mcg Redinhaler-taken after vaccine Stiolto Respimat 2.5mcg -taken after vaccine Albuterol sulfate HFA 90 mcg- taken in AM before vaccine Allegra 180 mg taken in am before vaccine Ortho Novum 1/35 Adderall 10mg unknown if taken that,All allergies listed above. Asthma and anxiety,"Seasonal allergies, asthma, severe allergic reactions as listed above.","Possible hives, rash, throat constriction to vaccination. Unknown age or vaccine type","Peanuts, shell fish, seasonal allergies, grass, pollen extract, ragweed, house dust mites, cat dander, latex, laundry detergent , shampoo and conditioners.","['Chest discomfort', 'Dyspnoea', 'Throat tightness']",1,MODERNA,IM 1050289,NV,59.0,M,"2 days later developed chest tightness, left arm pain, weakness, HTN",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/21/2021,2.0,PVT,,,,,,"['Asthenia', 'Chest discomfort', 'Hypertension', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 1050290,MI,53.0,F,Constipation/hemorrhoids bleeding and Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/21/2021,1.0,PUB,"Novolog, hydrochlorothiazide, Vitamin D, Metformin, Loratadine, Losartan and Rosuvastatin",None,Diabetes,,Lipspril,"['Constipation', 'Fatigue', 'Haemorrhoids', 'Rectal haemorrhage']",1,MODERNA, 1050298,NV,73.0,F,Patient states she woke up at her usual time and on the way to the kitchen blacked out. She woke up and crawled to the kitchen then blacked out and and peed herself.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/20/2021,02/21/2021,1.0,PUB,,,,,,"['Loss of consciousness', 'Urinary incontinence']",2,MODERNA,IM 1050303,IL,73.0,F,"Left shoulder still sore in the clavicle area above the shoulder from the first Moderna dose, 28 days later. Patient ranked the soreness at a level of 2 to 3 on a scale of 1 to 10 with 10 being the worst pain ever and 1 being the least pain. Pharmacist will notify Dr and has advised patient to do so.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/25/2021,1.0,PHM,Synthroid,unknown,thyroid removed,,"Meloxicam- severe allergic reaction with dyspnea; Dilaudid - dyspnea; Penicillin - hives, rash",['Injection site pain'],1,MODERNA,IM 1050305,NY,70.0,F,Patient reports itchy inflammation appearing around injection site beginning 2/18/21 and persisting through today (2/23/21). Patient states rash to be approximately 4 inches wide and 6-7 inches long located entirely on vaccination arm. Patients symptoms have not worsened or improved since started.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/18/2021,8.0,PHM,unknown,none,none,,none,"['Injection site inflammation', 'Injection site pruritus', 'Rash']",1,MODERNA,IM 1050306,OH,70.0,F,"red, warm to touch around injection site area. Started on Sunday and keeps growing. doesn't hurt or itch but is warm to touch. pt has used alcohol and hydrocortisone",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/21/2021,2.0,PHM,,,,,,"['Injection site erythema', 'Injection site warmth']",2,MODERNA,IM 1050308,AZ,71.0,F,"Moderna - 19 Vaccine EUA - tender, itching and inflammation in an oval 3 - 4 inches around injection site. Covid Arm ?",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/21/2021,9.0,OTH,"Atorvastatin 40 mg daily, Levothyroxine 100 units daily, multivitamin daily, Lutein 20 mg, CoQ10 200, Preservision capsule daily, Mg 250 mg daily, ASA 81 mg daily, Vitamin D 5000 IU daily, Fish Oil 1400 daily",None,"Hypothyroid, CAD",,"PCN sulfa, Ibuprofen","['Injection site inflammation', 'Injection site pain', 'Injection site pruritus']",1,PFIZER\BIONTECH,SYR 1050309,CA,64.0,F,"I had my 2nd dose of covid vaccine on 1/15, around 5 pm. Next day when I got up about 7:20 I felt dizzy nausea and wanted to vomit. Then I passed out, I fell down and hit my face on the floor. My family called 911 paramedica. They ,measured d my blood pressure and it was too low. The area around my right eyebrow was swollen and my neck hurt as precaution I went to the hospital. I suspect the incident and its symptom are side effects of the vaccine given the timing. Later on I had headache off and on and brain fog.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/16/2021,1.0,OTH,"loratadine, simvastatin",none,"High cholesterol, seasonal allergies.",,"Seasonal Allergies, nkda, no food allergies, not allergic to anything else known.","['Computerised tomogram normal', 'Dizziness', 'Electrocardiogram', 'Fall', 'Feeling abnormal', 'Headache', 'Nausea', 'Neck pain', 'Skin laceration', 'Swelling face', 'Vomiting', 'X-ray']",2,PFIZER\BIONTECH,IM 1050315,CA,60.0,F,"I had a response to the vaccine approximately 16 hours after the injection of chills, myalgias and headache, however 24 hours after injection my clavicular lymph nodes became enlarged and tender.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/21/2021,2.0,PVT,None,None,Psoriasis,,NKDA,"['Chills', 'Headache', 'Lymphadenopathy', 'Myalgia']",UNK,MODERNA, 1050322,NY,46.0,F,"Severe hives outbreak. Hives began on legs about 18 hours after second dose shot. After about 4 hours, all limbs covered in hives and throat felt irritated. Took a 5mg Claritin at that point (fearing hives would worsen during night). Awoke with no reaction next day or thereafter. No hives reaction after first dose. After both doses had typical sore arm for 48 hours; fatigue after second dose only.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,MIL,"Nutrafol, collagen peptides (Vital Proteins), vitamin D",None,None,,None known,"['Fatigue', 'Pain in extremity', 'Throat irritation', 'Urticaria']",2,PFIZER\BIONTECH,IM 1050324,FL,68.0,F,Chills & body aches Chills lasted about 8 hours Aches lasted 3 days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,OTH,"Plavix Atorvastatin Atenolol Glucosamine Famodidine Vitamins C ,D, & B12 Ceterizine Montelukast Andrew Lassman Night Time capsules - herbal",None,None,67 flu & pneumonia,None,"['Chills', 'Pain']",2,PFIZER\BIONTECH,SYR 1050327,GA,70.0,F,Positive covid test on 2/22/2021. Symptoms began about 2/19/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/19/2021,17.0,PVT,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1050341,IL,44.0,F,Sore arm at injection site and fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PUB,None,None,None,Flu,None,"['Fatigue', 'Injection site pain']",2,PFIZER\BIONTECH, 1050346,TN,59.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/23/2021,6.0,UNK,"Levothyroxine, carvedilol, vit d3, magnesium, soma, hydrocodone",No,"Copd, lymphedema, under active thyroid, graves eye",,I don?t remember the names,['Unevaluable event'],1,MODERNA,SYR 1050351,FL,68.0,F,A itchy rash appeared around the injection site a week after the injection. The area felt warm to the touch and itchy. Treated with oral antihistamine (Benadryl) and application of cortisone cream.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/20/2021,7.0,PHM,"Elmiron 100mg 2Xdaily, Multivitamin, Vitamin D 1,000 IU, Citracal 1200 slow release plus D",None,"Interstitial Cystitis, IBS",Rash immediately following pneumonia vaccine.,None known,"['Injection site pruritus', 'Injection site rash', 'Injection site warmth']",1,MODERNA,SYR 1050356,CA,21.0,F,"21 yo female return from 2nd dose , c/o SOB , Flushed, foggy brain. 1608 BP- 128/88, SPO2- 98, P-87, R-18 Administered 50 mg Benadryl, pt began to feel increased dizziness, lowered patient to the floor and administered 6L of O2. doctor assessed patient, patient Alert and Oriented X3 lowered O2 level to 2L, Sat patient up in chair @1623 BP-146/98, SpO2-98, P-83, R-20. Pt sated she felt better and was released to aunt @ 1627.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PUB,Allegra,na,na,"SOB, itchy throat, dizziness","eggs, sulfur","['Dizziness', 'Dyspnoea', 'Feeling abnormal', 'Flushing']",2,PFIZER\BIONTECH,IM 1050364,NY,24.0,F,Fever 100 for one day and half,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/22/2021,1.0,SCH,Vitamin C Vitamin Omega Rampril,,glomerulosclerosis,Fever flu vaccine,,['Pyrexia'],2,MODERNA,SYR 1050368,CO,81.0,F,"Patient presented with three weeks of progressive back pain and bilateral lower extremity radiculopathy, associated with night sweats (no fevers, no leukocytosis), found to have extensive T9-S1 spinal epidural abscess due to MSSA. Symptoms started at around the time the patient received her first COVID-19 vaccination on 1/26/2021. No other obvious source of infection (she does have an ear wound but this did not appear infected). She was admitted to the Hospital on 2/17/2021. Adverse event reported on 2/23/2021. She remains hospitalized as of this report.",Not Reported,,Yes,Yes,6.0,Not Reported,Y,01/26/2021,02/17/2021,22.0,PVT,"APAP 500-1000 TID PRN, ferrous sulfate daily, Xanax 0.25 mg BID PRN, amlodipine 5 mg qhs, Eliquis 5 mg bid, Lipitor 40 mg qd, Citalopram10 mg qd, HCTZ 12.5 mg daily, Norco 5-325 1-2 tabs BID PRN, Synthroid 175 mcg daily, Losartan 50 mg dail",,"Prior CVA in 2018, Primary hypertension, atrial fibrillation, chronic sinusitis, hypothyroidism",,Bactrim,"['Back pain', 'Culture wound positive', 'Ear injury', 'Extradural abscess', 'Hyperhidrosis', 'Magnetic resonance imaging neck', 'Magnetic resonance imaging spinal abnormal', 'Magnetic resonance imaging thoracic abnormal', 'Night sweats', 'Radiculopathy', 'Staphylococcal sepsis']",1,MODERNA,IM 1050379,,77.0,M,"More than 20 minutes after vaccination, but within 24 hours, patient experienced throat restriction. He was hospitalized.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/26/2021,01/27/2021,1.0,PHM,,,,,,['Throat tightness'],1,MODERNA,IM 1050390,VA,41.0,F,"Patient has a rash all over her body. Though, it appears in clusters. They are itchy. Has lasted 3 days without improvement",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/20/2021,1.0,PHM,multivitamin,none.,none.,,peanuts,['Rash'],1,PFIZER\BIONTECH,IM 1050401,CA,43.0,F,"Had 1st dose 12/18/20, had 2nd dose 1/8/21. On 1/15/21 noticed right cervical lymph node swollen >5cm. After 3 biopsies , diagnosed with non Hodgkin's lymphoma 2/11/21",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/15/2021,7.0,OTH,Flonase Alvesco Metformin Benefiber,None,DM2,,None,"['Biopsy', 'Lymphadenopathy']",2,PFIZER\BIONTECH,IM 1050407,CA,73.0,F,My mother passed away sometime in the night or this morning. I talked to her at 6:30 yesterday and she was gone this morning. She was covered in what looked like a rash of some kind and her toung was enlarged. They did say the evening she had a flushed face and her tongue seemed enlarged or swollen.,Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/23/2021,1.0,SEN,,,"Diabetes Type II, Clogged arteries",,none,"['Death', 'Flushing', 'Rash', 'Swollen tongue']",2,UNKNOWN MANUFACTURER, 1050408,OH,70.0,F,"The patient began to have hot flashes and some dizziness. She felt ""disoriented in her eyes,"" while also having a slight headache. The feeling went away after 10 minutes and began 15 minutes after receiving her second Pfizer vaccine dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,SCH,,,,,,"['Dizziness', 'Headache', 'Hot flush', 'Metamorphopsia']",2,PFIZER\BIONTECH,IM 1050431,FL,80.0,M,"Since I was not with my husband I can only tell you what was told to me. He walked out of the store toward our car. Someone watched him, concerned, because he was walking very slowly (normally has a slow gait because of leg braces and toe amputations so I don't know if it was unusually slow). The woman saw him fall and she ran to help-administered CPR immediately-and told me he died instantly. Medics tried to resuscitate and failed to bring a pulse. (My husband left our home around 11:15 to drop a package off at store. The store is one mile from our home. At around 12:30 a deputy came to my door and when I saw him my knees buckled. I knew something horrible happened.",Yes,02/02/2021,Not Reported,Not Reported,,Not Reported,N,01/26/2021,02/02/2021,7.0,PHM,To the best of my knowledge these are the drugs he took that morning. Furosemide 20 mg; Isosorbide Mononitrate-ER 60 mg; Calcitrol .25 mcg; Levothyroxine - .15 mg; Folic Acid 800 mcg; MultiVits; Metamucil 525 mg capsule; Metroprolol ER -,None,"Heart disease, diabetes in the past but not for the past 4 years; had 3 toe amputations; poor circulation in his legs.",,None,"['Bradykinesia', 'Fall', 'Pulse absent', 'Resuscitation', 'Sudden death']",1,MODERNA,SYR 1050441,VA,86.0,M,"Vaccination and observation period successfully completed without adverse event. The patient's significant other reported neither of them were feeling well on 2/21/2021. Approximately 28 hours after vaccination, the patient was found unresponsive in the bathtub. EMS arrived within 5 minutes, resuscitation attempt was unsuccessful, CPR terminated at 1503 and the patient pronounced dead. The Medical examiner refused the case on the basis of lack of jurisdiction, and the remains were moved to a local funeral home. No autopsy was performed. This event is not thought to be related to the vaccination event or the vaccine, the death is thought to be from natural causes.",Yes,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,OTH,"reported ""Zelcor"", may have meant Zocor",None reported,None reported,,None reported,"['Death', 'Malaise', 'Resuscitation', 'Unresponsive to stimuli']",2,MODERNA,IM 1050442,PA,52.0,F,"Patient is a 52 year old female who presents with concerns of headaches, nausea, fatigue, hives/itching, and SOB since receiving her Covid-19 vaccine 3 weeks ago. Got the Pfizer vaccine at the Center on 1/17/21 around 12:30PM. She had no side effects during the 15 minutes she was kept for observation after receiving the vaccine. She did develop a headache and fatigue approximately 1.5 hours after she got the vaccine and then later that day developed nausea. SOB developed the following day. She developed hives on her chest approximately 2-3 days after the vaccine. States she cannot recall the exact date that the hives started. Hives have appeared like pink raised plaques. Largest plaque was 1 inch in diameter she estimates. The hives have continued to come and go from different areas of her body including her shoulders, buttock, upper legs. SOB is present at rest and with exertion. She has had no chest pain/pressure/tightness/wheezing , palpitations, or feeling of her throat closing. States her exertion capacity is reduced.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,PVT,"albuterol sulfate (VENTOLIN HFA) 90 mcg/actuation inhl inhaler ASHWAGANDHA ROOT EXTRACT,BULK, MISC aspirin EC (ASPIRIN LOW DOSE) 81 mg oral delayed-release busPIRone (BUSPAR) 10 mg oral tablet CA CITRATE/MGOX/VIT D3/B6/MIN (CALCIUM CI",,Meniere's disease Osteopenia Hx of TIA Moderate persistent asthma IBS-C GERD Migraines,,"Ceclor [Cefaclor] Latex Penicillins Sulfa (sulfonamide Antibiotics) Tape 1""x5yd [Adhesive Tape]","['Dyspnoea', 'Fatigue', 'Headache', 'Nausea', 'Pruritus', 'Urticaria']",UNK,PFIZER\BIONTECH,IM 1050446,HI,44.0,M,"Patient had recieved vaccine and was walking toward the waiting area in the bleachers. He began to feel dizzy and light headed. He syncopized and struck his head on a concrete stair. He was immediately seen by provider who was at a nearby table. The patient regained consciousness within moments without any evidence of post ictal confusion. He suffered a laceration to the head. Bleeding was controlled, EMS was contacted expiditiously, and the patient ambulated from the building approximatelyh 20 minutes later and was brought by EMS to the nearest emergency department to be evaluated.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,02/09/2021,0.0,MIL,None,None,None,,None,"['Dizziness', 'Head injury', 'Loss of consciousness', 'Postictal state', 'Skin laceration', 'Syncope', 'Wound haemorrhage']",1,PFIZER\BIONTECH,IM 1050450,NV,77.0,F,"Patient was given a vaccine without a written consent, without knowledge of her medical conditions or allergies. She had already received 2 Covid vaccines and the vaccinator gave her a 3rd dose.",Not Reported,,Not Reported,Not Reported,,Yes,U,02/16/2021,02/17/2021,1.0,SEN,,,,,,['Extra dose administered'],3,PFIZER\BIONTECH,IM 1050462,WV,49.0,M,Developed Shingles on the right side of my head,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/10/2021,5.0,PUB,"Fish oil, blood pressure, multi vitamin, low dose aspirin",None,High Blood pressure,,None,['Herpes zoster'],UNK,PFIZER\BIONTECH, 1050471,NM,43.0,F,"Within two hours of injection, headache and fever symptoms with body aches for appoximately 56 hours. Approximately 40 hours after injection, noticable drooping of right side of face, which resolved 90% after 24 hours; doctor assessment was that this was likely a temporary case of Bell's Palsy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,PUB,Escitalopram (10 mg/ daily),None,None,"Following Yellow Fever vaccine in 1993, patient experienced extreme swelling and darkening of the arm, which fully resolved wit","Penicillin, Claritin-D (pseudoephedrine sulfate)","[""Bell's palsy"", 'Facial paralysis', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 1050476,UT,31.0,F,"Fetal demise at gestational age 14 weeks. Exact age when patient received first dose of COVID-19 vaccine. Patient had suffered from hyperemesis prior to vaccine, but had improved prior to vaccine. No other complications in pregnancy estimated date of delivery was July 14, 2021",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,12/30/2020,02/08/2021,40.0,WRK,,,,,,"['Cytogenetic analysis normal', 'Exposure during pregnancy', 'Foetal death']",1,PFIZER\BIONTECH,IM 1050485,AK,33.0,F,"Patient presented at 5:05 with complaints of burning sensation in chest, tachycardia, throat irritation and itching, mild cough, flushing of chest and face. No SOB. Pulse 120. O2 sat 99%. BP 110/70. She had a history of serious allergic reactions to foods in the past, and was familiar with the symptoms. She was provided a 25mg dose of diphenhydramine (she had previously taken 25mg prior to her vaccine, in addition to her daily allergy medication in the morning) and she was observed. over a 30 min observation period her pulse came down to under 100, her flushing and throat irritation resolved. She was feeling back to baseline and she was allowed to leave.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/23/2021,02/23/2021,0.0,OTH,,,,,multiple food allergies,"['Chest pain', 'Cough', 'Flushing', 'Tachycardia', 'Throat irritation']",2,PFIZER\BIONTECH,IM 1050499,CA,66.0,F,"Hives, urticaria within 5 minutes of administration. Treated with antihistamines. Good results.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PVT,acetaminophen prn and albuterol prn,non,"GERD, asthma",,"azithromycin, clindamycin, penicillin, erythromycin, tetracycline, proparacaine","['Tryptase', 'Urticaria']",1,PFIZER\BIONTECH,IM 1050503,MN,80.0,M,Severe thrombocytopenia. Administration of dexamethasone and IVIG immune globulin. Petechiae over bilateral lower extremities and feet. Ecchymosis.,Not Reported,,Not Reported,Yes,,Not Reported,N,02/09/2021,02/16/2021,7.0,PVT,APAP 650mg PO Q4H PRN Allopurinol 300mg PO daily Amlodipine 5mg PO daily Amoxicillin 2000mg prior to dental appointment Dulcolax 5mg PO PRN daily MVI PO daily Prilosec 20mg PO daily,None,"Constipation, diverticulitis, GERD, gout, HTN, CKD stage 3, sleep apnea",,"Codeine, lisinopril","['Ecchymosis', 'Immunoglobulin therapy', 'Petechiae', 'Thrombocytopenia']",1,PFIZER\BIONTECH,IM 1051502,PA,33.0,F,"Approx 6 weeks at time of second administration with a due date of sept 28th. Would have been 3 weeks pregnant at time of 1st injection. 3 days after second injection, I began to miscarry. This was confirmed by declining HCG levels. Ultrasound to follow in one week.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/15/2021,3.0,PVT,Prenatal vitamins,None,None,,None,"['Abortion spontaneous', 'Exposure during pregnancy', 'Human chorionic gonadotropin decreased']",2,PFIZER\BIONTECH,IM 1050989,CA,30.0,M,"Fever of 101 degrees F that is on and off/100.7 F; Wasn't not able to swallow or eat at all; Severe red sore throat with white points; Very sweaty especially at night; a little bit of delirious; Severe chills where his teeth were chattering; Sore throat/In agony with a sore throat; Sore arm; When he first got the vaccine he said ""Boy you can really feel something going on in there""; A spontaneous report was received from a consumer regarding her son, a 30-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a little bit delirious/delirious, sore throat, sore arm/vaccination site pain, chills, fever/pyrexia, when first receiving the vaccine he stated ""boy you can really feel something going on in there""/ vaccination site dysathesia, swallowing difficult/dysphagia, severe red sore throat with white points/throat infection, and very sweaty at night/night sweats. The patient's medical history was not included. Products known to have been used by the patient were Vitamin D3, Creatine monohydrate and Fish Oil. On 11 January 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 12 January 2021, the patient reported a sore throat, and sore arm, took 2 ibuprofen, which patient reported as helped. On 14 January 2021, the patient reported chills, sore throat in agony with sore throat, and fever. Patient took ibuprofen, which he reported as helping and was able to sleep. The soreness in the arm was reported as gone. On 17 January 2021, the patient's mother reported he was still having fever and was a little bit delirious. On 18 January 2021, the patient reported fever, sweaty at night, severe red sore throat with white points, unable to eat or swallow. Treatment information included ibuprofen every 6 hours, which was reported to not be helping. Consent to contact was provided. Action taken with mRNA-1273 was not reported. The outcome of the event, sore arm, was considered unresolved. The outcome of the events, sore throat, fever, sweaty at night, severe red sore throat with white points, being unable to eat or swallow, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events , a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,UNK,VITAMIN D3; CREATINE MONOHYDRATE; FISH OIL,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Body temperature', 'Chills', 'Delirium', 'Dysphagia', 'Night sweats', 'Oropharyngeal pain', 'Pharyngitis', 'Pyrexia', 'Vaccination site dysaesthesia', 'Vaccination site pain']",1,MODERNA,OT 1050990,GA,,U,"Multiple doses were administered out of vials that had been punctured for more than 6 hours; A spontaneous report was received from a physician concerning approximately 50 patients who received Moderna's COVID-19 vaccine (mRNA-1273) administered from vials that had been punctured more than 6 hours. The patients' medical history was not provided. Concomitant product use was not provided by the reporter. Between 24 Dec 2020 and 08 Feb 2021, patients received their first of two planned doses of mRNA-1273 (Batch number 026L20A and 027L20A) intramuscularly for prophylaxis of COVID-19 infection. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided/unknown. The event, vaccine administered from vials that had been punctured more than 6 hours, was considered resolved on 08 Feb 2021. Treatment, action taken with RNA-1273 in response to the event and the outcome of the event were unknown; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273, batch number 027L20A. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,12/24/2020,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Expired product administered'],1,MODERNA,OT 1050991,NY,,F,"Few drops of the dose dripped out as the nurse was administering; vaccine pen was faulty; Received another dose as a result; A spontaneous report was received from a health care professional, concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported the patient had received the product and a few drops of the dose dripped out during administration and subsequently received another dose with no associated adverse events. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04-FEB-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number:004M20A ) for prophylaxis of COVID-19 infection. On 04-FEB-2021, during vaccine administration, the vaccine pen was faulty and a few drops of the dose dripped out as the nurse was administering. The patient received another dose as a result. There was no reported adverse events with the product administration error. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, few drops of the dose dripped out as the nurse was administering and received another dose as a result, was considered resolved.; Reporter's Comments: This report refers to a case of vaccine underdose, syringe issue, and extra dose administered for mRNA-1273, lot # 004M20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,02/04/2021,28.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no medical history reported),,,"['Extra dose administered', 'Syringe issue', 'Underdose']",1,MODERNA,OT 1050992,MA,,F,"Peripheral neuropathy, tingling in arms and feet; Burning sensation in legs; Could not sleep well; Swellng in lymph node on right side; Sore Arm; Fatigue; Chills; Body Aches; Debilitating; A spontaneous report received from Healthcare Professional concerning, 40-year-old female patient who received dose of Moderna COVID-19 vaccine experienced sore arm, fatigue, chills, and body aches. /MedDRA PT: [Sore Arm] The patient's medical history was not included. Patient's concomitant was not included. On 05-JAN-2021 date, the patient received their first dose of the two planned doses of mRNA-1273 in right arm (Batch #: 011J20A) intramuscularly for prophylaxis of COVID-19 infection. Patient who is a Pharmacist received the 1st Moderna vaccine on 05Jan2021 in her right upper arm. Patient stated initially she had a sore arm, fatigue, chills, and body aches. Patient stated 5 days later she had redness and swelling in her lymph node on her right side. Patient stated 10 days later she had peripheral neuropathy and tingling in arms and feet. Patient stated she then developed a burning sensation in her legs. Patient stated that the MD did a full workup on her. Patient stated that all tests came back negative. Patient stated that the MD gave her gabapentin. Patient stated she could not sleep well due to tingling sensation and pain. Patient would like to know if this has been reported. Patient stated today she feels fine. Patient stated this was a scary episode for her and 1st dose of the Moderna COVID-19 vaccine was very debilitating. Patient stated that she has not received the 2nd dose and does not want to receive the 2nd dose of the Moderna COVID 19 vaccine. Patient was treated with Gabapentin by an MD. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported event, a causal relationship cannot be excluded. Chills fatigue and lymphadenopathy are consistent with the known safety profile of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,GABAPENTIN,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,"['Asthenia', 'Burning sensation', 'Chills', 'Fatigue', 'Lymphadenopathy', 'Neuropathy peripheral', 'Pain', 'Pain in extremity', 'Poor quality sleep']",1,MODERNA,OT 1050993,OH,,F,"right leg had been paralyzed; nerve sensation in leg was gone; leg pain; leg was stiff; unable to walk; was in bed for three days unable to get up; lost muscle ability of leg; lower leg looked purplish; right quad was reddened and inflamed; did not have strength in legs; felt weak; right quad was reddened and inflamed; knee was swollen, warm to touch and looked inflamed; sharp electrical shocks in knee; A spontaneous report was received from a consumer concerning a 76-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced right leg had been paralyzed, sharp electrical shocks in knee, right quad was reddened, right quad was inflamed, knee was swollen, knee was warm to touch, knee was inflamed, leg looked purplish, did not have strength in legs, felt weak, lost muscle ability of leg, leg pain, was unable to walk, leg was stiff, was in bed for three days unable to get up and nerve sensation in leg was gone. The patient's medical history was not provided. Concomitant medications reported included valsartan, amlodipine, simvastatin, acetylsalicylic acid, potassium and gabapentin. On 29 Jan 2021, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch 031L20A) intramuscularly for prophylaxis of COVID-19 infection. On 30 Jan 2021, the patient complained of sharp electrical shocks in her knee. On 01 Feb 2021, her knee was swollen, warm to the touch and looked inflamed. She also reported what looked like an infection under her right thigh as the whole quad was reddened and inflamed. On 03 Feb 2021, the patient reported her lower leg looked purplish, did not have strength in her legs, felt weak, and her leg flopped to side of car as she reported losing muscle ability. On 04 Feb 2021, she experienced leg pain, was unable to walk, leg stiffness, was in bed for 3 days unable to get up and lost nerve sensation in her leg. Treatment for the event included unspecified therapy. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, right leg had been paralyzed, sharp electrical shocks in knee, right quad was reddened, right quad was inflamed, knee was swollen, knee was warm to touch, knee was inflamed, leg looked purplish, did not have strength in legs, felt weak, lost muscle ability of leg, leg pain, was unable to walk, leg was stiff, was in bed for three days unable to get up and nerve sensation in leg was gone, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported event, a causal relationship cannot be excluded. Arthralgia is consistent with the known safety profile of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,UNK,VALSARTAN; AMLODIPINE; SIMVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]; POTASSIUM; NEURONTIN,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Arthralgia', 'Arthritis', 'Asthenia', 'Bedridden', 'Erythema', 'Gait inability', 'Inflammation', 'Monoplegia', 'Muscular weakness', 'Musculoskeletal stiffness', 'Pain in extremity', 'Sensory loss']",1,MODERNA, 1050994,TX,67.0,F,"heart rate was low; pupils looked tiny; no color on face, pale; speech was completely slurred; afraid she was going to die; head and hands felt heavy; extremely tired, could barely lift a glass; Blood pressure went way up; felt groggy; back pain; back spasms alternating with throbbing in her back that was quite significant; A spontaneous report was received from a (Reporter like HCP or Consumer) concerning a � Years-old male/female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced back pain, back spasms alternating with throbbing in her back that was quite significant, pain was so horrific, blood pressure went way up, spasms continued, went into a deep sleep, felt groggy, feeling extremely tired, very motionless all night, thought she was in a coma, pupils looked tiny, no color on her face, was pale, so fatigued, could barely lift a glass, heart rate was low, never felt anything like that before, speech was completely slurred, truly afraid she was going to die, could barely move her hand from sofa, head felt really heavy,hands felt really heavy. The patient's medical history was not provided. No relevant concomitant medications were reported. On 10:12 am 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the left upper arm for prophylaxis for COVID-19 infection. On 6/Feb/2021, The patient experienced back pain, back spasms alternating with throbbing in her back that was quite significant. On 7/Feb/2021,The patient experienced, pain was so horrific, blood pressure went way up, spasms continued, went into a deep sleep, felt groggy, feeling extremely tired. On 8/Feb/2021,The patient experienced very motionless all night, thought she was in a coma, pupils looked tiny, no color on her face, was pale, so fatigued, could barely lift a glass, heart rate was low, never felt anything like that before, speech was completely slurred, truly afraid she was going to die, could barely move her hand from sofa, head felt really heavy,hands felt really heavy. Treated with Baclofen, IV with morphine, Tylenol, Motrin, back patch with lidocaine. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events were unknown.; Reporter's Comments: This case concerns a 67-year-old female who had a serious unexpected event of Heart rate decreased with NS unexpected blood pressure increased, pallor, miosis, dysarthria, back pain, muscle spasms, discomfort, somnolence, fear of death and NS expected fatigue. Event onset 1 day after first dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/06/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Hypertension (controlled hypertesnion),,,"['Back pain', 'Blood pressure increased', 'Discomfort', 'Dysarthria', 'Fatigue', 'Fear of death', 'Heart rate decreased', 'Miosis', 'Muscle spasms', 'Pallor', 'Somnolence']",1,MODERNA,OT 1050995,NE,,U,"Partially Frozen Vaccine Administered to 3 Patients; A spontaneous report was received from a HCP concerning three patients who received Moderna's COVID-19 vaccine (mRNA-1273) and 3 doses of vaccine were administered from a vial which was then observed to contain partially frozen vaccine. The patients' medical history was not provided. No relevant concomitant medications were reported. On unknown date, three patients received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On unknown date, 3 doses of vaccine were administered from a vial which was then observed to contain partially frozen vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were resolved.; Reporter's Comments: This report refers to a case of Out of Specification Product Use for mRNA-1273 (lot# not provided) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,['Out of specification product use'],1,MODERNA,OT 1050996,MI,,M,"Patients who is 17 years of age got Moderna Vaccine; A spontaneous report was received from a healthcare professional concerning a 17-year-old patient, of unknown gender, who was administered Moderna's COVID-19 vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of Covid-19 infection. It was reported that one of their patients who is 17 years of age, got Moderna Vaccine, and it was already reported to VAERS. No further information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not applicable. The event of ""Product administration to patient of inappropriate age"" (patient who is 17 years of age and got Moderna Vaccine), was considered resolved.; Reporter's Comments: This report refers to a case of ""Product administration to patient of inappropriate age"" of mRNA-1273, (lot # is unknown), with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1050997,AL,77.0,M,"seizure; hospital staff ""couldn't wake him up""; A spontaneous report was received from a consumer who was also a 77-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a seizure. He was hospitalized for one night and the staff had a difficult time waking him up. The patient's medical history included prostate cancer last year. Patient provided that he takes 8 or 10 different medications daily but did not list them out. No other medical history was shared and patient has no known drug or food allergies. On 30-Jan-2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 31-Jan-2021, the day after the mRNA-1273 vaccine was given, the patient had a seizure and was hospitalized for one night. He stated that the hospital staff had a hard time waking him up. He spent one night in the hospital and was released on 01-Feb-2021. It was not reported what caused the seizure and the patient was unsure if the hospital knew that he had the vaccination the day prior. He was discharged with Keppra. Consent to contact was given by the patient to contact him and the hospital. No further treatment information was not provided. Action taken with mRNA-1273 was not reported. The events, seizure and depressed consciousness level, were considered resolved on 01 Feb 2021.; Reporter's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/30/2021,01/31/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Prostate cancer (Patient reported only that he had prostate cancer last year.),,,"['Depressed level of consciousness', 'Seizure']",1,MODERNA,OT 1050998,MA,86.0,M,"He can barely see/he cannot see/his vision is getting worse and worse/visions problems; This is spontaneous report from a contactable consumer who reported for her father. An 86-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Jan2021 (at the age of 86-year-old) as a single dose for COVID-19 immunization. Medical history included two ongoing autoimmune diseases from unspecified dates and an ongoing pacemaker from an unspecified date. Concomitant medications included ongoing blood thinners from an unspecified date. The patient experienced he can barely see/he cannot see/his vision is getting worse and worse and vision problems, both on unspecified dates. The patient's child called and stated that ""my father is on blood thinner. He has two autoimmune diseases and has a pacemaker. He developed visons problems within a few days after receiving the first dose of Pfizer COVID-19. Now he cannot take care of his dog. He will not be able to take care of himself. His vision has gotten progressively worse, he can barely see. I spoke to the specialist and other doctors, but they have no information. He will be seeing the doctor in 2 weeks only. I reported the side effects online. It was hard to get medical help because not many people are informed about what might go on with the vaccine. To get him diagnosed has been difficult. They can't do an MRI on him because he has a pacemaker. He is also 2 weeks out to see a specialist. In the meantime, he cannot see. His vision is getting worse and worse. His next vaccine is coming up too."" The reporter had called and spoke with the director of immunization at the health department. She had also called and talked to VAERS as well. No one could point her to any help. The reporter believed this was probably related to the autoimmune diseases. The patient had no consultation not take the vaccine. The reporter had answered some information on the website while she had been waiting. The rest of the family also had autoimmune issues, and now they were all wondering if it was safe for them to take (the vaccine). The reporter wanted to know if we could provide any recommendations and if her father could get the second dose of the COVID-19 vaccine. The clinical outcome of the event was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,,,UNK,,Autoimmune disorder (Two autoimmune diseases); Pacemaker insertion (cardiac),,,,['Visual impairment'],1,PFIZER\BIONTECH, 1050999,,,M,"diverticulitis; This is a spontaneous report from a contactable nurse from a Pfizer-sponsored program. A 72-year-old male patient received the first dose on BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Jan2021 as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient developed diverticulitis and was on 2 antibiotics (not specified). It was reported that it was not a bad or severe bout. The clinical outcome of the event diverticulitis was unknown. No follow-up attempts are possible; information about lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,,,UNK,,,,,,['Diverticulitis'],1,PFIZER\BIONTECH, 1051000,MD,87.0,M,"fall; bruised rib; bruised hip; This is a spontaneous report from a contactable consumer (reporting for his father). An 87-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date: 30Apr2021), via an unspecified route of administration into the left arm on 12Jan2021 at a single dose for COVID-19 immunisation (COVID prevention). The patient's medical history included Alzheimer's disease and stroke. There were no concomitant medications. The reporter was calling regarding his father who was an 87-year-old combat veteran. The reporter stated that the patient received the first dose of the Pfizer COVID Vaccine on 12Jan2021. The patient was scheduled for his second dose on 02Feb2021, but they had to cancel that appointment because the patient was in the hospital from a fall he had on 29Jan2021 where he bruised his hip and bruised his rib. The patient was hospitalized from 30Jan2021 and was released from the hospital on 05Feb2021. The reporter stated that the clinic said they are not able to make any more appointments right now. The reporter was wondering if there were consequences of, or a danger in, getting the second dose outside of the recommended timeframe. The patient is now on a waiting list to get the second dose and he would like to know how far past the recommended 21 days can he go and still have the vaccine be effective. The patient received no other vaccines on the same day as the COVID vaccine. The patient has had an MRI before where it was indicated that there were some spots from a past stroke. The reporter stated that no paralysis has been identified. The outcome of the events was unknown.",Not Reported,,Not Reported,Yes,6.0,Not Reported,U,01/12/2021,01/29/2021,17.0,UNK,,,Medical History/Concurrent Conditions: Alzheimer's disease; Stroke,,,"['Chest injury', 'Contusion', 'Fall', 'Magnetic resonance imaging']",1,PFIZER\BIONTECH, 1051001,OH,81.0,F,"dementia is getting worse; headaches; This is a spontaneous report from a contactable consumer (patient's child). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 23Jan2021 (at the age of 81 years old) at a single dose for covid-19 immunization. Medical history included dialysis from 2015 and ongoing and ongoing dementia. The patient's concomitant medications were not reported. On unspecified date in Jan2021, the patient started getting headaches and that her dementia is getting worse. Therapeutic measures were taken as a result of headaches which included BC powder and acetaminophen (TYLENOL). Outcome of the events was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,01/01/2021,,UNK,,Dementia; Dialysis,,,,"['Dementia', 'Headache']",1,PFIZER\BIONTECH, 1051002,IL,86.0,M,"hard on hearing/lost his hearing; pain in his right ear; Chills; headache; Fever; Weakness; lacking appetite; This is a spontaneous report from a contactable consumer (patient's wife). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9810, expiration date was not reported) (at 86 years of age), via an unspecified route of administration in the left arm on 03Feb2021 15:00 at a single dose for COVID-19 immunization. Medical history included ongoing chronic lymphocytic leukaemia, ongoing blood pressure abnormal and ongoing thyroid disorder. Concomitant medication included hydrochlorothiazide which he was taking for years, ibrutinib which he was taking for 7 years, levothyroxine which he was taking for 10 years and losartan which he was taking for 8 years. The patient had no any other vaccine prior to covid vaccine. It was reported that the patient received the Pfizer covid vaccine on 03Feb2021. 24 hours later (04Feb2021), he experienced pain in the ears, headache, chills, and fever up to 101.5 for almost a week now, and currently is hard on hearing and had been feeling weak and lacking appetite. It was added that a week ago he received the first dose of the Pfizer COVID 19 vaccine on 03Feb2021 at 1500PM in the left arm. Within 24 hours the side effects started. He had a pain in his right ear and a headache. Since then he has gradually lost his hearing in that ear and they are following up with an ear nose and throat doctor. On 04Feb2021, he got a fever of 101.5, chills, weakness and no appetite. Since then in the evening he had been having kind of a fever of 100 to 100.5 and she has treated with TYLENOL. The fever comes and goes. In the morning he was normal. Adds his appetite was better but he still has to force himself to eat. She queried if should the patient get the second dose of the vaccine. Patient is scheduled to receive the second dose on 04Mar2021. The patient did not visit the ER. The patient underwent lab tests and procedures which included body temperature: up to 101.5, fever of 100 to 100.5, and 101.5 on 04Feb2021. The outcome of the event loss of hearing, fever, weakness, and pain in his right ear was not recovered; headache and chills are recovered on 05Feb2021; while recovering for lacking appetite. The loss of hearing was reported as worsened. Therapeutic measures were taken as a result of fever (pyrexia).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,PVT,HYDROCHLOROTHIAZIDE; IBRUTINIB; LEVOTHYROXINE; LOSARTAN,Blood pressure abnormal; Chronic lymphocytic leukaemia; Thyroid disorder,,,,"['Asthenia', 'Body temperature', 'Chills', 'Deafness', 'Decreased appetite', 'Ear pain', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH, 1051003,UT,71.0,F,"Bell's Palsy; This is a spontaneous report from a contactable consumer, reporting for herself. A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration at the left arm on 27Jan2021 15:15 at a single dose for COVID-19 immunization. Vaccination was done in a Public Health Department. Medical history included hypertension (HTN), gastrooesophageal reflux disease (GERD), total hysterectomy and osteoarthritis, all from an unknown date and unknown if ongoing. The patient was not pregnant. There were no known drug allergies. Concomitant medication included celecoxib (CELEBREX), omeprazole magnesium (PRILOSEC), estradiol (ESTRACE), metoprolol succinate (TOPROL XL) and ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION). It was reported that the patient experienced right sided neck pain which began a couple of days after vaccination on 06Feb2021 07:00. On 05Feb2021, her right eye was twitchy. On 06Feb2021, the right side of her face felt swollen. It felt like when you go to the dentist and get numbed. She tried drinking a liquid and it ran out of the right side of her mouth. She went to urgent care and they sent her to the emergency department. She had a CAT-scan, MRI and blood work done which all came back normal. Her right eye was not closing all of the way and they diagnosed her with Bell's Palsy on 07Feb2021. She was prescribed a course of prednisone and Valtrex. She has continued to have right-sided facial paralysis and her right eye will not close. She had had severe pain in her right eye and had to tape it shut to sleep and often during the day because it dries out. She was using Systaine eye drops every couple of hours and an eye gel at night. She was concerned about getting the second dose because she does not want this to get worse. There were no other vaccines in four weeks. There was no COVID prior to vaccination and was not COVID tested post vaccination. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/05/2021,9.0,PUB,CELEBREX; PRILOSEC [OMEPRAZOLE MAGNESIUM]; ESTRACE; TOPROL XL; PRESERVISION,,Medical History/Concurrent Conditions: GERD; Hypertension; Osteoarthritis; Total hysterectomy,,,"['Blood test', 'Computerised tomogram', 'Facial paralysis', 'Magnetic resonance imaging']",1,PFIZER\BIONTECH, 1051004,,50.0,F,blood clot; This is a spontaneous report from a contactable consumer. A 6-decade-old female patient (in her 50's) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as vaccine. Medical history and concomitant medications were not reported. It was noted that one of the reporter's co-worker developed a blood clot after receiving the first dose of the Pfizer vaccine on an unspecified date. Any information or data on someone developing blood clots? The outcome of the event was unknown. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Thrombosis'],1,PFIZER\BIONTECH, 1051005,,,M,"Thyroid cancer; paraganglioma; headache; constant fatigue; nausea; pump in blood pressure/hypertension; 3-day pain in the chest, his pain in the chest turned out to be an LBBB or left bundle branch block; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received first single dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 27Jan2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After receiving the first dose (onset date: 2021), he experienced AEs like constant fatigue, nausea, pump in blood pressure/ jumping blood pressure, and 3-day pain in the chest. He had a cardiogram and his pain in the chest turned out to be an LBBB or left bundle branch block. On an unspecified date, the patient had been diagnosed with thyroid cancer and was now with remission; paraganglioma, hypertension, 0left bundle branch block, and headache. The pain in the chest subsided after 3 days but nausea, headache and fatigue were still being experienced a few days after. He said that he has read that most of the side effects of the vaccine manifests on the second dose. Because he had bad AEs with the first dose, he was seeking the company for recommendations for having the second dose of the vaccine. The outcome of fatigue, nausea and headache was not recovered while unknown for the other events. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,,,UNK,,,,,,"['Bundle branch block left', 'Echocardiogram', 'Fatigue', 'Headache', 'Hypertension', 'Nausea', 'Paraganglion neoplasm', 'Thyroid cancer']",1,PFIZER\BIONTECH, 1051006,NE,70.0,F,"nauseous; severe stomach cramps; shortness of breath; chest tightness; diaphoretic; chilled; cold to the touch, ashen; cold to the touch, ashen; patient was treated as if a heart attack; This is a spontaneous report from a contactable healthcare professional (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 29Jan2021 15:30 at a single dose for Covid-19 immunization. Medical history included high BP, and cholesterol. Patient had no known allergies. Concomitant medications included amlodipine and simvastatin. The patient experienced nauseous, severe stomach cramps, shortness of breath, chest tightness, diaphoretic, chilled, cold to the touch, ashen on 01Feb2021 at 15:30. Ambulance was called, patient was brought to the ER and was hospitalized on an unknown date for 2 days. Treatment of events: patient was treated as if a heart attack, nitro, baby aspirin. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not tested positive for Covid-19 after vaccination. Outcome of the events was recovered. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on a compatible temporal relation. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/29/2021,02/01/2021,3.0,UNK,AMLODIPINE; SIMVASTATIN,,Medical History/Concurrent Conditions: Blood pressure high; Cholesterol,,,"['Abdominal pain upper', 'Chest discomfort', 'Chills', 'Dyspnoea', 'Feeling cold', 'Hyperhidrosis', 'Myocardial infarction', 'Nausea', 'Pallor']",1,PFIZER\BIONTECH, 1051007,,79.0,F,"sinus infection; cannot see out of her right eye; sick; terrible terrible splitting headache on her right temple; can't sleep; pressure behind her right eye; head is all fuzzy; mind isn't good; throat hurts; jaw hurts; little off balance; she walks she falls into things; she walks she falls into things; can't see things hardly in her right eye; pain; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiration date were not reported), via an unspecified route of administration on 04Feb2021 at single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medication included atenolol for blood thinner. The patient previously took first dose of bnt162b2 for Covid-19 immunization and experienced no adverse event. The patient stated that she received the second dose of the vaccine on 04Feb2021 and has been sick ever since. She has a terrible terrible splitting headache on her right temple and can't sleep and was having so much pressure behind her right eye. She stated she can't even lay her head on a pillow. She stated she had no reaction to the first shot but this time her head is all fuzzy, her mind wasn't good and when she sets things down she can't remember where they are. The second shot was really giving her a fit. Her throat hurts, jaw hurts, head hurts, and feels like she is running a temperature. She is a little off balance, when she walks she falls into things because she can't see things hardly in her right eye. She stated she can't put up with the pain any longer, it is terrible behind her temple and eye. She thought it was a sinus infection but now she thinks it was from the shot. She stated she almost had a wreck today because she cannot see out of her right eye because of the shot. She hit a telephone thing and almost wrecked 3 or 4 times. She tried to get tested for Covid but she didn't have an appointment and she cannot go to work until she finds out about the virus. She was going to get tested tomorrow but was going to have to call the rescue squad because she can't drive and she was not putting her son through this if she has the virus. The patient asked if she was allergic to the second shot or if these were normal symptoms. She asked what she should do. She stated she takes Atenolol, a blood thinner, and thyroid medicine. She stated she was taking Tylenol but it doesn't help any and nothing seems to help. All the events occurred on Feb2021. Outcome of all the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/01/2021,,UNK,ATENOLOL,,,,,"['Balance disorder', 'Blindness', 'Fall', 'Feeling abnormal', 'Gait disturbance', 'Headache', 'Insomnia', 'Malaise', 'Memory impairment', 'Ocular discomfort', 'Oropharyngeal pain', 'Pain', 'Pain in jaw', 'Sinusitis', 'Visual impairment']",2,PFIZER\BIONTECH, 1051008,,,M,"Can not think or talk normal; Can not think or talk normal; Rash from his feet to his neck; Dizziness; Weakness; Loss of appetite; Heart pounds; Flu; Described the rash like hives; This is a spontaneous report from a contactable consumer. A male patient (Age: 78; Unit: Unknown) of an unspecified received his first dose of bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated that he can not think or talk normal, had rash from his feet to his neck, dizziness, weakness, loss of appetite, heart pounds at night, feels like he has the flu, described the rash like hives. Outcome of the events was unknown. Information on lot and batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Asthenia', 'Decreased appetite', 'Dizziness', 'Influenza', 'Mental impairment', 'Palpitations', 'Rash', 'Speech disorder', 'Urticaria']",1,PFIZER\BIONTECH, 1051009,NJ,83.0,F,"elevated blood pressure; had trouble breathing; Pneumonia; didn't feel well; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 04Feb2021 10:30 at single dose for COVID-19 immunization. Medical history included diabetes, chronic obstructive pulmonary disease (COPD), high blood pressure, high cholesterol, and prior lung cancer. The patient was not pregnant. The patient had no known allergies. Concomitant medications included insulin detemir (LEVEMIR), metoprolol, umeclidinium bromide, vilanterol trifenatate (ANORO ELLIPTA), metformin, levothyroxine, saxagliptin hydrochloride (ONGLYZA), and atorvastatin. The patient received first dose of bnt162b2 on 14Jan2021, 10:30 for COVID-19 immunization. It was reported that 2 nights following vaccine, patient had trouble breathing and didn't feel well on 07Feb2021, 12:30. Patient started to feel better but again two days later, she had trouble breathing and elevated blood pressure on 09Feb2021. Patient was admitted to the hospital for 2 days due to the events on an unspecified date and was diagnosed with pneumonia. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. There was unspecified treatment for the events. It was reported that patient was currently hospitalized. The patient did not have other vaccine in four weeks, no covid prior vaccination and was not covid tested post vaccination. Outcome of events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/04/2021,02/07/2021,3.0,SEN,LEVEMIR; METOPROLOL; ANORO ELLIPTA; METFORMIN; LEVOTHYROXINE; ONGLYZA; ATORVASTATIN,,Medical History/Concurrent Conditions: Blood pressure high; COPD; Diabetes; High cholesterol; Lung cancer,,,"['Blood pressure increased', 'Blood pressure measurement', 'Dyspnoea', 'Malaise', 'Pneumonia']",2,PFIZER\BIONTECH, 1051010,MN,84.0,F,"blindness in one eye; delirium; Weakness; This is a spontaneous report from a contactable consumer. An 84-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left arm on 03Feb2021 11:15 at a single dose for covid-19 immunization. Medical history included congestive heart failure, diabetes, glaucoma, breast cancer survivor, high blood pressure and allergies. The patient has unspecified concomitant medications. On 03Feb2021 21:30, the patient experienced blindness in one eye, weakness and delirium. The patient did not receive treatment for the events. The events were assessed serious, disability. The patient has not tested positive to covid prior vaccination. The outcome of the events was not recovered. Information on Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/03/2021,02/03/2021,0.0,OTH,,,Medical History/Concurrent Conditions: Allergy; Blood pressure high; Breast cancer; Congestive heart failure; Diabetes; Glaucoma,,,"['Asthenia', 'Blindness', 'Delirium']",UNK,PFIZER\BIONTECH, 1051011,OH,83.0,M,"Urinary tract infection; high blood pressure; Fall; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer sponsored program. An 83-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiration date: 31Mau2021), via an unspecified route of administration on 02Feb2021 13:12 at SINGLE DOSE for Covid-19 immunisation. Medical history included heart surgery (Between 6-9 years before), Congestive heart failure, blood pressure (problems with blood pressure) and fall (history of falls). Concomitant medication included ongoing carvedilol for Congestive heart failure. The reporter stated that her husband has high blood pressure (occurred on an unspecified date) and was having problems falling. He fell the night of 03Feb2021. She called the paramedics to come help get him up. He was taken to the emergency room on the morning of 04Feb2021. He was found to have a urinary tract infection (on 04Feb2021) and was admitted. The patient was hospitalized for the event urinary tract infection on an unspecified date for 2 days. He is now in rehab and will have to learn to walk again. She is calling to ask what needs to be done about her husband getting the second dose. The patient underwent lab tests and procedures which included blood pressure: 150/90, CT scan, labs, urine test and X-rays: unknown, weight: 175-180 lbs on an unspecified date. Outcome of the event urinary tract infection was recovered with sequelae on 06Feb2021. Outcome of the event fall was recovered with sequelae on 03Feb2021 while outcome of the event blood pressure increased was recovering.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/02/2021,02/03/2021,1.0,UNK,CARVEDILOL,,Medical History/Concurrent Conditions: Blood pressure (problems with blood pressure); Congestive heart failure; Fall (history of falls); Surgery (Between 6-9 years ago),,,"['Blood pressure increased', 'Blood pressure measurement', 'Computerised tomogram', 'Fall', 'Investigation', 'Urinary tract infection', 'Weight', 'X-ray']",1,PFIZER\BIONTECH, 1051012,FL,74.0,F,"Kidney infection; Wheezing in chest; her blood pressure is so low right now they can't even transfer her to the hospital that can actually perform the surgery she needs; became very weak and didn't tell anyone/too weak to get up; mother was swollen from head to toe with edema; mother was swollen from head to toe with edema; fell using her walker on Wednesday/fell again; Laceration of face; having issues with her kidneys and has progressively declined since; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history using her walker. Concomitant medications were not reported. The consumer reported that her mother had the COVID-19 Vaccine on 21Jan2021. She was now hospitalized and was due to have the second vaccine on 11Feb2021 and stated that her mother was completely unstable for the second vaccine. After receiving the COVID-19 vaccine, medically, she seemed fine. Then, she progressively has gotten worse. First EMS was called. This was about less than a week later after receiving the vaccine. Then, she was admitted into the hospital with a kidney infection and she has progressively declined. She has no idea if it was related to the COVID-19 vaccine or not. She initially called regarding the second COVID-19 vaccine. She didn't know what would happen if her mother didn't show up for her second vaccine. She didn't know if she would get on the ""never going to get the vaccine"" list or what as her mother was just so unstable. On an unspecified date, her blood pressure was so low right now they can't even transfer her to the hospital that can perform the surgery she needs. The reporter stated that she has no idea if this was COVID related or what. She began having problems less than a week later after receiving the COVID-19 vaccine, she mentioned Wednesday. On 27Jan2021, her mother began having issues with her kidneys and has progressively declined since. Consumer stated her mother was swollen from head to toe with edema on an unspecified date and that was how this all kind of started. Her mother became very weak and didn't tell anyone. She fell using her walker on Wednesday and the EMS was called. Her mother told the EMS she wasn't hurt but was just too weak to get up and EMS got her up. Her primary care doctor sent her for an x-ray, and she had some wheezing in her chest. She was given an antibiotic for that. The patient fell again, and the EMS was called and had some face lacerations and stuff, so she was taken to the hospital. Consumer confirmed her mother was admitted into the hospital and was first diagnosed with a kidney infection and it has progressively gotten worse. Outcome of event kidney infection was not recovered; and outcome of the rest of events was unknown. Information on lot/Batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/21/2021,01/27/2021,6.0,UNK,,,Medical History/Concurrent Conditions: Walker user,,,"['Asthenia', 'Fall', 'Hypotension', 'Kidney infection', 'Oedema', 'Renal disorder', 'Skin laceration', 'Swelling', 'Wheezing', 'X-ray']",1,PFIZER\BIONTECH, 1051013,NY,36.0,F,"Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as if I was going to pass out. I had muscle weakness in my arms and legs. I managed to pull over safely; Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as if I was going to pass out. I had muscle weakness in my arms and legs. I managed to pull over safely; Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as if I was going to pass out. I had muscle weakness in my arms and legs. I managed to pull over safely; Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as if I was going to pass out. I had muscle weakness in my arms and legs. I managed to pull over safely; I was nauseous and couldn't walk; I was nauseous and couldn't walk; Felt like immediate drop in blood pressure; This is a spontaneous report from a contactable consumer. A 36-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN5318, via an unspecified route of administration at left arm on 09Feb2021 10:00 at a single dose for COVID-19 immunisation. The patient had no medical history. The patient is not pregnant. There were no concomitant medications. On 09Feb2021, exactly two hours after injection, the patient felt lightheaded and dizzy while driving, then tunnel vision as if she was going to pass out. The had muscle weakness in my arms and legs. The patient managed to pull over safely. She was nauseous and couldn't walk. This lasted about 15 minutes and then she was better. The patient felt like immediate drop in blood pressure. No treatment was received. The outcome of the events was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,SCH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Blood pressure decreased', 'Blood pressure measurement', 'Dizziness', 'Gait disturbance', 'Muscular weakness', 'Nausea', 'Tunnel vision']",1,PFIZER\BIONTECH, 1051014,OR,45.0,F,"Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated blood pressure; heavy burning sensation in my chest; extreme body aches; so dizzy I can barely stand; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 01Feb2021 15:00 at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included Migraine, anxiety. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), thyroid, naltrexone hydrochloride (NALTREXON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Allergies to Erythromycin, morphine. The patient received the first dose of BNT162B2 via an unspecified route of administration at right arm on 08Jan2021 02:30 PM for COVID-19 immunization. The patient experienced Waves of extreme nausea, chills and dizziness, Shakiness, Vomiting and elevated temperature. Elevated blood pressure on 02Feb2021 15:15, After a week and a half in Feb2021, the patient had heavy burning sensation in her chest, extreme body aches, so dizzy she can barely stand. Events were assessed as serious with seriousness criteria-Disabling/Incapacitating. Adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Blood tests, electrocardiogram (EKG), chest X-ray on an unknown date in Feb2021 with unknown results, Nasal Swab Covid test on 02Nov2020: Negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/01/2021,02/01/2021,0.0,WRK,ZOLOFT; THYROID; NALTREXON,,Medical History/Concurrent Conditions: Anxiety; Migraine,,,"['Blood pressure increased', 'Blood pressure measurement', 'Blood test', 'Body temperature', 'Body temperature increased', 'Chest X-ray', 'Chest pain', 'Chills', 'Dizziness', 'Dysstasia', 'Electrocardiogram', 'Nausea', 'Pain', 'SARS-CoV-2 test', 'Tremor', 'Vomiting']",2,PFIZER\BIONTECH, 1051015,,,F,"a heart attack; I had a blood clot in my lung; stabbing pain in chest; This is a spontaneous report from a contactable consumer. A 76 years old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. About 30 hours after 1st dose of vaccine the patient experienced stabbing pain in chest wall, quite persistent. At first she thought was having an heart attack. Hurt too much to move. Had to lay down. Thought she had a blood clot in her lung severe for 2 days, moderate for 2 day. It was dissipated after 6 days. The patient was scheduled for second dose on 20Feb2021. The patient recovered from the events on an unspecified date. Information about Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Chest pain', 'Myocardial infarction', 'Pulmonary thrombosis']",1,PFIZER\BIONTECH, 1051016,,75.0,M,"congestive heart; renal failure; very weak; This is a spontaneous report from a non-contactable consumer. A 75-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Feb2021 at single dose for COVID-19 immunisation at the age of 75-year-old. Medical history and concomitant medications were unknown. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jan2021 at single dose for COVID-19 immunisation at the age of 75-year-old. On 07Feb2021, patient became very weak; the patient was hospitalized with renal failure and congestive heart. It was unknown if any treatment was administered due to the events. The patient did not recover from the events. The patient did not have Covid-19 before vaccination; it was unknown if Covid was tested post vaccination. No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/06/2021,02/07/2021,1.0,PUB,,,,,,"['Asthenia', 'Cardiac failure congestive', 'Renal failure']",2,PFIZER\BIONTECH, 1051017,NY,,M,"Anemia; This is a spontaneous report from a contactable Other-HCP. This 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, in Jan2021 at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included ongoing chronic obstructive pulmonary disease (COPD), ongoing diabetes, ongoing high blood pressure and ongoing high cholesterol. The patient received a lot of concomitant medications (no additional details were provided). On 26Jan2021, the patient developed anemia for which he was admitted to the hospital on the same day. The patient was recovering from the event. Information on Batch/Lot number has been requested.; Sender's Comments: Based on the limited information provided and temporal association, a causal association between the reported event and the BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/01/2021,01/26/2021,25.0,UNK,,Blood pressure high; COPD; Diabetes; High cholesterol,,,,['Anaemia'],1,PFIZER\BIONTECH, 1051018,TN,29.0,F,"After the vaccine the patient miscarried the baby; This is a spontaneous report from Pfizer-sponsored program via a contactable pharmacist. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), 0.3 ml via an unspecified route of administration on 15Jan2021 at 10:00-11:30am as a single dose for COVID-19 immunization, administered in the right arm. Patient has no past medical history. Concomitant medication includes One-a-day vitamin, Ongoing. No prior Vaccinations within 4 weeks prior. First Day of Last menstrual period: 6-13 Dec2020. Patient reports one previous pregnancy: full term live birth via vaginal birth with epidural at 40 weeks and 1 day. The father used marijuana, at an unspecified frequency. Patient was unaware that she was pregnant, guesses she was about 3 weeks when she got the first shot of the vaccine. Ten days after the vaccine, the patient miscarried the baby. The clinical outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Miscarriage of pregnancy cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Pregnancy (full term live birth via vaginal birth with epidural at 40 weeks and 1 day),,,['Abortion spontaneous'],1,PFIZER\BIONTECH, 1051019,OH,75.0,F,"Hives; Itching; She had cracking creases with serous fluid coming out of both hands; She was covered big blisters; blotches; Her hands were so swollen after getting the dose of the vaccine that she couldn't get them closed; This is a spontaneous report from a contactable nurse, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in the left arm on 05Feb2021 at 12:20 (at the age of 75-year-old) as a single dose for COVID-19 vaccination. Medical history included reverse total shoulder replacement on 26Jan2021, cardiomyopathy from an unknown date, and type 2 diabetes mellitus from an unknown date. There were no concomitant medications. The patient previously received her shingles shot (MANUFACTURER UNKNOWN) and flu shot (MANUFACTURER UNKNOWN); both in Oct2020 for immunization and had no reactions. On 05Feb2021 at 16:00, the patient experienced hives and itching. On 05Feb2020, the patient had blotches, blistering, swollen hands, and cracked creases with serous fluid coming out of the hands. The clinical course was as follows: She had absolutely no problem at the time of the injection, no soreness with it she was fine and then she had welts starting with 2-3 then all over her body, that were itching terribly. They stared on the left wrist, both hands. The patient took diphenhydramine hydrochloride (BENADRYL); but it did not help. The patient then went to the emergency room (ER). By the time she got to the ER, the hives moved up to her abdomen and she was covered in big blistery looking raisings and few small raises on her trunk and arms. The hives were concentrated from her fingers to her elbow, and then there were other blotches on her elbows to her fingers that were real concentrated. She stayed at the hospital for 3 hours, but she was not admitted. At the ER, she received pantoprazole (PROTONIX), diphenhydramine hydrochloride, hydroxyzine (ATARAX) and prednisone (MANUFACTURER UNKNOWN). The patient also stated that her hands were so swollen after getting the dose of the vaccine that she couldn't get them closed and she had cracking creases with serous fluid coming out of both hands. The swelling went down a little bit the next day; but she still had the blotches. She said the itch was tolerated. However, the blistering started again. Her doctor put her on a sliding scale of prednisone and diphenhydramine at 25 mg every 6 hours. The clinical outcome of the swelling hands was recovering; while that of the blotches and blisters were not recovered. The clinical outcomes of the hives, itching, and cracked creases with serous fluid coming out of the hands were unknown. The patient assessed the events to be medically significant as she had never experienced anything like this.; Sender's Comments: Considering the temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of the reported events cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Cardiomyopathy (Verbatim: Cardiomyopathy); Reverse shoulder replacement (Verbatim: reverse total shoulder replacement); Type 2 diabetes mellitus (Verbatim: Type 2 diabetes mellitus),,,"['Blister', 'Peripheral swelling', 'Pruritus', 'Rash macular', 'Skin fissures', 'Urticaria']",1,PFIZER\BIONTECH, 1051020,FL,,M,"He started not feeling too well; coughing like slimy kind of cough; Like congestion; he started to have some chills; Pain in arm; He got sick so bad; I think last year respiratory infection like his chest; He was hot; he had about 100.4; Diarrhea; He got sick so bad; I think last year respiratory infection like his chest; head seems to be very stuff; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 at SINGLE DOSE for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient took the first shot on 20Jan2021. The first day he felt okay he didn't feel like they gave him the shot as it went well. Then he has some arm pain (pain in arm) at night on 20Jan2021 about strictly went away. He took it on 20Jan2021 about 12'oclock in the afternoon. On Friday on 22Jan2021 and Saturday he started not feeling too well. He started coughing like slimy kind of cough on 22Jan2021. He was like congestion and then he started to have some chills and stuff like that on 22Jan2021. So that was almost three weeks ago. Like Saturday so this past Saturday was two weeks so today it was Tuesday so almost two and half weeks he hasn't gone out of the house. It was unknow if he was fine before he went took the shot. He got sick so bad 3 or 4 days later and he hasn't really feel well since then. Like before he took the shot but then also don't know if he has something different. He didn't go to get tested for Covid. He hasn't lost taste or smell. He seems like continuing he has like last year this time when we were in different part. He seems like he had last year respiratory infection like his chest but then he got better. He is easy to get all sick. He had fever he had like every time his temperature was always but he had about 100.4 in Jan2021. One at night he got chills and he was hot. He two Tylenol, he took lot of Tylenol in last two weeks. He felt like after he took the Tylenol he felt like it would take his temperature he took Tylenol right away and the fever went down. He hasn't had any fever it is been like 97 for 4-5 days. He has he feels like he had congestion but unknow if he picked up for cold or congestion just and right now try to see if he takes the shot tomorrow and he had just weird diarrhea. He still have his nose and his head seems to be very stuff. The wife did not know if he got sick from the shot or not. The outcome was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/01/2021,,UNK,,,,,,"['Body temperature', 'Chills', 'Cough', 'Diarrhoea', 'Illness', 'Malaise', 'Nasal congestion', 'Pain in extremity', 'Pyrexia', 'Respiratory tract infection', 'Sensory disturbance']",1,PFIZER\BIONTECH, 1051021,CA,75.0,F,"Bell's palsy; blood pressure increased; chest pain; breathing difficulty; weakness; tired; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (lot number: EL9262), via an unspecified route of administration, at arm left, on Jan2021 at single dose for COVID-19 immunisation. Medical history included Prediabetes from 2019 (reported as diagnosed two years ago), overweight from an unknown date, ongoing arthritis from 2017 (reported as about 4 years ago), gets worse now. There were no concomitant medications. Caller states she just has a question, states she took the test about 2 weeks ago, clarifies the Pfizer vaccine and due for next one on Sunday, caller wanted to find out if what she experienced could be due to the vaccine, states she had a reaction for almost two weeks (also reported that all the events started on 05Feb2021, pending clarification), states her blood pressure went up, she had chest pain in her chest, weakness, loss of appetite, states it lasted about 24 hours, no exact dates provided. Also experienced Bell's Palsy states it comes and goes, that when she talks the saliva comes down the side of her mouth. States her Blood pressure went really high, 145/90 or so, lasted about 24 hours. Did not know if she was having a heart attack. Does see a cardiologist because of a family history of cardiac issues. The outcome of the event Bell's Palsy was not recovered, of the other events was recovered on Jan2021 (reported as lasted for 24 hours).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,UNK,,"Arthritis (about 4 years ago, gets worse now.)",Medical History/Concurrent Conditions: Overweight; Prediabetes (diagnosed two years ago),,,"['Asthenia', 'Blood pressure increased', 'Blood pressure measurement', 'Chest pain', 'Decreased appetite', 'Dyspnoea', 'Facial paralysis', 'Fatigue']",1,PFIZER\BIONTECH, 1051022,CA,48.0,F,"Drug Ineffective; felt like she had Covid plus the flu; very congested chest; Flu like symptoms; Chest pain; Cough; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose (Lot # EL1283) intramuscular at single dose in the right arm on 15Jan2021 and the second dose at single dose in the left arm on 03Feb2021 11:30, for covid-19 immunisation. Medical history included exposure to sars-cov-2 in Dec2020 (Her mother ended up positive for Covid and she was exposed to her and showed symptoms). There were no concomitant medications. On 03Feb2021, the patient experienced felt like she had Covid plus the flu with outcome of recovered on 05Feb2021, very congested chest with outcome of recovered on 06Feb2021, flu like symptoms with outcome of recovered on 05Feb2021, chest pain with outcome of recovered on 05Feb2021, cough with outcome of recovered on 06Feb2021, shortness of breath with outcome of recovered on 06Feb2021. The patient underwent lab tests and procedures which included oxygen saturation: normal on an unspecified date, sars-cov-2 antibody test: positive on an unspecified date. Therapeutic measures were taken as a result of felt like she had covid plus the flu, flu like symptoms. The events were described as follows: Patient said that she had some weird side effects from the 2nd vaccine, but not the first dose and believes that she had Covid in Dec2020. Patient said that she had flu like symptoms, she said it felt like she had Covid plus the flu. She said that she also had chest pain, a very congested chest, a cough, and shortness of breath. She did not have that with Covid. She said that her symptoms came on about 10 hours after the vaccination and were gone within 48 hours. Patient said that she does not know if having Covid so recently plays into it at all. Patient said that she received the last dose on 03Feb2021 at 1130. Patient said that the phlegm started in her throat and she had the chills. She woke up with the whole shebang. She stated that it got worse by the next day. She said that she did not feel a thing from the first injection and had no side effects. She never tested positive for Covid in Dec2020. Her mother ended up positive for Covid and she was exposed to her and showed symptoms. She had exhaustion vertigo, and general feeling of being unwell with Covid. She had all of that again, but she was told not to expect anything respiratory. She got concerned with the chest pain, cough, phlegm, and shortness of breath. She saw the doctor on 05Feb2021 and she was instructed not to take anything because it could affect the vaccine, but her symptoms went away within 48 hours. She said that she felt like the congestion felt like a allergic reaction for her, said that it was hard to swallow, and had a lot of phlegm in her throat. She said that it is not inherently different if you were allergic to flowers. Chest pain she described like you are full of phlegm and like there is inflammation. Shortness of breath: Feel panicky when you try to breath and you feel the phlegm. Patient said that when she gets sick she does have a tendency to get upper respiratory infections. Like with a cold that she would end up with a cough that would linger a little bit. She still thinks getting the vaccine was worth it. She just wished that it would have been a listed side effect, because when it is not, you panic. Most people are worried about the shortness of breath. She reported that her O2 levels were ok when she checked. Doctor gave her a vitamin IV to make her feel better. Told her that her lungs were clear and it was all upper respiratory.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,02/03/2021,19.0,PVT,,,Medical History/Concurrent Conditions: Exposure to COVID-19 (Her mother ended up positive for Covid and she was exposed to her and showed symptoms),,,"['COVID-19', 'Chest pain', 'Cough', 'Drug ineffective', 'Dyspnoea', 'Influenza like illness', 'Oxygen saturation', 'Pulmonary congestion', 'SARS-CoV-2 antibody test']",1,PFIZER\BIONTECH,OT 1051023,AK,33.0,F,"Clinical depression (exhaustion, lack of ability to find pleasure or joy in anything, lack of interest in typical daily things, thoughts of suicide), fatigue, lack of focus, extreme emotional distress; Clinical depression (exhaustion, lack of ability to find pleasure or joy in anything, lack of interest in typical daily things, thoughts of suicide), fatigue, lack of focus, extreme emotional distress; Clinical depression (exhaustion, lack of ability to find pleasure or joy in anything, lack of interest in typical daily things, thoughts of suicide), fatigue, lack of focus, extreme emotional distress; emotional distress to include involuntary tears that would not stop; Clinical depression (exhaustion, lack of ability to find pleasure or joy in anything, lack of interest in typical daily things, thoughts of suicide), fatigue, lack of focus, extreme emotional distress; This is a spontaneous report from a non-contactable consumer (the patient). A non pregnant 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 27Jan2021 at 17:45 PM, (at the age of 33-year-old) as a single dose for COVID-19 immunization. Medical history included anxiety and depression (well under control at time of vaccination), COVID-19. The patient had known allergies to soy, almonds, green beans, peas, celery, cherries, strawberries, and eggs. Concomitant medication taken within two weeks of vaccination included cetirizine hydrochloride (ZYRTEC), diphenhydramine hydrochloride (BENADRYL), fluticasone propionate (FLONASE), and unspecified birth control. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin and cefdinir and experienced drug hypersensitivity. On 01Feb2021, the patient experienced clinical depression (described as exhaustion, lack of ability to find pleasure or joy in anything, lack of interest in typical daily things, thoughts of suicide). She also experienced fatigue, lack of focus, extreme emotional distress, to include involuntary tears that would not stop. The patient did not receive treatment for the events. The clinical outcome of the events clinical depression (described as exhaustion, lack of ability to find pleasure or joy in anything, lack of interest in typical daily things, thoughts of suicide), fatigue, lack of focus, extreme emotional distress to include involuntary tears that would not stop, was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. Information about lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/01/2021,5.0,UNK,ZYRTEC [CETIRIZINE HYDROCHLORIDE]; BENADRYL; FLONASE [FLUTICASONE PROPIONATE],,"Medical History/Concurrent Conditions: Anxiety (History of anxiety & depression - well under control at time of vaccination.); COVID-19 (if covid prior vaccination Yes); Depression (History of anxiety & depression - well under control at time of vaccination.); Egg allergy; Food allergy (soy, almonds, green beans, peas, celery, cherries,strawberries)",,,"['Crying', 'Emotional distress', 'Fatigue', 'Major depression', 'Suicidal ideation']",1,PFIZER\BIONTECH, 1051024,CA,,F,"Bloody diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose arm left on 30Jan2021 15:00 for covid-19 immunisation. Medical history included diabetes mellitus. Concomitant medication included sitagliptin (JANUVIA). The patient experienced bloody diarrhea on 06Feb2021. No treatment received. The outcome was recovered. Information on the lot/batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,02/06/2021,7.0,PUB,JANUVIA [SITAGLIPTIN],,Medical History/Concurrent Conditions: Diabetes,,,['Diarrhoea haemorrhagic'],1,PFIZER\BIONTECH, 1051262,CA,,F,"esophagus and trachea closed; experienced some heavy breathing; some pins and needles sensation around her outer thigh, hip bone, liver, and abdomen; arm felt like someone took a brick and kept pounding it; arm had hardness; the area was hot, hard, and heated; couldn't swallow saliva; Couldn't raise arm over shoulder; tongue felt like it was numb; Couldn't walk or stand up straight; A spontaneous report was received from a healthcare professional (HCP) concerning a 65-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced esophagus and trachea closing/tracheal inflammation, heavy breathing/dyspnea, pins and needle sensation around her outer thigh, hip bone, liver and abdomen/paraesthesia, arm felt like someone took a brick and kept pounding it/limb discomfort, arm had hardness/injection site induration, area was hot and heated/injection site warmth, couldn't swallow saliva/dysphagia, couldn't raise arm over shoulder/injection site movement impairment, tongue felt like it was numb/hypoaesthesia oral, and couldn't walk or stand up straight/gait inability. The patient's medical history was not provided. Concomitant medication history was not provided. On 03 FEB 2021, one day prior to the onset of the events, the patient received their first of two doses of mRNA-1273 (lot number: 043L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 04 FEB 2021, the patient experienced her esophagus and trachea closing. She had some heavy breathing along with pins and needle sensation around her outer thigh, hip bone, liver and abdomen. She stated that her arm felt like someone took a brick and kept pounding it. Her arm had hardness and she couldn't raise it over her shoulder. The area of her arm was hot, hard and heated. The patient couldn't swallow her saliva, couldn't walk or stand up straight and her tongue felt like it was numb and stretched out. An ambulance was called, and she was taken to the hospital. She stated that she had never had such a reaction to a vaccine before. She stated that since the event, her memory has been affected. Treatments of these events included saline solution, a medication for relaxing and pain, and oxygen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, esophagus and trachea closing/tracheal inflammation, heavy breathing/dyspnea, pins and needles sensation around her outer thigh, hip bone, liver and abdomen/paraesthesia, arm felt like someone took a brick and kept pounding it/limb discomfort, arm had hardness/injection site induration, area was hot, and heated/injection site warmth, couldn't swallow saliva/dysphagia, couldn't raise arm over shoulder/injection site movement impairment, tongue felt like it was numb/hypoaesthesia oral, and couldn't walk or stand up straight/gait inability were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/03/2021,02/04/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Dysphagia', 'Dyspnoea', 'Gait inability', 'Hypoaesthesia oral', 'Injection site induration', 'Injection site movement impairment', 'Injection site warmth', 'Limb discomfort', 'Paraesthesia', 'Tracheal inflammation']",1,MODERNA,OT 1051263,PA,71.0,F,"Passed away; Found unconscious; Coma; Lack of oxygen to the brain; A spontaneous report was received from a consumer, concerning his mother, a 71-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and passed away, prior to death, patient experienced lack of oxygen to the brain and was found unconscious and went to coma. The patient's medical history reported included seizures. Concomitant medications included phenobarbital, lamotrigine and levetiracetam. On 27 Jan 2021, approximately six days prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 01 Feb 2021 at 4 am, the patient was found to be unconscious on the couch, hence she was rushed to the hospital with lack of oxygen to the brain. Later, she went into a coma, hence she was in hospital for 30 hours and then was transferred to a different hospital for a second opinion on 06-Feb-2021, where she was passed away at 02:20 PM. Treatment information was not provided Action taken with mRNA-1273 in response to the events were not applicable. The outcome of events, lack of oxygen to the brain, found unconscious and coma were considered unknown. The outcome of event passed away was fatal as she died on 06 Feb 2021 at 2:20 pm. The cause of death was not provided. Plans for an autopsy were unknown.; Reporter's Comments: This is a case of 71-year-old female subject with a history of seizures who died 6 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Passed away",Yes,02/06/2021,Not Reported,Yes,,Not Reported,N,01/27/2021,02/01/2021,5.0,UNK,PHENOBARBITAL; LAMICTAL; KEPPRA,Seizures,,,,"['Brain hypoxia', 'Coma', 'Death', 'Loss of consciousness']",1,MODERNA,OT 1051264,KY,77.0,F,"Shortness of breath; Hemoglobin went from 8.8 to 8.2; oxygen level was at 82 whenever she is standing or walking; Sore arm; A spontaneous report was received from a consumer concerning a 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, sore arm, oxygen level at 82 when walking, and hemoglobin went from 8.8 to 8.2. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273(Lot number:039K20A) for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient experienced soreness in arm immediately after receiving the shot. The soreness resolved few days later. On 29 Jan 2021, Lab work done due to her being anemic and on perpetual oxygen therapy. Her hemoglobin level went down from 8.8 to 8.2 and her oxygen level was 82 on exertion. On 31 Jan 2021, the patient started experiencing shortness of breath. Patient stated that her saturation level was at 82 percent whenever she is standing up or walking and she runs out of breath. When she sits down, the level of the oxygen will go up. She said she is not sure if her medical condition is getting worse or if this is vaccine related Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events, shortness of breath, sore arm, oxygen level at 82 percent when walking, and hemoglobin went from 8.8 to 8.2 were unknown.; Reporter's Comments: Based on the information from the source document that the patient is an anemic patient on perpetual oxygen, the events of oxygen saturation decreased, hemoglobin decreased and dyspnea on exertion is assessed as unlikely related to mRNA-1273. The event of pain in extremity is possibly related. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/20/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No patient history reported.),,,"['Dyspnoea', 'Haemoglobin', 'Haemoglobin decreased', 'Oxygen saturation', 'Oxygen saturation decreased', 'Pain in extremity']",1,MODERNA,OT 1051265,IA,,F,"Vial was shaken before administration; A spontaneous report was received from a consumer concerning a 75-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the vial being shaken before administration/product dispensing issue. The patient's medical history was not provided. Concomitant medications were not provided. On an unknown date, the patient received her dose of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection. The patient's daughter called stating that the vial was shaken before being administrated. Treatment for this event was not reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, the vial being shaken before administration/product dispensing issue was recovered.; Reporter's Comments: This reports refers to a case of Product dispensing issue for mRNA-1273 (lot number unknown) with no associated AEs. Causality for the event is not applicable",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No adverse event history.),,,['Product dispensing issue'],1,MODERNA,OT 1051266,NY,,M,"urinary tract infection; Soreness in the shoulder; Kidney stone; Shoulder was black and blue; A spontaneous report was received from a consumer concerning a male patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection, soreness in the shoulder, shoulder was black and blue and kidney stone. The patient's medical history was not reported. Concomitant medication was not reported. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown dose, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient stated that he had a urinary tract infection after having the Moderna COVID-19 vaccine. The patient was given keflex but did not know if it would affect the vaccine. Patient had kidney stones two to three days before the second dose of the vaccine. Patient also reports a little soreness in the shoulder and that it was black and blue. He had the shot in his left arm and took Tylenol to help treat his symptoms. Action taken with second dose of mRNA-1273 in response to the event was not applicable. The outcome for the events urinary tract infection, soreness in the shoulder, shoulder was black and blue and kidney stone was unknown.; Reporter's Comments: Urinary tract infection is assessed as unlikely related to mRNA-1273 in the setting of newly diagnosed kidney stone. Based on the current available information and temporal association between the use of the product and the onset date of soreness in the shoulder and shoulder was black and blue, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Nephrolithiasis', 'Urinary tract infection', 'Vaccination site discolouration', 'Vaccination site pain']",2,MODERNA,OT 1051267,FL,72.0,M,"Passed away; Slight soreness in arm; A regulatory report was received from a pharmacist concerning a 72-year-old male patient who received Moderna covid-19 vaccine and death occurred 4 days after the vaccine and also experienced soreness in his arm after the vaccine administration. The patient's medical history includes diabetes mellitus, Hypertension, Hypercholesterolemia, CVD, previous stroke and Depression. No relevant concomitant medications were reported. No information on allergies. On 4-FEB-2021 at 10:43 am, prior to the onset of events, the patient received his first of two planned doses of covid-19 vaccine for the prophylaxis of covid-19 infection. He had soreness in his arm the day following the shot, but he had no other symptoms. He passed away on 08-FEB-2021 at 10 am. As per his wife, they never made it to the hospital, and he had poor health prior to vaccination. Action taken with 2nd dose of Moderna Covid-19 vaccine was not applicable. The outcome of the event death is fatal.; Reporter's Comments: This is a 72 year old male with hx of diabetes mellitus, hypertension, hypercholesterolemia, and CVD who died 4 days after the vaccine was administered. No autopsy report provided. No further information is expected in this regulatory report case.; Reported Cause(s) of Death: Unknown cause of death",Yes,02/08/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,UNK,,,"Medical History/Concurrent Conditions: Cardiovascular disease, unspecified; Depression; Diabetes mellitus; Hypercholesterolemia; Hypertension; Stroke (Previous stroke.)",,,"['Death', 'Injection site pain']",1,MODERNA,OT 1051268,WI,81.0,M,"Possible Stroke; Increase pressure and numbness in fingers; Headache; A spontaneous report was received from a pharmacist concerning an 81-year old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced possible stroke, face numbness, startled speech, increase pressure and numbness in fingers and headache. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included alprazolam and hydroxyzine. On 02 Feb 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) in the left arm for prophylaxis of Covid-19 infection. On unknown date, days after the vaccine was administered, the patient reported that he started having a headache, increased pressure and numbness in fingers. Patient had been having intermittent symptoms for 9 days. Patient was admitted to hospital on 10 Feb 2021 due to possible stroke. On 11 Feb 2021, the patient began to have startled speech and face numbness. Patient was evaluated by Neurology and an MRI was done. No further information was provided. Treatment for headache included Excedrin Migraine, ibuprofen and acetaminophen. Action taken with mRNA-1273 in response to the events were not reported. The outcome for the events possible stroke, face numbness, startled speech, headache, increase pressure and numbness in fingers, were considered as unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/02/2021,02/10/2021,8.0,UNK,XANAX; HYDROXYZINE,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Cerebrovascular accident', 'Headache', 'Hypoaesthesia']",1,MODERNA, 1051269,OH,69.0,F,"pneumonia; got Covid-19 after vaccinated; A spontaneous report was received from a consumer concerning a female patient of 69 year old, who was administered moderna's COVID-19 vaccine and tested positive for covid-19 and Experienced pneumonia. The patients medical history was not provided. No relevant concomitant medications were reported. On 06-JAN-2021, prior to the onset of events, the Patient received their first of two planned dose of Mrna-1273(Lot number: 012L20A) intramuscularly. On 11-JAN-2021,five days after receiving vaccine, the patient tested positive for covid-19 and had pneumonia. Patient was admitted in the hospital for five days of a ten day intravenous therapy and recently got home. Patient has one treatment left. Doctor said wait 90 days to get the second shot . Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events was not reported.; Reporter's Comments: This case concerns a 69-year-old female hospitalized with serious unexpected events of COVID-19 and COVID-19 pneumonia. Event onset 6 days after the first dose of mRNA-1273. Treated with 10 days of IV therapy. Very limited information regarding the events has been provided at this time. Further information has been requested. Based on the current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,01/06/2021,01/11/2021,5.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['COVID-19', 'COVID-19 pneumonia']",1,MODERNA,OT 1051270,ME,65.0,F,"Bells Palsy returned after recieving the Moderna COVID 19 vaccine; This spontaneous report was received from a Physician who phoned the call center regarding a 66-year-old female patient who received the Moderna COVID-19 (mRNA-1273) Vaccine and experienced a return of Bell's Palsy. The patient's medical history was reported as, ""having Bell's Palsy this past summer and it resolved"". Concomitant medications were not reported. On 25JAN2021, prior to the onset of the symptoms, the patient received her first of two planned doses of Moderna COVID-19 (mRNA-1273) Vaccine intramuscularly (Lot number: not provided). On 25JAN2021, the Physician reported, ""I have a patient who had Bells Palsy this past summer and it resolved. The patient had her first Moderna COVID 19 vaccine today and the Bells Palsy returned. Physician is not sure which arm the patient received the Moderna Covid-19 Vaccine in. Physician provides consent to Safety to contact regarding Adverse Event follow up"". The action taken for Moderna COVID-19 Vaccine was not reported. The outcome of the events, ""Bells Palsy returned after receiving the Moderna COVID 19 Vaccine"" was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient's medical history of having Bells Palsy this past summer (but it resolved) is a contributing factor. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/25/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Bell's palsy (Bells Palsy returned after receiving the Moderna COVID 19 Vaccine Patient had Bells Palsy this past summer (2020) and it resolved. The patient had her first Moderna COVID 19 vaccine 25JAN2021 and the Bells Palsy returned.),,,['Facial paralysis'],1,MODERNA,OT 1051271,NJ,64.0,F,"arm was very black and blue where the shot was administered and way around it/severe black and blue mark and bump like a golf ball on the arm where she got vaccinated; arm was very black and blue where the shot was administered and way around it/severe black and blue mark and bump like a golf ball on the arm where she got vaccinated; yeast infection from it; incredible arm pain/arm was really hurting bad; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), via an unspecified route of administration on 23Jan2021 at 12:00 at a single dose on the arm for COVID-19 immunization. The patient's medical history included high blood pressure. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that she was fine but on 23Jan2021 at 16:00, she experienced an incredible arm pain and fatigue. Her arm was really hurting bad. On 25Jan2021, the patient stated that her arm was very black and blue where the shot was administered and way around it. There was a severe black and blue mark and bump like a golf ball on the arm where she got vaccinated and had yeast infection from it. She never had this before since she never had a vaccine when she was a little kid. She wanted to know if they have heard about this before. She wanted to know if this was normal and if she needs go to the doctor. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient can't get appointment for second shot. The patient was not pregnant at the time of vaccination. The outcome of the events incredible arm pain and fatigue was recovering while the other events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/23/2021,0.0,UNK,SYNTHROID,,Medical History/Concurrent Conditions: Blood pressure abnormal,,,"['Fatigue', 'Fungal infection', 'Pain in extremity', 'Vaccination site discolouration', 'Vaccination site mass']",1,PFIZER\BIONTECH, 1051272,CT,45.0,F,"burning sensation in her right arm (not where she received the shot); This is a spontaneous report from a contactable consumer reporting for herself. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL3247/expiration date: not provided), via an unspecified route of administration, on 21Jan2021 10:15 (at the age of 45 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included birth control pills. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Jan2021 at 23:30, the patient experienced burning sensation in her right arm (not where she received the shot) late at night, lasting for about 20minutes. The patient did not receive any treatment for these events. The event did not require hospitalization. The outcome of the event burning sensation in her right arm (not where she received the shot) was recovered on an unspecified date in Jan2021. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/25/2021,4.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Burning sensation'],1,PFIZER\BIONTECH, 1051273,FL,74.0,F,"Hives; itching; shortness of breath; This is a spontaneous report from a contactable Other Health Professional, the patient. A 74-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number El1284), via an unspecified route of administration on 19Jan2021 at 16:00 (at the age of 74-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had unspecified concomitant medications that were received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021, the patient experienced hives, itching, all over and eventually some shortness of breath. The events resulted in visit to doctor or other healthcare professional office/clinic visit. The patient was treated for the events with prednisone and a variety of (unspecified) antihistamines. The patient was due to get the second dose of vaccination on Tuesday and the patient has been told she can get the second dose if she does it in the hospital under observation, and was requesting assistance in scheduling second vaccine. The clinical outcomes of the hives, itching, and shortness of breath were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Allergy (known allergies: Yes); Asthma,,,"['Dyspnoea', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH, 1051274,OH,92.0,F,"fever; chills; headache; fatigue; This is a spontaneous report from Pfizer via a contactable consumer (mother). A 92-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (at the age of 92-years-old), via an unspecified route of administration on 21Jan2021 as a single dose for covid-19 immunization. The patient has no medical history and Is not taking any concomitant medications. On 26Jan2021, she experienced fever, chills, headache, and fatigue. The clinical outcome of the events fever, chills, headache, fatigue was not recovered. Information on Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/26/2021,5.0,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Other Products: No",,,"['Chills', 'Fatigue', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH, 1051275,,,F,"""pins and needles"" sensation that happens ""on-and-off"" and soreness in the arm where she received the vaccination; ""pins and needles"" sensation that happens ""on-and-off"" and soreness in the arm where she received the vaccination; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program Support. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 25Jan2021 at a single dose on the arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced ""pins and needles"" sensation that happens ""on-and-off"" and soreness in the arm where she received the vaccination. She wanted to know if this is commonly reported and how long the soreness usually lasts. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,,,UNK,,,,,,"['Vaccination site pain', 'Vaccination site paraesthesia']",1,PFIZER\BIONTECH, 1051276,,,F,"she woke up and threw up; had diarrhea all day long; fever; tired; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 23Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported she had the first dose of the vaccine on Saturday (23Jan2021) at her school she works at; she did not feel any side effects that day. On 24Jan2021 she felt tired; and on 25Jan2021 she woke up and threw up, had diarrhea all day long and had a fever. She referred to her doctor who gave her ""something to stop the throwing up."" The patient was told by her doctor that only 1% experience her side effects and to contact Pfizer; the patient wanted to know if that was true and how long did the side effects typically occur. The clinical outcomes of tired, she woke up and threw up, had diarrhea all day long and fever were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,01/24/2021,1.0,SCH,,,,,,"['Diarrhoea', 'Fatigue', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH, 1051277,NY,96.0,F,"Tiredness; chills; leg weakness; confusion; This is a spontaneous report from a contactable consumer (patient). This 96-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 23Jan2021 at 12:15 PM (at the age of 96-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included atorvastatin from an unknown date for an unknown indication; atenolol from an unknown date for an unknown indication; losartan from an unknown date for an unknown indication; buspirone from an unknown date for an unknown indication; and ""levot"" from an unknown date for an unknown indication. The patient had not received any other vaccines in the four weeks prior to vaccination and did not have COVID prior to vaccination. On 25Jan2021 at 11:00 PM the patient experienced tiredness, chills, leg weakness, and confusion. The clinical outcomes of tiredness, chills, leg weakness and confusion were recovered in Jan2021. It was also reported the patient had not received a COVID test post-vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/25/2021,2.0,SEN,ATORVASTATIN; ATENOLOL; LOSARTAN; BUSPIRONE,,,,,"['Asthenia', 'Chills', 'Confusional state', 'Fatigue']",1,PFIZER\BIONTECH, 1051278,CA,68.0,F,"soreness at injection site; This is a spontaneous report from a contactable consumer. A 68-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via unknown route of administration in her left arm on 26Jan2021 (at the age of 68-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient did not have COVID. On 26Jan2021 the patient experienced soreness at injection site. The clinical outcome of soreness at injection site was recovered on an unspecified date. It was also reported the patient was not tested for COVID after vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1051279,,,F,"developed a rash 5 days after the vaccine; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated their wife developed a non-itching rash five days after the vaccine. The patient was prescribed prednisone and ""now"" (as of 26Jan2021) the rash was significantly less. The reporter inquired if the patient should get the second dose. The reporter also inquired about clinical trials; how many ""does"" was it before they reported side effects, and if the people in the clinical trials that reported rash as a side effect got the second dose. The clinical outcome of rash was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Rash'],1,PFIZER\BIONTECH, 1051280,CT,79.0,M,Feeling fatigued/unwell; Feeling fatigued/unwell; This is a spontaneous report from a contactable consumer (patient). This 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3248; dose 1) via an unspecified route of administration on 20Jan2021 at 15:00 (at the age of 79-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had an allergy to morphine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient experienced feeling fatigued and unwell on 21Jan2021. The event was reported as non-serious. The patient was not hospitalized for the event. The patient did not receive treatment for the event. The outcome of feeling fatigued and unwell was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/21/2021,1.0,UNK,,,,,,"['Fatigue', 'Malaise']",1,PFIZER\BIONTECH, 1051281,NM,32.0,F,"Noticed red blotchy rash around injection site 3cm in diameter; Noticed red blotchy rash around injection site 3cm in diameter; Her throat was feeling a little swollen without difficulty swallowing or breathing; This is a spontaneous report received from a contactable pharmacist (reporting for a patient). A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), intramuscular in the left arm on 25Jan2021 13:15 (at the age of 32-years-old) as a single dose for COVID-19 immunization. The patient's medical history was unknown. The patient had no known allergies. It was unknown if the patient had COVID prior to vaccination. It was unknown if the patient was pregnant at the time of vaccination. The patient's concomitant medication was unknown. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscular in the left arm on 04Jan2021 12:45 (at the age of 31-years-old) as a single dose for COVID-19 immunization; the patient had no reaction to the first dose. On 25Jan2021, the patient noticed a red blotchy rash around injection site 3 cm in diameter at 13:15. She was treated with diphenhydramine hcl (BENADRYL) 25 mg orally one dose. Her throat was feeling a little swollen without difficulty swallowing or breathing (also at 13:15 on 25Jan2021). She reported similar reactions to bee stings. At 13:25, the rash was almost gone, her throat was feeling better, and she ambulated independently to her vehicle. The clinical outcome of the events was recovered on an unspecified date in 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,PVT,,,,,,"['Pharyngeal swelling', 'Vaccination site erythema', 'Vaccination site rash']",2,PFIZER\BIONTECH,OT 1051282,AR,,F,"broke out in a sweat/very diaphoretic; the room turned a yellow color and she knew she was getting ready to pass out; the room turned a yellow color and she knew she was getting ready to pass out; blood pressure was lower than normal; This is a spontaneous report from a contactable nurse (parent reporting for her daughter). A 40-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date as a single dose for Covid-19 immunization. Medical history included allergic to bee stings and carries an EpiPen. The patient's concomitant medications were not reported. On an unspecified date, within the first 15 minutes of vaccination the patient broke out in a sweat and she had to lay down. They got her a coke and she felt a little better. The patient works in a dental office and 2.5 hours later, she was working on a patient in her dental office and she broke out in a sweat again, very diaphoretic, and the patient reported that the room turned a yellow color and she knew she was getting ready to pass out, but they took her in a room and put her in a reclining chair and let her stay there for 1 hour. They kept a wet towel on the patient's forehead. The caller said that they checked her daughter's blood pressure and it was lower than normal when checked. The patient was going to be receiving her second dose in an hour. The clinical outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Allergic reaction to bee sting (carries a EpiPen),,,"['Blood pressure decreased', 'Blood pressure measurement', 'Hyperhidrosis', 'Presyncope', 'Xanthopsia']",1,PFIZER\BIONTECH, 1051283,PA,33.0,F,"have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; numbness at times in her right foot; This is a spontaneous report from a contactable nurse reporting for herself. A 33-years-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EK9231, via an unspecified route of administration on 28Dec2020 16:45 (33 years old) as a SINGLE DOSE for COVID-19 immunization. Medical history included High blood pressure from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included sertraline, melatonin, colecalciferol (VITAMIN D), folic acid, iron (PRENATAL). The facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, has the patient has not been tested for COVID-19. On 07Jan2021, the patient experienced have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine. Patient also had some numbness at times in her right foot on 07Jan2021. She has not been able to see her primary care provider but has an appointment in Feb to be evaluated. The events were non-serious. No treatment was received for the events. Outcome of the events was not recovered. The patient received the second dose on 19Jan2021 in the Left arm lot EL3302.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/07/2021,10.0,PVT,SERTRALINE; MELATONIN; VITAMIN D; PRENATAL,,Medical History/Concurrent Conditions: Blood pressure high; COVID-19,,,"['Arthralgia', 'Back pain', 'Hypoaesthesia', 'Neck pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 1051284,CA,65.0,F,"My cheeks were red and hot.; My cheeks were red and hot.; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9263/expiration date: not provided), via an unspecified route of administration, on 23Jan2021 at 14:30 (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included allergic reaction to almonds and brewers yeast in Sep2019, being pre-diabetic, and osteoporosis. The patient had allergies to codeine (all forms), almonds, brewers yeast, mold and dust. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included metformin, alendronate sodium (FOSAMAX), and multivitamin, other supplement. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 at 15:15, the patient experienced that her cheeks were red and hot. The clinical course was as follows: because of a prior significant allergic reaction (Sep2019 determined to be primarily almonds and to a lesser extent brewers yeast), she waited 30 min. and she didn't notice anything until she left the property and removed her mask. Her cheeks were red and hot. She had a diphenhydramine (BENADRYL) tablet (OTC) which within 30+ min reversed it. The outcome of the events cheeks were red and hot was recovered on an unspecified date in 2021. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/23/2021,0.0,UNK,METFORMIN; FOSAMAX,,Medical History/Concurrent Conditions: Allergic reaction to food; Allergy to molds; Dust allergy; Food allergy; Osteoporosis; Pre-diabetic,,,"['Erythema', 'Feeling hot']",UNK,PFIZER\BIONTECH, 1051285,NM,32.0,M,"dizzy; foggy; diaphoretic; blurred vision; nausea; had one episode of vomiting; This is a spontaneous report from a contactable pharmacist. A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN5318/expiration date: not provided), via intramuscular route of administration, on 23Jan2021 12:00 (at the age of 32 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient did not have any known allergies. On 23Jan2021 at 12:00 immediately after the injection, the patient felt dizzy, foggy, diaphoretic, had blurred vision, nausea and had one episode of vomiting. The patient did not receive any treatment for these events. After the patient had emesis episode, the patient immediately returned to baseline and felt better. The patient stated that he normally had some type of reactions after injections. The patient was observed for a full 30 minutes and given water. 1225 patient check on and a this time had made a complete return to baseline. Patient discharge home after his full 30minute observation period ended at 1230. The outcome of the events dizzy, foggy, diaphoretic, had blurred vision, nausea and had one episode of vomiting was recovered 23Jan2021 at 12:30.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/23/2021,0.0,PUB,,,,,,"['Dizziness', 'Feeling abnormal', 'Hyperhidrosis', 'Nausea', 'Vision blurred', 'Vomiting']",1,PFIZER\BIONTECH,OT 1051286,WA,37.0,M,"Severe puffiness of eyes.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number E69263), via an unspecified route of administration in the right arm on 25Jan2021 at 09:15 (at the age of 37-years) as a single dose for Covid-19 immunization. Historical vaccine included the first dose of BNT162B2 (Lot Number E61284) on 04Jan2021 at 09:00 (at the age of 37-years) in the right arm for Covid-19 immunization. The patient's medical history and concomitant medications was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 26Jan2021 11:45, the patient experienced severe puffiness of eyes. The patient was seen in emergency department or urgent care. The patient was treated for the severe puffiness of eyes with diphenhydramine hydrochloride (BENADRYL). The clinical outcome of the event severe puffiness of eyes was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,MIL,,,,,,['Eye oedema'],2,PFIZER\BIONTECH, 1051287,NY,36.0,F,"12 hours after redness and heat on hand and elbow on the left side; 12 hours after redness and heat on hand and elbow on the left side; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 26Jan2021 at 07:30 (at the age of 36-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no medical history. Concomitant medications included caffeine/paracetamol (EXCEDRIN), paracetamol (TYLENOL) and ergocalciferol (VIT D). Past drug history included known allergies: cefaclor (CECLOR) and sulfamethoxazole/trimethoprim (SEPTRA). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 26Jan2021 at 19:30, 12 hours after vaccination, the patient experienced redness and heat on hand and elbow on the left side. Treatment included applied Burts Bees lotion on hand and elbow for the event redness and heat. The outcome of the event redness and heat was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,PVT,EXCEDRIN [CAFFEINE;PARACETAMOL]; TYLENOL; VIT D,,,,,"['Erythema', 'Feeling hot']",1,PFIZER\BIONTECH,OT 1051288,NC,,F,"She felt fine aside from a sore arm at the site; This is a spontaneous report based on the information received by Pfizer from Merck & co, inc (Ref Case Number: 01838313). A contactable other healthcare professional reported for a female patient of unspecified age (her friend/nurse) received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that her friend, who is a nurse, posted on 06Jan2021 that she had gotten her first dose of the vaccine (date of administration unspecified) and then later in a text message said she felt fine aside from a sore arm at the site on an unspecified date. Outcome of the event was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,,,UNK,,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1051289,MA,28.0,F,"Sore arm/arm felt sore; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: EL3247), via intramuscular route of administration, on 26Jan2021 10:15 AM (at the age of 28 years old) as a single dose in the left arm for COVID-19 immunization at work clinic. Relevant medical history were anxiety, depression. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), aripiprazole (ABILIFY), iron, ascorbic acid (VITAMIN C). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 at 04:00 PM, the patient experienced sore arm/arm felt sore. No treatment was received for the event arm/arm felt sore. The outcome of the event arm/arm felt sore was recovering. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,WRK,PROZAC; WELLBUTRIN; ABILIFY; IRON; VITAMIN C [ASCORBIC ACID],,Medical History/Concurrent Conditions: Anxiety; Depression,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1051290,KY,50.0,F,"Throbbing arm pain; Fever; Chills; Body aches; Headache; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), intramuscular in left arm, on 18Dec2020 at 09:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history included asthma, chronic back pain (surgery and scoliosis), migraines, systemic reaction to allergy injection, and COVID-19 in Jun2020 (prior vaccination). The patient's concomitant medications included pregabalin (LYRICA), butalbital, ascorbic acid (VITAMINS C), biotin, boron/ calcium/ Cimicifuga racemosa extract/ folic acid/ Glycine max extract/ Magnolia officinalis/ nicotinic acid/ pyridoxine hydrochloride/ riboflavin/ selenium/ thiamine/ tocopherol/ vitamin B12 NOS (ESTROVEN), Linum usitatissimum seed oil (FLAXSEED OIL), paracetamol (TYLENOL ARTHRITIS), and an unspecified stool softener and D (unspecified). The patient previously took amoxicillin and cinnamon oil and experienced allergies to both. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 18Dec2020 at 08:00 PM, the patient experienced throbbing arm pain for 2 days, fever, chills, body aches, headache, and fatigue for 2 days - some of the same symptoms she had when she had COVID-19 back in Jun2020. The events were considered non-serious. Treatment was received for the adverse events including ibuprofen, paracetamol (TYLENOL), and famotidine/ ibuprofen (DUEXIS). Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from ""Throbbing arm pain"" and ""Fatigue"" on 20Dec2020, and from the remaining events on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/18/2020,12/18/2020,0.0,PVT,LYRICA; BUTALBITAL; VITAMINS C; BIOTIN; ESTROVEN; FLAXSEED OIL; TYLENOL ARTHRITIS,,Medical History/Concurrent Conditions: Asthma; Back surgery; Chronic back pain; COVID-19 (Prior vaccination); Migraine; Scoliosis; Systemic allergic reaction,,,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH,OT 1051291,,78.0,F,"she was ""Just not feeling myself - nothing I can even describe in detail, just vaguely not myself; Did not want supper; This is a spontaneous report received from a non-contactable consumer (patient herself). A 78-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: Not available), via an unspecified route of administration on 23Jan2021 to 23Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient reported that on Monday (2 days post-vaccine on 25Jan2021) she was ""Just not feeling myself - nothing, she can even describe in detail, just vaguely not myself. Did not want supper so had scrambled eggs and toast and went to bed early. Woke up feeling fine. She hardly ever felt other than fine and she could not think of anything other than the vaccine on Saturday that was unusual. On Sunday, she felt fine and today she feel fine"". Treatment was not received for the events. The outcome of the events was recovered on Jan2021. No follow-up attempts are possible; Information about lot/ batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/25/2021,2.0,PUB,,,,,,"['Decreased appetite', 'Feeling abnormal']",1,PFIZER\BIONTECH, 1051292,,56.0,M,"pt is a type 1 diabetic- increase in blood glucose above the norm despite insulin for a period of ~ 6hours; This is a spontaneous report from a non-contactable consumer. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration at the age of 56 years on 26Jan2021 at a SINGLE DOSE for covid-19 immunisation . Medical history included diabetes mellitus from an unknown date and unknown if ongoing type 1 diabetic. The patient's concomitant medications were not reported. The patient has a history of type 1 diabetes and had increase in blood glucose above the norm despite insulin for a period of 6hours on Jan2021. The patient underwent lab tests and procedures which included blood glucose: increase on Jan2021. No treatment was received for the event. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Diabetic (type 1 diabetic),,,"['Blood glucose', 'Blood glucose increased']",UNK,PFIZER\BIONTECH, 1051293,OH,66.0,F,"I have a fever of 100.3, is that normal; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 26Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient stated, ""I have a fever of 100.3 F, is that normal in Jan2021."" The outcome of the event fever was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/01/2021,,UNK,,,,,,"['Body temperature', 'Pyrexia']",1,PFIZER\BIONTECH,OT 1051294,AR,,M,"fever/Her dad was running a fever of a 102.9; tiredness; cough; headache; muscle pain; chills; joint pain; her father was feeling unwell; my dad was feeling nausea too; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's daughter) reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9262), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, caller mentioned that both her parents got the first dose of the COVID-19 vaccine and afterwards they got fever, tiredness, cough, headache, muscle pain, chills, joint pain, and her father was feeling unwell on an unspecified date in 2021. She wanted to know how many days do these side effect would last and also how to treat them. She was aware that this has been reported in the clinical trials. She has already got doctors but got no answers. This is the first case out of two cases. Transferring agent stated, ""I have a caller on the line. She was calling about her parents. Her parents received the dose of Pfizer COVID vaccine on 20Jan2021. Her dad was running a fever of a 102.9 and her mother was running a fever of 101 on an unspecified date in 2021. So, she was kind of wondering how long this might last. I did give her the medical information department phone number, but I am getting her over to you to record the fever."" When paraphrased the concern, reporter stated, ""Yes, and what was the procedure to prevent it because they had the Pfizer vaccine and they have all the symptoms to them except not injection site redness and nausea. But my dad was feeling nausea too on an unspecified date in 2021."" The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,,,UNK,,,,,,"['Arthralgia', 'Body temperature', 'Chills', 'Cough', 'Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH, 1051295,AZ,58.0,F,"had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that arm; left arm she was vaccinated on was incredibly sore; left arm she was vaccinated on was incredibly sore, swollen; Patient do have autoimmune issues; Patient do have autoimmune issues; numbness and pain in my left hand; getting pins and needless; left wrist is a little swollen; whole arm hurts, including elbow joint, and shoulder joint; headache; chills; maybe slight fever, never took my temperature; body aches all over; kind of muscle weakness in her whole arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 11:49 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, rheumatoid arthritis, rosacea, periarthritis and frozen shoulder prior a little over a year ago. The patient's concomitant medications were not reported. Patient was vaccinated on Thursday morning, and her left arm she was vaccinated on was incredibly sore, swollen, she has pins and needles, her hand was going numb, she has a lot of pain, and kind of muscle weakness in her whole arm and it hurts to touch her arm still on Jan2021. The initial side effects in her left arm at injection site. The injection site symptoms started within an hour of getting it at 11:49 am on 21Jan2021. Patient received the vaccine and probably around 1pm on 21Jan2021 in the afternoon it was really sore, and had trouble raising her arm, and it hurts to touch the upper part of that arm. The pain was not exactly at the injection point, it's just below, where it hurts. On Jan2021, patient was getting pins and needless and numbness and pain in her left hand. It's like it's swollen, it has that tight swollen feel to it, even though it doesn't look like it, although her left wrist is a little swollen on Jan2021. Her whole arm hurts, including elbow joint, and shoulder joint. Once patient got the vaccine, it all of a sudden exacerbated what ever was going on. She was doing good until she got the injection, and now she feel like,it's gone backwards and has effected the muscles in her arms now. Patient do have autoimmune issues. She also had headache, chills, maybe slight fever, never took my temperature, body aches all over, joints hurt incredibly bad on Jan2021. Most effects were gone away, mostly concerned about the arm. Her concern was the arm. Outcome of the events was unknown. Patient was asking if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The reporter considered the events non-serious. Information on lot/batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Fibromyalgia; Frozen shoulder; Rheumatoid arthritis; Rosacea,,,"['Arthralgia', 'Chills', 'Headache', 'Hypoaesthesia', 'Joint swelling', 'Muscular weakness', 'Off label use', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Product use issue', 'Pyrexia', 'Vaccination site movement impairment', 'Vaccination site pain', 'Vaccination site swelling']",UNK,PFIZER\BIONTECH, 1051296,KS,54.0,M,"Arm soreness at injection site; fatigue; slight muscle aches in neck/shoulders; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN 5318 and expiration date unknown), via an unspecified route of administration on left arm at the age of 54 years old on 26Jan2021 at 08:30 AM at a single dose for COVID-19 immunisation at the workplace clinic. Medical history included hypertension and pre-diabetic. Allergies to medications, food, or other products was none. Concomitant medications included metoprolol tartrate, atorvastatin and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced arm soreness at injection site, fatigue, slight muscle aches in neck/shoulders on 26Jan2021 at 05:00 PM. The patient assessed the events as non-serious. No treatment was received in response to the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,WRK,METOPROLOL TARTRATE; ATORVASTATIN,,Medical History/Concurrent Conditions: Hypertension; Pre-diabetic,,,"['Fatigue', 'Myalgia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1051297,FL,71.0,F,"nose felt tingly front teeth and right side of my tongue felt numb; nose felt tingly front teeth and right side of my tongue felt numb; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL 9263), via an unspecified route of administration in left arm on 22Jan2021 16:15 at single dose for COVID-19 immunisation. The patient's medical history included diabetes, high cholesterol, thyroid, allergies: Sulfites in foods and drugs, allergies: Penicillin. Concomitant medications included metformin at 800 mg, twice a day and levothyroxine sodium (LEVOTHYROXIN) at 75mg, once a day. The patient previously took sulfur and experienced allergies: sulfur. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 22Jan2021, at 16:15, the patient reported nose felt tingly front teeth and right side of my tongue felt numb. The patient carries an epi pen for an allergic reaction as the patient have to sulfites in foods and drugs (sulfur and penicillin allergies). The patient did not have to call for help or use epi-pen but was concerned somewhat for the second dose in 19 days. The events was considered as non-serious by the consumer. When the patient went home about 15 minutes later still felt this, hence the therapeutic measures were taken as a result of events included treatment with 2tbl Benadryl and 1/2 Zertex and within 30 minutes the patient was ok. The outcome of the events was recovered on an unspecified date in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,UNK,METFORMIN; LEVOTHYROXIN,,Medical History/Concurrent Conditions: Diabetes; High cholesterol; Penicillin allergy; Reaction to sulfites; Thyroid disorder,,,"['Hypoaesthesia oral', 'Intranasal paraesthesia']",1,PFIZER\BIONTECH, 1051298,WA,89.0,F,"Dizzy; This is a spontaneous report from a contactable consumer, the patient. This 89-year-old female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 , single dose via unknown route of administration in the left arm on 25Jan2021 at 13:00 (at the age of 89 years-old) for COVID-19 vaccination. Medical history included chronic obstructive pulmonary disease (COPD) diagnosed in 2016 and she never smoked in her life, it was second hand smoke, congestive heart failure diagnosed in 2015 and is hard of hearing several years back, she has had hearing aids for a long time, but they don't do any good. Concomitant medications included an unspecified flu shot. She was dizzy the night of 25Jan2021 and all day on 26Jan2021. The clinical outcome of dizzy was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/25/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Congestive heart failure; COPD; Hard of hearing,,,['Dizziness'],1,PFIZER\BIONTECH, 1051299,NC,,F,"sore arm; fast heartbeats like 110; weakness; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient experienced sore arm, fast heartbeats like 110, tightness, and weakness. Outcome of the sore arm was recovered on Jan2021 after 2 days while of the remaining events was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/01/2021,,UNK,,,,,,"['Asthenia', 'Heart rate', 'Heart rate increased', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 1051300,MN,69.0,F,"Lightheaded or dizzy; Dry heaves; Very warm; Charley horses in both legs; Chills; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302), via an unspecified route of administration in right arm, on 26Jan2021 at 13:15 (01:15 PM), at a single dose, for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease (COPD). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a doctor's office or urgent care facility. On 26Jan2021 (reported as 12:15 AM; pending clarification), the patient woke up lightheaded or dizzy, with dry heaves, very warm, and with Charley (reported as Charlie) horses in both legs, then she got the chills. This morning (27Jan2021), the patient felt fine. No treatment was administered for the adverse events. The patient was not tested for COVID-19 post vaccination. The patient recovered from the events on 27Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,OTH,,,Medical History/Concurrent Conditions: COPD,,,"['Chills', 'Dizziness', 'Feeling hot', 'Muscle spasms', 'Retching']",UNK,PFIZER\BIONTECH, 1051301,NC,51.0,F,"Exhausted; Night terrors; This is a spontaneous report from a contactable consumer, the patient. This 51year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248), DOSE 1, single dose via unknown route of administration in the left arm on 25Jan2021 about 3:45pm (at the age of 51 years-old) for COVID-19 vaccination. Medical history included ongoing severe asthmatic onset date unknown, probably during childhood but worsened with age and became really bad after hurricane, ongoing irregular heartbeat, ongoing menopause, ongoing food allergies includes banana peppers, jalepenos and nuts; anything spicy; these cause anaphylactic reactions where her throat is itching and swells, ongoing Hashimoto's disease, thyroid, endocrine abnormality and compromises immune system, to keep her brain going through menopause, seizure disorder and high blood pressure. Past drug events included Demerol-Vistaril: ate part of her leg away, top layer of her leg just fell off; she had all the skin done and had plastic surgery to repair this in 1988; Lot/NDC/Expiry: Unknown, does not have product, anaphylactic reactions to: penicillin: Lot/NDC/Expiry: Unknown, does not have product; clindamycin: Lot/NDC/Expiry: Unknown, does not have product; sulfa: Lot/NDC/Expiry: Unknown, does not have product; Darvocet: Lot/NDC/Expiry: Unknown, does not have product; Ceclor: Lot/NDC/Expiry: Unknown, does not have product. There was no family medical history relevant to events, night terrors and exhausted. Concomitant medications included atenolol 12.5mg taken once daily (1/2 of 25mg tablet) for irregular heartbeat, levothyroxine 125mcg taken once daily for thyroid, bupropion (WELLBUTRIN) 300mg taken once daily for menopause, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 20mg extended release taken once daily to keep her brain going through menopause, topiramate (TOPAMATE) 25mg taken once daily for seizure disorder and lisinopril 10mg taken daily for high blood pressure. On 26Jan2021, the patient had night terrors where she started screaming in her sleep at midnight and was exhausted at 05:00 and ongoing. There were no relevant tests. The night terrors and exhausted did not require a visit to the physician's office or emergency room. The clinical outcome of night terrors was recovered with sequel and not recovered for exhausted. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): None.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,SCH,ATENOLOL; LEVOTHYROXINE; WELLBUTRIN; ADDERALL; TOPAMATE; LISINOPRIL,"Asthmatic (Asthma onset date unknown, probably during childhood but worsened with age and became really bad after hurricane.); Drug allergy; Food allergy ( ~~~); Hashimoto's disease (Endocrine abnormality and compromises immune system.); Heartbeats irregular; Menopause; Penicillin allergy",Medical History/Concurrent Conditions: Blood pressure high; Memory impairment; Seizure; Thyroid disorder,,,"['Fatigue', 'Sleep terror']",1,PFIZER\BIONTECH, 1051302,FL,,F,"redness at injection site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first dose on 14Jan2021. It was reported that the patient experienced redness at injection site on an unspecified date and it maintains. The patient asked if she should get it in opposite arm on 04Feb2021. The outcome of event was not recovered. Information on lot/batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,,,UNK,,,,,,['Vaccination site erythema'],1,PFIZER\BIONTECH, 1051303,TX,69.0,M,"his arm is starting to sore.; arm started getting sore where he received the injection; This is a spontaneous report from Pfizer via a contactable consumer (mother). A 69-year old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (at the age of 69-years-old), via an unspecified route of administration on 25Jan2021 as a single dose for covid-19 immunization. The patient has no medical history and Is not taking any concomitant medications. On 25Jan2021, he experienced his arm is starting to sore and about an hour after that his arm started getting sore where he received the injection. He states that he took two Tylenol and by the next morning his arm was feeling totally better. He states that he had no other symptoms. The clinical outcome of the event his arm started getting sore was recovering; the outcome of sore where he received the injection was unknown. Information on Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,UNK,,,,,,"['Pain in extremity', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1051304,MI,71.0,F,"Chest pain and pressure; Chest pain and pressure; Numbness on left jaw, arm and hand; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 71-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration in right arm on 23Jan2021 13:45 at single dose for COVID-19 immunisation in facility type other. The patient's medical history included asthma, unspecified auto immune, sickle cell trait, reflux. The patient have allergies to medications, food, or other products. Concomitant medications included nifedipine (CELEBRATE) at 200 mg, mirtazapine at 7.5 mg, vitamin b12, ascorbic acid (VITAMIN C). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 23Jan2021 04:00 AM, the patient experienced chest pain and pressure, numbness on left jaw, arm and hand. The adverse events result in emergency room/department or urgent care. The events were considered as non-serious by the other healthcare professional. The patient did not receive treatment for the adverse events. The outcome of the events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/23/2021,0.0,UNK,CELEBRATE; MIRTAZAPINE; VITAMIN B12 [VITAMIN B12 NOS]; VITAMIN C [ASCORBIC ACID],,"Medical History/Concurrent Conditions: Allergy (Allergies to medications, food, or other products:Yes); Asthma; Autoimmune disorder NOS; Gastrooesophageal reflux disease; Sickle cell trait",,,"['Chest discomfort', 'Chest pain', 'Hypoaesthesia']",1,PFIZER\BIONTECH, 1051305,TX,81.0,F,"check her own self with her hand and it was like she put her hand on a stove; Allergic reaction; felt bad after taking the first dose-flu like symptoms /achy like flu symptoms; had high fever/feverish; urine became yellowish-brown; had a little diarrhea symptoms; get sick; vomiting; has a really bitter taste, or no taste in her mouth/ her mouth still has that nasty, old bitter taste that does not go away with brushed teeth; has a really bitter taste, or no taste in her mouth/ her mouth still has that nasty, old bitter taste that does not go away with brushed teeth; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program Pfizer First Connect. An 81-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; manufacturer reported as Pfizer-Wyeth; lot number: EL1283; expiration date: unknown), via an unspecified route of administration left arm on 21Jan2021 12:30 at 0.3 mL, single dose for covid-19 immunization. Medical history included arthritis in back; always had diarrhea because she had cancer and is unable to control her bowels. They tell her she has a lot of fiber in her food; but she can't control it; if she eats vegetables then she knows what's happening; but she always tries to take Imodium A-D before eating vegetables. She mentioned to them if she did not eat vegetables all she could eat is meat and cheese; doctor told her she was borderline diabetic, so she has wanted to keep up with that. The doctor was not worried about it; ongoing acid reflux; pain; and ongoing high blood pressure. Concomitant medication included ongoing omeprazole for acid reflux, ongoing amlodipine for high blood pressure, naproxen for arthritis in back, caffeine, codeine phosphate, paracetamol (ACETAMINOPHEN WITH CODEINE) for pain, loperamide hydrochloride (IMODIUM A-D) for diarrhea. The patient has not received any other vaccinations within four weeks prior to the first administration of the covid-19 vaccine. Vaccinations reported as she has gotten flu shots and pneumonia shot and has never had any adverse events, reactions or problems with those; nothing. The reporter mentioned that she got her first dose of the vaccine in a clinic on 21Jan2021 and aware that the second dose will be on 16Feb2021. The patient reported that she felt bad after taking the first dose-flu like symptoms on 23Jan2021 at 8:00 and had high fever Saturday (23Jan2021), urine became yellowish-brown and wants to know more information. The patient guesses she is having an allergic reaction on 23Jan2021 at 8:00 and asked for further information about the allergic reaction relative to the vaccine. On Saturday (23Jan2021), she was feeling good. She got up, went to store, came back and had little diarrhea symptoms then she began to get sick, feverish. She added that then the vomiting, then achy like flu symptoms. She still feels feverish, she has a really bitter taste, or no taste in her mouth really but it's going away. To her it seems like the worst part is over. She almost called 911 but then did not want to go the hospital because of all the people with COVID in the hospital. The next day on 24Jan2021, when she woke up, she was not as fevered. She can check her own self with her hand and it was like she put her hand on a stove. She went to sleep and the next morning (24Jan2021), she was not as feverish; her mouth still has that nasty, old bitter taste that does not go away with brushed teeth. She feels better today (unspecified date). She mentioned that the second dose is scheduled to be administered 16Feb2021, but she really does not want to go get that if she feels like this. She had blood work for her sugar done on 21Jan2021 because she is borderline diabetic, but results are unknown, have not had any results yet. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/23/2021,2.0,OTH,OMEPRAZOLE; AMLODIPINE; NAPROXEN; ACETAMINOPHEN WITH CODEINE; IMODIUM A-D,Acid reflux (esophageal); Blood pressure high,Medical History/Concurrent Conditions: Cancer (always had diarrhea because she had cancer and is unable to control her bowels); Diabetic (MD told her she's borderline diabetic. MD was not worried about it); Diarrhea (always had diarrhea because she had cancer and is unable to control her bowels); Pain; Spondylitis,,,"['Ageusia', 'Blood test', 'Body temperature', 'Chromaturia', 'Diarrhoea', 'Dysgeusia', 'Feeling hot', 'Hypersensitivity', 'Illness', 'Influenza like illness', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH, 1051306,NJ,52.0,F,"lost taste and smell; lost taste and smell; This is a spontaneous report from a contactable nurse (patient herself). A 52-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 04Jan2021 10:45, at single dose, for covid-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), on an unspecified date, at single dose, for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The vaccine was administered in the hospital. 3 weeks after the 2nd dose, on 27Jan2021 the patient lost taste and smell. Her PCR nasal Covid swab was negative on 27Jan2021. The patient had not recovered from the adverse events. No treatment was received for the adverse events. Information about the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/27/2021,23.0,PVT,,,,,,"['Ageusia', 'Anosmia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1051307,,,F,"pain in the injection site/a little bit of pain at the injection site; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) on an unspecified date then the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), on 24Jan2021 - both via an unspecified route of administration, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient just received the 2nd dose of the Covid-19 Vaccine yesterday morning (also reported as around noon time), 24Jan2021. The patient stated she was fully aware of the other side effects, but she was not experiencing those other than pain in the injection site on Jan2021. She added she was not experiencing any of the effects that she was told that she should and with other people she knew who have gotten the vaccine that they have. The only thing that she had was a little bit of pain at the injection site which was what she also had on an unspecified date after the first shot on an unspecified date. She stated she had nothing, no fever, no chills, no headache; nothing that they said she should be experiencing. She then asked if that meant it was not working. She wanted to know more information about herself and if she was immune to those. The outcome of the event was unknown. Information about the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1051308,WI,18.0,F,"Throwing up; vomited 4 times; Chills; Headache; Fever; highest temperature was 101.4 degrees; low-grade temperature; Nausea; Stomach was not feeling right; upset stomach; This is a spontaneous report from a contactable consumer (patient's mother who is a caregiver). An 18-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in right arm, on 26Jan2021 at 07:30, at a single dose, for COVID-19 immunization. The patient's medical history included birth control pill. The patient's concomitant medication included ethinylestradiol/ norgestrel (CRYSELLE) from 26Jan2021 as birth control pill. The patient previously took the first dose of BNT162B2 on 05Jan2021 at 08:00 AM for COVID-19 immunization (in right arm). The vaccine was administered in a hospital facility. The patient was a certified nursing assistant (CNA) at a hospital. The patient and her mother both work at the same hospital that administered their COVID-19 vaccines, both received the first and second COVID-19 vaccines at the same date and time. The patient received her second COVID-19 vaccine dose yesterday (26Jan2021). Since 26Jan2021 around 09:00 PM, the patient was experiencing symptoms of chills, headache, fever, and nausea. The patient had a fever, clarifying that the highest temperature was 101.4 degrees, and also has chills and headache. Last night (26Jan2021 at 09:00 PM), the patient's stomach was not feeling right, had a low-grade temperature, and chills. On this morning (27Jan2021), the patient was throwing up. The patient didn't throw up until this morning and has vomited 4 times today. The patient has not sought medical treatment from an emergency room or doctor yet. The patient has been throwing up today. If the patient continues throwing up, and becomes dehydrated, she may need to go the emergency room. It was also reported that the patient started ethinylestradiol/ norgestrel last night. The patient's mother thought that the patient's initial stomach upset may have been caused by the ethinylestradiol/ norgestrel. Therapeutic measures were taken as a result of headache and fever including ibuprofen and acetaminophen; the patient isn't taking anything for nausea at this time. The patient's mother wanted to see if anyone else had been reporting these side effects the patient has been experiencing since receiving her second COVID-19 vaccine dose. The patient had not recovered from the events. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,PVT,CRYSELLE,,Medical History/Concurrent Conditions: Birth control pill,,,"['Abdominal discomfort', 'Body temperature', 'Chills', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,OT 1051309,,,F,"fever; small rash just below the injection site; chills; achy shoulders; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 14Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated, 6 days after the first dose (20Jan2021) she has had a fever for 2 days, small rash just below the injection site, chills, achy shoulders. She was wondering if this should be happening 6 days after first dose. The outcome of the event fever was recovered on 22Jan2021 while other events were unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/20/2021,6.0,UNK,,,,,,"['Arthralgia', 'Chills', 'Pyrexia', 'Vaccination site rash']",1,PFIZER\BIONTECH, 1051310,,,F,"she experienced hand and feet itching/her arm is itchy; she noticed red streaks and splotches going up her arm to her elbows; she noticed red streaks and splotches going up her arm to her elbows; her arm started stinging; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she received the first dose of the vaccine on 13Jan2021 and after the vaccine, she experienced hand and feet itching that lasted a few days in Jan2021. On Thursday and Friday after receiving the vaccine, she took Benadryl and put Cortisone on her hands. She then went to her doctor who prescribed her a medication and the Pharmacist told her it was Benadryl. She took the medication for 5 days and the medication stopped the itching. Today (as reported), her hands were itchy and she noticed red streaks and splotches going up her arm to her elbows and her arm was itchy, in Jan2021. Her arm started stinging as well while working at the dentist office today (as reported). Patient would like to know if she should receive the second dose as she was scheduled to receive the second dose on 03Feb2021. Outcome of events was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/01/2021,,UNK,,,,,,"['Erythema', 'Pain in extremity', 'Pruritus', 'Rash macular']",1,PFIZER\BIONTECH, 1051311,CT,45.0,M,"moderate fatigue/tiredness; some difficulty concentrating; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL 3247, expiry date unknown) in the workplace clinic, via an unspecified route of administration on 26Jan2021 at 13:45 at a single dose on the left arm for COVID-19 immunization. The patient had no medical history and no known allergies. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that on 27Jan2021 at 06:45, the morning after the patient was vaccinated, he had moderate fatigue/tiredness with some difficulty concentrating. The patient stated that it felt similar to getting 2-3 hour sleep, but he had no issue sleeping last night. The patient did not receive treatment for the event. The patient was recovering from the events. The events were reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Disturbance in attention', 'Fatigue']",1,PFIZER\BIONTECH, 1051312,,,F,"migraine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter wanted to know if the patient could take Sudafed PE for a migraine that she was experiencing from an unspecified date. The patient received the first dose of the vaccine yesterday afternoon (26Jan2021), in which her doctor recommended her to not take ibuprofen within the first 24 hours of the vaccine. The outcome of event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,,,UNK,,,,,,['Migraine'],1,PFIZER\BIONTECH, 1051313,TX,32.0,M,"Loss of taste and smell; Loss of taste and smell; nausea; headache; This is a spontaneous report from a contactable nurse (patient himself). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscularly on the left arm on 25Jan2021, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number known but not reported) on an unspecified date for covid-19 immunization. The patient experienced loss of taste and smell, nausea, and headache - all on 26Jan2021. No treatment was received for the adverse events. At the time of the report, the patient had not recovered from the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient had a nasal swab for Covid-19 on 26Jan2021 with results of negative. Information about the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,UNK,,,,,,"['Ageusia', 'Anosmia', 'Headache', 'Nausea', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,OT 1051314,CO,76.0,M,"Sore arm at the injection site; Exhaustion; Achy body; Low-grade fever; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 26Jan2021 14:30 at single dose for Covid-19 immunization administered at Hospital. The patient's medical history Have a stent in my heart, mild heart attack 2+ years ago, and Covid-19. The patient's concomitant medication included acetylsalicylic acid (BABY ASPIRIN) at 83 mg, metoprolol, and evolocumab (REPATHA). On 26Jan2021 21:30, the patient experienced Sore arm at the injection site, exhaustion, achy body, low-grade fever. The patient did not received treatment for the events. The reporter assessed the events as non-serious. The outcome of the events was recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,PVT,BABY ASPIRIN; METOPROLOL; REPATHA,,Medical History/Concurrent Conditions: Coronary arterial stent insertion; COVID-19; Heart attack (mild heart attack 2+ years ago),,,"['Fatigue', 'Pain', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1051315,KY,39.0,M,"Experienced flu-like symptoms and a temperature of 102 the evening after receiving the second dose of the COVID-19 vaccine; Experienced flu-like symptoms and a temperature of 102 the evening after receiving the second dose of the COVID-19 vaccine; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative. A 39-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration at the age of 39 years, on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced flu-like symptoms and a temperature of 102 the evening after receiving the second dose of the COVID-19 vaccine on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 102 on an unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Body temperature', 'Body temperature increased', 'Influenza like illness']",2,PFIZER\BIONTECH, 1051316,CT,45.0,M,"Headache; pain in left arm; This is a spontaneous report from a contactable consumer (patient himself). A 45-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL 3247), via an unspecified route of administration in left arm on 27Jan2021 11:15 AM at single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medications included PROBIOTIC and colecalciferol (VITAMIN D). The patient have not been tested for COVID-19 since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 12:00 PM, the patient experienced headache and pain in left arm. The patient did not receive treatment for the adverse events. The events were considered as non-serious by the consumer. The outcome of the events was recovered on an unspecified date in 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,WRK,VITAMIN D [COLECALCIFEROL],,,,,"['Headache', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1051317,FL,,U,"Felt awful like they had the flu; Felt awful like they had the flu; This is a spontaneous report from a contactable consumer through a Pfizer-sponsored program. This consumer reported similar events for three patients. This is the second of the three reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy dates unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had felt awful like having the flu. The outcome of the events, 'felt awful like having the flu', was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082187 same reporter/product/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Feeling abnormal', 'Influenza like illness']",UNK,PFIZER\BIONTECH, 1051318,,,F,"began shivering; This is a spontaneous report from a non-contactable consumer. A 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 25Jan2021 at 09:00 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medications were not reported. On 25Jan2021 at 16:30, the patient began shivering. Putting on another layer of clothing alleviated the problem. It was also reported that the patient's husband had forgotten to turn up the heat that morning so the house was colder than usual. The clinical outcomes of shivering was unknown. No follow-up attempts are possible; information about lot number cannot be obtained. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/25/2021,0.0,UNK,,,,,,['Chills'],UNK,PFIZER\BIONTECH, 1051319,MO,32.0,F,"some very pain/soreness at the injection site; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient receive the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN 5318, expiry date: 31May2021), via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that in the morning on 27Jan2021, the patient experienced some very pain/soreness at the injection site but was less intense than what the experienced with a non-Pfizer influenza shot on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/27/2021,1.0,OTH,,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1051320,CT,39.0,F,"Something stuck in my throat; Nausea; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported) on 22Dec2020 (12:30) at a single dose on the left deltoid, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included allergy to lobster, and had used steroids. The patient's concomitant medications were not reported. On 24Dec2020, the patient had something stuck in the throat; and had nausea. The patient had an emergency room visit due to the reported events; and had received a three-day course of oral prednisone and antihistamine, and then diphenhydramine (BENADRYL). The patient had no respiratory, cardiovascular, dermatological or gastrointestinal manifestations. The outcome of the events, 'something stuck in the throat' and 'nausea', was recovered on an unspecified date. The reporter had considered that there was a reasonable possibility that the events were related to the suspect vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/24/2020,2.0,PVT,,,Medical History/Concurrent Conditions: Shellfish allergy (used steroids),,,"['Nausea', 'Sensation of foreign body']",1,PFIZER\BIONTECH, 1051321,CT,40.0,F,"Pain at the site of injection; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL 3247), via an unspecified route of administration in left arm on 26Jan2021 12:45 PM at single dose for COVID-19 immunization. The patient's medical history included seasonal allergies. The patient had no allergies to medications, food, or other products. Concomitant medications included azelastine hydrochloride/fluticasone propionate (DYMISTA) and cetirizine hydrochloride. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 26Jan2021 16:00, the patient experienced pain at the site of injection. The event was considered as non-serious by the other healthcare professional. The patient did not receive any treatment for the adverse event. The outcome of the event was recovered on an unspecified date in 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,WRK,DYMISTA; CETIRIZINE HYDROCHLORIDE,,Medical History/Concurrent Conditions: Seasonal allergy,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1051322,IN,,M,"He mentioned experiencing side effects like soreness of arm,/pain in his arm; swollen and pain in his arm; Headache; Hearing impaired; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient just took the first dose of vaccine. On an unspecified date, he mentioned experiencing side effects like soreness of arm, swollen (also reported as not swollen, for clarification) and pain in his arm, headache and hearing impaired; nothing major. He also wanted to know if it is safe to take the multivitamins. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,,,UNK,,,,,,"['Headache', 'Hypoacusis', 'Pain in extremity', 'Peripheral swelling']",1,PFIZER\BIONTECH, 1051323,,,M,"His allergies are really bad; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. A male patient of an unspecified age received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced his allergies are really bad on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Drug hypersensitivity'],1,PFIZER\BIONTECH, 1051324,CO,,U,"fever; chills; This is a spontaneous report from a contactable healthcare professional via a sales representative. This healthcare professional reported same events for two patients. This is the first of two reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2 reported as Pfizer COVID-vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of received bnt162b2 (BNT162B2 reported as Pfizer COVID-vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The reporter mentioned that she had two X-Ray techs call in sick due to fever and chills with their second dose on an unspecified date. She said there have been a ton of people who have not gotten sick with their second dose. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021084275 same reporter/drug/events, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Chills', 'Pyrexia']",2,PFIZER\BIONTECH, 1051325,MI,,F,"felt across her chest a lot of pressure; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient felt across her chest a lot of pressure. Patient thought that it was just a heart burn but then confirmed that it's not. Patient wanted to know if this was a side effect because she is having second thoughts to take the second dose. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Chest discomfort'],1,PFIZER\BIONTECH, 1051326,WV,,F,"got diabetic ulcer infection on her foot before she got the vaccine, it got infected and irritated before she took the shot. However, it got irritated again after the first dose; got diabetic ulcer infection on her foot before she got the vaccine, it got infected and irritated before she took the shot. However, it got irritated again after the first dose; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. Medical history included diabetic ulcer infection on her foot before she got the vaccine, it got infected and irritated before she took the shot on an unspecified date. The patient's concomitant medications were not reported. The patient stated that she got a diabetic ulcer infection on her foot before she got the vaccine, it got infected and irritated before she took the shot. However, it got irritated again after the first dose on an unspecified date. The patient reported she was scheduled to get the second dose on 26Jan2021 (tomorrow) and she was getting ready to start antibiotic on 25Jan2021 (today). She asked if she can take her antibiotic because she will be getting her second dose. The outcome of the events was unknown. Information about the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Diabetic; Diabetic foot infection,,,"['Diabetic foot infection', 'Disease recurrence']",1,PFIZER\BIONTECH, 1051327,FL,,F,"upper lip swelling; cheeks turned to red; cheeks turned to red and burning; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that this female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced mild reactions such as upper lip swelling, cheeks turned to red, and burning that lasted for 2 hours. The outcomes of upper lip swelling and cheeks turned to red was unknown. The outcome of burning was recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Burning sensation', 'Erythema', 'Lip swelling']",UNK,PFIZER\BIONTECH, 1051328,WI,,F,"More localized pain at the injection site than is usual for a vaccine; This is a spontaneous report from a contactable physician (patient). This physician reported similar events for herself and one patient (her nurse). This is the first of two reports. A female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date at a single dose for Covid-19 immunization. Medical history included blood group O+. Concomitant medications were not reported. It was reported that the patient experienced more localized pain at the injection site than is usual for a vaccine. The outcome of the event was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021085284 same reporter, same drug, same event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: Blood group O (positive),,,['Vaccination site pain'],2,PFIZER\BIONTECH, 1051329,WI,,M,"Fever; Chills; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experience fever and chills on unspecified dates. The outcome of the events was recovered on unspecified dates. No follow-up attempts are possible: information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Chills', 'Pyrexia']",2,PFIZER\BIONTECH, 1051330,WI,,M,"rigors; This is a spontaneous report from a contactable physician. A male patient of an unspecified age started received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rigors on an unspecified date. Patients presented within 12-24 hours and persisted for 12-24 hours. The AE subsided after 48 hours. No follow-up attempts are possible. Information about batch/Lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,['Chills'],UNK,PFIZER\BIONTECH, 1051331,AZ,76.0,U,"heart palpitations/ my heart would race; hot flashes; flushing; shortness of breath; heavy feeling in my chest; my head would explode; rise in my blood pressure; several bathroom breaks; anxiety; heart beat a little faster; unforgiving fatigue; nightmares; injection site was minimally painful; This is a spontaneous report from a contactable consumer. A 76-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), via an unspecified route of administration at the age of 76 years, on 22Jan2021 13:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included asthma and obesity from an unknown date and unknown if ongoing. Concomitant medication included prednisone (PREDNISONE). The patient reported that the vaccination was given at approximately 1:30 pm on Friday 22Jan2021, and during the wait time after the shot was given, the patient had no problems, other than what the nurse said was probably anxiety when the patient's heart beat a little faster. The patient stopped at the grocery store, home for a bite to eat and then the unforgiving fatigue. The patient slept from 5:30 pm on Friday 22Jan2021 until 8:30 am on Saturday 23Jan2021 (with several bathroom breaks, but in bed, asleep). One of the problem during that time was nightmares of epic proportions. On Saturday 23Jan2021, the patient began to have semi-serious (enough that patient contemplated an ER visit) heart palpitations, flushing every couple of hours (similar to ""hot flashes"") and shortness of breath with a heavy feeling in chest, not gasping to breathe. Each and every time the patient got up to work, even across the room, patient's heart would race, as if the patient had been running, and would feel as though my head would explode (patient was assuming it was due to a rise in my blood pressure). These after-effects continued all day Saturday and all day Sunday. The patient did not have the fatigue issue and the injection site was minimally painful. On Monday, 25Jan2021, the heart situation was almost completely gone and I am having very small problems with breathing. The only time the patient seemed to have anything with breathing was when the patient does any extended activity (which is usually one of the normal causes of my asthma). Given the side effects, patient was concerned about my second shot as the patient have heard that shot seems to affect people much worse. The outcome of the events heart palpitations, shortness of breath and heavy feeling in my chest was recovering while other events were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/01/2021,,UNK,PREDNISONE,,"Medical History/Concurrent Conditions: Asthma (I have asthma, am currently taking 20 mg of prednisone daily.); Obesity",,,"['Anxiety', 'Blood pressure increased', 'Chest discomfort', 'Dyspnoea', 'Fatigue', 'Flushing', 'Head discomfort', 'Heart rate increased', 'Hot flush', 'Nightmare', 'Palpitations', 'Pollakiuria', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1051332,FL,79.0,M,"whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; having trouble bending his right elbow; This is a spontaneous report from two contactable consumers via the Pfizer-sponsored program. A 79-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249, expiration date 31May2021) on his left arm, intramuscular on 21Jan2021 10:30 at a single dose for covid-19 immunization. Medical history included ongoing congestive heart failure, ongoing type two diabetes, ongoing hypertension, transient ischemic attack, gout, depression and anxiety. Concomitant medication included allopurinol for Gout, ongoing spironolactone for Hypertension, buspirone hydrochloride anxiety and depression, ongoing finasteride, ongoing glipizide for type two diabetes, ongoing valsartan for Hypertension, ongoing apixaban for transient ischemic attack, ongoing doxazosin mesylate for Hypertension, ongoing loperamide, ongoing vitamin d3, ongoing pravastatin sodium, ongoing furosemide for Congestive heart failure and ongoing carvedilol for Hypertension. On Friday afternoon or evening, the patient was having trouble bending his right elbow. When he got up in the morning, his whole elbow 3 to 4 inches either way was swollen a lot and very painful. During the course of the day, it went down his arm and into his right hand. At its height it looked like a surgical glove that gets blown up for kids. It was very painful. Treatment: declines any Outcome: His elbow is still slightly swollen, not much pain at all He puts his glasses on to read the card. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/22/2021,1.0,UNK,ALLOPURINOL; SPIRONOLACTONE; BUSPIRONE HYDROCHLORIDE; FINASTERIDE; GLIPIZIDE; VALSARTAN; APIXABAN; DOXAZOSIN MESILATE; LOPERAMIDE; VITAMIN D3; PRAVASTATIN SODIUM; FUROSEMIDE; CARVEDILOL,Congestive heart failure; Hypertension; Type 2 diabetes mellitus,Medical History/Concurrent Conditions: Anxiety; Depression; Gout; Transient ischemic attack,,,"['Arthralgia', 'Joint range of motion decreased', 'Pain in extremity', 'Peripheral swelling']",1,PFIZER\BIONTECH,OT 1051333,CA,,M,"he developed a bump on his left elbow; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program Pfizer First Connect. A male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspeciied date, the patient developed a bump on his left elbow by where the shot was given. He stated that it was the size of a half golfball. Outcome of the event was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination site mass'],1,PFIZER\BIONTECH, 1051334,MA,,U,"experiencing vivid and detailed nightmares /dreams daily; This is a spontaneous report from a contactable physician (patient) via a Pfizer sales representative. A patient of unspecified age and gender received the second dose of bnt162b2 (BNT162B2 reported as COVID Vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history concomitant medications were not reported. The patient received the first dose of bnt162b2 (BNT162B2 reported as COVID Vaccine; unknown lot number and expiration date) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient reported that after the second Pfizer dose patient was experiencing vivid and detailed nightmares /dreams daily. These dreams have persisted for 3 weeks. The outcome of the event was not recovered. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Nightmare'],2,PFIZER\BIONTECH, 1051335,TX,41.0,F,"Itching that is spreading across my body; warm sensation at injection site; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration (at the age of 41-years-old) on 28Jan2021 15:00 at a single dose in left arm for COVID-19 immunization. Medical history included high blood pressure. The patient's concomitant medications were not reported. The patient previously took Keflex [cefalexin] and experienced allergy. The patient experienced itching that is spreading across my body and warm sensation at injection site on 28Jan2021 16:00 with outcome of not recovered. Treatment was not received for adverse event. The patient was not pregnant at the time of vaccination. The events were considered as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Pruritus', 'Vaccination site warmth']",1,PFIZER\BIONTECH, 1051336,,,F,"clear liquid started leaking down her arm; clear liquid started leaking down her arm; clear liquid started leaking down her arm; after the syringe was inserted, a clear liquid started leaking down her arm/wanted to know if she would have to repeat this process and get the 2nd dose again; This is a spontaneous report from a Pfizer Sponsored Program via a contactable consumer reporting for herself. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration (arm) on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown) on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that after the syringe was inserted, a clear liquid started leaking down her arm on an unspecified date. Patient wanted to know if she would have to repeat this process and get the 2nd dose again. Information on Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Accidental exposure to product', 'Accidental underdose', 'Exposure via skin contact', 'Product leakage']",2,PFIZER\BIONTECH, 1051337,AZ,80.0,F,"injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever 99-101 degrees; medical history of myasthenia gravis was given Pfizer-Biontech-Covid-19 Vaccine; medical history of myasthenia gravis was given Pfizer-Biontech-Covid-19 Vaccine; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH-COVID-19 VACCINE; lot number: EL1289; expiration date: unknown) was 80-year-old at the time of vaccination via an unspecified route of administration right arm on 26Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included myasthenia gravis, bipolar disorder, chronic obstructive pulmonary disease (COPD), hypothyroidism, high cholesterol and allergies to ACE inhibitors. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), fluticasone propionate (ALLER FLO), cetirizine hydrochloride (ALLER TEC), aspirin [acetylsalicylic acid] (ASPIRIN), clonazepam and ipratropium bromide (IPRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took ciprofloxacin (CIPRO) but had allergies. The patient received the most recent COVID-19 vaccine in a hospital. On 28Jan2021 07:00 AM, the patient had injection site pain, tiredness, headache, muscle pain, chills, joint pain and fever 99-101 degrees. The patient who has a medical history of myasthenia gravis was given Pfizer-Biontech-Covid-19 Vaccine on 26Jan2021 with unknown outcome. The patient did not received treatment from the adverse events and the events was considered as non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of all the other events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,PVT,TRELEGY; ALLER FLO; ALLER TEC; ASPIRIN; CLONAZEPAM; IPRA,,Medical History/Concurrent Conditions: Bipolar disorder; COPD; Drug allergy; High cholesterol; Hypothyroidism; Myasthenia gravis,,,"['Arthralgia', 'Body temperature', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Off label use', 'Product use issue', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1051338,,,F,"neck pain; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer Sponsored program. This female patient of unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported the patient was in neck pain; the patient stated it was not due to the COVID vaccine. She was supposed to take a steroid shot for her neck; the reporter inquired if she could get her second COVID vaccine with a steroid injection scheduled. The clinical outcome of neck pain was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on current available information, the event neck pain is more likely intercurrent and is assessed as unrelated to BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Neck pain'],1,PFIZER\BIONTECH, 1051339,,,F,"malaise; fever of 101.3; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 26Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose on an unknown date. The patient experienced malaise and fever of 101.3 (unknown unit) on 27Jan2021. The patient underwent lab tests which included body temperature: 101.3 on 27Jan2021. Outcome of the events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,UNK,,,,,,"['Body temperature', 'Malaise', 'Pyrexia']",2,PFIZER\BIONTECH, 1051340,NJ,,F,"wife's arm hurts a little bit 2-3 hours after the 1st dose of the vaccine / her arm is starting to hurt and is feeling a bit stiff; wife's arm hurts a little bit 2-3 hours after the 1st dose of the vaccine / her arm is starting to hurt and is feeling a bit stiff; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband asked if it's okay to take Tylenol because the patient's arm hurts a little bit 2-3 hours after the 1st dose of the vaccine and he's asking if he can drink wine. The husband mentioned that his wife also had an injection and around 4 or 5 hours ago mentioned that her arm was starting to hurt and was feeling a bit stiff. He told her that she could take Tylenol or Advil for it. The outcome of the events was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Musculoskeletal stiffness', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1051341,NC,69.0,F,"The itching was located just below the injection site at a spot where the skin was a little red; The itching was located just below the injection site at a spot where the skin was a little red; terrible itching in her left arm; out of balance, her balance was messed up; nervous; Sweaty; Feeling hot; felt like her heart was racing fast; felt dizzy/terrible lightheadedness; Feeling anxious; trouble sleeping; sharp pain in her muscle; This is a spontaneous report from a Pfizer-sponsored program. A contactable other health care professional reported that a 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot EL9263) via an unspecified route of administration at arm left on 24Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included drug allergies, IV contrast reaction. The concomitant medication was not reported. It was reported patient got the Pfizer COVID 19 vaccine Sunday 24Jan2021 at 13: 00PM in the left arm. She was scheduled for the second dose of the vaccine 16Feb2021. she got the vaccine and was perfectly fine; she started the wait time of 45 minutes and about 10 minutes into it she got really hot and felt like her heart was racing fast; felt dizzy on 24Jan2021. A nurse practitioner and a doctor came over and sat with her; she got some water and she was okay. They thought it was anxiety related to coming into a crowd, but for the next 36 hours she continued to feel anxious and on edge; she felt like she had too much caffeine. That night she had trouble sleeping; she had sharp pain in her muscles on 24Jan2021, it would be in one of her thighs then the other one. This was about 12 hours after the vaccine. States she took some tylenol and it did help. Adds she just continued to feel anxious and she was sweaty. States she has never has anything like this before. Today she felt perfectly fine; all of her symptoms had resolved. Then today, when she was driving to a routine GYN exam and she experienced a terrible itching on her left arm on 24Jan2021. It was sudden and startled her. The itching was located just below the injection site at a spot where the skin was a little red, feathery red, just below the injection site. Now the itching has stopped but it is still red. she couldn't hardly feel it being injected, she doesn't usually have reactions to vaccines, she never had anything, but she has a few drug allergies, and she was separated out, she was flagged to wait 45 minutes after, instead of the 15. She does have an IV contrast reaction, and some other things, nothing she knew was in the vaccine, she was fine and wasn't worried that she was aware of. She thinks she got too hot, she had on a coat, she was sitting and panning through stuff, reading on her phone, and all of a sudden she had terrible lightheadedness, she never fainted in her life, she is pretty sturdy, she didn't know what to think, she was lightheaded, and it was not vertigo, not like the room was flying, but she was like out of balance, her balance was messed up, and she sat there a minute, she was too hot, she got out of her coat, and it got worse, she could feel her heart racing, and she was talking to herself, she thinks she nervous, she could feel her heart pounding, and was instructed to raise her hand if she had issues, so she raised her hand, a nurse practitioner came over, she raised her hand, and the doctor making rounds came over and he said take off your mask off, she did, that helped somewhat, it was that blasted mask, she couldn't get enough air, he gave her water, she thinks she got too hot and perhaps got nervous and didn't think she was she said she's not been around people, and was suddenly in a huge crowd, everyone was appropriately distanced, it was an extreme presentation, after 5-6 minutes, she was good, it went away, but for 36 hours she didn't feel right, she could feel sometimes her balance wasn't right, she was just not herself, she could do her usual, she lives on a farm, she did usual farm stuff, but was not herself, and in the night, she woke several times, her heart was beating too fast, too much, but she went back to sleep, and she told her son, she said it felt like she had had 4-5 cups of really strong coffee. So the next day she was ok. Absolutely her normal, and then she didn't think anything about it, and was driving to a routine GYN exam, which was canceled last moment due to an emergency, she was driving and suddenly her arm started itching, this was Tuesday, so 48 hours after, not the site, it was distal, underneath it, maybe 2-3 inches under injection site. The site did nothing, she looked that night, no redness, lump, no raised area, no warmth, nothing, but then she had itching, intense itching like poison ivy, and she scratched and thought wait a minute, at her appointment she looked at her arm, this area was 3-4inches under the site, that was red, feathery looking and flat, macular, not raised, no induration, no warmth, no lump, no pain, it was feathery dusty red and the next day it was gone, she did nothing to it, she thought to put hydrocortisone, and looked at it, but it was so faint and wasn't itching. The seriousness was reported as non-serious. The outcome of the events was Feeling hot was recovered on 24Jan2021; Heart rate increased; felt dizzy; Muscle pain; Sweaty was recovered on 25Jan2021; Feeling anxious was recovered on 26Jan2021; Vaccination site rash; Vaccination site erythema recovered in 2021. Vaccination site pruritus was recovering; Difficulty sleeping; Loss of balance, Nervous was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/24/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Contrast media reaction; Drug allergy,,,"['Anxiety', 'Balance disorder', 'Dizziness', 'Feeling hot', 'Heart rate', 'Heart rate increased', 'Hyperhidrosis', 'Insomnia', 'Myalgia', 'Nervousness', 'Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site rash']",1,PFIZER\BIONTECH, 1051342,UT,,F,"BNT162B2 on 25Jan2021; Right armpit, got swollen and hard; Right armpit, got swollen and hard; This is a spontaneous report from a contactable healthcare professional (patient) via a Pfizer-sponsored program, Pfizer First Connect. This female patient of unspecified age received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 on 08Jan2021 for COVID-19 immunization. The patient reported after getting the second dose yesterday (as of 26Jan2021), her right armpit got swollen and hard. The clinical outcomes of her right armpit got swollen and hard, and BNT162B2 on 25Jan2021 were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/01/2020,,UNK,,,,,,"['Induration', 'Oedema peripheral', 'Product use issue']",2,PFIZER\BIONTECH, 1051343,SC,,U,"runny nose; chill; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced a runny nose, had a chill and had 97.8 degree Fahrenheit body temperature. Outcome of the events was unknown. Information on Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/01/2021,,UNK,,,,,,"['Body temperature', 'Chills', 'Rhinorrhoea']",UNK,PFIZER\BIONTECH, 1051344,,,F,"anxiety attack; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program Pfizer First Connect. This female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history included dental work done from an unknown date and unknown if ongoing. Concomitant mediations were not reported. The patient reported that she had the COVID vaccine and dental work done, inquired if that was okay; while asking, the patient mentioned she didn't want to answer questions due to having an anxiety attack. The clinical outcome of anxiety attack was unknown. No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Dental treatment (dental work done),,,['Anxiety'],UNK,PFIZER\BIONTECH, 1051345,FL,78.0,F,"UTI; This is a spontaneous report from a contactable consumer (patient). This 78-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EJ1284; expiration date 30Apr2021) via an unspecified route of administration on 12Jan2021 (at the age of 78-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that two weeks ago (as of 26Jan2021) she got her first COVID-19 vaccine shot, and a week from today (as of 26Jan2021), 02Feb2021, she is scheduled for her second COVID-19 vaccine shot. She stated had been prescribed an antibiotic for a urinary tract infection (UTI) and she was to take the antibiotic for 7 days. She clarified that the last day she will take the antibiotic was Tuesday, 02Feb2021. She wanted to know if she had to worry about an interaction between the second COVID-19 vaccine dose and the antibiotic she was prescribed. She clarified further that she was prescribed the generic BACTRIM, ""sulfamethoxazole-TMP-DS."" The patient also reported that her urinary tract infection had nothing to do with receiving the first dose of the COVID-19 vaccine; she stated she got UTIs all the time. The clinical outcome of UTI was unknown. No follow-up needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Urinary tract infection is most likely related to an intercurrent or underlying condition which is not related to the suspected drug BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/01/2021,,UNK,,,,,,['Urinary tract infection'],1,PFIZER\BIONTECH, 1051346,FL,70.0,F,"About 20 min after vaccine i felt a slight thickening of back of tongue.came and went within seconds. i am conerned about second dose; This is a spontaneous report from a contactable Consumer (patient). A 70-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 17Jan2021 13:30 at single dose for COVID-19 immunization in hospital. Medical history included atrial fibrillation. Concomitant medications in two weeks included apixaban (ELIQUIS), metoprolol succinate (TOPROL XL), levothyroxine sodium (SYNTHROID), semaglutide (OZEMPIC). There was no other vaccine in four weeks. The patient previously had known allergies to epinephrine. About 20 min after vaccine she felt a slight thickening of back of tongue. It came and went within seconds. She was concerned about second dose. The event onset time was also reported as 18Jan2021 13:00. The event did not result in emergency room visit or physician office visit. There was no treatment for the event. There was no covid prior vaccination or covid tested post vaccination. The event was resolved on 18Jan2021. Information on batch/lot has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/17/2021,01/18/2021,1.0,PVT,ELIQUIS; TOPROL XL; SYNTHROID; OZEMPIC,,Medical History/Concurrent Conditions: AFib (other medical history: Afib),,,['Tongue disorder'],1,PFIZER\BIONTECH, 1051347,NV,70.0,F,"flushing of face within 10 minutes, light rash arms, and trunk; flushing of face within 10 minutes, light rash arms, and trunk; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 23Jan2021 01:00 PM at a single dose on the right arm for COVID-19 immunization. The patient did not receive any other vaccine within four weeks prior to receiving bnt162b2. The patient was not diagnosed with covid prior to vaccination. The patient was not pregnant. Medical history included allergies to tree nuts, bees, penicillin, and sulfa. Concomitant medications were included hormones, fluticasone propionate, salmeterol xinafoate (ADVAIR), and esomeprazole sodium (NEXIUM). The patient experienced flushing of face within 10 minutes (as reported), light rash arms, and trunk on 23Jan2021 01:15 PM (as reported). The patient was not tested for covid post-vaccination. The patient received Benadryl as a corrective treatment. Outcome of the events was recovered on an unspecified date in Jan2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/23/2021,0.0,UNK,ADVAIR; NEXIUM [ESOMEPRAZOLE SODIUM],,Medical History/Concurrent Conditions: Bee sting hypersensitivity; Fruit allergy; Penicillin allergy; Sulfonamide allergy,,,"['Flushing', 'Rash']",1,PFIZER\BIONTECH, 1051348,IL,35.0,F,"maybe a little low iron but not too remarkable; swelling in middle finger of right hand/puffiness in all of fingers and toes and around eyes; puffiness in all of fingers and toes and around eyes; she was not feeling great; fatigue; headache; soreness in her arm at the injection site; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) on her right arm, via an unspecified route of administration on 20Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on 23Dec2020, she was not feeling great, had fatigue and headache. On 25Dec2020, she had swelling in her right middle finger, states that has now progressed to swelling in all her fingers, toes and around her eyes. Also reported that on 21Dec2020, she had soreness in her arm at the injection site that went away the same day. The patient also mentioned that she tested negative for Covid. The patient is also a little low iron but not too remarkable. The outcome of the event vaccination site pain was recovered in 21Dec2020, not recovered for peripheral swelling and puffy eyes while unknown for the other events. Information on Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/21/2020,1.0,UNK,,,,,,"['Blood iron', 'Blood iron decreased', 'Fatigue', 'Headache', 'Malaise', 'Periorbital swelling', 'Peripheral swelling', 'SARS-CoV-2 test', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1051349,CA,56.0,F,"severe soreness at the injection site; soreness at the injection site was so severe that she was unable to sleep or lift her arm; soreness at the injection site was so severe that she was unable to sleep or lift her arm; Chills; mild headache; Nausea; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EC324U), via an unspecified route of administration on 11Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included penicillin allergy. Concomitant medications included unspecified daily vitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via intramuscular on an unspecified date at 12:00 pm at 56- years of age on the left arm for COVID-19 immunization and had only mild muscle soreness at injection site. The patient was not diagnosed with COVID-19 prior to vaccination. On 11Jan2021, at eight hours post injection, the patient experienced severe soreness at the injection site. The patient stated that the soreness at the injection site was so severe that she was unable to sleep or lift her arm. On the same day, the patient also had chills, mild headache and nausea. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event mild headache was not recovered while the other events was recovered on an unspecified date in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Chills', 'Headache', 'Insomnia', 'Nausea', 'Vaccination site movement impairment', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1051350,NC,73.0,F,"we noticed our arms wore sore/right arm soreness following injection; This is a spontaneous report from a contactable consumer (patient's husband) reporting for a patient. A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3247, Expire Date: 31May2021), intramuscular (right arm) on 24Jan2021 13:30 at SINGLE DOSE (first dose) for covid-19 immunisation. Medical history included reported as none. The patient did not COVID virus prior vaccination. Patient did not have prior vaccinations within 4 weeks. There were no concomitant medications. The patient experienced arms were sore/right arm soreness following injection on 24Jan2021 before bed. It has improved, it was way better and that she was good. No treatment was given and no lab tests were done. Outcome of the event was recovering. The event did not require emergency room visit or physician office visit.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/24/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Vaccination site pain'],1,PFIZER\BIONTECH,OT 1051351,IL,62.0,F,"tested positive for strep throat; shocked she has strep throat; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:ELO142), via an unspecified route of administration on the left arm at the age of 62 years on 12Jan2021 10:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and asthma from an unknown date and unknown if ongoing. Concomitant medication included budesonide, formoterol fumarate (SYMBICORT) and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) both for asthma. The patient had the first part of the Pfizer vaccine. Overall, she had no side effects, but in between getting the vaccine her asthma was bothering her. She went to an Urgent Care and was getting her asthma medicines changed and got tested for Covid and for Flu and both were negative. She was also tested for strep throat and that was positive. She didn't really have any symptoms of a sore throat or anything, she maybe felt some sinus drainage prior to it, but no symptoms. She was shocked she has strep throat and they gave her medication for it and she was almost done with that and wanted to make sure she is able to get the second part. It was clarified her asthma was bothering her prior to getting the vaccine and she was in the midst of getting her asthma medications changed because her asthma wasn't controlled and she was having something with the medications. She had the Covid, flu, and strep testing at her visit on 20Jan2021. She was being seen at the Urgent Care because of her asthma already, not about the vaccine and was given something for the strep. No other vaccines given that day or 4 weeks prior. No problems with vaccines in past. Asthma medication, Symbicort was changed because she felt like she was having side effects. Not sure when she stopped it, but started taking it she started taking it again right before she had testing and got the vaccine. May have stopped taking it about end of November, but tried it again around testing time. She mentioned taking regular medications and medication for high blood pressure and asthma medication. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Jan2021 and streptococcus test: positive on 20Jan2021. The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/20/2021,8.0,PVT,SYMBICORT; BREO ELLIPTA,,Medical History/Concurrent Conditions: Asthma; Hypertension,,,"['Pharyngitis streptococcal', 'SARS-CoV-2 test', 'Streptococcus test']",UNK,PFIZER\BIONTECH, 1051352,NC,71.0,F,"Dry cough; Sore throat; Diarrhea; Nausea; muscle aches; joint aches; extreme fatigue; Headache; have been sick ever since; flu like symptoms; hoarse; This is a spontaneous report received from a contactable consumer (patient). This consumer reported similar events for herself and her husband. This is the first of 2 reports. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 20Jan2021 at 10:15-10:30 (as reported), at single dose, for COVID-19 immunization, at the hospital. There were no medical history, family history and concomitant medications. The patient had no vaccinations within four weeks prior to the first administration of BNT162B2 vaccine. The patient reported that she and her husband had the Pfizer Covid 19 shot on 20Jan2021 (last Wednesday). She stated that they have been sick ever since. On 20Jan2021, the patient had flu-like symptoms and at 11:00, she experienced headache. On 21Jan2021, the patient experienced nausea, muscle aches, joint aches and extreme fatigue. On 22Jan2021, the patient had sore throat during the night and diarrhea. On 23Jan2021, the patient had dry cough. On an unspecified date in Jan2021, the patient was hoarse. The events did not require emergency room visit of physician office visit. The patient wanted to know if they should get the second shot. The outcome of the events ""have been sick ever since"", ""flu like symptoms"", headache, nausea, extreme fatigue and ""hoarse"" was not recovered; the patient was recovering from muscle aches and joint aches; the patient recovered with sequel from dry cough on 23Jan2021 and sore throat on 24Jan2021; the patient recovered from diarrhea on 24Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093716 Same reporter, suspect drug and events; different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/01/2021,,PVT,,,,,,"['Arthralgia', 'Cough', 'Diarrhoea', 'Dysphonia', 'Fatigue', 'Headache', 'Illness', 'Influenza like illness', 'Myalgia', 'Nausea', 'Oropharyngeal pain']",1,PFIZER\BIONTECH, 1051353,OH,94.0,F,"elbow starting hurting more, and it was on the same arm as the side she got the injection on, the right arm; is real tired and she even slept 14 hours last night; is real tired and she even slept 14 hours last night; This is a spontaneous report from a contactable Consumer (patient's husband). A 94-year-old female patient received the first dose bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249), via an unspecified route of administration (right arm) on 21Jan2021 at SINGLE DOSE (arm right) for covid-19 immunisation. Medical history included left shoulder pain (on medication for years) from an unspecified date, and elbow that she fell on two weeks before on Jan2021. Concomitant medication included hydrocodone for left shoulder pain. On 24Jan2021, the patient experienced real tired and she even slept 14 hours the night before. Reporter was wondering if tiredness is a side effect of the product. The patient also had an elbow that she fell on two weeks before on Jan2021, and three days after getting the vaccine (24Jan2021), that elbow started hurting more, and it was on the same arm as the side she got the injection on, the right arm. The reporter was unsure of the lot number reported as E13249 or EL3249 (unsure which lot number is his, and which is the one his wife received). The patient received no other vaccines on the same day as the COVID vaccine. Outcome of the event ""elbow starting hurting more, and it was on the same arm as the side she got the injection on, the right arm"" was not recovered. Outcome of events ""is real tired and she even slept 14 hours last night"" was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/24/2021,3.0,UNK,HYDROCODONE,,Medical History/Concurrent Conditions: Fall; Shoulder pain,,,"['Arthralgia', 'Fatigue', 'Sleep disorder']",UNK,PFIZER\BIONTECH, 1051354,CT,75.0,M,"Diagnosed as Angioedema; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number EL9265) via an unspecified route of administration on 28Jan2021 10:00 into left arm at a single dose for COVID-19 immunisation. The patient medical history included Hypersensitivity Pneumonitis (PF-ILD) Interstitial Lung Disease and the patient allergies to Lisinopril, meclizine, and Bactrim. There is no other vaccine was administered in four weeks. There is no COVID prior to vaccination. Concomitant medications within two weeks included nintedanib, atorvasatin, Vitamin D3, cyanocobalamin (VITAMIN B12) and acetylsalicylic acid (ASPRIN). The patient diagnosed as angioedema on 30Jan2021 and result in emergent room/department or urgent care. The patient awoke on 31Jan2021 with facial swelling, lip swollen right side of face. No swelling of throat. The patient received methylprednisolone (Solu-MEDROL) injection 125mg, tranexamic acid (CYKLOKAPRON) 1 g in sodium chloride 0.9% 100 ml IVPB (mini-bag plus) as treatment. The patient did not test COVID post vaccination. The outcome of the event was recovering. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/30/2021,2.0,PUB,NINTEDANIB; ATORVASTATIN; VITAMIN D3; VITAMIN B12; ASPRIN,,Medical History/Concurrent Conditions: Hypersensitivity pneumonitis; Interstitial lung disease,,,['Angioedema'],1,PFIZER\BIONTECH, 1051355,CA,51.0,M,"Universal hair loss: scalp, eyelashes, eye brows, pubic hair; Universal hair loss: scalp, eyelashes, eye brows, pubic hair; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686A) at the age of 51 years-old via unspecified route of administration on 08Jan2021 in left arm at single dose for COVID-19 immunization in the hospital. Medical history included GERD (Gastroesophageal reflux disease). The patient had no allergies to medications, food, or other products. Concomitant medication included VITAMIN D NOS. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) at the age of 51 years-old via unspecified route of administration on 20Dec2020 at 01:00 PM in left arm for COVID-19 immunization. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 15Jan2021 patient experienced universal hair loss: scalp, eyelashes, eyebrows, pubic hair. No treatment received for the adverse events. Since the vaccination, the patient has been tested for COVID-19. Post vaccination patient underwent labs and procedure on 19Jan2021 included PCR (Polymerase chain reaction): negative, Nasal swab: negative. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/15/2021,7.0,PVT,VITAMIN D NOS,,Medical History/Concurrent Conditions: GERD,,,"['Alopecia', 'Madarosis', 'Polymerase chain reaction', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1051356,FL,32.0,F,"My left hand turned blue and the veins in that hand looked very dark (almost purple); soreness across entire arm, especially at injection site; swollen injection site; tingling across entire arm; soreness across entire arm; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 27Jan2021 16:00 (lot number: EN5318), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in public health department. The patient's medical history includes sciatic nerve pain, allergic to cats and some dogs, back pain from scoliosis and anemic, all from an unknown date and unknown if ongoing. The patient had no concomitant medications. The patient did not receive any other vaccine within four weeks. The patient did not receive any other medications the patient received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. The patient stated her left hand turned blue and the veins in that hand looked very dark (almost purple) seconds after receiving the vaccine in the left arm on 27Jan2021 16:00. Her left hand turned blue like it was cold, but she was not cold anywhere on my body. Her left hand's veins were also mostly purple in the fingertips. The side effect was not painful and lasted about 30 minutes. Other symptoms experienced because of the COVID-19 vaccine in left arm were soreness across entire arm, especially at injection site occurred upon injection and was slowly getting better. The patient took two 200mg of ibuprofen two days (however the patient also reported no treatment was received for the events) after the injection because the pain randomly got worse without any outward cause, swollen injection site occurred upon injection and is the same at this time. Tingling across entire arm occurred upon injection and stopped seven hours later at 11pm. The consumer assessed the events as non-serious. The outcome of the event tingling across entire arm recovered on 27Jan2021 at 11 PM and ""my left hand turned blue and the veins in that hand looked very dark (almost purple)"" was recovered on 27Jan2021 and outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,PUB,,,Medical History/Concurrent Conditions: Allergy to animals (Allergic to cats and some dogs); Anemic; Back pain (back pain from scoliosis); Nerve pain (Sciatic nerve pain); Scoliosis (back pain from scoliosis),,,"['Pain in extremity', 'Paraesthesia', 'Vaccination site pain', 'Vaccination site swelling', 'Vein discolouration']",1,PFIZER\BIONTECH, 1051357,NY,50.0,F,"back pain; bilateral leg pain; This is a spontaneous report from a contactable other health professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 123302), via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ergocalciferol (VIT D) and an unspecified vaccine (lot number: P 100242861) taken for an unspecified indication on 01Dec2020. The patient previously took the first dose of BNT162B2 (lot number: EL0140), at 50-years of age via intramuscular route, on 30Dec2020 at 03:30 pm on the left arm for COVID-19 immunization and four days after the injection, patient had severe low back pain, difficulty walking, standing, sitting. The patient was not diagnosed with COVID-19 prior to vaccination. On an unspecified date, the patient experienced back pain along with bilateral leg pain. The patient did not receive any treatment for the reported events. The patient underwent lab test which included nasal swab test which showed negative result on 21Jan2021. The outcome of the events was recovering. The patient was not pregnant at the time of vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,,,SEN,VIT D,,,,,"['Back pain', 'Pain in extremity', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1051358,AZ,,F,"pain to that area when lifting arm; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date unknown), via an unspecified route of administration, in Jan2021 (reported as ""3 weeks ago""), at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had complaints of pain to that area when lifting arm (pending clarification) in Jan2021. The patient was scheduled to have the second dose in the afternoon of 27Jan2021. The outcome of the event was unknown. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1051359,,75.0,F,"flu like symptoms; diarrhea; severe/bad headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number: EL9261; expiry date: unknown) at the age of 75 years old, via an unspecified route of administration in the right arm, on 23Jan2021 09:00, at a single dose, for COVID -19 immunization. The patient had no relevant medical history and was not taking concomitant medications. Patient reported that she got the Pfizer Covid vaccine shot on 23Jan2021 at 9:00. On 24Jan2021, about 2:00, the next morning, she felt like she got hit by a bus further described as flu like symptoms including nausea, diarrhea, and a severe/ bad headache. The events were treated with Phenergan at home. These symptoms lasted about a day; patient completely recovered on 25Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/24/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Diarrhoea', 'Headache', 'Influenza like illness', 'Nausea']",1,PFIZER\BIONTECH, 1051360,MN,72.0,M,"Headache; left arm and back pain; left arm and back pain; everything hurt; This is a spontaneous report from a contactable consumer (patient). This 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK4176; dose 1) via an unspecified route of administration on 23Jan2021 at 16:00 (at the age of 72-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included a dental appointment in Jan2021; the patient had no other conditions. Concomitant medications were not reported. The patient previously took penicillin and had a reaction when he was younger. The patient had not had adverse events from prior vaccinations. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 24Jan2021 the patient experienced headache, left arm and back pain, everything hurt. The patient said that ""it"" didn't bother him at all that day (23Jan2021) but on 24Jan2021 he had headaches, left arm and back pain and everything hurt. It was worse ""yesterday"" but ""today"" (on an unknown date) his arm and back still hurt. The events did not require a visit to the emergency room or physicians office. The patient underwent lab tests and procedures which included a new dental crown put on on 25Jan2021. The clinical outcome of headache was recovering. The outcome of left arm and back pain and everything hurt was not recovered. No follow-up attempts are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/24/2021,1.0,MIL,,,Medical History/Concurrent Conditions: Penicillin allergy (States in past he had a reaction to Penicillin when he was younger.),,,"['Back pain', 'Headache', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 1051361,WA,45.0,F,"hot flash sensation on right side body under her arms down side of her body; This is a spontaneous report from a contactable pharmacist (patient). This 45-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3302; dose 1) via an unspecified route of administration on 26Jan2021 (at the age of 45-years-old) as a single dose in the arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced hot flash sensation on the right side of her body. The patient stated she got the vaccine ""today"" (26Jan2021) and wanted to find out if the kind of side effect she was having would resolve or if she needed to contact her physician. She had been experiencing a hot flash sensation on the right side of her body under her arms and down the side of her body on 26Jan2021. The outcome of hot flash sensation on the right side of her body was not recovered. No follow-up attempts are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,UNK,,,,,,['Hot flush'],1,PFIZER\BIONTECH, 1051362,NY,69.0,F,"Chills; Fever of 100.2; Headache; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 13:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 26Mar2020, she tested positive for Covid. In the beginning of May2020, she went to get tested for antibodies, she did have them, that she received a report, number was 8.2 and knows that at 1.4 she would be considered to have antibodies so they told her it was good that her number was high, she asked them what it meant and they told her they did not know. Patient had chills, fever of 100.2, bad headache, and muscle aches on 20Jan2021. She took Tylenol to treat her symptoms and they went away, and states they would come back as Tylenol wore off. Her symptoms have completely resolved however she does not have the exact date. Outcome of the events was recovered on Jan2021. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/20/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Antibody test', 'Body temperature', 'Chills', 'Headache', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1051363,,71.0,F,"10 days later arm got red; soreness to her arm; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 16Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has a question about the COVID-19 vaccine. She stated that she thought she had a simple question, and she called the COVID hotline, and the CDC and they just keep bouncing her around. She said she had her first dose of the vaccine on 16Jan2021, and wasn't bothered by it, she had just a bit of soreness when she touched her arm (unspecified date in Jan2021), but 10 days later, on 26Jan2021, her arm got red, so she is wondering if this could be a delayed reaction. She stated that she is not having bad effects, she is just wondering why it would pop up after so many days. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,01/01/2021,,UNK,,,,,,"['Erythema', 'Pain in extremity']",1,PFIZER\BIONTECH, 1051364,MN,72.0,M,"Lip swelling; Extreme tiredness; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231) via an unspecified route of administration on the left upper arm on 25Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history seafood allergy. There were no family medical history and concomitant medications. The patient previously received flu shots in Sep2020 (Has had 100's of vaccines while in the army and never had a reaction to any of them). The patient experienced extreme tiredness on 25Jan2021; was noticed at 6pm when he fell asleep on the phone. Right now, he is fine, stating later he was just a little tired. Lip swelling- this was noticed about 11pm on 25Jan2021 the day he received the shot, when he woke to go to the bathroom. Both lips were swollen but he wasn't worried as he knew this was a possible side effect. He reported that he was back to normal other than being a little tired. He just slept. Patient reported that he couldn't stay awake for a more than 5 minutes but he is still very glad he got it. The second dose is due 15Feb2021. The events did not require a visit to physician office or emergency room. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No relevant tests done. Outcome of the event lip swelling was recovered on 26Jan2021 while the event extreme tiredness was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Seafood allergy,,,"['Fatigue', 'Lip swelling']",1,PFIZER\BIONTECH, 1051365,MO,,F,"Nausea; Fever; Diarrhea; Pain and stiffness in her chest; Pain and stiffness in her chest; can't seem to regulate her body temperature; Laboring to breathe; Immediate soreness in arm; couldn't really taste, things didn't really taste right; Muscle pain; Joint pain; Red rash; Hives; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. This consumer reported for a patient (other health professional). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. It was reported that the patient was having the same symptoms with the caller except that it was after receiving the second dose. On an unspecified date, the patient experienced immediate soreness in arm, stated that she couldn't really taste, things didn't really taste right, muscle pain, joint pain, red rash, hives, nausea, fever, diarrhea, and pain and stiffness in her chest. She also can't seem to regulate her body temperature and was laboring to breathe on an unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076108 same reporter/drug, similar events, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Arthralgia', 'Body temperature', 'Body temperature abnormal', 'Chest pain', 'Diarrhoea', 'Dyspnoea', 'Musculoskeletal stiffness', 'Myalgia', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Rash erythematous', 'Taste disorder', 'Urticaria']",2,PFIZER\BIONTECH, 1051366,SC,78.0,F,"Nausea/sick to her stomach; Headache; stomach is upset; not feeling great; dizziness; Vertigo; This is a spontaneous report from a contactable consumer. A 78-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) on her left arm, via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. It was reported that the patient got shot on Friday and last night she woke up with vertigo on 25Jan2021. This morning (26Jan2021), she could not eat breakfast because she was nauseous and sick to her stomach; stomach is upset. She is walking around now and just is not feeling great. She also has a headache and dizziness. The outcome of the event nausea was recovering while unknown for the other events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/25/2021,3.0,UNK,,,,,,"['Abdominal discomfort', 'Dizziness', 'Headache', 'Malaise', 'Nausea', 'Vertigo']",UNK,PFIZER\BIONTECH, 1051367,FL,71.0,F,"tested positive for the COVID-19 Virus after the first vaccine dose; Terrible headache; Nauseous; Very tired and weak; Very tired and weak; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EI8982 or EL8982), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. Medical history included thyroid disorder. Concomitant medication included calcium and levothyroxine sodium (SYNTHROID) for her thyroid. The patient reported that she had her first COVID-19 vaccine dose on 20Jan2021 and her doctor told her not to get the second COVID-19 vaccine dose scheduled for 10Feb2021 because she felt so bad after receiving the first COVID-19 vaccine dose. Five hours after receiving the first dose, she ended up getting terrible headache and was also nauseous and got very tired and weak. She then had both a COVID-19 virus antigen test and a COVID-19 virus PCR test performed on Monday, 25Jan2021 and the COVID-19 virus antigen test came back positive later in the day on 25Jan2021 and the COVID-19 virus PCR test came back positive on 27Jan2021. No treatment was received for the events. Outcome of the events was unknown. Information about lot and batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/20/2021,0.0,UNK,CALCIUM; SYNTHROID,,Medical History/Concurrent Conditions: Thyroid disorder,,,"['Asthenia', 'Fatigue', 'Headache', 'Nausea', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1051368,MA,59.0,F,"small sore throat; little bit of congestion; lot of aches and pains; very tired; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EL1284, expiry date: 31Apr2021), via an unspecified route of administration on the left arm, on 15Jan2021 09:30, at single dose, for covid-19 immunization. Medical history included heart issues from an unspecified date, cardiac ablation in 2020, total knee replacements on 2001 (approximately 20 years ago) and 2009 (approximately 12 years ago), spinal fusion surgery in 2017 (3 fused disc in her back approximately 4 years ago). Concomitant medication included cortisone which started on 21Jan2021 (as reported, pending clarification) for an unspecified indication. In Jan2021 (reported as ""Saturday morning""), the patient experienced small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired. She was calling because she didn't know if it was possible if she could be having a reaction. She stated she had one other symptom, her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too. Treatment for the events small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired included Mucinex Night Shift Cold and Flu syrup, Halls Relief lozenges and Advil. The patient reported that her symptoms have stayed about the same. The patient took her temperature on an unspecified date and reported that it was fine. She reported she did not any lab tests done for the events. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/01/2021,,UNK,CORTISONE,,Medical History/Concurrent Conditions: Cardiac ablation; Cardiac disorder NOS; Spinal fusion (approximately 4 years ago); Total knee replacement (approximately 20 years ago); Total knee replacement (approximately 12 years ago),,,"['Body temperature', 'Erythema', 'Fatigue', 'Flushing', 'Nasal congestion', 'Oropharyngeal pain', 'Pain']",1,PFIZER\BIONTECH, 1051369,TX,,F,"she forgets her own address; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 18Jan2021 17:00, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she was fine and wanted to inform that she had her Covid vaccine shot on 18Jan2021 at 17:00. She has not been sick and does not have fever. She was now waiting on the date for the second dose. She then mentioned that she forgets her own address on Jan2021. The outcome of the event was unknown. Information about the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,01/01/2021,,UNK,,,,,,['Memory impairment'],1,PFIZER\BIONTECH, 1051370,FL,57.0,F,"Sore arm; Pain in chest to her left upper sternal border area (under collar bone); Pain in the neck, its an aching pain, a nuisance type of pain; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the left deltoid on 28Dec2020 (07:15) at a single dose for COVID-19 immunization at the hospital. The had no relevant medical history and concomitant medications. On an unspecified date, after the first dose of vaccination, the patient had sore arm; pain in chest to her upper sternal border area (under the collar bone); and pain in the neck (further described as ""an aching pain, a nuisance type of pain""). The patient had chest x-ray on 25Jan2021 (results were not provided). The patient had received paracetamol (TYLENOL), naproxen sodium (ALEVE) and ibuprofen as treatment for the reported events. The outcome of the events was not recovered for 'pain in chest to her upper sternal border area (under the collar bone)'; and was unknown for 'sore arm' and 'pain in the neck'. The patient had received the second dose of vaccination on 14Jan2021. The reporter believed that it was ""highly coincidental"" (pertaining to causality) considering the events happened with both vaccine doses. No further information was provided or obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chest X-ray', 'Chest pain', 'Neck pain', 'Pain in extremity']",1,PFIZER\BIONTECH,OT 1051371,,,F,"Temperature of 103; Had severe body aches; Weakness; This is a spontaneous report from a non-contactable consumer reporting for a patient. A female patient in her 60's received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on an unspecified date at SINGLE DOSE for preventative for Covid 19. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown) on an unspecified date for covid-19 immunisation. The patient experienced temperature of 103, had severe body aches, and weakness on an unspecified date which lasted for two days and then recovered on an unspecified date. No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Asthenia', 'Body temperature', 'Body temperature increased', 'Pain']",2,PFIZER\BIONTECH, 1051372,NC,64.0,F,"after getting the vaccine, her taste and smell came back which has been gone since Oct2017 when she had shingles in her mouth and right side of face; This is a spontaneous report received from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 lot number: EK9231, expiry date: 30Apr2021), via an unspecified route of administration on the left arm, on 24Jan2021 15:30, at 0.3 mL, single, to protect her husband and her neighbor/COVID-19 immunization. Medical history included shingles in her mouth and right side of her face in Oct2017; and has not been able to taste or smell since 2017. There were no concomitant medications. The patient had shingles in her mouth and right side of her face on Oct2017 and she lost her taste and smell from it. She has not been able to taste or smell since 2017. The patient called to report a positive thing that happened after she got the COVID-19 vaccine on 24Jan2021 15:30. By the morning of 25Jan2021, the patient fixed her coffee and when she drank her coffee, she tasted it. She was like, 'wait a minute'. So, she took another sip. She can taste and smell. She smelled and tasted everything. After the coffee, she fixed an egg and put extra salt and pepper and she could taste it. After getting the vaccine, her taste and smell came back which has been gone since Oct2017 when she had shingles in her mouth and right side of face. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/24/2021,01/25/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Loss of smell; Loss of taste; Shingles,,,['Therapeutic response unexpected'],1,PFIZER\BIONTECH, 1051373,SD,75.0,M,"hives from his knee to his chest, and from his chest to his arm and to his neck area, hives had little red bumps and were itchy; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261), via an unspecified route of administration on the left arm, at the age of 75 years, on 21Jan2021 10:00 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient said he had red hives develop on Saturday, 23Jan2021. He went to an Urgent Care for treatment. He said the doctor at the Urgent Care looked at his hives, and told him the hives were likely related to the COVID-19 Vaccine, but the doctor was not positive of that. The patient said he hadn't had any recent changes in his health, or issues before he received the COVID-19 Vaccine, so that was why the doctor thought the hives were from the COVID-19 Vaccine. He clarified he has hives from his knee to his chest, and from his chest to his arm and to his neck area. He clarified the hives have been moving around his body. He said the hives had little red bumps, saying the hives were itchy. Therapeutic measures (Zyrtec and Hydrocortisone Cream) were taken as a result of hives from his knee to his chest, and from his chest to his arm and to his neck area, hives had little red bumps and were itchy (urticaria). The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/23/2021,2.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Urticaria'],1,PFIZER\BIONTECH, 1051374,MN,36.0,F,"I'm currently 20 hours post administration of my 2nd dose and feel lousy; light nausea approx 2 hours after adminstration; dull headache and intense body aches approx 8 hours after administration; dull headache and intense body aches approx 8 hours after administration; This is a spontaneous report from a contactable other hcp. A 36-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), intramuscular on the left arm at the age of 36 years, on 26Jan2021 12:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included anaphylactic reaction, drug hypersensitivity to penicillin, food allergy to pistachios. The patient's concomitant medications were not reported. The patient had the first dose on an unspecified date in Jan2021. On 26Jan2021, the patient experienced light nausea approx 2 hours after administration. Then developed a dull headache and intense body aches approx 8 hours after administration. The patient was currently 20 hours post administration of 2nd dose (27Jan2021) and feels lousy. There was no treatment received for the adverse events. The outcome of the event feel lousy was unknown while other events were recovered on an unspecified date in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PVT,,,"Medical History/Concurrent Conditions: Allergy to nuts (Allergies to medications, food, or other products: penicillin and pistachios - both causing anaphylaxis); Anaphylaxis (Allergies to medications, food, or other products: penicillin and pistachios - both causing anaphylaxis); Penicillin allergy (Allergies to medications, food, or other products: penicillin and pistachios - both causing anaphylaxis)",,,"['Headache', 'Malaise', 'Nausea', 'Pain']",2,PFIZER\BIONTECH,OT 1051375,NC,78.0,M,"sore arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for different patient. This is the first of two reports. A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on his left arm, via an unspecified route of administration on 19Jan2021 at a single dose for covid-19 immunization. Medical history included egg allergy, bladder cancer and surgery. There were no concomitant medications. It was reported that the patient had a sore arm after getting the shot. The outcome of the event was recovered on an unspecified date in Jan2021. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106756 same drug, same event and different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Bladder cancer; Egg allergy; Surgery,,,['Pain in extremity'],UNK,PFIZER\BIONTECH, 1051376,FL,57.0,F,"arm is sore; pain in her chest as she had before/pain in chest to her left upper sternal border area (under collar bone); fatigued; chills; fever; body aches, it was more like body cramping; body aches, it was more like body cramping; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), intramuscular on the left deltoid, on 14Jan2021 07:15 at a single dose for COVID-19 immunization. The first dose was received on 28Dec2020 (lot number: EK9231), intramuscular on the left deltoid and patient experienced sore arm, and left upper (under collar bone) pain in her chest. The patient medical history was not reported. There were no concomitant medications. She received the vaccine around 7:15 in the morning and by midnight on 15Jan2021 (she works nights), she started to feel the pain. By that point, she was like ""ooh, my arm is sore"". She also started to have the same pain in her chest as she had before (pain in chest to her left upper sternal border area (under collar bone). Her doctor ordered a chest x-ray on 25Jan2021. Patient stated it was not cardiac. It's just there. The pain was annoying and she can feel it when she moves or when she goes to get up, it's an ache. Its a pain in the neck. On Friday, 15Jan2021, she was real fatigued, had chills, a little bit of a fever, and body aches. She clarified it was more like body cramping and her body hurt so bad. She over that by Sunday.All of her symptoms resolved by Sunday 17Jan2021, except for the pain she was experiencing in her chest which was still ongoing and persisting. She had taken Tylenol, Aleve, and Ibuprofen, but it doesn't resolve the pain at all. Outcome of the event of sore arm was unknown, for pain in chest was not recovered while for the remaining events was recovered on 17Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/15/2021,1.0,PVT,,,,,,"['Chest X-ray', 'Chest pain', 'Chills', 'Fatigue', 'Muscle spasms', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,OT 1051377,WI,32.0,F,"Monday-second day after=started to feel more sick, scratchy/sore throat; scratchy/sore throat; Monday-second day after=started to feel more sick, scratchy/sore throat/scratchy throat; Chest heaviness/tightness-slightly short of breath/chest tightness; Chest heaviness/tightness-slightly short of breath; Muscle aches; Minor chills; Headache; Sunday-first day after=just felt lousy, fatigue/fatigue; General malaise/ just felt lousy; Saturday night= extremely sore arm (lasted for first 24-48 hrs after); This is a spontaneous report from a contactable nurse. A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1284), intramuscular on the left arm at the age of 32 years, on 23Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included eczema and allergy to metals from an unknown date and unknown if ongoing. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient received the first dose on 02Jan2021. On Saturday night (23Jan2021), the patient's had extremely sore arm (lasted for first 24-48 hrs. Then on Sunday( 24Jan2021), patient just felt lousy and fatigue. On Monday (25Jan2021), patient started to feel more sick, scratchy/sore throat, fatigue, chest heaviness/tightness lightly short of breath, muscle aches, minor chills, headache. On Tuesday, third day after, muscle aches, headache, fatigue, general malaise, scratchy throat, chest tightness. No treatment was received for the events. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/23/2021,0.0,PVT,ZOLOFT,,Medical History/Concurrent Conditions: Eczema; Nickel sensitivity,,,"['Chest discomfort', 'Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Illness', 'Malaise', 'Myalgia', 'Oropharyngeal pain', 'Pain in extremity', 'Throat irritation']",2,PFIZER\BIONTECH,OT 1051378,MI,29.0,M,"Fever of 102.8; Chills; fatigue; head and body aches; body aches; This is a spontaneous report from a contactable consumer (patient). A 29- year-old male patient received first dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: EL3248) via unknown route of administration on left arm, at 05:45 on 01Feb2021, at single dose for COVID-19 immunization. The patient medical history included Coeliac disease and gluten allergy. The concomitant medication included finesteride, iron, biotin, niacin and zinc. The patient experienced fever 102.8 centigrade, chills, fatigue, head and body aches at 18.30 on 01Feb2021. The patient didn't receive any treatment. The patient was not diagnosed with COVID-19 prior to vaccination and after vaccination. The patient received COVID-19 vaccine at workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The events was reported as non-serious by the reporter. The outcome of the events was reported as recovered on an unknown date in Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,WRK,FINASTERIDE; IRON; BIOTIN; NIACIN; ZINC,,Medical History/Concurrent Conditions: Allergy; Celiac disease,,,"['Body temperature', 'Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 1051379,,,M,"soreness at injection site; Splitting headache for 48 hours after injection; nausea; body aches; fatigue; This is a spontaneous report from non-contactable consumer (patient). An adult male patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunisation. Medical history included asthma. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown and expiration date unknown) on 09Jan2021 for COVID-19 immunisation. The patient's concomitant medications were not reported. It was not known if the patient received other vaccines within 4 weeks prior to the COVID vaccine. It was not known if the patient was diagnosed with COVID-19 prior to vaccination. The patient experienced splitting headache for 48 hours after injection, nausea, body aches, fatigue and soreness at injection site all on 30Jan2021. The patient recovered from splitting headache on 01Feb2021 while the patient recovered from the other events on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/30/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Asthma,,,"['Fatigue', 'Headache', 'Nausea', 'Pain', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1051380,MN,48.0,F,"breakout rash on her chest, neck, and under her chin; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date: May2021), via intramuscular route of administration on 23Jan2021 at 16:25 at 0.3 mL, single for COVID-19 immunization. Medical history included allergy, penicillin allergy, allergic to bee stings, and allergic to baby powder. The patient's concomitant medications were not reported. On 23Jan2021 at 23:30, the patient had breakout rash on her chest, neck, and under her chin. She says she took Benadryl, which puts her right to sleep, and she slept 12 hours. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,01/23/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Allergy; Bee sting hypersensitivity; Penicillin allergy,,,['Rash'],1,PFIZER\BIONTECH,OT 1051381,CO,52.0,F,"fever; body aches; mild vertigo; The first dose was received on 02Dec2020 and the second dose was received on 16Jan2021; This is a spontaneous report from a contactable Other Health Professional reporting for herself. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration (left arm) from 16Jan2021 17:30 (05:30 PM) at SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Keflex and sulfa from unspecified date. Patient is not pregnant. No other vaccine was given in four weeks. Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. Concomitant medication included botulinum toxin type a (BOTOX), and ibuprofen (MOTRIN) from an unspecified date for an unspecified indication (medications in two weeks). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown) on 02Dec2020 07:45 AM, Left arm. The first dose was received on 02Dec2020 and the second dose was received on 16Jan2021. The patient experienced fever, body aches, mild vertigo on 17Jan2021 12:00. Treatment was not given. Outcome of the events was recovered in 2021. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/16/2021,01/16/2021,0.0,PVT,BOTOX; MOTRIN [IBUPROFEN],,Medical History/Concurrent Conditions: Sulfonamide allergy,,,"['Inappropriate schedule of product administration', 'Pain', 'Pyrexia', 'Vertigo']",2,PFIZER\BIONTECH, 1051382,NY,39.0,F,"metallic taste in mouth; itchy throat that felt constricted; itchy throat that felt constricted; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0142) intramuscular on the left arm on 30Dec2020 10:30 at a single dose for COVID-19 immunization. Medical history included pre-diabetes and known allergies: Penicillin. Concomitant medication included escitalopram oxalate (LEXAPRO). Immediately after the 1st dose on 30Dec2020, the patient experienced metallic taste in mouth followed by itchy throat that felt constricted. The facility where the vaccine was administered was in a hospital. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,12/30/2020,0.0,PVT,LEXAPRO,,Medical History/Concurrent Conditions: Penicillin allergy (known allergies: Penicillin); Pre-diabetes,,,"['Dysgeusia', 'Throat irritation', 'Throat tightness']",1,PFIZER\BIONTECH,OT 1051383,NY,39.0,F,"tongue numbness; weird taste; persistent allergies; itchy face; This is a spontaneous report from a contactable health care professional (patient). A 39-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL8982, expiry date unknown), via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history included pre-diabetes and allergies to penicillin both from an unknown date and unknown if ongoing. The patient concomitantly received cetirizine hydrochloride (ZYRTEC) as pre-medication and Lexi pro (as reported). The patient received the first dose of BNT162B2 (lot number: EL0142, expiry date unknown), intramuscular on 30Dec2020 at 10:30 AM on the left arm for COVID-19 immunization where the patient immediately after experienced metallic taste in mouth followed by itchy throat that felt constricted. Prior to vaccination, the patient has not had COVID-19. The patient has not been tested for COVID-19 post vaccination. The patient was premedicated with Zyrtec and 15 minutes after second dose had tongue numbness and weird tast on 20Jan2021 at 16:15 and itchy face started hours later and then continued with persistent allergies every day since the second dose until present was placed on oral steroid. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient received oral steroid and Benadryl as treatment for the events. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,PVT,ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Penicillin allergy; Pre-diabetes,,,"['Allergy to vaccine', 'Dysgeusia', 'Hypoaesthesia oral', 'Pruritus']",2,PFIZER\BIONTECH, 1051384,,29.0,F,"Site swelling and high pain for 3 days; Site swelling and high pain for 3 days; Global Migraines; Irritated; This is a spontaneous report from a non-contactable nurse (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9262) via an unspecified route of administration on the left arm on 21Jan2021 22:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 31Dec2020 for COVID-19 immunization. On 22Jan2021 03:00 AM, the patient experienced site swelling and high pain for 3 days. Global Migraines that I have never hard before 2 days after vaccination and irritated. Events treatment included paracetamol (TYLENOL), cetirizine (ZYRTEC) and diphenhydramine (BENADRYL). Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/22/2021,1.0,WRK,,,,,,"['Irritability', 'Migraine', 'Vaccination site pain', 'Vaccination site swelling']",2,PFIZER\BIONTECH, 1051385,MO,,F,"Soreness at injection site; sore throat; cough; fever for two nights (101 [unit unspecified]/100 [unit unspecified]); This is a spontaneous report from a contactable consumer (patient). An elderly non-pregnant female patient (reported as 65 [unit unspecified]) received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9263; expiration date: unknown) unknown age of vaccination via an unspecified route of administration left arm on 23Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included had covid-19 prior vaccination (if covid prior vaccination: yes). Concomitant medication includes unspecified medications. The patient did not received vaccination in four weeks. The patient received the vaccine in a hospital. On 24Jan2021 09:00 AM, the patient had soreness at injection site, sore throat, fever for two nights (101 [unit unspecified] on 24Jan2021 and 100 [unit unspecified] on 25Jan2021) and cough. The patient did not received treatment for the adverse events. The patient has not been covid tested post vaccination. The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/24/2021,1.0,PVT,,,Medical History/Concurrent Conditions: COVID-19 (If covid prior vaccination: Yes),,,"['Body temperature', 'Cough', 'Oropharyngeal pain', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1051386,AR,52.0,F,"Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 26Jan2021 (09:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included anemia and allergies. Concomitant medications included an unspecified allergy shot. The patient was not pregnant at the time of vaccination. On 26Jan2021 (12:15), the patient had felt pains; lymph nodes had swelled; had pain on tongue; extreme dehydration; fatigue; and difficulty swallowing. The patient had received diphenhydramine (BENADRYL) as treatment for the events, and drank lots of water. The outcome of the events, 'felt pains', 'lymph nodes swelled', 'pain on tongue', 'extreme dehydration', 'fatigue' and 'difficulty swallowing', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,PHM,,,Medical History/Concurrent Conditions: Allergy; Anemia,,,"['Dehydration', 'Dysphagia', 'Fatigue', 'Glossodynia', 'Lymphadenopathy', 'Pain']",UNK,PFIZER\BIONTECH, 1051387,VA,,M,"Rash and swelling in hands; Rash and swelling in hands; Blisters; This is a spontaneous report from a contactable healthcare professional (patient). An adult male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176; Expiration date was not reported) on 13Jan2021 (12:00) at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient did not have relevant medical history and concomitant medications. On 15Jan2021, the patient had rash and swelling in hands; and blisters. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had received valacyclovir as treatment for the reported events. The outcome of the events, 'rash and swelling in hands' and 'blisters', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/15/2021,2.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Blister', 'Peripheral swelling', 'Rash']",1,PFIZER\BIONTECH, 1051388,NC,74.0,F,"swollen neck lymph nodes five days after shot; My left arm was swollen; low grade fever; This is a spontaneous report from a contactable consumer reporting for herself. A 74-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1283), via an unspecified route of administration (left arm) on 21Jan2021 15:00 at SINGLE DOSE for covid-19 immunisation. Medical history included cholesterol (abnormal) from an unknown date. Patient is not pregnant. No other vaccines were given in four weeks. Patient did not have COVID prior vaccination and patient was not tested for COVID post vaccination. Concomitant medications (medications in two weeks) included pravastatin from unspecified date for cholesterol (abnormal); estrogens conjugated (PREMARIN), allopurinol (ELAVIL), ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10), aminobenzoic acid, biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (B COMPLEX) from an unspecified date for an unspecified indication. The patient experienced low grade fever on 25Jan2021 that went away but the following morning on 26Jan2021, the patient also experienced swollen neck lymph nodes five days (five days as reported) after shot. Patient stated she does not know if it was going away. Patient's left arm was also swollen on 26Jan2021. Left arm was described as swollen just little bit, not much but that's gone down. The patient stated there was no fever as of reporting, but the swollen lymph node was being reported and since she has been up, it's gone down considerably but she can just feel them a little bit on her neck. Treatment was not given. She mentioned she has a person coming to do a work at the house and wanted to know if it is okay if she still comes. She asked if she should be alarmed about the side effect. She mentioned she was just concerned about if she needs to be concerned about this or if she can be around people. She mentioned she wear masks anyways but just need to know if it is okay if people come into her home. Outcome of the events low grade fever and left arm was swollen was recovered on Jan2021, while unknown for swollen neck lymph nodes five days after shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/25/2021,4.0,UNK,PRAVASTATIN; PREMARIN; ELAVIL [ALLOPURINOL]; COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECA; B COMPLEX [AMINOBENZOIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE;CYANOCOBALAMIN;FO,,Medical History/Concurrent Conditions: Blood cholesterol abnormal,,,"['Body temperature', 'Lymphadenopathy', 'Peripheral swelling', 'Pyrexia']",1,PFIZER\BIONTECH, 1051389,NY,51.0,F,"joint pain; muscle ache; fatigue; This is a spontaneous report received from a contactable consumer. A 51-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration, on 04Jan2021 (lot number and expiry date unknown), at single dose; then received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration, on 25Jan2021 (lot number and expiry date unknown), at single dose, for COVID-19 immunization. Medical history included type 2 diabetes mellitus (reported as ""t2dm""). The patient did not have COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccines in four weeks. The patient experienced joint pain, muscle ache and fatigue in Jan2021. Treatment for the events included APAP. The patient was tested for COVID-19 post vaccination in Jan2021 thru nasal swab with unknown results. The patient was recovering from the events. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Type 2 diabetes mellitus,,,"['Arthralgia', 'Fatigue', 'Myalgia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1051390,NJ,,U,"Heart palpitations for three days after injection; Cold symptoms for three days after injection; This is a spontaneous report from a non-contactable consumer. A 26-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm on 08Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced heart palpitations and cold symptoms for three days after injection on 08Jan2021. No treatment was received for the events. The outcome of the event was recovered on an unspecified date. No follow up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,,,,,,"['Nasopharyngitis', 'Palpitations']",1,PFIZER\BIONTECH, 1051391,OH,36.0,F,"Hives that itched and burned on my head; Hives that itched and burned on my head; Hives that itched and burned on my head; Rash to my face; Body aches; weakness; fatigue and woozy feeling xs 4 days; fatigue and woozy feeling xs 4 days; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EJ1686) via an unspecified route of administration on the left arm on 20Jan2021 23:15 at a single dose for COVID-19 immunization. Medical history included Raynaud's, hypotension, known allergies: barley, oatmeal, pork, tomatoes. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient previously took doxycycline and experienced allergies. Benadryl prior to administration. On 20Jan2021 03:00 PM, the patient experienced hives that itched and burned on her head - still remain after 6 days but improved. Rash to her face, body aches, weakness, fatigue and woozy feeling for 4 days. Events treatment included diphenhydramine (BENADRYL). The facility where the vaccine was administered was in a nursing home/senior living facility. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID test post vaccination included Nasal Swab (Rapid and PCR) on 21Jan2021: negative. Outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,SEN,BENADRYL,,Medical History/Concurrent Conditions: Allergy to grains; Hypotension; Meat allergy; Raynaud's disease; Vegetable allergy,,,"['Asthenia', 'Burning sensation', 'Dizziness', 'Fatigue', 'Pain', 'Pruritus', 'Rash', 'SARS-CoV-2 test', 'Urticaria']",1,PFIZER\BIONTECH, 1051392,CA,,M,"Muscle aches; overnight chills; This is a spontaneous report from a non-contactable pharmacist. A 41-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient describes muscle aches and overnight chills after receiving the 2nd COVID19 vaccine injection on 25Jan2021. No treatment was received for the events. The outcome of the events was recovered in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,PVT,,,,,,"['Chills', 'Myalgia']",2,PFIZER\BIONTECH, 1051393,WA,59.0,F,"Very painful arm 6-14 hours after injection; one hive on left forearm; pain and pressure in head through today; pain and pressure in head through today; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 20Jan2021 07:45 AM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccines weeks prior to receiving bnt162b2. The patient was not pregnant. Prior vaccination, the patient was not diagnosed with covid. Medical history included prone to headaches. She had no known allergies. Concomitant medications included clarithromycin (CLARITIN), dextroamphetamine [dexamfetamine], fish oil, and ""Olly multivit"". On 20Jan2021 02:00 PM, the patient experienced very painful arm 6-14 hours after injection; one hive on left forearm; pain and pressure in head through today, Day 6 after vaccine, and counting. No corrective treatment was received. Outcome of the events was not recovered. The patient was not tested for covid post vaccination. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,PVT,CLARITIN [CLARITHROMYCIN]; DEXTROAMPHETAMINE [DEXAMFETAMINE]; FISH OIL,,Medical History/Concurrent Conditions: Headache,,,"['Head discomfort', 'Headache', 'Urticaria', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1051394,TN,48.0,F,"red rash over her torso including her back and lower stomach and a slight rash on her arms and legs; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN5318) in a Public Health Clinic, via an unspecified route of administration on 21Jan2021 at 16:00 at a single dose on the left arm for COVID-19 immunization. Medical history included diabetes and high blood pressure both from an unknown date and unknown if ongoing. The patient had COVID-19 prior to vaccination on an unspecified date. The patient had no known allergies. The patient has not been tested for COVID-19 post vaccination. Concomitant medication included metformin hydrochloride, pioglitazone hydrochloride (ACTOPLUS MET), olmesartan medoxomil (BENICAR), loratadine (CLARITIN) and montelukast sodium (SINGULAIR). The patient had red rash over her torso including her back and lower stomach and a slight rash on her arms and legs on 24Jan2021 at 12:00. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient was administered a steroid shot by her primary physician as treatment for the event. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/24/2021,3.0,PUB,ACTOPLUS MET; BENICAR; CLARITIN [LORATADINE]; SINGULAIR,,Medical History/Concurrent Conditions: Blood pressure high; COVID-19; Diabetes,,,['Rash erythematous'],UNK,PFIZER\BIONTECH, 1051395,KY,48.0,F,"chills; headache; sore throat; nausea; Loss of smell; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), intramuscularly on the right arm, on 05Jan2021 10:00, at single dose, for covid-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Concomitant medications included omeprazole; metoprolol; methocarbamol; vitamin d3; pregabalin; and levothyroxine. The patient did not have Covid prior vaccination. The vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. With the first shot the patient experienced chills, headache, sore throat, nausea and, loss of smell - all on 08Jan2021. These adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for these adverse events. At the time of the report, the patient was recovering from the events. The patient had a nasal swab for Covid on 11Jan2021 with results of negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/08/2021,3.0,PVT,OMEPRAZOLE; METOPROLOL; METHOCARBAMOL; VITAMIN D3; PREGABALIN; LEVOTHYROXINE,,,,,"['Anosmia', 'Chills', 'Headache', 'Nausea', 'Oropharyngeal pain', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1051396,FL,65.0,M,"synovitis bilateral hands; This is a spontaneous report from a contactable other health professional. A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had unspecified concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 11Jan2021, the patient had synovitis bilateral hands. The patient received an unspecified steroids as treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered. No follow-up attempts are possible; Information about lot/batch could not be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/11/2021,2.0,PVT,,,,,,['Synovitis'],1,PFIZER\BIONTECH, 1051397,,36.0,M,"Low grade fever (100 degrees); Chills; aches; fatigue; This is a spontaneous report from a contactable consumer reported for himself. A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EL3248), on right arm via an unspecified route of administration on 01Feb2021 13:15 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2, (Lot no: EL3248) on 13Jan2021 01:15 pm for covid-19 immunisation. On 02Feb2021 12:00 AM patient experienced low grade fever (100 degrees), chills, aches and fatigue. Outcome of the events was recovered on unspecified date in 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/02/2021,1.0,WRK,,,,,,"['Body temperature', 'Chills', 'Fatigue', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1051398,MA,24.0,F,"A slight fever on the day after injection.; Pain in left arm at injection site as well as soreness in left arm as a whole; Pain in left arm at injection site as well as soreness in left arm as a whole.; A Migraine on day of injection as well as the following day; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date unknown), via an unspecified route of administration on left arm on 01Feb2021, at 09:15 AM at the age of 24 years old at a single dose for Covid-19 immunization in the hospital. Patient was not pregnant at the time of vaccination. The patient's medical history included complex aphthosis. Concomitant medications included probiotics. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received probiotics within 2 weeks of vaccination. On 01Feb2021 at 11:00, the patient experienced pain in left arm at injection site as well as soreness in left arm as a whole. A Migraine on day of injection (01Feb201 at 11:00) as well as the following day. On 02Feb2021, on the day after injection a slight fever. The patient assessed the events as non-serious. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the events on an unspecified date in Feb2021. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Aphthous ulcer,,,"['Migraine', 'Pain in extremity', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1051399,PA,28.0,F,"Little shortness of breath; Dizzy; very tired; Chills; Stiff neck/ head and neck are very stiff; Felt crummy; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 21Jan2021 at a single dose on the left arm to be prevented from COVID 19. The patient's medical history included COVID from 04Dec2020 and after that, on unspecified date, COVID test was negative. Concomitant medication was reported as none. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Dec2020 on the right arm at 28- years of age to be prevented from COVID 19. On 21Jan2021, the patient had what everyone was talking about, the chills and stiff neck, she felt crummy, muscle aches, thought it was the normal. The next day (22Jan2021), she had a little shortness of breath, she felt dizzy on and off and her head and neck are very stiff, and she is very tired. The outcome of the events stiff neck/ head and neck are very stiff, felt crummy, and dizzy was not recovered while the other events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,UNK,,,"Medical History/Concurrent Conditions: COVID-19 (and after that, on unspecified date, COVID test was negative)",,,"['Chills', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Malaise', 'Musculoskeletal stiffness', 'Myalgia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1051400,MI,56.0,M,"24 hours of flu like body aches; extreme tiredness; Sore shoulder; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date unknown), via an unspecified route of administration on left arm at the age of 56 years old on 02Feb2021 at 14:30 at a single dose for COVID-19 immunisation at workplace clinic. The patient's medical history was not reported. Allergies to medications, food, or other products was none. Concomitant medications included atorvastatin calcium (LIPITOR), hydrochlorothiazide, irbesartan (AVALIDE), famotidine and amlodipine besilate (NORVASC). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date unknown) on left arm on 12Jan2021 at 07:00 AM for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced sore shoulder, 24 hours of flu like body aches and extreme tiredness all on 02Feb2021 at 04:30 AM. The patient assessed the events as non-serious. No treatment was received in response to the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has recovered from flu like body aches on 03Feb2021 while the patient recovered from the sore shoulder and extreme tiredness on an unspecified date in Feb2021. The information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,WRK,LIPITOR [ATORVASTATIN CALCIUM]; AVALIDE; FAMOTIDINE; NORVASC,,,,,"['Arthralgia', 'Fatigue', 'Influenza like illness']",2,PFIZER\BIONTECH, 1051401,MI,28.0,M,"Soreness at injection site; Following morning experienced headache and fatigue throughout day; Following morning experienced headache and fatigue throughout day; queasiness; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248, Expiry date: unknown) at 28 years of age via an unspecified route of administration on the right arm on 01Feb2021 at 09:15 am at a single dose for COVID-19 immunisation. Medical history and some surgeries were none. The patient has no allergies to medications, food, or other products. Concomitant medications included fluticasone propionate (50mcg) nasal spray and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM). The patient previously took the first dose of BNT162B2 (lot number: EL3248, expiry date: unknown) on 12Jan2021 at 08:30 am on left arm for COVID-19 immunisation. The patient experienced soreness at injection site. Following morning experienced headache and fatigue throughout day. Some queasiness possibly related to vaccine. Following day, it was reported that the only remaining symptom is a slight headache. The events were assessed as non-serious by the reporter. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the events. The patient was recovering from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/02/2021,1.0,WRK,FLUTICASONE PROPRIONATE; VITAM,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none, Comment: Other medical history: None / some surgeries / None",,,"['Fatigue', 'Headache', 'Nausea', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1051402,PA,83.0,F,"she woke up and noticed everything was spinning; Dizzy; sore arm after the shot.; Swollen arm; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) on his right arm, via an unspecified route of administration on 22Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included blood pressure high and surgery. There were no concomitant medications. Historical vaccine included a flu shot for flu immunization and experienced arm is sore and pain. The patient reported she got the COVID shot last Friday at 3pm. That night she woke up at 2am and everything was spinning. She is better now but not completely. If she lies down and gets up or turns her head a certain way, she gets dizzy. She had a swollen arm and sore arm after the shot. No treatment was received for the events. The outcome of the events swollen arm and sore arm was unknown while recovering for the other events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/01/2021,,UNK,,Blood pressure high,Medical History/Concurrent Conditions: Surgery,,,"['Dizziness', 'Pain in extremity', 'Peripheral swelling', 'Vertigo']",1,PFIZER\BIONTECH, 1051403,NC,72.0,F,"she just does not feel good; Feeling like she is getting a cold; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female received the first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283 and expiry date: 30Apr2021), via an unspecified route of administration on the right arm, on 22Jan2021 at 0.3 mL, single for COVID-19 immunization. There were no medical history and concomitant medications. Patient stated she was feeling like she was getting a cold. She clarified that she started feeling this way starting last night on 25Jan2021, and today on 26Jan2021, she just does not feel good. Outcome of the events was not recovered. The reporter considered the events non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/25/2021,3.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE,,,"['Malaise', 'Nasopharyngitis']",1,PFIZER\BIONTECH, 1051404,NV,45.0,F,"dyspnea; rash; severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: Ek5760, via an unspecified route of administration in the right arm, on 19Dec2020 17:00 at SINGLE DOSE for covid-19 immunization. The patient's medical history included urticaria and folliculitis: patient was under successful treatment for urticaria and folliculitis with near resolution. Concomitant medication included cefalexin (KEFLEX), cefdinir, fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC) and triamcinolone. The patient received BNT162B2 on 19Dec2020. Then on 29Dec2020, 12:00, severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); experienced rash and dyspnea requiring steroids and epipen. The adverse event resulted in a doctor or healthcare professional office/clinic visit. The patient's labs on an unknown date was negative for autoimmune disease. The patient was recovering from all events. Treatment for the events included Prednisone course, epipen, and H2 blockers. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on the temporal relationship and known safety profile of BNT162B2, the reasonable possibility of an association between rash, dyspnea and suspect product cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,12/29/2020,10.0,PVT,KEFLEX [CEFALEXIN]; CEFDINIR; ALLEGRA; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TRIAMCINOLONE,,Medical History/Concurrent Conditions: Folliculitis (patient was under successful treatment for urticaria and folliculitis with near resolution); Urticaria (patient was under successful treatment for urticaria and folliculitis with near resolution),,,"['Condition aggravated', 'Dyspnoea', 'Folliculitis', 'Investigation', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH, 1051405,TX,59.0,F,"soreness in arm; achiness; Covid testing was positive/diagnosed with Covid-19; pulse ox 92 (lowest level); tightness in chest (no productive cough); This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at the left arm on 10Jan2021 09:00 (lot number EJ1686 and expiry date unknown) at single dose for Covid-19 immunization in a hospital and not in a military facility. Medical history included asthma. Concomitant medications included albuterol [salbutamol] from unspecified date for unspecified indication. Historical vaccine included flu shot in Oct2020 for immunization and experienced some soreness in arm and achy. The patient was not given other vaccines given the same day or 4 weeks prior. In Jan2021, the patient had some soreness in arm and achiness (Jan2021) after the Pfizer BioNTech Covid-19 vaccine it didn't last long and she went to work afterwards. The patient was scheduled for work the next day and could tell something was not right. The patient was flushed and thought it was from the Albuterol since it can cause a racing heart beat and checked for a fever and didn't' have one. The patient checked temperature before bed and it was 100.5 degrees and she went straight to (redacted). The patient informed that she went for Covid testing; she went to physician office for Covid testing. The patient was praying for the flu so she could take Tamiflu and the flu test was negative (21Jan2021) and the Covid testing was positive (21Jan2021). The patient was tested positive after first Covid vaccine and ran fever 8 to 9 days and highest temperature was 101 degrees, had a little bit of asthma and kept a close watch, congestion, pulse ox 92 (lowest level), tightness in chest (no productive cough), felt beat up, fatigued and tiredness. The patient was diagnosed with Covid-19. She was told as well not to take pain relievers (ibuprofen, Advil and Aleve) and was advised to take Tylenol instead. The patient informed that she was to get her second dose tomorrow. The patient wanted to know if she can get the second dose if she was tested positive. The patient was supposedly scheduled to have the second dose on 27Jan2021 however it was moved to 04Feb2021 due to tested positive of Covid and was put on quarantined. The outcome of the events was recovering. The patient was unable to provide seriousness criteria when queried and said that this was her luck of the draw. The patient thought the shot actually helped.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/01/2021,,PVT,ALBUTEROL [SALBUTAMOL],,Medical History/Concurrent Conditions: Asthma,,,"['Body temperature', 'COVID-19', 'Chest discomfort', 'Influenza virus test', 'Oxygen saturation', 'Oxygen saturation decreased', 'Pain', 'Pain in extremity', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1051406,WI,71.0,F,"Got nervous feeling; Allergic reaction to bee sting; rash of heat from her neck up to her head; noticed a feeling of needing to swallow and figured out it was just a knee jerk reaction to make sure she can swallow/still having the swallowing; Congested head, head felt congested, not like pressure; Fingertips a little numb and tingling; Fingertips a little numb and tingling; This is a spontaneous report from a contactable consumers (one is the patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269), via an unspecified route of administration on 03Feb2021 at 10:40 at a single dose on the right arm for COVID-19 immunization, ibuprofen (manufactured by other company, strength: 200 mg, lot number: 7AE1784B, expiry date: Nov2018), oral from an unspecified date and ongoing at 400 mg, as needed for an unspecified indication, hydrochlorothiazide (strength: 25 mg), oral from an unspecified date and ongoing at 25 mg, once a day (about 8am) for high blood pressure, and valsartan (strength: 160 mg, expiration date: 11Nov2021), oral from an unspecified date and ongoing at 160 mg, once a day (about 8am) for high blood pressure. Medical history included ongoing high blood pressure. The patient's concomitant medications were not reported. The patient previously took flu shot about 15-20 years ago for immunization and experienced swelling. On 03Feb2021, patient received the vaccine. When going home, she noticed all of a sudden a rash of heat from her neck up to her head. Figured it was not a problem to have a little reaction and thought nothing of it. She had a cup of coffee this morning and not a lot of water, so she started drinking water and had 3 bottles. After the heat passed she noticed a feeling of needing to swallow and figured out it was just a knee jerk reaction to make sure she can swallow. She is still having the swallowing and is continuing to drink water even at home. She also congested head, head felt congested, but not like pressure. She does not get headaches so she guesses she is getting this instead of a headache. She noticed her fingertips feel a little numb and tingling, but overall feels okay. She mentioned that on an unspecified date, she just got this nervous feeling and had allergic reaction to bee sting. Mentioned that her husband and brother in law got the shot and were feeling fine. No further details provided. The action taken in response to the events for ibuprofen was dose not changed , for hydrochlorothiazide was dose not changed, and for valsartan was dose not changed. The outcome of the event rash of heat from her neck up to her head was recovering; event got nervous feeling was unknown, while the other events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/03/2021,0.0,UNK,HYDROCHLOROTHIAZIDE; HYDROCHLOROTHIAZIDE; IBUPROFEN,Blood pressure high,,,,"['Allergy to arthropod sting', 'Hyperreflexia', 'Hypoaesthesia', 'Miliaria', 'Nervousness', 'Paraesthesia', 'Upper respiratory tract congestion']",UNK,PFIZER\BIONTECH, 1051407,HI,,F,"terrible headache/Her head was pounding; fatigue; injection site soreness; soreness; Her head was pounding, and she was having a hard time concentrating; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable female consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took sumatriptan succinate for migraine. She had the first shot of the Pfizer covid vaccine on Saturday since then, she's had soreness. She of course had injection site soreness and fatigue 48 hours after the shot. Today (01Feb2021) she also has a terrible, terrible headache. She was asking if she can take her previous migraine medication called Sumatriptan Succinate tablet. Her head was pounding, and she was having a hard time concentrating. The outcome of events was unknown. Follow-up attempts are completed. The following information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,02/01/2021,2.0,UNK,,,,,,"['Disturbance in attention', 'Fatigue', 'Headache', 'Pain', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1051408,CT,79.0,M,"rash worsened; compromised immune system with the Multiple Myeloma/ getting the COVID-19 Vaccine; compromised immune system with the Multiple Myeloma/ getting the COVID-19 Vaccine; This is a spontaneous report from a contactable nurse for her husband. A 79-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration at left arm on 26Jan2021 06:00 at single dose for covid-19 immunisation. Medical history included plasma cell myeloma from Oct2018, a compromised immune system with the Multiple Myeloma, rash from Dec2020 and ongoing. The patient had a diagnosis of multiple myeloma and had developed a slight rash on his left arm to lenalidomide (REVLIMID) before receiving the COVID vaccine, Benadryl was taken and after 3 days, it was gone. It was only on his upper arms. She said a rash was a known side effect of the lenalidomide. The nurse giving his vaccine shot noticed his slight rash on his left arm. Concomitant medication included lenalidomide (REVLIMID) for 2.5 years for multiple myeloma in remission. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The past drug included bortezomib (VELCADE), the patient was administered a chemo agent (bortezomib) at the oncology center every 2 weeks and the oncology center held off giving his chemo shot 2 weeks before he received his first COVID-19 Vaccine on 26Jan2021. The reporter said her husband would not restart the chemo shot until he sees his oncologist again. She clarified her husband has now been off the bortezomib for a month, as of 01Feb2021. The patient experienced rash worsened on 28Jan2021. By 28Jan2021 the rash had spread to his trunk and by 29Jan2021 to his back. She clarified his rash was a dry rash, with no blisters or oozing. Her first thought was to get an ointment or a spray. He has now been given prednisone instead of a dose pack and the rash was gone/ the rash cleared up almost immediately and will stop lenalidomide for a couple weeks and continue the round of prednisone. The doctor could alter his therapy as needed. On 04Feb2021, the rash was gone but her husband's doctor wants him to finish his prescribed course of Prednisone. She clarified the Prednisone (manufacturer: Actavis) 40 mg was started on 01Feb2021, the rash started fading fast. By the next day (Tuesday, 02Feb2021) the rash was really fading, and now (04Feb2021) the rash was totally not there. The doctor told her husband to take one Benadryl, and to continue taking the Benadryl if his rash itches. She said her husband's latest blood work didn't indicate anything. She said her husband's labs were always off, but were normal for having Multiple Myeloma. Both doctors want to keep her husband off of the lenalidomide. Reporter seriousness was reported as medically significant . The patient was treated for Multiple Myeloma for the past 2-1/2 years. He had been doing well, and his cancer doctors approved of him getting the COVID-19 Vaccine. The oncologist wanted her to call Pfizer to see if she can find anything about the COVID-19 Vaccine and how it pertains to the lenalidomide and her husband's Multiple Myeloma. She said her husband was almost 80 years old and very active. She said her husband had been in remission Multiple Myeloma for a year and his blood work was fine. By the time her husband starts taking lenalidomide again, he would be off of lenalidomide for almost 4 weeks. She said her husband's oncologist said he was going to cut back her husband's lenalidomide milligram dose and change his lenalidomide frequency to every other day when he resumes the lenalidomide. The reporter checked her husband's blood pressure (130/76) on 29Jan2021, after his rash worsened. She saidnot require a visit to emergency room or physician office. The rash event outcome his pulse was fine, and she tested his blood sugar and it was fine. She said he had no temperature, clarifying his temperature was 97.6. The event did was recovering. The drug result was reported as unrelated. The reporter and her husband's doctors don't think his rash has anything to do with the COVID-19 Vaccine. The patient asked if Pfizer can point her in any direction with regard to her husband's situation. She said she read the COVID-19 Vaccine is a dead virus, but wants to know if her husband should be cautious in getting the second COVID-19 Vaccine dose. She said her husband's doctors know that the rash was not precipitated by the COVID-19 Vaccine, but his rash did get worse after he got the first COVID-19 Vaccine dose. His second dose was due 16Feb2021. The reporter was wondering if she should delay the second dose of the vaccine, the vaccine would make the rash worse.; Sender's Comments: Based on the information currently provided, the rash worsened after 2 days following the vaccine use thus a contributory role of BNT162B2 might not be fully excluded towards the event onset. Severe allergic reaction is the known risk for the product and Rash faded soon under Prednisone. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,PVT,REVLIMID,Rash,Medical History/Concurrent Conditions: Immune system disorder; Multiple myeloma,,,"['Blood glucose', 'Blood pressure measurement', 'Blood test', 'Body temperature', 'Heart rate', 'Investigation', 'Off label use', 'Product use issue', 'Rash']",1,PFIZER\BIONTECH, 1051410,NC,74.0,F,"uncomfortable all night; itching; hives all over my body/developed giant hives all over her body/the giant hives were like fire ant bites/developed little hives on the inside of her arms, behind her knees, and on the tops of her feet; This is a spontaneous report from a contactable health care professional nurse, the patient. A 74-years-old female patient (retired nurse) received the first dose of bnt162b2 (BNT162B2, Lot Number EL9262) , via an unspecified route of administration in the right deltoid on 29Jan2021 at 11:00 (at 74 years of age) as a Single dose for Covid-19 Vaccination. The Vaccination Facility was 'movie theater'. No other vaccines were given within 4 weeks. Medical history included hypertension from 2020 ( doctor considered taking her off of blood pressure medicine because her blood pressure is very normal now), Prediabetes (diagnosed with Prediabetes about 3 years ago) and Allergic reaction to bee sting (numerous yellow jacket stings throat felt like it was starting to close, and tongue felt funny. Went to ER and Treated with Zantac and Epinephrine) and lost 55 lbs. (borderline high blood pressure was related to her weight). Concomitant medication included ongoing generic losartan (LOSARTAN) 50 mg, 1x/day for borderline high blood pressure, metformin (METFORMIN) 500 mg, 1x/day for glucose tolerance impaired. On 29Jan2021at 5 PM the patient started having some itching 'felt like she had a mosquito bite but on further investigation she noticed ""giant hives all over my body'. She said she took some Benadryl Lot Number: P119923 Expiration Date: Apr2023 and 1 expired Zantac (Lot Number: NL4604, Expiration Date: Nov2019) on 29Jan2021 to help treat giant hives and itching. The giant hives 'kind of subsided' after she took the Benadryl and the Zantac, though she did remain itchy and uncomfortable all night. She said by the morning (30Jan2021) the giant hives were gone. She said that evening (30Jan2021) the giant hives came back again, and the giant hives were all over her body. She said the giant hives were like fire ant bites, she said the giant hives were just awful. She said she had a previously scheduled appointment with her doctor on Monday, 01Feb2021 (prior to developing the giant hives after her first COVID-19 Vaccine dose) but probably would have gone to see her doctor anyway, if she didn't have a prior appointment. She said she had taken pictures of her giant hives, her doctor believes the giant hives she experienced was a reaction the COVID-19 Vaccine's preservatives. She said her doctor still wants her to get the second COVID-19 Vaccine dose. Consumer stated Reported her giant hives were gone by Monday morning (01Feb2021), when she woke up. She stated during Monday (01Feb2021) into Tuesday (02Feb2021) she developed little hives on the inside of her arms, behind her knees, and on the tops of her feet. She said she has a residual itching that is lingering, but not continual. She said she has been taking one generic Zyrtec 10mg tablet per day, Lot Number: NL4604, Expiration Date: Nov2019. The events Hives and Itching was medically significant and uncomfortable was non serious. Treatment was given for itching and hives. Her doctor still wants her to get the second COVID-19 Vaccine dose. Patient second COVID-19 Vaccine dose is scheduled for 19Feb2021. The patient reported her doctor told her it would be a good idea for her to take one Zyrtec, each day, for 3 days before her next COVID-19 Vaccine dose. She said her doctor told her to pre-medicate with Benadryl on the day of her second COVID-19 Vaccine dose. The clinical outcome of Pruritus was recovering while Hives was recovered on 02Feb2021 and the outcome of uncomfortable was unknown. The events Giant hive, hives and itching were considered related to the suspect product.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,UNK,LOSARTAN; METFORMIN,,"Medical History/Concurrent Conditions: Allergic reaction to bee sting (throat felt like starting to close/ tongue felt funny. ER given Zantac and Epinephrine.); Blood pressure high (doctor considered taking her off of BP medicine because her BP is very normal now); Prediabetes (diagnosed with Prediabetes about 3 years ago,); Weight loss (borderline high BPwas related to her weight. She clarified she has lost 55 lbs)",,,"['Discomfort', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH, 1051411,FL,67.0,F,"nausea; felt tired; Rash is red and she can feel bumps; rash is red and she can feel bumps; pain at the injection site; itching going on in my face, my left arm, in the elbow / stomach about 2 inches to the left where they made the incision for the cancer removal; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL9269), via an unspecified route of administration into left arm on 06Feb2021 (at the age of 67-years) as a single dose for COVID-19 immunization. Medical history included allergic to peanuts, allergic to Penicillin, cancer and hysterectomy. There were no concomitant medications. The patient previously took vancomycin, cefalexin (KEFLEX) and zelnorm and was allergic. On 06Feb2021, the patient had pain at the injection site, but that was gone now. She also experienced rash, which was elaborated as an itch, like a rash that started since she got the shot. She had the itching rash going on into her face, left arm, the elbow, and also 2 inches from naval on the left side where she had incision from cancer removal, hysterectomy. The rash was started in the area of the hysterectomy. The patient elaborated that the rash was red and she can feel bumps. The patient was taking diphenhydramine hydrochloride (BENADRYL) which usually stop the itching. Last night 06Feb2021, the back of her left elbow and her face started itching as well and at 23:30 the patient experienced nausea and felt tired. The patient is scheduled for second dose on 27Feb2021. The clinical outcome of event rash is red and she can feel bumps was not recovered. The outcome of pain at the injection site was recovered in Feb2021. The clinical outcome of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/06/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Cancer; Hysterectomy; Peanut allergy; Penicillin allergy,,,"['Fatigue', 'Nausea', 'Pruritus', 'Rash erythematous', 'Rash papular', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1051412,,,F,"they both have covid; they both have covid; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (herself and her husband). This is first of two reports. A female patient of an unspecified age (reported as 70, unit unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history included pneumonia. The patient's concomitant medications were not reported. The patient reported that she received the first dose of the Pfizer COVID vaccine on 18Jan2021, and her husband on 20Jan2021. She was diagnosed with COVID last Thursday (04Feb2021). She said she got it from her husband. They both have COVID and received antibodies (from (company name)) as it was mild case. She said she and her husband were congested, had fatigue, and the antibodies made a difference. She had pneumonia before. The patient stated so many people can only take the first dose due to side effects or some other reason. She wanted to know the time they needed to wait to get the second dose of the vaccine and asked if it was 90 days. The outcome of the event was unknown. Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171730 Same reporter, drug, and events; different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,02/04/2021,17.0,UNK,,,Medical History/Concurrent Conditions: Pneumonia (she had pneumonia before.),,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1051413,,30.0,F,"Pain at the injection site that started about 3hrs after injection; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3247, first dose) solution for injection intramuscular on an unknown date (at the age of 30-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced pain at the injection site that started about 3 hours after injection. No treatment was provided for the event pain at the injection site. The outcome of the event pain at the injection site was unknown. The patient was not tested for COVID post vaccination. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH,OT 1051414,NJ,57.0,F,"I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere; my heart was pounding so fast; dizzy; seeing blurry; tongue was stinging; eye lids were burning; I didn't feel right the whole rest of the night.; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/212080597001), the first dose, via an unspecified route of administration on 31Dec2020 18:30 at single dose for covid-19 immunisation. Medical history included High Cholest. Type 2 Diabetes, High Blood Pressure, Fatty Liver, Overweight, and allergies to medications: Penicillin. Concomitant medication included levothyroxine sodium (UNITHROID), olmesartan medoxomil (BENICAR), rosuvastatin, empagliflozin, linagliptin (GLYXAMBI), escitalopram oxalate (LEXAPRO). After injections (on 31Dec2020) when to sit down, suddenly all over my body under my skin was burning everywhere and my heart was pounding so fast I thought it was going to come out of my chest. I got dizzy and was seeing blurry. At the end my tongue was stinging and my eye lids were burning. I felt like I was going to pass out. Then finally subsided but I didn't feel right the whole rest of the night.Therapeutic measures were taken as a result of all events. The outcome of events was recovered.Prior to vaccination, the patient did not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. The case considered non-serious (Seriousness criteria-Results in death: No;Life threatening: No;Caused/prolonged hospitalization: No;Disabling/Incapacitating: No;Congenital anomaly/birth defect:No). Follow-up attempts are completed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/31/2020,12/31/2020,0.0,WRK,UNITHROID; BENICAR; ROSUVASTATIN; GLYXAMBI; LEXAPRO,,Medical History/Concurrent Conditions: Blood pressure high; Fatty liver; High cholesterol; Overweight; Penicillin allergy (Allergies to medications: Penicillin); Type 2 diabetes mellitus,,,"['Dizziness', 'Eyelid irritation', 'Glossodynia', 'Malaise', 'Palpitations', 'Presyncope', 'Skin burning sensation', 'Vision blurred']",1,PFIZER\BIONTECH, 1051415,CA,81.0,F,"muscle and joint pain; wanting to faint/dizziness; blurry eyes; sweating; unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side; unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side/she was having pain on her wrist/joint pain; unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side; swelling in her hand and was hardly able to bend her fingers; swelling in her hand and was hardly able to bend her fingers; wrist was swollen; itchiness, numbness and tingling in her fingers on the right side; itchiness, numbness and tingling in her fingers on the right side; itchiness, numbness and tingling in her fingers on the right side; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN5318), via an unspecified route of administration on 06Feb2021 15:00 at single dose at left arm for covid-19 immunisation. Medical history included wrist had arthritis (pain). There were no concomitant medications. Patient height was a little less than 5. She used to be over 5 but she shrunk. Her weight used to be at 226 lbs, it came up to 230. This year (2021) it went up because, its her, she ate too much and she did not obey the rules. Patient received Pfizer vaccine on 06Feb2021 afternoon at 300 pm in her left arm and that night developed itchiness, numbness and tingling in her fingers on the right side. Last night (07Feb2021) she unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side. she also reported swelling in her hand and was hardly able to bend her fingers. She tried to bend her fingers and she can but her wrist was swollen, it was less right now but she still had the pain. She applied muscle relaxant (unclear if topical) and took paracetamol (TYLENOL) and massaged her hand with warm water and then for the second time she used the muscle relaxation. She hadn't taken paracetamol yet she was waiting 4 hours but the pain was still there, it was a little bit less. Not sure if it her arthritis or side effects from vaccine but believes it was from the vaccine. Stated she used to have the same problem with her wrist arthritis (pain). Also reported that she experienced additional side effects on 08Feb2021 which lasted about 5 minutes then went away: blurry eyes; wanting to faint; dizziness, sweating (whole body started to be like sweaty). Asking for information on muscle and joint pain after the vaccine and recommendations on what to do. So far she didn't know what it was, and if it was a side effect of the arthritis, because once in a while that happens but when it happened it went away right away but this time her wrist pain was there still there. Patient sat down and now she was stretching her leg, she sat down on the chair and its gone she had no more problems. Patient said her right hand, she was very slow writing. She said at least she can write her hand was going back to a routine but she was in a lot of pain. Outcome of event wanting to faint/dizziness, blurry eyes, sweating was recovered on 08Feb2021, and outcome of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/06/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Pain; Peripheral arthritis,,,"['Arthralgia', 'Body height', 'Dizziness', 'Hyperhidrosis', 'Hypoaesthesia', 'Insomnia', 'Joint swelling', 'Musculoskeletal stiffness', 'Myalgia', 'Pain in extremity', 'Paraesthesia', 'Peripheral swelling', 'Pruritus', 'Vision blurred', 'Weight']",1,PFIZER\BIONTECH, 1051417,CA,83.0,F,"She thought she was going to pass out; felt like she was going to faint; chin felt funny; face was red; face was burning; This is a spontaneous report from a contactable consumer(patient). An 83-year-old female patient received first dose of BNT162B2(Covid-19 vaccine, lot number EL8982), via an unspecified route of administration on 27Jan2021 10:00 at single dose, left arm for protection from virus, vitamin D(lot number 15070802 with expiration date Jun2023, Non-Pfizer product, manufacturer: 21st Century), orally from 2019 and ongoing at 2000 iU, daily, (25 mcg/1000 IU, takes 2 by mouth daily) for bones, vitamin b complex (B COMPLEX, lot number 14704704 with expiration date Apr2023, Non-Pfizer product, manufacturer: 21st Century), orally from 2019 and ongoing at unknown dose, daily, (2 by mouth daily) for energy, digoxin(Non- Pfizer product), orally from Jun2019 and ongoing at 0.125 mg, daily to slow the heartbeat, rosuvastatin(Non- Pfizer product), orally from 2019 and ongoing at 20 mg, daily to lower cholesterol. Medical history included high blood pressure, blood thinner, low thyroid. Concomitant medication included hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ) from 2019 and ongoing for high blood pressure, rivaroxaban (XARELTO) from Nov2020 and ongoing as blood thinner, levothyroxine from an unknown date and from Nov2020 and ongoing for low thyroid(had been taking for 25 years or more). History of all previous immunization with the Pfizer vaccine considered as suspect reported as None. Prior Vaccinations (within 4 weeks) reported as None. The patient experienced felt like she was going to faint on 30Jan2021 with outcome of recovered on 30Jan2021, chin felt funny on 30Jan2021 with outcome of recovered 30Jan2021, face was red on 30Jan2021 with outcome of unknown, face was burning on 30Jan2021 with outcome of recovered on 30Jan2021. Caller was asking if she should get the second shot. She went to her doctor and was told it was ok if she got the second shot. The doctor said it was too far between the shot and the reactions for it to be the shot. She received the vaccine on 27Jan2021. On Saturday morning she took Vitamin D, B complex, Digoxin and Rosuvastatin. Twenty minutes later her chin felt funny. Her face was red and burning. She felt like she was going to faint. She got some ice and washed her face. She took 2 baby aspirin. She asked her doctor if she was allergic to the vaccine. Her doctor said the time between getting the vaccine and the events were too far between. She thought she was going to pass out. She felt better after washing her face with ice. She was her face for 30-45 minutes with ice water. She took apixaban (ELIQUIS) before and her chin felt funny. She added that her blood pressure went up and she had trembles. She felt dizzy. Clarified that she felt that way prior to taking the vaccine. At first she didn't think to take her blood pressure. When she took it the reading was 165/79. At 3:00 pm the reading was 162/79. At 6:00 pm the reading was down to 150/79. The trembles started two hours after she took her medications. When providing product details she stated she took two Vitamin D. The label indicated to take one. When asking for indication caller asked what does Vitamin D do? She was able to answer herself. Product is filled in a pharmacy bottle and does not include NDC, Lot or expiry. Prior to taking rivaroxaban (XARELTO), she was taking apixaban (ELIQUIS) 5 mg twice daily. Lot: ABL8694A, Expiry: Dec2022, It came from another country. She was sure she was allergic to it because she had a rash. That was when she was switched to rivaroxaban. She was taking levothyroxine 100 mcg until she turned 82. In Jan2021, the dose was changed to 112 mcg daily. Her last thyroid level was high on the test with a result of 7.46. The dose was changed to 112 mcg daily. Initially caller gave consent to contact her physician. She changed her mind stating she didn't want her doctor to think she was going over her head. She was worried and frightened at the time because something happened to her. She can't remember if her face was swollen. She drank some ice cold water and took two baby aspirins. She knew she needed to flush her system. She just wanted to make she was safe in getting the shot. Her doctor told her to take diphenhydramine hydrochloride (BENADRYL) if she ever felt that way. She felt fine after getting the shot and the few days after getting it. She wanted to get the shot. Events resulted in physician office visit. The action taken in response to the events for vitamin D, vitamin b complex, digoxin, rosuvastatin was dose not changed. The outcome of event ""She thought she was going to pass out"" was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,06/01/2019,01/30/2021,609.0,UNK,TRIAMTERENE HCTZ; XARELTO; LEVOTHYROXINE; DIGOXIN; ROSUVASTATIN; B COMPLEX [VITAMIN B COMPLEX]; VITAMIN D [VITAMIN D NOS],,Medical History/Concurrent Conditions: Blood disorder; Blood pressure high; Thyroid function decreased,,,"['Blood pressure measurement', 'Burning sensation', 'Dizziness', 'Erythema', 'Jaw disorder', 'Presyncope', 'Thyroid function test']",1,PFIZER\BIONTECH, 1051418,,,M,"a mild kidney infection; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as 70; unit unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 08Feb2021 at SINGLE DOSE for covid-19 imunisation. Patient's medical history and concomitant medications were not reported. It was reported that patient received first dose of the Covid vaccine yesterday (08Feb2021). Patient reported that it appears he has a mild kidney infection on an unspecified date in which his urologist has prescribed ciprofloxacin to take. Patient asked if an antibiotic will interfere with his vaccination. Outcome of the event was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,,,UNK,,,,,,['Kidney infection'],1,PFIZER\BIONTECH, 1051419,IN,,M,"diverticulitis, his condition flares up every once in a while; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Feb2021 at a single dose for COVID-19 immunization. Medical history included diverticulitis. Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on an unspecified date for COVID-19 immunization. The patient was concerned about efficiency of the vaccine. He received a second dose of bnt162b2 yesterday morning and today (09Feb2021) he was experiencing bout of diverticulitis and his doctor has given him couple of antibiotics, one of them being Cipro and the other was Flagyl to treat diverticulitis and he was just concerned given he just received a vaccine if those antibiotics would affect the efficiency of the vaccine. He was concerned because he has been given antibiotics by his doctor for when his condition flares up every once in a while. The doctor gave him Cipro and Flagyl. He was wondering if he takes these, if it will have any impact on the efficacy of the vaccine. He thinks the flare up was coming on before the shot so he didn't want to do a report. The outcome of the event was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/09/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Diverticulitis,,,['Diverticulitis'],2,PFIZER\BIONTECH, 1051420,NC,50.0,F,"Headache; Temperature 99 - 101 F; tiredness; higher blood pressure then usual (140 X 82); administration date=02Feb2021, dose number=2/administration date=20Jan2021, dose number=1; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) on her right arm, via an unspecified route of administration on 02Feb2021 10:30 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 (first dose) for covid-19 immunization. The patient experienced Headache, Temperature 99 - 101 F, tiredness, higher blood pressure than usual (140/82); all on 03Feb2021 06:00 AM. Patient received Ibuprofen 200 as treatment for the events. The outcome of the events was recovered on unspecified dates.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,WRK,,,,,,"['Blood pressure measurement', 'Body temperature', 'Fatigue', 'Headache', 'Hypertension', 'Inappropriate schedule of product administration', 'Pyrexia']",2,PFIZER\BIONTECH, 1051421,,,F,"green bile coming out of my behind/ having little green bowel; Bowel like a diarrhea, or bowel movement; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program Pfizer First Connect. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated ""I am experiencing green bile coming out of my behind. Can your covid-19 vaccine cause that?"" It was clarified as seeing green bile after going to the bathroom and having a stool. It was stated that Sunday she started having little green bowel until today; bowel like a diarrhea or bowel movement. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Diarrhoea', 'Faeces discoloured']",UNK,PFIZER\BIONTECH, 1051423,,,M,"viral meningitis, losing function in his legs; viral meningitis, losing function in his legs; headache; dizziness; fatigue; nausea; weak; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient kept having very very bad headaches, dizziness, fatigue, nausea, for several days about a whole week and experienced ""viral meningitis, losing function in his legs and he's still weak and having issues"". The outcome of the events was unknown. information on the LOT/Batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Asthenia', 'Dizziness', 'Fatigue', 'Headache', 'Meningitis viral', 'Musculoskeletal disorder', 'Nausea']",1,PFIZER\BIONTECH, 1051424,IL,28.0,F,"Cough; Fever; Chills; Body aches; This is a spontaneous report from a contactable consumer. A 28-year-old female patient receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration at left arm from an unspecified date at a single dose for COVID-19 immunisation. The patient had no medical history. The patient is not pregnant. There were no concomitant medications. On an unspecified date, after first vaccine for two weeks, the patient had a cough, couple days of fever, chills and body aches. The outcome of the events was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Cough', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 1051425,PA,47.0,F,"Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelling and pain of injection site; Swelling and pain of injection site; Fever; Chills; 3 by 5 inch red circle and swelling around injection site/arm turned red; This is a spontaneous report from a contactable other healthcare professional (medical receptionist -patient). A 47-years-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EL3246, expiration date unknown), via an unspecified route of administration on the left arm on 20Jan2021 at 17:30 at the age of 47 years old at a single dose for COVID- 19 immunisation in the hospital. Medical history included mitral valve prolapse, gallstones , hypertension and crab allergy. Concomitant medications included lisinopril and hydrochlorothiazide. The patient did not receive vaccines in four weeks. On 28Jan2021 at 07:00 AM, the patient had a little bit of arm soreness initially. The patient experienced swollen lymph nodes under arm, swelling and pain of injection site, fever and chills. On the 9th day after vaccine (29Jan2021), patient had a 3 by 5 inch red circle and swelling around injection site. It was also reported that the arm and lymph nodes swelled. The patient had fever and chills. Then her arm turned red. As of 05Feb2021, the swollen mark which is about 5x4 inches is swelling again. The patient's next dose is scheduled for 10Feb2021. She is really concerned about getting the second dose. The events were assessed as non-serious by the reporter. It was unknown if the patient received a treatment in response to the events. The patient was not diagnosed with COVID-19 prior t vaccination and was not tested for COVID-19 post vaccination. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/28/2021,8.0,PVT,LISINOPRIL; HYDROCHLOROTHIAZIDE,,Medical History/Concurrent Conditions: Food allergy; Gallstones; Hypertension; Mitral valve prolapse,,,"['Chills', 'Lymphadenopathy', 'Pain in extremity', 'Pyrexia', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 1051426,FL,42.0,F,"anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue tingled; sore/scratchy throat; metal taste in mouth; shakiness (like internal vibration); This is a spontaneous report from a contactable other hcp. A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 03Feb2021 08:00 for covid-19 immunisation. Medical history included depression, anxiety, drug hypersensitivity to codeine, sulfa meds, influenza vaccine, food allergy to quinoa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), probiotics. The patient experienced anaphylactic reaction on 03Feb2021 08:30, flush face with itching on 03Feb2021 08:30, throat became itchy on 03Feb2021 08:30, tongue tingled on 03Feb2021 08:30, sore/scratchy throat on 03Feb2021 08:30, metal taste in mouth on 03Feb2021 08:30, shakiness (like internal vibration) on 03Feb2021 08:30. Patient went to Emergency Room and was treated with Benadryl, Pepcid C, Decadron, Epi. The outcome of the events was not recovered. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information, a possible contribution of the drug to the event anaphylactic reaction cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/03/2021,0.0,WRK,WELLBUTRIN; D3; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL],,Medical History/Concurrent Conditions: Anxiety; Depression; Drug hypersensitivity (sulfa meds); Food allergy (to quinoa),,,"['Anaphylactic reaction', 'Dysgeusia', 'Flushing', 'Oropharyngeal pain', 'Paraesthesia oral', 'Pruritus', 'Throat irritation', 'Tremor']",1,PFIZER\BIONTECH, 1051427,,,U,"an anaphylactic reaction; This is a spontaneous report from a Pfizer sponsored program Pfizer RxPathways from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Covid vaccine and had an anaphylactic reaction. The patient had an allergic reaction and had to take an ambulance to the hospital. Information on the Lot/Batch Number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,['Anaphylactic reaction'],1,PFIZER\BIONTECH, 1051428,MI,55.0,F,"achiness; low grade fever 100.6; fatigue; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3248), via an unspecified route of administration on the left arm at the age of 55 years, on 09Feb2021 16:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (IBUPROFEN), colecalciferol (VITAMIN D), vitamin c [ascorbic acid] (VITAMIN C) and Multi Vitamin. The patient had the first dose last 20Jan2021. The patient experienced achiness, low grade fever 100.6 and fatigue on 10Feb2021. The patient underwent lab tests and procedures which included body temperature: 100.6 on 10Feb2021. No treatment was received for the adverse events. The outcome of events was recovered on unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/10/2021,1.0,WRK,IBUPROFEN; VITAMIN D; VITAMIN C,,Medical History/Concurrent Conditions: Asthma,,,"['Body temperature', 'Fatigue', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1051429,OH,,U,"bad nose bleed/It's bleeding in the back of my nose; the clots are so big that I gag when I expel them; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 on 01Feb2021 at single dose for covid-19 immunization. Medical history was not reported. Concomitant medications included warfarin sodium (COUMADIN). On 02Feb2021, patient had a bad nose bleed which patient stopped. On 03Feb2021 paitent was ok and on 04Feb2021 patient got a nose bleed that patient could not stop and still have to be careful and not do anything as it starts all over again. It's bleeding in the back of nose also and the clots are so big that patient gag when patient expel them. The outcome of the event was not recovered. Information on batch/lot number was requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,UNK,COUMADIN,,,,,"['Epistaxis', 'Retching']",UNK,PFIZER\BIONTECH, 1051430,NJ,56.0,F,"sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; scratchy throat on eating red meat, milk, or cheese; muscle and joint pain; earache; pain was all over; muscle and joint pain; headache; exhaustion; pain at injection site; slight fever; mild nausea; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264), on right arm via an unknown route of administration on 03Feb2021 13:45 for COVID-19 immunization. Medical history included VonWillebrand's and history of lyme disease. The patient had allergy to peanut and allergy to latex. Concomitant medications included unspecified vitamin supplements. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302) on Left arm, on 13Jan2021 13:30 for COVID-19 immunization. Patient stated, ""After first shot in left arm, only on her left side she had: Muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered. Second shot in right arm: Same as above (muscle and joint pain, earache, headache, exhaustion, and pain at injection site), although no eye drainage and pain was all over with slight fever, mild nausea in Feb2021. Lasted from 12 hours to 36 hours after the test. Arm remained sore longer, but not problematic. Bizarre possible response: 6 days after second shot on 09Feb2021 17:30, the patient experienced sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes, scratchy throat on eating red meat, milk, or cheese. Patient did not need epi-pen but needed double dose of benadryl. Events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Benadryl and epi-pen on hand was received as treatment for events. The events were assessed as non-serious by the reporter. Outcome of events muscle and joint pain, earache, headache, exhaustion, pain at injection site, pain was all over, slight fever, mild nausea was recovered in Feb2021, whereas outcome for other events was reported as unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/01/2021,,PVT,,,Medical History/Concurrent Conditions: Latex allergy; Lyme disease; Peanut allergy; Von Willebrand's disease,,,"['Arthralgia', 'Ear pain', 'Eye swelling', 'Fatigue', 'Headache', 'Hypersensitivity', 'Laboratory test', 'Myalgia', 'Nasal oedema', 'Nausea', 'Pain', 'Pyrexia', 'Swelling', 'Throat irritation', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1051431,AL,,F,"pneumonia; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Three weeks after the first vaccination, the patient experienced pneumonia on an unspecified date. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,,,UNK,,,,,,['Pneumonia'],1,PFIZER\BIONTECH, 1051432,NC,30.0,F,"Headache; Tiredness; Fever; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 09Feb2021 at 17:00 at a single dose on the right arm for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 09Feb2021 at 19:00, the patient experienced headache, tiredness and fever. Patient received Acetaminophen as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events were recovered on an unspecified date. The events were considered non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Fatigue', 'Headache', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1051433,NY,64.0,M,"Slight increased heartbeat for about one hour; Headache for the rest of the day; This is a spontaneous report from a contactable consumer (patient) reported that a 64-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: En-6201, expiry date unknown) in the hopsital via an unspecified route of administration on 11Feb2021 at 12:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced slight increased heartbeat for about one hour at 12:30 then a headache for the rest of the day both on 11Feb2021. The outcome of the event slight increased heartbeat for about one hour was recovered on 11Feb2021 at 13:30 and the outcome of the event headache for the rest of the day was recovered on Feb2021. The patient did not receive treatment for the events. The events was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,PVT,,,,,,"['Headache', 'Heart rate', 'Heart rate increased']",1,PFIZER\BIONTECH, 1051434,,35.0,F,"sore arm and headache overnight; sore arm and headache overnight; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration (right arm), on 11Feb2021 10:00, at single dose, for covid-19 immunization. Medical history included celiac disease. Concomitant medication included bupropion. The patient experienced sore arm and headache overnight on 11Feb2021 18:00. The patient recovered from the events on 12Feb2021. The patient took ibuprofen (ADVIL) as treatment for the events (self-prescribed). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,UNK,BUPROPION,,Medical History/Concurrent Conditions: Celiac disease,,,"['Headache', 'Pain in extremity']",1,PFIZER\BIONTECH, 1051435,CO,70.0,F,"Fatigue; Body Aches/Soreness; Chills; Swollen and Sore Tongue; Swollen and Sore Tongue; Diarrhea; Loss of Appetite; Throat swelling; Headache; Malaise; Shortness of Breath; Thick Mucus in Nose & Throat; Thick Mucus in Nose and Throat; Horseness and Sore Throat; Horseness and Sore Throat; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on right arm on31Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included autoimmune, tachycardia, acid reflux, penicillin allergy, walnuts allergy. Concomitant medication included estradiol and levothyroxine. The patient previously took lanolin and erythromycin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 patient experienced fatigue, body aches/ soreness, chills, swollen and sore tongue, diarrhea, loss of appetite, throat swelling requiring 2 visits to the ER (emergency room). Culminating in Steroid injection and oral Prednisone. Headache, malaise, shortness of breath, thick mucus in nose and throat, hoarseness and sore throat. The adverse events result in Doctor or other healthcare professional office/ clinic visit and Emergency room/department or urgent care. The seriousness of the events was assessed as non-serious by the reporter. Therapeutic measurements were received for the events with steroid injection at the ER and oral Prednisone. The outcome of the events was reported as not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,02/05/2021,5.0,UNK,ESTRADIOL; LEVOTHYROXINE,,Medical History/Concurrent Conditions: Acid reflux (oesophageal); Autoimmune disorder; Food allergy; Penicillin allergy; Tachycardia,,,"['Chills', 'Decreased appetite', 'Diarrhoea', 'Dysphonia', 'Dyspnoea', 'Fatigue', 'Glossodynia', 'Headache', 'Increased upper airway secretion', 'Increased viscosity of upper respiratory secretion', 'Malaise', 'Oropharyngeal pain', 'Pain', 'Pharyngeal swelling', 'Swollen tongue']",1,PFIZER\BIONTECH, 1051437,TX,58.0,F,"lips swelling; This is a spontaneous report from a contactable consumer reported for herself. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot number #EL9267on 14Feb2021 09:00 AM (at 58 year old) at single dose via unspecified route at the left arm, for COVID-19 immunization. Medical history included Anaphylactic reaction to the Capsaicin Family, thyroid and High Blood Pressure. Concomitant medications included levothyroxine sodium (SYNTHROID), lisinopril, verapamil and loratadine (CLARITIN). The patient was not pregnant. No COVID prior vaccination. The patient had not been tested for COVID since the vaccination. On 14Feb2021 09:15 AM the patient experienced lips swelling. The outcome of the event was unknown. The patient visited Emergency room for the event and treatment was received, steroid shot and prednisone for 5 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/14/2021,02/14/2021,0.0,UNK,SYNTHROID; LISINOPRIL; VERAPAMIL; CLARITIN,,Medical History/Concurrent Conditions: Anaphylactic reaction (Anaphalic to the Capsacian Family); Blood pressure high; Thyroid disorder,,,['Lip swelling'],1,PFIZER\BIONTECH, 1051438,OK,72.0,F,"feeling weak; shaky; fever, 100.4; her eyes start feeling funny and burning when she has a fever; her eyes start feeling funny and burning when she has a fever; arm was a little sore; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients. This is the first of 2 reports. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration at the right upper arm close to the shoulder on 02Feb2021 07:30 at single dose as she doesn't want to get COVID again or give COVID to anyone else. Medical history included metabolic syndrome from 1994 and ongoing, it all started when she was 46 and it runs in her family and it was a genetic thing; ongoing diabetes mellitus, was diagnosed when she was 65, so 7 years ago; she had COVID in Nov2020 but it was just a very mild case and she just had a cough; and cardio artery problems. She takes a lot of medications and she has metabolic syndrome which includes cardio artery problems and diabetes, but she has taken all of those medications for a long time. The patient says she was calling to report a couple little concerns she has. She received her shot on Tuesday, 02Feb2021 at about 7:30 in morning and her arm started at about 2 to 3 in the afternoon and she noticed it was getting sore, but it was no big deal, she did not think anything of it, and on the second day she thought that was it and she was over it on 03Feb2021. She states her husband also mentioned that he had soreness in his arm after his vaccination. She says at three in the afternoon on 03Feb2021, she started feeling weak and shaky, but she didn't think much of that. She says this began around 3 to 4 when yesterday afternoon, 03Feb2021, she had a fever. She says she took her temperature and it was 100.4 and that all kind of was gone by the evening but when she woke up this morning, she was weak and shaky again. Today she got up and was weak and shaky and it never left, she was still weak and shaky. The patient mentions that she was diabetic so she can get weak and shaky when she needs to eat something, but she had just eaten, and she ate yesterday so she doesn't think it was caused by that. The patient says she thinks we should know that she was diabetic. She says then she could tell that she had a fever, so she took her temperature and it was 100.4 which for her was high. She states she didn't even have a fever when she had COVID. The fever began yesterday afternoon (03Feb2021). She says her eyes start feeling funny and burning when she has a fever and they felt that way so that's why she took her temperature. This was the highest it has been in years. She says last night she took her temperature again and the fever had gone away in 30 to 40 minutes, so she thought it was over. She took her temperature again before she called this morning, 04Feb2021 and it was 99.2, which was still a little hot for her. She says for her that's a fever. She was 96 and 97 usually. The patient says she still feels like she has a little fever. She was not someone who usually has a fever and it can be just a little bit of a fever for instance like this morning when she was 99.2. Her eyes were still feeling funny and burning this morning and that was why she took her temperature this morning. The outcome of the event arm was a little sore was recovered on 03Feb2021; feeling weak and shaky was not recovered; fever and her eyes start feeling funny and burning when she has a fever was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162089 Same reporter/drug, similar event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,PVT,,"Diabetes (Caller says she was diagnosed when she was 65, so 7 years ago.); Metabolic syndrome (She says it runs in her family and it is a genetic thing.)",Medical History/Concurrent Conditions: Coronary artery disorder; Cough; COVID-19,,,"['Asthenia', 'Body temperature', 'Eye irritation', 'Feeling abnormal', 'Pyrexia', 'Tremor', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1051443,OK,,M,"soreness in his arm after his vaccination; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for 2 patients. This is the second of two reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's wife received the shot and she noticed her arm was getting sore. The wife stated that the patient (her husband) also mentioned that he had soreness in his arm after his vaccination, but she does not think she wants to complete a report for her husband who had a sore arm from the COVID vaccination. She says he was not here right now, and he doesn't have anything wrong with him. She doesn't really think that he has anything else and she doesn't think it was that sore, he just commented that night that it was a little sore. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021156186 Same reporter/drug, similar event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination site pain'],UNK,PFIZER\BIONTECH, 1051444,MI,43.0,F,"Injection site bruising and pain; Injection site bruising and pain; Nausea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), via an unspecified route of administration on 15Jan2021 08:00 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin. The patient's concomitant medications were not reported. Patient was not pregnant. The patient experienced nausea, injection site bruising and pain at 15Jan2021 09:00AM. No prior covid vaccination. No Covid tested post vaccination. Facility type vaccine was Workplace Clinic. No other vaccine in four weeks. Events resulted in none of the above. Patient was recovered in 2021. No treatment received for adverse events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021182443 same reporter, same patient, same product (different dose), different events",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Nausea', 'Vaccination site bruising', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1051445,,61.0,F,"chest x-ray shows numerous bilateral patchy opacities; catastrophic brain bleed; Brainstem reflexes were lost; Patient died; shortness of breath; nausea; diarrhea; worsening shortness of breath/numerous bilateral patchy opacities; immunosuppressed status; This is a spontaneous report from a contactable pharmacist and a contactable other health professional. A 61-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular at arm right on 28Jan2021 (at the age of 61 years) at single dose for COVID-19 immunization. The patient medical history included bilateral lung transplant on 23Jun2017, lymphangioleiomyomatosis, hepatocellular carcinoma, antibody mediated rejection of lung transplant , bronchiolitis obliterans syndrome, grade 0P, major depressive disorder, RLS (restless legs syndrome), chronic insomnia, long term current use of systemic steroids OSA (obstructive sleep apnea), iron deficiency anemia, bilateral sciatica, hoarseness of voice, memory change, laryngeal stridor, pure hypercholesterolemia senile nuclear cataract, bilateral myopia of both eyes, osteoporosis without current pathological fracture, alopecia, immunosuppressed status, all from an unknown date and unknown if ongoing. Concomitant medication included acyclovir (formulation: capsule, strength: 200 mg) oral at 200 mg twice daily, salbutamol (ALBUTEROL HFA) as needed (MCG/ACT inhaler take 2 puffs by inhalation every 4 hours as needed) for wheezing (shortness of breath), atorvastatin (LIPITOR, formulation: tablet) oral at 80 mg once a day, azithromycin (ZITHROMAX, formulation: tablet)oral at 250 mg (every Monday, Wednesday, Friday), bupropion hydrochloride (WELLBUTRIN XL, formulation: tablet, strength: 150 mg) oral at 150 mg once a day, calcium citrate/cholecalciferol (CALCIUM + VITAMIN D, formulation: tablet) oral at 2 dose form once a day (every morning), everolimus (ZORTRESS, formulation: tablet, strength: 1 mg) oral at 2 mg twice a day, fluticasone propionate/salmeterol xinafoate (ADVAIR, strength: 500 ug/ 20 ug) twice daily (1 puff by inhalation), gabapentin (NEURONTIN, formulation: capsule, strength:100 mg) oral at 300 mg daily (by mouth nightly), loratadine (CLARITIN, formulation: tablet, strength: 10 mg) oral at 10 mg as needed, metoprolol tartrate (LOPRESSOR, formulation: tablet, strength: 25 mg)oral at 50 mg twice daily, minoxidil (ROGAN, strength: 5%) topical apply 1 cap full every other day to affected area on scalp for alopecia, ondansetron (ZOFRAN, formulation: tablet, strength: 4 mg) oral at 4 mg as needed for nausea, pantoprazole sodium sesquihydrate (PROTONIX, formulation: tablet, strength: 40 mg) oral at 40 mg once a day, prednisone (DELTASONE, formulation: tablet, strength: 5 mg) oral at 5 mg daily (every morning), sertraline hydrochloride (ZOLOFT, formulation: tablet, strength: 100 mg) oral at 100 mg twice a day (every morning), sulfamethoxazole/trimethoprim (BACTRIM) 400-80 mg per tablet (1 tablet by mouth every Monday, Wednesday, Friday), tacrolimus (formulation: capsule) at 3 mg daily (2 mg every morning and 1 mg at night), salbutamol sulfate (PROVENTIL HFA) as needed for wheezing (shortness of breath), salbutamol sulfate (VENTOLIN HFA) as needed for wheezing (shortness of breath) , salbutamol sulfate (PROAIR HFA) as needed for wheezing (shortness of breath), ascorbic acid/ferrous fumarate/folic acid/ retinol (PRENATAL, formulation: tablet) oral daily. The patient previously took NSAIDs and voriconazole and experienced drug allergies. It was reported that the patient presented to emergency department (ED) on 04Feb2021 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine. Full viral panel including COVID-19 was not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 08Feb2021 and then VV ECMO cannulation on 13Feb2021. Acute pupil exam changes in the early am hours of 15Feb2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. The events were all serious. The patient outcome of the events was fatal. The patient died on 15Feb2021. It was not reported if an autopsy was performed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. However, the reported event may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Chest x-ray shows numerous bilateral patchy opacities; Catastrophic brain bleed; Brainstem reflexes were lost; shortness of breath; nausea; Diarrhea; Worsening shortness of breath/numerous bilateral patchy opacities",Yes,02/15/2021,Yes,Yes,11.0,Not Reported,N,01/28/2021,01/28/2021,0.0,UNK,ACYCLOVIR [ACICLOVIR]; ALBUTEROL HFA; LIPITOR [ATORVASTATIN]; ZITHROMAX; WELLBUTRIN XL; CALCIUM + VITAMIN D [CALCIUM CITRATE;COLECALCIFEROL]; ZORTRESS; ADVAIR; NEURONTIN; CLARITIN [LORATADINE]; LOPRESSOR; ROGAN [MINOXIDIL]; ZOFRAN [ONDANSET,,Medical History/Concurrent Conditions: Alopecia; Antibody-mediated rejection; Bronchiolitis obliterans syndrome (grade 0P); Chronic insomnia; Hepatocellular carcinoma; Hoarseness of voice; Immunosuppression; Iron deficiency anemia; Laryngomalacia; Lung transplant; Lymphangioleiomyomatosis; Major depressive disorder; Memory impairment; Myopia; Nuclear cataract; Obstructive sleep apnea syndrome; Osteoporosis; Pure hypercholesterolemia; Restless legs syndrome; Sciatica,,,"['Blood culture', 'Brain stem haemorrhage', 'Brain stem syndrome', 'Chest X-ray', 'Chest X-ray abnormal', 'Condition aggravated', 'Culture', 'Death', 'Diarrhoea', 'Dyspnoea', 'Nausea', 'Product use issue', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1051446,MA,79.0,F,"grade 2 allergic reaction; short of breathe; flushed; she was an oncology patient with large granular lymphocytic leukemia and received BNT162B2; she was an oncology patient with large granular lymphocytic leukemia and received BNT162B2; This is a spontaneous report from a contactable other healthcare professional. A 79-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9262, NDC number of COVID Vaccine: 59267-1000-1; Expiry Date of COVID Vaccine: 31May2021), intramuscularly at Left Deltoid on 08Feb2021 10:30 (either 10:30AM or within that hour or prior) at single dose for COVID-19 immunization. Medical history included anxiety, panic disorder, asthma, obstructive sleep apnea, additional Information for Other Conditions: She was oxygen Dependent, coeliac disease, allergy, Additional Information for Other Conditions: She had Medication, Environmental, and Food Allergies, central neuro hearing loss, vertigo, Allergic rhinitis, gastrooesophageal reflux disease (GERD), Additional Information for Other Conditions: Esophageal Reflux, osteopenia, impaired glucose tolerance, hypothyroidism, claustrophobia, rheumatoid arthritis (she had arthritis for which she took Orencia for), history of coronary heart disease, diabetes, she would be a targeting patient, as she was an oncology patient with large granular lymphocytic leukemia she met criteria for the pandemic, as well as they put down that she was due for immunization. She had anaphylaxis to bees. With adhesive tapes she got dermatitis. With shellfish she got hives. She had a gluten sensitivity and with mango her mouth gets fuzzy. Family Medical History Relevant to AE(s): her sisters had a few cancer. There were no concomitant medications. The patient previously received levofloxacin she had hives, with quinolones drug class she had hives, with thiopental she had hives and needed IV Decadron for it, with sertraline she has syncope, with Revatio she had an adverse event of joint and muscle pain, with ciprofloxacin she had tachycardia, with Enbrel it caused a drug induced pulmonary fibrosis granulomatosis, with Montelukast she had a headache and muscle pain, nitrofurantoin she had headache, with Symbicort it gave her hoarseness, she took Orencia for arthritis, she got the flu Vaccine in Sep2020. That was most recent. The patient had a grade 2 allergic reaction on 08Feb2021. The patient was watched after administering the vaccine on 08Feb2021 as she had background of multiple allergies and asthma. She was watched for 30 minutes in the oncology unit infusion suite. The reaction happened within 5 minutes of administration. Seriousness Criteria: Caller explained that this reaction was mild to moderate, there was a grade to intervene but at no point was she unstable, she did have a significant anxiety disorder, and so she was nervous about getting the vaccine. She was short of breathe, odd and flushed. She was physically stable, her vitals were stable and there was no angioedema. Reporter seriousness for grade 2 allergic reaction: Medically significant. The patient recovered, as a treatment they gave her IV Benadryl 50mg and IV fluids, she also had her own albuterol inhaler. In the pandemic, they are not doing nebulizers. The outcome of events allergic reaction, shortness of breath and flushed was recovered on 08Feb2021. Relatedness of drug to reaction(s)/event(s). Reaction assessed: Grade 2 allergic reaction; Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Related. Causality: reporter stated that she did think the patient's base line anxiety played into the reaction she experienced, the reaction was aggravated by it.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of grade 2 allergic reaction, short of breathe and flushed due to temporal relationship and current known drug safety profile. The patient's underlying allergic physique also predisposed the patient to developing the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,UNK,,,"Medical History/Concurrent Conditions: Adhesive tape allergy; Allergic rhinitis (Verbatim: Allergic rhinitis); Allergic urticaria; Allergy (Additional Information for Other Conditions: She has Medication, Environmental, and Food Allergies.); Anaphylactic reaction; Anxiety (Verbatim: Anxiety); Asthma (Verbatim: Asthma); Cancer (Family Medical History Relevant to AE(s): her sisters had a few cancer); Celiac disease (Verbatim: Celiac disease); Claustrophobia (Verbatim: Claustrophobia); Coronary heart disease; Diabetes; Drug allergy; Environmental allergy; Food allergy; GERD (Additional Information for Other Conditions: Esophageal Reflux); Glucose tolerance impaired (Verbatim: Impaired Glucose Tolerance); Gluten sensitivity (with mango her mouth gets fuzzy); Hypothyroidism (Verbatim: Hypothyroidism); Leukemia lymphocytic; Obstructive sleep apnea syndrome (Additional Information for Other Conditions: She is oxygen Dependent.); Osteopenia (Verbatim: Osteopenia); Panic disorder (Verbatim: Panic disorder); Rheumatoid arthritis (she has arthritis for which she takes Orencia for); Sensorineural hearing loss (Verbatim: Central Neuro hearing loss); Vertigo (Verbatim: Vertigo)",,,"['Dyspnoea', 'Flushing', 'General physical condition', 'Hypersensitivity', 'Off label use', 'Product use issue']",1,PFIZER\BIONTECH,OT 1051448,IL,60.0,M,"angioedema - swelling of upper lip; This is a spontaneous report from a contactable physician. A 60-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via intramuscular on 03Feb2021 12:00 at single dose in left arm for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM II), hypertension (HTN). No covid prior vaccination and no covid tested post vaccination. No known allergies. Concomitant medication included lisinopril. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via intramuscular on 14Jan2021 12:00 at single dose in left arm for COVID-19 immunization. No other vaccine in four weeks. The patient experienced angioedema - swelling of upper lip on 05Feb2021 08:00. The event was resulted in doctor or other healthcare professional office/clinic visit. Treatment included prednisone/diphenhydramine/Pepcid. The outcome of the event was recovered in Feb2021.; Sender's Comments: A causal relationship between BNT162B2 and the event angioedema cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/05/2021,2.0,PVT,LISINOPRIL,,Medical History/Concurrent Conditions: Hypertension; Type 2 diabetes mellitus,,,['Angioedema'],2,PFIZER\BIONTECH,OT 1051449,IL,33.0,F,"9-10min after getting the shot, my lungs felt like I was running a marathon; chest pain; my ears and face flushed red & hot; my ears and face flushed red & hot; coughing; choking; couldn't breathe; My throat was swelling up so fast and filling with a thick mucous; My throat was swelling up so fast and filling with a thick mucous; she was not coherent enough to remember it; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 17Feb2021 15:00 for Covid-19 immunisation, administered at hospital. Medical history included asthma, gastrooesophageal reflux disease (GERD), endometriosis, adenomyosis, polycystic ovaries (PCOS), anaphylactic reaction Known allergies: fried chicken/fast food unknown preservative (anaphylactic). Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included: levonorgestrel (MIRENA), omeprazole (OMEPRAZOLE), paracetamol (TYLENOL). No other vaccine in 4 weeks. The patient previously took cyclobenzaprine and experienced dust allergy, metronidazole and experienced drug hypersensitivity, cephalexin and experienced drug hypersensitivity, tramadol and experienced anaphylactic reaction. On 17Feb2021 03:15 PM, 9-10 min after getting the shot, her lungs felt like she was running a marathon. She told the observer and before she finished describing her chest pain, her ears and face flushed red & hot. She called for a stretcher and she started coughing. They got her on a stretcher & ran her to the ER down the hallway. She was coughing and choking and couldn't breathe. Her throat was swelling up so fast and filling with a thick mucous. Patient received treatment with an epinephrine shot, solumedrol shot, Benadryl shot & started an iv steroid that started with a V sound (between choking/epinephrine/Benadryl, she was not coherent enough to remember it). Within a few minutes her coughing subsided and she was able to breathe normally. She received an albuterol treatment at that point. She was kept under observation for 5 hours. At about the 4 hour mark she had another albuterol treatment. She has continued albuterol treatments every 4 hrs. Oral Prednisone, oral Benadryl. It's hills immediately after meds, valleys between. Patient was not tested for covid post vaccination. AEs resulted in: doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event. Reactions were ongoing. The outcome of events was recovering.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,PVT,MIRENA; OMEPRAZOLE; TYLENOL,,Medical History/Concurrent Conditions: Adenomyosis; Allergy to chemicals (Known allergies: Nickel); Anaphylactic reaction to food (Known allergies: fried chicken/fast food unknown preservative (anaphylactic)); Asthma; Endometriosis; GERD; House dust mite allergy (Known allergies: dust mites); Polycystic ovary (PCOS),,,"['Chest pain', 'Choking', 'Confusional state', 'Cough', 'Dyspnoea', 'Erythema', 'Hot flush', 'Increased viscosity of bronchial secretion', 'Lung disorder', 'Pharyngeal swelling']",1,PFIZER\BIONTECH, 1051450,WI,66.0,M,"has a spot coming on that looks the same and feels the same as the MRSA he had before/red spot/little swollen on the outside/like a pimple; This is a spontaneous report from contactable consumers (patient and patient's wife) reported that a 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular on the left arm on 26Jan2021 16:15 at a single dose for Covid-19 immunization. Medical history included ongoing blood pressure high, rheumatoid arthritis and diabetes; all from an unknown date and were diagnosed many years ago. The patient had MRSA before 12 years ago (2009). Concomitant medications included prednisone. It was reported that 12 years ago, he had MRSA. He thought he has it again. The patient clarified that he had MRSA about 12 years ago and he doesn't know if there was a chance the COVID-19 triggered the MRSA. He was not positive it was even MRSA. He has a spot coming on that he noticed last night (08Feb2021). The spot he has now looks the same and feels the same as the MRSA he had before. However, it's not the in the same area. It's in the same arm he got the shot in, which he doubted it has anything to do with the COVID-19 vaccine. It just looks and feels the same as it did 12 years ago when he had MRSA. The caller explains the spot was about the size of a dime, maybe a little bit smaller. There was a red spot of course. It shows on the outside, it's a little swollen on the outside, but there was a bigger area on the inside. He explained further there was more of it on the inside. The patient's wife told him it looks like a pimple. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,02/08/2021,13.0,UNK,PREDNISONE,Blood pressure high; Diabetes; Rheumatoid arthritis,"Medical History/Concurrent Conditions: Infection MRSA (12 years ago, he had MRSA)",,,['Staphylococcal infection'],1,PFIZER\BIONTECH,OT 1051451,,,F,died 15 min later; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable consumer reported that a female patient (mother) of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided. The reporter stated her mother took the vaccine and died 15 min later. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: died 15 min later,Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],UNK,PFIZER\BIONTECH, 1051452,MI,43.0,F,"Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely a low-grade fever; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3248, vaccine location=Left arm), via an unspecified route of administration on 04Feb2021 08:15 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin. The patient's concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), on 15Jan2021 08:00 AM for covid-19 immunisation and experienced nausea, injection site bruising and pain. Patient was not pregnant. The patient experienced injection site pain, severe headache, dry mouth, mild nausea, general malaise, fatigue, nighttime sweats and likely a low-grade fever all at 05Feb2021 04:00AM. No other vaccine in four weeks. No covid tested post vaccination. Events resulted in none of the above. No treatment received for adverse events. The patient was recovering; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162107 same reporter, same patient, same product (different dose), different events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,WRK,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Dry mouth', 'Fatigue', 'Headache', 'Malaise', 'Nausea', 'Night sweats', 'Pyrexia', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1051453,AZ,56.0,F,"They were kind of itched; I was scratching and it was starts to bleed; They were kind of itched; I was scratching and it was starts to bleed; They were kind of itched; I was scratching and it was starts to bleed; They are scabbed like almost like scars; that scars on my arm; They were burning kind of and they scabbed over; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; This is a spontaneous report from a contactable consumer reported for herself. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), lot number# EL0142 via unspecified route at the arm on 26Jan2021 (at 56 year old) at single dose for COVID-19 immunization. Medical history was not reported, and concomitant medications included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient reported as follows: ""I was scratching and it was starts to bleed ,I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection , they were kind of itched; they are scabbed like almost like scars; that scars on my arm , they were burning kind of and they scabbed over .Then the consumer added: I would say probably came on about I have to guess may be 3 to 5 days after I had the shot and they were kind of the itched and I was scratching and it was starts to bleed that want to I don't know about a week and a few days after I noticed on my arm, also noticed on my back of right trapezius muscle. So on top like on my in my back and behind my neck and it started all of my right side and I was awaken one night because they were burning kind of and they scabbed over so it was just look like scabbed kind of and when I scratch it scab kind of come off and it would bleeding kind of burn. ""they are still there but they are having healed like on my arm have like you can see them, but they are scabbed like almost like scars. That scars on my arm, I can see they are still there, but they are not bleeding anymore."" Regarding treatment she stated, ""I only took Benadryl on one night because night before they woke me up because it was burning. They were hurting when I scratched them."" The patient was recovered from wound bleeding while the outcome of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/01/2021,,UNK,VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE],,,,,"['Erythema', 'Pruritus', 'Rash', 'Scab', 'Scratch', 'Skin burning sensation', 'Vaccination site macule', 'Wound haemorrhage']",1,PFIZER\BIONTECH, 1051454,MN,84.0,F,"She had little reaction like fever; This is a spontaneous report from a contactable consumer (patient's son/daughter) via Pfizer sponsored Program. An 84-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose in Feb2021 (9 days before this report) for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had little reaction like fever in Feb2021 and also went to the hospital. The event was considered life threatening. The outcome of event was unknown. Reporter wanted to know if her reaction was related to the vaccine even though she received it 9 days before, if it was possible that she was exposed to the virus and since she already received the vaccine if it will test false positive, and if she tested positive will she still be able to receive the 2nd dose. Information on the lot/batch number has been requested.",Not Reported,,Yes,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,,,,,"['Body temperature', 'Pyrexia']",1,PFIZER\BIONTECH, 1051510,UT,82.0,M,"Patient developed persistent fevers and weakness and loss of appetite that continued for about 3 weeks after getting the vaccine. There was a delay of about a day from getting the vaccine that he developed symptoms. He came to the hospital at today, 2/23/2021 because of the persistence of his symptoms. Vitals were stable and within normal range, but he had elevated creatinine to 1.66, unknown baseline. Troponin was also elevated to 0.08 without symptoms of ischemic heart disease. EKG was normal.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/02/2021,02/05/2021,3.0,OTH,amlodipine atorvastatin xeljanz carvedilol valium folate indapamide irbesartan potassium tamsulosin ambien,none,Diffuse idiopathic skeletal hyperostosis hypertension coronary artery disease,,none,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Asthenia', 'Blood creatinine increased', 'Decreased appetite', 'Electrocardiogram normal', 'Pyrexia', 'Troponin increased']",UNK,PFIZER\BIONTECH,IM 1051511,FL,72.0,F,"The morning following the vaccination, I woke up with a fever of 100.6, damp nightgown and sheets, very mild chills, some stomach bloating , and severe muscle aches and pains throughout my body. I was also so fatigued that I could do nothing all day except lay on the couch or in bed. I felt better that night around 8 PM. The injection site was also swollen, red and painful for about 5-6 days. Today, it was itchy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/16/2021,1.0,OTH,"Prozac, Montelukast, Calcium, Vit. D3, Vit. E, Vit. C, Magnesium, Glucosamine Chondroitin, Zinc - all taken at 9:45 AM",None,"Osteoporosis, Seasonal Allergies, Arthritis",,Erythromycin,"['Abdominal discomfort', 'Chills', 'Fatigue', 'Injection site erythema', 'Injection site pruritus', 'Injection site swelling', 'Myalgia', 'Pain', 'Pyrexia']",2,MODERNA,IM 1051512,MA,61.0,F,"Large itchy sore welt appeared on day 8 after first vaccine below the injection site. Looked like a hive at first. Applied hydrocortisone cream with relief. This rash is,still present 12 hours later. In morning had some fleeting jaw,pain too. Arm was,sore few days then no symptoms until today. Read about this on Google, seems to fit COVID arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/15/2021,02/23/2021,8.0,PHM,Vitamin D 2000mg daily,None,None,,"Penicillin, Amoxicillin, Erythromycin","['Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site urticaria', 'Pain in extremity', 'Pain in jaw']",1,MODERNA,IM 1051513,TX,36.0,F,"Tingling in injection arm, numbness and tingling in lips",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/23/2021,1.0,PVT,"Carvedilol, Pristque, metformin",,Diabetes Hypertension Anxiety,,Nkda,"['Hypoaesthesia oral', 'Paraesthesia', 'Paraesthesia oral']",1,MODERNA,IM 1051515,TX,50.0,F,"10 days post 2nd Covid-19 Vaccine administration I had an anaphylactic response of unknown origin. Extremely itchy eyes, palms of hands, soles of feet, progressed to shortness of breath, Bradycardic, oxygen saturation in 80s even after administration of IM epinephrin, hypotensive, swollen face, neck and tongue, severe vomiting. EMS transported me to hospital mentioned above. IV started in ambulance where IV epinephrin, IV fluids, IV Benadryl, IV solumedrol were all given prior to arrival at the ER. ER then administered more steroids and anti nausea meds and sent me home after observation and stabilization with prescription for epi pen and prednisone.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/02/2021,02/12/2021,10.0,PVT,NP Thyroid Wellbutrin Adderall,None,"Hypothyroidism, ADD",,"latex, ancef, avocado, apple, strawberry, veal, shellfish, wheat,","['Anaphylactic reaction', 'Bradycardia', 'Dyspnoea', 'Eye pruritus', 'Hypotension', 'Oxygen saturation decreased', 'Pruritus', 'Swelling', 'Swelling face', 'Swollen tongue', 'Vomiting']",2,MODERNA,IM 1051516,,76.0,F,"The day after sx developed; severe chills, some nausea, some body aches, headache. Rested all day and by the next day (day 2 after injection) I felt 95%. Took 2 Tylenol at bedtime on the day with the sx. No other OTC drugs. Did not contact my physician or felt the need to; really not bad sx.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/20/2021,1.0,PVT,"lisinopril, hydrochlorthiazide, amlodipine, atorvastatin",none,very controlled HBP,,,"['Chills', 'Headache', 'Nausea', 'Pain']",2,MODERNA, 1051517,CA,25.0,F,"Psychosis, altered sense of reality, fear of attack, distrust of partner, lasting about 4 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/23/2021,1.0,OTH,None,"Mononucleosis, C. Diff",Ehlers Danlos Syndrome,,None,"['Altered state of consciousness', 'Panic attack', 'Psychotic disorder']",2,PFIZER\BIONTECH,UN 1051518,WA,57.0,F,"Localized swelling, heat, redness and itching from day of vaccination to 2/21/2021. At that point swelling went down and a depression and possible muscle atrophy at same site. Localized tenderness persists.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/21/2021,25.0,PVT,"Multi-vitamin, Flonase",None,Rheumatoid arthritis,Localized inflammation at site usually lasts a day or two with any vaccination.,"Penicillin, augmentin, sulfa","['Injection site erythema', 'Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",UNK,MODERNA, 1051519,CA,63.0,F,The injection was at 10:06am. At 10:07am felt nauseated and dizzy. Waited 15 minutes before proceeding home. At 10:31am throat began to close and tongue became swollen. Lips and gums were numb. Breathing became difficult as was swallowing. Rapid heartbeat. Called 911. Pt was taken to the hospital. Administered Benedryl and possibly a steroid. Stayed overnight in the hospital.,Not Reported,,Yes,Yes,1.0,Not Reported,Y,02/04/2021,02/04/2021,0.0,PUB,None.,None.,None.,,None.,"['Cyanosis', 'Dizziness', 'Dysphagia', 'Dyspnoea', 'Heart rate increased', 'Hypoaesthesia oral', 'Hypopnoea', 'Nausea', 'Swollen tongue', 'Tachycardia', 'Throat tightness']",1,PFIZER\BIONTECH,IM 1051520,CO,27.0,F,"Around 2/19-2/20: mildly painful in upper left arm, not at the injection site but more in the region of my triceps. 2/21: slight itchiness in the same region described above 2/22: ~10 days after the 1st vaccine began having red lesions (2) on my left upper arm. Not at the injection site, but the back portion of my arm. Lesions started out painful, firm, red, risen, hot to the touch and pruritic. Lesions got much larger throughly the day and overnight.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/22/2021,9.0,PHM,SprinTec,None,Asthma,,Erythromycin,"['Pain in extremity', 'Pruritus', 'Rash', 'Urticaria']",1,MODERNA,IM 1051521,CA,84.0,F,"Redness, itching, hot",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/21/2021,13.0,UNK,"Celebrex, tramadol, gabapenton, amlodopine, atenalol, levothroxine,",Noneirregular,"Irregular heartbeat, arthritis, spinal stenosis",,"Penicillin, codeine","['Erythema', 'Pruritus']",UNK,MODERNA, 1051522,WI,88.0,M,Patient brought to emergency department at 2210 with concern for stroke d/t left sided weakness. Upon arrival patient appeared to have seizure like activity and was given 2mg of ativan and keppra 1000mg. Patient remained able to converse with providers during episode. Seizure activity/muscle twitching resolved after ativan/keppra administration. At the time of filing this report the patient is being admitted to the hospital.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/22/2021,02/23/2021,1.0,PVT,"allopurinol, amantadine, apixaban, vitamin C, atorvastatin, flonase, folic acid, mucinex, atrovent, irbesartan, multivitamin, methotrexate, metoprolol, montelukast, vitamin E",,"hypertension, hyperlipidemia, coronary artery disease, atrial fibrillation, rheumatoid arthritis, h/o SDH (10/2020)",,mold,"['Atrial fibrillation', 'Blood creatinine increased', 'Blood potassium increased', 'Blood urea increased', 'Cerebrovascular accident', 'Computerised tomogram head normal', 'Full blood count normal', 'Hemiparesis', 'International normalised ratio normal', 'Muscle twitching', 'Seizure like phenomena']",2,PFIZER\BIONTECH,IM 1051523,IL,71.0,F,"Experienced Chest pain and dizziness shortly after the first vaccine shot, but did not last too long. Is this a normal side effect of the vaccine shot?",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,PVT,,,,,,"['Chest pain', 'Dizziness']",UNK,PFIZER\BIONTECH, 1051524,MS,37.0,F,"Rash on arm, Itchy, sore",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,UNK,None,None,"Colon cancer polyps, Migraine, back pain",,Nystatin Allergy,"['Limb discomfort', 'Pruritus', 'Rash']",1,MODERNA,SYR 1051525,CA,44.0,M,"Redness, swelling, hard and hot to the touch at injection site. Showed up 8 days post vaccination and lasted for a couple of days. Treated with ibuprofen and ice. No medical treatment sought.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,02/05/2021,8.0,UNK,None,None,None,,None,"['Injection site erythema', 'Injection site induration', 'Injection site swelling', 'Injection site warmth']",1,MODERNA,SYR 1051526,AZ,45.0,M,"Roughly 30 minutes after administration of vaccine patient endorsed weakness, dizziness and shortness of breath. His blood pressure and heart rate increased during the event. He was treated with epinephrine 0.3mg IM due to concern for anaphylaxis and transferred to the ER via EMS. In the ER his vitals were stable and he was observed in the ER for 3 hours, with improvement in his symptoms. During the course of his stay he was treated with Benadryl, dexamethasone and albuterol. He presented with no hives, pharyngeal edema, wheezing, hypoxia or nausea/vomiting/diarrhea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PVT,Amlodipine Lisinopril Omeprazole,None,Hypertension GERD,,None,"['Asthenia', 'Blood pressure increased', 'Blood sodium decreased', 'Chest X-ray normal', 'Dizziness', 'Dyspnoea', 'Heart rate increased', 'Troponin normal']",UNK,PFIZER\BIONTECH, 1051527,CA,74.0,M,"Had the red splotch and itchiness around the injection site at 8 days after. Still there slightly, but not a big bother.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/22/2021,8.0,PHM,atorvastatin (10mg daily) alendronate (70mg weekly) aspirin (325mg daily) vitamin d (1000iu),none,none,,none,"['Injection site erythema', 'Injection site pruritus']",UNK,MODERNA, 1051528,UT,68.0,M,"Fever of 102 at 10:30 pm; chills; fatigue. I had C19? in early Nov 2020 and was in hospital from Nov 19-22, 2020",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/23/2021,0.0,PUB,Atorvastatin,"Within 12 hours of vaccination I had a temp of 102. I am chilling, fatigue and arm soreness",None,,None,"['Body temperature increased', 'Chills', 'Fatigue', 'Pyrexia']",1,MODERNA, 1051530,HI,43.0,F,"Symptoms of anxiety, hand and face skin tingling, and mild SOB began at 2:50 PM. Patient stated she had a history of anxiety. BP 132/94, Pulse 124, O2: 98% (measured with finger pulse oximeter). At 3:12 symptoms progressed to blue lips, cramping of hands, complaint of ""weight on the chest"", EMS was called. Pulse was 112, O2 was 98%. No rashes, swelling, or nausea noted. Had patient lie down on a yoga mat and helped her with anxiety reduction strategies, gave her sips of water. Transferred to EMS at 3:26 PM. Patient was evaluated, recovered, and released on-site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,OTH,None,None,None,,None,"['Anxiety', 'Blood pressure increased', 'Chest discomfort', 'Cyanosis', 'Dyspnoea', 'Heart rate increased', 'Muscle spasms', 'Paraesthesia']",1,MODERNA,IM 1051531,WI,68.0,F,Diarrhea for two days and some weakness from the diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/21/2021,2.0,OTH,,None,High blood pressure Diabetes,,Sulfa Penicillin,"['Asthenia', 'Diarrhoea']",2,PFIZER\BIONTECH,IM 1051532,CA,33.0,M,"Low grade fever. Normal body temperature is 97.6�F, 99.8�F twenty four hours after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,OTH,"Biktarvy, D-amphetamine, and Vyvanse",Food-borne gastroenteritis,AIDS,,,"['Body temperature increased', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1051533,,46.0,F,"Uniformly erythematous, warm rash spreading from the site of the injection and distally down the arm; started 10 days after injection. Clinically consistent with cellulitis however non painful and occasionally pruritic so concerned for allergic component still.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/19/2021,10.0,MIL,,None,"PCOS, preDM",,PCN - 'peeling skin rash',"['Injection site pruritus', 'Injection site rash', 'Injection site warmth', 'Rash erythematous']",1,MODERNA,IM 1051534,CO,69.0,F,"""COVID arm"": about 5 or 6 days after receiving the injection, a rash appeared, with itching and minor swelling. This lasted 2-3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/18/2021,5.0,WRK,"cevimeline 30 mg, levothyroxine 75 mcg, cyclosporine eye drops",None,"Sjogren's syndrome, bronchiectasis, hypothyroidism",,Lamisil,"['Pruritus', 'Rash', 'Swelling']",UNK,MODERNA,IM 1051535,IL,70.0,F,"My mother complained of a severe headache within 1 hour of receiving the injection. 18 hours later she was rushed to the the ER with a Hemorrhagic stroke. Hospitalized for 3.5 days, cognitive impairment remains, resulting in the need for rehabilitation therapy.",Not Reported,,Yes,Yes,3.0,Yes,N,02/19/2021,02/19/2021,0.0,UNK,,,,,,"['Cognitive disorder', 'Computerised tomogram', 'Haemorrhagic stroke', 'Headache', 'Magnetic resonance imaging']",1,PFIZER\BIONTECH,SYR 1051536,,40.0,F,Day 7 minor itching at injection site. Day 8 mild to moderate itching with tenderness. Day 9 hot red patch along with itch and tenderness. Day 10 itch less while redness is bigger and tender. Red patch is really hot it melt the ice fast.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/20/2021,7.0,PHM,,,"Hbp, prediabetes, gout, environmental allergies, fibromyalgia.",,Latex Penicillin,"['Injection site pain', 'Injection site pruritus', 'Injection site reaction', 'Injection site warmth']",UNK,MODERNA, 1051537,MI,79.0,F,Moderna COVID-19 Vaccine EUA,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/23/2021,6.0,PVT,Quinapril and Rosuvastatin,Diabetes,Diabetes,,Iodine and Atorvastatin,['Unevaluable event'],UNK,MODERNA, 1051538,UT,,U,"Dizziness, Vasovagal episode almost 2 hours post vaccine. Heart palpitations followed by high blood pressure. Treated with IM dexamethasone 8mg & Verapamil 40mg.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,PUB,,,,,,"['Blood pressure increased', 'Dizziness', 'Hypertension', 'Palpitations', 'Presyncope']",2,PFIZER\BIONTECH,IM 1051541,CA,68.0,M,"Red Rash on Left Arm about 3"" -4"" around injection site. Treated with Cortisone",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/20/2021,15.0,PVT,metformin avorstatin,,mild type II diabetes,,penicillin,"['Injection site erythema', 'Injection site rash']",1,MODERNA,SYR 1051559,NY,69.0,M,"Pt started with weakness approx. 14 hours after the vaccine. Pt said he was so weak he fell out of bed and was on the ground for approx. three hours until he was able to get up. He has had nausea, vomiting and diarrhea. He came into the ER complaining of shortness of breath and chest pressure. Pt has received Normal Saline fluid, chest x ray and is being admitted to the hospital for acute renal failure.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/19/2021,02/20/2021,1.0,PVT,"Vasotec, Advair Diskus, Allopurinol",No other illness at time of vaccination or one month prior to vaccination.,Pt has a history of asthma and aortic stenosis.,,No known food or drug allergies.,"['Acute kidney injury', 'Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Asthenia', 'Blood chloride decreased', 'Blood creatinine increased', 'Blood sodium decreased', 'Blood urea increased', 'Chest X-ray abnormal', 'Chest discomfort', 'Diarrhoea', 'Dyspnoea', 'Dysstasia', 'Fall', 'Glomerular filtration rate decreased', 'Nausea', 'Troponin I increased', 'Troponin increased', 'Vomiting']",2,MODERNA,IM 1051563,GA,60.0,M,"1 day post second Covid 19 vaccine patient experienced severe headache that progressively intensified and loss of vision out of the right eye. Subsequently, he presented to the ED and was found to have a left occipital lobe intraparenchyma hemorrhage & 1-acute subdural hemorrhage posterior left tentorial. He was air transport to another facility for treatment:/monitoring. He is currently still admitted . He remains without right eye vision.",Not Reported,,Yes,Yes,,Yes,N,02/15/2021,02/16/2021,1.0,OTH,Hydralazine Metoprolol Atrovastatin Phoslo,,"ESRD, HTN controlled with meds, CAD",,Norvasc Lisinopril,"['Blindness', 'Cerebral haemorrhage', 'Computerised tomogram head abnormal', 'Headache']",2,PFIZER\BIONTECH,IM 1051569,FL,67.0,F,"Pt. at 9:05 am at observation line was having weakness of the body, dizziness and felt a heat flash over her body. Paramedics assessed pt. once symptoms subsided the paramedics let pt. leave tent 1.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,OTH,"atenolol, losardin, hydrox",,HTN,,aspirin,"['Asthenia', 'Dizziness', 'Feeling hot']",1,PFIZER\BIONTECH,IM 1051570,FL,69.0,F,"Pt. at 9:05 am at observation line was having difficulty breathing, throat tickling sensation. Paramedic assessed pt. once symptoms subsided they released the pt. to leave.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,OTH,"Synthroid, losartan, lipitor",,HTN,,nka,"['Dyspnoea', 'Pharyngeal paraesthesia']",1,PFIZER\BIONTECH,IM 1051573,DE,57.0,F,"Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,SEN,,,,,,"['Injection site pain', 'Pruritus']",2,PFIZER\BIONTECH,IM 1051574,NY,43.0,F,"Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,SEN,,,,,,"['Anaphylactic reaction', 'Chest discomfort', 'Discomfort', 'Pain']",1,PFIZER\BIONTECH,IM 1051575,MI,73.0,M,"presented to ED 2/12, day after vaccination and tested POSITIVE for COVID. Then full cardiopulmonary arrest w COVID pneumonia and ARDS on 2/17/21.",Not Reported,,Yes,Yes,,Not Reported,N,02/11/2021,02/17/2021,6.0,PVT,"amlodipine, atorvastatin, ASA, HCTZ, lisinopril, metformin",none,"type 2 DM, HTN, dyslipidemia",,NKMA,"['Acute respiratory distress syndrome', 'COVID-19 pneumonia', 'Cardio-respiratory arrest', 'SARS-CoV-2 test positive']",UNK,MODERNA, 1051578,PA,92.0,M,Error: Booster Given Too Early,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,SEN,,,,,,['Unevaluable event'],2,PFIZER\BIONTECH,IM 1051579,WA,82.0,M,Error: Wrong Dose of Vaccine - Too High,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/20/2021,0.0,OTH,,,,,,['Incorrect dose administered'],3,PFIZER\BIONTECH,IM 1051588,FL,69.0,F,"Pt in tent f1 at the observation lane felt tingling chest, paramedics assessed pt. Once symptoms subsided paramedics released the pt. to leave.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,UNK,SYNTHROID,,HYPERTHYROID,,NKA,['Paraesthesia'],1,PFIZER\BIONTECH,IM 1051609,NY,88.0,F,"left arm deltoid region is erythemous, tender to touch, and warm. local reaction to at covid injection site.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/21/2021,02/22/2021,1.0,PUB,,"gastroeneteritis, fatigue,unstable angina, acute myocardial infarction, dizziness and giddiness, coronary artery disease involving native coronary artery of native heart without angina pectoris,allergic rhinitis, acute anxiety, elevated blood pressure, elevated d-dimer, partial small bowel resection,history of chemothrapy,ductalcarcinoma in situ of breast,history of mastectomy, gerd, elevated troponin level, parastomal hernia without obstruction, small bowel obstruction, status post colostomy, diverticular stricture, diverticulitis larger, druse of left macula, epiretinal membrane, shoulder pain, right, pain in joint hand, left hand pain, pain of right thumb diverticulosis of colon without hemorrhage, supra ventricular premature beats,dyslipidemia, spinal stenosis, breast cancer, osteoarthritis involving lower leg, family history of malignant neoplasm of breast, mild mitral regurgitation,cardiomegaly hypertensive, benign neoplasm of stomach, reticule, diaphragmatic hernia without mention of obstruction or gangrene.",,,"Bactrim,codiene,lipitor,morphine,meloxicam,phenergin pain, sulfa antibiotics,vicodin,dilaudid [hydromorphone]","['Injection site erythema', 'Injection site pain', 'Injection site reaction', 'Injection site warmth', 'Local reaction']",2,MODERNA, 1051634,OH,82.0,M,"Pt with no previous history of abdominal aortic aneurysm presented to ER on 02.20.2021 with abdominal pain, weakness and BP of 50/30 via EMS. Abdominal pain started on 02.19.2021 approx 10:00 PM. Pain was described as severe in the left flank, radiating into the lower abdomen and worsened through the night. EMS was called around 11 AM. Pt CT Abd/Pelvis angiography shown Ruptured abdominal aortic aneurysm measuring up to 7.9 cm in diameter and 9.8 cm in length with active extravasation of IV contrast. Large volume of predominantly retroperitoneal hemorrhage. Pt was flown hospital for surgical intervention after being given 2 units of O neg blood with 2 L normal saline.",Not Reported,,Yes,Yes,,Not Reported,N,02/15/2021,02/19/2021,4.0,PUB,,None,CAD,,,"['Abdominal pain', 'Abdominal pain lower', 'Alanine aminotransferase decreased', 'Angiogram', 'Anion gap', 'Aortic aneurysm rupture', 'Aspartate aminotransferase normal', 'Asthenia', 'Atelectasis', 'Blood albumin decreased', 'Blood alkaline phosphatase decreased', 'Blood bilirubin normal', 'Blood calcium decreased', 'Blood chloride increased', 'Blood creatinine normal', 'Blood glucose increased', 'Blood lactic acid increased', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea normal', 'Carbon dioxide decreased', 'Computerised tomogram abdomen', 'Flank pain', 'Full blood count', 'Globulins decreased', 'Glomerular filtration rate decreased', 'Haematocrit decreased', 'Haemoglobin decreased', 'Infusion site extravasation', 'International normalised ratio increased', 'Mean cell haemoglobin concentration normal', 'Mean cell volume normal', 'Metabolic function test', 'Pain', 'Platelet count decreased', 'Protein albumin ratio normal', 'Protein total decreased', 'Prothrombin time prolonged', 'Red blood cell count decreased', 'Red cell distribution width normal', 'Retroperitoneal haemorrhage', 'SARS-CoV-2 antibody test negative', 'Transfusion', 'Troponin normal', 'Urine analysis normal', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 1051637,IN,77.0,M,"2/9 received 2nd vaccine in series. 2/10 mild headache and fatigue. 2/11 worsening headache, extreme fatigue, and general malaise. In bed except for bathroom use and minimal food consumption starting 2/11 until hospitalization on 2/17/2021.",Not Reported,,Yes,Yes,,Not Reported,N,02/09/2021,02/11/2021,2.0,PVT,,,"Hypertension, Chronic Kidney Disease Stage 2, DM2",,,"['Decreased appetite', 'Endotracheal intubation', 'Fatigue', 'Headache', 'Intensive care', 'Malaise', 'Pneumonia']",2,PFIZER\BIONTECH,IM 1051651,NY,58.0,M,"Abdominal pain, nausea and vomiting, shortness of breath, acidosis, hypoglycemia, death. Onset of abdominal pain was 30 minutes after administration of the vaccine followed by 20+ episodes of vomiting and dry heaving.",Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/23/2021,0.0,SCH,"Lisinopril, metoprolol, simvastatin, acetaminophen, ibuprofen, calcium carbonate, furosemide, diphenoxylate/atropine, magnesium chloride, omeprazole, Carafate, testosterone, vitamin D3, levothyroxine",None,Colon Cancer Hypothyroidism Hyperlipidemia GERD Hypertension,,NKDA,"['Abdominal pain', 'Acidosis', 'Activated partial thromboplastin time prolonged', 'Alanine aminotransferase increased', 'Angiogram pulmonary abnormal', 'Angiogram pulmonary normal', 'Anion gap', 'Ascites', 'Aspartate aminotransferase increased', 'Atelectasis', 'Atypical mycobacterial infection', 'Bilirubin conjugated', 'Blood albumin', 'Blood alkaline phosphatase increased', 'Blood bicarbonate decreased', 'Blood bilirubin', 'Blood creatinine increased', 'Blood glucose decreased', 'Blood lactic acid', 'Blood lactic acid normal', 'Blood pH decreased', 'Blood pH increased', 'Blood potassium decreased', 'Blood urea increased', 'Cholelithiasis', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram pelvis abnormal', 'Death', 'Dyspnoea', 'Enteritis', 'Fibrin D dimer', 'Hypoglycaemia', 'Ileus', 'International normalised ratio increased', 'N-terminal prohormone brain natriuretic peptide increased', 'Nausea', 'PCO2 increased', 'Pericardial effusion', 'Platelet count decreased', 'Pleural effusion', 'Proctitis', 'Retching', 'Troponin', 'Varices oesophageal', 'Vomiting', 'White blood cell count decreased']",1,MODERNA,IM 1051653,ME,77.0,M,"Moderate pain in chest behind sternum when breathing. Admitted to Hospital on 1 February 2021. Diagnosed as pericarditis. Treatment: Ibuprofen 600 mg 3x/day for 2 weeks, and Colchicine 0.6 mg 2x/day for 3 months.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/28/2021,02/01/2021,4.0,PVT,Rosuvastatin 20 mg 1tab/day Lisinopril/HCTZ 10-12.5 mg 1 tab/day Melatonin 10mg Vitamin D3 25 mg,None,High cholesterol High Blood pressure,,None,"['Chest pain', 'Painful respiration', 'Pericarditis']",1,PFIZER\BIONTECH,IM 1051666,OH,85.0,M,"Pt presented to ER with SOB on 01-29-2021. He was admitted to Healthcare with acute CHF exacerbation, elevated lactate, anemia and elevated d-dimer. Pt reports getting SOB getting up to go to the bathroom. Pt was intubated. He developed pulmonary edema. Pt expired on 02-02-2021 at 10:13 PM.",Yes,02/02/2021,Not Reported,Yes,4.0,Not Reported,N,01/29/2021,01/29/2021,0.0,PUB,,None,"CHF,DM2,OSA,HTN,Diabetic Neuropathy, CKD3",,"Heparin,Cipro,Imdur","['Anaemia', 'Arteriosclerosis', 'Blood lactic acid increased', 'Cardiac failure congestive', 'Chest X-ray abnormal', 'Computerised tomogram thorax abnormal', 'Computerised tomogram thorax normal', 'Condition aggravated', 'Death', 'Dyspnoea', 'Electrocardiogram normal', 'Emphysema', 'Endotracheal intubation', 'Fibrin D dimer increased', 'Mitral valve incompetence', 'Pulmonary oedema', 'Tricuspid valve incompetence']",1,PFIZER\BIONTECH,IM 1051675,WI,78.0,F,"Patient passed away on 2/1/21 at the Health System. She was there for congestive heart failure (CHF) which had been a problem for her since contracting COVID-19 (symptoms began 10/29/20 and tested positive 10/30/20). She had been to see her medical provider several times after her isolation period as well as a few trips to the hospital for, what they called ""CHF flare-ups"". Her last hospitalization began on January 30, 2021. Her social worker reported on t1/31/21 that ""she would likely be returning in another day or two"".",Yes,02/01/2021,Not Reported,Yes,,Not Reported,N,01/28/2021,02/01/2021,4.0,PUB,,congestive heart failure,congestive heart failure,,,"['Cardiac failure congestive', 'Condition aggravated', 'Death']",1,PFIZER\BIONTECH,IM 1051677,VA,78.0,M,I noticed that the left side of my mouth was a little droopy around 10:00am on 2/14/2021 but didn?t think anything of it. Then around 4pm my daughter saw me and noticed it as well. We went to the ED immediately and got a stroke rule out work up. There were no other deficits besides the left sided facial palsy.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/27/2021,02/14/2021,18.0,PVT,Aspirin 81mg daily Losartan 50mg daily Atorvastatin 40mg daily Fish oil One a day men?s vitamin,None,Hypertension Hyperlipidemia,,No known allergies,"['Activated partial thromboplastin time', 'Blood magnesium', 'Borrelia test', 'Brain natriuretic peptide', 'C-reactive protein', 'Chest X-ray', 'Computerised tomogram abdomen', 'Computerised tomogram head', 'Facial paralysis', 'Full blood count', 'Glomerular filtration rate', 'Glycosylated haemoglobin', 'Lipase', 'Lipids', 'Magnetic resonance imaging', 'Metabolic function test', 'Musculoskeletal foreign body', 'Procalcitonin', 'Red blood cell sedimentation rate', 'Troponin']",1,MODERNA,IM 1051678,AZ,70.0,M,"70-year-old male who presents to the emergency department for evaluation of abdominal pain. The patient was awakened from sleep this morning with severe sharp, stabbing pain in his epigastric region. Pain radiates into his lower abdomen and his back. He associates his symptoms with a bloating sensation. He took omeprazole with mild relief of symptoms. Symptoms recurred a few hours later. States that he became confused and diaphoretic at that time. He called EMS to transport him to the emergency department. The patient was found to have an objective fever at that time. He was given Zofran; Notes COVID vaccine several days earlier; on antibiotics, will need cholecystectomy while in hospital",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/19/2021,02/22/2021,3.0,PVT,"aspirin, atorvastatin, omeprazole, miralax, probiotic, vitamin C",none,"cataract, CAD, diverticulitis, hyperlipidemia, sleep apnea, kidney stone surgery",,none,"['Abdominal distension', 'Abdominal pain', 'Abdominal pain lower', 'Abdominal pain upper', 'Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Back pain', 'Blood alkaline phosphatase increased', 'Body temperature increased', 'Cholecystectomy', 'Confusional state', 'Hyperhidrosis', 'Lipase increased', 'Pain', 'Pancreatitis acute', 'Pyrexia', 'Sleep disorder']",1,PFIZER\BIONTECH,IM 1051688,OH,74.0,M,None stated.,Not Reported,,Not Reported,Yes,,Not Reported,N,01/29/2021,,,PUB,,,,,,['Unevaluable event'],1,PFIZER\BIONTECH,IM 1051689,MI,88.0,F,Presented to emergency department on 2/20/21 with shortness of breath and nasal congestion with symptoms starting 2 days prior to presenting. Had virtual appointment on 2/19/21 with primary care provider for sinus infection and was started on Bactrim. Patient was discharged on 2/23/21 then presented back to ED on 2/23/21 and was re-admitted. Patient is currently admitted at the time of reporting.,Not Reported,,Not Reported,Yes,5.0,Not Reported,N,02/11/2021,02/20/2021,9.0,PVT,"Ventolin, amlodipine, anastrozole, Eliquis, aspirin, atorvastatin, Symbicort, Calcium+D, Flonase, levothyroxine, mag-ox, meclizine, metoprolol, montelukast, Verzenio","Atrial fibrillation, metastatic breast cancer","hypertension, hypercholesteremia, hypothyroid, chronic kidney disease stage 3",,"Amoxicillin (nausea), diphenhydramine (delirium)","['COVID-19', 'Dyspnoea', 'Nasal congestion', 'SARS-CoV-2 test positive', 'Sinusitis']",1,PFIZER\BIONTECH,SYR 1051699,OH,91.0,M,Death on 02.15.2021.,Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/15/2021,19.0,PUB,,None,COPD,,,['Death'],1,PFIZER\BIONTECH,IM 1051703,TX,79.0,M,"Patient had sore arm the first day, the second day patient had slurred speech, couldn?t remember or say words, went to the hospital, CT scan and it showed a stroke, AFib came back that had been resolved, he had to be bagged for 2 minutes because he stopped breathing, MD told him the covid shot may have reacted negatively with his previous heart surgery",Not Reported,,Yes,Yes,6.0,Not Reported,N,02/16/2021,02/17/2021,1.0,PVT,"Avodart 0.5mg daily, anastrozole 1 mg weekly, atorvastatin 20 mg daily, loratadine 10 mg daily as needed for allergies, acetaminophen 500 mg every 6 hours as needed for pain, Colace 100 mg daily, metoprolol succinctness 50 mg daily,, coQ 10",None,"Open heart with triple bypass, aortic valve replacement March 2020, left femur ORIF February 2020",,Cipro and sulfa,"['Atrial fibrillation', 'Cerebrovascular accident', 'Computerised tomogram head abnormal', 'Condition aggravated', 'Dysarthria', 'Laboratory test', 'Magnetic resonance imaging', 'Pain in extremity', 'Respiratory arrest']",2,MODERNA,IM 1051710,MN,80.0,F,"On 2/2 received 1 st dose of vaccine. On 2/14 developed nausea, vomiting and diarrhea. Admitted to hospital and found to have a troponin of 72 and coronary angiogram done. Endomyocardial biopsy revealed myocyte damage and mixed inflammatory infiltrate concerning for myocarditis. Patient ultimately has started to recover with treatment of methylpred 1 gram x 3 days.",Not Reported,,Yes,Yes,10.0,Not Reported,Y,02/02/2021,02/14/2021,12.0,PVT,Multivitamins,None,Pancreatic cyst Spondylosis Osteoarthritis Ulcerative colitis-not on medication,,None,"['Angiocardiogram', 'Biopsy heart abnormal', 'Cardiac disorder', 'Diarrhoea', 'Myocarditis', 'Nausea', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 test negative', 'Troponin increased', 'Urine retinol binding protein increased', 'Vomiting']",1,PFIZER\BIONTECH,IM 1051712,FL,78.0,F,"arm is red and swollen , now is the size of two grapefruits , sx getting better,area still feels hot",Not Reported,,Not Reported,Yes,,Not Reported,U,02/19/2021,02/19/2021,0.0,UNK,,,anaphylaxis's to a bug bite years ago,,,"['Erythema', 'Feeling hot', 'Peripheral swelling']",1,MODERNA,IM 1051713,WI,72.0,M,"Covid 19 vaccine was administered at 2:45 pm on 2-21-21. By 2:55 pm patient began to experience Confusion and loss of short term memory. He suddenly did not know where is was, how he got there, or why he was there. He continuously asked those questions throughout the balance of the day. The nurses on duty in the clinic got a wheel chair and escorted us to the hospital ER in the same building. He was immediately taken to a room where a doctor met us and began asking him questions. The Dr quickly ordered a multitude of tests. Results shown in item 19",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/21/2021,02/21/2021,0.0,OTH,"OTC and Vitamins: C, D, zinc, ocuvite, aspirin 81 mg, tylenol, Dulcolax RX: furosemide, hydrocodone, pantoprazole, potassium chloride, pravastin, silodosin, stool, eliquis, symbicort, voltaren, zonisamide",none,"high blood pressure, heart, atrial fibrillation, COPD",,"shellfish, seasonal rhinitis","['Alanine aminotransferase normal', 'Albumin globulin ratio normal', 'Amnesia', 'Angiogram cerebral normal', 'Anion gap', 'Arteriogram carotid normal', 'Aspartate aminotransferase normal', 'Basophil count normal', 'Basophil percentage', 'Bilirubin urine', 'Blood albumin normal', 'Blood alkaline phosphatase increased', 'Blood bilirubin normal', 'Blood calcium normal', 'Blood chloride normal', 'Blood cholesterol normal', 'Blood creatinine normal', 'Blood glucose increased', 'Blood potassium normal', 'Blood sodium normal', 'Blood triglycerides normal', 'Blood urea nitrogen/creatinine ratio increased', 'Blood urea normal', 'Blood uric acid normal', 'COVID-19', 'Carbon dioxide normal', 'Cerebral atrophy', 'Chest X-ray normal', 'Claustrophobia', 'Computerised tomogram head normal', 'Confusional state', 'Differential white blood cell count normal', 'Electrocardiogram', 'Eosinophil count normal', 'Eosinophil percentage', 'Full blood count', 'Glomerular filtration rate decreased', 'Glucose urine absent', 'Haematocrit decreased', 'Haemoglobin decreased', 'High density lipoprotein decreased', 'Low density lipoprotein normal', 'Lymphocyte count normal', 'Lymphocyte percentage decreased', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging brain abnormal', 'Mean cell haemoglobin concentration decreased', 'Mean cell haemoglobin decreased', 'Mean cell volume abnormal', 'Mean cell volume decreased', 'Mean platelet volume normal', 'Metabolic function test', 'Monocyte count normal', 'Monocyte percentage', 'Neutrophil count normal', 'Neutrophil percentage increased', 'Nitrite urine absent', 'Perfusion brain scan normal', 'Platelet count normal', 'Protein total decreased', 'Protein urine absent', 'Red blood cell count normal', 'Red cell distribution width increased', 'SARS-CoV-2 test positive', 'Scan with contrast', 'Specific gravity urine normal', 'Total cholesterol/HDL ratio normal', 'Urine analysis normal', 'Urine ketone body absent', 'Urine leukocyte esterase', 'Urobilinogen urine', 'White blood cell count normal', 'White matter lesion', 'pH urine normal']",1,PFIZER\BIONTECH,IM 1051720,FL,61.0,M,"1/04/2021, 1/25/2021 Pfizer ej1685, en5318 Reports that he ""passed out"" on 1/6 at work, taken to ER and was diagnosed with kidney failure & hyperkalemia, also positive for covid. Hospitalized till 1/13, underwent dialysis. Received 2nd vaccination 1/25, once again ""passed out"" in breakroom while at work. Pt was awoken after approx 1 hour, unable to move arm at that time, went home and did not seek medical care at that time. Pt was re-hospitalized on 2/2/2021 due to difficulty breathing & AMS. Dx with pneumonia & hyperkalemia at that time, discharged home 2/11/2021. Continues on hemodialysis 3x/week.",Not Reported,,Not Reported,Yes,7.0,Not Reported,N,01/04/2021,01/06/2021,2.0,WRK,Levemir amlodipine gabapentin rosuvastatin losartan gemfibrozil hydralazine carvedilol glipizide Trulicity,,diabetes hypertension high cholesterol,,,"['COVID-19', 'Dyspnoea', 'Haemodialysis', 'Hyperkalaemia', 'Joint range of motion decreased', 'Loss of consciousness', 'Mental status changes', 'Pneumonia', 'Renal failure']",1,PFIZER\BIONTECH,IM 1051727,VA,77.0,F,"Emergency Dept visit on 2/17/2021 at Hospital, with complaints of wrist pain. Diagnosed with possible gout from recent Lasix initiation or reactive arthritis from COVID vaccine received at pharmacy. Admitted to Hospital on 2/23/2021 with diffuse body aches, joint pains, weakness and episode of afib/RVR. Remains hospitalized on 2/24/2021",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/15/2021,02/17/2021,2.0,PVT,Prednisone Hydralazine Omeprazole Loratidine Lasix Cipro Desvenlafaxine Succinate Insulin NPH Nitroglycerine Glipizide Carvedilol Aspirin,recently started on Lasix history of gout,anxiety angina CAD depression degenerative joint disease acid reflux hyperlipidemia HTN,,hydromorphone sulfa adhesive Benadryl latex morphine,"['Arthralgia', 'Asthenia', 'Atrial fibrillation', 'Blood uric acid increased', 'C-reactive protein decreased', 'Gout', 'Pain']",1,MODERNA,IM 1051733,IL,85.0,M,"Received 2nd dose of Moderna on 1/26/21. Went to the hospital and admitted 2/21/21-2/22/21 for UTI, weakness, and neck pain.",Not Reported,,Not Reported,Yes,2.0,Not Reported,,01/26/2021,02/21/2021,26.0,SEN,,,,,,"['Asthenia', 'Neck pain', 'Urinary tract infection']",2,MODERNA,IM 1051748,OH,80.0,M,Tested positive for Covid-19 on 2/11/2021. Admitted into hospital. Stayed for 7 days. Released on oxygen,Not Reported,,Not Reported,Yes,7.0,Not Reported,U,02/04/2021,02/11/2021,7.0,PHM,Hydrochlorothiazide 25mg Gipizide ER 5mg,Diabetes,,,,['COVID-19'],1,MODERNA,IM 1051768,FL,,M,"Tested positive for COVID-19; More aches and pains; Tiredness; Sleeping more; Low-grade fever; A spontaneous report was received from a consumer concerning her husband, a 69-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced low-grade fever/MedDRA PT: Fever, Tested positive for COVID-19/MedDRA PT: COVID-19, more aches and pains/MedDRA PT: Pain, tiredness and sleeping more/MedDRA PT: hypersomnia. The patient's medical history was not provided. Concomitant medication information was not provided. On 14 Jan 2021, the patient developed a low-grade fever. On 16 Jan 2021, the patient tested positive for COVID 19. On 19 Jan 2021, the patient received the first dose of two planned doses of mRNA-1273 in the right arm for prophylaxis of COVID-19 infection. On an unknown date, patient developed ""more aches and pains, tiredness and sleeping more. The patient was seen at Urgent Care. Treatment included Vitamin C, Vitamin D, azithromycin, zinc and ""mucus relief"". He was hospitalized for 12 days. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events of low-grade fever, tested positive for COVID-19, more aches and pains, tiredness and sleeping more was considered unknown.; Reporter's Comments: This case concerns a 69-year-old male was hospitalized for a serious unexpected event of COVID-19, as well as NS unexpected events of hypersomnia and pain, and NS expected events of fever and fatigue. The event of COVID-19 occurred 12 days after the first dose of mRNA-1273. Treatment not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded",Not Reported,,Not Reported,Yes,,Not Reported,U,01/19/2021,01/14/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['COVID-19', 'Fatigue', 'Hypersomnia', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,MODERNA,OT 1051769,GA,,U,"vaccine overdosage administered to 4 patients; A spontaneous report was received on 09 FEB 2021 from a healthcare professional concerning an unknown age, unknown gender patients who received Moderna's COVID-19 vaccine, higher dose than 0.5 ml. The patients medical history was not provided. No relevant concomitant medications were reported. On unknown date, four patients received their one of two planned doses of mRNA-1273(Lot number: unknown), for the prophylaxis of COVID-19 infection. The healthcare professional reported that four patients were given a higher dose than 0.5 ml of Moderna's COVID-19 vaccine at their office. Treatment for the event was not provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, vaccine over dosage administered to 4 patients, was considered recovered/resolved.; Reporter's Comments: This report refers to 4 cases of accidental vaccine overdose, administered for mRNA-1273, lot # unknown with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Accidental overdose'],1,MODERNA,OT 1051770,,73.0,F,"Cellulitis; A spontaneous report was received from a consumer concerning a 73-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and cellulitis. The patient's medical history was included lymphedema in her legs. Concomitant product use was not provided. On 19 Jan 2021, prior to the onset of symptoms, the patient received their first dose of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient was hospitalized on 01 Feb 2021 for cellulitis. Treatment for the events included intravenous antibiotics, which the patient reported were antibacterial medications. The patient was switched to oral antibiotics but remained hospitalized. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/19/2021,02/01/2021,13.0,UNK,,,Medical History/Concurrent Conditions: Lymphedema,,,['Cellulitis'],1,MODERNA,OT 1051771,CA,65.0,F,"area was hot to touch; really red area below where she got her injection; 2&1/2"" high and 4"" wide; little soreness afterwards; she suspects that the injection was given subcutaneous instead of intramuscular; A spontaneous report was received from a consumer regarding herself, a 65-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and suspects the injection was given subcutaneous instead of intramuscular/inappropriate route of vaccination, area was hot to touch/vaccination site warmth, little soreness afterwards, really red area below where she got her injection/vaccination site erythema, and site 2&1/2 inches high and 4 inches wide/vaccination site swelling. The patient's medical history was not provided. Products known to have been used by the patient were not included. On 25 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 25 Jan 2021, the patient reported that she experienced a little soreness afterward and felt as if the dose was given subcutaneously instead of intramuscularly. On 05 Feb 2021, approximately 11 days after the patient received the vaccine, she reports that she had warmth, swelling and a raised circle at the injection site. Treatment information was not provided. Consent to follow up was obtained. Action taken with mRNA-1273 was not provided. The outcome of the events, suspects the injection was given subcutaneous instead of intramuscular, area was hot to touch, little soreness afterwards, really red area below where she got her injection, site 2&1/2 inches high and 4 inches wide, was unknown.; Reporter's Comments: This case concerns a 65-year-old female who had a NS unexpected event of Incorrect route of product administration with associated adverse events of NS unexpected vaccination site warmth and NS expected vaccination site pain, vaccination site erythema, vaccination site swelling. Event onset the same day as first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical History not provided),,,"['Incorrect route of product administration', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling', 'Vaccination site warmth']",1,MODERNA,OT 1051772,CO,,M,"Patient received the Moderna second dose 15 minutes after 6 hour throw away time; A spontaneous report was received from a nurse concerning a 24-year-old male patient, who was administered Moderna's second dose fifteen minutes after six hours throw away time. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their second planned doses of mRNA-1273 (Batch number: 09L20A) on 09 Feb 2021 for the prophylaxis of COVID-19 infection. On 09 Feb 2021 the patient received the second dose of vaccine,however the dose suffered an excursion and remained out of the refrigeration 15 minutes after the 6 hour throw away time after being punctured. The nurse states it was only 15 min after the 6 hour time frame. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered Moderna's second dose fifteen minutes after six hours throw away time, was considered resolved.; Reporter's Comments: This report refers to a 24-year-old male who had an NS unexpected event of Expired product administered for mRNA-1273, lot # 09L20A with no associated adverse events. The event occurred the same day as the second dose of mRNA-1273. Reporter stated dose was affected by an excursion out of refrigeration more than 6 hours after being punctured, given 15 minutes after the 6 hours. Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Expired product administered'],1,MODERNA,OT 1051773,MD,,M,"felt some drops going down; felt some drops going down; A spontaneous report was received from a consumer concerning a 74-year-old male patient who stated he received the Moderna COVID-19 vaccine and as the needle was being withdrawn, he felt some drops going down his arm/underdose. The patient's medical history was not provided. Products known to have been used by the patient included statin, morniflumate, blood pressure medicine, and clonazepam. On 07 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection. The consumer received first dose of the Moderna COVID-19 vaccine on 07Feb2021. He received the shot on his left (non-dominant) arm. As the needle was being withdrawn, he felt some drops going down his arm. He is not sure whether he received the full dose or not. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the event was not reported.; Reporter's Comments: This report refers to a case of Vaccine underdose and exposure via skin contact for mRNA-1273 (Lot number: unknown) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/07/2021,02/07/2021,0.0,UNK,STATIN [ATORVASTATIN CALCIUM]; FLOMAX [MORNIFLUMATE]; Blood pressure medicine; CLONAZEPAM,,Medical History/Concurrent Conditions: No adverse event,,,"['Exposure via skin contact', 'Underdose']",1,MODERNA,OT 1051774,NJ,88.0,F,"Wasn't able to get second dose; A spontaneous report was received from a consumer concerning her mother(M-S) who is 88 year old female, who received her first dose of Moderna Covid -19 vaccine and couldn't take the 2nd dose as scheduled. The consumer's medical history was not provided except she had a pelvic fracture. Her relevant concomitant medications were not provided. No information on allergies. On 15-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of Covid-19 vaccine intramuscularly for the prophylaxis of Covid-19 infection. She couldn't take her 2nd dose due to hospitalization. She is being hospitalized for a pelvic break prior to her first dose of vaccine and been admitted in rehab facility since then. She is unable to receive her 2nd dose as scheduled. Action taken with 2nd dose of Moderna Covid-19 vaccine was unknown. The outcome of the event inappropriate schedule of vaccination is unknown at the time of report.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273. There were no reported adverse events associated with this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,,,UNK,,Pelvic fracture (Pelvic break),,,,['Inappropriate schedule of product administration'],1,MODERNA,OT 1051775,RI,49.0,F,"Needle leaked (Not sure if any of the dose got in to the patient's muscle); Needle leaked (Not sure if any of the dose got in to the patient's muscle); A spontaneous report was received from a healthcare professional concerning a 49-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: needle leaked (device connection issue), not sure if any of the dose got into the patient's muscle (vaccine underdose) The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 11 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot #: 031L20A) intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, while administering the vaccine to the patient, the nurse noted that the needle was not attached properly. The vaccine leaked and the reporter was not sure if the patient received any of the dose. Action taken with mRNA-1273 in response to the event was unknown. The event, needle leaked and not sure if any of the dose got into the patient's muscle, was considered resolved.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273. There were no reported adverse events associated with this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Device connection issue', 'Underdose']",1,MODERNA,OT 1051776,NJ,59.0,F,"barely soreness; all the liquid from the needle ran down arm; all the liquid from the needle ran down arm; A spontaneous report was received from a consumer concerning a 59-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and liquid from the needle ran down her arm and experienced barely soreness. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin 10 mg, amlodipine 2.5 mg, acidophilus, vit D, aspirin, and coQ10. On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. Patient stated that she had her 1st dose of the Moderna Covid-19 vaccine 26 Jan 2021 and felt all the liquid drip down her arm. She was sure if she got anything from the ""1st"" dose. She felt the needle go in, barely experienced soreness for that day. Treatment information was not provided. Action taken with the drug in response to the events is unknown. The outcome of the event barely soreness was resolved on 26 Jan 2021. The event vaccine underdose and device connection issue was considered resolved on 26 Jan 2021.; Reporter's Comments: Based on the current information and temporal association between the use of the product and the start date of soreness, a causal relationship cannot be excluded. The causality of events of vaccine underdose and device connection is not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,ATORVASTATIN; AMLODIPINE; ACIDOPHILUS BIFIDUS; VITAMIN D NOS; ASPIRIN [ACETYLSALICYLIC ACID]; COQ10 COMPLEX,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Device connection issue', 'Underdose', 'Vaccination site pain']",1,MODERNA,OT 1051777,CA,76.0,F,"Incomplete dose; A spontaneous report received from a consumer concerning a 76-year-old female patient who received the first dose of Moderna COVID-19 (mRNA-1273) vaccine and received incomplete dose. The patient's medical history was not reported. Concomitant medication was not reported. On 18 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch #: 025620A) intramuscularly for prophylaxis of COVID-19 infection. On 18 Jan 2021, When the nurse administered the vaccine, the patient was told that she was only going to receive a 0.25ml dose. The patient did not experience any side effects from the vaccine but would like to report that she did receive an incomplete dose. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was considered resolved on 18 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 vaccine, batch number 025620A, with no associated AEs. Causality of these events is not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/18/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Incorrect dose administered'],1,MODERNA,OT 1051778,PA,,U,"5 or 6 drops of vaccine dropped on patient's arm; syringe malfunction; A spontaneous report was received from a pharmacist concerning an unknown age and gender patient who experienced syringe malfunction and 5 or 6 drops of vaccine dropped on patient's arm during administration of Moderna's COVID-19 vaccine. Patient medical history was not provided. No relevant concomitant medications were reported. On 11 Feb 2021, patient received their one of two planned doses of mRNA-1273 (Lot/ batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection. On 11 Feb 2021, when they administered the vaccine to a patient, there was a syringe malfunction and 5 or 6 drops of vaccine dropped on patient's arm during administration of Moderna's COVID-19 vaccine. Treatment for the event was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, syringe malfunction and 5 or 6 drops of vaccine dropped on patient's arm during administration of Moderna's COVID-19 vaccine, were considered resolved.; Reporter's Comments: This report refers to a case of vaccine underdose and syringe malfunction, for mRNA-1273, lot number unknown, with no associated AEs. Causality of these events is not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Device connection issue', 'Underdose']",1,MODERNA,OT 1051779,,,U,"Had one dose of Pfizer and then got first dose of Moderna and then another dose of Moderna; Had one dose of Pfizer and then got first dose of Moderna and then another dose of Moderna; A spontaneous report was received from a healthcare professional concerning a patient who had one dose of Pfizer and then got first dose of Moderna and then another dose of Moderna. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, patient received one dose of Pfizer vaccine for prophylaxis of COVID-19 infection. On unknown date, patient received their first of two planned doses of mRNA-1273 (Lot number: unknown), for prophylaxis of COVID-19 infection. On unknown date, patient received their second of two planned doses of mRNA-1273(Lot/ batch number: unknown), for prophylaxis of COVID-19 infection. Treatment for the events were not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, had one dose of Pfizer and then got first dose of Moderna and then another dose of Moderna, was considered resolved.; Reporter's Comments: This report refers to a case of Product administration error of Extra dose administered and Interchange of vaccine products for mRNA-1273, lot # unknown , with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Extra dose administered', 'Interchange of vaccine products']",1,MODERNA,OT 1051786,NJ,77.0,M,"Four days after receiving the first Phizer COVID-19 vaccination (2/7/2021) I began experiencing double vision. This double vision was intermittent, lasting for several hours at one time. This double vision persisted and worsened with double vision all day long. At the ER prior to discharge, Dr. diagnosed me with possible ""Ocular myasthenia gravis"" and prescribed me with Pyridostigmine Bromide. After having been 30mg of this medicine daily for 1 week, the double vision has not subsided. Starting today (2/24), I am beginning to take 60mg daily. This double vision continues today (2/24/2021) even with the newly prescribed medication",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/03/2021,02/07/2021,4.0,PVT,Omeprazole for Acid Reflux; Gabapentin for Back Pain; Simvastatin for Cholesterol,none,Acid Reflux and High Cholesterol,,none,"['Blood test', 'Computerised tomogram', 'Diplopia']",1,PFIZER\BIONTECH,SYR 1051802,GA,73.0,M,None noted at time injection was given. Patient received Moderna vaccine for 1st on 01/25/2021 and Pfizer was given for 2nd dose on 02/22/2021.,Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,OTH,,,,,,"['Interchange of vaccine products', 'No adverse event']",2,PFIZER\BIONTECH,IM 1051803,GA,47.0,F,"unknown, was informed by Health Director that person had passed away",Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/15/2021,7.0,UNK,unknown- not the facility that administered the vaccine,unknown,unknown,,unknown- not the facility that administered the vaccine,['Death'],1,MODERNA,UN 1051822,WA,70.0,F,Pt reports sudden onset of itchy palms. Pt denies any other symptoms. symptoms resolved with no treatment. PT denies Transport.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,OTH,,None,None,,None,['Pruritus'],2,PFIZER\BIONTECH,IM 1051844,,23.0,F,"Reactivation of EBV causing aseptic meningitis with recurrent fevers, bone marrow suppression, liver enzyme elevation",Not Reported,,Not Reported,Yes,7.0,Not Reported,U,02/04/2021,02/11/2021,7.0,PVT,"gabapentin, loratadine, ascorbic acid, cholecalciferol, omeprazole, oxybutynin XL",,"migraines, anxiety",,seasonal allergies,"['Blood immunoglobulin G', 'Blood immunoglobulin M', 'Bone marrow disorder', 'Epstein-Barr virus antibody positive', 'Epstein-Barr virus infection reactivation', 'Hepatic enzyme abnormal', 'Hepatic enzyme increased', 'Meningitis aseptic', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1051859,IL,77.0,M,Received 2nd dose of Moderna on 1/26/2021. Had a hospital visit 2/1/21-2/4/21 for anemia and colitis.,Not Reported,,Not Reported,Yes,4.0,Not Reported,,01/26/2021,02/01/2021,6.0,SEN,,,,,,"['Anaemia', 'Colitis']",2,MODERNA,IM 1051872,CT,73.0,F,"Moderna COVID-19 Vaccine: The morning after injection, she developed shortness of breath, fever, muscle pains, joint pains, delirium. 911 called. EMTs transported her to Hospital where she was admitted after blood tests and CT angiogram of the chest indicated multiple pulmonary emboli in right upper and lower lobes of the lung. Unconscious at the time of admission. Discharged after 3 days. Continues to have significant shortness of breath. Unknown if this will be permanent or lead to death. Reasonably stable at present time although unable to function.",Not Reported,,Yes,Yes,3.0,Not Reported,N,02/17/2021,02/18/2021,1.0,PVT,ASA 81 mg Symbicort Spiriva Amlodipine,None,COPD,,"Latex, sulfa drugs, statins","['Arthralgia', 'Blood test', 'Computerised tomogram thorax', 'Delirium', 'Dyspnoea', 'Echocardiogram normal', 'Fibrin D dimer increased', 'General physical health deterioration', 'Myalgia', 'Pulmonary embolism', 'Pyrexia', 'Ultrasound Doppler']",2,MODERNA,IM 1051873,MN,68.0,F,Lower extremity weakness and rhabdomyolysis,Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/15/2021,02/17/2021,2.0,PVT,"Jardiance, Diflucan, Amaryl, lovastatin, Metformin, metoprolol, Lyrica, spironolactone, sulindac",,"hypertension, diabetes, diabetic neuropathy, DJD",,lisinopril,"['Muscular weakness', 'Rhabdomyolysis']",1,MODERNA,IM 1051911,PA,64.0,F,"Moderna COVID-19 Vaccine: 02/07/2021 Total loss of hearing in right ear and diminished sense of taste. 02/10/2021 Hearing test and prednisone 60mg for 10 days. 02/19/2021: Hearing test Hearing did not improve, but further declined. Blood work, steroid injection into middle ear 02/26/2021: MRI, hearing test",Not Reported,,Not Reported,Not Reported,,Yes,N,01/14/2021,02/07/2021,24.0,PUB,"Keflex, Synthroid, Protonix, Zoloft. Vit B complex, Aspirin 325 mg, Red Yeast Rice, Fiber, Tums",None,Hypothyroid,,None,"['Acoustic stimulation tests abnormal', 'Blood test', 'Deafness unilateral', 'Hypogeusia', 'Magnetic resonance imaging']",1,MODERNA,IM 1051923,,97.0,F,Patient passed away within 60 days of receiving a COVID vaccine,Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,,01/31/2021,02/21/2021,21.0,SEN,,,,,,['Death'],1,MODERNA, 1051942,NY,84.0,M,Hepatorenal syndrome- Death,Yes,02/22/2021,Not Reported,Yes,3.0,Not Reported,N,02/11/2021,02/18/2021,7.0,UNK,"Casodex, Sinemet CR, Plavix, Namenda, Midodrine, Protonix, Crestor, Zoloft, Trazadone,","Acute Hepatitis,","CAD, MI, RLS, Peripheral Neuropathy, PD, hyperlipidemia, orthostatic hypotension, Shy-Drager",,"Intolerance to Morphine, Propoxyphene, Statins, Bisphosphonates, Tramadol, Methadone, and Meperidine","['Autopsy', 'Death', 'Hepatorenal syndrome']",UNK,MODERNA, 1051950,NC,80.0,F,"Angioedema, onset began 8 hrs after vaccination. Did not have adequate response to steroids & antihistamines; required nasotracheal intubation, now with our team in the ICU. Unclear if secondary to vaccine or other cause.",Not Reported,,Yes,Yes,2.0,Not Reported,N,02/23/2021,02/23/2021,0.0,UNK,"Amlodipine, aspirin, B12, Lasix, hydralazine, Isordil, synthroid, cozaar, antivert, simvastatin, sodium bicarbonate tab, warfarin","Reports of a fall, decreased oral intake & nausea a few days prior to vaccination.","Hypertension, hyperlipidemia, membranous glomerulonephropathy, CKD, hypothyroidism.",,Aggrenox - anaphylaxis Lisinopril - cough,"['Angioedema', 'C-reactive protein', 'C1 esterase inhibitor test', 'Endotracheal intubation', 'Intensive care', 'Red blood cell sedimentation rate', 'Tryptase']",UNK,MODERNA, 1051975,,86.0,F,Patient passed away within 60 days of receiving a COVID vaccine,Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,,01/19/2021,02/23/2021,35.0,SEN,,,,,,['Death'],UNK,MODERNA, 1051993,NY,95.0,F,Notified on 2/24/2021 that patient passed away on 2/14/2021. Other cause of death - non-covid -19 related,Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/14/2021,9.0,PVT,,,,,,['Death'],2,PFIZER\BIONTECH, 1052008,TX,83.0,M,"Fever of 101, chills and profound weakness. Patient was unable to ambulate. Patient was admitted due to these symptoms",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/13/2021,02/14/2021,1.0,PVT,"Apixaban, benzonatate, calcium carbonate-vitamin D3, donepezil, gabapentin, lysine, metoprolol succinate, mirabegron, mirtazapine, morphine, multivitamin, ondansetron, pantoprazole, pomalidomide, prochloperazine, tramadol, valacyclovir","C. difficile, possibly pneumonia","Multiple myeloma, GERD, Hypertension, Atrial fibrillation, Alzheimer's disease, Dementia,",,"daratumumab, amlodipine, honey","['Asthenia', 'Chills', 'Clostridium difficile colitis', 'Condition aggravated', 'Gait inability', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1052014,TX,91.0,F,"Extreme difficulty breathing upon exertion, collapsed shortly after walking started, loss of conciousness, and death",Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/15/2021,9.0,OTH,"Digoxin, Levothyroxine, Atorvastatin, Pregabalin, Sertraline, Monteleucast, Tylenol, Aspirin 81 mg,, Vitamin D3, Vitamin C, probiotic, Benadryl",COPD exascerbation' UTI flare-up,"Advanced severe COPD, UTI",,None,"['Death', 'Dyspnoea', 'Loss of consciousness', 'Syncope']",1,PFIZER\BIONTECH,IM 1052020,NY,71.0,M,Acute Myocardial Infarction on 2/16/2021 Patient had a CABG performed on 2/17/2021 Patient is post-surgery - remains hospitalized,Not Reported,,Not Reported,Yes,8.0,Not Reported,Y,01/27/2021,02/16/2021,20.0,PVT,,,Diabetes Hypertension,,,"['Acute myocardial infarction', 'Coronary artery bypass']",1,PFIZER\BIONTECH,IM 1052021,IA,35.0,F,"Anaphylactic Shock. 10 minutes after injection - vomiting, shortness of breath, throat swelling, chest pain. Self-administered EpiPen and went to the ER, given multiple doses of epinephrine, solumedrol, Benadryl, Pepcid. was monitored overnight and sent prednisone and Pepcid.",Not Reported,,Yes,Yes,1.0,Not Reported,N,02/23/2021,02/23/2021,0.0,PVT,,,,,Fish and all seafood,"['Anaphylactic shock', 'Chest pain', 'Dyspnoea', 'Pharyngeal swelling', 'Vomiting']",2,MODERNA,SYR 1052023,CT,70.0,M,"large lower extremity deep venous thrombosis and small pulmonary embolus; outcome: responded well to anti-coagulants, with decreased pain, swelling and improved oxygenation",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/10/2021,02/20/2021,10.0,PVT,"cymbalta, gabapentin, zypraxa, diazepam, quinipril, vitamin D",none,peripheral neuropathy,,none,"['Computerised tomogram thorax', 'Deep vein thrombosis', 'Pain', 'Pulmonary embolism', 'Swelling', 'Ultrasound scan']",2,PFIZER\BIONTECH,SYR 1052045,,85.0,F,Patient passed away with in 60 days of receiving the COVID vaccine series,Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/22/2021,10.0,SEN,,,,,,['Death'],2,MODERNA, 1052049,MN,67.0,M,Patient was into the clinic on the afternoon of 2/23/21 for a COVID-19 vaccine. He had a podiatry clinic visit after his vaccine same day. It was reported by the patients family physician that patient stated he didn't feel well and suddenly collapsed at home at approximately 4:45 pm. Emergency medical personnel were not able to revive him. Patient died at approximately 4:45 pm on 2/23/21.,Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/23/2021,0.0,PVT,Multivitamin and Glucosamine. Started on Prednisone after the vaccine was administered,"None known at the time of the vaccination. However, patient did have a podiatry visit after the vaccination for right foot pain and swelling",None,,None known,"['Death', 'Malaise', 'Pain in extremity', 'Peripheral swelling', 'Syncope']",1,PFIZER\BIONTECH,IM 1052070,NJ,95.0,F,"2/22/2021 10:09 pm resident reported 1 episode of being nauseous and having dry heaves, no temperature, MD notified and nurse was told to continue to monitor, no new orders, daughter made aware. Vital signs being done every 4 hours. 2/23/2021 3:04am resident complains of nausea, scant BM amount x 2, MD notified and no new orders, continue to monitor and encourage fluids, vital signs continue every 4 hours.",Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,SEN,"Aspirin EC tablet delayed release 81mg once a day, Lasix 20mg tablet once a day, Multivitamin once a day, Omeprazole tablet delayed release 20mg once a day, Probiotic Capsule 2 per day, Refresh PM eye ointment at bedtime, Tylenol Extra Str",No,"Acute Diastolic (Congestive) Heart Failure, Bell's Palsy, Essential Hypertension, Unspecified Atrial Fibrillation, Unspecified Macular Degeneration, Atherosclerotic Heart Disease of Native Coronary Artery without Angina Pectoris, Gastro-esophageal Reflux Disease without Esophagitis, Dementia without Behavior Disturbances, Muscle Weakness, Overactive Bladder, H/O Ottis Media, Legal Blindness and Dysphagia",,No known drug or food allergies,"['Infrequent bowel movements', 'Nausea', 'Retching']",2,PFIZER\BIONTECH,IM 1052086,IL,76.0,M,Received1st dose of Moderna on 12/30/2020 and was in the hospital on 1/19/21-1/25/21 for a neck mass.,Not Reported,,Not Reported,Yes,7.0,Not Reported,,12/30/2020,01/19/2021,20.0,SEN,,,,,,['Neck mass'],1,MODERNA,IM 1052095,MI,32.0,F,DVT left lower extremity,Not Reported,,Yes,Not Reported,,Not Reported,N,01/24/2021,02/14/2021,21.0,UNK,"Humira, budensonide, estarylla",None,Ulcerative colitis,,None,"['Deep vein thrombosis', 'Ultrasound Doppler abnormal', 'Ultrasound scan abnormal']",2,MODERNA, 1052098,PA,70.0,M,"Syncope, rash itching",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,02/19/2021,02/20/2021,1.0,UNK,"Synthroid, Avodart, Tylenol, Benadryl, zyrtec, hYZAAR, mULTIVITAMIN, PREDNISONE, Simvastatin",,"Hypothridism, hyperlipidemia",,NKA,"['Rash pruritic', 'Syncope']",UNK,MODERNA, 1052100,GA,79.0,M,"on 1/23, rt became winded and confused, weak and began to require more assistance with ADL's, 1/24/21 acting bizzare, anxious, uncomfortable, increasingly more confused, restless, 1/27 blood noted in urine, SOB and abdominal breathing, was sent to ER - returned with dx of SOB and UTI. 1/29/21 confused and trouble voiding, very restless, 1/30/21 confused and restless, 1/31/21, confused and anxious, 02/02/21, very low heart rate, lethargic, admitted to hospital with cystitis and bradycardia, 2/4/21 returned to facility, 2/11/21 received second dose of Pfazer_ BioNTech vaccine, 2/17/21 very lethargic, bradycardia, 2/21/21 large amount of rectal bleeding, sent to hospital and admitted - remains in the hospital at this time",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/20/2021,01/23/2021,3.0,SEN,"Synthroid, Aspirin, K-Dur, Cozaar, Coreg, Lexapro, Folic Acid, Proair HFA, Augmentin",pneumonia,"hypothyroidism, primary hypertension, CHF, COPD, anemia, CKD",,NKA,"['Abnormal behaviour', 'Anxiety', 'Asthenia', 'Blood urine present', 'Bradycardia', 'Confusional state', 'Cystitis', 'Discomfort', 'Dyspnoea', 'Dysuria', 'Feeling abnormal', 'Heart rate decreased', 'Laboratory test', 'Lethargy', 'Loss of personal independence in daily activities', 'Rectal haemorrhage', 'Restlessness', 'Urinary tract infection']",1,PFIZER\BIONTECH,SYR 1052105,IL,64.0,M,Hypoxia,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/15/2021,02/16/2021,1.0,OTH,,,,,,['Hypoxia'],2,MODERNA,IM 1052106,OR,53.0,F,While at counseling appointment on February 17 patient had witnessed sudden cardiac arrest and was not able to be resuscitated. She was pronounced dead at 12:09. At the time of death her glucose was about 500.,Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/17/2021,6.0,OTH,"Metformin 500 2 tablets bid glipizide 10 mg bid Alopliptan 25 mg daily Prescribed statin, ASA and ace inhibitor but she was not taking them",DM with proteinuria and foot complications hyperlipidemia,DM with proteinuria and foot complications Renal insufficiency hyperlipidemia alcohol abuse,,Augmentin and NSAID,"['Blood cholesterol increased', 'Blood creatinine normal', 'Blood glucose increased', 'Blood potassium normal', 'Blood triglycerides increased', 'Blood urea increased', 'Cardiac arrest', 'Death', 'Low density lipoprotein normal', 'Resuscitation']",1,MODERNA,IM 1052108,,91.0,F,Patient passed away within 60 days of receiving the COVID vaccine series,Yes,02/19/2021,Not Reported,Not Reported,,Not Reported,,01/28/2021,02/19/2021,22.0,SEN,,,,,,['Death'],2,MODERNA, 1052112,OH,67.0,M,Significant increase in tinnitus starting about 10 days after the injection. First observed in right ear and then in the left ear. This is a long time 20 year sufferer of tinnitus. The observation is a very significant change in the level experienced. Concerned about having the second injection and impact it would have on quality of life if this does not subside.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/10/2021,02/21/2021,11.0,PVT,"Plavix, lisinopril, rosveristatin, fish oil, vit D, multi vitamin",None,"Tinnitus, back pain",,None,"['Condition aggravated', 'Tinnitus']",1,MODERNA,SYR 1052121,NY,76.0,M,"loose stools, encephalopathy",Not Reported,,Not Reported,Yes,,Not Reported,U,02/19/2021,02/20/2021,1.0,UNK,Medication Dose/Rte/Freq Days Qty Entered Last Max Daily Dose Reviewed Simvastatin- (Zocor-) 20 MG PO QHS 04/22/16 02/21/21 Strength: 20 MG TAB 1254 1605 Ondansetron HCl- (Zofran-) 1 TAB PO 30 06/17/19 02/21/21 Strength:,,cirrhosis,,Adhesives Unknown 02/21/21 Atenolol (From TENORMIN) Unknown BRADYCARDIA 02/21/21 Cholestyramine (From Unknown INTOLERANCE 02/21/21 QUESTRAN) Diltiazem (From CARDIZEM Unknown RASH/HIVES 02/21/21 CD) Disopyramide (From Unknown SINUS PAUSES 02/21/21 NORPACE) Lansoprazole (From Unknown INTOLERANCE 02/21/21 PREVACID) Omeprazole (From PRILOSEC) Unknown CONSTIPATION 02/21/21 Warfarin and Related,"['Diarrhoea', 'Encephalopathy']",UNK,MODERNA, 1052138,IL,72.0,M,Received Moderna 1st dose on 12/29/2020. Was in the hospital on 1/17/21-1/21/21 for severe hypotension and removal and replacement of hemodialysis shunt.,Not Reported,,Not Reported,Yes,5.0,Not Reported,,12/29/2020,01/17/2021,19.0,SEN,,,,,,"['Arteriovenous fistula operation', 'Haemodialysis', 'Hypotension']",1,MODERNA,IM 1052164,TN,78.0,M,"911 called to patients house for trouble breathing and abdominal pain. Patient coded, wife presented DNR paperwork. Patient presented to Hospital DOA at 0958.",Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/24/2021,1.0,PVT,,,Stage 4 Kidney Disease Hypertension Ischemic Bowel Hyperlipidemia GERD CAD,,,"['Abdominal pain', 'Cardio-respiratory arrest', 'Death', 'Dyspnoea']",UNK,MODERNA,IM 1052172,MI,55.0,M,"Agency contacted 2/19 In evening by employer representative- client Died Suddenly after work""",Yes,02/19/2021,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,PUB,unknown,unknown,unknown,,statins- stated no allergic reaction but can't take,"['Autopsy', 'Death', 'Sudden death']",1,MODERNA,IM 1052179,,77.0,M,Patient passed away within 60 days of receiving a COVID vaccine,Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,,01/25/2021,02/21/2021,27.0,SEN,,,,,,['Death'],1,MODERNA, 1052203,NY,77.0,F,"the patient had hypoxemia the evening of the shot, and then was found unresponsive the next morning, in cardiac arrest at home. Temperature on arrival to ED was 91 degrees. found to have severe anoxic brain injury after 60+ minutes of CPR. may already be brain dead.",Not Reported,,Yes,Yes,1.0,Yes,N,02/23/2021,02/24/2021,1.0,OTH,"warfarin, losartan, lisinopril, metoprolol, hydrochlorothiazide",,breast cancer,,blueberries,"['Aspartate aminotransferase increased', 'Blood lactic acid', 'Brain death', 'Brain injury', 'Cardiac arrest', 'Hypoxia', 'Ischaemic hepatitis', 'Resuscitation', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 1052217,CA,81.0,M,"Elevated heart rate, flushing of the face and ears, vomiting, trouble breathing, pulmonary edema",Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,PVT,"metoprolol, eliquis, diltiazem",none,"diabetes, arterial fibrillation",,none,"['Dyspnoea', 'Flushing', 'Heart rate increased', 'Pulmonary oedema', 'Vomiting']",1,PFIZER\BIONTECH,SYR 1052226,MS,62.0,M,"Patient discovered unresponsive in cell, blue coloration to skin, vital signs, undetectable. CPR initiated, Ambulance summoned. Following EMS arrival with additional unsuccessful attempts to revive patient, patient was determined to have expired.",Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/13/2021,2.0,OTH,"Alveso, Xopenex, Aspirin, Atorvastatin, Cetirizine, Fiber, Hydralazine, Hydrochlorothiazide, Levothyroxine, Lisinopril, Meloxicam, Metformin, Metoprolol, Novolin,",,"Arthritis, Diabetes Mellitus, Diabetic Neuropathy, Venous Insufficiency in Lower Extremity, Hypothyroidism, Chronic Obstructive Pulmonary Disease, Hypothyroidism, Obesity",,Bactrim,"['Cyanosis', 'Death', 'Resuscitation', 'Unresponsive to stimuli']",1,MODERNA,IM 1052242,CA,79.0,M,"Patient reported as being altered, GCS 6 with noted aphasia around 1415.",Not Reported,,Not Reported,Yes,5.0,Yes,U,02/19/2021,02/19/2021,0.0,PVT,Atenolol 25mg qDay; Celexa 20mg qDay; Depakote 250mg TID; Donepezil 10mg qDay; Memantine 10mg BID; Simvastatin 40mg qDay; Trazadone 50 TID with meals,None aware of,"Afib, COPD, CKD II, Pacemaker, previous CVA, high cholesterol, high BP",,None,"['Aphasia', 'Cerebrovascular accident', 'Coma scale abnormal', 'Computerised tomogram abnormal', 'Mental status changes', 'Mood altered', 'Thrombosis']",1,PFIZER\BIONTECH,SYR 1052261,MA,58.0,M,"Nausea, vomiting, diarrhea for 4 days. Nausea and vomiting resolved but diarrhea continues to be an issue, although improved.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/19/2021,02/20/2021,1.0,OTH,"Amlodipine, Aspirin, Atorvastatin, Calcitriol, Citalopram, Doxazosin, Losartan, Metoprolol, Pantoprazole, Prednisone, Tacrolimus","Episode of nausea, vomiting, diarrhea related to mispositioned peritoneal dialysis catheter on 2/1/21","non-ischemia cardiomyopathy with orthotopic heart transplant, hyperlipidemia, end stage renal disease on peritoneal dialysis, glucorticoid-induced osteoporosis, lumbar spondylosis, degenerative joint disease, erectile dysfunction, slow urinary stream,","Shingrix, age 58, fever and nausea for 24 hours with symptoms resolving by 48 hours",Ampicillin Penicillin V,"['Diarrhoea', 'Nausea', 'SARS-CoV-2 test negative', 'Stool analysis', 'Vomiting']",2,PFIZER\BIONTECH,IM 1052273,,77.0,M,Patient admitted to the hospital the day after receiving a COVID vaccine x 5 days. Patient passed away on 2/23/2021.,Yes,02/23/2021,Not Reported,Yes,5.0,Not Reported,,01/26/2021,01/27/2021,1.0,SEN,,,,,,['Death'],1,MODERNA, 1052300,,88.0,F,"PATIENT ON 2ND DAY AFTER VACCINATION COULD NOT STAND OR WALK, COULD NOT UNDERSTAND COMMANDS OR CUES, COULD NOT FEED HERSELF, PRIOR TO VACCINATION AMBULATORY AND FEEDING HERSELF.",Not Reported,,Not Reported,Yes,5.0,Yes,,01/20/2021,01/22/2021,2.0,UNK,"LEVOTHYROXINE 75 MCG, LEXAPRO 5 MG, KCL 10 MG, METFORMIN ER 500MG, VITAMIN C 500 MG, ZINC 220 MG, METOPROLOL 50 MG, NAMENDA 10 MG, ASPIRIN 81 MG, SIMASTATIN 40 MG, TYLENOL 500 MG","UTI, ADVANCED MEMORY LOSE, TYPE 2 DIABETES, ANXIETY",,,"SULFA ANTIBIOTICS, NSAIDS","['Communication disorder', 'Dysstasia', 'Feeding disorder', 'Gait inability', 'Loss of personal independence in daily activities']",1,PFIZER\BIONTECH,IM 1052370,TX,72.0,M,"50 % loss of movement in the right side of his body (arm and leg); lost the physical ability in the right arm and the right leg; can't walk without assistance; lost fifty percent movement on right side in his arm and leg. It is not hurting. It is weak; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269), via an unspecified route of administration on 07Feb2021 08:30 at a single dose on left arm for COVID-19 immunization. Medical history included high blood pressure, enlarged prostate, and COPD (chronic obstructive pulmonary disease). Ongoing concomitant medications included lisinopril, and tamsulosin hydrochloride (TAMSULOSIN). The patent was taking unspecified concomitant medications. The patient previously received flu shot months ago for immunization. The patient did not receive any vaccine 4 weeks prior to COVID vaccine. The patient was administered Pfizer COVID19 vaccination on this past Sunday, 07Feb2021. He was feeling alright on Sunday. On Monday (08Feb2021) when he woke up, he had lost fifty percent movement on right side in his arm and leg. It is not hurting. It is weak. He had lost the physical ability in the right arm and the right leg. The shot was given in left arm. He said he still has it and he can't walk without assistance. The events did not require a visit to the emergency room or to the physician office. He is scheduled to get the next shot on 04Mar2021 at 3:30PM. The patient has not recovered from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/08/2021,1.0,UNK,LISINOPRIL; TAMSULOSIN [TAMSULOSIN HYDROCHLORIDE],,Medical History/Concurrent Conditions: Blood pressure high; COPD; Enlarged prostate,,,"['Gait disturbance', 'Hemiplegia', 'Movement disorder', 'Muscular weakness']",1,PFIZER\BIONTECH, 1052371,NC,50.0,F,"Bell's Palsy; This is a spontaneous report from a contactable healthcare professional. A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiry date: unknown), via an unspecified route of administration on 21Jan2021 (at the age of 50 years old) at a single dose for covid-19 immunization. Medical history included hypertension, gastrooesophageal reflux disease (GERD), obesity, and allergies: sulfa. Concomitant medications included hctz, escitalopram oxalate (LEXAPRO), losartan, metoprolol and omeprazole (PROTONIX [OMEPRAZOLE]). The patient is not pregnant. The patient had no other vaccine in four weeks and was not tested for covid post vaccination. On 09Feb2021, the patient experienced Bell's palsy. Therapeutic measures were taken as a result of the event Bell's palsy included prednisone and valacyclovir. Outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,02/09/2021,19.0,PVT,HCTZ; LEXAPRO; LOSARTAN; METOPROLOL; PROTONIX [OMEPRAZOLE],,Medical History/Concurrent Conditions: GERD; Hypertension; Obesity; Sulfonamide allergy,,,['Facial paralysis'],1,PFIZER\BIONTECH, 1052372,MS,57.0,F,"The roof of my mouth shedded (was raw) and bleed for a few days; The roof of my mouth shedded (was raw) and bleed for a few days; I felt like I was having a heart attack; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), intramuscularly on 29Jan2021 at 09:30 AM at a single dose for COVID-19 immunisation. The patient's medical history included asthma and known allergies to medication. Concomitant medications included paracetamol (TYLENOL) and metoprolol, which were reported as medications in two weeks. It was reported that other vaccines in four weeks were prescribed. On 31Jan2021 at 09:00 AM, the patient experienced the roof of her mouth shedded (was raw) and bled for a few days. A few days later (2021), she felt like she was having a heart attack. There was no treatment for the events. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The outcome of the events was recovered on 2021. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event myocardial infarction cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/31/2021,2.0,UNK,TYLENOL; METOPROLOL,,Medical History/Concurrent Conditions: Asthma; Drug allergy,,,"['Mouth haemorrhage', 'Myocardial infarction', 'Oral mucosal exfoliation']",1,PFIZER\BIONTECH,OT 1052373,PA,38.0,M,"Blood clot on lung after experiencing chest pain; This is a spontaneous report from a contactable consumer reported for himself. A 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 14:00 on Arm left at single dose (Lot # EK9231) for covid-19 immunisation. Prior to vaccination, was the patient did not diagnose with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient with confirmed blood clot on lung after experiencing chest pain/chest tightness/left sided, thought that he was having a heart attack, shortness of breath on 03Feb2021, reported as non serious. Emergency room/department or urgent care. Blood thinner received for the events. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,02/03/2021,11.0,PUB,,,,,,['Pulmonary thrombosis'],1,PFIZER\BIONTECH, 1052374,MO,44.0,F,"pancreatitis; This is a spontaneous report from a contactable Physician. A 44-years-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on arm left on 21Jan2021 07:00 at SINGLE DOSE for covid-19 immunisation. Medical history included migraines and seasonal allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), montelukast sodium (SINGULAIR), norethisterone (ORTHO MICRONOR) and topiramate (TOPAMAX). The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Dec2020 on left arm for covid-19 immunisation (age at vaccination: 44 years). The patient experienced pancreatitis, moderate mid-epigastric pain and elevated enzymes on 28Jan2021 18:00. The patient underwent lab tests and procedures which included enzymes: elevated on Jan2021 and labs: unknown result on an unspecified date. Therapeutic measures were taken as a result of pancreatitis, abdominal pain upper and elevated enzymes. Outcome of the events was recovered on Feb2021.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported pancreatitis with symptoms of moderate mid-epigastric pain and elevated enzymes and the administration of the COVID-19 vaccine, BNT162B2, considering the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/28/2021,7.0,PVT,ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SINGULAIR; ORTHO MICRONOR; TOPAMAX,,Medical History/Concurrent Conditions: Migraine; Seasonal allergy,,,"['Enzyme level test', 'Investigation', 'Pancreatitis']",2,PFIZER\BIONTECH, 1052375,KY,82.0,F,"sometimes the pain in her neck affects her ear and swallowing; sometimes the pain in her neck affects her ear and swallowing; it was shooting pain up into her skull and the top of her head; neck pain on the left side; her skin on the left side of her neck is sore to touch; This is a spontaneous report from a contactable nurse (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269, expiration date was not reported) (at 82 years of age), via an unspecified route of administration in the left arm on 06Feb2021 15:40 at a single dose for COVID-19 immunisation. Medical history included diabetes mellitus and hypertension. There were no concomitant medications. The patient did not take any other vaccinations within four weeks prior to the first administration date of the vaccine. She had no adverse events prior vaccinations and no illness at time of vaccination. The patient received her 1st dose on Saturday (06Feb2021). On Sunday (07Feb2021), she had neck pain on the left side, which was the same as she got the vaccine, and it was shooting pain up into her skull and the top of her head. She stated that her skin on the left side of her neck was sore to touch on 07Feb2021. Sometimes it affects her ear and swallowing on 09Feb2021. She stated that he looked in her throat and it looked okay. She wanted to know if this was from the vaccine. She stated that the shooting pain was killing her today. She had been using Bengay, heat, and Tylenol which lasts about 8hrs. States that the pain woke her up last night, so she took 2 Tylenol Arthritis. Her 2nd dose of the vaccine is scheduled for 27Feb2021. Her husband kept saying it was from the shot, but she doesn't know. She asked if it was then what is she going to do with the 2nd one? The patient did not go to the emergency room nor visit a physician's office for the events. The outcome of the event neck pain was not recovered while recovering for other events. The events neck pain on the left side, skin on the left side of her neck is sore to touch, and sometimes the pain in her neck affects her ear and swallowing are reported as medically significant events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/07/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Diabetes; Hypertension,,,"['Dysphagia', 'Ear disorder', 'Headache', 'Neck pain', 'Pain of skin']",1,PFIZER\BIONTECH, 1052376,CA,61.0,F,"Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location/vaccination location: arm left) on 29Jan2021 13:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included bad back, penicillin allergy, and covid prior vaccination all from unknown dates and unknown if ongoing. The patient has not had other vaccine in four weeks. Patient was not pregnant. Concomitant medication included oxycodone hydrochloride (OXYCONTIN). The patient experienced extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues (all events assessed as serious - disability) all on 05Feb2021 17:00. Patient's clinical course is as follows: One week after the shot, patient had extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues then continued for 2 more days. No treatment was provided for the events. It was reported that patient was COVID tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with result of negative on 20Jan2021. Facility type vaccine was reported as nursing home. Outcome of the events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/29/2021,02/05/2021,7.0,SEN,OXYCONTIN,,Medical History/Concurrent Conditions: Back pain; COVID-19; Penicillin allergy,,,"['Abdominal pain upper', 'Dehydration', 'Fatigue', 'Movement disorder', 'SARS-CoV-2 test', 'Speech disorder']",1,PFIZER\BIONTECH, 1052401,NC,41.0,M,"Dose 2 of Covid vaccine given 2/18/2021, on 2/19/2021 felt bad, stayed in bed all day and that evening had a sharp pain in chest. chest pain continued intermittent next day and then 2/22/2021 0200 it was a sharp crudhing pain that radiate down his L arm, same arm had the vaccine in, awoke him from sleep",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/18/2021,02/19/2021,1.0,MIL,"ascrobic acid, famotidine, omeprazole",,IBS-D and GERD,,No known allergies,"['Catheterisation cardiac', 'Chest pain', 'Feeling abnormal', 'Insomnia', 'Mobility decreased', 'Pain', 'Sleep disorder', 'Troponin increased']",2,PFIZER\BIONTECH, 1052450,TX,30.0,F,"Patient was experiencing rash and chills after her second dose of COVID19 vaccine, treated herself with benadryl to resolve. Rash re-appeared following day, presented to the ED received solumedrol, fluids and benadryl, and she was discharged with ranitidine and hydroxyzine (2/21). She returned on 2/23 to ED, presented with rash, tachycardia and c/o abdominal pain . She was treated with methylprednisolone 15mg, 1L of LR, 1L of NS, and 50 mg IV diphenhydramine, 0.3 mg IM Epinephrine, and 20 mg of famotidine IVx1. Patient was continued on prednisone 40 mg po bid and famotidine 20mg po bid.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/20/2021,02/20/2021,0.0,PUB,None,,,,NKA,"['Abdominal pain', 'Chills', 'Eosinophil percentage decreased', 'Rash', 'Tachycardia', 'Ultrasound abdomen', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 1052456,ID,62.0,F,"2/3/21: c/o Fever, headache and vomiting; 2/3/21 at 7am: Fever escalated; 2/4/21: Temp: 104; admitted to hospital; Dx: HSV-1, Encephalitis; Tx: Acyclovir IV TID x 3 weeks, completes tx on 2/25/21 Admitted total of 6 days 2/10/21: discharged home, continues to have difficulty with computation of numbers and naming objects",Not Reported,,Not Reported,Yes,,Not Reported,N,01/23/2021,02/03/2021,11.0,UNK,"trazodone, vit-d, omeprazole, Methylfolate, lexapro",none,"anxiety, MTHR deficiency, trigeminial neuralgia",,Azelox,"['Communication disorder', 'Computerised tomogram abdomen', 'Computerised tomogram pelvis', 'Encephalitis', 'Headache', 'Laboratory test', 'Lumbar puncture', 'Mental status changes', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 1052461,PA,69.0,M,"Severe chest pain, upper back/shoulder pain, fatigue?? dx. Acute Myocardial Infarction? angioplasty with stent",Not Reported,,Yes,Yes,3.0,Not Reported,Y,02/16/2021,02/18/2021,2.0,PVT,,,Diabetes,,Tetracycline,"['Acute myocardial infarction', 'Angioplasty', 'Arthralgia', 'Back pain', 'Catheterisation cardiac', 'Chest pain', 'Fatigue', 'Myocardial necrosis marker increased', 'Stent placement']",1,MODERNA,IM 1052478,IA,96.0,F,Patient presented to the emergency department after being found down in her home and presented with right upper and lower extremity weakness and a right-sided facial droop. Patient's presentation was consistent with an acute ischemic stroke which was confirmed on MRI.,Not Reported,,Yes,Yes,,Yes,N,02/22/2021,02/23/2021,1.0,PUB,,,,,,"['Facial paralysis', 'Ischaemic stroke', 'Magnetic resonance imaging brain abnormal', 'Muscular weakness']",1,MODERNA,IM 1052491,NC,67.0,M,"brain fog immediately after vaccination, 2 hours later blood pressure and heart were elevated. Around 11:00 pm went into extreme Atrial Fibrillation and risk of stroke for 10 hours. Heart rate went from 55 bpm before vaccine to 90 bpm after vaccine. Blood pressure went from 120/70 to 145/80.",Not Reported,,Yes,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PVT,"Losartin, coQ10",none,"treated, controlled high blood pressure",,none,"['Atrial fibrillation', 'Blood pressure increased', 'Cerebrovascular accident', 'Electrocardiogram', 'Electrocardiogram ambulatory', 'Feeling abnormal', 'Heart rate increased', 'Immediate post-injection reaction']",1,PFIZER\BIONTECH,IM 1052494,,58.0,F,"Moderna dose 2 received at 1605. Patient reported funny taste and throat tightness. Oral diphenhydramine liquid 25mg was given. Tongue swelling and mild stridor were noted, prompting administration of an epinephrine pen and EMS was called. SpO2 noted to be in high 70s, along with persistent symptoms, so she was given an additional epinephrine pen as well as 100mg IM hydrocortisone. She was started on a 15L non-rebreather mask, IV was placed in the left antecubital space, and intubation kit was pulled from cart. Tongue and stridor improved after these doses of epinephrine and hydrocortisone. Blood pressure 190s systolic from 170s systolic after first epinephrine dose, with HR 116 at this point, and SpO2 99%. As EMS arrived, diphenhydramine 25mg IV was administered. At that point, tongue size and stridor were noted to have worsened again, so a third epinephrine pen was administered prior to EMS transport. Patient received racemic epinephrine inhalation nebulizer in EMS. Further treatment administered in ED: LR, dexamethasone and famotidine. Patient admitted later that day for further monitoring given hypertensive status. Put on scheduled cetirizine, famotidine, and dexamethasone and PRN albuterol and racemic epinephrine. Throughout her stay, patient continued to improve with stable vital signs and normal breathing. She was monitored for a total of 2 days and discharged home on 1/29.",Not Reported,,Not Reported,Yes,2.0,Not Reported,,01/27/2021,01/27/2021,0.0,PVT,,,"Bipolar disorder, ADHD, GERD, panic disorder, and borderline intellectual ability",,,"['Hypertension', 'Stridor', 'Swollen tongue', 'Taste disorder', 'Throat tightness']",2,MODERNA,IM 1052496,MD,71.0,F,"Numbness and tingling on right side of body, onset < 24 hours after vaccine was administered. Equilibrium affected. Treated at hospital ER and admitted. Acute ischemic VBA thalamic stroke.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/14/2021,02/15/2021,1.0,PHM,"Amlopidine 2.5 mg, multi-vitamin, fish oil, calcium, strontium, digestive enzymes, ubiquinol , querciplex, DGL, Vitamin D3, Zinc, Buffered Vitamin C",None,"Diverticulosis, recurring diverticulitis, microscopic colitis, osteoporosis.",,"Allergic to pencillins, erythromycin, tetracycline, levaquin, dextromethorphan. No food allergies","['Echocardiogram', 'Electrocardiogram', 'Full blood count', 'Hypoaesthesia', 'Ischaemic stroke', 'Lipids', 'Magnetic resonance imaging', 'Paraesthesia', 'Ultrasound Doppler', 'Vertebrobasilar stroke']",1,MODERNA,IM 1052521,FL,20.0,M,"20 year old with cerebral palsy, chronic bronchitis, G-tube dependent received COVID 19 vaccine approximately 1030 on 2/18. Within 5 minutes c/o headache and had audible wheezing. He was treated with Benadryl in the vaccine clinic. He was taken to ER noted to be in resp distress. He received IM epinephrine and symptoms quickly improved. Less than an hour later was again noted to be wheezing and in respiratory distress. He was treated with second IM epinephrine, albuterol, steroids, and antihistamines. Admitted into PICU overnight and remained asymptomatic. Patient received the pneumococcal and influenza vaccines 3 days prior. Has never had any similar reactions in the past. Patient was discharged on 2/19.21.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,02/18/2021,02/18/2021,0.0,PVT,montelukast; lactulose,None,"Cerebral Palsy, GDD, Gtube dependent and chronic bronchitis",,"Chocolate, Dust, Peanuts","['Headache', 'Intensive care', 'Respiratory distress', 'Wheezing']",1,PFIZER\BIONTECH,IM 1052523,NM,26.0,M,"Pt recived his second Moderna vaccine 2/15/21, and on 2/16, staff at pt's group home noted pt was unable to walk although pt previously ambulatory (could go on long hikes prior to acute illness). Pt was grabbing his legs and rubbing them, and initially staff thought it was pain that would resolve. However, on 2/22, lower extremity edema was noted, and pt without improving symptoms, so he was brought to the hospital for evaluation and treatment. GBS suspected, IVIG initiated.",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,02/15/2021,02/16/2021,1.0,UNK,"Aripiprazole 15 mg daily, clonidine 0.1 mg QHS, diazepam 10 mg BID, divalproex 1000 mg PO BID, fluphenazine 10 mg AHS",None other than chronic conditions,"Autism with intermittent explosive disorder, seasonal allergies",,NKDA,"['CSF glucose decreased', 'Gait inability', 'Guillain-Barre syndrome', 'Immunoglobulin therapy', 'Oedema peripheral', 'Protein total increased', 'White blood cell count increased']",2,MODERNA, 1052540,NH,36.0,F,"1/6 vaccination 1/7 typical immune system response; recovered in 12 hours. 1/8 Woke up and my left hand was weak, numb and tingling in glove distribution. The right hand started to have problems as evening came. The right hand resolved within 12 hours. The left hand symptoms persisted for 6 weeks. *unable to work for 6 weeks. **Still having symptoms in middle finger, pointer finger; left hand. 1/8 I went to urgent care; referred to ED. They did put me in the clinical observation unit, discharged the next day. I went to PCM 2 days later. Dr. didn't know what to think of symptoms. Had me try some steroids. Hospital referred me to neurology; He had me do another MRI (1st in the ER). EMG. He didn't find anything unusual except some nerve damage; carpal tunnel *Symptoms are still persisting. It has gotten better but the 2 fingers are still an issue.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/06/2021,01/08/2021,2.0,PVT,Zoloft,,depression & anxiety,,,"['Blood test', 'Carpal tunnel syndrome', 'Electromyogram', 'Hypoaesthesia', 'Immune system disorder', 'Impaired work ability', 'Magnetic resonance imaging', 'Muscular weakness', 'Nerve injury', 'Paraesthesia']",2,PFIZER\BIONTECH,SYR 1052549,TN,71.0,M,"Tongue and lip swelling on one side (left) and throat closure, admitted to ER then ICU 2/17/2021. Discharged from ICU on 2/19/2021.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,02/17/2021,02/17/2021,0.0,PVT,Metoprolol 25mg QD Metronidazole 250mg QD Wixela Inhub Diskus 250/50mcg BID Gabapentin 600mg TID Cilostazol 100mg BID Lisinopril 40mg QD Citalopram 40mg QD Fenofibrate 145mg QD Atorvastin 80mg QD Amlodipine 10mg QD Famotidine 40mg QD Aspi,None,"COPD, CHF, Peripheral Artery Disease, GERD",,Bee stings,"['Intensive care', 'Laboratory test', 'Lip swelling', 'Swollen tongue', 'Throat tightness']",UNK,MODERNA,IM 1052550,KY,80.0,M,"fever, ongoing fatigue, cough, bilateral LE edema, loss of taste and smell",Not Reported,,Not Reported,Yes,,Not Reported,,01/25/2021,02/04/2021,10.0,UNK,,,,,,"['Ageusia', 'Anosmia', 'Cough', 'Fatigue', 'Oedema peripheral', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1052571,MN,84.0,M,"Resident came up to staff and approximately 1400 and said, ""I have a fever"" - temperature was assessed and was 98.4 resident came back several minutes later and stated again, ""I have a fever"" - temperature assessed again and was 98.2 - staff asked if resident had his window open, he stated no - staff suggested maybe he open up his window because it is quite warm in the building at this time. Resident said ok - went back into room - staff told writer he had c/o ""I have a fever"" while staff was in change of shift report and they assessed fever and it was 97.1. Around 1525, Resident noted to have sudden SOB. PRN albuterol neb given. RR before neb was 40 and did not improve. BP 136/66, pulse 158, temp 101.7 tympanic, and O2 sats 76% RA. Placed on supplemental O2 and sat came up to 86% on 3 L. Resident then started to complain of chest pain. Resident was weak and unsteady and insisted on standing but was guided to his chair to sit down. Resident said he wished to go to ER and daughter in agreement. 911 called. Writer assisting with transferring resident out to hospital. While waiting for ambulance, patient restless and visibly short of breath. Lips with blue discoloration, pale appearance, and breathing with accessory muscles. Changing positions frequently from lying to sitting and standing due to being uncomfortable. Temp 103.2 in left hear and 102.5 in right ear. Respirations 36. Blood pressure unable to be checked due to restlessness and moving around. Pulse 167. O2 92% with nasal cannula on 3L. Asked him to point to the pain and he pointed to his upper abdomen, but describes it as chest pain. Per EMTs he is being sent to clinic instead of the other clinic due to abnormal EKG readings. Received update from EMT around 1700 that patient arrived to ER and heart attack was confirmed so patient was being sent to cath lab for angioplasty procedure.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/23/2021,02/23/2021,0.0,PHM,"Spiriva Respimat Aerosol Solution 1.25 MCG/ACT (Tiotropium Bromide Monohydrate), Levothyroxine Sodium Tablet 25 MCG, Divalproex Sodium Capsule Delayed Release Sprinkle 125 MG, Aspir-Low Tablet Delayed Release 81 MG (Aspirin), rOPINIRole HCl",,"UNSPECIFIED DEMENTIA , UNSPECIFIED OSTEOARTHRITIS, HX COVID-19, HX PNEUMONIA, DYSPHAGIA, GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS, BENIGN PROSTATIC HYPERPLASIA WITHOUT LOWER URINARY TRACT SYMPTOMS, HYPERTROPHY OF BREAST, PURE HYPERCHOLESTEROLEMIA, ESSENTIAL (PRIMARY) HYPERTENSION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE WITH (ACUTE) EXACERBATION, HYPOTHYROIDISM, TYPE 2 DIABETES MELLITUS WITHOUT COMPLICATIONS",,Lactose Intolerant,"['Abdominal pain upper', 'Asthenia', 'Balance disorder', 'Body temperature increased', 'Chest pain', 'Cyanosis', 'Dyspnoea', 'Electrocardiogram abnormal', 'Myocardial infarction', 'Pallor', 'Pyrexia', 'Restlessness', 'Use of accessory respiratory muscles']",2,MODERNA, 1052579,MO,61.0,M,"Moderna COVID 19 vaccine ADR. Approximately 14 hours after receiving the vaccine on 01/29/21 the patient starting experiencing extreme confusion, shaking, and then subsequently fell. EMS was called and was taken by ambulance to Hospital where he was admitted for 6 days. I called up follow up 02/16/21 and he still reports a daily persistent headache that migrates around the circumference of his head.",Not Reported,,Not Reported,Yes,6.0,Not Reported,U,01/29/2021,01/30/2021,1.0,PVT,,,,,,"['Confusional state', 'Fall', 'Headache', 'Tremor']",UNK,MODERNA,IM 1052585,MN,82.0,M,"Severe stabbing heart pain. Called 911. In hospital 2/19 thru 2/22. Chest x-ray, EKG, and ultrasound indicated no heart attack and heart looked good. Doctor stated ordeal was result of 2nd dose of vaccine. Person had previously suffered with Covid and was hospitalized from 10/26/20 thru 11/5/2020",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,02/18/2021,02/19/2021,1.0,UNK,"300 mg Allopurinol, 81 mg aspirin, 10 mg Atorvastatin, 500 mg Cephalexin, 75 mg Clopidogrel, 50 mg Metoprolol tartrate, Vitamin B complex, Preservision Areds 2 PO",Aneurysm in groin with partial blockage,Same,,"Penicillin, Iodine","['Angina pectoris', 'Chest X-ray normal', 'Echocardiogram normal', 'Electrocardiogram normal', 'Ultrasound scan normal']",2,PFIZER\BIONTECH,SYR 1052645,IL,77.0,F,"Cardiogenic shock occurred on 2/10/2021, approximately 12 hours after patient received her 12th dose of pemetrexed/pembrolizumab and 4 days after COVID vaccine. Coronary angiography was done on 2/10/2021 and no significant coronary narrowing or blockage were noted. Baseline troponin on 2/10/21 was 0.02 and later on 2/10/21, troponins were 9.99 & 25.27. Creatinine increase from 1.2 to 3.4 within 24hours, and AST/ALT increased from 23 & 31 to 4,220 & 4,786 respectively on 2/11. Patient expired on 02/11/2021.",Yes,02/11/2021,Not Reported,Yes,2.0,Not Reported,N,02/06/2021,02/10/2021,4.0,PVT,"prednisone, Armour thyroid, folic acid, cholecalciferol, coenzyme Q 10, tumeric pemetrexed/pembrolizumab - 12 doses, last dose o 02/09/2021",Stage IV adenocarcinoma of lung,Stage IV adenocarcinoma of lung diagnosed on 05/19/2020,,"Latex, penicillin, sertraline","['Alanine aminotransferase increased', 'Angiocardiogram', 'Arteriogram carotid normal', 'Aspartate aminotransferase increased', 'Blood creatinine increased', 'Cardiogenic shock', 'Death', 'Troponin increased']",UNK,PFIZER\BIONTECH, 1052662,IN,65.0,M,Went to pcp two hours after vaccine. EKG given and was told by my doctor I was in AFIB and needed to go to the ER immediately. Spent a couple hours in the ER and then admitted for six days. I am still in AFIB,Not Reported,,Yes,Yes,6.0,Yes,N,02/17/2021,02/17/2021,0.0,PUB,None,None,Aorta dissection repair March 2019,,None,"['Atrial fibrillation', 'Electrocardiogram']",1,MODERNA,SYR 1052700,TN,71.0,M,71 year old male patient recived the Moderna vaccine on 12/28/2020 and 1/27/2021. Tested positive for Covd-19 on 2/1/2021 (aysmptomatic). Passed away on 2/23/2021. Report came from facility.,Yes,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/01/2021,5.0,SEN,Unknown,"COPD, Essential hypertension","COPD, Essential hypertension",,"Aspirin, Bee Stings, Bupropion","['COVID-19', 'Death', 'SARS-CoV-2 test positive']",2,MODERNA,IM 1052702,CA,74.0,F,"Shortness of breath, pressure on my chest, high blood pressure after 10 days of getting covid 19 vaccine",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,02/10/2021,02/20/2021,10.0,PHM,"Lisinopril 20 mg, Hydroxychloroquine 200mg, Aspirin 85 mg. , Vit. C , Folic acid, Iron, Ca. citrate with Zn and Vit. D, Osteo Bi-flex, colace",,"Lupus, HTN, high cholesterol, arthritis",,"Clindamycin, Amoxicillin, Cipro, Protonix, Motrin","['Angiogram', 'Body temperature increased', 'Cardiac stress test', 'Chest X-ray', 'Chest discomfort', 'Computerised tomogram', 'Dyspnoea', 'Echocardiogram', 'Electrocardiogram', 'Hypertension', 'Laboratory test']",1,MODERNA,IM 1052705,WA,27.0,F,GBS strongly suspected Patient received dose #2 of Moderna COVID vaccine on 02/12/21. She had a low grade fever and lower extremity aches that evening. The morning of 02/13 she began experiencing tingling in her bilateral toes. She presented to the emergency department 02/17 because this lack of sensation continued to progress until she had no sensation to her mid thigh and began to be unable to feel her perianal region. Her fingertips also started to go numb. She also reported some diplopia. Received IVIG Somewhat improved strength and sensation on discharge. Discharged to inpatient rehabilitation facility,Not Reported,,Yes,Yes,7.0,Not Reported,N,02/12/2021,02/13/2021,1.0,PVT,Adderall 10mg BID Omeprazole 20mg every morning before breakfast,,ADD Migraines GERD hx gastric sleeve (08/2020),,"honey bee venom--anaphylaxis ""TB test solution""","['Anal hypoaesthesia', 'Asthenia', 'CSF cell count normal', 'CSF test normal', 'Diplopia', 'Electromyogram abnormal', 'Guillain-Barre syndrome', 'Hypoaesthesia', 'Immunoglobulin therapy', 'Lumbar puncture normal', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging spinal normal', 'Pain in extremity', 'Paraesthesia', 'Protein total normal', 'Pyrexia', 'Sensory loss']",1,MODERNA,IM 1052707,CA,31.0,M,"Chief Complaint fever and chills, body aches x 3 days. also complains of intemrittent chest pain since yesterday 02/20/21 10:28 History of Present Illness This is 31 year old male with no significant past medical history. Patient is health care provider and working in surgical center. Patient ha COVID 19 second dose of vaccination on Wednesday and he was feeling sick after that including fever, chills and tiredness. He had chest pain started Thursday and which is in left side of the chest and mostly constant in nature and intensity was up and down and highest intensity was 7/10. No aggravating and relieving factor, denied any shortness of breath, leg swelling. He visited to urgent care and had 12 lead EKG and which showed ST changes in inferior lead and transfer to hospital ER. He is currently having pain about 1/10 intensity. He denied any nausea, vomiting, urinary and bowel symptoms. (sic) Assessment/Plan Chest pain with elevated troponin NSTEMI vs myocarditis post COVID 19 vaccination",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/17/2021,02/18/2021,1.0,PVT,none,,,,NKA,"['C-reactive protein', 'Cardiac telemetry', 'Chest pain', 'Chills', 'Deep vein thrombosis', 'Echocardiogram', 'Electrocardiogram ST segment abnormal', 'Fatigue', 'Gastrointestinal disorder prophylaxis', 'Malaise', 'Pain', 'Pyrexia', 'Red blood cell sedimentation rate', 'Troponin increased']",2,MODERNA,IM 1052711,WI,92.0,F,"The patient has developed an acute deep venous thrombosis in the right popliteal and trifurcation vessels of the calf. She has an elevated d-dimer of 14,738 and acute hypoxic respiratory failure due to pulmonary embolism.",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/27/2021,02/24/2021,28.0,PVT,"Tylenol, celexa, benadryl, ceterizine, metoprolol succinate, mirtazipine, potassium, prednisone, probiotic, torsemide, diclofenac topical, aspirin EC 81mg, ferrous gluconate, levothyroxine,","Atrial fibrillation, chronic, rate controlled, on aspirin Congestive heart failure, with preserved EF, valvular disease GERD Insomnia Hypertension Hypothyroidism Gout, on chronic prednisone","Atrial fibrillation, chronic, rate controlled, on aspirin Congestive heart failure, with preserved EF, valvular disease GERD Insomnia Hypertension Hypothyroidism Gout, on chronic prednisone",,No known allergies,"['Deep vein thrombosis', 'Fibrin D dimer increased', 'Pulmonary embolism', 'Respiratory failure', 'Ultrasound scan abnormal']",1,PFIZER\BIONTECH,SYR 1052724,NY,82.0,M,"Moderna COVID- 19 Vaccine EUA: one day after vaccination patient reported increasing fatigue after flying on an airplane to a high altitude destination. Two days after vaccination patient fell out of bed overnight and awoke confused with a temperature of 104 degrees Fahrenheit. Patient was transferred to another hospital by ambulance, admitted, received antibiotics, but developed acute hypoxemic respiratory failure. Eight days after vaccination patient transferred to intensive care unit at current hospital with acute respiratory distress syndome and bilateral pulmonary infiltrates requiring intubation and mechanical ventillation three days after arrival. Patient remains in the intensive care unit receiving antimicrobials and steroids.",Not Reported,,Yes,Yes,13.0,Not Reported,N,02/11/2021,02/13/2021,2.0,UNK,"vitamin C, aspirin, atorvastatin, calcium, vitamin D3, cod liver oil, cyanocobalamin, guaifenesin, losartan, magnesium, multivitamin, omeprazole, zinc",None reported,"hypertension, vocal cord anomaly, transient ischemic attack, obesity",,None reported,"['Acute respiratory distress syndrome', 'Antineutrophil cytoplasmic antibody negative', 'Antinuclear antibody negative', 'Aortic arteriosclerosis', 'Blood beta-D-glucan normal', 'Blood lactate dehydrogenase increased', 'Body temperature increased', 'Cardiac septal hypertrophy', 'Chest X-ray abnormal', 'Complement factor C3', 'Complement factor C4', 'Computerised tomogram thorax', 'Confusional state', 'Diastolic dysfunction', 'Echocardiogram', 'Echocardiogram abnormal', 'Electrocardiogram P wave biphasic', 'Endotracheal intubation', 'Fall', 'Fatigue', 'Fibrin D dimer increased', 'Fungal test negative', 'Glycosylated haemoglobin increased', 'Haemoglobin decreased', 'Herpes simplex test negative', 'Hyperdynamic left ventricle', 'Intensive care', 'Left atrial enlargement', 'Legionella test', 'Lung infiltration', 'Lung opacity', 'Mechanical ventilation', 'Mitral valve incompetence', 'Pleural effusion', 'Procalcitonin', 'Pulmonary hypertension', 'Respiratory failure', 'Rheumatoid factor negative', 'SARS-CoV-2 test negative', 'Serum ferritin increased', 'Sleep disorder', 'Streptococcus test negative', 'Tricuspid valve incompetence', 'Ultrasound Doppler normal']",2,MODERNA, 1052738,VA,95.0,M,"He vaccine on 2/5/2021 I went to see my husband the next day he was shaking and his mouth was open shaking, and he had fever of 105, they gave him Tylenol suppositories and he passed away 2 hours later. They should not have given him should not have given him the vaccine that is on hospice, it was not the right decision. I am worried about the elderly and those very sick.",Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,,02/05/2021,02/06/2021,1.0,SEN,he takes prescriptions,no,CHF,,no,"['Death', 'Pyrexia', 'Tremor']",2,MODERNA,IM 1052742,CA,68.0,M,"Patient c/o of weakness, malaise, body aches 2 days after receiving Pfizer vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,,02/18/2021,02/18/2021,0.0,PVT,,,,,,"['Asthenia', 'Axonal and demyelinating polyneuropathy', 'Guillain-Barre syndrome', 'Malaise', 'Nerve conduction studies abnormal', 'Pain']",UNK,PFIZER\BIONTECH, 1052747,OH,74.0,F,"Patient presented to hospital with increasing SOB, dyspnea on 2/22/21 (vaccine dose on 2/9/21). Patient is still currently admitted to monitor respiratory status and has been diagnosed with unilateral diaphragmatic paralysis.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/09/2021,02/22/2021,13.0,UNK,"Atorvastatin 40mg daily, levothyroxine 62.5mcg daily, lorazepam 0.5mg BID prn anxiety (rarely used)",No active illnesses prior to vaccination,Hypothyroidism,,"No known allergies to food, drug, or otherwise","['Angiogram pulmonary normal', 'Atelectasis', 'Atrial fibrillation', 'Brain natriuretic peptide normal', 'Chest X-ray abnormal', 'Diaphragmatic paralysis', 'Differential white blood cell count normal', 'Dyspnoea', 'Laboratory test normal', 'Magnetic resonance imaging spinal', 'Pleural effusion', 'Procalcitonin normal', 'SARS-CoV-2 test negative', 'Troponin', 'White blood cell count normal']",1,PFIZER\BIONTECH,IM 1052774,WI,85.0,F,"The patient has developed an acute ischemic stroke on the evening of receiving the COVID vaccine #1 dose. She is in the hospital with left sided weakness, facial droop and speech changes. She is receiving blood thinner and therapies.",Not Reported,,Yes,Yes,2.0,Not Reported,N,02/22/2021,02/22/2021,0.0,PVT,"Amlodipine, calcium carbonate, cetirizine, vitamin D3, fish oil, latanoprost ophthalmic solution, losartan, metoprolol succinate, multivitamin, saline nasal spray, timolol 0.5% ophthalmic gel",Osteoporosis Hypertension DJD Glaucoma vasomotor rhinitis Paroxysmal supraventricular tachycardia History of mycobacterium avium lung infection/ colonization Prediabetes,Osteoporosis Hypertension DJD Glaucoma vasomotor rhinitis Paroxysmal supraventricular tachycardia History of mycobacterium avium lung infection/ colonization Prediabetes,,No known allergies,"['Cerebral infarction', 'Facial paralysis', 'Hemiparesis', 'Ischaemic stroke', 'Magnetic resonance imaging brain abnormal', 'Speech disorder']",1,MODERNA,SYR 1052787,IL,43.0,F,"""Received 2nd Covid vaccination have had headaches, earaches, tachycardia, and SOB since vaccination"" TM was hospitalized 3xs after vaccination. On 1/24/21 TM was hospitalized and kept overnight for tachycardia and SOB and has to f/u with cardiology this week. The second time TM went to the hospital for a headache where an MRI was done. The third time she was also treated for a headache",Not Reported,,Not Reported,Yes,,Not Reported,U,01/10/2021,01/10/2021,0.0,PVT,,,,,,"['Dyspnoea', 'Ear pain', 'Headache', 'Magnetic resonance imaging brain', 'Tachycardia']",2,PFIZER\BIONTECH,IM 1052809,CA,73.0,M,Patient passed away,Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,PVT,"Neurontin, Proscar, Glucophage XR, Norvasc, Glucotrol, Lasix, Lipitor, Cozaar, Hygroton, Protonix, Hytrin",Pressure ulcers,"BPF, CAD, Essential HTN, Diverticulosis of colon, Hyperlipidemia, Osteoarthritis, chronic respiratory failure, DM2 with peripheral vascular disease, peripheral edema, GERD, obstructive sleep apnea, osteoarthritis of knees,",,Lisinopril,['Death'],UNK,MODERNA,IM 1052820,OH,73.0,F,"Approximately 2 weeks after the first COVID vaccine she developed shortness of breath that was much more significant than she had previously. This was the first time she had expressed this symptom to me as being something she was concerned about and difficult for her to manage (we have spoken almost daily for many years). Within 24 hours of the second dose of the mRNA vaccine, they called an ambulance to get her and she was taken to the hospital and diagnosed with bacterial pneumonia. The doctors said it was unrelated, but I found a study with a different vaccine (LAIV) that also seemed to increase the incidence of bacterial pneumonia. They hypothesized through diverting the immune system. So while I don't think the vaccine gave her the bacteria, I do think it may have caused her immune system to be temporarily compromised allowing the bacteria to grow out of control. I feel this is important to report to look for these types of patterns as perhaps it can help others avoid the death spiral that happened to my mother. There were also intervening events between her hospitalization and her death including two successful surgeries (one for a broken hip and another to put in stents in her leg). So to summarize, the first vaccine was within about 2 weeks of the onset of her breathing problems. Within 24 hours of the second vaccine she was hospitalized and diagnosed with bacterial pneumonia. As she was battling bacterial pneumonia in the hospital she broke her hip and was found to have reduced peripheral circulation and had 2 surgeries to correct those. They were successful according to the surgeons, however she died within a week or so of the surgeries. She had other comorbidities as well which I'm sure predisposed her such as diabetes, hypertension and cancer for many years.",Yes,02/19/2021,Yes,Yes,18.0,Not Reported,N,01/25/2021,01/26/2021,1.0,SEN,"A variety of medications for diabetes, blood circulation, hypertension","Diabetes, hypertension, cancer (lung)",cancer for many years.,Breathing issues ~2 weeks after first dose of mRNA vaccine in the series but were not nearly as acute or severe as they were fol,none,"['Death', 'Dyspnoea', 'Hip fracture', 'Hip surgery', 'Pneumonia bacterial', 'Poor peripheral circulation', 'Stent placement', 'Surgery']",UNK,MODERNA, 1052829,OH,44.0,M,"Fever, fatigue, low grade fever, swollen lymph node in arm pit and neck. Heart SVT, rapid heart beat 48 hours later",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/17/2021,02/17/2021,0.0,PVT,"Vitamin c, elderberry, prilosec, allegra",No,No,,Tetracycline,"['Echocardiogram', 'Electrocardiogram', 'Fatigue', 'Heart rate increased', 'Lymphadenopathy', 'Pyrexia', 'Supraventricular tachycardia']",1,MODERNA,SYR 1052840,MI,85.0,M,"DIRECTLY FOLLOWING ADMINISTRATION Involuntary shaking in both arms for 2-3 hrs (severe). Not just trembles Fatigue to near incapacitation (severe) Muscular movement unresponsive Unable to stand, sit up right, raise arms Incontinence Confusion, non-responsive, fog 101.3 F temperature Strained breathing",Not Reported,,Yes,Yes,3.0,Not Reported,N,02/20/2021,02/20/2021,0.0,PVT,"Diltiazem CD, Finasteride, Lisinopril, Terazosin, Hydrochlorothiazid, Allopurinol, Asprin",,Hypertension (controlled),,None,"['Arrhythmia', 'Body temperature increased', 'Bradycardia', 'Chest X-ray', 'Confusional state', 'Dyskinesia', 'Dyspnoea', 'Dysstasia', 'Echocardiogram', 'Fatigue', 'Feeling abnormal', 'Full blood count', 'Immediate post-injection reaction', 'Incontinence', 'Laboratory test', 'Mobility decreased', 'Muscle disorder', 'Posture abnormal', 'Tremor', 'Ultrasound Doppler', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 1052844,CO,80.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA: five days after vaccination patient presented to emergency department with left-sided facial droop, right gaze preference, and left hemi-paresis. Patient diagnosed with right middle cerebral artery occlusion, likely thrombotic etiology, admitted to hospital, and underwent thrombectomy and recanalization with symptom improvement. Discharged to home improved, stable, with vital signs within normal ranges two days after arrival to emergency department.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/13/2021,02/18/2021,5.0,PVT,"vitamin D3, famotidine, alendronate, amlodipine, aspirin, atorvasatin, calcium, diclofenac gel, duloxetine, lidocaine patch, multivitamins",None reported,"hyperlipidemia, hypertesnion, vitamin D deficiency, hypothyroidism, obesity, hearing loss, gastric ulcer, gastroesophegeal reflux disease, ovarian cyst, renal cyst, back pain, osteoporosis, hypertension",,"losartan-hydrochlorothiazide, amoxicillin","['Angiogram cerebral normal', 'Aortic arteriosclerosis', 'Arteriogram carotid normal', 'Blood cholesterol decreased', 'Blood electrolytes normal', 'Blood glucose normal', 'Carbon dioxide decreased', 'Cerebral artery occlusion', 'Cerebral infarction', 'Echocardiogram abnormal', 'Facial paralysis', 'Full blood count normal', 'Gaze palsy', 'Hemiparesis', 'High density lipoprotein normal', 'International normalised ratio normal', 'LDL/HDL ratio decreased', 'Low density lipoprotein normal', 'Magnetic resonance imaging brain abnormal', 'Prothrombin time normal', 'Thrombectomy', 'Thrombosis', 'Venous recanalisation']",1,PFIZER\BIONTECH,IM 1052848,,87.0,M,"Patient received both doses of Pfizer vaccine. Patient reports around 5 days after the vaccine, experienced shortness of breath, generalized weakness. On admission (about 10 days after completion of vaccination), patient is diagnosed covid-19 pneumonia with covid pcr positive and chest x ray consistent with pneumonia.",Not Reported,,Not Reported,Yes,,Not Reported,,02/01/2021,02/01/2021,0.0,UNK,,,,,,"['Asthenia', 'COVID-19', 'COVID-19 pneumonia', 'Chest X-ray abnormal', 'Dyspnoea', 'Pneumonia', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1052880,PA,84.0,F,"11PM CHILLS,TEETH CHATTERING, BODY SHAKING, NAUSEA. APPROX 2-3 AM 2/18/21 ON WAY TO THE BATHROOM LOSS OF CONSCIOUNESS-FELL HIT HEAD, PASSED OUT 2 X MORE. PARAMEDICS CALLED ADMITTED TO HOSPITAL EEG, CAT SCAN, NO FEVER, CHILLS 4-5AM SWEATING PROFUSLY, LOW BP, POSTURAL HYPOTENSION, DISCHARGE FRIDAY 2/19/2021 . SATURDAY 2/20/2021 HIGH BP > 170. BP CURRENTLY UNSTABLE HIGH AND LOW",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/17/2021,02/24/2021,7.0,PHM,"SERTRALINE, PRENISOLONE EYE DROPS, AMLODIPINE/BENAZAPRIL, PRAVASTATIN, SYNTHROID, AEREDS2, VIT D 2000U, VALCYCLOVIR 500",,"HBP, HYPOTHYROID,DYSLIPIDEMIA,IBS",,"SULFA, PENICILLIN, IBUPROFEN","['Blood pressure abnormal', 'Chills', 'Computerised tomogram', 'Electroencephalogram', 'Fall', 'Head injury', 'Hyperhidrosis', 'Loss of consciousness', 'Nausea', 'Orthostatic hypotension', 'Somnolence', 'Tremor']",2,MODERNA,IM 1052944,WV,77.0,M,"11/24/2021 Began with indigestion, chest discomfort and slight arm pain. then on 11/26/2021 symptoms worsened. Admitted to medical center for cath and stint placement.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,01/08/2021,01/24/2021,16.0,OTH,none,none,COPD,,allergic to penicillin causes hives,"['Chest discomfort', 'Condition aggravated', 'Dyspepsia', 'Myocardial infarction', 'Pain in extremity', 'Stent placement']",2,PFIZER\BIONTECH,IM 1052950,AR,74.0,M,"Extreme weakness, constipation, decreased appetite. Shortness of breath with activity. How many living in to Atrial Fibrillation and heart failure.",Not Reported,,Not Reported,Yes,29.0,Not Reported,N,01/07/2021,01/08/2021,1.0,PVT,Diclofenac Photonics Valsartan HCT Cardezam Cd Vitamin C Vitamin D Zinc sulfate Actos Lipitor Neto form in,Noel. Cce,Diabetes Hypertension Osteo arthritis,,No,"['Acute kidney injury', 'Asthenia', 'Atrial fibrillation', 'Cardiac failure', 'Cardiac failure congestive', 'Chest X-ray abnormal', 'Constipation', 'Decreased appetite', 'Dyspnoea']",2,PFIZER\BIONTECH,IM 1052972,MO,87.0,F,RESIDENT EXPIRED,Yes,,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/23/2021,0.0,SEN,NO,NO,"ACUTE KIDNEY DISEASE, DIABETES, HYPERTENSIVE HEART",,NO,['Death'],2,MODERNA,SC 1052979,NJ,69.0,F,"pain neck shoulders head, dehydration, electrolytes, elevated heart rate, vomiting, fever",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,02/02/2021,02/04/2021,2.0,OTH,Kolonipin Lamotrigine Bupropion Lipitor Lipitor,none,,,Penicillin,"['Arthralgia', 'Blood electrolytes', 'Computerised tomogram', 'Dehydration', 'Electrocardiogram', 'Headache', 'Heart rate increased', 'Neck pain', 'Pyrexia', 'Scan brain', 'Vomiting']",UNK,MODERNA, 1052990,TX,73.0,F,"Likely not be related directly to vaccine adverse event other than Fatigue and sleepiness reported 2/22/2021. Patient missed her clinic appointment and we called in to check in with her. She had no other symptoms. She rescheduled her appointment to come in for her clinic visit to Tuesday, 2/23/2021 but did not arrive. We could not contact her thereafter on Tuesday. We were able to reach her medical power of attorney on Wednesday morning who with the help of EMS was able to enter her home. We do not know what other symptoms patient was experiencing. We also had the major winter storm between 2/11 /2021 and 2/19/2021. This affected are elderly severely. Unclear what utility she had or how she managed. On 2/20/2021 patient had only come in for her Covid vaccine appeared tired on that day but most of was struggling through the winter storm and not recovered yet. Patient was found deceased by her friend and officer who assisted her to enter patient's house. Unknown time or circumstances of patient demise.",Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/22/2021,2.0,PVT,"gabapentin, levothyroxine, iron, vitamin D3, Protonix, vitamin B12, Tylenol as needed, Claritin as needed, Anoro inhaler, albuterol inhaler, IV Zometa every 3 months, Herceptin every 3 weeks, Perjeta every 3 weeks, Faslodex monthly and Ibra","Metastatic breast cancer on treatment with, severe arthritis of hip, peripheral neuropathy, recent winter storm with loss of utilities unknown how much she was affected as she lives alone without family nearby","Peptic ulcer disease, bone metastasis, hypothyroidism, degenerative joint disease,",,NKDA,"['Death', 'Fatigue', 'Somnolence']",2,UNKNOWN MANUFACTURER,IM 1053016,FL,72.0,F,"Patient developed intense abdominal cramping, nausea, and rapid heart rate (101) as well as high blood pressure (158/88). EMS was called and one dose of EpiPen was given in the left thigh. the patient was then taken to a nearby hospital by EMS.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/24/2021,02/24/2021,0.0,PHM,Unknown,Unknown,High Chloesterol,,No,"['Abdominal pain', 'Heart rate increased', 'Hypertension', 'Nausea']",2,MODERNA,IM 1053084,TX,68.0,M,VAC WAS NOT GIVEN IN THIS CLINIC PT WAS TREATED AFTER SURGERY PT RECIVED THE FIRST ROUND 12/23/20 AND SEC ROUIND 1/20/2021 THEN 7 DAYS POST VAC PT SUFFERED FROM A SUBDURAL HEMATOMA .,Not Reported,,Not Reported,Yes,5.0,Not Reported,U,01/20/2021,01/20/2021,0.0,PVT,UNKNOWN,NO NONE ILLNESSES AT TIME,UNKNOWN,,NO KNOWN ALLERGIES,['Subdural haematoma'],UNK,MODERNA, 1053087,CO,82.0,F,"right arm cellulitis. had to be hospitalized due to tachycardia, fever, clinical exam consistent with cellulitis",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/17/2021,02/18/2021,1.0,PVT,"? Mirtazapine (REMERON) 15 mg Oral Tab Take one-half tablet by mouth at bedtime as needed 45 tablet 3 ? Cyanocobalamin (VITAMIN B-12) 1,000 mcg Oral Tab Take 1 tablet by mouth daily for B12 deficiency 100 tablet PRN ? Lisinopril (PRINIVIL/Z",none,HTN hx of breast cancer,,PCN,"['Cellulitis', 'Pyrexia', 'Tachycardia']",2,MODERNA,IM 1053176,IN,65.0,M,"severe reaction within 48 hours of the vaccine , sent to the hospital with uncontrollable bleeding, in ICU with thrombocytopenia",Not Reported,,Yes,Not Reported,,Not Reported,U,02/08/2021,02/10/2021,2.0,SEN,,,"GERD, COPD, type 2 diabetes",,,"['Haemorrhage', 'Intensive care', 'Reaction to preservatives', 'Thrombocytopenia']",1,MODERNA,IM 1053191,IN,67.0,F,"Vaccine administered 02/08/2021 , by Thursday 02/11/2021 patient almost nonverbal, by Monday 02/15/2021 patient went to the hospital with bruising, sores on her stomach and clots reported as thrombocytopenia, deceased by Friday 02/19/2021.",Yes,02/19/2021,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/11/2021,3.0,SEN,,,,,,"['Aphasia', 'Communication disorder', 'Contusion', 'Death', 'Thrombocytopenia', 'Thrombosis']",1,MODERNA,IM 1053200,CA,76.0,F,"Within 1-2 days of second COVID vaccine, patient developed ataxic gait. After ~7-10days of symptoms, she saw her primary care, who referred the patient to the ER for stroke work-up. MRI of the brain with and without gadolinium contrast showed sub-CM lesions. Pan-CT scan showed no evidence of malignancy. LP for CSF analysis shows lymphocytic pleocytosis. Complete axonal MRI of the spine (cervical, thoracic and lumbar) shows T2 cord signal abnormalities concerning for demyelinating process. Overall, highly concerning for COVID mRNA vaccine induced acute disseminated encephalomyelitis (ADEM). Treatment initiated with glucocorticoids.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,02/12/2021,02/14/2021,2.0,PVT,Alendronate. Cholecalciferol. Levothyroxine.,,Hypothyroidism. Osteoporosis. Dyslipidemia.,,Sulfmethaxole,"['Acute disseminated encephalomyelitis', 'Ataxia', 'CSF cell count', 'CSF test abnormal', 'Magnetic resonance imaging brain abnormal', 'Pleocytosis', 'Red blood cell count decreased']",UNK,PFIZER\BIONTECH, 1053202,TX,86.0,M,GI BLEED,Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/12/2021,02/15/2021,3.0,PVT,UNKNOWN,UNKNOWN,UNKNOWN,,UNKNOWN,"['Full blood count', 'Gastrointestinal haemorrhage', 'Metabolic function test']",UNK,MODERNA, 1053222,CA,82.0,F,"headache, chills, fever, palpitations found to have NSVT, A Fib with RVR and hypomagnesemia",Not Reported,,Not Reported,Yes,2.0,Not Reported,,02/23/2021,02/23/2021,0.0,PVT,"losartan, doxazosin, metoprolol, aspirin",None,"HTN/HLD, DMII, TIA, SSS s/p Medtronic PPM, CAD s/p CABG to RCA and LAD s/p PCI x 2 to LCx (2011), CKD stage 3, urinary incontinence and GERD",,"Morphine, amlodipine,","['Atrial fibrillation', 'Blood creatine phosphokinase', 'Blood magnesium decreased', 'Chills', 'Electrocardiogram', 'Electrocardiogram abnormal', 'Headache', 'Hypomagnesaemia', 'Palpitations', 'Pyrexia', 'Troponin increased', 'Ventricular tachycardia']",UNK,MODERNA, 1053227,TN,86.0,F,"2.12-fever, flu-like symptoms, confusion and disorientation 2.15 - resident presented with extreme confusion and weakness in arms and legs. unable to do usual daily activities. unable to self-transfer. Taken to ER and diagnosed with UTI. 2.18 - resident complained of headache and being unable to sleep previous night. VS: temp 101.8; BP:135/63; P:93; R:20; SP02:79-80%; HOB elevated. Resident send to ER via ambulance. Diagnosed with pneumonia. hospitalized for 5 days.",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,02/11/2021,02/12/2021,1.0,SEN,amlodipine lantus letrozole levothyroxine cetirizine escitalopram pantoprazole tresiba melatonin donepezil cerovite metamucil vitamin D3 janumet carvedilol irbesartan tobramycin diclofenac gabatenin humalog lorazepam polyethelene glycol,,blind DMII HTN hypothyroidism osteoporosis breast cancer double mastectomy GERD chronic depression IBS CAD paraxysmal A-Fib,,penicillins tramadol,"['Body temperature increased', 'Confusional state', 'Disorientation', 'Headache', 'Influenza like illness', 'Loss of personal independence in daily activities', 'Muscular weakness', 'Pneumonia', 'Pyrexia', 'Sleep disorder', 'Urinary tract infection']",2,MODERNA,IM 1053233,SC,94.0,M,tonic clonic seizure hospitalized for observation,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/22/2021,02/23/2021,1.0,PVT,q HS afluzocin prn TUMS slow iron,,Barrett's esophogus,,PCN nexium,"['Blood test normal', 'Computerised tomogram head', 'Computerised tomogram head normal', 'Computerised tomogram neck', 'Computerised tomogram normal', 'Generalised tonic-clonic seizure']",2,PFIZER\BIONTECH,IM 1053274,AK,34.0,F,"thrombocytopenia, ITP",Not Reported,,Yes,Yes,1.0,Not Reported,N,02/12/2021,02/21/2021,9.0,PVT,daily MV,none,none,,none,"['C-reactive protein normal', 'Full blood count', 'Immune thrombocytopenia', 'International normalised ratio normal', 'Metabolic function test normal', 'Platelet count decreased', 'Prothrombin time normal', 'Thrombocytopenia']",1,MODERNA,IM 1053279,,70.0,M,"Patient suffered severe short term memory loss starting at 7am on 2/3 and continuing until approximately 7pm on 2/3. Patient was stuck in a 2 minute or less loop for the entirety of the day. Patient went to ER and was checked into hospital overnight for monitoring. While patient MAY have taken a fall and suffered a concussion, MRI and CT scans showed nothing confirming this or any other indications of what was causing the short term memory loss.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/01/2021,02/03/2021,2.0,UNK,Activated charcoal,None,None,,None,"['Amnesia', 'Computerised tomogram normal', 'Magnetic resonance imaging normal']",2,MODERNA,IM 1053292,,22.0,M,Patient developed severe abdominal pain Sunday night and was admitted to the hospital for treatment of acute pancreatitis.,Not Reported,,Not Reported,Yes,,Not Reported,N,02/20/2021,02/21/2021,1.0,MIL,,,,,,"['Abdominal pain', 'Lipase increased', 'Pancreatitis acute']",2,MODERNA,IM 1053296,,58.0,F,Left upper extremity DVT and pulmonary embolism diagnosed 2/24/2021. Arm swelling started 02/23/2021.,Not Reported,,Not Reported,Yes,,Not Reported,N,02/05/2021,02/23/2021,18.0,WRK,none,none,none,,none,"['Angiogram', 'Computerised tomogram thorax', 'Deep vein thrombosis', 'Peripheral swelling', 'Pulmonary embolism', 'Ultrasound scan abnormal']",UNK,PFIZER\BIONTECH, 1053306,WA,53.0,F,Within 8 hours of second vaccine I began having symptoms of autoimmune reactivity years under control. It started with hives and oral angioedema I was able to quell with some on hand steroids and high does Benadryl - I am an ARNP . This went on for a few weeks until a critical time on 2/19/2021 when a full flare was uncontrollable affecting my airway I was not able to stop the ongoing immunity as it built up over the 2 weeks. My temporary measures could not keep it at bay. I was emergently taken to ER trauma bay and aggressively treated with Epi 0.3 IM x 2 high dose solumedrol x 3 125 mg and 60 mg IV and 50 mg Benadryl IV X3 Pepcid IV X1 then admitted to telemetry for severity overnight,Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/29/2021,01/29/2021,0.0,WRK,"T3 T4 Turmeric Triazolam sleep Telmasartan - now stopped, didn't really need it, angioedema risk +",Hashimoto Dx formally in 2016 likely much longer,"Autoimmune disease characterized in past 1998-2004 as polyarteritis nodosa AND forming IGE anti-bodies to IgE receptor (+ autologous serum challenge) - to control it required plasmapheresis x9, IV Ig monthly for 6 months 1.5g/kg (3 rounds in 4 years, 18 x) and weekly IM methotrexate and H1 blockade daily for CIU All under very good control many years no meds until this vaccine geared up system. Hashimotos also is chronic. Some flares. Some data late 90s links CIU to Hashimotos. Insomnia.",,Compazine- dystonic Amitriptyline - rash Ampicillin - anaphylaxis,"['Angioedema', 'Autoimmune disorder', 'Blood test', 'Cardiac telemetry', 'Condition aggravated', 'Obstructive airways disorder', 'Urticaria']",2,MODERNA,IM 1053311,LA,69.0,M,"The patient was admitted for recurrent syncope that began on Friday evening 2/19. He fell twice and struck his head, knocking 2 teeth loose. He continued to feel lightheaded the next day and came to the ED and was admitted for syncope workup. His workup was negative. On discharge, patient recalled that he received his 1st Covid vaccine. His symptoms resolved after admission. This event was likely related to his vaccination.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/18/2021,02/20/2021,2.0,PUB,,,,,NKA,"['Dizziness', 'Fall', 'Head injury', 'Loose tooth', 'Syncope']",1,MODERNA,IM 1053322,MO,76.0,F,Pt had passed away before second dose,Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/31/2021,33.0,MIL,,,,,,['Death'],UNK,MODERNA,IM 1053346,IL,66.0,F,Hemorrhagic Stroke,Not Reported,,Yes,Yes,,Not Reported,N,02/22/2021,02/22/2021,0.0,OTH,,,,,,['Haemorrhagic stroke'],2,MODERNA,SYR 1053348,TX,75.0,F,ITP,Not Reported,,Yes,Yes,1.0,Not Reported,N,02/17/2021,02/18/2021,1.0,PVT,LEVOTHYROXINE OLMESARTAN,NONE,"VERY EARLY STAGE MDS, HYPOTHYROIDISM, HYPERTENSION.",,NKDA,"['Immune thrombocytopenia', 'Platelet count decreased']",2,MODERNA,IM 1053367,NM,52.0,M,day after vaccination suffered from a massive cerebellar stroke with ischemic infarct and suspected embolic stroke required emergency craniectomy with cerebellar resection,Not Reported,,Yes,Yes,,Not Reported,N,02/19/2021,02/20/2021,1.0,UNK,lisinopril HCTZ Ambien as needed Ativan as needed ibuprofen as needed,no known,Hypertension,,no known,"['Brain operation', 'Cerebellar stroke', 'Computerised tomogram head', 'Craniectomy', 'Embolic stroke', 'Ischaemic cerebral infarction', 'Magnetic resonance imaging brain']",UNK,PFIZER\BIONTECH, 1053378,WI,51.0,F,"Patient presented on 2/24/21 with B pulmonary emboli, with symptoms of dyspnea started around 2/22/2021, she was have headache, dizziness and abdominal bloating on presentation.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/17/2021,02/22/2021,5.0,PVT,"atenolol, citalopram, acetaminophen, B complex vitamins, black cohosh, cholecalciferol and fluticasone",none,"class 3 obesity, hx of previous unprovoked PE, HT, depression, PCOS",,none,"['Abdominal distension', 'Computerised tomogram thorax abnormal', 'Condition aggravated', 'Dizziness', 'Dyspnoea', 'Headache', 'Pulmonary embolism']",2,MODERNA,SYR 1053386,CA,84.0,F,"Hearing loss, auditory hallucinations",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/20/2021,02/12/2021,23.0,PVT,Aspirin 81 Carvedilol,,Paroxysmal atrial fibrillation Hyperlipidemia DM,,Contrast dye,"['Blood thyroid stimulating hormone', 'Deafness', 'Hallucination, auditory', 'Magnetic resonance imaging brain normal']",2,PFIZER\BIONTECH,IM 1053393,NM,76.0,M,"Patient felt achy, tired starting the day after the vaccine. Per his wife, he was very tired and ""losing stamina"". On 2/13/21, he woke up feeling dizzy and weak. His wife asked him if he wanted to go to the doctor and he declined. He ate breakfast and went to rest in his easy chair. He passed away an hour later.",Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,PUB,,,cardiovascular disease smoker,,,"['Asthenia', 'Death', 'Dizziness', 'Fatigue', 'Malaise', 'Pain']",1,PFIZER\BIONTECH,IM 1053682,WY,83.0,M,"Stroke. I do not know if the vaccine was related or not, but the patient had a stroke and falls on 2/17/2021 and 2/18/2021 and was found to have two strokes. He does have atrial fibrillation, but with the proximity to the second vaccine, I cannot tell if they are just related temporally or if there is a true risk. Another patient at this facility had a stroke within same time frame post second Moderna vaccine, but not my patient, so I do not know if that was reported. Due to new nature of this vaccine, I felt it important to report this event for further investigation. Again, I am not sure if it is a true adverse reaction of the vaccine or not.",Not Reported,,Not Reported,Yes,6.0,Yes,U,02/11/2021,02/18/2021,7.0,PVT,"jardiance, flomax, eliquis, atovorvastatin, plavix, glimeprimide, metoprolol, digoxin, tramadol, glucosamine-chondroitin, potassium, and lasix",no acute illness,"atrial fibrillation, diabetes mellitus, osteoarthritis.",,no known drug allergies,"['Basal ganglia stroke', 'Cerebrovascular accident', 'Fall', 'Magnetic resonance imaging brain abnormal']",2,MODERNA,IM 1060528,,95.0,M,"Death due to underlying condition for hospice pt. Narrative: This was a 95 yo patient residing at home with daughter. Patient reported to PCP on 1/4 c/o poor appetite and weight loss. Daughter reported that patient was very frail and requested a hospice referral. Outside medical records indicate that patient was dx with pneumatosis of the cecum and peritonitis. Patient also had severe atherosclerotic disease with near complete occlusion of the infrarenal abdominal aorta. Due to age and frailty, patient was placed in hospice care where he passed away on 1/22/21.",Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/22/2021,8.0,OTH,,,,,,['Death'],1,PFIZER\BIONTECH, 1053571,FL,28.0,F,"Jaw pain; Syncopal episode/Syncope; Fell; Dizziness; Nausea; Felt flu-like; Injection site pain; Fatigue; Headache; Muscle pain; Chills; Fever; Felt unwell; A spontaneous report was received from a nurse concerning a female 28 year old, patient who experienced same day injection site pain, fatigue, headache, muscle pain, chills, fever, felt unwell and flu-like. On 29/Jan/2021, she developed dizziness, nausea, a syncopal episode and fell and hit her jaw, which developed into pain. . The patient's medical history was not provided. Concomitant product use was unknown by the reporter. The patient received their second dose of mRNA-1273 lot 028L20A on 28-JAN-2021. On 28-JAN-2021 approximately 1 day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 Lot number 028L20A intramuscularly for prophylaxis of COVID-19 infection. A patient received her second dose of Moderna vaccine on 28/Jan/2021 at 8 AM, lot 028L20A. Same day at 17:00, she experienced injection site pain, fatigue, headache, muscle pain, chills, fever, felt unwell and flu-like. On 29/Jan/2021, she developed dizziness, nausea, a syncopal episode and fell and hit her jaw, which developed pain. She was seen in the emergency room (ER) and released with a diagnosis of syncope and jaw pain. Resolution dates not reported. Treatment information was not provided/unknown. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.; Reporter's Comments: This report concerns a 28--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # not provided, and within 2 days, experienced injection site pain, fatigue, headache, muscle pain, chills, fever, felt unwell and flu-like, dizziness, nausea, a syncopal episode and fell and hit her jaw, which developed into pain. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: MOD21-024340:Crosslinked: Same Reporter MOD21-024360:Crosslinked: Same Reporter MOD21-024368:Crosslinked: Same Reporter MOD21-024387:Crosslinked: Same Reporter MOD21-024396:Crosslinked: Same Reporter MOD21-024411:Crosslinked: Same Reporter",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/28/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Chills', 'Dizziness', 'Fall', 'Fatigue', 'Headache', 'Influenza like illness', 'Injection site pain', 'Malaise', 'Myalgia', 'Nausea', 'Pain in jaw', 'Pyrexia', 'Syncope']",2,MODERNA,OT 1053572,VT,90.0,F,"arrhythmias; rapid heartbeat; slight nausea; slight headache; light bothered vision for some days; mild chills; A spontaneous report was received from a retired nurse concerning herself who is 90 year old received Moderna COVID-19 vaccine and have experienced arrhythmias, rapid heartbeat, slight nausea, slight headache, some visual problems (light bothered her for some days) and mild chills. The patient has prior history of irregular heart beat . Her relevant concomitant medications were cholesterol medication, Crestor and medication for irregular heartbeat. No information on allergies. On 28-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of COVID-19 vaccine intramuscularly for the prophylaxis of COVID-19 infection. On 30-JAN-2021, 2 days after her vaccination, she developed arrhythmias, rapid heartbeat, slight nausea, slight headache, some visual problems (light bothered her for some days) and mild chills. After one week she felt like no more symptoms ongoing and felt good again. She visited her physician for arrhythmias, and he said, she should keep an eye on it, but no medication yet. She is concerned about her second shot. Action taken with 2nd dose of Moderna COVID-19 vaccine was not reported. The outcome of the events, arrhythmias, rapid heartbeat, slight nausea, slight headache, visual problems and chills were resolved at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. However, patient's advanced age and prior history of irregular heart beat are considered risk factors for arrhythmias.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/30/2021,2.0,UNK,CRESTOR,,Medical History/Concurrent Conditions: Heartbeats irregular,,,"['Arrhythmia', 'Chills', 'Headache', 'Heart rate increased', 'Nausea', 'Photophobia']",1,MODERNA,OT 1053573,,,U,"I have lost significant range of motion in my arm/shoulder; vaccine was given to high in my shoulder; Pain; A spontaneous report was received from a paramedic who was also a male patient of unknown age, who was administered Moderna's COVID-19 vaccine and experienced that the vaccine was given to high in shoulder (vaccine administered at inappropriate site), pain and lost significant range of motion in my arm/shoulder (injected limb mobility decreased). The patient's medical history was not reported. No relevant concomitant medications were reported. On 02 Feb 2021, the patient received the second dose of mRNA-1273 through an unknown route in an unknown arm for COVID-19 infection prophylaxis. On 02 Feb 2021, the patient reported that the vaccine was given to high in his shoulder and was injected into the bursa space and he had lost significant range of motion in his arm/shoulder and the pain was severe. The patient immediately obtained medical care within six hours of receiving the vaccine. The patient was admitted to an emergency room after the initial care in less than twenty-four hours and then eventually to the hospital floor. The patient's treatment included medical care. The action taken for Moderna COVID-19 vaccine was not applicable. The outcome of the events, lost significant range of motion in arm/shoulder and the pain were considered as unknown.The outcome of the event vaccine was given to high in shoulder was resolved.; Reporter's Comments: This case report concerns a male patient of unknown age who vaccine was given to high in shoulder (vaccine administered at inappropriate site) and experienced pain and lost significant range of motion in arm/shoulder for mRNA-1273, lot # unknown. The event of pain and lost significant range of motion in arm/shoulder are temporarily associated with the product use and a causal association cannot be excluded. The event of vaccine was given to high in shoulder is assessed as not applicable.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/02/2021,02/02/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Injected limb mobility decreased', 'Pain', 'Product administered at inappropriate site']",2,MODERNA,OT 1053574,OR,,F,"Vomiting and vomit had blood in it; Bloody nose; Vomiting; A spontaneous report was received from a consumer concerning a 61-year-old, female patient who received Moderna's COVID-19 vaccine and experienced bloody nose/epistaxis, vomiting and the vomit had blood in it/ hematemesis. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 10 FEB 2021, the patient received her second planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly in the left arm and administered by medical center for prophylaxis of COVID-19 infection. On 11 FEB 2021, in the morning the patient woke up with a bloody nose, vomiting and the vomit had blood in it. The treatment information for the events, were not provided. The patient had other medicine for her blood pressure and toe fungus. The action taken with the second dose of mRNA-1273 in response to the event was not applicable. The outcome of the events, bloody nose, vomiting and the vomit had blood in it were considered as unknown.; Reporter's Comments: This report concerns a 61-year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273, Lot number: 032L20A) and experienced bloody nose/epistaxis, vomiting and the vomit had blood in it/ hematemesis. Very limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,02/11/2021,31.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Epistaxis', 'Haematemesis', 'Vomiting']",1,MODERNA,OT 1053575,,,M,"Unresponsive/laying in bed still; Sleepy and stayed in bed after getting vaccine; pale; eyes half open and foam coming from mouth; A spontaneous report was received from Pfizer concerning a 66 year old male who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced being unresponsive/laying in bed, sleepy and stayed in bed after getting vaccine, pale, and eyes half open and foam coming from mouth. The patient's medical history was not provided. Concomitant medication use was not provided. On an unknown date, the patient received unknown dose number of two planned doses of mRNA-1273 ([LOT number, route and location unknown]) for prophylaxis of COVID-19 infection. On an unknown date, the patient, who resided in a senior home, stayed in bed the dat after getting the vaccine. Early the next morning, he was observed in bed lying still, pale, eyes half open and foam coming from the mouth. He was unresponsive. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events of unresponsive/laying in bed still, sleepy and stayed in bed after getting vaccine, pale, and eyes half open and foam coming from mouth/ was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (no medical history reported),,,"['Foaming at mouth', 'Pallor', 'Somnolence', 'Unresponsive to stimuli']",1,MODERNA,OT 1053576,AR,,F,"Lock down for dementia after first dose; A spontaneous report was received from a consumer concerning a female patient was participating in the mRNA-1273 Emergency Use Program and experienced lock down for dementia after first dose / dementia. The patient's medical history not provided. The patient's concomitant not provided. On 30th JAN 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On unknown date, the patient was in lock down for dementia. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, lock down for dementia after first dose, was not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Dementia'],1,MODERNA,OT 1053577,,,F,"hot flashes, below the arm right side of the body, hot sensation on and off comes frequently; right hip pain; This is a spontaneous report from a contactable pharmacist. This pharmacist (patient) reported that a 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Jan2021 (past Friday night) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 24Jan2021 (Sunday), patient experienced hot flashes, below the arm right side of the body, hot sensation on and off comes frequently. She also had right hip pain. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/24/2021,2.0,UNK,,,,,,"['Arthralgia', 'Hot flush']",UNK,PFIZER\BIONTECH, 1053578,TX,65.0,F,"The rash is up under arm, in armpit and is in the same arm of injection but there is no rash at the injection site.; because there was some itching under the arm. I went to see a dermatologist who says it has nothing to do with vaccine. I also had a slight headache; I also had a slight headache a day or two after the shot; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249, expiration date: unknown), via an unspecified route of administration on 14Jan2021 on left arm at a single dose for COVID-19 immunisation. Medical history included chronic kidney disease. The patient had chronic kidney disease and its real important for someone with her disease to get the vaccine, because if she got the actual virus it would hit the kidneys hard. The patient had no positive covid or antibody test prior to the vaccine. Concomitant medications were none. The patient stated that only thing she thinks would be related was that, she noticed this rather after using the hot tub, her husband just cleaned the hot tub and put chemicals in it, maybe she had a reaction to chemicals used to clean the hot tub. On 24Jan2021, the patient was reported after 10 days the patient had rash was up under the arm, near the arm pit, in the same arm of injection but there was no rash at the actual injection site, however her skin was beautiful, there was no spot except under the armpit. She got the injection a week ago Friday, she noticed the rash days later, on Sunday with itching under the arm. The Dermatologist says it has nothing to do with vaccine. The patient also had a slight headache a day or 2 (on 15Jan2021) after the shot, not a migraine, it was a slight dull headache, but went away. The patient went to the dermatologist yesterday, and he said it had nothing to do with the vaccine. She went to the dermatologist on 26Jan2021. Caller again stated that there was no rash at the injection site, but there was a rash underneath the arm in the arm pit. She still has it, she just started to use medicine last night. It's getting better. The Dermatologist prescribed a topical cream and its some kind of cortisone. The patient did not have any severe reaction like head swelling or swelling. The patient was scheduled for her second dose on 05Feb2021. The patient recovered from headache on 16Jan2021, recovering from rash, and for itching it was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/15/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Chronic kidney disease,,,"['Headache', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH, 1053579,,,F,"strong headaches; fever around 99.8 - 100 degree F; This is a spontaneous report from a non-contactable consumer. A female patient (reporter's wife) of an unspecified age receive BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 24Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that since Sunday morning, 24Jan2021, the patient has been suffering of strong headaches and fever. The patient experienced fever around 99.8 - 100 degree F and a very strong headache that cannot be controlled with medication. The outcome of the events was unknown. The events were reported as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/24/2021,01/24/2021,0.0,UNK,,,,,,"['Body temperature', 'Headache', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1053580,NJ,26.0,F,"Facial hives/hives on the face; might have caused a flare of my kidney disease; might have caused a flare of my kidney disease; This is a spontaneous report received from a contactable consumer (patient herself). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unspecified route of administration on 27Jan2021 09:45 on left arm at single dose for COVID-19 immunisation. Medical history included liver transplant and kidney disease. The patient previously took amoxicillin and had allergies. The patient did not receive other vaccine in four weeks prior to vaccination but received other medications (unspecified) in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 27Jan2021 12:00, the patient experienced facial hives/hives on the face and reported that it might have caused a flare of my kidney disease. The seriousness of the events was considered as non-serious by the reporter. Therapeutic measures were taken as a result of event facial hives/hives on the face included Benadryl. The outcome of the event hives was recovering, whereas unknown for other events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,PUB,,,Medical History/Concurrent Conditions: Liver transplant; Renal disease,,,"['Condition aggravated', 'Nephropathy', 'Urticaria']",1,PFIZER\BIONTECH, 1053581,WI,37.0,F,"Sever upper body itching; This is a spontaneous report from contactable nurse (patient). A 37-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date unknown) in the hospital via an unspecified route of administration on 13Jan2021 at 10:00 at a single dose on the right arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient previously took erythromycin and Polytrim and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe upper body itching on 13Jan2021. The itching started 7 hours after the vaccine. The patient received Benadryl, Zyrtec and Claritin as treatment. The patient recovered from the event. The event was reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,PVT,ZYRTEC [CETIRIZINE HYDROCHLORIDE],,,,,['Pruritus'],UNK,PFIZER\BIONTECH, 1053582,NM,24.0,M,"unable to bear weight on legs/could not walk or bear weight; shortness of breath; fever; nausea/nauseous; pain in left shoulder radiating to left chest 4/10; Chest pain at the side 5/10; tried to get up to walk but was very shaky and could not get up to walk/unable to walk/could not walk or bear weight; dizzy/light headed; almost instantly was sharp stinging in injection site; tried to get up to walk but was very shaky and could not get up to walk; WBC 14000, no unit of measurement, normal was 11000; This is a spontaneous report received from a contactable pharmacist and consumer (patient). A 24-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3302 and expiry date: May2021), via intramuscular route on deltoid left on 25Jan2021 15:57 at 0.3 ml single for COVID-19 immunization at hospital. Patient did not receive other vaccine in four weeks and in last two weeks. Patient's medical history, family medical history and concomitant medications were reported as none. Patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number; EL1284; expiry date: Apr2021) via intramuscular route on left deltoid on 04Jan2021 at 10:45 AM for COVID-19 immunization; Hep B Adult Energix-BPFS (HEPATITIS B VACCINE, lot number; 2793Z) on left deltoid on 12Jan2021. Patient received 3 previous doses of HEPATITIS B VACCINE. It was reported that, the patient complained of pain in left shoulder radiating to left chest 4/10 and nausea immediately following injection, Chest pain at the side 5/10 (on 25Jan2021 at 14;00, after second dose of COVID vaccine). Taken to the ED (emergency department) via wheelchair at 1700. No rash, no swelling of lips/tongue or throat. No treatment was given for the events nausea and pain in left shoulder. No COVID was presented prior vaccination and post vaccination. Patient stated almost instantly was sharp stinging in injection site, he felt nauseous, dizzy, light headed, and had chest pains, he tried to get up to walk but was very shaky and could not get up to walk on25Jan2021 at 14:00. Stated that he was wheeled to the emergency room, he was admitted to the emergency room for almost 8 hours. Clarified he was not admitted to the hospital that he did leave that night. He was able to stumble out of the emergency room to go home. Clarified he got the vaccine on 25Jan2021 (his second dose). Stated he woke up next morning on 26Jan2021, unable to bear weight on legs, chest pain, and shortness of breath, fever. HCP prescribed Arnuity for the chest pain. WBC 14000, no unit of measurement, normal was 11000. Patient was unable to walk, nausea, dizzy, lightheaded and having some chest pain and patient was not hospitalized, spent 8 hours in Emergency Room. Outcome of the event fever was recovered on 27Jan2021; nausea, dizziness, was recovered on 31Jan2021; Unable to walk, lower extremities weakness of, shortness of breath was recovering; the event chest pain was not recovered; and for remaining events it was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,PVT,,,,,,"['Arthralgia', 'Chest pain', 'Dizziness', 'Dyspnoea', 'Gait inability', 'Investigation', 'Muscular weakness', 'Nausea', 'Nervousness', 'Pyrexia', 'Vaccination site pain', 'White blood cell count', 'White blood cell count increased']",2,PFIZER\BIONTECH,OT 1053583,,,M,"redness at injection site of 3-4 inches; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced redness at injection site of 3-4 inches. The reporter wanted to know if there were any recommendations on how to treat this side effect. The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination site erythema'],UNK,PFIZER\BIONTECH, 1053584,CT,53.0,F,"slightly painful swollen lymph node on her left side near the clavicle and it was tender when touched; slightly painful swollen lymph node on her left side near the clavicle and it was tender when touched; This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration on the left arm, on 26Jan2021 13:00, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The vaccine was administered at the workplace clinic. The patient experienced having a slightly painful swollen lymph node on her left side near the clavicle and it was tender when touched on 27Jan2021 10:00. No treatment was received for the adverse events. The patient had not recovered from the adverse events at the time of the report. The patient has not been COVID tested post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,WRK,,,,,,"['Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH, 1053585,NJ,,F,"Tiredness; fever; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization. The first dose was received on an unspecified date. The patient's medical history and concomitant medications were not reported. The patient experienced tiredness and fever on 28Jan2021 which resulted in a clinic visit. Outcome of the event was unknown. The reporter considered the events non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/28/2021,0.0,PVT,,,,,,"['Fatigue', 'Pyrexia']",2,PFIZER\BIONTECH, 1053586,MI,,F,"Difficulty lifting arm; horrible night sweats; This is a spontaneous report from a contactable consumer. An elderly female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. Medical history included covid-19 prior to vaccination. The patient's concomitant medications were not reported. The patient experienced difficulty lifting arm and horrible night sweats the night of injection (27Jan2021) and difficulty lifting arm the following morning. The patient was not tested for covid post vaccination. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,,,Medical History/Concurrent Conditions: COVID-19 (If covid prior vaccination: Yes),,,"['Joint range of motion decreased', 'Night sweats']",UNK,PFIZER\BIONTECH, 1053587,CT,38.0,M,"Mild pain started about 8h after vaccination with the COVID-19 vaccine at the side of vaccination (left arm); This is a spontaneous report from a contactable consumer (patient himself). A 38-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3247, expiration date was unknown), via an unspecified route of administration in the left arm on 27Jan2021 at 13:00 at a single dose for COVID-19 immunization. The vaccine facility type was reported as the workplace clinic. The patient's medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination. The patient was not tested for COVID-19 post-vaccination. On 27Jan2021 at 21:00, the patient experienced mild pain started about 8 hours (8h) after vaccination with the COVID-19 vaccine at the side of vaccination (left arm). The patient did not receive any treatment for the adverse event (AE). The patient was recovering from the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,WRK,,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1053588,NY,,F,"palpitations; Fever of 101 (Degree)F; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of BNT162B2 (unknown lot number and expiration) for COVID-19 immunization on unspecified date. The patient called to report the side effects she experienced after administration of the second dose of the COVID-19 vaccine. She mentioned that 20 minutes after the administration of the second dose of the COVID-19 vaccine, she experienced palpitations and now she has a fever of 101 (Degree) F (unspecified dates). The patient was recommended by the nurse to manage fever with Tylenol. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Body temperature', 'Palpitations', 'Pyrexia']",2,PFIZER\BIONTECH, 1053589,GA,58.0,F,"Pain on left side especially in her neck swelling at her left clavicle painful to touch; Pain on left side especially in her neck swelling at her left clavicle painful to touch; Pain on left side especially in her neck swelling at her left clavicle painful to touch; Pain on left side especially in her neck swelling at her left clavicle painful to touch; This is a spontaneous report from a contactable nurse (patient herself). A 58-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3303, expiration date was unknown), intramuscularly in the left arm on 27Jan2021 at 12:30 at a single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142, expiration date was unknown) on 06Jan2021 at 12:45 AM, intramuscularly in the left arm for COVID-19 immunization. The patient had no medical history. The patient had no known drug allergies (NKDA). There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Jan2021 at 06:00 AM, the patient experienced pain on left side especially in her neck swelling at her left clavicle painful to touch, which was assessed as non-serious. The patient did not receive any treatment for the adverse event. The patient was not recovered from the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/28/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Bone pain', 'Bone swelling', 'Neck pain', 'Pain']",2,PFIZER\BIONTECH,OT 1053590,,,F,"high fever/ranging from 100.4F-104.4F; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. It was reported that the patient has had a high fever since the vaccine dose on 27Jan2021, ranging from 100.4F-104.4F. She stated she is taking Tylenol for it and wants to know what else to do. The outcome of the event was unknown. The event was reported as non-serious. Information on the lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,,,,,,"['Body temperature', 'Pyrexia']",2,PFIZER\BIONTECH, 1053591,MO,57.0,F,"Severe leg and hip pain; Severe leg and hip pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 22Jan2021 09:00 (at the age of 57years) at single dose for Covid-19 immunization. Medical history included migraine. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included ibuprofen (ADVIL), levothyroxine sodium (SYNTHROID), amitriptyline, rizatriptan benzoate (MAXALT), and butalbital, caffeine, paracetamol (FIORICET); all taken from an unspecified date for an unspecified indication. The patient previously took compazine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 06:00, the patient experienced severe leg and hip pain. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. This case is non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/26/2021,4.0,PVT,ADVIL; SYNTHROID; AMITRIPTYLINE; MAXALT; FIORICET,,Medical History/Concurrent Conditions: Migraine,,,"['Arthralgia', 'Pain in extremity']",1,PFIZER\BIONTECH, 1053592,NY,34.0,F,"Fever; headache; body aches; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL8983) intramuscular on the left arm on 27Jan2021 08:30 at a single dose for Covid-19 immunization. Medical history included allergies, sinus (disorder), hearing loss and allergies: shellfish and sulfa. The patient previously received first dose of BNT162B2 on 04Jan2021 for COVID-19 immunization (first dose, 04:00 PM Intramuscular on the left arm lot number: EL 0142). Concomitant medication included nigella sativa (black seed oil), turmeric [curcuma longa rhizome] and multivitamins. On 28Jan2021 05:00 AM, the patient experienced fever, headache and body aches. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Patient was not pregnant. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/28/2021,1.0,PVT,NIGELLA SATIVA; TURMERIC [CURCUMA LONGA RHIZOME],,Medical History/Concurrent Conditions: Allergy; Hearing loss; Shellfish allergy; Sinus disorder; Sulfonamide allergy,,,"['Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,OT 1053593,,48.0,F,"Headache; Fever; Body aches; Fatigue; stiffness in neck; This is a spontaneous report from a contactable nurse (patient). A 48-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine 2 dose 2 days ago on Tuesday and from Tuesday night, she had pretty significant headache, fever, body aches, fatigue, and stiffness in neck. The patient wanted to know if that is normal and how long they last. The outcome of the events was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/26/2021,0.0,UNK,,,,,,"['Fatigue', 'Headache', 'Musculoskeletal stiffness', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1053594,MN,65.0,F,"Hot red face and neck; Hot red face and neck; possible slight swelling of face and eyes (minor); possible slight swelling of face and eyes (minor); chills; headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264 and expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 15:15 at a single dose for COVID-19 immunization. Medical history included hypertension and kidney disease, and was allergic to bee stings, penicillin, aluminum chloride. Patient was not pregnant at the of vaccination. There were unspecified medications received within 2 weeks of vaccination, and no other vaccine in 4 weeks prior to. The patient experienced hot red face and neck, possible slight swelling of face and eyes (minor), chills and headache on 29Jan2021 15:30. Outcome of the events was recovered. No treatment was received for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PUB,,,Medical History/Concurrent Conditions: Allergy to aluminum; Bee sting hypersensitivity; Hypertension; Penicillin allergy; Renal disease,,,"['Chills', 'Erythema', 'Eye swelling', 'Feeling hot', 'Headache', 'Swelling face']",UNK,PFIZER\BIONTECH, 1053595,NC,59.0,F,"Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen lymph glands right armpit; sore injection site; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 12:30, at single dose, for COVID-19 immunization, at the workplace clinic. Medical history included penicillin allergy, hypertension (HTN), obesity, hypothyroidism, iron deficiency anemia, s/p gastric bypass in 2010 (11 years), and GERD. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. Concomitant medications (other medications in two weeks) included amlodipine benazapril, levothyroxine and pantoprazole. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0140, expiry date: unknown) received at 59 years of age, via an unspecified route of administration on the left arm, on 04Jan2021 12:30, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 26Jan2021 at 01:00, the patient experienced fever 100-103, severe chills, body and joint aches, weakness, fatigue, swollen lymph glands right armpit and sore injection site. The patient was not tested for COVID-19 post vaccination. No treatment was given for the events. The patient was recovering from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,WRK,AMLODIPINE BENAZEPRIL; LEVOTHYROXINE; PANTOPRAZOLE,,Medical History/Concurrent Conditions: Gastric bypass; GERD; Hypertension; Hypothyroidism; Iron deficiency anemia; Obesity; Penicillin allergy,,,"['Arthralgia', 'Asthenia', 'Body temperature', 'Chills', 'Fatigue', 'Lymphadenopathy', 'Pain', 'Pyrexia', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1053596,AL,,F,"Experienced a low grade fever; body aches; This is a spontaneous report from a non-contactable consumer. A 34-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 24Jan2021 at 10:30 at a single dose on the right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Last Monday (25Jan2021), the patient experienced a low grade fever and body aches. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 26Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/24/2021,01/25/2021,1.0,SCH,,,,,,"['Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1053597,AL,52.0,F,"Eyes have gotten worse; red streaks going up arms and splotches/ splotchy red whelps and streaks up her arm; real red spot on wrist; her arms started stinging and itching; Hand and feet were itching off; burning; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1283) intramuscular on the left arm on 13Jan2021 13:15 at a single dose for COVID-19 immunization. Medical history included acid reflux, antidepressant, normally wears contacts and puts reading glasses on over it. Family medical history of cancer. Concomitant medication included omeprazole (PROTONIX [OMEPRAZOLE]) for acid reflux and bupropion hydrochloride (WELLBUTRIN) as antidepressant. The patient went and got her first shot 2 weeks ago. She is a dental assistant. She woke up between 2am-3am on 13Jan2021 and her hands and feet were itching off. They were burning and itching and she did not have any rash. So Thursday, she had to work until 1. Her hands itched and she went home, took Benadryl and put Cortisone cream on hands and feet. She does not have a dose, lot or expiration for either. It would take 2 doses of Benadryl. They just continued to itch until Saturday and she went to a doc in the box and the doctor felt it was a reaction from the vaccine. You could not see anything except red where she scratched it. She gave her some medicine and she just went to pharmacy and the pharmacist said that is just like Benadryl. She started taking it and it immediately helped, but she only gave it to her for 5 days and when she finished, the itching started again. On 27Jan2021, her hands were itching off and she has red streaks going up arms and splotches. She does not have the name. It was like hydro something. She threw bottle away. She does not have a dose, lot or expiration. It improved and stopped when she was taking the medicine and on 26Jan2021, she had a real red spot on wrist, her hands have itched and itched. When her arms started stinging and itching, she pulled her sleeve up and it looks like streaks on her arms and elbows. She has these splotchy red whelps and streaks up her arm. She also noticed she had itching on her torso the day before. She needed to get glasses to see vaccine card. This was required before she took the vaccine, but she did feel like her eyes are worse all of a sudden. She normally wears contacts and puts reading glasses on over it. It has only been in the last few weeks that she has noticed this. Now, her arms were starting to itch again after a dose of Benadryl. She was worried about 2nd shot. She does not want it to get worse and continue. She would like to speak with someone to find out if it would be recommended for her to get second dose or not. No ER or physician's office required: Doctor visit on 16Jan2021 and they prescribed a medication to help with itching and burning for 5 days and it worked and when she stopped taking it, it started back. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the vaccine was administered was at a Clinic for the hospital. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. Outcome of the events itching and eyes have gotten worse was not recovered, events burning and pain in arm was unknown and recovering for the other events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/13/2021,0.0,PVT,PROTONIX [OMEPRAZOLE]; WELLBUTRIN,,Medical History/Concurrent Conditions: Acid reflux (esophageal); Antidepressant therapy; Cancer; Eyeglasses wearer,,,"['Burning sensation', 'Erythema', 'Pain in extremity', 'Pruritus', 'Vaccination site erythema', 'Visual impairment']",1,PFIZER\BIONTECH,OT 1053598,WI,91.0,F,"hands are really itching, palm of hands itching, knee might itch a bit; This is a spontaneous report from a contactable consumer reporting for herself. A 91-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration (injection given in left arm) on 27Jan2021 11:00 at SINGLE DOSE for COVID-19 immunization. The patient has no medical history. The patient was taking unspecified concomitant medications (takes a lot of mediations but they are the same thing she has taken for a long time. Nothing was new). The patient experienced palm of hands itching, knee might itch a bit on 27Jan2021. Patient reported she walked outside for about a half an hour; she didn't have anything on her hands. However, when she came back inside, her hands were really itching, specifically the palm of her hands. She has never had this happen before. She came back inside and took her mask and coat off and when she started to get warm, her hands started itching. She stated it's like the cold caused the itching or something. The itching has stayed the same. It was just itchy. She stated her knee might itch a bit, but her hands are really itching. She was not given her vaccine record card. Her facility is saving it and will give it to her after her second vaccine. No investigation assessment reported. Event outcome was not recovered. Information on Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No",,,['Pruritus'],1,PFIZER\BIONTECH, 1053599,,,U,"flushing on the face; burning on the face and on the both arms; skin is burning; Nauseous; Appetite vacillates; Chills; Sore throat; Body ache; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was stated, ""I can tell you side effect I am getting now, so you can't tell me if you ever heard the side effects or not, I am getting flushing on the face and I am getting burning on both arms, I am getting burning on the face and on the both arms, the other one would be normal one's except the extremely nauseous, my appetite vacillates, extremely nauseous this the 3rd day now after the shot and burning on both arms, of course chills you probably heard of chills, I also was getting sore throat and either the body ache you heard of but I think to press option 3 and call but I wanted to you know the burning in the arm and in the face, like skin is burning."" The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Appetite disorder', 'Burning sensation', 'Chills', 'Flushing', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Skin burning sensation']",1,PFIZER\BIONTECH, 1053600,,35.0,F,"Chills; Arm Soreness; Malaise; sore throat; warm body feeling; This is a spontaneous report from a non-contactable consumer. A 35-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) on her right arm, via an unspecified route of administration on 04Feb2021 13:30 at a single dose for covid-19 immunization. Medical history included thyroid condition and environmental allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC) and levothyroxine. The patient experienced Chills, Arm Soreness, Malaise, slight sore throat, warm body feeling; all for 05Feb2021 10:00AM. No treatment was received for the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,WRK,ZYRTEC; LEVOTHYROXINE,,Medical History/Concurrent Conditions: Environmental allergy; Thyroid disorder,,,"['Chills', 'Feeling hot', 'Malaise', 'Oropharyngeal pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 1053601,NJ,31.0,M,"Slept longer than usual; Triceps pain; This is a spontaneous report from a contactable healthcare professional (patient himself, physical therapist) via Pfizer colleague. A 31-year-old male patient received first dose of bnt162b2 (PFIZERBIONTECH COVID-19 VACCINE, lot number: EL9264 and expiry date: 31May2021), intramuscular on 04Feb2021 at single dose for COVID-19 immunization. The patient was vaccinated at a hospital. Medical history and concomitant medications were not reported. The patient previously received hepatitis B vaccine last 12Jan2021. On 04Feb2021, the patient reported that after the vaccination, he slept longer than usual during the night. The patient also reported that he experienced triceps pain (not at the injection site area). Clinical outcome of the event slept longer than usual was unknown, while for triceps pain was not recovered as of time of report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,PVT,,,,,,"['Hypersomnia', 'Myalgia']",1,PFIZER\BIONTECH,OT 1053602,WI,40.0,F,"light headed; woke up with hives on my neck; This is a spontaneous report from a contactable Other Health Professional (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number PAA15 6651), via an unspecified route of administration in left arm on 03Feb2021 09:00 at single dose for Covid-19 immunization. Medical history included allergies to medications, food, or other products: Penicillin. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Prior to vaccination, was the patient diagnosed with COVID-19: No. There were no concomitant medications. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: None. The patient previously took erythromycin and experienced Allergies: erythromycin. The patient experienced light headed and woke up with hives on her neck on 04Feb2021 06:00 with outcome of recovered in Feb2021. Since the vaccination, has the patient been tested for COVID-19: Yes. The patient underwent lab tests and procedures which included BinaxNOW Covid-19 Ag Nasal Swab: negative on 05Feb2021 and negative on 08Feb2021. No treatment received for the adverse event. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/04/2021,1.0,WRK,,,"Medical History/Concurrent Conditions: Penicillin allergy (Allergies to medications, food, or other products: Penicillin and erythromycin)",,,"['Dizziness', 'SARS-CoV-2 test', 'Urticaria']",1,PFIZER\BIONTECH, 1053603,AZ,,F,"fatigued; anxiety; WBC was a little low; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. A 77-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on unspecified date, at single dose, for COVID-19 immunisation and palbociclib (IBRANCE), via an unspecified route of administration, from 06Jan2021 to an unspecified date, at 125 mg cyclic, for an unspecified indication (patient was on her 7 day break from 1st cycle). The patient's medical history and concomitant medications were not reported. The patient experienced fatigued on an unspecified date with outcome of unknown, anxiety on an unspecified date with outcome of unknown, white blood cell (WBC) was a little low in Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included white blood cell count: low in Jan2021. The action taken in response to the events for palbociclib was unknown. She stated that fatigue could maybe be a result of her poor sleep due to anxiety. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/01/2021,,UNK,Ibrance,,,,,"['Anxiety', 'Fatigue', 'White blood cell count', 'White blood cell count decreased']",1,PFIZER\BIONTECH, 1053604,MN,70.0,F,"severe back pain; unable to urinate; may have passed a kidney stone; Bladder infection; This is a spontaneous report from a contactable consumer who reported for herself. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EL3247; expiry date: May2021), via an unspecified route of administration on 26Jan2021 at 12:00 (at the age of 70-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were both reported as none. The patient did not receive any other vaccines on the same date as the COVID-19 vaccination or within four weeks prior to the vaccination. On 08Feb2021 the patient experienced bladder infection and may have passed a kidney stone; on unspecified dates the patient experienced severe back pain and unable to urinate. The clinical course was reported as follows: ""The patient received the first dose of the COVID-19 vaccine two weeks ago. She reported no side effects from the first dose of the vaccine; however, she was currently on an antibiotic for a bladder infection. She was scheduled to get the second dose on 16Feb2021; however, this weekend she developed a bladder infection and was on an antibiotic. She had symptoms on Sunday, and she saw her doctor on Monday. She also may have passed a kidney stone, but she was not certain. She had severe back pain and was unable to urinate."" The patient read to not take any shots while taking the antibiotic. She would be off of the shot (as reported) for four days when she would get the next dose of the vaccine. The patient wanted to know ""how many days would she need to be off of the antibiotic before she could get the next dose?"" She stated that she would stop taking the antibiotic if she had to. She took one dose of the antibiotic on Monday and two doses today. The patient also inquired whether the side effects were different after the 2nd dose of the vaccine and how long she had to be off her antibiotics before getting her second dose of the COVID vaccine. The patient was taking sulfamethazole-TMP DS as treatment for the bladder infection since 08Feb2021. The patient sought care at the physician's office for the event bladder infection. Relevant tests were reported as none. The clinical outcome of the event bladder infection was recovering/resolving; the clinical outcomes of the events may have passed a kidney stone, severe back pain and unable to urinate were all unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,02/08/2021,13.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Back pain', 'Cystitis', 'Nephrolithiasis', 'Urinary retention']",1,PFIZER\BIONTECH, 1053605,VA,27.0,F,"I have an itchy rash all over my body; little white bumps; This is a spontaneous report received from a contactable consumer (patient herself). A 27-year-old female patient (not pregnant at the time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number; E19269) via an unspecified route of administration on right arm on 03Feb2021 18:30, at single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs. Concomitant medications included unspecified birth control within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated that she had an itchy rash all over her body, they were little white bumps on 04Feb2021. The patient was not received any treatment for the events. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. Seriousness of the events was assessed as non-serious by the reporter. The outcome of the events was reported as not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,"['Rash pruritic', 'Skin lesion']",1,PFIZER\BIONTECH, 1053606,MI,53.0,M,"Within a week after receiving the first round of vaccine I have developed two blood clots in my left leg.; This is a spontaneous report from a contactable consumer (patient) A 53-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) on 21Jan2021 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. The patient didn't have medical history or concomitant medications. On an unspecified date in Jan2021 within a week after receiving vaccine patient developed two blood clots in his left leg. As treatment patient was currently on blood thinners. At the time of the reporting event outcome was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/01/2021,,WRK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Other medical History: None",,,['Thrombosis'],1,PFIZER\BIONTECH, 1053607,CA,46.0,F,"After 15 months of amenorrhea I have spotting/ bleeding and cramps the day following my first COVID-19 vaccine; After 15 months of amenorrhea I have spotting/ bleeding and cramps the day following my first COVID-19 vaccine; After 15 months of amenorrhea I have spotting/ bleeding and cramps the day following my first COVID-19 vaccine; This is a spontaneous report from a contactable other healthcare professional (patient). A 46-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number: EN6201; expiry date: unknown) via an unspecified route of administration in the left arm, on 09Feb2021 at 16:15, at a single dose, for COVID-19 immunization. Medical history included asthma and amenorrhea. The patient had no known allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Facility where vaccine was administered was reported as other. Concomitant medication included ibuprofen (Advil PM). After 15 months of amenorrhea, the patient had spotting/ bleeding and cramps the day following her first COVID-19 vaccine. The events occurred on 10Feb2021, at 8:00 A.M. The patient did not receive therapy for the events. Outcome of the events was unknown. The patient has not been tested for COVID-19 since vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,02/10/2021,1.0,UNK,ADVIL PM [DIPHENHYDRAMINE CITRATE;IBUPROFEN],,Medical History/Concurrent Conditions: Amenorrhea; Asthma,,,"['Dysmenorrhoea', 'Menorrhagia', 'Metrorrhagia']",1,PFIZER\BIONTECH, 1053608,,,F,"Swollen and painful supra clavicular lymph node left side.; Swollen and painful supra clavicular lymph node left side.; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 04Feb2021 at a single dose for COVID-19 immunization. Medical history included lupus and allergies to latex. Patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced Swollen and painful supra clavicular lymph node left side on 10Feb2021. The patient underwent lab tests and procedures which included nasal swab: negative on 04Nov2020. Outcome of the event was not recovered. Patient was not diagnosed with COVID-19 prior to vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/10/2021,6.0,UNK,,,Medical History/Concurrent Conditions: Latex allergy; Lupus syndrome,,,"['Lymph node pain', 'Lymphadenopathy', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1053609,CA,42.0,F,"tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes; tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes; Brief period of pain in my right bicep; Headaches off and on; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN0201, expiry date: unknown), via an unspecified route of administration on the left arm, on 10Feb2021 09:30, at single dose, for covid-19 immunisation, at the hospital. Medical history included anxiety and bipolar II disorder (reported as bipolar2). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Concomitant medications included fluoxetine hydrochloride (PROZAC), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), quetiapine fumarate (SEROQUEL) and ""OTC vit"" (as reported). The patient previously took lamotrigine and experienced allergies (known allergies: Lamotrigine). The patient did not receive any other vaccines prior to the COVID vaccine. On 10Feb2021 at 20:00, the patient experienced ""brief period of pain in my right bicep, headaches off and on, tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes"". Treatment for the event ""headache off and on"" included 2 doses of 2 pills of acetaminophen. No treatment was given for the events ""brief period of pain in my right bicep"" and ""tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes"". The patient recovered from the events on an unspecified date. The events were assessed as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,PVT,PROZAC; ALLEGRA; FLONASE; SEROQUEL,,Medical History/Concurrent Conditions: Anxiety; Bipolar II disorder (bipolar2),,,"['Headache', 'Hypoaesthesia', 'Myalgia', 'Paraesthesia']",1,PFIZER\BIONTECH, 1053610,TX,66.0,F,"mouth sores; Numbness of left arm, shoulder and left side of face; some tongue swelling.; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration at the age of 66 years, on 10Feb2021 09:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing, drug hypersensitivity (sulfa drugs) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took tetracyclines and experienced drug hypersensitivity, pneumovax vaccin and experienced drug hypersensitivity. On 10Feb2021, the patient experienced numbness of left arm, shoulder and left side of face and some tongue swelling. The patient applied ice for several hours. After 5 hours or so, the face and tongue were back to normal. The following day (11Feb2021), they noticed mouth sores. The patient used salt water rinse to help. The patient asked if she should be avoiding the 2nd dose scheduled in 18 days as a result of this reaction. Therapeutic measures were taken as a result of numbness of left arm, shoulder and left side of face (hypoaesthesia), some tongue swelling. (swollen tongue), mouth sores (stomatitis). The outcome of the events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/10/2021,0.0,UNK,SYNTHROID,,Medical History/Concurrent Conditions: Hypothyroidism (Hypothyroid); Sulfonamide allergy (known_allergies: sulfa drugs),,,"['Hypoaesthesia', 'Stomatitis', 'Swollen tongue']",1,PFIZER\BIONTECH, 1053611,FL,42.0,F,"Tingling to hands and feet X 3 weeks; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 19Jan2021 13:00 at a single dose for covid-19 immunization. Medical history included palpitations. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 (first dose). The patient experienced tingling to hands and feet x 3 on 21Jan2021 14:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Feb2021. No treatment has been received for the events. The outcome of the event was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/21/2021,2.0,SEN,,,Medical History/Concurrent Conditions: Palpitations,,,"['Paraesthesia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1053612,CT,55.0,F,"Headache; body aches; neck and shoulder pain; neck and shoulder pain; This is a spontaneous report from a non-contactable consumer or other non hcp. A 55-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9264), via an unspecified route of administration left arm single dose on 10Feb2021 15:00 for covid-19 immunisation. The patient received the first dose on 20Jan2021 lot#lEL9263. The patient medical history was not reported. No other vaccine was received in four weeks. The patient's concomitant medications were not reported. The patient experienced headache on 11Feb2021 12:00, body aches on 11Feb2021 12:00, neck and shoulder pain on 11Feb2021 12:00. No treatment received. The events recovered in Feb2021 No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/11/2021,1.0,PUB,,,,,,"['Arthralgia', 'Headache', 'Neck pain', 'Pain']",2,PFIZER\BIONTECH, 1053613,MA,28.0,M,"Soreness at the injection site/tenderness of arm; Soreness at the injection site/tenderness of arm; This is a spontaneous report from a contactable consumer (patient). This 28 -year-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration, on 11Feb2021 (at 15:45) at a single dose on right arm for COVID-19 immunisation, administered at Workplace clinic. No relevant medical history and concomitant medications were provided. No known allergies.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 before vaccine. On 11Feb2021 (at 22:00), the patient had soreness at the injection site/tenderness of arm. The events were reported as non-serious. Post vaccination COVID test was not performed. The patient was not treated for the events. The patient was recovering from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,WRK,,,,,,"['Pain in extremity', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1053614,OH,62.0,F,"persistant nausea/nausea become much worse on day 4; fatigue; slight appetite loss; unable to eat normally; lost much weight; This is a spontaneous report from a contactable consumer reported for herself. A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EM980) , on 04Feb2021 at 16:00 (at 62 years) at single dose in left arm for covid-19 immunisation . Medical history included glucose intolerance. Patient was not pregnant.Concomitant medication included atenolol and calcium/ergocalciferol (CALCIUM/VITAMIN D). The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) and experienced allergy. On 08Feb2021 at 08:00 (as reported) the patient experienced persistent nausea, fatigue, slight appetite loss, unable to eat normally and lost much weight, all non serious. Events were described as follows: patient had persistent nausea. The first few days she had the expected side effects of fatigue and slight appetite loss. The fatigue resolved on the second day, but the nausea become much worse on day 4. She had been unable to eat normally since then and had lost much weight that she cannot afford to lose. She kept hoping that it will go away, but it was 8 days after her shot and she still had nausea (as reported). Anti nausea medicine was administered, no treatment given for the other events. Patient recovered from fatigue in Feb2021; outcome of the other events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/08/2021,4.0,SCH,ATENOLOL; CALCIUM/VITAMIN D,,Medical History/Concurrent Conditions: Glucose intolerance,,,"['Decreased appetite', 'Eating disorder', 'Fatigue', 'Nausea', 'Weight decreased']",1,PFIZER\BIONTECH, 1053615,AL,59.0,F,"Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; elevated heart rate; rash on face, neck and chest; Enlarged lymph nodes; dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on right arm on 09Feb2021 at 15:45 at a single dose for COVID-19 immunisation in the hospital. Medical history was none. The patient had no allergies to medications, food, or other products. Concomitant medications included furosemide (LASIX) and other blood pressure meds (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 09Feb2021, at 16:45 the patient had difficulty breathing, swelling in face, neck, throat and tongue, elevated heart rate, rash on face, neck and chest, enlarged lymph nodes and dizziness. The patient assessed the events as non-serious. Steroids, Benadryl, Pepcid, antibiotics were given as treatment in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/09/2021,0.0,PVT,LASIX,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dizziness', 'Dyspnoea', 'Heart rate', 'Heart rate increased', 'Lymphadenopathy', 'Pharyngeal swelling', 'Rash', 'Swelling', 'Swelling face', 'Swollen tongue']",1,PFIZER\BIONTECH, 1053617,MS,67.0,F,"running fever; This is a spontaneous report from a contactable consumer reporting for herself. A 67-years-old female patient received bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration in the right arm on 06Feb2021 15:30 at single dose for covid-19 immunisation . Medical history included blood pressure abnormal and blood cholesterol increased. The patient experienced running fever on 08Feb2021 20:00 with outcome of not recovered. The patient was hospitalized on an unknown date for running fever . The patient underwent lab tests and procedures which included body temperature: still running temp on Feb2021, Sars-cov-2 test: negative on 12Feb2021. The patient has received antibiotics as a treatment for pyrexia. At the time of the vaccination the patient was not pregnant and after being vaccinated she was tested negative to Sars-Cov-2 Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/06/2021,02/08/2021,2.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure abnormal (Blood pressure); High cholesterol,,,"['Body temperature', 'Pyrexia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1053618,NY,56.0,F,"Itchy; Runny nose; swelling on site; Very little redness when I got the vaccine/ very red; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), via an unspecified route of administration on the left arm on 05Feb2021 at 09:30 at a single dose for COVID-19 immunization. Medical history included palpitations controlled by medicine. The patient has no allergies to medications, food, or other products. Concomitant medication included metoprolol (METOPROLOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had a little swelling on the site and very little redness when she got the vaccine. However, on the 8th day it was a bigger area, itchy and very red. No pain or other symptoms. The patient did start with a runny nose the day after the vaccine and still have, but not sure it's related. No treatment administered for the events. The events had not resolved. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,UNK,METOPROLOL,,Medical History/Concurrent Conditions: Palpitations (controlled by medicine),,,"['Rhinorrhoea', 'Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 1053619,MA,,F,"patient had her test done on 29Jan2021 and it came back positive for COVID; patient had her test done on 29Jan2021 and it came back positive for COVID; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 12Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history included the patient had a handicap. Concomitant medications were not reported. The patient who lived in a group home had her first dose of the Pfizer COVID-19 Vaccine on 12Jan2021. She was then exposed to someone who was positive for COVID within the group home. The patient went to live with her mother (reporter). The patient had her test done on 29Jan2021 and it came back positive for COVID (also reported that the patient tested positive last 31Jan2021). Therefore, she could not go and get her second scheduled Pfizer COVID vaccine. The nurse who oversaw the group home house scheduled the second dose for 23Feb2021 which was six weeks since the first dose. The reporter was inquiring to find out if that was okay and if it would still work. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 29Jan2021. Outcome of the events was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/29/2021,17.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1053620,TX,,M,"Patient was positive of COVID 19 in between doses; Patient was positive of COVID 19 in between doses; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (parent). A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history included T-cell lymphoblastic leukemia acute (in remission). Concomitant medications were unknown. On an unspecified date, after the first dose, the patient was tested positive for COVID 19. It was confirmed that patient was positive of COVID 19 in between doses. Clinical outcome was unknown at time of this report. The information on the lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: T-cell lymphoblastic leukemia acute (T-cell lymphoblastic leukemia acute (in remission)),,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1053621,IL,40.0,F,"Irregular menstrual cycles (3 periods in 6 weeks); Irregular menstrual cycles (3 periods in 6 weeks) and extremely heavy bleeding; This is a spontaneous report from a contactable nurse reported for herself. A 40 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) via an unspecified route of administration on 21Dec2020 02:45 PM at age of 40 years old in left arm at single dose for covid-19 immunisation. Medical history included there was no known allergies. No covid prior vaccination. And no other medical history. Patient was not pregnant. Concomitant medications were none. Previously there was no other vaccine in four weeks. No other medications in two weeks. Patient experienced irregular menstrual cycles (3 periods in 6 weeks) and extremely heavy bleeding with several clots starting one week after first vaccine. The adverse events started date was on 31Dec2020. Patient had the doctor or other healthcare professional office/clinic visit. There was no treatment. No covid tested post vaccination. Outcome of events were unknown. Patient received the second dose of BNT162B2 (lot number= EL1283) on 11Jan2021 09:15 AM in left arm for covid-19 immunisation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,12/31/2020,10.0,PVT,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: other medical history: None",,,"['Menorrhagia', 'Menstruation irregular']",1,PFIZER\BIONTECH, 1053661,KS,,M,"Received his first dose of the vaccine and later developed pneumonia.; A spontaneous report was received from a health care professional concerning a male who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced received his first dose of the vaccine and later developed pneumonia The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient developed pneumonia after receiving his first dose. No treatment was reported. Action taken with mRNA-1273 in response to the event was not provided. The outcome for the event, received his first dose of the vaccine and later developed pneumonia was unknown.; Reporter's Comments: The event of pneumonia was more consistent with infectious process in pandemic set up.Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported patient history.),,,['Pneumonia'],1,MODERNA,OT 1053662,TX,74.0,F,"Passed out because her sugar went down 1.30 and blood pressure went down; Shaking; Started having twinkle tongue, tongue started getting heavy; A spontaneous report was received from a consumer, a 74-year-old female patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced started having twinkle tongue, tongue started getting heavy/ paresthesia oral, passed out because her sugar went down 1.30 and blood pressure went down/ loss of consciousness and shaking/tremor. The patient's medical history included was asthma from an unknown date. Products known to have been used by the patient, within two weeks prior to the event, included ""advitrol inhaler"" as an indication for asthma from an unknown date, levocetirizine dihydrochloride, ""blood pressure pills"" and ""asthma medication"" from an unknown date. On 18 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) and expiration date 03 Jul 2021 intramuscularly in her left arm for prophylaxis of COVID-19 infection. On 18 Jan 2021, approximately fifteen minutes after the vaccine, the patient started having twinkle tongue, tongue started getting heavy when she was on her way home. The patient had asthma so she took her medication and was okay. One week later on an unknown date, the patient passed out because her sugar went down 1.30 and blood pressure went down and was shaking which lasted for ten seconds. The patient mentioned something like that never happened before. The patient also mentioned she was having asthma issues so was waiting to see her allergies Doctor and was tested for covid-19 on an unknown date but had no result yet. Treatment information was not provided. The Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, started having twinkle tongue, tongue started getting heavy was considered as recovered on 18 Jan 2021. The outcome of events, passed out because her sugar went down 1.30 and blood pressure went down and shaking were unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. The patient reports that she passed out because her sugar went down and blood pressure went down. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/18/2021,0.0,UNK,XYZAL,,Medical History/Concurrent Conditions: Asthma,,,"['Blood glucose', 'Blood pressure measurement', 'Loss of consciousness', 'Paraesthesia oral', 'Tremor']",1,MODERNA,OT 1053663,NC,54.0,F,"Bell's Palsy; A spontaneous report was received from a physician concerning a 54 year old female patient. The patient's medical history was not provided. No relevant concomitant medication was reported. On 03Feb2021, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection. On 04Feb2021, the patient experienced waking with Bell's Palsy. No treatment was reported. Action taken with the mRNA-1273 in response tot he event was not reported. The outcome of the event, facial paralysis, was unknown.; Reporter's Comments: This report concerns a 54-year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273). (Lot # not reported) and experienced Bell's palsy. Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/04/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Facial paralysis'],1,MODERNA,OT 1053664,TX,73.0,M,"Occlusion on right eye; Can't see out of his right eye; hemorrhage in right eye; Case reference number MOD-2021-012734 is a spontaneous case report sent by a Non-Healthcare Professional on 09-FEB-2021, which refers to a male patient who received the first dose of Moderna's COVID-19 Vaccine (mRNA-1273) and experienced occlusion of the right eye and blindness in the right eye which required hospitalization and the event of hemorrhage in the right eye. The patient's medical history included a shunt installation for hydrocephalus. The patient's medication history included amoxicillin, omeprazole, potassium citrate, sertraline hydrochloride, tamsulosin, amoxicillin trihydrate, benzydamine hydrochloride, bromhexine hydrochloride, trospium and unspecified sinus medications. On 15JAN2021, the patient received the first dose of Moderna COVID-19 (mRNA-1273) Vaccine (Lot: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 17JAN2021, the patient's wife reported that the patient couldn't see out of his right eye. He went to the emergency room and his ophthalmologist reported that the patient had an occlusion on the right eye which was not a result of the vaccine. On 19JAN2021, the patient left the hospital. Later that same week, the patient visited another ophthalmologist that observed a hemorrhage on his right eye with an unknown etiology. On 04FEB2021, the patient went to the dentist where multiple infections and molars were identified. Treatment included amoxicillin 875mg for 10 days. Action taken for the events of occlusion of the right eye, blindness in the right eye and hemorrhage in the right eye associated with mRNA-1273 was not reported. The outcome of the events was unknown.; Reporter's Comments: This case concerns a 73-year-old male patient, who experienced a serious unexpected events of vascular occlusion, blindness, and eye hemorrhage, after receiving first dose of mRNA-1273 (lot # 041L20A). Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/15/2021,01/17/2021,2.0,UNK,AMOXICILLIN; OMEPRAZOLE; POTASSIUM CITRATE; SERTRALINE HCL; TAMSULOSIN; SINUS [AMOXICILLIN TRIHYDRATE;BENZYDAMINE HYDROCHLORIDE;BROMHEXINE HYDROCHLORIDE]; TROSPIUM,"Anxiety; Gastroesophageal reflux; Hydrocephalus (Six months prior to vaccination, patient had a shunt inserted for hydrocephalus.); Kidney stones",Medical History/Concurrent Conditions: Tooth infection,,,"['Blindness', 'Eye haemorrhage', 'Vascular occlusion']",1,MODERNA,OT 1053665,NJ,28.0,F,"Several drops of vaccine squirted out of the arm; Several drops of vaccine squirted out of the arm; A spontaneous report was received from a consumer concerning a 28-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and when given the vaccine, several drops of the vaccine squirted out of the arm. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their second of two planned doses of mRNA-1273 (Batch number: 030L20A) on 10-FEB-2021. On 10-FEB-2021, the patient received the second dose of Moderna vaccine. Consumer reported that when given the vaccine, several drops of vaccine squirted out of the arm. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The event outcome was considered resolved on 10-FEB-2021.; Reporter's Comments: This report refers to a case of Vaccine Underdose and exposure via skin contact for mRNA-1273, lot #030L20A with no associated Adverse event.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Exposure via skin contact', 'Underdose']",2,MODERNA,OT 1053666,TN,49.0,F,"and the nurse ended up sticking herself; Hives; A spontaneous report was received from a nurse concerning a 49 year old, female patient who received 2 doses of the vaccine in a fairly quick succession and experienced hives. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 09-FEB-2021, at approximately 9:29AM for prophylaxis of COVID-19 infection. A nurse from the Health Department stated that a patient called her complaining about receiving two doses of the Moderna Covid-19 vaccine too close together. The patient stated that the nurse who administered the vaccine to her stuck her, the patient felt a sting and jumped, and the nurse ended up sticking herself. The syringe was immediately discarded into the sharps container and the patient was given another dose of the vaccine. The patient was asked to wait for 10 minutes and as she was leaving, she noticed hives. But the next day when she called the nurse at the health department, she was better. Patient (PJ) is a 49-year-old female. Patient received the vaccine at her workplace RHA health. Action taken with mRNA-1273 in response to the event was not provided/unknown. The event, person who received 2 doses of the vaccine in a fairly quick succession, was considered recovered/resolved on 10-FEB-2021. The outcome of the event hives was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,02/09/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Occupational exposure to product', 'Urticaria']",2,MODERNA,OT 1053667,MS,77.0,F,"Passed out; A spontaneous report was received from a consumer concerning a 77-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient passed out. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273. Batch number not provided on an unknown date. On 09 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273: LOT 041L20A. intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 10 Feb 2021, She got up this morning and passed out while standing at the kitchen island for 2-3 minutes. She wants to know if she should be checked out. Treatment information was unknown. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/10/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Loss of consciousness'],2,MODERNA,OT 1053668,WA,,F,"swelling to head; swelling to left back knee; swelling to left hip; swelling to left foot; hit head; bump on back of the head; fainted; sleepiness; left arm pain; acute body aches; fatigue; flu like symptoms; A spontaneous report was received from a healthcare professional concerning a 65-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu like symptoms, acute body aches, sleepiness, fatigue, left arm pain, fainted, on blood thinner and worried about a cerebral bleed because she hit her head, bump on the back of the head, swelling to head, swelling to left back knee, swelling to left foot, and swelling to left hip. The patient's medical history was not provided. Concomitant medications included warfarin (5mg, 7.5mg). On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) in the right arm for prophylaxis of COVID-19 infection. On 05 Jan 2021, the patient experienced flu like symptoms which lasted 8 hours. On 02 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013M20A) in the left arm for prophylaxis of COVID-19 infection. On 02 Feb 2021, the patient reported experiencing acute body aches, sleepiness, fatigue, and left arm pain. On 03 Feb 2021, approximately at 3am, the patient fainted and was out for 10-15 mins. She is on blood thinner and is concerned about a cerebral bleed because she hit her head. On an unspecified date, the patient was experiencing swelling of left back knee, swelling of left foot, swelling of left hip and swelling of head. Treatment included paracetamol and ondansetron. Action taken with mRNA-1273 was not applicable as the subject had already received both scheduled doses. The events flu like symptom was resolved on 05 Feb 2021. The outcome for the events, acute body aches, sleepiness, fatigue, left arm pain, fainted, on blood thinner and worried about a cerebral bleed because she hit her head, bump on the back of the head, swelling to head, swelling to left back knee, swelling to left foot, and swelling to left hip were unknown.; Reporter's Comments: Based on the information provided, a causal association between the reported event of swelling of the head and mRNA-1273 use ids assessed as not related as swelling was due to subject hitting her head. Based on temporal association between the other reported events and mRNA-1273 use, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/05/2021,1.0,UNK,WARFARIN,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Fatigue', 'Head injury', 'Influenza like illness', 'Joint swelling', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Somnolence', 'Swelling', 'Syncope']",2,MODERNA,OT 1053669,NC,78.0,M,"Hallucinating; Urinary incontinence; Lack of awareness / became unaware and didn't know where he was; Lethargic; Couldn't find the bathroom; Couldn't get off the end of the couch; Temp of 102-103; A spontaneous report was received from a consumer concerning a 78-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced temperature of 102-103, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch. The patient's medical history was not provided. No concomitant medications were reported. On 20 Jan 2021, before the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient developed temperature of 102-103 degree fahrenheit, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch. The reporter stated that these side effects began approximately a day to two days prior to the vaccine. The treatment information included paracetamol. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, temperature of 102-103 degree fahrenheit, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch were unknown.; Reporter's Comments: This report concerns a 78--year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # not provided, and experienced temperature of 102-103, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch. Very limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/21/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Anosognosia', 'Body temperature', 'Dysstasia', 'Feeling abnormal', 'Hallucination', 'Lethargy', 'Pyrexia', 'Urinary incontinence']",1,MODERNA,OT 1053670,,,M,"erectile dysfunction; A spontaneous report was received from a consumer reporting on himself, a male of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced erectile dysfunction. The patient's medical history was not provided. Concomitant medication use was not provided. On 13Jan 2021, the patient received an unknown dose number of two planned doses of mRNA-1273 ([LOT number, route and location unknown]) for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced erectile dysfunction. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the erectile dysfunction was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Erectile dysfunction'],1,MODERNA,OT 1053671,TN,,F,"inability to stand or walk; slurred speech; inability to stand or walk; left sided pain in chest; left sided pain in chest, neck & scapular area; left sided pain in chest, neck & scapular area; elevated BP; lightheadedness; left hand started become cold & felt heavy; left hand started become cold & felt heavy; This is a spontaneous report from a contactable other health professional reporting for herself. A 48-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown), intramuscular (arm left) on 06Jan2021 17:45 (05:45 PM) at SINGLE DOSE for covid-19 immunisation. Medical history included endometriosis from an unknown date. The patient's concomitant medications were not reported. The patient did not take other vaccines in four weeks and no other medications were taken in two weeks. Patient did not have COVID prior vaccination. The patient was tested for COVID post vaccination (Unknown results in 2021). On 07Jan2021 11:30 (also reported as less than 24 hours post vaccination), the patient experienced left hand started becoming cold and felt heavy. On 08Jan2021 12:00 (reported as around noon), the patient experienced inability to stand or walk, elevated BP, slurred speech, lightheadedness; and left sided pain in chest, neck and scapular area. The patient was taken to urgent care and emergency room due to events left sided pain in chest, neck and scapular area, inability to stand or walk, elevated BP, slurred speech and lightheadedness. BP came to baseline by 1am (unspecified date in 2021). Treatment was given for the events. Outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Dysstasia, Dysarthria, and Gait inability cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Endometriosis,,,"['Arthralgia', 'Blood pressure increased', 'Blood pressure measurement', 'Chest pain', 'Dizziness', 'Dysarthria', 'Dysstasia', 'Gait inability', 'Limb discomfort', 'Neck pain', 'Peripheral coldness', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1053672,,42.0,F,"tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appetite; stomach cramping; headache; site soreness; dizziness; full body aches; chills; diarrhea; This is a spontaneous report from a non-contactable nurse who reported for herself, a 42-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021, at the age of 42 years, at a single dose for COVID-19 immunization. Medical history included depression. Patient had no cardiac history. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant, and not pregnant at time of vaccination. Concomitant medication included celecoxib (CELEXA). On 22Jan2021, the patient experienced extreme weakness, slept 36hrs, tachycardia up to 201, up to BP 210/101, nausea, no appetite, stomach cramping, headache, site soreness, dizziness, chest pain, full body aches, chills, and diarrhea. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported events including serious events hypertension, tachycardia, and chest pain were likely related to due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/22/2021,1.0,PVT,CELEXA [CELECOXIB],,Medical History/Concurrent Conditions: Depression,,,"['Abdominal pain upper', 'Asthenia', 'Blood pressure measurement', 'Chest pain', 'Chills', 'Decreased appetite', 'Diarrhoea', 'Dizziness', 'Headache', 'Heart rate', 'Hypersomnia', 'Hypertension', 'Nausea', 'Pain', 'Tachycardia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1053673,CA,70.0,F,"did I have a heart attack. No doctor will see me to give me an EKG; Collapsed; Crushing chest pain; chest was killing me and hurting and I was sobbing and it lasted about an hour and 15 minutes; Side of my neck hurt; My back hurt; It was just awful; Lethargic; I ended up vomiting for 2 days after the chest pain receded; slept for 16 hours; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 2 patients (husband and wife). This case refers to the wife with serious adverse events. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982, expiration was not reported), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. Medical history included acid reflux. Concomitant medication included dexlansoprazole (DEXILANT) for acid reflux. Patient reported that she had terrible severe reaction on the 22Jan2021. They were vaccinated on the 18Jan2021 and on the night of the 22Jan2021, she had such crushing chest pain that she just collapsed. Her chest was killing her and hurting and she was sobbing and it lasted about an hour and 15 minutes. The side of her neck hurt and her back hurt. It was just awful. Patient reported that she have called everybody. She have called her doctor's assistant and she confused her. Patient reported that they just went in because they were 70 and 71 and got the vaccine but then she ended up vomiting for 2 days after the chest pain receded and they took baby aspirin and then she just vomited and vomited and slept for 16 hours. They were both very lethargic. She asked her what should she do. She does not know if this was a reaction to the vaccine or did she have a heart attack. No doctor will see her to give me an EKG. They say they are not seeing patients. The patient recovered from chest pain on an unspecified date; while outcome of the remaining events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021115775 same reporter/drug, similar event, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/22/2021,4.0,OTH,DEXILANT,,Medical History/Concurrent Conditions: Acid reflux (esophageal),,,"['Back pain', 'Body height', 'Chest pain', 'Hypersomnia', 'Investigation', 'Lethargy', 'Myocardial infarction', 'Neck pain', 'Syncope', 'Vomiting']",1,PFIZER\BIONTECH, 1053692,MA,80.0,F,"My mother received her vaccine at 12:40 on 2/2. She waited longer than the fifteen minutes and she seemed fine. We left the facility and on the way home, approximately 45 after she received the vaccine, she began slurring her words ands was confused. The slurring lasted for 2-3 minutes The confusion continued. I brought her the ER where she was immediately taken in for a CT Scan. She later had an MRI, and met with a Cardiologist. She later had an EEG at the request of a Neurologist. She spent three nights in the hospital. All tests showed no acute signs of stroke, etc.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/02/2021,02/02/2021,0.0,PVT,Many,High BP Diabetes High Cholesterol,Bronchitis,,,"['Cerebrovascular accident', 'Computerised tomogram', 'Confusional state', 'Dysarthria', 'Electroencephalogram', 'Magnetic resonance imaging']",UNK,MODERNA,IM 1053693,OR,37.0,F,Swelling of different areas throughout my body and hives,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/20/2021,2.0,PUB,None,None,None,,Cats,"['Swelling', 'Urticaria']",2,MODERNA,SYR 1053694,TX,62.0,M,Sudden Death on 2/17/2021,Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/17/2021,9.0,UNK,"Tamsulin, Xarelto, Lasix","A-FIB, DM2,","DM2, A-FIB",,NKDA,['Sudden death'],1,MODERNA,IM 1053695,UT,44.0,F,"After dose 1 of the Moderna vaccine on day 7 I got a severe headache, nausea and vomiting After dose 2 of the Moderna vaccine the following morning I had a severe headache, nausea, vomiting, and major body aches. I also had severe stabbing stomach pain, sweating, vomiting and pain in my back. Day 2-6 most of the symptoms cleared up except the headache and stabbing stomach pain. I am currently on day 6 and I have severe stomach pain every time after I eat food. I am going to see a gastro doctor to rule out gallbladder inflammation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,SCH,"Omeprezole, multi-vitamin, ibuprofen",,,,,"['Abdominal pain upper', 'Back pain', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pain', 'Vomiting']",2,MODERNA,SYR 1053696,GA,72.0,F,"Mid afternoon on Wednesday, February 24, 2021, I developed a headache, severe chills, body aches, queasiness, and I felt very tired. I am currently running a 101 temperature and feel Ike terrible",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/24/2021,1.0,OTH,"Castrates, Vision Formula 50+, Centrum Silver Women 50+, Krill Oil 500mg, Cranberry Capsules 500mg, Estradiol .5mg",None,None,,No,"['Chills', 'Headache', 'Pain']",2,PFIZER\BIONTECH,IM 1053697,MN,61.0,F,"unable to thermoregulate, headaches, muscular aches, severe tiredness, swollen lymph glands under arm on left side",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/23/2021,0.0,OTH,"progestin, estradiol","none; Covid onset about January 5, 2021",none,,none known,"['Fatigue', 'Headache', 'Lymphadenitis', 'Myalgia']",1,MODERNA,SYR 1053698,CA,,F,"1/27/21 Vaccine 9:45 injection - mederma 10:09 eyelids itching - declined Benadryl 10:30 end of observation @ clinic 11:15 Intense itching eyes face lip 11:15 Benadryl50 mg po 11:20 Itching spread to entire face/ ears / roof of mouth / sore throat / ear pain / eye pressure 11:40 symptoms decreased to mild 12:00 symptoms resolved 15:30sore throat tight/ ear pain returning/ eye pressure 15:45 Benadryl 50mg po 21:00 throat sore/ tight- eye pressure 21:30 Benadryl 50mg 1/28/21 1:11 tight cough /sore throat/ ear pain / itchy ears / scalp 1:11 Benadryl 50 mg po 7:00 rash on chest / sore throat/ tight throat/ itchy ears, face chest 8:30 Benadryl 50mg po 12:30 eye pressure/ ear pressure /ear pain/ sore throat / cough 12:40 Benadryl 50 mg po 17:00 eye pressure/ ear pressure /ear pain/ sore throat / cough 17:30 Benadryl 50 mg po 21:30 eye pressure/ ear pressure /ear pain/ sore throat / cough 21:30 Benadryl 50 mg po 1/29/21 Symptoms continue - Benadryl 50 mg po q4 hrs 1/30/21 Symptoms continue - Benadryl 50 mg po q4 hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,PVT,Zyrtec Xopenex,,Allergy induced Asthma,Tetanus Toxoid- Age 6mo anaphylaxis Hep B - mild rash age29,"Allergic to penicillins , tetanus toxoid, keflex, albuterol, ibuprofen , corticosteroids, walnuts, peanuts, melon, aspartame, msg, dust, mold, cockroaches, pine trees, ragweed","['Cough', 'Ear congestion', 'Ear pain', 'Ear pruritus', 'Eyelids pruritus', 'Oropharyngeal pain', 'Pruritus', 'Throat tightness']",1,MODERNA,SYR 1053699,FL,24.0,F,"Adverse Event: pt felt swelling in throat area (same that occurs when pt drinks alcoholic beverage). Side of tongue felt numb. Pt felt like something was stuck in back of throat. No dizziness, no trouble breathing. No GI symptoms. No swelling or hives at site injection. Treatment: 12.5mg IV Benedryl; 60mg IV Solumedrol Outcome: Swelling went down in throat. Tongue no longer numb. Pt sent home with Epipen for emergencies.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,PVT,None,,,,"Allergic to ingested Alcohol PO (hives, throatal swelling)","['Hypoaesthesia oral', 'Pharyngeal swelling']",1,PFIZER\BIONTECH,IM 1053700,NY,64.0,F,"initial event: 7am morning after injection- fever, heaviness of limbs, sleeping, eyes sensitive to light. 2nd morning after, these symptoms subsided, but swelling and sensitivity in axillary lymph nodes, especially on right side. This has continued for 18 days. At 14 days, severe outbreak of herpes simplex. First such outbreak after 30 years of no recurrence, and no concurrent triggers such as menstruation, alcohol consumption, sexual intercourse, etc",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/08/2021,1.0,PVT,"Calcium/magnesium (advacal), vitamin D, Silica (BioSil), Zyflamend (turmeric/ginger etc)",na,na,,"penicillin, pollens, molds","['Herpes simplex', 'Limb discomfort', 'Lymphadenitis', 'Photosensitivity reaction', 'Pyrexia', 'Somnolence']",2,MODERNA,IM 1053701,WA,71.0,F,"Almost immediately after the injection the site started to itch, not severe but an itch that compelled me to scratch it. Today is day 2 and tho not constant, the desire to touch/scratch the site is quite strong. There?s a hardness and some swelling in the area , a bit warm to the touch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/23/2021,0.0,OTH,Simvastatin 40mg Anastrozole 1 mg,,,,Amoxicillin,"['Injection site induration', 'Injection site pruritus', 'Injection site swelling', 'Injection site warmth']",2,MODERNA,SYR 1053704,VA,90.0,F,"Patient says she felt well after getting the vaccine, but shortly before midnight the same day started feeling fatigue, body pain all over. Next day pain was improved; only remaining jaw pain and fatigue; then the day after pain resolved but persistent fatigue and SOB since then (for 13 days now). Severe dyspnea on exertion; baseline able to walk more than 5 minutes before getting tired; over last 13 days unable to walk from one room to another without severe SOB> Had a ride today so came to urgent care for evaluation. Patient found to be in atrial fibrillation with rapid ventricular rate at 140",Not Reported,,Not Reported,Yes,,Not Reported,N,02/12/2021,02/12/2021,0.0,PVT,none,none,HTN - pt was not taking medication that she was prescribed,,Penicillin Neosynephrine,"['Atrial fibrillation', 'Brain natriuretic peptide increased', 'Cardiomegaly', 'Chest X-ray abnormal', 'Dyspnoea', 'Dyspnoea exertional', 'Fatigue', 'Gait inability', 'Pain', 'Pain in jaw', 'Pulmonary oedema']",2,MODERNA,IM 1053729,WA,55.0,F,"Cardiac dysrhythmia. Paxoxsymal A-fib, atrial tachycardia.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/21/2021,01/22/2021,1.0,PVT,estradiol,none,none,,NKDA,"['Arrhythmia', 'Atrial fibrillation', 'Atrial tachycardia', 'Electrocardiogram abnormal', 'Full blood count normal', 'Laboratory test normal', 'Troponin normal']",1,PFIZER\BIONTECH,IM 1053758,TX,58.0,F,"Systemic: Brain aneurysm-Severe, Systemic: Headache-Severe",Yes,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,SEN,,,,,,"['Headache', 'Intracranial aneurysm']",2,PFIZER\BIONTECH,IM 1053776,MN,68.0,F,"They only gave her 0.3 and gave her second shot containing 0.2 three hours later; Soreness in her upper arm; Slight headache; A spontaneous case report was received from a consumer concerning herself, a female patient age 68, who experienced a medication error when she was vaccinated with Moderna Covid-19 Vaccine (mRNA-1273) . She also reported, ""some soreness"" in her arm and a ""slight"" headache. The patient's medical history included a report of ""heart issues"" . No other medical history was provided. Concomitant product use was not provided. On 08-Feb-2021, (time not provided), prior to the onset of events, the patient received her first dose of mRNA-1273, Lot number 024m20A, intramuscularly into her left arm. At some time later the same day the patient received a call from the vaccine clinic. The patient stated, ""The people who were conducting the vaccine clinic said I should return because I was given the wrong dose"" The patient stated that upon her return to the clinic on 08-Feb-2021, she asked a lot of questions. She was informed that the nurse had given her 0.3 and she should have given her 0.5. She was ""not sure if it was milliliters or what"". Some 3 hours after receiving the first wrong dose of 0.3, the patient reported receiving a second injection of 0.2 IM. The patient did not report the site where the second dose was administered or whether the lot number was different. The patient reported that she developed ""some soreness"" in her arm and a ""slight headache"" when she went to bed on 08-Feb-2021. She reported the headache had resolved when she awoke on 09-Feb-2021. No treatment information was provided regarding her arm soreness or her headache. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the events Product administration error and Pain in extremity were considered unknown. the event Headache was considered resolved. Company comment: the reported events Product administration error was considered not applicable with regard to mRNA-1273. The events Pain in extremity and Headache were considered possibly related to mRNA-1273.; Reporter's Comments: This report refers to a 68 Y/O female who had an NS unexpected event of Product administration error (mRNA-1273 lot # unknown) with NS unexpected pain in extremity and NS expected headache. Event onset the same day as second dose mRNA-1273. Reporter stated that 3 hours after first wrong dose of 0.3, she had a second dose of 0.2 IM. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,UNK,,,"Medical History/Concurrent Conditions: Cardiac disorder (Patient reported ""heart issues"")",,,"['Headache', 'Pain in extremity', 'Product administration error']",2,MODERNA,OT 1053777,CT,78.0,M,"arm became really itchy around injection site; thought it be cellulitis; whole arm around injection site was swollen up like a balloon; whole arm around injection site was red; doses given 14 days apart; very nervous; became nauseas; ended up throwing up; very low fever 100F; just tired; This spontaneous report was received 10FEB2021 from a consumer which refers to a 78-year-old male patient who received the Moderna COVID-19 (mRNA-1273) Vaccine and experienced nausea, vomiting, tired, itchy around injection site, arm swelling at injection site, arm red around injection site, first and second dose were given 14 days apart. The patient's medical history included current cancer, dermatomyositis (autoimmune disease), Concomitant medications included chemotherapy (Keytruda infusion). On 15JAN2021, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 intramuscularly (Lot number: 039K20A). On 29JAN2021, the patient received the second of two planned doses of mRNA-1273 intramuscularly (Lot number: 028L20A). Doses were given 14 days apart, out of window 15 days early. The event(s) were, "" injection site soreness, fever he became nauseas, ""I never get nauseas"", ended up throwing up, very low fever 100F, tired, the arm became really itchy around injection site, whole arm around injection site was swollen ""up like a balloon"" whole arm around injection site was red, first and second dose were given 14 days apart"". The action taken for Moderna COVID-19 Vaccine was reported as taking Tylenol after the first vaccine injection for fever and Amoxicilin after second shot, 1x1000mg. The outcome of the events was reported as Resolved.; Reporter's Comments: This report refers to a 78 Y/O male with Inappropriate schedule of vaccine administered (second dose at 2 week interval) for mRNA-1273 (lot # unknown) with serious unexpected cellulitis 5 days after second dose and NS Vaccination site pruritus, vaccination site erythema, vaccination site swelling, fatigue, fever, nausea, vomiting. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,UNK,,"Cancer (Cancer; type unknown . Taking chemotherapy (Keytruda infusion) as Treatment. Med Hist dates not provided.); Dermatomyositis (dermatomyositis (autoimmune disease), Med Hist dates not provided.)",,,,"['Cellulitis', 'Fatigue', 'Inappropriate schedule of product administration', 'Nausea', 'Nervousness', 'Pyrexia', 'Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site swelling', 'Vomiting']",2,MODERNA,OT 1053778,IL,,F,"Vertigo; Dizzy; Lightheaded; Get really bad; Feels uneasy; A spontaneous report was received from a consumer, a 78-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273), and who experienced vertigo, dizzy (dizziness), lightheaded (dizziness), get really bad (malaise), and feels uneasy (malaise). The patient's medical history was not provided. Concomitant medication use was not provided. On 25 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) for prophylaxis of COVID-19 infection. On 1 Feb 2021, the patient started to ""get really bad"". The room was spinning (vertigo) and she was also dizzy and lightheaded. On 02 Feb 2021, the patient still had the same symptoms. It was reported that the patient was evaluated and spent one day in the hospital. On 10 Feb 2021, the patient reported that every once in a while, she is lightheaded and feels uneasy. Treatment for the event included meclizine. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, vertigo, dizzy, and get really bad, was unknown. The outcome of events of lightheaded and feels uneasy was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/25/2021,02/01/2021,7.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Dizziness', 'Malaise', 'Vaccination complication', 'Vertigo']",1,MODERNA,OT 1053779,NC,,F,"Fatigue; Fever; Headache; Passed out; Tachycardia; Shacking; High blood pressure; Breathing issue; A spontaneous report was received from a female patient, unknown age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed out, tachycardia, shaking, experienced high blood pressure, breathing issues, fatigue, fever, and headache. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. The patient reported that a fewminutes after receiving the Moderna vaccine shot, she passed out, was shacking, had high blood pressure, and breathing issue. Emergency services (911) was called and the patient was transported to the hospital. The patient recovered after an hour, but since has been feeling fatigue, fever, and headache time to time. No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the event was not reported. The events passed out, tachycardia, shaking, high blood pressure, and breathing issues were considered recovered/resolved on 04 Feb 2021. The outcome of the events fatigue, fever, and headache were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/04/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Dyspnoea', 'Fatigue', 'Headache', 'Hypertension', 'Loss of consciousness', 'Pyrexia', 'Tachycardia', 'Tremor']",1,MODERNA, 1053780,CA,,M,"heart fibrillations; heart fibrillations; A Spontaneous report was received from a Consumer, concerning a 65-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart fibrillations. The patient's medical history was not provided. Concomitant medications included: warfarin sodium, benazepril and pantoprazole. On 12-JAN-2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (lot number: 025L20A) at unknown site of administration and unknown route for prophylaxis of COVID-19 infection. On 22-JAN-2021, the patient experienced heart fibrillation. On 23-JAN-2021, the patient had recovered from heart fibrillation. On 8-FEB-2021, the patient again had experienced heart fibrillation and went to the emergency room (ER), the patient had recovered from heart fibrillation on the same day. The event of heart fibrillations was assessed as medically significant. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, heart fibrillation was considered as resolved.; Reporter's Comments: Very limited information regarding the events of cardiac fibrillation has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/22/2021,10.0,UNK,COUMADIN; BENAZEPRIL; PANTOPRAZOLE,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Cardiac fibrillation'],1,MODERNA, 1053788,TN,93.0,F,Received call that patient is now deceased,Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/15/2021,13.0,PUB,None reported,None reported,None reported,,None reported,['Death'],1,MODERNA,IM 1053824,NJ,,F,"severe abdominal pain; This is a spontaneous report from a contactable consumer. A 23 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date. On an unspecified date within 48 hours after vaccination patient presented severe abdominal pain resulting in an hospital visit. At the time of the reporting event outcome was unknown. Information about Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Abdominal pain'],2,PFIZER\BIONTECH, 1053825,VA,91.0,F,"very acute confusion; marked confusion; never had it before; completely out of character; This is a spontaneous report from a contactable Nurse (patients daughter). A 91-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 05Feb2021 at 14:30 PM (at the age of 91-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), in Jan2021 for COVID-19 immunization and experienced minor soreness and nausea; the Flu vaccine and experienced aches, chills, fever, and once even had a red streak up and down the injection site arm. On 05Feb2021, immediately after received the second shot, the patient experienced very acute confusion; marked confusion, that lasted about an hour; she had never had it before; it was also reported that it was completely out of character. The nurse informed that her mother had never had marked confusion before and since it did pass, the nurse feels it's medically significant. It was reported that the patient was observed for 15 minutes and then got up and went back to her apartment. In that period of time when in there, no one noticed what happened in that few minutes. The nurse reported her mother's neighbor was who called her. The nurse was on the way to pick up her mother anyway because she knew there was always a chance of side effects with older people. The nurse had just driven up within that 15 minutes when the neighbor called stating the patient was confused. This was completely out of character for her. When she picked up her mother she took her to the emergency room which is maybe 20 minutes away and didn't have the petal to the metal. On the way to emergency room could see her mother starting to clear up. She had her down in the car in about 10 minutes, 20 minutes driving to emergency room, so a total of 45 minutes to hour. They asked questions and within the hour her mother was okay, it was scary. The clinical outcome of very acute confusion and completely out of character was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the events ""acute confusion; marked confusion, that lasted about an hour; she had never had it before; it was also reported that it was completely out of character"" with BNT162b2 can not be completely exclucded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,SEN,,,,,,"['Confusional state', 'Personality change']",2,PFIZER\BIONTECH, 1053826,FL,78.0,F,"freezing to death; Chills; Fever; Headache; I was just really kind of blah, just didn't feel good at all; I just kind of feel, I am blah, I am tired; I was just really kind of blah, just didn't feel good at all; I just kind of feel, I am blah, I am tired; I have mouth full of fever blisters; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on 06Feb2021 (at the age of 78-years-old) at single dose for COVID-19 vaccination. Medical history included blood pressure and heart disorder. Concomitant medications included metoprolol succinate (TOPROL XL) for heart medicine and hydrochlorothiazide/losartan potassium (LOSARTAN/HCTZ) for blood pressure. Historical vaccine included BNT162B2 for COVID-19 vaccination on an unknown date and had no problems with the first shot. On 06Feb2021, the patient experienced freezing to death; chills; fever; headache; was just really kind of blah, just didn't feel good at all; I just kind of feel, I am blah, I am tired; mouth full of fever blisters. Treatment for the events freezing to death, chills, headache, feeling bad, tired included acetaminophen (TYLENOL). The outcome of the events freezing to death, chills, headache, feeling bad, tired and mouth full of fever blisters was unknown. The outcome of the event fever was recovered in Feb2021. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/06/2021,0.0,UNK,TOPROL XL; LOSARTAN/HCTZ,,Medical History/Concurrent Conditions: Blood pressure high (Verbatim: Blood pressure); Heart disorder,,,"['Chills', 'Fatigue', 'Feeling abnormal', 'Feeling cold', 'Headache', 'Oral herpes', 'Pyrexia']",2,PFIZER\BIONTECH,OT 1053879,,67.0,F,Shortness of breath - related to chronic comorbidities,Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,,01/20/2021,01/30/2021,10.0,UNK,,Esophageal Cancer with Radiation and Chemotherapy. Patient chose to stop treatment,"Malignant neoplasm of the breast, Esophageal cancer, CAD,",,,['Dyspnoea'],UNK,PFIZER\BIONTECH, 1053907,OH,52.0,M,"22 hours after receiving the vaccine, I had fever and the chills. This was followed by a headache. This was not unexpected. I fell into a deep sleep that lasted 2 hours. I awoke suddenly with a very bad headache. I drank about 3 ounces of orange juice and then took 30 ml of pharmacy brand liquid Tylenol. This is the bad symptom that I want to report. As soon as the liquid Tylenol hit the back of my throat it felt as if my throat constricted tightly. I immediately stopped drinking it and was able to spit out some of what was in my mouth. I was unable to get air in or out. I stood up and eventually was able to get a big gulp of air into my lungs before everything closed up again. Eventually I was able to get another gulp of air in and I began to cough a little. Once I drank some water, I could feel the liquid Tylenol on the back of my throat get washed down and I was able to breath normally in about 2 minutes. The cup of liquid Tylenol still had about 20 ml of fluid in it and I spit out perhaps half of what entered my mouth; I'm estimating that 5 ml of liquid Tylenol went down my throat. Note that this is not a case of the liquid Tylenol going down my windpipe by mistake. I know what that feels like and it is different. It was all very traumatic.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,SCH,none,none,obesity,,poison ivy,"['Chills', 'Cough', 'Dyspnoea', 'Headache', 'Pyrexia', 'Respiration abnormal', 'Throat tightness']",1,MODERNA,IM 1053925,AL,62.0,F,"bulging on her side; pain/It hurts; symptoms of acute pancreatitis; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Feb2021 at single dose in left arm for COVID-19 immunisation at the age of 62-year-old. Lot number was EN3318, expiration date 31Mar2021. Relevant medical history and concurrent conditions included ongoing Primary immunodeficiency syndrome, ongoing lupus, ongoing Type 2 diabetes since 2001, sleep disorder. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date at single dose for COVID-19 immunisation (lot number was lot number EJ1686 or EJL1686). Past drug history included HIZENTRA for Immune system disorder (for years). Concomitant medications included ongoing sitagliptin phosphate (JANUVIA) for Type 2 diabetes, ciprofloxacin, trazodone and alprazolam for sleep disorder, methocarbamol as muscle relaxant. On 06Feb2021, the patient experienced symptoms of acute pancreatitis. The patient has spoken to a Doctor and a Nurse practitioner. The patient refused to go to the hospital. She was drinking an incredible amount of fluids, and she was taking stuff for pain. The patient took Tramadol too, but it did not do anything; it did not ease any pain; she did not seem to respond to it. The patient was bulging on her side, it hurt. The patient did not recover from acute pancreatitis, the outcome of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,UNK,JANUVIA [SITAGLIPTIN PHOSPHATE]; CIPROFLOXACIN; TRAZODONE; ALPRAZOLAM; METHOCARBAMOL,Lupus erythematosus; Primary immunodeficiency syndrome; Type 2 diabetes mellitus,Medical History/Concurrent Conditions: Sleep disorder,,,"['Pain', 'Pancreatitis acute', 'Swelling', 'Weight']",2,PFIZER\BIONTECH, 1053944,MI,50.0,F,"Started 2/15 with joint pain. On 2/20 started with high fever, chills and headache, frequent urination and dehydration. On 2/22 started to vomit continued with other systems. Went to emergency clinic. They thought it was a UTI and prescribed an antibiotic. Antibiotics not working. Admitted to hospital on 2/23. All above symptoms continues. Met with internal dr and infectious disease dr. They believe this is a bladder infection plus a virus. Have been in hospital for three days now. Dr ordered more labs and waiting on outcome.",Not Reported,,Yes,Yes,3.0,Not Reported,N,01/28/2021,02/20/2021,23.0,PUB,,,"Obesity, migraines",,,"['Arthralgia', 'Blood culture negative', 'Chest X-ray normal', 'Chills', 'Cystitis', 'Dehydration', 'Headache', 'Laboratory test', 'Pollakiuria', 'Pyrexia', 'Vomiting', 'X-ray limb']",2,PFIZER\BIONTECH, 1053958,CA,69.0,M,"Severe hemolytic anemia, drop in hemoglobin and red blood cells. Needed two units blood transfusion at Hospital 2/16-22/18 2021. Released under prednisone prescription",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/01/2021,02/07/2021,6.0,OTH,"Omeprazole, Rosuvastatin, Centrum, Lutein, Fish Oil",None,"Stage 0, Chronic Lymphocytic Leukemia since 2015",,None,"['Haemoglobin decreased', 'Haemolytic anaemia', 'Red blood cell count decreased', 'Transfusion']",1,MODERNA,IM 1053973,NJ,36.0,F,"Wife did not know she was pregnant at the time, had the vaccine and miscarried the child at 12 weeks. OBGYN stated baby had miscarried 2-3 weeks earlier. D&C procedure performed 2/23 to remove remains of fetus.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,12/16/2020,02/15/2021,61.0,PVT,none,none,none,,none,"['Abortion spontaneous', 'Exposure during pregnancy', 'Uterine dilation and curettage']",1,MODERNA,IM 1053978,GA,77.0,F,"pt woke up at 0400 with fever, chills, and body aches progressing over 4 hours to the point when she became unresponsive. husband called 911, pt was declared dead at the time of EMS arrival around 1200",Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/24/2021,1.0,PVT,"Albuterol sulfate inhaler, atenolol, ipatropium-albuterol nebulizer, Sensipar, lisinopril, Incruse Ellipta, lovastatin, pantoprazole, furosemide, trazodone, diclofenac gel, triamcinolone cream, fluticasone nasal spray",none,"CKD Stage 3, COPD, hyperlipidemia, secondary hyperparathyroidism",,NKDA,"['Chills', 'Death', 'Pain', 'Pyrexia', 'Unresponsive to stimuli']",2,MODERNA,IM 1054006,MO,76.0,F,"patient reported feeling faint, got lightheaded, dizzy, nauseated",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/24/2021,02/24/2021,0.0,PUB,not listed,unknown,unknown,,none listed,"['Dizziness', 'Electrocardiogram QRS complex abnormal', 'Electrocardiogram QRS complex prolonged', 'Hypertension', 'Nausea', 'Sinus rhythm']",1,PFIZER\BIONTECH,IM 1054045,WI,86.0,F,Chest pain,Not Reported,,Not Reported,Yes,,Not Reported,U,02/23/2021,02/23/2021,0.0,PHM,"Lisinopril 40 mg QD, Metoprolol tartrate 25 mg BID, Atorvastatin 40 mg QD, Potassium Cl ER 20 mEq QD, Ketorolac 0.5% eye drop QD right eye, Ipratropium/albuterol 0.5/3(2.5) mg QID, Umeclidinium 62.5 mcg inhaler, Oxycodone 10 mg PRN, Nitrogl",,"COPD, essential hypertension, mixed hyperlipidemia, CKD stage 3, atrial fibrillation, atherosclerotic heart disease of coronary artery",,NDKA,"['Chest pain', 'Troponin increased']",2,PFIZER\BIONTECH,IM 1054060,FL,67.0,F,"A lot of liquid running down the front and back of her arm; concerned there was a leak around the hub around the needle; concerned there was a leak around the hub around the needle; A spontaneous report was received from a consumer, who was also a 67-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273). There was a lot of liquid running down the front and back of arm (exposure via skin contact) and the patient was concerned that there was a leak around the hub around the needle (device connection issue, underdose). The patients' medical history was not provided. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (batch number: 013L20A) on 16 Jan 2021. On 13 FEB 2021 at 1 pm, the patient received their second dose of mRNA-1273 (batch number: 039K20A) for prophylaxis of COVID-19 infection. During the second dose, there was a lot of liquid running down the front and back of the patient's arm. She was concerned that there was a leak around the hub around the needle. The patient asked if she would have the same immunity effect if she did not receive the full second dose. Treatment information was not provided. The action taken with mRNA-1273 in response to the events was not applicable. The events, there was a lot of liquid running down the front and back of arm and concerned that there was a leak around the hub around the needle, were considered recovered/resolved on 16 Feb 2021.; Reporter's Comments: This report refers to a case of Underdose due to a leak around the hub around the needle for mRNA-1273, lot # 039K20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/16/2021,02/13/2021,28.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Device connection issue', 'Exposure via skin contact', 'Underdose']",1,MODERNA, 1054061,PA,,F,patient received less than half the dose; experienced a needle and syringe detached; A spontaneous report was received from a physician concerning a patient who experienced a needle and syringe detached and patient received less than half the dose. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the event(s) was not reported.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (no medical history reported),,,"['Device connection issue', 'Underdose']",1,MODERNA,OT 1054062,FL,81.0,F,"Received another Moderna dose two days later; A spontaneous report was received from a consumer regarding his wife, an 81-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and then accidentally got the dose again two days later/inappropriate schedule of vaccine. The patient's medical history included Alzheimer's Disease. Concomitant medications were reported as unknown Alzheimer's drugs. On 17 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 19 Jan 2021, the husband reported that the patient wandered off and received a second dose. Lot number for second dose reported as 013L20A. Treatment information was not provided. Action taken with mRNA-1273 was not applicable. The outcome of the events, patient accidentally received the first dose twice, is reported as resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot number 013L20A for second dose) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/17/2021,01/19/2021,2.0,UNK,,,Medical History/Concurrent Conditions: Alzheimer's disease,,,['Inappropriate schedule of product administration'],2,MODERNA,OT 1054063,,,F,"now bump is from shoulder to elbow; looks bruised in the middle; dark outline of red; was itchy; burned; cellulitis; big red bump; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis (vaccination site cellulitis), big red bump (vaccination site reaction), bump is from shoulder to elbow (peripheral swelling), burned (vaccination site pain), looks bruised in the middle (vaccination site bruising), dark outline of red (erythema), and was itchy (vaccination site pruritis). The patient's medical history was not provided. No relevant concomitant medications were reported. On 03 Feb 2021 the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 10 Feb 2021, The patient experienced vaccination cellulitis (big red bump) and pruritus (itchy) with seriousness criteria of hospitalization Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event is unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,02/10/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Erythema', 'Peripheral swelling', 'Vaccination site bruising', 'Vaccination site cellulitis', 'Vaccination site pain', 'Vaccination site pruritus', 'Vaccination site reaction']",1,MODERNA, 1054080,MI,67.0,M,"cardiac arrest, death: 2/21/21",Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/21/2021,3.0,PHM,"amlodipine, centrum silver, vitamin C, Vitamin D, vitamin E, zinc, Lexapro, Seroquel, trazodone.",none,"hypertension, COPD, schizophrenia",,NKDA,"['Cardiac arrest', 'Death']",UNK,MODERNA, 1054114,IL,102.0,F,Patient was hospitalized 15 days after receiving vaccine. Admission was not due to vaccine and was admitted for acute ascites and patient had reported fever and hypoxia. Patients admission resulted in death 7 days after being admitted to hospital.,Yes,02/01/2021,Not Reported,Yes,,Not Reported,N,01/27/2021,02/22/2021,26.0,SEN,,,,,NKDA,"['Ascites', 'Death', 'Hypoxia', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1054116,AL,49.0,F,"My left arm was very sore , red and hurting pretty bad. I went to bed around 10:00pm thinking everything was ok and it was a normal reaction. Woke up around 1:30am arm hurting so I got up to get some more tylenol. I immediately felt sick to my stomach (both ways) and I passed out and broke my nose. I was coherient at times and other times I could not seem to answer any questions. My husband got me to the ER and they took my blood pressure 4 or 5 times and the nurse said ""I can't get a blood pressure"". Another nurse came in and said we will take this one ! My blood pressure had bottomed out and caused all sorts of things going on. I left ER after 4 1/2 hrs. with a BP of 107/57 but I am not sure how low it got! At one point my husband looked at monitor and my bottom number was 39 but it is all a blur to me. As of today I still feel week (heavy arms) and I am concerned about taking my second dose!",Not Reported,,Yes,Yes,,Not Reported,U,02/17/2021,02/18/2021,1.0,PHM,"Welbutrin, nexium, zinc, vit. C, multi-vitamin, thyroid med.",,,,,"['Asthenia', 'Blood pressure decreased', 'Erythema', 'Facial bones fracture', 'Incoherent', 'Limb discomfort', 'Loss of consciousness', 'Malaise', 'Pain in extremity']",1,MODERNA,SYR 1054124,MD,73.0,M,"2/24/21 patient was admitted after a cath lab procedure; reason for admission: chest pain per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine This hospitalization does not appear to be related to the vaccine",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/19/2021,02/24/2021,5.0,PVT,,,,,,['Chest pain'],2,MODERNA,IM 1054128,OH,30.0,M,"Patient lives with family in private residence with parents and 2 siblings. Spends most of time in own room. First family member diagnosed with COVID-19 on 12/21 2020, the other 3 family members diagnosed with symptomatic mild COVID on 12/26/2020. Parents are healthcare providers and used specific informed diligent protective strategies to prevent infection in patient with minimal close contact and gloves, masks. Patient never had symptoms and was not tested for COVID.. Had first vaccine dose on 1/16. On 1/17 had shaking chills with temp to 101.3F, gone on 1/18.. No other overt reactions. Subsequently in usual state of health. On 2/15 he developed vomiting and fever with progressive abdominal pain and transient wheezing. Outpatient testing for SARS-CoV2 was negative and full respiratory pathogen panel (including SARS-CoV2) also negative. With worsening fever to 40.2C and abdominal pain, was admitted on 2/18. Found to have high leukocyte count, low lymphocyte count and transaminitis. CT imaging with terminal ileitis, thought possibly infectious but extended GI pathogen panel negative. Experienced persisting daily high grade fevers to up to 39.1.C. Developed transaminitis and hypotension and was transferred to intensive care unit on 2/21. Was intubated for hypoxia, agitation, required levophed, large volume resuscitation and empiric antimicrobials. Had transient AKI. Antimicrobials stopped on 2/22 with negative cultures. Colonoscopy performed with leal biopsy of identified ulcerative disease with focal active enteritis without specific etiology identified by stains. Ferritin rose to 24,000 with hypertriglyceridemia and thought to have possible HLH and underwent bone marrow biopsy which showed leukocytosis and lymphopenia, and rare hemophagocytosis. Dobutamine was started for low LVEF and levophed weaned. High dose dexamethasone started on 2/23 and pressor further reduced, dobutamine weaned to off on 2/25. Extubated on 2/24. Febrile still to 39 on 2/24 and with leukocytosis but transaminases, ferritin and triglycerides improving. Discussion ongoing about HLH vs macrophage activation syndrome. Currently meets 4 criteria for HLH with soluble IL-2R and NK activity pending.",Not Reported,,Yes,Yes,7.0,Not Reported,N,01/16/2021,02/15/2021,30.0,PVT,Albuterol Memantine Naltrexone Synthroid Venlafaxine PredForte eye drops Clobetasol topically Miralax,No acute illnesses,Trisomy 21 Celiac disease Obstructive sleep apnea Reactive airways disease Hypothyroidism--Hashimoto's thyroiditis Non-alcoholic hepatic steatosis Vitamin D deficiency Depression/Anxiety Sensorineural hearing loss Psoriasis Keratoconus with cornea transplants Chronic constipation,,Cephalosporins (hives) Gluten,"['Abdominal pain', 'Abscess intestinal', 'Acute kidney injury', 'Agitation', 'Alanine aminotransferase increased', 'Anisocytosis', 'Aspartate aminotransferase increased', 'Atrial fibrillation', 'Biopsy bone marrow abnormal', 'Biopsy colon abnormal', 'Biopsy small intestine', 'Blood bilirubin increased', 'Blood creatinine normal', 'Blood culture negative', 'Blood triglycerides increased', 'Body temperature increased', 'C-reactive protein increased', 'Chills', 'Colitis ulcerative', 'Colonoscopy abnormal', 'Computerised tomogram abdomen', 'Computerised tomogram thorax normal', 'Culture negative', 'Culture stool negative', 'Cytomegalovirus test negative', 'Ejection fraction decreased', 'Endotracheal intubation', 'Enteritis', 'Epstein-Barr virus test', 'Gastrointestinal pathogen panel', 'Gram stain', 'HIV test', 'Haemoglobin normal', 'Haemophagocytic lymphohistiocytosis', 'Hepatitis A antigen negative', 'Hepatitis B test negative', 'Hepatitis C test negative', 'Hypertriglyceridaemia', 'Hypotension', 'Hypoxia', 'Intensive care', 'Leukocytosis', 'Lymphocyte count decreased', 'Lymphopenia', 'Platelet count normal', 'Pyrexia', 'Respiratory viral panel', 'Retroperitoneal lymphadenopathy', 'SARS-CoV-2 test negative', 'Serum ferritin increased', 'Terminal ileitis', 'Transaminases increased', 'Tremor', 'Treponema test', 'Vomiting', 'Wheezing', 'White blood cell count increased']",1,MODERNA,IM 1054137,AZ,73.0,F,"COPD on 2L BL O2 requirement, hypothyroidism, cachexia, GERD with similar presentation earlier this month post-covid vaccine # 1, who presetned for feeling sick and SOB. Patient received her second dose of the covid vaccine on 2/19/21, 3 days prior to presentation. The following day, she started having ""breathing issues"" so she was given a dose of prednisone. 1 day prior to presentation, her breathing had improved but she was feeling generally sick, so she was given tylenol but not pred. Then, today, day of admission, patient was having bodyaches, weakness, headache, and breathing issues again. She took prednisone this morning, but still had to turn up her O2 because her work of breathing kept fluctuating. Admitted 2/22/21 ? 2/24/21.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/19/2021,02/20/2021,1.0,PVT,"Prescriptions: Albuterol MDI and Nebs, aspirin, atorvastatin, Wixela (fluticasone/salmeterol), ipratropium, levothyroxine, lidocaine patch and jelly, mirtazapine, sodium chloride tablets. Over-the -counter: Tylenol, Refresh eye drops, docus",Patient admitted after 1st COVID vaccine for acute on chronic hypoxemic respiratory failure due to exacerbation of severe combined obstructive/restrictive idiopathic ILD possibly due to COVID vaccine reaction 1/31/21 ? 2/2/21.,"COPD on home 2L NC, hypothyroidism, cachexia,",,none,"['Asthenia', 'Condition aggravated', 'Dyspnoea', 'Headache', 'Malaise', 'Pain']",2,PFIZER\BIONTECH,IM 1054160,IL,36.0,M,2/12/2021 woke up with sore arm and back. 2/13/2021 woke up with headache around 1am. Headache and nausea all morning. Mid-late afternoon started having seizures. Admitted to Hospital 2/15/2021 expired. Reported per wife on 2/25/2021.,Yes,02/15/2021,Not Reported,Yes,2.0,Not Reported,N,02/11/2021,02/12/2021,1.0,PUB,unknown,not applicable,Right VP shunt at birth.,,Latex and Ceclor,"['Back pain', 'Death', 'Food allergy', 'Headache', 'Nausea', 'Pain in extremity', 'Seizure']",1,MODERNA,IM 1054171,VA,80.0,M,Resident found unresponsive in his room. CPR performed and patient expired.,Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/21/2021,4.0,SEN,"Pradaxa, Amiodarone, Vitamin C, Atorvastatin, Bumex, Colace, Vitamin B12, ferrous sulfate, Flomax, Flonase, Lyrica, Mag Oxide, Metroprolol Succinate, Potassium, Caridopa-Levadopa, Ultram,","ACUTE ON CHRONIC SYSTOLIC (CONGESTIVE) HEART FAILURE, HYPERTENSIVE CHRONIC KIDNEY DISEASE WITH STAGE 1 THROUGH STAGE 4 CHRONIC KIDNEY DISEASE, OR UNSPECIFIED CHRONIC KIDNEY DISEASE, PARKINSON'S DISEASE, ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS, CHRONIC KIDNEY DISEASE, STAGE 3 UNSPECIFIED","ACUTE ON CHRONIC SYSTOLIC (CONGESTIVE) HEART FAILURE, HYPERTENSIVE CHRONIC KIDNEY DISEASE WITH STAGE 1 THROUGH STAGE 4 CHRONIC KIDNEY DISEASE, OR UNSPECIFIED CHRONIC KIDNEY DISEASE, PARKINSON'S DISEASE, ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS, CHRONIC KIDNEY DISEASE, STAGE 3 UNSPECIFIED,",,Ropinirole,"['Death', 'Resuscitation', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 1054175,VA,71.0,M,"Resident found unresponsive, CPR initiated and EMS called. EMS called time of death after arrival.",Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/23/2021,6.0,SEN,"Plavix, allopurinol, amlodipine, aspirin, Colace, donepezil, finasteride, losartan potassium, oxybutynin, polyethylene glycol, rosuvastatin, vitamin d, Tamsulosin,",Acute Kidney Failure,"Cognitive communication deficit, dysphagia, gout, hyperlipidemia, other abnormalities of gait and mobility, personal history of TI and cerebral infarction without residual deficits, unspecified osteoarthritis, benign prostatic hyperplasia with lower urinary tract symptoms, constipation, essential hypertension, history of falling, obstructive and reflux uropathy, overactive bladder, unspecified dementia without behavioral disturbance.",,No known allergies,"['Death', 'Resuscitation', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 1054185,IA,90.0,M,"Pt awoke the following day with weakness, presented to the emergency room for evaluation. Admitted to hospital on 2-19-21. Required 2L of oxygen by nasal cannula on 2-21-21. Discharged on 2-22-21 to home with home health to cont. and PT and OT.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,02/18/2021,02/19/2021,1.0,PUB,,"history of covid -19 Oct or November 2020, nothing recent in last one month","A-fib, AV block, CAD, PAD, essential HTN, status post aortic valve replacement and cardiac pacer placement",,none but patient stated possibly allergic to penicillin,"['Asthenia', 'Chest X-ray', 'Computerised tomogram head', 'Electrocardiogram', 'Full blood count', 'Metabolic function test', 'Oxygen therapy', 'Troponin', 'Urine analysis']",1,MODERNA,IM 1054192,AZ,71.0,M,Pt's wife reports death 2/23/2021,Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/23/2021,7.0,PUB,Unk,None listed,None listed,,NKA,['Death'],1,MODERNA,IM 1054196,CT,64.0,M,Seizure like activity 2 hours following vaccine,Not Reported,,Not Reported,Yes,,Not Reported,Y,02/24/2021,02/24/2021,0.0,PVT,- Eliquis 5 mg BID - Methadone 60 mg daily - Creon - 2 capsules w/ meals - Amlodipine 10mg daily - Lipitor 40 mg daily - Clonidine 0.1 mg TID - Synthroid 12.5mg daily - Multi Vitamins - Prilosec 20 mg - Pazeo Ophthalmic soln - Seroquel 2,Chronic Pancreatitis,GERD COPD DM PE CVA,,Lisinopril - Angioedema,"['Computerised tomogram head', 'Seizure like phenomena']",1,MODERNA,IM 1054199,NC,75.0,M,"2/5/21 - TIRED AFTERWARDS, THAT NIGHT COULDN'T SLEEP HAVING TROUBLE BREATHING MORE SO THAN NORMAL. NEEDING OXYGEN 24/7 2/6- TIRED, HAVING TROUBLE BREATHING, LOW BLOOD SUGAR, CAN'T SLEEP AT NIGHT - WHEN LAYING DOWN BREATHING IS HARDER, NEEDING OXYGEN 24/7 2/7- EARLY A.M. - EXTREMELY DIZZY FELL AND BROKE TOILET, TIRED, CAN'T SLEEP, WEAK, LOW BLOOD SUGAR, NEEDING OXYGEN 24/7 TROUBLE BREATHING 2/8- SAME SYMPTOMS 2/9- FELL AGAIN - LEGS AND FEET ARE SWOLLEN, NEEDING ASSISTANCE WALKING AND GETTING UP-SAME SMPTOMS AS ABOVE 2/10- SMAE SYPTOMS - TOOK A NAP, BLOOD SUGAR WAS EXTREMELY LOW - GOT BLUE IN THE FACE - METER READ LO - NO NUMBERS, THROAT STARTING TO HURT 2/11 - CAN BARELY GET OUT OF BED SAME SYMPTOMS AS ABOVE 2/12 - SAME SYMPTOMS 2/13 - FINALLY CALLED AMBULANCE - SAME SYMPTOMS AS ABOVE 2/14- ER SAYS HE HAS FLUID IN RIGHT LUNG, POTASSIUM DEPLETED, LEGS STILL SWOLLEN OXYGEN CONTINUES 24/7 EVERYDAY 2/18-DISCHARGED BUT STILL HAVE SAME SYMPTOMS 2/10- SAME SYMPTOMS EVERYDAY - OXYGEN DROPS TO 82- INCOHERENT - GOES BACK TO ER SAME SYMPTOMS TODAY - HAD STAGE 4 KIDNEYS WHEN NORMALLY THEY ARE STAGE 3 - FUNGAL/YEAST INFECTION IN THROAT - DOCTORS DON'T KNOW WHAT IS CAUSING ANY OF THIS ONLY VARIABLE IS THE VACCINE. I WAS JUST THERE ON THE 6TH TO COME BACK HOME, MY DAD WAS INDEPENDENT BESIDES ALL OF HIS HEATLH ISSUES. HE NOW NEEDS A WALKER AND HIS OXYGEN 24/7 - HE NEEDS HELP GOING TO THE BATHROOM AND WASHING HIMSELF. HE IS STILL IN THE ER NOW",Not Reported,,Not Reported,Yes,12.0,Yes,N,02/05/2021,02/05/2021,0.0,MIL,"HE TAKES MEDICINE FOR HIGH BLOOD PRESSURE, COPD, KIDNEYS, HEART DISEASE, DIABETES, DIURETIC, POTASSIUM SUPPLEMENT, INHALER.","HE HAD LOW BLOOD PRESSURE AND LOW BLOOD SUGAR THE DAY OF THE SHOT, DON'T KNOW WHY","STAGE 3 KIDNEYS, COPD, HIGH BLOOD PRESSURE, DIABETES, HEART DISEASE, HAD 3 HEART ATTACKS.",,PENICILLIN,"['Asthenia', 'Blood glucose decreased', 'Blood potassium decreased', 'Chronic kidney disease', 'Condition aggravated', 'Dizziness', 'Dyspnoea', 'Fall', 'Fatigue', 'Fungal infection', 'Gait disturbance', 'Insomnia', 'Mobility decreased', 'Oral fungal infection', 'Oropharyngeal pain', 'Oxygen saturation decreased', 'Oxygen therapy', 'Peripheral swelling', 'Pleural effusion', 'Pulmonary oedema', 'Skin discolouration', 'Sleep disorder', 'Walking aid user']",1,MODERNA,IM 1054201,NY,93.0,F,"Patient developed unsteadiness two days after the vaccine, and became progressively delirious, then obtunded and was placed on comfort care thereafter.",Not Reported,,Yes,Yes,6.0,Not Reported,N,01/31/2021,02/02/2021,2.0,PUB,"Eye drops:Timolol, Lumigan, Isoptocarpine (glaucoma) Trazodone, Lexapro Amilodipine, Lisinopril","Hypertension, UTI (Klebsiella, treated with cipro)","Hypertension, insomnia, glaucoma",,Sulfa drugs,"['Balance disorder', 'Computerised tomogram normal', 'Delirium', 'Depressed level of consciousness', 'Magnetic resonance imaging normal', 'Metabolic function test', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 1054219,FL,,M,"DKA; A spontaneous report was received from a physician concerning a male patient, who experienced diabetic ketoacidosis (DKA). The patient's medical history included pre-diabetes. Product known to have been used by the patient included metformin. On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection. ON 02 Feb 2021, the patient presented to the hospital with DKA. He had no obvious precipitating factors like infection, steroids, cardiac issues per endocrinologist. Patient is due to get his second dose on 15 Feb 2021. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome for the event was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. The patient's medical history of pre-diabetes is a risk factor and confounds causality. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/08/2021,02/02/2021,25.0,UNK,METFORMIN,Pre-diabetes,,,,"['Diabetic ketoacidosis', 'Glycosylated haemoglobin']",1,MODERNA,OT 1054241,,88.0,M,Inpatient hospitalization,Not Reported,,Not Reported,Yes,,Not Reported,,01/22/2021,02/19/2021,28.0,PVT,,,,,,['Hospitalisation'],UNK,PFIZER\BIONTECH, 1054255,VA,41.0,F,"Took the shot on 2/18 and on 2/21 that night about 10:30 my arm started itching below where I got the shot on left arm. Wen to bed and woke up next morning it was broken out with blisters all over body, itching everywhere. I went to see my doctor and she hadn?t seen anything like this. I went to the dermatologist they took 3 biopsy?s and came back with a diagnosis of Sweets Syndrome which is an auto immune disorder, paperwork from dermatologist states that it would be favored more likely due to the vaccine. Now I have no job because I cannot work like this, it breaks out or flares up any my allergies flare up or anything that causes my white blood cells to go up.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/18/2020,02/21/2021,65.0,PVT,"Vit D 50,000 units, Cymbalta, Levocetirizine, Atorvastatin, Omeprazole, Lyrica, Lisinopril , Diclofenac",no,"Fibromyalgia, PTSD, HTN, and high cholesterol",,"Honeydew melon, Neurontin, honey bees","['Acute febrile neutrophilic dermatosis', 'Biopsy', 'Blister', 'Blood test normal', 'Computerised tomogram normal', 'Impaired work ability', 'Injection site pruritus', 'Pruritus']",1,PFIZER\BIONTECH,IM 1054265,,71.0,M,Received first COVID-19 vaccine on 2/18/21. Tested positive for COVID-19 on 2/21/21.,Not Reported,,Not Reported,Yes,,Not Reported,,02/18/2021,02/21/2021,3.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1054266,IL,76.0,M,"caller stated he developed neurological issues a week after receiving the covid vax. Pt became weak, confused, unable walk, hallucinating. He fell 3 times in that week. Symptoms got worse to the point that 911 was called and he was admitted to the Hospital. He had a MRI and CT of brain. MRI on spine. Both had abnormal results w/ no bleeding. Blood Work was normal. He was treated and will be released on Hospice 2/25/2021.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,02/08/2021,02/15/2021,7.0,OTH,"lantus insulin daily, metoprolol, torsemide, spironolactone, carbidopa/levodopa, fludrocortisone, Vitamin D,",no,"Parkinson's, Diabetes, Heart Valve Disease, Anemia,",,no,"['Asthenia', 'Blood test', 'Computerised tomogram head', 'Computerised tomogram head abnormal', 'Confusional state', 'Fall', 'Gait inability', 'Hallucination', 'Magnetic resonance imaging brain abnormal', 'Magnetic resonance imaging spinal abnormal', 'Neurological symptom']",1,MODERNA,IM 1054285,CT,50.0,F,"The day after the vaccine she experienced malaise, fever and chills. That resolved. Four days later she developed angio-edema that developed over the course of 6 hours with shortness of breath and weakness and confusion. She had laryngeal edema. she was treated with epinephrine, steroids and antibiotics. symptoms improved within 24 hours and resovled by 48 hours to 72 hours. she was discharged after 3 days in the hospital",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/11/2021,02/15/2021,4.0,PVT,"dasatinib, 100 mg, Oral, Nightly escitalopram, 20 mg, Oral, Nightly loratadine, 10 mg, Oral, Daily LORazepam, 1 mg, Oral, Nightly Lisinopril 10 mg oral daily",Multiple sclerosis Chronic Myelocytic leukemia Hypertension GERD,"Prior history of angio-edema of unknown causes, 5 years previous",,"cephalosporins, anaphalaxis","['Angioedema', 'Asthenia', 'Chest X-ray normal', 'Chills', 'Computerised tomogram neck', 'Condition aggravated', 'Confusional state', 'Dyspnoea', 'Full blood count normal', 'Laboratory test normal', 'Laryngeal oedema', 'Malaise', 'Pyrexia']",UNK,MODERNA, 1054337,DE,90.0,M,FOUND DEAD IN HIS OWN BED,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,MIL,several including METOPROLOL ER SUCCINATE 50 MG TABS,NONE,HEART CONDITION,,UNKNOWN,['Death'],UNK,MODERNA,SYR 1054339,NC,57.0,F,2/22/21- Husband reported redness to injection site. Took to ER 2/23/21- Husband reported patient was admitted as inpatient for cellulitis and will be kept in hospital for IV antibiotics until 2/25/21 or 2/26/2021,Not Reported,,Not Reported,Yes,,Not Reported,U,02/17/2021,02/21/2021,4.0,PUB,Not known,Not known,Not known,,Not known,"['Cellulitis', 'Injection site erythema']",2,MODERNA,IM 1054353,CT,60.0,F,"10 daya after receiving Moderna vaccine: 60 year old right handed woman with migraine + chronic headaches, nephrolithiasis, who presented to the hospital with expressive aphasia and right facial weakness and was found to have at least to distal left MCA occlusions for which she received IV tPA. �MRI brain shows a small left frontal cortical acute ischemic stroke. �Post tPA ICU course has been notable for angioedema of the tongue now improved. TTE showed PFO. LDL 111, new diagnosis HLD. �",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/06/2021,01/16/2021,10.0,PVT,Culturelle 1 capsule qd Magnesium 30 mg po QD/prn,None,None,,"Vyvanse [Lisdexamfetamine] Chest Pain High 12/21/2020 Past Updates... Pt states she had chest tightness Alteplase Angioedema Not Specified 1/17/2021 Past Updates... OF NOTE: pt has stated that if she were to need tPA in the future because of stroke that she believes benefit outweighs risk and would still like it administered if needed along with benadryl and solumedrol Cats Not Specified 7/6/2017 Past Updates... Dogs Not Specified 7/6/2017 Past Updates... Environmental Allergies Not Specified 1/23/2016 Past Updates... Grass Pollen Not Specified 7/6/2017 Past Updates... Not the drug Ibuprofen Not Specified 3/28/2008 Past Updates... --BLURRED VISION ; Nitrate Analogues Headache Not Specified 5/19/2017 Past Updates... Sulfites Headache Not Specified 5/19/2017 Past Updates... Tree And Shrub Pollen Not Specified 7/6/2017 Past Updates... Not the drug Yeast, Dried Not Specified 8/28/2014 Past Updates... Pt get headaches","['Angioedema', 'Anti factor VIII antibody increased', 'Antiphospholipid antibodies', 'Aphasia', 'Atrial septal defect', 'Cerebral artery occlusion', 'Echocardiogram', 'Facial paresis', 'Hyperlipidaemia', 'Intensive care', 'Ischaemic stroke', 'Low density lipoprotein increased', 'Magnetic resonance imaging brain abnormal', 'Sleep study', 'Venogram normal', ""Von Willebrand's factor antigen increased""]",1,MODERNA,IM 1054424,WI,83.0,F,"Patient resides in an assisted living facility and received the second COVID-19 vaccination. She experienced fatigue in the morning following vaccination. She fell on 2/22/21. Ambulance was called and she was transported to the hospital. Initial symptoms included fever of 101 F, disorientation, left face droop, unresponsive to commands and loss of memory.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/18/2021,02/19/2021,1.0,PHM,"levothyroxine, clopidogrel, senna, aspirin",None,"Heart disease, hypothyroidism, stroke, osteoporosis",,NKA,"['Amnesia', 'Chest X-ray', 'Computerised tomogram head', 'Conversion disorder', 'Disorientation', 'Electroencephalogram normal', 'Facial paralysis', 'Fall', 'Fatigue', 'Full blood count', 'Magnetic resonance imaging normal', 'Nervous system disorder', 'Pyrexia', 'Ultrasound scan normal', 'Unresponsive to stimuli', 'X-ray limb']",2,PFIZER\BIONTECH,IM 1054432,OH,79.0,F,"Patient was given the vaccine and waited the recommended time (15 minutes) after the administration of the vaccine and did not report any reaction at that time. Approximately six hours after the injection, she suddenly noticed she was having trouble breathing, could not catch her breath, and a call was made to 911. She was transported via ambulance to the hospital, where she remained for a week.",Not Reported,,Not Reported,Yes,7.0,Not Reported,U,01/14/2021,01/14/2021,0.0,SEN,"Riluzole (50mg), Melatonin (5mg), Eliquis (5mg), Lansoprazole (30mg), Nutren (feeding tube), Albuterol (3mg), Carvedilol (3.125mg), and Acetaminophen (325mg).",ALS,Asthma,,None,"['Asthenia', 'Asthma', 'Asthma exercise induced', 'Blood test', 'Chest X-ray', 'Chest pain', 'Dyspnoea', 'Echocardiogram', 'Electrocardiogram', 'Oedema', 'Urinary tract infection', 'Urine analysis abnormal', 'Wheezing']",1,PFIZER\BIONTECH,SYR 1054434,KY,83.0,M,"Patient reported to emergency room on 2/20 with increasing of shortness of breath, quantitated unable to walk from room to room in his house. Patient was admitted.",Yes,02/24/2021,Not Reported,Yes,4.0,Not Reported,N,01/29/2021,02/24/2021,26.0,PVT,,,,,,"['Dyspnoea', 'Gait inability']",1,PFIZER\BIONTECH,IM 1054435,AL,89.0,M,Patient passed on 01/28/2021 per family member.,Yes,01/28/2021,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/28/2021,1.0,PUB,Low dose oral Chemo,Patient has CLL,,,,['Death'],1,MODERNA,IM 1054524,MN,85.0,M,"Headache, worsening of his neurologic status, dizziness, change in gait, shuffling feet, then unable to walk, more sleepy, unable to move extremities, unable to speak, tremors",Not Reported,,Yes,Yes,4.0,Not Reported,Y,02/16/2021,02/21/2021,5.0,OTH,"allopurinol, ASA, finasteride, losartan, Benicar, multivitamin",none,"HTN, gout, Chronic Hep B, ILD, cataract",,NKA,"['Aphasia', 'Blood culture negative', 'CSF cell count normal', 'Chest X-ray normal', 'Computerised tomogram head normal', 'Dizziness', 'Gait disturbance', 'Gait inability', 'Headache', 'Lumbar puncture normal', 'Movement disorder', 'Neurological decompensation', 'Paralysis', 'Protein total increased', 'Somnolence', 'Tremor']",2,PFIZER\BIONTECH,IM 1054532,NJ,37.0,F,"BP measured 168/95. Currently experiencing malignant hypertension with blood pressures averaging 180/110; feel flushed; 10 weeks post partum; 10 weeks post partum; This is a spontaneous report from a contactable other healthcare professional (patient). This reporter reported information for both mother and fetus. This is the maternal report. A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) at arm left via an unspecified route of administration on 08Feb2021 16:45 at single dose for covid-19 immunisation. Medical history included 10 weeks post partum vaginal delivery without complications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included colecalciferol (VITAMIN D), enzymes nos, fungi nos, herbal nos, minerals nos, nutrients nos, probiotics nos, proteins nos, vitamins nos (ATHLETIC GREENS), and prenatal vitamin. The patient, 10 weeks post partum without any PHMx of hypertension (HTN), received vaccine and immediately started to feel flushed, was laid supine and Blood pressure (BP) measured 168/95. Currently experiencing malignant hypertension with blood pressures averaging 180/110, unable to be controlled w amlodipine prescribed by MD. Event onset date was 10Feb2021 12:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events malignant hypertension and feel flushed was not recovered.; Sender's Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate ,Linked Report(s) : US-PFIZER INC-2021167922 mother/child cases",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/08/2021,0.0,PVT,VITAMIN D; ATHLETIC GREENS,,Medical History/Concurrent Conditions: Vaginal delivery (10 weeks post partum vaginal delivery without complications),,,"['Blood pressure measurement', 'Flushing', 'Malignant hypertension', 'Off label use', 'Product use issue']",1,PFIZER\BIONTECH, 1054548,IN,77.0,F,"On February 15 when I got up I had rapid, pounding heartbeat, felt exhausted, and had panic attacks",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/13/2021,02/15/2021,2.0,PVT,"Levothyroxine 75 mcg, colchicine .6 mg, hydroxychloroquine 200 mg",,Thyroid and arthritis,,Sulfa Antibiotics,"['Fatigue', 'Heart rate increased', 'Palpitations', 'Panic attack']",1,MODERNA,SYR 1054551,KY,70.0,M,Resident expired on 2/29/21.,Yes,02/19/2021,Not Reported,Not Reported,,Not Reported,N,01/16/2021,02/18/2021,33.0,SEN,,"N/A, under hospice care for end of life",Major Neurocog Disability,,NKA,['Death'],2,PFIZER\BIONTECH,IM 1054573,AZ,74.0,F,"Acute onset difficulty breathing with stridor/difficulty breathing. Tx as allergic rxn/anaphylaxis. Interventions from patient included albuterol breathing treatment. EMS provided Solu-Medrol, DuoNeb breathing treatment. Continued significant stridor on presentation to emergency department. Emergency department provided IM epinephrine, IV Benadryl, IV famotidine, racemic epinephrine breathing treatment. Symptoms improved. Stridor resolved.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/25/2021,02/25/2021,0.0,PVT,Adderall Albuterol Patient otherwise initially unclear,none,Asthma Psoriasis,,statin drugs,"['Anaphylactic reaction', 'Chest X-ray', 'Dyspnoea', 'Electrocardiogram ST segment depression', 'Stridor']",UNK,PFIZER\BIONTECH, 1054586,WI,81.0,M,"The patient developed sudden onset nausea, diaphoresis and hypotension and shaking. Symptoms improved with IV fluids and rest. She was hospitalized 2 days.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/03/2021,02/22/2021,19.0,UNK,"docusate sodium, multivitamin, paroxetine, risperidone, trazodone, albuterol, ketoconazole shampoo, psyllium wafer","1. Diastolic dysfunction 2. Anxiety with depression 3. Obstructive sleep apnea 4. Major neurocognitive disorder and mood disorder with psychotic features. 5. Frontotemporal dementia, following with neurology and underwent neuro-psych evaluation in fall 2020.","1. Diastolic dysfunction 2. Anxiety with depression 3. Obstructive sleep apnea 4. Major neurocognitive disorder and mood disorder with psychotic features. 5. Frontotemporal dementia, following with neurology and underwent neuro-psych evaluation in fall 2020.",,"doxycycline, ibuprofen, levaquin, morphine, penicillin, cephalexin, tolmetin","['Fibrin D dimer increased', 'Hyperhidrosis', 'Hypotension', 'Nausea', 'Tremor']",1,PFIZER\BIONTECH,SYR 1054591,IN,47.0,M,"Stroke on January 20th, 2021. Unknown cause for blood clot.",Not Reported,,Not Reported,Yes,2.0,Yes,N,01/08/2021,01/20/2021,12.0,PVT,None,none,none,,no,"['Angiogram', 'Blindness', 'Cerebrovascular accident', 'Computerised tomogram abnormal', 'Echocardiogram', 'Ophthalmological examination abnormal', 'Scan with contrast', 'Thrombosis', 'Ultrasound Doppler', 'Visual field tests abnormal']",2,PFIZER\BIONTECH,IM 1054592,KY,68.0,M,"Resident expired on 2/24/21, under hospice care.",Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,01/16/2021,02/24/2021,39.0,SEN,"Tylenol, ASA, Cogentin, Bisacodyl, Cetrizine, B12, Depakote, Ativan, Metformin, Multivitamin, Risperdal, Senna tabs.",,1. Mood disorder with behavioral disturbance #2 psychotic disorder #3 atypical anxiety #4 dementia with behavioral disturbance #5 cognitive communication deficit #6 impulse control disorder #7 chronic constipation #8 generalized chronic pain #9 hypomagnesia anemia #10 seborrheic dermatitis #11 B12 deficiency #12 type 2 diabetes mellitus #13 hypertension #14 anemia #15 degenerative joint disease #16 seizure disorder #17 GERD #18 hyperlipidemia #19 history of peptic ulcer disease #20 diverticulosis of the colon #21 thrombocytopenia unspecified,,NKA,"['Death', 'Sepsis']",2,PFIZER\BIONTECH,IM 1054601,MD,25.0,F,"2/15 approx. 8PM: shoulder pain began 2/15 approx. 9PM: continued pain with arm heaviness/weakness, extremely limited range of motion 2/15 approx. 9PM: unable to perform ADL since; Tylenol 1000 mg q6h until 2/20 with little relief 2/18: resumed to work (remote computer work) 2/22: slight improvement in shoulder pain and range of motion, yet limited; could lay/put pressure on left side for the first time since 2/15 2/24: used arm for first time aside from ADLs as I had less pain and slightly improved ROM; worked COVID-19 vaccine clinic and lifted left arm to prepare doses for patients 2/24 5PM: took ibuprofen 400 mg with little relief 2/25: burning sensation/pain deep within left shoulder, range of motion more limited than on 2/24; took ibuprofen 400 mg with little relief; difficulty performing ADLs and typing on computer for remote work duties",Not Reported,,Not Reported,Not Reported,,Yes,N,02/15/2021,02/15/2021,0.0,OTH,Dicyclomine 10 mg tablet Drospirenone and Ethinyl Estradiol 3 mg/0.03 mg tablet,None,"Controlled IBS, asthma, iron-deficiency anemia",,"Dayquil: tongue/throat swelling, SOB","['Arthralgia', 'Burning sensation', 'Joint range of motion decreased', 'Limb discomfort', 'Loss of personal independence in daily activities', 'Muscular weakness']",2,MODERNA,IM 1054637,VA,79.0,M,Patient received Covid vaccine 1st dose: unknown mfg a few days after kyphoplasty s/p vertebral compression fracture then reported new onset delusions. Patient has baseline brain damage and used midazolam for sedation for kyphoplasty 02/12. Patient has been admitted on 02/22 AMS and has since been improving. Neither Dr. or Pharm D. have further information about covid vaccine specifications. Patient's household would need to be contacted,Not Reported,,Not Reported,Yes,7.0,Not Reported,N,02/01/2021,02/21/2021,20.0,PVT,"Eliquis, lopressor, anoro ellipta, zocor",vertebral compression fracture 02/09/21,"CAD; Afib, Hx of lung CA, HTN, PVD, coronary stents, BPH, fractures",,nkda,"['Brain injury', 'Delusion', 'Vertebroplasty']",1,MODERNA,IM 1054648,CA,81.0,M,"Severe hives accompanied by shivering, significant itching, three fainting episodes close together about 8 hours after the onset of the hives and very low blood pressure following the fainting episode. At home treatment taken on phone advise from Doctorr with Benadryl and Fomantadine with no effect. Prednisone now prescribed. Doctor had suggested a visit to ER but this was taken as the patient was more stable at this time. Potential life threatening event due to the fainiting and low blood pressure/heart rate. These symptoms have occured on previous occassions as a result of virus and other infections.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/22/2021,02/23/2021,1.0,PUB,,None,None,,Penicillin,"['Chills', 'Heart rate decreased', 'Hypotension', 'Pruritus', 'Syncope', 'Urticaria']",2,MODERNA,IM 1054694,NM,83.0,M,"Pt received vaccine on 1/29/2021 and died on 2/13/2021. Wife called agency and noted the pt received his 1st dose of vaccine and was having ""side effects and began declining"". It is unknown what side effects he was having.",Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/13/2021,15.0,PVT,,,"HTN, BPH, OSA, Obesity",,none,"['Death', 'General physical health deterioration']",1,PFIZER\BIONTECH,IM 1054698,KY,89.0,F,"THE RESIDENT WAS ROUTINELY TESTED FOR COVID ON 1/29/21 AND POSITIVE RESULTS RETURNED ON 1/30/21; WAS ASYMPTOMATIC AT FIRST, BUT DEVELOPED SYMPTOMS ON 1/31/21 THAT PROGRESSED AND THE RESIDENT DIED ON 2/7/21",Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/30/2021,12.0,SEN,"SEROQUEL, METOPROLOL, TRAMADOL, LASIX",,"PVD, A. FIB, HYPERLIPIEMIA, HYPOTHYROIDISM, DEPRESSION",,"PENICILLIN, PRADAXA, REMERON, VESICARE","['COVID-19', 'Death', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1054699,WI,82.0,M,Patient was found at 6 AM on 01/21/2021 - he passed away during his sleep,Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/21/2021,1.0,SEN,"Atorvastatin, tamsulosin, M vit. clopidogrel; aspirin; sertraline, melatonin, losartan, myrbetriq, senna, vit. D",,"PRimaRy hypertension, HypeRlipidemia, BRadycaRdia",,Penicillin,['Death'],1,MODERNA, 1054790,PA,70.0,F,"Rash that was very itchy/arm look different; Hives/ rash from the jaw to the neck; Painful circle of rash at the site of the injection; Painful circle of rash at the site of the injection; When they received the vaccine they noticed some liquid dripped; A spontaneous report was received from a consumer concerning 70 year old female patient. The patient's medical history was not provided. Concomitant medication included unspecified blood pressure medication, unspecified cholesterol medication, unspecified thyroid medication, Women's One A Day, Aspirin, Colace, Vitamin C, Vitamin D, two unspecified nasal sprays, and allopurinol. On 29Jan2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 011L01A) in the left arm for prophylaxis of COVID-19 infection. On 29Jan2021, the patient noticed some liquid dripped during the vaccination, and experienced a very painful circle of rash at the injection site. On an unspecified day, 7th day after the vaccination, the patient experienced her arm looking very different with a bigger rash that was very itchy. On an unspecified date, the next day, the patient experienced a rash that reached her neck and it turned into something like hives and was very itchy. The patient was treated with Keflex, clindamycin, and hydroxyzine. Action taken with the mRNA-1273 was not reported. The outcome of the events of incorrect dose administered, vaccination site rash, vaccination site pain, rash pruritic, and urticaria was unknown.; Reporter's Comments: This report refers to a case of vaccine underdose, administered for mRNA-1273, lot # 011L01A with associated adverse events of vaccination site rash, vaccination site pain, rash pruritic, and urticaria. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,UNK,ONE A DAY WOMEN'S; ASPIRIN (E.C.); COLACE; VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]; VITAMIN D NOS; ALLOPURINOL,,Medical History/Concurrent Conditions: No adverse event (Medical history not reported),,,"['Rash pruritic', 'Underdose', 'Urticaria', 'Vaccination site pain', 'Vaccination site rash']",1,MODERNA,OT 1054791,,80.0,F,"Faint; Hives up and down both of her arms; Felt warm; A spontaneous report was received from a healthcare professional, concerning a 80-year-old, female patient who was administered Moderna's COVID-19 vaccine and felt warm, faint and hives occurred afterwards up and down both of her arms. The patient's medical history was not provided. No relevant concomitant medications were reported. On 19-Jan-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 042670A) intramuscularly, for prophylaxis of COVID-19 infection. On 19-Jan-2021, right after getting her vaccine patient felt warm and faint afterwards. Approximately, eight or nine days after the injection, patient had hives up and down both of her arms. Patient was concerned if it was a systemic allergic reaction and likeliness of another reaction in future with increased severity. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, felt warm, faint and hives occurred afterwards up and down both of her arms were considered unknown.; Reporter's Comments: This report concerns a 80--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # 042670A , and felt warm, faint and hives occurred afterwards up and down both of her arms. Very limited information regarding this event has been provided at this time. Further information has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,01/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Feeling hot', 'Syncope', 'Urticaria']",1,MODERNA,OT 1054792,OH,,F,"down to wrist was really hot; swelled, but just a little puffy; administered too high on shoulder; hurting and pain across back; pain on back of shoulder, deep, felt like a toothache; A spontaneous report was received from a consumer concerning a 65 Years-old female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced administered too high on shoulder(Product administered at inappropriate site), hurting and pain across back(Back pain), pain on back of shoulder, deep, felt like a toothache(Arthralgia), down to wrist was really hot(Feeling hot), deep pounding sensation in the middle of back(Musculoskeletal discomfort), swelled, but just a little puffy(Injection site swelling), nervous wreck(Nervousness). The patient's medical history was not provided. concomitant medication includes Advil. 02-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032620A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. 02-Feb-2021, The patient feels vaccine may have been administered too high on shoulder(Product administered at inappropriate site) and also experienced events of hurting and pain across back(Back pain), pain on back of shoulder, deep, felt like a toothache(Arthralgia), down to wrist was really hot(Feeling hot), deep pounding sensation in the middle of back(Musculoskeletal discomfort), swelled, but just a little puffy(Injection site swelling), nervous wreck(Nervousness). No Laboratory details provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events down to wrist was really hot(Feeling hot), swelled, but just a little puffy(Injection site swelling) is resolved and the outcome for hurting and pain across back(Back pain), pain on back of shoulder, deep, felt like a toothache(Arthralgia), deep pounding sensation in the middle of back(Musculoskeletal discomfort), nervous wreck(Nervousness) is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of back pain, arthralgia, feeling hot and vaccination site swelling, a causal relationship cannot be excluded. The event of product administered at inappropriate site is assessed to be not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: no adverse event, Continue: [UNK], Comment: No reported medical history",,,"['Arthralgia', 'Back pain', 'Feeling hot', 'Product administered at inappropriate site', 'Vaccination site swelling']",1,MODERNA,OT 1054793,FL,,M,"Arm very red; Arm bruised; arm was very sore; Injected in an improper location; he felt pain with the needle and pain while the liquid of the vaccine was entering to the arm; Arm immediately started to swell up; A spontaneous report was received from a consumer concerning a male patient, of unknown age, who experienced feeling pain with the needle, pain while the liquid of the vaccine was entering to the arm and arm very sore/MedDRA PT: vaccination site pain, arm immediately started to swell up/ MedDRA PT: vaccination site swelling, arm very red/ MedDRA PT: vaccination site erythema, arm bruised/ MedDRA PT: vaccination site bruising, and injected in an improper location/ MedDRA PT: product administered at inappropriate site. The patient's medical history included recurrent kidney stones, allergy to penicillin, and drug allergy to rovastatin. No relevant concomitant medications were reported. The patient received his first of two planned doses of mRNA-1273 (Lot 011L20A) on 08 Jan 2021 intramuscularly in the left upper arm. On 05 Feb 2021, prior to the onset of the events, the patient received his second of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly in the left upper arm for prophylaxis of Covid-19 infection. The patient stated that when he received the first vaccine on 08 Jan 2021, it was a wonderful experience, and he did not feel the injection and did not experience any side effect. But, when he received the second dose on 05 Feb 2021, the injection itself was not well administered. Injector was distracted or not fully trained, and the patient felt pain with the needle and pain while the liquid of the vaccine was entering to the arm. After that, injector put a bandage but caller states that it was not placed where he receives the vaccine. While he was leaving the facility, the arm immediately started to swell up. The patient stated that he thought the swelling was due to accumulation of the vaccine in the place where the vaccine was really administered, a few inches away from the site the first vaccine was administered. The day after the arm was very sore, red and bruised, but he thought it is because the administration of the needle, not a side effect of the vaccine. Both vaccines where administered in the upper left arm, but caller does not known if the second was in target. Unfortunately, had an incompetent injector who gave him a painful experience with the injection and the realize of the vaccine. Wanted to find out if should be concern that may have injected in an improper location and weather if gave him in other location, if should be concern that he may have not full effect of the vaccine. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome for the events of feeling pain with the needle, pain while the liquid of the vaccine was entering to the arm and arm very sore, arm immediately started to swell up, arm very red, arm bruised, was unknown. The event, injected in an improper location, was considered recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event a casual relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,Drug allergy (Drug allergy to Rovastatin (possibly).); Kidney stones (Recurrent); Penicillin allergy,,,,"['Pain in extremity', 'Product administered at inappropriate site', 'Vaccination site bruising', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",2,MODERNA,OT 1054794,TX,62.0,F,"2nd dose was scheduled for 25Jan2021, but she has not received yet; COVID-19 virus test positive; A spontaneous report was received from a consumer concerning a 62-year-old, female patient who was administered Moderna's COVID-19 vaccine and tested positive for COVID and her 2nd dose was scheduled but she has not received yet. The patient's medical history included high blood pressure and high cholesterol. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (Lot number:025L20A) unknown route of administration on 30 Dec 2020. Patient received the first dose on 30 Dec 2020. Patient tested positive for COVID on 20 Jan 2021. Her second dose was scheduled for 25 Jan 2021, but she has no received yet. Patient wanted to know if she should receive the 2nd Moderna vaccine. No treatment information was provided. Consent to follow up was given. The second dose of mRNA-1273 was discontinued in response to the event. The event, her 2nd dose was scheduled but she has not received yet were considered resolved. The outcome for the event tested positive for COVID considered unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/20/2021,21.0,UNK,,High cholesterol (No reported medical history.); Hypertension (No Reported medical history.),,,,"['Product dose omission issue', 'SARS-CoV-2 test positive']",1,MODERNA,OT 1054795,HI,,F,"Given 1 ml of vaccine instead of 0.5ml; A spontaneous report was received from a pharmacist concerning a female patient, received Moderna's COVID-19 Vaccine and was given Moderna's vaccine 1ml instead of 0.5ml. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 016M20A) on 09 Feb 2021, intramuscularly in left arm for the prophylaxis of COVID-19 infection. On 09 Feb 2021, the patient received 1ml of the vaccine instead of 0.5ml. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, given Moderna's vaccine 1ml instead of 0.5ml, was considered resolved on 09 Feb 2021.; Reporter's Comments: This reports refers to a case of Accidental overdose for mRNA-1273 (Batch number: 016M20A) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Accidental overdose'],1,MODERNA,OT 1054796,WI,67.0,F,"given a lesser dose; A spontaneous report was received from a consumer concerning a 67-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an accidental underdose. The patient's medical history was not provided. Concomitant medications were not provided. On 12 FEB 2021, the patient received her first dose of mRNA-1273 (lot number 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient was called thirty minutes after receiving her first dose of the vaccine by the pharmacist to have her come back to the facility. The pharmacist explained that there was a medication error and they wanted to make sure that the patient got the full dose. Treatment for this event was not reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, accidental underdose was considered recovered.; Reporter's Comments: This case concerns a 67-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting accidental underdose without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Accidental underdose'],1,MODERNA,OT 1054797,NV,25.0,F,"Rapid heartbeat; Shortness of breath; Pain at injection site; Chills; Fatigue; Fever; A spontaneous report was received from a consumer concerning a 25 years-old, female patient who experienced rapid heartbeat/MedDRA PT: tachycardia, shortness of breath/MedDRA PT: dyspnoea, pain at injection site/MedDRA PT: vaccination site pain, chills/MedDRA PT: chills, fatigue/MedDRA PT: fatigue, and fever/MedDRA PT: pyrexia. The patient's medical history included anemia and low immune system. Concomitant product use was not provided by the reporter. On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 025A202A) intramuscularly (injection site not provided) for prophylaxis of COVID-19 infection. On 23 Jan 2021, after receiving vaccination, the patient experienced pain at injection site, chills, fever, fatigue and shortness of breath. On 24 Jan 2021, the patient experienced rapid heartbeat. The patient was hospitalized and during hospitalization, heart rate was noted as 125 bpm which reduced down to 110 bpm. The patient was discharged on 25 Jan 2021. Following hospitalization, patient had ongoing fever and was advised to contact hospital for direction regarding readmission. Treatment included self-administered Tylenol, six times daily. Action taken with mRNA-1273 in response to the events was unknown. The events chills and shortness of breath were considered resolved on 24 Jan 2021. The events pain at injection site, fatigue, and rapid heartbeat were considered resolved on an unknown date. The event fever was considered not resolved.; Reporter's Comments: This case concerns a 25-year-old female who experienced serious expected events of tachycardia and dyspnea along with nonserious expected events of fever, chills, fatigue and vaccination site pain. The events occurred 1 day after the first dose of mRNA-1273. Treatment included Tylenol. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/23/2021,01/23/2021,0.0,UNK,,Anemia; Immune system disorder NOS,,,,"['Chills', 'Dyspnoea', 'Fatigue', 'Heart rate', 'Pyrexia', 'Tachycardia', 'Vaccination site pain']",1,MODERNA,OT 1054798,WI,70.0,M,"Was given a lesser dose; A spontaneous report was received from a healthcare professional and a consumer concerning 70 year old male patient. The patient's medical history was not provided. No relevant concomitant medication was reported. On 12Feb2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12Feb2021, the vaccine provider (pharmacist) performed an accidental underdose. The pharmacist informed the patient to go back and receive the full recommended dose. No treatment was reported. Action taken with the mRNA-1273 was not reported. The event, accidental underdose, was considered resolved.; Reporter's Comments: This report refers to a case of Product administration error of accidental underdose for mRNA-1273(lot number 031M20A), with no associated AEs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical history not reported),,,['Accidental underdose'],1,MODERNA,OT 1054799,MS,,F,"injection site bled; arms is swollen; Arm is painful; Arm is red; Arm is tender; not injected properly into muscle; A spontaneous report was received from a healthcare professional who was also a 63 year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and the vaccine was not injected properly into muscle / incorrect route of product administration, and experienced injection site bleeding / vaccination site haemorrhage, arm was swollen / peripheral swelling, arm was painful / painful extremity, arm was red / erythema, and arm was tender / tenderness. The patient's medical history was not provided. Concomitant medication included metformin, tamoxifen, Synthroid, spironolactone, Protonic, vitamin D, and magnesium. On an unspecified date, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection. On an 12Feb2021, the patient received the second of the planned doses of mRNA-1273 (lot number 041L20A) for prophylaxis of COVID-19 infection. On 12Feb2021, the patient experienced injection site bleeding, arm swollen, painful, hot, and tender. No treatment was reported. Action taken with the mRNA-1273 was not reported. The outcome of the event, not injected properly into muscle, was resolved on 12 Feb 2021. The outcome of the events, injection site bleeding, arm was swollen, arm was painful, arm was red, and arm was tender, was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,UNK,METFORMIN; TAMOXIFEN; SYNTHROID; SPIRONOLACTONE; PROTONIX [OMEPRAZOLE]; VIT D3; MAGNESIUM,,Medical History/Concurrent Conditions: No adverse event (Medical history not reported),,,"['Erythema', 'Incorrect route of product administration', 'Pain in extremity', 'Peripheral swelling', 'Tenderness', 'Vaccination site haemorrhage']",1,MODERNA,OT 1054800,,,U,"Received a vaccine outside the six hour window; A spontaneous report was received from a consumer concerning a patient (demographics not provided) who received a vaccine outside the six hour window. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, the patient received dose of mRNA-1273 (Lot # unknown) (dose number, route of administration and injection site not provided) for prophylaxis of COVID-19 infection. On unknown date, the patient received mRNA-1273 vaccine outside the six hour window. Action taken with mRNA-1273 in response to the event was not provided. The event, received a vaccine outside the six hour window was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of patient of unknown age and gender who experienced Expired product administered for mRNA-1273 (lot # unknown) with no associated adverse events. The patient received mRNA-1273 vaccine outside the six hour window. Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Expired product administered'],1,MODERNA,OT 1054813,,82.0,M,Chest clear - Hospitalized for a UTI,Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,,01/08/2021,01/29/2021,21.0,UNK,,,,,,['Urinary tract infection'],UNK,MODERNA, 1054819,,71.0,F,Pt noticed elevated blood pressure readings at home up to 190s systolic 3 days after vaccination. Also reporting left shoulder and neck pain which also began 3 days after vaccination.,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/21/2021,02/24/2021,3.0,PVT,"amlodipine, aspirin, buspirone, clonidine patches, enalapril, famotidine, Flonase, insulin detemir, Januvia, metformin",,"coronary artery disease, diabetes, hyperlipidemia, hypertension, anxiety, GERD",,iodinated diagnostic agents,"['Arteriovenous fistula', 'Arthralgia', 'Blood pressure increased', 'Electrocardiogram T wave abnormal', 'Electrocardiogram T wave inversion', 'Hypertension', 'Neck pain']",1,MODERNA,IM 1054820,MO,64.0,F,"PT BECAME UNRESPONSIVE AFTER VACCINE GIVEN, EPIPEN ADMINISTERED, 911 CALLED, PT HOSPITALIZED",Not Reported,,Not Reported,Yes,,Not Reported,U,02/22/2021,02/22/2021,0.0,SEN,PT WAS GIVEN SECOND DOSE OF MODERNA COVID 19 AND PASSED OUT/UNRESPONSIVE AFTER VACCINATION. EPIPEN WAS ADMINISTERED AND EMS CALLED. PT WAS HOSPITALIZED. FIRST DOSE OF MODERA COVID 19 VACCINE GIVEN 1/25/21 WITH NO REACTION.,,ASTHMA,,NONE LISTED,['Unresponsive to stimuli'],2,MODERNA,IM 1054826,MI,36.0,F,"Premature infant born at hospital after premature labor was found to have injured brain tissue (PVL) on cranial ultrasound after delivery. Timing of the injury coincides with maternal clinical illness after second Covid vaccine, about two weeks prior to delivery. The mother and father asked me whether the Covid vaccine could have contributed to the brain injury. I reassured them that the Covid vaccine is felt to be safe during pregnancy, but that I would report the concern.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/1921,02/22/2021,36553.0,PVT,"Pre natal vit, Zofran, pepcid","Depression, bipolar, anxiety, panic attacks, migraines, asthma, gestational diabetes","Depression, bipolar, anxiety, panic attacks, migraines, asthma",,NKA,"['Brain injury', 'Foetal exposure during pregnancy', 'Premature baby', 'Premature delivery', 'Premature labour', 'Ultrasound skull']",2,PFIZER\BIONTECH,IM 1054835,,70.0,F,"Patient received 2nd COVID vaccine on 2.13.2021. Patient's family says the patient experienced fatigue, shortness of breath, dizziness, and muscle pain after the second injection. Family says the patient was taken to the ER and airlifted on a ventilator to hospital. Family says she has not tested positive for COVID and that she does not have a diagnosis at this time. As of today, 2.25.21, the patient is out of the ICU, but still hospitalized.",Not Reported,,Not Reported,Yes,10.0,Not Reported,N,02/13/2021,02/16/2021,3.0,PVT,Available if needed,COPD exacerbation x 2,GERD COPD Asthma Type II DM HTN Hyperlipidemia Hypokalemia,,Amoxicillin - rash Z-pak - diarrhea NSAIDs - GI hemorrhage PCN - rash Bactrim - rash Suprax - rash,"['Dizziness', 'Dyspnoea', 'Fatigue', 'Intensive care', 'Mechanical ventilation', 'Myalgia', 'SARS-CoV-2 test negative']",2,MODERNA,IM 1054857,,76.0,F,"Same day pt developed burning pain with urination and fever of 101F the same day. Pt came to the hospital, was not determined to have a urinary tract infections. No fevers during time in the hospital.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/23/2021,02/23/2021,0.0,PVT,"Tylenol, Coenzyme Q10, Pradaxa, Lexapro, estradiol patches, women's multivitamin, riboflavin",,"paroxysmal atrial fibrillation, anxiety",,Percodan,"['Dysuria', 'Pain', 'Pyrexia', 'Urinary tract infection', 'Urine analysis normal']",2,PFIZER\BIONTECH,IM 1054859,IN,102.0,M,No details - patient died on 1/22/2021,Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/22/2021,7.0,PUB,not reported,,"COPD, chronic kidney disease, heart disease",,not reported,['Death'],UNK,MODERNA,IM 1054867,CA,67.0,F,I hade a seizure after second shot,Not Reported,,Not Reported,Yes,6.0,Not Reported,U,02/17/2021,02/18/2021,1.0,OTH,"Lexapro, simivistatin, zetia, lipoid c, calcium, baby aspirin, Zinc, psyllium husk",Sub clinical atherosclerotic heart disease Anxiety and depression Migraine Anemia,See above,,Macrobid,['Seizure'],2,MODERNA,IM 1054874,KY,61.0,M,Blood clot large in leg DVT and PE both lungs,Not Reported,,Not Reported,Yes,7.0,Not Reported,N,01/15/2021,01/16/2021,1.0,PUB,Lipitor 10 x Daily Glipzide 5 x Daily Vitiman D x Daily Belsomta 10 Nightly Omeprazole daily Flonase Shot of .75 for diabetes Trulicoty,Diabetes,Back problems sciatica,,Nome,"['Deep vein thrombosis', 'Pulmonary embolism', 'Thrombosis']",2,PFIZER\BIONTECH,SYR 1054876,CA,89.0,F,Loss of strength/movement below the waist. Admitted to hospital. Physical and occupational therapy administered. Normal strength/movement fully restored.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/19/2021,02/20/2021,1.0,PUB,Atenolol 25mg x2 Lisinopril 40mg x1 Amlodipine Besylate 5mg x1 Calcium 600mg with Vitamin D3 10mcg x1 Super B Complex with Vitamin C OTC x1,Arthritis Hypertension,Arthritis Hypertension,,None,"['Asthenia', 'Mobility decreased']",2,MODERNA,SYR 1054885,NY,60.0,F,"As per Dr: 60 year old woman with history of MVA and back pain presents to office today with left arm pain and discomfort that started three weeks ago and has resolved but left her with tingling sensation in her third, fourth, and fifth digits on her left hand, symptoms started three weeks ago, hours after getting her COVID-19 vaccine. About a week and a half ago she began feeling numbness of her right leg going up to her upper abdomen with progressively worsening symptoms that have stabilized in the past several days. She also feels that her walking is off but cannot quite describe how or when it started. Exam notable for left-sided cervical myelopathy and decreased sensation on her right side up to a mid-thoracic sensory level. Of note she has a first cousin on her fathers side with multiple sclerosis and a more distant cousin on her mother's side with multiple sclerosis. Father with Parkinson's disease. I see that COVID-19 biofire came back positive. In light of this, COVID myelopathy is on the differential",Not Reported,,Not Reported,Yes,,Not Reported,,01/21/2021,01/21/2021,0.0,PVT,,,,,Penicillin soft shell crabs,"['COVID-19', 'Gait disturbance', 'Hypoaesthesia', 'Limb discomfort', 'Myelopathy', 'Pain in extremity', 'Paraesthesia', 'SARS-CoV-2 test positive', 'Sensory loss']",1,PFIZER\BIONTECH,IM 1054886,FL,69.0,F,"Within 20-minutes of vaccination, the patient reported pain in their throat, SOB, tingling in their arms, and chest pressure. EMS evaluated patient on-site. Patient was hypertensive (184/96). 12-lead EKG was NSR, rate of 79 bpm, no ST elevation. FSBG was 137 mg/dL. ETCO2 was 40mmHg with normal square waveform. EMS initiated transport to Hospital Emergency Department. En route, patient became more hypertensive (200/106). In ED, she remained hypertensive and was admitted to inpatient telemetry unit. Patient had 1-night stay to rule out cardiac-related events. Anaphylaxis was ruled out. Discharged with diagnosis of vaccine reaction and chest tightness.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/24/2021,02/24/2021,0.0,OTH,"Atorvastatin, Carvedilol, Gabapentin, Insulin, Isosorbide dinitrate, Triamterene",None reported,"HTN, OSA, Type 2 Diabetes",,"Aspirin, Latex, Codeine","['Activated partial thromboplastin time normal', 'Blood glucose normal', 'Brain natriuretic peptide normal', 'Cardiac failure congestive', 'Cardiomegaly', 'Chest X-ray abnormal', 'Chest discomfort', 'Dyspnoea', 'Electrocardiogram normal', 'Full blood count normal', 'Hypertension', 'International normalised ratio normal', 'Metabolic function test normal', 'Oropharyngeal pain', 'Paraesthesia', 'Pneumonia', 'Prothrombin time normal', 'Troponin normal', 'Vaccination complication']",1,PFIZER\BIONTECH,IM 1054896,,94.0,M,"Admitted to hospital on 2/24/21 with shortness of breath, lower extremity edema, coagulopathy. Hx of CHF. COVID test negative",Not Reported,,Not Reported,Yes,,Not Reported,,02/18/2021,02/19/2021,1.0,PVT,,,,,,"['Coagulopathy', 'Dyspnoea', 'Oedema peripheral', 'SARS-CoV-2 test negative']",UNK,PFIZER\BIONTECH,IM 1054908,,58.0,M,"After second Moderns COVID -19 vaccine, along with fever and body aches, individual also experienced chest pain, which he called 911 for. He was kept in hospital for observation x 24 hours, and released with dx of chest pains r/t body aches from vaccine. He states no long-term concerns.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/12/2021,02/13/2021,1.0,UNK,,,,,,"['Chest pain', 'Pain', 'Pyrexia']",2,MODERNA,IM 1054924,IN,42.0,F,Ischemic stroke,Not Reported,,Yes,Yes,9.0,Yes,N,02/11/2021,02/13/2021,2.0,PUB,"Methotrexate, plaquenil, valacyclovir, aspirin,","Lupus, herpetic stomatitis began after first vaccine dose on 12/22/2020",Lupus,,"Egg, Penicillin, cipro, Augmentin","['Computerised tomogram head', 'Ischaemic stroke', 'Magnetic resonance imaging brain']",UNK,PFIZER\BIONTECH,IM 1054947,CA,77.0,F,"Presented to the ER with complaints of fever, shortness of breath including nausea vomiting and diarrhea. She started getting ill after receiving her second dose of the Pfizer Covid vaccine. Admitted to hospital for 2 day stay.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/12/2021,02/17/2021,5.0,PVT,warfarin (COUMADIN) 2.5 MG Tab levoFLOXacin (LEVAQUIN) 500 MG tablet warfarin (COUMADIN) 5 MG Tab albuterol 108 (90 Base) MCG/ACT Aero Soln inhalation aerosol levothyroxine (SYNTHROID) 100 MCG Tab acetaminophen (TYLENOL) 500 MG Tab Sennosid,DVT,"asthma, insulin-dependent diabetic",,"Statins [Hmg-coa-r Inhibitors] Swelling High 2/17/2016 Cephalosporins Rash, Swelling Not Specified 1/23/2015 Cillins [Penicillins] Swelling Not Specified 1/23/2015 Penicillin G Not Specified Systemic 11/13/2015 Reglan [Metoclopramide] Anxiety Not Specified 1/23/2015","['COVID-19', 'Diarrhoea', 'Dyspnoea', 'Malaise', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test positive', 'Vomiting']",2,PFIZER\BIONTECH,IM 1054963,CA,73.0,F,"Paralyzed right side of face (possible Bells Palsy), predisone, right side of face will not move, eye will not close, unable to smile, condition is unchanged.",Not Reported,,Not Reported,Yes,2.0,Yes,N,02/01/2021,02/23/2021,22.0,OTH,Amlodipine Gabapentin Clonazapam Protonix Imodium Citrucel,Breast cancer...no treatment has begun at this point,Simple partial seizures,,None,"['Blood test', 'Computerised tomogram', 'Dyskinesia', 'Echocardiogram', 'Eye movement disorder', 'Eyelid function disorder', 'Facial paralysis', 'Facial paresis', 'Magnetic resonance imaging']",1,MODERNA,IM 1054966,NC,79.0,M,Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration,Yes,02/21/2021,Not Reported,Yes,5.0,Not Reported,N,02/12/2021,02/16/2021,4.0,PVT,Albuterol inhaler Allopurinol Aspirin Carvedilol Cyanocobalamin Escitalopram Fanny Cream Fluticasone nasal spray Furosemide Glipizide Insulin detemir Ipratropium/albuterol nebs Losartan Melatonin Metformin Olanzapine Fish oil Pravastatin Ps,None. Recently in hospital for a fall.,"Dementia, atrial fibrillation, type 2 diabetes, heart failure with reduced ejection fraction, gout, hyperlipidemia",,None,"['Abdominal pain', 'Angiogram pulmonary normal', 'Apnoeic attack', 'Blood creatine', 'Blood creatine phosphokinase increased', 'Blood potassium normal', 'Blood urea increased', 'CSF glucose increased', 'CSF protein increased', 'Cardiac failure congestive', 'Chest X-ray abnormal', 'Computerised tomogram head normal', 'Decreased appetite', 'Dehydration', 'Fibrin D dimer increased', 'Glomerular filtration rate decreased', 'Hypophagia', 'Protein total increased', 'SARS-CoV-2 test negative', 'Tenderness']",2,MODERNA,IM 1054972,CO,49.0,M,"Presumed partial myelitis, clinical diagnosis. Underwent 3 days of high-dose IV methylprednisolone followed by PLEX x5 exchanges",Not Reported,,Not Reported,Yes,,Yes,N,02/11/2021,02/12/2021,1.0,PVT,"Multivitamin, Tylenol, ibuprofen, flonase",none,bullet in T10 vertebra,,NKDA,['Myelitis'],2,MODERNA,IM 1054984,NE,77.0,M,"Increased weakness, fell twice at home. Unable to get back into bed. Admitted to observation status at hospital for weakness for until 2/23 when transferred to skilled care. On day of admission, patient was 2 assist when normally he was independent. IV fluids D51/2 normal at 75/hr",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/20/2021,02/21/2021,1.0,PVT,"Carvedilol, glipizide, aspirin, metformin, omeprazole, mirtazapine, quetiapine, simvastatin, Tylenol,",,"BPH, CAD, CKD, degenerative spondylolithesis, diabetes, hypertension, ischemic myocardial dysfunction, lumbar back pain, sever major depression",,Naproxen,"['Asthenia', 'Blood alkaline phosphatase increased', 'Blood creatinine increased', 'Blood urea increased', 'Fall', 'Haemoglobin decreased', 'Mobility decreased', 'Neutrophil count normal', 'Urine analysis normal']",1,MODERNA,IM 1054991,,38.0,M,"Per Dr.'s admit note: ""Etiology unclear though favor meningitis/encephalitis given 2 days of viral symptoms, headache, questionable neck pain, and low-grade fever of 100.6. Had first COVID-19 vaccination on 2/13. Cannot exclude paraneoplastic syndrome; possible hilar mass noted on CXR will need further work-up to rule out sarcoid/malignancy. Concern for viral meningitis. No known sick contacts. Another tonic-clonic seizure occurred around 08:00 on 2/24 AM with vomiting; no overt aspiration though certainly high risk given situation.""",Not Reported,,Not Reported,Yes,,Not Reported,N,02/13/2021,02/23/2021,10.0,UNK,,,,,,"['Chest X-ray abnormal', 'Encephalitis', 'Generalised tonic-clonic seizure', 'Headache', 'Meningitis', 'Neck pain', 'Paraneoplastic syndrome', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,IM 1055003,TX,16.0,F,"1. 48 hours after the first vaccine dose, she developed a raised, red, bump ~4-5cm area on her back with irregular borders. It was slightly itchy but not painful. 2. The area on her back worsened over the next 2-3 weeks and developed dark black scabs. 3. 24 hours after the second vaccine dose (which was given on 2/20/21), she developed scattered lesions on her neck, hairline, ear, face ? some with blisters, some with scabbed tops. Again slightly itchy but not painful. She also had a transient headache and chills that resolved on their own that same day.",Not Reported,,Yes,Yes,,Not Reported,N,01/30/2021,02/01/2021,2.0,PVT,"prednisone, mercaptopurine, methotrexate, vincristine, trimethoprim-sulfamethoxazole, norethindrone, cholecalciferol, calcium carbonate, famotidine",currently undergoing chemotherapy for B cell acute lymphoblastic leukemia,B cell acute lymphoblastic leukemia,,shellfish and platelet blood products,"['Biopsy skin', 'Chills', 'Erythema', 'Headache', 'Pruritus', 'Rash papular', 'Scab', 'Skin discolouration', 'Skin lesion', 'Swelling']",1,PFIZER\BIONTECH,IM 1055009,IL,87.0,M,Patient deceased 2/9/2021 when called for second dose vaccine appointment,Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,,02/04/2021,02/09/2021,5.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1055021,IL,77.0,F,"Fever, syncope. Pt has small rash to administration site.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/24/2021,02/25/2021,1.0,PVT,ALOE VERA JUICE Liquid aspirin 325 MG Tablet CALCIUM CITRATE-VITAMIN D PO Coenzyme Q10 (CO Q-10) 100 MG PO CAPS dilTIAZem (CARDIZEM CD) 240 MG CAPSULE SR 24 HR dorzolamide-timolol (COSOPT) 22.3-6.8 MG/ML Solution esomeprazole (NEXIUM) 20 MG,"AF (paroxysmal atrial fibrillation) () HTN (hypertension), benign MVP (mitral valve prolapse) Interstitial cystitis GERD (gastroesophageal reflux disease) Acquired hypothyroidism SBE (subacute bacterial endocarditis) prophylaxis candidate Low back pain Chronic neck and back pain H/O colonoscopy Nonsmoker Fibromyalgia muscle pain Anticoagulation monitoring, INR range 2-3 Recurrent UTI Primary osteoarthritis of right knee Primary osteoarthritis of right hip",as above,,Alphagan P [Brimonidine Tartrate] Anticoagulant Compound Sulfa Antibiotics Tetracyclines & Related Sulfamethoxazole-trimethoprim Tetracycline,"['Blood test normal', 'Injection site rash', 'Pyrexia', 'Syncope']",2,PFIZER\BIONTECH,IM 1055027,IL,81.0,M,patient deceased no show to 2nd appointment notified by family,Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,,01/29/2021,02/15/2021,17.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1055044,,79.0,M,Patient experienced generalized weakness and inability to ambulate. He presented to the ER on 2/24/21 and was found to be hypoxic 88% on room air and was stated on O2. He presented with a rash at site of vaccination on left arm over deltoid muscle. He had a red petechial rash on anterior chest and upper abdominal wall.,Not Reported,,Not Reported,Yes,,Not Reported,,02/23/2021,02/24/2021,1.0,UNK,,,,,,"['Asthenia', 'Gait inability', 'Hypoxia', 'Petechiae', 'Vaccination site rash']",UNK,MODERNA, 1055048,GA,80.0,M,"Six hours after receiving the Moderna vaccine, the patient experienced palpitations and had a pulse rate between 115 and 130. He was seen in the ER and it was determined that he was in a.fib.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/24/2021,02/24/2021,0.0,PVT,Aspirin 81mg po daily Diazepam 5mg po bedtime Lasix 40mg po daily as needed Gabapentin 100mg po twice a day Lisinopril 10mg po daily Nexium 40mg po bedtime Potassium chloride 10mEq po daily as needed Pravastatin 40mg po daily Ultram 50mg po,,"H/O of HTN, GERD, ascending aortic aneurysm, dyslipidemia, generalized anxiety",,NKDA NKFA,"['Atrial fibrillation', 'Electrocardiogram', 'Heart rate increased', 'Palpitations']",2,MODERNA,IM 1055062,CA,27.0,F,10 minutes post 2nd vaccination patient passed out and had shortness of breath. Patient was administered Epi via Epipen and transported to the hospital.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/24/2021,02/24/2021,0.0,OTH,,,Anxiety,,"Pork, peanuts and sesame seeds","['Dyspnoea', 'Loss of consciousness']",2,MODERNA,IM 1055070,OR,41.0,F,Client died on 02/21/2021 and had received the second dose of the vaccine series on 02/19/2021.,Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/21/2021,2.0,PVT,"Cetirizine, ferrous gluconate, atorvastatin, acetaminophen, aspirin EC, sertraline, clozapine, risperidone, clozapine, polyethylene glycol, sennosides, glipizide, levothyroxine,","Morbid obesity, hypothyroidism, Diabetes, Iron deficiency anemia, QT prolongation, hyperlipidemia, chronic hypoxia, psychosis, luteal phase dysphoria, anxiety, early onset schizophrenia, moderate intellectual disability, left ankle ORIF.","Same as item 11, remove left ankle ORIF",,No known allergies,['Death'],2,MODERNA,IM 1055072,IL,75.0,F,"Confusion, falling, inability to complete sentence",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/16/2021,02/17/2021,1.0,PUB,,None,,,,"['Confusional state', 'Fall', 'Lack of spontaneous speech']",1,MODERNA,IM 1055086,,85.0,F,"""Patient with a PMH of HTN, Afib RVR (on Eliquis), nonischemic CMO, HFrEF (EF 25%), HLD, HLD, Fe deficiency anemia, Pulmonary HTN, rectus sheath hematoma presented to ED with LUE edema and pain that started a couple of hours after second dose of COVID vaccine adminstration. Patient had received COVID vaccine shortly after noon day prior to admit on RUE. She reports that she had been experiencing some nausea as well. She was admitted to the hospital for overnight observation secondary to transient alteration of awareness after she presented to the ED for arm swelling where experienced a syncopal episode lasting approximately 1 minute. She was monitored on cardiac tele which showed Afib with appropriate rate control overnight. For her left upper extremity swelling an U/S was done which was negative for thrombus, only a hematoma. Her arm pain was controlled and supportive with a compress. Patient had no further syncope, Afib rate controlled, and hemodynamically stable. Discharged home 2/24/21.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/23/2021,02/23/2021,0.0,UNK,Eliquis,,"HTN, Afib RVR (on Eliquis), nonischemic CMO, HFrEF (EF 25%), HLD, HLD, Fe deficiency anemia, Pulmonary HTN, rectus sheath hematoma",,CEPHALEXIN; CIPROFLOXACIN; CODEINE; TRAMADOL,"['Altered state of consciousness', 'Atrial fibrillation', 'Condition aggravated', 'Haematoma', 'Iron deficiency anaemia', 'Nausea', 'Oedema peripheral', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Syncope', 'Ultrasound Doppler']",2,PFIZER\BIONTECH, 1055107,,91.0,F,No documented vaccine reaction Hospitalized due to co-morbities,Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,,12/29/2020,01/15/2021,17.0,UNK,,,,,,"['Death', 'Multimorbidity']",UNK,PFIZER\BIONTECH, 1055122,ID,88.0,F,"Pale, Short of Breath, Hypoxic, Lethargic within minutes became unresponsive and died.",Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,SEN,"Loperamide , Tylenol 500mg, Acidophilus, Alka-Seltzer, Citalopram, D-Mannose, Docusate, Ensure, Losartan, MacuHealth, Naproxen, Omeprazole, Refresh tears, Gas X, Vagisil,","Nausea, Vomiting, Diarrhea on 2/19","Macular Degeneration, HTN",,No Known Allergies,"['Death', 'Dyspnoea', 'Hypoxia', 'Lethargy', 'Pallor', 'Unresponsive to stimuli']",UNK,PFIZER\BIONTECH,IM 1055128,,81.0,M,"Patient presented to ED due to AMS, syncope. Wife reported that he became confused with generalized weakness and dropped his food on the floor and became unresponsive with his eyes and mouth open. Patient was febrile to 103 on admission w/o leukocytosis. He was admitted to hospital medicine for acute encephalopathy with associated loss of consciousness. Neurosurgery consulted but no neurosurgical intervention needed. Patient improved & discharged home 2/24/21.",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,02/19/2021,02/20/2021,1.0,UNK,AEDs,,"BPH, nephropathy CKD, chronic IDA, DM, GERD, glaucoma, HTN, seizure disorder",,AMLODIPINE,"['Asthenia', 'Body temperature increased', 'Computerised tomogram head', 'Confusional state', 'Encephalopathy', 'Loss of consciousness', 'Magnetic resonance imaging brain', 'Mental status changes', 'Pyrexia', 'Syncope', 'Unresponsive to stimuli']",2,MODERNA, 1055137,NC,93.0,M,Pt admitted w/ severe COVID diagnosis on 2/20/2021.,Not Reported,,Yes,Yes,,Not Reported,N,02/02/2021,02/20/2021,18.0,OTH,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 1055149,MI,95.0,M,"This is a hospice patient under the care of Hospice at an affiliated nursing home. Pt received the vaccination around noon on 2-16-21 by a representative from Pharmacy. The following afternoon 2-17-21 at 14:45 the pt started to experience severe SOB resp rate 36, audible wheezing and use of respiratory accessory muscles. BP180/80, 113 pulse temp 98. Pt was given morphine and ativan. The respiratory distress was eased however pt never returned to baseline and died 2-22-21 around 4am.",Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,SEN,"Amlodipine, lasix, toprol XL, PRN: lorazipam and morphine","MEDICAL HISTORY; CHF (EF=20%), CAD, AAA (NO REPAIR) 5.3CM, ANEMIA (HISTORY TRANSFUSIONS ARANESP/PROCRIT), CKD STAGE 5 (BUN=110/CREATININE=6.09), HTN, ISCHEMIC CARDIOMYOPATHY, GLAUCOMA, HOH, COVID-19 PNEUMONIA 11-27-2020 THROUGH 12-12-2020, SEVERE NONRHEUMATIC MITRAL VALVE REGURGITATION, NSTEMI 03-27-2019, CAROTID ARTERY STENOSIS, CABG 2009, CARDIAC STENT PLACEMENT, FORMER SMOKER.",see above,,"ace inhibitors, codeine, lysynopril","['Death', 'Dyspnoea', 'Respiratory distress', 'Use of accessory respiratory muscles', 'Wheezing']",2,MODERNA,IM 1055153,IL,79.0,M,"Pt received COVID injection at doctors office. Approximately 1 hour later while sitting in recliner, wife noticed patient pale and unarousable. Paramedics were called and found patient with agonal respirations in asystole. Pt was intubated, received epinephrine, amiodarone and atropine per ALS care. Pt wife stated patient complained of dizziness and headache, but no chest pain or shortness of breath. Pt transported to ER. Following testing and treatment in ER, pt transferred to ICU.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/24/2021,02/24/2021,0.0,PVT,,,"Paroxysmal atrial fibrillation, pre diabetes, obesity, congestive heart failure, CAD, with stent placement essential hypertension, high cholesterol,",,Bee venom Sulfamethoxazole w/trimethoprim,"['Blood gases', 'Cardiac arrest', 'Chest X-ray', 'Chest pain', 'Computerised tomogram head', 'Depressed level of consciousness', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Endotracheal intubation', 'Fibrin D dimer', 'Full blood count', 'Glycosylated haemoglobin', 'Headache', 'Intensive care', 'Metabolic function test', 'Pallor', 'Troponin', 'Unresponsive to stimuli', 'Urine analysis', 'X-ray']",2,MODERNA,IM 1055156,ME,55.0,F,"same day of injection - large area of swelling 6 cm, vomiting, high fever, chills, hallucinations, severe joint pain , fatigue, discoloration and pain in hands.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/17/2021,02/17/2021,0.0,OTH,aspirin and multi-vitamin,none,anticardiolipin antibody syndrome,,NKDA,"['Anti-cyclic citrullinated peptide antibody negative', 'Antinuclear antibody increased', 'Arthralgia', 'Blood creatine phosphokinase normal', 'C-reactive protein normal', 'Chills', 'Fatigue', 'Full blood count normal', 'Hallucination', 'Metabolic function test normal', 'Pain in extremity', 'Pyrexia', 'Red blood cell sedimentation rate increased', 'Rheumatoid factor negative', 'Skin discolouration', 'Swelling', 'Vomiting']",2,MODERNA,IM 1055173,NC,91.0,M,Pt admitted w/ severe COVID diagnosis after receiving 2 doses of vaccine,Not Reported,,Yes,Yes,,Not Reported,N,02/01/2021,02/13/2021,12.0,OTH,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,SYR 1055191,CA,56.0,M,"Fever, bruising on left arm and left leg, fatigue. Went to urgent care, drew labs, low blood count, went to ER. Was given steroids and several plasma transfusions. Was sent home with steroids.",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,01/25/2021,01/27/2021,2.0,PUB,Multivitamin,None,None,,No known allergies,"['Blood count abnormal', 'Computerised tomogram normal', 'Contusion', 'Fatigue', 'Full blood count decreased', 'Full blood count normal', 'Injection site bruising', 'Laboratory test normal', 'Mycobacterium tuberculosis complex test negative', 'Pyrexia', 'Scan bone marrow normal', 'Transfusion', 'Ultrasound spleen']",2,MODERNA,IM 1055194,OH,68.0,F,Profound hearing loss in left ear,Not Reported,,Not Reported,Not Reported,,Yes,N,02/17/2021,02/20/2021,3.0,PUB,Lisinopril Atorvastatin Biosoprolol/hctz 5/6.25 mg Multi vitamin Glucosamine,None,High blood pressure,,Aspirin,['Deafness'],1,PFIZER\BIONTECH,SYR 1055203,OH,67.0,M,"Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632.",Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/18/2021,1.0,PVT,"Metformin, Lisinopril, Atorvastatin, Aspirin, Dulaglutide, Insulin Glargine, Loratadine, Fenofibrate, Fluticasone, Multivitamin",,"Essential hypertension, benign ? Other and unspecified hyperlipidemia ? Hypertrophy of prostate without urinary obstruction and other lower urinary tract symptoms (LUTS) ? Injury of left rotator cuff ? Adhesive capsulitis of left shoulder ? Suppurative otitis media of both ears ? Bronchitis, acute ? Acute myeloid leukemia in remission ? Type 2 diabetes mellitus without complication ? Acute midline low back pain without sciatica ? Sinistrocardia ? Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene, with long-term current use of insulin ? Thrombocytopenia ? Splenomegaly ? Cirrhosis of liver without ascites ? Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene, with long-term current use of insulin ?",,"Cat hair extract, Pollen extract, Mold and Smuts","['Blood lactic acid increased', 'Brain natriuretic peptide increased', 'C-reactive protein increased', 'Clostridium difficile colitis', 'Colitis', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram thorax abnormal', 'Cough', 'Death', 'Dyspnoea', 'Endotracheal intubation', 'Full blood count abnormal', 'Metabolic function test abnormal', 'Pneumonia', 'Sepsis']",1,PFIZER\BIONTECH,IM 1055226,NE,97.0,F,PRESENTED TO HOSPITAL WITH MULTIPLE SYNCOPAL EPISODES THROUGHOUT THE DAY @APPROX 7PM 2/24/21. HAD SEVERAL EPISODES OF ASYSTOLE. CURRENTLY COMPLETE HEART BLOCK. PT HAS DNR AND IS IN HOSPITAL. INFORMATIO PROVIDED BY RN,Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/23/2021,02/24/2021,1.0,SEN,UNK,UNK,,,"TOBRAMYCIN, SUPRAX, PCN, PHENYLEPHRINE, NITROFURANTOIN, LINCOMYCIN, GUAIFENESIN, DIPHENHYDRAMINE, DEXAMETHASONE, CIPROFLOXACIN, CEFTRIAXONE, SULFA ANTIBIOTICS, SULFONAMIDE DERIVATIVES","['Atrioventricular block complete', 'Cardiac arrest', 'Syncope']",2,PFIZER\BIONTECH,IM 1055267,VA,91.0,M,Death,Yes,02/25/2021,Not Reported,Not Reported,,Not Reported,,02/24/2021,02/25/2021,1.0,SEN,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1055268,NY,74.0,M,"Chill, headache, spike in blood pressure, hospitalized overnight",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/19/2021,02/23/2021,4.0,PVT,fosinopril 40 mg 5 mg amolipine,none,skin cancer baisal I was getting a MOSE OPERATION and was injected with epinephrin I ended up in the hostipal the though i was having a hart attack,,shell fish,"['Blood pressure increased', 'Chills', 'Headache']",1,PFIZER\BIONTECH, 1055290,MI,94.0,F,Death occurred 02/14/2021,Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/11/2021,3.0,SEN,not known at this time. I can research if needed,unknown,elderly,,unknown,['Death'],2,MODERNA,SYR 1055294,NC,49.0,F,Patient developed chest pain 5-10 minutes after the first dose requiring hospitalization. I am a hospitalist physician admitting the patient to hospital from the ER.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/25/2021,02/25/2021,0.0,PVT,"Trazodone, lamotrigine, CELEBREX; buspar, levothyroxine, vraylar",,"Bipolar disease, hypothyroidism",,"tetracyclines, wellbutrin","['Chest X-ray normal', 'Chest pain', 'Electrocardiogram normal', 'Troponin normal']",UNK,MODERNA,UN 1055298,IL,71.0,F,"Emergency Room HPI: The patient is a 71 y.o. female with a PMH notable for COPD, hypertension and anxiety and depression who presented on 2/6/2021 for evaluation of shortness of breath. Patient presented to our emergency room yesterday morning from local nursing facility rehab nursing staff reported that she had had a increased shortness of breath for the last 3 days she has been diagnosed with COVID-19 on 2-2-2021. Patient has also received both COVID-19 vaccines. Patient presented to the emergency room with labored respirations conscious awake and was on a non-rebreather at 15 L. upon arrival to our emergency room patient's temperature 101.6�, pulse 169, respirations 40 to blood pressure 142/91 and oxygen saturation 100% on 15 L non-rebreather. Patient received a chest x-ray that showed chronic emphysema and fibrotic changes in the lung no acute processes identified. Patient's white count 12.8, glucose 197, creatinine 1.2, lactic acid 4.6, cardiac enzymes negative, D-dimer 1180, patient has urine culture pending. Patient has received about 3 L normal saline boluses patient was having hypotension 86/52. Patient also received IV acetaminophen a 1000 mg IV in the emergency room along with Decadron 10 mg IV piggyback. Patient was admitted acute care for the need of IV fluids and IV antibiotics for COVID-19 and sepsis 2/12 admit Brief history and initial physical exam: Patient is a 71 year old long-term resident of Rehab and Healthcare. Unfortunately, she contracted coronavirus (COVID-19) at the nursing home. Her respiratory status started to decompensate and so she was brought into the hospital. Initial workup showed significant bilateral pleural effusions and ground-glass opacity of both lungs. She had a significant supplemental oxygen requirement. She was admitted for further evaluation and treatment. � Hospital course: The patient was admitted and started on IV Remdesivir. She was given IV Decadron. She was given immune support vitamins. Despite this, her sepsis worsened. When it became apparent that the patient was not going to recover, her daughter did make her comfort care only and hospice was consulted. The patient was found to be appropriate for general inpatient hospice and was made comfort care. Her requirement for morphine and Ativan did slowly rise. Eventually, the patient did succumb to her respiratory failure. Time of death was called at 10:00 p.m. on February 15, 2021 � Discharge Condition: expired. Presume cause of death with cardiopulmonary arrest secondary to acute respiratory failure secondary to coronavirus (COVID-19) pneumonia � Disposition: Deceased",Yes,02/15/2021,Not Reported,Yes,10.0,Not Reported,,01/20/2021,02/06/2021,17.0,SEN,,,,,,"['Acute respiratory failure', 'Bladder catheterisation', 'Blood creatinine increased', 'Blood glucose increased', 'Blood lactic acid increased', 'Body temperature increased', 'COVID-19', 'COVID-19 pneumonia', 'Cardio-respiratory arrest', 'Chest X-ray abnormal', 'Computerised tomogram abdomen', 'Computerised tomogram head', 'Computerised tomogram thorax', 'Culture urine', 'Death', 'Differential white blood cell count', 'Dyspnoea', 'Emphysema', 'Fibrin D dimer increased', 'Full blood count', 'Glycosylated haemoglobin', 'Hypotension', 'Lung opacity', 'Metabolic function test', 'Myocardial necrosis marker normal', 'Oxygen therapy', 'Physical examination', 'Pleural effusion', 'Pulmonary fibrosis', 'SARS-CoV-2 test positive', 'Scan with contrast', 'Sepsis', 'White blood cell count increased']",UNK,PFIZER\BIONTECH, 1055329,SC,72.0,F,"Resident received her second vaccination on 2/19/21. She was sent to the hospital on 2/20/21 for respiratory distress. We think she aspirated (she has a history of dsyphagia) which caused pneumonia. However, I am reporting this because it was within 24 hours of receiving her vaccine.",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,02/19/2021,02/20/2021,1.0,SEN,"Aspirin, Bupropion, Paxil, Melatonin, Miralax, renal vitamin, Docusate Sodium, Risperdal, Buspirone, Clonazepam, Miconazole Powder,",,,,"Tetracycline, Singulair","['Pneumonia', 'Respiratory distress']",2,MODERNA,IM 1055341,CA,91.0,F,Sudden death two weeks after first dose of vaccine was administered. No previous symptoms or signs. Family opted not to do an autopsy so cause of death (stroke or heart attack) not known.,Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/13/2021,15.0,SEN,,,,,,['Sudden death'],UNK,PFIZER\BIONTECH, 1055368,,28.0,M,"Patient presented with bilateral blurry peripheral vision that resolved over several days. He was found to have P1 PCA stenosis. Additional imaging showed this to be resolved and a normal variant. Additionally, patient diagnosed with myopericarditis. Found to have elevated troponin up to 6, diffuse ST segment elevation on EKG and chest pain. Started on ibuprofen and colchicine with relief. Discharged from the hospital on hospital day 2.",Not Reported,,Not Reported,Yes,3.0,Not Reported,,02/20/2021,02/21/2021,1.0,UNK,Marijuana Vyvanse,None,None,,None,"['Cerebral artery stenosis', 'Chest pain', 'Electrocardiogram ST segment elevation', 'Myocarditis', 'Troponin increased', 'Vision blurred', 'Visual field defect']",2,MODERNA,IM 1055417,IL,91.0,M,"Emergency room HPI Patient is a 91 y.o. male who presents from nursing home with positive coronavirus a and flu A positive tests. Test was done yesterday. Patient sent to ER because of low oxygen saturation. Patient unable to answer or respond to questions. No fever or chills, no cough or shortness of breath and no complaint of pain when patient was moved around. Oxygen saturation on presentation was 89% on room air and went up to 93% on 4 L of oxygen admission: HPI: � Patient is a 91 y.o. male with a history of severe dementia and severe COPD. He currently resides at Rehab. He had a routine coronavirus (COVID-19) test yesterday that was positive. Then, today he started having increasing oxygen requirement. He was not responding to his typical breathing treatments or oxygen and so they sent him in. In the ER he was found to be in some respiratory distress and did require increased oxygen concentration. Once they got him calm down, his oxygen saturation state over 90% with 4 L. His ABG did show an oxygen Saturation of 86% on 4 L. The patient reportedly had coronavirus (COVID-19) several months ago, but then did test positive for both coronavirus (COVID-19) and influenza on rapid testing at the nursing home yesterday. The patient is being admitted due to his increasing oxygen requirement and respiratory distress",Not Reported,,Not Reported,Yes,7.0,Not Reported,,01/20/2021,02/02/2021,13.0,SEN,"Current Outpatient Medications: ? acetaminophen (TYLENOL) 325 MG tablet, Take 650 mg by mouth every 6 hours as needed for Pain, Disp: , Rfl: ? Ascorbic Acid (VITAMIN C) 1000 MG TABS, Take 1,000 mg by mouth daily, Disp: , Rfl: ? aspiri",,,,nka,"['AST/ALT ratio abnormal', 'Alanine aminotransferase normal', 'Aortic arteriosclerosis', 'Atelectasis', 'Blood albumin decreased', 'Blood alkaline phosphatase increased', 'Blood bilirubin normal', 'Blood calcium decreased', 'Blood chloride increased', 'Blood creatinine normal', 'Blood gases abnormal', 'Blood glucose normal', 'Blood potassium normal', 'Blood sodium abnormal', 'Blood sodium increased', 'Blood urea normal', 'Blood urine absent', 'Brain natriuretic peptide increased', 'COVID-19', 'Carbon dioxide normal', 'Chest X-ray abnormal', 'Chills', 'Computerised tomogram thorax abnormal', 'Cystic lung disease', 'Haematocrit decreased', 'Haematocrit normal', 'Haemoglobin decreased', 'Influenza', 'Influenza A virus test positive', 'Lung infiltration', 'Lung opacity', 'Mean cell volume normal', 'Nitrite urine absent', 'Osteopenia', 'Oxygen saturation decreased', 'Platelet count decreased', 'Platelet count normal', 'Pleural effusion', 'Protein urine absent', 'Pulmonary calcification', 'Pyrexia', 'Red blood cell count abnormal', 'Red blood cell count decreased', 'Respiratory distress', 'Respiratory failure', 'SARS-CoV-2 test positive', 'Scan with contrast abnormal', 'Specific gravity urine normal', 'Speech disorder', 'Thyroid mass', 'Unresponsive to stimuli', 'Urine ketone body absent', 'Urine leukocyte esterase', 'White blood cell count decreased', 'White blood cell disorder', 'pH urine normal']",UNK,PFIZER\BIONTECH, 1055418,TN,71.0,F,Patient suffered a stroke and passed away,Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/24/2021,9.0,PHM,"Lisinopril/HCTZ, Prasugrel, Rosuvastatin",,,,"Codeine, Morphine","['Cerebrovascular accident', 'Death']",1,MODERNA,IM 1055443,WV,65.0,M,"within 10 minutes of vaccination (administered 11:50 AM) felt weak and tired, became pale and diaphoretic. Pulse weak, irregular. EMS promptly arrive (1 block away) and transported to Emergency Department (within 1 mile). Found to have new onset atrial flutter with rapid ventricular response and BP systolic 86. Improved with diltiazem. Also treated with diphenhydramine and methlyprednisolone",Not Reported,,Yes,Yes,,Not Reported,,02/25/2021,02/25/2021,0.0,PUB,"cholecalciferol 5,000 unit daily cyanocobalamin 100 micrograms daily Flonase 1 spray each nostril daily losartan 25 mg 2 tablets daily magnesium citrate 100 mg daily vitamin B complex 1 daily",no,muscular dystrophy sleep apnea essential hypertension,,"amoxicillin (hives, urticaria)","['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Asthenia', 'Atrial flutter', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bilirubin increased', 'Blood electrolytes', 'Brain natriuretic peptide', 'Chest X-ray normal', 'Electrocardiogram abnormal', 'Fatigue', 'Full blood count normal', 'Heart rate irregular', 'Hyperhidrosis', 'Hypopnoea', 'Liver function test increased', 'Pallor', 'Pulse abnormal', 'Renal function test', 'Troponin']",1,MODERNA,IM 1055445,OR,48.0,F,"Sudden, spreading, extremely painful joint inflammation starting at the right shoulder, days later the right knee and left middle toe ball joint, followed by the same in left knee. Otherwise healthy person with no preexisting conditions.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/26/2021,02/10/2021,15.0,OTH,None,None,None,,Sensitivity to codeine,"['Arthralgia', 'Arthritis', 'Pain in extremity', 'Spinal X-ray', 'X-ray limb']",1,MODERNA,IM 1055453,WA,77.0,F,NVD dehydrated lead to further kidney failure,Not Reported,,Yes,Yes,2.0,Not Reported,N,02/20/2021,01/31/2021,,UNK,,"dementia,",demetia,,,"['Blood bicarbonate decreased', 'Blood creatinine increased', 'Blood gases abnormal', 'Blood urea increased', 'Dehydration', 'Diarrhoea', 'Nausea', 'PCO2 decreased', 'Renal failure', 'Vomiting']",2,MODERNA,IM 1055459,IL,94.0,M,"2/14 Emergency room HPI Patient is a 94 y.o. male who presents with complaint of cough that started about a week ago, and was seen by primary care provider on the 9th February 2021. Patient was started on Augmentin and has taken it for about 5 days but said the cough is worse and productive of clear sputum. Patient in ER to get checked for pneumonia. Patient denies a fever or chills, shortness of breath, chest pain, nausea vomiting and no headache or dizziness. Transferred to another facility h&pHistory of Present Illness: 94-year-old former smoker with a history of paroxysmal atrial fibrillation not currently on anticoagulation, coronary artery disease, insulin-dependent diabetes, CKD 4, prostate cancer on surveillance, TAVR 2/17, with a son who is a doctor and a caregiver who is a Radiology NP by his report, who presents in transfer from previous Hospital due to a large right pleural effusion. He has had a cough for some time now, but thinks it may have worsened, at least per his caregiver, over the last 4-5 days. He was seen by his PCP on February 9th and placed on Augmentin, but nothing changed. He himself denies being short of breath, having any chest pain, fevers, chills, sweats, change in appetite, abdominal pain, nausea, vomiting, dysuria, diarrhea. Of note, on a chest x-ray in June he had bilateral pleural effusions, and on an MRI in July to investigate a renal mass, he was noted to have a small right-sided pleural effusion. On arrival to facility this morning, he was afebrile, normotensive, had a normal heart rate, sometimes mildly bradycardic, normal respiratory rate and saturations of 97% on room air. Labs demonstrated chronic anemia and thrombocytopenia, stable stage 4 kidney disease creatinine of 2.6, BUN 64, glucose 187. Chest x-ray demonstrated a moderate right pleural effusion, noting that underlying consolidation cannot be excluded. He was also felt to have bibasilar atelectasis. CT of the chest without contrast showed a large right pleural effusion with most of the right lower lobe being collapsed. Superimposed infection could not be excluded. He had a small left pleural effusion with adjacent atelectasis and a small pericardial effusion as well. EKG and procalcitonin were not performed. He was sent to our facility for thoracentesis. On arrival here, vitals remained stable. His bedside RN informed me that upon returning from the bathroom, he appeared to be a bit dyspneic, but the patient himself denies any shortness of breath or ?huffing and puffing?. 2/25 admEd to hospital admission",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/21/2021,02/14/2021,24.0,PVT,"Current Outpatient Medications: ? Alcohol Swabs (ALCOHOL PADS) 70 % PADS, Indications: Diabetes For use with insulin as ordered. DX E11.9, Disp: 100 each, Rfl: 11 ? amoxicillin-clavulanate (AUGMENTIN) 875-125 MG per tablet, Take 1 tablet",,,,sulfa antibiotics,"['Anaemia', 'Aspiration pleural cavity', 'Atelectasis', 'Blood creatinine increased', 'Blood glucose increased', 'Blood urea increased', 'Bradycardia', 'Chest X-ray abnormal', 'Computerised tomogram thorax abnormal', 'Condition aggravated', 'Cough', 'Differential white blood cell count', 'Dyspnoea', 'Full blood count', 'Laboratory test', 'Magnetic resonance imaging abnormal', 'Pericardial effusion', 'Pleural effusion', 'Pneumothorax', 'Productive cough', 'Sputum normal', 'Thrombocytopenia']",UNK,MODERNA,IM 1055467,WA,43.0,F,"About 10 minutes after injection, my throat started feeling really thick - hard to breathe. Felt like I was wheezing. Super shaky and dizzy. I gave myself my epi-pen. I notified them and they took me to ER - IV - Benadryl and Solumedrol . I got really shaky for about an hour afterwards and then they discharged me. It cleared up my throat issues. within 4 days, I had significant shortness of breath again and I was directed to ER Gave me evaluated me for a pulmonary embolism - I did not have one. They gave me Solumedrol again. They gave me a prednisone taper. And then a week after that - or two weeks after - the shortness of breath returned - Dr had me go to ER room again - They gave me another prednisone taper which I'm still on and I have significant fatigue still and 24/7 out of breath still. Currently: Flonase 50 mg - twice a day - Admerdiscus 100 mg - twice a day",Not Reported,,Yes,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,PVT,no,no,asthma; migraines,,sulpha; Compazine; Venergin; Macrobid; latex; penicillin,"['Dizziness', 'Dyspnoea', 'Fatigue', 'Laboratory test', 'Oropharyngeal discomfort', 'Pharyngeal swelling', 'SARS-CoV-2 test negative', 'Tremor', 'Wheezing']",2,PFIZER\BIONTECH,SYR 1055501,AL,54.0,F,"14 days after first dose, high fevers (104.5-103), low platelet count, have had 4 weeks of multiple tests, including CT scans, Lumbar puncture, abnormal lab work with no known cause. High lymphocytes count (abnormal lymphocytes), abnormal red blood cells, high D Dimer, etc.. Most recent labs show Monoclonal paraproteinemia, Im currently waiting to see a hematologist. Have seen internal medicine, infectious disease, rheumatology, . No one can determine the cause of the ongoing symptoms.",Not Reported,,Not Reported,Yes,28.0,Not Reported,N,01/11/2021,01/25/2021,14.0,PVT,Avapro Bystolic,Hypertension- controlled,Hypertension,,Penicillin,"['Computerised tomogram', 'Fibrin D dimer increased', 'Laboratory test abnormal', 'Lumbar puncture', 'Lymphocyte count increased', 'Lymphocyte percentage increased', 'Paraproteinaemia', 'Platelet count decreased', 'Pyrexia', 'Red blood cell abnormality']",1,PFIZER\BIONTECH,IM 1055515,OH,67.0,F,After Injection: Day 1 Foggy and Tried Day 2 Sunday - I woke with both my knees hurting very badly - took Tylinol put on Ice and heat on both knees front & back elevated Day 3 Monday - Bad night of pain Still very painful took Tramdol and Iced - Elevated Day 4 Tuesday - Painful - Could not bend legs couldn't walk - Very Painful & Knees Swollen Called 911 and went to ER (to no relief) given a pain keller x-rays of knees (Fine) Went Home and could barely walk - still Pain Day 5 Still in pain - Called Osteopatic Doctor and will see him next week Knees need drained according to ER? Using a cain to walk! Still Pain.,Not Reported,,Not Reported,Yes,1.0,Yes,N,02/19/2021,02/19/2021,0.0,PVT,,Ear Infection,Blood Clots in both legs Knee Replacements Both Knees Left Ankle Fusion Surgery,,Morfin,"['Arthralgia', 'Fatigue', 'Feeling abnormal', 'Gait inability', 'Joint swelling', 'Mobility decreased', 'Walking aid user', 'X-ray limb normal']",1,MODERNA,SYR 1055536,NC,42.0,F,The staff member was given a Covid-19 vaccination as part of the LTCF Covid-19 clinic scheduled on 2/25/2021. During the 20 minute observation period the patient lost consciousness and begin to have seizure-like shaking. An 0.3mg epi-pen was administered in the lateral thigh. The patient then experienced cardiac arrest at which point nurses from the LTCF began and completed 2 cycles of CPR before the staff member was resuscitated. EMS arrived and assessed the patient. Patient was taken to the hospital for further evaluation.,Not Reported,,Yes,Not Reported,,Not Reported,U,02/25/2021,02/25/2021,0.0,SEN,"unknown, this was part of a LTCF covid clinic",unknown,unknown,,unknown,"['Cardiac arrest', 'Epinephrine', 'Loss of consciousness', 'Resuscitation', 'Seizure like phenomena', 'Tremor']",UNK,MODERNA,IM 1055546,TX,77.0,F,"per patient family report, patient was hospitalized in intensive care unit on a ventillator the day following covid-19 vaccination",Not Reported,,Not Reported,Yes,,Not Reported,U,02/24/2021,02/25/2021,1.0,PVT,"albuterol, budesonide-formoterol, ipratropium-albuterol, warfarin",not known,"copd, ckd3, pvd",,none known,"['Intensive care', 'Mechanical ventilation']",UNK,MODERNA, 1055552,WA,54.0,F,"First nigth sweats , body aches, chills, headache in the morning still not 100% went through the day until eveing headache really bad then chills and shaking uncontroably , body aches and then chest and arm and jaw pain. Hyperventalating , call 911 went to hospital had a levele of Tropion of 4 and went up to 10.5 spent 3 days in Cardovascular unit. I am now on heart medication",Not Reported,,Yes,Yes,4.0,Not Reported,N,02/15/2021,02/15/2021,0.0,PVT,"Stelara, Lexapro Multivit Vit D",,"Arthrities, Ulcertive Colities",,"Codeine, Sulfas","['Blood test', 'Cardiac monitoring', 'Catheterisation cardiac', 'Chest pain', 'Chills', 'Echocardiogram', 'Electrocardiogram', 'Headache', 'Hyperventilation', 'Magnetic resonance imaging', 'Night sweats', 'Pain', 'Pain in extremity', 'Pain in jaw', 'Tremor', 'Troponin increased', 'X-ray']",2,MODERNA,SYR 1055557,SC,78.0,F,"On the 13th had red spot. Got smaller on Saturday, the 20th. On the 21st it came back larger. Went to ER on the 22nd. Was told to take Benadryl and extra strength Tylenol.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/12/2021,02/13/2021,1.0,PVT,none,Asthma,"Asthma, stomach issues",,Augmentin,['Erythema'],1,MODERNA,IM 1055563,WA,93.0,F,"Pt tested positive for COVID-19 on 2/10/2021 and died from illness related to COVID-19 on hospice at home on 2/18/2021, per care facility.",Yes,02/18/2021,Not Reported,Not Reported,,Not Reported,,02/05/2021,02/18/2021,13.0,SEN,,,,,,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1055588,WA,83.0,F,"Pt tested positive for COVID-19 on 2/10/2021 and was hospitalized on 2/15/2021 and deceased on 2/18/2021 at the hospital of admission, per caregiver.",Yes,02/18/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/15/2021,10.0,SEN,,,,,,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1055598,CA,73.0,F,"Patient received Moderna Vaccine on 2/20/21 at pharmacy. She has a history of atrial fibrilation and diastolic heart failure. On 2/23/21 she presented to ED with symptoms of SOB, hypoxia and cough with findings of fluid overload likely due to exacerbation of diastolic heart failure. Also reports of tongue swelling per ED provider (was not witnessed by me) for which she received IM epinepherine, solumedrol, and decadron. She is currently receiving IV diuresis with improvement of high flow nasal canula requirements",Not Reported,,Not Reported,Yes,,Not Reported,,02/20/2021,02/23/2021,3.0,PHM,amiodarone 200mg BID amlodipine 5mg daily eliquis 5mg BID lipitor 20mg daily glimepiride metformin metoprolol pantoprazole,,"history of atrial fibrilation, diabetes, hypertension, diastolic heart failure",,lisinopril allergy,"['Brain natriuretic peptide increased', 'Brain natriuretic peptide normal', 'Cardiac failure congestive', 'Chest X-ray abnormal', 'Condition aggravated', 'Cough', 'Dyspnoea', 'Fluid overload', 'Hypoxia', 'Left ventricular failure', 'Polyuria', 'Pulmonary oedema', 'Swollen tongue']",1,MODERNA,IM 1055606,NY,80.0,F,"hypotension, diaphoresis, dyspnea",Not Reported,,Not Reported,Yes,,Not Reported,U,02/22/2021,02/22/2021,0.0,UNK,"fluticasone, acetamionophen, plaquenil, levothyroxines, omeprazole, atorvastatin, sulfasalazine, Pulmicort, Spiriva, escitalopram, ventolin",,"RA, COPD",,"doxycycline, aspirin","['Dyspnoea', 'Hyperhidrosis', 'Hypotension']",1,MODERNA, 1055613,WA,97.0,F,Pt tested positive for COVID-19 on 2/10/2021 and was deceased on 2/16/2021 per the caregiver.,Yes,02/16/2021,Not Reported,Not Reported,,Not Reported,,02/05/2021,02/10/2021,5.0,SEN,,,,,,"['COVID-19', 'Death']",1,MODERNA,IM 1055618,WA,80.0,F,"Pt tested positive for COVID-19 on 2/10/2021, and was deceased on 2/16/2021 at.",Yes,02/16/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/16/2021,11.0,SEN,,,,,,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1055629,WA,96.0,F,"Pt tested positive for COVID-19 on 2/10/2021, and deceased on 2/12/2021, per caregiver at.",Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/12/2021,7.0,SEN,,,,,,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1055645,FL,41.0,F,Seizure 2 weeks later with overnight hospitalization after not having seizure since 10/2016,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/05/2021,02/18/2021,13.0,OTH,"Esscitalopram 20 mg PO QD, Lamictal 200 mg PO QD, Klonazapam 1mg PO TID PRN, Tizanidine 4mg PO TID PRN, Emgality subd monthly, Tylenol 500mg 1-2 tabs PO PRN, Alleve 220mg PO PRN, Excedrine Migraine PO PRN, Benadryl 50mg PO QHS PRN",Chronic migraine,"Chronic miggraine, Bipolar II, generalized anxiety disorder, left sided TLE",,"Toradol IV push, Compazine","['Cardiac monitoring', 'Computerised tomogram', 'Electrocardiogram', 'Electroencephalogram', 'Laboratory test', 'Magnetic resonance imaging', 'Seizure']",1,PFIZER\BIONTECH,IM 1055656,NY,85.0,F,"On Day 5 (February 21st) after receiving her 2nd COVID vaccine injection, the patient suffered a massive stroke. She was rushed to an ED, arriving within 45 minutes, immediately received TPA treatment and thrombectomy from the right side of her brain. She continues to receive acute treatment inpatient.",Not Reported,,Yes,Yes,10.0,Not Reported,N,02/16/2021,02/21/2021,5.0,PUB,Metoprolol and atorvastatin,"No other illnesses. Very healthy, active, independent. Exercised daily. Lives independently with her husband in a 3 story home.","No chronic or long-standing health conditions. Very healthy, active, and independent.",,"Penicillin, shrimp","['Cerebrovascular accident', 'Plasminogen activator inhibitor', 'Thrombectomy']",2,MODERNA,IM 1055691,MI,93.0,M,"Massive ischemic stroke with aspiration, unable to arouse on the morning of 1/21/2021 and placed on Hospice with death 1/24/2021",Yes,01/24/2021,Not Reported,Yes,4.0,Not Reported,N,01/19/2021,01/20/2021,1.0,PHM,"Zoloft, ASA, Lipitor","dyslipidemia, mild dementia, lumbar stenosis with indwelling suprapubic catheter - no known infection/symptoms of infection",,,,"['Aspiration', 'Death', 'Ischaemic stroke', 'Unresponsive to stimuli']",1,MODERNA,SC 1055729,,89.0,M,"acute hypoxic respiratory failure, aspiration pneumonia, severe hypernatremia, AKI. Died right after admission due to worsening hypoxia and developed pulseless Vtach arrest.",Yes,02/25/2021,Not Reported,Yes,,Not Reported,N,02/01/2021,02/25/2021,24.0,UNK,,,,,,"['Acute kidney injury', 'Cardiac arrest', 'Death', 'Hypernatraemia', 'Hypoxia', 'Pneumonia aspiration', 'Pulse absent', 'Respiratory failure', 'Ventricular tachycardia']",UNK,UNKNOWN MANUFACTURER, 1055735,HI,84.0,M,Patient went into rapid afib at around 8 pm (6 hours after vaccination) Rate up to 180-190. Became hypotensive with BP as low as 76/56. Went to ER. Hospitalized overnight for observation,Not Reported,,Yes,Yes,1.0,Not Reported,Y,01/28/2021,01/28/2021,0.0,OTH,"Sertraline 25 mg daily, Oxybutynin XL 10 mg daily, Finasteride 5 mg daily, Tamsulosin 0.4 mg daily, Brimonidine 0.1% ophthalmic drops 1 drop each eye daily","Hypertension I10.0, Hyperlipidemia E78.5, Paroxysmal atrial fibrillation I48.0, Prediabetes R73.03, Gout M1A.00X0, Mild cognitive impairment 31.84","Hypertension I10.0, Hyperlipidemia E78.5, Paroxysmal atrial fibrillation I48.0, Prediabetes R73.03, Gout M1A.00X0, Mild cognitive impairment 31.84",,none,"['Atrial fibrillation', 'Condition aggravated', 'Hypotension']",1,PFIZER\BIONTECH,IM 1055738,CT,36.0,M,Received 2nd COVID pfizer vaccine approx 11:15am on 2/18/21. No known reaction from first dose on 1/25/21. Woke up morning of 2/19 and observed extensive petechiae and bloody nose consistent with low platelet count and ITP (immune thrombocytopenic purpura). I was previously diagnosed with ITP and platelet count was 262k confirmed by blood work a couple days before 2nd vaccine. Morning after got blood draw confirming platelets dropped to below 1k. Medical emergency and sent to ER. Admitted and received emergency treatment to increase platelet counts. Ended up requiring splenectomy on 2/22/21. Just discharged from hospital. Multiple medical providers advised me to submit report to VAERS.,Not Reported,,Yes,Yes,5.0,Not Reported,U,02/18/2021,02/19/2021,1.0,PUB,Entyvio IV infusion for ulcerative colitis. Prednisone oral 40 mg daily for UC flare. N Plate weekly for ITP.,,Ulcertative colitis and ITP (immune thrombocytopenic purpura),,Minocyline. Lialda/mesalamine,"['Blood test', 'Condition aggravated', 'Epistaxis', 'Immune thrombocytopenia', 'Inappropriate schedule of product administration', 'Petechiae', 'Platelet count decreased', 'Splenectomy']",2,PFIZER\BIONTECH,SYR 1055751,TX,27.0,F,"Patient began feeling nauseous about 30 minutes after vaccine, then dizzy. A few minutes later she appeared to faint and became unresponsive. She did not appear to be breathing and looked cyanotic. Epipen was administered and patient began responding a few moments later. EMS arrived and was taken to the emergency room. Patient reported feeling fine and was back at home around 7 pm.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/25/2021,02/25/2021,0.0,PHM,UNKNOWN,NONE,UNKNOWN,,REPORTED HISTORY OF ANAPHYLAXIS TO TDAP VACCINATION AS AN INFANT,"['Cyanosis', 'Dizziness', 'Nausea', 'Respiratory arrest', 'Syncope', 'Unresponsive to stimuli']",1,MODERNA,IM 1055752,SD,38.0,F,ITP noted appx 4 wks after 1st dose with heavy vaginal bleeding responsive to IVIG and steroids.,Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/08/2021,02/01/2021,24.0,PVT,None,None,None,,None,"['Immune thrombocytopenia', 'Immunoglobulin therapy', 'Platelet count decreased', 'Steroid therapy', 'Vaginal haemorrhage']",1,MODERNA,SC 1055759,CA,61.0,F,"Loss of use right leg. Paralysis, numbness, tingling, severe pain, and muscle spasms. Acute onset without other trauma",Not Reported,,Not Reported,Yes,3.0,Yes,N,01/26/2021,02/10/2021,15.0,PUB,"Synthroid, Duloxetime, Gapapentin","CMT Type 1A Hereditary Neuropathy, Sarcoidosis, Thyroid, Psorasis","CMT Type 1A Hereditary Neuropathy, Sarcoidosis, Thyroid, Psorasis",,"Ampicillin, Eggs","['Computerised tomogram', 'Electromyogram', 'Hypoaesthesia', 'Loss of control of legs', 'Magnetic resonance imaging', 'Muscle spasms', 'Neurological examination', 'Pain', 'Paraesthesia', 'Paralysis', 'Ultrasound scan']",1,PFIZER\BIONTECH,SYR 1055791,IN,82.0,F,Was given without consent from POA patient got severely sick and never recovered later passed away only live 1 month POA did not allow second vaccine to be given just wanted to report this vaccine was given illegal without POA knowledge,Yes,02/15/2021,Yes,Not Reported,,Not Reported,N,01/11/2021,01/15/2021,4.0,SEN,Yes,Yes Dementia,Yes,Hives,Yes,"['Death', 'Illness']",1,MODERNA,SYR 1055811,CA,67.0,F,"I received this vaccine at a walk-in-clinic, called STAT Med. About 12 hours after receiving the vaccine I felt nauseated but finally managed to sleep. The next afternoon on February 23 I became very ill with vomiting and diarrhea all at the same time. I nearly passed out several times. First responders arrived and found my blood pressure to be about 70/30. Got in ambulance and given fluids. Arrived at hospital around 5:15 pm. Got more fluids and numerous blood tests, none of which were very remarkable. My WBC was 17 but nothing else was wrong. Left hospital at 9:00. Physician assumes Covid vaccine cause these side effects.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/22/2021,02/23/2021,1.0,PVT,"On February 21, 2021, I took the following - Paroxetene, Lisinopril, Atorvistatin, Trazodone, Vitamin D3, and 81mg aspirin; On the morning of February 22 I took Lomotil, 2 Extra Strength Tylenol, and Benadryl.",None,I've had Type 2 Diabetes for a little over 20 years.,,"I am allergic to almost all antibiotics except for Clindamycin, and I am allergic to Nalfon. I am also allergic to mangos.","['Blood test normal', 'Diarrhoea', 'Dizziness', 'Hypotension', 'Malaise', 'Nausea', 'Sleep disorder', 'Vomiting', 'White blood cell count']",1,MODERNA,IM 1055819,AZ,83.0,F,"On January 1, 2021, patient was admitted to Medical Center with COVID. Tested positive on January 2, 2021. Spent 10 days in hospital. Once recovered from pneumonia and fever gone, on January 10, 2021, she was transferred to Rehabilitation Center for continued treatment. She spent 16 days there. She developed UTI and CDIF infections and was on/off oxygen. She started physical therapy. She was scheduled to be released to go home on January 27, 2021. On January 26, 2021, the day before going home, Rehabilitation Center gave her the Moderna vaccine. On January 27, the day she went home, she started feeling very weak and couldn't walk. My dad tried lifting her and they both fell to the ground. My dad called 911 and she was taken to Medical Center, with high fever and possible stroke symptoms (which later was negative). Two days later, she had difficulty breathing and was put on a ventilator. She was on a ventilator for about three days. They took it off and she slowly started recovering. The doctors did all kinds of tests (blood clot in lung, heart, etc.) and all was negative. The only thing they could trace it to was an adverse reaction to the vaccine. After spending 11 days at hospital and treating her for various infections, her heart stopped and she passed away suddenly.",Yes,02/08/2021,Not Reported,Yes,39.0,Not Reported,N,01/26/2021,01/27/2021,1.0,OTH,"Taking various meds/antibiotics for UTI, CDIF, high sodium, high blood pressure, diabetes","Treated for COVID pneumonia. Tested positive on Jan 2, 2021. This caused other infections (UTI, CDIF), required oxygen.","Treated underlying conditions for diabetes, high sodium, high blood pressure, kidney disease.",,,"['Asthenia', 'Cardiac arrest', 'Dyspnoea', 'Gait inability', 'Laboratory test normal', 'Mechanical ventilation', 'Pyrexia', 'Sudden death', 'Vaccination complication']",UNK,MODERNA, 1055962,IN,73.0,M,"Seizures, with bad head pain, followed with loss of speech. High with blood cell count, indicating infection, but none found. Was on a breathing, and feeding tube. Was in hospital for one weeks time. Now in a Rehab facility, with loss of memory and balance.",Not Reported,,Yes,Yes,7.0,Yes,N,02/03/2021,02/17/2021,14.0,PHM,,none,Brain Shunt,,none,"['Amnesia', 'Aphasia', 'Balance disorder', 'Blood count abnormal', 'Blood culture', 'Cardiac monitoring', 'Computerised tomogram', 'Dependence on oxygen therapy', 'Electrocardiogram', 'Feeding tube user', 'Headache', 'Infection', 'Magnetic resonance imaging', 'Seizure', 'X-ray']",1,MODERNA,SYR 1059621,MA,71.0,F,"1/14/21 - Resident complained of SOB. SPO2 66% on RA, vs 105/66-96-20 T98.2 O2 administered Pox 97% Binax test revealed (+) COVID results. Resident transferred to COVID wing. Family (HCP) updated and declined transfer to hospital Resident continued with fever, hypoxia and lethargy. Family elected CMO and Hospice notified. Resident died on 1/16/2021 @ 930AM.",Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/14/2021,2.0,SEN,,"Obesity, Diabetes Type 2, Heart Failure, Bipolar Edema, CVA, GERD, Cardiomegaly",See above,,"Daptomycin, Penicillin, Vancomycin, Cipro, Cubicin, Rocephine","['COVID-19', 'Chest X-ray normal', 'Death', 'Dyspnoea', 'Hypoxia', 'Lethargy', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1059622,MA,85.0,M,Resident rec'd COVID vaccine #2 on 02/02/2021 and was hospitalized on 02/03/2021. Diagnosed with UTI & Metabolic Encephalopathy. He was re-admitted to facility on 02/05/2021. On 02/08/2021 resident was found to be unresponsive with small amount of tan emesis in mouth and on bed. CPR initiated and resident was transferred to ER. ER MD notified facility that resident had died.,Yes,02/08/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,,,SEN,"Lipitor Renvela caps, Pantoprazole, Humalog, Midodrine, Neptro caps, Metoprolol, Levemir, Levothyroxine",UTI & metabolic encephalopathy,"Chronic Kidney Di Stage 5 with Renal Dialysis Diabetes Type 2, CHF, H/o Bladder CA, HTN",,Ace Inhibitors,"['Death', 'Metabolic encephalopathy', 'Resuscitation', 'Unresponsive to stimuli', 'Urinary tract infection', 'Vomiting']",2,PFIZER\BIONTECH,IM 1060524,,79.0,M,"Death, unknown cause Narrative: Patient received COVID19 vaccine on 2/23/2021 at 14:27. On 2/24/21, patient's family found patient deceased at 12:08am. The local coroner had called the MC to let us know on 2/24/21 at 12:55am. Coroner did not suspect foul play.",Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/24/2021,1.0,OTH,,,,,,['Death'],2,PFIZER\BIONTECH,IM 1056011,TX,75.0,M,"My grandpa had a stroke on the 15th of February. He claimed he had been feeling ""off"" for a few days, but didn't say anything. A blood clot had formed in his brain. He was doing better and about to go to rehab to strength his right side of his body. On the 22nd he took a turn for the worst. He was having trouble breathing and they sedated and partially paralyzed him to put a tube in his mouth. I believe another blood clot had formed and oxygen wasn't properly going through his body. They could not stabilize him, and he passed away the same day.",Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/10/2021,3.0,UNK,"Blood pressure medication, cholesterol medication, some other vitamins and supplements.",Kidney disease,Kidney disease,,None.,"['Cardiovascular disorder', 'Cerebrovascular accident', 'Death', 'Dyspnoea', 'Endotracheal intubation', 'Feeling abnormal', 'Hemiparesis', 'Sedation', 'Thrombosis']",2,MODERNA, 1056028,MD,42.0,M,"I have a history of auto immune anemia and ITP. I checked with my hematologist when scheduled if I should take the shot. They stated to take it as not enough data was present to prevent me to take. On 02/11, I spoke with doctors onsite and discussed my medical history. They advised to take the shot as not enough data was present to prevent me to take. On 02/14, I noticed bleeding in gums and petechiae at the injection site. I went to hematologist on 02/15, and platelets were at 2,000. I started 60 mg of prednisone immediately on 02/15. By 02/19, took blood sample and eceived one 70g dose of IVIG. Blood results came back on 02/20, and platelets were at 22,000 but did not cover results from after IVIG treatment. Hematologist decided to stop follow up IVIG treatment and stick to 60mg of prednisone daily as in the past my body has reacted well to it. On 02/24, platelet count went to 300,000. I've started to taper prednisone to 50mg and will continue with weekly blood tests to verify that platelets remain strong. Hemoglobin and all over blood levels in the CBC remained normal during this time. Hematologist has advised not to take second Pfizer COVID-19 shot due to risk.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/11/2021,02/14/2021,3.0,OTH,None.,None.,Auto Immune Anemia Immune thrombocytopenia (ITP) Celiac Disease,,Gluten.,"['Application site haemorrhage', 'Full blood count normal', 'Gingival bleeding', 'Haemoglobin normal', 'Immunoglobulin therapy', 'Injection site haemorrhage', 'Platelet count decreased']",1,PFIZER\BIONTECH,SYR 1056048,IL,51.0,F,Severe Loss of hiring in the right ear,Not Reported,,Not Reported,Not Reported,,Yes,N,02/03/2021,02/06/2021,3.0,WRK,"Vitamin B, fish oil, garlic, vitamin C, vitamin D, vitamin mag/cal/zin, melatonin, Prevacid, singular","Secure Vitamin D deficiency, but I was not about it at the time of vaccine",None,"Tetanus, Flu vaccine",Tetanus,"['Acoustic stimulation tests', 'Deafness unilateral', 'Magnetic resonance imaging brain']",UNK,MODERNA,SYR 1056057,MA,71.0,M,"Within 24 hours of vaccination, pt developed soreness in R arm (where vaccine was given), generalized weakness and difficulty ambulating, and became nonverbal. Presented to BMC ED with temp 102.5, HR 119, BP 112/62, 97% RA.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/24/2021,02/25/2021,1.0,UNK,"acetaminophen, atorvastatin, clopidogrel, empagliflozin, levetiracetam, lisinopril, metformin, thiamine, trospium",COVID diagnosed 1/20/2021 (had mild symptoms),"HTN, dyslipidemia, DM type 2, s/p CVA, dysphagia, urinary incontinence",,amlodipine,"['Asthenia', 'Blood creatinine normal', 'Blood lactic acid increased', 'Body temperature increased', 'C-reactive protein', 'C-reactive protein increased', 'Chest X-ray normal', 'Gait disturbance', 'Heart rate increased', 'Injection site pain', 'Lack of spontaneous speech']",UNK,MODERNA, 1056177,NY,32.0,F,"Bells palsy; Pregnancy; A spontaneous report was received from a physician, who was also a 32-year-old female patient who received Moderna's COVID-19 vaccine (mRNA- 1273) during pregnancy and the patient has been diagnosed with Bell's palsy after delivery. The patient's medical history included exercise induced asthma. Products known to have been used by the patient, within two weeks prior to the event, included ascorbic acid/betacarotene/calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide and omeprazole. On 23 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) for the prophylaxis of COVID-19 infection. On 20 JAN 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029L20A) for the prophylaxis of COVID-19 infection. On an unknown date, an ultrasound and quad screen (levels of alpha-fetoprotein (AFP), human chorionic gonadotropin (HCG), estriol and inhibin A in pregnant women's blood) were performed, and the results were normal. There were no complications during the pregnancy. On 01 Feb 2021, the patient delivered the baby. No other delivery or infant details were reported. On 10 Feb 2021, the patient was diagnosed with Bell's palsy. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the reported event, Bell's Palsy, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/23/2020,12/23/2020,0.0,UNK,PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; OMEPRAZOLE,,Medical History/Concurrent Conditions: Exercise induced asthma,,,"['Blood test', 'Exposure during pregnancy', 'Facial paralysis', 'Ultrasound foetal']",2,MODERNA, 1056178,TX,16.0,F,"feeling cold; achy; feverish; they gave vaccine to my 16 year old daughter; A spontaneous report was received from a consumer concerning her daughter, a 16-year-old female patient that received the vaccine/product delivered to a patient of inappropriate age and experienced feeling cold, feverish/pyrexia and achy/pain. The patient's medical history was not provided. Concomitant medications were not provided. On 09 Jan 2021, prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: unreported) in the left arm for the prophylaxis of COVID-19 infection. On 09 Jan 2021, the patient experienced feeling cold, feverish and achy. Treatment for these events was not provided. Caregiver inquiring as to what to do about second dose. Caregiver REFUSED permission to contact and DOES NOT want the Centers for Disease Control notified. Action taken with mRNA-1273 was not reported. The outcome of the event, received the vaccine/product delivered to a patient of inappropriate age was considered resolved. The events, experienced feeling cold, feverish/pyrexia and achy/pain, was unknown.; Reporter's Comments: This report refers to a case of Product administration error � Product administered to patient of inappropriate age for mRNA-1273, lot # unknown with associated events of feeling cold, Pain ,Pyrexia .Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical history not provided),,,"['Feeling cold', 'Pain', 'Product administered to patient of inappropriate age', 'Pyrexia']",1,MODERNA,OT 1056179,CA,17.0,M,"Gave a 17 year old the vaccine; A spontaneous report was received from a pharmacist concerning a 17-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No concomitant medications were reported. On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 10 Feb 2021, a health care professional gave a 17-year-old the Moderna COVID-19 vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, gave a 17-year-old the vaccine/product administrated to patient of inappropriate age, was considered resolved on 10 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number not provided) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1056180,MI,,U,"Out of specification product administered; A spontaneous report was received from a physician concerning a ""couple"" of patients of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273), who reported the event of ""Out of specification product administered""/MedDRA PT: expired vaccine used. The patients' medical histories were not provided. Concomitant medication use was not provided. On an unspecified date, a ""couple of patients received a dose (unknown which dose) of two planned doses of mRNA-1273 ([LOT number, route and location unknown]) for prophylaxis of COVID-19 infection. A physician reported that ""a couple of patients received their dose at 7 hours"". Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The event of ""Out of specification product administered"" was considered recovered/resolved (date unspecified).; Reporter's Comments: This report refers to a case of Out of specification product administered for mRNA-1273, lot # unknown with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Expired product administered'],1,MODERNA,OT 1056181,IL,,F,"HCP administered the vaccine to a patient under the age of 18; A spontaneous report from USA was received from reporter concerning a under 18 year old female who received Moderna's COVID-19 vaccine (mRNA-1273) by a Health Care Profession. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 January 2021, prior to the onset of the events, the patient received their first dose of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the unknown anatomical location for prophylaxis of COVID-19 infection. There are no recorded events of symptoms experienced by the patient. Laboratory details are unknown. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the given event is unknown.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (under 18 year old female) for mRNA-1273 (lot number 013L20A) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1056182,,16.0,U,"16 Year old patient inadvertently received vaccine; A spontaneous report was received from a pharmacist concerning a 16 year old patient who was administered a COVID vaccine at an inappropriate age. The pharmacist is concerned about 2nd dose recommendations. The patient's medical history was not provided. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on a date not provided intramuscularly for prophylaxis of COVID-19 infection. Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not provided.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1056183,CA,46.0,F,"Severe allergic reactions; Tachychardia; Hypertensive; Blood pressure shut down; Dizzy; Weak; A spontaneous report was received from a consumer concerning a 46 year old, female patient who experienced severe allergic reactions, hypertension, blood pressure shut down, dizzy, weak and tachycardia. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 19-JAN-2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 19-Jan-2021, the patient had tachychardia 130-140, was dizzy and weak, bp shut off. The patient said she was also hypertensive. Treatment for the event included IV fluids, nitroglycerin, aspirin and Benadryl. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the event(s) was not reported.; Reporter's Comments: This case concerns a 46-year-old female hospitalized with serious unexpected events of severe allergic reaction, tachycardia, hypertension, dizziness, asthenia and blood pressure shut down. The events occurred the same day as the first dose of mRNA-1273. Treatment included IVF, nitroglycerin, aspirin and Benadryl. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/19/2021,01/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Asthenia', 'Blood pressure abnormal', 'Dizziness', 'Heart rate', 'Hypersensitivity', 'Hypertension', 'Tachycardia']",1,MODERNA,OT 1056184,,,M,"Swelling in the upper lip (angioedema); A Spontaneous report received from a non-health care professional concerning a unknown year of age male patient who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced angioedema. The patient had already known food and drug allergies. No relevant concomitant medications were reported. On 06 Feb 2021 prior to onset of events the patient received second of two planned doses of COVID-19 (mRNA-1273) vaccine, for prophylaxis of COVID-19 infection. On 09 Feb 2021 patient experienced swelling in upper lip (angioedema). He was in the hospital for a few hours and then discharged. The lip swelling has since subsided. Treatment information was not provided. Action taken in response to mRNA-1273 vaccine events the patient was not applicable. The outcome of event was resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient's history of known food and drug allergies remains confounding factor.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/06/2021,02/09/2021,3.0,UNK,,,Medical History/Concurrent Conditions: Allergy (already known food and drug allergies),,,['Angioedema'],2,MODERNA,OT 1056185,FL,65.0,F,"Next day lost hearing in left ear and getting worse; Feels pressure and ringing in her ear.; Feels pressure and ringing in her ear./ ringing was worsening; Next day lost hearing in left ear and getting worse; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/lot # EL3246) at single dose at right arm on 03Feb2021 16:30 for covid-19 immunisation, because of her age and she had asthma and to protect her elderly and sick parents. Medical history included ongoing ongoing asthma all of her life, ongoing tinnitus 10 years approximately, allergies to everything, environmental allergies, medication, food allergies, contact allergies, ongoing fibromyalgia a decade, ongoing gastrooesophageal reflux disease (GERD) 10-15 years. Family history: father had bladder cancer and going through bowel resection surgery, mother was immunocompromised with polymyalgia rheumatica. Concomitant medication included gabapentin (GABAPENTIN) 200 mg, 1x/day at bedtime) for Fibromyalgia, famotidine (PEPCID) OTC dose in morning and night FOR GERD. After vaccination, towards 04Feb2021 evening, she started losing hearing in her left ear. That was late afternoon. It started with some pressure, and some loss of hearing. By 05Feb2021 it got worse. So she gave herself Sudafed because she was thinking it was normal allergies. By 06Feb2021, it wasn't better. The Sudafed did not seem to help. She went to the Urgent care on 06Feb2021, who told her to go to ENT. She has an ENT appointment on 09Feb2021. The Urgent care prescribed her a short dose of prednisone by mouth 10mg twice a day. She has looked, and not find loss of hearing as a side effect. She hasn't called the doctor yet. The hearing loss has persisted or worsened. It is not constant all day long, but it is there all day long. As of on 09Feb2021, it was pretty bad. On 04Feb2021 she was also experiencing ear ringing. It was a high pitched ring in the same ear. She had tinnitus in both ears, but it was usually low. This one since the pressure started building in her ear, the ringing was louder and bigger. The ringing was worsening. The outcome of events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,UNK,GABAPENTIN; PEPCID [FAMOTIDINE],Asthma (all of her life); Fibromyalgia (a decade); GERD (10-15 years); Tinnitus (10 years approximately),"Medical History/Concurrent Conditions: Allergy (allergies to everything, environmental allergies, medication, food allergies, contact allergies); Bladder cancer (father and going through bowel resection surgery); Contact dermatitis; Drug allergy; Environmental allergy; Food allergy; Gangrene (mother - increasing lower-limb gangrene); Polymyalgia rheumatica (mother)",,,"['Condition aggravated', 'Deafness', 'Ear discomfort', 'Tinnitus']",2,PFIZER\BIONTECH, 1056186,MA,87.0,F,"delirium; fell in the night/fallen; extreme fatigue; memory loss/memory problem prior to getting the vaccine, however, now it was worse; memory loss/memory problem prior to getting the vaccine, however, now it was worse; This is a spontaneous report from contactable other healthcare professionals. An 87-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EN5318), via an unspecified route of administration in the left arm on 01Feb2021 14:00 at a single dose for covid-19 immunization. Medical history included blood pressure abnormal, glaucoma, thyroid problems, mild cognitive impairment and memory problem. Concomitant medication included amlodipine, atorvastatin and carvedilol for blood pressure, donepezil for mild cognitive impairment, ezetimibe, levothyroxine for thyroid problems and ongoing latanoprost for glaucoma. The patient previously received first dose of bnt162b2 (lot number: EL3246) on 11Jan2021 for covid-19 immunization. On an unspecified date in Feb2021, the patient had fallen, did not hit her head, but she has extreme fatigue, memory loss (she has seen some improvement now) unable to be by herself now and take her medications. The patient had a mild case of memory loss and had delirium. The reporter cannot say these events occurred from the vaccine of course. However, the work up that has been done has been negative and reporter was worried. It was reported that the patient had a little memory problem prior to getting the vaccine, however, now it was worse. It was like the patient cannot be alone now. The patient did not have a stroke. However, this like sent the patient over a cliff. This is a life changing event. If patient gets better it's all good, but if she does not they are in big trouble. Patient was previously able to care for self and now she was not able too. Patient underwent lab test (unknown result) in Feb2021. Patient was taken to Urgent Care, was seen by a physician and basic blood work was done and a urine test was done (unknown result). The outcome of event delirium was recovering; all other events was unknown. Information on Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,UNK,AMLODIPINE; ATORVASTATIN; CARVEDILOL; DONEPEZIL; EZETIMIBE; LEVOTHYROXINE; LATANOPROST,,Medical History/Concurrent Conditions: Blood pressure abnormal; Cognitive impairment; Glaucoma; Memory loss; Thyroid disorder,,,"['Amnesia', 'Condition aggravated', 'Delirium', 'Fall', 'Fatigue', 'Urine analysis']",2,PFIZER\BIONTECH, 1056187,NJ,46.0,M,"heart dysrhythmia; period of palpitations; This is a spontaneous report from a contactable nurse (reporting for himself). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/ batch number: EL3246, expiry date unknown), via an unspecified route of administration in the right arm on 05Jan2021, 10:30AM (at 46 years old), at single dose for COVID-19 immunization. The patient's medical history included high cholesterol (treated with statin medications) and seasonal allergies, both from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin, ashwagandha, and ergocalciferol (VIT D). At 46 years old, the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/ batch number and expiry date unknown), via an unspecified route of administration in the left arm on 15Dec2020, 10:00AM at single dose for COVID-19 immunization. The patient has not received other vaccine in four weeks prior to vaccination. Patient did not have COVID prior to vaccination and has not tested for COVID after vaccination. In the morning of 07Jan2021 (approximately 9 am), the patient experienced a period of palpitations, and heart dysrhythmia lasting for approximately 1 hour. The episode resolved on its own and has not returned. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events; patient had echocardiogram, EKG, and 7 days heart monitoring from an unspecified date. The patient recovered from ""heart dysrhythmia"" on 07Jan2021, 10:00AM, and recovered from a period of palpitations an unspecified date. Information on lot/batch number (first dose) has been requested.; Sender's Comments: Based on the available information, a causal relationship between event heart dysrhythmia and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/07/2021,2.0,PVT,ATORVASTATIN; ASHWAGANDHA; VIT D,,Medical History/Concurrent Conditions: High cholesterol (treated with statin medications); Seasonal allergy,,,"['Arrhythmia', 'Cardiac monitoring', 'Echocardiogram', 'Electrocardiogram', 'Palpitations']",2,PFIZER\BIONTECH, 1056188,,,F,"I couldn't re stand; This is a spontaneous report from a contactable pharmacist (patient). A female patient of an unspecified age started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date not reported), via an unspecified route of administration from an unspecified date at a single dose for Covid-19 immunization. The patient medical history included multiple sclerosis (MS). The patient's concomitant medications were not reported. The patient stated she has MS and have both of her Pfizer vaccine doses. She called her doctor and he said it was ok to get the vaccine, even though it had only been 48 days since her IV Immunotherapy. Then the next day his office sent a letter stating to wait 60 days after IV immunotherapy. On an unspecified date, after the first dose, she sat and she couldn't re stand with her Multiple sclerosis. She had to call to help to her with her my wheelchair. She called her HCP and he said to take acetaminophen (TYLENOL) 4x/day and it would get better and it did get better. The dose was similar reaction per caller and she stated she has reported this information to the Pfizer safety dept. The patient stated, she was not even sure it was the vaccine that caused inability to stand for a few hours, with M.S. it could just flare up on it's own. Outcome of the event was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,U,,,,UNK,,,Medical History/Concurrent Conditions: Multiple sclerosis,,,['Dysstasia'],1,PFIZER\BIONTECH, 1056189,,,U,"neutropenia after first dose; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient developed neutropenia after first dose on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported neutropenia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Neutropenia'],1,PFIZER\BIONTECH, 1056190,,,F,"Bell's palsy; chest pains; high blood pressure; This is a spontaneous report from a contactable consumer (patient). A female consumer of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On 05Feb2021, the patient had bad chest pains (she was not sure if she was having a heart attack, as reported), high blood pressure, and Bell's palsy. She was scheduled to have her second dose on 14Feb2021. On unknown date, blood pressure resulted high. The outcome of the events. Information on the LOT/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/24/2021,02/05/2021,12.0,UNK,,,,,,"['Blood pressure measurement', 'Chest pain', 'Facial paralysis', 'Hypertension']",1,PFIZER\BIONTECH, 1056191,,,M,"dehydration; diarrhea; chills; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 as a single dose for COVID-19 immunization. Medical history included Type2 Diabetes and hypertension. The patient's concomitant medications were not reported. On 20Jan2021, one hour after he received the first dose, he experienced chills and went to sleep. Hours later he started to experience diarrhea. The chills lasted for 3 days and the diarrhea lasted for 6 days. He tried taking loperamide hydrochloride (IMODIUM) and bismuth subsalicylate (PEPTO-BISMOL) to treat the diarrhea but it did not work. He went to the hospital and was admitted for dehydration on 25Jan2021. The patient reported that his primary care physician was not convinced that it was caused by the vaccine. He was to receive the second dose of the vaccine today but was wanting to know if that was ok based on his side effects. The clinical outcome of the event dehydration was unknown; chills was recovered on 23Jan2021; and diarrhea was recovered on an unknown date in Jan2021. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/20/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Hypertension; Type 2 diabetes mellitus,,,"['Chills', 'Dehydration', 'Diarrhoea']",1,PFIZER\BIONTECH, 1056192,VA,30.0,M,"Left side of face started to droop; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received their second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, expiry date not reported), via an unspecified route of administration on the left arm on 02Feb2021 14:25 at 0.3 mL, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, expiry date not reported) via an unspecified route of administration on the left arm on 14Jan2021 at 0.3 mL, single for COVID-19 immunization. The patient reported that when at work on Sunday 07Feb2021, the left side of his face started to droop at 23:00. No treatment was received for the event. The patient did not recover from the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/07/2021,5.0,PVT,,,,,,['Facial paralysis'],1,PFIZER\BIONTECH, 1056193,NC,70.0,F,"fainted twice while visiting the bathroom; BP was 145/85; arm was sore; This is a spontaneous report from a contactable consumer reporting for herself. A 70-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot_number m000007217771.CSN20 447277212), via an unspecified route of administration in left arm on 11Feb2021 16:45 at single dose for covid-19 immunisation at Public Health Clinic/Veterans Administration facility. Medical history included hypertension, blood cholesterol increased, anxiety, allergies, allergies to penicillin, Sulfa drugs and Crustacea. The patient previously took tetracycline and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. Concomitant medication included olmesartan medoxomil (unknown manufacturer), diltiazem hydrochloride (unknown manufacturer) and sertraline hydrochloride (SERT). On 12Feb2021 her arm was sore but she was not really feeling anything more. On 13Feb2021 morning at 04:45 the patient fainted twice while visiting the bathroom. Upon checking of the BP it was 121/75. Later in the day the BP was 145/85. The patient was completely normal before the shot. It seems that the vaccine affected my BP. The outcome of the events was recovered in Feb2021. No treatment was performed. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/12/2021,1.0,PUB,OLMESARTAN MEDOXOMIL; DILTIAZEM HYDROCHLORIDE; SERT,,Medical History/Concurrent Conditions: Allergy; Anxiety; Food allergy; High cholesterol; Hypertension; Penicillin allergy; Sulfonamide allergy,,,"['Blood pressure increased', 'Blood pressure measurement', 'Pain in extremity', 'Syncope']",1,PFIZER\BIONTECH, 1056194,MN,39.0,M,"ventricular fibrillation; This is a spontaneous report from a contactable other healthcare professional (HCP) who reported for himself. A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK9231) , intramuscular in right arm on 06Jan2021 at 08:15 (at 39 years) at single dose for COVID-19 immunization. Medical history included mechanical tricuspid valve (as reported) from 2008 and had surgery in 2008 for a tricuspid valve replacement, had a pacemaker, had known allergies to penicillin and contrast dye and unknown blood clotting disorder (as reported, always in therapeutic International normalised ratio (INR) range). Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), lisinopril and warfarin sodium (JANTOVEN). On 13Jan2021 at 09:45 the patient experienced ventricular fibrillation, serious as life threatening illness (immediate risk of death from the event) and due to hospitalization. Event resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care . Nasal Swab on 06Jan2021 was negative. Blood tests done on 21Jan2021 and on 15Feb2021 were both negative. Clinical course was described as follows: Patient had an unknown blood clotting disorder. INR was always in the range of 2.5-3.5 and he took acetylsalicylic acid (BABY ASPIRIN) 3x/week. His heart was 100% paced via a pacemaker. He had surgery in 2008 for a tricuspid valve replacement. A week after he received the first dose of the vaccine, he had ventricular fibrillation that required 25 min of cardiopulmonary resuscitation (CPR) and 6 shocks via defibrillator. He was in the hospital to have a pacemaker replacement and replaced with a new pacemaker/ICD combo. Prolonged time in hospital related to significant trauma to heart, lungs, and liver from prolonged CPR and collapsed lung after initial procedure. Patient was hospitalized for 13 days. Final outcome of the event was not recovering.; Sender's Comments: Event ventricular fibrillation is more likely related to underlying heart disease and unrelated to BNT162B2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,13.0,Not Reported,N,01/06/2021,01/13/2021,7.0,PHM,BABY ASPIRIN; LISINOPRIL; JANTOVEN,,Medical History/Concurrent Conditions: Clotting disorder (always in therapeutic INR range); Contrast media allergy; Pacemaker insertion (cardiac); Penicillin allergy; Tricuspid valve disease; Tricuspid valve replacement (surgery),,,"['Blood test', 'International normalised ratio', 'SARS-CoV-2 test', 'Ventricular fibrillation']",1,PFIZER\BIONTECH,OT 1056195,,,M,"Extremely severe flu symptoms; terrible testing cough in his chest; This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported, no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extremely severe flu symptoms, terrible testing cough in his chest, had to go to the emergency room (ER) on an unspecified date with outcome of unknown. The adverse event resulted in ER/ department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), hospitalization duration was 2 days. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. No follow-up attempts are possible, information about batch number cannot be obtained.",Not Reported,,Yes,Yes,2.0,Not Reported,U,,,,UNK,,,,,,"['Cough', 'Influenza']",UNK,PFIZER\BIONTECH, 1056196,,,M,"He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan; He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan; his cardiac arrest was caused by an arrhythmia; This is a spontaneous report from contactable pharmacist via Pfizer Sales Representative. A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. Patient had a long history of congenital heart issues. He had been stable and closely monitored for the past 20 years. He had no history of arrhythmia. The patient's concomitant medications were not reported. Patient collapsed due to a cardiac arrest on Friday 15Jan2021 and passed away on 19Jan2021. The doctors feel that his cardiac arrest was caused by an arrhythmia. Reporter reported this through the v safe app. And received a message stating reporter would be contacted by the cdc. After patient passed away reporter replied stop to v safe. But still had not been contacted by anyone. This may or may not be related. Reporter have no way of knowing. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported ""collapsed due to a cardiac arrest"", ""cardiac arrest was caused by an arrhythmia"" and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association. The patient's pre-existing long history of congenital heart issues might have provided alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.; Reported Cause(s) of Death: He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan; his cardiac arrest was caused by an arrhythmia; He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan",Yes,01/19/2021,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/15/2021,4.0,UNK,,,Medical History/Concurrent Conditions: Congenital cardiovascular disorder (He had been stable and closely monitored for the past 20 years. He had no history of arrhythmia.),,,"['Arrhythmia', 'Cardiac arrest', 'Coma']",1,PFIZER\BIONTECH, 1056358,PR,40.0,F,"Paresthesias, on lower extremities and tingling on right arm all day; intermittent numbness; right eye twitching daily; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received the second dose of BNT162B2 (lot number: EG686), intramuscularly in left arm on 12Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took tramadol and experienced drug allergy, and the first dose of BNT162B2 (lot number: GK5730) in left arm for COVID-19 immunisation. The patient experienced parethesias, on lower extremities and tingling on right arm all day, intermittent numbness, right eye twitching daily on 15Jan2021. The patient underwent lab tests and procedures which included nasal swab, COVID test result: Negative on an unspecified date. AE resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received for these events. Patient was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/15/2021,3.0,PVT,,,,,,"['Hypoaesthesia', 'Muscle twitching', 'Paraesthesia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,OT 1056359,PR,52.0,M,"mild headache; tiredness; This is a spontaneous report from a contactable other healthcare professional reported for himself (patient). A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 5130) into right arm on 17Dec2020 10:00 AM at single dose for covid-19 immunization in Public health. Medical history was not reported. Other medications in two weeks included irbesartan (AVAPRO), amlodipine besilate (NORVASC) and HCTZ. No other vaccine in four weeks (Also reported ""other vaccine same date product was PFIZER, other vaccine same date lot number was 1600, other vaccine same date dose number was 2, other vaccine same date vaccine location was Right arm"", pending clarification). Patient experienced mild headache and tiredness on 17Dec2020 07:00 PM. No covid prior vaccination. Covid test post vaccination via Blood test with unknown results. No treatment received. outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,12/17/2020,0.0,PUB,AVAPRO; NORVASC; HCTZ,,,,,"['Fatigue', 'Headache', 'SARS-CoV-2 antibody test']",1,PFIZER\BIONTECH, 1056437,CO,,F,"Injected the Moderna Vaccine into the joint space of proximal head of right humerus/posterior; Pain raditaing from injection site to right hand; local aching pain 5-6(10) at site; Fever; A spontaneous report received from a Consumer concerning, 72-year-old female patient who received 2nd dose of the Moderna COVID-19 vaccine that was not injected into the muscle. /MedDRA PT: [Injection error] ~ The patient's medical history included Asthma. Patient's concomitant was not included. On 05-FEB-2021 date, the patient received their 2nd dose of the two planned doses of mRNA-1273 in right arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Patient stated the she received her 2nd dose of the Moderna COVID 19 vaccine on 05FEB2021 and the person who gave the vaccine, injected the Moderna COVID-19 vaccine into the joint space of proximal head of right humerus/ posterior. Patient stated that the injection was exquisitely painful for 3 days and she had a fever of 101.2. Patient stated that she had local aching pain 5-6(10) days and radiating pain from injection site to right hand for 4 days. Patient stated that she would like to know is the dose invalid since it was not given intramuscularly. Dose she needs to repeat 2nd dose of the vaccine. What are the concerns injecting into tendon/ ligament? Treatment information was not provided/ unknown. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was resolved.; Reporter's Comments: This report refers to a case of inappropriate route of administration with reported non-serious events of pain in extremity, fever, and vaccination site pain. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,Asthma,,,,"['Body temperature', 'Incorrect route of product administration', 'Pain in extremity', 'Pyrexia', 'Vaccination site pain']",2,MODERNA, 1056438,FL,76.0,M,"pneumonia; Tired; Achy; Muscle weakness in left arm; Arm was swollen; This spontaneous report was received on 10FEB2021 from a consumer which refers to a 76-year-old male patient who received the Moderna COVID-19 (mRNA-1273) Vaccine and experienced injection arm swelling, tired, achy, lingering shortness of breath, muscle weakness in the injection arm, and pneumonia. The patient's medical history was not provided. Concomitant medications were not reported. On 15JAN2021, prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 intramuscularly (Lot number: 026L20A). On 16JAN2021, the patient noted a start date for Pneumonia. On 10FEB2021, the patient called the medical information call center and reported, ""he is on antibiotics for pneumonia. His 2nd question is can he delay the 2nd dose since he is suffering from pneumonia. Patient was administered 1st dose of vaccine on 15/Jan/2021 in his left non dominant arm. The lot# was provided, but expiration date is unknown. Patient experienced some expected side effects, which he is not concerned about"". The event(s) were arm swollen, tired, achy, lingering shortness of breath, muscle weakness in the injection arm, and tested positive for pneumonia 1 day after receiving the vaccine. The action taken for Moderna COVID-19 (mRNA-1273) Vaccine was reported by the patient as Tylenol. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start of the events of fatigue, arm swelling, myalgia, muscle weakness, a causal relationship cannot be excluded. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Pneumonia is assessed as unlikely related. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/15/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,"['Fatigue', 'Muscular weakness', 'Myalgia', 'Peripheral swelling', 'Pneumonia']",1,MODERNA,OT 1056439,TX,69.0,M,"Volume difference in syringe from first dose and second dose; A spontaneous report was received from a consumer concerning a 69 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a medication error of volume difference in syringe from 1st and 2nd dose/MedDRA PT: inappropriate dose of vaccine administered. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included tamsulosin, clonazepam, apixaban and metoprolol. The patient received their first of two planned doses of mRNA-1273 (Batch number: 041L20A) on 13 Jan 2021. On 10 Feb 2021, approximately 29 days later, the patient received their second of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient reported that he was told by one person at the facility that both doses were the same; however, he reported that the person who administered the second dose told him that the second dose was a lot higher than the first dose because it was a booster dose and that she showed him the volume difference in the syringe from the first dose and what she would be administering. The patient reported that the amount in the syringe for the second dose was significantly more, but he did not remember the amount from the syringe. The patient was told by a third person at the facility that both doses were the same. The patient did not experience any side effects yet but was concerned and confused if he received a potential overdose. Treatment for the event included none. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was resolved.; Reporter's Comments: This is a case of 69-year-old male patient who was administered volume difference in syringe from 1st and 2nd dose (inappropriate dose of vaccine administered) for mRNA-1273 vaccine Lot # 041L20A. There was no associated adverse event reported for the event of inappropriate dose of vaccine administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,02/10/2021,28.0,UNK,FLOMAX [MORNIFLUMATE]; CLONAZEPAM; ELIQUIS; METOPROLOL,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Accidental overdose'],1,MODERNA,OT 1056440,TN,,U,"mixing vials for quite a few patients to make up missing parts; A spontaneous report was received on 10 FEB 2021 from a pharmacist concerning patient of unspecified age and gender, who received Moderna's COVID-19 vaccine. Patients' medical history was not provided. No relevant concomitant medications were reported. On 27 JAN 2021, patient received their one of two planned doses of mRNA-1273(Lot/ batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection. On 27 JAN 2021, when patient received the vaccine, the reporter stated that her office has been mixing vials of Moderna's COVID-19 vaccine for quite a few patients to make up missing parts. She wanted to know, was it efficient to open a different vial and get parts missing for an already punctured vial to administer. Treatment for the event was not provided. Action taken with the other dose of mRNA-1273 in response to the event was not reported. The outcome of the event, mixing vials for quite a few patients to make up parts, was considered recovered/resolved on 27 JAN 2021.; Reporter's Comments: This report refers to a case of ""Interchange of vaccine products"" for mRNA-1273, lot # unknown, with no associated Adverse Events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Wrong technique in product usage process'],1,MODERNA,OT 1056441,,72.0,F,"Moderate fever; Fatigue; Chills; Patient received first dose 27Jan2021, and second dose 8Feb2021; A spontaneous report was received on 10 FEB 2021 from a pharmacist concerning a 72-year-old, female patient who received Moderna's COVID-19 vaccine first dose on 27 JAN 2021, and second dose on 08 FEB 2021 and experienced moderate fever, fatigue, chills after second dose. The patient's medical history, as reported by pharmacist, include COVID-19 infection. Relevant concomitant medications reported were, include Alendronate � 70 milligram, Aspirin- 81 milligram, Atorvastatin- 40 milligram, Basaglar Insulin, Vitamin D2, Lexapro- 10 milligram, Gabapentin 100 milligram. On 27 JAN 2021, patient received their first of two planned doses of mRNA-1273(BATCH/LOT number: unknown), for the prophylaxis of COVID-19 infection. On 08 FEB 2021, patient received second dose of mRNA-1273(Lot number: unknown), for the prophylaxis of COVID-19 infection. On unknown date, after receiving second dose of mRNA-1273 vaccine, patient experienced moderate fever, fatigue and chills. Treatment for the events were not provided. Action taken the second dose of mRNA-1273 in response to the events were not reported. The outcome of the events, moderate fever, fatigue, chills after second dose, were unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered associated with events of pyrexia, fatigue and chills. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The causality for inappropriate schedule of vaccine administered remains not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,02/08/2021,12.0,UNK,ALENDRONATE; ASPIRIN 81; ATORVASTATIN; BASAGLAR; VITAMIN D2; LEXAPRO; GABAPENTIN,,Medical History/Concurrent Conditions: COVID-19 (Patient had COVID previously.),,,"['Chills', 'Fatigue', 'Inappropriate schedule of product administration', 'Pyrexia']",1,MODERNA,OT 1056442,,,U,"fever; rigors; muscle aches; during administration the barrel broke off from the needle and most of the vaccine leaked out; Needle issue; feeling faint; A spontaneous report was received by a consumer regarding themselves, a patient. Age and sex were not provided. The patient experienced the barrel breaking off the needle and most of the injection leaking out/incomplete dose administration, feeling faint/dizziness, fever/pyrexia, rigors/chills and muscle aches/myalgia. The patient's medical history was not provided. No concomitant medications provided. On 09 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Batch number: not provided) injected into the arm for prophylaxis of COVID-19 infection. The patient received the second injection on 09 Feb 2021 and reported that the needle broke off the barrel during administration, and most of the vaccine leaked out. They reported that the health care provider offered to administer another dose. The patient declined due to feeling faint. On 10 Feb 2021, the patient woke in the middle of the night with a robust immune response that included fever, rigors and muscle aches. Treatment information was not provided. Patient consented to be contacted. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, the barrel breaking off the needle and most of the vaccine leaked out, feeling faint, immune response fever, rigors and muscle aches was considered resolved/recovered.; Reporter's Comments: This report refers to a case of vaccine underdose and needle issue, for mRNA-1273, lot number unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Chills', 'Dizziness', 'Myalgia', 'Needle issue', 'Pyrexia', 'Underdose']",2,MODERNA,OT 1056443,NH,31.0,M,"Some of the vaccine leaked out while administered; Some of the vaccine leaked out while administered; A spontaneous report was received from a nurse concerning a 31-years-old, male patient who experienced some of the vaccine leaked out while administered. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 07 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot number 011m20a) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 07 Feb 2021, the patient experienced some of the vaccine leaking out while being administered. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The outcome of the event some of the vaccine leaked out while administered was unknown.; Reporter's Comments: This report refers to a case of Vaccine underdose and Syringe connection Issue for mRNA-1273 [Lot number 011m20a] with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/07/2021,02/07/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Device connection issue', 'Underdose']",2,MODERNA,OT 1056444,MA,,U,"Did not receive the full dose; A spontaneous report was received from a health care professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive full dose/accidental underdose. The patient's medical history was not provided. No concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, during administration of the Moderna COVID-19 vaccine, the nurse pulled the needle out of the patient's arm too quickly and the patient did not receive the full dose of the vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, did not receive full dose/accidental underdose, was considered resolved.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273(Lot number: not provided) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Accidental underdose'],1,MODERNA,OT 1056445,OR,,M,"Received a lower dose (0.4ml) of the Moderna Vaccine; A spontaneous report was received from a nurse, concerning a 57-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) of lower dose (0.4ml). The patient's medical history was not provided. No concomitant product use was reported. On 08 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A, expiry date: 25-Feb) intramuscularly for prophylaxis of COVID-19 infection. On 08 Feb 2021, a health care professional reported that a patient was given 0.4 milliliters of the Moderna COVID-19 vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, received a lower dose (0.4ml) of the Moderna vaccine, was considered resolved on 08 Feb 2021.; Reporter's Comments: This report refers to a case of accidental underdose for mRNA-1273 (Lot number: 007M20A, expiry date: 25-Feb) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Accidental underdose'],1,MODERNA,OT 1056446,OH,,M,"Received the first shot 10 days before; A spontaneous report was received from a consumer concerning a male patient, of unknown age, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and the patient had received the first shot ten days before/inappropriate schedule of product administration. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 FEB 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly prophylaxis of COVID-19 infection. On 22 FEB 2021, at approximately 09:00 am, the patient received the second dose of Moderna vaccine (Lot number: O3OM2OA). The patient did not feel the vaccine went in, there was no blood on the band aid. The patient had received the first shot ten days before. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event was not applicable. The outcome of event, received the first shot ten days before, was considered as resolved.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273(Lot number: O3OM2OA), with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/10/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Inappropriate schedule of product administration'],2,MODERNA,OT 1056447,NC,,F,"worsening bilateral infraorbital perioral edema; worsening bilateral infraorbital perioral edema; generalized myalgias; fever of 101.6F; A spontaneous report was received from a literature article regarding, a 36-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Circumoral edema, Orbital Edema, myalgia, and fever/pyrexia. The patient's medical history was not included, other than that she was considered a healthy female. Concomitant medications known to have been used by the patient were not included. In November 2019, prior to the vaccination, the patient received hyaluronic acid injections in the tear troughs and in both the upper and lower lip. On 05 Jan 2021, prior to the onset of the events, the patient received the first of two doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 05 Jan 2021, about 12 hours after the vaccine was administered, the patient presented with a fever of 101.6 Fahrenheit and had generalized myalgia. Treatment included acetaminophen. On 06 Jan 2021, the fever and myalgia were resolved. As the day continued, the patient noticed pain and swelling in the right tear trough and increasing swelling around her mouth. On 07 Jan 2021, approximately 36 hours after vaccination, the patient was administered 10 mg of cetirizine. At 48 hours the patient reported that the swelling was at it's peak and she was unable to open her right eye. The patient then took 20 milligrams of cetirizine. Throughout the morning, the left tear trough began to increase, and the rest of her face remained persistently swollen. The patient was administered 5mg lisinopril. Within about 5 hours of dose of lisinopril, the patient reported that swelling had stopped and was decreasing. Over the next 24 hours, edema was improved, and patient returned to baseline. Action taken with mRNA-1273 was not provided. The outcome of the events, circumoral edema, periorbital edema, myalgia and fever, was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Dermal filler injection (Eye trough Upper Lip Lower Lip),,,"['Body temperature increased', 'Circumoral oedema', 'Myalgia', 'Orbital oedema', 'Pyrexia']",1,MODERNA,OT 1056448,MD,,M,"myocarditis; pericarditis; Chest pain; rapid heartbeat; A spontaneous report was received from a 20-year- old male patient who experienced chest pain, myocarditis, pericarditis, inflammation of pericardium. The patient's medical history was not provided. Concomitant medications included phenylpropanolamine, diclofenac sodium, and colchicine. The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 20 Jan 2021 intramuscularly for the prophylaxis of COVID-19 infection. On 30 Jan 2021, the patient experienced chest pain, rapid heartbeat and went to emergency room (ER). He was hospitalized and was diagnosed with myocarditis, pericarditis, inflammation of pericardium. The patient was discharged on 31 Jan 2021. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events, chest pain, myocarditis, pericarditis, inflammation of pericardium, was considered not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. The use of concomitant medication, Pnenylpropanolamine, which is a sympathomimetic agent, is a risk factor and confounding factor for causality.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/20/2021,01/30/2021,10.0,UNK,PHENYLPROPANOLAMINE; ANTI-INFLAMMATORY; COLCHICINE,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Angina pectoris', 'Heart rate increased', 'Myocarditis', 'Pericarditis']",1,MODERNA,OT 1056449,,,F,"Convulsions due to pain; Severe pain; A spontaneous report was received via voicemail from daughter, concerning her mother, a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced convulsions due to pain and severe pain. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, the reported stated her mother experienced severe pain to the point of convulsing. She mentioned her mother was at the doctor. No treatment information provided. The outcome for the event, convulsions due to pain and severe pain, were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Pain', 'Seizure']",1,MODERNA,OT 1056450,MI,,U,"vaccine leaked out during administration of the injection; needle was not snuggly attached to the syringe; A spontaneous report was received from a nurse practitioner concerning a patient (demographics not provided) who received Moderna's COVID-19 vaccine (mRNA-1273), and who experienced needle that was not snuggly attached to the syringe/MedDRA PT: device connection issue and vaccine leaked out during administration of the injection/MedDRA PT: underdose. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 28 Jan 2021, the patient received unknown dose number of mRNA-1273 (Lot # not provided) for prophylaxis of COVID-19 infection. On 28 Jan 2021, upon administering Moderna vaccine, the needle was not snuggly attached to the syringe; therefore, some of the vaccine leaked out. Action taken with mRNA-1273 in response to the events was not provided. The events needle was not snuggly attached to the syringe and vaccine leaked out during administration of the injection were considered resolved on 28 Jan 2021.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Device connection issue', 'Underdose']",1,MODERNA,OT 1056451,GA,,F,"Cellulitis; Arm was sore; A spontaneous report was received from a consumer who was also a 77-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced cellulitis and arm was sore/limb discomfort. The patient's medical history was not provided. Concomitant medication included an unspecified low dose blood pressure medication. On 18Jann2021, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 19 Jan2021, the patient experienced sore arm. On 24Jan2021, the patient experienced itching, swelling and feeling hot at the injection site. The patient was diagnosed with cellulitis and was treated with unspecified antibiotics for 10 days. Action taken with the mRNA-1273 was not reported. The outcome of the events of cellulitis (itching, swelling, hot at the injection site) and limb discomfort was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/19/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Cellulitis', 'Limb discomfort']",1,MODERNA,OT 1056452,MO,79.0,F,"left sided weakness; Stroke like symptoms; Slurred speech; Pneumonia; spontaneous report received from a Consumer concerning, 79-year-old female patient who received the first dose of Moderna COVID-19 vaccine and woke up the next morning not feeling well. /PT: [Not Feeling Well]. The patient's medical history included COPD, hypertension and hyperlipidemia. Patient allergies included sleep medications. Patient's concomitant included Gabapentin, Simvastatin, Advair, Spiriva and Proventil. On 04-FEB-2021, the patient received their first of two planned doses of mRNA-1273 in left arm (Batch #: 016M20A) intramuscularly for prophylaxis of COVID-19 infection. Patient daughter called on behalf of her mother. Patient daughter stated that her mother received the Moderna COVID-19 vaccine on 04FEB2021 and on 05Feb2021 her mother woke up and wasn't feeling well. She stated her mother had weakness on her left side. The daughter stated that ambulance took her mother to hospital. The daughter stated that her mother had stroke like symptoms. The daughter stated her mother had difficulty speaking and slurred speech. The daughter stated the doctor Called it ""Neglect for sensation"". The daughter stated her mother was treated like she had a stroke. The daughter stated that the doctor gave her mother a ""Clot buster"" treatment and it started to normalize. The daughter stated the MRI was negative. She daughter that her mother was still hospitalized and now has pneumonia. Wanted to know if this has been previously reported. Treatment that was given in the hospital was a ""Clot Buster"" Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was unknown/not reported.; Reporter's Comments: The events developed on same day after first dose of mRNA-1372. Hemiparesis, dysarthria, and pneumonia were consistent with increased risk of cerebrovascular accidents related to high blood pressure confounded by elderly age of patient. Very limited information regarding this event/s has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/04/2021,02/05/2021,1.0,UNK,"GABAPENTIN; SIMVASTATIN; FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE; MULTI VITAMINS & MINERALS; TIOTROPIUM BROMIDE; PROVENTIL HFA [SALBUTAMOL SULFATE]",COPD; Drug allergy (Sleep medications); Hyperlipidemia; Hypertension,,,,"['Cerebrovascular accident', 'Dysarthria', 'Hemiparesis', 'Pneumonia']",1,MODERNA,OT 1056453,AL,,F,"sepsis regarding to a cancer; A spontaneous report was received from a consumer concerning an unknown aged female patient. Medical history included unspecified cancer No relevant concomitant medication was reported. On 11Jan2021, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection. On 10 Feb2021, the patient was hospitalized due to sepsis regarding a cancer. No treatment was reported. Action taken with the mRNA-1273 was not reported. The outcome of the event, sepsis, was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. However, patient's medical history of unspecified cancer is a confounding factor that may play a possible contributory role. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/11/2021,02/10/2021,30.0,UNK,,Cancer,,,,['Sepsis'],1,MODERNA,OT 1056454,PA,17.0,F,"17-year-old patient received the first dose of Moderna Covid-19 vaccine; A spontaneous report received from a pharmacist concerning, 17-year-old female patient who has received the first dose of Moderna COVID-19 vaccine The patient's medical history was not included/ unknown. Patient's concomitant was not included/ unknown. On 01-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Reporter stated that a 17 year-old patient received the vaccine. No further information was provided. Treatment information was not provided/ unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was considered resolved on 01 Feb 2021.; Reporter's Comments: This is a case of 17-year-old female patient who was administered mRNA-1273 (product administered to patient of inappropriate age) (Batch #: unknown). There was no associated adverse event reported for the event of product administered to patient of inappropriate age.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1056455,KY,,U,"Received dose in tricep; A spontaneous report received from other Health Professional concerning, unkown age and unknown gender patient who received dose of Moderna COVID-19 vaccine in tricep. The patient's medical history was not included. Patient's concomitant was not included. On unknown date, the patient received their unknown of two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Consumer called in stated that patient received dose of the Moderna COVID-19 vaccine in their tricep. Treatment information was not provided/ unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Incorrect route of product administration'],1,MODERNA, 1056456,NC,,M,"scheduled his 2nd dose on 17March2021 and he knows that's way passed 42 days; A spontaneous report was received from a consumer of unknown age on 11 FEB 2021 stating that he received his 1st Moderna vaccine on 21Jan2021 through the department of health at Goldsboro, North Carolina. They didn't schedule his 2nd dose until 10 FEB 2021. They called him on 10 FEB 2021 and scheduled his 2nd dose on 17 March2021. He knows that's way past 42 days, so he wants to know if that'd still be effective and if he needs to start over the vaccine series. Patient's medical history was not provided. Action taken with mRNA-1273 was not reported. The outcome of the event was unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Inappropriate schedule of product administration'],1,MODERNA,OT 1056457,WI,47.0,F,"axillary lymph node was the size of a golf ball; fever of 101.6 then 102.2; hallucinations; dizziness; confusion; severe headache; body aches; nausea; vomiting; A spontaneous report was received from a healthcare professional concerning a 47 years-old, female patient who experienced hallucinations/MedDRA PT: hallucination, confusion/MedDRA PT: confusion, dizziness/MedDRA PT: dizziness, severe headache/MedDRA PT: headache, body aches/MedDRA PT: myalgia, fever of 101.6 then 102.2/MedDRA PT: pyrexia, nausea/MedDRA PT: nausea, vomiting/MedDRA PT: vomiting, and axillary lymph node was the size of a golf ball/MedDRA PT: vaccination site lymphadenopathy. The patient's medical history was not provided. Concomitant product use included levothyroxine, lisinopril, metformin, liraglutide, atorvastatin, furosemide, famotidine, cetirizine hydrochloride and vitamins NOS. The patient received their first of two planned doses of mRNA-1273 (Lot #007M20A) on 07 Jan 2021. On 03 Feb 2021 at 4:00pm, approximately 4 and a half hours prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot # not provided) intramuscularly, in the left deltoid muscle for prophylaxis of COVID-19 infection. On 03 Feb 2021 at approximately 8:30pm, the patient began to experience severe headache and body aches. By midnight, the patient had a fever of 101.6 then 102.2 which was the highest reading. The patient experienced nausea and vomiting for 36 hours and couldn't keep food down. On Thursday (04 Feb 2021), patient had dizziness, confusion and hallucinations - patient had a conversation with spouse who was not at home. Patient's axillary lymph node was the size of a golf ball. Patient took Tylenol at the 25 hour mark once symptoms began which was about 5:00pm on Thursday. By Friday night (05 Feb 2021) patient was able to keep food down. By Sunday (07 Feb 2021) the patient felt 85% better. The patient still had axillary lymph node swelling but reported 90% improvement. Patient had ongoing headaches at the time of this report for which Tylenol is taken daily. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable. The event severe headache was not resolved. The events hallucinations, confusion, dizziness, body aches, fever of 101.6 then 102.2, nausea, vomiting, and and axillary lymph node was the size of a golf ball were resolving.; Reporter's Comments: This case concerns a 47-year-old female with serious expected Hallucinations, NS unexpected confusion, dizziness and NS expected fever, headache, myalgia, nausea, vomiting, vaccination site lymphadenopathy. Event onset 29 days after first dose and 4 hours after second dose mRNA-1273. Treatment with Tylenol. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,02/03/2021,27.0,UNK,LEVOTHYROXINE; LISINOPRIL; METFORMIN; LIRAGLUTIDE; ATORVASTATIN; FUROSEMIDE; FAMOTIDINE; CETIRIZINE HYDROCHLORIDE; MULTIVITAMINS [VITAMINS NOS],,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Body temperature', 'Confusional state', 'Dizziness', 'Hallucination', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vaccination site lymphadenopathy', 'Vomiting']",1,MODERNA,OT 1056458,NY,28.0,F,"90% of the vaccine leaked onto arm/ Did not get a full second dose; A spontaneous report was received from a Consumer concerning a 28-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 90% of the vaccine leaked onto arm/ Did not get a full second dose (incomplete dose administered). The patient's medical history was not provided. No relevant concomitant medications were reported. On 14Jan2021 the patient received first dose of the Moderna Covid-19 vaccine (2:30PM). It was administered on her left arm prophylaxis of COVID-19 infection with unknown dose and route of administration. Lot number 011L20A, unknown expiration date. On 11Feb2021, the patient had her 2nd dose of the Moderna Covid-19 vaccine (3:00PM) at a local hospital. She had it on her left arm with unknown route of administration. Lot number 0B2L20A, expiration date was unknown. During the administration of the 2nd dose, the 90% of the vaccine leaked on to her arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event was resolved on 11 Feb 2021.; Reporter's Comments: This is a case of 28-year-old female patient who was administered second dose of mRNA-1273 vaccine and experienced 90% of the vaccine leaked on to arm (incomplete dose administered) Lot #: 11L20A. There was no associated adverse event reported for the event of incomplete dose administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,02/11/2021,28.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Incorrect dose administered'],2,MODERNA,OT 1056459,NY,83.0,F,"Resident received the 1st dose of the Moderna vaccine on 05 Feb 2021. She got the second dose today.; A spontaneous report was received from a nurse concerning an 83-years-old, female patient who experienced inappropriate schedule of product administration (resident received the 1st dose of the Moderna vaccine on 05 Feb 2021. She got the second dose today.) The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 [Lot number 010M20A] on 05 Feb 2021. On 11 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 [Lot number 030M230A] intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 11 Feb2021, the patient received her 2nd dose only six days after her first dose was administered. She reports no side effects from the 1st dose. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The event resident received the 1st dose of the Moderna vaccine on 05 Feb 2021. She got the second dose today was considered recovered/resolved on 11 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #030M230A for second dose) with no associated AEs reported. Patient received second dose six days after the first dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/11/2021,6.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Inappropriate schedule of product administration'],2,MODERNA,OT 1056460,,,U,"patient was given 1ml dose in one setting instead of .5ML; A spontaneous report was received from a physician concerning a patient who experienced accidental overdose (patient was given 1ml dose in one setting instead of .5ML). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 10 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 030M30A) intramuscularly for prophylaxis of COVID-19 infection. On 10 Feb 2021, the patient was given 1 mL dose in one setting instead of .5 mL. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event patient was given 1ml dose in one setting instead of .5ML was unknown.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273. There were no reported adverse events associated with this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/10/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Accidental overdose'],1,MODERNA,OT 1056461,,,M,"Administered dose of vial that wasn't thawed as recommended; A spontaneous report was received from a consumer concerning a male patient who experienced product preparation issue (administered dose of vial that wasn't thawed as recommended). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On unknown date, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, the patient reported that the pharmacist took the vial out and injected him immediately instead of waiting 15 minutes to administer. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event administered dose of vial that wasn't thawed as recommended was unknown.; Reporter's Comments: This report refers to a case of product preparation issue for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product preparation issue'],1,MODERNA,OT 1056462,RI,,F,"headache; nausea; left the vaccine out for longer than 6 hours after the vial was punctured; A spontaneous report was received from a consumer who was a 53-year-old, female patient, who was administered Moderna's COVID-19 vaccine and the patient received first dose more than six hours after vial was punctured/expired product administered, and had headache and nausea. The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 FEB 2021, the patient received her second dose of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection. The patient's doctor told her that she received a non-effective first dose of the vaccine because the doctor left the vaccine out for longer than the six hours after the vial was punctured which was on 14 JAN 2021. The patient returned to the healthcare professional for second dose and she was informed her first dose might had been invalid/ineffective. On 11 FEB 2021, the patient experienced headache and nausea. The treatment included ondansetron as an indication for nausea on 12 FEB 2021 in the morning (am). The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event was not applicable. The outcome of event, received first dose more than six hours after vial was punctured was considered as resolved on 14 JAN 2021. The outcome of the events, headache and nausea were considered as unknown.; Reporter's Comments: This case concerns a 53-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: unknown), reporting Expired product administered. Additionally, the patient experienced headache and nausea after receiving their second of two planned doses of mRNA-1273 (Lot number: 029L20A). Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,01/14/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Expired product administered', 'Headache', 'Nausea']",2,MODERNA,OT 1056463,NE,77.0,M,"felt like crap; became hot; left hand suddenly started jerking and left hand was having spasms; Vasovagal Syncope, Post Immunization Reaction; became cold; sweaty; sore arm; achy; A spontaneous report was received from a consumer concerning a 77-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vasovagal syncope, post immunization reaction (syncope vasovagal). The patient's medical history, as provided by the reporter, included chronic cough, acid reflux, minor allergies, hypercholesterolemia and a penicillin allergy. Concomitant product use included esomeprazole, atorvastatin, famotidine, cetirizine, Montelukast, Vitamin D, zinc, fiber pills and antacids. On 10 Feb 2021, several hours prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot #:030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. After the injection in the evening on 10 Feb 2021, the patient reported experiencing a sore arm. During the night, he became cold, sweaty and achy. On 11 Feb 2021, the patient stated he ""felt like crud"" and was still achy and his left arm hurt more. The patient sat down at the table and again became ""hot"" and ""sweaty."" His left hand suddenly started jerking and having spasms, and the patient's head went back and then forward and he became unresponsive for approximately 2 to 3 minutes. After the episode, he went to a sofa chair and fell asleep for 1 to 1.5 hours. The patient's wife called a nurse at the Hospital to report the events, and the nurse suggested to take him to the emergency room (ER) immediately. At the ER, a series of tests/labs were performed including complete blood count (CBC) differential with platelets, COVID-19 test, cardiac panel-acute, comprehensive metabolic panel, electrocardiogram (EKG), and chest x-ray. All test results were normal. The patient's COVID-19 test was negative. Treatment for the event included IV fluids (sodium chloride IV). The patient was discharged from the ER 2 to 3 hours after treatment with a discharge diagnosis of ""vasovagal syncope, post immunization reaction."" The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The event, vasovagal syncope, post immunization reaction, was considered recovered/resolved.; Reporter's Comments: Based on the current available information which indicates a strong temporal association between the use of the product and the onset of the reported events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/10/2021,0.0,UNK,ESOMEPRAZOLE; ATORVASTATIN; FAMOTIDINE; CETIRIZINE; MONTELUKAST; VITAMIN D NOS; ZINC; METHYLCELLULOSE,Acid reflux (esophageal); Allergy multiple; Chronic cough; Hypercholesterolemia; Penicillin allergy,,,,"['Chest X-ray', 'Electrocardiogram', 'Feeling cold', 'Feeling hot', 'Full blood count', 'Hyperhidrosis', 'Malaise', 'Metabolic function test', 'Muscle spasms', 'Myalgia', 'Myocardial necrosis marker', 'SARS-CoV-2 test', 'Syncope', 'Vaccination site pain']",2,MODERNA,OT 1056464,TX,,U,"pulled the syringe to early that the complete dose could not be injected in the patient body; it spilled off from the needle and on the patient's arm; A spontaneous report was received from a Healthcare Professional, concerning a patient of unknown age, who was administered Moderna's COVID-19 vaccine and the reporter noticed that one of their nurse pulled the syringe to early that the complete dose could not be injected in the patient body and it spilled off from the needle and on the patient's arm/ underdose. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their second dose of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection. The reporter noticed that one of their nurse while administering the vaccine to a patient that she pulled the syringe to early that the complete dose could not be injected in the patient body and it spilled off from the needle and on the patient's arm on an unknown date. The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event was not applicable. The outcome of event, pulled the syringe to early that the complete dose could not be injected in the patient body and it spilled off from the needle and on the patient's arm was considered as resolved.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273, lot # 041L20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Exposure via skin contact', 'Underdose']",2,MODERNA,OT 1056465,FL,,F,"Second dose was Pfizer's; A spontaneous report was received from a consumer concerning a female patient, of 85-year-old, who was administered Moderna's COVID-19 vaccine and second dose was Pfizer's/wrong product administered. The patient's medical history not reported. Products known to have been used by the patient, within two weeks prior to the event, included were acetylsalicylic acid, lisinopril, centrum vitamins, linagliptin and furosemide sodium from an unknown date for an unknown indication. On 06 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in the right arm for prophylaxis of COVID-19 infection. On 22 JAN 2021, the patient was given second dose of Pfizer's vaccine. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was unknown. The outcome of event, second dose was Pfizer's was considered as resolved on 22 JAN 2021.; Reporter's Comments: This is a case of 85-year-old female patient who was administered mRNA-1273 vaccine and second dose was Pfizer's (wrong product administered) Lot number: unknown. There was no associated adverse event reported for the event of wrong product administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/22/2021,16.0,UNK,ASPIRIN [ACETYLSALICYLIC ACID]; LISINOPRIL; CENTRUM VITAMINTS; TRADJENTA; FUROSEMIDE [FUROSEMIDE SODIUM],,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Wrong product administered'],1,MODERNA,OT 1056466,,,F,"Anaphylactic reaction; Redness; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed redness and anaphylactic reaction. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient developed redness and anaphylactic reaction. She took ibuprofen post vaccination and diphenhydramine for the anaphylactic reaction. Her physician assistant also ordered epinephrine. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, redness and anaphylactic reaction, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Anaphylactic reaction', 'Erythema']",1,MODERNA,OT 1056467,TX,34.0,M,"lost 70-80% of sight; dizzy; ringing in ear; all sounds were coming down a tunnel; A spontaneous report was received from a consumer concerning a 34-year-old old, male patient who experienced 70-80% blindness, dizziness, and ringing in his ear. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 10FEB2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient got first dose of Moderna vaccine on 10FEB2021 in left non dominant arm. Patient notes he has always had a reaction to anything external going in his body. After receiving vaccine, he felt fine for about 5 seconds then felt dizzy, lost 70-80% of sight and had ringing in his ear. Patient said all sounds were coming down a tunnel. Patient asked for a place to lie down and symptoms resolved about 2 minutes later. Patient wants to know if it is safe to get second dose. Also wants to know if he can change vaccination facility for second dose. Treatment information was not provided/unknown. The events resolved on same day.; Reporter's Comments: This case concerns a 34 year old, male patient, who experienced a serious unexpected event of blindness transient, among other non-serious events, after receiving first dose mRNA-1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Blindness transient', 'Dizziness', 'Dysacusis', 'Tinnitus']",1,MODERNA,OT 1056468,MO,16.0,F,"Received the COVID vaccine at age 16; Injecstion site pain; A spontaneous report was received from a physician regarding his daughter who is a 17-year-old female, unknown race and ethnicity, who was administered Moderna Covid-19 vaccine and experienced pain at injection site. The patient's medical history was not provided. No concomitant medications were reported. No information on allergies. On 22-Jan-2021, prior to the onset of events, patient received her first of two planned doses of Moderna Covid-19 vaccine intramuscularly for the prophylaxis of Covid-19 infection. (Lot#011J20A). The physician who is patient's father would like to give her the second dose. Also, he wanted to consider her for pediatric trials. Action taken with vaccine is physician showed willingness to give his daughter a second dose. The outcome of the events, inappropriate age at vaccination and pain at injection site is unknown at the time of report.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (Lot # 011J20A) with pain at injection site reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Injection site pain', 'Product administered to patient of inappropriate age']",1,MODERNA,OT 1056469,TX,88.0,U,"Rapid heart beat; spinning intermittent; off balance leaning left; slow to breath; Appetite; Weakness; Fatigue; Blackout; Nausea; Dizzy/ room spinning; A spontaneous report was received from a consumer ( concerning an 88-year-old, patient of unknown gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blackout, dizziness, nausea, fatigue, room spinning counter clockwise, loss of appetite, weakness, rapid heartbeat, spinning intermittent, off balance leaning left and slow breath. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 3FEB2021, approximately 2 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:013ML0A) intramuscularly for prophylaxis of COVID-19 infection. On 5 Feb2021,the patient became dizzy. On 6 Feb 2021, the patient experienced blackout and nausea.. On 7 Feb 2021, the patient experienced fatigue. The next day, on 8 Feb 2021,the patient had loss of appetite and weakness .On 10 Feb 2021, the patient had rapid heartbeat, spinning intermittent, off balance leaning left and slow to breath. Treatment information was not provided. The outcome of the events was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported events, a causal relationship cannot be excluded. Nausea and fatigue are consistent with the known safety profile of mRNA-1273.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/05/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Appetite disorder', 'Asthenia', 'Balance disorder', 'Dizziness', 'Fatigue', 'Heart rate increased', 'Loss of consciousness', 'Nausea', 'Respiratory rate decreased', 'Vertigo']",1,MODERNA,OT 1056470,FL,91.0,F,"Blood Pressure did not decrease significantly post medication; Blood Pressure increased to 224; Pain (Grade 8 out of 10) under breast line, chest and across the back shoulder blades; Intestine blockage; Constipation Continued (Initiated 3 days prior to Vaccination); A spontaneous report was received from a consumer concerning a 91-year-old, female patient who developed Pain (Grade 8 out of 10) under breast line, chest and across the back shoulder blades, Constipation Continued (Initiated 3 days prior to Vaccination), Blood Pressure increased to 224, Blood Pressure Did not decrease significantly post medication, Intestine blockage, and Reduced Pain (Grade 4 out of 10 now) post Bowel Movement. The patient's medical history included constipation. Concomitant product use was not provided by the reporter. On 28JAN2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:031L20A) intramuscularly in the upper arm for prophylaxis of COVID-19 infection. On 28JAN2021 patient received the first dose of Moderna COVID-19 vaccine. For three days prior to vaccination patient was constipated and did not have a Bowel Movement at all. After the vaccination patient had pain (Grade 8 out of 10) under breast line, chest and across the back-shoulder blades. The evening of 28JAN2021 she visited the Emergency Room because of the pain. ER nurse reported patient Blood Pressure went up to 224 and was very high. Patient was treated with BP medication, but BP did not change significantly. This led to patient being admitted to the hospital at for overnight for observations. All tests were negative. She was diagnosed as ""Intestines were blocked"". She was released on 29JAN2021. She had a BM 6 days later on 03FEB2021. The pain is better (Grade 4 out of 10 now). The outcome of the events was unknown; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/28/2021,01/25/2021,,UNK,,Constipation,,,,"['Blood pressure inadequately controlled', 'Blood pressure increased', 'Constipation', 'Intestinal obstruction', 'Pain']",1,MODERNA,OT 1056471,WI,,F,"she did go to anaphylactic shock; A spontaneous report was received from a consumer concerning a 38-year-old female patient who experienced immediate anaphylactic shock (she did go to anaphylactic shock). The patient's medical history was not provided. No relevant concomitant medications were reported. On 13-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection. The reporter stated that her daughter had an immediate anaphylactic shock after receiving the vaccine on 13-JAN-2021 in another state. The reporter's daughter was treated with EpiPen (epinephrine) x 2 and then was transferred to an emergency room (ER) by ambulance where she was observed all day. She reports that her daughter is not allowed to get the second shot. The second dose of mRNA-1273 was discontinued in response to the event. The outcome of the event was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Yes,Not Reported,,Not Reported,U,01/13/2021,01/13/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Anaphylactic shock'],1,MODERNA,OT 1056472,TX,16.0,U,"16 year old received 1th shot of Moderna vaccine; A spontaneous report was received from a healthcare provider concerning a 16-year-old patient of unknown gender who received the vaccine. The patient's medical history included Sickle Cell Disease. Concomitant product use was not provided by the reporter. On 10FEB2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. HCP reporting 16-year-old patient with Sickle Cell Disease has received 1st shot of Moderna vaccine on 10Feb2021. HCP is asking if the patient should receive 2nd Moderna shot. The event, vaccine at inappropriate age (16 years old), was recovered/resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,UNK,,Sickle cell disease,,,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1056473,NY,92.0,M,"AFib; Jaw and tooth pain; Jaw and tooth pain; Rapid heartbeat/Rapid pulse; Extreme weakness; Irregular heartbeat; blood pressure was 142/80; A spontaneous report was received from a consumer concerning a 92-years-old, male patient who experienced AFib (atrial fibrillation), rapid heartbeat/rapid pulse, extreme weakness, irregular heartbeat, blood pressure was 142/80, jaw and tooth pain. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine sodium, metoprolol tartrate, pravastatin, fexofenadine, vitamin D, acetylsalicylic acid, fluticasone propionate and latanoprost. On 04 Feb 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 004M20A] intramuscularly in the for prophylaxis of COVID-19 infection. On 04 Feb 2021, the patient woke up that night with jaw and tooth pain. He later experienced rapid heartbeat, extreme weakness, irregular heartbeat, rapid pulse and AFib (atrial fibrillation) which was confirmed by his primary care physician (PCP) on 06 Feb 2021. On 08 Feb 2021, patient repoted his blood pressure was 142/80. Treatment for the event included metoprolol IV. Action taken with mRNA-1273 in response to the events was not provided. The events rapid heartbeat/rapid pulse and extreme weakness were considered recovered/resolved or on 08 Feb 2021 and the outcome of the events AFib (atrial fibrillation), irregular heartbeat, blood pressure was 142/80, jaw and tooth pain were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/06/2021,2.0,UNK,SYNTHROID; METOPROLOL TARTRATE; PRAVASTATIN; FEXOFENADINE; VITAMIN D [VITAMIN D NOS]; BABY ASPIRIN; FLONASE [FLUTICASONE PROPIONATE]; LATANOPROST,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Asthenia', 'Atrial fibrillation', 'Heart rate increased', 'Heart rate irregular', 'Hypertension', 'Myocardial necrosis marker', 'Pain in jaw', 'Toothache']",1,MODERNA,OT 1056474,CA,,F,"Blood and fluid that leaked out on to arm; Did not get the full dose; A spontaneous report was received from a consumer concerning a 59--year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced when the needle was pulled out she felt that there was blood and fluid that leaked out on to her arm and she thinks she did not get the full dose. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (BATCH # 029L20A) on 15 Jan 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient received their second of two planned doses of mRNA-1273 (BATCH # 006M20A) on 12 Feb 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection. Reporter stated that she had her second dose of the Modera COVID-19 vaccine 12 Feb 2021, at a drive in vaccination clinic. She had it on her left arm. When the needle was pulled out, she felt that there was blood and fluid that leaked out on to her arm and she thinks that she did not get the full dose. Lot number 006M20A, expiration date unknown. The first dose was administered through the same site on 15 Jan 2021 on her left arm with unknown dose and route of administration. Lot number 029L20A, unknown expiration date. Reporter wanted to know what the protocol was for vaccine leakages, if she should get another dose and if she got the full protection from the vaccine. No further information was reported. No treatment information was provided. Action taken with RNA-1273 in response to the event was unknown. The outcome of the events was unknown.; Reporter's Comments: This is a case of 59--year-old, female patient who was administered mRNA-1273 and experienced when the needle was pulled out she felt that there was blood and fluid that leaked (Injection site leaking ) out on to her arm and she thinks she did not get the full dose ( incomplete dose administered) batch # 006M20A. There was no associated adverse event reported for the events of injection site leaking and incomplete dose administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,02/12/2021,28.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Incorrect dose administered', 'Injection site extravasation']",2,MODERNA,OT 1056475,GA,79.0,M,"Lung cancer; A spontaneous report was received from a consumer concerning a 79-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced lung cancer. The patient's medical history was not provided. No relevant concomitant medications were reported. On 09 Feb 2021, approximately 0 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 09 Feb 2021, the patient tested positive for lung cancer. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event lung cancer was unknown.; Reporter's Comments: Based on the current available information and the very short duration of onset between the use of the product and the start date of lung cancer, a causal relationship is unlikely. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,02/09/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Lung neoplasm malignant'],1,MODERNA,OT 1056476,WV,73.0,M,"Seizures; Mini stroke; Tired; A spontaneous report was received from a consumer concerning a 73-year-old male who received Moderna Covid-19 vaccine and experienced seizures, mini stroke, confused, agitated, eyes were abnormal, memory impairment, and tired. The patient's medical history included heart attack and stent placement in 2011. His relevant concomitant medications include acetylsalicylic acid, candesartan cilexetil, clopidogrel bisulfate, diltiazem hydrochloride, ezetimibe, adenosine, gabapentin, metoprolol tartrate and rosuvastatin calcium. The patient received their first of two planned doses of mRNA-1273 on 14 Jan 2021. On 10 Feb 2021, 30 minutes prior to the onset of the events, the patient received his second of two planned doses of mRNA-1273 (Lot#010M20A) intramuscularly in left deltoid for the prophylaxis of COVID-19 infection. On 10 Feb 2021, With in 30 minutes of receiving the vaccination, the patient had a seizure. They took him to the hospital, where he had a computerized tomography (CT) scan, blood work and had a consult. After consult, they said, it's a mini stroke. They released him and told her if it happens again call 911. He felt so tired and went to sleep at home. Around 17:00 dinner time, he woke up looked very blankly, and his wife reported knowing he had another seizure. She reported he ran to his keys saying, ""I have to go"", seemed confused, agitated and didn't know where he was. She called 911 andhe was transported to the hospital in an ambulance. Around 19:00 the same day, he was admitted to do scans overnight. Around 21:00, patient's eyes were abnormal, he became agitated again and nurses confirmed he was having another seizure. 30 minutes later, he was talking to his wife and daughter as if he didn't remember anything. He mentioned some metallic taste in his mouth. On 11 Feb 2021, they did an electroencephalogram (EEG) and confirmed that he was having seizure. He was prescribed seizure medication and released him from hospital. However, the patient and his wife reported not wanting him to take the medication as they believe the events were due to the vaccine. Treatment information was not provided. Action taken with vaccine is not applicable as the patient received both the doses. The outcomes of the events, seizures, mini stroke, and tired, were recovered.; Reporter's Comments: Very limited information regarding this event has been provided at this time. The patient's medical history of heart attack and concomitant medication use can be confounding factor. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/14/2021,02/10/2021,27.0,UNK,BABY ASPIRIN; ATACAND; PLAVIX; CARDIZEM CD; ZETIA; TRICOR [ADENOSINE]; NEURONTIN; LOPRESSOR; CRESTOR,,Medical History/Concurrent Conditions: Heart attack (Heart attack in 2011 and stent was placed.); Stent placement,,,"['Cerebrovascular accident', 'Electroencephalogram', 'Fatigue', 'Seizure']",1,MODERNA,OT 1056477,OR,,F,"Saw a lot of blood on the water when she was taking a shower; arthritis act up; dizzy; A spontaneous report was received from a 76-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and felt dizzy, arthritis come up, and saw a lot of blood on the water when she was taking a shower. The patient's medical history included arthritis. No relevant concomitant medications were reported. On 09 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 09 Feb 2021, the patient felt dizzy after receiving the Moderna vaccine. On 10 Feb, 2021 the patient reported that her arthritis had come up and she took two aspirins. The patient reported blood on the water while she was taking a shower. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported event of dizziness and arthritis, a causal relationship cannot be excluded. Although a temporal association exist, there is still not enough information to assess the causal association between the event saw blood and mRNA-1273 . Critical details such as the source of blood patient's medical history is lacking. Further information has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,02/09/2021,0.0,UNK,,Arthritis,,,,"['Arthritis', 'Dizziness', 'Haemorrhage']",1,MODERNA,OT 1056478,MI,48.0,M,"Second dose was taken 14 days after 1st dose; Headache; Body aches; A spontaneous report received from a consumer concerning a 48-year-old male patient who received the second dose of Moderna COVID-19 vaccine and second dose was taken 14 days after 1st dose and experienced headache, and body aches. The patient's medical history was not included/ unknown. Patient's concomitant was not included/ unknown. Patient received 1st vaccine on 29 JAN 2021 (Lot number 029L20A) and had no symptoms. On 11-FEB-2021, the patient received the second of two planned doses of mRNA-1273 (Batch #: 013M20A) intramuscularly for prophylaxis of COVID-19 infection. Patient received the second vaccine on 11 FEB 2021 and reported the development of headache, and body aches. Patient stated having been told by his employer that he needed to take the second dose. Patient realized after receiving the second vaccination that maybe he took the second dose too early. Second dose was taken 14 days after 1st dose. Treatment for events included naproxen . Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event headache, and body aches, were unknown at the time of this report. The outcome of event second dose was taken 14 days after 1st does and experienced was considered resolved on 11 FEB 2021.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot #029L20A, with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,02/11/2021,13.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Headache', 'Inappropriate schedule of product administration', 'Myalgia']",2,MODERNA,OT 1056479,CA,34.0,F,"During vaccination, needle came loose and 50% of the vaccine was spilled; During vaccination, needle came loose and 50% of the vaccine was spilled; A spontaneous report was received from a physician's assistant concerning a 34-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and during vaccination, needle came loose (device connection issue) and 50% of the vaccine was spilled (underdose). The patient's medical history was not provided. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (batch number not provided) on an unknown date. On 11 Feb 2021, on the same day as the onset of events, the patient received their second of two planned doses of mRNA-1273 (batch number: 038K20A) in the left arm for prophylaxis of COVID-19 infection. On 11 Feb 2021, during vaccination, the needle came loose and 50% of the vaccine was spilled. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, the action taken with the drug in response to the events was not applicable. The outcome of the events, during vaccination, needle came loose and 50% of the vaccine was spilled, was considered recovered/resolved on 11 Feb 2021.; Reporter's Comments: This report refers to a case of Underdose due to loose needle for mRNA-1273, lot # 038K20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Needle issue', 'Underdose']",1,MODERNA,OT 1056480,NC,,F,"Itchy eyes; Redness on the face; Rash just below her neck and above her chest; blotchiness but no hives; Readministered the vaccine to the patient thinking the first vial was empty; A spontaneous report received from a consumer concerning a 66-year-old female patient who received the first dose of Moderna COVID-19 vaccine and where the patient felt the needle go in but didn't feel the liquid and had developed itchy eyes, redness on the face, rash just below her neck and above her chest, and was readministered the vaccine to the patient thinking the first vial was empty. The patient's medical history was not provided. Patient's concomitant was not provided. On 12-FEB-2021, the patient received their first of two planned doses of mRNA-1273 in her right arm (Batch #: 024M20A) intramuscularly for prophylaxis of COVID-19 infection. On 12Feb2021 patient experienced itchy eyes, redness on the face, and a rash just below her neck and above her chest. There was ""blotchiness but no hives"". She had the same type of reaction as she does to orange peels. She had no trouble breathing. She took some diphenhydramine hydrochloride to help. The nurse also re-administered the vaccine to the patient thinking the first vial was empty and as the patient felt the needle go in but didn't feel the liquid. Action taken with mRNA-1273 in response to the events were not provided. The outcome of events itchy eyes, redness on the face, rash just below her neck and above her chest were unknown at the time of this report. The outcome of events the patient felt the needle go in but didn't feel the liquid was considered resolved on 12-Feb-2021 and readministered the vaccine to the patient thinking the first vial was empty were considered resolved on an unspecified date in Feb-2021.; Reporter's Comments: This case concerns a 66 year old, female patient, who experienced a non-serious unexpected event of eye pruritus, erythema, rash macular, after receiving first dose mRNA-1273. This report refers to a case of overdose for mRNA-1273 (lot # 024M20A), with no associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Erythema', 'Eye pruritus', 'Overdose', 'Rash macular']",1,MODERNA,OT 1056481,HI,,F,"Bell's Palsy; A spontaneous report received from a Healthcare Professional concerning, 81-year-old female patient who received the first dose of Moderna COVID-19 vaccine and was hospitalized for Bell's Palsy. The patient's medical history was not included/ unknown. There were no concomitant medications provided. On 15-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Patient was hospitalized on 19Jan2021 because developed Bell's palsy. Patient was observed because it was thought that she had a stroke. It was not a stroke. On 22Jan2021 the patient left the hospital. Second dose of Moderna COVID-19 vaccine is scheduled on 12Feb2021. Reporter wanted to know if patient should get second dose of Moderna COVID-19 vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/15/2021,01/19/2021,4.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Facial paralysis'],1,MODERNA,OT 1056482,FL,74.0,F,"Severe flu symptoms; feeling incapacitated; Gagging; Feeling like humming and buzzing (motor-like); Throat constriction/contraction; Eye/vision distorted and were constricted; Felt like head would explode; forehead and headache; Forehead/head constriction; Constriction/contraction of chest; A spontaneous report was received from a consumer, a 74-year-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced, feeling like humming and buzzing (motor-like), throat constriction/contraction, eye/vision distorted and were constricted, felt like head would explode, forehead/head constriction, constriction/contraction of chest, severe flu symptoms, feeling incapacitated, and gagging. The patient's medical history was not reported. No concomitant medications were reported. On 10 Feb 2021, prior to the onset of events, the patient received their second planned doses of mRNA-1273 (batch number: 030M20A), intramuscular for the prophylaxis of COVID-19 infection. The patient reported that she had adverse reactions after administering the vaccine around 2:00 on 10 Feb 2021. Later, the patient went to bed. On 11 Feb 2021, at midnight, the patient started feeling like that she was humming and buzzing from the waist up; throat was constricted and contracted; gagged a few times; vision/eyes were constricted and vision was distorted; forehead, and head ache felt constricted and felt like it was going to take off and was so tight. Later, it moved to chest, the constriction/contraction was so tight that and felt like someone was standing on it. The patient stated that these feelings were all above the waist and lasted for about an hour and ten minutes and just stopped on the same day. The next day on 12 Feb 2021, about six hours later, the patient had regular side effects which started about 10 hours after the shot. The patient was fine for about six hours then had severe flu symptoms and was feeling just incapacitated. The patient just got rid of these flu symptoms around 1 pm on the same day. The patient wanted to know if these were allergy symptoms. No treatment medication information was provided Action taken with second dose of mRNA-1273 in response to the events was not applicable. The outcome of the events, feeling like humming and buzzing (motor-like), throat constriction/contraction, eye/vision distorted and were constricted, felt like head would explode, forehead/head constriction, constriction/contraction of chest, and gagging were recovered on 11 Feb 2021 and that of event severe flu symptoms was recovered on 12 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Yes,Y,02/10/2021,02/11/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Asthenia', 'Breath sounds abnormal', 'Chest discomfort', 'Choking', 'Headache', 'Influenza like illness', 'Metamorphopsia', 'Tension headache', 'Throat tightness']",2,MODERNA,OT 1056483,,,F,"cardiomyopathy; A spontaneous report received from a Healthcare Professional concerning, 72-year-old female patient who received the second dose of Moderna COVID-19 vaccine and develop cardiomyopathy. The patient's medical history was not included. Patient's concomitant was not included. On 01-FEB-2021, the patient received their second of two planned doses of mRNA-1273 (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Physician called and stated that his wife received the second Moderna COVID-19 vaccination on 01-FEB-2021 and on 05-FEB-2021 she developed cardiomyopathy. He stated that he would like for someone in the medical department to call him back. Treatment information was not provided/ unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was unknown/not reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/05/2021,4.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,['Cardiomyopathy'],2,MODERNA,OT 1056484,FL,63.0,F,"Very dizzy; Threw up; Episode of afib; Light headache; A spontaneous report was received from a consumer (patient), 63 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced, episode of A-fib (atrial fibrillation), very dizzy (dizziness), threw up (vomiting), and light headache (headache). The patient's medical history included episode of A-fib. Current conditions included diabetic and high blood pressure. No concomitant medications were reported. On 03 FEB 2021, seven days prior to the onset of events, the patient received their first of planned doses of mRNA-1273 (batch number: 038K20A), intramuscular in the left arm for the prophylaxis of COVID-19 infection. It was reported that two days ago, the patient had an episode of atrial fibrillation on 10 FEB 2021. The patient doesn't know if it was from the vaccine or something else. The patient usually has 2-3 times of atrial fibrillation a year. She didn't have any other side effects at all right after the vaccine. The patient was a diabetic and didn't call her doctor about this, because it went away. The patient described the atrial fibrillation episode as uncomfortableness and beating of the heart. The patient has an appointment with her cardiologist 2 days before her second shot, and she'd ask him about it. The patient was also wondering that the side effects occurred 8 or 9 days after the shot. She has high blood pressure and took a measurement, and it was normal at 93 (unknown units). The patient had the injection on her left arm because she has a diabetic monitor on right arm. The patient didn't take any treatment for the side effect except one time she took acetaminophen about three days ago when she had a light headache. On 12 FEB 2021, at about 10 am in the morning, the patient got very dizzy and had to sit down on the floor, and she threw up. After that, the patient was feeling fine. The patient gave consent to follow up from safety and to her doctor. No further treatment medications were reported. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of the events, episode of A-fib, and light headache were unknown and that of events very dizzy, and vomiting was recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient's medical history of having 2-3 times of atrial fibrillation a year, diabetic and high blood pressure are the risk factors and confounds to the causality.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/01/2021,,UNK,,AFib (2-3 times of Afib a year); Blood pressure high; Diabetic,,,,"['Atrial fibrillation', 'Blood pressure measurement', 'Dizziness', 'Headache', 'Vomiting']",1,MODERNA,OT 1056485,,,U,"Patient received less than half the dose; the needle and syringe detached; A spontaneous report received from a physician concerning a patient of unknown age and gender, who received dose of Moderna COVID-19 vaccine and think they received half the dose (incorrect dose administered) and the needle and syringe detached (device connection issue). The patient's medical history was not included. Patient's concomitant was not included. On unknown date, the patient received their unknown of two planned doses of mRNA-1273 unknown arm (Batch #: unkown) intramuscularly for prophylaxis of COVID-19 infection. Physician stated that the needle and syringe detached, and they think the patient received less than half the dose. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the events was resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Device connection issue', 'Incorrect dose administered']",1,MODERNA,OT 1056486,FL,88.0,M,"felt delirious; felt lightheaded; had a terrible dream; felt nauseous; A spontaneous report was received from a consumer reporting on himself, an 88-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt delirious/MedDRA PT: delirious, felt nauseous/MedDRA PT: nausea, felt lightheaded/MedDRA PT: lightheadedness, and had a terrible dream/MedDRA PT: terrifying dreams. The patient's medical history was not provided. Concomitant medication use was not provided. On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. The patient reported that during the night, he felt lightheaded, had a terrible dream, felt nauseous and delirious. The patient felt better the following day and his primary care physician was aware of the side effects. Treatment for the events included paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events of felt delirious, felt nauseous, felt lightheaded and had a terrible dream were considered recovering/resolving.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the event to be unlikely related to company product.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Delirium', 'Dizziness', 'Nausea', 'Nightmare']",2,MODERNA,OT 1056487,,,F,"17 year old received the 1st dose of the vaccine; A spontaneous report was received from a pharmacist concerning a 17-year-old, patient who received the first dose of Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, it was reported that a 17-year-old received the first dose of the vaccine. No treatment information was reported. Action taken with mRNA-1273 in response to the event was not reported The outcome of the event, 17-year-old patient received the 1st dose of the vaccine, was resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1056488,MA,70.0,F,"Administered the vaccine below the deltoid or at the end of the deltoid; Symptoms are as if got the flu shot; Warm; Hard; Tired; Red area on arm the size of a quarter; Headache; A spontaneous report was received from a nurse who is a 70-year-old, white female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced administered vaccine below the deltoid or at the bottom of the deltoid/incorrect route of product administration, tired/fatigue, headache, red area on arm the size of a quarter/injection site erythema, warm/injection site warmth and hard/injection site induration, and symptoms are as if got the flu shot/influenza like illness. The patient's medical history was not provided. No concomitant medications were reported. On 11 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) in the right arm intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient reported, the Moderna COVID-19 vaccine was administered below the deltoid or at the end of the deltoid. The patient also reported she was tired and had a headache and there was a red, warm and hard area the size of a quarter on her arm. She stated, her symptoms were like that of when she received the flu vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, administered vaccine below the deltoid or at the bottom of the deltoid/incorrect route of product administration, was considered resolved on 11 Feb 2021. The outcome of the events, tired/fatigue, headache, red area on arm the size of a quarter/injection site erythema, warm/injection site warmth and hard/injection site induration, and symptoms are as if got the flu shot/influenza like illness, were considered unknown.; Reporter's Comments: This is a case of 70--year-old, female patient who was administered mRNA-1273 and experienced below the deltoid or at the bottom of the deltoid (vaccine administered at inappropriate site) Lot # BATCH # 026L20A. The other events temporarily association with product and a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,01/11/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Fatigue', 'Headache', 'Influenza like illness', 'Product administered at inappropriate site', 'Vaccination site erythema', 'Vaccination site induration', 'Vaccination site warmth']",2,MODERNA,OT 1056489,CA,72.0,F,"I can't move my arm/can't bring my arm up to my breast and obviously over my head/this really limits my mobility; it was that upper joint area that was throbbing; couldn't sleep much because it was excruciating; extreme pain in my shoulder/excruciating pain in my shoulder/that top part, that ball and socket was excruciating to move; Vaccine given too high up in my arm/it felt like it was going into my bone at the top; Chills; my whole arm hurt/it's excruciating when I attempt to be mobile; A spontaneous report was received from a consumer (United States) concerning herself, a 72-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273), who experienced the following events: I'm concerned it was given too high up in my arm/it felt like it was going into m y bone at the top/MedDRA PT: inappropriate route of vaccination, that top part, that ball and socket was excruciating to move/MedDRA PT: joint pain, I can't move my arm/can't bring my arm up to my breast and obviously over my head/this really limits my mobility/MedDRA PT: injected limb mobility decreased, chills, my whole arm hurt/it's excruciating when I attempt to be mobile/MedDRA PT: pain in arm, couldn't sleep much because it was excruciating/MedDRA PT: sleep difficult, it was that upper joint area that was throbbing/MedDRA PT: throbbing pain, band ack to the same pain I had after the injection/MedDRA PT: shoulder pain. The patient's medical history included cancer and child birth x 2. Concomitant medication use was not provided. On 03 Feb 2021, the patient received the first of two planned doses of mRNA-1273 ([LOT 029L20A]) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Action taken with mRNA-1273 in response to the events was not reported. The even of ""a couple of patients received their dose at 7 hours"" was considered recovered/resolved (date unspecified).; Reporter's Comments: This case concerns a 72-year-old female who had NS unexpected Incorrect route of product administration and NS unexpected injected limb mobility decreased, painful arm, throbbing pain, insomnia and NS expected arthralgia, chills. The events occurred the same day as first dose of mRNA-1273. Treated with Tylenol. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Cancer; Live birth (had 2 children.),,,"['Arthralgia', 'Chills', 'Incorrect route of product administration', 'Injected limb mobility decreased', 'Insomnia', 'Pain', 'Pain in extremity']",1,MODERNA,OT 1056490,GA,32.0,F,"punctured vial was left out at room temp and opened for more than 6 hours; A spontaneous report was received from a healthcare provider concerning a 32-year-old, female patient who received a vaccine at her work place when the punctured vial was left out at room temperature and opened for more than 6 hours (expired product administered). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A ) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient received a vaccine at her work place when the punctured vial was left out at room temperature and opened for more than 6 hours. Treatment information was not provided. The event was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # 026L20A) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Expired product administered'],1,MODERNA,OT 1056491,,,F,"Received first dose of Moderna and second dose was Pfizer; A spontaneous report was received from a consumer who is a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received first dose of Moderna and second dose was Pfizer/wrong product administered The patient's medical history was not provided. No concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient reported her first dose of the vaccine was from Moderna and her second dose was from Pfizer. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event, received first dose of Moderna and second dose was Pfizer/wrong product administered, was considered resolved.; Reporter's Comments: This report refers to a case of wrong product administered with second dose with Pfizer vaccine and with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Wrong product administered'],1,MODERNA,OT 1056492,CA,,U,"patient was administered a dose of the vaccine from punctured vial that was punctured for more; A spontaneous report was received from a pharmacist concerning a patient who experienced patient had been administered a dose from a punctured vial that had been punctured for more than hours. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the event(s) was not reported.; Reporter's Comments: This case concerns a patient of unknown age and gender who experienced nonserious unexpected event of Expired product administered with mRNA-1273 (Lot # unknown), with no associated adverse events. Reporter stated that patient was given ""vaccine from a punctured vial that had been punctured for more than hours"". The event occurred the same day as the first dose of mRNA-1273. Very limited information has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Expired product administered'],1,MODERNA,OT 1056493,OK,16.0,F,"Injection site pain and tenderness; 16 year old patient administered the vaccine; A spontaneous report was received from a health care provider regarding a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) inappropriately at the age of 16 and experienced injection site pain and tenderness/vaccination site pain. The patient's medical history was not included. Products known to have been used by the patient were Vitamin D3 and ethinylestradiol, ferrous fumarate, norethisterone. On 12 Feb 2021, prior to the onset of the events, the patient inappropriately received the first of two doses of mRNA-1273 (Lot number: 031M20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. On 13 Feb 2021, the day after the vaccine was given the patient experienced injection site pain and tenderness. Treatment information was not provided. Action taken with mRNA-1273 was not reported. The outcome of the events, vaccine being given inappropriately to a 16-year-old, was considered resolved on 12 Feb 2021. The event, vaccine site pain and tenderness, was unknown.; Reporter's Comments: This case concerns a 16-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 031M20A), reporting Product administered to patient of inappropriate age with associated adverse event of vaccination site pain. Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,UNK,VITAMIN D3; NOTREL 7/7/7,,Medical History/Concurrent Conditions: No adverse event (Medical history not provided),,,"['Product administered to patient of inappropriate age', 'Vaccination site pain']",1,MODERNA,OT 1056494,CA,,M,"vaccine was coming out of the syringe and needle; seems that patient did not have the full dose; vaccine came out of syringe running down the patients arm; A spontaneous report was received from a Pharmacist regarding a male patient who received first dose of Moderna Covid-19 vaccine and vaccine came out of syringe (device connection issue) running down the patients arm (exposure via skin contact). It seems that patient did not receive the full dose (underdose). The patient's medical history was not provided. No concomitant medications were provided. No information on allergies. On 13-FEB-2021, prior to the onset of events, the patient received first of two planned doses of Covid-19 vaccine for the prophylaxis of Covid-19 infection. According to Pharmacist, while administering the vaccine using 25G pharmacy needle, as soon as he pushed down the plunger, vaccine came out of syringe and needle running down the patients arm. Patient didn't seem to get the full dose and he is a lean guy, did not feel anything during administration. Pharmacist was enquiring with Medical information center at Moderna whether it is safe to give another dose. He was informed that in case of deviation from recommended dose, dose should not be repeated, and the patient should be closely followed for safety outcomes. Action taken with the 2nd dose of vaccine was not reported. The events, vaccine came out of syringe running down the patients arm and seems that patient did not receive the full dose, were resolved on 13 Feb 2021.; Reporter's Comments: This case concerns a 68-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: unknown), reporting device connection issue, underdose and exposure via skin contact without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,02/13/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Device connection issue', 'Exposure via skin contact', 'Underdose']",1,MODERNA,OT 1056495,SC,82.0,M,"angina; a stomachache that lasted for 10 hours; nausea; vomited 1 time; A spontaneous report was received from a consumer concerning an 82-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angina (angina pectoris), stomachache (abdominal pain upper), nausea and vomiting 1 time. The patient's medical history included 3 stents in the heart and angina. Concomitant product use was not reported. On 03 Feb 2021, approximately 26 hours prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number unknown) in the left arm for prophylaxis of COVID-19 infection. The reporter stated that 26 hours after receiving the vaccine, he had a stomachache that lasted for 10 hours. The patient also experienced nausea and vomited 1 time. Early in the week of 08 Feb 2021, the patient reported experiencing angina, which he stated he had not had for a very long time. The patient reported that no treatment medications were taken for these side effects. The patient stated that he will follow up with his cardiologist. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, angina, was unknown. The events, stomachache, nausea, and vomiting, were considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of abdominal pain, nausea and vomitting, a causal relationship cannot be excluded. The patient's medical history of 3 stents in the heart and angina confounds to the causality of Angina Pectoris.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/04/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Anginal discomfort; Stent placement (He has 3 stents in his heart),,,"['Abdominal pain upper', 'Angina pectoris', 'Nausea', 'Vomiting']",1,MODERNA,OT 1056496,FL,,F,"Hospitalized; A regulatory report was received from a consumer concerning a female patient who experienced hospitalization. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. The patient received her first of two planned doses of mRNA-1273 Batch number not provided on 11-JAN-2021 for prophylaxis of COVID-19 infection. The patient received the first dose of the Moderna COVID-19 vaccine on 11Jan2021. On 07Feb2021 she was hospitalized for reasons she didn't want to specify and returned home on 11Feb2021. She missed her appointment for her second dose on 08Feb2021because of the hospitalization. She didn't want a callback because she says that this was not related to the vaccine, so no further information was gathered. Treatment information was not provided/unknown. The second dose of mRNA-1273 was temporarily withheld in response to the event. The event of hospitalization was considered recovered/resolved on 11 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/11/2021,02/07/2021,27.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,['Hospitalisation'],1,MODERNA,OT 1056497,,22.0,F,"Severe anaphylaxis allergic reaction; Passed out on the ground; A spontaneous report was received from a consumer concerning a 22-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed out on the ground and had a severe anaphylaxis allergic reaction. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. About 10 minutes after receiving the second dose of the Moderna vaccine, the patient passed out on the ground having a severe anaphylaxis allergic reaction. Treatment for the event included two doses of epinephrine IM in addition to diphenhydramine, ondansetron, and steroids to prevent a rebound reaction. 911 was called and after epinephrine and diphenhydramine were administered, the patient was immediately transported to the hospital where she stayed for 6 more hours for observation, fluids, and further medications. Action taken with mRNA-1273 in response to the events was not applicable. The events, passed out on the ground and severe anaphylaxis allergic reaction, were considered resolved; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Anaphylactic reaction is a listed event in CCDS.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Anaphylactic reaction', 'Loss of consciousness']",2,MODERNA,OT 1056498,NY,44.0,F,"Vaccine was withdrawn from arm and some of the vaccine dripped out; A spontaneous report was received from a consumer regarding herself, a 44-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some of vaccine leaking out of the injection site/accidental underdose. The patient's medical history was not included. Products known to have been used by the patient were not included. First dose information was not provided. On 11 Feb 2021, prior to the onset of the events, the patient received the second of two doses of mRNA-1273 (Lot number: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 11 Feb 2021, as the needle was withdrawn, some of the vaccine leaked out. The patient is concerned about underdose. Treatment information was not provided. Action taken with mRNA-1273 was not applicable. The outcome of the events, vaccine leaking out when needle was withdrawn, was considered resolved.; Reporter's Comments: This case concerns a 44-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Accidental underdose without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Accidental underdose'],2,MODERNA,OT 1056499,,,U,"UTI; cough; A spontaneous report was received from a consumer concerning a patient who developed/experienced hospitalization for 7 days UTI, cough, MedDRA PT: hospitalization, urinary tract infection, cough The patient's medical history was not provided. The patient received their first of two planned doses of mRNA-1273 .Batch number not provided Treatment information was unknown. The patient scheduled to received the second shot of the vaccine. Patients reports having a bad reaction to the first shot; starting cough, and ended up with a UTI and ended up in the hospital for 7 days. Action taken with mRNA-1273 in response to the events were unknown. The outcome of the events were not reported.; Reporter's Comments: This case concerns a female of unknown age who experienced a ""bad reaction to the first shot"" and then was hospitalized with a serious unexpected event of UTI and a NS unexpected event of cough. The events occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Cough', 'Urinary tract infection']",1,MODERNA,OT 1056500,OK,40.0,M,"Inadvertently given vaccine from a vial that was punctured a day before; A spontaneous report was received from a physician concerning a 41-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was inadvertently given the vaccine from a vial that was punctured a day before (expired product administered). The patients' medical history was not provided. Concomitant product use was not provided. On 13 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch: 016M20A) intramuscularly for prophylaxis of COVID-19 infection. The reporter stated that the patient was inadvertently given the vaccine from a vial that was punctured a day before. A single dose was taken out of that vial and put back outside the six-hour window. Treatment information was not provided. The action taken with mRNA-1273 in response to the event was unknown. The event, was inadvertently given the vaccine from a vial that was punctured a day before, was considered resolved on 13 Feb 2021.; Reporter's Comments: This case concerns a 41-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot: 016M20A), reporting Expired product administered without any associated adverse events.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-013964:same reporter, different patient US-MODERNATX, INC.-MOD-2021-013965:same reporter, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/13/2021,0.0,UNK,,No adverse event (No reported medical history),,,,['Expired product administered'],1,MODERNA,OT 1056501,OK,,M,"inadvertently given vaccine from a vial that was punctured a day before; A spontaneous report was received from a physician regarding a 22-year-old male patient who inadvertently received Moderna's mRNA-1273 vaccine from a vial that was punctured the day before/expired product administered. The patient's medical history was not provided. Concomitant medications were not provided. On 13 February 2021, the patient received the first of two planned doses of mRNA-1273 (Batch: 016M20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 February 2021, it was noticed that the vial being used had been punctured the day before, beyond the 6-hour expiration. Treatment information was not provided. Action taken with mRNA-1273 was not provided. The outcome of the event, inadvertently given a vaccine from a vial that was punctured the day before, was considered resolved.; Reporter's Comments: This case concerns a 22-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot: 016M20A), reporting Expired product administered without any associated adverse events.; Sender's Comments: MOD-2021-013965:same reporter, different patient MOD-2021-013964:same reporter, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/13/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Expired product administered'],1,MODERNA,OT 1056502,AL,,M,"Vaccine given after sitting in room temperature for 6 hours and 25 minutes; A spontaneous report was received from a 57 year-old, male patient, age who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, vaccine given after sitting in room temperature for 6 hours and 25 minutes. The patient's medical history was not provided. No relevant concomitant medications were reported. On 14 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 007m20A) for prophylaxis of COVID-19 infection. On 14 Feb 2021, a dose of Moderna's vaccine was administered to the patient after sitting in room temperature for 6 hours and 25 minutes. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, expired vaccine used, was considered resolved on 14 Feb 2021.; Reporter's Comments: This report refers to a case of Expired product used for mRNA-1273(Batch number: 007m20A), with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/14/2021,02/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Expired product administered'],1,MODERNA, 1056503,NY,74.0,M,"When needle came out there was a squirt so maybe didn't get the full dose; A spontaneous report was received from a consumer concerning a 74 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced when needle came out there was a squirt so maybe didn't get the full dose (Product administration error, Incomplete dose administered). The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 14-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011L20A) on 14-JAN-2021. On 11-FEB-2021, approximately prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly in the for prophylaxis of COVID-19 infection. On 11-FEB-2021, during administration of the second dose, when the needle came out there was a squirt so he thought maybe he didn't get the full dose. Treatment information was not provided/unknown. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The outcome of the event was recovered on 11 Feb 2021.; Reporter's Comments: This is a case of 74-year-old male patient who was administered second dose of mRNA-1273 vaccine and experienced needle came out there was a squirt so maybe didn't get the full dose (Product administration error, Incomplete dose administered) Lot #: 030L20A. There was no associated adverse event reported for the events of Product administration error, Incomplete dose administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,02/11/2021,28.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no medical history reported),,,['Product administration error'],1,MODERNA, 1056504,CA,,U,"15 patients received doses from vials that were more than 6 hours post initial puncture; A spontaneous report was received from a health care professional concerning a 14 patients who received doses from vials that were more than 6 hours post initial puncture. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. The health care professional reported that they had four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture. The health care professional wanted to know if they needed to revaccinate those patients? During follow-up call: HCP stated that there were actually 14 patients that received doses from vials that more than 6 hours post initial puncture. The HCP was unable to provide any additional information at the time of the call and stated that a colleague would call back with further details. Consent for Safety to follow up with HCP was not provided as she does not have any additional information to Action taken with mRNA-1273 in response to the event was not provided/unknown. The event,14 patients received doses from vials that were more than 6 hours post initial puncture, was recovered/resolved.; Reporter's Comments: This report refers to a case of Product administration error where total of 15 patients had experienced expired product administration for mRNA-1273(unknown batch). This case had no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Expired product administered'],UNK,MODERNA,OT 1056505,TX,,M,"patient received first dose on 30Dec2020 and has not received second dose yet; A spontaneous report was received from a consumer concerning male patient of unknown age, who received Moderna's COVID-19 vaccine first dose and has not received second dose yet. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (Lot number:025L20A) unknown route of administration on 30 Dec 2020 for prophylaxis of COVID-19 infection. Patient stated he had missed his email for being able to return for his second dose. His first dose was on 30-Dec-2020. He returned to the same clinic on 28-Jan-2021 but they turned him away and told he will receive an email and he is still waiting on that. During a follow up call patient stated he was able to get in touch with an alternative vaccination site who advised him to come on 12-Feb-2021 and see if they will vaccinate him. Patient was unsure if they will vaccinate him since last time he showed up without an appointment and he was turned away. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event, Patient received first dose on 30-Dec-2020 and has not received second dose yet was considered resolved.; Reporter's Comments: This case concerns a male of unknown age who experienced a nonserious unexpected event of Inappropriate schedule of product administration for mRNA-1273 (lot # 025L20A) without associated adverse events. Patient received first dose mRNA-2173 on 30-Dec-2020 and has not yet received the second dose. The missed second dose of mRNA-1273 occurred 1 month and 13 days after the first dose of mRNA-1273. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,02/11/2021,43.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Inappropriate schedule of product administration'],1,MODERNA,OT 1056506,AL,80.0,F,"Headache around her temples and nose; Did not get full shot since syringe messed up; Did not get full shot since syringe messed up; A spontaneous report was received from a consumer concerning an 80-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced that she did not get the full shot since the syringe messed up/device connection issue, vaccine underdose and headache. The patient's medical history was not provided. Concomitant medications were not provided. On 15 FEB 2021, the patient received her second dose of mRNA-1273 (lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection. The patient stated that she received her vaccine on 15 FEB 2021, but the syringe messed up and she didn't get the full dose. The healthcare professional (HCP) told her to come back on 18 FEB 2021 for the full dose. On 16 FEB 2021 the patient woke up with a headache around her temples and nose. Treatment for these events were not reported. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, device connection issue and vaccine underdose were recovered. The outcome of the event, headache was unknown.; Reporter's Comments: This case concerns a 80-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 025L20A), reporting device connection issue, vaccine underdose and associated headache. Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No adverse event history),,,"['Device connection issue', 'Headache', 'Underdose']",2,MODERNA,OT 1056507,IL,,M,"Bells Palsy; A spontaneous report was received from a consumer concerning a 65 year old male patient who experienced Bells Palsy/Facial Paralysis, Slurred speech/.Dysarthria, Facial droop/Facial droop, Numbness on Facial right side/ Facial Paresthesia, Thumb numbness/ Thumb Paresthesia, Right paralysis/Right Paralysis, Right eye lid will not close/Right Eyelid Paralysis The patient's medical history was not provided. Products known to have been used by the patient, within in two weeks prior to the events, included Insulin Zinc Suspension, Insulin Aspart, Clopidogrel bisulfate, Gabapentin, Mesalamine, and Atorvastatin. On 18-Jan-2021, prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 ( Batch number: 09L20A) intramuscularly into the right arm for prophylaxis of Covid-19 infection. On 15-Feb-2021 the patient received the second of two planned doses of mRNA-1273 ( Batch number: 024M20A) intramuscularly (site not provided) for prophylaxis of Covid-19 infection. On 15 Feb-2021, the patient left a voicemail message to safety and stated ""got right paralysis, thought I had stroke, spent 4 days in the hospital and diagnosed me with Bells Palsy"". Hospital admission, treatment information, and discharge dates were not provided. On 16-Feb-2021 Safety agent reached the patient to clarify the information provided in his first report (15-Feb-2021). The patient reported his symptoms began on 08-Feb-2021, 21 days following the first dose of mRNA-1273, the patient experienced slurred speech, facial droop , numbness on facial right side, thumb numbness, right paralysis, right eye lid will not close and blurred vision of the right eye. He was hospitalized (date not provided). Treatment information included a CT scan which was reported as normal . He reported seeing a speech therapist to help with his speech and improve swallowing. He reported no treatment was given to him. A physician diagnosed him with Bells Palsy on 10-Feb-2021. Hospital discharge date was not provided. The second dose of mRNA-1273 was temporarily withheld in response to the events rechallenge date 15-Feb-2021 was reported as negative. The outcome of the events, Bells Palsy,slurred speech, facial droop , numbness on facial right side, thumb numbness, right paralysis, right eye lid will not close and blurred vision of the right eye were considered Not recovered/Not resolved. Company Comment: the reported event Bells Palsy was considered possibly related to mRNA-1273.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/18/2021,02/08/2021,21.0,UNK,INSULIN LENTE [INSULIN ZINC SUSPENSION]; PLAVIX; NOVOLOG; GABAPENTIN; MESALAMINE; ATORVASTATIN,Palsy Bells (Symptoms started 08-Feb-2021 Diagnosed by physician 10-Feb-2021),,,,"['Computerised tomogram normal', 'Facial paralysis']",2,MODERNA,OT 1056508,TN,50.0,F,"anaphylactic reaction; A report was received from a healthcare facility staff member concerning a 50 year old, female patient (a nurse) who was participating in the mRNA-1273 Emergency Use Program and experienced an anaphylactic reaction. No relevant concomitant medications and medical history were reported. The patient received their first of two planned doses of mRNA-1273 on 19-DEC-2020. On 26-JAN-2021, the patient received their second of two planned doses of mRNA-1273 (Batch 030L20A) in her Left deltoid arm (IM injection) and on the same day, experienced the serious adverse event of anaphylactic reaction. She was transported by ambulance to the ER. She stayed there for one day and now is fine. Treatment included Benadryl, epinephrine, steroid, advance, peptide, Motrin. Laboratory details was not provided. The event, anaphylactic reaction, was considered recovered on 26-JAN-2021. Action taken with mRNA-1273 in response to the event was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/19/2020,01/26/2021,38.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Anaphylactic reaction'],1,MODERNA, 1056509,NJ,,F,"heart failure; blood sugar was really high; This is a spontaneous case report sent by a Non-Health Professional which refers to an 81-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cardiac failure and blood sugar was really high. The following drugs are known to have been taken by the patient prior to the event: Amlodipine ,atorvastatin, Breo, Diovan, furosemide, metoprolol, Xarelto, Trulicity On 30-Jan-2021 the patient took the first dose of the Moderna COVID-19 Vaccine for COVID-19 infection. On the next day ('Sunday"") her blood sugar was high and on Monday the patient developed heart failure and she is not attributing the heart failure to the vaccine but is wondering if her blood sugar is high due to the vaccine or CHF. Gliperide and metformin are the treatment for symptoms. Relevant laboratory results included. The hospital discharge summary was not available. The eventual diagnosis made on was cardiac failure . Patient wants to know that she should take second dose of vaccine. The Non-Health Professional did not declare any relatedness between heart failure and Moderna COVID-19 Vaccine Terse Narrative (for narratives and signal review) Brief 3 line summary of above for agency listing: Report Source- Non-Health Professional, Age- 81 Years, Sex- Female, Suspect Drug- Moderna COVID-19 Vaccine, Treatment- Diagnosis\Outcome- heart failure - Unknown,blood sugar was really high - Unknown.; Reporter's Comments: Based on the information provided, a causal association between the reported events and the administration of mRNA-1273 is assessed as unlikely. Causality is confounded by the patient's underlying medical history suggestive in concomitant therapy. Additional information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/30/2021,01/31/2021,1.0,UNK,AMLODIPINE; ATORVASTATIN; BREO ELLIPTA; DIOVAN; FUROSEMIDE; METOPROLOL; XARELTO; TRULICITY,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Blood glucose increased', 'Cardiac failure']",1,MODERNA,OT 1056510,NY,,U,"was accidentally given a second dose of the Moderna version of the shot, instead of a second dose of the Pfizer shot; A spontaneous report was received from a other healthcare professional concerning an unknown patient who was accidentally given a second dose of the Moderna version of the shot, instead of a second dose of the Pfizer shot. Lot number and expiration date for mRNA-1273 were not reported Medical history and concomitant medications were not reported. No additional information relevant to the event was reported. Action taken with the second dose of mRNA-1273 in response to the event was unknown.; Reporter's Comments: This report refers to a case of accidentally given a second dose of the Moderna version of the shot, instead of a second dose of the Pfizer shot for mRNA-1273, lot# (unknown) with no associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Wrong product administered'],2,MODERNA,OT 1056511,NC,62.0,F,"lost hearing in right ear; ringing in the ear; A spontaneous report was received from a 62-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced ringing in the ear and loss of hearing in the right. The patient's medical history was not provided. Products known to have been used by the patient were not included. On 03 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced ringing in the ear and lost hearing in the right ear. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, ringing in the ear and lost hearing in the right ear was not reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Deafness unilateral', 'Tinnitus']",UNK,MODERNA,OT 1056512,OH,56.0,F,"Bell's Palsy; body aches; Pain in the head; Neck pain; Jaw pain; A spontaneous reportwas received from a 56-years-old, female patient who experienced jaw pain, neck pain, pain in the head, body aches and bells palsy. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine sodium, fluticasone propionate, loratadine, vitamin E, vitamin B, vitamin C, ibuprofen and tizanidine. On 26 Jan 2021, approximately fifteen days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 2039K20A] intramuscularly for prophylaxis of COVID-19 infection. On 10 Feb 2021, the patient experienced jaw pain, neck pain, head pain and body aches. On 14 Feb 2021, she was diagnosed with Bells palsy after going to urgent care . Treatment for the event included valaciclovir hydrochloride, salve for eye, steroid ear drop. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events jaw pain, neck pain, pain in the head, body aches and bell's palsy were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,02/10/2021,15.0,UNK,SYNTHROID; FLONASE [FLUTICASONE PROPIONATE]; CLARITIN [LORATADINE]; VITAMIN E [VITAMIN E NOS]; VITAMIN B [VITAMIN B NOS]; VITAMIN C [ASCORBIC ACID]; ADVIL [IBUPROFEN]; TIZANIDINE,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Facial paralysis', 'Headache', 'Myalgia', 'Neck pain', 'Pain in jaw']",1,MODERNA,OT 1056513,,,F,"Passed out; Shakes so bad; So sick; Headache; Muscle pain; Temperature for five days (102.7F); A spontaneous report was received from a consumer, female patient of unknown age, with unknown race and ethnicity, who was administered Moderna's COVID-19 Vaccine (mRNA-1273) and experienced passed out (loss of consciousness), shakes so bad (tremor), so sick (malaise), headache, muscle pain (myalgia), and temperature for five days (102.7F) (pyrexia). The patient's medical history was not provided. No concomitant medications were reported. On an unknown date in JAN 2021, the patient received their first of planned doses of mRNA-1273 (batch number: unknown), intramuscularly for prophylaxis of COVID-19 infection. The patient reported that the difficulties which she experienced after the first Moderna vaccine were terrible and so bad. The patient had all the side effects, which includes headache, muscle pain, passed out, fever, and was so sick. The patient wanted to report the side effects and unsure if she should take the second vaccine or not. The patient doesn't think that she can handle the second vaccine. She had a temperature of 102.7 F and was shaking so bad. The patient second vaccine was due in 28 days in February. Upon callback, the patient had a hard of hearing and stated that the vaccine hit her hard and had a temperature for five days. She was concerned about getting the second dose. No treatment medication information was reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, passed out, shakes so bad, so sick, headache, muscle pain, and temperature for five days (102.7F), were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Body temperature', 'Headache', 'Loss of consciousness', 'Malaise', 'Myalgia', 'Pyrexia', 'Tremor']",1,MODERNA,OT 1056514,GA,17.0,M,"17 year-old received the Moderna COVID-19 vaccine; A spontaneous report was received from a nurse concerning a 17-year-old, male who received Moderna's COVID-19 vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12-Feb-2021, prior to the onset of the event, the patient received their first of two planned does of mRNA-1273 (Lot number: 012M20A) for prophylaxis of COVID-19 infection. On 12-Feb-2021, the patient was administered mRNA-1273 vaccine. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event, 17-year-old received the Moderna COVID-19 vaccine, was considered resolved on 12 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 012M20A) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1056515,FL,67.0,F,"left side of face began to tingle and be numb; left side of face began to tingle and be numb; 2 episodes of rapid heartbeat; burning in arm; lips and tongue started swelling; tongue started swelling; severe headache; A spontaneous report was received from a consumer reporting on herself, a 67-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced left side of face began to tingle and be numb/MedDRA PT: Hemiparesthesia, rapid heartbeat/MedDRA PT: tachycardia, burning in arm/MedDRA PT: vaccination site burning, lips started swelling/MedDRA PT: swelling of lips, tongue started swelling/MedDRA PT: swelling of tongue, severe and headache/MedDRA PT: headache. The patient's medical history included allergy to latex and reaction to oseltamivir phosphate (Tamiflu).Products known to have been used by the patient, within two weeks prior to the event, included losartan, potassium citrate, diltiazem, allopurinol, atorvastatin, famotidine and levocetirizine. On 12 Feb 2021, the patient received the first of two planned doses of mRNA-1273 ([LOT# 015M20A]) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Four minutes after the vaccination, the patient felt burning in her arm and the left side of her face began to tingle and feel numb. In addition, the patient's lips and tongue began to swell and she had 2 episodes of rapid heart rate. Within 20 minutes it started to resolved and then she developed a severe headache. On 13 Feb 2021, the patient reported that all of the symptoms were back except the fast heartbeat. The patient called Urgent Care and was prescribed treatment with diphyendramine and famotidine. On 14 Feb 2021, the patient went to the emergency room and received a steroid injection, ""liquid to drink"", and steroid medication for 5 days. She reported a history of a similar reaction to oseltamivir phosphate (Tamiflu). Action taken with mRNA-1273 in response to the events was not reported. The outcome of events of left side of face began to tingle and be numb, 2 episodes of rapid heartbeat, burning in arm, lips and tongue started swelling and severe headache (12 Feb 2021) were considered recovered/resolved. The outcome of events of left side of face began to tingle and be numb, burning in arm, lips and tongue started swelling and severe headache (13 Feb 2021) were considered unknown; Reporter's Comments: This case concerns a 67-year-old female, with latex and drug allergies, who had serious unexpected hemiparesthesia and hypoaesthesia, NS unexpected lip swelling, swollen tongue, tachycardia, and NS expected vaccination site pain, headache. Event onset 4 minutes after first dose of mRNA-1273. Treated with Benadryl and steroids. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,UNK,LOSARTAN; POTASSIUM CITRATE; DILTIAZEM; ALLOPURINOL; ATORVASTATIN; FAMOTIDINE; LEVOCETIRIZINE,Drug allergy (Unspecified reaction to Tamiflu); Latex allergy (Allergy to latex.),,,,"['Headache', 'Hemiparaesthesia', 'Hypoaesthesia', 'Lip swelling', 'Swollen tongue', 'Tachycardia', 'Vaccination site pain']",1,MODERNA,OT 1056516,AZ,,F,"Sore arm; Pulled the dose from multiple vials (2-3 vials) to complete the 0.5ML; A spontaneous report was received from a pharmacist, concerning her mother, a 57-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) where in pulled the dose from multiple vials (2-3 vials) to complete the 0.5 ML and developed sore arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On 16 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot: 00UM20A) for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient's vaccine dose was pulled the from multiple vials (2-3 vials) to complete the 0.5 ML. Patient also experienced sore arm. Laboratory details not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the event Pulled the dose from multiple vials (2-3Vials) to complete the 0.5ML was considered resolved on 16 Feb 2021. The outcome of event sore arm was considered unknown at the time of this report.; Reporter's Comments: This report refers to a case of Inappropriate drug extraction with syringe for mRNA-1273, lot # 00UM20A with sore arm. developed",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Pain in extremity', 'Wrong technique in product usage process']",1,MODERNA, 1056517,NE,78.0,F,"Got their second vaccine earlier than they should have; A spontaneous report was received from a nurse regarding a 78-year-old female patient who received Moderna's mRNA-1273 vaccine earlier then she should have/inappropriate schedule of vaccine administered. The patient's medical history was not provided. Concomitant medications were not provided. On 04 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch: unknown) for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Batch: 024M20A) for prophylaxis of COVID-19 infection. On 16 Feb 2021, accidently patient got through and got their second vaccine earlier than they should have. Patient got their first dose of the Moderna vaccine at a different place, that's how this ended up happening. Treatment information was not provided. Action taken with mRNA-1273 was not applicable. The outcome of the event, receiving the vaccine earlier than she should have, was considered resolved on 16 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/16/2021,12.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Inappropriate schedule of product administration'],2,MODERNA,OT 1056518,NJ,84.0,M,"The coroner said it was some type of heart attack; A spontaneous Report Received from a Health care professional concerning a 84 year old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced a heart attack / myocardial infarction. The patient's had undergone triple bypass surgery years ago. Concomitant medications were vitamins. On 18-Jan-2021 prior to onset of events the patient received his first of first two planned doses of (mRNA-1273) COVID-19 vaccine of unknown batch no, unknown route and unknown site of administration for prophylaxis of COVID-19 infection. On 13-Feb-2021 the patient experienced death 27 days after the first dose of the vaccine. The coroner said it was some type of heart attack and think he expired sometime Saturday 13-Feb-2021. On 16-Feb-2021 the patient was supposed to have his second dose of (mRNA-1273) COVID-19 vaccine. The event, heart attack, was fatal.; Reporter's Comments: This is a case of death to heart attack in a 84-year-old female subject with a hx of triple bypass surgery, who died 27 days after receiving first dose of vaccine. Very limited information has been provided at this time. No death certificate provided. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of Death",Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,01/18/2021,02/13/2021,26.0,UNK,VITAMINS NOS,,Medical History/Concurrent Conditions: Bypass surgery,,,['Myocardial infarction'],1,MODERNA,OT 1056520,ID,16.0,F,"Headache; 16 years old received vaccine; A spontaneous report was received from a patient concerning a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache and 16 years old received vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On 21-Jan-2021, prior to the onset of the events, the patient received their first dose of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 23-Jan-2021, the patient experienced headache for a couple of days. Treatment for the event included ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, headache and 16 years old received vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of product administration error � Product administered to patient of inappropriate age for mRNA-1273, lot # unknown with event of headache.Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Headache', 'Product administered to patient of inappropriate age']",1,MODERNA,OT 1056521,IL,65.0,F,"Her Behcet's disease was in remission for three years but after 18 hs of the shot it reappeared; tingling; sore arm; A spontaneous case was received from the consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine and experienced sore arm, tingling and Behcet's disease. The patient's medical history was not provided. No relevant concomitant medications was reported. On 29 Jan 2021 prior to the onset of the events, the patient received first of the two planned doses of mRNA-1273 (Lot Number:026L20A) for the prophylaxis of COVID-19 infection. On 29 Jan 2021 the patient experienced sore arm and tingling. Her Behcet's disease / systemic vasculitis (lupus like element) which was in remission for three years reappeared 18 hours after the shot. Treatment of the event was not reported. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events, sore arm, tingling was not provided. But the outcome of the event for her Behcet's disease was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,UNK,,Behcet's disease aggravated,,,,"[""Behcet's syndrome"", 'Paraesthesia', 'Vaccination site pain']",1,MODERNA,OT 1056522,NY,39.0,U,"Fatigue; could not walk; A spontaneous report was received from consumer concerning a 39-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue and could not walk. Medical history was not reported. Concomitant medication was not reported. On 19-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route in unknown anatomical location for prophylaxis of COVID-19 infection and developed fatigue. On 21-Jan-2021, the patient could not walk and was hospitalized. Laboratory details was not provided. Treatment medication was not provided. Action taken with mRNA-1273 in response to the events fatigue and could not walk was not provided. The outcome of the events fatigue and could not walk was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/19/2021,01/21/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported Medical history),,,"['Fatigue', 'Gait disturbance']",1,MODERNA, 1056523,MD,58.0,U,"drug administered at inappropriate site; injection site hot to touch; Two-inch red circle at injection site; A spontaneous report was received from a Consumer concerning a 58 -Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site erythema and injection site warmth. The patient's medical history was not provided. No relevant concomitant medications were reported. On 13 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 02TJ20A) in the deltoid for prophylaxis of COVID-19 infection. On 13 Feb 2021, The patient was concerned now whether they gave her the shot in the deltoid muscle and concerned if it was still effective? Also about eight days later she developed a 2 inch red circle that was hot to the touch. Laboratory details not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. In Feb-2021, the outcome of the injection site erythema and injection site warmth resolved. On 13 Feb 2021, the event was product administered at inappropriate site was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of vaccination site erythema and vaccination site warmth, a causal relationship cannot be excluded. The causality for vaccine administered at inappropriate site is not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Product administered at inappropriate site', 'Vaccination site erythema', 'Vaccination site warmth']",1,MODERNA,OT 1056524,HI,,F,"Given 1 ml of vaccine instead of 0.5ml; A spontaneous report was received from a pharmacist concerning a female patient, received Moderna's COVID-19 Vaccine and was given Moderna's vaccine 1ml instead of 0.5ml. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 016M20A) on 09 Feb 2021, intramuscularly in left arm for the prophylaxis of COVID-19 infection. On 09 Feb 2021, the patient received 1ml of the vaccine instead of 0.5ml. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, given Moderna's vaccine 1ml instead of 0.5ml, was considered resolved on 09 Feb 2021.; Reporter's Comments: This reports refers to a case of Accidental overdose for mRNA-1273 (Batch number: 016M20A) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Accidental overdose'],1,MODERNA,OT 1056525,HI,,M,"Given 1 ml of vaccine instead of 0.5ml; A spontaneous report was received from a pharmacist concerning a 33-year old, male patient who received Moderna's COVID-19 Vaccine and was given Moderna's vaccine 1ml instead of 0.5ml. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 016M20A) on 09 Feb 2021, intramuscularly in left arm for the prophylaxis of COVID-19 infection. On 09 Feb 2021, the patient received 1ml of the vaccine instead of 0.5ml. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, given Moderna's vaccine 1ml instead of 0.5ml, was considered resolved on 09 Feb 2021.; Reporter's Comments: This reports refers to a case of Accidental overdose for mRNA-1273 (Batch number: 016M20A) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Accidental overdose'],1,MODERNA,OT 1056526,HI,,M,"Given 1 ml of vaccine instead of 0.5ml; A spontaneous report was received from a pharmacist concerning a 35-year old, male patient who received Moderna's COVID-19 Vaccine and was given Moderna's vaccine 1ml instead of 0.5ml. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 016M20A) on 09 Feb 2021, intramuscularly in left arm for the prophylaxis of COVID-19 infection. On 09 Feb 2021, the patient received 1ml of the vaccine instead of 0.5ml. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, given Moderna's vaccine 1ml instead of 0.5ml, was considered resolved on 09 Feb 2021.; Reporter's Comments: This reports refers to a case of Accidental overdose for mRNA-1273 (Batch number: 016M20A) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Accidental overdose'],1,MODERNA,OT 1056528,IL,74.0,F,"still a part of her forehead that feels like a live nerve; upper back started hurting/back was very tender and sensitive around the spine area; arm was a little sore; pharmacist had some left over in the vial and gave her that; has post traumatic neuralgia"" related to her shingles; Shingles; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 29Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from two contactable consumers via medical information team. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date: unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. Medical history included dental work/specifying a tooth being pulled and an implant (an antibiotic (Amoxicillin)) was used and shingles (7 years ago). The patient's concomitant medications were not reported. It was reported that Pharmacist had some left over in the vial and gave the patient on 28Jan2021. Patient wanted to make sure it was ok. Patient stated ""she got shingles on her face, 7 years ago, and had recent dental work done,"" specifying a tooth being pulled and an implant. She stated she received the first dose of the COVID-19 vaccine last Thursday evening (28Jan2021). On 29Jan2021 and 30Jan2021 (friday and saturday), she mentioned, her ""arm was a little sore"". On 30Jan2021 and 31Jan2021 (saturday evening and sunday morning) she said her ""upper back started hurting"" and thought ""maybe [she] sat on the couch for too long"". On 31Jan2021 (Sunday evening), she added her ""back was very tender and sensitive around the spine area"" therefore, she ""took some tylenol and used a heating pad thinking [she] pulled a muscle"". On 01Feb2021 (By Monday) she said her ""the back and front were very sensitive"" to the point where: when she ""touched [her] skin it felt like [she] was touching some live nerves"". She explained seeing a physician assistant who ""couldn't figure out what was going on"" and since it seemed to be getting worst, she thought she could possibly have Shingles. She continued saying she then ""went to see an orthopedic doctor who took x-rays and said he doesn't see anything, and it may be the beginning phases of Shingles"". She mentioned she has an appointment with her internist today at 4:20. She later mentioned her ""brother, who is a doctor, thinks [she] has post traumatic neuralgia"" related to her shingles on an unspecified date in Jan2021. She then added there is ""still a part of her forehead that feels like a live nerve"" to touch, since having Shingles, on 01Feb2021. The outcome of the events was unknown. The outcome of the events was unknown. The information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Dental implantation (an antibiotic (Amoxicillin) was used.); Shingles (7 years ago),,,"['Back pain', 'Feeling abnormal', 'Herpes zoster', 'Pain in extremity', 'Post-traumatic neuralgia', 'Product administration error', 'X-ray']",1,PFIZER\BIONTECH, 1056529,IN,56.0,F,"Itching; fever; chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female nurse received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via unknown route of administration, on 25Jan2021 at 08:15 AM (at the age of 56 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included hypothyroid and had BNT162B2 vaccine dose 1 on unknown date, lot unknown, administered at 10:45 AM on right arm. The patient had known allergies: Ibuprofen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), sertraline hydrochloride (ZOLOFT), liothyronine sodium (CYTOMEL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received levothyroxine, sertraline hydrochloride, liothyronine sodium within 2 weeks of vaccination. On 25Jan2021, at 12:00 PM, the patient experienced Itching, Fever, Chills. No treatment was received for the events Itching, Fever, Chills. The outcome of the events Itching, Fever, Chills was not recovered. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,PVT,SYNTHROID; ZOLOFT; CYTOMEL,,Medical History/Concurrent Conditions: Hypothyroidism,,,"['Chills', 'Pruritus', 'Pyrexia']",2,PFIZER\BIONTECH, 1056530,OK,44.0,F,"Sore arm; Sore neck; Swollen lymphnode under my left arm; This is a spontaneous report from a contactable 44-year-old female consumer (patient). A 44-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via unknown route of administration, on 14Jan2021 at 10:00 AM (at the age of 44 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history included allergy to codeine, was diagnosed with COVID-19 prior to vaccination and had BNT162B2 vaccine dose 1 on unknown date, lot unknown. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications was not provided. The patient did not receive any other vaccines within 4 weeks or any medications within 2 weeks prior to the COVID vaccine. On 16Jan2021, at 08:00 AM, the patient experienced sore arm, sore neck and swollen lymph node under my left arm. No treatment was received for the events sore arm, sore neck and swollen lymph node under my left arm. The outcome of the events sore arm, sore neck and swollen lymph node under my left arm was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/16/2021,2.0,UNK,,,"Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?:Yes)",,,"['Lymphadenopathy', 'Neck pain', 'Pain in extremity']",2,PFIZER\BIONTECH, 1056531,GA,75.0,F,"racing heart; This is a spontaneous report from a contactable consumer, the patient. This 75 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 , single dose via an unspecified route of administration in the left arm on 25Jan2021 at 15:00 (at the age of 75 years old) for COVID-19 vaccination. There was no relevant medical history. There were no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 26Jan2021, the patient had a racing heart. The event was reported as non-serious. There was no treatment received for the event. The clinical outcome of racing heart was recovered on an unknown date. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/26/2021,1.0,SEN,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Palpitations'],1,PFIZER\BIONTECH, 1056532,FL,,F,"She has a bump in her mouth; Dental work done gums are inflamed; This is a spontaneous report from a contactable consumer. This is a spontaneous report from a contactable consumer, the patient. This female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 11Jan2021 for COVID-19 vaccination. Medical history included dental work on an unknown date. Concomitant medications were not reported. In Jan2021, the patient had dental work done and gums are inflamed and has a bump in her mouth. The events were reported as non-serious. The clinical outcome of gums are inflamed and has a bump in her mouth was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Dental treatment (Dental work),,,"['Gingival swelling', 'Oral disorder']",1,PFIZER\BIONTECH, 1056533,TN,,F,"had arm soreness in her left arm from the injection; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that: A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration in left arm on 22Jan2021 8:00 at single dose for COVID-19 immunization. The patient medical history included Transient ischaemic attack (TIA) which was not ongoing. The patient's concomitant medications were not reported. The patient previously took 2 baby aspirin (162 mg) every evening and has done this for the past 15-20 years for Transient ischaemic attack. Received call from consumer regarding the Pfizer COVID vaccine. The reporter who asks if taking her regular regimen of 2 baby aspirin daily will interfere with the vaccine effectiveness. She had first covid vaccine dose Friday on 22Jan2021 at 8 am. She had no reaction other than a little soreness in her arm from the injection after getting the vaccine in Jan2021 and it went away in a couple of days. She just massaged her arm and it was fine. She reported that due to a history of TIA she took 2 baby aspirin every evening and has done this for the past 15-20 years. After getting her vaccine she was told that taking aspirin may interfere with the antibody response and she called today to ask if that was true and if she should take an antibody test. She was reading on some links yesterday about blood thinners. It kind of freaked her out. She took 2 baby aspirin daily and together it was 162 mg, which she has been taking for years. She used to get trans ischemic attacks and has not had any since she has been taking them. She took them at 6 pm, which she did the evening before she had the vaccine. She called to check, to see if taking 2 baby aspirin every day for the past 15 to 20 years would affect the vaccination that she got. She asked because she had someone telling her after getting the vaccine, oh you shouldn't have done that and so she called to check and to see if that was okay. She would be taking second dose on 12Feb2021. She would like to know if that reduced the effectiveness for her. She had not heard that anywhere previous or she would have stopped taking the aspirin 5 days prior. She was feeling fine. The outcome of the event 'arm soreness in her left arm from the injection' was recovered in Jan2021. Information about lot and batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Transient ischaemic attack,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1056534,FL,93.0,M,"Really bad case of diarrhea/worst case of diarrhea he has ever had; Shrunk to about 5'10''; This is a spontaneous report from a contactable consumer (patient). A 93-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 25Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 25Jan2021, after the first dose of vaccination, the patient had a really bad case of diarrhea, and mentioned that it was the worst case of diarrhea he has ever had. In Jan2021, the patient had shrunk to about 5'10"". The outcome of the events, 'diarrhea' and 'shrunk to about 5'10""', was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/01/2021,,UNK,,,,,,"['Body height', 'Body height decreased', 'Diarrhoea']",1,PFIZER\BIONTECH, 1056535,NE,48.0,F,"Fever; cough; diarrhea; swelling; burning; This is a spontaneous report from a contactable consumer. A 48-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK4176) via an unspecified route of administration in right arm on 22Jan2021 12:00 at single dose for COVID-19 immunisation. The patient received the vaccine in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. The patient received unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fever, cough, diarrhea, swelling, burning on 22Jan2021 16:00. The patient didn't receive any treatment for events. The outcome of events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Allergy,,,"['Burning sensation', 'Cough', 'Diarrhoea', 'Pyrexia', 'Swelling']",1,PFIZER\BIONTECH, 1056537,TN,63.0,F,"Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb; Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb/Arm still has this sensation (like sleep, cold, numb feeling); Arm still has this sensation (like sleep, cold, numb feeling); Fever 102 degrees Fahrenheight; Feeling sick; Chills; Shakes; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date: Mar2021), intramuscularly on the left arm on 07Jan2021 (09:00) at a single dose for COVID-19 immunization at the school/student health clinic (not a military facility). Medical history included ongoing rheumatoid arthritis diagnosed about 5 years ago; ongoing high blood pressure diagnosed a couple of years ago, and ongoing Grave's disease diagnosed about 30-32 years ago. Concomitant medications included ongoing hydroxychloroquine phosphate (PLAQUENIL) for rheumatoid arthritis; and levothyroxine sodium (SYNTHROID) for Grave's disease. On 07Jan2021, the patient had cold sensation in the arm, tingly sensation down in her arm like her arm was cold/numb; arm still had the sensation (like sleep, cold and numb feeling); had fever with body temperature of 102 degrees Fahrenheit; was feeling sick; had chills; shakes; and fatigue. The outcome of the events was not recovered for 'cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb' and 'arm still had the sensation (like sleep, cold and numb feeling)'; was recovered on 09Jan2021 for 'fever with body temperature of 102 degrees Fahrenheit', 'chills', 'shakes' and 'fatigue'; and was recovered in Jan2021 for 'feeling sick'. The patient was asking if these same symptoms should be expected after the second dose, and if it would be okay to get the second dose of vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,SCH,PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]; SYNTHROID,Blood pressure high (diagnosed a couple of years ago); Graves' disease (diagnosed about 30-32 years ago); Rheumatoid arthritis (about 5 years ago),,,,"['Body temperature', 'Chills', 'Fatigue', 'Hypoaesthesia', 'Malaise', 'Paraesthesia', 'Peripheral coldness', 'Pyrexia', 'Tremor']",1,PFIZER\BIONTECH,OT 1056538,PA,50.0,F,"the room was spinning/whole room was spinning; dizzy spells/more of when she is in a certain position like when she is reaching up to get something or bending down, or at night when she reclines or is switching from side to side; her scalp was itching and her back and stomach was itching; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 21Jan2021 15:00, at single dose, for COVID-19 immunization. There were no medical history and concomitant medications. On 21Jan2021 at 15:00 (last Thursday), the patient received the first dose. On 22Jan2021 (the day after the vaccine) at 07:00, her scalp was itching and her back and stomach was itching and that went away the same day. In the morning of 23Jan2021 (also reported as ""either 22Jan2021 or 23Jan202""), the patient had dizzy spells, more of when she is in a certain position like when she is reaching up to get something or bending down, or at night when she reclines or is switching from side to side. She stated that it usually happens when bending over, reaching up high, in a recline position or when switching sides on the pillow. She reported that she is still experiencing this symptom with no improvement and reported that dizziness worsened. In the morning of 26Jan2021, the patient reported that it was worst, the whole room was spinning but that spell went away after a few seconds. The patient reported her second dose was scheduled on 11Feb2021 and asked if the side effects after the second dose will be worse. The patient did not visit the emergency room and physician office. The outcome of the event ""dizzy spells/more of when she is in a certain position like when she is reaching up to get something or bending down, or at night when she reclines or is switching from side to side"" was not recovered; ""the room was spinning/whole room was spinning"" was recovered on 26Jan2021 (reported as ""went away after a few seconds""); and ""her scalp was itching and her back and stomach was itching"" was recovered on 22Jan2021 (also reported as recovered on 23Jan2021). Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/22/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dizziness postural', 'Pruritus', 'Vertigo']",1,PFIZER\BIONTECH, 1056539,CA,70.0,F,"stuffy nose; like a cold but it doesn't feel the same as a cold; This is a spontaneous report from a contactable consumer(patient). A 70-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3246), intramuscular at Arm Left on 17Jan2021 07:30 at the 70 years old at single dose for COVID-19 vaccination. The medical history included asthmatic. The concomitant medications were none. The patient had the first dose of the vaccine on the morning of 17Jan2021 and that afternoon on 17Jan2021 she started having a stuffy nose like a cold but it doesn't feel the same as a cold. This has been occurring for 9 days now. She called to ask if this was one of the more obscure side effects of the vaccine. The patient received the vaccination on the 17Jan2021, and in the afternoon of that day, she got a stuffy nose. She said that she did not see it as a side effect, but 9 days later she still has a stuffy nose. She said that she does not have a temperature, headache, or anything else going on. She said that she knows a stuffy nose is a side effect of Covid-19 though. The caller said that she has been reporting this on the (App Name) everyday. The patient said that the stuffy nose was the same as it had been. The patient said that she was not feeling sick, sick, just stuffed up. She did not have shortness of breath or anything like that. There was no History of all previous immunization with the Pfizer vaccine considered as suspect. The events did not require a visit to Emergency Room and Physician Office. There was no family Medical History Relevant to events. There was none Prior Vaccinations within 4 weeks. There were none relevant tests. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/17/2021,01/17/2021,0.0,OTH,,,Medical History/Concurrent Conditions: Asthmatic,,,"['Nasal congestion', 'Nasopharyngitis']",1,PFIZER\BIONTECH,OT 1056540,OH,84.0,F,"pressure all in her head and all over her body; pressure all in her head and all over her body; Feeling flushed; Nausea; feel her heart beating; legs feet and hands would feel tingly; She went to bed around 1am. This went on all night off and on. She slept maybe about 3 hours total.; This is a spontaneous report from a contactable consumer (patient). A 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number: Unknown, Batch/lot number: EL9261, Expiry Date: 31May2021), via an unspecified route of administration in the left arm on 22Jan2021 at 0.3 mL, single for she did not got COVID. Medical history included continuing A-fib, takes medication for this everyday. Diagnosed at least 10 years ago. The patient's concomitant medications were not reported. Last night (25Jan2021) her symptoms started. She was unsure if it was from the vaccine or not but she was thinking it was, she had not had it before. Around 11 pm last night (25Jan2021) she got a pressure all in her head and all over her body. She felt flushed. She had nausea. She could feel her heart beating. She could really feel it. It was not abnormal. She did have A-fib, but this was normal, not like A-fib. Her took her blood pressure which was normal. She took her pulse which was normal. She went to bed around 1am. This went on all night off and on. She slept maybe about 3 hours total. Sometimes her legs feet and hands would feel tingly. And the flushing continue- it feels like her body was hot, but it was not hot to the touch. She had felt better this morning when she got up, but she did have one bout when she was just sitting here. She had improved overall. Caller stated she already spoke to the safety department but did not have any reference number to provide. The outcome of event 'Feeling flushed' and 'Sometimes her legs feet and hands would feel tingly' was recovered on 26Jan2021, of the other events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/25/2021,3.0,UNK,,AFib (Verbatim: A-fib. Takes medication for this everyday. Diagnosed at least 10 years ago.),,,,"['Blood pressure measurement', 'Discomfort', 'Flushing', 'Head discomfort', 'Heart rate', 'Heart rate increased', 'Insomnia', 'Nausea', 'Paraesthesia']",1,PFIZER\BIONTECH, 1056541,,58.0,F,"continues vomiting; developed Migraine headache and is gotten worse ever since; This is a spontaneous report received from a contactable consumer (patient's husband). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 25Jan2021, at single dose, for COVID-19 immunization. The patient medical history concomitant medications were not reported. It was reported that the patient got the COVID-19 shot in the morning of 25Jan2021 (yesterday) which developed into a migraine headache that has done nothing but gotten worse and on 26Jn2021, she had continued vomiting. The reporter asked if these were normal and how long will these last. The outcome of the events was not recovered. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,UNK,,,,,,"['Migraine', 'Vomiting']",UNK,PFIZER\BIONTECH, 1056542,,,F,"her blood pressure also dropped; broke out in sweat; real hot flush again; the room turned a certain color, yellow, she was pale and white, and she could tell that she was going to pass out; the room turned a certain color, yellow, she was pale and white, and she could tell that she was going to pass out; she was pale and white; This is a spontaneous report from a contactable nurse (patient's mother). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; dose 1) via an unspecified route of administration on an unspecified date ""3 weeks ago"" as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Fifteen minutes after the vaccination, the patient ""broke out in sweat,"" sat down on a table where she laid her head, and felt better after drinking ""coke."" Two and a half hours later, the patient felt a real hot flush again, the room turned a certain color, yellow, she was pale and white, and she could tell that she was going to pass out. The patient's blood pressure also dropped. The patient was placed in a ventilated room on an inclined chair for an hour. The patient's mother wanted to know if the patient could receive the second dose of the vaccine given her reaction to the first dose. The outcomes of broke out in sweat, hot flush, the room turned a certain color, she was pale and white, she could tell that she was going to pass out, and blood pressure also dropped were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Blood pressure decreased', 'Blood pressure measurement', 'Dizziness', 'Flushing', 'Hyperhidrosis', 'Pallor', 'Visual impairment']",1,PFIZER\BIONTECH, 1056543,FL,91.0,M,"broke out with a terrible rash to his chest, groin and back with terrible itching; broke out with a terrible rash to his chest, groin and back with terrible itching; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3246 and Expiration Date unknown) via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included heart burn. The concomitant medications were reported as omeprazole (PRILOSEC) for heart burn. Patient took the Pfizer vaccine on 13Jan2021 and 1 and a half days later (evening of 14Jan2021) he broke out with a terrible rash all over his body on his chest, groin and back with terrible itching. He reports that he went to Urgent care/clinic and was prescribed prednisone for 6 days and reports that there is still a little bit there but the rash appears much better and stopped itching. The rash, it practically eliminated the rash there are still some signs of it but at the height of it, it was very vibrant and red. Also the second day he started taking another pill, Prilosec 20 mg for heart burn and he doesn't know if the rash was caused by the vaccine or the Prilosec but his question is, is that going to deter him from taking the second dose on 03Feb2021. Patient thinks he started the Prilosec either on the 14Jan2021 or 15Jan2021 and he stopped, after 2 tablets he stopped taking it because he wasn't sure, he didn't want to aggravate anything if it was caused by the Prilosec. Now asking for guidance of if he should receive the second dose. Treatment for events was prednisone. The outcome of itching was recovered in Jan2021. The outcome of rash was recovering. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,UNK,PRILOSEC [OMEPRAZOLE],,Medical History/Concurrent Conditions: Heartburn,,,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH, 1056544,,,M,"woke up with huge itchy all down from his rear end to his ankle and the back side of his leg; This is a spontaneous report from a contactable consumer reported for husband. A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Jan2021 16:30 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. No issues for a couple of days, but then in the middle of the night at 3 a.m. husband woke up with huge itchy all down from his rear end to his ankle and the back side of his leg, itch came to the front a little bit, took some Benadryl 50 mg and itch cream, it pretty much subsided. The event outcome was recovering. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,,,UNK,,,,,,['Pruritus'],1,PFIZER\BIONTECH, 1056545,,,F,"joint pain; This is a spontaneous report from a non-contactable consumer (patient). This female patient of unspecified age received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 22Dec2020 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient stated: ""I am having muscle... I guess is joint pain?"" The patient stated that she received her first dose of the Pfizer-BioNTech COVID-19 Vaccine on 22Dec2020 and also stated it was strange that she's experiencing those side effects on the left arm because she received the injection in the right arm. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,UNK,,,,,,['Arthralgia'],1,PFIZER\BIONTECH, 1056546,FL,74.0,F,"cheeks red and burning; cheeks red and burning; upper lip swelling; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via an unspecified route of administration in the left arm on 12Jan2021 at single dose for covid-19 immunisation. Medical history included allergic to a lot of antibiotics, always get reactions to drugs. Concomitant medications were unknown. The patient previously received ciprofloxacin (CIPRO) experiencing lip swelled, levofloxacin (LEVAQUIN) experiencing lip swelled, Prednisone experiencing burning cheeks. The patient experienced that her cheeks were red and burning, and upper lip swelling slightly, all on 12Jan2021. And it lasted a little over two hours. The patient was asking if it would be safe to take Benadryl before the 2nd dose of the vaccine. Outcome of all events was recovered on 12Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Adverse drug reaction; Allergic reaction to antibiotics,,,"['Burning sensation', 'Erythema', 'Lip swelling']",1,PFIZER\BIONTECH, 1056547,FL,71.0,M,"tightness of the total upper torso; muscle pain; chills; sweating; nausea; dizziness; weakness; headache; This is a spontaneous report from a contactable consumer reported for self. This 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan 2021 15:00 Left arm at single dose (Lot # FL7262) for covid-19 immunisation. Medical history included high blood pressure, diabetes, high cholesterol, covid prior vaccination, known allergies: Penicillin, codeine. No other vaccine in four weeks. Other medications in two weeks. He experienced tightness of the total upper torso, muscle pain, chills, sweating, nausea, dizziness and weakness, headache on 25Jan2021 03:00 AM. No covid tested post vaccination. No treatments were received. Outcome of the events was recovered in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/25/2021,4.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure high; COVID-19; Diabetes; High cholesterol; Penicillin allergy,,,"['Asthenia', 'Chills', 'Dizziness', 'Headache', 'Hyperhidrosis', 'Muscle tightness', 'Myalgia', 'Nausea']",1,PFIZER\BIONTECH, 1056548,MA,35.0,F,"Headache; This is a spontaneous report from a contactable consumer reported for herself. This 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 09:15 AM Left arm at single dose (Lot # EL4237) for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history was none. No Allergies to medications, food, or other products. Prior to vaccination, the patient did not diagnose with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. None other medications the patient received within 2 weeks of vaccination. Headache occurred about 1 hr after receive vaccine 26Jan2021 10:15 which was non serious, went away within 2 hours. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the event was recovered on 26Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Headache'],1,PFIZER\BIONTECH, 1056549,NY,63.0,F,"anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning sensation in her whole torso; fast heart rate; This is a spontaneous report from a contactable consumer reported for self and a contactable consumer (husband). This 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 09:00 on Arm left via Intramuscular at single dose (Lot # EL3247) for covid-19 immunisation. Medical history included allergic to penicillin when she was a kid. She said that her lips swelled up. No other products. Since receiving the vaccine, she's had a burnt taste in her mouth on 20Jan2021 and also reported that she had a burning sensation in her whole torso that lasted 2-3 mins after she received vaccine on 20Jan2021 and her heart rate was racing but resolved after a few minutes. She had a metallic taste in her mouth. It made her very anxious and she was having a fast heart rate on 20Jan2021. She got panicky because of the metallic taste. She clarified that the burning sensation she felt was a burning in her whole torso on 20Jan2021 and it was extremely hot like a chemical went into her body that was burning her guts. She said that the burning sensation only lasted 2-3 minutes and was gone. She said that she got scared and her heart was racing a little bit on 20Jan2021. Her heart racing resolved that same day after a little bit. She clarified that she has like a burnt taste in her mouth. She said that it is the roof of her mouth and her tongue that taste like this. The burnt taste is still ongoing. She said that she tried to call the physician, but has not heard back yet. She said that she had chills and no appetite that day on 20Jan2021, but it was gone by the next day 21Jan2021. Outcome of the event metallic taste in her mouth/ had a burnt taste in her mouth was not recovered. Outcome of the event burning sensation, fast heart rate was recovered on 20Jan2021. Outcome of the events chills and no appetite was recovered on 21Jan2021. Outcome of other event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Lip swelling; Penicillin allergy,,,"['Anxiety', 'Burning sensation', 'Chills', 'Decreased appetite', 'Dysgeusia', 'Heart rate increased']",1,PFIZER\BIONTECH,OT 1056550,MA,25.0,F,"slight soreness in my right arm; This is a spontaneous report from a contactable consumer report for self. A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) via an unspecified route of administration at right arm on 25Jan2021 15:30 at single dose for covid-19 immunization. The patient's medical history included allergies to Amoxil, but not severely. Patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medication within 4 weeks prior to the COVID vaccine included influenza vaccine, ethinylestradiol, levonorgestrel (KURVELO), fluoxetine hydrochloride (PROZAC). On 25Jan2021 05:00 PM, patient developed just slight soreness in right arm, but that usually happens to her when got any vaccine. No treatment received for the adverse event. Event outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,UNK,INFLUENZA VACCINE; KURVELO; PROZAC,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1056551,WI,67.0,F,"sore arm; diarrhea; bad taste in her mouth/can taste vaccine in her mouth and throat; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EL1283), via an unspecified route of administration on 26Jan2021 09:55 at single dose in the left arm for COVID-19 vaccination. Medical history and concomitant medications were none. Patient got her first injection of the COVID-19 vaccine on 26Jan2021 at 09:55AM in her left arm. Patient said that the diarrhea just started on 26Jan2021, she had tried calling earlier and had to hang up because of it, maybe because she was nervous. Patient said that she tasted the vaccine constantly, she has been experiencing a bad taste in her mouth, she couldn't stand the taste. Patient couldn't get rid of the taste. She said beforehand she was scared of anaphylactic shock, but she was having the taste in her mouth and diarrhea. She said she had the taste of the vaccine in her mouth and throat on 26Jan2021. She said that everything that she eats she is trying to get taste out of her throat. Patient has done no treatment yet for the diarrhea or the taste in her mouth. She said that her arm didn't hurt afterwards and she didn't feel the shot, and now she can't touch her arm without it hurting though she has been moving her arm a lot. She said she knew that from the flu shot, but that never hurt her, this thing was sore (sore arm) on 26Jan2021. She said she wasn't worried about that though, she just wanted to know if the taste would go away, and if it was normal. She said that there was nothing that said anything about diarrhea either, and she was not sick, she didn't feel sick, there was just the taste. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/26/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Diarrhoea', 'Dysgeusia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1056552,LA,80.0,F,"trouble breathing; This is a spontaneous report from a contactable consumer. A 80-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249), by injection once to upper right arm on 21Jan2021 at single dose for prevention. The patient medical history and concomitant medications were not reported. The patient experienced trouble breathing on 24Jan2021 with outcome of unknown. She got the vaccine shot last Thursday, later clarified as COVID vaccine, and she has read over the factual sheet given after the shot, she read it once quickly, will she be ok? She has difficulty breathing, one medication, she has that too, but not more often, with this she has been having it more often, she sleeps well during the night, it is just during the day. That was a severe reaction, two days ago or so, she can breathe sometime, but it's during the day, she read one dose effects say severe reaction, and it also says. she should have been given this paperwork before the vaccine, she didn't need it, she did not have an emergency, unless the second shot will be more helpful than one shot, after 3 weeks she gets another one. It says to call vaccine provider or healthcare professional if you have any effects that bother you or do not go away, how long do you wait until it doesn't go away? Why do they give the paperwork, why don't they give it at the doctor's office office before you set up an appointment to get vaccinated? Before so you can sit down and read the paperwork, she probably would not have gotten it, it says it is only only for emergency use for 16 and over, is this still a clinical trial, that information is not provided, and that burns her behind. She got the shot and 3 days later had the difficulty breathing, so she got it last Thursday, then started Sunday, Monday, into Tuesday, and it's just not. (caller did not complete sentence). Reporter email address declined. She hasn't told her doctor yet, provider's address and email address unknown. She thinks it started on Sunday, it wasn't yesterday, she thinks it was Sunday off and on, sometimes during day she can catch her breath, it may not be this or something, which is what she wants to find out, she is concerned with the idea this should not be sent out, she would not have gotten it. Has Pfizer received many calls about this, about the paperwork? It says it has not been approved, she would never have gotten it, it says only for emergencies, she doesn't have an emergency, this should have been given before the vaccination, it is probably still under clinical trial, but they are saying on TV everyone should be vaccinated, it is either up or down, yes or no, a see saw, yes they do something, then no, it's controversial, some part of paperwork says yes. Her breathing is not worse, this says it may go away in a few days, it says if it bothers you or does not go away, how long does she wait? It says severe reaction she doesn't understand, if it goes away, it doesn't bother her health, then goes away because of the vaccine inside, ok, once she got the vaccine, she had to stay in a room for 20 minutes or so, she had to stay in a room if she had a reaction. Her vaccine card says first dose, then says the hospital, she can't really read it, they write so quick. Says 11Feb2021 is her second dose She read in there, if you have an allergic reaction to other vaccines, she said no, this was her first reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/24/2021,3.0,UNK,,,,,,['Dyspnoea'],1,PFIZER\BIONTECH, 1056553,,,F,"diarrhea; This is a spontaneous report from a contactable consumer (patient's husband). A 66-year-old female patient (wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for covid-19 immunisation. Medical history and concomitant medications were not provided. In the morning of 26Jan2021, four and a half hour ago (unspecified time), the patient experienced diarrhea, she used the bathroom twice thus far. The reporting consumer asked if diarrhea was also reported as a side effect of the vaccine, if they recommend for her to consult a healthcare professional (HCP) at this stage. Outcome of the event was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/26/2021,,UNK,,,,,,['Diarrhoea'],1,PFIZER\BIONTECH, 1056554,MI,68.0,F,"a little tenderness on the injection site; diarrhea; nausea; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer reported for herself that she received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9261) at single dose on 24Jan2021 at 13:00 for COVID-19 immunisation. Relevant history included thyroid removal on 11Sep2019, and tumor removed from her appendix on May2020. Relevant family medical history was none. Concomitant Products included: Levothyroxinesince Sep2019 and Ongoing. FIBO tests in 2020 that were positive for Hydrogen FIBO. The patient experienced no symptoms by then except for a little tenderness on the injection site. On 26Jan2021, she experienced a sudden onset of diarrhea and nausea at 15:00. Treatment included Zofran. The patient stated that she did get the Vsafe contact but not today (26Jan2021). Outcome of event nausea was not resolved, outcome of other events was unknown. No emergency room required, no physician office visit. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/26/2021,2.0,PVT,LEVOTHYROXINE,,Medical History/Concurrent Conditions: Appendectomy; Thyroidectomy,,,"['Diarrhoea', 'Investigation', 'Nausea', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1056555,NC,66.0,F,"headache; sweats; feverish; chills; low blood sugar symptoms; weakness; This is a spontaneous report from a contactable healthcare professional. This 66-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot EL3247) on 24Jan2021 at 11:15 AM at left arm for COVID-19 immunization in hospital. Historical vaccine included first dose for BNT162B2 (lot EK5730) on 02Jan2021 at 11:30 AM at left arm for COVID-19 immunization. Medical history included hypo thyroid, parox afib, high blood pressure (HBP), obesity and allergies: bupropion hydrochloride (WELLBUTRIN), soy. Concomitant drugs included metoprolol, apixaban (ELIQUIS), fluoxetine hydrochloride (PROZAC), losartan potassium (COZAAR), thyroid (ARMOUR THYROID) and more. On the day of injection on 24Jan2021 at 04:00 PM, the patient had low blood sugar symptoms, weakness, which resolved in a few hours. On second day, symptoms of low Blood sugar, sweats, feverish, chills, on third day feverish symptoms of low blood sugar, sweats, feverish, headache. No treatment was received. The outcome the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/24/2021,01/24/2021,0.0,PVT,ARMOUR THYROID; COZAAR; ELIQUIS; METOPROLOL; PROZAC,,Medical History/Concurrent Conditions: Hypertension; Hypothyroidism; Obesity; Paroxysmal atrial fibrillation; Soy allergy,,,"['Asthenia', 'Blood glucose decreased', 'Chills', 'Headache', 'Hyperhidrosis', 'Pyrexia']",2,PFIZER\BIONTECH, 1056556,NY,32.0,F,"Fatigue; Headache; fever (~100F); joint pain; chills; facial rash (flat, bright red rash on both cheeks and chin); This is a spontaneous report from a contactable consumer (patient). A 32-years-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL8982), via an unspecified route of administration on 24Jan2021 at 12:15 at single dose in left arm for COVID-19 immunisation. Medical history included depression and anxiety. Concomitant medication included sertraline and buspirone, both from unknown date for unknown indication. The patient experienced fatigue, headache, fever (~100f), joint pain, chills, facial rash (flat, bright red rash on both cheeks and chin), all on 24Jan2021 18:30 with outcome of recovering. No treatment was received. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. This case was reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/24/2021,0.0,UNK,SERTRALINE; BUSPIRONE,,Medical History/Concurrent Conditions: Anxiety; Depression,,,"['Arthralgia', 'Body temperature', 'Chills', 'Fatigue', 'Headache', 'Pyrexia', 'Rash']",1,PFIZER\BIONTECH, 1056557,,,F,"swelling/tingly on her right facial cheek; swelling/tingly on her right facial cheek; This is a spontaneous report from a contactable Other HCP (patient). This 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 21Jan2021 for COVID-19 immunisation. Medical history included rosacea. Concomitant medication was not reported. Patient received vaccine on Thursday and had been experiencing swelling/tingly on her right facial cheek. She saw both her PCP and dermatologist and has a history of rosacea. Her dermatologist told her to take cetirizine hydrochloride (ZYRTEC) for a week. Patient asked if this was a reported side effect, the efficacy after one dose; if could get second dose after having a reaction to the first vaccine; efficacy against other variants of the virus; information on rosacea/ autoimmune patients. The outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,,,UNK,,,Medical History/Concurrent Conditions: Rosacea,,,"['Paraesthesia', 'Swelling face']",UNK,PFIZER\BIONTECH, 1056558,OR,43.0,M,"Chills/shivers (first day); Mild fever (first day); Lymph node inflammation in neck (on and off since the vaccine); Headache; Arm pain at injection; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (lot number: EL3247), via an unspecified route of administration in left arm on 19Jan2021 13:00 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included cannabis. The patient experienced chills/shivers (first day), mild fever (first day), lymph node inflammation in neck (on and off since the vaccine), headache, and arm pain at injection on 19Jan2021 16:00. No treatment was received for these events. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,01/19/2021,0.0,UNK,CANNABIS,,,,,"['Chills', 'Headache', 'Lymphadenitis', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1056559,NY,51.0,F,"Body aches; Joint pains; Chills; Right arm injection muscular pain radiating to elbow; Slight nausea; Slight headache; Right arm injection muscular pain radiating to elbow; This is a spontaneous report from a contactable Nurse. This 51-year-old female Nurse (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3246), intramuscular at right arm on 25Jan2021 15:30 at single dose for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included HTN, cholesterol, known allergies: sulfa. Historical vaccine included the first dose of BNT162B2 (lot number=EJ1686) on 04Jan2021 13:00 via intramuscular at left arm for COVID-19 immunization. Concomitant medication included amlodipine, rosuvastatin calcium (CRESTOR), clonazepam. On 26Jan2021 12:00, patient had body aches, joint pains, chills, right arm injection muscular pain radiating to elbow, slight nausea, slight headache with outcome of unknown. No treatment was received. The patient underwent lab tests included COVID-19 virus test (nasal swab): negative on 10Jan2021. Patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/26/2021,1.0,PVT,AMLODIPINE; CRESTOR; CLONAZEPAM,,Medical History/Concurrent Conditions: Blood cholesterol abnormal; Hypertension; Sulfonamide allergy,,,"['Arthralgia', 'Chills', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'SARS-CoV-2 test', 'Vaccination site pain']",2,PFIZER\BIONTECH,OT 1056560,WV,75.0,M,"diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received his 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261) at single dose on 22Jan2021 about 14:40 intramuscular in right shoulder for COVID-19 vaccination. Medical history, concomitant drugs, and family medical history relevant to event were reported as ""none"". Patient had no history of all previous immunization with the Pfizer vaccine considered as suspect, no additional Vaccines Administered on Same Date of the Pfizer Suspect, no prior vaccinations (within 4 weeks), no relevant tests. Patient experienced diarrhea at about 8-9am 25Jan2021. Patient reported that he had had diarrhea for the last 24 hours (as of 26Jan2021). It started on 25Jan2021. Patient stated that his diarrhea did not go away. Usually he would go to the bathroom 3-4 times and it would go away, but this was not going away. No investigation assessment performed. The event did not require a visit to Emergency Room/ Physician Office. Outcome of the event was not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/25/2021,3.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Diarrhoea'],1,PFIZER\BIONTECH,OT 1056561,TX,43.0,F,"Neck/back chest pain; Neck/back chest pain; Neck/back chest pain; dizzy; weak; fever; This is a spontaneous report from a contactable nurse (the patient). This 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), dose 2, single dose via an unspecified route of administration in the left arm on 26Jan2021 at 10:00 AM (at the age of 43- years-old) for COVID-19 vaccination. The patient's medical history included hypertension, hyperlidemia, pre-cancer cells in cervix, hysterectomy and allergy to penicillin. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ELO1423, expiration: 1/2021), single dose, dose 1 in the right arm on 05Jan2021 at 10:00 AM. Concomitant medications included atorvastatin, hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), fluoxetine (PROZAC) and zolpidem (AMBIEN). On 27Jan2021, the patient had neck, back and chest pain, dizzy, weak and fever. The events were reported as non-serious. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. No therapeutic measures were taken as a result of neck, back and chest pain, dizzy, weak and fever. The clinical outcome of neck, back and chest pain, dizzy, weak and fever was not recovered . The patient has been tested for COVID-19 since having the vaccine. On 25Jan2021, COVID rapid test was negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,SEN,ATORVASTATIN; LOSARTAN/HCTZ; PROZAC; AMBIEN,,Medical History/Concurrent Conditions: Cervical cancer; Hyperlipidemia; Hypertension; Hysterectomy; Penicillin allergy,,,"['Asthenia', 'Back pain', 'Chest pain', 'Dizziness', 'Neck pain', 'Pyrexia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1056562,MD,50.0,M,"That night at 1:30 am started getting very nauseous and started vomiting. All of the next day I was extremely nauseous and unable to eat anything. I vomited up stomach acid. I have been taking Zofran; That night at 1:30 am started getting very nauseous and started vomiting. All of the next day I was extremely nauseous and unable to eat anything. I vomited up stomach acid. I have been taking Zofran; That night at 1:30 am started getting very nauseous and started vomiting. All of the next day I was extremely nauseous and unable to eat anything. I vomited up stomach acid. I have been taking Zofran; This is a spontaneous report from a contactable other healthcare professional (the patient).This 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), dose 2, single dose via an unspecified route of administration in the left arm on 25Jan2021 at 09:00 AM for COVID-19 vaccination. The patient's medical history included type 2 diabetic. The patient had no allergies to medications, food, or other products. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK4176), single dose, dose 1 in the left arm on 07Jan2021 at 12:00 PM. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 26Jan2021 at 1:30 AM, he started getting very nauseous and started vomiting. All of the next day, he was extremely nauseous and unable to eat anything. He vomited up stomach acid. He took ondansetron (ZOFRAN) for the nausea. It is now two days later and the nausea is better but still can't work or eat. The events were reported as non-serious. Therapeutic measures taken as a result of nausea included ondansetron (ZOFRAN). The clinical outcome of nauseous, vomiting and unable to eat was recovering. The patient has not been tested for COVID-19 since having the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,WRK,,,Medical History/Concurrent Conditions: Diabetic (Type 2 diabetic),,,"['Antibody test', 'Feeding disorder', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH, 1056563,MN,36.0,F,"1st dose: 24 hrs after administration, I developed a searing migraine that lasted for approx 15 hours. No medications could touch the pain and it felt like my brain and eyeballs were going to explore; 1st dose: 24 hours after administration, I developed a searing migraine that lasted for approx 15 hours. No medications could touch the pain and it felt like my brain and eyeballs were going to explor; 1st dose: 24 hours after administration, I developed a searing migraine that lasted for approx 15 hours. No medications could touch the pain and it felt like my brain and eyeballs were going to explor; This is a spontaneous report from a contactable self-reporting other health professional. A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686), intramuscularly on an unspecified date in Jan2021 at 13:00 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included anaphylactic reactions to penicillin and pistachios. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was administered to the patient in a hospital. The patient reported that twenty-four hours after administration she developed a searing migraine that lasted for approximately fifteen hours. She stated that ""no medications could touch the pain"" and it felt like her brain and eyeballs were going to explode. The patient specified that she did not receive any treatment for the events. The clinical outcomes of migraine, sensation of pressure and eye discomfort were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Anaphylaxis (penicillin and pistachios: both causing anaphylaxis); Food allergy (penicillin and pistachios: both causing anaphylaxis),,,"['Discomfort', 'Migraine', 'Ocular discomfort']",1,PFIZER\BIONTECH,OT 1056564,MI,91.0,F,"diarrhea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 at 11:45 (at the age of 91-years-old) as a single dose in the left arm for COVID-19 immunization (tired of being cooped up in the house). Medical history included atrial fibrillation and patient had a pacemaker, both from an unknown date. Concomitant medications were not reported. The patient did not receive other vaccines within four weeks prior to vaccination. On 25Jan2021, at night, the patient experienced diarrhea and vomiting. The clinical outcome of the events diarrhea and vomiting was recovered on 26Jan2021 at 02:00 and she felt good. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/25/2021,5.0,OTH,,,Medical History/Concurrent Conditions: Atrial fibrillation; Pacemaker insertion (cardiac) (Pacemaker),,,"['Diarrhoea', 'Vomiting']",1,PFIZER\BIONTECH, 1056565,NJ,53.0,F,"Left arm very sore up through left neck; Left arm very sore up through left neck; This is a spontaneous report from a contactable consumer (patient). This 53-year-old non-pregnant female patient received the first dose of BNT12B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unknown route of administration in the left arm on 26Jan2021 (at the age of 53-years-old) at 3:30 PM as a single dose for COVID-19 immunization. The patient's medical history included hypertension and penicillin allergy, both from unknown dates and unknown if ongoing. The patient's concomitant medications included hydrochlorothiazide, valsartan (DIOVAN HCT) from an unknown date for an unknown indication; amlodipine from an unknown date for an unknown indication; fish oil from an unknown date for an unknown indication; and vitamin B complex (VITAMIN B 50) from an unknown date for an unknown indication. The patient previously took levofloxacin (LEVOQUIN) on an unknown date for an unknown indication and experienced allergies; and influenza vaccine on an unknown date for an unknown indication and experienced pain. The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient reported experiencing left arm very sore up through left neck; not red just aching and pain through the first night post injection. The patient reported being still sore on day two; much more pain than flu shot previous experience. The event was reported as non-serious and did not require hospitalization. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen. The clinical outcomes of left arm very sore up through left neck were recovering. It was also reported the patient was not diagnosed with COVID-19 prior to vaccination and that the patient had not been tested for COVID-19 since vaccination. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,SCH,DIOVAN HCT; AMLODIPINE; FISH OIL; VITAMIN B 50,,Medical History/Concurrent Conditions: Hypertension; Penicillin allergy,,,"['Neck pain', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1056566,MO,31.0,M,"Sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (left arm) on 26Jan2021 09:00 (at the age of 31years) at single dose for Covid-19 immunization. The patient's medical history included Covid-19 (prior to vaccination the patient diagnosed with COVID-19). Concomitant medications included cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE); both from an unspecified date for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 07:00, the patient experienced sore arm at injection site. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was recovering. This case is non-serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,WRK,ZYRTEC; FLONASE,,Medical History/Concurrent Conditions: COVID-19 (prior to vaccination the patient diagnosed with COVID-19),,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1056567,MI,28.0,F,"Fever; Chills; Muscle aches; Swollen PAINFUL lymph nodes left armpit; Swollen PAINFUL lymph nodes left armpit; tingling left wrist; headache; fatigue; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: el9261) via an unspecified route of administration on the left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included drospirenone, ethinylestradiol (NIKKI) for birth control. The patient previously received first dose of BNT162B2 on 04Jan2021 for COVID-19 immunization (lot number: ej1685, left arm, 02:00 PM). On 26Jan2021 04:00 AM, the patient experienced fever, chills, Muscle aches, swollen painful lymph nodes left armpit, tingling left wrist, headache, fatigue. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Post vaccination, the patient has been tested for COVID-19, nasal swab on 25Jan2021: pending result. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. The facility where the vaccine was administered was in a Public Health Clinic/Veterans Administration facility. Outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,PUB,NIKKI,,,,,"['Chills', 'Fatigue', 'Headache', 'Lymph node pain', 'Lymphadenopathy', 'Myalgia', 'Paraesthesia', 'Pyrexia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1056568,FL,77.0,F,"felt a little dizzy / If she moves too quick she is light headed; Her equilibrium is off; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL9263, first dose) solution for injection intramuscular in the right arm on 26Jan2021 (at the age of 77-years-old) as a single dose for COVID-19 vaccination. There was no medical history. Concomitant medication included lisinopril for blood pressure. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient felt a little dizzy if she bends down / if she moves too quick she is lightheaded and her equilibrium was off on 27Jan2021. There was no emergency room or physician office. The outcome of the events dizziness and equilibrium loss was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,OTH,LISINOPRIL,,,,,"['Balance disorder', 'Dizziness']",1,PFIZER\BIONTECH,OT 1056569,AR,76.0,M,"18-20 hours after receiving the injection he noticed that ""his heart would beat ""hard""/heart beating fast; about 18 to 20 hours later the next morning he was experiencing something like a palpitation; arm hurt that night and the next morning/sore arm of course; This is a spontaneous report from a contactable consumer (patients wife). A 76-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9261) , via an unspecified route of administration on 21Jan2021 at 14:30 (at the age of 76-years-old) in the left arm as SINGLE DOSE for covid-19 vaccination. Medical history included cardiac murmur and Type 2 Diabetic. There were no concomitant medications. On 21Jan2021 the patient experienced arm hurt that night and the next morning/sore arm, and On 22Jan2021, 18-20 hours after receiving the injection he noticed that 'his heart would beat hard' /heart beating fast/he was experiencing something like a palpitation. Report described that it is like when you get scared. This Happens 2-3 times a day and it is not constant. The patient went to his primary care physician on Friday for a 'routinely scheduled annual check up' and mentioned this to her at his appointment. His provider encouraged him to call Pfizer and report these symptoms. His doctor is going to continue to follow up with him and if the problem persists do further tests. Lab data included heart rate on 22Jan2021 18-20 hours after injection his heart would beat hard /would be fast/something like a palpitation. The clinical outcome of heart beating fast was not recovered while palpitations and arm pain were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Heart murmur (Verbatim: Heart murmur); Type 2 diabetes mellitus (Verbatim: Type 2 Diabetic),,,"['Heart rate', 'Heart rate increased', 'Pain in extremity', 'Palpitations']",1,PFIZER\BIONTECH, 1056570,TX,83.0,F,"itching and rash on her face which turned it very red; itching and rash on her face which turned it very red; itching and rash on her face which turned it very red; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL9262, expiry date unknown), via an unspecified route of administration, on 20Jan2021, at a single dose for COVID-19 immunization. Medical history included ongoing allergies (She normally gets an allergy shot for mold and stuff. She had one 8 days prior to getting the vaccine. She has not gotten one since. She is due but she cannot get it until this clears up. She is unsure of the name of the allergy shot that she gets. She had all the allergy tests years ago and has been going for the last 4 years or so. For things like mold, dust, cockroaches, grass, and trees) for which receiving allergy shot, ongoing High blood pressure, ongoing Reflux, and ongoing Osteoporosis/osteopenia. Osteoporosis runs in her family, she does not have it yet but she had Osteopenia (She started young). Concomitant medications included Allergy shot (unspecified) for about 4 years for allergies, valsartan (Started about 5 or 6 years ago) orally at 160 mg, twice a day for high blood pressure, amlodipine (Started about 5 or 6 years ago), orally at 2.5 mg, once a day for High blood pressure, lansoprazole (PREVACID) (Started about 15-20 years ago) orally at 15 mg once a day for Reflux and ibandronate sodium (started about 10 years ago) via an unknown route, at 150 mg once a month for Osteoporosis/osteopenia; all were ongoing. Patient had the first shot of the vaccine last Tuesday. She stayed for half an hour and was fine. She left there and 10 minutes later while driving she started getting itchy around her face mask. She thought it was the mask irritating her skin. As the day progressed her cheeks and under her chin were getting red and itchy. She took Benadryl and the next day it got worse. She called the doctor and they put her on 20mg Prednisone two times a day. That was a week ago Tuesday. She called her allergist and he thought it was the poly glycol peg that is in the vaccine. He will test her after it is all out of her system. Both her regular doctor and her allergist told her not to take the second shot because it was too close a situation. She did not have an anaphylactic reaction, but if she had not jumped on it right away what could have happened. She is wondering if company has any data on the efficacy of the first shot if going on Prednisone right after? She started the Prednisone the next night. She is tapering off now. She still has a little bit of heat on her face and itching under the skin. So, apparently, she had an allergy to the vaccine and was told not to get the second shot. Patient clarified that she did not get the vaccine last Tuesday. She got the vaccine last Wednesday which was 20Jan2021. She said the reaction started about 40-45 minutes after receiving the dose. She has improved about 90% since starting the Prednisone. This morning her face is a little red. She is currently weaning off the Prednisone. Her face was red and it feels a little hot. She is down to 10mg twice a day. She had started the Prednisone the next day on 21Jan2021. She started the wean yesterday. This morning her face is a littler red on her cheeks. The vaccine seems to be taking a long time to get out of her system. NDC, lot, exp are unknown for the Prednisone as it is in a pharmacy vial. Her doctor told her to stop taking Benadryl as it does not stay in the system long enough. She says the Benadryl is not in a bottle, it is in a stupid little package. LOT: SMF001. EXP: May2022. Her doctor put her on Zyrtec twice a day instead. She started that on 25Jan2021. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,UNK,VALSARTAN; AMLODIPINE; PREVACID; IBANDRONATE SODIUM,Allergy; Blood pressure high; Osteoporosis; Reflux gastritis,,,,"['Erythema', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH, 1056571,IL,53.0,F,"Fever of 101; body aches like the flu; headache; like the flu; This is a spontaneous report from a contactable health care professional, the patient. A 53-years-old female non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK 9231), via an unspecified route of administration in the right arm on 25Jan2021 at 14:30 (at the age of 53-years-old) as a single dose, for COVID-19 vaccination. Facility where the most COVID-19 vaccine was administered was a Nursing Home/Senior Living Facility. Medical history included breast cancer on an unspecified date (Breast cancer survivor) and Covid-19 on an unspecified date (Prior to vaccination, the patient was diagnosed with COVID-19). Concomitant medication included escitalopram oxalate (LEXAPRO), tamoxifen (TAMOXIFEN). The patient had no known allergies. No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19. On 26Jan2021, The patient experienced fever of 101, body aches, like the flu, headache. The events were considered non serious. The patient underwent lab tests and procedures which included body temperature:101 fahrenheit (fever 101) on 26Jan2021. No treatment was given for the events. The clinical outcome of the events Fever of 101, body aches like the flu, headache was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,SEN,LEXAPRO; TAMOXIFEN,,"Medical History/Concurrent Conditions: Breast cancer (Breast cancer survivor); COVID-19 ((Prior to vaccination,the patient was diagnosed with COVID-19).)",,,"['Body temperature', 'Headache', 'Influenza', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 1056572,CO,71.0,M,"diarrhea; He supposed that he is dehydrated; nausea; feeling unwell; chills; This is a spontaneous report from a contactable consumer (patient). A 71-years-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL3246 , unspecified route of administration on 21Jan2021 13:10 (at the age of 71-years old) as a SINGLE DOSE given in left arm for COVID-19 vaccination. Medical history included ongoing vertigo, ongoing dizziness, ongoing balance problems, ongoing vision problems, ongoing stomach problems, he lost 80lbs in a year, but his weight is starting to go back up. He has had bad health for the last 3 years. He goes to the doctors all the time. In fact, he just went to the ear, nose and throat (ENT) to find out what was going on. He has had dizziness quite often, so there are days where he just don't feel good but, he thinks it has something to do with his eyes. When he feels bad, he will lay down and close his eyes, and all of his problems go away. He went to see a retina specialist because of his continuing vision problems. The ENT doctor told him he can't help him. Concomitant medications included 6 different medications. The patient experienced side effects after getting the first dose of the vaccine. He got the first dose a week ago and he said that he experienced nausea, feeling unwell, chills and diarrhea. The patient experienced nausea, feeling unwell, chills in Jan2021 and diarrhea on 26Jan2021. He had his shot a week ago tomorrow. He was up all night last night with diarrhea, he was up probably up 10 times. He was supposed to go in to get his teeth pulled today, but he just can't do it. He does have some chills and nausea. He is feeling unwell. He supposed that he is dehydrated in Jan2021. The diarrhea just started last night, 26Jan2021. He got up about 6:15 this morning and that was the last time he had diarrhea. He still has nausea, but he hasn't had any other diarrhea. He has some nausea from the time to time. He doesn't have any COVID symptoms that he can tell. He is feeling unwell, and has the nausea and chills, but he does not have any fever. He hasn't had a fever and he can still smell and taste and all of that stuff. One thing he did notice after he got his COVID-19 shot was that he did not have any symptoms of any kind. He never had pain in his arm, nothing. He received the vaccine on 21Jan2021, and he never felt a thing or anything that would associate with the shot. The consumer doesn't know if what he is going through is caused by the shot or not. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/01/2021,,UNK,,Balance disorder; Dizziness; Stomach upset; Vertigo; Vision abnormal,Medical History/Concurrent Conditions: Weight fluctuation,,,"['Chills', 'Dehydration', 'Diarrhoea', 'Malaise', 'Nausea']",1,PFIZER\BIONTECH, 1056573,NY,25.0,F,"The next day I felt intense lethargy; Soreness of the injection site; Dizzy; Light-headed/ Light headedness; Intense chills; Shaking; Feverish; Nausea; Body aches; This 25- year-old female patient contactable other HCP (reported for herself) received the second dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME)(lot EL3247; expiration not provided), via an unspecified route of administration, on 25Jan2021 at 10:00 AM (at the age of 25-years-old) as a single dose for COVID-19 immunization. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. Patient is not pregnant. The patient received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME)(lot EL0142; expiration not provided), via an unspecified route of administration, on 04Jan2021 at 11:00 AM (at the age of 25-years-old) as a single dose for COVID-19 immunization. Medical history included: allergies to: Azithromicin, raw fruit (apples, peaches, pears, plums, cherries, apricot). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Jan2021 at 11:00pm, she reported ""Within the first 15 min I felt dizzy and light-headed, that subsided after that. Around 12hours later I had intense chills, shaking, feverish, nausea and body aches. This lasted for around 5 hours, no medication was taken to treat. The next day I felt intense lethargy and light-headedness. The day after the lethargy continued with body-aches and continued soreness of the injection site"" The clinical outcome of the events dizzy, light-headed, intense chills, shaking, feverish, nausea was recovering; the outcome of the events lethargy, body-aches, continued soreness of the injection site was not recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Fruit allergy,,,"['Chills', 'Dizziness', 'Lethargy', 'Nausea', 'Pain', 'Pyrexia', 'Tremor', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1056574,,,F,"After she got the vaccine this pain in her knee increased; sore arm; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unspecified date in Jan2021(at an unknown age) as a single dose for COVID-19 vaccination. Medical history was reported as arthritis, hip and knee pain which she attributed to the cold weather. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown) on an unspecified date for COVID-19 immunization. Concomitant medications were not provided. The reporter stated that, on an unspecified date in Jan2021 (reported as ""last Monday"") she got the second dose of ""the COVID shot."" Prior to this she had arthritis and hip and knee pain which she attributed to the cold weather. After she got the vaccine this pain in her knee increased and she also experienced a sore arm which went away two days after. The clinical outcomes of knee pain increased was reported as unknown. The clinical outcome of sore arm was reported as resolved on an unspecified date in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Arthritis; Knee pain; Pain in hip; Sensitivity to weather change,,,"['Arthralgia', 'Pain in extremity']",2,PFIZER\BIONTECH, 1056575,NC,27.0,F,"intense upper stomach pains (difficult time bending over, etc); Difficult time breathing/shortness of breath; This is a spontaneous report from a contactable healthcare professional. This 27-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3247) intramuscularly in the left arm on 25Jan2021 (at the age of 27-years-old) at 09:00 as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medication included escitalopram oxalate (LEXAPRO) from an unknown date for an unknown indication, dicyclomine from an unknown date for an unknown indication, doxycycline from an unknown date for an unknown indication, levothyroxine from an unknown date for an unknown indication, birth control from an unknown date for an unknown indication and women's multivitamins from an unknown date for an unknown indication. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 26Jan2021 at 08:00 the patient experienced intense upper stomach pains (difficult time bending over, etc.). Additionally, she experienced a difficult time breathing/shortness of breath. The patient reported the events resulted in an emergency room or urgent care visit. It was unknown if the patient received treatment for the events. The clinical outcomes of intense upper stomach pains (difficult time bending over, etc.) and a difficult time breathing/shortness of breath were recovering. It was also reported that since the vaccination the patient had tested negative for COVID-19 on 26Jan2021 via nasal swab and polymerase chain reaction tests.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,PUB,LEXAPRO; DICYCLOMINE; DOXYCYCLINE; LEVOTHYROXINE,,,,,"['Abdominal pain upper', 'Dyspnoea', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1056576,NC,67.0,F,"sinus infection; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date was unspecified) via an unspecified route of administration on 23Jan2021 (at the age of 67 years old) in a single dose for COVID-19 immunisation. No Medical history or concomitant medication reported. The patient experienced sinus infection on an unspecified date. The patient was prescribed Cefdinir 300mg, twice daily and Methylprednisolone 4mg once daily for 7days. The patient wanted to check about the medications that her doctor has given her for the sinus infection to see if it will override the effects of the COVID vaccine. Outcome of event sinus infection was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,,,UNK,,,,,,['Sinusitis'],1,PFIZER\BIONTECH, 1056577,GA,,F,"headache/ headachy; muscle aches; sore throat; sore arm; I felt worse; fever of 99.8; just felt overall very sick - flulike; just felt overall very sick - flulike; remaining very fatigued and slightly headachy; This is a spontaneous report from a contactable nurse (patient). This 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL8982; dose 2) intramuscularly on 26Jan2021 at 13:00 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included prolactinoma and osteoporosis. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior of the vaccine. The patient did not have COVID-19 prior to vaccination. Concomitant medications included vitamin D3 and bromocriptine (PARLODEL) from unknown dates for unknown indications. The patient had no known allergies. The patient previously received BNT162B2 (dose 1; lot number EL0142; left arm) on 05Jan2021 at 13:00. The patient felt fine until 26Jan2021 at 22:00- bedtime. She woke up during the night with a headache, muscle aches, sore throat, and sore arm. She tried to sleep it off but when she awoke at 07:00 she felt worse and had a fever of 99.8 and felt overall very sick- flulike. The patient was treated with ibuprofen. The patient started feeling better by about 14:00 ""the next day"" (unspecified) although she remained very fatigued and slightly ""headachy."" The clinical outcomes of headache, muscle aches, sore throat, sore arm, fever, flulike symptoms, and fatigue were recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/27/2021,1.0,WRK,PARLODEL; VITAMIN D3,,Medical History/Concurrent Conditions: Osteoporosis; Prolactinoma,,,"['Body temperature', 'Condition aggravated', 'Fatigue', 'Headache', 'Illness', 'Influenza like illness', 'Myalgia', 'Oropharyngeal pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,OT 1056578,IL,60.0,M,"Loss of taste; right kidney pain severe; injection site pain; This is a spontaneous report from a contactable consumer (patient). This 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; dose 1) via an unspecified route of administration on 25Jan2021 at 10:00 (at the age of 60-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included chronic back pain, scoliosis, kidney stones, 3 double hernias, venous deficiency, fibromyalgia, 2 torn ligaments right foot, diabetes, and diabetic neuropathy. The patient did not receive any other vaccines within four weeks prior to the vaccine. The patient did not have COVID-19 prior to vaccination. The patient received unspecified concomitant medications. The patient previously took morphine from an unknown date for an unspecified indication and experienced allergy. On 25Jan2021 at 10:15 the patient experienced loss of taste, right kidney pain severe, and injection site pain. The patient was not treated for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,SEN,,,Medical History/Concurrent Conditions: Chronic back pain; Diabetes; Diabetic neuropathy; Fibromyalgia; Hernia (3 double hernias); Kidney stones; Ligament tear (2 torn ligaments right foot); Scoliosis; Venous insufficiency,,,"['Ageusia', 'Renal pain', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1056579,MO,40.0,M,"Lathargic; headache; muscle ache; chills; This is a spontaneous report from a contactable consumer (Patient). A 40-year-old male patient received first dose of BNT162B2 (COVID 19, Pfizer/BionTech, Solution for injection, Lot number: EN5318), via an unknown route administration on 26Jan2021 12:00 on left arm at single dose for Covid-19 immunization at Workplace clinic. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products was reported. Concomitant medications the patient received within 2 weeks of vaccination included bupropion (buproprion), buprenorphine hydrochloride (SUBUTEX) and trazodone (trazadone). On 26Jan2021 at 18:00, the patient experienced lathargic, headache, muscle ache, chills. No treatment was received for the events. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Outcome of events at the time of last observation was recovering. Information regarding lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,WRK,BUPROPION; SUBUTEX; TRAZODONE,,,,,"['Chills', 'Headache', 'Lethargy', 'Myalgia']",1,PFIZER\BIONTECH, 1056580,KS,63.0,F,"got dizzy; felt queasy; Temp was lightly elevated; Sore injection site; Could not sleep, very uncomfortable.; Got hot and sweaty about 3 1/2 hours after shot.; Got hot and sweaty about 3 1/2 hours after shot.; administration_date=26Jan2021; other vaccine date = 26Jan2021; administration_date=26Jan2021; other vaccine date = 26Jan2021; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unknown route of administration on left arm (L shoulder/Arm) on 26Jan2021 at 09:00 AM at the age of 63 years old at a single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included RA (Rheumatoid arthritis), Penicillin allergy and covid-19 (The patient was diagnosed with COVID-19 prior to vaccination). Concomitant medications included leflunomide (ARAVA) at 20mg, once a day, daily vitamins and mesalamine 1/day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Also reported administration date 26Jan2021; other vaccine date 26Jan2021. On 26Jan2021 09:00, the patient experienced sore injection site (shot was given very high on L shoulder/Arm). Felt like a sharp pain when given. Got hot and sweaty about 3 and an half hours after shot. Could not sleep, very uncomfortable. Next morning (on 27Jan2021), the patient was getting ready to eat breakfast and got dizzy and felt queasy. Temp was lightly elevated. Taking Tylenol to help control soreness. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events administration_date=26Jan2021; other vaccine date = 26Jan2021 was unknown and patient was recovering from all other events. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,UNK,ARAVA; DAILY VITAMINS; MESALAMINE,,"Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?:Yes); Penicillin allergy; RA",,,"['Body temperature', 'Body temperature increased', 'Dizziness', 'Feeling hot', 'Hyperhidrosis', 'Insomnia', 'Nausea', 'Off label use', 'Product use issue', 'SARS-CoV-2 test', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 1056581,NJ,33.0,F,"sore arm for two days; This is a spontaneous report received from a non-contactable consumer (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in Jan2021 (lot number and expiry date unknown), at single dose; then received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm, in Jan2021 (lot number and expiry date unknown), at single dose, for covid-19 immunization, at the hospital. There were no medical history and concomitant medication. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive other vaccines in four weeks. The patient experienced sore arm for two days in Jan2021. Treatment included two doses of Advil. The patient recovered from the event in Jan2021. No follow-up attempts are possible; Information about lot and batch number could not be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1056582,NC,82.0,F,"throat tightening; discomfort; little swelling; This is a spontaneous report from a contactable consumer. An 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 26Jan2021 10:15 at single dose on Left arm for covid-19 immunisation. Medical history included has a lot of allergies, reactions to honey and penicillin, She experienced neck swelling after receiving penicillin. Caller took the 1st dose last 26Jan2021. she and her husband got the Covid-19 vaccine yesterday. While reporting on her husband, caller states she had a reaction to the vaccine. After receiving the shot, Caller was put on the side for half hour and 15 min later, she experienced her throat tightening on 26Jan2021. Caller was given Benadryl and observed for 10 min. Her husband received his shot but ""he did not feel the needle going into his arm. Weight is between 120-123lbs. Caller mentioned that she has a lot of allergies. They watched her for 30 minutes after getting the vaccine. Within 15 minutes her throat was feeling a little tight. It cleared after about 10 minutes. Her vital signs were checked and were fine. Thy also gave her some Benadryl. She takes vitamins and minerals because she believes in them. Outcome of the event throat tightening recovered on 26Jan2021 and events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,OTH,,,Medical History/Concurrent Conditions: Allergy; Food allergy; Neck swelling; Penicillin allergy (She experienced neck swelling after receiving penicillin),,,"['Discomfort', 'Swelling', 'Throat tightness', 'Vital signs measurement', 'Weight']",1,PFIZER\BIONTECH, 1056583,,28.0,F,"Hives all over from scalp to toes for over six days; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL9262), via an unspecified route of administration in left arm on 22Jan2021 14:30 at a single dose for COVID-19 immunisation. Medical history included allergies to Sulfa. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19 Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and ethinylestradiol, etonogestrel (NUVARING). The patient experienced hives all over from scalp to toes for over six days on 22Jan2021 22:30. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,UNK,WELLBUTRIN; NUVARING,,Medical History/Concurrent Conditions: Sulfonamide allergy (Allergies products: Sulfa),,,['Urticaria'],1,PFIZER\BIONTECH, 1056584,MO,52.0,M,"Soreness at injection site in arm lasting 2 days; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates unknown), via an unspecified route of administration on left arm, on 26Jan2021 at 08:30 AM, at a single dose for COVID-19 immunization at clinic. Medical history was not reported. Patient had no allergies to medications, food, or other products. Concomitant medications included sertraline hydrochloride (ZOLOFT), atorvastatin (LIPITOR) and amlodipine besilate (NORVASC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On an unknown date in Jan2021 at 09:30 AM, the patient experienced soreness at injection site in arm lasting 2 days. The patient assessed the event as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the event on an unspecified date in Jan2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/01/2021,,WRK,ZOLOFT; LIPITOR; NORVASC,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1056585,OH,89.0,M,"has a fever of 102; Caregiver tried to have him eat something but he took one bite said it did not taste quite right; slept most of the day/sleeping more than usual; This is a spontaneous report from a Pfizer Program. A contactable consumer reported that an 89-year-old male patient received first dose of bnt162b2 (Solution for injection) via unspecified route of administration on right arm at single dose on 23Jan2021, 14:00 (Saturday). The patient medical history included ongoing dementia (He has a little bit of dementia which has been ongoing since unknown date but at least 10 years) and Maybe some thyroid issues. The patient concomitant medication was not reported. On 27Jan2021, the patient slept most of the day/sleeping more than usual, caregiver tried to have him eat something, but he took one bite said it did not taste quite right and had a running fever of 102 degrees Fahrenheit. It was reported that patient usually wakes up around 9:00 to 9:30 and read his book but on 27Jan2021 he has been in his chair and slept most of the day, about 3-4 hours until around 14:00 to 14:30. The caregiver gave him some Tylenol and he was reading again with events ongoing and persistent. The reporter enquired whether these events were normal after vaccination because he would have had the symptoms onset closer to the date of vaccination. Therapeutic measures were taken for fever. The outcome of the events was not recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/27/2021,4.0,PUB,,Dementia (He has a little bit of dementia which has been ongoing since unknown date but at least 10 years),Medical History/Concurrent Conditions: Thyroid disorder,,,"['Body temperature', 'Pyrexia', 'Somnolence', 'Taste disorder']",1,PFIZER\BIONTECH, 1056586,,,M,"arm got swollen; says its ""hurting like the dickens"" and ""can't pick up nothing.""; says its ""hurting like the dickens"" and ""can't pick up nothing.""; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm got swollen, says its ""hurting like the dickens"" and can't pick up nothing. Patient was asking if there was anything he can do. Outcome of events was unknown. Information on lot/batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,,,UNK,,,,,,"['Mobility decreased', 'Pain in extremity', 'Peripheral swelling']",UNK,PFIZER\BIONTECH, 1056587,CO,77.0,M,"Arm is very sore; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration in left arm on 27Jan2021 10:00 at a single dose for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included metformin. The patient experienced arm is very sore on 27Jan2021. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,PUB,METFORMIN,,,,,['Pain in extremity'],2,PFIZER\BIONTECH, 1056588,WA,,F,"her arm is a little bit sore; This is a spontaneous report from a Pfizer sponsored program. A Contactable consumer (Patient) reported that a female patient of an unspecified age receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at single dose for covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. Concomitant Therapy included physical therapy session today on 26Jan2021. The patient had the vaccine last night (25Jan2021) and had a physical therapy session today, she also mentioned she's not experiencing any adverse event but mentioned that her arm was a little bit sore on an unknown date in Jan2021. The outcome of the event was unknown. Information on the Lot/Batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/01/2021,,UNK,,,,,,['Pain in extremity'],UNK,PFIZER\BIONTECH, 1056589,NY,72.0,M,"room, surroundings spinning; nausea; vomiting; dizziness; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3247, expiration date unknown), via an unspecified route of administration on left arm on 19Jan2021 13:30 at a single dose for COVID-19 immunisation in facility type other. The patient's medical history included high BP (blood pressure), high cholesterol. The patient was not aware of any allergies to medications, food, or other products. Concomitant medications included lisinopril, simvastatin, cyanocobalamin (VIT B12), ASA at 81 mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. It was reported that, 2.5 days (on 22Jan2021 01:00 AM) after vaccination, patient experienced dizziness. Noted during the night. More pronounced when lying on his right side. Dizziness continues on and off, even during the daytime. No weakness or unsteady gait noted. Dizziness led to nausea and vomiting yesterday 27Jan2021. Patient felt a bit better this morning around 5 AM but dizziness persists. Room, surroundings spinning. Patient spoke with his primary physician yesterday, he suggested vestibular physical therapy. Patient do not think this was the issue. Patient took an over the counter dramine tablet this morning for nausea and vomiting. The events were considered as non-serious by patient. The patient was recovering from the events nausea, vomiting and patient was not recovered from the other events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/22/2021,3.0,UNK,LISINOPRIL; SIMVASTATIN; VIT B12; ASA,,Medical History/Concurrent Conditions: Blood pressure high; High cholesterol,,,"['Dizziness', 'Nausea', 'Vertigo', 'Vomiting']",1,PFIZER\BIONTECH, 1056590,TX,28.0,F,"Fever; chills; body aches; fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date: unknown), intramuscular on the right arm, on 28Jan2021 07:30, at SINGLE DOSE for covid-19 immunisation, at the workplace clinic. Medical history included asthma, allergies and COVID-19 (prior to vaccination). The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 28Jan2021 at 20:00, the patient experienced fever, chills, body aches and fatigue. The patient was not tested for COVID-19 since the vaccination. No treatment was received for the events. The outcome of the events was recovering. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Allergy; Asthma; COVID-19 (Prior to vaccination),,,"['Body temperature', 'Chills', 'Fatigue', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,OT 1056591,MO,,F,"Fever with temperature of 102.2 degrees F; Chills; Headache; Nausea; Body ache; This is a spontaneous report from a contactable consumer reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Jan2021 15:50 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever with temperature of 102.2 degrees F, chills, headache, nausea and body ache in Jan2021. Outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/01/2021,,UNK,,,,,,"['Body temperature', 'Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 1056592,GA,,F,"Broke out in Hives on my arms legs and my thighs on the 3 day; extreme itching; Had no problems a little sore arm; This is a spontaneous report from a contactable Consumer (Patient). An 68-year-old female non-pregnant patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EL0140, expiration date: Mar2021) via unspecified route of administration, on left arm, at 16:30 on 15Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medication included multi vitamins, Calcium, biotin and omeprazole. The patient had no problems a little sore arm on 15Jan2021. The patient reported 'she broke out in hives, it was on her arms, on her legs, her thighs on the 3 day evening (on 18Jan2021). Not really on the top of her body, not on her chest and also had extreme itching. Itching went away in about 12 hours. It was reported that hives returned days 4-9. The hives would go away and return. It was reported that when patient first time visited the local doctor the hives gone and by next morning it was completely gone and again appeared evening about the same time for seven days. The patient took pictures and finally visited local doctor. The doctor gave a shot of steroid injection (treatment) and prescribed Zyrtec and Pepcid and advised not to take second dose of vaccine. The patient reported that she never had a reaction to medications. The patient guessed that she was not going to be able to take the second vaccine and wanted to confirm it. It was reported that patient was very healthy and had no allergies. The patient had no COVID prior and post vaccination. The outcome of the event broke out in hives on my arms legs and my thighs on the 3 day was recovered on an unknown date in 2021; extreme itching was recovered on an unknown date in Jan2021 while for the event had no problems a little sore arm was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,PVT,CALCIUM; BIOTIN; OMEPRAZOLE,,,,,"['Pain in extremity', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH, 1056593,MI,,F,"headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (Patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknown date in Jan2021 at single dose for covid-19 immunization. The patient medical history was included osteoporosis. The patient's concomitant medications were not reported. After taking the first shot patient experienced painless and little headache on an unknown date in Jan2021. Patient wanted to know if a zoledronic acid (RECLAST) infusion will interfere with the Covid vaccine. She received the first dose of the vaccine on Sunday and was scheduled to receive a zoledronic acid (RECLAST) infusion for osteoporosis today at 2:30. The outcome of the event was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Osteoporosis,,,['Headache'],1,PFIZER\BIONTECH, 1056594,,,M,"tested positive; arm soreness; headache; minor chills; cough; This is a spontaneous report from a contactable consumer. A 24-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the left arm on 10Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked if he was eligible to get the second vaccine dose if he tested positive and had COVID. The patient reported that he got his first COVID vaccine dose on 10Jan2021 and experienced arm soreness, headache and minor chills the day after getting the vaccine, on 11Jan2021. Then on Wednesday into Thursday, he began having a cough which prompted him to get tested and he tested positive on Thursday 14Jan2021. The patient underwent lab tests and procedures which included COVID test: positive on 14Jan2021. Outcome of the events was unknown. Information of lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,01/10/2021,0.0,UNK,,,,,,"['Chills', 'Cough', 'Headache', 'Pain in extremity', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1056595,,,F,"high blood pressure of 209/101; general ""unwell"" feeling; This is a spontaneous report from a contactable consumer (granddaughter). An 85-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: Unknown), via an unspecified route of administration on 24Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. According to the consumer her grandmother received the first dose of bnt162b2 on 24Jan2021 and has experienced high blood pressure of 209/101 and a general 'unwell' feeling on an unspecified date. The outcome of the event general ""unwell"" feeling and high blood pressure of 209/101 was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/24/2021,,,UNK,,,,,,"['Blood pressure measurement', 'Hypertension', 'Malaise']",UNK,PFIZER\BIONTECH, 1056596,,,M,"headache; stiff neck; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (also reported as ""on Tuesday"") at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter's uncle (patient) experienced bad headache and stiff neck on an unspecified date. The outcome of the events was unknown. Information on the /batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Headache', 'Musculoskeletal stiffness']",UNK,PFIZER\BIONTECH, 1056597,,29.0,F,"Rigors; pain at injection site; body aches; This is a spontaneous report from a non-contactable nurse reporting for herself. A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 29-year-old via intramuscular in the left arm on 28Jan2021 01:00 PM at a single dose for COVID-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was not allergic to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient experienced rigors, pain at injection site, body aches on 29Jan2021 at 03:00 AM. No treatment was received for the events. The nurse considered the events as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/29/2021,1.0,PVT,,,,,,"['Chills', 'Pain', 'Vaccination site pain']",2,PFIZER\BIONTECH,OT 1056598,VA,,F,"feeling nervous; shaky body; feet felt very hot; This is a spontaneous report from a contactable consumer, the patient, received from the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 11Jan2021 (at an unspecified age) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Jan2021 (a week after vaccination), the patient experienced a shaky body, feeling nervous, and her feet felt very hot. The clinical outcome of a shaky body, feeling nervous, and her feet felt very hot was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/01/2021,,UNK,,,,,,"['Feeling hot', 'Nervousness', 'Tremor']",1,PFIZER\BIONTECH, 1056599,NC,77.0,F,"Felt jumpy on the injection site/right arm started jumping/""been jumping, jumpin jumpin jumpin"", a muscle twitch; Felt jumpy on the injection site/right arm started jumping/""been jumping, jumpin jumpin jumpin"", a muscle twitch; Arm is sore; Heart is pounding; I'm a little jittery. I am very nervous; I'm a little jittery. I am very nervous; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported), intramuscularly on the right arm on 27Jan2021 (10:00) at a single dose for COVID-19 immunization at the school/student health clinic. Medical history included diabetes diagnosed about 12 years ago; high blood pressure diagnosed about 30 or 40 years ago; and weight loss. Concomitant medication included insulin (INSULIN) for diabetes. The patient previously took influenza vaccine, sitagliptin phosphate (JANUVIA) and tramadol (ZALDIAR); and had rash on both medications. The patient had previously received a flu shot around the 6th or 7th of Dec2020. On 27Jan2021, at ""about 4PM"", the patient had felt jumpy on the injection site/right arm started jumping; it had ""been jumping, jumpin jumpin jumpin, a muscle twitch"". Also on 27Jan2021, at ""about 4PM"", the patient's arm was sore; heart was pounding; was a little jittery; and was very nervous. The outcome of the events, 'felt jumpy on the injection site/right arm started jumping', 'had ""been jumping, jumpin jumpin jumpin, a muscle twitch""', 'arm was sore', 'heart was pounding', 'little jittery' and 'very nervous', was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,SCH,INSULIN,,Medical History/Concurrent Conditions: Blood pressure high (diagnosed about 30 or 40 years ago); Diabetes (diagnosed about 12 years ago); Weight loss,,,"['Feeling jittery', 'Muscle twitching', 'Nervousness', 'Pain in extremity', 'Palpitations', 'Vaccination site reaction']",1,PFIZER\BIONTECH,OT 1056600,,,F,"fever; chills; body aches; This is a spontaneous report from a contactable other healthcare professional via a sales representative. A female patient of an unspecified age received 2nd dose of BNT162B2 (Pfizer-BionTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 FOR COVID-19 immunisation. Patient explained that after receiving her second dose of the vaccine she experienced 3 days of fever, chills and body aches on an unspecified date. The outcome of events was unknown. No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1056601,CO,73.0,F,"ran a fever of 101 degrees; lots of chills; sweating; dizziness; she was not quite herself; aching in her shoulder, into her back; aching in her shoulder, into her back; weak and unable to function; weak and unable to function; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), intramuscular on 16Jan2021 1:45 PM at a single dose on the left shoulder, right at the very top for COVID-19 immunization. Medical history included ongoing lupus since 1999. Concomitant medications reported were none. The patient experienced aching in her shoulder, into her back, dizziness, she was not quite herself on 16Jan2021; she ran a fever of 101 degrees, had lots of chills and sweating on 18Jan2021; she became weak and unable to function, and tired on an unspecified date in Jan2021. The patient stated she got the first dosage of the COVID-19 vaccine and had some side effects. She received the first COVID-19 vaccine on 16Jan2021. She had some aching in her shoulder and stuff on 16Jan2021. For 2 days, she was weak and unable to function. She ran a fever of 101 degrees on 18Jan2021 and was sweating head to toe. At the time of report, she currently had no fever, but was feeling very fatigued. She stated she is trying to make her next appointment, but she can't pull up the paperwork. She wants to know what to do about the side effects. Her next appointment on 13Feb2021. Her shoulder hurt an hour after she received the vaccine on 16Jan2021. That night and the next day, the whole shoulder even into her back started hurting. Like when she rolled over and laid down, she would say ""ohhh, I can't lay that way"". This lasted for a couple of days. Her shoulder is still tender, but it is much better. She can lift it up, move it around and it's not causing her any difficulty. She stated she became weak. The first night after receiving the vaccine in the middle of the night, she kind of had like a dizziness, she was not quite herself. She thought it was just part of the vaccine. The next day, she couldn't do anything. She was down for 2 days after that. On the 17Jan2021 and 18Jan2021, she was feeling really happy. On 18Jan2021, she started to have a fever. She had a fever that night and part of the next day. She had lots of chills. The fever and chills have seemed to go away. She just feels really fatigued after. She woke up twice and her whole body was soaked. She states that is all gone now. She has had no fever. She had a very good night last night. She stated her aches and pains were at a minimal. She stated she is 73 years old, so she is going to have aches and pains as it is. At the time of the report, all she has is fatigue. She added that the fatigue isn't coming from her, it's from the vaccine. She was very active usually. But at the time of the call, she would get up to do a little and then she would have to sit back down. She was very tired. She was feeling weak and out of pocket. She was so tired. She didn't want to do anything. She stated she must find someone who can print her new paperwork. She plans to call her doctor and see what he thinks about her receiving the second shot. She feels she really needs to get the second shot. During the report, she made the comment ""I'm sorry, I'm choking on my cough"". The patient underwent COVID-19 test on 14Jan2021 with result of negative. She also underwent blood test on an unspecified date with unknown results. The reported adverse events did not require a visit to the physician office or emergency room. Outcome of the event fatigue was not recovered, while outcome of the other events was recovered on an unspecified date in Jan2021. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/01/2021,,PUB,,Lupus-like syndrome,,,,"['Arthralgia', 'Asthenia', 'Back pain', 'Blood test', 'Body temperature', 'Chills', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Hyperhidrosis', 'Loss of personal independence in daily activities', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1056602,FL,73.0,M,"Urinary tract infection; when the doctor pushed on his bladder it hurt; tightness in his head; cold sweats; fever/went up to 101, 101.8, 101.9/temperature would go up to 100 or 101; Headache; Flu-like symptoms; stiffness of his body; dizziness/woozy; dizziness occurred when he stood up to leave/had dizziness and it went away and possibly occurred because he got up too quick; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscularly on the left arm, on 12Jan2021 14:00, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient and his wife went to the local senior citizen center on 12Jan2021 to get the vaccine. After which the patient noticed a slight dizziness on 12Jan2021 which was minimal, and the dizziness was something that was normal for him. The dizziness started within 15 minutes time frame after receiving the vaccine. The dizziness occurred when he stood up to leave on 12Jan2021; now the dizziness has recovered. He stated he had dizziness and it went away and possibly occurred because he got up too quick. He also felt a little woozy on 12Jan2021 and it was under control. The next day, on 13Jan2021, after receiving the vaccine he experienced fever, headache, almost flu-like symptoms, and stiffness of his body. His fever went up to 101, 101.8, 101.9 that night of 13Jan2021; earlier in the afternoon of 13Jan2021 around 15:00, he noticed a weirdness as he had a tightness in his head and then discovered he had a fever. He also had cold sweats, on the night of 13Jan2021, and his clothing was soaked - this occurred on a couple of evenings since then. Furthermore, he noticed in Jan2021 there was a cycle that continued where he did not have high temperature in the morning, his temperature was around 99 after breakfast and then his temperature would go up to 100 or 101 towards the evening. The fever lasted quite a while until 21Jan2021, about 8 days. He had a virtual visit on 21Jan2021 with his primary care provider since he had a fever. He also had a covid test that was negative on 21Jan2021. He then added that he also had a negative covid test on 18Jan2021; it was not the rapid test but a test that started with a ""p"". With these, his primary care provider was very much concerned, and he had a battery of tests done then he was discovered to have a urinary tract infection (UTI) on 22Jan2021. He informed that his primary care provider asked him to go into the office since the primary care provider was convinced that it was something more than just a reaction to the Pfizer covid vaccine. He had more tests on 22Jan2021 and that was when he was diagnosed with a UTI. It was a minimal UTI, not of any consequence, that when the doctor pushed on his bladder it hurt on 22Jan2021. He then received an intravenous antibiotic in the emergency room for the UTI but confirmed that he was not admitted. He stated that he has never had a reaction to any medication he has taken before. He then asked if he should get the second dose, the ""booster"" of the covid vaccine. He admitted he was quite reluctant to get the second dose that was scheduled for 02Feb2021 and his primary care provider advised against getting the second dose. The outcome of the event dizziness/woozy and dizziness occurred when he stood up to leave/had dizziness and it went away and possibly occurred because he got up too quick was recovered on 12Jan2021. The outcome of the event fever was recovered on 21Jan2021. The patient was recovering from UTI. The outcome of the events tightness in his head and when the doctor pushed on his bladder it hurt was unknown. The outcome of the events headache, flu-like symptoms, stiffness of his body and, cold sweats was recovered on Jan2021 (duration reported as ""-12 day""). All adverse events resulted in an emergency room visit and a physician office visit.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,UNK,,,,,,"['Bladder pain', 'Body temperature', 'Cold sweat', 'Dizziness', 'Dizziness postural', 'Headache', 'Influenza like illness', 'Investigation', 'Musculoskeletal stiffness', 'Pyrexia', 'SARS-CoV-2 test', 'Tension headache', 'Urinary tract infection']",1,PFIZER\BIONTECH,OT 1056603,,,U,IgG test that was zero; This is a spontaneous report from a non-contactable physician via a Pfizer-sponsored program. A patient of unspecified age and gender received the second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; unknown lot number and expiration date) with unknown age of vaccination via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; unknown lot number and expiration date) with unknown age of vaccination via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The reporter mentioned that one of the doctors that she knows had an IgG test that was zero on an unspecified date after getting the second dose of the covid vaccine. The physician was asking how does that doctor that had the IgG test of zero know they are protected. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Blood immunoglobulin G', 'Blood immunoglobulin G decreased']",2,PFIZER\BIONTECH, 1056604,CT,52.0,F,"both eyes swollen/ one eye was swollen shut; both eyes watery; Vision is blurry; Eyes were itchy and painful; Eyes got very puffy; Minimal discharge; both eyes itching/Eyes were itchy and painful; both eyes red/Eyes got very puffy and very red; This is a spontaneous report from a contactable consumer. This consumer reported for 2 patients. This is the first of 2 reports. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm at the age of 52 years, on 07Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included ongoing breast cancer stage ii , mastectomy from Jun2018 to an unknown date. Concomitant medication included anastrozole (ANASTROZOLE), escitalopram oxalate (LEXAPRO) and atenolol (ATENOLOL). The patient previously took taxol and experienced drug hypersensitivity. The patient stated that this past Sunday (24Jan2021) that her daughter woke up with both eyes swollen, red, watery and itching. It was stated that they took her to the clinic and was told that this was the second one that they had seen like this. It was also stated that they gave her a prescription for eye drops. It was stated that she woke up this morning and one eye was swollen shut and wanted to know what to do or the course of action. It was stated that she was supposed to get her second shot Thursday and wanted to know if she should get her second dose or not. It was also stated that her eyes were swollen and red which were better yesterday and today are worst than they have ever been. It was stated that the left eye is more swollen than the right. It was also stated that she soaked tea bags and put them on her eyes Sunday and stated that she does not know the name of the prescription eye drops. On 17Jan2021, it was reported that the patient's eyes got very puffy and very red. Her eyes were itchy and painful with minimal discharge. Her vision was also blurry. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 12Jan2021, sars-cov-2 test: negative on 19Jan2021 and sars-cov-2 test: negative on 25Jan2021. Therapeutic measures (Eye drops; Prednisone; Polymixin) were taken as a result of both eyes swollen/ one eye was swollen shut (eye swelling), both eyes red/eyes got very puffy and very red (ocular hyperaemia), both eyes watery (lacrimation increased), both eyes itching/eyes were itchy and painful (eye pruritus), vision is blurry (vision blurred) , eyes were itchy and painful (eye pain), eyes got very puffy (periorbital swelling) and minimal discharge (eye discharge). The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106157 similar report from same reporter",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/17/2021,10.0,SEN,ANASTROZOLE; LEXAPRO; ATENOLOL,Breast cancer stage II,Medical History/Concurrent Conditions: Mastectomy,,,"['Eye discharge', 'Eye pain', 'Eye pruritus', 'Eye swelling', 'Lacrimation increased', 'Ocular hyperaemia', 'Periorbital swelling', 'SARS-CoV-2 test', 'Vision blurred']",1,PFIZER\BIONTECH, 1056605,CT,,F,"both eyes swollen; both eyes red; both eyes watery; both eyes itching; This is a spontaneous report from a contactable consumer. This consumer reported for 2 patients. This is the 2nd of 2 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 07Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient woke up with both eyes swollen, red, watery and itching on 24Jan2021. The outcome of the events were not recovered. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021105990 similar report from same reporter",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/24/2021,17.0,UNK,,,,,,"['Eye pruritus', 'Eye swelling', 'Lacrimation increased', 'Ocular hyperaemia']",UNK,PFIZER\BIONTECH, 1056606,NC,78.0,F,"sore arm; This is a spontaneous report from a contactable consumer. This consumer reported same event for different patients. This is the second of two reports. A 78-year-old female patient received COVID vaccine (trade name unspecified), via an unspecified route of administration at left arm on 19Jan2021 17:45 at single dose for COVID-19 immunization. The patient medical history was no, no other products, no investigation assessment. Family medical history relevant to event was none. No prior vaccinations within 4 weeks. Vaccination facility type was clinic. Vaccine was not administered at military facility. The patient's concomitant medications were none. The patient experienced sore arm after getting the shot on 19Jan2021. No visit to emergency room or physician office. Her husband asked about this being related to the change of life but she didn't think so. The outcome of the event was recovered on Jan2021 (Duration of reaction was also reported as -18 days). Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021102026 same drug, same event and different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['Pain in extremity'],UNK,PFIZER\BIONTECH, 1056607,CA,,F,"Headache; Chills; Body pain; Nausea; This is a spontaneous report from a non-contactable other-hcp (patient). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3248) in left arm intramuscularly on an unspecified date at single dose for COVID-19 immunization. Medical history included covid (if Covid prior vaccination: Yes). No known allergies. The patient's concomitant medications were not reported. The patient experienced headache, chills, body pain, nausea, all on 25Jan2021. No treatment received. Patient was not pregnant. Unknown if Covid tested post vaccination. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/25/2021,,PVT,,,Medical History/Concurrent Conditions: COVID-19 (if Covid prior vaccination: Yes),,,"['Chills', 'Headache', 'Nausea', 'Pain']",1,PFIZER\BIONTECH,OT 1056608,FL,92.0,F,"Swelling on left side of face; This is a spontaneous report from a contactable consumer reporting for self. A 92-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in left upper arm on 23Jan2021 at single dose for covid-19 immunisation. Medical history included osteoporosis and Kidney disease. There were no concomitant medications. The patient experienced swelling on left side of face on 23Jan2021 occurred shortly after the shot, it is going down, she was taking antihistamines. Outcome of event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/23/2021,0.0,UNK,,,"Medical History/Concurrent Conditions: Kidney disorder (Verbatim: kidney disease At least 10-15 years ago); Osteoporosis (Verbatim: Osteoporosis Diagnosed quite a few years ago, it has been a while)",,,['Swelling face'],1,PFIZER\BIONTECH, 1056609,AR,,F,"fever/her mother is running a fever of 101; tiredness; cough; headache; muscle pain; chills; joint pain; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. This consumer reported similar events for different patients. This is the second of two reports. A female patient of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the consumer that both her parents got the first dose of the covid 19 vaccine and afterwards they got fever (mother has a running fever of 101), tiredness, cough, headache, muscle pain, chills and joint pain. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021080983 same drug, similar events, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/01/2021,,UNK,,,,,,"['Arthralgia', 'Body temperature', 'Chills', 'Cough', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1056610,LA,71.0,F,"Nauseated; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 20Jan2021 01:30 at single dose for covid-19 immunization. Medical history included heart problem, she is a pump diabetic user/diabetes, mini stroke, Heart attack. The Family Medical History included heart problems and diabetes. There were no concomitant medications. Patient took the Pfizer COVID vaccine. She was reading the side effects and was wondering if she would have side effects this long after having the shot. She woke up today (26Jan2021) feeling nauseated and started diarrhea this morning. This is day 6 after the shot. No treatment. The outcome of the events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/26/2021,6.0,UNK,,,Medical History/Concurrent Conditions: Diabetes; Heart attack; Heart disorder; Stroke,,,"['Diarrhoea', 'Nausea']",UNK,PFIZER\BIONTECH, 1056611,TN,78.0,F,"Swelling, which is hard like an egg, at the injection site; Redness at the injection site; Very lethargic; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry date unknown), via an unspecified route of administration at the age of 78 years, on 22Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus, ongoing urinary tract infection, hyperparathyroidism from 21Jan2021 and ongoing, ongoing osteopenia, ongoing meningioma, seizure from an unknown date and unknown if ongoing. The patient received the first dose on 02Jan2021. On 23Jan2021, the patient experienced swelling, which was hard like an egg, at the injection site and redness at the injection site. The patient was also very lethargic on an unspecified date. No treatment was received for the events. The outcome of the event lethargic was unknown while other events were not recovered. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/01/2021,,UNK,,Hyperparathyroidism (Verbatim: Hyperparathyroidism); Meningioma (Verbatim: Meningiomas/ Diagnosed about a year and half ago and had brain surgery for this.); Osteopenia (Verbatim: Osteopenia/ Coming from the thyroid. Diagnosed about 6 weeks ago.); Type II diabetes mellitus (Verbatim: Type II diabetes mellitus/ Diagnosed about 10 years ago); UTI (Verbatim: UTI/Has had off and on for two years. Takes medication for this.),Medical History/Concurrent Conditions: Seizure (Anti-seizure medication),,,"['Lethargy', 'Vaccination site erythema', 'Vaccination site swelling']",2,PFIZER\BIONTECH, 1056612,OH,67.0,M,"Shingles; This is a spontaneous report from a contactable physician. A 67-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in his left arm, via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the COVID Vaccine about 10-12 days ago. He got facial shingles about 10 days after getting the vaccine. He has never had shingles before. This was his first dose. He clarifies that he in fact got shingles 5 days after getting the vaccine on 21Jan2021, instead of 10 days after getting the vaccine. He was not going to get treatment but then it got worse. He is on Valtrex 1 Gram three times a day and Mupirocin topical ointment. The outcome of the event was recovering. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/21/2021,5.0,UNK,,,,,,['Herpes zoster'],1,PFIZER\BIONTECH, 1056613,MI,73.0,M,"whole back and side of his right leg was covered with very large, itchy welts from his right buttocks down to his right ankle; small itchy areas on the front of his right leg; This is a spontaneous report from a contactable consumer (patient's wife). A 73-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3249, expiry date unknown), via an unspecified route of administration on 20Jan2021 at 16:30 at a single dose on the left deltoid (reported as 'left shoulder') for COVID-19 immunization. The patient had no medical history and there were no concomitant medications. The patient had no prior vaccinations within 4 weeks before the COVID-19 vaccine. It was reported that the patient initially had no problem after receiving his first dose of the COVID-19 Vaccine, but on 23Jan2021 (also reported as 2-1/2 days later), he woke up in the middle of the night, at approximately 3:00am, and the whole back and side of his right leg was covered with very large, itchy welts from his right buttocks down to his right ankle. The patient also had some small itchy areas on the front of his right leg, but no other parts of his body. She said she gave her husband Benadryl 50mg, and put some hydrocortisone cream on his welts, and that seemed to take care of the welts. The reporter told her brother about the welts her husband (patient) developed after receiving his first COVID-19 Vaccine dose. She said her brother was questioning if maybe her husband had a delayed reaction to the COVID-19 Vaccine. She said her brother said her husband's welts may have been caused by spiked proteins developing from the COVID-19 Vaccine administration. The reporter asked if it is safe for the patient to get the second COVID-19 Vaccine dose, which he is scheduled to receive on 10Feb2021. The patient took 2 Welby generic Benadryl 25mg capsules (lot number: 9DR0738, expiry date: Dec2020) when he first discovered the large, itchy welts on the back and side of his right leg. Then the patient took another 2 Welby generic Benadryl 25mg capsules before he went to bed later that day. The reporter topically applied the product ""After Bite"" to the patient's itchy welts. The reporter clarified that After Bite (lot number: 32812) is not hydrocortisone cream, like she thought, but a Sodium Bicarbonate and Aloe Vera product. The reporter added that the patient's very large, itchy welts are very faded on the back and side of his right leg, but there remains a couple small spots. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/23/2021,3.0,PUB,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH, 1056614,MI,68.0,F,"lumps in back of neck, they hurt; lumps in back of neck, they hurt; pain goes around into jaw, up into the face; pain goes around into jaw, up into the face; ear hurts; felt dizzy; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 23Jan2021 at a single dose for covid-19 immunization. Medical history included high blood pressure (Diagnosed 3 to 4 years ago) and thyroid disorder. There were no concomitant medications. It was reported that the patient got the vaccine on Saturday and went home and fell asleep, woke up and had lumps in back of neck, they hurt, pain goes around into jaw, up into the face and ear hurts. The patient just tried a hot compress, a hot cloth on there, it seemed to help a little bit for a while. Took some Advil and that helped a little bit, but when it wears off it comes back. Adds she felt dizzy too, and still felt like that too, it started right after she got it, and it comes and goes. The outcome of the event dizzy was unknown while not recovered for the remaining events. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/23/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure high (Diagnosed 3 to 4 years ago); Thyroid disorder,,,"['Dizziness', 'Ear pain', 'Facial pain', 'Neck mass', 'Neck pain', 'Pain in jaw']",1,PFIZER\BIONTECH, 1056615,TX,91.0,F,"Nausea; Diarrhea; Kind of not feeling good; Throwing up; This is a spontaneous report received from a contactable consumer (patient's daughter). A 91-year-old (also reported as 92-year-old) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date unknown), intramuscular on the right arm, on 25Jan2021 19:00, at single dose, to prevent covid/COVID-19 immunization. There were no medical history and concomitant medications. It was reported that the patient had the first shot of the vaccine on 25Jan2021 at 19:00 (yesterday). The patient was surprised that the shot did not hurt going in and she was not having any pain in the arm. On 26Jan2021 (this morning), the patient was experiencing nausea, diarrhea, was throwing up and was feeling kind of not good. The patient stated that the side effects were ongoing. No treatment was given for the events. The outcome of the events was not resolved. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Diarrhoea', 'Malaise', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,OT 1056616,NY,50.0,M,"Little back problems, lower back; hurts(Back); My arm is hurting; my arm was killing me; my arm hurts; I throw up twice yesterday; I got a little sick; I just got a little chill; I got chills on the lower part of my back; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3247), via an unspecified route of administration at the age of 50 years, on 25Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient stated, ""Yesterday I took my second vaccine shot and my side effects this morning was a little back problems, lower back, my arm is hurting, and I throw up twice yesterday, I got a little sick. So, I just wanted to call and let somebody know."" It was also stated, ""Yesterday when I got home after the shot, I just got a little chill and then I laid down, I throw up twice and I just laid down and laid down. And when I woke up I was calling you all since 1 in the morning because my arm was killing me."" It was stated, ""Yes, my arm hurts and my back, I am in my house and I got the back thing on for, the heating pad (treatment), just for my back."" The consumer stated, ""I took aspirin because I throw up twice yesterday so I just took aspirin. And then I was laid down and I woke up this morning and I took one in the morning. I have been trying to call you all morning, all morning I just got, just to let you know that my arm is hurting and I got a chills on the lower part of my back."" Therapeutic measures were taken as a result of little back problems, lower back; hurts(back) (back pain), i throw up twice yesterday (vomiting). The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Back pain', 'Chills', 'Illness', 'Pain in extremity', 'Vomiting']",2,PFIZER\BIONTECH, 1056617,SC,47.0,F,"sweating; nauseated; really bad migraine migraine/always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was worst and more diarrhea; really bad migraine migraine/always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was more diarrhea; This is a spontaneous report from a contactable consumer (patient's husband). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261 and expiry date: May2021), via intramuscular route of administration on 26Jan2021 at 11:30 at 0.3 mL, single on the left arm for COVID-19 immunization. Medical history included ongoing migraine and vomiting. Concomitant medications included ongoing sumatriptan succinate (IMITREX) for migraine, ongoing nadolol for migraine, ongoing sertraline for migraine, and ongoing ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50). On 26Jan2021 at 13:00, the patient experienced really bad migraine. The patient always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was worst and more diarrhea. The husband does not know if it was because of the shot or if it was because of the warm front that they are receiving because sometimes that can trigger her migraines. The husband reported that it was pretty typical for her and she will sleep with a fan on, but today she is actually covered up (for clarification) and does not want the fan on. Patient also started sweating and got nauseated on an unspecified date. The husband wanted to know if he needs to take her to the doctor. The outcome of the events really bad migraine and diarrhea was not recovered while the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,UNK,IMITREX; NADOLOL; SERTRALINE; CENTRUM SILVER +50,Migraine,Medical History/Concurrent Conditions: Vomiting,,,"['Diarrhoea', 'Hyperhidrosis', 'Migraine', 'Nausea']",1,PFIZER\BIONTECH,OT 1056618,NJ,57.0,F,"bad pain in the arm; pain in the arm like can barely move it; little soreness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262 and expiry date: unknown), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included breast cancer. Concomitant medication included letrozole. Patient received the vaccine on Saturday and last night on 25Jan2021 and the morning of 26Jan2021, patient was having a very bad pain in the arm like can barely move it. She was fine until last night. She had a little soreness on Saturday (23Jan2021) and the night of 25Jan2021 and the morning of 26Jan2021, she can barely lift it. The pain was really a lot and patient did not know if this was normal. She knew that there was supposed to be some soreness right afterwards but this was like a day and a half later. Patient took TYLENOL as treatment for the events. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,01/23/2021,0.0,UNK,LETROZOLE,,Medical History/Concurrent Conditions: Breast cancer female,,,"['Movement disorder', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 1056619,TN,53.0,F,"suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); Headache; Chills; Nausea; swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1686), via an unspecified route of administration on the arm/deltoid, on 07Jan2021, at single dose, for covid-19 immunization. Medical history included suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP). The patient had questions about some side effects from the COVID vaccine. She stated she received the first dose on 07Jan2021. About a week after that or maybe 7 to 9 days after the first shot, she started having side effects and was given a handout of a different side effects and risk of the vaccine and; she had like 4 or 5 of the side effects on Jan2021 such as headache, chills, nausea and swollen lymph node. She started with the headache initially then the chills, and nausea, and then lymph node. Her lymph nodes were still swollen. She informed was due to get the ""booster"" vaccine this Thursday (28Jan2021) and she just wanted to call and see if she should still go and get the booster vaccine with the swollen lymph nodes. She added she did get a test for the COVID this past Thursday (21Jan2021), because of the symptoms, and it was negative. She had the test because she didn't know if it was the vaccine side effect because the side effect also fell in line with actual COVID symptoms. She wanted to make sure that she didn't have the virus. At the time of the report she had not recovered from the adverse events headache, chills, nausea and swollen lymph node and she did not receive any treatment for these. The outcome of the other remaining events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/01/2021,,OTH,,,Medical History/Concurrent Conditions: Idiopathic thrombocytopenic purpura (suffering from an auto immune disorder),,,"['Chills', 'Headache', 'Lymphadenopathy', 'Nausea', 'Off label use', 'Product use issue', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1056620,TN,36.0,F,"arm pain; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899 and expiry date: unknown), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first vaccine back and everything went great. She had that usual arm pain on Jan2021. There was no treatment for the event. Outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/04/2021,01/01/2021,,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1056621,,,F,"Her back went out; She can't stand, she can't walk because of that; Her back went out; She can't stand, she can't walk because of that; Her back went out; She can't stand, she can't walk because of that; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 reported as COVID 19 VACCINE; lot number: EL3249; expiration date: unknown) at unknown age of vaccination via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that got the first dose of the vaccine last Friday (22Jan2021) and last Saturday (23Jan2021) her back went out. She further reported that means she can't stand, she can't walk because of that. The patient inquired if she can take Prednisone and if she will take Prednisone, would that affect the efficacy of the vaccine. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/23/2021,1.0,UNK,,,,,,"['Back disorder', 'Dysstasia', 'Gait disturbance']",1,PFIZER\BIONTECH, 1056622,MA,51.0,M,"swollen lymph node under his left arm; I feel tingling in my arm; I turn my neck to the right side, I feel like little pain on the neck side; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231) via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included blood pressure (abnormal) and diabetes. Concomitant medication included lisinopril for blood pressure, amlodipine, atorvastatin and metformin for diabetes. The patient previously received first dose of BNT162B2 on 02Jan2021 for COVID-19 immunization. The patient had his second shot of his COVID 19 vaccine and then the first day was okay but the second day (24Jan2021) was, he had like swollen lymph node under his left arm. And also, he felt tingling in his arm. And when he turned his neck to the right side, he felt like little pain on the neck side. ""I don't know if this will go away or what. This is the third day I had the vaccine."" Consumer stated, ""I took Ibuprofen."" The patient underwent lab tests and procedures which included lab on an unspecified date with unknown results (the patient don't have it, his primary care have it). Outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/24/2021,1.0,UNK,LISINOPRIL; AMLODIPINE; ATORVASTATIN; METFORMIN,,Medical History/Concurrent Conditions: Blood pressure abnormal; Diabetes,,,"['Laboratory test', 'Lymphadenopathy', 'Neck pain', 'Paraesthesia']",2,PFIZER\BIONTECH, 1056623,FL,74.0,M,"Had stomach cramps for three hours. It was very painful, it felt like he had a knife sticking in him.; Severe headache; Flu symptoms; Congestion; This is a spontaneous report from a contactable consumer reporting for himself. A 74-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1686), intramuscular on left arm on 09Jan2021 12:45 at SINGLE DOSE for to prevent COVID-19 (covid-19 immunisation), at 74 years old. Medical history included ongoing severe COPD from 2014, and ongoing idiopathic pulmonary fibrosis from 2020. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EH9899) on 28Dec2020 (age at vaccination 74 years old) and experienced First Covid-19 Vaccine: flu-like symptoms, whole left arm muscle was sore, joint in his elbow was like somebody had a knife sticking in it. No other prior vaccinations within 4 weeks. The patient stated that the first day was okay. The patient experienced had stomach cramps for three hours. It was very painful, it felt like he had a knife sticking in him (Wednesday night), and severe headache on 20Jan2021 for 3 days (also reported as lasted Wednesday, Thursday, Friday and half a day Saturday/3.5 days), and flu symptoms and congestion on an unspecified date Jan2021. The patient thought he had food poisoning, but his wife ate the same food he did. Patient stated he didn't have food poisoning. He stated that after 3.5 hours of lying in bed and not being able to move, the cramping just went away, like someone flipping a light switch. His flu symptoms have gone away as of 26Jan2021. He stated that during reporting time, was the best he felt after the shot which was a week ago. He stated he was over the side effects as of reporting. The events did not require emergency room or physician office visit. No relevant lab tests. Patient mentioned he was getting a complete blood workup. Outcome of the event ""Had stomach cramps for three hours. It was very painful, it felt like he had a knife sticking in him"" was recovered on 20Jan2021, severe headache was recovered on 23Jan2021, Flu symptoms and Congestion were recovered on 26Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/01/2021,,UNK,,COPD (Verbatim: Severe COPD); Idiopathic pulmonary fibrosis (Verbatim: Idiopathic pulmonary fibrosis),,,,"['Abdominal pain upper', 'Headache', 'Influenza', 'Nasal congestion']",2,PFIZER\BIONTECH,OT 1056624,MI,69.0,F,"The pressure across my chest and like under my ribs about 6 inch hold away across; I did feel like vomiting; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), Batch/lot number: EL9261, via an unspecified route of administration on 22Jan2021 at single dose in left arm for COVID-19 immunisation. Medical history included bypass surgery in Mar, diabetic and seizures from an unknown date and unknown if ongoing. The patient was taking several medications. Patient stated she had the first vaccine (Covid-19 Vaccine by Pfizer) on last Friday and done okay but then she had 10 O'clock in the morning and about 1 O'clock in the morning she woke up with all the pressure across her chest and like under her ribs about 6 inch hold away across and she did feel like vomiting and she was wondering if that was a reaction to that shot and if she should get the second one, she was just kind of concern what she should do it. No treatment was received for the events. The events didn't require Physician Office/ Emergency Room visit. The patient didn't perform any test. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,,,UNK,,,Medical History/Concurrent Conditions: Bypass surgery (I had Bypass surgery in Mar); Diabetic; Seizures,,,"['Chest discomfort', 'Nausea']",1,PFIZER\BIONTECH, 1056625,WI,67.0,F,"I really hurt so bad all over; I hurt all over like right leg, left leg, upper body; Headache; My arm was just little uncomfortable; patient with fibromyalgia was given Pfizer Covid-19 Vaccine; patient with fibromyalgia was given Pfizer Covid-19 Vaccine; I am getting nightmares, it's like I am struggling; Fibromyalgia/never have 'flare-up' this bad; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL1283; expiration date: unknown) at 67-year-old age of vaccination via an unspecified route of administration in the left arm on 21Jan2021 at a single dose for covid-19 immunization. Medical history included fibromyalgia. The patient's concomitant medications were not reported. The patient reported that she got her vaccine on a 21Jan2021 (Thursday) and on Friday (22Jan2021), her arm was just little uncomfortable but its fine. On Saturday by 4 o' clock (23Jan2021), she really hurt so bad all over and with headaches. By Sunday (24Jan2021), it went down a little bit and it was going away but last night (unspecified date in 2021), it hit again it just waking her up and she was getting nightmares, it's like she was struggling. She mentioned that she has a history of Fibromyalgia, but she never has 'flare-up' this bad on unspecified date in 2021. It was reported that the patient with fibromyalgia was given Pfizer Covid-19 Vaccine. She further stated that she hurt all over like right leg, left leg, upper body. The patient received treatment of acetaminophen (TYLENOL). The adverse events did not require an emergency room/ physician office. She mentioned that she has read all literature, it says you can get side effects, but this isn't normal. The outcome of the events limb discomfort, pain and headache were recovering while the outcome of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Fibromyalgia,,,"['Fibromyalgia', 'Headache', 'Limb discomfort', 'Nightmare', 'Off label use', 'Pain', 'Product use issue']",UNK,PFIZER\BIONTECH, 1056626,NC,94.0,F,"Vertigo last week that stayed for five days; pain at the injection site; 2 stroke like symptoms/ like she was having a TIA (Reporter confirmed TIA as Transient ischemic attack); Blood Pressure 170/130; Fatigue; Joint ache; Nausea; Vomiting; Fever 100.1; Stress; 2 stroke like symptoms/numbness in her lip; Pervasive aching; Momentary confusion; , like she was having a TIA; Not able to answer questions; she still has not recovered her strength; This is a spontaneous report from a contactable consumer (patient's daughter). A 94-year-old female patient (mother) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL1283), via an unspecified route of administration on 23Jan2021 13:00 at a single dose for COVID-19 immunisation. The patient's medical history included ischaemic stroke, haemorrhagic stroke in Aug2019, pulmonary embolism, deep vein thrombosis (DVT), cholesterol, myalgia condition, blood pressure, thyroid, sleep and vertigo. The patient concomitant medications included amlodipine for blood pressure, calcium carbonate/colecalciferol (CALCIUM + VITAMIN D), rosuvastatin calcium (CRESTOR) for cholesterol, levothyroxine for thyroid, eszopiclone (LUNESTA) for sleep medication, ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2), prednisone for myalgia condition, and escitalopram. The patient experienced fatigue, joint ache, nausea, vomiting, blood pressure 170/130, fever 100.1, stress, stroke like symptoms, numbness in her lip, momentary confusion; like she was having a TIA; not able to answer questions, tired, pervasive aching, all on 23Jan2021 19:00. Events reported as follow: patient had the Pfizer vaccine on Saturday around 1 pm and Saturday (Clarified 23Jan2021) night she had severe side effects for about 4 hours. When probed for side effects, the reporter stated it increased gradually over time. So, first patient had joint achiness and then she experienced nausea and vomiting. The reporter took her blood pressure. It was 170/130 and so reporter called EMS and they came up and her blood pressure had gone back down to normal and they recorded she had a fever of 100.1. EMS believed that the combination of the 'violence' of the onset and the fever caused her blood pressure to spike but she had a history of ischemic and hemorrhagic stroke. So, the reporter was concerned that the stress and whatever that was going on the reaction, the reporter was concerned that it was going to cause her a stroke. Patient had 2 stroke like symptoms, one was that she had numbness in her lip and the second was that she had momentary confusion, like she was having a TIA (reporter confirmed TIA as Transient ischemic attack). The only symptom of that was when the reporter asked her the name of her children she gave the names of her grandchildren but that confusion cleared up quickly and she was fine for a while but not able to answer questions, sharply. By the time that EMS got there patient was sharp again, no problem. For treatment, the reporter gave patient aspirin. The reporter put some Salonpas patches on her joints. It was like the analgesic patch. It was an external patch that patient put on. Patient usually does not need them that was why she was taking the prednisone to treat that kind of pervasive aching. The reporter also gave her the fluids, Gatorade kind of stuff to replace her fluids from throwing up and that kind of stuff. One more thing, it all started with an extreme fatigue but that seem normal but it seemed to lead into the other symptoms. Like it was a big day to go out and get the vaccine. So, she was a little bit tired. This was a very deep fatigue that was part of it too. Reporter stated only 81 aspirin (later clarified as treatment) as she could not go back on blood thinners because she had the hemorrhagic stroke. As of 11Feb2021, it was reported that patient still has not recovered her strength since 23Jan2021 19:00 and was reported as ongoing but improved. On 03Feb2021, the patient had vertigo that stayed for five days and was now improved. The patient was scheduled for the second dose on 13Feb2021. The immediate effects her mother had after the first dose of the vaccine were pain at the injection site; fatigue; fever; nausea. Mentions she also had some confusion and they were worried that the patient might be having another stroke. But all of this cleared up; all of this in a violent episode that lasted about four hours. Today she wants to report that her it took her a week for her mother to recover. Adds her mother could walk for half an hour before the vaccine but since the vaccine she still has not recovered her strength. Adds her mother has only been able to walk about 15 minutes with a walker and resting a lot, for a couple time in three weeks and this was their main way of maintaining her health. Adds her mother also had some vertigo last week that stayed for five days but she has had that in the past. Adds actually she still has the vertigo a little and she can tell when her mother bends her head. Outcome of blood pressure 170/130, she still has not recovered her strength and vertigo was recovering, outcome of events pain at the injection site, fatigue, fever, nausea and confusion was recovered on 23Jan2021 23:00; other events was unknown. No investigation assessment. Follow-up (11Feb2021): New information received from the same contactable consumer (patient's daughter) includes: reporter details, medical history, reaction data and course of events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/23/2021,0.0,UNK,AMLODIPINE; CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]; CRESTOR; LEVOTHYROXINE; LUNESTA; PRESERVISION AREDS 2; PREDNISONE; ESCITALOPRAM,,Medical History/Concurrent Conditions: Blood pressure abnormal; Cholesterol; DVT; Hemorrhagic stroke; Ischemic stroke; Myalgia; Pulmonary embolism; Sleep disorder (Sleep medication); Thyroid disorder; Vertigo,,,"['Arthralgia', 'Asthenia', 'Blood pressure measurement', 'Body temperature', 'Confusional state', 'Fatigue', 'Hypertension', 'Hypoaesthesia oral', 'Nausea', 'Pain', 'Pyrexia', 'Stress', 'Transient ischaemic attack', 'Vaccination site pain', 'Vertigo', 'Vomiting']",1,PFIZER\BIONTECH, 1056627,,81.0,F,"woke up in the middle of the night sweating; whole left shoulder, arm and hand was very sore and achy; whole left shoulder, arm and hand was very sore and achy; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 21Jan2021 at a single dose on the right arm to be inoculated against the virus. The patient has no medical history and there were no concomitant medications. The patient reported that she got the Pfizer vaccine shot last Thursday, 22Jan2021 and while she was there she didn't have any reaction. She had the vaccine in her right arm because she was left handed and by the time she got home, her whole left shoulder, arm and hand was very sore and achy. She had trouble with her left shoulder, she didn't know if it was the co-incident (as reported) or not and then it kind of then the patient took some Tylenol and it kind of eased up. The patient then reported that on 22Jan2021, Friday night, she woke up in the middle of the night sweating and that happened during the night and in the morning it went, but it is still there but she still has soreness in her left shoulder, arm and hand and it kept her up last night. She didn't know if this was going to be a symptom of the vaccine. She wanted to know that when she will get the second one, is it going to be worst and what she was supposed to do. The patient was scheduled to get the second dose on 11Feb2021. The patient reported unspecified labs with unknown results. The outcome of the events whole left shoulder, arm and hand was very sore and achy was not recovered while the outcome of woke up in the middle of the night sweating was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Investigation', 'Night sweats', 'Pain in extremity']",1,PFIZER\BIONTECH, 1056628,,,F,"cheeks started to get kind of red and burning; cheeks started to get kind of red and burning; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration, on 25Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer Covid19 shot yesterday on 25Jan2021 and as soon as she got home her cheeks started to get kind of red and burning and it subsequently did it through the night. This morning it seemed better. However, this afternoon it started again. She wanted to know what that was about and stated that it has to be a side effect. She asked if there was anyone reporting this. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/25/2021,0.0,UNK,,,,,,"['Erythema', 'Skin burning sensation']",1,PFIZER\BIONTECH, 1056629,CA,,M,"Very lethargic; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar event for two patients. This is the second of the two reports (husband). A male patient (Age: 71; unit was not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported) on 18Jan2021 at a single dose for COVID-19 immunization at the clinic. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient was very lethargic. The patient had COVID test in Jan2021 (results were not provided). The patient had no symptoms. The outcome of the event, 'very lethargic', was unknown. The patient was due to get the second dose of vaccination on ""the 8th"", but the schedule has not been filled up yet.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021115530 same reporter/product/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,01/01/2021,,OTH,,,,,,"['Lethargy', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1056630,CA,80.0,F,"Lightheaded; Weakness; Nauseated; Vomiting; did not have an appetite; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. Medical history included stroke 14 years ago. Concomitant medication included warfarin. The patient was lightheaded, did not have an appetite and experienced weakness on Jan2021. She was even nauseated and threw up earlier on Jan2021. She wanted to know what can she do. She had nauseousness and vomiting. She vomited one time but she was not currently vomiting and just took some Ginger ale to settle her stomach. Patient was asking what to drink or does she take any Tylenol or let it. Outcome of the events was unknown. The date of second dose was 16Feb2021 Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/01/2021,,UNK,WARFARIN,,Medical History/Concurrent Conditions: Stroke (14 years ago),,,"['Asthenia', 'Decreased appetite', 'Dizziness', 'Nausea', 'Vomiting', 'Weight']",1,PFIZER\BIONTECH, 1056631,NY,,F,"Wife have had a reaction, the rash; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. It was stated, ""I have a married couple on the other line. He took the Covid-19 vaccine, the wife have had a reaction, the rash, but the husband had no reaction."" The reporter stated, ""Correct, she had a rash 4 days after (Jan2021). We had the vaccine on Wednesday and the rash appeared on Sunday."" Therapeutic measures (Prednisone) were taken as a result of wife have had a reaction, the rash (rash). The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Rash'],UNK,PFIZER\BIONTECH, 1056632,,,M,"Chills; trying that he won't throw up; This is a spontaneous report from a contactable consumer. A male patient (reporter's Dad) of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: Unknown) on 25Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient experienced chills and he is trying that he won't throw up in Jan2021. Patient got the first COVID shot yesterday (Clarified as 25Jan2021) about 2:30 and about 26 hours later, he has no symptoms or nothing and just an hour ago it's been about 26 hours he has chills. Reporter asked if that is common. Reporter think he is trying that he won't throw up. Reporter have been thinking if he had the chills just a few hours after he got the shot. It's been about 26 hours. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/01/2021,,UNK,,,,,,"['Chills', 'Nausea']",1,PFIZER\BIONTECH, 1056633,SC,,F,"nausea; vomiting; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included patient took allergy medications before the 1st dose. The patient's concomitant medications were not reported. The patient experienced nausea and vomiting hours after 1st dose, and hesitant to take the 2nd shot. The outcome of events was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Allergy (taking allergy medications before the 1st dose),,,"['Nausea', 'Vomiting']",1,PFIZER\BIONTECH, 1056634,FL,,M,Said arm has been sore; This is a spontaneous report from a Pfizer-Sponsored Program Pfizer. A non-contactable consumer reported for a male patient with unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported arm had been sore for couple days after 1st dose. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1056635,GA,,F,"nausea is not huge; soreness is not huge; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reported for herself. A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness was not huge and nausea was not huge in Feb2021, she just wanted to know if she can take pain relievers. The outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/01/2021,,UNK,,,,,,"['Nausea', 'Pain']",1,PFIZER\BIONTECH, 1056636,CT,67.0,F,"itching on the skin of the back; Headache; malaise; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 04Feb2021 at 09:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unspecified date in Jan2021 (age at vaccination: 67 years) at 09:00 on the left arm for COVID-19 immunization. Prior to vaccination, was the patient has not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced itching on the skin of the back, headache and malaise on 05Feb2021 at 07:00. It was unknown if the patient received treatment for the events. The outcome of the events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,UNK,,,,,,"['Headache', 'Malaise', 'Pruritus']",2,PFIZER\BIONTECH, 1056637,MA,32.0,F,"Gave her an entire vial instead of one dose; Giant red circle/rash; Really swollen; Inflamed; Painful; This is a spontaneous report from a Pfizer-sponsored program, PFIZER FIRST CONNECT. A contactable consumer (patient) reported that a 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 04Feb2021 (10:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store (not a military facility). The patient did not have relevant medical history. Concomitant medication included ongoing amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient previously took a flu shot a couple of months ago, and had no reaction. On 04Feb2021 (10:00), the pharmacy reportedly screwed up, and gave the patient an entire vial of BNT162B2 instead of one dose. The patient was not feeling any side effects then. In Feb2021, the patient had a giant red circle/rash; and she was really swollen, inflamed and in pain (reported as ""painful""). The patient did not receive any treatment for the giant red circle/rash and pain. The outcome of the events was recovering for 'giant red circle/rash', 'really swollen', 'inflamed' and 'pain'; and was unknown for 'gave the patient an entire vial of BNT162B2 instead of one dose'. The reporter had asked about whether she should receive the second dose. Follow-up (08Feb2021): New information received from a contactable consumer (patient) included: reporter information, suspect vaccine details and new events ('giant red circle/rash', 'really swollen', 'inflamed' and 'pain').",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/01/2021,,PHM,ADDERALL,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Inflammation', 'Overdose', 'Pain', 'Rash erythematous', 'Swelling']",1,PFIZER\BIONTECH, 1056638,IL,47.0,F,"Rigors and severe back pain; Rigors and severe back pain; syncope; prolonged PT; Loss of work as a physician for 2.5 weeks; This is a spontaneous report from a contactable physician (patient) A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 11Jan2021 12:30 at single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease and allergies. The patient was not pregnant. Concomitant medication included lansoprazole (PREVACID). The patient experienced rigors and severe back pain, syncope, prolonged pt and loss of work as a physician for 2.5 weeks on 12Jan2021 with outcome of recovered with sequelae in Feb2021. The events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient was hospitalized due to the events for 2 days. The patient received steroids, pain meds, muscle relaxers as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship and known product safety profile causality between event chills and syncope and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be excluded. The events prolonged PT and loss of work as a physician for 2.5 weeks are attributed to intercurrent conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,2.0,Yes,N,01/11/2021,01/12/2021,1.0,PVT,PREVACID,,Medical History/Concurrent Conditions: Hypersensitivity; Reflux esophagitis,,,"['Back pain', 'Chills', 'Loss of personal independence in daily activities', 'Prothrombin time prolonged', 'Syncope']",UNK,PFIZER\BIONTECH, 1056639,MA,,M,"Left eye 6 nerve palsy and could not move my eye laterally; This is a spontaneous report from a contactable physician (patient) A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 27Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 01Feb2021, patient started to notice, left eye 6 oculomotor nerve (""abduscens"") palsy and could not move his eye laterally. Patient also asked information about 6 oculomotor nerve and possible interaction with vaccine. At the time of the reporting event outcome was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported event cannot be excluded, due to a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,02/01/2021,5.0,UNK,,,,,,['Paralysis'],1,PFIZER\BIONTECH, 1056640,FL,71.0,M,"Lt parietal occlusion; DVT; Right paralysis; This is a spontaneous report from a contactable Nurse reporting for her husband. A 71-years-old male patient received the first dose of bnt162b2 (BNT162B2; Lot # EL 1284) vaccine , intramuscular in the left deltoid on 22Jan2021 17:00 at single dose for Covid-19 immunisation . The patient medical history was not reported. Concomitant medication included apixaban (APIXABAN), acetylsalicylic acid (ASPIRIN) atorvastatin (ATORVASTATIN), cyanocobalamin (CYANOCOBALAMIN), metoprolol tartrate (METOPROLOL TARTRATE) , pantoprazole (PANTOPRAZOLE), sumatriptan (IMITREX [SUMATRIPTAN]), triazolam (TRIAZOLAM). The patient experienced DVT (deep vein thrombosis) on 26Jan2021 with outcome of not recovered , left parietal occlusion (ischaemic stroke) on 26Jan2021 05:30 with outcome of unknown , right paralysis on an unspecified date with outcome of unknown. The patient was hospitalized for DVT (deep vein thrombosis) and stroke from 26Jan2021 to 30Jan2021. The patient underwent lab tests and procedures including blood pressure diastolic: 84 mmhg on 30Jan2021 , blood pressure systolic: 141 mmhg on 30Jan2021 , body mass index: 26.4684 kg/m2 on 26Jan2021 , body temperature: 98.2 �F on 30Jan2021, heart rate: 55 bpm on 30Jan2021 , magnetic resonance imaging: acute left parietal lacunar infarct, Lower extremity ultrasound: left popliteal vein DVT, oxygen saturation: 95 % on 30Jan2021 , respiratory rate: 18 br/min on 30Jan2021. The reporter considered the reported events to be possibly related to BNT162B2 vaccine. Follow up information has been requested.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/22/2021,01/26/2021,4.0,PHM,APIXABAN; ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; CYANOCOBALAMIN; METOPROLOL TARTRATE; PANTOPRAZOLE; IMITREX [SUMATRIPTAN]; TRIAZOLAM,,,,,"['Angiogram', 'Blood pressure diastolic', 'Blood pressure systolic', 'Body mass index', 'Body temperature', 'Cardiovascular examination', 'Computerised tomogram', 'Deep vein thrombosis', 'Echocardiogram', 'Gastrointestinal examination', 'Heart rate', 'Ischaemic stroke', 'Magnetic resonance imaging', 'Ophthalmological examination', 'Oxygen saturation', 'Paralysis', 'Respiratory rate', 'Skin test', 'Thermometry', 'Ultrasound joint']",1,PFIZER\BIONTECH,OT 1056641,OH,93.0,M,"cranial nerve 3 palsy. Ptosis of the left eye, it was completely shut; cannot hear; This is a spontaneous report from a contactable physician. A 93-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included atrial fibrillation, hypertension, hyperlipidaemia, diabetes, and chronic kidney disease. Concomitant medications were not reported. No additional vaccines administered on the same date of the vaccine and no prior vaccinations within 4 weeks. The reporter is the family's physician, who stated that the patient received the first dose of the Pfizer COVID vaccine on 22Jan2021 and three days later (25Jan2021), his left eye had ptosis - he was unable to open his left eye and it was completely shut. The patient came to him and when he would try to lift the eyelid up, it would just drop down. He then called a neuro ophthalmologist, he thought to himself that the patient could be having a stroke. The patient was sent to the Emergency Room and kept overnight to do CT of brain, MRI of brain, CT of orbits and MRI of neck. All tests came back normal, there was no stroke. The patient was discharged and was told to go see an ophthalmologist; the eye doctor diagnosed him with Cranial Nerve 3 Palsy. The reporter had read the consultation notes; the eye doctor ""wrote 1-2 days after he had COVID and had this happen"". The reporter clarified that the patient never had COVID, maybe this was a misunderstanding or typo with the doctor, but the patient just had the vaccine. The point is that the patient was diagnosed. The reporter further added that the patient can't hear, and so he will provide the patient's son's phone number. The reporter would like to know if this is a possible side effect of the vaccine and if he should receive the second dose of the vaccine as he is due in two days (Friday at 8:30AM on 12Feb2021). It was also reported that the ptosis has not gotten worse and has not resolved. The reporter added that the patient was admitted to the hospital for a full day. The patient underwent lab tests and procedures which included computerized tomography (CT) of the brain, CT of the neck, magnetic resonance imaging (MRI) of the brain and MRI of the orbits-all of which resulted normal in Feb2021. The events cranial nerve 3 palsy and 'Ptosis of the left eye, it was completely shut' had not resolved while the outcome of the rest of the events was unknown. Information on the batch/lot number has been requested.; Sender's Comments: By close temporal relationship, the company cannot completely exclude that the reported cranial nerve 3 palsy' is related to BNT162b2 administration, even though medical history including atrial fibrillation, hypertension, hyperlipidemia, diabetes, and chronic kidney disease, in the setting of elderly age, can be considered confounding factors in the overall clinical evaluation of this event occurred three days after the vaccination. Conversely, even though cannot be excluded as reportable event based on the information provided, the company deems there is not a reasonable possibility that the reported deafness is related to BNT162b2 administration, but, at the present time, evaluated as an intercurrent condition that cannot be also excluded as already present before the vaccination. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/22/2021,01/25/2021,3.0,OTH,,,Medical History/Concurrent Conditions: Atrial fibrillation; Chronic kidney disease; Diabetes; Hyperlipidemia; Hypertension,,,"['Computerised tomogram head', 'Computerised tomogram neck', 'Deafness', 'IIIrd nerve paralysis', 'Magnetic resonance imaging', 'Magnetic resonance imaging brain']",1,PFIZER\BIONTECH, 1056642,TN,20.0,F,"anaphylaxis; high blood pressure; elevated heart rate; her throat felt funny, like it was getting tight; very nauseous/sick of her stomach; rash on her chest; She could not swallow; This is a spontaneous report from a contactable consumer (parent of the patient). Information were received also from a Pfizer-sponsored program COVAX US Support. A 20-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9261), via an unspecified route of administration in the left arm on 05Feb2021 09:30 at single dose for COVID-19 immunisation. Medical history included acne, allergy environmental cats dogs and latex. Adrenaline (EPIPEN) and Corticosteroid were used to treat these allergies. Due to these severe allergies, the patient had to take weekly allergy shots. Got allergy shot the day before the 2nd vaccine shot. Concomitant medication included isotretinoin (AMNESTEEM), buspirone (unknown manufacturer), calcium (unknown manufacturer), azelastine hydrochloride, fluticasone propionate (DYMISTA), gabapentin (unknown manufacturer), melatonin (unknown manufacturer), omeprazole (unknown manufacturer), estrogens conjugated, medroxyprogesterone acetate (PREMELLA), probiotics (PROBIOTICS), fluoxetine hydrochloride (PROZAC) , trazodone (unknown manufacturer), colecalciferol (VITAMIN D), cetirizine hydrochloride (ZYRTEC). The patient previously took clindamycin, bactrim and corticosteroids and experienced hypersensitivity. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3249) intramuscular in left arm on 15Jan2021 at 11:00AM. It was reported that 15 minutes after receiving her second COVID-19 vaccine dose the patient developed anaphylaxis, her throat started closing up, her throat felt funny, like it was getting tight. A nurse administered her anaphylactic shot (EPI-PEN shot) and was taken to the hospital by ambulance. The patient was monitored in the Emergency Room because her blood pressure and heart rate were up, but the Emergency Room didn't give her any further treatment. The patient was discharged home on 05Feb2021. On Saturday, 06Feb2021, at 4-5AM she developed anaphylaxis again, the patient had the same throat tightening happen again. The mother gave her an Epi-Pen shot (AUVI-Q) and brought her back to the Emergency Room. While in the Emergency Room, the patient was given steroids and Pepcid, and then sent back home. On Sunday, 07Feb2021, at approximately 1:00AM she had the same throat tightening so the mother gave her an Epi-Pen shot (AUVI-Q) again, and brought her back to the Emergency Room. The patient was admitted to hospital and discharged on 09Feb2021 evening (at 16:00). At hospital the patient received some steroid shots in the hospital. The patient was given 3-125mg steroid shots, and 3-40mg steroid shots, every night she spent in the hospital, she woke up with her throat closing and she was administered 125 steroids 50 mg Diphenhydramine (BENADRYL) and 4-5 hours later 40 mg of steroids 20 mg Famotidine (PEPCID) IV. They kept IV fluids. On 10Feb2021 at 7:50AM the patient experienced throat tightness again. The mother gave her some Diphenhydramine (BENADRYL) and steroids which were prescribed at hospital. The patient started a taper dose of Prednisone 10mg tablets. She was to take 2 Prednisone 10mg tablets twice a day for 3 days, then to take 2 Prednisone 10mg tablets in the morning and 1 Prednisone 10mg tablet in the evening for 3 days; then to take 1 Prednisone 10mg tablet twice a day for 2 days, and then 1 Prednisone 10mg tablet daily for 2 days. The patient was prescribed generic Famotidine (PEPCID), 40mg, one tablet, twice a day, and generic Diphenhydramine (BENADRYL) 25mg capsules. On unknown date in feb2021 the patient gets very nauseous when her throat starts to close. She could not swallow and was sick of her stomach. She experienced a rash on her chest. The outcome of the event heart rate increased and blood pressure high was recovered, for anaphylactic reaction and throat tightness was not recovered. For the other events was unknown. The events anaphylaxis, throat tightness, heart rate increased and blood pressure were serious due to hospitalization.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/05/2021,02/01/2021,,PUB,AMNESTEEM; BUSPIRONE; CALCIUM; DYMISTA; GABAPENTIN; MELATONIN; OMEPRAZOLE; PREMELLA; PROBIOTICS; PROZAC; TRAZODONE; VITAMIN D [COLECALCIFEROL]; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Acne; Allergy to animals; Latex allergy,,,"['Anaphylactic reaction', 'Blood pressure measurement', 'Dysphagia', 'Heart rate', 'Heart rate increased', 'Hypertension', 'Nausea', 'Rash', 'Throat tightness']",2,PFIZER\BIONTECH, 1056643,TX,57.0,M,"shortness of breath; bad headaches; chest pain; rash on his neck and behind his ears; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number N5318), via an unspecified route of administration on 27Jan2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shortness of breath, bad headaches, chest pain and rash on his neck and behind his ears, all on an unspecified date in 2021. The events were all serious as they involved hospitalization from 02Feb2021 to 03Feb2021. Details were as follows: patient received the first dose of the vaccine on 27Jan2021; he had a lot of bad side effects and went to the hospital: shortness of breath, bad headaches, chest pain, rash on his neck and behind his ears. All this happened a few days after receiving the vaccine. He had an appointment with his cardiologist and he will have a cardiac catheter placed on 19Feb2021. The second dose of the vaccine was scheduled for 18Feb2021. The outcome of the events were unknown.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/27/2021,,,UNK,,,,,,"['Chest pain', 'Dyspnoea', 'Headache', 'Rash']",UNK,PFIZER\BIONTECH, 1056644,NJ,27.0,F,"Severe muscle pain; Itching in the left arm; rash in the left arm; cold sensation, like it was freezing; severe allergic reaction; Bell's Palsy; This is a spontaneous report from a contactable consumer (parent). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9262), via an unspecified route of administration in the left arm, on 23Jan2021 (at the age of 27-years-old) at a single dose for COVID-19 immunization. Medical history included Bell's Palsy (motor nerves involved) from 2017 to 2017. Concomitant medications included unspecified birth control. The patient had no prior vaccinations within four weeks of vaccination. The patient experienced Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction on an unspecified date. It was reported that the Bell's Palsy lasted 8 days and was considered a modified Bell's Palsy because it only sensorial nerves were involved. It was reported that the patient did not receive any treatment for Bell's Palsy. The clinical outcome of Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,,,UNK,,,Medical History/Concurrent Conditions: Bell's palsy (Motor nerves involved),,,"['Drug hypersensitivity', 'Facial paralysis', 'Feeling cold', 'Myalgia', 'Vaccination site pruritus', 'Vaccination site rash']",1,PFIZER\BIONTECH, 1056646,FL,71.0,F,"My arm hurt; I started to get little tired; I couldn't watch TV; My stomach suddenly did not feel well; Nauseous; I got cold; Sick; was very hot and so hot; was round up/she was feeling she would faint; waves of feeling like i would pass out; it was just being very hot, then being cold; Blood drained from my head, I just knew I was going to pass out; I took 0.2 rather than the 0.3ml of the first dose; very fast heart rate intermediately for many day; squeezing of chest; muscle hurting/Pain in my body in every muscles, my fingers, my hands, my calves, my feet, my back, neck, everything; digestive disorders; feeling gassy, uneasy; stomach abdomen was just tight; abdominal issue; feeling gassy, uneasy; stomach abdomen was just tight; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: E18982), on 21Jan2021 (at the age of 71-year-old) at single dose for COVID-19 immunisation. The patient reported that based on her history of reactions to medications, the nurses giving injections ""decided 0.2ml instead of 0.3ml"", which is what they gave, so she got 0.2 that is two-third of the shot. The 2nd shot was for 8'oclock on 11Feb2021. She is very sensitive to shots, vaccines, and to all medications and injections and things like that. She has sensitives thanks to two concussions she had in her life. She never was before that she had two concussions. Second one had a crazy man hit her after that just noticed that just have reactions not adverse or dying but definitely take rest of everything. So she take less of a shot, like a dental shot or cortisone shot, which she had taken in the past. If she has dental shot she cannot take Novocain, had to take Carbocaine or Marcaine and they give her half. Also she had been taking cortisone shot for shoulder for rotator cuff injury. They also have to give her less. Or flu shot: she takes half one week and come back for the other half the next week. Just have reactions. She told to when arrive for medication and did have one anaphylactic reaction but that was to cat skin dye, was told to this two nurses who was administering the vaccine and said to them she was really afraid to take. It is just too much for her. She knows her body. She is sure have reaction but is really afraid and don't know what is the first one will do to her. They just did two nurses and she decided that she will be taking 0.2 instead of 0.3ml which is what they gave. She got 0.2 so that two third of the shot and waited the half an hour, a nurse watched her card and 7 other cards. She did not have the anaphylactic reaction. She went home. Her arm hurt and started to get little tired. The events started the day that she got the shot. Like about 3 or 4 hours later. It is just few hours later she couldn't watch TV so went to laid down and an hour later she woke-up. She walked to her kitchen and blood drained from her head, she just knew she was going to pass out. Her stomach suddenly did not feel well. She tried to get back her bed but she was round up and as far as the bathroom. She got very nauseous, she laid down on bathroom floor. She thought she was sick but didn't round up having to use toilet of few times. Although while she was feeling she would faint. She was very hot and so hot. While lie down, she couldn't even pulling off her pajamas. So when she got cold so she was pulling a towel down and stop and she laid to for two hours, she finally got to her bed. It was a terrible experience. Next day she drank water and had potatoes prepared and went up eating back to later baked potatoes. Next day luckily she did not have repeat of the nausea. She didn't have that anymore of. She did have abdominal issue just not diarrhea or anything but just not feeling well, feeling gassy, so uneasy. This all lasted, that part lasted for 7 days. What concerned her was especially beside first day it was few days she got off again. She was just feel blood drain but not this first time she laid on floor. She couldn't sit on chair to watch TV for about 3 days. She mostly laid on bed but she would get very hot and then very cold during the day. She would get very fast heart beat not continue but really fast like heart was pounding her chest. She felt like someone has their hand inside her body squeezing her chest. She got afraid but didn't want to go hospital. She didn't think she was sick enough. She was concerned. So that was happened and this last was for about 7 days. Then the squeezing of chest part went away. She doesn't want to wind-up on the floor feeling that sick again, she felt so sick it felt like food poisoning. After that, it was just being very hot, then being cold, the fast heart rate, every muscle hurting. Those were the main things that continued for a week. And digestive disorders. It all lasted for about 13 days. She was concerned she had a very fast heart rate intermediately for many days, for about a week. And that's considered an adverse reaction and also she was getting waves of feeling like she would pass out, everything would drain from her head. She experienced stomach ache, feeling hot then cold. She wants to do precautions before taking the second dose on 11Feb2021. She did take may be 3 days later two Tylenol but didn't take anything (clarification requested). She didn't even take vitamins during that time. She was afraid to take anything so she did not. At the same time also there was pain in her body in every muscles, fingers, hands, calves, feet, back, neck, everything. Her stomach abdomen was just tight. She was concerned that last for few days. In last few days she started feel herself and now she is going again tomorrow. So that how she reacted. She doesn't know how much of this shot she told them she could tolerate because everybody is saying second shot will give you more reactions. All she can take this more than that because that was lot. She wants to be herself, don't want laying on floor, don't want to have 105 temperature or anything. The patient was asking if she should take another 0.2ml another two-third of the shot. She just asked them for half that is 0.15 would that be a big difference. She needed to know by 8 o'clock tomorrow. I might be in a queue to get it. She stated: 'So, that's my concern. I'm all alone, I'm a senior, I have no family. I lost my mother to covid. I know I need this vaccine, but I just, I cant get that sick and I'm so afraid I'll wind up with a 105 something, fainting away and no one knowing'. She was asking if reactions after the 2nd dose are worse than the 1st dose, if she didn't have anaphylaxis after 1st one, she shouldn't have it a 2nd time, right. She said, ""1st half of flu shot, I get sick, then the 2nd half nothing"". She also asked if she can take medications after the vaccine, like Tylenol, or irritable bowel syndrome (IBS) medication she takes as needed. The events resolved, but the patient reported it took her like 13 days before she felt better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Anaphylactic reaction to chemical (to cat skin dye); Concussion; Drug hypersensitivity; Irritable bowel syndrome; Rotator cuff injury,,,"['Abdominal pain upper', 'Abdominal symptom', 'Chest discomfort', 'Dizziness', 'Dyspepsia', 'Fatigue', 'Feeling cold', 'Feeling hot', 'Feeling of body temperature change', 'Flatulence', 'Heart rate', 'Heart rate increased', 'Illness', 'Loss of consciousness', 'Myalgia', 'Nausea', 'Pain in extremity', 'Presyncope', 'Underdose', 'Visual impairment']",1,PFIZER\BIONTECH, 1056647,IN,66.0,M,"Both legs from knees down got swollen and were painful to touch, walk on, etc.; Both legs from knees down got swollen and were painful to touch, walk on, etc.; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EX923, in hospital, via an unspecified route of administration in left arm from 19Jan2021 at 20:45 (at age of 66 years) at single dose for COVID-19 immunization. Medical history included spinal stenosis, arthritis and allergy to penicillin, all from an unknown date. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medication included gabapentin, meloxicam (MOBIC), zinc, ascorbic acid (VIT C), magnesium and cinnamomum verum stem bark/elettaria cardamomum fruit/syzygium aromaticum (CINNAMOL). On 24Jan2021 at 16:00 both patient's legs from knees down got swollen and were painful to touch, walk on, etc. The event resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with steroids. The reported events were resolving at the time of the report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/24/2021,5.0,PVT,GABAPENTIN; MOBIC; ZINC; VIT C; MAGNESIUM; CINNAMOL,,Medical History/Concurrent Conditions: Arthritis; Penicillin allergy (known_allergies: penicillan); Spinal stenosis,,,"['Pain in extremity', 'Peripheral swelling']",UNK,PFIZER\BIONTECH, 1056648,NY,82.0,F,"some pain in my left shoulder; severe pain in my lower back; significant nausea; This is a spontaneous report from a contactable physician (patient). An 82-year-old female patient received second dose of bnt162b2 (BNT162B2) , via an unspecified route of administration on 10Feb2021 12:00 at single dose on right arm for covid-19 immunisation. Medical history included ongoing allergy to perfumes/scents, ongoing allergy to linseed oil, ongoing chronic osteoarthritis (six joint replacements), GERD, hypertension. Concomitant medication included duloxetine hydrochloride (CYMBALTA), enalapril, ferrous sulfate, gabapentin. The patient previously received first dose of bnt162b2 on 20Jan2021 11:00 for covid-19 immunisation and experienced no adverse event. The patient stated that, ""I had no reaction, not even a sore arm, after the first shot. However, for two days (Feb2021) so far after the second shot I have severe pain in my lower back, some pain in my left shoulder, and significant nausea."" No treatment received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant at the time of vaccination. The outcome of the events was not resolved. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/01/2021,,SEN,CYMBALTA; ENALAPRIL; FERROUS SULFATE; GABAPENTIN,Food allergy; Osteoarthritis (Chronic osteoarthritis (six joint replacements)); Perfume sensitivity,Medical History/Concurrent Conditions: GERD; Hypertension; Joint replacement,,,"['Arthralgia', 'Back pain', 'Nausea']",2,PFIZER\BIONTECH, 1056649,CT,32.0,M,"Joint pain in arm, shoulder, hip, and leg on side of injection site; joint pain in arm, shoulder, hip, and leg on side of injection site; Joint pain in arm, shoulder, hip, and leg on side of injection site; fever of 99.8 F; Headache; Constipation; Sweating, so much sweating; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 10Feb2021 (13:00) (at the age of 32years) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL3247), via an unspecified route of administration on 20Jan2021 (12:00PM) (at the age of 32years) for COVID-19 immunization. The patient has no medical history; no allergies to medications, food, or other products. Concomitant medication included vitamin B complex (VITAMIN B) also reported as ""B vitamin supplement"" taken from an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021, the patient experienced joint pain in arm, shoulder, hip, and leg on side of injection site. The patient woke up with fever of 99.8 F that ended approximately 03:00 PM on 11Feb2021. The patient also experienced headache, constipation and sweating, so much sweating. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of event fever was recovered on 11Feb2021; the outcome of other events was recovered on an unspecified date. This case is non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,WRK,VITAMIN B,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Arthralgia', 'Body temperature', 'Constipation', 'Headache', 'Hyperhidrosis', 'Pyrexia', 'Vaccination site joint pain', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1056651,CA,74.0,F,"blood sugar level is over 400; This is a spontaneous report from a contactable consumer who reported for herself. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN5318) on 09Feb2021 at 15:00 (at 74 years) at single dose in left arm for covid-19 immunisation. Medical history included type 2 diabetes mellitus, high blood pressure. Concomitant medication included metformin and diphenhydramine hydrochloride (LURISPAN). Patient was not pregnant.The patient previously took epinephrine and had drug allergy. The patient blood sugar level was over 400 on 10Feb2021. No treatment given for the event. The final outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/10/2021,1.0,PUB,METFORMIN; LURISPAN,,Medical History/Concurrent Conditions: Blood pressure high; Type II diabetes mellitus,,,"['Blood glucose', 'Blood glucose increased']",1,PFIZER\BIONTECH, 1056652,FL,,M,"chest pains; Ejection fraction decreased (from 40 down to 20); This is a spontaneous report from a Pfizer-sponsored program ""Covax US Support""received from a contactable consumer reporting for himself. A male patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation. The patient experienced chest pains and ejection fraction decreased (from 40 down to 20) both on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included ejection fraction: from 40 down to 20 on unknown date. The events were considered serious as caused patient's hospitalization. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,"['Chest pain', 'Ejection fraction', 'Ejection fraction decreased']",2,PFIZER\BIONTECH, 1056653,,,F,"pneumonia; pneumonia; This is a spontaneous report from a contactable consumer (patient's son) An 84-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date with outcome of unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Drug ineffective', 'Pneumonia']",2,PFIZER\BIONTECH, 1056654,FL,,M,"ok to get the 2nd dose if he tested positive after the first dose.; ok to get the 2nd dose if he tested positive after the first dose.; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was scheduled for 2nd shot on 13Feb2021; asked if it is ok to get the 2nd dose if he tested positive after the first dose on an unknown date. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1056655,TX,,F,"Aspiration pneumonia; This is a spontaneous report from a Pfizer sponsored program from a contactable pharmacist. A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, in Jan2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 09Feb2021, the patient experienced aspiration pneumonia but no fever and on antibiotic. Clinical outcome was unknown at time of this report. The information on the lot number has been requested.; Sender's Comments: Event aspiration pneumonia represents a coincidental medical condition unrelated to the vaccine use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,02/09/2021,39.0,UNK,,,,,,['Pneumonia aspiration'],1,PFIZER\BIONTECH, 1056656,FL,65.0,F,"blew a blood vessel under her eye lid; stroke; tasted rubber band taste in her mouth; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN5318), in a clinic, intramuscularly in the right arm on 29Jan2021 at 14:00 at 65-years-old at a single dose for COVID-19 immunization. There were no prior vaccinations within four weeks of the bnt162b2. Medical history included ongoing fibromyalgia from an unknown date, reflex sympathetic dystrophy from an unknown date and unknown if ongoing, irregular heart beat from an unknown date and unknown if ongoing, ongoing hemangioma from an unknown date, thyroid problems from an unknown date and unknown if ongoing, low white blood cell counts from an unknown date and unknown if ongoing, ongoing pinched nerves in her neck and back from an unknown date, migraines from an unknown date and unknown if ongoing, diastolic heart failure from an unknown date and unknown if ongoing (diagnosed about 5 years ago.), abdominal pains from an unknown date and unknown if ongoing, numbness in her nose, foot from an unknown date and unknown if ongoing, nausea from an unknown date and unknown if ongoing, vomiting from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1283) for COVID-19 immunization on 08Jan2021 at 64-years-old and experienced metallic taste (Recovered), carbamazepine (TEGRETOL) from an unknown date to an unknown date and experienced white count was down to 1, influenza vaccine (MANUFACTURER UNKNOWN) in Jul2020 at 64-years-old for immunization. The patient experienced the following events and outcomes: stroke (medically significant) on 29Jan2021 at 14:10 with outcome of unknown, blew a blood vessel under her eye lid (medically significant) on 31Jan2021 with outcome of recovering, tasted rubber band taste in her mouth (non-serious) on 29Jan2021 with outcome of unknown. The clinical course was reported as follows: The patient reported a history of migraines/ weather migraines, that cause numbness in nose and foot as well as gastro-intestinal symptoms. The patient received her first dose of the Pfizer COVID vaccine on 08Jan2021 and felt a metallic taste in her mouth (said that the metallic taste lasted about three hours; ate to get rid of the metallic taste). On 29Jan2021, the patient received her second dose; after 10 minutes her face went numb; her nose, forehead, and under her eyes all the way up felt numb. Also, the patient's systolic blood pressure was at 150. The patient reported that she also tasted rubber band taste in her mouth. The patient's neighbor that was there with her getting the vaccine told the nurse and they called the paramedics. The paramedics stated that they thought she had a stroke. She said that her blood pressure was 150 systolic (usually 107-110/79). The patient had diastolic heart failure which was diagnosed about 5 years prior. The numbness stayed with her until about 22:00 on 29Jan2021. The patient had a history of ""migraines and gets abdominal pains, numbness in her nose, foot"", and she experienced ""nausea and vomiting and stuff with her migraines."" The patient thought the vaccine just gave her a big migraine. The patient took sumatriptan succinate (IMITREX) and it did nothing. The patient said that on 31Jan2021 her eye felt weird. The patient blew a blood vessel under her eye lid. The patient's eye looked like a blood clot in the corner of her eye then it dispersed throughout the eye and then now it was just below the pupil of her eye. The patient called the doctor on 01Feb2021, but they were out because of the snow. On 02Feb2021, the patient received a call from the doctor's office saying that the physician assistant would call her back, but the patient had not heard anything yet. The blood circulated around her eye and now it was just only under her pupil. The patient said that her daughter sent her something that said that some people have gotten Bell's palsy after getting the vaccine. The patient said that she was concerned about this with the facial numbness. The patient said that every once in a while, her face felt weird; her cheeks feel weird and her nose. The patient said that it comes and goes. The day after she got the second shot, she felt like she got run over by a truck and like someone beat her up. The patient's migraines were under control with magnesium. The migraine came on so quick it was like a boom. The patient said that was why she was concerned. The patient said that she declined going to the hospital; and there was no trip to the emergency room or physician office. The patient underwent lab tests and procedures which included blood pressure: 150 systolic on 29Jan2021 (usually 107-110/79). Therapeutic measures were taken as a result of stroke.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,OTH,,Fibromyalgia; Hemangioma; Pinched nerve,Medical History/Concurrent Conditions: Abdominal pain; Diastolic heart failure (diagnosed about 5 years ago.); Heart rate abnormal; Migraine; Nausea; Numbness; Reflex sympathetic dystrophy; Thyroid disorder; Vomiting; White blood cell count decreased,,,"['Blood pressure systolic', 'Cerebrovascular accident', 'Eye haemorrhage', 'Taste disorder']",UNK,PFIZER\BIONTECH,OT 1056657,CA,71.0,M,"10 days after 1st dose patient suffers ischemic stroke 4 days later the patient suffered a seizure; 10 days after 1st dose patient suffers ischemic stroke 4 days later the patient suffered a seizure; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 23Jan2021 at 08:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included Parkinson's disease, dementia, Post-traumatic stress disorder, high blood pressure and high cholesterol. Concomitant medication were not reported. It was mentioned other vaccine on 28Jan2021, but no further information provided. On 02Feb2021 at 12:00 am, 10 days after 1st dose of BNT162B2 patient experienced ischemic stroke and 4 days later the patient suffered a seizure. The events resulted in 6 days of hospitalization. At the time of the reporting the patient was recovering from events. Information about lot/ batch number has been requested",Not Reported,,Yes,Yes,6.0,Yes,N,01/23/2021,02/02/2021,10.0,MIL,,,Medical History/Concurrent Conditions: Blood pressure high; Dementia; High cholesterol; Parkinson's disease; Post-traumatic stress disorder,,,"['Ischaemic stroke', 'Seizure']",1,PFIZER\BIONTECH, 1056658,FL,60.0,M,"loss of vision in right eye; a left occipital lobe intraparenchyma hemorrhage; acute subdural hemorrhage posterior left tentorial; headache; This is a spontaneous report from a contactable consumer who reported for himself. A 60-Year-old Male patient received his second single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine, lot number EN5318) in right arm, 15:00 on 15Feb2021 for COVID-19 immunization. First shot was received 03:00PM on 27Jan2021 at right arm (lot EL3247). Medical history included end stage renal disease (ESRD), hypertension (HTN), coronary artery disease (CAD). Patient had known allergies to Lisinopril and Norvasc. Concomitant medications in two weeks included hydralazine, metoprolol, acetylsalicylic acid (ASPIRIN), clopidogrel bisulfate (PLAVIX), and atorvastatin calcium (LIPITOR). The patient developed severe headache and loss of vision in right eye on 16Feb2021 (day post vaccine), started at 09:00 PM. CT scan showed a left occipital lobe intraparenchyma hemorrhage and 1-acute subdural hemorrhage posterior left tentorial. The patient received unspecified treatment on ICU admission. The events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Nasal Swab was performed on 19Feb2021 and 20Feb2021 and no result was provided. The patient had not recovered from the events.",Not Reported,,Yes,Yes,,Yes,N,02/15/2021,02/16/2021,1.0,UNK,HYDRALAZINE; METOPROLOL; ASPIRIN [ACETYLSALICYLIC ACID]; PLAVIX; LIPITOR [ATORVASTATIN CALCIUM],,Medical History/Concurrent Conditions: Coronary artery disease (CAD); End stage renal disease (ESRD) (ESRD); Hypertension (HTN),,,"['Blindness', 'Cerebral haemorrhage', 'Computerised tomogram', 'Headache', 'SARS-CoV-2 test', 'Subdural haemorrhage']",2,PFIZER\BIONTECH, 1056659,NJ,,M,"heart issue; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient passed away after taking the vaccine. He was healthy but developed heart issue after taking vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: heart issue",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Cardiac disorder'],UNK,PFIZER\BIONTECH, 1056660,CA,73.0,M,"Cardiac Event MI or Stroke; Cardiac Event MI or Stroke; This is a spontaneous report from a contactable consumer (Son in law). A 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 17Feb2021 14:00 at single dose for covid-19 immunisation. Medical history included atrial fibrillation (AFib), prostate cancer Survivor. Concomitant medication included alirocumab (PRALUENT), escitalopram oxalate (LEXAPRO), apixaban (ELIQUIS), nitroglycerin and Ca channel blocker. The patient received the first dose of BNT162B2 on an unknown date for covid-19 immunisation. The patient experienced cardiac event myocardial infarction (MI) or stroke on 17Feb2021. Adverse event result in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The patient died on 19Feb2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. The reporter didn't know if this was associated or not. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cardiac Event MI or Stroke; Cardiac Event MI or Stroke",Yes,02/19/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,UNK,PRALUENT; LEXAPRO; ELIQUIS; NITROGLYCERIN,,Medical History/Concurrent Conditions: AFib; Prostate cancer (Survivor),,,"['Cerebrovascular accident', 'Myocardial infarction']",2,PFIZER\BIONTECH, 1056661,NJ,71.0,M,"bleeding through bandage (ceased quickly); pain at needle insertion; cold/chill sensation at injection site; very large bruise at injection site; residual discomfort at injection site; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm from 15Jan2021 at 13:00 at 71-years-old at a single dose for COVID-19 immunization; administered at a Nursing Home/Senior Living Facility. The patient's medical history was reported as none. Concomitant medications included finasteride (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN), tamsulosin (MANUFACTURER UNKNOWN), vitamins nos (MULTIVITAMIN [VITAMINS NOS]); all taken for an unspecified indication from an unspecified date to an unspecified date; received within two weeks of the vaccine. On 15Jan2021 at 13:00, the patient experienced: bleeding through bandage (ceased quickly) (medically significant), pain at needle insertion (non-serious), cold/chill sensation at injection site (non-serious), very large bruise at injection site (non-serious), residual discomfort at injection site (non-serious); with no treatment received . The clinical course was reported as follows: The patient's concern was whether these issues affect the efficacy of the injection. The patient wanted to know if the vaccine was administered incorrectly. The patient wanted to know if he should be concerned about the continuing discomfort. The patient reported that he received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN9581), via an unspecified route of administration in the right arm from 05Feb2021 at 13:00 at 71-years-old at a single dose for COVID-19 immunization; and there was no reaction whatsoever to the second injection (other than slight arm discomfort; none of the above-described issues). The patient underwent lab tests and procedures which included Nasal Swab (SARS-CoV-2 test): negative on 19Jan2021, negative on 26Jan2021, negative on 02Feb2021, unknown results-pending on 09Feb2021. The clinical outcome of the events was recovered with sequelae (""recovered with lasting effects"") on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,SEN,FINASTERIDE; PRAVASTATIN; TAMSULOSIN; MULTIVITAMIN [VITAMINS NOS],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Haemorrhage', 'SARS-CoV-2 test', 'Vaccination site bruising', 'Vaccination site coldness', 'Vaccination site discomfort', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1056662,NV,95.0,F,"Vaccine induced severe ITP; This is a spontaneous report from a contactable Other HCP. A 95-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration in right arm on 29Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included rectal cancer from 1998 (S/P AP resection, cured), Abdomino-perineal resection of rectum from an unknown date, Sulfonamide allergy. No Covid prior vaccination. There were no concomitant medications. Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two week. The patient previously took amikacin sulfate (NOVACIN) and experienced drug allergy. In 2021, patient developed multiple ecchymotic/purpuric skin lesions on extremeties and trunk 1-2 weeks after vaccination. Platelet count 9k. No anemia. Normal WBC. Oncologist diagnosis vaccine induced severe ITP (Idiopathic thrombocytopenic purpura). Admitted to Hospital 20Feb2021. Ongoing treatment. The patient was hospitalized for the events from 20Feb2021 to 25Feb2021 for 5 days hospitalisation. No Covid tested post vaccination. AES resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. The patient underwent lab tests and procedures which included platelet count: 9k in 2021, white blood cell count: normal in 2021. Therapeutic measures were taken as a result of events (IV Decadron, IVIG). The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of idiopathic thrombocytopenic purpura due to temporal relationship. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Yes,Yes,5.0,Not Reported,U,01/29/2021,,,UNK,,,"Medical History/Concurrent Conditions: Abdomino-perineal resection of rectum; Rectal cancer (S/P AP resection, cured); Sulfonamide allergy",,,"['Immune thrombocytopenia', 'Platelet count', 'White blood cell count']",UNK,PFIZER\BIONTECH, 1056663,,,U,"Diarrhea; This is a spontaneous report from a consumer (patient). A patient of unspecified age and gender received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Feb2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea on 18Feb2021 with outcome of unknown. The patient asked how long should patient tolerate diarrhea? What was the next step? When offered the contact number for Pfizer Medical Information, the patient stated ""I would be dead by then, you don't know?"". The information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,UNK,,,,,,['Diarrhoea'],1,PFIZER\BIONTECH, 1056664,NC,69.0,F,"his wife had blood in her stool, but his wife thinks the blood may be from hemorrhoids; his wife developed bad diarrhea; Gastrointestinal pain; This is a spontaneous report from a contactable consumer reporting for his wife. A 69-years-old female patient receive the first dose of bnt162b2 (BNT162B2; Lot # EL9262) vaccine , via an unspecified route of administration in the left arm, on 30Jan2021 13:30 at single dose for Covid-19 immunisation . Medical history included clostridium difficile infection 4 or 5 years ago , haemorrhoids. The patient's concomitant medications were not reported. The patient had blood in her stool, but she thinks the blood may be from hemorrhoids on 09Feb2021 with outcome of unknown , his wife developed bad diarrhea on 04Feb2021 with outcome of not recovered , gastrointestinal pain on 04Feb2021 with outcome of not recovered. Hematochetia was considered an Important Medical Event. Course of the event. The reporter said approximately 4-5 days later (Thursday, 04Feb2021), his wife developed bad diarrhea. He said his wife was tested negative for bacteria and virus in her blood. He said his wife still has the diarrhea. He said his wife provided a stool sample to her GI doctor's office yesterday, 10Feb2021, and his wife's stool is being checked for everything. He said his wife has been having 2-3 bowel movements per day. He said the day-before-yesterday (09Feb2021), his wife had blood in her stool, but his wife thinks the blood may be from hemorrhoids. He said his wife has had hemorrhoids before, and her recurring diarrhea has brought the hemorrhoids out. He said his wife has ongoing gastrointestinal pain, as well. Follow up information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/04/2021,5.0,PVT,,,Medical History/Concurrent Conditions: Clostridium difficile infection (4 or 5 years ago.); Hemorrhoids,,,"['Diarrhoea', 'Gastrointestinal pain', 'Haematochezia']",1,PFIZER\BIONTECH, 1056665,,80.0,F,"her very ill after the 2nd shot; Patient had COVID-19 and received COVID-19 vaccine; Patient had COVID-19 and received COVID-19 vaccine; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received the second dose of (at the age of 80-year-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: not known), via an unspecified route of administration on unspecified date at SINGLE DOSE for COVID-19 immunization. Medical history included ongoing COVID-19. Concomitant medication included apixaban (APIXABAN) from unknown dates and indications. The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on an unknown date and the patient experienced COVID-19. It was stated that the patient had COVID-19 and received COVID-19 vaccine which made her very ill on an unknown date after the 2nd shot. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,APIXABAN,COVID-19,,,,"['Malaise', 'Off label use', 'Product use issue']",2,PFIZER\BIONTECH, 1056666,GA,31.0,F,"Light cough; Shortness of breath; Anaphylaxis; lost voice entirely; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 11Feb2021 at 13:15, at single dose, for COVID-19 immunisation. Medical history was none. Patient did not have known allergies and did not have COVID-19 prior to vaccination. Concomitant medications included piroxicam (PAXIL) and lisdexamfetamine mesilate (VYVANSE). Patient did not receive other vaccines in four weeks. The patient experienced light cough on 11Feb2021 at 14:45 with outcome of recovering, shortness of breath on 11Feb2021 with outcome of recovering, anaphylaxis on 11Feb2021 with outcome of recovering, lost voice entirely on 11Feb2021 with outcome of recovering. The events required emergency room visit and physician office visit. The patient was hospitalized due to the events in Feb2021 for 1 day. Events were considered life threatening. Clinical course: light cough after half an hour from vaccination. Within 2 to 3 hours had lost voice entirely and was suffering from shortness of breath. Her primary physician told her to go to the emergency room or he was calling an ambulance because he said it sounded like anaphylaxis and that her life was in danger. Therapeutic measures were taken as a result of the events and included treatment with intravenous (IV) Decadron Pepcid and epinephrine. She received the 2nd dose on 21Feb2021 at 01:15 PM. Patient was not tested for COVID-19 post vaccination. The information on the lot/batch number has been requested.",Not Reported,,Yes,Yes,1.0,Not Reported,N,02/11/2021,02/11/2021,0.0,PHM,PAXIL; VYVANSE,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Anaphylactic reaction', 'Aphonia', 'Cough', 'Dyspnoea']",1,PFIZER\BIONTECH, 1056667,FL,78.0,F,"hearing totally gone/complete hearing loss in left ear; tinnitus in ears and feeling of pressure; tinnitus in ears and feeling of pressure; Didn't make a real issue out of it and thought it was just congestion; This is a spontaneous report from a contactable consumer. A 78-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 in left arm at 11:15 at single dose for COVID-19 immunisation at the age of 78-year-old. Lot number was E18982. Medical history and concomitant medications were unknown. Historical vaccination included flu in Jan2021 for immunization. On 08Feb2021, the patient woke up with complete hearing loss in left ear, hearing totally gone, tinnitus in ears and feeling of pressure. In Feb2021, the patient did not make a real issue out of it and thought it was just congestion. On 08Fb2021, the patient saw ENT. On 08Feb2021, the patient performed a hearing test: complete hearing loss. On unknown date, blood work was performed, and the results were unknown. The patient did not recover from woke up with complete hearing loss in left ear/ hearing totally gone, tinnitus in ears and feeling of pressure, the outcome of nasal congestion was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,02/01/2021,12.0,UNK,,,,,,"['Acoustic stimulation tests', 'Blood test', 'Deafness', 'Ear discomfort', 'Nasal congestion', 'Tinnitus']",1,PFIZER\BIONTECH, 1056668,TN,70.0,F,"She has high blood pressure; she developed Afib; This is a spontaneous report from a contactable consumer reporting for herself. A 70-years-old female patient received bnt162b2 (BNT162B2; Lot # EN5318) vaccine, via an unspecified route of administration on 25Jan2021 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient developed atrial fibrillation on 29Jan2021 with outcome of unknown , she has high blood pressure on an unspecified date with outcome of unknown. The patient laid down and she could feel her heart beating real fast. She has high blood pressure so she went to taking her blood pressure and her heart rate was like 100. On Sunday night of that week it got worse and her blood pressure got higher so she called 911 and they took to the ER. She says this was her first ever episode with Afib she never had it before this. The patient was treated with metoprolol and rivaroxaban (XARELTO). The patient underwent lab tests and procedures which included blood pressure measurement: high and heart rate: heart rate was like 100. Both the reported events were considered serious because Important Medical Events. Follow up information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/29/2021,4.0,UNK,,,,,,"['Atrial fibrillation', 'Blood pressure measurement', 'Heart rate', 'Hypertension']",UNK,PFIZER\BIONTECH, 1056669,NV,,U,"She knows one person did die; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter mentioned that 'she knows one person did die' on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: She knows one person did die",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],UNK,PFIZER\BIONTECH, 1056686,,65.0,M,"Patient hospitalized due to fevers, hypoxia to mid 70s, severe fatigue and lethargy which developed within hours of receiving vaccine.",Not Reported,,Yes,Yes,,Not Reported,U,02/24/2021,02/25/2021,1.0,UNK,,,"ESRD, Heart Failure, Coronary artery disease, HIV, HBV co-infection",,,"['Fatigue', 'Hypoxia', 'Lethargy', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1056747,OH,34.0,F,Approximately 36 hours after second dose- patient went into late preterm labor of 36w6d. Infant was born weighing 6lbs 3.8oz on 2/21/21. Due date was 3/14/21.,Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/18/2021,02/20/2021,2.0,PVT,Omeprazole Prenatal vitamins,Shingles,,,Blackberries,"['Exposure during pregnancy', 'Live birth', 'Pregnancy', 'Premature labour']",2,PFIZER\BIONTECH,IM 1056787,FL,61.0,F,"Liquid began leaking down arm; Liquid leaked down arm; Shot was given in top layer of skin; A spontaneous report was received from a consumer, concerning a 61-years-old, female patient who was administered Moderna's COVID-19 vaccine and reported that Liquid began leaking down arm (Vaccination site discharge), Liquid leaked down arm (Underdose) and Shot was given in top layer of skin (Incorrect route of product administration). The patient's medical history included asthma. Concomitant medications were not provided. On 10-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection. Patient reported that the shot did not feel intramuscular, patient thinks the shot was given in the top layer of skin. After patient received the dose immediately liquid began leaking down her arm, which the patient believes was the Moderna Dose that should have gone in her arm. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, Liquid began leaking down arm, Liquid leaked down arm and Shot was given in top layer of skin was considered as resolved; Reporter's Comments: This report refers to a case of vaccination site discharge, underdose, and incorrect route of product administration for mRNA-1273 (lot # unknown), with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,UNK,,Asthma,,,,"['Incorrect route of product administration', 'Underdose', 'Vaccination site discharge']",1,MODERNA,OT 1056788,NC,,F,"A lot of leakage as dose was being administered/ dripped up to her fingers; Syringe was cracked; A spontaneous report was received from a consumer, concerning 32-year-old of old female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and where a lot of leakage as dose was being administered/ dripped up to her fingers as syringe was cracked. The patient medical history was not reported. Concomitant medication was not reported. On an unspecified date, prior to onset of events the patient received first of two planned doses of vaccine (batch: unknown) for prophylaxis of COVID-19 infection. On17-Feb-2021, the patient received second of two planned doses of vaccine (batch no unknown) for prophylaxis of COVID-19 infection. On 17-Feb-2021 the patient experienced a lot of leakage happened in second dose. It dripped up to her fingers as syringe was cracked. Treatment taken information was not reported. Action taken in to (mRNA-1273) COVID-19 in response to events were not reported. The outcome of events a lot of leakage as dose was being administered/ dripped up to her fingers as syringe was cracked were considered resolved on 170-Feb-2021.; Reporter's Comments: This report refers to a case of Product administration error - Incorrect dose administered and Syringe issue for mRNA-1273, lot # unknown, with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Incorrect dose administered', 'Syringe issue']",2,MODERNA,OT 1056789,MN,,F,"17 years old and was mistakenly given the Moderna vaccine; A spontaneous report was received from a consumer, concerning a 17 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced product administered to patient of inappropriate age. The patient's medical history was not provided. No concomitant medications were reported. On 28 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown), in left non-dominant arm for prophylaxis of COVID-19 infection Caregiver said that daughter got the vaccine at her workplace and now they refusing to give her the second dose because she is under 18 years old. The workplace had the second dose on 25Jan2021. Action taken with second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, product administered to patient of inappropriate age, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 17-year-old female who experienced nonserious unexpected event of Product administered to patient of inappropriate age for mRNA-1273 (lot # unknown) without associated adverse events. The event occurred the same day as the first dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1056790,NC,,M,"16 Year old boy accidentally got Moderna shot; A spontaneous report was received from consumer, concerning her son, a 16 years old male patient who accidentally received Moderna's covid-19 vaccine (mRNA-1273). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 22 Feb 2021, the patient received first of two planned doses of mRNA-1273 (lot no:024M20A) intramuscularly for prophylaxis of covid-19 infection. On 22 Feb 2021, a 16-year-old boy accidentally got Moderna vaccine shot. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event 16-Year-old boy accidentally got Moderna shot was considered recovered on 22 Feb 2021.; Reporter's Comments: This report refers to a case of a 16-year old male patient who accidentally received Moderna's covid-19 vaccine (mRNA-1273) lot # 024M20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1056791,CA,33.0,M,"Vaccination card says use the vaccine by 2/18/2021; A spontaneous report was received from a consumer concerning a 33-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and vaccination card says use the vaccine by 18 Feb 2021. No relevant concomitant medications were reported. On 19 Feb 2021, approximately 1 day prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (007M20A) intramuscularly for prophylaxis of COVID-19 infection. Vaccination card says use the vaccine by 18 Feb 2021 (expired vaccine used). No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event vaccination card says use the vaccine by 18 Feb 2021 was considered resolved.; Reporter's Comments: This report refers to a case of Expired product administered for mRNA-1273 (lot # 007M20A), with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Expired product administered'],1,MODERNA,OT 1056792,OH,94.0,F,"nausea; takes an anticoagulant; A spontaneous report was received from a consumer concerning a 94-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea and contraindicated product administered. The patient's medical history was not provided. Concomitant medications included warfarin. On 24-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot unknown) in the right arm for prophylaxis of COVID-19 infection. On 25-Jan-2021, the patient experienced nausea. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, nausea, was unknown. The outcome of the event, contraindicated product administered, was considered recovered/resolved.; Reporter's Comments: This case concerns a 94-year old female patient who received mRNA-1273 and experienced non-serious event nausea and contraindicated product administered. Based on the current available information and temporal association between the use of the product and the start date of nausea, a causal relationship cannot be excluded. The event contraindicated product administered is assessed as not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/24/2021,01/24/2021,0.0,UNK,WARFARIN,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Contraindicated product administered', 'Nausea']",1,MODERNA,OT 1056838,IL,30.0,M,Patient recieved dose on 2/16/21. Diagnosed with febrile hemolytic anemia in the setting of hereditary spherocytosis in remission after 1st dose of Pfizer COVID-19 mRNA,Not Reported,,Not Reported,Yes,7.0,Not Reported,N,02/16/2021,02/19/2021,3.0,PVT,,,Spherocytosis,,None,"['Haemolytic anaemia', 'Hereditary spherocytosis', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1056842,FL,78.0,F,"The medical facility did not treat patient as her primary care, but were informed that she passed away on 15 February 2021 of a stroke. I do not have further information on the medical aspect of this as we were not her treating provider but did administer the vaccine on 12 February.",Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,,02/11/2021,02/15/2021,4.0,MIL,,,,,,"['Cerebrovascular accident', 'Death']",1,MODERNA,IM 1056845,OH,87.0,F,"Three days after second COVID-19 vaccine, patient became lethargic. Due to advance directive that instructed that no life saving interventions to take place, patient continued to decline and expired on 29 January 2021.",Yes,01/29/2021,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/23/2021,3.0,SEN,Medical records are on file at facility. Executor of the patient will grant FDA access to medical records.,"Patient diagnosed with COVID-19 on 25 November. Mild symptoms. Tested negative within two weeks. Patient had significant Alzheimer's disease, but not life threatening. Other co-morbid conditions that were managed through medication. Facility administered first dose of COVID-19 shortly after Christmas and second dose on 29 January.",See above. Recommend FDA contact facility for medical records.,,,"['Blood creatinine increased', 'Death', 'General physical health deterioration', 'Laboratory test abnormal', 'Lethargy']",2,PFIZER\BIONTECH,IM 1056850,NY,51.0,M,"At about 2am on 2/10/21, Patient got up from bed and fell down a flight of stairs. He was initially bleeding and unconscious and was brought by EMS to the hospital. Upon arrival at the hospital he had a temperature of 40 C. He was found to have 2 small left temporal hemmorhagic contusions on CT scan. He had a seizure during the hospitalization. He was initially treated for HSV encephalitis but it is not clear if that was confirmed. The hospital team may not have known of the recent vaccination. He improved during the hospitalization, but remained with a very unsteady gait. He could not return to the group home. He was transferred to a rehab facility to receive PT on 02/16/2021. He remains at rehab. Prior to the fall, on the 3rd day after vaccination, on 2/8/21 at about 10 am, the patient coughed and had a small blood on the inside of his face mask while at his day program. He was seen by his PCP and had no abnormal findings. He had a CBC, BMP and CXR and all were unremarkable.",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,02/05/2021,02/10/2021,5.0,OTH,"Depkote, Zyprexa, Ativan, Prozac, Topamax, amlodipine, ASA",None,"Mild intellectual disability, impulse contorl disorder, chronic self-excoriation, nephrolithiasis,",,no known allergies,"['Body temperature increased', 'Brain contusion', 'Chest X-ray normal', 'Computerised tomogram', 'Encephalitis', 'Fall', 'Full blood count normal', 'Gait disturbance', 'Haemoptysis', 'Haemorrhage', 'Herpes simplex encephalitis', 'Loss of consciousness', 'Lumbar puncture', 'Metabolic function test normal', 'Seizure']",UNK,PFIZER\BIONTECH,IM 1056852,MI,78.0,F,"Admitted to hospital for acute on chronic respiratory failure following covid vaccination. (patient significantly fatigued, slept most of the day after vaccine, not on BIPAP as needed) HISTORY OF PRESENT ILLNESS: patient is a 78 y.o. female with a history of oxygen-dependent chronic obstructive pulmonary disease, obstructive sleep apnea, and persistent atrial fibrillation who presents today with general malaise. She received her 2nd COVID-19 vaccination yesterday and complained of fatigue, body aches, and general malaise all day. Later in the evening she noticed that her blood oxygen level was low. She denies having any more shortness of breath abnormal. She has had no vomiting, headache, or chest pain. On arrival she was noted to be febrile and required 6 L supplemental oxygen via nasal cannula. She usually uses 2 L nasal cannula at baseline, occasionally increasing it to 3 or 4 with exertion. She also had elevated troponin levels and noted leukocytosis. There was radiographic evidence of congestive heart failure. On exam, she is tired and wants to go to sleep. She is still requiring 4 L of oxygen via nasal cannula. Her daughter is at bedside. Plans are discussed for admission and she is agreeable. ASSESSMENT / PLAN: * Acute on chronic hypoxemic respiratory failure (HCC) Assessment & Plan Admit to medicine- hypoxic requiring 6 L nasal cannula, utilizes 2 L nasal cannula baseline Hypoxia appears to be secondary to robust immune response to COVID-19 vaccination Increased hypoxia, fever, leukocytosis, elevated troponin, radiographic evidence of congestive heart failure Will repeat troponin level in the morning, daily chemistry and blood count, will treat congestive heart failure as below � � CHF (congestive heart failure) (HCC) Assessment & Plan Transesophageal echocardiogram from October 2020 noted preserved left ejection fraction, and had no evidence for diastolic dysfunction Radiographic evidence of congestive heart failure, normal BNP, elevated troponin with an increase of 18 at the 2 hour mark, will recheck in the morning As this is her 2nd hospitalization since that echo with hypoxia and concern for CHF, will obtain repeat echocardiogram Received 80 mg IV Lasix in the emergency department, will continue 40 mg IV Lasix 2 times a day Daily weights, 2 L fluid restriction Patient was admitted with acute on chronic hypoxic respiratory failure. I think this is due to acute on chronic diastolic congestive heart failure that was brought on after she was sleeping most of the day without her BiPAP. She says she got her COVID-19 booster shot and felt so tired she slept all day. She did not think she needed her BiPAP during the day even if she was sleeping. She has not had a recent sleep study. Patient is diuresing and will likely be able to discharge tomorrow.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/22/2021,02/23/2021,1.0,PVT,"acetaminophen, apixaban, aspirin, calcium carbonate, citalopram, dronedarone, ezetimibe, Duo-neb, metoprolol succinate XL, mometasone-formoterol, ondansetron, zolpidem,",,"dyslipidemia, OSA, hypertension, COPD, severe, Acute on chronic respiratory failure, persistent atrial fibrillation, Congestive heart failure, morbid obesity, GERD, lung nodules, chronic respiratory failure with hypoxia and hypercapnia",,nkda,"['Acute respiratory failure', 'Cardiac failure congestive', 'Chronic respiratory failure', 'Fatigue', 'Hypersomnia', 'Leukocytosis', 'Malaise', 'Oxygen saturation decreased', 'Oxygen therapy', 'Pain', 'Pyrexia', 'Respiratory failure', 'Robust take following exposure to vaccinia virus', 'Troponin increased', 'X-ray abnormal']",2,MODERNA,IM 1056883,FL,55.0,F,"severe headaches, diffuculty swallowing, pressure in throat, pain in chest, back, neck, arms treatment include visit to ED and hospitalized for 2 days. multiple tests, symptoms ongoing",Not Reported,,Not Reported,Yes,2.0,Yes,N,01/21/2021,01/25/2021,4.0,PVT,"armour thyroid, vesicare, estradiol patch, align probiotic.",none,hashmotos's thyroid disease,,"sulfa, demerol","['Back pain', 'Blood test', 'Chest X-ray', 'Chest pain', 'Computerised tomogram abdomen', 'Computerised tomogram head', 'Computerised tomogram thorax', 'Dysphagia', 'Electrocardiogram', 'Gastric emptying study', 'Headache', 'Hepatobiliary scan', 'Impaired gastric emptying', 'Neck pain', 'Oesophagogastroduodenoscopy', 'Oropharyngeal discomfort', 'Pain in extremity', 'Ultrasound biliary tract']",2,MODERNA,IM 1056948,TN,61.0,F,"Received notification from county director that patient is currently hospitalized beginning two days after Moderna vaccination, spoke to patient today 2/26/2021. Patient received vaccine Monday morning 2/22/2021 around 9:07am, by 9pm Monday evening patient reports weakness, fatigue, sore arm, fever, chills, and no appetite. Patient states symptoms persisted all day Tuesday 2/23/2021. On Wednesday 2/24/2021 at 11:30am patient was eating a peanut butter sandwich and felt something inside mouth. Upon looking in mouth patient noticed ""black sores."" Patient then called husband and was taken to ER and was then transferred to Hospital. Patient states she has been diagnosed with ITP idiopathic thrombocytopenic purpura.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/22/2021,02/22/2021,0.0,PUB,"Primpro 1.5mg once daily, lisinopril/HCTZ 12.5mg once daily, OTC Prilosec every other day, OTC B6 200 mg once daily, OTC MagOx400 once daily,",unknown,unknown,,"Patient states took oral Sulfa medication several years ago and layed out in sun, then developed a rash. Unsure if allergic.","['Asthenia', 'Chills', 'Decreased appetite', 'Fatigue', 'Immune thrombocytopenia', 'Pain in extremity', 'Pyrexia', 'Stomatitis']",1,MODERNA,IM 1056972,ME,77.0,F,"5-6 days after receiving first Moderna covid vaccine pt. began not feeling well. On 02/10/2021 she saw a provider in an office for eval of abdominal pain and diarrhea and sent home. On 02/15/2021 she presented to a local ED with continuing symptoms, transferred to Medical Center, She is currently an inpatient there with a diagnosis of multiple blood clots in abdomen and brain and antiphospholipid syndrome.",Not Reported,,Yes,Yes,,Yes,N,01/29/2021,02/04/2021,6.0,OTH,Acetaminophen,,Depression Hyperlipidemia Anxiety disorder Elevated BP without diagnosis of hypertension Alcohol abuse Osteopenia Tubular adenoma of colon Serrated adenoma of colon Cyst of left breast,,Ampicillin-nausea,"['Abdominal pain', 'Acute myocardial infarction', 'Antiphospholipid syndrome', 'Atrial fibrillation', 'Biliary dilatation', 'Cerebrovascular accident', 'Diarrhoea', 'Dysphagia', 'Electrocardiogram QT prolonged', 'Encephalopathy', 'Endoscopy', 'Gastrointestinal oedema', 'Hepatic cirrhosis', 'Imaging procedure', 'Intestinal angioedema', 'Intestinal mass', 'Intracranial mass', 'Laboratory test', 'Leukocytosis', 'Malaise', 'Oesophageal varices haemorrhage', 'Peritonitis bacterial', 'Supraventricular tachycardia', 'Thrombosis']",1,MODERNA,IM 1057000,MD,33.0,F,Abdominal pain 7 days post vaccine. Diagnosed with appendicitis 9 days post vaccine.,Not Reported,,Yes,Yes,2.0,Not Reported,N,02/05/2021,02/12/2021,7.0,PVT,"Multivitamin, Melatonin, Magnesium, Synthroid, Focalin, Famotidine, Celexa",none,"GERD, Hypothyroid, Anxiety, ADHD",,Zoloft,"['Abdominal pain', 'Appendicitis', 'Computerised tomogram abnormal', 'Culture wound', 'Full blood count', 'Metabolic function test']",2,PFIZER\BIONTECH,IM 1057057,FL,86.0,F,"Petechia and bruising appeared approximately 2 days after receiving the Covid-19 Moderna vaccine. Patient was hospitalized for excessive petechia and bruising in bilateral lower extremities with platelet count of 2,000.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/20/2021,02/22/2021,2.0,PUB,"Alopurinol, Amlodipine, Hydralazine, Levothyroxine, Lisinopril, Omeprazole, OTC multivitamin, Vitamin B-12, and Vitamin D",None,"Hypothyroidism, Stage 3 Kidney Disease, and Hypertension",,"Shrimp, Molds and Mildrew, Hives with Zocar/Zetia/Liptor","['Activated partial thromboplastin time', 'Blood grouping', 'Contusion', 'Crossmatch', 'Full blood count', 'Laboratory test', 'Metabolic function test', 'Petechiae', 'Platelet count decreased', 'Prothrombin level', 'Prothrombin time']",1,MODERNA,IM 1057068,FL,76.0,F,"DIPLOPIA, CONTINUING TO TODAY HYPERTENSION, IMPROVING ON ADDITION OF AMLODIPINE",Not Reported,,Not Reported,Not Reported,,Yes,N,02/12/2021,02/12/2021,0.0,PUB,AMLODIPINE 5 MG 1 QD CALCITRIOL .5 MG 1 QOD ALLOPURINOL 100 1 QD B12 1 MG PO QD + B12 1 MG SC Q MONTH SODIUM BICARB 650 MG 3 QD STOPPED 2/12/2021,NONE,CHRONIC RENAL FAILURE HX HEPATITIS C HX COLON CANCER WITH RESECTION DIFFICULTY ABSORBING FOOD B12 DEFICIENCY,,"SULPHA >NAUSEA, DIZZY INTERFERON","['Diplopia', 'Hypertension', 'Magnetic resonance imaging normal']",2,PFIZER\BIONTECH,IM 1057071,IA,69.0,F,"On the morning of 2/11/2021, I woke up with SUDDEN HEARING LOSS IN MY RIGHT EAR, was dizzy, had balance issues, and was nauseous. I went to the ER. I had a CT in the ER which also was negative for stroke. My hearing loss has NOT returned, and I still have some balance issues as well for which I am receiving PT.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/06/2021,02/11/2021,5.0,PVT,Irbesartan-HCT 150-12.5 mg (two a day) Multi-vitamin Low dose aspirin Probiotic Calcium Citrate (630 mg) w/D-3 (500 mg ) Vitamin D-3 (2000 IU) Tums (1 tablet daily),"Prior to 2/11/2021, I had seen my GP regarding mild vertigo with ringing in the right ear. I was told I would benefit from hearing aids. My GP ordered an MRI -- which came back normal. HOWEVER, on the morning of 2/11/2021, I woke up with SUDDEN HEARING LOSS IN MY RIGHT EAR, was dizzy, had balance issues, and was nauseous. My hearing loss has NOT returned, and I still have some balance issues as well. I had a CT in the ER which also was negative for stroke.",High blood pressure that is controlled with medication.,,Amoxicillin,"['Balance disorder', 'Computerised tomogram normal', 'Dizziness', 'Magnetic resonance imaging normal', 'Nausea', 'Sudden hearing loss', 'Tinnitus', 'Vertigo']",1,PFIZER\BIONTECH,IM 1057082,KY,86.0,M,"Pt admitted to Hospital on 2/8/21 with 2-3 days of SOA and cough. His wife was diagnosed with COVID-19 at approximately the same time when the patient received 1st COVID-19 vaccine. Pt had not felt well since receiving the vaccine and had some changes in taste or smell. He became acutely worse 2-3 days p/t admission with DOE, productive cough, H/A, N/V, profound weakness and bilateral infiltrates on CXR. He was hypoxic on room air. During hospitalization, has gone back and forth from BiPAP to HFNC. Unable to prone. Pt and wife discussed goals of care and decided on comfort measure approach. Pt expired on 2/19/21.",Yes,02/19/2021,Not Reported,Yes,12.0,Not Reported,N,01/30/2021,02/08/2021,9.0,PVT,"Meds prior to admission: Amiodarone, ASA, Lipitor, Cymbalta, Lasix, Norco, Imdur, Lisinopril, Lopressor, Zofran, Potassium chloride, Xarelto",unknown,"Arthritis, Afib, chronic anticoagulation, chronic back pain, coronary arteriosclerosis, DM, GERD, HLD, HTN, kidney stone, PVD, stroke",,Pneumococcal vaccine - rash,"['Angiogram pulmonary abnormal', 'Asthenia', 'Bilevel positive airway pressure', 'Blood culture negative', 'Blood gases', 'COVID-19', 'Chest X-ray abnormal', 'Computerised tomogram thorax abnormal', 'Condition aggravated', 'Cough', 'Death', 'Dyspnoea', 'Full blood count', 'Headache', 'Hypoxia', 'Inflammatory marker test', 'Joint swelling', 'Legionella test', 'Lung infiltration', 'Lung opacity', 'Malaise', 'Nausea', 'Oxygen therapy', 'Parosmia', 'Productive cough', 'SARS-CoV-2 test positive', 'Streptococcus test negative', 'Taste disorder', 'Vomiting']",1,PFIZER\BIONTECH,IM 1057086,SC,70.0,M,Rhabdomyolysis,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/24/2021,02/25/2021,1.0,UNK,"albuterol, glimepiride, insulin, levothyroxine, metFORMIN, naltrexone-bupropion, Qvar, rosuvastatin, valsartan-hydrochlorothiazide, atorvastatin, fluticasone, furosemide, LANTUS, pioglitazone",none,"hypertension, diabetes, Asthma ,Hypercholesterolemia, hypothyroid",,none,"['Blood creatine phosphokinase increased', 'Rhabdomyolysis']",1,PFIZER\BIONTECH,IM 1057255,NC,72.0,F,"Developed respiratory distress, hypertensive emergency, and acute congestive heart failure with bilateral edema of lower legs",Not Reported,,Not Reported,Yes,10.0,Not Reported,,02/03/2021,02/06/2021,3.0,PVT,"Aspirin, lidocaine 4% topical cream, Caltrate, Fosamax, cyanocobalamin, gabapentin, carvedilol, amlodipine, atorvastatin, Lasix",,,,,"['Cardiac failure congestive', 'Hypertensive emergency', 'Oedema peripheral', 'Respiratory distress']",1,MODERNA,IM 1057266,KY,97.0,M,"Bell's Palsy diagnosis. Following 2nd administration of Pfizer COVID vaccine, 97 year old male found on the floor by housekeeping. Sent to ER due to cuts and bruises. MRI ruled out Stroke. Patient presented with a droopy eye & mouth on one side of face. Complained of ear pain on the same side. Patient also tested positive for COVID without any presenting symptoms via PCR test. Patient's will to live has decreased.",Not Reported,,Not Reported,Yes,8.0,Yes,N,02/04/2021,02/18/2021,14.0,SEN,Unknown,None,Neck fracture,,Unknown,"['Asymptomatic COVID-19', 'COVID-19', 'Contusion', 'Ear pain', 'Facial paralysis', 'Fall', 'Magnetic resonance imaging', 'Quality of life decreased', 'SARS-CoV-2 test positive', 'Skin abrasion', 'Skin laceration']",2,PFIZER\BIONTECH,UN 1057280,,77.0,F,Developed shortness of breath. To ER and then hospitalized. Oxygen therapy and lasix given. Possible excerbation of HF. Hospitalized 2 days at Hospital . Discharged home with PCP follow up.,Not Reported,,Not Reported,Yes,,Not Reported,,02/20/2021,02/20/2021,0.0,UNK,,,,,,['Dyspnoea'],1,MODERNA,IM 1057281,MD,77.0,F,patient's husband reported her death that happened after first COVID-19 vaccine,Yes,02/19/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/19/2021,14.0,OTH,,"per husband, stage 4 pancreatic cancer",,,,['Death'],1,MODERNA,IM 1057348,TX,88.0,F,"Extreme Fatigue, slurring speech, unable to stand, eat. Death on 2/5/21",Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/28/2021,2.0,PVT,"lasik, blood pressure",congestive heart failure,congestive heart failure,,none,"['Death', 'Dysarthria', 'Dysstasia', 'Fatigue', 'Feeding disorder']",1,PFIZER\BIONTECH,IM 1057363,,89.0,M,Patient with severe dementia in Hospice Care,Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,,02/13/2021,02/13/2021,0.0,UNK,,,,,,"['Death', 'Dementia']",UNK,MODERNA, 1057377,WI,76.0,F,"On the evening of the first vaccination, my sister experienced chills and fever. The next morning she experienced a kind of paralysis, could not sit up or stand up, was falling out of bed and out of her chair, had to be carried to the bathroom, although she usually can walk by herself. This lasted about a day. I took her to the ER where they excluded other possible causes of her condition and simiply attributed it to the vaccine. No treatment was prescribed.",Not Reported,,Not Reported,Not Reported,,Yes,Y,02/05/2021,02/05/2021,0.0,PHM,Several anti-depressants and anti-psychotic medications,Covid infection 70 days before vaccination,"Cerebral palsy with enlarged ventricles of the brain; Vaccination resulted in partial paralysis for a little more than a day, suggesting a severe neuroinflammatory response. Will not follow up with the second shot.",,None,"['Blood test', 'Chills', 'Dysstasia', 'Fall', 'Mobility decreased', 'Paralysis', 'Pyrexia', 'Red blood cells urine positive', 'Respiratory viral panel', 'SARS-CoV-2 test', 'Urine analysis abnormal', 'Vaccination complication', 'White blood cell count normal']",UNK,MODERNA,IM 1057394,IN,65.0,M,"Acute renal failure, needed dialysis.",Not Reported,,Yes,Yes,8.0,Not Reported,U,12/22/2020,02/10/2021,50.0,PVT,amlodipine 5 mg metoprolol 100 mg prilosec 20 mg losartan 25 mg,None,GERD Coronary heart disease Hypertension,,None.,"['Acute kidney injury', 'Blood creatinine', 'Dialysis']",1,PFIZER\BIONTECH,IM 1057547,TX,,M,"86 year old manager received the two doses of the Moderna vaccine and died; A spontaneous report was received from a consumer, concerning an 86-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed away. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient received their doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection. On an unspecified date, it was reported that the patient passed away after receiving both doses. The cause of death was unknown. It was unknown if an autopsy was performed. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the events is not applicable. The outcome of event ""86 year old manager received the two doses of the Moderna vaccine and died"" was fatal.; Reporter's Comments: Very limited information regarding this event has been provided at this time. No autopsy report provided. Further information has been requested.; Reported Cause(s) of Death: 86 year old manager received the two doses of the Moderna vaccine and died",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Death'],2,MODERNA, 1057548,,55.0,M,"bilateral pulmonary embolism; multiple areas of infarct; back pain; ateltheisis; chest pain; left leg pain; deep vein thrombosis; pulmonary effusions; fever; Chills; myalgia; A spontaneous report was received from a physician who was also a 55-year-old, previously healthy male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever/pyrexia, chills, myalgia, chest and back pains, bilateral pulmonary embolism/pulmonary embolism, multiple areas of infarct/pulmonary infarct, ateltheisis/atelectasis, left leg pain, and deep vein thrombosis. The patient's medical history included daily exercise and no personal or family history of clotting issues and no trauma. Products known to have been used by the patient were not provided. On 02 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 039k20-2a) intramuscularly for prophylaxis of COVID-19 infection. On 30 Jan 2021, approximately 28 days after the first dose, and prior to the onset of symptoms, the patient received the second of two planned doses of mRNA-1273 (Lot number: 012m20a) intramuscularly for the prophylaxis of COVID-19 infection. On 30 Jan 2021, the patient reports that for the first 18 hours, he experienced fever, chills and myalgia. On 01 Feb 2021, the patient reports that he thought the myalgia was continuing, as he had pain in his chest and back. The chest pains gradually worsened. On 05 Feb 20221, the patient went to the emergency room and was admitted. He was diagnosed with a pulmonary embolism. He was started on enoxaparin sodium but switched to apixaban. A computerized tomography study of the lungs showed that he had bilateral pulmonary embolism, multiple areas of infarct and atelectasis. His dimer was 4800. COVID-19 test was negative. An echocardiograph was performed, no results were reported. An ultrasound of the legs was performed and ruled out deep vein thrombosis. Date of discharge was not specified. On an unknown date two days after discharge, the patient experienced left leg pain and returned to the emergency department. Patient was diagnosed with deep vein thrombosis that ran the entire length of the femoral artery. Patient was switched back to enoxaparin sodium and taken off the apixaban. A repeat computerized tomography study was done to see if the pulmonary embolism was progressing and it was not, however, it showed pulmonary effusions. All current lab work was reported as normal, except for an increased prothrombin time. COVID-19 test was negative. Patient continues to be followed by a pulmonologist and hematologist. Consent to contact patient, pulmonologist and hematologist was obtained. Action taken with mRNA-1273 was not applicable. The outcome of the events, fever/pyrexia, chills, myalgia, chest and back pains, bilateral pulmonary embolism/pulmonary embolism, multiple areas of infarct/pulmonary infarct, ateltheisis/atelectasis, left leg pain, and deep vein thrombosis, was considered not resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.",Not Reported,,Yes,Yes,,Not Reported,Y,01/02/2021,01/30/2021,28.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical history not provided),,,"['Atelectasis', 'Back pain', 'Chest pain', 'Chills', 'Computerised tomogram', 'Deep vein thrombosis', 'Fibrin D dimer', 'Myalgia', 'Pain in extremity', 'Pleural effusion', 'Prothrombin time prolonged', 'Pulmonary embolism', 'Pulmonary infarction', 'Pyrexia', 'SARS-CoV-2 test', 'Ultrasound scan']",1,MODERNA,OT 1057549,,,F,"My first vaccine I received it gluteal; A spontaneous report was received from a consumer regarding themselves, a patient of unreported age and sex regarding receiving the fist dose of Moderna's mRNA-1273 vaccine via the gluteus muscle/inappropriate route of administration. The patient's medical history was not included. Products known to have been used by the patient were not provided. On an unspecified date, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the gluteus for prophylaxis of COVID-19 infection. Patient was given the injection into the gluteus muscle and not the deltoid muscle. Consent to contact was obtained. Treatment information was not provided. Action taken with mRNA-1273 was not reported. The outcome of the events, dose being administered in the gluteus and not the deltoid muscle, was considered resolved.; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious unexpected event of Incorrect route of product administration with mRNA-1273 (Lot # unknown), with no associated adverse events. Reporter stated that the injection was given into the gluteus muscle and not the deltoid muscle. The event occurred the same day as the first dose of mRNA-1273. Very limited information has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Incorrect route of product administration'],1,MODERNA,OT 1057550,TN,79.0,F,"has sporadic a-fib (at baseline); She stated she was in real bad stroke territory; she felt like she was going to faint; Her blood pressure was 220/97; tingling in her hands and feet; felt like brain sizzling like it was frying/going to faint; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN9581, first dose) solution for injection intramuscular in the left arm on 06Feb2021 at 09:30 (at the age of 79-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing sporadic A fib (atrial fibrillation) for 6 years know about; allergy to polyethylene glycol in 1985 (she had difficulty taking birth, control pills and they found out it was the coating PEG in); cerebrovascular accident prophylaxis; in 1985 She had difficulty taking birth control pills and they found out it was the coating PEG in it. She had an allergy to this where she broke out in bumps on her fingers and mouth and had itchy eyes, a full blown allergy; and when she was 45 going through menopause. Concomitant medication included apixaban (ELIQUIS) for A fib and cerebrovascular accident prophylaxis. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Feb2021, the patient had sporadic a-fib (at baseline) then put in a medical van requiring emergency room visit. The patient stated, She stated she was in real bad stroke territory, felt like she was going to faint (6 minutes after vaccination), blood pressure was 220/97, tingling in her hands (6 minutes after vaccination) and feet and felt like brain sizzling like it was frying/going to faint (6 minutes after vaccination) on 06Feb2021. Lab tests included blood pressure on an unknown date high 150s and never lower than 187, then on 06Feb2021 was 220/97, on 09Feb2021 was systolic blood pressure 180, then on 10Feb2021 had gone down. The outcome of the events atrial fibrillation and feeling unwell was recovered on 06Feb2021, after 3 hours. The outcome of the events stroke, faint and tingling of extremity was unknown. The outcome of the event blood pressure was 220/97 was recovered on 10Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/06/2021,0.0,UNK,ELIQUIS,AFib (6 years know about),"Medical History/Concurrent Conditions: Allergy to chemicals (In 1985 She had difficulty taking birth, control pills and they found out it was the coating PEG in); Blistery rash (In 1985 She had difficulty taking birth control pills and they found out it was the coating PEG in it. She had an allergy to this where she broke out in bumps on her fingers and mouth and had itchy eyes, a full blown allergy); Cerebrovascular accident prophylaxis; Eye itching (In 1985 She had difficulty taking birth control pills and they found out it was the coating PEG in it. She had an allergy to this where she broke out in bumps on her fingers and mouth and had itchy eyes, a full blown allergy); Menopause (when she was 45 going through menopause)",,,"['Atrial fibrillation', 'Blood pressure measurement', 'Cerebrovascular accident', 'Hypertensive crisis', 'Malaise', 'Paraesthesia', 'Syncope']",1,PFIZER\BIONTECH,OT 1057551,FL,,F,"Arm pain; arm with shot is swollen getting red; arm with shot is swollen getting red; Injection site is swelling and the pain is worse; Injection site is swelling and the pain is worse/Injection site pain; Arm was stiff; Crohn's disease went crazy/worse Crohn's flare; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age (reported as '75', units unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration in the arm on 06Feb2021 at a single dose for COVID-19 immunization. Medical history included ongoing Crohn's disease. The patient's concomitant medications were not reported. The patient previous had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), on an unspecified date for COVID-19 immunization. The patient had her Pfizer second shot received on Saturday (06Feb2021) and after the shot she had arm pain (same as after the first shot) and Crohn's disease went crazy and she keep wanted to run to bathroom. Arm hurt a few days then it went away. Injection site pain started again last night and her arm with shot is swollen and getting red, she put ice on it and it's hurting. Today, it was slightly more red and swollen. The injection site is swelling, and the pain is worse than the 1st dose. The patient has Crohn's disease and was having a whole problem with that at the moment. She had gotten the second Covid shot on Saturday and on Sunday (07Feb2021), had the worse Crohn's flare she's actually ever had in 35 years. The day after the shot (07Feb2021), her arm was stiff and that is what happened after the first shot also. It cleared up on Monday and Tuesday. Last evening, Wednesday, her upper arm on the injections site arm started to hurt and get swollen. Since it was last night, she had no one to call and called the pharmacy and was told to put ice on it and she did. It's getting worse and worse and angry like and getting more swollen. The patient wanted to know what she should do in this situation. The outcome of the event ""arm was stiff"" was recovered on Feb2021 while the other events were unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/07/2021,1.0,UNK,,Crohn's disease,,,,"[""Crohn's disease"", 'Erythema', 'Musculoskeletal stiffness', 'Pain in extremity', 'Peripheral swelling', 'Vaccination site pain', 'Vaccination site swelling']",2,PFIZER\BIONTECH, 1057552,,65.0,F,"lost complete hearing in her left ear/hearing was almost completely gone based on the audiology test; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EN5318 and expiry date unknown, via unspecified route of administration at the left arm on 02Feb2021 15:30 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no covid prior vaccination. On 02Feb2021 16:00 (30 minutes after receiving the vaccination), The patient lost complete hearing in her left ear. The patient informed that it came on very suddenly and did not improve by the next morning. The patient contacted her doctor at the clinic and was scheduled for a hearing test on Thursday at 9:30 and an appointment with an ENT afterwards. The hearing was almost completely gone based on the audiology test (Feb2021). The patient began very high levels of steroids for a 14-day program and her hearing has started to return. The patient also had an MRI done on Monday (Feb2021) showing no abnormalities. The patient was not covid tested post vaccination. The patient informed that this seemed to be a very real coincidence that the vaccine triggered this response to her hearing. The outcome of the event was recovering. The event was considered serious (disability).",Not Reported,,Not Reported,Not Reported,,Yes,N,02/02/2021,02/02/2021,0.0,UNK,,,,,,"['Acoustic stimulation tests', 'Deafness', 'Magnetic resonance imaging']",1,PFIZER\BIONTECH, 1057553,IL,24.0,F,"hallucination; severe confusion; dizziness/light headedness; disorientation; fatigue; tachycardia; anxiety; full body weakness; full body muscle aches; chills; headache; This is a spontaneous report from a contactable healthcare professional (patient). A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3247), intramuscular in left arm on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included generalised anxiety and allergies: Sulfa sensitive. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported. On 22Jan2021, 45-60 minutes after vaccination, patient experienced hallucination, severe confusion, dizziness/light headedness, disorientation, fatigue, tachycardia, anxiety, full body weakness, then on 22Jan2021, 8 hours after, patient had full body muscle aches, headache, chills, fatigue, confusion, hallucination, anxiety, tachycardia, 16 hours after, experienced confusion, full body muscle aches, headache, chills, fatigue, confusion, hallucination, tachycardia, anxiety, then 48 hours after, had confusion, full body muscle aches (TYLENOL helped), headache, fatigue, confusion, hallucination, tachycardia, anxiety, then 1 week after vaccination, patient was experiencing confusion, anxiety, and hallucinations throughout the entire week. Patient was unsure if she ever had a fever, as she did not check her temperature. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID saliva test: negative on 27Jan2021 and negative on 10Feb2021. Therapeutic measures were taken as a result of full body muscle aches. No treatment was received for the other adverse events. The outcome of the events was recovered with sequelae.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported event hallucination cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,SCH,,,Medical History/Concurrent Conditions: Generalized anxiety disorder (Generalized Anxiety); Sulfonamide allergy (allergies: Sulfa sensitive),,,"['Anxiety', 'Asthenia', 'Chills', 'Confusional state', 'Disorientation', 'Dizziness', 'Fatigue', 'Hallucination', 'Headache', 'Myalgia', 'SARS-CoV-2 test', 'Tachycardia']",1,PFIZER\BIONTECH,OT 1057554,OH,64.0,F,"cellulitus around left eye which spread down left cheek, across chin and started up the right cheek; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on the left arm, on 16Jan2021 at 12:00, at a single dose for Covid-19 immunization. The patient has no medical history and no known allergies. Concomitant medication included amoxicillin. On 24Jan2021, the patient experienced cellulitis around left eye which spread down left cheek, across chin and started up the right cheek. The adverse event resulted in doctor or other healthcare professional office/clinic visit, hospitalization. The patient was hospitalized for 6 days. The patient has no Covid prior vaccination and was Covid tested post vaccination. The patient had a nasal swab on 28Jan2021 and result was negative. The patient was recovering from the event. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,01/16/2021,01/24/2021,8.0,SEN,AMOXICILLIN,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Cellulitis', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1057555,WA,72.0,F,"injection site area was red; injection site was swollen; injection site area was painful; injection site area was warm to touch; This is a spontaneous report from a contactable nurse and consumer. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL9265, intramuscular on 29Jan2021 11:30 at a single dose in the left arm for COVID-19 immunization. Medical history included asthma from 2010, hypothyroidism diagnosed in 2000, obesity from 1995, hypertension from 2000. She has allergies to medications and environmental, allergic to Gadolinium dye. She had an anaphylactic reaction in a hospital, mostly due to food and environmental. No additional vaccines administered on the same date and no prior vaccinations within 4 weeks. Concomitant medication included benralizumab (FASENRA PEN) for asthma (taking for a couple of years). The patient previously took hydrochlorothiazide and experienced allergy. The patient received the first covid vaccine dose on 29Jan2021 and was fine until this morning (11Feb2021 at 9:00) when she woke up and the left arm injection site area was red, swollen, painful and warm to touch. Her height was under 5 feet. The outcome of the events was not recovered. The events Left arm injection site area is red, swollen, painful and warm to touch were assessed as serious-medically significant. Causality of the events to the suspect drug was related.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported ""the left arm injection site area was red, swollen, painful and warm to touch"" and the administration of the COVID-19vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/11/2021,13.0,OTH,FASENRA PEN,,Medical History/Concurrent Conditions: Anaphylactic reaction; Asthma; Contrast media allergy; Drug allergy; Environmental allergy; Hypertension; Hypothyroidism; Obesity,,,"['Body height', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling', 'Vaccination site warmth']",1,PFIZER\BIONTECH,OT 1057556,CA,70.0,F,"slight soreness on head; Knees extremely sore; passed out; fuzzy feeling; This is a spontaneous report from a contactable consumer(patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809) on 10Feb2021 at 16:30 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included type 2 diabetes mellitus, hypertension and allergy to Victoza. Concomitant medications included metformin, dulaglutide (TRULICITY), atorvastatin and fluoxetine. On 10Feb2021 at 21:00 about the patient five hours after vaccine in kitchen washing dishes, passed out. No symptoms or light headedness leading up to this event. Patient woke up on floor hit head minor and knees. On 11Feb2021 the patient complained slight soreness on head, fuzzy feeling. Knees extremely sore, small cut on ankle. Her doctor adviced to report this due to the time event happened in relation to vaccine (as reported). No treatment reported for events. At the time of the reporting the patient was recovering from the events. .",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/10/2021,0.0,UNK,METFORMIN; TRULICITY; ATORVASTATIN; FLUOXETINE,,"Medical History/Concurrent Conditions: Hypertension; Type 2 diabetes mellitus (Other medical history: Type 2 Diabeted, High blood pressure)",,,"['Arthralgia', 'Feeling abnormal', 'Headache', 'Loss of consciousness']",1,PFIZER\BIONTECH, 1057557,PA,31.0,F,"Miscarriage 8 days after receiving 2nd vaccine at 6 weeks pregnant; receiving 2nd vaccine at 6 weeks pregnant; receiving 2nd vaccine at 6 weeks pregnant; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration in the left arm on 28Jan2021 08:30 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 07Jan2021 at 09:00 AM for COVID-19 immunization. Patient was pregnant. Patient has no other vaccines in four weeks and no other medications in two weeks. Patient has no COVID prior vaccination and no known allergies. On 05Feb2021 at 06:00 PM, patient experienced miscarriage 8 days after receiving 2nd vaccine at 6 weeks pregnant. No treatment received for the event miscarriage. The event resulted in doctor's office/clinic visit. The patient was not tested for COVID post vaccination. The outcome of the event miscarriage was recovering. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the compatible temporal association, a possible contributory role of the vaccination with BNT162B2 in triggering the onset of miscarriage in this patient at 6 weeks pregnant cannot be excluded. Additional information regarding relevant medical history, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,PVT,,,,,,"['Abortion spontaneous', 'Off label use', 'Product use issue']",2,PFIZER\BIONTECH, 1057558,OH,26.0,F,"trouble breathing; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that she is a 26-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization at a hospital. Patient has a history of breathing problems (unspecified). On 06Feb2021, patient went into hospital due to trouble breathing. Treatment included antibiotics (unspecified) and prednisone 125 mg intravenous (IV) in the hospital and then took oral prednisone 40 mg for 4 days after being discharged on 10Feb2021. Patient further stated that she was in emergency for 4 days, and was given 125 mgs of prednisone, and that she was there in the emergency, but didn't want to stay, and was sent with prednisone and antibiotics, she was off the antibiotics not the prednisone after discharge. As of 11Feb2021, patient was off of prednisone. The patient had an unspecified blood work in the hospital and was reported to be everything was fine in Feb2021 had blood work. Outcome of the event was unknown. The patient does not feel like her breathing problems were related to the COVID-19 vaccine since she has a history of breathing problems that were aggravated in cold weather. The patient was to receive the second dose on 18Feb2021 and has inquired if she can take the shot given her problem. Information on batch/lot number has been requested.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,01/28/2021,02/06/2021,9.0,PVT,,,Medical History/Concurrent Conditions: Respiratory disorder,,,"['Blood test', 'Dyspnoea']",1,PFIZER\BIONTECH, 1057559,CA,65.0,F,"anaphylactic reaction; having issues breathing/didn't have normal respiratory support; swallowing, weakness, unable to take anything by mouth/had lost ability to swallow; swallowing, weakness, unable to take anything by mouth; affected my lungs, gut, muscles, everything.; still having lung issues; This is a spontaneous report from a contactable consumer(patient). A 65-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number RM9809), via an unspecified route of administration on 03Feb2021 at the 65 years old at single dose for COVID-19 immunization. The medical history included Muscular dystrophy. The concomitant medications included unspecified multiple medications. The patient received the first dose on 03Feb2021. Immediately after the vaccine on 03Feb2021 she had an anaphylactic reaction, received an Epipen, went to the ER was given steroids and sent home. Next day, still having symptoms, received second Epipen administration, went to Urgent Care, was admitted to hospital 04Feb2021. The patient stated she had a history of muscular dystrophy. She stated she was having issues breathing, swallowing, weakness, unable to take anything by mouth, didn't have normal respiratory support in Feb2021. It had affected her lungs, gut, muscles, everything. She may leave here on hospice. She wanted to know if there were others who had reported side effects such as hers. She had anaphylactic reaction to the mineral. She was still in the hospital. She had lost ability to swallow and she was still having lung issues in Feb2021. She was a disabled rehab healthcare worker. She did not have an address right now in the hospital but if sent her something later once she get out she will be able to do that but she did not have it now. She takes multiple medications. Right now she cannot take medications she need orally. She had gone to hospital getting meds via primarily IV. She had acute anaphylactic reaction immediately after the vaccine and went by ambulance to hospital and was given steroids, care basically and sent home and she still had issues the next day and it kept going from home to urgent care to admission at the hospital. She had done lot of lab tests in Feb2021. She was very concerned that this was not going to be a temporary issue. She had form of muscular dystrophy and now what was happening was the week before she got the vaccine totally independent in her home, feeling ok, medications okay and now she was at IV medications not being able to swallow. She talked to someone yesterday and they told she should be calling and reporting what happened and that was why she had been on the phone all day. She just want make sure she did not feel like the healthcare was reaching out to their own vaccination department and she want to make absolutely sure that not only does Pfizer know that have a horrid reaction but she want the healthcare firm that she had a horrid reaction and she want the CDC to know that she had a horrid reaction because right now she would tell all her friends with the severe form of muscle dystrophy she had not going to be vaccinated even though the researchers were telling her to get vaccinated. It was going to take a while to stop the efficacy again and having to be on the phone everyday when she was barely breathing. The patient underwent lab tests and procedures, which included Lab test unknown result in Feb2021. The outcome of the events was unknown.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/03/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Muscular dystrophy,,,"['Anaphylactic reaction', 'Asthenia', 'Dysphagia', 'Dyspnoea', 'Laboratory test', 'Lung disorder', 'Malaise']",1,PFIZER\BIONTECH, 1057560,,,F,"she is legally blind; felt a little tired; a little anxious; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself, a female patient of an unspecified age (reported as 63, no units) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she had the first dose of the vaccine and felt a little tired and a little anxious one day but she felt it was because she was nervous about getting it. The patient stated she was legally blind and it was hard for her to read some things. The patient asked how long side effects will last, if she would get any, and if how long do the symptoms last after the second dose. She also asked if one did not have any side effects after the first vaccine, could they still get side effects after the second. The patient asked if people can take their medications as usual after receiving the vaccine, and if she could take Tylenol after the vaccine if she get symptoms. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Anxiety', 'Blindness', 'Fatigue']",1,PFIZER\BIONTECH, 1057561,NH,56.0,F,"mental fog; Headache; fatigue; pain in armpit; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location: arm left) on 05Feb2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and patient's concomitant medications were not reported. Patient is not pregnant. Patient has no covid prior vaccination. It was unknown if patient got tested post vaccination. It was unknown if patient had vaccine in four weeks and unknown if other medications in two weeks. The patient experienced mental fog (medically significant); headache, fatigue, and pain in armpit. All the events occurred on 06Feb2021. It was reported that the events were continuing after 6 days. No treatment was provided for the events. Facility type vaccine was nursing home. Outcome of the events was not recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,SEN,,,,,,"['Axillary pain', 'Fatigue', 'Headache', 'Mental impairment']",UNK,PFIZER\BIONTECH, 1057562,NC,69.0,F,"disoriented/disorientation; low oxygen saturation; acute CHF; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El3247, expiry date: unknown), via an unspecified route of administration on 23Jan2021 15:15 (at the age 69 years old) at a single dose, in the right arm for covid-19 immunisation. Medical history included fibromyalgia and polymyalgia. The patient's concomitant medications included other medications both prescribed and over the counter. The patient had no other vaccine in four weeks. The patient was not diagnosed with covid-19 prior to vaccination. On 24Jan2021 at 0900, the patient experienced disorientation that was present then went away and the patient seemed to be okay; low oxygen saturation and acute congestive heart failure (CHF). On Monday, she was disoriented again and went to emergency room (ER). All the events resulted in emergency room visit and hospitalization for seven days. The patient underwent lab test and procedures which included nasal swab covid test on 25Jan2021 which showed negative. Outcome of all the events was recovered on unspecified date.",Not Reported,,Not Reported,Yes,7.0,Not Reported,Y,01/23/2021,01/24/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Fibromyalgia; Polymyalgia,,,"['Cardiac failure congestive', 'Disorientation', 'Oxygen saturation', 'Oxygen saturation decreased', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1057563,NJ,22.0,F,"fainted; Nausea; Headache; Slight fever; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 06Feb2021 17:00 at a single dose for COVID-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. The patient is not pregnant. On 07Feb2021 09:15, the patient fainted 16 hours after getting the shot. The patient also experienced nausea, headache and slight fever. The events were assessed as serious (medically significant). No treatment was received for the events. The outcome of the events was recovered on an unspecified date. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/07/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Asthma,,,"['Headache', 'Nausea', 'Pyrexia', 'Syncope']",1,PFIZER\BIONTECH, 1057564,FL,68.0,F,"sustained high blood pressure; Have 2 aneurysms; Continuous headache; some dizziness; This is a spontaneous report from a contactable 68-year-old female consumer reported for herself. A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL9262), via an unspecified route of administration (right arm) on 26Jan2021, 17:15 at SINGLE DOSE for covid-19 immunisation, at 68 years old. Medical history included allergies: Penicillin from an unspecified date. Patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is taking unspecified concomitant medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EH 9899, at 68 years old), on 05Jan2021, 16:30, right arm for COVID-19 immunization. The patient experienced sustained high blood pressure, have 2 aneurysms, continuous headache, and some dizziness on 26Jan2021. Therapeutic measures were taken as a result of the events which include 3 different blood pressure medications, still not under control; medications and monitoring of pressure. She mentioned she has 2 aneurysms so she needs to keep her pressure normal. Outcome of the events was not recovered. The event was considered non-serious by the reporter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Penicillin allergy (allergies: Penicillin),,,"['Aneurysm', 'Blood pressure measurement', 'Dizziness', 'Headache', 'Hypertension']",2,PFIZER\BIONTECH, 1057565,,,M,"He had an infection, a UTI, Sepsis; He had an infection, a UTI, Sepsis; walking to the car when he started shaking; he felt freezing; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (reporter's husband). A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Report's husband who got his first vaccine at the same time (unknown date reported as two and a half weeks ago) as the reporter, she was walking to the car when the patient started shaking and said he felt freezing on unknown date. Later that night reporter had to call an ambulance. He was rushed to ER (emergency room) and hospitalized for 5 days. The patient had an infection, a UTI, Sepsis. He did not know had a UTI and the doctors believe that between the COVID vaccine and infection the two went crazy and beat up on each other. The patient was in the hospital for five days after his COVID shot. It was a combination of an infection and he didn't know and didn't have any symptoms. The two just clashed. He was very sensitive about it. He was feeling better and clean and clear. He was getting the second one. The outcome of events was recovering. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,,,,UNK,,,,,,"['Feeling cold', 'Sepsis', 'Tremor', 'Urinary tract infection']",1,PFIZER\BIONTECH, 1057566,SC,65.0,M,"pneumonia; Diagnosed with COVID after getting the first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program, via a contactable consumer (reporting for himself). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on his right arm on 21Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Jan2021, the patient was diagnosed with COVID after getting the first dose of the vaccine and experienced pneumonia. The outcome of the event was unknown. Information about batch/lot number requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/27/2021,6.0,UNK,,,,,,"['Pneumonia', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1057567,CO,42.0,F,"felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; difficulty swallowing; hard time thinking and talking normal; hard time thinking and talking normal; This is a spontaneous report from a contactable consumer (patient) A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en9815) on 11Feb2021 at 15:45 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included congenital adrenal hyperplasia and slight lactose intolerance. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), prednisone and naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]). On 11Feb2021 patient experienced dizzy, felt like she was to pass out, brain fog/hard time thinking and talking normal, tightness of chest and throat, difficulty swallowing. Events resulted in visit to emergency room. The latter 2 events continued to get worse so they gave the patient an epinephrine injection (reported as EPI shot). Benadryl IV was also administered. At the time of the reporting the patient was recovering from reported events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,PVT,WELLBUTRIN; PREDNISONE; EYE DROPS [NAPHAZOLINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Congenital adrenal hyperplasia; Lactose intolerance (Allergies: slight lactose intolerance),,,"['Chest discomfort', 'Dizziness', 'Dysphagia', 'Feeling abnormal', 'Mental impairment', 'Speech disorder']",1,PFIZER\BIONTECH, 1057568,OH,73.0,M,"had a sudden severe sugar drop to 38; close to passing out; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: 59267-1000-01), via unknown route of administration on left arm on 05Feb2021, at 17:00 at the age of 73 years old at a single dose for COVID-19 immunization administered at Pharmacy or drug Store. Medical history included hypoglycemia. Concomitant medications included diltiazem, lansoprazole, cimetidine, acarbose and omeprazole (ZOL). Past drug event included allergy to doxycyclene. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient stated, ""I have hypoglycaemia"", ""On 05Feb2021, about 4 hrs after vaccine I had a sudden severe sugar drop to 38. No warning signs like I usually have. Followed normal process of bringing sugar back up with Glucose tablets, boost and protein bar. Was close to passing out and just wanted to make someone aware that this could happen. I did call and talk to the pharmacist about it"". The patient assessed the events as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the events on an unspecified date in Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,PHM,DILTIAZEM; LANSOPRAZOLE; CIMETIDINE; ACARBOSE; ZOL,,Medical History/Concurrent Conditions: Hypoglycemia,,,"['Blood glucose decreased', 'Investigation', 'Presyncope']",UNK,PFIZER\BIONTECH, 1057569,FL,73.0,M,"A-Fib recurred with a vengeance; A-Fib recurred with a vengeance; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9262), via an unspecified route of administration on 10Feb2021 13:00 at single dose (arm left) for Covid-19 immunization. Medical history included atrial fibrillation (AFib) treated well with Diltiazem. The patient had no allergies to medications, food and other products. Concomitant medication included diltiazem for Afib. On 11Feb2021 11:00, 22 hours after vaccine, A-Fib recurred with a vengeance, requiring an emergency room (ER) visit and overnight stay in hospital in order to stabilize. The patient was hospitalized on 11Feb2021 to 12Feb2021. The patient was treated with diltiazem I.V. for 12 hours. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient received diltiazem within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient been tested for COVID-19. Outcome of event was recovered on an unspecified date.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/10/2021,02/11/2021,1.0,UNK,DILTIAZEM,,"Medical History/Concurrent Conditions: Atrial fibrillation (A-Fib, treated well with Diltiazem 30 mg. BID.)",,,"['Atrial fibrillation', 'Disease recurrence']",1,PFIZER\BIONTECH, 1057570,CA,50.0,F,"Salivary gland infection; Sjogren's syndrome (mouth inflammation); Sjogren's syndrome (mouth inflammation); Lymph gland infection; Tooth disorder (rancid); Swelling in upper cheeks and ears; Swelling in upper cheeks and ears; Eyes are burning and a little bit dry; Eyes are burning and a little bit dry; Mouth really hurt to me; Flu; This is a spontaneous report from a contactable consumer reporting for herself. A 50-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# CL3302), via an unspecified route of administration, on 01Feb2021, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from Apr2020 to an unknown date, Sjogren's syndrome from 2015 and ongoing (was under control), fibromyalgia, autoimmune disorder, ongoing hormone level abnormal (taking estrogen), ongoing eye disorder. Concomitant medications included ongoing ciclosporin (RESTASIS) for eye disorder, famotidine (PEPCID), albuterol [salbutamol] (unknown manufacturer), ongoing estradiol (ESTROGEN) for hormone level abnormal. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation and experienced pain, asthma and nasal irritation. The patient experienced salivary gland infection (medically significant) in Feb2021 with outcome of unknown, Sjogren's syndrome (mouth inflammation) (medically significant) in Feb2021 with outcome of unknown, lymph gland infection in Feb2021 with outcome of unknown, tooth disorder (rancid) in Feb2021 with outcome of unknown, swelling in upper cheeks and ears in Feb2021 with outcome of unknown, eyes are burning and a little bit dry in Feb2021 with outcome of unknown, mouth really hurt to me in Feb2021 with outcome of unknown, flu in Feb2021 with outcome of unknown. The patient went to the emergency room for Sjogren's syndrome (mouth inflammation) and tooth disorder (rancid). On unknown date the patient underwent lab tests and procedures which included blood electrolytes: unknown results, full blood count: unknown results, investigation: unknown results, monocyte count: normal. Therapeutic measures were taken as a result of the events and included treatment with Salagen and Tylenol. The reporter stated she believed to have a reaction from the vaccine shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,RESTASIS; PEPCID [FAMOTIDINE]; ALBUTEROL [SALBUTAMOL]; ESTROGEN,Eye disorder; Hormone level abnormal (taking estrogen); Sjogren's syndrome (Was under control),Medical History/Concurrent Conditions: Autoimmune disorder; COVID-19; Fibromyalgia,,,"['Blood electrolytes', 'Condition aggravated', 'Dry eye', 'Ear swelling', 'Eye irritation', 'Full blood count', 'Influenza', 'Investigation', 'Lymph gland infection', 'Monocyte count', 'Oral pain', 'Sialoadenitis', ""Sjogren's syndrome"", 'Swelling face', 'Tooth disorder']",2,PFIZER\BIONTECH, 1057684,SC,86.0,M,"Two nosebleeds; Heart skipped all day long; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EU9231, unknown expiration), via an unspecified route of administration in left arm on 22Jan2021 at a single dose for prevention; apixaban (ELIQUIS), oral from an unspecified date at 2.5 mg twice daily for thromboembolism prophylaxis; and ranolazine (RANEXA), oral from an unspecified date at 500 mg twice daily for an unspecified indication. Medical history included bypass surgery in 2007, stent placement (5 stents), and 3 blocked arteries, diagnosed several years ago, he guesses he is living on half of them. There were no concomitant medications. The patient received his first shot of COVID vaccine on 22Jan2021. The patient then experienced two nosebleeds, they did not ask if he had been on a blood thinner, he takes Eliquis, 2.5mg and Ranexa, so his question is a couple days, his heart skips beats anyway, but on the 13th day, it skipped all day long, so he was concerned about the other shot, he was supposed to get it today, he was concerned because he had bypass surgery, had 5 stents, 3 blocked arteries now that they can't do anything about. He was calling about COVID vaccine. He took it 3 weeks ago today and was supposed to get second shot. Concerned as to whether or not he should take it. He was supposed to get the second shot today (12Feb2021), doesn't know, but was really concerned about whether he should take or not. Nosebleeds were the 13th day after the shot (on 04Feb2021). He has recovered completely from nosebleeds. He stated he only bled for a couple seconds. Heart skipped all day long the 13th day after taking the shot (on 04Feb2021), states it is doing fine at this time, comes and goes, may skip one day, next day maybe 3 times and skip, then 4 times and skip, he guesses he has a crazy heart. The patient recovered from the event two nosebleeds on unspecified date, while unknown outcome for the remaining event. The action taken in response to the events for apixaban and ranolazine was unknown. Additional information was also received by Pfizer from Bristol-Myers Squibb Company (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-016064), license party for Apixaban. This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Two nosebleeds) and EXTRASYSTOLES (Heart skipped all day long) in 86-year-old male patient who received apixaban (Eliquis) tablet for Thromboembolism prophylaxis. CO-SUSPECT PRODUCTS included ranolazine (Ranexa) tablet for an unknown indication and Covid-19 Vaccine injection for Prevention. The patient's past medical history included Bypass surgery in 2007, Stent placement and Arterial occlusion. On an unknown date, the patient started Eliquis (Oral), 2.5 milligram twice a day and Ranexa (Oral), 500 milligram twice a day. On 22-Jan-2021, the patient started Covid-19 Vaccine (unknown route) by injection once to left shoulder. On 04-Feb-2021, an unknown time after starting Eliquis, the patient experienced EPISTAXIS (Two nosebleeds) and EXTRASYSTOLES (Heart skipped all day long). The action taken with Eliquis(Oral) was unknown. At the time of the report, EPISTAXIS resolved and EXTRASYSTOLES outcome was unknown. For Eliquis(Oral), the reporter did not provide any causality assessments. Nosebleeds were the 13th day after the shot. He took shot on 22Jan2021. Has recovered completely from nosebleeds. States he only bled for a couple seconds. Heart skipped all day long the 13th day after taking the shot, states it is doing fine at this time, comes and goes, may skip one day, next day maybe 3 times and skip, then 4 times and skip, he guesses he has a crazy heart.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,02/04/2021,13.0,UNK,ELIQUIS; RANEXA,,"Medical History/Concurrent Conditions: Arterial occlusion (diagnosed several years ago, he guesses he is living on half of them.); Bypass surgery (diagnosed several years ago, he guesses he is living on half of them.); Stent placement (5 stents; diagnosed several years ago, he guesses he is living on half of them.)",,,"['Epistaxis', 'Extrasystoles']",1,PFIZER\BIONTECH, 1057701,TX,,F,"Chills; A spontaneous report was received from a consumer, concerning herself, a 75-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed chills. The patient's medical history was not provided. Concomitant product use was not provided. On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # unknown) in the left arm for prophylaxis of COVID-19 infection. On 17 Jan 2021, after vaccine administration, since Sunday, the patient started experiencing chills. No treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event chill was considered not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/17/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Chills'],1,MODERNA, 1057702,NY,,F,"Herpes Opthlamic Zoster; A spontaneous report was received from a consumer concerning a 42 years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed Herpes Ophthalmic Zoster/MedDRA PT: Ophthalmic herpes zoster. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Lot #not provided) on an unknown date. On 09 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot #, site of injection and route of administration Not provided) for the prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient was diagnosed with Herpes Ophthalmic Zoster. Treatment details were not provided. The patient received both scheduled doses of mRNA-1273 prior to the event ; therefore, action taken with the drug in response to the event is not applicable. The outcome of the event Herpes Ophthalmic Zoster was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,02/11/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Ophthalmic herpes zoster'],1,MODERNA,OT 1057703,,,U,"Gall bladder dysfunction; A spontaneous report was received from a medical assistant concerning a patient of unspecified age and gender, who Moderna's COVID-19 Vaccine (mRNA-1273) and experienced gall bladder dysfunction. The patient's medical history was not reported. Concomitant product use was not provided by reporter. On unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On an unspecified date, after receiving vaccine, the patient experienced gall bladder dysfunction. Hence, due to this reaction the second dose of vaccine was not administered. Treatment information was not provided. Action taken to mRNA-1273 in response to event was temporarily withheld. The outcome of event gall bladder dysfunction was unknown at the time of this report.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Gallbladder disorder'],1,MODERNA, 1057704,FL,,F,"High grade MDS; Multiorgan failure; Pancytopenia; shortness of breath; Inflammatory marker increased; Chills; Fever; Fatigue; A spontaneous report was received from a healthcare provider concerning a 71Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced chills, fever, fatigue, pancytopenia, shortness of breath (dyspnoea), multi organ failure, and myelodysplastic syndrome (MDS). The patient's medical history was reported to include Breast Cancer and mastectomy. No relevant concomitant medications were reported. On 16 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unkown) intramuscularly for prophylaxis of COVID-19 infection. On 16 Jan 2021, The patient experienced events like chills, fever, and fatigue. On an undisclosed date, the patient was admitted to the hospital for shortness of breath. Laboratory details include Bone Marrow biopsy with abnormal results such as showed high grade MDS with 19% blasts. Blood work done with normal results. Body temperature results came out 103 degrees Fahrenheit. On 30 Jan 2021 the patient experienced worsening shortness of breath and was intubated. Her IL-6 was very high, and she had profound liver failure. She ended up needing pressors and requiring continuous renal replacement therapy. Treatment included steroids. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 12 Feb 2021. The cause of death was reported as high grade MDS. An autopsy was planned.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death",Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/16/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Breast cancer (in the 1990s); Mastectomy,,,"['Biopsy bone marrow', 'Blood test', 'Body temperature', 'Chills', 'Computerised tomogram', 'Dyspnoea', 'Fatigue', 'Inflammatory marker increased', 'Interleukin level', 'Laboratory test', 'Multiple organ dysfunction syndrome', 'Myelodysplastic syndrome', 'Pancytopenia', 'Pyrexia']",1,MODERNA,OT 1057705,IA,36.0,F,"Allergic reaction; Syringe malfunctioned and the vaccine ran down patients arm/ noticed there was still some vaccine left in the syringe; Syringe malfunctioned and the vaccine ran down patients arm/ noticed there was still some vaccine left in the syringe; Administered another new dose; A spontaneous report was received on 12 FEB 2021 from a pharmacist concerning a 36-years-old, female patient who received second dose of Moderna's COVID-19 vaccine and had syringe malfunctioned and the vaccine ran down patients arm/ noticed there was still some vaccine left in the syringe developed allergic reaction, heart racing, arm was on fire and throat was itchy and was administered another new dose. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient received their first of two planned doses of mRNA-1273 on 28 Jan 2021 (LOT number: unknown) for COVID-19 infection prophylaxis. On 28 JAN 2021, patients received second dose of mRNA-1273(BATCH/LOT number: 025J20-2A) in the right upper arm for the prophylaxis of COVID-19 infection. On 28 JAN 2021, when patient received the vaccine, the syringe was ""malfunctioned"", and the vaccine ran down patient's arm. Vaccine administrator noticed there was still some vaccine left in the syringe and thought the patient did not receive that dose because it was leaked down patients arm. The patient received another new dose. After receiving vaccine, patient had an allergic reaction, heart racing, arm was on fire and throat was itchy. Treatment for the events provided was diphenhydramine. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event's allergic reaction, heart racing, arm was on fire and throat was were unknown. The outcome of the events syringe malfunctioned, and the vaccine ran down patients arm noticed there was still some vaccine left in the syringe developed and administered another new dose were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Anaphylactic reaction', 'Inappropriate schedule of product administration', 'Incorrect dose administered', 'Syringe issue']",1,MODERNA, 1057706,IL,78.0,F,"Patient has episode of amnesia possibly cause by seizure. Patient also had headache, chills, fatigue.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/04/2021,02/05/2021,1.0,PHM,"Calcium, Vitamin D, no medications",,None.,,,"['Amnesia', 'Chills', 'Computerised tomogram normal', 'Fatigue', 'Headache', 'Magnetic resonance imaging', 'Ultrasound Doppler']",1,PFIZER\BIONTECH,IM 1057709,,,M,"stroke; A spontaneous report was received from a consumer concerning a male patient who experienced a stroke/cerebrovascular accident. The patient's medical history was not provided. Concomitant medications were not provided. On an unspecified date, the patient received one of two planned doses of mRNA-1273 intramuscularly for the prophylaxis of COVID-19 infection. On an unspecified date, the patient reported that he had a stroke. Treatment information was not provided. Action taken with mRNA-1273 was not reported. The outcome of the event, stroke, was not reported/unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. No further information is expected",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse reaction (No reported medical history),,,['Cerebrovascular accident'],1,MODERNA,OT 1057713,OK,56.0,F,"Extreme ITP, platelets <1,000, spontaneous bleeding, bruising, petechiae",Not Reported,,Yes,Yes,9.0,Not Reported,N,01/05/2021,02/09/2021,35.0,PVT,Plaquenil,,"Mixed Connective Tissue Disease, Sjogrens, Antiphospholipid Disease, Rheumatoid Arthritis, ITP",,None,"['Condition aggravated', 'Contusion', 'Full blood count', 'Haemorrhage', 'Immune thrombocytopenia', 'Laboratory test', 'Metabolic function test', 'Petechiae', 'Platelet count decreased']",2,MODERNA,IM 1057717,MN,,M,"the second dose of the vaccine 14 days after the first dose; A spontaneous report was received from a pharmacist regarding a male patient of unreported age that received Moderna's COVID-19 vaccine (mRNA-1273) that received the second dose 14 days after the first/inappropriate schedule of vaccine administered. The patient's medical history was not included. Products known to have been used by the patient were not provided. On 28 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. The second dose was scheduled and given 14 days after the first dose. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events, the second dose being administered 14 days after the first dose, was considered resolved on 11 Feb 2021. The outcome of the events, the second dose being administered 14 days after the first dose, was considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported. Patient received second dose 14 days after the first dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,02/11/2021,14.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical history not provided),,,['Inappropriate schedule of product administration'],1,MODERNA,OT 1057728,CA,36.0,F,"skin is on fire after second dose; swelling in her soft palate after second dose; angioedema after 2nd dose; Ribs were swollen after 2nd dose; tongue was swollen//2nd dose; Covered in hives after 2nd dose; small reaction// 1st dose; A spontaneous report was received from a healthcare facility staff member concerning a 36-year female patient who developed urticaria, angioedema, swollen ribs, swollen tongue, hives that were welts, skin burning and soft palate swelling. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) on 14-JAN-2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection. After the patient's first injection on 14-Jan-2021 the patient developed a small reaction within 45 minutes. The patient received their second of two planned doses of mRNA-1273 (Batch number: 006M20A) on 11-FEB-2021 intramuscularly in the right arm for prophylaxis of COVID-19 infection. After the receiving their second injection on 11-FEB-2021 the patient went to the ER on 12Feb2021. The patient developed angioedema and an epinephrine pen was used. The patient also had swollen ribs, a swollen tongue and hives and was given a steroid shot. The patient then returned to the ER on 14Feb2021 for angioedema. The patient was given intravenous Diphenhydramine, intravenous dexamethasone and intravenous Famotidine. The patient developed hives that became welts, that were bright red in color and burned. The patient described that their skin felt like it was on fire, and there was swelling in their soft palate. The outcome of the events were unknown/not reported.; Reporter's Comments: This case concerns a 36 year old, female patient, who experienced a serious unexpected event of Angioedema, and a few non-serious events, after receiving second dose mRNA-1273 (Lot# 006M20A). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,"['Adverse event', 'Angioedema', 'Bone swelling', 'Palatal disorder', 'Skin burning sensation', 'Swollen tongue', 'Urticaria']",2,MODERNA,OT 1057737,AZ,,M,"infection; suspected gout; huge pain at middle finger on right arm; A spontaneous report received from a consumer who is 33-year-old male patient who received first dose of Moderna COVID-19 vaccine and experienced pain in middle finger of the opposite vaccine arm. The patient's medical history was not provided. Concomitant product use was not provided. On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch #: 032L20A) intramuscularly in the left arm or prophylaxis of COVID-19 infection. Patient stated that he received his 1st dose of the Moderna COVID-19 vaccine on 27 Jan 2021 in his left arm and had no soreness. The next morning, on 28 Jan 2021, he woke up with a huge pain in his middle finger on the right arm. The doctor gave him antibiotics and suspected it was gout. Patient stated he went to his PCP and he asked him to go to emergency room. The patient stated that he was given IV and antibiotics. The patient stated that they did a lot of blood work and blood culture (results not provided). He stated that a 90 min surgery was performed, and he stayed in the hospital for three to four days. The hospital lost the specimen, so he doesn't know what kind of infection he had. The patient stated that he doesn't know if he should receive the 2nd dose of the Moderna COVID-19 vaccine or not. Patient was treated with antibiotics and surgery. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/27/2021,01/28/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Gout', 'Infection', 'Pain in extremity']",1,MODERNA,OT 1057750,PR,69.0,M,"Started feeling unwell; Headaches; Body aches; Chest pain; Didn't had wishes to eat; Diarrhea; COVID-19 pneumonia; A spontaneous report was received from a consumer concerning a 69-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID-19 pneumonia, feeling unwell, headaches, body aches, chest pain, decreased appetite and diarrhea The patient's medical history high blood pressure which was controlled with medication. Concomitant product use included nifedipine and fenofibrate. On 20-JAN-2021, approximately a week and a half or two prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. A week and a half or two later the patient stated feeling unwell, headaches, body aches, chest pain, decreased appetite and diarrhea for which patient was hospitalized on 06-FEB-2021. Since everything seemed to be fine the patient was discharged on an unknown date in FEB-2021 however, patient's family was not notified that it was a late reaction to the vaccine's first dose. Later, due to shortness of breath he was hospitalized again on 08-FEB-2021 and was diagnosed for pneumonia and was intubated on the same day. Due to COVID-19 situation patient's family could not be in the facilities and that there wasn't any follow up of the patient given to the family, so family did not have much information. During the first hospitalization(06-FEB-2021) the patient had a blood test which showed a normal result and was tested for COVID-19 and Influenza, both were negative. During second hospitalization (08-FEB-2021) the hospital said that the patient was stable. The patient's family did not know the results of the tests conducted at the time. The action taken with the vaccine in response to the events is not applicable. The outcome of COVID-19 pneumonia was fatal. The patient died on 14 Feb 2021 The cause of death was reported as COVID-19 related pneumonia. The autopsy was not done.; Reporter's Comments: Very limited information regarding this event has been provided at this time. The cause of death was reported as COVID-19 related pneumonia. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events are assessed as unlikely related. Further information has been requested.; Reported Cause(s) of Death: COVID-19 pneumonia",Yes,02/14/2021,Not Reported,Yes,,Not Reported,N,01/20/2021,02/08/2021,19.0,UNK,PROCARDIA [NIFEDIPINE]; LOFIBRA [FENOFIBRATE],Blood pressure high,,,,"['Blood test', 'COVID-19 pneumonia', 'Chest pain', 'Decreased appetite', 'Diarrhoea', 'Headache', 'Influenza virus test negative', 'Malaise', 'Myalgia', 'Viral test negative']",1,MODERNA,OT 1057765,AZ,,M,"Completely out/eyes were closed; looked like he wasn't breathing; Began to shake, patient's head and arm shocked; Weak; little confused; A spontaneous report was received from a consumer concerning a 69 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced began to shake (MedDRA PT: tremor), head and arm shocked (MedDRA PT: tremor), completely out/eyes were closed (MedDRA PT: loss of consciousness), looked like he wasn't breathing (MedDRA PT: respiratory arrest), weak (MedDRA PT: asthenia), and little confused (MedDRA PT: confusional state). The patient's medical history included stroke. Concomitant product use included unspecified blood pressure pills, cholesterol pills, vitamins, and a drug for the patient's brain due to the stroke. On 17 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot #: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 17 Feb 2021, ten minutes after receiving the vaccination, the patient began to shake, patient's head and arm shocked and patient was completely out with eyes closed. The reporter stated it looked like the patient wasn't breathing. Seven minutes later, the patient was given an epi shot and oxygen. The patient was transported via ambulance to the emergency room (ER). At that time, a scan was performed - nothing was detected in patient's brain. Patient remained in ER from 0830 to 1500. Patient subsequently left ER very weak and a little confused. It was recommended for patient not to receive second vaccination dose. Treatment information included epi shot and oxygen. Action taken with mRNA-1273 in response to the events was not reported. The events began to shake, head and arm shocked, completely out/eyes were closed, and looked like he wasn't breathing were considered resolved on 17 Feb 2021. The events very weak and little confused were not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,UNK,VITAMINS NOS,,Medical History/Concurrent Conditions: Stroke (about 2 months ago),,,"['Asthenia', 'Confusional state', 'Loss of consciousness', 'Respiratory arrest', 'Tremor']",1,MODERNA,OT 1057772,PR,76.0,F,"Patient looses control of it's left side, falls on it's left side and hits their head. Take to the Hospital and is now connected to a mechanical ventilator.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/05/2021,02/06/2021,1.0,OTH,Unknown.,Unknown.,Unknown.,,Unknown.,"['Balance disorder', 'Computerised tomogram', 'Fall', 'Head injury', 'Hemiparesis', 'Laboratory test', 'Mechanical ventilation']",1,PFIZER\BIONTECH,IM 1057778,CA,54.0,F,"After 2nd dose on 2/3/21, I waited 10 minutes and felt tingling and cold, heaviness and blood pressure dropped significantly. They put me onto a gurney and monitored my BP and waited, gave me some juice and crackers, but I continued to have the sensation of fainting (syncope). They transferred me to the ER for further monitoring. After a while, it stabilized more, but still continued to happen throughout the day.",Not Reported,,Yes,Yes,,Not Reported,Y,01/13/2021,02/03/2021,21.0,PVT,"Reclast, Lexapro",None,"Osteoporosis, anxiety",,None,"['Blood pressure decreased', 'Discomfort', 'Dizziness', 'Feeling cold', 'Paraesthesia', 'Syncope']",2,PFIZER\BIONTECH,IM 1057780,PA,32.0,M,Acute myocarditis,Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/29/2021,02/21/2021,23.0,PVT,None,None reported,None reported,,Bactrim,"['Magnetic resonance imaging heart', 'Myocarditis']",1,MODERNA,IM 1057786,TN,53.0,F,"Within 12 hours of receiving my second vaccine, My left leg felt like it internally rotated and started to hurt and feel like lead. On January 28, 2021, I went to the ER and an extensive blood clot (DVT) was found.",Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/26/2021,01/27/2021,1.0,PUB,Valsartan/HCTZ Celexa Singulair Carvedilol Zyrtec,Sinus Infection,HTN Sinus Infections,,,"['Deep vein thrombosis', 'Limb discomfort', 'Pain in extremity', 'Plasminogen activator inhibitor', 'Sensory disturbance', 'Stent placement', 'Thrombosis', 'Vascular operation', 'Vena cava filter insertion']",2,MODERNA,IM 1057795,OH,82.0,F,Death 02/22/2021.,Yes,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,02/22/2021,33.0,PUB,,,,,,['Death'],1,MODERNA,IM 1057802,KY,86.0,M,"Patient was transferred from hospital for further evaluation and care by pulmonologist. He started having symptoms a week before with fatigue, emesis, decreased p.o. intake, shortness of breath, vomiting and diarrhea. The two previous takes before death required increasing oxygen and family wanted everything done including intubation. He was transferred to ICU.",Yes,01/31/2021,Not Reported,Yes,6.0,Not Reported,N,01/19/2021,01/31/2021,12.0,PVT,,,,,,"['Death', 'Decreased appetite', 'Diarrhoea', 'Dyspnoea', 'Endotracheal intubation', 'Fatigue', 'Hypophagia', 'Intensive care', 'Vomiting']",1,MODERNA,IM 1057807,OH,91.0,M,"Resident went out of facility to the Fairgrounds on 2/25/21 for an appointment at 11:30 to receive second dose of Moderna vaccine. Someone from the local Fire Department came to the facility and administered another dose to the patient on 2/25/21 at 3:30pm but actually administered to the wrong patient. on 2/25/21 at 6:20pm, the patient experienced respiratory distress. Pulse oximetry was 85%. BP 175/86. Pulse was 102. Temperature was 102.2. Nurse manager at the facility was notified and when she and the nurse spoke to each other, the patient stated he had two vaccines today. This was when the double dose was discovered. The patient was sent out to the hospital emergency department and was admitted. The patient was on a bipap overnight. Condition has improved this morning.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/25/2021,02/25/2021,0.0,SEN,azithromycin 250mg; warfarin 0.5mg; citalopram 10mg; albuterol sulfate 108 mcg/act two puffs; furosemide 40mg; isosorbide mononitrate 30mg; metoprolol tartrate 12.5mg; lisinopril 2.5mg; aspirin EC 81mg; atorvastatin 10mg; tamsulosin 0.4mg;,upper respiratory infection,"congestive heart failure, arteriosclerotic heart disease, hypertension, atrial fibrillation, benign prostatic hyperplasia",,"hydrochlorothiazide, Vasotec, Crestor, doxycycline","['Bilevel positive airway pressure', 'Blood pressure abnormal', 'Body temperature increased', 'Extra dose administered', 'Heart rate increased', 'Oxygen saturation decreased', 'Pyrexia', 'Respiratory distress', 'Wrong patient received product']",3,MODERNA,IM 1057828,NC,66.0,M,Patient unexpectedly died on 2/17 after 14 days of receiving first dose of COVID-19 vaccine. EMS presumed it could be from possible myocardial infarction.,Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/17/2021,14.0,PVT,"Metformin 1000mg twice daily, Lisinopril 10mg once daily, aspirin 81mg once daily, amlodipine 10mg daily",,"hypertension, type 2 diabetes, prostate cancer, melanoma, lumbar spondylosis, renal stones, GERD",,empagliflozin 10mg caused dizziness,['Sudden death'],1,MODERNA,IM 1057831,MS,48.0,M,"Patient developed sob. Admitted on 2/16/21 with cardiogenic shock, acute renal failure and liver inflammation. Diagnosed with multisystem inflammatory disorder from COVID-19. Thought to be related to diagnosis on 1/25/21 but given recent receipt of vaccine reporting in case there are trends.",Not Reported,,Not Reported,Yes,12.0,Not Reported,Y,02/10/2021,02/14/2021,4.0,PVT,1) ALBUTEROL 90MCG (CFC-F) 200D ORAL INHL INHALE 1 PUFF ACTIVE BY INHALATION EVERY 12 HOURS AS NEEDED FOR RESCUE BREATHING 2) CETIRIZINE HCL 10MG TAB TAKE ONE TABLET BY MOUTH ACTIVE DAILY FOR ALLERGIES 3),Obesity Hypertension Obstructive sleep apnea COVID 19 infection diagnosed on 1/25/21,as above,,Vardenafil,"['Acute kidney injury', 'Aspartate aminotransferase increased', 'Blood creatinine increased', 'C-reactive protein increased', 'Cardiogenic shock', 'Dyspnoea', 'Hepatitis', 'Multisystem inflammatory syndrome in children', 'SARS-CoV-2 antibody test positive', 'Serum ferritin increased', 'Systemic inflammatory response syndrome']",1,MODERNA,IM 1057844,WA,89.0,F,"Stroke in left occipital lobe Feb 1 & Feb 2 Right peripheral vision effected in both eyes 2 heart stops on Feb 10, 2021 Pacemaker implanted after heart stops",Not Reported,,Yes,Yes,3.0,Not Reported,U,01/26/2021,02/01/2021,6.0,UNK,"levoxythorine, magnesium, potassim",0,0,,0,"['Cardiac arrest', 'Cardiac pacemaker insertion', 'Cerebrovascular accident', 'Computerised tomogram', 'Magnetic resonance imaging', 'Visual field defect', 'X-ray']",1,MODERNA,SYR 1057845,FL,76.0,F,"migraines; anxious; headache; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), intramuscularly, on 23Jan2021 at 11:30 (at the age of 76-years-old) as a single dose in the left arm for COVID 19 vaccination. Medical history included stress related to work and a preservatives allergy which give her headaches. Historical vaccinations included pneumonia vaccine (UNKNOWN MANUFACTURER but reported as ""Pneumonia 13"") on an unspecified date ""four years ago"" after which she developed a headache which she attributes to an allergy to unknown preservatives. She never received the second ""Pneumonia 13"" because of the reaction with the first one. She also reported that she has had this same reaction of headache attributed to allergy to unknown preservatives when eating fast foods and foods with sauces. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was administered at a County Convention Center. On 23Jan2021 at 11:45, fifteen minutes after she received the vaccination, the patient developed a headache which she has had ever since she got in on Saturday. She also stated that it feels like ""a migraine on steroids."" She did tell the person at the clinic where she received it. She stated that she is ""hypoallergenic"" and she had to sit for thirty minutes after receiving it. She was already anxious and about fifteen minutes in, she developed the headache and nothing has helped so far. She added that she has not had a headache in a long time and that is why she feels it is the shot. She reported that what she took for treatment did not work. These treatments included: Acetaminophen Extra Strength 500mg NDC 21130-111-90. Lot 9ME2806A, expiration 20Jul2021. Count size is 500 caplets, Motrin Ibuprofen tablets 200mg. Lot 6ME1058A, Expiration Sep2018. Count size 100 caplets which when taken was an expired product, SalonPas Roll On Lot 192498, Expiration Jan2022. Count size is 1 container with 3 fluid ounces or 88ml and Neck Wrap and Wrist Heat Wraps which is reported as ""a generic equivalent of Thermacare"" with Lot number 91211OC16, Expiration 10Dec2022. She did not take the heavy duty Motrin because it was out of date. She commented that all of these things had helped in the past. The clinical outcomes of the event headache, migraine and anxiety were reported as unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,01/23/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Allergy to chemicals (Unknown Preservatives allergy gives her headaches.); Stress at work,,,"['Anxiety', 'Headache', 'Migraine']",UNK,PFIZER\BIONTECH,OT 1057852,,78.0,M,"Dizziness; Hypoglycemia; Hypotension; Generalized rash; This is a spontaneous report from a non-contactable healthcare professional. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318; dose 1) intramuscularly on 25Jan2021 (at the age of 78-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history and concomitant medications were not reported. On 25Jan2021 during the 15 minute waiting period after the vaccine, the patient experienced dizziness. He denied difficulty breathing and swallowing. A differential diagnosis of systemic reaction (hypoglycemia, hypotension, generalized rash) was provided. The patient was given unspecified treatment and follow-up response was good. The patient denied dizziness when standing up and walking to leave the medical evaluation bay and clinical outcome of dizziness was completely resolved prior to discharge. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,UNK,,,,,,"['Dizziness', 'Hypoglycaemia', 'Hypotension', 'Rash']",1,PFIZER\BIONTECH,OT 1057853,CA,64.0,M,on 2/218/2021 the patient was at home and developed chest pain. Patient was transported by family to urgent care then to the ED where the patient later died.,Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/21/2021,3.0,PVT,,,,,,"['Chest pain', 'Death']",1,MODERNA,IM 1057862,,81.0,M,admitted to hospital with STEMI,Not Reported,,Not Reported,Yes,,Not Reported,,02/23/2021,02/26/2021,3.0,PVT,,,,,,['Acute myocardial infarction'],1,MODERNA,IM 1057864,MI,60.0,F,"Strong metallic taste in my mouth about 5-10 min after vaccination (lasted about 45 min); morning stiff shoulders and back of neck (still have it but it's better); This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration on 26Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included PVCs (Premature ventricular contractions), coronary artery disease (CAD) and allergies to NSAIDS, artificial sweeteners, sulfa, and mango. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included nicotinic acid (NIASPAN), vitamin d nos, metoprolol tartrate (LOPRESSOR), omega-3-acid ethyl ester (LOVAZA) and Nexlizet. No any other vaccines received within 4 weeks prior to the COVID vaccine. On 26Jan2021 12:45, the patient experienced strong metallic taste in her mouth about 5-10 min after vaccination and morning stiff shoulders and back of neck (still have it but it's better). No treatment was received for the events. The patient has not been tested for COVID-19 since the vaccination. The patient was recovering from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,UNK,NIASPAN; VITAMIN D NOS; LOPRESSOR; LOVAZA,,Medical History/Concurrent Conditions: Allergic reaction to analgesics; Artificial sweetener intolerance; Coronary artery disease; Food allergy; Premature ventricular contractions; Sulfonamide allergy,,,"['Dysgeusia', 'Musculoskeletal stiffness']",1,PFIZER\BIONTECH, 1057865,NM,64.0,F,"Severe diarrhea for 28 days now; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El0142, expiry date not reported), via an unspecified route of administration at the left arm on 31Dec2020 14:00 at single dose for COVID-19 immunization. Medical history included asthma. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a public health clinic/veterans administration facility. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included prednisone and amoxicillin (AMOXYCILLIN). The patient experienced severe diarrhea for 28 days now on 02Jan2021 10:00. The adverse event resulted to doctor or other healthcare professional office/clinic visit as well as emergency room/department or urgent care. No therapeutic measure was taken as a result of the events. Clinical outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/02/2021,2.0,PUB,PREDNISONE; AMOXYCILLIN,,Medical History/Concurrent Conditions: Asthma,,,['Diarrhoea'],1,PFIZER\BIONTECH, 1057866,,,M,"tooth ache; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a tooth ache on unspecified date and after he got the shot they told him not to take paracetamol (TYLENOL) or anything, but didn't say for how long. He need to know if he can take paracetamol. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,,,UNK,,,,,,['Toothache'],1,PFIZER\BIONTECH, 1057867,,,F,"I experienced a very bad headache; This is a spontaneous report from a contactable consumer (patient). A (Age: 84; Unit: Unknown) female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a very bad headache that night after the shot. The outcome of event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Headache'],1,PFIZER\BIONTECH, 1057868,MA,,U,"toothache; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced toothache on an unspecified date. Therapeutic measures included paracetamol (TYLENOL). The outcome of event was unknown. Information on Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Toothache'],1,PFIZER\BIONTECH, 1057869,VA,,M,"developed COVID symptoms/after getting the first dose, the patient tested positive for COVID; developed COVID symptoms/after getting the first dose, the patient tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that after getting the first dose, the patient tested positive for COVID. The patient developed COVID symptoms on an unspecified date (reported as 11 days ago). During the day of the report, it was day 10 of having symptoms of COVID and being quarantined. The day after the report will be day 11 (as reported) and he has no lingering symptoms and feels fine and CDC says you are clear after 10 days. He is currently symptom free and wants to knows if he is eligible to receive the second dose. The outcome of the events was unknown. The events were reported as non-serious. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Drug ineffective', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1057870,MA,,F,"period bleeding very intense suddenly; This is a spontaneous report from a non-contactable healthcare professional reporting for a patient. An adult female patient, not pregnant at vaccination time, received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EK9231), on 10Feb2021 at 03:30 AM at single dose in Left arm for COVID-19 immunisation. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient had no relevant medical history. The patient is allergic to sulfamethoxazole trimethoprim (BACTRIM). Concomitant medications included vitamins. On 11Feb2021 at 06:30 AM the patient experienced period bleeding very intense suddenly next morning after vaccine. The event was reported as non serious. No treatment was received for the event. The patient had not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/11/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['Menorrhagia'],1,PFIZER\BIONTECH, 1057871,MN,30.0,M,"Intense nausea; diarrhoea; headache; chills; body aches; intense fatigue; body weakness; This is a spontaneous report from a non-contactable healthcare professional who reported for himself, a 30-year-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581), via an unspecified route of administration left arm, on 08Feb2021 at 12:15, at the age of 30 years, at a single dose for COVID-19 immunization. Medical history included COVID-19. The patient had no known allergies. The patient's concomitant medications were not reported. On 09Feb2021 at 03:00, the patient experienced intense nausea, diarrhoea, headache, chills, body aches, intense fatigue and body weakness. Lasting at moderate/severe intensity for about 10 hours, and mild/moderate intensity for 8 more hours. The patient tested positive for COVID-19 and fully recovered about a month prior to the vaccination. The patient stated that this felt very similar to the first day of having COVID-19, except more intense. The reported considered the events as non-serious. Tylenol was received as treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The events recovered on an unspecified date in Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/09/2021,1.0,PUB,,,Medical History/Concurrent Conditions: COVID-19 (tested positive for COVID-19 and fully recovered about a month prior to the vaccination),,,"['Asthenia', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1057872,FL,84.0,M,"my temperature and it's at 99.3 F/a little fever; weak; I didn't have appetite; This is a spontaneous report from a contactable consumer (patient). An 84-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9264) via an unspecified route of administration on the left arm on 08Feb2021 at a single dose for COVID-19 immunization and apixaban (ELIQUIS) via an unspecified route of administration from an unspecified date and ongoing at an unspecified dose and frequency for an unspecified indication. Medical history included afib and heart rate (abnormal). Concomitant medication included propranolol hydrochloride (MANOPROLOL) for afib. The patient previously received first dose of BNT162B2 on 18Jan2021 for COVID-19 immunization (lot: EL1283 on the left arm) and experienced a little bit of soreness at the injection site. The patient took his temperature and it was at 99.3 F. Patient asked, ""Is that within range? Can I take Tylenol?"" The patient stated that when he first got his shot of the Pfizer Covid Vaccine at the (Hospital name) in (City name) he didn't have any problems or didn't experience any side effects. Then after receiving his 2nd shot on 08Feb2021, he mentioned that he started having trouble. On 10Feb2021, he started to experience some side effects and stated, ""I was as weak as I could be, I didn't have appetite and I had a little fever. I just feel super weak but not like if you have corona. Now, I can sleep under oxygen and it doesn't bother me anymore and when I get up I don't need oxygen anymore and I can breathe freely."" Wanted to know how long will his symptoms last. He was as weak as a rag, has a little fever that comes and goes, does not go over 101, stated he was taking Eliquis does not know if that was important or not, slept with oxygen but has not had any trouble breathing. Wondering if this was standard. The action taken for apixaban was unknown. Outcome of the event 'didn't have appetite' was unknown and not recovered for the other events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/10/2021,2.0,UNK,MANOPROLOL,,Medical History/Concurrent Conditions: AFib; Heart rate abnormal,,,"['Asthenia', 'Body temperature', 'Decreased appetite', 'Pyrexia']",UNK,UNKNOWN MANUFACTURER, 1057873,OR,42.0,F,"Face numb and tingly for several hours; Face numb and tingly for several hours; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date not reported), via an unspecified route of administration at the right arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Medical history included penicillin allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included carbamazepine and quetiapine. On 01Feb2021 16:00, the patient experienced face numb and tingly for several hours. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date in Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,UNK,CARBAMAZEPINE; QUETIAPINE,,Medical History/Concurrent Conditions: Penicillin allergy (known_allergies: Penicillin),,,"['Hypoaesthesia', 'Paraesthesia']",1,PFIZER\BIONTECH, 1057874,IA,53.0,F,"Raised swollen lump at injection site; muscle and joint aches; muscle and joint aches; fatigue; headache; nausea; lack of appetite and energy; lack of appetite and energy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 10Feb2021 13:00 at a single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, High blood pressure, arthritis, obese, anxiety, depression. Concomitant medication included lamotrigine, duloxetine hydrochloride (CYMBALTA), ropinirole hydrochloride (REQUIP) and unspecified blood pressure meds. On 12Feb2021, the patient experienced raised swollen lump at injection site, muscle and joint aches, fatigue, headache and nausea, lack of appetite and energy. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has been tested for COVID-19, nasal swab on 04Dec2020: negative. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/12/2021,2.0,UNK,LAMOTRIGINE; CYMBALTA; REQUIP,,Medical History/Concurrent Conditions: Anxiety; Arthritis; Blood pressure high; Depression; Obesity; Sulfonamide allergy,,,"['Arthralgia', 'Asthenia', 'Decreased appetite', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'SARS-CoV-2 test', 'Vaccination site mass']",UNK,PFIZER\BIONTECH, 1057875,AZ,58.0,F,"I saw bright red dots &dot clusters on both legs; Petechiae; This is a spontaneous report from a contactable consumer reported for herself. A 58-years-old female patient (not pregnant at the time of vaccination) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9262, via an unspecified route of administration on 02Feb2021 13:30 in left arm at single dose for covid-19 immunisation. Medical history included known allergies: Amoxicillin (all penicillin family), she had AT III deficiency (a hereditary blood clotting disorder) that she had been taking warfarin for 23 years never any issues or clots since. she had never had a reaction to any vaccines before. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included warfarin for AT III deficiency and 1 multi vitamin. The patient previously took amoxicillin and experienced allergies. On 02Feb2021 the patient got the vaccine at 1:30pm. At 5:30 pm, she saw bright red dots and dot clusters on both legs (not sure when it started, reported as 02Feb2021 05:00 PM) all dots were under the surface of her skin. They didn't itch nor hurt and were not detectable by touch. She took a few pictures. Next day they were still there and hadn't increased or decreased. The next day Thursday, she went to her PCP Dr (Name) got blood work and results came back normal. He thought it to be petechiae but not sure why. Each day the red dot/clusters turned more purple and within 5-7 days had faded away. Dr. (Name). said if with the second vaccine dose, she got worse dot/clusters that worry her, she was to come back. On 12Feb2021 she had an appt with her hematologist Dr (Name), after discussing and looking at the pictures (knowing that she had never had this before) she said it was not related to her medical condition-AT3 deficiency, it didn't look like petechiae. She said it was a reaction to the vaccine, to report it and get advice from you folks before got the second dose. There was no treatment received. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Feb2021. The events were reported as non-serious by the reporter.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,UNK,WARFARIN,,Medical History/Concurrent Conditions: Antithrombin III deficiency (AT III deficiency (a hereditary blood clotting disorder) that I have been taking warfarin for 23 yrs); Penicillin allergy,,,"['Blood test', 'Petechiae', 'Rash macular']",1,PFIZER\BIONTECH, 1057876,MI,30.0,F,"Painful left arm (where vaccinated); flu like aches; feeling cold; This is a spontaneous report from a contactable consumer reporting for herself. A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 10Feb2021 at single dose in Left arm for COVID-19 immunisation. Medical history included coeliac disease from an unknown date. There were no Allergies to medications, food, or other products. The patient was not Pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), on 20Jan2021 at the age of 30-year-old at single dose in Left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Painful left arm (where vaccinated). She experienced flu like aches the day after vaccination as well as feeling cold on 11Feb2021. Since the vaccination, the patient had not been tested for COVID-19There was no treatment received for the adverse event. The outcome of events was recovered. The events were reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/11/2021,1.0,WRK,,,Medical History/Concurrent Conditions: Celiac disease,,,"['Feeling cold', 'Influenza like illness', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1057877,MA,43.0,F,"swollen lymph node the size of an egg under my left arm; temp of 100.8; chills; body aches; can't comprehend conversations (needing to ask the person talking to me to repeat 2 times); getting snappy almost because they repeated it; Felt a few times while standing/walking I could all the sudden fall asleep; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264, expiry date unknown), via an unspecified route of administration on the left arm, on 09Feb2021, at single dose, for COVID-19 immunisation, at a nursing home. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC), budesonide, formoterol fumarate (SYMBICORT), and ethinylestradiol, norethisterone (ALYACEN). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EV3247, expiry date: unknown) received at age 49 years, via an unspecified route of administration on the left arm, on 19Jan2021 10:30, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 11Feb2021 at 08:00, the patient experienced ""swollen lymph node the size of an egg under my left arm, I had a temp of 100.8, chills and body aches. I have felt like I can't comprehend conversations (needing to ask the person talking to me to repeat 2 times, then getting snappy almost because they repeated it) and felt a few times while standing/walking I could all the sudden fall asleep but then few minutes later I feel normal and alert again."" The patient had no headache or foggy head feelings. No treatment was given for the events. The outcome of somnolence was resolved, outcome for the rest events was not resolved. The reporter assessed the events as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/11/2021,2.0,SEN,ZYRTEC; SYMBICORT; ALYACEN,,,,,"['Body temperature', 'Chills', 'Cognitive disorder', 'Irritability', 'Lymphadenopathy', 'Pain', 'Pyrexia', 'Somnolence']",2,PFIZER\BIONTECH, 1057878,CA,52.0,M,"Pain in left testicle; This is a spontaneous report from a contactable consumer or other non hcp. A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration left arm single dose on 11Feb2021 16:30 for covid-19 immunisation. No other vaccine was received in four weeks. Medical history was none. The patient's concomitant medications were not reported. The patient experienced pain in left testicle on 12Feb2021 16:45. No treatment received. The outcome was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/12/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Testicular pain'],1,PFIZER\BIONTECH, 1057879,ME,56.0,F,"burning pain in my left armpit/burning pain in both armpits; extreme fatigue; muscle pain; dizziness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 56-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN9581) via an unspecified route of administration on 11Feb2021 09:00 at single dose in left arm for COVID-19 immunisation. She received the first dose BNT162B2 (lot number: EL8982) in Left arm on 22Jan2021 06:00 PM for COVID-19 immunisation. Medical history included depression, high blood pressure, thyroid disorder, obesity. The patient was allergic to codeine and pennicilian. The patient was not pregnant at the time of vaccination. Concomitant medication included fluoxetine hydrochloride (PROZAC), lisinopril, levothyroxine, bupropion hydrochloride (WELLBUTRIN), omeprazole (OMEP). The patient previously took the first dose of Shingrix (lot number: 5816001912) 50 mcg on Dec2020 in left arm for immunisation. On 12Feb2021 09:00, 24 hrs post 2nd vaccine BNT162B2, the patient experienced extreme fatigue, muscle pain, dizziness and 36 hrs after the second vaccine (12Feb2021 21:00) she also started having burning pain in her left armpit, and the next morning also burning pain in both armpits. No treatment received for the adverse event. Events outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/12/2021,1.0,PVT,PROZAC; LISINOPRIL; LEVOTHYROXINE; WELLBUTRIN; OMEP [OMEPRAZOLE],,Medical History/Concurrent Conditions: Blood pressure high (high bp); Depression; Obesity; Penicillin allergy (known_allergies:pennicilian); Thyroid disorder (thyroid),,,"['Axillary pain', 'Dizziness', 'Fatigue', 'Myalgia']",2,PFIZER\BIONTECH, 1057880,CT,37.0,F,"tiredness; chills; headache; achiness of joints; congestion(hard to breathe); This is a spontaneous report from a contactable consumer (patient). A 37-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot # EL-3247, in Workplace clinic, via an unspecified route of administration on 11Feb2021 at 23:30 (at 37 years of age) at single dose in left arm for COVID-19 immunization. The patient's medical history was not reported. The patient didn't receive any concomitant medication. The patient was not pregnant at the time of vaccination. She had received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot # EL-3247, via an unspecified route of administration on 21Jan2021 at 23:30 (at 37 years of age) at single dose in left arm for COVID-19 immunization. She was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 11Feb2021 at 20:00 (to be clarified) the patient experienced tiredness, chills, headache, achiness of joints and congestion (hard to breathe). The patient didn't receive any treatment. The reported events were resolving at the time of the report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,WRK,,,,,,"['Arthralgia', 'Chills', 'Dyspnoea', 'Fatigue', 'Headache']",2,PFIZER\BIONTECH, 1057881,VA,73.0,F,"Fever 101.9; severe headache; muscle aches; joint pain; weakness; brain fog; lethargy; nausea; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at 10:30 at single dose in right arm for COVID-19 immunisation at the age of 73-year-old. Lot number was EM9810. The patient was not pregnant at the time of vaccination. Medical history included asthma, psoriasis, psoriatic arthritis, cardiac arrhythmia. Past drug history included allergy to Tetracycline. Concomitant medications included metaprolol, montelukast sodium (SINGULAR), simethicone (PEPSID), clonixin lysinate (SKELAXIN), Vitamin D. On 04Feb2021, the patient experienced fever 101.9, severe headache, muscle aches, joint pain, weakness, brain fog, lethargy, nausea. Fever and headache continue 9 days after the injection. On 11Feb2021, Covid test at one week was negative (nasal swab). The patient was treated with Tylenol. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,UNK,METOPROLOL; SINGULAIR; PEPSIDOL; SKELAXIN; VITAMIN D,,Medical History/Concurrent Conditions: Asthma; Cardiac arrhythmia; Psoriasis; Psoriatic arthritis,,,"['Arthralgia', 'Asthenia', 'Body temperature', 'Feeling abnormal', 'Headache', 'Lethargy', 'Myalgia', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1057882,MI,72.0,F,"shot site was red and swollen; shot site was red and swollen; Area felt warm; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Right arm (at age of 72-year-old) on 03Feb2021 at 03:15 PM as a single dose for COVID-19 immunisation, lot number: EN5318. Medical history included breast cancer from Dec1995. Patient previously received prochlorperazine (COMPAZINE) and experienced allergy. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Concomitant medications in two weeks prior to the vaccination included sumatriptan nasal spray and Vitamin D NOS. Prior to vaccination the patient was not diagnosed with COVID-19. On 11Feb2021 (also reported as on day 8) at 05:00 PM after vaccine shot site was red and swollen. Area felt warm, no previous discomfort. Symptoms have continued for 48 hours. No treatment was received for the events. Since the vaccination patient had not been tested for COVID-19. Patient had not recovered from the events, at the time of the report.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/11/2021,8.0,PUB,SUMATRIPTAN; VITAMIN D NOS,,Medical History/Concurrent Conditions: Breast cancer (Hx Breast cancer),,,"['Vaccination site erythema', 'Vaccination site swelling', 'Vaccination site warmth']",1,PFIZER\BIONTECH, 1057883,CA,58.0,M,"pain and rash at injection site; pain and rash at injection site; body aches; joint pain; chest pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A 58-year-old male nurse received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Feb2021 at 15:00 at single dose in right arm for COVID-19 immunisation at the age of 58-year-old. Lot number was el1283. Medical history included allergy to penicillin, diabetes, Hypertension, Covid-19 (covid long haulers). Concomitant medications were unknown. On 12Feb2021, the patient experienced pain and rash at injection site, body aches, joint pain, chest pain, fatigue. The patient was not treated for the events. The patient did not recover from the events. Prior to vaccination, the patient was diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/12/2021,1.0,PVT,,,"Medical History/Concurrent Conditions: COVID-19 (if covid prior vaccination: Yes, covid long haulers); Diabetes; Hypertension (htn); Penicillin allergy (known_allergies : PCN)",,,"['Arthralgia', 'Chest pain', 'Fatigue', 'Pain', 'Vaccination site pain', 'Vaccination site rash']",1,PFIZER\BIONTECH, 1057884,IL,44.0,F,"BCG vaccine site/mark became red on 14Feb2021 after 2nd dose.; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL9265), via an unspecified route of administration on 12Feb2021 16:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on 21Jan2021 05:00 PM at left arm at age of 44 years old with lot number EL1283. Patient is not pregnant at the time of vaccination. The facility type vaccine was Doctor's office/urgent care. The patient medical history was not reported. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included omeprazole, levothyroxine, montelukast sodium (SINGULAIR). The patient experienced BCG vaccine site/mark became red on 14Feb2021 after 2nd dose. No itching as of now. Did not happen after 1st dose. It's been red for few hours now. There was no treatment received for the adverse event. The outcome of event was unknown. The event was reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/14/2021,2.0,OTH,OMEPRAZOLE; LEVOTHYROXINE; SINGULAIR,,,,,['Vaccination site erythema'],2,PFIZER\BIONTECH, 1057885,ME,,M,Pneumonia; This is a spontaneous report from a contactable consumer (patient) Pfizer-sponsored program. A male consumer of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. It was reported that on 02Mar2021 patient was scheduled for second shot and he will also receive Novocaine for pneumonia. The outcome of the event was unknown. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,,,UNK,,,,,,['Pneumonia'],1,PFIZER\BIONTECH, 1057887,MA,48.0,F,"chills; moderate shoulder pain at injection site/shoulder pain; severe headache for 28 hours; axillary rash under armpit/painful armpit rash; burning on injection on left arm; This is a spontaneous report from a contactable other healthcare professional (who is also the patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266, expiry date unknown), intramuscular on the left arm, on 12Feb2021 16:00, at single dose, for COVID-19 immunization, at the pharmacy/drug store. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. There were no allergies to medications, food, or other products. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date: unknown) received at age 48 years, intramuscular on the left arm, on 22Jan2021 15:45, for COVID-19 immunization and the patient experienced moderate shoulder pain on injection arm. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 12Feb2021 at 16:00, the patient experienced burning on injection on left arm. On 12Feb2021 at 19:45, the patient experienced moderate shoulder pain at injection site for 24 hours and there was no shoulder pain 36 hours after the injection 14Feb2021 at 04:00; severe headache for 28 hours; and axillary rash under armpit/painful armpit rash which was still present 45 hours after the injection. On 13Feb2021 at 20:00 (reported as 28 hours after injection), the patient experienced chills which lasted for 2 hours. The patient was not tested for COVID-19 since the vaccination. No treatment was given for the events. The patient recovered from chills on 13Feb2021 at 22:00, severe headache on 13Feb2021 at 23:45, and moderate shoulder pain at injection site/shoulder pain on 14Feb2021 at 04:00. The outcome of burning on injection on left arm, axillary rash under armpit/painful armpit rash was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,PHM,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Rash', 'Vaccination site pain']",2,PFIZER\BIONTECH,OT 1057921,CA,71.0,M,Pt presented in v-fib arrest. V fib arrest thought to be secondary to hyperkalemia from DKA. Pt w hx of pre-diabetes w hub A1c 6 for years ( not on meds) but came in w blood sugar 1386. C-peptide levels checked and undetectable. Anti-GAD-65 Ab came back positive,Not Reported,,Yes,Yes,13.0,Not Reported,Y,01/22/2021,01/31/2021,9.0,PVT,"Allopurinol 300mg po daily, Clobetasol 0.05% ointment apply bid, Diclofenac EC 50mg po bid prn, Lisinopril-Hctz 10/12.5mg po q AM, SECUKINUMAB 300mg subQ q 28days, Tamsulosin 0.4mg po qhs, simvastatin 20mg po ohs",,"psoriasis, gout, hypertension, gout, hyperlipidemia",,Sulfamethaxazole,"['Anti-GAD antibody positive', 'Blood glucose abnormal', 'Blood potassium increased', 'Cardiac arrest', 'Diabetic ketoacidosis', 'Glycosylated haemoglobin increased', 'Hyperkalaemia', 'Insulin C-peptide decreased', 'Ventricular fibrillation']",1,PFIZER\BIONTECH,IM 1057956,CA,67.0,M,Heard through a family member had some feeling badly and some respiratory symptoms. We do not have any real information. This is a coroners case.,Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/16/2021,0.0,PVT,unknown,unknown,unknown,,"unknown, not reported","['Feeling abnormal', 'Respiratory symptom']",2,PFIZER\BIONTECH,IM 1057997,SC,69.0,M,"""Feeling Hot"" without fever and nausea 10 hours post vaccine and resolved within 1 hour. Seizure, Hypotension, Unresponsive followed shortly by cardiac arrest and pulseless electrical activity 21 hours post vaccine. Pronounced dead 22 hours post vaccine",Yes,02/26/2021,Yes,Not Reported,,Not Reported,N,02/25/2021,02/26/2021,1.0,PHM,Ibuprofen,None,Prostate Cancer and High Cholestrol,,Penicillin,"['Autopsy', 'Cardiac arrest', 'Death', 'Feeling hot', 'Hypotension', 'Pulseless electrical activity', 'SARS-CoV-2 test', 'Seizure', 'Unresponsive to stimuli']",1,MODERNA,IM 1058008,PA,45.0,M,"Diffuse urticarial rash, fevers, tachycardia, transient hypotension, body aches",Not Reported,,Not Reported,Yes,,Not Reported,N,02/24/2021,02/24/2021,0.0,PVT,"Servino, Lisinopril, Halobetasol, Flonase and clobtasol","eczema, HTN",,,shellfish,"['Hypotension', 'Pain', 'Pyrexia', 'Tachycardia', 'Urticaria']",2,MODERNA,IM 1058009,MI,86.0,M,Patient contracted COVID-19 8 days after administration of 2nd dose of Pfizer COVID-19 vaccine - confirmed with nasal PCR,Not Reported,,Not Reported,Yes,,Not Reported,U,02/16/2021,02/24/2021,8.0,PVT,,,"CAD, Asthma, BPH, Depression, mild MV regurgitation, mild AV sclerosis, obese (BMI 32)",,NKDA,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 1058028,MI,64.0,F,"Moderna COVID-19 Vaccine EUA adverse event. Approximately 7 hours after the 1st COVID vaccination on 2/22/2021, patient developed symptoms of fatigue, aches, chills & fever. Her symptoms worsened into 2/23/21 with increasing shortness of breath. On arrival in the emergency center on 2/23/21, she was hypoxic with SpO2 81% on room air. Oxygen supplement via nasal cannula was given which improved her oxygenation. Covid 19 test negative. Chest Xray shows pulmonary edema and CTA chest shows no PE. She was admitted to the hospital and provided supportive care. Pulmonary Edema and inflammatory process is likely associated with the vaccine. Patient appeared to be improving, however, on 2/26/21, she was working with Physical Therapy/Occupational Therapy and had a pulse ox reading of 75% on room air. She was on 10 Liters of oxygen via nasal cannula by the time she make it back to bed and her pulse ox was 89%. Neurology exam shortly afterward the above event demonstrated an NIHSS of 21. Patient became non-verbal and stat imaging revealed an acute hemorrhage in the left occipatal lobe likely representing a SAH. Patient then transferred to another hospital that could provide neurosurgical intervention.",Not Reported,,Yes,Yes,,Not Reported,N,02/22/2021,02/22/2021,0.0,PUB,"cetirizine tablets, fluticasone nasal spray, folic acid tablet ammonium lactate cream, isosorbide nitrate, lisinopril, metoprolol, nifedipine, semaglutide, sitagliptin, metformin, chlorthalidone",,"Diabetes mellitus, type 2; Hypertension",,none,"['Adverse event following immunisation', 'Angiogram pulmonary normal', 'Apraxia', 'Cerebral infarction', 'Chest X-ray abnormal', 'Chills', 'Computerised tomogram abnormal', 'Dyspnoea', 'Fatigue', 'Haemorrhage', 'Hypoxia', 'Imaging procedure abnormal', 'Inflammation', 'Lack of spontaneous speech', 'NIH stroke scale score increased', 'Neurological examination abnormal', 'Oxygen saturation', 'Oxygen saturation decreased', 'Pain', 'Pulmonary oedema', 'Pyrexia', 'SARS-CoV-2 test negative', 'Subarachnoid haemorrhage']",1,MODERNA,IM 1058033,CA,94.0,F,"Patient had a stroke two days after vaccine. Recevied TPA for treatment of stroke due to acute onset of altered mental status. Had a history of afib, not on anticoagulation, which is likely cause of stroke. Family opted for comfort measures given poor neurologic status. Passed awaiting hospice placement",Yes,02/22/2021,Not Reported,Yes,,Not Reported,N,02/16/2021,02/18/2021,2.0,UNK,"Xanax, celecoxib, lexapro, lisinopril, mirtazapine, zolpidem valsartan",afib,afib,,Sulfa,"['Angiogram cerebral', 'Cerebrovascular accident', 'Computerised tomogram head', 'Death', 'Mental status changes', 'Neurological decompensation']",UNK,UNKNOWN MANUFACTURER,UN 1058049,OH,48.0,F,"She developed new onset acute psychosis. Was admitted to hospital for management and monitored overnight with head imaging, labs and an EEG that did not show any seizure activity. Psychosis appears to have resolved over past 24 h (several days after injection) - d/c from hospital last night 2/25.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/23/2021,02/24/2021,1.0,PVT,"keppra, vimpat, trental, zonegran, protonix, compazine, zofran, norco, ativan, metoprolol, celebrex, zoloft",metastatic lung CA with mets to brain and radiation necrosis causing seizures,metastatic squamous cell carcinoma lung CA (brain mets) brain radiation necrosis asthma celiac disease,,"shellfish, vancomycin, azithromycin, codeine, egg, gluten, meperidine, metoclopramide, pencillin, sulfa","['Acute psychosis', 'Computerised tomogram', 'Computerised tomogram head', 'Electroencephalogram normal', 'Laboratory test']",2,MODERNA,IM 1058142,CA,79.0,F,"2 episodes in which she wanted to pass out; Ache; Flu like symptoms; Fever; A spontaneous report was received from a consumer, concerning herself, a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, aches, flu like symptoms and 2 episodes in which she wanted to pass out. The patient's medical history was not provided. Concomitant product use was not provided. On 08 Feb 2021, the patient received their first of two planned doses of mRNA-1273 ([LOT# 007M20A]) intramuscularly for prophylaxis of COVID-19 infection. On 08-Feb-2021, the patient reported that about 1 to 2 hours after receiving the vaccine, the patient reported that she ""wanted to pass out"" when she went grocery shopping. The patient also had fever, aches and flu-like symptoms. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events of fever, aches, flu like symptoms and ""2 episodes in which she wanted to pass out"", were considered resolved on an unspecified date in Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Influenza like illness', 'Myalgia', 'Presyncope', 'Pyrexia']",1,MODERNA,OT 1058143,FL,63.0,M,"Blood stain streaks bright red in feces; Nausea; fatigue; Headache; Diarrhoea; Feeling gassy; Fever; Vomiting yellow bile; A spontaneous report was received from a consumer regarding a 63-year-old male patient who received Moderna covid-19 vaccine and have experienced blood stain in faeces, vomiting, nausea, headache, flatulence, fatigue and fever. The patient's medical history was not provided. His concomitants include Baby aspirin (blood thinner),Potassium(for low potassium),Gabapentin(for pain),VitB12(for nerves),Duloxetine Hcl (Neuropathy),Doxazosin Mesylate ( for prostrate),Lisinopril(for hypertension),Simvastatin(for cholesterol) and Alprazolam(anti-anxiety).No information on allergies. On 10-FEB-2021, prior to the onset of events, the patient received his first of two planned doses of covid-19 vaccine intramuscularly for the prophylaxis of covid-19 infection (Lot#015M20A). On 11-FEB-2021, he vomited yellow bile looking stuff, had diarrhea, fever and felt gassy. On 12-FEB-2021, he no longer felt vomiting, but felt nauseous, slight fever, fatigue and headache. On 13-FEB-2021, he felt nauseous and had blood stained faeces (bright red). Caller was informed to consult physician for treatment and her question regarding second dose for her husband. Action taken with 2nd dose of Moderna Covid-19 vaccine was not reported. The outcome of the event vomiting is recovered, but other events are not recovered at the time of report.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/11/2021,1.0,UNK,BABY ASPIRIN; POTASSIUM; GABAPENTIN; VITAMIN B12 [CYANOCOBALAMIN]; DULOXETINE HCL; DOXAZOSIN [DOXAZOSIN MESILATE]; LISINOPRIL; SIMVASTATIN; ALPRAZOLAM,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Diarrhoea', 'Fatigue', 'Flatulence', 'Haematochezia', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,OT 1058144,NJ,79.0,F,"vasculitis; coughing up blood; really bad head cold; dizzy; Started gettting sick; A spontaneous report received from a Consumer concerning, 79-year-old, female patient who received dose of Moderna COVID-19 vaccine experienced Vasculitis. The patient's medical history included Afib. Patient's concomitant included Eliquis. On 04FEB2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in left arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Patient daughter reports her mother who is 79-year-old female with no underlining health issues other than Afib, which she takes blood thinners for has been in ICU since 10FEB2021. Patient daughter stated that she was told her mother has vasculitis as a result of the Moderna Covid-19 vaccine. Patient daughter stated that her mother started getting sick on 06Feb2021. She stated her mother started coughing up blood on Sunday 07FEB2021. She stated her mother also had a bad head cold and was dizzy. Patient daughter stated that her mother has some genetic predisposition and the Moderna COVID-19 vaccine triggered it. Patient daughter stated that her mother doctor advised her not to receive the 2nd dose of the Moderna COVID-19 vaccine. Patient treatment included Chemotherapy Infusion (Rituxan) and Blood Transfusion. Action taken with mRNA-1273 in response to the event was withdrawn. The outcome of the event was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/04/2021,02/06/2021,2.0,UNK,ELIQUIS,AFib,,,,"['Dizziness', 'Haemoptysis', 'Nasopharyngitis', 'Vaccination complication', 'Vasculitis']",1,MODERNA,OT 1058145,TX,52.0,F,"fever; fainting spell; fatigue; cough; headache; myalgias; Case reference number MOD-2021-013971 is a spontaneous case report sent by a Physician on 25-JAN-2021 00:00:00 , which refers to a Female aged 52 Years . On 24-Dec-2020 the patient took Moderna COVID-19 vaccination. Some 2 days later, the patient developed fainting. The next day of vaccination the patient also developed cough,headache,myalgia,fever,fatigue. The patient experienced the following serious criteria: Medically Significant. The eventual diagnosis made on was Syncope . The Physician did not declare any relatedness between fainting and Moderna COVID-19 Vaccine. The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons � (probably due to pre existing disease); there is no plausible mechanism to implicate the drug. . Terse Narrative (for narratives and signal review) Brief 3 line summary of above for Regulatory Authority listing: Report Source- Physician, Age- 52 Years, Sex- Female, Suspect Drug- Moderna COVID-19 Vaccine, Treatment- Diagnosis\Outcome- fatigue - Recovered/Resolved,fainting - Recovered/Resolved,fever - Recovered/Resolved,myalgias - Recovered/Resolved,headache - Recovered/Resolved,cough - Recovered/Resolved.; Reporter's Comments: Patient ID: Investigator Site: Case reference number MOD-2021-013971 is a clinical trial case report which refers to a 52 Years old Female patient. The patient experienced fainting which resulted in medically significant . . The patients started Moderna COVID-19 Vaccine on . Some 2 days later, the patient developed fainting.' Relevant laboratory results included and relevant physical signs were . The patient experienced the following serious criteria: -Medically Significant The eventual diagnosis made was Syncope .The event(s) were: fatigue - Recovered/Resolved,fainting - Recovered/Resolved,fever - Recovered/Resolved,myalgias - Recovered/Resolved,headache - Recovered/Resolved,cough - Recovered/Resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/24/2020,12/25/2020,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Cough', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia', 'Syncope']",1,MODERNA,OT 1058146,,72.0,M,"Slurry speech; Swollen tongue; Sore arm; A spontaneous report was received from a consumer concerning a male patient of 72 year old, who was received Moderna's COVID-19 vaccine(Mrna-1273) and experienced sore arm,slurry speech and swollen tongue. The patients medical history,as provided by the reporter, included chemotherapy.No Concomitant medications were reported. On 12 feb 2021,prior to the onset of events, the Patient received their second of two planned dose of Mrna-1273(Lot number:026L20A) vaccine intramuscularly for prophylaxis of COVID-19 infection. On 12 feb 2021,after taking vaccine patient experienced soreness in arm.On the second day he woke up with slurry speech and swollen tongue. Patient was Admitted emergency room where he was kept overnight for observation and treatment. Treatment for the event included hospitalization. The outcome for the event sore arm,blurred speech and swollen tongue was not mentioned.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/18/2021,02/12/2021,25.0,UNK,,Chemotherapy,,,,"['Dysarthria', 'Pain in extremity', 'Swollen tongue']",2,MODERNA,OT 1058147,FL,88.0,M,"Two complex seizures; An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: UNKNOWN) via an unspecified route of administration on 06Feb2021 (at the age of 88-years-old) as a single dose for COVID-19 immunization. Medical history included atrial flutter from an unspecified date and unspecified if ongoing. It was reported that the patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (within two weeks) included warfarin sodium (COUMADIN). It was reported that the patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccination. The patient experienced two complex seizures, serious for hospitalization, on 10Feb2021. The clinical course was reported as follows: ""Two complex seizures confirmed by ED (emergency department) physician. No history of seizures. Negative CT head and labs. Unclear if seizure was related to COVID vaccine 5 days prior."" It was reported that treatment was not received for the event. The clinical outcome of the event two complex seizures was recovered/resolved on an unspecified date. It was also reported that the patient had not tested positive for COVID-19 post vaccination. No follow-up attempts are possible; information about lot number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Seizures cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/06/2021,02/10/2021,4.0,PVT,COUMADIN,,Medical History/Concurrent Conditions: Atrial flutter,,,"['Computerised tomogram head', 'Laboratory test', 'Seizure']",UNK,PFIZER\BIONTECH, 1058148,VA,50.0,M,"Severe Tinnitus; Slight soreness at injection site on 06Feb2021; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261), via an unspecified route of administration in the left arm on 06Feb2021 at 13:45 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), and simvastatin (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took oxycodone hydrochloride/paracetamol (PERCOCET) on unknown dates for an unknown indication and experienced drug allergy. The patient experienced slight soreness at injection site on 06Feb2021 and severe tinnitus on 08Feb2021 at 05:00; both reported as serious for disability. The tinnitus was further described as intermittent and constant buzzing and vibrations in right ear only. No other issues or symptoms. The patient did not receive any treatment for the events. The clinical outcomes of the tinnitus and slight soreness at injection site were not recovered.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/06/2021,02/06/2021,0.0,PUB,LEVOTHYROXINE; LISINOPRIL; SIMVASTATIN,,,,,"['Tinnitus', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1058149,DE,62.0,F,"had been having more ear pain / had not had ear pain in awhile /right ear had been hurting her; had been having more ear pain / had not had ear pain in awhile /right ear had been hurting her; Itching on the left side of her tongue; She had a little bit of swelling on the left side of her tongue; Other autoimmune type things going on; This is a spontaneous report from a contactable nurse reporting for herself. This 62 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3246) on 19Jan2021 at 14:30 (at the age of 62 years old), in left arm, for COVID-19 immunisation. Prior vaccinations (within 4 weeks) or on the same day: none. Medical history included ongoing trigeminal neuralgia (she had nerve issues, clarifying she was diagnosed about 6-1/2 years ago with trigeminal neuralgia that caused right-sided pain in her head and in her right ear), Raynaud's in her hands and feet since she was a kid. The patient previously took a 7-day course of levofloxacin (LEVAQUIN) and after that she had a diagnosis of ongoing erythromelalgia in her hands and feet and permanent ringing in ears, both since 2014, after she took, saying she functioned fine with the permanent ringing in her ears, she had gotten used it. She also felt horrible and had a muscle tear in her right arm a week after taking Levaquin. Concomitant medication included nortriptyline 20 mg capsule once daily (at night), ongoing since about 6-1/2 years ago, for trigeminal neuralgia. On 19Jan2021, 3 hours after vaccination, the patient experienced itching on the left side of her tongue. On the same day she had a little bit of swelling on the left side of her tongue. She took 1 generic 25 mg tablet of diphenhydramine (BENADRYL) at 19:30 and was okay and slept fine. The next day it felt different but it wasn't itching. She had other autoimmune type things going on. Since an unspecified date in Feb2021 the patient had been having more ear pain and usually took medicine for this but had not had ear pain in awhile. The patient said the left side of her tongue itching and swelling was enough to make her concerned. She also said she was concerned that there may be something in the COVID-19 vaccine that will activate her nerve issue since her right ear had been hurting her since Feb2021. She said she thought that maybe the cold weather was causing her right ear pain, but she had been on medication for over 6 years now that had been taking care of her right ear pain. She said she did not want to have the second COVID-19 vaccine injection if it was going to set off her nerve issue. She stated the doctors were thinking that she should get it but staying there and be monitored and not get it on her day off. She would be getting it at the student health center where she worked so she could be monitored and would have access to medical treatment if needed. Relevant tests: none. The events did not require ER visit or physician office visit. Itching on the left side of her tongue resolved on 19Feb2021. Swelling of tongue resolved on 20Feb2021. The other events outcome was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of autoimmune disorder and other events due to temporal relationship. However, the reported events may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including autoimmune panel, ANA and ESR, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,SCH,NORTRIPTYLINE,"Trigeminal neuralgia (diagnosed about 6-1/2 years ago, caused right-sided pain in her head and in her right ear)",Medical History/Concurrent Conditions: Ear pain; Head pain; Raynauds (Raynaud's in her hands and feet since she was a kid),,,"['Autoimmune disorder', 'Disease recurrence', 'Ear pain', 'Swollen tongue', 'Tongue pruritus']",1,PFIZER\BIONTECH, 1058150,OH,39.0,F,"convulsing uncontrollably; stroke; rash; chest felt really heavy like someone was sitting on it; her throat felt like it was on fire; shaking uncontrollably/ arms and legs were shaking; Her speech was slurred, she could not communicate; Stuttering; dysphagia; tongue was falling to the side/mile was droopy on the right side/right arm- she would try to move it but it would not go/right leg was almost paralyzed; This is a spontaneous report from a contactable consumer (patient herself). A 39-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 09Feb2021 18:10 at a single dose for COVID-19 immunization. The patient had no relevant medical history. She was healthy and takes no medications. The patient got the vaccine Tuesday night at 6:10 PM. She waited in the parking lot where she got it, which was through (School Name). She had a severe reaction and had to receive an Epi Pen. This reaction occurred maybe 10 minutes after she got it. She had not left the parking lot yet, so it was prior to the 15 minutes. She broke out in a rash, her chest felt really heavy like someone was sitting on it, like an elephant, and her throat felt like it was on fire which is what is started as, then it went to her ears. From there, it escalated. She had gotten out of her car and took her sweatshirt off, she thought she was just hot. As soon as she got back in the car and as soon as she got in she started convulsing uncontrollably and shaking uncontrollably. Two ladies she works with had parked next two her on both sides and they noticed this and went to get the emergency squad. She did not lose consciousness. She could still hear everything but her arms and legs were shaking, and her right leg was shaking and stuck. The emergency squad had to help her out of the car. The ambulance gave her an Epi Pen injection and the squad took her to the hospital. Her speech was slurred, she could not communicate. She was stuttering the same thing over and over. She had a CAT scan with contrast and the stroke team decided she needed TPA - the stoke medication. They administered that and admitted her to the hospital Tuesday night. Wednesday she had an MRI, echocardiogram and another CAT scan and they released her to come home last night. She is still having lingering effects. Her speech is back. Her arm movement is back. The reason they treated her as a stroke patient, they said, is because when they told her to stick her tongue out, she had dysphagia - her tongue was falling to the side, and her smile was droopy on the right side. Her right arm- she would try to move it but it would not go. And her right leg too. She could do everything on her left side and nothing on her right side. She was conscious and could hear but could not get anything to work. After receiving the TPA, Wednesday when she woke up, she was being checked on every 30 minutes throughout the night, she was able to speak and communicate. She will still stutter and have slow words but it is way better and she can communicate. Her right arm is able to move and she can use it but her fine motor is hard. Like writing stuff is a challenge. She also has a walker. Her right leg is almost paralyzed, it drags beside her as she walks. She can move but has to really concentrate to get going. She has not reached out to her doctor yet. She was admitted to the hospital and had a bunch of tests done. The Epi Pen gave her stroke like symptoms. They were not sure in the hospital if it was actually a stroke based on her 2 MRI's and CAT scans. It did not look like a stroke from those but they think that the Epi Pen and the stress it puts into your body made her body shut down. Which the Epi Pen they said can cause stroke like symptoms. They were unsure as they have seen multiple things with the vaccine come in over the last few weeks. They told her she would need to work on the therapies out-patient. She will have to have PT/OT for lingering effects she was suffering from. Outcome of events was recovered with sequelae.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/09/2021,02/09/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Cerebrovascular accident', 'Chest discomfort', 'Computerised tomogram', 'Dysarthria', 'Dysphagia', 'Dysphemia', 'Echocardiogram', 'Hemiplegia', 'Magnetic resonance imaging', 'Rash', 'Seizure', 'Throat irritation', 'Tremor']",1,PFIZER\BIONTECH, 1058151,,,F,"thrombocytopenia; This is a spontaneous report from a non-contactable consumer (the patient daughter). A non-pregnant elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient diagnosed with COVID-19. It is unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On an unspecified date the patient experienced thrombocytopenia. The patient had lab tests and procedures performed which included platelet count: thrombocytopenia on an unknown date. It was unknown if treatment was received for the event. The clinical outcome of thrombocytopenia was not recovered. If was unknown if since the vaccination, the patient had been tested for COVID-19. Information on the lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Platelet count', 'Thrombocytopenia']",UNK,PFIZER\BIONTECH, 1058152,,,F,"stroke; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, Lot unknown, first dose) intramuscular on 01Feb2021 (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 05Feb2021, four days after vaccination, the patient had a stroke. The outcome of the event stroke was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/05/2021,4.0,UNK,,,,,,['Cerebrovascular accident'],1,PFIZER\BIONTECH,OT 1058153,TX,76.0,M,"Bell's Palsy - L facial droop; This is a spontaneous report from a contactable physician. A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK4176), intramuscularly on 22Jan2021 at 08:00 am on the left arm at single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM 2), hypertension (HTN), hypersensitivity lung disease (HLD), and hepatitis C (Hep C) s/p treatment, all from an unknown date. Patient had no known allergies. Concomitant medication included acetylsalicylic acid (ASA), gabapentin, lisinopril, and an unspecified statin from unknown dates and indication. No other vaccines were received in four weeks. On 27Jan2021, it was reported that the patent experienced Bell's palsy - L facial droop which resulted in emergency room visit and required treatment of ""Pred"". The patient had no COVID prior to vaccination and was tested post vaccination on 27Jan2021 via nasal swab which had a negative result. The patient received the vaccine in a hospital. The outcome of the event was reported as recovering.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of event Bell's palsy cannot be excluded, due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/27/2021,5.0,PVT,ASA; GABAPENTIN; LISINOPRIL,,Medical History/Concurrent Conditions: Hepatitis C (s/p treatment); Hypertension; Pulmonary sensitisation; Type 2 diabetes mellitus,,,"['Facial paralysis', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1058154,AK,44.0,F,"I woke up severely dizzy; I couldn't walk; vomiting; tongue swelled; having an allergic reaction to the Covid vaccine; coughing up mucus; severe body aches; This is a spontaneous report from a contactable consumer (patient). Information were received also from Pfizer-sponsored program COVAX US Support. A 44-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#EL9267), via an unspecified route of administration in the left arm on 09Feb2021 17:30 at single dose for COVID-19 immunisation. Medical history included asthma, iodine allergy. The patient previously took atropine and sulfur and experienced drug hypersensitivity. The patient was not pregnant. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast (MONTELUKAST), ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTI VIT), colecalciferol (VITAMIN D). The patient experienced dizziness, couldn't walk, vomiting, tongue swelled, allergic reaction to the covid vaccine, coughing up mucus and severe body aches on 10Feb2021 at 00:00 with outcome of recovering. The patient reported that about six hours after the vaccine, she woke up severely dizzy, she couldn't walk and was vomiting. Her husband called the paramedics and She was taken to the hospital. She was at the hospital for 6 hours. Her tongue swelled while she was at the hospital (as reported). The attending physician said that she was having an allergic reaction to the Covid vaccine. She was not been able to go to work this week. She had been coughing up mucus and had had severe body aches. The patient would like to have help paying for the medical bills she had incurred. Events resulted in Emergency room/department or urgent care. The patient received medications as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/09/2021,02/10/2021,1.0,PUB,ADVAIR; MONTELUKAST; MULTI VIT; VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: Asthma; Iodine allergy,,,"['Dizziness', 'Gait disturbance', 'Hypersensitivity', 'Pain', 'Productive cough', 'Swollen tongue', 'Vomiting']",1,PFIZER\BIONTECH, 1058159,AZ,84.0,F,"left side of face drooping, could not smile, could not close left eye; feeling numbness/tingling lower lip; feeling numbness/tingling lower lip; This is a spontaneous report from a contactable consumer reporting for herself. A 84-years-old female patient received the second dose of bnt162b2 (BNT162B2;Lot # EL9269) vaccine , via an unspecified route of administration in the left arm on 08Feb2021 19:30 at single dose for covid-19 immunisation . Medical history included atrial fibrillation, allergy to sulpha. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 on 15Jan2021. The patient experienced left side of face drooping, could not smile, could not close left eye on 09Feb2021 12:00 with outcome of recovering , feeling numbness/tingling lower lip on 09Feb2021 12:00 with outcome of recovering. Therapeutic measures included: Prednisone, Valacyclovir Follow up information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/09/2021,1.0,PUB,,,Medical History/Concurrent Conditions: AFib; Sulfonamide allergy (known allergies: sulpha),,,"['Facial paralysis', 'Hypoaesthesia oral', 'Paraesthesia oral']",2,PFIZER\BIONTECH, 1058160,NE,97.0,M,Resident expired on 2-25-21,Yes,02/25/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/25/2021,14.0,OTH,"Acetaminophen, Aspirin, Atorvastatin, Carvedilol, Fiber-lax, Furosemide, Levetiraceta, Levothyroxin, Lorazepam, Quitiapine, Terazosin, VitD, Antidiarrheal tabs PRN,Tramadol PRN",None,"Hypertension, Hypothyroidism, Hyperlipidemia, seizures, Dementia, Edema Legs",,NKDA,['Death'],2,MODERNA,IM 1058169,OH,65.0,F,"Diagnosed with May-thurner syndrome; Deep vein thrombosis; Both of her feet were only slightly swollen; Dull minor headache; Off-label use; Inappropriate schedule of vaccine administered; Localized discomfort where injection of second dose of Pfizer COVID-19 Vaccine was given; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (weight: 77.56 kg, height: 157 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the upper left arm, on 23Jan2021, for COVID-19 immunisation. Relevant medical history included thyroid condition from an unspecified date (over 25-30 years before this report) and ongoing, controlled with levothyroxine sodium (SYNTHROID); and breast cancer from an unspecified date, in 2019 (treatment and surgery on an unspecified date, in 2019. Presumed resolved with radiation treatment, but no treatment within a year prior to getting Pfizer COVID-19 vaccine). The patient previously, on 05Jan2021 (18 days before the second dose), received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) for COVID-19 immunisation. After the first dose, the patient experienced localized discomfort at the injection site and swelling of feet. Concomitant medication included levothyroxine sodium (SYNTHROID) from an unspecified date and ongoing, 0.88 mg, daily, for thyroid condition. On 23Jan2021, the patient experienced injection site discomfort described as ""localized discomfort where injection of second dose of Pfizer COVID-19 Vaccine was given"". On 24Jan2021, she had dull minor headache. On an unspecified date, the patient was hospitalized after the second dose and was diagnosed with May-thurner syndrome. She clarified that May-Thurner syndrome was where the iliac artery collapses and crushed the iliac vein in the upper abdomen; from that point down it started creating a blood clot. She developed a deep vein thrombosis (DVT) from her left ankle up to her right rib cage area; it was a monster. On 10Feb2021, the patient experienced deep vein thrombosis and thrombectomy was performed on the same day (outpatient thrombectomy surgery, performed 10Feb2021. It was a great surgery, very corrective. She never did have any pain or discomfort which confused everyone. She felt fine this whole time, no issues). On an unspecified date, both of her feet were only slightly swollen. Relevant laboratory test, performed on an unspecified date, in 2021, included computerised tomogram (CT scan with contrast of her abdomen and chest) that showed deep vein thrombosis: left ankle-right ribcage area. The adverse events May-Thurner syndrome and deep vein thrombosis were assessed as serious, hospitalization required from 02Feb2021 to 10Feb2021. The patient recovered from deep vein thrombosis on 10Feb2021, recovered from headache on 26Jan2021, recovered from swelling of feet and vaccination site discomfort on an unspecified date, while clinical outcome of the other events was unknown. Her vascular surgeon said he did not believe these events were vaccine related but cannot rule it out; her Primary Care Physician absolutely believed the events were vaccine related. The information on the lot number has been requested.",Not Reported,,Not Reported,Yes,8.0,Not Reported,Y,01/23/2021,01/23/2021,0.0,MIL,SYNTHROID,Thyroid disorder (controlled with levothyroxine sodium (SYNTHROID)),Medical History/Concurrent Conditions: Breast cancer,,,"['Computerised tomogram', 'Deep vein thrombosis', 'Headache', 'Inappropriate schedule of product administration', 'May-Thurner syndrome', 'Off label use', 'Peripheral swelling', 'Vaccination site discomfort']",2,PFIZER\BIONTECH, 1058171,IN,89.0,M,Death,Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,02/07/2021,16.0,PVT,,,"Pacemaker, high blood pressure, kidney disease, dementia",,,['Death'],1,PFIZER\BIONTECH,IM 1058182,FL,69.0,F,"3 days after vaccine started coughing up blood clots. Started off as a couple small clots then within a half hour later I coughed up the size of a quarter Went to ER and then was admitted.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9269), intramuscular at the right arm on 05Feb2021 13:30 at single dose for COVID-19 immunization. The patient's medical history included rheumatoid arthritis (RA), transient ischaemic attack (TIA), atrial fibrillation (AFib), thyroid nodules, and back surgery. The patient's concomitant medications included methotrexate, atorvastatin, rivaroxaban (XARELTO), ergocalciferol (VIT D), and zinc. The patient was not pregnant at the time of vaccination. The patient previously took sulfur and acetylsalicylic acid;oxycodone hydrochloride (PERCODAN). The patient previously received the first dose of BNT162B2 (lot number: EL8982) on 15Jan2021, 01:30 PM at left arm for COVID-19 immunization. On 08Feb2021 23:45, 3 days after vaccine started, patient experienced coughing up blood clots. It started off as a couple small clots then within a half hour later, she coughed up the size of a quarter. She went to the emergency room (ER) and then was admitted for 3 days. The patient underwent lab tests and procedures which included nasal swab: negative on 09Feb2021. The patient had Cat Scans and broncoscopy as treatment for the event. Facility were the most recent COVID-19 vaccine was administered was reported as other. The outcome of the event was recovered on Feb2021.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/05/2021,02/08/2021,3.0,UNK,METHOTREXATE; ATORVASTATIN; XARELTO; VIT D; ZINC,,Medical History/Concurrent Conditions: AFib; Back surgery; RA; Thyroid nodule; TIA,,,"['COVID-19', 'Haemoptysis']",2,PFIZER\BIONTECH,OT 1058188,KY,77.0,F,"Lost hearing in my right ear; This is a spontaneous report from a contactable consumer, the patient. A 77-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration from in the left arm on 23Jan2021 at 15:00 (at the age of 77-years-old) as a single dose, for COVID-19 vaccination The patient medical history and concomitant medications were not reported. The patient had no known allergies. On 12Feb2021 at 18:00, The patient experienced lost hearing in my right ear (medically significant). No treatment was given for the event. The clinical outcome of the event lost hearing in right ear was not recovered. Information on Lot number was requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,02/12/2021,20.0,UNK,,,,,,['Deafness'],1,PFIZER\BIONTECH, 1058190,DE,71.0,F,"On the evening of 2/23/221 at 9:00 pm, resident reported feeling SOB, BP 80/44, Pulse 53, O2Sat 95% on 3L oxygen, hands cold, pulse weak. Temp 92.5F MD notified. EMS activated. EMS arrival and HR 20. Family refused transport to ER. Resident expired at 2:40 am on 2/24/21 Meds continued: duloextine, VITd2,hydralazine, synthroid, lisinopril, mag ox, folplex, pantoprazole, potassium chloride, ellipta, ensure, hydrocortisone cream, boost, deprox, xanax, morphine, lorazepam, tylenol, albuterol inhlation, ventolin inh.",Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/23/2021,1.0,SEN,"atenolol, atorvastatin, budesonide-formoterol, diltiazem","acute polynephritis, acute kidney failure","HTN, hypothyroidism, afib, COPD, alopecia,anxiety disorder, depression, GERD, hyperlipidemia",,"pcn, doxycycline","['Body temperature decreased', 'Death', 'Dyspnoea', 'Peripheral coldness', 'Pulse abnormal']",1,PFIZER\BIONTECH,IM 1058192,NE,90.0,M,"2/24/21 Patient Died. 02/23/21. Patient came to ED for weakness/falls. Patient had fallen on 02/21 and 02/23. UA was done in LTC, and he was started on ciprofloxacin 02/22/21. Treatment was to put patient on comfort cares (morphine + lorazepam)",Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/24/2021,6.0,PVT,"Xanax, Vitamin d2, levothyroxine, Tylenol, ciprofloxacin, doxazosin, furosemide, Duo-Neb, melatonin metoprolol, pantoprazole, artificial tears, potassium chloride.","UTI on 02/21. 02/23 ED visit: AKI, HTN, Fall/weakness, NSTEMI, sepsis with hypoxic resp. failure.","Obstructive bladder, GERD, HTN, Hypothyroidism, Malignant neoplasm of prostate, hyperlipidemia, Type 2 DM, Vit D deficiency, osteoarthritis, peripheral edema, Diabetic neuropathy.",,etodolac. reaction unknown.,"['Acute myocardial infarction', 'Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Asthenia', 'Blood creatinine increased', 'Blood lactic acid increased', 'Blood potassium increased', 'Blood urea increased', 'Death', 'Electrocardiogram abnormal', 'Fall', 'Procalcitonin increased', 'SARS-CoV-2 test negative', 'Troponin normal', 'Urine analysis']",2,PFIZER\BIONTECH,IM 1058196,FL,75.0,F,"absolute neutropenia, relative lymphocytosis, normocytic anemia and a typical monocular cells; Increasing fatigue and shortness of breath; Increasing fatigue and shortness of breath; absolute neutropenia, relative lymphocytosis, normocytic anemia and a typical monocular cells; absolute neutropenia, relative lymphocytosis, normocytic anemia and a typical monocular cells; This is a spontaneous report from a health care professional, the patient. A 75-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration from in the right arm on 29Jan2021 at 13:30 (at the age of 75-years-old) as a single dose, for COVID-19 vaccination. Medical history included heart valve replacement (under the care of cardiologist for heart valve leakage causing some shortness of breath & fatigue, but was manageable), thyroid cancer, breast cancer female and tricuspid valve disease. Patient did receive concomitant medications in two weeks but details were not provided. The patient previously took penicilin and experienced drug hypersensitivity.. No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. On 01Feb2021 at 12:00, The patient experienced absolute neutropenia (medically significant) and relative lymphocytosis, normocytic anemia and a typical monocular cells, and increasing fatigue and shortness of breath (in 2 weeks since vaccine on 29Jan2021; almost debilitating). The patient underwent lab tests included Blood test 4 months earlier results were normal on an unspecified date, Blood Test during routine check-up on 02Jan2021, revealed absolute neutropenia, relative lymphocytosis, normocytic anemia and a typical monocular cells. . No treatment was given for the events. Consumer inquired if the vaccine can contribute to increase in fatigue and shortness of breath and new blood work reading. The clinical outcome of the events absolute neutropenia, lymphocytosis, normocytic anemia and a typical monocular cells, and increasing fatigue and shortness of breath was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/01/2021,3.0,UNK,,,"Medical History/Concurrent Conditions: Breast cancer female; Heart valve replacement (Under care of cardiologist for heart valve leakage causing some SOB & fatigue, but was manageable); Thyroid cancer; Tricuspid valve disorders, specified as non-rheumatic",,,"['Blood test', 'Dyspnoea', 'Fatigue', 'Lymphocytosis', 'Neutropenia', 'Normocytic anaemia']",1,PFIZER\BIONTECH, 1058203,OH,89.0,F,"right arm is sore; Fever; tired; This is a spontaneous report from a contactable Nurse (patient). An 89-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/lot # EM9809, Exp date 30Jun2021) intramuscular at single dose in right upper arm on 11Feb2021 16:24 for Covid-19 immunisation, administered at hospital. Medical history included ongoing chronic obstructive pulmonary disease (COPD) and ongoing arthritis both diagnosed about 5 or 6 years before, covid-19 and pneumonia in Nov2020 and she was in the hospital from 04Nov2020 to 09Nov2020, she was hard of hearing. There were no concomitant medications. The patient received no prior vaccinations (within 4 weeks), aside the 1st dose of bnt162b2 (BNT162B2, Lot: EL9261, Exp date 31May2021) intramuscular at single dose in right upper arm on 21Jan2021 16:24 for Covid-19 immunisation. No additional vaccines administered on same date of BNT162B2. No events occurred following prior vaccinations. The patient experienced right arm is sore, fever, tired on 12Feb2021. The events were considered medically significant. No event required a visit to Emergency Room or physician. No relevant test done. Course of events as follows: Her arm was sore. Sore arm started on 12Feb2021 morning. She has arthritis and stated maybe this had something to with the soreness in upper right arm, near shoulder, where the vaccine was administered about an inch below her shoulder. Soreness was just there, it hurt. She was very tired and running a temperature of 100.4. She noticed the fever when she got up on 12Feb2021 morning, it was only 99.3 or 99 something, in afternoon it was 100.4. She did not like the fever. She took of paracetamol (TYLENOL 500mg, Lot: 9HV1619, Expiration date May2021) 1000mg twice and it did not really take her fever down. The outcome of events was not recovered. The reporter considered there was a reasonable possibility that the events right arm is sore, fever, tired were related to the BNT162B2.; Sender's Comments: Based on information available, a acausal relationship between events right arm is sore, fever and tiredness and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/12/2021,1.0,PVT,,"Arthritis (Diagnosed about 5 or 6 years ago); COPD (Diagnosed many years before, about 10-15 or more years before)",Medical History/Concurrent Conditions: COVID-19 (She had covid and pneumonia in Nov2020. She was in the hospital from 04Nov2020 to 09Nov2020.); Hearing reduced; Hospitalization (She was in the hospital from 04Nov2020 to 09Nov2020.); Pneumonia (She had covid and pneumonia in Nov2020. She was in the hospital from 04Nov2020 to 09Nov2020.),,,"['Body temperature', 'Fatigue', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH,OT 1058214,NC,84.0,F,"The day following Moderna #2 (on 2/17/21) she had sudden onset of confusion. She thought the remote control was the telephone and speech was confused. No motor deficits. Was taken to ER and then admitted to Medical Center for stroke-like symptoms. Admitted 2/18/21, discharged 2/20/21 with diagnosis of Acute Encephalopathy (possible TIA) and Accelerated hypertension.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/17/2021,02/18/2021,1.0,PVT,"Losartan 25mg Levothyroxine 112mcg Pantoprazole 40mg Polyethylene Glycol 3350 PRN Fluticasone Propionate 50mcg nasal spray Vitamin D3 2,000 iu ASA 81mg Vitamin B12 1000mcg","""Chest congestion"" 2/8/21 - but normal vitals, normal pulse ox, and normal chest xray. Saw GI & Thought to be secondary to post-nasal drainage.",1. Hypertension (I10) 2. Hyperlipidemia (E78.5) 3. Hypothyroidism (E03.9) 4. Vitamin D deficiency (E55.9) 5. Osteopenia (M85.80) 6. Gastritis (K29.70) 7. Hashimoto's thyroiditis (E06.3) 8. Hyponatremia (E87.1),,Lisinopril Macrobid,"['Accelerated hypertension', 'Atelectasis', 'Blood sodium normal', 'Blood thyroid stimulating hormone normal', 'Chest X-ray normal', 'Computerised tomogram head', 'Confusional state', 'Differential white blood cell count normal', 'Encephalopathy', 'Hypokalaemia', 'Magnetic resonance imaging brain abnormal', 'Neurological symptom', 'SARS-CoV-2 test negative', 'Speech disorder', 'Ultrasound Doppler', 'Urine analysis normal', 'White blood cell count normal']",UNK,MODERNA,IM 1058215,IL,77.0,F,"Shortness of breath and respiratory distress resulting in mechanical ventilation. Some concern for myasthenia crisis due to presentation, started on course of IVIG. Possible azithromycin (home medication) could have been contributing to this as well. Also in septic shock with extensive lung infiltrates started on broad spectrum antibiotics with vancomycin and Zosyn - Zosyn was transitioned to cefepime. Lactic acidosis secondary to shock (initially 7.2 which has trended down to 2.5 at time of submission).",Not Reported,,Not Reported,Yes,,Not Reported,N,02/24/2021,02/25/2021,1.0,PUB,Albuterol inhaler prn; atorvastatin 40mg daily; Azithromycin 500mg PO three times weekly; Symbicort 80-4.5mcg/act 2 puffs BID; calcium carbonate-Vit D3 600-400 units 1 tablet BID; Plavix 75mg po daily; Docusate 100mg po daily; Eliquis 2.5mg,,"Myasthenia Gravis, chronic anemia; type 2 diabetes mellitus; CAD; carotid stenosis; hypertension; PAD; hypothyroidism; anxiety; COPD; OSA; chronic pain",,,"['Blood lactic acid increased', 'Dyspnoea', 'Immunoglobulin therapy', 'Lactic acidosis', 'Lung infiltration', 'Mechanical ventilation', 'Myasthenia gravis crisis', 'Respiratory distress', 'Septic shock']",2,MODERNA,IM 1058221,KY,81.0,M,"1st dose vaccine 2/21/21; developed weakness and went to ED via EMS on 2/26/21 and admitted to Hospital from ED DX: Acute respiratory failure with hypoxia ; Pleural effusion, left; Community acquired pneumonia of right lung, unspecified part of lung currently admitted to hospital during time of this report.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/21/2021,02/24/2021,3.0,PVT,,,DM; HTN; Pancreatitis; Kidney stone; COPD; GERD; Anemia,,NKA,"['Acute respiratory failure', 'Asthenia', 'Hypoxia', 'Pleural effusion', 'Pneumonia']",1,PFIZER\BIONTECH,IM 1058239,MN,49.0,F,"Received COVID vaccine 1 on 1/13 and COVID vaccine #2 2/1. 49 y/o previously healthy female who had a COVID 19 exposure ~ 1/3. The person she was exposed to tested positive 1/6 (daughter had a fever and cough). On 1/11 the patient received the 1st dose of the Pfizer vaccine. 12-24 hours after the Pfizer vaccine she developed fevers, malaise, myalgias that lasted 2-3 days (Called off work). She then returned to a normal state of health. On 2/1 she received the second dose of the vaccine. On 2/6 she developed right pleuritic chest pain so went to an urgent care. COVID 19 PCR was positive and CXR unremarkable. She was told to take naproxen and her pleuritic chest pain slowly improved. On 2/8 she started to have general malaise followed by nausea. On 2/11 she developed increased nausea and vomiting followed by diarrhea-eventually that day she had a near syncopal episode prompting her presentation to the hospital. Seen at an outside hospital between 2/11-2/12. CT abd/pelvis showed patchy ground glass opacities at the base of the lungs and she was noted to have diffuse mural thickening. There was concern for possible cholecystitis so a perc cholecystostomy tube was placed. Ultimately she developed significant hypoxic respiratory failure and had to be intubated.She was transferred to another hospital on 2/12. Initially she was started on treatment with dexamethasone but continued to clinically get worse. Also on empiric antibiotics.",Not Reported,,Not Reported,Yes,15.0,Not Reported,U,02/01/2021,02/06/2021,5.0,OTH,COVID vaccine #1 on 1/13/21 and COVID vaccine #2 2/1/21 Naproxen started 2/6/21-prn medication for chest pain,"49 y/o previously healthy female who had a COVID 19 exposure ~ 1/3. The person she was exposed to tested positive 1/6 (daughter had a fever and cough). On 1/13 the patient received the 1st dose of the Pfizer vaccine. 12-24 hours after the Pfizer vaccine she developed fevers, malaise, myalgias that lasted 3 days (Called off work). She then returned to a normal state of health. On 2/1 she received the second dose of the vaccine. On 2/6 she developed right pleuritic chest pain so went to an urgent care. COVID 19 PCR was positive and CXR unremarkable. She was told to take naproxen and her pleuritic chest pain slowly improved. On 2/8 she started to have general malaise followed by nausea. On 2/11 she developed increased nausea and vomiting followed by diarrhea-eventually that day she had a near syncopal episode prompting her presentation to the hospital.",None,,None,"['Alanine aminotransferase decreased', 'Aspartate aminotransferase decreased', 'Blood creatine phosphokinase', 'Blood lactate dehydrogenase increased', 'Cholecystectomy', 'Computerised tomogram abnormal', 'Condition aggravated', 'Diarrhoea', 'Ejection fraction decreased', 'Endotracheal intubation', 'Inflammatory marker increased', 'Liver function test abnormal', 'Lung opacity', 'Malaise', 'Myalgia', 'Nausea', 'Platelet count decreased', 'Pleuritic pain', 'Procalcitonin', 'Procalcitonin increased', 'Pyrexia', 'Respiratory failure', 'SARS-CoV-2 test negative', 'Serum ferritin increased', 'Syncope', 'Thrombocytopenia', 'Troponin I increased', 'Vomiting', 'White blood cell count decreased']",2,PFIZER\BIONTECH,IM 1058240,SC,27.0,F,"Nausea and vomiting as well as cramping that lead to being unable to eat for a week. After a week passed, was admitted to hospital for dehydration and to make sure GI problems were nothing more serious",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,01/15/2021,01/16/2021,1.0,WRK,"Yazmin, Prosac, Pantoprazole",none,GERD Functional Dyspepsia GAD,,none,"['Anion gap increased', 'Blood potassium decreased', 'Dehydration', 'Feeding disorder', 'Gastritis', 'Metabolic function test', 'Muscle spasms', 'Nausea', 'Oesophagogastroduodenoscopy abnormal', 'Vomiting']",2,PFIZER\BIONTECH,IM 1058246,LA,48.0,F,Throat Swelling / Difficulty Swallowing,Not Reported,,Yes,Not Reported,,Not Reported,N,02/26/2021,02/26/2021,0.0,OTH,Prozac Synthroid,,,,IV contrast,"['Dysphagia', 'Pharyngeal swelling']",1,MODERNA,IM 1058255,NC,56.0,M,Patient developed seizure 30 minutes after receiving injection. This was witnessed so EMS was called and taken to ED and had another seizure which was witnessed by our staff. I examined patient post ictal.,Not Reported,,Not Reported,Yes,10.0,Not Reported,Y,01/27/2021,01/27/2021,0.0,PVT,"Atorvastatin, oxycodone, oxycontin, duloxetine, gabapentin",He had just completed concurrent chemo radiation therapy for advanced non small cell lung cancer. Chemotherapy - Carboplatin and Pemetrexed last day of treatment 01/13/21,Multiple sclerosis,,"Biaxin, IV dye, morphine and sulfa drugs",['Seizure'],1,MODERNA,IM 1058266,ID,72.0,M,"Pale, not eating, no urine output",Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/24/2021,4.0,SEN,"Morphine, Haldol",Lewy-Body dementia,Lewy-Body Dementia,After 1st covid vaccine,"Carbidopa/Levodopa, penicillin, Pramipexole","['Anuria', 'Decreased appetite', 'Pallor', 'Urine output decreased']",UNK,PFIZER\BIONTECH,IM 1058325,NY,82.0,M,"Episode of confusion, fever to 104, and bilateral pulmonary infiltrates consistent with ARDS. Negative infectious diseases workup. Response to steroids. Patient was intubated due to need for supplemental FIO2 100%.",Not Reported,,Yes,Yes,13.0,Not Reported,N,02/11/2021,02/13/2021,2.0,OTH,None,None,"Hypertension, history of a Transient ischemic attack 3 years earlier",,None reported,"['Acute respiratory distress syndrome', 'Computerised tomogram thorax', 'Computerised tomogram thorax abnormal', 'Confusional state', 'Diastolic dysfunction', 'Echocardiogram', 'Echocardiogram abnormal', 'Ejection fraction normal', 'Endotracheal intubation', 'Lung infiltration', 'Oxygen therapy', 'Pulmonary hypertension', 'Pyrexia']",2,MODERNA, 1058358,WI,77.0,M,"2/24/2021 admitted to hospital with hypoxia, lethargy, rash, altered mental status with HA. Altered mental status with HA, could be due to metabolic encephalopathy and reaction to COVID-19 vaccine. Will check ABG, CT head. Hold gabapentin. Check depakote level. Rash, likely due to allergic reaction to COVID-19 vaccine, hx of reaction to first COVID-19 vaccine with fever needing hospitalization. Start patient on Solu-Medrol and Pepcid. Benadryl p.r.n. Suspected right lower extremity cellulitis, start patient on Ancef. Check MRSA, will rule out right DVT Abn CXR, Bilateral LE edema, CXR seems stable to me, clinically no pneumonia. He does not have ""hypoxia"" when I was in room, however assisted living reporte 2/24/2021 admitted to hospital with hypoxia, lethargy, rash, altered mental status with HA. Altered mental status with HA, could be due to metabolic encephalopathy and reaction to COVID-19 vaccine. Will check ABG, CT head. Hold gabapentin. Check depakote level. Rash, likely due to allergic reaction to COVID-19 vaccine, hx of reaction to first COVID-19 vaccine with fever needing hospitalization. Start patient on Solu-Medrol and Pepcid. Benadryl p.r.n. Suspected right lower extremity cellulitis, start patient on Ancef. Check MRSA, will rule out right DVT Abn CXR, Bilateral LE edema, CXR seems stable to me, clinically no pneumonia. He does not have ""hypoxia"" when I was in room, however assisted living reported he was hypoxic this AM, wife said he was wheezy on Sunday could be due to acute on chronic diastolic congestive heart failure, IV Lasix x1. reeval in AM. Echo TTE is pending Abdominal pain and distension, CT abdomen without contrast to rule out other etiology that can cause altered mental status Hx of COVID-19 pneumonia, history of CVA with dense right hemiplegia and expressive aphasia, chronic atrial fibrillation, depression, Will reorder home meds after pharmacist reconciles medication list Generalized weakness, PT/OT DVT prophylaxis warfarin and SCD",Not Reported,,Not Reported,Yes,,Not Reported,N,02/23/2021,02/24/2021,1.0,SEN,"Coumadin 3 mg PO HS, Vitamin C 1000mg PO daily, Cholecalciferol 125mcg PO daily, Lasix 10 mg PO daily, Protonix 40mg PO HS, Zincate 220(50Zn) one tablet PO daily, Pramoxine (Sarna Sensitive) 1% lotion apply topically 2 times daily after usi",COVID positive 12/30/2020,"CVA (cerebral vascular accident) (CMS/HCC) o Hyperbilirubinemia o Benign prostatic hyperplasia without lower urinary t CVA (cerebral vascular accident) (CMS/HCC) o Hyperbilirubinemia o Benign prostatic hyperplasia without lower urinary tract symptoms o Hemiplegia affecting dominant side, post-stroke (CMS/HCC) o Personal history of PE (pulmonary embolism) o Calculus of proximal right ureter",COVID19 (Moderna) on 1/26/2021,No known allergies,"['Abdominal distension', 'Aortic valve incompetence', 'Atrial enlargement', 'Back pain', 'Blood folate', 'Brain natriuretic peptide increased', 'Cardiac failure acute', 'Cardiac failure congestive', 'Cellulitis', 'Chest X-ray abnormal', 'Chest X-ray normal', 'Compression fracture', 'Computerised tomogram abdomen', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram head normal', 'Computerised tomogram pelvis abnormal', 'Dyspnoea', 'Echocardiogram abnormal', 'Ejection fraction', 'Headache', 'Hypersensitivity', 'Hypoxia', 'Lethargy', 'Lung infiltration', 'Mental status changes', 'Metabolic encephalopathy', 'Mitral valve incompetence', 'Oedema peripheral', 'Pleural effusion', 'Pyrexia', 'Rash', 'Respiratory tract congestion', 'Right ventricular systolic pressure', 'SARS-CoV-2 test negative', 'Spinal compression fracture', 'Staphylococcus test positive', 'Thrombocytopenia', 'Tricuspid valve incompetence', 'Vaccination complication', 'Vitamin B12 normal', 'Vitamin D deficiency', 'Wheezing']",2,MODERNA,IM 1058366,NC,56.0,F,"15 minutes after receiving shot, extreme fatigue, blurry vision, bp 250/200. ON the medic transport to ER, Left side weakness, loss of speech. Er evaluated for sudden onset left sided weakness, facial droop.Code stroke was called CT angiography was unremarkable and patient admitted for bp control. Bp normalized with Clonidine , neurological exam is stable. Md felt that thus was a combination adverse reaction to vaccine in combination with Wellbutrin. Discharge after 24 hours",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/14/2021,01/14/2021,0.0,PUB,"Chlorthalidone 25 mg, Losartan 100 mg, vitamin D, MVI, Potassium Chloride 10 meQ, Wellbutrin150 mg",none,Hypertension,,"Ethanol, Wasps, bees","['Angiogram cerebral normal', 'Aphasia', 'Blood pressure management', 'Chest X-ray normal', 'Computerised tomogram head normal', 'Computerised tomogram normal', 'Facial paralysis', 'Fatigue', 'Hemiparesis', 'Magnetic resonance imaging brain normal', 'Neurological examination', 'Perfusion brain scan abnormal', 'Vision blurred']",1,PFIZER\BIONTECH,IM 1058369,TX,35.0,F,"I had horrible body aches, chills, fever (100.8).It felt impossible for me to move around. I was in early stage of my pregnancy took a test on 1/7. My first doctor appt was 2/1 was told 8 weeks pregnant had a ultrasound didn't show any yoke or fetus. I had multiple ultrasounds done that week to enI had to have a DNC on 2/10 done and I'm still waiting on my DNA chromosomes to come back (plasenta show abnormality).(estimated date of delivery Pt stated around Sept 2021)",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/05/2021,01/06/2021,1.0,PVT,Zyrtec (per diem),No,No,,Penicillin,"['Blood test', 'Chills', 'Chromosomal analysis', 'Exposure during pregnancy', 'Mobility decreased', 'Pain', 'Placental disorder', 'Pregnancy', 'Pyrexia', 'Ultrasound antenatal screen abnormal', 'Uterine dilation and curettage']",2,PFIZER\BIONTECH,IM 1058379,KY,79.0,M,"1st dose vaccine 2/23/21; EMS called after pt fell at home 2/25/21; taken to ED and admitted to hospital DX: 1. Right-sided nontraumatic intracerebral hemorrhage, unspecified cerebral location (CMS/HCC) I61.9 431 2. Long term (current) use of anticoagulants Z79.01 V58.61 3. Sensory neglect (left sided) R41.4 781.8 currently still admitted to hospital at the time of this report",Not Reported,,Not Reported,Yes,,Not Reported,U,02/23/2021,02/25/2021,2.0,PVT,,Multiple; see chart,,,Motrin,"['Cerebral haemorrhage', 'Fall', 'Neurologic neglect syndrome', 'Sensory loss']",1,PFIZER\BIONTECH,IM 1058431,NY,40.0,F,"Patient noted onset of diffuse abdominal pain on 2/25/21. This was accompanied with urgency with loose stools. Subsequently, the patient had persistent vomiting throughout the night. She denies fevers or chills. She has never had similar symptoms in the past. She reports that the abdominal pain localized to the right lower quadrant.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/24/2021,02/25/2021,1.0,PVT,"Cholecalciferol, Vitamin D3, (VITAMIN D3) 2,000 unit cap capsule Take 2,000 Units by mouth daily. Cyanocobalamin (VITAMIN B-12) 1,000 mcg tablet Take 1 Tab by mouth daily.",None,B12 deficiency Herniated lumbar intervertebral disc L4-L5 Vitamin D deficiency,,Aspirin (nausea),"['Abdominal pain', 'Abdominal pain lower', 'Appendicitis', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram pelvis abnormal', 'Diarrhoea', 'Vomiting']",1,PFIZER\BIONTECH,IM 1058447,PA,47.0,M,"Moderna COVID- 19 Vaccine EUA Patient was found deceased in the community near his home address on 2/24/21. The Medical Examiner's cause of death is currently listed as ""Drug Intoxication - Accidental Overdose."" Per the MEO, post mortem urine toxicology was positive for cocaine and fentanyl. His death is believed to be related to a cocaine product that was adulterated with fentanyl and is not believed to be related in any way to the Moderna COVID-19 vaccine. This was explicitly stated by the Medical Examiner's Office.",Yes,,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/24/2021,1.0,UNK,"Albuterol, abilify, mirtazapine, buprenorphine/naloxone,",None known,"Opioid use disorder, cocaine use disorder, hypertension, asthma, hepatitis C (treated), tobacco use, bipolar",,Lamotrigine,"['Accidental overdose', 'Death', 'Drug abuse', 'Drug screen positive', 'Toxicity to various agents', 'Urine analysis abnormal']",1,MODERNA,IM 1058476,MA,21.0,F,"Day of vaccine, 4hrs post vaccine: felt drunk/high/intoxicated (touch was intensified, numbing feeling) Day 2-3: exhausted and fever of 102F, body aches, chills, nausea Day 4: started feeling better, fever went down with Tylenol Day 5 3am: woke up with chest pain (3.5-4/10), went away with Tums; 0930pm chest pain 6/10 while sitting at desk, increased to 7/10, lasting 2 hours by the time I went to the ER",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/07/2021,02/07/2021,0.0,PHM,Birth Control Pill (with estrogen) Melatonin Women's multivitamin gummy,None,Undiagnosed Autoimmune Disorder,,None,"['Autoimmune disorder', 'Blood creatine phosphokinase increased', 'C-reactive protein increased', 'Chest X-ray normal', 'Chest pain', 'Chills', 'Computerised tomogram normal', 'Condition aggravated', 'Electrocardiogram abnormal', 'Euphoric mood', 'Fatigue', 'Feeling drunk', 'Fibrin D dimer increased', 'Hyperaesthesia', 'Hypoaesthesia', 'Myocarditis', 'Nausea', 'Pain', 'Pyrexia', 'Sensory disturbance', 'Troponin increased']",2,PFIZER\BIONTECH,IM 1058477,OR,88.0,F,"Delirium, started 2-1/2 hours after injection, admitted to the hospital, required IV sedation, Then, 20 hours after vaccine developed fever up to 100.9, and patient developed somnolence but no longer combative, then about 32 hours after vaccine improved to 50% of normal status, 48 hours after vaccine was 90% normal, and then slowly returned to normal over the next 2 weeks",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/09/2021,02/09/2021,0.0,PVT,"Metoprolol, Nexium, pravastatin, calcium, vitamin D, naproxen",None,Cochlear implant Hypertension,,Lisinopril caused cough,"['Aggression', 'Chest X-ray normal', 'Computerised tomogram head normal', 'Delirium', 'Electrocardiogram normal', 'Laboratory test normal', 'Pyrexia', 'Sedative therapy', 'Somnolence']",1,MODERNA,IM 1058517,TX,69.0,M,Pt had syncopal episode due to atrial fibrillation with rapid ventricular rate. Admitted to hospital 5 days after vaccination. Treated with IV amiodarone. Prior to this he had history of atrial fibrillation converted to sinus rhythm via pulmonary vein ablation in 2012 - was in sinus rhythm for 8 years.,Not Reported,,Not Reported,Yes,6.0,Not Reported,U,01/27/2021,02/01/2021,5.0,PVT,Metoprolol Succinate ER 200 MG Tablet Extended Release 24 Hour 1 tablet Orally Once a day Losartan Potassium 100 MG Tablet 1 tablet Orally Once a day Vitamin D3 25 MCG (1000 UT) Capsule 1 capsule Orally Once a day Aspirin 325 MG Ta,none,"remote history of atrial fibrillation, s/p ablation in 2012; coronary artery disease, hyperlipidemia, gout, type 2 diabetes",,"zetia, shellfish","['Atrial fibrillation', 'Condition aggravated', 'Syncope']",2,MODERNA, 1058547,,87.0,M,"I recently reported that patient was admitted for covid-19, CTA positive for covid-19 pneumonia and covid-19 PCR positive, after 2 completed doses of Pfizer vaccine. I am re-reporting as we have recently realized that patient has history of CLL and hypogammaglobulinemia which may have affected the efficacy of the vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,,02/11/2021,02/23/2021,12.0,PVT,,,,,,"['Angiogram', 'COVID-19', 'COVID-19 pneumonia', 'Computerised tomogram abnormal', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1058569,AR,55.0,M,PATIENT DIED IN HIS SLEEP NIGHT AFTER ADMINISTRATION,Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,N,02/25/2021,02/25/2021,0.0,PHM,,,,,,['Death'],1,MODERNA,IM 1058579,WI,80.0,M,"Pt received first dose of Pfizer COVID-19 vaccine on 2/9/2021. Pt developed COVID symptoms and presented to hospital, tested positive 2/25/2021 via SARS-CoV-2 PCR NP. Symptoms: generalized fatigue and malaise, max temp 103, confusion with hallucinations, needed supplemental O2. Admitted on 2/25/2021.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/09/2021,02/25/2021,16.0,PVT,"alfuzosin, amlodipine, aspirin, fentanyl patch, hydrocodone-acetaminophen, losartan, metformin, pravastatin, venlafaxine",,"Vitamin B-12 deficiency, prostate cancer, postcholecystectomy syndrome, osteoarthritis, OSA, hypogonadism (male), hypertension, hyperlipidemia, ED, DM2, chronic back pain, cervical spinal stenosis, cervical myofascial pain syndrome, BPH",,"baclofen, scopolamine, lamictal, lisinopril, methadone, metoprolol, salsalate, hydrochlorothiazide","['Body temperature increased', 'COVID-19', 'Confusional state', 'Fatigue', 'Hallucination', 'Malaise', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1058590,CA,62.0,M,"Patient has had numbness and tingling both arms, weakness of legs and fatigue since 2 days after his Covid Vaccine Jan 6th. Has had 2 syncopal episodes since then. Had a syncopal episode Feb 15 and again 2/26/21",Not Reported,,Not Reported,Not Reported,,Yes,N,01/06/2021,01/08/2021,2.0,PVT,none,NONE,NONE,,NKDA,"['Computerised tomogram', 'Fatigue', 'Full blood count', 'Hypoaesthesia', 'Laboratory test', 'Muscular weakness', 'Paraesthesia', 'Syncope', 'Troponin']",UNK,MODERNA, 1058594,NY,71.0,M,"Total Kidney failure, Sepsis",Not Reported,,Yes,Yes,4.0,Not Reported,Y,01/04/2021,01/08/2021,4.0,PVT,"Morphine, Singular, Mobic, Zyrtec, Paxil, Lisinopril, Mucinex, Vitamin C, Vitamin D, Multivitamin, Aspirin 81mg, Vistaril, Colace, Simvastatin, Krill Oil, and Flonase.",None,"Arthritis, hyperlipidemia",,"Allergic to Tree Nuts, Peanuts, Fentanyl, Dilaudid, Oxycodone, Hydrocodone, Johnson and Johnson Adhesive Tape,","['Blood culture', 'Blood test', 'Chest X-ray', 'Computerised tomogram', 'Renal failure', 'SARS-CoV-2 test', 'Sepsis']",1,MODERNA,IM 1058604,TX,80.0,M,Patient was found on bathroom floor by spouse @ approximately 02:30 am (2.5 days after receiving 2nd dose of Covid-19 vaccine). He had fallen and had an obvious head injury & demonstrated altered mentation from usual baseline. Family utilized 911 to transport him to local ED. He was febrile upon arrival to ED and admitted for severe sepsis with unknown etiology. He was found to have positive SIRS criteria and elevated LA. He was admitted to hospital and received IV antibiotics for 11 days (spent 7 days as an inpatient and completed remaining infusions in home environment),Not Reported,,Not Reported,Yes,7.0,Not Reported,Y,02/01/2021,02/04/2021,3.0,PVT,"donepezil, b12, duloxetine, tramadol, multivitamin",none,"neuropathy, mild vascular dementia, OSA, normal pressure hydrocephalus, overactive bladder",,NKA,"['Beta haemolytic streptococcal infection', 'Blood culture positive', 'Blood lactic acid increased', 'CSF culture negative', 'Chest X-ray normal', 'Culture urine negative', 'Fall', 'Head injury', 'Magnetic resonance imaging brain abnormal', 'Mental status changes', 'Pyrexia', 'Respiratory viral panel', 'SARS-CoV-2 test negative', 'Sepsis', 'Streptococcus test positive', 'Systemic inflammatory response syndrome']",2,PFIZER\BIONTECH,IM 1058619,CO,76.0,F,"Pt received dose #2 Pfizer COVID vaccine 1/29/21 @ MAC vaccine clinic. Reported flu like symptoms over the next two days (fatigue, nausea, anorexia). 2/2/21 awoke with abdominal pain and distension. Presented to MHN ED 2/2/21 @ 1100 for workup and initially declined admission and went home. Was called and asked to return for admission and further workup, admitted to MHN 2/2/21 @ 1750. Fever, myalgias, headache. CT abd/pelvis ""There is mild diffuse mesenteric edema surrounding the abdominal aorta and proximal branches. Additionally, there is mild bowel wall thickening involving the stomach without discrete mass. This is nonspecific and may represent infectious versus inflammatory changes."" Per provider note ""flu-like sx over the weekend that easily coincide with the timing of the COVID Pfizer vaccine. In addition, I wonder if her CT scan findings might also be related to the vaccine."" Discharged home the next day.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/29/2021,01/30/2021,1.0,OTH,,,"CAD, afib, HTN, GERD",,"raspberries, strawberries","['Abdominal distension', 'Abdominal pain', 'Computerised tomogram', 'Computerised tomogram abdomen', 'Decreased appetite', 'Fatigue', 'Gastrointestinal oedema', 'Gastrointestinal wall thickening', 'Headache', 'Influenza like illness', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1058621,WA,44.0,F,"The day of vaccine, I felt a little tired. The next morning, I ended up have a lethargy reaction (9:00 am) - it was like I was a robot and I hd powered down. I couldn't sleep but I was sitting up and thought I was sleeping. I couldn't really talk. My co-workers were very concerned. Lasted a couple hours and I went home and I went to sleep and slept about 16 hours . I called off work the third day - I had slept so much after that night before I had a (first) gall bladder attack (in the middle of that 16 hours) it was very bad (the gall bladder attack). I had gall bladder attacks occur for the next few days. I ended up getting my gall bladder out last Friday - about a week ago. It was inflamed and full of pus. It was an emergent situation and I was hospitalized 18th and surgery on the February 19th. Lethargy eventually subsided (lasted a handful of hours) and was then fatigued with no energy for about a week .",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/27/2021,01/28/2021,1.0,PVT,"Daily: 1500mg Gabapentine, 450mg Buproprion, 200mcg Levothyroxine, 6000iu Vitamin D3, 1950mg Calcium Citrate, 50mg Nortriptyline, 2.5mg Eliquis, Fluticasone spray, 10mg THC","Experienced adverse symptoms dose 1 of Moderna vaccine -December 29- January 15th, 2021","Mild asthma, L5S1 Herniated disc Sciatic nerve root impingement, Hemiplegic Migraines, Arthritis",Moderna Dose 1 COVID 19 - 12/29/2021,"Penicillin, Amoxicillin, Sumatriptan, Butabarbital, Chlorine, Bleach","['Aphasia', 'Asthenia', 'Biliary colic', 'Blood test normal', 'Cholecystectomy', 'Cholecystitis', 'Cholecystitis infective', 'Fatigue', 'Full blood count normal', 'Gallbladder operation', 'Hypersomnia', 'Impaired work ability', 'Laboratory test normal', 'Lethargy', 'Ultrasound abdomen abnormal']",2,MODERNA,SYR 1058628,KS,54.0,M,"Patient received 2nd dose of Moderna Covid Vaccine at 1pm. At 2:30pm he started to develop chest pain and left side neck and arm pain. He was admitted to the hospital for further work-up. While in the hospital the patient had relief only from sitting up and forward. The doctor decided to transfer the patient to another facility that had specialist. At the next hospital it was determined that the patient had Viral Pericarditis, associated with the Covid Vaccine.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/22/2021,02/22/2021,0.0,PVT,Uroxatral 10mg daily Zyrtec 10mg daily,,,,Pollen,"['Chest pain', 'Echocardiogram abnormal', 'Electrocardiogram normal', 'Fibrin D dimer normal', 'Left ventricular hypertrophy', 'Neck pain', 'Pain in extremity', 'Right ventricular hypertrophy', 'Troponin normal', 'Ventricular enlargement', 'Viral pericarditis']",2,MODERNA,IM 1058673,MN,79.0,M,"Asymmetric polyarthritis involving right ankle, left wrist, left elbow, left shoulder and neck",Not Reported,,Yes,Yes,11.0,Not Reported,N,02/09/2021,02/11/2021,2.0,PVT,"Atorvastatin, Hydrochlorothiazide, Lisinopril, Cholestyramine, Hydrocodone-Acetaminophen, Omeprazole, Tamsulosin","Osteoarthritis, neck pain","Hypertension, Hypercholesterolemia, GERD, BPH",,None,"['Computerised tomogram', 'Polyarthritis', 'Synovial fluid analysis']",1,PFIZER\BIONTECH,IM 1058677,NM,31.0,F,"Sore throat and nasal congestion first week. Second week went to PCP for right ear pain. PCP saw infection on both ears but right eardrum was Ruptured. Second Vaccine on 2/3/21 and my symptoms for two days where headaches, fever, chills, body aches. 4 days later left ear had discharged, next day saw PCP ear infection worse. Given stronger antibiotics to take for 10more days. The next day 2/9/21 my ear was starting to swell, went to the ER and was admitted for severe ear infection. Was discharged from the hospital on 2/15/21 with a midline on my right arm to continue home health with the antibiotics through a syringe.",Not Reported,,Not Reported,Yes,7.0,Not Reported,N,01/06/2021,01/21/2021,15.0,PVT,Lutera birth control,None,None,,Seasonal Allergies,"['Blood test', 'Chills', 'Condition aggravated', 'Ear infection', 'Ear pain', 'Ear swelling', 'Headache', 'Laboratory test', 'Nasal congestion', 'Oropharyngeal pain', 'Otorrhoea', 'Pain', 'Pyrexia', 'Tympanic membrane perforation']",2,MODERNA,SYR 1058683,ND,20.0,F,Guillian Barre Syndrome with asystole for 20 seconds,Not Reported,,Yes,Yes,4.0,Not Reported,N,02/09/2021,02/11/2021,2.0,PVT,"Oral contraceptive pill, spironolactone",None,None,,None,"['CSF test abnormal', 'Cardiac arrest', 'Guillain-Barre syndrome']",2,PFIZER\BIONTECH,IM 1058699,MS,67.0,M,"2/26/21 @ 1150 Pt in 15min waiting area following administration of moderna 2nd dose. Approx. 5min into wait the pt wife reported something was wrong. Pt was pale, shaking, non responsive and urinated on himself during this event. Pulse was present. Within moments pt became responsive and answering questions. Ambulance arrived, preformed assessment, advised to go to hospital. Pt refused. Pt remained coherent and without complaints.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/25/2021,02/25/2021,0.0,PUB,unk,none,none,,nka,"['Blood glucose normal', 'Pallor', 'Tremor', 'Unresponsive to stimuli', 'Urinary incontinence']",2,MODERNA,IM 1058705,IL,74.0,M,vomiting,Not Reported,,Not Reported,Yes,,Not Reported,U,02/25/2021,02/26/2021,1.0,OTH,,,liver cancer active with chemotherapy,,,['Vomiting'],2,MODERNA,IM 1058733,WA,71.0,M,"On 02/09/2021, the patient received his first dose of the Pfizer COVID-19 vaccine. Two days later, the patient presented to ER at Hospital on 02/11/2021 after noticing right arm weakness, slurred speech and facial droop while in the shower at home. Patient was evaluated and determined to have an ischemic stroke, treated with tPA. Patient transferred to hospital ICU for monitoring on 02/12/2021. Patient transferred to step down care on 02/12/2021 and then was discharged home on 02/13/2021 with improvement in his right sided weakness and the ability to ambulate independantly.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/09/2021,02/11/2021,2.0,UNK,"atenolol, atorvastatin, sumatriptan","possible migraines, unknown frequency","Hypertension, hyperlipidemia, migraine",,no known allergies,"['Cardiac telemetry', 'Computerised tomogram head normal', 'Dysarthria', 'Facial paralysis', 'Hemiparesis', 'Intensive care', 'Ischaemic stroke', 'Muscular weakness', 'Plasminogen activator inhibitor', 'Sinus rhythm', 'Ultrasound Doppler']",1,PFIZER\BIONTECH,IM 1058747,NC,59.0,M,Patient experienced general weakness and unsteady gait as well as unexplained hyperammonia and hyponatremia.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/27/2021,02/25/2021,29.0,WRK,"ferrous sulfate 325 mg, hydroxyurea 1000 mg, hydroxyurea 500 mg, acetaminophen 650 mg, aspirin 81 mg, atorvastatin 5 mg, carvedilol 6.25 mg, citalopram 20 mg, divalproex ds 500 mg, docusate 100 mg, famotidine 20 mg, lorazepam 0.5 mg, mineri",None,"stroke with chronic right-sided residual weakness, coronary artery disease, hypertension, GERD, brain aneurysm s/p clipping",,iohexol,"['Ammonia increased', 'Asthenia', 'Blood sodium decreased', 'Gait disturbance', 'Hyperammonaemia', 'Hyponatraemia']",1,MODERNA,IM 1058751,PA,42.0,F,"The evening of my vaccination, I began to feel feverish, weak and achy. During the night I woke with heavy bleeding and found out the following morning I had miscarried my otherwise healthy pregnancy.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,UNK,No,None,None,,No,"['Abortion spontaneous', 'Asthenia', 'Exposure during pregnancy', 'Haemorrhage in pregnancy', 'Pain', 'Pyrexia', 'Ultrasound scan', 'Vaginal haemorrhage']",UNK,MODERNA, 1058775,MI,68.0,F,"Patient developed angioedema and rash around 8 am on 2/26/21. Rash was macular and erythematous located on the arms, torso, and legs. Angioedema involved the tongue. Patient presented to the emergency department and received epinephrine, Benadryl, methylprednisolone, and famotidine. She was admitted to the hospital overnight for observation.",Not Reported,,Yes,Yes,1.0,Not Reported,N,02/25/2021,02/26/2021,1.0,UNK,"Amitriptyline, vitamin C, vitamin D-3, Lotrisone, Flexeril, Relpax, Krill Oil/Omega 3 and 6, Claritin, Multivitamin, Corgard, artificial tears, Prilosec, Norco",,"Type 2 diabetes mellitus, chronic migraine, Crohn's disease, chronic post-traumatic headache, osteopenia, allergic rhinitis, fibromyalgia, hyperlipidemia, GERD, obesity",,"Lidocaine, Tetracycline, Tizanidine, Topiramate","['Angioedema', 'Erythema', 'Rash', 'Rash erythematous', 'Rash macular', 'Tongue oedema']",2,MODERNA,IM 1058793,OK,66.0,M,Pt had only complained of a sore arm after receiving the vaccine- pt died on 2/25/21 from what they feel was a massive heart attack- unsure if related to vaccine at all,Yes,02/25/2021,Not Reported,Not Reported,,Not Reported,N,02/24/2021,02/25/2021,1.0,PVT,unsure,diabetes- type 2 High bp,diabetes- type 2 High bp,,unsure,"['Death', 'Pain in extremity']",2,PFIZER\BIONTECH,IM 1058794,CO,79.0,F,"Pt received Pfizer Vaccine on 1/27/2021. Pt was admitted on 2/14/2021 for UTI, abdominal wound drainage (recent hernia repair). Not thought to be related to vaccine. Due to EUA of vaccine, ""inpatient hospitalization"" requires VAERS reporting.",Not Reported,,Not Reported,Yes,8.0,Not Reported,Y,01/27/2021,02/14/2021,18.0,PHM,,,,,erythromycin,"['Urinary tract infection', 'Wound drainage']",UNK,PFIZER\BIONTECH,IM 1058795,NC,91.0,F,Patient developed COVID 13 days after vaccine administration presenting with shortness of breath and generalized weakness.,Not Reported,,Not Reported,Yes,,Not Reported,,02/13/2021,02/24/2021,11.0,WRK,"acetaminophen 650 mg, amiodarone 100 mg, vitamin d3, vitamin b12, docusate 100 mg, ferrous sulfate 325 mg, furosemide 40 mg and 80 mg, memantine 10 mg, multivitamin, xtampza er 13.5 mg, pantoprazole 40 mg, potassium chloride 20 mEq, risperi",None,"Atrial fibrillation, congestive heart failure",,None,"['Asthenia', 'COVID-19', 'Dyspnoea']",UNK,MODERNA, 1058799,MT,46.0,F,"Sudden unilateral hearing loss on the left ear. Currently taking a 14 day dose of oral predisone, had one transtympanic injection of steroids, have had 2 audiograms. Plan to start hyperbaric oxygen treatments and have more injections and audiograms. No improvement to date.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/27/2021,02/17/2021,21.0,PUB,"Estradiol 0.1mg/day transdermal patch, 5000 IU vitamin D, multivitamin, biotin.",None,History of Narcolepsy,,None,"['Audiogram abnormal', 'Deafness unilateral', 'Sudden hearing loss']",1,MODERNA,IM 1058800,WI,41.0,F,"ON FEBRUARY 19,2021, PATIENT HAD A GRAND MAL SEIZURE IN THE EVENING. SHE REPORTED TO THE EMERGENCY DEPARTMENT AND THE CASE WAS DISMISSED AND SHE WAS SENT HOME. ON FEBRUARY 21, 2021, PATIENT HAD ANOTHER GRAND MAL SEIZURE AND WAS HOSPITALIZED. SHE WAS DISCHARGED ON KEPPRA 1000 MG TWICE DAILY. SHE REPORTS SHE HAS SWELLING ON THE LEFT SIDE OF HER BRAIN AND CONTINUES TO HAVE SMALLER SEIZURES WHERE SHE IS AWAKE BUT NOT RESPONSIVE.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/09/2021,02/19/2021,10.0,WRK,HUMIIRA; ADDERALL XR,NONE REPORTED,RA; ADD,,NONE REPORTED,"['Brain oedema', 'Electrocardiogram', 'Electroencephalogram', 'Generalised tonic-clonic seizure', 'Magnetic resonance imaging', 'Unresponsive to stimuli']",2,MODERNA,IM 1058814,NC,72.0,F,Patient experienced shortness of breath and bilateral extremity numbness and tingling since receipt of recent COVID vaccination.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/24/2021,02/24/2021,0.0,WRK,"acetaminophen, aspirin, furosemide 80 mg, glipizide 10 mg, insulin degludec 45 units, insulin lispro, losartan 100 mg, metoprolol 25 mg, pantoprazole 40 mg, potassium chloride 10 mEq, sotalol 80 mg",,"T2DM, HTN ,CAD, CVA with residual L sided hemiparesis and hearing deficit and atrial fibrillation",,NKDA,"['Dyspnoea', 'Hypoaesthesia', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 1058817,NC,80.0,M,Day after have had two bowels movement very black,Not Reported,,Not Reported,Yes,,Not Reported,U,02/25/2021,,,PUB,Tamsulosin .4mg. Metoprol 50mg,None,Only heart valve replaced 15 years ago,,None that would cause appearance,['Faeces discoloured'],2,MODERNA, 1058837,NC,79.0,F,"Patient tested positive for COVID 7 days after receiving her first COVID 19 vaccine. She developed symptoms including shortness of breath, fatigue and headache. She tested positive outpatient for COVID on 2/9",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/25/2021,02/09/2021,15.0,PUB,"alprazolam 0.25 mg, augmentin, apixaban 2.5 mg, atorvastatin 20 mg, Vitamin D3, escitalopram 5 mg, fexofenadine 180 mg, meclizine 25 mg, omega-3 fatty acids, pantoprazole 40 mg, sotalol 40 mg",,"atrial fibrillation, CAD",,aspirin,"['COVID-19', 'Dyspnoea', 'Fatigue', 'Headache', 'SARS-CoV-2 test positive']",UNK,MODERNA, 1058845,TX,88.0,F,"Pfizer-BioNTech COVID- 19 Vaccine EUA Patient received COVID-19 Vaccine dose #2 on February 24, 2021. On February 25th at 10:36 AM,Patient's son called physician to report some side effects to second dose of Covid vaccine. She had diarrhea when she came home yesterday. Son has been up all night with her as patient has had a ""hacking cough,feels terrible, and now has had diarrhea x2"". Patient has taken Advil and will be taking tylenol periodically through out the day for her side effects. Patients son notified physician at 09:55 AM on February 26 that the patient has expired.",Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,,02/24/2021,02/26/2021,2.0,PVT,Aspirin; Calcium carbonate; Cholecalciferol; Cyanocobalamin; Estradiol; Fluticasone; Glipizide; Insulin glargine; Levothyroxine; Losartan; Lutein/zeaxanthin; Mirabegron; Nifedipine; PREVAGEN; Omeprazole; Pramipexol; Pravastatin; Sertraline;,,Generalized anxiety disorder; Restless legs syndrome; Mixed diabetic hyperlipidemia associated with type 2 diabetes; Allergic rhinitis; CKD stage 3 due to type 2 DM; GERD with esophagitis; Hypertension in Stage 3 CKD; Lumbar Spondylosis; Major Depression; Mixed incontinence; Obstructive sleep apnea on CPAP; Osteoarthritis; History of renal cell carcinoma; Type 2 diabetes mellitus; venous stasis dermatitis bilateral lower extremities; venous insufficiency; Vaginal atrophy; Gastroparesis; Insomnia; Acquired hypothyroidism; Recurrent UTI; Oropharyngeal dysphagia; S/P repair of paraoesophageal hernia; lactose intolerance; Sensorineural hearing loss bilaterally.,,Citalopram - itching; Seasonal allergic rhinitis,"['Cough', 'Death', 'Diarrhoea', 'Feeling abnormal']",2,PFIZER\BIONTECH,IM 1058853,NY,51.0,M,"Received 2nd dose of Pfizer on January 19, 2021. 3 days post vaccination (January 22, 2021) I developed right eye discomfort/irritation, prickly sensations in throat. On Jan 25, 2021 I developed tinnitus in right ear which has still not resolved. On January 30, 2021, went to ED with elevated BP 170/110, abdominal pain and tinnitus. Had an abdominal CT scan with contrast which showed mesenteric inflammation (idiopathic etiology). Was seen and evaluated by GI and had colonoscopy and endoscopy with no significant findings. Took solu-medrol dose pack and abdominal pain symptoms improved, but still not fully resolved. On Feb 16 was seen by PCP for persisting, unilateral tinnitus. Sent for MRI Brain which was normal . Referred for further evaluation by audiologist and otolaryngologist . Was seen on February 25, 2021 for right ear fullness, tinnitus. Hearing test normal. Diagnosed with right sided tinnitus.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/19/2021,01/22/2021,3.0,PVT,none,none,GERD,,none,"['Abdominal pain', 'Acoustic stimulation tests normal', 'Blood pressure increased', 'Colonoscopy normal', 'Computerised tomogram abdomen abnormal', 'Ear discomfort', 'Endoscopy normal', 'Eye irritation', 'Magnetic resonance imaging brain normal', 'Mesenteritis', 'Scan with contrast abnormal', 'Throat irritation', 'Tinnitus']",2,PFIZER\BIONTECH,IM 1058892,AZ,76.0,F,"speech/word finding difficulty ( dysarthria ), Novocain like feeling left perioral area( perioral anesthesia ) , drooling of food occasionally",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/03/2021,02/15/2021,12.0,PVT,"levothyroxine, atenolol. babay ASA",none,"hypothyrodism, htn",,"sulfa, levofloxacin","['Angiogram abnormal', 'Aphasia', 'Cerebral small vessel ischaemic disease', 'Drooling', 'Dysarthria', 'Echocardiogram normal', 'Hypoaesthesia oral', 'Magnetic resonance imaging brain abnormal']",UNK,PFIZER\BIONTECH,IM 1058948,NY,66.0,F,"On Saturday, noticed a red band at injection site, lip and tongue tingling. Called doctor, advised to take Tylenol and apply ice pack. Went to walkin clinic., was told to take Benadryl. Told it was COVID arm.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/16/2021,02/20/2021,4.0,PVT,"Synthroid, Crestor, Metoprolol",no,Hashimoto's Thyroiditis,,sensitive to medications,"['Injection site erythema', 'Paraesthesia oral']",2,MODERNA,IM 1058950,AZ,57.0,M,I woke up at 2:00 am and was dizzy and rolled over and was dizzier with Vertigo - couldn't sit up I couldn't stand up or walk. Son took me to ER - Medical Center - and they put me on an IV and gave me Meclizine. Kept me for obsevation for 36 hours as it was not subsiding (the vertigo). Ruled out stroke with CT scan. They sent me home with Meclizine and I'm still taking it. I get Vertigo every day still.,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,12/24/2020,01/02/2021,9.0,PVT,Tylenol PRN; Metoprolol; Lipitor; Flomax,no,Cancer - but it's in remission - had Kidney cancer but not anymore. Frequent EACs - history of,,Kephlex,"['Blood test', 'Chest X-ray', 'Computerised tomogram normal', 'Dizziness', 'Dysstasia', 'Gait disturbance', 'Vertigo']",1,MODERNA,SYR 1058958,NC,69.0,M,"While sleeping 2 days after vaccine, awoken from sleep by rapid heart racing, followed by immediate reduction of heart rate. Did that twice in 30 minutes. Next day entered hospital for tests. Found elevated troponin levels indicating heart damage. In all experienced 5 similiar events. Now wearing a heart monitor to record further events. Spent 2 days in hospital. Questioning wisdom of second shot on march 17th.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/17/2021,02/19/2021,2.0,PVT,"Clopidogrel, losartin, metoprolol, lipitor",None,"Heart disease, kidney disease",,None,"['Blood test', 'Cardiac monitoring', 'Chest X-ray', 'Electrocardiogram', 'Heart injury', 'Heart rate decreased', 'Palpitations', 'Troponin increased', 'Ultrasound scan']",1,MODERNA,SYR 1058963,WI,91.0,F,2/182021: Witnessed cardiorespiratory arrest with PEA arrest upon EMS arrival,Yes,02/18/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/18/2021,13.0,PVT,,aortic sclerosis with stenosis as well as mitral and tricuspid,See above,,Protonix and Piroxicam,"['Cardio-respiratory arrest', 'Pulseless electrical activity']",1,UNKNOWN MANUFACTURER,IM 1059001,HI,91.0,F,"Patient had declining health for the past 6 months, dementia and unable to walk. Patient had decreased appetite starting 1/1/21. After 1st vaccine shot patient appetite decreased further. After 2nd vaccine shot patient fatigue increased to the point where she could not get out of bed and had minimal appetite. Patient passed away 10 days after receiving 2nd shot on 2/22/21. Patient did not go to ED and was not hospitalized.",Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,02/22/2021,32.0,PUB,,"Had declining health for the past 6 months, dementia, unable to walk. Decrease appetite after 1/1/21.",,,,"['Death', 'Decreased appetite', 'Fatigue', 'Mobility decreased']",2,PFIZER\BIONTECH,SYR 1059048,TX,72.0,F,"Fever, chills, fatigue, muscle aches, nausea, death 48 hours after injection",Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,OTH,"Aspirin 81 mg once daily, lorazepam 1 mg two tablets once daily, metoprolol er succinctness 100 mg once daily",None,Long QT Syndrome Atrial fibrillation,,None,"['Chills', 'Death', 'Fatigue', 'Myalgia', 'Nausea', 'Pyrexia']",2,MODERNA,IM 1059076,CA,84.0,M,"February 11, 2021 � Arm pain � He starts taking Tylenol as prescribed on day of Vaccination. February 13, 2021 � Stabbing pain on the left side of the head (above his ear) � Poor sleep the next 2 days February 14, 2021 � Spoke to Dr � He ordered a CT Scan and recommended for him to take Tylenol Extra Strength. The headache continues to escalate. February 15, 2021 � He is taken to ER (Hospital) February 16, 2021 � He is released with pain/insomnia medication February 20, 2021 � He is confused, disoriented, repeats things, forgets things, has difficulty functioning normally and sleeping February 21, 2021 � He has difficulty standing, he falls, he has difficulty swallowing. He is taken to ER (Hospital) February 21-26 - He is still at the Hospital. Was diagnosed with Viral Meningitis/Shingles",Not Reported,,Not Reported,Yes,,Not Reported,N,02/10/2021,02/13/2021,3.0,PVT,See end of form for complete listing. Lisinopril 10miligrams Pravastatin 20miligrams Terazosin HCL 10miligrams metFormin HCL (850 miligram) Aspirin 81mg Gingko Biloba 120mg Calcium 600 with vitamin D3 PreserVision (eye vitamin),None,"Diabetes Type 2, Osteoporosis, Arthritis, Heart valve replaced ~20 years ago. Bladder tumors removed ~3-4 years ago.",,None known,"['Abnormal behaviour', 'Computerised tomogram', 'Confusional state', 'Disorientation', 'Dysphagia', 'Dysstasia', 'Fall', 'Headache', 'Herpes zoster', 'Insomnia', 'Memory impairment', 'Meningitis viral', 'Pain in extremity', 'Poor quality sleep', 'Repetitive speech']",1,MODERNA,SYR 1059112,FL,74.0,F,"WEEK 1: fever, chills, headache, weakness WEEK 2: fever, chills, migraines, weakness, GI symptoms WEEK 3: periodic chills, periodic headaches, weakness, periodic exhaustion, GI symptoms, elevated pancreatic enzymes WEEK 4: weakness, GI symptoms, shortness of breath, exhaustion, heart block",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/27/2021,01/28/2021,1.0,OTH,"Black Cohosh, Synthroid, Calcium, Multi-vitamins",No,No,,,"['Asthenia', 'Atrioventricular block', 'Blood test', 'Cardiac pacemaker insertion', 'Cardiac pacemaker replacement', 'Chills', 'Dyspnoea', 'Fatigue', 'Gastrointestinal disorder', 'Headache', 'Migraine', 'Pancreatic enzymes increased', 'Physical examination', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1059171,ID,80.0,F,"Chills, vomiting, worsening confusion. Patient had vomiting that began about 48 hours after vaccine dose. Had subsequent chills. No fever. Evaluated by her primary care provider on 2/26 AM and the ER at Hospital on 2/26 PM. Noted to have chills, nausea and vomiting in the ER. Also noted to have tachycardia, likely related to her atrial fibrillation. She had been unable to take her home medications due to vomiting and had missed her rate controlling medications. She was given IV Zofran and Tylenol with good control of her chills and vomiting.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/23/2021,02/25/2021,2.0,PVT,"Tylenol, aspirin, atorvastatin, coenzyme Q10, Pradaxa, diclofenac topical, diltiazem, glimepiride, memantine, topical triamcinolone",,"Dementia, Atrial fibrillation, CKD, PVD",,"Codeine, Penicillin, Sulfa drugs","['Atrial fibrillation', 'Chills', 'Confusional state', 'Nausea', 'Tachycardia', 'Vomiting']",2,PFIZER\BIONTECH,IM 1059623,AR,73.0,M,"Possible Stroke per Medical examiner but Reported symptoms after covid vaccine 2/11 therefore being considered poss Covid vaccine related also. No hospitalization prior to death. (Symptoms reported to office 2/17) Fatigue, decreased appetite-",Yes,02/25/2021,Not Reported,Not Reported,,Not Reported,,02/11/2021,02/17/2021,6.0,UNK,"ZYLOPRIM; amino acid; ELIQUIS; vitamin C; aspirin; LIPITOR; atorvastatin calcium; CASODEX; COREG; vitamin D-3; COQ 10; colchicine; PRINIVIL, ZESTRIL; IMODIUM; NITROSTAT; KLOR-CON M20; potassium chloride ER; FLMOAX; DEMADEX; triamcinolone ac",0 Nothing Acute Reported,"Arthritis; Atrial fibrillation; Bleeding of eye, right; Cardiomyopathy; CHF (congestive heart failure); Claustrophobia; Coronary artery disease; Dizzy spells; Fractures; Head injury; Heart attack; Hyperlipidemia; Hypertension; Panic attacks; Pneumonia; Prostate cancer; Renal insufficiency; Venous insufficiency",,Penicillins,"['Death', 'Decreased appetite', 'Fatigue']",1,PFIZER\BIONTECH,IM 1060525,,84.0,M,death Narrative: This was reported to VAERS by another entity and records were requested.,Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/20/2021,1.0,OTH,,,,,,['Death'],1,MODERNA,IM 1060527,,74.0,M,"loss of consciousness;febrile Narrative: Patient received his 2nd vaccine at 10am 2/17. That evening he felt subjectively febrile and then suffered a ground level fall at 0400 on 2/18. He did not lose consciousness or injure his head. EMS was contacted and assisted him into bed. At 0600, wife noted increased work of breathing, which prompted another EMS call, who found him hypoxic with fever of 106. He was transported to a community hospital, where he was found to have temp 102.9 and blood pressure in 70s-80s systolic. He was transferred to hospital at 1300 on 2/18/21, requiring norepinephrine for pressure support after fluid resuscitation. He c/o stiffness and soreness all over but presenting ROS was otherwise negative. Patient was treated with 4L IV fluids and vancomycin and piperacillin/tazobactam at the outside ER. Here at the hospital he was treated with vancomycin, piperacillin/tazobactam and levofloxacin along with IV fluids and norepinephrine. Despite this he had several fevers with Tmax 103.5F the night of 2/18-2/19 and he required norepinephrine plus vasopressin overnight to maintain blood pressure. Piperacillin/Tazobactam was discontinued in favor of meropenem. His last fever was at 6am on 2/19. ID consult was obtained 2/19/21 and vancomycin and levofloxacin were weaned off. Ultimately his blood pressure improved and he was weaned off of all vasopressors the morning of 2/20. Notably, he never developed severe hypoxemia at rest while in the ICU, but did require BiPAP non-invasive ventilation at night instead of his usual CPAP to keep his oxygen levels > 90% while sleeping and additionally had desaturations into the low 80% range with exertion from which he was slow to recover. His oxygen saturation was >90% on 30-40% FiO2 via aerosol mask overnight and 3L (his current baseline) NC during the day. He was transferred out of the ICU on 2/21 based on hemodynamic improvement, stable oxygenation, and improved mentation and symptoms. Unfortunately, on the morning of 2/22/21, patient had an abrupt change in status and was found to be unresponsive with hypercarbic respiratory failure and hypotension. ABG during this event was 7.16/121/65. BiPAP was initiated as patient's code status was DNR/DNI. CXR with no significant change from 2/18/21. CT of head without contrast was negative for acute processes. Based on lack of rapid improvement, the decision was made by wife to transition to comfort care. Patient died at 1446 on 2/22/21. **Of note: patient was admitted for 1 week for covid 19 pneumonia November 2020. During this hospitalization he was found to have chronic R sided PE, no acute PE.",Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/18/2021,1.0,OTH,,,,,,"['Bilevel positive airway pressure', 'Blood gases abnormal', 'Blood lactic acid increased', 'Blood lactic acid normal', 'Blood urine', 'Body temperature increased', 'Cardio-respiratory arrest', 'Chest X-ray', 'Chest X-ray abnormal', 'Computerised tomogram head normal', 'Death', 'Differential white blood cell count abnormal', 'Dyspnoea', 'Fall', 'Full blood count', 'Haematocrit decreased', 'Haemoglobin decreased', 'Hypotension', 'Hypoxia', 'Intensive care', 'Musculoskeletal stiffness', 'Oxygen saturation decreased', 'Pain', 'Platelet count normal', 'Pyrexia', 'Red blood cells urine', 'Respiration abnormal', 'Respiratory failure', 'SARS-CoV-2 test negative', 'Unresponsive to stimuli', 'Urinary occult blood positive', 'Urinary sediment present', 'White blood cell count increased']",1,MODERNA,IM 1062961,NJ,90.0,M,Called patient to refill medication and spoke with daughter. She stated that her father had passed away last week.,Yes,,Not Reported,Not Reported,,Not Reported,,,,,UNK,veltassa,,"hypothyroidism, benign prostatic hypertrophy, hyperkalemia, stage 5 CKD on dialysis",,,['Death'],UNK,PFIZER\BIONTECH,IM 1062962,,61.0,F,[COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA),Yes,02/15/2021,Yes,Yes,,Not Reported,,01/28/2021,02/04/2021,7.0,UNK,,,"61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine (Pfizer) on 1/28/21. Upon arrival to triage she was obviously dyspneic with significantly low oxygen saturations. O2 sats on arrival were 65%, improved to mid 90's with O2 6 liters per NC. Admitting diagnosis: hypoxic respiratory failure post COVID vaccine. Lab work shows an elevation of the BUN and creatinine at 31 and 1.71 which is slightly higher than her usual baseline levels. BNP is elevated at 2 448 with a mildly elevated troponin. Procalcitonin is also elevated. Patient's white blood cell count is 11/07. Full viral panel including COVID-19 is not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, Thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 2/8/2021 and the VV ECMO cannulation on 2/13/2021. EGD done 2/14/2021 as unable to pass the TEE probe during cannulation prior day (unable to complete due to abnormal anatomy). Acute pupil exam change in the early am hours of 2/15/2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. GOL engaged and patient not an organ donation candidate. Therefore discussion with sister at bedside resulted in decision for cessation of life support. Patient expired shortly after support withdrawn and pronounced dead on 2/15/2021 at 11:11 AM.",,,"['Blood creatinine increased', 'Blood culture negative', 'Blood urea increased', 'Brain natriuretic peptide increased', 'Cerebral haemorrhage', 'Chest X-ray abnormal', 'Computerised tomogram head abnormal', 'Culture throat negative', 'Death', 'Diarrhoea', 'Dyspnoea', 'Endotracheal intubation', 'General physical health deterioration', 'Immunoglobulin therapy', 'Lung opacity', 'Nausea', 'Oesophagogastroduodenoscopy', 'Oxygen saturation decreased', 'Paralysis', 'Procalcitonin increased', 'Pupillary light reflex tests', 'Respiratory failure', 'SARS-CoV-2 test negative', 'Troponin increased', 'Ventricular drainage', 'White blood cell count increased']",UNK,PFIZER\BIONTECH,IM 1059190,MO,37.0,F,"Elbow, wrist, knee, hip, ankle, proximal finger joints, proximal toe joints throbbing aching pain",Not Reported,,Not Reported,Not Reported,,Yes,N,01/28/2021,01/29/2021,1.0,PUB,Wellbutrin/naltrexone Zyrtec Synthesis Vitamin D,None,Seasonal allergies Hypothyroidism Asthma Depression Obesity,,NKDA,"['Anti-cyclic citrullinated peptide antibody', 'Arthralgia', 'C-reactive protein', 'Pain', 'Red blood cell sedimentation rate', 'Rheumatoid factor']",2,MODERNA,IM 1059207,AL,73.0,M,Unknown symptoms overnight. Appears patient passed away sometime after waking up next morning after receiving vaccine.,Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/23/2021,1.0,PHM,,,"Heart disease, strokes",,,['Death'],1,MODERNA,SYR 1059221,MD,22.0,M,"Moderna COVID-19 Vaccine EUA The patient was in his usual state of health until he received his second dose of the Moderna COVID-19 vaccine on Tuesday 2/23. He had previously had no side effects from the first dose other than soreness at the injection site. After the 2nd dose, he noticed arm soreness at the injection site more quickly than before. 10-12 hours later, he noticed headache and subjective fever, which was relieved by Tylenol. On Wednesday he woke up with subjective fever and chills, and felt sternal chest pain during deep breathing and attempted cough, but did not notice any effect from positional changes. Other than attempting to cough to elicit pain, he did not experience any other symptoms such as runny nose, coughing, sneezing, congestion, shortness of breath, palpitations, abdominal pain, diarrhea, or dysuria. The following day, he noticed that the chest pain was more severe and persistent throughout the day. The pain location would vary from the sternal area to the left side of his chest. The intensity of pain would vary between a 2-3/10 to 7-8/10. When the pain peaked, it would be accompanied by feelings of fever, chills, and brief headache, and he felt that the pain would ""spread"" across his chest. The pain would persist for a variable amount of time but then eventually disappear before returning. The pain was not affected by deep breath, position, or analgesics (he took an ibuprofen at around 2 AM when he couldn't sleep). After he fell asleep he was not woken up by pain. On Friday, he pain continued to be intermittent, and peaked during a work meeting. At that point he told his boss and an MD co-worker, who recommended that he presented to the ED. The EKG that was obtained in triage showed sinus tachycardia widespread ST elevations, PR depressions, with reciprocal changes in aVR. At this time he was continuing to experience chest pain. After getting a room in the ED, he no longer felt pain. He received a 2nd EKG showing improvement in ST elevations in some, but no all leads. He received ibuprofen and he continued to feel no symptoms. He was found to have a troponin elevation of 8.84 that peaked to 11.2. Transthoracic echo showed no motional wall abnormalities, normal EF, no pericardial effusion. He was admitted to the CICU out of concern and workup for myopericarditis.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/23/2021,02/24/2021,1.0,PUB,None,None,None,,None,"['Blood lactic acid', 'Chest pain', 'Chills', 'Cough', 'Echocardiogram', 'Ejection fraction normal', 'Electrocardiogram PR segment depression', 'Electrocardiogram ST segment elevation', 'Electrocardiogram abnormal', 'Fibrin D dimer', 'Headache', 'Injection site pain', 'Intensive care', 'Painful respiration', 'Pyrexia', 'SARS-CoV-2 test', 'Sinus tachycardia', 'Troponin increased', 'Viral test']",2,MODERNA,IM 1059241,TX,65.0,F,Face red Coughing Trouble breathing Nauseous Heart racing Fainted Inability to speak due to throat swelling up,Not Reported,,Yes,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PVT,Allegra Levothrozine Potassium Estradiol Prilosec Singular Amlodipine Epi pen Pro air symicort,High blood pressure Copd Lupus Fibromylagia Asthma Tmj Allergies,Anaphlatic reactions to meds and foods,Flu,Codeine Demerol Steroids Levequin Onions Eggs,"['Aphasia', 'Cough', 'Dyspnoea', 'Erythema', 'Lack of spontaneous speech', 'Nausea', 'Palpitations', 'Pharyngeal swelling', 'Syncope']",1,MODERNA,SYR 1059243,,31.0,M,"Cardiac event with ST elevation on EKG, and elevated troponin. Pt has no cardiac history.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/19/2021,02/27/2021,8.0,MIL,None noted,None noted/reported,None reported,,NKDA,"['Cardiac discomfort', 'Electrocardiogram ST segment elevation', 'Troponin increased']",2,MODERNA,IM 1059258,MN,82.0,F,Dyspnea and fatigue with elevated troponin followed by hospital admission and subsequent PEA/Bradycardic arrest. Subdural hematoma found. EF 25%. Likely underlying undiagnosed MM.,Not Reported,,Yes,Yes,2.0,Yes,N,02/25/2021,02/26/2021,1.0,UNK,Calcium Zyrtec Tylenol,Lumbar compression fracture Likely undiagnosed multiple myeloma Undiagnosed cardiomyopathy with EF 25%,None documented.,,environmental allergies,"['Anaemia', 'Bradycardia', 'Cardiac arrest', 'Computerised tomogram head abnormal', 'Dyspnoea', 'Ejection fraction decreased', 'Fatigue', 'Lactic acidosis', 'Plasma cell myeloma', 'Pulseless electrical activity', 'Subdural haematoma', 'Troponin increased']",1,PFIZER\BIONTECH,IM 1059317,,65.0,M,"Patient complaining of lightheadedness, room-spinning, feeling of falling over. Denies any reaction after the first dose. RRT was called after abnormal vitals obtained (HR 160-180s, BP 80/60, O2sat 97%, RR 18)",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/25/2021,02/25/2021,0.0,UNK,,,,,,"['Balance disorder', 'Dizziness', 'Vertigo', 'Vital signs measurement']",2,PFIZER\BIONTECH,IM 1059344,KY,74.0,F,death 2/25/21,Yes,02/25/2021,Not Reported,Not Reported,,Not Reported,N,01/16/2021,02/25/2021,40.0,SEN,,,,,,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",UNK,PFIZER\BIONTECH, 1059356,PA,85.0,M,Pt fell within 24 hours after vaccine. was sent to hospital. pt was found to be hypoxic with multifocal opacities on CT scan,Yes,02/16/2021,Not Reported,Yes,,Not Reported,N,02/06/2021,02/07/2021,1.0,SEN,"Lasix, spironolactone, Lipitor, lisinopril, finasteride, Eliquis, paroxetine, Procardia, trazadone",UTI,"Afib, CHF, Alzheimer's, bradycardia ( officially diagnosed march 2019)",,"sulfa, pet dander","['Computerised tomogram abnormal', 'Fall', 'Full blood count', 'Hypoxia', 'Lung opacity']",1,PFIZER\BIONTECH,IM 1059360,,90.0,M,"Cardiac arrhythmia, EMS on site within minutes, outcome of death.",Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,,01/22/2021,02/05/2021,14.0,OTH,,None,"Coronary artery disease, arrhythmia",,None,"['Arrhythmia', 'Death']",1,MODERNA,IM 1059363,TX,79.0,M,"Several neurological impacts, including slurred speech, leg pain, tremors, slowed comprehension, and as days went by leading up to hospitalization, loss of ability to speak in complete sentences.",Not Reported,,Not Reported,Yes,13.0,Yes,N,02/04/2021,02/09/2021,5.0,PHM,Blood Pressure medicine. Advil.,None,Blood pressure.,,None,"['Aphasia', 'Body fluid analysis', 'Bradyphrenia', 'Dysarthria', 'Hypovitaminosis', 'Lumbar puncture normal', 'Magnetic resonance imaging normal', 'Neurological symptom', 'Pain in extremity', 'Sensory processing disorder', 'Tremor', 'White blood cell count decreased']",1,MODERNA,SYR 1059400,OH,60.0,F,"Immediately after the injection - fever within 24 hours, chills, achy, fatigue. Fever for 4 day and fatigue and achy/joint pain lasted for at least a couple weeks. On February 11/12, 2021 started with double vision, progressively getting worse and constant starting on 2/17. Sought medical treatment on 2/18 with emergent MRI ordered and completed on 2/18. MRI results showed swelling/inflammation in the brain, specifically on the left side. Treatment thus far has been antiviral medication, seeing specialists - Ophthalmologist and Neurologist on 2/24 and 2/25 respectively. Further treatment is ongoing but will include ongoing lab work, IVIG infusions starting 3/1 for 3 consecutive days, repeat MRI, potential LP and Quarantine for a minimum of 30 days following the first IVIG treatment. Neurologist diagnosis is ADEM at this time.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/19/2021,01/20/2021,1.0,WRK,"Lisinopril-hctz 20/25, vitamin D, 81 mg aspirin, multivitamin",,,,latex,"['Acute disseminated encephalomyelitis', 'Arthralgia', 'Brain oedema', 'Chills', 'Diplopia', 'Fatigue', 'Immediate post-injection reaction', 'Immunoglobulin therapy', 'Laboratory test', 'Magnetic resonance imaging brain abnormal', 'Noninfective encephalitis', 'Pain', 'Pyrexia']",2,MODERNA,SYR 1059419,CA,76.0,F,"immunothrombocytopenia refractory to platelet transfusions, starting steroids and IVIG",Not Reported,,Yes,Yes,,Not Reported,,02/01/2021,02/23/2021,22.0,PVT,"amlodipine, atorvastatin, Bumex, synthroid, melatonin, pantoprazole, PEG",,"ILD on 2.75 L on home O2, severe RV dysfunction and pulmonary hypertension (WHO class 3), CKD 5, RCA MI secondary to coronary dissection during cardiac cath status post root repair and single-vessel bypass in 2006, A. fib on Eliquis, and sick sinus",,"levaquin, coumadin","['Immune thrombocytopenia', 'Immunoglobulin therapy', 'Melaena', 'Mouth haemorrhage', 'Petechiae', 'Platelet count', 'Platelet count decreased', 'Platelet transfusion', 'Transfusion']",1,PFIZER\BIONTECH,IM 1059421,MN,91.0,F,"After the second vaccine dose she reported not feeling well with unspecified symptoms for a few days. On February 18th, 2021 she visited her doctor with numbness in her hand. They thought it may be carpal tunnel and sent her home. The morning or March 18th , 2021 she had a severe stroke and was transferred to Hospital and then to other hospital. She was in the hospital until Tuesday March 23rd when she was transferred back to her home for hospice care. She died on March 26th, 2021.",Yes,02/26/2021,Not Reported,Yes,5.0,Not Reported,N,02/10/2021,02/11/2021,1.0,SEN,Not Known,None,Arthritis - Macular Degeneration,,None Known,"['Brain injury', 'Cerebrovascular accident', 'Death', 'Hypoaesthesia', 'Magnetic resonance imaging abnormal', 'Magnetic resonance imaging brain abnormal', 'Malaise', 'Surgery', 'Thrombectomy', 'Thrombosis']",2,PFIZER\BIONTECH,IM 1059445,NY,47.0,M,"On 2/23/21, about 12 days after the vaccine was received, I felt chest pains in the late afternoon. At midnight, I woke up with uncontrollable chills and shakes, with a low-grade fever that hovered in the 99.5 -100 range. I attempted to get up and struggled to breathe,; it was as if my abdominal and lower back muscles were seizing. I had to crawl to a kneeling position to urinate. I took several Tylenol then went back to lie down; after a few hours, the fever subsided, and I was able to briefly fall back asleep. At 4:00 a.m. the fever and major chills subsided, with no fevers reported since then, and only occasional chills. However, the muscle fatigue, pain and stiffness have become frighteningly debilitating. On Wednesday - Friday, the three days after I first experienced symptoms, each day it took me between 1.5 - 2 hours to get out of bed and finally get to a standing position. During the day on each day following my first symptoms, I have been able to gradually walk around, go up and down stairs, use the bathroom, and perform basic tasks. However, when the evening comes, it is a different story. 12 midnight - 10 a.m. are the worst hours, as any extended period lying down results in my muscles seizing, freezing and stiffening up. After falling asleep for an hour, it takes 10-20 minutes to mobilize enough (using a crutch and assistance) to get to the bathroom. After falling asleep for 2-3 hours, it takes 30-40 minutes to do the same. And, if I fall asleep for 3+ hours (which is about as long as I've been able to sleep since the adverse reactions began), it will take 1.5 - 2 hours to get completely mobile. This is when I finally wake for the day, and it takes about 10 minutes to raise my head and turn my torso, then another 10-15 minutes to get my legs off the bed and assume a crouching position, then 30-60 minutes to stand on my own.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/11/2021,02/23/2021,12.0,OTH,none,none,none,,"environmental allergies (dust, pollen, etc.) almonds","['Asthenia', 'Blood test', 'Chest pain', 'Chills', 'Computerised tomogram', 'Dyspnoea', 'Dysstasia', 'Gait disturbance', 'Mobility decreased', 'Muscle fatigue', 'Musculoskeletal stiffness', 'Pyrexia', 'Sleep disorder', 'Tremor', 'Walking aid user']",1,MODERNA,SYR 1059452,MA,93.0,M,"Low platelets, thrombocytopenia, bleeding from mouth, large bruising, purpura, petechiae, rash of pinpoint-sized reddish-purple spots on lower legs. Treated with at least 2x2 units of platelets, IVIG for several days (at least), diagnosed as ITP, immune thrombocytopenia. Developed aspirational pneumonia in hospital. Admitted with platelets at 1x10^9/L; discharged on day 5 with 79x10^9/L. Patient had ITP 10 years earlier and was recovered from it.",Not Reported,,Yes,Yes,5.0,Not Reported,Y,02/10/2021,02/21/2021,11.0,PHM,"AREDS, Multivitamins",none,high blood pressure,,Dermal allergy to neosporin,"['Contusion', 'Immune thrombocytopenia', 'Immunoglobulin therapy', 'Mouth haemorrhage', 'Petechiae', 'Platelet count decreased', 'Pneumonia aspiration', 'Purpura', 'Rash', 'Thrombocytopenia']",UNK,PFIZER\BIONTECH,SYR 1059471,TX,62.0,M,Patient experience sudden cardiac arrest approximately 2 minutes after vaccine was administered. Paramedics on scene provided CPR and defibrillation and pulse was restored. Patient was regained consciousness prior to transport to the hospital.,Not Reported,,Yes,Yes,,Not Reported,U,02/26/2021,02/26/2021,0.0,OTH,,,,,,"['Cardiac arrest', 'Cardioversion', 'Immediate post-injection reaction', 'Loss of consciousness', 'Resuscitation']",2,PFIZER\BIONTECH,IM 1059501,,57.0,F,"Nausea, hot flashes, cleared by medic",Yes,,Not Reported,Not Reported,,Not Reported,,02/27/2021,02/27/2021,0.0,UNK,,,,,,"['Hot flush', 'Nausea']",1,PFIZER\BIONTECH,IM 1059558,MD,24.0,M,"On 2/24/21 around 1:30 PM, Patient was not feeling well and temperature was 100.8. He was able to take Tylenol but then the staff noted his eyes rolled back in his head. 911 was called but he was not transported since his temperature was now normal and he seemed to be at baseline. He did not eat or drink much liquids later that night and in the morning of 2/25/21 around 9 AM, staff could not get him up from bed. He was incontinent and had temperature of 97.7. He was staring off and not talking or responsive. 911 was called and he was transferred to the ER and later admitted. All labs and Xrays were normal and later on 2/26/21 he was awake and alert. Of note, Patient also received news on the afternoon he got his second vaccine that a favorite staff person had been killed in a MVA. Patient was upset at this news at the time.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/23/2021,02/24/2021,1.0,OTH,"Benztropine, Clonidine, Divalproex, Doxepin, FLonase nasal spray, Chest rub, Levothyroxine, Loratadine, Montelukast,Paliperidone, Risperidone, Trazadone and Vitamin D.",None,"Intellectual disability, Hypothyroidism, Mood disorder, Oppositional Defiant Disorder, ADHD, Insomnia, Allergic Rhinitis, Speech impairment with jaw deformity and orthodontic braces, astigmatism, History of Dandy Walker Syndrome",,"Cats, dogs, dust and mold and other seasonal allergies","['Aphasia', 'Body temperature increased', 'Decreased appetite', 'Emotional distress', 'Eye movement disorder', 'Incontinence', 'Laboratory test normal', 'Malaise', 'Staring', 'Unresponsive to stimuli', 'X-ray normal']",2,MODERNA,IM 1059588,MI,38.0,F,"8 mins after the shot my throat started burning, heart pounding, shaking uncontrollably, throat felt like it was sticking together, dizzy, lost all my color, hives, tunnel vision, kept almost passing out. Medical personal on site hooked me up to a blood pressure machine. Tested my sugar. My blood pressure was high. They gave me a shot of Benadryl in my left arm. Symptoms seemed to improve for a few minutes. Then came right back. I was going to pass out so they laid me down and called 911. I was rushed to the Emergency Room. Symptoms persisted and they gave me a shot of ephedrine, steroid, and Pepcid. I was kept for observation and sent home with two prescriptions. EpiPen's and steroids. My symptoms persist even to this day. I still do not feel right. My hives have pretty much gone away but I am still feeling off balance and unwell.",Not Reported,,Yes,Not Reported,,Not Reported,U,02/24/2021,02/24/2021,0.0,OTH,Vitamins: D3 Biotin Zinc B50,no,I have asthma and factor five,,none,"['Balance disorder', 'Dizziness', 'Feeling abnormal', 'Hypertension', 'Malaise', 'Oropharyngeal discomfort', 'Pallor', 'Palpitations', 'Throat irritation', 'Tremor', 'Tunnel vision', 'Urticaria']",1,MODERNA,IM 1059633,MS,75.0,M,"Shortness of breath, jaundice, chest pain, vomiting, O2 sat dropped to 87-95%, bilirubin 16, Hgb 6.7, Hct 15, elevated BNP and troponin, required 2.5 L of O2, and 2 units of blood, 3 night hospital stay, discharged 2/26/21.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/20/2021,02/22/2021,2.0,OTH,Corlanor Effexor Plavix Lasix Thyroid Nitroglycerin Vitamin D Folic Acid Aspirin,Heart attack,Cardiac issues Cold agglutinin disease,,Adhesive,"['Blood bilirubin', 'Brain natriuretic peptide increased', 'Chest pain', 'Chromaturia', 'Dyspnoea', 'Echocardiogram', 'Haematocrit', 'Haemoglobin', 'Jaundice', 'Oxygen saturation decreased', 'Transfusion', 'Troponin increased', 'Vomiting']",2,MODERNA,IM 1059644,OH,88.0,M,Pt had a stroke the night after receiving the vaccine.,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/25/2021,01/25/2021,0.0,PHM,,,,,,['Cerebrovascular accident'],1,PFIZER\BIONTECH,IM 1059651,TX,30.0,F,"Patient's hip started having pain around 2 hours after vaccine. Stiffness in the joint started progressing to the point of patient having trouble taking off her socks and walking. Patient was walking with a painful limp. At 12:30 AM on 2-1-21 patient awoke with pain radiating down left leg and could not bend leg or move in bed. The pain lessened a Medrol pack relieved pain for two days. On 2-4-21, patient awoke with such pain that she went to the emergency room. Sciatica was the diagnosis which patient has never had. Patient awoke with severe pain again on 2-7-21 and had another trip to the emergency room. Sciatica was determined the problem again and a CT was ordered that showed no back or disc issues. Pain and difficulty walking has continued to persist even with medication and physical therapy. Patient is using a walker with continued decreased strength and pain in the left leg and hip.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/31/2021,01/31/2021,0.0,PHM,none,none,none,,none,"['Arthralgia', 'Asthenia', 'Computerised tomogram', 'Gait disturbance', 'Joint stiffness', 'Loss of personal independence in daily activities', 'Magnetic resonance imaging', 'Pain', 'Pain in extremity', 'Sciatica', 'Walking aid user']",1,MODERNA,IM 1059672,ID,50.0,F,"Dizziness, that turned into a Syncopal event, resulting in a fall, that resulted in a broken ankle and concussion. Transported to nearest hospital, I had to have emergency surgery on left ankle, by Dr. A plate and screws were placed in my ankle to stabilize the break. I am being treated and monitored by my general doctor for the concussion. I am currently non-weight bearing on my ankle, for a minimum of 2-4 weeks. I am unable to work due to the ankle break and concussion, for an undetermined amount of time. I am scheduled to meet with Dr. on the 4th of March, at which time he stated he will want to begin physical therapy, once the break has reached an adequate stage of healing. I will be re-evaluated by my general Dr. for the concussion in 2 weeks.",Not Reported,,Not Reported,Yes,2.0,Yes,N,02/17/2021,02/18/2021,1.0,PVT,"Protonix, Gabapentin",,,,"Eggs, Codeine","['Ankle fracture', 'Concussion', 'Dizziness', 'Fall', 'Impaired work ability', 'Open reduction of fracture', 'Syncope']",2,PFIZER\BIONTECH,SYR 1059679,VA,55.0,F,Stroke Bala Gangria catastrophic stroke,Not Reported,,Yes,Yes,33.0,Yes,N,01/30/2021,02/03/2021,4.0,PVT,Thyroid medicine,None,None .,,None,['Basal ganglia stroke'],1,PFIZER\BIONTECH, 1059739,MA,74.0,F,"Patient received 2nd dose of Moderna vaccine on 2/26/2021 at 1630 Today she woke up 2/27/2021 feeling okay initially. At 1145 she developed a shaking chill. At 1215 she suddenly became short of breath. Her husband called 911; EMS arrival room air oxygen saturation in the 80s, placed on CPAP. Patient found to have lowgrade fever. (Patient does have a history of OSA and CHF)",Not Reported,,Not Reported,Yes,,Not Reported,U,02/26/2021,02/27/2021,1.0,PVT,Patient is medicated on: carvedilol 25 mg exemestane 25 mg furosemide 20 mg lisinopril 40 mg methiaxole 5 mg pravastatin 40 mg,Unknown/Unable to obtain,"History of breast cancer status post mastectomy History of CHF History of Grave's disease, Hashimoto's thyroid History of cardiomyopathy History of sleep apnea (CPAP at night)",,NKA,"['Blood gases', 'Brain natriuretic peptide', 'Chills', 'Continuous positive airway pressure', 'Dyspnoea', 'Pyrexia', 'Troponin']",UNK,MODERNA, 1059745,OH,80.0,M,"Per Patients Wife - Same day - Flu like symptoms, Nausea, Headache. Restless that night. Next day - Weak, shortness of breath. Wife called squad to get him out of his wheelchair but patient refused hospital as it gets him agitated. Patient passed away around 11 AM the day after vaccination.",Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/23/2021,0.0,PHM,,,,,None,"['Asthenia', 'Death', 'Dyspnoea', 'Headache', 'Influenza like illness', 'Nausea', 'Restlessness', 'Wheelchair user']",UNK,PFIZER\BIONTECH,IM 1059748,FL,34.0,F,"I went into preterm labor at 20 weeks, 3 days on and delivered a live pre-term baby boy who died shortly thereafter. He weighed 11 oz. My estimated delivery date was to be 06/25/2021. This was my second pregnancy, and I had not had my 20 week ultrasound yet. There is no known cause of why I experienced pre-term labor and an autopsy was not performed on my son. My first pregnancy was uneventful and I delivered at full-term.",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/22/2021,02/08/2021,17.0,OTH,"Pre-natal Vitamin, Tylenol, Rhinocort nasal spray",,,,KNA/KNDA,"['Exposure during pregnancy', 'Premature delivery', 'Premature labour']",1,PFIZER\BIONTECH,IM 1059786,MN,56.0,F,"Developed fatigue, cough, and shortness of breath 1 day after 2nd dose of vaccine. Started on antibiotics and steroids empirically prior to admission 02/15. Initial CT with diffuse centri-lobular tree and bud opacities. Infectious (including BAL) and autoimmune work-up without clear explanation for infiltrate. Underwent VATS wedge resection for tissue diagonsis. Post-op developed hypoxia requiring up to 10L O2 and worsening infiltrates on CT in a pattern consistent with organizing pneumonia (possibly drug reaction). Started empirically on steroids for concern for organizing PNA/hypersensitivity pneumonitis. Pathology returned with organizing pneumonia with increased eosinophils. Timing of onset of symptoms is concerning for a hypersensitivity reaction to the COVID vaccine. Symptoms are improving with steroids (started 02/26). Recovery to be determined but I am optimistic for a good recovery.",Not Reported,,Yes,Yes,,Not Reported,N,01/28/2021,01/29/2021,1.0,WRK,,,Obstructive Sleep Apnea Ulcerative Colitis,body aches and fatigue for 3 days with Influenza vaccine in 2007-2009. No symptoms with vaccine since.,,"['Antinuclear antibody', 'Computerised tomogram abnormal', 'Cough', 'Dyspnoea', 'Eosinophil count increased', 'Fatigue', 'Hypoxia', 'Lung opacity', 'Organising pneumonia', 'Pathology test', 'Pulmonary resection', 'Thoracic operation']",UNK,PFIZER\BIONTECH, 1059800,TX,21.0,M,"Patient developed typical fever, myalgias, body aches in the days after his vaccine. He would describe them as severe. This was followed by chest pains. These chest pains prompted him to seek care in the ER. Upon workup, I found the patient to have developed myocarditis with a significantly elevated troponin prompting hospitalization.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/22/2021,02/25/2021,3.0,PUB,None,None,None,,Penicillin,"['Chest X-ray', 'Chest pain', 'Computerised tomogram thorax', 'Drug screen', 'Electrocardiogram', 'Full blood count', 'Metabolic function test', 'Myalgia', 'Myocarditis', 'Pain', 'Pyrexia', 'Troponin increased', 'Urodynamics measurement']",2,PFIZER\BIONTECH,IM 1059805,NY,37.0,F,"Initial imbalance, ""floppiness"" Persistent fatigue 1 week later, onset of cognitive symptoms and insomnia -difficult time finding things at home, even when right in front of her (visuospatial inattention), misplacing things - missing words and wrong tense when writing, paraphasias, misspellings -trouble following stories communicated to her verbally -trouble understanding sentences she had typed -difficulty expressing her reasoning in document writing while at work -poor concentration Also onset of mild anxiety and fluctuating sadness Intermittent early satiety and lack of appetite Treatment: Melatonin 6mg 3-5hrs before sleep CBD oil 50mg nightly (she had started this before presenting to me on 1/30/21) I started her on gabapentin 300mg, she had some relief of sleep onset insomnia, still had middle-of-night awakenings without return to sleep, so added zaleplon PRN for rescue. Zaleplon insufficient duration so switched to Zolpidem PRN. She has not required more than a few doses of zolpidem but now we have uptitrated her to gabapentin 600mg nightly. She feels significant improvement in her sleep and work product, but continues to have intermittent cognitive errors and some decrease in work performance, that remain concerning to her.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/05/2021,1.0,PVT,Tylenol 1000mg Ibuprofen 600mg,,"History of abnormal vaccine reaction (e.coli vaccine, age 25, GI pain requiring hospitalization, thought she had Peyer?s patches ) History of H Pylori Keratitis in college, years of dry eye Mullerian agenesis Had anxiety earlier in life, SSRIs for a few months at a time last at age 28, with EMDR therapy she had significant improvement March-June worked in ED during pandemic and received psychotherapy, but has felt ""fine"" since mid-summer 2020 with no depressive/anxiety symptoms No hx ADHD, learning disorders, but feels that perhaps she has always had a ?mild ADD? in which she gets distracted sometimes, but likes this about herself, it allows her to think more creatively and incorporate more into her work. No trouble progressing academically or professionally, has always performed at the highest levels.","? History of abnormal vaccine reaction (e.coli vaccine, age 25, GI pain requiring hospitalization, thought she had Peyer?s patch","History of abnormal vaccine reaction (e.coli vaccine, age 25, GI pain requiring hospitalization, thought she had Peyer?s patches ) Compazine (dystonia) Long acting benzo made her vomit once, years ago Took ambien in college, this triggered fatigue","['Anxiety', 'Aphasia', 'Balance disorder', 'CSF cell count normal', 'Cognitive disorder', 'Decreased appetite', 'Depressed mood', 'Disturbance in attention', 'Early satiety', 'Fatigue', 'Hypotonia', 'Insomnia', 'Lumbar puncture', 'Magnetic resonance imaging head', 'Viral test negative']",2,MODERNA,IM 1059825,AZ,90.0,M,"30 hours after the first Covid vaccination, the resident was lethargic, non responsive with shortness of breathe.",Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,N,02/24/2021,02/25/2021,1.0,SEN,Donepezil 10mg daily Vitamin D3 5000 IU daily Eliquis 2.5mg twice daily Vitamin B12 1000mcg daily Enalapril 10mg daily Memantine HCL 10mg twice daily Claritin 10mg dai,none while at community- new move in.,Dementia HTN A-Fib Cancer,,NKA,"['Death', 'Dyspnoea', 'Lethargy', 'Unresponsive to stimuli']",1,MODERNA,IM 1059828,NC,65.0,F,Once day after receiving 2nd COVID Vaccine developed diffuse abdominal pain and Intractable nausea with vomiting.,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/24/2021,02/25/2021,1.0,PVT,none,None,None,,None,"['Abdominal pain', 'Computerised tomogram abdomen abnormal', 'Nausea', 'Small intestinal obstruction', 'Vomiting']",2,PFIZER\BIONTECH,IM 1059857,NJ,74.0,M,Headache and syncope with head injury.,Not Reported,,Yes,Yes,1.0,Not Reported,N,02/26/2021,02/27/2021,1.0,PVT,"Baby Aspirin, Finasteride, Tamsulosin",None,BPH,,None,"['Coagulation test abnormal', 'Coagulopathy', 'Computerised tomogram abnormal', 'Haemorrhage intracranial', 'Head injury', 'Headache', 'Laboratory test', 'Syncope']",1,PFIZER\BIONTECH, 1059859,NV,53.0,F,"Numbing on left side of the face, unable to close left eye all the way no control on left side of the lips; sharp pain on neck and jaw",Not Reported,,Not Reported,Not Reported,,Yes,N,12/22/2020,02/16/2021,56.0,PVT,levothyroxine 0.137 mg,none,Hypothyroidism,,none,"['Eyelid function disorder', 'Facial paralysis', 'Facial paresis', 'Hypoaesthesia', 'Lip disorder', 'Neck pain', 'Pain in jaw']",2,PFIZER\BIONTECH,IM 1059863,PA,61.0,M,"First vaccine received on Sat 1/23. On Tues 1/26 began to experience body aches, chills, headache. Spoke to triage nurse on Wed 1/27 who thought were symptoms of vaccine. On Wed 1/27 continued with body aches, extreme chills, headache and developed a 101 fever. On Fri 1/29, went urgent care who continued to attribute the symptoms to the vaccine. On Sun day 1/31, went urgent care again experiencing the same symptoms along wot a 104 fever. Sent to ER and admitted to the hospital. Hospital stay from Sun 1/31 to discharge on Fri 2/5. Admitted to the hospital with pneumonia attributed to my immune system going after the vaccine allowing for the the development of pneumonia.",Not Reported,,Yes,Yes,5.0,Not Reported,U,01/23/2021,01/26/2021,3.0,PVT,levothyroxine metoprolol Lipitor Norvasc Multiple vitamins/supplements,None,High blood pressure High triglycerides Thyroidectomy,,aeroallergens,"['Blood test', 'Chest X-ray', 'Chills', 'Computerised tomogram abnormal', 'Headache', 'Pain', 'Pneumonia', 'Pyrexia']",1,MODERNA,IM 1059893,NC,74.0,F,"Extreme high blood pressure 201/100 , goes from extreme to normal in an hour continuously.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/13/2021,02/14/2021,1.0,PVT,"New Meds: Amlodipine 5 MG and labetalol HCL 109 MG every 12 hours. Old Meds: Atorvastatin 40 MG, Glipizide 5 MG,, one of each daily.",MRI for a hip injury the day before. Results was a torn Ligament. Given a pain med but I didn?t take it.,Type two diabetic,,"Codine, and some antibiotics.","['Blood pressure fluctuation', 'Blood test normal', 'Computerised tomogram normal', 'Hypertension']",2,PFIZER\BIONTECH,SYR 1059996,NE,78.0,M,"Chills, confusion, fevers, nausea, confusion Subsequent precipitous decline in kidney function, required a 4 day in-patient stay",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/01/2021,02/05/2021,4.0,PVT,"Xifaxan, lactulose, sodium bicarbonate, zinc, vitamin D",Nothing acute,"Chronic, controlled hepatic encephalopathy Chronic moderate renal insufficiency",,None,"['Chills', 'Confusional state', 'Laboratory test', 'Nausea', 'Pyrexia', 'Renal impairment', 'Ultrasound kidney', 'Ultrasound scan']",1,MODERNA,SYR 1060027,WA,55.0,F,two syncopal episodes back to back within 24 hours of second dose of vaccine resulting in displaced fracture of proximal phalanx of right little finger. this fracture will require two surgeries to repair and loss of work about 12 weeks,Not Reported,,Not Reported,Not Reported,,Yes,N,02/09/2021,02/10/2021,1.0,WRK,celexa protonix multi vitamin,none,depression fibromyalgia migraines GERD,,benadryl latex allergy/adhesive tape,"['Electrocardiogram', 'Hand fracture', 'Impaired work ability', 'SARS-CoV-2 test', 'Syncope', 'Troponin', 'X-ray']",2,MODERNA,IM 1060080,CA,101.0,F,Death,Yes,01/16/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/16/2021,3.0,SEN,none,none,osteoporosis,,none,['Death'],UNK,PFIZER\BIONTECH, 1060084,AL,66.0,M,Death in the field approximately 1 week after unknown covid vaccination. Unknown time of death. Found by family who hadn't spoke to pt in almost a week.,Yes,02/27/2021,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/27/2021,8.0,UNK,Atenolol,"Copd, htn",,,,['Death'],UNK,UNKNOWN MANUFACTURER, 1060124,CA,74.0,F,"15 minutes after injection, clear nasal drainage. 30 minutes after injection, more clear nasal drainage and slightly bloody nostril. Tired in evening of injection, slight soreness right are. Next day, up performing usual home kitchen activities, reading, making and drinking coffee. Then SUDDENLY at exactly 23 hours after the injection, began experiencing extreme difficulty breathing, unable to speak in full sentences. Called Primary Providers Office and was directed to go to an emergency room ASAP.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/25/2021,02/26/2021,1.0,PVT,,,reactive airway disease when exposed to some aerosol sprays.,,"morphine, demeral","['Aphasia', 'Disorganised speech', 'Dyspnoea', 'Epistaxis', 'Fatigue', 'Pain', 'Rhinorrhoea', 'Sinus operation']",UNK,PFIZER\BIONTECH,IM 1060146,CT,98.0,F,"unresponsiveness, left hemiplegia, no evidence of stroke on imaging",Not Reported,,Not Reported,Yes,,Not Reported,N,02/26/2021,02/27/2021,1.0,PVT,eliquis,none,afib,,zithromax,"['Angiogram normal', 'Computerised tomogram head normal', 'Hemiplegia', 'Unresponsive to stimuli']",2,MODERNA, 1060151,CA,90.0,M,"Fall - 7 AM Fall in Dining Room Community Center 1 PM Ambulance to Hospital ER 1:30 PM Tests - Blood, CT scan of head and brain, X-ray of Chest Release from hospital - 5 PM Arrive by car to home 5:30 PM fall from car to grass Call for Security and Nurse to get him up and into the house - vital signs taken Fall again in the house at 6 PM Seemed to back to normal +/- 7 PM",Not Reported,,Not Reported,Not Reported,,Yes,Y,02/11/2021,02/12/2021,1.0,OTH,Diovan 160 mg Vit C 1000 mg Atorvastatin 10 mg Turmeric Aspirin 81 mg Centrum Silver Vit D3 1000 IU,None,high blood pressure high cholesterol,,None,"['Blood test', 'Chest X-ray', 'Computerised tomogram head', 'Fall', 'Hypotension']",2,MODERNA,SYR 1060190,CA,70.0,M,"Patient received Covid Vaccine Moderna at 1145, multiple syncopal episodes at pharmacy, sent to ER. Outcome Death",Yes,02/27/2021,Not Reported,Not Reported,,Not Reported,N,02/27/2021,02/27/2021,0.0,OTH,unknown,unknown,unknown,,unknown,"['Cardio-respiratory arrest', 'Cerebrovascular accident', 'Computerised tomogram abnormal', 'Death', 'Pulse absent', 'Respiratory arrest', 'Syncope']",UNK,MODERNA,IM 1060204,TX,68.0,F,"Pfizer-BioNTech COVID- 19 Vaccine EUA Approx 5 minute post vaccination, patient began reporting itching. Shortly after, developed a dry cough and reported that her throat ""felt funny."" Patient began vomiting and having difficulty breathing, speaking in 1-2 word sentences. Pt received epi pen to left thigh, with some resolution of symptoms. Pt continued to have cough and nausea, chest pain. Gave 25 mg benadryl IM at 08:27 am. Patient received 2nd dose of Epi for increased SOB, difficulty breathing, and increasing cough, with some resolution of symptoms. Patient reported increased chest pressure. Began having seizure like activity at 08:30, lasting approx 20 seconds with no post ictal period noted. EMS arrived after 2nd dose of epi. Second ""seizure like"" activity after EMS arrival, lasting approx 20 seconds. During transport to ambulance, patient had 2 more episodes of seizure like activity with no post ictal phase. ED note states low suspicion for true seizure since patient was awake during episodes of tonic clonic movements, answering questions during, and did not have post ictal state.",Not Reported,,Not Reported,Yes,,Not Reported,,02/27/2021,02/27/2021,0.0,PVT,"Albuterol Q4H Prn, Amlodipine 5 mg Daily, Atorvastatin 80 mg, Atropine Ophth 1 drop Rt Eye daily, Brimonidine 0.2% 1 drop left eye TID, Buspirone 15 mg TID, Cyanocobalamin 1 tab daily, Dorzolamide-Timolol 1 drop both eyes TID, Epipen PRN, F",,"Atrial Flutter, AV Block 3rd degree, Chronic diastolic heart failure, Hypertension, Coronary Artery Disease, PSVT, COPD, Sleep apnea, GERD without esophagitis, Thyroid nodules, Secondary hyperparathyroidism of renal origin, Type 2 diabetes mellitus, Morton's neuroma of left foot, Onychomycosis, chronic anticoagulation, depression, glaucoma, history of pulmonary embolism, Left knee pain, pacemaker, ptosis of both eyelids, pulmonary nodule, tobacco abuse, vitamin D deficiency.",,"Acetaminophen (angioedema), Azithromycin (itch), Prochlorperazine (itch), Hydromorphone (Hives), Penicillins (Rash), Tramadol (Hives), Wasp venom (Swelling), Duloxetine (tachycardia), Prednisone (rash), Fentanyl (Itch), Aspirin (Hives), Allergy Not Specified for the following: Adhesive, Albumin, Cephalosporins, Cholecalciferol, Flecainde, Hydrocodone, Interferon Beta, Iodine, Morphine, Dronedarone, Propyphene, Sotalol, Sulfanilamide.","['Aphasia', 'Chest discomfort', 'Chest pain', 'Cough', 'Dyspnoea', 'Nausea', 'Oropharyngeal discomfort', 'Pruritus', 'Seizure like phenomena', 'Throat irritation', 'Tonic clonic movements', 'Vomiting']",1,PFIZER\BIONTECH,IM 1060209,VA,66.0,M,"Bell's Palsy, drooping and extreme pain started behind ear on February 22. Getting worse each day. Extreme headache immediately after injection and continues to this day.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/25/2021,02/27/2021,33.0,PUB,,none,,,,"['Ear pain', 'Facial paralysis', 'Headache', 'Immediate post-injection reaction', 'Vaccination complication']",1,MODERNA,IM 1060219,OH,89.0,F,"Trouble breathing, severe fatigue, blood clots in lung and leg.",Not Reported,,Not Reported,Yes,7.0,Not Reported,N,02/05/2021,02/10/2021,5.0,PVT,"Korig, lascis, plavax,",Osteoarthritis,"High blood pressure, osteoarthritis",,None,"['Blood test', 'Chest X-ray', 'Computerised tomogram', 'Dyspnoea', 'Echocardiogram', 'Fatigue', 'Thrombosis', 'Ultrasound scan']",UNK,MODERNA,SYR 1060242,NJ,78.0,F,The patient developed back pain one month after the first injection on February 24 she was diagnosed with pericardial effusion?s and 750 mL was drained from the pericardium. The work up is on going but it seems to be Pericarditis which occurred after the vaccination,Not Reported,,Yes,Yes,2.0,Not Reported,N,01/12/2021,02/01/2021,20.0,PHM,"Plavix,",None,Hypothyroidism,,No,"['Back pain', 'Pericardial drainage', 'Pericardial drainage test normal', 'Pericardial effusion', 'Pericarditis']",1,MODERNA,IM 1060313,WY,73.0,F,"I am not 100% certain of this event being related to the vaccination with the Moderna COVID19 shot or not. However, in the interest of completeness and for investigative purposes, I am reporting to you the event in relation to the vaccination as the patient reported to me. She received the vaccination on 2/14/2021 and became very confused. She had significant left arm swelling much worse than when she had her first vaccination. Her husband brought her to the emergency room and she was eventually discharged, but she went on to develop significant hypertension and she reported that her blood pressures were normal prior to the vaccination. She had an emergency room visit in which her systolic pressures were well above 240. She revisited the emergency room and had elevated blood pressures of 240 and was diagnosed with hypertensive encephalopathy and later found to have posterior reversible encephalopathy syndrome or PRES. We have started the patient on medications, and started laboratory work-up for secondary hypertension and her blood pressures have improved with treatment. We discussed the case with the neurologist, who suggested that we repeat MRI scan to make sure that her punctate lesions noted on MRI on this admission on 2/25/2021, have resolved. It was advised that if they had not resolved that we should call neurology again. Hypertensive encephalopathy is rare and press syndrome as a result is also rare. It is for this reason that I am reporting this event as again, I am not trying to mislead anyone or distort information, but should this be an adverse effect of the vaccine I wanted to make sure that this was reported as the patient's history prior to the vaccination and developing this complication post vaccination are temporally related at a minimum. The patient is a known smoker but quit on the 14th of this month.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/14/2021,02/14/2021,0.0,PVT,"lotensin, amlodipine",none known,she reported none to me.,,hydrocodone,"['Blood pressure increased', 'Blood pressure systolic increased', 'Cardiac stress test normal', 'Computerised tomogram abdomen', 'Confusional state', 'Echocardiogram normal', 'Hypertension', 'Hypertensive encephalopathy', 'Laboratory test', 'Magnetic resonance imaging brain abnormal', 'Peripheral swelling', 'Posterior reversible encephalopathy syndrome', 'White matter lesion']",2,MODERNA,IM 1060314,CA,87.0,F,Mom woke up this morning and has lost all vision following #1 of 2 Covid-19 vaccination on 02/25/2021,Not Reported,,Not Reported,Not Reported,,Yes,N,02/25/2021,02/27/2021,2.0,PVT,Latanoprost Opthalmic Solution 0.005% eye drops Timolol Maleate Opthalmic Solution 0.5% eye drops,Actively being treated for open angle glaucoma,Open angle glaucoma,,none,['Blindness'],1,PFIZER\BIONTECH,IM 1060520,,87.0,M,Pt expired 11 days after receiving vaccine. No indication his passing was related to the vaccine. Narrative: No updated notes regarding cause of death. Patient's wife called to notify the facility of his passing on 1/26/2021,Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/26/2021,11.0,OTH,,,,,,['Death'],1,PFIZER\BIONTECH, 1060529,,88.0,M,"Hypoxia, Decreased responsiveness, Narrative: 86yo male with PMHx HTN, Afib not on AC after head trauma, CVA, and colon cancer who was brought to the ED by his family on 2/17. Per documentation the pt was in his usual state of health until 2/16. Received Moderna covid vaccine #2 on 2/16/21 at 0900, and was monitored for 15 minutes following immunization no noted issues. Later that night, had myalgias and took Tylenol. Per the family he slipped on the ice and fell on his butt. Overnight, had several dark stools and vomitus. was brought to the ED by his family because he was being less responsive. Pt arrived to the emergency department in extremis. No pulse identified. CPR immediately initiated for several rounds lasting about 25-30 minutes. ROSC unable to be achieved. Patient expired on 2/17 at 1941. Of note, per previous documentation had waxing and waning mental status at baseline. No symptoms noted with 1st dose of Moderna vaccine, which was administered on 1/16/21.",Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,OTH,,,,,,"['Death', 'Faeces discoloured', 'Fall', 'Hypoxia', 'Mental status changes', 'Myalgia', 'Pulse absent', 'Resuscitation', 'Terminal state', 'Unresponsive to stimuli', 'Vomiting']",2,MODERNA,IM 1060401,IL,73.0,F,"Site: Pain at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: DEATH-Severe, Systemic: Heart Attack-Severe",Yes,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/09/2021,3.0,PHM,,,,,,"['Cardiac disorder', 'Chest discomfort', 'Death', 'Discomfort', 'Injection site pain', 'Myocardial infarction', 'Pain']",1,PFIZER\BIONTECH,IM 1060415,KY,75.0,M,"The patient is a 75 yr/o male with a history of COPD presents with multiple constitutional symptoms have been present over the past week since getting his second COVID-19 vaccination. Patient states he has had fever and chills, generalized fatigue, body aches, increased sleepiness, and some burning with urination. Patient states his wife took his blood pressure this morning and that it was abnormal prompting the visit to the ER. The patient states all the symptoms started about a day after getting his second COVID-19 vaccination and have been persistent since that time. He states that he has a longstanding history of shortness of breath due to his COPD but no worsening shortness of breath over the past week. Patient denies any chest pain, nausea, vomiting, bowel issues. Patient denies any headache, dizziness, vision changes. Patient does wear corrective lenses. � Per Triage: HOT Fatigue (wife states BP was 67/48 this AM at home, 2nd COVID vaccine 2/19) Fever (all week �since wednesday off/on) Final diagnoses: AKI (acute kidney injury) (CMS/HCC) Elevated CK Body aches Fatigue, unspecified type Transient hypotension",Not Reported,,Not Reported,Yes,,Not Reported,,02/19/2021,02/20/2021,1.0,PVT,,,,,,"['Acute kidney injury', 'Blood creatine phosphokinase increased', 'Blood pressure abnormal', 'Cachexia', 'Chills', 'Dysuria', 'Fatigue', 'Feeling hot', 'Hypotension', 'Metabolic function test', 'Pain', 'Pyrexia', 'Somnolence']",2,PFIZER\BIONTECH,IM 1060454,NY,61.0,F,"In the morning of Thursday February 25 at around 6:5 AM, as I was brushing my teeth, the water was leaking out when swishing from side to side. As the day progress, the right side of my mouth was getting number. The next morning Friday February 26, the right side of my face was numb, my speech was swirl, eating and drinking became challenging. I went to the emergency rom at Hospital where the team of doctors diagnosed me with Bell's Palsy. I was given Prednisone and Valtrex for a period of 7 days. Physical therapy as also being advised. The hospital advise me to follow up with my Primary Care Doctor (schedule for Monday March 1st), and to see a neurologist (waiting for an appt). As of today, the right side of my face has lost mobility.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/21/2021,02/25/2021,4.0,OTH,"Metoprolol 50mg, Hydrochlorothiazide 10mg, atorvastatin 20mg, iclusig 15 mg, Potassium 10 meq Vitamin C 250 mg, Vitamin D 125 mcg","hypertennsion, Chronic Lukemia in remission","Chronic Leukemia in remission, Hypertension",,none,"['Blood glucose normal', 'Dysarthria', 'Facial paralysis', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Mastication disorder']",1,PFIZER\BIONTECH,SYR 1060459,NJ,68.0,M,The following day would not get out of bed. It was clear by @ 6pm he was in shock - called ambulances; hospitalize 3-4 days,Not Reported,,Yes,Yes,3.0,Not Reported,Y,02/20/2021,02/21/2021,1.0,OTH,Hydrocortisone and other hormones; no pituitary functioning since removal of noncancerous tumor,Only those related to loss of pituitary functioning,,,None,"['Mobility decreased', 'Shock']",UNK,MODERNA, 1060469,GA,68.0,F,Have diverticulosis-bleeding issue and had severe bleed that started on 2/24 and subsided on 2/25-26,Not Reported,,Yes,Yes,3.0,Not Reported,Y,02/20/2021,02/24/2021,4.0,SCH,Multivitamin Vit D Vit C Tumaric,None,Diabetics HBP Diverticulosis Heart bypass (2014),,Insaids Steroids,"['Cardiac monitoring', 'Computerised tomogram', 'Condition aggravated', 'Diverticulum', 'Gastrointestinal haemorrhage', 'Haemorrhage', 'X-ray']",2,MODERNA,SYR 1060492,TX,49.0,F,"Lower abdomen pain, leading to high fever, eventually leading to diagnosis of ruptured appendix",Not Reported,,Yes,Yes,5.0,Not Reported,Y,01/11/2021,01/13/2021,2.0,PUB,Sotalol Atenolol D3 B12 baby asprin Zyrtek Omega/Fish Oil Calcium/D3,none,Hypertrophic Cardio Myopathy,,none,"['Abdominal pain lower', 'Appendicitis perforated', 'Computerised tomogram', 'Pyrexia']",UNK,MODERNA, 1060530,NC,59.0,M,"allergic reaction red, swollen and itchy hands and face. swollen tongue ,hard to talk",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/16/2021,02/18/2021,2.0,OTH,none,none,overweight,,none,"['Aphasia', 'Erythema', 'Hypersensitivity', 'Peripheral swelling', 'Pruritus', 'Swollen tongue']",2,MODERNA,IM 1060538,FL,89.0,F,severe vomiting for 36 hours that led to dehydration; loss of sodium and potassium; lack of mobility and hospitalization,Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/22/2021,02/22/2021,0.0,OTH,clopidogrel; listinopril; lasix; atorvasdtatin; amlodipine; carvedilol,none known,heart bypass; high blood pressure,,none,"['Blood potassium decreased', 'Blood sodium decreased', 'Dehydration', 'Hypokalaemia', 'Hyponatraemia', 'Mobility decreased', 'Vomiting']",1,PFIZER\BIONTECH,SYR 1060543,GA,76.0,F,"Began walking on treadmill at 5:30 a.m. and left foot felt heavy and dragging, L hand tingling, and facial/neck numbness. Arrived at hospital at 8:15. Vitals, EKG, CT scan, and MRI conducted. MRI showed an acute mild stroke on R side of brain. Over-night stay was recommended. Echocardiogram was performed the following day and nothing was abnormal. I am now on a heart monitor for 30 days. Upon departure of hospital the symptoms in L leg and arm have nearly resolved but face is still numb/decreased sensation. Plan to contact PCP tomorrow.",Not Reported,,Not Reported,Yes,2.0,Yes,N,02/12/2021,02/24/2021,12.0,PHM,"Calcium, Vitamin D3, Fish oil, B12 injection monthly, Prolia twice per year",None,Pernicious Anemia,,"Penicillin, Compazine, Azythramycin","['Cerebrovascular accident', 'Computerised tomogram', 'Depressed level of consciousness', 'Echocardiogram normal', 'Electrocardiogram ambulatory', 'Gait disturbance', 'Hypoaesthesia', 'Limb discomfort', 'Magnetic resonance imaging abnormal', 'Paraesthesia']",1,MODERNA,IM 1060563,IA,77.0,F,Cerebral hemorrhage acute. Loss of speech. Agitation and confsion.,Not Reported,,Yes,Yes,2.0,Not Reported,Y,02/26/2021,02/27/2021,1.0,PUB,"Enalapril, levothyroxine, clopidogrel, metoprolol, metformin, letrozole, doxycycline, atorvastatin, oxybutynin.",Stage 4 endometrial cancer.,"Hypertension, hypothyroidism, (not diabetes), history of thrombotic stroke, hypercholesterolemia.",,Contrast media,"['Agitation', 'Aphasia', 'Cerebral haemorrhage', 'Computerised tomogram head abnormal', 'Confusional state']",2,MODERNA,IM 1060580,UT,76.0,F,Patient has known lymphoma but was on break from chemotherapy. No known lung disease. She developed a very large left pleural effusion and became markedly hypoxia need chest tube drainage. Multiple fluid cultures were negative for infection and fluid sent twice for cytology and flow cytometry were negative for tumor cells. She was too ?sick? for thoracoscopy. Over the next 7 days the symptoms resolved and the effusion has not returned which speaks against this being from the lymphoma. She had symptoms the night of the vaccine but did not become critically ill for about 36 hours as the effusion was developing. Her oncologist and I both believe this was related to the vaccine and will not give the second dose.,Not Reported,,Yes,Yes,10.0,Not Reported,Y,02/08/2021,02/09/2021,1.0,PUB,"Patient has been on Folatyn chemotherapy for lymphoma but off for 2 weeks Trazadone, Vitamins, Prilosec, Amiodorone",T cell lymphoma in abdomen ( intestine),None except lymphoma,,None,"['Blood culture', 'Chest X-ray', 'Chest tube insertion', 'Computerised tomogram', 'Culture', 'Cytology', 'Drainage', 'Flow cytometry', 'Hypoxia', 'Pleural effusion', 'Vaccination complication']",1,MODERNA,IM 1060599,TX,95.0,F,Pericardial Effusion Bilateral Pleural Effusions,Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/20/2021,01/28/2021,8.0,PVT,Simbrinza Calcium Carbonate Advair Gabapentin Norco atrovent singulair pravastatin Carafate travatan albuterol voltaren,none,history of breast cancer dyslipidemia osteoarthritis,,"codeine, tramadol, amiodarone","['Aspiration pleural cavity', 'Computerised tomogram abnormal', 'Computerised tomogram thorax', 'Pericardial drainage', 'Pericardial effusion', 'Pleural effusion']",UNK,PFIZER\BIONTECH, 1060629,KY,72.0,M,RECEIVED BOTH DOSES OF PFIZER VACCINE ON 01/28/21 & 02/18/21. ON 02/28/21 WENT ER FOR POSSIBLE SEIZURE ACTIVITY. AND DIAGNOSED WITH NEW ONSET SEIZURE AND THROMBOCYTOPENIA AND ADMITTED INPATINET INTO HOSPITAL.,Not Reported,,Not Reported,Yes,,Not Reported,,02/18/2021,02/28/2021,10.0,PVT,,,,,ADRENOCOT (DEXAMETHASONE) CORTICOSTEROIDS,"['Hospitalisation', 'Platelet count decreased', 'Seizure', 'Thrombocytopenia']",1,PFIZER\BIONTECH,IM 1060631,OH,74.0,F,Patient suffered a mechanical fall on steps over 30 minutes after vaccination and sustained a left hip fracture,Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,02/24/2021,02/24/2021,0.0,PVT,"aspirin 81 mg , atorvastatin 80mg, levothyroxine 50 mcg, losartan 100 mg, meloxicam 15 mg , metformin 500 mg, metoprolol tartrate 25 mg, potassium chloride 10 mEq, rivaroxaban 20 mg","hypertension, diabetes mellitus type 2, hyperlipidemia, thyroid disease",history of recurrent pulmonary embolism,,NKDA,"['Fall', 'Hip fracture']",1,MODERNA,IM 1060641,KS,73.0,F,I have had several Hospital Admissions of people who had prior documented COVID 19 infections that then receive the Vaccine after they recovered and then have an inflammatory reaction that is similar to prior symptoms they suffered during their COVID 19 infection.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/26/2021,02/27/2021,1.0,PVT,no new changes,COVID 19 infection in late December 2020 early January 2021,Hyperlipidemia and HTN,,"PCN, Codeine, Ibuprofen",['Inflammation'],UNK,MODERNA, 1060647,KY,81.0,F,"RECEIVED PFIZER COVID VACCINE DOSE ON 02/14/21 WENT TO ER ON 02/28/21 WITH COMPLAINTS OF HEADACHE SHORTNESS OF BREATH, AND 02 SAT 60% ON ROOM AIR. HAD CT HEAD WO CONTRAST THAT WAS POSITIVE FOR HEMORRHAGE AND PLAN IS TO ADMIT TO HOSPITAL",Not Reported,,Not Reported,Yes,,Not Reported,U,02/14/2021,02/28/2021,14.0,PVT,,,,,,"['Angiogram abnormal', 'Brain natriuretic peptide', 'COVID-19 immunisation', 'Computerised tomogram abnormal', 'Computerised tomogram head', 'Dyspnoea', 'Haemorrhage', 'Headache', 'Oxygen saturation', 'Oxygen saturation decreased']",1,PFIZER\BIONTECH,IM 1060651,TX,84.0,F,"Received 1st dose Pfizer-BioNTech vaccine Lot EN9899 exp 03/2021 on 01/18/2021 during CVS onsite clinic for Assisted Living Facility. Received 2nd dose Pfizer-BioNTech vaccine Lot EN5318 Exp 05/2021 on 02/08/2021 during CVS onsite clinic for Assisted Living Facility. On 02/10/2021 during routine employment screening, tested positive for COVID-19. On 02/12/2021 reported generalized malaise, otherwise denied symptoms. On 02/21/2021 employer notified by family friend that patient was treated at Medical Center on 02/20/2021 secondary to sudden onset difficulty swallowing, impaired speech, and facial droop. Employer later notified patient was then admitted to the ICU at aforementioned hospital secondary to dx of CVA.",Not Reported,,Yes,Yes,8.0,Yes,N,02/08/2021,02/20/2021,12.0,SEN,Unknown,Received 1st dose Pfizer COVID-19 vaccine on 01/18/2021; 2nd dose Pfizer COVID-19 vaccine on 2/8/2021; diagnosed with COVID-19 on 02/10/2021 during routine employment screening,Unknown,,Unknown,"['COVID-19', 'Cerebrovascular accident', 'Drug ineffective', 'Dysphagia', 'Facial paralysis', 'Intensive care', 'Laboratory test', 'Magnetic resonance imaging brain', 'Malaise', 'Speech disorder']",2,PFIZER\BIONTECH,IM 1060682,IL,57.0,F,"Patient received first dose 2/16/2021 at 5 PM. Local site reaction (redness) for about 5 days after vaccination. Mild headache for first 12 hours post vaccination. Acute wrist, MCP, PIP and DIP joint pain with swelling, reduced range of motion, redness and warmth in both hands though began first in left hand. Significant pain to the point of not being able to pick up a glass of water. Worse in morning with mild improvement throughout the day. This is brand new symptom that began 2/25/21 temporarily associated with Moderna Covid19 vaccination first dose on 2/16/21.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/16/2021,02/25/2021,9.0,PVT,"Rebif, escitalopram, nexium","Multiple Sclerosis, Gastroesophageal Reflux",Multiple Sclerosis,,none,"['Arthralgia', 'COVID-19 immunisation', 'Erythema', 'Headache', 'Hypokinesia', 'Injection site erythema', 'Joint range of motion decreased', 'Joint swelling', 'Pain in extremity', 'Skin reaction', 'Skin warm']",1,MODERNA,IM 1060690,NY,66.0,M,"right wrist is swollen and un-usable at this time...cannot use for cleaning after bowel movement///am on crutches and very difficult to use left hand left achilles tendon is so painful, i cant bear weight; throbbing having difficulty maintaining equilibrium...I believe I had the virus in march of 2020, though the antibody test i took in may was negative. there may be some question as to the efficacy of the test that was being used at that time",Not Reported,,Not Reported,Not Reported,,Yes,N,02/26/2021,02/27/2021,1.0,SCH,prednisone 5 mg valsartan 40 mg navajo tea ( thelesperma subnudum ) was not taking before or after injection) magnesium potassium,kidney issues ( proteinuria) elevated white blood count left hip prosthetic in failure edema in left lower leg and foot,"left hip has had 4 major surgeries was in stage four kidney failure in november and december, spent 34 days in hospital",,sulfa,"['Balance disorder', 'Joint swelling', 'Musculoskeletal disorder', 'Pain', 'Tendon pain', 'Weight bearing difficulty']",UNK,MODERNA,IM 1060751,TN,40.0,M,"Heart attack. Chest pain and numbness in both arms and back. The pain lasted from 3:00AM until 5:00AM at which time I as in the ER. Troponin levels were at 6.0 and I had a small abnormal finding on my EKG. The Cardiovascular physician on call said it could be something and they would do a cardiac cath to determine where a blockage may be. The angiogram cam back with no blockages. troponin levels reached a 10 by the end of the first day. The Echo the next day showed no issues in structure. The Cardiac MRI showed fluid and 4% of my heart had myocarditis from the issue. Troponin levels reduced to 7, then 6 by the end of the second day. On the third day I went home with new meds, an order for a follow up and cardiac rehab.",Not Reported,,Not Reported,Yes,3.0,Yes,U,02/05/2021,02/08/2021,3.0,PVT,"Claritin D, Multivitamin",None,None,,None,"['Angiocardiogram', 'Chest X-ray', 'Chest pain', 'Electrocardiogram', 'Hypoaesthesia', 'Magnetic resonance imaging heart', 'Myocardial infarction', 'Myocarditis', 'Troponin increased']",2,PFIZER\BIONTECH,IM 1060777,,77.0,M,unknown if Moderna or Pfizer. Altered mental status that increased and led to hospitalization.,Not Reported,,Not Reported,Yes,,Not Reported,N,02/23/2021,02/24/2021,1.0,UNK,,,"COPD, HTN",,,['Mental status changes'],2,MODERNA, 1060820,KY,78.0,F,RECEIVED FIRST DOSE OF PFIZER COVID 19 VACCINE ON 02/26/21. WENT TO ER ON 02/27/21 COMPLAINING OF HEMATEMESIS AND BLOCK COLORED STOOL. ANTICOAGULATED ON ASPIRIN AND PLAVIX. DIAGNOSED WITH UPPER GI BLEED AND ADMITTED TO HOSPITAL ON 02/27/21.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/26/2021,02/27/2021,1.0,PVT,,,,,STATINS TETANUS TOXOIDS NORVASC,"['Blood creatinine increased', 'Blood urea', 'Blood urea increased', 'Brain natriuretic peptide', 'Faeces discoloured', 'Haematemesis', 'Haematocrit', 'Haemoglobin', 'Red blood cell count', 'Troponin', 'Upper gastrointestinal haemorrhage', 'Urine analysis abnormal']",1,PFIZER\BIONTECH,IM 1060833,NC,74.0,F,"Severe headache, nausea and vomiting",Yes,02/25/2021,Not Reported,Not Reported,,Not Reported,N,02/24/2021,02/25/2021,1.0,PHM,,,,,,"['Death', 'Headache', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH,IM 1060841,NJ,68.0,F,Became dizzy two weeks after the first vaccine and continue to be dizzy two weeks after the second. Spent 24 hours in the hospital and could not find anything reason for it. Had cat scans and MRI. Went to an ENT and still cannot find out why I am still dizzy.,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/28/2021,02/02/2021,5.0,PUB,Synthroid Pravochol Lexapro Modafinil Vitamin D3,,Fibromyalgia Hypothyroid,,Codeine Percocet phenobarbital,"['Acoustic stimulation tests', 'Blood test', 'Computerised tomogram', 'Dizziness', 'Magnetic resonance imaging', 'Scan with contrast']",2,PFIZER\BIONTECH,SYR 1060856,KY,70.0,M,RECEIVED 1ST DOSE OF PFIZER COVID19 VACCINE ON 02/13/21. ON 02/26/21 WENT TO ER WITH COMPLAINT OF CHEST TIGHTNESS AND PAIN IN HIS BACK. HAD ABNORMAL EKG AND ADMITTED TO HOSPITAL WITH DIAGNOSIS OF CHEST PAIN AND ABNORMAL EKG.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/13/2021,02/26/2021,13.0,PVT,,DYE (IODINATED DIAGNOSTIC AGENTS) INFLUENZA VIRUS VACCINE H5N1 ZITHROMAX,,HIVES AFTER INFLUENZA VIRUS VACCINE H51N1 11/2019,,"['Back pain', 'Chest discomfort', 'Chest pain', 'Electrocardiogram abnormal']",1,PFIZER\BIONTECH,IM 1060858,TX,61.0,M,"had lack of appetite before second dose. When received the second dose, he started vomiting on the way home. Was sick on and off for the next few days. Died suddenly on 2/23/2021",Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,UNK,"Nifedipine, Klor-con, HCTZ",Hypertension,Hypertension,,,"['Autopsy', 'Death', 'Decreased appetite', 'Sudden death', 'Vomiting']",2,UNKNOWN MANUFACTURER, 1060879,FL,79.0,F,stroke spent 3 days in ICU and saw a neurologist,Not Reported,,Yes,Yes,3.0,Yes,Y,01/31/2021,01/31/2021,0.0,PHM,losartan amlodipine multivitamin coq10 turmeric something for cholesterol,,high cholesterol high blood pressure,,none,"['Blood test', 'Cerebrovascular accident', 'Computerised tomogram', 'Intensive care']",1,MODERNA,IM 1060901,PA,63.0,M,"Cardiac arrest just stopped breathing fortunately at home wife called 911 within five minutes of noticing not breathing responders there in 3-5 minutes worked on him for 15 minutes at home before transporting to ER hospital. No heart beat pulse etc... used CPR machines and paddles Patient had walked 6 1/2 miles that morning no problems did about 50-60 miles weekly outside. This was sudden and me, his wife, say it was a reaction to something in shot that contributed to this event- there is absolutely nothing you could say to make believe differently. This happened 1 1/2 hours after getting shot.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,02/23/2021,02/23/2021,0.0,PHM,Rosuvastatin .5 mg. Metoprolol succinate 25 mg. Metformin HCL ER 500 mg aspirin 81 mg. Curamed / curcumin alpha lipoid sustain sucontral D French grape seed extract VX1 mega CoQ10 Mushroom complex for immunity and jadegreenzymes a pure f,None,Blood pressure and diabetes controlled by drugs 2009 heart cath did not require stents handled well by drugs since then improved and removed some of the plaque etc...,,None,"['Cardiac arrest', 'Coronary arterial stent insertion', 'Coronary artery occlusion', 'Pulse absent', 'Respiratory arrest', 'Resuscitation', 'Stent placement']",1,MODERNA,SYR 1060949,MA,88.0,M,"Starting on Saturday, 2/6/2020, four days after vaccine, elevated heart rate, 160 bpm and low blood sugar. Before the vaccine, there was no problem with my heart rate. Now, I am taking Labeatol 4 times a day to keep rate at least at 90. This vaccine has doubled my heart rate. It was 70 before the vaccine. Now if I do not take my Labetalol, it goes up to 140. Because my body is working so hard with that heart rate, it is making my sugar low. So now I'm taking less insulin and this whole situation is getting confusing on how to handle this long term, adverse reaction to the Pfizer vaccine.",Not Reported,,Yes,Not Reported,,Yes,N,02/02/2021,02/06/2021,4.0,PUB,"Prescriptions: Labetalol 100 mg 2x Lisinporil 20 mg 1x + 10mg 1x Meformin: 500 mg 2x Dutasteride: 0.5 mg 1x Insluin: Levemir Flex Touch 40 units am, 45 units PM SUPPLEMENTS COq10, Omega 3, Lipoic Acid, Glucose Essentials, Vision Essentials,",None,"Diabetic, insulin twice a day. High blood pressure, high chloesterol, vision problems AND NOW AN ELEVATED HEART RATE",,none,"['Blood glucose decreased', 'Electrocardiogram abnormal', 'Heart rate increased', 'Supraventricular tachycardia']",UNK,PFIZER\BIONTECH, 1060950,KY,72.0,U,"RECEIVED BOTH PFIZER COVID VACCINES ON 01/27/21 & 02/14/21. WENT TO ER ON 02/28/21 WITH COMPLAINT OF URINARY FREQUENCY, ALTERED MENTAL STATUS, AND FATIGUE. DIAGNOSED WITH ALTERED MENTAL STATUS, UNSPECIFIED ALTERED MENTAL STATUS, ACUTE UTI, TACHYCARDIA, AND SINUSITIS. ADMITTED TO HOSPITAL.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/14/2021,02/28/2021,14.0,PVT,,,,,ROSUVASTATIN,"['Fatigue', 'Mental status changes', 'Pollakiuria', 'Sinusitis', 'Tachycardia', 'Urinary tract infection']",1,PFIZER\BIONTECH,IM 1061059,CA,77.0,F,Do not know if patient informed her physician that she received vaccine on 1/29/2021. She had appt at 3:15 pm on 1/29 and afterwards stated she received the Moderna vaccine. Reporter is uncertain if this was at a health office or clinic. She drove herself to the ER at about 3am on 1/30/2021 with increased cramping and pain.,Yes,01/31/2021,Not Reported,Yes,2.0,Not Reported,N,01/29/2021,01/30/2021,1.0,OTH,Not known to reporter,Was undergoing diagnostic testing for gastrointestinal complaints of several weeks duration. Had CT morning of 1/29/2021.,History of type 2 diabetes Hip replacement had been postponed due to pandemic,,not known to reporter,"['Computerised tomogram abdomen', 'Death', 'Muscle spasms', 'Pain']",1,MODERNA, 1061064,SD,85.0,F,Unable to breathe and died. Doctors unable to save her upon arrival,Yes,02/27/2021,Not Reported,Not Reported,,Not Reported,N,02/26/2021,02/27/2021,1.0,OTH,Sulfamethoxazole and Trimethoprim Tablets Oxy Antidepressants Anxiety meds Bladder control,Bacterial infection,"Depression, anxiety, and pain in joints from arthritis",,,"['Death', 'Respiratory arrest']",2,PFIZER\BIONTECH,SYR 1061077,CO,86.0,F,"Day after second dose decedent had fever and tremors, subsided on day three (less than 72 hours) after dose with exterem wekness followed by death less than 72 hours after second dose",Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,02/25/2021,02/26/2021,1.0,OTH,"Oxygen 6L, furosemide, tylenol, gabapentin, aspirin, hydralazine, glucosamine, mirtazapine, Repatha, procrit, multivitamin",None,"pulmonary fibrosis, coronary artery disease, hypertension, hyperlipidemia, CKD",,Unknown,"['Asthenia', 'Death', 'Pyrexia', 'Tremor']",UNK,MODERNA, 1061096,MA,25.0,F,Seizure after vaccine overnight. Patient has a history of seizures.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/21/2021,02/21/2021,0.0,SEN,,,,,,['Seizure'],2,PFIZER\BIONTECH,IM 1061117,MO,86.0,M,multiple system organ failure 4 days after receiving COVID vaccine.,Not Reported,,Yes,Yes,,Not Reported,N,02/20/2021,02/24/2021,4.0,PVT,oxycodone,,"cad, chronic kidney disease, copd, chf",,"gabapentin, metoclopramide, primidone","['Blood creatinine', 'Brain natriuretic peptide', 'Brain natriuretic peptide increased', 'COVID-19 immunisation', 'Chest X-ray', 'Multiple organ dysfunction syndrome', 'Pulmonary oedema', 'Troponin increased']",UNK,PFIZER\BIONTECH,SYR 1061160,PA,20.0,M,Possible adverse effect Pneumonia.,Not Reported,,Not Reported,Yes,7.0,Not Reported,N,02/19/2021,02/22/2021,3.0,UNK,Keppra. Vimpat. Onfi. Epidiolex. Imuran. Prevacid,None,Pfeiffer syndrome Seizures Sleep apnea,,Tegretol,"['Chest X-ray', 'Full blood count', 'Pneumonia']",UNK,MODERNA,SYR 1061173,KY,84.0,F,RECEIVED PFIZER COVID VACCINE 1ST DOSE ON 02/13/21. WENT TO ER ON 02/28/21 WITH COMPLAINT OF BRADYCARDIA AND FELT FAINT. DIAGNOSED WITH SYNCOPE AND COLLAPSE AND ABCESS OF LOWER LEFT LUNG WITH PNEUMONIA. ADMITTED TO HOSPITAL.,Not Reported,,Not Reported,Yes,,Not Reported,,02/13/2021,02/28/2021,15.0,PVT,,,,,,"['Bradycardia', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram pelvis abnormal', 'Dizziness', 'Lung abscess', 'Pneumonia', 'Scan with contrast abnormal', 'Syncope']",1,PFIZER\BIONTECH,IM 1061182,NM,19.0,F,"SWELLING AND SECONDARY BACTERIAL INFECTION OF RIGHT ARM WITHIN WEEK OF ADMINISTRATION; TREATED SUCCESSFULLY WITH CIPROFLOXACIN AT EMERGENCY ROOM. WITHIN 1 WEEK OF RECEIVING VACCINE, PT NOTICED INCREASED WORK OF BREATHING AND PROCURED ALBUTEROL INHALER AFTER SEVERAL YEARS OF NO ASTHMA SYMPTOMS. SYMPTOMS WORSENED DAILY. SHE WAS SEEN @ CLINIC 02/13/2021 WITH ACUTE ASTHMA EXACERBATION: RX'D QVAR 80, ALBUTEROL NEBULIZER, SHORT-COURSE PREDNISONE, AND SINGULAIR. 02/14/21: ADMITTED TO HOSPITAL FOR WORSENING SYMPTOMS RELEASED AMA THE NEXT DAY. 02/20/21: URGENT CARE VISIT FOR WORSENING SYMPTOMS. RX FOR IPRATROPRIUM INHALER AND ZPACK 02/23/21: HOSPITAL ED FOR WORSENING SYMPTOMS; NOT ADMITTED",Not Reported,,Yes,Yes,1.0,Not Reported,N,01/13/2021,01/13/2021,0.0,PHM,SERTRALINE 100MG TRAZODONE 50MG BUPROPRION 300MG,NONE,"MILD INTERMITTENT ASTHMA, NO ALBUTEROL USE IN SEVERAL YEARS",,PENILLICILLINS,"['Asthma', 'Bacterial infection', 'Blood test normal', 'Chest X-ray abnormal', 'Computerised tomogram thorax normal', 'Condition aggravated', 'Dyspnoea', 'Peripheral swelling']",1,MODERNA,IM 1061184,CA,70.0,M,"Possible heart attack on 2/5/21. Complaint: "" On Feb 5th l believe l experienced a mild hear attack"" (Comment: He said he felt ""clammy, sweaty, excruciating pain on my left side - including his left arm, and left leg, dizzy, exhausted."" This happened after work, and after taking a shower. He said that was the first time he's experienced it, and that it has not happened since then. He said he has constant headaches, ""It just went away yesterday.""",Yes,02/25/2021,Yes,Not Reported,,Not Reported,N,01/14/2021,02/05/2021,22.0,OTH,ASA Atorvastatin Lisinopril,none,Hyperlipidimia Hypertension,,NKDA,"['Cold sweat', 'Dizziness', 'Echocardiogram', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Myocardial infarction', 'Pain', 'Pain in extremity']",1,MODERNA,IM 1061226,MI,74.0,F,death,Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/06/2021,5.0,SEN,,progressive supra nuclear palsy,PSP HTN,,penicillin,['Death'],2,UNKNOWN MANUFACTURER,SYR 1061228,CT,89.0,F,"I learned that my mother started feeling ill the day after the shot in the evening and then went to bed. On Saturday, January 23rd, she was exhausted and unable to get up. We learned this from a friend of hers who had called us back after both my brother and I were unable to reach her by phone. This was about 3:15 pm and we drove to her apartment and found her semi conscious in her bed. We awoke her but she was unable to talk or get up. We then called 911 and emergency paramedics came and took her to hospital.",Not Reported,,Yes,Yes,20.0,Not Reported,N,01/21/2021,01/23/2021,2.0,PUB,"Simvistatin, Lopressor, Vitamin B12, Iron",,"Thrombocytopenia, Anemia",,None,"['Aphasia', 'Depressed level of consciousness', 'Fatigue', 'Malaise', 'Mobility decreased']",1,MODERNA,IM 1061233,CA,64.0,F,"With in seconds of receiving vaccine had seizure like effect in head resulting in out of body like experience, muffled hearing, a foul taste in my mouth and altered state of eurphoria. Could not report symptoms but if had been asked directly could have. REalised half way driving home that I should not be driving. Eurphoria lasted for 24 hours. Was on phone constantly the next day for 7 hours straight without eating. Could not remember what some items were like a drone. Had to ask = that thing that flies with a camera. Short term memory loss that continues. Facial numbness began 48 hours after injection. Facial numbness continues changing in areas of right side of my face. Felt extremely vulnerable. Wore my same clothing for 4 days as I did not remember that I had clean clothing. Did not remember that I should notify medical personal until late 2/20.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/18/2021,02/18/2021,0.0,OTH,"levothyroxine, amlodipine besylate,",sore throat 3 weeks prior,blood pressure,,sulpha sensitivity,"['Amnesia', 'Autoscopy', 'Blood test normal', 'Computerised tomogram normal', 'Decreased appetite', 'Euphoric mood', 'Hypoacusis', 'Hypoaesthesia', 'Magnetic resonance imaging normal', 'Seizure like phenomena', 'Taste disorder']",2,PFIZER\BIONTECH,IM 1061270,IL,63.0,F,Individual received her COVID vaccine and had no prior symptoms. 24 hours after the injection she developed significant shortness of breath and was seen in the ER where she was diagnosed with bilateral pulmonary embolism.,Not Reported,,Not Reported,Yes,,Not Reported,N,02/12/2021,02/13/2021,1.0,WRK,"Aspirin, Kevzara, Myrbetric, Pramipexole, Spirava, Symbicort,",None,"Hx of PE in 2014 (due to travel), Rheumatoid Arthritis, Hypertension, Mild COPD, RLS",,"Sulfa, Methotraxate, Humira,Hydrozychloroquine","['Dyspnoea', 'Pulmonary embolism']",2,MODERNA,IM 1061303,CA,78.0,F,Death. Patient was found unresponsive in the morning hours after her shot.,Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/21/2021,20.0,PUB,Atorvastatin,,Pace maker,,,"['Death', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,SYR 1061313,CA,37.0,M,"Major gout flare up on right knee, and right big toe.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/25/2021,02/26/2021,1.0,PHM,Alopurnal prescription Omeprazol,Gout,Gout,,None,"['Condition aggravated', 'Gout']",1,MODERNA,SYR 1061355,WA,70.0,F,"within 1 hour started throwing up, continued for the next 12 hrs. Blood Sugar went to 700 and would not come down with long term and short term insulin. called 911, taken to Hospital ER. on feb. 27 @ 8:00 am Admitted and still is in ICU today 2-28-2021.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/26/2021,02/26/2021,0.0,UNK,"lisienpril, hydrochlorthiazide, potassium,","diabetes, high blood pressure, basal ganglia stroke","Diabetes, stroke, high blood pressure",,none,"['Blood glucose increased', 'Blood test', 'Computerised tomogram normal', 'Electrocardiogram', 'Intensive care', 'Vomiting']",1,PFIZER\BIONTECH,IM 1061358,HI,74.0,M,Pericarditis with pericardial effusion.,Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/25/2021,02/15/2021,21.0,PVT,"Valsartan, ursadiol, citalopram, Montalukast, ASA, Ativan, tamsulosin, fluticasone",,"HTN, Primary Biliary Cirrhosis",,NKA,"['Antinuclear antibody', 'C-reactive protein', 'Echocardiogram', 'Electrocardiogram', 'Full blood count', 'Metabolic function test', 'Pericardial effusion', 'Pericarditis', 'Polymerase chain reaction', 'Respiratory viral panel', 'Streptococcus test']",UNK,MODERNA,IM 1061373,TX,59.0,F,"Patient had gradual onset of urinary retention and a mix of upper/lower motor neuron dysfunction. Currently going under workup for acute demyelinating polyneuropathy. Currently admitted to Medical Center, receiving Solumedrol, undergoing plasma exchange.",Not Reported,,Not Reported,Yes,5.0,Yes,N,01/28/2021,02/19/2021,22.0,MIL,Flonase 1 spray into each nostril daily as needed Cetirizine 10 mg 1 tablet by mouth daily Fenofibrate 160 mg 1 tablet by mouth nightly Montelukast 10 mg 1 tablet by mouth daily Aspirin 81 mg 1 tablet by mouth daily Magnesium OTC Probiotic,None,"Seasonal allergies High cholesterol Microadenoma pitiutary, 2014 Hashimotos Thyroiditis Diverticulosis wirth recent flare up June 2020.",,NKDA,"['Demyelinating polyneuropathy', 'Laboratory test', 'Motor neurone disease', 'Plasmapheresis', 'Urinary retention']",UNK,PFIZER\BIONTECH, 1061374,MA,84.0,M,"Severe Vertigo lasting 12 hours requiring confinement to bed. Called ambulance and taken to Emergency Room. Treated with fluids and meclazine. Vertigo attributed to Vestibular Neuritis/labyrinthitis. This condition is often caused by a virus, however patient did not have any known virus prior to onset of symptoms.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/05/2021,02/25/2021,20.0,PVT,Simvistatin 40 mg and 20 mg Mirtazipine 45 mg Levothyroxine 150 mcg Valsartan and hydrochlorothiazide 80 mg/12.5mg Venlafaxin hcl 25 mg Lamotrigne 100 mg Tamsulosin hcl .4 mg,,Depression- controlled,,Cephalexin,"['Bedridden', 'Computerised tomogram head', 'Labyrinthitis', 'Magnetic resonance imaging brain', 'Neuritis', 'Vertigo', 'Vestibular neuronitis']",1,MODERNA,IM 1061380,IA,76.0,F,"Received the vaccine & the next day became very weak and ill with throwing up. Her sister came to visit and noticed her right face was drooping & her balance was off so she called ambulance. Subsequently has been hospitalized for a month with a heart failure exacerbation that has led to ICU care, sepsis with Klebsiella pneumonia, acute kidney injury now with long term dialysis, hyponatremia, & elevated liver enzymes",Not Reported,,Not Reported,Yes,20.0,Yes,Y,01/22/2021,01/22/2021,0.0,PVT,"aspirin, atorvastatin, calcium, vit. D, diltiazem, doxycycline hyclate, Jardiance, furosemide, gabapentin, novolog, lantus, levothyroxine, magnesium oxide, potassium chloride, spironolactone, warfarin","Had Covid October 2020 with only symptoms reported being weakness. Had a small stroke with no residual effects at the time, unsure if related to Covid.","hypertension, a prior stroke, type II diabetes mellitus, hyperlipidemia, congestive heart failure, and atrial fibrillation on warfarin",,"ciprofloxacin, hydrocodone, indomethacin, levofloxacin, menthol, methyl salicylate, morphine, plastic tape, penicillin, vancomycin","['Acute kidney injury', 'Asthenia', 'Atrial fibrillation', 'Balance disorder', 'Cardiac failure', 'Condition aggravated', 'Dialysis', 'Facial paralysis', 'Hepatic enzyme increased', 'Hyponatraemia', 'Intensive care', 'Malaise', 'Pneumonia klebsiella', 'Sepsis', 'Vomiting']",1,PFIZER\BIONTECH,IM 1061434,MN,97.0,F,"I am the patient's daughter as well as an RN-BSN. My mother was given the Moderna vaccine on Feb 11, 2021 and on Feb 15, 2021 she had a CVA and MI. She was found on her apt. floor unconscious. She was transferred to the Hospital by ambulance where a CT scan and other tests were done. It was determined she had a stroke and heart attack. My mother was in great health, took no medications, and lived alone in her apt. before this incident. The medical professionals determined she would not recover so she was admitted to hospice and died on Feb. 21, 2021. I believe there is a relationship between the vaccine and the CVA and MI.",Yes,02/21/2021,Not Reported,Yes,6.0,Not Reported,N,02/11/2021,02/15/2021,4.0,PVT,None,None,None,,None,"['Cerebrovascular accident', 'Computerised tomogram abnormal', 'Death', 'Loss of consciousness', 'Myocardial infarction']",1,MODERNA,IM 1061457,GA,61.0,F,"cold symptoms, headache, sore arm, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/28/2021,02/28/2021,0.0,PHM,"metphormin, januvia, steglatro, vitamin D3, zinc,",diabetes,diabetes,,codeine,"['Fatigue', 'Headache', 'Nasopharyngitis', 'Pain in extremity']",1,PFIZER\BIONTECH,SYR 1061608,MD,77.0,F,"The patient had her second Moderna shot on Feb 17, 2021. At 3 am the next morning she reported to the ED c/o being ""fluish"" and short of breath. She was found to be hypoxic to the upper 80's on RA, and a CXR was consistent with CHF. She stated she had some off and on chest pain for the last few weeks, especially with exertion. Ultimately it was found that she had an elevated troponin and was felt to have had an MI. She underwent cardiac cath and a stent was placed in a 95% ostial right coronary stenosis. Although she was reported as having had a ""hyperimmune"" response to the vaccine, I can only say for certain she had flash pulmonary edema due to cardiac ischemia that was due to a stenosis in her RCA that had been there for quite some time, but possibly just happened to become critical right after her second COVID vaccine. It would be hard to blame the vaccine, but it is also impossible I guess to absolve it from any role in her MI.",Not Reported,,Not Reported,Yes,6.0,Not Reported,U,02/17/2021,02/18/2021,1.0,UNK,,,,,,"['Acute pulmonary oedema', 'Cardiac failure congestive', 'Catheterisation cardiac', 'Chest X-ray abnormal', 'Chest pain', 'Coronary artery stenosis', 'Dyspnoea', 'Hypoxia', 'Influenza like illness', 'Myocardial infarction', 'Myocardial ischaemia', 'Stent placement', 'Troponin increased']",2,MODERNA,IM 1061637,CA,30.0,F,1/1/21- Severe right side eye pain 1/3/21 - Appearance of vesicular rash with sever pain above right eyelid 1/3/21 - Diagnosed with Zoster Ophthalmicus of Right Eye at urgent care and initiated on Valacyclovir 1000 mg PO TID x 10 days 1/4/21 - Ganciclovir eye drops added to treatment course 1/10/21- Rash crusted and resolved but with severe neuropathic pain and itch 1/12/21 - Second dose of COVID vaccine received,Not Reported,,Not Reported,Not Reported,,Yes,Y,12/17/2020,01/03/2021,17.0,PVT,Multivitamins,None,Mixed connective tissue disease,,No Known Allergies,"['Eye pain', 'Eyelid pain', 'Neuralgia', 'Ophthalmic herpes zoster', 'Pruritus', 'Rash vesicular', 'Scab']",1,PFIZER\BIONTECH,IM 1063174,,85.0,M,"Narrative: Patient received COVID/Pfizer #1 2/10/21 in L deltoid. (Patient home bound). On 2/12/21 reported left flank rash. 2/13 rash spread to entire abdomen/chest and UEs. Continued with fluctuations in BP/HR, fluid retention. On 2/16 labs ordered and Medrol dose pack. seen in home on 2/19 by MD - RUE swelling; diffuse rash over entire body; additional labs ordered (order to home infusion company). Patient passed in AM of 2/20/21. Reported no urine output the prior evening. Additional labs not performed due to death of patient prior to lab company arrival.",Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/12/2021,2.0,OTH,,,,,,"['Alanine aminotransferase', 'Anion gap', 'Aspartate aminotransferase', 'Band neutrophil percentage', 'Basophil count', 'Basophil percentage', 'Blood albumin', 'Blood alkaline phosphatase', 'Blood bilirubin', 'Blood calcium', 'Blood chloride', 'Blood creatinine', 'Blood glucose', 'Blood potassium', 'Blood pressure fluctuation', 'Blood sodium', 'Blood thyroid stimulating hormone', 'Blood urea', 'Carbon dioxide', 'Death', 'EGFR gene mutation', 'Eosinophil count', 'Eosinophil percentage', 'Fluid retention', 'Free thyroxine index', 'Full blood count', 'Haematocrit', 'Haemoglobin', 'Heart rate irregular', 'Hypochromasia', 'Injection site rash', 'Laboratory test', 'Lymphocyte count', 'Lymphocyte percentage', 'Mean cell haemoglobin', 'Mean cell haemoglobin concentration', 'Mean cell volume', 'Monocyte count', 'Monocyte percentage', 'Neutrophil count', 'Neutrophil percentage', 'Peripheral swelling', 'Platelet count', 'Polychromasia', 'Protein total', 'Rash', 'Red blood cell analysis', 'Red blood cell burr cells present', 'Red blood cell count', 'Red blood cell microcytes', 'Red cell distribution width', 'Thyroid function test', 'Tri-iodothyronine', 'Urine output decreased', 'White blood cell count']",1,PFIZER\BIONTECH,IM 1061650,PA,48.0,F,15 minutes after 2nd vaccine developed urticaria. 30 minutes after vaccine chest tightness and coughing. Brought to the ER and treated with IV Benadryl. Felt better but abnormal EKG so kept over night.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/27/2021,01/27/2021,0.0,PVT,,,,,,"['Chest discomfort', 'Cough', 'Electrocardiogram abnormal', 'Urticaria']",2,MODERNA,IM 1061676,TX,32.0,M,"Developed severe lethargy, chills, fatigue. After feeling this way, 1-2 weeks later, I got labs which indicated severe AKI and I was hospitalized for 30 hours and given fluids. Fortunately, I have near resolution of kidney function at this time.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/23/2020,12/24/2020,1.0,PHM,None,None,None,,None,"['Acute kidney injury', 'Chills', 'Fatigue', 'Glomerular filtration rate decreased', 'Lethargy', 'Metabolic function test']",UNK,MODERNA,IM 1061684,OH,69.0,M,"Diagnosed with painful case of gout. First time in life. Prescribed prednisone for 1 week and pain gone, swelling mostly gone as of 2/26. But on 2/28 gout returned and very painful/",Not Reported,,Not Reported,Not Reported,,Yes,N,02/16/2021,02/22/2021,6.0,PHM,"levoxyl, simvastatin, metopropol,hydrochlorothiazide,omeprazole,doxycycline,enteric aspirin, probiotic, zinc/vitamin d3",none,"thyroidectomy, hypertension, overweight, cholestrol",,Allergies to pollens,"['Blood uric acid increased', 'Gout', 'Pain']",UNK,MODERNA,IM 1061869,PR,46.0,F,"headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; This is a spontaneous report from a contactable Consumer (patient). A 46-years-old female patient received bnt162b2 (BNT162B2, Lot number: EM5318) second dose, via an unspecified route of administration on 28Jan2021 at left arm at SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Sulfa from an unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 on 08Jan2021 (vaccine location=Left arm; lot number=EK41, administration time=01:45 PM). Concomitant medication included levothyroxine sodium (SYNTHROID), calcium (CALCIUM), hibiscus tea and green tea. The patient experienced headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back on 28Jan2021 16:00 with outcome of recovering. No treatment received for events. No covid prior vaccination. No covid tested post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,UNK,SYNTHROID; CALCIUM,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,"['Headache', 'Lymphadenopathy', 'Myalgia', 'Pyrexia', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1061901,NM,59.0,F,"First dose administered 21 days before; Headaches; Nausea; Fever; Body aches; Chills; Joint pain; Throwing up; Extreme exhaustion; A spontaneous report was received from a pharmacist concerning a 59 years old female patient who received Modern's COVID-19 vaccine (mRNA-1273) who experienced headaches, nausea, fever, body aches, chills, joint pain, throwing up, extreme exhaustion, and inappropriate schedule of vaccine administration. The patients medical history was not provided. Concomitant medication included vitamins and female hormones. On 25 Jan 2021 prior to the onset of the events, the patient received their second dose of mRNA-1273 (lot/batch: 025520-2A) for prophylaxis of COVID-19 infection. First dose might have been administered 21 days before. On 25 Feb 2021, after 12 hours of receiving the vaccine, the patient experienced headaches nausea, fever, chills, joint pain, throwing up, extreme exhaustion. No Laboratory details provided. Treatment for the events include paracetamol and antibiotics. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, headaches, nausea, fever, body aches, chills, joint pain, throwing up, extreme exhaustion, were not reported. The outcome of the event, inappropriate schedule of vaccine administration, was resolved on 25 Jan 2021.; Reporter's Comments: This case concerns a 59 Y/O F who had a nonserious unexpected event of Inappropriate schedule of product administration with mRNA-1273 (lot # 025520-2A) with nonserious expected fatigue, fever, chills, nausea, vomiting, headache, pain, arthralgia. Event onset the same day as the second dose, which was 21 days after the first dose. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,UNK,VITAMINS NOS,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Inappropriate schedule of product administration', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",2,MODERNA,OT 1061902,,,U,"Angioedema both times; A spontaneous report was received from a health care provider concerning a patient (him/herself), age and gender not reported, who experienced angioedema. The patient's medical history was not reported. Concomitant product use was not provided by reporter. On unknown date, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. Per voicemail, an adverse event was reported on both the first and second dose of Moderna vaccine. Angioedema both times, the second time was a little bit worse. The second dose lasted three days. Treatment for the event included prednisolone, famotidine, and diphenhydramine. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The outcome for the event was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Treatment for the event included prednisolone, famotidine, and diphenhydramine. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Angioedema'],2,MODERNA,OT 1061903,,,F,"Allergic Reaction, tongue swelled; Allergic reaction; A spontaneous report was received by a consumer concerning a 20-30-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced allergic reaction, tongue swelled (swollen tongue). The patient's medical history was not provided by the reporter. Concomitant product use was unknown. On an unknown date, prior to the onset of the events, the patient received a dose of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection. The reporter stated that on 23 Jan 2021 at 5:30 PM he was informed that his friends fiance had an allergic reaction shortly after receiving a dose of Moderna's vaccine (mRNA-1273). The patient's tongue swelled, and an EpiPen was administered. The patient was then taken to the emergency room (ER) for monitoring. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, allergic reaction, tongue swelled, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Hypersensitivity', 'Swollen tongue']",1,MODERNA,OT 1061904,SC,,M,"progressively worsening symptoms of COPD; A spontaneous report was received from a consumer who was also a male patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced progressively worsening symptoms of chronic obstructive pulmonary disease (COPD)/COPD exacerbation. The patient's medical history included COPD, which the patient admitted was worsening before the vaccine. Relevant concomitant medications included simvastatin, lisinopril, and allopurinol. On 04 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient was hospitalized for progressively worsening symptoms of his COPD. Treatment included a prednisone injection in the hospital and prednisone 60 mg orally after discharge from the hospital (date unknown) for more than a week. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event progressively worsening symptoms of COPD was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/04/2021,02/11/2021,7.0,UNK,SIMVASTATIN; LISINOPRIL; ALLOPURINOL,COPD (Patient reported COPD was worsening before the vaccine),,,,['Chronic obstructive pulmonary disease'],1,MODERNA,OT 1061905,UT,,M,"light headed, caused him to pass out; dizzy; A spontaneous report was received from a consumer concerning, a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced light headed caused him to pass out and dizzy. The patient's medical history was not provided. No relevant concomitant medications were reported. On 13 Jan 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. It was also reported that after receiving his first dose, the patient reported symptoms of fatigue, headache and chills. On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. After receiving the second dose, the patient reported feeling dizzy and lightheaded when he woke up the next morning. He then passed out and hit his head. No treatment information was provided. Action taken with study drug was not applicable as the subject had already received both scheduled doses The outcome of the events, light headed caused him to pass out and dizzy were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reporter.),,,"['Dizziness', 'Loss of consciousness']",2,MODERNA, 1061906,CA,37.0,M,"Atrial fibrillation; Hard to breathe; A spontaneous report was received from a consumer (patient's wife), regarding a 37 years-old white male patient, unknown ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced, atrial fibrillation, uncomfortable (discomfort), and hard to breathe (dyspnoea). Current medical conditions reported as controlled atrial fibrillation and cardiomyopathy. Past medical history includes atrial fibrillation diagnosis (May 2018) and stroke (May2018/hospitalized). Weight reported as 180 lbs.The patient's medication allergy included albuterol inhaler. Concomitant medications reported included are rivaroxaban, levetiracetam, bisoprolol and flecainide. On 15 JAN 2021, one day prior to the onset of events, the patient received their first of planned doses of mRNA-1273 (batch number: 029L20A), at a dose of 0.5 ml, intramuscular in the left arm for the prophylaxis of COVID-19 infection. The consumer reported that the patient became uncomfortable and it was hard to breathe on 16 JAN 2021. On 17 JAN 2021, in the morning, the patient went into atrial fibrillation. The patient received treatment medication with a double dose of flecainide and went back into normal sinus rhythm about 2 hours later. On 18 JAN 2021, in the morning, the patient had a second occurrence of atrial fibrillation, for which he received treatment with a double dose of flecainide and went back into normal sinus rhythm. On 21 JAN 2021, the patient again developed atrial fibrillation third occurrence, for which he received treatment with a double dose of flecainide and went back into normal sinus rhythm. On 27 JAN 2021, the patient had a fourth occurrence of atrial fibrillation, for which he received treatment with a double dose of flecainide and went back into normal sinus rhythm. These adverse events were reported to his physician. The consumer stated that she can be further contacted if the safety department follows up for any additional information. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of the events, atrial fibrillation, uncomfortable, and hard to breathe, were reported as not recovered.; Reporter's Comments: Very limited information regarding this event has been provided at this time. The patient's medical history of atrial fibrillation and cardiomyopathy remains a confounding factor. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/16/2021,1.0,UNK,XARELTO; KEPPRA; BISOPROLOL; FLECAINIDE,Atrial fibrillation; Cardiomyopathy; Drug allergy (Allergies include albuterol inhaler),Medical History/Concurrent Conditions: Stroke (Hospitalized),,,"['Atrial fibrillation', 'Dyspnoea']",1,MODERNA,OT 1061907,FL,75.0,M,"Double vision; Chills; Low graded fever (99.8); A spontaneous report was received from a consumer, concerning a 75-year-old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced double vision, chills and low graded fever (99.8). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 30 JAN 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number 012M20A) intramuscularly for prophylaxis of COVID-19 infection. On 31JAN2021, after the vaccine administration, the patient developed chills and low-grade fever of 99.8, hence he was given with acetaminophen to alleviate these symptoms. On 01 FEB 2021, the patient started experiencing double vision, hence, on 05 FEB 2021, the patient went to their eye doctor who instructed the patient to go to the emergency room (ER). The ER doctor admitted the patient to the hospital to run some tests and labs. The patient was tested for stroke, tumor, and bell palsy and all these tests were negative. The hospital conducted several CT and MRI and they were all negative. The neurologists did not know what was going on with the patient. Hence, he was discharged from the hospital on 07 FEB 2021. The patient was still having symptoms. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not applicable. The outcome of the events double vision, chills and low graded fever (99.8) were considered not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/30/2021,01/31/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,"['Chills', 'Computerised tomogram', 'Diplopia', 'Magnetic resonance imaging', 'Pyrexia']",2,MODERNA,OT 1061908,TX,52.0,M,"Fainting twice; Low blood pressure; Sweating like hell; Dizziness; Significant chill; Body was feeling hot; A spontaneous report was received from a consumer, a 52 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine, who experienced fainting twice (syncope), low blood pressure (hypotension), sweating like hell (hyperhidrosis), dizziness, significant chills (chill), and body was feeling hot (pyrexia). The patient's current conditions included epilepsy and slight cholesterol. Historical condition was not reported. Products known to have been used by the patient, within two weeks prior to the event, included eslicarbazepine acetate, simvastatin, atorvastatin, sertraline hydrochloride, acetylsalicylic acid, ubidecarenone, vitamins nos, fish oil and cyanocobalamin. On 13 Feb 2021, prior to the onset of symptoms, the patient received their second planned dose of mRNA-1273, (lot number: 030M20A), intramuscularly into right upper arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, after administering the vaccine, patient stated that everything was normal. The patient stated that he went to bed at 9 pm and at 11 pm, he started feeling significant chill and body was feeling hot. On 14 Feb 2021, at 2 am, the patient woke up to go restroom because he was sweating like hell and felt dizziness. The patient's wife noticed that the patient had fainted, and she stood him up and fainted again. His wife made him sat down on the bed and called 911. Once the paramedics arrived, the patient underwent electrocardiogram (EKG) that was normal and checked his blood pressure (BP) that was at 95/82 (unknow units). The patient stated that his BP was usually normal at 120/80 or 85. The paramedics took him to hospital. In the ambulance, they performed another EKG and BG which came out to be normal. The patient was taken to the hospital and they performed multiple blood test that came out to be normal. The patient stated that the nurse gave him unspecified intravenous (IV) liquid as treatment medication for the events which he does not remember. The patient also informed that the doctors concluded that this may happen due to Moderna COVID-19 vaccine. The patient was discharge from the hospital at 4:14 am of 14 Feb 2021. The patient does have light dizziness but not heavy and no other symptoms. The outcome for the event(s), fainting twice, low blood pressure, sweating like hell, significant chills, and body was feeling hot were considered as resolved/recovered on 14 Feb 2021 and that of event, dizziness, was reported as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/13/2021,02/13/2021,0.0,UNK,APTIOM; ZOCOR; ATORVASTATIN; SERTRALINE HCL; ASPIRIN 81; COQ 10; MULTIVITAMINUM; FISH OIL; VIT B12,Cholesterol; Epilepsy,,,,"['Blood pressure measurement', 'Blood test', 'Chills', 'Dizziness', 'Electrocardiogram', 'Hyperhidrosis', 'Hypotension', 'Pyrexia', 'Syncope']",2,MODERNA,OT 1061909,,85.0,F,"Massive stroke; A spontaneous report was received from a consumer (patient's daughter), concerning an 85-year-old female patient, who received Moderna COVID-19 vaccine and death occurred in two days. The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies. She states that her mother was physically and mentally healthy before vaccination. On 29-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of covid-19 vaccine for the prophylaxis of Covid-19 infection. There were no complaints on any side effects from the patient for 6 hours after vaccination. Next day, she was found unresponsive on her bed by her neighbor after they were sent to check on her by her daughter. Her heart was beating, and she was breathing at that time, but did not have consciousness. According to her daughter, the patient had a massive stroke in her sleep sometime between 8:pm on 29-JAN-2021 and 9:30 am on 30-JAN-2021. Her life saving measures were taken out at 1:15 am on 31-JAN-2021 and she died approximately at 1:45am. No information available on hospitalization and treatment received with this event. It is not known whether autopsy was done. Action taken with 2nd dose of Moderna Covid-19 vaccine was not applicable. The outcome of the event stroke is fatal.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of stoke, a causal relationship cannot be excluded. Patient's elderly age is considered a risk factor.; Reported Cause(s) of Death: Massive stroke",Yes,01/31/2021,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Pacemaker insertion (cardiac),,,['Cerebrovascular accident'],1,MODERNA, 1061910,PA,65.0,M,"Passed away; A spontaneous report was received from a Pharmacist concerning a 65 years-old, male patient who passed away/MedDRA PT: death, days after receiving the second dose of the Moderna COVID-19 vaccine. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Lot #012L20A) on 12 Jan 2021. On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot # 030M20A) (route of administration and injection site not provided) for prophylaxis of COVID-19 infection. On an unknown date, days after receiving the second dose of the Moderna COVID-19 vaccine, the patient passed away. The patient did not come to the hospital; therefore the Pharmacist had very little detail of the situation but believed it was due to aspiration based on report received from the patient's boss. The Pharmacist reported there was no report of any issues from the first vaccine. The patient was found at home by spouse and had yellow stuff on face and chest. Action taken with mRNA-1273 was not applicable as the patient deceased. The patient died on an unknown date. The cause of death was reported as unknown. Plans for autopsy were not provided.; Reporter's Comments: Very limited information regarding the event of death has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Death days after receiving the second dose of the Moderna Covid-19 Vaccine",Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Death'],2,MODERNA,OT 1061911,OH,45.0,F,"Died at home; Gasping for air/difficulty breathing; Soreness; A spontaneous report was received from a physician concerning a 45 years-old, female patient who experienced soreness/MedDRA PT: pain, gasping for air/difficulty breathing/MedDRA PT: dyspnoea and subsequently died/MedDRA PT: death. The patient's medical history included blood pressure (disorder not specified), thyroid disorder, depression and anxiety. Concomitant product use included blood pressure medication, thyroid medication and possibly depression and anxiety medication. On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot #007M20A) (route of administration and injection site not provided) for prophylaxis of COVID-19 infection. On 28 Jan 2021, following the vaccination, the patient was fine but had experienced some soreness. Per patient's coworker, the patient did not take any medication as it made the patient sick. The physician was not aware of any complaints from the vaccine. On 13 Feb 2021 at 3:31am, the patient called 911. Per the 911 call, the patient was gasping for air on the call and having difficulty breathing. The patient subsequently died on 13 Feb 2021 at home. The physician inquired whether Moderna gets involved with the autopsy and logistics of the death of patients and wanted to know the time frame for reporting a death of a patient who received the vaccine. The physician did not know who administered the patient's vaccine. Action taken with mRNA-1273 in response to the events was not applicable as the patient deceased. The event died was fatal. The outcome for the events soreness and gasping for air/difficulty breathing was unknown. The patient died on 13 Feb 2021. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding the event of dyspnea and death has been provided at this time. Further information has been requested. Patient's medical history of blood pressure is considered a risk factor. Based on the current available information and temporal association between the use of the product and the onset of the pain, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Died at home",Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,UNK,,Anxiety depression; Blood pressure high; Thyroid disorder,,,,"['Death', 'Dyspnoea', 'Pain']",1,MODERNA,OT 1061912,NY,16.0,F,"accidental vaccination of a 16 year old; A spontaneous report was received from a consumer concerning a 16 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No relevant concomitant medications were reported. On 14 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. The route of administration was unknown. The patient got the first dose of the Moderna vaccine on 14Jan2021. On 11 FEB 2021, the patient was turned away for their second dose because of their age. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event experiencing accidental vaccination was resolved; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1061913,OH,71.0,M,"some vaccine leaked out; some of the vaccine leaked out the arm; vaccine leaked out the arm; A spontaneous report was received from a 71-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and some of the vaccine leaked out of arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient reported he was given his first dose of the Moderna vaccine and some of the vaccine leaked out of his arm. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events were considered recovered on 10 Feb 2021.; Reporter's Comments: This report refers to a case of underdose and exposure via skin contact for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Exposure via skin contact', 'Underdose', 'Vaccination site discharge']",1,MODERNA,OT 1061914,FL,,U,"Bell's Palsy; A spontaneous report was received from a health care professional (HCP) concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's Palsy/facial paralysis. The patient's medical history was not provided. Concomitant medication history was not provided. On 30 DEC 2020, the patients received their first of two doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. The HCP stated that on 25 JAN 2021 the patient developed Bell's Palsy. Treatment for this event was not provided. The outcome of the event, facial paralysis was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/25/2021,26.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Facial paralysis'],1,MODERNA,OT 1061915,FL,71.0,F,"Anaphylactic reaction; swollen throat; eyes itching; eyes swollen; swollen lips; She had hives all around her waistband, back, arms, chest, and her hair; Palms were red; palms were very itchy; her arm was tender; A spontaneous report was received from a consumer concerning a 71-Year-Old female patient, who was administered Moderna's COVID-19 vaccine second dose and her arm was tender, palms were itchy, palms were very red, hives all around waistband, back, arms, chest and hair, swollen throat, swollen lips, eyes swollen and eyes itching and anaphylactic reaction. The patient's medical history was not provided. No relevant concomitant medications were reported. On 13-Jan-2021 the patient received their first of two planned doses of mRNA-1273 (Lot Number:012L20A) Intramuscularly in the left arm. On 11-Feb-2021 prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 11-Feb-2021, patient stated her arm was tender, but she was able to sleep on her side. On 12-Feb-2021 night, her palms were very itchy. On 13-Feb-2021, approximately at 04:30 am patient stated it was like someone had a blowtorched on her palms. Her palms were very red, ""as red can be"" and itching tremendously. When she used the bathroom, she had hives all around her waistband, back, arms, chest and her hair. Patient went to ER. Since her ER visit, patient stated some of her spots on her chest lighten up and her hands were not as bad. Patient denies ever having trouble of difficulty breathing. Patient called again and reported new adverse events from previous one. Patient went to ER for second time on 13 Feb 2021 night and experienced unbearable itching and burning. Patient felt okay until 15-Feb-2021 and went bed and woke up 1:30 am in the morning with swollen throat and lips and she thought she was experiencing anaphylactic reaction. Her eyes were swollen, itchy and needed help. Treatment for the event included patient put an ice pack between her hands for an hour on 13-Feb-2021. The ER gave her diphenhydramine and famotidine and patient was sent home with same medications. Patient also used arnicare gel for her whole waistband, which she stated was very cooling and helped with the burning and itching. Patient received 5 doses of steroids, diphenhydramine and famotidine after second ER visit. The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The events, arm was tender, palms were itchy, palms were very red, hives all around waistband, back, arms, chest and hair, swollen throat, swollen lips, eyes swollen and eyes itching and anaphylactic reaction, were considered unknow.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,02/11/2021,29.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Anaphylactic reaction', 'Erythema', 'Eye pruritus', 'Eye swelling', 'Lip swelling', 'Pain in extremity', 'Pharyngeal swelling', 'Pruritus', 'Urticaria']",1,MODERNA,OT 1061916,CA,,M,"Right leg swelled significantly, particularly at the ankle/Achilles tendon; A spontaneous report was received from a consumer who is a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right leg swelled significantly, particularly at the ankle/Achilles tendon/peripheral swelling. The patient's medical history was not provided. No concomitant medications were reported. On 05 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 06 Jan 2021, the patient reported his right leg swelled up, particularly at the ankle/Achilles and crippled him. He was hospitalized. During his hospitalization the patient had the following tests performed, foot x-ray which showed no damage anatomically and blood work (no results provided). Treatment for the event included anti-inflammatories. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, right leg swelled significantly, particularly at the ankle/Achilles tendon/peripheral swelling, was considered not resolved.; Reporter's Comments: This report concerns a male consumer who received Moderna's COVID-19 Vaccine (mRNA-1273), (Lot # not provided), and within 2 days, experienced serious, unlisted, right leg/Achilles tendon/peripheral swelling. Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/05/2021,02/06/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Blood test', 'Peripheral swelling', 'X-ray limb']",1,MODERNA,OT 1061917,,,F,"grade 3 reaction; Hypotensive; fatigue; cough; A spontaneous report was received from a other health care professional concerning an female patient who developed grade 3 reaction, Hypotension, fatigue and cough/ Adverse reaction: hypotension: Fatigue: cough. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. Prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch no: Unknown) for prophylaxis of COVID-19 infection. On, 25-Jan-2021 developed a grade 3 reaction, hypotension and was admitted to ER and 26-Jan-2021 patient developed fatigue and cough. IV fluids were given as treatment. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The outcome of the events was unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced serious unexpected events of grade 3 adverse reaction and hypotension and then a NS unexpected event of cough and NS expected event of fatigue. The events occurred with unknown latency after the first dose of mRNA-1273. Treatment was not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Adverse reaction', 'Cough', 'Fatigue', 'Hypotension', 'Influenza virus test']",1,MODERNA,OT 1061918,FL,,F,"Blood in right eye; A spontaneous report was received from a consumer concerning a 74 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed blood in her right eye. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number:013l2o8) on 16 JAN 2021 for prophylaxis of COVID-19 infection. Patient woke up on 26 JAN 2021, ten days after initial dose of vaccine, with blood in her right eye. She called to ask if this was a normal side effect of the COVID vaccine. Patient scheduled an appointment with an eye doctor for evaluation and reached out to her PCP. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, blood in right eye, was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/26/2021,10.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Eye haemorrhage'],1,MODERNA,OT 1061919,,,U,"missed second dose (8 week duration between); A spontaneous report was received from a healthcare professional concerning a patient who missed second dose (8 week duration between) of mRNA-1273 vaccine. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date the patient received their first of two planned doses of mRNA-1273 (Lot # not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient missed the second dose by an 8 weeks window. Action taken with mRNA-1273 in response to the event was not provided. The event missed second dose (8 week duration between), was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of a patient of unknown age and gender wo experienced missed second dose (8 week duration between) for mRNA-1273 (Inappropriate schedule of vaccine administered). There were no reported AEs associated with this case of Inappropriate schedule of vaccine administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Inappropriate schedule of product administration'],1,MODERNA,OT 1061920,NJ,59.0,F,"chills; fever; inappropriate schedule of vaccine; Sore for one day and a half; headache; A spontaneous report was received from a consumer and HCP concerning a 59 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events invalid dose (wasn't sure), headache, chills, fever, sore for one day and a half and inappropriate schedule of vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On 26Jan2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On 08Feb2021, prior to the onset of the events, the patient received their second dose (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection. The patient was told to come back in two weeks after the first vaccination to take the shot on 8Feb2021. On that day she had chills, low grade headache and fever for 20hs and sore for one day and a half (from 8 to 9Feb2021). Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events, headache, chills, inappropriate schedule of vaccine, sore for one day and a half and fever were recovered.; Reporter's Comments: This case concerns a 59 year old, female patient, who experienced a non-serious unexpected event of pain among other events, 1 days after receiving 2nd dose of mRNA- 1273 (Lot# 031L20A). This report also refers to a case of inappropriate schedule of vaccine for mRNA-1273, with no associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,02/08/2021,13.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no adverse event history),,,"['Chills', 'Headache', 'Inappropriate schedule of product administration', 'Pain', 'Pyrexia']",2,MODERNA,OT 1061921,MN,66.0,F,"Passed out; Felt lightheaded; Upset stomach; A spontaneous report was received from a consumer concerning a 66 year old female patients who received Moderna's Covid 19 vaccine(mRNA1273) experienced loss of consciousness, dizziness and abdominal discomfort. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. The patient received first of two planned dose of mRNA-1273 for prophylaxis of Covid 19 infection on 14-FEB-2021 intramuscularly in left arm. Patients felt lightheaded and fell unconscious at evening of vaccine administration. EMS was called ,but patient regained consciousness by the time EMS arrived. Patient also experienced abdominal discomfort on the day she got vaccinated. Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The outcome of the event were considered as recovered/resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/14/2021,02/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history provided),,,"['Abdominal discomfort', 'Dizziness', 'Loss of consciousness']",1,MODERNA,OT 1061922,NC,,F,"received the 2nd dose 11 days after the first dose; A spontaneous report was received from a physician concerning a 76-year-old, female patient who received the 2nd dose 11 days after the first dose. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. Patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 6FEB2021. On 17FEB2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 024M20A) intramuscularly for prophylaxis of COVID-19 infection. Physician called to report that patient received the 2nd vaccine 11 days after receiving the first dose of the Moderna vaccine.Treatment information was not provided/unknown. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The event, received the 2nd dose 11 days after the first dose was considered recovered/resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/17/2021,11.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Inappropriate schedule of product administration'],2,MODERNA, 1061923,AZ,,F,"urinary tract infection; Spots; itchiness; A spontaneous report was received from a consumer concerning an 80 year old, female patient who developed urinary tract infection, spots (skin discolouration ) and itchiness (pruritus). The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient received the first dose of the vaccine in her left arm intramuscularly. One day after receiving the vaccine, the patient developed a urinary tract infection. She had never had one before. The patient also reported that she experienced spots and itchiness. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The events, urinary tract infection, spots and itchiness was unknown; Reporter's Comments: Very limited information regarding the reported events have been provided at this time. Patient's medical history, list of concomitant medications, onset date and are lacking including any laboratory test for UTI. Further information has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Pruritus', 'Skin discolouration', 'Urinary tract infection']",1,MODERNA,OT 1061924,TX,85.0,F,"Blood pressure 209/100 plus; atherosclerosis renal arteries; speech changed; severe headaches; Joint pain; A Spontaneous report was received from a Health care professional concerning a � 85 Years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atherosclerosis renal arteries, high blood pressure, severe head ache, joint pain. The patient's medical history was not provided. No relevant concomitant medications were reported. On 8-jan-2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On date or an unknown date, The patient experienced the events atherosclerosis renal arteries, high blood pressure, severe head ache, joint pain. with hospitilization and disability Treatment provided Tylenol, Advil, Norvasc, lisinopril, codeine. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were unknown; Reporter's Comments: This case concerns an 85-year-old female who had serious expected events of headache and serious unexpected speech disorder, increased blood pressure, renal artery arteriosclerosis and NS expected arthralgia. Event onset was the same day as the first dose of mRNA-1273. Treated with Tylenol, Advil, Norvasc, lisinopril, codeine. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/08/2021,01/08/2021,0.0,UNK,LISINOPRIL; AMLODIPINE,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Arthralgia', 'Blood pressure increased', 'Blood pressure measurement', 'Computerised tomogram', 'Headache', 'Renal artery arteriosclerosis', 'Speech disorder', 'Ultrasound kidney']",1,MODERNA,OT 1061925,,,U,"Dosing error (deviation for the recommended 100 mcg dose); A spontaneous report was received from a healthcare professional concerning a unknown patient who received Modern's COVID-19 vaccine (mRNA-1273) and doing error (deviation for the recommednded 100 mcg dose). The patient's medical history and concomitant medication were not reported. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. The health care professional deviated the recommended dose 100 mcg (dosage error) on an unknown date. No Laboratory details provided. No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the events was not reported. The event was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,['Incorrect dose administered'],1,MODERNA,OT 1061926,WA,76.0,F,"feeling really nauseated; vomiting; Patient states when the vaccine was being administered, half the dose squirt out; another syringe was administered in addition to the previous dose; A spontaneous report was received from a consumer concerning a 76-year-old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling really nauseated, vomiting, when the vaccine was being administered, half the dose squirt out (accidental underdose) and another syringe was administered in addition to the previous dose (extra dose administered). The patient's medical history was not provided. Concomitant product use was not provided. On 21-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unkown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 26-Jan-2021, the patient reported feeling really nauseated and vomiting. She stated that she was sick for ten days. Additionally, when the vaccine was administered, patient stated that half of the dose squirt out and another syringe was administered in addition to the first dose. Laboratory details were not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events, feeling really nauseated, vomiting, when the vaccine was being administered, half the dose squirt out (accidental underdose) and another syringe was administered in addition to the previous dose (extra dose administered), was not reported. The outcome of the events, feeling really nauseated, vomiting, when the vaccine was being administered, half the dose squirt out (accidental underdose) and another syringe was administered in addition to the previous dose (extra dose administered), were recovered/resolved.; Reporter's Comments: This case concerns a 76 year old, female patient, who experienced a non-serious expected event of Nausea, vomiting, 7 days after receiving 1st dose of mRNA- 1273 (Lot# Unknown). This report also refers to a case of wrong technique in device usage process and accidental overdose for mRNA-1273 (lot # unknown), with no associated AEs. Very limited information regarding this event has been provided at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Accidental overdose', 'Nausea', 'Vomiting', 'Wrong technique in device usage process']",1,MODERNA,OT 1061927,NJ,,F,"Some of liquid comes out of syringe and doctor did not receive complete 0.5 ml dose; Some of liquid comes out of syringe and doctor did not receive complete 0.5 ml dose; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some of the liquid came out of the syringe and did not receive complete 0.5 ml dose. The patient's medical history was not reported. No Relevant concomitant medications were reported. On 27 Jan 2021, prior to the onset of the events, the patient received their second dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient experienced the events of some of the liquid came out of the syringe and did not receive complete 0.5 ml dose. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events some of the liquid came out of the syringe and did not receive complete 0.5 ml dose were considered resolved on 27 Jan 2021.; Reporter's Comments: This report refers to a case of vaccine underdose and syringe issue for mRNA-1273, lot # unknown with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Syringe issue', 'Underdose']",2,MODERNA,OT 1061928,PA,31.0,F,"may have received an incomplete dose; Patient may have received an incomplete dose because the vial leaked during administration.; A spontaneous report was received from a pharmacist concerning a 31-year-old, female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced accidental underdose and syringe connection issue. The patient's medical history and concomitant medications were not reported. On 27-Jan-2021 the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) for prophylaxis of COVID-19 infection. On 27-Jan-2021, the patient experienced an accidental underdose as the vial leaked during administration. No Laboratory details provided. No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of the events, accidental underdose and syringe connection issue, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of Accidental underdose and Device connection issue for mRNA-1273 (lot/batch: 028L20A) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Accidental underdose', 'Device connection issue']",1,MODERNA,OT 1061929,NJ,,U,"It was administered to an individual who is 17 years old; A spontaneous report was received from a pharmacist concerning a 17 years old patient who received Moderna's COVID-19 vaccine (mRNA-1273). Medical history was not reported. Concomitant medication was not reported. On an unknown date, prior to the onset of the events it was administered to an individual who is 17 years old, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. Action taken with mRNA-1273 in response to the event It was administered to an individual who is 17 years old was not provided. The outcome of the event It was administered to an individual who is 17 years old was resolved. The reporter did not provide the assessment of the event It was administered to an individual who is 17 years old to study drug.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273 with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1061930,NE,16.0,M,"Inappropriate age at vaccine administration; A spontaneous report was received from a Dentist (healthcare professional) concerning a 16 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No relevant concomitant medications were reported. On 22-jan-2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. No Treatment information has been provided. Action taken with mRNA-1273 in response to the events was unknown/ not reported. The outcome, vaccine administered to a 16-year old male, was considered resolved on 22 Jan 2021.; Reporter's Comments: This report refers to a case of Inappropriate age at vaccine administered for mRNA-1273 with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1061931,NY,,F,"They have used a 5/8 inch needle so she believes it was administered subcutaneously; A spontaneous report was received from a healthcare facility staff member concerning a 51-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced incorrect route of product administration. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30-DEC-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) in the right arm for prophylaxis of COVID-19 infection. On 30-DEC-2020, it was reported that a 5/8 inch needle was used and the reporter believed that the vaccine was administered subcutaneously. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, incorrect route of product administration was considered recovered/resolved.; Reporter's Comments: This report refers to a case of inappropriate route of vaccine administration for mRNA-1273 (lot/batch: 026L20A) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Incorrect route of product administration'],1,MODERNA,OT 1061932,OR,53.0,M,"The vaccine leaked out of the vial, it ran down to his elbow; The vaccine leaked out of the vial, it ran down to his elbow; A spontaneous report was received from a consumer, regarding himself, a 53-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273), where vaccine leaked out of the vial, it ran down to his elbow. The patient's medical history was not provided. No relevant concomitant medications were reported. On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (MOD-2021-021503) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 02 Feb 2021, the vaccine leaked out of the vial, it ran down to his elbow. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events vaccine leaked out of the vial, it ran down to his elbow was considered as resolved on 02 Feb 2021.; Reporter's Comments: This case concerns a 53-year-old male who experienced nonserious unexpected events of Device leakage and Incorrect dose administered for mRNA-1273 (lot # unknown) without associated adverse events. He reported that vaccine leaked out of the vial, it ran down to his elbow. The events occurred the same day as the first dose of mRNA-1273. Event outcome resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Device leakage', 'Incorrect dose administered']",1,MODERNA,OT 1061933,NC,16.0,U,"A county inadvertently gave a 16 year old for the first dose of Moderna; A spontaneous report was received from a HCP concerning a 16 Years-old patient of unknown gender who experienced the first dose of Moderna given by a county inadvertently. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. A county inadvertently gave a 16 year old for the first dose of Moderna. Treatment details were not provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event- inappropriate age at vaccine administration was unknown.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown with no reported AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported historical condition.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1061934,VA,16.0,F,"Patient of 17YO received the vaccine; A spontaneous report was received from a health care professional concerning a 17 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No relevant concomitant medications were reported. On 05-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event patient of 17YO received the vaccine was resolved on 05 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot #unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1061935,VA,,F,"Patient of 17YO received the vaccine; A spontaneous report was received from a health care professional concerning a 17 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No relevant concomitant medications were reported. On 05-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event patient of 17YO received the vaccine was resolved on 05 Jan 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1061936,IN,,M,"red spots/blotches on his ankles, hips, back, and chest; little red bumps come up; skin rash; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date in 2021 as a single dose for COVID-19 immunization. Medical history included cancer sores and history of cancer, both from unspecified dates and unspecified if ongoing. Concomitant medications were not reported. On unspecified dates the patient experienced red spots/blotches on his ankles, hips, back, and chest, little red bumps come up and skin rash, all reported as non-serious. The patient called to state that he received the first dose of the Pfizer COVID-19 vaccine ""about 2 and a half weeks ago"" but did not remember the exact date. He stated that his next dose was on 05Feb2021. He called because he had an adverse event and wanted to know what to do. He stated that he had red spots/blotches on his ankles, hips, back, and chest which started after the vaccine was given. He stated he had a history of cancer. He reported that ""I am fine except these little red bumps come up. I have no problem. I have these spots come up and they started down around my ankle and move onto my hips and I have few spots on the back but I do not know if the vaccine caused it or something else, so I thought I better report it anyhow."" He stated that he had not experienced anything, ""just this skin rash or whatever you want to call it"". The patient then inquired if anyone else reported this before. He stated that he just wanted to know if this had anything to do with the COVID-19 vaccine or not. He also stated that ""I do have a 'scan' doctor that takes care of cancer sores (further clarification was unknown) for me but I do not know (incomplete sentence)."" The clinical outcomes of the events red spots/blotches on his ankles, hips, back, and chest, little red bumps come up and skin rash were all unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PVT,,,Medical History/Concurrent Conditions: Cancer; Cancer (NOS),,,"['Rash', 'Rash macular', 'Rash papular']",1,PFIZER\BIONTECH, 1061937,FL,69.0,F,"Feeling numbness in her face around her cheeks and mouth/Her face was really tingling and numb; Feeling numbness in her face around her cheeks and mouth/Her face was really tingling and numb; Difficulty swallowing; Throat started to feel like it was closing up; Tongue got thick; Little blurred vision; This is a spontaneous report from a contactable consumer (the patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 26Jan2021 at 15:46 PM, (at the age of 69-year) as a single dose for COVID-19 immunization. Medical history included hypertension, pacemaker insertion. Concomitant medication was not reported, however, the patient reported that she takes medicines for hypertension, and is on blood thinners. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that on 26Jan2021, after receiving the vaccination she did wait a half hour and the only symptoms she thought at the vaccination visit was a little blurred vision, which was temporary and went away. At 16:30, about 45 minutes to 1 hour after she left the vaccination center, as she was driving home, she informed that she was feeling numbness in her face around her cheeks and mouth/face was really tingling and numb, and she had difficulty swallowing; her throat started to feel like it was closing up and her tongue was really thick. She stated she tried to stay calm and forced herself to drink a bottle of water. She had no idea where there was any emergency area since she was not familiar with the area and tried to calm herself down and took sips of water and made sure she was breathing okay and it all went away. The reaction lasted 10-15 minutes and seem to resolve when she was able to calm herself down. She stated it was scary, and once she calmed down it all went away. She was concerned about receiving the second dose. She did not go to a physician or emergency room, but says she probably should have. The clinical outcome of little blurred vision, feeling numbness in her face around her cheeks and mouth/her face was really tingling and numb, difficulty swallowing, throat started to feel like it was closing up, and tongue got thick was recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Hypertension; Pacemaker insertion (cardiac) (Pacemaker placed),,,"['Dysphagia', 'Hypoaesthesia', 'Paraesthesia', 'Throat tightness', 'Tongue disorder', 'Vision blurred']",1,PFIZER\BIONTECH, 1061938,OH,82.0,F,"Pain on the lymph nodes/lymph nodes hurting; Hurting really bad; Pleurisy before getting the vaccine/after getting the vaccine it got really bad; Pleurisy before getting the vaccine/after getting the vaccine it got really bad; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261; Expiration date: 31May2021) on 21Jan2021 (07:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the clinic (not a military facility). Medical history included being a diabetic from 2005 and ongoing (was not on insulin, only on pills); ongoing chronic obstructive pulmonary disease (COPD) in her 50's (also reported as ""it has been a while""), and was not on oxygen; ongoing anxiety attack; had a problem with her left lymph nodes in her breast; and had pleurisy that was not really that bad (taking paracetamol (TYLENOL)). Concomitant medication included ongoing metformin for being diabetic. In Jan2021, the patient had developed pain on the lymph nodes after receiving the vaccination; and the patient was hurting really bad. The patient was previously diagnosed with pleurisy (prior to the vaccination), and it was described as ""bad enough for her to take Tylenol"" and it was just distracting before. After getting the vaccination, in Jan2021, the patient's pleurisy got really bad, and stated that the vaccine might have attacked her lymph nodes especially the lymph nodes on her left breast, left chest, under arm and back, and that she thought the vaccine had made the pleurisy worse. The patient's condition was so bad that she had to go back to the doctor; events resulted into physician office visit. The patient was informed to take two ibuprofen 200 mg a day as treatment for the reported events. The patient had a chest-ray in Jan2021 after the doctor had diagnosed her with pleurisy (results were not provided). The outcome of the events was not recovered for 'pleurisy that got really bad'; and was unknown for 'pain on the lymph nodes' and 'hurting really bad'.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/01/2021,,OTH,METFORMIN,"Anxiety attack; COPD (It has been a while, was in 50s, not on oxygen); Diabetic (Not on insulin, only on pills)",Medical History/Concurrent Conditions: Lymph node disorder; Pleurisy (not that really bad; taking Tylenol),,,"['Chest X-ray', 'Condition aggravated', 'Lymph node pain', 'Pain', 'Pleurisy']",1,PFIZER\BIONTECH, 1061939,MI,,F,"Eye issues flashes; Floaters; blurred vision; low White Blood Counts; High PTT; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK9231), via an unspecified route of administration in the right arm on 12Jan2021 11:30 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history included high cholesterol. The patient did not have allergies to medications, food, or other products (unspecified). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: atorvastatin calcium (LIPITOR), vitamin D NOS, and macrogol 3350 (MIRALAX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021, the patient experienced eye issues flashes, floaters, blurred vision, and ""IRH"", new sudden onset. Follow up bloodwork revealed low white blood counts and high PTT. The patient stated treatment was received: cautious observation (as reported). The clinical outcome of eye issues flashes, floaters, blurred vision, low white blood counts, and high PTT was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/20/2021,8.0,PVT,LIPITOR [ATORVASTATIN CALCIUM]; VITAMIN D NOS; MIRALAX,,Medical History/Concurrent Conditions: High cholesterol,,,"['Activated partial thromboplastin time', 'Activated partial thromboplastin time prolonged', 'Photopsia', 'Vision blurred', 'Vitreous floaters', 'White blood cell count', 'White blood cell count decreased']",1,PFIZER\BIONTECH, 1061940,IL,92.0,F,"injection site started itching; Strange area around injection site about size of silver dollar, red around outer rim and kind of orangeish colored in the middle; Strange area around injection site about size of silver dollar, red around outer rim and kind of orangeish colored in the middle; feel extremely unwell; feverish 97.5-97.6 degrees Fahrenheit; tired; This is a spontaneous report from a contactable consumer (patient). A 92-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (upper arm) on 20Jan2021 11:00 (at the age of 92years) at single dose for Covid-19 immunization. Medical history included breast cancer, second right breast lumpectomy related to breast cancer from 16Oct2020 to an unknown date, first right breast lumpectomy related to breast cancer on an unknown date (done about 3-4 years prior to second right breast lumpectomy related to breast cancer), on blood thinner, allergic to the statins and allergy to unknown product (She was once given something, some medication for her heart, but about 5- 6 weeks later she developed a reaction to it so she was taken off the medication but does not remember the name of the drug.) The patient would consider herself obese at this weight, but that is probably because she was always very thin historically; her doctor has never diagnosed her as being obese or advised her to lose weight. The patient's daughter had a very, very aggressive form of breast cancer-she is deceased 11 years. Patient's younger sister had breast cancer; there is a lot of breast cancer on her husband's side- his mother, sister, niece all had breast cancer, they have a big history of breast cancer; other types of cancer in patient's family include her mother who died of pancreatic cancer in her 80s; and her dad had prostate cancer but he was in his upper 80s; and patient's older sister died of leukemia. Concomitant medications included warfarin from an unspecified date at 5 mg (daily x 2 days/week) then 2.5 mg (daily x remaining 5 days/week) as blood thinner and metoprolol from an unspecified date at 25 mg, 2x/day (morning and evening) for an unspecified indication. The patient previously had Flu shot. The patient reported that she got on last Thursday (21Jan2021) the first dose of the Covid 19 vaccine at 11 o'clock. She did not feel anything wrong at the moment (also reported as she had no immediate reaction at all). A couple of days after (About maybe 2-3 days later sort of in the middle of the day, not the morning) she started to feel extremely unwell, feverish (although thermometer did not indicate any raise) tired and malaise she was really surprised because it occurred that long after administration. She took Tylenol and she was looking to know if this has been reported as a side effect of the vaccine and how to treat it. She was very concerned about it because she has never had an adverse event with any vaccine or inoculation before. She takes a yearly flu shot and never had any reaction. Feverish: She has taken her body temperature with her digital thermometer which does not show a fever, it shows like 97.5-97.6 degrees Fahrenheit so not a fever; but she feels feverish. On 26Jan2021 the injection site started itching and she looked at site which is way up high so she can't turn her neck that way; but found a strange area around the injection site that is about the size of a silver dollar, red around the outer rim and kind of orangeish colored in the middle. She has never had that occur before, and the skin in the middle of the area, the orangeish colored area has no pain. She reported that there was a mass of people at the location where she was administered the Pfizer COVID-19 Vaccine. There were hundreds of people there when she was for inoculation event so she is wondering if she could have picked up COVID while there. She called to ask about these events related to the product. She has no major allergies. The patient underwent lab tests and procedures on an unspecified date which included body temperature: 97.5-97.6-degree Fahrenheit. The outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/01/2021,,PVT,WARFARIN; METOPROLOL,,"Medical History/Concurrent Conditions: Allergic reaction to drug (Allergy to unknown product); Anticoagulant therapy; Breast cancer (daughter had a very, very aggressive form of breast cancer-she is deceased 11 years); Breast cancer; Leukemia; Lumpectomy (breast cancer) (done about 3-4 years prior to second right breast lumpectomy related to breast cancer); Lumpectomy (breast cancer); Pancreatic cancer; Prostate cancer",,,"['Body temperature', 'Fatigue', 'Malaise', 'Pyrexia', 'Vaccination site discolouration', 'Vaccination site erythema', 'Vaccination site pruritus']",1,PFIZER\BIONTECH, 1061941,AL,73.0,F,"has had a fever since this time; her ileostomy had a blockage that day and she vomited all night; her ileostomy had a blockage that day and she vomited all night; it was very severe and sore and she is just getting over the soreness; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL1283, first dose) solution for injection intramuscular in left deltoid on 18Jan2021 at 14:20 (at the age of 73-years-old) at single dose for COVID-19 vaccination. Medical history included ongoing type 2 diabetes, ongoing active carcinoid cancer of liver, ongoing Ileostomy from Jul2002, surgery in 2001, second primary colon tumor, acid reflux and neuropathy in feet and legs. Concomitant medications included amlodipine besilate for blood pressure, lisinopril for blood pressure, metformin, sitagliptin phosphate (JANUVIA) and gabapentin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient has had a fever since this time on 18Jan2021 and was very severe and sore and she is just getting over the soreness in Jan2021. Temperature was 102 F on 18Jan2021, 101 F on 19Jan2021, the having a fever in varying degrees like 99 F or 100 F after in Jan2021. On 18Jan2021, her ileostomy had a blockage that day and she vomited all night. Treatment for the event fever included ibuprofen (ADVIL). The outcome of the event fever was not recovered. The outcome of the events vomited and ileostomy had a blockage was unknown. The outcome of the event pain was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/01/2021,,PUB,AMLODIPINE BESILATE; LISINOPRIL; METFORMIN; JANUVIA [SITAGLIPTIN PHOSPHATE]; GABAPENTIN,Hepatic cancer; Ileostomy; Type 2 diabetes mellitus,Medical History/Concurrent Conditions: Acid reflux (esophageal); Colon cancer; Neuropathy; Surgery,,,"['Body temperature', 'Gastrointestinal stoma complication', 'Pain', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,OT 1061942,MI,78.0,F,"I have a temp of 100; feel tired; arm is really sore; achy; This is a spontaneous report from a contactable consumer, reporting for herself. A 78-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26Jan2021 at 14:45 (at the age of 78 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included restless legs, high blood pressure, and prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 27Jan2021 at 08:00, the patient experienced temperature of 100, feels tired and achy plus the arm is really sore. The patient did not receive treatment for the events. The clinical outcome of temperature of 100, feels tired and achy plus the arm is really sore was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,PHM,,,"Medical History/Concurrent Conditions: Blood pressure high; COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?: Yes); Restless legs",,,"['Body temperature', 'Fatigue', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH, 1061943,NJ,51.0,F,"blood sugars have been out of control in the range of 400-500's; This is a spontaneous report from a contactable nurse reporting for herself. A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EK9231/expiration date: not provided), via an unspecified route of administration, on 21Jan2021 at 08:00 (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included insulin-dependent diabetes mellitus (IDDM)ongoing since an unknown date and thyroid cancer excised. The patient had a penicillin allergy and Nubain allergy. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EH9899/expiration date: not provided), via an unspecified route of administration, on 31Dec2020 at 04:15 PM (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced her blood sugars have been out of control in the range of 400-500's. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included insulin lispro (HUMALOG), insulin glargine (LANTUS) and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in 2021, the patient experienced blood sugars have been out of control in the range of 400-500's. The event blood sugars have been out of control in the range of 400-500's did not result in hospitalization. The patient received treatment for the event blood sugars have been out of control in the range of 400-500's included increasing the amount of insulin. The patient reported that on both occasions after receiving the vaccination, her blood sugars have been out of control in the range of 400-500's. She was doubling the amount of insulin with little ability to get her sugars within normal range. The outcome of the event blood blood sugars have been out of control in the range of 400-500's was unknown. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on a compatible temporal association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to event ""blood sugars have been out of control in the range of 400-500's"" in this insulin-dependent diabetes mellitus patient cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,,,PVT,HUMALOG; LANTUS; MULTIVITAMINS [VITAMINS NOS],IDDM,Medical History/Concurrent Conditions: Penicillin allergy; Thyroidectomy (thyroid cancer excised),,,"['Blood glucose', 'Diabetes mellitus inadequate control']",2,PFIZER\BIONTECH, 1061944,KS,,M,"Pain at injection site, sore arm. Especially not able after second injection (soreness was much worse) but stated no numbness from the injection as would be very concerned if this occurred.; Pain at injection site, sore arm. Especially not able after second injection (soreness was much worse) but stated no numbness from the injection as would be very concerned if this occurred.; This is a spontaneous report from a contactable consumer. A 23-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: not provided), via an unspecified route of administration, on 05Jan2021 as a single dose for COVID-19 IMMUNIZATION. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: not provided), via an unspecified route of administration, on 26Jan2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced pain at injection site, sore arm with the first dose. On 26Jan2021, the patient experienced pain at injection site, sore arm with the second dose. The patient reported that it was especially notable after second injection (soreness was much worse) but stated no numbness from the injection. The patient believed the individual who administered the second dose may have administered too quickly causing the additional soreness. The events did not require hospitalization. The patient did not receive treatment for the events. The outcome of the events pain at injection site, sore arm was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,,,PVT,,,,,,"['Pain in extremity', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1061945,TN,76.0,M,"blood sugar is higher; This is a spontaneous report from a contactable consumer (patient's wife). This 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose via an unspecified route of administration on 25Jan2021 (at the age of 76 years-old) for COVID-19 vaccination. There was no relevant medical history reported. Concomitant medications were not reported. On an unknown date, his blood sugar was higher. Sometimes he received testosterone injections and it stays high for a couple of days. The clinical outcome of blood sugar was higher was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,,,UNK,,,,,,"['Blood glucose', 'Blood glucose increased']",UNK,PFIZER\BIONTECH, 1061946,NC,83.0,F,"cough; heart rate went up; not feeling well; chills; This is a spontaneous report from a contactable consumer (patient's son) via Medical Information team. An 83-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL1283, NDC number and expiration date were unknown), via an unspecified route of administration in the left arm on 24Jan2021 at 13:30 at a single dose for COVID-19 immunization. The vaccination facility type was reported. The vaccine was not administered at the military facility. The patient had no medical history. She had no family medical history. There were no concomitant medications; the patient had no other products. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on the same date of the Pfizer suspect vaccine. The patient did not require any visit to a physician or emergency room (ER) for the adverse events (AEs). The patient had no prior vaccinations within 4 weeks. The reporter provided information on the side effects of the patient. The patient had the vaccine on 24Jan2021 and she had ""basic"" not feeling well that evening, chills that night; and had developed a cough on Monday evening, on 25Jan2021. She was still coughing and didn't feel well. The reporter didn't know if it was due to the vaccine. The patient was still with coughing and just not feeling good. The reporter was asking if the coughing was related to the vaccine, was it normal for the vaccine, or should she get the test. The reporter further stated that in the afternoon of 24Jan2021, the patient was not feeling well and had chills that evening. The reporter added that the patient's heart rate went up with the chills on 24Jan2021 in the evening, but then went back down when the chills went away on 25Jan2021. The reporter mentioned that the patient's husband had it (vaccine) at the same time and had no problem. The patient was scheduled for the second dose of the vaccine, but the reporter did not have the paper to provide the date. The reporter assessed the events as non-serious. The patient recovered from the events ""chills and heart rate went up"" on 25Jan2021, while she was not recovered from the events ""not feeling well and cough.""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/24/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Cough', 'Heart rate', 'Heart rate increased', 'Malaise']",1,PFIZER\BIONTECH, 1061947,,,M,"bruising above the knees and on his lower legs; fall; Pain as if he had the flu; This is a spontaneous report from a non-contactable consumer (patient). This male patient of unspecified age received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unknown route of administration on 13Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. After his second dose the patient reported bruising above the knees and on his lower legs; the patient also mentioned a fall. He stated he had pain as if he had the flu. The patient was most worried about the pain and bruising in his legs; he inquired if that was normal/reported nearly two weeks after a dose, and what he should do. He reported that he called his physician and if it's not better by ""this."" The patient was also looking for information that he could be sent. The clinical outcomes of bruising above the knees and on his lower legs, fall, and pain as if he had the flu were unknown. No follow-up attempts are possible; information about lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/01/2021,,UNK,,,,,,"['Contusion', 'Fall', 'Influenza like illness']",2,PFIZER\BIONTECH, 1061948,IL,44.0,F,"injection site pain; tiredness; headache; muscle pain; chills; joint pain; Eye pain; fever =(on Tylenol); feel febrile and woke up with the sweats at 2:am; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable nurse (patient). This 44-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3249) intramuscularly in the right arm on 26Jan2021 (at the age of 44-years-old) at 11:00 as a single dose for COVID-19 immunization. Medical history included allergy to bee stings. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took thimerosal on an unknown date for an unknown indication and experienced drug allergy. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) on 05Jan2021 at 10:30 intramuscularly in her right arm. On 27Jan2021 at 02:00 the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, ""fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am,"" injection site swelling, injection site redness, nausea, and feeling unwell. No treatment was provided for the events. Therapeutic measures were taken as a result of fever and included paracetamol. The clinical outcomes of injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, ""fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am,"" injection site swelling, injection site redness, nausea, and feeling unwell were unknown. It was also reported the patient was not COVID tested post-vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/27/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Bee sting hypersensitivity (known allergies: bee stings),,,"['Arthralgia', 'Chills', 'Eye pain', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",2,PFIZER\BIONTECH,OT 1061949,LA,79.0,F,"pain in the injection site and arm/pain at injection site all the way to her elbow; pain in the injection site and arm/pain at injection site all the way to her elbow; felt like someone stuck a knife in her muscle; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number A3249 and expiry date unknown, via unspecified route of administration at the left arm on 21Jan2021 at single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications included other medications. The patient had the first dose of the Pfizer vaccine on 21Jan2021 and the following day (22Jan2021), she experienced pain in the injection site and arm. The patient informed that it felt like someone stuck a knife in her muscle. The patient informed that the pain was improving and not sure if she wanted to get the second dose. The patient informed that she had a dental procedure done and was taking pain medication to help with that but it didn't help with her pain in her arm from the shot. The patient has been having pain at injection site all the way to her elbow. The patient informed that the first day they it was like she had a shot. The patient informed that it felt like a knife was being stuck in her muscle the second day (22Jan2021). The patient informed that today it felt like pressure. The patient informed that at night time that she sleeps perfect and when she gets up in the morning that it was bad pain. The patient informed that she was leery about getting her second shot. The patient informed that she had two teeth pulled on Friday (unspecified date) after she got the vaccine. The patient informed that they redid her partial for those teeth. The patient informed that they had prescribed 800 mg of ibuprofen for her teeth. The patient stated that she thought it would help the pain in her arm but it did not. The patient was told to keep taking it but she stopped. The patient informed that she has to take antibiotics for her teeth until they were all gone. Therapeutic measures was received by the patient due to the events. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/22/2021,1.0,UNK,,,,,,"['Myalgia', 'Pain in extremity', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1061950,TN,88.0,F,"hardly got sore; Chills; Nausea/Nauseated; This is a spontaneous report from a contactable consumer, the patient. A 88-years-old female received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration in left arm on 11Jan2021 at 14:00 (at the age of 88-years-old) as a single dose for Covid-19 immunisation. Medical history included Covid-19 from Dec2020 to an unknown date ('quarantine was over a few days before Christmas'.), Heart attack, Had four stents placed, ongoing Blood pressure high , ongoing blood cholesterol , drug hypersensitivity ('allergic to lots of medications'). Concomitant Medication include 'blood thinners, blood pressure, cholesterol, that sort of thing'. No additional details provided. No other vaccines were given within 4 weeks. On 12Jan2021, The patient experienced chills all day long. She never ran a temperature. She got nauseated around 9:00 PM-9:30 PM and on an unspecified date reported she hardly got sore, no additional details provided. She drank ginger ale, went to bed. She got up the following morning and was fine. By 13Jan2021 she felt fine and no longer had chills or nauseated. The adverse events did not require a visit to the emergency room or physicians office. Consumer inquired if she can use antipyretics before or after vaccination of the covid-19 vaccine. The patient is scheduled to get the second dose on 01Feb2021. The clinical outcome of the event is chills and nausea were recovered on 13Jan20201 while hardly got sore was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/12/2021,1.0,UNK,,Blood pressure high; Cholesterol,Medical History/Concurrent Conditions: COVID-19 (Her quarantine was over a few days before Christmas.); Drug allergy (allergic to lots of medications); Heart attack; Stent placement,,,"['Chills', 'Nausea', 'Pain']",1,PFIZER\BIONTECH, 1061951,,,F,"a little sore; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received 1st dose 20Jan2021 and was scheduled for 2nd dose 10Feb2021. She has heard other people get very sick after getting 2nd dose but does not know of anyone that has gotten sick after getting vaccine and stated she has heard that somewhere and wanted to know if that's true. Also said after her 1st dose she did not get sick, but she was a little sore but that's it. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/01/2021,,UNK,,,,,,['Pain'],1,PFIZER\BIONTECH, 1061952,MA,,F,"she was exposed to COVID and then started getting symptoms; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. Medical history included COVID-19. The patient's concomitant medications were not reported. Last Wednesday (20Jan2021), the patient got the first dose of Pfizer COVID19 vaccine. On Thursday (21Jan2021), the patient was notified that she was exposed to COVID on unspecified date and then started getting symptoms on Sunday (24Jan2021). She did not provide details on the ""symptoms"". The patient underwent swab test (COVID-19 virus test) on unspecified date with pending result (unknow result). Outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,,,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Exposure to SARS-CoV-2', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1061953,NC,77.0,F,"Blinding headache/ severe headache; chills/ shivers; couldn't warm up; Whole body was shaking out of control/ She got the shakes so bad she shook for like 5 hours; Neck froze completely; She can't move her head up and down normal/ couldn't move her head; Pain in her neck; pulled muscles; Muscles were so sore; Fatigue/Extreme tiredness; Weakness; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL0140), via an unspecified route of administration at the right arm on 13Jan2021 at a single dose for COVID-19 immunization. The patient had anaphylactic shock in the past to a sulfur antibiotic. There were no concomitant medications. She stated she did not have an extreme reaction for the first 3-4 days, it was fine and went away. She had fatigue, joint pain, all the regular things and they were easing up. She had an appointment on the 20Jan2021 and thought things were going okay. On day 7, 20Jan2021, that night, she had an extreme reaction of blinding headache, the shakes, her whole body was shaking out of control for hours, her neck froze completely, and she can't move her head up and down normal (this is still occurring). The patient has had joint paint on 14Jan2021; extreme tiredness, weakness and muscle pain on 15Jan2021; chills, pain in her neck and muscles were so sore from 20Jan2021. She figured that was side effects, and she was handling, and then exactly a week after, she got the shakes so bad she shook for like 5 hours, she had to put nightguard in her mouth to stop from cracking, and severe headaches and her neck completely locked up, she couldn't move her head, and she still can't. She had extreme headache, and she went to the ER on 26Jan2021, since she was in really bad shape, they wouldn't believe her that it was a COVID reaction, she was there for 12 hours, they did every test, she had spinal taps, she had a head X-ray, everything, as they said she had meningitis, but then ruled that out, they wouldn't believe she was having a reaction to the COVID shot, she can't move her head, her joints and that are ok otherwise, but she can't move her head, she has pain in her neck, and she is taking Excedrin for that. She stated her doctor told her to go ahead and take the second dose of the vaccine and just take Tylenol after. She stated Tylenol has no effect whatsoever. If she takes Excedrin the headache will go away and Tylenol won't budge it. She stated she is taking Excedrin regardless of what the doctor says. When asked for age of onset, states she was on Valium and she was not thinking straight, and asked her husband her age. She was not sure why it was given, now provides name as Diazepam 5mg. Muscle pain is fine now, it went away. She went to the doctor on 20Jan2021, as she had a regular appointment for bloodwork to be done, and said she felt pretty good, she had some reaction but was fine, and that night is when she got shakes and shivers so bad, she had 3 quilts on and couldn't warm up, her body was out of control, she couldn't stop, now states for 3-4 hours. Severe headaches started the night of the 20Jan2021. Her neck pain started right after the shakes, so maybe she pulled muscles when she had the shakes, the muscles were so sore, and she couldn't move her head, like down or to the side, she couldn't move it, which is why she went to the hospital, to the ER. She was there for 12 hours. She started taking Excedrin, states she ignored what the doctor told her. She knows her body and she can take Tylenol and Ibuprofen like it is candy, and it does nothing, one Excedrin puts everything away, she swears by Excedrin. The outcome of the event shaking recovered on an unspecified date; Joint pain and Muscle pain recovered on 19Jan2021; Blinding headache/ severe headache, Fatigue/Extreme tiredness was recovering, chills/ shivers, couldn't warm up, Neck froze completely, pulled muscles, fatigue was unknown; she can't move her head up and down normal/ couldn't move her head, Pain in her neck, Muscles were so sore, Weakness was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Anaphylactic shock,,,"['Arthralgia', 'Asthenia', 'Blood test', 'Chills', 'Fatigue', 'Feeling cold', 'Headache', 'Lumbar puncture', 'Movement disorder', 'Muscle strain', 'Musculoskeletal stiffness', 'Myalgia', 'Neck pain', 'Skull X-ray', 'Tremor']",1,PFIZER\BIONTECH, 1061954,FL,66.0,F,"veins in her hands are still swollen in the arms, its like the veins popped up; Numbness in arms and Hands; Tingling in Arm and Hands; some pain in the injection arm; muscles pain in the hands; a freezing cold sensation in her hands/her hands were frozen for 3-4 seconds; I would wake up with one hand completely numb; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in left arm on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included osteopenia and osteoporosis. She was shrinking, her height was about 5 feet 5 inches, she used to be 5 feet 7 inches. Concomitant medication included calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D3 [CALCIUM CARBONATE;COLECALCIFEROL]), fish oil, vitamin e nos (OMEGA 3 [FISH OIL;VITAMIN E NOS]), vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]), and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). It was reported that on 09Jan2021, she received the first dose of the vaccine. She started to feel tingling and numbness in both hands the same day after the vaccine was administered. She states she also had some pain in the injection arm and that the numbness/tingling was off and on and traveled to her arms occasionally. She states, ""I would wake up with one hand completely numb and it was worse the first 15 days but is getting better and is a little less than before."" She states she would have a freezing cold sensation in her hands occasionally and she states her veins were more prominent and visible in her hands/arms around the 13th day after getting the vaccine. She further reported that when she received the vaccine, that same afternoon she started feeling a tingling sensation in the hands and arms, also a sensation of numbness like electrical accompanied with muscle pain. The Numbness and Tingling was on and off and well as the muscles pain in the hands. It was more noticeable 13-14 days later now. She would be sleeping at night and would wake up because of the sensation in the left hand or on the other right hand. The hands would wake her up. She provides an example of its like when your foot is asleep with the pins and needles, because you had your foot squished under for a while, like the foot falling asleep but in this case she wasn't doing anything and would have that feeling. Once or Twice when having breakfast she noticed that her hands were frozen for 3-4 seconds. After the 13 or 14 days, things are milder but now she still has the sensation, its not so often but milder. She also notices the veins in her hands are still swollen in the arms, its like the veins popped up. She is still having this. She is concerned since she is suppose to get second injection on 30Jan2021, she is concerned if she should still it. She is nervous. She clarifies that the first dose was on 09Jan2021 at 10 or 10:15 AM. On the same day is when she started noticing the Numbness and tingling in the Hands and arms on 09Jan2021. She noticed the Veins popping on 22Jan2021. Caller clarifies that she has no side effects in the legs, she was just providing that comment as an example. The outcome numbness in arms and hands, tingling in arm and hands, wake up with one hand completely numb, was recovering; pain in the injection arm, muscles pain in the hands, freezing cold sensation in her hands was unknown; and veins in her hands are still swollen in the arms was not recovered. The reporter assessed the events as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/01/2021,,UNK,CALCIUM WITH VITAMIN D3 [CALCIUM CARBONATE;COLECALCIFEROL]; OMEGA 3 [FISH OIL;VITAMIN E NOS]; VITAMIN B12 [VITAMIN B12 NOS]; VITAMIN C [ASCORBIC ACID],,Medical History/Concurrent Conditions: Osteopenia; Osteoporosis,,,"['Body height', 'Hypoaesthesia', 'Myalgia', 'Paraesthesia', 'Peripheral coldness', 'Sleep disorder', 'Vaccination site pain', 'Vein disorder']",1,PFIZER\BIONTECH, 1061955,FL,65.0,F,"She didn't feel well last night; Weakness in left thigh and leg/leg was so weak she could not get up; Fell down 3 times; This is a spontaneous report from a contactable consumer (patient) and healthcare professional. A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1283), via an unspecified route of administration on 25Jan2021 11:30 at single dose (arm left) for COVID-19 immunization. Medical history included costochondritis, vertigo, autoimmune disease, uses a walker, inflammation of the cartilage between the rib and sternum and pulled muscle. Concomitant medications included methylprednisolone (MEDROL) (also reported as steroid pak) from Jan2021 to Jan2021 for pulled muscle and ketorolac tromethamine (TORADOL) from Jan2021, both for inflammation of the cartilage between the rib and sternum. The patient previously took iodine and experienced allergies. It was reported that the patient just got the first Pfizer BioNTech Covid-19 vaccine yesterday, 25Jan2021, 11:30 am. Last night, at 19:00, she had weakness on the left side of the body, especially in the thigh, and she fell down 3 times last night. Her leg was so weak she could not get up. She just got off the phone with the doctors office and was told to report this. The patient did not received therapy for the events weakness in left thigh and leg/leg was so weak she could not get up and Fell down 3 times. On 26Jan2021, the patient experienced didn't feel well last night. She was also on a Medrol pack about a week ago and just finished her last dose last night when she took the vaccine. The nurse practitioner at the doctor's office was wondering if it could have been an interaction between the Medrol pack and the vaccine. She got an email saying she could get the vaccine, but didn't think to call the doctor office to ask about the Medrol pack (steroid pack) or if it could cause any interactions. So the office told her to call. Later mentions along with the Medrol pack, she got an injection in the office of Toradol and this was before getting the vaccine. She stated that she did have her on a steroid pack for a pulled muscle so that may have exacerbated the issue. The weakness and things have improved so she was still a little nervous and uses a walker and just making sure to take it easy today. The patient had no other vaccines in 4 weeks and other medications in two weeks included steroid Pak. Patient had no problems with vaccines in the past. The patient had no Covid prior vaccination and was not Covid tested post vaccination. The patient had no events following prior vaccinations. Patient stated that they had been lucky and they have been tested before and has not had it yet, so that was why they wanted to get the vaccine done. She just rested and her husband helped her to bed since she didn't feel well last night. She did not have any trouble breathing. Patient underwent a Chest x-ray in Jan2021 and nothing showed up on it, but just some old calcifications from many years ago. That was done sometime last week and she also had like 3 MRI's on an unspecified date. Patient was wondering if she should she get the second dose. Her next appointment was on 16Feb2021. She was pretty banged up and does not want to have to go through that again. Outcome of events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,WRK,MEDROL [METHYLPREDNISOLONE]; TORADOL,,Medical History/Concurrent Conditions: Autoimmune disorder (Has history of vertigo and an autoimmune disease); Costochondritis (inflammation of the cartilage between the rib and sternum); Costochondritis; Pulled muscle; Vertigo (Has history of vertigo and an autoimmune disease); Walker user (uses a walker.),,,"['Chest X-ray', 'Fall', 'Investigation', 'Magnetic resonance imaging', 'Malaise', 'Muscular weakness']",1,PFIZER\BIONTECH, 1061956,,,M,"Sinus drainage; Dizziness and tiredness that comes and goes; Dizziness and tiredness that comes and goes; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, after receiving vaccine the patient then developed dizziness and tiredness that comes and goes. He also states he has sinus drainage which he says may have started before vaccine. The clinical outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/01/2021,,UNK,,,,,,"['Dizziness', 'Fatigue', 'Upper-airway cough syndrome']",UNK,PFIZER\BIONTECH, 1061957,FL,76.0,F,"sore throat; Tenderness of the Right Arm; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EH9899), via an unspecified route of administration on the right arm, at age 76 years first dose on 22Jan2021 at single dose for COVID-19 vaccination. Medical history was none. There were no concomitant medications. Patient had the vaccine first dose on Friday (22Jan2021), she had tenderness in the arm at the site but nothing major. Then this morning (27Jan2021) she had a really bad sore throat, it's really sore. She asks if this is a side effect. She asks can she take aspirin or Tylenol. Reporter Type: She has worked in a doctors office in the past but it was just doing medical records. She confirms that on 22Jan2021 was her first dose of the covid vaccine, the tenderness of the arm was on the same day, it happens anytime she gets a shot, the Sore Throat started this morning. Primary care: Declined, she has only been going through the vaccine program. The tenderness of the right arm, is barely there, its like nothing there, its just a little. For the Sore Throat , she drank from tea and had a lozenge and so its not as but is still there but not terrible. Patient stated that she just want to know if she can take aspirin or Tylenol Covid Vaccine Card: The Expiry is not written on the card. Date of second dose: 12Feb2021 Concomitant Medications; No She was just sleeping and woke up with it. The outcome of the event sore throat was not recovered, while for the other event, it was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Oropharyngeal pain', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 1061958,CA,45.0,F,"Headache; Muscle fatigue; Lymph node pain; Left armpit; This is a spontaneous report from a contactable nurse (patient). A 45-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: GL92113), intramuscular on 22Jan2021 at 14:15 at a single dose on left arm for COVID-19 immunisation. Medical history included depression, mitral valve regurgitation and hypercholesterolaemia from an unknown date and unknown if ongoing. The patient previously took guaifenesin;phenylephrine hydrochloride (ENTEX) and NOVICAINE and experienced allergies. The patient experienced headache, muscle fatigue, lymph node pain and left armpit on 22Jan2021. Treatment received for the adverse event was reported as No. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Depression; Hypercholesterolemia; Mitral regurgitation (mitral valve regurgitation),,,"['Headache', 'Lymph node pain', 'Lymphadenopathy', 'Muscle fatigue']",1,PFIZER\BIONTECH,OT 1061959,TX,66.0,F,"Headache in the back of my neck radiating up into the back of my head; Headache in the back of my neck radiating up into the back of my head; Projectile vomiting; Dry heaves; Fever; Chills; Muscle spasms; Swollen glands; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported) on 26Jan2021 (10:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included allergy-induced asthma; Celiac disease; bradycardia; was a pacemaker user (for bradycardia); sulpha allergy; and latex allergy. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), alprazolam, lisinopril, montelukast, and other unspecified medications. The patient previously took cephalexine, and had allergy. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on the left arm on 07Jan2021 (when the patient was 66 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 26Jan2021 (23:00), the patient had headache in the back of the neck, radiating up into the back of the head; projectile vomiting; dry heaves; fever; chills; muscle spasms; and swollen glands. The patient did not receive any treatment for the reported events. The outcome of the events, 'headache in the back of the neck, radiating up into the back of the head', 'projectile vomiting', 'dry heaves', 'fever', 'chills', 'muscle spasms' and 'swollen glands', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,PVT,ADVAIR; ALPRAZOLAM; LISINOPRIL; MONTELUKAST,,Medical History/Concurrent Conditions: Artificial cardiac pacemaker user (for bradycardia); Asthma; Bradycardia; Celiac disease; Latex allergy; Sulfonamide allergy,,,"['Chills', 'Headache', 'Lymphadenopathy', 'Muscle spasms', 'Neck pain', 'Pyrexia', 'Retching', 'Vomiting projectile']",2,PFIZER\BIONTECH, 1061960,WI,51.0,F,"Stomach cramps; arm soreness; severe vertigo; nausea; unable to get up or walk; dizziness; Dose Number 2, Date of start of drug 21Jan2021/ Dose Number 1, Date of start of drug 29Dec2020; This is a spontaneous report from a contactable nurse (patient). A 51-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249, expiration date: unknown), via an unspecified route of administration on the left arm on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no allergies to medications, food, or other products. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiration date: unknown) in the left arm on 29Dec2020 at 15:00 (3:00PM) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Jan2021 at 04:00, the patient experienced stomach cramps and arm soreness for two days. On the same day, the patient experienced severe vertigo with nausea and was unable to get up or walk. The following day, 24Jan2021, vertigo was slightly less. On the fifth day, the patient was still having some dizziness and nausea. No treatment was administered for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The events stomach cramps and arm soreness resolved in 25Jan2021, and the events nausea, unable to get up or walk and dizziness had not resolved, while the event severe vertigo was resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,UNK,,,,,,"['Abdominal pain upper', 'Dizziness', 'Gait inability', 'Inappropriate schedule of product administration', 'Nausea', 'Pain in extremity', 'Vertigo']",2,PFIZER\BIONTECH, 1061961,,,F,"little chills; fatigue; right arm pain, left arm pain; light fever (99.7); This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26Jan2021 as a single dose for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. On 27Jan2021, the patient experienced little chills, light fever 99.7 (unknown unit), right arm pain and then her left arm was painful, and fatigue. The patient wanted to know if this was normal. The clinical outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/27/2021,1.0,UNK,,,,,,"['Body temperature', 'Chills', 'Fatigue', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH, 1061962,,,F,"Lupus and Idiopathic pulmonary fibrosis; Lupus and Idiopathic pulmonary fibrosis; patient had fever, had short of breath, had terrible dry cough; like when having flares; Was short of breath; terrible dry cough; Fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. and expiry date not reported), via an unspecified route of administration on 21Jan2021 at a single dose for covid-19 immunization. Medical history included Lupus and Idiopathic pulmonary fibrosis. She takes Hydroxychloroquine and Mycophenolate 50 mg for it. The patient's concomitant medications were not reported. On Jan2021, 3 days after vaccine administration, patient had fever, had short of breath, had terrible dry cough; like when having flares. She wanted to know should she take the second dose or not. She also asked the protection percentage after the first dose. Outcome of the events was unknown. Information about lot/batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Idiopathic pulmonary fibrosis (She takes Hydroxychloroquine and Mycophenolate 50 mg for it.); Lupus syndrome,,,"['Condition aggravated', 'Cough', 'Dyspnoea', 'Off label use', 'Product use issue', 'Pyrexia']",1,PFIZER\BIONTECH, 1061963,CA,,F,"shortness of breath; throat felt really tight; joint pain; body aches; nausea; fever/higher fever up until 100.2 Degree F; injection site hurting, swelling; injection site hurting, swelling; coughing; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, via an unspecified route of administration on 19Jan2021 at a single dose for an COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 20Jan2021, the patient had the ""normal"" adverse effects: joint pain, body aches, nausea, fever. On the 21Jan2021, she developed shortness of breath since her throat felt really tight and was prescribed with steroids, but she still feels tightness in her throat. On the 25Jan2021 she got higher fever up until 100.2 Degree F. On 26Jan2021, she went to urgent care and they did a COVID test on her and prescribed an inhaler for her. Today the test result came back negative but she still got nausea, injection site hurting, swelling and coughing in Jan2021. The event nausea, throat felt really tight, injection site hurting, swelling and coughing was not recovered while for other events was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/01/2021,,UNK,,,,,,"['Arthralgia', 'Body temperature', 'Cough', 'Dyspnoea', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test', 'Throat tightness', 'Vaccination site pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 1061964,FL,,F,"her whole left side went weak and she fell down 3 times; her whole left side went weak and she fell down 3 times; not doing so well; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 26Jan2021 11:30, at single dose, for covid-19 immunization and; methylprednisolone (MEDROL, tablet), via an unspecified route of administration, from an unspecified date, at unknown dosage, for inflammation in the cartilage in the ribs. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer Covid vaccine yesterday 26Jan2021 at around 11:30; and later that night she had a really bad reaction where her whole left side went weak and she fell down 3 times also, she was not doing so well. She then talked to her doctor who instructed her to call in the adverse event to find out if the Medrol dose pack that was prescribed for her inflammation in the cartilage in the ribs may have caused a reaction or if there was a correlation. The action taken in response to the events for BNT162B2 was not applicable while for methylprednisolone was unknown. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/26/2021,0.0,UNK,MEDROL,,,,,"['Fall', 'Hemiparesis', 'Malaise']",UNK,PFIZER\BIONTECH, 1061965,CT,76.0,M,"Quite tired; He has a slight headache; he felt achy/Body aches and pains; Injection site pain; Had a fever 99.7F, 99.9 fever, later 101F; discomfort/slight injection site discomfort; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number EL9263, expiry date not reported), intramuscular on 26Jan2021 12:00 at a single dose in the left arm for COVID-19 immunization. Medical history included years ago he did have an issue with a lung disease when he went to (country name); he did have COVID 19 in Mar2020 and he recovered from that; high blood pressure; psoriatic arthritis diagnosed 30 years ago; and non-smoker. Family medical history included that they are all smokers in his family, and he is not. His sister died of pancreatic cancer and his mother died of oat cell lung cancer. Concomitant medications included valsartan (DIOVAN 160 mg) for high blood pressure at 160 mg, daily started 3.5 years ago to an unknown date; and patient was taking some health store vitamins. The patient previously took infliximab (REMICADE) on unspecified dates 5 years ago as Arthritis medication administered IV and apparently it lowered his immune system and he wound up in the hospital with a lung infection. He recovered completely. He does not have a lot or expiration. It was administered in the doctor's office and he does not go to that doctor anymore. It was reported that patient had no prior vaccinations (within 4 weeks). He had second dose of Shingles vaccine and it was close to 4 weeks ago. Shingrix administered on upper left arm received it at an in-store clinic, and patient had slight injection site discomfort. No other vaccines administered on same date of the Pfizer suspect. Patient received the first dose of the Covid 19 vaccine on 26Jan2021 at noon, with just a bit of discomfort. He seemed to be fine except slight injection site discomfort, also reported as injection site discomfort on left upper arm, on 26Jan2021. Later that night (also reported as last night 26Jan2021 23:00) he felt achy, he had bad body aches and pain and still has it this morning. Injection site pain worsened last night and now it has improved. He woke up in the middle of the night, and had a fever 99.7 F, 99.9 fever and later it went as high as 101 F (26Jan2021). He took Advil and Tylenol. The body aches improved after he took 2 Tylenol when he took his temperature. He took temperature about 1.5 hour ago. He went into bed and waited and took it again about 1/2 hour ago and it went up to 101. He then took Tylenol and took his temperature again. This morning (27Jan2021) his temperature was now back/down to 99.3 F. He was still feeling aches but not as bad as before. He might still have a slight temperature now, but it has improved. He believed vaccination was given in the muscle because it was in the upper part of his arm where the skin is thinner. He had a slight headache and was quite tired (27Jan2021). Patient asked if there's anything he should do or be concerned about. He was scheduled for the second dose on 16Feb2021 and he heard that the second dose was stronger than the first one, that after the second dose there may be more side effect, and he wanted to know if this is true and wanted to know if he can get the second dose. Therapeutic measures were taken as a result of the events discomfort/slight injection site discomfort, he felt achy/body aches and pains, fever, and injection site pain. Patient had no ER or physician's office required. The events discomfort/slight injection site discomfort, he felt achy/body aches and pains, fever, and injection site pain were recovering. The outcome of the event tired and headache was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,UNK,DIOVAN,,Medical History/Concurrent Conditions: Blood pressure high; COVID-19 (He recovered from that.); Hospitalization; Lung disease (Years ago he did have an issue with a lung disease); Non-smoker; Pancreatic cancer (sister died of pancreatic cancer); Psoriatic arthritis (Diagnosed 30 years ago.); Small cell lung cancer stage unspecified (mother died of oat cell lung cancer); Smoker (all smokers in his family),,,"['Body temperature', 'Fatigue', 'Headache', 'Pain', 'Pyrexia', 'Vaccination site discomfort', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 1061966,MO,40.0,F,"rash appeared in both upper arms/the rash had extended to the rest of the arms/ both legs also displayed the rash; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), via an unspecified route of administration in left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunisation. The patient has no medical history. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 25Jan2021 21:00, a few hours after receiving the vaccine, a rash appeared in both upper arms. By the end of the day, the rash had extended to the rest of the arms. After 36 hours of receiving the vaccine, both legs also displayed the rash. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,SCH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Rash'],1,PFIZER\BIONTECH, 1061967,CA,59.0,F,"fatigue; swollen lymph nodes above the left clavicle that sore; swollen lymph nodes above the left clavicle that sore; This is a spontaneous report from a contactable health care professional nurse, the patient. A 59-years-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL 3246), via unspecified route of administration in the left arm on 20Jan2021 at 13:00 (at the age of 59-years-old) as a single dose, for COVID-19 vaccination. Medical history included asthma (Chronic Asthma but controlled). The patient had no known allergies. Concomitant medication included Albuterol, Singular, Zyrtec, multi vitamin. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 25Jan2021, The patient experienced fatigue, swollen lymph nodes above the left clavicle that sore. Reported non serious adverse event of fatigue, swollen lymph nodes above the left clavicle that sore and still present on 27Jan2021. No treatment was given for the events. The clinical outcome of the events fatigue, swollen lymph nodes above the left clavicle that sore was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/25/2021,5.0,UNK,ALBUTEROL [SALBUTAMOL]; MULTI VITAMIN [ARGININE HYDROCHLORIDE;ASCORBIC ACID;CALCIUM;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FERR; SINGULAIR; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Asthma (Chronic Asthma but controlled),,,"['Fatigue', 'Lymph node pain', 'Lymphadenopathy']",1,PFIZER\BIONTECH, 1061968,MO,58.0,F,"Large painful Lymphadenopathy on L side of neck near clavicle, the size of a lemon; This is a spontaneous report from a contactable other healthcare professional (the patient). A non-pregnant 58-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231), intramuscular in the left arm, on 17Jan2021 at 08:30 AM (at the age of 58 years) as a single dose for COVID-19 immunization. Medical history included high cholesterol. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included estradiol (ESTROGEN), pravastatin. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 12:00 PM, the patient developed large painful lymphadenopathy on the left side of neck near clavicle, the size of a lemon. The event was reported as non-serious. Therapeutic measures were taken as a result of large painful lymphadenopathy on left side of neck near clavicle, the size of a lemon. The clinical outcome of the large painful lymphadenopathy on the left side of neck near clavicle, the size of a lemon was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/17/2021,01/20/2021,3.0,PVT,ESTROGEN; PRAVASTATIN,,Medical History/Concurrent Conditions: High cholesterol,,,['Lymphadenopathy'],1,PFIZER\BIONTECH,OT 1061970,CT,,F,"Just a little pain at the injection site and is kind of tired today; Just a little pain at the injection site and is kind of tired today; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age (reported as 89, unit unspecified) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 26Jan2021 10:55, at single dose, for covid-19 immunization, at the hospital. The patient medical history was not reported. Concomitant medication included rivaroxaban (XARELTO) from 2020. The patient reported that she had no reaction, just a little pain at the injection site in Jan2021 and was kind of tired on 27Jan2021 (today). The patient also reported that after she got the vaccine, they gave her a fact sheet. She just read it in the morning of 27Jan2021 (this morning). It said that you should mention if you have any allergies, fever, bleeding disorders, or are on a blood thinner. The patient stated she is on XARELTO for over a year now. The patient was wondering what complications would arise from this. The outcome of the events was unknown. Information about the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/01/2021,,PVT,XARELTO,,,,,"['Fatigue', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1061971,CT,92.0,M,"sciatic problem/ sciatic nerve going down my leg; feel pain that goes down his right leg/ bum down to his foot; I have a tough time walking; This is a spontaneous report from a contactable consumer (patient). A 92-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL92U3) solution for injection, via an unspecified route of administration on 21Jan2021 at a single dose for Covid-19 immunization. Medical history was reported as none. Concomitant medications included different pills. The patient called and would like to know if his sciatic problem in his left side was related to the Covid vaccine he received. After he got his shot he went down and parked for 15 minutes and then he went to ride home, and when he got out of the car he had sciatic nerve going down his leg on 21Jan2021. He can't seem to get rid of it and now he was just wondering what would have done that. He felt the pain that goes down his right leg/bum down to his foot, he had a tough time walking on 21Jan2021. Patient was taking different pills and stated, ""nothing real serious but this is little bit serious"". Treatment for the events: patient tried different saps and stuffs to put on his leg and he had also taken Tylenol arthritis pill. Outcome of the events was unknown. No follow-up activities are needed. No further information is expected. Information regarding the lot/batch number has been obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/21/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Gait disturbance', 'Pain in extremity', 'Sciatica']",1,PFIZER\BIONTECH, 1061972,KY,46.0,F,"Increased heart rate. Over 100 when resting; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: El9261) via an unspecified route of administration, on the left arm, on 22Jan2021 at 15:30 PM (at the age of 46 years) at a single dose for COVID-19 immunization. Medical history included Hashimoto's disease. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included liothyronine (LIOTHYRONINE), thyroid (ARMOUR THYROID). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Jan2021 at 16:30 PM, the patient experienced increased heart rate, over 100 when resting. The event was reported as non-serious. The patient had lab tests which included heart rate: over 100 on 22Jan2021. No treatment was given. The clinical outcome of the increased heart rate, over 100 when resting was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,PVT,LIOTHYRONINE; ARMOUR THYROID,,Medical History/Concurrent Conditions: Hashimoto's disease,,,"['Heart rate', 'Heart rate increased']",1,PFIZER\BIONTECH, 1061973,NM,52.0,F,"Increased pain with deep breaths; dizziness 6/10 and ""different""; a sharp pain/Increased pain; This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3302), intramuscular from 25Jan2021 16:00 at SINGLE DOSE in left arm for COVID-19 immunization. Medical history included allergic rhinitis, depression, hypertension, and lupus. Concomitant medications included salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), bupropion, hydroxychloroquine, olmesartan, colecalciferol, folate sodium, magnesium, omega-3 fatty acids, pyridoxine hydrochloride, vitamin b12 nos, vitamin e nos (SUPER OMEGA 3 [COLECALCIFEROL;FOLATE SODIUM;MAGNESIUM;OMEGA-3 FATTY ACIDS;PYRIDOXINE HYDROCHLORIDE;VITAMIN B12 NOS;VITAMIN E NOS]), curcuma longa rhizome (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]). The patient previously took codeine and experienced Known allergies, hives, itching, throat swells. The patient had first dose of BNT162B2 on 04Jan2021 15:15 at 52-years-old. It was reported that the patient experienced usual chest pressure related to lupus condition but after getting Covid vaccine it is now a on 25Jan2021 16:00, sharp pain, reports dizziness 6/10 and ""different"". Increased pain with deep breaths. denies nausea. Taken to ED (Emergency department) with RR. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included investigation: 6/10 on 25Jan2021, respiratory rate: unknown results on 25Jan2021. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/25/2021,0.0,PVT,ALBUTEROL [SALBUTAMOL SULFATE]; BUPROPION; HYDROXYCHLOROQUINE; OLMESARTAN; SUPER OMEGA 3 [COLECALCIFEROL;FOLATE SODIUM;MAGNESIUM;OMEGA-3 FATTY ACIDS;PYRIDOXINE HYDROCHLORIDE;V; TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME],,Medical History/Concurrent Conditions: Allergic rhinitis; Depression; Hypertension; Lupus syndrome,,,"['Dizziness', 'Investigation', 'Pain', 'Painful respiration', 'Respiratory rate']",2,PFIZER\BIONTECH,OT 1061974,,57.0,F,"side effect of a metallic taste in her mouth, back of throat, and nose; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced side effect of a metallic taste in her mouth, back of throat, and nose on 27Jan2021. The patient wants more information on this. Outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,,,,,,['Dysgeusia'],UNK,PFIZER\BIONTECH, 1061975,IN,72.0,F,"chest pain; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262) on her left arm, via an unspecified route of administration on 25Jan2021 at a single dose for covid-19 immunization. Medical history included Open heart surgery in 2006. There were no concomitant medications. It was reported that the patient had the COVID shot on the 25Jan2021, she and her husband, and she sat for 20 minutes, everything was fine, she got in the car, and was going down the road, she had chest pains, then it eased up and it stopped then probably another 25 to 30 minutes later is started again. The chest pains started probably a half hour after the shot. They went away, then she had it three times that day, and once today, and once yesterday, so they are ongoing. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Open heart surgery,,,['Chest pain'],UNK,PFIZER\BIONTECH, 1061976,CA,65.0,F,"I have been diagnosed with Afib but do not have daily episodes. Within 2 hours after receiving the vaccine I began to have regular episodes throughout the day and night and they have continued.; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELB982), via an unspecified route of administration on the left arm on 25Jan2021 11:15 at a single dose for COVID-19 immunization. Medical history included heart disease, hypothyroidism and Afib (Atrial fibrillation). The patient is not pregnant. Concomitant medication included levothyroxine, acetylsalicylic acid (BABY ASPIRIN) and cetirizine hydrochloride (ZYRTEC). It was reported that the patient was diagnosed with Afib but do not have daily episodes. Within 2 hours after receiving the vaccine (25Jan2021 13:30), the patient began to have regular episodes throughout the day and night and they have continued. Her cardiologist is out of town and was referred by his office to go to the ER if she felt she should. The patient do not think it is bad enough to go to the ER so she is just monitoring on her Apple Watch. No treatment was received for the event. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,UNK,LEVOTHYROXINE; BABY ASPIRIN; ZYRTEC,,"Medical History/Concurrent Conditions: AFib; Heart disease, unspecified; Hypothyroidism",,,['Atrial fibrillation'],1,PFIZER\BIONTECH, 1061977,,,M,"left arm was swelling/his arm swelled up all this week; had some shoulder pain/shoulder hurt all week; his arm has a mustard looking color about 3- 4 inches long on his left arm which is where the vaccine was injected; it is making it kind of hard to sleep; This is a spontaneous report from a contactable consumer (patient himself). An 83-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration in the left arm on 18Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that a couple of days after the administration of the first dose of the Pfizer COVID vaccine, on an unspecified date, he noticed his left arm was swelling and he had some shoulder pain. His arm swelled up and his shoulder hurt all that week and it started to go down. According to him, it was also kind of making it hard to sleep on an unspecified date. He also stated that his arm had a mustard looking color about 3- 4 inches long (also reported as across) on his left arm which was where the vaccine was injected and he can see where the injection was. The patient would like to know if this was normal and if he has to worry about it. He was scheduled for the second dose on 12Feb2021 and he will get the second dose on the right arm at that time. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,,,UNK,,,,,,"['Arthralgia', 'Insomnia', 'Peripheral swelling', 'Vaccination site discolouration']",1,PFIZER\BIONTECH, 1061978,TX,61.0,M,"he was not comfortable; allergic reaction; dizziness; feeling a lot of pressure in his head like his ""brain wanted to pop out of his head""/ his brain wanted to swell up; felt like he was going to lose his mind / go crazy; fever; headache is recurring- worse at bedtime; almost passed out; This is a spontaneous report from a contactable consumer reporting for himself. A 61-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL9621), intramuscular on the left arm on 22Jan2021 (reported as 07:45 to 08:00) at a SINGLE DOSE for prevent COVID, at 61 years old. Medical history included triple bypass surgery from an unknown date. There were no concomitant medications. The patient previously took morphine and experienced the same thing with his brain, almost identical to what he was experiencing after the COVID vaccine. He reported that the first time he received morphine it was fine and then he got a shot of morphine and he experienced the pressure on his brain after receiving morphine, about 5 or 6 years before reporting time. He stated it was almost the same reaction. He was given a shot of Demerol (he was not sure if it was Demerol) to counteract it. History of all previous immunization reported as none. No additional vaccines administered on the same date. No prior vaccinations within 4 weeks. The patient reported he experienced an ""allergic reaction""/ bad reaction to his first dose of BNT162B2 on 22Jan2021. His symptoms included dizziness as soon as he got the vaccine, got dizzy right off the bat, still dizzy, very little; feeling a lot of pressure in his head like his ""brain wanted to pop out of his head""/ his brain wanted to swell up; felt like he was going to lose his mind / go crazy; fever; headache is recurring- worse at bedtime. Symptoms (unspecified which) reported as recurring and are notably worse at bedtime. Patient is hesitant to receive the second dose. The patient stated he just went to sleep and prayed and then when he woke the next day, at night it did it again. At night it comes and goes, and he still has it happen but not like the first time. He tried to describe that he was washing his hands and he almost passed out like on an unspecified date in Jan2021, he was going to lose his mind. Last night he went to bed no problem, he felt a little pressure on his brain, stated it is hard to describe, it was not a good feeling. He was running a fever. Last night he had a slight fever, like it was going away. He was not able to drive when this was happening and today was the first day he could drive and he was not comfortable (27Jan2021). The patient declined any treatment. He already talked to his doctor and was told to call Pfizer. He asked if he was to get the second shot, is there something he could to take to make that feeling go away or counteract it. No relevant tests were reported. Events did not require a visit to the emergency room nor physician office. The outcome of the events, allergic reaction, headache is recurring- worse at bedtime, almost passed out and he was not comfortable was unknown. Outcome of the events dizziness, ""feeling a lot of pressure in his head like his brain wanted to pop out of his head/ his brain wanted to swell up"", felt like he was going to lose his mind / go crazy, and fever was reported as recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/01/2021,,PVT,,,Medical History/Concurrent Conditions: Bypass surgery,,,"['Discomfort', 'Dizziness', 'Feeling abnormal', 'Head discomfort', 'Headache', 'Hypersensitivity', 'Presyncope', 'Pyrexia']",1,PFIZER\BIONTECH,OT 1061979,CA,83.0,F,"bleeding in her mouth/bleeding from her mouth and nose; nasal bleeding/bleeding from her mouth and nose; when she spit blood come out; bruise; This is a spontaneous report from a contactable nurse. This Nurse reported for an 83-year-old female patient (mother). An 83-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation and warfarin (COUMADIN) via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose as blood thinner. Patient's medical history and concomitant medications were not reported. On an unknown date, caller asked if the patient (mother) should receive the second dose of the vaccine if she has bleeding in her mouth at night and nasal bleeding. Reporter mentioned that the patient takes Coumadin but has never had bleeding until now. It was reported that the patient had a normal INR prior to getting the vaccine but started having bleeding from her mouth and nose after she received the first vaccine dose. Patient's after having the vaccine was 3.1 The reporter asked for more information about patient's on blood thinner. Reporter also asked for information about if the second vaccine dose is given more than 21 days apart. It was then clarified that patient got the Covid vaccine on Saturday (unspecified date) at 1:00. Reporter stated that the patient had bleeding in her mouth that night. Stated that on Monday (unspecified date) patient had another bleeding during the night and when she spit blood come out. Reporter called just now and mentioned that patient had nasal bleeding. Stated that the patient never had bleeding before and that patient had been on blood thinners for years. Stated that sometimes, the patient had bruise. It was also reported that patient's INR was 3.1 before the Covid vaccine which is in acceptable range. Reporter mentioned that she is not sure if patient should have the second dose. Stated that she is on a low dose of warfarin. Outcome of the events was unknown. Information on Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Contusion', 'Epistaxis', 'Haemoptysis', 'International normalised ratio', 'Mouth haemorrhage']",UNK,UNKNOWN MANUFACTURER, 1061980,WA,,F,"Lip blistering; Severe headache; body aches; This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration on the left arm on 19Jan2021 at a single dose for COVID-19 immunization. Medical history included high blood pressure and allergies penicillin. The patient is not pregnant. Concomitant medication included felodipine and losartan. The patient received the first dose of BNT162B2 on 30Dec2020 06:30, lot number: EL1283 for COVID-19 immunization. The patient experienced lip blistering, severe headache and body aches on 20Jan2021 15:00. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/20/2021,1.0,PVT,FELODIPINE; LOSARTAN,,Medical History/Concurrent Conditions: Hypertension; Penicillin allergy,,,"['Headache', 'Lip blister', 'Pain']",2,PFIZER\BIONTECH, 1061981,CT,40.0,F,"felt a little dizzy; felt a wave of heat from my head to my feet; my heartrate elevated; blood pressure as 132/90; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3247 and expiration date not provided), intramuscular in the right arm on 27Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included asthma and Seasonal Allergies. The patient is not pregnant. The patient had no known allergies. The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), fexofenadine hydrochloride (ALLEGRA), and budesonide, formoterol fumarate (SIMBICORT TURBUHALER). After receiving the vaccine on 27Jan2021 09:30, the patient walked to the waiting room, sat down and felt a little dizzy, then felt a wave of heat from her head to her feet and her heart rate elevated. This lasted for the first ~5 minutes immediately receiving the vaccine, then completely subsided. From the firefighter's report: blood pressure as 132/90 and pulse of 76. Treatment was not provided in response to the events. The outcome of the events was recovered on 27Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,WRK,ZOLOFT; ALLEGRA; SIMBICORT TURBUHALER,,Medical History/Concurrent Conditions: Asthma; Seasonal allergy,,,"['Blood pressure measurement', 'Dizziness', 'Feeling hot', 'Heart rate', 'Heart rate increased', 'Hypertension']",1,PFIZER\BIONTECH,OT 1061982,AR,55.0,F,"sore arm from shoulder to finger tips barely able to move it; sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection; about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of paiin where injection was given; hardness where injection was given; slight headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3302, expiry date not reported), via an unspecified route of administration on 26Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included gastric bypass on an unknown date, pseudotumor cerebri (no attacks in over 4 years) from an unknown date to an unspecified date. Concomitant medication included cefprozil (CEFZIL), cetirizine hydrochloride (ZYRTEC), lisinopril. The patient previously took codeine and fluoride [sodium fluoride] and experienced allergies. The patient experienced slight headache on 26Jan2021 14:00, sore arm from shoulder to finger tips barely able to move it on 27Jan2021 05:00, sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection on 27Jan2021 05:00, about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of pain where injection was given on 27Jan2021 05:00, hardness where injection was given on 27Jan2021 05:00. The patient reported that hey had slight headache an hour after injection which went away a couple hours later. On morning after injection they work at 5am with sore arm from shoulder to finger tips barely able to move it. At 8:30 they got up and the pain was still pretty intense but read they needed to move it around started to do that and about an hour later the pain was just in the shoulder and site of injection. Hours later it is still a grapefruit size area of pain and hardness where injection was given. The patient recovered from slight headache on 26Jan2021, was recovering from pain in extremity, shoulder pain, vaccination site pain and vaccination site induration.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,OTH,CEFZIL; ZYRTEC; LISINOPRIL,,Medical History/Concurrent Conditions: Gastric bypass; Pseudotumor cerebri (pseudotumor cerebri (no attacks in over 4 years)),,,"['Arthralgia', 'Headache', 'Pain in extremity', 'Vaccination site induration', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1061983,,,M,"had my antibodies tested yesterday and I don't have any; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received second dose of BNT162B2 (Lot/batch number and expiry date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported It was reported that the patient received the 2nd Pfizer covid vaccine 15 days ago, he had his antibodies tested yesterday and he doesn't have any. This is not related to efficacy, it's more related to not developing antibodies. It's not apart of your clinical trial study, this is more related to the developing of antibodies. He asked if there any information related to not developing antibodies. The patient underwent lab tests and procedures which included Covid-19 antibody test: negative (don't have any) on an unknown date. The outcome of the event was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PVT,,,,,,"['SARS-CoV-2 antibody test', 'SARS-CoV-2 antibody test negative']",2,PFIZER\BIONTECH, 1061984,FL,70.0,M,"sharp lower back pain; pain going down his right leg; feels almost like a pinched nerve; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283 and expiry date: unknown), via an unspecified route of administration on the left arm, on 13Jan2021 11:00 at a single dose for COVID-19 immunization. There were no medical histories. The patient's concomitant medications were not reported. Patient had been having side effects such as sharp lower back pain going down his right leg on late thursday (14Jan2021) afternoon, but probably the morning of 15Jan2021, which he never had before. It feels almost like a pinched nerve, but hasn't done anything to exert himself since he received the COVID-19 Vaccine. He did not cause this pain himself and wanted to know if anybody else has reported this. Outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/14/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Back pain', 'Nerve compression', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 1061985,FL,71.0,M,"Muscle/joint pain; Muscle/joint pain; 101.6 temp; chills; sicky feeling, stayed in bed 36 hours; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9263; expiry date: unknown) via an unspecified route of administration in the left arm, on 22Jan2021, at 15:45, at a single dose, for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications included hydrochlorothiazide, colecalciferol (VIT D3), cetirizine hydrochloride (ZYRTEC), and azelastine hcl. The patient previously took codeine and experienced allergies (itchy skin). The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Place of vaccination was reported as ""other"". On 23Jan2021, at 12:00 AM, the patient experienced muscle/joint pain, 101.6 temperature (temp), chills, and sicky feeling (stayed in bed for 36 hours). The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/23/2021,1.0,PUB,HYDROCHLOROTHIAZIDE; VIT D3; ZYRTEC; AZELASTINE HCL,,,,,"['Arthralgia', 'Body temperature', 'Chills', 'Malaise', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH, 1061986,AL,77.0,M,"Rash- left calf, ankle to knee; Received BNT162B2 with medical history of Psoriatic arthritis; Received BNT162B2 with medical history of Psoriatic arthritis; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EJ1686), via an unspecified route of administration in the left arm on 20Jan2021 10:15 at SINGLE DOSE for Covid-19 immunisation. Medical history included type 2 Diabetic, Psoriatic arthritis and had heart disorder, allergic to sulfa drugs. He did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included warfarin, sitagliptin phosphate, aspirin (acetylsalicylic acid). The patient experienced rash in the left calf, ankle to knee on 22Jan2021 08:00 (no treatment). The outcome of event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,PUB,WARFARIN; JANUVIA [SITAGLIPTIN PHOSPHATE]; ASPIRIN [ACETYLSALICYLIC ACID],,"Medical History/Concurrent Conditions: Heart disease, unspecified; Psoriatic arthritis; Sulfonamide allergy; Type 2 diabetes mellitus",,,"['Off label use', 'Product use issue', 'Rash']",1,PFIZER\BIONTECH, 1061987,FL,91.0,F,"a mass on my mom chest above her left breast; This is a spontaneous report from a contactable consumer reporting for his/her mother. A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration in the left arm on 28Dec2020 at a single dose for covid-19 immunization at a nursing home/senior living facility. Medical history included chronic obstructive pulmonary disease (COPD) and congestive heart failure. The patient has no allergies to medications, food, or other products. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), hydrocodone bitartrate, paracetamol (NORCO), mirtazapine (REMERON), cranberry, cholesterol, blood pressure meds, and stool softer. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 28Dec2020, the patient (reporter's mother) had the first shot in her left arm. On Wednesday, 30Dec2020, the reporter received a phone call from the institute informing of a mass on the patient's chest above her left breast which started on 28Dec2020. The reporter took pictures and felt it which is hard as a rock. The patient had a doctor or other healthcare professional office/clinic visit. No treatment was given. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination via nasal swab on 28Dec2020 which was negative. The outcome of the event was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,SEN,BABY ASPIRIN; NORCO; REMERON; CRANBERRY; CHOLESTEROL,,Medical History/Concurrent Conditions: Congestive heart failure; COPD,,,"['Mass', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1061988,PA,26.0,F,"Swollen Lymph nodes following second dose x five days; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular at the left arm on 21Jan2021 09:45 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has previously been vaccinated with the first dose of BNT162B2 (lot number: Pfizer 1284) on 30Dec2020 11:00 at the age of 26-year-old, intramuscular at the left arm for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient experienced swollen Lymph nodes following second dose for five days, large lump underneath left armpit expanding into left breast formed and caused limited ROM, immense pain, and bruising on 21Jan2021. The patient did not receive any treatment for the events. The patient has recovered from the event swollen lymph nodes on 26Jan2021 and recovered on an unspecified date for the rest of the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,PVT,,,,,,"['Axillary mass', 'Breast mass', 'Contusion', 'Joint range of motion decreased', 'Lymphadenopathy', 'Pain']",2,PFIZER\BIONTECH,OT 1061989,KY,37.0,F,"Hives; itchy rash on her upper arm of the injection site; rash across her shoulder and both her chest and back and bottom of neck/it spread across her shoulder to right side of her chest, neck and upper right part of her back.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9261, exp date not reported), via an unspecified route of administration (anatomical location: arm right) on 21Jan2021 10:45 given to protect against the virus (COVID-19 immunisation). Vaccination Facility Type: Hospital. Vaccine was not administered at military facility. Medical history included immediate, severe allergic reaction penicillin when she was a kid and she hadn't had it since. The patient had no other medical history and family medical history relevant to adverse event. The patient's concomitant medications were not reported. Patient had no other vaccines given that day or 4 weeks prior. No problems with vaccines in past. The patient was looking for guidance about getting the second dose of the Pfizer Covid vaccine. Had the first dose on 21Jan2021 (Thursday) and had no reaction until 24Jan2021, 3 days later (Sunday). That night she developed what she believed waas hives, an itchy rash on her upper arm of the injection site that spread across her shoulder and both her chest and back and there was also a rash at the bottom of her neck. The hives were still there the day of reporting and been there since. Patient heard that when you have a severe allergic reaction to medicines in past it could be an indication. States she was not seen at the emergency room or at the doctor's office, she only called the doctor's office. They recommended her not to get the second dose, but she wanted to be sure and wanted more information. Relevant tests were not done. Patient would like to know if she should get the second dose of the covid vaccine after the reaction she experienced post 1st dose. The outcome of events was not recovered (ongoing).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/24/2021,3.0,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy (when she was a kid and she hadn't had it since),,,"['Rash', 'Rash pruritic', 'Urticaria']",1,PFIZER\BIONTECH, 1061990,MI,65.0,F,"Started with itching on left neck; swelling below left eye; hands were swelling; This is a spontaneous report from a contactable consumer (patient) reported that a 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 27Jan2021 14:30 at a single dose for covid-19 immunization. The vaccine was administered at the pharmacy. Patient was not pregnant at the time of vaccination. Medical history included sarcoidosis and hypertension both from an unknown date, and one unknown anaphylaxis a year ago (2020). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amlodipine besylate. On 27Jan2021 16:30, it was started with itching on left neck, then swelling below left eye and hands were swelling. The patient was concerned enough she took a Benadryl. The events result in doctor or other healthcare professional office/clinic visit. Treatment received for the events was Benadryl. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,PHM,AMLODIPINE BESYLATE,,Medical History/Concurrent Conditions: Anaphylaxis (1 unknown anaphylaxis a year ago); Hypertension; Sarcoidosis,,,"['Periorbital swelling', 'Peripheral swelling', 'Pruritus']",1,PFIZER\BIONTECH, 1061991,KS,51.0,F,"3 days of body pain; muscle aches all over body and face; muscle aches all over body and face; other vaccine same date; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; dose 1) via an unspecified route of administration on 22Jan2021 at 09:00 (at the age of 51-years-old) as a single dose in the left arm for COVID-19. The patient had no medical history. She was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not take any concomitant medications. The patient received another unspecified vaccine on 22Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient previously took penicillin from an unspecified date for an unspecified indication and experienced allergy. On 23Jan2021 at 06:00, the patient experienced 3 days of body pain and muscle aches all over body and face. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The outcome of 3 days of body pain and muscle aches all over body and face was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,WRK,,,"Medical History/Concurrent Conditions: Penicillin allergy (Allergies to medications, food, or other products:penecillin)",,,"['Facial pain', 'Myalgia', 'Pain', 'Product use issue']",1,PFIZER\BIONTECH, 1061992,OH,67.0,M,"he has polycythemia ulcers and notices that they are acting up; he has polycythemia ulcers and notices that they are acting up; he has polycythemia ulcers/ they are acting up/he means that it feels like indigestion and its real bad, it hurts, like a pit in the stomach that hurts; runny nose; The Runny nose was noticed on one side and was initially congested; This is a spontaneous report from a contactable consumer reporting for himself. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL9261), via an unspecified route of administration (arm left) on 24Jan2021 03:30 at SINGLE DOSE for COVID-19 immunisation, at 67 years old. Medical history included type 2 diabetes mellitus from an unknown date, stent placement from an unknown date, and ongoing polycythaemia ulcer from an unspecified date. Concomitant medications included unspecified normal medicines, diabetic medicine, ulcer medicine, and vitamins. Patient wanted to know if a runny nose after receiving the Covid injection was common and how long does it last. The patient stated that he received the first dose of the vaccine on Sunday and on 27Jan2021 he experienced a runny nose. The patient also asked how long adverse reactions happens and how many days after the vaccine. The patient has polycythemia ulcers and notices that they are acting up. He got the shot on 24Jan2021, 03:30 (Sunday), and the Polycythemia Ulcers are acting up as well as he has a runny nose. The Runny nose was noticed on one side and was initially congested, he then took his normal vitamins and an hour later his nose started to run, this all occurred on reporting time, 27Jan2021. The Ulcers acting up was also on 27Jan2021. The patient was queried when his Polycythemia was diagnosed, he stated that he was actually in the process of it being diagnosed, he has basically had all the tests that confirms, there's one more left, but he has been doing blood draws and it is almost confirmed. He was just asking his question because he noticed that this did not occur the same day as getting the vaccine and it came later. For the runny nose he took a ZYRTEC decongestant and it worked for a while but did not hold it off, however it is not like a faucet like it was earlier, it was better now. He described his Polycythemia Ulcers being located internally on the heart and esophagus, being at the lower part of the stomach. By his ulcers acting up he means that it feels like indigestion and its real bad, it hurts, he has not had food, it feels like when they take a pint of his blood every month, to get him low in iron, it was like a pit in the stomach that hurts. He took famotidine. He does not know if he should have taken it or not, but he saw there was some problem with somebody in (state name) with platelets. He had the Famotidine about half an hour before reporting time. The patient was asked to clarify what he meant about somebody in (state name), he stated that he was looking online and saw something about a doctor died because of the Low platelet count. The patient was aware that famotidine lowers platelets and was just asking. The patient stated that he was not saying the doctor took famotidine, but his blood was not getting clotting. Regarding Covid Vaccine Card, from it he read PF17c12 but does not know what this is for, there was an expiry but he cannot read the writing. Outcome of the events was recovering. The reporter considered the events as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/27/2021,3.0,UNK,,"Polycythemia (located internally on the heart and esophagus, being at the lower part of the stomach); Ulcer (located internally on the heart and esophagus, being at the lower part of the stomach)",Medical History/Concurrent Conditions: Blood test; Stent placement (Verbatim: Stent placement); Type 2 diabetes mellitus (Verbatim: diabetes type 2),,,"['Blood test', 'Condition aggravated', 'Laboratory test', 'Nasal congestion', 'Polycythaemia', 'Rhinorrhoea', 'Ulcer']",1,PFIZER\BIONTECH, 1061993,,,M,"chills; high temperature/fever 38 C; feeling tired; headache; This is a spontaneous report from a contactable consumer (the patient). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 26Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine yesterday 26Jan2021. He experienced chills, high temperature/fever 38 C, feeling tired, and headache the day after (27Jan2021). The patient took paracetamol (TYLENOL) to manage the symptoms. He asked if these are normal side effects and was looking for recommendations. The clinical outcome of chills, high temperature/fever 38 C, feeling tired, and headache was unknown. Information about Lot/batch number requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/27/2021,1.0,UNK,,,,,,"['Body temperature', 'Chills', 'Fatigue', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH, 1061994,CT,,F,"very sore arm; very uncomfortable; This is a spontaneous report from a contactable consumer. An adult female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 26Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient is not pregnant at the time of vaccination. On 27Jan2021, the patient experienced very sore arm- had to have vaccine in dominant arm. The patient added that after 24 hours she was very uncomfortable. The events were assessed non-serious. The patient has not been diagnosed with Covid prior to vaccination and has not tested positive since the vaccination. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/27/2021,1.0,WRK,,,,,,"['Discomfort', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 1061995,FL,36.0,F,"Burning right arm; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 11Jan2021 09:30 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. On 15Jan2021, the patient experienced burning right arm and fatigue. Treatment was received for the adverse events which included MRI, NCS, Blood work. The events resulted to a doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/15/2021,4.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Burning sensation', 'Fatigue']",1,PFIZER\BIONTECH, 1061996,NY,70.0,F,"nervousness; slight swelling/tingling in lips; slight swelling/tingling in lips; dizziness; like she has a cough in her throat; swelling and soreness of her arm; swelling and soreness of her arm; Tightness in her jaw; Numbness in hand; difficulty swallowing; taste in her mouth; dry mouth; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, unknown expiration), via an unspecified route of administration in left arm on 26Jan2021 at 08:30 AM at a single dose for COVID-19 immunization in a clinic. Medical history included ongoing underactive thyroid, cataract surgery on 14Oct2020 and on 28Oct2020, and cholesterol (abnormal). Concomitant medications included ongoing levothyroxine for underactive thyroid and ongoing rosuvastatin calcium for cholesterol. The patient experienced nervousness, slight swelling/tingling in lips, dizziness, like she has a cough in her throat, swelling and soreness of her arm, tightness in her jaw, numbness in hand on 26Jan2021. The patient also had difficulty swallowing, had taste in her mouth, and dry mouth in Jan2021. The patient on the line calling about the COVID-19 vaccine. She got the shot yesterday (26Jan2021) and was calling to report on the reaction that occurred. She initially stated she had slight swelling/tingling in lips, difficulty swallowing, numbness in hands, jaws became tight, and nervousness which she is still experiencing. She mentioned she took benadryl. She was wondering if she should go and get the second shot. The patient first experienced dizziness which lasted for a second and this occurred while waiting in the lobby for observation after getting the vaccine. Slight swelling and tingling in lips were noticed two minutes after the dizziness. It felt like a tingle sensation. She clarified she does not necessarily have difficulty swallowing. It was not so much she could not swallow, but it was like she has a cough in her throat. It feels like she could cough but would need to keep swallowing and drinking water. Once she got the shot it caused her to get a taste in her mouth. The feeling like a cough in her throat has gone away, but now she feels nervousness, dry mouth, and she still has that taste in her mouth from getting the shot. She had swelling and soreness of her arm, but she knew that was to be expected which started an hour after getting the vaccine. Tightness in her jaw was noticed an hour after getting the vaccine. The numbness in hand started at the same time as the tightness of her jaw. Her left hand is what went numb, and she had the vaccine administered in her left arm. The nervousness is getting better, but she felt very nervous. She also mentioned she has thyroid problems and is not sure if this has anything to do with it. She had this nervousness feeling 2 hours after getting the shot. Patient is scheduled to get the second vaccine on 18Feb2021. Benadryl has helped a lot. The patient has no additional vaccines administered on the same date and has no prior vaccination within four weeks. The events did not require emergency room and physician office visit. Vaccine was not administered in a military facility. The patient was recovering from events nervousness, slight swelling/tingling in lips, swelling and soreness of her arm, tightness in her jaw, and numbness in hand; recovered from dizziness on 26Jan2021; recovered from event ""like she has a cough in her throat"" on unspecified date; not yet recovered from event ""taste in her mouth""; while unknown outcome for the remaining events. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/01/2021,,OTH,LEVOTHYROXINE; ROSUVASTATIN CALCIUM,Thyroid function decreased,Medical History/Concurrent Conditions: Blood cholesterol abnormal; Cataract operation,,,"['Dizziness', 'Dry mouth', 'Dysphagia', 'Hypoaesthesia', 'Lip swelling', 'Muscle tightness', 'Nervousness', 'Pain in extremity', 'Paraesthesia oral', 'Peripheral swelling', 'Sensation of foreign body', 'Taste disorder']",1,PFIZER\BIONTECH, 1061997,FL,65.0,F,"Body aches/random shooting pains throughout body; Fatigue; Upper back pain; abdominal pain; severe coughing that evening; headache; very sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EK9231), via an unspecified route of administration on the right arm on 14Jan2021 08:30 at a single dose for COVID-19 immunization at a hospital. Medical history included very chemically sensitive and drug sensitive, interstitial lung disease, and interstitial cystitis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included vitamin D, zinc, and an unspecified thyroid medication. On 14Jan2021 13:00, the patient experienced body aches, fatigue, random shooting pains throughout body, upper back pain, abdominal pain, severe coughing that evening, headache, and very sore arm. Treatment included self prescribed paracetamol (TYLENOL). Since the vaccination, the patient has not been tested for COVID-19. The patient has not yet recovered from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,PVT,VITAMIN D NOS; ZINC,,Medical History/Concurrent Conditions: Cystitis interstitial; Drug hypersensitivity; Hypersensitivity; Interstitial lung disease,,,"['Abdominal pain', 'Back pain', 'Cough', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 1061998,NV,39.0,F,"Itchy neck, arms, lower half of face; Hives on both arms.; Burning headache; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL8982), via an unspecified route of administration in the right arm on 27Jan2021 08:45 at a single dose for covid-19 immunization. Medical history included hypothyroid, allergies to nausea medication and COVID 19. Concomitant medication included levothyroxine. On 27Jan2021 12:00, the patient experienced itchy neck, arms, lower half of face., hives on both arms and burning headache. The patient did not receive treatment for the events. The events were assessed non-serious. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,SCH,LEVOTHYROXINE,,Medical History/Concurrent Conditions: COVID-19; Drug allergy (known allergies: Nausea medication); Hypothyroidism,,,"['Headache', 'Pruritus', 'Urticaria']",1,PFIZER\BIONTECH, 1061999,NY,25.0,F,"Chills, fever, muscle aches and nauseous. Vomited twice; Chills, fever, muscle aches and nauseous. Vomited twice; Chills, fever, muscle aches and nauseous. Vomited twice; Chills, fever, muscle aches and nauseous. Vomited twice; Chills, fever, muscle aches and nauseous. Vomited twice; This is a spontaneous report from a contactable Other Health Professional that reported for herself. A 25 year old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 on 26Jan2021 09:00, as single dose (at the age of 25 years) via unspecified route in left arm for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication includes fluoxetine (FLUOXETINE). Historical vaccine included dose one of BNT162B2, lot number EL0142, on 07Jan2021 11:30, unspecified route, vaccine location Left arm for COVID-19 immunization. The patient did not have Allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 at 20:00 the patient experienced chills, fever, muscle aches and nauseous. The patient vomited twice. No treatment was given. The patient is recovering from Chills, fever, muscle aches and nauseous as well as vomited twice. The case was reported as non-serious by the reporter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,PVT,FLUOXETINE,,,,,"['Body temperature', 'Chills', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH, 1062000,OH,53.0,F,"Rash face and neck; This is a spontaneous report from a contactable Other Health Professional that reported for herself. A 53-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL8982 on 22JAN2021 15:00, as single dose (at the age of 53 years) via unspecified route in left arm for COVID-19 immunisation. The patient medical history was none. Concomitant medication was not reported. The patient was not pregnant at the time of vaccination. There were no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. On 26Jan2021 at 06:00 the patient experienced Rash face and neck. The patient received treatment (Benadryl and aloe). The outcome rash face and neck are recovering. The case was reported as non-serious by the reporter.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/26/2021,4.0,PUB,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Rash'],1,PFIZER\BIONTECH, 1062001,FL,61.0,F,"Eyes bloodshot; Rash over entire body...arms, legs, abdomen, back, neck; dose number= 1, administration date= 06Jan2021/dose number= 2, administration date=20Jan2021; dose number= 1, administration date= 06Jan2021/dose number= 2, administration date=20Jan2021; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at the left arm on 20Jan2021 07:45 at single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (WP THYROID), methocarbamol, and paracetamol (TYLENOL). The patient has known allergies to cefalexin (KEFLEX) and statins. The patient was previously vaccinated with the first dose of BNT162B2 on 06Jan2021 07:45 at the age of 61-year-old intramuscular at the right arm for COVID-19 immunization. The patient experiences rash over entire body, arms, legs, abdomen, back, neck, not on the face yet and eyes bloodshot; symptoms appeared over 8-hour period beginning at 7 am on 26Jan2021. The patient did not receive any treatment for the events. The outcome of the events rash over entire body and eye bloodshot were not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,PVT,WP THYROID; METHOCARBAMOL; TYLENOL,,Medical History/Concurrent Conditions: Hypothyroidism,,,"['Inappropriate schedule of product administration', 'Ocular hyperaemia', 'Off label use', 'Rash']",2,PFIZER\BIONTECH,OT 1062002,NC,23.0,F,"fingers were numb and tingling; 12 hours post 2nd dose the left side of patient face and left ear were numb as well as both arms and both legs/fingers were numb and tingling; This is a spontaneous report from a contactable consumer. A 23-year-old female patient (not pregnant) received the second dose of bnt162b2 (BNT162B2 also reported as BIONTECH Covid vaccine, lot EL3247), via an unspecified route of administration in the left arm on 25Jan2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. She received her first dose of bnt162b2 (lot EK9231) on 05Jan2021 in the left arm. On 26Jan2021, the left side of patient's face and left ear were numb as well as both arms and both legs and 800mg of ibuprofen was taken. Next morning (27Jan2021), the numbness in legs gone but the left arm from shoulder to fingers were numb and tingling. The outcome of events was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/26/2021,1.0,PVT,,,,,,"['Hypoaesthesia', 'Paraesthesia']",2,PFIZER\BIONTECH, 1062003,CA,39.0,F,"patient with myelitis transverse received Pfizer Covid 19 vaccine; patient with myelitis transverse received Pfizer Covid 19 vaccine; Paresthesias to bilateral hands to elbows, right foot/leg; brain fog; fatigue; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK-5730; expiration date: unknown) at 39-year-old age of vaccination intramuscularly in the left arm on 26Dec2020 11:30 at a single dose for covid-19 immunization. Medical history included myelitis transverse from 2015 to an unknown date and depression. The patient has no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive other vaccine in four weeks but has other medications in two weeks. It was reported that the patient with myelitis transverse received Pfizer Covid 19 vaccine on 26Dec2020. On Dec2020, the patient had paresthesias to bilateral hands to elbows, right foot/leg with brain fog and fatigue. Symptoms appeared approximately 12-18hrs after injection. There was no treatment receive for the adverse events. The events resolved 48 hours after. The adverse events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab (sars-cov-2 test) with the result of negative on 22Jan2021. The outcome of the events was recovered on Dec2020.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/26/2020,12/01/2020,,PVT,,,Medical History/Concurrent Conditions: Depression; Myelitis transverse,,,"['Fatigue', 'Feeling abnormal', 'Off label use', 'Paraesthesia', 'Product use issue', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1062004,WI,78.0,F,"she has a hearing problem; Constant chills; Cramps; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248) via an unspecified route of administration on 25Jan2021 10:30 on the left arm at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient stated that she did not experience any problems until 27Jan2021 around noon, in which she started experiencing chills, cramps, and diarrhea all afternoon. She would like to know if these reactions have been reported and if they continue to persist, can she take something like Imodium. She didn't have any effect at all from it on Monday or Tuesday, and at noon on 27Jan2021, she had nausea and constant chills and diarrhea, she doesn't think this was a side effect, but wanted to check and see. She was not terribly ill, just uncomfortable, is this something she should be reporting? Stated she has a hearing problem, wished for DSU agent to speak slower. Nausea: was off and on all the time since noon today, it is better, the main thing is diarrhea, and the nausea is connected Constant chills: improving, it came and went all afternoon, she doesn't know if it has gone away, she thinks it is still here, but she is not constantly bothered, it has been periodically since noon today. Diarrhea: better since she has nothing left; nothing was getting worse, she was reporting it because she thought it may be a side effect. Outcome of the events constant chills and nausea was recovering, diarrhea was recovered on an unspecified date while unknown for the other events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/27/2021,2.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Diarrhoea', 'Hypoacusis', 'Muscle spasms', 'Nausea']",1,PFIZER\BIONTECH, 1062005,,67.0,F,"Tongue and throat swelling; Tongue and throat swelling; not able to breathe; right and left sided face swelling; hives from top of head to lower extremities; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tongue and throat swelling and took diphenhydramine (BENADRYL). Patient was also not able to breathe, had right and left sided face swelling, and hives from top of head to lower extremities. Patient reported that the doctor gave her an epi pen. Patient would like to know if she should get second dose. She is scheduled to receive second dose on 28Jan2021 also if she should get a pneumonia vaccine and was instructed to wait 14 days after the Pfizer Biotech Covid-19 vaccine administration. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,,,UNK,,,,,,"['Dyspnoea', 'Pharyngeal swelling', 'Swelling face', 'Swollen tongue', 'Urticaria']",1,PFIZER\BIONTECH, 1062006,MN,53.0,F,"Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, unknown expiration), via an unspecified route of administration in right arm on 19Jan2021 at a single dose for COVID-19 immunization in a workplace clinic. Medical history included hypothyroidism, idiopathic thrombocytopenic purpura (ITP), and previously administered dermal fillers in Jun2020. The patient has no allergies to medications, food, or other products. Concomitant medications included levothyroxine, tamoxifen, and vitamin D. The patient also received her first dose of BNT162B2 (lot number: EJ1685, unknown expiration) for COVID-19 immunization in right arm on 29Dec2020. The patient experienced swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness on 21Jan2021. The patient received steroids and antihistamines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient recovered from the events on unspecified date. The events were assessed as non-serious. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/21/2021,2.0,WRK,LEVOTHYROXINE; TAMOXIFEN; VITAMIN D [VITAMIN D NOS],,Medical History/Concurrent Conditions: Dermal filler injection; Hypothyroidism; Idiopathic thrombocytopenic purpura,,,"['Erythema', 'Eye swelling', 'Pain', 'Swelling face']",2,PFIZER\BIONTECH, 1062007,NY,65.0,F,"Intense Itching and swelling; Intense Itching and swelling; Pain but not severe, moderate; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 3247), via an unspecified route of administration on 18Jan2021 17:30 at a single dose on left arm for COVID-19 immunization. Medical history included itchiness from fake eyelash glue. There were no concomitant medications. The patient previously received flu vaccine for immunization and experienced itchiness. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no any other medications received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. On 20Jan2021, the patient experienced intense itching and swelling and pain but not severe, moderate. The events resulted in visit to emergency room/department or urgent care. The patient was treated with antihistamine for the events. The patient was recovering from the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/20/2021,2.0,UNK,,,Medical History/Concurrent Conditions: Itching,,,"['Pain', 'Pruritus', 'Swelling']",1,PFIZER\BIONTECH, 1062008,CA,22.0,F,"Just a lot of soreness. After 2 hours I began to have a lot of pain; I was even having trouble raising my arm up because of the pain/soreness; I was even having trouble raising my arm up because of the pain/soreness; This is a spontaneous report from a contactable healthcare professional (patient). A 22-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL8982), intramuscular on 21Jan2021 10:00 at single dose (left arm) for covid-19 immunization. The patient medical history was not reported. The patient had no allergies to medications, food or other products and patient was not pregnant. There were no concomitant medications. On 21Jan2021, 12:00, the patient experienced a lot of soreness. After 2 hours, she began to have a lot of pain for the rest of the day. That same night, she was even having trouble raising her arm up because of the pain/soreness, but by the next day the soreness went a lot more down. There was no therapy for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included Sars covid test (Nasal Swab/Rapid Antigen) was negative on 22Jan2021. Outcome of events was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,PUB,,,,,,"['Mobility decreased', 'Pain', 'Pain in extremity', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1062009,FL,76.0,M,"Patchy red skin on both thighs. Slightly itchy.; Patchy red skin on both thighs. Slightly itchy.; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 21Jan2021 at 09:45 at a single dose on left arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced patchy red skin on both thighs, slightly itchy on 21Jan2021. Therapeutic measures were taken as a result of both events (steroid cream). The outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,UNK,,,,,,"['Erythema', 'Pruritus']",UNK,PFIZER\BIONTECH, 1062010,FL,71.0,F,"She started experiencing burning; Rash; Shingles; itching; Headache; Malaise; very tired; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: E13247) via an unspecified route of administration on 19Jan2021 11:30 at a single dose for COVID-19 immunization. Medical history included A-fib. Concomitant medication included apixaban (ELIQUIS). Had COVID-19 Vaccine on 19Jan2021 and everything was fine. Had a headache and a little bit of malaise on 20Jan2021. After two days was ok. On 21Jan2021, broke out in what she thinks was shingles. Not 100% sure if it was a major rash or shingles. Wanted to know if that was a possible side effect. Patient was taking Valaciclovir (VALTREX) for Shingles. Doctor suspected it was shingles, but it was possible she had shingles brewing before the COVID-19 Vaccine or the COVID-19 Vaccine brought the shingles out. Second COVID-19 Vaccine is scheduled for 09Feb2021, patient was scared and afraid of it. Doesn't know what to do. On 20Jan2021 she was very tired and had a headache. Next day was ok. On 21Jan2021 thought she had bug bites. Started itching. Then it began traveling and she realized it was not bug bites. She started experiencing burning. Went to two Urgent Care and her Internist. Was told it was basically shingles. Her internist was on the fence because she just had the COVID-19 Vaccine and wasn't certain. Caller stated it was ironic that she broke out after the vaccine. Caller's internist stated for any rash it would be treated the same with Valtrex. Internist stated chances were the rash was viral so if it's not shingles, would be treated with Valtrex. Rash and Itching: Wasn't very bad on Saturday, 23Jan2021, which was the first time she had someone look at it. On Sunday, 24Jan2021 it was full blown and really blossomed. Was initially treating rash as if it was bug bites. Was applying Benadryl tropical. On Sunday, 24Jan2021, started taking Valtrex. Outcome of the events headache, malaise, fatigue was recovered on n unspecified date, while unknown for the other events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/20/2021,1.0,UNK,ELIQUIS,,Medical History/Concurrent Conditions: AFib,,,"['Burning sensation', 'Fatigue', 'Headache', 'Herpes zoster', 'Malaise', 'Pruritus', 'Rash']",UNK,PFIZER\BIONTECH, 1062011,CA,54.0,M,"heart palpitations; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: Unknown), via an unspecified route of administration at the left arm on 14Jan2021 at a single dose for COVID-19 immunization. The vaccine was administered in a Nursing Home/Senior Living Facility. The patient had no medical history. The patient had not received other vaccine in four weeks. Concomitant medication included erythromycin eye ointment. On the 17Jan2021 4PM, 3 days after being vaccinated the patient got heart palpitations and shortness of breath. This continued until the 23Jan2021 when he stopped having the heart palpitations. However, the shortness of breath has continued. It started out as light shortness of breath and has evolved into moderate. He was not gasping for air but it was uncomfortable enough where he has had to take time off of work. He was seen by a doctor on 27Jan2021. The patient did not receive any treatment for the event. The patient had Nasal swab/ SARs CoV-2 RNA Real time RT PCR on 25Jan2021, and the result was negative. The outcome of the event heart palpitations was recovered on 23Jan2021 and shortness of breath was not recovered. Information on lot number/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/17/2021,3.0,SEN,ERYTHROMYCIN,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dyspnoea', 'Palpitations', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1062012,PA,71.0,M,"slightly sore arm; This is a spontaneous report from a contactable Physician (reporting for himself). A 71-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK9231), via an unspecified route of administration on the left arm, at age 71 years first dose on 04Jan2021, at single dose for COVID-19 vaccination. Medical history included allergic to is seasonal from an unknown date and unknown if ongoing. There were no concomitant medications. On 04Jan2021, the patient had no reaction whatsoever, except a slightly sore arm. The outcome of the event was recovered on an unspecified date in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/04/2021,01/04/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Seasonal allergy,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1062013,CA,45.0,F,"Fatigue; chills; severe aches; headache; nausea; dizziness; This is a spontaneous report from a contactable other healthcare professional. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, lot number: El9262, via an unspecified route of administration on 26Jan2021 15:00 at single dose in the left arm for COVID-19 immunization. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: En1686 on 05Jan2021 15:15 in the left arm. Medical history included allergy to bacteria. Concomitant medication included hydrochlorothiazide, triamterene (MAXZIDE), bupropion, escitalopram oxalate (LEXAPRO), lorazepam and paracetamol (TYLENOL). The patient previously took erythromycin and experienced drug allergies. The patient experienced fatigue, chills, severe aches, everywhere, headache, nausea, dizziness on 26Jan2021 at 22:00. No treatment received for the events. The patient had no prior vaccinations and has not tested for COVID post vaccination. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,PUB,MAXZIDE; BUPROPION; LEXAPRO; LORAZEPAM; TYLENOL,,Medical History/Concurrent Conditions: Bacterial allergy,,,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pain']",2,PFIZER\BIONTECH, 1062014,HI,56.0,F,"Shortness of breath; heart palpitations; Muscle soreness (left arm); overall unwell feeling; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL 9262 and expiration date: unknown), via an unspecified route of administration on the left arm on 27Jan2021 at 09:15 at a single dose for COVID-19 immunization. Medical history included systemic lupus and shrimp allergies. The patient had no other vaccine in four weeks and no other medications in two weeks. There were no concomitant medications. The patient had no COVID prior vaccination. The patient experienced muscle soreness (left arm), heart palpitations, shortness of breath and overall unwell feeling on 27Jan2021 at 10:00, which resulted in a doctor or other healthcare professional office/clinic visit. No treatment was administered for the events. The patient has not tested for COVID post vaccination. The events were resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Lupus syndrome; Shellfish allergy,,,"['Dyspnoea', 'Malaise', 'Myalgia', 'Palpitations']",1,PFIZER\BIONTECH, 1062015,,,F,"pain and a calcium deposit on her shoulder; This is a spontaneous report from a contactable Other HCP (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. and expiry date not reported), via an unspecified route of administration on unspecified date at a single dose for covid-19 immunization. Medical history included calcium deposit on her shoulder. The patient's concomitant medications were not reported. It was reported that she was scheduled to receive her second dose next week. She stated that she has pain and a calcium deposit on her shoulder, in which is on the opposite arm of injection site. She clarified that calcium deposit was there prior to receiving the vaccine and was not related to the vaccine. She stated that she was supposed to go to physical therapy and take steroids but was wondering if she should wait to take the steroids before the second injection. Patient asked if she can use antipyretics before or after vaccination and if there is a delay to receive the second dose, should it be minimum of 3 weeks. She stated she was told 17-22 days the second dose could be given. Outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Calcium deposits,,,['Arthralgia'],1,PFIZER\BIONTECH, 1062016,PA,44.0,M,"Bilateral lower extremity numbness; Tingling; Foot pain; This is a spontaneous report from a contactable nurse (patient). A 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration on the left arm, on 22Dec2020, at single dose, for covid-19 immunization. The patient has no medical history. Concomitant medication included ibuprofen. The patient received the vaccine on 22Dec2020 at the hospital. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 30Dec2020 18:00 sudden onset of bilateral lower extremity numbness, tingling, and foot pain. These continued to present day. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received gabapentin as treatment for these adverse events. At the time of the report, the patient had not recovered from the adverse events. The patient has not been COVID-tested post-vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/30/2020,8.0,PVT,IBUPROFEN,,,,,"['Hypoaesthesia', 'Pain in extremity', 'Paraesthesia']",1,PFIZER\BIONTECH, 1062017,CO,38.0,F,"Breathing difficult; Chills; Body aches; Nauseous with and no appetite; Nauseous with and no appetite; Not feeling too well; One minute she was cold, and then one minute she was hot; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL330Z; Expiration date was not reported) on 26Jan2021 (08:45) at a single dose on the left deltoid (left shoulder area), with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK8176; Expiration date was not reported) on 05Jan2021 (when the patient was 38 years old) for COVID-19 immunization. On 26Jan2021, after the second dose of vaccination, the patient was not feeling too well; had difficulty breathing; had chills; body aches; and was nauseous with no appetite. Along with the chills, the patient further stated that one minute she was cold, and then one minute she was hot on 26Jan2021. The patient did not receive any treatment for the reported events. The outcome of the events was not recovered for 'chills' and 'nauseous with and no appetite'; and was unknown for 'breathing difficult', 'body aches', 'not feeling too well' and 'one minute she was cold, and then one minute she was hot'.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Decreased appetite', 'Dyspnoea', 'Feeling of body temperature change', 'Malaise', 'Nausea', 'Pain']",2,PFIZER\BIONTECH, 1062018,,50.0,F,"tired so quickly; Headache; back pain or the area of the lungs; like my asthma is worse; back pain or the area of the lungs; more like sore on the throat; Short of breath; coughing a few times; Throat pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date unknown) via unspecified route of administration on left arm, on 16Jan2021, at a single dose for COVID-19 immunisation. The patient medical history included asthma. The concomitant medication were not reported. It was reported that on 19Jan2021, she had back pain, or the area of the lungs, headaches, throat pain, like more like sore on the throat, and she wasn't having too much coughing. She reported that initially she felt fine but 3 days later (19Jan2021), she began having shortness of breath ""like my asthma is worse"". She was coughing a few times, sporadically, not like one day coughing like crazy on 19Jan2021. On 26Jan2021, the patient tired so quickly even in her own place doing normal stuff, like cleaning and cooking. The patient used inhaler for short of breath which she usually did not use, like for year, and she saw it had already expired, and she got nervous that she saw it was expired, so she called her doctor to see if she could go, he said he was not receiving patients, all this stuff became so horrible. She tried to go to Urgent Care and they didn't see her, they said she had to go to the hospital, and she wanted to check her blood to see if she needs to receive the second shot or not, no one gave an answer, she doesn't know what to do, her second shot of vaccination was planned on 06Feb2021. Inhaler that was expired was Albuterol: expiry was Dec2020, lot DAEO68. During a call patient stated that the only symptom that worsened was short of breath. The patient wanted to know whether she could receive her second dose of vaccine. It was also reported that patient was not accepted in urgent care locations because she ""may have covid"" and was instructed to go to the ER (as reported). The patient assessed the events as non-serious. The patient was recovering from the events back pain or the area of the lungs, more like sore on the throat, coughing a few times, throat pain and headache and not recovered from other events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/19/2021,3.0,UNK,,,Medical History/Concurrent Conditions: Asthma,,,"['Asthma', 'Back pain', 'Cough', 'Dyspnoea', 'Fatigue', 'Headache', 'Oropharyngeal pain', 'Pulmonary pain']",1,PFIZER\BIONTECH, 1062019,RI,73.0,F,"Dizzy; This is a spontaneous report from a contactable consumer (patient herself). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: and expiry date were not reported), via an unspecified route of administration in the right arm on 27Jan2021 10:30 at a single dose ""to not get the disease."" Medical history included ongoing mood disorder and ongoing hypertension. Concomitant medication included alprazolam (XANAX) from Apr2020 for hypertension, valproate semisodium (DIVALPROEX) from Dec2020 as mood stabilizer, risperidone from Dec2020 as mood stabilizer and for hypertension, and amlodipine besilate from May2020 for blood pressure. The patient previously took alprazolam (XANAX) for hypertension and had been trying to wean herself because she was getting addicted to it. Alprazolam (XANAX) also made her dizzy and depressed. She also previously took escitalopram (LEXAPRO), fluoxetine (PROZAC), and Zoloft as antidepressants and stated that ""they drove her crazier."" The patient had no additional vaccines administered on same date of the Pfizer Suspect. The patient received that vaccine at housing complex where she resides and was looking at the list that she was given that had reactions. She was feeling dizzy on 27Jan2021 and wanted to know if she should be concerned. The patient reported that she will be speaking with her psychiatrist at 1:30pm during an online appointment asked if she should mention this to her. The event did not require visit to the emergency room or physician office. No relevant tests were conducted. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,XANAX; DIVALPROEX; RISPERIDONE; AMLODIPINE BESILATE,Hypertension; Mood disorder,,,,['Dizziness'],UNK,PFIZER\BIONTECH, 1062020,GA,78.0,F,"Severe headache; Feeling unwell; Joint pains; Muscle pains; Difficulty breathing; Chest pain; Tiredness; She felt a ""little bit of nausea, very slight""; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EL3302), via an unspecified route of administration in the left arm on 23Jan2021 11:00 at single dose for Covid-19 immunisation. Medical history included blood pressure abnormal, thyroid disorder and high cholesterol. Concomitant medications included levothyroxine, lisinopril and rosuvastatin. The patient experienced severe headache, feeling unwell, joint pains, muscle pains, difficulty breathing, chest pain, tiredness on 24Jan2021 and little bit of nausea, very slight on unspecified date in Jan2021. The outcome of headache was recovered on 24Jan2021; for difficulty breathing was recovered; for chest pain and fatigue was recovering; for other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/01/2021,,PVT,LEVOTHYROXINE; LISINOPRIL; ROSUVASTATIN,,Medical History/Concurrent Conditions: Blood pressure abnormal; High cholesterol; Thyroid disorder,,,"['Arthralgia', 'Chest pain', 'Dyspnoea', 'Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Nausea']",1,PFIZER\BIONTECH, 1062021,DC,,M,"go for a walk and had onset of shortness of breath; little soreness in arm; This is a spontaneous report from a contactable consumer (patient himself). An 87-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot/NDC number and expiration date were not provided), via an unspecified route of administration on 26Jan2021 at about 10:30 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he received his first dose of Pfizer COVID-19 vaccine on 26Jan2021 about 10:30 AM at the hospital and he had no effects then. He had a little soreness in arm that night (26Jan2021), but woke up in the morning of the report date, on 27Jan2021 with no soreness in arm, and felt pretty good. Also, at the time of the report on 27Jan2021, he went out to go for a walk and had onset of shortness of breath. He waited a few minutes then continued to walk and still getting the shortness of breath. He called to ask if that was a normal side effect of the vaccine. The patient further indicated having ""no problems,"" went for a walk and experienced shortness of breath. The patient recovered from the event ""little soreness in arm"" on 27Jan2021, while the outcome of the event ""go for a walk and had onset of shortness of breath"" was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PVT,,,,,,"['Dyspnoea exertional', 'Pain in extremity']",1,PFIZER\BIONTECH, 1062022,MD,37.0,F,"tongue and lip tingling; subjective swelling; This is a spontaneous report from a contactable physician reported that a 37-years-old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) intramuscularly on 27Jan2021 at single dose for covid-19 immunisation. Medical history included anaphylaxis; nightshade vegetable allergy; Food allergy, migraine, Attention deficit hyperactivity disorder, anxiety, former smoker. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), alprazolam (XANAX), escitalopram oxalate (LEXAPRO), ethinylestradiol, norethisterone acetate (JUNEL), amitriptyline (AMITRIPTYLINE). The patient previously took atropine had anaphylaxis and known allergies. On 27Jan2021, patient developed tongue and lip tingling and subjective swelling within 10 minutes after vaccine administration. No angioedema. The patient was received treatment with benadryl, pepcid, IVF and solumedrol. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, was the patient was not diagnosed with COVID-19; Since the vaccination, the patient not tested for COVID-19. The outcome of the events was recovered in 2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on vaccine-event chronological association a causal relationship between events ""tongue and lip tingling and subjective swelling"" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,PVT,ADDERALL; XANAX; LEXAPRO; JUNEL; AMITRIPTYLINE,,Medical History/Concurrent Conditions: ADHD; Anaphylaxis; Anxiety; Ex-smoker; Food allergy (anaphylaxis); Migraine,,,"['Paraesthesia oral', 'Swelling']",1,PFIZER\BIONTECH,OT 1062023,CA,,F,"Brain fog and fatigue, increased from first; Brain fog and fatigue, increased from first; Brain fog and fatigue, increased from first; Chills; shortness of breath with exertion; Palpitations; Paresthesias to bilateral hands and right foot/leg; Weakness to bilateral hands; This is a spontaneous report received from a contactable nurse (who is also the patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ELB9B2, expiry date: unknown), intramuscular on the left arm, on 16Jan2021 12:00, at single dose, for COVID-19 immunization, at the hospital. Medical history included myelitis transverse from 2015, and depression. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. There were unspecified concomitant medications. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date: unknown), intramuscular on the left arm, on 26Dec2020 11:30, for COVID-19 immunization and the patient experienced paresthesias to bilateral hands to elbows, right foot/leg with brain fog and fatigue. The patient did not receive other vaccines in four weeks. On 17Jan2021 at 07:00 (also reported as ""12-18 hours after injection""), the patient experienced paresthesias to bilateral hands and right foot/leg; weakness to bilateral hands; brain fog and fatigue, increased from first; chills and shortness of breath with exertion; and palpitations. The events palpitations and shortness of breath with exertion were noticed on day 6 resulting to emergency room visit. It was also reported that the events resulted to emergency room and physician office visits. No treatment was given for the events. The patient was tested for COVID-19 post vaccination via nasal swab with negative result on 22Jan2021. The outcome of the events was recovering (improved gradually).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/17/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Depression; Myelitis transverse,,,"['Chills', 'Condition aggravated', 'Dyspnoea exertional', 'Fatigue', 'Feeling abnormal', 'Muscular weakness', 'Palpitations', 'Paraesthesia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,OT 1062024,MA,40.0,F,"Headache; pain at injection site; This is a spontaneous report from a contactable consumer (Patient). A 40-year-old female non-pregnant patient received first dose of bnt162b2 (formulation: Solution for injection, Brand: Pfizer, Lot number: unknown) via unspecified route of administration at 12:15 on 27Jan2021, on left arm at single dose for COVID-19 immunization. The patient medical history was not reported. The concomitant medication included CELEXA (celecoxib), NEXIUM (esomeprazole sodium) and ZYRTEC (cetirizine hydrochloride). It was reported that on an unknown date in Jan2021 at 07:00, the patient experienced headache and pain at injection site. The events were reported as non-serious by the reporter. The patient had not diagnosed with COVID-19 prior to vaccination and since the vaccination. It was reported that patient had no allergies to medications, food, or other products. The outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/01/2021,,WRK,CELEXA [CELECOXIB]; NEXIUM [ESOMEPRAZOLE SODIUM]; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,,,,"['Headache', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1062025,FL,37.0,F,"Soreness in arm extending beyond injection site; Soreness in arm extending beyond injection site; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). This 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) via an unspecified route of administration on 28Dec2020 (at the age of 37-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hepatitis C. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included buprenorphine, naloxone (SUBOXONE); bupropion (WELLBUTRIN); meloxicam; and lamotrigine (LAMICTAL); all from unknown dates for unspecified indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have allergies to medications, food, or other products. On 28Dec2020 the patient experienced soreness in arm extending beyond the injection site and fatigue for 2 days. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 tests on 28Dec2020, 30Dec2020, 04Jan2021, 08Jan2021, 11Jan2021, 14Jan2021, 19Jan2021, 25Jan2021 with results of negative. The patient did not receive treatment for the events. The events did not cause hospitalization. The outcome of soreness in arm extending beyond injection site was not recovered. The outcome of fatigue was recovered. No follow-up attempts are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,SEN,SUBOXONE; WELLBUTRIN; MELOXICAM; LAMICTAL,,Medical History/Concurrent Conditions: Hepatitis C,,,"['Fatigue', 'Pain in extremity', 'SARS-CoV-2 test', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1062026,NY,,M,"had a little muscle soreness; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on 24Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his vaccine on the 24th, four days ago. He only had a little muscle soreness and took Tylenol. He has another vaccine coming up next week. His next dose isn't until valentine's day. He asked if it was ok to get another vaccine between his doses. The outcome of the event was unknown. No follow-up attempts are possible; information on batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/24/2021,01/01/2021,,UNK,,,,,,['Myalgia'],1,PFIZER\BIONTECH, 1062027,KY,78.0,M,"stated that he developed confusion; experienced awful dreams; concentration to do normal things/it was too difficult to concentrate on the road and talk to her at the same time.; This is a spontaneous report from a contactable consumer (the patient). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249, expiry 31May2021), intramuscular in the left arm, on 27Jan2021 at 09:30 AM (at the age of 78 years) as a single dose for COVID-19 immunization. Medical history was none. Concomitant medication included ergocalciferol (VITAMIN D). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Jan2021 he developed confusion, in which it took a lot of concentration to do normal things and he experienced awful dreams last night. The slight degree of confusion causing him to have to concentrate more than usual for ordinary tasks. The clinical outcome of the events he developed confusion, in which it took a lot of concentration to do normal things and he experienced awful dreams last night was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,PVT,VITAMIN D [ERGOCALCIFEROL],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Abnormal dreams', 'Confusional state', 'Disturbance in attention']",1,PFIZER\BIONTECH,OT 1062028,CT,25.0,F,"Itching skin - Began on arms and legs but has extended to chest, face, scalp, back, etc.; No hives but itching and skin became red; hot in areas; Muscle soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL 3247), via an unspecified route of administration at the left arm on 27Jan2021 10:00 at SINGLE DOSE for covid-19 immunization. The vaccine was administered in a Workplace Clinic. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amoxicillin. The patient experienced Itching skin - began on arms and legs but has extended to chest, face, scalp, back, etc. No hives but itching and skin became red and hot in areas. Itching started around 12 hours post-dose. Muscle soreness at injection site - started approximately 12 hours post-dose. It was reported that event started on 27Jan2021 22:00. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,WRK,AMOXICILLIN,,,,,"['Erythema', 'Feeling hot', 'Pruritus', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1062029,MO,54.0,F,"Soreness in arm, inability to lift above head; Soreness in arm, inability to lift above head; fatigue; minor nausea; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318 and expiration date unknown), via an unspecified route of administration on the right arm on 27Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included COVID-19; prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included Vitamin D NOS and Multi-Vitamin. The patient previously took injectable Iodine and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced soreness in arm - inability to lift above head, fatigue and minor nausea on 27Jan2021 at 13:00 (01:00 PM). No treatment was administered for the events. Since the vaccination, the patient has not been tested for COVID-19. The events were resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,WRK,VITAMIN D NOS,,Medical History/Concurrent Conditions: COVID-19 (if_covid_prior_vaccination: Yes),,,"['Fatigue', 'Joint range of motion decreased', 'Nausea', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 1062030,OH,75.0,F,"On day after had severe muscle ache; severe headache; nauseous; so cold (could not get warm); had a fever; slept for 15 hours; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration on 26Jan2021 17:00 at single dose for covid-19 immunisation. Medical history included mitral valve prolapse and COVID-19. Concomitant medication included bimatoprost (LUMIGAN), colecalciferol (D3), zinc (ZINC), and ubidecarenone (COQ10). The patient experienced severe muscle ache, severe headache, nauseous, so cold (could not get warm), had a fever and slept for 15 hours on 26Jan2021 21:00. The patient received no treatment. The outcome of the events was recovered with sequelae on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,UNK,LUMIGAN; D3; ZINC; COQ10,,Medical History/Concurrent Conditions: COVID-19; Mitral valve prolapse,,,"['Feeling cold', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Somnolence']",1,PFIZER\BIONTECH, 1062031,FL,74.0,F,"Caller says she felt pain in her arm afterwards as well.; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#:not provided), via an unspecified route of administration from on 27Jan2021 (at the age of 74-year-old) at SINGLE DOSE for COVID-19 immunization at the hospital and paracetamol (TYLENOL), via an unspecified route of administration and dates at 2 DF, daily (every morning) for aches and pains. Medical history and concomitant medications were not reported. The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (lot#: not provided) on an unknown date at SINGLE DOSE for COVID-19 immunization and says that she had no reaction to the first shot. The patient received the second dose and had a sore arm (in Jan2021) that was better today. She stated that in the morning she always took two paracetamol for aches and pains; and after she got the first and second shot she read three articles to do not take paracetamol before you get the vaccines as it might affect antibodies. However, no one published about this or said this at the hospital when she went to get the shot, they just asked what she was allergic to it. She would like to know if now she was not so protected because she took paracetamol and if this was a problem. The action taken in response with the adverse event for paracetamol was unknown. Outcome of the event was recovering Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/01/2021,,PVT,TYLENOL ARTHRITIS,,,,,['Pain in extremity'],2,PFIZER\BIONTECH, 1062032,FL,67.0,F,"Loose bowels 2nd day after shot; Rapid heart beat for about an hour second day, but could be thyroid as well; Rapid heart beat for about an hour second day, but could be thyroid as well; Sore arm, not severe; Lethargic for a day; This is a spontaneous report from a contactable other health professional, the patient. This 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 26Jan2021 at 09:00 AM in the left arm (at the age of 67 years-old) for COVID-19 vaccination. Medical history included hypothyroidism, autoimmune disease, allergies to penicillin and many foods. Concomitant medications included etanercept (ENBREL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and losartan potassium (LOSARTIN). The patient receive did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 at 09:00 AM, the patient experienced sore arm, not severe and was lethargic for a day. On 27Jan2021, the patient had loose bowels the second day after the shot and rapid heart beat for about an hour second day, but could be thyroid as well. No treatment was received for events, sore arm, lethargic, loose bowels, rapid heart beat and thyroid. The events were reported as non-serious. The clinical outcome of sore arm, lethargic, loose bowels, rapid heart beat and thyroid was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,PUB,ENBREL; SYNTHROID; CYTOMEL; LOSARTIN,,Medical History/Concurrent Conditions: Autoimmune disorder ( ~~~); Food allergy ( ~~~); Hypothyroidism; Penicillin allergy,,,"['Diarrhoea', 'Heart rate', 'Heart rate increased', 'Lethargy', 'Pain in extremity', 'Thyroid disorder']",1,PFIZER\BIONTECH, 1062033,MD,31.0,F,"headache; night sweats; achy; chills; last menstrual date 19Dec2020 and first administration date=29Dec2020; This is a spontaneous report from a contactable nurse reporting for herself. A 31-year-old pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, via an unspecified route of administration on 29Dec2020 at 13:00 (at the age of 31 years old) as a single dose in the left arm for COVID-19 immunisation. Medical history included seasonal allergies from an unknown date, acid reflux disease from an unknown date, headaches from an unknown date, and irritable bowel syndrome from an unknown date. Concomitant medication included pantoprazole sodium sesquihydrate (PROTONIX), prenatal vitamins, cetirizine hydrochloride (ZYRTEC), and unspecified allergy shot. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache on an unspecified date, night sweats on an unspecified date, achy on an unspecified date, chills on an unspecified date, and last menstrual date 19Dec2020 and first administration date of 29Dec2020. The mother was due to deliver on 25Sep2021. The patient did not receive treatment for the events. The outcome of the events headache, night sweats, achy and chills, and exposure during pregnancy was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/29/2020,12/29/2020,0.0,PVT,PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; ZYRTEC,,Medical History/Concurrent Conditions: Acid reflux (oesophageal) (acid reflux); Headache (headaches); Irritable bowel syndrome (IBS); Seasonal allergy (seasonal allergies),,,"['Chills', 'Exposure during pregnancy', 'Headache', 'Night sweats', 'Pain']",1,PFIZER\BIONTECH, 1062034,MI,,F,"petechiae; This is a spontaneous report from a contactable pharmacist (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the arm on 27Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 28Jan2021, the patient experienced 6 spots of petechiae on the inside of the arm that she received her vaccine. She stated that she got shot on outside of arm. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/28/2021,1.0,UNK,,,,,,['Petechiae'],UNK,PFIZER\BIONTECH, 1062035,NY,71.0,F,"headache; nauseous; soreness at the site; extreme fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN5318, expiration date was unknown), via an unspecified route of administration in the left arm on 24Jan2021 at 12:15 at a single dose for COVID-19 immunization. The vaccine facility type was reported as ""other."" Relevant medical history included hyperactive thyroid; known allergies to penicillin, eggs, and cashews; and severe allergy to all dairy products; all from an unknown date and unknown if ongoing. Concomitant medications included fluvastatin, ezetimibe (ZETIA), acetylsalicylic acid (BABY ASPIRIN), and unspecified multivitamins. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She had not tested for COVID post vaccination. On 24Jan2021, after 2-3 hours of receiving the vaccine, the patient became very nauseous, which lasted for three days. It had eased at the time of the report. On 24Jan2021, the patient also had soreness at the site, extreme fatigue, and headache. The patient had headache for about one day; however, she managed to deal with it without pain killer. The patient drank a lot of warm water with fresh ginger and lemon (with peel) to control the nausea. The patient was very fatigued for three days following the vaccine. Therapeutic measures were taken as a result of nauseous. The patient did not receive treatment for the events ""soreness at the site, extreme fatigue, and headache."" The patient was recovering from the events ""nauseous, soreness at the site, extreme fatigue, and headache.""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/24/2021,0.0,UNK,FLUVASTATIN; ZETIA; BABY ASPIRIN,,Medical History/Concurrent Conditions: Egg allergy; Fruit allergy; Hyperthyroidism; Milk allergy; Penicillin allergy,,,"['Fatigue', 'Headache', 'Nausea', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 1062036,CA,31.0,M,"Sore and stiff arm at injection site only; Sore and stiff arm at injection site only; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: EN 5318, expiration date unknown), via an unspecified route of administration on left arm on 27Jan2021 at 11:45 AM at a single dose for COVID-19 immunization. Medical history included asthma, moderate to marked outdoor allergies. Allergies to medications, food, or other products was none. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), triamcinolone acetonide (NASACORT) and montelukast. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced Sore and stiff arm at injection site only on 26Jan2021 at 17:00. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has not recovered from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,WRK,ALLEGRA; NASACORT; MONTELUKAST,,Medical History/Concurrent Conditions: Allergy (moderate to marked outdoor allergies); Asthma,,,"['Vaccination site pain', 'Vaccination site reaction']",1,PFIZER\BIONTECH, 1062037,NY,29.0,M,"Stomach pain in right quadrant; This is a spontaneous report from a contactable healthcare professional (patient). A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 27Jan2021 17:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced stomach pain in right quadrant on 28Jan2021 with outcome of not recovered. The patient did not receive any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information of Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/28/2021,1.0,PVT,,,,,,['Abdominal pain upper'],UNK,PFIZER\BIONTECH, 1062038,CT,32.0,F,"Pain at injection site; This is a spontaneous report from a contactable consumer (patient herself). A 32-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 26Jan2021 at 11:45 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medications included ibuprofen (ADVIL), paracetamol (TYLENOL), and multivitamins (unspecified); also reported as medications that the patient received within two weeks of vaccination. The patient previously took amoxicillin and Cefzil and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient experienced pain at injection site on 27Jan2021. The patient has not tested positive for COVID-19 since the vaccination. The patient did not receive any treatment for the event. Outcome of the event was recovered. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/27/2021,1.0,WRK,ADVIL [IBUPROFEN]; TYLENOL,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1062039,,52.0,F,"Swelling in the face; This is a spontaneous report from a non-contactable other health professional. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration on 27Jan2021 (at the age of 52years) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling in the face on 28Jan2021. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was recovering. This case is non-serious. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/28/2021,1.0,UNK,,,,,,['Swelling face'],UNK,PFIZER\BIONTECH, 1062040,,62.0,F,"Tingling sensation on her fingertips, on the lower part of her face, and chin; Tingling in her tongue and lip; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 26Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. The patient received the second dose of the COVID-19 vaccine in the morning of 26Jan2021. From that afternoon on (26Jan2021), the patient had tingling in her tongue and lip. The patient did not have this side effect before. The patient was also feeling it on the lower part of her face today (28Jan2021) and is also feeling a tingling sensation on her fingertips. The patient was now (28Jan2021) experiencing a tingling sensation on her tongue, lips, and chin and it doesn't go. The patient wanted to speak with someone to ask if this is a normal side effect or if she should be concerned. The patient was asking what she can do about this. The patient had not recovered from the events. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,UNK,,,,,,"['Paraesthesia', 'Paraesthesia oral']",2,PFIZER\BIONTECH, 1062041,GA,,F,"sore arm; I had an antibody test which was negative; This is a spontaneous report from a contactable physician. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, first dose on 21Dec2020 and second dose on an unspecified date in 2021, both at single dose for COVID-19 immunisation. The patient medical history included chicken pox, she got those in the 1990s, probably in 1994-1995. The patient had unspecified concomitant medications. The patient stated, ""I had an antibody test which was negative"" on 27Jan2021. She says she had no symptoms other than a sore arm on an unspecified date, and then she had her antibodies checked and it is negative. She says she has no known immune deficiencies. The outcome of the events was unknown. Information of lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/21/2020,01/27/2021,37.0,UNK,,,"Medical History/Concurrent Conditions: Chickenpox (she got those in the 1990s, probably in 1994-1995)",,,"['Pain in extremity', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 antibody test negative']",1,PFIZER\BIONTECH, 1062042,MI,77.0,M,"itched everywhere ears, scalp legs and arms.; headache; tired; itchy nose; This is a spontaneous report from a contactable consumer (patient) A male patient of an unspecified age received BNT162B2 (Solution for injection, Lot/Batch number was not reported) via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient received the first vaccine on 21Jan2021. He had a headache, tired and itchy nose. He took a benadryl and it went away. On 25Jan2021 that he itched everywhere ears, scalp legs and arms. The symptoms went away 30 minutes after Benadryl. The patient was not getting any better and maybe a little worse. The outcome of the events was recovered on an unspecified date of 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,UNK,,,,,,"['Fatigue', 'Headache', 'Nasal pruritus', 'Pruritus']",UNK,PFIZER\BIONTECH, 1062043,,,F,"Body aches; 101 degree Fahrenheit fever; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 25Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first single dose of bnt162b2 for Covid-19 immunization. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. On 26Jan2021, patient had body aches, 101 degree fahrenheit fever. Prior to vaccination, patient not diagnosed with COVID-19; Since the vaccination, the patient not tested for COVID-19. There was no treatment received for the adverse events. The outcome of the events was recovered in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/26/2021,1.0,UNK,,,,,,"['Body temperature', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1062044,,,M,"itching sensation in his right hand; allergic reactions from the vaccine; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (reporter's father) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the Pfizer COVID-19 vaccine on Tuesday, 26Jan2021, and later that evening, his father experienced an adverse reaction that was described as an itching sensation in his right hand. The reporter knows that itchiness in the palms and feet are allergic reactions from the vaccine. His father had the injection on right arm. It lasted until 27Jan2021. The reporter asked if there is any reason to be concerned. Outcome of events recovered on 27Jan2021. Events assessed as non-serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,,,,,,"['Allergy to vaccine', 'Pruritus']",UNK,PFIZER\BIONTECH, 1062045,IN,73.0,F,"irregular heart beat; congestion in the chest; dizzy/the dizziness she was having and feeling now after getting the vaccine was definitely more noticeable; This is a spontaneous report from a contactable consumer (the patient). A 73-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left deltoid/ left upper arm in the shoulder on 26Jan2021 around 14:00 (at the age of 73-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: stroke about 4-5 years ago in June, dizziness, blood pressure. The patient also had difficulty writing stuff down; besides having a number issue, she had issues writing numbers down. Concomitant medication included apixaban (ELIQUIS) from an unspecified date and ongoing as a blood thinner. The patient stated she was on ten different medications. These medications were added after the stroke. Before the stroke she was not on any medication. The patient did not have any vaccines administered on same date of the Pfizer COVID vaccine. The patient got the pneumonia vaccine (unspecified), but thinks it was longer than 4 weeks before. She did not remember, but she believed it had been a month and a half to 2 months (at the age of 73-years-old) since getting the pneumonia vaccine for immunization. The patient had the COVID shot on Tuesday of this week (26Jan2021), and she didn't seem to have much of a reaction other than what they expected except at 21:00 that night, she got pretty dizzy. She was still dizzy now. It was enough for her to have to walk with a cane in order to try and keep herself leveled. She could not move quickly. She did not know why she had this reaction. She called her doctor the next day, and he did not understand why. She mentioned she was reading material and saw this could be a severe side effect/situation. The doctor mentioned they were trying to find out if it was related to the blood pressure. She wanted to know if this is part of the side effect, dizziness? When the patient was attempting to provide the zip code, she stated her mind was going blank and could not remember the zip code. She later found something with it written on it and provided those details. She explained she had a stroke when trying to provide her current age. She stated numbers are hard for her. She stated she would be 74 in March, and questioned how old that would make her now, she later confirmed as 73. She read information today about the COVID vaccine, and she saw that one should be cautious about the vaccine if have a bleeding disorder, and she commented she was on a blood thinner. She went to the doctor last week and mentioned she was having dizziness. She clarified she had dizziness before getting the COVID-19 vaccine. When she went to the doctor, they thought it was due to blood pressure as the problem. They changed her blood pressure medication by placing on a higher dose. Then she started having more dizziness, and the dose was taken back down to the dose she was on before. She also added, she has an irregular heartbeat (unspecified date). She went to the doctor because of congestion in the chest (unspecified date); that was why she went to the doctor. The doctor asked about dizziness and she said she was having a little. However, the dizziness she was having and feeling now after getting the vaccine was definitely more noticeable. The clinical outcome of dizzy was recovering (as reported). The outcome of the other events was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,PVT,ELIQUIS,,Medical History/Concurrent Conditions: Acalculia; Blood pressure abnormal; Dizziness; Stroke (She had the stroke about 4-5 years ago in June.); Writing impaired,,,"['Dizziness', 'Heart rate', 'Heart rate irregular', 'Respiratory tract congestion']",1,PFIZER\BIONTECH, 1062046,NJ,62.0,F,"nightmares; difficulty waking up; This is a spontaneous report from a contactable pharmacist (patient). A 62-year-old non-pregnant female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8292), via an unspecified route of administration in the right arm on 27Jan2021 07:15 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) on 09Jan2021 04:45 PM in the left arm for covid-19 immunisation. The patient experienced nightmares and difficulty waking up on 28Jan2021 14:00 with outcome of recovered in 2021. This was very unusual for patient. Events assessed as non-serious. No treatment was received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications that patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/28/2021,1.0,PVT,,,,,,"['Nightmare', 'Somnolence']",2,PFIZER\BIONTECH, 1062047,VA,40.0,F,"taste was altered (sweet foods, not as sweet; savory food, taste bland and bitter); This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264: expiry date: unknown) via an unspecified route of administration in the right arm, on 27Jan2021 at 14:45, at a single dose, for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Concomitant medications included metoprolol and duloxetine hydrochloride (CYMBALTA). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Place where vaccine was administered was reported as ""other"". On 27Jan2021, about 7 hours post injection, the patient's taste was altered (sweet foods, not as sweet; savory food, taste bland and bitter). A full 24 hours after first injection, taste was still altered. The event was considered non-serious. The patient did not receive therapy for the event. Outcome of the event was not recovered. The patient has not been tested for COVID-19 since vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,PUB,METOPROLOL; CYMBALTA,,Medical History/Concurrent Conditions: Blood pressure high,,,['Taste disorder'],1,PFIZER\BIONTECH, 1062048,PA,29.0,F,"Joint/muscle aches; Joint/muscle aches; Mild headache; Sneezing; Sniffling; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3248, expiration date was unknown), via an unspecified route of administration in the left arm on 27Jan2021 at 11:45 at a single dose for COVID-19 immunization. The vaccine facility type was reported as the hospital. The patient had no medical history; she had no known allergies. Concomitant medication included escitalopram. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She was not tested for COVID post vaccination. On 28Jan2021 at 15:00, or around 30 hours post-vaccination, the patient experienced joint/muscle aches, mild headache, sneezing, and sniffling. The patient did not receive any treatment for the adverse events (AEs). The patient was not recovered from all the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/28/2021,1.0,PVT,ESCITALOPRAM,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Headache', 'Myalgia', 'Rhinorrhoea', 'Sneezing']",1,PFIZER\BIONTECH, 1062049,FL,,F,"throat sore; Chills; headaches; fatigue or asthma; fatigue or asthma; cough; tiredness; weakness; This is a spontaneous report from a non-contactable healthcare professional (the patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3246), via an unspecified route of administration in the left arm on 11Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history included asthma. The patient had no known allergies. The patient did not have COVID prior to vaccination. The patient was not pregnant at the time of vaccination. The patient took unspecified concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899), intramuscular in the left arm on 21Dec2020 10:00 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Jan2021, the patient experienced chills, headaches, fatigue or asthma, cough, tiredness, weakness, and throat sore. The patient was treated with antibiotics (unspecified). The clinical outcome of chills, headaches, fatigue or asthma, cough, tiredness, weakness, and throat sore was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Asthma,,,"['Asthenia', 'Asthma', 'Chills', 'Cough', 'Fatigue', 'Headache', 'Oropharyngeal pain']",2,PFIZER\BIONTECH, 1062050,IN,71.0,M,"Uncontrollable itching from the knees down on both legs; This is a spontaneous report from a contactable consumer (patient). A 71-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on the right arm on 25Jan2021 at 13:45 at a single dose for COVID-19 immunization. Medical history included chronic pain, depression and gastroesophageal reflux disease (GERD), and known allergies with Latex. The patient's concomitant medications were not reported; the patient had multiple medications in two weeks. The patient had no other vaccines in four weeks. The patient has no COVID prior vaccination and was not tested for COVID post vaccination. On 25Jan2021 at 16:30, the patient had uncontrollable itching from the knees down on both legs. No treatment was administered for the event. The event had not resolved. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Chronic pain; Depression; GERD; Latex allergy,,,['Pruritus'],1,PFIZER\BIONTECH, 1062051,AR,59.0,F,"nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest of the body; arm swelling and pain; arm swelling and pain / pain was more severe in the arm; This is a spontaneous report from a contactable health professional, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9263,), via an unspecified route of administration on 26Jan2021 12:00 (at the age of 59-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included penicillin allergy, congenital heart defect. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK4176) on 05Jan2021 at 16:00 (at the age of 59-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 27Jan2021 at 00:00 (on the 2nd day), the patient experienced arm swelling and pain. On 28Jan2021 (the 3rd day), the patient was nauseated, and the pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell. The events resulted in a doctor or other healthcare professional visit. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of arm swelling and pain, nauseated, pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell was not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,WRK,METOPROLOL,,Medical History/Concurrent Conditions: Penicillin allergy; Unspecified congenital anomaly of heart,,,"['Heart rate increased', 'Malaise', 'Nausea', 'Pain', 'Pain in extremity', 'Peripheral swelling']",2,PFIZER\BIONTECH, 1062052,NY,65.0,F,"shaking; chills; loss of appetite; fever; joint pain; headache; This is a spontaneous report from a non-contactable consumer. A 65-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not available/provided to reporter at the time of report completion), via an unknown route of administration on 25Jan2021 at 10:00 AM at a single dose at the age of 65 years old for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID). Historical vaccine included at the age of 64 years, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 25Jan2021 at 22:00, after receiving 2nd dose of COVID-19 vaccine in morning, patient experienced chills, shaking, fever, joint pain, loss of appetite, and headache later that evening. She stayed home from work for 2 days and felt better 48 hours later. The reporter assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown since the vaccination, if patient was tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,PVT,SYNTHROID,,,,,"['Arthralgia', 'Chills', 'Decreased appetite', 'Headache', 'Pyrexia', 'Tremor']",2,PFIZER\BIONTECH, 1062053,MD,72.0,M,"minor discomfort at injection site; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318), via an unspecified route of administration on the left arm on 28Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history included hypertension, pre-diabetic, gout, prostate cancer surgery and minor psoriasis. The patient experienced minor discomfort at injection site on 28Jan2021 20:00. The patient received no treatment. The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,OTH,,,Medical History/Concurrent Conditions: Gout; Hypertension; Malignant tumor excision; Pre-diabetic; Psoriasis,,,['Vaccination site discomfort'],1,PFIZER\BIONTECH, 1062054,CA,37.0,F,"she feels body soreness and difficulty moving at a fast pace; she feels body soreness and difficulty moving at a fast pace; It just that my muscles are too weak. It was 'like it is after half a mile of swimming'; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9262, expiry date was unknown) via an unspecified route of administration, on 26Jan2021, at single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. Patient reported that she received first dose of vaccine Tuesday. She did not feel sick or as if she has the flu per her report. She felt body soreness and difficulty moving at a fast pace in Jan2021. She would like to know if it will be okay for her to get the second dose of vaccine. Patient stated that my muscles are too weak in Jan2021. Patient also reported that, I have no fever, I have no cough, I don't feel sick. It just that my muscles are too weak. It was 'like it is after half a mile of swimming' (not clear over the call). I was reading all the papers and it says that it is normal as of one of the symptoms. I was just wondering how long it will take to be that away."" No treatment was given to the events. Outcome of the events was reported as unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/01/2021,,UNK,,,,,,"['Hypokinesia', 'Muscular weakness', 'Pain']",1,PFIZER\BIONTECH, 1062055,TX,49.0,F,"2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil eraser; it feels warm at the injection site; arm was initially sore and that was all/a sharp pain in her arm/it was very sore/arm hurt; I didn't realize if a 'lesion' (not clear over the call) kind of formed overnight; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiry Date: Unknown), via an unspecified route of administration in left arm on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. It was reported that patient had her 1st Pfizer vaccine dose on Monday, 25Jan2021, her arm was initially sore and that was all. Then sometime today (on 28Jan2021) she has developed 2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil eraser. She was driving home from work and felt a sharp pain in her arm. She pulled her car over because it was ""very sore"". ""she was glad that she was close to home when this happened. It was kind of freaked her out."" Patient also stated that she got the vaccine on Monday and today (on 28Jan2021) she was driving home. She hadn't had any issues other than her arm hurt but it feels warm at the injection site and she just got in to her house, she wanted to stretch, she didn't realize if a 'lesion' (not clear over the call) kind of formed overnight in Jan2021, it hurts, her arm hurts."" No lab work was done. No treatment was received for the events. The outcome of the events was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Pain in extremity', 'Skin lesion', 'Vaccination site vesicles', 'Vaccination site warmth']",1,PFIZER\BIONTECH, 1062056,TN,37.0,F,"2nd dose: Fever; extreme chills; all over muscle aches; loss of taste; extreme fatigue; upset stomach; dehydrated; weakness; loss of appetite; chest tightness; feel like a panic attack; This is a spontaneous report from a contactable Other Healthcare Professional, the patient. A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), intramuscularly on 19Jan2021 at 11:00 (at the age of 37-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history was not provided. The patient has no allergies to medications, food, or other products. Historical vaccinations include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686) on 30Dec2020 at 19:00 intramuscularly as a single dose in the right arm for COVID-19 vaccination after which the patient experienced fatigue, muscle soreness in neck and shoulders and vaccination site pain. The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MIDOL) and ibuprofen(MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 19Jan2021 at 23:30 she began to experience fever, extreme chills, all over muscle aches, loss of taste for a day ,extreme fatigue, upset stomach, dehydrated, weakness, loss of appetite, chest tightness that would come and go making it feel almost feel like a panic attack. She further stated that she has lingering side effects such as extreme fatigue, muscle aches and chest tightness after day three of receiving this second dose that comes and goes. Currently on day seven and still have those lingering three side effects. Fatigue has been extreme at times. The patient did not receive any treatment for the events. The clinical outcomes of the events Fever, extreme chills, myalgia, loss of taste, extreme fatigue, upset stomach, dehydration, weakness, loss of appetite, chest tightness and panic attack were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107223 Same reporter, Same product, Same patient, same and different events (First Dose)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,PVT,MIDOL; IBUPROFEN,,,,,"['Abdominal discomfort', 'Ageusia', 'Asthenia', 'Chest discomfort', 'Chills', 'Decreased appetite', 'Dehydration', 'Fatigue', 'Myalgia', 'Panic attack', 'Pyrexia']",2,PFIZER\BIONTECH,OT 1062057,MO,70.0,M,"Itching rash with raised bump on back; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3302), via an unspecified route of administration on 28Jan2021 12:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included hypertension, seasonal allergies, arthritis, allergic to avocado, cantaloupe, water mellon. Concomitant medication included lisinopril, atorvastatin, allopurinol, loratadine. The patient experienced itching rash with raised bump on back on 28Jan2021 16:00 with outcome of not recovered. Patient didn't receive treatment for the adverse event.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,UNK,Lisinopril; Atorvastatin; Allopurinol; Loratadine,,Medical History/Concurrent Conditions: Arthritis; Fruit allergy; Hypertension; Seasonal allergy,,,['Rash pruritic'],1,PFIZER\BIONTECH, 1062058,CA,66.0,F,"Slight dizziness; body ache; Tiredness; This is a spontaneous report from a contactable nurse (patient). A 66-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), intramuscularly on the left arm on 27Jan2021 at 10:00 at a single dose for COVID-19 immunization. Medical history included diabetes borderline. The patient has no allergies to medications, food, or other products. Concomitant medications included metformin (METFORMIN), and lorazepam (LORAZEPAM). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced slight dizziness, body ache and tiredness on 27Jan2021. No treatment was administered for the events. Since the vaccination, the patient has not been tested for COVID-19. No treatment was administered for the events. The events resolved on an unknown date. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,PVT,METFORMIN; LORAZEPAM,,Medical History/Concurrent Conditions: Borderline diabetes,,,"['Dizziness', 'Fatigue', 'Pain']",2,PFIZER\BIONTECH,OT 1062059,,,F,"Fever; headache; nausea; aches and pain; joint pain; she feels like she has the worst flu ever; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A female patient of an unspecified age (age: 62 (unspecified unit)) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), at single dose for COVID-19 immunisation and did not feel any symptoms with her first dose. Caller reported that she received second dose yesterday (27Jan2021). Caller was experiencing the following symptoms today (28Jan2021): Fever, headache, nausea, aches and pain, joint pain. Caller states that she feels every single side effect she has. Caller reports that she feels like she has the worst flu ever. Caller states that she has taken Tylenol. Caller would like to know how long her symptoms will last. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/28/2021,1.0,UNK,,,,,,"['Arthralgia', 'Headache', 'Influenza', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1062060,,,U,"Major skin reaction; This is a spontaneous report from a non-contactable physician received via a sales representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced major skin reaction on an unspecified date with outcome of unknown. Event took place after use of product. No follow-up attempts are possible. Information about lot/Batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Skin reaction'],UNK,PFIZER\BIONTECH, 1062061,NY,76.0,F,"Tinnitus spiked up quite a bit /tinnitus was reported as worsened /her tinnitus increased a great deal. It increased in loudness; arm was sore; stomach ache; upsetting and distressing; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration at 13:30, on right arm, on 25Jan2021, at single dose for COVID-19 immunisation. The patient relevant medical history included heart condition, she is mostly allergic to antibiotics (She has allergies to several medications; Specific antibiotic names not provided), blood pressure, anxiety, thyroid (thyroid disorder), urinary tract health, I have had tinnitus for 7 years and Bones (bone disorder) and of them were ongoing. The patient concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder and ongoing at 50ug, daily, hydrochlorothiazide tablet for blood pressure and ongoing at 0.25mg (half tablet) once a day, valsartan(DIOVAN) for blood pressure ongoing at 80mg once a day, verapamil for heart issue ongoing at 100mg, metoprolol tartrate for heart, ongoing at 25mg twice a day, alprazolam (XANAX) for anxiety ongoing at 0.25mg, once a day, d-mannose for urinary tract health ongoing at 300mg once a day, vitamin d nos for bones ongoing at 50ug daily, calcium carbonate (CALTRATE) for bones at unknown dose once day, ubidecarenone (COQ10) for heart ongoing at 200mg, magnesium for the heart. It was reported that patient got tinnitus after taking an antibiotic and had for 7 years. After taking the first dose on Monday (25Jan2021), the tinnitus spiked up quite a bit on 27Jan2021 (noticed when she woke up at about 08:00 in the morning). Tinnitus got very much louder, and patient thought that it was from vaccine. Tinnitus increased a great deal. It increased in loudness and was reported as worsened. On an unknown date in Jan2021, the patient arm was sore and got better. The patient also had little bit of a stomach-ache at first and that got better as well on an unknown date in Jan2021. The patient thought that the tinnitus would return to my normal level of loud. The patient reported that it's very upsetting and distressing on an unknown date in Jan2021. The patient was worried about getting the second shot. The patient also stated that had allergic reactions to many drugs and did fine with the vaccine in terms of anaphylaxis. It was reported that prior vaccinations within 4 weeks was none. It was reported that patient had not administered additional vaccines on same date of pfizer suspect administration. The outcome of the events tinnitus spiked up quite a bit /tinnitus was reported as not recovered /her tinnitus increased a great deal. It increased in loudness was not recovered, upsetting and distressing was unknown, stomach-ache and arm was sore was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/01/2021,,UNK,SYNTHROID; HYDROCHLOROTHIAZIDE; DIOVAN; VERAPAMIL; METOPROLOL TARTRATE; XANAX; D-MANNOSE; VITAMIN D NOS; CALTRATE [CALCIUM CARBONATE]; COQ10 [UBIDECARENONE]; MAGNESIUM,Allergy to antibiotic; Anxiety; Blood pressure abnormal; Bone disorder; Heart disorder; Thyroid disorder; Tinnitus; Urinary tract disorder,,,,"['Abdominal pain upper', 'Depression', 'Pain in extremity', 'Tinnitus']",1,PFIZER\BIONTECH, 1062062,,,F,"Flank and spinal pain; Flank and spinal pain; Sore at the shot location site; She experienced 24 hours of flu like symptoms; This is a spontaneous report from a non-contactable other healthcare professional. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID vaccine 3 weeks ago. On an unspecified date, the patient had flank and spinal pain that lasted two days after the first dose. She also was sore at the shot location site. After vaccination, she also experienced 24 hours of flu like symptoms and spent a day laying on her couch. Outcome of the events was unknown. No follow-up attempts are possible. Information about batch/lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Flank pain', 'Influenza like illness', 'Spinal pain', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1062063,CA,34.0,M,"Slight pain in deltoid muscle when lifting left arm.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot number: EN 5318, expiration date unknown), via an unspecified route of administration on the left arm at the age of 34 years old on 28Jan2021 at 10:45 at a single dose for COVID-19 immunisation in the workplace clinic. Patient has no medical history reported. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced slight pain in deltoid muscle when lifting left arm on 28Jan2021. No treatment was received in response to the event. The patient assessed the event was non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Myalgia'],UNK,PFIZER\BIONTECH, 1062064,AZ,,U,"Orthostatic hypotension; neurological sequalae; foggy brain; This is a spontaneous report from contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender (age within 30-49 years old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced orthostatic hypotension, neurological sequalae, and foggy brain on unspecified date which were post 10-day administration. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Feeling abnormal', 'Nervous system disorder', 'Orthostatic hypotension']",UNK,PFIZER\BIONTECH, 1062065,,,U,"Severe rash/The rash occurred on 90% of the patient's body.; This is a spontaneous report from a contactable physician via a Pfizer Sales Representative. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that a patient was treated (treatment not reported) because of severe rash which occurred in a patient within 24 hours of receipt of the vaccine. The rash occurred on 90% of the patient's body. The outcome of the event was unknown. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Rash'],1,PFIZER\BIONTECH, 1062066,CT,23.0,F,"Sore arm; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 27Jan2021 at 14:30 at a single dose on right arm for COVID-19 immunisation. Medical history included polycystic ovaries (Polycystic Ovarian Syndrome) from an unknown date and unknown if ongoing. Concomitant medications included metformin, spironolactone, buspirone and ethinylestradiol, levonorgestrel (CAMRESE). The patient experienced sore arm and tiredness on 27Jan2021 at 15:00. Treatment received for the adverse event was reported as No. Outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,WRK,METFORMIN; SPIRONOLACTONE; BUSPIRONE; CAMRESE,,Medical History/Concurrent Conditions: Polycystic ovarian syndrome,,,"['Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH, 1062067,,27.0,F,"Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; This is a spontaneous report received from a contactable consumer (patient). A 27-year-old female patient (not pregnant) received first dose of BNT162B2 (COVID 19, Pfizer, Solution for injection, Lot number: EL3247), intramuscular on left arm on 27Jan2021, 10:00 AM at single dose for COVID-19 immunization. Relevant medical history included minor allergies to avocados, almonds, and kiwis. Concomitant medications in two weeks included birth control and Vitamin D NOS (vitamin D supplement). No other vaccine was received by the patient within four weeks. On 27Jan2021 at 11:30 AM, the patient experienced sore arm where injected within an hour or so, became more sore over the next day (28Jan2021) followed by chills, body aches, headache and slight fever starting the morning after vaccination on 28Jan2021. No treatment was received by the patient. The patient was not tested COVID prior and post vaccination. On 03Feb2021, the patient stated that on 27Jan2021, the patient received the vaccination and first had the soreness. The patient reported on 29Jan2021 when patient had recovered from symptoms. The outcome of the events was recovered on 29Jan2021. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,WRK,VITAMIN D NOS,,Medical History/Concurrent Conditions: Fruit allergy,,,"['Chills', 'Headache', 'Pain', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 1062068,NC,71.0,M,"stabbing pain in base joint of left thumb; Right knee has osteoarthritis; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 15:00 (Lot number: E29262) via an unspecified route of administration in the right arm at single dose for COVID-19 immunization. The patient's medical history includes Left thumb normally has some arthritis pain and 3-weeks since repair of bleeding ulcer unknown if ongoing from an unknown date. The patient had no had no allergies to medications, food, or other products. The patients concomitant medications included sucralfate, pantoprazole, ferrous sulfate and bifidobacterium nos, lactobacillus acidophilus, lactobacillus paracasei, streptococcus thermophilus (RISAQUAD). The patient did not receive any other vaccine within four weeks. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. The patients left thumb normally has some arthritis pain, but within 2-hours of vaccination, experienced stabbing pain in base joint of left thumb, when grasping objects. Lasted intermittently for 6-hours, then subsided. Right knee has osteoarthritis, with some pain when walking, but was not affected. The events were assessed as non-serious by the reporter. The patient did not received treatment for the event. The outcome of the event was recovered on 28Jan2021 23:00. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,SUCRALFATE; PANTOPRAZOLE; FERROUS SULFATE; RISAQUAD,,Medical History/Concurrent Conditions: Arthritic pains; Ulcer management,,,"['Arthralgia', 'Osteoarthritis']",UNK,PFIZER\BIONTECH, 1062069,OH,53.0,F,"abnormal sleep patterns; sleep problems/Sleep is worse after the covid vaccine; sleep problems/Sleep is worse after the covid vaccine; This is a spontaneous report from a contactable healthcare professionals. A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on the left arm on 23Jan2021 12:45 at single dose for COVID-19 immunization. Medical history included depression anxiety and ongoing sleep problems. There were no concomitant medications. It was reported that the patient got the first dose and had abnormal sleep patterns on an unspecified date. It was reported that the patient was concerned that the Pfizer vaccine may contain something that could damage her brain and make it so she can't sleep. She stated she has existing issues with sleep so she is unsure if the vaccine has affected her sleep or not. She just wants to know if there is something in it that could affect her sleep. Added that she was able to fall asleep that night and then woke up in the middle of the night but that is not unusual. Added she has problems with sleep anyway and she is wondering if there is anything in the vaccine that could interfere with her sleep or could cause you to not be able to sleep. It was reported that the patient's sleep is worse after the COVID vaccine. She wanted to know if it is because of the vaccine. She is scheduled for the next dose on 13Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,,,UNK,,Sleep disorder,Medical History/Concurrent Conditions: Anxiety depression,,,"['Condition aggravated', 'Irregular sleep wake rhythm disorder', 'Sleep disorder']",1,PFIZER\BIONTECH, 1062070,IL,,M,"the caller experience some headaches; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. This consumer reported similar events for two patients. This is 1st of two reports. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunization. The patient's medical history were not reported. Concomitant medications included paracetamol (TYLENOL) for arthritis. The patient received 1st shot of the covid19 vaccine last Saturday. He asked if it is fine to take Tylenol after the shot because the patient and his wife experience some headaches in Jan2021. He explained that he takes Tylenol for his arthritis in accordance to his doctor's instructions. He was never told to discontinue the Tylenol before taking the COVID-19 vaccine. After the shot, he continued taking the Tylenol as well because he had some headaches from what he believes were the side effects of the vaccine. He was told by some people that it was not good to take Tylenol after the COVID-19 vaccine, that it impacts the efficacy of the vaccine and asked if this was true and if he should stop taking the Tylenol. Therapeutic measures were taken as a result of headache. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092405 same reporter/drug/AE, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,01/01/2021,,UNK,TYLENOL,,,,,['Headache'],1,PFIZER\BIONTECH, 1062071,IL,,F,"headache; This is a spontaneous report from a contactable consumer (patient's husband) via a Pfizer-sponsored program . This consumer reported the same events for two patients. This is the second of two reports. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took 6-8 pills of TYLENOL after receiving the vaccine because she was having a headache on Jan2021. Outcome of the event was unknown. Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092403 same reporter/drug/AE, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,01/01/2021,,UNK,,,,,,['Headache'],1,PFIZER\BIONTECH, 1062072,,,M,"I get cluster headaches; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient himself) reported that a male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, lot/batch number were not reported), via an unspecified route of administration from an unspecified date at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced cluster headaches on an unspecified date and was taking a medicine (Triptans). The outcome of event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Cluster headache'],1,PFIZER\BIONTECH, 1062073,LA,,F,"Got an ear infection last week; This is a spontaneous report from a Pfizer sponsored program, . A contactable consumer (patient) reported a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: unknown), via an unspecified route of administration and date at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first shot already on an unknown date. She got an ear infection last week (in 2021) and was inquiring if she can get a second shot while taking antibiotics for ear infection. Outcome of the event was not recovered. Information on the LOT/Batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Ear infection'],1,PFIZER\BIONTECH, 1062074,FL,,M,little drowsy; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 via an unspecified route of administration on an unspecified date at a single dose as Covid-19 vaccine. Medical history and concomitant medications were not reported. The patient slept really good. It was reported that he got a little drowsy after being vaccinated on an unspecified date. The outcome of the event was unknown. Information on the lot/ batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Somnolence'],UNK,PFIZER\BIONTECH, 1062075,NJ,89.0,F,"This is a spontaneous report from a contactable consumer (patient). An 89-years-old female patient received first single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (by injection once to left arm) on 22Jan2021 COVID-19 immunization since patient was in an independent facility with 238 residents. The patient had no relevant medical history. There were no concomitant medications. She said she got her first COVID-19 Vaccine dose on a Friday. She said she had no pain in her arm after receiving the first COVID-19 Vaccine, but then on 26Jan2021 she noticed about 8 hives right at her waist line. She asked if the hives were a reaction to the COVID-19 Vaccine. She said her skin was red and puffy in 8 different places on her waistline. She said her skin on her waistline looks like what happens when being allergic to something. She said she lives in an independent living community, and the COVID-19 Vaccine was provided to the residents in a group setting. She said no COVID-19 Vaccine immunization cards were provided at the time of vaccination. Patient reported ""you know when the person gets hives, you get blisters, red blisters and now they are getting worse"" and asked if that was a side effect from the vaccine."" She was fine for a couple days, then noticed, and she doesn't know if this is a side effect or not, the waistline, she has about 5, states ""you know when a person gets hives in the skin, it is raised and red? Is that a side effect?"" States she shrunk (onset date not reported). There was a doctor there she would see her week and would show her, she will be giving her a physical. Patient would try to get physical therapy there. She further stated it looks like hives, she was looking now, she has 8 hives, they were the same color, and it was also itchy. She was not given a vaccine card. She was brought into a dining room, one area aside, there was a nurse, and applications already filled out, she has no idea what her number was, but after the injection she was put in another room, and sat for 15 minutes, to make sure no reaction, and there wasn't, she had no pain in arm, she felt well, but this showed up. She has to go back in 3 weeks for second injection. No investigation assessment was performed. The outcome of shrunk was unknown and not recovered (ongoing) for the other events. Information about Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/26/2021,4.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Blister', 'Body height decreased', 'Hypersensitivity', 'Rash maculo-papular', 'Skin swelling', 'Urticaria']",1,PFIZER\BIONTECH, 1062076,NJ,66.0,M,"always feels achy; hyperthermia (high temperature: 101.2 degrees Fahrenheit); headaches; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), via an unspecified route of administration on 25Jan2021 at a single dose on the left arm to not get Covid. The patient's medical history included joint disorder (reported as: for his hip). Concomitant medication included ongoing paracetamol (TYLENOL, lot number: SMA051, expiry date: Aug2024) for his hip. Patient reported that his son tested positive of Covid-19. On 25Jan2021, patient received the first dose of vaccine and experienced hyperthermia (high temperature: 101.2 degrees Fahrenheit) and headaches on 27Jan2021. Patient also stated that he always feels achy on an unspecified date. Patient wanted to know if being around his son who has tested positive would have an effect to his vaccine. The patient underwent lab tests and procedures which included body temperature: 101.2 degrees Fahrenheit on 27Jan2021 down to 99.8 degrees Fahrenheit on an unspecified date. The outcome of the event hyperthermia (high temperature: 101.2 degrees Fahrenheit) was recovering; headaches was not recovered while the other event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/27/2021,2.0,PVT,TYLENOL,,Medical History/Concurrent Conditions: Joint disorder,,,"['Body temperature', 'Headache', 'Hyperthermia', 'Pain']",1,PFIZER\BIONTECH, 1062077,,,F,"sinus headache; pollen allergy; This is a spontaneous report from a Pfizer-sponsored Program. A non-contactable consumer (reporting for herself) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, first dose on an unspecified date at single dose, for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date after getting first dose on a morning, patient experienced pollen allergy and a sinus headache and was asking if it was okay to take ADVIL and Ibuprofen. The outcome of the events was recovered. No follow up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Seasonal allergy', 'Sinus headache']",1,PFIZER\BIONTECH, 1062078,GA,,F,"she has been seeing some blood when she blows her nose; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient verbally reported that she has been seeing some blood when she blows her nose. Outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Epistaxis'],UNK,PFIZER\BIONTECH, 1062079,OK,,F,"not feeling okay; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking how to register/sign up with V-safe. She doesn't know how to use a smartphone. At the end of the call, while transferring to the Consumer Fact sheet, the patient said she is not feeling okay then call got disconnected. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,,,UNK,,,,,,['Malaise'],UNK,PFIZER\BIONTECH, 1062080,TX,73.0,F,"she's not feeling well; This is a spontaneous report from a contactable consumer (patient's daughter-in-law) via the Pfizer-sponsored program. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 26Jan2021, at single dose, for covid-19 immunization. Medical history included covid-19 - the patient has been tested positive on an unspecified date but it's 2 months now, and they said that it's still in her. Concomitant medications were not reported. The patient had the first shot yesterday 26Jan2021 and she's not feeling well on Jan2021. The outcome of the event was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/01/2021,,UNK,,,"Medical History/Concurrent Conditions: COVID-19 (the patient has been tested positive on an unspecified date but it's 2 months now, and they said that it's still in her)",,,"['Malaise', 'SARS-CoV-2 antibody test']",1,PFIZER\BIONTECH, 1062081,KY,,M,"Mild soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient did not have any reaction except for a very mild soreness at the injection site on an unspecified date. The patient wanted to known if is there any correlation to the minimal reaction and effectiveness. Does that have any correlation to the effectiveness of the vaccine for him. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021111577 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1062082,,,U,"Body aches; Low grade fever; Chills; Swollen upper lip; This is a spontaneous report from a non-contactable Physician via the Pfizer-sponsored program. A patient of unspecified age and gender receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number ), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The physician reported that 13 hour after vaccination, the patient developed body aches, low grade fever, chills, and swollen upper lip, on an unspecified date. The patient took Tylenol for the body aches, low grade fever, chills, and swollen upper lip. The clinical outcome of body aches, low grade fever, chills, was recovered. The outcome of and swollen upper lip was not revered. No follow-up attempts are possible; information about lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Chills', 'Lip swelling', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1062083,MS,63.0,F,"heart start palpitating and racing; kind of warm; This is a spontaneous report from a contactable consumer (patient) reported that a 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 26Jan2021 11:00 at a single dose for Covid-19 immunization, and potassium chloride ER, via an unspecified route of administration from an unspecified date at 10 mg, daily (every day) for low potassium. Medical history included anxiety and was afraid to take her anxiety medicine; hypertension, and iron deficiency; all from an unknown date. Concomitant medications included amlodipine besilate (NORVASC) for hypertension, and colecalciferol (VITAMIN D [COLECALCIFEROL]). It was reported that when the patient got the shot it did not hurt but when she sat down for about a minute (26Jan2021), her heart start palpitating, and racing and then she got kind of warm and then it went away. She didn't pass out, had no shortness of breath. She just wanted to know if it was one of the side effects and that's why she need to report this. The patient was looking at the ingredients that Pfizer have like potassium and stuff. The patient takes potassium every day. She added that maybe she should have not taken her potassium at the same day, would make your heart raise that's why she was wondering. Otherwise the patient felt fine. She just needed to report this. Furthermore, patient stated that maybe because she was nervous, she was scared to take certain anxiety medicines (unspecified medications) she did not know would had it though. The outcome of the events was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,NORVASC; VITAMIN D [COLECALCIFEROL],,"Medical History/Concurrent Conditions: Anxiety (she has anxiety, and was afraid to take her anxiety medicine); Hypertension; Iron deficiency",,,"['Feeling hot', 'Palpitations']",UNK,UNKNOWN MANUFACTURER, 1062084,NJ,51.0,F,"blood sugars have been out of control in the range of 400-500's; This is a spontaneous report from a contactable nurse reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EH9899/expiration date: not provided), via an unspecified route of administration, on 31Dec2020 at 04:15 PM (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included insulin-dependent diabetes mellitus (IDDM) ongoing since an unknown date and thyroid cancer excised on an unknown date. The patient had a penicillin allergy and Nubain allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included insulin lispro (HUMALOG), insulin glargine (LANTUS) and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Jan2021, the patient experienced blood sugars have been out of control in the range of 400-500's. The event blood sugars have been out of control in the range of 400-500's did not result in hospitalization. The patient received treatment for the event blood sugars have been out of control in the range of 400-500's included increasing the amount of insulin. The patient reported that after receiving the vaccination, her blood sugars have been out of control in the range of 400-500's. She was doubling the amount of insulin with little ability to get her sugars within normal range. It took a week to 10 days for her insulin requirement to come close to baseline after the first vaccine dose. The outcome of the event blood sugars have been out of control in the range of 400-500's was unknown. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on a compatible temporal association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to event ""blood sugars have been out of control in the range of 400-500's"" in this insulin-dependent diabetes mellitus patient cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/01/2021,1.0,PVT,HUMALOG; LANTUS; MULTIVITAMINS [VITAMINS NOS],IDDM,Medical History/Concurrent Conditions: Penicillin allergy; Thyroid cancer (thyroid cancer excised),,,"['Blood glucose', 'Diabetes mellitus inadequate control']",1,PFIZER\BIONTECH, 1062085,NJ,78.0,F,"medical history of arthritis treated with cortisone; medical history of arthritis treated with cortisone; Rash on her face/rash on the cheek; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included ongoing arthritis in her knee (for 7-8 years) and blood pressure high but so far so good. Concomitant medication included cortisone for arthritis in her knee. The patient previously had cortisone shot for arthritis and experienced rash on her face. On 14Jan2021, patient got the first vaccine dose and had rash on her face/rash on the cheek. Her next one is due 04Feb2021. The outcome of the events was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/14/2021,0.0,UNK,CORTISONE,Knee arthritis,Medical History/Concurrent Conditions: Blood pressure high,,,"['Off label use', 'Product use issue', 'Rash']",1,PFIZER\BIONTECH, 1062086,IN,69.0,F,"muscle spasms; wasn't feeling well; she stumbled again, and fell against her car; too tired; cry; patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine; patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine; headaches/The headache is above her ear and the pain is ""past 10""; She recalled experiencing ""swelling around her eyes"" and ""had some swelling"" after the 1st dose of the Pfizer-Biontech COVID19 vaccine/left eye swelling; had some swelling; Dizziness/Lightheadedness; Vomiting; Blurry vision; She said the left arm pain started immediately after receiving the COVID-19; Injection site swelling; she is sweating something fierce under her arms; peeing on herself (running to bathroom more); lady asked her to call her when she got home, and she forgot, saying her mind wasn't there; acid reflux taste in mouth/she tasted the COVID-19 Vaccine shot when it was administered; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982; expiration date: unknown) at the age vaccination of 69-year-old via an unspecified route of administration in the upper left arm on 19Jan2021 08:00 (also reported as 11Dec2020) at a single dose for covid-19 immunization. Medical history included was hit by a truck a GM and the truck busted her legs up, ongoing RSD (Reflex Sympathetic Dystrophy) pain since 1991 and was prescribed with oxycodone/acetaminophen (PERCOCET), rheumatoid arthritis from 1991 to an unknown date, spinal cord implant is in her spine, and goes from her spine to her waist, and from her waist to both legs, and down to her ankles from 1991 to an unknown date and migraine when she was 12 or 13 years old. There were no concomitant medications. She received the vaccine in a hospital. The patient previously had a flu shot for immunization but was allergic to the flu shot. It was reported that a patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine on 19Jan2021 08:00. On 19Jan2021, the patient reported that she said she had a slight headache, left eye swelling, dizziness, vomiting, blurry eyes, sweating up under her arms, and peeing on herself (running to bathroom more) after receiving the COVID-19 Vaccine. It was reported that the patient had injection site swelling on 19Jan2021. She said she has never had any side effects like what she is experiencing now after getting the COVID-19 Vaccine. She reported that her mild headache turned severe over the weekend, and she had to wrap a towel around the back of her head, so she could lay down. She said the headache pain was a sharp pain at the bottom of the back of her head and neck. She clarified she had migraines when she was 12 or 13 years old, but the headache pain she had now is nothing like the migraines she had then. She further clarified that her severe headache feels like a knife in the back of her head and neck. She said the pain is more severe on the right side of her head than the left. She said right now she has pressure in the front of her head with a slight headache. She additionally clarified that the swelling in her left eye comes and goes and is persisting. She said her left eye didn't swell close, but her granddaughter told her it looks like something is wrong with her left eye. She added that she had dizziness this morning when she was going to work. She said she stumbled when she was walking this morning but drove to work anyway. She said when she got to work, she wasn't feeling well on an unspecified date, so she decided to go back home. She said when she was walking to her car, she stumbled again, and fell against her car. She reported when she first got the COVID-19 Vaccine (19Jan2021), she was driving in a bad way. She said after she got her COVID-19 Vaccine, she picked up an elderly lady she sits with, and the elderly lady told her she wasn't normal. She said the elderly lady told her she was too relaxed while she was driving, like she was in a daze. She said the elderly lady said she was scared for her and herself when she was driving. She said the elderly lady asked her to call her when she got home, and she forgot, saying her mind wasn't there. She mentioned that she had to wait 15 minutes after receiving her COVID-19 Vaccine (19Jan2021), and when she was driving home, she had to pull over and get out of her car to vomit. She said she had an acid reflux taste in mouth before she threw up. She said she threw up a little bit last night when she had a severe headache. Clarified her eyes are constantly blurry now. She said she has to put her glasses on to see but has to turn her head sideways in order to see anything past her blurriness. She said her burry eyes are worse at night. She stated that she was sweating something fierce under her arms, she said she has to take 3 showers a day now to get rid of the sweating and smell under her arms. She said she has never sweated like that before. She reported her left arm is sore too. She said the left arm pain started immediately after receiving the COVID-19 Vaccine (19Jan2021). She said she has swelling too, and has been rubbing her left arm with alcohol, but the left arm soreness is still there. She reported that she tasted the COVID-19 Vaccine shot when it was administered. She has blown off calling her doctor when she first experienced her side effects, but then her headache got worse. She said she so spoke to doctor 30 minutes before calling Pfizer. She said she told her doctor if her headache comes back, she is going to the emergency room when she gets off work after tonight. She stated that she has been experiencing headaches/muscle spasms that have been getting worse. She says they last 15-20 minutes and then it stops. The headache is above her ear and the pain is ""past 10"". Yesterday night (unspecified date), the headache was so severe that she wanted to go to the ER but was too tired. The patient reported that she was taking ibuprofen (ADVIL) for her slight headache. She said she took the Advil for a couple days and nights, and her headache eased up some with the Advil. She reported that 2 days ago she bought aspirin, caffeine, acetaminophen (EXCEDRIN MIGRAINE). She also reported that she started taking Ibuprofen when her headaches became severe. She said the Ibuprofen eased the headache, but the headache comes back. Reported she took pain medicine prescribed from a doctor way back, and the prescription pain medication doesn't ease her headache pain. She clarified that the medication was dispensed in a pharmacy was oxycodone, acetaminophen (PERCOCET). She called her doctor when she returned home from work this morning, and her doctor told her to call Pfizer to report her side effects. She reported when she went to work this morning, she got lightheaded. She took Percocet and other medications, but it hasn't relieved it. She says it's not a migraine. She recalled experiencing ""swelling around her eyes"" and ""had some swelling"" after the first dose of the Pfizer-Biontech COVID19 vaccine on 19Jan2021. She reported on 02Feb2021 that she was calling back today to report that her headaches were worse. She said her headaches are not a migraine, but more like a muscle spasm in the right side of her head, above her ear. She said the pain is between her neck and ear on the right side of her head. She said the headache pain feels like it is as big as a golf ball. She said her headache pain is so severe, the headache pain wakes her up in a cry. She said the headache pain lasts 15-20 minutes, and then eases up slightly. She said the headaches have been happening twice at night, and twice during the daytime. She said the headache pain doesn't last long. She mentioned that she has been doing self-remedies. She said she ate a spoonful of mustard to ease the headache, and the spoonful of mustard did ease her headache. The patient inquired if she should get the second COVID-19 Vaccine if she is continuing to experience headaches after receiving the first COVID-19 Vaccine. The outcome of the events headache, eye swelling, blurry vision, frequency urinary were not recovered, as for the events dizziness, vomiting, vaccination site pain and vaccination site swelling were recovering, while the outcome of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,PVT,,Reflex sympathetic dystrophy (She said the Percocet was prescribed),Medical History/Concurrent Conditions: Leg injury; Migraine (when she was 12 or 13 years old); Rheumatoid arthritis; Spinal cord disorder (in her spine & goes from her spine to her waist & from her waist to both legs & down to her ankles); Spinal cord operation (in her spine & goes from her spine to her waist & from her waist to both legs & down to her ankles); Traffic accident,,,"['Crying', 'Daydreaming', 'Dizziness', 'Dysgeusia', 'Eye swelling', 'Fall', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Malaise', 'Muscle spasms', 'Off label use', 'Pain assessment', 'Pollakiuria', 'Product use issue', 'Swelling', 'Vaccination site pain', 'Vaccination site swelling', 'Vision blurred', 'Vomiting']",1,PFIZER\BIONTECH, 1062087,PA,44.0,M,"Tingling sensation bilateral upper extremities; This is a spontaneous report from a contactable nurse. A 44-year-old male patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) on her left arm, via an unspecified route of administration on 12Jan2021 17:45 at a single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included ibuprofen. Historical vaccine included on 22Dec2020 (first dose) and experienced Bilateral lower extremity numbness, Tingling and Foot pain. It was reported that the patient had tingling sensation bilateral upper extremities on 12Jan2021 18:00. Continues to present day. PCP following prescribed gabapentin. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,PVT,IBUPROFEN,,,,,['Paraesthesia'],2,PFIZER\BIONTECH, 1062088,CA,64.0,F,"Chills; headache; muscle and joint pain; muscle and joint pain; tiredness; nausea; Like a mild flu; This is a spontaneous report from a contactable other healthcare professional (patient). A 64-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL 8982, expiry date: not reported), via an unspecified route of administration, on 26Jan2021 12:15 PM at a single dose on the right arm for COVID-19 immunization. The patient did not receive any other vaccine in four weeks prior to receiving bnt162b2. The patient was not pregnant. She was not diagnosed with covid prior to vaccination. Medical history included high bp (blood pressure) and type 2 diabetes. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EL 1284, expiry date: not reported), on 05Jan2021 10:30 AM on the right arm for COVID-19 immunization (at the age of 64-year-old). On 26Jan2021 04:30 PM, the patient experienced chills, headache, muscle and joint pain, tiredness, nausea; like a mild flu. No treatment was received for the events. Outcome of the events was recovering. The patient was not tested for covid post vaccination. No follow up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Blood pressure high; Type 2 diabetes mellitus,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Influenza', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH, 1062089,OK,40.0,F,"Multiple nodules in the right side of the neck, around 1 cm; This is a spontaneous report from a contactable pharmacist (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 09Jan2021 (at the age of 40years) at single dose for Covid-19 immunization. The patient's medical history was not reported; no known allergies. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced multiple nodules in the right side of the neck, around 1 cm on 15Jan2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/15/2021,6.0,PUB,,,,,,['Neck mass'],1,PFIZER\BIONTECH, 1062090,KY,,F,"My wife took the COVID-19 vaccine at the same time than me and had mild soreness at the injection site; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.It was reported that the patient had mild soreness at the injection site on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021099121 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination site pain'],UNK,PFIZER\BIONTECH, 1062091,,,F,"twinge of pain when she had the shot and that was it; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine and she did not have any symptoms after the injection. The patient just had a twinge of pain when she had the shot and that was it. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain'],1,PFIZER\BIONTECH, 1062092,CT,26.0,F,"Slight pain at the injection site; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; Slight nausea; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 26Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ethinylestradiol, norgestimate (ESTARYLLA), valacyclovir, cyanocobalamin (B12), iron, and colecalciferol (D3). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021, the patient experienced slight pain at the injection site, muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night, and slight nausea. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,WRK,ESTARYLLA; VALACYCLOVIR [VALACICLOVIR]; B12 [CYANOCOBALAMIN]; IRON; D3,,,,,"['Arthralgia', 'Insomnia', 'Myalgia', 'Nausea', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1062093,FL,80.0,M,"Pulled his band aid there was a little blood; This is a spontaneous report from a contactable consumer (wife of patient). An 80-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 27Jan2021 at single dose (left arm) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Her husband had his first dose today but at a different location and when he pulled his band aid there was a little blood. This was his first dose and it was given in his left upper arm. Outcome of event was unknown. Information about Lot/ Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,,,,,,['Vaccination site haemorrhage'],1,PFIZER\BIONTECH, 1062094,NJ,45.0,F,"Diffuse red macular rash over arms legs trunk and chest. Neck also. Face and hands and feet spared; Extremely itchy; This is a spontaneous report from a contactable other health professional. A 45-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 23Jan2021 at 10:30 at a single dose on left arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included modafinil. On 24Jan2021 at 12:00, the patient experienced diffuse red macular rash over arms legs trunk and chest. Neck also. Face and hands and feet spared. Started next day. So far lasting for 4 days. Extremely itchy. The outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/24/2021,1.0,WRK,MODAFINIL,,,,,"['Pruritus', 'Rash macular']",1,PFIZER\BIONTECH, 1062095,NM,40.0,F,"After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; This is a spontaneous report from a contactable other healthcare professional (HCP). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration in the right arm, on 06Jan2021 at a single dose, for Covid-19 immunization. Patient had no relevant medical history and no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Facility type where vaccine was administered was reported as other . On an unspecified date in Jan2021, after the first vaccine the patient had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so. The patient did not receive treatment for the events. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/01/2021,,UNK,LEXAPRO,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Headache', 'Neck pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 1062096,MA,37.0,F,"soreness at injection site; lethargy after the vaccine; headache; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Jan2021 at 13:30 at a single dose on the left arm for COVID-19 immunization. Medical history was reported as none. Concomitant medication included loratadine (CLARITIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 at 16:00, the patient experienced soreness at injection site, lethargy after the vaccine, and headache. The patient received ibuprofen as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,WRK,CLARITIN [LORATADINE],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Headache', 'Lethargy', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 1062097,NM,40.0,F,"arm pain; fever; chills; headache; muscle aches; nausea; This is a spontaneous report from a contactable other HCP. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in right arm on 26Jan2021 at a single dose for COVID-19 immunization. There were no relevant medical history was not reported. there were no known allergies.Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received the first dose ofbnt162b2 on 06Jan2021 in right arm and experienced arm, shoulder and neck pain on my right side along with a lasting headache for a week or so. After the 2nd vaccine, the patient experienced arm pain, fever, chills, headache, muscle aches and nausea on an unspecified date. there outcome of the events was recovering. There was no treatment for the events. The patient was not tested for COVID-19 prior and after the vaccination. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,,,UNK,LEXAPRO,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE,,,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH, 1062098,,,M,Arm is swollen; Pain; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (BNT162B2 reported as COVID SHOT; unknown lot number and expiration date) at unknown age of vaccination via an unspecified route of administration in the arm on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The wife reported that her husband who had a COVID shot Friday in his arm. The patient's arm was swollen and he was having pain. She inquired what can he do for that. The outcome of the event was unknown. � Information on the Lot/Batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Pain', 'Peripheral swelling']",UNK,PFIZER\BIONTECH, 1062099,OH,68.0,F,"the lumpy, red area is not itchy, but it is tingling, and stings sometimes.; stings; lumpy, red area on the opposite shoulder from where she received the COVID-19 Vaccine/lumpy, red raised up bumps area on her left shoulder; lumpy, red area on the opposite shoulder from where she received the COVID-19 Vaccine/lumpy, red raised up bumps area on her left shoulder; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on the right upper arm on 25Jan2021 at 11:30 at a single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medications included Influenza vaccine in Dec2020 and Balance of Nature Fruits as supplement since Jan2021 - she started taking Whole Foods brand Balance of Nature Fruits pills and has been taking them off and on for the last couple weeks. On 27Jan2021, the patient had a lumpy, red area on the opposite shoulder from where she received the COVID-19 vaccine. She said she discovered the lumpy, red raised up bumps area on her left shoulder that morning. She said the lumpy, red area is on the back of her left shoulder, neck and hairline area. She said her husband said the lumpy, red area is a couple square inches in size. She said the lumpy, red area is not itchy, but it is tingling, and stings sometimes. She also asked if what she is experiencing is a side effect of the vaccine. The patient declined any treatment for the events saying she didn't know what to do. The event ""lumpy, red area on the opposite shoulder from where she received the COVID-19 Vaccine/lumpy, red raised up bumps area on her left shoulder"" had not resolved while the outcome of the rest of the events was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/27/2021,2.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Erythema', 'Mass', 'Pain', 'Paraesthesia']",1,PFIZER\BIONTECH, 1062100,,75.0,F,"Pt developed left lower lip paresthesia that radiated to L side of face.; Pt developed left lower lip paresthesia that radiated to L side of face.; This is a spontaneous report from a non-contactable pharmacist. A 75-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), intramuscular on 26Jan2021 at 10:00 at a single dose for covid-19 immunisation. Medical history included transient ischaemic attack (TIA), stroke and chronic kidney disease (CKD) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took gabapentin for facial nerve pain. The patient developed left lower lip paresthesia that radiated to the left (L) side of face on 26Jan2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/26/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Chronic kidney disease (CKD); Stroke; TIA,,,"['Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,OT 1062101,TX,56.0,F,"Sinus pain congestion; Sinus pain congestion; coughing; tiredness; headaches; chills; muscle pain; feeling unwell; back pain; achy all over; very dizzy; nausea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318 and expiry date: unknown), via an unspecified route of administration on the left arm, on 26Jan2021 18:45 at a single dose for COVID-19 immunization. Medical history included High BP, diverticulosis, vertigo and blood clot in artery (healing), allergy to red licorice, hayfever dogs and cats. Patient was not pregnant at the time of vaccination. Concomitant medication included doxycycline, aspirin [acetylsalicylic acid], Multi vit, fiber gummy, and BP meds. There was no other vaccine in four weeks. The patient previously took hydrocodone and prednisone, and experienced allergies. The patient experienced sinus pain and congestion, coughing, tiredness, headaches, chills, muscle pain, achy all over, nausea, felling unwell, very dizzy and back pain on 26Jan2021 19:30. No treatment was received for the events. Outcome was unknown. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/26/2021,0.0,PVT,DOXYCYCLINE; ASPIRIN [ACETYLSALICYLIC ACID],,Medical History/Concurrent Conditions: Allergic rhinitis; Allergic to cats; Allergic to dogs; Allergy; Blood pressure high; Clot blood; Diverticulosis; Vertigo,,,"['Back pain', 'Chills', 'Cough', 'Dizziness', 'Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Nausea', 'Pain', 'Sinus congestion', 'Sinus pain']",1,PFIZER\BIONTECH, 1062102,TN,46.0,F,"injection site is painful; chills; fever with temperature of 99.7 F; headache; tiredness; loss of appetite; joint pain; feeling unwell; received the first dose of Pfizer Covid 19 vaccine on 05Jan2021 and the second dose on 22Jan2021; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) at the vaccination age of 46-year-old via an unspecified route of administration in the left arm on 22Jan2021 13:15 (lot number: EL3302; expiration date: unknown) at a single dose for covid-19 immunization. Medical history included mental disease, seasonal allergy in spring and allergies to sulfa antibiotics. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included aripiprazole (ABILIFY). The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) at the vaccination age of 46-year-old via an unspecified route of administration in the right arm on 05Jan2021 13: 45 (lot number: EJ1685) at a single dose for covid-19 immunization. The patient received the first dose of Pfizer Covid 19 vaccine on 05Jan2021 and the second dose on 22Jan2021. On 23Jan2021 02:00 AM, she had chills, fever with temperature of 99.7 F, headache, tiredness, loss of appetite, joint pain and feeling unwell for 2 days post vaccination. She also mentioned that the injection site was painful on 25Jan2021 for 4 days post vaccination. The patient did not received treatment for the adverse events. The patient has not been covid tested post vaccination. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/22/2021,0.0,SCH,ABILIFY,,Medical History/Concurrent Conditions: Allergy to antibiotic; Mental disorder; Seasonal allergy; Sulfonamide allergy,,,"['Arthralgia', 'Body temperature', 'Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Inappropriate schedule of product administration', 'Malaise', 'Pyrexia', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1062103,AR,31.0,F,"light headed; nervous; really tired; made me really sleepy; i had a few skipped heart beats while laying down; weird/ didn't feel normal; get restless; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9261) via an unspecified route of administration on the left arm on 20Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included having one thyroid and had a benign tumor removed from behind heart when she was young and birth control. Concomitant medication included benzalkonium chloride, sodium chloride (ALIVE) and desogestrel, ethinylestradiol (ISIBLOOM) for birth control. After taking the shot she got light headed as she was walking to her car on 20Jan2021 15:00. Didn't think nothing of it since she was nervous about taking the shot. Then once she got home, she got really tired. She only had one thyroid so the shot made me really sleepy and she had a few skipped heart beats while laying down. After she slept, she felt fine but weird then after being up for a few hours she would get restless again. She got light headed again the next day going to the grocery store then back restless. She didn't feel normal until this Tuesday, she was not feeling weird and she was not as tired as she had been since she took the shot. She had tried to get seen from her doctor but she was booked up. No treatment was received for the events. The facility where the vaccine was administered was in a Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,SEN,ALIVE; ISIBLOOM,,Medical History/Concurrent Conditions: Benign tumor excision (one thyroid and had a benign tumor removed from behind heart when i was young); Birth control; Thyroid disorder (one thyroid and had a benign tumor removed from behind heart when i was young),,,"['Dizziness', 'Extrasystoles', 'Fatigue', 'Feeling abnormal', 'Nervousness', 'Restlessness', 'Somnolence']",1,PFIZER\BIONTECH, 1062104,MO,,M,"dizzy; sinus infection; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number and expiry date unknown, via unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first round of the vaccine and was dizzy on unspecified date. The patient informed that it was not like vertigo but similar. The patient informed that he did not know if it has something to do with what was going on or if it was a sinus infection. The patient informed that he went to bed dizzy. The patient informed that he was dizzy right now but not all the time. The outcome of the events was unknown. Follow-up activities are possible, information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Dizziness', 'Sinusitis']",1,PFIZER\BIONTECH, 1062105,FL,81.0,M,"headache; not eating; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. Medical history included headache on 26Jan2021. There were no concomitant medications. The reporter stated that her husband (patient) received the first dose of the vaccine about two and one-half to three weeks ago and he had some aches and pain but it was not that bad. She reported that a day or two after the first dose he was achy and didn't feel like himself. Then on 26Jan2021, he got a major headache; he would sleep and wake up and sleep again trying to get rid of the headache. She gave him paracetamol (TYLENOL) 650 mg one by mouth and it didn't help. He got the second dose on 27Jan2021 between 07:00 and 09:00AM she was unsure of the arm. He came home and is sleeping now and had a headache on 27Jan2021. She was asking what can she give him for the headache. She also stated that he also was not eating on an unspecified date in Jan2021. She wanted more information on what to do for him. The events did not require a visit to the physician or ER. The outcome of the event headache was not recovered while the outcome of the event not eating was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/01/2021,,MIL,,,Medical History/Concurrent Conditions: Headache,,,"['Feeding disorder', 'Headache']",2,PFIZER\BIONTECH, 1062106,CA,92.0,F,"Lymph nodes hurting/burning pain on chest and breast area/ Her Lymph nodes are tender on the Left Side, it goes down the breast arm; This is a spontaneous report from a contactable consumer reporting for herself. A 92-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration (arm right) on 26Jan2021 at SINGLE DOSE for COVID-19 immunization, at 92 years old. Medical history lung cancer 12 years before from 2009, breast cancer on an unspecified date, and a lump already on the breast from the surgery and she usually get pain there from an unspecified date. She is a cancer survivor. She had surgery for breast cancer on same side, that's where the pain was. She also had a stroke and speech is slurry from an unspecified date. The patient asked to bear with her as she had a stroke in the past and her speech is slurry. She lost the COVID card, she did not even know they gave a card, until somebody told her that they had their card. She lives in a Senior citizen facility, and she does not remember any card. They just gave her information sheets. It was reported that the patient had the vaccine and she was having a lot of pain on the left side, however she got the vaccine on the right side. She had surgery for breast cancer on same side, that's where the pain was, however the vaccine was on the other arm. Patient stated that she thinks it was the lymph nodes, she does not know what to do about it, since she is a Cancer survivor. The patient requested the call handler to talk slow, she is 92 years old. She cannot call the doctor because he is retired and so she does not have a doctor. The patient expressed that its especially in the Lymph nodes, she read the papers that she got, she thought this is common. Her First Dose was on 26Jan2021, probably around 9:30AM or 10AM. The Lymph nodes began hurting on 26Jan2021, it was a burning pain on chest and breast area. She took a Vicodin and it went away and did not bother her for the rest of the day, but it was bothering her this morning and it woke her up. She has a lump already on the breast from the surgery and she usually get pain there, but this is not the same pain today. As of reporting time, it was different, it was a stronger pain, it goes down the breast arm. Her Lymph nodes are tender on the Left Side which is the same side she had surgery on in the past. She got the vaccine on the right arm. Outcome of the event was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,UNK,,,"Medical History/Concurrent Conditions: Breast cancer (She had surgery for breast cancer on same side, that's where the pain is.); Breast pain female; Lung cancer; Slurred speech; Stroke; Surgery (She had surgery for breast cancer on same side, that's where the pain is.)",,,['Lymph node pain'],1,PFIZER\BIONTECH, 1062107,CA,38.0,F,"axillary lymphadenopathy x 2 weeks right side (same side as first injection).; nausea; vomiting; transitory trigeminal neuralgia - right sided; This is a spontaneous report from a contactable physician (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular at the right arm on 30Dec2020 14:30 at single dose for COVID-19 immunization. The patient has no medical history. The patient has no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included influenza vaccine (FLU) on 10Dec2020 at the left arm. The patient experienced axillary lymphadenopathy for 2 weeks right side (same side as first injection), nausea, vomiting, and transitory trigeminal neuralgia - right sided; all on 01Jan2021. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included nasal swab (COVID PCR): negative on 19Jan2021. The patient recovered from the event axillary lymphadenopathy on 15Jan2021 and recovered on an unspecified date for the rest of the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/01/2021,2.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Lymphadenopathy', 'Nausea', 'SARS-CoV-2 test', 'Trigeminal neuralgia', 'Vomiting']",1,PFIZER\BIONTECH,OT 1062108,MS,82.0,M,"Diarrhea; his arm was a little sore; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER BIONTECH COVID-19 VACCINE; lot number: EL3247; expiration date: unknown) at the vaccination age of 82-year-old intramuscularly in the left arm on 25Jan2021 14:00 at a single dose for COVID-19 vaccination (COVID-19 immunization). The patient's medical history and concomitant medications were none. The patient did not received other vaccine within 4 weeks prior to vaccination. The wife reported that her husband got the first dose of the Covid-19 Vaccine on 25Jan2021 about 14:00 and did not have any reaction except his arm was a little sore on 25Jan2021 18:00. It is sore if he rubs the area, but has gotten better She said that last night, he developed diarrhea at about 22:30 26Jan2021. She inquired if this is a coincidence, he got the diarrhea or is it a side effect from the shot. She added that the diarrhea started about 36 hours after he got the first dose. He had the diarrhea at 22:30 26Jan2021, he had it again at 02:00 27Jan2021, and again at 07:00 27Jan2021 and he has not had it since. She said that her husband was saying he thinks it was getting better. She mentioned that after he received the vaccine, they waited for 15 minutes to make sure there was no reaction. She added that the vaccination facility type was health department drive through vaccination. The adverse events did not require emergency room or physician office visit. The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Diarrhoea', 'Pain in extremity']",1,PFIZER\BIONTECH,OT 1062109,MI,81.0,F,"weight was 236-238 and bounces back and forth; Started getting real dizzy that comes and goes/ if she moves too fast that the dizziness comes and goes; Right arm is sore and not tender; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249 expiration date: May2021, via an unspecified route of administration on 26Jan2021 at a single dose in the right arm for COVID-19 immunization. Medical history included heart problem from Nov2019 and ongoing and angina pectoris. Concomitant medication included a lot of pills for her heart problem. She was on blood thinners, sugar pills, and uric acid because of the diuretics. The patient stated that she got her shot yesterday (26Jan2021) a little after 1. Later this morning (27Jan2021), that she started getting real dizzy that comes and goes. She was reading the list and dizziness was one of more serious side effects. She wanted to know what to do about it, it was one of things. She has another shot coming up on 16Jan (as reported). The patient further mentioned that her right arm was sore and not tender on 27Jan2021. If she moves too fast that the dizziness comes and goes. Her weight was 236-238 and bounces back and forth because she was on diuretics. The outcome of the events dizziness was not recovered, right arm was sore was recovering while for weight was 236-238 and bounces back and forth was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,UNK,,Heart disorder (Verbatim: heart problem),Medical History/Concurrent Conditions: Angina pectoris,,,"['Dizziness', 'Pain in extremity', 'Weight', 'Weight fluctuation']",UNK,PFIZER\BIONTECH, 1062110,FL,71.0,F,"With the first dose she felt the little warmth or gush of the medication going in; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration at the upper left arm on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. With the first dose she felt the little warmth or gush of the medication going in on 06Jan2021, not pain but she could feel it going in but with this second shot there was nothing and no blood. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/06/2021,0.0,UNK,,,,,,['Vaccination site warmth'],1,PFIZER\BIONTECH, 1062111,NY,40.0,F,"Her hand is a purple color; Her skin feels like a BP cuff is on it; entire left arm is swollen and red; entire left arm is swollen and red; Her entire left arm, which is the arm that received the vaccine is swollen and red. It feels like the circulation is being cut off; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL8982 and Expiration date: 31May2021), via an unspecified route of administration at the left arm on 21Jan2021 at a single dose for covid-19 immunization. The patient's has no medical history. There were no concomitant medications. On 22Jan2021, her entire left arm, which is the arm that received the vaccine is swollen and red. It feels like the circulation is being cut off. It hasn't been seeming to get better. The first time she noticed it was the morning after the vaccine. Her entire arm was swollen. She thought it would dissipate. At times it has kind of gotten better, but then the swelling keeps coming right back. Like right now her arm was uncomfortable in her coat. On an unspecified date, her hand was purple color. Her skin feels like a BP cuff was on it. She has not had treatment for it. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/22/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Erythema', 'Peripheral swelling', 'Peripheral vascular disorder', 'Skin discolouration', 'Skin discomfort']",1,PFIZER\BIONTECH, 1062112,MO,28.0,F,"soreness at the injection site; Headache; elevated temperature (100.2 F); This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration in left arm on 26Jan2021 08:30 at a single dose for covid-19 immunization. Medical history was reported as none. There was no other vaccine administered to the patient in four weeks. No known allergies. Patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. On 27Jan2021 at 07:00, patient experienced soreness at the injection site, headache and elevated temperature (100.2 F). Outcome of the events was unknown. Patient was given the vaccine in a workplace clinic. The patient has not tested with Covid since vaccination. Information about Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/27/2021,1.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Body temperature', 'Body temperature increased', 'Headache', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1062113,IL,58.0,F,"This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982), via an unspecified route of administration by injection once to left arm, upper part, on 26Jan2021 at a single dose for COVID-19 immunization. The patient has no medical history. There were no concomitant medications. The patient experienced tingling on right side by cheek bone on 27Jan2021 and she did not have it yesterday, and the shot was on the left side, later clarified as the left arm. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Paraesthesia'],UNK,PFIZER\BIONTECH, 1062114,OH,37.0,F,"HSV 1 eruption and subli; withdrawal bleeding 3 days late and heavier and longer than usual; migraine; Left index finger petechiae; had an insect bite; lymphadenopathy on the left deltopectoral (1x1 cm tender freely mobile) and on the left supraclavicular (2x1 cm tender freely mobile); temperature was 101 F; Acne flare-up; no withdrawal bleeding and she was on oral contraceptive pill (OCP)/withdrawal bleeding 3 days late; woke up at 2:00 AM and 2:35 AM because of the tenderness rolling over and she had to take central analgesia to be able to sleep; puffy face; tenderness at the site of injection; Constipation; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on the left arm, on 06Jan2021 15:45, at single dose, for covid-19 immunization. The patient has no medical history; unknown if there were any allergies. Concomitant medications included oral contraceptive pill (OCP) and multivitamins. The patient had no Covid prior to vaccination. She did not receive any other vaccines within 4 weeks prior to the Covid vaccine. She took pre-vaccination analgesia. The vaccine was given at the hospital. On 06Jan2021 (day 0) she experienced tenderness at the site of injection. She also experienced constipation on 06Jan2021. However, she couldn't ""comment"" about temperature since she was taking NSAIDs. She woke up at 2:00 AM and 2:35 AM on 07Jan2021 (day 1) because of the tenderness rolling over and she had to take central analgesia to be able to sleep. On 07Jan2021 she experienced tenderness at the site of injection and; puffy face but it wasn't angioedema. Her O2% was ""99-98% repositioning"" on 07Jan2021. She still had constipation and still couldn't comment about temperature since she was taking NSAIDs. On 08Jan2021 (day 2) she had an acne flare-up; and no withdrawal bleeding and she was on oral contraceptive pill (OCP). For the constipation she started on OTC fiber gum. On 09Jan2021 (day 4) she experienced lymphadenopathy on the left deltopectoral (1x1 cm tender freely mobile) and on the left supraclavicular (2x1 cm tender freely mobile) which hadn't resolved. She still was experiencing constipation. Her temperature was 101 F on 09Jan2021. On 10Jan2021 (day 5) she had withdrawal bleeding 3 days late and heavier and longer than usual, migraine, constipation, and left index finger petechiae because on ""23/11"" she had an insect bite on 10Jan2021. On 11Jan2021 (day 6) her lymphadenopathy on the left posterior cervical (1x1 cm tender freely mobile) hasn't resolved; she still had migraine and was now back to regular bowel habit. On 15Jan2021 (day 10) she had HSV 1 ""eruption and subli"". She received treatment (also reported as symptomatic treatment) for all these adverse events. At the time of the report, she recovered from constipation on 11Jan2021 with lasting effects; while she also recovered from all the other remaining adverse events on Jan2021 with lasting effects. She has not been Covid-tested post-vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/06/2021,0.0,PVT,,,,,,"['Abnormal withdrawal bleeding', 'Acne', 'Arthropod bite', 'Body temperature', 'Constipation', 'Herpes simplex', 'Lymphadenopathy', 'Middle insomnia', 'Migraine', 'Oxygen saturation', 'Petechiae', 'Pyrexia', 'Swelling face', 'Vaccination site pain', 'Withdrawal bleed']",1,PFIZER\BIONTECH, 1062115,FL,81.0,M,"achy / aches and pain; didn't feel like himself; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The reporter stated that her husband (patient) received the first dose of the vaccine about two and one-half to three weeks ago and he had some aches and pain but it was not that bad. She was unsure of the exact day or time and does not know which arm. She reported that a day or two after the first dose he was achy and didn't feel like himself. He didn't say much about it. Then yesterday 26Jan2021 he got a major headache after the second dose; he would sleep and wake up and sleep again trying to get rid of the headache. She gave him Tylenol 650mg one by mouth and it didn't help. Outcome of the events was unknown. Information about batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,MIL,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Feeling abnormal', 'Pain']",1,PFIZER\BIONTECH, 1062116,,,F,"Feels terrible now; Sinus headache; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient's husband) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date, after the first dose of vaccination, the patient had felt ""terrible now""; and had sinus headache. The outcome of the events, 'felt terrible' and 'sinus headache', was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Malaise', 'Sinus headache']",1,PFIZER\BIONTECH, 1062117,,29.0,F,"swollen lymph nodes around collarbone and neck; This is a spontaneous report from a non-contactable consumer (patient). A 29-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3246 and expiration date unknown), via an unspecified route of administration on the left arm on 14Jan2021 at a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), probiotics (PROBIOTICS) and multivitamin. The patient had no other vaccine in four weeks and was not diagnosed with COVID-19 prior to the vaccination. The patient experienced swollen lymph nodes around collarbone and neck on 20Jan2021. No treatment was administered for the event. The patient underwent lab tests and procedures which included nasal swab: negative on 04Jan2021. The event had not resolved. The event required a physician office visit. No follow-up attempts are possible; information about batch/lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/20/2021,6.0,PVT,ALLEGRA; PROBIOTICS,,,,,"['Lymphadenopathy', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1062118,TN,53.0,F,"Nausea; Dizzy; left arm soreness; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: May2021), intramuscular on the left arm, on 08Jan2021 16:29, at single dose, for Prevention/COVID-19 immunization, at a public health department. There were no medical history and concomitant medications. The patient did not receive other vaccinations within 4 weeks. On 09Jan2021 at 08:00, the patient experienced left arm soreness. On 27Jan2021 at 07:00, the patient felt dizzy. Shortly after, at 07:15, the nausea started. The patient wanted to know if these could be side effects and would it still be okay to get the scheduled second dose on 29Jan2021. The patient also asked if she can get the second dose if she has a fever on the day she is supposed to get the second dose. The events did not require emergency room or physician's office visits. The patient was recovering from the events. The reporter assessed the events as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PUB,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dizziness', 'Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH,OT 1062119,IN,22.0,F,"For 24 hours I had muscle spasms down the middle of my back and in my neck; severe malaise; This is a spontaneous report from a contactable nurse (patient). A 22-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1824; expiry date: unknown) via an unspecified route of administration in the right arm, on 20Jan2021 at 10:00, at a single dose, for Covid-19 immunization. Other medical history included depression, anxiety, and hypothyroidism. The patient had no known allergies. Concomitant medications included sertraline, prednicarbate (TOPIMAX), levothyroxine, and ethinylestradiol, norelgestromin (XULANE). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EI1284) in the right arm, on 26Dec2020 at 06:15 AM, for Covid-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. On 21Jan2021, at 12:00 AM, for 24 hours, the patient had muscle spasms down the middle of her back and in her neck, and severe malaise. The patient did not receive therapy for the events. Outcome of the events was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,01/21/2021,1.0,UNK,SERTRALINE; TOPIMAX [PREDNICARBATE]; LEVOTHYROXINE; XULANE,,Medical History/Concurrent Conditions: Anxiety; Depression; Hypothyroidism,,,"['Malaise', 'Muscle spasms']",2,PFIZER\BIONTECH, 1062120,,,U,"4 inch area of erythema around the injection site; 4 inch area of erythema around the injection site/There was no induration or hives, nothing other than pain due to injection; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the first shot and over 4 days developed a 4-inch area of erythema around the injection site. There was no induration or hives, nothing other than pain due to injection. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Vaccination site erythema', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1062121,DE,,M,"body aches; Low grade fever; swelling of upper lip/recurrent swelling of the upper lip; This is a spontaneous report from a contactable physician. A 54-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on Jan2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history included benign prostatic hyperplasia from an unknown date and unknown if ongoing. Concomitant medication included morniflumate (FLOMAX [MORNIFLUMATE]) for benign prostatic hyperplasia. It was also reported that patient was not on an ACE inhibitor. The physician reported that the patient received the second dose of the Pfizer COVID 19 vaccine two weeks ago today (unspecified date). Eleven to thirteen hours later, the patient had the typical symptoms including body aches and low grade fever. Patient also experienced swelling of the upper lip. All of these effects resolved within 24 hours and the patient had recovered completely. Then 14 days later, the patient had recurrent swelling of the upper lip again. It was stated that the events were not serious. Outcome of the events 'body aches' and 'low grade fever' was recovered; outcome of the event 'swelling of upper lip/recurrent swelling of the upper lip' was not recovered. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,,,UNK,FLOMAX [MORNIFLUMATE],,Medical History/Concurrent Conditions: Benign prostatic hyperplasia,,,"['Lip swelling', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1062122,NC,81.0,F,"itching at her head, face and shoulders and the back; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: EL9261), via an unspecified route of administration on the right arm on 26Jan2021 10:30 at SINGLE DOSE as COVID-19 immunization at the hospital. Medical history heart attack, ongoing bone disorder (reported as bone), ongoing blood pressure abnormal (reported as blood pressure), ongoing pain in leg, ongoing blood cholesterol abnormal (reported as cholesterol), ongoing allergy, and ongoing blood clots in leg. The patient was also allergic to sulfa. Ongoing concomitant medications included hydrochlorothiazide, triamterene (MAXZIDE) since 2011 (taking for 10 years) and for blood pressure, cetirizine hydrochloride (ZYRTEC) from unknown date (taking for long time) for allergy, losartan (LOSARTAN) since 2016 (taking for 5 years) for cholesterol, potassium (POTASSIUM) from unknown date (taking for long time) for pain in leg, metoprolol tartrate (LOPRESSOR) since 2011 (taking for 3 years) for blood pressure, omeprazole (PROTONIX) since 2011 (taking for 3 years) for blood clots in leg, fish oil (FISH OIL) from unknown date and indication, acetylsalicylic acid (ASPIRIN) since 2001 (taking for 20 years) for heart attack, colecalciferol (D3) since 2016 (taking for 5 year) for calcium supplementation reported as (calcium and body build up), and calcium (CALCIUM) from unknown date for bones. The patient first dose of the Pfizer COVID 19 vaccine on 26Jan2021 at 10:30AM in the right arm. She noticed about 9PM last night, she started itching at her head, face, shoulders and back. The itching only lasted for a little over an hour (26Jan2021 10:00 PM). She took some diphenhydramine (BENADRYL) and it helped, gave her some relief. She was fully recovered today 27Jan2021. She was scheduled for the next dose 16Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PVT,MAXZIDE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LOSARTAN; POTASSIUM; LOPRESSOR; PROTONIX [OMEPRAZOLE]; FISH OIL; ASPIRIN [ACETYLSALICYLIC ACID]; D3; CALCIUM,Allergy; Blood cholesterol abnormal; Blood pressure abnormal; Bone disorder; Pain in leg; Thrombosis,Medical History/Concurrent Conditions: Heart attack; Sulfonamide allergy,,,['Pruritus'],1,PFIZER\BIONTECH, 1062123,TX,79.0,M,"Fever; Chills; extreme weakness; so weak he couldn't stand up out of a chair; extreme weakness; so weak he couldn't stand up out of a chair; felt really bad; This is a spontaneous report from a contactable consumer (patient himself). A 79-year-old male patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; EL3247), via an unspecified route of administration in the left arm near the shoulder on 16Jan2021 at about 2-3:00 PM as a single dose for COVID-19 immunization (also reported as to protect himself; hopefully). The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines on the same day as BNT162B2 or even four weeks prior and had no problems with vaccines in the past. The patient experienced fever, chills, extreme weakness; so weak he couldn't stand up out of a chair, and felt really bad on 26Jan2021. He had a fever a little over 100 degrees, extreme weakness. He was so week he couldn't stand up out of a chair. He also had chills and just felt really bad. The patient thinks he was over it, he hoped. The events did not require any visit to the Emergency Room or Physician's office. Outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/26/2021,10.0,MIL,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Body temperature', 'Chills', 'Dysstasia', 'Malaise', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1062124,FL,78.0,F,"she has been shrinking; the COVID-19 Vaccine injection site was a little itchy, red, and hot when she first noticed the adverse reaction on 15Jan2021; the COVID-19 Vaccine injection site was a little itchy, red, and hot when she first noticed the adverse reaction on 15Jan2021; the COVID-19 Vaccine injection site was a little itchy, red, and hot when she first noticed the adverse reaction on 15Jan2021; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number 61R84), via an unspecified route of administration on 14Jan2021 at 12:00 (at the age of 78-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included macular degeneration from an unknown date (for which patient received macular degeneration shot in her eye on 11Jan2021. The shot was the medication ""Elyce""), high blood pressure and thyroid condition (both for which patient takes unspecified medications) and bad back for which patient received epidural (unspecified medication) on 13Jan2021. Concomitant medications Elyce (as reported) for macular degeneration, epidural (unspecified medication) for back pain, and unspecified mediations for high blood pressure and thyroid condition. The patient did not receive any other vaccines within four weeks prior to the vaccination and had no additional vaccines administered on the same date of the vaccination. On 15Jan2021 the patient experienced vaccine injection site was a little itchy, red, and hot when she first noticed the adverse reaction on the second day, 15Jan2021. She said the COVID-19 Vaccine injection site stayed warm and itchy for 3 days. She said she noticed the red spot was still at the COVID-19 Vaccine injection site this morning, and asked does she need to worry about the red spot. She clarified the redness at the vaccine injection site is a half circle, and the vaccine injection site is not burning or itching. The patient did not receive any treatments for the vaccine injection site was a little itchy, red, and hot> The patient stated she ""has been shrinking"" from an unknown date. The patient also reported she has a history of a bad back and she had an epidural the day before getting her first COVID-19 Vaccine dose. She clarified she had the epidural on 13Jan2021. The patient stated she does not have the epidural medication name, dose, NDC, Lot and Expiration Date, since the epidural was given at the orthopedist's office. She said she received a notice from her orthopedist, who administered the epidural on 13Jan2021, stating that Pfizer recommended not to have an epidural when having the COVID-19 Vaccine because the epidural may not be as effective. She said she is not going to go back for her second epidural with the orthopedist, but plans to have her second COVID-19 Vaccine dose. She clarified that the letter from her orthopedist stated she can schedule her next epidural a week after receiving the COVID-19 Vaccine. The patient stated she was more concerned about getting her second dose of the COVID-19 Vaccine than getting a second epidural with her orthopedist. The patient reported she still had a half dollar sized red mark at the COVID-19 Vaccine injection site. The clinical outcomes of the vaccine injection site was a little itchy, red, and hot were recovering. The outcome of the event she has been shrinking was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/15/2021,1.0,OTH,,,"Medical History/Concurrent Conditions: Back disorder (patient received epidural (unspecified medication) on 13Jan2021); Blood pressure high (Reported she has high blood pressure and a thyroid condition that she takes medications for.); Macular degeneration (patient received macular degeneration shot ""Elyce"" in her eye on 11Jan2021.); Thyroid disorder (Reported she has high blood pressure and a thyroid condition that she takes medications for.)",,,"['Body height', 'Body height decreased', 'Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site warmth']",1,PFIZER\BIONTECH, 1062125,OH,85.0,M,"had trouble with his stomach in the bowels while sleeping; arm sore; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that his arm was sore the first night (23Jan2021) and did not take anything for it. On Monday night (25Jan2021), he had trouble with stomach in bowels while sleeping. He wanted to know if this was an occurrence from the vaccine or if it was a random occurrence. In all things that he read, diarrhea like symptoms were not mentioned. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,01/23/2021,0.0,UNK,,,,,,"['Gastrointestinal disorder', 'Pain in extremity']",1,PFIZER\BIONTECH, 1062126,,34.0,F,"Sore arm; mild headache; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at the right arm on 19Dec2020 08:45 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced sore arm, mild headache, and nausea after the first dose on an unspecified date with outcome of not recovered. The patient did not receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/19/2020,,,PVT,,,,,,"['Headache', 'Nausea', 'Pain in extremity']",1,PFIZER\BIONTECH, 1062127,,49.0,F,"arm pain/soreness; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EK9231), intramuscular at the left upper arm on 05Jan2021 10:20 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. On 05Jan2021, the patient experienced arm pain/soreness she took some Tylenol, not that she needed too much. She recovered from the arm pain/soreness within a day or two days. It was not a big deal. The patient weight was 157-158lbs on an unspecified date. The outcome of the event was recovered on Jan2021. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Pain in extremity', 'Weight']",1,PFIZER\BIONTECH,OT 1062129,FL,,M,"arm was sore; This is a spontaneous report from a contactable consumer. An 88-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got his on 14Jan2021, and his arm was sore in Jan2021 but he did not have any redness, itchiness, or warmth. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/01/2021,,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1062130,PA,26.0,F,"fever; chills; headache; overall fatigue; pain and tenderness at injection site as well as in the armpit underneath the injection site; pain and tenderness at injection site as well as in the armpit underneath the injection site; patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine; patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZERBIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 26-year-old intramuscularly in the left arm on 26Jan2021 12:15 at a single dose for covid-19 immunization. Medical history included autoimmune thyroiditis (not yet clear if Hashimoto's or Graves), appendicectomy and pyelonephritis. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included methimazole, atenolol, valaciclovir hydrochloride (VALACYCLOVIR HCL), ethinylestradiol, norgestimate (NORGESTIMATE & ETHINYL ESTRADIOL) and magnesium. The patient did not receive other vaccine in four weeks. The patient previously took azithromycin but drug allergy. The patient received the first dose of of bnt162b2 (BNT162B2 reported as PFIZERBIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 26-year-old intramuscularly in the left arm on 05Jan2021 02:15 PM at a single dose for covid-19 immunization but had pain and tenderness at the injection site. It was reported that the patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine in a hospital on 26Jan2021 12:15. On 27Jan2021 12:00 AM, the patient had fever, chills, headache, overall fatigue, pain and tenderness at injection site as well as in the armpit underneath the injection site. The events required treatment which included acetaminophen. The outcome of the events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,PVT,METHIMAZOLE; ATENOLOL; VALACYCLOVIR HCL; NORGESTIMATE & ETHINYL ESTRADIOL; MAGNESIUM,,Medical History/Concurrent Conditions: Appendectomy; Autoimmune thyroiditis; Pyelonephritis,,,"['Axillary pain', 'Chills', 'Fatigue', 'Headache', 'Off label use', 'Product use issue', 'Pyrexia', 'Vaccination site pain']",2,PFIZER\BIONTECH,OT 1062131,SC,52.0,M,"Fever; Chills; Body Ache; Pain in face; Pain in back; pain in hip; Headache for 2 days; Vivid nightmares; Sweats; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EL3249, expiry date: not reported), via an unspecified route of administration, on 25Jan2021 03:00 PM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. Medical history was none. The patient was not diagnosed with covid prior to vaccination. He had no known allergies. Concomitant medications were not reported. On 26Jan2021 01:15 AM, the patient experienced fever, chills, sweats, body ache, pain in face, pain in back, pain in hip, headache for 2 days, vivid nightmares. 2 days later (at the time of report, 27Jan2021), the patient still had low grade fever, sweating, body ache and headache. No treatment was received for the reported adverse events. Outcome of the events was reported to be recovering. The patient was not tested for covid post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Back pain', 'Body temperature', 'Chills', 'Facial pain', 'Headache', 'Hyperhidrosis', 'Nightmare', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 1062132,FL,64.0,M,"Rash all over his body; rash which is red patchy tiny blistery things; rash which is red patchy tiny blistery things; pain of the rash and blisters; Itching; Shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EH9899) solution for injection, via an unspecified route of administration on 21Jan2021 at a single dose for Covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient experienced shoulder pain on 22Jan2021; itching started on 23Jan2021; rash all over his body which has worsened, rash which was red patchy tiny blistery things on 24Jan2021. Patient further reported that he had a rash over his entire body. It started as an itch on his legs which developed into more itching which turned into a rash which was red patchy tiny blistery things. Now it was on his arms, back, belly, neck, and legs. He had shoulder pain and it was hurting the day after he got the vaccine on Friday 22Jan2021. Rash started on Sunday 24Jan2021, it was like a chicken pox type rash. It was like red dots that become sensitive and look slightly blistered. Shoulder pain: this was nothing compared to the pain of the rash and blisters (24Jan2021). He had taken off the bandage and was sore. He was not even sure if he was still sore or not because he was only paying attention to everything else. It was overwhelming. Treatment: He called his doctors and they said that he should use Calamine lotion as a temporary soother for itch and rashes. They also told him to take Benadryl and his doctor prescribed Prednisone. Outcome of the event shoulder pain was unknown while the other events was not recovered. No follow-up activities are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/22/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Pain', 'Pruritus', 'Rash', 'Rash erythematous', 'Rash vesicular']",1,PFIZER\BIONTECH, 1062133,TN,78.0,M,"Felt as though truck kept turning over, but it was all in his head; Felt as though truck kept turning over, but it was all in his head; Was hot and everything; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: PK12ER/EL9261; Expiration date was not reported) on 26Jan2021 (11:30) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization/to not get COVID at the public health department. The patient had no relevant medical history and concomitant medications. The patient had no history of problems with vaccines in the past. On 27Jan2021, the patient had felt as though a truck kept turning over, but it was all in his head; and was ""hot and everything"". The outcome of the events, 'felt as though a truck kept turning over, but it was all in his head' and '""hot and everything""', was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,PUB,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Feeling abnormal', 'Feeling hot', 'Thinking abnormal']",UNK,PFIZER\BIONTECH, 1062134,,50.0,F,"sick; temperature of 101 degrees; headache/frontal type of headache; This is a spontaneous report from a contactable nurse (patient). A 50-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3249 and expiration date unknown), intramuscular on 26Jan2021 at 10:20 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), batch/lot number: EK9231, intramuscular injection in left upper arm on 05Jan2021 as COVID-19 immunization and only had arm pain/soreness. As a nurse, the patient has given tons of vaccines. On 26Jan2021, she was given her second dose of COVID-19 vaccine around 10:20 a.m. She didn't hurt right away, it started later on. By 6pm, she got home, so sick and had a temperature of 101 degrees. She didn't go to work as she has been running a temperature and she has taken Tylenol. She knows the vaccine works the same, but everybody acts different. The patient also asked if a high temperature of 101 degrees a common side effect and if it is a normal reaction and how long it typically last. The patient states she has never been so sick like this in her life. The patient never gets sick and wanted to know if this is a common thing. She hasn't called her primary doctor. She took Tylenol Extra Strength, 6 or 7pm, also in the middle of the night and then again at 9am the following morning. Her fever has gone down a little bit, but the headache was so bad. It's like a frontal type of headache and it hurts so bad. The headache also began around 6pm yesterday and has converted into fever. The patient wanted to know if it is common to have this type of reaction. The patient is getting so tired and declined to continue with the report, stating she just wants to lay down. The event temperature of 101 degrees was resolving while the outcome of the rest of the events was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'Headache', 'Illness', 'Pyrexia']",2,PFIZER\BIONTECH,OT 1062135,NM,53.0,F,"swelling and soreness at the injection site; soreness at injection site; red, and a little swollen at the injection site; felt itchy at the injection site; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249 and expiry date: unknown), intramuscular on the right arm near shoulder on 19Jan2021 09:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. There were no other vaccine received within 4 weeks prior to COVID vaccination. After she got a tetanus shot (probably needs another since it had been ten years) her arm/ muscle was sore. Patient had typical swelling and soreness at the injection site on Jan2021that went away within a couple of days and then did not have any symptoms. Then today all of a sudden it felt sore, red, and a little swollen at the injection site again. It has been more than a week since the symptoms initially resolved and now they have reemerged. It felt itchy at the injection site, it had a raised red area that was itchy on Jan2021. She did go running this morning and has been running several times, she went running the day after she got the vaccine. Events did not require emergency room nor a visit to the physician's office, and no treatment was given. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,01/01/2021,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Vaccination site erythema', 'Vaccination site pain', 'Vaccination site pruritus', 'Vaccination site swelling']",1,PFIZER\BIONTECH,OT 1062136,,74.0,F,"runny eyes, very itchy, discharge, and was like pink eye; runny eyes, very itchy, discharge, and was like pink eye; runny eyes, very itchy, discharge, and was like pink eye; This is a spontaneous report from a non-contactable consumer (patient herself). A 74-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: EL9261), via an unspecified route of administration in the left arm on 25Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination, did not receive any other vaccine in four weeks, and was not pregnant. The patient experienced runny eyes, very itchy, discharge, and was like pink eye on 25Jan2021. It was reported that the events started about six hours after vaccine shot and lasted 48 hours. The patient had not tested positive for COVID-19 post vaccination. The patient did not receive any treatment for the events. Outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,UNK,,,,,,"['Conjunctivitis', 'Eye discharge', 'Eye pruritus']",1,PFIZER\BIONTECH, 1062137,CA,56.0,F,"legs cramps; stomachaches; has a history of heart palpitations/she felt her heart started rushing more, she had rapid heartbeat; sore arm; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the left arm, on 09Jan2021, at single dose, for COVID Prevention/COVID-19 immunization. Medical history included heart palpitations. Concomitant medication included unspecified medication for heart palpitations. The patient did not receive any other vaccines on the same day as BNT162B2. On 09Jan2021 (the same day as the patient received the vaccine), she developed sore arm which went on about for three days. The patient reported she put rubbing alcohol on it and that helped. On 12Jan2021 (day three after the vaccine), the patient experienced leg cramps and stomachache which went on about for 24 hours. The patient reported that she has a history of heart palpitations, but when she got the vaccine, on 12Jan2021 (day three after the vaccine), she felt her heart started rushing more, she had rapid heartbeat, but then she got it under control. She reported she has some pills for that, so she took an extra dose of her pills and that helped out with the palpitation. The patient recovered from the event sore arm on 12Jan2021; from leg cramps and stomachaches on 13Jan2021; and from ""has a history of heart palpitations/she felt her heart started rushing more, she had rapid heartbeat"" on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Palpitations,,,"['Abdominal pain upper', 'Heart rate', 'Muscle spasms', 'Pain in extremity', 'Palpitations']",1,PFIZER\BIONTECH, 1062138,,34.0,F,"intense body aches; fever; joint pain; several episodes of tachycardia; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration on 09Jan2021 10:00 at a single dose on right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 19Dec2020 at 08:45 AM on right arm (lot number: EH9899) for COVID-19 immunization and experienced sore arm, mild headache/nausea. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Jan2021 20:00, the patient experienced intense body aches, fever, joint pain; and approximately 1 week after through more than 2 weeks after (Jan2021) had several episodes of tachycardia. No treatment was received for the adverse events. The patient has not recovered from the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/01/2021,,PVT,,,,,,"['Arthralgia', 'Pain', 'Pyrexia', 'Tachycardia']",2,PFIZER\BIONTECH, 1062139,PA,59.0,F,"Body ache; Headache; Tiredness; Sore arm; Insomnia; Chills in eve; This is a spontaneous report from a non-contactable healthcare professional (patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 22Jan2021 (12:45) at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), calcium, magnesium, vitamin d nos (CAL MAG), calcium carbonate;colecalciferol;phytomenadione (VIT D+K) and fish oil (OMEGA 3). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported) on 30Dec2020 (when the patient was 59 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 22Jan2021, the patient had sore arm; insomnia; and chills in the evening (""eve""). On 23Jan2021, the patient had body ache, headache and tiredness. The patient did not receive any treatment for the events. The outcome of the events, 'sore arm', 'insomnia', 'chills', 'body ache', 'headache' and 'tiredness', was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,PVT,WELLBUTRIN; CAL MAG; Vit D+K; Omega 3,,,,,"['Chills', 'Fatigue', 'Headache', 'Insomnia', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH, 1062140,MO,37.0,F,"arm started to get sore; This is a spontaneous report received from a contactable consumer (patient). A 37-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date: unknown), via an unspecified route of administration on the left arm, on 26Jan2021 12:00, at single dose, for covid-19 immunization, at the workplace clinic. There were no medical history and concomitant medications. The patient has no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive other vaccines in four weeks. On 26Jan2021 at 17:00, the patient's arm started to get sore and continued to get more sore throughout the evening. It was much better when she woke up in the morning of 27Jan2021, and the pain was fully resolved by 17:00 on 27Jan2021. No treatment was given for the event. The patient recovered from the event on 27Jan2021 at 17:00.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1062141,,40.0,M,"Soreness around the injection site for approximately 30 hours.; This is a spontaneous report from a non-contactable consumer. A 40-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EN5318), via an unspecified route of administration in right arm on 26Jan2021 09:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced soreness around the injection site for approximately 30 hours on 26Jan2021 10:15 with outcome of recovered. There was no treatment for the event. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1062142,NY,22.0,F,"Severe joint pain; chills; muscle weakness, causing minimal ability to walk (bed bound); muscle weakness, causing minimal ability to walk (bed bound); This is a spontaneous report from a contactable nurse (patient). A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on the left arm on 26Jan2021 at a single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus and attention deficit hyperactivity disorder (ADHD). Concomitant medication included dextroamphetamine (dexamfetamine) and ethinylestradiol, norgestimate (TRI ESTARYLLA). The patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 07Jan2021 on the right arm On 27Jan2021 10:00, the patient experienced severe joint pain and muscle weakness, causing minimal ability to walk (bed bound) and chills. No treatment was given for the events. The patient was recovering from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,PVT,DEXTROAMPHETAMINE [DEXAMFETAMINE]; TRI ESTARYLLA,,Medical History/Concurrent Conditions: ADHD; Type 1 diabetes mellitus,,,"['Arthralgia', 'Chills', 'Gait disturbance', 'Muscular weakness']",2,PFIZER\BIONTECH, 1062143,TX,78.0,F,"lost 3 pounds; chills; Sheets were soaking wet, she kept having to urinate; Kept having to urinate; Diarrhea; Getting very hot and cold; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, lot number: EL9262, via an unspecified route of administration on 07Jan2021 at a single dose in the upper part of left arm for COVID-19 immunization. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1686, expiry Mar2021, on 07Jan2021, she had no reaction or anything. The patient had no medical history. The patient's concomitant medications were not reported. The patient was calling about the second shot, Pfizer asked if there were side effects on the second one, and there were, she can't say what went on yesterday, it was that bad. She was a volunteer at the hospital. She lost 3 pounds in the last few days from this. She was in no condition to talk to anyone yesterday, and in fact, she was getting hot now. Yesterday (26Jan2021) was the worst, she doesn't know how to describe, but her sheets were soaking wet, she kept having to urinate, and she's ashamed, she almost couldn't make it to the bathroom, her aide said to not be ashamed, and she had a lot of diarrhea. It was around 2am she noted her sheets were soaking wet, and it started going away at 5AM. She was still having effects from the shot: she was still getting very hot and cold. Getting very hot and cold started 12:00PM Monday (25Jan2021) night. Getting hot and cold was like the chills. She has 27 chronic illnesses but doesn't think they have anything to do with the shot. She was grateful she got the shot and hopes everyone at Pfizer was able to get the shot. The outcome of the event 'sheets were soaking wet, she kept having to urinate' was recovered on 27Jan2021, diarrhea and getting very hot and cold was recovering, lost 3 pounds and chills was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/25/2021,18.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Diarrhoea', 'Feeling of body temperature change', 'Pollakiuria', 'Urinary incontinence', 'Weight decreased']",2,PFIZER\BIONTECH, 1062144,OH,81.0,M,"Patient says that he has dermatitis; Rash; This is a spontaneous report from a contactable pharmacist and physician (patient himself). An 81-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: EL9261, exp date: May2021), via an unspecified route of administration on the left arm on 22Jan2021 15:30 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications reported as none. The pharmacist was calling to report that her father who had the Pfizer COVID-19 vaccine has a rash, a lot of a rash, after his first dose on 22Jan2021. No treatment was done for the rash. The pharmacist stated that her father though that the rash was a virus reaction. Patient (father) abruptly takes over the phone call and confirmed that he was the patient. Patient stated that he has dermatitis (this was a virus reaction) on upper and lower limbs for two days after the injection of vaccine (at night for 3 hours every night). The patient stated it was a virus reaction and he was dermatologist, a dermatology specialist, he has been for 50 yearrs experience. Patient stated it was a slight reaction, 2-3 hours of rash and physical reaction. Outcome of the events were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/22/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dermatitis', 'Rash']",1,PFIZER\BIONTECH, 1062145,,,F,"Arm was sore for 24 hours; This is a spontaneous report from a contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced that her arm was sore for 24 hours on Jan2021 with outcome of recovered on Jan2021. No follow-up attempts are possible; information on lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/01/2021,,UNK,,,,,,['Pain in extremity'],UNK,PFIZER\BIONTECH, 1062146,VA,75.0,F,"hurting in her chest, like she has to keep breathing; feeling kind of weird/ feeling bad; feeling kind of weird, off balance; Upset stomach; Chills; She cannot function very good, She is feeling so bad and cannot do nothing; At night time it is hard to try to do something and she cannot do it because she is tired; can hardly breathe at night; it kind of feels like she has an ear ache but she does not have an earache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via intramuscular route of administration on 14Jan2021 (at the age of 75-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) from an unknown date (per patient diagnosed quite a while ago and she goes to a pulmonary doctor). Concomitant medications included unspecified inhaler at two puffs per day if needed and unspecified recue inhaler one puff a day as needed, both ongoing for one year for COPD. The patient did not receive any other vaccines within four weeks prior to the vaccination or any other prior vaccinations or any vaccinations on the same date of the vaccination. The patient experienced chest pain, feeling abnormal, feeling off balance, upset stomach, chills, cannot function very good, tired, can hardly breathe at night and ear discomfort, all in Jan2021. The patient reported she received the vaccination on 14Jan2021 by her primary doctor. She is feeling kind of weird and has an upset stomach. She is asking how long this will last. She is worried about taking the second dose. She is supposed to have the second dose on 04Feb2021. She cannot function very good, states it kind of feels like she has an ear ache but she does not have an earache. Her balance is off and she can hardly breathe at night. All her symptoms started on the third day after getting the shot (Jan2021). She reports the feeling weird and off balance feeling feel like you are drunk. It aggravates her because she cannot function right. She also experienced chills started the third day after the shot and the chills have recovered completely. The patient reported that she was alright the first day. She has hurting in her chest, like she has to keep breathing which also started the third day after getting the shot and has been going on all this time. At night time it is hard to try to do something and she cannot do it because she is tired, states it is the worst part, She is feeling so bad and cannot do nothing. She has a hard time breathing. The events did not require a visit to emergency room or physician office. The patient did not have any relevant tests. The clinical outcomes of the events chest pain, feeling abnormal, feeling off balance, upset stomach were not recovered. The patient recovered from the chills in Jan2021. The outcome of the cannot function very good, she is feeling so bad and cannot do nothing, tired, can hardly breathe at night and ear discomfort was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/01/2021,,PVT,,COPD (diagnosed quite a while ago and she goes to a pulmonary doctor),,,,"['Abdominal discomfort', 'Balance disorder', 'Body height', 'Chest pain', 'Chills', 'Dyspnoea', 'Ear discomfort', 'Fatigue', 'Feeling abnormal', 'Loss of personal independence in daily activities']",1,PFIZER\BIONTECH,OT 1062147,TX,63.0,M,"Leg pain and bruising; Leg pain and bruising/bruising above both kneecaps and down his legs; Muscle aches; Feet are a little colder than normal; he still aches; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the right arm on 13Jan2021 09:00 at single dose for COVID-19 immunization. Medical history included taking blood pressure medicine, medicine for uric acid, stated he takes three medications but did not provide product names. The patient had the first COVID shot on 23Dec2020 at 20:30 at the right arm at the age of 63-year-old and clarified he had no problems after first vaccination. The patient experienced leg pain and bruising which started immediately day after second COVID shot on 14Jan2021. Noticed bruising above both kneecaps and down his legs, which felt like pretty severe flu pain. After a period of time, it didn't' feel right. He didn't see anything like that listed as side effects. Has gotten a little better but was still there. Takes Ibuprofen and it helps a little with the leg pain and bruising. Feet are a little colder than normal and he still aches, also had muscle aches on 14Jan2021 which he never had before. The outcome of the event leg pain and bruising was recovering and unknown for the rest of the events. Information on lot number/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/14/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure abnormal; Uric acid abnormal,,,"['Contusion', 'Myalgia', 'Pain', 'Pain in extremity', 'Peripheral coldness']",2,PFIZER\BIONTECH, 1062148,,,F,"had a 103 degree fever; nausea; myalgia; This is a spontaneous report from a contactable other hcp (patient). This report was received via a Pfizer sales representative. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration on 21Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had 1st dose of covid-19 vaccine on unspecified date. Caller stated that she got a call from a Nurse Practitioner (patient) who gets samples from her, and the patient informed the caller that she got the second dose of the COVID vaccine, and she informed about side effect she experienced. Caller stated that the patient seemed fine with consent for follow up from Pfizer, however, the caller wishes to only provide the reporter's (patient's) email address at this time. Caller confirms that the reporter is also the patient and does not know the reporter's date of birth, age, height, weight, or ethnicity. Caller confirmed the patient had the experience in the United States. Caller does not have prescriber information for the person who prescribed the product to the patient. It was reported that patient got the second dose of the COVID vaccine on Thursday 21Jan2021, and after that, she had a 103 degree fever, nausea, and myalgia. She reported that symptoms started 12 hours after receiving the second shot, and they lasted for about 24 hours. Caller does not know if the patient received any other vaccines on the same day as the COVID vaccine. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,,,UNK,,,,,,"['Body temperature', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH, 1062149,MA,63.0,F,"sore left arm/hip pain is radiating down to her leg; Knee pain; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), intramuscular in left arm near shoulder on 25Jan2021 10:20 at a single dose for COVID-19 immunization/prevent covid. Medical history included ongoing arthritis diagnosed years ago, ongoing arthralgia, has two titanium knees and she had the hip pain prior to the COVID injection but now her hip pain is radiating down to her leg. Concomitant medications included celecoxib (CELEBREX) from an unknown date and ongoing at 100mg capsule once a day by mouth for arthritis. The patient previously received the first dose of BNT162B2 (Lot: EK9231) administered on 05Jan2021 around 13:00, intramuscular injection in left arm near shoulder for COVID-19 immunization, SHINGRIX two shot dose, she had one in Dec2018 and the second one in Mar2019, stated that it hurt to where she could not even lift the arm. It was reported that on 25Jan2021, patient had the second dose of the vaccine and she had the typical sore arm 6 hours later that lasted 24 hours. She clarifies it recovered completely 48 hours later and she does not have the soreness as of today, states it does not bother her. Reports she also has it to where her knees and hip are hurting her. She has two titanium knees and she had the hip pain prior to the covid injection, but now her hip pain is radiating down to her leg. She has arthritis and with weather changes she experiences the hip pain. Her daughter told her it is a side effect of the shot. She is asking why this hip pain is radiating down. The knee and hip pain started around 9pm on 25Jan2021. Reports it is a tad better but it is painful. She does not have a fever. Treatment for the events knee pain included putting ice and heat on her knee and hip. The outcome of sore left arm/hip pain is radiating down to her leg was recovered on 27Jan2021, knee pain was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,PVT,CELEBREX,Arthritis (Verbatim: Arthritis diagnosed years ago); Knee replacement; Pain in hip (she had the hip pain prior to the covid injection),,,,"['Arthralgia', 'Pain in extremity']",2,PFIZER\BIONTECH,OT 1062150,MO,61.0,F,"Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if she pressed where the injection was it is still a little sore; She called in sick last week; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiration date not provided), via an unspecified route of administration in the right arm on 19Jan2021 13:30 at a single dose for COVID-19 vaccination. Medical history included Blood pressure high diagnosed a couple years ago. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) for COVID-19 immunization on 29Dec2020 and unspecified flu shot last fall, she thinks in Sep or Oct2020, but she has never had problems with those. Concomitant medications included unspecified medications. The patient called and said she had reaction to the Pfizer COVID-19 vaccine 12 hours after her second dose and wanted to report it. She said also this past weekend, on Sunday, on 24Jan2021, she started to develop a localized rash that has like a border to it. She added that she got her second dose of the COVID-19 vaccine on 19Jan2021 at about 01:30 PM in her right arm. She said that she woke up the next morning, 20Jan2021 at 03:00 AM with a high fever, nausea, vomiting, dizziness, and rapid heart rate. She said that the high fever that started the temperature she took was 103 initially, she says she took paracetamol (TYLENOL) and it came down to 101, and the next day it was probably 100 most of the day, then it broke that evening. She said the Tylenol, the dose was the extra strength, unknown if it was 500 mg, they were capsules. She says she normally doesn't keep it around, the in-house nurse suggested it so she went and got a sample thing and took a couple doses, she doesn't have it with her as she is at work and is not at home. She said that the nausea and vomiting subsided after the first day or second day, she had the on and off fever and slept most of the day both days. She said that she doesn't have a fever now. She said that she doesn't have her exact heart rate from when she was having the rapid heart rate, she just felt it in her chest. She added that the only reason she said anything was because she called in sick last week on an unspecified date in Jan2021. She said that the rash started developing after that and it is now probably the size of a 16 oz or 60 oz cup, unable to clarify number with caller, she said that it is definitely big but it doesn't bother her, though she is concerned it is there. She clarified that it is a couple inches in diameter and kind of looks like the state of (State Name), on her injection arm which was her right arm. She said her arm is not sore now, it was after the shot on an unspecified date in Jan2021, if she pressed where the injection was it is still a little sore. She said that the hospital said to report it. She said she also has a concern if she should she get another shot if they decide this is needed for more than two vaccinations. She said that she knows they are still gathering information at this point, so she thought she should better turn in, hopefully there will be solution later on. The outcome of the events localized rash, dizziness, heart rate increased and sickness was unknown. The outcome of the events fever, nausea and vomiting was recovered on an unspecified date in Jan2021 while the outcome of the event vaccination site pain is recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/01/2021,,PVT,,,Medical History/Concurrent Conditions: Blood pressure high (diagnosed a couple years ago),,,"['Body temperature', 'Dizziness', 'Heart rate', 'Heart rate increased', 'Illness', 'Nausea', 'Pyrexia', 'Rash', 'Vaccination site pain', 'Vomiting']",2,PFIZER\BIONTECH, 1062151,OH,66.0,F,"Running a fever of 100.3; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) in Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient was running a fever of 100.3 (unit was not reported). The outcome of the event, 'fever', was unknown. The patient would want to know if the fever was normal, and if she could take ibuprofen. Information regarding lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['Body temperature', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1062152,NJ,67.0,M,"Injection site pain; not sleeping; it still hurts, it is very sore by his bicep; sheer exhaustion; is very uncomfortable sitting; This is a spontaneous report from a contactable consumer reporting for himself. A 67-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1686, Expiry date: 31Mar2021), via an unspecified route of administration (arm left) on 18Jan2021, 12:00 (noon) at SINGLE DOSE for COVID-19 immunization, at 67 years old. Medical history included torn rotator cuffs from an unspecified date. The patient previously took Flu shot for immunization. Patient stated his last vaccination he had was the flu shot 6 months before on an unspecified date, that was a while back. Patient had pain in his left arm at the injection site. He is not sleeping because the pain is waking him up. It has been more than a week at 10 days, and it still hurts. It is very sore by his bicep. Events occurred on 19Jan2021, reported as started hurting the next day maybe, it was not immediately after. He says since then he has had pain, and in the past, he has had torn rotator cuffs, and those hurt, but he was not sleeping due to this pain now, he fell asleep at 06:00AM this morning from sheer exhaustion (Jan2021). He says he is very uncomfortable sitting, he can't lay on that side, and he can't get comfortable. He was taking MOTRIN 800 mg as needed, and he put ASPERCREME on it. He says that his MOTRIN was prescribed by a doctor, it was the only thing working for the pain for this. He says he also tried Naproxen, then says it's Aleve actually, he has only taken this once. It was 220 mg, he took one by mouth, one time. He applied the ASPERCREME to the injection site about three times last week, he says he was experimenting here, he does not know. He says he tried ice which helped a little bit, ice always helps, but when it wears out it comes back. He stated he feels the pain walking, when he is putting his shirt on, sitting in his recliner, it is constant. His vaccine card is handwritten, there is no NDC written on there. It has no information about the syringe that was used, NDC/LOT/EXP information were unknown, they didn't put it down or the information on the card for his wallet. Patient stated he saw a doctor but not for the injection site pain. He stated if it was just initial pain, he wouldn't be asking but it has been 10 days now, he thought it would be gone by now, he tried to see how long it could last on the paper they gave and called the number from the paper. He says he had no swelling, it was just really sore, he would like to know if this is normal, if so, he can hang on and tough it out. Treatment was given in response to the events. Outcome of the events Injection site pain, not sleeping, it still hurts, it is very sore by his bicep was not recovered. Outcome of the events sheer exhaustion and is very uncomfortable sitting was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Rotator cuff tear,,,"['Discomfort', 'Fatigue', 'Insomnia', 'Myalgia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1062153,,71.0,F,"I got a big side effect dizzy and I was almost falling; dizziness; Headache; Nauseous; Feel pinch in my stomach; Lot of pain in my whole body; Chills especially at night; Tinnitus; I can't hear you very well because it's so bad. I have a lot of noise in my ear and I can't listen you very well. I couldn't hear; Little side effect of the vaccine, but it continued till now and I feel so sick now; scared because she was falling; scared because she was falling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: unknown), via an unspecified route of administration on 21Jan2021 (also reported as on Wednesday) at SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure high and diabetes. Concomitant medication included glimepiride (GLIMEPIRIDE) for diabetes and olmesartan (OLMESARTAN) for blood pressure high. It was reported that the patient was experiencing for over a week a lot of side effect of the vaccines. She was scared because she got dizzy which she was almost falling (also reported as scared because she was falling) in Jan2021. The patient also had headaches (a lot of headaches) and every day she had to take pills. She also felt like nauseous and pinch in her stomach. She had a lot of pain in her whole body and have chills especially at night after she had the COVID-19 Vaccine. The patient also had got a lot of tinnitus (lot of noise in her ear and can't listen very well) she can't hear very well because it's so bad. She also felt so sick now that she doesn't feel like doing nothing just to be in bed. The patient events were not recovered (continued till now). Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/01/2021,,UNK,GLIMEPIRIDE; OLMESARTAN,,Medical History/Concurrent Conditions: Blood pressure high; Diabetes,,,"['Abdominal discomfort', 'Chills', 'Dizziness', 'Fall', 'Fear', 'Headache', 'Malaise', 'Nausea', 'Pain', 'Tinnitus']",UNK,PFIZER\BIONTECH, 1062154,FL,60.0,F,"swelling at the site; redness at the site; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: EU9899), via an unspecified route of administration in the left arm on 30Dec2020 at 15:00 as a single dose for COVID-19 immunisation. Medical history included anemia, diabetes mellitus, blood cholesterol abnormal, blood pressure abnormal, and low FE. The patient had no additional vaccine/s administered on the same date as BNT162B2, had no prior vaccinations within four weeks, and had no family medical history. Concomitant medications included liraglutide (VICTOZA; taking for 8 years), labetalol (taking for 20 years), diltiazem (CD taking 20 years), valsartan (DIOVAN; taking for 20 years), rosuvastatin (taking for 10 years), metformin (taking for 20 years), aspirin [acetylsalicylic acid] (taking for 10 years), and iron; all are ongoing. On 30Dec2020, the patient experienced swelling at the site and redness at the site. The patient stated that after the first dose, she noticed a little bit of swelling and redness at the site that went away in 48 hours. She had no relevant tests done. The events did not require any visit to a physician or to the ER. Outcome of the events was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,PVT,VICTOZA; LABETALOL; DILTIAZEM; DIOVAN; ROSUVASTATIN; METFORMIN; ASPIRIN [ACETYLSALICYLIC ACID]; IRON,,Medical History/Concurrent Conditions: Anemia (From 2 months); Blood cholesterol abnormal; Blood pressure abnormal; Diabetes; Iron low,,,"['Vaccination site erythema', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 1062155,NJ,,F,"Headache; pain in her arm at the injection site; Quivering in chest; Sleepy; Lightheadedness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 2nd of two reports. A female patient of an unspecified age received BNT162B2 (Lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, pain in her arm at the injection site, quivering in chest and sleepy on an unspecified date. On 23Jan2021, the patient experienced lightheadedness. Lightheadedness was reported as worsened. The outcome of the event ""lightheadedness"" was not recovered. The outcome of the other events was unknown. Information about Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021117202 same reporter/drug, similar events, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,01/23/2021,,UNK,,,,,,"['Chest discomfort', 'Dizziness', 'Headache', 'Somnolence', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 1062156,FL,69.0,F,"broke out with some red rashes on chest and on face, on the bottom of face/it has behind my ear that was the rashed I have; I got a lump on the back of my ear and it is only on the left side where I took the injection; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL8982, expiry date: unknown), via an unspecified route of administration, on 24Jan2021, at single dose, for covid-19 immunization. Medical history included diabetes mellitus and urinary tract infection (UTI). Concomitant medication included amlodipine; ciprofloxacin; losartan; metformin; metoprolol; insulin human, insulin human injection, isophane (NOVOLIN 30/70); insulin human, insulin human injection, isophane (NOVOLIN 70/30); rosuvastatin and unspecified antibiotics that was taken from 11Jan2021 to 15Jan2021 for UTI. On 24Jan2021, on the same day of vaccination, the patient broke out with some red rashes on chest and on face, on the bottom of face and got a lump on the back of ear and it was only on the left side were she took the injection. The patient stated, ""it's just on my chest, it's just red rashes on my chest and it has behind my ear that was the rashes I have. But it is on the left side only, it is not all over."" The patient was wondering if it was normal to break out like that as it occurred on the same day she received the vaccine and asked what she should do. The date of the second dose was reported to be on 14Feb2021. No treatment was given for the events. The patient reported she does her blood sugar twice a day (unknown results). The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/24/2021,01/24/2021,0.0,UNK,AMLODIPINE; CIPROFLOXACIN; LOSARTAN; METFORMIN; METOPROLOL; NOVOLIN 30/70; NOVOLIN 70/30; ROSUVASTATIN,,Medical History/Concurrent Conditions: Diabetes; UTI,,,"['Blood glucose', 'Mass', 'Rash erythematous']",1,PFIZER\BIONTECH, 1062157,,,U,"My shoulder, my arm is really hurting; My shoulder, my arm is really hurting; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had the Pfizer vaccine yesterday, and reported that ""my shoulder, my arm is really hurting."" The outcome of the events was unknown. No follow-up attempts are possible. Information on Lot/ Batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Arthralgia', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 1062158,,,U,"Shingles; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is going to have an appointment for the second shot of COVID-19 vaccine on 07Feb2021. Now in the meantime, the patient come down with shingles on unspecified date and was wondering if the patient can make the appointment to have the second shot. Outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Herpes zoster'],1,PFIZER\BIONTECH, 1062159,TN,83.0,M,"slight pain in his arm the shot was given; if he moved his arm, he would have slight discomfort; some slight tenderness in his shoulder; Yesterday, his temperature was 97 something. This morning, he got up at 6am and his temperature was around 98.8; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261; expiry date: unknown) via an unspecified route of administration in the left arm, on 26Jan2021 at 8:30 to 9 AM, at a single dose, for Covid-19 immunization. Medical history in Mar2020 included had a temperature for 7 days. He tested positive for COVID and it took a while to test negative. At the end of Mar2020 until the first of Apr2020, his temperature was 97 something. He has checked his temperature every day since then. There were no concomitant medications. The patient had no previous immunization with the Pfizer vaccine. He did not receive additional vaccines on the same date bnt162b2 was given. The patient had his first COVID-19 shot yesterday morning about 8:30 or 9:00. He hadn't really looked at the list of side effects, but yesterday afternoon (26Jan2021), he had slight pain in the arm where the shot was given. If he moved his arm, he would have slight discomfort. The pain was mostly gone today. He also had some slight tenderness in his shoulder, but it's certainly less than what it was yesterday. He saw other things that were listed including fever. He wanted to know if Pfizer had any information as what to amount of fever people typically experience after having the shot. Yesterday (unspecified date in Jan2021), his temperature was 97 something. This morning, he got up at 6 am and his temperature was around 98.8. And then he had to take his wife to therapy and when he got back 3 hours later, he took it now and his temperature was 99 degrees. He was just wondering if Pfizer had an idea of how much fever is normal from the shot? He hasn't had any other reactions. The events did not require Emergency Room or Physician's Office visit. The patient underwent lab tests and procedures which included body temperature: 97 something on 26Jan2021, 98.8 and 99 on 27Jan2021; sars-cov-2 test: positive on an unspecified date in 2020 and negative on an unspecified date in 2020. Outcome of the event ""slight pain in his arm the shot was given"" was recovering, while for the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/01/2021,,PVT,,,Medical History/Concurrent Conditions: COVID-19 (He tested positive for COVID and it took a while to test negative); Fever (he had a temperature for 7 days),,,"['Arthralgia', 'Body temperature', 'Body temperature increased', 'Limb discomfort', 'SARS-CoV-2 test', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1062160,MI,79.0,M,"Cold chills; Fever; Not feeling well; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) on his left arm, intramuscular on 19Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he had Cold chills, fever and not feeling too well. He took one Tylenol for fever. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,01/01/2021,,UNK,,,,,,"['Chills', 'Malaise', 'Pyrexia']",UNK,PFIZER\BIONTECH,OT 1062161,MI,72.0,F,"Too long to have muscle pain from a shot; Migraine headache; severe arm pain where the shot was injected; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261; expiration date not provided), via an unspecified route of administration from 21Jan2021 to 21Jan2021 at SINGLE DOSE for an unspecified indication. Medical history included 'thyroid' from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine from an unspecified date and unknown if ongoing at 100 ug, 1x/day for 'thyroid'. Patient stated that she spoke with her physician's assistant. Patient received vaccine on the 21st of January, the first shot at her local place. The following morning at 4 in the morning, patient had severe arm pain where the shot was injected. So patient put a hot compress on it and took some paracetamol (TYLENOL). Patient mentioned that it didn't relieve for about an hour and a half. Patient meant the pain was really severe but finally it went away. The next day, it came back again and then the patient did it again and the pain keep coming back. Patient stated ""And now it's been tomorrow will be a week. And that's too long to have muscle pain from my shot"". Patient also mentioned that second day after the shot, migraine headache started. Patient stated, ""Now I get them, but I only get them in the spring and I get them in the Fall. I don't get the migraine headaches in the winter time. I could only take Excedrin Migraine for the migraine, it's just over the counter medicine. And so I took that for the headache but those have not gone away either. When patient contacted her physician's assistant just now, it was reported that patient the physician's assistant is going to write a prescription for a muscle relaxer. Patient also reported that she is not going to take that second shot as she didn't know where to go to cancel it but she is not taking it. Patient mentioned she can't have pains like this. Patient stated that she can't tolerate pain to begin with, let alone have excess pain in her system. Patient added that she doesn't take medications. She is only on a thyroid medication (later confirmed the name as levothyroxine). Patient confirmed that the vaccine was Pfizer COVID-19 vaccine. When probed for the due date of the next shot, patient stated 'February 11th at 12 o' clock'. Patient also stated 'I am not getting it, I am not taking the second shot. I didn't get you, I don't know what you said. I am not understanding you. I am not getting what you are saying. I am not taking the second shot, it is scheduled for February 11th of 2021, I am not taking it. Because they called and asked if I wanted to receive it and my age is almost 73. So, I thought I probably should give it a chance. But now with the reaction I don't want the second one' and 'I don't know if there is something wrong with this phone or something wrong with the connection, I don't understand, I get part of it but I don't understand the other part. It blanks out, I don't know what's wrong, you are asking me something, but I don't know what it is'. Patient also reported that the pain started the day after she got the shot, 22Jan2021. Patient is still having pain. Patient also confirmed that TYLENOL was the treatment for pain but it was not working. Medication for migraine was reported as EXCEDRIN migraine. Patient further confirmed EXCEDRIN Migraine did not help with the migraine and stated 'No, I still have it, it gives me some relief but then after wears off it comes back, the migraine comes back'. Patient further added ""Okay, I am just going to rely on my physician assistant, she has got some medication ordered for me, a muscle relaxer. And I am going to try that and see if that will make everything go away"". Outcome of the events 'severe arm pain where the shot was injected' and 'migraine headache' was not recovered; outcome of the remaining event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/22/2021,1.0,UNK,LEVOTHYROXINE,,Medical History/Concurrent Conditions: Thyroid disorder,,,"['Migraine', 'Myalgia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1062162,FL,77.0,M,"where he broke the skin with a nail that was a little rusty; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first single dose of BNT162B2 (Solution for injection, lot number: GL3249, exp date not reported) , intramuscular on 09Jan2021 12:00 for COVID-19 immunization; and tetanus vaccine, intramuscular (anatomical location: right arm) on 25Jan2021 at unspecified dose/frequency as tetanus shot. Patient received his first COVID shot at a Hospital. Patient had no relevant medical history. There were no concomitant medications. The patient was due for his second shot this Saturday, 30Jan2021. Patient went to a physician's office to receive a tetanus shot on Monday, 25Jan2021. On the same date (25Jan2021), he had a little incident where he broke the skin with a nail that was a little rusty. He was wondering if that was an inhibitor to the vaccine. Patient wanted to know and or have a heads up if getting the Tetanus shot will cause him to have to reschedule his second COVID-19 vaccine. No Emergency Room visit required for the events. No relevant test/s performed. The outcome of events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/25/2021,16.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['Skin disorder'],1,PFIZER\BIONTECH,OT 1062163,FL,65.0,F,"started developing a rash. Like red patches on her arms/showed up on her stomach, chest and thighs. They flare-up.; It's a little bit itchy; This is a spontaneous report from a contactable consumer (patient) reported that a 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EC8982), via an unspecified route of administration on 21Jan2021 at a single dose for Covid-19 immunization. Medical history included blood pressure high, thyroid disorder (reported as thyroid), and cholesterol high. Concomitant medications included lisinopril and hydrochlorothiazide both for blood pressure high, levothyroxine, and atorvastatin for cholesterol high; all were taken from an unspecified date. On 26Jan2021 afternoon, the patient started developing a rash. Like red patches on her arms, she put the Cortisone on her arms and it went away. But then it showed up on her stomach and chest and thighs. They flare-up. It's a little bit itchy. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/26/2021,5.0,UNK,LISINOPRIL; HYDROCHLOROTHIAZIDE; LEVOTHYROXINE; ATORVASTATIN,,Medical History/Concurrent Conditions: Blood pressure high (Verbatim: Blood pressure high); Cholesterol high (Verbatim: Cholesterol high); Thyroid disorder (Verbatim: Thyroid),,,"['Rash erythematous', 'Rash pruritic']",1,PFIZER\BIONTECH, 1062164,IN,49.0,F,"dull achiness on the right side of temple area/headaches; head was sensitive; really bad migraine; turn off the lights in the office/has to have the lights low, still sensitive; arm hurt worse with second dose; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EK9231, expiry date Apr2021), via an unspecified route of administration on 19Jan2021 at a single dose, administered left arm at 4:10-4:15pm, as a coworker came down with Covid (COVID-19 immunization). The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm hurt with first dose of bnt162b2 given intramuscularly in the left arm (Lot number EL1284) on 29Dec2020 for COVID-19 immunization. Patient had her second Covid vaccine last Tuesday, 19Jan2021. She had a really bad migraine Friday, 22Jan2021 and had to turn off the lights in the office. On Saturday, 23Jan2021, her head was sensitive, but on Sunday, 24Jan2021, later in the evening she had this dull achiness on the right side of temple area that went down behind the right eye down to the temple. The dull and achiness was just enough to where she couldn't function and been like that ever since. She was prone to headaches and migraines, this was just different and so she took Tylenol and Aleve (both with believed dose was 200mg, 2 tablets by mouth since Jan2021), and another medication for migraines, Ubrelvy (lot number: 1084537, expiry Jan2022, dosage text: 100mg, 1 by mouth at first sign of headache, started in Jan2021). She took the Tylenol and it maybe of help, but the migraines/headaches are almost constant all day long. She took the Tylenol early Friday and when the migraine got really bad that was when she took the Ubrevly. She took the Aleve only yesterday, but she still has to have the lights low, still sensitive. Patient knew that the headaches are a sign of Covid, but when she had her first dose her arm hurt. This second arm hurt worse, arm hurt worse with second dose (Jan2021), and she did fine the first few days and Friday was when all of a sudden she had the migraine and had to turn off the lights in the office. She sits at a computer. The events did not require emergency room or physician office visits. Therapeutic measures were taken as a result of really bad migraine, ""turn off the lights in the office/has to have the lights low, still sensitive"", and ""dull achiness on the right side of temple area/headaches"". The patient had not recovered from really bad migraine, head was sensitive, and ""dull achiness on the right side of temple area/headaches"". The outcome of the events ""turn off the lights in the office/has to have the lights low, still sensitive"" and arm hurt worse with second dose was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/01/2021,,PVT,,,,,,"['Head discomfort', 'Headache', 'Migraine', 'Pain in extremity', 'Photosensitivity reaction']",2,PFIZER\BIONTECH, 1062165,NJ,74.0,F,"rapid heart beat; headache; pain in her arm at the injection site; quivering in chest and palpitations; quivering in chest and palpitations; lightheadedness; tired; anxious; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 1st of two reports. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: May2021), via an unspecified route of administration on 22Jan2021 at 15:30 at a single dose on left arm for COVID-19 immunisation. Medical history included triglycerides high, obesity, blood clotting issues, thyroid disorder and blood cholesterol abnormal from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, rosuvastatin calcium, aspirin (acetylsalicylic acid) and vitamin D3. The patient experienced rapid heartbeat, headache, quivering in chest and palpitations, lightheadedness, pain in her arm at the injection site, tired on 23Jan2021 and anxious on 22Jan2021. The patient stated that on Saturday (23Jan2021), she noticed pain in her arm at the injection site, a headache, and feeling of like she was quivering in her chest. She was also experiencing palpitations, lightheadedness, and periods of rapid heartbeat. On Monday, the symptoms were a little less but yesterday and today she has had a lot of palpitations, quivery feelings in her chest and rapid strong heart beats. On Saturday, she took an aspirin for headache. On Sunday, she had just a mild headache and by Monday (25Jan2021) it was gone. She wanted to know if these are normal reactions and if she should call the doctor, or what she should do about them. The patient underwent lab tests and procedures which included blood triglycerides: high and body mass index: high on Jan2021; heart rate: rapid on 23Jan2021. Therapeutic measures were taken as a result of headache. The outcome of the events pain in her arm at the injection site and headache was recovered on 25Jan2021, while of the rest was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021116966 same reporter/drug, similar events, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,PVT,LEVOTHYROXINE; ROSUVASTIN; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN D3,,Medical History/Concurrent Conditions: Blood cholesterol abnormal; Clotting disorder; Obesity (Verbatim: Obesity); Thyroid disorder; Triglycerides high (Verbatim: Triglycerides high),,,"['Anxiety', 'Blood triglycerides', 'Body mass index', 'Chest discomfort', 'Dizziness', 'Fatigue', 'Headache', 'Heart rate', 'Heart rate increased', 'Palpitations', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1062166,CA,,F,"Body ache; Chills; Headache; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales Representative. The consumer reported on three patients. This is the first of three reports. A female patient of an unspecified age received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, on the second dose of vaccination the patient experienced body ache, chills and headache. The patient was treated for body ache, chills and headache with ibuprofen and the symptoms went away in one day. The clinical outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021117324 same reporter/product/event, different patient;US-PFIZER INC-2021117244 same reporter/product/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Chills', 'Headache', 'Pain']",2,PFIZER\BIONTECH, 1062167,CA,,U,"Body ache; Chills; Headache; This is a spontaneous report from a contactable consumer via Pfizer sales Representative. The consumer reported on three patients. This is the second of three reports. A patient of an unspecified age and gender received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, on the second dose of vaccination the patient experienced body ache, chills and headache. The patient was treated for body ache, chills and headache with ibuprofen and the symptoms went away in one day. The clinical outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021117236 same reporter/product/event, different patient;US-PFIZER INC-2021117324 same reporter/product/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Chills', 'Headache', 'Pain']",2,PFIZER\BIONTECH, 1062168,NY,41.0,F,"when she woke up in the morning her gum on her right face was swollen; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 06Jan2021 at a single dose (at the age of 41-years-old) for COVID-19 immunization. Medical history included high blood pressure. Concomitant medication included amlodipine for high blood pressure. The patient took the COVID vaccine and worked at the hospital six days after the first dose, when she woke up in the morning her gum on her right face was swollen (12Jan2021) and she took the vaccine on left side. She figured it was something with her gum and it was not related. She went to the dentist and everything, and he (dentist) cleared that nothing was wrong with her gum. The patient did not receive treatment for the event. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event ""gum on her right face was swollen"" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/12/2021,6.0,UNK,AMLODIPINE,,Medical History/Concurrent Conditions: Blood pressure high,,,['Gingival swelling'],1,PFIZER\BIONTECH, 1062169,DC,67.0,F,"felt very sleepy; very tired; Headache; elevated temperature; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable consumer (patient herself) reported that a 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL1283, UPC/NDC number and expiration date were unknown), via an unspecified route of administration in the left deltoid (also reported as left shoulder) on 16Jan2021 at a single dose for COVID-19 immunization. Relevant medical history included hypertension, for which she was taking medication for it and had a torn redness on her rotator cuff; from an unknown date and unknown if ongoing. Concomitant medications included cortisone injection as she had a torn redness on her rotator cuff, as she guessed and she was taking an unspecified medication for hypertension. The patient just wanted to report that after taking the vaccine (Covid-19 Vaccine) on the 16Jan2021, she felt very sleepy and then very tired, slightly headache and she had elevated temperature. The patient further stated that she had elevated temperature and lastly, after she had the injection, she got really, really sleepy. The patient stated that before she had the injection, she had a cortisone injection, so she didn't know. The events did not require any visit to the physician office or to the emergency room. Therapeutic measures were taken as a result of felt very sleepy, very tired, headache, and elevated temperature, which included paracetamol (TYLENOL). The outcome of all the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,01/16/2021,0.0,UNK,CORTISONE,,Medical History/Concurrent Conditions: Hypertension (taking medication for hypertension); Rotator cuff tear,,,"['Body temperature', 'Body temperature increased', 'Fatigue', 'Headache', 'Somnolence']",UNK,PFIZER\BIONTECH, 1062170,CA,,U,"Body ache; Chills; Headache; This is a spontaneous report from a contactable consumer via Pfizer sales Representative. The consumer reported on three patients. This is the third of three reports. A patient of an unspecified age and gender received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, on the second dose of vaccination the patient experienced body ache, chills and headache. The patient was treated for body ache, chills and headache with ibuprofen and the symptoms went away in one day. The clinical outcome of the events was recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021117236 same reporter/product/event, different patient;US-PFIZER INC-2021117244 same reporter/product/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Chills', 'Headache', 'Pain']",2,PFIZER\BIONTECH, 1062171,IN,49.0,F,"arm hurt with first dose; This is a spontaneous report from a contactable consumer (patient herself). A 49-year-old female patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via intramuscular route of administration in the left arm on 29Dec2020 at a single dose because ""a coworker came down with Covid."" Medical history included migraine and headache. The patient's concomitant medications were not reported. The patient had no additional vaccines administered on same date of the Pfizer suspect. The patient reported that her arm hurt with first dose on an unspecified date. There were no relevant tests conducted. The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,,,PVT,,,Medical History/Concurrent Conditions: Headache; Migraine,,,['Vaccination site pain'],1,PFIZER\BIONTECH,OT 1062172,TX,60.0,F,"started to feel dizzy after getting the first dose of the COVID-19 Vaccine today; just checked her blood sugar, and her blood sugar was high at 146.; This is a spontaneous report from a contactable consumer (patient's daughter). A 60-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the right arm on 28Jan2021at 09:30 (at the age of 60-years-old) as a SINGLE DOSE for covid-19 immunisation . Medical history included breast cancer female from 17Feb2019 (taking medicine for the breast cancer for 2 years), Cardiac disorder from an unknown date (problems with her heart about 2 weeks ago, and had to have her heart examined), and Prediabetes Concomitant medication(s) include takes medication for breast cancer and prediabetes. No other vaccines were given within 4 weeks No Additional Vaccines were administered on Same Date of the Pfizer Suspect. On 28Jan2021, The patient experienced started to feel dizzy after getting the first dose of the COVID-19 Vaccine today and just checked her blood sugar, and her blood sugar was high at 146. No Physician office visit and No Emergency room visit required due to the events. Reporter stated her mother is feeling better now. Patient checked her blood pressure and it was 127/72. The patient underwent lab tests and procedures which included blood glucose: High 146 on 28Jan2021; blood pressure measurement: 127/72 on 28Jan2021, cardiac stress test: unknown results on an unknown date, heart resistance test: unknown result on an unknown date. Caller asked what Pfizer recommends for the dizziness. The clinical outcome of the event dizzy was recovering which blood glucose high was unknown Information on the lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,UNK,,,"Medical History/Concurrent Conditions: Breast cancer female (taking medicine for the breast cancer for 2 years.); Heart disorder (problems with her heart about 2 weeks ago, and had to have her heart looked at.); Prediabetes (takes medicine for prediabetes)",,,"['Blood glucose', 'Blood glucose increased', 'Blood pressure measurement', 'Cardiac stress test', 'Dizziness', 'Investigation']",1,PFIZER\BIONTECH, 1062173,NC,,U,"Soreness/at injection site; Overwhelming fatigue/Tiredness; Headache; pain a lot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis, and chronic fatigue, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had the first Pfizer vaccine (unspecified vaccine) on 23Jan2021 and since then had expected some soreness which patient had at the injection site on an unspecified date in 2021. And they even on that might be tiredness. Well patient already have chronic fatigue so patient know about tiredness. Patient did remember the headache (2021) were also which already have with chronic fatigue which patient have. Now chronic fatigue likes very tired but normal not act tired as with this vaccine. This morning patient tried to get in card to go to the grocery store to get some groceries and have to comeback that how tired and fatigue that was. Now patient just wondered ""the fatigue it was a very ""pain a lot"" (not clarified) byproduct of this vaccine. It must be (incomplete sentence)."" The ""things"" (not clarified) patient was concerned was, patient heard on the news that the second vaccine would be rougher or have more side effects than the first and that's the reason patient called and the second vaccine which patient was due to have on February 13th would have more side effects than this first one. With the first one expected this overwhelming fatigue. It has been relatively now. Headache, soreness on the injection site but patient thought the tiredness would go away but it has not. Now patient questioned if the second vaccine will that be Pfizer also. The patient had not recovered from the event fatigue. The outcome of the other events was unknown. Information on lot/batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,,,UNK,,,Medical History/Concurrent Conditions: Chronic fatigue; Rheumatoid arthritis,,,"['Fatigue', 'Headache', 'Pain', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1062174,AZ,33.0,F,"she threw up; diarrhea; body pain; She had chills; Slight headache; Feeling hot; feverish; This is a spontaneous report from a contactable consumer (patient's father) and a non-contactable consumer (patient). A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 26Jan2021 as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and dizziness from an unknown date and unknown if ongoing, Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), diazepam (MANUFACTURER UNKNOWN) for dizziness, ethinylestradiol, norethisterone (DASETTA 1/35) for birth control and multivitamins, all from an unknown date. The patient previously received first dose BNT162B2 (lot number EH9899) on 05Jan2021. On 26Jan2021 (about 10 in night) the patient experienced she threw up, diarrhea, body pain, and chills, she experienced slight headache, feeling hot and feverish on 26Jan2021. The patient did not receive any treatment for the events. The clinical outcome of the events vomiting, diarrhea, body pain, chills, headache, feeling hot and fever was recovering (reported as getting a little better now).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,UNK,AMITRIPTYLINE; DIAZEPAM; DASETTA 1/35,,Medical History/Concurrent Conditions: Dizziness; Fibromyalgia,,,"['Chills', 'Diarrhoea', 'Feeling hot', 'Headache', 'Pain', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH, 1062175,OH,50.0,F,"her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high blood pressure; possible allergic reation; a cool, tingling sensation in her legs; a cool, tingling sensation in her legs; Heart rate increased; she numbness in her top lip; she had a tingling at the top of her head; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 and expiration date May2021, right arm on 25Jan2021 Administered between 16:00-16:15 PM as single dose (at the age of 50 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Retinitis pigmentosa from 2016, and breast cancer in Dec2015, she is in remission. Went through chemotherapy and reconstructive therapy. She has a family history of breast cancer. Additionally, patient has history of panic attack, supplementation therapy and eye disorder vitamin (she saw her eye doctor in Dec2020, and he recommended she start taking the eye vitamin. She said she started the eye vitamin in the end of Dec2020). The patient has historical vaccine information including flu vaccine Sep2020. Concomitant medication includes lysine;zinc (LYSINE;ZINC) as supplementation therapy from Dec2020 and ongoing, xantofyl, zeaxanthin, (LUTEIN-ZEAXANTHIN), as eye vitamin Dec2020, ascorbic acid (VIT C), acetylsalicylic acid (baby aspirin) and probiotics (PROBIOTICS). The patient experienced a cool, tingling sensation in her legs on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), heart rate increased on 25Jan2021 with outcome of recovered on 25Jan2021 (She said she thought maybe her rapid heart rate was from her nerves because she was getting her first COVID-19 Vaccine dose), she numbness in her top lip on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), she had a tingling at the top of her head on 25Jan2021 with outcome of recovered, her legs kind of felt like they do when her legs go to sleep on an unspecified date with outcome of unknown, anxiety on an unspecified date with outcome of unknown, heart palpitations on an unspecified date with outcome of unknown, high blood pressure on an unspecified date with outcome of recovered. She said the nurse suggested she talk to a medic located in the back are of where the COVID-19 Vaccines were being administered. She said she talked to medic. She said at that point it was probably about 25 minutes after she received the COVID-19 Vaccine. She said she never had allergies, and had no problem with the flu vaccine. She said she has had issues with anesthesia in the past, and if she is given the wrong type of anesthesia, she can get nauseous. She said the medic took her heart rate, and her heart rate was 154-ish. She said her heart rate was high, but sometimes for her, that is the case. She said the medic asked her how her breathing was. She said her breathing was OK, and could swallow fine. She said when the medic rechecked her heart rate, her heart rate was still the same. The medic said she has two things he can do: she can go to get Benadryl, or she can get checked out by a doctor. She said she wanted to see a doctor. She said she was brought to an Urgent Care to see a doctor. She said her heart rate was still elevated. She said the urgent care staff did a finger prick test (clarified as a blood sugar finger stick test), and she was told the finger prick test was fine. She said the doctor did an EKG, and her EKG was fine. She said the Urgent Care doctor eventually gave her Benadryl. She said after she took the Benadryl, her top lip was not numb, and her legs were fine. She said that was about 3 hours after receiving the COVID-19 Vaccine. She said the doctor felt she had a panic attack. She said she has had one panic attack in the past, and knows what a panic attack feels like. She said she maybe had some anxiety. She said her symptoms didn't seem like a panic attack because she wasn't having difficulty breathing and she wasn't short of breath, but she was somewhat nervous. She said she was not sure what to do, so she contacted her family doctor to see what she should do when she goes for her second COVID-19 Vaccine dose. She said the Urgent Care doctor gave her a prescription for Hydroxyzine Pamoate 25mg capsule, 1 capsule three times daily, as needed, for anxiety. She said her doctor told her the Hydroxyzine Pamoate is used for allergic reactions, as well. She clarified when she was at the urgent care her heart rate went down, and the nurse at the urgent care gave her 2 Benadryl pink capsules. Reported she took Benadryl when she got home because she was afraid she was having an allergic reaction to the COVID-19 Vaccine. Outcome of possible allergic reaction was unknown. She said she had a great night sleep, and the next morning took her first dose of the Hydroxyzine Pamoate 25mg. She said her primary care doctor suggested she take the Hydroxyzine Pamoate 25mg an hour before she gets the second COVID-19 Vaccine dose. The patient underwent lab tests and procedures which included blood sugar finger stick test: 117 on 25Jan2021, electrocardiogram: normal on 25Jan2021 said the doctor did an EKG, and her EKG was fine, heart rate: 154-ish on said her heart rate was high. She said her heart rate was still elevated. Therapeutic measures were taken as a result of a cool, tingling sensation in her legs, she numbness in her top lip, she had a tingling at the top of her head.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,PVT,LUTEIN-ZEAXANTHIN; VIT C; BABY ASPIRIN; PROBIOTICS; lysine; zinc,,Medical History/Concurrent Conditions: Breast cancer (Stated she is in remission. She said she went through chemotherapy and reconstructive therapy. She said she has a family history of breast cancer); Breast reconstruction; Chemotherapy; Eye disorder prophylaxis; Panic attack; Retinitis pigmentosa; Supplementation therapy,,,"['Anxiety', 'Blood test', 'Dysaesthesia', 'Electrocardiogram', 'Feeling cold', 'Heart rate', 'Heart rate increased', 'Hypersensitivity', 'Hypertension', 'Hypoaesthesia oral', 'Palpitations', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 1062176,,,U,"extreme/debilitating fatigue. Patient already have chronic fatigue and after receiving the vaccination, it made the chronic fatigue worse/ extremely tired; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included chronic fatigue. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced extreme/debilitating fatigue. Patient already have chronic fatigue and after receiving the vaccination, it made the chronic fatigue worse. Patient was extremely tired. Patient called to make sure that the side effect is common. The outcome of the event was not recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,,,UNK,,,Medical History/Concurrent Conditions: Chronic fatigue,,,['Fatigue'],1,PFIZER\BIONTECH, 1062177,NY,41.0,F,"the second dose; I have headache; I noticed the gums are swollen but not as big as the first time.; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (Lot number and expiry date not provided), via an unspecified route of administration on 26Jan2021 at single dose for COVID-19 immunization. Medical history included High Blood Pressure. Concomitant medication included amlodipine for High Blood Pressure. The patient previously took first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization and experienced ""gum on my right face was swollen"". It was reported that patient received the second dose and when she woke up, she had headache and then noticed the gums were swollen but not as big as the first time in Jan2021. No treatment received for the events. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/01/2021,,UNK,AMLODIPINE,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Gingival swelling', 'Headache']",2,PFIZER\BIONTECH, 1062178,,,F,"Fever; Chills; Headache; Tiredness and all of that; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient of unspecified age (niece) who received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The consumer's niece got the Pfizer-BioNTech COVID-19 Vaccine and did not have difficulty breathing; but did experience fever, chills, headache, tiredness and all of that on an unspecified date. Outcome of the events was unknown. Information about Lot/batch no has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1062179,FL,84.0,M,"Symptoms similar to thrush of mouth; I have sore throat and all inside my mouth is sore, my tongue is sore; Symptoms similar to thrush of mouth; I have sore throat and all inside my mouth is sore, my tongue is sore; Symptoms similar to thrush of mouth; I have sore throat and all inside my mouth is sore, my tongue is sore; Headache; Eyes are sore; Soreness in arm; This is a spontaneous report from a contactable consumer (patient himself). An 84-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3246), via an unspecified route of administration on the upper right arm, first dose at age 84 years on 15Jan2021, at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Patient had the COVID Vaccination on the 15Jan2021 and he had minor soreness in his arm for 2 days and it went away, it was gone by the 18Jan2021. On 23Jan2021, he started with the symptoms similar to the thrush of the mouth and he went to the doctor 27Jan2021 and they told him it was not thrush because he did not have the white coating in his mouth, and thought it was reaction to the Covid-19 Vaccination (Covid-19 Vaccine by Pfizer) and he has a sore throat and all inside his mouth is sore, his tongue is sore he has headache and his eyes are sore. Patient's doctor told him to take Vitamin C and Vitamin D and Zinc, and he took his first dose this morning 27Jan2021, after breakfast which are Vitamin C and Vitamin D, but he haven't taken the Zinc yet. The outcome of the event soreness in arm was recovered on 18Jan2021, while for the rest of the events, it was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,UNK,,,,,,"['Eye pain', 'Glossodynia', 'Headache', 'Oral pain', 'Oropharyngeal pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 1062180,,,F,"this morning she got fever; she is not feeling; she just had her arm sore last night.; This is a spontaneous report from a contactable consumer. A female patient (reporter's mother-in-law) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing COVID-19 from an unknown date. The patient's concomitant medications were not reported. The patient had COVID 19 and she still tested positive for it. She has had it for like almost two months now and they said that it was probably within her sinuses or something and they said that's why she was testing positive. They told her to go on and get her vaccine because she won't have anymore symptoms. So she went and got the vaccine and tonight she was fine. She just had her arm sore last night and this morning (27Jan2021), she got fever and she was not feeling well, she was feeling really bad. The outcome of events was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/01/2021,,UNK,,COVID-19 (had it for like almost two months now),,,,"['Malaise', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-1 test']",UNK,PFIZER\BIONTECH, 1062181,NC,,F,"Migraine; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (BNT162B2, lot EZ8982), via an unspecified route of administration from an unspecified date at SINGLE DOSE for Covid-19 immunisation. Medical history included asthma Concomitant medications included montelukast sodium (SINGULAIR), budesonide, formoterol fumarate (SYMBICORT) and adapalene (ADARET). The patient experienced migraine (taking Imitrex as treatment) on an unspecified date. The outcome of event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,SINGULAIR; SYMBICORT; ADARET,,Medical History/Concurrent Conditions: Asthma,,,['Migraine'],UNK,PFIZER\BIONTECH, 1062182,LA,26.0,M,"I am kind of feeling like hot like feverish; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received bnt162b2 (BNT162B2 also reported as Pfizer Covid 19 vaccine, lot EL8482), via an unspecified route of administration on 27Jan2021 at SINGLE DOSE for Covid-19 immunisation . Medical history was none. There were no concomitant medications. The patient experienced kind of feeling like hot like feverish on 27Jan2021 and took Tylenol as treatment. The outcome of event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['Pyrexia'],1,PFIZER\BIONTECH, 1062183,,,M,"high fever; This is a spontaneous report from a contactable consumer (patients brother). A male patient of an unspecified age receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, on 28Jan2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), on unknown date for COVID-19 immunization). The brother reported that the patient is currently experiencing high fever, on an unspecified date. The event was reported as non-serious. The patient had tests and procedures which included body temperature: high on unknown date. The clinical outcome of high fever was not recovered. Information on the lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,,,UNK,,,,,,"['Body temperature', 'Pyrexia']",2,PFIZER\BIONTECH, 1062184,,,U,"Cannot even talk; Chills; Nausea; Headache; Fatigue; I can't do anything I am just ""lying"" on bed; miserable; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no allergies. The patient reported they couldn't spend on the phone long; they experienced a lot of side effects from their vaccination on ""Monday."" They reported being vaccinated, first vaccination on ""Monday."" Tuesday the patient started getting chills and nausea and headache and fatigue and was still in bed. The reporter also stood up and then had a headache and was nauseous; further reporting they had been doing that for 3 days. The reporter inquired when the side effects would stop, further reporting feeling miserable and that they couldn't do anything, just lying on bed, cannot even talk. The clinical outcomes of chills, nausea, headache, fatigue, cannot talk, I can't do anything I am just lying on bed, and miserable were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Bedridden', 'Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Nausea', 'Speech disorder']",1,PFIZER\BIONTECH, 1062185,CT,79.0,F,"I experienced throat congestion:a feeling of thickness and swelling.; I experienced throat congestion:a feeling of thickness and swelling.; higher temp; arm ache; This is a spontaneous report from a contactable consumer for herself. A 79-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) on 30Jan2021 14:30 (Lot number: EL9264) via an unspecified route of administration in the right arm at single dose for COVID-19 Immunization. The patient's medical history included cholesterol but not high. The patient had no known allergies to medications, food, or other products. The patients concomitant medication included rosuvastatin at 5mg, aspirin (acetylsalicylic acid) at 81mg. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. The dose was received at 2:25pm. The dose was received on adverse event start date: 30Jan2021 at 2:25pm. patient waited the 15 minutes waiting period & went home. 95 minutes after (30Jan2021 16:00 PM) the injection she experienced throat congestion: a feeling of thickness and swelling. The symptoms lasted 35 minutes. Other reactions were normal: higher temp & arm ache. There was no treatment received for the adverse events. The outcome of the events was recovered on 30Jan2021 16:35. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/30/2021,0.0,UNK,ROSUVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID],,"Medical History/Concurrent Conditions: Cholesterol (cholesterol, but not high)",,,"['Body temperature', 'Body temperature increased', 'Pain in extremity', 'Pharyngeal swelling', 'Upper respiratory tract congestion']",1,PFIZER\BIONTECH, 1062186,MA,34.0,F,"Arm soreness at the site of injection. Not major or debilitating, but noticeable; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247 and expiration date: unknown.), via an unspecified route of administration on the left arm at the age of 34 years old on 04Feb2021 at 15:00 at a single dose for covid-19 immunisation. Patient is not pregnant. Medical history included allergies with sulfa drugs and acne. Concomitant medication included spironolactone for acne. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced arm soreness at the site of injection; not major or debilitating, but noticeable on 04Feb2021 at 16:00. No treatment was received in response to the event. The patient assessed the event as non-serious. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,WRK,SPIRONOLACTONE,,Medical History/Concurrent Conditions: Acne (spironolactone for acne); Sulfonamide allergy (Allergies: Sulfa drugs),,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1062187,,57.0,F,"fever; had body aches; chills; This is a spontaneous report from a non-contactable non-healthcare professional (consumer) reported that a 57-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included lupus. The patient concomitant medications were not reported. The patient previously took the first dose of bnt162b2 for COVID-19 immunization. On an unspecified date after the second shot, the patient ran a fever and had body aches and chills, which took 2 days to recover. It was unknown if the patient received treatment in response to the event. The patient recovered from the events on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: Lupus syndrome,,,"['Chills', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1062188,IN,75.0,F,"Fever; feels lousy; This is a spontaneous report from a contactable consumer reporting for herself. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL8982/expiration date: not provided), via an unspecified route of administration, on 26Jan2021 at 18:10 (at the age of 75 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included 3 cardiac stents on an unknown date. Concomitant medication was not provided. On 27Jan2021 at 15:00, the patient experienced fever all day. The patient's highest body temperature was on 27Jan2021 at 101.9 F and on 28Jan2021, the temperature was 101.4 F. On 27Jan2021 (time unspecified), the patient stated that she feels lousy. The outcome of the events fever and feels lousy was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Stent placement (3 cardiac stents),,,"['Body temperature', 'Malaise', 'Pyrexia']",1,PFIZER\BIONTECH, 1062189,PA,66.0,F,"tenderness under both armpits; Headache; Nausea; Diarrhea; felt like she had a fever that would come and go; felt like she had Covid again; She got hot; chills; really sick last night; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9261), via an unspecified route of administration in the left arm on 27Jan2021 at 11:10 (at the age of 66-years-old) as a single dose for covid-19 immunisation . Medical history included diabetes mellitus from 1995 and ongoing , ongoing hypertension , covid-19 from an unknown date and unknown if ongoing (Had Covid at Christmas). The facility in which the vaccine was received was a Workplace Clinic There were no concomitant medications. No other vaccines were given within 4 weeks. On 27Jan2021 The patient reported she was sick last night, tenderness under her arm pits, headache, nausea, diarrhea and she felt like she had a fever that would come and go. She got hot and then had chills. She felt like she had Covid again. Treatment included Zofran and it helped with the nausea. There was No physician office visit and No emergency room visit as a result of the events The clinical outcome of the events Nausea, diarrhea, was recovered on 27Jan2021, tenderness under both armpits recovered on 28Jan2021, Headache non recovered, Fever was recovering, while felt like she had Covid again, Feeling hot Chills and Sick unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,WRK,,Blood pressure high; Diabetes,Medical History/Concurrent Conditions: COVID-19 (She had Covid at Christmas),,,"['Axillary pain', 'Chills', 'Diarrhoea', 'Feeling abnormal', 'Feeling hot', 'Headache', 'Illness', 'Nausea', 'Pyrexia']",1,PFIZER\BIONTECH, 1062190,NV,33.0,M,"Swollen lymph nodes/lymph nodes are swollen on both sides; pain; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK9231), via an unspecified route of administration in the left arm on 27Jan2021 at 10:10 (at the age of 33-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. On 28Jan2021 at 07:00, the patient experienced swollen lymph nodes. The patient stated that the lymph nodes were swollen on both sides (or so he thought, as he couldn't see the uvula at all). The patient stated, ""it looks about the same right now"", but the pain (onset: Jan2021) has decreased. The patient stated he had taken several COVID-19 tests prior to the vaccination, on unspecified dates, all negative. The last test, a nasal swab was on Jan2021 with negative results. The clinical outcome of ""swollen lymph nodes/lymph nodes are swollen on both sides"" and pain was resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/01/2021,,PUB,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Lymphadenopathy', 'Pain', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1062191,,,M,tested positive for Covid after the vaccine; tested positive for Covid after the vaccine; This is a spontaneous report from a contactable consumer reported for her husband. A 7-decade-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the vaccine and then he tested positive for Covid after the vaccine. The outcome of the events was unknown. Information on Lot/Batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1062192,,77.0,U,"tested positive for the Covid virus on 02Feb; tested positive for the Covid virus on February 2nd.; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 3 patients. This is 2nd of 3 reports. A 77-year-old patient of unspecified gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Pharmacy technician, calling on behalf of three patients who tested positive after receiving the first dose of the Covid vaccine, asked when they can get the second dose of the Covid vaccine. They received their first dose on 16Jan2021 and tested positive for the Covid virus on 02Feb2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021138460 same drug/event, different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,02/02/2021,17.0,UNK,,,,,,"['Drug ineffective', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1062193,,,U,"Mild soreness at injection site; Myalgia; Tinnitus; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date (also reported as day 30 following dose 1) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 29Dec2020 (at the age of 79 years old) at a single dose in the left arm for covid-19 immunization and experienced neurosensory deafness in Rt ear./ total hearing loss in right ear; arm soreness; headache; myalgia; tiredness/episodic fatigue; mild cold intolerance; frontal headache (sinus like); stuffiness/Nasal congestion; postnasal drip and tinnitus in Right Ear. On unspecified date, the patient experienced mild soreness at injection site, myalgia 3/10 on day 1 and tinnitus (bilaterally, left more than right) on day 3 which was persisting but no hearing loss. The patient is scheduled to have an appointment with ENT on 18Feb2021 and will also have antibodies checked. Outcome of the event tinnitus was not recovered while outcome of all the other events was unknown. No follow-up attempts are possible. Information about batch/lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Myalgia', 'Tinnitus', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1062194,MI,,F,"Fever; chills; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller got her first shot last Saturday, then she woke up today with fever and chills (2021). The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,,,UNK,,,,,,"['Body temperature', 'Chills', 'Pyrexia']",1,PFIZER\BIONTECH, 1062195,CT,26.0,F,"Swollen lymph nodes (left side of neck, under arm, left chest); Dry mouth; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL 3247, expiry: unknown), via an unspecified route of administration in the left arm on 27Jan2021 12:45 at a single dose for COVID-19 immunization at a workplace clinic. Medical history included endometriosis, vertigo, pure hypercholesterolemia and allergies to sulfa, orange citrus and almonds. The patient has no covid prior to vaccination. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]), rosuvastatin calcium (CRESTOR), magnesium, ethinylestradiol, norgestimate (SPRINTEC) and multivitamin. The patient had no other vaccine in four weeks. The patient had PCR test via nasal swab on 04Feb2021 which was negative. The patient experienced dry mouth on 27Jan2021at 13:00 and swollen lymph nodes in the left side of neck, under arm, and left chest on 31Jan2021 at 13:00. The events were not treated. The event dry mouth recovered with sequelae on 31Jan2021 while swollen lymph nodes recovered with sequelae on 07Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,WRK,ADVIL [IBUPROFEN]; CRESTOR; MAGNESIUM; SPRINTEC,,Medical History/Concurrent Conditions: Allergy to nuts; Endometriosis; Fruit allergy; Pure hypercholesterolemia; Sulfonamide allergy; Vertigo,,,"['Dry mouth', 'Lymphadenopathy', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1062196,IL,40.0,F,"felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; dizziness; chills; headache; weird hallucinations; sore arm; felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, Lot unknown, second dose) intramuscular in left arm on 28Jan2021 at 09:15 (at the age of 40-years-old) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Past drug history included allergies: cefazolin sodium (ANCEF). Historical vaccine included BNT162B2 (Lot unknown, first dose) for COVID-19 vaccination on 05Jan2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had a sore arm and felt groggy on Thursday night (28Jan2021). The patient was feverish (highest temp was 100.4 F) with dizziness and chills and headache all day Friday, on 29Jan2021. On Friday night (29Jan2021) the patient had weird hallucinations (I hallucinated?, I guess, I was awake and talking to my husband and he said I seemed awake? but that my bed was breaking in half and sinking into the floor, and I kept telling him I couldn't breathe but he said I was breathing normally). No treatment was provided for the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache. The outcome of the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache was recovered on 31Jan2021. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The reported event hallucination was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,PVT,,,,,,"['Body temperature', 'Chills', 'Dizziness', 'Hallucination', 'Headache', 'Pain in extremity', 'Pyrexia', 'Somnolence']",2,PFIZER\BIONTECH,OT 1062197,FL,63.0,F,"tingling sensation left skull; fever 101.8; Mild left arm soreness; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date: 31May2021), via intramuscular route of administration in the left arm on 15Jan2021 10:05 at a single dose for COVID-19 immunization. Medical history included open cholecystectomy in 1990, hypertension, and sleep apnoea (CPAP). The patient's concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22 Dec2020 and experienced fever, nausea, vomiting, diarrhea, metallic taste in mouth, Loss of taste/smell, minimal soreness at the site of injection, strange sensation of tingling in her skull, chills, dry mouth, feels like she has no saliva, tongue felt a little bit too dry, extremely tired, thirst, and altered taste. The patient experienced mild left arm soreness on 15Jan2021 and fever 101.8 on 16Jan2021 23:00. Patient took ibuprofen 400mg and ondansetron (ZOFRAN) 4mg. The patient also experienced tingling sensation left skull continues as described. The patient had no cough, sore throat, stuffy or runny nose. She had no shortness of breath, no nausea vomiting or diarrhea, and no loss of taste/smell or metallic taste in mouth. The patient underwent lab tests and procedures which included body temp: 99.7 on 15Jan2021 18:00, 101.8 on 16Jan2021 11 PM, 99.5 on 16Jan20213 PM, 99.8 on 16Jan2021 10 PM, 99.5 on 17Jan2021 9:00, 99.8 on 17Jan2021 8 PM, 100 on 17Jan2021 10 PM, 99.4 on 18Jan2021 07:00, 99.7 on 19Jan2021 16:00, 98.6 on 20Jan2021 11 AM. Outcome of tingling sensation left skull was not recovered, of remaining events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Cholecystectomy; Hypertension; Sleep apnoea (CPAP),,,"['Body temperature', 'Paraesthesia', 'Pyrexia', 'Vaccination site pain']",2,PFIZER\BIONTECH,OT 1062198,MA,,M,"Sore arm; aches; fever; chills; This is a spontaneous report from a non-contactable consumer (Patient). An adult male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Not available/provided to reporter at the time of report completion), via unknown route of administration on left arm on 10Feb2021 at 17:00 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Jan2021 on left arm for COVID-19 immunisation. On 11Feb2021 at 12:00 PM, the patient experienced sore arm, fever, chills, aches. The patient assessed the events as non-serious. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient not recovered from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/11/2021,1.0,WRK,,,,,,"['Body temperature', 'Chills', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH, 1062199,NJ,56.0,F,"almost passed out; dizzy; clammy; hot; kept taking my Blood Pressure and pulse ox. Both very, very low; kept taking my Blood Pressure and pulse ox. Both very, very low; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot: reported as 96.8), via an unspecified route of administration in the left arm on 31Jan2021 14:15 at a single dose for covid-19 immunization. The patient's medical history included Lupus, Fibro, Hyperthyroidism, Hashimoto's, IBS all from an unknown date. Patient has no known allergies. Concomitant medication included pantoprazole, xylometazoline hydrochloride (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]), vitamin c [ascorbic acid], vitamin d3 and calcium (CALCIUM). 15 minutes after the shot while waiting, 8 minutes into it the patient felt dizzy, clammy, hot, and almost passed out. Nurse gave patient oj, oxygen, Epipen, checked sugar, and kept taking her blood pressure and pulse ox. Both very, very low until it came back up within 20 minutes. The patient declined hospital due to feeling better. Called the doctor next day to discuss what happened. She recommended no 2nd shot. The outcome of the events was recovered. The patient has not had Covid prior to vaccination and patient has not tested post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/31/2021,01/31/2021,0.0,SEN,PANTOPRAZOLE; SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; CALCIUM,,Medical History/Concurrent Conditions: Fibroma NOS; Hashimoto's disease; Hyperthyroidism; Irritable bowel syndrome; Lupus syndrome,,,"['Blood pressure decreased', 'Blood pressure measurement', 'Cold sweat', 'Dizziness', 'Feeling hot', 'Heart rate', 'Heart rate decreased', 'Loss of consciousness']",1,PFIZER\BIONTECH, 1062200,PA,55.0,M,"severe prolonged cricopharyngeal spasm; This is a spontaneous report from a contactable physician (patient) A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 09Feb2021 at single dose for covid-19 immunisation at hospital. Medical history included rheumatoid arthritis, allergy to penicillin, asthma vaccine, pollen, cats, sea food and latex. Concomitant medication included methotrexate (unknown manufacturer) and methylprednisolone (unknown manufacturer). The patient experienced severe prolonged cricopharyngeal spasm on 09Feb2021 with outcome of recovering. The event resulted in Doctor or other healthcare professional office/clinic visit. No treatment was performed due to the event. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported severe prolonged cricopharyngeal spasm and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/09/2021,0.0,PVT,METHOTREXATE; METHYLPREDNISOLONE,,Medical History/Concurrent Conditions: Allergic to cats; Allergy to vaccine; Latex allergy; Penicillin allergy; Pollen allergy; Rheumatoid arthritis; Seafood allergy,,,['Oropharyngeal spasm'],UNK,PFIZER\BIONTECH, 1062201,,27.0,F,"body aches; headache; chills; arm soreness; This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on Jan2021 12:00 PM for covid-19 immunization on the left arm, also at age of 27-year-old. The most recent COVID-19 vaccine facility type was Workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient medical history and concomitant medications were not reported. The patient experienced body aches, headache, chills, arm soreness on Feb2021 with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,WRK,,,,,,"['Chills', 'Headache', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH, 1062202,CA,,F,"rash; a bit nauseous; I felt tingling my tongue; light headed; top of my palate strange; taste of metal in my mouth; swelling; inside of mouth swelling; loss of vision; something weird on liver; lumps on skin; kidney is hurting; vaccine took away all the depression; This is a spontaneous report from a contactable consumer (the patient). A 67-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 10Feb2021 (at the age of 67-years-old) for COVID-19 immunization. Medical history included high blood pressure, glaucoma and depressed from an unknown date. Concomitant medications were not reported. The patient had taken 10mg of antihistamine around 30 minutes before the vaccine (unspecified). The patient previously took iodine and experienced allergic reaction and flu vaccine and had an allergic reaction. On 10Feb2021, the moment they finished putting the shot, the patient experienced rash, nausea, swelling, tingling on the tongue, palette and inside of mouth, top of palate strange, metal taste, and light headed (felt like she was flying). The patient was hospitalized for the events rash, nausea, swelling, tingling on the tongue, palette and inside of mouth, top of palate strange, metal taste, felt nauseous, and light headed on an unknown date. The patient experienced a loss of vision reported as she cannot read her computer because the letters are gray; something weird on her liver, has lumps on her skin and kidney is hurting on an unknown date. The patient also experienced the vaccine took away all the depression and has made her active, now does everything and has been super positive, feels her internal battery is full. The clinical outcome of the events rash, nausea, paraesthesia oral, dizziness, palatal disorder, dysgeuisia, swelling, mouth swelling, blindness, liver disorder, skin swelling, renal pain and therapeutic response unexpected was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/10/2021,02/10/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure high; Depressed mood; Glaucoma,,,"['Blindness', 'Dizziness', 'Dysgeusia', 'Liver disorder', 'Mouth swelling', 'Nausea', 'Palatal disorder', 'Paraesthesia oral', 'Rash', 'Renal pain', 'Skin swelling', 'Swelling', 'Therapeutic response unexpected']",1,PFIZER\BIONTECH, 1062203,GA,66.0,F,"Took benadryl for injection site inflammation; Swelling; Itching; heat at injection site occurring over the week post-injection; Knot; diarrhea which is like I had when I had Covid last fall.; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), on 01Feb2021 at 15:00 (at the age of 66-years-old) at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Doctor's office/urgent care. No other vaccine was given within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Other medical history included irritable bowel syndrome (IBS), and high blood pressure. Concomitant medications included linsinopril, estradiol, naproxen sodium (ALEVE), tocopherol (VIT. E), colecalciferol (VITAMIN D), multivitamin. On 03Feb2021 the patient experienced swelling, itching, knot, heat at injection site occurring over the week post-injection, injection site inflammation, as well as diarrhea which is like she had when had Covid last fall. The events resulted in emergency room/department or urgent care. As treatment received it was reported the patient took Benadryl for injection site inflammation. The events were resolving. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/03/2021,2.0,OTH,LISINOPRIL; ESTRADIOL; ALEVE; VIT. E; VITAMIN D,,Medical History/Concurrent Conditions: Blood pressure high (high blood pressure); COVID-19 (if_covid_prior_vaccination: Yes); Irritable bowel syndrome (IBS),,,"['Diarrhoea', 'Vaccination site inflammation', 'Vaccination site nodule', 'Vaccination site pruritus', 'Vaccination site swelling', 'Vaccination site warmth']",1,PFIZER\BIONTECH, 1062204,MA,21.0,F,"fatigue; worse sore arm; This is a spontaneous report from a contactable consumer (patient's father). A 21-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration in the left arm on 07Jan2021 at 15:00 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date were unknown) on 17Dec2020 for COVID-19 immunization and experienced arm was kind of sore and she was pretty tired, for which no admission to the hospital was involved and the patient did not receive any treatment. The patient's medical history was not reported. There were no concomitant medications. There were no other products taken together with the vaccine. The patient experienced worse sore arm on 07Jan2021 at 20:00 and experienced fatigue the next day on 08Jan2021 at 08:00. The adverse events (AEs) did not require any visit to an emergency room or a physician office. The patient did not receive any treatment for the events. The patient recovered from the event ""worse sore arm"" on an unspecified date, while the outcome of the event ""fatigue"" was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,,,,,,"['Fatigue', 'Pain in extremity']",2,PFIZER\BIONTECH, 1062205,NC,43.0,F,"she may have been panicked; she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems; she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems; left arm soreness; she felt ugh, like she was getting sick; sensation like she was going to pass out; Headache; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EM9810, intramuscular on left deltoid on 04Feb2021 as single dose (at the age of 43 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Pacemaker in Jun2019 and ongoing, sick sinus syndrome, and pre-existing cardiac arrhythmia ongoing. Historical vaccine included Tetanus, Tetanus made her arm sore, the soreness from tetanus was worse than the soreness from COVID vaccine since it lasted a week with tetanus, no lot number reported. No concomitant medication was reported. The patient experienced she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems on 05Feb2021 considered medically significant with outcome of not recovered, Within 15 minutes after receiving the vaccine she felt like she was going to pass out three times on 04Feb2021 considered medically significant and recovered on 04Feb2021, she may have been panicked on unspecified date with outcome of unknown, left arm soreness on 05Feb2021 with outcome of recovered on Feb2021, and she felt ugh, like she was getting sick on 05Feb2021 with outcome of unknown. The patient did not receive treatment for events. She stayed an extra 30 minutes to be monitored after the initial waiting of 15 minutes since she had to drive home, then she felt better. She has not called her cardiologist since she has the history of arrhythmias. She had the more arrhythmias start on the evening of the 05Feb2021, states it was weird because it seems to happen more in the evening between 6 and 9pm, sometimes as late as 10pm. However, 'yesterday' it started happening during the day, and it is more frequent, not constant, it just happens. States it is hard not think about it when her heart is having hiccups since that is what it feels like. She knows what it feels like because when her pacemaker goes off ventricularly she can feel it. She had arrhythmias before the vaccine but has not had issues with arrhythmias continuously. She was diagnosed with sick sinus syndrome and they do not know if it is cardiology or neurology, states it has been an issue for her for the last two years (2019). Lab data included weight of 284-286. She is asking if there is any data that supports her getting the second dose on 25Feb2021. She has read that some people tend to have more side effects with the second dose. The patient had no prior vaccinations (within 4 weeks).; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between events worsening arrhythmia and pre-syncope and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,UNK,,Cardiac arrhythmia; Pacemaker insertion (cardiac),Medical History/Concurrent Conditions: Sick sinus syndrome,,,"['Arrhythmia', 'Condition aggravated', 'Headache', 'Malaise', 'Panic reaction', 'Presyncope', 'Vaccination site pain', 'Weight']",1,PFIZER\BIONTECH,OT 1062206,,71.0,F,"really high blood sugar, some mornings over 300 mg; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date in Feb2021 (a week ago) as a single dose for COVID-19 vaccination. Medical history included ongoing diabetic from an unknown date. Concomitant medications were not reported (reported she takes 'sugar medicine' for diabetes). In Feb2021, since receiving the vaccine, the patient experienced sugar levels have been high, the first 3 or 4 days they were really high, some mornings they were over 300mg. The patient underwent lab tests which included sugar levels which showed over 300mg on an unknown date. The patient was treated for the blood sugar high with taking half of her sugar medicine. The clinical outcome of the event blood sugar increased was recovering reported as the levels were lowering a little. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,Diabetic (takes sugar medicine),,,,"['Blood glucose fluctuation', 'Blood glucose increased']",1,PFIZER\BIONTECH, 1062207,MI,74.0,M,"Flu like symtoms; chill; sligh headache; a little tired; This is a spontaneous report from a contactable other hcp (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EM9810), via an unspecified route of administration on 08Feb2021 09:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on an unknown date for covid-19 immunization. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. The patient experienced flu like symtoms, chill, sligh headache, temp at 97.8 and a little tired on 12Feb2021 09:00 AM. Patient didn't receive treatment for the adverse events. The outcome of events was unknown. The events were reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/12/2021,4.0,UNK,,,,,,"['Body temperature', 'Chills', 'Fatigue', 'Headache', 'Influenza like illness']",2,PFIZER\BIONTECH, 1062208,IL,33.0,F,"brain fog; Bell's palsy on left side of face; vision has been off/ Vision is blurry; Numbness and tingly/burning sensation in right leg; Numbness and tingly/burning sensation in right leg; Numbness and tingly/burning sensation in right leg; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9264 and Expiration Date: May2021), via an unspecified route of administration in the left arm on 02Feb2021 at 17:45 at 33-years-old at a single dose for COVID-19 immunization; with no other vaccines administered within four weeks of the bnt162b2 administration. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included alprazolam (XANAX) taken for an unspecified indication from an unspecified date to an unspecified date, prednisone (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unspecified date to 16Feb2021. The patient experienced the following events and outcomes: Bell's palsy on left side of face (medically significant) on 06Feb2021 12:00 with outcome of recovering, vision has been off/ vision is blurry (medically significant) on 06Feb2021 12:00 with outcome of recovering, numbness and tingly/burning sensation in right leg (medically significant) on 06Feb2021 12:00 with outcome of recovering, brain fog (medically significant) on an unspecified date with outcome of unknown; all of which required a physician office visit. The clinical course was reported as follows: The patient received the first dose of the Pfizer COVID 19 vaccine, she began having symptoms on the following Saturday and was seen by her doctor and diagnosed with Bell's Palsy. The patient stated she has reported this via VSafe and the Pfizer website. The patient also reported other symptoms that have not been reported as follows: had tingling in both legs, brain fog, and vision has been off. The patient was not sure if it was related to the vaccine or steroids. The patient wanted to know if she should get the second dose. The patient had been on a steroid, so she did not know if she should wait to get the second dose. The patient just stopped the steroid on 16Feb2021, and the second dose was scheduled for 23Feb2021. The patient also said she had other symptoms that she had not reported and she said she had tingling that started in one leg now in both legs, brain fog and her vision was off and she was not sure if that was related to the vaccine or the steroid (later clarified as prednisone). The patient was not taking the steroids at the time of diagnosis. ""Correct I mean it started after the vaccine, but I was also on medication (Clarified as Prednisone) so I am not really sure what the difference is at this time."" Treatment in response to event: the patient stated, ""No I mean for the tingling in my leg I have been just putting heat and Ice on it but I have not done anything actual big treatment and then for my eyes no, my doctor is not sure what is related to the Bell's Palsy and what is to medication."" The patient underwent lab tests and procedures which included lab work: unknown result on an unspecified date (patient stated, ""Yes, I have many""). Therapeutic measures were taken as a result of facial paralysis, hypoaesthesia, burning sensation, and paraesthesia; which included steroids and anti-viral and anti-nausea medicine. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/06/2021,4.0,UNK,XANAX; PREDNISONE,,Medical History/Concurrent Conditions: Anxiety,,,"['Burning sensation', 'Facial paralysis', 'Feeling abnormal', 'Hypoaesthesia', 'Laboratory test', 'Paraesthesia', 'Vision blurred']",1,PFIZER\BIONTECH, 1062209,,,F,"lady who injected the patient was a little upset since it bleed a little after being injected; bruise on her arm/Injection site bruising; she felt a little light headedness; little nauseated; Slight 'tenderness'; This is a spontaneous report from a contactable consumer (female). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry not reported), as second dose via an unspecified route of administration on the arm on 11Feb2021 at single dose for covid-19 immunization. Medical history included slow clotting problem (when she was little/was never diagnose with a disorder) and first vaccination (she did not have any bruise). The patient's concomitant medications were not reported. It was reported that the patient had the second dose of the Pfizer COVID-19 vaccine yesterday (11Feb2021). The lady who injected the patient was a little upset since it bleed a little after being injected. The patient stated, ""You are very good that did not hurt. She said not that good. You are bleeding. You should not be bleeding but I do not even know she said you should not be bleeding but she said and then she kept patting my arm on the spot that it was, where she injected me and she said yeah that is right where I should inject you"". The patient said that she was fine and was not concerned with the AEs but she wanted to know if the vaccine was still effective even though she bled. She also said that she developed a pretty big bruise on her arm/injection site bruising. The patient was injected in the deltoid muscle. She said when she removed the band aid there was only little blood transferred there. The patient said that her doctor when she was little told her that she has a slow clotting problem but was never diagnose with a disorder. The patient said that she felt a little light headedness or a little nauseated after being injected. The patient's concerns were not to the bruising, did not concern her at all. Her main concern was to make sure that she did not have symptoms and she wondered afterwards, the patient ended consoling her. The lady was concerned that may be the patient was on blood thinners. The patient said that she was not on blood thinners. The patient had a slight 'tenderness' never really caused her a problem. Just breathe a little bit easier and when she got home and took off the Band-Aid there was really hardly any blood there but she had the first vaccination she did not have any bruise. The patient have a huge bruise on her arm this time and that was okay. The patient bruise equally too. But she just wanted to make sure that since they really did not have symptoms that the vaccine was really injected into the area where it was going to be affected for her. The patient assessed the case as non-serious. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/11/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Clotting disorder (when she was little/was never diagnose with a disorder); Vaccination (she did not have any bruise),,,"['Dizziness', 'Nausea', 'Tenderness', 'Vaccination site bruising', 'Vaccination site haemorrhage']",2,PFIZER\BIONTECH, 1062210,TN,80.0,F,"Feet felt stiff and bone in right leg felt strange; Feeling dizzy and faint like; tired; Sinuses started to drain; itching on the right shoulder (where she had the vaccine); Itching on right side of arm near elbow, middle part of stomach and neck; pain in the shoulder; This is a spontaneous report from a contactable consumer, the patient. AN 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6201, Expiry date: 30Jun2021) intramuscularly in the right arm on 11Feb2021 at 13:00 (at the age of 80-years-old) as a single dose for COVID-19 immunization. Medical history included highly sensitive and highly allergic to everything from food to medicine; had been through near death with allergies; allergic to penicillin, iodine and shellfish; high blood pressure, eye disorder (unspecified), allergies with her sinuses. Concomitant medications were not reported, but the patient took unspecified high blood pressure and eye medication. The patient previously took dextropropoxyphene hydrochloride (DARVON), ether and castor oil and experienced allergies; sulfamethoxazole and trimethoprim (BACTRIM) for severe acute sinusitis on Jan2021 (about a month ago). On 11Feb2021 at 13:20, the patient start feeling dizzy and faint like, and felt a little tired. She came home and went to bed and on 11Feb2021, had itching on the right shoulder (where she had the vaccine) and on the right side of the arm near the elbow, the middle part of the stomach and the neck (itching came and went) and later, her sinuses started to drain. On 12Feb2021, the patient's feet felt stiff and the bone in the right leg felt strange. On an unspecified date in Feb2021, the patient had pain in the shoulder. The patient queried if she can take aspirin for the pain in the shoulder and diphenhydramine (BENADRYL) if the itching comes back. The clinical outcome of pain in the shoulder was unknown, of ""itching on right side of arm near elbow, middle part of stomach and neck"", ""feeling dizzy and faint like"", tired, sinuses started to drain, ""feet felt stiff and bone in right leg felt strange"" and ""itching on the right shoulder (where she had the vaccine)"" was resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Allergic sinusitis; Blood pressure abnormal; Eye disorder; Highly allergic (highly sensitive and highly allergic to everything from food to medicine); Iodine allergy; Near death experience; Penicillin allergy; Shellfish allergy,,,"['Arthralgia', 'Dizziness', 'Fatigue', 'Musculoskeletal stiffness', 'Paranasal sinus hypersecretion', 'Pruritus', 'Vaccination site pruritus']",1,PFIZER\BIONTECH,OT 1062211,NV,75.0,M,"Fever / He was at a feverish point; his body was warm and getting warmer and warmer; sweating; Chills; This is a spontaneous report from a contactable consumer reporting for himself. This 75 years old male consumer received the first single dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9261) on 28Jan2021 at 09:50, in left arm, for COVID-19 immunisation. The patient was a disable war veteran; the Military gave him the COVID vaccine. Medical history included malaria (and another unspecified condition during his military service, they used ""IVs to bring him back"" and he even had a spinal tap, he was also in ""a coma, on his way out to the next"" and they said he was shaking like a leaf on the tree), skin problems (he had already been under the (government organization) care of malaria and skin problems), prostate problems, back problems since the war, he was still in a back brace for his back problems (he had been wearing it since the 60's), major spinal surgery in Mar2019 where his L1 and L5 were taken out (he lost a lot of fluid as a result of this surgery). Since they took his L1-L5, he had no real body control of his lower extremities and due to this he was awarded money from the (government organization). The patient received an unspecified influenza vaccine in the past, on an unknown date, for immunization. Concomitant medications were not reported. On 12Feb2021 at 03:30 AM, the patient experienced fever, he described his body was warm and getting warmer and warmer and was sweating. He was at a feverish point, his sheets he was sweating and wet from his back to feet. He also had chills. He got up thinking this reaction was from the COVID vaccine, he had an Enurse drink in his fridge and took powdered acetylsalicylic acid (ASPIRIN) and then he laid there and let his body go through the changes. He knew that his body can recover from heat. He went to sleep, woke up and had no more chills; he was sweating, but it was gone, his body was normal, he was under the covers. It was like how his normal body just took it like penicillin, it did the same thing. The events resolved on 12Feb2021 at 07:00 AM. His second vaccine dose was schedule on 18Feb2021 at 9:50 AM.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,02/12/2021,15.0,MIL,,"Brace user (for his back problems, wearing it since the 60's); Disability","Medical History/Concurrent Conditions: Back disorder (since the war, he was still in a back brace for his back problems); Coma (due to another unspecified condition during his military service); Fluid loss (his L1 and L5 were taken out (he lost a lot of fluid as a result of this surgery)); Loss of control of legs; Malaria (and another unspecified condition during his military service); Prostatic disorder; Shaking (due to another unspecified condition during his military service); Skin disorder (he had already been under the (government organization) care of malaria and skin problems); Spinal laminectomy & removal of disc (his L1 and L5 were taken out (he lost a lot of fluid as a result of this surgery)); Spinal tap (due to another unspecified condition during his military service)",,,"['Chills', 'Feeling hot', 'Hyperhidrosis', 'Pyrexia']",1,PFIZER\BIONTECH, 1062212,,58.0,M,"a nursing student took out the needle and watered down vaccine came out with blood (not typical); a nursing student took out the needle and watered down vaccine came out with blood (not typical); This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 11Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called regarding an incident that took place yesterday (11Feb2021) at the vaccine center. The patient asked about a loss of vaccine when an injection causes bleeding. He went to a hospital and a nursing student took out the needle and the vaccine came watering down with blood which was not typical. He was asking what should be done on this case, if there were any cases like this, how much vaccine came out, and if it required re-vaccination. It was given intramuscularly, but however when the needle was removed, a little geyser of blood came out of the hole. That's where the question lies, he asked if he needs to be concerned. The only person who would have that information would be Pfizer or CDC. His physician was not educated regarding this. He was asking about the loss of vaccine when there's bleeding and what to do. He was a journalist and thought it would be better if a scientist who can answer and give an answer more directly would speak to him. He already has part of this written up and will publish this. He wanted more information regarding this. He believes more people have experienced this and there was more information available for this. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/11/2021,0.0,UNK,,,,,,"['Underdose', 'Vaccination site haemorrhage']",UNK,PFIZER\BIONTECH,OT 1062213,NC,68.0,F,"needle was removed from arm, blood streamed down her arm about 5-6 inches; This is a spontaneous report from a contactable consumer (husband reporting for wife). This 68-year-old female patient female received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6201, unspecified route in arm on 09Feb2021 as single dose (at the age of 68 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. The patients husband reported when the needle was removed from his wife's arm, blood streamed down her arm about 5-6 inches on 09Feb2021. The doctor who removed the needle immediately put a round bandage on the injection site and then the stream stopped but before there was a steady stream of blood running down her arm. Patient's husband is wondering if she could have lost any of the vaccine when this happened. The caller would like to know if there is any possibility the vaccine might have come out in the blood. Patient's husband heard the first dose given in (name of city) had leaking from the syringe prior to injection and was an invalid dose. Patients husband reported ""the doctor who did the vaccine did put the needle all the way in and pushed the plunger all the way in."" Patient's husband is wondering about how much vaccine is remaining for his protection and the potential need for revaccination. Outcome of event needle was removed from arm, blood streamed down her arm about 5-6 inches was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,02/09/2021,0.0,UNK,,,,,,['Vaccination site haemorrhage'],2,PFIZER\BIONTECH, 1062214,NH,42.0,F,"light headed and dizzy, mild; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first single dose of BNT162B2 (Pfizer, solution for injection, lot number: EL3247, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 11Feb2021 10:30 to 11Feb2021 10:30 at SINGLE DOSE for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient had no relevant medical history. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. There was no other medication received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other medication received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced light headed and dizzy, mild; lasted day of injection on 11Feb2021 16:00. The event was considered as non-serious by the reporter. No treatment received for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered from the event on an unspecified date in Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Dizziness'],1,PFIZER\BIONTECH, 1062215,NY,75.0,M,"anaphylactic reaction with tightness around his jaw area, ears, and throat, and tightness in upper chest that lasted intermittently for 4 days; anaphylactic reaction with tightness around his jaw area, ears, and throat, and tightness in upper chest that lasted intermittently for 4 days; anaphylactic reaction with tightness around his jaw area, ears, and throat, and tightness in upper chest that lasted intermittently for 4 days; anaphylactic reaction with tightness around his jaw area, ears, and throat, and tightness in upper chest that lasted intermittently for 4 days; This is a spontaneous report from a contactable consumer (the patient). A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264), via an unspecified route of administration on 05Feb2021 at 11:10 AM (at the age of 75 years), as a single dose for COVID-19 immunization. Medical history included kidney transplant. Concomitant medication included tacrolimus, mycophenolate mofetil (MYCOPHENOLATE), prednisone. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL8982), on 14Jan2021 for COVID-19 immunization). On 05Feb2021 at around 18:00 PM, the patient had what he believed was an anaphylactic reaction with tightness around his jaw area, ears, and throat, and tightness in upper chest (he clarified that upper chest as where the neck meets the chest. It may have been a little lower, but not that far down that he would have worried. It was the upper chest where the neck meets the chest. Not in the chest to the left or right). It lasted intermittently for 4 days. He reported that it was not continuous, it would come for 2-3 hours dissipate and then come again. It wasn't all day and all night. He reported ""I'm better now"". The clinical outcome of anaphylactic reaction with tightness around his jaw area, ears, and throat, and tightness in upper chest was recovered on 10Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,TACROLIMUS; MYCOPHENOLATE; PREDNISONE,,Medical History/Concurrent Conditions: Kidney transplant,,,"['Anaphylactic reaction', 'Chest discomfort', 'Muscle tightness', 'Throat tightness']",2,PFIZER\BIONTECH, 1062216,MN,76.0,F,"Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262; Expiration date was not reported) on 03Feb2021 (12:15) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the physician's office. Medical history included vulvodynia; back issues; sulfa allergy; penicillin (PCN) allergy; and allergy to ""mycins"". Concomitant medication included estrogens conjugated (PREMARIN) and propranolol. The patient previously took morphine sulfate, and had drug allergy; lansoprazole (ZOLANAS), and had drug allergy; and tetanus vaccine, and had allergy to the vaccine. The patient was not pregnant at the time of vaccination. On 11Feb2021 (16:30), the patient had induration/3-inch diameter raised injection site that was hot, very red, itchy and hard around it. The reported events resulted into physician's office visit. The patient did not receive any treatment for the reported events. The outcome of the events, 'induration/3-inch diameter raised injection site that was hot, very red, itchy and hard around it', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/11/2021,8.0,PVT,PREMARIN; PROPANOLOL,,Medical History/Concurrent Conditions: Allergic reaction to antibiotics; Back disorder; Penicillin allergy; Sulfonamide allergy; Vulvodynia,,,"['Vaccination site erythema', 'Vaccination site induration', 'Vaccination site pruritus', 'Vaccination site swelling', 'Vaccination site warmth']",1,PFIZER\BIONTECH, 1062217,PA,71.0,F,"severe glaucoma; Intermittent itching, numbness around my left eye & down cheek; Intermittent itching, numbness around my left eye & down cheek; Visual field defect; Intermittent itching, numbness around my left eye & down cheek; Intermittent itching, numbness around my left eye & down cheek; This is a spontaneous report from a contactable consumer. A non-pregnant 71-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EM9810), via an unspecified route of administration in the right arm on 05Feb2021 at 15:30 at 71-years-old at a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the bnt162b2 administration. Medical history included controlled blood pressure high (HBP) from an unknown date and unknown if ongoing, glaucoma from an unknown date and unknown if ongoing; ""known allergies: comparing."" Concomitant medications included unspecified medications taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of the vaccination. On 08Feb2021 at 07:30, the patient experienced: severe glaucoma (medically significant), intermittent itching, numbness around my left eye & down cheek (non-serious), visual field defect (non-serious); with no treatment received. The clinical outcome of the events was not recovered. The patient was not tested for COVID prior to the vaccination and post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/08/2021,3.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure high; Glaucoma,,,"['Eye pruritus', 'Glaucoma', 'Hypoaesthesia', 'Hypoaesthesia eye', 'Pruritus', 'Visual field defect']",1,PFIZER\BIONTECH, 1062218,VA,93.0,M,"seizure; unresponsive for 20 minutes; This is a spontaneous report from a contactable physician reporting for himself. A 93-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 10Feb2021 at 15:45 (at the age of 93 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included dementia from an unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 21Jan2021 (at the age of 93 years old) as a single dose in the deltoid right for COVID-19 IMMUNIZATION. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included atorvastatin and levothyroxine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021 at 13:30, the patient experienced a seizure and was unresponsive for 20 minutes. Treatment for the events included careful observation and airway protection. The outcome of the events seizure and unresponsive was recovered on an unspecified date in Feb2021. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Seizure and Unresponsive to stimuli cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/12/2021,2.0,PVT,ATORVASTATIN; LEVOTHYROXINE,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: dimentia,,,"['Seizure', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH, 1062219,CT,41.0,F,"MRI showing inflammatory lesion of the Pons/Single lesion appearing inflammatory in nature found in the pons at origin of cranial nerve 6; single lesion appearing inflammatory in nature found in the Pons at origin of Cranial Nerve 6; Development of double vision/double vision with right gaze and head turning; mild chills; headache; significant diarrhea; vision noted to be off; This is a spontaneous report from a contactable other health care professional, the patient. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 14Jan2021 at 01:15 (at the age of 41-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included spontaneous coronary artery dissection with stenting (reported as ""five years ago"") and complex migraines from an unspecified date. The patient is allergic to Tramadol, Codeine and Novocaine. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899) on 23Dec2020 at 01:15 AM as a single dose in the left arm for COVID-19 immunization.The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diltiazem (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN).The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported the development of double vision on 25Jan2021 at 06:00. She was hospitalized and remained hospitalized for three days. She reports having had an MRI (date not specified) which showed an inflammatory lesion of the Pons. She further described the events as follows: Initially mild chills and headache ""the day after"" developing into significant diarrhea for four days and on and off diarrhea for several weeks. One week after vaccine vision noted to be off but no official work up developing into double vision with right gaze and head turning three weeks after vaccine. She also stated that there was a single lesion appearing inflammatory in nature found in the Pons at origin of Cranial Nerve 6. Treatment received included Solumedrol and Pepcid infusion. Lab data included an MRI on an unspecified date which showed inflammatory lesion of the Pons and COVD-19 testing as follows: SARS-CoV-2 Nasal Swab PCR test on 20Jan2021 and on 11Feb2021 both of which were negative. The clinical outcomes of brain inflammation, double vision, chills, headache, diarrhea, vision decreased and cranial nerve disorder were reported as recovering. No follow-up attempts are possible. No further information expected.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/14/2021,01/01/2021,,PVT,DILTIAZEM; ASPIRIN,,Medical History/Concurrent Conditions: Coronary artery dissection (5 years ago with stenting); Migraine,,,"['Chills', 'Cranial nerve disorder', 'Diarrhoea', 'Diplopia', 'Headache', 'Magnetic resonance imaging', 'Noninfective encephalitis', 'SARS-CoV-2 test', 'Visual impairment']",2,PFIZER\BIONTECH, 1062220,MA,43.0,M,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration in left arm on 27Jan2021 11:00 (at age 43-years-old) at a single dose for COVID-19 immunization. Medical history included blood pressure. The patient did not have COVID prior vaccination. No known allergies. Concomitant medications included atorvastatin (LIPITOR), amlodipine besilate (NORVASC), sildenafil citrate (VIAGRA), and amfetamine sulfate (AMPHETAMINE SALTS). The patient tested positive for SARS-CoV-2 on 12Feb2021, patient was symptomatic (cough, diarrhea, headache) since 06Feb2021. Covid test post vaccination via Nasal Swab, (NAAT Aptima SARS-CoV-2 assay) on 12Feb2021 with covid test result Positive. Treatment received included Aspirin. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/12/2021,16.0,WRK,LIPITOR [ATORVASTATIN]; NORVASC; VIAGRA [SILDENAFIL CITRATE]; AMPHETAMINE SALTS,,Medical History/Concurrent Conditions: Blood pressure abnormal,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1062221,VA,,M,"passed some blood when he went to the bathroom; fever of 100 degrees; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unknown age (reported as 73 with no units provided) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 12Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 13Feb2021, the patient passed some blood when he went to the bathroom and had a fever of 100 degrees Fahrenheit. The clinical outcomes of the passed some blood when he went to the bathroom and fever were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/13/2021,1.0,UNK,,,,,,"['Body temperature', 'Haemorrhage', 'Pyrexia']",1,PFIZER\BIONTECH, 1062222,IN,72.0,F,"Trouble breathing; nausea; severe headache/excruciating headache; Feeling generally unwell to the point I almost went to the emergency room/terribly unwell feeling; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non-preganant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EN5318, via an unspecified route of administration on 02Feb2021 15:45 (at the age of 72 years old) for COVID-19 vaccination, Unspecified other vaccine (Pfizer) on 02Feb2021, dose number in the left arm for an unspecified indication.Medical history included asthma from an unknown date and unknown if ongoing (asthma under control), pancreatitis chronic from an unknown date and unknown if ongoing (Occasional chronic pancreatitis), Blood pressure from an unknown date and unknown if ongoing, drug allergies from an unknown date and unknown if ongoing. Concomitant medication included Blood pressure medication. The patient previously took morphine and experienced allergies morphine and sulfa and experienced allergies sulfa. The patient received the vaccination at the hospital. On 02Feb2021, the patient felt as if she was having a heart attack. On 02Feb2021, the patient had trouble breathing, nausea, and severe headache. On 02Feb2021, the patient was felling generally unwell to the point she almost went to the emergency room. The excruciating headache and terribly unwell feeling has lasted well over 10 days. No treatment was received for the events. Outcome of the events was recovering. The patient did not have covid prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Asthma (Asthma under control.); Blood pressure abnormal; Chronic pancreatitis (Occasional chronic pancreatitis); Drug allergy,,,"['Dyspnoea', 'Headache', 'Malaise', 'Nausea']",1,PFIZER\BIONTECH, 1062223,VA,67.0,F,"not thinking straight; very very intense headache; felt an ungodly pressure in my head; My vision was off; foggy; confused; coughing; felt severe tightness in left side of my chest and that moved to the center of my chest and started to like move up higher, more towards my throat and then it stopped; severe tightness in left side of my chest and that moved to the center of my chest and started to like move up higher you know more towards my throat; rapid heart rate, 100bpm and 102bpm and lasted for couple of days.; my head was more clear but still had some pressure and woozy; Trouble concentrating; ALT High; Test: Cholesterol; Result: Little High/Cholesterol 207 was high; This is a spontaneous report from a contactable consumer, the patient. A 67-years-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9269), via an unspecified route of administration on 07Feb2021 (at the age of 67-years-old) as a SINGLE DOSE for Covid-19 Vaccination. Medical history included ongoing asthma, type 2 diabetes mellitus, seasonal allergy (told to take Zyrtec for seasonal allergies prophylactically). Facility in which the vaccine was received was a clinic at a high school through the local hospital. Concomitant medication included fluticasone propionate, salmeterol (WIXELA INHUB), glipizide (GLIPIZIDE). On 07Feb2021, the patient received the first dose and while walking to the observation area (about two minute after receiving the vaccine) the patient experienced very very intense headache, felt an ungodly pressure in my head, vision was off, and trouble concentrating. When she sat down got real foggy, confused and was not thinking straight, was coughing and experienced severe tightness in left side of my chest and that moved to the center of my chest and started to like move up higher, more towards my throat and then it stopped. Patient began taking deep breath. It went back over to left side of my chest and the tightness (stayed in my left chest for probably 3 days but not to the same degree). The fogginess and the intense pressure in my head, it was bad to the point she thought she would not be able to drive home, waiting for 30 minutes, and because she was not thinking clearly she didn't even ask anybody for help. When she got to the car she waited 15 minutes more before driving home. Patient stayed like this for 2 days. When she reached home, she experienced a rapid heart rate, 100bpm and 102bpm and lasted for couple of days. Each day got gradually better, her head was clearer but still had some pressure and woozy. The patient did visit the physician, he did an EKG and other test. The doctor did not think what I had was an anaphylaxis reaction. Physician recommended she make sure to take her inhalers, for asthma and told me to take Zyrtec (for seasonal allergies) ahead of time. Consumer inquired if she should receive the second dose. The patient underwent lab tests and procedures which included blood cholesterol: little high 207 on Feb2021, blood thyroid stimulating hormone: normal on Feb2021, electrocardiogram: normal on Feb2021, full blood count: normal on Feb2021, hemoglobin: 6.9 on Feb2021, heart rate: 100 bpm on Feb2021, heart rate: 102 bpm on Feb2021, metabolic function test: Alt high on Feb2021. No treatment was given for the events. The clinical outcome of the events not thinking straight, pressure in my head, foggy, confused, coughing, tightness in the left side of my chest , it then moved to the center of my chest then moved up towards throat, rapid heart rate, Woozy, intense headache, vision was off and trouble concentrating was recovering while ALT High, and Cholesterol; Result: Little High was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/01/2021,,PVT,WIXELA INHUB; GLIPIZIDE,Asthma,Medical History/Concurrent Conditions: Seasonal allergy ((told to take Zyrtec for seasonal allergies prophylactically).); Type 2 diabetes mellitus,,,"['Alanine aminotransferase increased', 'Blood cholesterol', 'Blood cholesterol increased', 'Blood thyroid stimulating hormone', 'Chest discomfort', 'Confusional state', 'Cough', 'Disturbance in attention', 'Dizziness', 'Electrocardiogram', 'Feeling abnormal', 'Full blood count', 'Haemoglobin', 'Head discomfort', 'Headache', 'Heart rate', 'Heart rate increased', 'Mental impairment', 'Metabolic function test', 'Pain', 'Visual impairment']",1,PFIZER\BIONTECH, 1062224,,,F,"loss of hearing; ear pains; This is a spontaneous report from a contactable consumer, the patient. This female patient of unknown age (reported as (age: 80 unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 25Jan2021 for COVID-19 vaccination. Medical history was not reported. Concomitant medications were not reported. On an unknown date in 2021, the patient had ear pain and loss of hearing. The events were reported as non-serious. The clinical outcome of ear pain and loss of hearing was unknown. The reporter was unsure if the events were related. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,,,UNK,,,,,,"['Deafness', 'Ear pain']",1,PFIZER\BIONTECH, 1062225,IL,70.0,F,"eyelids became puffy; eyes became glassy; fever; body aches; chills; bad headaches; implanted breast skin became blotchy; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E63247) , via an unspecified route of administration in the right arm on 01Feb2021 at 15:00 (at the age of 70-years-old) as a single dose for COVID-19 immunization. Medical history included Raynaud's syndrome, chronic lymphocytic leukaemia, irradiated thyroid gland, high cholesterol, previous breast cancer, allergy to latex and adhesives, and breast implants. Concomitant medications included levothyroxine sodium (SYNTHROID); rosuvastatin (MANUFACTURER UNKNOWN), and unspecified multivitamins. The patient previously took povidone/iodine (BETADINE) on unknown dates for an unknown indication and experienced drug allergy. On 05Feb2021 at 21:00, the patient experienced fever, body aches, chills, bad headaches, and implanted breast skin became blotchy. On 07Feb2021, the patient's eyelids became puffy and eyes became glassy,. All the events were reported as serious for disability. The peak temperature was 101 degrees Fahrenheit on an unknown date in Feb2021. The patient contacted the doctor, eye care professional and hematologist/oncologist for the events. On 08Feb2021, the patient had a COVID-19 nasal swab PCR which was negative. The patient was not treated for the events. The clinical outcome of the fever was recovered on 12Feb2021; while that of the body aches, chills, bad headaches, implanted breast skin became blotchy, eyelids became puffy, and eyes became glassy were recovering.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/01/2021,02/05/2021,4.0,PUB,SYNTHROID; ROSUVASTATIN,,Medical History/Concurrent Conditions: Adhesive tape allergy; Breast cancer; Breast implant user; CLL; High cholesterol; Latex allergy; Raynaud's syndrome; Thyroid disorder,,,"['Body temperature', 'Chills', 'Glassy eyes', 'Headache', 'Pain', 'Pyrexia', 'Rash macular', 'SARS-CoV-2 test', 'Swelling of eyelid']",1,PFIZER\BIONTECH, 1062226,MI,67.0,M,"Bells Palsy; This is a spontaneous report from a contactable consumer (the patient). A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #: EM9810), via an unspecified route of administration, in the right arm (at the age of 67 years) on 09Feb2021 at 10:30 AM at single dose for COVID-19 immunization. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included lisinopril (LISINOPRIL ACTAVIS), rosuvastatin, acetylsalicylic acid (ASPIRIN 81). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Penicillin and experienced rash, Sulphamide and experienced nose bleed. On 10Feb2021 at 08:30 AM, the patient experienced Bell's Palsy. The patient visited the emergency room Therapeutic measures were taken as a result of Bell's Palsy and included tape left eye closed and use wetting gel. The clinical outcome of the bells palsy was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/10/2021,1.0,UNK,LISINOPRIL ACTAVIS [LISINOPRIL]; ROSUVASTATIN; ASPIRIN 81,,,,,['Facial paralysis'],1,PFIZER\BIONTECH, 1062227,CA,,F,"atrial fibrillation episode; This is a spontaneous report from a contactable consumer, the patient, from the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included heart problem and tachycardia. Concomitant medications included metoprolol succinate (MANUFACTURER UNKNOWN) for heart problem and tachycardia from an unknown date and unknown if ongoing. On an unknown date, 6 days after the first dose, the patient experienced atrial fibrillation episode which required hospitalization for a few days. The patient mentioned her medication was going to be changed to sotalol (MANUFACTURER UNKNOWN) due to the event (unspecified if treatment started). The clinical outcome of the atrial fibrillation episode was unknown. The patient also mentioned that nobody thought her experience was related to the Pfizer vaccine. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The event atrial fibrillation episodes is attributed to an underlying medical condition and assessed unrelate to BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE0.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,METOPROLOL SUCCINATE,,Medical History/Concurrent Conditions: Heart disorder; Tachycardia,,,['Atrial fibrillation'],1,PFIZER\BIONTECH, 1062228,CA,,M,"Tested positive after the first dose; Tested positive after the first dose; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A male patient of an unspecified age received 1st dose of BNT162B2 (Pfizer/BioNTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive after the first dose on an unspecified date. The patient underwent lab tests and procedures which included Covid test: positive on an unspecified date. The outcome of event was unknown. Information about batch/lot number requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1062229,,,U,"tested positive for covid virus after first dose vaccine; tested positive for covid virus after first dose vaccine; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. A patient of unspecified age and gender received 1st dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was tested positive for covid virus after first dose vaccine. The patient underwent lab tests and procedures which included covid virus test: positive on an unspecified date. The outcome of event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1062230,NJ,30.0,F,"whole body felt sore and exhausted; whole body felt sore and exhausted; bad cold/flu; bad cold/flu; little chest pain; minor fever; blood pressure dropped; dizziness; backpain; left arm felt sore; sleepy/light drowsiness; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on the left arm on 11Feb2021 15:30 at a single dose (at the age of 30-years-old) for COVID-19 immunization. Medical history included >13 years ago: diagnosed TB with no symptom, completed TB treatment 1 year-plan and has issue no since then; >16 years ago: Hepatitis-b positive but received treatment and cleared out on diagnostics afterward. The patient was not pregnant. Concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient has no known allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 21Jan2021 at 13:15 on the left arm at a single dose (at the age of 30-years-old) for COVID-19 immunization. After about 4.5h post-vaccination (20:00), her left arm felt sore and within the next 3h, she felt sleepy and experienced random light drowsiness. She woke up around 06:30 the next day (12Feb2021) only felt continued sore arm. However, at 08:30 to 09:30, her whole body felt sore and exhausted, especially back pain, as if she having a bad cold/flu. She also felt a little chest pain, had a minor fever and went sleeping from 12:00, woke up around 18:00-19:00. The whole body ache was almost gone but her back was still in pain and her blood pressure dropped with random dizziness when she was walking or standing up. The next morning (13Feb2021), the back pain was gone and she felt it back to normal except for a little random dizziness in movement. She did not take any medication to alleviate the adverse effects during the timeline. The patient was not COVID tested post vaccination. The patient recovered from back pain in 13Feb2021, the patient recovered from the remaining events in Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Hepatitis B antibody positive (>16 years ago: Hepatitis-b positive but received treatment and cleared out on diagnostics afterward.); TB (>13 years ago: completed TB treatment 1 year-plan and has issue no since then),,,"['Back pain', 'Blood pressure decreased', 'Blood pressure measurement', 'Chest pain', 'Dizziness', 'Fatigue', 'Influenza', 'Nasopharyngitis', 'Pain', 'Pain in extremity', 'Pyrexia', 'Somnolence']",2,PFIZER\BIONTECH, 1062231,OH,67.0,F,"Achy right arm (site of injection) about 12 hours after injection; achy muscles all over body; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EM9809), via an unspecified route of administration on 13Feb2021 10:00 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant at the time of vaccination. The facility type vaccine was Pharmacy or Drug Store. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. None medical history. Concomitant medication included omeprazole, fexofenadine hydrochloride (ALLEGRA). The patient experienced achy right arm (site of injection) about 12 hours after injection on 13Feb2021 21:30; achy muscles all over body about 16 hours after injection on 13Feb2021. Pain was relieved by taking two naproxen tablets. The outcome of events was recovered in Feb2021. The events were reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/13/2021,0.0,PHM,OMEPRAZOLE; ALLEGRA,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Myalgia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1062232,CA,64.0,F,"Headache; left arm is hurting from the shoulder; tired; Nauseous; injection site pain; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration at arm left on 09Feb2021 at 14:10 (at the age of 64 years) at single dose for COVID-19 immunization. Medical history included ongoing Crohn's disease, ongoing allergies, ongoing blood cholesterol abnormal. Concomitant medication included mesalamine (strength: 400 mg) oral at 400 mg twice daily for Crohn's disease, atorvastatin oral at 400 mg once a day for blood cholesterol abnormal, azathioprine oral at 50 mg twice daily for Crohn's disease, cetirizine oral at 10 mg for allergies, vitamin D at 1000 iU daily for supplementation, ketotifen fumarate (strength: 0.025 %) ophthalmic twice daily for allergies and ipratropium bromide (strength: 0.06%) nasal daily for allergies, all from an unknown date and ongoing. The patient experienced sore at the injection site on 09Feb2021, headache on the left side and her left arm was hurting from the shoulder down and she feels really tired and nauseous, all on 12Feb2021. The patient outcome of injection site pain was recovered on 09Feb2021; the outcome of the other events was not recovered. The information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/09/2021,0.0,UNK,MESALAMINE; ATORVASTATIN; AZATHIOPRINE; CETIRIZINE; VITAMIN D [VITAMIN D NOS]; KETOTIFEN FUMARATE; IPRATROPIUM BROMIDE,Allergy; Blood cholesterol abnormal; Crohn's disease,,,,"['Fatigue', 'Headache', 'Nausea', 'Pain in extremity', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1062233,,,F,"touch of pneumonia; running a fever/temperature; running a fever/temperature; This is a spontaneous report from a contactable consumer (child of patient). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunisation. Medical history included Alzheimer's. The patient's concomitant medications were not reported. The patient experienced running a fever/temperature and a touch of pneumonia on 11Feb2021. The clinical course was reported as follows: The day the patient was to go for her second dose, she was running a fever and was not able to go. The patient was diagnosed and had a touch of pneumonia. The patient was put on unspecified steroids and two unspecified antibiotics. The patient was running a temperature on an unspecified date but was better on 12Feb2021. Therapeutic measures were taken as a result of the events as aforementioned. The clinical outcome of running a fever and a touch of pneumonia was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,02/11/2021,,UNK,,,Medical History/Concurrent Conditions: Alzheimer's disease,,,"['Body temperature', 'Body temperature increased', 'Pneumonia', 'Pyrexia']",1,PFIZER\BIONTECH, 1062234,CT,,U,"Large lymph node swelling on left side of neck; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced large lymph node swelling on left side of neck after use of product. Shot was in the left. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Lymphadenopathy'],UNK,PFIZER\BIONTECH, 1062235,MI,41.0,F,"Bell's palsy; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9269/expiration date: not provided), via an unspecified route of administration, on 04Feb2021 08:30 (at the age of 41 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included attention deficit hyperactivity disorder (ADHD). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK9231/expiration date: not provided), via an unspecified route of administration, on 14Jan2021 at 08:45 (at the age of 41 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021, the patient experienced Bell's~ palsy. The event resulted in an emergency room/department or urgent care visit and received treatment which included CT scan, EKG, blood tests, and steroid prescribed. The outcome of the event Bell's palsy was not recovered. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Bell's palsy due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI and viral serology, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/10/2021,6.0,UNK,ADDERALL,,Medical History/Concurrent Conditions: ADHD,,,"['Blood test', 'Computerised tomogram', 'Electrocardiogram', 'Facial paralysis']",2,PFIZER\BIONTECH, 1062236,,,U,"Reaction to Guillain-Barre Syndrome; This is a spontaneous report from a non-contactable consumer (the patient) from a Pfizer-sponsored program . A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported reaction to Guillain-Barre Syndrome (no other details provided). The clinical outcome of reaction to Guillain-Barre Syndrome was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Guillain-Barre syndrome'],UNK,PFIZER\BIONTECH, 1062237,OH,81.0,F,"she had symptoms of a stroke; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) first dose, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Initially, it was reported that the patient experienced symptoms of Bell's palsy before getting the second dose. It was further reported that the patient stated it was not true that she experienced Bell's palsy. She mentioned she had symptoms of a stroke on an unspecified date. She wanted to confirm that her appointment for next 20Feb2021 has not been cancelled. Consumer refused to continue with the survey. The outcome of the event was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Cerebrovascular accident'],1,PFIZER\BIONTECH, 1062238,MD,82.0,F,"Increased blood pressure; Pain breathing; felt some discomfort in her hand; This is a spontaneous report from a contactable Physician. A 82-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 08Feb2021 at 0.3 mL, single for Covid-19 immunisation . Medical history included ongoing cardiac disorder (she has had five bypasses ten years ago) , ongoing lung disorder, ongoing osteoporosis , she has had three operations on her spinal cord. She has a neurologic compression fracture from ages ago , seasonal allergy, nitrate compound therapy, hypertension, anticoagulant therapy, electrolyte imbalance. Concomitant medication included ranolazine (RANEXA), isosorbide (ISOSORBIDE), gliclazide (DIAZIDE [GLICLAZIDE]), apixaban (ELIQUIS), magnesium (MAGNESIUM) , ubidecarenone (Q-10 CO-ENZYME). The patient experienced increased blood pressure on 09Feb2021 with outcome of not recovered , pain breathing on 09Feb2021 with outcome of not recovered , felt some discomfort in her hand on 09Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: increased on 09Feb2021 166/100 and pulse 65. The 100 was alarming to her. The patient would notice the increase in blood pressure and pain breathing when walking longer distances Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/09/2021,1.0,PVT,RANEXA; ISOSORBIDE; DIAZIDE [GLICLAZIDE]; ELIQUIS; MAGNESIUM; Q-10 CO-ENZYME,Cardiac disorder (Stated she has had five bypasses; this was ten years ago./cardiac issues); Osteoporosis (Verbatim: Osteoporosis); Pulmonary disorder (Verbatim: Pulmonary problems),Medical History/Concurrent Conditions: Anticoagulant therapy; Electrolyte imbalance; Hypertension; Nitroglycerine therapy; Seasonal allergy; Surgery (She has had three operations on her spinal cord.),,,"['Blood pressure increased', 'Blood pressure measurement', 'Limb discomfort', 'Painful respiration']",1,PFIZER\BIONTECH, 1062239,SC,72.0,F,"Passed out; Constant running nose; Cough; bad cough; Sore throat; Diarrhea; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received the second of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL9267, Expiration Date May2021, via an unspecified route of administration on 08Feb2021 (at the age of 72 years old) as SINGLE DOSE in the left arm for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Historical information included BNT162B2 dose 1 for COVID-19 vaccination.The patient developed the sore throat on 09Feb2021, Cough; bad cough on 10Feb2021, constant running nose on 11Feb2021. On 11Feb2021, the patient passed out in the bathroom floor, had an ambulance here. Patient still coughing a little, not as badly. The patient experienced diarrhea in Feb2021. Treatment for all events included cetirizine (ZYRTEC), Triamcinolone (NASACORT), pseudoephedrine (SUDAFED), dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL). Outcome of the events Passed out, Sore throat, Constant running nose, Diarrhea was unknown. Outcome of the events Cough; bad cough was not recovered",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/01/2021,,UNK,,,,,,"['Cough', 'Diarrhoea', 'Loss of consciousness', 'Oropharyngeal pain', 'Rhinorrhoea']",2,PFIZER\BIONTECH, 1062240,MA,,M,"chills; slight fever; flu like symptoms; minor headache; slight aching limbs; mild fatigue; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: el3247), via an unspecified route of administration on 15Feb2021 11:45 at a single dose on left arm for COVID-19 immunization. The patient's medical history was not reported. The patient has no allergies to medications, food or other products. Concomitant medication included fluticasone propionate (FLOVENT). The patient previously received first dose of BNT162B2 on 26Jan2021 for COVID-19 immunization (lot number: el3247, administration time: 11:00 AM, vaccine location: left arm, dose number: 1). The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. On 15Feb2021 23:00, the patient experienced chills, slight fever, slight aching limbs, minor headache (would describe as flu like symptoms) occurred 10 hours post injection with mild fatigue during course of following day. The events were reported as non-serious. No treatment was received for the adverse events. The patient was recovering from the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/15/2021,0.0,WRK,FLOVENT,,,,,"['Chills', 'Fatigue', 'Headache', 'Influenza like illness', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH, 1062241,,,F,"arm soreness; more discomfort than I usually have for vaccine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 73; Unit: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization and apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date at an unknown dose and frequency as blood thinner. The patient medical history and concomitant medications were not reported. It was reported that the patient got her first dose of BNT162B2 and experience arm soreness on the second day, more discomfort than she usually have for vaccine. By the third day, the patient was fine, and reported that ""it went away"". The patient stated that ""they have to give me a 2nd shot, right? since I'm on a blood thinner"". The outcome of the events was recovered on an unspecified date. The action taken in response to the events for apixaban was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,Eliquis,,,,,"['Discomfort', 'Pain in extremity']",1,PFIZER\BIONTECH, 1062242,IN,,U,"patient got Covid after the first dose of the vaccine; patient got Covid after the first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support from a contactable Nurse reporting for a patient. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date the patient got Covid after the first dose of the vaccine. The reporter was inquiring how long the patient should wait before getting a second dose. The clinical outcome of the patient got Covid after the first dose of the vaccine was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1062243,GA,,F,"BP 225/109; heart rate 52; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date: Not available/provided by the reporter at the time of report) via an unspecified route of administration on 10Feb2021 (Wednesday) at single dose for Covid-19 immunization. The patient is vaccinated in a hospital. Medical history included that the patient does have a history of high blood pressure and takes clonidine twice a day. The patient previously took first dose of bnt162b2 on unspecified date at the hospital for covid-19 immunization; and previously took clonidine on unspecified date for high blood pressure. It was reported that late on 11Feb2021 she texted her symptoms, BP 225/109, heart rate 52 and temp. 99.1. She had notified her doctor who gave her instructions to help her BP. The events took place after use of product. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Yes,Not Reported,,Not Reported,U,02/10/2021,02/11/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure high (She does have a history of high blood pressure and takes clonidine twice a day.),,,"['Blood pressure increased', 'Blood pressure measurement', 'Body temperature', 'Heart rate', 'Heart rate decreased']",2,PFIZER\BIONTECH, 1062244,KS,,M,"received first dose of the covid-19 vaccine on 27Jan2021, he tested positive for covid-19 on 05Feb2021; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. This male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 27Jan2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that received first dose of the covid-19 vaccine on 27Jan2021, he tested positive for covid-19 on 05Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Feb2021, sars-cov-2 test: positive on 11Feb2021 (He went again yesterday to be tested and tested positive). He asked if he should receive the second dose of the vaccine next Wednesday. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,02/05/2021,9.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1062245,KS,78.0,M,"Bell's Palsy caused the side of my face to swell up and droop on one side; Eyes have been bothering him and he is blinking; Can't talk very good because his lips are swelled up/hard to talk; This is a spontaneous report from a contactable consumer reporting for himself. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EM9809/expiration date: not provided), via intramuscular route of administration, on 04-FEB-2021 at 14:30 (at the age of 78 years old) 0.3mL as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included patient was diabetic since an unknown date and has psoriatic arthritis. Concomitant medication included infliximab (REMICADE) infusion every 8 weeks for psoriatic arthritis and cetirizine hydrochloride (EQUATE ALLERGY RELIEF). The patient had infliximab infusion the morning of 04Feb2021, prior to receiving the vaccination and was told that infliximab would not be a problem with receiving the vaccination on the same day. On 07Feb2021, the patient went to the emergency room due to Bell's palsy, which was described as swelling of lips, nose, mouth, and side of face and stated that he can't talk very good because his lips are swelled up/hard to talk and his eyes have been bothering him and he is blinking. The patient stated, ""I went to the emergency room at a hospital and what they said is totally unrelated to the COVID shot I got. In the meantime, few days after I had the shot, I had somehow got Bell's palsy caused the side of my face to swell up and droop on one side. I just wanted to get back to you so you knew that was not some reaction to the COVID shot, it was something else."" Treatment for the event Bell's palsy included took Allergy Relief Equate 25mg ultra tablet and another allergy pill and it did not help swelling of lips, nose, mouth, and side of face. Relevant tests included blood work on an unspecified date in 2021 ""two weeks ago"" that was all good. The outcome of the events Bell's palsy, eyes have been bothering him and he is blinking and hard to talk was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bell's palsy cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/07/2021,3.0,UNK,REMICADE,,Medical History/Concurrent Conditions: Diabetic; Psoriatic arthritis,,,"['Blood test', 'Facial paralysis', 'Ocular discomfort', 'Speech disorder']",1,PFIZER\BIONTECH,OT 1062246,,,F,"cognitive issue (dementia); This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 05Feb2021, at a single dose, for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced cognitive issue (dementia). The patient wanted to know about her second dose schedule. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/01/2021,,UNK,,,,,,['Dementia'],1,PFIZER\BIONTECH, 1062247,ME,,F,"was admitted in the hospital last Friday morning for Pneumonia; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support from a contactable consumer. This female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on an unknown date for COVID-19 vaccination. Medical history includes unspecified underlying conditions. The patient was on unspecified concomitant medications. On an unknown date, the patient had pneumonia and was admitted to the hospital on 05Feb2021. The patient is on oxygen at night while asleep. The clinical outcome of pneumonia was unknown. The reporter doubts if it is related to the Pfizer vaccine The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The event pneumonia more likely represent an intercurrent medical condition which was not related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE).",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,['Pneumonia'],1,PFIZER\BIONTECH, 1062248,NY,,M,"dizziness; This is a spontaneous report from a Pfizer-sponsored program Covax US Support, received from a contactable consumer (patient's daughter). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 04Feb2021 as a SINGLE DOSE for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced horrible dizziness on 08Feb2021 that resulted in being hospitalized on unknown date. Outcome of the event was unknown. Information on batch/lot number was requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/04/2021,02/08/2021,4.0,UNK,,,,,,['Dizziness'],1,PFIZER\BIONTECH, 1062249,NC,,M,"Passed out; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications were not reported. On an unspecified date, the patient experienced: passed out (hospitalization, medically significant). The patient's mother called-in on-behalf of her son who passed out in a restaurant and was taken into the hospital due to this emergency. The patient's mother was worried saying that her son was due for the second dose of the COVID-19 vaccine. The patient's mother was unable to identify when her son received the first shot of the vaccine. The patient's mother was also unable to identify why her son passed out. The mother's concern was that her son already missed the second dose. The clinical outcome of the event, passed out, was unknown. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,['Loss of consciousness'],UNK,PFIZER\BIONTECH, 1062250,VA,,F,"Diagnosed with cellulitis; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was diagnosed with cellulitis on an unspecified date. Therapeutic measures were taken as a result of the event and included treatment with KEFLEX for 10 days. The patient outcome of the event was unknown. The information on the batch number has been requested.; Sender's Comments: The information currently available is limited and does not allow a meaningful case assessment. Based solely on an implied temporal association causality between event cellulitis and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Cellulitis'],UNK,PFIZER\BIONTECH, 1062251,CA,76.0,M,"Fever; belly is swollen; hurting; hard for him to breath/moves and exerts, his breathing is labored; extremely tired; muscle pain, aches; extreme chills/shivering; shaking; Joint pain; This is a spontaneous report from a contactable consumer. A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: EL3248, expiry date not reported), via an unspecified route of administration on 02Feb2021 11:00 at a single dose in the left arm for COVID-19 immunization. Medical history included ongoing atrial fibrillation (reported he has had no occurrence for 3-4 years); and high blood pressure and high cholesterol, both from an unknown date and unknown if ongoing; and pneumonia. Concomitant medications included that patient was also taking high blood pressure medication and high cholesterol medication. When asking for the Lot number, reporter explained ""his card was in his wallet but she gave her lot and said it was the same, they got the shot at the same time, within 5 minutes of each other"". Patient previously took amoxicillin for pneumonia from 09Jan2021 to 13Jan2021, reported as he took this for 5 days and stopped. This was reported as ""It was noted that he had pneumonia and got an antibiotic that he took for 5 days. It was amoxicillin and was started on 09Jan2021"" (pending clarification). Reporter also stated that she was not sure if it was a Pfizer vaccine but patient did have a mild reaction to the first shingles vaccine (unspecified) but this lasted only 24 hours. Reporter, a wife calling for her husband (patient), was reporting on the COVID vaccine and who explained he was having symptoms and wanted to report this but also has a question on what to do. Patient was extremely tired. This was noticed on the 3rd day after the shot. This would be Friday 05Feb2021 and it was the same since starting. There were moments when he has rested and showered where he felt better but then it went down again. The patient had muscle pain, aches on 05Feb2021, this would be Friday, and it came and went but was about the same. Patient had extreme chills on 05Feb2021, and he was still shaking now (05Feb2021). It was a little better during the day, maybe because he was moving around but last night he was shivering and shaking for 3 hours and she could not get him warm even with the heating pad. Patient also had joint pain on 05Feb2021 and it was the same since starting. Patient had fever that probably started Sunday, 07Feb2021 wherein few hours ago, it was 102.00 but she got it down to about 100.2 now, it has increased and was the reason she called today. Patient's belly was swollen since 05Feb2021 and it was the same since starting. She remarked she was not sure if this was where lymph nodes were or not and the cause of the swelling. It was also explained that due to hurting, it was hard for him to breath. When he moved and exerted, his breathing was labored. This would be Friday, 05Feb2021 and it is the same since starting. Yesterday, patient went to his primary doctor. He was supposed to do blood work but couldn't due to his fever. The doctor prescribed him an anti-inflammatory called Etodolac 500mg. It was by Taro Pharmacutal US (there was no Lot or expiry). He took one at 7pm and was to take them twice a day, took another a little while ago. Reporter explained she has heard stories where the second dose is worse, and wanted to know if that is true. She also wanted to know if the product Etodolac, has side effects that are similar to what patient was experiencing, and wouldn't taking that make the side effects double worse. Therapeutic measures were taken as a result of the events extreme chills/shivering, shaking, joint pain, and fever. The events extremely tired, muscle pain, aches, extreme chills, shaking, joint pain, fever, belly was swollen, hurting, and ""hard for him to breath/moved and exerted, his breathing was labored"" were not recovered",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/05/2021,3.0,PVT,,Atrial fibrillation (no occurrence for 3-4 years),Medical History/Concurrent Conditions: Adverse reaction (to the first shingles vaccine); Blood pressure high; High cholesterol; Pneumonia,,,"['Abdominal distension', 'Arthralgia', 'Body temperature', 'Chills', 'Dyspnoea exertional', 'Fatigue', 'Myalgia', 'Pain', 'Pyrexia', 'Tremor']",1,PFIZER\BIONTECH, 1062252,VA,46.0,F,"Mental fog; Massive head consuming headache; Extreme fatigue; This is a spontaneous report from a contactable other hcp. A 46-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9264), via an unspecified route of administration arm right single dose on 05Feb2021 for COVID-19 immunisation. First dose lot#EL8982, arm right (IM) was received on 15Jan2021, 10:00. Medical history included drug hypersensitivity (to sulfa drugs) from an unknown date. The patient's concomitant medications were not reported. The patient experienced mental fog on 05Feb2021 15:00, massive head consuming headache on 05Feb2021 15:00, extreme fatigue on 05Feb2021 15:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 12Feb2021. The events outcome was recovered in Feb2021 No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the information currently available, a causal relationship between event ""mental fog"" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,SEN,,,Medical History/Concurrent Conditions: Drug hypersensitivity (to sulfa drugs),,,"['Fatigue', 'Headache', 'Mental impairment', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1062253,,72.0,F,"Shingles; This is a spontaneous report from a non-contactable non-healthcare professional reporting for a patient. A 72-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 (at the age of 72-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 post vaccination by nasal swab on 09Feb2021 which had negative results. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 10Feb2021, the patient experienced shingles. The patient was hospitalized for the event on an unknown date for 2 days. It was unknown if the patient received treatment. The clinical outcome of the event shingles was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/20/2021,02/10/2021,21.0,UNK,,,,,,"['Herpes zoster', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1062254,ME,60.0,F,"pain in lymphoma area; pain in lymphoma area; Multiple headaches; neck pain; inner ear pressure; jaw pain; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included type 2 diabetes and overweight, and the patient had no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications included lisinopril, metformin, metoprolol, sitagliptin (JANUVIA). The patient did not receive any other vaccine within 4 weeks of the vaccination. On 01Feb2021 at 09:00, the patient experienced multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcomes of multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain was resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,02/01/2021,11.0,UNK,LISINOPRIL; METFORMIN; METOPROLOL; JANUVIA [SITAGLIPTIN],,Medical History/Concurrent Conditions: Overweight; Type 2 diabetes mellitus,,,"['Ear discomfort', 'Headache', 'Lymphoma', 'Neck pain', 'Pain', 'Pain in jaw']",1,PFIZER\BIONTECH, 1062258,NY,53.0,F,"Lost 100% of vision in left eye and 50% of vision in right eye; Numbness of face and neck; Numbness of face and neck; Swelling of face and neck; Swelling of face and neck; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech, lot number EN6201), via an unspecified route of administration in right arm, on 10Feb2021 at 15:45, at single dose, for COVID-19 immunisation. Medical history included blood cholesterol increased. Patient did not have known allergies, did not have COVID-19 prior to vaccination and was not pregnant at time of events or vaccination. There were no concomitant medications. Patient did not receive other different vaccines in four weeks. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech, lot# EL3244), in arm left, on 20Jan2021 at 15:45, for COVID-19 immunisation. The patient experienced lost 100% of vision in left eye and 50% of vision in right eye on 10Feb2021 at 17:30 with outcome of recovered on 11Feb2021 at 07:30 (after 14 hours), numbness of face and neck on 10Feb2021 at 17:30 with outcome of recovered on 12Feb2021 at 09:30 (after 40 hours), swelling of face and neck on 10Feb2021 at 17:30 with outcome of recovered on 12Feb2021 at 09:30 (after 40 hours). Patient did not tested positive for COVID-19 after vaccination. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/10/2021,0.0,UNK,,,Medical History/Concurrent Conditions: High cholesterol,,,"['Blindness transient', 'Hypoaesthesia', 'Swelling', 'Swelling face']",2,PFIZER\BIONTECH, 1062260,NY,99.0,F,"Developed acute facial droop and slurred speech 2h after 1st dose of the vaccine on 2/17, found with R MCA stroke. Then became unresponsive on 2/27 and was found with an acute L MCA stroke. Was transferred from another hospital, was not a candidate for intervention, and was made comfort and died on 2/28",Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,PVT,warfarin,,"hypotension, HLD, permanent AF on warfarin, thyroiditis, TIA",,none,"['Cerebrovascular accident', 'Death', 'Dysarthria', 'Facial paralysis', 'Unresponsive to stimuli']",UNK,PFIZER\BIONTECH, 1062262,GA,78.0,M,"Experiencing extreme itching on site of vaccine.; This is a spontaneous report from a contactable consumer reported for himself. A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot # EN6201, via unknown route at left arm on 18Feb2021 at 12:15 (at the age of 78-year-old) at single dose for covid-19 immunization. The patient received the first dose of the same vaccine on 28Jan2021 at 12:15 AM at the left arm from lot # EL3248. The patient experienced extreme itching on site of vaccine. The outcome of the event was not recovered. No COVID prior vaccination. Patient has not been tested for COVID-19. Adverse event result in hospitalization, Life threatening illness, Disability or permanent damage, Congenital anomaly.",Not Reported,,Yes,Not Reported,,Yes,N,02/18/2021,,,PVT,,,,,,['Vaccination site pruritus'],2,PFIZER\BIONTECH, 1062263,,,F,"Thrombocytopenia; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced thrombocytopenia. Hospitalization required. Clinical outcome of the adverse event was unknown at time of this report. No follow-up attempts are possible, information about lot number cannot be obtained.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,['Thrombocytopenia'],UNK,PFIZER\BIONTECH, 1062264,CO,21.0,F,"Patient fainted and hyporesponsive.; Patient fainted and hyporesponsive.; This is a spontaneous report from a non-contactable other healthcare professional. A 21-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: En9265, intramuscular on 13Feb2021 at 14:00 (at the age of 21 years old) as a single dose in the right arm for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient fainted and was hyporesponsive on 13Feb2021. The patient did not receive treatment for the events. The outcome of the events was recovered in Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between events fainted and was hyporesponsive and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/13/2021,0.0,SEN,,,,,,"['Hyporesponsive to stimuli', 'Syncope']",1,PFIZER\BIONTECH,OT 1062265,ID,86.0,F,"left arm painful; This is a spontaneous report from a contactable nurse (patient). An 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9265), via an unspecified route of administration in the left arm, on 03Feb2021 at 12:05 (at the age of 86-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient had no family history related to the adverse events. The patient had no prior adverse events to vaccinations nor any prior vaccinations within four weeks of vaccination. There were no additional vaccines administered on the same day. The patient experienced left arm painful on 06Feb2021, which was reported with disability. The clinical course was reported as follows: The first 3-4 days (as reported), there were no side effects; however, her arm was painful for days 5- 7, and on day 9, it was still a little sore but better. Therapeutic measures were taken as a result of the event, which included a visit to the chiropractor. The clinical outcome of left arm painful was recovering. The primary reporter (patient) assessed the causality between the event and the suspect product as related.; Sender's Comments: Based on the information available, a causal relationship between event ""left arm painful"" and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/03/2021,02/06/2021,3.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1062266,TX,63.0,F,"preseptal cellulitis eyelid; hurt her back, aggravating the back pain; hurt her back, aggravating the back pain; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9261), via an unspecified route of administration in the right arm on 20Jan2021 at 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunization. Medical history included breast cancer from 2015, back pain (which predated vaccination with BNT162B2), cholesterol, diabetes, blood pressure, kidney stones, vitamin D low, allergy, depression, lichen sclerosus and hair loss. Ongoing concomitant medications included simvastatin for cholesterol, empagliflozin (JARDIANCE) for diabetes, metformin for diabetes from 20Dec2020, linagliptin (TRADJENTA) for diabetes, hydrochlorothiazide/valsartan for blood pressure, potassium citrate (UROCIT-K) for kidney stones, vitamin D for vitamin D low, fexofenadine hydrochloride (ALLEGRA) for allergy, anastrozole (ARIMIDEX) for depression, clobetasol propionate for lichen sclerosus, lidocaine hydrochloride (ASPERCREME WITH LIDOCAINE) for back pain, minoxidil for hair loss. There were no additional vaccines administered on the same date as BNT162B2, and no vaccinations within 4 weeks prior of BNT162B2. On 06Feb2021, the patient hurt her back, aggravating the back pain. On 06Feb2021, the patient experienced preseptal cellulitis of the eye lid. The events required a visit to the emergency room and physician office but did not require admission to the hospital. The patient went to the doctor on 06Feb2021 for preseptal cellulitis of the eyelid and was treated with cephalexin 250 mg orally four times a day from 06Feb2021 to 11Feb2021, and dexamethasone/neomycin/ polymyxin b (NEOPOLYDEX) from 06Feb2021 and ongoing three times per day. On 08Feb2021, the patient took paracetamol (TYLENOL) 500 mg for the back pain. The patient went to the doctor for the back pain on 11Feb2021 and was prescribed meloxicam 15 mg once daily and cyclobenzaprine 10 mg, (take one half by mouth as needed). Reportedly, the cyclobenzaprine did absolutely nothing. The patient also took paracetamol (TYLENOL ARTHRITIS) 650 mg per her doctor's recommendation. The clinical outcome of preseptal cellulitis eyelid was resolving, and of ""hurt her back, aggravating the back pain"" was not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,02/06/2021,17.0,UNK,SIMVASTATIN; JARDIANCE; METFORMIN; TRADJENTA; VALSARTAN HYDROCHLOROTHIAZIDE KRKA; UROCIT-K; VITAMIN D [VITAMIN D NOS]; ALLEGRA; ARIMIDEX; CLOBETASOL PROPIONATE; ASPERCREME WITH LIDOCAINE; MINOXIDIL,,Medical History/Concurrent Conditions: Allergy; Back pain (predates treatment with the Pfizer COVID 19 vaccine); Blood cholesterol abnormal; Blood pressure abnormal; Breast cancer; Depression; Diabetes; Hair loss; Kidney stones; Lichen sclerosus; Vitamin D low,,,"['Back injury', 'Back pain', 'Periorbital cellulitis']",1,PFIZER\BIONTECH, 1062267,TX,,F,"H.pylori infection; had a really bad headache; sore left arm / hurt and ached all the way down and when trying to open it hurt / could only lay on her back and not her side because it hurt; Chills; she hardly slept all night; She can hardly raise her left arm; has a big bump to left arm; quarter size red area and redness all around the area to left arm; This is a spontaneous report from a contactable consumer (patient). This 55-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date at 15:00, for COVID-19 immunization. The first BNT162B2 vaccine dose was given on an unknown date. Medical history included ongoing hypertension; she was taking two unspecified medications already. The day following vaccination, the patient experienced a really bad headache, arm sore and chills. She left work, went home and felt like she started to feel better. She hardly slept all night and her left arm hurt and ached all the way down and when trying to open it hurt. She can hardly raise her left arm, it hurt so bad. On left arm she had a big bump and quarter size red area and redness all around the area. She was having headache again. She could only lay on her back and not her side because it hurt. At 3:30 she took paracetamol (TYLENOL) and that took the edge off. On an unspecified date in Feb2021 she was diagnosed with H. pylori infection and had been on an antibiotic. She took ibuprofen (ADVIL) at about 8:30 and put heating pad on her arm. She was regretting the vaccine because she did not know that it would be this bad. Events outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,Hypertension (she was taking two unspecified medications already),,,,"['Chills', 'Erythema', 'Headache', 'Helicobacter infection', 'Insomnia', 'Mobility decreased', 'Pain in extremity', 'Skin disorder']",UNK,PFIZER\BIONTECH, 1062334,,,F,"tingling in arms; tingling in lips; pain that went down her whole arm; arm feels painful and she can't move it; has been hurting all day; red ring around injection site; A spontaneous report from was received from a Reporter concerning a unknown year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like Paraesthesia, Oral Paraesthesia, Limb discomfort, injection site erythema. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, after receiving the dose of Moderna COVID vaccine (mRNA-1273) (lot/batch: unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection. On date or an unknown date, The patient experienced tingling in the arms, tingling in lips, pain that went down her whole arm, arm hurting, red ring around her injection site, and painful arm which can't be moved. Treatment included diphenhydramine hydrochloride and two steroids for her symptoms, which subsided. Action taken with mRNA-1273 in response to the events was reported. On date 5 January 2021 the outcome of the events like pain in extremity, limb discomfort, injection site erythema are unkown.; Reporter's Comments: This case concerns a female of unknown age who had serious unexpected events of tingling of extremity, oral paraesthesia, and pain in extremity, NS unexpected arm discomfort, and NS expected injection site erythema. Event onset 15 minutes after first dose of mRNA-1273. Treated with Benadryl and steroids. Events subsided. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,,01/05/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Injection site erythema', 'Limb discomfort', 'Pain in extremity', 'Paraesthesia', 'Paraesthesia oral']",1,MODERNA, 1062335,ID,53.0,F,"Lymph nodes swelled up; Couldn't breathe; Diarrhea; Stomach hurt; Profusely sweat; Arm was sore; Fatigue; Chills; Fever; Headache; Teeth chattering; Joints hurt; Coughing; Chest tightness; Back hurt; Got so sick; A spontaneous report (United States) was received from a consumer, a 53-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273), and who experienced lymph nodes swelled up (lymphadenopathy), couldn't breathe (dyspnoea), chest tightness (chest discomfort), got so sick (illness), arm was sore (pain in extremity), headache, fever (pyrexia), chills, fatigue, teeth chattering (chills), coughing (cough), joints hurt (arthralgia), profusely sweat (hyperhidrosis), back hurt (back pain), diarrhea (diarrhoea), and stomach hurt (stomach pain). The patient's medical history was not reported. Concomitant product use was not provided by the reporter. On 16 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Around 6:30 pm on the same day, the patient's arm was sore. She also started getting a headache, fever up to 103 Fahrenheit (F), and chills. She got ""so sick, she couldn't breathe"", so she used her continuous positive airway pressure machine (CPAP), but it didn't help. She felt fatigued and was coughing. Her joints hurt that night until the next day. Her teeth were chattering until the next day. She had a fever and started to profusely sweat for a couple of hours. She had chest tightness and her back hurt. On 17 Jan 2021, her temperature was 95 F. On 18 Jan 2021, the patient's stomach hurt and stopped later that day. The she had diarrhea. On 19 Jan 2021, she reported that she still had a temperature of 95 F, coughing, fatigue, arm soreness, diarrhea, chest tightness, and back pain. On 20 Jan 2021, the patient's lymph nodes swelled up and she was having difficulty breathing. She went to an urgent care and from there she was ""sent/admitted"" to the hospital. No treatment information was provided. The events, teeth chattering and arthralgia, profusely sweat, were considered resolved on 17 Jan 2021. The event, stomach hurt, resolved on 18 Jan 2021. The events, chest tightness, arm was sore, fever, fatigue, coughing, diarrhea, back hurt, were considered not resolved. The events, lymph nodes swelled up, couldn't breathe, headache, chills, got so sick, were considered unknown.; Reporter's Comments: This case concerns a 53-year-old female with serious unexpected lymphadenopathy and dyspnea and NS unexpected cough, chest tightness, arm pain, back pain, stomach pain, sickness, diarrhea, hyperhidrosis and NS expected headache, fatigue, fever, chills, teeth chattering, arthralgia. Event onset the same day as first dose mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/16/2021,01/16/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Abdominal pain upper', 'Arthralgia', 'Back pain', 'Body temperature', 'Chest discomfort', 'Chills', 'Cough', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Illness', 'Lymphadenopathy', 'Pain in extremity', 'Pyrexia']",1,MODERNA,OT 1062336,FL,31.0,F,"200/100 high blood pressure; stammering problems; uncontrolled shaking at my right hand; cold feet; dry mouth; Headaches; body aches; A spontaneous report was received from a 31-year old, female patient who experienced headaches, body aches, dry mouth, cold feet, uncontrolled shaking in right hand, stammering problems, and 200/100 high blood pressure. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided). On 21 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 028L20A) for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient was taken to the emergency room (ER) approximately four hours after receiving the second dose of the Moderna COVID vaccine. She was experiencing headaches, body aches, dry mouth, cold feet, uncontrollable shaking in her right hand, speech impairment, and her blood pressure was 200/100. The patient tested negative for all stroke tests performed in the ER.. The patient reported she received a medication that ""knocked me out"" and relieved the symptoms. Treatment information was not provided. On 23 Jan 2021, the patient still had shaking and stammering problems. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events headaches, body aches, dry mouth, cold feet, and 200/100 high blood pressure were unknown. The outcome of events uncontrolled shaking in right hand and stammering problems were not recovered/ not resolved. Follow up: Follow-up received on 29 Jan 2021 included the patient's report that her adverse events have been sustained and not improved. On 27 Jan 2021, the patient received an MRI that showed brain lesions existed as diagnosed by a neurologist.; Reporter's Comments: The follow-up received reports that on 27Jan 2021, the patient received an MRI that showed brain lesions existed as diagnosed by a neurologist. Based on this information, the event of hypertensive crisis, dysphemia, tremors, is assessed as unlikely related to mRNA-1273.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Dry mouth', 'Dysphemia', 'Headache', 'Hypertensive crisis', 'Myalgia', 'Peripheral coldness', 'Tremor']",1,MODERNA,OT 1062337,OH,,U,"Allowed 4 patients to be vaccinated with the vaccines that experienced a temperature excursion; A spontaneous report was received from a physician regarding product storage error. On 05 FEB 2021, a physician contacted the safety team regarding five (5) vials of Moderna's COVID-19 vaccine (mRNA-1273) that had a temperature excursion of less than 12 hours at maximum of 50 degrees Fahrenheit. It was moved to a refrigerator that was within the acceptable range immediately. She stated that she exercised clinical judgement and allowed 4 patients to be vaccinated with those vials.; Reporter's Comments: This report refers to a case of product storage error regarding five (5) vials of Moderna's COVID-19 vaccine (mRNA-1273) (Lot # unknown) with no reported adverse events. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical history not provided),,,['Product storage error'],1,MODERNA,OT 1062338,NY,39.0,M,"Not able to walk; A spontaneous report was received from a [consumer/physician/nurse/pharmacist/healthcare facility staff member/regulatory authority report] concerning a [age/gender] patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and became unable to walk/gait disturbance. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included unspecified psychiatric medications. On 19 Jan 2021, approximately two days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. The patient lost the ability to walk on 21 Jan 2021 and was hospitalized. He was entered into a rehabilitation facility where he was to start treatment with a physical therapist to walk again. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events fatigue, body aches, loss of taste, chills, and temperature of 99 degrees were not reported. Reporter causality for the events was not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Company assessed the event to be unlikely related to company product.",Not Reported,,Not Reported,Yes,,Yes,U,01/19/2021,01/21/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Gait inability'],1,MODERNA,OT 1062339,TX,,F,"had some bleedings this week; Pregnant; A spontaneous report was received from a nurse concerning a female patient who experienced had some bleedings this week (haemorrhage in pregnancy) and pregnant. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 11 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient found out she was pregnant after the vaccination. Patient also reported that she had some bleedings this week. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events had some bleedings this week and pregnant were unknown.; Reporter's Comments: This is a case of product exposure during pregnancy with an adverse event of bleeding during pregnancy for this female of an unknown age. Patient will continue to be contacted for further monitoring of the AE during the pregnancy. Very limited information regarding the event of Bleeding during Pregnancy has been provided at this time and further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/11/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Exposure during pregnancy', 'Haemorrhage in pregnancy']",1,MODERNA,OT 1062340,,,F,"Heart attack; A spontaneous report was received from a consumer, who was also a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a heart attack (myocardial infarction). The patient's medical history was not provided. No relevant concomitant medications were reported. On an undisclosed date, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an undisclosed date after receiving mRNA-1273, the patient had a heart attack. The patient stated that Moderna should have told her ""about the montelukast allergy"". No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, heart attack, was unknown.; Reporter's Comments: Very limited information regarding this event of heart attack has been provided at this time. Patient's age, medical history, list of concomitant medications, onset date and clinical details of the event is lacking. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Myocardial infarction'],1,MODERNA,OT 1062341,AL,,F,"felt temporary black out; loss of memory; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt temporary black out and temporary loss of memory. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, it was reported that the patient experienced a possible adverse event after the first dose of the vaccine. It was reported that on the night of receiving the vaccine the patient felt temporary blackout and temporary loss of memory. She mentioned that ""she wake up fine the next morning"". No treatment information provided. The outcome of the events felt temporary black out and temporary loss of memory were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Amnesia', 'Loss of consciousness']",1,MODERNA,OT 1062342,DE,,F,"Racing heart; Fever; Pain at injection site; cough; A spontaneous report was received from a consumer concerning a � 67 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like racing heart, cough, fever and pain at injection site. The patient had a history of heart disease. On 24-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 028L20A ) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On 24-JAN-2021, The patient experienced the events like racing heart, cough, fever and pain at injection site with hospitalization as seriousness criteria. The Patient is taking atenolol � every other day. The patient was also advised to take Tylenol. Action taken with mRNA-1273 in response to the events was not reported. On 24- JAN-2021, the outcome of the events like tachycardia, cough, pyrexia, pain at injection site was not resolved. At the time of this report, the outcome of the event tachycardia was resolved and cough, pyrexia , pain at injection site was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient medical history of heart disease remains a confounder for causality.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/24/2021,01/24/2021,0.0,UNK,,"Heart disease, unspecified",,,,"['Cough', 'Heart rate', 'Pyrexia', 'Tachycardia', 'Vaccination site pain']",1,MODERNA,OT 1062343,OK,,M,"inadvertently given vaccine from a vial that was punctured a day before; A spontaneous report was received from a health care professional (HCP) concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) inadvertently from a vial that was punctured a day before/expired vaccine used. The patients' medical history was not provided. Concomitant medication history was not provided. On 13 FEB 2021, the patient received his dose of mRNA-1273 (Lot number 016M20A) intramuscularly for prophylaxis of COVID-19 infection. The HCP stated that this patient was inadvertently given the vaccine from a vial that was punctured a day before. A single dose was taken out of that vial and put back outside the six-hour window. Treatment for this event was not provided. The outcome of the event, expired vaccine used, was recovered on 13 Feb 2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273, Lot number 016M20A with no associated adverse events.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-013964:same reorter, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/13/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No adverse event history),,,['Expired product administered'],1,MODERNA,OT 1062344,CA,71.0,F,"Spot on forearm where vaccine dripped turned red; facility chose to administer another dose; the syringe wasn't screwed in tight enough and the vaccine leaked down her arm; the syringe wasn't screwed in tight enough and the vaccine leaked down her arm; the syringe wasn't screwed in tight enough and the vaccine leaked down her arm; (spot) blistered; A spontaneous report was received from a consumer concerning a 71-year-old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the syringe not tightly screwed on and the vaccine leaked down the patient's arm, received another dose of the vaccine, a red spot developed on her forearm where the vaccine dripped, and later blistered. The patient's medical history was not provided. No relevant concomitant medications were reported. On 05-Feb-2021, during vaccine administration the syringe was not tightly screwed on, and the vaccine leaked down the patient's arm. The facility chose to administer another dose and the patient received two doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID -19 infection. On 07-Feb-2021, two days later, a spot developed on her forearm where the vaccine dripped, turned red, and later blistered. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The events, the syringe was not screwed tightly on and the vaccine leaked down her arm was considered resolved. The events of a spot developed on her forearm where vaccine dripped, turned red, and later blistered were reported as unknown.; Reporter's Comments: This report refers to a case of syringe that was not tightly screwed on and the vaccine leaked down the patient's arm, and the facility chose to administer another dose for mRNA-1273, lot # unknown, with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Blister', 'Device connection issue', 'Erythema', 'Exposure via skin contact', 'Extra dose administered', 'Underdose']",1,MODERNA,OT 1062345,AZ,31.0,M,"some solution leaked out of the syringe; the patient may not have received the recommended .5ml; A spontaneous report was received from a pharmacist concerning a 31-year old, male patient who was scheduled to receive Moderna's COVID-19 vaccine but during the administration the patient may have received an invalid first dose as some solution leaked out of the syringe (syringe leak and underdose). The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient presented to the clinic for their first of two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection. The pharmacist stated that, during attempted administration, the consumer may have received an invalid first dose as some solution leaked out of the syringe and the patient may not have received the recommended 0.5ml. No treatment information was provided. Action taken with mRNA-1273 in response to the event(s) was not reported. The outcome of the events, syringe leak and underdose were considered recovered.; Reporter's Comments: This report refers to a case of syringe issue and underdose for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Syringe issue', 'Underdose']",1,MODERNA,OT 1062346,,,U,"gave the last two doses after the six hours of vaccine viability time; A spontaneous report was received from a healthcare professional concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and the person that was giving the doses gave the last two doses after the six hours of vaccine viability time (expired product administered). The patients' medical history was not provided. Concomitant product use was not provided. On an undisclosed date, the patient received a dose of mRNA-1273 (batch number unknown) for prophylaxis of COVID-19 infection. The reporter stated that they punctured the vial but the person that was giving the doses gave the last two doses after the six hours of vaccine viability time. Treatment information was not provided. The action taken with mRNA-1273 in response to the event was unknown. The event, gave the last two doses after the six hours of vaccine viability time, was considered recovered/resolved on an unknown date.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (batch number unknown) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No adverse event, Continue: true, Comment: No reported medical history",,,['Expired product administered'],UNK,MODERNA, 1062347,,,U,"Gave the last 2 doses after the 6hs punctured vial lifespan; A spontaneous report was received from a consumer concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine who received (mRNA-1273) and the person that was administering the doses gave the last two doses after the six hour of vaccine viability time (expired product administered). The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient received a dose of mRNA-1273 (lot number not provided) for prophylaxis of COVID-19 infection. It was reported that the person that was administering the doses gave the last two doses after the six hour of vaccine viability time. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event gave the last two doses after the six hour of vaccine viability time was considered resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Expired product administered without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Expired product administered'],1,MODERNA, 1062348,AL,,U,"1 dose given to a patient 6 hours and 15 minutes after the first puncture; A spontaneous report was received from a pharmacist concerning a patient, age and gender unknown, who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, dose given to a patient 6 hours and 15 minutes after the first puncture. The patient's medical history was not provided. No relevant concomitant medications were reported. On 14 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. On 14 Feb 2021, a dose of Moderna's vaccine was administered to the patient 6 hours and 15 minutes after the first puncture of vial. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, dose given to a patient 6 hours and 15 minutes after the first puncture, was considered resolved on 14 Feb 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Expired product administered without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/14/2021,02/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Expired product administered'],1,MODERNA, 1062349,NY,55.0,F,"Anaphylactic reaction; rash 3.5 x 5 inches below the injection site; A spontaneous report was received from a consumer concerning a 65-year-old female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction and a vaccination site rash. The patient's medical history included diabetes since an unknown date. Relevant concomitant medications included an unspecified diabetes medication. On 06-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 18-Jan-2021, the patient experienced the event anaphylactic reaction and a vaccination site rash 3.5 x 5 inches. Laboratory details were not provided. Treatment information included fexofenadine and diphenhydramine. Action taken with mRNA-1273 in response to the events was not reported. On 23-Jan-2021, the outcome of the events, anaphylactic reaction and vaccination site rash, was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/18/2021,12.0,UNK,,Allergy (Allergic to hairs.); Sulfonamide allergy (allergic to sulfa drugs),Medical History/Concurrent Conditions: Diabetes,,,"['Anaphylactic reaction', 'Vaccination site rash']",1,MODERNA,OT 1062350,,,M,"Death; A spontaneous was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine and who died. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23-Jan-2021, prior to the onset of the event, patient received their first of two planned doses of mRNA-1273 (Lot number:013620A) intramuscularly for prophylaxis of COVID-19 infection. On 25-Jan-2021, approximately 2 days after injection, patient Died. On 26-Jan-2021, neighbor Reporter called in to report a potential AE death. She shared that she lives in a condo building with other elderly. She shared that she and 2 other neighbors went to a vaccination site in Miami at a fire department. She shared that she is fine but that her neighbor died two days after shot. She shared that she didn't know if he had symptoms and that she knows that he had a lot of medical issues and was on about 15 medicines. She shared that she didn't know his age but guessed 70. She said we can contact his wife, but it must be a Spanish speaking agent because she speaks little English. She is concerned because they all received the vaccine at the same time. She wanted to reiterate that she was fine but believed we should know about the neighbor's death. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event death is not applicable. The patient died on 26-Jan-2021. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. The cause of death was not provided.; Reported Cause(s) of Death: Unknown",Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/25/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Death'],1,MODERNA,OT 1062351,NC,31.0,F,"Not Administered in the Deltoid; Itchy Sensation - Near Elbow; Rash - Near Elbow; Redness - Near Elbow; Swelling - Near Elbow; A spontaneous report was received from a consumer concerning a 31-year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) at the incorrect injection site and experienced rash, redness, swelling, and an Itchy sensation near her elbow. The patient's medical history, is not provided by the reporter. Concomitant medications were not reported. On 21 Jan 2021, the patient received their first of two planned dose of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient began to experienced rash, redness, a lot of swelling, and an Itchy sensation near her elbow where the vaccine was administered. Treatment for the events included ibuprofen Action taken with mRNA-1273 in response to the events was unknown. The outcome of event, incorrect injection site, was considered recovered/resolved on 21 Jan 2021. The outcome of the events, rash, redness, swelling, and an Itchy sensation, was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The causality of the event of vaccine administered at inappropriate site is assessed as not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Incorrect route of product administration', 'Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site rash', 'Vaccination site swelling']",1,MODERNA,OT 1062352,NC,,F,"Face and neck all hot; rash had spread throughout her body; Face was really flushed; tachycardia; fever 99.9-102F; A spontaneous report was received from a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia and fever 99.9-102f. Medical history was not reported. Concomitant medication was not reported. On 01 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) in left arm for prophylaxis of COVID-19 infection. On 01 Feb 2021, the patient experienced face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia with seriousness criteria life threatening and fever 99.9-102f. Treatment medication included Benadryl at a dose of 50 milligram. Action taken with mRNA-1273 in response to the face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia and fever 99.9-102f was not provided. The outcome of the events face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia and fever 99.9-102f was unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced serious unexpected events of severe allergic reaction, tachycardia, rash, flushing, and skin warm, and NS expected event of fever. The events occurred the same day as the first dose of mRNA-1273. Treatment included Benadryl. Event outcome not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Yes,Not Reported,,Not Reported,U,,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Body temperature', 'Flushing', 'Pyrexia', 'Rash', 'Skin warm', 'Tachycardia']",1,MODERNA, 1062353,,,F,"had COVID (double Covid pneumonia); A spontaneous report (United States) was received from an Other Health Care Professional concerning a female patient age not provided who developed COVID (double Covid pneumonia) The patient's medical history was not provided. Concomitant product use was not provided. On 22-Jan-2021, prior to the onset of events, the patient had the first of two planned doses of mRNA-1273, (Batch number was not provided) (route and site was not provided) for prophylaxis of Covid-19 infection. The patient left a voicemail message reporting adverse reactions to the Moderna mRNA-1273 vaccine. The patient reported having ""Covid"". She reported being hospitalized with, "" double Covid pneumonia"". No treatment information or hospitalization details were provided. Agent called the patient back on 26-Jan-2021 and was unable to reach her for more information. Action taken with mRNA-2021 in response to the events was not reported. Outcome of the event had COVID (double Covid pneumonia) was unknown.; Reporter's Comments: This case concerns a female of unknown age who was hospitalized with a serious unexpected event of COVID-19 pneumonia. The event occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/22/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse effect (Medical history was not provided),,,['COVID-19 pneumonia'],1,MODERNA, 1062354,CT,36.0,M,"Syringe and/or needle broke; Did not receive intended dosage volume; A spontaneous report was received from a consumer concerning a 36 year old, white, male patient who received Moderna's Covid 19 vaccine (mRNA1273) and experienced a syringe issue and incorrect dose administration. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. ON 29-JAN-2021, the patient received first of two planned dose of mRNA-1273 (Batch Number 012M20A) intramuscularly for prophylaxis of COVID-19 infection. On 29 Jan 2021, during administration of the vaccine, the syringe plastic broke and patient did not receive the intended dosing volume of 0.5 mL. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the events was not provided/unknown. The outcome of the events, syringe issue and incorrect dose administration, were considered recovered/resolved on 29 Jan 2021.; Reporter's Comments: This report refers to a case of Vaccine underdose and Device connection issue for mRNA-1273 (Batch Number 012M20A) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Device connection issue', 'Underdose']",1,MODERNA,OT 1062355,,,U,"Part of the dose leaked out through the connection of the needle to the syringe; Part of the dose leaked out through the connection of the needle to the syringe; A spontaneous report was received from a healthcare professional (pharmacist) concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced the event part of the dose leaked out through the connection of the needle to the syringe (syringe issue) (underdose). The patient's medical history was not provided. No Relevant concomitant medications was provided. On unknown date, patient received their second of two planned dose of mRNA-1273 (Lot/Batch: unknown) vaccine for prophylaxis of COVID-19 infection. On an undisclosed date, patient experienced the event part of the dose leaked out through the connection of the needle to the syringe. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of events experienced for event part of the dose leaked out through the connection of the needle to the syringe was resolved.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Syringe issue', 'Underdose']",2,MODERNA,OT 1062356,MD,,F,"Pain under right breast; Itching; Shingles right abdomen dermatone; Pain in abdomen; A spontaneous report was received from a consumer concerning a 72, year old, female patient who developed pain under right breast, itching, shingles, and pain in abdomen. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 30-12-2020, approximately four days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 02-JAN-2021 the patient went to an urgent care for pain under the right breast, itching, shingles, and abdominal pain. On 03-JAN-2021 the patient went to the hospital for pain under the right breast, itching, shingles, and abdominal pain. The patient was discharged the same day 03-JAN-2021. Treatment for the event included Lyrica twice daily, Valtrex twice daily, Tramadol and two rounds of Prednisone. The patient self -administered Advil and Tylenol. There was no change planned to the dosing schedule of mRNA-1273 in response to the event(s) and was administered on 27-JAN-2021 The outcome of the event(s) not reported. Follow up: No follow up provided.; Reporter's Comments: This case concerns a 72, year old, female patient who developed pain under right breast, itching, shingles, and pain in abdomen. Very limited information of this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,12/30/2020,01/02/2021,3.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Abdominal pain', 'Herpes zoster', 'Musculoskeletal chest pain', 'Pruritus']",2,MODERNA,OT 1062357,,30.0,F,"Rapid heart beat at 110bpm and today was 120bpm; Sore left arm at injection site; A spontaneous report was received from a consumer, concerning herself, a 30-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rapid heartbeat at 110bpm and today was 120bpm and sore left arm at injection site. The patient's medical history was not provided. Patient had no relevant concomitant medications. On 28 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (010M2A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 28 Jan 2021, after the second dose of vaccine, the patient experienced sore left arm at injection site and rapid heartbeat at 110bpm. On 29 Jan 2021, the patient's heartbeat was about 120bpm, hence she went to emergency room. Patient had no treatment and co-morbidities. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the event's rapid heartbeat at 110bpm and today was 120bpm and sore left arm at injection site were not reported.; Reporter's Comments: This case concerns a 30-year-old female who experienced a serious unexpected event of Heart rate increase along with a nonserious expected event of Vaccination site pain. The events occurred the same day as the second dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/28/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Heart rate', 'Heart rate increased', 'Vaccination site pain']",2,MODERNA,OT 1062358,PA,,F,"Received shot, vial (with) ice crystals in it; A spontaneous report was received from a consumer concerning a 68 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced received shot, vial (with) ice crystals in it. The patient's medical history was not reported. Relevant concomitant medications were reported included Cholesterol medication. On 28th Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly for prophylaxis of COVID-19 infection. The vaccine was administered from a vial with ice crystals that supervisor said was no good. Patient noted she has had no side effects or sore arm after administration. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event vaccine was administered from a vial with ice crystals that supervisor said was no good was considered resolved on 28 Jan 2021.; Reporter's Comments: This report refers to a case of product preparation issue for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,BERGAMOT CHOLESTEROL CARE,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Product preparation error'],1,MODERNA,OT 1062359,OH,56.0,F,"Heart was pounding and racing; Blood pressure was erratic; Dizziness; Bilateral weakness in my legs; Sore arm; A spontaneous report was received from a heath care professional concerning a 56 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm/pain in extremity, dizziness, heart was pounding and racing/ palpitations, bilateral weakness in legs/muscular weakness and blood pressure was erratic/blood pressure fluctuation. The patient's medical history included COVID-19. No relevant concomitant medications were reported. On 21 Jan 2021, 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient experienced sore arm that lasted for 2 days. On 24 Jan 2021, at 2 PM the patient had dizziness and her heart was pounding and racing. She stood up and felt like she was going to fall due to bilateral weakness in her legs and was taken by ambulance to the hospital. She was given medication to control her BP because it was erratic. On 27 Jan 2021, the patient was released from the hospital. Laboratory details as reported by the reporter include systolic blood pressure (BP) of 215, electrocardiogram (ECG), echocardiogram, computerized tomography scan (CT), magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) to check for transient ischemic attack (TIA), depleted oxygen to the brain, and circulation problems. All tests performed came back as normal. Treatment for the events included unspecified blood pressure medication. Action taken with mRNA-1273 in response to the events was not reported. The event, sore arm, was considered resolved on 24 Jan 2021. The events, dizziness, heart was pounding and racing, bilateral weakness in legs and blood pressure was erratic, were considered resolved on 27 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/21/2021,01/22/2021,1.0,UNK,,,Medical History/Concurrent Conditions: COVID-19 (she had COVID-19 in the beginning of January.),,,"['Blood pressure fluctuation', 'Blood pressure systolic', 'Computerised tomogram', 'Dizziness', 'Echocardiogram', 'Electrocardiogram', 'Magnetic resonance imaging', 'Muscular weakness', 'Pain in extremity', 'Palpitations']",1,MODERNA,OT 1062360,IL,,U,"Syringe came apart; Suspension ran down arm; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a syringe issue and incomplete dose. The patient's medical history was not reported. No Relevant concomitant medications were reported. On 26th Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On date 26th Jan 2021, during administration one of the syringes came apart and some of the suspension ran down the patient's arm. Vaccine leaked and patient didn't receive much of the 2nd dose possibly. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the event syringe issue and incomplete dose administered was considered Recovered/Resolved on 26 Jan 2021.; Reporter's Comments: This report refers to a case of syringe issue (comes apart during vaccine administration), and incomplete dose for mRNA-1273, (lot # not provided) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,"['Incorrect dose administered', 'Syringe issue']",2,MODERNA,OT 1062361,GA,78.0,F,"Swollen at the injection site; Lump on Left Arm; Left arm was painful /it was painful to the touch/it more like a numb dull pain; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3246; Expiration Date 28Jan2021), via an unspecified route of administration in the left arm on 26Jan2021 12:15 (at the age of 78-years) as a single dose for COVID-19 immunization. There was a no medical history. The patient's concomitant medications were not reported. The patient received the vaccine on 26Jan2021 and in the evening her left arm was painful, she could not sleep on the arm. On 27Jan2021, before she took a bath, she still had the band aid on and it was still hurting a little, the area was swollen at the injection site, it was painful to the touch, she could feel a lump on the left arm, she still could not sleep on the arm. On 28Jan2021 the swelling went down and was still painful, but it was not a sharp pain, it more like a numb dull pain, she was calling to ask if that is normal. The patient treated herself with paracetamol (TYLENOL) prophylactically 2 hours prior to vaccination and on an unspecified date rubbed some alcohol on the injection site. The swelling was reported as just a little. The lump was completely gone but she still felt the dull pain. The clinical outcome of the event left arm was painful and swollen at the injection site was recovering; and lump on the left arm was recovered on 27Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['SARS-CoV-2 test', 'Vaccination site mass', 'Vaccination site pain', 'Vaccination site swelling']",UNK,PFIZER\BIONTECH, 1062362,NY,26.0,F,"decreased appetite; Sweats; Chills; fever (101.3); headache; Body aches; This is a spontaneous report from a contactable Other-HCP (patient) and another other-HCP. This 26-year-old female received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL0142, intramuscular in left arm on 11Jan2021 at 07:00 as single dose (at the age of 26 years) for Covid-19 Immunization. Relevant medical history was reported as none and concomitant medication was not reported. The patient had historical vaccine on 21Dec2020 at the age of 26 years of BNT162B2 for Covid-19 immunization and experienced Onset of body aches 12 hours after vaccination and lasted for 24 hours. (Lot Number/Expiry Date: EH9899, Route: intramuscular). The patient experienced Body aches, headache, fever, chills, sweats on 11Jan2021 18:00 and recovered on 13Jan2021. Patient received Tylenol extra strength 100mg on 11Jan2021 for symptoms. Patient experienced decrease appetite on unspecified date with outcome of unknown. The other HCP consider the Pfizer product had a causal effect to the adverse event.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/11/2021,0.0,PVT,,,,,,"['Body temperature', 'Chills', 'Decreased appetite', 'Headache', 'Hyperhidrosis', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,OT 1062390,IL,62.0,M,Guillain Barre Syndrome,Not Reported,,Not Reported,Yes,9.0,Not Reported,U,02/04/2021,02/13/2021,9.0,PVT,atorvastatin hydrochlorothiazide lyrica valsartan cyclobenzaprine,None,Hypertension and hyperlipidemia,,None,"['Electromyogram', 'Guillain-Barre syndrome', 'Lumbar puncture', 'Magnetic resonance imaging', 'Magnetic resonance imaging spinal', 'Nerve conduction studies']",UNK,MODERNA, 1062428,CA,17.0,U,"17 year old patient received Moderna vaccine; A spontaneous report was received from a nurse concerning a 17 years-old patient (demographics not provided) who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. Concomitant product use was not provided by reporter. On 16 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot #: 013M20A) (site of administration not specified), intramuscularly for prophylaxis of COVID-19 infection. On 16 Feb 2021, the 17 years-old patient was administered Moderna vaccine. The nurse was inquiring what to do next. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. On 16 Feb 2021, the event 17 year old patient received Moderna vaccine was considered resolved.; Reporter's Comments: This report refers to a case of 17- year-old patient who received for mRNA-1273, lot # 013M20A (Inappropriate age at vaccine administration) . There were no reported AEs associated with this case of Inappropriate age at vaccine administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1062429,NJ,72.0,F,"within a minute of each other the nurse gave 2 full doses of vaccine; hard time breathing; lightheadedness; tinnitus, ringing in ears; redness on left arm; headache; A spontaneous report was received from a relative concerning a 72-year old, female patient who received both Moderna's COVID-19 vaccine (mRNA-1273) doses within a minute of each other and experienced having a hard time breathing, headache, redness on left arm, lightheadedness, and tinnitus- ringing in ears. The patient's medical history was not provided. No relevant concomitant medications were reported. On 14 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly for prophylaxis of COVID-19 infection. Within one minute, the nurse gave her the second dose of mRNA-1273 (Batch number not provided). The patient had a hard time breathing, bad headache, large redness on left arm, lightheadedness, and tinnitus (ringing in ears). The patient took ibuprofen (400 mg) on 14 Feb 2021 and 15 Feb 2021. On 16 Feb 2021, the patient took Advil (200 mg). The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of the event, within a minute of each other the nurse gave 2 full doses of vaccine, was considered resolved on 14 Feb 2021. The outcomes of the events: hard time breathing, redness on left arm, lightheadedness, tinnitus-ringing in ears, and headache is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Dizziness', 'Dyspnoea', 'Headache', 'Inappropriate schedule of product administration', 'Tinnitus', 'Vaccination site erythema']",2,MODERNA,OT 1062430,CA,17.0,F,"daughter who is under 18 received the vaccine; A spontaneous report received from a Consumer concerning, 17-year-old, female patient who received dose of Moderna COVID-19 vaccine. The patient's medical history was not included. Patient's concomitant was not included. On 19JAN2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: 025L20A) intramuscularly for prophylaxis of COVID-19 infection. Patient father stated that his daughter who was under 18 received her 1st dost of the Moderna COVID-19 vaccine. Father stated when he took her back for the 2nd dose of the Moderna COVID-19 vaccine the facility denied her. Treatment information was not included/ unknown. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was considered as recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number 025L20A) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1062431,WI,90.0,F,"Warm to the touch; Tender; Swollen; Red spot; A little off from deltoid muscle; A spontaneous report received from a consumer concerning, 90-year-old, female patient who received Moderna's COVID-19 vaccine a little off from the deltoid muscle and experienced redness, swelling, warm to the touch, and tenderness. PT: [Product administered at inappropriate site, injection site erythema, injection site swelling, injection site warmth, and tenderness]. The patient's medical history was not included. Patient's concomitant included calcium, vitamin D, levothyroxine sodium, atorvastatin, citalopram hydrochloride, amitriptyline, triamterene/hydrochlorothiazide, acetylsalicylic acid, and lorazepam. On 02 FEB 2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in left arm (Batch #: 007M20A) for prophylaxis of COVID-19 infection. On 02 Feb 2021, the patient received the vaccine 'a little off from the deltoid muscle' as described by the patient's daughter (nurse). Approximately 9 days later, the patient developed a red spot on her arm and it was swollen and warm to the touch. At the time of the report, the patient's arm was still swollen. The redness was fading and her arm was tender. Treatment for this event included paracetamol. Action taken with mRNA-1273 in response to the event was not provided/unknown. The event, vaccine administered at inappropriate site, was considered recovered/resolved on 02 Feb 2021 The event, redness was considered recovering/resolving. The events, swelling and tenderness, was considered not recovered/not resolved. The outcome of the event, tenderness, was unknown/ not reported.; Reporter's Comments: This report refers to a case of product administered at inappropriate site for mRNA-1273, (lot # 007M20A) with associated injection site erythema, swelling, warmth, and tenderness. Based on the current available information and temporal association between the use of the product and the start date of the injection site events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,UNK,CALCIUM; VITAMIN D NOS; SYNTHROID; ATORVASTATIN; CELEXA [CITALOPRAM HYDROBROMIDE]; AMITRIPTYLINE; TRIAMTERENE & HCTZ; BABY ASPIRIN; LORAZEPAM,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Product administered at inappropriate site', 'Tenderness', 'Vaccination site erythema', 'Vaccination site swelling', 'Vaccination site warmth']",1,MODERNA,OT 1062432,CA,71.0,F,"Dose leaked during administration of vaccine; did not receive the full dose of the vaccine; vaccine leaked down arm; A spontaneous report was received from a consumer concerning a 71 year old, female patient who experienced the syringe connection issue, vaccine underdose, and exposure via skin contact. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 14-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly in the arm for prophylaxis of COVID-19 infection. While receiving the vaccine, the patient said the vaccine leaked down her arm and did not receive the full dose. Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the events,syringe connection issue, vaccine underdose, and exposure via skin contact were recovered.; Reporter's Comments: This case concerns a 71-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 011M20A), reporting Underdose, device connection issue, and exposure via skin contact without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/14/2021,02/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no medical history reported),,,"['Device connection issue', 'Exposure via skin contact', 'Underdose']",1,MODERNA,OT 1062433,PA,59.0,F,"Missed second dose; COVID-19; A spontaneous report was received from a health care professional concerning a 59-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was diagnosed with COVID-19, missed second dose. Crosslinked case is MOD21-031684. The patient's medical history was not provided. Relevant concomitant medications were reported i.e., methotrexate, Prozac, lamictal, Ritalin. On 05Jan2021 prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273(lot/batch: 026L20A) intramuscularly in the left dominant arm for prophylaxis of COVID-19 infection. Laboratory data was not provided. Treatment details included steroids and ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event was reported that with help of steroids the patient felt better at the third week window.; Reporter's Comments: The event of COVID-19 was consistent with infection in pandemic set up. Very limited information regarding these events has been provided at this time. The event of COVID-19 is assessed as not related to company product.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/18/2021,13.0,UNK,METHOTREXATE; PROZAC; LAMICTAL; RITALIN,,Medical History/Concurrent Conditions: COVID-19 (no end date given for recovery of COVID),,,"['COVID-19', 'Inappropriate schedule of product administration']",1,MODERNA,OT 1062434,MN,94.0,F,"Pt received 1st dose on 03FEB2021 and 2nd dose on 14FEB2021; A spontaneous report was received from a caregiver regarding a 94-year-old female patient who received Moderna's mRNA-1273 vaccine first dose on 03 February 2021 and second dose on 14 February 2021/Inappropriate schedule of vaccine administered. The patient's medical history was not provided. Concomitant medications were not provided. On 03 February 2021, the patient received the first of two planned doses of mRNA-1273 (Batch: unknown) for prophylaxis of COVID-19 infection. On 14 February 2021, the patient received the second of two planned doses of mRNA-1273 (Batch: unknown) for prophylaxis of COVID-19 infection. This dose was administered earlier than guidelines recommend. Treatment information was not provided. Action taken with mRNA-1273 was not applicable. The outcome of the event, receiving first dose on 03 February 2021, and the second dose on 14 February 2021, was considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/14/2021,11.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Inappropriate schedule of product administration'],2,MODERNA,OT 1062435,AK,,U,"faulty needle and syringe that caused leakage to occur; Not the entire quantity was injected into the patient; incomplete dose administered; A Spontaneous report was received from a pharmacist concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a faulty needle and syringe that caused leakage to occur and not the entire quantity was injected into the patient. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received a dose of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, it was reported that a faulty needle and syringe caused leakage to occur and the patient did not receive the entire quantity of the vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The events of faulty needle and syringe that caused leakage to occur and not the entire quantity was injected into the patient was considered resolved on an unspecified date.; Reporter's Comments: This report refers to a case of a patient of unknown age and gender who experienced non-serious unexpected event of faulty needle and syringe that caused leakage to occur and not the entire quantity was injected into the patient (device connection issue, incomplete dose administered) for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of device connection issue and incomplete dose administered",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Device connection issue', 'Underdose']",1,MODERNA,OT 1062452,OH,44.0,F,"Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response. 02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine. 02.04.21 Pt presents to Ed with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,PUB,,None,"Osteoporosis, HTN, Anemia",,"Ananphylaxis to iron infusion, blood transfusion","['Alanine aminotransferase normal', 'Aspartate aminotransferase normal', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bilirubin normal', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine normal', 'Blood glucose normal', 'Blood magnesium increased', 'Blood potassium decreased', 'Blood pressure increased', 'Blood sodium normal', 'Blood urea normal', 'Carbon dioxide normal', 'Chest discomfort', 'Chest pain', 'Differential white blood cell count normal', 'Discomfort', 'Emotional distress', 'Erythema', 'Globulin', 'Glomerular filtration rate normal', 'Haematocrit normal', 'Haemoglobin normal', 'Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Injection site urticaria', 'Lymphocyte count decreased', 'Lymphocyte percentage', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Monocyte count normal', 'Neutrophil count increased', 'Neutrophil count normal', 'Peripheral swelling', 'Platelet count normal', 'Protein total normal', 'Pruritus', 'Pulmonary embolism', 'Rash', 'Red blood cell count normal', 'Swelling', 'Tinnitus', 'Troponin normal', 'Urticaria', 'White blood cell count normal']",1,PFIZER\BIONTECH,IM 1062457,WI,81.0,M,"Patient admitted for fatigue, dry throat, generalized weakness, dyspnea on exertion. Durion hospitalization was identified to have an acute ischemic CVA -- unclear time of symptom onset, possibly evening of 2/9 or morning of 2/10. Time course suspicious for possible COVID vaccine adverse event. He received his first Moderna COVID vaccine on 2/2/21 per WIR. Per PCP note on 2/9/21: Patient is here today accompanied by his wife with concerns for fatigue, headaches, head pressure and tremors. Received vaccine last Tuesday. Around 10 PM that evening he developed pressured in the head. On Wednesday morning, he states he got out of bed and was in a cold sweat - he states he pajamas were soaked in sweat and he felt chilled. He experienced brief numbness of the left arm down to his fingers. On Thursday, he felt fine - he went out to snow blow. Friday he developed headaches and head pressure. At night, he felt his breathing was labored as he was ""gasping for air."" On Saturday and Sunday, he sat and laid around all day. On Monday, he wakes up at 125 AM and his blood pressure was 165/104 and it remained elevated for 3 separate readings. Patient was then admitted on 2/10/21 with weakness and confusion, then on 2/11 MD noted ?word finding difficulty, slurred speech, possible subtle right upper lip droop, and possibly some mild right hemineglect? with MRI showing likely embolic source of infarcts and cerebral MRA with possible acute thrombus. His symptoms the day after the vaccine seem a bit suspicious for TIA. Per Drug Policy Manager call to Moderna, no current reports of TIA/stroke secondary to COVID vaccine, so time course may be incidental. Patient had echocardiogram without right to left shunt or clot identified, no known history of atrial fibrillation. Was monitored on telemetry for the duration of his hospitalization without any noted arrhythmias, discharged on e patch for 14-day outpatient monitoring.",Not Reported,,Yes,Yes,3.0,Not Reported,U,02/02/2021,02/09/2021,7.0,PUB,acetaminophen alprazolam Execdrine Hydroxyzine ibuprofen,,,,NKDA,"['Angiogram abnormal', 'Asthenia', 'Blood pressure increased', 'Cerebral ischaemia', 'Chills', 'Cold sweat', 'Confusional state', 'Dry throat', 'Dysarthria', 'Dyspnoea', 'Dyspnoea exertional', 'Echocardiogram', 'Embolic cerebral infarction', 'Fatigue', 'Head discomfort', 'Headache', 'Hypoaesthesia', 'Magnetic resonance imaging abnormal', 'Magnetic resonance imaging brain abnormal', 'Transient ischaemic attack', 'Tremor']",1,MODERNA, 1062546,PA,51.0,M,"On Wednesday, February 24th I received the first dose of the Moderna vaccine. On Friday evening I developed joint pain and swelling in my left should blade, my right wrist and my left large toe. The pain in my shoulder and my wrist is excruciating and I have not been able to sleep properly. I have very limited mobility and cannot grip with or use my right hand. I started taking 200 mg of ibuprofen on Friday night with food but it did not seem to reduce the pain. Through the night that night I increased my dose to 400 mg and felt some relief in my shoulder but my hand is still very painful. My toe is uncomfortable but tolerable. I used tiger balm several times on my wrist but that did not help. I also put it on my back and it seemed to help as long as I did not move. If I moved a felt a very sharp pain under my shoulder blade. I used ice on my hand and it only benefited briefly. I couldn't apply it at night and therefore couldn't sleep. I am unable to move or function as I normally would due to the sharp pains in my back/shoulders and right hand. Unable to function without assistance and cannot go to work.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/24/2021,02/26/2021,2.0,PUB,"Type 1 diabetic. Inject Lantus and Novalog insulin daily via pen. Also taking tadalafil for prostate, lisinopril, atorvastatin, and amlodipine for blood pressure. Testosterone injection once a week. Multivitamin, vitamin D, and Zinc.",Hypertension,"Type 1 Diabetes, mild psoriasis.",,None.,"['Arthralgia', 'Grip strength decreased', 'Impaired work ability', 'Joint swelling', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Sleep disorder']",1,MODERNA,IM 1062550,AL,63.0,M,Patient's daughter called to report that about 30 hours after receiving the vaccine he passed away at home. She said she didn't know the cause of death but she felt like she should let us know about it.,Yes,02/18/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/18/2021,1.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1062587,PA,34.0,F,I have a complicated pregnancy. I was hospitalized on 01-19-2021 at about 10pm. I had repeated bleeding episodes. At the hospital they diagnosed me with chronic placental abruption. I delivered my baby by emergency C-section. I also had left arm soreness at the injection site.,Not Reported,,Not Reported,Yes,8.0,Not Reported,Y,01/19/2021,01/19/2021,0.0,PVT,"Pre-natal vitamins, stool softener, iron supplements",Diagnosed wit subcoriandric hemorrhage,,,Bactrim,"['Caesarean section', 'Haemorrhage in pregnancy', 'Injection site pain', 'Premature separation of placenta']",2,PFIZER\BIONTECH,IM 1062589,,51.0,M,Had very mild Tinnitus prior to vaccine after second vaccine Tinnitus got significantly worse and has not gotten any better. I also had vertigo after vaccine for three weeks which I had never had before.,Not Reported,,Not Reported,Not Reported,,Yes,N,01/25/2021,02/01/2021,7.0,PVT,"alprazolam, Crestor,CoQ10, vitamin D",very mild Tinnitus,,,"BHT, BHA, Sodium Benzoate","['Tinnitus', 'Vertigo']",2,PFIZER\BIONTECH, 1062638,ME,,M,"Lost his appetite; He thinks he got the shot very high in his arm; Arm was sore for a couple of days; Feeling down and has been resting in bed a lot; Feels weak; Chills; Muscle pain; A spontaneous report, was received from a consumer (patient), an 82-year-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine, and experienced arm was sore for a couple of days (pain in extremity), loss of appetite (decreased appetite), feeling down and has been resting in bed a lot (depressed mood), feels weak (asthenia), chills, muscle pain (myalgia), and patient thinks he got the shot very high in his arm (product administered at inappropriate site). The patient's medical history was not reported. Concomitant medications included insulin, dulaglutide, and unspecified statins for cholesterol. On 04 Feb 2021, prior to the onset of events, the patient received their first of two planned does of mRNA-1273 (Lot number: 013L20A), intramuscularly very high in arm for the prophylaxis of COVID-19 infection. On the same day, the patient questioned the placement of his vaccination and reportedly thinks that he got the first dose of vaccine very high in his arm. Since the injection on 04 Feb 2021, the patient reported that his arm was sore for a couple of days, and loss of appetite for the last 8-10 days since 06 Feb 2021. The patient also experienced that he was feeling down in the last days and resting in bed a lot associated with chills, feels weak, and muscle pain since an unknown date in Feb 2021 after the Moderna vaccine. Treatment medication included was dextromethorphan hydrobromide; doxylamine succinate; ephedrine sulfate; ethanol; paracetamol which was given three times. Action taken with the second dose of mRNA-1273 in response to the events was not reported. The outcome for the events, arm was sore for a couple of days, loss of appetite, feeling down and has been resting in bed a lot, feels weak, chills, muscle pain, were not provided, and that of event patient thinks he got the shot very high in his arm, was recovered on 04 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The causality for the event of vaccine administered at inappropriate site is assessed as Not Applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/01/2021,,UNK,INSULIN; TRULICITY,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Asthenia', 'Chills', 'Decreased appetite', 'Malaise', 'Myalgia', 'Pain in extremity', 'Product administered at inappropriate site']",1,MODERNA,OT 1062639,NY,,U,"patient did not get the full dose; syringe malfunction; A spontaneous report was received from a healthcare professional concerning a patient, of unknown age and gender, who was administered Moderna's COVID-19 vaccine but due to syringe malfunction/ PT: device connection issue, the patient did not get the full dose/ PT: underdose. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch/Lot number: not provided) intramuscularly for prophylaxis of Covid-19 infection. It was reported that due to a syringe malfunction that day, the patient didn't get the full dose. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The events, syringe malfunction and patient did not get the full dose, were considered resolved.; Reporter's Comments: This report refers to a case of Vaccine underdose and Device connection issue for mRNA-1273 (Batch/Lot number: not provided) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,No adverse event (No reported medical history.),,,,"['Device connection issue', 'Underdose']",1,MODERNA,OT 1062640,MI,,F,"Vaccine given on 19th day; A spontaneous report was received from a nurse concerning a 93-years-old, female patient to whom Vaccine was given on the 19th day. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Lot number not provided) on an unknown date. On unknown date, the patient received their second of two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient was administered the second dose of the vaccine on the 19th day. Reporter to call back with additional information. Treatment information was not provided/unknown. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. On an unknown date, the event vaccine given on the 19th day, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported Medical history),,,['Inappropriate schedule of product administration'],2,MODERNA,OT 1062641,CA,56.0,F,"Nausea; Hard knot in subcutaneous layer; Chills; Body aches; Redness; Believes second dose was administered wrong, didn't feel the needle entered the muscle.; Arm was hot to touch; A spontaneous report (United States) was received from a health care professional who is a 56-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and arm was hot to touch/vaccination site warmth, had hard knot in the subcutaneous layer/vaccination site induration, chills, body aches/myalgia, redness/vaccination site erythema, nausea and believes second dose was administered wrong, didn't feel the needle enter the muscle/incorrect route of product administration. The patient's medical history was not provided. No concomitant product use was reported. On 13 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 015M20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 Feb 2021, post vaccination, the patient reported her arm was hot to touch. The patient believed the injection was administered incorrectly. She reported that she did not feel the needle enter the muscle. On 14 Feb 2021, the patient reported she had a hard knot in the subcutaneous layer, she had chills, body aches and redness. On 15 Feb 2021, the patient reported she had nausea. On 16 Feb 2021, the patient reported she still had redness. Treatment for the event included acetaminophen. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, arm was hot to touch/vaccination site warmth, had hard knot in the subcutaneous layer/vaccination site induration, chills, body aches/myalgia, nausea and believes second dose was administered wrong, didn't feel the needle enter the muscle/wrong technique in product usage process, were considered recovered/resolved. The outcome of the event, redness/vaccination site erythema, was considered not recovered/not resolved.; Reporter's Comments: This case concerns a 56-year old female patient who received mRNA-1273 and experienced non-serious events vaccination site warmth, induration, myalgia, erythema, nausea and believes second dose was administered wrong /incorrect route of product administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,02/13/2021,28.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Chills', 'Incorrect route of product administration', 'Myalgia', 'Nausea', 'Vaccination site erythema', 'Vaccination site induration', 'Vaccination site warmth']",1,MODERNA,OT 1062642,WI,66.0,F,"Injection site mass; Injection site swelling; Tenderness at the injection site; Joint ache; Muscle ache; Fever; Injected twice with the same syringe; A spontaneous report was received from a consumer concerning a 66 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injected twice with the same syringe, injection site mass, injection site swelling, tenderness at the injection site, muscle ache, joint ache and fever. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Feb 2021, 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: unknown ) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Feb 2021, the patient was injected twice during vaccination. She reported the vaccinating pharmacist made a mistake and had to start over using the same syringe. On unknown dates following vaccination, the patient experienced injection site swelling, tenderness at the injection site, muscle ache, joint ache and fever. She reported the fever is now gone. Treatment for the events included ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, injected twice with the same syringe, was resolved on 12 Feb 2021. The outcome of the event fever, was resolved on an unknown date. The outcome of the events, injection site mass, injection site swelling, tenderness at the injection site, muscle ache and joint ache were unknown.; Reporter's Comments: This case concerns a 66-year-old female who had NS unexpected Product administration error, injection site mass and NS expected fever, arthralgia, myalgia, injection site swelling, injection site pain. She was injected twice with the same syringe. Events occurred the same day as first dose mRNA-1273. Treated with ibuprofen. Fever resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Arthralgia', 'Injection site mass', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Product administration error', 'Pyrexia']",1,MODERNA,OT 1062650,NH,74.0,M,"At approximately 24 hours after his vaccine, Pt started to have problems with his vison and headache on the right side. It took 2 calls to 911 before I could convince him to go the the ER. While there, he suffered 2 grand mal seizures and he was transferred to another hospital for further treatment.",Not Reported,,Not Reported,Yes,4.0,Yes,N,02/21/2021,02/22/2021,1.0,PUB,"Spiriva, Symbicort, Albuterol inhaler and nebulizer, multivitamin, D-3, aspirin 81mg,Lisinopril 5mg, Torsemide 80 mg, metroprolol Succinate 25 mg. Apixaban 5mg, twice daily, tylenol 1000mg twice daily, Rosuvastatin 40mg, melatonin 12 mg, D",,"COPD, heart disease",,gluten,"['Generalised tonic-clonic seizure', 'Headache', 'Visual impairment']",1,MODERNA,IM 1062666,TX,68.0,M,"2-24-21 patient with development of cough, fatigue, increasing on chronic disability worsening debility and falls. scheduled for office visit 2-25.21 0900 call from spouse 0210 am patient was not breathing and lvad alarming low flow alarm on arrival of ems confirm asystolic not breathing and dead",Yes,02/25/2021,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/25/2021,3.0,PVT,"AMIODARONE, DOXYCYCLINE, LACTULOSE, OCTREOTIDE, POTASSIUM CHLORIDE, TORSEMIDE, WARFARIN","CONGESTIVE HEART FAILURE ON LEFT VENTRICULAR ASSIST DEVICE MALNUTRITION, DEBILITY",EOSINOPHILIC MYOCARDITIS GI BLEED,,NO KNOWN DRUG ALLERGIES,"['Asthenia', 'Cardiac arrest', 'Catheterisation venous', 'Cough', 'Death', 'Disability', 'Fall', 'Fatigue', 'Respiratory arrest']",2,MODERNA,IM 1062695,OH,72.0,M,Rhabdomyolysis,Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,02/06/2021,02/18/2021,12.0,PHM,"Metamucil, vitamin D, low dose aspirin",None,None,,None,['Rhabdomyolysis'],1,MODERNA, 1062765,MD,44.0,F,"lower back spasm -lasted 3 days even with steroids, pain medication and muscle relaxers, unable to move lower extremities, vomitting due to pain, after three days in hospital for the for one month after still continued with periodic spasms. Physical therapy twice a week little relief. The very next day after the second vaccine had another major attack that with same symptoms. Went to physiatrist linked the lyme and vaccine, placed me on cerebrex and in a little over a week I was able to go one day without any spasms and pain for the first time in over a month.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/08/2021,01/11/2021,3.0,PVT,none,none,Lyme disease,,none,"['Condition aggravated', 'Magnetic resonance imaging', 'Mobility decreased', 'Muscle spasms', 'Pain', 'Vomiting', 'X-ray']",2,MODERNA,IM 1062788,MA,69.0,F,"Day after injection I got out of bed and was UNABLE to walk, nor could I crawl on my knees. I belly crawled to the bathroom but was unable to get up on the toilet. The symptoms improved over the course of the day but was not able to walk normally until the following day. I experienced vomiting, headaches (still persist) brain fog (continues) and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/16/2021,1.0,PVT,"Tacrolimus, Prednisone, Ursodial, Omeprazole, Propranolol, Tramadol, Gabapentin, Lorazepam, Tylenol, Advair, Ventolin Inh","Lumbar ridulopathy,","S/P LDLT, CRF, HTN, ICA aneurysm S/P STENTING,",,"Environmental, root vegetables, Olanzapine","['Fatigue', 'Feeling abnormal', 'Gait inability', 'Headache', 'Inability to crawl', 'Mobility decreased', 'Neurological examination', 'Vomiting']",UNK,MODERNA,SYR 1062807,,66.0,F,Possible Myesthenia crisis after 2nd dose of Pfizer vaccine. Currently in ICU receiving mechanical ventilation,Not Reported,,Not Reported,Yes,,Not Reported,,02/17/2021,02/18/2021,1.0,PVT,,,"CKD, DM, HTN, Thyroid cancer, ischemic stroke, Myesthenia Gravis",,Magnesium,"['Condition aggravated', 'Intensive care', 'Mechanical ventilation', 'Myasthenia gravis']",2,PFIZER\BIONTECH,IM 1062815,NJ,39.0,F,About 5-10 minutes after the vaccine I began to feel extremely dizzy and began sweating. About 10 minutes 10 minutes later I also noticed that the left side of my face and throat began to get swollen and sore. I was taken to the ER via ambulance and was treated with prednisone and pain medications,Not Reported,,Not Reported,Not Reported,,Yes,U,03/08/1981,02/27/2021,14601.0,OTH,"gabapentin, xanaflex, zoloft, meloxicam, hydroxyzine, diclofenac",,"asthma, chronic pain, migraines",,"percocet, iv contrast, ampicillin","['Blood test', 'Dizziness', 'Facial pain', 'Hyperhidrosis', 'Magnetic resonance imaging brain', 'Oropharyngeal pain', 'Pharyngeal swelling', 'Swelling face']",1,MODERNA,IM 1062821,ME,81.0,F,patient developed unexplained diplopia and vertigo; extensive diagnostic workup including mris and LP. Felt to have aseptic meningitis with vestibular neuronitis,Not Reported,,Not Reported,Yes,15.0,Not Reported,,01/25/2021,02/05/2021,11.0,OTH,"alendronate,aleve, aspirin,hctz, lisinopril, lovastatin",none,"hypertension,osteoporosis, hyperlipidemia,melanoma,",,none known,"['Diplopia', 'Lumbar puncture normal', 'Magnetic resonance imaging', 'Magnetic resonance imaging normal', 'Meningitis aseptic', 'Vertigo', 'Vestibular neuronitis']",1,PFIZER\BIONTECH, 1062827,OK,70.0,M,"He had the vaccine, and around 5:00 PM said he had weakness and he fell to the floor. Then his wife asked if he was alright as he had yelled for her prior to that. She went and found him on the floor, but stated that he was alright. Did not hit his head or anything. Got him up and lied him on the bed. His left leg was under his right leg and she asked him to straighten it out, and did not respond with an answer regarding moving his leg. Was looking at her with a glazed look and did not answer, and did not talk or respond to anything. He was propped up against the door and did not respond she called 9-1-1. They took him to the hospital, did not respond. Now his left side is paralyzed and he did have a brain bleed in the front cerebral lobe. To this day 3/1/21 has been in the hospital and still does not have movement on his left side. He is able to talk now every now or then, does speak sentences more, and other days he's not able to speak or move. On 2/20/21 because he has been able to talk, and not able to eat they had to insert a feeding tube into his stomach. At that time he was at one place for 1 day and transferred to Hospital until 2/27/21. He is now at Retirement and Skilled Care facility for rehab.",Not Reported,,Not Reported,Yes,38.0,Yes,N,01/20/2021,02/20/2021,31.0,OTH,"Carvedilol, baby aspirin, Levothyroxine, glipizide, furosemide, atorvastatin, Amlodipine. Calcium. Insulin Novolog 70/30.",None.,"Heart disease, diabetes, chronic back pain, neuropathy in his feet.",,None.,"['Aphasia', 'Asthenia', 'Cerebral haemorrhage', 'Computerised tomogram head abnormal', 'Fall', 'Feeding disorder', 'Gastrointestinal tube insertion', 'Gaze palsy', 'Hemiplegia', 'Mobility decreased', 'Staring', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 1062830,TX,92.0,F,92 yo female who received her first dose of Moderna vaccine on 1/11/2021 with no known adverse effects. Admitted to the hospital on 1/17/21 with a spine compression fracture. Discharged and readmitted on 1/19 /21 with nausea and vomiting. Found to have new atrial flutter and elevated troponin attributed to NSTEMI. Discharge on Aspirin and Plavix. No cath. Second dose of Moderna vaccine 2/25/21. No immediate reaction. One hour later began to feel progressively weak. EMS called shortly after getting home. Intubated in the field. Died at 0658 on 2/26/21 s/p PEA arrest without ROSC.,Yes,02/26/2021,Not Reported,Yes,1.0,Not Reported,N,02/25/2021,02/25/2021,0.0,PVT,APAP 1 gm po tid ASA 81 po qd Atorvastatin 40 mg po qhs Bisacodyl 10 mg PR qd prn constipation Bisacodyl EC 5 mg po qhs prn constipation Cholecalciferol 2000 units po qd Methocarbamol 500 mg po bid Metoprolol succinate 25 mg po qd Miral,1/17/21 Spine compression fracture 1/19/21 New diagnosis of atrial flutter and NSTEMI,HTN Chronic back pain Osteoarthritis,,Trazodone - tachycardia and numbness of extremities (hands/feet),"['Asthenia', 'Death', 'Endotracheal intubation', 'Pulseless electrical activity']",2,MODERNA,IM 1062853,MO,16.0,F,"Per MD's note on patient's chart on 2/26/21: Spoke with both the patient's mother and father today. Patient is 16 and received Moderna vaccine. Both state's current guidance and my correspondence with CDC indicate that she should receive 2nd dose of Moderna and not change to Pfizer. Patient does have a history of Rett Syndrome (rare neurologic genetic defect). Parents report 1 week after receiving Moderna vaccination, she experience her first seizure and was transported and treated at Hospital. Seizures can be a feature of this disorder but the patient had not experienced one in the past. Her parents report that her Neurologist does not believe the seizure to be related to vaccination. I informed parents I would search the VAERS system for similar reports. They were not enrolled in V-Safe, but I encouraged them to do so and gave them a link to the CDC site for registration. Correspondence with CDC (via email): ""If the Moderna vaccine is inadvertently administered to patients 16 or 17 years old instead of Pfizer-BioNTech as the first dose, CDC currently recommends that the Moderna vaccine may be administered as the second dose (as off-label use). The second dose should be administered as close to the recommended interval as possible, 28 days for the Moderna vaccine. Additional information regarding administration errors and deviations can be found in CDC?s current interim clinical considerations regarding mRNA COVID-19 vaccines.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/03/2021,02/03/2021,0.0,PUB,,,,,,"['Off label use', 'Product administered to patient of inappropriate age', 'Seizure']",1,MODERNA,IM 1062856,CA,68.0,F,Status epilepticus - treated with home vimpat and phenytoin load Septic shock requiring norepinephrine,Not Reported,,Yes,Yes,2.0,Not Reported,Y,02/27/2021,02/28/2021,1.0,PVT,"Atorvastatin 40, Lisiopril 5, Sertraline 100, Spiria, Clopidogrel 75, metoprolol 25, Albuterol, Vimpat",,"Epilepsy, asthma, OCOPD, HTN, HLD, saccular aneurysm, takotsubo cardiomyopathy",,"ASA, crab, doxycycline","['Septic shock', 'Status epilepticus']",UNK,MODERNA,IM 1062877,MO,90.0,F,Stroke like symptoms and treated for CVA with Altapace,Not Reported,,Not Reported,Yes,,Yes,U,02/23/2021,02/24/2021,1.0,PVT,unknown,,,,Cipro PCN,"['Cerebrovascular accident', 'Neurological symptom']",2,PFIZER\BIONTECH,IM 1062887,NY,52.0,F,"patient presented to ED post covid vaccination with anaphylactic symptoms. Elevated BP, upper lip swelling, mild edema of all four extremities, tachycardia. Patient received epi, Benadryl, famotidine, dexamethasone. Patient was admitted for four days due to edema in all four limbs and difficulty ambulating. Patient has been out of work and subsequently readmitted for cardiac, BP and Edema issues",Not Reported,,Not Reported,Yes,4.0,Yes,N,01/04/2021,01/04/2021,0.0,PVT,,,,,Penicillins,"['Anaphylactic reaction', 'Blood pressure abnormal', 'Blood pressure increased', 'Cardiac disorder', 'Epinephrine', 'Gait disturbance', 'Impaired work ability', 'Lip swelling', 'Mobility decreased', 'Oedema peripheral', 'Tachycardia']",1,MODERNA,IM 1062895,,90.0,F,patient passed away within 60 days of receiving a COVID vaccine,Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,,01/11/2021,02/28/2021,48.0,SEN,,,,,,['Death'],1,MODERNA, 1062931,NM,81.0,M,"On 02/17/2021, patient received the second dose of COVID-19 Moderna vaccine in the left arm. Approximately 3 days post-administration, patient developed pain, swelling and erythema of the shoulder extending to the posterior/proximal anterior sections of the arm. Patient was unable to move arm due to swelling and presented to the Medical Center Emergency Department on 02/22/2021. A CT of the extremities revealed cellulitis, myositis, and possible fasciitis without abscesses. Subsequent MRI found myositis and cellulitis without evidence of osteomyelitis. Patient began to develop erthematous blotches and an Infectious disease consult was placed. Patient was started on broad-spectrum antibiotics (Ceftriaxone, vancomycin, and clindamycin). After cultures were obtained, patient was de-escalated to ceftriaxone. Two sets of blood cultures taken prior to antibiotics and a left arm swab showed no growth (finalized). On 02/26/2021 patient underwent incision and debridement of left arm with findings of edematous soft tissue without abscess or necrosis. On 02/28/2021 all antibiotics were discontinued per Infectious Disease provider due to lack of concern for infection.",Not Reported,,Not Reported,Yes,7.0,Not Reported,N,02/17/2021,02/20/2021,3.0,PUB,"Aspirin 81mg- 1 tablet PO daily, baclofen 10mg, carbidopa-levo carbidopa-levodopa 25-100mg 1 tablet PO 4 times daily, carvedilol 3.125mg- 1 tablet 2 times daily, cholecalciferol 10mcg, folic acid 1mg - 1 tablet 2 times daily, gabapentin 300",Immunosuppressed- on Actemra/Prednisone medications,"Advanced Parkinson's disease, chronic atrial fibrillation, debility-wheelchair bound, giant cell arteritis","Erythema of the right arm after first dose of IM Moderna- COVID19 vaccine (on 01/22/2021, 80 years old, administered at Communit","Iodinated contrast-renal dysfunction, UTI","['Arthralgia', 'Blood culture negative', 'Cellulitis', 'Computerised tomogram abnormal', 'Debridement', 'Erythema', 'Laboratory test', 'Magnetic resonance imaging abnormal', 'Mobility decreased', 'Myositis', 'Oedema', 'Peripheral swelling', 'Rash macular']",2,MODERNA,IM 1062984,FL,80.0,M,"Weakness; 80% blockage of the carotid artery; Could not walk; chills; A spontaneous report was received from a consumer regarding her spouse, a 70-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 80% blockage of the carotid artery/carotid artery occlusion, could not walk/gait disturbance. Weakness/asthenia and chills. The patient's medical history was not included. Products known to have been used by the patient were not provided. On 20 January 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 29 January 2021, approximately ten days after the mRNA-1273 vaccine was given, the patient experienced 80% blockage of the carotid artery, he could not walk, weakness and chills. He was taken to the emergency room, where he was admitted for two weeks. During this time, he had carotid artery surgery. His primary care doctor could not confirm whether he had a TIA. The consulting neurologist thought the symptoms might be related to the vaccine. Action taken with mRNA-1273 was not reported. The outcome of the events, 80% blockage of the carotid artery, he could not walk, weakness and chills, were considered unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/20/2021,01/29/2021,9.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical History Not Provided),,,"['Asthenia', 'Carotid artery occlusion', 'Chills', 'Gait disturbance']",1,MODERNA,OT 1063000,WI,79.0,M,Patient passed away within 60 days of receiving a COVID vaccine,Yes,02/27/2021,Not Reported,Not Reported,,Not Reported,,01/25/2021,02/27/2021,33.0,PHM,,,,,,['Death'],1,MODERNA, 1063018,IA,86.0,M,The local hospice agency notified us that this patient was now under their care. The patient is experiencing severe intestinal inflammation to the point that he was admitted to the hospital for shortness of breath due to the inflammation of the intestines reducing space for the expansion of his lungs within the chest cavity. He discharged from the hospital under hospice care.,Not Reported,,Yes,Yes,,Not Reported,N,02/05/2021,02/26/2021,21.0,PHM,,,lymphoma,,"milk, bananas, corn","['Dyspnoea', 'Gastrointestinal inflammation']",1,MODERNA,IM 1063023,OH,44.0,F,"Left leg began hurting one hour after shot. Throat started to swell causing increased clearing of throat, swollen glands, with difficulty swallowing. Throat, esophagus was swollen 5 hours later. Went to emergency room and was given Benedryl, Epinephrine, Pepcid, and Solumedrol. Kept in ER for 8 hours, Throat still swollen, but better, provided second doses of Benedryl and Epinephrine, then admitted for observation for 24 hours. Throat and swallowing difficulties continued for approximately 3 days after discharge. Hoarseness, difficulty swallowing, having to push liquids and food into diaphram was uncomfortable.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/12/2021,02/12/2021,0.0,PUB,Atenelol 25 MG Celexa 20MG,Diabetes High Blood Pressure Depression/Anxiety,High Blood Pressure Depression/Anxiety,,Sulfa and Lisinopril,"['Blood creatinine decreased', 'Blood glucose increased', 'Blood sodium', 'Diaphragmalgia', 'Dysphagia', 'Dysphonia', 'Lymphadenopathy', 'Oesophagitis', 'Pain in extremity', 'Pharyngeal swelling', 'Throat clearing', 'White blood cell count increased']",2,MODERNA,IM 1063025,MD,63.0,F,"Low grade fever (100.3) after one week with progressive weakness, fatigue and swallowing dysfunction analogous to exacerbation of her autoimmune disease (LUPUS) which had been in remission (on medication) for 5 years.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/09/2021,02/25/2021,16.0,OTH,Prednisone 7.5 mg/day Celcept 2000mg/day Nexium 40mg/day,None,Systemic Lupus Erythematosus Polymyositis GERD,,"Heparin, Azithromycin, Dexilant, Penicillin","['Asthenia', 'Blood creatine phosphokinase increased', 'C-reactive protein increased', 'Condition aggravated', 'Dysphagia', 'Fatigue', 'Pyrexia', 'Red blood cell sedimentation rate increased', 'Systemic lupus erythematosus', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1063077,CA,74.0,F,Pt presented to hospital via ambulance with cardiac arrest after a CC of SOB. Pts sister who spoke with her two days ago stated she was in normal state of health and just got her 2nd dose of the covid vaccine. Unknown which manufacturer.,Not Reported,,Yes,Yes,,Not Reported,U,02/27/2021,02/28/2021,1.0,PVT,"ASA 81mg, Atorvastatin 40mg, Lasix 20mg BID, Lisinopril 5mg, Metoprolol XL 25mg, Nitroglycerin Acetaminophen, Albuterol Inhaler, B complex Vitamine, Calcium Carbonate, Vitamin D, Claritin, Ketoconazole 2% cream, Nystatin Powder, triamcinolo",,"Hypertension, aortic stenosis s/p TAVR, PH Class II, Obesity, frequent epistaxis",,,"['Cardiac arrest', 'Dyspnoea', 'Electrocardiogram', 'Laboratory test']",UNK,PFIZER\BIONTECH, 1063124,OH,36.0,M,Acute myocarditis after 2nd vaccine dose,Not Reported,,Yes,Not Reported,,Not Reported,,01/27/2021,02/12/2021,16.0,PVT,no,No,no,,NKA,['Myocarditis'],2,MODERNA, 1063163,OH,34.0,F,Saw OB on Jan 4 and there was a strong heartbeat and no defects or problems noted in any bloodwork up to that point in the pregnancy. Received my second vaccine on Jan 19. On Feb 3 I went to my next ultrasound appointment and was told that the baby had no heartbeat. It was estimated that the baby had likely passed a couple weeks prior but I am not certain of the timeline in regards to receiving the second vaccine.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/19/2021,02/03/2021,15.0,PVT,"PRENATAL, VITAMIN D, B COMPLEX",,"ANXIETY, MIGRAINES, IBS",,,"['Exposure during pregnancy', 'Foetal death', 'Foetal heart rate abnormal', 'Ultrasound antenatal screen abnormal', 'Ultrasound foetal abnormal']",2,MODERNA,IM 1063195,WA,59.0,F,"Onset of severe nausea, emesis, and bloody diarrhea, requiring hospitalization for 8 days, infusion care for 4 days after discharge due to hypokalemia, and resulting in diagnosis L ischemic colitis and hypokalemia.",Not Reported,,Not Reported,Yes,9.0,Not Reported,N,02/08/2021,02/10/2021,2.0,WRK,synthroid 100mcg no other medications,None,Excema Hashimotos Disease,,"Vicodin Iodine contrast Plastics, tapes Latex contact only","['Biopsy colon', 'Clostridium test negative', 'Colitis', 'Colitis ischaemic', 'Colonoscopy', 'Computerised tomogram abdomen abnormal', 'Diarrhoea haemorrhagic', 'Hypokalaemia', 'Laboratory test', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,SYR 1063201,TX,62.0,M,"The recipient was feeling well immediately after the vaccination, all day on 2.8 and in the morning of 2.9. His daughter in law text him at 0930 and he did not respond to the text (atypical) and then he missed a morning meeting. His wife was downstairs in a meeting herself and after the meeting was over she called to him and he did not respond. She found him with no pulse and was not breathing. She called 911 and attempted CPR. They did not complete an autopsy, they stated that they believe the cause of death was either an embolism, Heart attack or aneurism. The wife stated that she does not believe the death was due to the vaccination; however, there were no tests completed to prove or disprove.",Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/09/2021,1.0,WRK,Naproxen Beta blocker- unsure of name Flomax,no other illnesses,High Blood pressure enlarged prostate,,No known allergies,"['Death', 'Pulse absent', 'Respiratory arrest']",2,PFIZER\BIONTECH,IM 1063243,NY,36.0,F,"Headache , Dizziness, unsteadiness, diploplia, blurry vision started 1 week after second dose",Not Reported,,Not Reported,Yes,,Not Reported,N,01/20/2021,01/28/2021,8.0,PVT,,,,,,"['Balance disorder', 'Diplopia', 'Dizziness', 'Headache', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging neck', 'Vision blurred']",2,PFIZER\BIONTECH,IM 1063283,,80.0,M,"Admitted to hospital on 2/28/21 for covid pneumonia and acute hypoxic respiratory failure, covid test positive. receiving dexamethasone 6 mg BID and received 1 dose of actemra. concern for bacterial infection.",Not Reported,,Not Reported,Yes,,Not Reported,,02/16/2021,02/28/2021,12.0,UNK,,,,,,"['COVID-19 pneumonia', 'Respiratory failure', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1063290,SD,76.0,M,"Patient started to not feel well on 2/21/2021. Symptoms progressed throughout the week. Patient was seen for a clinic appointment 2/26 and was then admitted to the hospital. Patient complains of generalized weakness, body aches, fever, chills, cough and increased shortness of breath at rest and with activity. He was diagnosed with Pneumonia due to COVID-19 infection and started on oxygen, dexamethasone and remdesivir.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/08/2021,02/26/2021,18.0,PVT,,,"Type 2 Diabetes, chronic kidney disease, hypertension, coronary atherosclerosis and hyperlipidemia",,,"['Asthenia', 'COVID-19', 'COVID-19 pneumonia', 'Chills', 'Cough', 'Dyspnoea', 'Malaise', 'Pain', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1063305,WI,91.0,M,"Patient presented to Medical Center on 02/23/2021 for weakness and fall. Patient had received his 1st Moderna COVID-19 vaccine on 02/22/2021. Was weak unable to rise out of the chair the next day. Patient has a history of COVID-19 in November of 2020. Patient was admitted to the hospital on 02/23/2021. Patient was ultimately diagnosed with generalized weak, right knee pain status post fall and elevated troponin level. Patient was managed conservatively and recovered over 24 hours. Patient was discharged on 02/24/2021 to follow-up.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/22/2021,02/23/2021,1.0,PVT,levothyroxine 75 MCG tablet traZODone (DESYREL) 50 MG tablet melatonin 5 MG ASPIRIN 81 PO Ferrous Sulfate (IRON PO) allopurinol (ZYLOPRIM) 300 MG tablet amLODIPine (NORVASC) 5 MG tablet dutasteride (AVODART) 0.5 MG capsule omeprazol,None known.,"Benign prostatic hyperplasia with urinary obstruction Hyperactive airway disease Essential hypertension GERD Gout Insomnia secondary to depression with anxiety Depression Hypothyroidism DJD (degenerative joint disease), multiple sites Right knee DJD H/O hiatal hernia DJD (degenerative joint disease) of cervical spine Coronary Artery Disease Diverticulosis of colon Internal hemorrhoids Hyperlipidemia LDL goal < 100 Stage III chronic kidney disease (CMS/HCC) Left hip pain /Advanced DJD hip[719.45] Left shoulder pain Degenerative arthritis of left shoulder region CKD (chronic kidney disease) stage 3, GFR 30-59 ml/min (CMS/HCC) SCC (squamous cell carcinoma), face Severe aortic stenosis LVH (left ventricular hypertrophy) History of 2019 novel coronavirus disease (COVID-19)",,Levaquin,"['Arthralgia', 'Asthenia', 'Fall', 'Mobility decreased', 'Troponin increased']",UNK,MODERNA, 1063331,FL,63.0,F,Acute Pancreatitis,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/30/2021,02/07/2021,8.0,PUB,,none,MS,,"sulfa, baclofen, amitriptyline","['Computerised tomogram', 'Lipase increased', 'Magnetic resonance imaging', 'Pancreatitis acute']",UNK,MODERNA, 1063363,WY,,F,"cellulitis; A regulatory report was received from a Non-Health Professional on 16Feb2021, which refers to a 87-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis. The patient's medical history was not provided. No relevant concomitant medications were reported. On 19Jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 027L20A) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection. On 19Jan2021, the patient experienced cellulitis. As a result, she was hospitalized on 11Feb2021 and then again on 15Feb2021. She was treated with antibiotic IV infusion. The Non-Health Professional did not declare any relatedness between cellulitis and Moderna COVID-19 Vaccine.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/19/2021,02/11/2021,23.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Cellulitis'],1,MODERNA,OT 1063364,NJ,70.0,F,"peripheral neuropathy with no feeling in her toes, feet and up to her waist; tremors to the 5th digits to bilateral hands; imbalanced gait; severe upper back pain; Severe neck pain; transverse myelitis with significant involvement; A spontaneous report was received from a physician concerning a 70-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced transverse myelitis with significant involvement, peripheral neuropathy with no feeling in her toes, feet and up to her waist, upper back pain, neck pain, tremors to the 5th digits to bilateral hands, and imbalanced gait. The patient's medical history included breast cancer. No relevant concomitant medications were reported. On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. On 10 Feb 2021, the patient began to experience severe upper back and neck pain. The patient's pain progressed to peripheral neuropathy with no feeling in her toes and feet, and up to her waist. She also had tremors to the 5th digits in both hands. On 12 Feb 2021, the patient was admitted to the hospital. The patient had transverse myelitis with significant involvement. She had an imbalanced gait and had involvement from C3-7 and T1. She was taking high doses of steroids- Dexamethasone 10mg/day. It is believed the patient had an exacerbated autoimmune reaction and that she will require surgical repair. Action taken with mRNA-1273 in response to the events was not provided. The outcomes of the events were not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Yes,U,01/28/2021,02/10/2021,13.0,UNK,,,"Medical History/Concurrent Conditions: Breast cancer (She also has a history of breast cancer, but that was many years ago.)",,,"['Back pain', 'Gait disturbance', 'Myelitis transverse', 'Neck pain', 'Neuropathy peripheral', 'Tremor']",1,MODERNA,OT 1063426,OH,47.0,M,"Severe right Bell's Palsy, Outcome to be determined.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/28/2021,02/27/2021,30.0,PVT,"Pravastatin, Omeprazole, Complete Multi-Vitamin",None,Hyperlipidemia,,NKDA,"['Computerised tomogram head', 'Facial paralysis', 'Full blood count', 'Magnetic resonance imaging brain', 'Metabolic function test']",2,MODERNA,SYR 1063457,MA,63.0,M,"On date on second dose, 2/27/2021, the pt began have fatigue and diarrhea at around 10:30 am. This continued to the following day. On 2/28/2021, the patient was last seen around 4:20 pm by his wife in their residence. She found him unresponsive at 5:30 pm in their bedroom. EMS was called and the decedent was declared deceased. The pt had his first dose on 2/9/2021. Both doses were given at the hospital. Per family, the pt had no adverse affects following the first dose.",Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,02/27/2021,02/28/2021,1.0,MIL,Unknown,PTSD,PTSD,,Unknown,"['Death', 'Diarrhoea', 'Fatigue', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 1063461,NC,73.0,M,"Episodes (seizure-like appearance), left arm and leg muscle tension/contraction (clutching of hand, raising of leg), leftward face contortion, extreme pain along entire left side. Periodicity: many events some days (at least 11 events on one day), some days (even a few in a row) no events. Examination for stroke and heart attack were negative. Initial diagnosis of faciobrachial dystonia, followed by negative laboratory blood-test confirmation of diagnosis. No current diagnosis. Several rounds of treatment by IV steroid and oral steroid.",Not Reported,,Not Reported,Yes,7.0,Yes,N,01/16/2021,01/27/2021,11.0,OTH,"Lotrel, aspirin, lipitor, plavix, lantus, jardiance, metformin, liraglutide",,"Type II diabetes, high blood pressure, high cholesterol",,,"['Blood test normal', 'Dystonia', 'Muscle contractions involuntary', 'Muscle tightness', 'Pain', 'Seizure like phenomena']",1,PFIZER\BIONTECH,IM 1063464,MA,55.0,M,"Patient had the first dose of the Pfizer COVID vaccine (LOT# EL9264) on 1/29/21 at the vaccination center at Medical Center (set up in Hotel). He had the second dose on 2/19/21 (LOT# EN6201) at 12:30pm, and reported leg pain and difficulty breathing on 2/26/21 as he was going to bed. He presented to the ER at Hospital that day, and was diagnosed with a deep venous thrombosis and pulmonary embolism. He is currently taking Xarelto, and will schedule an appointment with Hematology, as he has no family or personal history of clotting disorder.",Not Reported,,Yes,Yes,,Not Reported,N,02/19/2021,02/26/2021,7.0,UNK,Amlodipine Besylate 2.5 MG Tablet 2 tablets Orally Once a day Atorvastatin Calcium 20 mg Tablet 1 tablet Orally Once a day Famotidine 20 MG Tablet 1 tablet at bedtime as needed Orally Once a day Ferrous Gluconate 324 (38 Fe) MG Tablet 1,None,"Living-donor kidney transplant recipient CKD stage G2/A1, GFR 60-89 and albumin creatinine ratio <30 mg/g HTN (hypertension) Hyperlipidemia, unspecified hyperlipidemia type Hyperkalemia Gout Iron deficiency Condyloma acuminata Gastroesophageal reflux disease, esophagitis presence not specified",,None,"['Deep vein thrombosis', 'Dyspnoea', 'Pain in extremity', 'Pulmonary embolism']",2,PFIZER\BIONTECH,IM 1063479,MI,59.0,M,"Patient received covid shot, was sitting in chair after shot, felt sudden urge to have BM, stood up and passed out. Bradycardia (Per ems reading of 58 and then 41, current in hospital 62), and Hypotension (Per ems 88/64 and then 68/42) � He was required to stay for 15 mins afterward for symptom monitoring. He then proceeded to feel ill after the vaccine, became sweaty, lightheaded, and felt gassy. He then stood up to use the restroom, and stated he felt he was going to pass out and fell to the ground, hitting his head against the ground. He denies any full LOC. Did sustain a laceration to L forehead. He denies any preceding vertigo, chest pain, or DIB.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/28/2021,02/28/2021,0.0,PHM,aspirin atorvastatin metoprolol pantoprazole ticagrelor,None,GERD Hypertension Coronary artery disease,,None,"['Bradycardia', 'Defaecation urgency', 'Dizziness', 'Fall', 'Flatulence', 'Head injury', 'Hyperhidrosis', 'Hypotension', 'Loss of consciousness', 'Malaise', 'Skin laceration']",1,MODERNA,IM 1063483,,77.0,F,"Admitted to hospital on 1/28/21 from nursing home with altered mental status and UTI. PMH of heart failure, CKD, afib, COPD. discharged on 2/2/21. COVID negative during this admission. Readmitted on 2/28/21 for AMS, family was unable to wake patient up for an hour prior to calling EMS. Upon admission, found COVID positive.",Not Reported,,Not Reported,Yes,,Not Reported,,01/27/2021,01/28/2021,1.0,PVT,,,,,,"['COVID-19', 'Mental status changes', 'SARS-CoV-2 test positive', 'Urinary tract infection']",1,PFIZER\BIONTECH, 1063485,CA,53.0,F,"First muscle soreness at site of injection, then severe redness at site, cherry electric red and pink, severe muscle aches, severe joint aches, severe headache, diarreah, dizzyness, the extreme rapid heart rate of 205 BPM. SEVERE SVT, SUPREVENTRICULAR TACHYCARDIA lasting from 9 p.m. Friday evening through the a.m. until I was transported from Urgent Care via Paramedics to Emergency Hospital. I was given an IV of a Medicine to restart my heart twice. I felt like I was dying.",Not Reported,,Yes,Yes,,Not Reported,N,02/25/2021,02/26/2021,1.0,PVT,tamoxifen,none,Chrohn's disease,,orange juice zilactin,"['Arthralgia', 'Blood creatine', 'Blood creatine phosphokinase', 'Blood glucose', 'Blood magnesium', 'Blood potassium', 'Blood sodium', 'Blood thyroid stimulating hormone', 'Cardiac arrest', 'Diarrhoea', 'Dizziness', 'Electrocardiogram', 'Haematocrit', 'Haematology test', 'Haemoglobin', 'Headache', 'Heart rate increased', 'Injection site erythema', 'Injection site pain', 'Mean cell haemoglobin', 'Mean cell haemoglobin concentration', 'Mean cell volume', 'Mean platelet volume', 'Myalgia', 'Nucleated red cells', 'Platelet count', 'Red blood cell count', 'Red cell distribution width', 'Supraventricular tachycardia', 'Troponin', 'White blood cell count']",1,PFIZER\BIONTECH,IM 1063522,MI,71.0,M,1. Fatigue ? day 1 - Tuesday 2. Loss of appetite ? day 1 Tuesday 3. Fever 102.0 ? day 2 - Wednesday 4. Chills ? day 2 - - Wednesday 5. Weak ? day 2 - - Wednesday 6. Non-ambulatory (unusual) ? day 2 - - Wednesday 7. Two emergency service ambulance assessment ? day 2 - - Wednesday 8. Symptoms improved ? day 3 - Thursday 9. Ambulatory - day 3 - Thursday 10. Symptoms worsened ? day 4 - Friday 11. Chills ? day 4 - Friday 12. Non-ambulatory again ? day 4 - Friday 13. Fever 102.0 ? day 4 - Friday 14. Left side flank pain ? day 4 - Friday 15. CPR and declared decease at home by paramedics - day 5 - Saturday morning @ 1:32am,Yes,02/27/2021,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/23/2021,0.0,OTH,1. Xarelto 20mg 2. Digoxin 125mcg 3. Aterbastatin 10mg 4. Escitalopram 10mg 5. Lopressor 50mg 6. Spironolactone 25mg 7. Lasix 20mg 8. Gabapentin 200mg 9. Diazepam 5mg 10. Lisinopril 2.5mg 11. Tylenol 800mg 12. Breoellieta 200/25 13. Spiriva,No new or acute illnesses reported within the last month,1. Multiple myeloma 2. Atrial Fibrillation 3. COPD ? Emphysema/Asthma 4. Congested Heart Failure 5. Macular degeneration 6. Normal Sp02 ? 90%-92%,,1. Entresto,"['Asthenia', 'Blood glucose', 'Chills', 'Death', 'Decreased appetite', 'Electrocardiogram', 'Fatigue', 'Flank pain', 'Gait inability', 'Pyrexia', 'Resuscitation']",1,PFIZER\BIONTECH,IM 1063525,UT,74.0,F,"Takotsubo Cardiomyopathy, Acute Pulmonary Edema, Hospital Admission, Diuresis.",Not Reported,,Yes,Yes,9.0,Not Reported,N,02/24/2021,02/24/2021,0.0,PVT,"aspirin 81 mg oral delayed release tablet 81 mg = 1 tabs, Oral, Daily BD Ultra-Fine Pen Needle Nano 32G 4 mm (5/32 inch) 1 EA, PRN, N/A, As Directed Dexilant 60 mg oral delayed release capsule 1 cap, Oral, every morning doxazosin 2 mg or","CAD, lymphedema, OSA, DM2, HLD, obesity",see above,,"ACE inhibitors, amoxicillin, atorvastatin, codeine, losartan, nitrofurantoin, PCN, pravastatin, prochlorperazine, sulfa, verapamil","['Acute pulmonary oedema', 'Chest X-ray abnormal', 'Echocardiogram abnormal', 'Polyuria', 'Stress cardiomyopathy', 'Troponin increased']",2,MODERNA,IM 1063538,MN,81.0,M,Patient developed significant nose bleed after receiving vaccine. Required emergency department visits x2 and hospitalization.,Not Reported,,Not Reported,Yes,2.0,Not Reported,,02/25/2021,02/25/2021,0.0,PUB,,,,,,['Epistaxis'],2,PFIZER\BIONTECH,IM 1063555,CT,33.0,F,"2/5- administered 2nd Moderna vaccine dose. 2/6-chills, body aches and pains, arm pain and welt, alternated Tylenol and Motrin q4 around the clock. 2/7-2/8 rested and was off of work (no symptoms- felt fine) 2/9- returned to work, passed safepass and while on zoom call at 9am developed wheezing and cough and slight low grade temp (99.5). Took symbicort (I have normally well controlled asthma). Called clinic and was advised that I was fine and could continue to work and to follow up with MD if symptoms got worse. Did virtual visit with Pulmonologist at 0945 and he advised me to get COVID swabbed and prescribed prednisone taper and albuterol MDI. COVID swabbed 2/9 at 5pm. Out of work 2/10 & 2/11 awaiting test results. Returned to work 2/12 after negative COVID result- passed safepass- worked, still SOB, but manageable. 2/13-2/14 had increasing SOB- albuterol MDI 6x/day. Monday 2/15 returned to work- saw doctor in person- increased prednisone from 20mg (tapered down) to 40mg (original dose) and added Spiriva. 2/17- Went to ED for status asthmaticus after using albuterol MDI 5-6x/day without any relief. Admitted 2/17 for asthma exacerbation- discharged 2/20. Discharged home with nebulized albuterol, prednisone slow taper, symbicort, Spiriva, Singulair & Claritin. 2/23-2/24 Albuterol nebs 5x/day, still SOB. Pulmonary visit 2/24 - added inhaled budesonide nebs. Out of work 2/25-2/26. Returned to work 3/1- finally feeling better!",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/05/2021,02/09/2021,4.0,PVT,,,Asthma (normally well controlled),,Meperidine - anaphylaxis Bactrim - hives,"['Chills', 'Condition aggravated', 'Cough', 'Dyspnoea', 'Impaired work ability', 'Pain', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test negative', 'Status asthmaticus', 'Urticaria', 'Wheezing']",2,MODERNA,IM 1063561,IL,92.0,F,"Patient was a Resident on our LTC wing. Per the LTC Manager: Resident had hx of CVA with deficits in speech and extremities. Hx of decreased circulation to BLE's which resulted in wounds to bilateral feet on and off that needed treatment. Average meal consumption 25-50% of meals, started refusing more often in December and January. Would consume small amounts 60-120mL of fluids here or there. Vaccinated on 1/7/21. Stopped eating 1/18/21. Attempted bolus NS fluid 1/25/21. Resident refused all treatment afterwards. Went hospice on 2/3/21 and passed away on 2/7/21.",Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,02/07/2021,31.0,PVT,,"Resident had hx of CVA with deficits in speech and extremities. Hx of decreased circulation to BLE's which resulted in wounds to bilateral feet on and off that needed treatment. Decreased oral Intake. Average meal consumption 25-50% of meals, started refusing more often in December and January. Would consume small amounts 60-120mL of fluids here or there.","CVA, Decreased circulation to BLE, Decreased oral intake",,Lisinopril,"['Death', 'Diet refusal']",1,MODERNA,IM 1063574,TX,66.0,M,STROKE LIKE SYSTEMS /FATIGUE/ WEAKNESS IN LEG AND ARM JOINTS/LOS OF BALANCE/ DELIRIUM.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/27/2021,02/27/2021,0.0,UNK,ARORVASTATIN 40 MG CLOPDOGREL 75 MG LISINOPRIL-HCTZ 20/25 MG BICALUTAMIDE 50 MG LUPRON INJECTION ONE A DAY VITIMINS,PROSTATE CANCEL 3 YEARS AGO STROKE 5 MO AGO,,,,"['Balance disorder', 'Delirium', 'Fatigue', 'Muscular weakness', 'Neurological symptom']",UNK,MODERNA, 1063602,VA,39.0,F,"developed sharp left chest pain, fever, chills. Felt better with acetaminophen. On 2/27/2021 left chest pain returned and was so severe caused hospital ED visit and hospital admission",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/24/2021,02/24/2021,0.0,PVT,"none. did take acetaminophen at onset of symptoms (chest discomfort, fever, chills)",none,none,,Penicillin-intolerance,"['Angiogram pulmonary normal', 'Chest X-ray', 'Chest pain', 'Chills', 'Echocardiogram', 'Laboratory test', 'Pyrexia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,IM 1063604,MI,71.0,F,Patient presented to Hospital via EMS secondary to a fall outside where she fell of her hands and knees complaining of weakness and unable to get self up.,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/26/2021,02/27/2021,1.0,PVT,,unknown,"Anemia; Chronic Back Pain, Diabetes, Fibromyalgia, Acid Reflux, Cardiac murmur, Hypertension, Hypothyroidism, Migraines, Neuropathy, Sick Sinus Syndrome, TMJ",,"Lisinopril, Morphine, Losartan","['Asthenia', 'Brain natriuretic peptide', 'Cardioactive drug level', 'Chest X-ray', 'Computerised tomogram head', 'Computerised tomogram spine', 'Dysstasia', 'Electrocardiogram', 'Fall', 'Laboratory test', 'Laboratory test', 'Troponin', 'Urine analysis', 'X-ray of pelvis and hip']",2,PFIZER\BIONTECH,IM 1063644,MT,84.0,M,"Pt called for Dose 2 appointment. Contracted COVID right after Dose 1 Moderna Vaccine. Hospitalized 2/08/2021. Discharged 2/10/2021. Admitted with nausea, diarrhea, lightheadedness, and weakness. Pt treated for Covid-19 Infection with GI symptoms, Acute Kidney Injury, Leukocytosis",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/22/2021,02/08/2021,17.0,PVT,UNknown,unknown,"DM Type 2, HTN, NSTEMI, GERD",,Latex?,"['Acute kidney injury', 'Asthenia', 'Blood creatine phosphokinase', 'Blood magnesium', 'C-reactive protein', 'COVID-19', 'Diarrhoea', 'Differential white blood cell count', 'Dizziness', 'Full blood count', 'Gastrointestinal disorder', 'Leukocytosis', 'Metabolic function test', 'Nausea']",1,MODERNA,IM 1063674,MI,68.0,M,EMS responded to a call at his home; he was found unresponsive by family slumped over in a chair,Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/21/2021,16.0,PVT,unknown he did not doctor,unknown,diabetes,,unknown,['Unresponsive to stimuli'],1,PFIZER\BIONTECH,IM 1063681,NV,75.0,M,Pt got his vaccine 1/27 and was found dead at his residence on 2/7/21. I heard from our county health officer who talked to the coroner who said that they estimated that the patient had been deceased for 2-3 days prior to when they were found. No apparent cause of death was found.,Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/04/2021,8.0,PVT,"Triam/HCTZ, Omeprazole",none,"Mild hypertension, GERD",,none,['Death'],1,MODERNA,IM 1063702,IL,85.0,M,"24 hours later : left-sided facial droop, limb ataxia bilaterally, and mild to moderate dysarthria.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/27/2021,02/28/2021,1.0,PVT,acetaminophen (TYLENOL) 325 MG Tablet aspirin 81 MG PO CHEW carbidopa-levodopa (SINEMET) 25-100 MG Tablet donepezil (ARICEPT) 5 MG Tablet escitalopram (LEXAPRO) 10 MG Tablet finasteride (PROSCAR) 5 MG Tablet meclizine (ANTIVERT) 12.5 MG Tab,none known,"Aortic valve stenosis, mild 1 year ago Chronic heart failure with preserved ejection fraction (HCC) 1 year ago HTN (hypertension) 1 year ago Left ventricular hypertrophy Unknown Mixed hyperlipidemia 1 year ago Nervous Acute encephalopathy 1 year ago Acute ischemic right MCA stroke (HCC) Yesterday Bilateral carpal tunnel syndrome 1 year ago Cubital tunnel syndrome, bilateral 1 year ago Dysarthria due to acute stroke (HCC) Yesterday Facial droop due to acute stroke (HCC) Yesterday Parkinson's disease (HCC) Unknown Peroneal muscle atrophy",,none,"['Angiogram cerebral normal', 'Arteriogram carotid normal', 'Ataxia', 'Cerebral small vessel ischaemic disease', 'Computerised tomogram head normal', 'Dysarthria', 'Facial paralysis', 'Intensive care']",1,PFIZER\BIONTECH,IM 1063711,NJ,50.0,F,2-3 asthma attacks per day,Not Reported,,Yes,Not Reported,,Not Reported,N,02/25/2021,02/25/2021,0.0,UNK,Vitamin D Vitamin C Magnesium,None,Sleep apnea Mild asthma,,Penicillin Strawberries Cranberries Some molds Wheat sensitivity,"['Asthma', 'Condition aggravated']",1,PFIZER\BIONTECH,SYR 1063715,IL,81.0,M,"Patient has history of COVID19 infection on November 2020. He received first dose of pfizer COVID 19 vaccine on 2/2/21. Six days later on 2/8/21, the patient presented to the ED with complaints of cough, dyspnea, and vomiting. Patient was breathing on room-air, blood pressure was stable, and he wasn't febrile. Patient was admitted for bilateral pneumonia. Initial COVID test on 2/9/21 was negative and patient received 7 days of antibiotic therapy. Throughout the patient's stay, his respiratory function was stable on room air. Patient was to be discharged at the end of the antibiotic therapy but a follow-up COVID PCR test on 2/17 resulted POSITIVE. Patient's s/s for infection were already improving and the providers held off on discharging to be sure the patient was asymptomatic for COVID 19. Patient was uneventfully discharged on 2/26/21 for a total stay of 18 days.",Not Reported,,Not Reported,Yes,18.0,Not Reported,Y,02/02/2021,02/08/2021,6.0,PVT,Amlodipine tablets - 2.5mg PO QD Aspirin tablets - 81mg PO QD Atorvastatin tablets - 40mg PO QD Cinacalcet tablets - 30mg PO QD Clopidogrel tablets - 75mg PO QD Insulin glargine - 10 units SubQ QHS Phenytoin capsules - 300mg PO TID Sevelame,None,End-stage renal disease with dialysis Hypertension Hyperlipidemia Left carotid artery stenosis History of stroke Diabetes mellitus,,Povidone-iodine (itching),"['COVID-19', 'Computerised tomogram thorax abnormal', 'Cough', 'Dyspnoea', 'Influenza virus test negative', 'Lung opacity', 'Pneumonia', 'SARS-CoV-2 test positive', 'Vomiting']",1,PFIZER\BIONTECH,IM 1063722,MS,65.0,F,"On 2/28/21 @ Co vaccination drive thru pt received 2nd dose moderna vaccine im right deltoid. approx 5min after administration pt reports rash and edema to left arm. redness and edema noted to left forearm inner aspect. localized to this area alone. pt denies other s/sx. (on assessment pt states she had non specific allergies as a child.) Benadryl was administered per dh standing orders. pt remained additional 20min and w/o further concerns. On 3/1/21 phoned pt for f/u. pt states she is doing fine. no further problems following event. pt states she is not certain this was related to vaccine, states prior to arriving to receive vaccination she was dining outside at a restaurant and might have been bite by insect. inst pt to call if she has any further questions/concerns. pt vu.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/28/2021,02/28/2021,0.0,PUB,unk,none,none reported,,nka,"['Oedema peripheral', 'Rash']",2,MODERNA,IM 1063727,MT,79.0,M,Called pt for Dose 2 appt. Pt had passed away.,Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,02/23/2021,33.0,PVT,unknown,dementia,dementia,,unknown,['Death'],1,MODERNA,IM 1063758,OH,61.0,M,"Patient died on 2/25/21 in the AM after receiving his COVID-19 Moderna vaccine #1 at approximately 2:30P on 2/24/21. I do not have a time of death. I contacted the County Medical Examiner's office who stated that they received his body after he was determined to be deceased at the shelter. No autopsy was performed and his body was released to a funeral home on 2/26. The ME's office said that ""permit for burial/cremation is pending"" and no other information on COD was available. Per staff, he was also tested for COVID as part of shelter protocol on 2/24 and PCR was negative. He arrived to the shelter on 2/19/21.",Yes,02/25/2021,Not Reported,Not Reported,,Not Reported,N,02/24/2021,02/25/2021,1.0,OTH,unknown,unknown,Fully treated for TB many years ago,,unknown,"['Death', 'SARS-CoV-2 test negative']",1,MODERNA,IM 1063812,IL,79.0,M,"Resident had severe CAD, DM type 2, and hx of RBKA and left 5 digits on foot amputation. Hx of osteomyelitis post surgical. After last surgery, resident did not have a good appetite, more restless, increased confusion with dementia. Significant other passed away on 12/30/20, resident began refusing meals, decreased eating. Vaccinated on 1/13/21. On 1/25/21 Resident labs showed kidney failure. Dr. spoke with family and transitioned to Comfort care, on 2/5/21 went hospice. Patient passed away on 2/13/2021.",Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/13/2021,0.0,PVT,,"severe CAD, DM type 2, and hx of RBKA and left 5 digits on foot amputation. Hx of osteomyelitis post surgical. Decreased appetite, more restless, increased confusion with dementia, On 1/25/21 Resident labs showed kidney failure, on 2/5/21 went on comfort care","severe CAD, DM type 2, and hx of RBKA and left 5 digits on foot amputation. Hx of osteomyelitis post surgical.",,Doxycycline,"['Confusional state', 'Death', 'Dementia', 'Diet refusal', 'Laboratory test abnormal', 'Renal failure', 'Restlessness']",1,MODERNA,IM 1063835,NE,102.0,F,"Pt. received her 1st Moderna Covid vaccine on 1/28/2021 with lot number of 010M20-A at 0906 am. Family reports since the first vaccine pt. has had weakness and has fallen. Pt. received her 2nd Moderna vaccine on 2/24/2021; see information above for lot, etc. Pt. was brought into ER with c/o falls, weakness and confusion. Pt. had fallen on 2/27 and 2/28. With one of the falls pt. fx. her right radius and ulna. PCP due to altered mental status, right sided weakness and aphasia at times is r/o stroke.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/24/2021,02/28/2021,4.0,PVT,"Multivitamin, Lisinopril, Diltiazem, Restasis",Denies any illness at time of the vaccination. Pt. did receive her 1st Covid vaccine on 1/28/2021 and family reports that pt. has had weakness and falls since the first vaccine.,"Due to recent fall pt. fx. her right radius and ulna; Hx. of pubic ramis fx; lumbar and sacral osteoarthritis; compression fx. of L4; CAD, dx. with right sided weakness - r/o stroke on 2/28/2021.",,NKA,"['Aphasia', 'Asthenia', 'Cerebellar atrophy', 'Cerebral atrophy', 'Cerebral infarction', 'Computerised tomogram head abnormal', 'Confusional state', 'Dysarthria', 'Fall', 'Hemiparesis', 'Mental status changes', 'Radius fracture', 'Ulna fracture']",2,MODERNA,SC 1063846,IL,91.0,F,"Hx dementia, CVA, CAD. 2-3 year history of only consuming 25% of 1-2 meals daily. All meds d/c early 2020 because of refusing to eat or drink anything. Suddenly began drinking april/may, gained weight back. Vaccinated on 1/7/21 & 2/4/21. On 2/22/21 had significant changes in respiratory status. Passed away 2/23/21.",Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/22/2021,18.0,PVT,,"Hx dementia, CVA, CAD. 2-3 year history of only consuming 25% of 1-2 meals daily","Hx dementia, CVA, CAD. 2-3 year history of only consuming 25% of 1-2 meals daily",,NKA,"['Death', 'Decreased appetite', 'Hyperphagia', 'Respiration abnormal', 'Weight increased']",1,MODERNA,IM 1063860,MI,51.0,F,"Pt presented to the ED in acute anaphylaxis 20 minutes after receiving vaccine dose, in respiratory distress with stridor, wheezing, and difficulty breathing, as well as hives across her chest and arms. Pt had Epipen with her and ED staff assisted her in administering it. Pt received solu-medrol, pepcid, benadryl, and albuterol in the ED. Pt significantly improved within 1 hour and was admitted to the hospital to be monitored overnight.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/24/2021,02/24/2021,0.0,PVT,"lipitor, prenatal 27-1mg tabs, xarelto, albuterol, flexeril, diflucan, ambien, valtrex, xanax, singulair, tylenol, calcium citrate-vitamin D, vitamin D, cymbalta, allegra, hizentra, magnesium oxide, prilosec, zofran, vitamin B12",,"breast mass, colon polyps, gastritis, GERD, hyperlipidemia, hypogammaglobulinemia, IBS, immune deficiency disorder, osteoarthritis, recurrent sinus infections",,"bactrim, blood root, ceftin, tree nuts, kiwi fruit, sulfa drugs, trimethoprim, COVID-19 vaccine (added 2/24/2021)","['Anaphylactic reaction', 'Blood alkaline phosphatase increased', 'Blood alkaline phosphatase normal', 'Blood glucose increased', 'Chest X-ray normal', 'Dyspnoea', 'Neutrophil percentage increased', 'Platelet count increased', 'Red blood cell count decreased', 'Respiratory distress', 'Stridor', 'Urticaria', 'Wheezing', 'White blood cell count increased']",2,MODERNA,IM 1063862,PA,53.0,M,Bell?s palsy,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/21/2021,02/26/2021,5.0,PVT,Copaxone Imuran,None,MS,,None,"['Facial paralysis', 'Magnetic resonance imaging']",UNK,MODERNA, 1063863,IL,85.0,M,"Resident had Hx of DM T2, Hx of prostate CA. Started having swallowing difficulties in November. Increased c/o nausea and decreased appetite. 25% per meal average. Decreased energy to participate in activities and refused getting out of bed or meals. Was vaccinated on 1/13/21. Hospice care started on 1/25/21. Resident passed away 2/23/21.",Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,02/23/2021,41.0,PVT,,"Hx of DM T2, Hx of prostate CA. Started having swallowing difficulties in November. Increased c/o nausea and decreased appetite. 25% per meal average. Decreased energy to participate in activities and refused getting out of bed or meals.","Hx of DM T2, Hx of prostate CA. Started having swallowing difficulties in November. Increased c/o nausea and decreased appetite. 25% per meal average.",,"Penicillins- Hives/ Urticaria, Rash",['Death'],1,MODERNA,IM 1063882,WI,80.0,M,"Patient is an 80 year old male who has a history of multiple medical problems, including body mass index of 30, hypertension, dyslipidemia, giant-cell arteritis on a slow prednisone taper (currently 2 mg daily), past pulmonary embolism on warfarin, sleep apnea, history of diverticulitis (treated in August 2020), past abdominal surgeries (including umbilical hernia repair �2 and open recurrent incarcerated epigastric hernia repair with mesh in October 2020), chronic anemia, and type-2 diabetes. �The patient had received the first dose of the COVID-19 (SARS-CoV-2) vaccine on January 31, 2021 and the second dose on February 21. �He presented to his primary care provider?s office on February 22, 2021 with complaints of 10 days of progressive weakness and muscle soreness. �The weakness had reportedly involved the bilateral thighs and arms and was associated with muscle aches. �Blood pressure measured 90/40 mmHg and examination was notable for symmetrical proximal weakness in the upper and lower extremities. �The peripheral blood leukocyte count measured 3.5 x10e3/�L, hemoglobin 8.3 grams per deciliter and platelets 147 x10e3/�L. �A peripheral blood smear was consistent with neutropenia and normocytic anemia with 9% circulating blasts. �Total CK measured 1424 U/L. �The patient was referred to hematology/oncology and rheumatology and had appointment scheduled for both on February 26. � With�the above�background, he presented to emergency room on February 24 with altered mental status and continued weakness. �He was taken to the hospital by emergency medical services. �A temperature of 103 degrees Fahrenheit was recorded when emergency medical personnel had arrived.�The peripheral blood leukocyte count was 1.4 x10e3/�L for an ANC of 0.8 x10e3/�L. �Hemoglobin was 8.1 g/dL and platelets 111 x10e3/�L. �A few schistocytes and teardrop cells were noted. The serum creatinine was 1.47 mg/dL. �AST was 174, ALT 91 and alkaline phosphatase 93 U/L. �The lactic acid level of the venous blood was 2.1 mmol per liter. �A repeat total CK was 4631 U/L. �Sedimentation rate measured 34 mm/h and CRP 52.3 mg/L. �Urinalysis showed 0-2 wbc?s/hpf, 0-2 rbc?s/hpf, 3+ blood, negative nitrites, negative leukocyte esterase. �A haptoglobin level of the blood was within normal limits. The lactic acid level of the venous blood was 2.0 mmol/L. �LDH measured 838 U/L. �A ferritin level was 3464 nanograms/mL. �A test for COVID-19 (SARS-CoV-2) was negative. � � A chest radiograph showed minimal streaky right basilar atelectasis, trace left effusion and a mildly enlarged cardiac silhouette. �A head CT showed no acute abnormality. �An abdominopelvic CT without contrast was limited by motion artifact. �No acute intra-abdominal or pelvic finding was noted. �Nonspecific soft tissue stranding was seen in the right inguinal region. �There was no soft tissue gas or drainable fluid collection. �Cultures of specimens of the blood were obtained. �The patient was started on empiric cefepime, vancomycin and doxycycline and admitted for further care. A peripheral blood smear for intracellular parasites was negative. �The admission blood cultures came back positive for E. coli. With the blood culture results, the vancomycin and doxycycline were discontinued. �The E. coli isolate has since been determined to be pansusceptible. �A MRSA PCR of the nares was negative. � He was found on exam to have swelling, cellulitis and exquisite pain of the right groin area�on February 25. �Surgical consultation was pursued. �They did not feel that he had necrotizing fasciitis. �The CT scan of the abdomen and pelvis was repeated with contrast, revealing increased extensive subcutaneous edema of the right groin region with extension into the thigh musculature and mild extension into the right inferior pelvis. �There was no associated soft tissue gas or drainable abscess. A bone marrow biopsy was performed February 25. �Results showed acute undifferentiated leukemia with 60-70% infiltration of the bone marrow with blasts. The blasts were negative for lineage markers. He was faintly CD33 positive. He is felt to likely have acute myeloid leukemia. Cytogenetics are pending. � �",Not Reported,,Yes,Yes,7.0,Not Reported,N,02/21/2021,02/23/2021,2.0,PVT,insulin pen 3 times daily with meals - 10 units before breakfast and 12 units before lunch and dinner metoprolol tartrate 100 mg po bid timolol maleate 0.5% ophthalmic solution 1 drop left eye every morning travoprost 0.004% ophthalmic sol,"Patient had been having progressive fatigue, malaise, and weakness for 2-3 months prior to admission to the hospital on 2/24/21.","Primary open angle glaucoma (POAG) of left and right eyes Type 2 diabetes mellitus without complication Diplopia Hyperlipidemia Giant cell arteritis Peripheral reticular degeneration of both eyes Essential hypertension Nonmelanoma skin cancer AK (actinic keratosis) s/p ce/iol/gonio left eye 09/18/2018 s/p ce/iol/gonio right eye 10/10/2018 Anemia Enlarged lymph nodes Pseudophakia of both eyes History of pulmonary embolus, on warfarin H/O adenomatous polyp of colon Recurrent epigastric hernia Umbilical hernia without obstruction and without gangrene Epigastric hernia",,latanoprost - eye discomfort,"['Acute myeloid leukaemia', 'Acute undifferentiated leukaemia', 'Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Asthenia', 'Atelectasis', 'Biopsy bone marrow abnormal', 'Blood albumin normal', 'Blood bilirubin normal', 'Blood creatine phosphokinase increased', 'Blood creatinine normal', 'Blood culture positive', 'Blood smear test', 'Body temperature increased', 'C-reactive protein increased', 'Cellulitis', 'Chest X-ray abnormal', 'Computerised tomogram abdomen normal', 'Computerised tomogram head normal', 'Computerised tomogram pelvis', 'Cytogenetic analysis', 'Escherichia test positive', 'Groin pain', 'HLA marker study positive', 'Haemoglobin decreased', 'Mental status changes', 'Muscular weakness', 'Myalgia', 'Neutropenia', 'Normocytic anaemia', 'Oedema', 'Parasite blood test', 'Platelet count decreased', 'Pleural effusion', 'Protein total decreased', 'Red blood cell sedimentation rate increased', 'SARS-CoV-2 test negative', 'Scan with contrast abnormal', 'Staphylococcus test negative', 'Swelling', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 1063903,TX,69.0,M,NO SPECIFIC ADVERSE EVENT DUE TO THE VACCINE BUT THE PATIENT PASSED AWAY 02/10/2021 DUE TO COVID,Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,N,01/09/2021,02/10/2021,32.0,PHM,"METOPROLOL TARTRATE 25MG, AMIODARONE 200MG, FUROSEMIDE 80MG, PARICALCITOL 1MCG, AMLODIPINE 5MG",,"CONGESTIVE HEART FAILURE, KIDNEY FAILURE,",,NKA,"['COVID-19', 'Death']",1,MODERNA,IM 1063929,,65.0,M,"Patient hospitalized for fever thought to be related to 2nd dose of covid vaccine. See hospital a/p from H&P. Assessment/Plan: Fever, myalgias and headache, I think this is all secondary to his recent Covid vaccine yesterday, dose 2. I would anticipate his symptoms should resolve over the next 24 to 48 hours. He was started on vancomycin in the emergency room given history of MRSA. We will continue for now, though I think less likely secondary infection. He is on Cipro for SBP prophylaxis. He does not seem to have significant ascites. I think bacterial peritonitis is less likely. � End-stage renal disease on hemodialysis. I spoke with individual. Plan is to dialyze him here today. � Cirrhosis -he was evaluated by the transplant center at Hospital on February 25. His meld was 25 at that time. � History of type 2 diabetes. His last hemoglobin A1c's have been all 5. Can remove that from his problem list.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/26/2021,02/27/2021,1.0,PVT,,,,,,"['Dialysis', 'End stage renal disease', 'Glycosylated haemoglobin normal', 'Haemodialysis', 'Headache', 'Model for end stage liver disease score', 'Myalgia', 'Peritonitis bacterial', 'Prophylaxis', 'Pyrexia']",UNK,MODERNA, 1063950,OH,62.0,M,Patient remained at baseline until noted at 2130 unresponsive and abnormal VS. Sent to ED and patient passed away in ED,Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,,02/26/2021,02/26/2021,0.0,SEN,,,,,,"['Death', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 1063980,CA,91.0,F,1/26 /2021 - pt went to ER for chest pain 2/9/2021 - pt received Pfizer COVID vaccine 1st dose 2/17/2021 - cardiac arrest with death,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/17/2021,8.0,PVT,"Atenolol 50mg qday, clonidine 0.2mg bid, glipizide xl 10mg qday, hctz 25mg qday, ISDN 30mg bid, Januvia 100mg qday, Cozaar 100mg qday, metformin 500mg qday, nifedipine CC 60mg bid, actos 15mg qday,","Mildly enlarged cardiomediastinal silhouette. went to the ER on 1/26, 15 days prior to vaccine. c/o episodes of 4/10 midsternal nonradiating chest pain, first at noon after eating and second episode woke her from sleep at 0400","HTN, DM type 2, CKD IV",,NKA,"['Cardiac arrest', 'Chest pain', 'Death']",1,PFIZER\BIONTECH,IM 1063981,CA,65.0,M,Day one was low-grade fever and fatigue. Day two was vomiting. Day three through five was vomiting and continuous diarrhea. Hospital admission on day five for dehydration. Diarrhea continued through day eight post vaccination.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/14/2021,02/16/2021,2.0,OTH,Metformin Glimeperide Jardiance Trulicity Pravachol Ramapril Fish oil Aspirin Vitamin B12 Multi vitamin,None,Type 2 diabetes,,NKA,"['Blood test normal', 'Culture stool negative', 'Dehydration', 'Diarrhoea', 'Fatigue', 'Pyrexia', 'Urine analysis normal', 'Vomiting']",2,PFIZER\BIONTECH,SC 1063984,WI,80.0,F,"Patient had her second COVID vaccine on 2/20/21. The next day she developed diffuse body aches. She went on to develop worsening dyspnea and fever to 103�F on February 23. She had a fever again on February 24. The patient also experienced a few episodes of vomiting and diarrhea but no abdominal pain and had pain of the legs, right greater than left. Blotchy red patches of the hands and arms developed. She therefore presented to the ER on 2/25/21. See full history below from infectious disease note on 3/1/21: Patient is an 80 year old female who has a past medical history notable for hypertension, dyslipidemia, and hypothyroidism. The patient was diagnosed with a high-grade lymphoma of the retroperitoneum in 2004 and completed 4 cycles of multi-chemotherapy (Cytoxan, Adriamycin, vincristine, methotrexate, and IT chemotherapy (Magrath-like regimen)). She completed 4 cycles with complete remission on PET scan. The biopsy of a left cervical lymph node in 2007 revealed follicular lymphoma and she completed radiation therapy to the neck with complete remission. A left axillary lymph node biopsy in 2016 revealed grade-3 follicular lymphoma with mixed follicular and diffuse histology. Chemotherapy was pursued. The biopsy of a pelvic lymph node in 2019 was consistent with G1-2 follicular lymphoma. �She completed radiation to the pelvis in May of 2019. �She developed progressive pelvic adenopathy in April of 2020 and received 5 cycles of chemotherapy. Subsequent CT showed improvement in the adenopathy. �Her course was complicated by pulmonary emboli (September 2020). �In November of 2020 she was started on maintenance Rituxan every 2 months. �She received the 2-dose Pfizer COVID vaccine series on 1/29/21 and 2/20/21. With the above background, the patient presented to the emergency room on February 25, 2021 with complaints of diffuse body aches, which had developed that day after receiving her second dose of COVID-19 (SARS-CoV-2) vaccine. �She went on to develop worsening dyspnea and fever to 103�F on February 23. �She had a fever again on February 24. The patient also experienced a few episodes of vomiting and diarrhea but no abdominal pain and had pain of the legs, right greater than left. Blotchy red patches of the hands and arms developed. �She called Oncology on February 20 and it was recommended that she go to the emergency room for evaluation. � She was afebrile on presentation to the emergency room. �She was tachycardic, however, with a pulse rate of 117 bpm. �She was breathing at 48 breaths per minute. �Blood pressure was 105/80 mmHg. �Oxygen saturation by pulse oximetry was 96%. Examination was notable for paraspinous muscle tenderness, tachypnea, mild respiratory distress, and a mildly distended abdomen. �Mild erythematous patches of the feet and forearm were noted, as well as evidence of edema of the right leg from the knee to the lower leg. The peripheral blood leukocyte count measured 0.8x10e3/�L. �ANC was 0.48x10e3/�L. �Platelets measured 96x10e3/�L. �Creatinine was 0.97 mg/dL. �AST was 86 and ALT 20 U/L. The lactic acid level of the venous blood was 3.6 mmol/L. The procalcitonin level of the blood measured 28.37 ng/mL. The C-reactive protein level was 313.7 mg/deciliter. The creatine kinase (CK) level was 4023 U/L. �LDH measured 314 U/L. Troponin was 3.22 ng/mL. �Urinalysis showed 6-10 wbc?s, 0-2 rbc?s/hpf, 3+ blood, negative nitrites, hyaline and granular casts as well as amorphus crystals. A chest radiograph showed possible, but not definite, mild atelectasis or infiltrate at the left lung base. �A radiograph of the right tibia/fibula showed circumferential soft tissue edema seen within the knee and upper to mid aspect of the lower leg. �EKG showed sinus tachycardia but no evidence of arrhythmia or ischemia. Cultures of specimens of the blood were obtained. �The patient was started empirically on vancomycin and cefepime and was admitted. � Faint erythema and ecchymosis of the right leg extending to the dorsal right foot and right wrist erythema were noted following the patient?s admission. �Her condition subsequently destabilized with increased respiratory rate, worsening pain, and hypotension, so she was transferred to the ICU. An abdominopelvic CT on February 25 revealed a small amount of free fluid in the abdomen around the liver, cholelithiasis with no evidence of acute cholecystitis or biliary dilatation, a nonobstructing 5-mm stone of the mid pole of the left kidney, coronary artery calcifications, mild infiltration of the fat in the inferior retroperitoneum and along the right common iliac region with small nodes in this region, similar compared with September 24, 2020, but improved compared with April 30, 2020, and consistent with response of lymphoma to chemotherapy; a myomatous uterus. A CT scan of the right lower extremity showed extensive edema about the subcutaneous tissues of the right lower leg and infiltration of the fat about the muscles of the right lower leg, likely representing cellulitis and fasciitis, and possible myositis. However, there was no air within the subcutaneous tissues or muscles to suggest necrotizing fasciitis and no evidence of abscess. � � The patient?s antibiotic treatment was later changed to vancomycin, piperacillin-tazobactam and clindamycin. Cultures of specimens of the blood were later reported as being positive for methicillin-susceptible Staphylococcus aureus on 2/2 sets. Repeat blood cultures (February 26) were positive as well. Her antibiotics were modified to cefazolin monotherapy. Repeat blood cultures on Feb 27 and 28 were negative. � TTE completed 2/27/21 without obvious vegetation. � TODAY (3/1/21): Cultures negative 2/27 and 2/28. Remains on IVIG. Afebrile. She complaints of continued pain in the Right leg and swelling at that left arm. Exam GENERAL: NAD EYES: Sclera and conjunctiva clear NECK: no adenopathy LUNGS: Breath sounds normal and symmetric. No rales or wheezes. HEART: regular rhythm, no murmur appreciated ABDOMEN: Soft without mass, tenderness, organomegaly or hernia. EXTREMITIES: RLE with ecchymosis, slight overlying erythema and anterior blister: blistering more pronounced today. left foot with plantar erythema, some tenderness today. LUE fullness with some heat/tenderness SKIN: No other rashes or other abnormalities are noted. NEUROLOGICAL: alert, appropriate Assessment 1. MSSA septicemia with shock. Positive blood cultures 2/25 and 2/26 thus far. Negative since 2/27. 2. Multifocal cellulitis and interstitial infective myositis of LE- suspect related to above. CT scan was negative for apparent necrotizing infection. 3. Elevated CK due to above- improving 4. Recurrent lymphoma- has been on maintenance rituximab (11/2020). Immunocompromised state. 5. Low immunoglobulins- remains on IVIG 6. Positive urine cultures with Staph aureus- this is typically secondary seeding from bacteremia rather than primary staph uti. CT abd/pelvis negative for nidus of infection along GU track (no renal abscess for example) 7. LUE swelling/tenderness. � Plan 1. Cont Cefazolin without change: goal dosing 8gm/24hr 2. Following repeat blood cultures, negative thus far (tentative D0= 2/27/21) 3. Pending course, anticipate likely TEE--- > presently precluded due to thrombocytopenia 4. Will obtained LUE doppler for completeness given pain/swelling here. Down the line, may need to consider additional imaging (CT?) if concern for abscess, etc). 5. ID will follow along with you. Please call if any questions/concerns. Patient is still admitted, and is in the ICU.",Not Reported,,Yes,Yes,6.0,Not Reported,N,02/20/2021,02/21/2021,1.0,PVT,? acetaminophen (TYLENOL) 500 MG tablet Take 500 mg by mouth every 4 hours as needed for Fever or Pain Maximum allowable Acetaminophen amount = 4 Grams (4000 mg) / 24 hours. � � ? acyclovir (ZOVIRAX) 400 MG tablet TAKE 1 TAB TWICE DAILY 60,none,"PAST MEDICAL HISTORY: Hypertension, dyslipidemia, hypothyroidism, follicular lymphoma, past DVT, past PE, history of colonic polyps, nephrolithiasis, osteopenia. � PAST SURGICAL HISTORY: Tonsillectomy, left carpal tunnel release, hysteroscopy �2, thyroidectomy, D&C, colonic polyp removal, bone marrow biopsy �2, cervical lymph node excision, tailbone excision, laser therapy of left retinal tear.",,hydrocodone - severe restless legs,"['Abdominal distension', 'Alanine aminotransferase normal', 'Arrhythmia', 'Arteriosclerosis coronary artery', 'Ascites', 'Aspartate aminotransferase increased', 'Atrial fibrillation', 'Bacteraemia', 'Blister', 'Blood creatine phosphokinase increased', 'Blood creatinine normal', 'Blood culture', 'Blood lactate dehydrogenase increased', 'Blood lactic acid decreased', 'Blood pH increased', 'Breath sounds normal', 'C-reactive protein increased', 'Cellulitis', 'Chest X-ray abnormal', 'Cholelithiasis', 'Computerised tomogram', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram abdomen normal', 'Computerised tomogram pelvis', 'Computerised tomogram thorax normal', 'Condition aggravated', 'Crystal urine', 'Culture', 'Culture urine positive', 'Diarrhoea', 'Dyslipidaemia', 'Dyspnoea', 'Ecchymosis', 'Echocardiogram', 'Electrocardiogram abnormal', 'Erythema', 'Erythema', 'Fat tissue increased', 'Hypertension', 'Hypotension', 'Hypothyroidism', 'Immunoglobulin therapy', 'Immunoglobulins decreased', 'Inappropriate schedule of product administration', 'Intensive care', 'Lymphoma', 'Myalgia', 'Myositis', 'Nephrolithiasis', 'Neutrophil count', 'Nitrite urine absent', 'Oedema peripheral', 'Oedema peripheral', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Plantar erythema', 'Platelet count', 'Platelet count decreased', 'Procalcitonin increased', 'Pyrexia', 'Rash', 'Rash erythematous', 'Rash erythematous', 'Rash macular', 'Rash macular', 'Respiratory distress', 'Respiratory rate increased', 'Scan with contrast', 'Skin warm', 'Staphylococcal sepsis', 'Tachycardia', 'Tachypnoea', 'Tenderness', 'Thrombocytopenia', 'Troponin increased', 'Urinary casts', 'Urinary nitrogen increased', 'Urine analysis abnormal', 'Vomiting', 'White blood cell count', 'X-ray limb abnormal']",2,PFIZER\BIONTECH,IM 1064028,,40.0,F,Anaphylactic reaction - patient intubated for airway protection.,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/27/2021,02/27/2021,0.0,PUB,Methadone 10 mg Q4H Insulin glargine 34 units once daily Liraglutide 1.8 mg once daily,,Diabetes mellitus,,Sulfamethoxazole/trimethoprim Metronidazole Morphine Lamotrigine Topiramate Fluoxetine Oxycodone/acetminophen Ketorolac Azithromycin Vancomycin IV Dye Nuts Seafood,"['Anaphylactic reaction', 'Endotracheal intubation']",1,MODERNA, 1064045,TX,57.0,F,"Pt reported SOB, asthma like exacerbation, wheezing, feeling like throat was closing about 1 hour after vaccine. Reported taking home inhalers. Denied going to the emergency room or LOC Pt now feels good, at baseline",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,PVT,"singulair, clonazepam, Advair diskus, albuterol, trintellix",Asthma exacerbation,"Asthma, depression",,Morphine Meperidine,"['Asthma', 'Dyspnoea', 'Throat tightness', 'Wheezing']",1,PFIZER\BIONTECH,IM 1064057,NC,37.0,F,"Fever (max 105F), generalized tonic clonic seizure lasting >60minutes resulting in rhabdomyolysis , leukocytosis (16k) s/p ceftriaxone x 1 with COVID-19, Flu A/B, RSV all PCR negative followed by transfer to hospital (2/25/2021) with ongoing high fever (Tmax 104F), Admission labs found rhabdomyolysis (CK >100,000 on day 2), elevated lactate (4.4), acute liver injury (AST/ALT >5000), elevated Cr (3.8) requiring CVVHD, DIC, shock, and respiratory failure requiring urgent intubation.",Not Reported,,Yes,Yes,5.0,Not Reported,N,02/24/2021,02/24/2021,0.0,OTH,"Keppra 2500 mg orally twice a day, oxcarbazepine 900 mg bid and Xcopri 50 mg in AM and 200 mg in PM. Altace 10 mg daily, Zoloft 50 mg, Everolimus 10 mg",None known acute,"Tuberous sclerosis complex Renal Angiomyolipoma Hepatic cyst Hypertension Mild Intellectual Disability Autism Mild depression and anxiety Epilepsy with complex partial seizures, remote history of generalized tonic clonic seizures last at 16years of age",partial seizure after first dose (baseline frequency 2-3/month),Depakote Phenobarbital,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood creatine phosphokinase increased', 'Blood creatinine increased', 'Blood gases abnormal', 'Blood lactic acid increased', 'Blood lactic acid normal', 'Disseminated intravascular coagulation', 'Endotracheal intubation', 'Generalised tonic-clonic seizure', 'Generalised tonic-clonic seizure', 'Haemoglobin decreased', 'Influenza A virus test negative', 'Influenza B virus test', 'International normalised ratio increased', 'Leukocytosis', 'Liver injury', 'Platelet count decreased', 'Pyrexia', 'Respiratory failure', 'Respiratory syncytial virus test negative', 'Rhabdomyolysis', 'SARS-CoV-2 test negative', 'Serum ferritin increased', 'Shock', 'Troponin increased', 'White blood cell count increased']",2,MODERNA,IM 1064071,CA,69.0,M,Whole body weakness starting the next morning,Not Reported,,Not Reported,Yes,,Not Reported,N,02/26/2021,02/27/2021,1.0,PVT,Tamsulosin,None,Has spinocerebellar ataxia type I,,No,"['Asthenia', 'Laboratory test', 'Magnetic resonance imaging brain', 'Magnetic resonance imaging neck', 'Magnetic resonance imaging spinal', 'Myasthenia gravis']",2,MODERNA,SYR 1064080,NY,79.0,F,"Patient was diagnosed with acute leukemia within 6 weeks of receiving first and 2 week of receiving second Covid Vaccine. I do NOT think vaccine caused the leukemia, but am reporting it in view of timing of her having received the vaccine and being diagnosed.",Not Reported,,Yes,Yes,7.0,Not Reported,N,01/14/2021,02/16/2021,33.0,PHM,Levothyroxine Dyazide Crestor,,HTN Hyperlipidemia Hypothyroidism,,,"['Acute leukaemia', 'Biopsy bone marrow', 'Biopsy bone marrow abnormal', 'Full blood count', 'Haemoglobin decreased', 'Myeloid leukaemia', 'Platelet count decreased', 'White blood cell count decreased']",1,MODERNA,IM 1064121,OH,25.0,F,"Within one month after vaccination, developed joint pain, joint stiffness, joint swelling in bilateral finger joints. Had labs, xrays and assessment completed. New finding and diagnosis of rheumatoid arthritis",Not Reported,,Not Reported,Not Reported,,Yes,N,12/29/2020,01/01/2021,3.0,PVT,Adderall XR 40mg daily Spironolactone 100 mg daily,None,"ADHD, acne",,"Sulfa, tetracyclines","['Anti-cyclic citrullinated peptide antibody', 'Antinuclear antibody', 'Arthralgia', 'C-reactive protein', 'C-reactive protein abnormal', 'Joint stiffness', 'Joint swelling', 'Laboratory test', 'Peripheral swelling', 'Red blood cell sedimentation rate abnormal', 'Rheumatoid arthritis', 'Rheumatoid factor', 'X-ray']",UNK,MODERNA, 1064123,KY,40.0,F,Fetal demise sometime between 15-18 weeks based on ultrasound findings. EDC 7/30/2021,Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/16/2021,02/28/2021,12.0,WRK,Lantus Valtrex Phenergan Cyclobenzaprine Prenatal Vitamin Unisom,,,,,"['Exposure during pregnancy', 'Foetal death', 'Ultrasound antenatal screen abnormal']",2,PFIZER\BIONTECH,IM 1064195,CO,71.0,M,I had an MI the next AM.,Not Reported,,Yes,Yes,4.0,Not Reported,Y,02/13/2021,02/14/2021,1.0,PVT,"Ambien, Lorsartan, hydrochlorothyazide.",None,Hypertension,,None,['Myocardial infarction'],UNK,MODERNA, 1064202,GA,85.0,M,"Sent to ER then admitted to Medical, then sent to rehab, then back to ER, then back to rehab.",Not Reported,,Not Reported,Yes,10.0,Not Reported,N,01/21/2021,01/28/2021,7.0,OTH,"Carvedilol, Gabapentin, Eliquis, Bumetanide, Hydrocodone",,"Chronic pain in neck area, right shoulder, cervical area in back.",,None that I know of.l,"['Blood test', 'Computerised tomogram', 'Magnetic resonance imaging', 'Unevaluable event']",2,PFIZER\BIONTECH,SYR 1064210,CA,33.0,F,"The next day I had full body aches, fatigue and exhaustion and low grade fever and no appetite. I developed a severe rash where I got the injection. The fever and body aches just lasted to Friday. Saturday, I still had the rash area on my arm and it got bigger. Saturday - Telehealth visit. Rash on arm took five days to go away. Told me to put a hot compress on it if I wanted to but no other advice given. Pregnancy - February 12 - Preeclampsia was diagnosed. I was induced that day so baby was a week early -. February 20 had been estimated due date. This was my first pregnancy. I got COVID when I was pregnant in October. I was hospitalized with the heart rate issue that they thought occurred because of COVID November 16-19th. I have a healthy baby girl!",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/28/2021,01/29/2021,1.0,OTH,prenatal vitamins; iron supplement,no,pregnancy; November I was diagnosed - advanced fast heart rate,,pineapple; artichokes - mouth and lips get itchy and lips get swollen,"['Decreased appetite', 'Exposure during pregnancy', 'Fatigue', 'Induced labour', 'Injection site rash', 'Pain', 'Pre-eclampsia', 'Pyrexia']",2,MODERNA,SYR 1064214,OR,83.0,M,Pulmonary Embolism suffered on 2/13/2021. Hospitalized at Medical Center. Discharged on 2/20/2021. Still recovering.,Not Reported,,Yes,Yes,7.0,Yes,N,02/10/2021,02/13/2021,3.0,PVT,"Insulin - Novolin 70/30, Bisopriol, Lisinopril, Atorvastatin, Symbicort. Allopurinol, Albuterol, Triamterene","Diabetes, COPD, hypertension","Diabetes, COPD, hypertension",,Quinine (causes hives) Penicillin (causes oral yeast infection),"['Computerised tomogram', 'Pulmonary embolism', 'Ultrasound scan', 'X-ray']",2,PFIZER\BIONTECH,IM 1064222,AK,24.0,F,"The patient presents today with a history of recurrent urticaria and angioedema. She received a dose of the Pfizer COVID-19 vaccine on Thursday Feb 25th (lot number EN 6206). She felt fine after her shot, but the next day felt fatigued, had chills, body aches, and left arm soreness (at the site of the injection)--she attributed her symptoms to her vaccination. Friday evening, prior to bed, she noticed the onset of several scattered hives. The next day, she noted that she had more extensive hives over her body, including her eyelids, and she said that she has been having dyspnea; she presented to the ER and was treated with steroids and antihistamines. The symptoms or urticaria returned the next day with significant angioedema of the lips, and the patient had dyspnea and nausea/abdominal discomfort, and the patient went back to the ER. With antihistamines and steroids, her symptoms improved significantly and she was sent home. Her symptoms returned today, now accompanied by throat globus as well as abdominal discomfort--she self administered an Epipen, which she said significantly helped her symptoms.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/25/2021,02/26/2021,1.0,MIL,"levothyroxine, Miralax, multivitamin, fish oil","The patient felt ill one week after her first Pfizer vaccine (given on 2/5/20)--she reported diaphoresis, temperature instability. A COVID test was negative.",hypothyroidism; possible autoimmune disorder; history of chronic urticaria (resolved at age 17); scoliosis; generalized anxiety disorder; PTSD; hiatal hernia; gastritis,,penicillin,"['Abdominal discomfort', 'Angioedema', 'Chills', 'Condition aggravated', 'Dyspnoea', 'Fatigue', 'Injection site pain', 'Nausea', 'Pain', 'Sensation of foreign body', 'Urticaria']",2,PFIZER\BIONTECH,IM 1064256,NM,18.0,F,"Pt presented by EMS for acute epigastric pain radiating to the back. While waiting for lab results, she was found down in her room and in post-ictal state. She was moved from an urgent care room to an ER bed and returned to near baseline when she had witnessed seizure activity and subsequently required multiple medications to break her status that lasted around 30 minutes",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/18/2021,02/19/2021,1.0,PVT,"hydroxychloroquine, ASA 81 mg, mycophenolate, zonisamide, lacosamide, lisinopril, calcium carbonate-vitamin D",,"systemic lupus erythematosus, lupus cerebritis, seizure disorder, lupus nephritis",,levetiracetam - thought to have caused renal impairment,"['Abdominal pain upper', 'Acute myocardial infarction', 'Back pain', 'C-reactive protein normal', 'Computerised tomogram abdomen normal', 'Computerised tomogram head normal', 'Condition aggravated', 'Full blood count normal', 'Hypotension', 'Leukocytosis', 'Lipase normal', 'Metabolic function test normal', 'Neutrophil percentage increased', 'Pain', 'Postictal state', 'Red blood cell sedimentation rate normal', 'Seizure', 'Troponin increased', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1064265,AR,77.0,M,Death,Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,PHM,"Fluoxetin 20mg - 1 every day, Lisinopril/HCTZ 20 - 12.5 mg - 1 every day, Potassium CL ER 20MEQ Micro - 1 twice daily, Pravastatin 40mg - 1 every day, Tamsulosin .4mg - 1 every day Vitamin D 50 mcg - 1 every day, Vitamin E 180 mg - 1 every",,,,,['Death'],2,MODERNA,SYR 1064294,CA,92.0,F,Death on 2-28-21. Not felt by this provider to be likely related to vaccination.,Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,02/26/2021,02/28/2021,2.0,PVT,"Losartan 50 mg bid, Calcium Carbonate 500 nmg qd, Aspirin 81 mg qd, multivitamins, Macuhealth",none,"Hypertension, Hyperlipidemia, Diverticulosis, Osteopenia, Kyphosis",,nkda,['Death'],2,MODERNA,IM 1064315,CT,42.0,M,"2/21/21 had slight chest pressure radiating to shoulder blades. Rested for half hour. Didn?t go away. Went to Hospital. Normal ekg. Normal bp. E.R. Determined elevated Troponin level of .10, admitted inpatient for observation, Troponin level went up to 6.3 within hours and 10.9 a day later. Was given heparin iv drip. Cardiac cath w dye done. No blockages found. Several more normal ekg?s done. Normal echocardiogram. Level of heart damage unknown because cardiac mri was not available for use (fully booked). Discharged home.",Not Reported,,Yes,Yes,3.0,Not Reported,U,02/10/2021,02/21/2021,11.0,PVT,Omeprazole Losartan Atorvastatin Glyburide Metformin Asprin Vitamin c Vitamin d Zinc Testosterone,None,Morbid obesity Diabetes type 2,,Shellfish,"['Arthralgia', 'Blood pressure increased', 'Catheterisation cardiac normal', 'Chest discomfort', 'Echocardiogram normal', 'Electrocardiogram normal', 'Pain', 'Troponin increased']",2,MODERNA,IM 1064355,FM,58.0,F,"Blurring of vision of the right eye few hours after receiving the vaccine described as brown threads or webs floating, initially coming form the temporal side gradually moving and spreading to the nasal half then total blocking her vision.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/17/2021,02/17/2021,0.0,PUB,None,None,None,,None,"['Vision blurred', 'Visual acuity tests abnormal', 'Visual impairment', 'Vitreous floaters']",1,MODERNA,IM 1064361,MI,86.0,F,Four blood clots in left leg,Not Reported,,Yes,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,PVT,Alprazolam 0.25mg prn Fluticadone propion-salmeterol 250-50mcg provides Glimepiride 2mg bid Gabapentin 300mg has Singulair 10mg has Prilosec 20mg bid Zocor 20mg hs Trospium 20mg bid,None,Hx of pneumonia x 4,,Bactrim Codeine Morphine,"['Fibrin D dimer increased', 'Thrombosis', 'Ultrasound Doppler abnormal']",1,MODERNA,IM 1064374,LA,85.0,M,clammy and then night sweats.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/24/2021,02/26/2021,2.0,PHM,unknown,unknown,unknown,,none,"['Cold sweat', 'Night sweats', 'Urinary tract infection']",2,MODERNA,IM 1064413,OH,82.0,F,My mom received the Pfizer Covid 19 vaccine on 1/4/21. On 1/12/21 I received a call from the nursing home that my mom had stopped eating and drinking and that she had nothing to eat or drink for 3 days. I asked them why they didn't call me sooner but they did not have an answer. I was told to come in because she was very lethargic and possible dehydrated. They tested her for Covid the morning of 1/12/21 and she tested negative. I went into see my mom and she was barely conscious. They gave her fluids intravenously but it had no positive affect on her condition. On 1/14/21 she tested positive for covid and was moved to their covid unit. I called in Hospice comfort care on 1/15/21. My. mom died on 1/17/21.,Yes,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/09/2021,5.0,SEN,No,No,Type 2 Diabetes,,No,"['COVID-19', 'Death', 'Dehydration', 'Depressed level of consciousness', 'Diet refusal', 'Lethargy', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1064422,IL,89.0,F,"Loose the control on the body, Head spinning because of this can't seat or stand without help not able to walk or get up from the bed.",Not Reported,,Not Reported,Yes,4.0,Yes,N,01/29/2021,02/04/2021,6.0,PVT,"Combitide CFC Inhaler, Lorazepam Tablets 1 MG.",Asthma,Asthma,,not any,"['Dyskinesia', 'Dysstasia', 'Gait inability', 'Mobility decreased', 'Vertigo']",1,PFIZER\BIONTECH,SYR 1064433,AL,72.0,M,Cardiac Arrest,Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,N,02/27/2021,03/01/2021,2.0,UNK,Unknown,,,,Unknown,['Cardiac arrest'],2,MODERNA,SYR 1064447,CO,70.0,F,"5 hours after administration developed severe left sided hip pain, skin sensitivity, leg paresthesia's and weakness. Progressive pain up to back and down to knee after that, weakness led to several falls. Malaise, diarrhea.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/19/2021,02/19/2021,0.0,PUB,"Black cohosh, MSM, glucosamine, Vitamin b12, coq10, fish oil, vitamin d",none,Former smoker,,Etodolac,"['Arthralgia', 'Back pain', 'Diarrhoea', 'Fall', 'Hyperaesthesia', 'Magnetic resonance imaging', 'Malaise', 'Muscular weakness', 'Paraesthesia', 'X-ray']",UNK,MODERNA, 1064633,CO,20.0,F,"1st dose: Pain and soreness at the injection site lasting 5 days post-injection. Moderate headache 6 hours post-injection acetaminophen was taken 8 hours post-injection. 2nd dose: Pain and soreness at injection site. Moderate headache, fatigue. 6 hours post-injection 18 hours post-injection very severe headache/migraine lasting 12 hours fatigue lasting 24-72 hours post-injection mild to moderate muscle pain 24-72 hours post-injection mild to moderate joint pain/aches 48-72 hours post-injection mild nausea 24-72 hours post-injection very mild acetaminophen was taken 24 hours post-injection rash at injection site developed 72 hours post-injection at the injection site measuring 3 inches in length and 2 inches in width with jagged edges. Is red and hot to the touch and the injection site is sore and firm very mild itch.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/27/2021,02/28/2021,1.0,PHM,Welbutrin xl Tri-Sprintec,none,none,,penecillin,"['Arthralgia', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site warmth', 'Migraine', 'Myalgia', 'Nausea']",2,MODERNA,SYR 1064646,HI,98.0,F,"Minor arm pain on 2nd day of each vaccine Diarrhea 3 days after 2nd vaccine Massive heart attack (left ventricle) 8 days (2/24/21) after vaccine Home hospice 3:30pm 2/24/21 Stopped breathing 5:45 am, pronounced dead at 8:22 am on 2/25/21",Yes,02/25/2021,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/24/2021,8.0,PUB,Aspirin Simvastatin Omeprazole Amlodipine,,High blood pressure Stroke 2017 and 2019,,Shrimp Hydrochlorothiazide,"['Computerised tomogram', 'Death', 'Diarrhoea', 'Myocardial infarction', 'Pain in extremity', 'Respiratory arrest']",2,PFIZER\BIONTECH, 1064661,MA,80.0,F,My mother had a seizure on February 15th after recieving the moderna vaccine on February 11th within four days of the vaccine. Doctors at hospital. Staff cannot answer what caused the seizure though they found a 4mm bleed on her brain; believed unrelated to seizure; on an MRI. My mother has never had a seizure and noone in my family have had seizures. I don't know if it's related to the vaccine but felt it should be reported to you.,Not Reported,,Not Reported,Yes,8.0,Yes,U,02/11/2021,02/15/2021,4.0,PVT,"Folic acid, valsartan, amplodapine, sertreline, tylenol,",Primary Progressive Aphasia,Dementia,,none,"['Cerebral haemorrhage', 'Computerised tomogram', 'Echocardiogram', 'Magnetic resonance imaging head abnormal', 'Seizure']",UNK,MODERNA,SYR 1065073,IL,,F,"Lymph glands were swollen; Headache; A spontaneous report was received from a healthcare professional regarding his coworker, female nurse ,who received Moderna Covid-19 vaccine and have experienced headache and swollen lymph glands. The patient's medical history was not provided. Her concomitants were not provided. No information on allergies. On 10-FEB-2021, prior to the onset of events, the patient received her first of two planned doses of Covid-19 vaccine for the prophylaxis of Covid-19 infection. On the same day, she felt headache and her lymph glands were swollen. She stayed overnight at the hospital for treatment. Action taken with 2nd dose of Moderna Covid-19 vaccine was not reported. The outcome of the events were unknown at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/10/2021,02/10/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Headache', 'Lymphadenopathy']",1,MODERNA,OT 1065074,,,F,"Bell's Palsy; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's palsy. The patient's medical history was not provided. Concomitant product use was not provided. On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, post vaccination, the reporter who is the patient's son, stated the patient was diagnosed with Bell's palsy. Treatment for the event included, hydroxypropyl methylcellulose, prednisone and valacyclovir. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, Bell's palsy, was considered unknown.; Reporter's Comments: Very limited information regarding the event of Bell's Palsy has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Facial paralysis'],1,MODERNA,OT 1065075,,,F,"Hospitalized; Unable to receive second dose of vaccine; Case reference number MOD-2021-014001 is a spontaneous case report sent by a Non-Health Professional on 15-FEB-2021 00:00:00 . On the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. After vaccination she was hospitalized and she was unable to receive the second dose of the vaccine. Action taken with mRNA-1273 was not provided. Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Non-Health Professional, Age- , Sex- Female, Suspect Drug- Moderna COVID-19 Vaccine, Treatment- Diagnosis\Outcome- hospitalized - unknown; unable to receive the second dose of the vaccine - resolved.; Reporter's Comments: This case concerns a female of unknown age who experienced a serious unexpected event of Hospitalisation and nonserious unexpected event of Inappropriate schedule of product administration, in that she ""unable to receive the second dose of the vaccine"". The events occurred with unknown latency after the first dose of mRNA-1273. Very limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Hospitalisation', 'Inappropriate schedule of product administration']",1,MODERNA,OT 1065076,FL,71.0,M,"Emergency pacemaker; Pain in left shoulder; missed second dose; A spontaneous report was received from a consumer regarding her husband, a 71 year old male, who received first dose of Moderna Covid-19 vaccine and experienced missed the second dose due to hospitalization, emergency pacemaker insertion and pain in shoulder . The patient's medical history includes high blood pressure, hereditary heart disease, Fuchs Dystrophy and heart attack last year. His concomitant medications were amlodipine 5 mg tablets daily, potassium chloride and indapamide. No information on allergies. On 15-JAN-2021, prior to the onset of events, the patient received his first of two planned doses of Covid-19 vaccine intramuscularly on his left arm for the prophylaxis of Covid-19 infection(Lot#012LZ0A or 017LZ0A) She is not sure about the Lot number as she couldn't read the handwriting. On 11-FEB-2021, Patient had Emergency pacemaker insertion done at the hospital, where he stayed for two more days and discharged on 14-FEB-2021. As per his wife, this event is related to his previous heart problems which are ongoing for a long time. His 2nd dose of vaccine is scheduled on 12-FEB-2021, which he missed due to his hospitalization. Doctor said ""forget about the shot"" after seeing his results in monitor. She thinks, his doctor wouldn't talk about the 2nd dose of vaccine now, so wants to wait till his follow up appointment in March and he may get his second dose in 5-6-week limit. After being discharged from the hospital, wife reports husband is ""starting to feel better."" Sleeps a few hours and gets up and goes lays back down. Still experiencing pain in shoulder. Action taken with 2nd dose of Moderna Covid-19 vaccine was postponing of appointment until he is fine. The outcome of the event emergency pacemaker insertion was recovered and pain in shoulder is not recovered.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273. Based on the current available information and the mechanism of action of mRNA-1273 vaccine, the events of cardiac pacemaker insertion and arthralgia are assessed as unlikely related. The patient's medical history of high blood pressure, hereditary heart disease and heart attack are risk factors for cardiac pacemaker insertion and confounds causality.",Not Reported,,Yes,Yes,4.0,Not Reported,N,01/15/2021,02/12/2021,28.0,UNK,AMLODIPINE; POTASSIUM CHLORIDE; INDAPAMIDE,"Heart disease, unspecified; Hypertension",Medical History/Concurrent Conditions: Fuchs' endothelial dystrophy (with bilateral corneas replaced); Heart attack,,,"['Arthralgia', 'Cardiac pacemaker insertion', 'Inappropriate schedule of product administration']",1,MODERNA,OT 1065077,IN,,M,"Can't taste or smell food; Can't taste or smell food; No desire to eat; Headache; Severe bleeding; No power; He got tested and the blood became too thick; A spontaneous report was received from a consumer concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe bleeding, he got tested and the blood became too thick, headache, no power, no desire to eat, and can't taste or smell food. The patient's medical history was not provided. Concomitant product use was provided as anti-depressants and anti-anxiety medication but was unspecified. On 28JAN2021 prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:030L20A) intramuscularly for prophylaxis of COVID-19 infection. Patient received the 1st shot of the mRNA-1373 vaccine on 28Jan2021. Patient reported hearing that the vaccine could have messed with his coumadin levels. Patient got tested and reported that the blood became too thick and that after treatment to thin the blood, he had severe bleeding. Patient has a rhino rocket in his nose. About two weeks later after the vaccine, patient reported a headache, having no power, couldn't taste or smell food and had no desire to eat. Patient also reported following up with his Primary Care around about taking more anxiety medication due to this situation. The patient's doctor has provided his approval. Patient wanted to know if the side effects he is experiencing two weeks after the vaccine are normal. Treatment information was not provided. The outcome of the events was unknown.; Reporter's Comments: There is not enough detail in the absence of patient's medical history, onset date and list of concomitant medications to assess the events of blood became too thick and severe bleeding and can't taste or smell food. The events of headache, no power, no desire to eat are temporarily associated with the vaccine administration and a causal association cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/28/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Ageusia', 'Anosmia', 'Asthenia', 'Decreased appetite', 'Haemorrhage', 'Headache', 'Hypercoagulation']",1,MODERNA,OT 1065078,,,M,"Unresponsive; A spontaneous report was received from a Reporter concerning a 25 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No relevant concomitant medications were reported. On 22-DEC-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 01-JAN-2021, The patient became unresponsive and died which is serious. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On 01-JAN-2021, the outcome of the event unresponsive became fatal. patient died.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death",Yes,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,01/11/2021,20.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no medical history provided),,,['Sudden death'],1,MODERNA,OT 1065079,CA,71.0,F,"kindeys started to fail; blood pressure 60/24; red spots around the injection site; nausea; vomiting; diarrhea; cellulitis at the injection site; A spontaneous report was received from a nurse who was also a 61-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red spots around the injection site, nausea, vomiting, diarrhea, kidneys started to fail, and blood pressure 60/24. Medical history included type 2 diabetes mellitus, lung disease, and high blood pressure. Concomitant medication included unspecified cholesterol medicines, unspecified heart medicines, levopridsone, and unspecified type 2 diabetes mellitus medicines. On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot number 057G20A) intramuscularly n the left deltoid for prophylaxis of COVID-19 infection. On 29 Jan 2021, the patient experienced cellulitis at the injection site. On 02 Feb 2021, the patient experienced red spots around the injection site, nausea, vomiting, diarrhea, kidneys started to fail, and blood pressure 60/24 (no units or reference range provided). The patient was hospitalized from 04 Feb 2021 to 07 Feb 2021. Treatment for the events included hydration, unspecified antibiotics, and levid for blood pressure. Action taken with the mRNA-1273 was not reported. The outcome of the events of cellulitis at the injection site, red spots around the injection site, nausea, vomiting, diarrhea, kidneys started to fail, and blood pressure 60/24 was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,01/29/2021,01/29/2021,0.0,UNK,,Blood pressure high; Lung disease; Type 2 diabetes mellitus,,,,"['Blood pressure decreased', 'Blood pressure measurement', 'Diarrhoea', 'Nausea', 'Renal failure', 'Vaccination site cellulitis', 'Vaccination site rash', 'Vomiting']",1,MODERNA,OT 1065080,NJ,47.0,F,"Erythema multiforme; Swelling on the face; Full body rash; Joint pain; A spontaneous report was received from a HCP concerning a 47 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events - Swelling on the face, Joint pain, Full body rash, and Erythema multiforme (medically significant event). The patient's medical history was not provided. No relevant concomitant medications were reported. On 07-Feb-2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. Four days after receiving the vaccine the oatient started experiencing swelling on the face, joint pain, full body rash and erythema multiforme. Laboratory details were not provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events, swelling on the face, Joint pain, Full body rash, and Erythema multiforme were unknown.; Reporter's Comments: Based on the information provide which includes a strong temporal association and excluding other etiologies, a causal association between the reported events and the administration of the mRNA-1273 cannot be excluded. Joint pain, rash and facial swelling are consistent with the known safety profile of the product.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/07/2021,02/11/2021,4.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Arthralgia', 'Erythema multiforme', 'Rash', 'Swelling face']",2,MODERNA,OT 1065081,FL,88.0,F,"covid pneumonia; diarrhea, stomach issues; weakness; no appetite; Covid; A spontaneous report was received from a consumer concerning an 88-year-old, female patient who experienced diarrhea, got sick with COVID, stomach issues, weakness, no appetite, and covid pneumonia. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Eliquis, Omeprazole, and Metoprolol. On 07JAN2021, approximately 7days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. Caller stated that her mother in law who is 88 years old received the Moderna vaccine on 07Jan2021 and within 7 days, she got sick. Patient had had diarrhea, stomach issues, weakness, no appetite and ended up with covid pneumonia. Treatment for the events included Regeneron antibody therapy. Caller would like to know if the therapy negated the benefits of the vaccine. Action taken with mRNA-1273 in response to the event was not provided/unknown. The events, diarrhea, got sick with COVID, stomach issues, weakness, no appetite, and covid pneumonia were considered recovered/resolved.; Reporter's Comments: This case concerns an 88-year-old female who experienced a serious unexpected event of COVID-19 pneumonia along with unexpected COVID-19, decreased appetite, and asthenia. The events occurred 8 days after first dose of mRNA-1273. Treatment included Regeneron antibody. Further information has been requested. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/14/2021,7.0,UNK,APIXABAN; OMEPRAZOLE; METOPROLOL,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Asthenia', 'COVID-19', 'COVID-19 pneumonia', 'Decreased appetite', 'Diarrhoea']",1,MODERNA,OT 1065082,NM,56.0,M,"Anaphylactic reaction; A spontaneous report was received from a physician concerning a 56-year-old, male patient, who received their first of two planned doses of mRNA-1273, and who developed anaphylactic reaction. The patient's medical history included blindness and severe allergies to shellfish. Products known to have been used by the patient, within two weeks prior to the event, included Losartan and Melatonin. On 28 JAN 2021, approximately 15 minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient's wife called to indicate that her husband had an anaphylactic reaction to the mRNA-1273 vaccine. Patient received the vaccine on 28 JAN 2021 in his left arm. Patient's wife indicated that her husband texted her at 3.21 pm to let her know that he has gotten the shot, indicating that he must have received it around 3.19 pm. Patient's wife indicated that around 3.34 pm, patient said he'd had an anaphylactic reaction, that he had administered a shot of epinephrine and that an ambulance was on its way. The patient's wife noted that the reaction happened within 15 minutes or so. Once in the hospital, the patient was administered Pepcid and Steroid orally. Additional treatment medication for the event included the previously epinephrine and a shot of Benadryl. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. Patient's significant medical history included severe allergies to shellfish.",Not Reported,,Yes,Not Reported,,Not Reported,U,01/28/2021,01/28/2021,0.0,UNK,LOSARTAN; MELATONIN,Blind; Shellfish allergy (Severe Allergy to shellfish),,,,['Anaphylactic reaction'],1,MODERNA,OT 1065083,CO,55.0,F,"terrible time finishing sentences/such a hard time communicating; brain fog; Dizziness/remained dizzy for several hours/the room was spinning; shaking literally; congestion; Cough; my major joints (hip, knee, wrist, elbow, shoulder) were on fire; She felt she was going to die; vomited 2-3 hours; head felt on fire, when laying on her left side she could feel on the top of her head the pain move to the left side,type of pain in patient's head far more severe than any migraine patient's ever had; when lying down patient's head felt on fi; fatigued so badly; 103 fever for 2 days; swelling of the tongue; couldn't walk/could only crawl; when moving to the right side, she felt liquid in her brain pouring to that side,like an epilepsy attack in a smaller scale; unbelievable pain; debilitated; pain behind her eye so sharp as if her eye would come out; her body was cramped; A spontaneous report was received from a consumer who was also a 55 years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced swelling of the tongue/ Swollen tongue; dizziness/ Dizziness; 103 fever for 2 days/ Pyrexia; shaking literally/ Tremor; like an epilepsy attack in a smaller scale/ Feeling abnormal; fatigued so badly/ Fatigue; patient's body was cramped/ Muscle spasms; couldn't walk/ Gait inability; debilitated/ Asthenia; could only crawl/ Gait inability; vomited two to three hours/ Vomiting; pain behind patient's eye so sharp as if patient's eye would come out/ Eye pain; unbelievable pain/ Pain; type of pain in patient's head far more severe than any migraine patient's ever had; when lying down patient's head felt on fire, when laying on patient's left side patient could feel on the top of patient's head the pain move to the left side/ Headache; when moving to the right side, patient felt liquid in patient's brain pouring to that side/ Feeling abnormal; remained dizzy for several hours, the room was spinning/ Dizziness; my major joints (hip, knee, wrist, elbow, shoulder) were on fire/ Arthralgia; congestion/ Nasal congestion; cough/ Cough; patient felt patient was going to die/ Vaccination complication; brain fog/ Feeling abnormal; terrible time finishing sentences; like brain damage and such a hard time communicating/ Speech disorder. The patient's medical history included migraine which occurred several times a year. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (Batch number: 027L20A)) on 12-Jan-2021. On 11-Feb-2021, approximately ten minutes prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection. On 11-Feb-2021, the patient experienced swelling of the tongue; dizziness; 103 fever for 2 days; shaking literally; like an epilepsy attack in a smaller scale; fatigued so badly; patient's body was cramped; couldn't walk; debilitated; could only crawl; vomited 2-3 hours; pain behind patient's eye so sharp as if patient's eye would come out; unbelievable pain, type of pain in patient's head far more severe than any migraine patient's ever had; when lying down patient's head felt on fire; when laying on patient's left side patient could feel on the top of patient's head the pain move to the left side; when moving to the right side, patient felt liquid in patient's brain pouring to that side; remained dizzy for several hours; the room was spinning; my major joints (hip, knee, wrist, elbow, shoulder) were on fire; congestion; cough and patient felt patient was going to die. On 15-Feb-2021, patient developed brain fog; terrible time finishing sentences; like brain damage and such a hard time communicating. Treatment for the event included one acetaminophen and twelve hours later patient had three ibuprofen. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome for the events the patient experienced swelling of the tongue; dizziness; one hundred and three fever for two days; shaking literally; like an epilepsy attack in a smaller scale; fatigued so badly; patient's body was cramped; couldn't walk; debilitated; could only crawl; vomited two to three hours; pain behind patient's eye so sharp as if patient's eye would come out; unbelievable pain, type of pain in patient's head far more severe than any migraine patient's ever had; when lying down patient's head felt on fire; when laying on patient's left side patient could feel on the top of patient's head the pain move to the left side; when moving to the right side, patient felt liquid in patient's brain pouring to that side; remained dizzy for several hours; the room was spinning; my major joints (hip, knee, wrist, elbow, shoulder) were on fire; congestion; cough and patient felt patient was going to die were recovered on 14-Feb-2021. The outcome of the events brain fog; terrible time finishing sentences; like brain damage and such a hard time communicating were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded..",Not Reported,,Not Reported,Not Reported,,Yes,Y,01/12/2021,02/11/2021,30.0,UNK,,,Medical History/Concurrent Conditions: Migraine (Several times a year.),,,"['Arthralgia', 'Asthenia', 'Cough', 'Dizziness', 'Eye pain', 'Fatigue', 'Feeling abnormal', 'Gait inability', 'Headache', 'Muscle spasms', 'Nasal congestion', 'Pain', 'Pyrexia', 'Speech disorder', 'Swollen tongue', 'Tremor', 'Vaccination complication', 'Vomiting']",UNK,MODERNA, 1065084,PA,76.0,F,"Diverticulitis; This spontaneous report was received from consumer on 18-FEB-2021, concerning a 76 year old female patient who was administered Moderna COVID-19 vaccine9( mRNA-1273). The patient experienced diverticulitis. The patient's medical history was not provided. Concomitant medications included was blood thinners. The patient received suspect product mRNA-1273 on 23 JAN 2021 prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:030L20A) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection. On 4 FEB 2021, approximately within 24 hours of receiving shot, the patient experienced diverticulitis. Treatment history was not reported. Action taken with the dose of mRNA-1273 in response to the event was unknown. The outcome of the event, diverticulitis was considered as unknown.; Reporter's Comments: This case concerns a 76-year-old female who experienced Serious unexpected event of Diverticulitis. The events occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/04/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Diverticulitis'],1,MODERNA,OT 1065085,CT,30.0,M,"Mild nausea; light headache; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, expiry date unknown), intramuscular at the left arm on 29Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced mild nausea and light headache on 30Jan2021 08:00. Events were non-serious. No treatment was received for the adverse events. Facility where the most recent COVID-19 vaccine administered was workplace clinic. The outcome of the events was recovering. Events were non-serious. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Headache', 'Nausea']",1,PFIZER\BIONTECH,OT 1065086,,,M,"has been in contact with his family (wife and child) who tested positive for the coronavirus; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown dates (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient had been in contact with his family (wife and child) who tested positive for the coronavirus and would like to know if he should get his second dose of the Covid vaccine. The outcome of the event exposure to COVID-19 was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Exposure to SARS-CoV-2'],1,PFIZER\BIONTECH,OT 1065087,NY,67.0,M,"very sore arm at the injection site after both doses; Dr. told me that Aspirin was not stopped in the trials; This is a spontaneous report from a contactable physician, the patient. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown for first and second doses) solution for injection intramuscular on an unknown dates (at the age of 67-years-old) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medications included acetylsalicylic acid (ASPIRIN) low dose and ongoing atorvastatin. The patient got a very sore arm at the injection site after both doses but no other side effects. The patient took low dose aspirin and atorvastatin and was concerned that the reason for the lack of side effects was that the medications may have blunted the vaccine immune response. A doctor told the me (patient) that aspirin was not stopped in the trials. The outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN,,,,,"['Circumstance or information capable of leading to medication error', 'Vaccination site pain']",2,PFIZER\BIONTECH,OT 1065088,,,F,"tired; This is a spontaneous report from a contactable healthcare professional, the patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown date (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced felt really tired. The outcome of the event felt really tired was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021145089 same drug/patient, second dose/different AE",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Fatigue'],1,PFIZER\BIONTECH,OT 1065089,TX,,F,arms a little sore; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. Medical history included blood pressure (abnormal). Concomitant medication included verapamil for blood pressure. It was reported that the patient got to receive the first one on the 8th. She did not have any symptoms than her arms a little sore. She got her second dose of Pfizer shot on the 28th and then she guessed the first. Outcome of the event was unknown. Information on lot/batch has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,,,UNK,VERAPAMIL,,Medical History/Concurrent Conditions: Blood pressure abnormal,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1065090,VA,61.0,F,"she experienced a metallic taste; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiration date: May2021), via an unspecified route of administration on the left arm on 30Jan2021 09:00 at a single dose for Covid-19 immunization. The vaccine was administered at the hospital. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Jan2021 for Covid-19 immunization. On 30Jan2021 09:30, she experienced a metallic taste for about 30 minutes after the injection that lasted about an hour with outcome of recovered on 30Jan2021 10:30.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/30/2021,0.0,PVT,,,,,,['Dysgeusia'],2,PFIZER\BIONTECH, 1065091,,,F,"2nd dose was more tired and itchy; 2nd dose was more tired and itchy; Hives; This is a spontaneous report from a contactable consumer (the patient) received from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on an unspecified date as a SINGLE DOSE for covid-19 vaccination. Historical data includes patient received Dose 1 (got tired and was itchy). The patient medical history and concomitant medications were not reported. On an unspecified date , The patient experienced 2nd dose was more tired and itchy and had hives. Consumer wants to know if she should go the Emergency Room 'waited 3 min and cold transferred to D&S Pfizer CEP 2191'. The clinical outcome of the events fatigue, itchy and hives was unknown. Information about Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Fatigue', 'Pruritus', 'Urticaria']",2,PFIZER\BIONTECH, 1065092,SC,,U,"Injection site pain; arm pain; headache; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the second dose of BNT162B2 (UNSPECIFIED TRADE NAME; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On unspecified dates the patient experienced injection site pain, arm pain and headache. The clinical outcomes of injection site pain, arm pain and headache were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Headache', 'Pain in extremity', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1065093,CA,,F,"COVID-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 12Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the Pfizer COVID-19 vaccine on 12Jan2021 (reported as 21 days ago). Tomorrow (02Feb2021) is her second shot. On 16Jan2021 (16 days before the reporting), the patient got COVID-19. The patient was inquiring for the timeline of second dosage. The outcome of the event was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/16/2021,4.0,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 1065094,MA,26.0,M,"fatigue; arm soreness; This is a spontaneous report received from a contactable consumer (patient). A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247, expiry date was unknown), via an unspecified route of administration on right arm on 03Feb2021 11:30 AM at single dose for COVID-19 immunization, at workplace clinic. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 03Feb2021, 18:00, the patient experienced fatigue, arm soreness. Patient was not given treatment for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as recovering. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/03/2021,0.0,WRK,,,,,,"['Fatigue', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1065095,,,F,"Headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (husband) reported for a female patient (wife) with unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 at 1:30pm at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced headache from unspecified date, and the consumer was asking if patient can take Excedrin for pain killer. The outcome of event was unknown. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,,,UNK,,,,,,['Headache'],UNK,PFIZER\BIONTECH, 1065096,MI,,F,"Chill; Body aches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL8982), via an unspecified route of administration, on 21Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was inquiring if she can take paracetamol (TYLENOL) after the first COVID-19 vaccine because she was having body aches after the first injection on 21Jan2021. As of 03Feb2021, the patient was due for her second done on 11Feb2021. The patient had been hearing a myth that she wanted to know if it is true. After the patient's first shot she only had a small side effect which was the body aches. The patient got these about 12 hours after the shot, it happened through the night while she was sleeping. The following morning (22Jan2021), the patient also had what might have been a slight chill but just a slight one, but it was the body aches mostly. The patient took paracetamol (TYLENOL) extended release for the events. Then the patient was told that she shouldn't have taken the paracetamol and that people weren't supposed to take anything after getting the vaccine. The patient asked confirmation if this can't be true and asked what a person would take if they had a fever. The patient confirmed that she did not have a fever. The events subsided immediately, and it was like she never had them; they didn't last long at all. The patient recovered from the events in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,UNK,,,,,,"['Chills', 'Pain']",1,PFIZER\BIONTECH, 1065097,CA,,M,"got the 2nd Covid dose on 12Jan2021 and he stated his IMG was extremely low; This is a spontaneous report from a Pfizer Sponsored Program. A contactable other healthcare professional (patient) reported that a male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 12Jan2021, at a single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) on an unspecified date, for COVID-19 immunisation. On an unspecified date, the patient's immunoglobulins (IMG) were extremely low. He then took a surge test and the report came back negative. He was surprised by this and wanted to know if that is normal. Outcome of the event was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,,,UNK,,,,,,"['Immunoglobulins', 'Immunoglobulins decreased', 'Investigation']",2,PFIZER\BIONTECH, 1065098,NY,36.0,F,"Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; edge is now scaly and dry; edge is now scaly and dry; This is a spontaneous report from a contactable Other Health Professional (patient). A 36-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) on 21Jan2021 (Lot number: El3249) via an unspecified route of administration in the right arm at single doe for COVID-19 immunization. The patient had no medical condition. The patient had no allergies to medications, food, or other products. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Dec2020 08:00 AM (Lot number: EJ1685) via an unspecified route of administration in the left arm for COVID-19 immunization and at 31Dec2020 12:00 PM experienced small rash on left side of chest. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient concomitant medication included Levothyroxine sodium (Euthyrox, Strength: 150ug) and Drospirenone/ethinylestradiol (Nikki, Strength: 3mg/0.02mg). After first shot developed small rash on left side of chest. Persisted for three weeks and was starting to fade when she got second dose. Grew 4-5 times larger, raised, painful, red itched and tender. Now reaches my neck and breasts and shoulders. White normal skin in center, edge was now scaly and dry, itches very badly. Dr won't prescribe steroid fears it will dampen immune response. Taking Allegra, Benadryl and hydrocortisone cream. Does not help. Never had a reaction to a vaccine before. The patient was underwent COVID-19 (Nasal Swab) and PCR at pharmacy (nasal swab) test (test twice weekly for work) both on 29Jan2021 which were negative. The events were assessed as non-serious by the reporter. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,,,PHM,EUTHYROX; NIKKI,,,,,"['Dry skin', 'Erythema', 'Pain of skin', 'Pruritus', 'Rash', 'SARS-CoV-2 test', 'Skin exfoliation', 'Skin reaction']",2,PFIZER\BIONTECH, 1065099,,62.0,F,"tested positive for the Covid virus on 2ndFeb; tested positive for the Covid virus on 2ndFeb; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 3 patients. This is 1st of 3 reports. A 62-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Pharmacy technician, calling on behalf of three patients who tested positive after receiving the first dose of the Covid vaccine, asked when they can get the second dose of the Covid vaccine. They received their first dose on 16Jan2021 and tested positive for the Covid virus on 02Feb2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021140772 same drug/event, different patients;US-PFIZER INC-2021140773 same drug/event, different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,02/02/2021,17.0,UNK,,,,,,"['Drug ineffective', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1065100,,,F,"feeling really bad; pain; tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose,via an unspecified route of administration on 28Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She started ""feeling really bad, having pain, and felt like something ran over her"" after the vaccine was given. She went to her MD and tested positive for Covid-19. She asks, ""Can I take the second dose on 24Feb2021?'The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive. Outcome of event was unknown. Case was assessed as non-serious (Serious: No). Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,,,UNK,,,,,,"['Feeling abnormal', 'Pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1065101,LA,96.0,M,"Headache; Nausea; Eyes are bloodshot red and kind of glaze over; Eyes are bloodshot red and kind of glaze over; He just can't feel real good; This is a spontaneous report from a contactable consumer. A 96-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Jan2021 as a SINGLE DOSE for COVID-19 vaccination. Medical history included heart problems from an unknown date and unknown if ongoing, he has gone over for a battery replacement, pacemaker, and he has eye problems so, he is taking eye drops for those. Concomitant medications included unspecified eye drops. On unspecified date, the patient experienced headache, nausea and his eyes are bloodshot red and kind of glaze over. He just can't feel real good. His eyes are real red and like glaze over. No treatment was received for the events. Outcome of the events headache, nausea, eyes are bloodshot red and kind of glaze over and he just can't feel real good were unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,,,UNK,,,"Medical History/Concurrent Conditions: Eye disorder (He has eye problems. So, he is taking eye drops for those.); Heart disorder; Pacemaker battery replacement (He has gone over for a battery replacement, pacemaker.)",,,"['Glassy eyes', 'Headache', 'Malaise', 'Nausea', 'Ocular hyperaemia']",1,PFIZER\BIONTECH, 1065102,WI,85.0,M,"Facial swelling; I have got Vitallium Partial, there was a pinching, it was very uncomfortable; Gum swelling; This is a spontaneous report from a contactable consumer (patient). This 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number E79262) via an unspecified route on an unspecified date (at the age of 85-years-old) as a single dose in the right upper arm for COVID-19 immunization. Medical history included unspecified health issues. Concomitant medications included unspecified regular medications he took several in the morning and at night. The patient also took vitamins ""and different things like that"" from unspecified dates for unspecified indications. The patient experienced facial swelling and gum swelling on an unspecified date. The patient had a Vitallium partial. The metal and the partial denture were pinching him; it was very uncomfortable. The patient stated it was not a life or death situation but he was ready to go to the dentist for an adjustment in the partials so it didn't hurt. The patient did not undergo any lab tests. The patient did not receive treatment for the events. The outcome of facial swelling and gum swelling was unknown. No follow-up attempts are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PVT,VITAMINS NOS,,,,,"['Dental discomfort', 'Gingival swelling', 'Swelling face']",UNK,PFIZER\BIONTECH, 1065103,NY,24.0,F,"mild fever; body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on an unknown date (at the age of 24-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included anxiety and depression. Concomitant medication included escitalopram oxalate (LEXAPRO). Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination in Jan2021 and experienced body chills. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date, the patient experienced mild fever and body aches. The outcome of the events mild fever and body aches was unknown. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021144818 same reporter/patient/vaccine, different dose/event",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PVT,LEXAPRO,,Medical History/Concurrent Conditions: Anxiety; Depression,,,"['Pain', 'Pyrexia']",2,PFIZER\BIONTECH,OT 1065104,,,F,"pain in her arm; This is a spontaneous report from a contactable healthcare professional, the patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on an unknown date (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on an unknown date and experienced she felt really tired. On an unknown date, the patient experienced pain in her arm. The outcome of the event pain in her arm was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093322 same drug/patient, different dose/AE",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain in extremity'],2,PFIZER\BIONTECH,OT 1065105,MO,62.0,M,"Allergies; Sinus problems; Dizziness when he is up and moving around; Equilibrium is off; Fatigued; This is a spontaneous report from a contactable consumer (patient who is a transit operator). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5318), via an unspecified route of administration in right arm, on 25Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included ongoing urinary incontinence (use of medication that does not make him run to the bathroom and helps him hold his urine), ongoing acne, drowsy, and ongoing flow of urine or weak bladder. The patient's concomitant medications included fesoterodine fumarate (TOVIAZ; Expiration Date: 04Dec2021) (about 2 weeks prior to getting the COVID-19 vaccine) for urinary incontinence, doxycycline (Expiration Date: 26Nov2021; makes him drowsy) for acne, and tamsulosin (Expiration Date: 12Nov2021) for flow of urine or weak bladder; all from Jan2021 and ongoing. The patient does not take any of these medications while driving. The patient took his first Pfizer COVID-19 shot on 25Jan2021 (Monday). The patient had been experiencing dizziness which started a few days after getting the vaccine (Jan2021). The patient was supposed to work from Tuesday to Friday, but he did not go into work on Wednesday. The patient was unsure of the specific day the dizziness started. The patient did have allergies (unspecified date), but when he called in his doctor, he sent him a medication for allergies, meclizine (Expiration Date: 28Jan2022). Normally, the medication takes a couple days to make him feel better. After he took meclizine for dizziness, he feels better. The patient notices the dizziness when he is up and moving around. The patient can tell something is off, like his equilibrium is off in Jan2021. It may not be due to the shot, but looking at the paper it says tiredness, which he has been feeling fatigued (also started a few days after the vaccine, but he is unsure specifically what day) and dizziness, which he has in Jan2021. The medication he is taking (meclizine), can also do the same thing, but never for this long. When he takes it, it normally makes him feel better after a few days. The patient has sinus problems as well on an unspecified date, but never lasting this long. The patient had not started feeling better since taking the medication, meclizine (as reported). The patient also said that meclizine could be causing the fatigue because it does make his drowsy and he just sleeps when he takes it - he cannot take it when he drives. The patient would go back for the second dose on 15Feb2021. The patient was recovering from ""Dizziness when he is up and moving around"". The outcome of ""Allergies"" was unknown. The patient had not recovered from the remaining events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/01/2021,,UNK,TOVIAZ; DOXYCYCLINE; TAMSULOSIN,Acne; Bladder disorder; Urinary incontinence (Use of medication that does not make him run to the bathroom and helps him hold his urine),Medical History/Concurrent Conditions: Drowsiness,,,"['Balance disorder', 'Dizziness postural', 'Fatigue', 'Hypersensitivity', 'Sinus disorder']",1,PFIZER\BIONTECH, 1065106,PA,63.0,M,"headache; mild intermittent fatigue; This is a spontaneous report from a non-contactable consumer (patient himself). A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201), intramuscularly in left arm on 07Feb2021 11:30 AM at single dose for COVID-19 immunization in facility type other. The patient's medical history included heart disease, type 2 diabetes mellitus, throat cancer. The patient did not have allergies to medications, food, or other products. Concomitant medications included atorvastatin calcium (LIPITOR) at 40 mg daily, clopidogrel bisulfate (PLAVIX) at 75 mg daily, metformin at 500 mg daily, lisinopril at 5 mg daily, ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, lycopene, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium molybdate, sodium selenate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc oxide (CENTRUM FORTE) at 1 DF (Dosage Form) daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 07Feb2021 13:00, the patient experienced headache post dose x 1-2 hours (resolved after taking a short nap) and mild intermittent fatigue post dose x 4 days (recovering). The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the event headache was resolved on 07Feb2021 and recovering for the other event. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/07/2021,02/07/2021,0.0,UNK,LIPITOR; PLAVIX; METFORMIN; LISINOPRIL; CENTRUM FORTE,,Medical History/Concurrent Conditions: Heart disorder; Throat cancer; Type 2 diabetes mellitus,,,"['Fatigue', 'Headache']",1,PFIZER\BIONTECH,OT 1065107,NY,74.0,F,"Blood pressure feels really high; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 16Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 virus in the past year (2020) from which her husband died last year (2020), receiving occupation therapy (OT) at home, and stroke (in the past). The patient's concomitant medications were not reported. The patient received her first Pfizer COVID-19 vaccine dose on 16Jan2021 and is scheduled to receive her next COVID-19 vaccine booster on 06Feb2021. The last time the patient had her COVID-19 virus antibody blood work was on 11Jan2021, and her COVID-19 virus antibodies were down to 1.9 from 8 (on an unspecified date). The patient's COVID-19 virus antibodies have been progressively going down since she was first being tested for them. The patient received a call today that her occupational therapist tested positive for the COVID-19 virus. Both her occupational therapist and she were wearing masks when working together. The patient received the call today because she was exposed to the occupational therapist. The patient asked if she can still take the COVID-19 vaccine booster that she is scheduled for on Saturday (06Feb2021). The patient really wanted to get the COVID-19 vaccine booster on 06Feb2021. The patient was going to be speaking with a trained healthcare professional when she is transferred to Pfizer medical information. Anyone the patient has spoken to about getting her second COVID-19 vaccine has not been willing to answer her questions. The patient's blood pressure feels really high now (02Feb2021), and she has had a stroke in the past. The outcome of the event was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,02/02/2021,17.0,UNK,,,Medical History/Concurrent Conditions: COVID-19 (Husband died from COVID-19 virus); Death of husband (From COVID-19 virus); Occupational therapy (At home); Stroke (In the past),,,"['Blood pressure measurement', 'Hypertension', 'SARS-CoV-2 antibody test']",1,PFIZER\BIONTECH, 1065108,FL,73.0,F,"Arm is slightly stiff; Muscle is slightly sore; Sore arms; just little tender; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 01Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included medroxyprogesterone and estradiol. The patient previously took the first dose of BNT162B2 in Jan2021 for COVID-19 immunization (got the first shot exactly 3 weeks before for which the patient was not sure of the date). On 01Feb2021, just shortly after the patient and his husband both got the shot, the patient had sore arms by the time they drove home yesterday afternoon. The patient's sore arm was much better today but it was still just little tender - that is the only thing she had. Currently (02Feb2021), the patient's arm was slightly stiff still, just the muscle is slightly sore. No treatment was taken for the adverse events. The patient was recovering from ""Sore arms; just little tender"". The outcome of the other events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,UNK,MEDROXYPROGESTERONE; ESTRADIOL,,,,,"['Musculoskeletal stiffness', 'Myalgia', 'Pain in extremity']",2,PFIZER\BIONTECH, 1065109,NJ,78.0,M,"shivering/having in and out chills; slight fever; fever, headache, dry heaves, fatigue, and crazy dreams; Adding strange dreams/crazy dreams/ so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up; hands were cold; headache fades in and out; Dry heaves; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EM5318, via an unspecified route of administration in the right arm on 08Feb2021 at 11:45 (at the age of 78-years-old) as a SINGLE DOSE for Covid-19 Vaccination. Historical vaccine includes BNT162B2 Dose 1, Lot Number 'He thinks its EL3302'. The patient had no known medical history or allergies. Concomitant medication included metoprolol tartrate (METOPROLOL TARTRATE), lisinopril (LISINOPRIL), atorvastatin (LIPITOR [ATORVASTATIN]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Late on Wednesday 10Feb2021 The patient experienced his hands were cold, he went to bed and he was shivering, he had to put on clothes and 3 quilts and in the meantime he was having in and out chills and slight fever, fatigue and crazy dreams/so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up/three types all repeating four or more times and on Feb2021 experienced headache fades in and out and dry heaves. The patient underwent lab tests and procedures which included pyrexia: little high (using the strips on his forehead) on an unspecified date. As a result of the event abnormal dreams patient did visit a professional office/clinic visit. No treatment was given for the event. The clinical outcome of the event shivering/having in and out chills, slight fever, dry heaves, fatigue, headache and hands were cold were unknown while abnormal dreams was recovered Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/01/2021,,UNK,METOPROLOL TARTRATE; LISINOPRIL; LIPITOR [ATORVASTATIN],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Abnormal dreams', 'Chills', 'Fatigue', 'Headache', 'Peripheral coldness', 'Pyrexia', 'Retching']",2,PFIZER\BIONTECH, 1065111,FL,71.0,M,"Very sick, then hospitalized Died; This is a spontaneous report from a contactable Other Health Professional (patient). A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 28Jan2021 06:00 at single dose for COVID-19 immunization. Medical history included Esrd controlled a-fib. Concomitant medication in two weeks included diphenhydramine hydrochloride (BENADRYL) before vaccine and some dialysis Ned maybe. Facility type vaccine: Other. If other vaccine in four weeks: No. If covid prior vaccination: No. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced very sick on 29Jan2021. The patient was not recovered from the event very sick. Event reported as Very sick and my father died. AE resulted in: Emergency room/department or urgent care, Hospitalization. AE treatment: Famotidine and nausea meds then hospitalized Died. It was unknown if an autopsy was done. Information on batch/lot number has been requested.; Sender's Comments: The limited information provided precludes a full clinical assessment of the case. Significant in the assessment would be the date when the first dose of the vaccine was given, the patient's complete medical history, and the full clinical course of the event (including specific symptoms/events associated with reported 'very sick'), which were unknown at the time of this report. This case will be reassessed once with additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Very sick, then hospitalized Died",Yes,,Not Reported,Yes,,Not Reported,N,01/28/2021,01/29/2021,1.0,UNK,BENADRYL,,Medical History/Concurrent Conditions: Atrial fibrillation,,,['Illness'],2,PFIZER\BIONTECH, 1065112,,,F,"she lost her hearing in her left ear and her equilibrium is completely off; she lost her hearing in her left ear and her equilibrium is completely off; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 13Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Last night (13Feb2021), the patient lost her hearing in her left ear and her equilibrium was completely off. She was asking for guidance as she cannot reach her doctor. The outcome of the events was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/13/2021,0.0,UNK,,,,,,"['Balance disorder', 'Deafness unilateral']",UNK,PFIZER\BIONTECH, 1065113,CO,20.0,F,"barely able to stand; swollen lymph nodes; irregular heartbeat; severe upper back and neck pain; severe upper back and neck pain; She has barely been able to move for several weeks; dizzy; vertigo; headache; This is a spontaneous report from a contactable consumer, the patient's parent. A 20-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 25Jan2021 at 10:30 AM (at the age of 20-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to eggs. Historical vaccination included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 04Jan2021 at 10:30 AM (at the age of 20-years-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The vaccine was administered in a hospital. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The reporter explained that the patient's adverse events ""started as expected"" with a headache side effect (date not specified), however two days after the vaccine, while working as an EMT the patient became very dizzy and had to stop work. She remained dizzy, like vertigo, the next day but attempted to go to work. Her co-worker could see she wasn't right and took her to the hospital. The patient spent two days in the hospital, barely able to stand, getting a head MRI with contrast, evaluated for vertigo, blood tests, and they did not find anything and gave her vertigo medicine and sent her home. She has since had shifting symptoms, swollen lymph nodes, irregular heartbeat, severe upper back and neck pain. She has barely been able to move for several weeks and has seen an ENT doctor, another emergency doctor, and her regular doctor. None have found any other cause and have tried treating her with steroids. The events were treated with Meklazine and unspecified steroids. Lab data included SARS-CoV-2 test COVID 19 testing on 28Jan2021 which was negative. The clinical outcomes of headache, dizziness, vertigo, difficulty standing, swollen glands, irregular heart rate, back pain, neck pain and unable to more for several weeks were reported as not recovered. The patient was tested for COIVD-19 after the vaccination, on 28Jan2021, and was found to be negative.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/25/2021,01/01/2021,,PVT,,,Medical History/Concurrent Conditions: Food allergy,,,"['Back pain', 'Blood test', 'Dizziness', 'Dysstasia', 'Headache', 'Heart rate irregular', 'Lymphadenopathy', 'Magnetic resonance imaging', 'Mobility decreased', 'Neck pain', 'SARS-CoV-2 test', 'Vertigo']",2,PFIZER\BIONTECH, 1065114,GA,70.0,F,"Lost consciousness for brief period; bleeding from small gash in head; broke my finger; feeling out of sorts; feeling light headed; This is a spontaneous report from a contactable consumer (patient) who reported that a 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number:EL3246), via an unspecified route of administration into the right arm on 10Feb2021 07:45 at a single dose for COVID-19 immunisation. Medical history included known allergies to CT dye, COVID-19 from an unknown date prior to vaccination and known allergies to sulfa drugs. Patient was not pregnant. Patient had unspecified concomitant medications. On 11Feb2021 08:00, patient woke up feeling out of sorts and feeling light headed, patient sat down and the next thing she knew she was on the floor bleeding from a small gash in her head, she lost consciousness for a brief period and also broke her finger. The events required emergency room and physician office visit. The patient had 3 staples in her head and a finger splint for the events ""bleeding from a small gash in her head"" and ""broke her finger"". Outcome of events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/11/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Contrast media allergy; COVID-19 (prior to vaccination); Sulfonamide allergy,,,"['Dizziness', 'Hand fracture', 'Loss of consciousness', 'Malaise', 'Skin laceration']",1,PFIZER\BIONTECH, 1065115,AL,59.0,F,"racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break; joints and bones felt like they were going to break; no appetite; weakness, unable to get up out of bed; unable to get up out of bed; patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); tired; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL3302 and expiry date unknown, via unspecified route of administration on 09Feb2021 at single dose for Covid-19 immunization in a workplace clinic. Medical history included sjogrens disease/syndrome (immune disease), sulfa allergies. The patient's concomitant medications included several medications daily. The patient previously took morphine and experienced allergies and made her sick. Historical vaccine included first dose of BNT162B2, lot number EJ 1686 on 15Jan2021 for Covid-19 immunization. The patient has no Covid prior vaccination. On 09Feb2021 11:00 am (also reported as started 12 hours after 2nd shot), she experienced fever 103, hard chills, racing heart, headache, joints and bones felt like they were going to break, no appetite, weakness, unable to get up out of bed. The patient informed that the hardest time and highest fever was 11 PM to 6 AM Tue/Wed. The chills were severe, felt like her spine would snap into. The patient was still sick Wed (10Feb2021), the fever was not as high 101 to 102. The patient informed that what was scary was heart racing for hours that first night. The patient thought she was going to die. The patient informed that she didn't have heart problems, but she has Sjogrens, an immune disease. The patient informed that the fever was finally back to normal on Thursday (11Feb2021) afternoon after getting shot Tuesday noon. The patient informed that it's Sunday (14Feb2021) and she was still tired and has headache. The patient informed that it has to be something to do with Sjogrens. The patient informed that her rheumatologist said nobody so far had the kind of fever/reactions she had. The patient has not Covid tested post vaccination. The patient has explicit consent. The patient did not received treatment due to the events. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event ""racing heart"" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/01/2021,,WRK,,,"Medical History/Concurrent Conditions: Sulfonamide allergy; Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: Sjogrens Disease/Syndrome, Comment: immune disease",,,"['Arthralgia', 'Asthenia', 'Body temperature', 'Bone pain', 'Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Movement disorder', 'Off label use', 'Palpitations', 'Product use issue', 'Pyrexia']",2,PFIZER\BIONTECH, 1065116,CA,33.0,F,"pneumonia; Fever; chills; nausea; difficulty breathing; This is a spontaneous report from a contactable other HCP (patient). A 33-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 11:00 at a single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient experienced fever, chills, nausea, pneumonia, and difficulty breathing on 11Feb2021 23:00 with outcome of recovering. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was not diagnosed of covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab test post vaccination: negative on 13Feb2021. Therapeutic measures were taken as a result of events (antibiotics, IV fluids, Tylenol). The patient received second dose (Lot Number: EN6201) on 12Feb2021 12:00 PM in the left arm.; Sender's Comments: There is a reasonable possibility that the events fever, chills, and nausea were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the events pneumonia and difficulty breathing with Bnt162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,02/11/2021,21.0,PUB,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Dyspnoea', 'Nausea', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1065117,MN,,F,"Gastrointestinal bleeding; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program COVAX US Support reported reporter's sister. A female patient of an unspecified age (reported as 77) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced gastrointestinal bleeding on 04Feb2021 with outcome of recovering. The patient was hospitalized for gastrointestinal bleeding from 04Feb2021 to 09Feb2021. The patient received the 1st dose of the vaccine and is due for the 2nd dose on 18Feb2021. The patient was admitted in the hospital on 04Feb2021 for Gastrointestinal bleeding, was discharged on 09Feb2021 but was back in the ER on 10Feb2021. The patient was nearing recovery. The reporter denied that this was a side effect of the vaccine. The reporter was asking if it would be okay for her sister to take the 2nd dose as scheduled. Information on the lot/ batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. There is no evidence or argument to suggest a causal relationship between the suspect vaccine BNT162B2 and the event gastrointestinal bleeding. The event is likely due to an underlying medical condition.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,,02/04/2021,,UNK,,,,,,['Gastrointestinal haemorrhage'],1,PFIZER\BIONTECH, 1065118,WA,58.0,F,"Blood clot in lower left leg; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on the left arm, at age 58 years, first dose on 23Jan2021 14:00 at single dose for COVID-19 vaccination. Medical history was reported as none. Patient had no known allergies. The patient is not pregnant. There were no concomitant medications. There were no other vaccines administered in four weeks and no other medications taken in two weeks. On 30Jan2021, patient experienced blood clot in lower left leg. ER doc indicated that patient had no reason to have formed a clot given the medical history, health, weight, age, diet, no surgeries, no prior injury, etc. Facility type vaccine was administered at a Public Health Clinic/Veterans Administration facility. Event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event includes rivaroxaban (XARELTO) as blood thinner. The outcome of the event was not recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/30/2021,7.0,PUB,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Thrombosis'],1,PFIZER\BIONTECH, 1065119,MA,76.0,F,"appendicitis; intense abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 06Feb2021 15:45 (03:45 PM) at a single dose as Covid vaccine. Medical history included gastrointestinal distress at the time of incident. The patient had no known allergies. Concomitant medications included cyanocobalamin (B12), calcium, levothyroxine sodium (LEVOXYL), lisinopril, and ergocalciferol (VIT D). The patient developed intense abdominal pain on 08Feb2021 10:00 AM. She went to the ER on 09Feb2021 and a CT scan on 09Feb2021 which revealed that she had appendicitis on 08Feb2021 10:00 AM. The patient was hospitalized for the events from 09Feb2021 to 13Feb2021 (4 days of hospitalization). Treatment for the events included intravenous antibiotics. The patient had no Covid prior to vaccination. Additional lab data included Covid test type post vaccination Nasal Swab with negative result on 09Feb2021 (Covid tested post vaccination). The outcome of the events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/06/2021,02/08/2021,2.0,PHM,B12 [CYANOCOBALAMIN]; CALCIUM; LEVOXYL; LISINOPRIL; VIT D,,Medical History/Concurrent Conditions: Gastrointestinal disorder (gastrointestinal distress at the time of incident),,,"['Abdominal pain', 'Appendicitis', 'Computerised tomogram', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1065120,AZ,50.0,F,"almost blacked out; Dizzy; sweating; turned very pale; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: LE9267, expiration date unknown) via an unspecified route of administration in the left arm on 13Feb2021, 09:45AM (at 50 years old) at a single dose for COVID-19 immunization. The patient was not pregnant when vaccinated in Other Vaccination Facility Type. Medical history included high blood pressure and allergies to Biaxin and Amoxicillin; all from an unknown date and unknown if ongoing. Concomitant medications included calcium, lisinopril, colecalciferol (VITAMIN D) which were received within 2 weeks of vaccination. At 50 years old, the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL1283, expiration date unknown) via an unspecified route of administration in the left arm on 23Jan2021, 09:00AM at a single dose for COVID-19 immunization. The patient was not diagnosed with COVID prior to vaccination, did not receive any other vaccines within 4 weeks prior to BNT162B2, and was not tested for COVID post vaccination. On 14Feb2021 09:45, the patient experienced dizzy, sweating, turned very pale, and almost blacked out. No therapeutic measures were taken as a result of the adverse events. The patient recovered from the events on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/14/2021,1.0,UNK,CALCIUM; LISINOPRIL; VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: Blood pressure high,,,"['Dizziness', 'Hyperhidrosis', 'Loss of consciousness', 'Pallor']",2,PFIZER\BIONTECH, 1065121,FL,,F,"petechiae on the skin; conjunctival hemorrhage; This is a spontaneous report from a contactable Consumer reporting for her mother in law. A 72-years-old female patient received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 12Feb2021 at single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 vaccine on an unknown date. The patient experienced conjunctival hemorrhage on 13Feb2021 with outcome of unknown , petechiae on the skin on 14Feb2021 described as round, red spots on the arm, leg, and belly with no more than 6 spots, with outcome of unknown. Conjunctival hemorrhage was considered an Important Medical Event. Information about Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/13/2021,1.0,UNK,,,,,,"['Conjunctival haemorrhage', 'Petechiae']",2,PFIZER\BIONTECH, 1065122,CA,90.0,M,"unable to stand or walk; Legs no longer able provide support; mentally increased disorientation at times; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262) on 01Feb2021 at 15:00 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 05Feb2021 4 days after vaccine, patient was unable to stand or walk with rolling walker. Prior to vaccine, patient was able to ambulate slowly with rolling walker. Legs no longer able provide support. Also mentally increased disorientation at times. Patient visited doctor office due to the events considered as disabling. At the time of the reporting the patient had not yet recovered from the events.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/01/2021,02/05/2021,4.0,PVT,,,,,,"['Disorientation', 'Gait inability', 'Muscular weakness']",1,PFIZER\BIONTECH, 1065123,GA,82.0,F,"gets 102 degree fever; Could not speak much next two days; Within one hour or so after: found on floor, fell on right side; unable to speak like a TIA; disoriented; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021 at 13:00 at single dose for COVID-19 immunisation at the age of 82-year-old. Medical history included dementia, high blood pressure, allergy to drugs with sulfer. Concomitant medications included 2.5 Amlodipine, 81 mg aspirin, 0.5 clonazepam, 20 mg Escitalopram, 10 mg melatonin, 5 mg memantine, 15 mg mirtazapine. The patient was not pregnant. The patient received first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 at single dose for COVID-19 immunisation at the age of 82-year-old. Within one hour or so after the vaccine administration: the patient was found on floor, fell on right side, disoriented, unable to speak like a transient ischemic attack (TIA), out of it. The patient could not speak much next two days. Don 14Feb21 at 15:00, the patient got 102-degree fever. The patient was treated for the events. The patient was recovering from the events. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,SEN,AMLODIPINE; ASPIRIN [ACETYLSALICYLIC ACID]; CLONAZEPAM; ESCITALOPRAM; MELATONINE; MEMANTINE; MIRTAZAPINE,,Medical History/Concurrent Conditions: Dementia; Hypertension; Sulfonamide allergy,,,"['Body temperature', 'Disorientation', 'Fall', 'Pyrexia', 'Speech disorder', 'Transient ischaemic attack']",2,PFIZER\BIONTECH, 1065124,NC,76.0,M,"Chills; Headache; extremely weak; has not felt like eating anything; This is a spontaneous report from a contactable nurse reporting for her husband. A 76-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL9264), via an unspecified route of administration in the deltoid right, on 03Feb2021 at 15:00, at single dose, for COVID-19 immunisation. Medical history included cardiac disorder from 2007 and ongoing, cholecystectomy on 21Dec2020, stent placement from Dec2020 to Jan2021 (stents placed on 27Dec2020 or 28Dec2020, in Jan2021 it was removed), hospitalisation from Dec2020 to Jan2021 (for 11 days), ongoing weakness (weakened state). The reporter explained that her husband had some big issues from Nov2020 to Jan2021 which ended in the removal of a dead gallbladder that was gangrene and had to have stents placed. He was in a weakened state already. There were no concomitant medications. No other vaccines were administered on the same date or 4 weeks prior. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1283) on 13Jan2021, for COVID-19 immunisation, with no adverse effect. The patient experienced chills on 08Feb2021 with outcome of not recovered, headache on 08Feb2021 with outcome of not recovered, extremely weak on 08Feb2021 with outcome of not recovered, has not felt like eating anything in Feb2021 with outcome of not recovered. The events chills, headache and extremely weak were considered medically significant. Therapeutic measures were taken as a result of chills and included treatment with Tylenol. The reporter assessed the events as related to vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/01/2021,,OTH,,"Heart disease, unspecified; Weakness (Weakened state)",Medical History/Concurrent Conditions: Gallbladder removal; Hospitalization (For 11 days); Stent placement (Stents placed on 27Dec2020 or 28Dec2020. In Jan2021 it was removed.),,,"['Asthenia', 'Chills', 'Decreased appetite', 'Headache']",2,PFIZER\BIONTECH, 1065125,NJ,43.0,F,"heart rate jumped up; thought she was going to pass out; eyes were blurry; This is a spontaneous report from a contactable consumer. A 43-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264) on 10Feb2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included autoimmune issues diagnosed in 2006-2007. Concomitant medications were not reported. After 4 days from vaccination on 14Feb2021 the patient experienced blurred vision, increased heart rate, and feeling that she will pass out (as such) . She went to the Emergency Room and they did two EKGs, two COVID tests, and blood work to check the enzymes in her blood for her cardiac muscle, but there was no reason, nothing they could find about why her heart rate spiked. Patient also reported that her heart rate went up from about 03:00PM up thru midnight last night, and was still not down completely, it was a little erratic, but it was better than it was. She was prescribed treatment at the hospital to bring her heart rate down, but they didn't want to give her more and risk lowering her blood pressure. Patient was monitored through the night, and she was supposed to see a cardiologist there but they didn't show up, so she put a phone call in to hers. She was admitted to the hospital overnight. The patient recovered from the events on an unspecified date.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/10/2021,02/14/2021,4.0,UNK,,,Medical History/Concurrent Conditions: Autoimmune disorder (diagnosed in 2006-2007),,,"['Blood test', 'Dizziness', 'Electrocardiogram', 'Heart rate', 'Heart rate increased', 'SARS-CoV-2 test', 'Vision blurred']",1,PFIZER\BIONTECH, 1065126,,88.0,M,"kidney infection; This is a spontaneous report from a contactable consumer or other non hcp. A 88-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 09Feb2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced kidney infection on an unspecified date. Patient started on sulfamethoxazole/trimethoprim. The outcome was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,,,UNK,,,,,,['Kidney infection'],2,PFIZER\BIONTECH, 1065127,SC,,F,"tested positive; tested positive/experienced more like a cold; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect from a contactable consumer (patient). A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had my first shot last month. Her 2nd shot on 12th Feb, daughter came with Covid tested positive, also her co-worker. 1st of Feb. She was also tested positive. She experienced more like a cold, She would like to know if she should take the 2nd shot.The patient underwent lab tests and procedures which included sars-cov-2 test: positive in Feb2021. Outcome of events was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,02/01/2021,31.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1065128,,,F,"cardiac events/cardiac issues; This is a spontaneous report from a contactable Nurse. A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 as a single dose for COVID-19 immunisation, lot number: unknown. Medical history and concomitant medications were not provided. It was reported that patient was hospitalized on unknown date due to cardiac events/ cardiac issues (onset date unknown). The nurse was caring for a patient who received the first (1 st) dose of the vaccine in the beginning of Jan2021, then wound up sick and in the hospital. The patient's second (2 nd) dose was due around the 20th or 21Jan2021, but the patient missed the dose due to being in the hospital. Nurse wanted to know if patient should she be getting the 2nd dose now or restarting the series. Nurse stated that the patient did not have an adverse event to the vaccine; she had unrelated cardiac issues. Outcome of the event was unknown. information about Lot/ Batch number requested.; Sender's Comments: The reported cardiac disorder was most likely an intercurrent/concurrent disease, and unrelated to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).",Not Reported,,Not Reported,Yes,,Not Reported,U,01/01/2021,,,UNK,,,,,,['Cardiac disorder'],1,PFIZER\BIONTECH, 1065129,WA,54.0,M,"tunnel vision; warm sensation travel from the left shoulder area to my chest/upper stomach; eyes burned; could taste something; heart rate became rapid at a steadily increase amount (113 bpm)/pulse stayed at 92-94 BPM for approximately two hours; felt dizzy; lost speed sensation in the car I was driving; This is a spontaneous report from a contactable consumer (patient himself). A 54-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6201), via an unknown route, on 12Feb2021 (at 12:45) at a single dose in the left arm for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included atrial fibrillation from Jun2020, ablation surgery for atrial fibrillation on unknown date, ongoing atrial tachycardia, and ongoing premature ventricular contractions (PVCs). Past drug history included allergy to penicillin. Relevant concomitant medications included vitamin NOS, mineral NOS (MEGA MEN) and amino acids NOS, carotenoids NOS, herbal NOS, hyaluronic acid, methylsulfonylmethane, minerals NOS, vitamins NOS (GNC MEGA MEN SPORT). Within approximately two minutes of receiving the shot, he felt a warm sensation travel from the left shoulder area to his chest/upper stomach, his eyes burned, he could taste something, and his heart rate became rapid at a steadily increase amount. He watched his heart rate tick up on her watch to approximately 113 BPM. His normal resting heart rate was upper 60s. He felt dizzy and out of it for about 30 minutes. He felt like he had tunnel vision and lost speed sensation in the car he was driving. His pulse stayed at 92-94 BPM for approximately two hours. He wasn't anxious about getting the shot and had actually been looking forward to it. The patient was not treated for the events. The patient had recovered from 'felt dizzy' on 12Feb2021 while the remaining events resolved in Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,UNK,MEGA MEN; GNC MEGA MEN SPORT,Atrial tachycardia; Premature ventricular contractions,Medical History/Concurrent Conditions: Atrial fibrillation (Ablation surgery for AFIB); Cardiac ablation (Ablation surgery for AFIB); Penicillin allergy,,,"['Dizziness', 'Eye irritation', 'Feeling hot', 'Heart rate', 'Heart rate increased', 'Sensory loss', 'Taste disorder', 'Tunnel vision']",1,PFIZER\BIONTECH, 1065130,NC,81.0,M,"injection site swelling; heart rate increased (95 bpm); jumping heart rhythm; Weakness; coughing while trying to take a full breath; sore right arm; This is a spontaneous report from a contactable consumer reporting for himself. An 81-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EN6201), via an unspecified route of administration in the right arm, on 11Feb2021 at 11:45, at single dose, for COVID-19 immunisation. Medical history included ulcer haemorrhage, ongoing arthritis, blood pressure abnormal, coagulopathy, surgery (for his chronic arthritis in the neck and shoulder), cardiac disorder (with heart aneurysm and a murmur). Concomitant medications included indapamide (unknown manufacturer) for blood pressure abnormal, acetylsalicylic acid (ECOTRIN 81 MG) for anticoagulant therapy, potassium (unknown manufacturer), candesartan (unknown manufacturer) for blood pressure abnormal, clorazepate dipotassium (TRANXENE) for muscle relaxant therapy for his chronic arthritis in the neck and shoulder. The patient experienced jumping heart rhythm on 15Feb2021 with outcome of not recovered, weakness on 15Feb2021 with outcome of recovered, coughing while trying to take a full breath on 15Feb2021 with outcome of recovered, sore right arm on 11Feb2021 with outcome of recovering, injection site swelling on an unspecified date with outcome of unknown, heart rate increased (95 bpm) on 15Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included heart rate: 95 bpm on 15Feb2021, prostatic specific antigen (PSA): unknown result on 03Feb2021. Therapeutic measures were taken as a result of sore right arm and included treatment with Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,UNK,INDAPAMIDE; ECOTRIN 81 MG; POTASSIUM; CANDESARTAN; TRANXENE,Chronic arthritis,"Medical History/Concurrent Conditions: Blood pressure abnormal; Coagulation disorder; Heart disease, unspecified (with heart aneurysm and a murmur); Surgery (for his chronic arthritis in the neck and shoulder); Ulcer bleeding",,,"['Arrhythmia', 'Asthenia', 'Cough', 'Heart rate', 'Heart rate increased', 'Injection site swelling', 'Prostatic specific antigen', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1065131,CA,56.0,F,"abdominal pain; mild muscle soreness at site; Fatigue; never feels rested or wants/needs to sleep; This is a spontaneous report from a contactable Consumer (patient). A 56-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 56-year-old) on 21Jan2021 as a single dose for COVID-19 immunisation, lot number: EL8982. Medical history included gall bladder, liver disease (diagnosed in 2008, 2017 exam fully functional), Umbilical (umb) hernia and ulcer. Patient had allergy-severe hives caused by plasma transfusion. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Other medications within two weeks prior to the vaccination was reported as not applicable (N/A). On 21Jan2021 patient received the first dose, following day (22Jan2021) mild muscle soreness at site, ongoing fatigue, never felt rested or wanted/needed to sleep, a lot. Noticed abdominal pain, did not connect the two. All events considered serious due to disability or permanent damage. No treatments received for the events. Prior to vaccination the patient was not diagnosed with COVID-19. Patient was not tested for Covid post vaccination. Since the vaccination patient had not been tested for COVID-19. Patient had not recovered from the event fatigue and recovered with sequel (recovered with lasting effects) from the other mentioned events.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/21/2021,01/22/2021,1.0,UNK,,,"Medical History/Concurrent Conditions: Gallbladder disorder; Liver disorder ((diag.2008, 2017 exam fully functional)); Ulcer; Umbilical hernia",,,"['Abdominal pain', 'Fatigue', 'Liver function test', 'Myalgia', 'Sleep disorder']",1,PFIZER\BIONTECH, 1065132,OH,46.0,F,"sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints hurt; very large lymph node swelling on left (neck/collarbone/under arm).; cough; Spoke to MD regarding feet as it was difficult to walk; vaginal bleeding; headache; fever 101.9; felt like I was in shock; uncontrollable shaking; fast breathing; freezing; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 10Feb2021 at 11:00 AM (at the age of 46-year-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to sulfa drugs. The patient has pins in both feet from prior surgery. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ) on 19Jan2021 at 11:30 AM (at the age of 46-year-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient stated that it was unknown if prior to the vaccination, she had COVID-19. The vaccine was administered in a Nursing Home facility. Concomitant medications were not reported. The patient did not receive other vaccines within four weeks prior to the COVID vaccination. On 11Feb2021 the patient awoke at 1:30 AM with uncontrollable shaking, fast breathing, and she was freezing. She had no temperature at that time, almost felt like she was in shock. She took a shower and got calmed down. She was very nauseous but able to go back to sleep. At 04:30 AM she awoke again, this time with headache and a fever of 101.9. She continued with a fever in the 101.1 to 101.9 range for remainder of the day. The next day, 12Feb2021, she awoke feeling better and no fever but she had welts on her toes and her feet were swollen. Both feet and hand joints hurt and she had very large lymph node swelling on left (neck/collarbone/under arm). She also had developed a cough. She spoke to her MD regarding her feet as it was difficult to walk. They directed her to the Emergency Room (ER). The ER staff said to watch for two days. Later that evening (12Feb2021) she started having some shortness of breath and vaginal bleeding. She has an IUD and has not had a period for four years. She called the ER and they gave same advice. She had no fever that day (13Feb2021) but she woke around 3:30 AM soaked. As of 14Feb2021 she was still short of breath on/off and still has sore feet. The patient did not receive treatment for the events. Lab data included Fever of 101.9 on 11Feb2021 and fever in the 101.1 to 101.9 range also on 11Feb2021. The clinical outcome of shortness of breath was reported as not recovered. The clinical outcome of shock-like symptom, shaking, fast breathing, feeling cold, nauseous, headache, fever, welts, swelling of feet, arthralgia, lymphadenopathy, cough, gait disturbance, vaginal bleeding, hyperhidrosis was reported as recovering. The patient has not been tested for COIVD-19 after the vaccination. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/11/2021,1.0,SEN,,,Medical History/Concurrent Conditions: Sulfonamide allergy; Surgery (I do have pins from prior surgery in both feet.),,,"['Arthralgia', 'Body temperature', 'Cough', 'Dyspnoea', 'Feeling cold', 'Gait disturbance', 'Headache', 'Hyperhidrosis', 'Lymphadenopathy', 'Nausea', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Respiratory rate increased', 'Shock symptom', 'Tremor', 'Urticaria', 'Vaginal haemorrhage']",2,PFIZER\BIONTECH, 1065133,IL,67.0,F,"Bell's Palsy; This is a spontaneous report from a contactable Consumer. This 66-year-old female consumer reported that received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot# not provided), via an unspecified route of administration on 12Feb2021 (at the age of 67-year-old) at 05:45 PM in the left arm at single dose for COVID-19 immunization. She had received the first dose of BNT162B2 on 22Jan2021, at 06:00 PM in the left arm. The patient had no history of allergies to medications, food, or other products. Medical history included Thyroid, Panic Disorder, Mild Depression. Concomitant medications included levothyroxine, simvastatin, trazodone, clonazepam. The patient reported that early in the day, on 12Feb2021, before receiving her second dose, she began to feel something odd going on with her mouth. She couldn't really identify it, but she felt like something wasn't quite the same. It was very mild, so she brushed it off. She had her second vaccine dose, on 12Feb2021 at 5 pm. By about 7 pm that night, she was rushed to the University Name Emergency room and was diagnosed with Bell's Palsy. She was treated with Prednisone 10MG X3, valACYclovir 1g X3, polyviny. At the time of reporting the patient had not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,PVT,LEVOTHYROXINE; SIMVASTATIN; TRAZODONE; CLONAZEPAM,,Medical History/Concurrent Conditions: Depression; Panic disorder; Thyroid disorder,,,['Facial paralysis'],2,PFIZER\BIONTECH, 1065134,ID,71.0,M,"Patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting; Patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting; Patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting; Patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date unknown), via an unspecified route of administration on 12Feb2021 14:00 at single dose for COVID-19 immunization. The patient's medical history included diabetes mellitus and hypertension. The patient had no known drug allergies. The patient's concomitant medication included metformin. The patient previously took first dose of BNT162B2 on 23Jan2021 in the right arm at 07:00 PM. The patient had no COVID prior to vaccination and no COVID tested post vaccination. The patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting on 14Feb2021 23:30. Patient was taken by POV to emergency department where he received fluids and anti-emetic. The outcome of the events were recovered on an unspecified date. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/14/2021,2.0,PVT,METFORMIN,,Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension,,,"['Nausea', 'Neuralgia', 'Syncope', 'Vomiting']",2,PFIZER\BIONTECH, 1065135,MO,90.0,F,"Vertigo and throwing up; Vertigo and throwing up; This is a spontaneous report from a contactable consumer reported for herself. A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot number: EK9231 on 23Jan2021 (at the 90-year-old), at single dose for COVID-19 immunization via unspecified route of administration at the left arm. Medical history included vertigo seven years ago and she had taken a Meclizine for it. The patient wore hearing aids On the day of first COVID-19 Vaccine she was perfectly healthy. She was very alert for a 90-year-old. The patient had received influenza vaccine on unknown date. On 11Feb2021 the patient experienced Vertigo and throwing up. The patient was hospitalized for the events from 11Feb2021 to 13Feb2021. The patient received Meclizine, but it wasn't helping. The patient was admitted for 3 days until she felt well enough. The hospital took a blood test with unknown result. The patient did a little bit of physical therapy and she was given mostly IV fluids because she was throwing up. The outcome of the events was unknown.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/23/2021,02/11/2021,19.0,PVT,,,Medical History/Concurrent Conditions: Hearing aid user; Vertigo (seven years old),,,"['Blood test', 'Vertigo', 'Vomiting']",1,PFIZER\BIONTECH, 1065136,NY,,U,"strokes; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is 1st of 2 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization in a hospital. The patient's medical history reported as none. Concomitant medications were not reported. The physician reported that there were two patients who came in with strokes with no underlying condition/health risks, but they had been recently vaccinated with the COVID vaccine on unspecified date. The event resulted in physician office visit. Outcome of the event was unknown. The event was assessed as serious (hospitalization). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the implied time association, the possible contribution of suspect vaccine BNT162B2 to the event stroke cannot be excluded. The patient's age and detailed clinical course would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021163468 same reporter, product, event; different patient",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['Cerebrovascular accident'],UNK,PFIZER\BIONTECH, 1065137,NY,,U,"strokes; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is 2nd of 2 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization in a hospital. The patient's medical history was reported as none. Concomitant medications were not reported. The physician reported that there were two patients who came in with strokes with no underlying condition/health risks, but they had been recently vaccinated with the COVID vaccine on unspecified date. The outcome of the event was unknown. The event resulted in physician office visit. The event was assessed as serious (hospitalization). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The information is limited and does not allow a full medical assessment. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of stroke, cannot be fully excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021163467 same reporter, product, event; different patient",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Cerebrovascular accident'],UNK,PFIZER\BIONTECH, 1065138,,,F,"hard of hearing; rash; faint; being hot; short of breath; headache; was achy; extremely tired/extremely exhausted; This is a spontaneous report from a contactable nurse (reporting for mother). An 89-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 11Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The first dose of BNT162B2 as COVID-19 immunization was received on an unknown date. Reporter was calling regarding side effects of the Pfizer COVID vaccine. Reporter stated that her mother (patient) is 89 years old and her mother was hard of hearing since an unknown date. Her mother got the second dose of the product 11Feb2021 and she was fine that Thursday, and by Friday (12Feb2021) her mother had a headache, was achy, and extremely tired. On Saturday, her mother felt a little bit better. On Sunday (14Feb2021), her mother had an episode of being hot and faint, and short of breath and extremely exhausted. This morning (15Feb2021), her mother was experiencing shortness of breath, and a rash and was exhausted. Reporter wa wondering if shortness of breath could be a side effect of the product. The outcome of the events headache, achy, and ""extremely tired/extremely exhausted"" was recovering, while for events hard of hearing, being hot, faint, short of breath and rash was unknown. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/12/2021,1.0,UNK,,,,,,"['Dyspnoea', 'Fatigue', 'Feeling hot', 'Headache', 'Hypoacusis', 'Pain', 'Rash', 'Syncope']",2,PFIZER\BIONTECH, 1065139,PA,39.0,F,"breast infection; left breast pain/breast became sore; breast became red, sore, warm and had a line traveling to my armpits; breast became red, sore, warm and had a line traveling to my armpits; breast became sore, warm and had a line traveling to my armpits; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received second single dose (BNT162B2, Pfizer, Solution for injection, lot number: EL3249, exp date not reported), via an unspecified route of administration (vaccine location: left arm) on 19Jan2021 06:00 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient medical history was not reported. There were no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. There were no other medications received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 (Pfizer, lot number: EL1284) on 30Dec2020 06:00 (vaccine location: left arm). On 24Jan2021, the patient started to have left breast pain. Her breast became red, sore, warm and had a line traveling to the armpit. The doctor stated the red area felt full. The patient was treated for a breast infection. Treatment received for the adverse events included: Clindomycin. The events were considered non-serious by the reporter. The events resulted to doctor or other healthcare professional office/clinic visit. Since the vaccination, has the patient had not been tested for COVID-19. The events recovered on an unspecified date in 2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2and the event mastitis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/24/2021,5.0,PVT,,,,,,"['Breast pain', 'Erythema', 'Feeling hot', 'Mastitis', 'Pain']",2,PFIZER\BIONTECH, 1065140,,,F,"went into shock after she got it; This is a spontaneous report from a contactable consumer (daughter's friend) A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on unknown date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that ""a friend of her daughter's went into shock after she got it"" on an unspecified date with outcome of unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Anaphylactic shock'],1,PFIZER\BIONTECH, 1065142,MA,29.0,M,"syncope; pleurisy; difficulty breathing; Flu-like symptoms; fever; chills; muscle and joint aches; muscle and joint aches; persistent headache; This is a spontaneous report from a contactable health care professional (patient). A 29-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK4176) in the hospital, via intramuscular route on 10Feb2021 at 10:30 at a single dose on the right arm for COVID-19 immunization. Medical history included Non-Hodgkin's lymphoma from 2010 to 2011 and allergies to penicillin on an unknown date and unknown if ongoing. Prior to vaccination, was the patient not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient received the first dose of BNT162B2 (lot number: H9899) in the hospital, via intramuscular route at 01:15 PM on the left arm for COVID-19 immunization. Since the vaccination the patient has not been tested for COVID-19. It was reported that on 12Feb2021 at 08:00 PM (also reported as '3 days after injection') the patient experienced flu-like symptoms that included fever, chills, muscle and joint aches, and a persistent headache. On 13Feb2021 (also reported as 'on the 4th day', the patient developed pleurisy and difficulty breathing and had 2 syncope events the morning of 14Feb2021 (also reported as 'on the 5th day'). The patient was taken by ambulance and admitted to ER for further testing. It was determined that all symptoms likely related to the second dose of the COVID-19 vaccine recently received. Pleurisy persists one week following vaccine dose. The patient went to the emergency room/department or urgent care due to the events. As treatment for the event, the patient was monitored and given IV fluids over 12 hour stay in CDU. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects). The events were reported as non-serious.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship and current known drug safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/10/2021,02/12/2021,2.0,PVT,,,Medical History/Concurrent Conditions: Non-Hodgkin's lymphoma; Penicillin allergy,,,"['Arthralgia', 'Chills', 'Dyspnoea', 'Headache', 'Influenza like illness', 'Myalgia', 'Pleurisy', 'Pyrexia', 'Syncope']",2,PFIZER\BIONTECH,OT 1065143,MI,,M,"may have gotten a double dose/ gave him shots in both arms/ thought they inadvertently gave him two doses of it/ unsure if he received two doses or if he only got one; both arms were sore; This is a spontaneous report from a contactable consumer (reported for himself). A male patient of an unspecified age (Age: 73; Unit: Unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: en6200), via an unspecified route of administration on 17Feb2021 at single dose in arm for COVID-19 immunization. Medical history included Heart stents. The patient's concomitant medications were not reported. The patient previously took flu shot for immunization and experienced arms were sore. The patient reported that he may have gotten a double dose today (17Feb2021). They gave him shots in both arms, but said the first shot did not have any thing in it so they gave him another shot. He asked if a double dose was bad they said don't worry about it. Both arms were sore but not any worse than the flu shot. The consumer further reported that he got his first shot today and he thought they inadvertently gave him two doses of it. He got two shots, one in each arm and he was wondering if that's a bad thing. Caller stated they stuck him in one arm and she said ""oh there was nothing in it, I'm going to give you another shot in another arm."" Caller stated that he was unsure if he received two doses or if he only got one. Caller stated that the vaccination card he was provided only had one lot number and expiration date. Caller stated he was pretty sure he felt stuff go in each arm and both arms were sore, but its no more soreness than the flu shot. Caller asked if he was in danger and if he should watch out for side effects. No Covid prior vaccination. No Covid tested post vaccination. The event was non-serious per the reporter. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/17/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Coronary arterial stent insertion,,,"['Overdose', 'Pain in extremity']",1,PFIZER\BIONTECH, 1065144,TN,,M,"kidney infection; This is a spontaneous report from a Pfizer-sponsored program, Support. A contactable male consumer (patient) of unspecified age received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Feb2021, for COVID-19 immunisation. The patient received the first dose of BNT162B2 vaccine on an unspecified date. Medical history and concomitant medications was not reported. On an unspecified date in Feb2021, after the second vaccination, the patient experienced kidney infection. His doctor prescribed antibiotics on 15Feb2021. The patient wanted to know if that will affect the efficacy of the vaccine. Event outcome was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/01/2021,,UNK,,,,,,['Kidney infection'],2,PFIZER\BIONTECH, 1065145,TN,,F,"Friday 12th Feb was tested positive; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support, received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had her 1st dose of the vaccine on the 8th of Feb (2021), and Friday 12th Feb (2021) was tested positive. The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/12/2021,4.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1065146,MN,,F,"Gastrointestinal? Bleeding; This is a spontaneous report from a contactable consumer (Patient's sister) via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # UNKNOWN:), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the first dose already and then had a GI (gastrointestinal) bleeding. The clinical outcome of gastrointestinal bleeding was unknown. Information about lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Gastrointestinal haemorrhage'],1,PFIZER\BIONTECH, 1065147,FL,,M,"tested positive on the 11th; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 03Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received his first COVID shot last 03Feb2021. He tested negative on 10Feb2021 and tested positive on 11Feb2021 and 12Feb2021 for rapid test and lab test. On 14Feb2021, he had monoclonal antibody infusion. The patient wanted to know if he still needed to go to his second vaccine shot appointment that was scheduled on 24Feb2021. The outcome of the event was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/11/2021,8.0,UNK,,,,,,"['COVID-19', 'Investigation', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1065148,AZ,74.0,F,"Altered State of Consciousness.; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on 16Feb2021 16:30 at single dose on left arm for Covid-19 immunisation. Medical history included breast cancer with chemo in 2004. No known allergies. The patient did not have Covid prior vaccination. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN). The patient did not have other vaccine in four weeks.The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283) via an unspecified route of administration on Jan2021 07:00 AM on left arm for Covid-19 immunisation. The patient experienced altered state of consciousness on 17Feb2021 at 07:00. The patient felt like she was standing beside herself, removed from herself. Lightheaded and remote from her thinking or what she was saying. As if on a psychedelic drug. No flu like symptoms at all. No treatment was received for the event. The outcome of the event altered state of consciousness was recovered in Feb2021. The patient did not have covid tested post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PVT,LEVOTHYROXIN,,Medical History/Concurrent Conditions: Breast cancer (breast cancer with chemo in 2004),,,['Altered state of consciousness'],2,PFIZER\BIONTECH, 1065149,,,F,"spure of neuropathy; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Feb2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously, on an unspecified date, the patient took the first dose of the vaccine for COVID-19 immunization. On 12Feb2021 the patient experienced spure of neuropathy. Patient wanted to know if she can take prescribed ""Metanx"", that was prescribed before vaccine but not really taking this medication. The final outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/12/2021,4.0,UNK,,,,,,['Neuropathy peripheral'],2,PFIZER\BIONTECH, 1065150,GA,,M,"Had kidney stones before/Developed kidney stone; Had kidney stones before/Developed kidney stone; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history included kidney stones. Concomitant medications were not reported. The patient developed kidney stones. She had kidney stones before. Outcome of the event was unknown. Information on batch/lot number was requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Kidney stones,,,"['Disease recurrence', 'Nephrolithiasis']",1,PFIZER\BIONTECH, 1065151,MT,82.0,F,"started acting strange, paranoid; started acting strange, paranoid; she forgets things; dementia; This is a spontaneous report from a contactable consumer (patient's daughter) An 82-year-old female patient received the 1st dose bnt162b2 (BNT162B2) at single dose in arm on 22Jan2021 for Covid-19 immunisation, administered a Clinic. Medical history included macular degeneration from Aug2020 and treated with Saffron and Eylea. The concomitant medications included: Saffron, an herb, started a few weeks before the vaccine was administered for macular degeneration, Eylea shot for the macular degeneration and she got a shot within a few weeks of getting one of the vaccines but this is not a new medication for her. No additional vaccines administered on same date of BNT162B2. No prior vaccinations within 4 weeks. The patient experienced dementia in Jan2021, started acting strange, paranoid on 24Jan2021, she forgets things in Jan2021. The events did not require a visit to Emergency Room or Physician Office. Course of events: About 2 days after the 1st shot she started acting strange, paranoid. Her mom lives with her daughter, son in law, and 21-year-old grandson. She though they were stealing from her, her daughter and grandson. Reporter explained she knew this sounded like classic dementia and she forgot things like everyone does but this was uncharacteristic and she was fine up until 3 days after the shot. They have called her primary care doctor who has done blood test looking for a UTI or infection and that came back good. The doctor also did a CT scan and it came back good. Caller explains that the event was about the same since it started. The outcome of dementia was unknown, of started acting strange, paranoid was not recovered. The patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose in arm on 12Feb2021 for Covid-19 immunisation, administered a Clinic. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/01/2021,,OTH,SAFFRON; EYLEA,,Medical History/Concurrent Conditions: Macular degeneration (treated with Saffron and Eylea),,,"['Amnesia', 'Blood test', 'Computerised tomogram', 'Dementia', 'Feeling abnormal', 'Paranoid personality disorder']",1,PFIZER\BIONTECH, 1065152,NY,,U,"had a bout of strep throat; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unspecified date in Jan2021 (3 weeks before this report) for Covid-19 immunisation, administered at a clinic as staff member. The patient medical history and concomitant medications were not reported. The patient experienced a bout of strep throat (mild) on an unspecified date after receiving the 1st dose and took an antibiotic in the past 24 hours. The outcome of events was unknown. The documentation stated still to give the vaccine. Information on batch/lot number was requested.; Sender's Comments: Based on the available information, the event ""a bout of strep throat"" is attributed to an intercurrent medical condition that was unrelated to BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,,,OTH,,,,,,['Streptobacillus infection'],1,PFIZER\BIONTECH, 1065153,AL,71.0,M,"Heart arrhythmia; This is a spontaneous report from a contactable Other Health Professional. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK9231), intramuscularly in Right arm on 26Jan2021 01:00 at single dose for COVID-19 immunisation. Medical history included HTN (hypertension), BPH (benign prostatic hyperplasia). Concomitant medication in two weeks included lisinopril, tamsulosin hydrochloride (TAMULOSIN), ergocalciferol (VIT D). Facility type vaccine: Public Health Clinic/Veterans Administration facility. If other vaccine in four weeks: No. The patient previously took naproxen and experienced allergies: Naproxen. If Covid prior vaccination: No. If Covid tested post vaccination: No. The patient experienced heart arrhythmia (medically significant) on 29Jan2021 12:00 with outcome of not recovered. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Holter monitor.; Sender's Comments: Based on the temporal gap between the vaccination and the event onset, the event heart arrhythmia is considered as unrelated to suspect vaccine BNT162B2. The patient is most likely due to underlying cardiovascular conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/29/2021,3.0,PUB,LISINOPRIL; TAMULOSIN; VIT D,,Medical History/Concurrent Conditions: Hypertension; Prostatic hyperplasia,,,['Arrhythmia'],1,PFIZER\BIONTECH,OT 1065154,ND,89.0,F,"Shrunk a little bit; really hot; Shivering; Tiredness; Fever; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in the left arm on 04Feb2021 at 89-year-old at a single dose for COVID-19 immunization. Medical history included macular degeneration from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249; left arm) for COVID-19 immunization on an unknown date. The patient experienced the following events and outcomes: shivering (non-serious) on 10Feb2021 with outcome of recovered on 11Feb2021, tiredness (non-serious) on 10Feb2021 with outcome of not recovered, fever (non-serious) on 10Feb2021 with outcome of recovered on 11Feb2021, shrunk a little bit (non-serious) on an unspecified date with outcome of unknown, really hot (non-serious) on 10Feb2021 with outcome of recovered on 11Feb2021. The patient underwent lab tests and procedures which included body temperature: highest her temperature got was 100 on an unspecified date. About six days after the patient had her second COVID shot, the patient experienced shivering and tiredness. It was reported that the patient had shrunk a little bit starting on an unspecified date. At the time of the report, over the last 3 days, the patient experienced the side effects. ""It could be from something else. She could have gotten something. She did not know."" The patient also had a fever a few times. The patient would go between shivering and really hot so she would take her temperature. The patient did not normally have a fever. When the shivering came on, she was trying to cook, and could not hold the spoon in her hand. The patient did not know what was wrong, but she was cold. All she wanted to do was sleep. The only symptom she still had was being tired. The night before the report, the patient woke up so warm and was sweating; her pajamas were damp. The patient could not sleep in them, so she had to go change. The patient has not shivered since then. The tiredness was persisting. The patient slept on and off all day today, but she was feeling better in general. The patient took her temperature every day. ""The highest her temperature got was 100.""",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/10/2021,6.0,UNK,,,Medical History/Concurrent Conditions: Macular degeneration,,,"['Body height decreased', 'Body temperature', 'Chills', 'Fatigue', 'Feeling hot', 'Pyrexia']",2,PFIZER\BIONTECH, 1065155,IL,60.0,F,"Heart attack; Myocarditis; Chills; didn't check her temperature but is sure she had one/She didn't check her temperature but she is sure she had a fever; was soaking wet when she woke up like her fever had broken and then she was fine/She woke up and was very sweaty; achy right side; Headache; This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration in the right arm, on 06Jan2021 at 18:00 at the age of 60 years, at a single dose for Covid Prevention/COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of Covid-19 vaccine (Manufacturer: Pfizer, with Lot Number: EK5730) in the right arm, on 18Dec2020 at the age of 60 years for COVID-19 immunization. The patient reported that 13 days after the last dose of the vaccine, on 19Jan2021, she had a heart attack. She has no heart issues whatsoever. She had diagnostic testing such as a cardiac catherization, echocardiogram, both on 19Jan2021; and a heart MRI with contrast on 20Jan2021. The test results indicated that she had myocarditis caused by a virus. The cardiac catherization and echocardiogram also revealed heart attack because of myocarditis. She did not have any other issues with her heart. The patient asked if they would they let her know if anything comes up as far as information. The patient has recovered with lasting effects. She would be on medication for the next 3 years supposedly. The heart attack was caused by myocarditis which was caused by a virus. There were no other issues with her heart, arteries or anything. These events required a visit to the emergency room. She first went to a hospital in the city and was transferred via ambulance to another hospital in another city on the same day. Patient was hospitalized for the heart attack and myocarditis from 19Jan2021 to 22Jan2021. She had a lot of other symptoms the next day after receiving the vaccine on 07Jan2021. She also experienced chills. She didn't take her temperature but is sure she had one. She was achy on her whole right side and she had a headache. She started having chills at 1:30 PM (13:30) while at an eye doctors appointment. She laid down and was soaking wet when she woke up like her fever had broken and then she was fine. She didn't check her temperature but she is sure she had a fever. She woke up and was very sweaty. The outcome of the events heart attack and myocarditis was recovered with sequelae on Jan2021. The outcome of the remaining events was recovered on 07Jan2021.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,,,,,,"['Body temperature', 'Catheterisation cardiac', 'Chills', 'Echocardiogram', 'Headache', 'Hyperhidrosis', 'Magnetic resonance imaging', 'Myocardial infarction', 'Myocarditis', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1065156,GA,78.0,M,"Kidney stones; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Batch/Lot number: EL3247), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included nephrolithiasis (before getting the COVID shot). The patient's concomitant medications were not reported. The patient experienced kidney stones on an unspecified date. The patient explained that he was scheduled for the second COVID shot on Wednesday. He noted that he has developed a kidney stone and wanted to know if it was ok to get the second dose. It was confirmed that he was used to the pain and has had a bunch of them in the past; he has a history of kidney stones before getting the COVID shot. He stated that he wanted to go ahead and get the shot, the appointments were so hard to get. Outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Kidney stones (before getting the COVID shot.),,,['Nephrolithiasis'],UNK,PFIZER\BIONTECH, 1065157,,,F,"overly dehydrated; high blood pressure/ blood pressure was 178/122; could not sleep entirely/she was in a semi-sleep state/having insomnia feeling like really bad; could not move or open her eyes; her head felt like exploding; her heart pounding/ heart rate 102; extreme fatigue; This is a spontaneous report from a contactable consumer (the patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 12Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization, and experienced: arm soreness, nausea, and headache, on an unspecified date. After 1 hour 30 minutes of getting the second dose on 12Feb2021, the patient felt an extreme fatigue and went to sleep. She could not sleep entirely (from an unspecified date) and woke up and went to the bathroom several times after midnight and she tried to wake up at 4 am, but she was in a semi-sleep state half aware and could not move or open her eyes no matter how hard she tried. She described this state as she couldn't move and having insomnia feeling like really bad. When she managed to pull this up, she took her pulse and blood pressure and she was having high blood pressure, her head felt like exploding and also her heart pounding. Her blood pressure was 178/122 and her heart rate 102. She stated that her husband tried to call Pfizer that moment, but they could not get a hold of someone after 30 minutes, so they contacted 911. She was taken to the hospital, and her chest X-ray and EKG were normal (to discard a heart attack). Then they noted that she was overly dehydrated, so they prepared some IV (intravenous) solution for her. The clinical outcome of the events was unknown. Information on Lot /Batch Number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/12/2021,02/12/2021,0.0,UNK,,,,,,"['Blood pressure measurement', 'Chest X-ray', 'Dehydration', 'Electrocardiogram', 'Fatigue', 'Head discomfort', 'Heart rate', 'Hypertension', 'Hypokinesia', 'Insomnia', 'Palpitations']",2,PFIZER\BIONTECH, 1065158,FL,,M,"death; severe headache; This is a spontaneous report from a non-contactable consumer from a Pfizer-sponsored program. A male patient of an unspecified age (Age: 83, unit: Unknown; as reported) received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:EH9899), intramuscularly in the left arm on 20Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history included sulfonamide allergy from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously took azithromycin [MANUFACTURER UNKNOWN] and experienced allergy on an unspecified date. On 22Jan2021, the patient experienced severe headache (non-serious). On 28Jan2021, the patient experienced death (death, medically significant); 8 days after receiving the vaccine. The patient died on 28Jan2021 due to unknown cause of death. It was unknown if an autopsy was performed. The clinical outcome of the event, death, was fatal. The clinical outcome of the event, severe headache, was not recovered. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Unknown cause of death",Yes,01/28/2021,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/22/2021,2.0,UNK,,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,"['Death', 'Headache']",1,PFIZER\BIONTECH,OT 1065159,MT,75.0,F,"Transverse myelitis; bowel and urine issues; bowel and urine issues; she can't walk; numbness from her toes up to her breast on the left side and numbness from her toes to her groin on the right side; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 at 13:00 at single dose into right arm for COVID-19 immunisation at the age of 75-year-old. Lot number was EL8982. Medical history was unknown and concomitant medications included blood pressure pills and cholesterol pills and vitamins. On 24Jan2021, the patient experienced transverse myelitis; the patient was hospitalized due to the event (hospitalization dates from 24Jan2021 to 7Feb2021; emergency room since 24Jan20211 noon). Consumer stated that when she was in the hospital, she was on heavy doses of steroids intravenous (IV) for 5 days. Blood work at the hospital was normal. Consumer left the hospital to go to the rehab facility on 30Jan2021, and then consumer left the rehab facility on 07Feb2021. Consumer stated that she could not walk. Consumer had complete numbness from her toes up to her breast on the left side and numbness from her toes to her groin on the right side. Consumer stated that she was still having issues with dragging her left leg, and with rehab, she was finally getting back some feeling, the numbness was still there but she was having bowel and urine issues. Consumer stated that her issues have somewhat improved with the help of rehab. The patient was recovering from the events.",Not Reported,,Not Reported,Yes,14.0,Not Reported,N,01/23/2021,01/24/2021,1.0,UNK,,,,,,"['Abdominal discomfort', 'Blood test', 'Gait disturbance', 'Hypoaesthesia', 'Myelitis transverse', 'Urinary incontinence']",1,PFIZER\BIONTECH, 1065160,TN,,F,"Stroke; This is a spontaneous report from a contactable consumer reporting on behalf of the mother. An approximately 81-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021, for COVID-19 immunisation. The patient received the first dose of BNT162B2 vaccine on 23Jan2021 (Batch/lot number: EL3302). Medical history was not reported. Concomitant medications included two unspecified prescriptions. On 13Feb2021 the patient experienced stroke which required hospitalization on the same day. The reporter was not sure of the name but they did a 'CAT' where they went up and pull the clot out of the brain. Event outcome was unknown. The patient was still in the hospital at the time of report. No investigation was performed before the event.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/10/2021,02/13/2021,3.0,UNK,,,,,,['Cerebrovascular accident'],2,PFIZER\BIONTECH, 1065161,OH,29.0,F,"My mouth and tongue started itching; Skin broke out in a rash and became super itchy; Skin broke out in a rash and became super itchy; Have hives; This is a spontaneous report from a consumer reporting for herself. A 29-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # em9809) vaccine , via an unspecified route of administration in the left arm on 24Feb2021 14:30 at single dose for covid-19 immunisation . Medical history included asthma , attention deficit hyperactivity disorder , polycystic ovaries , sleep apnoea syndrome, arthralgia , the patient was allergic to Albuterol, Penicillin, Cephalosporin, Iodine, Bees, all types of fish, all types of shellfish, peanuts, all types of tree nuts. Concomitant medication included cefixime (FLEXERIL), acetylcarnitine hydrochloride (NEUROTIN ), naproxen (MOTRIN). The patient experienced my mouth and tongue started itching on 24Feb2021 14:30 with outcome of not recovered , skin broke out in a rash and became super itchy on 24Feb2021 14:30 with outcome of not recovered , have hives on 24Feb2021 14:30 with outcome of not recovered. The reported events were considered Life Threatening. The patient received Benadryl, and got epi on hand as treatment. Follow up information has been requested.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/24/2021,02/24/2021,0.0,PHM,FLEXERIL [CEFIXIME]; NEUROTIN [ACETYLCARNITINE HYDROCHLORIDE]; MOTRIN [NAPROXEN],,Medical History/Concurrent Conditions: ADHD; Allergy to nuts; Asthma; Fish allergy; Insect bite allergy; Iodine allergy; Obstructive sleep apnea syndrome; Pain in hip; Peanut allergy; Penicillin allergy; Polycystic ovarian syndrome,,,"['Oral pruritus', 'Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH, 1065162,OH,,M,"pneumonia; This is a spontaneous report from a contactable consumer reported for a patient (Husband) via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of bnt162b2, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date which required hospitalization until now. The outcome of event was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,,,,UNK,,,,,,['Pneumonia'],1,PFIZER\BIONTECH, 1065163,,,F,"Little lip swollen that looks like a classic symptom of little angioedema on her left side; Little lip swollen that looks like a classic symptom of little angioedema on her left side; This is a spontaneous report from contactable consumer. This consumer reported for a female patient (mother in law) of an unspecified age that received first dose of bnt162b2 (BNT162B2, lot number: EN6201) , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced little lip swollen that looks like a classic symptom of little angioedema on her left side on an unspecified date with outcome of unknown. Reporter stated, ""It is for my mother in law. Looks like she has a little angioedema on her lip. She did have the second shot today, Pfizer, 2nd shot (Unspecified Medication). It is not severe but she does have a little lip swollen that looks like a classic symptom of little angioedema on her left side. She had the shot on her right side. I just was not sure, I mean should she take Benadryl."" Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Angioedema', 'Lip swelling']",1,PFIZER\BIONTECH, 1065164,VA,74.0,F,"sweating; Chills; AFIB; Heart rate racing; Lightheadedness and dizzy and felt like she would pass out.; Nausea; Muscle ache; Headache; Second dose arm hurt at injection site; compromised immune status; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), intramuscular at arm left on 13Feb2021 at 10:30 (at the age of 74 years) at single dose for COVID-19 immunization. Medical history included primary biliary cholangitis (PBC, autoimmune condition and was diagnosed 10 years ago), diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, diabetes and obesity, all from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular at arm left on 24Jan2021 and experienced sore arm. The patient experienced headache and arm hurt at injection site, both on 13Feb2021 at 19:00; heart rate racing, AFib, lightheadedness and dizzy and felt like she would pass out, all on 14Feb2021 at 07:30; nausea, muscle ache, both on 14Feb2021 at 03:00, chills on 14Feb2021 at 15:00 and sweating on 14Feb2021 at 16:00. The patient outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/13/2021,0.0,OTH,,,Medical History/Concurrent Conditions: Allergy; Cytogenetic abnormality; Diabetes; Immune system disorder; Obesity; Primary biliary cholangitis (PBC is her autoimmune condition and was diagnosed 10 years ago.); Respiratory disorder,,,"['Atrial fibrillation', 'Chills', 'Dizziness', 'Headache', 'Heart rate', 'Hyperhidrosis', 'Myalgia', 'Nausea', 'Palpitations', 'Product use issue', 'Vaccination site pain']",2,PFIZER\BIONTECH,OT 1065327,SD,57.0,F,Developed acute respiratory distress with bilateral pulmonary infiltrates. Suspicious for pulmonary edema. CXR clear 2/6/21.,Not Reported,,Yes,Yes,1.0,Not Reported,N,02/23/2021,03/02/2021,7.0,UNK,Outpatient Medications senna-docusate sodium (SENOKOT-S;PERICOLACE) 8.6-50 MG tablet Take 1 tablet by mouth 2 times a day ondansetron (ZOFRAN) 8 MG tablet Take 1 tablet (8 mg) by mouth 3 times a day as needed for nausea or vomiting cloNI,Constipation with stercoral ulcer with recent completion of Augmentin.,"ESRD due to IgA nephropathy, Uncontrolled HTN with LVH, Anemia, Obesity, GERD Prior COVID hospitalization with respiratory failure in April 2020",,Venofer,"['Acute respiratory distress syndrome', 'Chest X-ray normal', 'Electrocardiogram', 'Laboratory test', 'Lung infiltration', 'Pulmonary oedema']",2,PFIZER\BIONTECH,IM 1065341,WA,91.0,F,Systemic: Made aware of patient passing away on 3/1 per letter from Corporate legal team. Patient passed away on 2/14. Vaccine 1st dose given 1/29/21.-Severe,Yes,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/11/2021,13.0,SEN,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1065379,,,F,"Cardiac tamponade; very weak; A spontaneous report was received from a consumer concerning a female patient of unknown age who, experienced cardiac tamponade, and very weak. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 21JAN2021, approximately 4days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:039L20A) intramuscularly for prophylaxis of COVID-19 infection. Caregiver-patient's daughter called to report that her mother potentially experienced an adverse reaction to the vaccine. Patient received the first dose of the vaccine on 21JAN2021, and 4 days later the patient developed cardiac tamponade and was very week. Patient went to the doctor's office where they were directed to wait for the second dose of the vaccine. Caller/caregiver wants to know how long they can wait for the second dose of the vaccine. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the events was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/25/2021,4.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Asthenia', 'Cardiac tamponade']",1,MODERNA,OT 1065380,NY,82.0,M,"Passed Out; Felt really bad and weak; Achy in his shoulders and neck; Chills; Temperature started at 99.6 then 100-101F; Burn really bad when he urinated; Traces of blood in urine; Threw up really bad; Fatigue; Joint Pain; Nausea; A spontaneous report received from a Consumer concerning, 82-year-old male patient who received first dose of the Moderna COVID-19 vaccine and experienced a lot of incidences. /MedDRA PT: [Incidences] The patient's medical history included Type 2 Diabetic. Patient's concomitant included Metformin 500mg daily. On 13FEB2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in right arm (Batch #: 011M20A) intramuscularly for prophylaxis of COVID-19 infection. Patient friend stated he got the Moderna vaccine on 13FEB2021 at 2:30pm in the right arm. He urinated fine at church the next day on 14FEB2021. At 2:30pm, Patient friend stated he started feeling bad and weak and could barely unlace his shoes. Patient friend stated that he had achy in his shoulders and neck, and chills. Patient friend stated he is a type 2 diabetic and he thought his blood sugar was very high and took a 500mg metformin (usually takes it once a day). Patient checked blood sugar which was 99 (low for him). Patient friend stated that she gave him apple juice to bring it back to normal. Patient friend stated his temperature started at 99.6F and an hour later it was 100-101F. Patient was told by HCP to take Tylenol. Patient friend stated that he had burning and traces of blood in his urine. Patient friend stated that the second time he urinated; it was less burning. Patient friend stated that he had severe vomiting and passed out. Patient went to bed at 7PM and then at 8:45PM, without the Tylenol, temperature went back to 99.6F. Patient friend stated that he feels completely fine now. Patient friend stated that she only gave him only two 500mg Tylenols for the whole 24 hours of the reactions. Patient friend stated that he had other symptoms including fatigue, muscle pain, joint pain, chills, nausea, vomiting, and fever but no headache. Patient friend would like to know if the Moderna COVID-19 do something to his kidney or bladder? Patient friend would like to know if he should get the second Moderna COVID-19 vaccine. However, the patient still would like to get the second vaccine to be protected from COVID-19. Patient was treated with 1 500mg Metformin and 2 500mg Tylenols. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was unknown/not reported.; Reporter's Comments: This case concerns an 82-year-old male who experienced a serious unexpected event of Loss of consciousness along with NS unexpected feeling abnormal, dysuria, blood in urine, and NS expected fever, chills, myalgia, arthralgia, nausea, vomiting, fatigue. Event onset 1 day after the first dose of mRNA-1273. Treated with Tylenol. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/14/2021,1.0,UNK,METFORMIN,Diabetic,,,,"['Arthralgia', 'Blood glucose', 'Blood urine present', 'Chills', 'Dysuria', 'Fatigue', 'Feeling abnormal', 'Loss of consciousness', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,OT 1065381,AZ,66.0,F,"Could not hear anything 2 days post-vaccination; A spontaneous report was received from a consumer who was also a female patient, unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and could not hear anything 2 days post-vaccination. The patient's medical history included Meniere's disease and hearing aids user. No relevant concomitant medications were reported. On 13 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030M20A) for prophylaxis of COVID-19 infection. The patient received her first shot on 13 Feb 2021 and could not hear anything two days post-vaccination. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, could not hear anything 2 days post-vaccination, was considered resolved on 22 Feb 2020.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient's medical history of Meniere's disease and use of hearing aids is a confounder to the causality.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/15/2021,2.0,UNK,,Hearing aid user; Meniere's disease,,,,['Deafness'],1,MODERNA,OT 1065382,NJ,39.0,F,"didn't receive the entire dose; felt the medication on her skin/medication leaked out around the needle during injection; felt the medication on her skin/medication leaked out around the needle during injection; A spontaneous report was received from a healthcare facility staff member concerning a 39 years old, female patient who didn't receive the entire dose of vaccine, felt the medication on patient's skin and medication leaked out around the needle during injection while administration of Moderna's COVID-19 vaccine. The patient's medical history included Augmentin as a child. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: not provided) on an unknown date. On 17-FEB-2021, the patient received their second of two planned doses of mRNA-1273 (Batch number004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The reporter reported that, patient didn't receive the entire dose, felt the medication on her skin and medication leaked out around the needle during injection while administration of vaccine. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events: therefore, action taken with the drug in response to the events is not applicable. The outcome of the events was not reported.; Reporter's Comments: This report refers to a case of accidental underdose and syringe connection issue for mRNA-1273 (Batch number004M20A) associated with the event of exposure via skin.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Drug allergy,,,"['Accidental underdose', 'Device connection issue', 'Exposure via skin contact']",2,MODERNA,OT 1065383,MA,,F,"Instead of a 5cc dose was given a 3 cc dose; A spontaneous report was received from a female nurse who received Moderna COVID-19 vaccine (mRNA-1273) and was administered an incomplete dose. The patient's medical history includes bronchiolitis, asthma and high blood pressure. Concomitant medications included an unspecified inhaler and three different medications for high blood pressure. On 15-FEB-2021, prior to the onset of events, the patient received her first of two planned doses of COVID-19 vaccine intramuscularly in left arm (Lot# 011M209). On that day, instead of 5cc dose, she was given 3cc as the person administering the vaccine was giving Pfizer drug previously. She didn't experience any adverse event following the vaccine administration. No treatment information was provided. Action taken with 2nd dose of vaccine is not reported. The outcome of the event, incomplete dose administered, was considered resolved on 15 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # 011M209 with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,UNK,,Asthma; Bronchiolitis; Hypertension,,,,['Incorrect dose administered'],1,MODERNA,OT 1065384,FL,84.0,F,"received two 2nd doses on same day; A spontaneous report was received from a physician concerning a 84-year old, female patient who received Moderna's COVID-19 vaccine and was administered two second doses on the same day (MedDRA PT: extra dose administered). The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. The patient received their first dose of mRNA-1273 on 20-JAN-2021. On 18-FEB-2021, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 18-FEB-2021, the patient received two doses on the same day. One dose was given at the health department. One dose was given at the reporter's clinic. A total of three doses were given. Treatment information was not provided/unknown. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The outcome of the event, extra dose given was considered recovered/resolved on 18 Feb 2021.; Reporter's Comments: This report refers to a case of extra dose administered for mRNA-1273 with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,02/17/2021,28.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Extra dose administered'],1,MODERNA,OT 1065385,VT,,M,"exposure to skin; invalid dose; exposure to skin; A spontaneous report was received from a healthcare facility staff member concerning male patient who had invalid dose of administration and exposure to skin of Moderna's COVID-19 vaccine. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 18-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number unknown) intramuscularly for prophylaxis of COVID-19 infection. The reporter reported that, the syringe cracked, and the Moderna Covid-19 Vaccine ran down patient's arm. Reporter was not sure about the patient received very much of the dose. Treatment information was not provided. Action taken with second dose of mRNA-1273 in response to the events was not provided. The outcome of the events, were considered as recovered.; Reporter's Comments: This report refers to a case of vaccine underdose, syringe connection issue and exposure via skin for mRNA-1273 (Batch number unknown) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Device connection issue', 'Exposure via skin contact', 'Incorrect dose administered']",1,MODERNA,OT 1065386,VA,45.0,F,"Needle popped out and vaccine landed in her hand; Not sure if received full dose; A spontaneous report was received from a (Consumer) concerning a 45 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced needle popped out and vaccine landed in her hand and not sure she received full dose. The patient's medical history included unspecified surgery. Concomitant product use included duloxetine hydrochloride, zolpidem tartrate, and ketorolac tromethamine. On an unknown date, the patient received their first of two planned doses of mRNA-1273. On 18 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (lot #not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 18 Feb 2021, during administration of injection, the needle popped out and vaccine landed on the patient's hand. The nurse put the needle back on and administered the remaining dose. The patient was not sure if full dose was received. Action taken with mRNA-1273 in response to the events was not applicable as the patient received both doses. The events were resolved on 18 Feb 2021.; Reporter's Comments: This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273 (lot #not provided) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,UNK,CYMBALTA; AMBIEN; TORADOL,,Medical History/Concurrent Conditions: Surgery,,,"['Device connection issue', 'Underdose']",2,MODERNA,OT 1065387,OR,,M,"Under Age only 16 years old; arm pain; A spontaneous report was received from a consumer concerning a 16 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was provided as asthmatic. No relevant concomitant medications were reported. On 18-Jan-2021, prior to the onset of the events, the patient received their first planned dose of mRNA-1273 intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. It was reported that the patient had slight arm pain, which went away in two days on 20-Jan-21. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, ""underage only 16 years old"" was unknown. The outcome of event arm pain was resolved on 20 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old male) for mRNA-1273 (lot number unknown) with reported listed nonserious event of injection site pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/18/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Asthma,,,"['Product administered to patient of inappropriate age', 'Vaccination site pain']",1,MODERNA,OT 1065388,,,M,"worried they didn't get enough of the first dose; the dose came out the side of the syringe; Most of the dose ran down patient's arm; A spontaneous report was received from a pharmacist concerning a 61 year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the dose came out side of the syringe. The patient's medical history was not provided. No relevant concomitant medications were reported. On 16 Feb 2021, the patient received their first planned dose of mRNA-1273 (lot/batch: 031M20A) intramuscularly in the deltoid muscle for prophylaxis of COVID-19 infection. On 16 Feb 2021, the pharmacist was injecting the Moderna vaccine and the dose came out of the syringe. Most of the dose ran down the patient's arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The events outcome was recovered.; Reporter's Comments: This report refers to a case of Product administration error � Underdose ,Device connection issue,Exposure via skin contact for mRNA-1273, lot # 031M20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Device connection issue', 'Exposure via skin contact', 'Underdose']",1,MODERNA,OT 1065389,,17.0,F,"17 year old mistakenly received the first dose of the vaccine; A spontaneous report was received from a nurse concerning a 17 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) The patient's medical history was not provided. No relevant concomitant medications were reported. On 25 Jan 2021, the first dose of vaccine was administered to 17 year old female Action taken with mRNA-1273 in response to the events was not reported. The outcome of event was recovered.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273 with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1065390,CA,,F,"syringe was visibly bent after administration and vaccination fluid ran down arm; syringe was visibly bent after administration and vaccination fluid ran down arm; Exposure via skin; A spontaneous report was received from a pharmacist concerning female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and she stated that the syringe was visibly bent after administration and vaccination fluid ran down arm. No relevant medical history was provided. Concomitant medications were not listed. On 11 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (batch: unknown) for prophylaxis of COVID-19 infection. On 11 Feb 2021,the reporter stated that the syringe was visibly bent after administration and vaccination fluid ran down arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event syringe was visibly bent after administration and vaccination fluid ran down arm was resolved.; Reporter's Comments: This report refers to a case of vaccine underdose, syringe connection issues and exposure via skin for mRNA-1273 (batch: unknown) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/11/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history is provided.),,,"['Device connection issue', 'Exposure via skin contact', 'Underdose']",1,MODERNA,OT 1065391,,17.0,M,"Mistakenly received the first dose of the vaccine; A spontaneous report was received from a nurse concerning a 17 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Product administered to patient of inappropriate age. The patient's medical history was not provided. No relevant concomitant medications were reported. On Date 25-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) at unknown route and anatomical location for prophylaxis of COVID-19 infection. The patient experienced the event medication error- 17 years old individual mistakenly received the first dose of the vaccine. Treatment details if provided or No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event 17 years old individuals mistakenly received the first dose of the vaccine unknown.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273 (lot/batch: unknown) with no associated AEs.; Sender's Comments: MOD-2021-015769:Same reporter",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1065392,,,F,"A large lesion - erythematous, with very large bullae; Feels more painful now than when it contained fluid; It's more like a burn; Felt very tired; Stressed; Cutaneous hypersensitivity; A large lesion - erythematous, with very large bullae; The vaccine went SC or ID instead of IM; A spontaneous report (United States) was received from a concerning female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cutaneous hypersensitivity, large lesion - erythematous, with very large bullae, tiredness, stress, burning sensation, pain, blisters. The patient's medical history was not provided. Concomitant medications were not reported. On 13-Feb-2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. 12 hours post vaccination patient experienced cutaneous hypersensitivity. and large lesion-erythematous, with very large bullae. On 18-Feb-2021, patient experienced burning sensation, pain, blisters, tiredness, stress. No treatment was given. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events were unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced serious unexpected event of Dermatitis allergic along with NS unexpected events of Incorrect route of product administration, skin lesion, blister, pain, skin burning sensation, fatigue and stress. The events occurred the same day as the first dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/13/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Blister', 'Dermatitis allergic', 'Fatigue', 'Incorrect route of product administration', 'Pain', 'Skin burning sensation', 'Skin lesion', 'Stress']",1,MODERNA,OT 1065393,AZ,48.0,F,"Osteonecrosis of the jaw; A spontaneous report was received from a consumer concerning a 48 years-old female patient who received Moderna's Covid 19 vaccine (mRNA1273) and developed osteonecrosis of jaw. The patient's medical history included active breast cancer with bone metastasis. Products known to have been used by the patient, within two weeks prior to the event, included denosumab. The patient received first of two planned dose of mRNA-1273 (Lot # 015M20A) intramuscularly on 10-FEB-2021 for prophylaxis of Covid 19 infection. On an unknown date in Feb 2021, after vaccination, the patient discovered that she had osteonecrosis of the jaw. The patient had bone exposed in the jaw about a week after getting the vaccine. Patient took a bone density drug, Xgeva (denosumab). Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event Osteonecrosis of jaw was unknown.; Reporter's Comments: Based on the current available information, the pathogenesis of osteonecrosis formation and mechanism of action of mRNA-1237 vaccine, the event of osteonecrosis of jaw is assessed as unlikely related. The patient's medical history of active breast cancer with bone metastasis is a contributing factor and confounds causality assessment. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,02/01/2021,,UNK,XGEVA,Bone metastases; Breast cancer (Patient is on treatment .),,,,['Osteonecrosis of jaw'],1,MODERNA,OT 1065394,,,F,"Died; A spontaneous report was received from a consumer on a social media, concerning a 58-years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and died. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the event, the patient received dose of mRNA-1273 (Lot number: unknown), for the prophylaxis of COVID-19 infection. On 17-Feb-2021, social media interaction was posted concerning a death of a patient on an unknown date after receiving Moderna vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on an unknown date. The cause of death was not provided. Plans for autopsy were not provided.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. The cause of death was not provided. Plans for autopsy were not provided.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-018302:Same Reporter; Reported Cause(s) of Death: Unknown cause of death",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Death'],UNK,MODERNA,OT 1065395,TN,19.0,M,"Pain in vaccine shot site; Headaches; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient, who is 19-year-old at the time of vaccination, received first dose of bnt162b2 (BNT162B2), lot number: EL9261, via an unspecified route of administration at Left arm on 28Jan2021 13:30 as SINGLE DOSE for COVID-19 immunization. Medical history included Brain trauma injury. On 28Jan2021 16:00, the patient experienced Pain in vaccine shot site and headaches. The outcome of the events was recovered. Therapeutic measures were taken as a result of the events which includes Tylenol and Motrin. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,PUB,,,Medical History/Concurrent Conditions: Traumatic brain injury,,,"['Headache', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1065396,FL,73.0,F,"Mild nausea; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 28Jan2021 18:30 at single dose (right arm) for covid-19 immunization. Medical history included allergies, asthma and Clostridium difficile (c.dif). Patient had allergies to medications, food or other products. The patient was not pregnant. Concomitant medication included rosuvastatin within 2 weeks of vaccination. The patient received other vaccine within 4 weeks prior to Covid vaccine included 1 dose of pneumonia vaccine on 07Jan2021 at a clinic. On 28Jan2021 18:30, the patient experienced mild nausea. Treatment was not received for the event. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient has not patient been tested for covid-19. Outcome of event was recovered on an unspecified date. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,ROSUVASTATIN,,Medical History/Concurrent Conditions: Allergy; Asthma; Clostridium difficile infection,,,['Nausea'],1,PFIZER\BIONTECH, 1065397,,,U,"antibodies which was negative; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot/batch number and expiry date unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on Dec2020. On an unspecified date in 2021, the patient had his/her antibodies checked which was negative. Patient was concerned that the vaccine was not effective as advertised. The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,,,UNK,,,,,,"['SARS-CoV-2 antibody test', 'SARS-CoV-2 antibody test negative']",2,PFIZER\BIONTECH, 1065398,NC,67.0,M,"experiencing a bit of body aches; a little achy; This is a spontaneous report from a contactable consumer (patient's husband) from the medical information team. A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 28Jan2021 at a single dose (at the age of 67-years-old) for COVID-19 immunization. Medical history included pacemaker/defibrillator and 25% of heart function. Concomitant medications were not reported. The patient received the first dose on 28Jan2021 and was experiencing a bit of body aches (since Jan2021) and was taking paracetamol (TYLENOL), no other symptoms. The consumer had a little concern because the patient has a pacemaker/defibrillator. Before he had the defibrillator, his heart rate was over 300 but now it was normal and the patient was monitored. The patient's doctor recommended everybody to get the vaccine. The consumer had a concern about the second shot because he heard that the dose was stronger than the first dose. The consumer wanted to know if that was true. The consumer wanted to know if the patient would be fine for the second dose. The consumer added that the patient only has 25% of heart function. They have talked to his doctors, his cardiologist about getting the vaccine. All the heart doctors were telling their heart patient to get the vaccine to prevent them from getting COVID. The consumer added that after receiving the first COVID-19 vaccine, the patient was a little achy (Jan2021) like when he has the flu shot (for immunization on an unspecified date.) He was going to get over that. It was not raising his heart rate or anything. The consumer clarified further that the patient was just achy but has done really well. The patient slept good last night. He has a heart monitor in the bedroom and had no problems. The consumer wanted to understand if the second shot was thicker than the first shot and what was the difference between the first and second vaccine. The patient has not recovered from the events. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Defibrillator/pacemaker insertion; Heart disorder,,,"['Heart rate', 'Myalgia', 'Pain']",1,PFIZER\BIONTECH, 1065399,WA,43.0,F,"A blister was noted 2 days after injection that was bigger than a pea but smaller than a dime.; The injection appeared to be low than deltoid and concern it was subcutaneous rather than IM; This is a spontaneous report from a contactable pharmacist. A 43-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiration date: unknown), via subcutaneous route on her right deltoid from 25Jan2021 10:15 to 25Jan2021 10:15 at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 04Jan2021 at 10:15 via intramuscular route on her right arm. On 27Jan2021 at 22:00, a blister was noted 2 days after injection that was bigger than a pea but smaller than a dime. The injection appeared to be low than deltoid and concern it was subcutaneous rather than intramuscular (IM). The outcome of the event was recovered on an unspecified date. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,PVT,,,,,,"['Blister', 'Incorrect route of product administration']",2,PFIZER\BIONTECH,OT 1065400,,,F,"swelling in the wrist, hand, fingers; swelling in the wrist, hand, fingers; muscle soreness in the left arm and difficulty in the lifting; muscle soreness in the left arm and difficulty in the lifting; soreness in shoulder, upper left quadrant, back, neck; soreness in shoulder, upper left quadrant, back, neck; achy injection site/throbbing in left arm where she got the vaccine; soreness in the upper arm, in the forearm; throbbing and tingling in left arm where she got the vaccine; achy elbow 3 hours after the injection.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 40; Unit: Unknown) received BNT162B2 (Pfizer-Biontech covid-19 vaccine, Solution for injection, Lot number: EL3247, exp date not reported), via an unspecified route of administration on 28Jan2021 08:25 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient wanted to report a reaction that she had after receiving the Pfizer covid vaccine. She said she received the vaccine on site (not specified). On 28Jan2021, after receiving the vaccine she had achy injection site, soreness in the upper arm, in the forearm; throbbing and tingling in left arm where she got the vaccine; and achy elbow 3 hours after the injection. She said around 3 PM, she had swelling in the wrist, hand, and fingers; she had to remove the ring she was wearing. She also experienced muscle soreness in the left arm and difficulty in the lifting; soreness in shoulder, upper left quadrant, back, neck. Patient took ibuprofen for the events. The events improved over night and she just have some soreness the day of reporting.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,,,,,,"['Arthralgia', 'Back pain', 'Joint swelling', 'Muscular weakness', 'Myalgia', 'Neck pain', 'Pain in extremity', 'Peripheral swelling', 'Vaccination site pain', 'Vaccination site paraesthesia']",UNK,PFIZER\BIONTECH, 1065401,MO,84.0,M,"sore at inj. site; breaking out on legs and top of feet; This is a spontaneous report from a contactable consumer (patient himself). An 84-year-old male patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not available), via an unspecified route of administration on the left arm, on 28Jan2021 at 14:15 at single dose for COVID-19 immunisation. Medical history included diabetes and allergies, both from an unknown date. Concomitant medications included unspecified ""regular meds."" On 29Jan2021 at 19:00, it was reported that the patient experienced sore at inj. site and breaking out on legs and top of feet. No treatment was received. The events were considered as non-serious by the reporter. The events did not lead to death, life-threatening condition, hospitalization, disabling/incapacitating, or congenital anomaly. The patent has not been diagnosed with COVID 19 prior to vaccination and has not been tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior. The outcome of the events was unknown. The patient was vaccinated at a hospital. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/29/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Allergy; Diabetes,,,"['Skin reaction', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1065402,NC,75.0,F,"thought it was my tooth bleeding because that's what it looked like if you cut yourself; the phlegm she spitted up this morning had blood in it; she started to bleed/nose bleed coming out of my mouth; achy; tired; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) via an unspecified route of administration on 28Jan2021 08:05 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included an unspecified sinus disorder, unspecified allergies and reflux usually after eating, all from unknown dates and unknown if ongoing. The patient's historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) on 06Jan2021 with no specified side effects. The patient's concomitant medications were reported as unspecified medications for sinus problems and allergies. The patient stated that she got the second dose on ""Thursday."" She experienced side effects ""that everybody has like achy and tired for two days."" She continued to say that she normally spits up phlegm in the morning from sleeping overnight because she has sinus issues and she snores. This morning (""Saturday"") it was pinched with blood and she was bleeding, just bleeding. She's not bleeding anymore because she has a mouthwash medication to make gargles and also with salty water. She thought it was her tooth bleeding because that's what it looked like if you cut yourself. It has stopped. She also noted that it was more like a nose bleed coming out of her mouth. She gargled with warm salted water. Treatment of the events blood in sputum, nose bleed and tooth disorder included using a mouthwash medication to make gargles and also warm salt water. The clinical outcomes of achey and tired for two days were reported as unknown. The clinical outcomes of blood in sputum, nose bleed and tooth disorder were reported as recovered on an unspecified date in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Allergy NOS; GERD; Sinus disorder,,,"['Epistaxis', 'Fatigue', 'Haemoptysis', 'Pain', 'Tooth disorder']",2,PFIZER\BIONTECH, 1065403,,,F,"Sore throat; Pounding headache; Congested nose; Vomiting; Nausea; This is a spontaneous report from a contactable nurse (the patient). A female patient (Age: 26, Units: Unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 08Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she received the second dose of the Pfizer COVID vaccine on 08Jan2021, and her fiance tested positive after 2 weeks of it. She stated she had more symptoms than him, but she tested negative 3 times when she had the COVID tests done. Her fiance tested positive on 26Jan2021. The patient's symptoms were sore throat, pounding headache, congested nose, vomiting, and nausea, on an unspecified date. The patient wanted to know if the vaccine was preventing it to show positive and if this could be a false negative. The clinical outcome of sore throat, pounding headache, congested nose, vomiting, and nausea was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,,,UNK,,,,,,"['Headache', 'Nasal congestion', 'Nausea', 'Oropharyngeal pain', 'SARS-CoV-2 test', 'Vomiting']",2,PFIZER\BIONTECH, 1065404,FL,47.0,F,"Swollen lymph node left arm; This is a spontaneous report from a contactable Other Health Care Professional, the patient. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number El3264), intramuscularly on 28Jan2021 at 15:45 (at the age of 47-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included asthma from an unknown date and unknown if ongoing. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number El1284), on 07Jan2021at 16:40 in the left arm for COVID-19 immunization. The paktient has unspecified allergies to Penicillin. The patient previously too clindamycin (UNKNOWN MANUFACTURER) and experienced an unspecified allergy.The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Concomitant medications were not provided. On 28Jan2021 at 19:15, the patient experienced a swollen lymph node in the left arm. The patient did not receive any treatment for the event. The clinical outcome of swollen lymph node was reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Asthma; Penicillin allergy,,,['Lymphadenopathy'],2,PFIZER\BIONTECH,OT 1065405,TX,50.0,F,"dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purple on the center of it; My legs were hurting like really heavy; I have not gone back to sleep and I feel like a bus hit me.; chills; the body ache; legs hurt really bad; fever; symptoms associated with the flu for a few days; feeling like really bad headache; nauseated; not feel so good; This is a spontaneous report from a contactable nurse. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiration date: unknown), via an unspecified route of administration from 28Jan2021 to 28Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure. Concomitant medication included verapamil for blood pressure. The patient received her first dose of BNT162B2 on 08Jan2021 and experienced arms a little sore. On 28Jan2021 at 18:00, the patient started feeling like really bad headache and then really nauseated. The patient took medicine and took Tylenol before went in to take her shot and started getting a headache again and not feel so good. On 29Jan2021 at 02:00, the patient stated that her legs were hurting like really heavy and had not been back to sleep since 2 o clock in the morning and she felt like a bus hit her. On 29Jan2021 at 11:00, the patient stated that her finger on the left side was numb and it has a little bit of purple on the center of it. On 29Jan2021, the patient experienced chills, body ache, her legs hurt really bad, fever, symptoms associated with the flu for a few days. On 30Jan2021, the patient experienced arm swollen. On 01Feb2021, the patient experienced dizziness and migraine. The patient already took Tylenol and ibuprofen. The outcome of the event chills, fever, flu symptoms, arm swollen was recovered on an unspecified date and the outcome of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,VERAPAMIL,,Medical History/Concurrent Conditions: Blood pressure abnormal,,,"['Chills', 'Dizziness', 'Headache', 'Hypoaesthesia', 'Influenza', 'Insomnia', 'Limb discomfort', 'Malaise', 'Migraine', 'Nausea', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia']",2,PFIZER\BIONTECH, 1065406,FL,79.0,F,"Fever; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3286), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included clonidine, losartan and propranolol. It was reported that the patient called after the first shot also which was on the 8th. She called on 9th because she got a fever and I asked if she can take a medication because she is trying to figure out if it is same thing interacting with anything. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,,,UNK,CLONIDINE; LOSARTAN; PROPRANOLOL,,,,,['Pyrexia'],1,PFIZER\BIONTECH, 1065407,,,M,"positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer who reported for her husband via a Pfizer Sponsored Program, Pfizer First Connect. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that ""her husband received the first shot and tested positive for COVID-19. Her husband had fever, colds and sore throat."" The reporter wanted to know if her husband could still receive the 2nd dose of the vaccine. The clinical outcome of the event ""positive COVID-19 test with symptoms"" was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1065408,FL,79.0,F,"shot started to hurt; blood pressure was gone up; Fever; my head feels like it is going to explode; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) solution for injection, via an unspecified route of administration on 29Jan2021 at 08:30 at single dose for COVID-19 immunization. The patient has a lot of medical conditions (unspecified). Concomitant medications included unspecified medications. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 (lot number: EL3286) at single dose for COVID-19 immunization and experienced fever. The patient reported that she had her shot this morning (29Jan2021) at about 08:30 and towards evening, the shot started to hurt and so she wanted to make sure that it didn't go against anything, and put a little ice on it or maybe it was worthless on ice on certain situations after the fact that she thought this was too late. She wanted to make sure she could do that. The patient's blood pressure also went up on 29Jan2021. She was taking several different medicines for blood pressure. She took them already tonight. She was hoping that she will be feeling a little bit better. Sometimes, she gets a little fever on Jan2021, also like maybe 99 (unspecified). She just wanted to know if any of the medications were good or not for the shot. The patient was asking whether the drugs interacted. The patient also reported that when she took her first shot, she had a little fever and asked what she could take for it. An agent stated that she could take paracetamol (TYLENOL). The patient mentioned that she took her pills, otherwise, her head felt like it was going to explode on Jan2021. She took her high blood pressure medicines. She has three medications namely clonidine, losartan and propranolol. She has a lot of medical conditions that was why she was calling because she takes other medications. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/01/2021,,UNK,,,,,,"['Blood pressure measurement', 'Body temperature', 'Headache', 'Hypertension', 'Pyrexia', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1065409,NY,,U,"Skin allergic reaction at the site of pfizer covid 19 vaccine injection; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced skin allergic reaction at the site of Pfizer COVID 19 vaccine injection on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information about Lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination site hypersensitivity'],UNK,PFIZER\BIONTECH, 1065410,NC,75.0,F,"Severe allergic reaction; wheezing; felt right through her chest like through her right side kind of going into her left; it was weird like she could feel going into her body/ suddenly felt strange sensation in her chest; heart started beating really fast/ heart started beating very rapidly; face was all red/ face growing red and swelling slightly; face was all red/ face growing red and swelling slightly; breathing was becoming labored; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3248, NDC/UPC number and expiry date were unknown), via an unspecified route of administration in the right arm on 12Jan2021 at 10:00 AM at a single dose for COVID-19 immunization. The vaccine facility type was reported as the ""doctor's office/urgent care."" Relevant medical history included high blood pressure, but it was controlled blood pressure/hypertension; asthma, for which she was not taking medication at the time of the report, because it was under control; non allergic rhinitis; pre diabetes; and a little overweight. The patient further stated that she had just general medical history, which she had everything under control. Concomitant medications included lisinopril, montelukast sodium (SINGULAIR), atorvastatin (LIPITOR), acetylsalicylic acid (BABY ASPIRIN), and metformin. The patient previously took to iodine, doxycycline, erythromycin, and azithromycin, for which the patient had known allergies to all of it. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination. She was not tested for COVID-19 post vaccination. The patient stated that on 12Jan2021 at 10:30, she had adverse reactions to the Pfizer vaccine; she had severe allergic reaction within about 30 minutes and then they call the paramedic she ended up and they gave her a shot, which she did not know if it was prednisone. It was further reported that she took her inhaler too as they said she was wheezing, which she didn't really feel in her lungs. The patient just felt that what happen was she went to the car as they said to wait 15 minutes as written, and she always follow the rules and the whole thing they said, she waited 30 minutes, so she went down side of her car then she figured that she could just drive off drive home. So, she was in car sitting or waiting for the last 30 minutes and all of a sudden she felt right through her chest like through her right side kind of going into her left; it was weird like she could feel going into her body, then suddenly her heart start beating really fast, and then she pulled down the vizor and looked in the rearview mirror and her face was all red, so she go back to the site. That's how she transpired and then, that's how the reaction was. It was further reported that the patient waited 15 minutes in the office, then went to car to wait additional 15 minutes, and suddenly felt strange sensation in her chest and her heart started beating very rapidly. She pulled down the visor in car and saw her face growing red and swelling slightly and her breathing was becoming labored. She had read on side effects on information she was given on departure stating symptoms of an allergic reaction. She returned to the facility at which time she was treated. The adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit. The patient had no investigation assessment. Therapeutic measures were taken as a result of all the events, which included that the patient was given a shot of 125 mg of methylprednisolone sodium succinate (SOLU-MEDROL), but another report said they gave her prednisone so they were kind of conflicting in the report, but it was a shot, and also cetirizine (ZYRTEC) and famotidine (PEPCID), and her inhaler for wheezing. The patient recovered from all the events on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/12/2021,0.0,PVT,LISINOPRIL; SINGULAIR; LIPITOR [ATORVASTATIN]; BABY ASPIRIN; METFORMIN,,"Medical History/Concurrent Conditions: Asthma (not taking medication for that right now because it was under control); Hypertension (high blood pressure, but it was controlled blood pressure); Overweight; Prediabetes; Rhinitis",,,"['Chest discomfort', 'Dyspnoea', 'Erythema', 'Heart rate increased', 'Hypersensitivity', 'Swelling face', 'Wheezing']",1,PFIZER\BIONTECH, 1065411,FL,,F,"headache; This is a spontaneous report from a contactable consumer (the patient). A female patient (Age: 65, Units: Unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 08Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history included reactions to 'every vaccine' (unspecified). Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. Prior to receiving the first dose of Pfizer COVID-19 vaccine, the patient took ibuprofen (ADVIL) 600 mg. After the first dose, she took Advil again. In the second dose of the vaccine, initially she didn't take Advil, but 2 days after the second dose, she took Advil again. The patient wanted to know if that would affect the effect of the vaccine, since she confirmed that she was having this headache in any vaccine. The patient asked if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. She received her first Pfizer COVID vaccine; however, due to a history of reactions to 'every vaccine', she took 600 mg of Advil prior to her appointment. After her second dose, she took Advil for 2 days after due to her headache. The patient wanted to know how long after taking the COVID vaccine does Pfizer recommend taking the antibodies test, and if it was possible for her doctor to recommend a third dose of the COVID vaccine. The clinical outcome of headache was unknown. Information about Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Adverse event NOS,,,['Headache'],2,PFIZER\BIONTECH, 1065412,GA,,F,"experiencing upper leg pain (flu); This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program. A female patient of unknown age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unknown route of administration on 29Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unknown date. The patient experienced upper leg pain (flu) on an unknown date. The clinical outcome of the event upper leg pain was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,,,UNK,,,,,,['Pain in extremity'],2,PFIZER\BIONTECH, 1065413,TX,,F,"she took a Tylenol 1 hour before her covid vaccine; This is a spontaneous report from a contactable consumer via the Pfizer Sponsored Program. A 67-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunization. Medical history included ear infection. The patient's concomitant medications were not reported. The patient reported that she got the COVID-19 vaccine on Wednesday 27Jan2021. The Prior Sunday she developed inner ear infection, so she took Tylenol about an hour before the vaccine. She heard taking a pain reliever could lessen effectiveness if taken before shot. She took Tylenol about an hour before the vaccine, she inquired if that is okay. The clinical outcome was unknown. Information about Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Ear infection,,,['Circumstance or information capable of leading to medication error'],1,PFIZER\BIONTECH, 1065414,GA,,F,"she will take medication for her Sinus/she is having some sinus problems; This is a spontaneous report from a Pfizer-sponsored program. A 72-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (at the age of 72-years-old), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history included sinus problems ""this time of year and takes Mucinex DM for it."" Concomitant medications were not reported. On an unspecified date, she experienced some sinus problems. The clinical outcome of the event sinus problems was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Sinus disorder'],1,PFIZER\BIONTECH, 1065415,CA,,F,"suspected COVID-19 with symptoms; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-Sponsored Program, Pfizer First Connect. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on 30Dec2020 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that ""on 01Jan2021 she had COVID like symptoms. Her husband got COVID-19. She had not received her second dose because she was sick. Her second dose was supposed to be on 20Jan2021. She was scheduled to go back to work on 01Feb2021 and would be able to get a dose on 02Feb2021."" The patient wondered if she was supposed to start over or if she could just get the second dose. The clinical outcome of the event ""suspected COVID-19 with symptoms"" was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/30/2020,01/01/2021,2.0,UNK,,,,,,['Suspected COVID-19'],1,PFIZER\BIONTECH, 1065416,LA,,F,"her mom tested positive with Covid-19 vaccine; COVID-19 confirmed by postiive COVID-19 test; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program, Pfizer First Connect. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced a positive COVID-19 test on an unknown date. The clinical outcome of the event COVID-19 was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1065417,FL,75.0,F,"Lethargic; Flu like symptoms; Lower part of my leg, I have little bit rash, a redness; Lower part of my leg, I have little bit rash, a redness; I have few spots on my right forearm; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration at the age of 75 years, on 22Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing and anticoagulant therapy from an unknown date and unknown if ongoing. Concomitant medication included dronedarone hydrochloride (MULTAQ) at 400mg, twice daily and apixaban (ELIQUIS) at 5mg, two times daily. The patient stated, ""Both my husband and I took the Covid the first shot on 22Jan2021 which was week ago today. I noticed about 4 days later (Jan2021) like I started feeling you know flu like symptoms but they were mild, if I took two an Extra strength Tylenol it went away. You know what I mean. So that one for about may be one, two may three days and that was it. I was very lethargic. The only thing I did notice that on both my legs from the ankles of about midways I have you know my leg, the lower part of my leg, I have little bit rash, a redness. It does not itch, it was not hard to the touch. My body temperature was normal. It was little red or pinkish to a little bit of red. Now, I noticed tonight that I have few spots on my right forearm. Like I said we have shot on 22nd, everything was fine, no immediate reaction or anything else and everything is okay. I just you know I feel fine but is this normal?"" The patient stated, ""No, they are healthy and safe about 20-25 minutes. Everything was fine and then let us go and I said couple of days later it hasn't progressed, it is very, it is on both of my lower legs from ankles midway up my legs and I noticed couple of spots on my left forearm but it hasn't gotten any worst and it hasn't gotten spread on any place other than right forearm."" The patient also stated, ""You mean the rash or any other the symptoms. We have the shot Friday, Saturday, Sunday, Monday. I was say this past Tuesday, around 26th (further not clarified)."" The patient stated, ""It was there on my legs. It hasn't moved. It hasn't gotten any worse and it is only on front it is not back on my legs. The only thing I noticed tonight that it is couple of spots on my right forearm."" The consumer stated, ""No, I went to see my doctor the other day for her to take look at it. I went to see PA at my doctor's office, I saw her and she said if it doesn't get worse it would probably go away."" The patient also stated, ""The only thing that I had done right before the Covid Vaccine. I had injection in my knee of amniotic fluid for a torn meniscus but that should not affect it."" The patient underwent lab tests and procedures which included body temperature: normal on an unspecified date. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/01/2021,,UNK,MULTAQ; ELIQUIS,,"Medical History/Concurrent Conditions: Anticoagulant therapy (Concomitant medications: Consumer stated, ""I am on a blood thinner.""); Atrial fibrillation (Verbatim: Atrial fibrillation/Additional Information for Other Conditions: Consumer stated, ""I do take medicine for it."")",,,"['Body temperature', 'Erythema', 'Influenza like illness', 'Lethargy', 'Rash', 'Rash macular']",1,PFIZER\BIONTECH, 1065418,,28.0,F,"significant lymph node swelling; body aches; unable to walk/stand; unable to walk/stand; chills; headache; sore throat; This is a spontaneous report from a non-contactable nurse. A 28-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 21Jan2021 at single dose for COVID-19 immunisation. Medical history included asthma, fibromyalgia, anxiety, depression and known allergies: penicillin. Concomitant medication included escitalopram oxalate (LEXAPRO), loratadine (CLARITIN [LORATADINE]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). The patient previously took first dose of BNT162B2 on 02Jan2021 on the left arm. The patient experienced significant lymph node swelling, body aches, unable to walk/stand, chills, headache, sore throat on 21Jan2021.The patient received no treatment. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,PUB,LEXAPRO; CLARITIN [LORATADINE]; FLONASE [FLUTICASONE PROPIONATE]; BREO ELLIPTA,,Medical History/Concurrent Conditions: Anxiety; Asthma; Depression; Fibromyalgia; Penicillin allergy,,,"['Chills', 'Dysstasia', 'Gait inability', 'Headache', 'Lymphadenopathy', 'Oropharyngeal pain', 'Pain']",2,PFIZER\BIONTECH, 1065419,NC,84.0,F,"My face is swelled; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration (at the age of 84years) on 29Jan2021 at 09:00 at single dose for covid-19 immunisation and diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration from an unspecified date at unspecified dose and frequency for an unspecified indication. Medical history included have a pacemaker. Concomitant medications were unspecified as stated, ""I am taking lot of medication."" The patient reported, ""My face is swelled"" on 29Jan2021. Consumer stated, ""I got the Pfizer vaccine today and I looked in a mirror a couples of hours ago and my face is swelled. So, my question is should I take diphenhydramine hydrochloride or not? It got a little better but it is still swollen. I wonder if I took diphenhydramine hydrochloride would that be helpful. I am getting better."" There was no treatment for the event. The action taken in response to the event for diphenhydramine hydrochloride was unknown. The outcome of the event was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,UNK,BENADRYL,,Medical History/Concurrent Conditions: Artificial cardiac pacemaker user,,,['Swelling face'],UNK,PFIZER\BIONTECH, 1065420,WI,71.0,M,"pain at the injection site; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number FF09262), via an unspecified route of administration on 28Jan2021 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had pain at the injection site with the Covid-19 vaccine. It has been over 21 hours. Is due for the second one on 18Feb2021. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,UNK,,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1065421,CA,,M,"Coughing and nasal symptoms are listed as possible signs of Covid19 infection; reporting body aches; fever; watery eyes; sneezing; dry cough; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID19 VACCINE), via an unspecified route of administration on 08Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history included Exposure to SARS-CoV-2 (around an elderly co-worker that tested positive for Covid19 infection). Concomitant medications were not reported. The patient experienced body aches (not 'itch' as reported), fever, watery eyes, sneezing, and a dry cough. Caller wanted to know if these symptoms are normal? Coughing and nasal symptoms were listed as possible signs of covid19 infection. The patient had been around an elderly co-worker that tested positive for Covid19 infection, caller did not find out until after receiving his first dose. He spent 4 - 5 hours with him, before getting his shot. If he tests positive for Covid19 infection, how does that affect his next dose which was scheduled for 01Mar2021? The outcome of the events was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,,,UNK,,,Medical History/Concurrent Conditions: Exposure to SARS-CoV-2 (around an elderly co-worker that tested positive for Covid19 infection),,,"['Cough', 'Lacrimation increased', 'Pain', 'Pyrexia', 'Sneezing', 'Suspected COVID-19']",1,PFIZER\BIONTECH, 1065422,SC,72.0,F,"Not feeling very energetic; I did not feel good; Chills; Fever; Headache; Did not feel like eating much; Achy; This 72- year-old female patient contactable consumer (reported for herself) received the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot EL9265; expiration not provided), via an unspecified route of administration, on 28Jan2021 at 09:15 AM (at the age of 72-years-old) as a single dose for COVID-19 immunization. The facility where COVID-19 vaccine was administered was at a hospital. Medical history included: COVID in Mar2020 and was hospitalized for 10 days, hypertension, thyroid disorder, and flu shot. Concomitant medication included: Hydrochlorothiazide 12.5 mg, once a day for blood pressure and medication for thyroid reported as: ""NP"" 0.5gms. On 28Jan2021 later on after vaccine, she reported 9:15 pm that she did not feel good. She had chills, fever, headache, did not feel like eating much, was achy, and not feeling very energetic. During the night temperature was 101.4. At 8 in the morning, I started taking 2 Tylenol, 500 mg and it went lower but then it would come back up, so I take more. So, it never went over 101.8. now here we are on the Saturday morning and I am not feeling very energetic and I still have just a 99 temperature. Treatment included: Tylenol. The clinical outcome of the events I did not feel good, chills, fever, headache, did not feel like eating much, Not feeling very energetic, and Achy were unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/01/2021,,PVT,HYDROCHLOROTHIAZIDE; NP THYROID,,Medical History/Concurrent Conditions: Blood pressure abnormal (Verbatim: Blood pressure); COVID-19 (I had COVID in Mar2020 and was hospitalized for 10 days); Thyroid disorder (Verbatim: Thyroid),,,"['Asthenia', 'Body temperature', 'Chills', 'Decreased appetite', 'Headache', 'Malaise', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1065423,IL,,M,"Joint pain; Soreness in the arm; Temperature went up to like 101 degrees/fever; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), lot number: EH9899, via an unspecified route of administration on 23Jan2021 as single dose for COVID-19 immunization. Medical history included none. There were no concomitant medications. The patient stated he had the COVID shot a week ago and as of now, he has no symptoms until the soreness in the arm but that was natural. The patient had joint pain starting yesterday, day before and today like it was his temperature, it went up to like 101 degrees. The patient was asking if that is normal. The patient stated the fever was today which is 29Jan2021 and still experiencing. The patient took couple Tylenol. The outcome of the event fever was not recovered as of reporting time; while the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,01/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Body temperature', 'Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1065424,NC,,U,"congested; nauseous; threw up; itchiness; red spots on my arm; I lost my taste and I feel not having taste right now; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Two hours after receiving the vaccine on 27Jan2021, the patient experienced a really bad reaction, itchiness, and red spots on the arm. Around 11:00 on 27Jan2021, the patient got nauseous and threw up. The patient went home and lay down, woke up and lost taste on an unspecified date. The patient felt not having taste ""now"" on 30Jan2021. On 30Jan2021 the patient was really congested. The outcomes of itchiness, red spots on the arm, nauseous, and threw up were unknown. The outcomes of lost taste and really congested were not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/01/2021,,UNK,,,,,,"['Ageusia', 'Erythema', 'Nasal congestion', 'Nausea', 'Pruritus', 'Vomiting']",2,PFIZER\BIONTECH, 1065425,ID,26.0,F,"It seems like she was drunk; it was almost like disorientation like; Had trouble processing like formulating sentences; she had trouble listening and her 'attention' stammered very much; Injection site swelling; Stammer; Pain; This is a spontaneous report from a contactable consumer. This consumer reported for a 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown) via an unspecified route of administration on 30Jan2021 at SINGLE DOSE for covid-19 immunisation which was administered by her employer. Medical history was none. There were no concomitant medications. The reporter stated that about 2 hours after the administration of the vaccine ""it was almost like disorientation like she was kind of, it seemed like she was drunk. She had trouble processing/formulating sentences. She had trouble listening and her 'attention' stammered very much."" No treatment received for reported events. The reporter reported that she seemed better now. The outcome of the reported events was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Disorientation', 'Disturbance in attention', 'Dysphemia', 'Feeling drunk', 'Pain', 'Speech disorder', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 1065426,IL,50.0,M,"Dizzy; nauseous; exhausted; soreness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient, who is 50-year-old the date of vaccination, received bnt162b2 (BNT162B2), lot number: EL8982, via an unspecified route of administration on Arm Left, on 28Jan2021 12:00 as SINGLE DOSE (second dose) for COVID-19 immunization. Medical history included High Blood Pressure. The patient received first dose of bnt162b2 (BNT162B2), lot number=EL3248, on 07Jan2021 at 12:00 on left arm. Concomitant medication included hydrochlorothiazide. On 28Jan2021 12:15, the patient experienced dizzy, nauseous, exhausted, soreness. The outcome of the events was not recovered. No treatment was received for the events. The patient did not have COVID prior vaccination. The patient was not tested post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,PVT,HYDROCHLOROTHIAZIDE,,Medical History/Concurrent Conditions: Blood pressure abnormal,,,"['Dizziness', 'Fatigue', 'Nausea', 'Pain']",2,PFIZER\BIONTECH, 1065427,,88.0,F,"tested positive for the Covid virus on 02Feb; tested positive for the Covid virus on 02Feb.; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 3 patients. This is 3rd of 3 reports. An 89-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Pharmacy technician, calling on behalf of three patients who tested positive after receiving the first dose of the Covid vaccine, asked when they can get the second dose of the Covid vaccine. They received their first dose on 16Jan2021 and tested positive for the Covid virus on 02Feb2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021138460 same drug/event, different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,02/02/2021,17.0,UNK,,,,,,"['Drug ineffective', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1065428,,88.0,F,"Sore arm at injection site; chills; fatigue; This is a spontaneous report from a contactable consumer. A non-pregnant 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONN), via an unspecified route of administration, in the left arm, on 28Jan2021 (at the age of 88 years) as a single dose for COVID-19 immunization. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Jan2021, the patient experienced sore arm at injection site, chills, fatigue. The patient did not receive any treatment for the sore arm at injection site, chills, fatigue. The clinical outcome of sore arm at injection site, chills, fatigue was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,,,,,,"['Chills', 'Fatigue', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1065429,SC,,F,"2 days post injection general malaise; Injection site soreness 4 hours post injection; This is a spontaneous report from a non-contactable consumer, the patient. This elderly female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL 9265), dose 1 , single dose via an unspecified route of administration in the left arm on 26Jan2021 at 12:00 PM for COVID-19 vaccination. There was no relevant medical history. There were no known allergies. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 26Jan2021 at 05:00 PM, the patient experienced injection site soreness 4 hours post injection. On 28Jan2021 2 days post injection, the patient had general malaise. No treatment was received for the events. The clinical outcome of injection site soreness and general malaise was recovered on an unknown date. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Malaise', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1065430,OR,,F,"Severe epigastric pain for one hour with nausea, then nausea/queasy/sore abdomen for 24 hours.; Severe epigastric pain for one hour with nausea, then nausea/queasy/sore abdomen for 24 hours.; Severe epigastric pain for one hour with nausea, then nausea/queasy/sore abdomen for 24 hours.; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EK9231); via an unspecified route of administration in the Left arm, on 06Jan2021 at 12:45 as SINGLE DOSE for covid-19 vaccination. Medical history included hypothyroidism. Concomitant medication in two weeks of received vaccine was received (details were not provided). The patient previously took lisinopril and experienced drug hypersensitivity. The facility in which the vaccine was given was a hospital. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 06Jan2021 at 14:00 The patient experienced Severe epigastric pain for one hour with nausea, then nausea, queasy and sore abdomen for 24 hours. Treatment included Zofran sublingual as a result of severe epigastric pain, nausea/queasy and sore abdomen. The clinical outcome of the events Severe epigastric pain was recovered on 06Jan2021 at 15:00 which nausea, queasy and sore abdomen was recovered on 07Jan2021. No follow up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Hypothyroidism,,,"['Abdominal pain', 'Abdominal pain upper', 'Nausea']",1,PFIZER\BIONTECH, 1065431,NY,24.0,F,"Full body chills; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in Jan2021 (at the age of 24-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included anxiety and depression. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. In Jan2021, the patient experienced full body chills. No treatment was provided for the event body chills. The outcome of the event body chills was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021145063 same reporter/patient/vaccine, different dose/event",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,LEXAPRO,,Medical History/Concurrent Conditions: Anxiety; Depression,,,['Chills'],1,PFIZER\BIONTECH,OT 1065432,MO,68.0,F,"multiple bilateral Pulmonary emboli; pulmonary hypertension; short of breath; right heart strain; This is a spontaneous report from a contactable nurse. A 68-year-old female patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number=EH9899), via an unspecified route of administration at right arm on 22Dec2020 08:00 AM at single dose for COVID-19 immunisation. Medical history included uveitis, arthritis and known allergies: pine nuts. The patient did not have COVID prior vaccination. The patient did not test for COVID post vaccination. The patient was not pregnant. Concomitant medication included prednisone (eye gtt), naproxen as needed (PRN) less than weekly. The patient previously took theophylline and experienced allergies. The day after getting the first dose of vaccine the patient worked all day in another (clinic withheld). She felt well all day, but at 6 pm when she left to go to her car she was so short of breath she had to stop twice to get there. Subsequent work up has shown that she had multiple bilateral Pulmonary emboli resulting in pulmonary hypertension and right heart strain. Adverse event start date was 23Dec2020. Adverse event start time was 06:00 PM. The adverse events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 1 day, Life threatening illness (immediate risk of death from the event)]. Therapeutic measures were taken as a result of the events included Lovenox and Eliquis. The outcome of the event was recovering.; Sender's Comments: Based on available information and known drug profile the reported events are unlikely related to bnt162b2 . These are probably intercurrent medical condition. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,1.0,Not Reported,N,12/22/2020,02/23/2021,63.0,PVT,PREDNISONE; NAPROXEN,,Medical History/Concurrent Conditions: Allergy to nuts; Arthritis; Uveitis,,,"['Dyspnoea', 'Heart injury', 'Pulmonary embolism', 'Pulmonary hypertension']",1,PFIZER\BIONTECH, 1065433,,,M,"stroke; blood clot in the heart; Hospitalization with racing and irregular heart beat; Hospitalization with racing and irregular heart beat; loss of motor function; This is a spontaneous report from a non-contactable consumer. A 46-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer) on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. If other vaccine in four weeks was unknown. Other medications in two weeks was unknown. If covid prior vaccination was unknown. If covid tested post vaccination was unknown. Known allergies was unknown. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer) on an unspecified date for COVID-19 immunization. Patient experienced hospitalization with racing and irregular heartbeat, blood clot in the heart, stroke, loss of motor function on an unspecified date. Treatment included intubation. The outcome of the events was unknown. Events resulted in hospitalization, life threatening illness (immediate risk of death from the event). No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Yes,Yes,,Not Reported,U,,,,UNK,,,,,,"['Cerebrovascular accident', 'Heart rate', 'Heart rate increased', 'Heart rate irregular', 'Intracardiac thrombus', 'Motor dysfunction']",2,PFIZER\BIONTECH, 1065434,FL,47.0,M,"Patient died; This is a spontaneous report from a contactable consumer (parent's patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route on 13Feb2021 (at the age of 47-year-old) at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 18Feb2021 the patient died. The cause of death was unknown. An autopsy was not performed. No COVID prior vaccination. The patient had not been tested for COVID post vaccination. Information about lot/batch number has been requested.; Reported Cause(s) of Death: Patient died",Yes,02/18/2021,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/18/2021,5.0,UNK,,,,,,['Death'],UNK,PFIZER\BIONTECH, 1065435,NC,81.0,F,"blood clot; death cause: Heart Problems; tired; nauseous; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3248), via an unspecified route of administration at single dose in the left arm on 19Jan2021 14:00 for covid-19 immunisation. Medical history included heart problems, pacemaker. Concomitant medication included heparin. The patient experienced death cause: heart problems on 20Jan2021, blood clot on an unspecified date with outcome of unknown that required hospitalization, tired on 19Jan2021 with outcome of unknown, nauseous on 19Jan2021 with outcome of unknown. The patient was hospitalized for blood clot from 16Jan2021 to 18Jan2021. The patient died on 20Jan2021. An autopsy was not performed. The events were described as follows: The patient was tired and nauseous about 3 hours after her vaccine. She had been in the hospital 16Jan2021 to 18Jan2021 for a blood clot. The patient died at her home on 20Jan2021 between 4 and 7 pm. No treatment required. The vaccine was administered at Hospital Facility. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.; Reported Cause(s) of Death: death cause: Heart Problems",Yes,01/20/2021,Not Reported,Yes,2.0,Not Reported,N,01/19/2021,01/19/2021,0.0,PVT,HEPARIN,,Medical History/Concurrent Conditions: Heart disorder; Pacemaker insertion (cardiac),,,"['Cardiac disorder', 'Fatigue', 'Nausea', 'Thrombosis']",1,PFIZER\BIONTECH, 1065436,AK,44.0,M,"small heart attack; myocardial/paracardial issues.; My injection location had redness, hardness; My injection location had redness, hardness; pains in chest; headache; chill; running nose; shortness of breath.; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 19Feb2021 17:45 at single dose for COVID-19 immunisation at hospital. Medical history included coronary artery disease. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on unknown date for covid-19 immunisation. The patient did not have covid before vaccination. The patient experienced small heart attack and myocardial/paracardial issues on an unspecified date with outcome of unknown. These events were serious as life threatening, disability and requiring hospitalization from 21Feb2021 till 23Feb2021 at 14:00. On 20Feb2021 07:00 the patient experienced headache, chill, running nose, shortness of breath with outcome of recovering. The patient experienced also pains in chest on 21Feb2021 11:00 with outcome of recovering and injection location had redness, hardness on an unspecified date with outcome of recovering. Clinical course was as follows. 19Feb2021-5:45pm the patient went to receive vaccine shot. 20Feb2021 the patient had headache, chill, runny nose, and shortness of breath. 21Feb2021 11am still had shortness of breath and pains in chest. Went to clinic had a rapid Covid test come back negative, pain increased and he went to emergency room. The patient was admitted to the hospital with small heart attack and myocardial/paracardial issues. Inflammatory response seems to possibly triggered possible underlying issue of minor heart disease. Then induced heart attack and myocardial issue. The patient would gladly be admitted to a clinic for observation and testing to assist Pfizer in understanding this unfortunate situation. The injection location had redness, hardness. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment due to the event which included multiple lab tests, Angiogram, CR scan and pain medicine.",Not Reported,,Yes,Yes,2.0,Yes,N,02/19/2021,02/20/2021,1.0,PVT,,Coronary heart disease,,,,"['Angiogram', 'Cardiomyopathy', 'Chest pain', 'Chills', 'Dyspnoea', 'Headache', 'Laboratory test', 'Myocardial infarction', 'Rhinorrhoea', 'SARS-CoV-2 antibody test', 'Scan', 'Vaccination site erythema', 'Vaccination site induration']",2,PFIZER\BIONTECH, 1065476,,,F,"After her 2nd shot she felt something trickle down her arm; Possible underdose; A spontaneous report was received from a healthcare professional concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced events like Vaccine under dose and Vaccination complication. The patient's medical history not provided. The patient's concomitant not provided On 13th FEB 2021, the patient received their second of two planned doses of mRNA-1273 intramuscularly in the anatomical location for prophylaxis of COVID-19 infection. The patient experienced onset of events of After her 2nd shot she felt something trickle down her arm, possible under dose, and Side effects from the 2nd vaccine were much less than the first. Treatment was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the reported events was unknown.; Reporter's Comments: This report refers to a case of Vaccine underdose and exposure via skin for nRNA-1273 with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history provided),,,"['Exposure via skin contact', 'Underdose']",1,MODERNA,OT 1065477,PA,27.0,F,"Some of the dose ran down the patient's elbow; dose running down patient's elbow; A spontaneous report (UNITED STATES) was received from a pharmacist concerning of a 27 years old, female patient, who received Moderna's COVID-19 vaccine, and who experienced dose of vaccine running down patient's elbow (accidental underdose) (exposure via skin contact). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 15 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot number 010M20A) intramuscularly for COVID-19 prophylaxis. During the administration, the vaccine ran down the patient's elbow, and the patient experienced accidental underdose and exposure via skin contact. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was resolved on 15 Feb 2021.; Reporter's Comments: This report refers to a case of accidental underdose and exposure via skin for mRNA-1273 with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Accidental underdose', 'Exposure via skin contact']",2,MODERNA,OT 1065478,VA,,F,"Viral meningitis; A spontaneous report from was received from reporter concerning a patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) on 13 Jan 2021. The patient's medical history was not provided. No relevant concomitant medications were reported. On13 January 2021, the patient received their first dose of mRNA-1273 (lot/batch: Unknown) intramuscularly in the unknown Anatomical location for prophylaxis of COVID-19 infection. Patient diagnosed with mild viral meningitis on 3rd February 2021. Patient experienced intense headaches and sickness. Patient got discharged on 12 February 2021. Treatment for the event included anti viral drip, Celebrex, Benadryl, Tylenol, Elavil. Action taken with mRNA-1273 in response to the events was not reported. The outcome of viral meningitis was not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,7.0,Not Reported,N,01/13/2021,02/03/2021,21.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Meningitis viral'],1,MODERNA,OT 1065479,NY,,U,"dose given comprised of multiple vials; A spontaneous report was received from a healthcare professional concerning an unknown patient who received Moderna's COVID-19 vaccine (mRNA-1273) and stated that the dose given comprised of multiple vials No patient details were provided. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events, the patient/patients received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) for prophylaxis of COVID-19 infection. The reporter stated that 12FEB2021 1 patient would have received a dose from multiple vials and on 13FEB2021 2-3 patients may have received doses from multiple vials. Laboratory details if provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event ( dose given comprised of multiple vials ) was recovered/resolved..; Reporter's Comments: This case concerns a patient of unknown age and gender who had a nonserious unexpected event of Product preparation issue with mRNA-1273 (lot # 031L20A) without associated adverse events. Reporter stated a ""pharmacy pre-filled syringes and combined the contents of multiple vials to make a single dose, and that multiple patients may have received doses from multiple vials"". Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Product preparation issue'],1,MODERNA,OT 1065480,NV,,F,"patient has not received the second dose yet and more than 2 months has passed since first dose; A spontaneous report was received from a consumer concerning a female patient who experienced patient has not received the second dose yet and more than 2 months has passed since first dose. The patient's medical history was not provided. No concomitant products were provided. On 15-JAN-2021, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The patient was supposed to get the second dose on 12-FEB-2021, but the facility only had the Pfizer vaccine. The patient tried going to another distribution center but the patient could not get a dose. The patient had an appointment for the second dose on 25-MAR-2021, but that will be more than two months after the first dose. The patient was trying to get a different date for the second dose. Action taken with mRNA-1273 in response to the event was reported as unknown. The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of patient has not received the second dose yet and more than 2 months has passed since first dose for mRNA-1273 (lot# unknown), with no associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (no medical history reported),,,['Inappropriate schedule of product administration'],1,MODERNA,OT 1065481,NV,,F,"concerned that didn't get the entire dose; during administration, some of the liquid dropped on arm; A spontaneous report was received from a nurse, who was also a female patient (age not reported), who received Moderna's COVID-19 vaccine (mRNA-1273) and during administration, some of the liquid dropped on arm (exposure via skin contact) so she was concerned that she didn't get the entire dose (accidental underdose). The patient's medical history was not provided. No concomitant product use was reported. The patient received their first of two planned doses of mRNA-1273 (batch number unknown) on an unknown date. On 16 Feb 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (batch number unknown) for prophylaxis of COVID-19 infection. On 16 Feb 2021, during administration of the vaccine, some of the liquid dropped on her arm so she was concerned that she didn't get the entire dose. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events. Therefore, the action taken with the drug in response to the events was not applicable. The events, during administration, some of the liquid dropped on arm and was concerned that didn't get the entire dose, were considered recovered/resolved on 16 Feb 2021.; Reporter's Comments: This report refers to a case of accidental underdose and exposure via skin contact for mRNA-1273 (lot # unknown), with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,UNK,,No adverse event (No medical history provided),,,,"['Accidental underdose', 'Exposure via skin contact']",1,MODERNA,OT 1065482,CA,,M,"Received a double dose / pt received 1mL for the dose; A spontaneous report was received from a healthcare professional concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a double dose/accidental overdose. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient was given a double dose. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event patient received 1mL for the dose was recovered.; Reporter's Comments: This case concerns a male patient of unknown age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Accidental overdose without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Accidental overdose'],1,MODERNA,OT 1065483,,,U,"patient under the age of 18 received the 1st dose of the vaccine; A spontaneous report was received from a pharmacist concerning a patient under the age of 18 that received the first dose of Modern's COVID-19 vaccine (mRNA-1273) . The patient's medical history was not provided. No concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. No laboratory details were provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events, patient under the age of 18 received the first dose of the vaccine, was not reported. The outcome of the event, patient under the age of 18 received the first dose of the vaccine, was considered recovered/resolved.; Reporter's Comments: This case concerns a patient under the age of 18 who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1065484,PR,,U,"Vials storage error; 10 patients were vaccinated from that vial; A spontaneous report was received from a pharmacist, concerning ten patients who were administered Moderna's COVID-19 vaccine from a vial temporarily stored at 17.7 �F/product storage error and out of specification product use. The patients' medical histories were not provided. Concomitant product use was not provided by the reporter. On 16 Feb 2021, ten patients received one of two planned doses of mRNA-1273 (Batch number 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 16 Feb 2021, the freezer door at the pharmacy was left slightly open which resulted in a temperature increase to 17.7 �F for one hour and 25 minutes. After visual inspection by the pharmacist, all vial were reportedly still frozen. The pharmacist thawed 1 vial, and 10 patients were vaccinated from that vial. The pharmacist noted that the temperature of the freezer containing the remaining 29 vials was -11.0 �F at the time of reporting. Action taken with mRNA-1273 in response to the event was not provided. The event, 10 patients vaccinated from a vial temporarily stored at 17.7 �F, was considered resolved on 16 Feb 2021.; Reporter's Comments: This report refers to a case of Product storage error (vaccine from a vial temporarily stored at 17.7 �F, and administered to ten patients) for mRNA-1273, lot # 029L20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No adverse event reported),,,"['Out of specification product use', 'Product storage error']",1,MODERNA,OT 1065485,,,F,"received second dose of vaccine on day 27 instead of day 28; A spontaneous report was received from a consumer concerning a female patient (demographics not provided) who received the second dose of Moderna vaccine on day 27 instead of day 28. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On unknown date, the patient received their first of two planned doses of mRNA-1273. On unknown date, the patient received their second dose of mRNA-1273 (route and site of administration were not provided) for prophylaxis of COVID-19 infection. On an unknown date, the patient was administered the second dose of vaccine before day twenty-eight. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of the event received second dose of vaccine on day 27 instead of day 28 was resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273 with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Inappropriate schedule of product administration'],2,MODERNA, 1065486,MA,53.0,F,"administered a 0.3 ml dose instead of the 0.5 ml dose; A spontaneous report was received from a consumer concerning a 53-year-old, female patient who received Moderna's COVID-19 vaccine and was administered a 0.3 ml dose (MedDRA PT: Incomplete dose administered). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 15 FEB 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly for prophylaxis of COVID-19 infection. On 15 Feb 2021, the patient received a call from the pharmacy where she received her vaccine. Patient reports that the lady giving the dose was not used to giving Moderna Covid-19 Vaccine and administered a 0.3 ml dose instead of the 0.5 ml dose. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the event was unknown. The event, administered 0.3 ml dose, was considered recovered/resolved 15 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, with no associated AEs.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-015255:Lnked case- Sister case",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical History),,,['Incorrect dose administered'],1,MODERNA,OT 1065487,MA,,M,"Received a invalid dose of 0.3 ml; A spontaneous report, was received from a consumer (patient's sister), concerning a male patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and resulted in patient received an invalid dose of 0.3 ml (underdose). The patient's medical history was not provided. Concomitant mediation was not reported. On 15 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), intramuscularly for the prophylaxis of COVID-19 infection. The patient's sister received a call from the pharmacy, and it was reported that the patient received Moderna COVID-19 Vaccine on 15 Feb 2021. The patient's sister reported that the lady giving the dose was not used to give Moderna Covid-19 Vaccine and administered a 0.3 ml dose to the patient instead of the 0.5 ml dose. Treatment information was not provided. Action taken with second dose of mRNA-1273 in response to the event was unknown. The event, received an invalid dose of 0.3 ml, was considered recovered/resolved on 15 Feb 2021.; Reporter's Comments: This report refers to a case of vaccine underdose administered to a male patient for mRNA-1273, (lot # not reported) with no associated AEs.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-015236:Lnked case- Sister case",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported Medical History),,,['Underdose'],1,MODERNA,OT 1065488,MA,,F,"Received 0.3 ml vaccine for first shot; A spontaneous report, was received from a consumer (patient), a female patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and resulted in patient received 0.3 ml vaccine for first shot (underdose). The medical history of patient was not provided. Concomitant medication was not provided. On 16 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), intramuscularly for the prophylaxis of COVID-19 infection. The patient confirmed that she received her first shot of Moderna COVID-19 Vaccine on 16 Feb 2021, and got a call from the pharmacist that she got a lesser dose of 0.3 ml instead of 0.5 ml. But there was no problem if the patient received more than 0.25 ml, or more and the patient will still receive her second shot. The patient was worried and would like to know if the pharmacist said was true and if the dose given to her was effective or not and needs to be repeated. No treatment mediation information was provided. Action taken with second dose of mRNA-1273 in response to the event was unknown. The event, received 0.3 ml vaccine for first shot, was considered recovered/resolved on 16 Feb 2021.; Reporter's Comments: This report refers to a case of underdose for mRNA-1273, with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Underdose'],1,MODERNA,OT 1065489,MD,42.0,M,"Arm has been sore; Chills; when she administered the vaccine she squirted the vaccine on me; nurse then drew up additional vaccine and administered 0.3mL; A spontaneous report was received from a consumer concerning a 42-year-old, male patient who was participating in the mRNA-1273 Emergency Use Program and experienced accidental underdose, extra dose administered, arm has been sore and chills. The patient's medical history not provided. Concomitant medications not provided. On 16-JAN-2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The patient reported that when he received the vaccine, the nurse squirted some of the liquid on him. He stated that she then went and got more vaccine and administered an additional 0.3mls. Additionally, he stated that on 17-JAN-2021, his arm was sore and he had chills. Treatment included Aleve. Action taken with mRNA-1273 in response to the events, accidental underdose, extra dose administered, arm has been sore and chills, was not provided. The events, accidental underdose and extra dose administered, were considered recovered/resolved. The outcome of the events, arm has been sore and chills, was unknown.; Reporter's Comments: This case concerns a 42 year old, male patient, who experienced a non-serious expected event of vaccination site pain, and chills, 2 days after receiving 1st dose of mRNA- 1273 (Lot# Unknown). This report also refers to a case of wrong technique in device usage process and accidental overdose for mRNA-1273 (lot # 028L20A), with no associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history provided),,,"['Accidental overdose', 'Chills', 'Vaccination site pain', 'Wrong technique in device usage process']",1,MODERNA,OT 1065490,,,M,"Received both doses 11 days apart; A spontaneous report, was received from a pharmacist, concerning a male patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and resulted in patient received both doses 11 days apart (inappropriate schedule of product administration). The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of event, the patient received their second planned dose of mRNA-1273 (Lot number: unknown), intramuscularly for prophylaxis of COVID-19 infection. The pharmacist reported that the patient received both doses of Moderna COVID-19 vaccine 11 days apart. No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the event was not applicable. The outcome of the event, received both doses 11 days apart, was considered as recovered on an unknown date.; Reporter's Comments: This case concerns a male patient of unknown age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting inappropriate schedule of product administration without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Inappropriate schedule of product administration'],2,MODERNA,OT 1065491,CO,,F,"Accidently given First dose to 17 year old; A spontaneous report , was received from a pharmacist, concerning a 17 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No relevant concomitant medications were reported. On 18 Jan 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly for the prophylaxis of COVID-19 infection. The pharmacist called in to ask and confirm if he should give the second dose to a 17-year-old patient, who had been accidently given her first dose at the same pharmacy on 18 Jan 2021. The pharmacist did not have any additional patient identifier, or any other information related to this event. No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, accidently given first dose to 17-year-old, was recovered on 18 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/18/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1065492,WA,,U,"20 doses were administered to patients from vials with temperature excursion; A spontaneous report was received from a reporter like Health care professional mRNA-concerning 20 patients who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced temperature excursion and said 20 doses were administered to patients from this excursion (out of specification product use). The patients' medical histories were not provided. No relevant concomitant medications were reported. On an unspecified date, the vaccine was in liquid form stored at an appropriate temperature in the refrigerator. The temperature then went to 18 degrees Fahrenheit (F), 15 F, 14 F, 12 F, then 11.8 F, and each temperature change was in 5 minute intervals for a total of 20 minutes temperature excursion, and vials were still in liquid form. The vials were then taken out of refrigerator and left at room temperature. On an unknown date, prior to the onset of the events, the patients' received their first of the two planned doses of mRNA-1273 (lot/batch-NA) for prophylaxis of of COVID-19 infection. Twenty doses were administered to patients from this temperature excursion. Laboratory details were not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was resolved.; Reporter's Comments: This report refers to a case of out of specification product use of 20 doses for mRNA-1273 with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Out of specification product use'],1,MODERNA,OT 1065493,TX,73.0,F,"black bruise at the injection site; concerned that vaccine was not administered intramuscularly; A spontaneous report was received from a patient concerning a 73-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a big black bruise the size of a silver dollar around 3x3 inches at the injection site and was concerned maybe the vaccine was not intramuscularly administered. The patient's medical history was not provided. Concomitant medications reported included blood pressure medication and cholesterol medication, however, no product information was provided. On 27-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 004M20A) in the left arm for prophylaxis of COVID-19 infection. Patient reported that approximately 1-2 days following vaccine administration, she developed a big black bruise about the size of a silver dollar at the injection site. Additionally, she reported that she was concerned that the vaccine may not have been administered intramuscularly. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, developed a big black bruise the size of a silver dollar around 3x3 inches at the injection site, was considered recovering/resolving. The event, concerned maybe the vaccine was not intramuscularly administered, was considered recovered/resolved.; Reporter's Comments: This case concerns a 73-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot 004M20A) reporting Incorrect route of product administration and Vaccination site bruising. Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Incorrect route of product administration', 'Vaccination site bruising']",1,MODERNA,OT 1065494,WI,16.0,F,"16 year old received the vaccine; A spontaneous report was received from a pharmacist concerning a 16-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event inappropriate age at vaccine administration. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the events, the 16-year-old patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. Laboratory details was not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, inappropriate age at vaccine administration, was considered recovered/resolved.; Reporter's Comments: This case concerns a 16-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1065495,FL,,F,"Vaccine administered to high in shoulder; Some of the vaccine dripped down arm; A spontaneous report was received from a consumer concerning a 68-year-old female patient, who received Moderna's COVID-19 vaccine to high in shoulder and some of the vaccine dripped down arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On 18 Feb 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of Covid-19 infection. The patient stated that the vaccinator administered vaccine too high in the shoulder and some of the vaccine dripped down arm. No further information was provided. Treatment information was unknown. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events ""some of the vaccine dripped down arm"" and ""vaccine administered to high in shoulder"" was unknown.; Reporter's Comments: This report refers to a case of underdose, product administered at inappropriate site, and exposure via skin contact for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,PHM,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Exposure via skin contact', 'Product administered at inappropriate site']",1,MODERNA,OT 1065496,NY,,F,"Some of the vaccine dripped out; some of the vaccine dripped out; A spontaneous report was received from a Consumer concerning a 45 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced device connection issue and vaccine under dose. The patient's medical history was not provided. No relevant concomitant medications were reported. On 19 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 030M20A) in the left non-dominant arm for prophylaxis of COVID-19 infection. On 19 Feb 2021, the patient experienced vaccine dripped out. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events vaccine underdose and device connection issue was unknown.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # 030M20A) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Device connection issue', 'Underdose']",1,MODERNA,OT 1065497,CT,,M,"Vaccinated a pediatric patient; A spontaneous report was received from a healthcare professional concerning a 17 year old pediatric patient who received Moderna's COVID-19 vaccine (mRNA-1273) accidently. No relevant medical history is provided. No relevant concomitant medications were provided. On 19 Feb 2021, prior to the onset of the events, the patient received there first of two planned doses of mRNA-1273 (batch: unknown) for prophylaxis of COVID-19 infection. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event vaccinated to pediatric patient was resolved.; Reporter's Comments: This report refers to a case of Inappropriate age at vaccine administration for mRNA-1273, lot # unknown, with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1065498,CO,,M,"Vaccine leaked on the site of injection; Didn't receive full vaccine; A spontaneous report was received from a consumer concerning a 73-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced the vaccine leaked on the site of injection (vaccination site discharge) and didn't receive full dose of vaccine (underdose). The patient's medical history was not reported. The patient received their second of two planned doses of mRNA-1273 (Batch number: Batch number not provided) on 9 FEB 2021, intramuscularly for prophylaxis of COVID-19 infection. On 09 FEB 2021, Patient reported the vaccine leaked on the site of injection and thinks didn't receive full dose of vaccine. Action taken with the drug in response to the events was not applicable as the patient received both doses. The outcome of the events, vaccine leaked on the side of injection and patient didn't receive a full dose, was resolved on 09 Feb 2021.; Reporter's Comments: This report refers to a case of underdose and vaccination site discharge for mRNA-1273. There were no reported adverse events associated with this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Underdose', 'Vaccination site discharge']",2,MODERNA,OT 1065499,IL,41.0,F,"Administration lower than the deltoid muscle (she thinks); A spontaneous report was received from a nurse concerning a 41-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) administration lower than the deltoid muscle (Vaccine administered at inappropriate site). The patient's medical history was not provided. No relevant concomitant medications were reported. On 26 Jan 2021, prior to the onset of the event administration lower than the deltoid muscle, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 038K20A) in the right arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient had her second dose of the vaccine on her right arm and she thinks the placement of vaccination was incorrect, lower than the deltoid muscle. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event administration lower than the deltoid muscle was considered recovered.; Reporter's Comments: This report refers to a case of Vaccine administered at inappropriate site for mRNA-1273 (lot/batch: 038K20A) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Product administered at inappropriate site'],2,MODERNA,OT 1065500,CA,,M,"given 1ml dose instead of .5ml; A spontaneous report was received from a consumer concerning a 34-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and given 1ml instead of .5ml/accidental overdose. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient was given 1ml instead of .5ml. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event given 1ml instead of .5ml was considered recovered.; Reporter's Comments: This report refers to a case of Accidental overdose for mRNA-1273. There were no reported adverse events associated with this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Accidental overdose'],1,MODERNA,OT 1065501,VA,16.0,U,"vaccine administered to 16 year old; A spontaneous report was received from a physician assistant concerning a 16 year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine administered to 16-year old. The patient's medical history was not reported. No relevant concomitant medications were reported. On an unknown date, 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On an unknown date, the 16 year old patient was administered the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The event, vaccine administered to 16-year old, was considered resolved on an unknown date.; Reporter's Comments: This is a case of 16-year-old female patient who was administered mRNA-1273 (Inappropriate age at vaccine administration) (Lot #: unknown). There was no associated adverse event reported for the event of Inappropriate age at vaccine administration.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (no medical history reported),,,['Product administered to patient of inappropriate age'],1,MODERNA, 1065502,MN,,F,"16 year old female who received her first dose of the Moderna COVID-19 vaccine by accident; A spontaneous report was received from a consumer concerning a 16 year old female patients who received Moderna's Covid 19 vaccine (mRNA1273) first dose by accident. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 28-DEC-2020 the patient received first of two planned dose of mRNA-1273 (Batch Number 026L20A) intramuscularly for prophylaxis of Covid 19 infection. Patient received first dose of the Moderna COVID-19 vaccine by accident on 28-DEC-2020. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The outcome of the event, inappropriate age at vaccination were considered as recovered/resolved.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273 (Batch Number 026L20A) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history provided.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1065507,MI,83.0,F,"EXTREME PAIN, STOPPED EATING/DRINKING -- STARTED MORPHINE",Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/24/2021,1.0,OTH,YES,DEMENTIA,DEMENTIA,,,"['Fluid intake reduced', 'Hypophagia', 'Pain']",1,MODERNA,SYR 1065515,SC,82.0,F,"From admitting hospitalist: received 2nd dose of ""COVID vaccine"" on 2/16. Felt fine until approx. 2 days later when she experienced increasing fatigue and ""feeling poorly"" . Stated she spent most of the last week in bed due to severe fatigue. Admitted to the hospital 2/28/2021 with new onset Afib with rapid ventricular rate and new diagnosis of CHF with fluid overload upon arrival.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/16/2021,02/18/2021,2.0,OTH,,,hypothyroid,,Latex,"['Atrial fibrillation', 'Cardiac failure congestive', 'Cardiac monitoring', 'Chest X-ray', 'Echocardiogram', 'Fatigue', 'Feeling abnormal', 'Heart rate increased']",UNK,PFIZER\BIONTECH, 1065523,NJ,41.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/19/2021,02/19/2021,0.0,UNK,,,,,,"['Abdominal pain', 'Burning sensation', 'Chest discomfort', 'Chest pain', 'Cough', 'Dizziness', 'Dyspnoea', 'Nausea', 'Oropharyngeal discomfort', 'Pain', 'Paraesthesia', 'Paraesthesia oral', 'Pruritus', 'Rash', 'Swelling face', 'Throat tightness', 'Urticaria']",2,PFIZER\BIONTECH, 1065543,NC,78.0,M,"It was reported to staff that this gentleman suffered thrombocytopenia following his vaccine, a platelet infusion was done and he expired on 2-14-21",Yes,02/14/2021,Not Reported,Yes,,Not Reported,N,01/15/2021,02/14/2021,30.0,PUB,unknown,unknown,unknown,,NKDA,"['Death', 'Platelet transfusion', 'Thrombocytopenia']",1,MODERNA,IM 1065546,MD,81.0,M,"2/28/21 Patient presented and was admitted through the emergency department for confusion, weakness, and low grade temperature (100.1 F). On admission, pertinent labs were Hgb of 5.1, WBC 60k which was consistent with autoimmune hemolytic anemia (AIHA).. Patient was diagnosed with chronic lymphocytic leukemia in 2016. The patient has had a prior history of AIHA in 2017. Per the Agency, hospitalizations are to be reported irrespective of attribution to vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,,02/08/2021,02/26/2021,18.0,PVT,,,,,,"['Asthenia', 'Body temperature increased', 'Condition aggravated', 'Confusional state', 'Haemoglobin decreased', 'White blood cell count increased']",2,MODERNA,IM 1065551,GA,68.0,M,"Pt received 2nd Pfizer BioNTech Covid 19 EUA vaccine @1:50 pm; Pt released from Observation @2:09 pm. Approximately 2:18 pm RN called to parking lot and observed pt having difficulties. Called for EMS & crash cart. Vitals taken 2:20 BP 83/55, no respirations noted, pt unresponsive. AED attached. EMS arrived 2:22 and took over care of pt. and transported @2:40 pm to Hospital. Per wife, pt has history of PE in Oct. 2020, HTN, diabetes with insulin pump, obesity, gastroparesis, home oxygen and uses motorized scooter. Wife also said pt had allergy to iodine not previously reported, and MD had stopped Zarelto subsequent to 1st Pfizer vaccine 2/8/21 ""due to breathing difficulty"". Patient was unable to be resuscitated. Time of death 14:59.",Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,N,03/01/2021,03/01/2021,0.0,PUB,"Insulin, fentanyl patch","Diabetes, HTN, obesity","Diabetes, HTN, obesity, history of MI @ 2011, PE 10/2020, gastroparesis, on home oxygen",,None reported,"['Blood glucose increased', 'Cardioversion', 'Death', 'Dyspnoea', 'Respiratory arrest', 'Resuscitation', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 1065676,ME,83.0,M,Patient was admitted at Hospital from 2/11/2021 to 2/17/2021 after a fall with presyncope. Patient sustained head trauma with scalp laceration and staple were placed. Patient has longstanding history of atrial fibrillation and has been taking Eliquis. He was initially seen in the office complaining of fatigue blaming it on the Eliquis that was started. Patient had a Covid vaccination on 2/8/2011. Patient denies any respiratory symptoms. No cough no chills no fever. Complain of exertional shortness of breath. He was seen in the emergency room at and tested positive for COVID-19.,Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,02/08/2021,02/11/2021,3.0,PVT,"Apixaban 2.5 mg BID, tadalafil 20 mg PRN, Ocuvite 1 tab daily, multivit 1 tab daily",None,"ED, Hyperglycemia, Atrial fibrillation, hiatal hernia,",,Cephalexin (rash),"['Atrial fibrillation', 'COVID-19', 'Dyspnoea', 'Fall', 'Fatigue', 'Head injury', 'Presyncope', 'SARS-CoV-2 test positive', 'Skin laceration']",1,MODERNA,IM 1065677,AZ,67.0,F,"UNKNOWN COVID VACCINE BRAND. 67 y.o. female presenting to the emergency department with a chief complaint of right sided numbness onset 2000 last night. Patient received her first dose of the COVID-19 vaccine at 1200 yesterday. She states she was feeling okay prior to 2000. Patient states she then developed numbness to the right side of her head, right arm, and right leg. She called EMS and was evaluated at her home. Patient was hypertensive at the time but was told she did not need to come to the ED. Afterward she took a Benadryl and went to bed. She states the benadryl just made her sleepy but did not improve her numbness. This morning she woke up still feeling numb and called her PCP. The RN she spoke to recommended she come to the ED. She is dizzy but she states this is normal per her baseline. States HTN previously resolved.",Not Reported,,Not Reported,Yes,1.0,Yes,U,02/08/2021,02/08/2021,0.0,PVT,"amitriptyline, gabapentin, progesterone, hctz",,"neurogenic cough, hypertension, hypoparathyroidim, multinodular goiter, osteoporosis, allergic conjuntivitis, anxiety, depression, impaired glucose tolerance; hx of cholecystectomy, augmentation mammoplasty, tubal ligation, tonsillectomy",,none,"['Angiogram', 'Angiogram cerebral abnormal', 'Arterial stenosis', 'Cerebral artery stenosis', 'Dizziness', 'Hypertension', 'Hypoaesthesia', 'Magnetic resonance imaging head abnormal', 'Thalamic infarction']",1,MODERNA,IM 1065697,OH,69.0,M,"2/19/2021- PCP visit for 1-week history of constipation, malaise and bilateral leg weakness . Abnormal sCr and LFTs AKI: likely ATN from rhabdomyolysis. Requiring HD 2/23/2021 initial hemodialysis 2/23/2021 kidney biopsy 3/1/2021 second hemodialysis",Not Reported,,Not Reported,Yes,7.0,Yes,N,02/12/2021,02/19/2021,7.0,PUB,"Crestor 40 mg daily, aspirin 81 mg every other day, Metformin 1000 mg daily, Naproxen 500 mg daily",none,"Diabetes Melitus Type 2, hyperlipidemia, obesity",,NKDA,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Biopsy kidney', 'Blood creatine phosphokinase increased', 'Blood creatinine increased', 'Constipation', 'Haemodialysis', 'Malaise', 'Muscular weakness', 'Renal tubular necrosis', 'Rhabdomyolysis']",1,MODERNA,IM 1065702,MD,82.0,M,"Presented to the emergency department on 2/28/21 with exertional shortness of breath and upper abdominal discomfort for the past 2 days. Patient was admitted to the hospital, and pulmonary edema was contributed to right-sided heart failure from his mild COPD and suspected underlying interstitial lung disease. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine. This hospitalization does not appear to be related to the vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,,02/24/2021,02/26/2021,2.0,PVT,,Recently admitted to the hospital with hypotension and non-ST elevation MI (1/12 - 1/13),COPD,,,"['Abdominal discomfort', 'Chronic obstructive pulmonary disease', 'Dyspnoea', 'Dyspnoea exertional', 'Interstitial lung disease', 'Pulmonary oedema', 'Right ventricular failure']",1,PFIZER\BIONTECH,IM 1065712,PR,78.0,M,"Patient started feeling weak, stomach pain, neck pain, respiratory problems, confusion, low blood pressure which led to death on February 21, 2021, 7 days after the vaccine was given.",Yes,,Not Reported,Yes,,Not Reported,N,02/14/2021,02/18/2021,4.0,PHM,,,"Diabetes Mellitus, CA Bladder",,,"['Abdominal pain upper', 'Asthenia', 'Confusional state', 'Death', 'Dyspnoea', 'Hypotension', 'Neck pain']",UNK,MODERNA, 1065719,OH,84.0,M,"My grandpa got his second covid vaccine on Thursday. Saturday he complained of stiff neck. Sunday he had low grade fever, nausea and vomiting, chills, and mild headache. He was feeling bad enough to call squad at 3 pm. The paramedics did evaluation and thought he was just experiencing normal side effects from vaccine and felt no need to transport to hospital so my grandpa decided to stay home and just rest. At 2 am that same night he went into cardiac arrest and was not able to be brought back",Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,,02/18/2021,02/22/2021,4.0,PHM,simvastatin carvedilol glipizide pantoprazole,,chf copd dm,,,"['Cardiac arrest', 'Chills', 'Death', 'Feeling abnormal', 'Headache', 'Musculoskeletal stiffness', 'Nausea', 'Pyrexia', 'Vomiting']",UNK,MODERNA, 1065720,VA,77.0,M,"Poor PO intake, fevers at night, body aches, excessive somnolence/sleeping, and a progressive exquisitely tender erythematous maculopapular rash. The patient acquired a Stevens-Johnson like syndrome which required a three day inpatient stay and the consultation of Infectious Disease and Dermatologic consultants. Per his SCORTEN score, he had roughly a 3% chance of mortality from the event. He was closely monitored for signs of decompensation but did not have excessive desquamation or duskiness after treatment was initiated. With IV steroids and IV rehydration, the patient improved over the hospitalization course and labs were essentially back to normal a week later on follow up.",Not Reported,,Yes,Yes,3.0,Not Reported,Y,02/11/2021,02/12/2021,1.0,PVT,ASPIRIN 325 MG EC TABLET Take 325 mg by mouth daily. �ATORVASTATIN (LIPITOR) 40 MG TABLET Take 40 mg by mouth daily. �EZETIMIBE (ZETIA) 10 MG TABLET Take 10 mg by mouth daily. �FAMOTIDINE (PEPCID) 40 MG TABLET Take 40 mg by mou,None,"CAD, HTN, HLD, OA",,Tetanus toxoid (unspecified reaction and severity) Horse derived products (anaphylaxis),"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood alkaline phosphatase increased', 'Blood chloride decreased', 'Blood creatine phosphokinase increased', 'Blood creatinine increased', 'Blood sodium decreased', 'C-reactive protein increased', 'C-reactive protein normal', 'Decreased appetite', 'Eosinophil count increased', 'Full blood count', 'Hypophagia', 'Leukocytosis', 'Metabolic function test normal', 'Neutrophil count decreased', 'Pain', 'Pain of skin', 'Pyrexia', 'Rash erythematous', 'Rash maculo-papular', 'Red blood cell sedimentation rate increased', 'SCORTEN score', 'Somnolence', 'Stevens-Johnson syndrome', 'Troponin', 'Urine analysis normal', 'White blood cell count normal']",2,MODERNA,IM 1065723,CA,41.0,F,Parasthesias/Peripheral Nueropathy throughout body,Not Reported,,Not Reported,Not Reported,,Yes,N,02/05/2021,02/12/2021,7.0,PHM,"Zyrtec, Pepcid, postnatal vitamin","On and off itching without a rash, no known reason",Psoriasis,,None,"['Laboratory test normal', 'Magnetic resonance imaging normal', 'Neuropathy peripheral', 'Paraesthesia', 'Vitamin B6 increased']",1,MODERNA,IM 1065728,OH,71.0,F,"About 1 hour and 15 minutes after receiving the vaccine I became dizzy. 3 1/5 hours later I developed chills which lastly briefly. The next day I had huge area on my left eye on my pupil which lasted for 5 days. I have blue eyes and right at toward the end of the blue I have white deposits. On 2/24/2021 I went see an eye doctor Dr. He diagnosed me with ""whiss"" ring around both of my eyes, and seen spot on my lenses on my left eye. I started starburst with my left eye, this did not develop until after I received the vaccine. I have a dot on my right eye now. On 02/26/2021 see another eye doctor Dr., he also said I have deposits around my cornea, acknowledged the starburst effect on the left eye, and noticed the ""whiss"" ring. Since I took the vaccine my eyes have become very light sensitive. The doctors have told me this conditions are permanent, if it gets worse they will have to scrape the eye and have a laser surgery. I do not remember when it started but it 2inches by 3 inches, red patch which started at the injection site and went diagonal.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/09/2021,02/09/2021,0.0,PUB,"Montelukast 10 MG daily, Losartan 100 MG daily, Metformin HCL 500 MG twice a day, Pentoxifylline ER 400 twice a day, Pravastatin 10 MG daily, Levocetirizine 10 MG daily, Calcium 315 MG 1.5 tablets, Vitamin D 625 MCG 1.5 tablets daily, Mult",,"Obstructive Sleep Apnea (wears a CPAP), Congestive Heart Failure, Diabetes, Asthma, Kidney Disease stage 2, Hypertension, Obesity, Eustachian tube, arthritis, Carpel Tunnel syndrome, back and neck problems, Hemorrhoids, Chronic Sinus problems (retention cysts),","Reaction to both Pneumonia vaccines, Prevnar 13 in 2016 and Pneumovax 23 in 2017, I did get a sore arm and had trouble lifting m","Lamotrigine, (anaphylactic reaction to Augmentin), Lisinopril, Crestor, Lipitor, Recliast, Pletal, Gastrographin, Protonix, Rice, Shrimp, Mustard, Spinach, beats, Chocolate, dust, grass, weeds, trees,","['Chills', 'Deposit eye', 'Dizziness', 'Erythema', 'Injection site erythema', 'Injection site reaction', 'Intraocular pressure test', 'Mydriasis', 'Ophthalmological examination abnormal', 'Photophobia', 'Retinal deposits', 'Visual impairment', 'Vitreous detachment']",1,MODERNA,SYR 1065740,MD,88.0,M,"2/28/2021 patient was admitted for rectal bleeding while taking apixaban Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine. This hospitalization does not appear to be related to the vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,,02/25/2021,02/28/2021,3.0,PVT,,,,,,['Rectal haemorrhage'],1,MODERNA,IM 1065749,MO,84.0,M,"blurred vision, dizzeness, passed out went to hospital by ambilance heart rate was 40",Not Reported,,Yes,Yes,1.0,Not Reported,Y,02/22/2021,02/22/2021,0.0,PUB,"Amlodipine 2.5 daily, aspirin 81 daily, atenolol 25 mg daily, atorvastatin 40 mg daily, clopidogrel 75 mg daily, ferrous sulfate 325 mg every other day, losartan 50 mg daily, multivit-mimeral-iron-lutein tablet daily, vitamin C 250 table","hearth condition, had blatter cancer in 2019 vein problems in legs surgery in 2019",heart condition,,Lisinopril Rash,"['Dizziness', 'Loss of consciousness', 'Vision blurred']",1,MODERNA,IM 1065756,TX,77.0,F,Unknown Covid vaccine; no known side effects; postmortem Covid-19 test negative Date of death: 02/22/2021,Yes,,Not Reported,Not Reported,,Not Reported,,,,,UNK,,,,,,"['Death', 'SARS-CoV-2 test negative']",UNK,UNKNOWN MANUFACTURER,UN 1065765,TX,78.0,F,No known side effects; postmortem Covid-19 test negative Date of death: 02/16/2021,Yes,,Not Reported,Not Reported,,Not Reported,,01/18/2021,,,UNK,,,,,,"['Death', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,UN 1065906,,,U,partial dose; A spontaneous report was received from a pharmacist concerning a partial dose Modern's COVID-19 vaccine (mRNA-1273) received. The patient's medical history was not provided. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported.; Reporter's Comments: This report refers to Product administration error with no associated AEs for mRNA-1273.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Incorrect dose administered'],1,MODERNA,OT 1065907,CA,,F,"partial first dose; A spontaneous report was received from a Healthcare Provider (HCP) concerning an unknown age female patient who was administer Moderna Covid- 19 Vaccine patient only received a partial dose. It was reported by the register nurse is the Director at vaccine clinic, and they had a patient received a partial first dose, wanted to see recommendation for that patient. The reported was unaware that this will be reported as an adverse event AE. The patient medical history was not provided, no concomitant medications were reported. On 05 Feb 2021, the patient received her first dose of two dose of mRNA-1273(Batch number 007M20A) for prophylaxis of COVID-19 infectious route unknow. It was reported by the Register Nurse the patient only received a partial dose. The patient was administered first dose of mRna-1273 Vaccine. the patient only received a partial dose. Action Taken with the second dose, is unknown. The event patient reported only received a partial dose was administrated was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # 007M20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Incorrect dose administered'],1,MODERNA,OT 1065908,TN,74.0,F,"Atrial fibrillation; A spontaneous report was received from a consumer, concerning herself, a 74-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced medically important event of atrial fibrillation. The patient's medical history included heart surgery on an unspecified date in 2017. No concomitant medications were reported. On 05 FEB 2021, prior to the onset of event, the patient received their second of two planned doses of mRNA-1273 (batch number: 015L20A) for the prophylaxis of COVID-19 infection. On an unspecified date in FEB 2021, the patient experienced fast heart rate, felt weakness, dizziness, and had atrial fibrillation. No treatment medication information was provided. Action taken with second dose of mRNA-1273 in response to the event was not applicable. The outcome of the event, atrial fibrillation was not reported.; Reporter's Comments: Based on current information the event was assessed as unlikely related to mRNA-1273 vaccine, because of biological implausibility, no clear temporal association, and the patient's history of heart surgery which may promote atrial fibrillation episodes.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Cardiac operation (Procedure of Heart surgery),,,['Atrial fibrillation'],2,MODERNA,OT 1065909,TX,48.0,M,"Stroke; A spontaneous report was received from a consumer concerning a 48-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke (cerebrovascular accident). The patient's medical history was not provided by the reporter. Concomitant product use was not reported. On 30 Dec 2020, approximately 11 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot #: 037K20A) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection. The reporter stated that on 10 Jan 2021, the onset of symptoms of stroke began. The patient reports that he was discharged from the hospital on 20 Jan 2021 and was later discharged from patient rehabilitation on 26 Jan 2021. Treatment for the event included apixaban, acetylsalicyclic acid, and atorvastatin as advised by patient's HCP (health care provider). Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, stroke, was unknown.; Reporter's Comments: This case concerns a 48 year old male who experienced stroke 11 days after the vaccine was administered. Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Yes,Yes,,Yes,U,12/30/2020,01/10/2021,11.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Cerebrovascular accident'],1,MODERNA,OT 1065910,MA,34.0,F,"Miscarriage; Received vaccine when pregnant; A spontaneous report was received from a 34-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) when pregnant and experienced a miscarriage. The patient's medical history included three prior pregnancies, with two live births and one miscarriage. Products known to have been used by the patient, within two weeks prior to the event, included prenatal vitamins and doxylamine succinate/pyridoxine hydrochloride. The patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) on 30 Dec 2020. On 27 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. At 7 weeks gestation, the fetus had a normal heart beat. She reported that she had no complications with the pregnancy. On 08 Feb 2021, the patient had a miscarriage. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The events received vaccine when pregnant and miscarriage were considered recovered.; Reporter's Comments: This report concerns a 34-year-old, P2G4 who experienced miscarriage 1 month 9 days post administration of first dose and 12 days after the last dose of mRNA-1273 vaccine. There is not enough information such as the last menstrual period, estimated date of conception and delivery and gestational age at the time of miscarriage. In addition, the patient's detailed medical history including any trauma and reason for previous miscarriage is lacking. Vaccine exposure during pregnancy is assessed as not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,12/30/2020,0.0,UNK,PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; BONJESTA,,Medical History/Concurrent Conditions: Miscarriage (18 May 2021); Pregnancy (live birth on 21 Feb 2016); Pregnancy (live birth on 08 Mar 2018),,,"['Abortion spontaneous', 'Exposure during pregnancy']",1,MODERNA,OT 1065911,IL,,M,"Double vision; FATIGUED; A spontaneous report was received from a consumer concerning a 65-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced double vision and fatigue. The patient's medical history, as provided by the reporter included cancer, diabetes, hypertension, celiac disease and whipple's operation. No concomitant medications were reported. On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029K20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient experienced double vision and fatigue. The patient was advised by the eye doctor to go into the emergency room (ER) if the symptoms didn't subside. However, it was reported that the vision did get better. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The event, double vision, was considered resolved on an unknown date. The outcome for the event fatigue was unknown.; Reporter's Comments: Based on the current available information, a strong temporal association between the use of the product and the onset of the reported event, a causal relationship cannot be excluded. Fatigue is consistent with the known safety profile of the mRNA-1273 vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/22/2021,1.0,UNK,,Cancer; Celiac disease; Diabetes; Hypertension,Medical History/Concurrent Conditions: Whipple's operation,,,"['Diplopia', 'Fatigue']",1,MODERNA,OT 1065912,WA,17.0,F,"Gave vaccine to 17 year old; A spontaneous report was received from a nurse concerning a 17-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event, gave vaccine to a 17-year-old/inappropriate age of dose of administration. The patient's medical history was not provided. Concomitant medications were not reported. On 05 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A) for prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient received the vaccine resulting in the event of inappropriate age of dose of administration. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, gave vaccine to a 17-year-old, was considered resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 013M20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (NO reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1065913,CA,91.0,F,"she couldn't urine/She couldn't urinate anymore; she couldn't urine, patient tried for a long time in the bathroom and only got a few drops of urine out; Always had burning on bottom of her foot/she felt like her body was burning up in side/Felt like she was burning alive; Had a fever every day and every night/Temperature was 100 degrees; she has an infection in her bladder; feel like I am dying/had a very strange feeling in her body/Something was going across the top and right side like a fluid was flowing or something strange; sweating/wet, perspiring all night./Got all wet with perspiration; gotten more sick; weak; tired; headache; lost a little weight; Eats very little now; afraid; pain was around the bottom of the foot now it's on top of the foot and goes up to knee; uncomfortable; sneezes; diarrhea; cramps; constipation; colon cancer; doesn't think the needle went in all of the way when the nurse administered her vaccine; shingles; Post herpetic neuralgia/the post-herpetic neuralgia was on her whole foot; pain at the bottom of my foot; impact on the nervous system; This is a spontaneous report from a contactable consumer (patient). This 91-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EN5318), via an unspecified route of administration on 02Feb2021 at single dose in the left arm for COVID-19 immunization. The patient medical history included high blood pressure, kidney cancer, cancer in her bladder 20 years ago and coughing. The patient's concomitant medications included ergocalciferol (VIT D), ascorbic acid (VIT C), losartan potassium for blood pressure, metoprolol succinate for blood pressure, amlodipine for blood pressure, acetylsalicylic acid (ASPIRIN 81). Patient had cancer in her bladder 20 years ago. That was taken care of. Had kidney cancer because her husband used to smoke and blow it in her face. Had rare type of kidney cancer. It was removed. Treated for bladder cancer. Patient has had no problem ever since and that was more than 18 years ago. Patient had a fever, headache, and was very tired. Burning up on side of the body and she got all wet. This was not normal and she felt like she was dying. Patient stated she had shingles and developed post herpetic neuralgia. Patient always had pain at the bottom of her foot but it was getting worse after she received the first dose of Pfizer COVID-19 vaccine. Patient noticed the liquid going thru arm to chest and in straight line to her leg, like a science fiction movie with an injection of some kind. The doctor thought the vaccine might have an impact on the nervous system and spike the symptoms of post herpetic neuralgia. Patient spoke to her doctor but nobody knows anything. Nobody was willing to help her. Patient felt like she was dying. She didn't want to die. Patient feel the symptoms are getting worst. She was burning up inside. Her pain was around the bottom of the foot now it's on top of the foot and goes up to knee. Patient was not blaming anybody but she thought it was the vaccine. Patient was sweating, wet, perspiring all night. The symptoms usually occur at night. Patient wanted to know if these symptoms were associated with the vaccine. Patient also mentioned she developed a bladder infection for which she was taking antibiotics. Patient had Pfizer vaccine on 02Feb2021, about 5 days ago. Patient followed instructions before vaccine. Doctor said to take paracetamol (TYLENOL) before the vaccine for a headache. Patient did that. Patient had injection and told to wait for 15 minutes before she went home. About 5 minutes, she was relaxed and sitting down. Vaccination given in left arm. All of a sudden she had a very strange feeling in her body on 02Feb2021. Something was going across the top and right side like a fluid was flowing or something strange. Then it felt like a straight line down her right foot and it stopped. Was a feeling like maybe the liquid of the vaccine went that way. Didn't have a vein going that way. Patient was afraid. She went home and didn't remember the next thing that happened. Every night she has gotten more sick. Patient had a feeling in her foot where she had shingles a few years ago. After shingles had post-herpetic neuralgia. Patient always had burning on bottom of her foot and would put it in ice water. Patient could handle that because it was just uncomfortable. After injection, she got so bad, the post-herpetic neuralgia was on her whole foot and it started to burn. It went up a little towards the knee or higher. Yesterday, at times, it quickly went over to the left leg. Patient had a fever every day and every night. Patient took paracetamol to cut the fever. Patient was coughing on call but stated that was nothing and the coughing was something she had. Every night she felt like her body was burning up in side. Felt like she was burning alive. Got all wet with perspiration. She changed clothes and every night it got worse. Patient called emergency, they listened to her, stating they have never heard of anything like this. Asked patient if she wanted to go to emergency. She stated ok. The doctor listened to her story and told her it was weird. Doctor told her to give it a few more days to up to eight days. Doctor wanted her to get a urine test, but she couldn't urine, patient tried for a long time in the bathroom and only got a few drops of urine out and it was brown. Not normal urine. Next day patient called 911. She wanted to be assured she was not dying at home. Did have room available at the hospital. Patient had to sit in a wheelchair and there was no bed for her to lie down in. Last time she was admitted from the emergency. Next day she came home and had to call emergency again. Really thought she was burning up. Patient didn't want to go to the hospital and suffered at home. Next night and third night was so bad. Patient couldn't urinate anymore. She had a fever, but not a high fever, because the paracetamol cut the fever. Temperature was 100 degrees. On the inside she thought she was being burned up a live. Never got better, always got worse. Yesterday, she was in the hospital all day. Now she has an infection in her bladder. Was put on a machine and everything. Had a long procedure, and got the urine going. Patient didn't miss not urinating. Has accidents like when she sneezes or cough. Usually gets up 2-3 times at night to urinate. When she finally realized she couldn't urinate, the doctor kept her there for a long time, eight hours. Was put on the machine, thought she may need a catheter. Her bladder was massaged in order to get her to urinate. Patient only had the left kidney. Correct problem about the urine. Doctor told her to make sure she goes back for second dose on 23Feb2021, but she was afraid. In the morning she was a little better, couldn't handle this. Patient was very weak and tired. One night she was in the emergency and didn't sleep because of the procedures. Patient didn't think the needle went in all of the way when the nurse administered her vaccine. Sensation started on the left, went across her chest, straight down like an arrow. Like something was trickling down to the end of her foot and stopped. Patient had symptoms every night since. So severe patient thought she was burning up. Patient got worse every night and didn't get any better. Patient said feeling at COVID-19 Vaccine injection site was not a natural thing. Last time she was in the hospital her blood pressure went up to 184. After COVID-19 Vaccine patient lost a little weight. Same time had this problem, was seeing a doctor with a colon specialty. Had so much constipation for a long time and tried to correct it with mediation. Medication was too strong and gave her diarrhea. Doctor thought maybe she had colon cancer. Stopped the medication. Wasn't 100% healthy, but that was just cramps. Patient eats very little now, not very hungry. Patient feels good in her bowels after something good from a restaurant. Patient attempted to clarify the medication that was too strong. She stated it was over the counter. She stated it was something that had to be mixed. She was supposed to take a cap full and mix it with 8 ounces of liquid. Needed something to make her have a bowel movement. Only took it for two days. Was way before the vaccine. It was too strong and she stopped it. Patient took a probiotic. After that patient was given gas relief medication called: Gas Relief Extra Strength Simethicone, 125mg. Provided: V11496, MSRS 53041 REV 0417, and 883928. Patient no longer has constipation. Now it is the opposite. Now bowel movements are soft and pasty. Patient tried a stool softener that didn't work, was worthless. Was over the counter. Patient didn't take stool softeners after the COVID-19 Vaccine. All the events started from Feb2021. Outcome of the events was unknown.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/02/2021,02/01/2021,,UNK,VIT D; VIT C; LOSARTAN POTASSIUM; METOPROLOL SUCCINATE; AMLODIPINE; ASPIRIN 81,,Medical History/Concurrent Conditions: Bladder cancer (20 years ago); Blood pressure high; Coughing; Kidney cancer,,,"['Arthralgia', 'Asthenia', 'Blood pressure measurement', 'Body temperature', 'Burning sensation', 'Circumstance or information capable of leading to medication error', 'Colon cancer', 'Constipation', 'Cystitis', 'Decreased appetite', 'Diarrhoea', 'Discomfort', 'Dysuria', 'Fatigue', 'Fear', 'Feeling abnormal', 'Headache', 'Herpes zoster', 'Hyperhidrosis', 'Illness', 'Muscle spasms', 'Nervous system disorder', 'Pain in extremity', 'Post herpetic neuralgia', 'Pyrexia', 'Sneezing', 'Urinary retention', 'Weight', 'Weight decreased']",1,PFIZER\BIONTECH, 1065914,,,F,"mildly immunocompromised; This is a spontaneous report from a contactable consumer (patient's husband). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization, hydroxychloroquine sulfate (PLAQUENIL), via an unspecified route of administration from an unspecified date at unknown dose for mild rheumatoid arthritis for 15-20 years. The patient's medical history and concomitant medications were not reported. The patient experienced mildly immunocompromised on an unspecified date with outcome of unknown. The action taken in response to the event for hydroxychloroquine sulfate was not applicable. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,PLAQUENIL,,,,,['Immunodeficiency'],1,PFIZER\BIONTECH, 1065915,CA,78.0,M,"Severe abdominal cramps/abdominal cramping; Drowsiness; I had a sore shoulder and fatigue; I had a sore shoulder and fatigue; pain; anxiety; small bowel blockage/He had an intestinal blockage; His peristalsis shut down.; bowels are very irritated; He feels bruised; his guts just feel bruised; His blood pressure actually was low while in hospital; Glucose levels were very high while in hospital/when in pain and anxiety his sugar goes up; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number: EL3248) injection to upper left arm just below shoulder at approximately on 29Jan2021 10:00 at age of 78 years old at single dose for vaccination. There were no additional vaccines administered on same date of the Pfizer suspect. Relevant medical history included: for ongoing asthma and adult onset maybe 25-28 years ago. He did not have when he was a kid. He did not have allergies. Part of problem was lives in an area that had a very high allergy problem; a lot of people in that area have allergies; for sleep apnea, used CPAP machine; for diabetes from 2006 and onset date approximate. A1C is where doctors want it to be. Went through half a dozen pills and stuff for diabetes that worked for short time and stopped: Names/Lots/NDCs/Expiries: Unknown, does not have this information to provide. He was pretty good at judging carbohydrate content in meals to make adjustments to Humalog and Toujeo dosing as needed; for ongoing overweight, weight gain started after oral injectable product for diabetes stopped working, he went on different insulin product and gained 30-35 lbs. Oral injectable product: name/lot/NDC /expiry: Unknown, does not have product or this information to provide. Different insulin product: Name/Lot/NDC/Expiry: Unknown, does not have product or this information to provide; modestly high blood pressure; history of intestinal blockages (occurred quite some time ago, no continuing); had operations in the past. The adverse events (AEs) following prior vaccinations: Adverse Event: He was pretty sure he hit the floor before the needle was even out of his arm when he was administered gamma globulin vaccine which he thinks was around year 1972. The company he worked for at the time had a hepatitis break out, a couple of employees had hepatitis, so they had him receive the gamma globulin vaccine. Vaccine/Brand Name: Gamma globulin vaccine/brand name unknown, whatever it was that was available for hepatitis at the time which he thinks would have been 1972. He is pretty sure in those days they used horse serum in the gamma globulin vaccine; the doctors at the time felt pretty sure that the reaction was to the horse serum aspect of the gamma globulin vaccine. Lot/NDC/Expiry: Unknown, he does not have product or this information to provide. Vaccination Date: Thinks would have been in 1972, further details unknown. Patient's Medical History (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: All relevant information documented in formal fields of other conditions. Family Medical History Relevant to AE(s) was reported as none. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There were not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. He was supposed to have the Shingrix vaccine but decided to hold off on that until after he got the Pfizer COVID-19 Vaccine. He had the Flu vaccine around Sep2020 or Oct2020 when the senior version came out. Ongoing Concomitant medications included: losartan 100mg daily from 2019 for high blood pressure, furosemide (LASIX) 20mg daily from 2019 for high blood pressure causing some fluid buildup, fenofibrate 134mg daily for years for triglycerides, finasteride 5mg daily for years for benign prostatic hyperplasia, multivitamins, boosters of other vitamins (advised by PCP since COVID pandemic started), insulin lispro (HUMALOG) fast acting insulin taken as needed for diabetes, insulin glargine (TOUJEO) slow acting insulin taken as needed for diabetes. It was reported patient stated, he had his first dose of the Pfizer vaccine a week ago Friday 29Jan2021 at 10am. He had a sore shoulder and fatigue. At midnight he suffered abdominal cramping by 7am. He took himself to the ER and called his doctor who met him there. He had an intestinal blockage. His peristalsis shut down. He spent a couple days on an NG tube, had x-rays and imaging study, they found a small bowel blockage. It seemed very coincidental within 18 hours of the vaccine. He had them when he was younger. His physician who was an GI specialist said he had 2-3 other patients with similar reactions. He spoke to the safety team regarding this. He was due for his 2nd vaccine a few weeks. Right now his bowels were very irritated, not consistent to bowel movements. He was still on a low fiber diet. Asked if there was any evidence people are having gastrointestinal reaction. He had had blockages in the past, that was his weakness. Asked what to do about 2nd dose. He had asthma, diabetes type 2, mildly hypertensive. This consumer had his first dose of Pfizer COVID-19 Vaccine 29Jan2021 at approximately 10:00. On 29Jan2021 at about 23:30, he had went through usual drowsiness and took a nap. Around midnight 00:00 30Jan2021 he started having abdominal cramps that became very severe. He was taken to the Emergency Room where he was admitted to the hospital from 30Jan2021 until discharged home evening of 03Feb2021. Severe abdominal cramps: His peristalsis stopped, just shut down. As a result he had an intestinal blockage. He had nasogastric tube placed for 4 days. He was scheduled for surgery with a gastrointestinal surgeon who he happens to know personally. He had called that gastrointestinal surgeon before he was admitted to the hospital. The gastrointestinal surgeon thought he heard some sounds, so he delayed the surgery. That night the intestinal blockage broke up. He was discharged from the hospital before they normally would have released him to get people out as quickly as possible due to risk of contagion in hospitals. Both he and the gastrointestinal surgeon are very concerned about him having the second dose of Pfizer COVID-19 Vaccine as scheduled which is due in like 1.5 weeks. The plan at this time is for him to go on a liquid diet 2 days before the second dose so that there is nothing in him to create intestinal block. Outcomes of events: Bowel movements are irregular because just starting to get back into eating really for a few days. The first few days home he was on a soft diet of basically jell-o pudding and broths. He is on an ultra-low fiber diet right now so it's a different diet than he is accustomed to. Some of what he is eating goes right through, other times there is no bulk to come out; he kind of feels like he is constipated but it is just that there is nothing there. Doctor later this week will determine how much he can normalize his diet. Metamucil which a lot of diabetics do, doctor did not want him to take that until everything settles down. He feels bruised; his guts just feel bruised; he thinks from just the pressure there and getting in and out of the hospital bed was horrible. When he called doctor before he went to the hospital 30Jan2021, doctor told him this is coincidence, that this patient was the third that he has had who in 24 hours has had significant intestinal or bowel reaction; that he is not the first who has dealt with severe gastrointestinal problems following the Pfizer COVID-19 Vaccine. Caller clarified he has no first hand knowledge of those other patients/events/products, this was just mentioned to him by the doctor over the phone. He had no further information to provide for this report; but doctor might be able to provide further information. Relevant Tests: they did a COVID test when he was admitted to hospital 30Jan2021, gave results when he left the hospital-took them 6 days-unknown result. They did X-rays and scan of his abdomen to monitor intestinal blockage-results unknown. Blood work done but nothing remarkable there-results unknown. His blood pressure actually was low while in hospital-specific results unknown. Glucose levels were very high while in hospital which he is sure was because they had him on an IV drip that must have had glucose in it because he was not eating anything and when in pain and anxiety his sugar goes up-further details of results unknown. Patient had no further information to provide regarding testing/investigations/lab work, blood work, imaging, x-rays, etc for this report. Outcome of events were reported as unknown.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,01/29/2021,01/01/2021,,PUB,LOSARTAN; LASIX [FUROSEMIDE]; FENOFIBRATE; FINASTERIDE; HUMALOG; TOUJEO,Asthma; Benign prostatic hyperplasia; Overweight; Triglycerides,Medical History/Concurrent Conditions: Blood pressure high; Intestinal obstruction; Operation NOS; Sleep apnea (Uses CPAP machine); Type 2 diabetes mellitus,,,"['Abdominal X-ray', 'Abdominal pain', 'Anxiety', 'Arthralgia', 'Blood glucose', 'Blood glucose increased', 'Blood pressure measurement', 'Blood test', 'Fatigue', 'Feeling abnormal', 'Gastrointestinal hypomotility', 'Hypotension', 'Irritable bowel syndrome', 'Pain', 'SARS-CoV-2 test', 'Small intestinal obstruction', 'Somnolence', 'X-ray']",1,PFIZER\BIONTECH, 1065916,,,F,"Hashimoto's thyroiditis; This is a spontaneous report from a contactable physician. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced Hashimoto's thyroiditis on an unspecified date. The outcome of the event was unknown. Information on lot/batch number has been requested.; Sender's Comments: The event Hashimoto's thyroiditis is most likely an underlying/ intercurrent condition and unrelated to suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Autoimmune thyroiditis'],UNK,PFIZER\BIONTECH, 1065917,OH,86.0,F,"Stroke; This is a spontaneous report from a contactable consumer for reporter's mother. An 86-year-old female patient received first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982), via an unspecified route of administration in left arm on 25Jan2021 15:00 at single dose for COVID-19 immunisation. The patient's medical history was not reported. No concomitant medications were received. Additional Vaccines Administered on Same Date of the Pfizer Suspect: no. Prior Vaccinations (within 4 weeks): no. The patient previously took acetylsalicylic acid dipyridamole (AGGRENOX), naproxen sodium (ALEVE), ciprofloxacin, oxycodone and clopidogrel bisulfate (PLAVIX), and experienced Allergies from an unspecified date and ongoing. The patient didn't have a prescribing doctor. She got the vaccine through (hospital withheld). Patient Age at Time of Vaccination in Months or Years: 86. Vaccination Facility Type: basketball arena sponsored by (hospital withheld). Vaccine Administered at Military Facility? No. History of all previous immunization with the Pfizer vaccine considered as suspect: no. The patient experienced stroke on 27Jan2021 with outcome of unknown. The patient was hospitalized for stroke from 27Jan2021 to 01Feb2021. The patient underwent lab tests and procedures which included several blood tests and MRI (magnetic resonance imaging), both with unknown results. She also had electrodes attached to her head. Event required a visit to Emergency Room. No Physician Office visit and She is still having problems with speech.",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,01/25/2021,01/27/2021,2.0,UNK,,,,,,"['Blood test', 'Cerebrovascular accident', 'Magnetic resonance imaging']",1,PFIZER\BIONTECH, 1065918,TX,,F,"Was found by her family after collapsing on 06Jan2021 /syncope; extreme fatigue; sleepiness; headache; vomiting; weakness /notes 3/5 strength; difficulty speaking /speech disorder /vocal weakness; difficulty walking /gait disturbance; lower extremity weakness /progressive lower extremity /Muscular Weakness; hyporeflexia; Vitamin B12 Decreased; difficulty speaking /speech disorder /vocal weakness; This is a spontaneous report from a non-contactable consumer (patient). A (age: 39; unit: unknown) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot: EJ1686), intramuscularly at left arm on 04Jan2021 at single dose for covid-19 immunisation. Medical history included hypothyroidism, attention deficit hyperactivity disorder, shellfish allergy. Current illness was none. Concomitant medication included levothyroxine, lisdexamfetamine mesilate (VYVANSE). The patient previously took ceclor and experienced drug hypersensitivity, took first dose of bnt162b2 at single dose for covid-19 immunisation and experienced mild symptoms after the first vaccination, but no neurologic or vascular symptoms at that time. Patient experienced extreme fatigue and sleepiness the day following her second vaccination for Covid 19 and was found by her family after collapsing on 06Jan2021 at 05:30. Upon arousal, she experienced headache, vomiting, weakness, difficulty speaking and difficulty walking with lower extremity weakness. She was taken to urgent care and subsequently admitted for evaluation at hospital and found to have a normal chemistry, blood count, normal lumbar puncture and normal imaging of her neck and brain. Discharge summary notes 3/5 strength and hyporeflexia throughout. Patient had tele visit consult with Psychiatry and Neurology. She was subsequently to be discharged to a Facility without explanation for her sudden onset of progressive lower extremity and vocal weakness. Symptom: Asthenia, Blood Thyroid Stimulating Hormone Normal, Computerized Tomogram head, Computerized tomogram head normal, CSF cell count normal, CSF culture, CSF protein normal, fatigue, full blood count normal, gait disturbance, headache, Hyporeflexia, Lumbar Puncture Normal, Metabolic Function Test Normal, Muscular Weakness, somnolence, speech disorder, Spinal X-Ray Normal, syncope, Vitamin B12 Decreased, vomiting. Serious criteria was permanent disability and the patient was hospitalized for 4 days and had emergency room vist. Existing hospitalization was not prolonged. Lab Data on 06Jan2021 included: Normal BMP, CBC, normal TSH (thyroid stimulating hormone), low B12, Lumbar Puncture: normal, cell count and protein, culture pending, Cervical Spine X-ray: Normal, CT brain (non contrast): normal. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Yes,4.0,Yes,N,01/04/2021,01/01/2021,,UNK,LEVOTHYROXINE; VYVANSE,,Medical History/Concurrent Conditions: ADHD; Hypothyroidism; Shellfish allergy,,,"['Asthenia', 'Blood thyroid stimulating hormone', 'CSF cell count', 'CSF culture', 'CSF protein', 'Computerised tomogram head', 'Fatigue', 'Full blood count', 'Gait disturbance', 'Headache', 'Hyporeflexia', 'Investigation', 'Lumbar puncture', 'Metabolic function test', 'Muscular weakness', 'Somnolence', 'Speech disorder', 'Spinal X-ray', 'Syncope', 'Vitamin B12', 'Vitamin B12 decreased', 'Vocal cord disorder', 'Vomiting', 'X-ray']",2,PFIZER\BIONTECH,OT 1065919,,29.0,F,"miscarried; patient was pregnant at the time of the vaccine; patient was pregnant at the time of the vaccine; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration at right arm, at the age of 29-year-old, on 30Jan2021 02:00 AM, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were reported as none. The patient had no known allergies. The patient did not receive any other vaccine in four weeks or any other medications in two weeks. The patient was pregnant at the time of the vaccine 30Jan2021 and miscarried on 01Feb2021. LMP was provided as 01Jan2021, gestation period was reported as 4 weeks and due date was provided as 08Oct2021. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient did not receive any treatment in response to the event miscarried. Outcome of the event miscarried was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, a possible contributory role of suspect vaccine BNT162B2 in triggering the misarrange in this 29-year-old pregnant patient cannot be excluded. Additional information regarding relevant medical history, underlying conditions, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Abortion spontaneous', 'Off label use', 'Product use issue']",1,PFIZER\BIONTECH, 1065920,FL,85.0,M,"never woke up after arrival; Suffered with vascular dementia; Death cause: Covid/Tested positive to Covid 31Jan, tested due to increased lethargy; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient received the vaccine at nursing home/senior living facility. Medical history included dementia, hypertension, past strokes. The patient was exposed to asymptotic staff member on or prior to 25Jan2021. The patient had no known allergy. No COVID prior vaccination. Concomitant medication included lisinopril. No other vaccine was received in four weeks. The patient was tested positive to COVID on 31Jan2021, tested due to increased lethargy started from 26Jan2021. The patient suffered with vascular dementia. She was ambulatory up to 31Jan2021. The patient was sent to hospice that evening on 31Jan2021 to quarantine, never woke up after arrival. Palliative Care started 02Feb2021, the patient expired 12Feb2021. Cause of death was COVID. The patient did not receive treatment for events. The autopsy was not performed. The outcome of events ""never woke up, vascular dementia"" was unknown. Information on Lot /Batch Number has been requested.; Reported Cause(s) of Death: Death cause: Covid",Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/26/2021,4.0,SEN,LISINOPRIL,,Medical History/Concurrent Conditions: Dementia; Exposure to COVID-19 (on or prior to 25Jan2021); Hypertension; Stroke,,,"['COVID-19', 'Coma', 'SARS-CoV-2 test', 'Vascular dementia']",UNK,PFIZER\BIONTECH, 1065921,LA,87.0,F,"right middle cerebral stroke due to clot in brain; right middle cerebral stroke due to clot in brain; This is a spontaneous report from a contactable consumer or other non hcp. A 87-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9265), via an unspecified route of administration right arm single dose on 30Jan2021 15:00 for covid-19 immunisation. First dose was received on 09Jan2021 03:00 PM, right arm, lot # EK9231. Medical history included diabetes mellitus, hypertension, hyperthyroidism, glaucoma, drug allergy (to Sulfites). The patient's concomitant medications were not reported. The patient experienced right middle cerebral stroke due to clot in brain from 31Jan2021. The patient was hospitalized from 31Jan2021 to 01Feb2021. The events outcome was not recovered.",Not Reported,,Yes,Yes,1.0,Yes,N,01/30/2021,01/31/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure high; Diabetes; Drug allergy (to Sulfites); Glaucoma; Hyperthyroidism,,,"['Cerebral thrombosis', 'Cerebrovascular accident']",2,PFIZER\BIONTECH, 1065922,FL,80.0,F,"acute myeloid leukemia; This is spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 16Jan2021 at 13:00 (at the age of 80-years-old) at single dose in left arm for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 28Dec2020 at 13:00 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Workplace clinic. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has known allergies to penicillin. The patient received no concomitant medications. The patient experienced acute myeloid leukemia. Onset date of the event was reported as 16Feb2021 at 08:00. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, Life threatening illness (immediate risk of death from the event). The paitent was hospitalized for 7 days and was treated with Leukopheresis, Hydrea, Chemotherapy, Vancomycin. The patient had not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. Information about batch/lot number has been requested.",Not Reported,,Yes,Yes,7.0,Not Reported,N,01/16/2021,02/16/2021,31.0,WRK,,,Medical History/Concurrent Conditions: Penicillin allergy,,,['Acute myeloid leukaemia'],2,PFIZER\BIONTECH, 1065945,VA,,F,"it was not given in my deltoid but in the fatty portion of my anterior upper arm; arm pain; redness on anterior part of her upper arm; A spontaneous report was received from a physician concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced events like Inappropriate route of vaccination, Arthralgia and redness at anterior part of left upper arm. The patient's medical history not provided. The concomitant medications included levothyroxine sodium, Vitamin D, Calcium and Prolia. On 12th FEB 2021, the patient received their second of two planned doses of mRNA-1273 and the patient claimed that ""it was not given in my deltoid but in a fatty portion of my anterior upper arm"" for prophylaxis of COVID-19 infection. The patient experienced onset of events like Inappropriate route of vaccination, Arthralgia and redness at anterior part of left upper arm. The treatment information included paracetamol. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,UNK,THYROXINE; VITAMIN D COMPLEX; CALCIUM; PROLIA,,Medical History/Concurrent Conditions: No adverse event (No medical history provided),,,"['Incorrect route of product administration', 'Injection site erythema', 'Pain in extremity']",2,MODERNA,OT 1065946,IL,,M,"16 year old received vaccine; A spontaneous report was received from a nurse concerning a 16 years old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273). The patient's medical history not provided. The patient's concomitants not provided. On 26 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (lot #029K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. Treatment was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was resolved on 26 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (XX year old) for mRNA-1273 (lot number 029K20A) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history provided),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1065947,NM,74.0,F,"Big part of the dose dripped out from injection site; Big part of the dose dripped out from injection site; A spontaneous report was received from a Consumer concerning a 74 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a big part of the dose dripped out from injection site/injection site extravasation and underdose. The patient's medical history was not provided. No relevant concomitant medications were reported. On 13 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 32H20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 Feb 2021 during vaccination, the patient experienced the device connection issue (Big part of the dose droped out from injection site) and underdose. No Laboratory details were provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, a big part of the dose dripped out from injection site/injection site extravasation and underdose was recovered.; Reporter's Comments: This report refers to a case of underdose and injection site extravasation for mRNA-1273 (lot # 32H20A) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/13/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Injection site extravasation', 'Underdose']",1,MODERNA, 1065948,NJ,17.0,F,"17-year-old patient was given the first dose; A spontaneous report was received from a pharmacist (PharmD) concerning a 17-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patients' medical history was not provided. Concomitant product use was not provided. On 17 FEB 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection. The reporter was made aware of a 17-year-old that was given the first dose of the vaccine at his clinic. Treatment information was not provided. The action taken with mRNA-1273 in response to the event was unknown. The outcome of the event, 17-year-old patient was given the first dose, was considered recovered/resolved on 17 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 023M20A) with no associated AEs reported.; Sender's Comments: MOD-2021-015022:different patient, different reporter (from same institution) US-MODERNATX, INC.-MOD-2021-015022:different patient, same reporter",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1065949,NC,,U,"part of the vaccine went into the patients arm and part of the vaccine was excreted from the arm; A spontaneous report was received from a caregiver regarding a patient (age and gender not identified) who received Moderna's mRNA-1273 vaccine and part of the dose was excreted from the arm/accidental underdose. The patient's medical history was not provided. Concomitant medications were not provided. On 17 February 2021, the patient received the second of two planned doses of mRNA-1273 (Batch: unknown) in the arm for prophylaxis of COVID-19 infection. As the vaccine was being given, some of the dose went into the arm and part of the dose was excreted from the arm. Treatment information was not provided. Action taken with mRNA-1273 was not applicable. The outcome of the event, part of the dose being excreted from the arm, was considered resolved.; Reporter's Comments: This report refers to a case of accidental underdose for mRNA-1273, with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical History not provided),,,['Accidental underdose'],2,MODERNA,OT 1065950,CT,72.0,F,"needle separated from the syringe and only partial dose was administered; only partial dose was administered; A spontaneous report was received from a nurse concerning a 72-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced needle separated from the syringe and only partial dose was administered (device connection issue) (underdose). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 17 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 023M20A] intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 17 Feb 2021, when the vaccinator (nurse) pushed the plunger down, the needle separated from the syringe and only partial dose was administered to the patient. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events needle separated from the syringe and only partial dose was administered was resolved on 17 Feb 2021.; Reporter's Comments: This report refers to a case of Syringe connection issue and Vaccine underdose for mRNA-1273, lot # 023M20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Device connection issue', 'Underdose']",1,MODERNA,OT 1065951,NM,74.0,F,"Vaccine liquid spilled from syringe during administration; Vaccine liquid spilled from syringe during administration; A spontaneous report was received from a pharmacist concerning a 74-years-old, female patient who experienced vaccine liquid spilled from syringe during administration. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 17 Feb 2021, prior to the onset of the symptoms, the patient received their planned dose of mRNA-1273 [Lot number 023M20A] for prophylaxis of COVID-19 infection. On 17 Feb 2021, the pharmacist reported that some of the vaccine spilled from the syringe during administration. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The event vaccine liquid spilled from syringe during administration was considered recovered/resolved on 17 Feb 2021.; Reporter's Comments: This report refers to a case of Vaccine underdose and syringe connection issues for mRNA-1273 [Lot number 023M20A] with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Device connection issue', 'Underdose']",UNK,MODERNA,OT 1065952,NJ,,F,"Vaccine was given to 16 year old; A spontaneous report was received from a pharmacist concerning a 16-year-old, female patient who experienced: Vaccine was given to 16-year-old. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 17FEB2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection. Director of pharmacy reported that the first dose of the vaccine was given to a 16 year old patient and wanted to see if they could register for clinical trials. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the event was unknown. The event, vaccine was given to 16-year-old was considered recovered/resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273. There were no reported adverse events associated with this case.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-014927:different patient, same reporter",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical History),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1065953,FL,39.0,M,"is it safe to receive an expired vaccine; A spontaneous report was received from a Consumer concerning a 39 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported that the patient received 39 Years-old male patient who received The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (batch: 025J20A) intramuscularly for prophylaxis of COVID-19 infection. On 17 Feb 2021, the consumer called customer care stating that he received the first dose of vaccine on 27 Jan,2021 but on the card that he received the expiration date stated 22 Jan 2021. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. At the time of this report, the outcome of the event (receive an expired vaccine) was unknown.; Reporter's Comments: This report refers to a 39 Years-old male patient who received 39 Years-old male patient who received an expired vaccine. This case of expired product use has no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse drug reaction (No medical history reported),,,['Expired product administered'],1,MODERNA,OT 1065954,CO,,U,"5 doses were withdrawn from a vial punctured more than 6 hours ago; A spontaneous report ( was received from a healthcare professional, concerning a unknown patient of unknown age and gender, unknow race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced 5 doses were withdrawn from a vial punctured more than 6 hours ago (expired product administered) and error was made and 5 doses were given that were not valid. The patient's medical history was not reported. No Relevant concomitant medications were reported like On an unknown date, prior to the onset of the events, the patient received their unknown planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly for the prophylaxis of COVID-19 infection. On unknown date, the health care professional mentioned and reported that an error was made, and 5 doses were given that were not valid since doses were withdrawn from a vial punctured more than six hours ago. The vial was refrigerated. Five patients received an invalid dose and there was an error made for those five patients. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, 5 doses were withdrawn from a vial punctured more than 6 hours ago and error was made and 5 doses were given that were not valid, were reported as recovered.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot/batch: unknown) with no associated AEs. The expired product was administered to five patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Expired product administered'],UNK,MODERNA,OT 1065955,WI,,M,"portion of the medication came out of the syringe; VACCINE UNDERDOSE; A spontaneous report received from a health care professional concerning a 37 years old male patient who received Moderna's COVID-19 (mRNA-1273)vaccine and experienced device connection issue and vaccination under dose. The medical history of the patient was not provided. No relevant concomitant medication were provided. On 17-feb-2021 prior to onset of the event, the patient received the first of two planned doses of COVID-19 (mRNA-1273)vaccine (batch no.023M20A) via unknown route in left non-dominant arm for prophylaxis of COVID-19 infection. The pharmacist reported that a portion of the medication came out of the syringe. Action taken in response to (mRNA-1273) vaccine event was not reported. The outcome of event was not reported.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273. There were no reported adverse events associated with this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Device connection issue', 'Underdose']",1,MODERNA, 1065970,IL,35.0,M,"I tested positive for covid on ~11/26. Relatively mild case with mild fatigue and lost of taste and smell. Possibly some worsening exercise tolerance ~3-4 weeks after initial onset date. I'm not sure if it was deconditioning vs lingering covid effects. No side effects from first covid vaccine minus a sore arm. After second dose some mild fatigue ~2 days. Then 12 days after second dose significant more fatigue and in the next few days chills at night and tachycardia with pulse in 120s at rest. No fever, pain, sob, swelling or other symptoms. Presented to immediate care on 2/27 predominantly for the tachycardia. Was referred to the ED. Discharged on 3/1 on metoprolol with possible diagnosis of viral myocarditis.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/12/2021,02/24/2021,12.0,UNK,None,None,None (scoliosis),,Nkda,"['Atrioventricular block', 'Brain natriuretic peptide increased', 'Chest X-ray normal', 'Chills', 'Computerised tomogram thorax normal', 'Echocardiogram normal', 'Electrocardiogram abnormal', 'Fatigue', 'Magnetic resonance imaging heart', 'Pain in extremity', 'Tachycardia', 'Troponin increased']",2,PFIZER\BIONTECH,IM 1065976,AL,68.0,M,"Pulmonary Embolus, hospitalized. Released by hospital 2 days after event. Blood Thinners and pain medication.",Not Reported,,Yes,Yes,2.0,Not Reported,N,02/18/2021,02/25/2021,7.0,PUB,None,None,None,,None,['Pulmonary embolism'],2,MODERNA,IM 1065979,TX,63.0,M,No known side effects; postmortem Covid-19 test negative Date of death: 02/12/2021,Yes,,Not Reported,Not Reported,,Not Reported,,12/01/2020,01/20/2021,50.0,UNK,,,,,,"['Death', 'SARS-CoV-2 test negative']",2,MODERNA,UN 1065980,FL,66.0,M,"Presented to the ER 1 day after receiving the second dose of Moderna vaccine with truncal ataxia, vertigo, and dizziness. Patient later became aphasic in the ER. Patient also noted to be febrile, hypotensive, with elevated lactic acid. Patient discharged on day 3 of admission per neurology clearance.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/26/2021,02/26/2021,0.0,PVT,"Tylenol 500 mg PO q6h PRN mild pain, Eliquis 5 mg PO BID, glipizide 10 mg PO BID, olmesartan 20 mg PO daily",No known prior acute illness one month prior and at time of vaccination,"PMH: Atrial fibrillation on Eliquis, diabetes mellitus, GERD, hypertension",,NKDA,"['Aphasia', 'Ataxia', 'Blood culture negative', 'Blood lactic acid', 'Blood lactic acid increased', 'Chest X-ray abnormal', 'Dizziness', 'Hypotension', 'Magnetic resonance imaging head normal', 'Microbiology test', 'Pulmonary congestion', 'Pyrexia', 'Urine analysis normal', 'Vertigo']",2,MODERNA,SC 1065989,NE,76.0,M,"Pt developed severe fevers, myalgias, headache, inability to take PO day after vaccine, developed significant AKI and required hospitalization - overnight observation. Was hospitalized 2/23 - 2/24 and had resolution of symptoms, improvement in AKI and was stable for discharge home.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/21/2021,02/22/2021,1.0,PUB,"carvedilol, allopurinol, aspirin, atorvastatin, clopidogrel, cholecalciferol, fluticasone-salmeterol inhaler, furosemide, metolazone, montelukast, omeprazole, potassium chloride, pregabalin",CKD had kidney biopsy on 2/16/21 Patient had severe COVID19 in 11/2020 requiring hospitalization,"HTN, CKDIII, HLD, CAD s/p CABG, AAA, asthma, obesity, OSA on CPAP",,no known allergies,"['Acute kidney injury', 'Blood creatinine increased', 'Feeding disorder', 'Headache', 'Hypophagia', 'Myalgia', 'Pyrexia', 'Troponin increased']",UNK,MODERNA, 1066002,,83.0,F,"Received 1st dose of covid vaccine on 2/3/21, 2nd dose on 2/24/21, admitted to hospital on 3/1/21 with acute respiratory failure/COPD exacerbation, tested negative for COVID, afebrile, vitals wnl, no signs for bacterial/viral infection.",Not Reported,,Not Reported,Yes,,Not Reported,,02/24/2021,03/01/2021,5.0,UNK,,,,,,"['Acute respiratory failure', 'Chronic obstructive pulmonary disease', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH, 1066027,MN,33.0,F,"I was 34 weeks, 5 days pregnant at the time of vaccination (due date 3/26/2021). The next day at 10pm my water broke and I went into early labor. I had my baby on Friday in the early morning. Prior to this, I had no risks or warning signs of early labor (e.g. preeclampsia, gestational diabetes, etc) and was generally following a routine pregnancy path.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/17/2021,02/18/2021,1.0,PUB,"Prenatal vitamin, iron supplement",None,None,,Sensitivity to penicillin,"['Blood test', 'Exposure during pregnancy', 'Laboratory test', 'Premature delivery', 'Premature labour', 'Urine analysis']",1,MODERNA,SYR 1066039,NC,27.0,M,"Per patient statement - 30 minutes after reciving vaccine patient reports that he started to feel congested. AT that point the thought it was allergies from the day before. His wife dropped him off aat work. He had someone take him to healthcare center. Was given Epinephirne at 1045am. He was discarged by ED, with Epinephrine Rx. At 230 his wife injected him with another epinephrine due to congestion and diffculty breathing, speaking, it felt like his througfht was getting tight. EMS gave himanother dose of Epineprine and was taken to ER again. 6pm on February 25 nebulizer , had complaints of difficulty breathing speaking was taken to healthcare center and admitted. Discharged on February 26, 2020 Saturday 730 Difficulty breathing, wheezing, speaking could not swallow Horse, abdmen pain, lethargic,",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/24/2021,02/24/2021,0.0,PUB,Breo Ellipta once daily Spiriva once a day Amlodipine once a day Buspirone as needed,No Decmber 2020 Positive for COVID,High Blood Pressure Asthma Depression,,Shellfish,"['Abdominal pain', 'Chest X-ray', 'Computerised tomogram neck', 'Dysphagia', 'Dysphonia', 'Dyspnoea', 'Lethargy', 'Respiratory tract congestion', 'Speech disorder', 'Throat tightness', 'Wheezing']",1,MODERNA,IM 1066092,AL,77.0,F,"patient presents to the ER complaining of nausea, vomiting, diarrhea on 3/1 @ 0134 AM. She states the symptoms occurred gradually on 2/28. She is admitted to the hospital with a diagnosis of noninfective gastroenteritis. She states the symptoms are aggravated by food and alleviated by remaining still. She states she has not experienced similar symptoms in the past. The patient and the hospitalist, Dr., attributes her symptoms to the Moderna Vaccine. Patient is given IV fluids (NS), protonix, and Zofran for her symtpoms.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/25/2021,02/28/2021,3.0,PVT,"ferrous sulfate, amaryl, ziac, hydralazine, Prilosec, Zestril, pravastatin, methotrexate, vitamin D, zinc,",,"acid reflux, diabetes, dyslipidemia, essential hypertension, rheumatoid arthritis",,penicillin,"['Diarrhoea', 'Gastrointestinal inflammation', 'Nausea', 'Vomiting']",2,MODERNA,IM 1066093,TX,63.0,M,"No known side effects; however, on 1/20 the decedent suffered lethargy. On 2/12/2021, the decedent had a possible seizure and was transported to emergency department where shortly after arrival, he was pronounced dead.",Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,02/02/2021,34.0,OTH,"Atorvastatin, Suboxone, aspirin, finasteride, Guaiefenesin, imodium, lisinopril, metoprolol, pantoprazole, Prostat sugar free liquid protein (pollen extracts), solifenacin, tamsulosin, Humulin","Hypertension, diabetes mellitus, hyperlipidemia, chronic systolic heart failure, paroxysmal atrial fibrillation, low back pain with intermittent radiculopathic symptoms, history of ruptured gastrointestinal ulcer in 2018 with resultant internal bleeding and cerebrovascular disease with right-sided neurologic deficit, neurogenic bladder with indwelling catheter, Covid-19 positive (7/2020) with subsequent negative tests 12/2020, 01/2021, and 2/2021",same as other illnesses,,Unknown,"['Death', 'Lethargy', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,UN 1066107,PA,80.0,U,death,Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,02/22/2021,32.0,SEN,,,,,,['Death'],2,PFIZER\BIONTECH,IM 1066111,CO,49.0,M,"Decreased sensation from chest/abdomen through lower extremities, diminished strength and mobility of left side. Symptoms started approximately 24 hours after receiving the vaccine starting with decreased sensation in the lower extremities . 02/14/2021 I started experiencing weakness on the left side. 02/16/2021 symptoms progressed to limited movement on the left side preventing ability perform normal daily functions and digestion was effected.",Not Reported,,Not Reported,Yes,24.0,Yes,N,02/11/2021,02/12/2021,1.0,PVT,"Multivitamin, Vitamin D",None,None,,None,"['Asthenia', 'Dyspepsia', 'Hemiparesis', 'Loss of personal independence in daily activities', 'Mobility decreased', 'Sensory loss']",2,PFIZER\BIONTECH,IM 1066115,MA,63.0,F,"Moderna COVID-19 Vaccine EUA, My legs were getting sore and tired at work. I sat down to tie my shoe and noted Pitting + 3 or 4 edema to BIL Calves. Redness , warmth in a few areas. R leg 1"" larger than L. Then I mentioned it to another nurse and she said it could be side affect of Norvasc. I spoke with my PA about it on 2/12 she D'C'd Norvasc and perscribed Nefidepine 30 mg ER. I have not taken it yet I am monitoring my BP and it is WNL. The edema less in calves however continues in ankles. I have gotten MULTIPLE broken capillaries all over my legs. Long short it has to be a reaction to vaccine. And it continues almost 2 months after injection. I can't wear most of my socks. It is BAD.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/08/2021,01/22/2021,14.0,WRK,"norvasc,fosamax, Armour thyroid",none,"HTN, Osteoporosis, Hypothyroid",,NKDA NK Food Allergies,"['Capillary fragility', 'Erythema', 'Fatigue', 'Feeling hot', 'Impaired work ability', 'Oedema', 'Pain in extremity', 'Peripheral swelling', 'Skin warm']",1,MODERNA,IM 1066118,PA,46.0,M,"Patient had an unwitnessed cardiac arrest while outside walking his dog. AED in the field initially advised shock and was shocked 3 times without effect. At the time EMS ALS arrived, patient was in PEA arrest. He was transferred to Hospital with CPR in progress. Time of death called at 1857.",Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,PVT,Atorvastatin Dulaglutide Glipizide Loratadine Losartan Metformin,None,Type 2 Diabetes Hypertriglyceridemia Hypertension Recurrent pancreatitis Obesity Nicotine dependence,,"Apple, cherry, pear, pollen - throat swelling and itching","['Cardiac arrest', 'Cardioversion', 'Death', 'Pulseless electrical activity', 'Resuscitation', 'Shock']",UNK,PFIZER\BIONTECH,IM 1066123,MA,52.0,F,Within minutes of getting the vaccine I was on the floor. I was taken to the hospital and am still here. I can't feel anything below my knees and have weekness in my hands. I can't walk and have difficulty moving my legs. Doctors are saying that they don't know if I will ever walk again.,Not Reported,,Not Reported,Yes,37.0,Yes,N,01/01/2021,01/02/2021,1.0,PVT,None,None,None,,None,"['Gait inability', 'Mobility decreased', 'Muscular weakness', 'Paraesthesia', 'Sensory loss']",1,PFIZER\BIONTECH,SYR 1066126,PA,66.0,F,death,Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/26/2021,5.0,SEN,,,,,,['Death'],2,PFIZER\BIONTECH,IM 1066141,OR,57.0,F,"muscle weakness, stiffness, swelling, poor coordination, and muscle atrophy in the hands, shoulders and hip girdle muscles",Not Reported,,Not Reported,Not Reported,,Yes,N,02/02/2021,02/16/2021,14.0,PUB,levothyroxine 75 mcg liothyronine 5 mcg valcyclovir 500 mg estradiol 2 mg prometrium 100 mg,none,hypothyroidism herpes simplex menopause neural foraminal stenosis lumbar spine,TDAP 1996 left arm swelling and scaring fibroma,sulfa terbenafine lamictal,"['Biopsy peripheral nerve', 'Blood test', 'Coordination abnormal', 'Muscle atrophy', 'Muscular weakness', 'Musculoskeletal stiffness', 'Neuralgic amyotrophy', 'Neurological examination', 'Swelling']",1,MODERNA,IM 1066166,NE,80.0,M,"Patient is an 80-year-old male that is admitted for observation status for recent TIA symptoms and bradycardia. He was seen in the emergency room this morning at approximately for complaints of posterior head and neck pressure, right arm numbness and tingling as well as a mild blurry vision in his right eye. Patient states that the symptoms from the right arm and eye blurriness lasted less than 1 hour. And has completely resolved at this time. Patient states that he still does have some posterior neck tightness. But most of this is on the left side at this point. Patient denies any increase in physical activity that he could attribute to the onset of the neck pain. Patient states that it does feel tight when he turns his head from side to side. Patient states that he no longer has a headache. He does have a history of a possible mini stroke approximately 10 years ago. He has had no other recent cardiac problems, or any other strokelike symptoms since that time. Patient takes medications for his cholesterol and a baby aspirin daily. Patient is fairly active and continues to drive a semi-5 days a week. TIA Neurochecks every 4 hours Carotid Dopplers 3/2 Bradycardia Echocardiogram 3/2 Last echo 1/4/2019, EF 60% Discharged home 3/2/21.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,02/12/2021,03/01/2021,17.0,PVT,"aspirin, fish oil, simvastatin",None,Hyperlipidemia,,NKA,"['Alanine aminotransferase normal', 'Anion gap decreased', 'Aspartate aminotransferase normal', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bilirubin normal', 'Blood calcium decreased', 'Blood chloride normal', 'Blood creatine phosphokinase MB increased', 'Blood creatine phosphokinase normal', 'Blood creatinine normal', 'Blood glucose increased', 'Blood magnesium normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea normal', 'Bradycardia', 'C-reactive protein normal', 'Carbon dioxide normal', 'Echocardiogram', 'Globulin', 'Glomerular filtration rate normal', 'Head discomfort', 'Hypoaesthesia', 'Muscle tightness', 'Musculoskeletal discomfort', 'Myoglobin blood', 'Neck pain', 'Neurological symptom', 'Paraesthesia', 'Protein total normal', 'Transient ischaemic attack', 'Troponin I increased', 'Ultrasound Doppler', 'Vision blurred']",1,MODERNA,SYR 1066178,FL,90.0,M,Caller is nephew of patient. Patient was admitted to Hospital on 2/15/21 with Covid like symptoms and decreased O2 sat. He tested positive for Covid 2/15/21. Treated with Remdesivir. Patient status continued to decline and he passed away in hospital 2/22/21 0612.,Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/15/2021,5.0,UNK,,,"CAD, HTN, Basal Cell CA, cancerous appendix removed 1 month ago",,,"['COVID-19', 'Death', 'General physical health deterioration', 'Oxygen saturation decreased', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 1066199,NE,80.0,M,"Patient had gotten up to the bathroom and collapsed in the hallway after using the restroom. Patient was unresponsive upon EMS arrival with vomitus coming out of the mouth per the report when they rolled patient over onto his side the emesis was pouring out of his mouth. ER course: Examination. Epinephrine 1 mg IO x4 CBC, CMP, cardiac panel MDM: 1447 patient arrival, per EMS report patient had been sick and vomiting all morning. Bradycardia noted at arrival with rates in the 30s, CPR was initiated patient had received 3 rounds of epi prior to arrival. 1450 CPR continues via the Lucas device, 1 mg epinephrine given IV push 1451 CPR pause rhythm check. CPR resumes 1453 CPR paused for rhythm check. No central pulses, CPR resumed, glucose of 99 per fingerstick 1454 King tube removed. Oral airway placed respirations by BVM. 1 mg epinephrine IV push 1455 CPR pause for both pulse and rhythm check. No central pulses noted. CPR resumes via Lucas 1456 pupils are fixed and dilated bilaterally 1457 CPR pause for pulse and rhythm check. No central pulses noted. CPR resumed via Lucas. 1 mg epinephrine IV push 1459 warm blankets applied. CPR pause for pulse and rhythm check. No central pulses noted. CPR resumed 1501 CPR pause for pulse and rhythm check. No central pulses. CPR resumes 1502 1 mg epinephrine given IV push 1503 CPR pause for pulse and rhythm check. No central pulses noted. CPR resumed via the Lucas device 1506 resuscitation is ceased at this time. Time of death recorded at 1506",Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,N,02/08/2021,03/01/2021,21.0,PVT,"Multiple Vitamins(multivitamin) tablet 1 tablet by mouth once a day aspirin(aspirin) 81 mg tablet,delayed release (DR/EC) 1 tablet once a day ibuprofen(ibuprofen) 200 mg capsule 1-2 capsule by mouth at bedtime as needed carvedilol(carvedi",Per EMS report patient had been having diarrhea and vomiting for the last 3 to 4 days.,Hyperlipidemia (disorder) Generalized osteoarthritis (disorder) Hypothyroidism (disorder) Tinnitus (finding) Benign essential hypertension (disorder),,LIPITOR,"['Alanine aminotransferase increased', 'Anion gap increased', 'Aspartate aminotransferase increased', 'Blood albumin decreased', 'Blood alkaline phosphatase normal', 'Blood bilirubin increased', 'Blood calcium increased', 'Blood chloride normal', 'Blood creatine phosphokinase MB', 'Blood creatine phosphokinase MB decreased', 'Blood creatine phosphokinase increased', 'Blood glucose increased', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea increased', 'Bradycardia', 'Carbon dioxide decreased', 'Death', 'Epinephrine', 'Full blood count', 'Globulins increased', 'Glomerular filtration rate decreased', 'Laboratory test', 'Malaise', 'Metabolic function test', 'Mydriasis', 'Myocardial necrosis marker', 'Myoglobin blood increased', 'Protein total normal', 'Pulse absent', 'Pupil fixed', 'Resuscitation', 'Syncope', 'Troponin I increased', 'Unresponsive to stimuli', 'Vomiting']",2,MODERNA,IM 1066209,MA,87.0,M,"[COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): He presented 10 days after first COVID-19 Vaccine with Progressive neurological deficits with bulbar manifestations - dysarthria, dysphagia and bilateral arm weakness and incoordiantion, worse on right. MRI brain was negative for acute stroke and MRI cervical, showed degenerative changes. Transferred from community hospital to tertiary center where the diagnosis was made of AIDP. He was intubated at that time in Neuro ICU. Given Steroids and IVIG but no improvement and was either will need to have Trach and PEG vs CMP and family honored the patient's wishes and made him CMO. signs of severe demyelination and AIDP was diagnosed.",Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,,12/30/2020,01/18/2021,19.0,UNK,,,"Hx of CLL and possible CSF involvement, also hx of Rheumatoid arthritis.",,,"['Aphasia', 'Bulbar palsy', 'Cognitive disorder', 'Coordination abnormal', 'Death', 'Demyelination', 'Dysarthria', 'Dysphagia', 'Electromyogram abnormal', 'Endotracheal intubation', 'Guillain-Barre syndrome', 'Immunoglobulin therapy', 'Intensive care', 'Magnetic resonance imaging brain normal', 'Magnetic resonance imaging neck', 'Muscular weakness', 'Nervous system disorder', 'Progressive bulbar palsy', 'Spinal osteoarthritis']",UNK,PFIZER\BIONTECH, 1066231,CA,,U,"vaccine administered to 17.5 year old; A spontaneous report was received from a Healthcare Professional, concerning a patient of 17.5-year-old and was administered the Moderna vaccine (mRNA-1273). The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection. On an unknown date, the pharmacy accidentally vaccinated a 17.5-year-old patient with the first dose of Moderna COVID vaccine. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of event, vaccine administered to 17.5-year-old was considered as resolved on an unknown date.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17.5 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1066232,CT,,M,"the syringe came off and the needle stayed in his arm, the serum was everywhere.; A spontaneous report was received from a Healthcare Professional concerning a male patient, of approximately 50-60 years of age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination device connection issue. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot/batch: if reported or unknown) for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient experienced as reported, the syringe came off and the needle stayed in his arm, the serum was everywhere. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event(s) (The syringe came off and the needle stayed in his arm, the serum was everywhere) was unknown.; Reporter's Comments: This report refers to a case of Vaccine underdose and syringe connection issue for mRNA-1273 with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,02/11/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Underdose'],1,MODERNA,OT 1066233,SD,,U,"Younger than 18 patient received the shot; A spontaneous report was received from a pharmacist concerning a patient who experienced the following: younger than 18 patient received the shot. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, prior to the onset of the event, the patient received a dose of mRNA-1273 (Batch number not provided, not specified if 1st or 2nd dose) for prophylaxis of COVID-19 infection. On an unknown date, the patient was younger than 18 and received vaccination. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event younger than 18 patient received the shot was resolved.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273 (Batch number not provided, not specified if 1st or 2nd dose) with no associated AEs.; Sender's Comments: MOD21-032350:Same reporter",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],UNK,MODERNA,OT 1066234,WA,80.0,M,"Vaccine dripping out on arm; Vaccine dripping out on arm; A spontaneous report was received from a consumer concerning an 80-years-old, male patient who experienced vaccine dripping out on arm. The patient's medical history included chronic obstructive pulmonary disease (COPD) and diabetes. Concomitant product use was not provided by the reporter. On 17 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 [Lot number 0bIL20A] intramuscularly for prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient experienced vaccine dripping out and going down his arm. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The event vaccine dripping out on arm was considered recovered/resolved on 17 Feb 2021.; Reporter's Comments: This report refers to a case of vaccine underdose and exposure via skin for mRNA-1273 [Lot number 0bIL20A] with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,UNK,,COPD; Diabetes,,,,"['Exposure via skin contact', 'Underdose']",2,MODERNA,OT 1066235,SD,17.0,F,"17 year old received moderna vaccine; A spontaneous report was received from a pharmacist regarding a 17-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) with inappropriate age at vaccination administration. The patient's medical history was not included. Concomitant medications were not provided. On 16 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, it was noticed after the vaccine was given that the patient was not the correct age to receive the vaccine. Her age is reported as 17. No side effects were reported and treatment was not given. Action taken with mRNA-1273 was not reported. The outcome of the event, receiving the vaccine at an inappropriate age, was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273. There were no reported adverse events associated with this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical history not provided),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1066236,CT,,F,"Patient was given 0.3 ml dose; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced accidental underdose of vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On an unknown date, the patient was given 0.3 ml dose of the COVID-19 vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. At the time of this report, the outcome of the event (accidental underdose) was recovered/resolved The reporter did not assess causality for the reported event.; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious unexpected events of Accidental underdose with mRNA-1273 (lot # unknown) without associated adverse events. The patient was given 0.3 ml dose of the COVID-19 vaccine. The events occurred the same day as the first dose of mRNA-1273. Event reported as resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Accidental underdose'],1,MODERNA,OT 1066237,,16.0,M,"vaccine administered at 16 years old; A spontaneous report was received from a Consumer concerning a 17 year-old male patient who experienced vaccine administered at 16 years old/ MedDRA PT: product administered to patient of inappropriate age. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received the first of two planned doses of mRNA-1273 (batch: unknown) for prophylaxis of COVID-19 infection. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event, vaccine administered at 16 years old was resolved on an unknown date.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273 (batch: unknown) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1066238,,,F,"Uveitis; pain around my left eye and the eye ball; eye ball was also red; Sore arm; A spontaneous report (United States) was received from a consumer who was also a 69-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm, pain around her left eye and eye ball, eye red, and uveitis. The patient's medical history was not reported. Products known to have been used by the patient, within two weeks prior to the event, included lisinopril, escitalopram oxalate and omeprazole. On 14 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly in the left arm shoulder deltoid muscle for prophylaxis of COVID-19 infection. On date 16 Feb 2021, the patient had a sore arm, pain around her left eye and eye ball and eye was red. The patient experienced a condition called uveitis. Treatment for the event included Pred-Forte eye drops. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events is unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/14/2021,02/16/2021,2.0,UNK,LISINOPRIL; LEXAPRO; OMEPRAZOLE,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Eye pain', 'Ocular hyperaemia', 'Uveitis', 'Vaccination site pain']",1,MODERNA,OT 1066239,OH,71.0,M,"severe COPD; could not breathe; chest pressure; pressure in the neck; rapid heartrate; premature ventricular contractions, extra heart beat; face swollen a little; A spontaneous report was received from a consumer concerning a 71-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced severe COPD, could not breathe, had chest pressure, pressure in the neck, rapid heartrate (have extra heartbeat), premature ventricular contractions and swelling in face. No prior medical history and concomitant medications were reported. On 11 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The patient experienced the events like severe COPD, could not breathe, had chest pressure, pressure in the neck, rapid heartrate (have extra heartbeat), premature ventricular contractions and swelling in face on 12 Feb 2021. The reported case is serious as the events, severe COPD, could not breathe, had chest pressure, pressure in the neck, rapid heartrate (have extra heartbeat), premature ventricular contractions and swelling in face lead to hospitalization and resulted in prolonged hospitalization. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were considered not resolved and the patient is still in.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/11/2021,02/12/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No prior medical history reported.),,,"['Chest discomfort', 'Chronic obstructive pulmonary disease', 'Dyspnoea', 'Heart rate increased', 'Musculoskeletal discomfort', 'Swelling face', 'Ventricular extrasystoles']",1,MODERNA,OT 1066240,IN,,F,"burning in arm at injection site; numbness in arm at injection site; Hard to swallow; saliva was coming out of Lips; numbness spread from shoulder to neck to back of head, around front of head down to face and to lip; A spontaneous report was received from a reporter(Health care professional) concerning 51 year old, female patient , who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced burning and numbness in arm at the site of injection, numbness spread from shoulder to neck to back of head, around front of head down to face and to lip, drooling, dysphagia. The patient medical history was not provided. The relevant concomitant medications were also not provided. On 31-DEC-2020, prior to the consent of the events, the patients received one dose of mRNA-1273(batch number: 026L20A) through intramuscularly in the left arm for prophylaxis of COVID-19 injection. On 31-DEC2021, the patient experienced injection site pain, burning, numbness in arm, shoulder, neck, back of the head, lip and face, hard to swallow and drooling. The patient had undergone CT scan of head, MRI of the brain with contrast, Chest X-ray ang EKG as well as lab work. She was referred to a neurologist and has an April appointment. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/31/2020,12/31/2020,0.0,PVT,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Drooling', 'Dysphagia', 'Hypoaesthesia', 'Injection site hypoaesthesia', 'Injection site pain']",1,MODERNA,OT 1066244,FL,56.0,M,"Bell Palsy, Rt face weakness, Adult. Treating with Valacyclovir HCL 1gm tab #21/21, 1 tab for 7 days; and Prednisone 20mg tab, 3 tabs per day for 7 days.",Not Reported,,Not Reported,Yes,2.0,Yes,N,02/13/2021,02/28/2021,15.0,PVT,"Centrum for Adults multivitamin, fish oil gel cap. Acyclovir 200mg, Atorvastatin 10mg.",None,"Sleep Apnea severe, Spondylolisthesis.",,None,"[""Bell's palsy"", 'Blood test', 'Computerised tomogram', 'Facial paresis', 'Magnetic resonance imaging', 'Scan with contrast', 'Urine analysis']",1,PFIZER\BIONTECH,SYR 1066274,PA,46.0,F,death,Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/23/2021,2.0,UNK,,,,,,['Death'],2,PFIZER\BIONTECH,IM 1066289,PA,88.0,U,death,Yes,02/08/2021,Not Reported,Not Reported,,Not Reported,,01/21/2021,02/08/2021,18.0,UNK,,,,,,['Death'],2,PFIZER\BIONTECH,IM 1066291,LA,80.0,F,Patient administered vaccine on 1/14/21 with no reactions noted after 15 minutes. Patient seen for wellness visit on 1/20/21 with no complaints regarding vaccine. Patient died on 1/30/21,Yes,01/30/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,,,OTH,"nitroglycerin, asa,crestor,lantus,gabapentin,clopidogrel isosorbide, metformin,metoprolol, furosemide, ramipril, pantoprazole, albuterol, ondansetron, methocarbamol, norco, diclofenac Patient was given influenza vaccine by an outside provid",none,"Type 2 diabetes, heart failure, hyperlipidemia, claudication, left hip and knee pain",,"Aspirin, pneumococccal vaccine",['Death'],1,MODERNA,IM 1066305,CA,66.0,M,Patient has gastric cancer that was in remission. Within 48 hours of receiving the vaccine he noted abdominal discomfort and swelling which progressively increased and led to a diagnosis of malignant ascites within a week of the vaccine.,Not Reported,,Yes,Yes,14.0,Not Reported,N,01/25/2021,01/27/2021,2.0,PHM,Mineral Oil 30ml twice daily Bariatric Fusion Chewable Multivitamins 2 twice daily Colace 100mg twice daily Finasteride 5mg daily Tamulosen 4mg daily,Gastric Cancer Benign prostatic hypertrophy,BPH,,None,"['Abdominal discomfort', 'Abdominal distension', 'Condition aggravated', 'Malignant ascites', 'Paracentesis', 'Peritoneal fluid analysis abnormal']",1,MODERNA,SYR 1066307,LA,95.0,F,"Patient is not a patient of our clinic. When called to confirm appointment for second dose, we were notified patient was deceased.",Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,,01/27/2021,,,OTH,unknown,unknown,unknown,,unknown,['Death'],1,PFIZER\BIONTECH,IM 1066322,MI,83.0,M,"Patient was vaccinated approx 9a. Later that evening, patient was having trouble breathing so they called son who lives down the road to come, 20 mins after the call the patient has passed. Per medical examiner, pt died due to possible PE, MI, or his aortic aneurysm ruptured.",Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/15/2021,0.0,PVT,unknown,multiple heart issues,multiple heart issues,,unknown,"['Aortic aneurysm rupture', 'Death', 'Dyspnoea']",2,PFIZER\BIONTECH,IM 1066332,PA,66.0,U,death,Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/25/2021,4.0,UNK,,,,,,['Death'],2,PFIZER\BIONTECH,IM 1066344,LA,88.0,M,"This not a patient of our clinic. When called to confirm his second dose vaccine, is when we learned patient is deceased. Unable to reach anyone regarding date of death.",Yes,,Not Reported,Not Reported,,Not Reported,,01/28/2021,,,OTH,unknown,unknow,unknown,,unknown,['Death'],1,PFIZER\BIONTECH,IM 1066358,FL,70.0,M,"Three days after receiving dose #1 of COVID-19 vaccine, patient had a first potential seizure event. Patient reports waking up with LLE pain and weakness and a bite mark on the right side of is tongue. He also noticed he had urinated on himself (a small amount). Pt presented to ED on 1/22 where seizure work-up performed. MRI brain showed ""non-specific gliosis along the L cerebellar hemisphere along with chronic BG infarcts."" Unremarkable EEG. Started on levetiracetam 500 mg BID at discharge and continues to follow with outpatient neurology.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/16/2021,01/19/2021,3.0,PVT,"Losartan 25 mg po daily, aspirin 81 mg po daily, atorvastatin 20 mg po daily, cyanocobalamin 5,000 mg po daily, diltiazem 60 mg po BID, insulin glargine 44 units sc qhs, levothyroxine 88 mcg po daily, metformin 1000mg BID, insulin aspart 10",None documented,"type 2 DM, HTN, BPH, OSA on CPAP, hypothyroidism, diabetic neuropathy, chronic GERD",,None documented,"['Asthenia', 'Basal ganglia infarction', 'Electroencephalogram normal', 'Gliosis', 'Magnetic resonance imaging head abnormal', 'Pain in extremity', 'Seizure', 'Tongue biting', 'Urinary incontinence']",1,PFIZER\BIONTECH,IM 1066367,OH,79.0,F,"Chills, shortness of breath, body aches",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/02/2021,02/17/2021,15.0,PVT,"Patient does not remember medications, does not have a list with her",None,None,,None,"['Chills', 'Dyspnoea', 'Pain', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1066376,WV,55.0,F,"I had the normal soreness in my arm, slight nausea the first few days. On Wednesday, February 17 all my joints started to hurt. When I woke up on the 18th I could barely walk. My right knee was swollen, both hands were swollen, I had pain in my neck to the base of my skull. I called the doctor's office and told this was normal and to take Tylenol. I spent the weekend barely able to move by the following Thursday, February 25th I went to my doctor, who immediately sent me to the ER. I was admitted to the hospital. My inflammation was high. I was dehydrated. I spent the night in the hospital. Doctors say there is not enough research to say this vaccine did this but I know it did. I am still having problems, still can barely walk, pain in the joints of my hands and pain radiating up my neck to the bottom of my skull.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/13/2021,02/17/2021,4.0,PVT,"Lisinopril 10 mg, Lexapro 20mg, Vitamin B1, B6, B12, Turmeric 250 mg, Probiotic",None,None,,NKA,"['Arthralgia', 'Blood test abnormal', 'Dehydration', 'Gait disturbance', 'Inflammation', 'Joint swelling', 'Mobility decreased', 'Nausea', 'Neck pain', 'Pain', 'Pain in extremity', 'Peripheral swelling']",1,MODERNA,IM 1066385,CA,77.0,F,"swollen glands in left neck, ER room visit, IV vincomyacin and anti-inflammatories, 3 days in hospital, transferred to oral antibiotics (Clindamycin and Cipromyacin),",Not Reported,,Yes,Yes,3.0,Not Reported,U,02/06/2021,02/23/2021,17.0,OTH,"lisinopril, metoprolol, low dose aspirin, ezetimibe, evening primrose oil, calcium, vitamins D3, B12, C, Calcium, estradiol suppository,",none,"hypertension, cyst in left ovary being monitored, osteopenia, LCD artery repaired with stent, MRSA risk, arthritis and left knee replaced",,none significant,"['Blood test', 'Computerised tomogram', 'Coronary arterial stent insertion', 'Echocardiogram', 'Lymphadenopathy', 'X-ray dental']",UNK,PFIZER\BIONTECH,IM 1066440,MO,91.0,F,CVA type symptoms .ALTEPLASE given,Not Reported,,Not Reported,Yes,,Yes,U,02/23/2021,02/28/2021,5.0,PVT,,,,,NKDA,"['Computerised tomogram head', 'Neurological symptom']",2,PFIZER\BIONTECH,IM 1066454,OH,80.0,F,Patient admitted to hospital with Covid-19 Pneumonia on 02/19/2021. Diagnosed with bronchitis prior week. Having cough and shortness of breath with associated fever x1week,Not Reported,,Not Reported,Yes,12.0,Not Reported,N,01/21/2021,02/12/2021,22.0,PVT,"Tylenol, Pro-Air, Xanax, aspirin, Pradaxa, breo ellipta, Humalog, hytone, Lantus, DuoNeb, probiotics, synthroid, cozaar, zaroxolyn, nitrostat, mycostatin, Zofran, protonix, pravachol, aldactone, ultram, Effexor XR, vitamin E, zinc",small bowel obstruction 06/15/2020; acute bronchitis 02/20/2020; cellulitis 02/04/2020,"Atrial fibrillation, CAD, HTN, venous insufficiency, nonrheumatic aortic valve stenosis, chronic diastolic heart failure, COPD, vitamin D deficiency, morbid obesity, chronic constipation, GERD, Type 2 Diabetes Mellitus, fibromyalgia, osteosrthritis, hypercholesterolemia, depression, pacemaker, lymphedema",,Ciprofloxacin,"['Bronchitis', 'COVID-19 pneumonia', 'Chest X-ray abnormal', 'Cough', 'Dyspnoea', 'Lung opacity', 'Pyrexia']",1,MODERNA,IM 1066455,IL,35.0,M,Guillian Barre Syndrome,Not Reported,,Yes,Yes,7.0,Yes,N,01/26/2021,02/15/2021,20.0,PVT,none,none,none,,none,"['Electromyogram', 'Guillain-Barre syndrome', 'Magnetic resonance imaging spinal', 'Nerve conduction studies']",2,MODERNA,IM 1066484,MS,65.0,M,"Received vaccination at 14:20 2/26/21. Was observed until discharged at 15:15. Discharged per wheel chair to lobby in alert/stable condition, to wait on bus to take him home. At 18:00 his neighbor heard him fall, could not get patient to answer phone, found him unresponsive. Neighbor called 9-1-1, ambulance personnel could not revive patient. Coroner's office ruled his death as Natural Causes due to Hypertension, Cardiac disease, Diabetes, ESRD. There were no indication of anaphylactic reaction noted when I questioned the coroner's office. The Coroner's office/EMS were aware the patient had received the Moderna COVID 19 vaccination that day.",Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,N,02/26/2021,02/26/2021,0.0,OTH,"In-center meds: Doxercalciferol, Cinacalet,Mircera, LiquaCel. Home medication: Amlodipine 5mg 1 daily, ASA 81mg. 1 daily, Atorvastatin 40mg 1 at night, Auryxia 210mg 1 three times a day, Daily Multi-vitamin 1 daily, 6.25mg 2 tablets every",Same as listed in # 12.,"Hypertnesion, Cardiovascular disease, Diabetes Type 2, End Stage Renal Disease, Amputee,",,Morphine Xarelto,"['Cardiac disorder', 'Death', 'Diabetes mellitus', 'End stage renal disease', 'Fall', 'Hypertension', 'Unresponsive to stimuli']",1,MODERNA,IM 1066536,FL,,M,"two bad episodes of Atrial Fibrillation; slept for like a day and a half; Felt lethargic; A spontaneous report was received from two consumers and a healthcare professional concerning a male patient of unknown gender, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced two bad episodes of Atrial Fibrillation, Slept for like a day and a half and Felt lethargic. The patient's medical history included Atrial Fibrillation. Products known to have been used by the patient, within two weeks prior to the event, included Multaq, at 400mg two times a day for Atrial Fibrillation. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number: not provided). On 14 FEB 2021, approximately one day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029K20A) intramuscularly in for prophylaxis of COVID-19 infection. On 15 Feb 2021, the patient experienced two bad episodes of Atrial Fibrillation, slept for like a day and a half and felt lethargic. No treatment was given for the reported events. The action taken with mRNA-1273 in response to the events was considered not applicable, as the patient received both the doses of Moderna's COVID-19 vaccine prior to the events. The outcome of the events was unknown.; Reporter's Comments: This case concerns a male patient, with medical history of atrial fibrillation, who experienced a serious unexpected event of atrial fibrillation, after receiving second dose mRNA- 1273 (Lot# 029K20A). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Noting the patient's history of atrial fibrillation. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/14/2021,02/15/2021,1.0,UNK,MULTAQ,,Medical History/Concurrent Conditions: Atrial fibrillation,,,"['Atrial fibrillation', 'Lethargy', 'Somnolence']",2,MODERNA,OT 1066537,AR,73.0,F,"Pneumonia; A spontaneous report was received from a consumer concerning his mother, a 73-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia. The patient's medical history included chronic obstructive pulmonary disease (COPD). Concomitant product use was not provided by the reporter. On 19 Jan 2021, approximately five days prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient developed a cough. The patient's temperature was recorded at 101 degrees Fahrenheit. The patient went to doctor. She was fatigued and coughing blood and was diagnosed with pneumonia. Treatment included azithromycin, and the patient seemed to improve. On 05 Feb 2021, the patient developed a temperature of 101�F, coughed up blood and was very fatigued. She was diagnosed with pneumonia. Treatment for the event included levofloxacin. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, pneumonia, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of pneumonia, a causal relationship cannot be excluded. Patient's elderly age and medical history of COPD are considered a risk factors.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,01/23/2021,4.0,UNK,,COPD,,,,"['Body temperature', 'Pneumonia']",1,MODERNA,OT 1066538,OH,,M,"organs shut down after vaccine; A spontaneous report was received from a female consumer via social media regarding her father, unknown age, who was administered Moderna Covid-19 Vaccine and have experienced multiple organ failure. The patient's medical history was not provided. His concomitants were not provided. On an unspecified date, prior to onset of symptoms, the patient received their a planned doses of mRNA-1273 (Lot Number: unknown) unknown route of administration. It is not known whether patient received first dose or 2nd dose of vaccine. On an unknown date the patient experienced shut down of multiple organs. It was noted that the doctors said, there was no concrete proof that its due to vaccine. But according to her, the patient was fine till he had the vaccine. Treatment details were not provided. Doctors talked about do not resuscitate orders with her. Action taken with the vaccine is unknown. The outcome of the event multiple organ failure is unknown at the time of report.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of Multiorgan failure after receiving mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Due to lack of contact details, no follow-up information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Multiple organ dysfunction syndrome'],1,MODERNA,OT 1066539,VA,40.0,F,"Received the vaccine subcutaneously; Received vaccine a little lower in the arm than the deltoid muscle; A spontaneous report was received from Healthcare Professional concerning a 40-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced received the vaccine subcutaneously and a little lower in the arm than the deltoid muscle The patient's medical history was not provided. Concomitant medications were not reported. On 25 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 039K20A) subcutaneously in the arm for prophylaxis of COVID-19 infection On 25 Jan 2021, the patient experienced received the vaccine subcutaneously and a little lower in the arm than the deltoid muscle. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event received the vaccine subcutaneously and a little lower in the arm than the deltoid muscle was resolved on 25 Jan 2021.; Reporter's Comments: This report refers to a case of inappropriate route of vaccine administration and vaccine administered at inappropriate site for mRNA-1273 (Batch Number: 039K20A) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Incorrect route of product administration', 'Product administered at inappropriate site']",1,MODERNA,OT 1066540,MI,59.0,F,"felt sick; sore throat with blisters/ vesicles; had a really bad sore throat; tired; achy; her necklines were swollen; redness in back; she was exposed to someone who previously had Covid-19; This is a spontaneous report from a Pfizer-sponsored program and from a Pfizer-sponsored program. A contactable nurse (reporting for herself) reported that a 59-year-old female patient, received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0142), via an unspecified route of administration on 11Jan2021 (at the age of 59) as a single dose for COVID-19 immunization. The patient's medical history included depression from an unknown date. The patient's concomitant medications included duloxetine hydrochloride (CYMBALTA) from an unknown date as an antidepressant. The patient previously received first dose of BNT62B2 (Lot number EJ1685) on 21Dec2020. The patient experienced feeling sick for 3 days after receiving the second dose. The patient may have been exposed to someone who previously had COVID-19 on 27Jan2021 and experienced really bad sore throat with blisters and tiny bubbles on the back of her throat, redness back there and there was little vesicle (called it ""Covid throat""); was tired and achy and her necklines were swollen a week later on an unknown date in Feb2021. The patient underwent lab tests which included Rapid COVID Test on 10Feb2021 and 12Feb2021 with negative results; herpes test on an unknown date with negative results and strep test on an unknown date with negative results. Therapeutic measures were taken as a result of the event COVID-19 exposure which included tetracycline on the 10th (stopped on the 12th as the tests negative). The outcome of the events throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19 was unknown. Follow up (16Feb2021): New information received from a contactable healthcare provider and from a Pfizer-sponsored program includes: product details (lot numbers, second dose information), new events (throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19), and lab data.; Sender's Comments: Event blisters and tiny bubbles on the back of throat represents an intercurrent medical condition and unrelated to BNT62B2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/27/2021,16.0,UNK,CYMBALTA,,Medical History/Concurrent Conditions: Depression,,,"['Exposure to SARS-CoV-2', 'Fatigue', 'Herpes simplex test', 'Malaise', 'Oropharyngeal blistering', 'Oropharyngeal pain', 'Pain', 'Pharyngeal erythema', 'SARS-CoV-2 test', 'Streptococcus test', 'Swelling']",2,PFIZER\BIONTECH, 1066556,TX,76.0,M,"Stroke, Pulmonary embolism, kidney failure",Not Reported,,Yes,Yes,14.0,Yes,N,02/04/2021,02/16/2021,12.0,PHM,Sotalol 40mg twice daily Plavix 75mg once daily Amlodipine 5mg twice daily Rosuvastatin Calcium 10mg once daily Aspirin 325mg,None,Afib/tachycardia Heart attack Sleep Apnea,,NKDA,"['Cerebrovascular accident', 'Pulmonary embolism', 'Renal failure']",1,MODERNA,SYR 1066557,NJ,56.0,M,nerve related hearing loss that came on 24 hours after injection and progressed to total hearing loss in one ear after 72 hours,Not Reported,,Not Reported,Not Reported,,Yes,N,02/24/2021,02/26/2021,2.0,OTH,none,none,none,,none,"['Audiogram abnormal', 'Deafness neurosensory', 'Deafness unilateral']",2,MODERNA,SYR 1066575,IA,78.0,F,"2 days after receiving first dose of vaccine, patient called to report worsening shortness of breath, back pain, fatigue and a cough. She was sent to the emergency room for evaluation. At that time, she was given a 7 day course of antibiotics. Patient then presented to the ED on 02/25/2021, with worsening symptoms, and was found to be COVID positive.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,02/06/2021,02/08/2021,2.0,PVT,,Pneumonia,"COPD, Atrial Fibrillation, CHF, Hypertension, Chronic Kidney Disease",,,"['Back pain', 'COVID-19', 'Cough', 'Dyspnoea', 'Fatigue', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1066597,WV,79.0,F,"2/17 kidney failure, lost electrolytes,",Not Reported,,Not Reported,Yes,10.0,Not Reported,N,01/14/2021,01/16/2021,2.0,PHM,"corgard 40mg, baclofen 10mg, klonopin 0.5mg, baby aspirin,",,dystonia,,,"['Computerised tomogram', 'Dehydration', 'Magnetic resonance imaging head', 'Renal failure']",1,MODERNA,IM 1066611,CA,75.0,F,"After approximately 10 minutes Pt started clearing her throat repetitively and complaining of chest pain, shortness of breath and tingling/swelling if her tongue. Pulse Ox was taken and Pt was at 97% on room air and pulse of 84. 1st dose of Epi 0.3 mg given IM in left thigh at 1156, followed by IM injection in left thigh of Benadryl 50 mg. Pty placed on 2L O2 by nasal cannula. Lungs clear, Pt was not stridulous. EMS called and arrived at 7 minutes after injection of Epi. Pt transported to ED via ambulance, departed without incident.",Not Reported,,Yes,Not Reported,,Not Reported,U,03/02/2021,03/02/2021,0.0,OTH,"Albuterol, fluorometholone, GaviLyte-G, hydrocodone-acetaminophen, lisinopril-hydrochlorothiazide, Natural Psyllium Fiber, Pred Mild, propranolol, valacyclovir.",None,"anemia, arthritis, asthma, chronic low back pain, disorder of bone and articular cartilage, edema of lower extremity, hyperlipidemia, hypertensive disorder, obstructive sleep apnea syndrome, pain in left knee, pain in left lower limb, sleep apnea, synovial cyst of popliteal space (left).","Reported long term effects from flu shot 40 years ago, described as chronic fatigue and muscle weakness",Aleve,"['Chest pain', 'Dyspnoea', 'Paraesthesia oral', 'Swollen tongue', 'Throat clearing']",1,MODERNA,IM 1066617,NJ,85.0,M,"Patient reported on 2/24/2021 to have expired on an unknown date during the interim between first dose and scheduled 2nd dose. On 2/24/2021, the person reporting death stated that patient died ""last week."" Patient is not known to us for primary care and vaccine was administered during a vaccine event at senior public housing. We have no further medical details about the cause of death or if it is vaccine related.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,02/24/2021,28.0,PVT,Unknown,Unknown,Unknown--Patient using Oxygen via Nasal Canula at time of immunization,,No allergies reported,['Death'],1,MODERNA,IM 1066629,AZ,38.0,F,"I received the Covid Vaccine on January 22, 2021. I started developing a headache when I came home. Later that night my mouth felt funny. The next day I noticed that I had mouth sores. I had those for about 2 days. I felt fatigue and had some joint pain through out the next few days. On January 27th I woke up with a numb arm in the arm I had the shot administered. Right away I felt feverish and nausea. I threw up immediately. After that I was very disoriented. I was able to fall back asleep a few hours later. I woke up again with a numb arm and the same feverish and nausea and again I threw up immediately. This time I dried heaved but at the same time I could not breath and was having a strong feeling of electricity running through my hands and arms. I emailed my doctor and went back to sleep. A little while later I woke up again with a numb arm and again feverish and nausea and I dried heaved and at the same time had difficulty breathing and same feeling of electricity runny through my hands and arms. My doctor instructed me to go to the ER. I went on January 28th. All that day I had a headache and on I kept having the feverish and nausea but did not through up again. The days of January 28th to February 6th I was experiencing a foggy brain, headache, and fatigue. I was having difficulty figuring out how to do a task that I do everyday and is not hard for me normally and made my brain hurt. On February 6th I woke up again but this time I had abdominal pain and again feverish and nausea and I dry heaved again with difficulty breathing and again the electricity running through my hands and arms. On February 7th I was very tired and fatigue. Monday February 8th, I started to have this back pain that than lead into this headache and feverish and nausea. Then on February 9th I had this strange hip pain along with the same back pain and headache again this time was worse than the day before. I continued to have this strange back pain along with this tightness in my chest and difficulty breathing. On February 11th I woke up again but this time my heart was racing verry fast and I felt feverish and was having difficulty breathing so much so, I was using a paper bag to help. I went to the ER again because it was my heart and it hurt, and my back hurt along with the tightness in my chest. The days from February 12th to now I am still experiencing this strange back pain, headaches off and on fatigue, and I have been experiencing the foggy brain. My second shot was supposed to be on February 16th but my doctor instructed me not to get it due to my experience with the first shot. I am asking for help with paying for the ER visits and any other medical expenses related to this due to the reaction from my first vaccine. I am still experiencing the strange back pain, that started on February 8th, foggy brain and headaches and fatigue that I am still receiving medical attention for.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/22/2021,01/22/2021,0.0,PVT,Multi Vitamins,None,High Lipoprotein A,,None,"['Abdominal pain', 'Apolipoprotein', 'Arthralgia', 'Back pain', 'Blood magnesium', 'Blood test', 'Blood thyroid stimulating hormone', 'Chest X-ray', 'Chest discomfort', 'Confusional state', 'Disorientation', 'Dyspnoea', 'Electric shock sensation', 'Electrocardiogram', 'Fatigue', 'Feeling abnormal', 'Fibrin D dimer', 'Full blood count', 'Headache', 'Hypoaesthesia', 'Injection site hypoaesthesia', 'International normalised ratio', 'Loss of personal independence in daily activities', 'Metabolic function test', 'Nausea', 'Palpitations', 'Pregnancy test urine', 'Prothrombin time', 'Pyrexia', 'Retching', 'Stomatitis', 'Troponin T', 'Urine analysis', 'Vitamin D', 'Vomiting']",1,MODERNA,SYR 1066632,MI,73.0,M,"Extreme bloating of stomach and chest area. Some swelling in neck and face. Hospitalized after normal Upper GI series for CT Scan and other testing. Release from hospital for outpatient Endoscopy . Treated with colace, miralax for constipation. Did not resolve discomfort.",Not Reported,,Not Reported,Yes,10.0,Not Reported,N,02/15/2021,02/21/2021,6.0,OTH,Metformin 500 mg - a.m. and p.m. Baby Aspirin - 81 mg - a.m. Lisiniprol - HCTZ 10/12 a.m. Atorvastatin 40 mg p.m. Lexepro - a.m. Atenolot 50 mg a.m. Clopidogrel 75 mg a.m. Vit D - a.m. Multi Vitamin a.m,"Mild Stroke - February 8, 2021 Hospitalized for 3 days and sent home without restrictions",heart disease pre-diabetic,,sudafed,"['Abdominal distension', 'Computerised tomogram normal', 'Constipation', 'Discomfort', 'Laboratory test normal', 'Swelling', 'Swelling face', 'X-ray with contrast upper gastrointestinal tract normal']",2,PFIZER\BIONTECH,IM 1066636,IL,66.0,M,"Seizure around 4:40 am on 2/27/2021. Shaking, eyes drawn in, fists clenched, some foaming at mouth, unresponsive. Ambulance called to the home. Transported to hospital.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/18/2021,02/27/2021,9.0,PVT,"Prescriptions: Valsartan, Atorvastation, Tadalafil, Baby Aspirin Vitamins: Multivitamin, Calcium, Vitamin D3 1000 units, Lutein",None,"High Blood Pressure, sleep apnea, loop recorder to monitor heart",,None,"['Blood test', 'Computerised tomogram', 'Eye disorder', 'Foaming at mouth', 'Joint contracture', 'Magnetic resonance imaging', 'Seizure', 'Tremor', 'Unresponsive to stimuli']",2,MODERNA,SYR 1066649,CA,51.0,M,"fever to 104, thrombocytopenia. Started 2/28/21. had leukocytosis, near syncope and high recurrent fever with all cultures negative. Is improving as of 3/2/21.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/25/2021,02/28/2021,3.0,PVT,"insulin, tylenol, neurontin, flexeril, zofran, pepcid, renvela, zenpep, lipitor, tapazole, trazodone, flonase, alprostadil, lantus, adair,",Covid positive test 12/18/20,"esrd on hd, blindness, depression, obesity, osa, vit d def, gerd, dm 1, chronic pancreatitis, asthma, anemia due to ckd",,"Ace inhibitors, ciprofloxacin","['Blood culture negative', 'Chest X-ray', 'Culture negative', 'Full blood count', 'Leukocytosis', 'Presyncope', 'Pyrexia', 'Thrombocytopenia', 'Urine analysis']",1,MODERNA,IM 1066687,MI,59.0,F,"i woke up at 3am with chest pain on 01-11-2021. I went to the hospital and was diagnosed with pericarditis. At the hospital, an EKG, echocardiogram, US of the abdomen, MRI of the chest, lab work, cardiac marker series , CRP and a scheduled exercised test was done that picked up arrhythmia. I am now recovering and I am still taking Colchicine, a gout medication that treats inflammation and pericarditis. I am on this medication till mid April 2021 when I see my cardiologist for follow up.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,12/23/2020,01/11/2021,19.0,PVT,"OTC MEDICATIONS, GLUCOSAMINE, CITRACEL, FISH OIL, CALCIUM D",,"SLIGHT MICROVALVE PROLAPSE, GILBERT SYNDDROME, CELIAC DISEASE",,"ERYTHROMYCIN, CELIAC DISEASE","['Arrhythmia', 'C-reactive protein', 'Cardiac stress test abnormal', 'Chest pain', 'Echocardiogram abnormal', 'Electrocardiogram abnormal', 'Laboratory test abnormal', 'Magnetic resonance imaging thoracic abnormal', 'Myocardial necrosis marker', 'Pericarditis', 'Ultrasound abdomen abnormal']",1,PFIZER\BIONTECH,IM 1066688,TX,72.0,M,"Patient developed bleeding from the gums soon after the first shot, did not notify medical personnel until his second vaccine. Platelet count was found to be 3000 on March 2",Not Reported,,Yes,Yes,,Not Reported,U,01/29/2021,01/30/2021,1.0,UNK,"Vitamin B 12, digoxin, Xarelto, atorvastatin, metoprolol, allopurinol, Finasteride",None,"Atrial fibrillation, hypertension, gout, benign prostate hypertrophy, hyper cholesterolemia ,diet controlled diabetes",,None,"['Gingival bleeding', 'Platelet count decreased']",2,MODERNA, 1066715,IL,85.0,M,epistaxis.,Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/21/2021,23.0,SEN,"mvi, albuterol, invanz, macrobid, flomax, metoprolol, enalapril,","copd, prostate ca",,,NKA,['Epistaxis'],1,MODERNA,IM 1066721,CA,60.0,F,2 days after the second dose of the moderna vaccine I suddenly started seeing blurry out of my right eye I let it go for about 4 days thinking it was something just in my eyes I sent after that went to an urgent care at my doctor's office where they sent me to the ER I had an MRI done nothing was found was then sent to opthamologist specialist who at first diagnosed me as a torn retina second day I went to a retina specialist who confirmed it was not a torn right now but swollen behind my eyes I wasn't to be seen until another week later and hopes the swelling would go down and February 25th I return back to dr. When the retina specialist who indicated that it was still swollen and it's a possibility I will not see clearly out of that high again still waiting for various specialties,Not Reported,,Not Reported,Not Reported,,Yes,N,02/10/2021,02/12/2021,2.0,PUB,Vitamins only,,,,,"['Eye swelling', 'Laboratory test', 'Magnetic resonance imaging normal', 'Papilloedema', 'Retinal tear', 'Vision blurred']",2,MODERNA,IM 1066742,SC,73.0,F,"Pt contracted Covid, symptoms started 4 days after vaccine (feb 8 was vaccine). symptoms started feb 12, hospital feb 15, still in hospital as of march 3",Not Reported,,Not Reported,Yes,18.0,Not Reported,N,02/08/2021,02/15/2021,7.0,PHM,unknown,unknown,unknown,,none,"['COVID-19', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1066744,IL,65.0,F,"2/3 rehab visit: PA - 02/03/2021 12:25 PM CST Formatting of this note might be different from the original. NURSING HOME ACUTE VISIT 6/24/1955 MD SUBJECTIVE: Chief Complaint Patient presents with ? Cough Pt has COVID 19 and she is coughing and congestion. This is an acute visit with pt. Status and changes discussed with staff. Advanced directives on file. Allergies reviewed at NH, though may not be fully updated in electronic record. Problem List reviewed. ROS: Gen: Denies fever CV: Denies chest pain Resp: Denies dyspnea GI: Denies abdominal pain. GU: Denies dysuria. Psych: Denies depression. OBJECTIVE: VITALS: Vitals: 02/03/21 1226 BP: (!) 94/54 Pulse: 79 Resp: 18 Temp: 37 �C (98.6 �F) SpO2: 96% PHYSICAL EXAM: General: Alert, awake, no acute distress Skin: Intact HEENT: Grossly normal Neck: Supple Lungs: Within normal limits/clear CV: RRR Abdomen: Soft, BS active Extr: WNL Neuro: Unchanged and nonfocal ASSESSMENT/PLAN: Reviewed and signed orders. Recheck in 60 days. Patient was seen today for cough. Diagnoses and all orders for this visit: COVID-19 Cough CXR 2 view. Plan to start melatonin, vit D3, zinc. Rehab nurse note: Table of Contents for Miscellaneous Notes Telephone Encounter - RN - 02/09/2021 9:30 AM CST Telephone Encounter - 02/09/2021 9:16 AM CST Telephone Encounter - RN - 02/09/2021 9:30 AM CST Discussed with Dr. and he recommended that patient go to ER for urgent evaluation/treatment with dyspnea and low O2 levels even with supplemental oxygen. � Electronically signed by RN at 02/09/2021 9:32 AM CST� Back to top of Miscellaneous Notes Telephone Encounter - 02/09/2021 9:16 AM CST Rehab called, they stated PT was having trouble breathing and her O2 was 80 with oxygen. They wanted to know if they should bring her in but PT is Covid positive. Staff recommended that she go to the ER. � Electronically signed at 02/09/2021 9:17 AM CST� 2/9 ER-> admission note: (6day admission) History The patient is a 65 y.o. female with a past medical history notable for History of anemia, anxiety, cirrhosis, COPD, CHF, diabetes, reflux, hypertension. The patient presents for evaluation of Worsening issues of cellulitis in addition to the patient's history of recent Covid 19 infection. Patient also tested positive for influenza. Patient was started on steroids at skilled care facility. Patient was already on breathing medications. Patient has had issues with CHF and lower extremity swelling. Patient was taking a diuretic for this. Due to patient's cerebral kidney function patient is not a candidate for certain medications or either influenza, Covid 19 and we are limited on antibiotics. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. 3/1/21 er to admission note: currently inpatient History The patient is a 65 y.o. female presents for evaluation of altered mental status. Notable PMHx: CHF, morbid obesity, diabetes, � Patient is 3 weeks out from hospitalization for COVID-19 pneumonia. She has been more confused over the couple of days before admission. Because of altered mental status, patient was transferred to the emergency room. Patient also had some shortness of breath. In the ER, she had a chest x-ray which showed moderate interstitial infiltrate secondary to pulmonary edema or pneumonia. Lab work did show a UTI. BNP was normal at 45. Creatinine was near her baseline at 1.8. She did have elevated alkaline phosphatase at 452. White count was elevated at 14.7. Patient was difficult to arouse in the ER. � On my exam, patient is difficult to arouse. After shaking her shoulder and yelling at her, she did open her eyes and say to me ""I'm ok"" before closing her eyes again. She is satting well on nasal canula oxygen. �",Not Reported,,Not Reported,Yes,8.0,Not Reported,N,01/20/2021,02/03/2021,14.0,SEN,Current Outpatient Medications on File Prior to Encounter Medication Sig Dispense Refill ? acetaminophen (TYLENOL) 325 MG tablet Take 650 mg by mouth every 6 hours as needed for Pain � � ? albuterol (PROVENTIL) (2.5 MG/3ML) 0.083% nebulizer,,,,nka,"['Activated partial thromboplastin time prolonged', 'Ammonia increased', 'Anxiety', 'Bilirubin urine', 'Blood alkaline phosphatase increased', 'Blood bicarbonate increased', 'Blood calcium decreased', 'Blood chloride normal', 'Blood creatine phosphokinase decreased', 'Blood creatinine increased', 'Blood gases', 'Blood glucose increased', 'Blood lactic acid normal', 'Blood pH normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea increased', 'Blood urine present', 'Brain natriuretic peptide normal', 'COVID-19', 'Carbon dioxide normal', 'Cardiac failure congestive', 'Cellulitis', 'Chest X-ray abnormal', 'Condition aggravated', 'Confusional state', 'Cough', 'Culture urine', 'Differential white blood cell count', 'Dyspnoea', 'Full blood count', 'Glomerular filtration rate decreased', 'Glucose urine absent', 'Haematocrit normal', 'Haemoglobin normal', 'Hyporesponsive to stimuli', 'Influenza', 'Influenza virus test positive', 'International normalised ratio', 'Lung infiltration', 'Lymphocyte count decreased', 'Lymphocyte percentage decreased', 'Mean cell haemoglobin', 'Mean cell haemoglobin decreased', 'Mean cell volume normal', 'Mean platelet volume normal', 'Mental status changes', 'Monocyte count normal', 'Monocyte percentage', 'Neutrophil percentage decreased', 'Nitrite urine absent', 'Oxygen saturation decreased', 'PO2 normal', 'Pain', 'Physical examination normal', 'Platelet count decreased', 'Platelet function test abnormal', 'Pneumonia', 'Procalcitonin increased', 'Protein urine absent', 'Prothrombin level normal', 'Pulmonary oedema', 'Red blood cell count increased', 'Red blood cell morphology normal', 'Red blood cell nucleated morphology', 'Red cell distribution width increased', 'Respiratory tract congestion', 'SARS-CoV-2 test positive', 'Swelling', 'Troponin I normal', 'Urinary casts', 'Urinary occult blood negative', 'Urinary tract infection', 'Urine analysis abnormal', 'Urine ketone body absent', 'Urine leukocyte esterase', 'Urobilinogen urine', 'White blood cell count increased', 'pH urine normal']",2,PFIZER\BIONTECH,IM 1066762,MD,23.0,F,"24 y.o. female with no significant past medical history who was diagnosed with COVID-19 (NP PCR on 1/27/2021) with mild symptoms (3-4 days of rhinorrhea and myalgia) and complete recovery with return to work who recently completed COVID-19 vaccine series (Pfizer 1/8/2021, 2/5/2021) now presenting for hospitalization (2/26/2021) with fever, rapidly progressive hypoxia, and hyperinflammatory state including elevated ESR, CRP, ferritin, D-dimer, and troponin (20) in the setting of positive COVID-19 NP PCR (2/26/2021) and positive S.pneumoniae urine ag with clinical diagnosis of MIS-A s/p high dose methylprednisolone and IVIG.",Not Reported,,Yes,Yes,4.0,Not Reported,N,01/08/2021,02/26/2021,49.0,PVT,none,none,none,,none,"['Blood creatine phosphokinase increased', 'Blood lactic acid', 'C-reactive protein increased', 'COVID-19', 'COVID-19 pneumonia', 'Computerised tomogram thorax abnormal', 'Echocardiogram', 'Echocardiogram abnormal', 'Ejection fraction decreased', 'Fibrin D dimer', 'Gastrointestinal wall thickening', 'Hypoxia', 'Immunoglobulin therapy', 'Inflammation', 'Influenza A virus test positive', 'Influenza B virus test positive', 'Lung opacity', 'Lymphadenopathy', 'Myalgia', 'Pericardial effusion', 'Pyrexia', 'Red blood cell sedimentation rate increased', 'Respiratory syncytial virus test positive', 'Rhinorrhoea', 'Right ventricular dilatation', 'SARS-CoV-2 test positive', 'Serum ferritin increased', 'Splenomegaly', 'Streptococcus test positive', 'Systemic inflammatory response syndrome', 'Tricuspid valve incompetence', 'Troponin increased', 'Ventricular hypokinesia']",1,PFIZER\BIONTECH,IM 1066770,IL,97.0,M,died,Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/09/2021,15.0,SEN,"lasix, seroquel, kcl, coreg, eliquis, vasotec,omeprazole, tylenol, rocephin",,,,NKA,['Death'],2,MODERNA,IM 1066784,MA,55.0,F,Severe Muscle pain throughout my entire left side and severe joint pain left side only. Severe arm pain at the site of injection. This pain was severe visceral pain and lasted for over 6+ weeks. Only on my left side. The pain was present when simply sitting as well as during activity. There are still days when the pain returns for no reason at all. The pain is deep inside my left thigh and lower leg. I need to take ibuprophen to decrease the discomfort.,Not Reported,,Not Reported,Not Reported,,Yes,U,01/12/2021,01/13/2021,1.0,SEN,None,None,None,,Penicillian,"['Arthralgia', 'Injection site pain', 'Myalgia', 'Pain in extremity', 'Visceral pain']",1,PFIZER\BIONTECH,IM 1066785,CA,69.0,F,Bells palsy developed 2 d later.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/23/2021,02/25/2021,2.0,PVT,"acetaminophen 325 mg oral tablet, 650 mg= 2 tab, Oral, q6hr, PRN, 1 refills meloxicam 7.5 mg oral tablet, 7.5 mg= 1 tab, Oral, Daily, 2 refills Moisture Eyes PM ophthalmic ointment, 1 app, OPHTH-Both, Once a day (at bedtime), PRN Narcan",None,Chronic pain,,PCN,"['Angiogram cerebral abnormal', 'Arteriogram carotid abnormal', ""Bell's palsy"", 'Computerised tomogram head normal', 'Lymphadenopathy']",1,MODERNA,IM 1066807,NY,32.0,F,"Gestational hypertension systolic 150, diastolic 100-109. Was first observed at during labor but did not continue through the course of that hospital stay. Patient was discharged 2/9 and instructed to monitor blood pressure at home once a day. Patient reports feeling slightly short of breath at home and symptoms were worsening. Patient experienced lightheadedness on 2/11. 2/11 was instructed to come to the hospital",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/30/2021,02/11/2021,12.0,PVT,"Pre natal, monthly allergy shots",,environmental allergies,,environmental allergies only,"['Angiogram normal', 'Blood pressure increased', 'Computerised tomogram normal', 'Computerised tomogram thorax normal', 'Dizziness', 'Dyspnoea', 'Exposure during pregnancy', 'Gestational hypertension', 'Labour complication', 'Liver function test abnormal']",2,MODERNA,IM 1066825,IL,79.0,M,Patient had dark urine and high CK level and was diagnosed with acute rhabdomyolysis. Patient received IV fluids and nephrology was consulted. Patient was discharged home when stable.,Not Reported,,Yes,Yes,,Not Reported,Y,02/23/2021,02/24/2021,1.0,PVT,"Ranibizumab, Humalog, Lantus, amlodipine 5 mg, enalapril 10 mg, jardiance 25 mg, hydrochlorothiazide, alirocumab, cholecalciferol, finasteride, freestyle meter with strips and lancets, tamsulosin, aspirin",none,"HTN, HLD, CAD S/P stent",,"Liraglutide- GI upset/nausea/vomiting, acute pancreatitis","['Blood creatine phosphokinase increased', 'Chromaturia', 'Rhabdomyolysis']",2,MODERNA,IM 1066829,WA,88.0,M,Patient passed away in his sleep that evening after he recieved his COVI vaccine. Patient had not been ill. No other information is known.,Yes,,Not Reported,Not Reported,,Not Reported,N,02/25/2021,03/02/2021,5.0,OTH,"atorvastatin, amlodipine, clopidogrel, metoprolol, losartan,",,"Atherosclerosis, PAD, CKD, Hypertension, Hyperlipidemia, Systolic Murmur, Hyperplasia fatty tissue, HX prostate cancer",,Aspirin,['Death'],1,PFIZER\BIONTECH,IM 1066831,,71.0,F,"Neurology consult note 2/16: The patient is a 72-year-old woman, who states that last Friday she began to notice a strange fullness and numbness and perhaps a mild degree of weakness in her right leg and came to Emergency Room. She was seen by ER doctors. Diagnosis was unclear. She was offered admission to get physical therapy, but she did not wish to stay for the weekend and returned home on Friday the evening only to come back to the ER on Sunday, 2 days later with progression of further right leg weakness, right leg numbness and a hint of new left-sided symptoms that had not begun before Sunday. None of her symptoms involve the arms or face and everything was below the waist. There was no significant pain. She has not had a bowel movement since Thursday and has lost the ability to void. Her MRI scan of the lumbosacral spine was reviewed by me on the computer monitor and was unrevealing except for mild DJD. Thoracic MRI scan shows possible spinal cord infarction versus myelitis occurring within the thoracic spine at the dorsal surface of the cord at the T5 and T6 vertebral body levels to the right of midline. This was a faint finding and not clearly infarct or myelitis and could be artifact. It appears that she has hydronephrosis on her scans too and now is using a Foley catheter. She does have a history of high cholesterol for which she takes a statin at home and was taking a baby aspirin a day when the above symptoms occurred. In summary, the patient has a 72-year-old woman, who presents with progressive right lower extremity weakness and now evolving left lower extremity weakness. This may be related to an autoimmune process such as myelitis or less commonly cord ischemia. Normally, I would start her on Plavix, but I think she may need to undergo spinal tap tomorrow if MRI scan of the brain and cervical spine are unrevealing. Patients with mild hyperglycemia can develop a diabetic amyotrophy or lumbosacral plexopathy simply related to diabetes, which is a diagnosis of exclusion. Speaking against this would be that her reflexes are intact at both knees at 2+ to 3 and slightly brisk, 1+ at both ankles and 1+ and symmetric in the upper extremities. We will hold aspirin for today. Consider LP for tomorrow, but have not ordered as we will try to avoid and hopefully the imaging studies I have ordered will be sufficient. We will continue to follow. While admitted to this facility, she was treated with IV dexamethasone 2/14-2/21 She was admitted to an inpatient hospital 2/14-2/23 and discharged to an inpatient rehab unit at a different health system.",Not Reported,,Not Reported,Yes,9.0,Not Reported,U,01/25/2021,02/12/2021,18.0,PUB,,,,,,"['Abdominal distension', 'Albumin CSF normal', 'Balance disorder', 'Bladder catheterisation', 'Blood glucose normal', 'Blood immunoglobulin G normal', 'CSF electrophoresis', 'CSF glucose normal', 'CSF immunoglobulin', 'CSF lymphocyte count normal', 'CSF monocyte count', 'CSF myelin basic protein normal', 'CSF protein normal', 'CSF red blood cell count', 'Constipation', 'Electromyogram normal', 'Hydronephrosis', 'Hypoaesthesia', 'Intervertebral disc protrusion', 'Lymphocyte count increased', 'Macrophages increased', 'Magnetic resonance imaging head normal', 'Magnetic resonance imaging spinal abnormal', 'Magnetic resonance imaging thoracic abnormal', 'Monocyte count increased', 'Muscular weakness', 'Myelitis', 'Nucleated red cells', 'Osteoarthritis', 'Protein total normal', 'Sensory disturbance', 'Spinal stenosis', 'Urinary retention', 'Vertebral foraminal stenosis']",UNK,MODERNA,IM 1066835,MI,54.0,F,"I had my 2nd does of the Pfizer vaccine on February 27, 2021. The next morning I awoke with a very bad headache. I took and Advil. My husband was making breakfast. I came downstairs, ate, had a cup of coffee, then got a glass of water and an ice pack and sat on a recliner in the living room. I don't remember much of the rest. It was like a dream. My husband said I let out a yell, my arms flailed and my eyes were very strange. I lost muscle strength in my lift side mimicking a stroke. He called 911. I was taken to Emergency facility where I gained consciousness. I was then transferred to Hospital. So far every test has come back negative. I have an EEG scheduled for this Thursday.",Not Reported,,Yes,Yes,2.0,Not Reported,Y,02/27/2021,02/28/2021,1.0,PVT,Previstatin,none,High Cholesterol,,None,"['Abnormal sensation in eye', 'Activated partial thromboplastin time normal', 'Angiogram cerebral normal', 'Arteriogram carotid normal', 'Blood magnesium normal', 'Cerebrovascular accident', 'Chest X-ray normal', 'Computerised tomogram head normal', 'Computerised tomogram neck', 'Dreamy state', 'Dyskinesia', 'Echocardiogram normal', 'Electroencephalogram', 'Full blood count normal', 'Glycosylated haemoglobin normal', 'Haemoglobin normal', 'Headache', 'International normalised ratio normal', 'Loss of consciousness', 'Magnetic resonance imaging head normal', 'Metabolic function test normal', 'Muscle strength abnormal', 'Prothrombin time normal', 'SARS-CoV-2 test negative', 'Screaming']",2,PFIZER\BIONTECH,SYR 1066852,KY,76.0,M,"History of terminal cancer, entered hospice care 1/2021, expired 2/28/2021. No reported adverse events from patient or family after receiving vaccine",Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,,02/24/2021,02/28/2021,4.0,PUB,Steroids,None,Terminal cancer- Hospice care started 1/2021,,None,['Death'],1,MODERNA,IM 1066855,TX,70.0,F,"Shortly after receiving the first dose of the vaccine, the patient started having profuse watery diarrhea on 2/11 and 2/12. She also stated she ""fell out"" on the same day. She was told to hydrate and then presented to the ED on 2/19 where she was found to be hypoxic down to the mid 80s. She was placed on 2L of O2 where her sat improved to 92%. She was febrile in the ED to 101.2 and had persistent fevers to 102.9 on the floor. COVID PCR testing negative x 2 and IgG positive. Patient received 6 days of antibiotics and supportive therapy. On 3/2 - Patient reports feeling better overall but still overall fatigue and not back to baseline. On 2-3 L NC. patient is still admitted",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/11/2021,02/12/2021,1.0,OTH,,,,,,"['Angiogram pulmonary abnormal', 'Diarrhoea', 'Fatigue', 'Hypoxia', 'Lung opacity', 'Pyrexia', 'SARS-CoV-2 antibody test positive', 'SARS-CoV-2 test negative', 'Syncope']",1,MODERNA,IM 1066881,GA,74.0,M,"FATIGUE, PAIN IN LEFT SHOLDER, LOSS OF MOVEMENTS AND 50% OF MUSCLE MASS ON LEFT SIDE",Not Reported,,Yes,Yes,4.0,Yes,N,02/24/2021,02/26/2021,2.0,PVT,B-12 1000 mg,,High Blood pressure Kidney Disease stage 3,,Percocet,"['Arthralgia', 'Fatigue', 'Injected limb mobility decreased', 'Injection site pain']",2,PFIZER\BIONTECH,SYR 1066903,CA,78.0,F,"Received first dose of vaccine on 2/9/2021, then hospitalized with covid infection on 2/16/2021",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,02/09/2021,02/16/2021,7.0,PVT,"spironolactone, Advair, bumex, bisprolol, losartan, atorvastatin, levothyrozine, omeprazole,",,"CAD, CHF, CKD, Asthma",,"Lisinopril, captopril, motrin",['COVID-19'],1,PFIZER\BIONTECH,IM 1066906,NY,92.0,M,"92 year-old male with PMHx of vascular dementia, BPH, MDD, sleep disturbance , basal cell carcinoma of neck, osteoarthritis, BLE edema, Guillain-Barre syndrome 30 years prior, s/p COVID positive on 1/11/21 and received IV Bamlanivimab. Sent to hospital on 2/2/21 for altered mental status, generalized weakness with inability to lift bilateral UE and difficulty moving his BLE. He was treated for UTI with 7 days of Cefepime for Morganella Morganii. He was followed by neurology with MRI of the brain and CT of the spine without acute findings. Lumbar puncture unable to be obtained. He received 5 day course of IVIG for presumed Guillain-Barre . EMG showed generalized sensory motor polyneuropathy both axon loss and demyelinating type severe in degree. However, he did not recover from his GBS symptoms, was transferred back to the nursing home and died on 2/15/2021.",Yes,02/14/2021,Not Reported,Yes,10.0,Not Reported,N,12/30/2020,02/01/2021,33.0,SEN,"ACETAMINOPHEN 325 MG TABLET (.) TWO TAB(S) by mouth every 6 hours prn MAXIMUM OF 3.90 GRAMS (3900MG) OF ACETAMINOPHEN PER DAY . *12 TABLETS* dx pain, ACETAMINOPHEN 325 MG TABLET (.) TWO TAB(S) by mouth two times per day (09:00, 17:00) M",Dementia with behavioral disturbances.,1. CAD 2. Leg edema 3. BPH 4. Vascular dementia 5. MDD/behavioral disturbances 6. Sleep wake disturbance 7. Hx BCC posterior neck 8. B/L hips and right knee OA 9. Hyponatremia,Influenza Vaccine,No known allergies.,"['Asthenia', 'Axonal and demyelinating polyneuropathy', 'COVID-19', 'Computerised tomogram spine', 'Death', 'Electromyogram abnormal', 'Guillain-Barre syndrome', 'Immunoglobulin therapy', 'Magnetic resonance imaging brain normal', 'Mental status changes', 'Mobility decreased', 'Movement disorder', 'Polyneuropathy', 'Spinal myelogram normal', 'Urinary tract infection']",1,PFIZER\BIONTECH,IM 1066924,,78.0,F,"Neurology consult 2/13/21: This is a 78-year-old female we were consulted by Dr. for possible guillian barre s/p COVID vaccine. The patient tells me that she was in her normal state of health, and she received her 1st dose of the COVID-19 vaccineseen 7 days ago. Subsequent to that, the next day she developed chills, fatigue that continued for approximately 2 days. She states that 3 days ago, she woke up and was unable to lift her legs or get herself out of bed on her own. She felt weak in her proximal lower extremities and her trunk. She denied any bandlike sensations or paresthesias. She cannot tell me that she developed any distal lower extremity weakness initially but felt that it was the acute onset. She needed some help her out of bed when she was upright, she was able to use her walker to slowly get to the factor. She may have had some urinary incontinence, she does complain of diarrhea now. Denies any tingling sensation, no bulbar symptoms. This is a 78-year-old female who we were asked to evaluate for possible Guillain-Barre syndrome. She had acute onset of lower much greater than upper extremity weakness without any definite ascending features, of relevance, is that she received the COVID-19 vaccine 3 days prior to the onset of her symptoms. She did exhibit flu-like symptoms prior to this. Given that she does not have any specific area of intrathecal enhancement to suggest Guillain-Barre or other areas of radiculitis, I think it is reasonable to proceed with lumbar puncture to look for any other source. --Given the findings on the MRI cervical and lumbar spine including enhancement of the bilateral sacral S1 region, I would like Neurosurgery to further evaluate. -- would likely benefit from CT chest abdomen pelvis to rule out any underlying occult malignancy particularly if workup remains unremarkable. -- continue supportive care, monitor for shortness of breath, new vital capacities Patient remains admitted to the hospital with continued weakness at the time of this report",Not Reported,,Not Reported,Yes,18.0,Not Reported,N,02/06/2021,02/10/2021,4.0,PVT,,,,,,"['Blood albumin increased', 'Blood glucose decreased', 'Blood immunoglobulin G decreased', 'Borrelia test negative', 'CSF myelin basic protein increased', 'Cerebral ischaemia', 'Chills', 'Computerised tomogram abdomen', 'Computerised tomogram pelvis abnormal', 'Computerised tomogram thorax abnormal', 'Diarrhoea', 'Electromyogram normal', 'Electrophoresis normal', 'Fatigue', 'Influenza like illness', 'Intervertebral disc space narrowing', 'Lumbar puncture normal', 'Lymphocyte count increased', 'Lymphocyte percentage increased', 'Magnetic resonance imaging head abnormal', 'Magnetic resonance imaging spinal abnormal', 'Magnetic resonance imaging thoracic abnormal', 'Meningitis bacterial', 'Mobility decreased', 'Monocyte count increased', 'Muscular weakness', 'Nucleated red cells', 'Peripheral sensorimotor neuropathy', 'Physical examination abnormal', 'Protein total increased', 'Red blood cell count increased', 'Scan with contrast', 'Spinal compression fracture', 'Spinal cord compression', 'Viral test negative', 'Walking aid user', 'White matter lesion']",1,PFIZER\BIONTECH,IM 1066942,IL,59.0,M,"2/22/21 positive for covid and flu b 2/23/21 requested bamlanivimab infusion d/t not eating and weakness 2/24/21 emergency room after infusion: HPI 59 y.o. male who presents with left-sided posterolateral chest pain. Pain has been present 4-5 days time. It is worsened by deep inspiration or coughing. The patient has also had nausea and vomiting. Fever has been as high as 101.6�. He was tested and found to be positive for both influenza and COVID-19. He denies anterior or central chest pain dyspnea or orthopnea palpitations sputum production. �3/1/21 emergency room for worsening condition: 59 y.o. male presented to the emergency room with a several day history of intractable nausea vomiting and severe weakness. The patient does have a known history of recent coronavirus (COVID-19) infection. He was diagnosed on February 22nd and did receive Bamlanivimab. He started feeling a little bit better after this, but a few days ago started having increasing weakness and nausea/vomiting. He called me this morning and stated he had been unable will keep anything down for several days and was extremely weak and I asked that he go to the emergency room. In the emergency room is lactic acid was found to be elevated. His CT scan of his chest with contrast showed severe coronavirus (COVID-19) pneumonia. This was run after he was found to have an elevated D-dimer. He was found to be extremely weak and deconditioned. His oxygen saturations at times or found to be in the low 90s. Because of all of this he will be admitted and treated for sepsis from coronavirus (COVID-19).. � 3/2/21 currently remains hospitalized",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/15/2021,02/22/2021,7.0,PUB,"Current Outpatient Medications: ? albuterol 108 (90 Base) MCG/ACT inhaler, Inhale 2 puffs by mouth every 6 hours as needed for Wheezing or Shortness of Breath, Disp: 1 Inhaler, Rfl: 0 ? atorvaSTATin (LIPITOR) 40 MG tablet, TAKE ONE TABLE",,,,nka,"['Alanine aminotransferase decreased', 'Angiogram', 'Aspartate aminotransferase normal', 'Asthenia', 'Blood alkaline phosphatase normal', 'Blood calcium decreased', 'Blood chloride normal', 'Blood creatinine normal', 'Blood glucose increased', 'Blood lactic acid normal', 'Blood magnesium normal', 'Blood potassium normal', 'Blood sodium decreased', 'Blood urea normal', 'COVID-19', 'COVID-19 pneumonia', 'Carbon dioxide decreased', 'Chest X-ray normal', 'Chest pain', 'Computerised tomogram abnormal', 'Cough', 'Decreased appetite', 'Differential white blood cell count normal', 'Fibrin D dimer increased', 'Haematocrit normal', 'Haemoglobin normal', 'Influenza', 'Influenza virus test positive', 'International normalised ratio normal', 'Lipase normal', 'Lung opacity', 'Mean cell volume decreased', 'Nausea', 'Oxygen saturation decreased', 'Painful respiration', 'Platelet count increased', 'Prothrombin time prolonged', 'Pyrexia', 'Red blood cell count normal', 'SARS-CoV-2 test positive', 'Scan with contrast', 'Sepsis', 'Troponin', 'Urine analysis', 'Vomiting', 'White blood cell count normal']",1,MODERNA, 1066945,CA,77.0,F,"Back pain, bilateral lower extremity neuropathy, paresthesias, lower extremity weakness, urinary retention, orthostatic hypotension",Not Reported,,Not Reported,Yes,9.0,Yes,N,02/05/2021,02/18/2021,13.0,UNK,none,none,metastatic melanoma,,none,"['Back pain', 'CSF test abnormal', 'Lymphocytosis', 'Muscular weakness', 'Neuropathy peripheral', 'Orthostatic hypotension', 'Paraesthesia', 'Urinary retention']",1,PFIZER\BIONTECH, 1066947,FL,86.0,M,"Patient daughter notified me that patient started Stivarga on 2/25/2021 (appx). She states that on 2/26/2021 her father started having bloody diarrhea. She states he was ""more fatigued than normal"" leading up to this event. Labs were drawn and it yielded throbocytapenia. She states the oncologists states he does not believe it was from the medication but feels it was the vaccine that produced this. The patient is in the hospital receiving blood and platelet transfusions.",Not Reported,,Yes,Yes,3.0,Not Reported,N,02/11/2021,02/26/2021,15.0,PVT,Stivarga,Stage 4 Colon cancer with mets to liver and lungs,,,Tetnus,"['Diarrhoea haemorrhagic', 'Fatigue', 'Platelet count decreased', 'Platelet transfusion', 'Thrombocytopenia', 'Transfusion']",2,MODERNA,IM 1066973,TN,79.0,F,"2 days later began with headache, dizziness, weakness, on 1/25/21 was admitted to hospital with severe leg weakness, inability to walk, urinary incontinence",Not Reported,,Not Reported,Yes,6.0,Yes,N,01/19/2021,01/21/2021,2.0,PUB,"diclofenac, meclizine, metformin, simvastatin Was seeing a ""doctor"" who prescribed some sort of ""black pills for infection""","c/o stiff, aching neck for ~5 months","Type 2 diabetes mellitus with peripheral neuropathy, HTN, osteoarthritis",,sulfa drugs,"['Asthenia', 'Computerised tomogram head', 'Dizziness', 'Gait inability', 'Headache', 'Laboratory test', 'Lumbar puncture', 'Magnetic resonance imaging head', 'Magnetic resonance imaging neck', 'Magnetic resonance imaging spinal', 'Muscular weakness', 'Neurological examination', 'Urinary incontinence']",1,MODERNA,IM 1066974,MN,54.0,F,Admitted to Hospital on 2/25/21 with 1 day of severe upper extremity weakness and numbness. Evaluated by Neurology and Neurosurgery teams and thought to be most consistent with transverse myelitis. Infectious Diseases consult and no clear preceding infectious illness.,Not Reported,,Not Reported,Yes,,Yes,N,02/09/2021,02/25/2021,16.0,WRK,,had first dose of Shingrix vaccine on 1/21/21,,,,"['HIV test negative', 'Hepatitis viral test negative', 'Hypoaesthesia', 'Muscular weakness', 'Myelitis transverse']",1,MODERNA,IM 1066985,NJ,35.0,M,"New onset headache, seizures, and encephalopathy",Not Reported,,Not Reported,Yes,,Not Reported,N,02/04/2021,02/25/2021,21.0,UNK,Metaxalone 800mg Dexilant 60mg Finasteride 5mg,No,GERD AND BPH,,NKA,"['Electroencephalogram abnormal', 'Encephalopathy', 'Headache', 'Seizure']",UNK,MODERNA, 1067023,CA,68.0,M,Super bad Vertigo,Not Reported,,Not Reported,Not Reported,,Yes,N,02/26/2021,02/28/2021,2.0,PVT,None,None,None,,None,"['Blood test', 'Electrocardiogram', 'Magnetic resonance imaging', 'Urine analysis', 'Vertigo', 'X-ray']",2,MODERNA,IM 1067036,HI,88.0,M,Patient received dose 1 of Moderna Vaccine on 1/14/21 administered by pharmacy. Patient was hospitalized on 1/31/21 due to shortness of breath and diminished O2 sats down to 88%. Patient was in atrial fibrillation. Patient discharged from hospital on 2/25/21 to home. Patient received dose 2 of Moderna Vaccine on 2/25/21 prior to discharge from hospital. Last hospital note stated that patient was pleasant and cooperative with good motivation. Patient passed away after discharge from the hospital on 2/26/21. Patient's son called the hospital to report his passing.,Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,N,02/25/2021,02/26/2021,1.0,PVT,,Patient was discharged from the hospital to a home on 2/25/21 after a complicated 25 day hospitalization.,"history of hypertension, diabetes mellitus, history of chronic AFib, on anticoagulation, history of MI with a stent, history of BPH, history of dementia, chronic kidney disease, GERD and benign essential tremor, who was at a nursing home",,"lisinopril, metoprolol","['Death', 'Dyspnoea', 'Oxygen saturation decreased', 'Respiratory distress']",2,MODERNA,SYR 1067056,CA,81.0,M,"Received first dose of covid vaccine on 2/15/2021, then hospitalized later that day with Covid PNA",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,02/15/2021,02/15/2021,0.0,PVT,"losartan-hctz, atenolol,, amlodipine, metformin",none,"DM2, CKD, dyslipemia, htn, obesity",,none,"['COVID-19', 'COVID-19 pneumonia']",1,PFIZER\BIONTECH,IM 1067083,MA,49.0,M,"Early Wednesday morning (2/24) around 5:00AM, I woke up to extreme pain in my left arm, primarily along the upper forearm, inside of my elbow, and lower bicep. There was no trauma or unusual behavior prior to onset of pain. It came on suddenly and worsened with extension of the arm. Symptoms worsened over the next few days, with pain intensifying and extending down into my hand and up into my armpit and shoulder. I tried ice, Ibuprofen, Acetaminophen, and Vicodin for pain relief, but nothing really helped other than the ice. On Saturday morning (2/27), I visited Urgent Care and was diagnosed as brachial plexis neuritis, aka Parsonage-Turner Syndrome by Dr and prescribed Prednisone and rest. On Sunday evening (2/28), I went to the ER seeking pain relief and second opinion. On Monday (3/1) morning, I was seen by ED doctors, and then three different neurologists. After doing an ultrasound which ruled out vein/artery thrombosis, the neuro team diagnosed Parsonage-Turner Syndrome. They've prescribed Gabapentin, Acetaminophen, and Ibuprofen for pain relief, a follow-up neuro consult, an MRI for next Friday, and an EMG in a few weeks. Last night while sitting and reading, the same pain began in my right arm, similarly to how it presented in my left arm last week. The right arm pain is less than the left arm pain, but at this point seven days later, I am experiencing neuropathic pain in both arms.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/23/2021,02/24/2021,1.0,PUB,None,None,None,,None,"['Abnormal behaviour', 'Arthralgia', 'Axillary pain', 'Blood test', 'Injection site pain', 'Neuralgic amyotrophy', 'Pain', 'Pain in extremity', 'Ultrasound Doppler normal', 'Ultrasound scan normal', 'X-ray']",1,PFIZER\BIONTECH,SYR 1067086,RI,65.0,F,"Guillain-Barre Syndrome. 3-day hospitalization, IVIg infusion. Symptoms of tingling feet (started in toes and progressed to whole foot), lower leg weakness and fatigue began 16 days post vaccination. Hospitalization 4 days post symptom onset.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/27/2021,02/12/2021,16.0,SEN,"Armour thyroid, Trazedone, QVAR inhaler, Nasonex, melatonin, multi-vitamin, turmeric, vitamin D",none,hypothyroid,,NKA,"['Blood test', 'Fatigue', 'Guillain-Barre syndrome', 'Immunoglobulin therapy', 'Muscular weakness', 'Neurological examination', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 1067090,NY,97.0,F,"within 24 hours after her second injection she developed chills, had a syncopal episode and had, difficulty breathing. this progressed over the next day when she had a second syncopal episode and her dyspnea and confusion worsened EMT was called and she was brought to the hospital. she was in flash pulmonary edema and with her history of severe aortic stenosis she was admitted to the cardiac icu. she had no prior history up to that time of pulmonary edema and was functioning without distress in her home. she had a history of covid in early april, manifesting primarily as severe confusion, from which she recovered.",Yes,02/25/2021,Yes,Yes,6.0,Not Reported,N,02/17/2021,02/18/2021,1.0,SEN,metoprolol nifedipine asa vitamin d preservision eye vitamin escitalopram 5 mg latanoprost eye drop qhs to left eye,aortic stenosis severe mild hypertension peripheral vascular disease stable,aortic stenosis glaucoma macular degeneration mild hypertension senile dementia,,none,"['Acute pulmonary oedema', 'Aortic stenosis', 'Chest X-ray', 'Chills', 'Computerised tomogram', 'Condition aggravated', 'Confusional state', 'Dyspnoea', 'Echocardiogram', 'Intensive care', 'Syncope']",2,PFIZER\BIONTECH,IM 1067095,CA,89.0,F,"first dose of vaccine on 2/11/2021, then hospitalized with covid pneumonia on 2/15/2021",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/11/2021,02/15/2021,4.0,PVT,"aspirin, metoprolol, gabapentin, atorvastatin, losartan, warfarin",no,"afib, cad, ckd, dementia, htn, dyslip,",,Lisinopril,['COVID-19 pneumonia'],1,PFIZER\BIONTECH,IM 1067115,NY,93.0,F,"Foot pain 1 day after, 2 days after weak, and short of breath with cough; went to ED. Admit for CHF",Not Reported,,Not Reported,Yes,,Not Reported,U,02/28/2021,03/01/2021,1.0,UNK,"xarlto,norvasc, hctz, cor, amitriptyline",,afib,,penicillin,"['Asthenia', 'Brain natriuretic peptide increased', 'Cardiac failure congestive', 'Cough', 'Dyspnoea', 'Pain in extremity']",2,MODERNA, 1067125,TX,86.0,M,"was reported to staff at Health Department that client passed away hours after receiving Moderna vaccine, also reported that client had multiple health conditions.",Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,,02/26/2021,02/26/2021,0.0,OTH,,,,,,['Death'],UNK,MODERNA,IM 1067134,CA,70.0,M,received first dose of covid vaccine on 2/2/2021. Then hospitalized with covid disease / pneumonia on 2/12/2021,Not Reported,,Not Reported,Yes,20.0,Not Reported,N,02/02/2021,02/12/2021,10.0,PVT,"levothyroxine, metoprolol, omeprazole, sildenafil, duloxetine, simvastatin, tamsulosin,",,"htn, dyslipidemia, GERD, OSA",,"amlodipine, pepcid","['COVID-19', 'COVID-19 pneumonia']",1,MODERNA,IM 1067143,CO,34.0,F,"On 02.24.21 in the evening I began experiencing body aches. The following day I had a fever of 100.8 and saw an Urgent Care provider who referred me to the hospital. Upon arrival my fever spiked to 102.3, bloodwork showed elevated lactate at 2.4 and pulse rate was over 119. I was admitted with sepsis symptomatology.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,02/14/2021,02/24/2021,10.0,PVT,,None,None,,L-Lysine - 1500mg Vitamin C - 100mg Garlic Bulb - 200mg Echinacea - 100mg Propolis - 25mg Licorice Root - 15mg,"['Blood calcium increased', 'Blood lactic acid increased', 'Blood potassium decreased', 'C-reactive protein increased', 'Glomerular filtration rate decreased', 'Glomerular filtration rate increased', 'Heart rate increased', 'Pain', 'Pyrexia', 'Sepsis', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1067147,MO,55.0,M,"The afternoon following administration of the vaccine he began to experience chest pains. The chest pains continued throughout the rest of the day and throughout the night prompting him to present to the Hospital Emergency Department where he was noted to have a mildly elevated troponin and was admitted to the hospital. His troponins returned to normal and he was discharged with an appointment for outpatient coronary angiogram. Of note, he did have a Covid19 infection last fall several months prior to vaccination.",Not Reported,,Yes,Yes,2.0,Not Reported,Y,02/20/2021,02/21/2021,1.0,PVT,none,none,none,,clindamycin,"['Chest pain', 'Troponin increased']",UNK,MODERNA,IM 1067177,PA,93.0,F,Patient had sudden death 1 week after 2nd COVID vaccine. Had complained of dizziness throughout the week leading up to it.,Yes,02/27/2021,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/27/2021,7.0,PVT,,,"diabetes, hypertension, hypothyroidism, osteoporosis, chronic kidney disease",,"actonel, aspirin, bextra, celebrex, iodine, novacaine, penicillin, sulfa","['Dizziness', 'Sudden death']",2,MODERNA, 1067251,OR,69.0,F,"she got the shot on 1/31/2021. Over the next 3 days she developed poor oral intake and diarrhea every 15 minutes; required hospitalization on 2/3/2021. Was hospitalized at Hospital. Hospital course was complicated by sepsis, pressors, intubation, GI bleed with ruptured rectum requiring surgery (ostomy). anticipated discharge 3/3/2021.",Not Reported,,Yes,Yes,28.0,Yes,Y,01/31/2021,02/03/2021,3.0,PVT,"revlimid 25mg started 1/12/2021), saphris, atorvastatin, citracal, Tylenol #3, denosumab (given 8/2020), lisinopril, lidocaine patch, diclofenac gel, sertraline 150mg, omeprazole, aleve, lorazepam.",developed diarrhea and poor PO intake on 1/31 - thought related to lenalidomide (revlimid). admitted to hospital on 2/3/2021 after days of severe diarrhea resulting in dehydration and acute renal failure.,"remote h/o breast cancer with mastectomy, ongoing treatment for multiple myeloma, HTN, osteoporosis, schizophrenia and PTSD",,"oxycontin,","['Acute kidney injury', 'Blood creatinine increased', 'Blood sodium decreased', 'Colorectostomy', 'Decreased appetite', 'Dehydration', 'Diarrhoea', 'Endotracheal intubation', 'Gastrointestinal haemorrhage', 'Haematocrit decreased', 'Hypophagia', 'Paradoxical pressor response', 'Platelet count decreased', 'Post-traumatic stress disorder', 'Protein total decreased', 'Rectal injury', 'Sepsis', 'White blood cell count decreased']",UNK,PFIZER\BIONTECH,IM 1067296,NV,45.0,F,"Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to sleep and shortness of breath. In addition, swollen and painful lymph glands under both arms but worse in injection arm.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/01/2021,02/18/2021,17.0,PVT,None,None,Exercise-induced Asthma Endometriosis,Difficulty breathing with first dose; dizziness,"Morphine, Hydrocodone, Percocet, Tramadol, Motrin, Doxycycline, Erythromiacin","['Asthenia', 'C-reactive protein increased', 'Dyspnoea', 'Lymph node pain', 'Lymphadenopathy', 'Lymphocyte count decreased', 'Neutrophil count increased', 'Oxygen saturation decreased', 'Red blood cell sedimentation rate increased', 'Sleep disorder', 'White blood cell count']",2,PFIZER\BIONTECH,IM 1067328,CA,74.0,M,"disorientation, loss of memory and confusion.",Not Reported,,Not Reported,Yes,,Not Reported,N,03/02/2021,03/02/2021,0.0,PVT,"Alfuzosin HCL 10mg, Cholecalcif 25mg, Mirtazapine 15mg take 1/2 daily,",suspicion of beginning stages of dementia or Alzheimer's no confirmation yet,has a pace maker for 2 years but has not had any issues with it,,,"['Amnesia', 'Blood test', 'Computerised tomogram', 'Confusional state', 'Disorientation']",UNK,MODERNA, 1067358,TX,64.0,M,"1-25-2021- Phone call: pt had cold and cough prior to vaccine. cough worsened 1-28-2021 Phone call: pt requesting provider visit, cough is same and taking tessalon pearls 1-29-2021 Provider in office visit: pt complain of cough and SOB for 6 days. Getting worse. Temp 101.2, pulse ox 87%, BP 128/70. level of distress- leaning forward to breath. appeared ill. diffuse rales throughout both lung fields, more at bases. Diagnosis Pneumonia due to COVID 19 virus. Sent to ER",Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/25/2021,2.0,PVT,Tessalon Perles 100 mg Tivicay 50mg ibuprofen 400mg cimduo 300mg peridex 0.12% mouthwash augmentin 500mg-125mg zyrtec 10mg Flonase allergy relief 50mcg diclofenac 1% topical gel,Mild respiratory symptoms with cough,HIV Obesity,,Acetaminophen,"['Body temperature increased', 'COVID-19', 'COVID-19 pneumonia', 'Cough', 'Dyspnoea', 'Emotional distress', 'Malaise', 'Pneumonia', 'Rales', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1067377,FL,86.0,M,"Transverse myelitis, leg weakness, bladder/bowel dysfunction. Hospitalized, still recovering.",Not Reported,,Not Reported,Yes,9.0,Yes,N,02/05/2021,02/01/2021,,PHM,"Coumadin, thyroid replacement, hypertension drugs, vit supplements, flomax",Sinus infection,"Hypertension, COPD, PAD, hypothyroid, BHP.",,Nkda,"['Bladder dysfunction', 'Functional gastrointestinal disorder', 'Magnetic resonance imaging', 'Muscular weakness', 'Myelitis transverse']",1,MODERNA,IM 1067385,MI,68.0,M,Paralysis of face,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/28/2021,5.0,PVT,,,,,,['Facial paralysis'],UNK,PFIZER\BIONTECH, 1067393,KY,27.0,F,"Fatigue, headache, chest pains, side pains, stomach cramps, ovary aches, high blood pressure",Not Reported,,Yes,Yes,3.0,Not Reported,N,02/13/2021,02/14/2021,1.0,SCH,"Synthroid 50 mg., Valacyclovir 1 gram, Adderall 20 mg., Junel Fe 120, Vitamin D & E, Cymbalta 90 mg.",None,,,,"['Abdominal pain upper', 'Adnexa uteri pain', 'Blood test abnormal', 'Chest pain', 'Computerised tomogram abnormal', 'Fatigue', 'Flank pain', 'Headache', 'Hypertension', 'Kidney infection', 'Pancreatitis', 'Urine analysis abnormal']",2,MODERNA,SYR 1067404,WI,41.0,F,"Red, warm, swollen, tender on arm for 2 weeks. Went in on 1/14/21 for muscle weakness, numbness, and muscle spasms. Stuttering verbally started 1/27/21 and has not stopped. Muscle spasms, muscle weakness and fatigue have increased drastically from date of injection til now, tremors all over in the body, when laying down to rest extremities at different times will involuntary jump. Had itching all over with no rash since 2nd week in February.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/08/2021,01/27/2021,19.0,PVT,"Duloxitine, wellbutrin, topiramate, pramipaxole, vitd, magnesium",None,"Fibromyalgia, migraines, GERD,PUD,IBS,depression, arthritis",,"Penicillin, aspirin, ibuprofen","['Dyskinesia', 'Dysphemia', 'Erythema', 'Fatigue', 'Hypoaesthesia', 'Laboratory test normal', 'Magnetic resonance imaging normal', 'Muscle spasms', 'Muscular weakness', 'Peripheral swelling', 'Pruritus', 'Skin warm', 'Tenderness', 'Tremor']",1,MODERNA,IM 1067420,VA,79.0,F,"Second dose of Covid vaccine given on 2/7/21. Administered at central location. Taken to hospital for possible stroke like symptoms with drooping to right eye and mouth, difficulty swallowing, and feeling odd. Admitted and treated from 2/18/21 thru 2/22/21.",Not Reported,,Not Reported,Yes,5.0,Yes,N,02/07/2021,02/17/2021,10.0,PVT,"Asprin, Atorvastatin, Candesartan, Metformin, Lamotrigine, Venlafaxine, Memantine, Omeprazole, Thiamine",None other than longstanding illnesses listed below,"Dementia, high blood pressure, depression/anxiety, Type II diabetes, pacemaker",,"egg allergy, penicillin","[""Bell's palsy"", 'Dysphagia', 'Facial paralysis', 'Feeling abnormal']",2,PFIZER\BIONTECH,IM 1067435,,71.0,M,"Acute congestive heart failure, unspecified heart failure type; Acute on chronic diastolic heart failure; Atrial fibrillation with RVR; CHF (congestive heart failure); Chest pain; Shortness of breath",Not Reported,,Not Reported,Yes,2.0,Not Reported,,02/26/2021,02/26/2021,0.0,PVT,,,,,ACE INHIBITORS; BENAZEPRIL; LISINOPRIL,"['Acute left ventricular failure', 'Atrial fibrillation', 'Cardiac failure', 'Cardiac failure acute', 'Cardiac failure congestive', 'Chest pain', 'Chronic left ventricular failure', 'Dyspnoea', 'Left ventricular failure']",2,MODERNA,IM 1067448,,22.0,M,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/01/2021,03/03/2021,2.0,UNK,,,,,,['Unevaluable event'],UNK,JANSSEN, 1067470,AR,65.0,F,day 1 of vaccine pain swelling redness at the site chills 1-8-21 day 7 continued swelling of L deltoid size of handball chills continue swelling of lymph nodes in L axilla fatigue 1-28-21 developed strong chest pain substernal to L scapula x 7 hours went to er admitted to hospital elevated d dimer ct of chest nothing acute ekg nothing acute lab work up for evaluation of heart normal continued swollen lymph nodes L axilla swelling of deltoid gone discharge from Hospital after 1 day 2-5-21 had episodes of chest pain relived by rest 4-5 x a day since 1-28-21 unable to work due to chest pain swelling of lymph nodes in L axilla continue fatigue repeated episode of chest pain on 2-5-21 lasting 2 hours went back to hospital monitered for 1 day stress test and echocardiogram normal. 3-2-21 continue to have chest pain with activity ie walk 20-30 ft taking a shower have had chest pain 4-5 x daily since 1-28-21,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,"levothyroxine, losartan, hctz, singulair, advir discus, multivite, tumeric, tylenol",hypothyroid asthma htn,hypotyroid asthma htn,30 yo Hep B vaccine 103 fever,"red dye #5, thimerosal, adhesive tape, cat dander, hep c vaccine","['Cardiac monitoring', 'Cardiac stress test', 'Cardiac stress test normal', 'Chest X-ray normal', 'Chest pain', 'Chills', 'Computerised tomogram thorax normal', 'Echocardiogram normal', 'Electrocardiogram normal', 'Fatigue', 'Fibrin D dimer increased', 'Fibrin D dimer normal', 'Impaired work ability', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Lymphadenopathy', 'Troponin normal']",1,MODERNA,IM 1068425,IL,47.0,F,"2/05 fever,chills, body aches x 1day-no treatment 2/06 fell getting out of bed(off balance) no treatment Since shot noticed daily body aches in neck ,back. Short of air with exertion, fatigue. Week of 2/22 face and hands swelling 02/23 memory lapse at work 2/28 during yard work passed-out followed by fatigue 03/01 found unconscious for several hours, still in the hospital today.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/04/2021,02/05/2021,1.0,PVT,Sertraline 100mg Clonazepam 0.5mg Atenolol 50mg Spironolactone/HCTZ Levothyroxine 50mg Ergocalceferal 1.25mg Tizanidine 4mg Losartan 100mg,Sinus imfection,"HTN, Cushing Disease remission( surgery pituitary 09/03/20, had COVID Oct 2020, Depression, anxiety",,None,"['Amnesia', 'Asthenia', 'Back pain', 'Balance disorder', 'Chills', 'Dyspnoea', 'Dyspnoea exertional', 'Fall', 'Fatigue', 'Loss of consciousness', 'Neck pain', 'Pain', 'Peripheral swelling', 'Pyrexia', 'Swelling face']",7+,MODERNA,SYR 1068743,TN,,M,"Bamlanivimab treatment under Emergency Use Authorization(EUA): Bamlanivimab treatment under Emergency Use Authorization(EUA). Patient received 1st dose of COVID vaccine on 01/28/2021, but he began to have COVID symptoms on 02/04/2021 and tested positive on 02/05/2021. The patient was treated with banlanivimab on 02/08/2021, and he passed away on 02/09/2021.",Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,,,02/09/2021,,UNK,Bamlanivimab; Aspirin; Lumigan; Citracal + D3; Chondroitin sulfate a; gabapentin; ipratropium; levothyroxine; losartan; metoprolol; multivitamin; nitroglycerin; fish oil; ranolazine; viagra; simvastatin; maxzide,,"allergic to iodine and naproxen. past medical history including hypertension, type 2 diabetes, bladder cancer, hypothyroidism, coronary artery disease, 2 heart attacks, prostrate cancer, and vitamin d deficiency.",,,"['Death', 'SARS-CoV-2 test positive']",1,UNKNOWN MANUFACTURER,IM 1068761,,82.0,M,"DEATH Narrative: patient was placed on hospice care following vaccine, unclear cause of death, not documented",Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,02/06/2021,25.0,OTH,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1068762,,76.0,M,"DEATH Narrative: patient's wife reported he had gone in an outside hospital, had held his brilinta as advised anticipating shoulder surgery ""and he threw a big clot and died.""",Yes,03/02/2021,Not Reported,Not Reported,,Not Reported,N,01/11/2021,03/02/2021,50.0,OTH,,,,,,"['Death', 'Thrombosis']",1,PFIZER\BIONTECH,IM 1068882,,85.0,M,"DEATH Narrative: Son stated that patient was doing well, still working and driving places. He stated that he called his son and stated that he wasn't feeling well and died shortly after that.",Yes,01/29/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/29/2021,17.0,OTH,,,,,,"['Death', 'Malaise']",1,MODERNA,IM 1068883,,89.0,M,DEATH Narrative: PATIENT PASSED AWAY WHILE ON HOSPICE CARE,Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,12/31/2020,02/05/2021,36.0,OTH,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1068884,,85.0,M,"DEATH Narrative: Presented to ED via EMS c/o increasing shortness of breath, O2 sat mid to high 80s on 4L. When EMS arrived , pt was in distress, intubated by EMS and transported to ED. Pt had a PEA arrest en route but resuscitated w/ return of spontaneous circulation after receiving a dose of epinephrine and chest compressions. Pt was hypotensive on arrival to ED. He was started on sepsis protocol , volume resuscitation and empiric antibiotics. Once stabilized, he was admitted to icu at hospital. Removed from respirator 2/22/21",Yes,02/22/2021,Not Reported,Yes,,Not Reported,N,02/08/2021,02/22/2021,14.0,OTH,,,,,,"['Cardioversion', 'Death', 'Dyspnoea', 'Endotracheal intubation', 'Hypotension', 'Intensive care', 'Pulseless electrical activity', 'Respiratory distress', 'Resuscitation', 'Sepsis']",2,PFIZER\BIONTECH,IM 1068885,,98.0,M,"DEATH Narrative: PRIOR TO DEATH, spoke with pt's daughter and she reported that pt is unable to keep his appt for the second Covid vaccine appt because is sick today. Per daughter, pt has been lethargic, not enough sleep last night because of frequent urination at least every 30 to 45 minutes looks exhausted and with poor appetite. Pt has not been drinking fluids at least 6 to 8 glasses a day and daughjter tries to make sure pt drinks fluids, the best he can. Per daughter, pt's vitals signs are as follows: BP: 93/48mmhg PR: 93/min. Temp: 98.1 F and O2 sat: 95%.",Yes,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,02/17/2021,33.0,OTH,,,,,,"['Death', 'Decreased appetite', 'Fatigue', 'Illness', 'Incomplete course of vaccination', 'Insomnia', 'Lethargy', 'Malaise', 'Nocturia', 'Pollakiuria']",1,MODERNA,IM 1068886,,67.0,M,"DEATH Narrative: Pt he reports he developed chills SOB body aches the same night as receiving the COVID vaccine on 1.26.2021-pt is currently reporting CheSt tightness and SOB Admitted to hosp: ICU with Bilateral Pulmonary Emboli, LLE DVT, NSTEMI, Arrhythmia.",Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,OTH,,,,,,"['Acute myocardial infarction', 'Arrhythmia', 'Chest discomfort', 'Chills', 'Death', 'Deep vein thrombosis', 'Dyspnoea', 'Intensive care', 'Pain', 'Pulmonary embolism']",1,PFIZER\BIONTECH,IM 1068887,,90.0,M,"DEATH Narrative: UNSURE DETAILS OF EVENT, NO DOCUMENTATION IN PROGRESS NOTES",Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,02/13/2021,38.0,OTH,,,,,,['Death'],1,MODERNA,IM 1068888,,88.0,M,DEATH,Yes,02/27/2021,Not Reported,Not Reported,,Not Reported,N,02/26/2021,02/27/2021,1.0,OTH,,,,,,['Death'],1,MODERNA,IM 1067888,PR,35.0,F,"I've had too much stomach upset; Severe heartburn; Persistent mouth dryness; The taste in my mouth changed; Extreme fatigue; This is a spontaneous report from contactable healthcare professional. A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 27Jan2021 09:15 at single dose (left arm) for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. The patient was not pregnant. There were no concomitant medications. The patient had no other vaccine in other 4 weeks. On 28Jan2021, at 12:00, the patient experienced too much stomach upset, severe heartburn, persistent mouth dryness, the taste in mouth changed and extreme fatigue. The patient received therapy for the events included household medication and natural treatment. The patient did not have covid prior vaccination and was not covid tested post vaccination. Outcome of events was not recovered. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/28/2021,1.0,UNK,,,,,,"['Abdominal discomfort', 'Dry mouth', 'Dyspepsia', 'Fatigue', 'Taste disorder']",1,PFIZER\BIONTECH, 1067889,PR,,U,"Fatigue; muscle aches; headache; This is a spontaneous report from a contactable consumer (the patient). A patient of an unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. On an unspecified date after the second dose, the patient experienced fatigue, muscle aches, and headache. The clinical outcome of fatigue, muscle aches, and headache was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Fatigue', 'Headache', 'Myalgia']",2,PFIZER\BIONTECH, 1067933,MD,58.0,M,"103 degree fever; chills; body aches; headache; feeling hot through the night; Got sick; This is a spontaneous report from a contactable consumer (the patient). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided, expiry date May2021), via an unspecified route of administration in the left arm on 30Jan2021 10:00 (at the age of 58-years-old) as a single dose for COVID-19 immunization; and apixaban (ELIQUIS, lot number ABA8272S, NDC 0003089421, expiry date Oct2021) film-coated tablet, via an unspecified route of administration from an unspecified date to 31Jan2021 at 5 mg, twice daily for cerebrovascular accident prophylaxis. Medical history included: he had tested positive asymptomatically for COVID due to contact contamination on 02Jan2021 or 03Jan2021, blood pressure, and A-fib (atrial fibrillation). Concomitant medication included ongoing metoprolol for blood pressure. There were no vaccines administered on same date with the Pfizer vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated that he got sick after getting the vaccine (on 30Jan2021) and had an important question. He got a fever (31Jan2021) and all that stuff that lasted like a day and a half after getting the vaccine, just like a million other people. But he missed the part about asking a doctor about taking his blood thinner, which he took as normal up through the day that he got the vaccine and the next morning, then he stopped it. The patient clarified that he got the vaccine on Saturday (30Jan2021), stopped the blood thinner on Sunday (31Jan2021), the sickness subsided around Monday (as reported), but he still hasn't gone back on the blood thinner. He wanted to know when it was safe for him to start taking the blood thinner again, and he needed to know what to do for the second vaccine. The clinical course was as follows: He got the first dose of the vaccine on 30Jan2021 at 10:00 and at 22:00 he started feeling hot through the night. On Sunday, 31Jan2021, he had 103 degree fever, chills, body aches, and a headache. He clarified that he recovered completely by Wednesday, 03Feb2021. He had been on Eliquis for years for A-Fib. He stopped taking it once he got sick after getting the vaccine and went back and read the material and noticed what it said about the blood thinner. He did not go to the emergency room or physician's office. The action taken in response to the events for apixaban was temporarily withdrawn. The outcome of the events was recovered on 03Feb2021. Follow-up (05Feb2021): This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-013684), license party for apixaban (ELIQUIS). This case was received via Pfizer Inc (Reference number: #) on 05Feb2021 and was forwarded to BMS on 09Feb2021. This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (103 degree fever), CHILLS, PAIN (bodyaches) and HEADACHE in 58-year-old male patient who received apixaban (Eliquis) film-coated tablet (batch no. ABA8272S) for Cerebrovascular accident prophylaxis. CO-SUSPECT PRODUCTS included Covid-19 Vaccine injection for COVID-19 immunisation. Concurrent medical conditions included Blood pressure abnormal. On an unknown date, the patient started Eliquis (batch no. ABA8272S) (unknown route), 5 milligram twice a day. On 30Jan2021, the patient started Covid-19 Vaccine (unknown route) Unknown dose by injection in left arm. On 31Jan2021, an unknown time after starting Eliquis, the patient experienced PYREXIA (103 degree fever), CHILLS, PAIN (bodyaches) and HEADACHE. Eliquis (Unknown) was interrupted due to event. On 03Feb2021, PYREXIA, CHILLS, PAIN and HEADACHE resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31Jan2021, Body temperature: 103 degree. For Eliquis (Unknown), the reporter did not provide any causality assessments. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/30/2021,0.0,UNK,METOPROLOL,,Medical History/Concurrent Conditions: Asymptomatic COVID-19 (tested positive asymptomatically for covid due to contact contamination on 02Jan2021 or 03Jan2021); Atrial fibrillation; Blood pressure abnormal,,,"['Body temperature', 'Chills', 'Feeling hot', 'Headache', 'Illness', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1067934,FL,65.0,M,"Dizziness; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-016013), license party for apixaban (ELIQUIS). This case was received via Pfizer Inc (Reference number: 2021162914) on 15-Feb-2021 and was forwarded to BMS on 16-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of dizziness in 65-year-old male patient who received apixaban (ELIQUIS) for venous thromboembolism. Co-suspect products included covid-19 vaccine for covid-19 immunisation. Patient weight was reported as approximately between 185-190 (Units not specified). The patient's past medical history included Open heart surgery (had two open heart surgeries. Believes first one was 2002 or 2004, second was 5 years ago, sometime in 2016) and COVID-19 in November 2020. Concurrent medical conditions included Diabetes and Coronary artery disease in 2002. In November 2020, the patient started ELIQUIS (unknown route), 5 milligrams twice a day. On 14-Feb-2021, the patient started covid-19 vaccine (unknown route). On the same day, the patient experienced dizziness. The dose of ELIQUIS (unknown) was not changed. At the time of the report, dizziness did not resolve. For ELIQUIS (unknown), the reporter did not provide any causality assessments. About three hours after getting covid shot patient felt dizziness. It was like he was disoriented or something. It was like his equilibrium was off. He was off balance with it. He is not 100 percent balanced. Patient got Flu Shot, Pneumonia shot previously. No prior vaccinations within 4 weeks. Further follow up was not performed, as sufficient data reported. Causality Assessment: Drug: ELIQUIS Dizziness Per Reporter = No Information Per Company (Bristol-Myers Squibb) = Related",Not Reported,,Not Reported,Not Reported,,Not Reported,N,11/01/2020,02/14/2021,105.0,UNK,ENTRESTO; RANOLAZINE EXTENDED RELEASE; DIGOXIN; ROSUVASTATIN; CLOPIDOGREL; ISOSORBIDE; PREGABALIN; AMLODIPINE; METOPROLOL; FENOFIBRATE; PANTOPRAZOLE; GLIPIZIDE; METFORMIN HYDROCHLORIDE; ROPINIROLE HYDROCHLORIDE; FUROSEMIDE; ACETAMINOPHEN AN,Coronary artery disease; Diabetes,"Medical History/Concurrent Conditions: COVID-19; Open heart surgery (had two open heart surgeries. Believes first one was 2002 or 2004, second was 5 years ago, sometime)",,,"['Dizziness', 'Weight']",UNK,PFIZER\BIONTECH, 1067935,MA,,F,"increased need for oxygen; difficulty breathing; A spontaneous report was received from a consumer concerning a 85 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events needing additional oxygen (PT: Hypoxia) and difficulty breathing (PT: Dyspnoea). The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Jan 21, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for the COVID-19 infection prophylaxis. On an unknown date, the patient experienced increase difficulty breathing and increased need for oxygen. Treatment included oxygen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, needing additional oxygen and difficulty breathing, were unknown/not reported.; Reporter's Comments: This case concerns an 85-year-old female who experienced a serious unexpected event of HYPOXIA along with a nonserious unexpected event of DYSPNOEA. The events occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (NO reported medical history),,,"['Dyspnoea', 'Hypoxia']",1,MODERNA,OT 1067936,OH,55.0,M,"acute adrenal crisis; A spontaneous report was received from a Physician regarding his son who received second dose of Moderna Covid-19 vaccine and have experienced acute adrenal crisis. The patient's medical history was not provided. His concomitant medications were not provided. No information on allergies. On 11-FEB-2021, prior to the onset of events, the patient received second of two planned doses of Covid-19 vaccine for the prophylaxis of Covid-19 infection. Patient lives in a group home. On an unspecified date, he seemed to be confused, disoriented and unable to talk. Father met him at Emergency department where the patient had an acute adrenal crisis , and after ruling out stroke ,he was diagnosed with Addison's disease(loss of adrenal function). He was admitted and discharged after two days. Post discharge, he seemed totally normal. Action taken with the vaccine is not applicable as the patient received both the doses. The outcome of the event acute adrenal crisis is considered recovered at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/11/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Adrenocortical insufficiency acute'],2,MODERNA,OT 1067937,,,U,"Sepsis; A spontaneous report was received from a consumer of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sepsis. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, the patient received a dose (first or second dose not specified) of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. On an unknown date, the patient was reportedly rushed to the hospital for sepsis (details not provided). Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, sepsis was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Sepsis'],1,MODERNA,OT 1067938,,,U,"Developed PMR; negative effect; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events( vaccination complication i.e., polymyalgia rheumatica) list. The patient's medical history was not provided. No relevant concomitant medications were reported. on unknown date, prior to the onset of the events, the patient received mRNA vaccine for prophylaxis of COVID-19 infection. on unknown date, the patient experienced the events list (polymyalgia rheumatica) with seriousness criteria. Laboratory details are not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event was not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Polymyalgia rheumatica', 'Vaccination complication']",1,MODERNA,OT 1067939,,,M,"bloody stools; A spontaneous report was received from an unknown reporter concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273), experienced bloody stools for 2 days. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 05-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) for prophylaxis of COVID-19 infection. Patient reported to the nurse at his second Moderna vaccine appointment that he had bloody stools for 2 days, and then the bloody stools stopped. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The event, blood stools for 2 days , was recovered/resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Haematochezia'],1,MODERNA,OT 1067940,MI,68.0,F,"Passed out and fell on the bathroom floor; didn't feel well; Passed out and fell on the bathroom floor; Nauseated; Arm was sore; A spontaneous report was received from a consumer concerning a 68-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced arm was sore, nauseated, didn't feel well, passed out and fell on the bathroom floor. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, the patient experienced sore arm, not feeling well, nausea, passed out and fell on the bathroom floor. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events arm was sore, nauseated, didn't feel well, passed out and fell on the bathroom floor were unknown.; Reporter's Comments: This case concerns a 68-year-old female who experienced serious unexpected events of Loss of consciousness, along with nonserious unexpected malaise and fall and NS expected vaccination site pain and nausea. The events occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/13/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Fall', 'Loss of consciousness', 'Malaise', 'Nausea', 'Vaccination site pain']",1,MODERNA,OT 1067941,CT,48.0,F,"Blood pressure 170/120; Fast heart rate; Rash on her arm that spread across her body, rash felt itchy and hot; Rash felt itchy and hot; Headache; A spontaneous report was received from a consumer concerning, a 48-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fast heart rate, BP:170/120, rash spread from arm to her body, rash felt hot and headache. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Jan 2021, 1 day prior to onset of the events fast heart rate, BP:170/120, rash spread from arm to her body, rash felt hot and headache, patient received their dose of mRNA-1273 (lot/batch: 029L420A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient had medically significant events of increased heart rate, BP:170/120, rash spread from arm to her body, rash felt itchy and hot and non serious event of headache. The patient stayed at the ER (emergency room) for 3 hours. Treatment included diphenhydramine. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events increased heart rate, BP:170/120, rash spread from arm to her body, rash felt itchy and hot was recovered on 22 Jan 2021. The outcome of the event headache was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history .),,,"['Feeling hot', 'Headache', 'Heart rate increased', 'Hypertension', 'Rash pruritic']",UNK,MODERNA,OT 1067942,MD,,M,"Stroke; A spontaneous report was received from a Consumer and Other HCP concerning a 84Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event like Stroke. The patient's medical history provided no adverse event. Relevant concomitant medications were reported like atorvastatin calcium, ezetimibe, niacin, metoprolol, acetylsalicylic acid, levothyroxine sodium, and iron supplement. On 4th Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 038k20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On date 5th Feb 2021, The patient experienced the event like Stroke, which required hospitalization. It was noted the patient's speech was getting better, but the left side of his body was still paralyzed. There was no treatment information provided There were no laboratory details provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event is unknown.; Reporter's Comments: Although a temporal association exit, provided information is not adequate to assess the causal association between the event and mRNA-1273. Critical details such as the medical history and diagnostic report is lacking. Causality is also confounded by the patient's advanced age and suspected cardiac related condition (patient is on antihypertensive noted in conmed)",Not Reported,,Not Reported,Yes,,Not Reported,U,02/04/2021,02/05/2021,1.0,UNK,STATIN EZ; NIACIN; METOPROLOL; ASPIRIN (E.C.); SYNTHROID; IRON SUPPLEMENT,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Cerebrovascular accident'],1,MODERNA,OT 1067943,NC,,M,"Blood pressure dropped to 94/34; Covid related pneumonia; Covid-19; A spontaneous report was received from a consumer concerning 90 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, blood pressure dropped to 94/34 (hypotension), COVID-19 (Covid-19), and COVID related pneumonia (COVID-19 pneumonia). The patient's medical history was not provided. No relevant concomitant medications were reported. On 23-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 04-Feb-2021, the patient experienced the events, blood pressure dropped to 94/34 (hypotension), body temperature was 101.0 0F (Fever), COVID-19 (Covid-19), and COVID related pneumonia (COVID-19 pneumonia).The patient was hospitalized on the same day (04-Feb-2021) and discharged on 12-Feb-2021 post treatment. Blood pressure dropped to 94/34 mmHg and body temperature was 101.0 0F during hospital admission on 04-Feb-2021. Treatment for the event included remdesivir, ceftriaxone, azithromycin, and oxygen therapy. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events, blood pressure dropped to 94/34, COVID-19, and COVID related pneumonia, were considered resolved on 12-Feb-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,9.0,Not Reported,Y,01/23/2021,02/04/2021,12.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Blood pressure measurement', 'Body temperature', 'COVID-19', 'COVID-19 pneumonia', 'Hypotension']",1,MODERNA,OT 1067944,OR,20.0,F,"Swollen and painful lymph nodes in the left arm where the shot was received.; Swollen and painful lymph nodes in the left arm where the shot was received.; This is a spontaneous report from a contactable healthcare professional (patient). A 20-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the left arm on 07Jan2021 12:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced swollen and painful lymph nodes in the left arm where the shot was received on 09Jan2021 13:00. Happened after the first dose and the second dose and have not left. The patient did not received any treatment for the events. The patient underwent lab tests and procedures which included COVID-19 test Nasal Swab: unknown results on 30Jan2021. The outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/09/2021,2.0,PVT,,,,,,"['Lymph node pain', 'Lymphadenopathy', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1067945,,35.0,F,"Hives all over my body; Severe abdominal pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot/batch number and expiry date unknown), intramuscular on 06Jan2021 13:00 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient experienced hives all over her body and severe abdominal pain on 07Jan2021. The patient received treatment for the events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. The outcome of the events were recovered on an unspecified date. The events were reported as non-serious. No seriousness criteria provided. The facility where the most recent COVID-19 vaccine was administered was in the hospital. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Abdominal pain', 'Urticaria']",UNK,PFIZER\BIONTECH,OT 1067946,CA,44.0,M,"injection site soreness; This is a spontaneous report from a contactable consumer (Patient). A 44-year-old (also age at vaccination) male patient receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration at the left arm on 09Jan2021 (reported as 29Jan2021; pending clarification) 08:30 at SINGLE DOSE for covid-19 immunization. Medical history included that prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. The patient was vaccinated at a workplace clinic. The patient's concomitant medications were not reported. It was reported that the patient experienced injection site soreness on 30Jan2021 (as reported date: pending clarification). The outcome of the event was recovering. The treatment received is Diclofenac 100mg. Case was not considered serious (for any criteria).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/09/2021,01/30/2021,21.0,WRK,,,Medical History/Concurrent Conditions: COVID-19 (diagnosed with COVID-19),,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1067947,MO,28.0,F,"Significant swelling in left axillary lymph node; fever up to 102.7 F/low grade temp in low-mid 100s; Severe chills; fatigue; Moderate muscle aches; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date unknown) in the hospital, via an unspecified route of administration on 28Jan2021 at 15:00 on the left arm at a single dose for COVID-19 immunization. Medical history included allergies to penicillin and sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol, norgestimate (ESTARYLLA) for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 (lot number: EL1284, expiry date unknown) on 06Jan2021 at 12:00 PM on the left arm for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient experienced fever up to 102.7 F lasting from 05:00 on 29Jan2021 to 01:00 on 30Jan2021. The patient took 3 doses of 1000 mg Tylenol during this time period which would bring temp down to high 100s for an hour or two. After 01:00 on 30Jan2021, the patient had low grade temp in low-mid 100s until the afternoon. The patient also experienced severe chills, fatigue, moderate muscle aches on 29Jan2021 at 05:00. The patient had significant swelling in left axillary lymph node starting on the evening of 30Jan2021. The patient received treatment for the event fever but did not receive treatment for the other events. The outcome of the events was recovering. The events were reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,PVT,ESTARYLLA,,Medical History/Concurrent Conditions: Penicillin allergy; Sulfonamide allergy,,,"['Body temperature', 'Chills', 'Fatigue', 'Lymphadenopathy', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH, 1067948,CA,80.0,M,"Moderate allergic reaction; itchy skin; itchy eyes; Headache; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 9263), via an unspecified route of administration in right arm on 24Jan2021 11:45 at a single dose for COVID-19 immunization. Medical history included Diabetes2, HiBloodPress and HiCholesterol. Concomitant medication included lisinopril, simvastatin, and unspecified diabetes medication. On 26Jan2021, the patient experienced moderate allergic reaction, itchy skin, itchy eyes and headache. The patient was taking antihistamines with some relief for moderate allergic reaction, itchy skin, itchy eyes. There was no treatment for headache. The outcome of the events was recovering. Prior and since the vaccination, the patient was not tested for COVID-19. The events were assessed as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/26/2021,2.0,PUB,LISINOPRIL; SIMVASTATIN,,Medical History/Concurrent Conditions: Blood pressure high; Cholesterol high; Type 2 diabetes mellitus,,,"['Eye pruritus', 'Headache', 'Hypersensitivity', 'Pruritus']",1,PFIZER\BIONTECH, 1067949,MI,56.0,F,"Injection site pain; Fever of 101.3; Tired; Headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiry date: unknown), via an unspecified route of administration on 18Jan2021 20:00 (at the age of 56 years old), at a single dose in the left arm for covid-19 immunisation. Medical history included allergies: dust, mold, trees & grass; and diagnosed with covid-19 on unspecified date. Concomitant medications included escitalopram oxalate (LEXAPRO) and fexofenadine hydrochloride (ALLEGRA 24 HOUR). The patient previously took augmentin and experienced allergies. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient has not been tested for covid-19 since the vaccination. On 19Jan2021 20:00, the patient experienced injection site pain for seven days and fever of 101.3 which lasted for 12 hours; tired and had a headache for two days. The patient did not receive any treatment for all the events. Outcome of all the events was recovered on unspecified date. The events were reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/19/2021,1.0,UNK,LEXAPRO; ALLEGRA 24 HOUR,,Medical History/Concurrent Conditions: Allergy to molds; Allergy to plants; COVID-19; Dust allergy,,,"['Body temperature', 'Fatigue', 'Headache', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1067950,SC,70.0,F,"she experienced dizziness and weakness; she experienced dizziness and weakness; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EL9262, expiry: May2021), via an unspecified route of administration (at the age of 70years) on 27Jan2021 at single dose for covid-19 immunisation. Medical history included hypertension and Crohn's. Concomitant medications included lisinopril, estradiol, levothyroxine and adalimumab (HUMIRA) for Crohn's. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on Wednesday. Next morning (on 28Jan2021) from Thursday until Saturday, she experienced dizziness and weakness as stated, ""when I woke I was severely dizzy and just weak and that is continued yesterday, well let's say Thursday, Friday and yesterday. I am feeling better today but I wanted to report that"". The patient wanted to know if she should receive the second dose of the vaccine because these two symptoms were reported as signs of a severe allergic reaction and that's a contraindication to receive the second dose of the vaccine. The patient had some blood work done on an unspecified date. The patient took some diphenhydramine hydrochloride (BENADRYL) according to her physician. The patient further stated, ""I am just, I guess concerned, it does say on the paperwork that I received that you should not take the second dose if you had a severe allergic reaction which it list the dizziness and weakness one of those included so I am assuming that I should not take the second dose."" The patient considered the events as non-serious. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/28/2021,1.0,UNK,LISINOPRIL; ESTRADIOL; LEVOTHYROXINE; HUMIRA,,Medical History/Concurrent Conditions: Crohn's; Hypertension,,,"['Asthenia', 'Blood test', 'Dizziness']",1,PFIZER\BIONTECH, 1067951,CA,42.0,M,"Coughing; loss of taste and smell; loss of taste and smell; This is a spontaneous report from a contactable consumer (reporting for himself). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL3302, expiration date unknown) via an unspecified route of administration in the left arm on 25Jan2021 (at 42 years old) at a SINGLE DOSE for COVID-19 immunization. The patient received the vaccine at a Hospital, reported as ""Military Base."" The patient had no medical history and had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior to vaccination, did not receive any other vaccines within 4 weeks prior to BNT162B2, and has not been tested for COVID since the vaccination. On 26Jan2021, the patient experienced coughing, loss of taste and smell. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient treatment for the adverse events. Outcome of the events was not recovered. The events were reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,MIL,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Ageusia', 'Anosmia', 'Cough']",1,PFIZER\BIONTECH, 1067952,IL,41.0,F,"flu-like symptoms; headache; aches; chills; night sweats; more fatigue than normal; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration in the left arm on 17Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included Seizure disorder, depression, anxiety, mild hyperthyroidism and Penicillin allergy. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included carbamazepine, citalopram, buspirone hydrochloride (BUSPAR), and omeprazole. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced flu-like symptoms, headache, aches, chills, night sweats, and more fatigue than normal on 17Dec2020 19:00. Treatment was not provided in response to the events. The outcome of the events was recovered on an unspecified date. The reporter assessed the events as non-serious. The patient has not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/17/2020,12/17/2020,0.0,PVT,CARBAMAZEPINE; CITALOPRAM; BUSPAR; OMEPRAZOLE,,Medical History/Concurrent Conditions: Anxiety; Depression; Hyperthyroidism; Penicillin allergy; Seizure,,,"['Chills', 'Fatigue', 'Headache', 'Influenza like illness', 'Night sweats', 'Pain']",1,PFIZER\BIONTECH, 1067953,NC,73.0,F,"I am an asthmatic. Fine until 25 mins. after vaccine then tightness in chest that lasted about 45-60 mins. Next day asthma had started.; I am an asthmatic. Fine until 25 mins. after vaccine then tightness in chest that lasted about 45-60 mins. Next day asthma had started.; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: LL3248, expiry date not reported), via an unspecified route of administration at the right arm on 25Jan2021 09:00 at single dose for COVID-19 immunization. Medical history included allergies, chronic asthma, immune deficiency, high blood pressure, allergic to injections and infusions. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. On 25Jan2021 09:00, the patient stated that she was an asthmatic. She was fine until 25 mins. After vaccine, she then experienced tightness in chest that lasted about 45-60 mins. On the next day, asthma had started. She had the vaccine on Monday, and called her physician and requested to come to be checked which she did. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unspecified date. Therapeutic measure was taken for the events that included Symbicort inhaler. Clinical outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Allergy; Asthma; Blood pressure high; Drug allergy; Immune system disorder; Infusion reaction,,,"['Asthma', 'Blood pressure measurement', 'Chest discomfort']",1,PFIZER\BIONTECH, 1067954,NV,27.0,F,"Fever; Headache; Lightheaded; This is a spontaneous report from a contactable consumer. A 27-year-old female patient received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 09:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced Fever, Headache, Lightheaded; all on 31Jan2021 at 05:00 AM. No treatment was received for the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,01/31/2021,1.0,UNK,,,,,,"['Dizziness', 'Headache', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1067955,WI,36.0,F,"Swelling of the lymph nodes (mid neck/clavicle area) in the same arm as the injection.; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported) (at 36 years of age), via an unspecified route of administration in the left arm on 23Jan2021 10:15 at a single dose for COVID-19 immunization. Medical history included multiple sclerosis (MS) and allergy to nickel. Concomitant medication included interferon beta-1a (AVONEX), buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE), colecalciferol (VITAMIN D [COLECALCIFEROL]), and bupropion hydrochloride (WELLBUTRIN). The patient previously took REGLAN [metoclopramide] and experienced allergy. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE first dose (at 36 years of age) on 02JAN2021 08:30 AM via unknown route of administration in the left arm for COVID-19 immunization. The patient was not pregnant. She had not had other vaccine in four weeks prior to covid vaccine. She had no covid prior vaccination and she was not tested for covid post vaccination. The patient experienced swelling of the lymph nodes (mid neck/clavicle area) in the same arm as the injection on 25Jan2021 with outcome of recovering. There was no treatment received for the events. The event resulted to Doctor or other healthcare professional office/clinic visit. Information on the lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/25/2021,2.0,PVT,AVONEX; SUBOXONE; VITAMIN D [COLECALCIFEROL]; WELLBUTRIN,,Medical History/Concurrent Conditions: Multiple sclerosis; Nickel sensitivity,,,['Lymphadenopathy'],2,PFIZER\BIONTECH, 1067956,PA,48.0,F,"left side of neck was very sore; felt a swollen lump /lymph about halfway between my ear and bottom of my neck; This is a spontaneous report from a contactable consumer (Patient). A 48-year-old female patient (also the age at vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown: Unable to locate or read the details), via an unspecified route of administration at the left arm on 23Jan2021 12:45 PM at SINGLE DOSE for Covid-19 immunization. Medical history included Chiari Malformation (reported as other medical history). The patient has no COVID prior to vaccination, also not COVID tested post vaccination. The patient had no known allergies. The patient is not pregnant. There was no other vaccine in four weeks. It was reported that the patient had other medications in two weeks (unspecified). The patient had the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Jan2021 at 12:45 PM at the left arm for COVID-19 immunization (Lot number not reported: Unable to locate or read the details, facility type vaccine: Other). It was reported by the patient that: ""I woke up this morning (on 31Jan2021 at 08:00 AM) and my left side of neck was very sore. I went to rub it and immediately felt a swollen lump /lymph about halfway between my ear and bottom of my neck. It is about the size of a dime. My second dose was 8 days ago (23Jan2021). I am assuming this is normal response to Pfizer vaccine, but all I read said reactions should be over 2 to 4 days after vaccine. Is this considered normal or should I contact my PCP? "" No treatment was received. The outcome of the events was not recovered. Information about Lot and batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/31/2021,8.0,UNK,,,Medical History/Concurrent Conditions: Chiari malformation,,,"['Neck pain', 'Skin mass']",2,PFIZER\BIONTECH, 1067957,TN,,M,"sore arm; This is a spontaneous report from a contactable consumer. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization and ibuprofen (MOTRIN), via an unspecified route of administration from an unspecified date at 600 mg for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient took ibuprofen 600mg 1hr before getting 1st dose of vaccine on Wednesday. He only had a sore arm after the 1st dose. The patient read that he should not have taken medication before vaccine. He was asking for information about the vaccine efficacy since he took ibuprofen before the dose. He mentioned that maybe he should stop taking his antihistamine before the next dose. He was most concerned that he messed up the vaccine. The action taken in response to the event for ibuprofen and the outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1067958,WI,51.0,F,"I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; left arm soreness onset evening of vaccine for about 1.5 days; This is a spontaneous report from a contactable nurse (also the patient). A 51-year-old female (also the age at vaccination) patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248), via an unspecified route of administration at the left arm on 07Jan2021 14:40 (also reported as 02:45 PM) at SINGLE DOSE for Covid-19 immunization. The patient was vaccinated at a Hospital. The patient is not pregnant at the time of the report. Medical history included Environmental allergies: some trees and grass (also reported as Known allergies: No). The patient had no COVID prior to vaccination. Th patient was not COVID tested post vaccination. No other vaccine in four weeks. Concomitant medication included (reported as Other medications in two weeks) bupropion hydrochloride (WELLBUTRIN), loratadine, pseudoephedrine sulfate (CLARITIN-D), montelukast sodium (SINGULAIR), diphenhydramine hydrochloride (BENADRYL), vitamin d nos (VITAMIN D NOS) and MVM (exact meaning unspecified). It was reported that: ""Administration time on my paperwork was documented incorrectly; I received 07Jan2021 dose at 2:40pm and not the 1:40pm time that is documented. I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration (reported as 5:30 PM), lasting about 2 hours and resolved; left arm soreness onset evening of vaccine for about 1.5 days."" The patient was not treated for the events. The outcome of the events was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,PVT,WELLBUTRIN; CLARITIN-D; SINGULAIR; BENADRYL; VITAMIN D NOS,,Medical History/Concurrent Conditions: Allergy to plants (Other medical history: Environmental allergies: some trees and grass),,,"['Abdominal pain', 'Chills', 'Diarrhoea', 'Pain in extremity']",1,PFIZER\BIONTECH, 1067959,NJ,41.0,F,"face started to feel ""hot and on fire""; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Asthma,,,"['Dysgeusia', 'Dyspnoea', 'Erythema', 'Eye pruritus', 'Fatigue', 'Feeling hot', 'Headache', 'Heart rate', 'Heart rate increased', 'Musculoskeletal stiffness', 'Nausea', 'Pain in extremity', 'Vaccination site warmth']",1,PFIZER\BIONTECH,OT 1067960,LA,,M,"has been on immunotherapy for lung cancer; has been on immunotherapy for lung cancer; off-balance weakness/off-balance; off-balance weakness; feeling tired/fatigue; sleeping a lot; This is a spontaneous report from a contactable consumer (patient's wife). A male patient (husband) of an unspecified age (Age: 78, Units: Unknown) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included the patient had been on immunotherapy for lung cancer for almost a year and it had been working and shrinking everything; took the chemo prior but stopped because of his feet as it gave him neuropathy so he only took 3; and neuropathy (he was fantastic prior to the shot with the only symptom being his feet neuropathy). Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunization (took the first dose of Pfizer COVID-19 vaccine and he was fine). The reported stated after the patient's second dose (unspecified date), he was feeling tired and sleeping a lot since this past Saturday (30Jan2021). Upon recent follow-up, the reporter asked if how long side effects last and if anyone had a reoccurrence of symptoms. The reporter was calling regarding her husband who had the second dose of vaccine and the patient had symptoms: fatigue and tiredness and it went away in a day and a half, but then he had a reoccurrence, after 2-3 days. On 04Feb2021, the patient had off-balance weakness. Yesterday morning (04Feb2021), he got up and was really off-balance. The nurse said it should subside in 1-2 days, and it did but then he had a reoccurrence. She stated he had been on immunotherapy for lung cancer for almost a year and it had been working and shrinking everything. The patient received the vaccine at (name) in (state name). The caller asked if there was an interaction with the immunotherapy and the vaccine. And also, asked if the patient should have not gotten the vaccine. She stated she will call the doctor after the call. The caller stated at the nursing home, not one person had a reaction with the second shot. The outcome of the events feeling tired/fatigue, sleeping a lot, and ""off balance weakness"" was not recovered. Information about Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,01/30/2021,,UNK,,,Medical History/Concurrent Conditions: Chemotherapy (it gave him neuropathy so he only took 3); Lung cancer (for almost a year and it had been working and shrinking everything); Neuropathy (He was fantastic prior to the shot with the only symptom being his feet neuropathy.),,,"['Asthenia', 'Balance disorder', 'Fatigue', 'Hypersomnia', 'Off label use', 'Product use issue']",2,PFIZER\BIONTECH, 1067961,OH,83.0,F,"diarrhea; injection site pain; tiredness; headache; muscle pain; chills with elevated temp; chills with elevated temp; joint pain; injection site swelling and redness; injection site swelling and redness; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration at the left arm on 28Jan2021 at 08:00 AM (at age of 83 years old) at a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The facility where the most recent COVID-19 vaccine was administered was reported as ""Other"". The patient's medical history included stage 3 kidney, prediabetes, and allergies to sulfa. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received unspecified concomitant medications (patient received other medications within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took hypromellose (GENTEAL; reported as ""gen-teal"") and experienced allergy. On 29Jan2021 at 02:00 AM, the patient experienced diarrhea, injection site pain, tiredness, headache, muscle pain, chills with elevated temp, joint pain, injection site swelling and redness, nausea, and feeling unwell. The patient did not receive treatment for the events. The patient has not been tested for COVID-19 since the vaccination. The events were reported as non-serious. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Prediabetes (stage 3 kidney prediabetes); Stage 3 acute kidney injury (stage 3 kidney prediabetes); Sulfonamide allergy (Allergies:sulfa),,,"['Arthralgia', 'Body temperature', 'Body temperature increased', 'Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Nausea', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 1067962,NV,64.0,M,"Sore throat; chills; headache; lower back pain; muscle pain; sinus drainage; severe cough; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL9262), via an unspecified route of administration on the right arm on 27Jan2021 09:30 at a single dose for COVID-19 immunisation. Medical history included hypertension. The patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan, atenolol, and atorvastatin. The patient experienced sore throat, chills, headache, lower back pain, muscle pain, severe cough with thick yellow phlegm on 29Jan2021 13:00. It was reported that the patient had sinus drainage on 29Jan2021 13:00. There was no treatment for the events. The patient has not recovered from the events yet.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/29/2021,2.0,UNK,LOSARTAN; ATENOLOL; ATORVASTATIN,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Back pain', 'Chills', 'Cough', 'Headache', 'Myalgia', 'Oropharyngeal pain', 'Paranasal sinus hypersecretion']",1,PFIZER\BIONTECH, 1067963,PA,42.0,F,"Lip tingling/fizzing; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3246), via an unspecified route of administration (at the age of 42-years-old) on 21Jan2021 10:00 at a single dose in right arm for COVID-19 immunization. Medical history included none. No allergies to medications, food, or other products. Concomitant medication included rosuvastatin calcium (CRESTOR), spironolactone, tacrolimus, and macrogol 3350 (MIRALAX). The patient experienced lip tingling/fizzing on 28Jan2021 19:00 with outcome of recovering. No treatment received for the adverse event. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The event was considered as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/28/2021,7.0,PVT,CRESTOR; SPIRONOLACTONE; TACROLIMUS; MIRALAX,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Paraesthesia oral'],1,PFIZER\BIONTECH, 1067964,MD,,F,"injection site/arm soreness/just the area around the needle site/Just tender; This is a spontaneous report received from a Pfizer-sponsored program, Pfizer First Connect. A contactable consumer (reported for herself) reported that a female patient of an unspecified age (age: 82; unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient mentioned ""injection site/arm soreness"". The patient said it was just the area around the needle site. Just tender. It was not extremely sire, it was tender sore. The patient was asking if how she would know if they will get a hematoma after the vaccine and if she should expect anything and the patient was made aware of signs of potential hematoma with redness, swelling, pain or bruising. The patient was referred to speak with healthcare professional (HCP) if she believes there is a hematoma or concerns about potential hematoma forming. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,01/01/2021,,UNK,,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1067965,CA,78.0,M,"the onset of blurred vision in one eye and flashing colored lights in both eyes.; the onset of blurred vision in one eye and flashing colored lights in both eyes.; This is a spontaneous report from a contactable physician (patient). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), intramuscular at the left arm on 21Jan2021 08:45 at single dose for COVID-19 immunization. Medical history included Parkinson's and neuropathy. The patient has allergies to CIPRO antibiotics. Concomitant medication included unspecified multiple supplements. On 22Jan2021 at 09:00 (24 hours after vaccination), the patient had the onset of blurred vision in one eye and flashing colored lights in both eyes. This was unlike anything he has ever experienced, and it persisted for several hours. Vision gradually returned to normal and lights disappeared. This was not a retinal detachment or vitreous detachment. It was not associated with eye pain. The patient did not receive any treatment for the events. The patient recovered from the events on an unspecified date in 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/22/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Neuropathy; Parkinson's disease (Parkinson's),,,"['Photopsia', 'Vision blurred']",UNK,PFIZER\BIONTECH,OT 1067966,WI,51.0,F,"just a sore arm starting approx 6 hours after injection; This is a spontaneous report from a contactable healthcare professional (patient). A 51-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3249; expiration date: unknown) at vaccination age of 51-year-old intramuscular in the right arm on 15Jan2021 10:00 at a single dose for covid-19 immunization. Medical history included high blood pressure, and allergies to penicillin and sulfa. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included unspecified medication. The patient received her most recent COVID-19 in a public health clinic/veterans administration facility. The patient reported that she did no adverse events, she was just a sore arm starting approximately 6 hours after injection (15Jan2021) and lasting about 24 hours (16Jan2021). The event was non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovered on 16Jan2021. No follow up attempts are possible. Information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,PUB,,,Medical History/Concurrent Conditions: Blood pressure high; Penicillin allergy; Sulfonamide allergy,,,['Pain in extremity'],1,PFIZER\BIONTECH,OT 1067967,FL,67.0,M,"Face flush for 6 hours; This is a spontaneous report from a non-contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration at the age of 67 years on 25Jan2021 11:30 at single dose in the left arm for COVID-19 immunization. Medical history included mild hypertension. The patient had no allergies to medications, food, or other products. Prior vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included rosuvastatin, losartan and hctz. The patient experienced face flush (non-serious) for 6 hours on 25Jan2021 11:45. There was no treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since vaccination. The outcome of the event was recovered. No follow-up attempts are possible, information about batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,UNK,ROSUVASTATIN; LOSARTAN; HCTZ,,Medical History/Concurrent Conditions: Hypertension,,,['Flushing'],1,PFIZER\BIONTECH, 1067968,HI,30.0,M,"Headache; Pain at injection site; Swollen injection site; Fatigued; This is a spontaneous report from a contactable consumer (patient). A 30 -year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9626), via an unspecified route of administration (on the left arm) on 30Jan2021 16:15 (at the age of 30-years-old), single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included amlodipine;olmesartan, lorazepam. The patient experienced Headache,Pain at injection site, Swollen injection site, Fatigued, all on 31Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021 Nasal Swab (reported as post vaccination). No treatment received for the adverse events. The outcome of the events was not recovered. Prior to vaccination, it is unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (date of test reported as 06Jan2021). The reporter assessed the events as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/31/2021,1.0,PVT,AMLODIPINE;OLMESARTAN; LORAZEPAM,,,,,"['Fatigue', 'Headache', 'SARS-CoV-2 test', 'Vaccination site pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 1067969,NJ,47.0,F,"Fever; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL 9262, expiration date was unknown), via an unspecified route of administration on 26Jan2021 at 08:30 AM at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as the hospital. The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Jan2021 at 11:00 AM, the patient experienced fever. The patient assessed the event as non-serious. The patient did not receive any treatment for the adverse event. The patient was not recovered from the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/31/2021,5.0,PVT,,,,,,['Pyrexia'],1,PFIZER\BIONTECH, 1067970,CA,62.0,M,"sciatic nerve diagnosed as inflamed only left leg and shot provided left arm; This is a spontaneous report from a contactable nurse (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration in right arm on 08Jan2021 14:00 at a single dose for Covid-19 immunization. Medical history included blood pressure. Concomitant medication included unspecified blood pressure medication. On 09Jan2021 at 2pm, sciatic nerve was diagnosed as inflamed only on left leg and shot (treatment) was provided in left arm. Patient visited emergency room/department, methylprednisolone sodium succinate (PF) was given as treatment. The event was reported as non-serious, patient was not hospitalized. The patient underwent lab tests which included COVID-19 Nasal RT-PCR: negative on 25Jan2021 (Nasal Swab). Outcome of the event was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure abnormal,,,"['SARS-CoV-2 test', 'Sciatica']",1,PFIZER\BIONTECH, 1067971,NC,,U,Right arm remains red; Sweats profusely; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2; Lot number and expiry date not reported) via an unspecified route of administration to right arm from 15Jan2021 at 09:00 at single dose for covid-19 immunization. Medical history included arthritis from an unknown date. There were no concomitant medications. The patient experienced Right arm remains red and sweats profusely on 17Jan2021 at 12:00 AM. The events were reported as non-serious. No treatments were received for the reported events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/17/2021,2.0,PUB,,,Medical History/Concurrent Conditions: Arthritis,,,"['Hyperhidrosis', 'Vaccination site erythema']",1,PFIZER\BIONTECH, 1067972,NY,78.0,F,"the vision in my right eye became blurry; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el9262), via an unspecified route of administration in the left arm on 26Jan2021 09:00 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no known allergies. Concomitant medication included metoprolol succinate (TOPROL 25 mg) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el3246), via an unspecified route of administration in the left arm on 05Jan2021 11:30 for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. She was not pregnant. The patient experienced ""the vision in my right eye became blurry"" on 26Jan2021 09:15. The patient reported that the event was ""still is"" as date of the report. The event was reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. The patient had not been tested for COVID-19 since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,SEN,TOPROL,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['Vision blurred'],2,PFIZER\BIONTECH, 1067973,MD,30.0,F,"sudden rash appear on left side of my chest and shoulder, just visually a bunch of red dots; Swollen lymph nodes, both collar bone and neck; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at the left arm on 26Jan2021 at single dose for COVID-19 immunisation. The patient has no medical history. The patient was not pregnant at the time of vaccination. Concomitant medication included ethinylestradiol, levonorgestrel (LUTERA). The patient experienced swollen lymph nodes, both collar bone and neck noticed the evening of 30Jan2021. Expected as much for an immune response, but then she had a sudden rash appear on left side of her chest and shoulder, just visually a bunch of red dots, no itching or discomfort the afternoon of 31Jan2021. She was reporting immediately, so no recovery yet. The patient did not receive any treatment for the events. The patient has not recovered from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/30/2021,4.0,WRK,LUTERA,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Lymphadenopathy', 'Rash macular']",UNK,PFIZER\BIONTECH, 1067974,NJ,65.0,F,"experience left arm pain radiating from my shoulder down to my fingers; experience left arm pain radiating from my shoulder down to my fingers; left arm weakness; This is a spontaneous report from a contactable physician (patient). A 65-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJUe85; expiration date: unknown) at vaccination age of 65-year-old intramuscularly in the left arm on 20Jan2021 10:30 at a single dose for covid-19 immunization. The patient's medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJUe85) at vaccination age of 65-year-old intramuscularly in the left arm on 30Dec2020 at a single dose for covid-19 immunization. The patient received the most recent COVID-19 vaccine in a hospital. On 21Jan2021 after the second Pfizer dose (24 hours after the injection), she began to experience left arm pain radiating from her shoulder down to her fingers. The pain was sharp, constant and associated with left arm weakness. This has persisted for 10 days with no relief and she was still experiencing this pain now. The events were considered as non-serious and did not require treatment. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/21/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Muscular weakness', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH,OT 1067975,NC,45.0,F,"dizziness; achiness behind my eyes for 16 days; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration at the left arm on 14Jan2021 at 12:30 PM at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included penicillin allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (lot number: EK5730) on 26Dec2020 at 03:30 PM (at the age of 45 years old) at the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 16Jan2021 at 09:00 AM, the patient experienced dizziness and achiness behind her eyes for 16 days. The patient did not receive treatment for the events. The events were reported as non-serious. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19 which included Nasal Swab: Negative on 31Jan2021. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/16/2021,2.0,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Dizziness', 'Eye pain', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1067976,MI,65.0,M,"Nausea/feel like vomiting-riding bike in esophagus; indigestion; diarrhea; Slight headache on injection day; This is a spontaneous report from a contactable consumer reporting for himself. A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 30Jan2021 08:30 AM at single dose for COVID-19 immunization in a hospital. Medical history included hypertension, anxiety and penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications received within two weeks of vaccination. The patient experienced slight headache on injection day. The patient experienced nausea and indigestion leading to diarrhea and feel like vomiting - riding bike in esophagus on 31Jan2021 at 01:00 AM. The patient did not receive any treatment for the events. The reporter assessed the events as non-serious. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Anxiety; Hypertension; Penicillin allergy,,,"['Diarrhoea', 'Dyspepsia', 'Headache', 'Nausea']",1,PFIZER\BIONTECH, 1067977,,,F,"pain; inflammation,; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer, reporting for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain and inflammation. She was concerned about taking Advil and/or Tylenol after her surgery on Monday. She has not taken those medications yet, however, she asked if taking them for any pain or inflammation, could that interfere with the immunization process of her vaccination. The outcome of the events was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,,,UNK,,,,,,"['Inflammation', 'Pain']",1,PFIZER\BIONTECH, 1067978,TX,,F,"Vomiting; vertigo; headache; This is a spontaneous report from a contactable patient (consumer). female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on the left arm, at age 37 years, first dose on an unspecified date, at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced vomiting, vertigo and headache on 31Jan2021 10:00. Facility where the most recent COVID-19 vaccine was administered was at a Administration facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment was not received for the adverse event. Since the vaccination, the patient has nor been tested for COVID-19. The outcome of the event was not recovered. Case was reported as non-serious. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,01/31/2021,,PUB,,,,,,"['Headache', 'Vertigo', 'Vomiting']",1,PFIZER\BIONTECH, 1067979,,,F,"chills; congestion; achiness; runny nose; pain around the sinuses; fever; cough; tired; low appetite; sneezing; headache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 18Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed symptoms 11 days after her first dose. On 29Jan2021, she reported Chills, Congestion, Achiness, Runny nose, Pain around the Sinuses, Fever, Cough, Tired, Low appetite, Sneezing and Headache. The patient wanted to know if these side effects were reported with Pfizer Covid-19 vaccine. The patient also asked if she can I still develop COVID-19 infection after receiving the first dose. Also, if the vaccine cause a false positive COVID-19 test. She also asked what was the timing of the 2nd dose of vaccine and if she can get the second dose 21 days after dose 1. The patient also asked if both doses of Pfizer COVID-19 vaccine are identical. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,01/29/2021,11.0,UNK,,,,,,"['Chills', 'Cough', 'Decreased appetite', 'Fatigue', 'Headache', 'Nasal congestion', 'Pain', 'Pyrexia', 'Rhinorrhoea', 'Sinus pain', 'Sneezing']",1,PFIZER\BIONTECH, 1067980,VA,90.0,F,"diarrhea/ Stools loose; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), via an unspecified route of administration into the left arm on 30Jan2021 13:00 at a single dose for COVID-19 immunisation. Medical history included metastatic thyroid cancer and ventilator/oxygen/feeding tube dependent. Patient was not pregnant. Concomitant medication included metoprolol (METOPROLOL), furosemide (LASIX), valacyclovir (VALACYCLOVIR), bifidobacterium lactis (PROBIOTIC) and cetirizine hydrochloride (CETIRIZ). On 30Jan2021 13:30, patient experienced diarrhea; also reported as stools loose. The event was reported as non-serious and the patient was treated with loperamide. Outcome of event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,PUB,METOPROLOL; LASIX [FUROSEMIDE]; VALACYCLOVIR [VALACICLOVIR]; PROBIOTIC; CETIRIZ,,Medical History/Concurrent Conditions: Dependence on oxygen therapy; Dependence on respirator; Feeding tube user; Thyroid cancer metastatic,,,['Diarrhoea'],UNK,PFIZER\BIONTECH, 1067981,TX,64.0,F,"very active stomach, diarrhea due to problem (nervous)/bowel movement really often; very active stomach, diarrhea due to problem (nervous)/bowel movement really often; Stool being dark is concerning; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EL8982), intramuscular in right arm on 29Jan2021 at SINGLE DOSE for Covid-19 immunisation. Medical history included high blood pressure and had insulin resistance. She had her first dose of BNT162B2 on 03Jan2021. Concomitant medication included metformin. She also mentioned 'Candistan Clotrimazole' (not clear nor clarified) something like that, and also took 'Premarin' (not clear nor clarified) it's hormone for menopause. She got the vaccine instead of 21 days it was 26 days. Since when she had the vaccine, her stomach was really active, diarrhea due to problem (nervous). She informed having bowel movements like really often. Today (Jan2021), she already went twice but the thing was she was going and it was like too dark, mentioned that stool being dark was concerning. She took Libertrim S11 Trimebutine Simethicone, for diarrhea. The outcome of events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/01/2021,,UNK,METFORMIN,,Medical History/Concurrent Conditions: Blood pressure high; Insulin resistance,,,"['Diarrhoea', 'Faeces discoloured', 'Nervousness']",2,PFIZER\BIONTECH,OT 1067982,WA,79.0,M,"slight fatigue the next day; some left arm soreness; This is a spontaneous report from a contactable consumer (reported for himself). A 79-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL 9261, expiry date not reported), via an unspecified route of administration on 21Jan2021 at a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure, a-fib, small stroke 5 years ago and some weakness from that (stroke). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included atenolol, amlodipine, warfarin, and lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. On 26Jan2021, patient experienced slight fatigue the next day (as reported) and some left arm soreness. No treatments received in response to the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events fatigue and left arm soreness was recovered in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/26/2021,5.0,PVT,ATENOLOL; AMLODIPINE; WARFARIN; LISINOPRIL,,Medical History/Concurrent Conditions: AFib; Blood pressure high; Stroke (small stroke 5 years ago); Weakness (some weakness from that),,,"['Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH, 1067983,MN,51.0,F,"Fever over 100; headache; chills; joint soreness; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264, expiration date was not reported), via an unspecified route of administration on the left arm on 30Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included Sulfa allergy, penicillin allergy, COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included estradiol. The patient experienced fever over 100, headache, chills, joint soreness and arm soreness on 31Jan2021 at 04:00 am. No treatment was given in response to the events. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,01/31/2021,1.0,PUB,ESTRADIOL,,"Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19.); Penicillin allergy; Sulfonamide allergy",,,"['Arthralgia', 'Body temperature', 'Chills', 'Headache', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH, 1067984,VA,50.0,F,"headache on right side of head; back went out from right side and cannot bend over; right leg hurts; right foot tingles; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246) via an unspecified route of administration on the right arm on 29Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included patient diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization (lot number: EK4176, administration time: 02:00 PM on left arm). The patient previously took levofloxacin (LEVAQUIN) and cefalexin (KEFLEX) and experienced allergies to medications. On 30Jan2021 10:00 PM, the patient experienced headache on right side of head, back went out from right side and cannot bend over, right leg hurts and right foot tingles. No fever. No treatment was received for the adverse events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a hospital. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,PVT,,,Medical History/Concurrent Conditions: COVID-19 (if covid prior vaccination: Yes),,,"['Headache', 'Joint range of motion decreased', 'Pain in extremity', 'Paraesthesia']",2,PFIZER\BIONTECH, 1067985,FL,77.0,M,"joint pain in his big toe on his left foot; This is a spontaneous report from a contactable consumer (patient himself). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9262, NDC/UPC number and expiry date were unknown), via an unspecified route of administration in the left deltoid (also reported as the left shoulder) on 29Jan2021 at 09:30 AM at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as the public health clinic/veterans administration facility. Relevant medical history included sleep problem. The patient had no allergies to medications, food, or other products. Concomitant medication included promethazine (strength: 25 mg) for sleep problem. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had the Pfizer COVID vaccine shot on Friday morning, on 29Jan2021, and later that day by the evening, he started to experience some joint pain in his big toe on his left foot and the pain had not changed or gone away since then. The patient assessed the event as non-serious. The adverse event did not require any visit to the physician office or emergency room. The patient further stated that he haven't done anything. It happened on Friday and it was there the day prior reporting (yesterday), and it was there in the morning at the time of the report, and the patient was just kind of waiting to see if it would get any better. So, he haven't done anything and was asking what he should do about that. Therapeutic measures were taken as a result of joint pain in his big toe on his left foot, which included that the patient took some paracetamol (TYLENOL), but it didn't really seem to help much, so he didn't take anymore. The patient had no investigation assessment. The patient was not recovered from the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,PUB,PROMETHAZINE,,Medical History/Concurrent Conditions: Sleep problem,,,['Arthralgia'],UNK,PFIZER\BIONTECH, 1067986,FL,74.0,F,"tenderness in area of injection; noted blotchy redness, no pain, extending 6 in below shot site; This is a spontaneous report from a contactable consumer who reported for herself. A 74-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL 9263) via an unspecified route of administration on 29Jan2021 at 19:30 (at the age of 74-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included HTN (hypertension), atherosclerosis, hip replacement, TIA (transient ischemic attack) and ""INCR"" lipids (increased lipids), all from unspecified dates and unspecified if ongoing. The patient had no known allergies to mediations, food or other products. Concomitant medications (received within 2 weeks of vaccination) included nebivolol hydrochloride (BYSTOLIC), lisinopril, calcium citrate (CITRACAL), ezetimibe (ZETIA) and pitavastatin calcium (LIVALO), all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced tenderness in area of injection and noted blotchy redness, no pain, extending 6 in below shot site, both on 29Jan2021 at 23:00, both reported as non-serious. The events did not cause hospitalization. The clinical course was reported as follows: ""tenderness in area of injection began hours after injection and increased over 24hrs and began to decease. 52hrs p shot noted blotchy redness, no pain, extending 6 in below shot site. Still there 18hrs later but fading in color."" No treatment was received for the events. It was reported that it was unknown whether the patient was recovered. The clinical outcomes of the events tenderness in area of injection and noted blotchy redness, no pain, extending 6 in below shot site were both unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/29/2021,0.0,PUB,BYSTOLIC; LISINOPRIL; CITRACAL; ZETIA; LIVALO,,Medical History/Concurrent Conditions: Atherosclerosis; Hip replacement; Hypertension; Lipids increased; TIA,,,"['Vaccination site erythema', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1067987,,22.0,F,"neck pain (base of skull); neck stiffness; nausea; hot flashes; general fatigue; feeling unwell; sick; This is a spontaneous report from a non-contactable consumer (patient). A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient was previously vaccinated with first dose of BNT162B2 on unspecified date at single use for COVID-19 immunization. The patient experienced neck pain (base of skull) / neck stiffness, nausea, hot flashes, general fatigue, feeling ""unwell"" and was sick on an unspecified date. The outcome of the events was recovered on unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and were not a congenital anomaly/birth defect. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Fatigue', 'Hot flush', 'Illness', 'Malaise', 'Musculoskeletal stiffness', 'Nausea', 'Neck pain']",2,PFIZER\BIONTECH, 1067988,CA,41.0,F,"heart rate suddenly increased; throat felt tight; felt very warm in the head and neck like was flushed; felt very warm in the head and neck like was flushed; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9265) via an unspecified route of administration in the left arm on 30Jan2021 10:30 am at a single dose as Covid vaccine. Medical history included known allergies to penicillin- anaphylaxis. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Approximately 5 minutes after injection, heart rate suddenly increased and throat felt tight, and felt very warm in the head and neck like was flushed on 30Jan2021 10:45 am. It passed after a minute or two, then happened again around five times within the hour after injection. No treatment was provided for the events. The patient had no Covid prior to vaccination and has not had Covid tested positive post vaccination. The outcome of the events was recovered on Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/30/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Anaphylaxis (known allergies to penicillin- anaphylaxis); Penicillin allergy (known allergies to penicillin- anaphylaxis),,,"['Feeling hot', 'Flushing', 'Heart rate', 'Heart rate increased', 'Throat tightness']",1,PFIZER\BIONTECH, 1067989,MO,51.0,M,"Blurry Vision; Headaches; Left ear pain; Loss of taste, smell; Loss of taste, smell; Insomnia; Fatigue; Joint pain; Neck pain; This is a spontaneous report from a contactable consumer reporting for himself. A 51-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunisation. Medical history included allergies to penicillin and COVID-19 prior to vaccination. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunization. Concomitant medication included unspecified drug. On 09Jan2021, the patient experienced blurry vision, headaches, left ear pain, loss of taste and smell, insomnia, fatigue, joint pain and neck pain. The patient received meloxicam as treatment medication. The events were considered as non-serious. The outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/09/2021,17.0,WRK,,,Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination); Penicillin allergy,,,"['Anosmia', 'Arthralgia', 'Dysgeusia', 'Ear pain', 'Fatigue', 'Headache', 'Insomnia', 'Neck pain', 'Vision blurred']",2,PFIZER\BIONTECH, 1067990,CA,58.0,F,"slight swelling; arm redness at injection site; chills; fever 103.8; weakness; headache; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL9262 and expiry date unknown, via unspecified route of administration at the left arm on 28Jan2021 11:15 at single dose for Covid-19 immunization in a hospital. Medical history included high blood pressure, depression, asthma, wheat allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included lisinopril, paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]), cyanocobalamin (VIT B12), ergocalciferol (VIT D); all from unspecified date for unspecified indication. The patient previously took amoxicilin, morphine, vicodin; all experienced drug allergy. Historical vaccine included first dose of BNT162B2 lot number EH9899 at the left arm on 07Jan2021 11:15 AM for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021 19:00, the patient experienced chills, fever 103.8 (temperature), weakness, headache, until 30Jan2021 6:30 am. Then again, on 30Jan2021 11 pm, the patient experienced fever, chills headache until 6:30 am. On 30Jan2021, the patient experienced arm redness at injection site. On 31Jan2021, the patient continued to experience redness and slight swelling (injection site). The patient has the patient been tested for COVID-19 since the vaccination. The patient did not received treatment for the events. The outcome of the events was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,PVT,LISINOPRIL; PAXIL [PAROXETINE HYDROCHLORIDE]; VIT B12; VIT D,,Medical History/Concurrent Conditions: Asthma; Blood pressure high; Depression; Food allergy,,,"['Asthenia', 'Body temperature', 'Chills', 'Headache', 'Pyrexia', 'Vaccination site erythema', 'Vaccination site swelling']",2,PFIZER\BIONTECH, 1067991,FL,67.0,F,"Covid test with nasal swab last week and it came back positive; Covid test with nasal swab last week and it came back positive; This is a spontaneous report from a contactable consumer (husband). A 67-year-old female patient (wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 09Jan2021 at a single dose as Covid-19 vaccine. There were no medical history and no concomitant medications. The reporter called and stated that he and his wife received the first dose of the Pfizer-BioNtech Covid-19 vaccine 3 weeks ago on 09Jan2021, they were ready to receive the second dose of the vaccine; however, last week his wife took a nose swab test and she was positive for Covid-19 on Jan2021. The patient did not visit physician office/emergency room. She felt fine. They would like to know if they could receive the second dose or if they should wait. They had the first shot (Covid-19 Vaccine by Pfizer) he and his wife, and they have an adult child living with them, he didn't qualify because of the age. Their 3 weeks were up and they had been notified to get the second shot, he and his wife, now in between she took a Covid test with nasal swab last week and it came back positive, could they still take it, the second shot? And then what were the chances with them having the first shot, was why she tested positive? No treatment was received for the events. The outcome of the events was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1067992,MO,32.0,F,"Fever; Migraine; Nausea; Throwing up; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot: EL3247), intramuscular on the left arm (at the age of 32years) on 27Jan2021 at 14:00 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included migraines, kidney stones and high cholesterol. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The reported adverse events were fever, migraine, nausea, and throwing up on 31Jan2021 with no treatment received on all events. The patient considered the events as non-serious. Did not results in death, non- life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and no congenital anomaly/birth defect. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/31/2021,4.0,UNK,,,Medical History/Concurrent Conditions: High cholesterol; Kidney stones; Migraine,,,"['Migraine', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,OT 1067993,WI,74.0,F,"light headed; slight headache; tired; Upper arm became sore and a bit swollen/Upper arm more swollen and sore.; Upper arm became sore and a bit swollen/Upper arm more swollen and sore.; Did not sleep well overnight (always do) and woke up very tired; sick to stomach; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3248, expiry date not reported), via an unspecified route of administration in the left arm on 30Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included Raynaud's phenomenon. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received fluvastatin sodium (LESCOL) and experienced drug hypersensitivity, and nifedipine (ADALAT) and experienced drug hypersensitivity. On 30Jan2021 17:30, in the evening the patient became light headed, had a slight headache and was tired. Her upper arm became sore and a bit swollen. She did not sleep well overnight (always do) and woke up very tired, sick to stomach. Her upper arm was more swollen and sore. No therapeutic measures was taken as a result of the events. Clinical outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Raynaud's phenomenon,,,"['Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pain in extremity', 'Peripheral swelling', 'Poor quality sleep']",UNK,PFIZER\BIONTECH, 1067994,DC,50.0,F,"Injection site pain; Chills; nausea; fever 99.5; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the right arm on 30Jan2021 10:00 at a single dose for COVID-19 immunization in a clinic. Medical history included high blood pressure and COVID-19 prior to vaccination. The patient was not pregnant. Concomitant medication included hydrochlorothiazide, lisinopril hydrochlorthiazid, loratadine, and fluticasone propionate (FLONASE). The patient experienced injection site pain, chills, nausea, fever 99.5 on 30Jan2021 10:00. The patient did not receive any treatment for the events. The patient was recovering from the events. Information on lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,SCH,LISINOPRIL HYDROCHLORTHIAZID; LORATADINE; FLONASE [FLUTICASONE PROPIONATE],,Medical History/Concurrent Conditions: Blood pressure high; COVID-19 (prior vaccination),,,"['Body temperature', 'Chills', 'Nausea', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1067995,TX,78.0,F,"Very dizzy (room spinning falling)/ Dizziness; Dry heaves; Briefly queasy; Brief feeling of coming down with cold; Sinus swelling; Quickly fatigued still here a week later; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration at the right arm on 23Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included environmental allergies (many), gastrooesophageal reflux disease, atrial tachycardia, blood pressure abnormal, cholecystectomy, hysterectomy, retinopexy, cellulitis, sepsis and pneumonia from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications included diltiazem, dexlansoprazole (DEXILANT), flecainide, hctz , and triamterene. The patient previously received and experienced allergies from ciprofloxacin hydrochloride (CIPRO), cefalexin (KEFLEX), tetracycline, sulfamethoxazole, trimethoprim (BACTRIM), glycopyrronium bromide (ROBINUL), doxycycline (DORYX), loratadine (CLARITIN), tetracycline hydrochloride (SUMYCIN), lisinopril and clindamycin hydrochloride (CLEOCIN). On the day of shot, on 23Jan2021 10:15 had a brief feeling of coming down with cold. Next day on 24Jan2021, the patient experienced briefly queasy, 3rd day fine, 4th day very dizzy (room spinning falling) and dry heaves. The patient also experienced dizziness, sinus swelling, and fatigued still here a week later. She took weekly immunotherapy shots for her multiple allergies. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 28Jan2021. Therapeutic measure was taken for all the events. Clinical outcome of the events was not recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/01/2021,,UNK,DILTIAZEM; DEXILANT; FLECAINIDE; HCTZ; TRIAMTERENE,,Medical History/Concurrent Conditions: Atrial tachycardia; Blood pressure abnormal; Cellulitis; Detached retina repair; Environmental allergy; Gallbladder removal; GERD; Hysterectomy; Pneumonia; Sepsis,,,"['Dizziness', 'Fatigue', 'Nasopharyngitis', 'Nausea', 'Retching', 'SARS-CoV-2 test', 'Sinus disorder']",1,PFIZER\BIONTECH, 1067996,CA,83.0,M,"general feeling of unwellness; chill; headache; loss of balance; This is a spontaneous report from a contactable consumer (reported for himself). An 83-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL9262, expiry date not reported), via an unspecified route of administration on 26Jan2021 10:30 at a single dose in the left arm for Covid-19 immunization. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included quinapril at 5 mg, cyanocobalamin (B-12) at 2500 ug (2500 mcg), and atorvastatin at 40 mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 08:00 pm, patient experienced a general feeling of unwellness, chill, headache, and loss of balance. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the adverse events. The events recovered on an unspecified date in 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/27/2021,1.0,PUB,QUINAPRIL; B-12; ATORVASTATIN,,,,,"['Balance disorder', 'Chills', 'Headache', 'Malaise']",UNK,PFIZER\BIONTECH, 1067997,WI,54.0,F,"Uncontrollable chills; stabbing pain all over; headaches; body shakes; nausea; sensitivity to smells; motion; tired; This is a spontaneous report from a contactable healthcare professional. A 54-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: T23248), intramuscular in the left arm on 29Jan2021 at 10:00 AM as a single dose for COVID-19 immunization. Medical history included known allergies to sulfa. The patient did not have COVID prior to vaccination, had no other vaccine in four weeks and was not pregnant at the time of vaccination. Concomitant medications included multivitamins, ibuprofen, and paracetamol (TYLENOL). The patient received the first dose of BNT162B2 on 10Jan2021. On 29Jan2021 at 07:00 PM, the patient experienced uncontrollable chills, stabbing pain all over, headaches, body shakes, nausea, sensitivity to smells, ""motion"", and tired. The patient was not COVID tested after vaccination. The patient received no treatment for the events. Outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,PVT,IBUPROFEN; TYLENOL,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,"['Chills', 'Fatigue', 'Headache', 'Motion sickness', 'Nausea', 'Pain', 'Parosmia', 'Tremor']",2,PFIZER\BIONTECH,OT 1067998,,,F,"lot of pain went around muscle shoulder pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, first dose on Jan2021 at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced a lot of pain went around muscle shoulder pain on Jan2021. Patient took a paracetamol (TYLENOL) and takes aspirin. Patient was asking if it will reduce efficacy of vaccine dose and indicated that she will take second dose. The outcome of the event was unknown. Information about lot/batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,['Myalgia'],1,PFIZER\BIONTECH, 1067999,FL,72.0,F,"Pain in arm; This is a spontaneous report from a contactable consumer (patient herself). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: 1284, expiration date was unknown), via an unspecified route of administration in the left arm on 07Jan2021 at 16:00 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was the hospital. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Jan2021 at 16:00, the patient experienced pain in arm, which was still bad after more than 3 weeks. The patient assessed the event as non-serious. Therapeutic measures were taken as a result of pain in arm, which included paracetamol (TYLENOL) or ibuprofen (ADVIL). The patient was not recovered from the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/07/2021,0.0,PVT,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1068000,AZ,34.0,F,"Fever; chills; cold sweats; extremely achy body to the point where it was difficult to lift myself out of bed; extremely achy body to the point where it was difficult to lift myself out of bed; I also had extreme fatigue; I slept for almost 20 hours straight, and slept through work without waking up to call out; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1238), intramuscular from 28Jan2021 15:45 (03:45 PM), (at the age of 34-years-old) at single dose on left arm for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included bipolar 2 disorder (reported as ""ipolar 2 disorder"") and attention deficit hyperactivity disorder (ADHD). Patient has no allergies to medications, food and other products. Patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included lamotrigine (100 mg), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL; reported as ""Adderall XR 15 mg"") and quetiapine fumarate (50 mg). Patient did not received any other vaccines within 4 weeks prior vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as ""Other"". The patient received first dose of COVID-19 vaccine on 07Jan2021 01:00 PM (lot number: EH9899), intramuscular on the left arm. On 29Jan2021 02:00 AM, the patient experienced fever, chills, cold sweats, extremely achy body to the point where it was difficult to lift herself out of bed. The patient also had extreme fatigue. Patient slept for almost 20 hours straight, and slept through work without waking up to call out. No treatment was received for the events. The events were assessed as non-serious. Outcome of the events was recovered in 2021. Body temperature on 29Jan2021 with unknown results. Since the vaccination, the patient has not been tested for COVID-19",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/29/2021,1.0,PUB,LAMOTRIGINE; ADDERALL; QUETIAPINE FUMARATE,,Medical History/Concurrent Conditions: ADHD; Bipolar II disorder,,,"['Body temperature', 'Chills', 'Cold sweat', 'Fatigue', 'Hypersomnia', 'Mobility decreased', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH,OT 1068001,WI,51.0,F,"Left arm soreness; This is a spontaneous report from a contactable nurse (reporting for herself). A 51-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration from 28Jan2021 14:45 to 28Jan2021 14:45 at SINGLE DOSE for covid-19 immunization. The patient's medical history included Environmental allergies: some trees and grass. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), loratadine, pseudoephedrine sulfate (CLARITIN-D), montelukast sodium (SINGULAIR), diphenhydramine hydrochloride (BENADRYL), colecalciferol (VITAMIN D [COLECALCIFEROL]), all for unspecified indication. The previously took her first dose of bnt162b2 on 07Jan2021 (lot number: EL3248) on her left arm for covid-19 immunization. On 28Jan2021 at 17:30, the patient experienced Left arm soreness beginning a few hours after vaccine administration and lasting about another 24 hours. The outcome of the event was recovered on an unspecified date. The seriousness of the event was reported as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,PVT,WELLBUTRIN; CLARITIN-D; SINGULAIR; BENADRYL; VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: Allergy to plants (Environmental allergies: some trees and grass); Grass allergy (Environmental allergies: some trees and grass),,,['Pain in extremity'],2,PFIZER\BIONTECH, 1068002,GA,27.0,F,"My face broke out in hives; My face broke out in hives/were itchy and hot/ itching; My face broke out in hives/were itchy and hot; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247; expiry date: unknown) via an unspecified route of administration in the left arm, on 25Jan2021 at 09:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 04Jan2021 for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On Friday, 30Jan2021 at 11:00, the patient's face broke out in hives. They were itchy and hot, and it was sudden, over the course of 15 to 30 minutes after the itching, they appeared. The patient took cetirizine hydrochloride before bed and applied cooling balm. The hives were gone this morning. The events were considered non-serious. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/30/2021,5.0,PVT,,,,,,"['Feeling hot', 'Pruritus', 'Urticaria']",2,PFIZER\BIONTECH, 1068003,FL,,M,"Severe dizziness; Felt tired; off kilter; nausea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration in the left arm on 28Jan2021 15:00 at a single dose for covid-19 immunization at a Administration facility. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with Covid-19 prior to vaccination. The patient has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe dizziness upon awaking the following day (29Jan2021), which lessened as the day wore on. The patient also felt tired and off kilter all day with nausea from midday to night. The patient has not been tested for COVID-19 since the vaccination. The events were not treated. The outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/29/2021,1.0,PUB,,,,,,"['Dizziness', 'Fatigue', 'Malaise', 'Nausea']",1,PFIZER\BIONTECH, 1068004,MI,69.0,F,"raised bump on arm at injection site; Chest pain; This is a spontaneous report from a contactable consumer reported for herself (also reported as nurse). A 69-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiration date unknown) via an unspecified route of administration on the left arm on 25Jan2021 at 12:15 PM at a single dose for COVID-19 immunisation in the hospital. Medical history included asthma and hypertension (controlled), sulfa allergy all from an unknown date. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), simvastatin and spironolactone. The patient previously took propylene glycol and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced well defined raised bump on arm at injection site and chest pain both on 25Jan2021. It was reported that chest pain on the evening of 30Jan2021 resolved after 45 minutes after taking 2 aspirin, followed by 2 more after 30 minutes. The events were assessed as non-serious by the reporter. The patient was recovering from well defined raised bump on arm at injection site and chest pain. The patient has not been tested for COVID-19 since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,PVT,ADVAIR; SINGULAIR; SIMVASTATIN; SPIRONOLACTONE,,Medical History/Concurrent Conditions: Asthma; Hypertension; Sulfonamide allergy (Allergies: Sulfa),,,"['Chest pain', 'Vaccination site mass']",1,PFIZER\BIONTECH, 1068005,MD,28.0,F,"rash on right breast; swollen and painful axillary lymph node; swollen and painful axillary lymph node; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: ek5730; expiration date: unknown) at the vaccination age of 28-year-old via an unspecified route of administration in the right arm on 13Jan2021 10:00 at a single dose for covid-19 immunisation. The patient medical history was not reported. The patient diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. Concomitant medication included duloxetine hydrochloride (CYMBALTA), ibuprofen (ADVIL) and birth control medication. The patient first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: ek5730) at the vaccination age of 28-year-old via an unspecified route of administration in the right arm on 13Jan2021 10:00 at a single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital. On 15Jan2021, the patient had rash on right breast, and swollen and painful axillary lymph node. The patient did not receive treatment for the adverse events. The events were non-serious, and the events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/15/2021,2.0,UNK,CYMBALTA; ADVIL [IBUPROFEN],,,,,"['Lymph node pain', 'Lymphadenopathy', 'Rash']",2,PFIZER\BIONTECH, 1068006,,,M,"cold; I have a little cough; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as 85, unit unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient was asking if he can get the 2nd dose of vaccine if he ""has a cold"". The patient also reported that ""I have a little cough and I want to know if it is alright for me to take my second shot, I was supposed to take it in the morning, I have a cough and I wanted to know if is it all right me to take my second shot. I have a cold is it alright to take my second shot."" The outcome of the events was unknown. Information on lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Cough', 'Nasopharyngitis']",1,PFIZER\BIONTECH, 1068007,,,M,"dizziness; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age (reported as ""72"", unit not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular, on 30Jan2021, at single dose, for COVID-19 immunization. Medical history included vertigo (reported as ""vertigo real bad""). Concomitant medication included an unspecified blood thinner. On 30Jan2021, almost right away, the patient experienced dizziness. The patient was unsure if his dizziness was from the vaccine or from his history of vertigo. The patient also reported that he is taking a blood thinner and was not aware he needed to let his vaccination provider know until after he got his dose. He asked if he should be concerned. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,01/30/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Vertigo,,,['Dizziness'],1,PFIZER\BIONTECH,OT 1068008,IL,54.0,F,"Sore arm; body aches; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283; expiry date: unknown) via an unspecified route of administration in the left arm, on 25Jan2021 at 15:15, at a single dose, for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication was not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the workplace clinic. On 26Jan2021, at 04:00 AM, the patient experienced sore arm and body aches. The events were considered non-serious. The patient did not receive therapy for the events. Outcome of the events was unknown. The patient has not been tested for COVID-19 since vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/26/2021,1.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 1068009,WA,78.0,F,"some soreness in left arm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9261), via an unspecified route of administration on 25Jan2021 at 13:45 at a single dose on the left arm for COVID-19 immunization. Medical history included high blood pressure and a-fib (atrial fibrillation) both from an unknown date and unknown if ongoing. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medication included lisinopril (LISINOPRIL), amlodipine (AMLODIPINE), atenolol (ATENOLOL), apixaban (ELIQUIS). Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient experienced some soreness in left arm next day, 26Jan2021. The patient did not receive any treatment for the event. The outcome of the event was recovered. The event was reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/26/2021,1.0,PVT,LISINOPRIL; AMLODIPINE; ATENOLOL; ELIQUIS,,Medical History/Concurrent Conditions: AFib (a-fib); Blood pressure high,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1068010,PA,59.0,F,"diffuse pink rash with white bumps over back and abdomen, to a smaller degree on arms. Also pruritis on back abdomen arms and legs.; diffuse pink rash with white bumps over back and abdomen, to a smaller degree on arms. Also pruritis on back abdomen arms and legs.; Mild scratchy throat; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249), via an unspecified route of administration on 29Jan2021 13:15 at single dose (right arm) for COVID-19 immunization. Medical history included occasional gastric reflux and allergies. The patient was not pregnant. Patient had unspecified concomitant medications which was received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021, at 20:00, the patient developed a diffuse pink rash with white bumps over back and abdomen, to a smaller degree on arms. Also, pruritis on back abdomen arms and legs and mild scratchy throat. The patient noticed these symptoms several hours after injection and was worse on day 2. There was no treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Allergy; Gastroesophageal reflux,,,"['Rash papular', 'Rash pruritic', 'Throat irritation']",UNK,PFIZER\BIONTECH, 1068011,CA,94.0,F,"Cough; This is a spontaneous report from a consumer (patient). A 94-year-old female (also the age at vaccination) patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number not reported), via an unspecified route of administration in the right arm on 26Jan2021 12:00 PM at SINGLE DOSE for COVID-19 immunization. The patient is vaccinated at a public health department. The patient is not pregnant. No other vaccines in four weeks. No COVID prior to vaccination and not COVID tested post vaccination. Medical history included High blood pressure, High Cholesterol both from unknown and if ongoing. Concomitant medication included amlodipine and simvastatin (reported as other medications in two weeks). It was reported that the patient experienced cough on 27Jan2021 at 12:00 PM. No treatment was given. The outcome of the event was not recovered. Information about Batch/Lot number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,PUB,AMLODIPINE; SIMVASTATIN,,Medical History/Concurrent Conditions: Blood pressure high; High cholesterol,,,['Cough'],1,PFIZER\BIONTECH, 1068012,MN,46.0,F,"body aches/body aches and especially the throbbing in head became much worse by midday/achy; slight throbbing in head/throbbing in head became much worse by midday; very tired; body chills and hot sweats on and off; body chills and hot sweats on and off; still lethargic and achy but improving; slept all day, and all night; eye pain which was triggered by light and eye movements; eye pain which was triggered by light and eye movements; This is a spontaneous report received from a contactable nurse (who is also the patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 11:15, at single dose, for COVID-19 immunization, at an urgent care center. There was no medical history. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included probiotics. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: unknown) received at age 46 years, via an unspecified route of administration on the left arm, on 08Jan2021 11:15, for COVID-19 immunization. On 30Jan2021 at 07:00, the patient experienced body aches and slight throbbing in head which became worse by midday; was very tired; returned to bed within 30 minutes and slept all day, and all night; had eye pain which was triggered by light and eye movements; body chills and hot sweats of and off. The patient reported that although she never had a fever according to her non contact forehead thermometer, she had body chills and hot sweats on and off. 48 hours later, she was still lethargic and achy but improving. Treatment for the events included ibuprofen 600 mg every 4-5 hours which helped but did not completely relieve the discomforts. The patient was recovering from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,OTH,PROBIOTICS,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'Chills', 'Eye pain', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Hypersomnia', 'Lethargy', 'Pain', 'Photophobia']",2,PFIZER\BIONTECH, 1068013,KY,42.0,F,"Extreme muscle aches; fever; chills; headache; vomiting; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 29Jan2021 17:15 (at the age of 42-years-old) at single dose for COVID-19 immunization in the workplace clinic. Medical history included endometriosis, acid reflux, and history of blood clots. The patient had no known allergies. The patient was not pregnant. The patient did not have COVID prior to vaccination. Concomitant medication included methyldopa hydrochloride (ALDOMET [METHYLDOPA HYDROCHLORIDE]), omeprazole (PROTONIX [OMEPRAZOLE]), probiotics (PROBIOTICS), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and vitamins. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in the left arm on 08Jan2021 at 06:15 PM (at the age of 42-years-old) for COVID-19 immunization. The patient did not receive other vaccines in four weeks. The patient experienced extreme muscle aches, fever, chills, headache, vomiting on 30Jan2021 at 11:00 AM. The patient did not receive treatment for the events. The patient was not tested for COVID post vaccination. The outcome of the events was recovered in Jan2021. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,WRK,ALDOMET [METHYLDOPA HYDROCHLORIDE]; PROTONIX [OMEPRAZOLE]; PROBIOTICS; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Acid reflux (oesophageal); Clot blood; Endometriosis,,,"['Chills', 'Headache', 'Myalgia', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,OT 1068014,OK,34.0,F,"Right Lymph node breast swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL1283, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 11Jan2021 for COVID-19 immunization. Facility Type Vaccine: Hospital. The patient had no relevant history and had no known allergies. The patient was not pregnant at the time of vaccination and at the time of reporting. The patient did not have Covid prior vaccination. There was no other vaccine given within four weeks; and no other medications given within two weeks. On 19Jan2021 09:00 AM, the patient experienced right lymph node breast swelling. No treatment was given for the adverse event. The patient was not Covid tested post vaccination. The patient recovered from the event on an unspecified date in 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/19/2021,8.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['Lymphadenopathy'],1,PFIZER\BIONTECH, 1068015,FL,,M,"chills; aches; malaise; headache; tingling in right arm for about 3-4 minutes/ vaccine location=Right arm; This is a spontaneous report from a contactable nurse. An adult male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on 08Jan2021 at a single dose in right arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) on 18Dec2020 at a single dose for COVID-19 immunization. About 12.5 hours after patient received the second dose (Lot EL1284) on 08Jan2021, he had tingling in right arm for about 3-4 minutes. When he went to work that next morning (09Jan2021) he started to develop chills, aches, malaise, and a headache around 0930/1000, about 24 hours after receiving the second dose. He did not become febrile at all after receiving the second the dose. The chills, aches, and malaise resolved within six hours after taking some Ibuprofen. The headache lasted for the next two days, with the worst of it being that Sunday (10Jan2021). It resolved the next day. Therapeutic measures were taken as a result of the events chills, aches, malaise, and headache which included ibuprofen. No treatment for vaccination site paresthesia. The outcome of the events was recovered on Jan2021. Facility type Vaccine was Hospital. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. COVID tested post vaccination with Nasal Swab, covid test result is Negative.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,,,,,,"['Chills', 'Headache', 'Malaise', 'Pain', 'SARS-CoV-2 antibody test', 'Vaccination site paraesthesia']",2,PFIZER\BIONTECH,OT 1068016,,,F,"COPD; osteoarthritis; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Jan2021 at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced chronic obstructive pulmonary disease (COPD) and osteoarthritis which she takes 800 mg ibuprofen and inhaler as treatment. Furthermore, an antibiotic doxycycline. Asking if she should reduce medications. Therapeutic measures were taken as a result of COPD and osteoarthritis. The outcome of all the events was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,,,UNK,,,,,,"['Chronic obstructive pulmonary disease', 'Osteoarthritis']",1,PFIZER\BIONTECH, 1068017,UT,41.0,F,"Filler swelling (face); This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El9265, expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 17:00, at single dose, for covid-19 immunization, at a public health department. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date: unknown) received at 41 years of age, via an unspecified route of administration on the right arm, on 08Jan2021 17:00, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 31Jan2021, the patient experienced filler swelling (face) (pending clarification). It was unknown if treatment was received for the event. The outcome of the event was not recovered. The reporter assessed the event as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/31/2021,2.0,PUB,,,Medical History/Concurrent Conditions: Hypothyroidism,,,['Swelling face'],2,PFIZER\BIONTECH, 1068018,CA,34.0,M,"swollen glands left side only; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number ej1686 and expiry date unknown, via unspecified route of administration at the left arm on 11Jan2021 12:00 PM at single dose for Covid-19 immunization in a hospital. Medical history was none. The patient's concomitant medications were not reported. The patient has no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 12:00 PM, the patient experienced swollen glands left side only. The patient has not been tested for COVID-19 since vaccination. The patient did not received treatment due to the events. The outcome of the event was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/30/2021,19.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['Lymphadenopathy'],1,PFIZER\BIONTECH, 1068019,MO,42.0,F,"I experienced sharp pain laterally through my deltoid muscle; ached/painful/ douloureux; Higher than normal blood sugar; This is a spontaneous report from a contactable consumer (patient herself). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not provided), via an unspecified route of administration in left arm on 27Jan2021 14:00 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. She had no allergies to medications, food, or other products. She was not pregnant. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of vaccination. The patient stated ""I experienced sharp pain laterally through my deltoid muscle, ached/painful, and higher than normal blood sugar"" on 27Jan2021 14:30. The events were reported as non-serious and no treatment was received. The outcome of the events was recovering. The patient had not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,UNK,,,,,,"['Blood glucose increased', 'Myalgia', 'Pain']",1,PFIZER\BIONTECH, 1068020,,,F,"skin on head started to feel itchy; urticaria on her body; some rash on the area on front of both thighs; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After 3 days since he vaccination, on Jan2021, patient's skin on head started to feel itchy, and it lasted for so many days, and recently her body feels itchy too. After that she checked her body and found urticaria on her body, under arm pit of both armpit, vaccination side was on her left side, on her belly in some areas, and there was also some rash on the area on front of both thighs. There was also in her head, beneath her hair. Patient had never had before the Covid vaccine and was still experiencing those effects. Outcome of the events was unknown. Patient was due to go back 08Feb2020 of the second dose No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,01/01/2021,,UNK,,,,,,"['Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH, 1068021,AZ,,M,"fatigue/tiredness on second day after shot; This is a spontaneous report from a contactable consumer (patient). A 90-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration at right arm on 30Jan2021 10:45 at single dose for COVID-19 immunization. Medical history included Congestive heart failure (CHF). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On 31Jan2021 13:00, the patient experienced fatigue/tiredness on second day after shot. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,01/31/2021,1.0,PUB,,,Medical History/Concurrent Conditions: Congestive heart failure,,,['Fatigue'],1,PFIZER\BIONTECH, 1068022,NJ,53.0,M,"Light fever; sore throat; chills; feeling unwell; tiredness; Sleepy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the left arm on 28Jan2021 16:45 at single dose for COVID-19 immunization. Medical history included open heart surgery and being diabetic. Concomitant medication included metformin, sitagliptin (JANUVIA), acetylsalicylic acid (ASPRIN), atorvastatin, and fenofibrate (TRICOR). The patient previously took moxifloxacin (AVELOX), levofloxaxin (LEVAQUIN), ciprofloxacin (CIPRO), and cloxacillin sodium (LOXACIN) and experienced allergies. The patient experienced light fever, sore throat, chills, feeling unwell, tiredness, and sleepy on 28Jan2021 16:45. The patient did not receive treatment for the events. The outcome of the events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,UNK,METFORMIN; JANUVIA; ASPRIN; ATORVASTATIN; TRICOR,,Medical History/Concurrent Conditions: Diabetes; Open heart surgery,,,"['Chills', 'Fatigue', 'Malaise', 'Oropharyngeal pain', 'Pyrexia', 'Somnolence']",UNK,PFIZER\BIONTECH, 1068023,,,F,"tingling; throbbing; pressure on the top and back of her head; This is a spontaneous report from a contactable nurse (patient). A female patient of unspecified age (39, age unit unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot and expiry were not reported), via an unspecified route of administration on 25Dec2020 at single dose for COVID-19 immunization. The patient's medical history were not reported. Concomitant medication included paracetamol (TYLENOL) as prophylaxis on 25Dec2020. The patient called to report her side effects after receiving the Covid vaccine. She received the first dose of the Covid vaccine on 25Dec2020, in which she prophylactically took 1000 mg of paracetamol. The patient reported tingling, throbbing, and pressure on the top and back of her head on unspecified dates. The patient stated that this feeling would subside and then come back. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/25/2020,,,UNK,TYLENOL,,,,,"['Head discomfort', 'Pain', 'Paraesthesia']",1,PFIZER\BIONTECH, 1068024,WA,66.0,F,"feel a cold sensation in my groin and in my upper thighs; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration at right arm on 31Jan2021 09:45 at a single dose for COVID-19 immunisation. Medical history included liver damage from hepatitis C. Concomitant medications were not reported. On 31Jan2021, the patient reported that she felt fine and walked back to her vehicle. As she began to drive home (after an additional 5 minutes), the patient began to feel a cold sensation in her groin and in her upper thighs. It continued for about 1/2 hour and then subsided. No treatment was received. The outcome of the event was recovered on an unspecified date. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/31/2021,01/31/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Hepatitis C; Liver damage,,,['Feeling cold'],1,PFIZER\BIONTECH, 1068025,KY,64.0,M,"Higher than normal blood sugar; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 31Jan2021 08:30 (at 64-year-old) at single dose for COVID-19 immunization. Medical history included Type 2 diabetes. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication was not reported. Patient received Diabetes medication within 2 weeks of vaccination. The patient previously took Percocet and Bactrim, and experienced drug allergy for both. The patient experienced higher than normal blood sugar on 31Jan2021 10:30. Therapeutic measures were taken as a result of higher than normal blood sugar, patient took extra insulin. The outcome of the event was recovering. Event was reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,01/31/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Type 2 diabetes mellitus,,,"['Blood glucose', 'Blood glucose increased']",UNK,PFIZER\BIONTECH, 1068026,,30.0,F,"extreme stomach cramps; vomiting; dizzy; headache; chills; This is a spontaneous report from a non-contactable other health professional (patient). A 30-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL3302 and expiry date unknown, via unspecified route of administration on 28Jan2021 14:30 at single dose for Covid-19 immunization in a workplace clinic. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior vaccination. Historical vaccine included first dose of BNT162B2 lot number EL1284 on 01Jan2021 for Covid-19 immunization. The patient received other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021, the patient experienced extreme stomach cramps, vomiting, dizzy, headache, chills. The patient did not received treatment for the adverse events. The patient has not been tested for COVID-19 since vaccination. The outcome of the events was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,WRK,,,,,,"['Abdominal pain upper', 'Chills', 'Dizziness', 'Headache', 'Vomiting']",2,PFIZER\BIONTECH, 1068027,CA,61.0,F,"shortness of breath, tingling feeling in lip and face; shortness of breath, tingling feeling in lip and face; shortness of breath, tingling feeling in lip and face; This is a spontaneous report from a contactable other healthcare professional (HCP) who reported for herself. A 61-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscularly on 20Jan2021 at 14:45 (at the age of 61-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included restless leg syndrome from an unspecified date and unspecified if ongoing. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications (received within 2 weeks of vaccination) included tretinoin (RETIN A; skin cream), biotin, vitamin D NOS, calcium and multivitamin, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced shortness of breath, tingling feeling in lip and face, all on 20Jan2021, all reported as non-serious. The events did not cause hospitalization. No treatment was received for the events. The clinical outcomes of the events shortness of breath, tingling feeling in lip and face were all unknown. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/20/2021,0.0,PUB,RETIN A; BIOTIN; VITAMIN D NOS; CALCIUM,,Medical History/Concurrent Conditions: Restless leg syndrome,,,"['Dyspnoea', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH,OT 1068028,NJ,42.0,M,"Nasal congestion; sore throat; This is a spontaneous report from a contactable consumer (reported for himself). A 42-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 29Jan2021 08:30 at a single dose in the left arm for covid-19 immunization. Medical history included diabetic and traumatic brain injury, both from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021, the patient experienced nasal congestion and sore throat. No treatment received for the adverse events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The events were reported as not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,PUB,,,Medical History/Concurrent Conditions: Diabetic; Traumatic brain injury,,,"['Nasal congestion', 'Oropharyngeal pain']",1,PFIZER\BIONTECH, 1068029,VA,29.0,F,"sore arm; diarrhea; sore rib; lump on neck; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: Ek4176), via an unspecified route of administration in the left arm on 12Jan2021 at 16:45 as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, PCOS (polycystic ovaries), and allergy to penicillin. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine, was not diagnosed with COVID-19 prior to vaccination, and was not pregnant at the time of vaccination. Concomitant medications included levothyroxine, metformin, and daily multivitamins (also reported as medication that the patient received within two weeks of vaccination). After the first dose, on 15Jan2021, the patient experienced sore arm, diarrhea starting day 3 through today, sore rib, and lump on neck. It was unknown if the events were treated. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/15/2021,3.0,PVT,LEVOTHYROXINE; METFORMIN,,Medical History/Concurrent Conditions: Hypothyroidism; Penicillin allergy; Polycystic ovarian syndrome (PCOS),,,"['Diarrhoea', 'Musculoskeletal chest pain', 'Neoplasm', 'Pain in extremity']",1,PFIZER\BIONTECH, 1068030,,70.0,F,"rash on legs, arms, chest and stomach; headache; fever; chills; body ache; 3 days with out sleeping; This is a spontaneous report from a non-contactable consumer (patient herself) via Medical Information team. A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Relevant medical history included anaphylaxis with insect bites from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took codeine and diazepam (VALIUM) and experienced hyperkinetic reaction. The patient stated that she received the vaccine on 14Jan2021, and that day 6 hours later, she had headache, fever, chills and body ache; and the next day on 15Jan2021, when she woke up, she had rash on legs, arms, chest and stomach, and she still had the rash. On an unspecified date, the patient had 3 days with out sleeping. The patient assessed the events as non-serious. The patient further reported that she was hyperkinetic and she has had that reaction many years prior reporting, before when taking codeine or VALIUM, one of the ingredients in VALIUM. She went to the doctor the first day, who saw her rash and told her to report that. It was not itching. The patient had the appointment for the second dose of the Pfizer vaccine, this coming Thursday and wanted to know if there would be a problem to get the second dose. She was afraid to get the vaccine the first time, because she had a history of anaphylaxis with insect bites. She carried an epi pen, and the vaccine provider had one too and the paramedics was there, and everything was okay; they were nice with her. The patient didn't have any problem until later. The patient spoke to her health care professional and he thought it was okay for her to get the second dose and the health care professional just told her to put a cream on her rash. Therapeutic measures were taken as a result of rash on legs, arms, chest and stomach, which included putting a cream on her rash. The patient was not recovered from the rash on legs, arms, chest and stomach, while the outcome of the events ""headache, fever, chills, body ache, and 3 days with out sleeping"" was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Anaphylaxis; Arthropod bite,,,"['Chills', 'Headache', 'Insomnia', 'Pain', 'Pyrexia', 'Rash']",1,PFIZER\BIONTECH, 1068031,CO,79.0,F,"shaking chills (rigor) 12H post shot; muscle aches; headache; fatigue (slept all next day); brain fog; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: el3247 and expiry date: unknown), via an unspecified route of administration on 28Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included mild asthma and mild hypertension. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccine and had unspecified medications within 2 weeks. The patient experienced shaking chills (rigor) 12H post shot, lasted 3 hrs; also has muscle aches, headache (3days), fatigue (slept all next day), brain fog on 28Jan2021 23:00. Outcome of the events was recovering. Patient took ibuprofen 36 hours after shot as treatment for the adverse events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Asthma; Hypertension,,,"['Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Myalgia']",UNK,PFIZER\BIONTECH, 1068032,PA,26.0,F,"Severe injection site swelling (grapefruit size); Nose bleed; Fever of 102; Lethargy; Tachycardia; Shortness of Breath; Severe joint pain; Migraine; Muscle pain; This is a spontaneous report from a contactable other healthcare professional (HCP reporting for self). A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 11:30 at a single dose in the right arm for COVID-19 immunization. Other medical history and known allergies were reported as none. The patient had no COVID prior vaccination. The patient was not pregnant at the time of the report and vaccination. Concomitant medications included zinc, ascorbic acid (VIT C), ergocalciferol (VIT D) and an unspecified birth control medication. The first dose of BNT162B2 (brand: Pfizer as reported) was received on 06Jan2021 12:00 PM in the left arm for COVID-19 immunization. The patient had no other vaccine in the four weeks prior to second dose vaccination. On 27Jan2021 23:00, the patient experienced nose bleed, fever of 102, severe injection site swelling (grapefruit size), lethargy, tachycardia, shortness of breath, severe joint pain, migraine and muscle pain. The patient did not receive treatments for the reported adverse events. Patient had COVID test post vaccination specified as nasal swab on 27Jan2021 with test result as negative. The events were reported as recovered with lasting effects. Information on the Lot/Batch number has been requested.; Sender's Comments: Considering the close drug-event temporal association and the location, the reasonable possibility that the reported severe injection site swelling is related to BNT162B2 seems likely.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,SEN,ZINC; VIT C; VIT D,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Body temperature', 'Dyspnoea', 'Epistaxis', 'Lethargy', 'Migraine', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test', 'Tachycardia', 'Vaccination site swelling']",2,PFIZER\BIONTECH, 1068033,,74.0,F,"a rash all over [her] body; A swelling face; Being tired; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, batch/lot number and expiry date unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient experienced a rash all over her body, a swelling face, and being tired on an unspecified date after receiving the first dose of the COVID-19 vaccine. She said that her throat was ok, hadn't itch and she doesn't have a fever. The outcome of the events was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,,,UNK,BENADRYL,,,,,"['Fatigue', 'Rash', 'Swelling face']",1,PFIZER\BIONTECH, 1068034,CA,56.0,M,"I had some pretty bad flu like symptoms/Began to have flu like symptoms, pretty severe flu like symptoms; pain; This is a spontaneous report from a contactable nurse (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, via an unspecified route of administration on 08Jan2021 (first dose, lot/batch number: EL1284, expiry date: Apr2021) at a single dose, then via an unspecified route of administration on 29Jan2021 (second dose, lot/batch number: EL1284 , expiry date: Apr2021) at a single dose for Covid-19 immunization. Medical history included was reported as none. There were no concomitant medications. Patient received his first vaccine on the 8th of this month and the second dose the 29th of this month. On both occasions for 3 days after the vaccine, he had some pretty bad flu like symptoms. He began to have flu like symptoms, pretty severe flu like symptoms and pain on 09Jan2021. He stated taking some Ibuprofen 400mg, every 8 hours as needed for pain. Outcome of the event flu like symptoms was not recovered while pain was unknown at the time of the report. No follow-up activities are needed. No further information is expected. Information regarding the lot/batch number has been obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Influenza like illness', 'Pain']",1,PFIZER\BIONTECH, 1068035,TX,,F,"think they might have been exposed to COVID-19 after receiving the vaccine; slight headache; a little bit of fever; little of bit of cold; chills; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient and her husband were near to a person who was diagnosed with COVID-19; but they haven't been tested for COVID-19, they think they might have been exposed to COVID-19 after receiving the vaccine. She asked if they would test positive for COVID-19 after the exposure and if that was the case, would their doctor defer or re-schedule their second dose which was currently scheduled for 15Feb2021. On an unspecified date after getting first dose of the COVID-19 vaccine, the patient experienced a slight headache and a little bit of fever, little of bit of cold and chills. The outcome of the event ""think they might have been exposed to COVID-19 after receiving the vaccine"" was unknown while the outcome of all other events was recovered on an unspecified date. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,,,UNK,,,,,,"['Chills', 'Exposure to SARS-CoV-2', 'Feeling cold', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH, 1068036,MA,71.0,M,"Anxiety; tiredness; headache; chills; nausea; feeling unwell; This is a spontaneous report from a contactable healthcare professional (patient). A 71-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) solution for injection, intramuscular on right arm on 26Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included chronic back pain. The patient has no allergies to medications, food, or other products. Concomitant medications included unspecified blood pressure and pain medications which he received within 2 weeks of vaccination. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular at left arm on 05Jan2021 at 2:00 PM at single dose for COVID-19 immunization and experienced headaches for a week. The patient received his most recent COVID-19 vaccine at a hospital. He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 28Jan2021 at 06:00 AM, the patient experienced anxiety, tiredness, headache, chills, nausea, and feeling unwell. All these feelings come and go but made him very uncomfortable. He was told that it would dissipate in 48 hours. There was no treatment received in response to the events. The outcome of the events was not recovered. The events were assessed as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/28/2021,2.0,PVT,,,Medical History/Concurrent Conditions: Chronic back pain,,,"['Anxiety', 'Chills', 'Fatigue', 'Headache', 'Malaise', 'Nausea']",2,PFIZER\BIONTECH,OT 1068037,IL,34.0,F,"left arm completely numb; tingling; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL1284 and expiry date unknown, via unspecified route of administration at the left arm on 30Dec2020 12:30 at single dose for Covid-19 immunization in a workplace clinic. Medical history included sinusitis, placenta precreta, infertility, C-section, sulfa allergy, seasonal allergy. The patient's concomitant medications were not reported. The patient previously took hydrocodone, coriander oil; both experienced allergies. The patient had no other vaccine in four weeks. On 31Dec2020 06:00, the patient experienced left arm completely numb and tingling for 4 weeks. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment due to the events. The patient underwent lab tests and procedures which included nasal swab (Covid-19): negative on 26Jan2021. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,12/31/2020,1.0,WRK,,,Medical History/Concurrent Conditions: C-section; Infertility; Placental disorder; Seasonal allergy; Sinusitis; Sulfonamide allergy,,,"['Hypoaesthesia', 'Paraesthesia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068038,,32.0,M,"Body aches; headache; fatigue; This is a spontaneous report from a non-contactable other health professional reporting for himself. A 32-year-old male patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot# el9263), via an unspecified route of administration in the left arm, on 24Jan2021, at single dose, for COVID-19 immunisation. Medical history included penicillin allergy. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced body aches, headache and fatigue all on 31Jan2021 at 15:30 with outcome of not recovered. No therapeutic measures were taken as a result of the events. Since vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/31/2021,7.0,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Fatigue', 'Headache', 'Pain']",1,PFIZER\BIONTECH, 1068039,CA,65.0,M,"Very achy for next 2 days; triggered what I believe could be a very bad sciatica situation; Both legs ache, sitting feels like cuts off circulation, standing hurts less but hurts. Leaning forward front of legs hurt, standing flat, back of legs hurt; Have not been able to sleep for last 3 days due to the pain; This is a spontaneous report from a contactable consumer who reported for himself, a 65-year-old male patient who received the first fose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm, on 28Jan2021 at 15:30, at the age of 65 years, at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had no known allergies. Patient was very achy for next 2 days, that seems consistent with all he have read. Reaction to vaccine has transitioned to or triggered what he believe could be a very bad sciatica situation. Both legs ache, sitting feels like cuts off circulation, standing hurts less but hurts. Leaning forward front of legs hurt, standing flat, back of legs hurt. Have not been able to sleep for last 3 days due to the pain. Tried lying on back, side, with pillows under legs, on floor with legs up on a chair. Have never had sciatica issue before. Patient experienced all reported events on 28Jan2021 at 19:30. The patient asked what can be done to eliminate the pain. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. No treatment was received for the events. The outcome of the events was not recovered. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Pain', 'Pain in extremity', 'Sciatica', 'Sleep disorder due to a general medical condition']",1,PFIZER\BIONTECH, 1068040,OH,82.0,F,"Bright red rash; large welts covering across butt; purple in spots; Chills; fatigue; Loss appetite; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, batch/lot number and expiration date not reported), via an unspecified route of administration (vaccine location: left arm) on 27Jan2021 10:00 for COVID-19 immunization. Facility type Vaccine: Pharmacy/Drug Store. Medical history included high blood pressure and heart surgery in past. The patient was not pregnant at the time of vaccination and at the time of reporting. The patient had no known allergies. The patient had no Covid prior vaccination. Concomitant medications/ other medications included metoprolol, rosuvastatin, and OTC anti acid. There was no other vaccine given withiin four weeks. On 27Jan2021 23:00, the patient experienced chills, fatigue and loss appetite; bright red rash and large welts covering across butt - needed to seek treatment at urgent care. It was now 4 days later and still present and purple in spots. Prescription cream (unspecified) was given. The outcome of events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,PHM,METOPROLOL; ROSUVASTATIN,,Medical History/Concurrent Conditions: Blood pressure high; Surgery,,,"['Chills', 'Decreased appetite', 'Fatigue', 'Rash erythematous', 'Rash macular', 'Urticaria']",1,PFIZER\BIONTECH, 1068041,MI,21.0,F,"Severe headache; Nausea; Myalgia; sore/itchy throat; Sore/itchy throat; Fever and chills within 3-4 post vaccination; Fever and chills within 3-4 post vaccination; This is a spontaneous report from a contactable healthcare professional who reported for herself, a 21-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), intramuscular in the right arm, on 30Jan2021 at 18:30, at the age of 21 years, at a single dose for COVID-19 immunization. Medical history included asthma, and known allergies to azithromycin (ZITHROMAX) and sulfa. The patient was not pregnant, and not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. On 30Jan2021 at 21:30, the patient experienced fever and chills within 3-4 post vaccination. The patient experienced severe headache, nausea, myalgia, and sore/itchy throat the next day, on 31Jan2021. No treatment was received for the events. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,PVT,,,"Medical History/Concurrent Conditions: Asthma; Sulfonamide allergy (Known allergies: Zithromax, sulfa)",,,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Pyrexia', 'Throat irritation']",2,PFIZER\BIONTECH,OT 1068042,,55.0,F,"Headaches; Chills/shivering; Nauseated; Body aches; This is a spontaneous report from a contactable consumer (patient) reported that a 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 11:00 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. After dinner of 30Jan2021, the patient started having symptoms listed as headaches, chills, nauseated, and body aches. She described her chills as being so bad that she woke up last night shivering. She said the nausea and body aches come and go. She asked how long will her symptoms last. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,01/30/2021,0.0,UNK,,,,,,"['Chills', 'Headache', 'Nausea', 'Pain']",2,PFIZER\BIONTECH, 1068043,CA,38.0,F,"Severe body aches and headaches 12 hours after administration of 2nd dose.; Severe body aches and headaches 12 hours after administration of 2nd dose.; First dose's administration date 13Jan2021, second dose's administration date: 30Jan2021; First dose's administration date 13Jan2021, second dose's administration date: 30Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262, expiry date: not reported), via an unspecified route of administration at left arm on 30Jan2021 at SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included polycystic ovary syndrome (PCOS), gilbert's syndrome, bipolar disorder, and allergies to sulfa. The patient received unspecified concomitant medication received within 2 weeks of vaccination. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1283), at left arm on 13Jan2021 at 06:30 PM for COVID-19 Immunisation. On 31Jan2021 at 04:30 AM, the patient experienced severe body aches and headaches 12 hours after administration of 2nd dose. The reporter considered the events non-serious. There was no treatment received for the events. It was also reported that since the vaccination, the patient has not been tested for COVID-19. The outcome of the events severe body aches and headaches was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,01/30/2021,0.0,PUB,,,Medical History/Concurrent Conditions: Bipolar disorder; Gilbert's syndrome; Polycystic ovary; Sulfonamide allergy,,,"['Headache', 'Inappropriate schedule of product administration', 'Off label use', 'Pain']",2,PFIZER\BIONTECH, 1068044,OH,75.0,F,"Runny nose; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included citalopram hydrobromide (CELEXA). The patient experienced runny nose on 29Jan2021 08:00. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,01/29/2021,,PVT,CELEXA [CITALOPRAM HYDROBROMIDE],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Rhinorrhoea'],UNK,PFIZER\BIONTECH, 1068045,AZ,68.0,F,"the injection site is still slightly pink and itches several times a day/ it was a little tender to touch; the injection site is still slightly pink and itches several times a day/ it was a little tender to touch; the injection site is still slightly pink and itches several times a day/ it was a little tender to touch; This is a spontaneous report from a contactable consumer (reporting for herself). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL 1284, expiration date unknown) via an unspecified route of administration in the left arm on 17Jan2021 19:00 (at 68 years old) at a SINGLE DOSE for COVID-19 immunization. The patient was vaccinated in other vaccination facility. Medical history included controlled high blood pressure and allergies to Asprin and Acetaminophen, all from an unknown date. Patient was not pregnant at the time of vaccination. Concomitant medications included calcium, diltiazem 280, lisinopril, and ""AREDS."" The patient received these medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior to vaccination, did not receive any other vaccines within 4 weeks prior to BNT162B2, and has not been tested for COVID post vaccination. The patient reported that the adverse events started on 17Jan2021. It's been two (2) weeks since her first vaccine, and the injection site is still slightly pink and itches several times a day. At first, she thought it was a bug bite. It was a little tender to touch. Outcome of the events was recovering. The events were reported as Non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/17/2021,01/17/2021,0.0,UNK,CALCIUM; DILTIAZEM; LISINOPRIL,,Medical History/Concurrent Conditions: Blood pressure high (controlled high blood pressure),,,"['Vaccination site discolouration', 'Vaccination site pain', 'Vaccination site pruritus']",1,PFIZER\BIONTECH, 1068046,CA,81.0,F,"tired/very tired; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265, expiry date: unknown), via an unspecified route of administration on 28Jan2021 13:45 (at the age of 81 years old) at a single dose in the left arm for covid-19 immunisation. Medical history included obesity. The patient's concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since the vaccination. The patient had no known allergies. On 30Jan2021, the patient experienced tired and following day very tired from which she slept five hours during the day. The patient did not receive any treatment for the event. Outcome of the event was unknown. Event was reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/30/2021,2.0,UNK,,,Medical History/Concurrent Conditions: Obesity,,,['Fatigue'],1,PFIZER\BIONTECH, 1068047,TX,35.0,F,"Couldn't take a full breath. Most intense standing or laying down, lesser when seated/when exercising like I can't take a big enough breathe; Centralized chest pain on sternum.; Felt extremely heavy, not like a regular flu. More like as asthma attack that was waiting to peak; Felt extremely heavy, not like a regular flu. More like as asthma attack that was waiting to peak; Arm soreness; Nauseous all week; loss of appetite; Sore to touch; heavy chested; medical history included Hashimoto's; medical history included Hashimoto's; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318; expiration date not provided), via an unspecified route of administration on 25Jan2021 19:00 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history included Hashimoto's, asthma, and food allergy all from unknown dates and unknown if ongoing. The patient has no COVID prior vaccination. The patient was not COVID tested post vaccination. Patient is not pregnant. Concomitant medications included levothyroxine sodium, liothyronine sodium, progesteron, and sertraline. Adverse events on 26Jan2021 at 07:00 were reported as follows: Centralized chest pain on sternum. Felt extremely heavy, not like a regular flu. More like as asthma attack that was waiting to peak (patient reported that she has asthma). Sore to touch. Couldn't take a full breath, most intense standing or laying down, lesser when seated. Lasted just over 48 hours. Patient also stated, 'Still feel heavy chested when exercising like I can't take a big enough breathe'. Patient also reported arm soreness, nauseous all week, loss of appetite. Also on period. The patient has not received treatment for the events. Outcome of the events was reported as 'Recovered with lasting effects'.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,SCH,LEVOTHYROXINE SODIUM; LIOTHYRONINE SODIUM; PROGESTERON; SERTRALINE,,Medical History/Concurrent Conditions: Asthma; Food allergy; Hashimoto's disease,,,"['Asthma', 'Chest discomfort', 'Chest pain', 'Decreased appetite', 'Dyspnoea', 'Influenza', 'Nausea', 'Off label use', 'Pain', 'Pain in extremity', 'Product use issue']",1,PFIZER\BIONTECH, 1068048,MI,50.0,F,"lightheaded; tired; achy; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration in right arm on 22Jan2021 19:00 at a single dose for Covid-19 immunization. Medical history included borderline hypertension and allergies to latex. Patient was not pregnant. Concomitant medications included atorvastatin, lisinopril, and fish oil. The patient previously took morphine and had allergy. Patient reported that the day after the vaccination, she experienced lightheaded, tired, and achy at 2pm on 23Jan2021. She had these symptoms every day since. Some days it happens more often than others. It happens at different times such as lying down, walking, etc. No treatment was given. Outcome of the events was not recovered. Information regarding the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/23/2021,1.0,PVT,ATORVASTATIN; LISINOPRIL; FISH OIL,,Medical History/Concurrent Conditions: Borderline hypertension; Latex allergy,,,"['Dizziness', 'Fatigue', 'Pain']",1,PFIZER\BIONTECH, 1068049,VA,20.0,M,"103 fever; Chills; horrible headache; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received first single dose of BNT162B2 (Pfizer, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: left arm) on 30Jan2021 15:45 for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: School or Student Health Clinic. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications received within 2 weeks of vaccination. On 31Jan2021, the patient experienced chills, horrible headache and 103 fever. The events were considered as non-serious by the reporter. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/31/2021,1.0,SCH,,,,,,"['Body temperature', 'Chills', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH, 1068050,IL,42.0,F,"Bad headache; pain at location of injection; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number E13302), via an unspecified route of administration (arm right) on 15Jan2021 11:30 SINGLE DOSE for covid-19 immunisation, at 42 years old. Medical history reported as none. The patient is not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient has no reported allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE), therapy date and indication unknown (received withing 2 weeks). The patient experienced bad headache lasting over 24 hours, pain at location of injection for two days, and diarrhea on 15Jan2021 11:30. Treatment was not given. Outcome of the events was recovered on Jan2021. The reporter considered the events as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,SCH,BLISOVI FE,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Diarrhoea', 'Headache', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1068051,CA,47.0,F,"numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE); felt acutely short of breath and anxious; felt acutely short of breath and anxious; numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE); This is a spontaneous report from a contactable physician. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 28Jan2021 16:00 (at the age of 47 years old) at a single dose for covid-19 immunization. Medical history included known allergies: shellfish, seasonal allergies and psoriasis. Concomitant medications included several medications in two weeks. The patient is not pregnant. The patient had no other vaccine in four weeks. On 29Jan2021 23:45, after being asleep for approximately one hour, felt acutely short of breath and anxious, which lasted less than a minute and was then followed by numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE). These events resulted in emergency room visit. The patient underwent lab tests and procedures which included PCR/nasal swab on 29Jan2021 (post vaccination) which showed negative. Therapeutic measures were taken as a result of all the events which included diphenhydramine (BENADRYL), IVF. Outcome of all the events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Psoriasis; Seasonal allergy; Shellfish allergy,,,"['Anxiety', 'Dyspnoea', 'Hypoaesthesia', 'Paraesthesia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1068052,,50.0,F,"right cervical and axillary lymphadenopathy; This is a spontaneous report received from a contactable nurse (who is also the patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiry date: unknown), via an unspecified route of administration on the right arm, on 27Jan2021 13:15, at single dose, for COVID-19 immunization, at public health department. Medical history included hypertension (HTN), anxiety, depression, myalgia and penicillin allergy (PCN allergy). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Concomitant medication included losartan; hydrochlorothiazide, triamterene (MAXZIDE); cetirizine; colecalciferol (VITAMIN D); escitalopram oxalate (LEXAPRO). The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccination. On 29Jan2021, the patient experienced right cervical and axillary lymphadenopathy. No treatment was given for the event. The patient was recovering from the event. The reporter assessed the event as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/29/2021,2.0,PUB,LOSARTAN; MAXZIDE; CETIRIZINE; VITAMIN D; LEXAPRO,,Medical History/Concurrent Conditions: Anxiety; Depression; Hypertension; Myalgia; Penicillin allergy,,,['Lymphadenopathy'],UNK,PFIZER\BIONTECH, 1068053,KY,33.0,F,"headache; nausea; low grade temp/fever; body aches; chills; This is a spontaneous report from a contactable nurse (also the patient). A 33-year-old (also the age at vaccination) female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL8982), via an unspecified route of administration at the left arm on 24Jan2021 at SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient had no allergies to medications, food, or other products. The patient first dose was given on 03Jan2021 02:00 PM at the left arm (lot: EL3246) for covid-19 immunization. The patient was vaccinated at a Public Health Department (also reported as Public Health Clinic/Administration facility). The patient is not pregnant. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included ethinylestradiol, norethisterone (VYFEMLA), collagen and unspecified multivitamin and anti-allergy (reported as received within 2 weeks of vaccination). It was reported that the patient experienced low grade temp, fever, body aches, chills on 25Jan2021 at 04:00 AM, then fever, headache, nausea on 26Jan2021 and also headache on 27Jan2021. No treatment was received for the adverse event. The outcome of the events was recovered in Jan2021. The case/ events were considered as non-serious",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/24/2021,01/25/2021,1.0,PUB,VYFEMLA; COLLAGEN,,,,,"['Body temperature', 'Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1068054,MD,40.0,F,"Severe joint and muscle pain/persistent moderate joint pain; Severe joint and muscle pain; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1283), intramuscular on 12Jan2021 08:30 at single dose (left arm) for COVID-19 immunization. The patient medical history was not reported. The patient had no chronic health conditions. The patient was not pregnant. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL), cetirizine hydrochloride (ZYRTEC), and ergocalciferol (VIT D). The patient previously took demerol and toradol and experienced allergies. The patient received first dose of bnt162b2 on 22Dec2020, 16:30 (left arm; lot EK5730) for COVID-19 immunization. On 12Jan2021, the patient experienced severe joint and muscle pain on first night of 2nd vaccine and joints most involved were both ankles, hips, and wrists and mostly resolved by 48 hours. Then, it returned on post-vaccine Day 5, on 17Jan2021, and had persistent moderate joint pain in both ankles, hips, and right wrist. patient had been taking Naproxen scheduled x10 days at regular dose with no improvement. Patient discussed it with her hospital's Chief of ID and started taking scheduled high dose Naproxen and requested referral to rheumatologist. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had no other vaccine in four weeks, no covid prior vaccination and was not covid tested post vaccination. Outcome of events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/12/2021,0.0,WRK,JUNEL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VIT D,,,,,"['Arthralgia', 'Myalgia']",2,PFIZER\BIONTECH,OT 1068055,TX,62.0,F,"minor injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El324? (as reported)), via an unspecified route of administration at the left arm on 08Jan2021 at 13:00 (01:00 PM) at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no medical history. The patient had no allergies to medications, food, or other products. Concomitant medication included levothyroxine sodium (UNITHROID) that was received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced minor injection site soreness on Jan2021. The event was reported as non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovered on Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/01/2021,,UNK,UNITHROID,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: other medical_history: None",,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1068056,OR,40.0,F,"chills; fatigue; migraine-like headaches; dizziness; nausea; migraine-like headache and fatigue severe enough to prevent normal activity; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), intramuscularly into the left arm on 28Jan2021 14:15 at a single dose for COVID-19 immunisation. Medical history included Polycystic ovarian syndrome (PCOS), depression, obesity and allergies to latex. Patient was not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), bupropion hydrochloride (WELLBUTRIN), colecalciferol (VITAMIN D) and cyanocobalamin (VITAMIN B12). The patient previously took tetracycline and experienced drug allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscularly into the right arm on 06Jan2021 03:15 PM at a single dose for COVID-19 immunisation. On 28Jan2021 20:00, patient experienced chills, fatigue, migraine-like headaches, dizziness, nausea and migraine-like headache and fatigue severe enough to prevent normal activity. The events were reported as non-serious. The patient did not receive any treatment for the events reported. Outcome of events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/28/2021,0.0,PVT,CYMBALTA; WELLBUTRIN; VITAMIN D; VITAMIN B12,,Medical History/Concurrent Conditions: Depression; Latex allergy; Obesity; Polycystic ovarian syndrome,,,"['Chills', 'Dizziness', 'Fatigue', 'Loss of personal independence in daily activities', 'Migraine', 'Nausea']",2,PFIZER\BIONTECH,OT 1068057,NY,48.0,F,"Hives; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262), via an unspecified route of administration on 28Jan2021 at a single dose on the right arm for COVID-19 immunization. Medical history included asthma and postpartum cardiomyopathy on unknown dates and unknown if ongoing. The patient had allergies to sulfa and penicillin. Prior to vaccination, the patient has not had COVID-19. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), carvedilol (manufacturer unknown), cefixime (FLEXERIL), losartan (manufacturer unknown) and montelukast sodium (SINGULAIR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took Cipro, Biaxin and Ampicillin and allergies. Since the vaccination, the patient has not been tested for COVID. The patient experienced hives on 30Jan2021. The patient did not receive any treatment for the event. The patient has not recovered from the event. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/30/2021,2.0,UNK,ALLEGRA; CARVEDILOL; FLEXERIL [CEFIXIME]; LOSARTAN; SINGULAIR,,Medical History/Concurrent Conditions: Asthma; Drug allergy; Penicillin allergy; Postpartum cardiomyopathy,,,['Urticaria'],1,PFIZER\BIONTECH, 1068058,OH,50.0,F,"Chills; body aches; head and neck pain; head and neck pain; sinusitis; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration in left arm on 29Jan2021 14:00 at a single dose for Covid-19 immunization. Medical history included asthma, and Covid-19 prior to vaccination. Patient was not pregnant. Concomitant medication included bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and had allergy. The patient experienced chills, body aches, head and neck pain, and sinusitis on 29Jan2021. No treatment was given. Patient has not tested for Covid after vaccination. Outcome of the events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,WRK,WELLBUTRIN,,Medical History/Concurrent Conditions: Asthma; COVID-19 (If covid prior vaccination: Yes),,,"['Chills', 'Headache', 'Neck pain', 'Pain', 'Sinusitis']",1,PFIZER\BIONTECH, 1068059,,,F,"I felt extremely achy all over especially in my arms hands neck and back/left arm aches all the way down; I had a headache; felt lightheaded at times/slight dizziness; experienced chills on and off; But I was very tired and it lasted for around 20 hours.; not feeling normal; This is a spontaneous report from a contactable consumer (patient herself). An elderly female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL9262), via an unspecified route of administration on the left arm, first dose on 28Jan2021 09:15 at single dose for COVID-19 vaccination. Medical history included pre - diabetic and have hypertension, known allergies Yeast and some perfumes Sulfa drugs. Patient is not pregnant. Patient did not have COVID prior to vaccination. Concomitant medication included metformin and losartan. On 28Jan2021, at 08:00 PM, patient felt extremely achy all over especially in her arms hands neck and back. She had a headache and felt lightheaded at times and experienced chills on and off. So she took ibuprofen for extremely achy all over especially in her arms hands neck and back. She had a headache and felt lightheaded at times and experienced chills on and off. But patient also stated that she was very tired and it lasted for around 20 hours. It has been 4 days since the shot and she was not feeling normal in that she have some lightheaded or slight dizziness and her left arm aches all the way down. Patient was not treated for the other events. Patient was not tested post vaccination. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,UNK,METFORMIN; LOSARTAN,,Medical History/Concurrent Conditions: Allergy to edible fungus (known allergies Yeast and some perfumes Sulfa drugs); Hypertension (I am pre - diabetic and have hypertension); Perfume sensitivity (known allergies Yeast and some perfumes Sulfa drugs); Pre-diabetic (I am pre - diabetic and have hypertension); Sulfonamide allergy (known allergies Yeast and some perfumes Sulfa drugs),,,"['Chills', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Headache', 'Pain']",1,PFIZER\BIONTECH, 1068060,,,F,"She had a severe vaginal reaction; This is a spontaneous report from a contactable pharmacist. A 51-years-old female patient (nurse) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration as a SINGLE DOSE for covid-19 vaccination. The patient medical history and concomitant medications were not reported. The patient experienced she had a severe vaginal reaction. The nurse informed the pharmacist that she had used a personal lubricant during intercourse. The pharmacist asked if a common ingredient in the personal lubricant and most cosmetic fillers, hyaluronic acid, could be the culprit for the reaction that was experienced by the nurse. When the patient originally reported the adverse event she did not have the details regarding the use of the lubricant. The clinical outcome of the event was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaginal disorder'],UNK,PFIZER\BIONTECH, 1068061,,,F,tested positive for covid before getting her second dose; tested positive for covid before getting her second dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at SINGLE DOSE for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient received the first dose of the Pfizer vaccine at her workplace. She tested positive for covid before getting her second dose and wanted to know how this will affect the administration. The outcome was unknown. Information on the Lot/Batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068062,,,M,"Arm pain or discomfort on the injection site; Arm pain or discomfort on the injection site; This is a spontaneous report from a Pfizer-sponsored Program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm pain or discomfort on the injection site. The patient reported it was not severe, he just wanted to know if he can take Tylenol or Advil. Outcome of the events was unknown. Information of lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Pain in extremity', 'Vaccination site discomfort']",1,PFIZER\BIONTECH, 1068063,AZ,78.0,F,"felt fairly decent/feel bad; she ""came down with covid""/test positive for COVID; she is kind of weak; her heart was racing; aching/aches; she ran a fever that got up to 101; cough; her arm got sore; allergies; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283) on 15Jan2021 at single dose in left arm for COVID Prevention. Medical history included ongoing High Blood Pressure, she was diagnosed approximately 5 years prior to starting blood pressure medications in 1998. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN AND HYDROCHLOROTHIAZIDE) at 320mg/12.5mg, once daily, by mouth from 1998 and ongoing, amlodipine besylate at 5mg, once daily, by mouth at night from 1998, both for High blood pressure. The patient stated that she did not realize, but she must have been exposed to the COVID Virus, prior to getting her shot. She stated that on 15Jan2021, she went and got her Pfizer COVID shot, and that same day, by the time she got home, she was starting to feel bad and it went downhill from there. She mentioned that on the same day on 15Jan2021, she ""came down with covid"". She finally went in on 22Jan2021, and got tested, and she did test positive for COVID. The patient was tested Positive for COVID-19 on 22Jan2021. She did believe she was getting better. On 29Jan2021, she felt fairly decent, and today, she is kind of weak but she is assuming that will happen. She was scheduled to go back for her second dose on 08Feb2021, and she is wondering if there are recommendations about the second dose, for people who tested positive for COVID after having gotten the first dose. When queried for her PCP contact information, she stated that her head is not working really great and she feels stupid she did not have this information handy to provide. She states that the first week with her symptoms, she just figured she did have the virus. She had a cough but it never got down to where she had trouble breathing, and she just figured that her body had to go through, whatever it was going to go through, and as long as the patient felt like she was okay, there was not anything anyone could do, she just had to play it out. When she did finally go get tested, the doctor told her to get on Nyquil and Ibuprofen, so that is what the patient has been taking, and she feels like it has helped a lot. Before she saw the doctor, she was taking Acetaminophen, but the doctor told her to do the Nyquil and Ibuprofen, so that is what she has been doing. By the time she got home from getting her vaccine, her heart was racing. She took her blood pressure and it was okay at 125/73, and her heart rate was 72. She has high blood pressure and she takes two medications for that, so she took her night time blood pressure pill and the fast beating of her heart went away. The next day, she got to aching. She has had all different aches, and she ran a fever that got up to 101, and the rest of the time it was 100 or 99, but the fevers were not all day long, they would just come and go. Now she has had no fever in four or more days, and she is doing better. She does still have the cough, but she also has allergies so she does not know what is causing the cough. As far as the reaction to the vaccine, just her arm got sore. But she thinks she was exposed prior to getting the vaccine and just did not know it. she stated that the people took her temperature the day of the shot and she didn't have a temperature. She did not receive any other vaccines on the same day as the COVID vaccine. The outcome of fever was recovering, of cough and allergies was not recovered, of her heart was racing was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/01/2021,,UNK,VALSARTAN AND HYDROCHLOROTHIAZIDE; AMLODIPINE BESYLATE,Blood pressure high (diagnosed approximately 5 years prior to starting blood pressure medications in 1998),,,,"['Asthenia', 'Blood pressure measurement', 'Body temperature', 'COVID-19', 'Cough', 'Feeling abnormal', 'Heart rate', 'Hypersensitivity', 'Pain', 'Pain in extremity', 'Palpitations', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068064,NY,66.0,M,"Chills; stabbing headache; low grade fever (100.4F); body aches; dry cough; fatigue; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection, Lot number: EN5318) via unspecified route of administration, on right arm, at 08:15 on 24Jan2021 at single dose for COVID-19 immunization. The patient medical history included childhood asthma, lymphomatoid papulosis, small fiber neuropathy, canker sores on tongue, allergies to penicillin, eggplant, quinoa. The concomitant medication was not reported. The patient previously took celecoxib (CELEBREX) and experienced allergies. The patient experienced chills followed by stabbing headache, low grade fever (100.4F), body aches, dry cough and fatigue at 21:00 on 29Jan2021. It was reported that symptoms lessened within 24 hours and after 48 hours only cough and fatigue remained. It was reported that as of 01Feb2021, the patient had only occasional cough and some fatigue. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient had not received any treatment for the events. The events were reported as non-serious. The patient had not diagnosed with COVID-19 prior to vaccination and had not been rested for COVID-19 since the vaccination. The outcome of the events chills, stabbing headache, low grade fever (100.4F), body aches was recovering, while for fatigue and dry cough was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/29/2021,5.0,UNK,,,"Medical History/Concurrent Conditions: Canker sores oral (Canker sores on tongue); Childhood asthma; Food allergy (allergies: eggplant, quinoa); Lymphomatoid papulosis; Penicillin allergy; Small fiber neuropathy",,,"['Body temperature', 'Chills', 'Cough', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 1068065,CA,,F,"9 days after first dose had a PCR test for Covid-19 and she received her positive results; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect via a contactable consumer. A 93-year-old female patient (consumer's mother) received the first dose of bnt162b2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. 9 days after first dose the patient had a PCR test for covid-19 and she received her positive results in Jan2021. The outcome of the event was unknown. Information about Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068066,,,F,"Caller stated she tested positive for covid the night of the first dose of the vaccine; This is a spontaneous report from a contactable nurse. This (Age: 25; Unit: Unknown) female Nurse (patient) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The patient tested positive for COVID the night of the first dose of the vaccine. The outcome of the event was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068067,MN,,F,tested positive for Covid; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (daughter) received 1st dose of BNT162B2 on 15Jan2021 at singe dose for Covid-19 Immunisation. Medical history and concomitant drug were not reported. She got her first dose of the vaccine on 15Jan2021 and then tested positive for COVID on the 24Jan2021. She is wondering how long daughter has to wait to receive her 2nd dose of the COVID vaccine. Outcome of the events was unknown. Information on Lot/Batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/24/2021,9.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068068,,34.0,F,"tested positive for Covid/positive results for COVID/she felt symptoms; This is a spontaneous report from a contactable consumer. This 34-year-old female consumer (patient) reported that she received the first dose of bnt162b2 (BNT162B2, Batch/lot number: EL1283) , via an unspecified route of administration at left arm on 14Jan2021 at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced tested positive for covid/positive results for covid on 16Jan2021 with outcome of unknown. Consumer states that she might have had COVID prior to getting her first dose and just did not know it, because after the first dose she felt symptoms and got positive results for COVID on 16Jan2021. She stated that she was on day 16 of quarantine, and she had her last COVID results four or 5 days ago (Jan2021), and it was positive. She stated that she got her last test on Saturday (30Jan2021), but did not have the results yet. She had no other vaccines on the same day as the COVID vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/16/2021,2.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068069,,45.0,F,"had mild symptoms chills; body ache; This is a spontaneous report from a contactable nurse (patient). This 45-year-old patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route on 29Jan2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included COVID-19 in April2020 and a positive COVID-19 test on 28Jan2021. Concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced mild symptoms, chills and body aches. On Saturday (30Jan2021) the patient didn't go to work. The patient was concerned because she found out after receiving the vaccine that she had COVID-19 when she received the vaccine. She wanted to know if there were any issues regarding her health with being positive and having gotten the vaccine. The outcome of mild symptoms, chills, and body aches was recovered on Sunday (31Jan2021). The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: COVID-19 (I also had covid in April),,,"['Chills', 'Pain', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1068070,FL,,M,"His father got his first covid vaccine shot in (place) and 5 days after he was tested positive with covid 19 but did not get any symptoms.; This is a spontaneous report from a non-contactable consumer. This consumer reported on behalf of his father. A male patient of an unspecified age received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got his first COVID vaccine shot in and 5 days after he was tested positive with COVID 19 but did not get any symptoms. Asking if his father could get the second COVID vaccine shot. Outcome of the event was unknown. No follow-up attempts are possible, Information about batch/lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1068071,,79.0,M,"feeling lousy; chills; low grade fever 101.9; everything hurt, muscles, head; everything hurt, muscles, head; everything hurt, muscles, head; real tired; weak; a lot of the same symptoms from the COVID virus, he can relate to COVID because he had had the COVID and for 2 weeks he was like that; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for two patients. This is the first of two reports, reporting for self. This 79-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 29Jan2021 at 9 AM at single dose for COVID-19 immunisation. The patient's medical history included COVID virus in Aug2020. The patient's concomitant medications were not reported. The patient received the first dose of vaccine on 29Jan2021 at 9 AM and got a reaction around 9 PM. The patient stated a lot of the same symptoms from the COVID virus came back after the vaccine. The first thing was chills, patient took a couple of paracetamol (TYLENOL), and they went away after about a half hour. The patient had a low grade fever 101.9 at 29Jan2021 night to 30Jan2021, and took paracetamol then as well. The patient reported the biggest thing was everything hurt including muscles and head. Patient felt weak, more or less tired with no energy following the vaccination. The symptoms were from 29Jan2021 night until probably 31Jan2021 morning noon, then he started to feel little bit better. The patient hardly miss work, but missed work on 30Jan2021. The patient stated feeling pretty good and pretty much back to normal on 01Feb2021, it did not affect breathing or cough, just fever and feeling lousy. The patient commented that he can relate to COVID because he had had the COVID and for 2 weeks he was like that. He also had the breathing problem with the virus in Aug2020, and he think he had every symptom but did not lose taste or smell. The patient asked if he should take his second dose of vaccine. The outcome of event chills was resolved on 29Jan2021. The outcome of event fever was resolved on 30Jan2021. The outcome of other events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148753 same reporter/drug/events, different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,UNK,,,"Medical History/Concurrent Conditions: COVID-19 (I was laid up for about a month, before he was negative)",,,"['Asthenia', 'Body temperature', 'Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Myalgia', 'Pain', 'Pyrexia', 'Suspected COVID-19']",1,PFIZER\BIONTECH, 1068072,NV,49.0,F,"sick; tested positive for Covid after first dose of vaccine; This is a spontaneous report from a contactable Nurse. This 49-year-old female nurse reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EJ1685) on 21Dec2020 at left arm for Covid vaccine. Medical history included hypertension diagnosed 20 years ago and asthma diagnosed all her life. Concomitant products were not provided. She was scheduled to get the second dose but she tested positive for COVID on 28Dec2020. She got sick with the first dose so she was scared about getting the second dose. She was still positive for Covid as of 21Jan2021 and still symptomatic with a cough, no smell or taste. She did not know when she can get the second vaccine. The outcome of Covid was not resolved, of other event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/21/2020,12/28/2020,7.0,UNK,,,Medical History/Concurrent Conditions: Asthma (diagnosed all her life); Hypertension (diagnosed 20 years ago),,,"['COVID-19', 'Illness', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068073,,,M,"my fever has been worst than it's been; This is a spontaneous report from a contactable consumer reported for himself. This 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient received the first dose of the Pfizer vaccine. He wanted to know when he would have normalcy. He stated it had been going on for 9 days and it's not getting better. Today had been worse, his fever had been worst than it's been. When he showed up for his second dose because he had a high fever the night before, they pushed it back, 7 days from when he was supposed to receive the 2nd shot. It (fever) didn't start until his 3rd week. The outcome of event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pyrexia'],1,PFIZER\BIONTECH, 1068074,CA,26.0,F,"Soreness and swelling at injection site (right arm); Soreness and swelling at injection site (right arm); Fatigue; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient). This 26-year-old non-pregnant female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via unspecified route of administration in the right arm on 27Jan2021 at 11:00 (at the age of 26-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not have COVID-19 prior to vaccination, and did not receive any other vaccines in the 4 weeks prior to vaccination. Concomitant medications included paracetamol (TYLENOL) from an unknown date for an unknown indication; ibuprofen (ADVIL) from an unknown date for an unknown indication; and ethinylestradiol, etonogestrel (NUVARING) from an unknown date for an unknown indication. On 27Jan2021 at 21:00 the patient experienced soreness and swelling at injection site (right arm), fatigue, nausea, and headache, all lasting 24 hours after inoculation. No treatment was received for the events. The clinical outcomes of soreness and swelling at injection site (right arm), fatigue, nausea, headache, were recovered on 28Jan2021 at 21:00. It was also reported the patient did not test for COVID-19 post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,WRK,TYLENOL; ADVIL [IBUPROFEN]; NUVARING,,,,,"['Fatigue', 'Headache', 'Nausea', 'Vaccination site pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 1068075,,47.0,F,"Her upper lip is a little swollen; Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 31Jan2021 at 08:43 (at the age of 47-years-old) at single dose for COVID-19 vaccination. Medical history included seafood allergy (also happens when she gets seafood from, company name, it makes her lips puffy). Concomitant medications were not reported. The patient stated everything was fine except for some injection site soreness on 31Jan2021 that lasted about two hours then completely resolved. On 01Feb2021, the patient stated this morning her upper lip is a little swollen (puffy). The puffiness as if a 2 year were to head butt you and it left your lip puffy. The patient stated last night for dinner she ate ham which was a different brand than usual and was wondering if it may have had some preservatives in it that could have caused the lip swelling and did not have any lip swelling before she went to bed at 10 pm last night. The outcome of the event lip swelling was unknown. The outcome of the event injection site soreness was recovered on 31Jan2021 after 2 hours. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/31/2021,01/31/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Seafood allergy (also happens when she gets seafood from (company name) it makes her lips puffy),,,"['Lip swelling', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 1068076,,,F,"neurological adverse event; This is a spontaneous report from a non-contactable physician (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the COVID vaccine on an unspecified date and had neurological adverse event to it on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Nervous system disorder'],UNK,PFIZER\BIONTECH, 1068077,CO,78.0,F,"Headache; pains in knee and muscle above knee; pains in knee and muscle above knee; Fever; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EN5318 expiration date: 31Jan2021, via an unspecified route of administration on 31Jan2021 12:20 at a single dose in the right arm for COVID-19 immunization. The patient had no family medical history and no concomitant medications. The patient had her first dose yesterday (31Jan2021), and she had some reactions to it last night 31Jan2021, had fever, headache and pains in knee and muscle above knee. She knows some of the side effect was normal. She was wondering more so, when is it ok to take a pain reliever for it, like aspirin or Ibuprofen. She went online and it said not to take anything, so she did not. She imagined her fever went away sometime during the night, she took it (unspecified) twice last night. This morning when she woke up, she had the headache, and it's gone now. Her pain in the knee started 4 hours after the injection, it was still sore but much better. The events did not require a visit to the emergency room. The patient had no prior vaccinations within four weeks. The outcome of the event fever was recovered on 31Jan2021, headache recovered on 01Feb2021 and for events pains in knee and muscle above knee was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,01/31/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH, 1068078,WV,86.0,F,"felt like she had the flu; muscle to her left arm is sore; stated that left arm below the shot is red with splatters going down to elbow; neck was hurting left side radiating to shoulders; stated when she takes breath in hurts under arms down to ribs on left side; she has arthritis and stated both knees hurt and stiff; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL9261) solution for injection, via an unspecified route of administration in left arm on 29Jan2021 at a single dose for Covid-19 immunization. Medical history included arthritis. Concomitant medications included paracetamol (TYLENOL) and other medications. The patient reported she had the second shot on 29Jan2021 and the muscle to her left arm was sore on 30Jan2021(for clarification). On 30Jan2021, she felt like she had the flu, stated that her left arm below the shot was red with splatters going down to elbow, neck was hurting left side radiating to shoulders and stated when she takes breath in it hurts under arms down to ribs on left side. She also mentioned she has arthritis and stated both knees hurt and stiff on 30Jan2021. Treatment: patient stated that she rubbed her knees with Bengay on Saturday. Patient stated that all these are for second shot. She did not have any problems with the first shot which she had on 07Jan2021. She stated that she will let her doctor know when she sees him. Outcome of the event felt like she had the flu was recovered on 31Jan2021; she has arthritis and stated both knees hurt and stiff was recovered on 30Jan2021; left arm below the shot is red with splatters going down to elbow was recovering; while the rest of the events was not recovered. No follow-up activities are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,UNK,TYLENOL,,Medical History/Concurrent Conditions: Arthritis,,,"['Arthritis', 'Influenza like illness', 'Musculoskeletal chest pain', 'Neck pain', 'Vaccination site erythema', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1068079,NY,66.0,F,"migraine with flashes of light in left eye; migraine with flashes of light in left eye; gets IBS stuff; has had diarrhea; diarrhea, had a mild version of the diarrhea that seemed to get worse after the vaccine and still ongoing; vessels in hands really dilated and dark blue; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL9264), via an unspecified route of administration (arm left) on 30Jan2021 14:00 at SINGLE DOSE for to have some protection against COVID, at 66 years old. Medical history included connective tissue disorder and anti-cardiac lipid antibody problem; she is prone to blood clots from 2001. At that time, she was sent to the hospital and no one could figure out what it was. She was seeing the Rheumatologist and another person, and they knew something was going on and was given Prednisone (from 2001) because her tissues in the joints were swelling and she had trouble with speech. Patient also reported this as some weird connective tissue disorders already and some anti-cardiac lipid antibody problem. It was really weird and had not changed a bit since so she was kind of checking to see if anyone has reported anything like this. She reported that with this weird antibody problem, she is more prone to blood clots and has to be careful with medications with her blood she knows that some breast cancer medicines can do that. She stated this immune thing was never diagnosed. She also had migraine with globes of flashes of light, left eye (does not typically get migraines and has only had 1 in her life and she saw globes of lights in both eyes and had to go to the emergency room and was told it was an ocular migraine and this was also only in the left eye. This was long ago) from an unspecified date. Concomitant medication included low dose steroid (unspecified). The patient previously received flu vaccine on Sep2020 (AE none). No other vaccines were administered on the same day. On 30Jan2021, the patient experienced vessels in hands were really dilated and dark blue 5 hours after vaccination. On 30Jan2021, the patient also experienced IBS stuff and has had diarrhea the last couple of days after getting the COVID vaccine. She took Pepto Bismol to help and had a mild version of the diarrhea that seemed to get worse after the vaccine and still ongoing. On 01Feb2021, the patient experienced migraine with flashes of light in left eye. It was further described as having a weird migraine with flashes of light in the left eye and she got the shot in her left arm and not sure if that makes any difference. She does not typically get migraines and has only had 1 in her life. The migraines started in the morning and lasted about an hour (as reported) and now they are gone and hopes they stay gone (reported as recovering). She wanted to know if she can take TYLENOL or ibuprofen for vaccine. She heard about people getting symptoms after the second dose not the first dose. Events did not require visits to the emergency room or physician office, but stated that if her vision become worse, she would go to the eye infirmary close by. The outcome of the events diarrhea and vessels in hands really dilated and dark blue, gets IBS stuff was not recovered. Outcome of the events migraine with flashes of light in left eye was reported as recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Clotting disorder; Connective tissue disorder (her tissues in the joints were swelling and she had trouble with speech); Flashing lights; Migraine; Speech disorder (her tissues in the joints were swelling and she had trouble with speech),,,"['Diarrhoea', 'Irritable bowel syndrome', 'Migraine', 'Photopsia', 'Vein disorder']",1,PFIZER\BIONTECH, 1068080,IL,65.0,F,"She is having a hot flash; she gets warm; left arm started hurting really bad, it was throbbing; Headache; Tiredness; Sleepy like/She had the sleepiness last night; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not available), on the left arm, intramuscularly, on 30Jan2021 at 14:30 at single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. No vaccine administered on the same day as BNT162B2 and no other vaccines administered within 4 weeks prior to administration. On 30Jan2021, it was reported that after the patient got the shot she felt the tiredness, sleepy-like. She had the sleepiness last night, she slept really good. The patient added that she had the first dose and she was fine. Then at night on 31Jan2021 around 1am or 130am her left arm started hurting really bad, it was throbbing. She could not put her hand over her arm, it was so painful. She called her work and was told to put ice on it and take ibuprofen. Patient also experienced headache on 31Jan2021 and took Tylenol which took away the headache, however, the patient reports headache at the time of reporting. Patient reports that on an unspecified date, she is having a hot flash, states she gets warm and then it goes away. The patient did not visit an emergency room but will see her doctor to report what is going on with her. Patient reports she is not going to take the second dose. She took off work Sunday since it was so bad and could not work like that. She is asking what happens if she does not take the second dose and how long does it take for the first dose to wear off. The outcome of the events tiredness and sleepy-like was unknown, for the event headache was not recovered, for the event left arm started hurting really bad, it was throbbing was recovering, while for the events having a hot flash, states she gets warm was recovered. The patient was vaccinated at an assisted living facility for 65+ and not in a military facility. Information regarding batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,SEN,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Fatigue', 'Feeling hot', 'Headache', 'Hot flush', 'Pain in extremity', 'Somnolence']",1,PFIZER\BIONTECH,OT 1068081,NY,75.0,F,"Extreme tiredness; nausea; feeling like I was run over by a truck; chills; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received first dose BNT162B2 (Solution for injection, Lot number: EL9264) via an unspecified route of administration on 31Jan2021 16:00 at single dose in right arm for covid-19 immunisation. Medical history included breast cancer and hodgkin Lymphoma. Concomitant medication included simvastatin, vitamin d nos. The patient had extreme tiredness, nausea, feeling like I was run over by a truck, chills, headache, weakness on 01Feb2021 at 13:00 pm. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse event. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,02/01/2021,1.0,PVT,SIMVASTATIN; VITAMIN D NOS,,Medical History/Concurrent Conditions: Breast cancer female; Hodgkin's lymphoma,,,"['Asthenia', 'Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Nausea']",1,PFIZER\BIONTECH, 1068082,AR,26.0,F,"vertigo; light headedness; nausea; This is a spontaneous report received from a contactable other health professional (patient herself). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on left arm on 19Jan2021 12:15 at single dose for COVID-19 immunisation at hospital. Medical history included depression and anxiety. The patient had no allergies to medications, food, or other products. Concomitant medication included trazodone at 100 mg and sertraline at 150 mg; both are received within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, two weeks after vaccine (on 01Feb2021 22:00) the patient had onset of vertigo, light headedness, and nausea. Patient still experiencing vertigo 12 hours later. Did not imbibe alcohol or substances. Did not do strenuous activity. The adverse events result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events were assessed as non-serious by the reporter. The outcome of the events was reported as recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,02/01/2021,13.0,PVT,TRAZODONE; SERTRALINE,,Medical History/Concurrent Conditions: Anxiety; Depression,,,"['Dizziness', 'Nausea', 'Vertigo']",1,PFIZER\BIONTECH, 1068083,,,F,"soreness in the arm; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a very tiny soreness in the arm in Jan2021 and its already gone. The patient recovered from the event in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/01/2021,,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1068084,WI,54.0,F,"her tongue swelled/started to have tongue swelling; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 54-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1203, expiration date: unknown), via an unspecified route of administration from 26Jan2021 to 26Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient has no medical history. Concomitant medications were not reported. On 26Jan2021, after the administration of the vaccine her tongue swelled and started to have tongue swelling. Therapeutic measures were taken as a result of her tongue swelled/started to have tongue swelling which included Benadryl. The outcome of the event was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Swollen tongue'],1,PFIZER\BIONTECH, 1068085,NY,,F,"arm is a little sore; headache; sinus; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot and expiry were not reported), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her 1st dose last Friday and no reactions but arm was a little sore. The patient asked if she could take over the counter drug for headache and sinus. The patient said that it was normal for her to experience these. The patient also asked if she could take some over the counter drugs and how many days not to take any over the counter drug. The patient further asked if she could take acetylsalicylic acid (ASPIRIN) or pseudoephedrine hydrochloride (SUDAFED) for her normal headache and sinus. The patient said that it was not the side effect from the Covid-19 Vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported headache, sinus, and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,,,UNK,,,,,,"['Headache', 'Pain in extremity', 'Sinus disorder']",1,PFIZER\BIONTECH, 1068086,MA,,F,"Incorrectly administered to the Bursa (arm fluid sac); Injury; This is a spontaneous report from a contactable nurse (nurse practitioner reporting for herself, also reported as ""Nurse with 4 degrees"") via a Pfizer-sponsored program Pfizer First Connect. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot# and Expiration Date were unknown), via an unspecified route of administration (reported as ""administered to the Bursa (arm fluid sac)"") on 09Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose last 09Jan2021 but was incorrectly administered to the Bursa (arm fluid sac) of her shoulder. The patient would like to check the efficacy of the 1st dose. Patient would also like to know if she needs to take a 3rd dose due to what happened. The patient stated that she was a Nurse Practitioner so she wanted to know if she needs to get revaccinated again because it was vaccinated inappropriately and maybe what the efficacy is, if they have any information on that, if it was administered there. The patient also stated ""So, why did they connect me to this department, was it because of the injury that was sustained (not clarified), because of it? Is it because of the injury that I got from it? Why did they sent me to you, specifically why your department, was I spent to the department originally, why the previous person, why did the person I spoke to before you forward me to you. I think I am just so frustrated because to our way being told that you would be able to like answer the questions or solve the issues and then finding out that wasn't the case. I think I am just frustrated because I was told that you are the correct department to help me and that I was told to wait for two hours"". Outcome of the event injury was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/01/2021,,UNK,,,,,,"['Incorrect route of product administration', 'Injury']",1,PFIZER\BIONTECH, 1068087,TX,,M,"Tested positive 5 days after his first dose; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 17Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, 5 days after his first dose, the patient tested positive (SARS-CoV-2 PCR test positive). The outcome of event was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/17/2021,01/01/2021,,UNK,,,,,,"['SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1068088,NY,,M,"just a shoulder pain; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (31Jan2021), this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history included back pain. The patient's concomitant medication included tramadol for back pain and unspecified Blood thinner. It was reported that patient already took the vaccine and was taking Blood thinner and tramadol for his back pain, wanted to know if that was okay. The patient wanted to know if the vaccine was contraindicated to be administered with people taking blood thinners and tramadol. The patient stated that he had no other side effects but just a shoulder pain around the injection site. The said it was normal for him and will go away with time. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,TRAMADOL,,Medical History/Concurrent Conditions: Back pain,,,['Arthralgia'],UNK,PFIZER\BIONTECH, 1068089,SC,,F,"All of the other symptoms that I had when I had COVID returned for about four days; All of the other symptoms that I had when I had COVID returned for about four days; I had a high fever; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 31Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable Nurse (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date was not reported), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included COVID and a COVID infection which the patient recovered maybe for two weeks when she received the first dose of the vaccine. The patient's concomitant medications were not reported. The patient mentioned that she had fever for four days after receiving vaccine, and had covid and received 1st dose of vaccine only a few weeks later, wanted to know if she should receive the 2nd dose of the vaccine. The patient received first dose of the vaccine and mentioned that she was reluctant to receive the second dose based on the reaction that she had. She mentioned that she had recovered from COVID and a COVID infection. She recovered maybe for two weeks when she received the first dose of the vaccine. She mean, then she had a high fever, all of the other symptoms that she had when she had COVID returned for about four days. The high fever was what concerned her because it wasn't that high when she was ill. So, she wasn't sure whether it was advisable to get the second dose and if she should, she queried, how long should she wait before she get it. The onset dates for the events was unknown. The outcome of ""All of the other symptoms that I had when I had COVID returned for about four days"" and 'I had a high fever' was recovered on an unknown date (duration of 4 days).; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,,,UNK,,,Medical History/Concurrent Conditions: COVID-19 (recovered maybe for two weeks when she received the first dose of the vaccine),,,"['Drug ineffective', 'Pyrexia', 'Suspected COVID-19']",1,PFIZER\BIONTECH, 1068090,CA,,M,"he started feeling weak and chills; he started feeling weak and chills; This is a spontaneous report from a Pfizer-sponsored Program. A contactable consumer reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiration date unknown) via an unspecified route of administration on 30Jan2021 at a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that her husband got his first COVID-19 vaccine yesterday and now, 31Jan2021, he started feeling weak and chills. Outcome of the events was unknown. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,01/31/2021,1.0,UNK,,,,,,"['Asthenia', 'Chills']",1,PFIZER\BIONTECH, 1068091,,,F,"Skin rashes after the 1st vaccine; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced skin rashes after the first dose of the vaccine on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Rash'],1,PFIZER\BIONTECH, 1068092,,,F,"swollen tongue after the 1st vaccine; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swollen tongue after the 1st vaccine. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Swollen tongue'],1,PFIZER\BIONTECH, 1068093,,,F,"After receiving her 1st dose of vaccine she got Covid virus; After receiving her 1st dose of vaccine she got Covid virus; This is a spontaneous report from a Pfizer sponsored program from a contactable female consumer (patient). er First A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After receiving 1st dose of vaccine, the patient got Covid virus now, she wanted to know if she still needed to take the 2nd dose of vaccine. The outcome of events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1068094,FL,,F,"wife tested positive; wife tested positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter and his wife received the first dose 3 weeks ago (Jan2021) and the 2nd dose is scheduled tomorrow, 01Feb2021. He said they were 3 in the house and there was an adult handicapped child living with them. His wife and child both took the swab test last weekend (Jan2021). His child tested negative, but his wife tested positive. He was asking if his wife tested positive after the 1st dose and if they can continue the 2nd dose tomorrow. Outcome of the events was unknown. Information on about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068095,,,F,"experienced chills after the 2nd shot; This is a spontaneous report from a contactable consumer. A female patient (wife) of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient experienced chills (Jan2021) after the 2nd shot yesterday on 30Jan2021. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,01/01/2021,,UNK,,,,,,['Chills'],2,PFIZER\BIONTECH, 1068096,,,F,"Headache; she really isn't feeling well; BP has been going up; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the 2nd dose on 28Jan2021 and woke up with a headache since and BP has been going up on an unspecified date in 2021. They tried transferring the patient, but the patient reported she really wasn't feeling well and didn't want to wait long so they tried disconnecting due to long hold times and transfer the patient but accidently disconnected on the patient. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,,,UNK,,,,,,"['Blood pressure increased', 'Blood pressure measurement', 'Headache', 'Malaise']",2,PFIZER\BIONTECH, 1068097,FL,,U,"pain at the site of injection for 2 days duration; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. After receiving second vaccination, the patient experienced pain at the site of injection for 2 days duration. No other symptoms. Event took place after use of product. The outcome of the event was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination site pain'],2,PFIZER\BIONTECH, 1068098,TX,,F,"she reports chills; feeling achy all over; cannot sleep; exhausted; slight temperature to 99.9; splotchy rash on her trunk; This is a spontaneous report from a contactable pharmacist. A 19-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date. On an unspecified date, reported as after the second dose, the patient experienced chills, feeling achy all over, cannot sleep, exhausted, slight temperature to 99.9, and splotchy rash on her trunk. Outcome of the events was unknown. No follow-up attempts are possible, information about the lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Body temperature', 'Body temperature increased', 'Chills', 'Fatigue', 'Insomnia', 'Pain', 'Rash']",2,PFIZER\BIONTECH, 1068099,,74.0,M,"pain in the arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient (approximately 170 pounds, 5'11) received bnt162b2 (BNT162B2, lot/batch number and expiry date were not reported), via an unspecified route of administration in arm on 28Jan2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 28Jan2021, the patient experienced pain in the arm where he received the injection. The outcome of event was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/28/2021,0.0,UNK,,,,,,"['Pain in extremity', 'Weight']",UNK,PFIZER\BIONTECH, 1068100,SC,,U,"I have been diagnosed COVID Positive as of 29Jan2021; I have been diagnosed COVID Positive as of 29Jan2021; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose and the first dose, via an unspecified route of administration on an unspecified date at single dose for vaccination for COVID-19. The patient medical history and medications were not reported. It was reported that the patient was a Registered Nurse in the state of (state name withheld) and had received both doses of the Pfizer vaccination for COVID-19. The patient received second dose was 3 weeks before 01Feb2021 (in Jan2021) and the patient had been diagnosed COVID Positive as of 29Jan2021. The patient was not sure if we are keeping this type of data or not, but she/he believe it is useful for her/him to reach out and make this known. The patient had no fear that she/he would contract the virus after receiving his/her vaccination but she/he find herself/himself to be a part of the 5%. The outcome of the events was unknown. Information on batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/29/2021,,OTH,,,,,,"['COVID-19', 'SARS-CoV-2 test', 'Vaccination failure']",1,PFIZER\BIONTECH, 1068101,,,U,"On Friday, the patient showed symptoms of Covid. (name) felt exposure from a student; This is a spontaneous report from a non-contactable consumer via Pfizer sales representative. This consumer reported similar events for two patients. This is 1st of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. The concomitant medications were not reported. The patient was vaccinated with Pfizer Covid 19 vaccine on Tuesday 26Jan2021 and had no reaction. On Friday 29Jan2021, the patient showed symptoms of Covid. ""(name)"" felt exposure from a student. On Saturday night 30Jan2021, patient was administered with immunotherapy due to their comorbid medical conditions. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number could not be requested. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112464 same reporter, event/different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/29/2021,3.0,UNK,,,,,,['Exposure to SARS-CoV-2'],UNK,PFIZER\BIONTECH, 1068102,,,U,"patient showed symptoms of Covid/ felt exposure from a student; patient showed symptoms of Covid/ felt exposure from a student; This is a spontaneous report from a non-contactable consumer via a sales representative. This consumer reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date, via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. The patient's medical history were unspecified. The patient's concomitant medications was not reported. The patient was vaccinated on Tuesday 26Jan2021 with no reaction. On Friday (29Jan2021), the patient showed symptoms of Covid. Patient felt exposure from a student. On Saturday night, the patient was administered with immunotherapy due to comorbid medical conditions. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112463 same reporter, product, events, different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/29/2021,3.0,UNK,,,,,,"['Exposure to SARS-CoV-2', 'Suspected COVID-19']",1,PFIZER\BIONTECH, 1068103,LA,,M,"flu-like symptom; aches; chills; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that he felt like he had flu-like symptoms, aches and chills on an unspecified date (Event took place after use of product). The outcome of the event was unknown. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Chills', 'Influenza like illness', 'Pain']",UNK,PFIZER\BIONTECH, 1068104,LA,,F,"Arm pain; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced arm pain with first injection. The outcome of the event is unknown No follow-up attempts are possible;Information about Lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1068105,LA,,F,"Arm pain; Fatigue; Body aches; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration second dose on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization first dose from unknown date and experienced arm pain. It was reported that patient experienced on second dose of injection of arm pain. Additionally, the patient experienced body aches and fatigue but able to work with Tylenol. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Fatigue', 'Pain', 'Pain in extremity']",2,PFIZER\BIONTECH, 1068106,,,U,"little bit of upper respiratory symptoms; feel like I've been hit by a truck; headache; sinus pressure; vomiting; fatigue; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history of patient's body attacking itself during immune responses.The patient's concomitant medications were not reported. On an unspecified date, the patient experienced a little bit of upper respiratory symptoms yesterday. She felt like she had been hit by a truck, had headache, sinus pressure, vomiting and fatigue. The outcome of the event was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Autoimmune disorder,,,"['Fatigue', 'Feeling abnormal', 'Headache', 'Paranasal sinus discomfort', 'Respiratory symptom', 'Vomiting']",UNK,PFIZER\BIONTECH, 1068107,,,F,"Arm was sore after receiving the vaccine; has been experiencing itchiness and redness at injection site; has been experiencing itchiness and redness at injection site; This is a spontaneous report from a Pfizer Sponsored Program, received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm was sore after receiving the vaccine and has been experiencing itchiness and redness at injection site has been putting cream on it to try and subside the reaction wanted to know if these are normal reactions. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Pain in extremity', 'Vaccination site erythema', 'Vaccination site pruritus']",1,PFIZER\BIONTECH, 1068108,MN,,M,"to get a rash that weekend.; This is a spontaneous report from a Pfizer-sponsored program. A consumer (patient) reported for a male patient of an unspecified age received the first dose of bnt162b2 (BNT162B2, lot/batch number and expiry date were not reported), via an unspecified route of administration on 21Jan2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a rash that weekend (Jan2021). The outcome of event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/01/2021,,UNK,,,,,,['Rash'],1,PFIZER\BIONTECH, 1068109,AZ,,M,"got tested positive; got tested positive; This is a spontaneous report from a Pfizer Sponsored Program . A contactable consumer reported for himself that a male patient with unknown age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient received the first dose of the Pfizer shot and he got tested positive and had symptoms (but the caller did not provide the specific symptoms). He is scheduled to get the second dose on 16Feb2021. Patient wanted to know if he can take the second dose on the scheduled one or he should delay it. The outcome of event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Drug ineffective', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1068110,MT,,M,He was released from his job on 01Jan2021 and was supposed to get the second COVID vaccination on 06Jan2021 but he did not and never got his second shot; tested positive for COVID/Got covid Jan 9th to 23rd; tested positive for COVID/Got covid Jan 9th to 23rd; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. He was released from his job on 01Jan2021 and was supposed to get the second COVID vaccination on 06Jan2021 but he did not and never got his second shot. He then tested positive for COVID on 18Jan2021. It was reported that the patient got COVID from 09Jan2021 to 23Jan2021. The outcome of events was unknown. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/09/2021,17.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'Inappropriate schedule of product administration', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068111,,,F,"Really bad headache; Fever; Nausea; Upset stomach; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect, received from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 25Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her second dose of vaccine on 25Jan2021 and that night she experienced really bad headache, fever, nausea, and upset stomach on 25Jan2021. She was still having these symptoms and wanted to know if this was normal. Outcome of the events was not recovered. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,UNK,,,,,,"['Abdominal discomfort', 'Headache', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH, 1068112,MO,64.0,F,"12Jan was the first dose of the covid vaccine, 18Jan she had a positive covid test; Congestion; Cough; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. A 64-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her right arm, via an unspecified route of administration on 12Jan2021 08:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient started to feel symptoms on 16Jan2021 09:00, which is cough and congestion. On 18Jan2021, she tested positive for COVID. She is scheduled for getting her second dose on 09Feb2021. She is calling to question if she should get the second dose since she was diagnosed with COVID. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/16/2021,4.0,PVT,,,,,,"['Cough', 'Nasal congestion', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1068113,NH,64.0,M,"he has cold like symptoms; Stuffed up nose; doesn't feel really good; pain in the site area; slept a lot and was tired; slept a lot and was tired; his stomach is nauseous and queasy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration in Jan2021 (also reported as ""around 19Jan2021"" or ""19Jan2021 or 20Jan2021"", pending clarification) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got his first COVID dose around 19Jan2021 (also reported as ""19Jan2021 or 20Jan2021"") and now he has cold like symptoms. Stuffed up nose, doesn't feel really good and wanted to know if this part of the COVID vaccine. On the first day, he had pain in the site area, slept a lot and was tired. It has been 10 days since the shot and he had symptoms of a cold and his stomach was nauseous and queasy (also reported as squeezy). The reporter wanted to know if this was a part of the side effects or does she need to call his primary care. She was told about symptoms to watch for within the first seven days and this was well beyond the seven days. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['Fatigue', 'Hypersomnia', 'Malaise', 'Nasal congestion', 'Nasopharyngitis', 'Nausea', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1068114,FL,,F,"Caller tested positive for covid-19; Caller tested positive for covid-19; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A contactable consumer (patient) reported that female patient of an unspecified age received first dose of BNT162B2 (Lot number and expiry date not provided), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had first dose of the covid-19 vaccine on 17Dec2020 and she was tested positive for COVID-19 on 07Jan2021. She has not had her second dose, stated that MD said to wait 3 months because of antibodies, she would like information on what she should do. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Jan2021. The outcome of the events was unknown. Information on the Lot/Batch Number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/17/2020,01/07/2021,21.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068115,,,F,"Allergic reaction; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced an allergic reaction. On an unspecified date, the patient was hospitalized due to an unknown reason. The patient was inquiring if the company can help with hospital bills. Outcome of the event allergic reaction was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Hypersensitivity'],1,PFIZER\BIONTECH, 1068116,MI,,M,"He slipped and fell on the ice; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 27Jan2021 at a single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Since receiving the vaccine, the patient slipped and fell on the ice on an unspecified date and was wondering if he can take Tylenol for the pain during the vaccination series. The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,,,UNK,,,,,,['Fall'],1,PFIZER\BIONTECH, 1068117,,,F,"cold sore; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 31Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced cold sore on 01Feb2021. She was wondering if she is okay to use an anti-viral product. The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/31/2021,02/01/2021,1.0,UNK,,,,,,['Oral herpes'],1,PFIZER\BIONTECH, 1068118,CT,,F,"Shortness of breath; Rapid heartbeat; Rash; Itching; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot/batch number and expiry date unknown), via an unspecified route of administration on an unspecified date at single dose for an unspecified indication. The patient's medical history included she was allergic to silicone and sulfur. The patient's concomitant medications were not reported. The patient received the COVID vaccine on an unspecified date (reported as Friday) and two hours later, she experienced shortness of breath, rapid heartbeat, rash, and itching. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Allergy to chemicals; Drug allergy,,,"['Dyspnoea', 'Heart rate', 'Heart rate increased', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH, 1068119,,,F,"Covid vaccine 14 days ago and then contracted Covid/2 weeks afterward she became infected with covid; Covid vaccine 14 days ago and then contracted Covid/2 weeks afterward she became infected with covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program . A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she received the Covid vaccine 14 days before 01Feb2021 and then contracted Covid. She got the first dose of the covid vaccine on 23Dec2020, 2 weeks afterward (Jan2021) she became infected with covid. The outcome of events was unknown. Patient wanted to know when she can get the 2nd dose or how to proceed. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/01/2021,9.0,UNK,,,,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1068120,WA,,M,"severe eye pain in right eye; couldn't see or read; big increase in blood pressure and temperature; big increase in blood pressure and temperature; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient himself) reported that a male patient of an unspecified age received the first (1st) dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he had reaction to vaccine and stated that on the day of the vaccine on an unspecified date in Jan2021, he had severe eye pain in right eye, went to bed that night, and woke up next morning, couldn't see or read even using his eye glasses. He went to a pharmacy and bought some cheap reading glasses, but it didn't help much. The last couple of days on an unspecified date in 2021, the patient had big increase in blood pressure and temperature, but it didn't feel bad. Therapeutic measures were taken as a result of the event ""couldn't see or read."" The patient was not recovered from the event ""couldn't see or read,"" while the outcome of the events ""severe eye pain in right eye and big increase in blood pressure and temperature"" was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['Blood pressure increased', 'Blood pressure measurement', 'Body temperature', 'Body temperature increased', 'Eye pain', 'Visual impairment']",1,PFIZER\BIONTECH, 1068121,MA,,F,"tingling on her mouth; had some tingling on her mouth and face; This is a spontaneous report from a contactable physician reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient called and stated she sent in a report on the report line already. She was going to her HCP today at 11:30AM and added she got the first dose on 29Jan2021 and one and one half hours later she had some tingling on her mouth and face that lasted about two hours. She has a lot of drug allergies and she told them and they kept her for 30 minutes. She added she was a physician and she read on the CDC website and it sounded like she had an allergic reaction. She was dismayed now as the recommendation looks like she should not get the second dose but that information was dated Dec2020. She was asking if we have any more current information regarding recommendations for receiving the second dose and confirmed she has no new events to report today and she did previously provide all product information including lot number. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Drug allergy,,,"['Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH, 1068122,,,F,"last dose of Covid vaccine on 9Jan and then had an antibody test on the 27 and it came back negative; This is a spontaneous report from a contactable pharmacist (patient) via Pfizer-sponsored program. A female patient of an unspecified age received the second single dose of BNT162B2 (PFIZERBIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 09Jan2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first single dose of BNT162B2 (Pfizer BioNTech) on an unspecified date for COVID-19 immunization. The patient received both doses of the Pfizer BioNTech COVID-19 vaccine. The patient's last dose of Covid vaccine was on 09Jan2021 and then had her blood tested on 27Jan2021. She wasn't sure about the type of test that she had but she had mentioned a ""polypeptide nucleotide test"" and said that she had the standard test for all blood centers. She further stated that her antibody test came back negative. She was wondering if the test should show that she has antibodies. She wanted to know if that was typical. The event was assessed as non-serious. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,01/27/2021,18.0,UNK,,,,,,"['Blood test', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 antibody test negative']",2,PFIZER\BIONTECH, 1068123,,,F,"Got Covid after getting the 1st dose of the vaccine; Got Covid after getting the 1st dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 12Jan2021 (reported as 20 days ago from the time of the report) at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was supposed to go in tomorrow (02Feb2021) and get her 2nd dose, but she got COVID after getting the 1st dose of the vaccine on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1068124,PA,48.0,F,"Positive Rapid COVID-19 Test on the 29th; This is a spontaneous report from a Pfizer-sponsored program. A contactable other healthcare professional (HCP) reporting for herself reported that a 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 22Jan2021 at singe dose for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient experienced Positive Rapid COVID-19 Test on 29Jan2021, and she was due for her second COVID test on 17Feb2021, so she was calling to see if it was still okay for her to get her second dose of the vaccine as scheduled, since she has now had COVID. The patient stated that she did not think there was anything else relevant, other than the fact that she was in contact with people who were potentially COVID positive in the facility where she works. Patient stated that they perform COVID testing at her job, so she was around people who were suspected to have COVID. The outcome of the event was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: There is no reasonable possibility that the event ""positive rapid COVID19 test"" within 7 days from the administration of the first dose was related to BNT162b. This is more likely associated with an earlier acquired infection during these pandemic times.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/29/2021,7.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068125,FL,,F,"headache; This is a spontaneous report from a contactable consumer (patient's husband) via a Pfizer-Sponsored Program. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: UNKNOWN) via an unspecified route of administration on 21Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced headache. The reporter and the patient both had their Pfizer COVID-19 vaccines on 21Jan2021, and the second dose would be given on 11Feb2021. The reporter stated that the patient had a very bad headache now and wanted to know if she could take Excedrin Migraine because this is what she had been using in the past when she had a headache. The clinical outcome of the event headache was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,,,UNK,,,,,,['Headache'],1,PFIZER\BIONTECH, 1068126,TX,,M,"covid positive; covid positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (wife) reported that a male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller calling on behalf of the husband who was in a long term care facility. He was given 1st dose on 23Jan2021, thereafter tested covid positive in 2021. He was scheduled to receive the 2nd dose on 23Feb2021. He was advised not to have it because he tested positive. Wife wanted to know if it's true. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068127,CT,,F,"mild soreness on injected arm after the first dose; This is a spontaneous report from a contactable nurse (the patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the arm on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know if she could take painkillers before and after her second dose. She mentioned having mild soreness on injected arm after the first dose (unspecified date). The patient had one dose of the Pfizer-BioNTech COVID-19 Vaccine and didn't take any pain killers. She just had a slightly sore arm. She heard something about the second dose can give you a headache. She asked what was recommended on taking pain medication like acetaminophen, ibuprofen, or diphenhydramine hcl (BENADRYL) before and/or after vaccination? The clinical outcome of mild soreness on injected arm after the first dose was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101338 Pfizer",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1068128,VA,29.0,F,"fever; chills; aches; headache; fatigue; loss of appetite; Dulled taste; patient received the first dose on 12Jan2021 and the second dose was on 29Jan2021; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: El9362; expiration date: unknown) at vaccination age of 29-year-old via an unspecified route of administration in the left arm on 29Jan2021 16:45 at a single dose for covid-19 immunization. Medical history included hypothyroidism, PCOS (polycystic ovarian syndrome) and penicillin allergy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included levothyroxine, metformin and vitamin nos (MULTIVITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: Ek4176) at vaccination age of 29-year-old via an unspecified route of administration in the left arm on 12Jan2021 16:45 at a single dose for covid-19 immunization but had lump on neck, sore arm, diarrhea starting day 3 through today and sore rib. The patient received the most recent COVID-19 vaccine in a hospital. It was reported that the patient received the first dose on 12Jan2021 and the second dose was on 29Jan2021. On an unspecified date after the second dose, the patient had fever, chills, aches, headache, fatigue, loss of appetite and dulled taste. It was unknown if the patient received treatment for the adverse events and events were considered as non-serious. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,PVT,LEVOTHYROXINE; METFORMIN; MULTIVITAMINS [VITAMINS NOS],,Medical History/Concurrent Conditions: Hypothyroidism; Penicillin allergy; Polycystic ovarian syndrome,,,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Inappropriate schedule of product administration', 'Pain', 'Pyrexia', 'Taste disorder']",2,PFIZER\BIONTECH, 1068129,MA,71.0,M,"headaches for a week; This is a spontaneous report from a contactable other healthcare professional (patient himself). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), intramuscularly on the left arm, on 05Jan2021 14:00, at single dose, for covid-19 immunization. Medical history included chronic back pain, blood pressure, and pain. Unspecified concomitant medications were taken for blood pressure and pain. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the first injection, the patient had headaches for a week on Jan2021. No treatment was received for the headaches and the patient recovered from it on Jan2021. The patient has not been COVID-tested post-vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/01/2021,,PVT,,,Medical History/Concurrent Conditions: Blood pressure abnormal; Chronic back pain; Pain,,,['Headache'],1,PFIZER\BIONTECH,OT 1068130,TX,62.0,F,"Body aches; Puttered around the house, then lost energy around noon; headache upon waking; felt like I had a hangover; Lethargic all day; Fever 99.5-100.2; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of BNT162B2 (lot number: El9265), via an unspecified route of administration on 29Jan2021 13:00 at single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included levothyroxine sodium (UNITHROID). The patient previously took first dose of BNT162B2 (lot number: El324) at the age of 62 year-old on 08Jan2021 13:00 in the left arm and experienced minor injection site soreness. On 30Jan2021 07:00, the patient experienced headache upon waking Saturday morning and felt like she had a hangover. She felt lethargic all day. She had fever 99.5-100.2 from 7pm- 9pm on Saturday night. She experienced body aches on Sunday morning, 31Jan2021. Puttered around the house, then lost energy around noon. She felt ok but not back to normal energy level yet. Stated she is going to work tomorrow. The patient was not pregnant at the time of vaccination. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 99.5-100.2 on 30Jan2021. The outcome of the events was recovered in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,UNK,UNITHROID,,,,,"['Asthenia', 'Body temperature', 'Hangover', 'Headache', 'Lethargy', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1068131,CA,44.0,M,"injection site soreness; severe back pain; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982), via an unspecified route of administration into the left arm on 29Jan2021 10:15 AM at a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date prior to vaccination. The patient's concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration into the left arm on 09Jan2021 08:30 AM at a single dose for COVID-19 immunization and experienced injection site soreness. On 30Jan2021, patient experienced injection site soreness and severe back pain. The events were reported as non-serious and the patient was treated with diclofenac 100mg. Outcome of events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,WRK,,,Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination),,,"['Back pain', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1068132,IL,,F,"flu-like symptoms; headache; fatigue; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history included seizure disorder, depression, anxiety, mild hyperthyroidism and allergies to penicillin. Concomitant medication included carbamazepine, citalopram, buspirone hydrochloride (BUSPAR) and omeprazole. The patient previously received the first dose of BNT162B2 on 17Dec2020 (Age at vaccination: 41 years) for COVID-19 immunisation and experienced flu-like symptoms, headache, aches, chills, night sweats and more fatigue than normal. The patient experienced flu-like symptoms on an unspecified date. It was reported that with the second shot, the patient took ibuprofen shortly after receiving it and mainly had a headache and fatigue. Just for 24 hours after the shot did the patient have symptoms. The outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,PVT,CARBAMAZEPINE; CITALOPRAM; BUSPAR; OMEPRAZOLE,,Medical History/Concurrent Conditions: Anxiety; Depression; Hyperthyroidism (mild hyperthyroidism); Penicillin allergy; Seizure (Seizure disorder),,,"['Fatigue', 'Headache', 'Influenza like illness']",2,PFIZER\BIONTECH, 1068133,,,F,"headache after the second shot; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable healthcare professional (HCP) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on an unknown date (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on an unknown date with no adverse effect reported. The patient completed the vaccination series, and she took some pain reliever for her headache after the second shot. The outcome of the event headache was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Headache'],2,PFIZER\BIONTECH,OT 1068134,FL,72.0,F,"She has started developing rash all over her neck and now coming on to arm, it's a very bad rash; Right now it is getting kind of worse; She is feeling very bad after the vaccine; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient started to receive bnt162b2 (BNT162B2 also reported as Pfizer Covid vaccine, lot ENS318), via an unspecified route of administration from 30Jan2021 to 30Jan2021 at SINGLE DOSE for an unspecified indication. The patient's medical history was not reported. Concomitant medications included diclofenac, gabapentin, losartan, levothyroxine sodium (SYNTHROID), vitamin C (ASCORBIC ACID) and ergocalciferol (VITAMIN D). On 31Jan2021, she was feeling very bad after the vaccine administration and started developing rash all over her neck and now coming on to arm. Reported that it's a very bad rash and right now it was getting kind of worse (no treatment). The outcome of rash aggravated was not recovered; for other event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/31/2021,1.0,UNK,DICLOFENAC; GABAPENTIN; LOSARTAN; SYNTHROID; VITAMIN C [ASCORBIC ACID]; VITAMIN D [ERGOCALCIFEROL],,,,,"['Feeling abnormal', 'Rash']",UNK,PFIZER\BIONTECH, 1068135,AL,,F,"Irritation and redness in both eyes; Flushing of the face; Irritation and redness in both eyes; This is a spontaneous report received from a non-contactable consumer (patient herself). An elderly female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number: EL9264), via an unspecified route of administration on arm left on 05Feb2021 16:15 at single dose for COVID-19 immunisation at hospital. Medical history included occasional rosacea with stress or excitement. Concomitant medication included metformin and zinc, which are received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took tetracycline and experienced allergy. On 05Feb2021 16:30, the patient experienced irritation and redness in both eyes and flushing of the face. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not received any treatment for the events. The events were assessed as non-serious by the reporter. Outcome of the events was recovered on unspecified date in 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,PVT,METFORMIN; ZINK,,Medical History/Concurrent Conditions: Excitement (Occasional rosacea with stress or excitement); Rosacea; Stress (Occasional rosacea with stress or excitement),,,"['Eye irritation', 'Flushing', 'Ocular hyperaemia']",UNK,PFIZER\BIONTECH, 1068136,MI,54.0,F,"exhausted; body aches; headache; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient (non-pregnant) received second dose of (BNT162B2, Solution for injection, Batch/lot: EL3248), via an unspecified route of administration on 03Feb2021 14:30 at single dose in left arm for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Historical vaccine of BNT162B2 for covid-19 immunisation, (administration date: 15Jan2021, time=02:30 PM, vaccine location: Left arm, dose number: 1, lot number: EL3248). Concomitant medication included desvenlafaxine succinate (PRISTIQ), levofloxacin (LEVOXAL), ergocalciferol (VIT D), ascorbic acid (VIT C), zinc, calcium. The patient was exhausted, body aches and had headache on 04Feb2021 and it started 04:30 AM. The treatment was not received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies. The outcome of the events was recovered on an unspecified date of Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/04/2021,1.0,WRK,PRISTIQ; LEVOXAL; VIT D; VIT C; ZINC; CALCIUM,,,,,"['Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH, 1068137,MI,52.0,F,"I slept all day; I could not eat; I could not get out of bed, I hurt so bad/Body aches; Muscle spasms; Headache; Tired; I had a 100.4 temperature for 2 days; This is a spontaneous report from a contactable consumer (reporting for herself). A 52-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 29Jan2021 to 29Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for unspecified indication. On 30Jan2021, the patient stated that ""I slept all day, I could not eat, I could not get out of bed, I hurt so bad and has body aches, muscle spasms, headache, tired and I had a 100.4 temperature for 2 days."" The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Nov2020. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/30/2021,1.0,UNK,ADDERALL,,,,,"['Decreased appetite', 'Fatigue', 'Headache', 'Muscle spasms', 'Pain', 'Pyrexia', 'Somnolence']",1,PFIZER\BIONTECH, 1068138,CT,78.0,M,"Mild soreness at the injection site; This is a spontaneous report from a non-contactable consumer (patient). A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EM9809), via an unspecified route of administration on left arm on 08Feb2021 at the age of 78 years old at a single dose for COVID-19 immunisation at Doctor's office/urgent care. Medical history included high cholesterol. Allergies to medications, food, or other products was none. Concomitant medications included unspecified medications. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received at the age of 78 years old on an unknown date for COVID-19 immunization. On 08Feb2021, the patient experienced mild soreness at the injection site. The patient assessed the event as non-serious. It was unknown if the treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the event. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/08/2021,0.0,OTH,,,Medical History/Concurrent Conditions: Cholesterol high,,,['Vaccination site pain'],2,PFIZER\BIONTECH, 1068139,CT,78.0,F,"Very mild soreness at the injection site; Very Mild fatigue; This is a spontaneous report from a non-contactable consumer (female patient). A 78-year-old female non pregnant patient received second dose of bnt162b2 (Formulation: Solution for injection, Lot number: em9809) via unspecified route of administration on left arm, on an unknown date at single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient previously took historical vaccine, first dose of bnt162b2 for COVID-19 immunization. It was reported that the patient experienced very mild soreness at the injection site and very mild fatigue on 08Feb2021. The patient administered most recent COVID-19 vaccine at doctor's office/urgent care, had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medication (unspecified) within 2 weeks of vaccination (as reported). The patient didn't receive treatment for the adverse events. The patient had not diagnosed with COVID-19 prior to vaccination and since the vaccination. It was reported that patient had no allergies to medications, food, or other products. The seriousness of the events was reported as non-serious by the reporter. The outcome of the events was reported as recovered on an unknown date in Feb2021. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,02/08/2021,,OTH,,,,,,"['Fatigue', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1068140,,,U,"Muscles were aching on the opposite shoulder/Neck and back and shoulders, arms; I do get achy muscles; Rash like dry skin on cheeks and like nose; it's red, kind of burns but it's not hot; Rash like dry skin on cheeks and like nose; it's red, kind of burns but it's not hot; Not feeling well/not feeling really good; Rash like dry skin on cheeks and like nose; it's red, kind of burns but it's not hot; Muscles were aching on the opposite shoulder/Neck and back and shoulders, arms; I do get achy muscles; Muscles were aching on the opposite shoulder/Neck and back and shoulders, arms; I do get achy muscles; Muscles were aching on the opposite shoulder/Neck and back and shoulders, arms; I do get achy muscles; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration (right arm) on Jan2021, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the shot on Friday and patient believes patient is having reactions to this, patient is not sure because it was not really listed. First of all, they mentioned like muscle aches on where you got the shot but patient's muscles were aching on the opposite shoulder. Patient got the shot in the right arm and patient's muscles were aching on the other side. That's one minor thing because it's like in patient's neck and back and patient's shoulders, like patient's arms. Patient do get achy muscles now and then. Paitent noticed that, the first thing, patient doesn't know if it's possible that it could be on the other of the side of that. It could be one of them but that's not what is really concerning patient. Actually, the one thing it said on the thing that it's a possibility you might get a puffy face. Patient has a rash, like dry, dry skin on patient's cheeks and like patient's nose and it's red that's one thing. Patient was sure that's from the shot. But patient's real concern, patient's main concern is, patient was in home service. Patient helps out people that are either handicapped or whatever and patient want to get this done. Does this mean patient should not have the second shot because patient was having like the red face, it kind of burns but it's not hot.Patient was not feeling really good because of the shot. This was the only number that patient was given when patient got the shot and patient would like to know what your purpose is. Patient was so angry for this (call issue). The outcome of the events was unknown. Information on the Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['Back pain', 'Burning sensation', 'Dry skin', 'Malaise', 'Myalgia', 'Neck pain', 'Pain in extremity', 'Rash']",1,PFIZER\BIONTECH, 1068141,IN,83.0,F,"she was not feeling well/she just has not felt good, just have felt blah; just can't taste anything; pain in her arm; Injection site did have a little pain; Tiredness; Muscle pain; This is a spontaneous report from a contactable consumer (patient herself). An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262), via an unspecified route of administration, on 28Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on 08Jan2021 for covid-19 immunization and experienced couldn't taste anything. The patient called about the vaccine as she was having some effects. She stated she got the first shot on 08Jan2021 and, last 28Jan2021 she got the second shot. She informed she was given a ""paper"" to tell her of the effects that one might possibly have when getting the shot, and then she checked all of those. On 30Jan2021, 2 days after the shot, she was not feeling well. She stated her injection site did have a little pain on Jan2021, but it was okay, it went away the next day. She also had on Jan2021 some tiredness and muscle pain which was on there; other than that, she just has not felt good, just have felt blah. She informed that her lymph nodes were not swollen, and she has not been nauseated or have had any of these things written on the paper. She also informed having read on the paper that ""the people with Covid-19 and it gave the symptoms of people with COVID 19 and one of them was loss of taste, and smell was okay"". She then added that after she got her first shot, she noticed once in a while she couldn't taste anything but that wasn't all the time. But now, since she got the second shot, it seemed like all day yesterday, 30Jan2021, and this morning also, that she just can't taste anything. Then she stated ""So, my problem is, would that be a result of the shot?"" She stated she was feeling a little bit better today other than that, her mouth - she can't taste anything. Also, yesterday, she took an extra strength Tylenol every 4 hours to try to help with the pain in her arm on Jan2021; but she has not taken any today. She was just trying to help her arm feel better. The outcome of the event injection site did have a little pain was recovered on Jan2021. The outcome of the event she was not feeling well/she just has not felt good, just have felt blah was recovering. The outcome of the event just can't taste anything was not recovered. While the outcome of all other remaining events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/01/2021,,UNK,,,,,,"['Ageusia', 'Fatigue', 'Malaise', 'Myalgia', 'Pain in extremity', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1068142,CA,78.0,F,"I started really scratching and it's really is pink red pumps on my stomach; it spread my whole stomach, then over the breast and under the arm, around my back; rash; I started really scratching and it's really is pink red pumps on my stomach; it spread my whole stomach, then over the breast and under the arm, around my back; rash; I started really scratching and it's really is pink red pumps on my stomach; it spread my whole stomach, then over the breast and under the arm, around my back; rash; Blood sugar was very high; Blood pressure was very high; I had shingles on it; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 29Jan2021 (at 78-year-old) at single dose for COVID-19 immunization (Because she was of that age and she wanted to travel again). Medical history included ongoing Diabetic. There were no concomitant medications. Reason for no lot number of COVID 19 Vaccine, consumer stated, ""It says Pfizer, EL9267, no 62, I am not sure now. Maybe I think it says 2, it's a 2."" She woke up at 1 in the morning and started really scratching (31Jan2021) and it's really is pink red pumps (31Jan2021) on her stomach. It started to spread in the whole stomach, then over the breast and under the arm, around her back. She had the reactions. It was a total rash (31Jan2021) and red. She took her blood sugar, she was diabetic, her blood sugar was very high (Jan2021), then she took her blood pressure, her blood pressure was very high (Jan2021). She was all ready to go to the hospital because when you have a rash that's not good. But now 3 hours later her rash disappeared and she felt much better again. When confirmed if the consumer wanted to report the same or have some questions, consumer stated, that she have question, why did she get the rash after she had the COVID vaccine, she had her shot on Friday, Pfizer shot vaccine on Friday. She stated that she felt better, she only have a little bit in her back itching. But everything else it was so red, she meant she had shingles (Jan2021) on it. It's the hospital who gave her the shot. Due date for the next shot was on 19Feb2021. It was stated that she is Diabetic, she don't take any medication, she did it on her own and she is border lined. On lab work, consumer stated that every half a year she had a blood test. Regarding treatment, the consumer stated that she didn't take anything, she was wondering if she was allowed to take anti-histamine. The outcome of the event Itching and Redness was recovering, rash was recovered, while other events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/01/2021,,PVT,,Diabetic,,,,"['Blood glucose', 'Blood glucose increased', 'Blood pressure measurement', 'Blood test', 'Erythema', 'Herpes zoster', 'Hypertension', 'Pruritus', 'Rash']",UNK,PFIZER\BIONTECH, 1068143,IN,83.0,F,"after I got my first shot, I noticed once in a while I couldn't taste anything; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 08Jan2021 at a single dose for covid-19 immunisation (because they want everybody to have the vaccine and age). The patient has no medical history and concomitant medications. After the patient got her first shot, she noticed once in a while that she couldn't taste anything but that wasn't all the time. The patient stated that they want everybody to have the vaccine and age. And they started with the older people which that is her, she was 83 so that's the reason she was getting it. It was not a prescription; in her town, they are giving them free. So, the patient did not have to have a prescription. They went by age. The outcome of the event was unknown. Information about Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,,,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No",,,['Ageusia'],1,PFIZER\BIONTECH, 1068144,,,U,"Nauseous; I am not feeling good; Vomiting; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EL9261), via an unspecified route of administration, on 29Jan2021 at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Patient stated receiving COVID vaccine on Friday (29Jan2021) and have been nauseous and vomiting from an unspecified date and was asking if it was normal. Patient also reported not feeling good from an unspecified date. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,,,UNK,,,,,,"['Malaise', 'Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH, 1068145,NY,,F,"Fatigue extreme; Terrible headache bordering on a migraine; Terrible headache bordering on a migraine; Muscle pain; Feeling unwell; Joint pain; bloody nose, a little bit of the bloody nose when she blew it; Some blisters on my lips; Nausea; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the upper left arm, 28Jan2021 16:11 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient had extreme fatigue, terrible headache bordering on a migraine, muscle pain, joint pain, nausea and just feeling unwell and also had a bloody nose, a little bit of the bloody nose when she blew it and some blisters on her lips. Patient was just putting some Vaseline on her lips and to the migraine she took Imitrex. She have had a headache every single day, very bad. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,,,PVT,,,,,,"['Arthralgia', 'Epistaxis', 'Fatigue', 'Headache', 'Lip blister', 'Malaise', 'Migraine', 'Myalgia', 'Nausea']",UNK,PFIZER\BIONTECH, 1068146,IL,66.0,M,"soreness, really bad in my shoulder; soreness, really bad in my shoulder and left side of the neck; Dizzy; Achy bones; Hands were very stiff; sore; This is a spontaneous report from a contactable consumers (patient and patient's wife). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265 and expiry date: 31May2021), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure and cholesterol from an unknown date and unknown if ongoing. Concomitant medication included metoprolol for blood pressure and atorvastatin (lot number: E003816) for cholesterol. The patient stated, ""My wife and I have received Pfizer's COVID-19 Vaccine, yesterday, around this time, noon. I was fine. I didn't feel any discomfort in my shoulder but later on at night, it started getting sore on 30Jan2021. And then, this morning 31Jan2021, I woke up with a soreness, really bad in my shoulder, my left shoulder and also my left side of the neck. And I woke up really like dizzy and achy bones. My hands were very stiff which I have never experienced that. And I was a little scared if that was a side effect and if they are going to continue for a long time? No lab work done"". The patient took Tylenol or Aleve 6 hours apart as treatment for the events. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,01/30/2021,0.0,UNK,METOPROLOL; ATORVASTATIN,,Medical History/Concurrent Conditions: Blood cholesterol abnormal; Blood pressure abnormal,,,"['Arthralgia', 'Bone pain', 'Dizziness', 'Musculoskeletal stiffness', 'Neck pain', 'Pain']",UNK,PFIZER\BIONTECH, 1068147,TX,86.0,F,"Blisters in my mouth, my tongue; Blisters in my mouth, my tongue; Hadn't have any other symptoms except I had not been feeling right that I had been feeling real bad.; All blistered and swollen ; whole mouth is sore and my tongue is blistered; Big blotch, not at the injection site but below it, it was red, swollen and itchy; All blistered and swollen ; whole mouth is sore and my tongue is blistered; All blistered and swollen ; whole mouth is sore and my tongue is blistered; Tongue is tightening; I think that was a symptom of Covid, called Covid tongue; This is a spontaneous report from a contactable consumer (patient). An 86-year- old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318 and expiration date not provided), via an unspecified route of administration second dose on 26Jan2021 at single dose for Covid-19 immunization. The patient's medical history included High Blood Pressure. The patient's concomitant medication included amlodipine, alendronate sodium, hydrochlorothiazide, levothyroxine, losartan for Hypertension, and simvastatin. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 and expiration date not provided) first dose on 05Jan2021. It was reported that patient had the second dose 5 days ago on 26Jan2021 and three days after the patient got the vaccine on 29Jan2021 the patient experienced got all these blisters in my mouth, my tongue and everything, top of my tongue is tightening. The patient wonder if that was a type of reaction from the vaccine. The patient think that was a symptoms of Covid, called Covid tongue. The patient did not know if she should go to the doctor or thought that it was just a reaction. It was still on, it was 5 days now and it was still all blistered and swollen. The whole mouth was sore and patient tongue was blistered. The patient did not have any other symptoms except the patient had not been feeling right that I had been feeling real bad. The patient had a real big blotch, not at the injection site but below it, it was red, swollen and itchy but other than that I have nothing and I just know for sure I hadn't heard of anything that there had been a reaction from the vaccine. The patient wanted was wondering if these reaction was from the vaccine or you think I should go, get tested? The events Oral mucosal blistering, Tongue blistering, Oral pain, Swollen tongue, Mouth swelling, and Tongue disorder was treated with mouth wash. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/29/2021,3.0,UNK,AMLODIPINE; ALENDRONATE SODIUM; HYDROCHLOROTHIAZIDE; LEVOTHYROXINE; LOSARTAN; SIMVASTATIN,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Feeling abnormal', 'Mouth swelling', 'Oral mucosal blistering', 'Oral pain', 'Rash macular', 'Suspected COVID-19', 'Swollen tongue', 'Tongue blistering', 'Tongue disorder']",2,PFIZER\BIONTECH, 1068148,CA,45.0,M,"Weird rash on that arm on his forearm, on the top of the elbow and then he kind of started on the other arm and then on the legs a little bit, around his belly; His tongue looks like he has swollen taste buds or something; Itchy; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247) intramuscular on the right arm on 21Jan2021 at a single dose for COVID-19 immunization. The patient had no medical history. Concomitant medications included supplements and vitamins. The patient got the COVID Vaccine on the 21st of January the Pfizer one and the following day he felt fine but he has this weird rash on that arm on his forearm, on the top of the elbow and then he kind of started on the other arm and then on the legs a little bit, around his belly and then his tongue looked like he has swollen taste buds or something, but he said he felt fine but the reporter don't if that's a side effect. ""Should he be worried, should he go to a doctor?"" Reporter stated, ""Because we weren't sure what it was, he did take one Benadryl like the ones you find at the drug store and then that was it. And then I put Calamine lotion, so topically couple times just to prevent him from scratching but not regularly just when he feels really, really itchy."" Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Pruritus', 'Rash', 'Swollen tongue']",UNK,PFIZER\BIONTECH,OT 1068149,OK,72.0,M,"really tired; headache; started throwing up; diarrhea; dry hives; feeling kind of 'wheezy'; stomach was still upset; couldn't breathe, little short breath; Feeling lousy; I had a temperature; heavy sweat; This is a spontaneous report from a contactable consumer (patient). A 72-year-old-male patient received first dose of BNT162B2 (Pfizer COVID vaccine), lot no. EL9261, via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. Medical history included Histoplasmosis (it's a lung fungus), Hepatitis B, and meningitis. Concomitant medications included unspecified blood thinner. The patient got the first Pfizer COVID shot Friday morning. He experienced feeling lousy. And about 2 o'clock in the afternoon on 29Jan2021, he started feeling kind of 'wheezy' as by 1 o'clock and his stomach (incomplete sentence). At 3 o'clock, he started throwing up, he had the dry hives for about 3 hours along with diarrhea. And then he had a temperature. He laid down and woke up just heavy sweat on the break down he meant big time. At 2 in the morning (30Jan2021) he couldn't breathe, little short breath and that lasted about 3 hours that was Friday night. On Saturday (30Jan2021), his stomach was still upset with diarrhea, still had the headache and really tired on Saturday and today Sunday. No treatment received for the events. He asked if he should take the second shot. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Hepatitis B; Histoplasmosis (It's a lung fungus); Meningitis,,,"['Abdominal discomfort', 'Body temperature', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Malaise', 'Pyrexia', 'Urticaria', 'Vomiting', 'Wheezing']",1,PFIZER\BIONTECH, 1068150,OK,78.0,M,"Shoulders was all sore both of them; He was sore all over; Chills; Running 101 fever; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 29Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included COVID-19 (reported as ""has had that virus before""). There were no concomitant medications. On 30Jan2021, in the morning after the vaccination, the patient's shoulders were both sore. By the afternoon of the same day, the patient was sore all over, ran in a 101 fever (unit was not reported), and was having chills. The patient did not receive any treatment for the reported events. The outcome of the events, 'shoulders were both sore', 'sore all over', 'ran in a 101 fever' and 'chills', was recovering; patient was feeling better at the time of reporting. Information on lot/ batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Arthralgia', 'Body temperature', 'Chills', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 1068151,NC,73.0,F,"When I cough it was blood in that cough couple of times; Left leg swell up from my feet to all the way up; When I woke up, I didn't know what time, what date, nothing; I was all confused; Feeling achy/ body ache; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (Pfizer COVID vaccine), lot no. EL347, via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization at a health department because she was at high risk and she was 73. Medical history was not reported. Concomitant medications included unspecified medications. The patient had an injection done 2 weeks, not this last Friday, the Friday before that. They had to make her wait for half an hour before she left and she was okay. Then Saturday (23Jan2021), she started feeling achy but to she was okay. Then Sunday (24Jan2021), she had a very bad experience, she went and start watching TV and she fell asleep. When she woke up, she didn't know what time, what date, nothing. And she looked at the time on her TV and it said 6:45, she didn't know if it was am or pm. And it was dark outside and she didn't know if it was Monday or Sunday. She was all confused, she called someone to make sure what day and time and all and still she was still confused. And then she had to call her aunt and then she told her no it's Sunday and it's night time and so on. Then she got better. Then during the week she didn't have that much body ache, she expected that because that was in that papers. Then today is Sunday, Friday morning (29Jan2021) she got up and she coughed, when she coughed it was blood in that cough couple of times. Then her daughter came over and took her to the hospital (hospitalization details were not clarified). She had lab work the day they took her in the emergency room. At the hospital, they did all kind of tests, on top of that her leg, her left leg swelled up from her feet to all the way up, all the way up. They thought that it could have been some blood clot. And they took test and all and nothing, everything was okay. They couldn't find out why her whole leg was swollen. On top of that, they did chest x-ray and they did something else she can't remember, another test. And they took all kind of blood work and all. And they did to see if she had the virus, the COVID. And yesterday they called her from the hospital and they said that she didn't have the virus. And she asked them about the blood work and they told her if there was anything more than they would call her. So, she thinks all this came from that injection. She called because this was not guaranteed if this was from injection. When confirmed that COVID test was negative and blood work report was not out, she stated they haven't called her that meant her blood work was okay. The swollen leg has been gone down and blood once in a while she sees a little bit. They gave her 2 prescriptions, one was antibiotic and one is steroid. Due date for the next shot is 12Feb2021. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/23/2021,1.0,UNK,,,,,,"['Blood test', 'Chest X-ray', 'Confusional state', 'Haemoptysis', 'Laboratory test', 'Pain', 'Peripheral swelling', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068152,CO,77.0,F,"dizzy; broke out into a sweat; feeling a little nauseous; chills; breast cancer stage 1/taking anastrozole; breast cancer stage 1/taking anastrozole; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ELV5318, expiry date unknown), via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunization. Medical history included stage 3 kidney disease, breast cancer stage 1 and blood pressure abnormal (reported as 'blood pressure') all from an unknown date and all ongoing. Concomitant medication included anastrozole (manufacturer unknown) for breast cancer, levothyroxine (manufacturer unknown) for kidney disease and amlodipine (manufacturer unknown) for blood pressure. The patient has breast cancer stage 1 and was taking anastrozole. The patient got the vaccine on 30Jan2021 and did not have any side effects 22 hours later, on the day of the report, 31Jan2021. The patient was grocery shopping and became very dizzy and thought she has to keep this together. The patient then just broke out into a sweat and managed to get herself home. She was feeling a little nauseous and she got the chills and then it (unspecified) was pretty much over in about 2-3 hours. The patient was scheduled for the second dose on 20Feb2021. The patient did not receive any treatment for the events. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,01/30/2021,0.0,UNK,ANASTROZOLE; LEVOTHYROXINE; AMLODIPINE,Blood pressure abnormal; Breast cancer stage I; Kidney disorder,,,,"['Chills', 'Dizziness', 'Hyperhidrosis', 'Nausea', 'Off label use', 'Product use issue']",1,PFIZER\BIONTECH, 1068153,,39.0,M,"Fever; This is a spontaneous report from a contactable other health professional. A 39-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EN5318, via an unspecified route of administration on 29Jan2021 15:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on 08Jan2021, 22:00 in the Left arm, for COVID-19 immunization (first dose). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient experienced fever on 30Jan2021 09:00. The outcome of event was recovered. The patient did not receive any treatment due to the event. Follow-up attempts are completed. The following information on the batch number has been obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,PVT,,,,,,['Pyrexia'],2,PFIZER\BIONTECH, 1068154,MO,22.0,M,"Started with soreness in the arm; Turned into horrible muscle and joint aches; Turned into horrible muscle and joint aches; pounding headache; an immense amount of pressure behind the eyes; uncontrollable body aches; This is a spontaneous report from a contactable other hcp (patient). A 22-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=En5318), via an unspecified route of administration on 29Jan2021 11:30 (at 22-year-old) at single dose (Right arm) for COVID-19 immunization. The patient medical history was not reported. Patient had known allergies. Facility type vaccine was Public Health Clinic/Veterans Administration facility. No other vaccine was administered in four weeks. No other medications in two weeks. Patient had no covid prior to vaccination. The patient was covid tested post vaccination. There were no concomitant medications. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El3248), on 08Jan2021 12:00 (at 22-year-old) on Right arm for COVID-19 immunization. It was reported that it started with soreness in the arm. Turned into horrible muscle and joint aches, pounding headache, an immense amount of pressure behind the eyes, and uncontrollable body aches. This lasted from about 12 hours and then got progressively better. By hour 48 he was totally fine. Events started on 29Jan2021 22:00. No treatment was received for events. The patient underwent lab tests and procedures which included covid test: Nasal Swab: negative on 31Jan2021. The outcome of the events was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PUB,,,,,,"['Arthralgia', 'Headache', 'Myalgia', 'Ocular discomfort', 'Pain', 'Pain in extremity', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1068155,NY,64.0,F,"mild headache; tiredness; bruised arm not at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 64 -year-old female (not pregnant at time of vaccination) patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Ek9231), via an unspecified route of administration (on the left arm) on 07Jan2021 14:30 (at the age of 64-years-old), single dose for COVID-19 immunization. Relevant medical history included Allergies, mvp, hbp, thalassemia all from an unknown date. The patient's concomitant medication was not reported. The patient experienced mild headache, tiredness and bruised arm not at injection site, all from an unknown date. The patient underwent lab tests and procedures which included sars-cov-2 test on 10Jan2020, 15May2020 and 01Oct2020, all negative. Patient has no other vaccine in four weeks. No covid prior to vaccination. No treatment received for the adverse events. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021143321 same reporter/patient/drug, different events separated with time",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/07/2021,,,PVT,,,Medical History/Concurrent Conditions: Blood pressure increased; Mitral valve prolapse; Thalassemia,,,"['Contusion', 'Fatigue', 'Headache', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068156,TN,80.0,M,"bad body rash; shingles; This is a spontaneous report from a contactable consumer (wife). An 80-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) via an unspecified route of administration in the right arm on an unspecified date (about three weeks ago) at a single dose for COVID-19 immunisation. There were no medical history and no concomitant medications. The reporter noted that both she and her husband took the Covid vaccine about 3 weeks ago, stated is time to take the second part. She read the pamphlet that came with it when we got the vaccine, said that a person could have a bad body rash. She stated her husband has had a bad body rash on an unspecified date. Noticed the rash right away, maybe the day or two after and it has persisted since, it was a nightmare for him, that she thought it was shingles on unspecified date. They went to the dermatologist and he told them it could be attributed to him eating red meat. The reporter wanted to know what they should do for it. Investigation assessment was noted as no. The outcome of rash was not recovered and of shingles was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Herpes zoster', 'Rash']",1,PFIZER\BIONTECH, 1068157,FL,65.0,F,"Low-grade fever, chills, lethargy, muscle soreness; Low-grade fever, chills, lethargy, muscle soreness; Low-grade fever, chills, lethargy, muscle soreness; Low-grade fever, chills, lethargy, muscle soreness; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of bnt162b2 (BNT162B2 also reported as product COVID 19 brandPfizer, lot EL9265), via an unspecified route of administration in left arm on 30Jan2021 13:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included MAC (mycobacterium avium complex) and allergic to strawberries. She had her first dose of bnt162b2 (lot EL3246) on 09Jan2021 in the left arm. The patient's concomitant medications were not reported. The patient previously took rifampin and and experienced, both had drug allergy. On 31Jan2021 12:00, the patient experienced low-grade fever, chills, lethargy, muscle soreness with no treatment. The outcome of events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,01/31/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Fruit allergy; Mycobacterium avium complex infection,,,"['Chills', 'Lethargy', 'Myalgia', 'Pyrexia']",2,PFIZER\BIONTECH, 1068158,NY,64.0,F,"sore arm; mild headache; slight fever; swollen painful axillary lymph nodes; swollen painful axillary lymph nodes; This is a spontaneous report from a contactable healthcare professional. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) at the age of 64 years, via an unspecified route of administration on the left arm on 28Jan2021 14:30 at a single dose for COVID-19 immunization. Medical history included allergies, MVP (Mitral valve prolapse), HBP (High blood pressure) and thalassemia. The patient's concomitant medications were not reported. The patient is not pregnant. The patient previously received the first dose of BNT162B2 on 07Jan2021 (age at vaccination: 64 years), lot number: Ek9231 and experienced mild headache tiredness bruised arm not at injection site. On 29Jan2021, the patient experienced mild headache, slight fever and swollen painful axillary lymph nodes. The patient did not received treatment for the events. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date, COVID test: negative on 15May2020 and nasal swab: negative on 01Oct2020. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Allergic reaction (other medical history: Allergies mvp hbp thalassemia); Blood pressure high (other medical history: Allergies mvp hbp thalassemia); Mitral valve prolapse (other medical history: Allergies mvp hbp thalassemia); Thalassemia (other medical history: Allergies mvp hbp thalassemia),,,"['Blood test', 'Headache', 'Lymph node pain', 'Lymphadenopathy', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1068159,NJ,48.0,F,"mild tinging in her left arm; tingling in her feet; tingling in her feet and they also feel cold; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration on the left arm, on 31Jan2021 13:30, at single dose, for covid-19 immunization. Medical history included penicillin allergy. Concomitant medications included temazepam; spironolactone and; silybum marianum (MILK THISTLE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient received the vaccine in the hospital. It was reported that shortly after the vaccination, on 31Jan2021 the patient experienced mild tinging in her left arm that went away; but when she woke-up she noticed tingling in her feet and they also feel cold on 31Jan2021. The outcome of the event mild tingling in her left arm was recovered on 31Jan2021. The outcome of the events tingling in her feet and they also feel cold was unknown. The patient has not been COVID-tested post-vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/31/2021,01/31/2021,0.0,PVT,TEMAZEPAM; SPIRONOLACTONE; MILK THISTLE,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Paraesthesia', 'Peripheral coldness']",1,PFIZER\BIONTECH, 1068160,MA,67.0,F,"One and a half hours after vaccine shot, my mouth and face started to tingle. This continued for two hours.; One and a half hours after vaccine shot, my mouth and face started to tingle. This continued for two hours. The tingling spread to the skin on my chest. And briefly to my legs.; very light headed right after the shot; This is a spontaneous report from a contactable physician (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9261, expiry date: not reported), via an unspecified route of administration at left arm on 29Jan2021 12:45 at SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included arthritis, gastrooesophageal reflux disease (GERD), and migraine. The patient also had known allergies to multiple antibiotics, kiwi, walnuts, and bee sting. Concomitant medications included omeprazole (PROTONIX [OMEPRAZOLE]), topiramate, vitamin D3, guaifenesin (MUCINEX), and clarithromycin (CLARITIC). The patient stated, ""One and a half hours after vaccine shot, my mouth and face started to tingle. This continued for two hours. The tingling spread to the skin on my chest. And briefly to my legs. I had no trouble breathing. I was also very light headed right after the shot but that resolved quickly."" All the events started on 29Jan2021 14:15 (reported as 02:15 PM). There was no treatment received for all the events. The patient had no COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. On an unspecified date, the patient recovered from all the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,PUB,PROTONIX [OMEPRAZOLE]; TOPIRAMATE; VITAMIN D3; MUCINEX; CLARITIC,,Medical History/Concurrent Conditions: Allergy to antibiotic; Allergy to nuts; Arthritis; Bee sting hypersensitivity; Fruit allergy; GERD; Migraine,,,"['Dizziness', 'Paraesthesia', 'Paraesthesia oral']",UNK,PFIZER\BIONTECH, 1068161,MD,46.0,F,"Gait issue; involuntary lips movement; dizziness; fatigue; This is a spontaneous report received from a contactable pharmacist (who is also the patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the left arm, on 12Jan2021, at single dose, for COVID-19 immunization, at the hospital. The patient medical history was not reported. The patient has no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included levothyroxine and gabapentin. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown) received at age 46 years, via an unspecified route of administration on the left arm, on 24Dec2020, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 13Jan2021, the patient experienced gait issue, involuntary lips movement, dizziness and fatigue. No treatment was given for the events. The outcome of the events was not recovered. Information about lot/batch no. has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,PVT,LEVOTHYROXINE; GABAPENTIN,,,,,"['Dizziness', 'Dyskinesia', 'Fatigue', 'Gait disturbance']",2,PFIZER\BIONTECH, 1068162,,,U,"I had some terrible, terrible dizziness really, really bad; This is a spontaneous report from a contactable consumer (patient). A 91-year-old patient of an unspecified gender received the first dose of bnt162b2 (BNT162B2, lot number/batch and expiry date were not reported), via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history included hearing was not as good. The patient's concomitant medications were not reported. The patient informed of some terrible, terrible dizziness really, really bad on an unspecified date. The outcome of event was unknown. Information about Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Hearing impaired,,,['Dizziness'],1,PFIZER\BIONTECH, 1068163,NY,,U,"Sinus congestion; tachycardia; This is a spontaneous report from a contactable other healthcare professional (hcp reporting for self). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 29Jan2021 11:30 at a single dose in the left arm for COVID-19 immunization. Medical history included anxiety and seasonal allergies, both from an unknown date and unknown if ongoing. The patient had no Covid prior vaccination. Concomitant medications included mometasone furoate (FLONASE), escitalopram and unspecified daily multivitamin. Patient had no other vaccine in four weeks. The COVID-19 vaccine was administered in the hospital. On 30Jan2021 17:00, patient experienced sinus congestion and tachycardia. No treatments received in response to the events reported. Patient was not tested for covid post vaccination. The patient recovered in Jan2021 from the events sinus congestion and tachycardia. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,PVT,FLONASE; ESCITALOPRAM,,Medical History/Concurrent Conditions: Anxiety; Seasonal allergy,,,"['Sinus congestion', 'Tachycardia']",1,PFIZER\BIONTECH, 1068164,IN,50.0,F,"dizzy; nauseas; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer COVID vaccine), lot no. EL1283, via an unspecified route of administration (vaccine location: left arm) on 27Jan2021 10:00 at a single dose for COVID-19 immunization at a public health clinic/administration facility. Medical history included Gerd and allergies to tetracycline. Concomitant medications included omeprazole, cetirizine hydrochloride (ZYRTEC), ergocalciferol (VIT D), and unspecified multivitamins. No other vaccines in four weeks. No Covid prior vaccination. On 27Jan2021 10:00 AM (as reported), within 1 minute, the patient was dizzy and nauseas. The symptoms went away in10 minutes. No treatment for the events. She has not experienced any other side effects. No Covid test post vaccination. The outcome of the events was recovered on 27Jan2021 10:10.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,PUB,OMEPRAZOLE; ZYRTEC; VIT D,,Medical History/Concurrent Conditions: GERD,,,"['Dizziness', 'Nausea']",1,PFIZER\BIONTECH, 1068165,OR,32.0,F,"Cloudy; forgetful; entire right side of body sore; tingling; words jumbled, speech impediment; extreme dizziness; tachycardia; This is a spontaneous report from a contactable nurse (patient). This 32-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) intramuscularly on 01Jan2021 at 13:00 (at the age of 32-years-old) as a single dose in the right arm for COVID-19. The patient had no medical history and was not pregnant. The patient did not have COVID-19 prior to vaccination. The patient had no concomitant medications and did not receive any other vaccines within 4 weeks prior to the vaccine. The patient did not have any known allergies. On 01Jan2021 at 14:00, the patient experienced ""cloudy,"" forgetful, tachycardia, entire right side of body sore, tingling, words jumbled, speech impediment, and extreme dizziness. The patient did not receive any treatment for the events. The clinical outcome of ""cloudy,"" forgetful, tachycardia, entire right side of body sore, tingling, words jumbled, speech impediment, and extreme dizziness was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,SEN,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dizziness', 'Feeling abnormal', 'Memory impairment', 'Myalgia', 'Paraesthesia', 'Speech disorder', 'Tachycardia']",1,PFIZER\BIONTECH,OT 1068166,AR,77.0,F,"Ears are messed up; her ears are swollen on the inside; Running a temperature/low-grade fever; Headache; Nervousness; like a chronic ear ache; infection somewhere/earaches which turned out to be infected; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284; expiry date: unknown) , via an unspecified route of administration in the left arm, on 18Jan2021, at a single dose for COVID-19 immunisation. Medical history included ear problems in the past and sick. There were no concomitant medications. The patient had her first COVID shot on 18Jan2021. By Wednesday, two days later (20Jan2021), both ears were messed up, she was running a temperature (also reported as low-grade fever), had a headache, and was very nervous. She went to the doctor and her doctor gave her an antibiotic shot, two steroid shots, and some antibiotic ear drops, which did not work. She then did a home call with the doctor and she provided more steroids, an oral pack, and an oral antibiotic for 5 days. She was still having problems with her ears. Mainly her left ear. It goes from ear to ear. She went to the ENT about the earaches which turned out to be infected, and has subsequently been on two rounds of antibiotics, with persistent symptoms that have gotten better over time. Patient wanted to know if this could relate to the COVID Vaccine. She has never had this happen before, and she has been really sick but not this bad. She has had ear problems in the past, but normally the antibiotic liquid drops clear it up. It was like a chronic ear ache. Her earaches were hurting bad. What she is wondering is if it could be a side effect from the first COVID shot. She clarifies that her ears are swollen on the inside. It was an infection somewhere. The antibiotics and steroids have not healed it up. All of these events were still occurring but come and go. For instance, yesterday she had a low temperature but has not yet had one today. The antibiotic ear drops prescribed were Neopoly HC OTSC 1% OTIC SU. NDC: 24208-635-62. Expiry date: Jun2022. She was unsure what the lot was but also sees: 349111. The oral antibiotics she has is Amoxicillin 875mg/125mcg. These are in a pharmacy vial. Use before: 26Jan2022. She was given two steroid shots. One shorter acting and one longer acting. She was unsure of the names. Oral steroid pack: Manufactured by Pharmaceutical name. Prednisone USP 5mg. REV 1016. 314518. lot: 1150419. Expiry date: Feb2022. She also pre-treated with allergic reaction medications. She goes back to the ENT on Thursday. Patient wanted to know if these had happened to anyone before. Outcome of the event pyrexia was unknown, for events ear swelling, ear pain and ear infection was recovering, while for the other events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/18/2021,01/20/2021,2.0,UNK,,,Medical History/Concurrent Conditions: Ear disorder; Sickness,,,"['Ear infection', 'Ear pain', 'Ear swelling', 'Headache', 'Nervousness', 'Pyrexia']",1,PFIZER\BIONTECH, 1068167,MI,63.0,M,"Sore arm; Fatigue; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 63 years on 29Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue on 29Jan2021 (not sure if related) and sore arm on 30Jan2021. No treatment was received for the events. The outcome of the event was recovered on an unspecified date. Information on lot/batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,WRK,,,,,,"['Fatigue', 'Pain in extremity']",2,PFIZER\BIONTECH, 1068168,OH,41.0,F,"Fever last night of 102.3; cold chills; aches; extreme fatigue; loss of appetite; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 24Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included asthma. Concomitant medication included valaciclovir hydrochloride (VALTREX). The patient previously took acetylsalicylic acid (ASPIRIN) and hydrocododone and experienced allergies. The patient experienced cold chills and aches, extreme fatigue, loss of appetite on 26Jan2021 10:00 AM. At days 5-7, my symptoms went from to strongly moderate. Fever last night (30Jan2021) of 102.3. No treatment was received for the events. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/26/2021,2.0,UNK,VALTREX,,Medical History/Concurrent Conditions: Asthma,,,"['Body temperature', 'Chills', 'Decreased appetite', 'Fatigue', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 1068169,TN,43.0,F,"pupils were abnormally small/ Both pupils were constricted and fixed; Had a headache; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 29Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included migraines, endometriosis, allergic reaction to sulfa (both hives and skin flushing, elevated heartrate) and anaphylactic sting allergy. The patient is not pregnant. Concomitant medication included estradiol (VIVELLE DOT) and estradiol (IMVEXXY). The patient previously took codeine and experienced allergies (hives, skin flushing and elevated heart rate). It was reported that about 2 hours (reported as ""11:45"") after vaccination a coworker noticed that the patient's pupils were abnormally small for the lighting in the room. She had a headache as suggested with typical side effects. The patient took a picture. Both pupils were constricted and fixed. They have remained this way since that time. The patient have taken pictures periodically since it was noticed. The headache remains, but all other (typical) side effects have abated. No treatment was received for the events. The outcome of the event pupils were constricted was recovered on an unspecified date, while the event headache was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,UNK,VIVELLE DOT; IMVEXXY,,"Medical History/Concurrent Conditions: Allergy to sting; Endometriosis; Migraine; Sulfonamide allergy (both hives and skin flushing, elevated heartrate)",,,"['Headache', 'Miosis']",UNK,PFIZER\BIONTECH, 1068170,NY,,F,"The person who received the vaccine on 06Jan had low fever, muscle ache and headache the next day after the second dose.; The person who received the vaccine on 06Jan had low fever, muscle ache and headache the next day after the second dose.; The person who received the vaccine on 06Jan had low fever, muscle ache and headache the next day after the second dose.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of bnt162b2 for COVID-19 immunization on an unspecified date. On 07Jan2021, the patient who received the vaccine experienced low fever, muscle ache and headache the next day after the second dose. There was no treatment for the events. She had the antibody test on 29Jan2021 and was found negative. Outcome of events was recovered on an unspecified date. Information about Lot and Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/07/2021,1.0,UNK,,,,,,"['Headache', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 antibody test']",2,PFIZER\BIONTECH, 1068171,PA,56.0,M,"Mild palpitation; faint feeling; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received first single dose of BNT162B2 (Pfizer, lot number: EL0140, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 05Jan2021 for COVID-19 immunization. Facility type vaccine: Hospital. The patient's medical history and concomitant medications were not reported. The patient had no Covid prior to vaccination. On 05Jan2021, 30 min after injection, felt a mild palpitation-stronger than any previous mild ones but not as strong as the strong one he experienced after the first injection, and he had to close his eyes due to the faint feeling. This was followed by a mild one 3 min later. In the next few days, he had several additional mild to weak palpitations. The strong one that he experienced was 12-14 hours after receiving the first dose, did not show. The patient also experienced arm soreness after the first dose (Jan2021). The patient was not Covid tested post vaccination. The patient recovered from the events on an unspecified date in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/01/2021,,PVT,,,,,,"['Dizziness', 'Pain in extremity', 'Palpitations']",1,PFIZER\BIONTECH, 1068172,OR,,M,"Diarrhea; Stomach ache; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: L5318; expiration date not provided), via an unspecified route of administration (anatomical location: left arm) on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Patient has no medical history. Patient has no prior vaccination within 4 weeks and no AEs following prior vaccinations. There were no concomitant medications. The patient experienced diarrhea and stomach ache on 01Feb2021. Patient's clinical course is as follows: It was reported that reporter is a caretaker of the patient and mentioned that they both had the shot today (unspecified date). The reporter has taken the patient's temperature a couple times, the last time it was 98.6 (unit not specified). Reporter mentioned that patient was experiencing runny diarrhea and wants to know what to do about this. It was also reported that after getting the shot, around 12:30 (unspecified date), the patient started having the diarrhea. Patient also reported stomach ache that started around the same time. Patient never had diarrhea this long and like this before. It was reported that second dose is due on 22Feb2021. The patient underwent lab tests and procedures which included body temperature: 98.6. Outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,02/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No,,,"['Abdominal pain upper', 'Body temperature', 'Diarrhoea']",1,PFIZER\BIONTECH, 1068173,NC,66.0,F,"Raised, redness, swelling, tender at injection site; Raised, redness, swelling, tender at injection site; Raised, redness, swelling, tender at injection site; This is a spontaneous report from a contactable consumer (patient) reported that a 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on the left arm on 22Jan2021 11:45 at a single dose for Covid-19 immunization. The vaccine was administered at the workplace clinic. The patient medical history included allergic asthma, and had known allergies with penicillin both from an unknown date. Patient was not pregnant at the time of vaccination. Concomitant medication included melatonin taken from an unspecified date for an unspecified indication. On 30Jan2021 08:00, the patient experienced raised, redness, swelling, tender at injection site. As treatment, patient took Tylenol capsules. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/30/2021,8.0,WRK,MELATONIN,,Medical History/Concurrent Conditions: Allergic asthma; Penicillin allergy,,,"['Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 1068174,MS,71.0,M,"Spasm in the back of neck; difficult to sleep; This is a spontaneous report from a contactable consumer (reporting for himself). A 71-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on his left arm from 29Jan2021 11:40 to 29Jan2021 11:40 at SINGLE DOSE for COVID-19 immunization. The patient's medical history included cholesterol, gout, vitamin supplementation, and hypothyroid. Concomitant medication included simvastatin for cholesterol, allopurinol for gout, cinacalcet for hypothyroid. On 30Jan2021, the patient has a spasm in the back of his neck that makes it difficult to sleep and if you turn your head in any direction, you get a crook in your neck and it feels like someone is grabbing you by the back of neck. Therapeutic measures were taken as a result of spasm in the back of neck which included Tylenol Arthritis pain. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,PVT,SIMVASTIN; ALLOPURINOL; CINACALCET,,Medical History/Concurrent Conditions: Cholesterol; Gout; Hypothyroidism; Vitamin supplementation,,,"['Insomnia', 'Muscle spasms']",1,PFIZER\BIONTECH,OT 1068175,MA,31.0,F,"Change in menstrual cycle (period came 5 days early and was substantially lighter); body aches; Headache; chills/rigors; painful swollen axillary lymphnodes in affected arm, still swollen 3 weeks later; painful swollen axillary lymphnodes in affected arm, still swollen 3 weeks later; abdominal cramping; lightheadedness; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK4176, expiry date unknown), via an unspecified route of administration on 08Jan2021 at a single dose as a Covid vaccine. Medical history included allergies to penicillin. Prior to the vaccination, the patient has not had COVID-19. There were no concomitant medications. The patient did not receive other vaccines in four weeks or other medications in two weeks. The patient received the first dose of BNT162B2 (lot number: EH9899) on 18Dec2021 at 11:00 AM on the left arm as a Covid vaccine. The patient has not been tested for COVID-19 post vaccination. The patient experienced headache, chills, rigors, body aches, abdominal cramping, lightheadedness, painful swollen axillary lymphnodes in affected arm, still swollen 3 weeks later on 08Jan2021 at 11:00 PM. The patient also experienced a change in menstrual cycle (period came 5 days early and was substantially lighter) on an unspecified date in 2021. The patient did not receive treatment for the events. It was reported that the patient recovered from the events with lasting effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Abdominal pain', 'Chills', 'Dizziness', 'Headache', 'Lymph node pain', 'Lymphadenopathy', 'Menstrual disorder', 'Pain']",2,PFIZER\BIONTECH, 1068176,MN,57.0,F,"high fever 101 or something; her armpits and lymph nodes were very swollen.; her hand was kind of heavy; This is a spontaneous report from a contactable nurse (patient) reported that a 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on the left arm on 28Jan2021 at a single dose for Covid-19 immunization. The patient medical history included that she was diabetic, and she have had COVID and she have been in long term for COVID from Jul2020 and unknown if ongoing. Concomitant medication included metformin. The patient received the vaccine on Thursday morning (28Jan2021) and the next day (29Jan2021), her hand was kind of heavy and that night through Saturday (30Jan2021). On an unspecified date, the patient spike very high fever 101 (no unit reported) or something all through non-stop; her armpits and lymph nodes were very swollen. As treatment, patient took Tylenol for the events. The outcome of her hand was kind of heavy was recovered on 30Jan2021, high fever 101 or something was unknown, and armpits and lymph nodes were very swollen was not recovered. The patient stated that she would like to be tested for her immunity before receiving her second dose since she thought that she still have low immunity from Jul2020 because she have been in very long term of Covid.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,UNK,METFORMIN,Immune system disorder (still have low immunity from Jul2020 because she have been in very long term of Covid),Medical History/Concurrent Conditions: COVID-19 (still have low immunity from Jul2020 because she have been in very long term of Covid); Diabetic,,,"['Body temperature', 'Limb discomfort', 'Lymphadenopathy', 'Pyrexia']",1,PFIZER\BIONTECH, 1068177,OK,,M,"tested positive for covid virus; This is a spontaneous report from a contactable consumer(patient). This consumer reported similar events for 2 patients. This is the 1st of 2 reports. The 66-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9262), via an unspecified route of administration on 21Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included heart problems. The patient's concomitant medications were not reported. His First Dose was on 21Jan2021 at about 3PM. Then on either 23Jan2021 or 24Jan2021 he was diagnosed positive for covid. To test him they did a nasal swab up the nose, and in 15 minutes they gave him the result. His Antibody infusion treatment (in other words receive donated antibodies to help fight the virus) was either 25Jan2021 or 26Jan2021. It did help him big time, he was feeling great. He was scheduled for his second dose on 11Feb2021. Outcome of event was unknown. Case was assessed as non-serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021145989 same reporter/drug, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Heart disorder,,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068178,SC,34.0,F,"I had severe soreness for 2 days; I have a half of the dollar size, coin size of bump and it's been red and swollen and itchy; I have a half of the dollar size, coin size of bump and it's been red and swollen and itchy; I have a half of the dollar size, coin size of bump and it's been red and swollen and itchy; I have a half of the dollar size, coin size of bump and it's been red and swollen and itchy; This is a spontaneous report from a contactable pharmacist (patient). A 34-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL9264), via an unspecified route of administration at left deltoid on 28Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient reported that she had her vaccine last Thursday (28Jan2021) and believed she had an injection site reaction. She had severe soreness for 2 days and she had a half of the dollar size, coin size of bump and it's been red, swollen and itchy. She did not take anything for the events because she wanted to see how bad it goes. There was no Physician's Office/Emergency Room visit. She was curious if she will get the second dose since she had this first reaction. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Vaccination site erythema', 'Vaccination site mass', 'Vaccination site pain', 'Vaccination site pruritus', 'Vaccination site swelling']",UNK,PFIZER\BIONTECH, 1068179,,61.0,M,"A (Name)-Anti_SARS-CoV-2 S semi quantative immunoassay was done 20 days after the second injection revealing extremely low titers; This is a spontaneous report from a contactable physician (patient). A 61-year-old male patient received BNT162B2 second dose on unspecified date at single dose for COVID-19 immunization, first dose on unspecified date at single dose for COVID-19 immunization. Medical history included type 2 Diabetes. Concomitant medications were not reported. Patient received both doses of Pfizer COVID-19 Vaccine with no side effects. A semi quantative immunoassay was done 20 days after the second injection revealing extremely low titers. Result was 1.75 (positive range is 0.8 to 250). This result is much lower than expected. The concern is that one of the doses he received was ineffective due to unknown improper handling of the vaccine. Has Pfizer done any studies using this assay after vaccination? The only studies patient found for this assay was after infection. The outcome of the event was unknown. The seriousness was reported as no.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Type 2 diabetes mellitus,,,"['SARS-CoV-2 antibody test', 'SARS-CoV-2 antibody test positive']",2,PFIZER\BIONTECH, 1068180,,,M,"he tested positive for the Coronavirus; he tested positive for the Coronavirus; This is a spontaneous report from a contactable consumer reported for his father. An 89-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 at single dose for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. The patient received his first vaccine 3 weeks ago in Jan2021. Yesterday 09Feb2021 he tested positive for the Coronavirus. The reporter was trying to figure out how much protection does the patient had after receiving the first dose. He had probably been infected two or three days. He was trying to find out is the patient 50% protected, 65% protected, or 70% protected. Maybe he was not going to be as sick as a lot of people would be. The reporter asked how much was he protected from the first vaccine? He was wondering if he was protected some and it may increase his chance of surviving the virus. He stated that (domain name) stated that after 14 days the first dose of the vaccine was 52% effective and wanted to know if this is true and how much he is protected against the virus now that he has it. The reporter stated he was asking something very simple (about whether one dose of the vaccine would increase the chance of survival if getting Covid) and had the right to this information and should not have to check with a healthcare provider to get this information. The report was reported as non-serious. The outcome of the events was unknown. information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,02/09/2021,39.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068181,GA,63.0,F,"A little bit of soreness in arm injection was administered; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in eft arm on 14Jan2021 09:05 at a single dose for vaccination. There were no relevant medical history and concomitant medications. The patient previously received flu shot on Sep2020. The patient experienced a little soreness in arm injection was administered on 14Jan2021 and recovered completely from this event by the evening of 14Jan2021. She was feeling good. Described the event as very minor, minimal similar to what one might get with a flu or tetanus shot. Information on Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1068182,NY,73.0,M,"Not feeling well; Dizzy; Body pain all over his body; Cannot stand up; back pain; pain in arms; Issues with articulation; This is a spontaneous report from a two contactable consumers (patient reporting for himself and patient's son). A 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration on 29Jan2021 at SINGLE DOSE for an COVID-19 immunization, at 73-years-old. The patient medical history and concomitant medications were not reported. The patient experienced not feeling well, dizzy, pain all over his body, cannot stand up, back pain, pain in arms, issues with articulation on an unspecified date in 2021. Outcome of the events was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,,,UNK,,,,,,"['Back pain', 'Dizziness', 'Dysarthria', 'Dysstasia', 'Malaise', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 1068183,NY,,F,"Tested positive for COVID / she got COVID on an unspecified date; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. While reporting for herself, the reporter mentioned that she had a friend who was a pharmacist and she got the COVID vaccine and five days later, she got COVID on an unspecified date and she posted it on a social media. She said she must have been exposed before that. She did not have any additional details to report. Outcome of event was unknown. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1068184,FL,,F,"Upset stomach; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included cancer (She has had cancer like 3 times). It was reported that the patient had upset stomach on an unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Cancer (She has had cancer like 3 times.),,,['Abdominal discomfort'],UNK,PFIZER\BIONTECH, 1068185,IN,82.0,F,"nauseated; vomited and cannot keep anything down; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 30Jan2021 14:40 at a single dose for covid-19 immunisation. Medical history included diabetes mellitus diagnosed 40 years ago. There were no concomitant medications and no prior vaccinations within 4 weeks. The patient was nauseated and vomited and cannot keep anything down starting on 31Jan2021 to the date of report. Events did not require emergency room nor physician's office visit and no treatment was received. Outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/31/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Diabetes (diagnosed 40 years ago),,,"['Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH, 1068186,FL,76.0,F,"head hurt; pain in all of her joints/couldn't move fingers; felt numb; Nauseous; felt unstable; light-headed and dizzy; Sweating; Chills; seemed to not be able to register stuff, she wouldn't necessarily say memory loss, but she couldn't put stuff together; Not hearing correctly; not wanting to eat; She was beginning to feel dehydrated; shaking; equilibrium was off; sleeping for hours; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiry date: 31May2021), via an unspecified route of administration on 29Jan2021 (at the age of 76 years old) at a single dose for covid-19 immunization. Medical history included pre-diabetic, thyroid (disorder), and cholesterol (abnormal). Concomitant medications included levothyroxine from unspecified date to 31Jan2021 as thyroid medication and rosuvastatin for cholesterol. The patient previously took first dose of bnt162b2 (lot number: PFREL1283, expiry date: 30Apr2021) on 08Jan2021 (at the age of 76 years old) at a single dose for covid-19 immunization and experienced Injection arm pain, a little more drowsy than normal, and more tired. On 29Jan2021, the patient experienced sleeping for hours. On 30Jan2021, the patient experienced when she woke up, she thought she was headed for the emergency room (ER) as she had pain in all of her joints. At first, it was only her fingers which lasted for five minutes or so where she couldn't move her fingers, she felt numb, she was very nauseous. she couldn't hold down food, she never threw up though, she felt unstable. If she drank water, she would immediately be going to the bathroom, she was beginning to feel dehydrated. She just couldn't hold it when she had to go to the bathroom. Then, the finger pain went to her joints in her elbows and knees. On 30Jan2021, she was also light-headed and dizzy, she was not wanting to eat, she tried to eat dry toast. She was nauseous in her stomach, but she didn't throw up. She experienced sweating and chills. On late Saturday evening of 30Jan2021, she also had an issue, a very mild case, of not hearing correctly but it was not a ringing in her ear, it was like her equilibrium was off. She ended up putting a little bit of liquid ear drops in her right ear, and that seemed to help it. Right now she feels like she has recovered from everything. When unstable, it didn't seem to last too long, she is in bed most of the time. By the time she got up to eat, she was fine. But then she lapsed into chills and shaking. The patient also experienced she seemed to not be able to register stuff, she wouldn't necessarily say memory loss, but she couldn't put stuff together (30Jan2021). She can remember stuff now and it only lasted that day. On 31Jan2021, her head hurt. Therapeutic measure was taken as a result of the event a very mild case, of not hearing correctly. Outcome of events felt unstable, light-headed and dizzy, memory impairment was recovered on 30Jan2021. Outcome of the events arthralgia, felt numb, nauseous, head hurt, sweating, chills; not hearing correctly, not wanting to eat, dehydration, shaking and equilibrium was off was recovered on 31Jan2021. Outcome of event sleeping for hours was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,UNK,LEVOTHYROXINE; ROSUVASTATIN,,Medical History/Concurrent Conditions: Blood cholesterol abnormal; Pre-diabetic; Thyroid disorder,,,"['Arthralgia', 'Balance disorder', 'Chills', 'Dehydration', 'Dizziness', 'Eating disorder', 'Feeling abnormal', 'Headache', 'Hyperhidrosis', 'Hypersomnia', 'Hypoacusis', 'Hypoaesthesia', 'Memory impairment', 'Nausea', 'Tremor']",2,PFIZER\BIONTECH, 1068187,OH,77.0,F,"She has been able to eat, but nothing taste that great; had a day and a half of diarrhea; She is having chills occasionally; She feels totally exhausted; she has felt so stupid; she doesn't feel well enough; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), via an unspecified route of administration at left arm on 27Jan2021 13:50 at single dose for COVID-19 immunization. The patient received the vaccine due to her age and she was due for it. Medical history included fractured ankle. Pateint's height was five two and shrinking. She is on (networking site) with people she went to high school with and they are all getting the shot at same time because of their age. They were all saying they have had no side effects and no symptoms. There were no concomitant medications. The patient read the information they gave her after the shot. Now, she knows why she has felt so stupid. It was all the stuff on the list. On 28Jan2021 about 19:00, she had a day and a half of diarrhea and she was having chills occasionally. On 28Jan2021, she felt totally exhausted. A little bit of everything. She was not nauseous. On 29Jan2021, she has been able to eat, but nothing tasted that great. Even when her son got her what she wanted it still did not taste great. She is coming off a fractured ankle and she is going to have cancel therapy because she doesn't feel well enough to do that. She got the first vaccine on 27Jan2021. It will be a week on Wednesday. On Thursday and Friday she had diarrhea. Serious quantity of Pepto Bismol kept that at bay. The exhaustion has only improved a little. It was good for her to get up and move. No additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to Emergency Room or Physician Office. No prior vaccinations (within 4 weeks). The outcome of the event diarrhea was recovered on 29Jan2021; events chills and exhausted was recovering; event 'she has been able to eat, but nothing taste that great' was not recovered; and unknown outcome for the other events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Ankle fracture (.); Body height decreased,,,"['Chills', 'Diarrhoea', 'Fatigue', 'Feeling abnormal', 'Malaise', 'Taste disorder']",UNK,PFIZER\BIONTECH, 1068188,IN,79.0,M,"not been feeling well at all; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL9262, expiry date unknown), via an unspecified route of administration at the left arm on 29Jan2021 13:15 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he had an injection site pain on 29Jan2021. It was still sore after 3 days and the day afterwards he was not been feeling well at all on 30Jan2021. He was not sure if it has any effect on it, but had a pacemaker put on the right side of his chest in a week before getting the shot so he was not sure if that could affect how he was feeling. The outcome of the event 'injection site pain' was not recovered and the outcome of the event 'not been feeling well at all' was recovering. The vaccination facility type was hospital. The vaccine was not administered at the military facility.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,PVT,,,,,,"['Malaise', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 1068189,FL,75.0,M,"Headache; Vertigo; Dizziness; prescribed was meclizine/because of his Parkinson's medications she believes it interacted; Couldn't walk/ the medication (meclizine) really affected his walking and so forth; This is a spontaneous report from a contactable consumer reporting for a patient. A 75-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK4176), intramuscular on 12Jan2021, 11:00 at SINGLE DOSE for COVID-19 immunisation, at 75 years old; and started to receive meclizine (expiration date 20Jan2022) via oral route of administration from an unspecified date in 2021 at 25 mg, thrice daily for vertigo. Medical history included ongoing Parkinson's from 2011, and ongoing glaucoma from 2017. No other vaccines administered on the same date. No other vaccines within 4 weeks. The patient's concomitant medication included unspecified lots of medications for Parikinson's from an unspecified date. The patient experienced headache on 12Jan2021, on the first day; and vertigo on Jan2021 described as on the 4th or 5th day and dizziness on Jan2021. He slept in the chair for 5 days. He could not lay down without having vertigo. The vertigo has slowly gone away but now he is experiencing dizziness. When he tries to stand, he gets quite dizzy. Patient is due to receive his second vaccine tomorrow at the facility. Reporter wanted to know if patient should get the second vaccine. Patient still has very mild headaches off and on. The vertigo has gone away but he believes the dizziness has gotten a little worse. When he goes to stand up or anything, especially after laying down, he gets quite dizzy. They called the doctor's office and his doctor put him on a medication that was supposed to help with the vertigo. But, because of his Parkinson's medications she believes it interacted and did not work with him. He couldn't take it. He couldn't walk (unspecified date in 2021). She clarifies further the medication (meclizine) really affected his walking and so forth. The medication he was prescribed was Meclizine 25mg. He was prescribed to take one tablet by mouth three times daily as needed. She confirms the medication is dispensed in a pharmacy bottle. Patient wanted to know if there is any history of other people having dizziness and vertigo. The action taken for meclizine was unknown. Outcome of the event headache, Couldn't walk/ the medication really affected his walking and so forth, and ""prescribed was meclizine/because of his Parkinson's medications she believes it interacted and did not work"" was unknown. Outcome of dizziness was not recovered. Outcome of the event vertigo was recovered on an unspecified date in 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/01/2021,,UNK,MECLIZINE HCL,Glaucoma; Parkinson's disease,,,,"['Dizziness', 'Drug interaction', 'Gait inability', 'Headache', 'Vertigo']",1,PFIZER\BIONTECH,OT 1068190,MO,84.0,M,"Chills; fever and a temperature (unspecified); Tiredness; Weak; This is a spontaneous report from a contactable consumer. An 84-year-old male patient (reporter's husband) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262, expiry date unknown), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter and the patient got the vaccine and it was reported that the patient got side effects on 30Jan2021. The patient got lot of chills, had fever and a temperature (unspecified). The patient also had tiredness and was very weak. He had to go to the bed in the afternoon and that was 24 hours later. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/30/2021,1.0,UNK,,,,,,"['Asthenia', 'Body temperature', 'Chills', 'Fatigue', 'Pyrexia']",1,PFIZER\BIONTECH, 1068191,,,F,"blood in her mouth; metallic taste in her mouth; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced blood in her mouth and metallic taste in her mouth on an unspecified date. It was reported that the patient had a metallic taste in her mouth which she has a strong metallic taste but also has blood in her mouth. She wants to know if that is a side effect. She still has the metallic taste but no longer has blood in her mouth. The patient woke up with blood in her mouth. The patient recovered from blood in her mouth while not recovered from metallic taste in her mouth. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Dysgeusia', 'Mouth haemorrhage']",UNK,PFIZER\BIONTECH, 1068192,FL,76.0,F,"more tired; left arm/injection arm, had a little bit of pain; little more drowsy than normal; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: PFREL1283; expiry date: 30Apr2021) via an unspecified route of administration on 08Jan2021, at single dose, for COVID-19 immunization. Medical history included pre-diabetic, thyroid disorder and cholesterol abnormal. Concomitant medications included levothyroxine for couple of years for thyroid disorder and rosuvastatin for 30 some odd years for blood cholesterol abnormal. The patient reported that with the first shot, she had side effects she was aware of. On 08Jan2021, she was a little more drowsy than normal. It was nothing severe, but when she was up and awake, she could tell she was more tired. That lasted over 3 days. It wasn't like she couldn't do anything. She just felt more tired than normal. It was different than normal. On 09Jan2021, her left arm, which was her injection arm, had a little bit of pain. She understood that though. It lasted a couple of days. Outcome of the event tired was unknown, while for the other events was recovered on 10Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,LEVOTHYROXINE; ROSUVASTATIN,,Medical History/Concurrent Conditions: Blood cholesterol abnormal; Pre-diabetic; Thyroid disorder,,,"['Fatigue', 'Somnolence', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1068193,TX,68.0,F,"she has a cold sweat or something right now; She has not eaten anything.; her right arm felt like it was going to fall off it hurt so bad; she has ran a temperature and that finally broke but the highest was 102.4; She has been so weak she hasn't been out of bed hardly.; tired; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9265), via an unspecified route of administration from 29Jan2021 14:45 (2:45 PM) at single dose on right arm (as she was left handed) for COVID-19 immunization. Medical history included COVID (recovered) on an unspecified date. There were no concomitant medications. No additional vaccines administered on same date of Pfizer suspect. Patient previously got her flu and shingles shot at the end of ""October"". Patient took the vaccine last Friday (29Jan2021) at the age of 68 years old (reported as ""68 and a half""). She does not know if that makes a ""different"" but her right arm felt like it was going to fall off it hurt so bad, on a scale of 1-10 it was about a 20. It was really tender she put a heating pad on it, she has been sleeping on the heating pad and it was mild now. It was only about a 3 now and it has come down, but it hurt like the dickens. Also she has ran a temperature and that finally broke but the highest was 102.4. Patient has slept around the clock and she has not been out of bed but like 30 minutes out of the last 24 hours (hrs) just to go the potty or drink something. Patient stated ""almost gave up holding it was so long"". She has been so weak she has not been out of bed hardly. Patient said that she has eaten since, ""lets see Saturday night, Sunday, Monday"". Patient has not eaten since Saturday night (30Jan2021) or gotten out of bed. She has not eaten anything. Patient has had COVID and recovered so she did not want to catch that again. She confirmed that she had COVID prior to received the vaccine. She called her primary care and she has a viral phone call tomorrow or visual phone call, whatever its called, she was trying to get over this mess, she feels warm, she was not registering a temperature right now but she had a cold sweat or something right now (01Feb2021). Patient has a call with him tomorrow so he will know about this incase Pfizer calls. Patient stated that she knows with a normal vaccine she might have an ache or something but this one hurt bad, maybe they pushed it in too hard or something she does not know. When asked for vaccination facility type, the patient answered that they had a vaccine clinic they had set up there in a conference room, they had an elaborate set up, go through certain places and there were several steps. Vaccine was not administered at facility (reported as ""No hospital""). Patient further reported that her arm on 29Jan2021 (Friday evening) was tender. Patient lives by herself, she came home and does not know if she event ate. All she knows was she was real tired that Friday evening, it was tender and it got worse. Events did not require emergency room and physician room visit, reported as ""Not to date but tomorrow she does not know if he will have her come in unless she spikes another fever or if he will do anything she may just ride it out"". When asked for adverse events prior vaccinations, the patient answered ""no none that she can remember. Sometimes she will have a sore arm that is why she gets it in the right arm because she is left handed thinkin her dominant hand will not have any problems but this one hurt really bad. Have they had many calls where this is really effecting arms really bad?"". Patient also reported that her sister had the shot the same day and her arm was a little sore but that was all, she does not have NDC lot expiration for her sisters dose of the vaccine. She went to a different facility in a different location. Outcome of ""her right arm felt like it was going to fall off it hurt so bad"" was recovering, while for other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,PVT,,,Medical History/Concurrent Conditions: COVID-19 (recovered),,,"['Asthenia', 'Body temperature', 'Cold sweat', 'Eating disorder', 'Fatigue', 'Pain assessment', 'Pyrexia', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 1068194,,,F,"Chills; coldness; Heart was beating fast; Palpitations; Headache; Dizzy; Tired/exhausted/feeling of exhaustion; Breathing was not coming on easily; Slight muscle ache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the patient that after she got her vaccine, she was feeling fine. She did have chills and coldness. That was pretty much it. The nurse had asked if her heart was beating fast. She replied that it was, but she thought it was out of excitement or adrenaline. They said to let her doctor know if anything happens. She went home and Friday afternoon the chills were noticed more and her heart felt like it was beating faster. It was 100 beats per minute. She felt palpitations, chills, and headache coming on. The next morning, she felt much better than the night before. A little later that day she was getting tired, exhausted, and had a headache. The night before she felt a little dizzy too. Then the next day her breathing was not coming on easily. She also had a little muscle ache. Each day she is feeling better which is good. But the feeling of exhaustion is still there. The outcome of the event fatigue was not recovered while recovering for the other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,,,UNK,,,,,,"['Chills', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Feeling cold', 'Headache', 'Heart rate', 'Heart rate increased', 'Myalgia', 'Palpitations']",1,PFIZER\BIONTECH, 1068195,AR,83.0,M,"The pains across his body keeps getting worse, the pains got a little better Saturday but then Saturday night it got pretty bad.; Loss of taste; difficulty talking; Friday night the same thing happened except the pains were a little higher and above his belly button; pain across body; little bit of soreness in left arm; This is a spontaneous report from a contactable consumer (patient). This 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EL9261, exp. unknown) , intramuscular on left arm on 21Jan2021 08:30 at single dose covid-19 immunization at a clinic. Medical history included thyroid disorder from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine 100mcg once a day for thyroid. The patient experienced little bit of soreness in left arm (non-serious) on 21Jan2021 with outcome of recovered, pain across body (non-serious) on 28Jan2021 20:00 with outcome of recovering , the pains across his body keeps getting worse/the pains got a little better Saturday but then Saturday night it got pretty bad (condition aggravated) (non-serious) on an unspecified date with outcome of unknown, loss of taste (non-serious) on 01Feb2021 with outcome of unknown, difficulty talking (non-serious) on 31Jan2021 with outcome of not recovered , pains were a little higher and above his belly button (non-serious) on 29Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included thyroid function test was low on Sep2020 (levothyroxine was changed to 125mcg from 112mcg), thyroid function test was back towards normal but had not quite reached it on Nov2020 (new dose of 100mcg tablet once a day), thyroid function test was unknown on 25Jan2021 but was on 100mcg of levothyroxine once a day. Therapeutic measures were taken as a result of little bit of soreness in left arm and pain across body included Tylelol (acetaminophen).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,OTH,LEVOTHYROXINE,,Medical History/Concurrent Conditions: Thyroid disorder (Verbatim: thyroid),,,"['Abdominal pain lower', 'Ageusia', 'Condition aggravated', 'Pain', 'Pain in extremity', 'Speech disorder', 'Thyroid function test']",UNK,PFIZER\BIONTECH,OT 1068196,IN,74.0,F,"Bad headache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL8920, expiry date unknown), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. Medical history included COVID from Nov2020 to an unknown date. The patient's concomitant medications were not reported. The patient stated that she had a very slight case of COVID in Nov2020 and her family doctor told her about three weeks ago that she needed to get the vaccine. However, he did not tell the patient that she needed to wait 90 days from when she had COVID (as reported). So, she got the Pfizer vaccine about two months and a week after she had COVID itself. Ever since about five days after she had the vaccine, on an unspecified date in Jan2021, she came down with a bad headache and have had a headache since that day. She is on day nine of a headache and this is the headache that require medication. It is not the headache that you think is going way because it has not. She wanted to know if she got the headache because she got the vaccine too soon after having COVID. The patient got medicine for the headache because she had to go to the emergency room for the event. She had blood work done on an unspecified date but had unknown results. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,01/01/2021,,PVT,,,Medical History/Concurrent Conditions: COVID-19,,,"['Blood test', 'Headache']",1,PFIZER\BIONTECH, 1068197,,,F,"Migraines came full blown; Excruciating headaches; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (reported as Age: 39, Unit: Unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Family history includes her mom having history of migraines. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Dec2020 for COVID-19 immunization and experienced Tingling, throbbing, and pressure on the top and back of her head. The patient received the second of the vaccine on 15Jan2021 and stated the migraines came full blown on an unspecified date in 2021. She also reported experiencing excruciating headaches on an unspecified date in 2021, in which she called off work today and has visited urgent care. The patient stated that she does not have a history of migraines. She wanted to know the percentages of people who have experienced headaches in both age groups. She also stated that her mom has a history of migraines. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,,,UNK,,,Medical History/Concurrent Conditions: Migraine (Her mom has a history of migraines),,,"['Headache', 'Migraine']",2,PFIZER\BIONTECH, 1068198,TX,,F,"arm was a little sore; This is a spontaneous report from a contactable consumer (patient's sister). A female patient of unspecified age received BNT162B2 (COVID vaccine), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had the COVID vaccine and her arm was a little sore but that's all. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain in extremity'],UNK,PFIZER\BIONTECH, 1068199,MD,72.0,M,"low grade temp; soreness in arm; feeling achy; feeling weak; felt like a bad cold; chills; threw up in his sleep; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient started to received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date unknown), via an unspecified route of administration at the left arm on 29Jan2021 14:35 at a single dose for COVID-19 immunization. The patient's medical history included to go to sleep, opens up the prostate and prostate cancer. The patient's family history included prostate cancer (father and brother). The patient's concomitant medications included ongoing tamsulosin to opens up the prostate and plantago ovata (METAMUCIL). After the vaccine, patient felt fine on Saturday and Sunday then last night (31Jan20201) he threw up in his sleep, it startled him and woke him up. Then he got up again at 0600AM on 01Feb2021 to take a leak and reported feeling achy; weak feeling like he had a bad cold; and he took his temperature which was 96.9 (unit unknown) which seems normal for him. He took it again and it was 98.4 (unit unknown). The patient reported that he was fine for 2 days then felt the effects. He threw up in middle of night, achy weakness, chills, low grade temp. He had soreness in arm on an unspecified date. The guy that gave the shot said his arm got sore for about 24hrs and the patient took Tylenol. Patient was asking if he should be concerned the symptoms started more than 36hours after getting the 1st dose. He was asking if these can be reaction to vaccine or if he needs to get tested for COVID.He was scheduled to receive the second dose on 20Feb2021. The outcome of the event 'threw up in his sleep' was recovered on 31Jan2021; feeling achy, feeling weak, felt like a bad cold, and chills were recovering; and the outcome of the other events was unknown. The vaccination facility type was hospital. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/31/2021,2.0,PVT,TAMSULOSIN; METAMUCIL [PLANTAGO OVATA],,Medical History/Concurrent Conditions: Prostate cancer (father and brother); Prostate cancer; Prostate surgery; Sleep disorder,,,"['Asthenia', 'Body temperature', 'Chills', 'Nasopharyngitis', 'Pain', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH, 1068200,,24.0,U,"A few days later I got covid; A few days later I got covid; This is a spontaneous report from a contactable consumer (patient). A 24-year-old patient of an unspecified gender received the first dose of bnt162b2 (BNT162B2, lot number unknown), via an unspecified route of administration (at the age of 24-years-old) on 19Jan2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated ""I got the vaccine (Unspecified Vaccine) on 19Jan (complete date not clarified); and then a few days later (in 2021) I got COVID and my mom also got COVID so I was wondering do I still; can I still get the second vaccine and how long should I wait from having covid to get the second vaccine?"" The outcome of the events was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1068201,CO,70.0,M,"not a lot of energy/little lack of energy; kind of numb; kind of sick; chills; light or mild fever; sweating; stomach cramps; felt like he had to throw up and couldn't; face did feel flushed; received first dose of BNT162B2/compromised immune status; received first dose of BNT162B2/compromised immune status; not been eating a lot since he got the vaccine/whole lot for that day and a half after the vaccine; Real tired; felt weak; right arm was sore/received first dose of BNT162B2; at the right arm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL9264 and expiry date unknown, via unspecified route of administration at the right arm on 29Jan2021 11:30 at single dose for Covid-19 immunization in a clinic (vaccination clinic at county government center) and not received in a military facility. Medical history included ongoing borderline diabetic (watch what he eats and do a little exercise and stuff couple years ago), overweight (probably 10 lbs), cholesterol (abnormal), diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity which was probably 10 lbs overweight. The patient was told that he has borderline diabetic watch what he eats and do a little exercise and stuff couple years ago. Concomitant medication included pravastatin from Aug2020 and ongoing for cholesterol. The patient did not receive other vaccinations within four weeks prior to the administration date of the suspect vaccine. On 29Jan2021 after the vaccine was administered, the patient was real tired, kind of felt weak and right arm was sore which he expected. The patient went to bed early about 20:30 and slept solid until 30Jan2021 07:00; like he did not know anything was going on while he slept. On 30Jan2021, he got up and he wasn't really tired, but he was really kind of numb, like he could not get his faculties together. The patient informed that after about 3 cups of coffee later that day on 30Jan2021, he got kind of sick in afternoon. The patient was really tired, had chills, thinks he had a light or mild fever, was sweating, had some pretty good stomach cramps that felt like he had to throw up and couldn't which lasted about 4 hours (30Jan2021). The patient's face did feel flushed a little bit on 30Jan2021. The patient thought he would have to go to the hospital for a time, but he waited it out and got better. The patient went to bed again early that day. On 31Jan2021, the patient felt better, but again not a lot of energy (pending clarification, also reported date 30-MAR-1871) probably because he had not been eating a lot since he got the vaccine on 29Jan2021. The patient still has a little lack of energy yet, but that could be because he did not eat a whole lot for that day and a half after the vaccine. The patient informed that he had no swelling in his arm or anything, he was thinking that he survived. The patient was back to feeling pretty good again today. The patient thought that the vaccine was going to work. The events did not require emergency room/physician visit. The patient did not provide information with the primary/prescriber. The patient's second dose was on 19Feb2021. The outcome of the events stomach cramps, felt like he had to throw up and couldn't was recovered on 30Jan2021, not a lot of energy/little lack of energy, not been eating a lot since he got the vaccine/whole lot for that day and a half after the vaccine was recovering, while unknown for the rest of the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,OTH,PRAVASTATIN,Diabetes mellitus,Medical History/Concurrent Conditions: Allergy (diagnosed); Blood cholesterol abnormal; Endocrine disorder; Gene mutation; Immune system disorder; Obesity; Overweight (probably 10 lbs); Respiratory disorder,,,"['Abdominal pain upper', 'Asthenia', 'Chills', 'Decreased appetite', 'Fatigue', 'Flushing', 'Hyperhidrosis', 'Hypoaesthesia', 'Illness', 'Nausea', 'Off label use', 'Product use issue', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1068202,MO,69.0,M,"can't see straight; dizzy; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264 and expiration date not provided), via an unspecified route of administration first dose on 29Jan2021 at single dose for Covid-19 immunization. The patient's medical history included ongoing high blood pressure. The patient's concomitant medications included unspecified blood pressure medication. It was reported that patient had first shot on Friday 29Jan2021 and everything was fine, it was the easiest shot has ever had. On Sunday 31Jan2021, the patient started getting dizzy. The patient had to hold on to the wall to balance himself. The patient was dizzy again today. The patient doesn't know if it is a coincident or a side effect. It probably started about 40 hours after the vaccine. The patient stated that he was currently miles from home, and he was going to start driving, but he can't see straight. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/31/2021,2.0,UNK,,Blood pressure high,,,,"['Dizziness', 'Visual field defect']",1,PFIZER\BIONTECH, 1068203,NE,,M,"arm was sore at the place/soreness in the arm around his injection site; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 31Jan2021 14:15 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient got the shot on 31Jan2021 at 1415 and everything was fine and it didn't hurt at all. Then this morning (01Feb2021) at 0600 - 0700 AM, he noticed his arm was sore at the place, also reported as soreness in the arm around his injection site. He was asking if he can take anything. He mentioned he has a bottle of acetaminophen and was asking if he can take it. The outcome of the event was unknown. Information on about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/31/2021,02/01/2021,1.0,UNK,,,,,,['Vaccination site pain'],UNK,PFIZER\BIONTECH, 1068205,CT,84.0,F,"Itchy nose; Sneezing; sore arm; Swollen face; This is a spontaneous report from a contactable consumer. An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) at age 84 years (as reported), via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing blood pressure high. Concomitant medication included warfarin sodium (COUMADIN). The patient previously received shingles vaccine (believes it was more than four weeks before getting the COVID vaccine). It was reported that the day after (26Jan2021), the patient experienced sore arm like everyone else. The sore arm has gone away, but does not know what day it went away. The day after the vaccine the patient had a swollen face (26Jan2021) and today it is worse; it is more swollen. On 01Feb2021, the patient experienced an itchy nose and sneezing. The outcome of the event sore arm was recovered on an unspecified date, the event swollen face was not recovered, while unknown for the events itchy nose and sneezing. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,OTH,COUMADIN,Blood pressure high,,,,"['Nasal pruritus', 'Pain in extremity', 'Sneezing', 'Swelling face']",1,PFIZER\BIONTECH, 1068206,IL,54.0,F,"Tested positive for Covid; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiry date: Apr2021), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient stated, ""I received the vaccine on 20Jan2021, Pfizer at my work at (Facility name) and then I just tested positive for COVID on 20Jan2021. So, how will that effect my second dose?"" When asked about treatment, the patient stated, ""I do not know. Is Tylenol also considered as a treatment?"" And when asked about causality, the patient stated, ""I think so, I mean I do not want to rule that out, but maybe."" The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/20/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1068207,GA,74.0,F,"Fever; Chills; Aches and pains; hurting all over; Headache like my head was going to explode; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3302; expiration date: unknown) at vaccination age of 74-year-old via an unspecified route of administration on 19Jan2021 at a single dose for covid-19 immunization. Medical history included type 2 diabetes, autoimmune thyroid disease and complex migraine (migraine chronic, complex migraine). The patient's concomitant medications were not reported. The patient reported that last Friday (29Jan2021, also reported as two weeks later), she got a fever, chills, aches and pains. She was hurting all over and she had a headache like her head was going to explode. So, she wanted to know could that be a delayed reaction to the shot (vaccine). The patient mentioned that treatment for the problems included acetaminophen, butalbital, and caffeine (FIORICET). The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,01/29/2021,10.0,UNK,,,"Medical History/Concurrent Conditions: Autoimmune thyroiditis; Migraine (have migraine chronic, complex migraine); Type 2 diabetes mellitus",,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 1068210,MI,84.0,F,"terrible pain in leg and can hardly walk; terrible pain in leg and can hardly walk; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown, reported as EL926S or EL9265), intramuscular (arm right) on 29Jan2021 at SINGLE DOSE for COVID-19 immunisation, at 84 years old. The patient's medical history included ""nerve pain, neuropathy"". Family history included Parkinson's (child). The patient previously received the first dose (arm left) of BNT162B2 (lot number ELO140) on 07Jan2021 for COVID-19 immunisation and experienced Slept the whole day. Concomitant medication included pregabalin (LYRICA) from an unspecified date for ""nerve pain, neuropathy"". No other vaccines were given the same day. It was reported that for COVID vaccine, there was a terrible pain in leg and can hardly walk on 30Jan2021. The pain in the legs was reported as getting worse. The adverse events did not require visit to the Emergency Room or Physician Office. Outcome of the event was not recovered. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,PUB,LYRICA,,Medical History/Concurrent Conditions: Neuropathy; Parkinson's disease (child),,,"['Gait disturbance', 'Pain in extremity']",2,PFIZER\BIONTECH,OT 1068212,,,F,"chills; low grade temperature; positive for COVID-19; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. Medical history included COVID-19 from Apr2020. Concomitant medications were not reported. On 29Jan2019, the patient tested positive for Covid-19. She reported that on 30Jan2021 she did not go to work because she had onset of the same symptoms that she experienced with COVID-19 in Apr2020, which were chills, low grade temperature that was not that bad, except for shortness of breath. She did not have shortness of breath this time. She felt like she had COVID-19 all over again starting 30Jan2021. On 31Jan2021, around 14:00, sehe reported that everything subsided, all the symptoms of COVID-19 stopped and were gone now, she has no symptoms. She was not allowed to work due to the COVID-19 positive result. The outcome of the events chills and low grade temperature was recovered on an unspecified date. The outcome of the event Covid-19 was unknown. Information about Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['COVID-19', 'Chills', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068214,IN,71.0,F,"could not get her legs to work; her arm was sore; Dizzy/ Dizziness was reported as worsened; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN5318) intramuscular on the right arm on 27Jan2021 15:30 at a single dose for COVID-19 immunization. Medical history included peritoneal dialysis from Apr2020 and diabetes (diagnosed about 30 years ago) both ongoing; blood thinner, 2 stents a and a balloon from Dec2020 and high blood sugar. There was no family medical history. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) for stents, insulin detemir (LEVEMIR) for diabetes, insulin aspart (NOVOLOG) for high blood sugar during the day and clopidogrel bisulfate (PLAVIX) as blood thinner all were ongoing. The patient stated that her arm was sore on 27Jan2021 and that was no big deal. She said that she got so dizzy and was walking like a drunk. Dizziness was reported as worsened. Patient said that last night (31Jan2021) she tried to get to the bathroom, but she could not get her legs to work. She said that her husband had to lead her to the bathroom with a walker and when she was done, she could not get back to bed. She was scared to death last night when her legs would not work. She said that she thought her symptoms would just go away. What should she do about her symptoms? The facility where the vaccine was administered was in a clinic. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to physician office or Emergency Room. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No relevant tests done. Outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,OTH,BABY ASPIRIN; LEVEMIR; NOVOLOG; PLAVIX,Diabetes (diagnosed about 30 years ago); Peritoneal dialysis,Medical History/Concurrent Conditions: Angioplasty; Anticoagulant therapy; Hyperglycemia; Stent placement,,,"['Dizziness', 'Gait disturbance', 'Pain in extremity']",UNK,PFIZER\BIONTECH,OT 1068218,TX,79.0,M,"a little bit of itching; kind of hives; uncomfortable at times, at his feet, and ankles; he has rashes; terrible skin; This is a spontaneous report from a contactable consumer (reporting for himself). A 79-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: unknown), via an unspecified route of administration from 09Jan2021 to 09Jan2021 at single dose for COVID-19 immunization. The patient's medical history Ablation surgery. The patient's concomitant medications were not reported. On an unspecified date, the patient had a little bit of itching, kind of hives, he did not break out, he was uncomfortable at times, at his feet, and ankles. The patient has rashes, and terrible skin. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/09/2021,,,UNK,,,Medical History/Concurrent Conditions: Radiofrequency ablation,,,"['Discomfort', 'Pruritus', 'Rash', 'Skin disorder', 'Urticaria']",1,PFIZER\BIONTECH, 1068219,IL,72.0,F,"Has a small, walnut sized lump on her left arm where the injection was; having increased arthritis pain; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (lot EL3247) via an unspecified route of administration in the left arm on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included Covid prior to getting the first shot (has had Covid). Concomitant medications were not reported. It was reported that the patient has a small, walnut sized lump on her left arm where the injection was on Jan2021 that has been there for about a week. She wanted to know what to do about the lump and if she should get the second shot. It was also reported that she's having increased arthritis pain on 2021. She's going to a state on 28Feb2021 and would have second shot on 23Feb2021 and she needed a negative Covid test 72 hours prior to going. She wanted to know how would she get a negative Covid test. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: COVID-19 (had Covid prior to getting the first shot),,,"['Arthralgia', 'Vaccination site mass']",1,PFIZER\BIONTECH, 1068221,,,U,"got upset; pulse faster than normal; Nervous; Worried; This is a spontaneous report from a non-contactable consumer (patient). An 80-year-old patient of an unspecified gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: Unknown), via an unspecified route of administration on 2021 at a single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medication included rosuvastatin calcium (CRESTOR) and unspecified blood pressure medication (the patient takes 40 mg and then with that, the doctor gave patient, it started with Hydro something and that kind of eliminate the salts from your body when you urinate a little bit more). The patient has hypertension and got upset and had a pulse faster than normal. The patient pulled over the vehicle and drive through and 'drive a mile' but then in about 10 minutes it started again but it seems like a 'fall down' and the patient got real nervous and patient was still nervous. The patient is 80 years old. The patient said he/she did not know he/she got home and the patient took a Benadryl as treatment. The patient got home, nervous and can breath all right, just nervous. The patient mentioned being in good health and everything and was just worried about himself/herself. The outcome of the event pulse faster than normal was recovering; nervous was not recovered; outcome for all other events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,CRESTOR,,Medical History/Concurrent Conditions: Hypertension,,,"['Anxiety', 'Emotional disorder', 'Heart rate', 'Heart rate increased', 'Nervousness']",UNK,PFIZER\BIONTECH, 1068224,FL,71.0,F,"Nauseous; Weak; Really unwell; Tired; Muscle aches; Headache; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: CN5318, via an unspecified route of administration at right arm on 29Jan2021 09:00 at a single dose for COVID-19 immunisation. Medical history was not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date. There were no concomitant medications. On 29Jan2021, at 7 pm, the patient was nauseous and weak. At 9 pm, the patient was really unwell, tired, headache, muscle aches and nausea. She slept all Friday night, all day Saturday. Late around Sunday was finally able to get out of bed. Asked if she should see a doctor. The patient was still nauseous and weak. The outcome of the events nausea and weak was not recovered. The outcome of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,UNK,,,,,,"['Asthenia', 'Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH, 1068228,NJ,24.0,M,"slight soreness; This is a spontaneous report from a contactable healthcare professional (patient). This 24-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3249) intramuscularly in the right arm on 19Jan2021 at 19:00 (at the age of 24-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient previously received the first dose of BNT162B2 (lot number EK9231) intramuscularly in the right arm on 29Dec2020 at 18:45. On 20Jan2021 the patient experienced slight soreness. No treatment was provided for the event. The clinical outcome of slight soreness was recovered on an unspecified date. It was also reported the patient was not tested for COVID-19 post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/20/2021,1.0,PVT,,,Medical History/Concurrent Conditions: COVID-19 (If COVID prior vaccination Yes),,,['Pain'],2,PFIZER\BIONTECH,OT 1068229,TX,,F,tested positive after taking the vaccine; tested positive after taking the vaccine; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was tested positive after taking the vaccine on an unspecified date in 2021. She wanted to know if she will continue with the second dose which is on 24Feb2021. Lab data included: COVID-19 tested positive in 2021. Outcome of the event was unknown. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068232,FL,61.0,F,"rash on neck; felt a little off, it could have been in her head or maybe was paranoid, but wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL; developed a bad rash, hives, all over her body; developed a bad rash, hives, all over her body; itching; a few bumps kept increasing up to 3 days later; her feet were incredibly hot over the next 3 days; arm soreness; She was unable to sleep from being so itchy; Allergic reaction; This is a spontaneous report from a contactable consumer herself. A 61-year-old female patient received bnt162b2 (, Solution for injection, Batch/lot no: EN5318), via an unspecified route of administration on 04Feb2021 15:00 in the left arm at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously did get a flu shot in Nov or Dec2020. The patient developed a bad rash, hives, all over her body and itching on 10Feb2021. She reports, her feet were incredibly hot over the next 3 days on 07Feb2021. What started off as a few bumps kept increasing up to 3 days later. She was unable to sleep from being so itchy. Her doctor said it was an allergic reaction and prescribed an antihistamine after which it left in Feb2021. She was due for the 2nd dose of the vaccine on 25Feb2021. The patient did not had any investigation assessment. The patient states that there was little information out there to compare the experience she had. Wanted to call to make Pfizer aware of that and maybe get some more information out there. Has printed out the fact sheet and assumes she should not get the second vaccine because of what happened the first time. Wants to clarify what happened and share with Pfizer this information since she can't find much information for people who have had a delayed reaction. Went to get the vaccine on 04Feb and doesn't consider herself an allergic type person. Has no allergy to foods, medicines, only gets poison ivy and bug bites like most people. By Monday, the 4th day (08Feb2021) after getting the vaccine, noticed a couple of bumps on the wrist and does not know where else and didn't think of it as anything else. Thought it was a bite or she touched a plant and then it went away. It was not much. In the evening of Tuesday she had a bad reaction and on the 10th (10Feb2021) she had rash, hives, and itching that just moved to different places over the body. Her feet were so hot on the 3rd day and had to plunged them into cold water and used Epsom salt off and on and it helped some. This happened only for 2 nights and the reason she didn't go to the doctor, it went away. Again, mentions the first night she had a couple bumps and didn't think much about it. The second night, it was all over her body, the rash, and she took Epsom baths that helped, but she didn't get much more than an hour of sleep. She tried to take pictures of her thighs and backside, but unable to take good pictures, not a selfie person. The next morning she had her husband take pictures in case it went away and she went to the doctor they would have pictures to show. Her husband thought it may be shingles. Called the doctor on Thursday and had pictures to show her since the rash went away. Again, mentions the reaction was so bad on Wednesday. The doctor didn't believe areas on pictures of her back were shingles since shingles does not come and go away like that and that she must have had an allergic reaction to something. Provider didn't believe it was from the vaccine. Was given a prescription for Hydroxyzine HCL 25mg and was informed if areas didn't improve or returned she may need to see an allergist or immunologist. After the appointment she didn't get much sleep and woke up at 4pm in the afternoon and felt a little off, it could have been in her head or maybe she was paranoid, but she wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL and went to bed at 7:30pm and didn't do anything since. Got up and the reaction/rash, hives, itching was all gone after taking only one. It's like an antihistamine or Zyrtec. No further details provided. Later mentions after getting the first vaccine on the 4th, the next day she had arm soreness up until that Monday when the rash started. No further details provided. Says as far as recommendations were concerned for the paper she printed, the fact sheet. It says pretty much listed, she shouldn't have the second dose if difficulty breathing, swelling in the face and throat. The only thing she had was the rash on the neck, not the face. Paperwork also lists heart beating fast, or severe allergic reaction. The patient had no emergency room visit. The patient visited the physician office. The outcome of the event hot feeling in feet was recovered on feb2021 and rest of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/01/2021,,SEN,,,,,,"['Feeling abnormal', 'Feeling hot', 'Hypersensitivity', 'Insomnia', 'Mass', 'Pain in extremity', 'Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH, 1068233,,,F,"increased blood pressure; spiked heart rate; nausea; dizziness almost to the point of fainting; dizziness almost to the point of fainting; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter wants to know if it is recommended for her to get the second dose of the bnt162b2 after she has experienced side effects from the first dose. The patient stated that she had increased blood pressure, spiked heart rate, nausea, dizziness almost to the point of fainting that the patient ended up in the emergency room. The patient also wanted to know if she has to wait some time before she gets the second dose and how long she can wait. The patient queried does she have to start over if she waits longer than the recommended period? The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Blood pressure increased', 'Blood pressure measurement', 'Dizziness', 'Heart rate', 'Heart rate increased', 'Nausea', 'Presyncope']",1,PFIZER\BIONTECH, 1068234,WA,75.0,F,"it showed a ""CRP value"" of 11.5 which is usually below 0.29 which shows inflammation; loss of appetite; Nausea; breathing problems; mild fever; Muscle ache; Joint ache; Rapid heart rate up to 130; Itchy skin; roof of mouth itching; eyes were also really sore; This is a spontaneous report from a contactable Other HCP (patient). A 75-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6201), via an unspecified route of administration in the right arm on 11Feb2021 at single dose for COVID-19 immunisation. Medical history included ongoing asthma initially diagnosed at 21 years old, ongoing arthritis diagnosed 10-15 years before but she thinks she had it since she was 35, multiple joint replacements, past pneumonia. The patient's concomitant medications were not reported. The patient previously received methotrexate 25mg a week orally for arthritis but she quit taking it about 3 months before in preparation of getting the vaccine. The patient previously received the first dose of bnt162b2 on unspecified date (lot EL8982) at single dose for COVID-19 immunisation in the right arm. The patient experienced mild fever on 12Feb2021 with outcome of recovered on 14Feb2021, roof of mouth itching on 11Feb2021 with outcome of recovered on 11Feb2021, muscle ache on 12Feb2021 with outcome of recovered on 12Feb2021, joint ache on 12Feb2021 with outcome of recovering, breathing problems on 12Feb2021 with outcome of recovering, rapid heart rate up to 130 on 12Feb2021 with outcome of recovering, itchy skin on 11Feb2021 with outcome of recovered on 11Feb2021, it showed a ""crp value"" of 11.5 which is usually below 0.29 on 15Feb2021 with outcome of unknown, nausea on 12Feb2021 with outcome of recovered on 13Feb2021, loss of appetite on 13Feb2021 with outcome of recovered on 13Feb2021, eyes were also really sore on 11Feb2021 with outcome of recovered on 15Feb2021. An EKG performed on 15Feb2021 as pending results. The event of breathing problems was serious due to disability. The events mild fever, roof of mouth itching, muscle ache, joint ache, rapid heart rate up to 130 and itchy skin were medically significant. The patient reported that initially, the roof of her mouth started itching. It literally happened as soon as she had the vaccine. She took a Benadryl. She didn't have a skin irruption, but did have itchy skin. The next day, she had a low grade fever. She had muscle and joint aches. She had no rash, but a little nausea. She had breathing problems. She had asthma issues and wheezing after the vaccine. That is how she described her breathing issues. She had a rapid heart rate. It went up to 130. It could of been because of fever, her breathing, or pain. There was a period of days then it resolved. On 15Feb2021, she feels almost human. She had routine arthritis lab drawn on 15Feb2021. They showed a CRP level of 11.5 which shows inflammation. She normally was below 0.29 which was within normal limits. That was an extreme difference. That was a lot of inflammation. The patient had to get her nebulizer out to breathe. She has taken Tylenol a couple of times. Her lab work was essentially normal. The CBC and chemical panel was okay. The patient thoughts the fever was important because she has been immunocompromised for years by Methotrexate. She has had pneumonia before with no fevers. Her eyes were also really sore. They bothered her. She already had to use eye drops. That was 11Feb2021 it was gone on 15Feb2021 but it kind of lasted a few days. Her muscles were better, but her joints still hurt some. But her joints always hurt some. She has had multiple joint replacements. The muscles in her legs were severe Friday and Saturday. Her muscles aren't hurting now, but her joints were but that was kind of normal. Her peak flow was way down on 14Feb2021. It was at 250. She did finally get it up to 350 by using her nebulizer. Her best effort normally is 450. Her peak flow was down quite a bit. She has been having breathing changes for a year. They were not sure what it was about. It could be an acute episode of something. On unknown date (next morning as reported), her pulse was 90-100. Now her heart rate was only elevated with activity. Her heart rate was down in the 70s, but when moving it was in the low 100s. With activity it was still up. It was hanging out in the 70s except exercising. She considers walking across the room exercising. All her other labs were in within normal limits. The patient wanted to know if the inflammatory response was secondary to the vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/11/2021,02/11/2021,0.0,UNK,,"Arthritis (10-15 years ago diagnosed, but she thinks she had it since she was 35.); Asthma (initially diagnosed at 21 years old)",Medical History/Concurrent Conditions: Joint replacement; Pneumonia,,,"['Arthralgia', 'C-reactive protein increased', 'Decreased appetite', 'Electrocardiogram', 'Eye pain', 'Full blood count', 'Heart rate', 'Heart rate increased', 'Inflammation', 'Laboratory test', 'Myalgia', 'Nausea', 'Oral pruritus', 'Peak expiratory flow rate', 'Pruritus', 'Pyrexia', 'Respiratory disorder']",2,PFIZER\BIONTECH, 1068235,NC,67.0,M,"fever; Patient was unable to go to work due to disorientation, confusion, headache, and chillsPatient was unable to go to work due to disorientation, confusion, headache, and chills; Patient was unable to go to work due to disorientation, confusion, headache, and chillsPatient was unable to go to work due to disorientation, confusion, headache, and chills; Patient was unable to go to work due to disorientation, confusion, headache, and chills; Patient was unable to go to work due to disorientation, confusion, headache, and chills; bronchitis; This is a spontaneous report from a contactable Pharmacist. A 67-year-old male patient received second dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 at 07:30 at single dose in left arm for COVID-19 immunisation at the age of 67-year-old. Lot number was EL3248. Medical history included Cerebrovascular accident (CVA), Hypertension, Coronary artery disease (CAD), Transient ischaemic attack, Myocardial infarction, migraine induced stroke like symptoms, seizures. Concomitant medications included acetylsalicylic acid, dipyridamole (AGGRENOX), atorvastatin calcium (ATORVASTATIN), cetirizine hydrochloride (CETIRIZINE), Clonazepam, Diclofenac sodium, valproate semisodium (Depakote), docusate sodium (COLACE), lansoprazole, lisinopril, metoprolol succinate (TOPROL XL), morniflumate (FLOMAX), tadalafil (CIALIS). The patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at 12:30 at single dose in left arm for COVID-19 immunisation at the age of 67-year-old; lot number EL0140. Patient missed worked on 03Feb2021 due to effects from COVID vaccine. Patient was unable to go to work due to disorientation, confusion, headache, and chills on 04Feb2021. The patient's employee health department advised the patient's family to send patient to be seen by emergency department (ED). Per ED note patient had complaint of intermittent confusion and disorientation, and fever. Symptoms started after he received his second Covid vaccine. Patient was alert and oriented when seen by ED physician. Patient described symptoms as coming and going, have been worse when he first wakes up. Patient has a past history of seizures and transient ischemic attack (TIA). Provider admitted making sure he was not having further seizures or TIA. Patient was observed and discharged on 05Feb2021. Per discharging provider the patient had some mild low-grade fever with negative cultures on unknown date. On 03Feb2021, nasal swab resulted negative. Provider unsure if fever due to vaccine or mild case of bronchitis (04Feb2021), patient discharged on a ZITHROMAX pack, antibiotics-one dose of Zosyn, Vancomycin, Rocephin. The patient was treated for the events. The patient recovered from the events. The patient did not have covid-19 prior to vaccination; the patient was tested for covid-19 post vaccination (nasal swab, negative). No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/02/2021,02/04/2021,2.0,PVT,AGGRENOX; ATORVASTATIN [ATORVASTATIN CALCIUM]; CETIRIZINE [CETIRIZINE HYDROCHLORIDE]; CLONAZEPAM; DICLOFENAC SODIUM; DEPAKOTE; COLACE; LANSOPRAZOLE; LISINOPRIL; TOPROL XL; FLOMAX [MORNIFLUMATE]; CIALIS,,Medical History/Concurrent Conditions: Coronary artery disease (CAD (Coronary artery disease)); CVA; Hypertension; Migraine; Myocardial infarction; Seizures; TIA,,,"['Body temperature', 'Bronchitis', 'Chills', 'Confusional state', 'Culture', 'Disorientation', 'Headache', 'Pyrexia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,OT 1068236,CA,55.0,F,"cellulitis in elbow of injected arm; This is a spontaneous report from a contactable healthcare professional (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 15Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included known allergies to penicillin and sulfa. Concomitant medication included acyclovir. The patient was not pregnant at the time of vaccination. The patient experienced cellulitis in elbow of injected arm on 03Feb2021 07:00 with outcome of recovering. Therapeutic measures were taken as a result of cellulitis in elbow of injected arm (cellulitis) with doxycycline as treatment. The event resulted in doctor or other healthcare professional office/clinic visit. The patient already took the second dose of BNT162B2 (lot number: EL9264) on 05Feb2021 08:00 at the right arm.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported cellulitis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,02/03/2021,19.0,PVT,ACYCLOVIR [ACICLOVIR],,Medical History/Concurrent Conditions: Penicillin allergy; Sulfonamide allergy,,,['Cellulitis'],1,PFIZER\BIONTECH, 1068237,FL,86.0,F,"delirious: incapable of sleeping, insomnia and inability to be awake and aware; high, over the top blood pressure; Sweating; on and off chills; she gets warm and cold, hot and cold; concerned about one kidney/ was dehydrated; affecting her kidney; incapable of sleeping, insomnia; she was weak; feeling like she would slip onto the floor; she is still not clear headed; she is woozy, like foggy; she is still not clear headed, she is woozy, like foggy; arm is still sore from second vaccine; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number EL9262 expiry date 21May2021), via an unspecified route of administration on 12Feb2021 (at the age of 86 years old) at single dose in right arm for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number EL8982) on 22Jan2021 at single dose in upper right arm and on 22Jan2021 experienced severe headache and arm hurting. Relevant medical history includes ongoing compromised immune system diagnosed many years ago, and ongoing one kidney functioning. The patient received no concomitant medications. On 13Feb2021 the patient experienced high, over the top blood pressure, delirious incapable of sleeping, insomnia and inability to be awake and aware which both required hospitalization from 13Feb2021 to 14Feb2021. It was also reported they were concerned about one kidney/ was dehydrated in 13Feb2021. On 13Feb2021 unspecified blood labs showed kidney was extremely dehydrated and Chest X-ray was good. Clinical course was reported as follows: she was just released from hospital yesterday, she took the second Pfizer COVID shot, on 12Feb2021, and became so very very ill, she expected some side effects, the first shot wasn't bad, the first all she had was a severe headache and arm hurting, but that was 3 weeks ago, and the second one she can't say how horrible it was: she had to get the paramedics there, she was very very ill. It was the worst night she has had, and she is 86 years old, and has had a multitude of serious issues but that shot was the worst. It was a combination of high blood pressure, over the top, and insomnia like she couldn't budge and open her eyes, she couldn't see anything but squares, it was like a horrible, if there is such a thing as a trip, a horrible trip, something she can't imagine wishing on anyone. The county administered it, she has several doctor, she initially provides her primary care doctor, for consent to contact, but says her nephrologist would be better, as she hasn't seen her primary care doctor in some time. Her primary care doctor doesn't know she had this, another doctor gave her permission, her nephrologist. States they were more concerned in the hospital about her kidney, she has one kidney functioning and, on mistake of the hospital, they didn't connect her to hydration, the night nurse didn't, and she was dehydrated and it was affecting her kidney. Her husband tried to call Saturday, when she had this reaction at like 06:30/07:00, but there was a huge long wait, he was calling to see about side effects, but they were beyond waiting, had to get the paramedics, her blood pressure was 178/113 and heart rate was 103. First shot was 3 weeks back. It looks like she had it on 22Jan2021, the headache and arm hurting started towards the evening, the shot was taken earlier in the day, and they started in the evening, her headache was quite severe, but with Tylenol it went away, the arm is still sore from the second vaccine, but is slightly better. Clarifies she was hospitalized for the blood pressure and delirium, like, it is best explained, like delirious: incapable of sleeping, insomnia and inability to be awake and aware, all she could see was, like if she talked about people who did LSD and trips, it was a bad trip, it was squares, she wanted to open her eyes, but could only see squares. She fell asleep Friday night about 11PM, and felt this at 04:00, and she pulled off her sleep apnea mask, she had to run to the restroom, she was weak, feeling like she would slip onto the floor, and had to get right in bed, and the insomnia continued until about 7AM, that was when she started to be able to focus on like words, she was able to say words in her mind, it was like a bad nightmare. She was admitted to the hospital, she was in the emergency room (ER), the paramedics took her there Saturday, about 07:30, took her to the hospital after immediate heart checking, an intravenous (IV) of some kind, and brought her to the hospital and she was in X-rays and what not, they did procedures in the ER, and they suggested her to be observed overnight, they watched her and things started to become more normal, but she is still not clear headed, she is woozy, like foggy. High, over the top blood pressure outcome: It has been back to a good blood pressure. Insomnia is ok- she slept ok last night. What is left: the night she woke up, so early Sunday morning, in the hospital, she was profusely sweating like someone came to her room and showered her bed with water, her sheets and blankets were soaked and this morning she woke, she got up, was still very woozy, and asked her husband to help get her out of bed, and she changed her nightgown and after an hour she got in the shower, as she was sweating again, not sweating, but occasionally on and off chills, she is taking off her nightshirt and putting on a bed jacket, she gets warm and cold, hot and cold. She had blood labs a chest X-ray, heart monitor the whole time until she was discharged, and everything was good except the kidney was extremely dehydrated. This was all on Saturday as well. On her first visit to get the vaccine, at that time, the facility was a big mall, and they handed her what to look for after the injection, and she didn't notice until this morning, it says if you have an immune system that is compromised, it could affect it, and she has immune system that is compromised diagnosed many years ago. Over the top blood pressure and insomnia had resolved, arm sore was resolving, dehydrated and affecting kidney had not resolved, final outcome of the remaining events was unknown.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/12/2021,02/01/2021,,UNK,,Immune system disorder (Verbatim: compromised immune system/Diagnosed many years ago); Single functional kidney,,,,"['Asthenia', 'Balance disorder', 'Blood pressure measurement', 'Blood test', 'Cardiovascular function test', 'Chest X-ray', 'Chills', 'Dehydration', 'Delirium', 'Disorientation', 'Dizziness', 'Feeling abnormal', 'Feeling of body temperature change', 'Heart rate', 'Hyperhidrosis', 'Hypertension', 'Insomnia', 'Pain in extremity', 'Renal impairment']",2,PFIZER\BIONTECH, 1068239,OH,,F,"feeling sick with covid symptoms; feeling sick with covid symptoms; feeling sick with covid symptoms; This is a spontaneous report from a Pfizer Sponsored program . A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 21Jan2021 at single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient felt sick with COVID symptoms on 03Feb2021. Second dose is scheduled 11Feb2021. Patient wondered when she should receive the second dose of the vaccine. The outcome of events was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,02/03/2021,13.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'Malaise']",1,PFIZER\BIONTECH, 1068240,NY,,M,"first shot was 2 weeks ago. Yesterday he tested positive for covid; first shot was 2 weeks ago. Yesterday he tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported a male patient (Reporter's Father) of an unspecified age received first dose of bnt162b2 (lot number unknown), via an unspecified route of administration, on Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had covid vaccine, first shot was 2 weeks ago. Yesterday he tested positive for covid. Inquiring how protected is he with vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Feb2021. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,02/09/2021,39.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068241,VA,74.0,F,"Sore arm with first dose; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), via intramuscular on left arm on 24Jan2021 at 18:30 at single dose for COVID-19 immunization. The relevant medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: autoimmune disease, PBC (Primary biliary cholangitis) (PBC is her autoimmune condition and was diagnosed 10 years ago). Concomitant medications were reported as none. The patient had sore arm with first dose on 24Jan2021. The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/24/2021,0.0,OTH,,,Medical History/Concurrent Conditions: Allergy; Chromosomal anomalies; Diabetic; Immune disorder (NOS); Obesity; Primary biliary cholangitis (PBC is her autoimmune condition and was diagnosed 10 years ago.); Respiratory disorder,,,['Pain in extremity'],1,PFIZER\BIONTECH,OT 1068242,,,F,"diabetic peripheral neuropathy which was hitting her hard right now; diabetic peripheral neuropathy which was hitting her hard right now; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunisation. Medical history included ongoing diabetic peripheral neuropathy. Concomitant medication included calcium mefolinate, pyridoxine hydrochloride, vitamin b12 nos (METANX) from unspecified date and ongoing for diabetic peripheral neuropathy. The patient previously received first single dose of BNT162B2 on an unspecified date for COVID-19 immunisation. It was reported that she just had her second dose on 08Feb2021 Monday. She was wondering if she could now take her METANX which was a diabetic medication. She said she didn't stop the medication, hadn't needed it for a long time, it was for her diabetic peripheral neuropathy which was hitting her hard right now. She would like to take a pill if it wouldn't hurt the vaccine. Outcome of the event was unknown. Information on lot /batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,,,UNK,METANX,Diabetic peripheral neuropathy,,,,"['Condition aggravated', 'Diabetic neuropathy']",2,PFIZER\BIONTECH, 1068244,FL,80.0,F,"Had shallow breathing; Very weak; Could not walk; Disoriented; Wanted to sleep; Incoherent; couldn't/wouldn't eat; Dehydrated; This is a spontaneous report from two contactable consumers (primary reporter was patient's husband). An 80-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included ended up in the hospital for 2 weeks with pneumonia and COVID-19 at the end of last Summer. The patient's concomitant medications were not reported. The patient's husband reported that the patient received the first Covid shot about a week to two weeks ago. She went to the facility and got the shot and was fine afterwards until she came home. Later that afternoon, she started showing symptoms of problems, was weak and couldn't walk, disoriented, wanted to sleep, was incoherent, couldn't/wouldn't eat, was very, very much having trouble, shallow breathing. He tried to stay right her and eventually it got to be scary for him with her shallow breathing. He ended up calling an ambulance and she went to the hospital. They gave her tests and was there until about 4 or 5 in the morning before she started showing signs. She was dehydrated was a part of it. The tests were showing the symptoms were improving and she was beginning to come out of it fortunately with doctor's care because he didn't know what to do. He had been going through materials and she is coming up on another shot next Monday and does not want her to go through that if it can be helped. She was coming up for the second shot. Saw something on the tv that rattled him to his bones. It had been found that people who had Covid virus previously and then got the shot may not need a second shot. He is trying to flush that out to whether or not that is something or not that she should be considering. They have the card to go back to the same place for the second shot and they are trying to figure if they need to set up an appointment now. Hoping that this was the worse of it and it is hard for them to call back and his physician is not an expert on this and he got Pfizer's office contact number and decided to call. Outcome of the events was recovering. Information on the batch/ lot number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: COVID-19; Hospitalization (At the end of last Summer she ended up in the hospital for 2 weeks with pneumonia and Covid-19.); Pneumonia,,,"['Asthenia', 'Decreased appetite', 'Dehydration', 'Disorientation', 'Gait inability', 'Hypopnoea', 'Incoherent', 'Investigation', 'Somnolence']",1,PFIZER\BIONTECH, 1068245,FL,74.0,F,"chest pains; fever over a 100�F; AFib; diabetic; COPD; stomach issues; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first dose on 25Jan2021 and experienced health issues in Jan2021 as AFib, diabetic, COPD, stomach issues, and reported to ""have a lot of issues"". The primary doctor thought it's better for her to get the dose than get COVID-19. Patient also reported that about 20 minutes after the first dose on 25Jan2021, patient had chest pains, from one side clear across the other side and took a Nitro, and patient had fever over a 100 degree F for 24 hours. The outcome of the events was unknown. Information on about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/01/2021,,UNK,,,,,,"['Abdominal discomfort', 'Atrial fibrillation', 'Body temperature', 'Chest pain', 'Chronic obstructive pulmonary disease', 'Diabetes mellitus', 'Pyrexia']",1,PFIZER\BIONTECH, 1068246,GA,,U,"The baby had to be delivered at 35 3/7 weeks; Exposure during pregnancy; Fetal tachycardia noted 1 week after the 2nd dose of the vaccine. The infant had to be delivered at 35 3/7 weeks due to non-reassuring status during monitoring; This is a Spontaneous report from a contactable physician. This physician reported information for a mother and baby. This is baby report. A neonate's mother (mother was reported as 35-year-old) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN ), intramuscular on 02Feb2021 as a single dose for COVID-19 immunization. The patients mothers medical history and concomitant medications were not reported. The baby experienced fetal tachycardia noted 1 week after the 2nd dose of the vaccine in Feb2021 (also reported as 02Feb2021). The baby had to be delivered at 35 3/7 weeks due to non-reassuring status during monitoring on. The patient was hospitalized for 5 days. The clinical outcome of Fetal tachycardia noted 1 week after the 2nd dose of the vaccine. The baby had to be delivered at 35 3/7 weeks due to non-reassuring status during monitoring was unknown. Information on lot number was requested.; Sender's Comments: Based on the available information a causal relationship between events ""fetal tachycardia noted 1 week after the 2nd dose of the vaccine"" and ""the baby had to be delivered at 35 3/7 weeks"" and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021166872 mother/fetus",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,02/02/2021,02/01/2021,,PVT,,,,,,"['Exposure during pregnancy', 'Premature baby', 'Tachycardia foetal']",2,PFIZER\BIONTECH,OT 1068247,OH,75.0,F,"AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); Nausea; Heart pounding; Lightheadedness; tingling feeling below her neck on the flat area of her upper chest; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 28Jan2021 11:00 at a single dose for COVID-19 immunisation. Medical history included Afib (diagnosed about 4-5 years ago) and stress. There were no concomitant medications. It was reported that when she got her first COVID-19 Vaccine, her arm didn't hurt, but she had a headache, sore throat, an upper throat and chest type of thing, aches (clarified as body or muscle ache in her arm or leg that occurred occasionally), a little nausea, heart pounding, and lightheadedness on an unspecified date in Feb2021. She said she has AFib (atrial fibrillation) on an unspecified date. She said she is scheduled to get her second COVID-19 Vaccine shot next Monday (22Feb2021), and wanted to know if her side effects are going to be worse. She clarified that her upper throat and chest type thing to be a tingling feeling below her neck on the flat area of her upper chest on an unspecified date in Feb2021. She said she spoke with her doctor on a video call. She said her doctor said her tingling sensation would not be from the COVID-19 Vaccine shot, and the tingling sensation maybe her sinuses on an unspecified date. She said her doctor put her on antibiotics for 10 days (prescribed Cephalexin 500mg capsules, twice a day for 10 days. She said she started the Cephalexin 500mg capsules on 05Feb2021 and finished the prescription yesterday, 15Feb2021. She said the Cephalexin 500mg capsules were dispensed in a pharmacy bottle). The patient stated that she has no other medical conditions, except stress. She said she and her husband have been quarantined, and the quarantine has felt like the longest 2 weeks of her life. It was reported that the patient still gets heart palpitations. She said the other side effects lasted 5-7 days, and improved during that time. She said the side effects have all resolved with the exception of the heart palpitations. The event atrial fibrillation was assessed as serious (medically significant). The outcome of the event heart pounding was not recovered, while recovered on an unspecified date in Feb2021 for the rest of the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/01/2021,4.0,PVT,,,Medical History/Concurrent Conditions: AFib (diagnosed with AFIB about 4-5 years ago); Stress,,,"['Atrial fibrillation', 'Chest pain', 'Dizziness', 'Headache', 'Myalgia', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Palpitations', 'Paraesthesia', 'Sinus disorder']",1,PFIZER\BIONTECH, 1068248,OR,38.0,F,"slight uptick in Sjogren's syndrome and Discoid Lupus symptoms. Her lesion opened and oozed, and dry eyes and dry mouth increased significantly.; slight uptick in Sjogren's syndrome and Discoid Lupus symptoms. Her lesion opened and oozed, and dry eyes and dry mouth increased significantly.; slight uptick in Sjogren's syndrome and Discoid Lupus symptoms. Her lesion opened and oozed, and dry eyes and dry mouth increased significantly.; This is a spontaneous report from a contactable consumer (patient) reported that a 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9264), via an unspecified route of administration on the right arm on 25Jan2021 16:30 at a single dose for Covid-19 immunization. The vaccine was administered at the hospital. The patient medical history included Systemic Lupus with Interstitial Lung Disease, Anti phospholipid syndrome, Discoid Lupus, Sjogren's Syndrome, Joint Hypermobility, Post-Traumatic Stress Disorder (PTSD), Traumatic Brain Injury (TBI), and Borderline Personality; all from an unknown date. Patient was not pregnant at the time of vaccination. Concomitant medication included buspirone taken from an unspecified date for an unspecified indication. It was reported that on 02Feb2021 08:00, the patient had slight uptick in Sjorgren's syndrome and Discoid Lupus symptoms. Her lesion opened and oozed, and dry eyes and dry mouth increased significantly. The patient will resume prednisone after 10 days as recommended by physicians. The patient received Clobetasol eye drops as treatment for the events. The outcome of the events was recovering. The patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 8982) on 15Feb2021 17:15.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/02/2021,8.0,PVT,BUSPIRONE,,Medical History/Concurrent Conditions: Antiphospholipid syndrome; Borderline personality; Discoid lupus erythematosis; Hypermobility syndrome; Interstitial lung disease; Post-traumatic stress disorder; Sjogren's syndrome; Systemic lupus erythematosus; Traumatic brain injury,,,"['Condition aggravated', 'Cutaneous lupus erythematosus', ""Sjogren's syndrome""]",1,PFIZER\BIONTECH, 1068249,CT,79.0,F,"pain in her hand/ lower part of each finger hurt; joint pain in right hand; bled quite a bit; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9263), intramuscular on 27Jan2021 (at the age of 79-years-old) as a single dose in the left shoulder for COVID-19 vaccination. Medical history included shoulder surgery about 10 years ago and she lost use of her thumb and index finger, the nerve comes from the shoulder; her hand might be numb and stiff, often but not every morning from an unknown date. Concomitant medications were reported as she is on medication but nothing she feels is relevant. On 03Feb2021, the patient experienced pain in her hand and all the lower part of each finger hurt for about 5-10 seconds, joint pain in her right hand lasting 10-15 seconds, it did not last very long; and she bled quite a bit stating she thinks she got it right in the vein on 27Jan2021. The pain happened about four different mornings but has not had pain ""since Friday"" and that was lighter sharp pain with no numbness. The clinical outcome of the event bleeding was unknown; pain in extremity and joint pain was recovered on 12Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,UNK,,,"Medical History/Concurrent Conditions: Numbness in hand (not every morning); Stiffness (hand stiff, not every morning); Surgery (about 10 years ago, affected the nerves in her fingers, lost use of thumb/index finger)",,,"['Arthralgia', 'Haemorrhage', 'Pain in extremity']",1,PFIZER\BIONTECH,OT 1068250,,30.0,M,"Fainting episode; Loss of hearing; Left collar-bone lymph node enlarged noticeable swelling to area and left lower neck near carotid artery/lymph nodes; Soreness in area; Cold sweats; Light-headedness; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 08Feb2021 at 07:00 (at the age of 30-years-old) as a single dose for COVID-19 immunization. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no symptoms until 5 days post vaccination. On 13Feb2021 at 12:15, the patient experienced fainting episode, loss of hearing, left collar-bone lymph node enlarged (noticeable swelling to area and left lower neck near carotid artery/lymph nodes), soreness in area, cold sweats, and light-headedness. The events required a visit to the physician's office and emergency room (as reported). The clinical outcomes of the fainting episode, loss of hearing, left collar-bone lymph node enlarged, soreness in area, cold sweats, and light-headedness were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,02/13/2021,5.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE,,,"['Cold sweat', 'Deafness', 'Dizziness', 'Lymphadenopathy', 'Pain', 'Syncope']",1,PFIZER\BIONTECH, 1068251,MI,85.0,M,"Developed Belle's Palsy within 48 hours; This is a spontaneous report from contactable consumers. An 85-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 03Feb2021 16:00 at single dose (left arm) for COVID-19 immunisation. Medical history included prostate cancer from 1994. The patient was not diagnosed with covid prior vaccination and since the vaccination, patient was not covid tested. Patient was not aware of any known allergies. Concomitant medication included bisoprolol. The patient did not receive no other vaccine in four weeks prior to Covid vaccine. On 05Feb2021, 15:00, the patient developed bell's palsy within 48 hours. The patient was treated with a prescription of prednisone 5mg. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of event was not recovered. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/05/2021,2.0,UNK,BISOPROLOL,,Medical History/Concurrent Conditions: Prostate cancer,,,['Facial paralysis'],1,PFIZER\BIONTECH, 1068253,KS,40.0,M,"under my lymph nodes are very painful; right arm was sore for first 2 days/under my right arm are very painful; This is a spontaneous report from a contactable consumer (patient himself). A 40-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in right arm on 12Feb2021 13:45 at single dose for COVID-19 immunisation. The patient's medical history included COVID-19 from an unspecified date in Nov2020 (diagnosed with COVID 19 at the end of November 2020 but tested negative since from Dec onwards 2020). Concomitant medication included finasteride at 1 mg (within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. It was reported that, my right arm was sore for first 2 days on an unspecified date in Feb2021, however since Monday (15Feb2021 06:00 AM) under my lymph nodes, under my right arm are very painful. The events were considered as non-serious by the consumer. The patient did not receive treatment for the adverse events. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/01/2021,,WRK,FINASTERIDE,,Medical History/Concurrent Conditions: COVID-19 (Diagnosed with COVID 19 at the end of November 2020 but tested negative since from Dec onwards 2020),,,"['Lymph node pain', 'SARS-CoV-2 test', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1068254,KS,,F,"anaphylaxis; head was feeling funny; sweating profusely; This is a spontaneous report from a contactable consumer (patient). This 79 (unit unknown) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 10Feb2021 at 12:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose on 10Feb2021 at 12:00. On the same day (10Feb2021), at 20:00, the patient's head was feeling funny, sweating profusely, and felt like ""anaphylaxis"". Patient also asked about potential receipt of second dose. Patient stated she will reach out to healthcare professional (HCP). Outcome of the events was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,02/10/2021,0.0,UNK,,,,,,"['Anaphylactic reaction', 'Feeling abnormal', 'Hyperhidrosis']",1,PFIZER\BIONTECH, 1068255,NC,71.0,M,"neuropathy on feet, arms, and chest; chills; fatigue; lack of sleep for the last 12 days; This is a spontaneous report from a contactable consumer, reporting for himself. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264), via an unspecified route of administration at the left arm on 29Jan2021 10:00 at a single dose for COVID-19 immunization. Vaccination was administered at a military base. Medical history included hypertension (controlled with medication) from an unknown date and unknown if ongoing. There were no known allergies. There was no other vaccine in four weeks. Concomitant medication included lisinopril, felodipine and tamsulosin (reported as medications in two weeks). On 04Feb2021 at 17:00, the patient experienced chills, fatigue, neuropathy on feet, arms, and chest and lack of sleep for the last 12 days. The patient was advised to drink plenty of water and take Tylenol. The patient had no COVID prior vaccination. The patient was not COVID tested post vaccination. The events required a doctor office and emergency room visits. The patient underwent lab tests and procedures which included influenzas A: negative, influenzas B: negative, both on unspecified dates; and COVID-19 nasal swab: negative on 08Feb2021, 11Feb2021 and 12Feb2021. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/04/2021,6.0,MIL,LISINOPRIL; FELODIPINE; TAMSULOSIN,,Medical History/Concurrent Conditions: Hypertension (controlled with medication),,,"['Chills', 'Fatigue', 'Influenza A virus test', 'Influenza B virus test', 'Insomnia', 'Neuropathy peripheral', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068256,FL,74.0,F,"my chest started hurting me at 3:50 a.m. this morning; stomach hurts; felt squeezed, I could not breath; had the feeling of being squeezed; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiry date unknown), via an unspecified route of administration on 15Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 25Jan2021 and experienced AFib, diabetic, COPD, stomach issues, chest pains and fever. About 20 minutes after the first dose, I had chest pains, from one side clear across the other side. She took a nitro, and had fever over a 100�F for 24 hours on Jan2021. She received second dose on 15Feb2021 and experienced they had her get an EKG. Patient felt squeezed, she could not breath on Feb2021. Her oxygen level and blood pressure were both fine on Feb2021. She had the feeling of being squeezed on Feb2021. Her chest started hurting at 3:50 a.m. (16Feb2021) this morning, stomach hurts like doing flip flops inside her. She did not have anything that would aggravate it. The outcome of the events was unknown. The events was reported as non-serious. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/15/2021,02/01/2021,,UNK,,,,,,"['Abdominal pain upper', 'Blood pressure measurement', 'Body temperature', 'Chest pain', 'Feeling abnormal', 'Oxygen saturation', 'Respiratory arrest']",2,PFIZER\BIONTECH, 1068257,WA,43.0,F,"Itching throat; cough; Taste and smell loss; Taste and smell loss; Taste and smell loss; mild anaphylactic reaction; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 06:30 (at the age of 43-years-old) at a single dose for COVID-19 immunisation. Medical history included COVID-19 (with taste and smell loss). The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), hydroxyzine hydrochloride (MANUFACTURER UNKNOWN), and duloxetine (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 17Dec2020 at 14:00 in the left arm for COVID-19 immunization and experienced head to toe itching and progress with taste and smell disappeared/worse than COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild anaphylactic reaction on 16Jan2021 at 20:00 and itching throat, cough, and taste and smell loss on an unspecified date. The patient reported that all the progress she made with taste and smell, disappeared after the vaccine and was actually worse than when she got COVID-19. Therapeutic measures were taken as a result of mild anaphylactic reaction, which included diphenhydramine hydrochloride (BENADRYL). The clinical outcome of mild anaphylactic reaction was not recovered and of itching throat, cough, and taste and smell loss was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of event anaphylactic reaction cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/16/2021,1.0,PVT,WELLBUTRIN; HYDROXIZINE; DULOXETINE,,Medical History/Concurrent Conditions: COVID-19 (with taste and smell loss),,,"['Ageusia', 'Anaphylactic reaction', 'Anosmia', 'Condition aggravated', 'Cough', 'Throat irritation']",2,PFIZER\BIONTECH, 1068258,,,F,"has multiple myeloma and diabetes; has multiple myeloma and diabetes; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the first dose of the Pfizer COVID vaccine on the 29Jan2021 and she was due for the second dose today (as reported). She wanted to know if she can take her prescribed medications oxycodone (with acetaminophen), Synthroid, Valtrex, lisinopril oxycontin, diabetic sliding scale Humalog, Lantus, Wellbutrin, Infusion for multiple myeloma, Kyprolis and Aspirin 81. The patient stated that she has multiple myeloma and diabetes on an unspecified date. The events were assessed as serious (medically significant). The outcome of the events was unknown. The information about the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,,,UNK,,,,,,"['Diabetes mellitus', 'Plasma cell myeloma']",1,PFIZER\BIONTECH, 1068259,,81.0,F,"muscle spasms; bad fibromyalgia; runny nose; This is a spontaneous report from a contactable consumer (patient). This 81-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 (at the age of 81 years old), for COVID-19 immunisation. Medical history included highly allergic to some medications and bleeding disorder (she was on a blood thinner). Concomitant medications were not reported. On an unspecified date the patient experienced muscle spasms and spent 3 days at the hospital. She had to go again on an unspecified date in Feb2021, she got a lot of illnesses, she was also on a blood thinner and was highly allergic to some medications. Since an unspecified date she had really bad fibromyalgia. All these symptoms were usual for the patient, other than the runny nose. She needed to get a hold of her doctor, she had a follow up like right now. She wasn't supposed to go (for her appointment) until the 23Feb2021. She was scheduled for the second vaccine dose on 08Feb2021, however she was in the hospital and was wondering if it was too late. Events outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/18/2021,,,UNK,,,Medical History/Concurrent Conditions: Coagulopathy (on a blood thinner); Drug allergy,,,"['Fibromyalgia', 'Muscle spasms', 'Rhinorrhoea']",1,PFIZER\BIONTECH, 1068260,MD,44.0,F,"Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP = 180/120/her BP was high; feeling lightheaded; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot: EN6201, expiry: Jun2021), intramuscular (IM) on left (L) arm (at the age of 44years) on 16Feb2021 at 12:00 at single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (lot: EN5318, expiry: Jun2021) IM on L arm on 28Jan2021 at 14:45 that 45 minutes after administration (on 28Jan2021) the patient experienced tingling sensation on lip which was with diphenhydramine hydrochloride (BENADRYL) as treatment and recovered on unspecified date. Medical history included hypertension, allergic to fish (treatment were adrenaline (EPIPEN), corticosteroid and antihistamine) and ongoing BP. Concomitant medications included ongoing hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) and ongoing unspecified Vitamins daily. The patient previously took prochlorperazine maleate (COMPAZINE) and metoclopramide (REGLAN) which were medications she took while pregnancy, gabapentin and hydromorphone hydrochloride (DILAUDID) where the patient experienced allergies from these drugs and treatment were adrenaline (EPIPEN), corticosteroid and antihistamine. There was no covid prior vaccination and was covid tested post vaccination with Nasal Swab (Sofia SARS Antigen) on 04Feb2021 with result of negative. The patient experienced severe anaphylaxis attack on 16Feb2021 at 12:30 (30 minutes after the administration of 2nd dose) which resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event) with treatment included Intravenous IV diphenhydramine hydrochloride (BENADRYL) + prednisone + famotidine (PEPCID), GI cocktail, Heart monitoring. The HCP (patient) was on observation for 30 minutes when she started with tingling sensation, sweating and feeling hot (in Feb2021). They took BP=180/120 (in Feb2021). They administered IV diphenhydramine hydrochloride + prednisone + famotidine. She was feeling lightheaded (in Feb2021). She stayed in observation for 4 hours until recovered. She was sent home and prescribed prednisone and loratadine (CLARITIN) daily. HCP stated that she has an episode yesterday (16Feb2021), she was feeling tired, the sweating came back and her BP was high. Today (19Feb2021) her BP was stable. The patient reported tachycardia under information on organ involvement (in Feb2021). The patient required medical intervention but not hospitalized nor admitted to an intensive care unit. No other vaccine in four weeks and no other medications in two weeks. The patient did not receive any recent vaccines for any other conditions prior to the events and did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the events. The outcome was recovered for the events anaphylaxis and dizziness both in Feb2021, and hypertension on 19Feb2021 while for the remaining events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Anaphylaxis cannot be excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/16/2021,02/01/2021,,UNK,LISINOPRIL + HIDROCLOROTIAZIDA,Blood pressure abnormal,"Medical History/Concurrent Conditions: Fish allergy (treatment were adrenaline (EPIPEN), corticosteroid and antihistamine); Hypertension",,,"['Anaphylactic reaction', 'Blood pressure measurement', 'Dizziness', 'Fatigue', 'Feeling hot', 'Hyperhidrosis', 'Hypertension', 'Paraesthesia', 'SARS-CoV-2 test', 'Tachycardia']",2,PFIZER\BIONTECH,OT 1068262,PA,42.0,M,"random heart-racing; random dizziness; occasional headaches; Temperature between 100-102 for 30hrs; flu-like symptoms; extreme burning resulting in fainting; extreme burning; This 42-year-old male patient contactable consumer (reported for himself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot EN5318,; expiration not provided), via an unspecified route of administration, on 14Feb2021, 12:00 PM (at the age of 42-year-old) as a single dose for COVID-19 immunization, in Left arm. The facility where COVID-19 vaccine was administered was at a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical Vaccine included first dose of BNT162B2 (Lot number: el8982) intramuscularly on 24Jan2021 at 09:00 am for COVID-19 immunization on left arm. The patient did not have any other vaccine within four weeks prior to the vaccination. No relevant medical history reported. Concomitant medication included: Levothyroxine 125 ""mg"", once a day. On 14Feb2021 at 12:15pm, the patient experienced extreme burning resulting in fainting. Ekg normal in ER. Day-2 flu-like symptoms, temp between 100-102 for 30hrs. Day-2 and now day-3, random dizziness, feeling of heart beat, random heart-racing, occasional headaches, no current fever. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The clinical outcome of the events extreme burning resulting in fainting, flu-like symptoms, temp between 100-102 for 30hrs, random dizziness, random heart-racing, occasional headaches, was unknown. It was reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/14/2021,02/14/2021,0.0,PVT,LEVOTHYROXINE,,,,,"['Body temperature', 'Burning sensation', 'Dizziness', 'Electrocardiogram', 'Headache', 'Influenza like illness', 'Palpitations', 'Pyrexia', 'Syncope']",2,PFIZER\BIONTECH, 1068263,TX,83.0,F,"fractured T12; unable to walk on own; Fell; largely stopped eating and drinking; enfeebled; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: el9269), via an unspecified route of administration at left arm on 02Feb2021 13:00 at a single dose for COVID-19 immunization. Medical history included T-cell large granular lymphocytic (tCell LGL), type 2 diabetes and high blood pressure. No known allergies. No COVID prior vaccination. The patient is not pregnant at the time of vaccination. No other vaccine in four weeks. There were other medications in two weeks (unspecified). Within a week, patient was unable to walk on own. She fell and fractured T12. On 02Feb2021, she walked on her own to the car, got in the car, then out of the car, walked to the injection site, including standing in a long line, and walked back to the car. She was aware, recognized people and places, and walked from the car to her home. On 05Feb2021 12:00 (also reported as 'during 02Feb2021 thru 08Feb2021), she largely stopped eating and drinking. Within the week on 05Feb2021 12:00, she was enfeebled. At about 01:30 on 08Feb2021, she fell and fractured her back. She is now awaiting acceptance at a rehab facility. The events unable to walk on own and fractured T12 resulted to hospitalization and disability or permanent damage. The patient was hospitalized for 4 days. The events required Emergency room/department or urgent care visit. Various medical tests and treatments were administered as treatment for the events. Patient tested for COVID post vaccination. Covid test post vaccination on 11Feb2021: (covid test type post vaccination: Unknown) Negative. The outcome of the events was not recovered.",Not Reported,,Not Reported,Yes,4.0,Yes,N,02/02/2021,02/01/2021,,PVT,,,Medical History/Concurrent Conditions: Hypertension; T-cell large granular lymphocytic leukemia; Type 2 diabetes mellitus,,,"['Asthenia', 'Decreased appetite', 'Fall', 'Gait inability', 'Investigation', 'SARS-CoV-2 test', 'Thoracic vertebral fracture']",1,PFIZER\BIONTECH, 1068264,FL,82.0,M,"bilateral blood clots in legs that then went to lungs then went into BLAST crisis; bilateral blood clots in legs that then went to lungs then went into BLAST crisis; bilateral blood clots in legs that then went to lungs then went into BLAST crisis; Patient with myeloid leukaemia (CML) and WBCs abnormal received BNT162B2; Patient with myeloid leukaemia (CML) and WBCs abnormal received BNT162B2; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiration date unknown) via an unspecified route of administration in the left arm on 02Feb2021, 13:00PM (at 82 years old) at a single dose for COVID-19 immunization. The patient was vaccinated in the Nursing Home/Senior Living Facility. The patient's medical history included myeloid leukaemia (CML) diagnosed a few months earlier, WBCs abnormal, blood pressure, and heart surgery valve repair. The patient has no known allergies. Concomitant medications included atorvastatin, carvedilol, vitamin d nos, dasatinib monohydrate (SPRYCEL) from an unknown date to help get WBCs back in normal range; cyanocobalamin (VITAMIN B12), and cetirizine hydrochloride (ZYRTEC), all were received within 2 weeks of vaccination. At 82 years old, the patient received the first dose of BNT162B2 (lot number and expiration date unknown) via an unspecified route of administration in the left arm on 12Jan2021 at a single dose for COVID-19 immunization. The patient was not diagnosed with COVID prior to vaccination and did not receive any other vaccines within 4 weeks prior to BNT162B2. It was unknown if patient was tested for COVID post vaccination. On Friday (unknown date in Feb2021), patient's WBC was 150,000 and on Saturday (unknown date in Feb2021), patient had bilateral blood clots in legs that then went to lungs then went into BLAST crisis. The adverse events resulted in emergency room/department or urgent care as well as hospitalization due to life threatening illness (immediate risk of death from the events). The patient was hospitalized for 12 days. Therapeutic measures which include steroids, blood thinners, and lots of other meds were administered. Outcome of the events ""patient's WBC was 150,000"" and ""bilateral blood clots in legs that then went to lungs then went into BLAST crisis"" was recovering. Information on the lot/ batch number has been requested.",Not Reported,,Yes,Yes,12.0,Not Reported,N,02/02/2021,02/01/2021,,SEN,ATORVASTATIN; CARVEDILOL; VITAMIN D NOS; SPRYCEL; VITAMIN B12 [CYANOCOBALAMIN]; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Blood pressure abnormal; Chronic myelogenous leukemia; Heart valve replacement; WBC abnormal,,,"['Blast cell crisis', 'Off label use', 'Product use issue', 'Pulmonary embolism', 'Thrombosis', 'White blood cell count']",2,PFIZER\BIONTECH, 1068265,FL,69.0,M,"Loss of taste and partial smell; Loss of taste and partial smell; Hard to talk or eat or drink; Hard to talk or eat or drink; Hard to talk or eat or drink; Bells Palsy; Blurry vision; Fever; Felt achy; This is a spontaneous report from a contactable consumer (patient). This 69-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261), via an unknown route, on 29Jan2021 (at 10:00 AM) at a single dose in the left arm for COVID-19 immunisation. Relevant medical history includes diabetes, arteriolosclerosis, blocked carotid artery, gastrooesophageal reflux disease (GERD) and chronic prostatitis. Past drug history included allergy to penicillin and cefixime (FLEXERIL). Relevant concomitant medications included doxazosin mesylate (CARDURA), lisinopril, metformin, omeprazole, repaglinide (PRANDIN) and other unspecified medications. He had fever and felt achy for a couple of day. On 03Feb2021 (at 08:00), the patient had total paralyzed on right side of his face, right eye will not close, mouth paralyzed on right side. Hard to talk or eat or drink. Blurry vision in right eye due to not closing. On 04Feb2021, the patient has loss of taste and partial smell. The patient performed physician office visit. Then, he went to the emergency room (ER) and Bells Palsy was confirmed on 06Feb2021. He stated that his blood work is currently fine. He was given prednisone and acyclovir for Bells Palsy and for hard to talk or eat or drink. The patient was not treated for the remaining events. Pre and post vaccination COVID test were not performed. All events were considered serious for disability except of fever and felt achy. The outcome of the events fever and felt achy was unknown while the outcome of the remaining events was not recovered.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/29/2021,02/03/2021,5.0,UNK,CARDURA; LISINOPRIL; METFORMIN; OMEPRAZOLE; PRANDIN,,Medical History/Concurrent Conditions: Atherosclerosis; Carotid artery disease; Chronic prostatitis; Diabetes; GERD,,,"['Ageusia', 'Anosmia', 'Blood test', 'Eating disorder', 'Facial paralysis', 'Pain', 'Pyrexia', 'Speech disorder', 'Vision blurred', 'Water pollution']",1,PFIZER\BIONTECH, 1068267,FL,,F,"Shingles; This is a spontaneous report from a contactable consumer (consumer). A female patient of an unspecified age received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know if it is okay to receive as scheduled on 20Feb2021 her second dose of Pfizer-BioNTech COVID-19 Vaccine if she has shingles. She stated that she went to the hospital because of it and it started 2 and a half weeks ago. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,['Herpes zoster'],1,PFIZER\BIONTECH, 1068268,,84.0,F,"stroke; This is a spontaneous report from a contactable Pharmacist, the patient's daughter-in-law. An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Feb2021 (at the age of 84-years-old) as a single dose for COVID-19 vaccination. Medical history included stroke and atrial fibrillation from unknown dates. Concomitant medications were not reported. On 12Feb2021, the patient experienced a stroke. The clinical outcome of the event stoke was unknown. No additional information was reported. Information about lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/12/2021,7.0,UNK,,,Medical History/Concurrent Conditions: Atrial fibrillation; Stroke,,,['Cerebrovascular accident'],1,PFIZER\BIONTECH, 1068269,CA,69.0,F,"eczema flare up, skin red, her left anterior chest was burning and itchy, skin pain; headache; on early Friday evening she ended up with joint pain that was so bad, she thought she was going to die. She said her wrist, elbows, fingers, hips, knees, every joint down to her ankles, hurt; This is a spontaneous report from a contactable nurse (patient; retired nurse) via a Pfizer-sponsored program. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6201), via an unspecified route of administration in the right deltoid on 10Feb2021 at 12:35 PM (at age of 69 years old) at a single dose for COVID-19 immunization. The vaccine was administered to the patient at a convention center. The patient's medical history included eczema from 24Dec2018 and ongoing, rosacea (developed Rosacea at 65 years old), and the patient also reported that she used to be 5'4"" and she lost 2 inches. She said she had a bone density test recently and was told she is 5'2"". She said she objected to the measurement of 5'2"", so the nurse told her to stand as tall as she can, and then the nurse noted her height as 5'2-1/2"". There were no concomitant medications. There were no additional vaccines administered on same date of BNT162B2. The patient had no prior vaccinations within 4 weeks. On 12Feb2021, the patient experienced eczema flare up, skin red, her left anterior chest was burning and itchy, headache, skin pain, and ""joint pain that was so bad, she thought she was going to die. She said her wrist, elbows. fingers, hips, knees, every joint down to her ankles, hurt"". The patient said she received her first COVID-19 Vaccine on 10Feb2021. She said everything was fine after she received her COVID-19 Vaccine. She didn't even have a mark on her arm where she received the COVID-19 Vaccine. The patient reported that she got the first dose of the COVID-19 vaccine on 10Feb2021 and is due to the second dose on 03Mar2021. Approximately 2 and half days later she got an eczema flare that was quite severe out of the blue since she was having eczema diagnosed since she was 67 (as reported; she is 69 today). She still has some itching and burning and she wondered if this was something that has been reported also for other psoriasis/eczema patients. She was concerned about taking the second dose since she thinks this may be caused by the vaccine as she stated that nothing has changed in her life aside the vaccination. The patient reported she takes tacrolimus for the treatment of her eczema. Also she said that she had some joint pain for a couple of days. She said 2-1/2 days later (Friday, 12Feb2021), out of the blue, she had an eczema flare up. She said she was diagnosed with eczema at 67 years old. She said Friday night (12Feb2021) into Saturday (13Feb2021) her left anterior chest was burning and itchy. She clarified her skin was really red and angry looking, and painful. She said she has not had any pain with her eczema in a long time. She said she took topical ointments and medication for the eczema flare up. She said she was surprised at the intensity of her eczema flare up. She clarified her initial diagnosis for eczema was on her left anterior chest and bra strap area, and arms. She said she has never had eczema on her face or any other part of her body. She said she was totally asymptomatic prior to getting her first COVID-19 Vaccine. She said on early Friday evening (12Feb2021) she ended up with joint pain that was so bad, she thought she was going to die. She said her wrist, elbows, fingers, hips, knees, every joint down to her ankles, hurt. She said she had a headache. She said by Sunday (14Feb2021) her joint pain and headache were gone. She said her symptoms went away so quickly. The patient asked if people reported a flare up with psoriasis or eczema after getting the COVID-19 Vaccine and if should she have any concerns about getting the second COVID-19 Vaccine shot on 03Mar2021. The patient her eczema treatment included a combination of oral and topical medications. She clarified she used more of the prescription topical lotion than the over-the-counter oral medications. She received Famotidine 10mg (clarified as Pepcid AC; NDC Number: 11673-031-65, Lot Number: OFE2821, Expiration Date: Feb2022). Her doctor told her she could take up to 20mg of Famotidine if her symptoms were bad. She said on Friday (12Feb2021) and Saturday (13Feb2021) she took 20mg of the Famotidine until she felt her symptoms were under control. The patient also received cetirizine 10 mg (reported as generic Zyrtec; NDC Number: 11673-502-87, Lot Number: 8ME2877A, Expiration Date: Sep2022). The patient reported that she took 20mg of the generic Zyrtec for the itching. She said her doctor told her she can take up to 20mg of the generic Zyrtec, if needed for itching. She said otherwise, she would normally take 10mg generic Zyrtec, as needed. The patient also received Tacrolimus Ointment 0.1% (Protopic Ointment; NDC Number: 0168-0416-30, Lot Number: JZ8459, Expiration Date: Apr2021), applied to affected areas twice a day and Triamcinolone Acetonide Cream, 0.1% (she stated she refers to it as ""TAC"" Cream; NDC Number: 67877-251-80, Lot Number: Y064, Expiration Date: Oct2022). The patient reported that she uses the ""TAC"" Cream under her breasts where her bra sits because the ""TAC"" Cream is less expensive than the Tacrolimus Ointment 0.1%. She said she uses the ""TAC"" Cream as needed, and the ""TAC"" Cream keeps her skin hydrated. She said she used the Protopic Ointment (Tacrolimus Ointment 0.1%) on Friday (12Feb2021), and then switched to the ""TAC"" Cream. The patient has had no itching or pain since early Monday (15Feb2021). Her joint pain and headache treatment included Advil Liquid Gel 200mg (UPC Number: 305730169080, Lot Number: 56264, Expiration Date: Jun2023). She said she took a couple Advil Liquid Gels on Friday (12Feb2021). The patient reported that she switched from Tylenol to Motrin because the Motrin worked well. She clarified she meant Ibuprofen when she said Motrin. She said she calls everything Motrin when she is referring to Ibuprofen. She said she took Tylenol occasionally and never felt the Tylenol worked. She said she hasn't taken Tylenol in a long time. She said Tylenol didn't work as well as the NSAIDs. She did not have the Tylenol NDC, Lot, and Expiration Date. The patient reported that she takes Bufferin Brand Aspirin normally for pain. She said she sees someone who treats her holistically, and that person recommended the Bufferin Aspirin because it was not as damaging to the body. She said since the Bufferin Aspirin takes longer to work, she took the Advil Liquid Gel for faster pain relief. No further details provided. The events eczema flare up, skin burning sensation, skin red, skin pain, joint pain, and headache were reported as serious - medically significant. The patient reported that she felt her symptoms were medically significant because her eczema flare up was so different from what she has ever experienced before. She said nothing had changed in her routine, and she has been in control of her eczema. She said she has had only very minor eczema flare ups. The events did not require a visit to emergency room and to physician office. The outcome of the events eczema flare up and skin red was recovering. The outcome of the events headache and joint pain was recovered on 14Feb2021. The outcome of the events skin burning sensation, skin pain, and itchy skin was recovered on 15Feb2021. The events eczema flare up, skin burning sensation, itchy skin, skin red, skin pain, joint pain, and headache were assessed by the (patient) as related to BNT162B2.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/12/2021,2.0,UNK,,Eczema,Medical History/Concurrent Conditions: Body height decreased; Rosacea (developed Rosacea at 65 years old),,,"['Arthralgia', 'Eczema', 'Headache']",1,PFIZER\BIONTECH, 1068270,,71.0,F,"Suffered a stroke 4 days later 06Feb2021; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 02Feb2021 at 14:45 (at the age of 71-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient suffered a stroke 4 days later 06Feb2021 after vaccination. The event resulted in an emergency room/department visit and hospitalization in Feb2021 for 3 days. Treatment for the event stroke included medication and therapy. The outcome of the event stroke was recovering. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/02/2021,02/06/2021,4.0,SCH,,,,,,['Cerebrovascular accident'],1,PFIZER\BIONTECH,OT 1068271,,,F,"Anaphylactic response to Covid vaccine; stopped breathing; fever; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sales representative. An adult female patient of unspecified age (reported as mid-twenties) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history included allergy to steroids. The patient's concomitant medications were not reported. The patient previously took propylene glycol and the patient was allergic to propylene glycol. On an unspecified date, the patient had an anaphylactic response to Covid vaccine. The patient stopped breathing. She was treated with epinephrine and transported to the hospital. The patient received other fluids and was and was released a day later when her fever was below 100F. The patient had similar allergy to steroids and did not connect that she was allergic to propylene glycol. It was reported that the events took place after use of the vaccine. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Specific allergy (drug) (allergy to steroids),,,"['Anaphylactic reaction', 'Body temperature', 'Pyrexia', 'Respiratory arrest']",1,PFIZER\BIONTECH, 1068272,NC,,F,"posterior vitreous detachment of left eye; This is a spontaneous report from a contactable pharmacist. A 44-year-old female pharmacist reported for herself that received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9261), via an unspecified route of administration left arm single dose on an unspecified date for covid-19 immunisation. Medical history included Crohn's disease, drug hypersensitivity to NSAIDs. Concomitant medication included certolizumab pegol (CIMZIA). The patient experienced posterior vitreous detachment of left eye on 11Feb2021. Laser treatment was used to repair. The outcome was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,02/11/2021,,PVT,CIMZIA,,Medical History/Concurrent Conditions: Crohn's disease; Drug allergy (to NSAIDs),,,['Vitreous detachment'],1,PFIZER\BIONTECH, 1068273,GA,78.0,M,"artery had been nicked and they went in and fixed that; lower right abdominal area was swollen and he was in a lot of pain; lower right abdominal area was swollen and he was in a lot of pain; he had a hernia removed; his hemoglobin has been going up and down; He shrunk, he is 5'11.75; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient just recently had surgery he had a hernia removed and a week after that; he had the operation done arthroscopically and a week after that; the lower right abdominal area was swollen and he was in a lot of pain and he ended up going to the hospital and they admitted him in the ER and they gave him some Morphine and hooked up to all kinds of stuff and eventually they found out that an artery had been nicked and they went in and fixed that and his hemoglobin has been going up and down. At any rate he had surgery again and they cleaned out all of that blood and they didn't find any more leaks but the patient's wife was wondering if it would be okay to have the booster for the COVID vaccine on 18Feb2021 (Thursday). The patient's wife confirmed that all of this happened since him having the first dose of the vaccine, but it was not related. The patient's wife also reported that the patient's height shrunk, and he was 5'11.75"". The outcome of artery had been nicked was recovered, and unknown for the rest of the events. Information on the lot/batch number has been requested.; Sender's Comments: There is no reasonable possibility that the reported events were related to BNT162b2. These are more likely associated with the surgical condition and post surgical complications.",Not Reported,,Not Reported,Yes,,Not Reported,Y,,,,UNK,,,,,,"['Abdominal distension', 'Abdominal pain lower', 'Arterial rupture', 'Body height', 'Body height decreased', 'Haemoglobin', 'Haemoglobin abnormal', 'Hernia']",1,PFIZER\BIONTECH, 1068275,PA,68.0,F,"I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; Unable to eat, loss of appetite.; Not feeling too well; very sick; can hardly move; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9069), via an unspecified route of administration at single dose on 10Feb2021 for covid-19 immunisation. Medical history included diabetes, thyroid removed. Concomitant medication included influenza vaccine, metformin, levothyroxine, ferrous sulfate, atorvastatin. The patient stated that experienced: I got fever, I got diarrhea. I got body ache, headache, unable to eat, loss of appetite, not feeling too well, very sick, can hardly move , all on an unspecified date in Feb2021 with outcome of unknown. The patient was hospitalized for these events from Feb2021 to an unknown date. The patient underwent lab tests and procedures which included investigation: unknown results in Feb2021.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/10/2021,02/01/2021,,PVT,INFLUENZA VACCINE; METFORMIN; LEVOTHYROXINE; FERROUS SULFATE; ATORVASTATIN,,Medical History/Concurrent Conditions: Diabetes; Thyroidectomy,,,"['Body temperature', 'Decreased appetite', 'Diarrhoea', 'Headache', 'Hypokinesia', 'Illness', 'Investigation', 'Malaise', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 1068277,NY,83.0,F,"Immediate brain fog and continued for 2 days; This is a spontaneous report from a contactable consumer (patient). The 83-year-old female patient receive second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer) , via an unspecified route of administration on 15Feb2021 on Right arm at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer) , via an unspecified route of administration on 25Jan2021on Right arm at single dose for covid-19 immunization. The patient experienced immediate brain fog and continued for 2 days on 15Feb2021 12:00 PM with outcome of recovered. No treatment received. She is not pregnant. Facility type vaccine was other. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,UNK,,,,,,['Feeling abnormal'],2,PFIZER\BIONTECH, 1068278,NC,69.0,M,"Injection site pain and swelling for 48 hours; Injection site pain and swelling for 48 hours; headache 24 hour; feeling unwell for 24 hours; tiredness for 24 hours; This is a spontaneous report from a contactable consumer. The consumer reported for himself that the 69-years-old male patient received second dose of bnt162b2 (BNT162B2,COVID 19, brand: pfizer, lot number: GM9810), via an unspecified route of administration on 17Feb2021 10:00AM on Right arm at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, brand: pfizer, lot number: EL9261), via an unspecified route of administration on 27Jan2021 on Right arm at single dose for covid-19 immunisation. The patient experienced injection site pain and swelling for 48 hours, headache 24 hour, feeling unwell for 24 hours, tiredness for 24 hours all on 18Feb2021 06:00AM with outcome of recovered. Facility where the most recent COVID-19 vaccine was administered was other. The patient received other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. The case was assessed non-serious.Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Location of injection information is available for other vaccines within 4 weeks PRIOR.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,SCH,,,,,,"['Fatigue', 'Headache', 'Malaise', 'Vaccination site pain', 'Vaccination site swelling']",2,PFIZER\BIONTECH, 1068280,CA,75.0,F,"pneumonia; This is a spontaneous report from a Pfizer-sponsored program. Contactable consumers reported that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL1284, via an unspecified route of administration on 26Jan2021 at single dose for COVID-19 immunization. Medical history included cholesterol (abnormal) and asthma. Concomitant medication included budesonide, simvastatin for cholesterol and benralizumab (FASENRA) for asthma. She has got a lot of other medications (at least 15 medications). The patient was hospitalized this week due to a pneumonia on 13Feb2021 (in between 1st dose and 2nd dose). The patient was in a hospital for 7 hours in and out. She was hospitalized in 13Feb2021. She missed the 2nd appointment today (16Feb2021) 11:30AM and they were informed that they need to call. The healthcare professional advised not to as she was on antibiotics (levofloxacin 750 mg) for pneumonia which was contracted after the first dose. She then wanted to reschedule her second dose. The patient underwent lab tests and procedures which included blood, x-rays, CAT scan and tested for virus, influenza. The tests were done in the hospital and she way okay.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/26/2021,02/13/2021,18.0,UNK,BUDESONIDE; SIMVASTATIN; FASENRA,,Medical History/Concurrent Conditions: Asthma; Blood cholesterol abnormal,,,"['Blood test', 'Computerised tomogram', 'Investigation', 'Pneumonia', 'X-ray']",1,PFIZER\BIONTECH, 1068281,,,M,"positive for strep; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown date (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient was positive for strep (in 2021) and put on antibiotics. The patient was on antibiotics for 24 hours and second dose was due today and wanted to know if it was okay to be on the antibiotics with vaccination. The outcome of the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The event ""patient was positive for strep"" is attributed to an intercurrent medical condition that was not related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Bacterial infection', 'Streptococcus test positive']",1,PFIZER\BIONTECH,OT 1068282,MA,,F,"she could have had a mild stroke; Headache; stroke type symptoms of confusion, difficulty talking and right side of face felt funny; stroke type symptoms of confusion, difficulty talking and right side of face felt funny; stroke type symptoms of confusion, difficulty talking and right side of face felt funny; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got a headache after covax last week Wednesday. On Thursday (unknown date), she had stroke type symptoms of confusion, difficulty talking and right side of face felt funny. The patient was taken to the emergency room on Friday and they said she could have had a mild stroke even though her tests were all negative. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Cerebrovascular accident', 'Confusional state', 'Facial discomfort', 'Headache', 'Investigation', 'Speech disorder']",1,PFIZER\BIONTECH, 1068283,MA,,F,"Callers dr developed Diverticulitis after first dose/she is having a recurrence of her diverticulitis; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer Sponsored Program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunization. Medical history included diverticulitis from an unknown date and unknown if ongoing (she mentioned she is now having similar symptoms to when she first had diverticulitis). The patient's concomitant medications were not reported. The patient experienced diverticulitis after first dose/she is having a recurrence of her diverticulitis on an unspecified date. The patient underwent lab tests and procedures which included abdominal cat scan: diagnosed with diverticulitis on 24Dec2020. Therapeutic measures were taken as a result of the event and included treatment with AUGMENTIN. The patient outcome of the event was unknown. The information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,,,UNK,,,Medical History/Concurrent Conditions: Diverticulitis (She mentioned she is now having similar symptoms to when she first had diverticulitis.),,,"['Computerised tomogram', 'Diverticulitis']",1,PFIZER\BIONTECH, 1068284,FL,,F,"has an appointment tomorrow for the 2nd dose but she tested positive on 08Feb; has an appointment tomorrow for the 2nd dose but she tested positive on 08Feb; This is a spontaneous report from Pfizer-sponsored program received from a contactable consumer reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had an appointment tomorrow (17Feb2021) for the 2nd dose but she tested positive on 08Feb2021. The outcome of the events was unknown. The information on the lot/batch number had been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,02/08/2021,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068285,UT,,F,will be having a Wet or Dry macular degeneration procedure; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program. A female patient of an unspecified age received bnt162b2 (BNT162B2) at single dose on 22Feb2021 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 03Feb2021 for Covid-19 immunisation. The patient experienced macular degeneration on an unknown date and she will be having a wet or dry macular degeneration procedure on 23Feb2021 with outcome of unknown. Patient was kind of worried because they're asking her questions about if she took vaccination these past few weeks before going to hospital. Information on Lot/Batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,,,UNK,,,,,,['Macular degeneration'],2,PFIZER\BIONTECH, 1068286,CA,,F,"his mother was hospitalized due to hip fracture; This is a spontaneous report from a contactable consumer Pfizer-sponsored program. A female patient of an unspecified age received first single dose BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter was asking if he could reschedule his mother's second dose appointment which should've been the day of reporting because his mother was hospitalized due to hip fracture (onset date and hospitalization date not reported). The outcome of event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,['Hip fracture'],1,PFIZER\BIONTECH, 1068287,,69.0,F,"tired; very sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809; expiry date: unknown) via an unspecified route of administration in the left arm, on 11Feb2021 at 14:30 at a single dose, for COVID 19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Facility where vaccine was administered was reported as ""other"". On 12Feb2021, the patient had a very sore arm. The patient was tired the next day (13Feb2021). The patient did not receive treatment for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/11/2021,02/12/2021,1.0,UNK,,,,,,"['Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH, 1068288,SC,84.0,M,"congestion in his chest; real deep coughing; hurting at the base of his neck/his shoulders were hurting from his neck down his arms to his elbow; dysentery; felt a little unwell; when he gets up, his back is giving him trouble; he can't stand up long because of the weakness; body also seemed to want to walk backward on his heels when he stands up and he is wanting to fall; he can't stand up that well; his head was hurting in the back of it; his shoulders were hurting from his neck down his arms to his elbow; his shoulders were hurting from his neck down his arms to his elbow; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 04Feb2021 (at the age of 84 years old) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported he came home after getting his shot, and he felt a little unwell but it was no too bad (04Feb2021). Then, on 11Feb2021, he started having dysentery. On 12Feb2021, he got congestion in his chest and a real deep coughing, and then he started hurting at the base of his neck. The patient used a chest rub which helped break up some of the congestion, but he is still coughing. On unspecified date in Feb2021, the patient also experienced his head was hurting in the back of it, and his shoulders were hurting from his neck down his arms to his elbow; his shoulders had been hurting so bad, he thought they would come off. Now (Feb2021), when he gets up, his back is giving him trouble, and he can't stand up long because of the weakness. His body also seemed to want to walk backward on his heels when he stands up and he is wanting to fall (Feb2021). The patient has been taking his dog out every morning, but it is hard to do that now because he can't stand up that well (Feb2021). Therapeutic measure was taken as a result of the event congestion in his chest. Outcome of the event real deep coughing was not recovered while outcome of all the other events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/01/2021,,UNK,,,,,,"['Arthralgia', 'Asthenia', 'Balance disorder', 'Cough', 'Dysentery', 'Headache', 'Malaise', 'Musculoskeletal discomfort', 'Neck pain', 'Pain in extremity', 'Respiratory tract congestion', 'Vertigo']",1,PFIZER\BIONTECH, 1068289,,,F,"Very sore arm at the injection site; She had to lay down and sleep for a hour because of being very tired; Achy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for an unspecified indication. The patient medical history and concomitant medications were not reported. This patient received the Pfizer COVID-19 Vaccine 18 days ago, yesterday was day 18 or day 19 she guessed; and she had a very sore arm at the injection site again, which she had for about 1.5 days when she got the Pfizer COVID-19 Vaccine. She got very tired and achy. She had to lay down and sleep for an hour because of being very tired. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Fatigue', 'Pain', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1068291,IL,69.0,F,"Complete left sided deafness; This is a spontaneous report from a contactable physician. A 69-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular, on 29Jan2021, at single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension and diverticulitis. Patient had no known allergies. Concomitant medications included several prescription medications. Patient did not receive other vaccine in four weeks. The patient experienced complete left sided deafness (disability, medically significant) on 29Jan2021 with outcome of not recovered. Therapeutic measures were taken as a result of the event and included treatment with steroids. The event required physician office visit. The reporting physician could not say that the vaccine definitely caused the event. But as the event happened shortly after the vaccine, the physician felt that it was reportable. The patient was not tested for COVID-19 after vaccination. The information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event deafness unilateral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/29/2021,01/29/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Diverticulitis; Hypertension; Type 2 diabetes mellitus,,,['Deafness unilateral'],1,PFIZER\BIONTECH,OT 1068292,,67.0,U,"Angio-edema; Bottom lip locked badly; This is a spontaneous report from a contactable consumer (patient). A 67-year-old patient of an unspecified gender received the 2nd dose of bnt162b2 (BNT162B2, lot # E19267) at single dose on 12Feb2021 for Covid-19 immunisation, as work in healthcare on the operational side (not clinical). Medical history included blood pressure high. Concomitant medication included levothyroxine (LEVOTHYROXINE), nebivolol hydrochloride (BYSTOLIC), nifedipine (NIFEDIPINE), azilsartan kamedoxomil (EDARBI). On 13Feb2021 the patient had to go directly to the emergency room because the bottom lip locked badly and they called (incomplete sentence), they said it was angio-edema and it was due to the injection. Patient went through a ton of lab work. All blood work and everything were fine, everything was perfect. All the last blood work patient had probably the last one was 26Jan2021, investigation: unknown results. The outcome of events was unknown. Patient wished to know if he/she could take vaccine ever again. That's a little scary, patient did not want to end up in a hospital, that he/she did.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/13/2021,1.0,UNK,LEVOTHYROXINE; BYSTOLIC; NIFEDIPINE; EDARBI,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Angioedema', 'Blood test', 'Investigation', 'Lip oedema']",2,PFIZER\BIONTECH, 1068293,,70.0,M,"severe hypoglycemic event (POC=38)/hypoglycemia; chest pain; He was found driving the wrong way down the highway; no memory of the event; This is a spontaneous report from a non-contactable pharmacist. A 70-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9265) intramuscular, on 01Feb2021 at 08:00 (at the age of 70 years old), for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 01Feb2021, after vaccination, the patient experienced severe hypoglycemic event (POC=38)/hypoglycemia and chest pain. He was found driving the wrong way down the highway with no memory of the event, once stopped by authorities. He was admitted to the hospital with hypoglycemia and chest pain. His home diabetes coverage was an insulin pump and there was denial of decreased PO intake. The insulin pump was stopped once the patient was admitted. His glucose improved and insulin regular SSI was initiated. He was brought for cardiac cath on 02Feb2021 with no new issues seen. The patient was stabilized, was set for follow-up with PCP and endocrinologist and discharged on 04Feb2021. The events resolved on an unspecified date in Feb2021. No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/01/2021,02/01/2021,0.0,PVT,,,,,,"['Amnesia', 'Blood glucose', 'Chest pain', 'Hypoglycaemia', 'Impaired driving ability']",1,PFIZER\BIONTECH,OT 1068294,FL,,U,"tested for Covid 19 IgG and IgM antibodies, and the result was negative; This is a spontaneous report from a contactable Physician. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient tested for COVID 19 IGG and IGM antibodies, and the result was negative. The physician reported that the patient, after 2 doses of the covid vaccine the patient decided a month after to get a blood test, it was at a commercial lab, and tested for Covid 19 IgG and IgM antibodies, and the result was negative. The physician stated that it could be possible that the specific antibody was not part of the testing panel or if this is a concern that immunity was not generated with the vaccine. The patient was concern that immunity was not generated with the vaccine. The patient had tests and procedures which included blood test: Negative a month after to get a blood test/ and tested for Covid 19 IgG and IgM antibodies, the result was negative. The clinical outcome of tested for COVID 19 IGG and IGM antibodies, and the result was negative was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Blood test', 'SARS-CoV-2 antibody test negative']",2,PFIZER\BIONTECH, 1068295,OK,,F,"Was admitted and tested positive and put on ventilator; She felt slightly ill the day of vaccine; 2 days later patient become ill; tested negative 2 times over the following 10 day while deteriorating; Patient died 10 days later; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative. This consumer (daughter) was reported for a female patient (mother). A 76-year-old female patient received first dose of bnt162b2 (Pfizer), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included lupus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient with lupus received 1st dose of vaccine. She felt slightly ill the day of vaccine. 2 days later patient become ill, tested negative 2 times over the following 10 day while deteriorating. Was admitted and tested positive and put on ventilator. Patient died 10 days later. Daughter thought she had COVID before vaccination. Event took place after use of product. The patient underwent lab tests and procedures which included COVID-19: negative (tested negative 2 times over the following 10 day while deteriorating), COVID-19: positive (Was admitted and tested positive and put on ventilator) all on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Patient died 10 days later",Yes,,Not Reported,Yes,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: Lupus syndrome,,,"['COVID-19', 'Condition aggravated', 'Death', 'Illness', 'Malaise', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068296,MO,80.0,F,"Chills; Fever; aches and pains; no appetite; felt weak as a kitten; injection site got swollen; having pain where the injection occurred; she had felt like she was at death's door; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose on BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN6200) solution for injection, via an unspecified route of administration in right arm on 15Feb2021 at a single dose for Covid-19 immunization. Medical history included allergies, hip surgery, and foot surgery three times. Concomitant medications included unspecified medications. Patient reported she has been so sick. She got the shot on Monday 15Feb2021, and that same day she got so sick, it was horrible. Patient had chills, fever, aches and pains, and if someone named it, it was there. She stated that before Monday she was 183 pounds, didn't know if it has changed as she has not been on a scale, but she was sure it has because hasn't eaten since Monday, as she has had no appetite. Her appointment was at 07:45, and she went right when she got up, so she did not really have anything to eat on Monday. Patient stated that on Tuesday, she did not eat anything until the evening when she had one piece of pizza. Today, patient has only had a yogurt. Today was the first time she has gotten out of bed and even felt like getting dressed and putting her contacts in, since Monday. The last few days, patient stated that after getting up and going to the bathroom she would walk downstairs and felt weak as a kitten (15Jan2021). Patient stated that she was at least 80% better, because she had felt like she was at death's door (Feb2021), and she was not a wimp, it was just horrible. Patient mentioned that she was on a lot of medicine, probably 10, but this was the first time she was receiving this vaccine. She stated that she was still having pain where the injection occurred (Feb2021), like when her shirt touches it, she can tell it was there. But patient stated that she had the nicest nurse and the injection itself did not hurt, it was just later, and the injection site got swollen (Feb2021). Outcome of the event she had felt like she was at death's door, chills, fever, aches and pains, felt weak as a kitten was recovering; no appetite was not recovered; while the other events was unknown. No follow-up activities are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Allergy; Foot surgery; Hip surgery,,,"['Asthenia', 'Chills', 'Decreased appetite', 'Near death experience', 'Pain', 'Pyrexia', 'Vaccination site pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 1068299,GA,,M,"bleeding stomach in the lower abdomen; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's wife) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The wife was asking for her husband who will get the second dose of the Covid-19 vaccine on 18Feb2021 however the husband had recent surgery and a bleeding stomach in the lower abdomen on an unspecified date. The wife wants to know if the husband can take the second shot of the vaccine after getting the surgery. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Gastric haemorrhage'],1,PFIZER\BIONTECH, 1068300,RI,74.0,F,"Acute pericarditis; Atrial arrhythmia; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on left arm, on 17Feb2021 10:45 (at the age of 74-year-old, not pregnant), at single dose, for Covid 19 (COVID-19 immunization). Medical history included allergies to alpha antibiotics. No COVID prior vaccination. Concomitant medications included atorvastatin, and bupropion. No other vaccine in four weeks. The patient previously took codeine and experienced allergies. The patient experienced acute pericarditis and atrial arrhythmia, both on 20Feb2021 15:00. Events resulted in emergency room/department or urgent care, and hospitalization (for 1 day). The patient underwent lab tests included COVID test (Nasal Swab/COVID 19 PCR) post vaccination on 21Feb2021, result was negative. Therapeutic measures were taken as a result of events and included treatment with multiple. The outcome of the events was recovering.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/17/2021,02/20/2021,3.0,PVT,ATORVASTATIN; BUPROPION,,Medical History/Concurrent Conditions: Allergic reaction to antibiotics,,,"['Arrhythmia supraventricular', 'Pericarditis', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1068302,NJ,29.0,M,"blacked out and loss consciousness twice; hit head and make a gauche on eyebrow needing stiches; hit head and make a gauche on eyebrow needing stiches; whole body was feverishly hot; This is a spontaneous report from a non-contactable consumer (patient). A 29-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201), via an unspecified route of administration on 13Feb2021 10:30 (at 29-years-old) at single dose (Left arm) for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), on 23Jan2021 03:30 PM (at 29-years-old) on Left arm for COVID-19 immunization. Facility type vaccine was reported as Other. There were no other vaccine administered in four weeks. There were no other medications in two weeks. Approximately 12-24 hours after second dose, whole body was feverishly hot, blacked out and loss consciousness twice within 30mins of each other waking up on the floor from standing position, causing to hit head and make a gauche on eyebrow needing stiches. Events started on 14Feb2021 04:00. Events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of hit head and make a gauche on eyebrow needing stiches. The outcome of the events was recovering. No follow-up attempts are possible. No further information expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/14/2021,1.0,UNK,,,,,,"['Face injury', 'Feeling hot', 'Head injury', 'Loss of consciousness']",2,PFIZER\BIONTECH, 1068304,CT,,M,"died; This is a spontaneous report from a contactable consumer reporting for a patient. An 86-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 10Feb2021 at single dose for COVID-19 immunization. Concomitant medications were not reported. Relevant medical history included bacterial infection, the patient was being treated for bacterial infection and had spent 1 week in hospital within one month prior to being dosed with vaccine. On 17Feb2021 the patient died. The cause of death was unknown. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: death",Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/17/2021,7.0,UNK,,,Medical History/Concurrent Conditions: Bacterial infection (Patient was being treated for bacterial infection and had spent 1 week in hospital within one month prior to being dosed with vaccine.),,,['Death'],1,PFIZER\BIONTECH, 1068305,IL,39.0,F,"Tachycardic, hr 112; hives on both arms, chest, face.; Lips were tingly; This is a spontaneous report from a contactable other hcp. A 39-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 16:00 at single dose, right arm for covid-19 immunization. Medical history included Anti Myelin oligodendrocyte glycoprotein(MOG) disease. Known allergies included prednisone, methyl prednisolone. Concomitant medication included cyclobenzaprine, celecoxib and duloxetine hydrochloride (CYMBALTA). There were no other vaccine in four weeks. The patient previously received first dose of bnt162b2 for covid-19 immunization. The patient had hives on both arms, chest, face. Lips were tingly. Tachycardic, HR 112. The patient took 75 mg diphenhydramine hydrochloride(BENADRYL) and became slightly better. Adverse events start date was 25Feb2021 16:30. Events resulted in [Life threatening illness (immediate risk of death from the event)]. The outcome of the events were recovering. The patient had no COVID prior vaccination. There was no COVID tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/25/2021,02/25/2021,0.0,PHM,CYCLOBENZAPRINE; CELECOXIB; CYMBALTA,,Medical History/Concurrent Conditions: Anti-myelin-associated glycoprotein associated polyneuropathy,,,"['Heart rate', 'Paraesthesia oral', 'Tachycardia', 'Urticaria']",2,PFIZER\BIONTECH, 1068306,,,M,"heart attacks; Collapse of lung; pulse was in the 130s/140s; passed away; nose and fingers turned gray and were cold to the touch; nose and fingers turned gray and were cold to the touch; his big toe had turned gray; his right foot was swollen; low grade fever; Shaking; extremely cold; This is a spontaneous report from a contactable consumer. An elderly male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 18Feb2021, at single dose, for COVID-19 immunisation. Medical history included ongoing blood magnesium decreased (went to the hospital on 17Feb2021). Concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), on 27Jan2021, for COVID-19 immunisation and experienced arm soreness. The patient experienced passed away (death, hospitalization, medically significant) on 23Feb2021, heart attacks (caused hospitalization, medically significant) on 20Feb2021 with outcome of unknown, collapse of lung (caused hospitalization) on 20Feb2021 with outcome of unknown, pulse was in the 130s/140s (caused hospitalization) on 19Feb2021 with outcome of unknown, low grade fever on 18Feb2021 with outcome of recovered on 23Feb2021, shaking on 18Feb2021 with outcome of unknown, extremely cold on 18Feb2021 with outcome of unknown, nose and fingers turned gray and were cold to the touch on 19Feb2021 with outcome of unknown, his big toe had turned gray on 19Feb2021 with outcome of unknown, his right foot was swollen on 19Feb2021 with outcome of unknown. The events his big toe had turned gray and his right foot was swollen required physician visit on 19Feb2021. They were reported as a result of the magnesium deficiency. On 19Feb2021 evening his fever increased and his nose and fingers turned gray and were cold to the touch. On 20Feb2021 he collapsed at home and was taken to the hospital by ambulance. He had several heart attacks prior to the collapse. They decided to put him in a medically induced coma and reduce his body temperature that evening and started dialysis on 21Feb2021. They returned his body to normal temperature on 23Feb2021, his pulse was in the 130s/140s. They were starting to reduce the sedatives on 23Feb2021. The patient passed away on 23Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: passed away",Yes,02/23/2021,Not Reported,Yes,,Not Reported,N,02/18/2021,02/18/2021,0.0,UNK,,Magnesium low (went to the hospital on 17Feb2021),,,,"['Blue toe syndrome', 'Body temperature', 'Death', 'Feeling cold', 'Heart rate', 'Heart rate increased', 'Myocardial infarction', 'Nasopharyngitis', 'Peripheral swelling', 'Pneumothorax', 'Pyrexia', 'Skin discolouration', 'Tremor']",2,PFIZER\BIONTECH, 1068307,,,U,"died; bled out; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had bled out on an unspecified date with outcome of unknown. The patient died on an unspecified date. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: The limited information provided precludes a full clinical assessment of the case. As a cautionary measure and for reporting purposes, and assuming a drug-event temporal association, the Company cannot completely exclude a causal association between the reported events 'bled out' and 'died' (death of unknown cause) and BNT162B2 administration, until sufficient information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021210582 Same reporter/drug, different patient; Reported Cause(s) of Death: died",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Death', 'Haemorrhage']",UNK,PFIZER\BIONTECH, 1068308,MO,75.0,M,"cardiac arrest due to pericardial effusion; cardiac arrest due to pericardial effusion; On 21Feb he went to the ER after vomiting and passing out; On 21Feb he went to the ER after vomiting and passing out; On 19Feb, he began to feel ill again with a fever. He felt worse on 20Feb; On 19Feb, he began to feel ill again with a fever. He felt worse on 20Feb; fever; headache; stomach upset; This is a spontaneous report from a contactable consumer reporting for the father: A 75-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EL3428) at single dose at left arm on 03Feb2021 for Covid-19 immunisation. Medical history included type 2 diabetes mellitus. No known allergies. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included amitriptyline hydrochloride (manufacturer unknown) 10 mg, atorvastatin (manufacturer unknown) 20 mg, dutasteride (manufacturer unknown) 0.5 mg, linaclotide (LINZESS) 290 mcg, gabapentin (manufacturer unknown) 300 mg, montelukast (manufacturer unknown) 10 mg, ramipril (manufacturer unknown) 5 mg, insulin degludec (TRESIBA) 100 unit/ml, liraglutide (VICTOZA) 18 mg/3ml solution. No other vaccine in 4 weeks. The patient experienced cardiac arrest due to pericardial effusion on 21Feb2021 14:15, fever on 13Feb2021, headache on 13Feb2021, stomach upset on 13Feb2021, on 19feb, he began to feel ill again with a fever, he felt worse on 20feb on 19Feb2021, on 21feb he went to the ER after vomiting and passing out on 21Feb2021. Events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of cardiac arrest due to pericardial effusion. Course of events: In Feb2021, 10 days after his 1st injection, the patient developed fever, headache, and stomach upset. He went for a rapid Covid-19 test (nasal swab) and it was negative on 11Feb2021. The doctor told him he might be having a delayed reaction to the vaccination. After a couple of days, he improved. On 19Feb2021, he began to feel ill again with a fever. He felt worse on 20Feb2021. On 21Feb2021 he went to the ER after vomiting and passing out and received treatment: IV fluids, diagnostic testing at ER. Rapid Covid test (nasal swab) at ER came back negative again on 21Feb2021. His heart arrested suddenly and he could not be resuscitated. CT scan results, that came back after death, showed Covid like pneumonia and pericardial effusion. The patient died on 21Feb2021 14:15. Cause of death was cardiac arrest due to pericardial effusion. An autopsy was not performed. The outcome of cardiac arrest due to pericardial effusion was fatal, of fever, headache, stomach upset was recovering, of he began to feel ill again with a fever, he felt worse was not recovered, of he went to the ER after vomiting and passing out was unknown.; Reported Cause(s) of Death: cardiac arrest due to pericardial effusion; cardiac arrest due to pericardial effusion",Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/13/2021,10.0,UNK,AMITRIPTYLINE HYDROCHLORIDE; ATORVASTATIN; DUTASTERIDE; LINZESS; GABAPENTIN; MONTELUKAST; RAMIPRIL; TRESIBA; VICTOZA,,Medical History/Concurrent Conditions: Type 2 diabetes mellitus,,,"['Abdominal discomfort', 'Cardiac arrest', 'Computerised tomogram', 'Condition aggravated', 'Headache', 'Loss of consciousness', 'Malaise', 'Pericardial effusion', 'Pyrexia', 'SARS-CoV-2 antibody test', 'Vomiting']",1,PFIZER\BIONTECH, 1068354,,,M,"Transient Global Amnesia; A spontaneous report was received from a physician concerning himself, a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Transient Global Amnesia. The patient's medical history was not provided. No relevant concomitant medications were reported. On 07-Jan-2021, prior to the onset of the event, the patient received a dose of mRNA-1273 (Batch number: 011J20A) for prophylaxis of COVID-19 infection. On 09-Jan-2021, the patient experienced the event Transient Global Amnesia(Medically Significant) which lasted for 8 hours. Laboratory details provided were CAT scan, Echocardiogram and various other workups Treatment for the event Transient Global Amnesia reported was evaluation at a hospital with a CAT scan, Echocardiogram and various other workups. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event Transient Global Amnesia was reported recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/09/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical History not provided),,,['Transient global amnesia'],1,MODERNA,OT 1068355,,45.0,F,"Hives; Nausea; A spontaneous report was received from a non HCP concerning a 45-Year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives and nausea. The patient was reported with an history of Anaphylaxis in the past. No relevant concomitant medications were reported. On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 11 Jan 2021, The patient experienced Urticaria (Hives) and Nausea with seriousness criteria of Hospitalization. Laboratory details are not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event is unknown.; Reporter's Comments: This case concerns a 45-year-old female, with medical history of anaphylaxis, was hospitalized with serious unexpected events of urticaria and nausea. The events occurred the same day as the first dose of mRNA-1273. Treated with Benadryl. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/11/2021,01/11/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Anaphylaxis,,,"['Nausea', 'Urticaria']",1,MODERNA,OT 1068356,IA,,M,"Pneumonia; A spontaneous report was received from a consumer, concerning herself, a 87-year-old, male patient who Moderna's COVID-19 Vaccine (mRNA-1273) and developed pneumonia. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 24 JAN 2021, approximately 1 day prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch number:0138) intramuscularly for prophylaxis of COVID-19 infection. On 25 JAN 2021, approximately 1 day after receiving the vaccine, the patient went to the emergency room for pneumonia, fever, cough, where in patient could not stop coughing hence he was hospitalized on an unspecified date in 2021. The event pneumonia was also considered to be medically significant. Patient would like to know if he can receive the second vaccine shot scheduled for 20 FEB 2021 and if he can receive the shingles vaccine because he has not yet received it. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event, pneumonia was considered unknown at the time of this report.; Reporter's Comments: This case concerns an 87 year old male patient, who experienced a serious unexpected event of Pneumonia, 1 day after receiving first dose mRNA- 1273 (Lot# 0138). Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/24/2021,01/25/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Pneumonia'],1,MODERNA,OT 1068357,IL,84.0,M,"No pulse and no heart beat; couldn't wake him up; passed away; A spontaneous report was received from a daughter concerning a 84-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced no pulse or heartbeat, couldn't wake him up and passed away. The patient's medical history, as provided by the reporter, included high blood pressure and prostate cancer. No relevant concomitant medications were reported. On 19 Jan 2021, the patient had a blood pressure reading of 133/84 at a cardiology visit. On 13 Feb 2021, approximately 3 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number 031M20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 Feb 2021 at 3:30 pm, the patient could not be woken up and was found with no pulse or heartbeat. Action taken with the drug in response to the events was not applicable. The outcome of the events, no pulse or heartbeat and couldn't wake him up, were not provided. The patient died on 13 Feb 2021. The cause of death was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. The patient's medical history of high blood pressure and prostate cancer remains the risk factors. The cause of death was unknown. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death",Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/13/2021,0.0,UNK,,Hypertension,Medical History/Concurrent Conditions: Prostate cancer,,,"['Blood pressure measurement', 'Cardiac arrest', 'Death', 'Unresponsive to stimuli']",1,MODERNA,OT 1068358,PA,91.0,M,"Belligerent; scatter-brained; Erratic; Delusional; A spontaneous report was received on 16FEB2021 from a caregiver concerning a 91-years-old, male patient who received second dose of Moderna's COVID-19 vaccine and became belligerent, delusional, erratic and scatter-brained. The patient's medical history, as reported by the consumer, include Myasthenia gravis (MG). Relevant concomitant medications reported included prednisone 10 mg, nortriptyline HCL 10 mg caps QD, tamsulosin HCL 0.4 mg caps BID, lisinopril 5 mg QD, gabapentin 200 mg QD night, pyridostigmine 90 mg TID, xanax 25 mg as needed, lexapro 5mg QD, levothyroxine 50 mcg QD, amiodarone HCL 200mg QD, carvedilol 6.25 mg BID. He had been on prednisone 20 mg for 6 weeks and they dropped it to 10mg a week before he received his first vaccine. Patient was taking prednisone for Myasthenia Gravis. On 06JAN2021, patient received their first of two planned doses of mRNA-1273(BATCH/LOT # 012L20A) injection intramuscularly for the prophylaxis of COVID-19 infection. On 09FEB2021, patient received their second of two planned doses of mRNA-1273(BATCH/LOT # 007M208) intramuscularly for the prophylaxis of COVID-19 infection. After receiving second dose of vaccine, patient became belligerent, erratic and scatter-brained. He has no history of dementia. On 16FEB2021 at 3:30am, patient called 911 for a foot fungus and paramedics took him to the hospital. The caregiver stated that he was delusional. Treatment for the events were not provided. The outcome of the events, belligerent, delusional, erratic and scatter-brained, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/06/2021,02/16/2021,41.0,UNK,PREDNISONE; NORTRIPTYLINE HCL; TAMSULOSIN HCL; LISINOPRIL; GABAPENTIN; PYRIDOSTIGMINE; XANAX; LEXAPRO; LEVOTHYROXINE; AMIODARONE; CARVEDILOL,,Medical History/Concurrent Conditions: Myasthenia gravis,,,"['Behaviour disorder', 'Belligerence', 'Delusion', 'Thinking abnormal']",1,MODERNA,OT 1068359,PA,,F,"COVID pneumonia; A spontaneous report was received from a 78-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced COVID pneumonia. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 032L20A) for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient developed COVID pneumonia. She was hospitalized from 22 Jan to 27 Jan 2021. The patient received antibiotic and steroid medications at the hospital. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, COVID pneumonia, was considered resolved on 27 Jan 2021.; Reporter's Comments: Based on the current available information, mRNA -1273 does not contain a virus.The onset of COVID-19 pneumonia on the same day the patient received the vaccine makes the assessment of the event unlikely related to mRNA-1273.",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,01/22/2021,01/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['COVID-19 pneumonia'],1,MODERNA,OT 1068360,FL,83.0,F,"Red streak on inner side of left arm; Felt was going to die; General malaise; Weakness; Slight dizziness; Nausea; Vomited; Blood pressure fluctuation; Hives on inner arms; A spontaneous report was received from a consumer and physician concerning a 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt was going to die, general malaise, red streak on inner side of left arm, hives on inner arms, weakness, dizziness, blood pressure fluctuating, nausea and vomited. The patient's medical history included breast cancer, breast cancer surgery and hives. Concomitant product use was not provided. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot #: 039K20A) (route of administration not specified) in the right arm for prophylaxis of COVID-19 infection. On 17 Jan 2021, 12 to 13 days after the vaccination, the patient developed hives on inner arms which would come and go, appearing in the morning and disappearing during daytime. Patient took Benadryl for it and applied cortisone cream. On 26 Jan 2021, after taking a walk, the patient experienced weakness, slight dizziness, and nausea. Patient was taken to the emergency room (ER) and vomited. The patient was sent home the same day but the patient's blood pressure was noted to be fluctuating. On 27 Jan 2021, the patient ""felt that she was going to die"" and had general malaise. The patient was brought to the ER of another hospital but again was sent home. On 29 Jan 2021, with the symptoms still ongoing and a red streak noted on the inner side of the left arm, the patient was admitted for observation at the second hospital. Laboratory details included Blood works and radiologic tests were done with normal results. The patient's blood pressure was stabilized but patient was still experiencing malaise and still had the on and off rash on both inner arms. Treatment information included Benadryl and Cortisone Cream for the indication hives. Action taken with mRNA-1273 in response to the events was not reported. The event, blood pressure fluctuation, was considered resolved/recovered on 01 Feb 2021. The outcome of the events, hives on inner arms, red streak on inner side of left arm, weakness, dizziness, nausea, vomited, felt was going to die and general malaise, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. This case concerns an 83-year-old female hospitalized with serious unexpected malaise, erythema, anxiety, and NS unexpected urticaria, asthenia, dizziness, BP fluctuation and NS expected nausea, vomiting. Event onset 23 days after the first dose of mRNA-1273. BP changes resolved, other events unknown. As above, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/05/2021,01/17/2021,12.0,PVT,,,Medical History/Concurrent Conditions: Breast cancer; Hives (History of hives three times previously in her life.); Surgery (Breast cancer surgery.),,,"['Anxiety', 'Asthenia', 'Blood pressure fluctuation', 'Dizziness', 'Erythema', 'Malaise', 'Nausea', 'Urticaria', 'Vomiting']",1,MODERNA,OT 1068361,MN,,F,"17 year old female who received her first dose of the Moderna COVID-19 vaccine by accident; A spontaneous report was received from a parent concerning their 17 years-old female daughter, who received Moderna's COVID-19 vaccine (mRNA-1273) which resulted in the event: 17 year old received first dose of the Moderna COVID-19 vaccine by accident/ Product administered to patient of inappropriate age. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly for prophylaxis of COVID-19 infection. On 28 Dec 2020, the Moderna COVID vaccine was given to a 17- year old patient. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, 17 year old received first dose of the Moderna COVID-19 vaccine by accident, was recovered on 28 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273. There were no reported adverse events associated with this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/28/2020,12/28/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1068362,TX,,F,"Bell's Palsy; Neck pain and rigidity; Neck pain and rigidity; Pain in the ear; Epiphora; Could not blink; Shoulder soreness; Chills; Fever; A spontaneous report was received from a Consumer and a healthcare professional concerning a � 35 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced facial paralysis, arthralgia, chills, fever, neck pain, nuchal rigidity, ear pain, lacrimation increased and lagophthalmos. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12-Feb-2021, prior to the onset of the events, the patient received their second planned dose of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the same day, the patient experienced shoulder soreness, pain in the ear, chills, fever, neck pain and rigidity, epiphora, couldn't blink and face paralysis. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events was unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events and the administration of the mRNA-1273 vaccine cannot be excluded. The events of arthralgia, chills and fever are consistent with the known safety profile of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/12/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Arthralgia', 'Chills', 'Ear pain', 'Facial paralysis', 'Lacrimation increased', 'Lagophthalmos', 'Neck pain', 'Nuchal rigidity', 'Pyrexia']",2,MODERNA,OT 1068363,CA,,U,"syringe failed and the patient did not receive the full dose; syringe failed and the patient did not receive the full dose; A spontaneous report was received from a nurse concerning a 69-year-old, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced event like syringe failed and the patient did not receive the full dose. The patient's medical history was not provided. Concomitant medications were not reported. The patient received their first of two planned dose of mRNA-1273 on 27-jan-2021. On 27-Jan-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unkown) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient experienced event like syringe failed and the patient did not receive the full dose. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, syringe failed and the patient did not receive the full dose is unknown.; Reporter's Comments: This report refers to a case of a 69-year-old patient of unknown gender who experienced nonserious unexpected events of Syringe issue and Incorrect dose administered for mRNA-1273, lot # unknown, with no associated adverse events. The syringe failed and the patient did not receive the full dose. Event considered resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Incorrect dose administered', 'Syringe issue']",1,MODERNA,OT 1068364,WV,63.0,F,"All hair has fallen out; Heartburn; Nausea feeling; Passed out; Wasn't feeling right after dose; Face was tingling; Burning feeling in head; A spontaneous report was received from a Consumer regarding a � 63Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like passed out, Wasn't feeling right after dose, face was tingling,bBurning feeling in head, devastated about hair loss after 1st dose, Heartburn and Nausea. The patient's medical history was not reported. Relevant concomitant medications were reported like amitriptyline, duloxetine, gabapentin, metformin, Nexium, hydrocodone, potassium, Proair, ropinrole, simvastatin, spironolactone, Topamax, vitamin d, vitamin b12. On 12- Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:030m20a) intramuscularly for prophylaxis of COVID-19 infection. On 12- Feb-2021, the patient experienced the event like Passed out. On an unknown, date the patient experienced events like Wasn't feeling right after dose, Face was tingling, Burning feeling in head, Devastated about hair loss after 1st dose, Heartburn nausea feeling and Nausea. Laboratory details not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events Passed out, Face was tingling is resolved. The outcome of the events Devastated about hair loss after 1st dose is Recovering/Resolving. The outcome of the events like Wasn't feeling right after dose, Burning feeling in head, Heartburn nausea feeling and Nausea are unkown; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events and the administration of the mRNA-1273 cannot be excluded. Nausea is consistent with the known safety profile of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,01/13/2021,,UNK,AMITRIPTYLINE; DULOXETINE; GABAPENTIN; METFORMIN; NEXIUM 1-2-3; HYDROCODONE; POTASSIUM; PROAIR BRONQUIAL; ROPINIROLE; SIMVASTATIN; SPIRONOLACTONE; TOPAMAX; VITAMIN D 2000; VITAMIN B12 & FOLIC ACID,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Alopecia', 'Burning sensation', 'Dyspepsia', 'Feeling abnormal', 'Loss of consciousness', 'Nausea', 'Paraesthesia']",1,MODERNA,OT 1068365,,,U,"when the patient can receive the next dose given that the dose they received is expired; A spontaneous report was received from an Other Health Professional concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and reported that the patient can receive the next dose given that the dose they received is expired. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On an unknown date, it was reported, when the patient can receive the next dose given that the dose they received is expired. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event was not reported.; Reporter's Comments: This report refers to a case of a patient who received Moderna's COVID-19 vaccine (mRNA-1273) (Lot # not provided) and reported that the patient can receive the next dose given that the dose they received is expired. No associated AEs were reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Expired product administered'],1,MODERNA,OT 1068366,CA,68.0,M,"Received the Moderna COVID vaccine past the 6 hours mark; A spontaneous report) was received from a nurse concerning a 68-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received the Moderna COVID vaccine past the 6 hours mark/expired product administered. The patient's medical history was not provided. No concomitant product use was reported. On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 042L20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, a nurse reported a patient received their first dose of the Moderna COVID-19 vaccine after the 6 hour mark. Per the reporter, the patient did not report any side effects. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, received the Moderna COVID vaccine past the 6 hours mark/expired product administered, was considered resolved on 26 Jan 2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # 042L20A) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Expired product administered'],1,MODERNA,OT 1068367,NM,,U,"Second dose of Moderna vaccine administered on day 22; A spontaneous reportwas received from a healthcare professional (medical director) concerning two patients, age and gender not provided, who received Moderna's COVID-19 Vaccine, and who experienced receiving the second dose vaccine on day 22 (Inappropriate schedule of product administration). The patients' medical histories were not provided. Concomitant product use was not provided by the reporter. The patients received their first of two planned doses of mRNA-1273 (Batch number not provided) on 05-JAN-2021 (route of administration unknown). On 27-JAN-2021, the patients received their second of two planned doses of mRNA-1273 (Batch number not provided), route of administration unknown for prophylaxis of COVID-19 infection. A medical directer reported that at one of his facilities, two employees received their first dose of the mRNA-1273 vaccine on 05-JAN-2021. They were supposed to receive their second dose of mRNA-1273 the week of 01-FEB-2021 but got it instead on 27-JAN-2021 (day 22). The reporter questioned if the dose would be effective or would the patients need to be revaccinated. Treatment information was not provided. The patients received both doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The event, second dose of Moderna vaccine administered on day 22, was considered recovered/resolved; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated adverse events. The event occurred when the second dose was administered 23 days after the first dose of mRNA-1273. Event resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/05/2021,01/27/2021,22.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Inappropriate schedule of product administration'],1,MODERNA,OT 1068368,,,F,"She thinks she had Afib; Heart rate went up; Symptoms were similar to when she had COVID; Temperature of 99 degrees; Severe Headache; Very fatigued, which is unlike her; A spontaneous report was received from a Consumer concerning a unknown Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events- severe headache, had a temperature of 99 degrees, was very fatigued, atrial fibrillation, increased heart rate and recurrence of Covid-19 symptoms. The patient's medical history includes Covid-19, she was on a pacemaker. Relevant concomitant medications reported include patient was taking Diltiazem 120 ER. On 26 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced severe headache, had a temperature of 99 degrees, was very fatigued, which was unlike her, she thinks she had atrial fibrillation (seriousness criteria- medically significant) and increased heart rate. She said her symptoms was similar to when she had Covid-19. Patient is on a pacemaker Laboratory details include she had a body temperature of 99 degrees. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events- severe headache, had a temperature of 99 degrees, was very fatigued, atrial fibrillation, increased heart rate and recurrence of Covid-19 symptoms was considered unknown.; Reporter's Comments: This case concerns a 72 year old, female patient, COVID (March 2020) and has a pacemaker, who experienced a serious unexpected event of Atrial fibrillation among others, 1 day after receiving 1st dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,,,UNK,DILTIAZEM,Pacemaker insertion (cardiac) (Patient is on a pacemaker.),Medical History/Concurrent Conditions: COVID-19,,,"['Atrial fibrillation', 'Body temperature', 'Fatigue', 'Headache', 'Heart rate increased', 'Pyrexia', 'Symptom recurrence']",1,MODERNA,OT 1068369,,,U,"16 year old patient accidentally received the moderna covid-19 vaccine; A spontaneous report was received from a HCP concerning a 16-years-old patient of unknown gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a 16-year-old patient accidentally received the Moderna Covid-19 vaccine (Product administered to patient of inappropriate age). The patient's medical history was not reported. No relevant concomitant medications were reported. On unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, the patient experienced product administered to patient of inappropriate age. Laboratory details not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event is unknown.; Reporter's Comments: This case concerns a 16-year-old patient of unknown gender who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1068370,AZ,,F,"not all the solution was injected; A spontaneous report ) was received from a healthcare provider concerning a 19-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the administration of less than 0.5mL of vaccine. The event was reported as: not all the solution was injected. The patient's medical history was not reported. No relevant concomitant medications were reported. On 20-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27-Jan-2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch:041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. While receiving the vaccine, the patient stated that all the solution was not injected. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event vaccine underdose is resolved/recovered.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273, lot # 041L20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/27/2021,28.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Underdose'],2,MODERNA,OT 1068371,MD,50.0,U,"Second Moderna vaccine was injected in wrong location; swollen arm; A spontaneous report was received from a nurse concerning a 50- year-old patient of unknown gender who received Moderna's COVID-19 vaccine (mRNA-1273) and was injected in wrong location (inappropriate route of vaccination) and developed swollen arm(peripheral swelling). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknow date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 JAN 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route not in the deltoid muscle for prophylaxis of COVID-19 infection. On 26 JAN 2021, it was reported that the patient received second Moderna vaccine in an area that may not have been injected in deltoid muscle (injected in wrong location) and developed swollen arm (far back of arm) on the same day. On 28 JAN 2021, the patient consulted an HCP who advised patient to monitor the affected area and prescribed Benadryl, which was not applied. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The event, injected in wrong location (inappropriate route of vaccination) was considered recovered/resolved and the outcome of swollen arm(peripheral swelling) was unknown.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event of peripheral swelling, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No recorded medical history.),,,"['Incorrect route of product administration', 'Peripheral swelling']",2,MODERNA,OT 1068372,,,F,"the vaccine dripped out in my arm and it was on my hand. Then they give me a very small dose about a quarter of a dose in my other arm; the vaccine dripped out in my arm and it was on my hand. Then they give me a very small dose about a quarter of a dose in my other arm; A spontaneous report received from a health care professional concerning, 39-year-old age female patient who received second dose of the Moderna COVID-19 vaccine and vaccine dripped out in my arm and it was on my hand. Then they give me a very small dose about a quarter of dose in my other are. The patient's medical history was not included. Patient's concomitant was not included. On 22 Jan 2021 date, the patient received their second dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: 012L20A) intramuscularly for prophylaxis of COVID-19 infection. Patient stated that she was vaccinated with her second dose of the Moderna COVID-19 vaccine on 22 Jan 2021. Patient stated that the vaccine dripped out of her arm and it was on her hand. Patient stated they then gave her a very small dose about a quarter of a dose in her other arm. Patient wants to know if the dose was enough. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was considered as recovered.; Reporter's Comments: This report refers to a case of 39-year-old female who experienced nonserious unexpected events of Exposure via skin contact and Incomplete dose administered for mRNA-1273, lot # 012L20A with no associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Exposure via skin contact', 'Incorrect dose administered']",2,MODERNA, 1068373,NJ,,F,"Lymph node enlarged at the base of neck near the shoulder; Chills; Nausea; Sore arm; patient received vaccine right below shoulder bone; A spontaneous report was received from a nurse, a 60 year old female patient who received Moderna's COVID-19 mRNA-1273 vaccine at inappropriate site of vaccination and who experienced chills (Chills), nausea (Nausea), sore arm (pain in extremity) and enlarged lymph nodes at base of neck and shoulder (Lymphadenopathy). The patient's medical history included prior dose of Covid-19 vaccination. No adverse event was reported in the medical history of the patient. Concomitant medications were not reported. On 05 Jan 2021, the patient received first of the two planned doses of mRNA-1273 (Batch number:011L20A) for the prophylaxis of Covid-19 infection. No adverse event was reported related to the first dose. On 02 Feb 2021, the prior to the onset of the events, the patient received second of their two planned doses of mRNA-1273 (Lot number:007M20A) at inappropriate site of vaccination (right below the shoulder bone). On 03 Feb 2021,the patient reported to experience chills(Chills), nausea(Nausea), sore arm(pain in extremity) and enlarged lymph nodes at base of neck and shoulder (Lymphadenopathy). Treatment for the events were not reported. The outcome of the event inappropriate site of vaccination was considered to be resolved on 08 Feb 2021. The outcome of the events chills (Chills), nausea (Nausea), sore arm (pain in extremity) and enlarged lymph nodes at base of neck and shoulder (Lymphadenopathy) was considered not resolved.; Reporter's Comments: This case concerns a 60-year-old female who had a nonserious unexpected Product administered at inappropriate site along with nonserious expected pain in extremity, lymphadenopathy, nausea, and chills. Event onset was 1 day after second dose and 29 days after first dose of mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/05/2021,02/02/2021,28.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Chills', 'Lymphadenopathy', 'Nausea', 'Pain in extremity', 'Product administered at inappropriate site']",2,MODERNA,OT 1068374,TX,,M,"Received 2nd dose 18 days after 1st dose; A spontaneous report report was received from pharmacists concerning a male patient (age unknown) who received the 2nd dose of the vaccine 18 days after 1st dose/inappropriate schedule of product. The patient's medical history was not provided. No current illness was reported. Concomitant product use was not provided by the reporter. On 11 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Batch# 007M20A) intramuscularly for prophylaxis of covid-19 infection. On 29 Jan 2021, 18 days following the first dose, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of covid-19 infection. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event is not applicable. The outcome of the event, 2nd dose of the vaccine 18 days after 1st dose, was considered resolved on 29 Jan 2021; Reporter's Comments: This report refers to a case of inappropriate schedule of product for mRNA-1273, Batch # 007M20A with no associated AEs. Causality for the medication error is not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/29/2021,18.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Inappropriate schedule of product administration'],1,MODERNA,OT 1068376,NY,37.0,M,"Chills; fever; nausea; vomiting; body aches/pains; fatigue; This is a spontaneous report from a contactable healthcare professional (patient himself). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), (at the age of 37-years-old) intramuscular in the left arm on 25Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history and allergies to medications, food, or other products/known allergies: were reported none. The patient's concomitant medications were not reported. The vaccine was administered in a hospital. Prior to vaccination, the patient was not diagnosed with COVID-19.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has not received any other medications within 2 weeks of vaccination. On 28Jan2021 at 10:30 AM, the patient experienced chills, fever, nausea, vomiting, body aches/pains, fatigue. The events were considered non-serious. The events resulted in emergency room/ department or urgent care. There was no treatment received for the adverse events. The patient has not been tested for COVID since the vaccination. The outcome of the events was not recovered at the time of report. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/28/2021,3.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Fatigue', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH,OT 1068380,,,F,"Diarrhea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had diarrhea since an unspecified date for two weeks after getting the first dose of Pfizer COVID vaccine. She took a whole bottle of Pepto Bismol. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Diarrhoea'],1,PFIZER\BIONTECH, 1068384,,,F,"Very mild sore arm; This is a spontaneous report from a contactable consumer or (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from 17Jan2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced very mild sore arm on an unspecified date with outcome of unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/17/2021,,,UNK,,,,,,['Pain in extremity'],UNK,PFIZER\BIONTECH, 1068389,AL,37.0,F,"5 minutes after receiving the COVID-19 Vaccine shot, she had generalized itching allover her body; Her heart rate was in the 140s/tachycardia; She noticed the COVID-19 Vaccine injection site had a red welt; She developed a rash on her torso first, and then she developed a rash on her neck and face; Shortness of breath; Allergic reaction; Injection site rash; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL8982, expiry: unknown), via an unspecified route of administration in the left arm on 29Jan2021 14:25 at a single dose for COVID-19 immunization at a hospital. Medical history included asthma from 2001. The patient also had history of anaphylactic reactions to bee stings and strawberries. She said her allergist tested her further and told her she has severe allergies to tomatoes and to not eat tomatoes anymore. She said she has allergies to sulfa antibiotics. She said about 10 years ago was the last time she took a sulfa antibiotic and she had hives. She said her allergist recommended she avoid sulfa antibiotics. Concomitant medication included salbutamol sulfate (PROAIR HFA; lot: DAE36A, expiry: May2021; NDC Number: 59310-5779-22) from 2001 and ongoing for asthma. The patient has no prior vaccinations within 4 weeks. The patient received her first COVID-19 vaccine shot on Friday, 29Jan2021, and had an allergic reaction (Jan2021). 5 minutes after receiving the COVID-19 vaccine shot (29Jan2021 14:30), she had generalized itching all over her body, she then had tachycardia. She was administered some medication by the staff at the site where the COVID-19 vaccine was being administered, but her allergic reaction kept progressing. She developed a rash on her torso first, and then she developed a rash on her neck and face. She then developed shortness of breath. She was brought to the hospital's Emergency Room for further treatment. She was given the oral medications Pepcid 40mg, Claritin (dose unknown), and Benadryl 25mg at the location where the COVID-19 vaccines were being administered. When she started to experience shortness of breath, she used her own personal Albuterol inhaler. When she was in the Emergency Room, she was given a shot of Epinephrine .4ml at 15:16, and a dose of Benadryl 25mg IV at 15:10. She was observed in the Emergency Room for a couple of hours and then discharged. The patient was also given a steroid dose pack for her itching, clarified as Medrol 4mg tablets. She said she is titrating down the amount of Medrol 4mg tablets (NDC Number: 59762-4440-2, Lot Number: DM4008, Expiration Date: Oct2022). The patient reported that her itching has improved, but she still has a rash on her torso. She noticed the COVID-19 vaccine injection site had a red welt first on 29Jan2021, clarifying the vaccine injection site has a rash now (2021). She said she was put on a heart monitor when her allergic reaction began to progress, and her heart rate was in the 140s, clarifying she has a heart rate of 145. She said at the time she was discharged from the Emergency Room; her heart rate was 115. She stated she has had to use her Albuterol inhaler throughout the weekend, which is more so than usual, but it is currently allergy season where she lives in. She had no blood work performed while she was being treated in the Emergency Room but did have an EKG to be on the safe side, along with monitoring of her vital signs. The outcome of the events generalized itching, rash, and shortness of breath was recovering; event tachycardia was recovered on 29Jan2021; event vaccination site rash was not recovered while the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/01/2021,,PVT,PROAIR HFA,,"Medical History/Concurrent Conditions: Anaphylactic reaction; Asthma; Bee sting hypersensitivity; Food allergy; Fruit allergy; Hives (She said about 10 years ago was the last time she took a sulfa antibiotic, and she had�hives.); Sulfonamide allergy (about 10 years ago was the last time she took a sulfa antibiotic)",,,"['Dyspnoea', 'Electrocardiogram', 'Heart rate', 'Hypersensitivity', 'Laboratory test', 'Pruritus', 'Rash', 'Tachycardia', 'Vaccination site rash', 'Vaccination site urticaria', 'Vital signs measurement']",1,PFIZER\BIONTECH, 1068390,MO,64.0,F,"Severe difficulty breathing; difficulty breathing frightened her; This is a spontaneous report from a contactable consumer (patient). A 64 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9262), intramuscular (on the upper left shoulder) on 27Jan2021 09:20 (at the age of 64-year-old), single dose for COVID-19 immunization. Medical history included ongoing hypothyroidism diagnosed about 14 years ago, breast cancer from Dec2017 and ongoing diagnosed in Dec2017, ongoing asthma she was diagnosed with asthma when she was 39 years old, surgery from an unknown date, she had surgery to correct a deviated septum and her asthma got better, she has high blood pressure after all the treatment. Concomitant medication included salbutamol (ALBUTEROL). On 27Jan2021 she had the first injection. It was about 14 to 16 hours after the injection that she had severe difficulty breathing. Reported she has asthma. She was a cancer survivor, and she has high blood pressure after all the treatment. The difficulty breathing woke her out of her sleep. She had to call the doctor since she is concerned about her second dose which is scheduled for 17Feb2021. The difficulty breathing frightened her, and it was not an immediate reaction, she had the shot at 9:30 am (clarifies she received the injection at 09:20 am) and between 1 to 2 am in the night, she woke up not able to breathe. She could not use her inhaler since she could not really breathe in. She was obviously able to get some air in since she did not pass out. She contacted her doctor and he will send her a prescription to get an Epipen, so she has it on hand when she gets her second dose. Her doctor does not want her to not get the second dose. States she is concerned about other asthmatics receiving the vaccine and wanted to call and report this. She expected it to happen onsite where she received the injection but it did not. Her doctor asked her if she thought it was an asthma attack and she told her doctor that she has not felt like this in 24 years. Treatment/Outcome: She stepped out into the cold to shrink her airways and then was able to use her inhaler. Reports it was not a 2 hour episode thank god, and within 15 minutes she was able to force an inhaler dose in. Everything is fine. She is a breast cancer survivor and cannot use her right side so she had the injection on her left side in her upper shoulder, she has to wait 5 years to be considered cancer free. Her doctor suggested to use her albuterol inhaler for 4 days in advance of getting the second dose of the vaccine. She would think that would be abusing her albuterol but she will do that since she was instructed to do so by her doctor. She was terrified. She will have an Epipen on hand when she goes to get her second dose. She understands the symptoms can be worse with the second dose, she is anticipating everything should be fine. The outcome of the event difficulty of breathing was recovered on Jan2021, for the other event was unknown. No additional vaccines administered on same date of the Pfizer Suspect. No AE(s) following prior vaccinations, states she has had everything. No Prior Vaccinations within 4 weeks.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/01/2021,,UNK,ALBUTEROL [SALBUTAMOL],Asthma (she was diagnosed with asthma when she was 39 years old); Breast cancer (diagnosed in Dec2017); Hypothyroidism (diagnosed about 14 years ago),Medical History/Concurrent Conditions: Blood pressure high; Surgery (She had surgery to correct a deviated septum and her asthma got better),,,"['Dyspnoea', 'Fear']",1,PFIZER\BIONTECH,OT 1068391,CA,,F,"Took advil due to her sore arm after shot.; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unspecified), via an unspecified route of administration in the arm on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm. It was reported that patient took Advil due to her sore arm after shot and inquired if that would have an effect on the vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain in extremity'],UNK,PFIZER\BIONTECH, 1068392,,,M,"feels dizzy and woosey; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer, reporting for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine this morning, on an unspecified date in Jan2021, and felt dizzy and woosey - wondering if that was normal. The outcome of the event was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,['Dizziness'],UNK,PFIZER\BIONTECH, 1068394,NJ,,F,"almost faded on the floor a while ago; This is a spontaneous report from a Pfizer Sponsored program Pfizer First Connect from a contactable consumer. A female patient (wife) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose,via an unspecified route of administration on 31Jan2021 14:45 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer's wife received Covid-19 vaccine first shot earlier today at 2:45pm and almost faded on the floor a while ago. Outcome of event was unknown. Information about Lot/Batch Number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/31/2021,01/31/2021,0.0,UNK,,,,,,['Syncope'],1,PFIZER\BIONTECH, 1068395,IL,34.0,F,"Elevated BP 166/99; Nausea; Heart palpitations hr 111; Heart palpitations hr 111; Sweating; Muscle cramps; Swollen lymph nodes; Dizzy; Body weakness; Fatigue; Pain moving across my neck/chest/back; Pain moving across my neck/chest/back; pain moving across my neck/chest/back; Trouble sleeping; Pressure in my chest; Splotchy skin; This is a spontaneous report from a contactable other health professional reporting for herself. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration, on the left arm, on 20Jan2021 at single dose for COVID-19 immunisation. Medical history included sinusitis, placenta accreta, infertility, caesarean section, seasonal allergy, sulfa allergy, and coriander allergy all from an unknown date. The patient did not have COVID-19 prior to vaccination. The patient is not pregnant. Concomitant medication included prednisone from an unspecified date. The patient previously took hydrocodone and experienced drug allergy. The patient previously received the first dose of BNT162B2 (lot number: EL1284) on 30Dec2020 for COVID-19 immunisation and experienced left arm completely numb and tingling for 4 weeks. No other vaccines were given in four weeks. On an unspecified date after the second shot, it was reported that the patient experienced elevated BP of 166/99, nausea, heart palpitations HR 111, sweating, muscle cramps, swollen lymph nodes, dizzy, body weakness, fatigue, pain moving across the neck/chest/back, trouble sleeping, and pressure in chest. On 30Jan2021, 10 days after the second vaccination, the patient experienced splotchy skin. The events resulted in doctor clinic visit and emergency room care. The patient was given an unspecified treatment for the events. The patient was tested for COVID-19 post vaccination via nasal swab on 26Jan2021 with a negative result. The vaccine was administered in the workplace clinic. The outcome of the events were reported as recovering.; Sender's Comments: A causal association between BNT162B2 and the reported elevated blood pressure cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/30/2021,10.0,WRK,PREDNISONE,,Medical History/Concurrent Conditions: C-section; Food allergy; Infertility; Placenta percreta; Seasonal allergy; Sinusitis; Sulfonamide allergy,,,"['Asthenia', 'Back pain', 'Blood pressure increased', 'Blood pressure measurement', 'Chest discomfort', 'Chest pain', 'Dizziness', 'Fatigue', 'Heart rate', 'Heart rate increased', 'Hyperhidrosis', 'Insomnia', 'Lymphadenopathy', 'Muscle spasms', 'Nausea', 'Neck pain', 'Palpitations', 'Rash macular', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1068397,TX,75.0,M,"Coughing blood; I went last Thursday to a COVID testing station and I tested positive; Iron was little bit low; My sugar was a little high that is because I was taking taking a steroid (Unspecified Medication); This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3248), via an unspecified route of administration (on right arm) on Jan2021 (at the age of 75-years-old), single dose for COVID-19 immunization. Medical history included diabetes from an unknown date, bypass (20 years ago). Concomitant medication included apixaban (ELIQUIS), insulin glargine (BASAGLAR). Patient went in for his COVID 'vaccine' (not clear) Shot a week ago and he has a follow up in two more weeks. He went last Thursday to a COVID testing station his wife and him and came back, tested positive. So, he went to my healthcare provider and they gave him some meds (Unspecified Medications) and he was worse than that today. So, he went to the hospital this morning (not clarified further if hospitalized or not), he was coughing up blood and they gave him some medication for that and did some chest x-rays, everything was good. He told his doctor about the COVID Shot another one scheduled in two weeks, the 14th two weeks from today and they recommended that he postpones it for three months. The patient had unspecified lab work done, and showing Iron was little bit low but nothing to be concerned about and his sugar was a little high that is because he was taking taking a steroid (Unspecified Medication). The outcome of the events was unknown.; Sender's Comments: The reported sugar high was due to unspecified concomitant steroid, and was unrelated to the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE).",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,ELIQUIS; BASAGLAR,,Medical History/Concurrent Conditions: Bypass surgery (I had bypass 20 years ago); Diabetes,,,"['Blood glucose', 'Blood glucose increased', 'Blood iron', 'Blood iron decreased', 'Haemoptysis', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive', 'X-ray']",1,PFIZER\BIONTECH, 1068404,FL,74.0,F,"Dizzy; Blurred vision; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246; Expiration date was not reported) on 29Jan2021 (10:45) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the Public Health Department. Medical history included hypertension (HTN), atrial fibrillation (Afib), diabetes mellitus (DM), migraine and sulfa drug allergy. Concomitant medications included dabigatran etexilate mesilate (PRADAXA), metoprolol, montelukast sodium (SINGULAIR) and other unspecified medications. The patient previously took clarithromycin (MACROBID), and had allergies; and had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246; Expiration date was not reported) on 08Jan2021 (when the patient was 74 years old) on the right arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 29Jan2021 (21:00), the patient was dizzy; and had blurred vision. The patient did not receive any treatment for the reported events. The outcome of the events, 'dizzy' and 'blurred vision', was recovering. The patient was diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,PUB,PRADAXA; METOPROLOL; SINGULAIR,,Medical History/Concurrent Conditions: AFib; Diabetes mellitus; Hypertension; Migraine; Sulfonamide allergy,,,"['Dizziness', 'Vision blurred']",2,PFIZER\BIONTECH, 1068405,GA,,F,"Increased heart rate/heart rate increased to 200 beats per minute; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on unspecified date at a single dose in the left arm for covid-19 immunization. Medical history included high blood pressure from 2017 and ongoing, open heart surgery in Aug2017 (for two holes in her heart), complete heart valve replacement in Sep2017 (replaced with pig valve), pacemaker in Oct2017 and ongoing, thyroid condition and allergies. Concomitant medications included metoprolol from unspecified date in 2017 and ongoing for thyroid condition, amlodipine from unspecified date in 2017 and ongoing for high blood pressure and clarithromycin (CLARITIN [CLARITHROMYCIN]) from unspecified date in 2017 and ongoing for allergies. No vaccines administered on the same date or within four weeks prior to administration of bnt162b2. The patient experienced increased heart rate, four to five days following first dose on unspecified date. She was asleep when her heart rate increased to 200 beats per minute around 20:00 which woke her. She did not see it coming. She was seen in the emergency room, but not admitted to the hospital in response to this event. They did not know at that time what caused this event. While in the emergency room, the patient was given intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. She does not know the name of the intravenous medication for cardioversion that she was administered. She recovered completely from this event on unknown date. The patient underwent lab tests and procedures which included: in the emergency room visit, kidneys and heart were tested, x-ray was performed, electrocardiogram (EKG), liver and thyroid tested, all of which came back good; and her heart rhythm was fast, and irregular. Therapeutic measure was taken as a result of the event. Outcome of the event was recovered on unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,SEN,METOPROLOL; AMLODIPINE; CLARITIN [CLARITHROMYCIN],Artificial cardiac pacemaker user; Blood pressure abnormal; Open heart surgery (for two holes in her heart),Medical History/Concurrent Conditions: Allergy (diagnosed allergies); Heart valve replacement (replaced with pig valve); Thyroid disorder,,,"['Electrocardiogram', 'Heart rate', 'Heart rate increased', 'Investigation', 'Liver function test', 'Thyroid function test', 'X-ray']",1,PFIZER\BIONTECH, 1068406,GA,61.0,F,"Increased heart rate following second dose; they took her blood pressure which was 193; she feels a little lightheaded still; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on the left arm shoulder (as reported) on 29Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure from 2017 and ongoing, open heart surgery in Aug2017 (for 2 holes in the heart), complete heart valve replacement in Oct2017 and ongoing, ""pacemaker"" from Oct2017 and ongoing. Concomitant medication included metoprolol for thyroid condition, amlodipine for high blood pressure, clarithromycin (CLARITIN [CLARITHROMYCIN]) for allergies; all from 2017 and ongoing. Patient previously took first dose of BNT16B2 on an unspecified date for COVID-19 immunization and experienced heart rate increased. She was brought to the emergency room and they gave her an intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. Family medical history included mother and sister died from lung cancer; father died of pancreatic cancer. Heart rate increased following second dose of Pfizer-BioNTech COVID-19 vaccine administered on 29Jan2021; onset of event was in the afternoon on 30Jan2021 while at work. Her heart kind of jumped, skipped a beat and then just took off; she could feel her body twerking. Her heart rate went up to 193 beats per minute. She went to the nurses station at work, they took her blood pressure which was 193-verified this as same number of bpm of heart rate-documented as provided. That nurse told her she should go to the hospital, so patient just left work and walked to the hospital which was a block away from work. She did not feel lightheaded, sick, or pain, just heart racing. She was again seen in the emergency room in response to this event, but was not admitted to the hospital. She was again given an intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. She does not know the name of the intravenous medication for cardioversion that she was administered. The only thing still ongoing related to this event was that she feels a little lightheaded still. Relevant Tests: All were good. They tested her kidneys, heart did an X-ray, EKG; tested her liver and thyroid and they said everything came back good; They said her heart rhythm was fast, and irregular, but something else was normal-she does not remember what that was. She had no further details or results for testing/investigations to provide at this time. Outcome of increased heart rate was recovered while outcome of the remaining events was unknown. Information on the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,SEN,METOPROLOL; AMLODIPINE; CLARITIN [CLARITHROMYCIN],Artificial cardiac pacemaker user; Blood pressure high; Cardiac operation (Replaced with pig valve),Medical History/Concurrent Conditions: Open heart surgery (for 2 holes in the heart),,,"['Blood pressure measurement', 'Dizziness', 'Electrocardiogram', 'Heart rate', 'Heart rate increased', 'Hypertension', 'Laboratory test', 'Liver function test', 'Thyroid function test', 'X-ray']",2,PFIZER\BIONTECH, 1068407,CA,67.0,F,"blood pressure went up/blood pressure was 156/81/her blood pressure was 180 over 80 something; This is a spontaneous report from a contactable consumer who reported for herself, a 67-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9263), intramuscular in left arm, on 26Jan2021 at 11:00, at the age of 67 years, at a single dose for COVID-19 immunization. Medical history included ongoing high cholesterol, ongoing high blood pressure, and eyeglasses wearer. Ongoing concomitant medications included nebivolol hydrochloride (BYSTOLIC Tablet) for high blood pressure, bumetanide tablet taken as diuretic, rosuvastatin calcium (ROSUVASTIN Tablet) for high cholesterol, and acetylsalicylic acid (BABY ASPIRIN Tablet) to keep healthy. The patient reported that her blood pressure went up and is still up since last Tuesday (as reported). She received the first dose of the COVID vaccine at 11 am. She was okay until that evening around 5 pm, her blood pressure started going up, her blood pressure shot up. She called her doctor. Her doctor and her did not know if her blood pressure going up could be from the vaccine. Her doctor told her to take more of her already prescribed blood pressure medication. The next day, she went to see her doctor due to blood pressure still being high and he gave her more blood pressure medications. Her doctor prescribed a different kind of blood pressure medication to take along with her existing blood pressure medication (BYSTOLIC). She is concerned and asked if her elevated blood pressure will go back to normal, her blood pressure is still high. Her doctor told her when someone has a reaction to a vaccine, it usually takes days or up to two weeks to recover from the reaction. Her blood pressure is still high and her doctor is puzzled and prescribed her more medications to control her blood pressure. Today, 01Feb2021, at the doctors office her blood pressure was 156/81. Yesterday, 31Jan2021, her blood pressure was 180 over 80 something. She puts her glasses on to read the card. Patient would like to know how long will her symptoms last and if she is going to die from this. She is getting nervous and requests to be transferred to address her question. She thought she was the first person this has happened to but she read online that one person has had the same symptoms with high blood pressure after receiving the vaccine. She had been advising everyone to get the vaccine but now she will advise her family to hold off. The outcome of the event was not recovered.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9263) to reported event Blood pressure increased cannot totally be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,UNK,BYSTOLIC; BUMETANIDE; ROSUVASTIN; BABY ASPIRIN,Blood pressure high; High cholesterol,Medical History/Concurrent Conditions: Eyeglasses wearer,,,"['Blood pressure increased', 'Blood pressure measurement']",1,PFIZER\BIONTECH,OT 1068408,TN,76.0,M,"Bell's Palsy/drooping of his face and mouth; Bloody nose; vertigo (dizzy / lightheaded); vertigo (dizzy / lightheaded); swallowing issues; Chewing issues; weak; tired / does not have stamina; This is a spontaneous report from a contactable consumer (the patient's wife). A 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9264), via an unspecified route of administration in the right arm on 09Feb2021 at 12:30 (at the age of 76-years-old) as a single dose for COVID-19 immunization. Medical history included vertigo (before the 2nd dose all the time), diabetic type 2 due to exposure to Agent Orange, stent in Dec2019, sulfa allergies, blood pressure abnormal. Concomitant medications included metformin, buspirone, sitagliptin phosphate (JANUVIA), hyoscyamine sulfate (OSCIMIN), doxepin, lisinopril for blood pressure, silodosin, simvastatin (ZOCOR), exenatide (BYDUREON) for diabetes, fish oil, zinc tablet in the morning, ubidecarenone (COQ-10), vitamin D3, cyanocobalamin (VIT B12), allium sativum bulb (GARLIC EXTRACT), ascorbic acid/ betacarotene/ biotin/ calcium/ chloride/ chromium/ copper/ folic acid/ iodine/ lycopene/ magnesium/ manganese/ molybdenum/ nickel/ nicotinic acid/ pantothenic acid/ phosphorus/ potassium/ pyridoxine hydrochloride/ riboflavin/ selenium/ silicon/ thiamine/ vanadium/ vitamin b12 nos/ vitamin d nos/ vitamin e nos/ vitamin k nos/ xantofyl/ zinc (CENTRUM SILVER FOR MEN 50+). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247) on 23Jan2021 at 10:30 (at the age of 76-years-old) in the right arm and experienced pain in arm and fatigue. On 09Feb2021, the patient developed a bloody nose that was unstoppable at home. The reporter took the patient to the emergency room (ER), where his nose was packed, and he was kept overnight. The following day, while his nose was being unpacked, drooping of his face and mouth was observed. Tests for a stroke were negative on Feb2021. The patient was kept in the hospital for three days and was diagnosed with Bell's Palsy on 11Feb2021. The events ""Bell's Palsy/drooping of his face and mouth"" and bloody nose resulted in hospitalization/prolonged hospitalization in Feb2021 for 3 days. The patient's wife reported that as of 09Feb2021, he had swallowing issues when it came to solid foods and was looking for suggestions on what he can eat. The tongue was not swollen, and he was breathing better since the packing had been removed. As of Feb2021, the patient had chewing issues and cannot take solid food. The patient had vertigo before the second vaccination dose all the time, and experienced it again last night on 16Feb2021, he was dizzy and lightheaded. As of an unspecified date in Feb2021, the patient was weak and tired (did not have stamina). The patient was treated for ""Bell's Palsy/drooping of his face and mouth"" with prednisone 20 mg 2 tablets once a day and valacyclovir 500 mg 2 tablets twice a day. The patient was not treated for bloody nose and swallowing issues. The clinical outcome of "" Bell's Palsy/drooping of his face and mouth"", swallowing issues, chewing issues, weak, ""tired / does not have stamina"" was not resolved; bloody nose was resolved on Feb2021; ""vertigo (dizzy / lightheaded)"" was resolved on 17Feb2021.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/09/2021,02/01/2021,,PVT,METFORMIN; BUSPIRONE; JANUVIA [SITAGLIPTIN PHOSPHATE]; OSCIMIN; DOXEPIN; LISINOPRIL; SILODOSIN; ZOCOR; BYDUREON; FISH OIL; ZINC; COQ-10; VITAMIN D3; VIT B12; GARLIC EXTRACT [ALLIUM SATIVUM BULB]; CENTRUM SILVER MEN 50+,,Medical History/Concurrent Conditions: Blood pressure abnormal; Drug allergy; Exposure to toxic agent; Stent placement; Type 2 diabetes mellitus (Due to exposure to Agent Orange in Vietnam); Vertigo (He had vertigo before the 2nd dose all the time.),,,"['Asthenia', 'Disease recurrence', 'Dysphagia', 'Epistaxis', 'Facial paralysis', 'Fatigue', 'Investigation', 'Mastication disorder', 'Vertigo']",2,PFIZER\BIONTECH, 1068409,CA,,F,"Lungs were filled with fluid; couldn't breathe; fatigue; woke up in the middle of the night; couldn't lean back; felt like her lung was on fire; This is a spontaneous report from a Pfizer-sponsored program from a contactable female consumer, the patient. This 62 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 24Jan2021 for COVID-19 vaccination. Medical history was unknown. Concomitant medication sere unknown. On an unknown date, the patient experienced severe adverse reactions after the 1st dose reported as she woke up in the middle of the night and couldn't breathe/difficulty in breathing and lasted for 4 hours, her lungs were filled with fluid and felt like her lung was on fire, couldn't lean back and had fatigue the next day. The clinical outcome of woke up in the middle of the night couldn't breathe/difficulty in breathing, lungs were filled with fluid, felt like her lung was on fire, couldn't lean back and fatigue was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/24/2021,,,UNK,,,,,,"['Dyspnoea', 'Fatigue', 'Middle insomnia', 'Movement disorder', 'Pulmonary oedema', 'Pulmonary pain']",1,PFIZER\BIONTECH, 1068477,CA,67.0,F,upper lip swelling,Not Reported,,Yes,Not Reported,,Not Reported,Y,03/02/2021,03/02/2021,0.0,UNK,,,,,,['Lip swelling'],1,MODERNA,IM 1068549,FL,87.0,F,2/13/21 Patient had covid like symptoms 2/15/21 Patient admitted to Hospital with covid like sx and decreased O2 sat; tested positive for Covid on 2/15/21; treated with Remdesivir and convalesent Plasma. Sx worsened and patient died 2/26/21..,Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/13/2021,3.0,UNK,,,"Obesity, Lung disease, DM type 2, spinal stenosis, OA, essential tremor, sleep apnea, glaucoma, Hashimoto thyroid disease",,,"['COVID-19', 'Death', 'Oxygen saturation decreased', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 1068550,MO,81.0,F,EXTREME HIP PAIN THAT INTERFERES WITH SLEEP AND DAILY LIFE. DOES NOT ABATE WITH TIME.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/23/2021,02/24/2021,1.0,PVT,,,,,,"['Arthralgia', 'Loss of personal independence in daily activities', 'Sleep disorder']",2,MODERNA,SYR 1068564,LA,80.0,M,"On 3/2/2021, clinic was notified by patient's family that patient had deceased on 2/28/2021 from a heart attack. Unsure of any relation to the Moderna vaccine but reporting for due diligence.",Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,02/26/2021,02/28/2021,2.0,PVT,amoxicillin 500mg-potassium clavulanate 125mg tablet; aspirin 81mg; atorvastatin 40mg; carvedilol 12.5mg; clopidogrel 75mg; enalapril maleate 20mg tablet; furosemide 40mg tablet; mupirocin 2% topical ointment; pantoprazole 20mg tablet; pota,unknown,chronic kidney disease stage 3; congestive heart failure; diabetes; hypertension; hyperlipidemia; morbid obesity; bilateral paresis of lower extremity; peripheral edema; sleep apnea; stented artery; history of malignant neoplasm of prostate,,nkda,"['Cardiac death', 'Death', 'Myocardial infarction']",2,MODERNA,IM 1068588,PA,33.0,F,"pregnant; 1st dose 19 Jan 2021, received 2nd dose on 12 Feb 2021; A spontaneous report was received from a 33-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) 24 days apart and is pregnant. The patient's medical history included two previous pregnancies. No relevant concomitant medications were reported. The patient received her first of two planned doses of mRNA-1273 (Batch number: 026L20A) on 19 Jan 2021. On 12 Feb 2021, the patient received her second of two planned doses of mRNA-1273 (Batch number: 013M20) intramuscularly for prophylaxis of COVID-19 infection. On 12 Feb 2021, when the patient received her second dose of the Moderna vaccine, the patient was 5 weeks pregnant. The patient's last menstrual period was 10 Jan 2021. The estimated date of conception was not provided. The estimated due date is 17 Oct 2021. The patient received the first and second dose 24 days apart. No treatment information was provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events, pregnancy and inappropriate schedule of vaccine administration, were considered resolved on 12 Feb 2021.; Reporter's Comments: This is a case of product exposure during pregnancy and inappropriate schedule of vaccine administration (Lot # 026L20A and 013M20) with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,02/12/2021,24.0,UNK,,Pregnancy (3rd pregnancy),,,,"['Inappropriate schedule of product administration', 'Pregnancy']",1,MODERNA,OT 1068589,WI,17.0,F,"17 year old received the first injection of the Moderna vaccine; A spontaneous report was received from a consumer concerning a 17-year-old, female patient who received Moderna's COVID-19 (m-RNA-1273) vaccine. The patient medical history was not provided. No relevant concomitant medication was provided. The patient received their first of two planned doses of mRNA-1273 (batch number not provide) on 13JAN2021 intramuscularly for prophylaxis of COVID-19 infection. On 13-Jan-2021, the patient experienced product administered to patient of inappropriate age. She went back to receive the 2nd dose and was sent home due to being under 18 yo. Treatment taken was not reported. Action taken was not reported. The outcome of event was recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No adverse event history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1068590,RI,,F,"Localized burning; White patch near injection site; Not administered in deltoid, was not at a 90 degree angle; A spontaneous report ), was received from a consumer concerning 55 year old female patient who was administered Moderna's COVID-19 vaccine had experienced burning immediately after injection (PT: vaccination site pain), a white patch near the injection site (PT: vaccine site discoloration), and Incorrect route of product administration. (PT: Incorrect route of product administration) The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 06 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (Batch number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 06 Feb 2021, the patient experienced localized burning immediately following vaccine administration. The burning subsided after 10 minutes. Once the burning subsided, the patient noted a white patch near the vaccination site that was present for 24 hours. . Action taken with mRNA-1273 in response to the event(s) was not provided. The events, localized burning resolved on 06 Feb 2021. The event, white patch near injection site, resolved on 07 Feb 2021.; Reporter's Comments: This report refers to vaccination site pain, vaccination site discoloration and incorrect route of product administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded..",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/06/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Incorrect route of product administration', 'Vaccination site discolouration', 'Vaccination site pain']",1,MODERNA,OT 1068591,IL,,M,"Received the vaccine at 17 years of age; A spontaneous report was received from a consumer, concerning a 17 year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced receiving the vaccine at 17 years of age. The patient's medical history included no relevant adverse event. No relevant concomitant medications were reported. On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 29 Jan 2021, the patient received Moderna COVID-19 Vaccine and he was 17-year-old. Action taken with the second dose of mRNA-1273 in response to the events was not reported. The outcome of the event was resolved on 29 Jan 2021.; Reporter's Comments: This case concerns a 17-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1068592,NV,,M,"Some of the vaccine leaked out as she administered a customer's 1st dose; A spontaneous report was received from a pharmacist concerning a male patient who had some of the vaccine leaked out as she administered a customer's 1st dose (accidental under dose). Patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, prior to onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot/batch: unknown) for prophylaxis of COVID-19 infection. Some of the vaccine leaked out as she administered a customer1s first dose (accidental under dose). No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event Some of the vaccine leaked out as she administered a customer1s first dose (accidental under dose) was considered resolved.; Reporter's Comments: This case concerns a male patient of unknow age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting accidental under dose without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Accidental underdose'],1,MODERNA,OT 1068615,VA,60.0,F,stroke occurred five days after receiving vaccine. I was hospitalized overnight in General Hospital. Have had two MRI's.,Not Reported,,Yes,Yes,1.0,Not Reported,N,01/19/2021,01/24/2021,5.0,MIL,Protonix 40 MGvggcxx xgf Levothyroxine 50 MCG Venlafaxine HCI 37.5 MG Herceptin 440 MG Vitamin D3 50 MCG Vitamin C Magnesium Citrate 250 MG,,breast cancer in remission since 2003. Still get Herceptin shot every 4 weeks,,sulfa,"['Cerebrovascular accident', 'Computerised tomogram', 'Magnetic resonance imaging']",1,PFIZER\BIONTECH,SYR 1068619,VA,29.0,F,Approximately thirteen hours after I received my second dose of the vaccine I started having cramping in my abdomen. The cramping got increasingly worse and I started to get really bad chills. The cramping feeling turned into a stabbing pain and reached a threshold that I could no longer stand so my husband had to drive me to the ER. I have never been in so much pain. Once it the ER I received medicine for the pain and a CT scan that revealed that I had appendicitis and needed to have it removed with an appendectomy.,Not Reported,,Yes,Yes,2.0,Not Reported,N,02/26/2021,02/26/2021,0.0,SCH,None.,None.,Was born with a hole in my heart but it has been closely monitored and they have even reported that they think it may have closed and I no longer have a murmur.,,None.,"['Abdominal pain', 'Appendicectomy', 'Appendicitis', 'Chills', 'Computerised tomogram abdomen abnormal']",2,PFIZER\BIONTECH,SYR 1068635,WV,72.0,M,"Two days after patient received second dose of Moderna COVID-19 vaccine, he presented to the emergency department with complaints of abdominal pain radiating to his back. He denies alcohol use or fatty meals recently, does not smoke, denies nausea/vomiting/diarrhea, chest pain, shortness of breath, fevers or chills. In ED he was mildly tachycardic, otherwise hemodynamically stable.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,02/25/2021,02/27/2021,2.0,PVT,lisinopril-hydrochlorothiazide 20-12.5mg po daily tamsulosin 0.8mg po qHS atorvastatin 40mg po daily clopidogrel 75mg po daily aspirin 81mg po daily B complex w/ C 1 tablet po daily bioflavanoid C complex 1000mg po daily grape seed 1 table,,"History of CABG x 1, cholecystectomy, hypertension, ""mini"" stroke of left eye, cataract surgery bilateral in 2013, small bowel obstruction in 2019",,NKDA,"['Abdominal pain', 'Back pain', 'Cellulitis', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram pelvis abnormal', 'Ileus', 'Laboratory test normal', 'Lipase increased', 'Pain', 'Pancreatitis acute', 'Tachycardia', 'White blood cell count increased']",2,MODERNA, 1068640,MN,61.0,M,"2/17 - Headache; Temp of 100.2, 2/20 - Hypoxia, drowsiness, lethargy",Not Reported,,Yes,Yes,5.0,Not Reported,N,02/17/2021,02/17/2021,0.0,SEN,"Augmentin, Lipitor, Clozaril, Dulcolax, Depakote, Proscar, Keppra, Wixela, Prilosec, Metformin, Ditropan, Zoloft, Prednisone, Spiriva","Bladder Cancer, pneumonia, COPD exacerbation","Schizophrenia, brain injury, COPD, GERD, Epilepsy, Type II dm, recurrent pneumonia",,"Nickel, Prolixin","['Body temperature increased', 'Chest X-ray', 'Headache', 'Hypoxia', 'Lethargy', 'Somnolence']",2,MODERNA,IM 1068668,OH,40.0,F,"Person received an injection of covid-19 vaccine. She sat down for 15 minutes. Tingling began in left arm, and person felt slight lightheadedness during observation. As person arose from chair, tingling in left arm began to increase and she asked healthcare worker if the tingling was normal. Worker stated ""I think so"". Friend then aided person as she began to fall to floor - person then placed on stretcher and became unconscious. EMTs times two were summoned to stretcher and they placed heart monitor and blood pressure cuff on person. Person was transferred to the Health Center - upon transfer, person became conscious and felt a heaviness on left side of body. Able to ambulate to BR and felt heaviness of left side of body. Bloodwork and CT scan were performed at FCHC and person reported as normal. It was decided by ER Doctor to transfer person to Hosp. Blood was drawn every so often and MRI was performed which person stated was all normal. Hosp. staff kept person overnight for observation. At approximately 2000 on 2/27/2021, person states that she felt back to normal with tingling of left arm subsided. Person was released early afternoon on Sunday, February 28th, 2021 after Doctor assessed person.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/27/2021,02/27/2021,0.0,PUB,Premarin Tylenol Aleve,None,None,,None,"['Blood test normal', 'Cardiac monitoring', 'Computerised tomogram normal', 'Discomfort', 'Dizziness', 'Fall', 'Loss of consciousness', 'Magnetic resonance imaging normal', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 1068694,AZ,45.0,M,Severe subacromial bursitis in L shoulder limiting arm movement x three months. Followed 1 week later by R middle finger MCP joint severe stiffness with inability to flex finger. Now after second dose I have torn medial gastrocnemius head. I am avid runner and weightlifter and none of these conditions existed prior to vaccine. I am currently on crutches unable to walk.,Not Reported,,Not Reported,Not Reported,,Yes,N,12/18/2020,12/19/2020,1.0,PVT,None,None,None,,Sulfa,"['Gait disturbance', 'Injected limb mobility decreased', 'Injection site reaction', 'Muscle rupture', 'Walking aid user']",1,PFIZER\BIONTECH,IM 1068696,NM,77.0,M,"2 days after 2nd dose of Pfizer vaccine pt developed stuffy nose, SOB, but no cough, fever, or chills, then developed an itchy rash on Rt foot that spread to arms and legs resulting in a peticheal rash/lesions on dorsum of feet, shins, thigh, mid abdomen, medial arm and back. Dermatology consult felt due to allergic purpura, and vasculitis possible but less likely. Platlet count in the normal range.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/23/2021,03/01/2021,6.0,PVT,,,"Eosinophilia, Diabetes mellitus type II, Seborrheic Keratosis, Hyperlipidemia, HTN",,Dulaglutide causes a rah,"['Dyspnoea', 'Haematocrit normal', 'Haemoglobin normal', 'Henoch-Schonlein purpura', 'Nasal congestion', 'Petechiae', 'Platelet count normal', 'Rash', 'Rash pruritic', 'Skin lesion', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 1068700,PA,77.0,M,Patient passed away 24 hours after receipt of 1st Dose Pfizer vaccine. Provider does not feel death was due to vaccination. but underlying conditions. No immediate side effects noted from vaccination.,Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,N,02/25/2021,02/26/2021,1.0,PVT,,Known pneumothorax w/ chest tube placement after percutaneous lung biopsy;,current smoker; severe emphysema ; enlarging lung nodules w/ avidity; IA Lung CA with right lower lobectomy;,,,['Death'],1,PFIZER\BIONTECH,IM 1068732,OK,42.0,F,"I got extremely tired, congested on 1/11 went to see PCP. I tested for Covid(results positive) and was told to continue taking Humira. I was super exhausted for days with cough.",Not Reported,,Not Reported,Yes,,Not Reported,Y,12/30/2020,01/11/2021,12.0,UNK,Humara,,Ulcerative?,Flu vaccine(soreness Oct. 2020),Desonide,"['COVID-19', 'Cough', 'Fatigue', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1068733,IA,24.0,M,"Numbness, tingling and pain in arm from shoulder to fingers. Stomach pain. On March 1, early a.m., a mental breakdown occurred and was admitted to hospital. Poor to no communication ability, totally confused, doing bizarre things like turning on water and leaving room, stacking furniture, not knowing where he was.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/17/2021,02/18/2021,1.0,SEN,Sertraline 100 mg. Abilify 5 mg Atorvastatin 20 mg Inderal 10 mg 2x Omeprazole 20mg Hydroxyziene 25 mg Invega susp.,none,Depression High Lipids Schizoaffective disorder,,none,"['Abdominal pain upper', 'Abnormal behaviour', 'Blood test', 'Communication disorder', 'Confusional state', 'Hypoaesthesia', 'Mental disorder', 'Pain in extremity', 'Paraesthesia', 'Urine analysis']",2,PFIZER\BIONTECH, 1068738,MN,67.0,F,"Weakness, body aches, right chest wall pain",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/01/2021,03/02/2021,1.0,PVT,,,,,,"['Asthenia', 'Musculoskeletal chest pain', 'Pain']",UNK,MODERNA, 1068750,CA,86.0,M,"Atrial fibrillation; Cold body temperature especially in the feet; fast heart rate; dizziness; A spontaneous report was received from a consumer regarding her husband, an 86-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced fast heart rate/heart rate increased, cold body temperature/coldness, dizziness and atrial fibrillation. The patient's medical history was not included. Concomitant medications were not reported. On 27 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 06 Feb 2021, approximately 10 days after the patient received the vaccine, he experienced a fast heart rate, dizziness, cold body temperature, and atrial fibrillation. (The wife reports that they purchased an EKG machine, and this is what the machine showed them. Unaware if he had this before the vaccine or not.) Treatment information was not provided. Action taken with mRNA-1273 was unknown. The outcome of the events, fast heart rate, cold body temperature, dizziness and atrial fibrillation, was unknown.; Reporter's Comments: Although a temporal association exist, the event occurred 9 days after vaccine administration and very limited information regarding this patient's medical history concomitant medications were event is also confounded by the patient's advanced age. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,02/06/2021,10.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical history not provided),,,"['Atrial fibrillation', 'Dizziness', 'Feeling cold', 'Heart rate increased']",1,MODERNA,OT 1068751,WI,66.0,F,"Pressure between shoulder blades. It went away then started again on carotid then down arm; Sore arm; hot feeling initially; A spontaneous report was received from a consumer, who was a 66-year-old, female patient who received Moderna's COVID-19 vaccine and who experienced a serious adverse event of chest discomfort requiring hospitalization (reported as: ""heart attack like symptoms, pressure between shoulder blades that went away and then started again on her carotid then down her arm"" and in addition non-serious events of sore arm, and hot feeling. The patient's medical history included borderline type 2 diabetes and allergies to adhesive tape, bleach and chlorine. Concomitant product use was not provided. The patient received her first of two planned doses of mRNA-1273 (LOT 012M20A) on 05-Feb-2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection. Initially on 05-Feb-2021, patient experienced a sore arm that was warm to the touch. However, on 15-Feb-2021, she reported having had heart attack-like symptoms. She stated that it started as pressure between shoulder blades that initially went away and then started again on her carotid and travelled down her arm. She thought it was from loading wood. The patient then went to Emergency Room (ER) where she received a nitro pill which alleviated the pain. The EKG, cardiac enzyme tests, nuclear imaging and stress test were all negative according to the patient's report. She reported having been hospitalized for 2 days. Treatment for the event included a nitroglycerin tablet. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, sore arm, hot feeling initially, heart attack like symptoms, pressure between shoulder blades that went away and then started again on her carotid then down her arm, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship for events cannot be excluded.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/05/2021,02/05/2021,0.0,UNK,,Adhesive tape allergy; Allergy to chemicals (allergic to chlorine); Bleaches & cleansers sensitivity (allergic to bleach); Type 2 diabetes mellitus (Borderline),,,,"['Cardiac stress test', 'Chest discomfort', 'Electrocardiogram', 'Myocardial necrosis marker', 'Vaccination site pain', 'Vaccination site warmth']",1,MODERNA,OT 1068752,PA,15.0,F,"Bruised arm; Itchy; Accidental administration of the Moderna COVID-19 Vaccine to a patient who is 15 years old; A spontaneous report ( was received from a pharmacist concerning a 15-year-old, female patient to who accidently received Moderna's COVID-19 vaccine (mRNA-1273) and experienced accidental administration of the Moderna COVID-19 vaccine to a patient who is 15 years old/product administered to patient of inappropriate age, itchy/pruritus and bruised arm/contusion. The patient's medical history was not provided. No concomitant product use was reported. On 25 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L29A) in the right arm intramuscularly for prophylaxis of COVID-19 infection. On 25 Jan 2021, a 15-year-old female patient received an accidental dose of the Moderna COVID-19 vaccine and experienced an itchy arm. On 28 Jan 2021, the reporter noted the patient had a bruised arm. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, accidental administration of the Moderna COVID-19 Vaccine to a patient who is 15 years old/product administered to patient of inappropriate age, was considered resolved on 25 Jan 2021. The outcome of the events, itchy and bruised arm, were considered unknown.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 12L29A, with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Contusion', 'Product administered to patient of inappropriate age', 'Pruritus']",1,MODERNA,OT 1068753,,,M,"Vaccine not administered correctly; A spontaneous report was received from a physician who was also a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and the vaccine was not administered correctly. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient reported that he doesn't think the vaccine was administered correctly. He stated that he had no arm tenderness or pain after receiving the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine not administered correctly, was resolved on 23 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/23/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Incorrect route of product administration'],1,MODERNA,OT 1068754,NC,,U,"while receiving the 2nd dose, syringed leaked some of it; the syringe leaked some of it; A spontaneous report was received from a Pharmacist regarding a patient of unspecified age and gender who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) and while receiving the second dose, the syringe leaked some of it (Incomplete dose administered/syringe leak). The patient's medical history was not provided. Concomitant medications were not provided. On an unspecified date, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 for the prophylaxis of COVID-19 infection. While receiving the vaccine, the syringe leaked and some of it came out. Action taken with mRNA-1273 vaccine was not applicable as the patient received both planned doses. The events were considered resolved.; Reporter's Comments: This report refers to a case of a patient of unspecified age and gender who experienced non-serious unexpected events the syringe leaked some of it (incomplete dose administered/ syringe leak) for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of Incomplete dose administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history provided),,,"['Incorrect dose administered', 'Syringe issue']",2,MODERNA,OT 1068755,PA,,F,"Dose administered from a not fully thawed vial; A spontaneous report was received from a nurse, concerning a 67 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), which resulted in dose administered from a not fully thawed vial (incorrect dose administered). The patient's medical history was not reported. Concomitant medication reported was simvastatin. On 28 Jan 2021, prior to the onset of the event, the patient received female first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly in the left arm for prophylaxis of COVID-19 infection. It was reported that the vials were stored in the refrigerator. After that, one of the vials was punctured and a dose was administered to a patient. Also, syringes were pre-filled with doses of the same vial (vials still contain some doses). The healthcare professional visually observed the vials and noticed that the suspension was not fully thawed to the patient on 28 Jan 2021. No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the event was not reported. The outcome of the even, dose administered from a not fully thawed vial was recovered on 28 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,SIMVASTATIN,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Incorrect dose administered'],1,MODERNA,OT 1068756,WI,65.0,F,"Patient was given an extra 0.5ml dose right after that; A spontaneous report was received from a Healthcare Professional concerning a 65-years-old, female patient who received Moderna COVID-19 vaccine (mRNA-1273) who was administered an invalid dose, some of the content of the dose slipped through the syringe and the patient was given an extra 0.5ml dose. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 Jan 2021, prior to the onset of the event, the patient received their first dose of the two planned doses of mRNA-1273 (Batch Number 042l28), unknown route in the right arm for prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient received an extra dose of the vaccine right after the patient received an invalid dose. It was reported that the patient was administered an invalid dose on her right arm and 15 minutes later some of the content of the dose slipped through the syringe and the patient was given an extra 0.5ml dose. No treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event patient was given an extra 0.5ml dose was considered recovered.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273. There were no reported AEs associated with this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Accidental overdose'],1,MODERNA,OT 1068757,MN,,F,"Received 1st dose of vaccine at 17 yrs old; Low grade temperature; Chills; Sore arm at the injection site; A spontaneous report was received from a nurse concerning her daughter, a 17-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) (product administered to patient of inappropriate age) and experienced chills, sore arm at the injection site (vaccination site pain) and low grade temperature (body temperature decreased). The patient's medical history was not provided. No relevant concomitant medications were reported. On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 29 Dec 2020, the patient received 1st dose of vaccine at the age of 17 years and experienced chills, sore arm at the injection site (injection site pain) and low-grade temperature. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events received 1st dose of vaccine at 17 yrs old was considered resolved on 29 Dec 2020. The outcome of events chills, sore arm at the injection site and low-grade temperature were not reported at the time of this report.; Reporter's Comments: This case concerns a 17-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age and associated adverse events of chills, vaccination site pain, and low body temperature decreased. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Body temperature decreased', 'Chills', 'Product administered to patient of inappropriate age', 'Vaccination site pain']",1,MODERNA, 1068758,TX,54.0,F,"Vaccine doses administered 23 days apart; Dizziness; Headache; Nausea; Body aches; Extreme fatigue; A spontaneous report was received on 08-Feb-2021 from a pharmacist concerning a 54 years aged female patient who received Moderna's COVID-19(mRNA-1273) and developed severe headache,dizziness, nausea, body aches, extreme fatigue, and the vaccine doses administered 23 days apart. The Patient medical history includes several autoimmune disorders. Concomitant medications include tylenol, aleve, enbrel, and muscle relaxants. On 06-Jan-2021, patient received her first dose of mRNA-1273 (Batch:unknown) intramuscularly on her left arm shoulder deltoid muscle for the prophylaxis of covid-19 infection. On 29-Jan-2021, prior to the onset of events patient received her second dose of mRNA-1273(Batch;041L20) intramuscularly on her left arm shoulder deltoid muscle for the prophylaxis of Covid-19 infection. On 29-Jan-2021, patient experienced severe headache, dizziness, nausea, body aches, extreme fatigue that resolved on 08 Feb 2021. No laboratory information was provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable The outcome of the events were recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 (lot # 041L20) with reported associated AEs after the second dose of severe headache, dizziness, nausea, body aches, and extreme fatigue. Based on the current available information and temporal association between the use of the product after the second dose and the start date of the events, a causal relationship cannot be excluded",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/29/2021,23.0,UNK,TYLENOL; ALEVE; ENBREL,,Medical History/Concurrent Conditions: Autoimmune disorder NOS (several autoimmune disorders history),,,"['Dizziness', 'Fatigue', 'Headache', 'Inappropriate schedule of product administration', 'Myalgia', 'Nausea']",2,MODERNA,OT 1068759,NY,,U,"The needle came off the syringe and some of the dose went down the patient's arm; The needle came off the syringe and some of the dose went down the patient's arm; The needle came off the syringe and some of the dose went down the patient's arm; A spontaneous report was received from a pharmacist, concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine and where the needle came off the syringe and some of the dose went down the patient's arm. The patient's medical history was not provided. Concomitant medications use was not provided. On an unspecified date, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis. On an unspecified date, while administrating vaccine the needle came off the syringe and some of the dose went down the patient's arm. The reporter was unsure of the dose that was delivered to the patient. Treatment information was not provided Action taken with mRNA-1273 in response to the events were not reported. The outcome of the event, the needle came off the syringe and some of the dose went down the patient's arm was considered resolved on an unspecified date.; Reporter's Comments: This report refers to a case of incorrect dose administered, exposure via skin contact and syringe issue for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Exposure via skin contact', 'Incorrect dose administered', 'Syringe issue']",1,MODERNA, 1068780,IL,22.0,F,"Patient received Moderna vaccine on 2/23/21 and presented to hospital on 03/02/21 with symptoms of covid-19 infection. Tested positive at birth center on 03/01/21 and began feeling symptomatic on 02/28-03/01. Patient is symptomatic and has had maternal tachycardia, fever, fatigue, myalgias, cough, shortness of breath. Of note, there is associated fetal tachycardia. Patient is preterm and today is a 22 y/o G2P0010 at 34+4. Has thus far received adequate prenatal care with no pregnancy complications.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/23/2021,03/01/2021,6.0,PVT,tylenol,,,,,"['COVID-19', 'Cough', 'Dyspnoea', 'Exposure during pregnancy', 'Fatigue', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test positive', 'Tachycardia', 'Tachycardia foetal']",1,MODERNA,IM 1068791,TN,70.0,F,"High fever, extreme malaise, severe vertigo ( 5 days and counting)",Not Reported,,Not Reported,Not Reported,,Yes,N,02/25/2021,02/25/2021,0.0,SEN,"Aspirin, acetaminophen ; metformin; amyrl",None,DM,,None,"['Full blood count', 'Laboratory test', 'Malaise', 'Pyrexia', 'Urine analysis', 'Vertigo']",2,MODERNA,SYR 1068803,IL,80.0,F,"38 hours after vaccine was given, patient awoke to a heart attack...says it felt like someone punched her between the shoulder blades and kept their fist there, pain then radiated down both arms to the elbows - more substantial on the rt side, pain also radiated up to the back of her jaw.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,02/15/2021,02/17/2021,2.0,PVT,"Before the heart attack: Morning meds taken at 8am: 220 mg Aleve, 81mg Aspirin EC, Brio Ellipta inhale, 20 mg Omeprazole, Fiber Con, lisinopril, 20 mg simvastatin Evening meds taken at 8pm: 220 mg Aleve, 25 mg Benadryl, 3 mg Melatonin, 20",,"COPD, pre-diabetic, PAB done in 2017, HTN, high B/P",,"Contrast iodine, Isovue, Cefadroxil, Plavix","['Arthralgia', 'Coronary arterial stent insertion', 'Myocardial infarction', 'Pain', 'Pain in extremity', 'Pain in jaw']",1,PFIZER\BIONTECH,IM 1068813,,88.0,F,"During observation after patient received 2nd dose Pfizer vaccine, patient complained about chest pain, BP 173/81. Patient described chest pain before receiving vaccination when being evaluated in observation. Taken to ED and admitted to hospital. Noted to have ischemia on stress test with multivessel disease. Patient discharged from hospital.",Not Reported,,Not Reported,Yes,5.0,Not Reported,,02/26/2021,02/26/2021,0.0,PVT,,,,,,"['Cardiac stress test abnormal', 'Chest pain', 'Coronary artery disease', 'Ischaemia']",2,PFIZER\BIONTECH,IM 1068814,MO,66.0,M,"9 days after vaccination, the patient was found deceased in his home, sitting on his couch. Determined to be due to pulmonary embolism.",Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/25/2021,9.0,PHM,Allopurinol; gemfibrosil; indomethacin; lisinopril,none,Gout,,no,"['Death', 'Pulmonary embolism']",UNK,MODERNA, 1068818,NJ,44.0,F,"Within minutes, Xavier felt burning sensation but did not report it while she was in the observation room because she thought it will go away just like it did with first dose. She then started to have rashes, low grade fever, and felt weak same day, and went on the following day. On 2/21/21 she had generalized swelling and rashes, difficulty breathing and went to the hospital.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,SEN,Singulair inhaler,None,Asthma,,PCN,"['Asthenia', 'Burning sensation', 'Dyspnoea', 'Pyrexia', 'Rash', 'Swelling']",2,PFIZER\BIONTECH,IM 1068850,TX,70.0,F,"Pfizer-BioNTech COVID- 19 Vaccine EUA: Wife of patient called Primary Care Physician to inform that patient had received dose #2 of Pfizer COVID vaccine, and later that evening experienced a seizure and expired.",Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,U,02/26/2021,02/26/2021,0.0,PVT,"Calcitriol 0.25 mg daily, Carvedilol 25 mg BID, (Cont.) Ergocalciferol 50,000 units weekly, Epoetin alfa, Furosemide, Hydrocodone/acetaminophen 10/325 mg Q6H PRN, Mycophenolate sodium 360 mg BID, Prednisone 10 mg daily, Sevelamer carbonate",,"Cardiomegaly, Hypertension, BK virus nephropathy, Acute Kidney Inj., Chronic pain, Kidney Transplant, (cont.) Anemia of chronic disease, Immunosuppression, Arthritis, Depression, Spinal stenosis, cytomegalovirus infection, degenerative joint disease.",,Vancomycin (itching),"['Death', 'Seizure']",2,PFIZER\BIONTECH,IM 1068856,CA,73.0,M,"Patient presented to ED with progressively worsening angioedema presumably due to either h/o heraditory angioedema, lymphoma, or in combination with recent Covid vaccine. Patient had swelling to the lips, throat, and neck. Patient had similar symptoms in the past that resolved spontaneously within a day or received ecallantide on a different occasion in 2015. Suspected angioneurotic edema per hematology and was treated with epi, Benadryl, Pepcid, Solu-medrol, and Kalbitor for HAE. No edema visualized, clear voice, and no issues with swallowing on the next day.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/04/2021,02/14/2021,10.0,PHM,tadalafil,,History of Idiopathic angioedema and Prostate cancer,,None,"['Angioedema', 'Chest X-ray normal', 'Condition aggravated', 'Eosinophil percentage', 'Lip swelling', 'Pharyngeal swelling', 'Swelling']",1,PFIZER\BIONTECH,IM 1068889,,85.0,M,"death Narrative: no other details available, as nothing documented in record",Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/25/2021,27.0,OTH,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1068890,,77.0,M,"death Narrative: unclear of details, s/p spine surgery on 2/2/21 and discharged on 2/6/21",Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,N,01/13/2021,02/11/2021,29.0,OTH,,,,,,"['Death', 'Spinal operation']",1,MODERNA,IM 1068897,MD,66.0,M,"Presented to the ED on 3/1/21 with progressively worsening SOB with cough for past 1.5 weeks. He also reported having bright red blood per rectum for the past 6 months. He denied fever, N/V, abdominal pain, etc. He reports that he stopped smoking ~2 weeks ago and this is when his symptoms started. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,,Not Reported,,02/09/2021,03/01/2021,20.0,PVT,,,"Atrial fibrillation, COPD, CKD, hx of cancer",,,"['Cough', 'Dyspnoea', 'Ex-tobacco user', 'Rectal haemorrhage']",2,MODERNA,IM 1068901,NH,67.0,F,"ER admit for CP and Jaw pain, exhaustion, Aortic arteritis normal SED rate found on CT scan hospital admit IV medications required Solumedrol and Actemra questionable how much medications received d/t IV's not working. Released from care on 2/19 with prednisone . Symptoms still present off and on. 2/21 922pm CP Jaw Pain severe EMT's called EKG done reported no heart attack, pain better, EMTs left. 10/15 severe Pain collapsed with no pulse and no breathing, EMTs returned unable to obtain a shock-able rhythm time of death pronounced. reason for death on certificate Aortitis - hospitalist thinks aortic dissection d/t severe inflammation",Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/21/2021,22.0,PVT,Prednisone BP medication,"COVID prior to vaccination - still having symptoms SOB, Tired, foggy head -thinking",GCA Arthritis,,,"['Aortic dissection', 'Aortitis', 'Arteritis coronary', 'Cardioversion', 'Chest pain', 'Computerised tomogram', 'Computerised tomogram normal', 'Death', 'Echocardiogram', 'Electrocardiogram', 'Electrocardiogram normal', 'Fatigue', 'Inflammation', 'Laboratory test', 'Pain in jaw', 'Pulse absent', 'Red blood cell sedimentation rate normal', 'Respiratory arrest', 'Syncope']",UNK,MODERNA,IM 1068911,PA,36.0,F,"Patient experienced redness, hotness, itchy, SOB, tightness of chest, swollen lips, redness to face/neck. Administered epinephrine 0.3 mg IM and diphenhydramine 50 mg IV x 1. Monitored on sight for 45 minutes and transferred by EMS to emergency department. In ED administered methylprednisiolone 125 mg IV x1 and pepcid 20 mg IV once. Patient was discharged from the ED; however, developed facial pruritus, chest tightness and dyspnea and returned to ED. Admitted to obs unit on /5 at 0845 and discharged the next day on 2/6 at 1018.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/04/2021,02/04/2021,0.0,WRK,unknown,unknown,unknown,,Chlorhexidine Hibiclens Amoxicillin Methylphenidate Sulfa Omalizumab Dust Mite Compazine Peach Shellfish polysorbate added after COVID 19 vaccine administered.,"['Chest discomfort', 'Dyspnoea', 'Erythema', 'Feeling hot', 'Lip swelling', 'Pruritus']",1,MODERNA,IM 1068925,FL,78.0,F,Triggered arthritic flareup. . It caused inflamed right hip enough to jam the nerves in the right leg. Taking 2 anti-inflamatory drugs and treating for pain.,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/12/2021,02/13/2021,1.0,OTH,"Benicar, Welchol, Estradiol, Medroxypril, Hctz, Alondrondate, Flonaise, Ultimate Flora, Florassist Mood, Vision formula, Aspirin",No,HIgh blood pressure; high cholesterol,,"Prinivil; Codene, Norvasc, Niacin, Sulphur","['Arthralgia', 'Arthritis', 'Inflammation', 'Neuropathy peripheral', 'Pain in extremity']",UNK,MODERNA, 1068931,MA,93.0,M,"Case passed away on 2/28/21. During post vaccination monitoring, case did not have any adverse reactions. When writer spoke to him on 2/26/21 to schedule his second dose, he sounded well.",Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/28/2021,11.0,PUB,Bymetanide (1MG tablet) 1x daily Lisinopril (10MG tablet) 1x daily Terazosin (10MG tablet) 1x daily,"No other illnesses. He spent six days at a nearby hospital last week. Came home Thursday, February 25, 2021, as his blood work indicated that he had stopped bleeding and was stable. Per family, ""he was in good spirits Friday and Saturday which started to change Sunday morning."" He passed way in his sleep sometime late Sunday night or very early Monday morning. I believe his date of death will be 3/1/2021.",Diverticulitis Spinal Stenosis,,None,"['Blood test', 'Death', 'Haemorrhage']",1,MODERNA,IM 1068940,FL,42.0,F,"SOB, numbness, tingling, swelling in lips and mouth.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/02/2021,02/02/2021,0.0,PVT,,,prior history of idiopathic angioedema,,,"['Dyspnoea', 'Hypoaesthesia oral', 'Lip swelling', 'Mouth swelling', 'Paraesthesia oral']",1,MODERNA,IM 1068963,WA,85.0,F,approximately 24 hours post vaccine Patient developed a low grade fever of 99.5 and had increased fatigue. 48 hours later she had decreased neurological functioning. 02/23 she had difficulty swallowing. 02/23 She was admitted to hospice services. 02/26 she passed just before 10 am.,Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/18/2021,1.0,SEN,"Cranberry Tablet, Ferrous Sulfate, Levothyroxine, Metoprolol, Mirtazapine, Omeprazole, Risperidone, Vitamin C, Vitamin D3, Asprin, Alprazolam, Vitamin B Complex, B 12 injections","Adenocarcinoma of colon, hypothyroidism, Alzheimer's dementia with behaviors disturbance, Anxiety, A Fib, GERD, recurrent UTI, Vitamin B 12 deficiency.",See Item 11,,NKDA,"['Conversion disorder', 'Death', 'Dysphagia', 'Fatigue', 'Pyrexia']",2,MODERNA,IM 1068964,NY,77.0,F,"Vaccinated with Pfizer COVID vaccine on 1/21/21 and 2/12/21. Unknown facility, lot number Hospital course 2/24 ? 2/26/21 2/24 Chief complaint: Chest Pain. Per EMS - CP and SOB started 1220. Mid CP radiating to left arm. semi-relief with nitro x 2. Reports N. Denies V and no other symptoms. Hx cardiac stents, MI. HPI: Patient is a 77-year-old female who presents to the ER for evaluation of chest pain. Patient states that her chest pain started this afternoon around 1230 when she was cooking lunch. She says it lasted for about 10 minutes and was a intense substernal chest pressure sensation with radiation down her left arm. She had associated shortness of breath and diaphoresis and also endorsed nausea without vomiting. Patient also states she is had some occasional dizziness which she described as a room spinning sensation is made worse when she is in positions and standing or moves her head. She has a history of 2 heart attacks and 2 stents placed which were done. She has no local cardiology follow-up and she lives at an apartment and follows with pace. EMS gave her 4 aspirin prior to arrival she takes no blood thinners but she does take Plavix. Patient has a history of COPD and also endorses some wheezing, she says they took her nebulizer away from her for fear of spreading coronavirus and she is oxygen dependent at nighttime. COVID positive 2/24/21 (this assay amplifies and detects The target rna using real-time pcr. Testing performed on cepheid genexpert) Patient states she tested negative for COVID 19 last week at her PCP and got her 2nd COVID 19 vaccine on 2/11/2021. She reports having dinner with a friend 3 weeks ago who just passed away from COVID 19. EKG shows normal sinus rhythm with incomplete right bundle branch block and no obvious ST segment elevations or acute ischemic intervals Troponin negative Patient admitted to the COVID unit. Home (baseline) O2 requirement 2.5L at night 2/25: 3L O2 nasal cannula continuously, reduced to 2L within 12 hours No fever COPD with acute exacerbation: Diffusely wheezing bilaterally and in tripod position on exam. Start IV Solu-Medrol COVID-19 viral infection: Start IV Remdesivir as she is now requiring supplemental oxygen. IV steroids as above. Chest pain, history of CAD with previous stenting --Denies any chest pain on exam. EKG negative for ischemic changes. Troponin negative x1. Continue to trend troponin x2 more occurrences. --Continue Aspirin, Plavix, statin, Imdur. Anxiety disorder: Continue Prozac. Add Xanax 0.25 mg 3 times daily as needed. 2/26: medically ready for discharge to SNF COVID unit. Augmentin 875/125 x 7 days dexamethasone 6mg daily x 8 days",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/21/2021,02/26/2021,36.0,UNK,Prior to admission albuterol (PROVENTIL HFA;VENTOLIN HFA) 108 (90 BASE) MCG/ACT inhaler budesonide (PULMICORT) 0.5 MG/2ML nebulizer solution CALCIUM CITRATE-VITAMIN D PO Carboxymethylcellulose Sodium (THERATEARS) 0.25 % SOLN cetirizine (ZY,,"Past medical history Anxiety and depression CAD S/P percutaneous coronary angioplasty COPD (chronic obstructive pulmonary disease) DM2 (diabetes mellitus, type 2) HTN (hypertension) Osteoarthritis Osteoporosis Restless leg syndrome Past Surgical History Appendectomy Coronary angioplasty with stent placement Hysterectomy Rotator cuff repair left Tonsillectomy",,Meperidine ? hives Sulfonamide antibiotics - hives,"['COVID-19', 'Chest X-ray normal', 'Chest discomfort', 'Chest pain', 'Chronic obstructive pulmonary disease', 'Differential white blood cell count normal', 'Dizziness', 'Dyspnoea', 'Echocardiogram', 'Electrocardiogram normal', 'Exposure to SARS-CoV-2', 'Fibrin D dimer normal', 'Hyperhidrosis', 'Influenza A virus test negative', 'Influenza B virus test', 'Lipids increased', 'Nausea', 'Neutrophil count increased', 'Neutrophil percentage increased', 'Pain', 'Pain in extremity', 'Respiratory syncytial virus test negative', 'SARS-CoV-2 test positive', 'Serum ferritin normal', 'Troponin I normal', 'Vomiting', 'Wheezing', 'White blood cell count normal']",1,PFIZER\BIONTECH,UN 1068968,MD,84.0,M,"Patient presented to the ED reporting that he was feeling ""real weak"". In the ED, he was found to be hypoxic, tachycardic, and hypothermic with a temperature of 93.2. Pt has history of COPD (on chronic oxygen), HTN, CAD, atrial fibrillation, spinal stenosis, bilateral pleural effusions requiring thoracentesis. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/09/2021,02/27/2021,18.0,PVT,,,,,,"['Asthenia', 'Body temperature decreased', 'Hypothermia', 'Hypoxia', 'Tachycardia']",1,PFIZER\BIONTECH,IM 1068991,MD,66.0,M,Patient presented to ED after he became dizzy while shooting pool and felt his defibrillator fire. Patient underwent diagnostic cardiac cath and it was deemed that there would be no intervention at this point. Patient was discharged with plans to follow up with PCP and cardiologist,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/05/2021,02/28/2021,23.0,PVT,,,"Cardiomyopathy, atrial fibrillation (has ACID)",,,"['Cardiac assistance device user', 'Catheterisation cardiac', 'Dizziness']",1,MODERNA,IM 1068993,WA,48.0,F,Spontaneous intracerebral hemorrhage and death on 2/20/2021,Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,N,01/23/2021,02/20/2021,28.0,OTH,Unknown,Unknown,"Hypertension, morbid obesity",,Unknown,"['Autopsy', 'Cerebral haemorrhage', 'Death']",2,MODERNA,IM 1069009,PR,94.0,M,Several days after vaccination his left arm turned red. He was taken to the hospital where he was evaluated and admitted with a diagnosis of left axillary vein thrombosis. A chest X-ray was taken and he presented bibasilar atelectasis and pneumonia with pleural effusions.,Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/30/2021,9.0,SEN,None,Swollen hands,None,,None,"['Atelectasis', 'Axillary vein thrombosis', 'Chest X-ray abnormal', 'Erythema', 'Pleural effusion', 'Pneumonia']",1,MODERNA,IM 1069019,AZ,30.0,M,"BELL'S PALSY, FACIAL PARALYSIS",Not Reported,,Not Reported,Not Reported,,Yes,N,02/05/2021,02/25/2021,20.0,PVT,AMLODIPINE 5MG,,HYPERTENSION,,,"[""Bell's palsy"", 'Facial paralysis', 'Neurological examination']",1,PFIZER\BIONTECH,IM 1069021,MD,72.0,F,"Patient presented to ED after her GI specialist referred her for an abnormal hgb level. Patient reported fatigue for past several days but denied any abdominal symptoms or symptoms of bleeding. In the ED, patient's hgb was found to be 5.2. Pt received blood transfusion and was treated with protonix. She underwent an endoscopy and a colonoscopy. Pt was discharged to follow up with GI and PCP",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,02/19/2021,02/26/2021,7.0,PVT,,,"History of GI bleed, HTN, hypothyroid, afib, CAD, CKD",,,"['Colonoscopy', 'Endoscopy', 'Fatigue', 'Haemoglobin abnormal', 'Haemoglobin decreased', 'Transfusion']",2,MODERNA,IM 1069026,,74.0,M,Death Narrative: Family was able to be present at bedside shortly after patient was extubated. Fentanyl bolus given 10-15 minutes prior. Patient passed away soon after endotracheal tube removed. Time of death 10:14am.,Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/26/2021,21.0,OTH,,,,,,"['COVID-19', 'Death', 'Endotracheal intubation', 'Mechanical ventilation']",2,MODERNA,IM 1069048,,,F,"Disk injury; shingles on my left leg; pulled leg; Back pain; A spontaneous report was received from a consumer who was also a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pulled the leg, back pain from disk injury, and shingles on left leg. The patient's medical history was not provided. Concomitant product use was not provided. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. The patient reported she was hospitalized with pulled leg and back pain from disk injury and shingles on left leg. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not provided. The outcome of the events were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Back pain', 'Herpes zoster', 'Muscle strain', 'Spinal cord injury']",1,MODERNA,OT 1069049,NY,65.0,M,"Covid-19; A spontaneous report was received from a 65-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID-19. The patient's medical history was not provided. No relevant concomitant medications were reported. On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient reported he was admitted to the hospital a week ago because he was positive for COVID-19. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, COVID-19 was not provided.; Reporter's Comments: This case concerns a 65-year-old male who was hospitalized with a serious unexpected event of COVID-19. The event occurred with unknown latency after the first dose of mRNA-1273. Treatment was not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/19/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['COVID-19'],1,MODERNA,OT 1069050,OH,,F,"passed out; almost delirious; couldn't lift leg; pain went all the way down left side of body; sweating; chills; felt heavy weight on chest; left leg hurting so bad like a charley horse; weak all over; allergic reaction; pain in left arm at injection site; felt extremely tired; A spontaneous report was received from a consumer, via notification from another manufacturer, concerning a 79 year-old female patient who experienced an allergic reaction (hypersensitivity); passed out (loss of consciousness); almost delirious (delirium); couldn't lift leg (femoral nerve injury); pain radiating down leg (pain); sweating (hyperhidrosis); chills; heavy weight on chest (chest discomfort); leg hurting like Charlie horse (muscle spasms); weak all over (asthenia); pain in left arm where she got the shot (injection site pain); felt extremely tired (fatigue). The patient's medical history included sinus issues and drug allergies to glycopyrrolate, sulfa, meloxicam, erythromycin and azithromycin. The patient stated that she had a long list of names and ingredients of things she is allergic to. Products known to have been used by the patient, within two weeks prior to the event, included Amiodipine. On 28 Jan 2021, approximately 12 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 028120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient reported that she received the vaccine dose around 12:00 or 12:30 pm. The patient reported that she woke up with extreme pain in the left side and in the left arm where she got the shot. The pain went all the way down her body and she reported it as severe pain. She reported that the pain would not go away. The patient reported that she started sweating, had chills, and she felt heavy like a weight on her chest, but she was breathing okay. Her leg on the left side started hurting so bad that it was like a big Charley horse that would not go away. She got out of the bed and tried to see if she could stand on it, but she could not. She tried to rub it, but it did not help. She tried to walk on it, but by that time she was almost delirious. She was sweating so bad and she was weak all over. She had become extremely tired and she ended up laying on the floor because she could not get her leg to lift in order to get back in the bed so she just laid on the floor. By that point, she did not know if she had passed out or fallen asleep, but she does not think she fell asleep because it was too much pain to sleep. When she woke up and came to, the pain in her leg was gone. However, she was still sweating. She could not get back in the bed. The following morning, she was extremely weak and tired. She still felt heavy on her chest like something had been pushed on her. She was hurting, weak, and tired, but the pain was not extreme like it had been that night. She clarified the time of onset for this event was around midnight, but she could not look at the clock to confirm the exact time. She reported the event either started the night of 28 Jan 2021 or early in the morning hours of 29 Jan 2021. She called her doctor, Moderna, and the pharmacist to ask about the ingredients of the vaccine. Treatment information was unknown. Action taken with mRNA-1273 in response to the events was withdrawn. The events, passed out and pain in left leg, was considered resolved the following day. The events of sweating, weakness, tiredness, and heavy chest was improved the following day. The outcome of the events, allergic reaction, delirious, pain in left arm, pain in left side of body, chills, couldn't lift leg, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/01/2021,,UNK,AMLODIPINE,Allergy to antibiotic (erythromycin); Allergy to antibiotic (azithromycin); Blood pressure high; Drug allergy (allergic reaction to Mobic caused extreme reaction requiring hospitalization); Drug allergy (allergic reaction to anesthesia Robinul while undergoing D&C; caused cardiac arrest.); Sulfonamide allergy,Medical History/Concurrent Conditions: Sinus pain (Sinus acting up every now and then),,,"['Asthenia', 'Chest discomfort', 'Chills', 'Delirium', 'Fatigue', 'Femoral nerve injury', 'Hyperhidrosis', 'Hypersensitivity', 'Injection site pain', 'Loss of consciousness', 'Muscle spasms', 'Pain']",1,MODERNA,OT 1069051,PA,82.0,F,"So tired; No energy, very weak; Same night went into afib; A spontaneous report was received from a 82 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced atrial fibrillation, so tired and no energy, very weak. Patient's medical history included atrial fibrillation. Relevant concomitant medications included prednisone and benadryl. On 28 JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On the same day, patient experienced atrial fibrillation. On 29 JAN 2021, she was so tired and had no energy and was very weak which lasted for 6 days. She thought that this was due to prednisone and Benadryl prophylactically. On the same day, her sinus rhythm was found to be back to normal. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The events atrial fibrillation was considered resolved on 29 JAN 2021 and the events so tired and no energy, very weak were considered resolved on 04 FEB 2021.; Reporter's Comments: This case concerns an 82 year old female patient, with medical history of paroxysmal atrial fibrillation (2016), who experienced a serious unexpected event of atrial fibrillation, among other non-serious events, after receiving first dose mRNA- 1273 (Lot# unknown). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,BABY ASPIRIN,,Medical History/Concurrent Conditions: Paroxysmal atrial fibrillation,,,"['Asthenia', 'Atrial fibrillation', 'Fatigue', 'Sinus rhythm']",UNK,UNKNOWN MANUFACTURER, 1069052,FL,90.0,F,"sepsis; UTI; shingles; severe headaches; A spontaneous report was received from a 90-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced UTI, sepsis, shingles, and headaches. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient began experiencing severe headaches. On 11 Feb 2021, the patient developed a severe urinary tract infection and had to be hospitalized. The patient broke out with shingles and now has sepsis. The patient is reported as being conscious, but not responding. No treatment information was provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcomes of the events, UTI, sepsis, shingles, and headaches, were not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/04/2021,02/05/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Headache', 'Herpes zoster', 'Sepsis', 'Urinary tract infection']",2,MODERNA,OT 1069053,NJ,,F,"Pain in the chest; High Blood Pressure; Acid Reflux; Weak On and Off; A spontaneous report was received from a consumer concerning a 78-year-old, female patient who received a second dose of Moderna's COVID-19 vaccine experienced chest pain, high blood pressure, acid reflux, weak on and off. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly on an unknown date in Jan-2021. On 11-Feb-2021, patient received their second of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 12-Feb-2021, in the morning patient had chest pain which lasted all day. She went to emergency room. Procedures performed at emergency room were blood pressure measurement which was high, electrocardiogram and chest X-ray with normal results. Patient stayed overnight at the hospital for observation. The next morning on 13-Feb-2021, nuclear scan of heart was performed, and it came out normal. Patient got discharged on same day. Sunday morning on 14-Feb-2021 she was weak but in the afternoon she felt better. The weakness has been on and off. Monday morning on 15-Feb-2021 weak again and in the afternoon, she was fine again. Patient was concerned if her symptoms were normal after second dose of vaccine. Acid reflux medication was provided at the hospital. Consent for safety Follow up given. The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events, experienced chest pain, high blood pressure, acid reflux, weak on and off were considered unknown.; Reporter's Comments: Based on the information provide which includes a temporal association, a causal association between the reported events and the administration of the mRNA-1273 cannot be excluded",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/01/2021,02/12/2021,42.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Asthenia', 'Blood pressure measurement', 'Chest X-ray', 'Chest pain', 'Electrocardiogram', 'Gastrooesophageal reflux disease', 'Hypertension', 'Magnetic resonance imaging heart']",2,MODERNA,OT 1069054,NY,66.0,F,"Anxious; Tired; Blood clots in left leg, right leg and brain; A spontaneous report was received from a consumer who was also a 66-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed blood clots in the left leg, right leg, and brain, anxious and tired. The patient's medical history was not provided. Concomitant medications reported included vitamin D, magnesium, lisinopril, and vitamin B12. On 14 Jan 2021, approximately 3 days prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 16 Jan 2021, the patient experienced immense pain in the middle of the night, and subsequently saw her primary physician. An ultrasound revealed blood clots in her left leg, right leg and brain. A hematologist and vascular surgeon were consulted. Patient was treated with apixaban while they are doing blood work. The patient also became tired and anxious. She noted that she never had comorbidities before and was upset that her life has completely changed. A repeat ultrasound was scheduled for 19 Feb 2021. The mRNA-1273 dose was discontinued in response to the event of blood clots in the left leg, right leg, and brain, anxious and tiered. The outcome of events, blood clots in the left leg, right leg, and brain was considered unknown at the time of this report. The outcome of the events, tired and anxious were considered not resolved at the time of this report.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/16/2021,2.0,UNK,VITAMIN D NOS; MAGNESIUM; LISINOPRIL; VITAMIN B12 NOS,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Anxiety', 'Fatigue', 'Thrombosis', 'Ultrasound scan']",1,MODERNA,OT 1069055,CO,,F,"patient received less than one half of the recommended dose; vaccination liquid began to leak out of the sides of the syringe; vaccine liquid dripped down patients arm; A spontaneous report was received from a Healthcare professional concerning a 71 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced under dose, device connection issue and exposure via skin. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) and on 17 Feb 2021, the patient received the second dose of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient experienced under dose, device connection issue and exposure via skin. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. At the time of this report, the outcome of the events, less than half of dose administered, vaccine liquid leaked out sides of syringe and dripped down the patient's arm were recovered.; Reporter's Comments: This report refers to a case of Product administration error � under dose, device connection issue and exposure via skin contact for mRNA-1273, lot # unknown with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,"['Device connection issue', 'Exposure via skin contact', 'Underdose']",2,MODERNA,OT 1069056,NC,90.0,F,"Hallucinating; Urinary tract infection; A spontaneous report was received on 22 Feb 2021 from a consumer concerning a 90-year-old female patient who received Moderna's COVID-19 vaccine and developed a medically important event of hallucinations, and in addition urinary tract infection. The patient medical history was not provided. Relevant concomitant medications provided included acetylsalicylic acid, vitamin d3, unspecified vitamin b12 , donepezil hydrochloride, levothyroxine, melatonin, omeprazole, permethrin and hydrocortisone. The patient received their first of two planned doses of Moderna's mRNA-1273(BATCH/LOT # 032L20A) on 22 Jan 2021 for the prophylaxis of COVID-19 infection. On 12 Feb 2021, patient received their second of two planned doses of Moderna's mRNA-1273(BATCH/LOT # 013M20A) in the left arm for the prophylaxis of COVID-19 infection. On 20 Feb 2021, in 9 days of receiving vaccine, patient started hallucinating, and has urinary tract infection manifested by an odor and painful urination. Treatment for events were not provided. Patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable. The outcome of the events, hallucinations, urinary tract infection, were not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,02/20/2021,29.0,UNK,ASPIRIN 81; VITAMIN D3; VITAMIN B12 NOS; ARICEPT; LEVOTHYROXINE; MELATONIN; PRILOSEC [OMEPRAZOLE]; PERMETHRIN CREAM; HYDROCORTISONE CREAM,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Hallucination', 'Urinary tract infection']",1,MODERNA, 1069057,,,F,"left side neck pain; numbness and tingling on the left side of my body; tingling in my fingertips (both hands); very tired; muscle aches; low grade fever; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events( hemidysaesthesia, paraesthesia, neck pain, fatigue, myalgia, pyrexia). The patient's medical history was not provided. No relevant concomitant medications were reported. On jan142021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(Lot/batch: unknown) intramuscularly in the anatomical location for the prophylaxis of COVID-19 infection. On 21jan2021 the patient experienced the event hemidysaesthesia with medically significant seriousness criteria. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event was unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced medically significant and serious unexpected event of hemidysaesthesia along with a NS unexpected neck pain, paraesthesia and NS expected pyrexia, fatigue, myalgia. The events occurred 8 days after the first dose of mRNA-1273. Treatment and event resolution not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Fatigue', 'Hemidysaesthesia', 'Myalgia', 'Neck pain', 'Paraesthesia', 'Pyrexia']",1,MODERNA, 1069067,OH,68.0,F,"Patient was being monitored post-vaccine for 30 minutes. At approximately the end of her monitoring period, the patient C/O of extreme ""sleepiness."" Stated it was hard for her to stay awake. Altered mental status.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/12/1953,03/02/2021,24855.0,PUB,"Zonegran, Klonopin, Cymbalta, Hydrodiuril, Atarax, Advil, Synthroid, Estrace, Ambien, Vitamin B12, Neurontin, Melatonin, Multiple Vitamin, Calcium Citrate",,"AKI, allergic rhinitis, anxiety, chronic back pain, abdominal blood clots after pregnancy (age24), depression, endometriosis, GERD, H/O cardiac cath, HTN, hypothyroidism, lumbar radiculopathy, OSA, OA, pancreatitis,, S/P bariatric surgery, restless legs syndrome. sleep apnea.",,"Morphine, Sulfa, PCN","['Mental status changes', 'Somnolence']",1,MODERNA,IM 1069076,SD,63.0,M,"Fever, cough and loss of taste. Low O2. Patient transferred",Not Reported,,Not Reported,Yes,,Not Reported,N,02/25/2021,03/01/2021,4.0,PVT,Admitted to the hospital for Covid. Multiple meds are on board,,,,,"['Ageusia', 'Cough', 'Oxygen saturation decreased', 'Pyrexia']",1,MODERNA,IM 1069083,WV,86.0,F,"Left sided numbness, tingling of face, arm and leg. Loss of hearing in left ear. Called 911. Air rescue to Hospital. Workup labs, CT, MRI and carotid ultrasound. Symptoms resolved 5 hours.",Not Reported,,Yes,Yes,1.0,Not Reported,U,02/04/2021,02/17/2021,13.0,PUB,Blood pressure medications,Hypertension,,,,"['Computerised tomogram', 'Deafness', 'Hypertension', 'Hypoaesthesia', 'Laboratory test', 'Magnetic resonance imaging', 'Paraesthesia', 'Ultrasound Doppler']",2,PFIZER\BIONTECH,IM 1069086,MD,82.0,F,"Patient presented to ED with chest pain on her right breast radiating to the back intermittently. No associated N/V, diaphoresis, or SOB. Pt was started on a heparin drip but was later discharged home after being cleared by cardiology. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/26/2021,02/26/2021,0.0,PVT,,,"Type 2 DM, hypothyroidism, CKD, HTN",,,"['Back pain', 'Breast pain', 'Chest pain', 'Pain']",1,PFIZER\BIONTECH,IM 1069118,IL,72.0,F,"Within 10 minutes following the second vaccination, patient reported dizziness and nausea, had an episode of vomiting but recovered within 30 minutes. It was reported to our clinic that the patient was found deceased on March 1, 2021 at approximately 10 pm. Cause of death is not determined at this time.",Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,U,02/25/2021,03/01/2021,4.0,PVT,"albuterol sulfate, Aspir-81, bethanechol chloride, Bevespi, Aerosphere, cholestyramine (with sugar), citalopram, clopidogrel, duloxetine, famotidine, gabapentin, lisinopril, magnesium oxide, megestrol, metoprolol tartrate, mupirocin, nitrog",First covid vaccine received 1/28/2021 without incident. Had been hospitalized prior to vaccination for intractable vomiting.,"history of acute respiratory failure, carotid artery stenosis, chronic back pain, chronic esophagitis, chronic hyperglycemia, chronic obstructive lung disease, chronic sinusitis, coronary arteriosclerosis, depressive disorder, exposure to SARS-CoV-2, history of polyp of colon, hyperlipidemia, hypertensive disorder, hypoxia, nicotine dependence, non-small cell lung cancer, osteoarthritis, peripheral nerve disease, peripheral vascular disease, tremor",,"codeine, Zithromax","['Death', 'Dizziness', 'Nausea', 'Vomiting']",2,MODERNA,IM 1069125,MD,76.0,F,"Patient was admitted with impression of COPD exacerbation and hypoxia. She was treated with antibiotic and bronchodilators. Her symptoms gradually improved and she was discharged. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,02/26/2021,02/26/2021,0.0,PVT,,,"Hx of lung cancer, COPD, nicotine dependence, HTN, GERD, type 2 diabetes, CAD, hx of breast cancer",,,"['Chronic obstructive pulmonary disease', 'Hypoxia']",1,PFIZER\BIONTECH,IM 1069132,LA,74.0,M,"Generalized weakness, unable to walk. Chills. Temp 99.4 Admitted to hospital given IV saline and supportive care. Discharge on second day.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/19/2021,02/20/2021,1.0,PVT,mupirocin (BACTROBAN) 2 % Ointment Apply to affected area daily. 30 Gram None ? lactulose (ENULOSE) 20 gram/30 mL Take 30 mL by mouth daily. 250 mL 0 ? polyethylene glycol 3350 (MIRALAX) 17 gram/dose Powder Take 1 SCOOP (17 Grams) by mouth,none,Atrial fibrillation � ? Benign prostatic hypertrophy � ? CAD (coronary artery disease) � ? COPD (chronic obstructive pulmonary disease) � ? Diabetes mellitus � ? Greenfield filter in place � ? HTN (hypertension) � ? Hyperlipidemia � ? Hypothyroidism � ? MI (myocardial infarction) 2003 ? Thromboembolism,,Levofloxacin Diarrhea � � Other reaction(s): diarrhea ? Sulfa (Sulfonamide Antibiotics) Hives and Rash ? Dronedarone Nausea and Vomiting and Other (See Comments) � � diarrhea diarrhea ? Orange Blossom Hives ? Penicillins Hives,"['Alanine aminotransferase normal', 'Aspartate aminotransferase normal', 'Asthenia', 'Basophil count normal', 'Bilirubin urine', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bilirubin normal', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine normal', 'Blood glucose normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea normal', 'Blood urine absent', 'Body temperature increased', 'Carbon dioxide normal', 'Chest X-ray', 'Chills', 'Chromaturia', 'Differential white blood cell count normal', 'Eosinophil count normal', 'Eosinophil percentage', 'Full blood count', 'Gait inability', 'Glomerular filtration rate normal', 'Glucose urine absent', 'Haematocrit decreased', 'Haemoglobin normal', 'International normalised ratio increased', 'Lymphocyte count', 'Lymphocyte count normal', 'Mean cell haemoglobin concentration', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Mean platelet volume normal', 'Metabolic function test', 'Monocyte percentage increased', 'Neutrophil count normal', 'Neutrophil percentage', 'Nitrite urine absent', 'Platelet count decreased', 'Protein total normal', 'Protein urine absent', 'Prothrombin time prolonged', 'Red blood cell count decreased', 'Red cell distribution width increased', 'Red cell distribution width normal', 'SARS-CoV-2 test negative', 'Specific gravity urine normal', 'Troponin I normal', 'Urine analysis', 'Urine ketone body absent', 'Urine leukocyte esterase', 'Urobilinogen urine increased', 'White blood cell count normal', 'pH urine normal']",2,MODERNA, 1069140,PR,75.0,M,"The day after the administration of the vaccine, the fever began, the patient claim that he had no blood pressure problems. He was given acetaminophen every 4 hrs. and vitamin C and D. On February 11, he was stabilized, he had his regular meals without any problem but in the afternoon his temperature rose again and they put him to bed. The patient died that same afternoon around 4:00 pm",Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/10/2021,1.0,SEN,"Bacofleno, Agrenox, Synthroid, Fenofibrate, Busoiron, Lasix, Lipthol, Amiodarone, Clonopin",None reported,"Hypertension, stroke, pacemaker",,None reported,"['Death', 'Pyrexia']",2,MODERNA,IM 1069167,MA,65.0,F,Approximately 16 hours after receiving 1st Moderna COVID vaccine I became dizzy (could not lie down) and felt nauseous. Felt unsteady and weak. Taken to Urgent Care facility where my BP registered 200/100. I was given nitroglycerin and an aspirin and taken by ambulance to the nearest hospital where I spent two nights.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/27/2021,02/28/2021,1.0,UNK,Calcium 600+D+plus Minerals Osteo Bi-Flex Magnesium 500 mg,None,None,,Shrimp Bee Stings,"['Asthenia', 'Balance disorder', 'Blood test', 'Computerised tomogram', 'Computerised tomogram head', 'Computerised tomogram neck', 'Computerised tomogram spine', 'Dizziness', 'Electrocardiogram', 'Magnetic resonance imaging head', 'Nausea']",1,MODERNA,IM 1069173,AK,62.0,M,"Moderna COVID-19 Vaccine EUA 5-10 minutes after receiving the vaccine the following symptoms were experienced: Dizziness, weakness, brain fog, breathing difficulties, lowered O2 saturation, nausea, elevated BP and elevated / thready pulse. O2 was administered, I was placed in a response room and monitored by staff nurses (RN and LPN's) MD checked on progress. O2 saturation returned to 100% after 15 minutes and an EPI pen was determined to be not required. Walked out of the hospital 2 hours after administration of the vaccine.",Not Reported,,Yes,Not Reported,,Not Reported,Y,03/01/2021,03/02/2021,1.0,PVT,Loratidine 10 mg x 4/day Tylenol as needed,None,Food Allergy's,,"Multiple food allergies, suspected latex and nickel","['Asthenia', 'Blood pressure increased', 'Dizziness', 'Dyspnoea', 'Feeling abnormal', 'Heart rate increased', 'Nausea', 'Oxygen saturation decreased', 'Pulse abnormal']",1,MODERNA,IM 1069211,AR,73.0,M,"Patient had immediate severe pain in the affected arm. Pain started hours after receiving the vaccine and has continued for over one month. Pain has affected his daily activities. After several days of applying warm compresses and taking over the counter anti-inflammatory medications without relief, patient sought medical care. Patient has since continued to follow up with Dr. at the facility and is undergoing physical therapy sessions as well as new medications. As of today, 3/3/21, patient still has pain in his arm that limits daily acitivities.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/05/2021,02/05/2021,0.0,PVT,,,,,,"['Loss of personal independence in daily activities', 'Pain in extremity']",2,PFIZER\BIONTECH,SYR 1069220,OH,58.0,F,"Chills x 3 days and then fever, emesis, diarrhea and shortness of breath",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,12/30/2020,01/08/2021,9.0,WRK,Crestor 10mg q day ASA 325 mg q day Lexapro 10mg q day,No e,None,,None,"['Blood culture', 'Blood lactic acid', 'Brain natriuretic peptide', 'C-reactive protein', 'Chest X-ray', 'Chills', 'Computerised tomogram', 'Condition aggravated', 'Culture urine', 'Diarrhoea', 'Dyspnoea', 'Echocardiogram', 'Electrocardiogram', 'Fibrin D dimer', 'Lipase', 'Metabolic function test', 'Procalcitonin', 'Pyrexia', 'SARS-CoV-2 test', 'Troponin', 'Urine analysis', 'Vomiting']",1,PFIZER\BIONTECH,IM 1069235,AK,89.0,M,Death,Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,02/28/2021,52.0,SEN,"Morphine, Lorazepam, Haloperidol, Loperamide, Ondansetron","Dementia, Anxiety, Hypokalemia, Peripheral Vascular disease, HTN, Absence of part of Lung Z90.2, BPH, Hypomagnesemia,","Dementia, Anxiety, Hypokalemia, Peripheral Vascular disease, HTN, Absence of part of Lung Z90.2, BPH, Hypomagnesemia,",,"Amoxicillin, Azithromycin, Notriptyline, Augmentin",['Death'],2,PFIZER\BIONTECH,IM 1069245,IL,69.0,M,Patient received his second COVID pfizer vaccine on 2/27 and 10:30 AM. Several hours after receiving the vaccine pt become more lethargic with increased AMS and reached a fever of 103 and came to the emergency room on 2/28 around 3 AM. Pt had a prolonged course of COVID in May 2020. All other infections ruled out and pt now stable. However this is believed to be febril illness post-COVID vaccination,Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,02/27/2021,02/27/2021,0.0,PVT,Aspirin 81 mg chewable tablet Hydroxyzine 25 mg tablet ProAir inhaler Apixaban 5 mg daily Insulin lispro Trazadone Losartan hydralazine Quetiapine Tacrolimus Prednisone simvastatin tamsulosin,,"Medical history of type II diabetes, hypertension, heart failure, CAD, renal transplant, and depression",,None,"['Blood culture negative', 'Chest X-ray abnormal', 'Computerised tomogram abdomen normal', 'Computerised tomogram head normal', 'Computerised tomogram thorax normal', 'Culture urine negative', 'Lethargy', 'Lung infiltration', 'Mental status changes', 'Pyrexia', 'Urine analysis normal']",2,PFIZER\BIONTECH,IM 1069263,FL,83.0,M,DIED,Yes,02/16/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/16/2021,5.0,UNK,,DIABETIS,,,,['Death'],UNK,PFIZER\BIONTECH, 1069271,TX,58.0,M,2/11/21 wife and I both took 1st Vaccine Shot 2/23/21 Wife and I Both Tested Positive for Covid. Oxvgen level for patient 93. X-RAY SHOW COVID SPREAD 2/24/21 Admitted to (hospital). Low Oxygen/elevated heart enzymes 2/25/21 Released with Oxygen,Not Reported,,Yes,Yes,1.0,Not Reported,N,02/11/2021,02/18/2021,7.0,OTH,Lisinopril-hydrochlorothiazide 20-25 mg tablet. Metoprolol succinate XL 50 mg tablet Omeprazole 40 mg capsule aspirin EC 81 EC tablet,none,none,,none,"['COVID-19', 'Computerised tomogram', 'Electrocardiogram', 'Myocardial necrosis marker increased', 'Oxygen saturation decreased', 'SARS-CoV-2 test positive', 'X-ray abnormal']",1,MODERNA,IM 1069287,,34.0,F,Ringing in both ears - tinnitus!,Not Reported,,Not Reported,Not Reported,,Yes,N,01/30/2021,01/31/2021,1.0,PUB,,,,,,"['Acoustic stimulation tests normal', 'Tinnitus']",1,PFIZER\BIONTECH,SYR 1069314,KY,59.0,F,Tested positive for COVID19 12/01/2020 both vaccinations received and pt has now tested positive for COVID19 again on 03/02.,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/20/2021,02/10/2021,21.0,SEN,UK,"Hx of aspiration pneumonia with respiratory distress, hx of CVA, COPD","COPD, CVA, anxiety, bipolar, smoking",,"Benadryl, Celebrex, Cymbalta, Lyrica, Risperidone, Vioxx","['COVID-19', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1069316,TN,57.0,F,death,Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/21/2021,9.0,SEN,unknown,unknown,unknown,,unknown,['Death'],2,MODERNA,SYR 1069317,GA,70.0,F,"PATIENT STATED TINGLING SENSATION ABOUT 15 MINUTES AFTER IMZ GIVEN, THEN SYNCOPE, THEN LOSS BODY FUNCTION 10 MINUTES LATER. CONSCIOUS ENTIRE TIME, ABLE TO BREATH ON OWN",Not Reported,,Not Reported,Yes,,Not Reported,U,03/03/2021,03/03/2021,0.0,PHM,NONE,NONE,"DIABETIC, ASTHMA, HYPERTENSION, CANCER REMISSION",,EGGS,"['Muscle disorder', 'Paraesthesia', 'Syncope']",1,MODERNA,IM 1069321,CA,29.0,M,"Chills, anxiety, cold, clammy, chest tightness, SOB",Not Reported,,Not Reported,Yes,,Not Reported,U,02/26/2021,02/26/2021,0.0,OTH,Unknown,"Anxiety, Depression","Anxiety, Depression",,NKA,"['Anxiety', 'Chest discomfort', 'Chills', 'Cold sweat', 'Dyspnoea', 'Nasopharyngitis']",2,PFIZER\BIONTECH,IM 1069465,LA,78.0,M,"March 3, 2021 SUBJECT: Moderna COVID-19 Vaccine, Side Effects This letter/email is addressed to a number of individuals with a request that you seriously evaluate the below discussion, take action to alert medical staff of your respective agencies of these side effects, and work with the manufacturer, Moderna, to address them. As the recipient of them it has thus far been debilitating and interfered with my daily activities. It is my hope that the medical community can find ways to prevent or treat them such that daily activity can be unimpeded. I will first provide a chronology of my medical history and my Moderna vaccine experience. Then I will discuss my observations. My medical history: Age: 78 Gender: Male Pre-existing Conditions: Medications Hypertension: Blood pressure medication, 50 mg of Metoprolol Succinate ER daily Cholesterol: Atorvastatin, 40 mg daily Medical History 2018: Triple By-Pass Surgery 2019: Passed out, Hit head on falling, Brain bleed: Subdural Hematoma, Hospitalized: No surgery required and released. Subsequently, pacemaker installed. 2021: Moderna COVID-19 Vaccine administered. First Dose: Lot Number: 011J20A, Date: 01/08/2021, Clinic Site: Pharmacy Second Dose: Lot Number: 032L20A, Date: 02/05/2021, Clinic Site: Pharmacy Side Effects to Moderna Vaccine administration First Dose: Administration Site: Swelling, Site Redness and Fever. All dissipated within week after administration Second Dose: Fever and Chills day following administration. Lethargic for several days following administration. These symptoms disappeared. Observations February 24, 2021: Began to experience dizziness, symptoms progressed to mild vertigo. Based on history of presentation of these symptoms, assumed I had an inter-ear problem and began taking Zyrtec D, half a tablet. Experience with Zyrtec D has been that ear dries out and symptoms of dizziness and disorientation disappear. In this case the symptoms of vertigo progressed to the point of difficulty in walking and loss of balance. Stopped taking Zyrtec D on Friday, February 26th. February 26, 2021: Had more severe vomiting, walking difficulty and lose of balance. Used walker to stabilize walking. At approximately 7 to 7:30 PM, following consultation with wife and daughter, decided to go the emergency room of the Medical Center (MC). Was quickly seen by emergency room staff. Following questions on medical history, the ER doctor, based on head bleed history, I believe, had a CT conducted. I do not recall any questions about COVID-19, but do think we told them that both myself and my wife had been vaccinated for COVID-19. I specifically recall that prior to my transport, a nurse came in to do a nasal swab for COVID-19. I informed her that I had been vaccinated, but she said this was a requirement for admission to the location where I was being transported. Following the CT scan, the ER physician determined he believed there was a possibility of a small new brain bleed. At approximately 2 to 2:30 AM I was transported by ambulance to Health Center at approximately 5:00 AM. I am not certain about the exact times here. February 27, 2021: Health Center administered a number of tests including CT scan, EKG, and an echocardiogram. While there, physical therapists came to see me twice and exercised me to improve my balance and walking ability. The last one recommended exercises to help reset my vestibular system. Based on the administered CT scan there, the physicians saw no evidence of a new brain bleed and were prepared to release me. At the time of that discussion in my room, the attending nurse pointed out to the physician there that my blood pressure was elevated. He ordered a new EKG and deferred on releasing me until a cardiologist reviewed the results. Their concern was that I was experiencing episodes of atrial fibrillation (AFib). Subsequently, the cardiologist reviewed the new EKG and concluded the episodes were within the normal range, my understanding, but did note that my heart rate was elevated. At no time did the medical staff raise or question the possibility of COVID-19 side effects as being a possible explanation for my disorientation or heart rate problem. I was released later that day. February 28, 2021: While speaking to her sister, my wife shared with her my experience of dizziness and disorientation. Her sister related that her husband had and was experiencing a similar event. Further, her husband?s sister had experienced a similar event. Additionally, the husband?s sister had experienced vertigo. On further discussion it was determined all three of us had received the Moderna Vaccine, and approximately three to four weeks post second dose administration, developed these symptoms of vertigo. This prompted me to go to the internet for information on vaccine side effects. The Food and Drug Administration Fact Sheet, revised 12/2020 in the Section Titled: What are the risks of the Moderna COVID-19 vaccine? speaks of severe allergic reactions including: a fast heartbeat and dizziness and weakness. I believe that I have suffered these two reactions. March 1, 2021: Called both hospitals to alert them to inform their respective staffs of the need to question the possibility of these side effects should other patients present in their emergency rooms. In my case, it may have helped to alleviate my concerns had I been informed of these possible side effects. At MC I left a voice mail for the Chief Medical Officer and at Health Center I spoke to the Nursing Supervisor. The nursing supervisor advised me to report my side effects and directed me to call the entity who had administered the vaccine doses. I called the Pharmacist and spoke to her. She said she would report my concerns through her reporting system. Further she informed me that there was a medication my primary care provider could prescribe. I called my primary care provider, and he has prescribed Meclizine, 25 mg tablets. I am currently taking � tablet, three times per day. A whole tablet made me drowsy. As of today, March 3, 2021, I am still experiencing disorientation. Hopefully this will subside and disappear. The above discussion is provided to assist medical professionals to further assess the side effects of the Moderna COVID-19 Vaccine. I am glad that I received it. I have no complaint about the care I received at the two medical facilities referenced. In fact, I think it was excellent. However, it would have helped me to have raised by either or both of them that my symptoms may have been COVID-19 Vaccine related. Further, it may have changed how they proceeded in assessing my situation. As an industrial hygienist with statistical training, it seems to me somewhat unusual to have three members of my extended family experiencing similar dizziness and weakness side effects, and for us all to have similar time periods following the administration of the second dose. Perhaps, if related to the vaccine, this cluster would suggest that this side effect may be more common than a ?remote chance.? Should any of you have further questions or wish to speak to me, please do not hesitate to call. Since I get a lot of calls from numbers I do not recognize, I do not always answer, but a voice mail left with a return call number normally results in a return call. Today, I received a return call from the Chief Medical Director of MC and told her she would receive a copy of this document. Thank you for your attention to this matter.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/05/2021,02/24/2021,19.0,PHM,See below,See below,See below,,See below,"['Asthenia', 'Balance disorder', 'Blood pressure increased', 'Chills', 'Computerised tomogram', 'Disorientation', 'Dizziness', 'Ear disorder', 'Echocardiogram', 'Electrocardiogram', 'Gait disturbance', 'Heart rate increased', 'Lethargy', 'Pyrexia', 'SARS-CoV-2 test', 'Vertigo', 'Vestibular disorder', 'Vomiting', 'Walking aid user']",2,MODERNA,IM 1069513,HI,68.0,F,None at the time of vaccination. Pt admitted to ER on 2/25 with chest pain.,Not Reported,,Not Reported,Yes,8.0,Not Reported,,01/26/2021,02/25/2021,30.0,PVT,Metformin Gentamicin eye drops Irbesartan Ibuprofen Vascepa Atorvastatin,Aortic stenosis Asthma BMI 26-26.9 Calculus of L ureter Colitis Diabetes Essential tremor H/O tubal ligation HTN Hx appendectomy Hx degenerative disc disease Hyperlipidemia Nephrolithiasis Obesity Polycythemia,As above,,Erythromycin Tramadol Visken,"['Aortic stenosis', 'Aortic valve replacement', 'Catheterisation cardiac abnormal', 'Chest pain', 'Coronary artery bypass', 'Coronary artery disease']",2,PFIZER\BIONTECH,IM 1069520,LA,52.0,F,"Anaphylaxis. 2 EpiPens, 50 mg Benadryl PO. Was with patient for 2 hours before ambulance arrived. Tingling and numbness to lips, tongue and mouth. Swelling of lips. Pruritis of throat. Dry unproductive cough. ""Feel like I'm being strangled"". Grogginess (may have been due to Benadryl). Disorientation. Increase in blood pressure. Increased respiratory rate and labored breathing. Left chest discomfort (non-radiating). Hoarseness. Appeared syncopal and weak.",Not Reported,,Yes,Yes,1.0,Not Reported,U,02/26/2021,02/26/2021,0.0,SCH,Advair Diskus albuterol sulfate cephalexin doxycycline hyclate fluconazole fluoxetine fluticasone propionate methylprednisolone nitrofurantoin monohyd/m-cryst phenazopyridine promethazine gel 25mg/ml,,Asthma,,"Morphine, Ciprofloxacin, Bactrim","['Anaphylactic reaction', 'Asthenia', 'Blood pressure increased', 'Chest discomfort', 'Cough', 'Disorientation', 'Dysphonia', 'Dyspnoea', 'Feeling abnormal', 'Hypoaesthesia oral', 'Lip swelling', 'Paraesthesia oral', 'Pruritus', 'Respiratory rate increased', 'Somnolence', 'Syncope', 'Throat irritation', 'Throat tightness']",1,MODERNA,IM 1069536,ID,47.0,F,"SEVERE swelling of tongue, lips, mouth lining, throat; ""waxy coating feeling"" in lungs - began 20 minutes after vaccination to 4 days after - went to Emergency Department at 30 minutes after vaccination and received IV medication and epipen shot to R thigh. Subsided before leaving ED, but returned in more mild state the next day - managed by OTC Benadryl and allergy meds. Symptoms returned again at approx 39 hours and returned to Emergency Department again for more IV medications. Asthma attacks - started in the Emergency Department on first day and have continued to today 3/3/2021. Prior to vaccination, I used inhaler approx 1x every 60 days at most. Have gone more than a year without using one. After vaccination, used inhaler the same evening and then 12 times the next day, and several times before going to ED again, and have had to use it daily since. This morning 3/3/2021, woke at apprise 2:30-3:00 am with an attack that needed 2 doses to subside, and then again at 8:30 this am about 1.5 hours after waking. Burning on tongue with sores on outer sides, metallic/burning/no taste - began 20 minutes after vaccination continuing to today. Rash on face - began in Emergency Department on first day and continues to today. Began using Cortizone yesterday 3/3/2021. Rash and hives on neck, chest - began in Emergency Department on first day and subsided next day after allergy medications in ED and OTC allergy medications that night. Headache - sudden onset 25 minutes after vaccination. Returned that evening after first ED visit. Returned the following day. Returned the third day. Subsided the fourth day. Used ibuprofen and acetaminophen to manage.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/06/2021,02/06/2021,0.0,PVT,"All of these stopped that same day because of adverse reaction. Last taken the night before. Valsartan 160mg Trazodone 50mg Vitamin E 1000u Flaxseed 1000u Vitamin D3 10,000u Multivitamin 1 cap",None,Diabetes Hypertension,minor reaction to tetanus shot - hardness under skin and minor swelling at injection site that alleviates within 48 hours.,Penicillins: anaphylactic shock,"['Ageusia', 'Asthma', 'Blood glucose increased', 'Blood test abnormal', 'Circumoral swelling', 'Dysgeusia', 'Glossodynia', 'Headache', 'Lip swelling', 'Mouth swelling', 'Pharyngeal swelling', 'Rash', 'Respiratory tract irritation', 'Swollen tongue', 'Tongue discomfort', 'Tongue ulceration', 'Urticaria']",1,MODERNA,SYR 1069560,NY,61.0,M,"Hospital course 1/31 ? 2/20/21 1/31 in ED pt was at home when children noticed his lips were blue, ems arrived and found him to be 50% on RA, on Non-rebreather pt got to 78%, covid on 01/26 Shortness of Breath 61-year-old male presents with EMS for evaluation of shortness of breath hypoxia. History is limited due to the patient's current clinical condition and so is primarily obtained from EMS. EMS reports that he tested positive for COVID-19 5 days ago. He began developing shortness of breath yesterday and his family called because his lips and fingers were blue today and he appeared short of breath. On EMS arrival he had a room air saturation of less than 50% so he was placed on nonrebreather with improvement in his saturation to 70% and he was transported to the emergency department. Patient does admit to shortness of breath. He denies any chest pain. He is noted to have a cast on his left ankle and said that he broke his left ankle on 23 December but has not had surgery. He denies any new pain or swelling of the leg. In the ED he was placed on 15L nasal cannula and NRB mask with improvement in SPO2 to low 90s. Additional work up revealed troponin of 1.35, lactic acid 5.8, and d-dimer 14.4. He received dexamethasone and was placed on heparin gtt. 1/31 admitted to ICU Acute hypoxic respiratory failure due to COVID-19 vs heart failure vs PE. CXR with bilateral hazy infiltrates more pronounced in the bases and left periphery and suspected multifocal pneumonia. At risk for PE given LLE immobility in the setting of COVID-19 with significantly elevated d-dimer. RISK of CTA outweighs benefit given AKI and iodine allergy. Continue with empiric treatment with heparin gtt. Admitted to ICU with SO2 in 60s-70s on 15L and NRB. Attempted 50L 95% FIO2 high flow and nasal cannula. Given lasix 40mg IV with good diuresis however SPO2 still remained low 80s with RR 40s and PO2 42 so the decision was made to intubate. Oxygenation improved following intubation, with further improvement following recruitment maneuver and increase in PEEP. FIO2 weaned to 90% with SPO2 remaining in mid 90s. Will continue to wean FIO2 as able. ARDS net protocol as much as possible. Consider prone ventilation and/or epoprostenol if unable to improve . VAP Bundle: HOB >30 degrees; Oral care per nursing standard and on DVT/PPI prophylaxis Sedation: Target Richmond Agitation and Sedation Scale (RASS) of 0 to -2 with propofol and fentanyl. Check baseline TG levels. COVID - 19: Convalescent plasma: Not indicated Steroids: Dexamethasone 6 mg / day for 10 days Remdesivir: Not indicated d/t AKI IL-6 inhibitor: Meets criteria for tocilizumab Systemic AC: Heparin gtt. No signs of bleeding (Platelets and Hb stable). Antibiotics: Start 3 and 7 day course of azithromycin and ceftriaxone, respectively. Elevated troponin Suspect demand ischemia d/t hypoxia; EKG does not show any ischemic changes AKI: Suspect d/t hypoxia in the setting of COVID infection. Urine output and electrolytes acceptable. Closed fracture of left ankle Suffered fracture following a fall on ice in December. Cast was placed on 12/30 by SOS. He was due to be re-evaluated this week for possible cast removal. Inhaled epoprostenol started Considered for ECMO but not initiated due to not a candidate Vasopressors required at times Antihypertensive infusion required at times severe hypoxia with position changes switched from heparin drip to enoxaparin prophylaxis 2/20 discharge summary 61 y/o male admitted to Hospital on 1/31 with hypoxia. He was diagnosed with COVID 19 5 days prior to admission, and had worsening respiratory status. He was intubated after arrival, and was on ventilator for the entire intervening time, until he was extubated on 2/20 at the time of transition to Comfort measures only. Prior to developing COVID 19, he had received his first dose of the Pfizer vaccine, as a member of the school system. He had a fractured L ankle after a fall on 12/31/20, and had a cast in place at the time of admission. He received Tocilizumab on 1/31, and underwent several cycles of prone positioning, beginning on 2/2. He completed a course of Decadron, he received Ceftriaxone and azithromycin beginning on admission, and completed a course of these. Anticoagulation with enoxaparin was utilized due to coagulopathy associated with COVID 19. Vasopressor support was required at times, as well as diuresis for fluid management. He required high levels of sedation to maintain ventilator synchrony, and high levels of ventilator support with high oxygen levels throughout his stay. Tracheostomy was being considered, but family decided that since he was not going to have good recovery, withdrawal of support, and allowing death was the appropriate choice for the patient and for them. He was extubated at 2100 on 2/20/2021. Death was pronounced at 2123 on 2/20/2021. Children were at bedside.",Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/31/2021,16.0,UNK,Albuterol MDI Robitussin DM TheraFlu cough & cold,Ankle fracture,"Past medical history Ankle fracture, left 12/30/2020 Asthma Diabetes mellitus Hypertension Obesity 104.3kg; Height 5?6?",,Iodine ? hives Shellfish - hives,"['Acute respiratory failure', 'Blood lactic acid increased', 'COVID-19', 'Cardiac failure', 'Chest X-ray abnormal', 'Cyanosis', 'Death', 'Dyspnoea', 'Electrocardiogram abnormal', 'Electrocardiogram normal', 'Endotracheal intubation', 'Fibrin D dimer increased', 'Intensive care', 'Lung infiltration', 'Myocardial ischaemia', 'Pneumonia', 'Pulmonary embolism', 'Respiratory arrest', 'SARS-CoV-2 test positive', 'Skin discolouration', 'Troponin increased', 'Urine electrolytes normal']",1,PFIZER\BIONTECH,UN 1069567,SD,85.0,M,"Patient experienced sweats, fevers, and extreme weakness with difficulty ambulating the afternoon after second COVID vaccine. Patient was admitted to the hospital overnight for observation and was given tylenol to help with fevers, was discharged the following day.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/22/2021,02/23/2021,1.0,PVT,"tyelnol, atorvastatin, imdur, tamsulosin, effexor-xr, ASA, multivitamin, CO Q10, glucosamine condroitin",none,"Anxiety, depression, BPH, dementia, history of elevated PSA, hx of fatigue, hx of hypotension and hypertension, peripheral neuropathy",,NKA,"['Asthenia', 'Blood lactic acid', 'Full blood count', 'Gait disturbance', 'Hyperhidrosis', 'Metabolic function test', 'Myoglobin blood', 'Pyrexia', 'SARS-CoV-2 test', 'Troponin']",2,MODERNA,IM 1069570,CA,69.0,F,"2nd dose of Moderna at 9:00am. No side effect (except pinch at injection site) throughout the day and evening. At ~9:45pm, my wife suddenly fell unconscious. Immediate CPR & with Paramedic were not able to revive her. SHE PASSED AWAY at home. We believe it may be triggered by the vaccine. Did not have a chance to go to hospital or emergency room - it was too sudden. A sad day for us.",Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,PVT,"No prescriptions Vitamins: C, E, Fish Oil, CoQ10, Black Garlic, & Iron.",None,High Cholesterol level.,,None,"['Death', 'Injection site discomfort', 'Loss of consciousness', 'Resuscitation']",2,MODERNA,SYR 1069592,FL,77.0,F,Acute onset rep distress,Not Reported,,Yes,Yes,2.0,Not Reported,U,03/01/2021,03/02/2021,1.0,OTH,"amlodipine, doxepin, meloxicam, pravastatin, tramadol, trazodone",denied,diabetes HTN,,nkda,"['Intensive care', 'Respiratory distress']",1,MODERNA,IM 1069614,WV,59.0,F,"48 hours after receiving dose 2 of the Moderna vaccine, patient developed alterations in mental status - cannot recall the events. She was taken to the ED and was found to have a BP of >200/130. Patient had a seizure in the ED - was intubated to protect airway. CT showed some decreased areas of attenuation in the bilateral occipital lobes and cerebellum. MRI showed vasogenic and cytotoxic edema in posterior temporal, parietal and BL occipital and BL cerebellar hemisphere which can be seen with PRES. Patient required inpatient treatment for her elevated BP and neurological evaluation. Was started on Norvasc and Keppra due to concern for PRES. Discharged with follow up in cancer center and with neurology. Hospitalist and neuro teams thought PRES was likely due to her chemo regimen, patient's oncology team though PRES may have been triggered by vaccine due to timing and her dose of Avastin. Pt has extensive oncological history including ovarian cancer w/ metastatic breast cancer in L axilla. Pt recently started on cytoxan, Avastin, pembrolizumab. Also has malignant abdominal ascites.",Not Reported,,Yes,Yes,8.0,Not Reported,Y,02/18/2021,02/20/2021,2.0,PVT,"Avastin, Cytoxan, Pembrolizumab, levothyroxine, Nexium, Magnesium Oxide, Senokot",Metastatic ovarian cancer to breast under active chemo/immunotherapy,"Hypothyroidism, T2DM, HTN",,No known,"['Ascites', 'Blood pressure increased', 'Cerebral calcification', 'Computerised tomogram abnormal', 'Cytotoxic oedema', 'Endotracheal intubation', 'Magnetic resonance imaging abnormal', 'Malignant ascites', 'Mental status changes', 'Neurological examination', 'Posterior reversible encephalopathy syndrome', 'Seizure']",2,MODERNA,UN 1069619,WI,69.0,M,"Around 9:55 pm on 2/27/2021 client took Afrin nasal spray for nasal congestion. About 5 minutes later (10:00 pm) client states he went into anaphylactic shock. The ambulance was called by his wife. Per client, her received infusions of epi and Benadryl from ambulance staff. Client was taken to Hospital for further treatment. He was subsequently transferred to Heart Hospital for overnight observation due to possible heart issues. Note: Client has take Afrin nasal spray for over 30 years and has never had a reaction.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/26/2021,02/27/2021,1.0,PUB,Lisinopril daily: usually after lunch Afrin nasal spray PRN for nasal congestion (took at 9:55 PM on 2/27/2021,none,hypertension,,Seasonal hay fever,"['Anaphylactic shock', 'Nasal congestion']",2,MODERNA,IM 1069632,MN,55.0,M,"Presented to ED for evaluation of generalized lower extremity weakness, falls. The patient states that he carries a diagnosis of MS and typically is fully functioning without assistance of a cane or walker. The patient states that yesterday morning around 0900 he received the second dose of his Moderna COVID-19 vaccine and was otherwise feeling fine but by last night (12 hours after the vaccine) the patient states he tried to get out of bed and was transferring when he felt his bilateral legs give out, causing him to slide to the ground. His wife then came to help and states that the patient was completely weak in the legs, and was unable to even lift his legs up to get back into bed. They then tried to walk him again a short time later and he again stumbled with weakness in his legs. Since that time, the patient states he has been minimally ambulatory and has been using a cane, but still needs large assistance to get around his home. The patient states he has baseline foot drop but feels this is worse in his legs today. He went to clinic this morning for his symptoms where he was noted to have an elevated temperature and was diffusely weak in his lower extremities. Given this, the patient was referred to the ED for further evaluation. The patient denies any weakness in his upper extremities or facial asymmetry. He denies sensation change in his extremities nor any recent illness such as cough, shortness of breath, chest pain, sore throat, nausea, vomiting, urinary symptoms, or leg pain. He has no history of stroke. He denies any injuries or head injury, syncope from his falls. He was admitted to the hospital where he will receive further symptomatic treatment as necessary. No treatment provided in emergency department for weakness.",Not Reported,,Not Reported,Yes,,Not Reported,U,03/02/2021,03/02/2021,0.0,PVT,"alprazolam prn, armodafinil 250 mg daily, brexipiprazole 3 mg daily, cetirizine 10 mg daily, vitamin D, dalfampridine 10 mg BID, lamotrigine 150 mg am, 300 mg pm; levomilnacipram 80 mg daily, ocrelizumab infusion every 6 monhts, omeprazole",,"MS, anxiety, bipolar I disorder, RLS",,None,"['Body temperature increased', 'Dysstasia', 'Fall', 'Gait disturbance', 'Loss of personal independence in daily activities', 'Magnetic resonance imaging', 'Mobility decreased', 'Muscular weakness', 'Peroneal nerve palsy', 'Walking aid user']",UNK,MODERNA,IM 1069647,FL,73.0,M,"Beginning in the evening 2/19/21, fever/chills/fatigue; worsening of symptoms 2/20/21 with lethargy/lack of appetite/weakness; unable to arouse on 2/21/21 then breathing stopped, patient's spouse called 911 performed CPR, EMS continued for 15 min then while in ambulance to hospital where he was pronounced dead. Official time of death 2:20pm",Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/21/2021,2.0,OTH,"Furosemide, Midodrine, Amiodarone, Escitalopram, Aspirin, Finasteride, Tamsulosin, Rosuvastatin, Potassium Chloride, Oxycodone, Budesonide, Albuterol, Alprazolan",s/p CABG with valve replacement (1/28/21) with slow recovery (in ICU 2 weeks),"COPD, prostatitis, Celiac disease, arthritis, LBP",,NKA,"['Asthenia', 'Chills', 'Condition aggravated', 'Death', 'Decreased appetite', 'Depressed level of consciousness', 'Fatigue', 'Lethargy', 'Loss of consciousness', 'Pyrexia', 'Respiratory arrest', 'Resuscitation']",2,MODERNA,IM 1069685,MN,92.0,F,"3/2/21 became SOB, treated with oxygen and head of bed up in bed, only at dessert and drank supplement, for evening meal, no pain noted. 3/3/21 staff helped get her up in morning, went to weight room to take her weight, she then appeared to be struggling to breath, she was brough back to her room and the aides summoned nurse for assessment, was put back into bed, nurse noted poor color and shallow breathing, resident passed away shortly after that.",Yes,,Not Reported,Not Reported,,Not Reported,,03/02/2021,03/02/2021,0.0,SEN,"allopurinol, duloxetine, glipizide, melatonin, torsem",COVID 19,"heart failure, stage 4 KD, SOB, malnutrition, dysphagia, muscle weakness, unsteady, GERD, metabolic encephalopathy",,Morphine,"['Condition aggravated', 'Death', 'Dyspnoea', 'Hypopnoea', 'Pallor']",2,MODERNA,IM 1069743,OH,89.0,M,Cardiac arrest- death,Yes,02/27/2021,Not Reported,Not Reported,,Not Reported,N,02/25/2021,02/26/2021,1.0,PVT,,none reported,"A-fib, DM",,none,"['Cardiac arrest', 'Death']",2,PFIZER\BIONTECH,IM 1069755,IA,88.0,F,Patient completed vaccine series 2-18-2021. Was admitted to the hospital diagnosed with COVID-19 2-27-2021,Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/18/2021,02/27/2021,9.0,OTH,Aspirin 81 mg Calcium with Vitamin D Lisinopril 10mg Claritin 10 mg Metoprolol 50mg Omeprazole 20mg Artificial tears Ester-C,unknown,unknown,,"Codeine, Morphine","['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 1069771,NY,68.0,F,"Severe headache, extremely high blood pressure 220/120, low blood sugar, anxiety, insomnia",Not Reported,,Yes,Yes,1.0,Not Reported,N,02/17/2021,02/17/2021,0.0,OTH,"Multi vitamin, vitamin D",No,None,,"Penicillin, epinephrine","['Angiogram', 'Anxiety', 'Blood glucose decreased', 'Blood test', 'Chest X-ray', 'Electrocardiogram', 'Headache', 'Hypertension', 'Insomnia', 'Magnetic resonance imaging']",1,PFIZER\BIONTECH,SYR 1069774,DC,76.0,F,"shortness of breath, dyspnea on exertion that started after 2nd vaccine, found to have pulmonary embolism 2 weeks later",Not Reported,,Yes,Yes,2.0,Not Reported,Y,02/11/2012,02/13/2021,3290.0,PVT,"losartan, alendronate",,"HTN, osteoporosis, h/o DVT, SVT s/p ablation",,"sulfa, coumadin","['Angiogram', 'Dyspnoea', 'Dyspnoea exertional', 'Pulmonary embolism']",2,PFIZER\BIONTECH,IM 1069796,CA,89.0,M,Right dorsal medullary stroke leading to dysphagia and left-sided sensation changes. First noticed symptoms on 2/25 but did not present to emergency room until 2/27/2021. Patient was hospitalized 2/27/2021; anticipate discharge 3/4 or 3/5 2021. Patient lost ability to swallow; requires tube feeding.,Not Reported,,Not Reported,Yes,,Yes,N,02/24/2021,02/25/2021,1.0,PVT,None,None,"Type 2 diabetes, atherosclerosis of the aorta, MGUS",,None,"['Cerebrovascular accident', 'Dysphagia', 'Gastrointestinal tube insertion', 'Sensory disturbance']",1,PFIZER\BIONTECH,IM 1069806,OR,41.0,F,"Patient received her second covid 19 vaccine on the 18th of February - about four hours after she developed some soreness, fatigue and had a hard time moving her arm. Continued for a couple of days. Sunday 2/21 patient woke up without taste and her tongue was numb. That evening she began having some neck pain, below her ear, she massaged and didn't help all that well. At around 3 am that night, the pain was entirely on the right side of her neck and face, she took ibuprofen which mildly helped at night it was the entire neck. Monday 2/22 patient massaged area and it helped a little. She continued to have pain Tuesday 2/23 - Around 9am that morning patient noticed right sided facial drooping and her tongue was not working properly. She also noticed that her eye would not respond like her left eye. It was sluggish. When she went to brush her teeth, she noticed that the water would not stay in her mouth and it came out. At around 7pm that evening she went to the emergency room",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/18/2021,02/21/2021,3.0,PVT,None,"None, patient stated she's had ongoing headaches since her first COVID-19 vaccine in January",None,,No known allergies,"['Ageusia', 'Angiogram cerebral normal', 'Arteriogram carotid normal', 'Bacterial test negative', 'Bilirubin urine', 'Blood urine absent', 'Chest X-ray normal', 'Eyelid function disorder', 'Facial pain', 'Facial paralysis', 'Fatigue', 'Glucose urine absent', 'Hypoaesthesia oral', 'Magnetic resonance imaging head normal', 'Mobility decreased', 'Neck pain', 'Nitrite urine absent', 'Pain', 'Protein urine absent', 'Red blood cells urine negative', 'Scan with contrast normal', 'Specific gravity urine normal', 'Tongue movement disturbance', 'Urinary casts absent', 'Urinary sediment', 'Urine analysis', 'Urine ketone body absent', 'Urine leukocyte esterase', 'Urobilinogen urine', 'Vitamin C normal', 'White blood cells urine positive', 'pH urine normal']",2,PFIZER\BIONTECH,IM 1069814,FL,72.0,M,"Starting at 1100, (21 hours after vaccination) patient was brushing his teeth and noticed water was just drooling out of his mouth and when he looked in the mirror one side of his face didn't move, he thought he suffered a CVA",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/25/2021,02/26/2021,1.0,OTH,"Triamterene-HCTZ, MVI, Viagra, probiotic, gabapentin, potassium, methocarbamol, loratadine, olmesartan, carvedilol, terazosin, hydralazine, hydrocodone, valium, omeprazole, mesalamine, cipro",Prostatitis,"HTN, CHF, OSA, Vertebral disease, MVR, Elevated uric acid, bph, ulcerative colitis, testicular hypofunction",,"Amlodopine, percocet, amoxicillin","['Computerised tomogram', 'Facial paralysis', 'Magnetic resonance imaging']",UNK,MODERNA, 1069815,KS,69.0,M,"Almost immediately after vaccination patient started feeling poorly. Lightheaded, dizzy, ""just felt weird"". Able to drive home but continued to worsen, looking back should not have driven but was not thinking clearly. Feeling terrible once home, throwing up violently, Within an hour of injection started hallucenating, making strange uncontollable noises, ""lost touch with reality"", reports not being able to move. Wife called 911 and they arrived within 15-20 minutes. Wife reported to EMS that patient had just been vaccinated. EMS administered epinephrine and IV Benadryl. Transported patient to hospital",Not Reported,,Yes,Not Reported,,Not Reported,U,03/02/2021,03/02/2021,0.0,PUB,"blood pressure med Vitamin B12 Carbidopa Ambien Lorazepam, as needed Tramadol, as needed",Intestinal blockage,hypertension - treated with medication,,sulfa tetracycline erythromycin,"['Abnormal behaviour', 'Computerised tomogram', 'Dizziness', 'Feeling abnormal', 'Hallucination', 'Magnetic resonance imaging', 'Mental disorder', 'Mobility decreased', 'Vomiting']",1,PFIZER\BIONTECH,IM 1069829,NM,73.0,M,"Clients spouse, called to report adverse event. She reported that Medical Center directed her to call and make a report. Her spouse experienced a stoke 3 days following booster vaccination. Is currently hospitalized at Medical Center.",Not Reported,,Yes,Yes,4.0,Not Reported,N,02/24/2021,02/27/2021,3.0,OTH,losartan ashwagandha turmeric multi vitamin,none,"h/o left hip pain related to past trauma from auto and motorcycle accidents hypertension hep c for decades, completed full hep c treatment 9/2020 -12/2020 and tested hcv negative following therapy h/o kidney stone with surgically removed 2015 h/o hep b infection overweight not obese",,no known allergies,['Cerebrovascular accident'],2,PFIZER\BIONTECH,IM 1069830,MO,87.0,F,"From CT Scan in ED at 7:40 pm on 1/25/2021 -- There is a large intraparenchymal hemorrhage with Surrounding vasogenic edema within the left occipital lobe. There is additional subdural hemorrhage layering along the left frontal, temporal and parietal convexity which may be decompressing from the area of intraparenchymal hematoma. No visualized intraventricular hemorrhage.There is some trace hemorrhage layering along the left tentorium cerebelli. Severe associated mass effect with left-to-right midline shift of 2.1 cm. There is subfalcine and downward transtentorial herniation with complete effacement of the basilar cisterns. Evaluation of the craniocervical junction is limited due to beam hardening artifact. Near-complete effacement of the left lateral ventricle. No head trauma or fall. Deceased 1/26/2021",Yes,01/26/2021,Not Reported,Yes,1.0,Not Reported,N,01/08/2021,01/25/2021,17.0,SEN,aspirin 81 mg daily; Tylenol arthritis 650 mg daily; calcium and vit d; meclizine 12.5 mg daily; Fosamax 70 mg every 7 days; Toprol 50 mg ext release daily; cozaar 50 mg daily; levothyroxine 100 mcg daily; crestor 10 mg MWF; plaquenil 400,,"arthritis, osteoporosis, prior heart stent",,NSAIDS,"['Basophil count normal', 'Basophil percentage', 'Brain herniation', 'Cerebral haemorrhage', 'Cerebral mass effect', 'Computerised tomogram head abnormal', 'Death', 'Encephalitis', 'Eosinophil count increased', 'Eosinophil percentage', 'Granulocyte count', 'Granulocyte percentage', 'Haematocrit decreased', 'Haemoglobin decreased', 'Imaging procedure artifact', 'Lymphocyte count', 'Lymphocyte count decreased', 'Lymphocyte percentage decreased', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Mean platelet volume normal', 'Meningioma', 'Monocyte count increased', 'Monocyte percentage abnormal', 'Neutrophil count increased', 'Neutrophil percentage', 'Platelet count normal', 'Red blood cell count decreased', 'Red cell distribution width normal', 'Subdural haemorrhage', 'Vasogenic cerebral oedema', 'White blood cell count increased']",1,MODERNA,IM 1069835,CA,44.0,F,Several (>4) hours after vaccination patient started feeling fevers and severe body aches - presented to ER where she was found to be borderline hypotensive (systolic BP 80s v. baseline low 100s) - received IV fluids with resolution. Observed inpatient for 24 hours.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/10/2021,02/10/2021,0.0,UNK,"cetirizine, nasal fluticasone",none,unspecified allergic rhinitis,,unspecified allergic rhinitis,"['Hypotension', 'Laboratory test normal', 'Pain', 'Pyrexia']",UNK,MODERNA, 1069876,OR,73.0,M,"Vaccinated 2/20. At that time, had symptoms of incarcerated hernia, went to ED for evaluation. Not felt to warrant hospital admission. Returned two days later with agitation, altered mental status, and incarceration. Went to OR, uncomplicated hernia repair. Postoperatively, did not recover mental status. Went into arrythmias POD 4, hypotension ensued, had multiple interventions and evaluations without satisfying answers for clinical course.",Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/22/2021,2.0,PVT,"Albuterol , Budesonide, Clotrimazole, Levothyroxine, Lorazepam, Methadone, Nicotine 2mg gum , Polyethylene glycol, Potassium chloride, Sennosides, Tamsulosin, Tiotropium, Torsemide",Incarcerated ventral/incisional hernia,"CAD, Hep C wiht cirrhosis, CKD, CHF, COPD, HTN, chronic pain, hypothyroidism",,NKDA,"['Agitation', 'Arrhythmia', 'Death', 'Hernia repair', 'Hypotension', 'Incarcerated hernia', 'Mental status changes', 'Sinus arrhythmia']",2,PFIZER\BIONTECH,IM 1069891,IA,58.0,F,"High temp, ache all over, severe headache,, head to toe all over body edema, systemic body rash and itching. Took Benadryl and caused elevated b/p. Went to ER and had steroids.",Not Reported,,Yes,Not Reported,,Not Reported,U,02/20/2021,02/20/2021,0.0,SEN,,may have been at the end of mild case of COVID,no,,no,"['Blood pressure increased', 'Generalised oedema', 'Headache', 'Laboratory test', 'Pain', 'Pruritus', 'Pyrexia', 'Rash']",2,PFIZER\BIONTECH,IM 1069893,CO,72.0,M,"Transported to Emergency by ambulance. Ran blood work, MRI, CAT, hard ECHO, administered antibotics and ran extensive testing to identify potential sources that could cause illness after vaccination.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,02/25/2021,02/26/2021,1.0,PVT,Lisinopril-HCTZ 20-12.5 MG TAB,None,None,,None,"['Blood test', 'Computerised tomogram', 'Echocardiogram', 'Illness', 'Magnetic resonance imaging']",2,PFIZER\BIONTECH,IM 1069924,CA,66.0,M,"On 02/12/2021 around 11:00am I was assigned to have Covid 19 shot at the table#6. At that time I saw the Vaccine was already in the syringe which was in the plastic bag with zipper. Ten days after the shot I felt well, no pain nor swell on my left shoulder. But in the morning of 02/23/2021 after waking up I started to feel hurt to my left arm and the pain was transmitted to the left of my back (left lung). During these 3 days 23,24,25 my pain reached the maximum intensity 10/10 even I took 3 times a day Ibuprofen which was each time 2x200mg. On 02/26/2021 I went to Hospital in the Emergency Unit and after diagnosis the Doctors found that I had 3 heart arteries clog-up. How can I be sure that the liquid in the syringe is the Pfizer Vaccine or something else? I used to see the TVs broadcast on the Covid 19 shot that the nurse inserts the syringe in the small Pzifer bottle, suck the Vaccine into syringe and inject the vaccine into the shoulder of the patient. Can CDC require that all Covid 19 providers show the vaccine to all patients before the shot? In 2017 I had an Angiogram and my 3 bypasses were not clogged why they are all clogged now? I don't change my every day diet and I'm very careful with eating fat, cholesterol and salt in my everyday food.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/12/2021,02/23/2021,11.0,PUB,None,No,"Shoulders, back and knees pain come on or off when working. More time to work, more pain; less time to work less pain.",,No,"['Back pain', 'Coronary artery occlusion', 'Injection site pain', 'Pain in extremity']",1,PFIZER\BIONTECH,IM 1069931,NY,65.0,F,"on 2/4/21, patient developed refractory seizures, requiring hospitalization and antiepileptic medications among others. She had no history of seizures, as well as negative LP studies and negative CNS imaging.",Not Reported,,Yes,Yes,5.0,Not Reported,Y,01/01/2021,02/04/2021,34.0,UNK,"femara, metformin, losartan-hctz, metoprolol","breast cancer, diabetes, rheumatoid arthritis","breast cancer, diabetes, rheumatoid arthritis",,penicillin,"['CSF test normal', 'Computerised tomogram head normal', 'Magnetic resonance imaging head normal', 'Seizure']",2,PFIZER\BIONTECH,IM 1069938,IA,80.0,F,expired at Hospital,Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/20/2021,16.0,PUB,unknown blood thinner,"unknown, none listed on pre checklist","unknown, takes blood thinner",,nkma,['Death'],1,MODERNA,IM 1069978,MD,71.0,M,"Patient has a debilitating headache on the Friday, Saturday, and Sunday after the second dose. He still had the headache but not as bad on Monday, Tuesday, and Wednesday after the second dose. On Wednesday morning, he passed out three times while in the shower and bathroom. He has been admitted to the hospital. They have ruled out a heart attack and most likely ruled out a stroke. He is still undergoing tests.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/25/2021,02/25/2021,0.0,PHM,Atorvadstatin Calcium Cilostazol Potassium Baby aspirin,None,Arteries in ankles,,None,"['Blood pressure decreased', 'Blood test', 'Electrocardiogram', 'Headache', 'Loss of consciousness', 'Magnetic resonance imaging']",UNK,MODERNA, 1069988,TX,40.0,F,My regular menses have completely disappeared when I had previously been regular and my hormone levels went from normal to menopausal levels. I had my levels taken only a month before getting the first vaccine. I was fine after first dose and got very sick after the second dose and since that time have not had a menstrual cycle or ovulated.,Not Reported,,Not Reported,Not Reported,,Yes,N,01/28/2021,01/29/2021,1.0,PHM,"CoQ10, multi-vitamin, Adderall",None,None,,,"['Amenorrhoea', 'Blood follicle stimulating hormone increased', 'Blood luteinising hormone increased', 'Blood oestrogen decreased', 'Malaise', 'Menstrual disorder', 'Ovulation delayed', 'Progesterone decreased']",2,MODERNA, 1070005,TX,85.0,M,Patient contracted Covid some period of time after receiving the vaccine.,Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,,,PVT,,"Hypertension, CAD, Hypothyroidism, Hypercholesterolemia","Hypertension, CAD, Hypothyroidism, Hypercholesterolemia",,NKA,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1070038,HI,68.0,M,Client passed away 8 days after being vaccinated. It is unknown if it occurred from the vaccine or other comorbidities.,Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/22/2021,8.0,PUB,Plavix Aspirin Lisinopril Diazepam Morphine Sulfate Lyrica Spiriva Respinate Proair Air,COPD,COPD Vascular Disease Chronic Pain Opioid Dependence HTN,,No known allergies,['Death'],1,MODERNA,IM 1070039,OH,86.0,F,Patient with 3-7 days of weakness. Hospitalized 2/16-2/20 for fever weakness and SOB. Diagnosed with COVID-19 and UTI. Did require O2 per NC briefly. Was treated with IV/PO dexamethasone and IV/PO Cipro Discharged to home,Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/22/2021,02/09/2021,18.0,PVT,Elavil 50mg QHS Eliquis 2.5mg BID Biotin Refresh eye gtts Plavix 75mg QD Restasis eye gtts Flonase NS 2sprays each nares QHS glimepiride 2mg QD glucosamine-chondroitin TID levothyroxine 75mg daily loratadine 10mg QD metoprolol 50mg BID mon,,CKD stage 3-4 GERD Type 2 DM hypothyroidism drug induced interstitial lung disorder paroxysmal AF HTN OA insomnia chronic pain,,Levofloxacin PCN SMX-TMZ NSAIDs Erythromycin,"['Asthenia', 'Blood bicarbonate normal', 'Blood chloride decreased', 'Blood creatinine increased', 'Blood glucose increased', 'Blood potassium decreased', 'Blood sodium decreased', 'Blood urea increased', 'Brain natriuretic peptide increased', 'COVID-19', 'Dyspnoea', 'Haematocrit decreased', 'Haemoglobin decreased', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Platelet count decreased', 'Pyrexia', 'Red blood cells urine positive', 'SARS-CoV-2 test negative', 'Troponin increased', 'Urinary tract infection', 'Urine leukocyte esterase positive', 'White blood cell count increased', 'White blood cells urine positive']",1,PFIZER\BIONTECH,IM 1070040,MD,71.0,F,Admitted to hospital 2/22/21,Yes,02/24/2021,Not Reported,Yes,2.0,Not Reported,,02/10/2021,02/22/2021,12.0,OTH,"Duloxetine, LIsinopril/Hctz, Oxycodone 10/325, Gabapentine 600",Thyroid nodule,"Diabetes, HTN, Depression, chronic pain",,Morphine,['Death'],1,UNKNOWN MANUFACTURER, 1070051,TX,79.0,F,unknown,Yes,01/15/2021,Yes,Not Reported,,Not Reported,N,01/06/2021,,,PVT,"Gabapentin, Pennsaid, Carbidopa-Levodopa","HTN, Aortic Valve Disorder, Coronary Atherosclerosis of Native Coronary Artery, Hyperlipidemia, Aortic aneurysm","HTN, Aortic Valve Disorder, Coronary Atherosclerosis of Native Coronary Artery, Hyperlipidemia, Aortic aneurysm",,Unknown,['Death'],1,MODERNA,IM 1070055,OH,66.0,F,"Severe headache 10/10, nausea, vomiting, temp of 99 degrees F x 24 hours. waning at this time",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/02/2021,03/02/2021,0.0,PHM,,,,,,"['Headache', 'Nausea', 'Vomiting']",1,JANSSEN,IM 1070488,WI,71.0,F,"Bell's Palsy; A spontaneous report was received from a Consumer regarding his wife who received the first dose of Moderna Covid-19 vaccine and have experienced Bell's palsy. The patient's medical history was not provided. Her concomitant medication is thyroxine. No information on allergies. On 04-FEB-2021, prior to the onset of events, the patient received first of two planned doses of Covid-19 vaccine intramuscularly for the prophylaxis of Covid-19 infection. On 11-FEB-2021, patient noticed excessive watering from her right eye, next day on 12-FEB-2021, she felt jaw pain on right side of her mouth and her lip began to droop. On13-FEB-2021, patient was taken to ER where she was diagnosed with Bell's Palsy. She was treated with antivirals and steroids. She is recovering, but still side effects are present. Action taken with the 2nd dose of vaccine was not reported. The outcome of the event Bell's Palsy is still recovering at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/13/2021,9.0,UNK,THYROXINE,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"[""Bell's palsy""]",1,MODERNA,OT 1070489,TX,,F,"UTI infection; swollen lymph nodes,hard to touch; swollen at site of injection; Headache; Fatigue; Tenderness at site of injection; A spontaneous report was received from a consumer concerning a 54 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lymph nodes near neck are swollen and hard to touch, tenderness at site of injection, swollen at site of injection, Urinary tract infections, tiredness and headache. The patient's medical history was not provided. Relevant concomitant medications were reported ""hidden"". On 04-FEB-2021 approximately a week prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number012M2 (or 7) 0A) in left arm for prophylaxis of COVID-19 infection. On 11-FEB-2021 or 12-FEB-2021, the patient started feeling something on the left area near the neck lymph nodes swollen and hard to touch and headache. On that weekend patient experienced tenderness and swollen at injection site and tiredness. Treatment for the event included two paracetamol for pain and OTC ""Quora"" for Urinary tract infections on 17-FEB-2021. The outcome of the events, lymph nodes near neck are swollen and hard to touch, tenderness at site of injection, swollen at site of injection, Urinary tract infections, tiredness and headache, were unknown.; Reporter's Comments: Based on the information provided which includes a temporal association, and known safety profile of the vaccine, a causal association between the reported events of lymphadenopathy, injection site tenderness and swelling, tiredness and headache and the administration of the mRNA-1273 vaccine cannot be excluded. Urinary tract infections is assessed as unlikely related to vaccine use but due to an infection",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/17/2021,13.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Fatigue', 'Headache', 'Lymphadenopathy', 'Urinary tract infection', 'Vaccination site pain', 'Vaccination site swelling']",1,MODERNA,OT 1070490,NJ,89.0,F,"Did not open eyes (Unresponsive); Not speaking; Fever; Positive COVID Test; UTI; A spontaneous report was received from a consumer concerning an 89-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: did not open eyes (unresponsive)/unresponsive to stimuli, UTI (urinary tract infection), positive COVID test/SARS-CoV-2 test postive, fever (pyrexia) and not speaking (dysphasia). The patient's medical history included Parkinson's Disease. On 19-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) intramuscularly for prophylaxis of COVID-19 infection. Treatment included antibiotics, remdesivir IV (intravenous) and rehabilitation. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events did not open eyes (unresponsive), UTI, positive COVID test, fever, and not speaking was unknown.; Reporter's Comments: This case concerns an 89-year-old female who experienced serious unexpected events of COVID-19, pyrexia, urinary tract infection, aphasia, unresponsive to stimuli. The events occurred 25 days after the first dose of mRNA-1273. Treated with antibiotics and IV remdesivir. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/07/2021,01/31/2021,24.0,UNK,,Parkinson's disease,,,,"['Aphasia', 'Pyrexia', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive', 'Unresponsive to stimuli', 'Urinary tract infection']",1,MODERNA,OT 1070491,TX,,F,"difficulty breathing; vision issues; cloudy and fogginess; vomiting; While in the hospital she was stated to have been on 100% oxygen, couldn't breathe at all; A spontaneous report was received from a 50-year-old female patient. The patient's medical history included Lupus, and COPD. Products known to have been used by the patient, within two weeks prior to the event, included Salbutamol Sulfate, Alprazolam, Lisinopril, Ezetimibe, and Pantoprazole Sodium Sesquihydrate. On 31 Dec-2020, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Lot unknown) by injection (site not provided) for prophylaxis of COVID-19 infection. On 31-Dec-2020, the patient developed difficulty breathing, vision became cloudy/foggy and vomiting. The patient spent New Year's day in the hospital (admission and discharge date and times were not provided), she was treated with 100% Oxygen, Zofran and Morphine. The patient also had nine symptoms while she was in the hospital however details were not reported. Action taken with mRNA-1273 in response to the events was unknown The outcome of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,12/31/2020,12/31/2020,0.0,UNK,INHALERIN; XANAX; LISINOPRIL; ZETIA; PROTERA [PANTOPRAZOLE SODIUM SESQUIHYDRATE],COPD; Lupus pneumonitis,,,,"['Dyspnoea', 'Vision blurred', 'Vomiting']",1,MODERNA,OT 1070495,SC,,F,"Severe digestive issues; Nausea; Vomiting; Diarrhea; Upper back pain; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's son explained he has gotten a call from his mother who was 77 years old and received her first vaccine this past Thursday at a Hospital. She was now experiencing vomiting, diarrhea, and upper back pain. He wasn't sure if him and his brother should take her to the emergency room because of her age and her condition. He was not sure if this was a reaction to the vaccine since the vaccine was given so many days ago. He explained he and his mother had the vaccine basically at the same time and he has had no reactions. However, his mother was experiencing digestive issues and lots of diarrhea, vomiting, and nausea. He was trying to determine the best course of action and determine if she should go to the emergency room based on her age and condition. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Back pain', 'Diarrhoea', 'Gastrointestinal disorder', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH, 1070497,MI,,M,"real bad back problems, back pain; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable consumer (patient's wife) reported that a 77-year-old male patient (husband) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot and expiry not reported), via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunisation. Medical history included back issues (on and off). The patient's concomitant medications were not reported. It was reported that both consumer (wife) and patient (husband) received the first dose of Pfizer COVID19 vaccine on 23Jan2021. The wife reported that the patient been having real bad back problems, back pain that started 2-3 day afterwards (in Jan2021) and asked if that was one the side effect of the covid-19 vaccine. It comes and goes and was currently ongoing. The event was considered by the wife as non-serious. The patient did have a history of back issues on and off and they planned to discuss this further with his back doctor. Second dose was currently scheduled for 14Feb2021. The wife asked that due to back pain if the patient should get the second dose and/or could it be rescheduled. The outcome of the event was not recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Back disorder (on and off),,,['Back pain'],1,PFIZER\BIONTECH, 1070499,,,M,"he started experiencing vertigo which lasted 5 or 6 days; only experiencing dizziness when he tries to stand; This is a spontaneous report from a contactable consumer (wife). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated that her husband (patient) received the first dose of the Pfizer COVID-19 vaccine and about 4 days later (date unspecified) he started experiencing vertigo which lasted 5 or 6 days. Patient was now (since an unknown date) only experiencing dizziness when he tries to stand. Patient did speak with his primary care provider to let her know about this reaction after receiving the first dose of the Pfizer COVID-19 vaccine and she prescribed meclizine as a treatment for his vertigo and dizziness. The reporter would like to know if her husband should receive the second dose considering his reaction after the first dose. The reporter would like to know if the two doses of the Pfizer COVID-19 vaccine are the same and would like to know how effective the Pfizer COVID-19 vaccine is after the first dose. The events were reported as non-serious. Therapeutic measures were received in response to the reported events. The outcome of the events vertigo and dizziness was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Dizziness postural', 'Vertigo']",1,PFIZER\BIONTECH, 1070505,,,F,"she hurt all over; had no appetite; chills; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 13Jan2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 16Jan2021 (3.5 days later), the patient was hurt all over, she had no appetite and had chills. The patient did not have fever. The patient reported she is due to have her second dose on 03Feb2021 and she asked whether or not she should receive the second dose. She stated she heard the second dose was worse in regard to adverse reactions than the first dose and was wondering if this is true. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/16/2021,3.0,UNK,,,,,,"['Chills', 'Decreased appetite', 'Pain']",1,PFIZER\BIONTECH, 1070514,,,F,"she had a sore arm; This is a spontaneous report from a Pfizer-sponsored program,. A contactable consumer (patient) reported that an 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer COVID vaccine and she felt fine but then stated that she had a sore arm. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain in extremity'],UNK,PFIZER\BIONTECH, 1070520,FL,,M,"His arm was a little sore, but not bad; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 01Feb2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included ongoing acetylsalicylic acid (ASPIRIN) as blood thinner and unspecified medications. The patient got his first shot of COVID vaccine on an unspecified date and is going to get the second shot 18Feb2021. He took acetylsalicylic acid 4 hours before the first shot. He was wondering if he should acetylsalicylic acid before or after the shot. He had no reaction from taking acetylsalicylic acid. He was on 81 mg, one a day of acetylsalicylic acid as a blood thinner. He didn't think it was a problem. He has read the things about paracetamol (TYLENOL), but he doesn't take that. The patient was just curious because he has been reading up on the COVID vaccine. It said to wait to take paracetamol. He was glad he got the vaccine from Pfizer. His arm was a little sore on an unspecified date, but not bad. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,ASPIRIN [ACETYLSALICYLIC ACID],,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1070521,TN,52.0,M,Under arm knot as big as a baseball,Not Reported,,Not Reported,Not Reported,,Yes,N,02/28/2021,03/01/2021,1.0,PVT,None,None,None,,Ibuprofen,"['Nodule', 'Ultrasound scan']",1,PFIZER\BIONTECH, 1070524,CA,59.0,F,"Rash in middle of back then neck, shoulders, legs and forehead. Went to the ER, and was some medicine, Zyrtec and EpiPen.",Not Reported,,Not Reported,Yes,,Not Reported,N,03/02/2021,03/02/2021,0.0,OTH,Prilosec,no,no,,Amoxicillin,['Rash'],1,MODERNA,IM 1070534,CA,,F,"Dizziness; This is a spontaneous report from a contactable consumer reporting for herself. An 84-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021, at single dose, for COVID-19 immunisation. Medical history included sinus disorder. Concomitant medications were not reported. The patient experienced dizziness in Feb2021, 3-4 days after vaccination. on an unspecified date with outcome of recovering. The patient did not know if the dizziness was due to the COVID-19 vaccine or her sinus disorder. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/24/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Sinus disorder,,,['Dizziness'],1,PFIZER\BIONTECH, 1070546,NE,26.0,M,"Immediate burning in both arms. Unable to hold a pencil to fill out card after receiving vaccine. Weakness in upper extremities. Tingling, pain and numbness in both arms, red streaks appeared on the left arm going further up on to the shoulder, the were visible and painful for about 90 mins. Sweating. Nausea. Blurred vision. Loss of consciousness. Headache behind the eyes.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/03/2021,03/03/2021,0.0,WRK,Vitamin D3 gummies 200mcg PO QD,None,None,,NKDA,"['Burning sensation', 'Erythema', 'Eye pain', 'Grip strength decreased', 'Hyperhidrosis', 'Hypoaesthesia', 'Immediate post-injection reaction', 'Injection site pain', 'Injection site streaking', 'Loss of consciousness', 'Muscular weakness', 'Nausea', 'Pain in extremity', 'Paraesthesia', 'Vision blurred']",1,JANSSEN,IM 1070562,CA,77.0,M,The coroner called Dr. on 3.2.2021 to advise that he had a witnessed collapse and Mr. was taken to the ED where he was pronounced.,Yes,03/02/2021,Not Reported,Not Reported,,Not Reported,N,03/01/2021,03/02/2021,1.0,OTH,,,"Relatively severe aortic valve stenosis, bradycardia, orthostatic hypotension and Parkinson's disease",,,"['Death', 'Syncope']",2,MODERNA,IM 1070572,OR,28.0,F,"Nauseousness; fatigue; diarrhea; This is a spontaneous report from a contactable consumer reported for herself. A 28-year-old female patient (non-pregnant) received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number and expiry date were unknown), via an unspecified route of administration on the right arm on 31Jan2021 17:30 at a single dose for COVID-19 immunization. The patient has no other medical history. The patient has no known allergies to medications, food, or other products. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Feb2021 at 08:00, the patient experienced nauseousness, fatigue, and diarrhea. No treatment was received for the reported adverse events. The outcome of the events was unknown. The case has been considered non-serious. Information on the lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/31/2021,02/01/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Diarrhoea', 'Fatigue', 'Nausea']",1,PFIZER\BIONTECH, 1070573,CA,41.0,F,"Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. onset within 30 minutes of vaccines. taken to Urgent care, received epinephrine injection, then transferred by ambulance to Hospital ER. given IV diphenhydramine and IV decadron. chest pain. normal ECG and troponin. They did not check tryptase.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,OTH,none,none,none,,none,"['Cardiovascular evaluation', 'Chest pain', 'Dysphagia', 'Electrocardiogram normal', 'Palpitations', 'Speech disorder', 'Swollen tongue', 'Throat tightness', 'Troponin normal']",1,PFIZER\BIONTECH,IM 1070582,GA,69.0,M,"positive COVID-19 test; Arm was a bit sore; This is a spontaneous report from a contactable consumer (patient's wife) received from a Pfizer sponsored program. A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at arm left on 19Jan2021 (at the age of 69 years) at single dose for COVID-19 immunisation. Medical history included heart stent and blood pressure abnormal, both from an unknown date and unknown if ongoing. Concomitant medication included omeprazole (PROTONIX). The patient experienced COVID-19 test that was positive on 23Jan2021 and arm was a bit sore on Jan2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 23Jan2021. Therapeutic measures were taken as a result of COVID-19 and included treatment with infusion of the monoclonal antibodies (Eli Lilly) on 27Jan2021. The patients outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,01/01/2021,,UNK,PROTONIX [OMEPRAZOLE],,Medical History/Concurrent Conditions: Blood pressure abnormal; Coronary stent user,,,"['COVID-19', 'Pain in extremity', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1070583,KS,66.0,M,"He complained of dizziness the evening of the shot. He went to bed and when he woke up the next morning he was having double vision. Is eye drifted off to the side and he was too dizzy to get up. He was taken to the hospital. They did a CT scan which didn't give a diagnosis, and they were unable to do a MRI scan due to a medical reason, so they could not determine for sure if he had a stroke. They are assuming that he did have a stroke and he has oculomotor nerve paralysis on the right side. The nurse practitioner saw him today and she reports he is doing very well now. He had been staying in a assisted living type facility when this occurred, but he is expected to return home tomorrow.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PUB,,,,,,"['Cerebrovascular accident', 'Computerised tomogram', 'Diplopia', 'Dizziness', 'Eye movement disorder', 'IIIrd nerve paralysis']",2,MODERNA,IM 1070595,LA,68.0,F,"acute ITP, platelet count 2,000 with petechial rash, bruising, fatigue, herpes labialis simplex one - petechia occurred 7 days post vaccine; hospitalization 9 days post vaccine. responded to steroids and normalized platelet count 180,000 14 days post vaccine",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/17/2021,02/24/2021,7.0,PVT,amlodipine Breo ellipta,,� ? Hypertension � ? Mild asthma ? Osteoarthritis of multiple joints,,"Glyceryl-t, Nickel, Pcn [Penicillins]","['Antinuclear antibody', 'Blood thyroid stimulating hormone', 'Complement factor normal', 'Contusion', 'Differential white blood cell count normal', 'Electrophoresis protein normal', 'Fatigue', 'HIV test negative', 'Haematocrit normal', 'Haemoglobin normal', 'Helicobacter test negative', 'Hepatitis B test negative', 'Hepatitis C test negative', 'Immune thrombocytopenia', 'Immunoglobulins normal', 'Oral herpes', 'Petechiae', 'Platelet count decreased', 'Respiratory viral panel', 'Rheumatoid factor', 'SARS-CoV-2 test negative', 'Vitamin B12 normal', 'White blood cell count normal']",1,MODERNA,IM 1070611,AK,50.0,M,"Excessive tiredness; Body aches; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL34264-21) in the right arm, at single dose, on 25Jan2021, at 06:00 PM, for COVID-19 immunisation. COVID-19 vaccine was administered at Hospital. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Relevant medical history was unknown. Allergies to medications, food, or other products was reported as none. Concomitant medications included loratadine (CLARITIN) and paracetamol (TYLENOL), both from an unspecified date (within 2 weeks of vaccination), for an unknown indication. On 26Jan2021, the patient experienced excessive tiredness, and body aches. No treatment was received. Clinical outcome of the events was recovering at time of this report. Post the vaccination, the patient has not been tested for COVID-19. The case was assessed as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,PVT,CLARITIN [LORATADINE]; TYLENOL,,,,,"['Fatigue', 'Pain']",1,PFIZER\BIONTECH, 1070629,VA,51.0,F,"51 y/o female, no chronic health problems. 14 days following first COVID Pfizer vaccine, I felt unable to take a deep breath, on day 15 following the vaccine, I became short of breath,; on day 16 I was having mild chest pain with inspiration and shortness of breath; day 17 following vaccination I became significantly short of breath, with moderate to severe chest pain with inspiration and tachycardia (heart rate in the 140's). I called my PCP who ordered an EKG, CXR, COVID swab, a metabolic panel, a CBC, and a D-dimer. My D-dimer was elevated and he called me to go directly to the emergency department, which I did and had a CTA chest. I was diagnosed with multifocal pulmonary emboli in my right lung with a slight pleural effusion on my left lung. I had a duplex ultrasound of my legs which was negatve for DVT, and an echocardiogram which was within normal limits. I was finally diagnosed with acute unprovoked pulmonary embolism, given a Heparin bolus and started on a Heparin IV infusion. Ultimately, I transitioned to Eliquis PO and was discharged from the hospital within 24 hours.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,12/27/2020,01/10/2021,14.0,PVT,Zoloft 100mg PO daily; Protonix 20mg PO daily,none,none,,penicillin,"['Activated partial thromboplastin time', 'Angiogram pulmonary abnormal', 'Chest X-ray', 'Chest pain', 'Dyspnoea', 'Echocardiogram normal', 'Electrocardiogram', 'Fibrin D dimer increased', 'Full blood count', 'International normalised ratio', 'Metabolic function test', 'N-terminal prohormone brain natriuretic peptide', 'Painful respiration', 'Pleural effusion', 'Prothrombin time', 'Pulmonary embolism', 'SARS-CoV-2 test', 'Tachycardia', 'Troponin', 'Ultrasound Doppler', 'Ultrasound Doppler normal']",1,PFIZER\BIONTECH,IM 1070645,NY,69.0,M,"weakness, dehydration, blurred vision, myalgias",Not Reported,,Not Reported,Yes,,Not Reported,U,03/02/2021,03/02/2021,0.0,UNK,"Medrol, gengraft, celcept, protonix, Lipitor, Bactrim enalapril, gabapentin, aspirin, timolol, calcium, travaprost",,"kidney transplant, afib, htn, hld",,,"['Acute kidney injury', 'Asthenia', 'Dehydration', 'Myalgia', 'Vision blurred']",1,MODERNA, 1070659,LA,,M,"positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; stomach issue; This is a spontaneous report from a contactable consumer (patient). A male patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced stomach issues on an unknown date. He was scheduled for an scope on the esophagus and had a COVID test ""on Sunday"" which came back with a positive result. The patient has no symptoms and had a 96.5 temperature. He was scheduled for his second dose ""today"". The clinical outcome of the event positive COVID-19 test with no symptoms and abdominal discomfort was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Abdominal discomfort', 'Body temperature', 'COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1070660,CA,,F,"tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program Pfizer First Connect. A female patient of an unspecified age receive their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that after the first dose, the patient tested positive for covid on an unspecified date in Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jan2021. The outcome of the events was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1070661,OH,57.0,F,"seems to have an autoimmune response; She has hives wrapped around her entire left ankle; Other medical history: Graves disease; Other medical history: Graves disease; this is her ankle is swollen and not very comfortable; this is her ankle is swollen and not very comfortable; This is a spontaneous report from a contactable other health professional (patient). A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, pending clarification), via an unspecified route of administration (at the age of 57-year-old) on 12Jan2021 (also reported as 19Jan2021, pending clarification) at a single dose for COVID-19 immunization. Medical history included Graves disease and COVID-19. Concomitant medication included metoprolol. Patient completed the report online at Pfizer, but does not have a reference number for that report. She is scheduled to get second shot tomorrow, however, she seems to have an autoimmune response. She has hives wrapped around her entire left ankle on 22Jan2021. She wants to know if she should get second dose or not. She works in a nursing home. She has been noticing here and there little dots of hives that were not a big deal and this is her ankle is swollen and not very comfortable. The patient would like to know if it would be safe for her to have the second dose given her autoimmune response to the first dose. No treatment received for the event ""She has hives wrapped around her entire left ankle"". The outcome of the events was unknown. The patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. Not COVID tested post vaccination. Information on the lot/batch number has been requested (clarification).",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/12/2021,0.0,SEN,METOPROLOL,,Medical History/Concurrent Conditions: COVID-19; Graves' disease,,,"['Immune system disorder', 'Joint swelling', 'Musculoskeletal discomfort', 'Off label use', 'Product use issue', 'Urticaria']",1,PFIZER\BIONTECH, 1070662,MS,,F,"nausea; vomiting; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nausea and vomiting on an unspecified date after receiving the first vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Nausea', 'Vomiting']",1,PFIZER\BIONTECH, 1070663,NC,,F,"Pain; This is a spontaneous report from a Pfizer-sponsored program, . A contactable consumer (patient) reported that a female patient of unspecified age received first dose of BNT162B2 (Pfizer Covid-19 vaccine), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient asked if it is ok to take pain medicine (ibuprofen) while she already had the 1st dose. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain'],1,PFIZER\BIONTECH, 1070669,NY,49.0,F,"tested positive, she had no symptoms for COVID; tested positive, she had no symptoms for COVID; This is a spontaneous report from a contactable nurse, reporting for herself. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246, expiry date: 30Apr2021), via an unspecified route of administration at the left deltoid on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient tested positive, she had no symptoms for COVID on 22Jan2021. The patient got the first dose of the COVID vaccine on 06Jan2021, and tested positive, she had no symptoms for COVID, but tested positive on 22Jan2021. She tested negative on 24Jan2021and again 28Jan2021, both negative. And she was due on 27Jan2021 for the next dose, but was told she had to wait 10 days, then 3 months, she doesn't know what to do, which was why was she calling. She wants the second vaccine, she was just not sure what the answer was. She didn't feel sick, she was ok, it was serious that she tested positive, yes, but she was ok. She added there were two doses in the vial, and she watched the nurse drew hers up. Added she was asymptomatic. The patient was tested due to presurgical testing, she was supposed to get her gallbladder out, and surgery needed to be canceled. She was asking if after testing positive, can she get the second dose and when can she get it. The outcome of the events was unknown.; Sender's Comments: The contributory role of the suspect product to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/22/2021,16.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1070670,MI,84.0,F,"slept for 1 1/2 days directly after the shot; slept the whole day; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140 and expiry date: unknown), intramuscular on the left arm, on 07Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. When she had the first dose she slept for 1 1/2 days directly after the shot on 07Jan2021. She got the shot in the morning and she slept until 10, so she was not really sure how long she slept. The next day she slept the whole day too. She had no pain and is better. Outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/07/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Hypersomnia'],1,PFIZER\BIONTECH,OT 1070676,CA,66.0,F,"my tongue and inside mouth started tingling; Inside mouth must have swelled, as I have bit the right side of the inside of my mouth; I also notice that my bottom lip feels puffy; This is a spontaneous report from a contactable consumer reported for herself. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EN6201), via an unspecified route of administration on 15Feb2021 10:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Patient was not pregnant at the time of vaccination. Medical history included allergy to Sulfa based meds, Penicillin. Concomitant medication included estradiol, bupropion, fluoxetine, levothyroxine. The patient previously took dilaudid and experienced drug allergy, alendronate and experienced drug allergy, risedronate and experienced drug allergy. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 15 minutes of injection, patient's tongue and inside mouth started tingling. Inside mouth must have swelled, as she had bit the right side of the inside of mouth. She also noticed that her bottom lip felt puffy. The event onset date was reported as 15Feb2021 10:45 AM. Patient received treatment for the adverse event included Benadryl. The outcome of event was recovering. The case was reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/15/2021,0.0,UNK,ESTRADIOL; BUPROPION; FLUOXETINE; LEVOTHYROXINE,,Medical History/Concurrent Conditions: Penicillin allergy; Sulfonamide allergy (Sulfa based meds allergy),,,"['Lip oedema', 'Mouth swelling', 'Paraesthesia oral']",1,PFIZER\BIONTECH, 1070682,SC,43.0,F,"Red flat itchy rash on torso, face, arms, legs; Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth; Received first dose on 25Jan2021 and second dose on 11Feb2021; Received first dose on 25Jan2021 and second dose on 11Feb2021; This is a spontaneous report from a contactable Other Health Professional. A 43-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266), intramuscularly in Left arm on 11Feb2021 17:15 at single dose for covid-19 immunisation. Medical history included allergy to dairy products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) at the age of 43 years old and Intramuscularly in Left arm on 25Jan2021 17:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth on 12Feb2021 12:00. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has been tested for COVID-19 via Nasal Swab on 02Feb2021 with result Negative. Therapeutic measures (reported as 'IV Epinephrine, Solumedrol, 'Pepcid', 'Benadryl', prednisone) were taken as a result of red flat itchy rash on torso, face, arms, legs, facial swelling, eyes swollen, itchy throat, cotton mouth. The outcome of the events was not recovered. This case reported as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Food allergy,,,"['Dry mouth', 'Eye swelling', 'Inappropriate schedule of product administration', 'Off label use', 'Rash erythematous', 'Rash pruritic', 'SARS-CoV-2 test', 'Swelling face', 'Throat irritation']",2,PFIZER\BIONTECH,OT 1070687,NY,22.0,F,"had chills about 18 hours after; felt cloudy in the head; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received second dose of bnt162b2 (BNT162B2, lot number: EL3247) , via an unspecified route of administration at arm left on 09Feb2021 15:00 at SINGLE DOSE for COVID-19 immunisation. Medical history included inflammatory bowel disease (IBS) from an unknown date. Not Pregnant at the time of vaccination. No allergies to medications, food, or other products.Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included plecanatide (TRULANCE) received within 2 weeks of vaccination. The patient historical vaccine included first dose of bnt162b2 (lot number=EL3247) on 19Jan2021 03:00 PM, at left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No symptoms after the first dose. After the second dose, had chills about 18 hours after and felt cloudy in the head, but was able to go to work and function. Adverse event start date was 10Feb2021 06:30 AM. No treatment received for the adverse event. Event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/10/2021,1.0,WRK,TRULANCE,,Medical History/Concurrent Conditions: Inflammatory bowel disease (IBS),,,"['Chills', 'Feeling abnormal']",2,PFIZER\BIONTECH, 1070690,MA,68.0,F,"Itching head to toes; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 04Feb2021 16:45 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Allergies to medications, food, or other products: pantoprazole sodium sesquihydrate (PAN), codein, clarithromycin (BIAXIN), atropine, pethidine hydrochloride (demerol). The patient experienced itching head to toes (non-serious) on 05Feb2021 with outcome of recovered. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/05/2021,1.0,UNK,,,,,,['Pruritus'],UNK,PFIZER\BIONTECH, 1070697,FL,70.0,F,"all-over body rash that was ""very red, like a tomato""; itchiness; skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen; skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen; redness of the skin; whole body was in pain; severe allergic reaction; felt unwell; Joint muscle pain; flushed red; Tiredness; Injection site pain; joint and muscle pain; joint and muscle pain; white blood cell count on the lower side; possible damage to the kidneys; could have been possible that she had COVID and was asymptomatic, or she had it; cold; not feeling normal; This is a spontaneous report from a contactable consumer (patient) Medical information team. A 70-years-old female patient started to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 13Feb2021 at single dose for COVID-19 immunization. Medical history included dystonia and migraines from an unknown date and unknown if ongoing, COVID-19 antibody test positive from Nov2020 to an unknown date. The patient was taking unspecified concomitant medication for dystonia and migraines. The patient experienced a ""severe allergic reaction"" to her first dose of BNT162B2 in Feb2021. She had all-over body rash that was ""very red, like a tomato"" and showed up 35-40hours after her dose. She states her doctor does not recommend she get the second dose. The patient meant by allergic reaction, she had a number of things, she experienced tiredness, injection site pain, joint muscle pain, she felt unwell, this all happened on the Saturday, the same day she got the vaccine on 13Feb2021. Then on Sunday 14Feb2021, all the symptoms she spoke about were still there and so she rested all day. On 15Feb2021, she looked at her elbows, clarifying the inside of elbow, her elbow creases, and on both elbow creases the skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen down to her thigh, it was working it's way down to the knee, the color was like a beet red, tomato color, it was under the arms, started with elbow, was at her neck. The more down the redness spread, the more it red in color it also got. When she noticed this she called the doctor. When she called the doctor, the doctor said get over to the Emergency Room right away. Her husband and her were both on the phone and were telling the doctor that she doesn't want to go to hospital, she asked if she can just come into the doctors office. The doctor said No. He told her that needs to get special lab work done, and he needs to send her information over to the ER. He said this could do possible damage to the kidneys. The doctor said lets not forget the last time she did a blood test, which was in Nov2020, at that time she came up positive with COVID antibodies. It could have been possible that she had COVID and was asymptomatic, or she had it. The doctor said that they need to do another COVID test or it could be she had a COVID cold or a cold with antibodies, her doctor doesn't know. The fact that she had that test that came back with COVID antibodies test but not have COVID in Nov2020 was something to consider. He was concerned may be there is more to this, or just a rash. The doctor said that he is not equipped say what it should be. The doctor said he will speak with them at the hospital. Tiredness subsided yesterday afternoon on 15Feb2021, it subsided before she went to the ER visit. Right now, it's kind of like a lasting effect because she is not feeling normal. The injection site pain was still there but not as bad. The joint muscle pain subsided this afternoon around 1 o clock. It first began a half hour after leaving the stadium and she was experiencing it while driving back home, the pain continued and got worse. When she got up on Sunday morning her whole body was in pain, she was not getting better on Sunday and that's when she sat on couch rest of the day. For red skin, with the temperature of the skin, she didn't feel it to see if it was hot or anything, it was more this feeling that its just not going away getting worse, it didn't feel hot, there was no texture on the skin either. She just noticed she was flushed red. She called the doctor first, and he said that he was sending information to the emergency room. Then she went to (name of place withheld) ER. They took her temperature, there was no fever. She was then relieved from the ER in 2.5 hours and went home. She still has redness on the skin. In the hospital, they gave her 40 mg of prednisone and an injection or Benadryl, and prescription for prednisone to take for the next 4 days while tapering down. She did take Benadryl about 2 hours ago, she did notice all the sudden she was getting itchy. She is less itchy now. With the itchiness, she just observed this about 2 hours ago. She took Benadryl, she has somewhat improved, she is still itchy but not to the point that she will scratch heavily. She does not have her COVID CDC Card at the moment, her husband has that information but he is on a conference call with a client and she cant disturb him. The patient was scheduled for a second dose on 06Mar2021. That's where she has a question, the doctor is saying that he is not sure about getting second shot. They took lab work at the hospital and said everything was fine except for white blood cell count, it was on the lower side in Feb2021. She has had no vaccines on the same day or in the 4 weeks prior. She hasn't had any vaccines. She did have to visit the emergency room. She only called the doctors office, the doctor said not to come in and go tot he ER. She has No relevant family medical history that she would like to share. The severe allergic reaction, ""skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen"", injection site pain, redness of the skin, itchiness, joint muscle pain and whole body was in pain was recovering. The event tiredness recovered with sequelae on 15Feb2021 and the event joint and muscle pain was recovered on 16Feb2021. The outcome of the remaining events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: COVID-19 antibody test positive; Dystonia; Migraine,,,"['Angioedema', 'Arthralgia', 'Body temperature', 'Erythema', 'Fatigue', 'Feeling abnormal', 'Flushing', 'Hypersensitivity', 'Malaise', 'Musculoskeletal pain', 'Myalgia', 'Nasopharyngitis', 'Pain', 'Pruritus', 'Rash erythematous', 'Renal disorder', 'Skin swelling', 'Suspected COVID-19', 'Vaccination site pain', 'White blood cell count', 'White blood cell count decreased']",1,PFIZER\BIONTECH, 1070698,,,U,"Bells Palsy; This is a spontaneous report from Pfizer-sponsored program. A contactable healthcare professional reported that a patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, first dose on 27Jan2021 at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient received first COVID vaccine 27Jan2021 and was diagnosed with Bells Palsy on 10Feb2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bell's palsy cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,02/10/2021,14.0,UNK,,,,,,"[""Bell's palsy""]",1,PFIZER\BIONTECH, 1070699,NJ,27.0,F,"Angioedema; swelling; Difficulty breathing; Tight chest; Facial flushing; Dry eyes and unsettled stomach; Dry eyes and unsettled stomach; This is a spontaneous report from a contactable nurse. A 27-years-old non-pregnant female patient started treceive bnt162b2 (BNT162B2), Lot number: EL9266, intramuscular in left arm on 15Feb2021 at 0900 (at the age of 27 years-old) for COVID-19 immunzation. The vaccination was administered at a workplace clinic. Medical history included Allergy/Sports-Induced Asthma, Lactose Intolerant and food allergies of Kiwi, Lactose Intolerant, Cherry. The patient had a positive COVID-19 test prior to vaccination on 14Nov2020. There was no other vaccinations given within 4 week and concomitant medications within 2 weeks included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), fish oil (FISH OIL). On 15Feb2021 at 10:00, the patient experienced Angioedema/swelling, Difficulty breathing/tight chest, facial flushing, dry eyes and unsettled stomach. Experienced symptoms of flushing 1hour post-vaccination. The clinical course was as follows: She reported that she experienced symptoms of flushing 1hour post-vaccination. About 4 hours later swelling persisted and took Zyrtec to alleviate symptoms, which provided minimal relief. 24 hours post vaccination resulted in ER admission advised per Occupational Medicine at (name). IV SoluMedrol, Bendaryl and Pepcid administered. Overall stay in ER 3 hours. On 17Feb2021, 24 hours post admission rebound symptoms occurring with facial flushing and swelling. Will repeat allergy medication to relieve symptoms PRN. The clinical outcome of the events was recovered with sequalae (as reported by patient: recovered with lasting effects).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/15/2021,0.0,WRK,LO LOESTRIN FE; ZYRTEC-D; VITAMIN C [ASCORBIC ACID]; FISH OIL,,"Medical History/Concurrent Conditions: Asthma (Allergy/Sports-Induced Asthma, Lactose Intolerant); COVID-19; Food allergy (known allergies: Kiwi, Lactose Intolerant, Cherry); Lactose intolerant",,,"['Abdominal discomfort', 'Angioedema', 'Chest discomfort', 'Dry eye', 'Dyspnoea', 'Flushing', 'Swelling']",1,PFIZER\BIONTECH,OT 1070700,GA,33.0,F,"Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normally; dizzy; nauseous; flu like symptoms; shooting sensations down both arms; memory issues; joint pain; headaches; varying rashes; trouble speaking, thinking, and understanding; trouble speaking, thinking, and understanding; This is a spontaneous report from a contactable nurse (the patient). A non-pregnant 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 11Jan20210 at 07:30 AM (at the age of 33-years) as a single dose for COVID-19 immunization. Medical history included migraines. The patient had known allergies to Sulfa, and codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on unspecified date for COVID-19 immunization. On 11Jan2021 at 10:15 AM, the patient experience vertigo (reported as caused disability); fluid in ears and lungs, muscle weakness, inability to walk normally, dizzy, nauseous, flu like symptoms for two weeks, shooting sensations down both arms, , memory issues, trouble speaking, thinking, and understanding, joint pain, headaches, varying rashes that she have never experienced on my body in various areas. The patient visited the physician office and had an emergency room visit due to the events. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and it was negative on 03Feb2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vertigo and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/11/2021,01/11/2021,0.0,PVT,,,"Medical History/Concurrent Conditions: Migraine; Sulfonamide allergy (known allergies : Sulfa, codeine)",,,"['Arthralgia', 'Cognitive disorder', 'Dizziness', 'Gait disturbance', 'Headache', 'Influenza like illness', 'Memory impairment', 'Middle ear effusion', 'Muscular weakness', 'Nausea', 'Pain', 'Pleural effusion', 'Rash', 'SARS-CoV-2 test', 'Speech disorder', 'Vertigo']",2,PFIZER\BIONTECH, 1070701,NY,,F,"couldn't walk; could not move her legs, her waist, and her hips; This is a spontaneous report from a contactable consumer, the patient. This 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 2 , single dose via an unspecified route of administration for COVID-19 vaccination on 14Jan2021. Medical history and concomitant medication were not reported. On 15Jan2021, the patient couldn't walk and could not move her legs, her waist, and her hips. This has never happened before. It has been a month since the incident happened and it has not been resolved. She has been in the hospital for 6 days now receiving physical therapy and is waiting for a follow up appointment from her doctor. She is using a walker to assist her in walking. The clinical outcomes of events couldn't walk and could not move her legs, her waist, and her hips is not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/14/2021,01/15/2021,1.0,UNK,,,,,,"['Gait inability', 'Movement disorder']",2,PFIZER\BIONTECH, 1070702,MO,43.0,M,"felt a little colder than usual; trouble falling asleep; general feeling of malaise; pressure building in my head and abdomen; pressure building in my head and abdomen; left shoulder became increasing sore over 24 hours; This is a spontaneous report from a contactable consumer reported for himself that: 43-years-old male patient started to receive the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 16Feb2021 15:45 at single dose at left arm for covid-19 immunisation. The patient previously took the first dose bnt162b2 on 26Jan2021 at 43 years old for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced left shoulder became increasing sore over 24 hours on 16Feb2021 15:45, trouble falling asleep on 17Feb2021 04:00, general feeling of malaise, pressure building in my head and abdomen on 17Feb2021, felt a little colder than usual on 17Feb2021 08:30. No treatment was received for the adverse events. Under the tongue temperature reading was 97.9 (The patient was usually 97.5 with this thermometer) on 17Feb2021. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/16/2021,0.0,WRK,,,,,,"['Abdominal discomfort', 'Arthralgia', 'Body temperature', 'Feeling cold', 'Head discomfort', 'Initial insomnia', 'Malaise']",2,PFIZER\BIONTECH, 1070705,CT,35.0,F,"nausea - 6hrs post shot; headache -10hrs; body aches-14hrs; chills - 14hrs; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on left arm on 16Feb2021 11:30 AM at single dose for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included hypothyroid, Allergies to amoxicillin and sulfa drugs. Concomitant medication (received within 2 weeks of vaccination) included levothyroxine sodium (SYNTHROID), buspirone hydrochloride (BUSPAR) and vitamin D. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation on 26Jan2021 at age of 35 years old. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Feb2021, the patient experienced nausea - 6hrs post shot, headache - 10hrs, body aches and chills - 14hrs. The outcome of events was not recovered. No treatment received for the adverse events. All events reported as non-serious. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/16/2021,0.0,WRK,SYNTHROID; BUSPAR; VITAMIN D,,Medical History/Concurrent Conditions: Hypothyroidism (hypothryoid); Sulfonamide allergy (known_allergies: sulfa drugs),,,"['Chills', 'Headache', 'Nausea', 'Pain']",2,PFIZER\BIONTECH, 1070711,FL,67.0,M,"stroke; Joint pain; In the palm of my hand I might jump out of my skin; ; arm was hardly sore at all; right arm at the shoulder, elbow, and fingers is hurting at the joints; This is a spontaneous report from a contactable consumer. This 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9269) single dose, dose 1 via unknown route of administration in the left arm for COVID-19 vaccination on 12Feb2021 at 14:30. There were no additional vaccines administered on the same date as the COVID-19 vaccine. Medical history included pneumonia five times on an unknown date, septicemia one time, melanoma cancer in 2015, Factor V Leiden, high blood pressure and blood thinner. Prior Vaccinations (within 4 weeks): Concomitant medications included lisinopril from 2008 and ongoing for high blood pressure and warfarin 9.5 mg daily from 2008 and ongoing for blood thinner. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On an unknown date, the patient's arm was hardly sore at all and he had a stroke. On 13Feb2021, the patient experienced joint pain, in the palm of his hand if he presses right in the dead center he thinks he is going to jump out of the skin and right arm at the shoulder, elbow and fingers is hurting at the joints. When he first felt it in his right arm it wasn't horrible and it seemed like it got worse the next day. Then it seemed like it tapered off a little bit. On 16Feb2021, the pain woke him up in the middle of the night. The events did not require an emergency room or physician's office visit. He gets the flu shot every year and he has no symptoms whatsoever. The clinical outcome of stroke, joint pain, in the palm of my hand I might jump out of my skin, arm was hardly sore at all and right arm at the shoulder, elbow, and fingers is hurting at the joints were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/13/2021,1.0,OTH,LISINOPRIL; WARFARIN,,Medical History/Concurrent Conditions: Anticoagulant therapy (~~~); Blood pressure high (~~~); Factor V Leiden thrombophilia; Melanoma; Pneumonia (pneumonia five times); Septicemia (septicemia one time),,,"['Arthralgia', 'Cerebrovascular accident', 'Computerised tomogram', 'Musculoskeletal pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 1070713,VA,78.0,F,"3rd Troponin level increased from 2nd Troponin; rapid heart beat / rapid pulse / pulse was up some; burning in her chest and throat / her throat was irritated; burning in her chest and throat; blood pressure keeps going up and down; fatigue; felt run down; This is a spontaneous report from a contactable nurse, the patient. A 78-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL8982), via an unspecified route of administration in the right deltoid on 04Feb2021 at 16:55 (at the age of 78-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. There were no prior vaccinations (within 4 weeks) of BNT162B2. The patient previously received the flu vaccine (manufacturer unspecified) on 25Sep2020, as well as the shingles, pneumonia and Tdap vaccines (manufacturers unspecified) all on unspecified dates for immunization. On 04Feb2021, between 17:25-17:30, the patient developed a rapid heartbeat and burning in her chest and throat. She reported that her throat was irritated, as of 04Feb2021. She clarified the burning sensation was as if someone had heated a gel pack in the microwave and then placed the heated gel pack on her chest and throat area. She went to the Emergency Room (ER). She still had a rapid pulse, so the ER doctor did a series of cardiac enzyme tests (troponin). Her first troponin on 04Feb2021 was negative. The second cardiac enzyme test was done 3 hours later, on 04Feb2021, and the troponin went up a little. The third cardiac enzyme test was taken at 1:30 on 05Feb2021. The ER doctor didn't think it was necessary to keep her in the ER, so he suggested she go home. When she left the ER, her pulse was up some, but not like when she first went to the ER. At the ER, she was not given any medications. She only had the cardiac enzyme tests, and EKGs (unknown results) performed. She had a Heplock placed but received no intravenous fluids. She was woken up by the ER doctor who told her she needed to go back for more tests as he was concerned that she may have heart damage. The ER doctor said her 3rd Troponin went up more than her 2nd Troponin. At 6:50 on 05Feb2021 she had another cardiac enzyme test and was told she needed to have an echocardiogram. The echocardiogram (05Feb2021) showed no heart damage. The cardiologist said her heart was beating fine and that the COVID-19 vaccine may have elevated her pulse, but he felt there was no damage to her heart. The patient experienced fatigue as of an unknown date in Feb2021 (maybe 05Feb2021 or 06Feb2021 or 07Feb2021). On an unspecified date in Feb2021 (after 05Feb2021), the patient felt run down. The patient reported her blood pressure kept going up and down since the vaccination, as of 04Feb2021. She saw her health care professional (HCP) on 11Feb2021 to pick up new prescriptions. On 12Feb2021, she started to keep a record of her blood pressure readings. One day her systolic blood pressure was 170 ""over something"", and then the next day her systolic blood pressure was down, as far as 103. The HCP recommended she see an allergist before she received the second dose of the COVID-19 vaccine. She said both the medical doctor and cardiologist said it was OK for her to get the second COVID-19 vaccine (scheduled for 25Feb2021). The patient was unsure if the COVID-19 vaccine caused her symptoms. The reporter considered ""rapid heartbeat / rapid pulse / pulse was up some"", ""burning in her chest and throat / her throat was irritated"", ""blood pressure keeps going up and down"" as medically significant; and fatigue and felt run down as non-serious. The patient received unspecified treatment for the events. The clinical outcome of ""rapid heartbeat / rapid pulse / pulse was up some"", ""3rd Troponin level increased from 2nd Troponin"" was unknown; ""burning in her chest and throat / her throat was irritated"" was resolved on Feb2021; ""blood pressure keeps going up and down"" was not resolved; fatigue and felt run down was resolving.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of rapid heartbeat and other events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this elderly patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, chemistry panel and echocardiogram, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Blood pressure fluctuation', 'Blood pressure measurement', 'Blood pressure systolic', 'Chest pain', 'Echocardiogram', 'Electrocardiogram', 'Fatigue', 'Heart rate', 'Heart rate increased', 'Lethargy', 'Throat irritation', 'Troponin', 'Troponin increased']",1,PFIZER\BIONTECH, 1070714,CA,77.0,F,"she was hospitalized 2.5 days after having symptoms of a ""massive heart attack"" 2 days after the vaccine; blood clot; pain on the left side/pain so bad/ pain was so severe couldn't bent over and couldn't get up; pain was in the heart and underneath the rib; pain was in the heart and underneath the rib; had a little trouble breathing; broke out in a sweat; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date in Feb2021 at a single dose for COVID-19 immunization. Medical history included asthmatic, had double pneumonia years ago, has ongoing atrial fibrillation and a pacemaker to control it as the only problem she has in her heart. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient was hospitalized for 2.5 days after having symptoms of a massive heart attack two days after the vaccine. It was reported that two days post vaccination, the patient was rushed to the hospital by ambulance as they thought she was having a massive heart attack. She added her symptoms lasted for hours, she had pain so bad that she was bent over and had a little trouble breathing. She said the pain was in the heart and underneath the rib, on the left side. She later mentioned she did not feel like it was AFib. She said they did every test possible and listed the following ones: ultrasound, stress test, x-ray (unknown results), and blood work in Feb2021. She specified that her blood work indicated a blood clot. She mentioned she was told by her personal friend, who was a doctor, that by having the shot sometimes it indicated you have blood clots when you really don't. The patient also specified that she broke out in a sweat, the pain was so severe that she could not bend over and could not get up; therefore, they treated her as if she was having a massive heart attack for 12 hours at the hospital. It was reported that they kept giving her stuff to stop the effect with her heart. She mentioned her second dose was scheduled on 25Feb2021. She asked if her experience was reported as a side effect to the vaccine and should she get the second dose of the vaccine. She explained the doctors did not know what she had, and she needed to determine if she can receive the second dose. She also asked if we could notify her if a similar reaction is reported. The outcome of the events was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,Artificial cardiac pacemaker user; Atrial fibrillation,Medical History/Concurrent Conditions: Asthmatic; Pneumonia,,,"['Angina pectoris', 'Blood test', 'Cardiac stress test', 'Dyspnoea', 'Hyperhidrosis', 'Musculoskeletal chest pain', 'Myocardial infarction', 'Pain', 'Thrombosis', 'Ultrasound scan', 'X-ray']",1,PFIZER\BIONTECH, 1070715,MN,35.0,F,"had tunnel vision ups on walking to bathroom and almost blacked out; had tunnel vision ups on walking to bathroom and almost blacked out; Achy and restless legs; Achy and restless legs; nauseous however did not allow self to vomit; headache; fatigue; rapid heart beat; low grade fever; chills; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EM9809) via an unspecified route of administration on 16Feb2021 12:45 at single dose (left arm) for COVID-19 immunization. Medical history included hypothyroidism, and allergies: Sulfa. The patient was not pregnant. Concomitant medication included topiramate (TOPIMAX), metformin, levothyroxine, and phentermine. The patient received 1st dose of bnt162b2 for COVID-19 immunization on 26Jan2021, 12:45pm (lot EL9263). On 17Feb2021 03:30, the patient experienced achy and restless legs, nauseous however did not allow self to vomit, had tunnel vision ups on walking to bathroom and almost blacked out, headache, fatigue, rapid heart beat, low grade fever, and chills. The patient had no treatment for the events. The patient had no other vaccine in four weeks and had no covid prior vaccination. Patient was not covid tested post vaccination. Outcome of events was recovering.; Sender's Comments: A possible contribution role of the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of Tunnel vision cannot be completely excluded due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,PVT,TOPIMAX [TOPIRAMATE]; METFORMIN; LEVOTHYROXINE; PHENTERMINE,,Medical History/Concurrent Conditions: Hypothyroidism; Sulfonamide allergy,,,"['Body temperature', 'Chills', 'Fatigue', 'Headache', 'Heart rate', 'Heart rate increased', 'Nausea', 'Pain in extremity', 'Presyncope', 'Pyrexia', 'Restless legs syndrome', 'Tunnel vision']",2,PFIZER\BIONTECH, 1070716,,,M,"face paralysis; This is a spontaneous report from a contactable consumer reporting on behalf of her husband. A 43 year old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 06Feb2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medications were not reported. The reporter stated her husband received the first dose of the COVID 19 vaccine on 06Feb2021 and was scheduled for the second dose on 19Feb2021 He woke up today (18Feb) with face paralysis. He went to the doctor, got a CT scan and other studies, and everything is normal. The reported stated that the doctor said it was probably the vaccine. Doctor prescribed medication and told him not to get the second dose. Lab data included CT scan and ""other studies"" on 18Feb2021 which were normal. The clinical outcomes of facial paralysis was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/06/2021,02/18/2021,12.0,UNK,,,,,,"['Computerised tomogram', 'Facial paralysis', 'Investigation']",1,PFIZER\BIONTECH, 1070717,IL,,M,"in hospital because he caught the covid virus; pneumonia; positive when they were going to send him to rehab; positive when they were going to send him to rehab; This is a spontaneous report from contactable consumers (patient's wife and son). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified as a SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (it was just under 100 days since he had COVID). The patient's concomitant medications were not reported. The consumer reported her husband is in hospital because he caught the covid virus on an unknown date. The consumer was with her son who added some additional information stating that at first they had his father in the hospital because he had pneumonia on unknown date. He tested negative [for Covid-19] the first two times and then was positive when they were going to send him to rehab. They think it was false positive because it was just under 100 days since he had COVID and he didn't have any symptoms. They say you can test for Covid-19 4 or 5 months after Covid and still test positive. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: COVID-19 (it was just under 100 days since he had COVID),,,"['COVID-19', 'Drug ineffective', 'Pneumonia', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1070718,MI,56.0,F,"Bleeding upon injection; large bruise; extreme nausea; chills; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) solution for injection, via an unspecified route of administration at right arm on 11Feb2021 at 4:15 PM at single dose for COVID-19 immunization. Medical history included allergies to penicillin, glaucoma (reported as glaucomo) and high blood pressure. Concomitant medication included metroprolol. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 20Jan2021 at single dose for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at a hospital. There was no other vaccine in four weeks. The patient was no COVID prior to vaccination and she was not tested for COVID post vaccination. The patient experienced bleeding upon injection, large bruise, extreme nausea, chills, fatigue, and headache, all on 12Feb2021 at 04:00 AM. She did not receive any treatment in response to the events. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/12/2021,1.0,PVT,METOPROLOL,,Medical History/Concurrent Conditions: Blood pressure high; Glaucoma; Penicillin allergy,,,"['Chills', 'Contusion', 'Fatigue', 'Haemorrhage', 'Headache', 'Nausea']",2,PFIZER\BIONTECH, 1070719,GA,,F,"brain pain and the neck pain being a possible encephalitis; some nodules under the arm and leg; right shoulder pain at the site of an old shoulder injury; pain under her arm and into her right breast that started on Saturday with nodules; nodules in her right leg that hurt; headache at the base of her brain and in front; intense neck pain; joints aching/all her joints ache; felt queasy; had sharp pain in both eyes; brain fog; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EM9810) , via an unspecified route of administration on 09Feb2021 at 11:30 (at the age of 67 years old) on left arm at single dose for covid-19 immunisation at a mall vaccination facility. The patient medical history was none. There were no concomitant medications. The patient stated she had some pretty severe reactions after getting the first dose of the Pfizer COVID 19 vaccine on 09Feb2021 at 1130AM in the left arm. The patient experienced ""brain pain and the neck pain being a possible encephalitis"" on an unspecified date with outcome of unknown , intense neck pain on 10Feb2021 to 13Feb2021 with outcome of recovered , joints aching/all her joints ache on 10Feb2021 to 18Feb2021 with outcome of recovered , felt queasy on 10Feb2021 to 12Feb2021 with outcome of recovered , had sharp pain in both eyes on 10Feb2021 to 12Feb2021 with outcome of recovered , brain fog on 10Feb2021 to 13Feb2021 with outcome of recovered , some nodules under the arm and leg on 13Feb2021 with outcome of not recovered , headache at the base of her brain and in front on 10Feb2021 to 13Feb2021 with outcome of recovered , right shoulder pain at the site of an old shoulder injury on 13Feb2021 to 13Feb2021 with outcome of recovered , pain under her arm and into her right breast that started on Saturday with nodules on 13Feb2021 and ongoing with outcome of recovering, and nodules in her right leg that hurt on 13feb2021 with outcome of not recovered. She was afraid of getting the second dose and inquired advice about getting the second shot. Relevant tests were none.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/10/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Arthralgia', 'Breast pain', 'Encephalitis', 'Eye pain', 'Feeling abnormal', 'Headache', 'Nausea', 'Neck pain', 'Nodule']",1,PFIZER\BIONTECH, 1070720,,,M,"seeing people/things that are not there; having psychosis issues; This is a spontaneous report received from a contactable consumer via a Pfizer-sponsored program. This consumer reported for a patient (father) that: A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on an unknown date in Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller states that his dad had the first dose of the COVID-19 Shot a little over two weeks ago in Feb2021. Caller stated that lately in Feb2021, his dad was having psychosis issues, and was seeing people/things that are not there. The outcome of the events was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,,,,,"['Hallucination, visual', 'Psychotic disorder']",1,PFIZER\BIONTECH, 1070721,CA,79.0,F,"She did have an inflamed shoulder prior, it has been pretty good lately but flared up after the vaccine/She does have rheumatoid arthritis in right shoulder and arm; right shoulder and right arm felt sore and achy/ right arm and shoulder were aching; right shoulder and right arm felt sore and achy/ right arm and shoulder were aching; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection lot number: EN6201), intramuscular at upper left arm on 17Feb2021 10:15 at a single dose for COVID-19 immunization. Medical history included ongoing Rheumatoid arthritis (arthritis in right shoulder and arm gets inflamed and sore; rheumatoid arthritis in right shoulder and arm. It sometimes flares up and gets sore) diagnosed in late 2019, ongoing Autoimmune deficiency disease diagnosed in late 2019 and lower left eyelid which was inverted. There were no concomitant medications. No prior vaccinations (within 4 weeks). The patient previously took Shingrix vaccine (Shingles vaccine) at left arm last year-2020 and she felt soreness and achiness in right shoulder and arm. The patient received the first dose of the Pfizer COVID-19 vaccine yesterday on 17Feb2021 at her left arm. A few hours later her right shoulder and right arm felt sore and achy. On 18Feb2021, the patient's right arm and shoulder were aching. The patient mentioned that this has also happened last year when she had a Shingrix vaccine. She was also injected in her left arm but her right arm got sore and achy. She felt soreness and achiness in right shoulder and arm. She wanted to know if this is a normal reaction from the vaccine. The patient stated that it was weird. On unspecified date, when she lifts her arm up high it hurts, she stated that she does have an inflamed shoulder. She did have an inflamed shoulder prior, it has been pretty good lately but flared up after the vaccine. During the night it was very bad. She does have rheumatoid arthritis in right shoulder and arm. It sometimes flares up and gets sore. She was wondering if there is a relationship with the COVID 19 vaccine because she felt like she got the COVID 19 vaccine in the right arm, she asked if she's reacting to the medication. No treatment was administered for right shoulder. Routine lab work done on 02Feb2021 but it has nothing to do with this. The events did not require a visit to Emergency Room or Physician Office. The patient is also scheduled to have Botox in her lower eyelid for her left eye to release the nerve muscle. She asked if it is ok since she just had the Pfizer COVID-19 vaccine. She is scheduled to get botox injection next week for lower left eyelid which is inverted, it was bothering her. They have to release the muscle by getting an injection of botox. She was receiving conflicting information from her PCP, who says wait a month and her ophthalmologist who says its ok to get the COVID 19 vaccine. She thought she heard something about not mixing botox with the vaccine. The outcome of the event ""She did have an inflamed shoulder prior, it has been pretty good lately but flared up after the vaccine/She does have rheumatoid arthritis in right shoulder and arm"" was unknown; and other events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,UNK,,Autoimmune deficiency syndrome; Rheumatoid arthritis,Medical History/Concurrent Conditions: Entropion,,,"['Arthralgia', 'Laboratory test', 'Pain in extremity', 'Rheumatoid arthritis']",1,PFIZER\BIONTECH,OT 1070722,,,F,"felt like I was getting COVID again; felt like I was getting COVID again; could barely walk; chills; nauseated; wasn't breathing well; swollen, red cheeks; red cheeks; headache; constant pain in my body; fever never got higher than 99.46F; A 94-years-old female patient received the first dose of dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. Medical history included covid-19 from Mar2020. Concomitant medication included Tylenol and Tramadol. The patient reported that the evening I got the first dose, I had chills for 24 hours, I was nauseated, I wasn't breathing well. I had swollen, red cheeks. My fever never got higher than 99.46F. I called because I could barely walk. I went to the hospital. I felt like I was getting COVID again. I took me about 3 days to get over the side effects. I had a bad headache. I told the doctor in the ER my problem and he asked why I thought it was reaction. I'm 94 years old. I take Tylenol every day. I take Tramadol for constant pain in my body. I finally just told them I wanted to go home; they weren't doing anything for me at the hospital. The outcome of the events chills, nauseated, wasn't breathing well, swollen, red cheeks, fever never got higher than 99.46F, I could barely walk, felt like I was getting COVID again, bad headache was unknown. Information on Lot/Batch number requested",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,TYLENOL; TRAMADOL,,Medical History/Concurrent Conditions: COVID-19,,,"['Body temperature', 'Chills', 'Drug ineffective', 'Dyspnoea', 'Erythema', 'Gait disturbance', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Suspected COVID-19', 'Swelling face']",1,PFIZER\BIONTECH, 1070723,FL,90.0,M,"Coughing; wheezing; shortness of breath; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 90 years, first dose on 19Jan2021 09:00 (lot number: EK4176) and second dose on 09Feb2021 (lot number EL9261); via unspecified routes of administration on the left arm at single doses for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included losartan, terazosin, melatonin, glipizide, linagliptin (TRAJENTA), clopidogrel bisulfate (PLAVIX), clopidogrel bisulfate, citalopram, zinc, famotidine, amino acids nos (PROTINEX) and colecalciferol (VITAMIN D). On 20Jan2021, the patient experienced coughing, wheezing and shortness of breath. The patient was taken to the ER and put in the hospital for five days (date of hospitalization was unknown). Treatment received by the patient was unknown. Lab data includes COVID test: Unknown results on an unspecified date. The outcome of the events was recovered with sequelae on an unspecified date.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/19/2021,01/20/2021,1.0,PVT,LOSARTAN; TERAZOSIN; MELATONIN; GLIPIZIDE; TRAJENTA; PLAVIX; CLOPIGREL; CITALOPRAM; ZINC; FAMOTIDINE; PROTINEX; VITAMIN D [COLECALCIFEROL],,,,,"['Cough', 'Dyspnoea', 'SARS-CoV-2 test', 'Wheezing']",1,PFIZER\BIONTECH, 1070724,,,F,"acute myeloid leukemia; her platelets were below 30,000; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 12Feb2021 at single dose for COVID-19 immunization. Medical history included ongoing immunodeficiency (reported as immunocompromised). Concomitant medications were not reported. The patient had an acute myeloid leukemia and her platelets were below 30,000 on an unspecified date. Clinical outcome of the events was unknown. Information on about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,,,UNK,,,Medical History/Concurrent Conditions: Immunocompromised,,,"['Acute myeloid leukaemia', 'Platelet count', 'Platelet count decreased']",1,PFIZER\BIONTECH, 1070725,NY,69.0,F,"shaking; chills; headache; diarrhea; overall body aches; This is a spontaneous report from a contactable pharmacist. A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 vaccination. Medical history included she was previously positive for Covid in Oct2020 to an unspecified date and she received monoclonal antibody treatment (Remdesivir) 3 months prior to her first dose of the vaccine; patient had COPD, oxygen dependent and diabetes from 2016 to an unknown date; and obesity in 2014 to an unknown date. There were no concomitant medications which was reported as patient had not had any other recent vaccinations or started any new medications. Patient received monoclonal antibody treatment 3 months prior to her first dose of the vaccine. Patient probably tested positive and was treated probably the same day she had the positive test (in Oct2020), reporter was sure all of this happened at the hospital, but he doesn't have that information, and the COVID test type was unknown. Reporter's question was related to information about this specific type of patient, having received the monoclonal antibody treatment on 12Oct2020, to an unknown date, which was Remdesivir and also having had COVID then, then having reactions to the dose, would the second dose be necessary, effective, or safe to give to this patient. The patient had her first dose of the Pfizer Covid vaccine 3 weeks ago (estimated as 27Jan2021 by standing order and not prescribed). The patient had general same symptoms listed for side effects of the vaccine that were more severe than others. The patient experienced effects after the first dose of the vaccine as shaking and chills for two days, and headache, diarrhea, and overall body aches (Jan2021). Reporter wanted to know of any studies or research on patients who have been positive for Covid 19 prior to getting the vaccine and treated with monoclonal antibodies and if they do have similar titers to those who have been vaccinated. The reporting pharmacist that the events were serious, and he thought these were medically significant. The patient's symptoms resolved after 72 hours, and reporter did not believe that they did any treatment other than to sleep. The events recovered on an unspecified date in 2021. Information about Lot/ Batch number requested; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events tremor, chills, headache, diarrhoea and pain cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: COPD; COVID-19 (received monoclonal antibody treatment 3 months prior to her first dose of the vaccine.); COVID-19 virus test positive; Diabetes; Obesity; Oxygen therapy,,,"['Chills', 'Diarrhoea', 'Headache', 'Investigation', 'Pain', 'Tremor']",1,PFIZER\BIONTECH, 1070726,PA,28.0,M,"Had severe chest pains and pain radiating down left arm three (3) days; Had severe chest pains and pain radiating down left arm three (3) days; I was diagnosed with myopericarditis (inflammation of both the lining of the heart and the heart muscle); This is a spontaneous report from a contactable consumer. This 28-year-old male consumer reported that: Report about Covid vaccine: Yes Reporting type: AE Reporter type: Patient Age group: Adult (18-64 Years) Current age: 28 Current age unit: Years Gender: Male Patient occupation: None of the above Covid vaccine details: (product=COVID 19, brand=Pfizer, lot number=EL3246, lot unknown= False, administration date=18Jan2021, administration time= 04:00 PM, vaccine location= Right arm, dose number= 2), (product= COVID 19, brand=Pfizer, lot number= EJ1685, lot unknown= False, administration date= 29Dec2020, administration time=11:00 AM, vaccine location= Right arm, dose number=1) Facility type vaccine: Hospital If other vaccine in fourweeks: No Other medications in twoweeks: No Adverse event: Had severe chest pains and pain radiating down left arm three (3) days (Thursday 21Jan2021) after receiving the second Pfizer COVID vaccine (lot:EL3246) on Monday 18Jan2021. I was admitted to the hospital the same day, and was discharged on Saturday 23Jan2021. I was diagnosed with myopericarditis (inflammation of both the lining of the heart and the heart muscle). I was given a 90 day prescription of colchicine 0.6mg and I am still currently taking the medication twice daily with 1g of Tylenol (acetaminophen) once daily. Adverse event start date: 21Jan2021 Adverse event start time: 03:00 AM AE resulted in: [Emergency room/department or urgent care, Hospitalization] No days hospitalization: 3 If patient recovered: Recovered If treatment AE: Yes AE treatment: Colchicine 0.6 mg tablet (twice daily) If Covid prior vaccination: No If Covid tested post vaccination: Yes Covid test post vaccination: (covid test type post vaccination=Nasal Swab, covid test date=21Jan2021, covid test result=Negative) Known allergies: Penicillin/Amoxicillin Other medical history: No",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/18/2021,01/21/2021,3.0,PVT,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Chest pain', 'Investigation', 'Myocarditis', 'Pain in extremity']",2,PFIZER\BIONTECH, 1070727,CA,65.0,M,"optic neuritis; This is a spontaneous report from a contactable physician. A 65-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. Medical history included lost vision in one eye on unspecified date, 20 years ago in the military. Concomitant medications were not reported. After 2 days, on 06Feb2021, the patient developed severe optic neuritis in one eye. Event was assessed as serious, medically significant. The patient is getting a fairly extensive workup. He was getting labs (unspecified) and will get 1 gram a day of Solumedrol for three days followed by oral Prednisone. He was going to get the typical. Outcome of the event was unknown. Information on Lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/06/2021,2.0,UNK,,,Medical History/Concurrent Conditions: Vision loss (The other eye he lost vision in 20 years ago in the military),,,['Optic neuritis'],1,PFIZER\BIONTECH, 1070728,SC,75.0,M,"Became unresponsive for a short period on the way to the ER after vomiting; Became so sick and weak within 2 hours needed to seek medical help at the ER; Became so sick and weak within 2 hours needed to seek medical help at the ER; Uncontrollable cough; low grade fever; muscle aches; nausea; violent projectile vomiting; This is a spontaneous report from a contactable consumer (patient) A 75 years old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 12Feb2021 at 14:30 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included lung cancer on 2007, Covid 19 infection on an unspecified date prior vaccination. The patient received first dose of BNT162B2 on 21Jan2021 at 15:00 in left arm. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and pravastin. On 13Feb2021 at 13:00 the patient started experiencing uncontrollable cough, low grade fever, muscle aches, nausea, violent projectile vomiting. He became so sick and weak within 2 hours needed to seek medical help at the ER. It was also informed that patient became unresponsive for a short period on the way to the ER after vomiting. Treatment received included Zofran, LR (IV fluids). The patient recovered from became unresponsive on 13Feb2021. At the time of the reporting the patient was recovering from the events. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,PVT,ASPIRIN [ACETYLSALICYLIC ACID]; PRAVASTATIN,,Medical History/Concurrent Conditions: COVID-19 (If covid prior vaccination: Yes); Lung cancer (Lung cancer 2007- recovered),,,"['Asthenia', 'Cough', 'Illness', 'Myalgia', 'Nausea', 'Pyrexia', 'Unresponsive to stimuli', 'Vomiting projectile']",2,PFIZER\BIONTECH, 1070729,NY,,F,"heard a loud bang in my brain; blacked out for an instant; tired and wobbly; Did not get my balance/wobbly; 1,Day after the vaccine, I had violent projectile diarrhea; This is a spontaneous report from a contactable consumer (patient). An 83 year-old elderly female patient received first dose of BNT162B2 (lot number: EL3247), via an unspecified route of administration from 20Jan2021 20:30 at single dose in the right arm for COVID-19 immunisation. Medical history included small cell lung, 2cm, no follow -up treatment necessary. No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID), and losartan potassium. One day after the vaccine administration on 21Jan2021 10:00, the patient had violent projectile diarrhea. Two days after the vaccine, she blacked out for an instant and heard a loud bang in her brain. She was tired and wobbly for over one week. She did not get her balance back for nearly 3 weeks. The events resulted in Disability or permanent damage. Treatment for the events was unknown. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/20/2021,01/21/2021,1.0,UNK,SYNTHROID; LOSARTAN POTASSIUM,,"Medical History/Concurrent Conditions: Small cell lung cancer (Small cell lung cancer, 2cm, no follow up treatment necessary)",,,"['Balance disorder', 'Diarrhoea', 'Fatigue', 'Hallucination, auditory', 'Loss of consciousness']",1,PFIZER\BIONTECH, 1070730,MO,72.0,F,"hands, feet, toes and entire body, felt almost paralyzed; not being able to turn over in bed; could not bend her fingers or toes; muscles throughout her body remained stiff and tight; could not bend her fingers or toes; muscles throughout her body remained stiff and tight; tense muscle aches; Chills; headache; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) at the age of 72-years, via an unspecified route of administration in left arm at 11:00 AM on 16Feb2021 at single dose for COVID-19 immunisation, in hospital. Medical history included pituitary microadenoma from 1969 (52 years) and in good health other than the fibromyalgia; allergies to latex. Patient was not pregnant, was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included desipramine; duloxetine hydrochloride (CYMBALTA); ergocalciferol (VIT D); zinc. The patient previously received first single dose of BNT162B2 (lot number: EK9231) at the age of 72-years via an unspecified route of administration in left arm at 04:00 PM on 25Jan2021 for COVID-19 immunisation. Patient reported that she had been diagnosed with fibromyalgia and saw a rheumatologist that specializes in treating fibromyalgia. At 01:00 AM on 17Feb2021, fourteen hours later, she awoke to not being able to turn over in bed. Her hands, feet, toes and entire body, felt almost paralyzed. She could not bend her fingers or toes. Her muscles throughout her body remained stiff and tight for the next 16 hours. Chills, headache but no fever. Patient took paracetamol (TYLENOL) every four hours, during this time. It did not help with the tense muscle aches. Later on 17Feb2021 (that same day), approximately 19:00 (7:00 PM), her muscles started to relax. Patient was writing this the day after and she felt fine. She could hardly wait for the booster shot. Outcome of the events was recovered/resolved in Feb2021. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PVT,DESIPRAMINE; CYMBALTA; VIT D; ZINC,,Medical History/Concurrent Conditions: Fibromyalgia (in good health other than the fibromyalgia); Latex allergy; Pituitary microadenoma (52 years),,,"['Bedridden', 'Chills', 'Headache', 'Muscle tightness', 'Musculoskeletal stiffness', 'Myalgia', 'Paralysis']",2,PFIZER\BIONTECH, 1070732,NC,55.0,M,"had a feeling of impending death and thought he was gonna die.; Syncopal episode; My platelets counts drop; metallic taste; Potassium level went down; This is a spontaneous report from a contactable nurse (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) first dose on 12Feb2021 on Deltoid Left at single dose for covid-19 immunisation. Medical history included Covid-19 and High cholesterol. Concomitant medications were not reported. He said that he was 60 days post COVID and his doctor advised him to get vaccinated. He was feeling fine, but after 10 minutes into the shot, he had a metallic taste in the mouth. After 12-13 minutes, he had a feeling of impending death and thought he was gonna die. It freaked him out. He was rushed to the ER and had a complete blood count (CBC) and Basic Metabolic Panel (BMP) test run on him. It was that his Potassium level went down to 3.3 and his platelets dropped to 141. He had tests on 28Jan2021 and mentioned that his Potassium levels were normal and had a platelet count of 181. He mentioned that there was no other way but the vaccine that could have caused this. He is if he would already have passed away from the shot from his opinion. Patient had a Syncopal episode of some type. He had an intended feeling like he was going to die after the shot, he was 60 days post Covid when he get that shot, he was getting over Covid and he was 60 days and he didn't wait the 90 days his primary doctor care told me that he can get it too because he was feeling better which he was feeling better but since then he have gotten that shot, he went to the doctor on the 28Jan2021 and he had CBC drawn on him and he went for his regular physical and Covid follow-up at his doctor, his platelets counts drop since he have had shot struck at 40 points, feels concerning. The outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported ""feeling of impending death and Syncopal episode "" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/12/2021,0.0,PVT,,,Medical History/Concurrent Conditions: COVID-19; High cholesterol,,,"['Blood potassium', 'Blood potassium decreased', 'Dysgeusia', 'Full blood count', 'Metabolic function test', 'Near death experience', 'Platelet count', 'Platelet count decreased', 'Syncope']",1,PFIZER\BIONTECH, 1070733,NC,30.0,F,"miscarriage; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose on 08Jan2021 in right arm and 1st dose on 15Dec2020 in left arm, both via intramuscular at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient previously took amoxicillin and experienced allergy. Concomitant medication included prenatal vitamins. The patient experienced miscarriage on 11Jan2021 with outcome of recovered. The event resulted in doctor or other healthcare professional office/clinic visit. The mother reported she became pregnant while taking bnt162b2. The mother was 11 weeks pregnant at the onset of the event. The mother was due to deliver on 07Aug2021. Date of LMP was 26Oct2020. Therapeutic measures were taken as a result of miscarriage included misoprostol (CYTOTEC). Information of lot/batch number has been requested.; Sender's Comments: The limited information provided precludes a full clinical assessment of the case. Considering the product-event temporal relationship, a causal association between the reported 'miscarriage' and the administration of bnt162b2 cannot be completely excluded. Case will be reassessed once with additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/11/2021,3.0,PVT,,,,,,['Abortion spontaneous'],2,PFIZER\BIONTECH,OT 1070734,OH,100.0,F,"fall; This is a spontaneous report from a contactable consumer (patient's daughter). A 100-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9261) via an unspecified route of administration in left arm on 22Jan2021 at single dose for COVID-19 immunisation. There were no relevant medical history or concomitant medications (it was also reported that the patient was on a lot of different medications). The patient experienced fall on 16Feb2021. The patient was then ""hospitalized for a fall"" and might not be attend her second vaccination appointment. Her second dose was scheduled on 24Feb2021. The hospitalization had nothing to do with vaccine. The outcome of event was not recovered.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/22/2021,02/16/2021,25.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Fall'],1,PFIZER\BIONTECH, 1070735,MI,66.0,F,"I passed out going down stairs; woke up disoriented; weak; dizzy; bloody nose; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received her second single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine, lot number EM9810) at her left arm, at 11:00AM 17Feb2021, for Covid-19 immunization. The patient received her first injection (Lot number EL9765) on 27Jan2021 10:15AM at her left arm. The patient's medical history was not reported. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient was fine for 10 hours afterwards, went to bed, woke up disoriented weak and dizzy. She passed out going down stairs, came to on the floor at the bottom of the stairs, bloody nose, about an hour later passed out again in the kitchen and woke up on the floor. No warning either time, like light switch being turned off. The patient never had a reaction to anything before, never passed out before. She felt better at time of reporting. The adverse events happened at 07:00 AM 18Feb2021. The patient had not received any treatment for the events and not covered from the events. The patient had no Covid prior vaccination and Covid was not tested post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/18/2021,1.0,PVT,,,,,,"['Asthenia', 'Disorientation', 'Dizziness', 'Epistaxis', 'Loss of consciousness']",2,PFIZER\BIONTECH, 1070736,FL,79.0,F,"nearly fainting; Head ache; fatigue; upset stomach; vomiting; chills; new mouth sores; painful arm; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9365) via an unspecified route of administration in the right arm on 15Feb2021 12:00 AM at single dose for covid-19 immunisation. Medical history included allergy to bees and wasps. The patient was not pregnant at the time of vaccination. Concomitant medications included rosuvastatin and olmesartan medoxomil. The patient previously received first dose of BNT162B2 (lot number: EL1283) via an unspecified route of administration in the right arm on 21Jan2021 12:00 AM at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After receiving the second dose, the patient experienced headache, fatigue, upset stomach and nearly vomiting, chills, nearly fainting and new mouth sores, painful arm on 15Feb2021 13:15. No treatment was received for the adverse events. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Outcome of the events was recovered in Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,UNK,ROSUVASTATIN; OLMESARTAN MEDOXOMIL,,Medical History/Concurrent Conditions: Allergy to arthropod sting,,,"['Abdominal discomfort', 'Chills', 'Fatigue', 'Headache', 'Stomatitis', 'Syncope', 'Vaccination site pain', 'Vomiting']",2,PFIZER\BIONTECH, 1070737,AL,69.0,F,"became almost non-responsive/nearly totally nonresponsive; her blood sugar went down to 25; she was tired; This is a spontaneous report from a contactable consumer. A 69-year-old female patient (reporter's wife) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EN5318) on 12Feb2021 on right arm at a single dose for COVID-19 immunisation. Medical history included diabetes diagnosed about 30 years prior. Concomitant medications were none. Patient got the 1st dose of bnt162b2 and 4 hours after getting it, her blood sugar went down to 25 (12Feb2021) and she became almost non-responsive. She took a lot of carbohydrates after the shot before she plummeted. Reporter asked if there had been any reports of this and should she take the 2nd shot. Reporter said that he is reporting the side effect of that approximately 4 hours after receiving the shot, which his wife is diabetic, she was tired and then her sugar dropped to 25 before he realized she had an issue. He says she was nearly totally nonresponsive (12Feb2021). He said this was very abnormal and her sugar has never been that low. He said after he realized her sugar dropped to 25, he got some ice cream into her and then some (brand name withheld), then he got her blood sugar which the next reading was 47, then the third reading was mid 90s, so then he took her to the emergency room and they ran tests. He says by then her blood sugar was 250-280, which they thought was good after it had been that low. He says that they did blood tests and did not find anything abnormal, and her blood sugar has been good since then. He said she was not admitted to the hospital, and they went home that night. He said that this had never occurred before, period. Reporter said that everything seems to be normal at this point, though it scared them. He said his wife has not gotten the second dose yet, and they have questioned if she should take the second dose since this happened, and he was wondering if Pfizer may have advice to provide them on getting the second dose for her. The outcome of events was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Diabetes (Additional Information for Other Conditions: Caller says that it was diagnosed about 30 years ago.),,,"['Blood glucose', 'Blood glucose decreased', 'Fatigue', 'Investigation', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH, 1070738,SC,67.0,M,"feel like what I have is spreading from my sinuses to my chest (respiratory infection); nausea; loose stools; headache; chills; nasal drainage; sore throat; sinus congestion; hiccups lasting 2+days and still continuing; tiredness; minor soreness at the injection site; This is a spontaneous report from a contactable consumer report for self. A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration in left arm on 12Feb2021 12:15 at single dose for covid-19 immunisation. Medical history included Coronary artery disease requiring stenting, under the care of an Allergist for past 46 years. No Covid prior vaccination. No other vaccine in four weeks. Concomitant medications in two weeks include Atorvastatin Calcium, acetylsalicylic acid (ASPRIN), fexofenadine hydrochloride (ALLEGRA), Clopidogrel. An unspecified date in Feb2021 11:00 PM, patient experienced nausea, loose stools, headache, chills, nasal drainage, sore throat, sinus congestion, hiccups lasting 2+ days and still continuing, tiredness, minor soreness at the injection site but just for the first couple of days which was expected, feel like what have is spreading from sinuses to chest (respiratory infection) which concerns. The outcome of events was not recovered. Treatment not received. Covid Nasal Swab tested post vaccination on 19Feb2021, test result pending.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/01/2021,,UNK,ATORVASTATIN CALCIUM; ASPRIN; ALLEGRA; CLOPIDOGREL,,"Medical History/Concurrent Conditions: Coronary artery disease (requiring stenting, under the care of an Allergist for past 46 years)",,,"['Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Hiccups', 'Nasal disorder', 'Nausea', 'Oropharyngeal pain', 'Respiratory tract infection', 'SARS-CoV-2 test', 'Sinus congestion', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1070740,MN,,M,"developed pneumonia; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first Pfizer vaccine shot on 03Feb2021 and was due to receive 2nd dose on 24Feb2021. 2 weeks after receiving his 1st vaccine dose, patient developed pneumonia and is currently in the hospital. Patient was hospitalized. The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/03/2021,02/01/2021,,UNK,,,,,,['Pneumonia'],1,PFIZER\BIONTECH, 1070742,WV,66.0,F,"fell on the ice; broke hip, arm and her wrists; broke hip, arm and her wrists; broke hip, arm and her wrists; This is a spontaneous report from a contactable consumer report for self from a Pfizer Sponsored Program . This 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunization. None medical history nor other products. The patient received the first vaccine on the 03Feb and she is scheduled to get the second one on 24Feb and about a week after the first dose she fell on the ice at her house and broke hip, arm and her wrists and had to have surgery. Her admission into the hospital was 09Feb2021. She had surgery on the 10Feb. She was discharged home 13Feb2021. She lost enough blood in surgery that she had to have 2 units of blood transfusion, she said the blood transfusions on 11Feb2021. She wanted to know is it safe to get the second vaccine after having those transfusions.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,02/03/2021,02/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Fall', 'Hip fracture', 'Upper limb fracture', 'Wrist fracture']",1,PFIZER\BIONTECH, 1070743,FL,,M,"tested positive to COVID-19/wasn't feeling right, had a cold, stuffed nosed, throat was bad, and 3 days after he has soreness in his throat; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (reporting for son). A 54-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter's son (the patient) received the first dose of the Pfizer-BioNtech COVID-19 vaccine on an unknown date. Two (2) days later he wasn't feeling right, had a cold, stuffed nosed, throat was bad, and 3 days after he has soreness in his throat. About 8 days after the shot, he tested positive to COVID-19. He was asked to quarantine for 10 days and will have a second COVID-19 test then. His breathing was ok. He will probably have to wait 3 months for his second shot. The doctor told him it might be a false read. The event was reported as non-serious. The outcome of the event ""tested positive to COVID-19/wasn't feeling right, had a cold, stuffed nosed, throat was bad, and 3 days after he has soreness in his throat"" was uknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1070744,FL,95.0,M,"Hallucinations after both doses; This is a spontaneous report from a contactable consumer. A 95-year-old male patient received bnt162b2 (BNT162B2, lot number unknown), via an unspecified route of administration, first dose on 25Jan2021 10:00, second dose (Lot number=En6021) on 17Feb2021 12:30, both at Left arm, at single dose, for COVID-19 immunisation. Medical history included High cholesterol from an unknown date. No other vaccine in four weeks. There is other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies. The patient experienced hallucinations after both doses on 28Jan2021. On 28Jan2021, 3 days after first vaccine he began having hallucinations that lasted for two days. 19Feb2021, 2 days after second vaccine he began having hallucinations. This is being reported at the moment so the reporter cannot say what the end date will be. No treatment AE. The outcome of the event was recovered in Jan2021 for the first time . Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/28/2021,3.0,SEN,,,Medical History/Concurrent Conditions: High cholesterol,,,['Hallucination'],1,PFIZER\BIONTECH, 1070745,SC,70.0,F,"pain at injection site; swelling; warmth; redness; This is a spontaneous report from a contactable nurse. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EM9810) via intramuscular in the left arm on 10Feb2021 13:15 at single dose for covid-19 immunisation. Medical history included hypothyroid. Known- allergies included sulfamethoxazole; trimethoprim (BACTRIM). Concomitant medication included levothyroxine, tramadol, aluminium hydroxide gel, dried, magnesium carbonate (PEPCID). There was no other vaccine in four weeks. The patient had not COVID prior vaccination. The patient had not COVID tested post vaccination. The patient experienced pain at injection site, swelling, warmth, redness; all on 12Feb2021 08:00. The events resulted in physician office visit. The patient was hospitalized from Feb2021 for the events. Treatment received for the events included cefalexin (CEPHALEXIN) orally; methylprednisolone (MEDROL) dose pack; famotidine; and cetirizine hydrochloride (ZYRTEC). The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/10/2021,02/12/2021,2.0,PVT,"LEVOTHYROXINE; TRAMADOL; PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]",,Medical History/Concurrent Conditions: Hypothyroidism,,,"['Erythema', 'Feeling hot', 'Swelling', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 1070746,PA,36.0,M,"Tingling burning in all extremities, trunk and face; Tingling burning in all extremities, trunk and face; weakness in all extremities; Shortness of breath with after completing one flight of stair.; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for himself. A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included high blood pressure (BP), ocular migraine. Concomitant medication included amitriptyline, amlodipine. The patient received first dose of BNT162B2 on 02Jan2021 4:00PM for Covid-19 immunization and expedited tingling in right 15 days first dosage. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Tingling burning in all extremities, trunk and face after second dosage. Tingling and burning was followed by weakness in all extremities including Shortness of breath with after completing one flight of stair. Visited primary care physician and blood work results were not significant for any abnormalities. Visited emergency room (ER) and was seen by neurologist who did think symptoms were severe. Awaiting EMG scheduled for 24Mar2021. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect drug administration to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,,,WRK,AMITRIPTYLINE; AMLODIPINE,,Medical History/Concurrent Conditions: Blood pressure high; Ophthalmic migraine,,,"['Blood test', 'Burning sensation', 'Dyspnoea exertional', 'Muscular weakness', 'Paraesthesia']",2,PFIZER\BIONTECH, 1070747,FL,73.0,F,"severe cramps; mild headache; lower abdominal pain across lower abdomen; This is a spontaneous report received from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), on 15Feb2021 at 09:30 AM (at the age of 73-year-old) on left arm at single dose for COVID-19 immunization. It was reported that patient was not pregnant at the time of event and at the time of vaccination. The patient's medical history was reported as none including no known allergies and no covid prior vaccination. The patient's concomitant medications included simvastatin (ZOCOR). The patient previously received the first dose of BNT162B2 (lot number EL1283), on 25Jan2021 09:30 AM (at the age of 73-year-old) on left arm for COVID-19 immunization, no other vaccines were administered in four weeks prior to vaccination. On 16Feb2021 at 10:00 AM the patient experienced mild headache severe cramps and lower abdominal pain across lower abdomen. The event ""severe cramps"" was reported as serious with criteria medically significant while the other events were reported as non-serious. No treatment for the events was received. No covid test was performed post vaccination. The outcome of the events was not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/16/2021,1.0,PUB,ZOCOR,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none, Comment: including no known allergies and no covid prior vaccination",,,"['Abdominal pain', 'Abdominal pain lower', 'Headache']",2,PFIZER\BIONTECH, 1070749,FL,69.0,F,"Stuffy nose; Chills; Strong heartbeat; Severe diarrhea; Headache; This is a spontaneous report from a contactable consumer. The consumer reported for herself that the 69-years-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Lot number: EL9262) via an unspecified route of administration on 17Feb2021 13:00 on Left arm at single dose for covid-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing. Concomitant medication included simvastatin, ropinirol [ropinirole] (ROPINIROL [ROPINIROLE]), vitamin d3 (VITAMIN D3). The patient previously took first dose of bnt162b2 (COVID 19 Pfizer Bio Tech) on 27Jan2021 01:15 PM on Left arm for covid-19 immunisation, montelukast and experienced drug hypersensitivity. The patient experienced stuffy nose, chills, strong heartbeat, severe diarrhea, headache all on 18Feb2021 01:15AM with outcome of recovered. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. The event was assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/18/2021,1.0,UNK,SIMVASTATIN; ROPINIROL [ROPINIROLE]; VITAMIN D3,,Medical History/Concurrent Conditions: Breast cancer,,,"['Chills', 'Diarrhoea', 'Headache', 'Nasal congestion', 'Palpitations']",2,PFIZER\BIONTECH, 1070750,OR,44.0,F,"very high Troponin levels (4.79 & 12.49); repeat episodes of chest pain; heart attack; thrombus formation; coagulopathy; myocardial infarction; This is a spontaneous report from a contactable nurse (reporting for herself). A 44-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# ELI283), via an unspecified route of administration single dose on 12Jan2021 for covid-19 immunisation. First dose was received on 22Dec2020 10:00 left arm (lot# EJI695). Medical history included chronic skin condition. No other vaccine was received in four weeks. Concomitant medications included oxycodone for pain, colecalciferol (VITAMIN D). The patient experienced myocardial infarction on 10Feb2021 20:00, very high troponin levels (4.79 & 12.49) on 11Feb2021, repeat episodes of chest pain on 10Feb2021 20:00, heart attack on 10Feb2021 20:00, thrombus formation on 10Feb2021 20:00, coagulopathy on 10Feb2021 20:00. The patient was hospitalized due to the events from 11Feb2021. Patient reported to be a healthy 44 year old woman with no history of hypertension or high cholesterol. She was now on 7 different medications to protect her heart, including blood thinners and antihypertensives that result in daily headaches and fatigue. She had had several repeat episodes of chest pain which has required taking sublingual nitroglycerin. She was off work for an undetermined amount of time. Her primary care physician was baffled by her case and reached out to a number of experts who have agreed that her heart attack was caused by a thrombus formation/coagulopathy most definitely related to the Covid vaccines she received. The events outcome was recovered with sequelae.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of myocardial infarction and other events. However, the reported events may possibly represent intercurrent medical conditions in this 44-years-old patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, electrolytes, chemistry panel and coronary angiogram, and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,1.0,Yes,N,01/12/2021,02/10/2021,29.0,WRK,OXYCODONE; VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: Hidradenitis suppurativa (Chronic skin condition (hidradenitis suppurativa)),,,"['Chest pain', 'Coagulopathy', 'Myocardial infarction', 'Thrombosis', 'Troponin', 'Troponin increased']",2,PFIZER\BIONTECH, 1070751,,,M,"grand mal seizure; pain in the muscle where the injection was given (sore arm); body aches; fatigue; memory loss; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A male patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Feb2021, in arm, for COVID-19 immunisation. The patient was a cancer patient who was taking chemotherapy. On 20Feb2021 the patient experienced grand mal seizure and was hospitalized on the same day. On an unspecified date in Feb2021 the patient also experienced pain in the muscle where the injection was given (sore arm), body aches, fatigue and memory loss. The patient had never had a seizure before and has had memory loss with these seizures as well (had another one in the hospital very early on 22Feb2021 morning). Events outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Grand mal seizure cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/16/2021,02/01/2021,,UNK,,Chemotherapy,Medical History/Concurrent Conditions: Cancer (was taking chemotherapy),,,"['Amnesia', 'Fatigue', 'Generalised tonic-clonic seizure', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 1070752,MI,,F,"passed out several times; vertigo/dizzy; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program. A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 12Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient received the second dose on 12Feb2021 and woke up yesterday (15Feb2021) dizzy and passed out several times. The Dr diagnosed her with vertigo and gave medication for that (medication not named). The patient wanted to know if Pfizer COVID vaccine is linked with vertigo or not. This is her third time being transferred, she was clearly not feeling greatest and she has been on the phone for almost 30 minutes. The outcome of the events was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/15/2021,3.0,UNK,,,,,,"['Loss of consciousness', 'Vertigo']",2,PFIZER\BIONTECH, 1070754,NY,,F,"Severe allergic reaction; Itching in the mouth and the throat; Itching in the mouth and the throat; Coughing; she lost her voice/She became unable to speak; Her face get dark; This is a spontaneous report from a contactable consumer (mother). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history included hypertension, diabetes mellitus and renal failure from 17Feb2020 to an unknown date; dialysis from 04Dec2020 to an unknown date and kidney transplant on 12Aug2004. The patient's concomitant medications were not reported. Reporter stated, ""I am calling for a patient, patient can't speak right now. She had a very severe allergic reaction to the Pfizer vaccine. I am her mother. I just wanted to be on the right page. I am calling because I called the vaccine advocate system because my daughter took the Pfizer vaccine on the 17th and after the Pfizer vaccine, the first dose, she had underlying issues. She started coughing, she lost her voice. She became unable to speak. It began between 4-5 minutes after the vaccine. I have the number of Pfizer Vaccine that she took. She took the vaccine and because of the underlying issue of renal failure as she almost died, her face got black, I would have never thought that my child could have died of the shot. She is renal person. Lab work: ""Yes, she had because of her kidney problem, they did a blood work, for this problem she was admitted to the hospital for observation on the 17th, for day or two ago at (hospital name). They did ECG, chest X-ray, blood work, endo test to make sure that respiratory area was not swollen or anything. The medication was given for that."" Treatment: ""Solu-Medrol, Albuterol, to open respiratory area, Pepcid, Benadryl, IV Cetirizine."" Reporter then stated, ""My problem is right now, after the vaccine the observation which was started within 4-5 minutes. She spoke with me before the vaccine and after the vaccine. She called and I don't know who was on the phone. I said who is this? Save me, she said I can't speak. It is sounding like people making love funny jokes to you as she was coughing and terribly itching in the mouth and the throat. Her face get dark, she got very nervous because of course something's going over you. She is 45, young person. So right now why I am calling because she can't speak on the phone, she cannot speak. She is speaking the same way. All what they did to her, they gift to her, she cannot speak. Because was in the hospital. She had to be admitted in hospital for observation. Her vitals all came normal, her blood work and everything was normal. So, they discharged her with the medications here, Prednisone 40mg. So, that would ever help to combat the allergy? So, I am very concerned about her speaking because tomorrow will make it 4 days. Pfizer has to know this. Because of the underlying issue. They have to be very careful. Is somebody is going to get back to me? Yes or no? Or what happens?"" The patient underwent lab tests and procedures which included chest x-ray and electrocardiogram: unknown and blood work: everything was normal on an unspecified date. Therapeutic measures were taken as a result of coughing, she lost her voice/she became unable to speak and itching in the mouth and the throat. The outcome of the events was unknown.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,Kidney transplant,Medical History/Concurrent Conditions: Diabetes (Verbatim: Diabetes); Dialysis (Verbatim: Dialysis); Hypertension (Verbatim: Hypertension); Renal failure (kidney problem),,,"['Aphonia', 'Blood test', 'Chest X-ray', 'Cough', 'Electrocardiogram', 'Hypersensitivity', 'Oral pruritus', 'Skin discolouration', 'Throat irritation']",1,PFIZER\BIONTECH, 1070755,MA,51.0,M,"Chills; Sweating; Headaches; Muscle aches; Pains; This is a spontaneous report from a contactable consumer (patient himself). A 51-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot# EL3247), via an unspecified route of administration on 16Feb2021 10:00 in right arm at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication within 2 weeks of vaccination included venlafaxine hydrochloride (EFFEXOR XR), amlodipine besilate (NORVASC), atorvastatin (LIPITOR). The patient previously took the first dose of bnt162b2 (PFIZER, lot# EL3247) on 27Jan2021 13:00 in right arm for covid-19 immunization. The patient previously took sulfur and experienced allergies: sulfur. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced chills, sweating, headaches, muscle aches and pains on 16Feb2021 16:00. No treatment was received for events. This case was reported as non-serious. Outcome of events were recovered in Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,WRK,EFFEXOR XR; NORVASC; LIPITOR [ATORVASTATIN],,,,,"['Chills', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Pain']",2,PFIZER\BIONTECH, 1070756,CO,68.0,F,"severe stomach flu like symptoms; protracted vomiting; nausea; abdominal cramping; muscle aches; injection site reaction; This is a spontaneous report from a contactable other hcp (patient). This 68-year-old female patient (pregnant no) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number En6200), via an unspecified route of administration on 20Feb2021 10:30 AM on left arm at single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medication included rosuvastatin and hydrochlorothiazide/losartan. The patient experienced injection site reaction and severe stomach flu like symptoms, nausea, protracted vomiting, abdominal cramping and muscle aches on 20Feb2021 19:00. The patient had not received other vaccine in four weeks. There was no treatment received, no COVID prior vaccination and no COVID tested post vaccination, no known allergies. The outcome of the events was recovering.; Sender's Comments: Drug causality for suspect drug BNT162B2 in the onset of the reported events cannot be excluded . The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,PVT,ROSUVASTATIN; HYDROCHLOROTHIAZIDE;LOSARTAN,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Abdominal pain', 'Gastroenteritis viral', 'Myalgia', 'Nausea', 'Vaccination site reaction', 'Vomiting']",1,PFIZER\BIONTECH, 1070757,CA,,F,"massive heart attack; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on Feb2021 (at an unspecified age) as a single dose for COVID-19 immunization. Medical history included a pacemaker and a heart condition. On Feb2021 (two days after the vaccination), she was rushed to the hospital by ambulance thinking she had a massive heart attack. The patient was hospitalized for two and a half days in Feb2021. The clinical outcome of massive heart attack was unknown. Information on Lot /Batch Number has been requested.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Artificial cardiac pacemaker user; Heart disorder,,,['Myocardial infarction'],1,PFIZER\BIONTECH, 1070758,NC,75.0,F,"has lupus and a couple days ago, she started having inflammation pain; has lupus and a couple days ago, she started having inflammation pain; Fever; Achy; Pleuritic pain; Shortness of breath; O2 level was a little lower it was in the low 90's and she usually runs 96 to 97; This is a spontaneous report from a contactable consumer reporting for herself. A 75-years-old female patient received the second dose of bnt162b2 (BNT162B2)vaccine , intramuscular in the right arm on 08Feb2021 15:30 at single dose for covid-19 immunisation . Medical history included systemic lupus erythematosus , asthma, thyroidectomy . The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 vaccine on 18Jan2021. The patient has lupus and a couple days ago, she started having inflammation pain on 14Feb2021 with outcome of unknown, O2 level was a little lower it was in the low 90's and she usually runs 96 to 97 on Feb2021 with outcome of unknown , fever on 09Feb2021 with outcome of unknown , achy on 09Feb2021 with outcome of unknown , pleuritic pain on Feb2021 with outcome of recovering , shortness of breath on Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included oxygen saturation: low 90's. The second day, she had a little bit of a fever and was achy. She has lupus and a couple days ago, she started having inflammation pain. It has progressed and went to pleurisy pain. She has really been down for the count. She has had problems breathing with the pleurisy pain, but she has had no fever. She has had a little shortness of breath. She has a pusle oximetry and her O2 level was a little lower, it was in the low 90's and she usually runs 96 to 97.The patient has taken Tylenol and the pleurisy pain is better. She can breathe without pain. The patient is wondering if the vaccine causes problems or after affects for more than a week sometimes or if this is just plain lupus causing issues. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Asthma; Lupus erythematosus; Thyroidectomy,,,"['Dyspnoea', 'Inflammatory pain', 'Oxygen saturation', 'Oxygen saturation decreased', 'Pain', 'Pleuritic pain', 'Pyrexia', 'Systemic lupus erythematosus']",2,PFIZER\BIONTECH,OT 1070759,FL,68.0,M,"Something like a mini stroke occur; some kind of injury to his neck; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored program Covax US Support. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9263), via an unknown route of administration on 27Jan2021 (at the age of 68-years-old) as a single dose for Covid-19 immunization. Medical history included a heart patient prior to the vaccine for which he takes heart medications from an unknown date. The patient's concomitant medications were reported as a lot of medications and heart medications for which he has been taking for years (unspecified). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Feb2021 at 16:00, the patient experienced something like a mini stroke; and he had some kind of injury to his neck from an unknown date. The patient was hospitalized due to heart problems describes as mini stroke on 15Feb2021. The patient underwent lots of test (unspecified) on an unknown date with unknown results. The clinical outcome of the event mini stroke and neck injury was unknown. The patient was still hospitalized.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/27/2021,02/15/2021,19.0,UNK,,,"Medical History/Concurrent Conditions: Heart disease, unspecified (takes heart medications.)",,,"['Cerebrovascular accident', 'Investigation', 'Neck injury']",1,PFIZER\BIONTECH, 1070760,SC,79.0,F,"Lost part of my vision and it only lasted for three to four minutes; mini stroke/ TIA; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2(Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9284, Expiration date: 31May2021), via an unspecified route of administration at the left arm on 11Feb2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 11Feb2021 7pm, patient went to get something to open the can of soup but when she went into the pantry, she lost part of her vision and it only lasted for three to four minutes. The patient's daughter who is a neurologist thought it was the mini stroke or TIA (Feb2021). The doctor was setting up the sonogram for her arteries and her neck and also for her heart and said she might have to rely on a pacemaker. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/01/2021,,UNK,,,,,,"['Blindness transient', 'Transient ischaemic attack']",UNK,PFIZER\BIONTECH, 1070761,FL,,M,"A very ""mild"" stroke/heart attack; A very ""mild"" stroke/heart attack; This is a spontaneous report from a contactable consumer. A male elderly patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported at the time of the report), via an unspecified route of administration from an unspecified date at SINGLE DOSE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that: ""I'm working on a story involving an elderly man whose family says he suffered a very ""mild"" stroke/heart attack about 4 days after getting the first dose of the Pfizer vaccine. The family says it took doctors a couple of days to confirm. They also said none of the doctors could say definitively that the vaccine had anything to do with what happened. The family says they still called the company to report it and have since received follow-up contact. While they were worried about him getting the second dose, they decided to proceed with that. He got the dose last week and the family says he's been fine. I wanted to reach out and see if you had a statement you'd like to provide. Also -Are strokes/heart attacks side effects of the Pfizer vaccine? If someone suffered a stroke or heart attack after getting the first shot and they believe it's related to the vaccine, should they get the second dose? "" The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Cerebrovascular accident', 'Myocardial infarction']",1,PFIZER\BIONTECH, 1070762,AZ,45.0,F,"severe abdominal pain; low grade fever; body chills; had an appendectomy at the ER; This is a spontaneous report from a contactable consumer (patient). This 45-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EN5318), via an unspecified route of administration on 11Feb2021 15:00 at single dose in the right arm for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included magnesium, cannabidiol (CBD) and docusate sodium (COLACE) received within 2 weeks of vaccination. The patient previously took the first dose of bnt162b2 (lot number=EL1283) on 21Jan2021 15:00 in the left arm for COVID-19 immunization and experienced extreme muscle cramps in both legs. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. On 13Feb2021 19:00, patient experienced severe abdominal pain with a low grade fever and body chills. Patient visited her primary doctor the following day, and then went to the ER on day four of the onset of her symptoms. Patient had an appendectomy in Feb2021 at the ER. The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse event included surgery to remove appendix. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab (post vaccination): Negative on 15Feb2021 and 16Feb2021. Outcome of the events was recovering. The report was assessed as serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021183649 same patient, different AE/dose",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/01/2021,,UNK,MAGNESIUM; CBD; COLACE,,,,,"['Abdominal pain', 'Appendicitis', 'Chills', 'Pyrexia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1070763,CA,66.0,F,"large knot right above the injection site/size of a half dollar/size of a silver dollar and where the needle went in was right at the base of that knot/like egg under the skin or clot; felt like she got a flu shot and could tell her arm was very sore; swelling started almost immediately after the shot/swelling was exactly underneath the injection site, just in the pronounced area/about 4 inches wide and about 2 inches high; thought maybe someone has hit a vein because it did bleed and ran down her arm; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EN6201, unknown expiration), via an unspecified route of administration on 18Feb2021 at 04:30 at a single dose for COVID-19 immunization. Medical history reported as none. Concomitant medications included tolterodine and adalimumab (HUMIRA). The patient reported that she received the COVID vaccine on 18Feb2021 at around 4:30. Firstly it was fine, she felt like she got a flu shot and could tell her arm was very sore. What concerned her was the swelling started almost immediately after the shot on 18Feb2021. She knew that was one of the symptoms. This morning and yesterday though (18Feb2021), she noticed some of the symptoms. She got a large knot that was right above the injection site. Yesterday, it was about the size of a half dollar, today it is about the size of a silver dollar and where the needle went in was right at the base of that knot. It feels like an egg under the skin or a clot. Like a knot (a hard spot underneath the skin). The patient was wondering if it was something she should be concerned about because the swelling was exactly underneath the injection site, just in the pronounced area. It was a rectangle and is about 4 inches wide and about 2 inches high and then right above that was where the needle went in. The large circle or knot was right above that and she was thinking possibly when she was given the injection she has never really bleed before. So, she thought maybe someone has hit a vein because it did bleed and ran down her arm. She got no problem. That happens at times, but she started thinking if this was a clot or it was something that is right above there because it is so pronounced, and it really hurts. The patient stated that she took some Aspirin last night and is going to take an ibuprofen in a little while. She mentioned that she takes this one pill and it has nothing to do with anything. The patient had lab work done (unknown results) that was about 3 weeks ago (2021). She also stated that she also take Humira which is a shot every 2 weeks and it said in the fact sheet that she should be concerned or be sure that she did not take any medicine that affects the immune system and Humira does weaken the immune system but she was not ask that prior to. The patient wanted to know if is that something she should be concerned about. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/18/2021,0.0,UNK,TOLTERODINE; HUMIRA,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Laboratory test', 'Thrombosis', 'Vaccination site haemorrhage', 'Vaccination site pain', 'Vaccination site swelling']",UNK,PFIZER\BIONTECH, 1070764,,61.0,M,"had total paralysis of the left side of his face; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration at arm left on 20Feb2021 11:00 AM at the age of 61-year-old at single dose for COVID-19 immunisation. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration at left arm on 30Jan2021 11:00 AM at the age of 61-year-old for COVID-19 immunisation. Patient had no COVID-19 prior vaccination. COVID-19 was not tested post vaccination. There was no known allergies. Other relevant medical history was reported as none. Concomitant medications were not reported. There was no other vaccine in four weeks. Patient had total paralysis of the left side of his face on 22Feb2021 at 07:00 AM. It was reported that the event resulted in disability or permanent damage. Outcome of the event was not recovered. No treatment for the event was received. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/20/2021,02/22/2021,2.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Facial paralysis'],2,PFIZER\BIONTECH, 1070765,,,M,"died 2 days after the second vaccine; This is a spontaneous report from a contactable consumer reporting for his/her father. An 87-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation and was fine. The patient died 2 days after the second vaccine. The reporter stated patient death due to the Pfizer Covid vaccine. The patient had autopsy. The outcome of event was fatal. Information about lot/batch number has been requested.; Reported Cause(s) of Death: died 2 days after the second vaccine",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],2,PFIZER\BIONTECH, 1070766,CA,90.0,F,"Difficulty breathing; Low blood pressure; This is a spontaneous report from a contactable consumer (patient). This 90-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201) via an unspecified route of administration in the right arm on 25Feb2021 at single dose for COVID-19. Medical history included Known allergies: Sulfa drugs, Afib, Diabetes, Meniere disease. The patient had COVID prior vaccination. Concomitant medications included amlodipine, celecoxib (CELEB), metformin, pravastatin, warfarin. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318) in the left arm on 04Feb2021 12:00 PM for COVID-19. The patient experienced difficulty breathing, low blood pressure on 26Feb2021 02:30 AM. The patient was admitted to Hospital. Life support IV in neck to maintain blood pressure. Treatment including high flow oxygen, life support IV to maintain BP was received for events. AE resulted in: emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient had no COVID tested post vaccination. Outcome of the events was unknown.",Not Reported,,Yes,Yes,,Not Reported,U,02/25/2021,02/26/2021,1.0,UNK,AMLODIPINE; CELEB; METFORMIN; PRAVASTATIN; WARFARIN,,Medical History/Concurrent Conditions: AFib; COVID-19; Diabetes; Meniere's disease; Sulfonamide allergy,,,"['Blood pressure measurement', 'Dyspnoea', 'Hypotension']",2,PFIZER\BIONTECH, 1070767,LA,70.0,F,"First injection: 1 hour after injection, pain in left knee and down to ankle. Felt as though metal rod was through knee; knee arthritic; This is a spontaneous report from a contactable consumer (patient) reported for self. A 70-year-old female patient (no pregnant) received her first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EM), via an unspecified route of administration at left arm at the age of 70-year-old, on 15Jan2021 11:30 at single dose for covid-19 immunisation. Medical history included bulging discs and allergies to penicillin. Concomitant medication included ascorbic acid (Vitamin C), colecalciferol (VITAMIN D), calcium, magnesium, biotin, curcuma longa (TURMERIC). The patient previously took hydromorphone hydrochloride (DILAUDID) and experienced allergies, sulphur and experienced allergies. One hour after first injection in left arm (15Jan2021 12:30 P.M), pain in left knee and down to ankle. Felt as though metal rod was through knee. Wore compression socks and a knee brace and did RICE to ease discomfort. At this report (2021) the patient felt knee arthritic since vaccine although intense pain subsided. No other vaccine received in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The adverse events resulted in disability. The outcome of events was recovered with lasting effects. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/15/2021,01/15/2021,0.0,PVT,VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; CALCIUM; MAGNESIUM; BIOTIN; TURMERIC [CURCUMA LONGA],,Medical History/Concurrent Conditions: Intervertebral disc bulging; Penicillin allergy,,,"['Arthralgia', 'Arthritis']",1,PFIZER\BIONTECH, 1070768,CA,37.0,F,"acute and severe shortness of breath; typical flu-like symptoms (fever 101.5, chills/shivering, body pain, headache, nausea); lost 10lbs; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in the left arm on 08Jan2021, at 08:30 as the second single dose for COVID-19 immunization. Medical history included past history of migraines and colitis from unknown dates. The patient's concomitant medications were not reported. The patient previously took erythromycin and experienced allergy; the patient also has a vaccination history of BNT162B2 (lot number: EJ1685) as first dose on 18Dec2020 for COVID-19 immunization. On 08Jan2021, at 20:00, the patient experienced acute and severe shortness of breath, typical flu-like symptoms (elaborated as fever 101.5, chills/shivering, body pain, headache, nausea), and lost 10lbs. The events were reported as life-threatening, elaborated by the reporting nurse as have been ""essentially incapacitated for six weeks"". The patient underwent lab tests and procedures which included body temperature: 101.5 on 08Jan2021, Nasal Swab: negative on 12Jan2021, weight: lost 10lbs on an unspecified date. Clinical course was as follows: patient noted that it felt as though she was having intractable diaphragm spasms that were forcing her exhales out at the end of her breath cycle. She lost 10lbs and was essentially incapacitated for 6 six weeks. The patient has been evaluated by head and neck , with no noted vocal cord dysfunction, speech pathology (no swallowing difficulties were noted), pulmonology (no lung specific issues were noted) and was awaiting a neurology consult. Therapeutic measures were taken as a result of the events, and included unspecified treatments in the emergency department described as lots of medications. There was no COVID infection prior to vaccination, and the patient has been tested post the vaccination, with negative results as aforementioned. The clinical outcome of typical flu-like symptoms (fever 101.5, chills/shivering, body pain, headache, nausea) was recovered in Jan2021; the clinical outcome of acute and severe shortness of breath and lost 10lbs was not recovered.; Sender's Comments: Based on event-vaccine chronological association, a causal relationship between events severe shortness of breath and typical flu-like symptoms and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely excluded. the event lost weight is attributed to an intercurrent medical condition and assessed unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,SEN,,,"Medical History/Concurrent Conditions: Colitis (other medical history: past history of migraines, colitis); Migraine (other medical history: past history of migraines, colitis)",,,"['Body temperature', 'Dyspnoea', 'Influenza like illness', 'SARS-CoV-2 test', 'Weight', 'Weight decreased']",2,PFIZER\BIONTECH, 1070769,,,F,"then died within 24 hours afterwards; This is a spontaneous report from a contactable consumer. This consumer reported that a 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration an unspecified date at single dose for COVID-19 immunization. Concomitant medications were not reported. The patient with a host of health issues (heart issues/had a pace maker, diabetes, among others) was in a rehabilitation center following a hospital stay and was given the second dose of vaccine. It was reported that the patient died within 24 hours afterwards. It was not reported if an autopsy was performed. Information on batch/lot number was requested.; Reported Cause(s) of Death: then died within 24 hours afterwards",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: Diabetes; Heart disorder; Hospitalization; Pacemaker insertion (cardiac),,,['Death'],2,PFIZER\BIONTECH, 1070770,TX,,U,"Maternal exposure during pregnancy; Fetus stopped growing on 09Feb21 (8w4d); no heartbeat detected; This is a spontaneous report from a contactable consumer (parent). This consumer reported information for both mother and fetus. This is a fetus report. A patient of unspecified age and gender (fetus) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), transplacental on 04Feb2021 at 14:00 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included ergocalciferol (VIT D), folic acid (FOLATE), ascorbic acid/betacarotene/calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/ nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide (PRENATAL VITAMINS) and sertraline hydrochloride (ZOLOFT) at 25 mg, all transplacental. It was reported that OB exam on 03Feb21 showed healthy baby at 7weeks 5days heartbeat detected 152 bpm; no abnormalities identified via ultrasound; labs and hormone levels all within normal ranges. No issues detected. Mother received 1st dose of vaccine on 04Feb2021. Per ultrasound on 20Feb2021, fetus stopped growing on 09Feb2021 (8 weeks 4 days); no heartbeat detected. Miscarriage occurred on 22Feb2021. The fetus died on 22Feb2021. It was not reported if an autopsy was performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021204433 same drug and reporter, different patient and event; Reported Cause(s) of Death: Fetus stopped growing on 09Feb21 (8w4d); no heartbeat detected; Mother received 1st dose of vaccine 04Feb21. Per ultrasound on 20Feb21, fetus stopped growing on 09Feb21 (8w4d); no heartbeat detected. Miscarriage occurred 22Feb21.",Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/01/2021,,PUB,VIT D; FOLATE; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; ZOLOFT,,,,,"['Foetal heart rate abnormal', 'Heart rate', 'Maternal exposure during pregnancy', 'Ultrasound scan']",1,PFIZER\BIONTECH,OT 1070802,WA,56.0,F,"On February 8th, 2021 patient came home early from work around noon due to not feeling well. She was feeling tired, slightly nauseous and very low energy. At about 4:50 PM that day, patient got up to walk to the pantry after eating some peanut butter toast. She suddenly stopped and shut her eyes and froze and then she began having a seizure (and she has never had a seizure before and seizures do not run in her family). After the shaking from the seizure ceased, her body tensed up and she fell flat backwards and she hit her head on the refrigerator. She then was going in and out of consciousness, she had a big laceration on her forehead and was bleeding rapidly. I, her daughter, witnessed this and then at 4:54 PM I called emergency services and paramedics arrived and took her to the hospital. Later that evening, the family was notified that the patient had bleeding in her brain, a concussion, a forehead laceration that received 15 stitches and a broken neck (C2 fracture). She was taken to the hospital that evening on February 8, 2021. Patuent experienced a second seizure while at the hospital during a CT scan. Patient later was able to come home February 11, 2021 in the afternoon. Patient now has to wear a neck brace for up to 12 weeks, cannot drive, cannot work for up to 12 weeks, and is still recovering cognitively from the concussion.",Not Reported,,Yes,Yes,3.0,Not Reported,N,02/07/2021,02/08/2021,1.0,PVT,"Buproprion XL (1 tablet 150 MG and 1 tablet 300 MG, both taken daily) and Venlafaxine ER 150 MG 1 tablet taken daily, fish oil, biotin, vitamin D, vitamin C, turmeric",None,Depression,,None,"['Asthenia', 'Cerebral haemorrhage', 'Cervical vertebral fracture', 'Computerised tomogram head abnormal', 'Concussion', 'Consciousness fluctuating', 'Craniocerebral injury', 'Fall', 'Fatigue', 'Haemorrhage', 'Head injury', 'Impaired driving ability', 'Impaired work ability', 'Malaise', 'Nausea', 'Seizure', 'Skin laceration', 'Subarachnoid haemorrhage', 'Suture insertion', 'Tension']",2,MODERNA,SYR 1070813,CO,42.0,F,"anaphylaxis - throat tightness, hoarseness, coughing, trouble swallowing, nausea, dizziness, pallor, watery eyes, urinary incontinence, sense of impending doom",Not Reported,,Yes,Not Reported,,Not Reported,Y,03/02/2021,03/02/2021,0.0,PVT,"Synthroid, Cytomel, Zoloft, Wellbutrin, Prilosec, Vitamin D3",post COVID,"previous anaphylaxis reaction to foods, low thyroid, obesity, depression",,"Tree nuts, coconut, citrus, melons, weed and grasses, cats, feathers, sulfite and adhesive sensitivity","['Anaphylactic reaction', 'Anxiety', 'Cough', 'Dizziness', 'Dysphagia', 'Dysphonia', 'Lacrimation increased', 'Nausea', 'Pallor', 'Throat tightness', 'Urinary incontinence']",UNK,MODERNA,IM 1070857,MO,83.0,F,"coughing white mucus 3 days after vaccine, fatigue day 1, shortness of breath on 2/24, 2/26 severe shortness of breath, admitted to er on 2/26",Not Reported,,Not Reported,Yes,,Not Reported,N,02/13/2021,02/16/2021,3.0,PVT,"prilosec, vitamin d, calcium, Tylenol arthritis, prednisone 5mg,","copd, lung cancer","copd, lung cancer",,"adhesive, sulfa","['Aspiration pleural cavity', 'Chest X-ray', 'Computerised tomogram', 'Dyspnoea', 'Fatigue', 'Laboratory test', 'Productive cough', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,IM 1070877,CA,66.0,F,"Had episode on 2/24/21 �of altered mental state, was w husband and he noted this.Said bizarre things. �Has no memory of this, lapsed recall for about 8 minutes. Has never had a similar episode. No hx of psychosis, bipolar or major mental illness of any kind, When returned to alert/aware �mental state, was terrified and crying. No stressors, says has stable life, no violence or threats. Seen in ER 2/24/21, but no brain imaging or EEG. Clarifies that dizziness and HA went on for several days, beginning same day 2/19 after got 2nd dose Covid vaccine, but the confusion/altered mental state was only for about 8 minutes. on 2/24. Still dizzy/HA/fatigue and some SOB as of 3/2/21. No fall or head trauma.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/19/2021,02/19/2021,0.0,OTH,"raniditine, naproxen, acetaminophen , ketotifen eye drops",none,"OSA, GERD, past episode BPV, prediabetes, hyperlipidemia, low back pain",,none known,"['Abnormal behaviour', 'Amnesia', 'Chest X-ray normal', 'Confusional state', 'Crying', 'Differential white blood cell count normal', 'Dizziness', 'Dyspnoea', 'Electrocardiogram normal', 'Fatigue', 'Fear', 'Full blood count normal', 'Headache', 'Hepatitis C antibody negative', 'Lipase normal', 'Mental status changes', 'Metabolic function test normal', 'Troponin I normal']",2,MODERNA,IM 1070883,IA,34.0,M,"15 minutes after vaccine, c/o scratchy throat. RN on site gave benadryl 25mg. BP 134/84, o2sat 98, pulse 90. Lungs clear, no wheezing. No hives. Monitored an hour and 15 minutes. No change in throat, no difficulty swallowing. Released to home, instructed if change in symptoms or develops hives or respiratory symptoms to call 911.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/03/2021,03/03/2021,0.0,OTH,No,No,Untreated hypertension,,Iodine,['Throat irritation'],1,JANSSEN,IM 1070885,NJ,33.0,F,"The individual felt neck, back and shoulder pain. Symptoms started 1-18-2021. On 1-31-21 she went to hospital and was admitted on 2-1-21 with nausea, chilss, headaches, vomiting, and body aches. COVID-19 test was reportedly negative. All tests were normal.",Not Reported,,Not Reported,Yes,,Not Reported,,01/17/2021,01/01/2021,,WRK,,,,,,"['Arthralgia', 'Back pain', 'Chills', 'Headache', 'Nausea', 'Neck pain', 'Pain', 'SARS-CoV-2 test negative', 'Vomiting']",UNK,PFIZER\BIONTECH, 1070896,CA,19.0,F,"One hour after vaccination, she experienced itchy throat, facial flushing, tongue swelling, respiratory distress, and abdominal pain and cramping. Patient self-administered epinephrine injection 0.3 mg in the car on the way home. Administered a second dose at home 45 minutes later. Then went to Hospital ER. she was given injections of benadryl and phenergan. observed and released.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/26/2021,02/26/2021,0.0,OTH,"baclofen, cromolyn, aimovig, botox, ferrous sulfate, magnesium, prochlorperazine, promethazine, norethindrone, triamcinolone, betamethasone dipropionate augmented, epinephrine, albuterol, almotriptan, tretinoin, buspirone, diazepam, ondanse",none,"Mast cell activation syndrome, Ehlers-Danlos syndrome, Chronic urticarial, IBS (irritable bowel syndrome), Migraine, Endometriosis, Patellar dislocation, initial encounter, bilat (left knee surgery 2019); POTS (postural orthostatic tachycardia syndrome); MDD (major depressive disorder), recurrent, in partial remission; GAD (generalized anxiety disorder); Osteochondritis dissecans of ankle, left; Overweight; Gastroesophageal reflux disease; Positive ANA (Homogeneous 1:640 ; Speckled 1:640); Lactose intolerance; Factor V Leiden mutation; Allergic rhinitis; Allergy to tree nuts",,"pecan, walnut, hazelnut. Also has contact dermatitis with adhesive tape.","['Abdominal pain', 'Flushing', 'Muscle spasms', 'Respiratory distress', 'Swollen tongue', 'Throat irritation']",1,PFIZER\BIONTECH,IM 1070903,IL,40.0,F,Syncope times 5 at home starting at 630 am. Called 911. Syncope 2 times at hospital. Hospitalized 2 days until it subsided. Blood pressure kept dropping and heart rate kept spiking. Had chills and aches off and on for 48 hours. orthostatic hypotension. It?s now been 5 days since being released and I?m still dizzy. Feels like I?m off balance/vertigo. Syncope has subsided but dizziness is still present.,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/23/2021,02/24/2021,1.0,OTH,Spirnolactone for acne,None,None,,None,"['Balance disorder', 'Blood pressure decreased', 'Blood test normal', 'Chills', 'Computerised tomogram normal', 'Dizziness', 'Heart rate increased', 'Orthostatic hypotension', 'Pain', 'Pregnancy test negative', 'SARS-CoV-2 test negative', 'Syncope', 'Vertigo']",2,MODERNA,SYR 1070913,AZ,82.0,F,"10:05 am Pt received vaccine and was seated in observation area. Pt alert, interacting with staff and other pts. 10:15am Pt appears asleep, rouses with touch and when spoken to. Observation area nurse notified, provided pt with bottle of water and helped her take a drink. Nurse then notified pharmacist who came to pt's side. Pt given 25 mg benadryl caplet. Able to swallow it, needed assistance for holding water bottle. Pt breathing regular, pulse regular and easily palpable. 10:25 Pt increasingly lethargic. Nurse and pharmacist with pt. Lips and tongue slowly swelling, responsiveness decreasing. Pharmacist called 911. 10:30am Pt's daughter administered epipen 30mg, L outer thigh. Swelling of lips and tongue quickly resolving. Pt lethargy increasing. Increasingly slow to open eyes and respond to questions. Pulse and breathing continue regular. EMS arrived on scene approx 10:35-10:40. BP 80/60, NSR, pulses palpable, pupils reactive, able to answer questions but slow to respond and weak voice. Pt transferred to Medical Center. In ER pt given IV solumedrol, IV fluids, CXR, EKG. Awake and oriented, arms shaking, weak, requires assistance to stand, intermittently drowsy. Admitted for observation. 3/3/21 pt preparing for discharge, BP extremely high. Pt given metoprolol, BP increased, tachycardia increased, pt very drowsy. Continued to monitor, given Lisinopril, bp decreasing. Pt feeling much stronger, alert, interacting with staff and daughter. Discharged home.",Not Reported,,Yes,Yes,1.0,Not Reported,Y,03/02/2021,03/02/2021,0.0,PHM,Lisinopril 10 mg daily,none,"hypertension, atrial fibrillation, vertigo",,"scallops, IV contrast (anaphylaxis), augmentin, levofloxacin","['Alanine aminotransferase normal', 'Anion gap increased', 'Aspartate aminotransferase normal', 'Asthenia', 'Basophil count decreased', 'Bilirubin urine', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bilirubin normal', 'Blood calcium decreased', 'Blood chloride normal', 'Blood creatinine normal', 'Blood lactic acid decreased', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea normal', 'Blood urine absent', 'Carbon dioxide decreased', 'Chest X-ray', 'Dysphonia', 'Dysstasia', 'Electrocardiogram', 'Eosinophil count decreased', 'Eosinophil percentage decreased', 'Full blood count', 'Globulin', 'Glomerular filtration rate normal', 'Glucose urine absent', 'Grip strength decreased', 'Haematocrit normal', 'Haemoglobin normal', 'Hypertension', 'Hyporesponsive to stimuli', 'Lethargy', 'Lip swelling', 'Lymphocyte count decreased', 'Lymphocyte percentage', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Monocyte count normal', 'Monocyte percentage', 'Neutrophil count', 'Neutrophil count increased', 'Nitrite urine absent', 'Platelet count normal', 'Protein total normal', 'Protein urine absent', 'Red blood cell count normal', 'Red cell distribution width normal', 'Slow response to stimuli', 'Slow speech', 'Somnolence', 'Swollen tongue', 'Tachycardia', 'Tremor', 'Troponin', 'Troponin I normal', 'Urine analysis', 'Urine ketone body absent', 'Urine leukocyte esterase', 'White blood cell count normal']",1,PFIZER\BIONTECH,IM 1070937,AL,81.0,M,Unwitnessed Cardiac arrest. ACLS protocols were performed. Cessation of resuscitation was called in the field by Dr.,Yes,03/03/2021,Not Reported,Not Reported,,Not Reported,,02/18/2021,03/03/2021,13.0,UNK,,,,,,"['Cardiac arrest', 'Resuscitation']",UNK,MODERNA, 1070965,CA,73.0,M,"right sided embolic stroke, right retinal artery occlusion occurred 8 hours after vaccination, requiring hospitalization for 2 days, he is now left with right eye visual loss as the only sequelae to the stroke",Not Reported,,Yes,Yes,2.0,Yes,N,02/24/2021,02/24/2021,0.0,PVT,"asa 81 mg daily, crestor 10 mg daily, uloric 40 mg daily, valsartan 80 mg daily","HTN, CHOL, Gout","HTN, CHOL, Gout",,none,"['Angiogram cerebral', 'Arteriogram carotid', 'Blindness unilateral', 'Computerised tomogram head', 'Echocardiogram', 'Embolic stroke', 'Magnetic resonance imaging head', 'Retinal artery occlusion', 'Ultrasound Doppler']",2,PFIZER\BIONTECH,IM 1070975,AZ,24.0,F,Patient was given the vaccination and then waited seated for 15 minutes. At 15 minutes patient started to stand and then fainted. Patient was breathing and had a pulse. Patient was placed on back and feet elevated and 991 was called. Patient was coming too as paramedics arrived. paramedics checked vitals. Eventually patient was able to walk out on her own and did not want to go to hospital.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/03/2021,03/03/2021,0.0,PHM,,,,,,['Syncope'],1,JANSSEN,IM 1070978,TX,63.0,M,report of patient being admitted for a stroke after about a week after first dose of moderna vaccine,Not Reported,,Not Reported,Yes,,Not Reported,U,02/24/2021,03/02/2021,6.0,PVT,unknown,unknown,unknown,,unknown,['Cerebrovascular accident'],1,MODERNA,IM 1070986,MA,70.0,F,"Patient developed the immediate onset within 1-2 hours of severe coughing, shortness of breath, wheezing, increased intestinal gas, sore joints, throat pain and low grade fever of 99.8. Coughing and shortness of breath continued to worsen over the day and evening and persisted for several days requiring treatment with prednisone. There were no other apparent causes for these symptoms except for the COVID-19 vaccination.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/26/2021,02/26/2021,0.0,PVT,Flovent inhaler Singulair,Chronic persistent asthma well controlled,Asthma GERD Osteoarthritis,prevnar 13 tetanus,"Apple, balsam of peru, black dye, canola oil, cinnamon, coconut, cottonseed, grape, honey, mango, menthol, methyl salicylate, mold, peach, peas, peppermint, pineapple, Prevnar 13, pseudoephedrine, ragweed, soy, strawberry, sulfonamides, tetanus vaccine, red dye and latex.","['Arthralgia', 'Cough', 'Dyspnoea', 'Flatulence', 'Oropharyngeal pain', 'Pyrexia', 'Wheezing']",UNK,MODERNA,IM 1071004,NY,57.0,M,Patient endorsed chest pain one hour following administration of the vaccine.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/25/2021,02/25/2021,0.0,PVT,,,Non-insulin dependent Diabetes Mellitus Coronary artery disease Obstructive sleep apnea Hyperlipidemia,,,"['Arteriogram coronary abnormal', 'Chest pain', 'Coronary artery stenosis', 'Troponin increased']",1,PFIZER\BIONTECH,IM 1071051,CO,84.0,F,"she had TIA (a mini stroke) on 2/15/2021 put in the hospital and got released the next day, doctor said is ok to get 2nd covid 19 shot.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/02/2021,02/15/2021,13.0,PHM,,,,,,['Transient ischaemic attack'],1,MODERNA,IM 1071195,,70.0,F,Mental state has changed since second dose. Alzheimer's symptoms have become very noticeably worse since second dose of Moderna Covid vaccine.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/01/2021,02/01/2021,0.0,PUB,rivastigmine and memematine,none,Alzheimer's,,penicillin,"['Condition aggravated', ""Dementia Alzheimer's type"", 'Mental status changes']",2,MODERNA,SYR 1071109,WA,44.0,F,"Cellulitis reaction at injection site; Hives all over body; Her arm was sore, warm and tender; Her arm was sore, warm and tender; A spontaneous report was received from a nurse concerning herself, a 44-year-old white female patient who developed a cellulitis reaction at injection site her arm was sore, warm and tender and hives all over body. The patient's medical history included rheumatoid arthritis and allergy to Demerol. Products known to be used by the patient within two weeks prior to the event included methotrexate, sertraline hydrochloride and multivitamin. On 08 Jan 2021, two days prior to the onset of event her arm was sore, warm and tender, the patient received the first of two planned doses of mRNA-1273 (Batch number 037K20A) intramuscularly into left arm for prophylaxis of Covid-19 infection. On 09 Jan 2021, the patient's reported that her arm was sore, warm, and tender. On 13 Jan 2021, the patient reported a cellulitis reaction at the injection site (medically significant) and hives all over her body (under both armpits, back of knees, ankles, wrists, and fingers). Treatment for the event included cefalexin and prednisone. On 20 Jan 2021, the cellulitis is improving and was not red anymore and the hives were starting to go away. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events a cellulitis reaction at injection site her arm was sore, warm and tender and hives all over body was recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,UNK,METHOTREXATE; ZOLOFT; MULTIVITAMINS [VITAMINS NOS],Drug allergy (allergic to Demerol),Medical History/Concurrent Conditions: Rheumatoid arthritis,,,"['Injection site pain', 'Injection site warmth', 'Urticaria', 'Vaccination site cellulitis']",1,MODERNA,OT 1071110,IL,,F,"Vaccine has made dementia worse; A spontaneous report was received from a consumer (patient's husband), concerning a 91-years-old, female patient who experienced vaccine has made dementia worse. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 28JAN2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 032L20A] intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 29JAN2021, the reporter claims after his wife was vaccinated her dementia has got worse and she is in fantasy world. Treatment information was not provided. The event worsening dementia due to vaccine was assessed as medically significant. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event worsening dementia due to vaccine was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/29/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Dementia'],1,MODERNA,OT 1071111,MT,66.0,F,"Chest pain; Joint aches; Body aches; Fever; Chills; Fatigue; Nausea; A spontaneous report was received from a 66 year old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced chest pain, body and joint aches, fever, chills, fatigue, and nausea. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 on 10-Jan-2021. On 11-Feb-2021, approximately 2 days prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly for the prophylaxis of COVID-19 infection. On 11-Feb-2021, the patient developed body and joint aches, chest pains, fever, chills, fatigue, nausea, and just hurt all over and felt terrible. On 12-Feb-2021, the patient's symptoms persisted, and she was in the emergency room (ER) to be treated. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable. The outcome of the events, chest pain, body and joint aches, fever, chills, fatigue, and nausea, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,02/11/2021,32.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Arthralgia', 'Chest pain', 'Chills', 'Fatigue', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,OT 1071112,CA,83.0,M,"Renal failure; Horrible Headaches; Body ache; A spontaneous report was received from a consumer concerning an 83-year-old male patient, who was administered Moderna's COVID-19 vaccine and one week later, he had horrible headaches, body ache and hospitalized for kidney problem (Renal failure). The patient's medical history included diabetes and high blood pressure. Products known to have been used by patient, with in two weeks prior to the event, included apixaban, sitagliptin, carvedilol, furosemide, glipizide. Patient became COVID positive on 14-DEC-2020 while in the hospital and survived. On 02-Feb-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 09-Feb-2021, approximately one week later, patient had horrible headache and body ache. Patient is better now but he is in the hospital because he has kidney problems (Renal failure) started on 14-Feb-2021. Patient's wife mentioned in call that this has never happened in past and she already asked MD not to give him the second dose. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was discontinued. The outcome of the events, he had horrible headaches, body ache, were considered resolved. The outcome of the event hospitalized for kidney problem (Renal failure) was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Patient's elderly age and medical history of diabetes and high blood pressure may have been contributory for the event of renal failure.",Not Reported,,Yes,Yes,,Not Reported,Y,02/02/2021,02/09/2021,7.0,UNK,GLIPIZIDE; ELIQUIS; JANUVIA [SITAGLIPTIN PHOSPHATE]; CARVEDILOL; FUROSEMIDE,Diabetes; Hypertension,Medical History/Concurrent Conditions: COVID-19 (Positive),,,"['Headache', 'Myalgia', 'Renal failure']",1,MODERNA,OT 1071113,,,F,"hallucinating; seeing spots; dreaming is unbelivable; pain; buzzing on her neck; body has no strength; could not stand straight; nausea; vomiting; A spontaneous report was received from a female consumer regarding herself who received first dose of Moderna Covid-19 vaccine (mRNA-1273)and have experienced hallucinations, excessive dreaming, loss of strength, inability to stand up, feeling abnormal, pain, nausea and vomiting. The patient's medical history was not provided. Her concomitant medications were not provided. No information on allergies. On 14-FEB-2021, prior to the onset of events, the patient received her first of two planned doses of Covid-19 vaccine (mRNA-1273) for the prophylaxis of Covid-19 infection at noon time. On 15-FEB-2021, she said, she still feeling it in her brain, her head and her body. She has no energy, could not even get up, she has buzzing on her neck and her body has no strength. She is hallucinating, seeing spots, seeing all kinds of things and her dreaming is unbelievable. She had so much pain, nausea and vomiting. She hung up the phone saying no time for this. It is not known whether the patient has any psychiatric history in the past. Treatment information was not provided. Action taken with the 2nd dose of mRNA-1273 in response to the events was not reported. The outcome of the events was unknown at the time of report. Follow up information is expected.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/14/2021,02/15/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Abnormal dreams', 'Asthenia', 'Dysstasia', 'Feeling abnormal', 'Hallucination', 'Hallucination, visual', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,OT 1071114,MO,,M,"AFIB reaction; diarrhea; A spontaneous report was received from a consumer concerning a 70-year-old male patient, who experienced AFib/ MedDRA PT: atrial fibrillation and diarrhea/ MedDRA PT: diarrhoea. The patient's medical history included atrial fibrillation (AFib). No relevant concomitant medications were reported. On 27 Jan 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of Covid-19 infection. The patient stated that about a day and a half later following vaccination, he started experiencing AFib and diarrhea. He also reported that on the day of his vaccine, he took an echocardiogram and his heart was doing well. Patient was originally diagnosed with AFib in 2011. The patient stated that he is doing better today. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the events was not reported. The events, atrial fibrillation and diarrhea, were considered recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event,s a causal relationship cannot be excluded. Patient's medical history of atrial fibrillation is considered a confounder for the event of atrial fibrillation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,,,UNK,,,Medical History/Concurrent Conditions: AFib (Patient was originally diagnosed with AFib in 2011.),,,"['Atrial fibrillation', 'Diarrhoea']",1,MODERNA,OT 1071115,TX,83.0,F,"Stage 4 kidney failure; A spontaneous report was received from a consumer concerning an 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stage four renal failure. The patient's medical history was not provided. No relevant concomitant medications were reported. On 18 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 011L20A) intramuscularly on her right arm for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient was diagnosed with Stage-4 Kidney Failure. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The relatedness of the event (Kidney Failure) to the suspect drug is unknown. At the time of this report, the outcome of the event reported (Stage-4 Kidney Failure) was not resolved.; Reporter's Comments: This case concerns a 83-year-old, female patient, who experienced stage four renal failure. Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,02/11/2021,24.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Renal failure'],1,MODERNA,OT 1071116,,,M,"Multiple falls; A spontaneous report was received from a healthcare facility staff memberconcerning a male patient of unknown age who received Moderna's COVID-19 vaccination (mRNA-1273) and experienced multiple falls. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 23 Jan 2021, approximately 18 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 10 Feb 2021, the patient was hospitalized for multiple falls. The patient's wife stated that while in the hospital he tested positive for COVID. Moreover, the patient's wife also tested positive for COVID-19 infection. The patient was still in the hospital as of 17 Feb 2021. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was unknown.; Reporter's Comments: This case concerns a male patient of unknown age, who was hospitalized for multiple falls, 18 days after the administration of first dose of mRNA-1273. The patient tested positive for COVID-19 while in the hospital. Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/23/2021,02/10/2021,18.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Fall', 'SARS-CoV-2 test positive']",1,MODERNA,OT 1071117,,,U,"Passed away; UTI; Abnormal bleeding; A spontaneous report was received from a healthcare professional concerning a patient who received the Moderna COVID-19 Vaccine (mRNA-1273) and experienced abnormal bleeding, UTI, and passed away. The patient's medical history included a long term history of anticoagulation therapy. Concomitant product use included anticoagulation therapy. On 31Jan2021 prior to the onset of the events the patient recieved their first dose of mRNA-1273 (Lot number:not reported) intramuscularly for prophylaxis of COVID-19 infection. On 07Feb2021, the patient complained of abnormal bleeding. Patient was seen at clinic on 10Feb2021 and was diagnosed with a UTI and given antibiotics. An INR was also completed that day due to patient having a long term history of anticoagulation therapy. Results of that showed the INR to be 12. Prior to vaccination, patient's INR was normal and no changes to medications and diet were made after vaccination and prior to complaint starting. On 12Feb2021 the patient passed away. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 12Feb2021. The cause of death was unknown. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns an 82 year old male patient, with history of long term anticoagulation therapy (unknown indication), who experienced a fatal event of death and abnormal hemorrhage, 13 days after receiving second dose of mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death",Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,01/31/2021,02/07/2021,7.0,UNK,ANTICOAGULATION,Anticoagulant therapy (Long term history of anticoagulation therapy.),,,,"['Death', 'Haemorrhage', 'International normalised ratio', 'Urinary tract infection', 'Urine analysis']",1,MODERNA,OT 1071118,NC,88.0,M,"Tested positive for COVID-19; A spontaneous report was received from a consumer regarding himself, an 88-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was diagnosed and hospitalized with COVID-19. The patient's medical history was not included. It was stated that the patient takes other medications, however they were not identified. On 21 January 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On an unspecified date, the patient reported that he went to the hospital and was admitted for COVID-19. Medications were given as treatment, but not identified. He states that he has no clue what it is, it was given to him at the hospital. Consent to contact was provided. Action taken with mRNA-1273 was not reported. The outcome of the event, diagnosed COVID-19 positive after receiving the vaccine was considered unknown.; Reporter's Comments: This case concerns an 88-year-old male who was hospitalized with a serious unexpected event of COVID-19. The event occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,01/21/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['COVID-19'],1,MODERNA,OT 1071119,NY,,M,"tested positive for COVID-19; he wasn't breathing right; loss of sense of taste; loss of sense of smell; A spontaneous report was received from a consumer concerning a 70-year-old male patient, tested positive for COVID-19, had loss of sense of smell and taste, and was hospitalized because he was not breathing right/COVID-19. The patient's medical history included blood pressure, cholesterol and unspecified prostate. Concomitant medications included unknown medication for his blood pressure, unknown cholesterol medication, and unknown prostate medication. On 30 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) for prophylaxis of COVID-19 infection. On 02 Feb 2021, the patient had loss of sense of smell and taste. On 05 Feb 2021, he tested positive for COVID-19 and was hospitalized because he wasn't breathing right. He returned home on 08 Feb 2021. Treatment for the event included vitamins, dexamethasone, pantoprazole, steroids, and remdesivir. Action taken with mRNA-1273 in response to the event was not provided. The outcome for the event wasn't breathing right was resolve don 08 Feb 2021. The outcome for the events tested positive for COVID-19, had loss of sense of smell and taste was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/30/2021,02/02/2021,3.0,UNK,,Cholesterol; Hypertension,,,,"['Ageusia', 'Anosmia', 'COVID-19', 'Dyspnoea', 'SARS-CoV-2 test']",1,MODERNA,OT 1071120,AZ,64.0,F,"Atrial fibrillation; Feeling fluttery; Heart rate was racing and was increasing, went up to 175 just sitting; A spontaneous report was received from a consumer concerning a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial fibrillation, feeling fluttery, and heart rate was racing and was increasing, went up to 175 just sitting. The patient's medical history was not provided. Concomitant medications included Travatan for glaucoma. On 12 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Feb 2021, five hours after vaccination, the patient experienced a fluttery feeling, heart rate was racing and was increasing, heart rate went up to 175 just sitting. She took an EKG on her watch and it was atrial fibrillation. When she was sleeping, her heart rate was at 102 or the 90s, normally it would be in the 60s. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events, atrial fibrillation, feeling fluttery, and heart rate was racing and was increasing, went up to 175 just sitting, was unknown.; Reporter's Comments: This case concerns a 64 year old female patient, who was on hospice care experienced a fatal event of death, 1 day after receiving second dose of mRNA- 1273 (Lot# 030M20A). Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/12/2021,0.0,UNK,TRAVATAN,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Atrial fibrillation', 'Atrial flutter', 'Heart rate increased']",1,MODERNA,OT 1071121,,,U,"patient who has atrial fibrillation who needed special care after getting the vaccine; A spontaneous report was received from a Consumer reporting a patient who received Moderna's COVID-19 Vaccine and who has atrial fibrillation who needed special care (supportive care). The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 17 Feb 2021, the reporter contacted the Safety Department and enquired regarding a patient who has atrial fibrillation on an unknown date and needed special care after getting the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. At the time of this report, the outcome of the event, patient who has atrial fibrillation who needed special care after getting the vaccine, was unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,Atrial fibrillation,,,,['Atrial fibrillation'],1,MODERNA,OT 1071122,SC,,F,"Mild bell's palsy; Sore arm; A spontaneous report( was received from a 72 years old, female patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced events of sore arm and mild bell's palsy(facial palsy). The patient's medical history was not provide .No relevant concomitant medications were reported. ON 02-Feb-2021, prior to the onset of the events, the patient received their first dose of mRNA-1273 (lot: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 02-Feb-2021, post vaccination, the patient reported that her right arm was sore for a few days. No treatment information was provided. On 09 Feb 2021, the patient has extensive dental work in one side as the dentist tried to put an implant in and was unable to. On an undisclosed date, days following dental work, her lips on the left and right of her face were not matching. She stated that the rest of her face was fine. On an undisclosed date, her dentist and primary care physician diagnosed her with an extremely mild case of Bell's Palsy caused by the extensive dental work. The treatment received for the event included steroid injection. The outcome of the events was unknown.; Reporter's Comments: Patient's dentist and primary care physician diagnosed her with an extremely mild case of Bell's Palsy caused by the extensive dental work. Based on reporter's causality provided, the event is assessed as unlikely related to mRNA-1273.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/02/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"[""Bell's palsy"", 'Injection site pain']",1,MODERNA,OT 1071123,NJ,75.0,F,"minor heart attack; stent put in; A spontaneous report was received from a consumer who was also a 75 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a minor heart attack / myocardial infarction and stent was put in / stent placement. The patient's medical history was not provided. No relevant concomitant medications were reported. On 25-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection. On 13-Feb-2021, the patient experienced a minor heart attack and had a stent placement. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events, minor heart attack and stent was put in, was not provided.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/25/2021,02/13/2021,19.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Myocardial infarction', 'Stent placement']",1,MODERNA,OT 1071124,CA,94.0,M,"Pneumonia; coughing with bubble spit; STOPPED EATING AND WOULD NOT SWALLOW PILLS; PAIN IN ARM; NOT FEELING WELL; A spontaneous report was received from a consumer concerning a male patient of 94 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced pain in arm,felt unwell, coughing with bubble spit,stopped eating, would not swallow pills and pneumonia. The patients medical history was not provided.No relevant Concomitant medications were reported. On 08 Feb 2021,prior to the onset of events, the Patient received their second of two planned dose of mRNA-1273(Lot number: 031L20A) vaccine for prophylaxis of COVID-19 infection. On 09 feb 2021,patient experienced pain in arm and felt unwell. On 13 Feb 2021,patient experienced coughing with bubble spit,stopped eating and would not swallow pills. On 15 feb 2021,patient went to the hospital and was diagnosed with pneumonia and patient was hospitalized and received a negative covid test in the hospital. Treatment information for the event included IV and oxygen. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the event pain in arm and felt unwell were considered resolved on 10 feb 2021. The outcome for the event coughing with bubble spit were considered resolved on 14 feb 2021. The outcome for the event stopped eating and would not swallow pills were considered resolved on 15 feb 2021.The outcome for the event pneumonia was not provided.; Reporter's Comments: This case concerns a 94-year-old male who was hospitalized with a serious unexpected event of pneumonia along with NS unexpected malaise, cough, aversion to food and NS expected vaccination site pain. COVID-19 test negative. Event onset 30 days after the first dose of mRNA-1273. Treated with O2 and IV. Pneumonia outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/11/2021,02/09/2021,29.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Cough', 'Food aversion', 'Malaise', 'Pneumonia', 'SARS-CoV-2 test negative', 'Vaccination site pain']",1,MODERNA,OT 1071125,IA,,M,"Complete hearing loss; A spontaneous report was received from a physician concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced complete hearing loss. The patient's medical history was not provided by reporter. Concomitant product use was not provided by the reporter. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced complete hearing loss after receiving COVID-19 vaccine. Laboratory details were not provided. Treatment information was not reported. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, complete hearing loss, was unknown.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of Deafness, after receiving 1st dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Deafness'],1,MODERNA,OT 1071126,NJ,,M,"Unspecified side effects; A spontaneous report was received from a consumer, concerning a male patient (age unspecified) who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced unspecified side effects ( Vaccination Complications) The patient's medical history was not provided. No relevant concomitant medications were reported. On unspecified day in JAN-2021 (two weeks ago from the reporting date), approximately 20 hours, prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 (batch number not provided) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection. On an unspecified day in JAN-2021, the patient had experienced unspecified side effects and was hospitalized. Treatment information was not provided. The outcome of the event unspecified side effects was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information has been provided at this time and further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Vaccination complication'],1,MODERNA, 1071127,KY,,U,"Stevens Johnson syndrome; 1 blister on lip looks like outbreak of herpes; horrible outbreak of psoriasis; A spontaneous report was received from a healthcare professional concerning a 73-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced steven-johnson syndrome, oral herpes(blister on the lip which looks like an outbreak of herpes), psoriasis (bolus lesion on right arm, two bolus lesions on back, and legs). The patient's medical history included bad psoriasis. Products known to have been used by the patient, within two weeks prior to the event, included secukinumab for psoriasis, which the patient took on 21 JAN 2021 as per the reporter. No other relevant concomitant medications was reported. On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 04-Feb-2021, it was reported that the patient had blister on the lip which looked like an outbreak of herpes. It was also reported that the patient had a bolus lesion on right arm, two bolus lesions on back, and legs, had a horrible outbreak of psoriasis. The physician mentioned that it appeared as Stevens Johnsons syndrome. Treatment included secukinumab for psoriasis. Action taken with mRNA-1273 was unknown. The outcome of the events, steven-johnson syndrome, oral herpes (blister on the lip which looks like an outbreak of herpes), psoriasis (bolus lesion on right arm, two bolus lesions on back, and legs), were unknown.; Reporter's Comments: This case concerns a 73-year-old patient, who experienced Stevens-Johnson syndrome, oral herpes outbreak and outbreak of psoriasis. The patient's medical history included bad psoriasis and patient is on cosentyx for psoriasis. Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,02/04/2021,7.0,UNK,COSENTYX,Psoriasis,,,,"['Oral herpes', 'Psoriasis', 'Stevens-Johnson syndrome']",1,MODERNA, 1071128,,,F,"Unresponsive; A spontaneous report was received from Pfizer concerning a 32-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 DEC 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 04 JAN 2021, at 7:20 am, the patient died. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 04 Jan 2021. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: This case concerns a 32-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death. The cause of death was unknown. Plans for an autopsy were not provided. Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death",Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,N,12/28/2020,01/04/2021,7.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Sudden death'],1,MODERNA,OT 1071129,,,M,"Unresponsive; A spontaneous report was received from Pfizer concerning a 43-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 08 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 09 JAN 2021, the patient died. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 08 Jan 2021. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death",Yes,01/09/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,['Death'],1,MODERNA,OT 1071130,,,M,"Unresponsive; A spontaneous report was received from Pfizer concerning a 45-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 Dec 2020, approximately 24 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 29 Dec 2020, the patient was found deceased at home. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 29 Dec 2020. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: unknown cause of death",Yes,12/29/2020,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/29/2020,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Sudden death'],1,MODERNA,OT 1071131,,,F,"Unresponsive; A spontaneous report was received from Pfizer concerning a 50-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscular for prophylaxis of COVID-19 infection. On 31 Dec 2020, the patient died. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 31 Dec 2020. The cause of death was unknown. Plans for an autopsy were unknown.; Reporter's Comments: This case concerns a 51 year old, female patient, who experienced an unexpected event of Death, after receiving 1st dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. There is no contact information and no further follow up information is expected.; Reported Cause(s) of Death: unknown cause of death",Yes,12/31/2020,Not Reported,Not Reported,,Not Reported,N,12/31/2020,12/31/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Sudden death'],1,MODERNA,OT 1071132,,,M,"chronic hypoxia respiratory failure; Unresponsive; A spontaneous report was received from Pfizer concerning a 51-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had developed hypoxia a sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 07 Jan 2021, around 6:00 pm, the patient became increasingly hypoxic. He was transported to the hospital for acute on chronic hypoxia respiratory failure. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 12 Jan 2021 at 11:25pm. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death",Yes,01/12/2021,Not Reported,Yes,,Not Reported,N,01/07/2021,01/07/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No Reported medical history),,,"['Acute respiratory failure', 'Death']",1,MODERNA,OT 1071133,,,F,"Unresponsive; A spontaneous report was received from Pfizer concerning a 52-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 08 Jan 2021, approximately 2 hours prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 08 Jan 2021, the patient was monitored for the appropriate amount of time by nursing staff, following vaccination. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 08 Jan 2021 at 2:15pm. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: This case concerns a 52-year old, female patient, who experienced a sudden death 1 day after administration of first dose of mRNA-1273. The cause of death was not provided. Plans for an autopsy were unknown. Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death",Yes,01/08/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/08/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,['Sudden death'],1,MODERNA,OT 1071134,,,F,"Death; A spontaneous report was received from a reporter concerning a 56-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and had experienced death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Dec 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 08 Jan 2021, the patient died. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 08 Jan 2021. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death",Yes,01/08/2021,Not Reported,Not Reported,,Not Reported,N,12/23/2020,01/08/2021,16.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,['Death'],1,MODERNA,OT 1071135,,,F,"Unresponsive; A spontaneous report was received from Pfizer concerning a 56-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 09 Jan 2021, the patient was found deceased in her home. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 09 Jan 2021. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death",Yes,01/09/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/09/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Sudden death'],1,MODERNA,OT 1071136,,,F,"sepsis; respiratory failure; Fever; Unresponsive; A spontaneous report was received from Pfizer concerning a 56-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced respiratory failure, sepsis, fever and sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient began to have a fever. She was sent to the emergency room for evaluation. That evening, she died. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 11 Jan 2021. The cause of death was reported as respiratory failure and sepsis. Plans for an autopsy were unknown/not provided.; Reporter's Comments: This is a case of 56-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sepsis, fever, respiratory failure and sudden death. Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Respirtory Failure; Sepsis",Yes,01/11/2021,Yes,Yes,,Not Reported,N,01/04/2021,01/11/2021,7.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Pyrexia', 'Respiratory failure', 'Sepsis', 'Sudden death']",1,MODERNA,OT 1071137,,,F,"Unresponsive; A spontaneous report was received from Pfizer concerning a 58-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 04 Jan 2021, the patient died. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 04 Jan 2021. The cause of death was unknown/not reported. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death",Yes,01/04/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/04/2021,5.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No Reported Medical History),,,['Death'],1,MODERNA,OT 1071138,,,M,"Sudden death; A spontaneous report was received from Pfizer concerning a 60-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 08 Jan 2021, the patient died. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 08 Jan 2021. The cause of death was unknown/not reported. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death",Yes,01/08/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/08/2021,3.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Sudden death'],1,MODERNA,OT 1071139,,,F,"Sudden death; A spontaneous report was received from Pfizer concerning a 60-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sudden death. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 13 Jan 2021, the patient was found to be deceased at 3:00 am. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 13 Jan 2021. The cause of death was unknown/not reported. Plans for an autopsy were unknown/not provided. .; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death",Yes,01/13/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/13/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,['Death'],1,MODERNA,OT 1071140,MN,,F,"lip swelling and itchy; lip swelling and itchy; Injection site hot to the touch; Injection site itchy; Injection site hard like a baseball; Cellulitis; A spontaneous report was received from a consumer who was also a 40-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced cellulitis, injection site hot to the touch, injection site itchy, and injection site hard like a baseball, lip swelling and lip itchy. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 28 Jan 2021, approximately 19 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 010M20A) in the left arm for prophylaxis of COVID-19 infection. On 09 Feb 2021, the patient's injection site was hot to the touch, itchy, and hard like a baseball. On the same day patient went to the doctor diagnosed the symptoms as cellulitis. On 15 Feb 2021, the patient had lip swelling which was itchy. The patient also stated that patient took almonds but does not think patient had nut allergy. Treatment for the event included antibiotics, Trimethoprim at eight hundred mg and Sulfamethoxazole for injection site hotness, itchiness, and hardness which was stopped on 13 Feb 2021 and had Zyrtec for itchy lip swelling. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events was unknown.; Reporter's Comments: This case concerns a 40 Y/O F female with a medically significant and serious unexpected event of Cellulitis and NS unexpected lip swelling and lip pruritus, with injection site warm, itchy, and hard. The events occurred 13 days after the first dose of mRNA-1273. Treated with antibiotics. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,02/09/2021,12.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Cellulitis', 'Injection site induration', 'Injection site pruritus', 'Injection site warmth', 'Lip pruritus', 'Lip swelling']",1,MODERNA,OT 1071141,PA,92.0,F,"she had not been eating properly; she was found lying on floor of her house - likely having been there for 3 hours. Next morning found lying on the floor of the bathroom; On helping up she was confused but otherwise ok; she was found lying on floor of her house - likely having been there for 3 hours. Next morning found lying on the floor of the bathroom; This is a spontaneous report from a contactable consumer. A 92-year-old female patient received first dose of bnt162b2 (Formulation: Solution for injection, Lot number: EK1768), via an unspecified route of administration, on 15Jan2021 at single dose for COVID-19 immunisation. Medical history included t2diabetes, hypertension, arthritis, previous episodes of falling. The patient's concomitant medications included rampril, glimepiride, gabapentin, sitagliptin, atorvastatin, tolterodine l-tartrate (PREBLACON) all at unspecified doses. It was reported that on 16Jan2021 at around 6pm she was found lying on floor of her house - likely having been there for 3 hours. On helping up she was confused but otherwise ok (as reported). She remained ok for several hours before going to bed. Next morning found lying on the floor of the bathroom. It was reported that ambulance was called but did not go to hospital due to COVID risk and overcrowding. It was reported that blood sample was taken on an unknown date in 2021 and analysed. The doctor called and reported no abnormal findings in blood sample. Suggested possibility that she had not been eating properly. The outcome of the event she had not been eating properly was unknown, while for other events was recovering. The events occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event Syncope cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/16/2021,1.0,UNK,RAMPRIL; GLIMEPIRIDE; GABAPENTIN; ATORVASTATIN; PREBLACON; SITAGLIPTIN,,Medical History/Concurrent Conditions: Arthritis; Diabetes; Fall; Hypertension,,,"['Blood test', 'Confusional state', 'Eating disorder', 'Fall', 'Syncope']",1,PFIZER\BIONTECH, 1071142,CA,73.0,M,"injection site soreness; if he squeezed something it would hurt in his wrist; This is a spontaneous report from a contactable pharmacist. A 73-years-old male patient started to receive bnt162b2 (Pfizer-BIONTECH Covid-19 Vaccine,), intramuscular on 23Jan2021 (at the age of 73) as a single dose for COVID-19 vaccination. Medical history was not reported. There were no concomitant medications. The patient previously took TYLENOL. On 26Jan2021, the patient reported that he experienced mild side effects included injection site soreness that lasted for one day and in one of his joints, it wasn't any soreness, but in his wrist, if he squeezed something it would hurt. Both of these symptoms lasted one day. The pain was mild.. He clarifies the soreness lasted for 2 days, Sunday and Monday, and was gone by yesterday. The clinical outcome of the events was recovered, the outcome of the event of took TYLENOL was unknown. Information about batch lot number has been requested Amendment: This follow-up is being submitted to amend previously reported information: event was deleted.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/26/2021,3.0,UNK,,,,,,"['Arthralgia', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 1071143,FL,,F,"I am feeling very ill; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect received from a contactable Consumer reporting for herself. A 77 year old female patient received the first dose of bnt162b2 (BNT162B2) , via an unspecified route of administration on 27Jan2021 at single dose for covid-19 immunisation . Medical history included ongoing osteoarthritis, and ongoing autoimmune disorder(have 3 autoimmune diseases and just went through chemotherapy). Concomitant medication included propranolol hydrochloride (INDERAL), gabapentin (NEURONTIN), aciclovir (CYCLOVIR), vitamin C (ASCORBIC ACID), vitamin D (VITAMIN D NOS) , danazol (DANAZOL), hydrocortisone (HYDROCORTISONE), ibuprofen (IBUPROFEN), levothyroxine sodium (SYNTHROID), prednisone (PREDNISONE) , vitamin A (VITAMIN A RETINOL). The patient was feeling very ill in Jan2021 with outcome of unknown. The patient is wondering if her regular medication will interfere with the effectiveness of vaccine and if the reported event is because of vaccine or her other conditions. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/01/2021,,UNK,INDERAL; NEURONTIN; CYCLOVIR; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; DANAZOL; HYDROCORTISONE; IBUPROFEN; SYNTHROID; PREDNISONE; VITAMIN A [RETINOL],Autoimmune disorder (I have 3 autoimmune diseases and just went through chemotherapy.); Osteoarthritis (I also have Osteoarthritis.),Medical History/Concurrent Conditions: Chemotherapy (I have 3 autoimmune diseases and just went through chemotherapy),,,['Illness'],1,PFIZER\BIONTECH, 1071144,,,F,"blurry vision; headache; This is a spontaneous report from a contactable consumer (patient) via a medical information team. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on 29Jan2021, at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 29Jan2021, patient had blurry vision and headache. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/29/2021,0.0,UNK,,,,,,"['Headache', 'Vision blurred']",1,PFIZER\BIONTECH, 1071145,AZ,22.0,F,"face/head was numb on and off for just over 2 hours; Severe arm soreness stiffness for 2 days; Severe arm soreness stiffness for 2 days; fatigue; nausea; This is a spontaneous report from a contactable consumer. A 22-years-old non-pregnant female patient received BNT162b2 (Pfizer-BIONTECH Covid-19 Vaccine) Lot number=EL9262, via an unspecified route of administration in left arm, on 25Jan2021 at 09:00 ( at the age of 22) as a single dose for covid-19 immunisation. There were no other vaccinations within 4 weeks. Medical history included Asthma, rheumatoid arthritis, and insomnia. Concomitant medication included ethinylestradiol, levonorgestrel (DAYSEE). On 25Jan2021, the patient experienced severe arm soreness stiffness for 2 days, fatigue for 2 days, nausea, and on day 4 (29Jan2021) face/head was numb on and off for just over 2 hours. No issues with speech or motor function, but the numbness came and went in various parts of her face, scalp, and outer ears for 2 hours. The outcome of the events was recovered. It was unknown if the patient tested for COVID-19 post-vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,PVT,DAYSEE,,Medical History/Concurrent Conditions: Asthma; Insomnia; Rheumatoid arthritis,,,"['Fatigue', 'Hypoaesthesia', 'Musculoskeletal stiffness', 'Nausea', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 1071146,MA,33.0,M,"right arm which the vaccine was injected into became extremely sore and was unable to move it without feeling pain.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247, expiry date not reported), via an unspecified route of administration on the right arm on 28Jan2021 13:00 at single dose for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient reported experiencing right arm which the vaccine was injected into became extremely sore and was unable to move it without feeling pain on 29Jan2021 05:00. No treatment was received for the event. The patient recovered from the event on an unspecified date. No follow up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/29/2021,1.0,OTH,,,Medical History/Concurrent Conditions: COVID-19,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1071147,FL,67.0,F,"Rash on neck and chest; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 67-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9262), via an unspecified route of administration in the left arm on 30Jan2021 at 08:00 at 67-years-old at a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 09Jan2021 at 67-years-old (lot number=EL1284; vaccine location=Left arm; first dose; administration time: 08:00). On 31Jan2021 at 21:00, the patient experienced rash on neck and chest (non-serious). The clinical outcome of the event, rash on neck and chest, was not recovered. Since the vaccination, the patient has not been tested for COVID-19. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/31/2021,1.0,UNK,,,,,,['Rash'],2,PFIZER\BIONTECH, 1071148,NY,72.0,F,"Chills; Stomach issues; Fever of 100.4; Sort of feeling achy; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported), intramuscularly on the left arm on 25Jan2021 (13:45) at a single dose for COVID-19 immunization at the university clinic (not a military facility). Medical history allergy to penicillin; allergy to bees; allergy to environmental grass and ragweed; and was in muscle relaxant therapy. Concomitant medications included cannabidiol (CBD OIL) as muscle relaxer; and estrogens conjugated, medroxyprogesterone acetate (PREMPRO). The patient previously took SHINGRIX on 18Oct2019 (when the patient was 71 years old) for shingles vaccine, and had subacute thyroiditis, enlarged thyroid and glands, rash from wrist to arm and shoulder, swollen and sore arm, and swollen neck glands and thyroid around left side. The patient previously took codeine, and had allergy. On 25Jan2021 (20:00), the patient had sore arm. The sore arm improved the next day. On 30Jan2021 (between 18:00 and 19:00), the patient was ""sort of"" feeling achy. On 30Jan2021 (23:00), the patient had fever of 100.4 (unit was not provided). The patient took paracetamol (TYLENOL) as treatment for the fever, and started getting better. The patient got tested as a precaution, and was negative for COVID-19 test on 31Jan2021. On 31Jan2021 (between 08:00 and 09:00), the patient had stomach issues. On 31Jan2021 (13:00), the patient had chills. The outcome of the events, 'sore arm', 'achy', 'fever', 'stomach issues' and 'chills', was recovering. The patient was due to the second dose of vaccination on 15Feb2021, and wanted to know if it would be okay for her to get it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,SCH,CBD OIL; PREMPRO,,Medical History/Concurrent Conditions: Allergic reaction to bee sting; Muscle relaxant therapy; Penicillin allergy; Seasonal allergy,,,"['Body temperature', 'Chills', 'Gastric disorder', 'Pain', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1071149,LA,83.0,M,"Nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). An 83 -year-old male patient receieved bnt162b2 (BNT162B2) , intramuscular on 2Jan2021 09:30 toat SINGLE DOSE for an COVID-19 immunizattion. Medical history included lung disorder from an unknown date and unknown if ongoing had some lung issues in the past. She said that he was hospitalized in Jan2020 for something really odd , cough, pulmonary oedema , atypical pneumonia, mycobacterial infection; Couple of years ago and had to take some IV medications through a PICC line and that was about 2 years ago and it has cleared up. There were no concomitant medications. The patient experienced nausea and dizziness on 13Jan2021 04:00 The outcome of events was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,01/13/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Atypical pneumonia; Coughing; Lung disorder (had some lung issues in the past. She said that he was hospitalized in Jan2020 for something really odd.); Lung edema; Mycobacterial infection (Couple of years ago and had to take some IV medications through a PICC line and that was about 2 years ago and it has cleared up.),,,"['Dizziness', 'Nausea']",1,PFIZER\BIONTECH,OT 1071150,OR,26.0,F,"High blood pressure of 150/100; Arm swelling; Arm swelling/The swelling has gone down, but it is still swollen. It is still hurting.; Tenderness; Feeling faint/Felt dizzy; Some trouble breathing; disoriented; Fatigue; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN5318), via an unspecified route of administration at left arm on 28Jan2021 at 16:55 (reported as 4:55 PM) at SINGLE DOSE for COVID-19 immunisation. It was given at a vaccination clinic. The patient had no prior vaccination within 4 weeks and had no adverse events following prior vaccinations and that was why she thought she would be fine. The patient had no additional vaccines administered on same date of bnt162b2. Medical history included anxiety, peanut allergy, tree nut allergy, and has had anaphylactic reaction in the past. Family history included her dad has heart disease and her half sister has heart disease. There were no concomitant medications. Historical vaccine included flu vaccine on an unspecified date for immunization. The patient stated, ""You kind of feel yucky after the flu vaccine, but she has never had this with a flu shot."" The patient stated that she hasn't had a flu shot in years. The patient asked if arm swelling was a normal occurrence after vaccination and if side effects can last for 4 days. The patient reported that she received the first dose of the COVID vaccine on 28Jan and afterwards experienced, arm swelling, and tenderness that has last for 4 days. She also reported experiencing feeling faint, high blood pressure of 150/100 and some trouble breathing on an unspecified date and nausea. The patient further reported that she was calling because she got her first dose of Pfizer's vaccine and she was curious if this was normal and if she needs to go see her doctor and she wants to report the symptoms. After she got the injection she felt super faint and got really high blood pressure on an unspecified date. She was not sure if it was because she had anxiety, but she had trouble breathing on an unspecified date. She got nauseated afterwards. Her arm swelled up really big and the swelling has stayed there for four days. Her arm was still swollen on an unspecified date. She has allergies and has had anaphylactic reaction in the past. She was still nauseated and feels super tired. The patient asked how long do the symptoms last. The patient's weight was reported between 122 to 123 pounds. The patient clarified that the nausea started 15 minutes after she got the shot on 28Jan2021. The nausea has lasted through this. She got chills the next day (29Jan2021) after the shot. She has felt super fatigue. The swelling has gone down, but it was still swollen. It was still hurting. She has no idea if that was normal. She also felt dizzy and disoriented after getting the shot. She was not sure if it was because her blood pressure was so high. It was high for her because her blood pressure was normally low. She thinks her blood pressure 150/100 after she got the vaccine. The outcome of all the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/28/2021,0.0,OTH,,,Medical History/Concurrent Conditions: Allergy to nuts; Anaphylactic reaction; Anxiety; Peanut allergy,,,"['Blood pressure measurement', 'Chills', 'Disorientation', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Hypertension', 'Nausea', 'Pain in extremity', 'Peripheral swelling', 'Tenderness', 'Weight']",1,PFIZER\BIONTECH, 1071151,NC,77.0,F,"they gave her some IV because she was dehydrated; high blood pressure; felt like she was getting a migraine; she started getting dizzy; she has never had a hangover but it felt like she had a hangover; she didn't feel good; she was sick on her stomach; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. Patient received the first dose of the COVID vaccine and was experiencing high blood pressure on an unspecified date in Jan2021. Patient went to the ER and they told her something in the vaccine made it go up. Patient would like to know what in the vaccine would cause her blood pressure to go up and if any has experienced high blood pressure as a side effect of the vaccine. Patient reported that she didn't feel good, felt like she was getting a migraine and after that she started getting dizzy and she thought she was going to help herself and lay down on the bed for about 45 minutes and then she got up after that and walked around on Jan2021. She felt like, she has never had a hangover but it felt like she had a hangover, that was what it felt like, and she thought she hopes that doesn't last and she got up Wednesday morning (Jan2021) and went to her podiatrist appointment. She didn't feel good but she was okay so she went to the podiatrist and then later she was fixing supper and she had some grease in a pan that she fried something in and she thought she wanted to get some water in it so she went to go with the pan and she got to the door and took 3 steps back and she thought good Lord, there is something is wrong here. She did empty the water and the grease and she thought well it is going to have to stay there, it was right at the back door so anyway. Her son came home from work and she got him get the blood pressure cuff and take her pressure and it was 158/98 and she thought, this was not good. She said she will just go lay down for a while and she went on to bed. The patient was taken into the hospital via an ambulance. She sat there until about 4-5 hours and later they got to take her blood pressure and result was 189/92 on Jan2021. They gave her some IV because she was dehydrated and she got home, she lives about 30 miles form the hospital so they got home about 3 o'clock and next day she didn't feel good but she felt better. She confirmed she was not admitted to the hospital it was an ER visit and they sent her home. She felt Thursday was not a good day she came down off of what had her up. She was going to say no to the second dose because she was sick on her stomach and drunk as a dog, she was really dizzy, very dizzy and she just had to sit down quiet her self. She was supposed to have surgery but because of COVID it has been cancelled 3 times. The outcome of the events were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Blood pressure measurement', 'Dehydration', 'Dizziness', 'Hangover', 'Hypertension', 'Malaise', 'Migraine', 'Nausea']",1,PFIZER\BIONTECH, 1071152,MI,,M,"""It wasn't that bad. Not joint, just muscles.""; ""I was stiff""; fell on ice; next day, lower back pain plus legs; I had lower back pain; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect received from a contactable consumer (patient). A male patient of an unspecified age (reported as 84, unit unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Lot number and expiry date not reported) via an unspecified route of administration on 27Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported I had lower back pain on 27Jan2021, next day, lower back pain plus legs on 28Jan2021 and ""It wasn't that bad. Not joint, just muscles"", ""I was stiff"" on unspecified date. It was reported that the patient received 1st dose on 27Jan2021. Reporter fell on ice and asking if he can take Tylenol between the vaccine doses. After information given to reporter about his initial inquiry, reporter states, ""I am surprised how least I had a reaction. 1st day of vaccine, that evening, I had lower back pain. The next day, lower back pain plus legs. On the 3rd day, pain receding. Right now everything is fine"". ""It wasn't that bad. Not joint, just muscles."" ""I was stiff"". The outcome of the events I had lower back pain and next day, lower back pain plus legs was recovered on 01Feb2021. Outcome of ""It wasn't that bad. Not joint, just muscles"", ""I was stiff"" and ""fell on ice"" was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,UNK,,,,,,"['Back pain', 'Fall', 'Muscle disorder', 'Musculoskeletal stiffness', 'Pain in extremity']",1,PFIZER\BIONTECH, 1071153,NJ,71.0,M,"bleeding at injection site; large bruise; sensation of chill/cold at vaccination site at time of injection; soreness; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3249), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:00 (at the age of 71-years-old) at a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within 2 weeks of vaccination, included tamsulosin (MANUFACTURER UNKNOWN), finasteride (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN). The patient experienced bleeding at injection site, large bruise, sensation of chill/cold at vaccination site at time of injection, and soreness on 15Jan2021 13:00. The events were reported as non-serious. The clinical course was reported as: The bleeding at injection site saturated the Band-Aid, but subsided quickly; the large bruise, which was now diminished, but still exists some 17 days later (as reported); sensation of chill/cold at vaccination site at time of injection; and soreness, although not significant, it still persists to this date of reporting. The patient underwent lab tests and procedures which included nasal swab: negative on 26Jan2021. The patient did not receive any treatment for the events. The clinical outcome of bleeding at injection site was recovered on an unspecified date, sensation of chill/cold at vaccination site at time of injection was recovered on 15Jan2021, and large bruise and soreness was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,SEN,TAMSULOSIN; FINASTERIDE; PRAVASTATIN,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['SARS-CoV-2 test', 'Vaccination site bruising', 'Vaccination site coldness', 'Vaccination site haemorrhage', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1071154,,,F,"had an ""autoimmune response"" and reported to have experienced hives (on left leg) and dots that go ""off and on"" in different parts of the body; had an ""autoimmune response"" and reported to have experienced hives (on left leg) and dots that go ""off and on"" in different parts of the body; had an ""autoimmune response"" and reported to have experienced hives (on left leg) and dots that go ""off and on"" in different parts of the body; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. Medical history included Graves' disease. The patient's concomitant medications were not reported. The patient experienced had an ""autoimmune response"" and reported to have experienced hives (on left leg) and dots that go ""off and on"" in different parts of the body on an unspecified date. The outcome of events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,,,UNK,,,Medical History/Concurrent Conditions: Graves' disease,,,"['Autoimmune disorder', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH, 1071155,AR,61.0,F,"numbness in her lips; swelling in her face; her tongue was feeling funny; her throat was feeling strange; she had itchiness to her right hand; started to develop hives; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 01Feb2021 at 09:00 (at the age of 61-years-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. The patient experienced numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, she had itchiness to her right hand, and started to develop hives on 01Feb2021. The clinical course was reported as follows: Approximately 3 hours after receiving the vaccine, the patient started to experience numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, and she had itchiness to her right hand and started to develop hives. The patient stated that she cannot take diphenhydramine hydrochloride (BENADRYL), but she did take cetirizine hydrochloride (ZYRTEC) to help with the symptoms. The patient was still having symptoms at the time of reporting. Therapeutic measures were taken as a result of all of the events as aforementioned. The clinical outcome of numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, she had itchiness to her right hand, and started to develop hives was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,UNK,,,,,,"['Hypoaesthesia oral', 'Oropharyngeal discomfort', 'Pruritus', 'Swelling face', 'Tongue discomfort', 'Urticaria']",2,PFIZER\BIONTECH, 1071156,AZ,63.0,F,"Fever; joint & muscle pain; joint & muscle pain; Injection site - large red spot (about 4 inches in diameter); swollen; hot to touch; other vaccine same date dose number 6; This is a spontaneous report from a contactable healthcare professional (patient). This 63-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; EL3247) via an unspecified route of administration in the left arm on 29Jan2021 at 14:15 (at the age of 63-years-old) as a single dose for COVID-19 immunization. Medical history included allergy to shellfish and allergy to eggs, both from unknown dates and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EL0142) in the left arm on 11Jan2021; codeine from an unknown date for an unknown indication and experienced allergy; celecoxib (CELEBREX) from an unknown date for an unknown indication and experienced allergy; and alendronate sodium (FOSAMAX) from an unknown date for an unknown indication and experienced allergy. The patient reported fever, joint and muscle pain 24 hours after the vaccine and stated it lasted about 18 hours. She also reported about the injection site that it was a large red spot (about 4 inches in diameter), it was swollen and hot to touch starting about 24 hours after vaccination. She reported 3 days later it was still red, swollen and hot to touch. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of fever, joint and muscle pain were recovered on 31Jan2021. The clinical outcomes of large red spot (about 4 inches in diameter), swollen, hot to touch were not recovered. The clinical outcome of other vaccine same date dose number 6 was unknown. It was also reported that since vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,UNK,,,"Medical History/Concurrent Conditions: Egg allergy (known_allergies:celebrex, codeine, fosamax, eggs, shellfish); Shellfish allergy (known_allergies:celebrex, codeine, fosamax, eggs, shellfish)",,,"['Arthralgia', 'Myalgia', 'Product use issue', 'Pyrexia', 'Vaccination site erythema', 'Vaccination site swelling', 'Vaccination site warmth']",2,PFIZER\BIONTECH, 1071157,MO,72.0,F,"stomach cramps; massive diarrhea; nausea; headache; This is a spontaneous report from a contactable consumer (patient). This 72-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot EK9231) via an unspecified route of administration in the left arm on 22Jan2021 at 17:15 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history included anal cancer from 2009 and unknown if ongoing; and cancer Non-Hodgkin's lymph from 1993 and unknown if ongoing. The patient had no allergies to medications, foods or other products. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included sertraline 100 mg from an unknown date for an unknown indication; rosuvastatin 5 mg from an unknown date for an unknown indication and cetirizine hydrochloride (ZYRTEK) from an unknown date for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported on the fifth day (27Jan2021) she had stomach cramps, massive diarrhea, nausea and headache and had to lay down; lasting from about 09:00 to 18:00. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of stomach cramps, massive diarrhea, nausea and headache were recovered on 27Jan2021 at 18:00. It was also reported the patient was not tested for COVID-19 since vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/27/2021,5.0,PVT,SERTRALINE; ROSUVASTATIN; ZYRTEK,,Medical History/Concurrent Conditions: Anal cancer; Non-Hodgkin's lymphoma (Cancer 1993 non Hodgkin lymph),,,"['Abdominal pain upper', 'Diarrhoea', 'Headache', 'Nausea']",UNK,PFIZER\BIONTECH, 1071158,FL,67.0,F,"Left Arm Red, Hot and raised; Left Arm Red, Hot and raised; Left Arm Red, Hot and raised; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) via an unspecified route of administration on 21Jan2021 (at the age of 67-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included ""thyroid,"" high blood pressure, depression, anxiety, and osteoporosis. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. It was unknown if the patient had any allergies to medications, food, or other products. The patient received unspecified concomitant medications. The patient did not receive any pother vaccines within 4 weeks prior to the vaccine. On 21Jan2021, the patient experienced left arm red, hot, and raised at first. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The outcome of left arm raised was recovered. The outcomes of left arm hot and red was not recovered; left arm was still red and hot and it was day 12. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Anxiety; Blood pressure high; Depression; Osteoporosis; Thyroid disorder,,,"['Erythema', 'Feeling hot', 'Peripheral swelling']",1,PFIZER\BIONTECH, 1071159,LA,70.0,F,flu symptoms; This is a spontaneous report from contactable consumer via Pfizer Sales Representative. A female patient of age 08 decades (reported as late 70s) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as single dose on an unknown date for COVID-19 immunization. Medical history included: thyroid condition. On an unknown date patient felt like she had flu symptoms. Outcome of event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Thyroid disorder,,,['Influenza'],UNK,PFIZER\BIONTECH, 1071160,,,F,"Blood pressure spiked to 159/98 and 169/92; tachycardia (pulse rate 152); irregular rhythm; This is a spontaneous report from a contactable consumer (patient). An adult female patient received (BNT162B2, Solution for injection, Lot: ENS318), via an unspecified route of administration on Jan2021 in left arm at single dose for covid-19 immunisation. Medical history included Allergies to medications, food, or other products: Yes, and had severe adverse reaction to an unrelated vaccine in 1988 that resulted in epi-pen administration. The patient previously took epi-pen. On Jan2021, the patient stated that roughly 7 minutes in, she began experiencing tachycardia (pulse rate 152). She requested help and doctors examined her, it was nothing. She also had an irregular rhythm. Blood pressure spiked to 159/98 and 169/92. Bp and pulse came down somewhat over the next 90 minutes, but remained significantly higher than normal for 11 hours (bp: 140s-150s/high 80s-low 90s compared to high-end norm of 110-120/65-70); pulse: 112-114 sitting compared to high-end norm of low 70s). More importantly, the irregular rhythm had continued for 10 days now and she was being followed by a cardiologist. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient was treated for the adverse event. But not so much treatment, as much as monitoring. The outcome of the event irregular rhythm was not recovered and rest of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,UNK,B-12,,"Medical History/Concurrent Conditions: Drug allergy (Allergies to medications, food, or other products: Yes); Food allergy",,,"['Blood pressure increased', 'Blood pressure measurement', 'Heart rate', 'Heart rate irregular', 'Tachycardia']",1,PFIZER\BIONTECH, 1071161,DE,69.0,F,"Rash that itches; Hives are still bright and red, they are not on my face anymore or my neck, just my chest; Scalp itches something awful/back of legs itch/ankles itch/fingers itch; Redness on my arms; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. Medical history included high blood pressure from an unknown date. Concomitant medication included losartan and atorvastatin for blood pressure high. The patient reported that they were having a mild, they believe reaction. They were not in anaphylactic shock, their face hasn't swollen 'up to size' (not clarified), nothing like that. They have a rash that itches, have hives on their chest, but their scalp itches something awful, the back of their legs itch, their ankles itch, and their fingers itch. They don't have any swelling, but they do have redness on their arms, well they did last night. The redness of their arms is gone, but the hives are still bright and red and they are not on their face anymore or neck, just the chest. The events occurred on 30Jan2021. The patient took antihistamine as treatment for the events. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/30/2021,1.0,UNK,LOSARTAN; ATORVASTATIN,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Erythema', 'Pruritus', 'Rash pruritic', 'Urticaria']",UNK,PFIZER\BIONTECH, 1071162,CA,92.0,F,"tongue feels a bit swollen; This is a spontaneous report from a contactable consumer (patient). A 92-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL3249 and expiration date unknown) via an unspecified route of administration on 27Jan2021 (at 92 years old) at a SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications were unspecified; patient is taking a lot of medications. The patient stated that she just had the vaccine on Wednesday, 27Jan2021 and her tongue feels a bit swollen on an unspecified date in Jan2021. But it was getting better now. Patient asked what she should take as it seems to lighten a little bit. Since then it was quite bad, it is still swollen but not as bad as it was. Outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/01/2021,,UNK,,,,,,['Swollen tongue'],UNK,PFIZER\BIONTECH, 1071163,MO,62.0,M,"fever at 100.4; Headache; Nausea; Sniffles; Chills; he was beated down with sweat; body aches; does not have an appetite; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EH9899, intramuscular in the left arm, on 08Jan2021 16:30 at 0.3 mL, single for COVID-19 immunization. Medical history included ongoing high blood pressure and spinal surgery in Jan2019. Patient's eyesight was not the greatest. Patient previously received flu vaccine on an unspecified date (the last couple of years). Concomitant medication included amlodipine besilate for blood pressure. He was scheduled to get second dose on 29Jan2021. The Saturday before he was scheduled to get the second dose (23Jan2021), he started feeling sniffles and stuff. He went to urgent care and he was tested for covid and the test came back negative. He then kept feeling bad. He clarified that on 24Jan2021, he had headache and nausea. He had chills and he was beated down with sweat; body aches which are constant and he would try to blame it on the position he was laying in while on the couch and it was not that; and does not have an appetite on an unspecified day in Jan2021. He has been in really bad shape for the last 9 or 10 days. When he went to go get his second shot, they would not give it to him due to his symptoms that he was experiencing since she had a fever at 100.4 the night before (28Jan2021). They scheduled him to get his second dose the following which was this Friday. He was asking if his side effects are totally normal. He cannot even sleep, reported that he will sleep an hour and then up for two or three hours. It really has him, and he feels miserable. The outcome of events Chills, nausea and fever at 100.4 was not recovered. Outcome of sniffles was recovered in Jan 2021 while the outcome of the remaining events was unknown. Therapeutic measures were taken as a result of sniffles; he went to urgent care and they gave him something like zyrtec, states it was an allergy medication and it wiped out the sniffles for fever, he will take Tylenol and it will break the fever for a few hours and then his fever comes right back. Follow-up attempts are completed. The information on the batch/lot number has been obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/01/2021,,PVT,AMLODIPINE BESYLATE,Blood pressure high,Medical History/Concurrent Conditions: Surgery; Vision abnormal,,,"['Chills', 'Decreased appetite', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pain', 'Pyrexia', 'Rhinorrhoea', 'SARS-CoV-2 antibody test']",UNK,PFIZER\BIONTECH,OT 1071164,NY,37.0,F,"Fullness/swollen sensation of throat with mild lymphadenopathy; Fullness/swollen sensation of throat with mild lymphadenopathy; This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3249), via an unspecified route of administration in Jan2021 as first single dose for COVID-19 immunization. Medical history included COVID prior to vaccination from an unknown date. No known allergies were noted. The patient's concomitant medications were not reported. The patient experienced fullness/swollen sensation of throat with mild lymphadenopathy in Jan2021 with outcome of recovered on an unspecified date in 2021. The patient underwent lab tests and procedures which included blood test/ antibody positive in May2020 and Nasal Swab/ PCR negative in Nov2020. There were no treatments given for the events. The clinical outcome of events was recovered on an unspecified date in 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,,,Medical History/Concurrent Conditions: COVID-19,,,"['Lymphadenopathy', 'Pharyngeal swelling', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1071165,CO,20.0,F,"headache; Dizziness; my blood pressure and it was spiking and dropping; I felt major pressure in my chest and under my left arm and down my left arm; I felt major pressure in my chest and under my left arm and down my left arm; my spine hurts in between my shoulder blades on and my left side of my neck hurts.; having episodes of racing heart; no energy; no appetite; left side of neck hurts; This is a spontaneous report from a contactable other hcp (patient). A 20-year-old female patient received their second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the right arm on 25Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included reflux and Known allergies: eggs, cashews, Kefex from an unknown date and unknown if ongoing. The patient previously took cefalexin (KEFEX) and experienced allergies. The patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) on 04Jan2021 10:00 on the left arm for COVID-19 immunisation. The patient reported that it started with headache about 8 hours after vaccination (not a small headache a pounding headache on the left side) on 25Jan2021. From that time on the headache was present, still is. Dizziness onset the next day and became worse while standing up and sitting down. So dizzy, they could not drive, their EMT company took their blood pressure and it was spiking and dropping - they felt major pressure in their chest and under their left arm and down their left arm, they took the patient to the hospital and was admitted, they did tons of tests that were all negative, but they were still dizzy and still had a terrible headache. These symptoms have not gone away, now their spine hurts in between their shoulder blades on and the left side of their neck hurts. They are still having episodes of racing heart while sitting (it will jump up to 135 for about 20 minutes and then drop back down). They have absolutely no energy and no appetite, they can't work and not getting any better. The patient underwent lab tests and procedures which included heart rate: 135 (it will jump up to 135 for about 20 minutes and then drop back down) on an unspecified date, laboratory test: negative on an unspecified date (they did tons of tests that were all negative), sars-cov-2 test: negative on 28Jan2021. Therapeutic measures were taken as a result of the events which included treatment with prednisone. The patient did not recover from the events. Information about the batch/lot number has been requested.; Sender's Comments: Based on a vaccine-event chronological association a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/25/2021,01/25/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Food allergy; Reflux gastritis,,,"['Asthenia', 'Blood pressure fluctuation', 'Chest discomfort', 'Decreased appetite', 'Dizziness', 'Headache', 'Heart rate', 'Laboratory test', 'Limb discomfort', 'Neck pain', 'Palpitations', 'SARS-CoV-2 test', 'Spinal pain']",2,PFIZER\BIONTECH, 1071166,,,U,"My eye, right eye, it started to blow up and a big black spot is coming in front of it, especially when I went to the bathroom and put on the light and that eye was totally blinded; It is happening every time I go to the bathroom or turn on the lights in the room or if I look up towards the ceiling, it starts showing me these two big black bubbles; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 08Feb2021 at a single dose for COVID-19 immunisation. Medical history included ongoing macular degeneration (the patient had in the past, actually quite a number of years, macular degeneration on that same eye). Concomitant medications were not reported. The patient had the vaccine and on the 8th of this month (not clarified), that was five or six days ago the patient really went well for both the days and both injections. But on Friday, two days ago, it began a little bit on Thursday evening but on Friday the patient noticed that the right eye started to blow up and a big black spot is coming in front of it, especially when the patient went to the bathroom and put on the light and that eye was totally blinded and then when the patient dabbed it with water and things and dried it up, it started to come back. It was happening every time, going to the bathroom or turning on the lights in the room or looking up towards the ceiling, it started showing these two big black bubbles. The outcome of the event was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/08/2021,,,UNK,,"Macular degeneration (I have had in the past, actually quite a number of years, macular degeneration on that same eye)",,,,"['Blindness', 'Eye disorder']",2,PFIZER\BIONTECH, 1071167,CA,27.0,M,"Occipital neuralgia; anaphylaxis; feeling like passing out on and off for the next 2-3 hours; he felt lightheaded; little short of breath; fatigue; he had a lot of posterior lymph pain in the back of his head, for 2 weeks on and off; heaviness at the back of his head left sid; chest tightness; he developed a sensation like he was going to lose control of his mind; This is a spontaneous report from a contactable Other Health Professional, the patient. A 27-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 08Jan2021 at 13:30 (at the age of 27-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included asthma exacerbation, GERD, childhood anemia, a retinal tear in the right eye all from unspecified dates and unknown if ongoing. The patient also reported medical history three episodes (June 2019, August 2019 and October2019) of anaphylaxis due to ""Exercise Induced Anaphylaxis."" Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899) on 21Dec2020 at 13:30 after which he experienced pain at the vaccination site which lasted twenty-four hours. The patient's past product use included adrenaline (EPIPEN), an unspecified corticosteroid and an unspecified antihistamine for past allergic reactions. The vaccine was administered in a hospital. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Concomitant medications included ciclosportin (RESTASIS), azelastine (AZELASTINE), mometasone furoate (FLONASE), cetirizine hydrochloride (ZYRTEC) and omeprazole (PROTONIX) all for unknown indications from unknown dates and unknown if ongoing. Within four weeks prior to the vaccination the patient had received unspecified ""allergy shots"" He received ""two shots"" (one in each deltoid) on 15Dec2021 and ""two shots"" (one in each deltoid) on 05Jan2021. The patient reported that fifteen to thirty seconds after the second dose of the COVID-19 vaccination he felt lightheaded and a little short of breath. This lasted about eight minutes and then subsided. Approximately thirty to forty minutes (about 30 minutes after he left the facility) later the symptoms returned. He felt short of breath and he thought he was going to pass out. The symptoms included fatigue, shortness of breath lightheaded and feeling like passing out on and off for the next two to three hours. He stated he has completely recovered. He continued to say that he was feeling fine for three days then he began having bilateral cervical lymph pain greater on the left than right, a lot of posterior lymph pain in the back of his head (for two weeks on and off). These symptoms also resolved on their own. He also experienced (""a couple of days later"") a sensation where he thought he was going to lose control of his muscles and lose consciousness. He also developed a sense that the was going to lose control of his mind with heaviness at the back of his head, left side. He went to the Emergency Room (date not provided) and they provided Valium. He also reports an Emergency Room visit on 13Jan2021 during which he underwent a CT scan of the head which was normal and a neuro consult suggesting occipital neuralgia and he was put on muscle relaxers. He also stated that experienced shortness of breath and chest tightness after his allergy shots on 26Jan2021 and he specified that he had never before had these reactions to his allergy shots. After that he had yet another possible allergic reaction after eating pizza on 30Jan which included throat swelling as well. He further stated that on 04Feb he had anaphylaxis vs asthma exacerbation. On the following day he developed a heaviness to his left occipital head with that same feeling of wanting to lose control of his muscles. He never had that before. He started Prilosec about one and one half weeks prior to the reporting date. In follow up the Other HCP reporter/patient answered ""Yes"" to the following questions (DCA) about symptoms experienced: Bilateral wheeze/bronchospasm, upper airway swelling, increased use of accessory respiratory muscles, dry cough, difficulty breathing (without wheeze or stridor, sensation of throat closure, tachycardia, nausea. These were reported without dates and without context with regard to the events reported initially. These were also reported as not requiring treatment and having recovered on unspecified dates. Lab data included three SARS COV 2 nasal swab tests (14Jan2021, 03Feb2021 and 11Feb2021) all of which were negative. Unspecified treatment was reported for the events anaphylactic reaction and mental impairment. The clinical outcomes of the events Anaphylaxis, loss of consciousness, dizziness, dyspnea, fatigue and lymph node pain were reported as recovered on an unspecified date in 2021. The clinical outcome of mental impairment, heaviness of head, chest tightness and occipital neuralgia were reported as unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/08/2021,0.0,PVT,RESTASIS; AZELASTINE; FLONASE; ZYRTEC; PROTONIX,,Medical History/Concurrent Conditions: Anaphylaxis; Anemia; Asthma exacerbation prophylaxis; GERD; Retinal tear,,,"['Anaphylactic reaction', 'Chest discomfort', 'Computerised tomogram', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Head discomfort', 'Loss of consciousness', 'Lymph node pain', 'Mental impairment', 'Occipital neuralgia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1071168,FL,66.0,F,"bled at the injection site; bruised; there are little fever blisters on the arm; her arm also felt hot; her arm was hurting; water bubble appear on my arm with fever; fever; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EN6200), via an unspecified route of administration on 16Feb2021 at 09:15 (at the age of 66-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines four weeks prior to the vaccination. The patient was not tested for COVID-19 post vaccination. On 16Feb2021 at 22:00 the patient experienced bled at the injection site; arm is bruised, states there are little fever blisters on the arm, the arm was hurting and the arm felt hot (clarified the whole arm) on 16Feb2021; and water bubble appeared on the arm with fever ""later on"" on an unknown date in Feb2021. The patient was treated for the bled at injection site, arm felt hot and pain in arm which included cold ice pack and ibuprofen. The events did not require a physician visit or hospitalization. The clinical outcome of the event bled at injection site was recovered on 16Feb2021, the bruising and fever blisters at injection site was recovering, feeling hot and pain in arm was not recovered, water bubble and fever was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/01/2021,,UNK,,,,,,"['Blister', 'Contusion', 'Feeling hot', 'Oral herpes', 'Pain in extremity', 'Pyrexia', 'Vaccination site haemorrhage']",1,PFIZER\BIONTECH, 1071169,MA,37.0,M,"Very mild headache; This is a spontaneous report from a contactable consumer (the patient). A 37-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3247), via an unspecified route of administration in the left arm on 16Feb2021 15:30 (at the age of 37-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3247), via an unspecified route of administration in the left arm on 27Jan2021 10:15 (at the age of 37-years-old) as a single dose for COVID-19 immunization. On 17Feb2021 13:00, the patient experienced a very mild headache. The patient was still able to focus at work. He had not needed to take any headache medicine yet. The clinical outcome of very mild headache was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Headache'],2,PFIZER\BIONTECH, 1071170,,,M,"dizziness; This is a spontaneous report from a non-contactable physician (patient's wife). This physician reported similar events for two patients. This is the first of two reports. A 64-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 01Feb2021, the patient experienced dizziness (non-serious) starting in the morning. The clinical outcome of the event, dizziness, was not recovered. No follow-up attempts are possible; information about batch/lot number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021173289 same drug/reporter/event and different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,02/01/2021,12.0,UNK,,,,,,['Dizziness'],1,PFIZER\BIONTECH, 1071171,AZ,45.0,F,"extreme muscle cramps in both legs; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at the left arm on 21Jan2021 15:00 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included magnesium, cannabidiol, and docusate sodium (COLACE). The patient experienced extreme muscle cramps in both legs on an unspecified date after the first shot. The patient underwent lab tests and procedures which included nasal swab: negative both on 15Feb2021 and 16Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,,,UNK,MAGNESIUM; CANNABIDIOL; COLACE,,,,,"['Muscle spasms', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1071172,MD,65.0,F,"2days after second dose I broke out into a extremely itchy rash over most of my body; This is a spontaneous report from a contactable Consumer. This consumer reported for self that the 65-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand Pfizer), via an unspecified route of administration from 16Feb2021 14:00 on left arm at single dose for covid-19 immunization. Medical history included Chemo for breast cancer 6 years ago. Concomitant medication included metoprolol (METOPROLOL) ER100mg, vitamin d3 (VITAMIN D3), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and multi vitamin. The patient previously took first dose of bnt162b2 (COVID 19, brand Pfizer) on 26Jan2021 03:00 PM, on Left arm for covid-19 immunization. No reaction with first dose. The patient experienced ""2days after second dose i broke out into a extremely itchy rash over most of my body"" (medically significant) on 18Feb2021 20:00 with outcome of not recovered. The patient underwent lab tests and procedures which included white blood cell count: remains low on unknown date. Therapeutic measures were taken as a result of 2days after second dose i broke out into a extremely itchy rash over most of my body (rash). She is not pregnant. No other vaccine in four weeks. Treatment received. ""Claritin helps a little but it is not subsiding. It's been four days since I had the shot"". No covid prior vaccination. No covid tested post vaccination. None known allergies.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/18/2021,2.0,WRK,METOPROLOL; VITAMIN D3; VITAMIN C [ASCORBIC ACID],,Medical History/Concurrent Conditions: Breast cancer female (Chemo for breast cancer 6 years ago.); Chemotherapy (Chemo for breast cancer 6 years ago.),,,"['Rash pruritic', 'White blood cell count']",2,PFIZER\BIONTECH, 1071173,,87.0,F,"Severe gas bloating; stomach cramps; Nausea; Feeling very weak; This is a spontaneous report from a non-contactable consumer reported for herself. An 87-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19), via an unspecified route of administration on 05Feb2021 10:30AM on right arm at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced severe gas bloating, stomach cramps, nausea, feeling very weak on 07Feb2021 with outcome of not recovered. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event was unknown. The case was assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/07/2021,2.0,UNK,,,,,,"['Abdominal distension', 'Abdominal pain upper', 'Asthenia', 'Nausea']",1,PFIZER\BIONTECH, 1071174,CA,74.0,F,"pain in chest through back; tongue swelled up; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number EL9764/EL9264), via an unspecified route of administration in the right arm on 01Feb2021 09:45 at a single dose for covid-19 immunization. Medical history included ongoing three stents in her artery, heart issue where they took test to see if she had a heart issue, and everything came back negative, high blood pressure, high cholesterol, overweight, penicillin allergy, IV iodine allergy, allergy to pollens, inhalants, dust and animals. There were no concomitant medications. The patient previously took phenytoin (DILANTIN), bacitracin;neomycin sulfate;polymyxin b sulfate (NEOSPORIN) and cefalexin (KEFLEX); all of which patient experienced allergies/ drug hypersensitivity. On 01Feb2021 09:45, immediately after receiving the vaccine, her tongue swelled up, she had difficulty swallowing, and she has a pain in her chest that went through to her back. The patient was sent and admitted to the ER and got an IV shot injection of diphenhydramine (BENADRYL) that got tongue back down. She didn't need an Epi pen, it wasn't that bad. They took the test to see if she had a heart issue, and everything came back negative. The patient was advised by the head of ER that she shouldn't get the second shot because of the reaction. It could be more severe with the second dose he said. The outcome of the events was recovered on 01Feb2021.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/01/2021,02/01/2021,0.0,PVT,,Stent placement,Medical History/Concurrent Conditions: Allergy to animals; Blood pressure high; Dust allergy; Fragrance sensitivity; Heart disorder; High cholesterol; Iodine allergy; Overweight; Penicillin allergy; Pollen allergy,,,"['Blood test', 'Chest pain', 'Dysphagia', 'Investigation', 'Swollen tongue']",1,PFIZER\BIONTECH, 1071175,HI,63.0,F,"My tongue felt like it was scolded and the back of it felt like it was swollen; This is a spontaneous report from a contactable consumer reported for herself. The 63-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19, Brand: Pfizer, Lot number: El9262) , via an unspecified route of administration on 30Jan2021 10:00AM on left arm at single dose for covid-19 immunisation. Medical history included asthma, gastrooesophageal reflux disease (Acid reflux (GERD)), dry eye syndrome, fibromyalgia, osteoarthritis, pre-diabetic, allergies to medications, food, or other products and all from an unknown date and unknown if ongoing. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]) supplements, melatonin and allergy medicine. The patient experienced ""my tongue felt like it was scolded and the back of it felt like it was swollen"" (medically significant) on 30Jan2021 10:30AM with outcome of recovered with sequelae (Recovered with lasting effects). Therapeutic measures were taken as a result of the event included ""IV Anti-histamine and prednisone I believe"". She is not pregnant or not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The consumer reported that ""Just after the shot I was fine while talking to my husband while waiting I had a fast onset strange feeling in my tongue and back of the throat. My tongue felt like it was scolded and the back of it felt like it was swollen."" Ae resulted in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,PVT,VITAMIN D [COLECALCIFEROL]; MELATONIN,,Medical History/Concurrent Conditions: Acid reflux (esophageal); Allergy; Asthma; Dry eye syndrome; Fibromyalgia; Osteoarthritis; Pre-diabetic,,,['Swollen tongue'],1,PFIZER\BIONTECH, 1071176,GA,72.0,F,"anaphylactic response; This is a spontaneous report from a contactable consumer (the patient). A 72-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) via an unspecified route of administration on 18Feb2021 08:45 a.m. at the age of 72 years old, at single dose in left arm for COVID-19 immunisation. No other vaccine was received in four weeks. No COVID prior vaccination, no COVID tested post vaccination. Medical history included Parkinson's. Concomitant medication included atorvastatin, carbidopa, flecainide, escitalopram oxalate (LEXAPRO), and metoprolol succinate (TOPROL), all taken for unspecified indication from an unspecified date. The patient previously took codeine and experienced ""allergies: Codeine"", dextropropoxyphene hydrochloride (DARVON) and experienced ""allergies: darvon"". The patient experienced anaphylactic response (onset date reported as ""13Feb2021"", pending clarification) which resulted in emergency room/department or urgent care. No treatment was received for the event. The outcome of the event was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,,,UNK,ATORVASTATIN; CARBIDOPA; FLECAINIDE; LEXAPRO; TOPROL,,Medical History/Concurrent Conditions: Parkinson's disease,,,['Anaphylactic reaction'],1,PFIZER\BIONTECH, 1071177,AZ,,M,"mildly pruritic erythematous macular morbilliform eruption on the lower back; mild subjective fevers; headache; injection site soreness in the deltoid region; This is a literature report. Herein, the authors report the development of a morbilliform rash on the trunk of a patient two days following vaccination, a hitherto unreported event. A 30-year-old male healthcare worker with no past medical history presented for vaccination with the SARS-CoV2, the Pfizer-BioNTech COVID-19 vaccine. The day after vaccination the patient experienced mild subjective fevers, headache, and injection site soreness in the deltoid region without overlying skin changes. Forty-eight hours after administration of the vaccine, the patient developed a mildly pruritic erythematous macular morbilliform eruption on the lower back (Figure 1). Over the course of the following 24 hours, the patient's rash resolved without intervention. Twenty-one days following the initial vaccine, the patient received the second dose of the PfizerBioNTech COVID-19 vaccine, after which he experienced chills, fatigue and myalgias. Forty-eight hours after administration of the second dose, the patient developed a recurrent morbilliform eruption most prominent on the bilateral flanks and flesh colored papules on the right flank with significantly increased pruritus and body surface area involvement. Notably, areas which were previously spared by the first rash including the flanks, proximal extremities and upper back were involved (Figure 2). Of note, regions affected in the first rash (lower back) were similarly affected in the recurrent rash. This rash similarly resolved over the following 24 hours without treatment. Herein, the authors report a case of morbilliform rash secondary to the Pfizer-BioNTech COVID-19 vaccine, like that seen in COVID-19 infection. Figure 1. A) Morbilliform, erythematous macular patches on the lower back of the patient. B) Closer view of morbilliform eruption, revealing erythematous macules with confluence and intervening areas of unaffected skin. Figure 2. Recurrent morbilliform eruption on the right flank with flesh-colored papules on the posterior right flank. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event rash morbilliform cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021226966 Same author, patient, drug/ different event.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Headache', 'Pyrexia', 'Rash morbilliform', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1071178,AZ,,M,"chills; fatigue; myalgias; recurrent morbilliform eruption most prominent on the bilateral flanks and fleshcolored papules on the right flank; recurrent morbilliform eruption most prominent on the bilateral flanks and fleshcolored papules on the right flank; This is a literature report from the Journal. A 30-year-old male healthcare worker with no past medical history presented for vaccination with the SARS-CoV2, the Pfizer-BioNTech COVID-19 vaccine. The day after vaccination the patient experienced mild subjective fevers, headache, and injection site soreness in the deltoid region without overlying skin changes. Forty-eight hours after administration of the vaccine, the patient developed a mildly pruritic erythematous macular morbilliform eruption on the lower back. Over the course of the following 24 hours, the patient's rash resolved without intervention. Twenty-one days following the initial vaccine, the patient received the second dose of the Pfizer/BioNTech COVID-19 vaccine, after which he experienced chills, fatigue and myalgias. Forty-eight hours after administration of the second dose, the patient developed a recurrent morbilliform eruption most prominent on the bilateral flanks and fleshcolored papules on the right flank with significantly increased pruritus and body surface area involvement. Notably, areas which were previously spared by the first rash including the flanks, proximal extremities and upper back were involved. Of note, regions affected in the first rash (lower back) were similarly affected in the recurrent rash. This rash similarly resolved over the following 24 hours without treatment. Accordingly, it is possible that the morbilliform rash observed in authors patient was similarly caused by immune activation, as the timing of rash onset closely coincided with vaccine administration. Herein, authors report a case of morbilliform rash secondary to the Pfizer-BioNTech COVID-19 vaccine, like that seen in COVID-19 infection. The presence of similar eruptions in SARS-CoV-2 positive patients and in this patient following vaccination with a mRNA vaccine suggests a similar underlying etiology of immune activation leading to the development of a morbilliform rash. An immune-mediated etiology is plausible in our patient's vaccine-related rash, as it was recurrent and notably more extensive following the second dose of the vaccine suggesting a more robust immune response. Thus far, rash has not been reported as an adverse effect in the Pfizer-BioNTech briefing document.; Sender's Comments: Based on the clinical information provided in this spontaneous publication, the company deems there is a reasonable possibility that all the reported events are related to the Pfizer-BioNTech COVID-19 mRNA vaccine. For all the reported events there is a plausible temporal association and, for the 'mildly pruritic erythematous macular morbilliform eruption' there is also a positive re-challenge, while chills, fatigue and myalgia, are known aspects of the product safety profile. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021213333 Same author, patient, drug; different event",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Chills', 'Disease recurrence', 'Fatigue', 'Myalgia', 'Rash morbilliform']",2,PFIZER\BIONTECH, 1071297,GA,72.0,M,"almost the full content of the vial was dropped down, Do not know how much was administered to the patient; needle was not properly attached; A spontaneous report was received from a pharmacist concerning a 72 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced needle was not properly attached and so almost the full content of the vial was dropped down, it sprayed out too fast and the amount of vaccine administered to the patient was unknown. The patient's medical history was not provided. Concomitant product use was unknown. On an unknown date, the patient received his first of two planned doses of mRNA-1273 (Batch number: unknown). On 18-FEB-2021, the patient received his second of two planned doses of mRNA-1273 (Batch number: 024M20A) intramuscularly in right arm for prophylaxis of COVID-19 infection. While administering the vaccine, the nurse noticed the needle was not properly attached and so almost the full content of the vial was dropped down. It sprayed out too fast and the nurse did not know how much was administered to the patient. Action taken with the drug in response to the events is not applicable. The outcomes of the events were considered resolved.; Reporter's Comments: This report refers to a case of 'needle was not properly attached' and �almost the full content of the vial was dropped down, Do not know how much was administered to the patient' for mRNA-1273 (lot# 024M20A) with no associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Device connection issue', 'Underdose']",2,MODERNA,OT 1071298,IA,,U,"One unpunctured vial was at room temperature for some time and was putted back in the refrigerator after that, the vial was administered; Expired vaccine used; A spontaneous report was received from a healthcare professional concerning multiple unknown patients who received Moderna's COVID-19 vaccine (mRNA-1273) from an unpunctured vial at room temperature for some time (unspecified how long) which was placed back in the refrigerator. After that storage error, the vial was administered to patients. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patients received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection. On an unknown date, one unpunctured vial was at room temperature for some time ( unspecified how long) and was placed back in the refrigerator. After that storage error, the vial was administered to unknown patients. No treatment information was provided. Action taken with mRNA-1273 in response to the event is not applicable. The outcome of the event storage error and expired product administered was considered resolved.; Reporter's Comments: This report refers to a case of product storage error and expired product administered for mRNA-1273, unknown lot, with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,02/18/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Expired product administered', 'Product storage error']",UNK,MODERNA,OT 1071299,NJ,85.0,F,"Pneumonia; health condition continued to deteriorate; chills; Body aches; She also fell; A spontaneous report was received from a consumer and physician concerning a 85 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pneumonia, fall, chils, myalgia and general health physical health deterioration. The patient's medical history included diabetes and blood pressure both since an unknown date. Relevant concomitant medications included diabetes medication and blood pressure medication. On Date 11-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On date 14-Feb-2021, the patient experienced chills and body aches. On an unknown date the patient fell and her health condition continued to deteriorate. On 18-Feb-2021 the patient was diagnosed with pneumonia due to which the patient was hospitalized on the same day. Laboratory details if provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event(s) chills, body aches, fell, health condition deterioration and pneumonia unknown.; Reporter's Comments: This case concerns an 85 year old, female patient, with medical history of HTN and DM, who experienced a serious unexpected event of pneumonia, among others, 8 days after receiving 2nd dose of mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/11/2021,02/14/2021,3.0,UNK,,Blood pressure; Diabetes,,,,"['Chills', 'Fall', 'General physical health deterioration', 'Pain', 'Pneumonia']",2,MODERNA,OT 1071300,OH,,F,"Died; A spontaneous report, was received from a consumer on a social media, concerning a 38-years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and died. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the event, the patient received dose of mRNA-1273 (Lot number: unknown), for the prophylaxis of COVID-19 infection. On 17-Feb-2021, social media interaction was posted concerning a death of a patient on an unknown date after receiving Moderna vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on an unknown date. The cause of death was not provided. Plans for autopsy were not provided.; Reporter's Comments: Very limited information regarding the event of death has been provided at this time. No further information will be available.; Sender's Comments: MODERNA, INC.-MOD-2021-018380:Same reporter; Reported Cause(s) of Death: Unknown cause of death",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Death'],UNK,MODERNA, 1071301,CO,,F,"Needle broke and disconnected from the syringe during administration; Needle broke and disconnected from the syringe during administration; A spontaneous report was received from a pharmacist, concerning a 39 year-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced needle broke and disconnected from the syringe during administration (device connection issue and underdose). The patient's medical history was not reported. No Relevant concomitant medications were reported. On 15 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 038K20A) intramuscularly for prophylaxis of COVID-19 infection. On 15 Feb 2021, the needle broke during the vaccine administration to the patient. Also, the needle disconnected from the syringe. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events was considered resolved on 15 Feb 2021.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273. There were no reported adverse events associated with this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Device connection issue', 'Incorrect dose administered']",1,MODERNA,OT 1071302,LA,,M,"Took vaccine directly out of fridge and vaccinated; A spontaneous report was received from a consumer concerning a 68 years-old male patient, who received Moderna (mRNA-1273) and experienced took vaccine directly out of fridge and vaccinated. The patient's medical history included obesity, diabetes, chronic obstructive pulmonary disorder (COPD) and dementia. Concomitant product use was not provided by the reporter. On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient's spouse reported upon administering vaccination, they took vaccine directly out of fridge and vaccinated patient. The patient's spouse read that it must be at room temperature before it is administered and inquired if it would be effective. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was unknown. The event took vaccine directly out of fridge and vaccinated was resolved on 26 Jan 2021.; Reporter's Comments: This report refers to a case of product preparation error for mRNA-1273, lot # 007M20A, with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,,COPD; Dementia; Diabetic; Obesity,,,,['Product preparation error'],1,MODERNA,OT 1071303,FL,,F,"arm was hot; Arm was red; Arm was swollen; it was not injected in the muscle; A spontaneous report was received from a reporter (consumer) concerning a 52 year old female patient, who received second dose of Moderna's COVID-19 vaccine(mRNA-1273) and experienced inappropriate route of vaccination and arm was red, swollen and hot. The patient's medical history was not provided. Relevant concomitant medications included Levothyroxine, weight loss medication, Paracetamol, and Ibuprofen. The patient received the first of two planned doses of mRNA-1273 on 15 Jan 2021. On 12 Feb 2021, patient received the second dose of mRNA-1273 (Lot number: 013L20A) intramuscularly for the prophylaxis of COVID-19 infection. The dose was given 5 inches below the injection site of the 1st dose and the patient's arm was swollen, red and hot. Treatment medications included Minocycline. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, inappropriate route of vaccination, was considered resolved on 12-FEB-2021. The outcome of the events arm was red, arm was swollen, arm was hot was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,02/12/2021,28.0,UNK,LEVOTHYROXINE; TYLENOL; ADVIL 12 HOUR,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Incorrect route of product administration', 'Vaccination site erythema', 'Vaccination site swelling', 'Vaccination site warmth']",2,MODERNA,OT 1071304,FL,,F,"Injection given through band aid; A spontaneous report was received from a consumer concerning a female patient of 90 years old, who received Moderna (mRNA-1273) vaccine and experienced injection given through band aid (wrong injection technique ) The patient medical history was not provided.Concomitant products were not provided. On 30 DEC 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273(batch number 029K20A) via intramuscular route for prophylaxis of COVID-19 infection. No adverse events reported after the first dose of COVID-19 vaccination. On 27 JAN 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273(batch number unknown) for prophylaxis of COVID-19 infection. Medication error occurred during second dose of vaccination as injection given through band aid wrong injection technique is followed). Laboratory details are not provided.Treatment detail were not given. Action taken with mRNA-1273 in response to the events was not applicable. The events outcome described above as a result of second dose of vaccination was resolved.; Reporter's Comments: This case concerns a 90-year-old female patient who was experienced injection given through band aid (wrong injection technique) (Batch #: unknown). There was no associated adverse event reported for the event of wrong injection technique.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/27/2021,28.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Wrong technique in product usage process'],2,MODERNA,OT 1071305,CA,,M,"Leaked on arm when received shot; Not receiving a full dose; A spontaneous report was received from a consumer concerning a 61-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced leaked on arm when received shot/ exposure via skin and did not receive full dose/ underdose. The patient's medical history included high anxiety (not specified). Products known to have been used by the patient, within two weeks prior to the event, included not specified medications for anxiety. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on an unspecified date. On 27 Jan 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27 Jan 2021, when the patient received Moderna vaccine some leaked onto patient's arm. Patient was told by hospital that administered the vaccine that he got a full dose. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The events, leaked on arm when received shot and did not receive full dose, were considered recovered/resolved on 27 Jan 2021.; Reporter's Comments: This report refers to a case of vaccine underdose and exposure via skin for mRNA-1273 (Batch number: Batch number not provided) with no associated AE's.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,UNK,,Anxiety (High),,,,"['Exposure via skin contact', 'Underdose']",2,MODERNA,OT 1071306,CA,,U,"Two doses of the Moderna vaccine within 3 days; A spontaneous report was received from a Healthcare professional (HCP) concerning one of her patients, of unspecified age and gender, who received Moderna (mRNA-1273) and who experienced two doses of the Moderna vaccine within 3 days. The patient's medical history was not provided. Concomitant product use was not provided. The patient received the first of two planned doses of mRNA-1273 (Batch number not provided) on an unknown date for prophylaxis of COVID-19 infection. HCP reported that one of her patient got two doses of the Moderna vaccine within 3 days (Inappropriate schedule of product administration), and would like to know how far they are supposed to be spaced out. When should the true second dose should be given. Treatment for the event was not provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event two doses of the Moderna vaccine within 3 days was resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, unknown lot number with no associated AEs. Causality for this medication error is not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Inappropriate schedule of product administration'],2,MODERNA,OT 1071307,NV,72.0,F,"Leaky needle, have patient remaining dose with what he thinks is the full dose; A spontaneous report was received from a pharmacist concerning a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported during vaccination, needle was not fully attached to barrel, competed the dose on the other arm with 0.2mL because pharmacist thought needle was leaked out. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 Jan 2021, the patient received their dose of mRNA-1273 (Batch Number: 038K20A), intramuscularly in the arm for prophylaxis of COVID-19 infection. On 28 Jan 2021, during vaccination of patient, needle was not fully attached to barrel. The Pharmacist completed the remining dose on the patient's other arm with 0.2mL because Pharmacist thought needle was leaked out. Laboratory details not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, during vaccination, needle was not fully attached to barrel, competed the dose on the other arm with 0.2mL because pharmacist thought needle was leaked out was considered resolved on 28 Jan 2021.; Reporter's Comments: This report refers to a case of device connection issue for mRNA-1273, Batch Number: 038K20A with no associated AEs. Causality for the device connection issue is not applicable",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Device connection issue'],UNK,MODERNA,OT 1071308,,,M,"One of the recipients was under 18; A spontaneous report was received from a nurse concerning a male patient who was less than 18 years old (Product administered to patient of inappropriate age) who received Moderna (mRNA-1273). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received his first of two planned doses of mRNA-1273 (Batch number:039K20A) on 09 Jan 2021, intramuscularly in the deltoid region for prophylaxis of COVID-19 infection. On 09Jan2021, one of the recipients was under 18 when he received the first dose of the vaccine on the hospital. He has had no known symptoms and has not taken any treatments since receiving the vaccine. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event one of the recipients was under 18 was recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273 (lot number 039K20A) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1071365,FL,78.0,M,"Experiencing hypoxemia; A spontaneous report was received from a consumer concerning a 78-year-old male patient who received Moderna's Covid-19 vaccine (mRNA1273) and experienced hypoxemia. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned dose of mRNA-1273 (Lot: 031L20A) intramuscularly on 02-FEB-2021 for prophylaxis of Covid-19 infection. On an unknown date, the patient experienced hypoxemia. The blood oxygen level of the patient went between 80-90% for a short time and then would recover. The patient reported ""it was getting a little tiring."" At the time of this report, the patient was still experiencing symptoms. The patient had not taken any treatment for the events. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, hypoxemia, was considered not resolved.; Reporter's Comments: This case concerns a 78 year old male patient, who was on hospice care experienced a fatal event of death, 4 to 5 days after receiving second dose of mRNA- 1273 (Lot# 031L20A). Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history is provided.),,,['Hypoxia'],1,MODERNA,OT 1071366,TX,,F,"Due for her 2nd dose last 13Feb2021 but due to inclement weather it was cancelled; Diarrhea; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inappropriate schedule of product administration and diarrhoea. The patient's medical history was not provided. No relevant concomitant medications were reported. On 16-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced Inappropriate schedule of product administration. On 19-Feb-2021, the patient had rescheduled their second planned dose of mRNA-1273 for prophylaxis of COVID-19 infection and the patient experienced diarrhoea. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events Inappropriate schedule of product administration and Diarrhoea was unknown.; Reporter's Comments: This case concerns a female patient of unknown age who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting inappropriate schedule of product administration and diarrhea. Considering the event of diarrhea occurred more than 1 month after receiving their first of two planned doses of mRNA-1273, the event is assessed as unlikely related to mRNA-1273.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,02/19/2021,34.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Diarrhoea', 'Inappropriate schedule of product administration']",UNK,MODERNA,OT 1071367,GA,81.0,M,"Blood pressure went down until he died; Couldn't hear his heartbeat; neck was sweating; He was cold; Couldn't get up; Death; Sick; immediately very tired; he was tired; Hands were shaking; Slept for too long; A spontaneous report was received on 18 Feb 2021 from a consumer concerning a 81-years-old, male patient who received Moderna's COVID-19 vaccine and developed immediately very tired, hands were shaking, neck was sweating, was cold, sick, couldn't get up, couldn't hear his heartbeat and blood pressure went down until he died. Patients' medical history, as provided by patient's spouse, was emergency room(ER) admission in November 2020 because he had a congested chest (he had fluid around his heart). At that time, they gave him pills for kidney function. Other concomitant medication reported was Coumadin, blood thinner. Two weeks before receiving the vaccine, patient's EKG was normal. On 11 Feb 2021, in the morning, patient received their first of two planned doses of mRNA-1273(BATCH/LOT # 007M20A) probably in the right arm for the prophylaxis of COVID-19 infection. On 11 Feb 2021, approximately after 15 minutes of receiving vaccine, they left and patient was immediately very tired, his hands were shaking. So, patient's spouse made them down sleep for too long. On Friday, 12 Feb 2021 she tried to pick him up, but he was tired, exhausted, and sick. On Saturday, 13 Feb 2021, she brought him a coffee and he couldn't hold it because his hands were shaking, so she gave him the coffee and then made him pee on the bed because he couldn't get up. At lunch time she made him eat something and he fell sleep again. His wife was hanging around him all day and around 7:30pm she realized that he was cold, and his neck was sweating, she couldn't hear his heartbeat. So, she called emergency services and when they arrived, her husband's blood pressure went down until he died. Treatment for the events were not provided. Action taken with mRNA-1273 was not applicable. Patient was pronounced dead on 13 Feb 2021 20:00. The cause of death was not provided. The plans for an autopsy were not provided. The events of blood pressure went down until he died and couldn't hear his heartbeat were fatal. The outcome for the remaining events were unknown.; Reporter's Comments: This case concerns an 81 year old, male patient, who experienced a serious event of death among others, 2 days after receiving mRNA- 1273 (Lot# 007M20A). Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death",Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,UNK,COUMADIN,,"Medical History/Concurrent Conditions: Heart failure, congestive",,,"['Blood pressure measurement', 'Cardiac failure', 'Death', 'Electrocardiogram', 'Fatigue', 'Feeling cold', 'Hyperhidrosis', 'Hypersomnia', 'Hypotension', 'Illness', 'Mobility decreased', 'Tremor']",1,MODERNA,OT 1071368,MA,76.0,M,"21 days between doses; A spontaneous report was received from a nurse concerning a 76-year-old male patient who received his second dose of mRNA-1273 21 days after his first dose. The patient's medical history was not provided. Concomitant product use was not provided. On 28 Jan 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 Batch number not provided) (site and route not provided) for prophylaxis of Covid 19 infection. On 18 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Batch number 010M20A) intramuscularly into his left arm for prophylaxis of Covid-19 infection. The patient was a resident at the reporter's facility (name not provided). The reporter, the patient's nurse, is concerned that the second dose was administered 21 days after the first dose. The nurse inquired whether there is information about delays longer than recommended between doses. The patient received both scheduled doses of mRNA-1273 therefore action taken with the drug in response to the event is not applicable. The event 21 days Between Doses outcome was considered resolved.; Reporter's Comments: This report refers to a case of Product administration error � Inappropriate schedule of product administration for mRNA-1273, lot # unknown/010M20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history provided),,,['Inappropriate schedule of product administration'],2,MODERNA,OT 1071369,CA,,F,"mistakenly given Pfizer vaccine for second dose (got first dose of Moderna); A spontaneous report was received from a healthcare professional concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) on first dose but accidently received Pfizer's COVID-19 vaccine on the second dose resulting in the event wrong product administered. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 29 Jan 2021, prior to the onset of event, the patient received her first of two planned doses of mRNA-1273 (lot number: 037K20A) for prophylaxis of COVID-19 infection. On 19 Feb 2021, for the second dose, the patient accidently received Pfizer's COVID-19 vaccine on the second dose. No adverse event was reported for the event. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event wrong vaccine administered was considered as recovered.; Reporter's Comments: This report refers to a case of wrong product administered with second dose with Pfizer vaccine and with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,02/19/2021,21.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Wrong product administered'],1,MODERNA, 1071370,VA,74.0,F,"woke up a little tired; Achy arm; Diarrhea; Inappropriate schedule of vaccine administered; A spontaneous report was received from a consumer who was also a 74-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced diarrhea, achy arm/vaccination site pain, tired/fatigue and inappropriate schedule of vaccine administered. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Lot: L0AM20A) on 28-Jan-2021. On 16-Feb-2021, approximately 6 hours prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Six hours, after receiving the second dose of the vaccine the patient reported that she had diarrhea, just once. She stated that went to sleep and woke up a little tired the next day and had some diarrhea. The patient reported that she was a little tired and slept for nine and a half hours. She also stated that she had an achy arm. On 17-Feb-2021, she stated that she was feeling fine at that time. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events, diarrhea, achy arm/vaccination site pain, tired/fatigue, was considered unknown . The outcome of the event, inappropriate schedule of vaccine administered, was considered recovered/resolved.; Reporter's Comments: This case concerns a 74 Y/O F with nonserious unexpected event of inappropriate schedule of product administration with mRNA-1273 (lot # unknown) and adverse events of NS unexpected diarrhea and NS expected vaccination site pain, fatigue. Adverse events occurred 6 hours after second dose mRNA-1273, and event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,BABY ASPIRIN; METFORMIN; PIOGLITAZONE; SIMVASTATIN,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Diarrhoea', 'Fatigue', 'Inappropriate schedule of product administration', 'Vaccination site pain']",1,MODERNA,OT 1071371,VA,,U,"Leaked to the patients shoulder and some squirted out the syringe; Leaked to the patients shoulder and some squirted out the syringe; Went down on shoulder; A spontaneous report was received from a pharmacist regarding an unidentified patient who received Moderna Covid-19 vaccine (mRNA-1273) and experienced leaked to the patients shoulder and some squirted out the syringe. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unspecified date, the patient received unknown numbered planned dose of mRNA-1273 (Lot# Unknown) intramuscularly in unspecified site for prophylaxis of COVID-19 infection. On unspecified date during vaccine administration by the nurse, some vaccine leaked over the patient's shoulder and some squirted out of syringe. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event leaked to the patients shoulder and some squirted out the syringe was considered resolved on unknown date.; Reporter's Comments: This report refers to a case of underdose, exposure via skin contact and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Device connection issue', 'Exposure via skin contact', 'Underdose']",1,MODERNA, 1071382,NJ,53.0,M,"On February 15, 2021, had fever and MASSIVE HEADACHE. Got worse each day. Went to ER on 2/19/21, was treated and release. Found unconscious in home on 2/20/21. Was hospitalized on 2/20/2021. Was diagnosed with varicella meningitis on 2/22/2021. Hosptalized till 2/25/2021. Still not well",Not Reported,,Yes,Yes,6.0,Not Reported,N,02/10/2021,02/15/2021,5.0,PVT,Losartan 50mg 1x a day,None,"Hypertension, Hemochromotosis",,None,"['Angiogram cerebral', 'Blood test', 'Chest X-ray', 'Computerised tomogram head', 'Computerised tomogram neck', 'Headache', 'Herpes zoster meningitis', 'Loss of consciousness', 'Lumbar puncture', 'Magnetic resonance imaging head', 'Malaise', 'Meningitis viral', 'Pyrexia', 'Urine analysis']",1,PFIZER\BIONTECH,SYR 1071385,GA,69.0,F,"chest pain, subjective fever 9 days after vaccine; 10 days after hospital admit Dx with pericarditis + 8mm pericardial effusion",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/10/2021,02/22/2021,12.0,UNK,"Advair HFA 230-21 MCG/ACT, Flonase , Losartan Potassium (25MG Tablet, 1 Oral daily) ,Bayer Low Dose (81MG Tablet Chewable, 1 Oral daily), ProAir HFA,, ZyrTEC (10MG Tablet, Oral qDay)",,"HTN, Asthma, hyperlipidemia, CAD, h/o breast cancer",,Sulfa,"['Angiogram', 'Chest pain', 'Pericardial effusion', 'Pericarditis', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1071387,MA,38.0,F,Acute appendicitis and inflamed gallbladder. Required appendectomy 2.5 weeks after 2nd dose of modern covid 19 vaccine,Not Reported,,Yes,Yes,8.0,Not Reported,N,01/27/2021,02/15/2021,19.0,WRK,,,,,,"['Appendicectomy', 'Appendicitis', 'Cholecystitis']",2,MODERNA, 1071389,MD,64.0,M,"Patient presented to the ED with severe lower abdominal pain. Patient reports pain as severe, 10/10, in the mid-lower abdomen, constant with radiation to the right LQ. He reports N/V as well. Of note, patient is on chemotherapy (currently FOLFIRI/cetuximab) and follows with an oncologist for his colon cancer. His oncologist believes that the cause of his presentation is due to him taking Imodium for his chemo-induced diarrhea. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,,02/11/2021,03/03/2021,20.0,PVT,,,"CAD, HTN, HLD, colon cancer with metastasis to right lung",,,"['Abdominal pain lower', 'Diarrhoea', 'Nausea', 'Pain', 'Vomiting']",1,PFIZER\BIONTECH,IM 1071396,SC,65.0,M,"ER admission on February 27th, discharged with a diagnosis of Bilateral Pulmonary Embolism and DVT of lower limb",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/19/2021,02/27/2021,8.0,PHM,"rosuvastatin 10 mg., olmesartan 20-12.5 mg., Vitamin C and D3, omega 3 supplement, CoQ10.",None known,Hypertension and hyperlipidemia,,None known,"['Angiogram', 'Deep vein thrombosis', 'Echocardiogram', 'Pulmonary embolism', 'Ultrasound Doppler']",1,MODERNA,IM 1071409,CA,16.0,M,"Since receiving his second dose of COVID-19 vaccine (Pfizer) on Sunday 2/21 he has had fever (tmax 103.0 F), headache, and stomach ache. His fever started on 2/21 and had persisted through 2/24. He woke up from a nap on 2/24 in the afternoon at 1600 had onset of severe chest pain. Then reoccurring multiple times throughout the evening. He was taken to a local hospital and the transferred to another hospital for higher level of care. Pediatric cardiology was consulted and treatment was started for suspected atypical pericarditis with colchicine 0.6mg BID and ibuprofen 600mg QID w/ famotidine 40mg QDay. His chest pain resolved the day of admission, even prior to starting treatment. Patient was discharged in clinically stable condition to follow up with pediatric cardiology in 2 weeks as outpatient.",Not Reported,,Yes,Yes,4.0,Yes,N,02/21/2021,02/24/2021,3.0,OTH,none,none,obesity,,none,"['Abdominal pain upper', 'Blood creatine phosphokinase MB increased', 'Chest pain', 'Echocardiogram normal', 'Electrocardiogram ST segment elevation', 'Headache', 'Pericarditis', 'Pyrexia', 'Troponin T increased', 'Troponin increased']",2,PFIZER\BIONTECH,IM 1071410,MD,66.0,F,"Pt presented to the ED with complaints of constipation and vomiting. Of note, patient has a hx of colon cancer with metastasis and is s/p right hemicolectomy. She is being treated with radiation and transitioning to a new chemotherapy regimen. Patient states that she has not been eating for several days and her oncologist referred her to the ED due to concerns of a bowel perforation. Patient has been evaluated by trauma and is currently being kept NPO with frequent abdominal exams. Patient remains in the hospital at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,,Not Reported,,02/04/2021,03/03/2021,27.0,PVT,,,"HTN, hypothyroidism, colon cancer with metastasis",,,"['Constipation', 'Hypophagia', 'Vomiting']",1,MODERNA,IM 1071438,MD,91.0,M,"Patient presented to ED for DVTs, currently being treated with warfarin and heparin bridge. Patient remains in the hospital at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,,Not Reported,,02/09/2021,03/03/2021,22.0,PVT,,,"CAD, HTN, HLD, CKD, recent fracture of right hip",,,['Deep vein thrombosis'],1,PFIZER\BIONTECH,IM 1071471,MD,89.0,F,"Patient presented to the ED with complaints of nausea and feeling unwell. She was found to be hypertensive with BP in the 220s/120s. Patient was started on a nicardipine drip and transferred to ICU for management. Patient remains in the hospital at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,,Not Reported,,02/11/2021,03/03/2021,20.0,PVT,,,"HTN, HLD",,,"['Hypertension', 'Intensive care', 'Malaise', 'Nausea']",1,PFIZER\BIONTECH,IM 1071497,MD,73.0,F,"Patient was admitted s/p right total hip arthroplasty with removal of hardware. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/02/2021,03/03/2021,29.0,PVT,,,"HTN, diabetes, kidney disease, hypothroidism",,,['Medical device removal'],1,MODERNA,IM 1071498,WI,82.0,M,"patient became progressively weak after vaccination, fell at home and was unable to get up",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/02/2021,03/03/2021,1.0,PVT,Current Outpatient Medications on File Prior to Encounter Medication Sig Dispense Refill ? acetaminophen (TYLENOL) 325 MG tablet Take 325-650 mg by mouth every 4 (four) hours as needed for Pain. � � ? albuterol 108 (90 Base) MCG/ACT inhaler,"COVID-19 diagnosed 11/13/2020, resulting in hospitalization from 11/17 to 11/25/2020 at MC, then transferred to another facility and hospitalized there from 11/25 to 12/15/2020. He was treated at Hospital with BiPAP, HFNC oxygen, duo nebs, dexamethasone. He reports that since being discharged from hospital on 12/15/2020 he has continued to have some lingering respiratory difficulties",COPD DM Type 2,,No known allergies,"['Asthenia', 'Chest X-ray abnormal', 'Dysstasia', 'Fall', 'Pneumonia']",2,MODERNA,IM 1071515,GA,72.0,M,"I called to speak with patient's wife about getting her scheduled for the first injection. She reported that patient, was hospitalized a week after getting his first injection and stayed in the hospital for 3 days. She states he presented with confusion, weakness, shakiness and was thought to originally have had a TIA and then was diagnosed with metabolic encephalopathy. She states he is completely different and now has to walk with a walker and confusion persists.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/18/2021,02/25/2021,7.0,PVT,,,,,,"['Asthenia', 'Confusional state', 'Metabolic encephalopathy', 'Tremor', 'Walking aid user']",1,MODERNA,IM 1071519,MD,67.0,M,"Patient was admitted to undergo a laparoscopic partial transverse colectomy. Patient remains hospitalized. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,,Not Reported,,02/17/2021,03/02/2021,13.0,PVT,,,"HTN, CAD, PVD, diabetes, HLD",,,['Colectomy'],2,MODERNA,IM 1071521,,87.0,M,Patient deceased one week post-vaccine,Not Reported,,Yes,Not Reported,,Not Reported,,01/20/2021,01/27/2021,7.0,UNK,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1071566,FL,,M,"intracranial hypertension; elevated blood pressure; Headache; A Spontaneous report received from a consumer concerning a male patient (demographics not provided) who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced intracranial hypertension, Headache, and elevated blood pressure. The medical history of patient was not reported. Concomitant medications included unspecified blood pressure medications. On 11 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (lot # not provided) intramuscularly (site of administration not provided) for prophylaxis of COVID-19 infection. On an unknown date in Feb 2021, post vaccination, the patient developed a headache and elevated blood pressure which was relieved by blood pressure medicine. The patient reported that the headache was caused by intracranial hypertension and would like the manufacturers to study the correlation between Covid vaccines and intracranial hypertension. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was not reported.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of Intracranial pressure increased among others, after receiving first dose mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Headache', 'Hypertension', 'Intracranial pressure increased']",1,MODERNA,OT 1071567,NJ,,F,"Polymyalgia rheumatica; A spontaneous report was received from a consumer concerning a 76-year-old, female patient who received Moderna's COVID-19 Vaccine and developed polymyalgia rheumatica. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 04FEB2021, approximately 15days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient received the 1st dose of the vaccine in her left/non-dominant arm on 04Feb2021. Patient was later diagnosed with polymyalgia rheumatica and treatment for the event included prednisone 10 mg. Patient wanted to know if prednisone would interfere with the Moderna covid vaccine she received. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The outcome of the event was unknown.; Reporter's Comments: This case concerns a 76 year old female patient, who experienced a serious unexpected event of polymyalgia rheumatica, after receiving first dose mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/18/2021,14.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Polymyalgia rheumatica'],1,MODERNA,OT 1071568,GA,84.0,M,"loss of hearing/hearing completely gone in right ear; Ringing in left ear; probably vertigo; Extreme dizziness; blood pressure was 214/113; vomitng; Weakness; nasal drip; dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee; diminished hearing in left ear/sounds like listening through a drum; pressure in temples like a hammer on each side of head; headache in back of head; A spontaneous report was received from a consumer who was also an 84-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme dizziness, nausea ,vomiting, nasal drip, weakness, loss of hearing/hearing completely gone in right ear (deafness unilateral), diminished hearing in left ear/sounds like listening through a drum (hypoacusis), blood pressure was 214/113 (blood pressure increased), pressure in temples like a hammer on each side of head (head pressure), headache in back of head, and dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee. The patient's medical history was not provided. Concomitant product use was not provided. On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 020L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. The patient reported he felt fine for about one week after the vaccination. Then, in the early morning of 05 Feb 2021, right after midnight, he experienced extreme dizziness, vomiting, weakness, nasal drip, and loss of hearing including ringing in his left ear and no sound in his right ear. He also started to notice a dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee. The patient was taken by ambulance to the hospital. In the ambulance, he vomited and his blood pressure was 214/113. He was placed the COVID-19 wing of the emergency room (ER) and given tests including a COVID-19 test, sonogram, ""echogram"", MRI, and EKG (results not provided). The patient reported he was admitted to the hospital. He was told he probably had vertigo. After his ER visit, the patient had appointments with his general practitioner, an ear nose and throat specialist, and a hearing specialist. He was told his hearing was completely gone in his right ear and diminished in his left ear. The patient could still somewhat hear out of his left ear but it sounds like listening through a drum. He states he has to have his television up very loud to be able to hear it. At the time of this report, the patient continued to feel extremely weak, dizzy, and he had pressure in temples like a hammer on each side of his head, a headache in back of his head, and the hearing changes. Treatment for the events included unspecified medications in the ER. Action taken with mRNA-1273 in response to the events was not reported. The events of dizziness, weakness, loss of hearing/hearing completely gone in right ear, vertigo, weakness, diminished hearing in left ear/sounds like listening through a drum, pressure in temples like a hammer on each side of head, and headache in back of head were not resolved at the time of this report. The outcome of the events of blood pressure was 214/113, nausea, nasal drip, vomiting, and dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee was unknown.; Reporter's Comments: This case concerns an 84 year old, male patient, who experienced a serious unexpected event of Deafness (unilateral) among others, 9 days after receiving 1st dose of mRNA- 1273 (Lot# 020L20A). Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/28/2021,02/01/2021,4.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Asthenia', 'Blood pressure increased', 'Blood pressure measurement', 'Deafness unilateral', 'Dizziness', 'Head discomfort', 'Headache', 'Hypoacusis', 'Rash', 'Rhinorrhoea', 'Tinnitus', 'Vertigo', 'Vomiting']",1,MODERNA,OT 1071569,CA,,F,"High blood pressure (200 systolic); Cold palms; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cold palms and high blood pressure (200) systolic. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced cold palms and high blood pressure (200 systolic) for which she was taken to the emergency room (ER). No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, cold palms and high blood pressure (200) systolic was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Hypertension', 'Peripheral coldness']",1,MODERNA,OT 1071570,IL,,F,"Tingling on left side of the body; Elevated blood pressure; Tongue began to swell; Facial tingling; Facial numbness; A spontaneous report was received from a physician concerning a 54-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling and numbness on the left side of the body, elevated blood pressure, swelling of tongue, facial tingling, and facial numbness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03 Feb 2021, immediately prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (batch# unknown) for prophylaxis of COVID-19 infection. The patient had an immediate reaction that resulted in tingling/numbness on the left side of her body as well as an elevated blood pressure. The numbness continued to her face/mouth and her tongue began to swell. After a short period of time, the tingling in the body subsided, but the numbness/tingling in the face persists. The health department where the patient received the vaccine attempted to call an ambulance, but the patient refused medical treatment. Action taken with mRNA-1273 in response to the events was not reported. The outcome of tingling on the left side of the body was recovered. The outcome of the events, elevated blood pressure, and swelling of the tongue were unknown. The events, facial tingling, and facial numbness were not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No adverse event reported),,,"['Blood pressure increased', 'Hemiparaesthesia', 'Hypoaesthesia', 'Paraesthesia', 'Swollen tongue']",1,MODERNA,OT 1071587,MD,86.0,F,"Patient presented to the ED after a mechanical fall resulting in left hip pain. She was found to have a fracture and underwent a left hip hemiarthroplasty. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,,Not Reported,,02/26/2021,03/02/2021,4.0,PVT,,,"HLD, osteoarthritis, depression, ovarian cancer",,,"['Arthralgia', 'Fall', 'Hip arthroplasty', 'Hip fracture']",1,PFIZER\BIONTECH,IM 1071592,GA,52.0,F,"Pt after discussion with treating allergist elected to complete dose 1 of Pfizer COVID-19 vaccination. Per pt report she had premedicated with Benadryl 100mg po prior to immunization and brought along her prescribed epi-pen. After reciept of vaccination, she proceed to recovery area where she was dictated to 30 minutes of observation, approximately 7 minutes after inoculation began having symptoms consistent with upper airway swelling and self-administered epi-pen and called for medical assistance. EMS was then called and upon arrival found her in stable condition and transported the patient to emergency room at Hospital.",Not Reported,,Yes,Not Reported,,Not Reported,Y,03/03/2021,03/03/2021,0.0,MIL,Tagamet 400mg one tab by mouth twice daily for angioedema Diphenhydramine 50mg one capsule by mouth every four hours for angioedema Zyrtec 10mg one tablet by mouth daily for angioedema Singulair 10mg one tablet by mouth daily for angioede,Vulvovaginal candidiasis diagnosed w/ Rx for Fluconazole Dx 6 days prior to immunization. Infusion of IV Immunoglobulin 19Feb2021 as part of treatment for severe idiopathic angioedema,allergic reaction to environmental items toxoplasmosis raynauds mast cell disease sjogrens syndrome osteonecrosis angioedema Rheumatoid Arthritis Sicca syndrome w/ keratoconjuncitivits occipital neuralgia gastroparesis,,Latex (Urticaria is the reaction) Levofloxacin (Facial swelling is the reaction) NSAIDS (Anaphylaxis is the reaction) Xolair (Angioedema and throat tightness is the reaction),"['Immediate post-injection reaction', 'Swelling', 'Upper airway obstruction']",1,PFIZER\BIONTECH,IM 1071608,MD,76.0,F,"Patient presented to ED with SOB and hypoxia. She stated that this is a chronic problem for her. She had a video conference with her physician who told her to go to the ER. Her O2 saturation was noted to be 87%. She was found to have pulmonary edema and received Lasix. She is also scheduled to have a cardiac cath to evaluate ventricular tachycardia. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,,Not Reported,,02/25/2021,03/02/2021,5.0,PVT,,,"Type 2 DM, COPD, heart failure, HTN, HLD, hypothyroidism",,,"['Condition aggravated', 'Dyspnoea', 'Hypothyroidism', 'Hypoxia', 'Pulmonary oedema', 'Ventricular tachycardia']",1,MODERNA,IM 1071612,MN,51.0,F,"Ringing in the ear. Hearing loss. Prescribed prednisone Take 40 mg day 1-2, 30 mg on day 3-4, 20 mg on day 5-6, 10 mg on day 7-8, 5 mg on day 9-10. Prescribed on 1/20/2021. Then on 3/3/2021 prescribed prednisone 20 mg tablets TAKE 1 TABLET 3 TIMES A DAY FOR 7 DAYS, THEN 1 TABLET 2 TIMES A DAY FOR 4 DAYS, THEN 1 TABLET D FOR 4 DAYS, THEN 1/2 TABLET D FOR 4 DAYS. Currently still has hearing loss and ringing in the ear.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/23/2020,12/28/2020,5.0,PVT,Bupropion XL 300 mg once daily. Escitalopram 20 mg once daily. Losartan 50 mg once daily. Nitrofuantoin 50 mg once daily. Acetaminophen 500 mg as needed. Ibuprofen 600 mg as needed.,"October 26th, 2020 diagnosed with Covid-19",High blood pressure. Chronic UTI's. Depression. Anxiety.,,NKA,"['Acoustic stimulation tests', 'Audiogram', 'Deafness', 'Otoscopy', 'Tinnitus', 'Tympanometry']",1,PFIZER\BIONTECH,IM 1071618,NY,92.0,F,Chills; headache; extreme fatigue; gas or chest pain that was thought to be gas and went away Died 4 days later,Yes,01/10/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/07/2021,1.0,PVT,"dupixent, furosemide, klor-con m10, levothyroxine, atenolol,",none,irregular heart beat,,biaxin,"['Chest pain', 'Chills', 'Death', 'Fatigue', 'Flatulence', 'Headache']",1,MODERNA,SYR 1071649,CT,91.0,F,"Acute myocardial infarction, NSTEMI, Atrial flutter, extreme weakness inability to get out of bed, headache, dizziness , nausea/vomitting,",Not Reported,,Yes,Yes,4.0,Yes,U,02/22/2021,02/23/2021,1.0,OTH,"Amlodipine, Atorvastatin, Losartan, Metoprolol, Lutein, Miralax, Xarelto",No illness. Covid vaccine #1 /29/2021,"HTN, Hyperlipidemia, CAD, Afib",,"Morphine, Oxycodone, PCN, Sulfa antibiotics, shellfish, lisinopril, dyazide, HCTZ, nifedipine","['Acute myocardial infarction', 'Asthenia', 'Atrial flutter', 'Cardiac stress test abnormal', 'Dizziness', 'Headache', 'Mobility decreased', 'Nausea', 'Troponin increased', 'Vomiting']",2,PFIZER\BIONTECH,IM 1071665,MD,82.0,M,"Patient presented to the ED for evaluation of intermittent chest pain over the past week. Initial troponin negative, patient admitted for observation. Cardiology does not believe cath is warranted at this time. Patient remains hospitalized. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,,Not Reported,,02/16/2021,03/03/2021,15.0,PVT,,,"Type 2 DM, HTN, HLD, CAD, iron deficiency anemia",,,"['Chest pain', 'Troponin normal']",2,MODERNA,IM 1071697,MD,77.0,F,"Patient presented to ED after ground-level fall. Patient appears to have not lost consciousness or pulses. PT/OT attributed fall to generalized weakness and ambulation due to chronic deconditioning. Patient to follow up with neurology for further management of severe dementia. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/05/2021,03/02/2021,25.0,PVT,,,"Depression, dementia, hypothyroidism",,,"['Asthenia', 'Dementia', 'Fall', 'Gait disturbance', 'Physical deconditioning']",1,MODERNA,IM 1071727,MD,78.0,M,"Patient presented to ED with constipation and near syncope. Patient sustained a left radial fracture after slipping on the ice a few weeks ago, and was prescribed oxycodone before and after surgery. Patient's constipation was treated with repeat enemas and stool softeners with resolution and patient is to be discharged today with daily miralax.",Not Reported,,Not Reported,Yes,,Not Reported,,02/04/2021,03/02/2021,26.0,PVT,,,"CAD, carotid artery stenosis, CVA, GERD, HTN, HLD",,,"['Constipation', 'Presyncope', 'Radius fracture']",1,MODERNA,IM 1071741,MI,83.0,M,He started vomiting 2 days later. we suspect he was having stool issues as well. he vomited blood at some point over the weekend. there was black vomit right before he passed. from 2am-6am he was wheezing and rattling and then he passed at approximately 6am 3/1/2021 at home. EMS did come and try to revive him and were unsuccessful.,Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,N,02/24/2021,02/26/2021,2.0,PHM,glimepiride 1mg Glucophage levothyroxine lisinopril Tylenol 3 with codeine fenofibrate cyclobenzaprine omeprazole,No,High Blood Pressure Prostate cancer in the past Non-insulin diabetic Coronary Artery Disease Aortic Stenosis,,No,"['Abnormal faeces', 'Breath sounds abnormal', 'Crepitations', 'Death', 'Discoloured vomit', 'Haematemesis', 'Vomiting', 'Wheezing']",1,PFIZER\BIONTECH,SYR 1071767,MD,88.0,M,"Patient presented to the ED with SOB and weakness for the past 1 month. He reports seeing his PCP twice and given antibiotics and steroids. His son also had similar symptoms to both were advised by PCP to get tested for COVID. The patient initially tested negative however, his son, who he lives with tested positive. In the ED, the patient did test positive for COVID and is assumed to have got this from his son. Patient remains hospitalized receiving remdesivir and steroids. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,,Not Reported,,02/10/2021,03/02/2021,20.0,PVT,,,"BPH, Type 2 DM, HLD",,,"['Asthenia', 'COVID-19', 'Dyspnoea', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1071771,MN,72.0,M,"Within about 10 min of vaccination, patient reported feeling shaky, weak, nauseas, and was reported to be pale. His heart rate was 120. His blood glucose was 64. Patient was admitted to the hospital for IV fluids with dextrose.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/06/2021,02/06/2021,0.0,MIL,,,,,,"['Asthenia', 'Blood glucose', 'Blood glucose decreased', 'Blood lactic acid increased', 'Haemoglobin normal', 'Heart rate increased', 'Immediate post-injection reaction', 'Laboratory test normal', 'Metabolic function test', 'Nausea', 'Nervousness', 'Pallor', 'Platelet count normal', 'Tachycardia', 'Troponin normal', 'Tryptase', 'White blood cell count increased']",UNK,PFIZER\BIONTECH, 1071775,CA,84.0,M,"First dose of covid vaccine on 2/17/2020, then hospitalized with covid disease 3/2/2020",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/17/2021,03/02/2021,13.0,PVT,"ASA, atorvastatin, citalopram, losartan, metformin, pioglitazone, tamsulosin, terazosin",none,"hx of stroke, HTN, alzheimers dementia, MGUS, GERD, DM 2, carotid disease,",,"metronidazole, hydrochloride, NSAIDs",['COVID-19'],1,PFIZER\BIONTECH,IM 1071786,CO,64.0,F,"Fever (100) and chills all night, headache, and painful injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/03/2021,03/03/2021,0.0,PUB,Amlodipine 5 mg Vitamin b Calcium,none,high blood pressure,,none,"['Chills', 'Headache', 'Injection site pain', 'Pyrexia']",1,JANSSEN,IM 1071787,KY,34.0,F,Miscarriage after 2nd dose given,Not Reported,,Not Reported,Yes,,Not Reported,Y,12/01/2020,02/01/2021,62.0,PVT,"Synthroid, Prozac, vitamin d, vitamin b complex, melatonin, guanfacine, theracurmin, prenatal vitamin, prebiotic, miralax, stool softener, pepcid",,Hashimotos,,,"['Abortion spontaneous', 'Exposure during pregnancy']",1,PFIZER\BIONTECH,IM 1071792,MD,69.0,F,"Patient presented to ED with chest pain radiating to the back, as well as left arm numbness, and lightheadedness. Patient was placed in observation unit - serial troponin negative, CTA showed no PE, mild ectasia of the distal ascending thoracic aorta. She was advised to follow up with PCP and cardiology for outpatient stress test. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/19/2021,03/01/2021,10.0,PVT,,,HTN,,,"['Angiogram pulmonary abnormal', 'Aortic dilatation', 'Chest pain', 'Dizziness', 'Hypoaesthesia', 'Pain', 'Troponin normal']",2,MODERNA,IM 1071834,KS,80.0,F,Patient woke up on 2/19/21 without the ability to verbalize to her husband. No other significant symptoms reported. Husband took her to the hospital and they admitted her. She stayed one night and was discharged the next day on 2/20/21 with complete resolution of the symptoms.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/18/2021,02/19/2021,1.0,PHM,"ATORVASTATIN, DULOXETINE",,,,NKDA,"['Aphasia', 'Computerised tomogram normal', 'Electrocardiogram normal', 'Magnetic resonance imaging normal']",1,MODERNA,IM 1071838,MD,69.0,M,"Patient presented to the ED with SOB and substernal chest pain. He was tachypneic with use of accessory muscles. He was seen by nephrology and had HD. Pt felt better after HD with no further pain and improved breathing. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/25/2021,03/01/2021,4.0,PVT,,,"ESRD (on HD), HTN",,,"['Chest pain', 'Dyspnoea', 'Haemodialysis', 'Tachypnoea', 'Use of accessory respiratory muscles']",1,MODERNA,IM 1071859,IA,36.0,F,"About 4:30, 6 hours after receiving vaccination I felt nauseated, muscle aches, horrific headache, and weak. By 6:30 I felt like my body was burning up on the inside but had no fever. My muscles in my neck became extremely tight and my ears aches. The injection site is extremely tender and hurts to lift my arm. As of 11 am the next day I have also added diarrhea to the list of symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/01/2021,03/03/2021,2.0,OTH,Pantropazol Vitamin c Calcium Zyrtec Vitamin b12 Vitamin D,None,None,,Shellfish,"['Asthenia', 'Burning sensation', 'Diarrhoea', 'Ear pain', 'Headache', 'Injection site pain', 'Muscle tightness', 'Myalgia', 'Nausea', 'Pain']",1,JANSSEN,SYR 1071863,NH,101.0,F,"Patient, age 101, was having a period of declining health prior to vaccine administration. This continued after the vaccine to include increased pain, inability to swallow and ultimately Patient passed away on 1/9/2021. The physician does not believe this is due to vaccine administration, however family asked that this information be reported for record keeping.",Yes,01/09/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/06/2021,2.0,SEN,"Ativan, Lisinopril, lasix","Dementia, health decline","chronic gout, renal impairment, ischemic cardiomyopathy",,No known allergies,"['Death', 'Dysphagia', 'General physical health deterioration', 'Pain']",1,PFIZER\BIONTECH,IM 1071869,MD,70.0,M,"Patient referred from PCP office for abnormal EKG. Patient reportedly fell on the ice and has been having chest pain since then. Case was discussed with cardiology who recommended to discharge patient home. ACS was ruled out and per cardiology, the pain was likely due to the fall. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/25/2021,03/01/2021,4.0,PVT,,,"HTN, HLD, COPD, former smoker, DJD, peripheral neuropathy, pancytopenia",,,"['Chest pain', 'Electrocardiogram abnormal', 'Fall']",2,MODERNA,IM 1071903,LA,63.0,F,No reported adverse effects after vaccine was administered. Someone reported to our clinic that patient was found dead at home on Sunday,Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,02/26/2021,02/28/2021,2.0,SCH,reported none at time of vaccination,unknown,unknown,,reported none at time of vaccination,['Death'],1,MODERNA,IM 1071904,GA,67.0,F,"I had a health physical on 11/30/2020. I had lab work on 2/01/2021. My Creatinine readings both times were in the normal range of 1. After having the Moderna injection on 2/11t2021, I had flu like symptoms on 2/12/2021. On 2/13/2021 I assumed my daily activities. On Sunday the. 14th of February around 6PM, I became very weak. I could only get out of bed to use the restroom. I was to weak to do my normal activities. I was bed ridden for the next 11days. On 2/22/2021, I went to Medical Practice. They treated me and sent me home. On the 25th of February at or around 5PM, I went to Hospital. My Creatinine number was 9 and they admitted me. Eventually i was diagnosed with Kidney Failure.",Not Reported,,Yes,Yes,8.0,Yes,N,02/11/2021,02/14/2021,3.0,PVT,"Pregabalin, 0xycodone & Prevacid",Sinusitis Infection,"IBS, Gerd &Bursitis",,"Sulfonamioe, Erythromycin, Penicillin & Salicylate","['Asthenia', 'Blood creatinine increased', 'Influenza like illness', 'Mobility decreased', 'Renal failure']",2,MODERNA,SYR 1071922,OR,42.0,F,Expanding red raised rash at injection site that grew until I had an anaphylactic event. It is unknown if it is due to the vaccine due to it taking 3 days to happen but I strongly suspect it. Taken by ambulance to hospital and epinephrine.,Not Reported,,Yes,Not Reported,,Not Reported,N,02/28/2021,03/01/2021,1.0,PVT,"Humalog, Lantus, iron, sertraline, wellbutrin, met for in, gabapentin, albuterol, lisinopril",None,"Diabetes, osteoarthritis, asthma, pcos",,"Sulfa, penicillin, mold","['Anaphylactic reaction', 'Blood test normal', 'Injection site reaction', 'Rash erythematous', 'Rash papular']",2,MODERNA,SYR 1071929,NV,63.0,F,"It was the Pfizer Vaccine. I received the vaccine at 11:30 am Sunday. At approximately 3:30 pm I started having a lot of pain in my legs (calves and feet) at first it was extreme pain that led to tingly prickly sensations. I went home, went to bed, was up all night in bed groaning because of the pain, and when I tried to stand, was unable to. I crawled to my phone and called my sister (who lives next door) who ran over. She has a wheelchair and took me to the hospital. I was unable to walk alone for four days and the pain was not as extreme after 5 days. I am now 3 weeks out and still have numbness in my legs.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/07/2021,02/07/2021,0.0,PVT,Co Q 10 Daily Aspirin Escapalotram Buproprion Vitam D Vitamin A,None,None,,None,"['Blood test', 'Dysstasia', 'Gait disturbance', 'Hypoaesthesia', 'Moaning', 'Mobility decreased', 'Pain in extremity', 'Paraesthesia', 'Ultrasound scan']",1,PFIZER\BIONTECH,SYR 1071935,IA,28.0,M,"Patient received the vaccine around 11 am. He hadn't been feeling well (headache, dizziness) per report and initially called in to work. He then decided to come to work and was found down in a patient bathroom during his shift on our Facility while taking care of a patient (he was a nurse aid). Patient was coded and the team and was transferred to our Facility ED. He expired 3/3 2112",Yes,03/03/2021,Not Reported,Not Reported,,Not Reported,N,03/03/2021,03/03/2021,0.0,PUB,"Metoprolol ER 50 mg qHS, Trazodone 50 mg qHS, Lisinopril 40 mg daily, HCTZ 25 mg daily, Topiramate 25 mg qHS, Melatonin 1 tab qHS, Bupropion 300 mg daily","HTN, sleep apnea","HTN, sleep apnea, hx of MRSA wound infection in groin",,Penicillin,"['Cardio-respiratory arrest', 'Death', 'Dizziness', 'Fall', 'Headache', 'Malaise', 'Weight increased']",1,PFIZER\BIONTECH,IM 1071945,NC,77.0,F,Massive stroke causing Left hemiplegia,Not Reported,,Not Reported,Yes,10.0,Yes,N,02/12/2021,03/03/2021,19.0,PVT,,,"Heart related condition , High blood pressure",,NKA,"['Cerebrovascular accident', 'Hemiplegia']",2,MODERNA,SYR 1071952,,56.0,M,"LEFT ARM SEVERE PAIN, NUMBNESS, NEUROPRAXIA",Not Reported,,Not Reported,Not Reported,,Yes,N,02/13/2021,02/27/2021,14.0,PVT,none,none,HTN,,none,"['Computerised tomogram head', 'Electrocardiogram', 'Hypoaesthesia', 'Nerve injury', 'Pain in extremity']",2,MODERNA,IM 1071969,WI,51.0,M,"Headache and nausea starting 5:30am 15 Jan with exertion. Same symptoms on 16 Jan, 17, and 21 Jan with sexual activity. BP started to be in 150-160/110 range (used home BP cuff) on 19 Jan. No neurological deficits. Presented to ER on 21 Jan with c/o headache an d nausea. BP was 160+/110+. CT scan showed SAH. Transferred to hospital for eval. Was in neurosciences ICU x 1 night and neuro ward x 2 nights. Discharged on 24 Jan. DSA and MRA showed no AVM or aneurysm. LP showed no inflammatory or infectious process. CBC WNL. PT/PTT WNL. Lipids showed hyperlipidemia. Working diagnosis is Reversible Cerebral Vasoconstriction Syndrome.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/11/2021,01/15/2021,4.0,MIL,"Lisinopril 40mg daily, multivitamin, Omeprazole 20mg , Ibuprofen 800mg prn back pain",None,"HTN, chronic LBP, hx of subdural hematoma (trauma), hx of cataracts b/l, GERD",,NKA,"['Angiogram cerebral normal', 'Angiogram normal', 'Computerised tomogram head abnormal', 'Exertional headache', 'Full blood count normal', 'Hyperlipidaemia', 'Intensive care', 'Lipids abnormal', 'Lumbar puncture normal', 'Nausea', 'Primary headache associated with sexual activity', 'Prothrombin level normal', 'Prothrombin time normal', 'Reversible cerebral vasoconstriction syndrome', 'Subarachnoid haemorrhage']",1,MODERNA,IM 1071993,NC,62.0,F,Patient was complaining of increased heart rate and nausea about 20 minutes following the vaccine. Patient also mentioned she had just had blood work done that morning before coming to get her vaccine so the pharmacy staff gave her some bottled water. Patient requested an ambulance and wanted to be transported.,Not Reported,,Not Reported,Yes,,Not Reported,U,03/04/2021,03/04/2021,0.0,PHM,Unknown: did not list on database,None,None,,None,"['Heart rate increased', 'Nausea']",1,PFIZER\BIONTECH,IM 1071998,CA,40.0,M,Received first dose of Moderna vaccine on Tuesday 2/23/2021 and began to feel tingling on the right side of my head and an ear ache the next day (Wednesday 2/24/2021). The symptoms got progressively worse over the next few days and on Sunday 2/28/2021 the right side of my face was completely paralyzed. I sought emergency care at Hospital Emergency Room where I was diagnosed with Bells Palsy. The doctor who treated me strongly believes that the Bells Palsy was due to the Moderna vaccine. Today (9 days post vaccine) the entire right side of my face continues to be completely paralyzed with no signs of improvement.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/23/2021,02/24/2021,1.0,WRK,NONE,NONE,NONE,,NONE,"['Adverse reaction', ""Bell's palsy"", 'Ear pain', 'Facial paralysis', 'Paraesthesia']",1,MODERNA,SYR 1072001,MD,88.0,F,"Patient presented to the ED with generalized weakness and urinary symptoms. Urine culture grew E coli, patient was treated with ceftriaxone which was later transition to cefdinir at discharge. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/25/2021,02/28/2021,3.0,PVT,,,"HTN, HLD, hx of CVA, anemia",,,"['Asthenia', 'Culture urine positive', 'Enterocolitis', 'Escherichia infection', 'Escherichia test positive', 'Genitourinary symptom', 'Lower urinary tract symptoms']",2,MODERNA,IM 1072006,,67.0,M,Individual reported workplace exposure to COVID-19. Patient experienced fever/fatigue being the evening of 2/12/2021.,Not Reported,,Not Reported,Yes,,Not Reported,Y,02/08/2021,02/13/2021,5.0,WRK,,,,,,"['Exposure to SARS-CoV-2', 'Fatigue', 'Pyrexia']",1,PFIZER\BIONTECH, 1072012,KY,72.0,M,Breakthru Covid- 19 infection,Not Reported,,Not Reported,Yes,9.0,Not Reported,N,12/30/2020,02/24/2021,56.0,SEN,,NEOPLASM OF THE LUNG CHRONIC ANEMIA LEUKOPENIA,SAME AS ABOVE,,NKDA,"['COVID-19', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1072016,MN,63.0,F,About 9 PM headache started and I had that until Saturday morning. I don' t get headaches that often so it was unusual. I took Tylenol - which helped. I was admitted to the hospital for February 8 for bronchitis. About the fourth of February is when I started getting symptoms of this. I was in the hospital from the 8-10th. Hospital. Bronchitis resolved around the 20th of February.,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/28/2021,01/28/2021,0.0,PVT,Humalog insulin; Tresiba insulin; Trazadone; Seroquel,adverse symptoms after dose 1 Pfizer vaccine;,diabetes; depression; arthritis,with the first Shingles vaccination - January 2020 - I had extreme swelling in my arm that went into armpit and body aches for a,Codeine; amoxicillin; Lanolin; roses; bee sting - have had anaphylactic reaction to bee sting,"['Bronchitis', 'Chest X-ray abnormal', 'Dehydration', 'Headache']",2,PFIZER\BIONTECH,SYR 1072024,MD,82.0,M,"Patient presented to the ED with increased SOB. During his admission he was noted to likely have diastolic HF (to follow up with cardiologist for stress test), COPD and suggested pulmonary HTN, as well as cirrhosis of unclear etiology. Patient was treated with diuretics, steroids, and antibiotics and was later discharged. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,3.0,Not Reported,,02/24/2021,02/28/2021,4.0,PVT,,,"COPD, cor pulmonale, recent STEMI, HTN",,,"['Chronic obstructive pulmonary disease', 'Condition aggravated', 'Dyspnoea', 'Hepatic cirrhosis', 'Left ventricular failure', 'Pulmonary hypertension']",1,PFIZER\BIONTECH,IM 1072113,,44.0,M,Death,Yes,02/16/2021,Yes,Yes,,Not Reported,N,02/12/2021,02/14/2021,2.0,PUB,,,,,,['Death'],UNK,PFIZER\BIONTECH, 1072120,MD,88.0,F,"Patient presented to ED with SOB for 2 weeks. Patient was treated with IV Lasix. Cardiology suspected heart failure exacerbation and patient was discharged home. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/25/2021,03/01/2021,4.0,PVT,,,"HTN, CAD",,,"['Cardiac failure', 'Condition aggravated', 'Dyspnoea']",2,PFIZER\BIONTECH,IM 1072156,CA,68.0,M,"Vaccine manufacturer and lot number unknown, vaccine given at alternate location. 2/23/21 8:27 PM: The patient is a 68-year-old male comes to the emergency department by paramedic ambulance for altered mental status that, began at around noon in association fever temp 102.9. PMH of myelofibrosis (on Jakafi and hydroxychloroquine), depression, anxiety, OSA, and history of AVR. Given history of myelodysplasia and Jak inhibitor predisposing to some opportunistic infections most notably viral reactivation with history of HSV and possible bacterial endocarditis he was admitted to the ICU for further monitoring and pressors. Patient has a MOS procedure 14 days prior - Status post MOSs procedure with large wound deficit on forehead -- Does not appear to be overtly infected at the time of admission. ED physician indicated mild facial cellulitis. 2/23/21- WBC 16.1 on admission. ECHO 2/26 indicated - no vegetation visualized. Of note second COVID vaccine 2 days prior to admission. Dr. felt incident was possible cardiogenic shock secondary to COVID vaccine. He did not feel the patient has a source of infection upon admission. Questionable given wounds on forehead Dr. (CMO) review of case- his impression was septic shock with and underlying case of chronic cardiac compromise making the hemodynamics worse",Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/23/2021,1.0,PVT,allopurinol 300mg daily aripiprazole 5mg daily cephalexin 500mg q12h cholecalciferol 2000 units daily hydroxychloroquine 200mg 2x daily levothyroxine 125mcg daily presnisone 5mg daily ruxolitinib 15mg 2x daily sertraline 100mg daily valacyc,erythema of face consistent with mild cellulitis recent MOS procedure for skin cancer,"myelofibrosis History of aortic valve replacement in 2014 hx of depression, anxiety",,"amiodarone, doxycycline, penicillin","['Anxiety', 'Blood culture negative', 'Cardiac disorder', 'Cardiac failure', 'Cellulitis', 'Culture urine negative', 'Culture wound negative', 'Depression', 'Echocardiogram', 'Haemodynamic instability', 'Intensive care', 'Mental status changes', 'Postoperative wound infection', 'Pyrexia', 'Septic shock', 'Sleep apnoea syndrome', 'White blood cell count increased']",UNK,MODERNA, 1072166,VT,87.0,M,Patient hospitalized with shortness of breath and pneumonia (from 2/15/2021 to 2/21/2021) and patient died at another facility on 3/2/2021.,Yes,03/02/2021,Not Reported,Yes,6.0,Not Reported,N,02/09/2021,03/02/2021,21.0,PVT,"amlodipine, atorvastatin, betamethasone topical, carvedilol, clobetasol topical, furosemide, losartan, mycophenolate mofetil, nitroglycerin, pantoprazole, potassium chloride, rivaroxaban, tamsulosin, triamcinolone topical",paraviral pneumonia,"atrial fibrillation, bladder cancer, aortic dissection, hypertension, spinal cord stroke",,None,"['Death', 'Dyspnoea', 'Pneumonia']",1,PFIZER\BIONTECH,IM 1072189,WA,68.0,F,"Started dry cough for three day, pain across the lower back began two days after cough. Began intense pain with nausea and cold and clammy sweats. Called the nurse on my insurance who advised to get to the ER.",Not Reported,,Yes,Yes,3.0,Not Reported,N,02/15/2021,02/16/2021,1.0,PVT,Placid and vitamin D3,None,"June 28 2020, insertion of stents into left femoral artery and popliteal behind knee cap.",,None,"['Back pain', 'Cold sweat', 'Cough', 'Feeling cold', 'Hyperhidrosis', 'Intensive care', 'Magnetic resonance imaging thoracic abnormal', 'Nausea', 'Pain', 'Pulmonary embolism', 'Thrombosis']",1,MODERNA,IM 1072191,MD,70.0,F,"Patient was admitted due to having a syncopal or near syncopal episode while dry heaving. She was found to have a probable gastric outlet obstruction and an NG tube was placed initially. She is being followed by general surgery and GI, underwent EGD which showed duodenitis. Pt's diet has progressed to full liquid. She remains in the hospital at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,,Not Reported,,02/19/2021,02/25/2021,6.0,PVT,,,,,,"['Duodenitis', 'Gastrointestinal tube insertion', 'Obstruction gastric', 'Oesophagogastroduodenoscopy abnormal', 'Presyncope', 'Retching', 'Syncope']",2,PFIZER\BIONTECH,IM 1072193,HI,43.0,F,"eight minutes after the vaccine I was waiting for my after dose evaluation, I started feeling numbness on left side of my face, I was taken to the ER, it went down to the left side of my neck and my left arm, after an hour I couldn't move the entire left side of my body, they did an MRI and admitted me to overnight observation. next morning I was discharged (friday), physical therapy and occupational therapy came in to help me adjust because I was still numb I was given a walker and a knee brace, I went home. Saturday I started getting feeling in my face and neck. Sunday I was still gaining more sensation, Monday I had full sensation every where except my leg, Tuesday I had complete feeling on my entire left side. 7 days after my shot on wednesday I started having cold chills body aches and fever nausea and diarrhea, by thursday I couldn't eat anything in me I would have diarrhea. I went to the ER on Saturday, they ran tests CT scan and found entera colitis and was admitted again, they started me on iv antibiotics and fluids , no solid food, they tested my stool and everything came back normal. I was discharged because the diarrhea had stopped, I was having regular bowl movements. Dr said it may or may not have been a cause from the vaccine, they weren't sure.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/14/2021,03/04/2021,49.0,PVT,blood pressure pills,no,"high pressure, diverticulosis","Covid dose 1 - numbness on part of left side of body, 12/23/2020",Vicodin,"['Chills', 'Computerised tomogram abnormal', 'Diarrhoea', 'Enterocolitis', 'Feeding intolerance', 'Hemiplegia', 'Hypoaesthesia', 'Magnetic resonance imaging normal', 'Mobility decreased', 'Nasopharyngitis', 'Nausea', 'Pain', 'Pyrexia', 'Walking aid user']",2,PFIZER\BIONTECH,SYR 1072218,VT,82.0,M,Patient hospitalized for NSTEMI (from 2/18/2021 to 2/20/2021) and discharged on hospice/comfort care. Patient died 2/21/2021.,Yes,02/21/2021,Not Reported,Yes,2.0,Not Reported,N,02/13/2021,02/21/2021,8.0,PUB,"aspirin, atorvastatin, clotrimazole topical, gabapentin, lisinopril, metoprolol, docusate, multivitamin, nitroglycerin, omeprazole, probenecid, triamcinolone topical, zolpidem",,"angina pectoris, coronary artery disease, epistaxis, gout, hyperlipidemia, hypertension, idiopathic pulmonary fibrosis, lymphoma",,None,"['Acute myocardial infarction', 'Death']",1,PFIZER\BIONTECH,IM 1072223,TX,84.0,F,"Site: Pain at Injection Site-Mild, Systemic: Stroke-Severe",Not Reported,,Not Reported,Yes,20.0,Not Reported,N,02/08/2021,02/20/2021,12.0,SEN,,,,,,"['Cerebrovascular accident', 'Injection site pain']",2,PFIZER\BIONTECH,IM 1072224,MD,81.0,M,"Patient presented to ED with SOB. Of note, had recent kyphoplasty. Patient reports fever, productive cough, and sore throat as well as fatigue. Patient found to have post-operative pneumonia and was treated with antibiotics. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,3.0,Not Reported,,02/19/2021,02/25/2021,6.0,PVT,,,"asthma, type 2 DM, HTN, HLD, GERD, OSA, kidney stones, stage III CKD",,,"['Dyspnoea', 'Fatigue', 'Oropharyngeal pain', 'Pneumonia', 'Productive cough', 'Pyrexia']",2,MODERNA,IM 1072527,FL,,U,"Episode of angioedema; A spontaneous report was received from a healthcare professional concerning two patient's who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an episode of angioedema. The patients' medical histories included both patients receiving dermatological fillers. No relevant concomitant medications were reported. On unknown date, prior to the event , both patients received their first of two planned doses of mRNA-1273 intramuscularly of prophylaxis of COVID-19 infection. On an unknown date, after vaccine administration, both patients experienced an episode of angioedema. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, episode of angioedema, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The Patient's history of having dermatological fillers could be a contributing factor. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Dermal filler injection,,,['Angioedema'],1,MODERNA,OT 1072528,NY,82.0,F,"Atrial fibrillation; elevated diastolic blood pressure; A spontaneous report was received from a consumer, who is a 82-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sustained atrial fibrillation and elevated diastolic blood pressure. The patient's medical history or concomitant medications were not provided. On 12-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (037M20A) intramuscularly in an unknown anatomical location for prophylaxis of COVID-19 infection. On 14-Feb-2021, the patient experienced the sustained atrial fibrillation and elevated diastolic blood pressure, which were considered medical significant. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event was unknown. The patient believe the events, sustained atrial fibrillation and elevated diastolic blood pressure, may be related to the vaccine. Consent given for Safety Division to follow up with her, if needed.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/14/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Atrial fibrillation', 'Blood pressure diastolic increased']",1,MODERNA,OT 1072529,NY,57.0,F,"Fainted; dizziness; All night she was sick; Chills; Aches; A spontaneous report was received from a consumer concerning a 57 years old, female patient who experienced chills, aches, dizziness, fainted and was sick all night. The patient's medical history was not provided. Concomitant products included cetirizine and an unspecified nasal spray for allergies. On 20-JAN-2021 the patient received their first of two planned doses of mRNA-1273 (Batch number: 012120A) on 20-JAN-2021. On 17-FEB-2021, approximately one day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number 016M20A) for prophylaxis of COVID-19 infection. On 17-FEB-2021, the patient was sick for all night, on the same day patient experienced chills and aches. On 18-FEB-2021, the patient had dizziness and fainted. Treatment information was not provided/unknown. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The events, chills, aches, dizziness, was sick all night were considered unknown. The event, fainting, was recovered on 18-FEB-2021.; Reporter's Comments: This case concerns a male of unknown age who experienced a serious unexpected event of SYNCOPE along with NS unexpected events of dizziness, illness, pain, and a NS expected event of chills. The events occurred 45 minutes after the first dose of mRNA-1273. Syncopal event reported as resolved, but other event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,02/17/2021,28.0,UNK,ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Chills', 'Dizziness', 'Illness', 'Pain', 'Syncope']",1,MODERNA,OT 1072530,WA,,M,"Thrombocytopenia; A spontaneous report was received from a NURSE, concerning a 74-Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced thrombocytopenia. The patient's medical history was not provided. No relevant concomitant medications were reported. On 25-Jan-2021, prior to the onset of the events, the patient received their first planned dose of mRNA-1273 (lot/batch: 042L20A) for COVID-19 infection prophylaxis. On an unspecified date in 2021, the patient experienced the event thrombocytopenia and presented to emergency room and was hospitalisation on an unspecified date in 2021. His platelets dropped down to 2. The event was also considered to be medically significant. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event was considered unknown. The reporter assessed the event thrombocytopenia as related to study drug.; Reporter's Comments: Very limited information regarding this event of thrombocytopenia has been provided at this time. onset date of event, patient's medical history full blood count results with reference ranges are lacking. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/25/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Platelet count decreased', 'Thrombocytopenia']",1,MODERNA,OT 1072531,NJ,,F,"UTI; Fall; A spontaneous report was received from a consumer (caregiver) concerning a 93 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced urinary tract infection (UTI) and fall. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the UTI and fall. The patient is currently in a rehab facility due to the fall. The patient received treatment medication with unspecified antibiotics for the UTI. The patient was re-scheduled for the second vaccine on 12 Mar 2021, which falls outside the 42-day timeframe (which would be 49 days after the first vaccine). No further information was provided. Action taken with second dose of mRNA-1273 in response to the events was unknown. The outcome of the events, UTI and fall, were not reported.; Reporter's Comments: This case concerns a 93 year old, female patient, who is in a rehab facility due to fall, experienced a serious unexpected event of urinary tract infection, after receiving mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Fall', 'Urinary tract infection']",1,MODERNA,OT 1072532,UT,,M,"Aspirated some vomit in lungs; Light-headed; Vomited; Nausea; Soreness; Tired; A spontaneous report was received from a consumer who was also a 94-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness, tiredness, vomiting, aspiration, lightheadedness, and nausea. The patient's medical history included major depression. Concomitant medications included fluoxetine 5 mg and celecoxib 200 mg. On 08-feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 8411201) for prophylaxis of COVID-19 infection. On 08 Feb 2021, the patient began to experience soreness following vaccination. Soreness resolved within half an hour. The patient also reported feeling tired. On 18 Feb 2021, the patient experienced vomiting, lightheadedness, and nausea. He felt as if he aspirated some vomit into his lungs. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The events, soreness and vomiting, were considered resolved on 18 Feb 2021. The outcome of events, lightheadedness, aspiration, nausea, and tiredness, was unknown.; Reporter's Comments: This case concerns a 94-year-old male who experienced Serious unexpected events of Aspiration along with NS unexpected events of dizziness, pain and NS expected events of nausea, vomiting, fatigue. The events occurred 11 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes recovered. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,UNK,FLUOXETINE; CELECOXIB,Major depression,,,,"['Aspiration', 'Dizziness', 'Fatigue', 'Nausea', 'Pain', 'Vomiting']",1,MODERNA,OT 1072533,AL,,M,"Doesn't feel well; Heart rate 97; Blood pressure went to 150/91 at 6pm, at 7pm 192/101; Heart rate fluctuating; Fatigued; A Spontaneous report was received from Consumer concerning a 77-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Blood pressure went to 150/91 at 6pm, at 7pm 192/101, heart rate 97/elevated heart rate or his heart rate was fluctuating, was fatigued and he did not feel well. The patient's medical history included prostate cancer and bone cancer. The concomitant medication was not reported. On 20-Jan-2021 prior to the onset of the event, the patient received their first dose mRNA-1273 (Lot number: 030L20A, Expiration date: not provided), on 17-Feb-2021 second dose was received at 9:00 am (Lot number: 030M20A, Expiration rate: unknown) via intramuscular route for prophylaxis of COVID-19 infection. On 17-Feb-2021, after administration of vaccine patient experienced Blood pressure went to 150/91 at 6pm, at 7pm 192/101, heart rate 97/elevated heart rate or his heart rate was fluctuating, was fatigued but was not sure if that was part of the vaccine or heart medication. On an unknown date patient did not feel well. Action taken with the mRNA-1273 in response to the events was not provided. The outcome was unknown for all events. Treatment was included Clonidine 0.2ml.; Reporter's Comments: This case concerns a 77 Y/O M with PMHx of prostate cancer and bone cancer who had serious unexpected Blood pressure increased and Heart rate increased along with a NS unexpected Heart rate irregular, malaise, and NS expected fatigue. Event onset 29 days after first dose mRNA-1273. Treated with clonidine. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,02/17/2021,28.0,UNK,,Bone cancer; Prostate cancer,,,,"['Blood pressure increased', 'Blood pressure measurement', 'Fatigue', 'Heart rate', 'Heart rate increased', 'Heart rate irregular', 'Malaise']",1,MODERNA,OT 1072534,,,M,"Got senior delirium syndrome; Very sick; A spontaneous report was received from a consumer who was also a male patient, unknown age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced senior delirium syndrome(delirium) and was very sick (illness). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unspecified date, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date the patient received vaccine and experienced the senior delirium syndrome and patient was very, very, very sick and patient was hospitalized for events. Treatment information was not provided. Action taken with the drug in response to the events is not applicable as the patient received both scheduled doses of mRNA-1273 prior to the events The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Delirium', 'Illness']",2,MODERNA,OT 1072535,NC,67.0,F,"Could have died with a blood pressure with these numbers; Blood pressure had spiked up to 235/104; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN9581), via an unspecified route of administration in the left arm on 09Feb2021 at 13:00 at 67-years-old at a single dose for COVID-19 immunization. There were no additional vaccines administered on the same date of Pfizer suspect. The patient did not receive any prior vaccinations within 4 weeks of the Pfizer suspect vaccine. Medical history included blood pressure increased (BP raised) in Sep2020 (BP reading was 135/80). There were no concomitant medications. The patient experienced: ""could have died with a blood pressure with these numbers"" (medically significant, life threatening) on an unspecified date, and blood pressure had spiked up to 235/104 (medically significant, life threatening) on 11Feb2021 at 16:30. The clinical course was reported as follows: The patient reported that she was a healthy person; and she had never had blood pressure problems before (as reported). The patient also reported that she was ""on no medications whatsoever."" Five months ago (from the time of the report), the patient had a wellness exam. The patient's ""blood pressure was perfect."" It was reported that ""everything was perfect"" with her health exam five months ago. Five months prior, the patient's BP reading was 135/80. The patient thought that the COVID vaccine was very dangerous and she was unaware that hypertension could even be a side effect. The patient received the vaccine on 09Feb2021, and she ""got a long fine while waiting at the facility."" Two days later, on 11Feb2021, the patient took her blood pressure and she could not believe the reading. The patient then went to a pharmacy and had the pharmacist take it for her because she thought ""she was crazy""; and because she thought her machine was not right. The patient's blood pressure had spiked up to 235/104. When the pharmacist took her blood pressure, they told her she needed to go to the ER immediately. The patient was informed her blood pressure was beyond stroke level; therefore, she was rushed to the ER and was given IV BP medications to try and get her blood pressure down. The patient was released to home. The patient, after she went to the ER the first time, she was told to go see her primary care the following day. Two days later she was back in the ER with spiked blood pressure on 13Feb2021. The patient's blood pressure on 13Feb2021 was 224/84. The patient was again treated and released. The patient stated that she saw who she believed was a physician assistant (PA). The patient was started on a blood pressure medication as well; and her last and most recent blood pressure reading was 144/85. The patient reported that the she was prescribed hydrochlorothiazide. After the patient's first ER visit, she was prescribed 12.5mg once a day. However, after the second ER visit, she had a blood pressure spike and the dose was increased to 25mg once a day. The patient received the paper with side effects, and she had none of the side effects listed; ""none, whatsoever."" The patient read that the more severe side effects were difficulty breathing, fast heartbeat, rash, dizziness. The patient further stated that ""under that, it was list serious and unexpected side effects may occur""; this was where the patient felt like her situation come in. It was serious and unexpected. The patient reported that she was upset; and felt that she could have died with a blood pressure of those numbers. The patient reported that she was a healthy person and she was looking forward to getting the vaccine. The patient stated she would not be getting the second vaccine. The patient wished she just had the normal listed side effects such as arm soreness, joint pain, fever, headache; however, she did not experience any of those events. The patient felt that if she did not check her blood pressure at home on her own, she would not have known her blood pressure was that high. The patient then added she had spoken to a couple of doctors and they had a total of five cases that were very similar to hers and had to be treated. The patient underwent lab tests and procedures which included blood pressure: spike on an unspecified date, blood pressure: 135/80 in Sep2020, blood pressure: 235/104 on 11Feb2021, blood pressure: 224/84 on 13Feb2021, blood pressure: 144/85 in Feb2021, health exam: everything was perfect on an unspecified date. Therapeutic measures were taken as a result of the events. The clinical outcome of the events was unknown. Adverse events following prior vaccinations: None. The patient did not remember getting any other vaccinations.",Not Reported,,Yes,Not Reported,,Not Reported,U,02/09/2021,02/11/2021,2.0,UNK,,,Medical History/Concurrent Conditions: BP raised (BP reading was 135/80),,,"['Blood pressure increased', 'Blood pressure measurement', 'Investigation', 'Near death experience']",1,PFIZER\BIONTECH, 1072536,SC,70.0,F,"severe asthma; trouble breathing; might have the coronavirus; My face is blood red; I am worried; Wheeze; she is also shaky; general malaise; heart attack; and last night she drank some water and choked on it then couldn't get her breath and; chest was hurting radiating to my arm down; fever; chills; exhausted/just felt very tired; her arm that was sore was the one where she had her injection; This is a spontaneous report from a contactable consumer (patient). A 70 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EM9810), via an unspecified route of administration (on left arm) on 15Feb2021 (at the age of 70 -years-old), single dose for COVID-19 immunization. Medical history included asthma, sleep apnea, thyroid problem, prediabetes, cpap use, all from an unknown date. There were no concomitant medications. Patient reported her face is blood red. Last night her chest was hurting radiating to my arm down. It felt like someone was strangling her with water. She noticed my symptoms were what people experience after receiving the second dose. She had fever, chills, exhausted and just felt very tired after receiving the first dose. She still have trouble breathing. She had severe asthma. She was not breathing normally. When she put the mask on it's even harder to breath. She was worried. She thinks, she might have the coronavirus. Consumer says that she is still not feeling well after receiving her first dose of the Pfizer COVID-19 vaccine on February 15th. She says that the first day after getting it, she had pain in her arm, it was achy, it was not really painful enough to where she had to take Tylenol for it. She says yesterday on the second day she had fever, chills, tiredness, general malaise, and today she is not feeling well. Caller says she was having trouble breathing, and did a treatment with her nebulizer which she has because she has real bad asthma. She says her breathing is labored and she wheezes every once in a while. She says she would like to see if there is anything that she needs to do, because she works with children, and if she is coming down with the corona virus she doesn't want to be around them with it. She says that her breathing is problematic today. She says she doesn't think that she is having a severe reaction, she has no rash or those kind of symptoms. She says it seems to be just the asthma, and last night she drank some water and choked on it then couldn't get her breath and her chest hurt and she had pain down her arm and thought oh gosh she was having a heart attack.Caller says she has done no treatments other than the nebulizer treatment. No further details provided about the nebulizer treatment. Caller says the provider said no Tylenol right away, so she didn't take any yesterday with her fever, and she didn't have a thermometer to take her temperature, but her face was really hot and she was having chills, which usually means she has a fever. She says that her arm that was sore was the one where she had her injection. She says that never really was that bad, everyone said their arm had ached, and she has a high pain threshold so it never bothered her. Her wheezing and little trouble breathing was better, after she did some breathing treatments with the nebulizer, she is not breathing well but she is breathing better. She says she is also shaky and doesn't know if that is just nerves, or if this is also something going on. Caller says that it has been a while since she had blood work, which was the last time she went to see physician, but she doesn't know the results for what they found out. The outcome of the events Breathing difficult,wheeze was recovering, other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/16/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Asthma; CPAP (cpap use); Prediabetes; Sleep apnea; Thyroid disorder,,,"['Anxiety', 'Asthma', 'Blood test', 'Body temperature', 'Chest pain', 'Chills', 'Choking', 'Coronavirus infection', 'Dyspnoea', 'Erythema', 'Fatigue', 'Malaise', 'Myocardial infarction', 'Nervousness', 'Pyrexia', 'Vaccination site pain', 'Wheezing']",1,PFIZER\BIONTECH, 1072537,NJ,71.0,M,"noticed diminished hearing in the right ear/couldn't hear a tick at all; he felt fullness in his right ear; sore left arm where he got injection; This is a spontaneous report from a contactable physician (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9809, expiry date: unknown), via an unspecified route of administration on 10Feb2021 12:30 (at 71-year-old) at single dose (left arm) for COVID-19 immunization. Medical history included hypertension (mild hypertension and it is well controlled, it was diagnosed 5-6 years ago), hyperlipidemia (mild hyperlipidemia and it is well controlled, it was diagnosed 5-10 years ago). He stated in Aug, he tested positive for antibodies through Lab and was still positive a month later. He wondered how that might effect the decision of if he should get the second dose, if he is potentially immune. He had no symptoms but tested negative with PCR test. His girlfriend who he lives with tested negative for antibodies. Height was reported as 6 feet to 6 feet one inch tall. Weight was reported as 176-178lbs, he thought he may have gained a few pounds. There were no concomitant medications. The caller had the first dose of the vaccine 10Feb2021 12:30. 5 days later he felt fullness in his right ear (Feb2021) and noticed diminished hearing in the right ear (Feb2021), maybe 20-30% less. He was comparing how much he could hear the ticking of his watch in his left and right ear and couldn't hear a tick at all. He went to an ENT and they found that it was reduced in the right ear secondary to a nerve problem and wasn't secondary to anything else. The doctor read online on an ENT site, a couple of people had acute bouts of decreased hearing. They were treated with steroids and resolved. His provider prescribed him with a high dose of steroids, 70 mg. He was going to take it after dinner but all of the sudden he could hear the ticking better. He held off on taking the steroid and the next morning his hearing was fine. He went back and they retested and it was back to normal. He had taken Naprosyn and is not sure if that played a part in improving things. It resolved not even 24 hours after the initial symptoms. It resolved on its own. He asked, is this a side effect that has been reported? Are there any cases of this happening in one ear rather than 2? Could it be a contraindication getting the second dose? His doctor is researching it and he is supposed to call early next week about this. He asked how many people were in the clinical trials that the side effect data is based on. The caller stated he heard someone report that he doesn't believe that people getting the vaccine necessarily need both doses of the vaccine. They are finding after a week after the first dose they have relative immunity and might not need the second dose. The caller asked how effective this vaccine might be on new variants, how effective just one dose of the vaccine is, if Pfizer is looking into mixing the vaccines- whether it will be something that can be interchanged with other Covid-19 vaccines, asked where he could find updates on medical information about this in the future. The caller stated he wanted to thank Pfizer for developing the vaccine as quickly as they did. Retired psychiatrist calling about Pfizer COVID-19 vaccine who says he got his first dose on 10Feb in (State name), and had a sore left arm where he got the injection (Feb2021) then 5 days later had fullness in his right ear with his hearing diminished. He says he called his otolaryngologist because he had had a hearing test a few months ago, and was tested again now and there was a moderate decrease of hearing in his right ear. He says he would like to know if this could be a possible side effect, since he has read of reports and his otolaryngologist knew of two reports where people did report hearing loss. He says that he was treated acutely with steroids at high dose of 70mg for which he filled the script, then called his internist who was ambivalent with him taking a high dose. Caller says then within a few hours, his hearing was better, and by the next morning it was normal, and he went back to the ENT and his hearing was the same as it was a few months ago. He says he did not take the steroid he was prescribed, the Prednisone, he took Naproxen, and since it may have been a nerve problem with hearing diminished related to auditory nerve, it seemed to get better in a number of hours. He says he has reported this already to VAERS. Caller says his right ear is better now, it got better within a a few hours after he saw his doctor, then it was completely better by the next morning. He says that after they tested his hearing due to the fullness in his ear and hearing being diminished it got better on its own. He says on the next hearing test his hearing was exactly back to normal. He says he did take Naproxen once or twice during that time period, 20 or less hour period, more like 12 hours, one 220mg tablet each time, he doesn't know whether that contributed to helping. Naproxen (EXP Jan2022, LOT: ODRO445). He says that the reason he is calling is to see whether Pfizer has had similar reports. He says that he saw on a website that 12 people were reporting deafness or blindness, but it seemed to be an (name), so he took it with a grain of salt. He says he would like to know whether people have been reporting with issues for hearing, unilaterally or bilaterally, or what results have been with some people. Caller says unfortunately the website he mentioned was obviously anti vaccine and claimed to be with the (name) or version of the CDC and said that they were reporting they had 12 people reporting deafness and blindness from COVID vaccine and made it sound like the most dangerous vaccine in the world, but it was a conspiracy website that claimed it was with the equivalent of CDC. Caller does not have website addresses to provide or details about reports on that site. Caller says he looked at the (name) and it said nothing about this kind of possible side effect. He says he doesn't know if his could be related to getting the vaccine, or if he should still get a second dose of the vaccine. The outcome of the event ""noticed diminished hearing in the right ear/couldn't hear a tick at all"" and ""he felt fullness in his right ear"" was recovered in Feb2021, while for other event was unknown.; Sender's Comments: Based on available information the reported unilateral deafness was unlikely related to bnt162b2. This was an intercurrent medical condition. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/10/2021,02/01/2021,,UNK,,,"Medical History/Concurrent Conditions: Hyperlipidemia (mild hyperlipidemia and it is well controlled, it was diagnosed 5-10 years ago); Hypertension (mild hypertension and it is well controlled, it was diagnosed 5-6 years ago)",,,"['Acoustic stimulation tests', 'Deafness unilateral', 'Ear discomfort', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 test', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1072538,,82.0,M,"pulmonary embolism; Covid 19 PCR positive (Igg also positive) with chest x-ray consistent with Covid pneumonia, 2 weeks after 1st dose; Covid 19 PCR positive (Igg also positive) with chest x-ray consistent with Covid pneumonia, 2 weeks after 1st dose; This is a spontaneous report from a non-contactable other healthcare professional. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was admitted with pulmonary embolism and Covid 19 PCR positive (Igg also positive) with chest x-ray consistent with Covid pneumonia, 2 weeks after the 1st dose of Pfizer vaccine. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject product contributed to the events. The reported events may likely represent intercurrent medical conditions. Pulmonary embolism is known to be a potential complication of COVID 19 infection, including COVID 19 associated pneumonia. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including pulmonary angiogram, VQ scan and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/01/2021,,,UNK,,,,,,"['Blood immunoglobulin G', 'COVID-19', 'Chest X-ray', 'Drug ineffective', 'Pulmonary embolism', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1072539,IL,66.0,F,"Ischemic stroke; not hypertensive, but supposedly is now.; Visual disturbances; Headache; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EM9810, expiry: unknown), via an unspecified route of administration in the left deltoid on 01Feb2021 14:15 at a single dose for covid-19 immunization at a Physician office. Medical history included asthma, irritable bowel syndrome, pneumonia and borderline high cholesterol. The patient's concomitant medications were not reported. The patient had no prior vaccinations within 4 weeks. The patient had her first COVID-19 vaccine on 01Feb2021 and second one is due on 22Feb2021. On 03Feb2021, the patient had a headache, but didn't think too much because it is a side effect. The headache lasted all through the weekend. Visual disturbances began 04Feb2021. She called her doctor on Monday and was seen by her doctor on Tuesday, 09Feb2021. The patient was referred to the eye center. Her headache was getting a little better. On 10Feb2021, the patient was seen at an institution, her retina and macula looked good, so she was referred to the ED. The patient was told she probably had a stroke. The patient was admitted to the hospital for an ischemic stroke. By looking at the MRI, the onset of the ischemic stroke would have been five to seven days prior, placing the onset on Wednesday, 03Feb2021, which was also the onset of her headache. There is no definitive cause of her ischemic stroke. The patient currently has an arrhythmia monitor on. MRI/MRA showed her vessels looked good. MRI showed evidence of the ischemic stroke. The patient has neurologists since being admitted to the hospital. It was thought that the headache was just because of the COVID-19 Vaccine. Causality was unknown, it was stated that they haven't found anything else as a cause. The patient's doctor stated she was borderline for high cholesterol. She was not hypertensive, but supposedly is now. The patient also had echocardiogram, EKG, manual neuro checks, and blood work but does not have the results. The outcome of the events was unknown. The has trouble reading now since the stroke.; Sender's Comments: Based on available information, the reported events are assessed as unrelated to the vaccine BNT162B2 and can be explained as intercurrent or underlying medical conditions in this elderly patient with excessive weight (BMI=29) and underlying elevated cholesterol. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/01/2021,02/03/2021,2.0,PVT,,,Medical History/Concurrent Conditions: Asthma (Verbatim: Asthma); Blood cholesterol increased; Irritable bowel syndrome (Verbatim: Irritable bowel syndrome); Pneumonia,,,"['Angiogram', 'Echocardiogram', 'Electrocardiogram', 'Headache', 'Hypertension', 'Investigation', 'Ischaemic stroke', 'Magnetic resonance imaging', 'Neurological examination', 'Visual impairment']",1,PFIZER\BIONTECH, 1072540,MA,78.0,F,"100% deaf, she couldn't hear a thing/ by 11 or 12 that same day, her hearing started to come back; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 78-year-old female patient received first dose of bnt162b2 (BNT162B2, Pfizer-Biontech Covid-19 Vaccine, Lot#: EL9266) via an unspecified route of administration on 14Feb2021 via injection into left arm at single dose for covid-19 immunization (COVID Protection for herself and so that she won't give COVID to anyone else). Medical history was none. There were no concomitant medications. The patient experienced 100% deaf, she couldn't hear a thing (medically significant) on 15Feb2021 with outcome of recovered. The patient underwent lab tests and procedures which included blood pressure measurement: good the consumer did not have a stroke , body height: 5'3- 5'4 states that she has been shrinking , body temperature: good the caller did not have a stroke, blood test: blood work done in the fall but it was all fine. The consumer says, ""I no problems with it. I came home, went to bed, I guess sometime during the night it happened. I got up at 6am- 100% deaf!"" The consumer says she was unable to couldn't hear gas stove turn on, couldn't hear the fridge shut, couldn't hear the microwave go off, couldn't head the phone ring. The consumer went to walk in-clinic. Hearing started coming back while being seen by the PA. The consumer was given ""5 prednisone pills to take if hearing doesn't come back, and was told to have them on hand in case you get the 2nd shot and it comes back"". The consumer says, ""I can hear perfect now"". ""It was a matters of hours"". The consumer ""searched it"" and read that this is very rare side effect, but temporary. The consumer asking if she should I get the 2nd shot in 2 weeks, because she heard the side effects with 2nd shot, could be worse. Caller asks, ""If I get the 2nd dose, will the hearing loss be temporary again or will it be permanent?"" The consumer states that last Sunday, she had her first dose of the COVID vaccine. The consumer states that she had no aches, no pains, no anything. The consumer states that sometime in the night, she got up, and was 100% deaf, she couldn't hear a thing, not one thing. The consumer states that in the morning she was standing in the kitchen and saw her phone blinking and she couldn't hear it ring. The consumer tested her hearing by putting half a cup of water in the microwave for 30 seconds, and she didn't hear the beep when it was done, she heard nothing, it was zero hearing at all. The consumer couldn't call anyone cause she knew she would not be able to hear them, and it was 6AM. The consumer states that she waited until she knew her daughter would be up, and the consumer texted her daughter and explained what happened, and the consumer's daughter tried to call, the caller's primary care doctor, but they put the consumer's daughter on hold and then hung up on her. The consumer states that her daughter texted someone at Pfizer, and they did not answer, so by that time it was 1030 or 11AM, and the caller drove herself to the walk in clinic. The consumer states that slowly but surely, her hearing came back. The consumer has some questions including, should she get the second dose of the product? Caller also states that she heard on TV that the second dose has stronger side effects than the first, and so she is wondering if that is true, and if she can expect this side effect to come back again with the second dose? Height: The consumer is 5'3- 5'4, and states that she has been shrinking. The consumer states that she read some of the side effects include, nausea and fatigue, she did not have any of those, and her arm was not even sore. But, caller states that this even scared her. The consumer states that by 11 or 12 that same day, her hearing started to come back. The consumer had driven to the walk in clinic, and at first could not hear what the staff said, but it started to come back while she was there, and she did not see a doctor, she saw a PA who gave the caller a prescription for 5 pills of Prednisone, and told the caller to not take them unless the deafness comes back, or gets worse. The consumer has not taken them because her hearing did come back. The consumer wants to say that she has recovered completely, but she does not know if it will come back with the second dose of the product, so she is unsure. The consumer states that she has not seen her grandkids in a year and a half, because they were afraid to come visit her because they did not want to give her COVID. The consumer confirms that she received no other vaccines on the same day. The consumer states that she did have a flu shot in the fall, but that is all. The consumer also had blood work done in the fall but it was all fine. The consumer states that when she went to the walk in clinic, the staff took her blood pressure and temperature and asked her to squeeze the PA's hands and stuff, and the PA said, good the consumer did not have a stroke.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/14/2021,02/15/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Blood pressure measurement', 'Blood test', 'Body height', 'Body temperature', 'Deafness transitory']",1,PFIZER\BIONTECH, 1072541,NY,49.0,M,"classic symptoms in my right eye - pain, significant/redness/inflammation; some loss of visual acuity; uveitis/prior episodes of iritis/uveitis, but was symptom free; iritis/uveitis/prior episodes of iritis/uveitis, but was symptom free; iritis/prior episodes of iritis/uveitis, but was symptom free; iritis/prior episodes of iritis/uveitis, but was symptom free; classic symptoms in my right eye - pain, significant/redness/inflammation; classic symptoms in my right eye - pain, significant/redness/inflammation; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm on 16Feb2021 15:00 at a single dose for COVID-19 immunisation. The patient's medical history included HLA-B27 gene mutation and iritis/uveitis. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. There were no concomitant medications. On 18Feb2021 23:00, the patient experienced iritis/uveitis. He had prior episodes of iritis/uveitis, but was symptom free and not taking any medications for it as of his innoculation date. He have now developed the classic symptoms in his right eye - pain, significant/redness/inflammation and some loss of visual acuity. Therapeutic measures were taken as a result of prednisone eye drops and ibuprofen (ADVIL) for pain. Outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/18/2021,2.0,UNK,,,Medical History/Concurrent Conditions: Chromosome analysis abnormal (HLA-B27 mutation); Iritis; Uveitis,,,"['Disease recurrence', 'Eye inflammation', 'Eye pain', 'Iritis', 'Ocular hyperaemia', 'Uveitis', 'Visual acuity reduced']",1,PFIZER\BIONTECH, 1072542,NC,68.0,M,"swelling migrated from right lower jaw region over lips and stopped at the left side of lips; slurred voice; rash with whelps across his back and down both legs with itching irritation; rash with whelps across his back and down both legs with itching irritation; swelling migrated from right lower jaw region over lips and stopped at the left side of lips; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration on 06Feb2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included diabetes mellitus, hypertension, and gastrooesophageal reflux disease (GERD). Concomitant medications included metformin, gabapentin, atorvastatin, and alprenolol hydrochloride (ATENENOL). The patient previously took Demerol and aspirin experienced allergies (known allergies). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 18Feb2021 06:30, the patient experienced swelling migrated from right lower jaw region over lips and stopped at the left side of lips, some swelling has continued, and slurred voice (more pronounced when standing). On the same day at 06:30, the patient experienced rash with whelps across his back and down both legs with itching irritation. The events resulted in doctor or other healthcare professional office/clinic visit. The events were treated with Zyrtec and Kenalog. The patient has not been tested for COVID-19 since the vaccination. The patient has not recovered from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/18/2021,12.0,UNK,METFORMIN; GABAPENTIN; ATORVASTATIN; ATENENOL,,Medical History/Concurrent Conditions: Diabetes; GERD; Hypertension,,,"['Dysarthria', 'Lip swelling', 'Rash pruritic', 'Swelling face', 'Urticaria']",1,PFIZER\BIONTECH, 1072543,CA,86.0,F,"Like I'm having a stroke; neck ache; nightmares; nervousness; Felt terrible with bad headache; This is a spontaneous report from a contactable consumer (patient). An 86-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6200) via an unspecified route of administration on 15Feb2021 13:00 at single dose in left arm for COVID-19 immunisation. She received the first dose of BNT162B2 (lot number: EL9262) on 18Jan2021 13:00 in left arm for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was allergic to Formaldehyde, Coumadin. Concomitant medication included levothyroxine sodium (LEVOXYL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Feb2021, the patient felt terrible with bad headache. On 18Feb2021 also felt terrible. On 17Feb2021 08:00, Like she was having a stroke. Headache, neck ache, nightmares, nervousness. Blood pressure was ok. Oxygen was ok. Pulse was ok. No treatment received for the adverse events. Events outcome was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/15/2021,0.0,PUB,LEVOXYL,,,,,"['Blood pressure measurement', 'Cerebrovascular accident', 'Headache', 'Heart rate', 'Neck pain', 'Nervousness', 'Nightmare', 'Oxygen saturation']",2,PFIZER\BIONTECH, 1072544,,,U,"ITP (Immune Thrombocytopenia); This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 13Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had since returned to the clinic with ITP (Immune Thrombocytopenia) with a platelet count of 10/abnormal, which they were treating with steroids. The doctor had already prescribed; Prednisone 20mg, 3 tablets daily, 100 count. The reporter asked it ITP was a reported AE and if there was a protocol for treatment besides the steroids. The provider already directed caller not to get the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. The company cannot completely exclude a causal relationship between the event immune thrombocytopenia and suspect vaccine BNT162B2. Additional information regarding relevant medical history, underlying conditions, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,,,UNK,,,,,,"['Immune thrombocytopenia', 'Platelet count']",1,PFIZER\BIONTECH, 1072546,CA,38.0,M,"seizure 3 days after vaccine; This is a spontaneous report from a contactable other health professional. A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included seizure. The patient had known allergies: Risperidone. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced seizure 3 days after vaccine on 25Jan2021. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported seizure cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/25/2021,,UNK,,,Medical History/Concurrent Conditions: Seizures,,,['Seizure'],UNK,PFIZER\BIONTECH, 1072547,NV,75.0,F,"maybe she is getting Ebola; blotching; arms were itching/ it was her right arm that she got the shot; had blotches on her arm, it was only the arm she got the shot in; rash/like there were ants all over her back, head, legs, under her breast and under her arms in between legs; Itching/ like there were ants all over her back, head, legs, under her breast and under her arms in between legs; This is a spontaneous report from a contactable consumer (patient). This 75-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiration date: May2021) via an unspecified route of administration in the right arm on 01Feb2021 at single dose for covid-19 immunisation. Medical history included hear disorder, sulfa allergy, allergic to iodine, being shrinking she was 5'4"" the last time she looked at it but she has shrunk, she was not sure but she thought she was currently shorter than 5'4"". The patient would like to know if it has sulfa and iodine in BNT162B2. Concomitant medications included insulin, blood pressure medication and heart medication. The patient received first dose of vaccine and experienced a rash and itching on 02Feb2021. The patient was broke out, she had a rash since she had the shot, it was like there were ants all over her back, head, legs, under her breast and under her arms in between legs. The doctor gave her Hydroxyzine for the itch and she just wanted to know, she was leery of going to get the second dose, she wanted to know was the second dose going to make it worse. The patient was scheduled to go for the second one 22Feb2021. She said the first day she got it she was fine, there was nothing, she was waiting for something to happen then she started with the rash. She was taking her blood pressure medication and insulin but she noticed that on the inside of her, on the top of the head was itching, it was the next day, and then toward the evening under her arms were itching and then between her legs and ankles and it was her right arm that she got the shot in and it started blotching. She showed it to the nurse at the office and she told the nurse maybe she was getting Ebola. She had blotches on her arm, it was only the arm she got the shot in. She still had the blotches she still had quite a few. She can still see them but they were getting lighter. Under her breast was still bugging her. She confirmed the itching and rash began the next day, after the first vaccine dose. It had improved since her doctor gave the pills to stop the itching. She was able to sleep, before she couldn't sleep she had to get up and take showers but since he had given the medicine it was improved and she had used salve, it was Cortisone but her under the bra it still itched where it was pressuring. She was going to have a labs taken to see if there was anything different. She took insulin and heart medication since forever and she even stopped to see, she said it was probably a bad thing but she stopped taking her heart medication to see if it was interacting, she stopped taking her insulin and her heart rate went up, everything was still the same, now she went back and started taking the insulin and heart medication again. Outcome of the event maybe she is getting Ebola was unknown, of the other events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/02/2021,1.0,UNK,INSULIN,Body height decreased,Medical History/Concurrent Conditions: Heart disorder; Iodine allergy; Sulfonamide allergy,,,"['Body height', 'Ebola disease', 'Pruritus', 'Rash', 'Rash macular', 'Vaccination site pruritus', 'Vaccination site rash']",1,PFIZER\BIONTECH, 1072548,,,M,"erectile dysfunction; flu-like symptoms; bodyaches and muscle ache after waking up; bodyaches and muscle ache after waking up; phantom pains on the feet; mild swelling in the hands; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (Age: 64; Unit: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 01Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on 01Feb2021 and experienced some flu-like symptoms on an unspecified date in Feb2021. As he was getting closer to the second dose, he started feeling some bodyaches and muscle ache after waking up (would go away after doing a bit of exercise), phantom pains on the feet, mild swelling in the hands, and erectile dysfunction, all on an unspecified date in Feb2021. The patient was looking for information if these symptoms were related with the vaccine and if he was safe to get the second dose. The patient mentioned talking to his physician about his experience and he was given ibuprofen for the pain. However, he also heard on the news that it should not be taken with the vaccine. The patient asked if there was more information on this, if it was true and if there was a recommended timeframe. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,,,,,"['Erectile dysfunction', 'Influenza like illness', 'Myalgia', 'Pain', 'Peripheral swelling', 'Phantom limb syndrome']",1,PFIZER\BIONTECH, 1072549,IL,83.0,F,"Pounding in head; Heart pounding; Elevated BP; bouncing off the walls, and going from side-to-side when she tried to walk; oxygen saturation level kept dropping; shaking; cold; Weakness; Tiredness; Throat tightness; Dry mouth; This is a spontaneous report initial from a contactable nurse and follow up from a Pfizer-sponsored program. This Nurse (patient) reported for self that the 83-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on 17Feb2021 09:30AM on right arm at single dose for covid-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing Reported she was diagnosed with Rheumatoid Arthritis about 10 years ago, fibromyalgia from an unknown date and unknown if ongoing and stated when the doctor couldn't figure out what was causing her pain, the doctor said she had Fibromyalgia, carotid endarterectomy from 2014, pain in extremity from an unknown date and unknown if ongoing She said she has rheumatoid arthritis, and has had terrible leg pain for a long time. Family Medical History Relevant to AE(s) was not provided. Concomitant medication included cortisone (CORTISONE) for Pain in leg from 10Feb2021 and stated her doctor gave her a Cortisone shot in her right knee to help with her right leg pain. Reported she received a Cortisone shot in her right knee on Wednesday, 10Feb2021. She said the doctor gave her the Cortisone shot in her right knee to see if it would help her right leg pain. She said she has a problem with Cortisone, clarifying the Cortisone keeps her awake. She said the doctor wanted her to have another Cortisone shot in 3 months, and she is not going to take the Cortisone shot because she doesn't like how the Cortisone makes her feel. The patient experienced pounding in head (hospitalization, medically significant), heart pounding (hospitalization, medically significant), elevated bp (hospitalization, medically significant), bouncing off the walls, and going from side-to-side when she tried to walk (hospitalization, medically significant), dry mouth (medically significant) all on 17Feb2021 with outcome of recovering, throat tightness (medically significant) on 18Feb2021 with outcome of recovering, weakness (medically significant) on 19Feb2021 with outcome of not recovered, tiredness (medically significant) on 19Feb2021 with outcome of not recovered, oxygen saturation level kept dropping on an unspecified date with outcome of unknown, shaking on an unspecified date with outcome of unknown , cold on an unspecified date with outcome of unknown. He experienced terrible pain in the leg after the 1st dose and took a marijuana cookie and she was rushed to the ER because she was shaking and cold. The patient was hospitalized for events pounding in head, heart pounding, elevated bp and bouncing off the walls, and going from side-to-side when she tried to walk from 17Feb2021 to 18Feb2021. The nurse states that ""I told her up until a Month ago, she was taking care of a huge house and husband that is blind. I've been having the pain in my legs for over a month, doppler was done, and I had an injection in my knee with cortisone, I won't do that again, it keeps me awake at night. There is no diagnosis yet on the pain, have an orthopedic appointment coming up. Caller states, I got the first Pfizer vaccine shot on Wednesday at 9:30 am in right arm. Never so much have felt it. or have not felt anything else since. My friend talked me into eating a marijuana cookie about 5pm that day, and at 6 or 6:30pm, I started feeling terrible, my head was feeling terrible, my heart was pounding, I could hardly walk, my mouth was dry as a bone. we called paramedics, we found out on Friday before the shot that I have a right bundle block. Woke up 4:30 in the morning the Friday before with chest pain. EKG found right bundle block, my blood pressure was 245/105, that night in the ER, they got my blood pressure down and sent me home. Wednesday, I had the covid shot in right arm, at 9:30am, that day about 4:30 - 5:00 had the cookie thing, about 6pm, had to call the paramedics, they kept me in the hospital overnight. because my oxygen saturation kept dropping, down in the 86% or 89%, I don't know. Gave me breathing treatments, CT scan for blood clots in lungs was done, Doppler for blood clots in legs, and a HgbA1C. They did an echo of my chest. I don't know all of the results yet. Even yesterday, in the hospital I felt better, but feel week and tired, while walking the hall in the hospital my Blood pressure went up a little bit. I told the nurse, my head feels like this when my blood pressure is up. They sent me home last night. Today, I am feeling okay. My mouth is still a little dry, got a little better yesterday. My legs are still killing me, I have an appointment with my Cardiologist and Rheumatologist, I have Rheumatoid Arthritis. My question is , the doctor didn't know if it was from the cookie or from the vaccine. I am wondering if I should get the second vaccine."" She stated she never had a sore arm after getting the COVID-19 Vaccine. She said she did something stupid after she received the COVID-19 Vaccine. She said she has rheumatoid arthritis, and has had terrible leg pain for a long time. She said her friend talked her into having a cookie that had marijuana in it. She said her leg pain was so severe at the time, she took the cookie with marijuana in it around 4:30PM-5:30PM on 17Feb2021. She said at 7:00PM she was bouncing off the wall (clarified as unsteady, and going from side-to-side when she tried to walk), her head was pounding, her heart was pounding, she was dizzy and shaky. She said she went to the hospital emergency room. She said the hospital kept her overnight because her oxygen saturation level kept dropping. She said she got home from the hospital last night (18Feb2021), clarifying she was discharged from the hospital at 6:00PM. She said she noticed her mouth was very dry when she went to the hospital on 17Feb2021, and her mouth continued to stay very dry all night. Caller asked if she should get the second COVID-19 Vaccine shot after experiencing what she did after receiving the first COVID-19 Vaccine. Reported her leg pain became severe about a month ago, clarifying she has had leg pain for a long time. Reported her blood pressure was up while she was at the hospital, clarifying she had one blood pressure reading of 145/82 that she recalls. She said her blood pressure is pretty normal, and she takes blood pressure medications. She said she believes her heart rate was up too, but was unsure what her heart rate was. Reported a couple days before receiving her first Pfizer COVID-19 Vaccine, she went to her doctor on 12Feb2021 because she was having severe chest pain. She said her doctor did an EKG and told her she had a right bundle branch block. She said her doctor sent her to the hospital Emergency Room. She said while she was in the Emergency Room she had an extremely high blood pressure of 245/105. She said she came home from the Emergency Room on 12Feb2021, and had a couple spells, but was OK. She said she was OK when she went to get her first COVID-19 Vaccine shot on Wednesday, 17Feb2021. Reported she had difficulty reading her COVID-19 Vaccine Immunization Card. She said the Pfizer COVID-19 Vaccine Lot Number looked like EN6200, and there was no NDC Number, or Expiration Date listed on the card. Reported she had blood work done at the hospital. No further details provided. Treatment included she was given Albuterol breathing treatments while in the hospital, along with some other things that she can't remember. Reported she believes her symptoms were medically significant because she was nervous from recently being to the Emergency Room for her severe chest pain a few days before. Reported she did not think her symptoms were from the COVID-19 Vaccine. She said she thought the cookie with marijuana in it caused her symptoms because the symptoms happened about 1-1/2 to 2 hours after she had the cookie with marijuana in it. Reported she feels very weak and tired. Reported yesterday (18Feb2021) while she was in the hospital, her head felt like it was going to explode when the hospital staff tried walking her around. She said she asked the hospital staff to check her blood pressure because her head will feel like that when her blood pressure is up. She said when the hospital staff checked her blood pressure, her blood pressure was elevated. Reported the pain in her legs is driving her crazy, so she called for an appointment with an orthopedist today. Reported she is feeling better, but is still experiencing a tightness in her throat. She clarified she felt the throat tightness on Wednesday, 17Feb2021. She said she has no problem swallowing or eating, but her throat feels tight. Vaccination Facility Type was Hospital. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. AE(s) required a visit to: Emergency Room (admitted to hospital), no Physician Office. Prior Vaccinations (within 4 weeks) was none.; Sender's Comments: The 83-year-old female patient had medical history included rheumatoid arthritis, fibromyalgia and carotid endarterectomy, and was on multiple concomitant drugs. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of the reported events, cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/17/2021,02/17/2021,0.0,PVT,CORTISONE,,"Medical History/Concurrent Conditions: Carotid endarterectomy; Fibromyalgia (Stated when the doctor couldn't figure out what was causing her pain, the doctor said she had Fibromyalgia.); Leg pain (She said she has rheumatoid arthritis, and has had terrible leg pain for a long time.); Rheumatoid arthritis (Reported she was diagnosed with Rheumatoid Arthritis about 10 years ago.)",,,"['Asthenia', 'Balance disorder', 'Blood pressure increased', 'Blood pressure measurement', 'Blood test', 'Dry mouth', 'Echocardiogram', 'Electrocardiogram', 'Fatigue', 'Headache', 'Heart rate', 'Nasopharyngitis', 'Oxygen saturation', 'Oxygen saturation decreased', 'Palpitations', 'Throat tightness', 'Tremor']",1,PFIZER\BIONTECH, 1072550,CO,68.0,F,"Bell Palsy; This is a spontaneous report from a contactable consumer (patient) reported that a 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration on the left arm on 17Feb2021 11:30 at a single dose for covid-19 immunization. The vaccine was administered at the hospital. Medical history included blood pressure, cholesterol, and gastrooesophageal reflux disease (GERD); all from an unknown date. Patient was not pregnant at the time of vaccination. Concomitant medications included benazepril, oxybutynin hydrochloride (OXYBUTININ ACCORD), ezetimibe, fenofibric acid, and esomeprazole; all were taken from an unspecified date for an unspecified indication. The patient experienced facial numbness then the patient went to the ER and was diagnosed with Bell's palsy on 17Feb2021 16:00. The patient underwent lab tests and procedures which included computerised tomogram: unknown result on an unspecified date. Therapeutic measures were taken as a result of bell palsy. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,PVT,BENAZEPRIL; OXYBUTININ ACCORD; EZETIMIBE; FENOFIBRIC ACID; ESOMEPRAZOLE,,Medical History/Concurrent Conditions: Blood pressure; Cholesterol; GERD,,,"[""Bell's palsy"", 'Computerised tomogram']",1,PFIZER\BIONTECH, 1072551,FL,79.0,F,"short of breath; nose bleed/lost a lot of blood/bleeding; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL9263 and expiry date unknown, via unspecified route of administration on 26Jan2021 at single dose for Covid-19 immunization, and eicosapentaenoic acid ethyl ester (VASCEPA), acetylsalicylic acid (BABY ASPIRIN); both via unspecified route of administration from unspecified date to 31Jan2021 at unknown dose and frequency for unspecified indication. Medical history was none. Concomitant medication was not reported. The patient had taken the first shot of the Pfizer shot on 26Jan2021 (Tuesday) and the patient seemed to managing it pretty well, she got short of breath one night (unspecified date) but in general, she felt okay. But several days later, 5 days later Sunday (31Jan2021), on Sunday morning she felt okay, what happened was she leaned a little bit, she bent down to wash her hands in the sink and she had a huge nose bleed, it was nothing like she ever had before, she was just wiping, spurting a lot of blood so this was 5 days. It was the morning of the 5th day and they had to call an ambulance to take her to the hospital and then she left the hospital. The patient had lost a lot of blood in the ambulance, they said they had never seen so much blood, they could not stop it, they kept giving her towels and the same thing in the hospital, in the emergency room. The patient was just bleeding over everywhere. The patient informed that for the last several years she has been having one baby aspirin and has been taking for the last few months or two, two or four Vascepa which was a fish oil supplement that can thin the blood but she has never had anything like this and they said go to her ENT, and she went up going ENT, and first time she went she would not take out the packing. The patient informed that it was too severe for her to take out the packing and, when she went back with her following time she took some of the packing and it started to bleed again and she cauterized it in a lot of places and you know would wait and do it again. And then she end up putting some kind of bandage that was going to help the blood clotting. Now, she has been subsequently going back to her and it was still in the very end of. The patient informed that she was still passing some very small blood clots, it has not even stopped. The patient informed that she was on 19 days passed already, since she had the bleed. The patient was very concerned. The patient informed that she was supposed to get her second vaccine in 2 to 3 days, Tuesday and she thought that this was the very bad experience that she had. The patient wanted to know if the aspirin and fish oil could have contributed to this, she stopped these as of 31Jan2021. The patient was talking to her daughter and her daughter has a friend whose mother lives in the same area and had her first Pfizer vaccine and had a small nose bleed right afterwards and then when she has second vaccine, she had another, a very bad. The patient informed that her daughter and a friend of hers said that a similar reaction occurred to her mother after the first dose of the Pfizer vaccine, she had two small nasal bleeds and right afterwards, when she took the second vaccine she had a very big one, like hers, where she had to be taken to the hospital. The patient was concerned, she has been told that the response to the 2nd vaccine was stronger than the first. The patient further informed that she had no nose bleed like this before, like her husband was a physician, that she never had anything like this before, this was very serious kind of situation to happen, and this after the very first vaccine that she had. She had a very severe nosebleed, she had to go to the hospital to stop it. She was on a baby aspirin and some fish oil as well. The patient informed that she wasn't warned that this could thin her blood, that this was enough of a dose to do anything to create this deluge of bleeding. The patient informed that she was few days out from getting her second shot and she had stopped the baby aspirin and the fish oil about three weeks ago. The patient informed that she was not going to take second. The patient wanted to know how long she was going to wait, how long she was going to test her antibody and see that she don't have any more antibodies and will go take the other brand vaccine. The patient added she was reporting that she had a terrible nosebleed and wanted to file a safety report. The patient wanted to know that if she choose not to get the 2nd vaccine, because of her worry of having this reaction again, how long would it be before she could get another vaccine; how long can she wait to get the second dose, or can she get a second dose from another manufacturer. The patient was requested to contact physician. The action taken in response to the events for eicosapentaenoic acid ethyl ester (VASCEPA) and acetylsalicylic acid was permanently withdrawn. The outcome of the events was unknown.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the BNT162B2 and the event nosebleed cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021191054 same reporter, similar drug/events, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/31/2021,5.0,UNK,VASCEPA; BABY ASPIRIN,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dyspnoea', 'Epistaxis']",1,PFIZER\BIONTECH, 1072552,CA,77.0,F,"Have had benign PVCs in the past usually maybe 3 episodes a month. Four days after 2nd vaccine injection, I started to experience daily episodes 4 or 5 times per day in most cases; Have had benign PVCs in the past usually maybe 3 episodes a month. Four days after 2nd vaccine injection, I started to experience daily episodes 4 or 5 times per day in most cases; This is a spontaneous report from a contactable consumer who reported for herself, a 77-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 9262), via an unspecified route of administration in the left arm, on 09Feb2021 at 07:30, at the age of 77 years, at a single dose for COVID-19 immunization. Medical history included diabetes, spinal stenosis, and ongoing PVCs. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Concomitant medications included metformin, statin, and hydrochlorothiazide. The patient previously took codeine and had allergy; and received the first dose of BNT162B2 (Pfizer, Lot number: EL1284) on 19Jan2021 at 03:00 PM, at the age of 76 years, in the right arm, for COVID-19 immunization. It was reported that patient have had benign PVCs in the past - usually maybe 3 episodes a month. On 13Feb2021, reported as ""four days after 2nd vaccine injection"", patient started to experience daily episodes - 4 or 5 times per day in most cases. From day 4 to day 11, experiencing these episodes. On day 11 they started to subside. Patient was taking essential electrolytes and extra magnesium to help. The events were reported as non-serious. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/13/2021,4.0,UNK,METFORMIN; HYDROCHLOROTHIAZIDE,Premature ventricular contractions (Have had benign PVCs in the past - usually maybe 3 episodes a month.),Medical History/Concurrent Conditions: Diabetes; Spinal stenosis,,,"['Condition aggravated', 'Ventricular extrasystoles']",2,PFIZER\BIONTECH, 1072553,IL,54.0,M,"Diagnosed with Bell's Palsy on 19Feb2021; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration at the right arm on 06Jan2021 at a single dose for COVID-19 immunization. The vaccine was administered to the patient at a hospital. The patient had no COVID prior to vaccination. The patient's medical history was not reported. Concomitant medication included lisinopril and metoprolol. The patient had no other vaccine in four weeks. The patient was diagnosed with Bell's Palsy on 19Feb2021 (start of event was reported as 19Feb2021 at 06:15 AM). The event resulted in doctor or other healthcare professional office/clinic visit. The patient had COVID test post vaccination which was a nasal swab with unknown results on an unspecified date in 2021. Therapeutic measures were taken as a result of event Bell's Palsy which included unspecified medication. The outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: The possibility that suspect drug may have contributed to the reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,02/19/2021,44.0,PVT,LISINOPRIL; METOPROLOL,,,,,"[""Bell's palsy"", 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1072554,OR,66.0,M,"Gradually progressive peripheral neuropathy in toes then fingers.; This is a spontaneous report from a contactable physician (patient). A 66-year-old male patient received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EK9231) solution for injection, via an unspecified route of administration in left arm on 10Jan2021 14:30 at a single dose for Covid-19 immunization. Medical history included Paroxysmal Atrial Fibrillation, (HTN) hypertension, obesity, intermittent asthma, and benign prostatic hyperplasia (BPH). Patient had no known allergies. Concomitant medication included apixaban (ELIQUIS), atorvastatin (ATORVASTATIN), losartan (LOSARTAN), dutasteride, and tamsulosin hydrochloride (JALYN). The patient experienced gradually progressive peripheral neuropathy in toes then fingers on 18Jan2021. No treatment received. The event resulted in doctor or other healthcare professional office/clinic visit. The second dose was administered on 31Jan2021 at 9am (lot number: EL9262) in right arm. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not been tested for Covid-19 after vaccination. Outcome of the event was not recovered. No follow-up activities are needed. No further information is expected.; Sender's Comments: Considering the plausible temporal association, the reasonable possibility that the reported progressive peripheral neuropathy in toes then fingers (Neuropathy peripheral), occurred 8 days after the first dose, is related to BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/10/2021,01/18/2021,8.0,PVT,ELIQUIS; ATORVASTATIN; LOSARTAN; JALYN,,Medical History/Concurrent Conditions: Asthma; BPH; Hypertension; Obesity; Paroxysmal atrial fibrillation,,,['Neuropathy peripheral'],1,PFIZER\BIONTECH, 1072555,FL,73.0,M,"The second evening after the shot I developed AFIB; chills; 101 fever; sweats; fatigue; This is a spontaneous report from a Contactable Consumer. A 73-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6200), the second dose, via an unspecified route of administration on 20Feb2021 on Left arm at single dose for covid-19 immunisation . Medical history included 2 stents, ablation surgery from Jun2018, gall bladder and appendix removed, penicillin allergy. Concomitant medication included ticagrelor (BRILINTA), metoprolol (METOPROLOL), olmesartan , pravastatin . The patient previously took cipro [ciprofloxacin] and experienced allergy. He received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:En5318) on 30Jan2021 10:45 AM on left arm for covid-19 immunization. Approximately 10 hours after second pfizer vaccination (20Feb2021) he developed chills, then a 101 fever, sweats and overall fatigue. Symptoms lasted about a day and a half. The second evening (21Feb2021) after the shot he developed AFIB. He had surgery in Jun2018 to correct AFIB and have not had an occurrence since prior to this. The patient underwent lab tests and procedures which included body temperature: 101 on 20Feb2021. Outcome of events was not recovered. No treatment received for all events. Follow-up attempts are completed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,UNK,BRILINTA; METOPROLOL; OLMESARTAN; PRAVASTATIN,,Medical History/Concurrent Conditions: Appendectomy (gall bladder and appendix removed); Gallbladder removal (gall bladder and appendix removed); Penicillin allergy; Stent placement; Surgery,,,"['Atrial fibrillation', 'Body temperature', 'Chills', 'Fatigue', 'Hyperhidrosis', 'Pyrexia']",2,PFIZER\BIONTECH, 1072556,IN,70.0,F,"right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen and throbbed; Right leg ankle still hurt; flu symptoms appeared; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; tired; chills; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 11Feb2021 10:00 at single dose in arm left for COVID-19 immunisation. There was no medical history and no known allergies. Concomitant medication included colecalciferol (D3) and multi vitamin. The patient did not have COVID prior vaccination. There was no other vaccine in four weeks. After about 4 hours after first Pfizer shot on a Thurs (11Feb2021), the patient experienced flu symptoms appeared, Left arm, muscles, joints hurt, chills, tired, not feeling well, on 11Feb2021 16:00. Right leg ankle still hurt after 24 hours Friday and Saturday by Sunday. Right leg calf was red swollen and throbbed on 14Feb2021 16:00. Monday (on 15Feb2021) the patient called physician and had sonogram on right leg which showed blood clot in lower back of leg from ankle to knee. Doctor put immediately on rivaroxaban (XARELTO) blood thinner for blood clot. Blood work has been done on 15Feb2021. The patient would follow up on 02Mar2021. She was concerned about taking second COVID vaccine dose on 04Mar2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid was not tested post vaccination. The event outcome was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/11/2021,0.0,PVT,D3,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Arthralgia', 'Blood test', 'Chills', 'Fatigue', 'Influenza', 'Malaise', 'Myalgia', 'Pain in extremity', 'Peripheral swelling', 'Thrombosis', 'Ultrasound scan', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1072557,IN,,M,"heart attack; severe chest pains; This is a spontaneous report from a contactable consumer (patient). This 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EN5318) on 08Feb2021 at 02:45 PM at single dose at right arm for Covid-19 immunization. Medical history included COVID prior vaccination. No known allergies. Concomitant medications included every day meds. It was reported that next night, on 09Feb2021 10:45 PM, patient had severe chest pains thought having heart attack went to hospital. Could not go back. The events were resulted in Emergency room/department or urgent care. Treatment was received for events and patient underwent lab tests included CT scan, blood test and etc on unspecified date with unknown results. Patient did not test COVID post vaccination. The outcome of events was recovered on unspecified date.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/08/2021,02/09/2021,1.0,PVT,,,Medical History/Concurrent Conditions: COVID-19,,,"['Blood test', 'Chest pain', 'Computerised tomogram', 'Myocardial infarction']",1,PFIZER\BIONTECH, 1072709,CA,72.0,M,"3 days after receiving his first dose, patient had 102 fever and contracted COVID Pneumonia and is now hospitalized in the ICU",Not Reported,,Yes,Yes,5.0,Not Reported,N,02/18/2021,02/21/2021,3.0,OTH,Benicar; Atorvastatin Allipurinol; antihistamine,No,High blood pressure ; allergies,,Cats; dogs; household dust,"['COVID-19 pneumonia', 'Intensive care', 'Pyrexia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,SYR 1072717,LA,63.0,M,"Resident received 2nd dose of COVID vaccine 3/3/2021 at about 11:00am. At 18:08, primary care nurse at that time checked VS and noted resident's temp to be 100.2 with nausea and vomiting. by 18:15 resident temp was up to 102.1 and SaO2 83% and was placed on oxygen via nonrebreather mask. 911 was called and transported resident to hospital.",Not Reported,,Not Reported,Yes,,Not Reported,U,03/03/2021,03/03/2021,0.0,SEN,"Celexa 20mg PO daily - depression Combivent Respimat aerosol sol 2 puffs every 8 hours as needed for SOB Flomax 0.4mg PO daily for benign prostatic hyperplasia Melatonin 3mg tabs, take 2 tabs at bedtime for insomnia Miralax powder 17 gram m",malignant prostate,Gastric Reflux Disease Malignant Prostrate,,NKDA,"['Body temperature increased', 'Nausea', 'Vomiting']",2,MODERNA,IM 1072740,MD,85.0,M,"Patient presented to the ED with worsening dyspnea and lower extremity edema. Patient was found to have an elevated BNP with chest x-ray showing pulmonary edema. Patient has been treated with IV diuretics. Nephrology was also consulted due to worsening BUN/creatinine. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine",Not Reported,,Not Reported,Yes,,Not Reported,,02/05/2021,02/25/2021,20.0,PVT,,,,,,"['Blood creatinine abnormal', 'Blood urea abnormal', 'Brain natriuretic peptide increased', 'Chest X-ray abnormal', 'Dyspnoea', 'Oedema peripheral', 'Pulmonary oedema']",1,MODERNA,IM 1072757,MO,40.0,F,2/25/2021- Admitted to hospital following severe high-grade fevers and headaches. Received her second dose of Pfizer COVID vaccine on 2/24/2021. Reported fevers as high as 105 at home. Admitted for IV hydration. Her fever persisted 24 hours after admission and headaches got worse. Patient started on Topamax with better control of headaches. Fever subsided 24 hours prior to discharge. Discharge home on 2/28/2021.,Not Reported,,Not Reported,Yes,4.0,Not Reported,U,02/25/2021,02/25/2021,0.0,PVT,"Alprazolem, Citirizine, Ergocalciferol, Metoprolol XL, Ondensetron, Oxycodone, KCL., Prochlorpirazine, Sumatriptan, Topiramate",,"Stage IV malignant melonoma with mets to lung, headaches, symtomatic PVCs & PACs, HTN, anxiety",,,"['Blood culture', 'Blood test', 'Computerised tomogram head', 'Condition aggravated', 'Headache', 'Lumbar puncture', 'Pyrexia']",UNK,PFIZER\BIONTECH,IM 1072763,PR,79.0,M,"The same day that the person was vaccinated he started feeling dizzy and had difficulty breathing. He was hospitalized from February 5 to February 23. Patient died in the hospital on February 23, 2021",Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,UNK,Unknown,"The patient was convalescent from COVID-19, his first positive PCR COVID-19 test was on December 23, 2020. The patient was hospitalize on December 22, 2020 and was check out on December 25, 2020.",Diabetes and AIDS,,Unknown,"['COVID-19', 'Death', 'Dizziness', 'Dyspnoea', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1072810,NC,72.0,F,"SOB and HTN on 1/30/21, 3 wks after 1st Covid shot. Submassive acute saddle pulmonary embolism. Pt was sent by ambulance to ER. On arrival, CT revealed a saddle embolism. Heparin was initiated and pt was transported to hospital. Admitted to ICU and bil thrombolytic catheters were placed. On 1/31/21 thrombosis has dissolved. on cessation of thrombolysis and removal of lytic stents on 1/31/21 pt was placed on Xarelto. Pt was D/C on 2/1/21.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,Unsure,Unsure,Unsure,,Unsure,"['Catheter directed thrombolysis', 'Computerised tomogram thorax abnormal', 'Dyspnoea', 'Hypertension', 'Intensive care', 'Pulmonary embolism']",1,MODERNA,IM 1072815,MD,83.0,F,"Patient was briefly admitted to undergo a cardiac catheterization. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,,02/19/2021,02/26/2021,7.0,PVT,,,"HTN, HLD, hx of TIA",,,['Catheterisation cardiac'],2,MODERNA,IM 1072853,MD,66.0,M,"Patient was admitted for confusion and difficulty getting words out. Imaging studies showed a lesion in the left frontal lobe and neurosurgery was consulted. Neurosurgery believed lesion was possible an acute/subacute infarct however morphology was unusual. Patient's symptoms resolved and he was discharged, instructed to follow up with neurology and PCP. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.",Not Reported,,Not Reported,Yes,5.0,Not Reported,,02/05/2021,02/25/2021,20.0,PVT,,,,,,"['Aphasia', 'Central nervous system lesion', 'Confusional state', 'Dysarthria', 'Imaging procedure']",1,MODERNA,IM 1072881,MD,92.0,M,"Patient was referred to the ED by his cardiologist for bradycardia. Patient underwent a procedure to have pacemaker placed. He remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,,02/11/2021,02/25/2021,14.0,PVT,,,,,,"['Bradycardia', 'Cardiac pacemaker insertion']",1,PFIZER\BIONTECH,IM 1072895,MA,55.0,F,"I received my second Moderna COVID vaccine on 1/31 ( lot: 028L20A, exp 7/29/21) . The next day 2/1 I had a severe reaction with temps to 103, chills, rigors, nausea and vomiting. I was in the bathroom vomiting and passed out, and fell and hit my head on the tub. On 2/8 for two weeks and had residual fatigue but no other symptoms. 2/24 around 7 pm I had sudden onset of paraesthesias ( pins and needles) in both feet, over 30 min it progressed up to my knees and my legs and feet were numb. The next morning I went to the ER and was admitted.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/31/2021,02/01/2021,1.0,WRK,,,,,,"['Blood test', 'Chills', 'Computerised tomogram head', 'Fall', 'Fatigue', 'Head injury', 'Loss of consciousness', 'Lumbar puncture abnormal', 'Magnetic resonance imaging abnormal', 'Magnetic resonance imaging head', 'Magnetic resonance imaging spinal', 'Nausea', 'Paraesthesia', 'Pyrexia', 'Vomiting']",2,MODERNA,IM 1072902,MD,83.0,F,"Patient was admitted for generalized weakness, observed overnight. Cardiology saw the patient believe that patient's weakness could be attributed to borderline hypotension. They will arrange outpatient Holter monitoring. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/12/2021,02/25/2021,13.0,PVT,,,,,,"['Asthenia', 'Hypotension']",UNK,PFIZER\BIONTECH,IM 1072952,PA,65.0,F,"Patient received her 2nd Moderna COVID vaccine dose on 2/26 at 2:00PM. She started with urticaria at approximately 4:30PM. She took a dose of cetirizine that helped to alleviate the urticaria. She then started to develop tongue swelling around 10:00 PM, but noticed it to worsen around 1:00 AM today, which prompted her visit to the Emergency department. Tongue swelling/possible angioedema",Not Reported,,Yes,Yes,2.0,Not Reported,Y,02/26/2021,02/27/2021,1.0,PUB,"aspirin 81 mg chewable tablet 1 po daily cyanocobalamin (vit B-12) 1,000 mcg tablet TK 1 T PO QD. cyclobenzaprine 10 mg tablet EpiPen 2-Pak 0.3 mg/0.3 mL injection, auto-injector 0.3 mg SC/IM x1 dose with tongue swelling/choking/short",None,"adenomatous polyp of colon repeat colonoscopy 3/2022 backache benign essential hypertension cervical disc disorder followed by ortho, at C5-6 w/ radiculopathy chest pain on exertion chronic kidney disease stage 2 At last check , patient with progression to CKD 3. Oct 2020 - eGFR > 60 (71.6) depressive disorder diabetes mellitus essential tremor gastroesophageal reflux disease hyperlipidemia insomnia intermittent palpitations followed by cardio - cardio 9/2019 intervertebral disc disorder followed by ortho - lumbar region w/ radiculopathy, lumbar spondylolisthesis left bundle branch block followed by cardio, EF 40-45% obesity Type 2 diabetes mellitus without complication",,"Atorvastatin, Cipro, Lisinopril, metoprolol, avocado","['Atelectasis', 'Blood magnesium normal', 'Chest X-ray abnormal', 'Glomerular filtration rate', 'Intervertebral disc degeneration', 'Osteoarthritis', 'Red blood cell sedimentation rate increased', 'Swollen tongue', 'Urticaria']",2,MODERNA,IM 1072958,MD,72.0,M,"Patient was admitted for a scheduled vitrectomy surgery. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,,02/19/2021,02/25/2021,6.0,PVT,,,,,,['Vitrectomy'],2,MODERNA,IM 1072982,WI,58.0,F,"between the first dose on 1/20/21 a week later I experience pain under my left rib cage and trouble catching my breath which I thought was due to shoveling heavy snow, then received my 2nd dose on 2/9/21 and on 2/14/21 I couldn't breathe and pain was so intense and went to Hospital at 9:30 PM and stayed overnight",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/09/2021,02/14/2021,5.0,PVT,"Allegra, Pantoprazole, Linzess, Prednisone 10 Mg, Vitamin B-12, Vitamin D, Probiotic",I was experiencing pain under left side rib cage and alittle shortness of breath after first vaccine on 1/20/21,Liver inflammation (Autoimmune Cholangiopathy) Irritable Bowel syndrome,,"Sulfa meds, Penicillin, Raspberries, Fire Ants","['Chest pain', 'Computerised tomogram thorax abnormal', 'Condition aggravated', 'Dyspnoea', 'Electrocardiogram', 'Electrocardiogram abnormal', 'Fat necrosis', 'Inappropriate schedule of product administration', 'Myocardial necrosis', 'Pain', 'Scan with contrast abnormal']",2,PFIZER\BIONTECH,SYR 1072989,MD,75.0,F,"Patient admitted for nausea and vomiting as well as acute cystitis. Pt was treated with IVF, antiemetics, and antibiotics. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/02/2021,02/23/2021,21.0,PVT,,,,,,"['Cystitis', 'Nausea', 'Vomiting']",2,MODERNA,IM 1072991,SD,74.0,F,COVID-19 INFECTION 2/24/2021 ARDS,Not Reported,,Yes,Yes,7.0,Not Reported,Y,02/10/2021,02/23/2021,13.0,PUB,1) ALBUTEROL 3/IPRATROP 0.5MG/3ML INHL 3ML 2) ALBUTEROL 90MCG HFA MDI Qty: 8.5 3) ARFORMOTEROL 15MCG/2ML INH SOL 4) BENZONATATE 100MG CAP 5) CALCIUM ACETATE 667MG (CA 169MG) CAP 6) GUAIFENESIN 100MG/5ML SYRUP 7),ESRD Dialysis DM2 COPD CARDIOMYOPATHY,ESRD Dialysis DM2 COPD CARDIOMYOPATHY,,CODIENE,"['Acute respiratory distress syndrome', 'COVID-19', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1072993,FL,90.0,F,"Day After - severe headache, 2 days after headache continues, itchy scalp, day 3 rash visible at hair line headache continues, more confusion than normal, day 4 on site nurses check rash and think it is dermatitis, day 5 continues to get work nurse practitioner was to visit next day, day 6 NP thinks that she has UTI and sends her to hospital (2/11/21). Hospital determines - Rash is Shingles, UTI present, - MRSA is now present in shingles which is on right back of head and right neck and face. Next Sepsis is diagnosed. Since 2/11/21 patient was not conscious. 2/20/21 famiy is notified that she should be moved to Hospice. Moved to hospice on 2/20/21. The patient, my mother, died on 2/23/21 official cause of death is UTI.",Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,SEN,"Acetaminophen, amlodipine, centrum silver , citalopram, ferrous sulfate, gabapentin, lamotrigine, lorazepam, losartan, melatonin, mirtazapine, Montelukast sodium, polyethylene eye drops, risperidone, tramadol","Tic Douloureux, arthritis, anxiety","Tic Douloureux, arthritis, anxiety",,"Sulfur, laytex, pennecillin","['Confusional state', 'Death', 'Headache', 'Herpes zoster', 'Loss of consciousness', 'Pruritus', 'Rash', 'Sepsis', 'Staphylococcal infection', 'Urinary tract infection']",2,PFIZER\BIONTECH,IM 1073044,GA,85.0,M,I do not know more details of patient's death. Contact Funeral Home to obtain more information.,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/26/2021,03/01/2021,3.0,UNK,unknown,unknown,"Patient died on 3/1/2021 after receiving the second vaccination of an mRNA COVID-19 vaccine on approx. 2/26/2021. Patient began feeling ill not long after the vaccination, and his condition progressively deteriorated until he was taken to a hospital, where he died on 3/1/2021.",,unknown,"['Death', 'General physical health deterioration', 'Malaise']",UNK,UNKNOWN MANUFACTURER, 1073047,WI,79.0,M,"Patient recieved 2nd dose COVID vaccine and had unresponsive episode in car after monitoring period, staff assessed in car and patient had recovered, staff encouraged family to take to ED for evaluation. From ER MDs note: EKG was normal sinus rhythm, narrow QRS, delayed transition, minimal lateral st depression V4. Patient IV access on arrival, would Brady down to the 40s 1 time as low as 27 but remained alert, blood pressure is not dip. Troponin was mildly elevated and decision was made to transfer the patient. Prior to transfer is necessary to rule out pulmonary embolism, intracranial injury Patient wished to proceed with CT angio chest and noncontrast CT of head which were without acute findings. Patient given aspirin 81 mg to supplement the 81 mg he had earlier today. Discussed with hospitalist, patient was accepted in transfer. Suspect this is combination of patient's beta blockade with underlying sinus node dysfunction. Patient does have prominent lower extremity swelling and suspect pulmonary hypertension despite treatment with CPAP but cannot exclude valvular heart disease. Patient was went to Hospital. Symptoms thought to be unlikely from seizure. Doubt CVA, ongoing cardiac ischemia.",Not Reported,,Not Reported,Yes,,Not Reported,U,03/03/2021,03/03/2021,0.0,PVT,,,,,,"['Angiogram', 'Angiogram pulmonary normal', 'Bradycardia', 'Computerised tomogram head normal', 'Continuous positive airway pressure', 'Electrocardiogram abnormal', 'Electrocardiogram normal', 'Peripheral swelling', 'Pulmonary hypertension', 'Sinus node dysfunction', 'Troponin increased', 'Unresponsive to stimuli']",2,MODERNA,IM 1073053,CO,30.0,F,I have a mass in my neck the size of a potato you guys need to make it easier to get in contact with people when crazy things happen because of the vaccine. This is day 7 in the ER straight after failed medicine and a failed surgery. They finally got the white blood cell count to come down after a week.,Not Reported,,Yes,Yes,7.0,Not Reported,N,02/11/2021,02/13/2021,2.0,PVT,None,None,None,,None,"['Haematocrit normal', 'Haemoglobin normal', 'Mean cell volume normal', 'Neck mass', 'Platelet count normal', 'Red blood cell count normal', 'Red cell distribution width normal', 'Surgery', 'White blood cell count increased']",1,PFIZER\BIONTECH,SYR 1073060,WI,88.0,F,"She had weakness to the point she wasn't able to bear weight on her extremities, confusion, chills, emesis,and fatigue. She was sent to ER @ Hospital. Continues with confusion and weakness as of 3/4/2021.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/25/2021,02/27/2021,2.0,SEN,,none,Diabetic,,,"['Acute kidney injury', 'Asthenia', 'Chills', 'Confusional state', 'Fatigue', 'Laboratory test abnormal', 'Vomiting', 'Weight bearing difficulty']",UNK,MODERNA,IM 1073076,MI,22.0,M,No reaction occurred from time of administration (0830) to 1600. Intense emesis and stomach pain then began. Patient self-administered 100mg IM hydrocortisone. Blood pressure monitored via home monitor quickly decreased and heartrate increased. At 2000 on 3/2 EMS was engaged and brought patient to Hospital Emergency Department. At emergency room patient was diagnosed with acute adrenal crisis and given multiple doses of hydrocortisone 50mg and promethazine 12.5mg. At least three 1000ml NS boluses were provided in ED. Blood pressure continued to drop; lowest noted was low 80s/30s. Admitted to cardiology unit for continued observation and steroid/antiemetic support. Patient remained admitted 3/3 and was discharged 3/4 following adequate fluid resuscitation and transition to PO steroids.,Not Reported,,Yes,Yes,3.0,Not Reported,Y,03/02/2021,03/02/2021,0.0,WRK,"Hydrocortisione 10mg BID; Hydroxyzine 50mg BID, Calcium Carbonate 600mg BID, Cromolyn Sodium 200mg QID, Cholecalciferol 5000 IU every other day, 1/2 scoplamaine patch every 3 days.",,"Adrenal insufficiency, mast cell activation syndrome, dysautonomia, Ehlers-Danols Syndrome",,"Numerous allergies to foods and medications. Including corn, wheat, dairy, nuts, meat, soy, and assorted fruits and vegetables. Medication allergies include antibiotics (desensitization performed when required), diphenhydramine.","['Abdominal pain upper', 'Adrenocortical insufficiency acute', 'Blood lactic acid', 'Blood pressure decreased', 'Electrocardiogram', 'Fluid replacement', 'Full blood count', 'Heart rate decreased', 'Heart rate increased', 'Lipase', 'Metabolic function test', 'Steroid therapy', 'Vomiting']",1,MODERNA,IM 1073077,OH,75.0,F,leg weakness and loss of control of legs that lasted about 24 hours. spouse had to pick her up for transfers. there was some muscle activation in legs but not coordinated (knee would move but foot wouldn't move at the right time). self-resolved. also some brain fog and confusion,Not Reported,,Not Reported,Not Reported,,Yes,Y,02/28/2021,02/28/2021,0.0,PHM,"metformin, glipizide, acarbose, amlodipine,levothyroxine, atorvastatin, quinapril","COVID-19 pneumonia requiring hospitalization, starting 12/15/2020. her COVOD symptoms included delirium and leg weakness along with respiratory symptoms","type 2 diabetes, hypothyroidism, hypertension , hyperlipidemia,",,none,"['Condition aggravated', 'Confusional state', 'Feeling abnormal', 'Loss of control of legs', 'Muscular weakness', 'Musculoskeletal disorder']",2,MODERNA,IM 1073091,WI,76.0,M,"Department was notified patient passed away on call back to confirm 2 dose appointment scheduled on February 27, 2021 to receive the COVID-19 vaccine. Department unaware of patients cause of death.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,02/27/2021,31.0,PUB,,,,,,['Death'],1,MODERNA,IM 1073096,MD,79.0,M,"Patient was admitted for possible GI bleed. He was seen by GI who suspected that bleeding was due to hemorrhoids. Patient was discharged and advised to follow up with PCP and GI. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/24/2021,02/24/2021,0.0,PVT,,,,,,"['Gastrointestinal haemorrhage', 'Haemorrhoids']",1,PFIZER\BIONTECH,IM 1073099,PA,75.0,M,BP 80/40 Cold sweats HR racing onset of A FIB,Not Reported,,Yes,Yes,1.0,Not Reported,Y,03/01/2021,03/01/2021,0.0,PVT,,Stroke due to A fib,,,NKDA,"['Atrial fibrillation', 'Cold sweat', 'Hypotension', 'Palpitations']",2,MODERNA,SYR 1073108,SD,82.0,F,"Pt was hospitalized due to positive COVID 19 and hypoxia from 2/2/21 and 2/5/21. Pt had a 4 day history of weakness, abdominal pain, and shortness of breath. Pt tested positive for COVID 19 and was hypoxic requiring hospitalization. Pt was treated with Remdesivir and Dexamethasone in hospital and weaned off oxygen at discharge. Py had CT of chest showing groundglass opacity. Pt had received her first Moderna COVID 19 vaccine previously on 1/26/21.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/26/2021,02/04/2021,9.0,PVT,"Ezetimibe, Famotidine, Insulin Aspart, Insulin Detemir, Synthroid, Lisinopril, Metoprolol, Rosuvastatin, Semaglutide, Venlafaxine, Aspirin",None noted.,"Diabetes, Heart disease, Hyperlipidemia, Hypothyroidism, diverticulosis, arthritis",,"Ciprofloxacin, Hydrocodone, Januvia, Lipitor, Oxycodone","['Abdominal pain', 'Asthenia', 'COVID-19', 'Dyspnoea', 'Hospitalisation', 'Hypoxia', 'Lung opacity', 'Oxygen therapy', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1073128,IL,95.0,F,"Expired within 30days of vaccination. Received vaccine 1/22/21 did not have any complaints, during a bed check she was found on the floor with no apparent injury, no pulse or respirations.",Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/23/2021,1.0,OTH,Unknown,"Fall at home with arm fracture, placed in Memory Care","Cardiac History, pacemaker",,Unknown,"['Death', 'Pulse absent', 'Respiratory arrest']",1,PFIZER\BIONTECH,IM 1073131,NC,88.0,M,Patient admitted to hospital and has tested positive for SARS-CoV-2 more than 3 week after the second dose of Vaccine,Not Reported,,Not Reported,Yes,,Not Reported,U,02/10/2021,03/03/2021,21.0,PVT,"aspirin 81mg daily, protonix 40mg daily",none,"coronary artery disease, hyperlipidemia, GERD, hypothyroid, ischemic cardiomyopathy",,"citalopram, duloxetine, mirtazapine, quinine","['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,UN 1073162,SD,78.0,F,"Pt had received dose 1 of COVID vaccine on 12/22/20. On 01/01/21 pt presented to the emergency department for intractable nausea, vomiting, cough, and non bloody diarrhea. Pt had tested positive for COVID 19 on 12/30/2020. Pt was spiking high fevers and was hypotensive. Pt was admitted to the hospital from 1/01-1/06 and treated with dexamethasone, remdesivir, and convalescent plasma.",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,12/22/2020,01/01/2021,10.0,PVT,"Hhydrochlorothiazide, Synthroid, Potassium Chloride",None noted,"Multiple myeloma, hypertension, hypothyroidism",,"Loevofloxacin, Sulfamethoxazole","['Blood potassium decreased', 'Blood sodium decreased', 'COVID-19', 'Convalescent plasma transfusion', 'Cough', 'Diarrhoea', 'Diarrhoea haemorrhagic', 'Escherichia test positive', 'Gastroenteritis Escherichia coli', 'Hypotension', 'Nausea', 'Platelet count decreased', 'Pyrexia', 'SARS-CoV-2 test positive', 'Vomiting']",1,MODERNA,IM 1073167,TX,54.0,F,She passed away 2/24/2021,Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/24/2021,13.0,PVT,"SOME OF THESE SHE WAS TAKING AND SOME SHE MAY NOT HAVE BEEN, List is from 2016. Metoprolol Omeprazole Duloxetine Valacyclovir Trazadone Tramadol HCL Cyclobenzaprine Augmentin",No,Hypertrophic obstructive Cardio myopathy Endocarditis,,No/Unknown,['Death'],1,PFIZER\BIONTECH,SYR 1073173,IA,73.0,F,"Moderna COVID-19 Vaccine EUA 2/27/21: Pt received 1st Moderna vaccine 2/4/2021. She states that her symptoms 1st started out as a slight postnasal drip, which turned into a hoarse voice with a cough, which turned into a head cold, which has turned in due shortness of breath, diarrhea, and cough with associated chills. After 17 days of cold-like symptoms, pt was tested on 2/26 for COVID and tested positive. 2/27, pt worsened and presented to ED. Upon arrival to the emergency department, the patient's temperature is 100.2� F, heart rate 96, respiratory rate 24, saturating 84% on room air with blood pressure 164/84. The patient's laboratory studies were significant for BUN 17, CR 1.47, lactate 2.2, D-dimer 6.79, and phosphorus 2.2. The patient's chest x-ray showed no acute findings. CT chest showed extensive acute bilateral pulmonary emboli involving most of the lobar and segmental branches, right greater than left with no saddle embolus. Findings borderline for right heart strain, correlate with echocardiogram. Peripheral ground-glass airspace opacities consistent with atypical/viral pneumonitis. Reactive mediastinal and hilar lymphadenopathy. EKG showed normal sinus rhythm, heart rate 93 with inferior infarct-age undetermined. The patient was administered 1 L IV NS, ceftriaxone 1 g IV, azithromycin 500 mg IV, and heparin IV bolus and drip for PE indication. Remdesivir started. 2/28/21: Pt on 3 L oxygen. Azithromycin, ceftriaxone, remdesivir continued. Vancomycin started. 3/1/21: 1 L oxygen via nasal cannula. Small, nonproductive cough. Pt complains of SOB. 3/2/21: 1/2 blood cultures from 2/27 positive for CoNS. Vancomycin discontinued. Pt feeling much better. Still on 1 L oxygen via nasal cannula. More alert. 3/3: 5 day remdesivir course and azithromycin, ceftriaxone course completed. Patient weaned off oxygen. Pt discharged home with oxygen as a precaution. Pt also enrolled in COVID Safe At Home telehealth program.",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,02/04/2021,02/10/2021,6.0,PVT,Acetaminophen 650 mg PO Q8h PRN Amlodipine 10 mg PO QD Ascorbic acid 500 mg PO BID Cholecalciferol 1000 mg PO QD Dapagliflozin 5 mg PO QD Furosemide 20 mg PO QD Guaifenesin 1200 mg ER PO Q12h PRN Irbesartan 300 mg PO QD Metformin 500 mg PO,,Diabetes mellitus,,NKA,"['Blood creatinine increased', 'Blood culture positive', 'Blood lactic acid decreased', 'Blood phosphorus', 'Blood phosphorus decreased', 'Blood urea normal', 'Body temperature increased', 'COVID-19', 'Chest X-ray normal', 'Chills', 'Computerised tomogram thorax abnormal', 'Cough', 'Diarrhoea', 'Dysphonia', 'Dyspnoea', 'Electrocardiogram abnormal', 'Electrocardiogram normal', 'Fibrin D dimer increased', 'Hilar lymphadenopathy', 'Lymphadenopathy mediastinal', 'Nasopharyngitis', 'Oxygen saturation decreased', 'Pneumonitis', 'Pulmonary embolism', 'SARS-CoV-2 test positive', 'Tachypnoea', 'Upper-airway cough syndrome']",1,MODERNA, 1073215,CA,26.0,F,"I first started feeling very cold around 5:00 PM that day. Once I went home I went to sleep around 10:30 and work up at 2:30 AM with vomiting and 8/10 epigastric pain that radiated to my back. I went to the hospital. They gave me morphine and Zofran but within 5 minutes of the first dose of morphine, my pain returned even more intense and I still vomited 20 minutes after the Zofran. So they pushed another Morphine and Zofran. Zofran helped at this point but the Morphine did not. At this point they gave my three different oral liquids to help calm down my epigastric region, including mylanta, lidocaine and a third medication. I went home and slept the rest of the day but Wednesday night I got diarrhea and spike a fever of 102.7 around 8PM. Now it's thursday morning and I still have a 2/10 epigastric pain, physically exhausted and had a fever this morning as well.",Not Reported,,Not Reported,Yes,,Not Reported,N,03/02/2021,03/02/2021,0.0,OTH,Birth control pills,No illness at the time of vaccination or up to one month prior,"No health conditions. I have Factor V Leiden, but it has not ever caused an issue for me.",,Iodine. No other allergies,"['Abdominal pain upper', 'Back pain', 'Blood test normal', 'Diarrhoea', 'Fatigue', 'Feeling cold', 'Pain', 'Pyrexia', 'Somnolence', 'Ultrasound scan normal', 'Urine analysis normal', 'Vomiting']",2,MODERNA,IM 1073219,MA,24.0,F,"nausea, headache, lethargic, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/04/2021,0.0,PVT,"sertraline, montelykast, sprintec, claritin, B12, elderberry, apple cider vinegar, cranberry, Multivitamin",,asthma,,,"['Chills', 'Headache', 'Lethargy', 'Nausea']",UNK,JANSSEN, 1073225,IL,73.0,M,"Death within 30 days: Admit 2/8/21-2/13/21 s/p fall with left hip fracture (repaired), severe debility with recurrent falls discharged to SNF. Not doing well postop at the SNF, brought to ED due to failed foley insertion with bright red blood upon arrival to ER febrile, hypotensive, tachycardic, severe sepsis. Gran negative bacteremia likely from chronic ascites, family decided on comfort care and he expired within hours of admission.",Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/22/2021,20.0,OTH,"Tylenol with codeine, albuterol, aspirin, cetirizine, dialyvite, dilaudid, fluticasone, furosemide, multivitamin, glucosamine, lactulose, lantus, nystatin, omeprazole, spironolactone, tramadol, vitamin e, xifaxan",Chronic Illness with debilitation,"chronic hyponatremia, chronic low back pain, ascites, cirrhosis of liver, non-alcoholic fatty liver, dyslipidemia, diabetes, esophageal varisces. obstructive sleep apnea",,NSAIDS,"['Ascites', 'Asthenia', 'Bacteraemia', 'Catheter site haemorrhage', 'Complication associated with device', 'Condition aggravated', 'Death', 'Fall', 'Haemorrhage', 'Hip fracture', 'Hip surgery', 'Hypotension', 'Sepsis', 'Tachycardia']",1,MODERNA,IM 1073239,ND,73.0,F,"She was in her usual state of health until January 26 when she received her first dose of the Pfizer COVID-19 vaccine and the second dose on February 18, 2021. Within 4 days of receiving this vaccine she noticed she fell on Monday, February 22 she was able to raise herself up she fell again on Tuesday, February 23 and on Thursday, February 24. By Friday she could not get up and she presented to hospital where she was noted to have lower extremity weakness. An MRI has revealed extensive edema of the whole of the spinal cord extending from the cervical region to the sacral area. She has lost motor function and sensation to the lower extremities as well. She has not had a bowel movement since Thursday, February 24 and she has had to have a Foley catheter placed because of difficulties passing urine.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/18/2021,02/22/2021,4.0,PUB,"Iron-Vitamin C (Iron 100/C) 100-250 MG Tablet Take by mouth. � � 2/26/2021 at Unknown time ? vitamin D3, cholecalciferol, 25 mcg (1000 units) tablet Take 2,000 Units by mouth one time a day. � � 2/25/2021 at Unknown time ? hydrocortisone",Hypertension Dyslipidemia Obesity Hashimoto's Hypothyroidism Factor V Leiden deficiency,,,Cephalexin Clindamycin Penicillins Sulfa Drugs,"['Bladder catheterisation', 'CNS ventriculitis', 'Computerised tomogram abdomen normal', 'Computerised tomogram pelvis abnormal', 'Computerised tomogram thorax normal', 'Constipation', 'Dysuria', 'Fall', 'Magnetic resonance imaging abnormal', 'Magnetic resonance imaging head abnormal', 'Magnetic resonance imaging neck', 'Magnetic resonance imaging spinal abnormal', 'Mobility decreased', 'Motor dysfunction', 'Muscular weakness', 'Red blood cell sedimentation rate increased', 'Sensory loss', 'Spinal cord oedema']",2,PFIZER\BIONTECH,IM 1073252,IL,73.0,F,Death within 30 days of vaccine,Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,03/01/2021,12.0,OTH,,,"5/18/2020 Diagnosed with invasive ductal carcinoma of the breast, elected not to treat",,,['Death'],1,PFIZER\BIONTECH,IM 1073268,,62.0,U,"Client received an unknown dosage due to improper vaccine draw. Nurse administered 7 doses in one vial - Janssen vial contains only 5 doses, 6 doses maximum. Other client's dosage verified by myself or other nurse leads.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/04/2021,03/04/2021,0.0,PUB,,,,,,['Incorrect dose administered'],1,JANSSEN,IM 1073280,,68.0,U,"Client received an unknown dosage due to improper vaccine draw. Nurse administered 7 doses in one vial - Janssen vial contains only 5 doses, 6 doses maximum. Other client's dosage verified by myself or other nurse leads.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/04/2021,03/04/2021,0.0,PUB,,,,,,['Incorrect dose administered'],1,JANSSEN,IM 1073283,IL,71.0,F,Death within 30 days of vaccination,Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,03/01/2021,18.0,OTH,,"2/2/21 New diagnosis of breast cancer and sarcoma left thigh and CT positive for 9mm Right middle lobe nodule, no treatments started prior to vaccine.",,,,['Death'],1,PFIZER\BIONTECH,IM 1073285,,82.0,U,"Client received an unknown dosage due to improper vaccine draw. Nurse administered 7 doses in one vial - Janssen vial contains only 5 doses, 6 doses maximum. Other client's dosage verified by myself or other nurse leads.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/04/2021,03/04/2021,0.0,PUB,,,,,,['Incorrect dose administered'],1,JANSSEN,IM 1073293,,81.0,U,"Client received an unknown dosage due to improper vaccine draw. Nurse administered 7 doses in one vial - Janssen vial contains only 5 doses, 6 doses maximum. Other client's dosage verified by myself or other nurse leads.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/04/2021,03/04/2021,0.0,PUB,,,,,,['Incorrect dose administered'],UNK,JANSSEN,IM 1073297,IA,87.0,F,"Patient was found by husband in respiratory distress on 3/3/21 with inability to arouse and agonal breathing. Intubated and sedated and brought to facility. Possible aspiration pneumonia, as patient vomited prior to intubation. Unknown if related to vaccine",Not Reported,,Yes,Yes,2.0,Not Reported,N,03/01/2021,03/03/2021,2.0,PUB,Fentanyl patch PEG Albuterol Oxycodone Bisacodyl Lorazepam Tylenol Albuterol-ipratropium Zofran Levothyroxine Ropinerole,Chronic,Anxiety/depression COPD Chronic pain/osteoarthritis Dementia Hypothyroidism RLS,,NKA,"['Agonal respiration', 'Blood gases', 'Chest X-ray', 'Computerised tomogram head', 'Depressed level of consciousness', 'Electrocardiogram', 'Endotracheal intubation', 'Laboratory test', 'Respiratory distress', 'Sedative therapy', 'Unresponsive to stimuli', 'Vomiting']",UNK,MODERNA,IM 1073327,GA,65.0,M,TIA stroke like sysmptom went to ER hospitalized Goa a day in hospital,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/11/2021,02/18/2021,7.0,PVT,Levothyrixine .112mcg 1per day Trazadone 50mg 1/day Taltz 1 shot/month for psoriasis Crestor 20mg 1/day Omerapazole as needed Vitamin D. 50000 once per week Vitamin B-12 1000 1/day Clobetasol ointment as needed Maloxicam 1/ day Tylenol,Psoriasis Arthrrities Lower back and neck pain,Psoriasis,,Penicillin Gluten and dairy allergy,"['Computerised tomogram normal', 'Echocardiogram', 'Magnetic resonance imaging head normal', 'Neurological symptom', 'Transient ischaemic attack', 'Ultrasound scan normal']",2,PFIZER\BIONTECH,SYR 1073338,KY,79.0,M,"patient received moderna covid-19 vaccines on 1/22/2021 and 2/24/2021. he presented to the ED on 2/26/21 with fall and shortness of breath. patient had been generally weak and having difficulty ambulating for some time and was worse the last 2-3 days. patient fell in the evening and could not get back up due to weakness. he was found the following morning and EMS was called. patient was brought to the ED. he was admitted for acute respiratory failure with hypoxia, COPD, pneumonia, NSTEMI, and rhabdomyolysis. also treated for type 2 DM, HTN, and paroxysmal atrial fibrillation. some concern that covid-19 vaccine may have contributed to the patient's rhabdomyolysis. per physician note on 3/3/2021: ""Covid 19 infection November 2020, got vaccinated in mid January and then again in February and got a bad reaction which was somewhat to be expected to lead to more marked myalgias and muscle weakness left him lying on the floor unable to get up and he developed rhabdomyolysis."" patient is still currently admitted, though CK levels have improved.",Not Reported,,Not Reported,Yes,,Not Reported,,02/24/2021,02/26/2021,2.0,PUB,"home medication listed in chart: albuterol, aspirin, atorvastatin, centrum, fluticasone-salmeterol, folic acid, fosinopril, furosemide, gabapentin, hydroxyzine, ibuprofen, metoprolol, montelukast, potassium chloride, saw palmetto fruit, ser","was seen by PCP on 2/8/21 for fatigue. note states ""suspect due to covid infection and deconditioning."" did have covid-19 infection in 11/2020.","chronic illnesses being managed by PCP include HTN, DM, venous insufficiency, low back pain, and obesity (BMI 42). ED provider noted history of atrial fibrillation, COPD, CAD, HTN, and LUTS.",,only allergy listed is codeine with reaction of nausea,"['Acute myocardial infarction', 'Acute respiratory failure', 'Asthenia', 'Atrial fibrillation', 'Blood creatine phosphokinase increased', 'Chronic obstructive pulmonary disease', 'Condition aggravated', 'Dyspnoea', 'Dysstasia', 'Fall', 'Gait disturbance', 'Hypertension', 'Hypoxia', 'Mobility decreased', 'Muscular weakness', 'Myalgia', 'Pneumonia', 'Rhabdomyolysis', 'Type 2 diabetes mellitus']",2,MODERNA,IM 1073344,IL,102.0,F,patient died.,Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/17/2021,18.0,SEN,"cardizem, metformin, dyazide, pottassium, remeron, seroquel",,,,NKA,['Death'],1,MODERNA,IM 1073361,IL,106.0,F,passed away,Yes,02/19/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/19/2021,25.0,SEN,"allopurinol, iron, cytomel, duoneb, prilosec, levothyroxine",,,,"PCN, ASA, Amantadine, IVP dye",['Death'],2,MODERNA,IM 1073369,IL,58.0,F,"After vaccine, patient developed persistent cough, shortness of breath, and fevers. Was diagnosed with COVID via POCT on 2/25/21 and was discharged from ED given lack of symptoms. Returned 2/27/21 after oxygen saturation found to be ~50% at home. Admitted for severe COVID infection requiring dexamethasone and remains inpatient.",Not Reported,,Yes,Yes,5.0,Not Reported,N,02/10/2021,02/25/2021,15.0,PVT,None,None,Obesity,,None,"['COVID-19', 'COVID-19 pneumonia', 'Cardiomegaly', 'Chest X-ray abnormal', 'Cough', 'Dyspnoea', 'Hospitalisation', 'Oxygen saturation decreased', 'Pyrexia', 'Steroid therapy']",UNK,PFIZER\BIONTECH,IM 1073390,NM,70.0,F,"couple of hours after receiving the injection, I had a large hive on my mid chest area. Later I had one on my hip. I was not concerned as I have them on occasion. I felt fine. Went to bed that evening and woke up with extreme burning and itching in my index finger and thumb of my right hand. Also a very large hive on the inside of my arm about 2 1/2 inches from my wrist bend. Intense itching. I took a Benadryl tablet and felt better almost immediately. Later in the day about 6 1/2 hours later, I had more itching on my hip where the high was located. I took another Benadryl. I am fine. I also call my doctor and reported it.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/03/2021,03/03/2021,0.0,PVT,Atorvastatin Losartin Qvar,sinus infection,asthma,,adhesive tape latex some dental s�dations bee wasp stings pollen,"['Burning sensation', 'Pruritus', 'Urticaria']",1,JANSSEN,SYR 1073412,FL,79.0,F,Initial flulike symptoms with fever Tues -Friday. Had a right side stroke 6 AM Saturday morning . Rushed to hospital and had a procedure involving a catheter through the body to the clot in the brain. Came out of that with a weekend left side and was medicated through Sunday night. At 10:30 PM Sunday night had a second stroke on the right side. Did not wake from that. Now I?m not expected to survive.,Not Reported,,Yes,Yes,6.0,Not Reported,N,02/23/2021,02/24/2021,1.0,OTH,Gummy vitamins,None,None,,Sulfur,"['Catheter placement', 'Cerebrovascular accident', 'Coma', 'Computerised tomogram', 'Influenza like illness', 'Laboratory test', 'Magnetic resonance imaging', 'Pyrexia', 'Thrombosis', 'Ultrasound scan']",2,MODERNA,IM 1073418,OK,43.0,F,GIVEN THE JANSSEN VACCINE. EUA. THE PATIENT STARTED DEVELOPING A RASH IMMEDIATELY AFTER VACCINATION AND SHE STARTED TO FEEL ITCHY. SHE WAS GIVE 25MG OF BENADRYL ORALLY AND WATCHED FOR 30 MINUTES.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,PUB,BENADRY GIVEN AFTER VACCINATION,,LUPUS,GIVEN 1ST DOSE PFIZER VACCINE ON 12/16/2020 AND DEVELOPED A RASH. DID NOT GET THE 2ND DOSE,"PFIZER, CODEINE, LATEX","['Immediate post-injection reaction', 'Pruritus', 'Rash']",1,JANSSEN,IM 1073431,NJ,56.0,M,"According to NJIIS registry, patient received Moderna dose 1 at ""Rite Aid 00994"" on 3/3/2021. Patient arrived in ED on 3/4/21 at approx 9AM via ambulance. ED physician note: ""56-year-old male brought in by EMS intubated with CPR in progress. It was reported that he arrived to work and then passed out. CPR was initiated almost immediately. BLS determined that he was pulseless and AED was applied. He was defibrillated twice. He was then intubated by ALS and administered epinephrine twice with return of spontaneous circulation. He maintained a pulse for approximately 20 minutes when he again developed cardiac arrest. ACLS guidelines were again initiated and there was no return of pulse for approximately 20-25 minutes until he arrived in the emergency department. Emergency department CPR was continued and he was administered an additional epinephrine with return of a pulse. Is reported that he had no complaints prior to the event."" Patient was intubated and ventilated, started on norepinephrine drip in ED. Twelve-lead EKG demonstrated right bundle branch block with left posterior fascicular block and diffuse QRS widening and diffuse repolarization abnormalities. Family consented to Cath Lab. Per Interventional Cardiologist note:� ""1. Angiography demonstrated proximal to mid LAD hazy 90-95% lesion likely culprit for cardiac arrest. 1 stent placed. �2. Diffuse distal right coronary disease that is likely nonculprit for cardiac arrest. �3. Left ventriculography demonstrated severe anterior wall hypokinesis with overall left ventricular ejection fraction of 40%. �4. Patient electrically and hemodynamically stable. Levophed has been stopped. Amiodarone bolus given in the Cath Lab for frequent ventricular ectopy. No drip was continued due to resolution of ectopy. �5. Dyslipidemia he will be on high-dose statin therapy. �6. Diabetic management as per primary team. �7. Quad-Lumen placed by me. Hypothermia protocol to be initiated in the ICU given GCS score less than 8 with no purposeful movements. Head CT scan completed before cardiac catheterization that demonstrated diffuse cerebral edema. �8. Prognosis guarded and likely poor. The next 24 to 40 hours will be critical. Family was updated in detail."" Patient transferred to ICU post Cath Lab. Remains intubated, ventilated in ICU. �",Not Reported,,Yes,Yes,,Not Reported,N,03/03/2021,03/04/2021,1.0,PVT,Glyburide-metformin 5/500- take 2 tablets twice daily with meals lisinopril 5 mg PO daily pioglitazone 30 mg PO daily simvastatin 20 mg PO daily,,diabetes type 2,,none,"['Angiogram', 'Brain oedema', 'Bundle branch block left', 'Bundle branch block right', 'Cardiac arrest', 'Cardioversion', 'Catheterisation cardiac', 'Coma scale abnormal', 'Computerised tomogram head', 'Computerised tomogram head abnormal', 'Dyslipidaemia', 'Electrocardiogram', 'Electrocardiogram abnormal', 'Endotracheal intubation', 'Epinephrine', 'Intensive care', 'Loss of consciousness', 'Pulse absent', 'Resuscitation', 'Stent placement']",1,MODERNA,IM 1073435,NM,58.0,M,"Patient received dose 1 and dose 2 of the COVID 19 vaccine, 2/2/21 (Lot EL9265, Pfizer) and 2/24/21 (Lot EN6202, Pfizer), on 2/28/21 patient presented to the Emergency Department at our facility. CBC lab test was abnormal, possible Leukemia, patient transferred to Medical Center for further evaluation and treatment. Patient expired on March 2, 2021.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/02/2021,02/28/2021,26.0,PVT,Unknown,Unknown,"Hypertension, Hyperlipidemia",,Unknown,"['Death', 'Full blood count abnormal', 'Liver function test abnormal', 'Serum ferritin abnormal']",1,PFIZER\BIONTECH,SYR 1073470,OH,,M,"vertigo; dizziness; trembling; throwup; terrible right hip pain; A spontaneous report was received from a consumer who was also a 70-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vertigo, dizziness, trembling/tremor, throw up/vomiting, terrible right hip pain/arthralgia. The patient's medical history was not included. Products known to have been used by the patient were not provided. On 12 February 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 031mz0) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 14 February 2021, approximately two days after the mRNA-1273 vaccine was given, the patient experienced vertigo, dizziness, trembling, and throw up. He reported being hospitalized for these symptoms. On 16 February 2021, he reports that he is feeling much better, but is experiencing terrible hip pain. Consent to contact was provided. Treatment information was not provided. Action taken with mRNA-1273 was not reported. The outcome of the events, vertigo, dizziness, trembling, throw up, and terrible hip pain, were considered unknown.; Reporter's Comments: This case concerns a 70 year old male patient, who experienced a serious unexpected event of vertigo, dizziness, and tremor among others, 3 day after receiving first dose mRNA- 1273 (Lot# 031mz0). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/12/2021,02/14/2021,33.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical history not provided),,,"['Arthralgia', 'Dizziness', 'Tremor', 'Vertigo', 'Vomiting']",1,MODERNA,OT 1073471,,,M,"Was found deceased a little less than 12 hours following COVID vaccination; A spontaneous report was received from a reporter concerning a 96-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was found deceased a little less than 12 hours following COVID vaccination. The patient's medical history included hospice care. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient was found deceased a little less than 12 hours following COVID vaccination, and he had had some changes over the last two days. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. On an unknown date the patient died. The cause of death was unknown. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a 96 year old male patient, who was on hospice care experienced a fatal event of death, after receiving mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,Hospice care,,,,['Death'],1,MODERNA,OT 1073472,MD,55.0,M,"Mild case of pneumonia; Tested positive for COVID; Shortness of breath; A spontaneous was received from a healthcare facility staff member concerning 55 years of old, male patient who developed shortness of breath, mild case of pneumonia and tested positive for COVID. The patient's medical history included back issue. The patient had an epidural for bulging disk in back in an unknown date in December. Concomitant product use was not provided by the reporter. On 29-JAN-2021, eight days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on left arm for prophylaxis of COVID-19 infection. On 20-JAN-2021, the patient had COVID symptoms including congestion and cough but tested negative on rapid testing. Since tested negative, the patient received first dose of Moderna COVID-19 vaccine as scheduled on 29-JAN-2021 at Hospital. On 06-FEB-2021 after experiencing shortness of breath, the patient was retested by rapid test, which was also negative. However, the patient tested positive for COVID on Polymerase Chain reaction test at Urgent Care. The patient had a mild case of pneumonia The reporter believes that the patient probably was positive before, as patient had been home since 19-DEC-2020 due to a back issue. Thinks that the patient's son may have been asymptomatic and all eight members in the household tested positive except the reporter. Treatment for the events included antibiotic azithromycin 5 days z-pack. The events shortness of breath, mild case of pneumonia and tested positive for COVID were considered recovered/resolved on an unknown date.; Reporter's Comments: Based on reporter's causality and high probability of corona infection from the close contacts where all eight members in the household were tested positive except the patient immediately before the vaccination, the event is assessed as unlikely related to mRNA-1273.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,02/06/2021,8.0,UNK,,,Medical History/Concurrent Conditions: Back disorder NOS; Epidural injection (For bulging disk in back in December.),,,"['COVID-19', 'Dyspnoea', 'Pneumonia']",1,MODERNA,OT 1073473,PA,,M,"Bells Palsy; Numbness in left side of face; A spontaneous report was received from a consumer who was also a 43 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced Bell's Palsy / facial paralysis and numbness in left side of face / hypoaesthesia. The patient's medical history was not provided. No relevant concomitant medications were reported. On 17 Feb 2021 at 3:15 pm, approximately 25 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection. On 17 Feb 2021, about 25 minutes after receiving the vaccination administration, the patient reported numbness on the left side of his face. His doctor informed him that he had Bell's Palsy and to take diphenhydramine. Consent to follow up from safety was provided by the patient. Action taken with the first dose of mRNA-1273 vaccine was not reported. The events, Bell's Palsy and numbness in left side of face, were ongoing at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,UNK,ZYRTEC ALLERGY,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"[""Bell's palsy"", 'Hypoaesthesia']",1,MODERNA,OT 1073474,FL,74.0,M,"Neuropathy that is affecting his balance; Neuropathy that is affecting his balance; Tingling; A spontaneous report was received from a consumer concerning a 74-year-old, male patient, who experienced neuropathy that is affecting his balance (neuropathy peripheral and balance difficulty), and tingling (paraesthesia). The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received his first of two planned doses of mRNA-1273 (Lot unknown) on unknown date. On 29-Jan-2021, prior to the onset of the events, the patient received his second of two planned doses of mRNA-1273 (Lot number: 029K20A) for prophylaxis of Covid-19 infection. The patient stated that at some point after receiving the second vaccine, he began experiencing neuropathy that affected his balance and caused tingling. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events, neuropathy that is affecting his balance and tingling, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Balance disorder', 'Neuropathy peripheral', 'Paraesthesia']",2,MODERNA,OT 1073475,CO,,F,"Not feeling great; Very nauseous/Extreme nausea; hallucinations; A spontaneous report was received from a consumer who was also a 51-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nauseous, minor hallucinations, kind of a rough night, and not feeling great. The patient's medical history included diabetes and multiple sclerosis. Products known to have been used by the patient, within two weeks prior to the event, included insulin glulisine, insulin degludec, fingolimod hydrochloride, and levothyroxine. On 14th Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. The patient reported she was very nauseous 11-12 hours after receiving the vaccination. She was not sure if she was having minor hallucinations or not due to the extreme nausea. On 15 Feb 2021, the patient was not feeling great. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event nausea was recovered on 17 Feb 2021. The outcome of the events, hallucinations and not feeling great, were unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events and the administration of the mRNA-1273 vaccine cannot be excluded. The event of nausea is consistent with the known safety profile of the vaccine and a causal association cannot be excluded",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/14/2021,02/14/2021,0.0,UNK,APIDRA; TRESIBA; GILENYA; LEVOTHYROXINE,,Medical History/Concurrent Conditions: Diabetes; Multiple sclerosis,,,"['Hallucination', 'Malaise', 'Nausea']",1,MODERNA,OT 1073476,NM,16.0,U,"16 YEAR OLD WAS ACCIDENTLY VACCINATED; A spontaneous report was received from other healthcare professional (Pharmacist) concerning a 16-years-old patient, received who Moderna's COVID-19 vaccine (mRNA-1273) accidentally. The patient's medical history was not provided. No relevant concomitant medications were reported. On 18 Feb 2021, the patient received their dose of mRNA-1273 (Batch Number: Unknown), intramuscularly in the shoulder for prophylaxis of COVID-19 infection. On 18 Feb 2021, 16 -years-old patient was accidentally vaccinated with the Moderna Covid-19 vaccine No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event 16 -years-old patient was accidentally vaccinated with the Moderna Covid-19 vaccine was considered recovered.; Reporter's Comments: This report refers to a case of a 16-year-old patient with Product administered to patient of inappropriate age for mRNA-1273, lot # unknown, with no associated adverse events. Event considered resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Product administered to patient of inappropriate age'],UNK,MODERNA,OT 1073477,,,F,"Injection that was given 7 days early; A spontaneous report was received from a consumer concerning a female patient, of unknown age, who reported that injection was given 7 days early/ MedDRA PT: inappropriate schedule of product administration. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received her first of two planned doses of mRNA-1273 (Lot number not provided) on an unknown date. On an unspecified date, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of Covid-19 infection. The patient stated that injection was given 7 days early. No further information was provided. Treatment information was unknown. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The event, injection was given 7 days early, was considered resolved.; Reporter's Comments: This report refers to a case of a female of unknown age with Inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated adverse events. The event, injection was given 7 days early, was considered resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Inappropriate schedule of product administration'],2,MODERNA,OT 1073478,WA,,U,"16 years old was accidentally given Moderna Covid-19 Vaccine; A spontaneous report was received from a health care professional concerning a 16-year-old patient who received Moderna's Covid 19 vaccine(mRNA1273) at an inappropriate age (dosing error-pediatric use) The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On an unknown date, the patient received first of two planned doses of mRNA-1273 (batch number-Unknown) intramuscularly on a n unknown day for prophylaxis of Covid-19 infection. A 16 year old patient was accidentally given the Moderna Covid-19 vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The outcome of the event, inappropriate age at vaccine administration were considered as recovered/resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273. There were no reported adverse events associated with this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history provided.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1073479,TX,,F,"second dose administered 16 days after the first dose; A spontaneous report was received from a consumer for a 78-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient received second dose after sixteen days after receiving the first dose of vaccine. The patient's medical history was not provided. The patient is allergic rogaine hair products, sulfur eyedrops, latex gloves and tape, ciprofloxacin hydrochloride (500mg), advil and cefalexin. Concurrent conditions included acid reflux, cholesterol, depression, glaucoma (both eyes), headache, hypertension, nausea, sinus disorder and sleep disorder. The concomitant medications included timolol maleate, latanoprost, atorvastatin, pantoprazole, trazodone, montelukast sodium, amlodipine, vitamin d3, acetylsalicylic acid and magnesium . On 04 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection. On 20 Feb 2021, sixteen days after receiving the first dose of vaccine, the patient's vaccination card was checked by the facility and mRNA-1273 (Lot number: 022M20A) was administered intramuscularly. Additionally, it was reported that the patient was registered to receive vaccine under County Group of Vaccination and County Public Health (CPH). Treatment information was not applicable. Action taken with mRNA-1273 was not applicable. The outcome of the event second dose administered 16 days after the first dose was considered resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of vaccine administration for mRNA-1273, lot # 012M20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,UNK,TIMOLOL MALEATE; LATANOPROST; ATORVASTATIN; PANTOPRAZOLE; TRAZODONE; MONTELUKAST SODIUM; AMLODIPINE; VITAMIN D3; ASPIRIN [ACETYLSALICYLIC ACID]; MAGNESIUM,,"Medical History/Concurrent Conditions: Acid reflux (oesophageal); Allergy (rogaine hair product, sulfur eye drops, latex, tape, Ciprofloxacin hydrochloride, advil, cefalexin.); Cholesterol; Depression; Glaucoma (Glaucoma (both eyes)); Headache; Hypertension; Nausea; Sinus disorder; Sleep disorder",,,['Inappropriate schedule of product administration'],2,MODERNA,OT 1073480,FL,,F,"AFIB; Chronic Heart failure; Asthma got out of control out of no where.; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine and was admitted to hospital for atrial fibrillation and chronic heart failure, a feeling of wasn't feeling well, Asthma got out of control out of nowhere. Patient's medical history was not provided, and concomitant medicines taken by the patient, within two weeks prior to the event was not provided. On 16 JAN 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 11 FEB 2021, the patient was admitted in hospital for atrial fibrillation and chronic heart failure, a feeling of wasn't feeling well and asthma got out of control out of nowhere and was discharged on 19 FEB 2021. Treatment was not provided. Action taken with mRNA-1273 was not reported. The outcome of the events, to hospital admission for atrial fibrillation and chronic heart failure, a feeling of wasn't feeling well, Asthma got out of control out of nowhere was unknown.; Reporter's Comments: Very limited information regarding this event of heart attack has been provided at this time. Patient's medical history, list of concomitant medications, onset date and clinical details of the event is lacking. Further information has been requested.",Not Reported,,Not Reported,Yes,9.0,Not Reported,Y,01/16/2021,02/11/2021,26.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Asthma', 'Atrial fibrillation', 'Cardiac failure chronic']",1,MODERNA,OT 1073481,IA,,F,"Did not feel well; pneumonia; Covid-19; trouble breathing well; a little tired for a couple of days; A spontaneous report received from a Consumer concerning, a 67-year-old age female patient who received first dose of the Moderna COVID-19 vaccine and developed a serious, medically important event of pneumonia, in addition to non-serious events of COVID positive test, dyspnoe (reported as trouble breathing) and malaise (reported as do not feel well). The patient's medical history included cancer, cough and fatigue. Patient's concomitant included Ibrance, Levofloxacin and Dexamethasone. On 01 FEB 2021 date, the patient received their first dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: 043L20A or 043620A) intramuscularly for prophylaxis of COVID-19 infection. Patient stated that she had a cough before receiving the vaccine which can be caused by cancer medication that she takes. She reported that she was also a little tired for a couple of days. Patient stated a week later on 10 FEB 2021, she saw her oncologist and let them know that she had trouble breathing well and did not feel well since the day before. Patient stated she was informed by the nurse that it's probably just a reaction to the vaccine. She stated she received her regular cancer treatment that day. Patient stated the following week on Tuesday 16 FEB 2021 she had trouble breathing and saw her primary doctor who diagnosed her with pneumonia and prescribed levofloxacin for 10 days and dexamethasone twice daily 7 days. She was also tested for COVID which came back positive. Patient provided consent to follow up with her. Treatment medication was prescribed by primary doctor (Levofloxacin and Dexamethasone). Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,UNK,LEVOFLOXACIN; DEXAMETHASONE,Cancer,Medical History/Concurrent Conditions: Cough; Fatigue,,,"['COVID-19', 'Dyspnoea', 'Fatigue', 'Malaise', 'Pneumonia', 'SARS-CoV-2 test']",1,MODERNA,OT 1073482,,,M,"Has some seriously bruises; knees locked up, lost his balance, lost control of his legs; knees locked up; lost his balance; A spontaneous report was received from consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, knees locked up, lost his balance, lost control of legs and some serious bruises. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 18-Feb-2021, six days later, patient reported that his knees locked up, he lost his balance and lost control of his legs. He stated that as of 22-Feb-2021, he has some serious bruises. Laboratory details were not provided. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable. The outcome of the events, knees locked up, lost his balance, lost control of legs and some serious bruises, was unknown.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of Loss of control of legs among others,7 days after receiving 2nd dose of mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/18/2021,6.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Balance disorder', 'Contusion', 'Joint lock', 'Loss of control of legs']",2,MODERNA,OT 1073483,AL,81.0,U,"Arrhythmia; A spontaneous report was received from a consumer who was an 81-year-old, male patient who was administered Moderna Covid-19 vaccine. The patient's medical history was not provided. No concomitant medications were reported. No information on allergies. On 21-Jan-2021, approximately four hours prior to the onset of events, patient received first of two planned doses of Moderna Covid-19 vaccine for the prophylaxis of Covid-19 infection. (Lot number unknown). On the same day, four hours after administration, patient experienced Arrhythmia and continued on and off for 4 days and stopped. It is not known that patient seek the treatment for the condition and details were not provided. Action taken with 2nd dose of vaccine is not reported. The outcome of the event Arrhythmia is resolved.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Arrhythmia'],1,MODERNA,OT 1073484,VA,,M,"Bilateral pulmonary emboli; A Spontaneous report was received from a consumer concerning a 90-Years-old male patient who received both doses of Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bilateral pulmonary emboli. The patient's medical history was not provided. NO Concomitant medication was reported On 15 Jan 2021, the patient received their first planned doses of mRNA-12 (lot no: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Feb 2021 prior to the onset of the events, the patient received their second planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient was hospitalized due to Bilateral pulmonary emboli. Treatment for the event included apixaban for blood thinning and Atorvastatin which was stopped a month before was restarted. The action taken with the drug in response to the event is unknown. At the time of this report, the outcome of the event Bilateral pulmonary emboli was considered resolved.; Reporter's Comments: This case concerns a 90-Years-old, male patient who experienced serious event of Bilateral pulmonary emboli. Treatment for the event included apixaban and Atorvastatin (which was stopped a month before) was restarted. Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/15/2021,02/16/2021,32.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical reported history),,,['Pulmonary embolism'],2,MODERNA,OT 1073485,MI,70.0,M,"Nausea; Chills; Cramps in intestines; Vomiting; Temperature of 99.4; muscle spasms; Headache; Felt lethargic; Felt tired; Dark urine like motor oil gold; like having a bad flu.; A spontaneous report was received from a Consumer concerning a 70-years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea. Patient went to bed and his muscles involuntary contracted and curled himself in a fetal ball The patient's medical history was not provided. Relevant concomitant medications were not reported. On 17-FEB-2021, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 18-FEB-2021, the patient experienced Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea. Patient went to bed and his muscles involuntary contracted and curled himself in a fetal ball. His wife took him to the ER at Hospital on the 18-FEB-2021 in the afternoon but patient decided that he would rather go home. The patients temperature was 99.4. Treatment information was provided as Tylenol for headache and Something for nausea and to relax muscles at the hospital. Action taken with mRNA-1273 in response to the events was not reported. On 18-FEB-2021, the outcome of the event's Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea was considered as unknown. At the time of this report, the outcome of the event's Muscle spasms, Abdominal pain, Vomiting, Chills, Headache, Lethargy, Fatigue, Pyrexia, Chromaturia, Influenza like illness and Nausea was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/17/2021,02/18/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Body temperature', 'Chills', 'Chromaturia', 'Fatigue', 'Gastrointestinal pain', 'Headache', 'Influenza like illness', 'Lethargy', 'Muscle spasms', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA, 1073486,FL,,M,"Tested positive fo COVID; Shortness of breath; Tired; No eating; Diarrhea; A spontaneous report was received from the wife of a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive for COVID (SARS-CoV-2 test positive) and experienced shortness of breath (dyspnoea), diarrhea, tired (fatigue), and no eating (decreased appetite) The patient's medical history was not provided. Concomitant product use was not provided. On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(lot/batch:030L20A) intramuscularly for the prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient experienced shortness of breath, diarrhea, tired, and no eating. He was hospitalized and tested positive for COVID. The patient was discharged on 21 Feb 2021. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events of tested positive for COVID, shortness of breath, diarrhea, tired, and no eating was unknown.; Reporter's Comments: Based on the information provided, a causal association between the reported events and the administration of mRNA-1273 vaccine is assessed as unlikely related The vaccine is not known to cause COVD infection. The other events are consistent with symptom of the disease.",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,01/28/2021,02/17/2021,20.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Decreased appetite', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'SARS-CoV-2 test positive']",1,MODERNA,OT 1073487,OH,81.0,F,"Had a stroke; A spontaneous report was received from a caregiver concerning an 81-years-old female patient who received Moderna's Covid-19 vaccine and had a stroke. Patient's medical history included a mini stroke (5-6 years ago). Concomitant medication included blood thinners. On 02 Feb 2021 at 4:30 pm, ten days prior to onset of the event stroke, the patient received the first of two planned doses of mRNA-1273 vaccine (Lot/batch: unknown) for prophylaxis of Covid-19 infection. On 11 Feb 2021, the patient had an event of stroke for which was hospitalized. The patient was on a lot of medications (not specified). Action taken with second dose of mRNA-1273 in response to the event was not recorded. The outcome of the event stroke was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of stroke, a causal relationship cannot be excluded. However, patient's elderly age and prior history of TIA are considered as risk factors.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/02/2021,02/11/2021,9.0,UNK,,,Medical History/Concurrent Conditions: TIA (5-6 years ago),,,['Cerebrovascular accident'],1,MODERNA,OT 1073488,FL,,F,"Believes that the syringe was not filled with any solution at the time of administration; A Spontaneous report was received from a consumer concerning a female patient (age not provided) who received Moderna (mRNA-1273) vaccine and believed that the syringe was not filled with any solution at the time of administration (vaccine underdose) The patient's medical history was not provided. No relevant concomitant medications was known. On 26-Jan-2020, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route, for prophylaxis of Covid-19 infection. The reporter stated that both of them have received the second dose and believed that his wife did not receive the full second dose ( believed that the syringe was not filled with any solution at the time of administration). Lab data was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of event was unknown.; Reporter's Comments: This report refers to a case of underdose for mRNA-1273 with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/26/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Underdose'],2,MODERNA, 1073489,IA,,M,"Vaccine was shaken up before vaccine was given; A spontaneous report was received from a consumer concerning a 78 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) vaccine was shaken up before vaccine was given (product administration error). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly] for prophylaxis of COVID-19 infection. On an unspecified date the vaccine was shaken before vaccine was given (product administration error). Action taken with mRNA-1273 in response to the event was not provided. The event product administration error was unknown.; Reporter's Comments: This case concerns a 78-year-old male who experienced nonserious unexpected event of Product administration error for mRNA-1273, lot # unknown, with no associated adverse events. Event outcome not reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Product administration error'],UNK,MODERNA, 1073490,TX,,U,"Vaccine spilled on patient's arm; I dont think patient received any dose; crack in syringe and vaccine spill; A spontaneous report was received from a healthcare professional concerning a patient on an unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and there was a crack in the syringe and the vaccine spilled on patient's arm and don't think the patient received any dose. The patient's medical history was not reported. No relevant concomitant medications were reported. On 08-feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 08-feb-2021, pharmacy intern called to ask for some guidance for an incident that happened in the pharmacy. When they were vaccinating one of the patients, there was a crack in the syringe and the vaccine spilled on patient's arm. They did not think the patient received any dose. They wanted to know regarding the 2nd dose of vaccine and should they wait 4 weeks for it, and can patient absorb any vaccine topically. Pharmacy intern didn't have any information about the patient because she wasn't the one who administered the vaccine. She said she will tell other people to report it. No treatment information was provided. Consent for follow up was not given. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events and there was a crack in the syringe and the vaccine spilled on patient's arm and don't think the patient received any dose were considered resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender who experienced NS unexpected events of Device connection issue, exposure via skin contact, and underdose with mRNA-1272 (lot # unknown) with no associated adverse events. Events considered resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse reaction (No medical history reported),,,"['Device connection issue', 'Exposure via skin contact', 'Underdose']",1,MODERNA,OT 1073491,OH,77.0,F,"I think they administered a vaccine that had expired the day before; A spontaneous report was received from a 77-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and thought that she was administered a vaccine that had expired the day before (PT: expired product used). The patient's medical history was not provided. No relevant concomitant medications were reported. On 05-FEB-2021, the patient received her first of two planned doses of mRNA-1273 (batch number# 13M20A, expiration date: 04-FEB-2021) through an unknown route in an unknown arm, for prophylaxis of COVID-19 infection. The patient believed that she was administered a vaccine that had expired. Treatment information was not provided. The outcome of the event was considered recovered on 05-FEB-2021.; Reporter's Comments: This refers to a case of 77-year-old female patient, who had an ""expired product administered"" of Moderna's COVID-19 vaccine (mRNA-1273)(Lot#13M20A ) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Expired product administered'],1,MODERNA, 1073492,CA,,F,"sore arm; Caller reported a vaccine recipient thought the first dose of the covid 19 vaccine was too high up on the arm so the vaccine administrator gave a second dose within 15 minutes.; Caller reported a vaccine recipient thought the first dose of the covid 19 vaccine was too high up on the arm so the vaccine administrator gave a second dose within 15 minutes.; This is a spontaneous report from a contactable Pharmacist. A female patient in her 20s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 27Jan2021,14:30 (lot number: unknown) and second dose on 27Jan2021, 14:40- 14:45 both via an unspecified route of administration in the arm at 0.3mL single dose for COVID-19 immunization in the clinic. The patient's medical history and concomitant products were unknown. The reporter, was a pharmacist, was a Depo leader with the pharmacy COVID-19 vaccine clinic. They had a clinic in one of the facilities. One of the patient who could have been a Nurse, or at least had medical background was the patient. The pharmacist at a pharmacy gave the patient 0.3mL of the Pfizer COVID vaccine. The patient claimed the Pharmacist gave it too high up, near her shoulder. The patient then went to a different Pharmacist because she felt like she didn't get her dose and got a second dose of 0.3mL within 15 minutes. The reporter doesn't know which arms they were given in. The reporter stated the patient had experienced sore arm. The pharmacist assessed the events as non-serious. The outcome of the event as unknown. Information on the lot/batch number has been requested. Follow-up (02Feb2021): New information reported from a contactable Pharmacist includes: new event (sore arm). Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,OTH,,,,,,"['Overdose', 'Pain in extremity', 'Product administered at inappropriate site']",1,PFIZER\BIONTECH, 1073493,SC,,F,"After 1st dose tested positive for Covid-19; After 1st dose tested positive for Covid-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient had first vaccine almost 21 days ago, after 1st dose tested positive for covid-19 on an unspecified date. The patient wanted to know if she should have 2nd dose. She stated she has finished her 10-day quarantine. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1073494,,,F,"nausea; vomiting; diarrhea; not feeling too good; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number ang expiry date unknown), via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she was not feeling too good since an unspecified date in 2021. She reported that on 31Jan2021, since she received the first dose she has woken up every morning with nausea, vomiting and diarrhea. She asked if this was normal and how long it will last. She was asking what is the efficacy of one dose of the vaccine and if should get the second dose. The outcome of the events was unknown. The events were reported as non-serious. Information about Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,01/31/2021,1.0,UNK,,,,,,"['Diarrhoea', 'Malaise', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH, 1073495,MD,75.0,F,"sore muscle around my neck; when in bed last night, she could not turn her head without it been so painful; had discomfort in her shoulder and stiffness; had discomfort in her shoulder and stiffness/neck was so stiff that it hurt to turn her/can hardly turn her neck; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264), via an unspecified route of administration on 30Jan2021 at 16:10 (4:10 pm) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 30Jan2021, the same night of vaccination, the patient had discomfort in her shoulder and stiffness. On Monday, 01Feb2021, patient reported that her ""neck was so stiff that it hurt to turn her head"". She can hardly turn her neck. She added when in an ""upright"" position ""it is ok"" but ""when in bed last night, she could not turn her head without it been so painful"" to the point where she felt like she ""would cry out"". On an unspecified date it was reported that patient had sore muscle around my neck. The patient mentioned she alleviates her pain with ""Tylenol, hot compresses, took a towel and put hot water on it and then put it around my neck, and a cream for soreness"". The patient took a Tylenol last night and put hot compress on it. And rubbed it with a muscle something for a sore muscle. But it still very painful. The patient doesn't know whether it's related to the vaccine or not. The outcome of the event sore muscle was not recovered while for the rest of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,UNK,,,,,,"['Headache', 'Musculoskeletal discomfort', 'Musculoskeletal stiffness', 'Myalgia']",2,PFIZER\BIONTECH, 1073496,TX,,F,"patient received the Covid vaccine below the deltoid muscle, possibly in the subcutaneous tissue.; patient had an injection induration at administration site.; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on the arm (also reported as below the deltoid muscle), on an unspecified date at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the COVID vaccine below the deltoid muscle, possibly in the subcutaneous tissue. It was asked if there is a need for revaccination. Patient also had an injection induration at administration site. The outcome was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Product administered at inappropriate site', 'Vaccination site induration']",1,PFIZER\BIONTECH, 1073497,MD,71.0,M,"Sore throat; Cough; had strep, his throat is sore; He had a low grade fever; Fatigue/Exhausted/tired; He is not feeling well; Chills; Headaches; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the second (husband) of two reports. A 71-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 71-year-old via an unspecified route of administration on 27Jan2021 at a single dose for didn't want to get COVID (covid-19 immunization). The patient's no medical history and concomitant medications. The wife reported that they both received their first dose for the Pfizer Covid vaccine on 27Jan2021 and since then they have experienced ""major side effects, chills, headaches, sore throat, major cough, fatigue"" that was just unbelievable and both of them are exhausted on 27Jan2021. She further stated that they both got sick: had a major headache, cough, and chills. She mentioned that the major headache started as soon... he went back to work, and said he is not feeling well so he came home, and he hopped in bed. He got under the covers around 4PM and he had a low-grade fever, it was nothing, a little bit, and her went to bed and then he said he had a headache, his happened immediately. He also had chills on the same day and had the cough immediately. She added that the headache has gone away which lasted like one day, his cough was ongoing though improving, but he still has one. Chills went away, they lasted a couple days, he has recovered completely. She reported that what was unusual, she was looking at side effects, but he had a major sore throat that started that day (27Jan2021) and he still has it somewhat, but it has gotten better. He has somewhat of one, because he said to her on Saturday (30Jan2021), he said he is going to go to Patient First, that he thought he had strep, his throat is sore, and she said ok. She didn't think he had it thought it was that coughing irritated his throat (she played doctor) but he said no, he was going to go to make sure he had no strep. She agreed so he went to a facility there, but they wouldn't allow him in the door because he said he thought he had strep, but they said he couldn't get treated there so they sent him home. They said he didn't have it, he thought he did, he was given a test (unknown results), they said he didn't have it, and he woke up this morning, it's like when you get up in morning, but it has subsided. He doesn't have strep; he went to the facility to see if they could tell him. She also reported that they are both so fatigued and so tired. She mentioned that her husband's second dose is scheduled for 20Feb2021. She inquired if this was after the first dose, what's going to happen after the second dose. She wanted to know if she and her husband can take the second dose, scheduled on 17Feb2021. The outcome of the event chills was recovered on an unspecified date in 2021, as for the events fever, fatigue and feeling unwell were unknown while the outcome of the other events was recovering. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021144915 same reporter/drug, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Cough', 'Fatigue', 'Headache', 'Laboratory test', 'Malaise', 'Oropharyngeal pain', 'Pharyngitis streptococcal', 'Pyrexia']",1,PFIZER\BIONTECH, 1073498,,91.0,M,"back and neck pain/ back was hurting and went up into his neck; back and neck pain/ back was hurting and went up into his neck; feeling ""woozy/dizzy""/ lightheaded; This is a spontaneous report from a contactable consumer (patient's daughter). A 91-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter said that her father received his 1st dose of vaccine on 25Jan2021. Yesterday on 01Feb2021, patient started experiencing back and neck pain and feeling ""woozy/dizzy"". She also reported that patient's back was hurting and went up into his neck. Reporter said that he is really dizzy, that's what he's concerned about. And today on 02Feb2021, he was feeling lightheaded and dizzy. Reporter asking if these could be side effects from the vaccine since its a week later. She also would like to know if he should get the second shot. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,02/01/2021,7.0,UNK,,,,,,"['Back pain', 'Dizziness', 'Neck pain']",1,PFIZER\BIONTECH, 1073499,OH,,F,"lump in her left arm, where she received the injection; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 01Feb2021 at a single dose for COVID-19 immunization. Medical history included ongoing arthritis. Concomitant medication included diphenhydramine hydrochloride, paracetamol (TYLENOL PM) for arthritis to help her sleep. The patient reported a ""lump in her left arm, where she received the injection"" on 01Feb2021. She asked if she could take diphenhydramine hydrochloride, paracetamol after her first and/or her second dose of the vaccine, how long to wait after the injection to take it and she mentioned she sometimes takes it at night to sleep better because she has arthritis. The patient further stated she was holding for drug safety and got disconnected. Stated she took diphenhydramine hydrochloride, paracetamol right after her first shot. She stated she got the Covid vaccine yesterday, stated everyone was telling her that she cannot take diphenhydramine hydrochloride, paracetamol. She clarified that she takes diphenhydramine hydrochloride, paracetamol once and a while for arthritis to help her sleep, wanted to know if this was true or not. The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,TYLENOL PM,Arthritis,,,,['Vaccination site mass'],1,PFIZER\BIONTECH, 1073500,MI,72.0,M,"first thought it was a rash, and after he went to the Dr., she confirmed that what he had was actually the shingles; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL1283), via an unspecified route of administration on 15Jan2021 17:00 (at 72-year-old) at single dose (Left Arm) for COVID-19 immunization. Medical history included type 2 diabetes (he uses insulin for this), bladder cancer (he was a former bladder cancer patient). Concomitant medication included insulin for Type 2 diabetes. Patient had the first dose of the Pfizer BioNTech COVID-19 vaccine. A week later, he had developed a rash and it turned into shingles. It is currently clearing up and he is taking medications for it. He is due for his second shot of the vaccine on 05Feb2021 and was wondering if there are any recommendations for him not to take it. It was clarified that on 22Jan2021 a rash developed on his face which was found to be shingles. He saw a personal doctor, the doctor even put him on medication. All has gone well, once he started taking the medication the shingles didn't progress and dried up and is now in the late stage of drying up. He asked if he should be reporting this, he also would like to know if he should get the second covid vaccine. The Rash started on 22Jan2021 and was on the face, hair scalp region. He specified further that the rash was located in the upper right quadrant on his face, also being on the eye lid and hairline. He added that he actually had a second doctor check this as well, because the rash was on the eyelid. His Primary Care doctor had him see a ophthalmologist. Patient clarified that he first thought it was a rash, and after he went to the Dr., she confirmed that what he had was actually the shingles. Outcome described as still with a little bit of redness, but it is healing and it is dried up. Dr prescribed him Valtrex for the shingles. The patient underwent lab tests and procedures which included that he has had no positive covid tests. In Dec2020, he had the regular covid test and that was negative. In early Jan2021, he had the regular covid test as well as a covid-19 antibody test, and both were negative. Patient mentioned serology test, he then confirmed that he used the word serology inadvertently, and meant antibody. He has had no issues with vaccines in the past. The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/22/2021,7.0,UNK,INSULIN,,Medical History/Concurrent Conditions: Bladder cancer (He was a former bladder cancer patient); Type 2 diabetes mellitus (He uses insulin for this),,,"['Herpes zoster', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1073501,MS,57.0,M,"tested positive for COVID as well/started to feel real sick; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN9581), via an unspecified route of administration (injection) into left arm on 27Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD), he has chronic bronchitis and was diagnosed with COPD probably over a year ago and stated that he takes inhalers, but no further details were provided by the caller, ongoing prediabetes diagnosed about two to three years ago, ongoing high blood pressure from 2008 and he stated that he takes 95 mg of three different types of blood pressure medications; but no further details on medication names or exact dosing of each were provided by the caller, and ongoing high cholesterol from 2008. Concomitant medication included metformin for prediabetes, started the product about two to three years ago and ongoing. The patient would like to know if he may take the second dose of the COVID vaccine after testing positive for COVID. He stated that he received the 1st dose of the COVID vaccine on 27Jan2021, started to feel real sick on 31Jan2021 and tested positive for COVID. It was further reported that he got his first shot of the COVID vaccine on Wednesday last week. On Friday, he stated that his wife tested positive for COVID, and then the caller got real sick on Sunday, and he then tested positive for COVID as well. He was wondering if that will affect the second dose or if there were recommendations about the second dose for people who got COVID in between doses. He stated that he has breathing problems anyway. He was planning to call yesterday but he still was not feeling up to it yesterday. He was starting to come over the hill today though. He reported that he just went online and scheduled the appointment himself for the vaccine because he has COPD, and they were allowing people with underlying issues to get the vaccine. He provided his primary care information as they were the ones who tested him for COVID on Sunday. He reported that he got his COVID vaccine on 27Jan2021, and he was tested for COVID on Sunday 31Jan2021. He stated that the clinic told him that the test takes about 15 minutes but they came back in about 10 minutes and told him that he was positive for COVID. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/31/2021,4.0,UNK,METFORMIN,Blood pressure high (he takes 95mg of three different types of blood pressure medications;); COPD (he has chronic bronchitis and was diagnosed with COPD probably over a year ago); High cholesterol; Prediabetes (diagnosed about two to three years ago),Medical History/Concurrent Conditions: Chronic bronchitis,,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1073502,IN,85.0,F,"sore arm; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received first dose of BNT162B2, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient asked if she can get the second dose of the Pfizer covid-19 vaccine while taking tofacitinib citrate (XELJANZ). She forgot to ask for the first dose and she already got it. She received the first dose of the Pfizer covid-19 vaccine and experiencing a sore arm that lasted a couple of days. The patient recovered from sore arm on an unspecified date. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1073503,,,M,"exhausted; like catching a cold; fluid pouring out of his nose; eyes was tearing and eye lid blew up; eyes was tearing and eye lid blew up; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the right arm, on 23Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient felt exhausted and like catching a cold and had fluid pouring out of his nose. His eyes was tearing and eye lid blew up on 2021. Everything happened on his right side and it lasted 4 days. He was told to take allergic medication. Outcome of the events was unknown Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,,,UNK,,,,,,"['Fatigue', 'Lacrimation increased', 'Nasopharyngitis', 'Rhinorrhoea', 'Swelling of eyelid']",UNK,PFIZER\BIONTECH, 1073504,NC,67.0,F,"low grade fever (99.4F); really bad headache with aches all over/aching all over; feeling like she had been run over by a truck; really bad headache with aches all over/head has been hurting really bad; cough; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received her first dose bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262; expiration date: unknown) at vaccination age of 67-year-old via an unspecified route of administration in the left arm on 29Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included blood pressure (blood pressure abnormal), cholesterol (blood cholesterol) and several bypass surgeries. She mentioned that she was pretty healthy for her age. Family history included father died of heart disease and her sister has heart disease. Concomitant medication included unspecified blood pressure and cholesterol medication. The patient has no previous vaccination within 4 weeks and did have other vaccines given on the same day. The patient reported that she did not feel bad on the first day, but she started getting a cough on Saturday night (30Jan2021) and on Sunday (31Jan2021), she started getting a really bad headache with aches all over. This morning (02Feb2021), she is running a low-grade fever (99.4F). She added that now she was sick, she has a low-grade fever, chills, is hurting all over, all the things on the list. She inquired if these are common side effects of the vaccine and was asking if she should get tested to see if she's diagnosed with COVID-19. She inquired will her getting the shot effect the results of the COVID test, would she test positive for COVID now that she's had the shot. It is confirmed she has not tested positive for COVID. She did have 2 tests previously in Dec2020 before and after traveling. She further explained that she didn't feel bad until Saturday night and that is when she started with nagging cough. The aching all over started on Sunday (31Jan2021), feeling like she had been run over by a truck. She hadn't had a fever until this morning (02Feb2021), she woke up with a low-grade temperature of 99.4. She has been taking acetaminophen (TYLENOL) that helps. The call also notes later in the call that her head has been hurting really bad and this started yesterday (01Feb2021 [also reported as 31Jan2021]). It is remarked that she will probably be tested if the vaccine doesn't affect the results. The adverse events did not require emergency room or physician office. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure abnormal; Bypass surgery; Cholesterol; Family history of cardiovascular disorder (father died of heart disease and her sister has heart disease),,,"['Body temperature', 'Cough', 'Feeling abnormal', 'Headache', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1073505,WI,77.0,F,"Hives; itching throughout her body; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982), intramuscular on the left arm at the age of 77 years, on 27Jan2021 11:30 at a SINGLE DOSE for covid-19 immunization and cefuroxime axetil (CEFUROXIME AXETIL), oral from 25Jan2021 to Jan2021 at 250 mg, 2x/day (250mg tablet, one tablet twice a day by mouth ) for urinary tract infection. Medical history included ongoing diabetes mellitus diagnosed many years ago, ongoing rash because she was still having a problem in her pubic area with a rash that is going on, states this is from the urinary tract infection and urinary tract infection from an unknown date and unknown if ongoing. When she got the vaccine she was on an antibiotic for a urinary tract infection (UTI), she is asking if there would be any correlation or any interaction between the antibiotic and the vaccine. The antibiotic was something she has taken quite often and has taken it before called cefuroxime axetil. Concomitant medication included insulin (INSULIN) for diabetes. The patient developed itching throughout her body, like hives that started late Friday (29Jan2021) and she will get areas on her hands and arms. This morning it was on her legs where it was red and warm. She reported it goes away and comes back. This morning the hives were fairly heavy and now that she has gotten up and cooled her body down, the hives were subsiding. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/29/2021,4.0,OTH,INSULIN; CEFUROXIME AXETIL,"Diabetes (diagnosed many years ago); Rash (She is still having a problem in her pubic area with a rash that is going on, states this is from the urinary tract infection.)","Medical History/Concurrent Conditions: Urinary tract infection (When she got the vaccine she was on an antibiotic for a urinary tract infection (UTI), she is asking if there would be any correlation or any interaction between the antibiotic and the vaccine. The antibiotic is something she has taken quite often and has taken it before called cefuroxime axetil)",,,"['Pruritus', 'Urticaria']",1,PFIZER\BIONTECH,OT 1073506,,,F,"diagnosed with covid 19; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient got on 22Jan2021 the first dose of the vaccine and she was scheduled to get the second on 12Feb2021 but she got diagnosed with Covid 19 on 2021. She would like to know if she should receive the second dose. Outcome of the event was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,,,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 1073507,,,F,"swelling of the face and itching all over her body; swelling of her face and eyes; itching all over her body; it is worse with swelling of her face and eyes and itching and rashes; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age (reported as ""Age:70; Unit: Unknown) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that his wife had no problem after the first dose of the vaccine on an unspecified date. After the second dose, patient had swelling of the face and itching all over her body. Reporter stated the first two days were okay, but the third day patient went to emergency room and got Cortisol. On ""Sunday"", patient was better and now it was worse with swelling of her face and eyes and itching and rashes. Outcome of the events was not recovered. No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Eye swelling', 'Pruritus', 'Rash', 'Swelling face']",2,PFIZER\BIONTECH, 1073508,MD,78.0,F,"headache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EN5318), via an unspecified route of administration at the left arm on 29Jan2021 at single dose for covid-19 immunization. She doesn't really have any other health problems or take many medications. On 31Jan2021, the patient experienced headache. They are not just little small headaches. She has taken Tylenol/ Acetaminophen for it. She will get more. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/31/2021,2.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Headache'],1,PFIZER\BIONTECH, 1073509,,,M,"tiredness/tired; weakness/weak; headache; This is a spontaneous report from a contactable consumer. A male patient (husband) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient is due to receive his second dose of Pfizer-BioNTech Covid19 vaccine this Friday, 05Feb2021. After the first dose on an unspecified date, the patient experienced, tiredness/tired, weakness/weak, and a headache. The reporter wanted to know if they should push back the interval to 4 weeks, to alleviate adverse events after the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Asthenia', 'Fatigue', 'Headache']",1,PFIZER\BIONTECH, 1073510,,,M,"face turned puffy; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter was asking if the second dose of the vaccine should be taken if you experienced a reaction after the first dose. It was reported that the patient's face turned puffy on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Swelling face'],1,PFIZER\BIONTECH, 1073511,,32.0,M,"shingles rash; pain; This is a spontaneous report from a contactable healthcare professional via a Pfizer-sponsored program. A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on an unspecified date. The patient developed shingles after the second dose of the Pfizer covid 19 vaccine. He received the vaccine on 29Jan2021 and developed a shingles rash on Sunday (31Jan2021). The healthcare professional wanted to know if he can take antivirals, if it is safe for him to get antivirals, and what he could take for pain on an unspecified date in 2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/31/2021,2.0,UNK,,,,,,"['Herpes zoster', 'Pain']",2,PFIZER\BIONTECH, 1073512,CT,62.0,M,"diarrhea; whole body aches; He can't sleep; feels like crap; This is a spontaneous report from a contactable consumer. A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EL9264 expiry date not reported) via an unspecified route of administration from 31Jan2021 at single dose for covid-19 immunization. The patient's medical history includes ongoing nausea and Not able to eat/ he can't drink or eat. Just thinking about eating makes him nauseated and threw up. Concomitant medications were not reported. The patient experienced whole body aches, he can't sleep and feels like crap on 31Jan2021. The patient also experienced diarrhea on 02Feb2021. The patient mentioned that on the morning of the vaccine, Sunday, he woke up, and tried to drink coffee and threw up. The Sunday morning he was nauseous before the shot. When he drank his coffee that morning. In the mornings, he can't drink or eat. Just thinking about eating makes him nauseated. His body aches started a little while after the shot. It was still Sunday when they started though. He can't sleep the body aches are so bad. Sunday evening is when he started to feel like crap. He has also had diarrhea. The outcome of the events whole body aches, feels like crap and diarrhea was not recovered. Outcome of the event He can't sleep was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,01/31/2021,0.0,UNK,,Nausea; Unable to eat,Medical History/Concurrent Conditions: Vomiting,,,"['Diarrhoea', 'Feeling abnormal', 'Insomnia', 'Pain']",1,PFIZER\BIONTECH, 1073513,,,F,"a little sore arm; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported for similar events. This is the first of the two reports. A female patient of an unspecified age received the first dose bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 22Dec2020 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a little sore arm on an unspecified date. The outcome of event was unknown. The information on the lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021149307 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/22/2020,,,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1073514,,,F,"Felt bad with a headcahe which kept getting worse; Fever that never got over 102F; Rash; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On a unspecified date, it was reported that the first 2-3 days the patient felt bad with a headache which kept getting worse, fever that never got over 102F. The headache was the worst which lasted 10 days or longer. This continued for about a week. The patient also had a rash which eventually disappeared, nausea & vomiting. The patient's doctor is not sure whether or not to continue with the second dose. Seeking guidance given the side effects experienced. The patient was tested for COVID-19 and the results were negative on an unspecified date. The outcome of the event rash was recovered while for the rest of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,,,UNK,,,,,,"['Body temperature', 'Headache', 'Nausea', 'Pyrexia', 'Rash', 'SARS-CoV-2 test', 'Vomiting']",1,PFIZER\BIONTECH, 1073515,FL,74.0,F,"heart palpitations/ palpitations; patient decided on her own to take Levoxyl sublingually / started taking a little more/ started increasing the thyroid medication; This is a spontaneous report from a contactable consumer (patient) received via the Medical Information Team and the Pfizer-sponsored Program. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/ batch number: EL1283 and expiry date unknown), via an unspecified route of administration on 20Jan2021 (at 74 years old) at a SINGLE DOSE for COVID-19 immunization, ""for fun, for fear""; and levothyroxine sodium (LEVOXYL Tablet), orally from 12Nov2020 to an unspecified date and sublingually at the beginning of Jan2021 (also reported as 20Jan2021) to an unspecified date at 0.25 mg, daily (she would take half of the tablet in the morning and half at night) for hypothyroidism. The patient's medical history included hypothryroidism from an unknown date. Patient's height used to be five foot three with weight: between 140 to 150 pounds, usually around 145 pounds. Concomitant medications included Magnesium Malate at 1000mg and at 200mg (lot number: X002OISTE1 and expiration date: Aug2023). She got Magnesium the heart doctor told her to get. She stopped taking it on 22Jan2021, two days after the first episode on the 20Jan2021. Patient previously had problems with another thyroid drug, it was a natural thyroid medication called NP THYROID and she had palpitations on that one. The drug was not as standardized because it is natural thyroid. She started it in 2019 and took for a year and half. She was on a higher dose, 30mg originally and dropped down to 15mg or .25gram because it was ""too much."" The pharmacy sent a notice out that a dosage was too high in May or Jun. Then in Sep the dosage was too low. She asked pharmacy about the lot number and they said they didn't put it on there. She got it from (Pharmacy name withheld). RX number: 1677890-07298. Manufacturer: (Company name withheld). The dose amount had dropped, and she wasn't getting enough of the drug and her TSH had gone very high. That was causing the palpitations. Then she was switched to levothyroxine sodium. On 20Jan2021, patient experienced heart palpitations. It was reported that at the beginning of Jan2021 (also reported as 20Jan2021), patient decided on her own to take levothyroxine sodium sublingually and she experienced heart palpitations. Patient confirmed that this was not prescribed to be taken sublingually. Patient asked if taking levothyroxine sodium sublingually increase its potency. Also, on 20Jan2021, she received the first dose of the Pfizer Covid vaccine. Her thyroid levels taken this past Friday (29Jan2021) were normal. Patient asked if taking the Covid vaccine with levothyroxine sodium cause palpitations. She wanted to know if there is data on taking levothyroxine sodium sublingually. She wanted to know if it has more of an effect and wondered if taking levothyroxine sodium sublingually might have effected it. She doubts if Pfizer has studied it sublingually, but would that have increased the potency of the levothyroxine sodium? Maybe she got more than she was getting before. On 20Jan2021 she received Pfizer's COVID19 Vaccine. She started having palpitations that night and she was not sure if the vaccine had anything to do with it. The palpitations are ongoing. Some days they get worse and other days they are ok. She thought she was low on levothyroxine sodium, so she started taking a little more. She knew she was supposed to call the doctor. The day after she got palpitations, she started increasing the thyroid medication and it didn't seem to help. Over- the- counter Zinc, Magnesium, and Potassium helped. Zinc seemed to have most effect at trying to reduce them. It was reported that patient took Zinc 30 Orotate (lot number: 210606, expiration date: Nov2020). She took it on three occasions when she had it bad. Within a few hours after she took it the palpitations calmed down. Patient also took Potassium (lot number: 8BO3217 and expiration: Mar2003). She has only taken it twice since the palpitations. She doesn't take those normally except for the Magnesium. She went to the doctor yesterday, but she didn't see the doctor and only saw the nurse. She underwent thyroid test on Friday, 29Jan2021 and it was within range. The TSH was not high, meaning she was getting the correct amount. She doesn't know how quickly taking the half thyroid pill would have effected it at that point. Supposedly she is within range, but still was having palpitations. Some days are really bad and other days not so bad. The levothyroxine sodium is the same prescription bottle. She just switched from taking it orally to sublingual. She took it orally for the first several months and then switched to sublingual, for both, she would take half of the tablet in the morning and half at night because she was so reactive to medication. She was concerned if she should get the second dose of COVID-19 vaccine because ""you never know."" The patient further reported that she saw the cardiologist in the fall, and he did EKG and didn't find anything unusual. She is going to go see him again tomorrow because her other doctor said if the heart palpitations are bad enough, she needs to go to the ER and get EKG. She just had EKG in the fall. She knows it was a reaction to something. As soon as she started getting more thyroid medication in her, it went away. The action taken in response to the event for levothyroxine sodium was unknown and for BNT162B2 was not applicable. Outcome of the event heart palpitations/ palpitations was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,11/12/2020,01/01/2021,50.0,UNK,MAGNESIUM MALATE; LEVOXYL,,Medical History/Concurrent Conditions: Hypothyroidism,,,"['Blood thyroid stimulating hormone', 'Body height', 'Electrocardiogram', 'Intentional product misuse', 'Palpitations', 'Thyroid function test', 'Weight']",1,PFIZER\BIONTECH, 1073516,SC,73.0,F,"food poisoning; First got really sick; nausea/She got sick to her stomach; head colds/feels like coming down with a cold; Feeling unwell/she wasn't feeling well; Dry heaved for 40 minutes. Saliva in her stomach was coming up, not food. Felt like it lasted forever.; sinus problems.; vomiting; Pain injection site; Slight headache; Chills, feels like coming down with a cold; Tired; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: RL3249), via an unspecified route of administration at left arm on 26Jan2021 14:00 (also reported as 17Jan2021 - pending clarification) at SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks. Medical history included diabetes, cancer (prior to receiving COVID-19 shot. Stated she was 14 years cancer free), allergy, shingles shot which hurt at the injection site, shrinks every year (Doesn't know exact number, but a little under 5 feet). The patient had no family medical history. Concomitant medication included mometasone furoate (FLONASE [MOMETASONE FUROATE]). On an unspecified date, the patient experienced she got sick to her stomach, food poisoning, ""nausea/She got sick to her stomach,"" ""head colds/feels like coming down with a cold,"" ""feeling unwell/she wasn't feeling well,"" ""dry heaved for 40 minutes. Saliva in her stomach was coming up, not food. Felt like it lasted forever,"" sinus problems, vomiting, and first got really sick. On 26Jan2021, the patient experienced tired, slight headache, chills feels like coming down with a cold, and pain injection site. The patient reported that she received the first dose of the Pfizer vaccine and experienced side effects including nausea, head colds, and sinus problems. She was concerned that this may be covid and if it will be safe for her to get the second dose of the vaccine as scheduled. The patient further reported that she first got really sick. Never had the flu and always gets head colds or food poisoning on an unspecified date. After reading material passed out, perhaps she was treating COVID and not a cold or allergy. The patient took first COVID-19 shot on 26Jan2021. Thought everything was fine. The patient was close to bedtime then noticed she wasn't feeling well. Looked at side effects and has like six of them at the same time. Right as she was going to rest, she got sick to her stomach. Never was sick to her stomach except when she was food poisoned. The patient had dry heaved for 40 minutes. Saliva in her stomach was coming up, not food. Felt like it lasted forever on an unspecified date. The patient asked that if she does have COVID, should she take the second shot? Wanted to get tested because Pfizer materials says exactly what her headache and sinus stuff was about. Now she was scared. The patient also reported that she wanted to take the second COVID-19 shot. If she does have COVID, thinks it's not the thing to do right now. It was confirmed she has not had a positive COVID test after receiving the first COVID-19 shot. Should have read material prior to and maybe wouldn't have taken the first COVID-19 shot. Confirmed symptoms she mentioned occurred after the COVID-19 shot. The patient came home from COVID-19 shot feeling fine. Didn't get sick until close to bedtime. Appointment for COVID-19 shot was 2:30PM. Clarified six symptoms previously mentioned: The patient had pain at injection site just two days and was gone. Began shortly after she got home from the COVID-19 shot. Went to lift arm up and it didn't feel good. Began an hour or two after COVID-19 shot. The patient was tired unusually early in the day. Felt like she didn't want to do anything. Couldn't use her left arm. Clarified left arm was injection arm. Tiredness has subsided and only lasted a couple of days. It was further reported that patient never gets headaches. It started after vomiting which didn't last long. It bothered her and then was gone by the time she went to sleep. The patient had chills, feels like coming down with a cold on an unspecified date which subsided right before dinner around 3PM-4PM. The patient had to put on a fluffy robe to keep warm. It was also reported that the patient did not have a fever. It was also reported that shingles shot hurt at injection site where pain lasted a week and a half. Temperature went from 98.6 degrees to 99 degrees. The patient was taking stuff now and monitoring to see if she can see any signs. The patient was feeling unwell on an unspecified date which has subsided except for allergies and she was concerned. The patient also experienced dry heaving: didn't have anything in her stomach on an unspecified date which subsided. Even after she ate yesterday, hasn't had any dry heaving except for night of the COVID-19 shot. The patient underwent lab tests and procedure which included body height: little under 5 feet (doesn't know exact number), temperature: went from 98.6 degrees to 99 degrees, and COVID test: negative (she has not had a positive COVID test after receiving the first COVID-19 shot). Therapeutic measures were taken as a result of sinus disorder which included sinus medication and was squirting Flonase in her nose. On an unspecified date, the patient recovered from slight headache. The patient had not yet recovered from the event nausea and vomiting. The outcome of the events chills, tired, food poisoning, first got really sick, head colds/feels like coming down with a cold, feeling unwell/she wasn't feeling well, dry heaves, sinus problems, and pain injection site were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,OTH,FLONASE [MOMETASONE FUROATE],,Medical History/Concurrent Conditions: Allergy; Body height decreased (but a little under 5 feet); Cancer (prior to receiving COVID-19 shot. Stated she was 14 years cancer free); Diabetes; Shingles (Shingles shot hurt at injection site. Pain lasted a week and a half.),,,"['Body height', 'Body temperature', 'Chills', 'Fatigue', 'Food poisoning', 'Headache', 'Illness', 'Malaise', 'Nasopharyngitis', 'Nausea', 'Retching', 'SARS-CoV-2 test', 'Sinus disorder', 'Vaccination site pain', 'Vomiting']",1,PFIZER\BIONTECH, 1073517,AZ,85.0,F,"dizzy; stomach seems a little upset; didn't sleep very well; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient started received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264 and expiry date: unknown), via an unspecified route of administration on the right arm, on 01Feb2021 at a single dose for COVID-19 immunization. The first dose was received on 11Jan2021 (lot number: EL0142) Medical history included GERD. Concomitant medication included pantoprazole and other unspecified product. Patient got the first shot of the COVID vaccine three weeks ago, and she didn't know anything had happened to her. She got the second dose of the vaccine yesterday at noon, and she was fine, although she didn't sleep very well on 01Feb2021. But the morning of 02Feb2020, she went in the kitchen and dropped some blueberries because the plastic boxes don't close easily, and she bent over to pick the blueberries up and she got dizzy. She did not know why she should get suddenly dizzy, and her stomach seemed a little upset, but she has no fever on 02Feb2021. Patient was just wondering if the dizziness is a side effect of the vaccine. Patient had no other vaccines on the same day as the COVID vaccine and stated when she had the incident where she bent over and was dizzy, it felt just really terrible, but she was feeling fine now, but the incident did shake her up a bit. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,PANTOPRAZOLE,,Medical History/Concurrent Conditions: GERD,,,"['Abdominal discomfort', 'Dizziness', 'Poor quality sleep']",UNK,PFIZER\BIONTECH, 1073519,,,F,"stiff neck; crampy on both sides of her neck; This is a spontaneous report from a contactable consumer (patient's husband) via Medical Information Team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 29Jan2021 at SINGLE DOSE for COVID-19 Immunisation. The patient's medical history and concomitant medications were not reported. The patient got the vaccine on Friday (29Jan2021) and then on Sunday (31Jan2021) she started having a stiff neck. She can barely move her head side to side. The reporter further stated that the patient has stiff neck type things, and was crampy on both sides of her neck and can hardly turn it sideways, up or down. He would like to know if this may be caused by the vaccine. The outcome of all the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/31/2021,2.0,UNK,,,,,,"['Muscle spasms', 'Musculoskeletal stiffness']",UNK,PFIZER\BIONTECH, 1073520,FL,,M,"he has back problems; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included colon cancer and melanomas taken out of his neck and ear, but he didn't receive chemotherapy. Concomitant medications were not reported. The patient had back problems on an unspecified date. On an unspecified date, the patient underwent lab tests and procedures which included computerised tomogram and x-ray, both with unknown results. Clinical outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Colon cancer; Melanoma,,,"['Back disorder', 'Computerised tomogram', 'X-ray']",1,PFIZER\BIONTECH, 1073521,MA,74.0,F,"Had the runs (diarrhea); Felt numbness in my cheek; Getting nauseous; Not feeling good. Cant do too much of anything, just sit/ sick; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient (also age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9269), intramuscular from 30Jan2021 17:00 (5pm) in the left arm at SINGLE DOSE for covid-19 immunization. The patient was vaccinated at a Pharmacy (Pharmacy/drug store). Medical history included ongoing thyroid condition diagnosed at least 10 years ago. Concomitant medication included levothyroxine (LEVOTHYROXINE) at 50mcg tablet once a day by mouth (Taking it for years) for Thyroid/ thyroid condition. For prior vaccinations: The higher dose, senior dose of the flu shot (for immunization), she stopped taking it when the lower dose came out. She gets very sick with the senior dose. She does not know the name and does not have lot number of the senior dose of the flu shot to provide. It was stated to the patient that there may be too much protein in it. The patient is asking if she should get 2nd dose after having negative experience post vaccination of 1st dose. The patient received first dose of vaccine on sat (30Jan2021) evening. It was reported that as soon as she got to her car, ""I thought I felt numbness in my cheek. It didn't stay, went right away. My husband thought i was just nervous. It was also stated that she then started ""getting nauseous"" about 30min after vaccine. The patient has ""been sick since I had it.. not sure if its normal? It was also reported that she ""had the runs"" (diarrhea) for one day, that has now resulted. It was also said that ""I'm not feeling good. cant do too much of anything, just sit"". The patient asked if this is normal and ""when will I feel better""? It was also reported as she had the first dose of the Pfizer covid vaccine late Saturday afternoon at 5pm. She has been feeling nausea and sick since then. She asks if this is normal and how long it will stay. The treatment used was taking Tylenol. It was noted that if she does not do anything and lays down it will go away but if she starts doing too much she will get real nauseous again. It was added that the patient and her husband went to get the vaccine on the same day. It was noted that she felt a little numbness on her face, in her right cheek and then it went away after 20 to 30 seconds. Her husband said she may have been nervous and may have caused that herself. She is a hyper type. The outcome of the event Felt numbness in my cheek recovered on 30Jan2021; for all other events was unknown. There was no additional vaccines administered on same date. No events requires visit to emergency room or physician office. No prior vaccinations (within 4 weeks) reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/30/2021,0.0,PHM,LEVOTHYROXINE,Thyroid disorder (diagnosed at least 10 years ago),,,,"['Diarrhoea', 'Hypoaesthesia', 'Malaise', 'Nausea']",1,PFIZER\BIONTECH,OT 1073522,GA,41.0,M,"cough; runny nose; fuzzy headed/scatter brained; not sleeping good; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: WEN5318), via an unspecified route of administration on left arm on 28Jan2021 (at the age of 41years) at single dose for covid-19 immunization. Medical history included scratchy throat the day before the vaccine (27Jan2021). The patient had no concomitant medications and no investigation assessment. The patient got first dose of vaccine 28Jan2021 and was debating whether to get Covid test because of symptoms. The patient had a cough and runny nose on 29Jan2021 and fuzzy headed, scatter brained and not sleeping good in 2021. The patient considered the events as non-serious. Asked if these symptoms were from the vaccine and if getting the vaccine cause a false positive on the Covid test. Stated Friday had cough and runny nose. He stated that it felt like he had a pretty bad head cold and would not think about getting tested but since Covid was around. Wanted to know if these were common side effects of the vaccine or if he needed to get tested. The patient just moved houses and it was a stressful process. Sometimes when one gets stressed that one gets sick and may have contributed to his condition. Later clarified that this was for the Pfizer Covid 19 vaccine. The patient stated that the cough and runny nose worsened over the weekend and was a little better now and took alpha lipoic acid;minerals nos;quercetrin;vitamins nos (EMERGEN-C). The outcome of the events cough and rhinorrhea was recovering while unknown for the remaining events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Throat irritation (the day before the vaccine),,,"['Cough', 'Feeling abnormal', 'Insomnia', 'Rhinorrhoea']",1,PFIZER\BIONTECH, 1073523,,,F,"1 tiny red blister on her mother's abdomen/she had a couple of blisters in her torso, feet, and especially on her hands; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, the nurse noticed one tiny red blister on her mother's abdomen. In the morning of 02Feb2021, she had a couple of blisters on her torso, feet, and especially on her hands. The nurse said her mother's blisters are tender to touch, and she wanted to know if there had been reports of blisters from the Pfizer vaccine and she would like some information she could take with her for her mother's doctor's appointment on 03Feb2021. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/26/2021,1.0,UNK,,,,,,['Blister'],2,PFIZER\BIONTECH, 1073524,MI,,F,"headache; This is a spontaneous report from a contactable physician (patient). An adult female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received the first dose and almost immediately experienced head, ears and headache (as reported). She followed up with her health care provider and wanted her to take Medrol dose pack and ibuprofen. The patient was looking for the duration and reporting information following each dose, specifically headaches. The patient asked for contraindications or recommendations for the second dose. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/21/2021,0.0,UNK,,,,,,['Headache'],1,PFIZER\BIONTECH, 1073525,NC,78.0,F,"rash upper arms; Itching; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration on the left arm, at the age of 78 years, on 20Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included diabetes mellitus from 1980 to an unknown date and rheumatoid arthritis from 1980 to an unknown date. The patient's concomitant medications included an unspecified flu shot in Nov2020. The patient experienced some rash in the upper arm and itching on 20Jan2021 which has gotten better (she added that she did not take anything medical for this, just a night cream). She added that she was allergic to epinephrine which she mentioned during her first shot. She was asking if it was okay to proceed with the second dose. The patient said that she got the first dose injected on January 20th to her left arm, and that evening she had the rash. She says she didn't really treat the rash, she just used cream for the itching. She says the rash was that she broke out on the upper part of both of her arms. She says that the itching did get better. Therapeutic measures were taken as a result of itching (pruritus). The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/20/2021,0.0,UNK,,,"Medical History/Concurrent Conditions: Diabetic (Additional Information for Other Conditions: Caller says this was diagnosed when she was 55, in 1980 something.); Rheumatoid arthritis (Additional Information for Other Conditions: Caller says this was diagnosed when she was 56, in 1980 something.)",,,"['Pruritus', 'Rash']",1,PFIZER\BIONTECH, 1073526,,,M,"He is sick; feels bad; This is a spontaneous report from a contactable consumer (patient himself). A male patient of unspecified age (reported as 'Age: 78; Units: Unknown') received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced stated ""he is sick and will not be able to make it today."" He asked how can he get in touch with them to cancel the appointment. He stated he did not report his symptoms because he feels bad so much of the time, he has so many days that he feels bad that it wouldn't give them much help because he doesn't think it is from the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. A causal association between BNT162B2 and the reported events cannot be completely excluded based on the information provided. Case will be re-assess once additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Feeling abnormal', 'Malaise']",1,PFIZER\BIONTECH, 1073527,FL,,M,"He still has some ringing in the ear and heaviness around the head; He still has some ringing in the ear and heaviness around the head; If he hears the slightest noise it is louder than normal; This is a spontaneous report from a contactable consumer (reporting for himself) via the medical information team. A male patient of an unspecified age received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 (reported as a month ago) to Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated that he still has some ringing in the ear and heaviness around the head. He consulted his doctor and his conclusion after the assessment was that it did not seem to be related to vertigo. The patient stated that if he hears the slightest noise it was louder than normal. The outcome of the event tinnitus and head discomfort was not recovered while unknown for the other event. Information on the Batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,,,UNK,,,,,,"['Head discomfort', 'Hypoacusis', 'Tinnitus']",2,PFIZER\BIONTECH, 1073528,TX,51.0,M,"Dizziness/felt woozy/light headed; Weakness; vision changed; increased heart rate/heart rate went up slightly; had pressure in his head; pressure in his hands and feet like he could not move his feet; pressure in his hands and feet like he could not move his feet; headache; muscle tightness/muscles tightened in his back and in his calf muscles/tightness in his neck; he felt like he was just not himself; lethargic; lump in his throat; lymph nodes got tight on the same side as the vaccine/lymph node on his left side was tight throughout his neck; cringing in his stomach muscles; kind of like a muscle spasm in his stomach; didn't sleep that well last night; wobbly; back was hurting; muscle pain; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EZ9261, expiry date: unknown), via an unspecified route of administration, from 01Feb2021, at single dose, for COVID-19 immunization. Medical history included anemia (anemic), inflammation, acid reflux (esophageal), pain, on blood thinner, high cholesterol, sinus disorder (sinuses), overactive bladder/bladder control, acid reflux, stools hard (to soften stool), nerves, blood pressure high (high bp), car accident, and costochondritis in chest. Concomitant medication included atorvastatin calcium for high cholesterol from an unspecified date and ongoing; docusate sodium to soften stool; famotidine to soften stool from an unspecified date and ongoing; garlic [allium sativum] as blood thinner from Nov2020 (3 months ago) and ongoing, gabapentin for nerves from an unspecified date to an unspecified date and from Nov2020 (got back on this 3 months ago) and ongoing; hydrocodone for pain; iron for anemia from Nov2020 (been taking this for the last 3 months) and ongoing; meloxicam for inflammation, omeprazole (PROTONIX) for acid reflux from an unspecified date and ongoing; tadalafil for overactive bladder/bladder control from an unspecified date and ongoing; vitamin c (ascorbic acid), colecalciferol (VITAMIN D), vitamin b for trying to build up his immune system; ranitidine hydrochloride (ZANTAC) for sinuses; ""One a Day Men's"" from 2016 and ""50+"" (as reported, pending clarification). On 01Feb2021, after the shot, the patient experienced dizziness/felt dizzy and had weakness. When he walked to the desk to check out he felt his vision changed and his heart rate went up slightly but it did go down once he sat down but he felt woozy and had pressure in his head and pressure in his hands and feet like he could not move his feet. He was kind of like dizzy and light headed. He walked somewhere to sit down, he stayed 30 minutes and left after and sat 30 minutes in the car and he got a headache and his muscles tightened in his back and in his calf muscles and he felt like he was just not himself. He felt lethargic and felt like his lymph node on his left side was tight throughout his neck. He felt like his lymph node was getting tight and he just sat until he felt like his symptoms had dissipated. He also had lump on his throat. He had stuff going on with his stomach like cringing in his stomach muscles, it was kind of like a muscle spasm in his stomach. He didn't sleep that well last night (01Feb2021) as he felt some symptoms come on again, the tightness in his neck again and when he sat up, he got dizzy and wobbly, his back was hurting, his calf muscle was tight. He felt more muscle pain. He checked his blood pressure and it was good, but he just felt a little dizzy on 02Feb2021. The patient stated that all his symptoms have improved since 01Feb2021. The patient also mentioned that the girl looked really young (referring to the person who administered the vaccine), ""maybe she jacked it up, he knows it supposed to be a very little bit, maybe she put more in him than she was supposed to"". He went back to his doctor as he wants to come off of some of his medications because he is supposed to have another shot and he want to take the second shot. He wanted to stop taking all the medications around the second shot in case it was his medications that caused it. The patient asked since he had complications with the fist dose, should he still take the second dose. The patient was recovering from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,MIL,ATORVASTATIN CALCIUM; DOCUSATE SODIUM; FAMOTIDINE; GARLIC [ALLIUM SATIVUM]; GABAPENTIN; HYDROCODONE; IRON; MELOXICAM; PROTONIX [OMEPRAZOLE]; TADALAFIL; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; VITAMIN B NOS; ZANTAC,,Medical History/Concurrent Conditions: Accident; Acid reflux (esophageal); Acid reflux (oesophageal); Anemic; Anticoagulant therapy; Blood pressure high; Costochondritis; High cholesterol; Inflammation; Nerve pain; Overactive bladder; Pain; Sinus disorder; Stools hard,,,"['Abdominal pain upper', 'Asthenia', 'Back pain', 'Blood pressure measurement', 'Dizziness', 'Feeling abnormal', 'Gait disturbance', 'Head discomfort', 'Headache', 'Heart rate', 'Heart rate increased', 'Hypokinesia', 'Insomnia', 'Lethargy', 'Limb discomfort', 'Lymphadenopathy', 'Muscle tightness', 'Myalgia', 'Pharyngeal mass', 'Visual impairment']",1,PFIZER\BIONTECH, 1073529,,,F,"bluish dots like a bruise under the skin/red marks on top of hand and blue marks under skin; weird skin reaction to palms of hands; palms were real red; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot and expiry were not reported), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunization. Relevant medical history, concomitant medications and investigation assessment were not provided. The patient received her first COVID vaccine dose on 29Jan2021 and had a weird skin reaction to the palms of hands. Assuming it started a few hours after getting the vaccine (on 29Jan2021), had red marks on top of hand and blue marks under skin/bluish dots like a bruise under the skin. The patient stated, ""it looked like a viral rash like a kid would get but with a blue tint to it"". Took a hot shower and the palms were real red and after it calmed down everything was back to normal. As soon as it cooled down (her hands), within the hour everything was back to normal, it was really weird. Wanted to know if this has been reported or the first time Pfizer has heard this. The patient was concerned if she should get the second vaccine or not. The outcome of the event palmar erythema was recovered in Jan2021 while for the remaining events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,UNK,,,,,,"['Contusion', 'Palmar erythema', 'Skin reaction']",1,PFIZER\BIONTECH, 1073530,MI,,F,"cough; she couldn't lift her head; had muscle aches and pains; weakness; a splitting headache; couldn't move; chills; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 62; unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 31Jan2021 11:15 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient got the vaccine on Sunday 31Jan2021 at 11:15 and felt good all day. But the next day on 01Feb2021, she couldn't lift her head, had muscle aches and pains, weakness and a splitting headache. She couldn't move. She had chills but no fever measured by a forehead thermometer. She was feeling a bit better ton 02Feb2021 but still has chills and had a cough that was escalating. Patient was asking if she gets the second one, will she have the same reaction. Outcome of the event of chills was not recovered , for cough was unknown while for the remaining events was recovering Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,02/01/2021,1.0,UNK,,,,,,"['Asthenia', 'Body temperature', 'Chills', 'Cough', 'Headache', 'Joint range of motion decreased', 'Movement disorder', 'Myalgia']",UNK,PFIZER\BIONTECH, 1073531,CA,73.0,M,"constipation; bloating; gas; Headache; This is a spontaneous report from contactable consumers (one is reporting for himself and his wife). This consumer reported similar events for two patients. This is the first of two reports. A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL8982), intramuscular on 26Jan2021 10:20 at single dose on the left arm for COVID-19 immunization, reported as ""to prevent covid"". Vaccination facility type was medical center. Vaccine was not administered at military facility. There were no medical history and concomitant medications. No additional vaccines administered on same date of Pfizer suspect. The patient reported side effects of constipation, bloating and gas after the first dose of the Pfizer COVID-19 vaccine. No prior vaccinations within four weeks and no events prior vaccinations. This is the report for the caller himself. They looked at symptoms on the vaccine fact sheet and they did not have any of those symptoms. They received the first dose of the vaccine on 26Jan2021. The first couple of days on 27Jan2021, they had a little bit of a headache. The third day (29Jan2021), they started having constipation and bloating which was not normal for them. He has taken enough stuff which should have cleared it out. They were having a lot of gas and were very bloated. They are asking if anyone else has reported this since it is unusual for them. His wife comes on the line at times to provide details throughout the call. For treatment, patient reported that he took Tylenol with aspirin, took a sinus pill called Mucinex, to make sure it was not his sinuses. Patient took a lot of stuff for the constipation. The events did not require emergency room and physician office visit. When asked for height, the patient thinks he was shrinking. Outcome of the event headache was recovered on 29Jan2021 while for other events was not recovered (reported as ongoing). Relevant test was reported as none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021149879 same reporter/drug/events, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Abdominal distension', 'Constipation', 'Flatulence', 'Headache']",1,PFIZER\BIONTECH,OT 1073532,WA,,F,"room was spinning; dizziness/ head feels light; This is a spontaneous report from a contactable consumer (patient). An 89-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration injected in the left arm on 28Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received her Pfizer vaccine 1st dose on 28Jan2021. The patient stated that on 01Feb2021, she woke up at 7:30 and her room was spinning. She sat on the edge of the bed and stated it lasted 10 min and the dizziness lasted for one hour or so. By noon, she stated she was back to ""almost normal."" She stated today (02Feb2021) that her head feels light. The outcome of the events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/01/2021,4.0,UNK,,,,,,"['Dizziness', 'Vertigo']",1,PFIZER\BIONTECH, 1073533,,,F,"Congestion; Headache; Felt a little lousy; Tired/fatigued; Cranky irritable; Sore throat/frog in my throat as you can hear; Body aches; ache in my right kidney; received the vaccine in my left arm and just had a little warmth; vaccine in my left arm was a little sore; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age (Age: 64; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL9264), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated, ""I received the pfizer covid vaccine on Sunday night at 6pm; I am having side effects, I have a little ethnic blood in me and am affected by viruses, the vaccines tend to nock me out. If I get a flu shot, I have a couple days of being tired. My first effect was on Monday when I woke up I had congestion and headache within 24 hours, felt a little lousy, tired, cranky, irritable and fatigued. The congestion was in my nose, then I had slight headache. I went to bed early, woke up this morning with a sore throat, checked my lymph nodes and there was no swelling. I have body aches and fatigue today and I am cranky and irritable because you I'm tired. The congestion, popped, it went away, from one minute to the next, it just cleared, it's like it popped out of your sinuses. I am also experiencing sore throat, frog in my throat as you can hear. I am going to take a nap. I received the vaccine in my left arm and just had a little warmth in that area later on, next day a little sore. I had an ache in my right kidney area also."" The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Fatigue', 'Headache', 'Irritability', 'Malaise', 'Nasal congestion', 'Oropharyngeal pain', 'Pain', 'Renal pain', 'Vaccination site pain', 'Vaccination site warmth']",UNK,PFIZER\BIONTECH, 1073534,WI,74.0,M,"put on a little weight; feeling sick; headache; chills; Ache; diarrhea; arm got sorer and sorer; This is a spontaneous report from a contactable consumer (patient). The consumer reported similar events for two patients. This is the first of two reports. A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot no. E10142, via an unspecified route of administration (administered to the left arm) on 19Jan2021 10:30 at a single dose for Covid vaccination administered at facility. Medical history included 100% disabled, Covid from Jul2020, hospitalized from 21Jul2020 to 26Jul2020, blood plasma, and sore. No relevant family medical history relevant to AEs. Concomitant medications included unspecified medications. The patient previously took remdesivir. The patient called to report side effects after getting the first Pfizer COVID vaccination. He got it on 19Jan2021. He had COVID before. Last summer he hadn't left the house for 20 plus weeks and their son who was living with them brought the COVID virus in to them. His son and wife were asymptomatic and suffered at the house and he was completely disabled, with underlying conditions had to drag himself to the facility. He eventually had to be hospitalized on 21Jul2020. He had blood plasma and remdesivir and stayed in the hospital from Tuesday through Sunday. After getting the treatment, he felt like superman. On 20Jan2021, he next day, about 24 hours later he started feeling sick again, he felt like when he had COVID back in Jul2020. It lasted for 24 hours, terrible headache, chills, aches, and a little diarrhea. He said after he got the vaccine, 24 hours later, his arm got sorer and sorer. He had 99.9 F fever and a terrible headache. He also put on a little weight on an unspecified date. No emergency room visit. No relevant tests. He called the facility the next morning and they told him to rest. He slept all day and the next day he felt like superman again. He called the facility that Thursday morning and they instructed him to relax and that it seemed to affect people who have had the COVID virus before, they have that reaction, and it should subside and it did. He stated his side effects were about 20% of what they were when he actually had COVID. The clinic told him that if he had any reaction to call and that Thursday he just relaxed. No other vaccines given the same day or 4 weeks prior. Never had any problems with shots, not really. He remembered when he went to specific area they gave him a whole bunch of shots with these guns and he was just sore a couple days, but that was it, no big deal. The patient underwent lab test which included COVID-19 positive Jul2020. The outcome of feeling sick, headache, chills, ache, diarrhea was recovering while outcome of other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107344 Same reporter/drug, similar events, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/20/2021,1.0,MIL,,,Medical History/Concurrent Conditions: Blood plasma substitute transfusion; COVID-19; Disability; Hospitalization; Pain,,,"['Body temperature', 'Chills', 'Diarrhoea', 'Headache', 'Malaise', 'Pain', 'SARS-CoV-2 test', 'Vaccination site pain', 'Weight', 'Weight increased']",1,PFIZER\BIONTECH, 1073535,FL,68.0,F,"she felt extreme pressure when she breathed, like an elephant sitting on her chest; Extreme chest pain/chest pain was not like a heart attack, but she felt a lot of pressure and weight when she was breathing in; heart rate went up (from 89 to 99); Pains; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiry date unknown), via an unspecified route of administration on the left arm on 24Jan2021 09:22 at a single dose for COVID-19 immunization. Medical history included degenerative disc disease (first disc came out) from 2007, chronic fibromyalgia from 2005, rheumatoid arthritis from 2000 (went into remission for a few years; while in remission, she was diagnosed with fibromyalgia), vertigo (diagnosed when she was 24 years old; bout of vertigo about twice a year; last year, 2020, was the worst bout of vertigo she ever had), allergy to shellfish (hives, itching, welts), sulfa (anaphylactic reaction), and mostly pain related issues. There were no concomitant medications. No additional vaccines administered on same date of the Pfizer suspect. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient wanted to know if she should get the second dose of the COVID vaccine knowing that she had a reaction to the first dose. She had a reaction which she believed was from the vaccine she received. She felt something immediately but did not concern herself with it, was kept for 30 minutes for observation. Her heart rate went up (from 89 to 99) and then her heart rate came back down. She said after the 30 minutes had gone by, she felt better. On 25Jan2021 and 26Jan2021, she felt extreme pressure when she breathed, like an elephant sitting on her chest which lasted all day. Patient woke up the next morning and pains were still there. It was also reported that the patient had extreme chest pain on 25Jan2021. She said that the chest pain was not like a heart attack, but she felt a lot of pressure and weight when she was breathing in. By the time she went to bed in the night of 25Jan2021 night, she felt fine. When she got up the next day, Tuesday, 26Jan2021, and started moving around, the chest pain came back. When she woke up on Wednesday, 27Jan2021, everything was all gone. Patient is scheduled for her second COVID-19 vaccine shot on 14Feb2021. The events did not require a visit to emergency room or physician office. The patient recovered from the chest pain on 26Jan2021, from heart rate went up on 24Jan2021, and from the other events in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/24/2021,01/01/2021,,UNK,,,"Medical History/Concurrent Conditions: Degenerative disc disease (first disc came out); Fibromyalgia; Pain; Rheumatoid arthritis (went into remission for a few years; while in remission, she was diagnosed with fibromyalgia); Shellfish allergy (hives, itching, welts); Sulfonamide allergy (anaphylactic reaction); Vertigo (diagnosed: 24 y/o, bout of vertigo about 2x/year, last year: worst bout of vertigo she ever had)",,,"['Chest discomfort', 'Chest pain', 'Heart rate', 'Heart rate increased', 'Pain']",1,PFIZER\BIONTECH, 1073536,,77.0,M,"had severe acid reflux; trouble breathing for about 15 minutes; was wheezing and sounded like an asthma attack.; Felt like something was stuck in his throat; He feels tired now; vomited lying down; Right now his throat is burning; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 01Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient woke up and had severe acid reflux, trouble breathing for about 15 minutes, couldn't catch his breath, was wheezing and sounded like an asthma attack. He felt like something was stuck in his throat. It cleared in 10 seconds and he could breathe and swallow fine. He took a Benadryl as treatment and drank water. He also felt tired. The patient further reported that he had the covid vaccine shot. He did not know if he was having a reaction, but he was taking a nap, and he guessed he regurgitated. He had a difficult time catching his breath, it was like it was stuck in the throat. He vomited lying down. He felt the stomach acid come up into mouth after he was able to breath better. But before he was not breathing at all. This never happened before. He was lying flat, he guessed he threw up. He had a large lunch, maybe too large. It was like he was getting something caught in in throat. The patient also reported that his throat was burning and mentioned that he slept on a triangular pillow. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,,,,,"['Burning sensation', 'Dyspnoea', 'Fatigue', 'Gastrooesophageal reflux disease', 'Sensation of foreign body', 'Vomiting', 'Wheezing']",UNK,PFIZER\BIONTECH, 1073537,,,F,"Not feeling good; Tossed and turned all night; Tiredness and mild aching; Really achy all over/felt achy; Little sick to stomach; Low-grade temperature; Feeling pretty bad; Little touch of headache; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 29Jan2021 11:45 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included fluticasone, cetirizine hydrochloride (ZYRTEC), azelastine, and colecalciferol (D3). The patient received the first dose of the COVID vaccine on Friday, 29Jan2021, at 11:45 in the morning. She had a little touch of headache on an unspecified date in 2021. On 30Jan2021, she reported feeling really achy all over, felt a little sick to stomach, a low-grade temperature, and feeling pretty bad, which she took Tylenol for. At 10:30 AM she took two more Tylenol and after that she still felt achy. Tylenol didn't touch it. She talked to a pharmacist who advised her to try and not take anything. She stated that the pharmacist was wondering if it will water down the effects of the COVID vaccine. Got through morning of Sunday, 31Jan2021, she reported she tossed and turned all night. She didn't feel like she had a fever, could have had a low-grade temperature. On 31Jan2021, morning at 09:30AM felt ok for two hours. Tiredness and mild aching were creeping back up on her. The other symptoms have since gone away, but the general feeling of tiredness has been going on for up to 4 days. On 01Feb2021, Monday, she felt tiredness like she didn't know if she could stay awake or not. She has tiredness and was not feeling good all over. It was day four at 12:00 PM. She was worried as to how long it would go on. She was looking for information on how long symptoms may last after vaccination and if any neurological symptoms were recorded during trials. She also wanted to know if side effects are more severe during the second dose of the vaccine compared to the first dose. She was so scared to get second COVID Vaccine on 19Feb2021. She heard some people do really well, and some people have been pretty sick for 48 hours. She was concerned about herself and this dragging on past four day. She wants to know if this has been heard of. The outcome of the event ""Little touch of headache"", ""Little sick to stomach"", ""Low-grade temperature"", and ""Feeling pretty bad"" was unknown, and for other events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,UNK,FLUTICASONE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; AZELASTINE; D3,,,,,"['Body temperature', 'Fatigue', 'Feeling abnormal', 'Headache', 'Insomnia', 'Malaise', 'Nausea', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH, 1073538,CT,24.0,F,"had a swollen lymph node under clavicle for a month; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient (currently 25-years-old) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration (at the age of 24-years-old) on 06Jan2021 12:45 at 0.3 mL, single in right deltoid for COVID-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: 31Mar2021), via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization. The patient had a swollen lymph node under clavicle for a month on 09Jan2021 13:00 with outcome of not recovered. She reported, ""I've had both doses of the vaccine. The last one was on 06Jan2021. I have had a swollen lymph node under clavicle for a month."" She says she got the second dose 06Jan2021 and on 09Jan2021 she was at the doctor's office and he felt what he thought is a swollen lymph node like under her clavicle, it is the size of a golf ball now, it is not going away. She says the swollen lymph node is under the clavicle on her left side. The doctor didn't seem too concerned about it but it has been almost a month and it is still there she doesn't know what it is but it is still there. She confirms the second dose was 06Jan2021 and on 09Jan2021 her doctor noticed it was swollen, she didn't even notice it before he did. She thinks it has gotten worse but she also might be freaking out for no reason but she thinks it has gotten bigger. She says she has the information for the first dose but the second dose is on another card because she forgot the card when she went back for the second dose. The information for the second dose is at home and she is not at home right now. She does not see an NDC Number. She says the lot number information could be available later if needed for follow up because the card is at home. Dose: It is not on the card but she thinks it is 0.3 ml, she doesn't remember for sure. At the time she got the dose she was being treated for ring worm. Her doctor did draw a Calcium and a PTH and they were both normal. She says the doctor was not too concerned about but it has been almost a month and it still has not gone down (as reported). She has asthma which she has been dealing with kind of on and off because this winter has been so cold but other than that nothing else has happened, her vitals are normal she did not even have any temperature or anything after the vaccine. The event was assessed as non-serious. Vaccination Facility Type was hospital. The adverse event did not require a visit to the Emergency Room or Physician Office. It was noted while she was in the doctors office but she has not had to go back for it. No prior vaccinations within 4 weeks. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/09/2021,3.0,PVT,,,Medical History/Concurrent Conditions: Asthma (Verbatim: Asthma),,,"['Blood calcium', 'Blood parathyroid hormone', 'Lymphadenopathy']",2,PFIZER\BIONTECH, 1073539,,,F,"headache; pain in her bones when she stretches; neck pain; difficulty in swallowing; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included being a smoker with a history of acid reflux. The patient's concomitant medications were not reported. The patient experienced side effects including headache, pain in her bones when she stretches, neck pain, and difficulty in swallowing on an unspecified date. The outcome of the events was unknown. The information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Acid reflux (oesophageal); Smoker,,,"['Bone pain', 'Dysphagia', 'Headache', 'Neck pain']",1,PFIZER\BIONTECH, 1073540,,,F,"Felt some pain on the injection site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 91, unit not provided) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location: arm right) on 21Jan2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported patient received the first dose of Pfizer vaccine on 21Jan2021. Patient mentioned that she did not have any bad reaction, but she cooks and cleans for herself and uses her right arm for those and felt some pain on the injection site. Patient wanted to know if she needs to rest for a while. Patient also mentioned that her second dose is due on 11Feb2021 and asked if it is possible to get the shot on the opposite arm. Outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,,,UNK,,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1073541,VA,51.0,M,"developed a COVID-19 infection/positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL8982), intramuscular on right arm on 16Jan2021 13:00 at single dose for COVID-19 vaccination. Medical history was none. There were no concomitant medications. The patient stated that after the first dose of the Pfizer Covid-19 vaccine he got sick and developed a COVID-19 infection. He got the first shot on 16Jan2021. He got sick a few days later on 20Jan2021 and he thought it may have been a sinus infection or side effects to the vaccine. He got tested for Covid-19 last Monday 25Jan2021 and it came back positive. He clarified that he started feeling like he had a sinus infection, and reported congestion, feeling run down, and cold symptoms. He was still experiencing congestion and a occasional headaches. The sick was recovering. The events did not require a visit to Emergency Room or Physician Office. He was scheduled to get the second dose tomorrow 03Feb2021 and he was over the quarantine, wanted to know if he is still able to get the second dose. The writing on the sticker on his vaccination card was very little. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to vaccinations. The report was reported as non-serious. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,01/20/2021,4.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1073542,MI,57.0,F,"Hives on both arms about 5 hours after second injection. Spread to my legs 5 days later; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249 and expiration date not provided), via an unspecified route of administration in the left arm on 27Jan2021 13:45 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food or other products. Concomitant medications included metformin, colecalciferol (VITAMIN D), biotin and multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) on 06Jan2021 13:45 in the left arm at the age of 57 years old for Covid-19 Immunization. On 27Jan2021 18:00, the patient experienced hives on both arms about 5 hours after second injection which spread to the patient's legs 5 days later. The patient saw her PCP today and she felt it was related to vaccine. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included antihistamine. The outcome of the event was not recovered. The reporter assessed the event as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,OTH,METFORMIN; VITAMIN D [COLECALCIFEROL]; BIOTIN,,,,,['Urticaria'],2,PFIZER\BIONTECH, 1073543,NV,72.0,M,"lower right side back pain, Knee joints hurt and all of his joints hurt; lower right side back pain, Knee joints hurt and all of his joints hurt; This is a spontaneous report from a contactable consumer reported for himself. A 72-year-old male patient stated received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unknown date (at the age of 72-years-old) at single dose for COVID-19 immunization. Relevant medical history included arthritis and concomitant medications were not reported. Right after the vaccination the patient experienced lower right side back pain, Knee joints hurt and all of his joints hurt, but they subsided. The patient had received a flu shot 4-5 months before and he took some herbs. The patient was not sure if it was his arthritis or the vaccine. Information about batch number was not available and is going to be requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: Arthritis,,,"['Arthralgia', 'Back pain']",1,PFIZER\BIONTECH, 1073544,,,F,"Received the vaccine in the right arm and it felt like it went to sleep from the elbow down; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at site of right arm on 02Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced received the vaccine in the right arm and it felt like it went to sleep from the elbow down. it's been about 2 hours and is persisting. The outcome of event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,,,UNK,,,,,,['Hypoaesthesia'],1,PFIZER\BIONTECH, 1073545,TX,,M,"cough; cold sweat; fatigue; fever; severe headaches; loss of taste; joint and muscle pain; joint and muscle pain; This is a spontaneous report from a contactable consumer. An elderly male patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL8982), via an unspecified route of administration on 22Jan2021 14:30 at a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Medical history included blood pressure high (HBP), diabetic; both from an unknown date and unknown if ongoing. Concomitant medications included unspecified medications taken for an unspecified indication from an unspecified date to an unspecified date; taken within two weeks of vaccination. The patient had no allergies to medications, food, or other products. On 26Jan2021, the patient experienced: cough (non-serious), cold sweat (non-serious), fatigue (non-serious), fever (non-serious), severe headaches (non-serious), loss of taste (non-serious), joint and muscle pain (non-serious); which resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of cough, cold sweat, fatigue, fever, severe headaches, loss of taste, joint and muscle pain; which included unspecified cough medications, nausea medications and paracetamol (TYLENOL). The clinical outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/26/2021,4.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure high; Diabetic,,,"['Ageusia', 'Arthralgia', 'Cold sweat', 'Cough', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1073546,,,F,"She said that prior to getting the vaccine, she had experienced headache and it got worse after taking the shot.; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunization. Medical history included headache. The patient's concomitant medications were not reported. The patient got the vaccine on 29Jan2021. Her brother-in-law was advised to drink a lot of water and not to take anything at all. She said that prior to getting the vaccine, she had experienced headache and it got worse after taking the shot. Her vaccination provider did not tell anything to her about drinking lots of water. She took ADVIL for her headache. She would like to know what the protocols were after taking the shot. The patient asked ""Would you refrain from taking Tylenol, ibuprofen, and aspirin? "" and ""Do you happen to know if you wouldn't take the second shot... I have heard you might still have immunity?"" The outcome of the event was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,,,UNK,,,Medical History/Concurrent Conditions: Headache,,,['Headache'],1,PFIZER\BIONTECH, 1073547,FL,,F,"a rash on the vaccine area on the left arm; terrible headache; chills; a rash on the vaccine area on the left arm. It started terribly itching; nausea; I sweat the first night, noticed it when got up to use the restroom; The injection site area was hot; This is a spontaneous report from a contactable Consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2) via an unspecified route of administration in left arm on 26Jan2021 09:00 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received 2nd dose on 26Jan2021 at 9am, in the evening, started with terrible headache and chills, then itching started, in between she was having nausea, her arm had a rash on the vaccine area on the left arm. It started terribly itching, she had to scratch, she took a diphenhydramine (BENADRYL), didn't do much. The first side effect she had headache chills nausea, subsided after the second day. They were lower by second day and she still had the nausea that ended on the 4th day. On 02Feb2021 she still had some itching, not as bad but still itches. When she had the chills, when they would stop she would sweat a little, but she didn't feel like got hot, she sweat the first night, noticed it when got up to use the restroom. The rash was really uncomfortable. She tried using cold water in the area and it seemed to relieve some of what she was feeling. The injection site area was hot, it started when the itching started and lasted when it went down, she still had a little bit of the rash, it was a little hotter then the rest of her arm, but not as bad as it was. She asked her doctor if she could take diphenhydramine, he said it could help her if it was an allergic reaction, but it didn't do much for her. The outcome of events a rash on the vaccine area on the left arm, terrible headache, chills was recovering, outcome of event itching was not recovered, outcome of events nausea was recovered, outcome of events sweat, the injection site area was hot was unknown. Information on Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,,,UNK,,,,,,"['Chills', 'Headache', 'Hyperhidrosis', 'Nausea', 'Vaccination site pruritus', 'Vaccination site rash', 'Vaccination site warmth']",2,PFIZER\BIONTECH, 1073548,,,U,"tested positive after receiving the vaccine; tested positive after receiving the vaccine; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The nurse reported that the patient was tested positive after receiving the vaccine. The nurse asked if this had been an increasing occurrence. The nurse asked if someone was positive for covid but was unknowing positive was asymptomatic and did take the vaccine, what are the dangers. The nurse asked for information on efficacy if the interval is longer than 21 days, if it is the same efficacy. The outcome of the events was unknown. Information about batch/lot number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and Covid 19 cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1073549,CT,42.0,F,"Sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the right arm, on 02Feb2021 at 10:00 (at the age of 42-years-old) at a single dose for COVID-19 immunisation. Medical history included asthma, allergy to animals, allergy to pineapple, and allergy to raw onion. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included levocetirizine dihydrochloride (XYZAL). The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced allergy. The patient experienced sore arm at injection site on 02Feb2021 at 17:00. The event was reported as non-serious. The patient did not receive any treatment for the event. The clinical outcome of sore arm at injection site was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/02/2021,0.0,WRK,XYZAL,,Medical History/Concurrent Conditions: Allergy to animals; Asthma; Fruit allergy; Vegetable allergy,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1073550,,78.0,F,"Slight feeling of swelling within the mouth; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm, on 01Feb2021 at 11:00 (at the age of 78-years-old) at a single dose for COVID-19 immunisation. Medical history included high blood pressure, indolent follicular lymphoma (not under treatment, but being watched), and allergy to cat dander. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 11Jan2021 (at the age of 78-years-old), in the right arm, for COVID-19 immunisation and erythromycin estolate (ILOSONE) as an antibiotic and experienced allergy. The patient experienced slight feeling of swelling within the mouth on 01Feb2021 at 11:30. The event was reported as non-serious. It was reported that the patient felt the swelling in the mouth after the 15 minute wait. The patient did not receive treatment for the event. The clinical outcome of slight feeling of swelling within the mouth was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,PVT,,,"Medical History/Concurrent Conditions: Allergy to animal dander; Blood pressure high; Follicle centre lymphoma, follicular grade I, II, III (not under treatment, but being watched)",,,['Mouth swelling'],2,PFIZER\BIONTECH, 1073551,GA,67.0,F,"Chills; Headache; Severe sweats; Nausea; Runny nose; Fever; Vomiting; It was positive for Covid and negative for the antibodies the Nurse told me; It was positive for Covid and negative for the antibodies the Nurse told me; It was positive for Covid and negative for the antibodies the Nurse told me; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation. Medical history included diabetes mellitus. The patient's concomitant medications were not reported. The patient experienced positive for covid and negative for the antibodies on 02Feb2021, chills, headache, severe sweats, nausea, runny nose, fever, vomiting on an unspecified date. The outcome of events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,02/02/2021,13.0,UNK,,,Medical History/Concurrent Conditions: Diabetic,,,"['COVID-19', 'Chills', 'Drug ineffective', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pyrexia', 'Rhinorrhoea', 'SARS-CoV-2 antibody test negative', 'SARS-CoV-2 test', 'Vomiting']",1,PFIZER\BIONTECH, 1073552,,66.0,F,"headache; This is a spontaneous report from a contactable consumer (patient). This 66-year-old female consumer received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 26Jan2021 for Covid-19 immunization. Medical history included eczema and lowered the immune system. Concomitant drug included dupilumab (DUPIXENT) for eczema for 1.5 years (as of 02Feb2021) which she gives herself a shot in the stomach every 2 weeks. She stated dupilumab affects the immune system and lowers the immune system. She was previously unaware of this and took the first dose of the Pfizer Covid 19 vaccine and only had a headache as a side effect. She took the dupixent either the day before, day of, or the day after the first dose of the vaccine, so the 25Jan2021, 26Jan2021, 27Jan2021, she had it on the 26Jan2021, and wondering if this impact the efficacy of the first dose. She was scheduled to take dupilumab on 09Feb2021 and second dose of the vaccine on 16Feb2021. Patient had no kind of bad interactions, she had a headache which was her only symptom. Outcome of the event was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/26/2021,0.0,UNK,DUPIXENT,,Medical History/Concurrent Conditions: Decreased immune responsiveness,,,['Headache'],1,PFIZER\BIONTECH, 1073553,,,M,"had covid; had covid; This is a spontaneous report from a contactable other health professional (patient's wife). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose as Covid vaccine. The patient's medical history and concomitant medications were not reported. The patient had covid on 14Jan2021 and was due for his second vaccine today. He was advised not to get it because he got Remdesiver. The reporter wanted to know where he can get the second dose. The outcome of the events was unknown. Information about the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/14/2021,,UNK,,,,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1073554,TX,30.0,F,"itching (itching affected her upper body, face, shoulders and torso).; This is a spontaneous report from a contactable nurse (patient) received via Medical Information Team. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at arm left on 13Jan2021 at 12:00 (at the age of 30 years) at single dose for COVID-19 immunization. Medical history included pregnancy from an unknown date to an unknown date, dual venous thrombosis post pregnancy (from two years and four months ago) and blood thinner from an unknown date and ongoing. Concomitant medication included warfarin oral at 7.5 mg once a day from an unknown date and ongoing for blood thinner. The patient experienced itching (itching affected her upper body, face, shoulders and torso). The patient outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,,,PVT,WARFARIN,Anticoagulant therapy; Venous thrombosis in pregnancy (from two years and four months ago),Medical History/Concurrent Conditions: Pregnancy,,,['Pruritus'],1,PFIZER\BIONTECH, 1073555,,70.0,F,"suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; congestion; running nose; This is a spontaneous report from a contactable consumer reporting for his/her mother. A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Jan2021 (when 70 years old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, congestion, running nose, chills, cough, covid 19 symptoms on 02Feb2021 with outcome of unknown. The reporter wanted to know what kind of the covid test should she get done and if the patient could take the second dose on 08Feb2021 or should she wait. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,02/02/2021,14.0,UNK,,,,,,"['Drug ineffective', 'Nasal congestion', 'Rhinorrhoea', 'Suspected COVID-19']",1,PFIZER\BIONTECH, 1073556,IL,20.0,F,"Dizziness; Headache; Chills; Muscle Aches; Pain in right arm; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), via an unspecified route of administration on 02Feb2021 at 12:45 PM (at the age of 20-years-old) at single dose in right arm for COVID-19 immunisation. The patient was vaccinated at Public Health Clinic/Administration facility. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no known allergies. Medical history includes insomnia and migraines. Concomitant medications included eszopiclone (LUNESTA), melatonin, ibuprofen, bismuth subsalicylate (PEPTOBISMOL). On 02Feb2021 at 15:00 the patient experienced dizziness, headache, chills, muscle aches, pain in right arm. No treatment was given for the events. The events were resolving. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,PUB,LUNESTA; MELATONIN; IBUPROFEN; PEPTOBISMOL,,Medical History/Concurrent Conditions: Insomnia; Migraine,,,"['Chills', 'Dizziness', 'Headache', 'Myalgia', 'Pain in extremity']",1,PFIZER\BIONTECH, 1073557,,59.0,F,"her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a lacey honeycomb pattern of red with white blotches; her cheeks were bright red; top of her hands to her wrist and lower arms were very red; felt light headed/faint and dizzy; tightness in her chest; the tightness that she felt the day before was in her lungs or throat; This is a spontaneous report from a contactable Physician reporting for his/her sister. A 59-year-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration at single dose in Jan2021 (12 days before reporting) for COVID-19 immunisation. Medical history included Hashimoto's autoimmune disease, enlarged thyroid, goitre. The patient's concomitant medications were not reported. In Jan2021, as soon as she got the injection, the patient felt both her hands swelling and tightness, underside of the forearms had a lacey honeycomb pattern of red with white blotches, top of her hands to her wrist and lower arms were very red, her cheeks were bright red, felt light headed/faint and dizzy, tightness in her chest and thought it was her heart. She was monitored for an hour but was told it probably wasn't an allergic reaction. Symptoms began to fade at that time. Next day she felt good and thought the tightness that she felt the day before was in her lungs or throat. The outcome of events was recovering. The events were reported as non serious. Reporter was referred to HCP or vaccination provider to determine if this was a severe allergic reaction and if she should receive the second dose of the vaccine. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,UNK,,,"Medical History/Concurrent Conditions: Enlarged thyroid (She also has an autoimmune disease, Hashimoto's, and enlarged thyroid.); Hashimoto's disease (She also has an autoimmune disease, Hashimoto's, and enlarged thyroid.)",,,"['Chest discomfort', 'Dizziness', 'Erythema', 'Musculoskeletal stiffness', 'Peripheral swelling', 'Rash erythematous', 'Skin disorder', 'Throat tightness']",UNK,PFIZER\BIONTECH, 1073558,,,F,"seasonal allergies; This is a spontaneous report from a contactable consumer reporting for herself. This female patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had her 1st vaccine and had seasonal allergies since an unknown date. The patient wanted to know if it was ok to take a Benadryl. Event outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,,,UNK,,,,,,['Seasonal allergy'],1,PFIZER\BIONTECH, 1073559,GA,,M,"had a sore arm; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for 2 patients. This is 2nd of 2 reports. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history included disabilities which patient will be miserable from an unknown date and unknown if ongoing (patient's mother clarified patient had disabilities before taking the Pfizer Covid vaccine). The patient's concomitant medications were not reported. It was reported that patient had the first Pfizer vaccine couple of weeks ago (unspecified date) and had no side effect except only had a sore arm. It was also reported that patient will have the second one next Wednesday (unspecified date). It was further reported that the next day (unspecified date), there was no soreness. Patient's mother stated that she read that it is not safe to take Ibuprofen or Tylenol because it will decrease effectiveness. Wanted to know if this is true. Outcome of the event was recovered. Information of lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107036 same drug/event/reporter, different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: Disability,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1073560,GA,,F,"had a sore arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. This consumer reported similar events for 2 patients. This is the 1st of 2 reports. A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she had her first vaccine a couple of weeks ago and had no side effects except only had a sore arm on an unspecified date and the next day there was no soreness. She heard that the side effects with the second one will be worst and that she read that it was not safe to take Ibuprofen or Tylenol because it will decrease effectiveness. She wanted to know if this was true as they will have the second one next Wednesday. Patient stated that she knows that the headaches and fevers were harder with second one. Outcome of event was recovered on unspecified date. Information of lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107024 same reporter, drug and event; different patient.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1073561,WA,76.0,M,"Shortness of Breath; Asthma; Cough; he is experiencing asthma, shortness of breath and a cough/he has had these symptoms previously but it was cleared up and then he had the shot and it hit him again last night; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: May2021), via an unspecified route of administration on the left arm, on 28Jan2021 08:10, at single dose, for COVID-19 immunization, at the hospital. Medical history included cholesterol, blood pressure, coronary artery bypass in 2008, asthma, shortness of breath and cough which the patient already had before receiving the vaccine. Ongoing concomitant medications included rosuvastatin calcium (CRESTOR) for cholesterol and losartan for blood pressure. The patient did not receive any prior vaccinations within four weeks. On 01Feb2021, the patient experienced asthma, shortness of breath and cough. The patient stated that he already had these symptoms before receiving the vaccine and clarified he has had these symptoms previously, but it was cleared up and then he had the shot and it hit him again. He added that last night, on 01Feb2021, he had to sit in a chair all night due to the coughing. He did take some albuterol in his nebulizer and he was better on 02Feb2021. He was asking if he can take prednisone between doses of the Pfizer COVID 19 vaccine. His second dose was scheduled on 19Feb2021. The events did not require visit to a physician or emergency room. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/01/2021,4.0,PVT,CRESTOR; LOSARTAN,,Medical History/Concurrent Conditions: Asthma (already had these symptoms before receiving the vaccine); Blood cholesterol abnormal; Blood pressure abnormal; Coronary artery bypass; Cough (already had these symptoms before receiving the vaccine); Shortness of breath (already had these symptoms before receiving the vaccine),,,"['Asthma', 'Cough', 'Disease recurrence', 'Dyspnoea']",1,PFIZER\BIONTECH, 1073562,MI,73.0,M,"slight headache; achy muscles in back behind ribs; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received the first dose of BNT162B2 ( PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1283), on the left arm, intramuscularly on 01Feb2021 at 16:40 at single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was taking an unspecified health pills. The patient receives a flu shot every year and has never had a problem. No vaccines were administered on the same day and no prior vaccinations within 4 weeks. The patient reported that he received the vaccine on 01Feb2021 and on the same night experienced a slight headache which recovered the next day on 02Feb2021. The patient also reported that he is achy in his back, states it is the muscles in his back behind his ribs that is achy on 01Feb2021. The achiness is mild right now, seems to be fading, states it has recovered about 50%. He has no fever. patient added that he had previously seen somewhere online that pre medicating for side effects prior to receiving the vaccine can reduce the effectiveness of the vaccine. He did not take anything prior to getting the vaccine. He heard from his daughter the second dose of the vaccine is a whopper. How soon after the vaccine can something like acetaminophen or ibuprofen be taken? The events did not require physician office or emergency room visit. The patient denies receiving treatment for the events. The patient was vaccinated in a hospital. The outcome of the event slight headache was recovered on 02Feb2021 while for the event muscles in his back behind his ribs that is achy was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,PVT,,,,,,"['Back pain', 'Headache']",1,PFIZER\BIONTECH,OT 1073563,,32.0,F,"Fever; myalgia; chills/rigor; severe headache; fatigue; dizziness; This is a spontaneous report from a Non-contactable Physician (patient). A 32-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3248), via an unspecified route of administration on 29Jan2021 (at the age of 32-years) at single dose for COVID-19 immunisation. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history includes seasonal allergies. The patient received no concomitant medications. On 29Jan2021 the patient experienced fever, myalgia, chills, rigor, severe headache, fatigue and dizziness. Treatment was received for the events with Ibuprofen and Tylenol. The events had resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Seasonal allergy,,,"['Body temperature', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1073564,LA,72.0,F,"left eye felt tight and felt itchy/severe tightness in her left eye; intense itching in inner ear where you cannot scratch; severe tightness in her left eye that felt like it was going to swell up; hot skin for several hours; hot flashes; She has itching in ears and throat; Onset of burning and itching; Skin had feeling of about to break out in hives/full blown body hives all over; This is a spontaneous report from a contactable nurse. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3249), intramuscular on the right arm, at the age of 72 years, on 13Jan2021 09:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient would like to know if the vaccine was derived from or does it have any products from Acacia. One of the reason's she was asking was because she knows it has Polyethylene Glycol in it. Her resources are limited. She was a retired healthcare provider and she taught graduate level nursing and has background in epidemiology and public health. The Polyethylene Glycol was in the vaccine, according to the prescribing information. Some forms of Polyethylene Glycol in some type of way are derived from gum acacia and she does not know if this is the case for the COVID vaccine. She did have 1st dose and waited 15 minutes. When her left eye felt tight and felt itchy, she took 2 Benadryl and then waited in car a little longer. She felt like she was going to go into what she has had in past 3-4 times relating to fish. She has had full blown facial swelling, intense itching in inner ear where you cannot scratch. Those times, if she had chopsticks, she would want to scratch inside her ear. She never had that with the COVID vaccine. They told her when she got the vaccine that if this develops further, she should go to her doctor or ER, but should not come back there. She did not want to go to the ER and sit there for 12 hours waiting to see if she was going to have a worse reaction, so she went home, took 2 more Benadryl, and went to bed. Eight hours later, she was fine and did not have hives. She then stated she completed report with Pfizer online and did not have a reference number for previous report. For those time when she had these episodes with the fish, she had extreme itching and hives. The worst allergy she had, her fingers looked like they were webbed. She was treated with Adrenaline, Cortisone and Benadryl by injection and that would usually stop the reaction, but it usually takes 3-4 days for the swelling to go down. In later years, if there is a piece of fish mixed in with fried shrimp and she inadvertently eats it, she knows it immediately. She will take Benadryl immediately. She will have facial swelling and swelling around her eyes. The Benadryl will contain it. She will be disfigured for 2 weeks, with bags of fluid in her cheeks. She is going for her second shot tomorrow. She can self treat with Benadryl. In 1994, she had a very positive wheels from an intradermal scratch testing for Acacia and codfish. The patient had an onset of burning and itching, periorbital. She took 2 25 mg Benadryl tablets. She has itching in ears and throat. After my 15 minutes waiting, she left. She had various hot spots of burning skin, legs and arms. Left eye felt like past episodes of itching, about to swell. Her skin had feeling of about to break out in hives. Facility said to go to provider or ER if got worse. She chose not to go to ER, and wait and be miserable for hours on end, while waiting for full blown body hives all over. She took two more 25 mg Benadryl and went to bed. She had intermittent burning skin, various areas, for several hours. About 8 hours later, was resolved. The patient was about to receive 2nd dose of the Covid vaccine. After the 1st dose she experienced an itchy feeling in throat, rotating heat in arms and legs, slight bag fluid under left eye and it felt to her like she was going to have an allergic reaction but did not. She took some Benadryl and after 8 hours she was fine. The patient stated after the first dose of the vaccine she had itching, severe tightness in her left eye that felt like it was going to swell up, and hot skin for several hours. She took two Benadryl while she was still in the waiting period and perhaps that blunted the reaction. She had hot flashes on the drive home. She took two more Benadryl at her daughter house (100mg total after taking 4 that day). She didn't feel good and felt she was on the verge of getting hives. She had episodes of hot skin and itching and after 8 hours it was over and done with and she was fine. She stated she is nervous about the second dose but stated they have what they need if she has an immediate reaction and it is worth the risk of getting vaccinated. Therapeutic measures were taken as a result of left eye felt tight and felt itchy/severe tightness in her left eye (eye pruritus), intense itching in inner ear where you cannot scratch (ear pruritus), onset of burning and itching (skin burning sensation), skin had feeling of about to break out in hives/full blown body hives all over (urticaria). The outcome of the event onset of burning and itching and skin had feeling of about to break out in hives/full blown body hives all over was recovered on an unspecified date while other events were unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Fish allergy,,,"['Ear pruritus', 'Eye pruritus', 'Eye swelling', 'Hot flush', 'Skin burning sensation', 'Skin warm', 'Throat irritation', 'Urticaria']",1,PFIZER\BIONTECH,OT 1073565,NY,55.0,M,"I received the first dose on 27Jan and got diagnosed yesterday with Covid; His son tested positive for COVID-19 on Monday and he tested positive on Tuesday, 02 Feb 2021; Loss of smell; This is a spontaneous report from a contactable lawyer. A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: EL8982, expiration date: May2021), intramuscular on the left arm on 27Jan2021 at a single dose for COVID-19 immunisation. The patient medical history was none. Prior Vaccinations (within 4 weeks) was none. Concomitant medications were not reported. The patient previously took penicillin and aspirin [acetylsalicylic acid] and experienced Allergies. The patient explained he was calling for some advice. He received the COVID-19 vaccine on 27Jan2021, time the vaccination was given was 10:30, maybe 10:45am. His son tested positive for COVID-19 on monday and he tested positive on tuesday, 02Feb2021. Patient was eligible to receive the monoclonal antibody therapy. He wanted to know since he had already one vaccine and questioned will this create any conflict with receiving the second vaccine. Patient also questioned will there be any danger with receiving the monoclonal antibody therapy since he already had the first COVID-19 vaccine. Reporter stated he worked with healthcare professional, but he was not one. He worked as an attorney and works in the hospital on occasion. Patient wanted to know what the best protocol was to protect him, will the vaccination he took protect him to some degree and will it interfere with him having monoclonal antibody therapy tomorrow morning questioned. He wanted to contact Pfizer first to see if there was anything he needed to know or if there was some sort of bad synergy with the injection. Description of complaint was patient stated he had a COVID-19 Rapid test done yesterday (02Feb2021) which was positive. He was certain he was positive. He loss his sense of smell the night before (01Feb2021). Patient stated he had COVID-19 PCR test too, but he had not got the results back yet. The outcome of the events was unknown. No further information was provided or obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,02/01/2021,5.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Anosmia', 'COVID-19', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1073566,,30.0,F,"Arm soreness; Minor fatigue; This is a spontaneous report from a contactable consumer (reporting for herself). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3247), via an unspecified route of administration single dose arm left (at the age of 30) on 02Feb2021 for covid-19 immunisation. No other vaccine was received in four weeks. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arm soreness on 02Feb2021, minor fatigue on 02Feb2021. No treatment received. The events outcome was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,WRK,,,,,,"['Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH, 1073567,CT,61.0,M,"sore arm at injection site; tiredness; feeling unwell; loss of appetite; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3247 and expiration date: unknown), via an unspecified route of administration on 02Feb2021 at 11:30 at a single dose for COVID-19 immunization. Medical history included likely COVID in Apr2020 based on a video call with his physician. Concomitant medications included celecoxib (CELEBREX), gabapentin (NEURONTIN), zinc (ZINC), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), ascorbic acid (VIT C), colecalciferol (VIT D3), and cyanocobalamin (VIT B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm at injection site, tiredness, feeling unwell and loss of appetite on 02Feb2021 at 18:00. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19. The events had not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,WRK,CELEBREX; NEURONTIN; ZINC; ASPIRIN [ACETYLSALICYLIC ACID]; VIT C; VIT D3; VIT B12,,Medical History/Concurrent Conditions: COVID-19,,,"['Decreased appetite', 'Fatigue', 'Malaise', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 1073568,CA,51.0,M,"Numb and tingly face; Numb and tingly face; Fatigued; lethargic; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN 5318), via an unspecified route of administration left arm single dose on 02Feb2021 14:30 (at the age of 51) for covid-19 immunisation. The patient medical history included covid 19 with mild symptoms on 29Dec2020. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. The patient experienced numb and tingly face, both on 02Feb2021 18:00, fatigued and lethargic on 02Feb2021 8-36 hrs after vaccination. The events outcome was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,WRK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Fatigue', 'Hypoaesthesia', 'Lethargy', 'Paraesthesia']",1,PFIZER\BIONTECH, 1073569,,,F,"restless leg; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age (age: 71; unit: unknown) started to received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed a restless leg on unspecified date. The patient elevated it on some pillows and it subsided within a few hours. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected. Information regarding Lot/Batch No. cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Restless legs syndrome'],2,PFIZER\BIONTECH, 1073570,,26.0,F,"nausea; vomiting; chills; joint and muscle pain; joint and muscle pain; headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, at the age of 26-year-old, on an unspecified date, at SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on an unspecified date, single dose for COVID-19 immunization. On an unspecified date, following administration of second COVID-19 vaccine, the patient experienced nausea and vomiting, chills, joint and muscle pain, headache, and fatigue. Onset of symptoms occurred approximately 5 hours after administration of medication and became progressively worse over the next 20-24 hours following administration of dose. Symptoms began to resolve around 26 hours post administration of medication. Outcome of the events was recovering at the time of the report. No follow-up attempts are possible. Information about batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH, 1073571,TX,,U,"the injection site was getting a little swollen; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect via a contactable consumer. The patient of unspecified age and gender received first dose BNT162B2 , via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient got first shot this morning on 02Feb2021. Right now, the injection site was getting a little swollen. Patient took a tramadol as treatment. Outcome of event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/02/2021,0.0,UNK,,,,,,['Vaccination site swelling'],1,PFIZER\BIONTECH, 1073572,PA,,F,"swelling in her hands; the underside of her forearms had a honey comb pattern, almost like a lattice, of redness, all over both forearms; her cheeks and face were a brighter, lighter red, but her hands were a darker red; This is a spontaneous report from a contactable healthcare professional (patient's brother) via a Pfizer-sponsored program, . A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown, via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a sort of immediate reaction. After the patient got the vaccine, immediately she started to feel her hand swell, and then both her hands were swollen, and she was unable to bend her fingers. They waited the standard 15 to 20 minutes after receiving the medication, and when the patient turned her arms over, the underside of her forearms had a honey comb pattern, almost like a lattice, of redness, all over both forearms. The top of the patients hands were very red, really red, and her cheeks and face were a brighter, lighter red, but her hands were a darker red. Reporter got the attention of someone, who turned out to be a Pharmacist, and the Pharmacist checked patient out to make sure she was okay. Patient was responsive, so in that aspect she was okay. The reporter was wondering about this, and wondering about if this is a known side effect of the product. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Erythema', 'Peripheral swelling', 'Rash macular']",1,PFIZER\BIONTECH, 1073573,OH,,F,"weakness; dizziness; headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was experiencing weakness, dizziness and headache after receiving her first dose of COVID-19 Vaccine. The outcome of the event was not recovered at the time of report. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Asthenia', 'Dizziness', 'Headache']",1,PFIZER\BIONTECH, 1073574,CT,54.0,M,"Deltoid soreness; This is a spontaneous report from a contactable pharmacist (patient himself). A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 04Feb2021 10:00 AM at single dose for COVID-19 immunization in facility type of other. The patient's medical history included COVID-19 (the patient was diagnosed with COVID-19 prior to vaccination). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. On 05Feb2021 05:00 AM, the patient experienced deltoid soreness. The event was considered as non-serious by the pharmacist. No treatment was received for the adverse event. The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,UNK,,,Medical History/Concurrent Conditions: COVID-19 (The patient was diagnosed with COVID-19 prior to vaccination.),,,['Myalgia'],1,PFIZER\BIONTECH, 1073575,OH,80.0,F,"She did not feel good; Eyes were blurry/ she felt pressure in them; Bad head cold; she couldn't bend over; Aches all over; Back pain; Eyes were blurry/ she felt pressure in them; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1687), via an unspecified route of administration on the left arm, at the age of 80 years, on 29Jan2021 17:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included cataract, arthritis and seasonal allergy from an unknown date and unknown if ongoing. There were no concomitant medications.The patient stated that a couple of times she did not feel good and got very sore and could not bend over to pick things up and her eyes blurred up. After she got the shot, she gradually noticed aches all over and back pain. It was stated it hurt really bad in her back on the right side on the bone and she used the heating pad on it. Then the next day she was stiffer than ever and she couldn't bend over. She added her eyes were blurry, they felt like she had a cold in them, and she felt pressure in them. She added she always has this problem with her eyes but it got a little worse after the shot. All of that has gotten better now. It was stated they are telling her the second dose was worse and she was unsure about getting the second dose. Also mentioned they were saying you can wait a little longer and she was unsure if maybe she should wait. She wanted to ask about getting the second dose. She added she was scheduled to receive the second dose of the vaccine on 19Feb2021. The patient said it was right sided back pain. She said she applied heading pad and took ibuprofen. She also experienced ""eye pressure"" and ""blurry eyes"", ""how you feel when you have a bad head cold"". She said, ""I have allergies-seasonal, so this isn't new to me"". Therapeutic measures were taken as a result of back pain (back pain). The outcome of the events did not feel good, eyes were blurry/ she felt pressure in them and bad head cold was unknown while other events were recovered on 31Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Arthritis; Cataracts; Seasonal allergy (I have allergies-seasonal),,,"['Back pain', 'Malaise', 'Movement disorder', 'Nasopharyngitis', 'Ocular discomfort', 'Pain', 'Vision blurred']",1,PFIZER\BIONTECH, 1073576,,,F,"exhaustion; achiness; headache; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 29Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got vaccinated on Friday (29Jan2021). The patient experienced exhaustion, achiness, and headache on an unspecified date. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,,,UNK,,,,,,"['Fatigue', 'Headache', 'Pain']",UNK,PFIZER\BIONTECH, 1073577,,,M,"Her husband got a bad covid outbreak after first dose; Her husband got a bad covid outbreak after first dose; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (herself and her husband). This is second (husband) of two reports. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that on an unspecified date her husband (patient) got a bad Covid outbreak after first dose and the location closed. The patient does not know where to get second dosage. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1073578,,,F,"has been experiencing arm pain since administration from injection site all the way down to her fingers; This is a spontaneous report from a Pfizer-sponsored program via contactable other healthcare professional (patient). A female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2, lot/batch number and expiry date were not reported), via an unspecified route of administration in arm on an unspecified date at SINGLE DOSE for Covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had been experiencing arm pain since administration from injection site all the way down to her fingers on an unspecified date. She had tried everything she can think of to subside the pain but nothing has been working. The outcome of event was not recovered. Information on Lot/ Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1073579,NJ,,F,"her blood pressure increased; She felt like her skin in the neck was burned; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported for herself. A female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced blood pressure increased on an unspecified date with outcome of unknown , she felt like her skin in the neck was burned on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: increased. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Blood pressure increased', 'Blood pressure measurement', 'Skin burning sensation']",1,PFIZER\BIONTECH, 1073580,CA,,F,"severe pain; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received her second dose of bnt162b2 (BNT162B2 reported Covid-19 Vaccine; unknown lot number and expiration date) at unknown age of vaccination via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of bnt162b2 (BNT162B2 reported Covid-19 Vaccine; unknown lot number and expiration date) at unknown age of vaccination via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient reported that she herself had severe pain after getting second dose (unspecified date) so she's worried about giving the patient. She also reported ""The covid vaccine that had the breast removal- Wondering if we have any recommendations for the patient"". The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain'],2,PFIZER\BIONTECH, 1073581,NC,,M,positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer reported that a male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient has gotten really sick and tested positive for COVID-19 on unspecified date in 2021. Outcome of the event was unknown. Information about Lot/Batch has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1073582,FL,,F,"Fever; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 ( PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient got fever and wants to know if she can take aspirin. The outcome of the event was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pyrexia'],2,PFIZER\BIONTECH, 1073583,NY,,U,"reported minor pain and slight tiredness; reported minor pain and slight tiredness; This is a spontaneous report from a non-contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient reported that overnight (Feb2021) he/she experienced minor pain and slight tiredness, however the tiredness could have been related to a late night due to snowstorm. Both the events were considered as non-serious. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,,,,,"['Fatigue', 'Pain']",UNK,PFIZER\BIONTECH, 1073584,ND,,M,"sugar level spikes; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reporting on behalf of the husband reported that a male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, 4 days after vaccination, the patient experienced sugar level spikes. The patient was on diabetes medication. Event outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Blood glucose', 'Blood glucose increased']",UNK,PFIZER\BIONTECH, 1073585,,,M,"Caller took his fist vaccine 18Jan, he got tested positive 25 th; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A male patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller took his fist vaccine on 18Jan2021, he got tested positive on 25Jan2021, her mom died because of covid. Wants to know if he can take his 2nd dose on 08Feb2021, he's going to be out of quarantine before the 2nd dose. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 25Jan2021. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,01/25/2021,7.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1073586,,,F,"tested positive for Covid; tested positive for Covid; This is a spontaneous report via a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for covid on 2021. The outcome of the event was unknown. No follow-up attempts are possible; information about batch/ lot number cannot be obtained. .",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1073587,CA,,U,"headache; fatigue; body aches; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache, fatigue, body aches and joint pain. The events lasted for 1 week. The patient recovered from all the events on an unspecified date. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Arthralgia', 'Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH, 1073588,NY,,M,"received the first vaccine on 20Jan2021 and on 23Jan2021, covid virus tested positive; This is a spontaneous report from a contactable consumer (patient's spouse) via a Pfizer-sponsored program, . A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the first vaccine on 20Jan2021 and on 23Jan2021, covid virus tested positive. He was scheduled for #2 covax on 08Feb2021 and was asking if he should get the vaccine. Outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/23/2021,3.0,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1073589,GA,,F,"testedCOVID-19 positive today; fever; flu; testedCOVID-19 positive today; This is a spontaneous report from a contactable consumer for her mother from a Pfizer-sponsored program. A female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced testedcovid-19 positive today on 02Feb2021, fever and flu on an unspecified date. Reported as ""HCP in-behalf of her mother who received our vaccine shot 2-weeks ago. Her mother suffered from fever and flu after receiving the 1st shot. Her mother did a rapid test, and tested COVID-19 positive today. The caller is worried and doesn't know how to deal with this. her mother is scheduled for the 2nd shot next week."" The patient underwent lab tests and procedures which included COVID-19: positive on 02Feb2021. The outcome of the events was unknown. No follow-up attempts are possible, information on batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,02/02/2021,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'Influenza', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1073590,PA,,F,"sore throat; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (reporting for herself) An unspecified age female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 18Jan2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced sore throat on an unspecified date. The outcome was unknown. Information on the lot/batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,,,UNK,,,,,,['Oropharyngeal pain'],1,PFIZER\BIONTECH, 1073591,CA,,F,"shingles; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 28Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on unspecified date at a single dose for covid-19 immunisation. The patient experienced shingles on 01Feb2021. Outcome of the event was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,02/01/2021,4.0,UNK,,,,,,['Herpes zoster'],2,PFIZER\BIONTECH, 1073592,IN,,F,"blood sugar has elevated; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's blood sugar has elevated on 2021. Outcome of the event was unknown. Information regarding batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,,,UNK,,,,,,"['Blood glucose', 'Blood glucose increased']",1,PFIZER\BIONTECH, 1073593,MA,59.0,F,"right ear was aching; head was ache; jaw was also aching/throbbing; swelling of bottom lip and it was hot/bottom of the lip (underneath) was swollen; felt sick similar to a sinus infection/pressure in front of head, jaw, right ear/sinus pressure/pressure in nose/bad sinus infection in whole head/bad sinuses/took an antibiotic for sinus and pressure; dizzy on and off/Dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 19Jan2021 at a single dose for COVID-19 immunization. Medical history included sinus problems, allergy, allergy to cow's milk, TMJ (she had her wisdom teeth she was having issues on the right side; after they pulled it out she was fine), and wisdom teeth pulled out at the age of 57 or 58. Concomitant medication included ascorbic acid, biotin, folic acid, iron, manganese, nicotinic acid, pantothenic acid, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM FRUITY CHEWABLES). The patient previously took keflex and was allergic to it. The patient received her first dose of COVID-19 vaccine on 19Jan2021. She was okay from Tuesday to Thursday. On Friday (22Jan2021), the patient reported to have felt sick similar to a sinus infection, there were pressure in front of head, jaw, and right ear and was dizzy on and off for a long period. She had a sinus pressure/pressure in her nose and felt like she had a bad sinus infection in whole head. She is not saying she had a sinus infection, but that's what she experienced after receiving the shot. Her right ear was aching, head was ache, and jaw was also aching/throbbing on unspecified dates. The patient mentioned that she had swelling of bottom lip and it was hot/bottom of the lip (underneath) was swollen on 07Feb2021 but it went away today (08Feb2021). It was actually her neighbor that noticed the swelling and said it was on the bottom of lip chin area, it also felt hard when touching it. She called her primary care doctor following the events. At first, she did not want to provide these to her primary care, she did not have high blood pressure, high cholesterol or anything, but she did have bad sinuses. She took an antibiotic for sinus and pressure and her doctor told her that these could be side effects of the COVID vaccine as it causes dizziness and pressure. The dizziness must have been from the pressure since it was in her ear, cheek bones, and right ear was throbbing. It took her one month to come back to her normal self. The patient is scheduled to receive the next shot on 09Feb2021 and asked if she need to get the next shot or should she wait another week. The patient recovered from events ""felt sick similar to a sinus infection/pressure in front of head, jaw, and right ear/sinus pressure/pressure in her nose/bad sinus infection in whole head/bad sinuses/took an antibiotic for sinus and pressure"" and dizzy on and off/dizziness on 06Feb2021; recovered from event swelling of bottom lip on 08Feb2021; while unknown outcome for the remaining events. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/22/2021,3.0,UNK,CENTRUM FRUITY CHEWABLES,,Medical History/Concurrent Conditions: Allergy; Allergy to cow's milk; Sinus disorder; TMJ syndrome (she had her wisdom teeth she was having issues on the right side); Wisdom teeth removal (at the age of 57 or 58),,,"['Dizziness', 'Ear pain', 'Headache', 'Lip swelling', 'Pain in jaw', 'Sinusitis']",1,PFIZER\BIONTECH, 1073594,NY,68.0,M,"soreness at the injection site; twinge pain near his neck area; 100.4(Degree)F fever; chilled/shivering; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 08Feb2021 (reported as ""yesterday morning"", at the age of 68-year-old male) at single dose for covid-19 immunisation. Medical history included ongoing arthritis, he also took 2 Tylenol for his conditions (arthritis) around 2:30 pm. The patient's concomitant medications were not reported. First the patient had no problem, but last night at 11:00 PM he woke up very chilled, shivering, these symptoms lasted for 30 minutes and the went away. Today he's feeling a light soreness at the injection site, it's not aching, he also had a quick slight twinge pain near his neck area, however his lymph nodes are not swollen. He has taken his temperature 3 times today, the last one was 100.4(degree)F; he also took 2 Tylenol for his conditions (arthritis) around 2:30pm. He would like to know if fever is one of the side effect how concerned should he be and what should he do. He would like to know if this is something temporary. He has some questions about the risk of receiving the vaccine. He took the first dosage yesterday morning (on 08Feb2021) and then when he came home, he noticed around 11pm, he woke up and noticed he could not get comfortable. He had chills and that lasted for 30 minutes. Today, he noticed he has been taking his temperature. The last time he took it, it was 100.4 degrees. He has had slight soreness at injection site, not where some people he knows complained about pain all night long. He just has slight soreness. He did not have any information to provide on the other people that had pain all night long. He did not have any redness or swelling. He also read about lymph node swelling. He has a twinge of swelling in his neck and is not sure that is what it is. His fever has not subsided. He took Tylenol, which he later stated was an over the counter generic Acetaminophen, and he still has a fever. The outcome of the event Chills was recovered on 08Feb2021 23:30; of the other events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/08/2021,02/08/2021,0.0,UNK,,Arthritis (he also took 2 Tylenol for his conditions (arthritis) around 2:30pm),,,,"['Body temperature', 'Chills', 'Neck pain', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1073595,MD,66.0,F,"Cough; Chills; he came home and said he felt like crap, really bad, she said she did too; they are both so fatigued, so tired/exhausted; sore throat; major headache; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. This consumer reported similar events for two patients. This is the first of two reports. A 66-year-old female patient (wife) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EN5318), via an unspecified route of administration on 27Jan2021 13:00 at single dose on the left upper arm for COVID-19 immunization, reported as ""doesn't want to get the COVID"". There were no medical history and concomitant medications. The reporter said that she and her husband got first dose of COVID vaccine last week (27Jan2021) and they both got sick, had a major headache in Jan2021, cough and chills both on 27Jan2021, and also she wanted to know if she and her husband can take the second dose, scheduled on 17Feb2021. Patient stated that major headache went in on a ""Wednesday"". Her husband and her did, and went through vaccination portal, to get an appointment, appointments were very trying, as they were to do all healthcare providers first, which is understandable, and then the vaccine. They were trying to make it available for teachers, as they are going back to school, in school learning in March, so all teachers were the next step and then also anyone over 65 was able to go on the portal with the state to get an appointment to go and get a vaccination. She and husband have a daughter who was a teacher, and she said to go on the portal to get the shot, and they said they didn't have access to it, so she went on the site, and they got it in on 27Jan2021. The headache occurred after the 27Jan2021. Patient stated that as soon as they got home, her husband works full time, she lost her job in October, and she was home and he said ""how are you feeling"", he went back to work, patient came home and said she felt alright except for her arm then she got a really bad headache. The husband came home and said he felt like crap, really bad, patient said she did too, she was the type of person she never ever gets sick and if he was sick she does not say she was sick. Patient had such a bad headache, she thought her brain was ready to jump out of her head. Headache subsided after two days. She has recovered completely from the headache. Cough started almost immediately (27Jan2021), but patient did not cough today, but did last night, it was usually a deep cough. Today she has not coughed at all. Chills started probably that evening (27Jan2021), when she came home, the shot was around 1PM and chills started in the evening, and went away probably, they had gone back and forth for around two days but they were gone, she has recovered completely. Patient wished to add that they were both so fatigued, so tired, almost like, both she and her husband were very active, when they were down for the count, really exhausted, after this whole vaccination experience, both of them have been exhausted, to the point of going to bed at 8, and they were not 8:00 going to bed people. she doesn't want to be a pain, as she knows people have legit concerns, Patient doesn't want to waste time, her main concern is the second vaccination, if she does not have to, or is suggested to not take it, or her husband, she doesn't want the second vaccination to cause more severe side effects. The patient further reported, that they both experienced major side effects: chills, headaches, sore throat, major cough, fatigue that was ""just unbelievable, both of us are exhausted."" Her second dose is scheduled on 17Feb2021 and his husband is scheduled on 20Feb2021. Patient was asking ""if this was after the first dose, what's going to happen after the second dose?"". Outcome of the events headache and chills was recovered in 2021 for cough was recovered on 02Feb2021 while for other events was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021105012 same reporter/drug, similar events, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Cough', 'Fatigue', 'Feeling abnormal', 'Headache', 'Oropharyngeal pain']",1,PFIZER\BIONTECH, 1073596,LA,76.0,F,"not feeling good; chills; fever, which she thought was a 100.1; headache; nausea; started throwing up; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3246, NDC/UPC number and expiry date were unknown), via an unspecified route of administration on 31Jan2021 at a single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown) on an unspecified date for COVID-19 immunization. Relevant medical history included heart problem, for which the patient did take ""medicine,"" but it was not specified. All day on 01Feb2021, the patient was not feeling good; she had chills all day and then she had a fever, which she thought was a 100.1; and she had a headache; she had nausea and she started throwing up. The patient did not receive any treatment for the events. The outcome of all the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/31/2021,02/01/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Heart disorder,,,"['Body temperature', 'Chills', 'Headache', 'Malaise', 'Nausea', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH, 1073597,FL,74.0,F,"pain in her arm; tired; feeling unwell; This is a spontaneous report from a contactable nurse (patient). A 74 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration (on left arm) on 27Jan2021 13:30 (at the age of 74-years-old), single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the vaccine last Wednesday. Since then she has had pain on her arm mostly on the upper side of the arm. She took Tylenol and it went away. Adds she felt so tired and generally unwell, like the flu. Mentions it is like muscle pain in her left arm that come back whenever she moves around. All of this started on Wednesday. Adds it is not that severe, like if you have the flu. Mentions she does get muscle pain sometimes when she is working around the house but this is different. She is scheduled for the second dose of the vaccine 17Feb2021. She is starting to get worried about taking the second dose of the vaccine if it is going to be like this and wants to ask about that. She received the first dose of the vaccine on 27Jan2021 at 13:30PM in the left arm. That night, Wednesday night she noticed the pain in her upper arm. She took Tylenol and then the morning it went away. Friday it came back and she took Tylenol again and it went away. But when she works or walks around there is pain again. Seriousness not provided. The event pain in her arm was assessed as recovering, other events recovered on 31Jan2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,UNK,,,,,,"['Fatigue', 'Malaise', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1073598,SC,69.0,F,"She said she has a run of pain that pops up here, and there, and everywhere/pain going down her body; Headache; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264; expiry date: unknown) intramuscular in the left arm, on 01Feb2021 between 16:00-16:30, at a single dose, for COVID-19 immunization. Medical History included Right-sided Breast Cancer over 30 years ago. No lymph nodes were involved, so she didn't need chemotherapy or radiation. She had breast reconstruction and right mastectomy performed. She also had 2 hip replacements. Other medical history included nerve disorder and car accident. She has had bad nerves since she was 18 years old. She said she hasn't worked in over 30-something years because she worked so much to raise her kids by herself and send them to college. She said her psychiatrist and a doctor told her she had to stop working. She walks 5 miles every day and has no underlying conditions. Concomitant medications included an unspecified nighttime medication for her nerves and pain medication because she was in a car accident. The patient previously received first dose of BNT162B2 (Lot Number: EK9231) in the left arm, on 11Jan2021 for COVID-19 immunization. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient did not have previous immunization with a Pfizer vaccine. No additional vaccines administered on same date of the Pfizer suspect. The vaccine was administered in a Field. The patient reported that she got her second Pfizer COVID-19 Vaccine dose on 01Feb2021. After she got the second COVID-19 vaccine shot she was okay for a while, then she had a little injection site pain immediately after receiving the COVID-19 vaccine injection. She said the injection site pain was gone, clarifying if she mashes the injection site, the injection site doesn't hurt. She was only able to have shots on her left arm because she had a right mastectomy, so she can't have anything on her right side. On 02Feb2021, the big boom hit, and it has been all day. She has been breathing well and has no temperature. On the same day (02Feb2021) the patient experienced run of pain that pops up here, and there, and everywhere. She had a headache, as well. She was concerned if should take anything for the pain. She does not want to do what is not right. She wanted to do things the way that Pfizer has suggested. She put heat around face, neck, and arms, but now the pain was going down her body. She has been microwaving rice in a bag and using the heated bagged rice to apply heat to her face, neck and arms. She had a physical recently with unknown results, but she had no recent blood work. The events did not require emergency or physician visit. Outcome of the event injection site pain was recovered on 02Feb2021, while for the other events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Accident automobile; Breast cancer (right-sided breast cancer over 30 years ago); Breast reconstruction; Hip replacement (2 hip replacements); Mastectomy; Neuropathy (bad nerves since she was 18 years old),,,"['Headache', 'Pain', 'Physical examination', 'Vaccination site pain']",2,PFIZER\BIONTECH,OT 1073599,,,F,"She is very sick; This is a spontaneous report from a contactable consumer. A female patient (reporter's mother) of an unspecified age (Age: 84; Unit: Unknown) received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated ""we had that COVID test (unknown results), the COVID Vaccine on Sunday and my mother, I am calling for my mother and she is very sick (onset date not reported) and we don't know if we need to go to the emergency room or what."" Reporter further stated, ""we talked to our doctor and he said take her to the emergency room and just get her checked out. She is 84."" The outcome of event was unknown. Information about Lot and Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Malaise', 'SARS-CoV-2 antibody test']",UNK,PFIZER\BIONTECH, 1073600,,,U,"Chills; Ache; Slight fever/I had slight fever 99.7; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 01Feb2021 17:00 (reported as 5 PM) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the vaccine last night at 5 PM on 01Feb2021 and woke up on 02Feb2021 (morning) at 5 AM with chills, ache with no fever at that time but as the morning ahead, patient had slight fever 99.7. Patient read in the paper that those are very common side effects. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/02/2021,1.0,PHM,,,,,,"['Body temperature', 'Chills', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1073601,CA,,M,"severe headache; got cold; Chills; pain in the back of his waist; swelling face (having some swelling as his face was looking puffy); This is a spontaneous report from two contactable consumers. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 01Feb2021 17:30 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient experienced severe headache, got cold, had chills, pain in the back of his waist and swelling face (having some swelling as his face was looking puffy) on unspecified date in Feb2021. Therapeutic measures were taken which included taken 2 diphenhydramine hydrochloride, paracetamol (TYLENOL PM); however, symptoms were still there. If someone could alleviate the pain the patient would appreciate it as reported. Reporter stated that patient was going to go ahead now to emergency room and to seek medical attention now. Outcome of the events was not recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,UNK,,,,,,"['Chills', 'Headache', 'Nasopharyngitis', 'Pain', 'Swelling face']",UNK,PFIZER\BIONTECH, 1073602,MN,42.0,M,"soreness at the point of administration of his left arm; Muscle soreness/muscle soreness at the point of injection spread to his whole body; it was like aches all over his body; Fatigue; Frequent urination; Cognitive fuzziness; This is a spontaneous report from a contactable consumer (patient) reported that a 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date 31May2021), intramuscular on the left arm on 28Jan2021 16:15 at a single dose for Covid-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), mentioned he was a patient facing drug addiction counselor in training, smoke cigarettes but he has cut down to a half a pack a day, at most. The patient previously received flu vaccine on an unspecified date for flu vaccination and experienced soreness at the point of administration of his left arm. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken from an unspecified date for ADHD. The patient received his first COVID-19 vaccine this past Thursday, 28Jan2021. The next morning (29Jan2021), he woke up with real soreness at the point of administration of his left arm, well beyond what he remembered for a flu vaccine. The second night (30Jan2021), the soreness progressed. It was hard to sleep on his left arm. It was like he had been punched. He had to sleep on his right side versus his left side. On 29Jan2021, the muscle soreness at the point of injection spread to his whole body, it was like aches all over his body. The soreness has gotten a little bit better day by day. He confirmed he got a rapid nasal molecular COVID swab test because he was just covering his bases and he tested negative for COVID-19 on 02Feb2021. He also experienced fatigue. The fatigue really started to set in on Friday evening (29Jan2021), it was like he got hit by a truck. He was typically a high energy person and its very out of the ordinary for him to feel this way. He normally has class on Saturday from 9-noon but he had to cancel going with the amount of fatigue he was experiencing. He also had some cognitive fuzziness on Jan2021. His fatigue was still there, but it has gotten a little better. He was normally very high energy, but he missed two classes and skipped his internship today. He doesn't feel like himself. He also has had frequent urination which he noticed probably Friday night (29Jan2021), all the way up until now. However, he has been drinking a lot of water. The patient received a test/report showing he has no chromosomal issues and no likelihood of issues on an unspecified date. The outcome of soreness at the point of administration of his left arm and Frequent urination was not recovered; Muscle soreness/muscle soreness at the point of injection spread to his whole body and fatigue was recovering; it was like aches all over his body and cognitive fuzziness was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/01/2021,,UNK,ADDERALL,,"Medical History/Concurrent Conditions: ADHD; Drug addiction (Caller mentions he is a patient facing drug addiction counselor in training.); Smoker (He does smoke cigarettes but he has cut down to a half a pack a day, at most.)",,,"['Fatigue', 'Investigation', 'Myalgia', 'Pain', 'Pollakiuria', 'SARS-CoV-2 test', 'Thinking abnormal', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 1073603,,,F,"the side effects just other than and pain and stiffness in the arm; the side effects just other than and pain and stiffness in the arm; Chills; fatigue and tiredness; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported similar events for two patients. This is the second of 2 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01Feb2021, four days after vaccination, it was reported that the patient experienced chills, fatigue and tiredness and it better overnight. It was also reported that the reporter want know the side effects just other than pain and stiffness in the arm after four days which started on an unspecified date. The outcome of the events chills, fatigue and tiredness was recovered overnight on 02Feb2021 while for the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021147760 same reporter, suspect vaccine, events; different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,02/01/2021,4.0,UNK,,,,,,"['Chills', 'Fatigue', 'Musculoskeletal stiffness', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 1073604,,,M,"Chills; Tiredness; Ache; pain and stiffness in the arm; pain and stiffness in the arm; This is a spontaneous report from a contactable other healthcare professional (patient). This healthcare professional reported similar events for two patients. This is the first of 2 reports. A male patient of an unspecified age (reported 84, unit unknown) received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 28Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced pain and stiffness in the arm, chills, tiredness and ache even 4 days later after vaccination. The patient would like to know if it is normal to get side effects from the covid vaccine up to 4 days later. The outcome of event pain and stiffness in the arm was unknown; all other events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021147698 same reporter, suspect vaccine, events; different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/01/2021,4.0,UNK,,,,,,"['Chills', 'Fatigue', 'Musculoskeletal stiffness', 'Pain', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 1073605,,,M,"first shot of Pfizer Covid vaccine two and half weeks ago on Jan2021 but now he is positive with Covid; first shot of Pfizer Covid vaccine two and half weeks ago on Jan2021 but now he is positive with Covid; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was diagnosed on 02Feb2021 with COVID. He tested positive and had his first shot of Pfizer Covid vaccine two and half weeks ago on Jan2021 but now he is positive with Covid. He was definitely quarantined for 10 days but (incomplete sentence). Reporter was asking why did he get sick after getting the first shot. Outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,02/02/2021,32.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1073606,MO,46.0,F,"4 hours post injection I experienced a significant drop in blood sugar; This is a spontaneous report from a contactable other hcp (reporting for herself). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN 5318), via an unspecified route of administration right arm single dose on 27Jan2021 12:00 (at the age of 46) for covid-19 immunisation. No other vaccine was received in four weeks. Medical history included type 2 diabetes mellitus, rhinitis allergic, myalgia, dairy intolerance. Concomitant medications included metformin, insulin degludec, liraglutide (XULTOPHY), lisinopril, rosuvastatin. The patient experienced (4 hours and 45 min post injection) a significant drop in blood sugar on 27Jan2021 16:45. The patient underwent lab tests and procedures which included blood glucose from 112 (mid-day value) to 73 on 27Jan2021. Patient did not require medical attention and was able to manage the drop with juice. No other issues nor problems occurred related to this change in blood sugar. The outcome was recovered",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,WRK,METFORMIN; XULTOPHY; LISINOPRIL; ROSUVASTATIN,,Medical History/Concurrent Conditions: Allergic rhinitis; Dairy intolerance; Myalgia; Type II diabetes mellitus,,,"['Blood glucose', 'Blood glucose decreased']",1,PFIZER\BIONTECH, 1073607,,64.0,F,"skin is burning up, her arms, her face, her stomach, her back, and her chest are burning up/burning skin has probably gotten worse; Nausea; no appetite; Headache; bad sore throat; felt sick since she got it; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EL9262), via an unspecified route of administration on left arm (at the age of 64 years) on 24Jan2021 at single dose for covid-19 immunization. Medical history included type 2 diabetes (borderline about 15 years ago/started taking a medication a year ago for her high sugar numbers/had some blood tests, her A1C was normal, her diabetes was the same way it always has been); hypertension from 2012 (diagnosed about 9 years ago); sleep apnea from 2020 (uses a C-PAP machine/diagnosed approximately a year ago); Epstein Barr from 1995 (diagnosed when she was 39); high cholesterol (sometimes she didn't take her medication for that); cataract and cataract surgery in Jan2021 (had this last month/they used anesthesia/didn't know which type/had some eye drops for this). Concomitant medication included an unspecified high blood pressure medication (she thinks she tried a few times). The patient called about Pfizer COVID-19 vaccine and she had questions and side effects. She did get one shot, and was not due for her second for a couple weeks. The patient felt sick since she got it, some side effects have been less, some stayed the same or got worse. Her skin was burning up, her arms, her face, her stomach, her back, and her chest were burning up. She has done no treatment, because she didn't know what to do to treat it and it was difficult to be able to get in to see a doctor. The burning skin has probably gotten worse. She also had nausea and no appetite, though she has gotten a little better, it has been at least a full week or so. She had a headache and a bad sore throat also. She got home from getting the shot, probably maybe 5 or 6 hours after getting the shot. The patient's weight was 145-150lbs. The outcome of the event skin burning sensation was not recovered while for the remaining events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Cataract; Cataract operation (had this last month/they used anesthesia/didn't know which type/had some eye drops for this); CPAP; Epstein-Barr virus infection (diagnosed when she was 39); High cholesterol (sometimes she didn't take her medication for that); Hypertension (diagnosed about 9 years ago); Sleep apnea (uses a C-PAP machine/diagnosed approximately a year ago); Type 2 diabetes mellitus (borderline about 15 years ago/started taking a medication a year ago for her high sugar numbers),,,"['Decreased appetite', 'Glycosylated haemoglobin', 'Headache', 'Malaise', 'Nausea', 'Oropharyngeal pain', 'Skin burning sensation', 'Weight']",1,PFIZER\BIONTECH, 1073608,WI,72.0,F,"aches; itching; kind of tired; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262, expiry date unknown) in the doctor's office, via an unspecified route of administration on 27Jan2021 at a single dose on the right arm as she was over 65, for COVID-19 immunization. Medical history included ongoing diabetes mellitus a long time ago since she was in her 60's, ongoing blood pressure, ongoing high cholesterol and cyst. Concomitant medication included ongoing losartan (manufacturer unknown) for blood pressure, ongoing pravastatin (manufacturer unknown) for high cholesterol, metformin (manufacturer unknown) for diabetes mellitus from an unspecified date to an unspecified date and ongoing sitagliptin (JANUVIA) for diabetes mellitus. The patient was also prescribed an unspecified antibiotic for a cyst which was taken 2 weeks before the vaccination. The patient did not have prior vaccinations within 4 weeks of the COVID vaccine. The patient experienced itching on 27Jan2021, the same day as the Covid 19 shot later in the day, after she got home. She didn't pay attention to it. The next evening she called her doctor and told him about it and he said it was one of the side effects of the Covid 19 shot and prescribed Benadryl. She started the Benadryl that same night, 28Jan2021. She should not have waited, she should have called the doctor the same day. She called the pharmacy and got the prescription, it's not that far for her. The patient stated that the the itching lasted a couple of days, it is gone, as of an unspecified date. She took Benadryl for the itching, it is the best thing for her. In all, she thinks she went through 2 to 3 days of the whole situation. The patient also stated that she took Tylenol for the aches and that got better. She had aches but the aches from the Covid 19 shot started on 28Jan2021. On the day of the report, she was a lot better. The aches went away but does not recall what day they went away. She feels much better that day. The aches were not severe. She added that the aches and itching lasted for 2-3 days and are totally improved, that they stopped on an unspecified date. State she was able to go outside that day. She added that she was kind of tired. She had to lay down one day because the itching and aches were bad. The outcome of the event kind of tired was recovering while the outcome of the other events was recovered on an unspecified date in 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/01/2021,,PVT,LOSARTAN; PRAVASTATIN; METFORMIN; JANUVIA [SITAGLIPTIN],Blood pressure high; Diabetic (diagnosed a long time ago and has had since she was in her 60's.); Hypercholesterolemia,Medical History/Concurrent Conditions: Cyst,,,"['Fatigue', 'Pain', 'Pruritus']",1,PFIZER\BIONTECH, 1073609,CO,90.0,M,"sore and aching all over; soreness is down in his abdominal area; soreness is down in his abdominal area and the base of his spine; This is a spontaneous report from a contactable consumer (patient). A 90-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL5318), via an unspecified route of administration in left arm on 31Jan2021 12:30 at single dose for COVID-19 immunization. Medical history included blood thinner (doctor basically wants to thin his blood due to his age and so forth) from an unknown date and unknown if ongoing, the patient mentioned this to his doctor did want him taking the baby aspirin every day of the week but he told his doctor he bled too much and his doctor ""well oh okay"". Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) as blood thinner, lisinopril, metoprolol succinate and amlodipine besilate. The patient previously took flu vaccine. The patient received his COVID vaccination around 12:30 Sunday afternoon. He felt fine for the next 2 hours and then he started feeling a little sore and so forth. By evening, the patient was sore and aching all over on 31Jan2021. This is the only side effect he had, everything else went fine. He could hardly get out of bed yesterday because he was so sore all over and it was the same today. The patient stated, ""I keep shrinking at this age"". The patient found that when he gets out of bed and forces himself to walk around very carefully, it seems to get a little better. Today, the soreness was down in his abdominal area and the base of his spine. The rest has seemed to clear up. The patient confirmed it has improved some. The doctor did a blood test about two weeks ago prior to the vaccine and it came back excellent in Jan2021. The patient wants to know if it is okay to take Advil or something like that to reduce the pain. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,01/31/2021,0.0,OTH,BABY ASPIRIN; LISINOPRIL; METOPROLOL SUCCINATE; AMLODIPINE BESILATE,,Medical History/Concurrent Conditions: Blood disorder,,,"['Abdominal pain', 'Blood test', 'Pain', 'Spinal pain']",1,PFIZER\BIONTECH, 1073610,,,F,"tested positive for COVID; tested positive for COVID; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for Covid on an unspecified date. The patient wants to know if it is recommend for a person to get the second dose if they have tested positive for COVID. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1073611,WI,81.0,F,"She went to the living room and fell and couldn't get up; She went to the living room and fell and couldn't get up; tiredness; She has a sore throat and fever blisters on her mouth; lost almost 18 pounds in the last week with all this stuff; severe headache; muscle pain in the back of her neck and back; She has a sore throat and fever blisters on her mouth; violent chills; sick with diarrhea; Dry heaves; This is a spontaneous report from a contactable Consumer. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date not reported) via an unspecified route of administration to left arm on 25Jan2021 at single dose for covid-19 immunization. Medical history included Crohn's disease and Type II Diabetes. The patient experienced sick with diarrhea on Jan2021, dry heaves on Jan2021, she went to the living room and fell and couldn't get up on 27Jan2021, tiredness on Jan2021, she has a sore throat and fever blisters on her mouth on Jan2021, lost almost 18 pounds in the last week with all this stuff on Jan2021, severe headache on Jan2021, muscle pain in the back of her neck and back on Jan2021, violent chills on Jan2021. The patient underwent lab tests and procedures which included weight: lost almost 18 lbs on an unspecified date (lost almost 18 pounds in the last week with all this stuff). She received the first dose of the vaccine a week ago on Monday. For two days she was absolutely normal and fine. The night of the second day she had fallen asleep on the couch and when she woke up it was midnight. She knew immediately she was going to be sick with diarrhea. She had dry heaves. She never vomited. The dry heaves were longer than she has had in her life. The diarrhea kept going and going. She went to the living room and fell and couldn't get up. She is 80 years old (as reported). She has never had that happen before. She slept on the floor until six in the morning. When she woke up she managed to get up. She had so many of these side effects. She has tiredness, severe headache, muscle pain in the back of her neck and back, violent chills. She has never had chills so violent before. She has a sore throat and fever blisters on her mouth. There must be 9 or 10 of them. It is a never ending list. She has lost almost 18 pounds in the last week with all this stuff. The symptoms have not stopped. Outcome of the events was not recovered",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Crohn's disease; Type II diabetes mellitus,,,"['Chills', 'Diarrhoea', 'Fall', 'Fatigue', 'Headache', 'Loss of personal independence in daily activities', 'Myalgia', 'Oral mucosal blistering', 'Oropharyngeal pain', 'Retching', 'Weight', 'Weight decreased']",1,PFIZER\BIONTECH, 1073612,,,F,"localized extreme reaction for her arm; deltoid is very sore, she is in pain; numbness, tingling radiating all the way down to her hand; numbness, tingling radiating all the way down to her hand; her arm is now severely in pain; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received bnt162b2 (Covid vaccine) via an unspecified route of administration in arm (deltoid) on 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is a 42 years old dentist who had Pfizer vaccine on 04Jan2021, she had extreme reaction just localized extreme reaction for her arm, her deltoid is very sore, she is in pain, numbness, tingling radiating all the way down to her hand on unspecified dates. The concern is should she get another Covid vaccine, she is already past the window to get it and she is still having extreme arm pain raiding down her hand and so the question is the patient thinks she needs to get the second vaccine and the reporter is not so sure that's a good idea and she is still having this reactions so she reported this to the VAERS system but the reporter just wanted to know how to treat her. The patient was given two rounds of steroids as treatment, both have helped which means better but now she is worse again her arm is now severely in pain. The reporter talked to an orthopedic surgeon who wasn't sure about giving her an injection into the shoulders because she will probably get the vaccine again. The patient had not recovered from the events. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/04/2021,,,UNK,,,,,,"['Hypoaesthesia', 'Pain in extremity', 'Paraesthesia', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 1073613,CA,68.0,F,"chills; very fatigued; sore arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) solution for injection, via an unspecified route of administration on left arm on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient got her second shot of COVID vaccine yesterday, 01Feb2021, and was asking if she was infectious to anyone. She had some chills, was very fatigued and was a having sore arm. The sore arm started last night (01Feb2021) and when she woke up this morning (02Feb2021), she was with the chills and fatigue. The patient stated that they could be related to the fact that she got up at about 3:00 in the morning. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Fatigue', 'Pain in extremity']",2,PFIZER\BIONTECH, 1073614,,68.0,F,"right arm that she received the shot in has gone to sleep; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EN9581), via an unspecified route of administration on right arm on 02Feb2021 at 14:00 (at the age of 68years) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient just had the first dose of the covid vaccine shot on 02Feb2021 at 14:00 and her right arm that she received the shot in has gone to sleep. The patient asked if this was something to be concerned about. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/02/2021,0.0,UNK,,,,,,['Injected limb mobility decreased'],1,PFIZER\BIONTECH, 1073615,MA,66.0,F,"Nausea; vomiting; This is a spontaneous report from a contactable consumer. A 66-year-old female patient, who was also 66-year-old at the time of vaccination, received first dose of bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from 01Feb2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Feb2021 02:00, patient experienced nausea and vomiting. The outcome of the events was recovered. The patient is not pregnant at the time of vaccination. No treatment was given for the events. The patient did not have COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/02/2021,1.0,UNK,,,,,,"['Nausea', 'Vomiting']",1,PFIZER\BIONTECH, 1073616,MD,28.0,F,"back of her left shoulder is very painful; soreness; weakness in left arm; horrible pain injection site; redness at the injection site for 3 days after; Stomach pain; Nausea; Headache; redness in left arm; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), on the left arm, intramuscularly on 25Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history included ongoing seasonal allergy diagnosed a couple of years ago, ongoing food allergy she has had allergies to tree nuts, peanuts, shellfish, and sesame seeds her whole life. Concomitant medications include an unspecified product. The patient previously received the first dose of BNT162B2 on 04Jan2021 at around 12:30-13:00, intramuscular injection in left arm Lot number: EL1284 for COVID-19 immunization and experienced soreness. The patient also reported to have received a flu shot on an unspecified date in 2019 and had soreness. The patient reported to have received the second dose Monday, 25Jan2021 at 14:00 and had redness in her arm which recovered completely on Thursday 28Jan2021. On Tuesday night, 26Jan2021, the patient was sick with stomach pain, nausea, and a bad headache that went away by Wednesday, 27Jan2021. She was less sore on Wednesday, 27Jan2021, and she worked out, she did yoga, she got horrible pain at the injection site which started on 28Jan2021, Thursday morning in the middle of the night and stopped by the end of the day. States it went away with pain medication. The pain is nothing like she experienced before. The vaccine site area has been a little sore. She did yoga again last night and the same thing happened, she got pain at the injection site that was horrible. Reports the back of her left shoulder is very painful, it is sharp pains that do not go away on unspecified date. Took some Tylenol for pain at the injection site and left shoulder, that didn't help, took Aleve, heat and ice and by the end of the day, patient was fine. Just some soreness until middle of the night again, same reaction as before. Reports she had redness at the injection site 3 days after on 28Jan2021. She forgot to mention that she had weakness in her left arm that started 28Jan2021 and then she was fine and the weakness started again today. The outcome of the events redness in her arm was recovered on 28Jan2021, sick with stomach pain, nausea, and a bad headache was recovered on 27Jan2021, pain at the injection site, back of her left shoulder is very painful, weakness in her left arm was not recovered, while for the rest of the events was unknown. The patient was vaccinated in a hospital.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,PVT,,"Food allergy (she has had allergies to tree nuts, peanuts, shellfish, and sesame seeds her whole life); Seasonal allergy (Verbatim: Seasonal allergy/diagnosed a couple of years ago)",,,,"['Abdominal pain upper', 'Arthralgia', 'Erythema', 'Headache', 'Muscular weakness', 'Nausea', 'Pain', 'Vaccination site erythema', 'Vaccination site pain']",2,PFIZER\BIONTECH,OT 1073617,WI,85.0,F,"a little bit of arm pain/Her arm was a little amount sore; This is a spontaneous report from a contactable consumer. An 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262), via an unspecified route of administration on 01Feb2021 09:45 at a single dose for COVID-19 immunization. Medical history included ongoing Splenic marginal cell non-Hodgkin's Lymphoma of the B cells and spleen; infection in her bursae sack in her knee and she was in the hospital for that; she also had three infections. There were no concomitant medications. The patient reported that the shot was so simple, and she hates shots. It was the Pfizer shot given by a nurse at the clinic. Before bed on 01Feb2021, she thought her arm was starting to hurt so she took a pain pill. She doesn't think she needed it. She got the vaccine at 09:45 in the morning of 01Feb2021. She thought she had arm pain, but she didn't really ever get it. She didn't experience pain or anything otherwise. She also stated that she had a little bit of arm pain, her arm was a little amount sore. But it went away by the next day on 02Feb2021. It was very minor. She didn't feel like it was worth reporting. She felt it once in a while if she moves her arm but is not enough to mention. She hates shots, and this one wasn't as bad as half of the other shots she has had. She has no complaint about it. The outcome of the event was recovered on 02Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,OTH,,Hodgkin's lymphoma; Splenic lymphoma,Medical History/Concurrent Conditions: Bursitis of knee; Hospitalization; Infection,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1073618,FL,74.0,F,"Swelling; Redness moved from actual site down my arm about 6 to 7 inches; Hot to touch area on right arm; A little headache at the back of the head; Itching; More pain when l lift my arm, my arm pits/Hurting under her arm when she was lifting; Swollen glands; My temperate was 100.8; had difficulty lifting her right arm; Tired, very tired; Tenderness at vaccinate site; More pain when l lift my arm, my arm pits/pain in arm/pain in her right arm/a lot of pain; I feel tugging and redness when I raise my arm, It's not red its blotchy; I feel tugging and redness when I raise my arm, It's not red its blotchy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscularly at site of right arm on 28Jan2021 at single dose for COVID-19 immunisation. Medical history included (synthroid: Taking for years), prevent urinary tract infection (UTI) (methenamine: started a year and a half ago), vitamin supplementation (Preservision Areds 2 eye vitamins more than a year ago; Vitamin C with Zinc 8-9 months ago), dry eyes (Thera tears: dry eye therapy. she has not been consistent with taking), cholesterol (simvastatin: taking 20 years or more), allergic to Sulfa Drugs and Tetracycline, obesity (had been fighting it for 30 years), removed polyps (had a flat polyp that was a little more dangerous the first time and it was removed; non-cancerous), got the flu (08Jun months later, got the flu, went to the hospital and developed PNA) and eczema (took calcium 1200mg). Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid; methenamine for prevent UTI; ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2) for vitamin supplementation; ascorbic acid, zinc (VITAMIN C WITH ZINC) for vitamin supplementation; carmellose sodium (THERA TEARS) for dry eyes; simvastatin for cholesterol; calcium for eczema. The patient previously took Flu vaccine (Injection site was left arm, intramuscularly) in Oct2018 and experienced pain in injection site and redness in arm; took the first dose of BNT162B2 with lot number: EL3246, intramuscularly in left arm site at 09:00 on 08Jan2021. Clinical course: After the second dose of vaccination, patient noticed tenderness at vaccinate site at 13:00 and had pain in arm on 28Jan2021, but on 29Jan2021, the pain was worse, and she had difficulty lifting her right arm at 16:00. On 30Jan2021, she started noticing more pain when she lifted her arm, her arm pits, it was hurting under arm when she was lifting. She thought maybe there were swollen glands but did not feel it. her temperate was 100.8, and she took some paracetamol (TYLENOL), by the evening, her temperature was at 98.6 normal. On 31Jan2021, she noticed a lot of pain, itching and redness, redness moved from actual site down her arm about 6 to 7 inches at 14:00. The pain in her right arm was not as bad as it was, but the redness in the area and itching was there, it was hot to touch area on right arm, and she tried cold compresses and took paracetamol. Also, it was hurting under her arm when she was lifting. She experienced something like that before with a Flu vaccine. She noticed when she looked it up, the information states, yes. And it was still going on today, not so much pain, just swelling and redness, looked like what Moderna calls a covid arm. She had no temperature, a little headache on 31Jan2021 at the back of the head and tired, very tired, she was tired from 29Jan2021, and was better from 01Feb2021. She took paracetamol last night, and cold compress. she used to take baby aspirin; she didn't know if it would be a problem. She read not to take paracetamol or ibuprofen before vaccination. She felt tugging and redness when she raised her arm, it was not red its blotchy. She didn' t feel any swelling. The last 7 to 8 months, she was running high blood counts, 12.3 (high) and she had no infection, her doctor was a little nervous, the last one on 15Jan2021, it was down to 10.2 within normal range. Her immune system was very active. She had a flu shot in Oct2018 at age of 72 y/o and by 08Jun months later, she got the flu. She went to the hospital and developed PNA. In 2019 and again this past Aug2020, she had a Colonoscopy where they removed polyps. She had a flat polyp that was a little more dangerous the first time and it was removed. It was non-cancerous. The doctor was just watching it. Last blood results were 2 weeks prior to having first shot on 15Jan2021. The only thing that showed was her Liver enzymes were a little elevated. She was told that if she hadn't gotten the vaccine, it would have been worse, her doctor gave me the zpack. They were calling it a subcutaneous sensitivity, she had eczema, she forgot to mention that. She was taking calcium 1200mg, she forgot to tell her that also. The outcome of events pain in arm, redness and feeling hot was not recovered; of events tiredness, body temperature increased, itching and headache was recovering; of rest events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/01/2021,,PVT,SYNTHROID; METHENAMINE; PRESERVISION AREDS 2; VITAMIN C WITH ZINC; THERA TEARS; SIMVASTATIN; CALCIUM,,"Medical History/Concurrent Conditions: Blood cholesterol abnormal (Simvastatin: Taking 20 years or more); Drug allergy; Dry eyes (Thera Tears: Dry eye therapy. She has not been consistent with taking); Eczema (took calcium 1200mg.); Flu (08Jun months later, got the flu, went to the hospital and developed PNA.); Obesity (had been fighting it for 30 years); Polyp removal (had a flat polyp that was a little more dangerous the first time and it was removed; non cancerous); Thyroid disorder (Synthroid: Taking for years); UTI (Methenamine: Started a year and a half ago); Vitamin supplementation (Preservision Areds 2 eye vitamins more than a year ago; Vitamin C with Zinc 8-9 months ago)",,,"['Axillary pain', 'Body temperature increased', 'Body temperature normal', 'Colonoscopy', 'Erythema', 'Fatigue', 'Feeling abnormal', 'Feeling hot', 'Headache', 'Joint range of motion decreased', 'Liver function test', 'Lymphadenopathy', 'Pain in extremity', 'Pruritus', 'Rash macular', 'Swelling', 'Vaccination site pain', 'White blood cell count']",2,PFIZER\BIONTECH,OT 1073619,NY,,M,"Muscle pain; Joint pain; isn't feeling very well; burning and sharp pain; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the COVID 19 vaccine (Pfizer shot) last Monday (unspecified date). He was having some side effects including muscle pain, joint pain, and burning and sharp pain. He wanted to get a little information about that. He is scheduled for the second dose on 13Feb2021. The patient mentioned that this whole week, he has been going through this pain. The patient isn't feeling very well, and he doesn't want to stay on the phone. He doesn't want to report at this time. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Arthralgia', 'Malaise', 'Myalgia', 'Pain']",1,PFIZER\BIONTECH, 1073620,MT,73.0,F,"She has immune issues and stress/ methylprednisolone for immune issues; She has immune issues and stress/ methylprednisolone for immune issues; severe headache/ pain in the base of her skull; nausea; vomiting; had pain at the top of her spine where the spine meets the skull; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (BNT162B2, lot number: EL9264) via an unspecified route of administration, on 01Feb2021 12:45PM at a single dose on top of left arm for COVID-19 immunization. The vaccine was given at a Clinic which is an off shoot of the hospital. The patient did not receive any vaccinations within 4 weeks prior to receiving BNT162B2. Medical history included Wegner's disease, immune issues and stress. She stated that there would be one doctor providing medication for stress and other doctor providing other medications. She has immune issues and stress. Concomitant medications included buspirone from an unspecified date and ongoing (been on it for quite a few years), clonazepam from an unspecified date and ongoing (been on it for quite a few years), fluticasone propionate (FLOVENT) from an unspecified date and ongoing (been on it a little over a year or two and it was prescribed by her pulmonologist), hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) from an unspecified date and ongoing (has been on it for more than 5 years and was prescribed by her primary care), methylprednisolone for immune issues, bupropion hydrochloride (WELLBUTRIN), and nebulizer for saline for Wegner's disease (It is prescribed by her ear, nose, and throat doctor). The patient previously received a flu shot in 2020 and experienced sore arm and achy feeling. On 01Feb2021 18:45, the patient experienced severe headache, nausea, vomiting, and pain in the base of her skull. A lot of people thought it was throwing her into a migraine. She has never had a migraine in her life. It was awful and pretty extreme. Severe headache, nausea, vomiting, and pain in the base of her skull started about six hours after the shot (at 18:45) and proceed a good 24 hours later. She also had pain at the top of her spine where the spine meets the skull. She would say that the symptoms stopped on 02Feb2021. She has recovered almost completely. She is still not quite completely 100 percent. The reported adverse events did not require a visit to emergency room or physician office. Some relatives said she should have gone in, but she did not. Outcome of the events was recovered on 02Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,OTH,BUSPIRONE; CLONAZEPAM; FLOVENT; TRIAMTERENE AND HYDROCHLOROTHIAZIDE; METHYLPREDNISOLONE; WELLBUTRIN,,Medical History/Concurrent Conditions: Immune system disorder; Stress; Wegner's disease,,,"['Headache', 'Nausea', 'Off label use', 'Product use issue', 'Spinal pain', 'Vomiting']",UNK,PFIZER\BIONTECH, 1073621,LA,68.0,M,"Headache; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261), intramuscular in the right arm on 31Jan2021 16:15 at a single dose for COVID-19 immunisation. The patient's medical history included ongoing blood pressure high diagnosed at least 10 years or more, ongoing chronic back pain. There were no concomitant medications. On 31Jan2021 18:15, the patient experienced headache. The only thing he had was a little small headache. Outcome of the event was recovered on 01Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/31/2021,01/31/2021,0.0,PVT,,Blood pressure high (Diagnosed at least 10 years or more.); Chronic back pain,,,,['Headache'],1,PFIZER\BIONTECH,OT 1073622,FL,75.0,M,"Fever; Stomach upset; Chills; A little bit of body aches; Headache; We both had sore arms; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration at the age of 75 years, on 01Feb2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included myocardial infarction from an unknown date and unknown if ongoing. The caller stated, ""Heart attack about 12 or 13 years ago."" The patient also had a stent placement from an unknown date and unknown if ongoing. It was stated, ""He has three stents in his arteries"". Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), metoprolol (METOPROLOL) and rosuvastatin (ROSUVASTATIN). The patient received first dose of COVID vaccine BNT162B2 at the age of 75 years on Jan2021 at a single dose for COVID-19 immunization. The patient's wife stated, ""My husband and I, both got our second shot of Pfizer COVID Vaccine yesterday. Just late this afternoon (02Feb2021), he had a fever of 101.5 which has come down now because he took some Tylenol, had a stomach upset and chills and a little bit of body aches and headaches. Is this the normal reaction that has been with the Pfizer Vaccine?"" It was stated, ""I think he is feeling a lot better. He took two Tylenol and his fever has gone down to 98.7."" It was further stated, ""I have a sore arm and it is much better today but it is still just little tender that is the only thing I had. His arm was pretty sore yesterday as well."" The wife stated, ""Yesterday, just shortly after we both got the shot. We both had sore arms by the time we drove home, yesterday afternoon, 1Feb2021. My arm is slightly stiff still, just the muscle is slightly sore and I think, my husband is feeling a lot better today too, just slightly sore."" The patient underwent lab tests and procedures which included body temperature: 101.5 on 02Feb2021 and body temperature: 98.7 on Feb2021. Therapeutic measures were taken as a result of fever (pyrexia). The outcome of the events was unknown. Information on lot number/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/02/2021,1.0,UNK,BABY ASPIRIN; METOPROLOL; ROSUVASTATIN,,"Medical History/Concurrent Conditions: Heart attack (Caller stated, ""Heart attack about 12 or 13 years ago.""); Stent placement (Caller stated, ""He has three stents in his arteries."")",,,"['Abdominal discomfort', 'Body temperature', 'Chills', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH, 1073623,,,U,"A little sore arm; This is a spontaneous report from a contactable consumer (reporting for his co-worker). This consumer reported for similar events. This is the second of the two reports. A patient of unspecified age and gender received the first dose of bnt162b2 (also reported as PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date SINGLE DOSE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter was reporting that she had some side effects from the covid vaccine. She got the first dose on 22Dec2020 fine with just a little sore arm. Then got the second on 26Jan2021 (Tuesday) and on Friday she was in the ER for chronic pain in right side of her body. She says that she was experiencing a sharp pain or sensation of burning. The reporter later checked on the patient (a coworker) and experienced the same. The reporter just wanted to know if there are some reports of that. The outcome of the event was unknown. Case was considered as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021105945 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1073624,,,U,"chronic pain in right side of her body/sharp pain; experiencing a sharp pain or sensation of burning; This is a spontaneous report from a contactable consumer. This consumer reported for similar events. This is the first of the two reports. A patient of an unspecified age and gender received the second dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 29Jan2021, she was in the ER for chronic pain in right side of her body and also was experiencing a sharp pain or sensation of burning. The outcome of events was unknown. The information on the lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/29/2021,,UNK,,,,,,"['Burning sensation', 'Pain']",2,PFIZER\BIONTECH, 1073625,OK,58.0,F,"Swelling of lips; Sores in the mouth/the sores are underneath the lip by the cheek on top and bottom; the sores are underneath the lip by the cheek on top and bottom/sores being white on top and real red where the bump is, but on top of it, it's really white; body aches; chills; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL8982; expiration date: unknown) at vaccination age of 58-year-old via an unspecified route of administration in the left arm on 30Jan2021 11:30 at a single dose for COVID-19 Immunization. Medical history included Hashimoto's thyroiditis and acid reflux. Concomitant medication included levothyroxine for Hashimoto's thyroiditis and pantoprazole for acid reflux. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL1283; expiration date: Apr2021) at vaccination age of 58-year-old via an unspecified route of administration in the left arm on 09Jan2021 at a single dose for COVID-19 Immunization. The patient reported that she got her second shot on Saturday 30Jan2021 and yesterday (01Feb2021), her lips were swollen, and she has sores inside the mouth, the sores are underneath the lip by the cheek on top and bottom. She further reported that swelling was on both top and bottom lips, it occurred yesterday 01Feb2021, she noticed it as soon as woke. The sores in the mouth also started at the same time. She added that the lips swelling is ongoing but getting better. The Sores in the mouth, she thinks that they are getting better but it does bother her more when she is eating, but it is getting better, she only experiences pain on the sores when she is eating but other than that there is no pain. She has not used anything to treat the swelling and sores. The sores are sensitive to touch. She described the sores being white on top and real red where the bump is, but on top of it, it's really white. She has had no positive COVID Test prior to the first dose. She has had no issues with vaccines in the past. She also added that she did have chills and body aches on Saturday (30Jan2021) and Sunday (31Jan2021), she thought she was doing great, but then on Monday the sores showed up. She wanted to report this because no one said to her that would happen. She clarified that she experienced the chills on the same day of getting the second dose on 30Jan2021, then the body aches came Sunday 31Jan2021. The outcome of the events chill and ache were unknown while the outcome of the other events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,UNK,LEVOTHYROXINE; PANTOPRAZOLE,,Medical History/Concurrent Conditions: Acid reflux (oesophageal); Hashimoto's thyroiditis,,,"['Aphthous ulcer', 'Chills', 'Lip swelling', 'Pain', 'SARS-CoV-2 test', 'Stomatitis']",2,PFIZER\BIONTECH, 1073626,MI,72.0,M,"I got a swelling on my elbow; It is like a spongy node, it is like a ball of water; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 01Feb2021 at 16:00 at a single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. Consumer stated, ""I got my Covid 19 vaccination yesterday, the first one and I was reading all these side effects and the only thing that I had a question for is that I got the vaccination at approximately 4 O'clock in the afternoon and at 10 O'clock at night, on the arm that I got the shot, I got a swelling on my elbow. It is like a spongy node, it is like a ball of water and it is not at the injection site. It is on my elbow it just showed up. So, it is a side effect that I am reporting. I called the health department and they told me to call my physician. I called my physician, he told me to call my health department. You know, I got frustrated. I saw this number, I am calling you guys to report the side effect. It does not hurt and no pain. It is just a blob on my elbow."" The patient did not receive treatment for the event. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['Joint swelling'],1,PFIZER\BIONTECH, 1073627,OR,58.0,F,"zapped of energy; chilled; body aches; mild sore throat; slept about 15 hours; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN5318), via an unspecified route of administration single dose arm left on 29Jan2021 09:00 (at the age of 58) for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced zapped of energy on 31Jan2021 16:00, chilled on 31Jan2021 16:00, body aches on 31Jan2021 16:00, mild sore throat on 31Jan2021 16:00, slept about 15 hours on 31Jan2021 16:00. No treatment administered. The events outcome was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/31/2021,2.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Chills', 'Hypersomnia', 'Oropharyngeal pain', 'Pain']",1,PFIZER\BIONTECH, 1073628,AR,83.0,F,"fatigued; shooting pains under her armpit close to where she got the shot and the other side/shooting pains in her chest; shooting pains under her armpit close to where she got the shot and the other side/shooting pains in her chest; Chills; stated that she was cold; This is a spontaneous report from a contactable consumer (reporting for herself). A 83-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 28Jan2021 to 28Jan2021 at single dose for COVID-19 immunization. The patient's medical history included allergic mold, yeast and penicillin. Concomitant medications were not reported. On 30Jan2021, the patient experienced fatigued, shooting pains under her armpit close to where she got the shot and the other side, shooting pains in her chest, chills and stated that she was cold. The outcome of the events was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/30/2021,2.0,UNK,,,Medical History/Concurrent Conditions: Allergy to molds; Penicillin allergy; Yeast infection,,,"['Chest pain', 'Chills', 'Fatigue', 'Feeling cold', 'Pain']",1,PFIZER\BIONTECH, 1073629,TX,,F,"Fever; Severe headaches; cold sweat; joint and severe muscle pain; joint and severe muscle pain; This is a spontaneous report from a contactable consumer (patient). An elderly female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Jan2021 at 14:30 at single dose in right arm for COVID-19 immunisation. The patient was vaccinated at Public Health Clinic/Administration facility. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no known allergies. Medical history includes high blood pressure (HBP), diabetic. The patient received unspecified concomitant medications. On 26Jan2021 the patient experienced fever, severe headaches, cold sweat, joint and severe muscle pain. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment medication for headaches. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/26/2021,4.0,PUB,,,Medical History/Concurrent Conditions: Blood pressure high; Diabetic,,,"['Arthralgia', 'Body temperature', 'Cold sweat', 'Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH, 1073630,IL,41.0,F,"headache was heavy; her body and bones felt tired; sinuses felt heavy; shoulders are heavy; her thigh on the back is heavy; stated that she cannot move but can walk; neck on side when she has hiccups that she feels pain and in her back; neck on side when she has hiccups that she feels pain and in her back; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On the second day (Jan2021), her body and bones felt tired when she stretched and her sinuses felt heavy. On 01Feb2021, her headache was heavy. She took Benadryl. Her shoulders, neck on side and her thigh on the back were heavy on 2021. She cannot move but can walk on 2021. When she walks that it feels likes electricity. Also on 2021, her neck on side when she has hiccups that she feels pain and in her back. Patient was worried about it and wanted to know if it was normal to feel like this after the vaccine. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/01/2021,,UNK,,,,,,"['Back pain', 'Fatigue', 'Headache', 'Limb discomfort', 'Movement disorder', 'Musculoskeletal discomfort', 'Neck pain', 'Sinus disorder']",1,PFIZER\BIONTECH, 1073631,AL,,F,"vertigo; This is a spontaneous report from a contactable consumer (husband). This consumer reported similar events for two patients. This is 2nd of two reports. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date were not reported), via an unspecified route of administration on 30Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer (husband) and his wife received the first dose of the pfizer covid 19 vaccine on Saturday 30Jan2021. The patient (wife) experienced vertigo type symptoms on unspecified date. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106174 Same drug and event with different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,,,UNK,,,,,,['Vertigo'],1,PFIZER\BIONTECH, 1073632,NV,86.0,F,"cold sore; tuned a little red, it was sensitive in the center where the shot went in; tired; arm which was very sensitive to touch; Shaky; Sore arm, it was sensitive in the center where the shot went in; This is a spontaneous report from a contactable consumer (patient). An 86-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date: unknown), via an unspecified route of administration on the left arm, on 27Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medication. The patient experienced, after she pulled put from getting it, she got shaky on 27Jan2021. It went way after about 5 minutes. She gets that when gets a shot for dental work, so maybe it was the same reaction her body does, but it was gone before got home. On 27Jan2021, she had a sore arm for about 4.5 days, and it was difficult to sleep on that arm which was very sensitive to touch, and it turned a little red on 28Jan2021. She noted the soreness that night. She can lay on it now, it was sensitive in the center where the shot went in, but not bad. She was also tired that evening of 27Jan2021. She doesn't know if this has anything to do with it, but she got a cold sore, when she is stressed she gets a cold sore on her lip. This was noted yesterday (01Feb2020). She has medication for it from the doctor, and had to take for 3 days, and it usually clears it up. The cold sore was blistering, but she was susceptible to them with stress, so she was not surprised. Patient recovered from the event of tremor on 27Jan2021, turned a little red on 01Feb2021 and tired on 27Jan2021. Event sore arm was recovering while for the remaining events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Fatigue', 'Hyperaesthesia', 'Oral herpes', 'Tremor', 'Vaccination site erythema', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1073633,RI,,M,"soreness in arm approximately 4 hours after injecting; patient left work early due to feeling ill after the vaccine; This is a spontaneous report from a contactable consumer. An adult male patient received first dose of bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient described soreness in arm approximately 4 hours after injecting. The following day, the patient left work early due to feeling ill after the vaccine. This was his first vaccination in the covid-19 series. The outcome of the events was recovered. No treatment was given for the events. The patient did not have COVID-19 prior vaccination. It was unknown if the patient has been tested for COVID-19 post vaccination. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,PVT,,,,,,"['Malaise', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1073634,,31.0,F,"Fever; chills; This is a spontaneous report from a Non-contactable Pharmacist (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN5318), via an unspecified route of administration on 01Feb2021 at 10:30 AM (at the age of 31-years-old) at single dose in left arm for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) received on an unspecified date at single dose. The patient was vaccinated at workplace clinic. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included anxiety and known allergies to Sulfa. The patient received no concomitant medications. On 01Feb2021 at 20:00 the patient experienced fever and chills. No treatment was given for the events. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Anxiety; Sulfonamide allergy,,,"['Body temperature', 'Chills', 'Pyrexia']",2,PFIZER\BIONTECH, 1073635,CA,57.0,F,"Diarrhea; Chills; Cough; Sneezing; Nausea; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: unknown), via an unspecified route of administration on the left upper arm, on 30Jan2021, at single dose, for COVID-19 immunization, at a nursing home. Medical history included ongoing allergies which the patient was diagnosed before having the vaccine. There were no concomitant medications. The patient did not receive prior vaccinations within 4 weeks. On 30Jan2021, 2 hours after the vaccination, the patient experienced nausea. On 31Jn2021 at 03:00, the patient experienced chills, was coughing and sneezing. She stated that she was not coughing constantly, and it comes off and on. On 02Feb2021, the patient experienced diarrhea. She called her doctor and treatment included Tylenol and inhaler if needed. Her doctor would not give her prednisone so her lungs could get strong. The patient stated that she was scheduled to get her second dose on 20Feb2021. The patient recovered from nausea on 31Jan2021; was recovering from chills, cough and sneezing; and has not recovered from diarrhea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,SEN,,Allergy (she was diagnosed before having the vaccine.),,,,"['Chills', 'Cough', 'Diarrhoea', 'Nausea', 'Sneezing']",1,PFIZER\BIONTECH, 1073636,MO,75.0,M,"He is been sick all night/ Feeling unwell; Injection site pain; Headache; Chills; Fever; Fallen back to just sleep and a fast heartbeat; Fallen back to just sleep and a fast heartbeat; This is a spontaneous report from a contactable consumer (wife). A 75-year-old male patient (also the age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at the left arm 01Feb2021 11:15 at SINGLE DOSE for Covid-19 immunization. The patient medical history and patient's concomitant medications were not reported. It was reported that ""I am calling for about my husband (patient), well he took the Pfizer Vaccine (Covid-19 Vaccine) yesterday at 11:15 on the 01Feb2021 and he's been sick all night, he had the injection site pain, he has headache, chills, fever, he is just feeling unwell, I mean I think he is fallen back to just sleep and a fast heartbeat."" For the treatment it was stated ""Well, he in just on Tylenol, to keep his temperature down."" There was no visit made to Physician Office/ Emergency Room and the reporter stated, ""No, we haven't, I just wanted you to know there are some adverse effect that I am afraid people can't get through, I held it for 30 minutes, I don't know if you found out how many people get sick about it?"" The reporter asked, ""I kind of have a question, should the person if they have that much problem with that should he take the second shot."" The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,,,,,"['Chills', 'Headache', 'Heart rate', 'Heart rate increased', 'Malaise', 'Pyrexia', 'Somnolence', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1073637,AZ,63.0,F,"2 lumps on the collarbone, in the front. She guesses, they were lymph nodes; arm hurting; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL8982), via an unspecified route of administration on 29Jan2021 (1:00-1:30pm) at single dose on the upper left arm (arm left) for COVID-19 immunisation (reported as ""age 63, diabetes, is lucky to get being a part-time educator""). Vaccination facility type was school. Vaccine was not administered at military facility. Medical history included ongoing diabetes.The patient's concomitant medications were not reported. No other vaccines given the same day or 4 weeks prior. On 29Jan2021 (Friday), patient got her first COVID shot. On 01Feb2021, patient noticed she has 2 lumps on the collarbone, in the front. She guesses, they were lymph nodes. Patient called her doctor's office and was told to call Pfizer to ask for guidance. No other vaccines given the same day or 4 weeks prior. Patient had the usual arm hurting. In the past, she had the Shingles vaccine, felt kind of achy and a little tiredness, but never had this happen before (also reported as ""AE(s) following prior vaccinations: arm hurt, kind of achy and a little tiredness). Patient was going to wait to see if they go away, hoping they would go away and then if not she would make an appointment. Patient has diabetes and takes medication for that, but does not provide any further details. She wanted to know if this is something others have experienced or if this side effect has been reported or to possibly be expected. The events did not require emergency room and physician office visit. There were no family medical history relevant to events and relevant tests. Outcome of the events was not recovered (reported as ongoing).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/01/2021,3.0,SCH,,Diabetes,,,,"['Mass', 'Pain in extremity']",1,PFIZER\BIONTECH, 1073638,,,F,"exposed to someone who was diagnosed today with Covid; I had symptoms and chills; I now have a something in my chest; I do have little cough in my chest; This is a spontaneous report from a contactable consumer (reported for herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she has questions, they received their first, she and her husband were senior citizen they received their first Pfizer Covid 19 vaccine on 21Jan2021 and they have been exposed to someone who was diagnosed today with Covid. She had symptoms and chills days ago, chills and she now has something in her chest you know she was kind of, she was not, she doesn't have a fever, she has not run a fever or she doesn't feel horrible but she does have little cough in her chest. So, her question was since she and her husband had their test over a week and half ago, and this person who was now tested positive had their test too, had their first shot of Pfizer Covid vaccine two and half weeks ago, but now they were positive with Covid, what was their, how do they (she and her husband) proceed here, with their health concerns, he was definitely quarantined, okay, for 10 days but (incomplete sentence). The patient stated she already contacted her healthcare provider just waiting for a call from them but she thought maybe you would have some kind of input or information, you know if the shot was going to be affective if she tests positive or was this going to be affective for him, was it going to be affective for them or was it not going to be affective at all, and why did he get sick after getting the first shot. The patient underwent lab tests and procedures which included SARS-CoV-2 test: unknown results on Jan2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,,,UNK,,,,,,"['Chest discomfort', 'Chills', 'Cough', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1073639,NY,69.0,M,"Terrible burning sensation immediately after injection; Weird taste in mouth; Fatigue; Very thirsty; Mouth was dry; a little weak; Has a little anxiety every now and then; This is a spontaneous report from a contactable consumer (patient). A 69 -year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9263, expiration date:May2021), via an unspecified route of administration (on left arm) on 31Jan2021 09:15 (at the age of 69 -years-old), single dose for COVID-19 immunization. Medical history included ongoing chronic kidney disease and asthma. The patient's concomitant medications were not reported. Patient had Sore arm, left arm. Confirmed left arm received the COVID-19 Vaccine. Arm is still sore, but not as bad as the first and second day. Terrible burning sensation immediately after injection. Asked if that was normal. Felt injection going in. Patient had weird taste in mouth, very thirsty, mouth was dry. Could have been nerves because has a little anxiety every now and then. Today can taste blueberries and oatmeal. Almost like taste buds are back to normal. Patient had fatigue after he got home from the injection. Felt a little weak. Subsided for the most part and felt better yesterday afternoon. All the events started 31Jan2021. The outcome of the event vaccination site burning was not recovered, other events are unknown. No prior vaccination within 4 weeks, no adverse events following prior vaccinations.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,01/31/2021,0.0,UNK,,Asthma (Verbatim: Asthma); Chronic kidney disease (Verbatim: Chronic kidney disease),,,,"['Anxiety', 'Asthenia', 'Dry mouth', 'Fatigue', 'Taste disorder', 'Thirst', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1073640,MN,49.0,F,"Intense pain; intense joint pain; intense eye pain; intense headache; loss of balance; loss of appetite; stuffy nose; sneezing; drowsiness; confusion; agitation; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9269) via unspecified route on left arm single dose for COVID-19 immunization on 01Feb2021, 04:00 PM at 49-year-old. Medical history included: osteoarthritis, guttate psoriasis, degenerative disc disease, fibromyalgia, COVID-19, known allergies. Concomitant medication was not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK923) left arm for COVID-19 immunization on14Jan2021, 01:30 PM at 49-year-old; had body aches, fever, sore arm and skin ach. No other vaccine received in four weeks. On 02Feb2021, 02:00 AM, the patient had intense pain, intense joint pain, intense eye pain, intense headache, loss of balance, loss of appetite, stuffy nose, sneezing, drowsiness, confusion, agitation. Outcome of the events was not resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/02/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Allergy; COVID-19; Degenerative disc disease; Fibromyalgia; Guttate psoriasis; Osteoarthritis,,,"['Agitation', 'Arthralgia', 'Balance disorder', 'Confusional state', 'Decreased appetite', 'Eye pain', 'Headache', 'Nasal congestion', 'Pain', 'Sneezing', 'Somnolence']",2,PFIZER\BIONTECH, 1073641,,,F,"had a positive PCR; This is a spontaneous report from a contactable healthcare professional reporting for herself. This female patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced COVID-19 virus test false positive on 22Jan2021. The patient had a positive PCR on 22Jan2021 and she was advised to go ahead and get her dose of the vaccine. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,01/22/2021,,UNK,,,,,,['SARS-CoV-2 test false positive'],UNK,PFIZER\BIONTECH, 1073642,CT,27.0,F,"101 fever; lymph node swelling in my arm; full body aches and chills; full body aches and chills; headache; This 27- year-old female patient contactable consumer (reported for herself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 16Feb2021 (at the age of 27-years-old) as a single dose for COVID-19 immunization. The facility where COVID-19 vaccine was administered was at a Workplace clinic. She has had no other vaccines on the same day or in the past 4 weeks. The patient is not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical Vaccine included first dose of BNT162B2. Medical history and concomitant medications not reported. On 16Feb2021, the patient experienced a 101 fever, lymph node swelling in my arm, full body aches and chills, headache. The patient did not receive treatment for the events. The clinical outcome of the events 101 fever, lymph node swelling in my arm, full body aches and chills, headache was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/16/2021,0.0,WRK,,,,,,"['Body temperature', 'Chills', 'Headache', 'Lymphadenopathy', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1073643,GA,72.0,F,"second dose soreness in left arm, Nightime pain in right arm; cold not full chills but cold; shoulder neck down to wrist very sharp pains like muscle cramps; shoulder neck down to wrist very sharp pains like muscle cramps; shoulder neck down to wrist very sharp pains like muscle cramps; This is a spontaneous report from a contactable 72-year-old female consumer reported for herself that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3247) single dose on 16Feb2021 09:00 AM at left arm for COVID-19 immunization. Medical history was not provided. Historical vaccine included 1st dose of BNT162B2 (EL3247) on 25Jan2021 at 11:30 AM at left arm for COVID-19 immunization. Concomitant drugs included lisinopril, levothyroxine sodium (LEVOTHYROXIN), pravastatin, vitamin D and vitamin K. The patient reported second dose soreness in left arm, cold not full chills but cold, Nightime pain in right arm, shoulder neck down to wrist very sharp pains like muscle cramps started on 17Feb2021 at 01:00 AM. No treatment was received for the events. Event outcome was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,UNK,LISINOPRIL; LEVOTHYROXIN; PRAVASTATIN; VITAMIN D; VITAMIN K,,,,,"['Arthralgia', 'Feeling cold', 'Muscle spasms', 'Neck pain', 'Pain in extremity']",2,PFIZER\BIONTECH, 1073644,CT,38.0,M,"Pain in the injection site on left arm; dizziness; fatigue; back pain; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received second dose of bnt162b2 (lot number: 3247), via an unspecified route of administration, at arm left, on 16Feb2021 09:45 at single dose for COVID-19 immunisation. The patient medical history was not reported. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included fluticasone propionate (FLONASE) within 2 weeks of vaccination. Historical vaccine included first dose of bnt162b2 (lot number: 3247) at left arm on 26Jan2021 09:45 at 38-year-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Pain in the injection site on left arm; dizziness the next morning; fatigue; back pain on 17Feb2021. No treatment received for the adverse event. The case was reported as not serious. The outcome of the events were not recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,WRK,FLONASE,,,,,"['Back pain', 'Dizziness', 'Fatigue', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1073645,WA,25.0,M,"Within 1-2 minutes I experienced full body tingling; facial numbness; vision became distorted/blurry; vision became distorted/blurry; whole body was sweating; abdominal pain; lower extremity aching; nausea; experienced moderate to severe lower back spasms; sciatica; This is a spontaneous report from a contactable other health professional (patient). This 25-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# ELO739), via intramuscular on 04Feb2021 03:15 at single dose in the left arm for COVID-19 immunization. The patient's medical history included medullary kidney disease, and allergies to iodized contrast and bees (both resulting in anaphylaxis). The patient did not received any other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine administered was Public Health Clinic/Veterans Administration facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 1-2 minutes (03:15) patient experienced full body tingling and facial numbness. A minute later his vision became distorted/blurry and he began getting warn. A minute later his whole body was sweating, he was experiencing abdominal pain, lower extremity aching, and nausea. These symptoms other than the sweating persisted for another 5 days. After the 5th day, patient experienced moderate to severe lower back spasms and sciatica that resulted in an urgent care visit and a prescription for muscle relaxers and a mild pain reliever. The muscle spasms have been present for a week now and is slowly getting better. Patient was seen by an orthopedic urgent care where they recommended physical therapy and limited walking/sitting for extended periods of time. The adverse event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event included diphenhydramine hydrochloride (BENADRYL) (day of vaccination) and muscle relaxers. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of whole body was sweating and sciatica was not recovered, outcome of moderate to severe lower back spasms was recovering, outcome of other events was recovered on an unspecified date in Feb2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on event-vaccine chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/01/2021,,PUB,,,Medical History/Concurrent Conditions: Allergic reaction to bee sting (resulting in anaphylaxis); Iodine contrast media allergy (resulting in anaphylaxis); Kidney disorder,,,"['Abdominal pain', 'Hyperhidrosis', 'Hypoaesthesia', 'Metamorphopsia', 'Muscle spasms', 'Nausea', 'Pain in extremity', 'Paraesthesia', 'Sciatica', 'Vision blurred']",1,PFIZER\BIONTECH,OT 1073646,MS,40.0,F,"Chills; Body aches lasting a while; Joint pain everywhere; Head ache; This is a spontaneous report from a contactable consumer reported for herself. A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3247 and Expiration Date unknown) via an unspecified route of administration on 16Feb2021 10:00 AM (age at vaccination was 40 years old, vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3247 and Expiration Date unknown) via an unspecified route of administration on 26Jan2021 11:15 AM (vaccine location: Right arm) at single dose for COVID-19 immunisation. The patient's medical history included environmental allergies. The concomitant medications were reported none.Patient experienced chills, body aches lasting a while, joint pain everywhere and headache, all starting 14 hours and 30 mins after second dose on 17Feb2021.The outcome of events was recovering without treatment given. Information on the batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,WRK,,,Medical History/Concurrent Conditions: Environmental allergy (environmental allergies),,,"['Arthralgia', 'Chills', 'Headache', 'Pain']",2,PFIZER\BIONTECH, 1073647,MO,48.0,F,"chills; headache; low-grade fever (100 F); This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (EN5318) in left arm on 16Feb2021 14:00 at a single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Medical history was not reported. Allergies to medications, food, or other products was no. Pregnant at the time of vaccination was no. Prior to vaccination, was the patient diagnosed with COVID-19 was no. Concomitant medication included iron. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was no. List of any other medications the patient received within 2 weeks of vaccination was iron. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EN5318) in left arm on 26Jan2021 14:00 for COVID-19 immunization. Patient experienced chills, headache and low-grade fever (100 F) on 17Feb2021 02:00 for about 16 hours. No treatment was received. The outcome of the events was recovered. Events was considered non-serious. Since the vaccination, has the patient been tested for COVID-19 was no.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,WRK,IRON,,,,,"['Body temperature', 'Chills', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH, 1073648,WA,75.0,M,"Shingles; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the first dose of BNT162B2, via an unspecified route of administration on 02Feb2021 14:30 at single dose in Right arm for COVID-19 immunisation. Medical history included known allergies: Duck eggs, rheumatoid arthritis (RA), type 2 diabetes, all from an unknown date. Concomitant medications included RA injections. There was no other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient experienced shingles on 08Feb2021. Covid was not tested post vaccination. Therapeutic measures were taken as a result of shingles which included unspecified medication. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of event was recovering. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/08/2021,6.0,PVT,,,Medical History/Concurrent Conditions: Egg allergy; RA; Type 2 diabetes mellitus,,,['Herpes zoster'],1,PFIZER\BIONTECH, 1073649,MA,33.0,F,"flare up of my autoimmune thrombocytopenia; Platelets dropped to 109k; legs covered in petechiae and bruising; legs covered in petechiae and bruising; After 2nd dose, 1 day of headache; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EK4176 intramuscular in left deltoid on 07Jan2021 as single dose (at the age of 33 years) for COVID-19 immunisation. Patient had history of ongoing Autoimmune Thrombocytopenia from May2020, ongoing migraines, depression/anxiety and ADHD, and COVID-19 21Apr2020 to ""05May2021"". Concomitant medication included Sertraline Hydrochloride (ZOLOFT), Lisdexamfetamine mesilate (VYVANSE), Lorazepam (Ativan), Ondasetron (ZOFRAN) and Sumatriptan succinate (IMITREX). Historical information regarding dose 1 of BNT162B2 on 17Dec2020 included a moderate injection site reaction lasting 6 days worst on day three. Reaction was characterized by redness, swelling elevated rash surrounding injection site, aching pain radiating from neck to fingers and tenderness to palpitation. 1st dose Vaccine Lot Number: EJ1685, Vaccine Lot Expire Date: Mar2021, Time the Vaccination Was given: 08:00. After the 2nd dose the patient experienced a moderate headache on 08Jan2021 12:00 for 1 day which responded well to APAP- caffeine and resolved on 09Jan2021 12:00 Patient had a flare up of my autoimmune thrombocytopenia as evidenced by legs covered in petechiae and bruising on 09Jan2021. Emergency room and physician office were not visited however, patient does have standing CBC orders from hematologist, so she had platelet count checked. It had dropped to 109K/uL, which is low for me but not dangerous. Patient originally developed autoimmune thrombocytopenia (ITP) May2021 after COVID Apr2021. Both instances of these side effects were manageable, but patient wanted to report them as there was no data yet available on ITP with the vaccine when she met with hematologist to discuss it. Patient received Acetaminophen 650mg PO (per oral) as treatment. Lab data included Platelets 13Oct2020 124 kiU/L (normal 140-400) and on 12Jan2021 109 KiU/L. Event flare up of my autoimmune thrombocytopenia resolved on 31JAN2021 00:00, Platelets dropped to 109k resolved on 31JAN2021 00:00, legs covered in petechiae and bruising resolved on 31JAN2021 00:00 and headache resolved 09Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/08/2021,1.0,PVT,ZOLOFT; VYVANSE; ATIVAN; ZOFRAN [ONDANSETRON]; IMITREX,ADHD; Anxiety depression; Autoimmune thrombocytopenia; Migraine,Medical History/Concurrent Conditions: COVID-19,,,"['Condition aggravated', 'Contusion', 'Headache', 'Petechiae', 'Platelet count', 'Platelet count decreased']",2,PFIZER\BIONTECH,OT 1073650,MI,56.0,F,"swelling throat/ear canal on right side; swelling throat/ear canal on right side; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; This is a spontaneous report from contactable consumers (one was patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration at the right arm on 30Jan2021 10:30 at single dose for COVID-19 immunization. Medical history included food allergy (reported as allergy to walnuts). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. On 30Jan2021 10:45, both times the patient had right face numbness (felt like Novocaine) that started in her right cheek and spread to her lips and up into her eye and ultimately radiating throughout her head, and also swelling throat/ear canal on right side. It was unknown if treatment was received for the events. Clinical outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Food allergy (known allergies: Walnuts),,,"['External ear disorder', 'Hypoaesthesia', 'Hypoaesthesia eye', 'Hypoaesthesia oral', 'Pharyngeal swelling']",1,PFIZER\BIONTECH, 1073651,NY,91.0,M,"syncope; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in right arm on 18Feb2021 13:00 at single dose for covid-19 immunization. Medical history included dementia, diabetes, chronic kidney failure, known allergies: pencillin. Concomitant medication included insulin, metoprolol, memantine, omeprazole (PROTONIX), apixaban (ELIQUIS). On 20Feb2021 21:00, the patient experienced syncope followed by nausea and vomiting lasting about 4 hrs. No treatment received. Events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered on 21Feb2021 01:00. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/20/2021,2.0,UNK,INSULIN; METOPROLOL; MEMANTINE; PROTONIX [OMEPRAZOLE]; ELIQUIS,,Medical History/Concurrent Conditions: Dementia; Diabetes; Kidney failure chronic; Penicillin allergy,,,"['Nausea', 'Syncope', 'Vomiting']",1,PFIZER\BIONTECH, 1073652,NY,72.0,F,"Vomitting; severe abdominal pain secondary to pancreatitis; severe abdominal pain secondary to pancreatitis; This is a spontaneous report from a contactable Consumer (patient). A 72-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 19Feb2021 10:15 at single dose at right arm for covid-19 immunisation. No pregnant at time of vaccination. Medical history included Diabetes, three prior strokes, cardiac stent, Seafood and pollen allergy. Concomitant medication included paracetamol (TYLENOL) and unspecified medication. The patient experienced Vomitting, severe abdominal pain secondary to pancreatitis for nonalcoholic patient with no history of abdominal pain or gallstone on 19Feb2021 18:00, which lead to Emergency room/department or urgent care, Hospitalization. Hospitalization lasted 4 days. Therapeutic measures were taken as a result of events included unspecified therapy. The outcome of events was recovering. information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/19/2021,02/19/2021,0.0,PHM,TYLENOL,,Medical History/Concurrent Conditions: Diabetes; Pollen allergy; Seafood allergy; Stent placement; Stroke,,,"['Abdominal pain', 'Pancreatitis', 'Vomiting']",1,PFIZER\BIONTECH, 1073653,MI,56.0,F,"Bell's Palsy; eye twitching; dizziness; This is a spontaneous report from contactable consumers (one was patient). A 56-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6200, expiry date not reported), via an unspecified route of administration at the right arm on 20Feb2021 at single dose for COVID-19 immunization. Medical history included food allergy (reported as allergy to walnuts). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot number: EL9265, expiry date: not reported) in the right arm on 30Jan2021 10:30 at single dose for COVID-19 immunization but experienced face numbness and swelling throat/ear canal on right side. It was reported that the second dose was even worse than the first time and involved continued eye twitching and significant dizziness. The patient had not sought medical attention yet, but if it continued to get worse, she would call her doctor or (helpline number). The patient reported that it almost feels like Bell's Palsy on an unspecified date. It was unknown if treatment was received for Bell's palsy. Clinical outcome of Bell's palsy was not recovered, while for eye twitching and dizziness was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,,,WRK,,,Medical History/Concurrent Conditions: Allergy to nuts,,,"[""Bell's palsy"", 'Dizziness', 'Muscle twitching']",2,PFIZER\BIONTECH, 1073654,MO,67.0,F,"Bell's palsy; She cannot talk real well right now; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EN6200, unknown expiration), via an unspecified route of administration in right arm on 16Feb2021 at 10:55 at a single dose for COVID-19 immunisation in a hospital. Medical history included chickenpox and measles (when she was a kid), COVID-19 in 2020 (last year), ongoing anxiety, ongoing blood pressure (abnormal), and ongoing insomnia. Concomitant medications included pregabalin (LYRICA), celecoxib (CELEXA), and ongoing unspecified anxiety, blood pressure and insomnia medications. The patient received her first dose of BNT162B2 (lot number: EJ1686, unknown expiration) on 20Jan2021 at 11:33 in right arm for COVID-19 immunization. The patient's friend called on behalf of the patient because she cannot talk real well right now (Feb2021). The patient's friend confirmed that the patient went to emergency department and was told that she has Bell's palsy on 18Feb2021 at 14:00 and she has never had it before, and they did not know if it was a side effect from the COVID-19 vaccine or not. The patient received prednisone 20mg 3 times a day, Valpex, antibiotic, and eye drops for right eye as treatments. Blood test was taken on 18Feb2021 with unknown result. The patient had not yet recovered from the events. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/01/2021,,PVT,LYRICA; CELEXA [CELECOXIB],Anxiety; Blood pressure abnormal; Insomnia,Medical History/Concurrent Conditions: Chickenpox (When she was a kid); COVID-19 (Last year); Measles (When she was a kid),,,"[""Bell's palsy"", 'Blood test', 'Speech disorder']",2,PFIZER\BIONTECH, 1073655,,,F,"suffered an intracranial hemorrhage; subdural hematoma; fell; skull fracture; hemorrhage to right cerebrum; This is a spontaneous report from a contactable physician from a Pfizer-sponsored program. An 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 01Feb2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the 1st vaccine dose on 01Feb2021. The patient fell on 13Feb2021 with findings of a skull fracture and hemorrhage to right cerebrum and suffered an intracranial hemorrhage and subdural hematoma. The patient was hospitalized and was discharged on 16Feb2021. Her platelets were fine when she was discharged from the hospital. The patient has been home for 2 days and is scheduled to have her second dose of the vaccine on 22Feb2021. The physician wanted to know if the patient should postpone the 2nd dose and for how long or should she keep her appointment. Can the second vaccine dose be postponed past 21 days (as in 6 weeks or past 6 weeks instead of 3?). The outcome of the events was unknown. The patient fell, hit her head and had a brain bleed and fractured the back of her skull; the physician stated that it's not because of the Covid vaccine. Information on the lot/batch number has been requested.; Sender's Comments: In agreement with the reporting physician, the company considered that the fall and subsequent skull fracture, hemorrhage to right cerebrum, intracranial hemorrhage and subdural hematoma were due to an intercurrent accident, unrelated to suspect vaccine BNT162B2. There is no evidence or argument to suggest a causal relationship between BNT162B2 and the events.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/01/2021,02/13/2021,12.0,UNK,,,,,,"['Cerebral haemorrhage', 'Fall', 'Haemorrhage intracranial', 'Platelet count', 'Skull fracture', 'Subdural haematoma']",1,PFIZER\BIONTECH, 1073656,,,F,"Non-Hodgkin Lymphoma; She felt pain in her chest; Lymphedema; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 68-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on Jan2021 (at the end of January) at single dose for covid-19 immunization. Medical history included neoplasm malignant from an unknown date and unknown if ongoing She mentioned that she has cancer, non-Hodgkin Lymphoma and is in need of surgery , ongoing non-hodgkin's lymphoma She mentioned that she has cancer, non-Hodgkin Lymphoma and is in need of surgery. The patient's concomitant medications were not reported. The patient experienced non-hodgkin lymphoma, she felt pain in her chest, lymphedema on an unspecified date. The outcome of the events was unknown. She mentioned that she has cancer, non-Hodgkin Lymphoma and is in need of surgery. Consumer is asking for the vaccine efficacy after receiving one dose of the vaccine. Consumer mentioned that after the first dose, she felt pain in her chest and lymphedema, and is worried for her second shot. Consumer is asking about the allowed dosing interval between the first and second dose. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,,,UNK,,"Non-Hodgkin's lymphoma (She mentioned that she has cancer, non-Hodgkin Lymphoma and is in need of surgery)","Medical History/Concurrent Conditions: Cancer (She mentioned that she has cancer, non-Hodgkin Lymphoma and is in need of surgery)",,,"['Chest pain', 'Lymphoedema', ""Non-Hodgkin's lymphoma""]",1,PFIZER\BIONTECH, 1073657,CA,,F,"had a serious allergic reaction to her first COVID 19 shot; passed out while driving her car; On the way home she started to feel sick; She had a small accident, hitting a street sign; The next day she started having respiratory symptoms and spent the day in the ER because she was having difficulty breathing.; This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A female patient of an unspecified age received her fist dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a serious allergic reaction to her first COVID 19 shot. She waited after receiving the shot for 15 mins and felt fine. On the way home, she started to feel sick and passed out while driving her car. She had a small accident, hitting a street sign. The next day she started having respiratory symptoms and spent the day in the ER because she was having difficulty breathing. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Dyspnoea', 'Hypersensitivity', 'Loss of consciousness', 'Malaise', 'Road traffic accident']",1,PFIZER\BIONTECH, 1073658,CA,66.0,F,"break a blood vessel in her left eye; felt sick to her stomach; threw up; Half of the white in her left eye turned solid red; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date were not provided), via an unspecified route of administration on right arm, at 66-year-old (not pregnant at vaccination), on 15Feb2021 at 15:00 as a single dose for COVID-19 immunization. The vaccine was received in hospital. Medical history included ongoing chronic back pain, high blood pressure. No known allergies were reported. The patient did not experience COVID-19 prior vaccination. Concomitant medications included hydrocodone bitartrate, paracetamol (NORCO), fluoxetine hydrochloride (PROZAC), triamterene, baclofen. No other vaccine was received in four weeks. On 21Feb2012 at 12:00 (reported as 6 days later) the patient felt sick to her stomach and threw up which caused her to break a blood vessel in her left eye. Half of the white in her left eye turned solid red. Later she felt fine and was able to eat dinner. The patient did not have COVID-19 test post vaccination. The patient did not receive treatment for the events. The outcome of the events was recovering. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/21/2021,6.0,PVT,NORCO; PROZAC; TRIAMTERENE; BACLOFEN,Chronic back pain,Medical History/Concurrent Conditions: Blood pressure high,,,"['Eye haemorrhage', 'Nausea', 'Ocular hyperaemia', 'Vomiting']",1,PFIZER\BIONTECH, 1073659,VT,78.0,F,"Patient's heart went out of rhythm and began to beat very rapidly; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient (weight: 71.21 kg, height: 168 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6201) on the left arm, at single dose, on 17Feb2021, for COVID-19 immunisation. Relevant medical history included thyroid disorder and acid reflux (oesophageal), both from an unspecified date. Concomitant medication included levothyroxine, from an unspecified date, at an unknown dose, for thyroid disorder. On an unspecified date, in Feb2021, the patient's heart went out of rhythm and began to beat very rapidly. No treatment received. Blood test was performed on an unspecified date, in Feb2021 to check vitamin D level, B12 level and thyroid (unknown result). Post the vaccination, the patient has not been tested for COVID-19. Clinical outcome of the adverse event was unknown at time of this report.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/01/2021,,UNK,LEVOTHYROXINE,,Medical History/Concurrent Conditions: Acid reflux (oesophageal); Thyroid disorder (Taking levothyroxine),,,"['Arrhythmia', 'Blood test', 'Heart rate']",1,PFIZER\BIONTECH, 1073660,,,F,"she has lumps on her face; tingly tongue; kidney was hurting; nausea; her pallet was weird; She also had a metal taste in her mouth; skin broke out; blotches; her eyes got deteriorated; cyst in the liver; This is a spontaneous report from a contactable consumer (the patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date as a single dose for Covid-19 immunization. Medical history included high blood pressure and glaucoma from an unknown date and was allergic to iodine. Concomitant medications included timolol maleate (TIMOPTIC) Ocudose for glaucoma, carmellose sodium (REFRESH TEARS), macrogol 400, propylene glycol (SYSTANE) for dry eye relief and amlodipine, valsartan (EXFORGE) for high blood pressure, all from an unknown date. The patient experienced nausea, tingling in tongue, pallet was weird, metal taste in her mouth, her skin broke out (was not red but had blotches) and lumps on her face on an unknown date. She also experienced her eyes were deteriorated, kidney was hurting and the doctor found a cyst in the liver on an unknown date. The patient was rushed to the hospital for the nausea, tingling in tongue, pallet was weird and metal taste in her mouth and was kept for a couple of hours. The patient received Benadryl for the events tingling tongue, skin broke out, and blotches. The patient did go to the doctor for her skin, vision and hurting kidneys. The clinical outcome of the events dermoid cyst, paraesthesia oral, renal pain, nausea, oral disorder, dysgeusia, skin disorder, rash macular, visual impairment and hepatic cyst was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,TIMOPTIC; REFRESH TEARS; SYSTANE; EXFORGE,,Medical History/Concurrent Conditions: Blood pressure high; Glaucoma; Iodine allergy,,,"['Dermoid cyst', 'Dysgeusia', 'Hepatic cyst', 'Nausea', 'Oral disorder', 'Paraesthesia oral', 'Rash macular', 'Renal pain', 'Skin disorder', 'Visual impairment']",1,PFIZER\BIONTECH, 1073661,,,M,"has auto immune disorder; This is a spontaneous report from a Pfizer-sponsored program received from a non-contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient had first vaccine shot, has auto immune disorder ""prethzone"" (as reported) then scheduled for 2nd shot this Sunday, and has spoken to HCP. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Autoimmune disorder'],1,PFIZER\BIONTECH, 1073662,NJ,49.0,M,"IBD; Fever of 100.1; Bad nausea; Chills; Dizziness; fell down from the dizziness, lost his footing; Dizziness; fell down from the dizziness, lost his footing/suffered from dizziness before, but that was maybe about a year ago; Dizziness; fell down from the dizziness, lost his footing; dehydrated; This is a spontaneous report from a contactable consumer. A 49-years-old male patient (husband) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EK9231), via an unspecified route of administration on an unspecified date (49-years-old) at single dose (Left arm) for COVID-19 immunization. Medical history included dizziness. The patient's concomitant medications were not reported. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. It was reported that the app is down, the safety app because they were trying it. Reporter was calling to report side effects. Reporter and husband, for which they were calling about, they took the Pfizer COVID-19 Vaccine at 7:30 am on an unspecified date. When probed for side effects, reporter stated that the patient experienced Fever of 100.1, really bad nausea, and chills. He also experienced some dizziness, so much that he fell, he fell down from the dizziness, and he lost his footing. Reporter was informed about role of Pfizer Drug Safety. When asked about other medical conditions, reporter stated that he had dizziness, he had suffered from dizziness before, but that was maybe about a year ago, he suffered from occasional dizziness but he may have been dehydrated because he didn't have that much water today. On lab work, reporter stated that actually he did, it said something about the (statement incomplete), he did have blood work, but it said something about he has disposition, well, it's such a small sign of IBD (further details unknown). Reporter stated that they gave him two Tylenols 500 mg each as treatment. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Dizziness,,,"['Balance disorder', 'Blood test', 'Body temperature', 'Chills', 'Dehydration', 'Dizziness', 'Fall', 'Inflammatory bowel disease', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH, 1073663,NY,80.0,F,"hand felt like it was sleeping especially her finger tips it felt like neuropathy; Joint pain; Exhaustion; same arm that she broke, it seemed weaker now which it seemed like the side effects go to areas that were weakened before; with the arm the pain and movement in that arm has worsened since the injection; with the arm the pain and movement in that arm has worsened since the injection; with the arm the pain and movement in that arm has worsened since the injection; with the arm the pain and movement in that arm has worsened since the injection; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL9266 and expiry date 31May2021, via unspecified route of administration on 15Feb2021 at single dose for Covid-19 immunization. Medical history included, broke her elbow from 04Dec2020 and surgery from 12Dec2019 and second surgery was from 15Jul2020; the patient thought that the second surgery on her arm was in 2020 and she actually broke her arm in 2019. She thinks it was actually Dec2019 when she broke her arm and the second surgery was on 15Jul2020; ongoing with the arm the pain and movement in that arm (movement disorder) and arm; weakened (same arm that she broke). There were no concomitant medications. The patient was taking the same medications she always takes, and she waited until after the dose to take them. Historical vaccine included first dose of BNT162B2 lot number EL02162, expiry date 31May2021 for Covid-19 immunization. The patient was calling about the vaccine, the second Pfizer COVID 19 vaccine. She experienced some side effects, there was joint pain on 15Feb202 later that nigh and the most obvious thing was exhaustion that began later the same day as well; but one thing was unusual, the strange side effect that has happened on 16Feb2021 was that her hand felt like it was sleeping especially her finger tips it felt like neuropathy but it was much better now, it was the same arm that she broke, it seemed weaker now which it seemed like the side effects go to areas that were weakened before. The patient stated that the main thing was the neuropathy thing, it felt like she was sitting on her hand and that persisted, but it was 90 percent better and she thinks it will go away. The neuropathy feeling was ongoing but much less, it was improved it happens only if she squeezes her hand so it was much less and she hoped it just dissipates. The patient's main concern was the neuropathy and it has improved a great deal. The patient mentioned with the arm the pain and movement in that arm has worsened since the injection (Feb2021). The worsened pain and movement has persisted about the same since she noticed it. The patient informed that was the joint she guessed, because she broke the elbow. The outcome of the events hand felt like it was sleeping especially her finger tips it felt like neuropathy, joint pain, exhaustion was recovering, same arm that she broke, it seemed weaker now which it seemed like the side effects go to areas that were weakened before was unknown, while not recovered for the rest of the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/01/2021,,UNK,,Movement disorder; Pain in arm; Weakness of arms (same arm that she broke),Medical History/Concurrent Conditions: Arm fracture; Elbow fracture (had surgery on the 12Dec2020); Surgery (second surgery; broke her elbow/broke her arm); Surgery (broke her elbow),,,"['Arthralgia', 'Condition aggravated', 'Fatigue', 'Movement disorder', 'Muscular weakness', 'Neuropathy peripheral', 'Pain in extremity']",2,PFIZER\BIONTECH, 1073664,,,M,Respiratory infection; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date at a single dose as Covid vaccine. Medical history included COPD (chronic obstructive pulmonary disease) and disabled. Concomitant medications included budesonide/formoterol fumarate (SYMBICORT) and tiotropium bromide (SPIRIVA). The patient previously took paracetamol (TYLENOL) prior to the 1st dose. The patient got both doses of the Covid vaccine. He took Tylenol prior to the 1st dose and wanted to know if that would do anything to the vaccine. He was also on an antibiotic from Pfizer for a respiratory infection on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,SYMBICORT; SPIRIVA,,Medical History/Concurrent Conditions: COPD; Disability (disabled),,,['Respiratory tract infection'],1,PFIZER\BIONTECH, 1073665,IN,59.0,F,"mitral valve flare up; Heart palpatation; face numbness/ Numbness in right cheek; tingling finger/ tingling in right fingers; This is a spontaneous report from a contactable healthcare professional. A 59 -year-old female patient (not pregnant at time of vaccination) received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6201), via an unspecified route of administration (on left arm) on 18Feb2021 12:00 (at the age of 59-years-old), single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date. Concomitant medication included levothyroxine, propranolol, omeprazole (PROTONIX), linaclotide (LINZESS). The patient previously took codeine, prednisone, dtap, had known allergies: Codeine prednisone and dtap. The patient experienced heart palpitation, face numbness, tingling finger, all on 18Feb2021 1500. Numbness in right cheek and tingling in right fingers and motto valve flare up, all on 19Feb2021, the events resulted in Emergency room/department or urgent care.No treatment given for adverse events. The outcome of the events were recovering. No other vaccine in four weeks. No covid prior vaccination. Not covid tested post vaccination.; Sender's Comments: Based on available information, the Company considered all reported serious and non-serious events as possibly associated to BNT162B2 injection, due to a plausible chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,PVT,LEVOTHYROXINE; PROPRANOLOL; PROTONIX [OMEPRAZOLE]; LINZESS,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Hypoaesthesia', 'Mitral valve prolapse', 'Palpitations', 'Paraesthesia']",1,PFIZER\BIONTECH, 1073666,MD,31.0,M,"Swelling on the left side of my face over my Jaw/My face was severely swollen and the swelling was going down into my neck on both sides/The swelling in my face and neck had returned; Swelling on the left side of my face over my Jaw/My face was severely swollen and the swelling was going down into my neck on both sides/The swelling in my face and neck had returned; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received his first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201), via an unspecified route of administration at right arm at the age of 31-year-old on 13Feb2021 07:00 at single dose for Covid-19 immunisation. Medical history included allergies to Sulfa. There were no concomitant medications in two weeks or other vaccine in four weeks. On Monday 22Feb2021 06:00 AM, the patient woke up in the morning with swelling on the left side of his face over his Jaw. Throughout the day the swelling increased and began to swell on the right side as well. That evening he went to an urgent care and was prescribed an antibiotic. When he woke up in the morning of Tuesday the 23Feb2021 his face was severely swollen and the swelling was going down into his neck on both sides. He went to the emergency room (ER) and was admitted overnight. He was given intravenously (IV) antibiotics, steroids and fluids. All blood tests came back normal and negative(Feb2021). When the swelling went down considerably, he was discharged on Wednesday 24Feb2021 and sent home with a steroid and antibiotic to take orally. Upon waking up this morning, on 25Feb2021 the swelling in his face and neck had returned. Adverse events were resulted in emergency room/department or urgent care and hospitalization. There was no COVID prior vaccination. The COVID tested post vaccination. The patient underwent lab tests included nasal swab was negative on 23Feb2021. The outcome of events was not recovered.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/13/2021,02/22/2021,9.0,UNK,,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,"['Blood test', 'SARS-CoV-2 test', 'Swelling', 'Swelling face']",1,PFIZER\BIONTECH, 1073667,FL,70.0,F,"shortness of breath; A fib; Had water in my lungs; This is a spontaneous report from a contactable consumer (patient self). A 70-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, LOT number and expiration date: unknown) via an unspecified route of administration (location: left arm) on 29Jan2021 at age of 70-year-old at single dose for COVID-19 immunisation. Medical history included high blood pressure, diabetes. She had known allergies: Penicillin. The patient had a history of atrial Fib (Atrial fibrillation) but had been in sinus rhythm for a long time. No COVID prior vaccination. Concomitant medication included dabigatran etexilate mesilate (PRADAXA). On 30Jan2021 09:00 AM, after first dose of BNT162B2, she went to the emergency room (ER) with shortness of breath and in A fib (Atrial fibrillation), she also had water in her lungs. The events were resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient stayed for 5 days in hospital. She received unspecified medications as treatment. COVID tested post vaccination (Nasal Swab) on 22Feb2021 resulted negative. The outcome of events was recovering. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/29/2021,01/30/2021,1.0,UNK,PRADAXA,,Medical History/Concurrent Conditions: Atrial fibrillation (had been in sinus rhythm for a long time); Diabetes; Hypertension; Penicillin allergy,,,"['Atrial fibrillation', 'Dyspnoea', 'Pulmonary oedema', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1073668,,,F,"Pneumonia; arm soreness; This is a spontaneous report from a contactable consumer (patient's boyfriend). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient experienced arm soreness after first dose. And she was prescribed azithromycin (ZITHROMAX) and amoxicillin/ clavulanic acid (AUGMENTIN) to take because she was just diagnosed with pneumonia. And it's due for her second dose ""tomorrow"" 26Feb2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Pain in extremity', 'Pneumonia']",1,PFIZER\BIONTECH, 1073669,OH,,F,"Burst blood vessel in her eye; Really bad headache/Her head was throbbing; Chills; Sinus headache; Her ear hurt; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9266, expiration date: 31May2021, via an unspecified route of administration at left arm on 17Feb2021 at a single dose for Covid-19 immunisation. Medical history included migraine diagnosed 35-40 years ago, aneurysm from 01Aug2018 and lung cancer. There were no concomitant medications. The patient reported that she had a really bad headache the next day on 18Feb2021, after getting her first dose of the vaccine on Wednesday, 17Feb2021. She sated that on the 18th she had chills and the really bad headache, and she has a history of migraines and also has an aneurysm in her brain which she doesn't know how long that has been there. She says she also looked in the mirror this morning 19Feb2021, while putting her make up on and saw that a blood vessel had burst in her eye, which could have been from the pressure she had from the headache. She says her second dose is scheduled on 10Mar2021. She says that she had a little headache the afternoon she got the vaccine that went away, then the next morning at 04:00 am her head was throbbing, and she suffers from migraines but this felt like a sinus headache. Her ear hurt and she thought it was more sinus then, and nothing she took for it would alleviate the pain. She says when she got up then she got chills. She says that nothing she did like she normally does helped, like she tried heat and cold it was not going to give. She says that she used ice packs then put heat on her shoulder, and also did a Neti pot, maybe that caused her eye have blood vessel burst in it, she doesn't know. She says that the blood vessel burst in her right eye, which seems to have gotten better since this morning, it is not quite as red. She says it could be that she rubbed it. She says her headache is gone now and her chills are gone. The patient recovered from the events really bad headache/Her head was throbbing and chills on 19Feb2021, for the event burst blood vessel in her eye was recovering. The outcome of the event Sinus headache was not recovered while the outcome of the event ear hurt was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/18/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Aneurysm (Verbatim: Aneurysm); Lung cancer (Verbatim: Lung cancer); Migraine (Verbatim: Migraine/ Caller says this was diagnosed 35-40 years ago.),,,"['Chills', 'Ear pain', 'Eye haemorrhage', 'Headache', 'Sinus headache']",1,PFIZER\BIONTECH, 1073670,NY,46.0,M,"Atrial fibrillation; This is a spontaneous report from a contactable consumer (patient himself). A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided), via an unspecified route of administration at Left arm on 23Feb2021 12:00 pm (at 46-year-old) at single dose for COVID-19 immunisation in hospital. Medical history included Seminoma from 2011, Suframides allergy. The patient's concomitant medications were not reported. The patient experienced Atrial fibrillation on 25Feb2021 02:30 am. No other vaccine in four weeks. No Other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. The events were not resulted in emergency room visit or physician office visit. No treatment received. The outcome of the event was Recovered on 25Feb2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/25/2021,2.0,PVT,,,Medical History/Concurrent Conditions: Seminoma; Sulfonamide allergy,,,['Atrial fibrillation'],1,PFIZER\BIONTECH, 1073671,MA,24.0,F,"sudden feelings of nausea; dizziness; rapid heart rate; sweating; tingly sensation in extremities; sudden fatigue; confusion; Chest tightness and pressure; This is a spontaneous report from a contactable healthcare professional (patient herself). A 24-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN9581) on 13Feb2021 12:30 PM, via unknown route of administration, at the age of 24-year-old at single dose in Left arm for COVID-19 immunization. The patient medical history includes known allergies: Penicillin, Sulfur meds. The patient concomitant drug includes desvenlafaxine succinate (PRISTIQ). 10 mins after shot (as reported), the patient experienced sudden feelings of nausea, dizziness, rapid heart rate, sweating, tingly sensation in extremities, sudden fatigue, confusion. Chest tightness and pressure lasting 4 days. All the events reported started at 13Feb2021 12:45 PM, resulted in: [Emergency room/department or urgent care, Prolongation of existing hospitalization (vaccine received during existing hospitalization)]. Treatment was reported as no. No COVID prior vaccination. No COVID tested post vaccination. The event outcome of 'Chest tightness and pressure' was recovered on 17Feb2021 and the rest of event was recovered in Feb2021.; Sender's Comments: Based on the temporal relationship, the reasonable possibility of an association between reported events and suspect product BNT162B2 cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/13/2021,0.0,UNK,PRISTIQ,,"Medical History/Concurrent Conditions: Penicillin allergy (known allergies: Penicillin, Sulfur meds); Sulfonamide allergy (known allergies: Penicillin, Sulfur meds)",,,"['Chest discomfort', 'Confusional state', 'Dizziness', 'Fatigue', 'Heart rate', 'Heart rate increased', 'Hyperhidrosis', 'Nausea', 'Paraesthesia']",1,PFIZER\BIONTECH, 1073672,OH,41.0,F,"coronary artery spasms; This is a spontaneous report received from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Em9810), on 04Feb2021 04:00 PM (at the age of 41-year-old) on left arm at single dose for COVID-19 immunization. It was reported that patient was not pregnant the time of event and at the time of vaccination. The patient's medical history included hypertension, covid prior vaccination and no known allergies. The patient's concomitant medications included buspirone, bupropion and lisinopril. No other vaccines were administered in four weeks prior to vaccination. It was reported that unknown if related but odd that this happened one week after her initial vaccine (11Feb2021 10:00 AM). She was hit with what felt like a heart attack. Emergency room (ER) ruled out heart attack but it was possibly coronary artery spasms. She was getting heart monitor because she continued to have episodes that were decreasing in intensity each time (she got around 2 per week). The event was reported as serious with criteria hospitalization. The patient was hospitalized for one day (Feb2021). Therapeutic measure was taken as a result of the event and included that patient was put on new medicine verapamil. The outcome of the event was resolving.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/04/2021,02/11/2021,7.0,PUB,BUSPIRONE; BUPROPION; LISINOPRIL,,Medical History/Concurrent Conditions: COVID-19 (prior vaccination); Hypertension,,,"['Arteriospasm coronary', 'Cardiac monitoring']",1,PFIZER\BIONTECH, 1073673,NJ,68.0,F,"she is having confusion and dementia,; went into this kind of like dementia-like state where she talked incessantly/ she is having confusion and dementia,; She had days of vomiting and nausea; She had days of vomiting and nausea; She complained of brain fog and couldn't focus on the tv or her programs; kidney functions were not good enough; she has mood swings; she could not remember or know everything from the present; she had a UTI; This is a spontaneous report from a contactable consumer (patient's sister). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular injection on 20Jan2021 (at the age of 68-year-old) at single dose for COVID-19 immunisation. Medical history included ongoing breast cancer stage IV, patient was in treatment for breast cancer stage IV, she had cancer 13 years prior the report in 2008, and then was found again and diagnosed 3 years prior the report, in Jun2018; chronic obstructive pulmonary disease (COPD), a long time, a lot of her adult life. The patient was on oxygen; she had a lot of fluid built up from the cancer; patient tested positive for COVID in 2020 (Feb2020 or Mar2020, as reported). She and her roommate tested positive and had a cough. They had no fever or other symptoms. Both in the nursing home got over the cough and 21 days later tested negative. Patient tested negative for COVID ever since. The nursing home tested the residents and staff every week. They had tested the patient so much to the point her nose was bloody which the reporter got upset about; hallucinations and paranoid thoughts. Concomitant medications included ongoing perphenazine (TRILAFON) taken for hallucinations and paranoid thoughts; treatment for breast cancer stage IV and oxygen. The patient lived in nursing facility and had received both Pfizer vaccine doses. The patient received the first vaccine for COVID-19 immunisation in Dec2020. She was fine. She got the second one on 20Jan2021. Since patient received the 2nd vaccine dose, in Jan2021, she was having confusion and dementia, which was not an issue before the vaccine doses. The patient was having trouble putting words together. Patient initially had vomiting, nausea and brain fog where she could not concentrate on her TV, in Jan2021. She was hospitalized from 17Feb2021 to 20Feb2021 to have all kinds of tests run and see if her cancer had spread to her brain. Patient had 3 years with stage 4 breast cancer and had fought so hard and was aware of her confusion and it was very upsetting to her. She had days of vomiting and nausea. She complained of brain fog and could not focus on the tv or her programs. Within days, she went into this kind of like dementia-like state where she talked incessantly and could not get a thought completed. Patient would go from one thought to the next. It was very bizarre. She had never had this kind of issues. This went on for so long, they finally put her in the hospital. Patient had stage 4 breast cancer, and the doctors thought maybe her cancer had gone to her brain. The doctor did not think it was related to the COVID-19 vaccine. She was checked for a urinary tract infection (UTI), for brain cancer, for a stoke, for everything. She saw so many doctors. She still had not come out of this a month later. She was currently on psych meds because she had mood swings, since Jan2021. It had been one thing after another. The patient could not tell the time. On some level, patient knew something was wrong. She was in a very confused state. She did not know how to tell anyone what she wanted to tell. It was very distressing to say the least. She had made a little bit of progress. She could tell time with some struggling but she got upset and cried. Patient could only tell that the time was 3, but not 3:15. But, then she cried and got upset. She had been able to tell time a couple of times, but if you asked her what day was it, she had no clue. She had no clue what day it was and would ask ""what day is it?"" Her moods all over the place. The patient was still very confused. The reporter explained the patient could be 5'3'', she was unsure. The reporter really did not know the patient weight, she was guessing around 270lbs. She had a lot of fluid built up from the cancer, and reporter had not seen her since COVID started. Patient told that her weight was up around 300lbs. The reporter declined to include a healthcare professional for the report, stating she had not spoken to her sister's primary care doctor. She was waiting for her to call back. The patient was sent to the ER and admitted into the hospital on 17Feb2021. She came back from the hospital on 20Feb2021 at 6:30pm. She had a CAT scan, MRI, bloodwork done, in Feb2021. She saw a psychiatrist, neurologist, her oncologist. There was so many doctors seeing her and talking to the reporter. The last doctor the patient saw in the hospital said that she thought the patient was dehydrated from her vomiting episodes, but did not know for sure. In Feb2021, the nursing home did blood tests and a urinalysis to see if she had a UTI. The blood work would have shown if patient was dehydrated and she was not. The head nurse thought it was the vaccine, but she was not sure. Everybody was not sure. No one could tell her anything concrete about patient. She was not normally like this. Patient had recovered completely from the nausea and vomiting. They tried for a while to give her an anti-nausea medicine, but she could not keep anything down. It was given to her orally, she did not know why an injection was not given. This lasted for a few days, clarified as maybe 3 days. The reporter had no name, NDC, lot number or expiry date for the anti-nausea medicine the patient took. She knew it was given to her once and when they tried to give it to her again, patient refused. Reporter had no product information to provide for the first and second doses of the COVID-19 vaccine, did not have the patient vaccine record card. This would be with the nursing facility. She mentioned patient went into the nursing home on Jan2018 and then was diagnosed with breast cancer Jun2018. She did not know if there were any interactions there with the patient having the breast cancer and receiving the COVID-19 vaccine. The reporter had no product information for the first dose. When probed for the date in which the first dose was given, she explained she was sent constant emails which could have provided a date, but she did not know this information offhand. It was approximately a month before the second dose, or it could have been on 27Dec2020, which was a little closer than a month apart. No additional vaccines were administered on the same date of the Pfizer vaccine. The events required a visit to emergency room. Patient had constant testing while in the hospital. In the hospital, in Feb2021, they did MRI and CAT scan to see if the breast cancer had gone to the brain and both were negative. They tested for UTI. They did the first UTI test at nursing home in 2021 and they said she had a UTI and patient was put on an antibiotic. They tested her again for a UTI when she was admitted into the hospital in Feb2021 and they said she did not have a UTI. She did have a buildup of urine in her bladder because her kidney functions were not good enough for the MRI at first, in Feb2021. Her bladder was relieved of the urine build up and her kidney functions improved and she was able to get the MRI. The MRI did not show any cancer in the brain. None of it relieved her symptoms. This was just bizarre. It happened within a week of receiving the vaccine. She could not talk with patient and patient had never been like that. The patient had always been lucid and open and you could talk about anything: the past, the present, she had no problems. She could remember everything crystal clear from the past but she could not remember or know everything from the present. The reporter would ask her what day was it and the patient did not know. The patient would absorb the information she was told but there was like this strange disconnect, almost like a dementia of some form. About concomitant medications, the reporter explained the patient had not started anything new. She had been on the same stuff for many years. She had psych meds that she had been on, but she had been on those for many years. She clarified further that patient had been stable on her psych meds for many years, and the nursing facility had the patient stable for 3 years at the nursing home. At the time of the report, her mood swings were all over the place, she had never had that before. She had hallucinations and paranoid thoughts in the past, but she had never had mood swings like this and never had dementia. She had been on the same medications for a long time, but they were currently trying to play with them and trying to adjust her psych meds. It was apparent it was not working and this was something more organic, something going on in her body. The psych med was perphenazine all of her life. The psych nurse was a new nurse and was not familiar with the patient. The psych nurse informed the reporter she raised the perphenazine to the highest dose she could possible go on and told she could have to try the patient on a mood stabilizer and could have to put her in a psych unit. The reporter would not have any NDC, lot numbers or expiration dates, or anything like that. The reporter had been told an UTI could have caused the patient symptoms. It could have been brain cancer, or this or that. She did not know what was going on. Reporter asked if there had been any reports or had other people called in with these types of reactions or adverse events. The patient had recovered from vomiting and nausea on an unknown date in 2021, had recovered from kidney functions were not good enough and UTI in Feb2021, the outcome of the other events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/20/2021,01/01/2021,,SEN,TRILAFON [PERPHENAZINE],"Breast cancer stage IV (then was found again and diagnosed 3 year ago in June, clarified as Jun2018)","Medical History/Concurrent Conditions: Bleeding nose; COPD (The patient was on oxygen.); COVID-19 (had a cough, no fever or other symptoms); Fluid retention (from the cancer); Hallucinations; Paranoid state",,,"['Blood test', 'Body height', 'Computerised tomogram', 'Confusional state', 'Dementia', 'Feeling abnormal', 'Magnetic resonance imaging', 'Memory impairment', 'Mood swings', 'Nausea', 'Renal impairment', 'SARS-CoV-2 test', 'Urinary tract infection', 'Urine analysis', 'Vomiting', 'Weight']",2,PFIZER\BIONTECH,OT 1073674,MN,,M,"pneumonia; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (reporting for husband) reported that a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter mentioned that they will not get the vaccine scheduled on Wednesday (24Feb2021) as her husband got hospitalized (dates unspecified) because of pneumonia on an unknown date. Reporter was asking if they can extend the date of the second dose. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,['Pneumonia'],1,PFIZER\BIONTECH, 1073675,,,M,"It looks like bullous pemphigoid; he developed an erythematous rash on his extremities which has begun to blister.; he developed an erythematous rash on his extremities which has begun to blister.; This is a spontaneous report from a contactable physician via a sales representative. A 69-year-old male patient received second dose of bnt162b2 (bnt162b2), via an unspecified route of administration from on an unspecified date at SINGLE DOSE for covid-19 immunisation. Medical history included diabetes and parkinson's disease. The patient's concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunisation on an unknown date. After received r the second dose of the bnt162b2, two days post doe the patient developed an erythematous rash on his extremities which had begun to blister. It looked like bullous pemphigoid. The event outcome was unknown.; Sender's Comments: Based on the available information and on a reportedly close temporal association, causality cannot be excluded between the events and the administration of the suspect product BNT162B2 (COVID-19 MRNA VACCINE BIONTECH). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Diabetes; Parkinson's disease,,,"['Blister', 'Pemphigoid', 'Rash erythematous']",2,PFIZER\BIONTECH, 1073676,,,F,"Severe pain episodes; Arm soreness; fatigue; intermittent body pain; intermittent headaches with highest level of pain at 7; This is a spontaneous report from a contactable consumer. A 16-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 13Feb2021 at SINGLE DOSE for covid-19 immunisation. Medical history included neurological issues for over 2yrs. The patient's concomitant medications were not reported. It was reported that, after first dose of vaccine, since Feb2021, the patient experienced arm soreness, fatigue, intermittent body pain, intermittent headaches with highest level of pain at 7, using scale of 0-10, with 0 being no pain. Intermittent pains still continue. The patient had a history of neurological issues for over 2yrs. Severe pain episodes requiring hospitalization in Feb2021. Triggers for episodes have not been determined. The patient was on 25mg amitriptyline QHS (before bed). It's possible that the first dose of the BNT162B2 has triggered the beginning of an episode. Lab data on Feb2021 included pain highest level of pain at 7, using scale of 0-10, with 0 being no pain. The event outcome was reported as unknown. Information about Batch/Lot number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/13/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Neurological symptom (history of neurological issues for over 2yrs),,,"['Fatigue', 'Headache', 'Pain', 'Pain assessment', 'Pain in extremity']",1,PFIZER\BIONTECH, 1073678,NJ,46.0,M,"relapse of chronic inflammatory demyelinating polyneuropathy; relapse of chronic inflammatory demyelinating polyneuropathy; This is a spontaneous report from a contactable consumer (patient self). A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, LOT number and expiration date: unknown) via an unspecified route of administration on 21Feb2021 13:30 at single dose for COVID-19 immunisation. Medical history included ongoing chronic inflammatory demyelinating polyneuropathy (CIDP). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. No Covid prior vaccination. There were no concomitant medications. The patient reported he was fine until after the second dose and he was having a relapse of chronic inflammatory demyelinating polyneuropathy on 23Feb2021 12: 00 AM. The event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient was trying to get intravenous immunoglobulin (IVIG) as treatment. Covid was not tested post vaccination. The outcome of event was unknown. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,U,02/21/2021,02/23/2021,2.0,UNK,,Chronic inflammatory demyelinating polyneuropathy,,,,"['Chronic inflammatory demyelinating polyradiculoneuropathy', 'Condition aggravated']",2,PFIZER\BIONTECH, 1073679,TX,28.0,M,"Pulmonary embolisms; lung infarcts in left and right lungs; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL5269), via an unspecified route of administration at site of left arm at 15:00 on 08Feb2021 at single dose for COVID-19 immunisation. Medical history included psoriasis and known allergies: clarithromycin. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date. The patient experienced pulmonary embolisms and lung infarcts in left and right lungs on 11Feb2021. The patient was hospitalized for these events for 2 days. COVID was tested post vaccination (Nasal Swab covid test with negative result on 12Feb2021). No other vaccine received in four weeks. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient received treatment (blood thinners and CT Imaging) for adverse event. No COVID prior vaccination. The outcome of events was recovered in Feb2021.",Not Reported,,Yes,Yes,2.0,Not Reported,Y,02/08/2021,02/11/2021,3.0,UNK,,,Medical History/Concurrent Conditions: Drug allergy; Psoriasis,,,"['Computerised tomogram', 'Pulmonary embolism', 'Pulmonary infarction', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1073680,AZ,70.0,M,"The heels on both feet became painful; Pain was so severe I could not walk for several days; This is a spontaneous report from a contactable consumer. A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL3247, via an unspecified route of administration on 03Feb2021 07:30 at SINGLE DOSE for covid-19 immunisation; vaccine location: left arm; dose number: 1; facility type vaccine: hospital and pravastatin (PRAVASTATIN), via an unspecified route of administration from an unspecified date to an unspecified date at UNK for an unspecified indication. The patient medical history and concomitant medications were not reported. In 1971 the patient took rabies vaccine inact (duck embryo) and experienced anaphylactic reaction. Approximately one week after the vaccination, on 07Feb2021 07:30, the patient experienced ""heels on both feet became painful. The pain was so severe I could not walk for several days"". The pain was present all day, even all night long. The patient was treated with ibuprofen Outcome: recovering. . Information on Batch/lot has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/07/2021,4.0,PVT,Pravastatin,,,,,"['Gait inability', 'Pain in extremity']",1,PFIZER\BIONTECH, 1073682,NJ,80.0,M,"pulmonary edema; Low heart rate; chest pain; This is a spontaneous report from a contactable pharmacist. An 80-years-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 28Jan2021 at single dose for COVID-19 Immunisation. Medical history included dementia, high blood pressure, COVID prior vaccination. He had no known allergies. Concomitant medication included diltiazem hydrochloride (CARDIZEM), anastrozole (ARIMIDEX), simvastatin and lorazepam. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 (at the age of 80-years-old) at single dose for COVID-19 Immunization. There was no other vaccine received in four weeks. The patient experienced pulmonary edema, low heart rate and chest pain on 26Feb2021. The events resulted in hospitalization and patient died. The patient was hospitalized from 26Feb2021 for 1 day. Treatment received for the events included Epinephrine, morphine, nitroglycerine. The patient underwent lab tests and procedures which included Covid test Nasal Swab post vaccination on 26Feb2021 indicated Negative. The patient died on 26Feb2021. An autopsy was not performed. information on the lot/batch number has been requested.; Sender's Comments: Pulmonary edema, low heart rate, and chest pain, all reported as fatal, are deemed unrelated to BNT162B2 vaccine, being rather accidental occurrences, likely favored by the patient's age and by the mentioned high blood pressure, known risk factor for cardiovascular diseases. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Low heart rate; pulmonary edema; chest pain",Yes,02/26/2021,Not Reported,Yes,1.0,Not Reported,N,01/28/2021,02/26/2021,29.0,SEN,CARDIZEM [DILTIAZEM HYDROCHLORIDE]; ARIMIDEX; SIMVASTATIN; LORAZEPAM,,Medical History/Concurrent Conditions: Blood pressure high; COVID-19; Dementia,,,"['Chest pain', 'Heart rate', 'Heart rate decreased', 'Pulmonary oedema', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,OT 1073701,MS,68.0,F,"Got home on Saturday morning, no problem after having the shot. Sunday noticed a rash on trunk. Treated herself with Benadryl. Got worse over the next few days, belly, back, groin and armpit. Went to ER, started IV, Solumedrol, Benadryl, Prevacid, followup with pcp. Seemed to get better. Today, it's worse. . PCP stated if not better she is to go into the office for an injection.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/27/2021,02/28/2021,1.0,OTH,no,no,"COPD, CHF, Diabetes",,no,['Rash'],2,MODERNA,IM 1073703,,40.0,F,"PT ARRIVED IN OBSERVATION AREA, AND STATED THAT SHE FELT TINGLING AROUND HER LIPS. VS WERE INITIATED. 3:52PM HR 90 BP 126/64 O2 96%. MONITIORED VS EVERY TEN MINUTES. PT WAS ADMINESTERED 25 MG OF DIPHEHYDRAMINE 0.5 ML AT 4:05PM. AT 4:30 PT STATED THAT THEY STILL FELT TINGLING. ANOTHER DOSE OF 25MG OF DIPHENHYDRAMINE WAS ADMINESTERED. MONITORED PATIENT FOR AN ADDITIONAL 30 MINUTES. PT WAS ESCORTED BY SPOUSE STABLE.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,OTH,,,,,NKA,['Paraesthesia oral'],1,JANSSEN,IM 1073711,PA,22.0,M,status Epilepticus,Not Reported,,Yes,Yes,,Not Reported,U,02/05/2021,02/20/2021,15.0,PUB,Onfi Lamotrigine Briviact Epidiolex Vitamin D omprezole lactulose melatonin miralax senna probiotic flonase,None Known,"Epilepsy, spastic CP, Severe intellectual disabilities",seizure ( received Tranxene Bridge),Reglan Servoflurane,"['Endotracheal intubation', 'Rehabilitation therapy', 'Status epilepticus']",1,MODERNA,IM 1073735,,90.0,F,Patient arrived at observation area after getting vaccine at 5:40 PM. Patient complained of SOB and feeling unwell. V/S taken. Patient feels fine after sitting for 10 minutes.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,PUB,,,,,,"['Dyspnoea', 'Malaise']",1,JANSSEN,IM 1073752,CA,68.0,F,On February 24 and 25 and 26 my hands and feet swelled on the 27th my left hand turned purple and very inflamed,Not Reported,,Yes,Not Reported,,Not Reported,N,02/23/2021,02/24/2021,1.0,OTH,Saxagliptin/metformin 5/1000 azilsartan medoxomil 40mg levothyroxine sodium 100 mg nitrofurantoin 100 mg allopurinol300 choline fenofibrate 135 mg pregabalin75 mg clopidogrel 75 mg omega 3 vit E vitD3 vit C,No,Diabetes mellitus hypertension hypothyroidism renal failure uric acid high triglycerides diabetic neuropathologies,,No,"['Brachiocephalic vein thrombosis', 'Inflammation', 'Peripheral swelling', 'Skin discolouration', 'Ultrasound Doppler abnormal']",1,MODERNA, 1073754,UT,32.0,M,"About 5 hours after my vaccine, I experienced right arm soreness, I could not eat anything, very nauseous and my stomach was super sick. I went to the hospital because I felt I was going to throw up and I had to hold on to my stomach, felt a stabbing sensation to my stomach and the pain was unbearable. They performed an ultrasound of the abdomen and a CT scan of the abdomen. I also had an endoscopy performed after my 2nd vaccine. I had a biopsy of my stomach and I am pending results.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/31/2020,01/06/2021,6.0,PUB,"Cymbalta, Gabapentin, Topromax",,,,"Codeine, Naproxen","['Abdominal pain upper', 'Biopsy abdominal wall', 'Biopsy stomach', 'Computerised tomogram abdomen', 'Decreased appetite', 'Endoscopy', 'Injection site pain', 'Nausea', 'Pain in extremity', 'Ultrasound abdomen']",1,MODERNA,IM 1073773,CA,89.0,M,Patient was found deceased later in the afternoon.,Yes,03/02/2021,Not Reported,Not Reported,,Not Reported,N,03/02/2021,03/02/2021,0.0,MIL,"galantamine, atorvastatin",,"Alzheimer's/Dementia, BPH, HLD, HTN, Aortic stenosis, Osteopenia, allergic rhinitis",,penicillin,['Death'],1,MODERNA,IM 1073774,MN,68.0,F,"Patient is a 68 y/o female who enrolled in program on 9/19/2018 who began monotherapy treatment with Pioglitazone 15mg PO on 10/5/2018. Patient called study team stating that she received her second Pfizer COVID-19 vaccination on 02/19/21. Afterwards, she had a sore arm and slept most of the next day. On 02/21/21, she experienced severe right-sided leg weakness and fell while attempting to go to the bathroom. She was unable to ambulate and her son took her to the emergency room. She was hospitalized overnight for a serious adverse reaction to the second Pfizer COVID-19 vaccination. Multiple sclerosis exacerbation was ruled out after extensive testing. Then, she was transferred a Rehab facility on 02/22/21 for physical therapy and occupational therapy. She continues study medication without any missed doses. She will most likely be in Rehab for another week. She was able to walk 80 feet on 2/25/2021 with a walker and gait belt and ambulatory assistance. This is unrelated to study drug. We consider this to be a Non-UP SAE. As of 3/4/2021 the patient is still in rehab.",Not Reported,,Not Reported,Yes,11.0,Not Reported,N,02/19/2021,02/21/2021,2.0,PUB,Gabapentin 600mg 2 times a day PO Hyaluronic acid (for joint pain) 1 tablet Daily in AM PO MVI 1tab Daily in AM PO Ampyra (generic version) 10mg Daily in AM PO Vitamin D3 2500 international units. 4 times a week PO Citracal,"Irritable bladder/neurogenic (self caths), osteoporosis, foot parasthesias, Multiple sclerosis","Irritable bladder/neurogenic (self caths), osteoporosis, foot parasthesias, Multiple sclerosis",,none,"['Fall', 'Gait inability', 'Limb discomfort', 'Muscular weakness', 'Occupational therapy', 'Pain in extremity', 'Physiotherapy', 'Somnolence', 'Vaccination complication', 'Walking aid user']",2,PFIZER\BIONTECH, 1073803,MI,94.0,F,"Covid Brain: onset dementia, fatigue, muscle aches,",Not Reported,,Not Reported,Not Reported,,Yes,N,01/22/2021,01/25/2021,3.0,OTH,Morning: take 1 hour before eating! LEVOTHYROXINE 75MG 1 - Purple pill in white pill box MORNING DILTIAZEM (180MG!) 1 ZOLOFT (SERTRALINE) 25MG 1,none,old age,,none,"['Dementia', 'Fatigue', 'Myalgia']",2,MODERNA,SYR 1073807,UT,72.0,M,blood clots on lungs 2 days in hospital on blood thinner for the last 10 days,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/11/2021,02/17/2021,6.0,PUB,hydrochlorothiazide prednisone levetiracetam,,high blood pressure arthritis seizures,,,['Pulmonary embolism'],UNK,MODERNA, 1073808,CA,72.0,M,Prt was found deceased,Yes,03/04/2021,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/04/2021,0.0,PVT,"Amlodipine, Carvedilol, Aspirin, Atorvastatin, Duolextine, Norco, Gabapentin, Potassium, Flomax, Claritin, Ibuprofen","PTSD, H/O AAA, HTN, Afib, hemiplegia secondary to CVA, depression","PTSD, H/O AAA, HTN, Afib, hemiplegia secondary to CVA, depression",,None,['Death'],2,MODERNA,IM 1073812,,82.0,M,DEATH Narrative: PT WAS PLACED ON HOSPICE ON 1/21/2021,Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,01/23/2021,24.0,OTH,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1073813,,96.0,M,DEATH Narrative: UNCLEAR WHY PATIENT WAS HOSPITALIZED AS LIMITED INFORMATION IN RECORD,Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,12/31/2020,02/05/2021,36.0,OTH,,,,,,['Death'],1,MODERNA,IM 1073814,,91.0,M,DEATH Narrative: NO ADDITIONAL DETAIL PROVIDED OTHER THAN PATIENT DIED AT HOME,Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,02/07/2021,19.0,OTH,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1073815,,78.0,M,"DEATH Narrative: NO DETAILS PROVIDED, NO NOTE REGARDING DEATH",Yes,01/14/2021,Not Reported,Not Reported,,Not Reported,N,12/31/2020,01/14/2021,14.0,OTH,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1073816,,85.0,M,RESPIRATORY FAILURE Narrative: PT PASSED AWAY WHILE IN THE HOSPITAL,Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,N,01/09/2021,02/14/2021,36.0,OTH,,,,,,"['Death', 'Respiratory failure']",1,PFIZER\BIONTECH,IM 1073828,CA,87.0,M,Blood pressure went up 150-220,Not Reported,,Not Reported,Yes,,Not Reported,Y,03/01/2021,03/04/2021,3.0,PVT,"Losartan, Simvastatin",no,High Blood Pressure,,no,"['Blood pressure increased', 'Blood test', 'Electrocardiogram']",2,MODERNA,IM 1073841,IL,69.0,F,"A day after the vaccine, she experienced shortness of breath. This worsened and as a result, triggered a COPD episode which also led to Tachycardia. Her heart rate was 170 and she could not breath. She had to be rushed to the hospital in an ambulance.",Not Reported,,Yes,Yes,,Not Reported,N,03/01/2021,03/02/2021,1.0,PUB,"Entresto, blood pressure pill, Symbicort, albuterol, water pill I drank one cup of Ginger and tumeric herbal tea",None,COPD; Tachycardia I have a defibrillator,,None,"['Chronic obstructive pulmonary disease', 'Condition aggravated', 'Dyspnoea', 'Respiratory arrest', 'Tachycardia']",2,PFIZER\BIONTECH,SYR 1073850,WA,33.0,F,"13 minutes after injection- tongue tingling and numbness for 3 hours. Hot flashes, feeling hot, headache, and extreme fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,UNK,Gabepentin Tizanadine Ropenerole,No,Pcos Endometriosis Back and neck injuries,,No,"['Fatigue', 'Feeling hot', 'Headache', 'Hot flush', 'Hypoaesthesia oral', 'Paraesthesia oral']",1,JANSSEN,SYR 1073895,WA,77.0,M,Patient passed away after getting the 1st dose of COVID vaccine. He seemed otherwise very healthy.,Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/22/2021,25.0,PHM,,,,,,['Death'],1,MODERNA,IM 1073902,WA,80.0,F,Patient seemed otherwise healthy before the vaccination. Patient was hospitalized then shortly passed after getting the 1st dose.,Yes,03/04/2021,Not Reported,Yes,,Not Reported,N,01/29/2021,02/25/2021,27.0,PHM,,,,,,['Death'],1,MODERNA,IM 1073937,,49.0,F,Started to experience anxiety and dizziness approx 1 hour after receiving vaccine. BP elevated at time of observation (168/102). Obesrvation time extended to 1.5 hours. Provided hydration and light meal. Discharged per team member request after she stated she felt better. Encouraged to take BP meds as directed per PCP. Encouraged to go to ER for symptom return or additional adverse reactions per handout/Agency guidelines.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,WRK,,,,,,"['Anxiety', 'Blood pressure increased', 'Dizziness']",UNK,JANSSEN,IM 1073952,,74.0,M,"new onset severe thrombocytopenia, unexplained by extensive hospital work-up by hemotologist",Not Reported,,Yes,Yes,8.0,Not Reported,Y,02/01/2021,02/04/2021,3.0,SEN,,UTI with sepsis,"dementia, htn, obesity",,"Ciprofloxacin, Erythromycin, Heparin, NSAIDs","['Platelet count decreased', 'Thrombocytopenia']",1,PFIZER\BIONTECH,IM 1074003,AZ,21.0,M,"Vaccine was Moderna COVID-19 Vaccine EUA 4 days after receiving the vaccine, two hours after I woke up, I began to have mild chest pain in the center of my chest. After that, the pain started to grow and grow until it was extreme pain, at around an 8/10. The pain radiated from my chest to the undersides of my arms. After two hours of pain, it started to subside and eventually was gone. There was no pain for the rest of the day. The next day, two hours after I woke up again, the mild chest pain returned. Still in the center of my chest, the pain grew into extreme pain again. This time however, it was slightly to the right and as the pain progressed it moved right until after two hours it went away again. The treatment I got at the Urgent Care was an EKG and they told me to go to a hospital. At the hospital, I got Toradol, aspirin and propanolol. My initial Troponin levels at admission to the hospital were 900 and grew to 1300. It lowered for a time, but at the last check, it rose again to 1420 after not getting Toradol for at least 12 hours.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/27/2021,03/03/2021,4.0,SCH,,Hashimoto Thyroiditis,Hashimoto Thyroiditis,,"Amoxycillin, Augmentin","['Blood test', 'Blood thyroid stimulating hormone', 'Chest pain', 'Differential white blood cell count', 'Electrocardiogram ST segment elevation', 'Electrocardiogram abnormal', 'Full blood count', 'Laboratory test', 'Metabolic function test', 'Myocardial ischaemia', 'Pain', 'Pain in extremity', 'SARS-CoV-2 test', 'Troponin T increased']",1,MODERNA,SYR 1074009,MO,62.0,M,"Patient received the vaccine and was observed in the post vaccination area for 30 minutes. He then went upstairs to his apartment and returned approximately one hour later. He sat in the lobby and looked somewhat ill. He was questioned by house staff and said that he was ok. He then lost consciousness and slumped in his chair. Medical staff was notified and he was still unresponsive. He was lowered to the floor and upon assessment, he had no pulse or respirations. CPR was begun with bag mouth ventilation and subsequently chest compressions. He received 50mg of IM Benadryl and 40mg of Solu Medrol IM. He still had no pulse and he an AED pads were applied. AED analysis indicated a shockable rhythm and one shock was administered with return of pulse. He remained unconscious and ventilation was continued until EMS arrived.",Not Reported,,Not Reported,Yes,,Not Reported,U,03/04/2021,03/04/2021,0.0,OTH,Unknown,No acute illnesses,"coronary heart disease, diabetes",,Seasonal allergies,"['Cardioversion', 'Heart rate', 'Loss of consciousness', 'Pulse absent', 'Respiratory arrest']",1,PFIZER\BIONTECH,IM 1074011,CT,85.0,F,"Presented to ED 48 h after vaccine with chest pain, found to have pericarditis Develop atrial fibrillation, nSTEMI from demand ischemia",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/28/2021,01/30/2021,2.0,PVT,"acetaminophen (TYLENOL) 500 MG � � � allopurinoL (ZYLOPRIM) 300 mg tablet T amoxicillin-clavulanate (AUGMENTIN) 500-125 mg per tablet T aspirin 81 mg EC delayed release tablet � � � calcium carbonate-vitamin D3 600 mg(1,500mg) -800 unit T","Admitted with septic shock 1/3/21, BC negative. Rapidly improved","CAD s/p MI, HTN, PVD s/p aorto-iliac bypass graft (1983), fem-fem bypass for occlusion of left limb of graft (1993), left axillo femoral bypass graft (2003) complicated by aortic graft infection from likely aorto-enteric fistula (2018) now on chronic antibiotic suppression Celiac disease",,None,"['Acute myocardial infarction', 'Atrial fibrillation', 'Chest pain', 'Myocardial ischaemia', 'Pericarditis', 'Troponin increased']",1,PFIZER\BIONTECH,IM 1074050,TX,66.0,M,"2-19-2021 Received 1st Covid Injection 2-20-2021 Gasping for Air , LBP, EKG, transported via ambulance 2-21-2021 Admitted to Hospital LBP, EKG 2-22-2021 Surgery in which a pacemaker was installed",Not Reported,,Not Reported,Not Reported,,Yes,Y,02/02/2021,02/19/2021,17.0,PHM,,"Jan 5, 2021 tested positive with no symptoms. Feb. 18, 2021 LBP - pulse 40-50 Feb. 19, 2021 LBP, -pulse 40's Feb. 20, 2021, LBP, pulse 40's, Developed extreme gasping for air, an ambulance was called and EKG was abnormal Feb. 21,2021, Admitted to Hospital Feb. 22, 2021 Surgery and a Pacemaker was installed., some fluid on lung","HBP, Diabetes, HHT Blood Disorder",,Latex,"['Back pain', 'Bradycardia', 'Cardiac pacemaker insertion', 'Dyspnoea', 'Electrocardiogram abnormal', 'Heart rate decreased', 'Hypotension', 'Pulmonary oedema']",1,MODERNA,SYR 1074067,MI,67.0,M,Patient received Moderna COVID-19 vaccine on 2/25/2021. Patient found dead by family the morning of 2/26/2021. Family requested an autopsy.,Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,N,02/25/2021,02/26/2021,1.0,PVT,"albuterol, ammonium lactate cream, eliquis, aspirin, lipitor, clozaril, decadron, fluticasone, zyprexa, zofran, senokot, zoloft, flomax, spiriva",kidney / bladder cancer with extension into soft tissue inferior vena cava clot extending to liver,"atherosclerosis, history of CVA, history of stage 1 squamous cancer of LUL, LU lobectomy, sleep apnea, emphasema, tardive dyskenesia, squamous cell cancer skin, constipation, schizoaffective disorder, hyperlipidemia",,none,['Death'],UNK,MODERNA,SYR 1074076,HI,56.0,M,"Patient received 2nd covid-19 vaccine on 3/2 and day after had acutely altered mental status along with fever of 104 as measured by EMS. He reported feeling very weak and was found crawling in dirt outside. Was brought to hospital and T was 102, also found to have acute kidney injury on CKD. Fever resolved with tylenol and pt was treated supportively with IV fluids with improvement in mental status and resolution of fever. Weakness still present day after admission.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,03/02/2021,03/03/2021,1.0,PVT,"Lithium, olanzapine, amlodipine, losartan, levothyroxine, fenofibrate, methotrexate, acetaminophen, folic acid, propranolol",,"Schizophrenia, HTN, CKD3, psoriasis",,No known allergies,"['Abnormal behaviour', 'Acute kidney injury', 'Asthenia', 'Blood creatinine increased', 'Chronic kidney disease', 'Mental status changes', 'Pyrexia', 'SARS-CoV-2 test negative', 'White blood cell count increased']",2,MODERNA,IM 1074103,WA,36.0,F,"I initially had itchiness at injection site, then more of my arm. At 15 minutes I talked with the nurse, she looked at and we talked for quite a bit what I should do but I was feeling just fine and left to go home and take benedryl. I had just left the hospital (25 mins post shot) and my throat and tongue started swell rapidly. I called 911 and the county rescue responded. My breathing was normal by then. My body has been itchy all over since then and my throat remains minor swollen. I did not get an epi shot since I was mostly okay and the EMTs were convinced I had a panic attack so I just went home.",Not Reported,,Yes,Not Reported,,Not Reported,Y,03/03/2021,03/03/2021,0.0,PVT,Lexapro and trazadone; sumatriptan,None,None,Smallpox,None. I had a bad reaction to my smallpox vaccine,"['Blood pressure increased', 'Heart rate increased', 'Injection site pruritus', 'Panic attack', 'Pharyngeal swelling', 'Pruritus', 'Swollen tongue']",1,PFIZER\BIONTECH,SYR 1074118,TX,53.0,M,Renal artery blood clot causing renal infarction,Not Reported,,Not Reported,Yes,7.0,Yes,Y,02/10/2021,02/19/2021,9.0,PHM,"Zyrtec, nasacort, tylenol, ibuprofen",None,Seasonal allergies,,None,"['Computerised tomogram abdomen', 'Renal embolism', 'Renal infarct']",2,MODERNA,IM 1074142,GA,69.0,F,"Severe sore throat; sinus congestion; non-productive cough; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (Lot number: El9267), via an unspecified route of administration on 10Feb2021 14:15 at single dose in the left arm for COVID-19 immunization. Medical history included osteoarthritis from an unknown date. Concomitant medication included spironolactone. On 11Feb2021 08:00, the patient experienced severe sore throat, sinus congestion and non-productive cough. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/11/2021,1.0,OTH,SPIRONOLACTONE,,Medical History/Concurrent Conditions: Osteoarthritis,,,"['Cough', 'Oropharyngeal pain', 'Sinus congestion']",1,PFIZER\BIONTECH, 1074149,,,F,"Miscarried at 6 weeks; Vaccine exposure during pregnancy; A spontaneous report was received from a healthcare professional concerning a 32 year old female patients who received Moderna's Covid 19 vaccine(mRNA1273) and experienced vaccine exposure during pregnancy and miscarried at 6 weeks. The patient's medical history was not provided. Concomitant product use was not provided. The patient received second of two planned dose of mRNA-1273 for prophylaxis of Covid 19 infection approximately 2.5 weeks before the miscarriage. The patient experienced vaccine exposure during pregnancy and miscarried at 6 weeks, approximately 2.5 after receiving her second dose of Moderna vaccine. The patient received both scheduled doses of mRNA-1273 prior to the events ; therefore, action taken with the drug in response to the events is not applicable. The outcome of the event, miscarriage spontaneous was considered as unknown. The outcome for the event of Vaccine exposure during pregnancy was recovered/resolved.; Reporter's Comments: This case concerns a 32 year old, female subject, who experienced a spontaneous abortion and drug exposure during pregnancy. The patient experienced vaccine exposure during pregnancy and miscarried at 6 weeks, approximately 2.5 after receiving her second dose of mRNA-1273. Very limited information has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Abortion spontaneous', 'Exposure during pregnancy']",2,MODERNA,OT 1074150,IL,,M,"septic right knee; A spontaneous VAERS report was received from a reporter ( healthcare professional) concerning a 76 year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced serious event septic right knee (PT-Arthritis bacterial). The patient's medical history was not provided. The patient received first dose of vaccine (Lot number:039K20A) on 30-Dec-2021. The relevant concomitant medications were also not provided. On 26-Jan-2021 , prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 019K20A) through intramuscular route of administration in the right arm for prophylaxis of COVID-19 infection. On 17-Feb-2021, the patient experienced septic right knee and was admitted to the hospital and treatment was provided ( treatment details are not provided). Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event was not provided.; Reporter's Comments: This is a case of a 73-year-old male subject with limited hx and experienced septic right knee 23 days after receiving second dose of vaccine. Very limited information regarding these events have been provided at this time. However, based on the onset date and cause of infection due to bacterial organism, the event is unlikely related to the vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/26/2021,02/17/2021,22.0,SEN,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Arthritis bacterial'],2,MODERNA,OT 1074151,,71.0,M,"double pneumonia; A spontaneous report was received from a healthcare professional concerning a 71-year-old, male patient who received a Moderna's COVID-19 vaccine (mRNA-1273) second dose. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included lisinopril, terazosin, clopidogrel, atorvastatin. On 13-Feb-2021 prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. Caregiver reported on spouse's symptoms following dose 2 of vaccine. On 13-Feb-2021, after second dose of vaccine, patient experienced slight fever of 99.2 Fahrenheit, joint pain, and typical cold symptoms. On 14-Feb-2021, patient felt fatigues and slight fever. On 15-Feb-2021, patient felt not right. On 17-Feb-2021, early morning, fever was 99.8 Fahrenheit, and he sounded like has fluid overload. Called ambulance because patient felt like he could not breathe. At hospital oxygen saturation was 67%. Polymerase chain reaction COVID-19 test was negative. Patient got admitted to intensive care unit. No treatment information was provided. The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events, double pneumonia, felt like he couldn't breathe, feeling not right, fever, typical cold symptoms, joint pain, and fatigue were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/13/2021,02/17/2021,4.0,UNK,TERAZOSIN; LIPITOR; PLAVIX; LISINOPRIL,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Body temperature', 'Oxygen saturation', 'Pneumonia', 'Polymerase chain reaction']",1,MODERNA,OT 1074152,,,F,"Severe Abdominal pain; A spontaneous report, was received from a consumer, concerning a female patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced severe abdominal pain (abdominal pain). The patient's medical history was not provided. Concomitant medication was not reported. On 12 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscular for the prophylaxis of COVID-19 infection. On 13 Feb 2021, the patient experienced severe abdominal pain and visited emergency room (ER) and stayed there for 7 hours. On 18 Feb 2021, the patient was re-hospitalized and stayed for 25 hours. No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the event was not provided. The outcome of the event, severe abdominal pain, was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/12/2021,02/13/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history provided.),,,['Abdominal pain'],1,MODERNA,OT 1074153,OK,82.0,F,"Bell's Palsy; A spontaneous report was received from a consumer concerning an 82-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA1273) and developed Bell's palsy and experienced pain and burning in eyes and a severe headache. . The patient's medical history includes heart disease. Products known to have been used by the patient, within two weeks prior to the event, included clopidogrel bisulfate. The patient received first of two planned dose of mRNA-1273 (Batch Number 041L20A) intramuscularly on 14-JAN-2021 for prophylaxis of Covid-19 infection. On 18-FEB-2021, it was reported that the patient had eye pain and some symptoms of Bell's Palsy. On 19-FEB-2021, the symptoms worsened and so on 20-FEB-2021, the patient was taken to urgent care where she was diagnosed with Bell's palsy. The left side of the patient's face, according to her husband, was drooping and she was having trouble eating and drinking. The patient also had a severe headache. Treatment for the event included prednisone. Patient was also wearing a patch to help prevent pain. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, Bell's palsy was considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,02/18/2021,35.0,UNK,CLOPIDOGREL,"Heart disease, unspecified",,,,"[""Bell's palsy""]",1,MODERNA,OT 1074154,IL,63.0,F,"Shingles; Pain behind ear; Rash; Slight dropping in face on the side of vaccination; A spontaneous report was received from consumer concerning a 63 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events- Drooping of Face, Pain Behind Ear, Rash and Shingles. The patient's medical history was not provided. No relevant concomitant medications were reported. On 13 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030MZ0A) intramuscularly for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient noticed that she was experiencing slight dropping in her face on the side of the vaccination. The next day, on 17 Feb 2021, the patient began experiencing some pain behind her ear and a small rash on the same side. She was diagnosed with shingles on 22Feb2021. Treatment information provided include Allergy Pills, Tylenol, Prednisone, Anti-Bacterial medications. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event- Drooping of Face, Pain Behind Ear, Rash and Shingles was unknown.; Reporter's Comments: Based on the information provided and a temporal association between the reported events and the administration of mRNA-1273 vaccine, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/13/2021,02/16/2021,3.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history provided),,,"['Ear pain', 'Facial paralysis', 'Herpes zoster', 'Rash']",1,MODERNA,OT 1074155,CA,72.0,M,"Loss of consciousness; cardiologist assumes cardiac arrhythmias; Vertigo; Sweating; Nausea; pain in the shoulder; A spontaneous report was received from a physician concerning a 72 year old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shoulder pain (arthralgia), loss of consciousness, vertigo, nausea, sweating (hyperhidrosis) and cardiologist assumes cardiac arrhythmias(arrhythmias). The patient's medical history included myocardial infarction and stent. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (Batch number: 004M20A) on 29 Jan 2021 intramuscularly in his left arm for prophylaxis of COVID-19 infection. On 29 Jan 2021, the patient experienced shoulder pain. On 08 Feb 2021, the patient experienced loss of consciousness, vertigo, nausea, sweating and cardiac arrhythmias. Treatment information was not provided. Laboratory data includes MRI, CT scan, X-RAYs and blood flow of carotids. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, shoulder pain was resolved on 31 Jan 2021 and loss of consciousness, vertigo, nausea, sweating, cardiac arrhythmias were considered unknown.; Reporter's Comments: This case concerns an 72 year old, male patient, with medical history of MI and stent placement, who experienced a serious unexpected event of Asthenia, confusional state, and impaired self-care, 11 days after receiving 1st dose of mRNA- 1273 (Lot# 004M20A). Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Myocardial infarction; Stent placement,,,"['Arrhythmia', 'Arthralgia', 'Carotid pulse', 'Computerised tomogram', 'Hyperhidrosis', 'Loss of consciousness', 'Magnetic resonance imaging', 'Nausea', 'Vertigo', 'X-ray']",1,MODERNA,OT 1074156,IN,88.0,F,"Bell's palsy; A spontaneous report was received from a Consumer concerning an 88-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (Batch number: 013L20A) intramuscularly for prophylaxis of COVID-19 infection on 11 Jan 2021. On 08 Feb 2021, approximately 11 days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly in right arm for prophylaxis of COVID-19 infection. On 19 Feb 2021, the patient was diagnosed with Bell's palsy. Treatment details, as reported by the reporter, included prednisone. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event, Bell's Palsy was unknown on 23 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of Bell's palsy, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/11/2021,02/19/2021,39.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"[""Bell's palsy""]",1,MODERNA,OT 1074157,,,M,"COVID-19; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID-19. The patient's medical history was not provided. Concomitant medication was not provided by the reporter. On 08 Jan 2021, approximately thirteen days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. The patient was diagnosed with COVID-19 on 20 Jan 2021. On an unknown date the patient was hospitalized and on 30 Jan 2021 the patient was released from the hospital. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event was not reported.; Reporter's Comments: This case concerns a male of unknown who was hospitalized with a serious unexpected event of COVID-19. The event occurred 13 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/08/2021,01/20/2021,12.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['COVID-19'],1,MODERNA,OT 1074158,TX,,F,"Round red mark on the injection site; A spontaneous report was received from a consumer, concerning a 97-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed round red mark on the injection site/vaccination site erythema. The patient's medical history was not provided. No concomitant product use was provided. The patient received their first of two planned doses of mRNA-1273 (batch number: not provided) on an unspecified date. On 01 Feb 2021, approximately 5 days, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 010M20A) intramuscularly for prophylaxis of COVID-19 infection. On 06 Feb 2021, post vaccination the patient developed a round red mark on the injection site. The seriousness criteria for the event round red mark on the injection site. Treatment information was not provided. The outcome of the event, round red mark on the injection site/ vaccination site erythema was considered unknown.; Reporter's Comments: This case concerns a 97-year-old female who had a medically significant and serious expected event of Vaccination site erythema. The events occurred 5 days after the second dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/06/2021,5.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Vaccination site erythema'],1,MODERNA,OT 1074159,IA,59.0,F,"Injection site swelling; Numbness on the left side of the face; Left facial tingling; A spontaneous report was received from a Health Care Professional concerning a 59-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling on the left side of the face, numbness on the left side of the face and swelling on left arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On 06 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (0Batch Number: 25L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 06 Jan 2021, the patient experienced tingling and numbness on the left side of the face and subsided after 3hrs. On 07-JAN-2021, the patient experienced swelling on left arm that got worse for over 2 weeks before it goes away. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events tingling and numbness on the left side of the face was considered resolved(subsided after 3hrs) on 06 Jan 2021. The outcome of event swelling on left arm that got worse for over 2 weeks before it goes away was considered resolved.; Reporter's Comments: This case concerns a 59-year-old female who experienced serious unexpected events of Hypoaesthesia along with a NS unexpected event of Paraesthesia and NS expected event of Vaccination site swelling. The events occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-024023:Crosslink case - same reporter US-MODERNATX, INC.-MOD-2021-024023:Crosslink case - same reporter",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/06/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Hypoaesthesia', 'Paraesthesia', 'Vaccination site swelling']",2,MODERNA,OT 1074160,MI,87.0,M,"Could not get out of bed as he lost function of his legs and they would not work; A spontaneous report was received from a consumer, concerning her husband, a 87-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and could not get out of bed as he lost function of his legs and they would not work. The patients' medical history and concomitant medication details were not reported. On 07-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via intramuscular route in left arm upper arm for prophylaxis of COVID-19 infection. On 07-Jan-2021, after the first dose of vaccine, the patient could not get out of his bed as he lost function of his legs and his legs would not work. Hence, he was taken to hospital on 07-Jan-2021 and was discharged on 10-Jan-2021. The patient's wife reported that the treating physician did not determine the cause of the patient's symptoms. On 04-Feb-2021, the patient received second of two planned doses of mRNA-1273 (lot/batch: unknown) via intramuscular route in left arm upper arm for prophylaxis of COVID-19 infection. On 04-Feb-2021 following the second dose of the vaccine, he could not get out of bed, legs would not work. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the events Could not get out of bed as he lost function of his legs and they would not work was considered resolved on an unspecified date in 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-030097:Same patient, 2nd dose",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Musculoskeletal disorder'],2,MODERNA,OT 1074161,CA,,M,"Pleurisy/Pleuritis; A spontaneous report was received from a Consumer concerning a 51 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pleurisy. The patient's medical history was not provided. Relevant concomitant medications were not reported. On 08 JAN 2021, approximately 4 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the Left Deltoid for prophylaxis of COVID-19 infection. He received the vaccine on 08 JAN 2021 and the pain developed 3 days after the vaccination. He received this first dose in his left deltoid. The chest cavity pain was on his left side. The pain lasted for 6-7 days. On 11 JAN 2021, the patient diagnosed with Pleurisy which is a medically important event and intervention was required. Laboratory details were provided as Chest X-ray, Echocardiogram, Electrocardiogram, Troponin normal and the results were reported as normal. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. On 11 JAN 2021, the outcome of the event Pleurisy was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/08/2021,01/11/2021,3.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Chest X-ray', 'Echocardiogram', 'Electrocardiogram', 'Pleurisy', 'Troponin normal']",1,MODERNA,OT 1074162,NY,,F,"she was underage; arm was sore; A spontaneous report was received from a 17-year-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was sore/vaccination site pain, and she was underage/inappropriate age at vaccine administration. The patient's medical history was not provided. No concomitant product use was reported. On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 16-Jan-2021, the patient reported that her arm was sore for 2 days. On an unspecified date, the patient reported that she did not receive her second vaccination as she was underage. Action taken with mRNA-1273 was unknown. The outcome of the event, arm was sore/vaccination site pain was resolved on 18 Jan 2021. The outcome of the event, she was underage/inappropriate age at vaccine administration was resolved on 15 Jan 2021.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration and vaccination site pain for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start of vaccination site pain, a causal relationship cannot be excluded. The causality for inappropriate age at vaccine administration is assessed to be not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/16/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Product administered to patient of inappropriate age', 'Vaccination site pain']",1,MODERNA,OT 1074163,TN,77.0,F,"tiny sore in her arm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN5318, expiry date unknown), via an unspecified route of administration on 23Jan2021 at 16:00 at a single dose on the left arm for COVID-19 immunization. Medical history included back surgery on an unknow date and back pain from an unknown date. Concomitant medication included paracetamol (TYLENOL) for back pain from back surgery. The patient reported that her doctor prescribed Tylenol to ease the back pain after a back surgery that she had before. She is prescribed to take the Tylenol 4 times a day at 6 hour intervals. She stated that she read something about after taking the COVID vaccine to not take Tylenol. At the time of the report she is feeling good with no side effects but based on the report she read that after, she is not supposed to take anything, she wanted to ask will it affect the effectivity as she read in a literature that Tylenol will decrease the efficacy of the COVID vaccine. She was wondering if it is ok for her to continue to take Tylenol. The patient also reported that she only had a tiny sore in her arm on an unspecified date in 2021. She was scheduled for the second dose on 13Feb2021. The outcome of the event was unknown. The events were reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,,,UNK,TYLENOL,,Medical History/Concurrent Conditions: Back pain; Back surgery,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1074164,CT,83.0,F,"injection site redness; injection site soreness/injection site tenderness; Injection site itching; swelled up a little bit; This is a spontaneous report from a contactable consumer (patient). This 83-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL9263), via an unspecified route of administration on 27Jan2021 10:35 at single dose in the left arm for COVID-19 immunization. The patient's medical history included diabetes, thin blood, heart, kidneys, allergic to shellfish. Family history included heart and kidney problems. The patient's concomitant medications included metformin (GLUCOPHAGE) for diabetes for 25 years, metoprolol succinate for heart for 3 years, furosemide for 3 years, acetylsalicylic acid (ASPIRIN) for thin blood for five years, fenofibrate for heart for 3 years, colecalciferol (VITAMIN D) for kidneys for 3 years, and multivitamin to keep her healthy for a long time, all ongoing. Vaccination Facility Type was drive through. History of all previous immunization with the Pfizer vaccine considered as suspect: none. Additional vaccines administered on same date of the Pfizer suspect: none. The patient experienced injection site itching on 27Jan2021, injection site redness on 28Jan2021 and injection site tenderness on 28Jan2021. Clinical course reported as follow: patient had the first dose of the Pfizer BioNTech COVID-19 vaccine on 27Jan2021. On the night (27Jan2021) she got the first dose, she experienced injection site itching. Yesterday (28Jan2021), she experienced injection site redness. Last night (28Jan2021) at 20:00, she took a diphenhydramine hydrochloride (BENADRYL) and the itching stopped but she was still experiencing injection site redness and soreness. Clarified she received the first dose in the left arm. Added it was tender to touch. Patient was scheduled for the second dose on 17Feb2021 at 10:10. Patient stated when she got first shot she had some reaction to it, it wasn't that bad, it was itchy and it swelled up a little bit (Jan2021) and got real red. The adverse events did not require a visit to physician or ER. No prior vaccinations within 4 weeks. No relevant test. Outcome of injection site itching was recovered on 28Jan2021, outcome of injection site redness was not recovered, outcome of injection site soreness/injection site tenderness was recovering, outcome of other event was unknown. The report was assessed as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/01/2021,,UNK,GLUCOPHAGE [METFORMIN]; METOPROLOL SUCCINATE; FUROSEMIDE; ASPIRIN [ACETYLSALICYLIC ACID]; FENOFIBRATE; VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: Anticoagulant therapy; Diabetes; Heart disorder; Kidney disorder; Shellfish allergy,,,"['Vaccination site erythema', 'Vaccination site pain', 'Vaccination site pruritus', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 1074165,FL,,F,"Chills; Headache; Pain in her arm/arm is sore; joint pain; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team and also from a Pfizer Sponsored Program . A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/lot number: Unknown) via an unspecified route of administration on 26Jan2021 at 30 ug, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient received the first dose of the COVID vaccine on 26Jan2021. Her next appointment was scheduled 23Feb2021 (10 days in addition to 21 days). The patient had headache, chill and pain in her arm/arm is sore and joint pain after the first dose of COVID vaccine in Jan2021. Caller stated her chills have went away but was still getting a little bit of a headache and she had some pain in her arm in Jan2021, but it was much better now. The patient got the shot on the 26th and was given her second shot on 23Feb2021. The outcome of the event headache was not recovered, pain in her arm was recovering, chills was recovered on an unspecified date in 2021 and joint pain was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/01/2021,,UNK,,,,,,"['Arthralgia', 'Chills', 'Headache', 'Pain in extremity']",1,PFIZER\BIONTECH, 1074166,,,M,"headache; This is a spontaneous report from a contactable consumer. A male patient (father) of unknown age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 22Jan2021 at single dose for COVID-19 Immunization. Medical history and Concomitant medications were not reported. The patient received the first dose of the Covid vaccine on 22Jan2021. On the 3rd day (25Jan2021) developed a headache that has now lasted 5 days. further stated that it was getting better, but still not going away. The outcome of event was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/25/2021,3.0,UNK,,,,,,['Headache'],1,PFIZER\BIONTECH, 1074167,OK,65.0,F,"nausea; diarrhea; Could not lift her head because her eyes were hurting. When she opened them it gave her a headache; Feeling cold; chills; muscle pain; joint pain; fever; headache/Headaches was reported as worsened; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (also the age at vaccination) receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9263), via an unspecified route of administration at the left arm on 26Jan2021 11:00 AM SINGLE DOSE for covid-19 immunization (reported also as To protect herself). Medical history included that she had a heart cath under anesthesia about two weeks prior to getting the vaccine. She clarifies it was on 30Dec2020. There were no concomitant medications. There was no additional vaccines administered on same date. There was no prior vaccinations (within 4 weeks). No family medical history relevant to AE(s) reported. The patient was vaccinated at a Clinic. The patient previously had a flu shot in Oct2020 and the shingles vaccine in Aug2020 (for immunization). It was reported that the patient had headache, fever, chills, muscle pain, joint pain, nausea and diarrhea after the first dose of the pfizer covid 19 vaccine. The patient wanted to know how long these side effects will last. It was also asked if she should get the second dose of the covid 19 vaccine because she had side effects to the first dose and if the side effects to the second dose or worse than the first dose. It was further reported that the patient got her first shot last Tuesday (26Jan2021). Starting Friday (29Jan2021) she got symptoms. Should she be concerned? She has had tiredness, headaches, (on 27Jan2021) and this morning (01Feb2021) she could not lift her head because her eyes were hurting. When she opening them it gave her a headache. She also had muscle and joint pain (on 29Jan2021) and chills (on 30Jan2021) and fever (on 28Jan2021). She got so cold she covered up with blankets and fell asleep (on 01Feb2021). Then when she woke up it was gone. How long should these side effects last? Should she be concerned? Should she contact her doctor? The reporter also says that most of her symptoms started Friday 29Jan2021. Then she clarifies that actually her symptoms started small before then, on Wednesday 27Jan2021. As the week went on more symptoms came and became other things. It was added that she felt like Friday 19Jan2021 is when she felt the infusion all of a sudden hit her body. That is when she felt the virus hit her with symptoms. Right now her head still hurts. She is not taking as many Tylenol or staying on it regularly like she was. Maybe she should do that again. Could not lift her head because her eyes were hurting. When she opened them it gave her a headache: She says she still has dull pain behind her eyes. She no longer has chills but is feeling cold (on 01Feb2021). Like she chest was frozen on the same side that she got the shot in. They told her to take Tylenol to get relief. But she got concerned as the days went on. She is supposed to get the second dose on 16Feb2021. It was added that it was unknown specific times that these occurred. Friday she would say that she felt it all hit her bad around 11 AM after lunch. The outcome of the event headache, Muscle and joint pain was not recovered; for the event Could not lift her head because her eyes were hurting. When she opened them it gave her a headache and Feeling cold were recovering; for the event nausea, fatigue and diarrhea was unknown; and recovered for the events Chills on 31Jan2021, Fever on 29Jan2021. The AE(s) did not require a visit to Physician office nor ER. Case was considered as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,OTH,,,Medical History/Concurrent Conditions: Cardiac catheterisation,,,"['Arthralgia', 'Chills', 'Diarrhoea', 'Eye pain', 'Fatigue', 'Feeling cold', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1074168,CA,74.0,M,"Strong rash in different parts of my body. Arms, chest, lower back, buttocks, thighs/very painful; This is a spontaneous report from a contactable consumer (patient). This 74-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via an unspecified route of administration in the right arm on 26Jan2021 at 16:45 (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history included heart valve disease, with a new aortic valve and two bypasses from Jun2018 and unknown if ongoing; and allergy to sugar, dairy and wheat from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) from an unknown date for an unknown indication, and warfarin sodium 7.5 mg from an unknown date for an unknown indication. The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient reported that two days after receiving the first dose he had broken out in a strong rash in different parts of his body; arms, chest, lower back, buttocks, and thighs. He reported they were starting to settle down a bit now (as of 01Feb2021) but were very painful. The event was reported as non-serious, and did not require hospitalization. No treatment was provided for the event. The clinical outcome of strong rash in different parts of my body; arms, chest, lower back, buttocks, thighs, very painful was recovering. It was also reported the patient had not been tested for COVID-19 since vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/28/2021,2.0,PVT,BABY ASPIRIN; WARFARIN SODIUM,,"Medical History/Concurrent Conditions: Allergy (Allergies to medications, food, or other products:sugar, dairy, wheat); Aortic valve replacement (Heart valve disease, with a new aortic valve and two bypasses in June 2018); Bypass surgery (Heart valve disease, with a new aortic valve and two bypasses in June 2018); Heart valve disorders (Heart valve disease, with a new aortic valve and two bypasses in June 2018)",,,['Rash'],1,PFIZER\BIONTECH, 1074169,CA,65.0,F,"started feeling quite itchy at and around the area of the injection site in the upper left arm/It is a distinct tingly itchy sensation; . It has been pretty much continuous since yesterday and continues today. It is a distinct tingly itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 65-year old female non-pregnant patient received first dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: unknown) via unspecified route of administration, on left arm at 11:45, on 23Jan2021, at single dose for COVID-19 immunisation. The patient medical history included heart attack, high blood pressure, high cholesterol. The concomitant medication included carvedilol, rosuvastatin, glycine, glucosamine, colecalciferol (D3) and msm. The patient previously took tylenol and experienced allergies. It was reported that about a week after the injection on 30Jan2021, I started feeling quite itchy at and around the area of the injection site in the upper left arm (as reported). It has been pretty much continuous since yesterday and continues today (as reported). It is a distinct tingly itchy sensation. It was reported that patient didn't see anything unusual in this around the area of the injection site. The patient used cortisone which helped slightly. The patient was not sure if it was safe to take second dose. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she was not overweight at all. The outcome of the events was recovering Information on the lot/batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/30/2021,7.0,UNK,CARVEDILOL; ROSUVASTATIN; GLYCINE; GLUCOSAMINE; D3,,"Medical History/Concurrent Conditions: Blood pressure high (Heart attack, high blood pressure, high cholesterol but I am not overweight at all); Heart attack (Heart attack, high blood pressure, high cholesterol but I am not overweight at all); High cholesterol (Heart attack, high blood pressure, high cholesterol but I am not overweight at all)",,,"['Paraesthesia', 'Vaccination site pruritus']",1,PFIZER\BIONTECH, 1074170,IL,42.0,F,"chills; increased heart rate; poor sleep; fatigued; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247), via an unspecified route of administration in the right arm on 25Jan2021, at 12:15 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, at 12:15 the patient experienced chills, increased heart rate, poor sleep, and fatigued, which were non-serious. The patient underwent lab tests and procedures which included heart rate: increased on 26Jan2021. Details were as follows: hours after injection (just after midnight), the patient had chills, increased heart rate and poor sleep; next day she was fatigued and side effects subsided 24 hours after onset (midnight). The outcome of chills, increased heart rate, poor sleep, and fatigued was recovered in Jan2021, with no treatment No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/26/2021,1.0,PVT,,,,,,"['Chills', 'Fatigue', 'Heart rate', 'Heart rate increased', 'Poor quality sleep']",UNK,PFIZER\BIONTECH, 1074171,,,F,"headache; Fatigue; Flu like symptoms; This is a spontaneous report from a non-contactable consumer. A non-pregnant female patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 28Jan2021 at a single dose for COVID-19 immunization; administered in a nursing home/senior living facility. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's medical history included allergy from an unknown date and unknown if ongoing (allergies to medications, food, or other products: yes). Concomitant medications were not reported. On 28Jan2021, the patient experienced headache (non-serious), fatigue (non-serious), and flu like symptoms (non-serious). There was no treatment received for the adverse events. The clinical course was reported as follows: The patient had a headache for the last four days (at the time of the report); which started about three hours after receiving the vaccine. The patient was also very fatigued and experienced flu like symptoms since receiving the vaccine. The patient underwent lab tests and procedures which included COVID test post vaccination: pending results on 02Feb2021. The clinical outcome of the events was not recovered. No follow-up attempts are possible; information about batch/lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,SEN,,,"Medical History/Concurrent Conditions: Allergy (Allergies to medications, food, or other products:Yes)",,,"['Fatigue', 'Headache', 'Influenza like illness', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1074172,NC,73.0,M,"slight stiffness & tenderness in jab site; slight stiffness & tenderness in jab site; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 01Feb2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced slight stiffness & tenderness in jab site on an unspecified date, which were non-serious. Prior to vaccination, no diagnoses of COVID-19 was noted and since the vaccination, it was unknown if the patient was tested for COVID-19. The outcome of slight stiffness & tenderness in jab site was unknown; it was unknown if treatment was given for the events. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,,,PUB,,,,,,"['Musculoskeletal stiffness', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 1074173,FL,52.0,F,"aggravated and upset; she is angry; is miserable everyday/ felt like she was in a car accident, that is how bad she felt; cold chills; she runs low like 96.6 to 96.8 and she took her temperature/ she was 95.5; joint pain/joint hurting; restless leg syndrome; fatigue; she got sick; nauseous; threw up; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included seasonal asthma diagnosed when she was a child and has a rescue inhaler she only uses once in a while if she needs it; she stated her thyroid was giving her problem, she takes a thyroid medicine; and stated weight was thanks to menopause. Concomitant medications included ascorbic acid (VITAMIN C), fish oil (OMEGA 3), and curcuma longa (TURMERIC). The patient reported that she was aggravated and upset on an unspecified date. She reported that she was not feeling bad before taking the shot and nobody was telling her what to do about it. She was asking what she should do about her symptoms of joint pain, restless leg syndrome and fatigue after getting her first vaccination on 22Dec2020. She was crying and stated that her boss can't tell her anything, she doesn't want to go to her doctor because, what was he going to tell her. She doesn't want to waste a copay. She reported taking Advil and Tylenol for her joint pain without relief and asked what else she should do. She stated she wanted directions, she doesn't want people reading off of a card. She stated she shouldn't have to pay a copay and she doesn't want more medicine to mask her symptoms, she wanted an answer. Additionally, the patient was calling about Pfizer COVID shot, she took first dose 22Dec2020, had a reaction, 35 minutes after she sat for 30 minutes, she works at a hospital, and she walked out to her car, she got sick and nauseous, then after the shot, she had flu like symptoms that lasted, and the next day was terrible, it lasted another week and a half, then she took the second shot 11Jan2021, to this day, she still has restless leg syndrome, fatigue, and her joints were hurting her. She had the same thing before, but this hurts a lot worse, and it was not going away, she was taking Turmeric, everything, and everyone says to just keep taking Tylenol or Advil but she can't keep taking it because now it was upsetting her stomach, or like arthritis medicine, she was taking Omega 3, vitamins, she was 52 years old, she does Spartan races, Cross fit, she does paleo and keto eating, if one looks at her they wouldn't know she was 52, and she was hurting everyday and doesn't know what else do to, and doctors weren't knowledgeable, she doesn't want a stupid answer. She called work, the CDC knows about it, now VAERS, and they said to call Pfizer, when she calls her doctor she doesn't want to pay a copayment and get an idiotic answer. She got this because she works at a hospital and she was trying to protect herself and everyone else, she doesn't like feeling this way, it was to the point she was getting angry, not at Pfizer, but she gets up and runs, with her dog, she was busy all the time, she has 3 boys in the military, and she meets up to do obstacles with them, but she doesn't feel like doing crap and was miserable everyday. She was a CNA in nursing school. She doesn't know if she even wanted to see her doctor, she doesn't want to get an idiotic answer. She hasn't seen him in while, she switched insurance, been primary for years. Stated this was her first day speaking to DSU before she decides what else to do after this, she was angry. Stated about 35 minutes after the first shot, after 30 minutes they said she could go, she said ok, she walked out to her car, was nauseous and threw up and didn't eat that morning, and the next day, she felt like she was in a car accident, that was how bad she felt, she had cold chills, flu like stuff that night before, she runs low like 96.6 to 96.8 and she took her temperature, she got in a blanket and went to bed that night, she was 95.5, and didn't bother taking another temperature, she took a bunch of Advil and went to bed, and Benadryl to go to sleep. This all started on 22Dec2020, and it took about 2 weeks, she just had joint pain, not like now, but those days she didn't feel good, but by the third week she was ok, and she went to take the second shot next time, and all hell broke loose. The second shot was 11Jan2021, and that night it she noted her joints were starting all over again, and she had restless leg syndrome, cold chills and everything, so she went to bed, she didn't have Benadryl, so she got up, and that night took Tylenol, she didn't get very much sleep, and she was very annoyed the next day, she felt like the first time, that like she got it an accident, feeling terrible, that night, and she can lay on the couch to relax, but with the restless leg syndrome, and her joints all day long, she just went yesterday to buy Advil Arthritis, and she never had arthritis before or anything. Restless leg syndrome depends, sometimes it was better than other time. Joint pain was not improving, she was so aggravated about that, she was not feeling 100%, people look at her and say she doesn't look like she feels good, she doesn't, and she was ready to bite their heads off, she was very active, always in the gym or something, she has 3 kids in the military, and was always meeting up with them to do military runs and just this was ridiculous. Stated she took a picture of the vaccine card, as she sent it to a few people. This was definitely the Pfizer vaccine, she has told many people, many people know do not take this, she was so irritated, it's not even funny. The case was reported as non-serious. The outcome was not recovered for the events joint pain, restless leg syndrome and fatigue; and unknown for the rest of the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/22/2020,12/22/2020,0.0,UNK,VITAMIN C [ASCORBIC ACID]; OMEGA 3 [FISH OIL]; TURMERIC [CURCUMA LONGA],,Medical History/Concurrent Conditions: Menopause; Seasonal asthma (Diagnosed when she was a child); Thyroid disorder (she takes a thyroid medicine),,,"['Anger', 'Arthralgia', 'Body temperature', 'Body temperature decreased', 'Chills', 'Emotional disorder', 'Fatigue', 'Feeling abnormal', 'Illness', 'Influenza like illness', 'Nausea', 'Restless legs syndrome', 'Vomiting']",1,PFIZER\BIONTECH, 1074174,MD,35.0,F,"Pale; Sweaty; her left arm was extremely sore; elevated heart rate/heart rate was in the 120s, and she usually has a heart rate in the 80s; shortness of breath; approximately 22 hours after receiving her first COVID-19 Vaccine, her left arm started swelling slightly down from the COVID-19 Vaccine injection site; the COVID-19 Vaccine injection site became red, warm, and itchy; the COVID-19 Vaccine injection site became red, warm, and itchy; the COVID-19 Vaccine injection site became red, warm, and itchy; Blood pressure increased; Clammy/cold sweat; muscle tenderness/all the muscles in her left arm were tender/aching; bruising near the injection site; she had bruising (more than usual) throughout the rest of her body; she noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) the lymph nodes in her left axillary (or armpit area) were swollen, and super tender; she noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) the lymph nodes in her left axillary (or armpit area) were swollen, and super tender; anxiety; This is a spontaneous report from a contactable consumer (patient/Registered Medical Assistant). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL0142), via an unspecified route of administration on 12Jan2021 14:30 (2:30 PM) at single dose on left deltoid for COVID-19 immunization. Vaccination facility type is hospital. No history of previous immunization and no additional vaccines administered on same date of Pfizer suspect, also reported as ""Prior Vaccinations (within 4 weeks): None"". Medical history included ongoing Vitamin D deficiency for quite a few years. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) from Oct2020 and ongoing at 50000 IU gel cap, once weekly for Vitamin D deficiency. Patient is scheduled to receive the second dose of Pfizer vaccine on 02Feb2021 but reported side effects from her first shot including bruising near the injection site, shortness of breath, muscle tenderness and elevated heart rate (main concern). Upon contacting her HCP, she mentioned that this may be a side effect of her anxiety medications and asked ""Should she take the second dose?"". Approximately 22hours (13Jan2021) after receiving her first COVID-19 Vaccine, her left arm started swelling slightly down from the COVID-19 Vaccine injection site. COVID-19 vaccine injection site became red, warm, and itchy, also experienced blood pressure increased, shortness of breath and Clammy, all on 13Jan2021. The patient was pale on 13Dec2020. Patient noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) that the lymph nodes in her left axillary (or armpit area) were swollen, and super tender (onset reported as ""Jan2021""). Patient became sweaty on 14Jan2021. It was further reported that patient received her first COVID-19 Vaccine dose on 12Jan2021 2:30PM . She said after receiving the first COVID-19 Vaccine, she has had multiple symptoms. Patient is now due for her second COVID-19 Vaccine dose today 02Feb2021. Patient did not know if she should get the second COVID-19 Vaccine dose, and if her side effects were from the first COVID-19 Vaccine. Patient works in a doctor's office where there is a medical doctor, nurse practitioner, and several other registered medical assistants. Approximately 12 hours later after vaccine, at 2:30AM (13Jan2021), her left arm was extremely sore. She said she went to work on Wednesday, 13Jan2021, and her left arm was still really sore, but she was fine, otherwise. She said approximately 22 hours after receiving her first COVID-19 Vaccine, her left arm started swelling slightly down from the COVID- 19 Vaccine injection site. She said her COVID-19 Vaccine was given a lot higher than she thinks the vaccine should have been given. She said the COVID-19 Vaccine injection site became red, warm, and itchy. Her heart rate and blood pressure shot up, and she had pretty bad shortness of breath. Patient said that the medical doctor and nurse practitioner (where she works) told her she gave herself a panic attack. She said that the medical doctor, who she works for, told her to go home, and to contact her primary care doctor if she doesn't feel better. Patient left work and went home. Patient clarified her heart rate was in the 120s, and she usually has a heart rate in the 80s. She said she was pale and clammy, too. Patient stated that she went to bed when she got home from work on 13Jan2021, and woke up the next morning (Thursday, 14Jan2021), and got ready for work. She said as she was getting dressed for work, she felt her pulse rate go up, and she became sweaty, and clammy. She said she called her work, and her boss (medical doctor) told her to take some Tylenol and rest, and to call her primary care doctor if she was not feeling better. Patient said that her primary care doctor said she was having anxiety, and started her on medicine. She said the medicine helped, but her heart rate was still 112-115. She said she noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) the lymph nodes in her left axillary (or armpit area) were swollen, and super tender. She said all the muscles in her left arm were tender, as well. She said her left arm muscles were still aching. She said she had bruising on her left arm, and noticed she had bruising (more than usual) throughout the rest of her body. She said she has no idea if the bruising is a coincidence, or if the bruising is related to receiving the COVID-19 Vaccine. Patient mentioned that her left axillary lymph nodes were swollen for a good week and a half, but the swelling improved and was gone now. She said her heart rate was still elevated at 106-110 when she last checked her heart rate an hour and half ago. She said her heart rate was elevated, even though she was sitting down doing tele-work, and she has been taking anxiety medicine. She said she was still having breathing discomfort, clarifying she could not take a big enough breath. Patient will take a big breath, and will be good for a while, but then she needs to take another big breath. She said her doctor has checked her lungs, and her lungs were clear. She said she has to take multiple, deep breaths throughout the day. Patient's last blood work was in Oct2020. She said everything was good with her blood work. She said her hormones were good, but she had a Vitamin D deficiency. For treatment, patient stated that her primary care doctor prescribed Buspar 7.5mg, twice a day. She said the Buspar 7.5mg was dispensed in a pharmacy bottle and did not have the NCD, Lot, and Expiration Date. She said it will be 3 weeks from tomorrow (03Feb2021) she has been taking the Buspar 7.5mg and reported everyone seems to think she has anxiety, or she was crazy. Events did not require emergency room visit but patient visited physician office. There were no relevant tests. Outcome of muscles in her left arm were tender/aching, was not recovered, for axillary lymph nodes swelling and tender was recovered in 2021, for heart rate was elevated, Shortness of breath/breathing discomfort was recovering while for other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/01/2021,,PVT,VITAMIN D [COLECALCIFEROL],Vitamin D deficiency,,,,"['Anxiety', 'Blood pressure abnormal', 'Blood pressure increased', 'Blood test', 'Cold sweat', 'Contusion', 'Dyspnoea', 'Heart rate', 'Heart rate increased', 'Hyperhidrosis', 'Lymph node pain', 'Lymphadenopathy', 'Myalgia', 'Pain in extremity', 'Pallor', 'Peripheral swelling', 'Pulmonary function test', 'Vaccination site bruising', 'Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site warmth', 'Vitamin D']",1,PFIZER\BIONTECH, 1074175,,,F,"soreness; This is a spontaneous report from a non-contactable consumer. A 28-year-old female patient received first dose of bnt162b2 (BNT162B2 lot number and expiry date not reported) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced soreness on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148908 same patient/drug, different dose/event",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain'],1,PFIZER\BIONTECH, 1074176,,,F,"rash that itches; arm hurts; trouble hearing; itchiness; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 21Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash and itchiness on an unspecified date in 2021. The patient reported she had the Covid shot on 21Jan2021 and has a rash now and it itches. On 2021, her arm hurts, but otherwise she was fine. The patient was due for the other one on 11Feb2021 and she wanted to know if she can take it in the same arm. She mentioned trouble with hearing and also puts husband on line. The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,,,UNK,,,,,,"['Hypoacusis', 'Pain in extremity', 'Pruritus', 'Rash pruritic']",1,PFIZER\BIONTECH, 1074177,MN,80.0,M,"knocked out due to fatigue; legs were just worked up/area where he had arthritis (knees and wrist) were affected the most/knee joints were so bad/knee joints were so bad that he could barely walk/wrist joints were also bad; This is a spontaneous report from a contactable consumer (patient) reported that an 80-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283, expiry date unknown), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing arthritis which the patient had for 10 years or so and blood pressure. The patient has a positive COVID test on Sep2020. Concomitant medication included methotrexate (manufacturer unknown) for arthritis, losartan (manufacturer unknown) for blood pressure, hydroxychloroquine sulfate (PLAQUENIL) for arthritis and acetylsalicylic acid (CARTIA, reported as 'kartia') for blood pressure all ongoing and levothyroxine sodium (SYNTHROID) from an unspecified date to an unspecified date. The patient stated that he was okay the first day. Then the next day, it knocked the legs right from underneath him. His legs were just worked up and he knocked out due to fatigue. Mainly the area where he had arthritis (knees and wrist) were affected the most. He was in bed for a couple of days. At one point, his knee joints were so bad that he could barely walk. His wrist joints were also bad as he has arthritis in both knees and wrists. It lasted from the 28Jan2021 to the 30Jan2021. He has recovered from it. His knees are good, and his wrists are back to their normal aches and pains. During the time of the report he was feeling pretty good. He was concerned about the second shot and would like more information. He wanted to know if the second shot will cause more severe side effects. The outcome of the events was recovered on 30Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/28/2021,1.0,UNK,METHOTREXATE; LOSARTAN; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; CARTIA [ACETYLSALICYLIC ACID]; SYNTHROID,Arthritis,Medical History/Concurrent Conditions: Blood pressure abnormal,,,"['Arthropathy', 'Fatigue', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1074178,NJ,55.0,M,"pain in right arm redness swelling; pain in right arm redness swelling; pain in right arm redness swelling; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9261), via an unspecified route of administration in the right arm, on 22Jan2021 at 17:00 (at the age of 55-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included atorvastatin calcium (LIPITOR). The patient experienced pain in right arm redness swelling on 23Jan2021. The events were reported as non-serious. The patient did not receive any treatment for the events. The clinical outcome of pain in right arm redness swelling was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/23/2021,1.0,PHM,LIPITOR [ATORVASTATIN CALCIUM],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Erythema', 'Pain in extremity', 'Peripheral swelling']",1,PFIZER\BIONTECH, 1074179,IL,39.0,F,"Heavy headed; Sore; so tired that could only sleep; Felt unwell; Extreme tiredness/so tired that could only sleep; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL8982), via an unspecified route of administration in the left arm on 29Jan2021, at 14:15 as single dose for covid-19 immunization. Medical history included allergy to mangos from an unknown date. The patient felt unwell on 01Feb2021 with outcome of not recovered; extreme tiredness/so tired that could only sleep on 01Feb2021 with outcome of not recovered; heavy headed on 02Feb2021 with outcome of not recovered; sore on 02Feb2021 with outcome of not recovered. The events were reported as non-serious as no treatment was given for them. Prior to vaccination, no diagnosis of COVID-19 was noted, and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/01/2021,3.0,PVT,,,Medical History/Concurrent Conditions: Fruit allergy (Allergy to Mangos),,,"['Fatigue', 'Head discomfort', 'Malaise', 'Pain', 'Sleep disorder due to a general medical condition']",1,PFIZER\BIONTECH, 1074180,IL,45.0,F,"rash; Shingles; intense burning; intense dizziness; body aches; fever of 102.7; left ear pain; This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3249), via an unspecified route of administration in the left arm, on 25Jan2021 at 15:30 (at the age of 45-years-old) at a single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFib), tachycardia, and allergy to proton pump inhibitors. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included metoprolol tartrate (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231) on 04Jan2021 at 11:00 (at the age of 45-years-old) in the left arm for COVID-19 immunization. The patient experienced body aches and fever of 102.7 on 26Jan2021, left ear pain in Jan2021, intense burning and intense dizziness on 01Feb2021, and rash and shingles on 02Feb2021. The events were reported as non-serious. The clinical course was reported as follows: The day after the vaccination, 26Jan2021, the patient had body aches intermittently (reported as: not bad) and then spiked a fever of 102.7 the evening of 26Jan2021. The pain (per family recollection: complains of left ear pain) started about 28Jan2021 or 29Jan2021, but intense burning, pain, and intense dizziness started on 01Feb2021 with diagnosis of rash and shingles on 02Feb2021. Therapeutic measures were taken as a result of all of the events, which included valacyclovir (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN). The clinical outcome of body aches, fever, left ear pain, intense burning, intense dizziness, rash, and shingles was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/01/2021,,SEN,METOPROLOL TARTRATE,,Medical History/Concurrent Conditions: AFib; Allergic reaction to drug; Tachycardia,,,"['Body temperature', 'Burning sensation', 'Dizziness', 'Ear pain', 'Herpes zoster', 'Pain', 'Pyrexia', 'Rash']",2,PFIZER\BIONTECH, 1074181,AR,72.0,F,"Headache; tired; This is a spontaneous report from a contactable consumer. A non-pregnant 72-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:EL9261), via an unspecified route of administration in the left arm on 01Feb2021 at 14:00 at 72-years-old at a single dose for covid-19 immunization; administered in a hospital. . The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's medical history was reported as none. Concomitant medications included elderberry [sambucus nigra] (MANUFACTURER UNKNOWN), krill oil (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D); all taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of vaccination. On 02Feb2021 (also reported as 01Feb2021 at 16:00), the patient experienced headache (non-serious) and tired (non-serious). There was no treatment received for the adverse events. The clinical outcome of the events was recovered on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/02/2021,1.0,PVT,ELDERBERRY [SAMBUCUS NIGRA]; KRILL OIL; ZINC; VITAMIN D [COLECALCIFEROL],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE,,,"['Fatigue', 'Headache']",1,PFIZER\BIONTECH, 1074182,MI,,M,"arm soreness; This is a spontaneous report from a non-contactable consumer (patient wife). An elderly male patient of unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunisation. The patient medical history included covid prior vaccination. The patient concomitant medication was not reported. The patient experienced arm soreness on an unknown date in Jan2021. The outcome of the event arm soreness was unknown No follow-up attempts are possible. Information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1074183,FL,52.0,F,"she was very annoyed the next day; felt like the first time that like she got it an accident; feeling terrible; Restless leg syndrome/same thing before, but this hurts a lot worse, and it not going away; Restless leg syndrome/same thing before, but this hurts a lot worse, and it not going away; Fatigue; Her joints are hurting her/Fatigue/same thing before, but this hurts a lot worse, and it not going away; Cold chills; didn't get very much sleep; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE/PFIZER COVID SHOT; lot number: EL1284; expiration date: unknown) at vaccination age of 52-year-old via an unspecified route of administration in the left arm on 11Jan2021 at a single dose for prevention, she works in a hospital (covid-19 immunization). Medical history included seasonal asthma, cross fit (exercise adequate), and paleo and keto eating, thyroid is giving her problem, menopause. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE/PFIZER COVID SHOT; lot number: EH9899) at vaccination age of 52-year-old via an unspecified route of administration on 22Dec2020 at a single dose for prevention, she works in a hospital (covid-19 immunization) but got sick and was nauseous, flu like symptoms, restless leg syndrome, fatigue, joints are hurting her, she doesn't feel like doing crap and is miserable everyday, threw up, felt like she was in a car accident, that is how bad she felt, cold chills and anger. Concomitant medications included fish oil (OMEGA 3), ascorbic acid (VITAMIN C), Apple Cider Vinegar, thyroid medicine and vitamins. She reported that she took the second shot 11Jan2021 (to this day), she still has restless leg syndrome, fatigue, and her joints are hurting her. She had the same thing before, but this hurts a lot worse, and it not going away. She is taking Turmeric, everything, and everyone says to just keep taking Tylenol or Advil but she can't keep taking it because now it was upsetting her stomach, or like arthritis medicine, she is taking Omega 3 and vitamins. She added that she went to take the second shot next time, and all hell broke loose. That night (11Jan2021), she noted her joints were starting all over again, and she had restless leg syndrome, cold chills and everything, so she went to bed. she didn't have Benadryl, so she got up, and that night took Tylenol, she didn't get very much sleep, and she was very annoyed the next day (12Jan2021). She felt like the first time that like she got it an accident, feeling terrible that night, and she can lay on the couch to relax but with the restless leg syndrome, and her joints all day long. She just went yesterday to buy Advil Arthritis, and she never had arthritis before or anything. She mentioned that the restless leg syndrome outcome depends, sometimes it is better than other time, as for the joint pain, it was not improving, she is so aggravated about that, she is not feeling 100%, people look at her and say she doesn't look like she feels good (she doesn't) and she is ready to bite their heads off since she is very active, always in the gym or something. She started Turmeric since she is desperate, this has been going on since 11Jan2021, anything she is doing now is not doing anything. She does not know what to do as every doctor will say maybe she should see this doctor, but she didn't feel like this before this shot. She was tired of feeling this way, she didn't feel this way before the shot, and if anyone met her, they know it. The outcome of the event restless leg syndrome was recovering, arthralgia was not recovered while the outcome of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/11/2021,0.0,UNK,OMEGA 3 [FISH OIL]; VITAMIN C [ASCORBIC ACID],,Medical History/Concurrent Conditions: Exercise adequate; Ketogenic diet; Menopause; Seasonal asthma; Thyroid disorder,,,"['Arthralgia', 'Chills', 'Condition aggravated', 'Fatigue', 'Feeling abnormal', 'Insomnia', 'Irritability', 'Malaise', 'Restless legs syndrome']",2,PFIZER\BIONTECH, 1074184,VA,74.0,F,"Almost threw up last night; joint pain; Few little odd pains; soft pain that make her feel weak and then go away; Nauseous; No dizziness, but unsteadiness; Tired; Headaches; began to feel a little bad/ generally didn't feel well/Malaise; Feels like the stomach flu; Weak; Gentle muscle ache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via an unspecified route of administration on 28Jan2021 15:30 in left arm at single dose as Covid vaccine, etanercept (ENBREL, 50 mL/mg, Solution for injection in pre-filled pen, lot number: 1119808, expiry date: Apr2023) via an unspecified route of administration from an unspecified date and ongoing at 1 DF weekly to the stomach area for rheumatoid arthritis, methylprednisolone (MEDROL, tablet) oral from an unspecified date and ongoing at 3 mg, daily (1.5 tablets daily for total of 3 mg) for rheumatoid arthritis, methotrexate (tablets) oral from an unspecified date and ongoing at 20 mg, weekly (2.5 mg tablets, 20 mg total) for rheumatoid arthritis. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic or chromosomal abnormalities, endocrine abnormalities (including diabetes and obesity) and took levothyroxine, rheumatoid arthritis. She had had regular blood work for rheumatoid arthritis and that was normal for her, they were relatively normal and her ESR was down. No additional vaccines administered on same date of BNT162B2. No other vaccines given the same day or 4 weeks prior. The patient's concomitant medications included levothyroxine daily for endocrine abnormalities. It was a daily thing for the body and the body couldn't live without it if it did not have it. The patient previously took the Shingrix vaccine and it was terrible for her and put her into a rheumatoid arthritis flare and was taking prednisone and was getting better and the wap she was in a rheumatoid flare. No prior vaccinations received within 4 weeks prior to the first administration date of the suspect vaccine. The patient was taking 3 medicines for rheumatoid arthritis that might or might not affect the RNA in the vaccine. She wondered if etanercept would have an effect on the vaccine since it was shipped on ice overnight. She did not think they would affect anything. Nobody has said anything about the medications and she just wanted to get the vaccine. Her doctor knows nothing about the interactions and none of them seem to know if it is normal to have these symptoms 4 days after getting the vaccine. She felt great the first 2 days after getting the vaccine and then began to feel a little bad. She was having some symptoms maybe 4 days on 01Feb2021 after receiving the Covid vaccine and wanted to know if that was sort of normal. It was unusual for her, but she had nauseous, not dizziness, but unsteadiness, tired, also headaches and generally didn't feel well. She felt like she might have the stomach flu, but had not had that in so many years. She also felt weak. No temperature. Gentle muscle ache. On 01Feb2021 Monday night she had the nausea. On 02Feb2021 Tuesday, she had it again, and had it again today and almost threw up last night. Just the malaise or tiredness had gotten worse. She could not tell the difference between the rheumatoid arthritis, joint pain and muscle pain and this with the vaccine. She was having a few little odd pains, but nothing that she hadn't had before. It was more of a soft pain, they made her feel weak and then they went away. It was more muscle than joint. The events did not require a visit to emergency room or physician office. She was supposed to get a second dose but felt she shouldn't, it might put her back into a rheumatoid flare. She was just getting over it and afraid to go through that with the Covid vaccine also. The action taken in response to the events for etanercept, methylprednisolone and methotrexate was dose not changed. The outcome of events nausea, unsteadiness, tired (tired was reported as worsened), generally does not feel well, feels like the stomach flu, weak, few little odd pains; soft pain, joint pain was not recovered, of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/01/2021,4.0,PVT,LEVOTHYROXINE; Medrol; METHOTREXATE; Enbrel,,"Medical History/Concurrent Conditions: Allergy; Chromosome abnormality; Endocrine disorder (including diabetes and obesity, and took levothyroxine); Gene mutation; Immune system disorder; Respiratory disorder; Rheumatoid arthritis",,,"['Arthralgia', 'Asthenia', 'Balance disorder', 'Blood test', 'Fatigue', 'Gastroenteritis viral', 'Headache', 'Malaise', 'Myalgia', 'Nausea', 'Pain', 'Red blood cell sedimentation rate', 'Vomiting']",1,PFIZER\BIONTECH, 1074185,NY,49.0,M,"Bitter metallic taste in my mouth; fatigue; arm soreness; lip tingling; headache; This is a spontaneous report from a contactable consumer (patient). This 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9262) via an unspecified route of administration in the left arm on 02Feb2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history included kidney cancer from 2009 and unknown if ongoing; costochondritis from an unknown date and unknown if ongoing; non-alcoholic fatty liver disease (NAFLD) from an unknown date and unknown if ongoing; gastroesophageal reflux disease (GERD) from an unknown date and unknown if ongoing; irritable bowel syndrome (GERD) from an unknown date and unknown if ongoing; migraines from an unknown date and unknown if ongoing, low immunoglobulin A (IgA) from an unknown date and unknown if ongoing; and steri strip allergy from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included rosuvastatin calcium (CRESTOR) from an unknown date for an unknown indication; vitamin D from an unknown date for an unknown indication; and vitamin B12 from an unknown date for an unknown indication. The patient previously received a dose of BNT162B2 (lot number EK5730) in the left arm on 12Jan2021 for COVID-19 immunization. On an unspecified date in 2021 (reported as 02Jan2021 at 15:00) the patient experienced bitter metallic taste in his mouth, fatigue, arm soreness, lip tingling and headache. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. Lab tests and procedures included polymerase chain reaction via nasal swab on 31Jan2021 with negative results. The clinical outcomes of bitter metallic taste in his mouth, fatigue, arm soreness, lip tingling and headache were not recovered. It was also reported that since vaccination the patient was tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,,,PVT,CRESTOR; VITAMIN D NOS; VITAMIN B12 [VITAMIN B12 NOS],,Medical History/Concurrent Conditions: Adhesive tape allergy; Costochondritis; GERD; Immunoglobulin A low; Irritable bowel syndrome; Kidney cancer; Migraine; Nonalcoholic fatty liver disease,,,"['Dysgeusia', 'Fatigue', 'Headache', 'Pain in extremity', 'Paraesthesia oral', 'Polymerase chain reaction']",UNK,PFIZER\BIONTECH, 1074186,NC,,F,"Four small raspberry type ""burn"" left arm; Small taste in mouth; This is a spontaneous report from a contactable consumer (patient herself). A 79-year-old female patient (non-pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on unspecified date at single dose for COVID-19 immunization at Hospital. Medical history included embolism in 2012 and pacemaker in 2019. No other vaccines received by patient within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took lidocaine and ciproflaxin and experienced allergies to both. After patient had First shot on unspecified date also had four small raspberry type ""burn"" left arm and small taste in mouth they advised to take Tylenol. Since the vaccination, patient has not been tested for COVID-19. The outcome of events was unknown. Information about batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021091714 Same reporter/patient/drug, different events",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PVT,,,Medical History/Concurrent Conditions: Embolism; Pacemaker insertion (cardiac),,,"['Dysgeusia', 'Thermal burn']",1,PFIZER\BIONTECH, 1074187,,63.0,U,"Chills, aches, minor headache, minor nausea, and fatigue; Chills, aches, minor headache, minor nausea, and fatigue; Chills, aches, minor headache, minor nausea, and fatigue; Chills, aches, minor headache, minor nausea, and fatigue; Chills, aches, minor headache, minor nausea, and fatigue; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative. A 63-years-old patient of an unspecified gender received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot # EL8982, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took warfarin for cerebrovascular accident, anastrazol vegal for neoplasm malignant. On an unspecified date the patient experienced chills, aches, minor headache, minor nausea, and fatigue. At the time of the report the event outcome was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain']",1,PFIZER\BIONTECH, 1074188,,,F,"they have sore arms; This is spontaneous report from Pfizer Sponsored program. A non-contactable female consumer of an unspecified age reported for herself that received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 01Feb2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced sore arms on an unspecified date. The outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,,,UNK,,,,,,['Pain in extremity'],UNK,PFIZER\BIONTECH, 1074189,TN,84.0,F,"she felt her blood pressure was up and so she checked, it was at 179; her sugar was down; Dizziness; Weakness; Nausea/felt sick to her stomach; Diarrhea; Headache; Tiredness; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER VACCINE SHOT; lot number: EL3248; expiration date: unknown) at vaccination age of 84-year-old via an unspecified route of administration in the left arm on 29Jan2021 09:20 at a single dose for covid-19 immunization. Medical history included open heart surgery, diabetic/diabetes, high blood pressure, bone and joint problems, and her bones were already hurting for a long time before. She was calling because she was asked if she was allergic to anything, she is allergic to one medication, but she thinks they need to know more about her health conditions before giving this medication. Familial history included all of her family that has passed, died of diabetes or cancer. Concomitant medications included unspecified other blood pressure medication and nifedipine for blood pressure. The patient did not receive other vaccination within 4 weeks. The patient reported that she took the shot on 29Jan2021 and she stayed for the 15 minutes, but she didn't have any feeling about it. A little more than an hour later (29Jan2021), she had a slight headache, then she got tired and felt like she needed to lay down. She did lay down and slept 9 hours. The patient reported that she felt her blood pressure was up and so she checked, it was at 179 [unspecified unit]. It was at that point she called her children and told them she was not doing well. She does feel this is under control at this point. The next morning (30Jan2021), she had dizziness, weakness, felt sick to her stomach, and had a slight headache. She clarified that the sick to her stomach feeling was nausea and diarrhea both started on 30Jan2021. It had resolved as of 31Jan2021. She mentioned that she feels better but the tiredness is still going on today. It is explained that her blood pressure was up and her sugar was down on 30Jan2021, she is a diabetic. She takes blood pressure medication, but it wasn't bringing it down at first. She explained that when she took her blood sugar it was 70 [unspecified unit] something on 30Jan2021. Her normal is 120-121 [unspecified unit] (unspecified date) and that is where she likes to keep it so that was a problem. She has had to eat sweets to get it up, but it won't stay up. She reported that the tiredness, dizziness, and headache are still going on right now. She was calling because she was asked if she was allergic to anything, she is allergic to one medication, but she thinks they need to know more about her health conditions before giving this medication. She feels they should ask more questions or have the doctor send a recommendation over or information about a person. The outcome of the events headache was not recovered, as for the events dizziness and tiredness were recovering while the outcome of the events nausea and diarrhea were recovered on 31Jan2021. The outcome of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,UNK,NIFEDIPINE,,Medical History/Concurrent Conditions: Blood pressure high; Bone disorder; Bone pain (for a long time before); Diabetes; Drug allergy; Family history of cancer (all of her family that has passed); Family history of diabetes (all of her family that has passed); Joint disorder; Open heart surgery,,,"['Asthenia', 'Blood glucose', 'Blood glucose decreased', 'Blood pressure increased', 'Blood pressure measurement', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Nausea']",UNK,PFIZER\BIONTECH, 1074190,,,F,"chronic pain in right side of her body/sharp pain; she was experiencing a sharp pain or sensation of burning; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported for similar events. This is the first of the two reports. A female patient of an unspecified age received the second dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 26Jan2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She had her first dose of vaccine on 22Dec2020 and she was fine with just a little sore arm. On 29Jan2021, she was in the ER for chronic pain in right side of her body and also was experiencing a sharp pain or sensation of burning. The outcome of events was unknown. The information on the lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021149308 same reporter/drug/event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/29/2021,3.0,UNK,,,,,,"['Burning sensation', 'Pain']",2,PFIZER\BIONTECH, 1074191,TX,82.0,F,"ache on her left arm; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. An 82-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date: 31May2021), via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunisation. Medical history included breast cancer from 01Dec2020 to an unknown date. Concomitant medication included simvastatin and lisinopril. It was reported that she got her first dose on 23Jan2021 and she got an ache on her left arm and then she was originally scheduled for second dose on 13Feb2021, however though, she was rescheduled to have the second dose on 9Feb2021, that is 17 days earlier and she is worried about it and matter of fact is she will have an surgery of breast lumpectomy on 11Feb2021. So, her concern is if she can second dose early and or if it's okay to have the surgery prior the vaccination. The patient underwent lab tests and procedures which included weight: about 200 pounds (overweight) on an unspecified date. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,,,UNK,SIMVASTATIN; LISINOPRIL,,Medical History/Concurrent Conditions: Breast cancer,,,"['Pain in extremity', 'Weight']",1,PFIZER\BIONTECH, 1074192,AZ,,M,"Dizzy; This is a spontaneous report from a contactable lawyer. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 02Feb2021 14:00 at single dose for COVID-19 immunisation. Medical history included ongoing blood pressure high. Concomitant medication included carvedilol for blood pressure high. The patient got first vaccine on Tuesday at 2 PM in the afternoon and last evening, 38 hours later (04Feb2021) at 4 in the morning he got up and almost feel that he was dizzy and he was still dizzy, just a little bit less than maybe before. No treatment received for adverse event. Outcome of event was not recovered. Information about batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/04/2021,2.0,UNK,CARVEDILOL,Blood pressure high,,,,['Dizziness'],UNK,PFIZER\BIONTECH, 1074230,AK,33.0,F,"Anaphylaxis happened within 12 minutes. I was administered epinephrine at the vaccine site, as well as in the ambulance. FURTHERMORE I was administered DiphenhydrAMINE, Famotidine, solu-MEDROL at the Emergency Department. Those are just a few of what I received. When I was finally discharged I was sent home with 2 epi-pens and a 4 day dosing of Prednisone.",Not Reported,,Yes,Not Reported,,Not Reported,U,03/04/2021,03/04/2021,0.0,PHM,"Hair, Skin, & Nails Daily Vitamins",NONE,Degenerative Disc Disease,,Minocycline,"['Anaphylactic reaction', 'Full blood count', 'Metabolic function test']",1,MODERNA,IM 1074247,VA,2.0,F,Death,Yes,03/03/2021,Not Reported,Yes,17.0,Not Reported,N,02/25/2021,03/01/2021,4.0,PVT,,,,,,['Death'],2,PFIZER\BIONTECH,IM 1074260,CA,67.0,M,"I had whole body aches, extreme fatigue, chills, fever, tachycardia (well over 100 beats per minute), unable to hold any item in my hands without it moving to and fro about 8 inches, some headaches, unsteady gait when ambulating. Almost felt like falling. I didn't want to move in bed since it would only exacerbate the body aches and make it worse. Horrible time 1st dose 02/03/2021 Negligible side effects (only sore injection site) Date of 2nd dose 03032021",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/03/2021,03/03/2021,0.0,OTH,No medications being taken whatsoever,No other illnesses and no vaccinations up to one month prior except the 1st Moderna injection,None,,Only allergy is Sulfa Drugs No food allergy or other products,"['Chills', 'Fatigue', 'Gait disturbance', 'Headache', 'Injection site pain', 'Motor dysfunction', 'Pain', 'Pyrexia', 'Tachycardia']",2,MODERNA,IM 1074271,CA,74.0,F,"altered mental status, acute on chronic thrombocytopenia, death",Yes,03/03/2021,Not Reported,Yes,1.0,Not Reported,N,02/28/2021,03/02/2021,2.0,PVT,"furosemide, lactulose, zofran, compazine, spironolactone, tenofovir, advil, on chemotherapy","metastatic Cholangiocarcinoma, cirrhosis",as above,,"sulfa, cotrimazole","['Death', 'Mental status changes', 'Thrombocytopenia']",UNK,MODERNA,IM 1074283,NY,60.0,M,"PATIENT RECEIVED THE VACCINE, AND WILL SITTING IN THE RECOVERY ROOM, FELT HOT, DIZZY AND SWEATY AS WELL AS OBTUNDED. BP 90/42, HR 55 SAT 97 RR12 DIAPHORETIC, AROUSABLE, COHERENT CV PULSE DIFFICULT TO PALPATE, BRADYCARDIC PHYSICAL EXAM OTHERWISE UNREMARKABLE PLACED ON STRETCHER. MENTAL STATUS IMPROVED. VS 115/97, 75, 12, SAT 98 TRASNFERRED TO EMERGENCY ROOM FOR EVALUATION",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,NONE,NONE,NONE,,NONE,"['Bradycardia', 'Feeling hot', 'Hyperhidrosis', 'Lethargy', 'Palpatory finding abnormal']",1,JANSSEN,IM 1074300,IL,,U,"Patient received vaccine exposed to a temperature of 32�F degrees for 7 and a half hours; A spontaneous report was received from a nurse concerning patients of unknown ages and genders who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history and concomitant medication use was not reported . On 23-Jan-2021, the patients received their planned dose of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. Late Friday evening, 22-Jan-2021, approximately one day prior to the onset of event, the vaccine administrator removed vials from the freezer and put them in a refrigerator for usage during the vaccination event that was set to occur on Saturday, 23-Jan-2021. In the refrigerator, the vaccines were stored for seven and a half hours at 32�F. It was reported that the vials were cold on Saturday and were used during the vaccination event. They had record of all the patients who received this vaccines, but reporter did not consider this a temperature excursion because their information stated that ""vials can be stored refrigerated between 2� to 8�C (36� to 46�F)"" and reach a temperature of 36�F. Treatment is not applicable Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event is not applicable; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, unknown lot number, with no associated AEs. Causality for the event is not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/23/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No Reported medical history.),,,['Product storage error'],UNK,MODERNA,OT 1074301,OH,80.0,F,"Passed out; Felt tired; A spontaneous case report was received from a consumer concerning an 80 years-old female patient who experienced passed out (MedDRA PT: loss of consciousness) and felt tired (MedDRA PT: fatigue) The patient's medical history included cancer. Concomitant product use included chemotherapy and other medications (not specified). The patient received their first of two planned doses of mRNA-1273 (Lot # not provided) on an unknown date. On 16 Feb 2021, approximately one day prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot #011M20A) intramuscularly in an unspecified site for prophylaxis of COVID-19 infection. On 17 Feb 2021, one day after receiving the vaccination, the patient felt tired and passed out. The patient inquired if this was a normal side effect. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events passed out and felt tired is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/16/2021,02/17/2021,1.0,UNK,,Cancer (Undergone chemo and taken medications.),,,,"['Fatigue', 'Loss of consciousness']",1,MODERNA,OT 1074302,OH,67.0,F,"heart raced 130 bpm; right arm went numb; bitter medicine taste; lips and tongue tingling; numbness of the lips; numbness of the throat; dry mouth; super thirsty; elevated blood pressure of 175/56; couldn't talk; shaking; terrible pain in chest and mid area; gassiness; headache; Nausea; A spontaneous report was received from a Consumer concerning a 67 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like bitter medicine taste in her mouth, lips and tongue tingling, numbness of the lips and throats, dry mouth, super thirsty, heart raced 130bpm, elevated blood pressure of 175/56, couldn't talk, shaking, terrible pain in chest and mid area, nausea, right arm went numb, gassiness, and headache. The patient's medical history provided included Lupus and Sjogren's. No relevant concomitant medications were reported. On 12-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Feb 2021, The patient experienced the events of bitter medicine taste in her mouth, lips and tongue tingling, numbness of the lips and throats, dry mouth, super thirsty, heart raced 130bpm, elevated blood pressure of 175/56, couldn't talk, shaking, terrible pain in chest and mid area, nausea, right arm went numb, gassiness, and headache. Laboratory details were not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events of bitter medicine taste in her mouth, lips and tongue tingling, numbness of the lips and throats, dry mouth, super thirsty, heart raced 130bpm, elevated blood pressure of 175/56, couldn't talk, shaking, nausea, right arm went numb, resolved on 12 Feb 2021. The outcome of the event headaches was resolved on 13 Feb 2021. At the time of the report the events of chest pain and gassiness were ongoing.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient's medical history of Lupus and Sjogren's can be contributing factor. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,UNK,,Lupus syndrome; Sjogren's syndrome,,,,"['Aphasia', 'Blood pressure increased', 'Chest pain', 'Dry mouth', 'Dysgeusia', 'Flatulence', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Nausea', 'Paraesthesia oral', 'Pharyngeal hypoaesthesia', 'Tachycardia', 'Thirst', 'Tremor']",1,MODERNA,OT 1074303,VA,,F,"Patient received less than the recommended dose; A spontaneous report, was received from a nurse, a female patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not reported. Concomitant medications were not reported. On an unknown date in Jan 2021, one day prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown), intramuscularly for the prophylaxis of COVID-19 infection. The nurse stated that they administered a vaccine and the patient received less than the recommended dose on an unknown date in Jan 2021. The nurse doesn't have any further information regarding the patient at this moment. Treatment is not applicable Action taken with second dose of mRNA-1273 in response to the event was not reported. The outcome of the event is not applicable; Reporter's Comments: This report refers to a case of vaccine underdose for mRNA-1273, unknown lot number with no associated AEs. Causality for this medication error is not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Incorrect dose administered'],1,MODERNA,OT 1074304,ND,,U,"PE; DVT; A spontaneous report was received from a pharmacist concerning patient (age and gender unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a pulmonary embolism (PE) and deep vein thrombosis (DVT). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced a PE and DVT. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events, PE and DVT, were not reported.; Reporter's Comments: Very limited information regarding the reported evens have been provided at this time. No additional information is expected as consent to follow up was denied.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Deep vein thrombosis', 'Pulmonary embolism']",1,MODERNA,OT 1074305,NV,16.0,F,"Vaccine was administered to a 16 year old; A spontaneous report was received from a pharmacist concerning a 16 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) (PT: Product administered to patient of inappropriate age) with no associated adverse events. The patient's medical history was not provided. No concomitant medications was reported. On 17-Feb-2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 016M20A) via unknown route for prophylaxis of COVID-19 infection. Treatment information was not applicable. Action taken with mRNA-1273 was not provided.. The outcome of the event, vaccine was administered to a 16 year old, was recovered/resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age 16 year old for mRNA-1273 (Lot number: 016M20A) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/17/2021,02/17/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA, 1074306,CA,66.0,F,"Doses administered less than one month apart; A spontaneous report was received from a consumer concerning a 66-year-old female patient who received two doses of Moderna's COVID-19 vaccine (mRNA-1273) less than one month apart. The patient's medical history was not provided. No concomitant medications were provided. The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 20 Jan 2021. On 10 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) in the for prophylaxis of COVID-19 infection. On 10 Feb 2021, second dose administered less than one month apart from first dose. On 19 Feb 2021, the patient donated blood one week after receiving both doses of the vaccine. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event doses administered less than one month apart was considered recovered.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, batch # unknown, with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/20/2021,02/10/2021,21.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Inappropriate schedule of product administration'],2,MODERNA,OT 1074307,,,F,"Felt some of the dose going down arm; Felt some of the dose going down arm; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient moved during the vaccination consequently some of the dose went down her arm. The patient's medical history was not provided. No concomitant product use was reported. On 19 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 16M20A) intramuscularly for prophylaxis of COVID-19 infection. It was reported that the patient moved during the vaccination consequently some of the dose went down her arm. Treatment information was not applicable. Action taken with mRNA-1273 was not applicable. The outcome of the event felt some of the dose going down arm, was considered as recovered on 19 Feb 2021. .; Reporter's Comments: This report refers to a case of Vaccine underdose AND Syringe Connection Issue for mRNA-1273, lot # 16M20A with no associated AEs. Causality for the medication error is not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Device connection issue', 'Underdose']",2,MODERNA,OT 1074308,,,U,"First dose to a patient who is under 18 years of age by a couple months; A spontaneous report was received from a pharmacist concerning a patient under 18-year-old, who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown), unknown route for prophylaxis of COVID-19 infection. On an unknown date, the patient who is under 18 years of age by a couple months received Moderna's COVID-19 vaccine (mRNA-1273). No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, patient who is under 18 years of age by a couple months received Moderna's COVID-19 vaccine (mRNA-1273) was considered resolved.; Reporter's Comments: This report refers to a case of Inappropriate age at vaccine administration for mRNA-1273, batch number - unknown, with associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1074309,NY,,F,"received the vaccine too high on her shoulder; Experienced a lot of pain; A spontaneous report ( was received from a physician concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced received the vaccine too high on her shoulder (incorrect route of product administration) and a lot of pain. The patient's medical history was not provided by the reporter. Concomitant medications were not reported. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. It was reported that the patient, who was a healthcare worker, received her vaccination too high on her shoulder. Additionally, she experienced a lot of pain. Treatment for the events was not reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, received the vaccine too high on her shoulder, was considered recovered/resolved. The outcome of the event, a lot of pain, was considered unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious unexpected event of Incorrect route of product administration for mRNA-1273 (lot # unknown) with associated unexpected adverse event of pain. Adverse event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Incorrect route of product administration', 'Pain']",1,MODERNA,OT 1074310,CA,35.0,U,"Second dose earlier than the recommended dosing window; A spontaneous report was received from a registered nurse for a 35-year old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and receieved the second dose earlier than the recommended dosing window. The patient's medical history was not provided. No concomitant product use was reported. On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection. On 03 Feb 2021, approximately 19 days apart, patient received second of the two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly for prophylaxis of COVID-19 infection. The patient received second dose a little early. No AEs were reported and no treatment medications were reported. The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event is not applicable. The outcome of the event, received dose earlier than recommended dosing window, was considered recovered/resolved on 03 Feb 2021.; Reporter's Comments: This report refers to a case of Inappropriate schedule of vaccine administered for mRNA-1273, lot # 013M20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,02/03/2021,19.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Inappropriate schedule of product administration'],1,MODERNA,OT 1074356,GA,48.0,F,I had epileptic seizures 6 days later and they haven't stopped. Never had seizures in my life,Not Reported,,Yes,Yes,2.0,Not Reported,N,01/15/2021,01/22/2021,7.0,OTH,None,None,None,,Sulfa Morphine,"['Computerised tomogram', 'Epilepsy', 'Magnetic resonance imaging']",,MODERNA,IM 1074361,PR,93.0,F,"General malaise, acetaminophen was given every 6 to 8 hours",Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,02/25/2021,02/26/2021,1.0,SEN,"Zyrtec HCllOmg. Namenda 10mg, Citalopram 20mg. Temazepan 15m",None,"HBP, dementia, COPD",,None,['Malaise'],1,MODERNA,IM 1074384,,,F,"Vial was shaken before administering; A spontaneous report was received from a health care professional who was also a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the vial was shaken before administered / wrong technique in product usage process. The patient's medical history was not provided. No relevant concomitant medications were reported. On date unknown, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273, lot # unknown, intramuscularly in for prophylaxis of COVID-19 infection. On 19 Feb 2021, the patient reported that the vial was shaken before it was administered to her. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported The event, vial was shaken before administered, was resolved on unknown date.; Reporter's Comments: This report refers to a case of Wrong technique in product usage process for mRNA-1273, lot # unknown with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Wrong technique in product usage process'],1,MODERNA,OT 1074385,NJ,,F,"Medical facility that gave a 16 year old the vaccine; A spontaneous report was received from a consumer concerning a female patient who received Modern's COVID-19 vaccine (mRNA-1273) at 16-year-old. The patient's medical history was unknown. Concomitant medication were not reported. On 14-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273, intramuscularly, at left deltoid (lot/batch: unknown) for prophylaxis of COVID-19 infection. No treatment information was provided. Action taken with mRNA-1273 in response to the event ""Inappropriate age at vaccine administration"" was not reported. The outcome of the event ""Inappropriate age at vaccine administration"" was resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1074386,KY,,F,"Vaccine administered subcutaneously instead of intramuscularly; A spontaneous report was received from a nurse concerning a 68 year-old, female who received Moderna's COVID-19 Vaccine (mRNA-1273) and the vaccine was administered subcutaneously instead of intramuscularly. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03-Feb-2021, the patient received their first of two planned doses of mRNA-1273 subcutaneously for prophylaxis of COVID-19 infection. On 03-Feb-2021, the patient's daughter, who was also a nurse, reported that the patient received her vaccine subcutaneously instead of intramuscularly. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine was administered subcutaneously instead of intramuscularly, was resolved on 03-Feb-2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.`",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Incorrect route of product administration'],1,MODERNA,OT 1074387,SD,17.0,M,"Pediatric patient received the first dose of the Moderna COVID19 vaccine; A spontaneous report, was received from a nurse, concerning a 17 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), which resulted in pediatric patient received the first dose of the Moderna COVID19 vaccine (product administered to patient of inappropriate age). The patient's medical history was not provided. No relevant concomitant medications were reported. On 19 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), for the prophylaxis of COVID-19 infection. The nurse who was the supervisor for outpatient monitoring reports an adverse event that a pediatric patient received the first dose of the Moderna COVID19 vaccine on 19 Feb 2021. The patient was a 17 years and 2 months old and declines to be contacted further for any further information. No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, pediatric patient received the first dose of the Moderna COVID19 vaccine, was recovered on 19 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1074388,,,F,"needle tip dislodged; some of the medication ran down the patient's arm, unknown how much of the dose the patient received; A spontaneous report was received from a nurse for a 60 year old white female patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No concomitant product use was reported. On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. While the vaccine was being administered the needle tip dislodged and consequentlysome of the medication ran down the patient's arm. The exact dose received by the patient was not reported. Treatment information was not applicable. Action taken with mRNA-1273 was not applicable. The outcome of the events needle tip dislodged and some of the medication ran down the patient's arm, unknown how much of the dose the patient received, was considered as recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No adverse event, Continue: [UNK], Comment: No reported medical history",,,"['Device connection issue', 'Underdose']",1,MODERNA,OT 1074389,KY,,U,"Adminstered second dose of vaccine on day 20; A spontaneous report were received from a healthcare professional, concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and administered second dose of vaccine on day 20. The patient's medical history was not provided. No relevant concomitant medications were reported. On 29 Jan 2021, nurse administered first dose of vaccine to the patient and on 17 Feb 2021 the second dose was administered. Nurse administered second vaccine to patient on day 20 after 1st Moderna vaccination (Inappropriate schedule of vaccine administered). Action taken in response to the Inappropriate schedule of vaccine administered was unknown. The outcome of the event Inappropriate schedule of vaccine administered was unknown.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Inappropriate schedule of vaccine administered without any associated adverse events.; Sender's Comments: 03 Mar 2021: Off label use check box was tick, (as per decription provided in the event section of source document).",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,02/17/2021,19.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Inappropriate schedule of product administration'],2,MODERNA,OT 1074390,NE,,M,"Under 18 year old patient vaccinated; A spontaneous report was received from other health care professional and concerns a 17-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273), characterizing, Under 18 year old patient vaccinated (PT: Product administered to patient of inappropriate age). The patient's medical history was not provided. The patient was allergic to penicillin. On 15-FEB-2021, an under 18-year-old patient, received their first of two planned doses of mRNA-1273 (batch number: 031L20A) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection, characterizing Product administered to patient of inappropriate age. The reporter wanted to know, if the patient could receive his second shot the following month when he will be 18-year-old. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of 17-year-old male with Product administered to patient of inappropriate age for mRNA-1273, lot # 031L20A with no associated adverse events. Event considered resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/15/2021,0.0,UNK,,Penicillin allergy,,,,['Product administered to patient of inappropriate age'],1,MODERNA, 1074391,PA,,F,"syringe broke, so the nurse readministered another entire dose; syringe broke, so the nurse readministered another entire dose; dry mouth; arm extremely sore; A spontaneous report was received from a from a consumer and concerning a 36 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dry mouth and her arm extremely sore. The patient's medical history was not provided. No relevant concomitant medications were reported. On 21 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 lot: 012L20A intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 9 Feb 2021 prior to the onset of the events, the patient received their second dose of mRNA-1273 lot: D32L20A intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 19 Feb 2021, The patient experienced the events as dry mouth and her arm extremely sore Before taking the second dose the syringe broke, so the nurse readministered another entire dose in the same arm (left arm). and she doesn't know if it belongs to both doses or to which dose it belongs to. Laboratory details not provided. Treatment details not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of events dry mouth and her arm extremely sore was unknown and for syringe issue and extra dose administered was considered as recovered.; Reporter's Comments: This case concerns a 36 Y/O F with NS unexpected events of syringe broken and extra dose administered for mRNA-1273 lot # D32L20A, with associated adverse events of NS unexpected dry mouth and NS expected vaccination site pain. Events occurred the same day as second dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,02/19/2021,29.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Dry mouth', 'Extra dose administered', 'Syringe issue', 'Vaccination site pain']",2,MODERNA,OT 1074392,NJ,,F,"Sore arm; Feels that did not received the full vaccine; The syringe did not enter to the muscle, but entered to the fat; A spontaneous report, was received from a consumer (patient), female adult patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced sore arm (pain in extremity), feels that did not received the full vaccine (underdose), and the syringe did not enter to the muscle, but entered to the fat (incorrect route of product administration). The patient's medical history was not reported. Concomitant medications were not reported. On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot number: 029L20A), intramuscularly for the prophylaxis of COVID-19 infection. On 15 Feb 2021, prior to the onset of the events, the patient received their second planned doses of mRNA-1273 (lot number: 004M20A), into the arm for the prophylaxis of COVID-19 infection. On an unknown date in Feb 2021, the patient experienced sore arm, and feels that did not received the full vaccine. The patient noticed that the nurse who administered her the vaccine squeezed the arm before giving the vaccine, and it seems that the syringe did not enter to the muscle but entered to the fat. The patient states that, between the two doses, took an antibody test, with a negative result. The patient inquires if she can take another antibody test and if she can receive a third dose to ensure more protection. No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the events was not applicable. The outcome of the event, sore arm was reported as unknown, that of events feels that did not received the full vaccine, the syringe did not enter to the muscle, but entered to the fat, were considered as recovered on an unknown date in Feb 2021.; Reporter's Comments: This case concerns a female who had nonserious unexpected events of incorrect route of product administration for the second dose of mRNA-1273 (lot # 029L20A) with associated adverse events of underdose and pain in extremity. The adverse events occurred with unknown latency. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,02/01/2021,11.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No relevant medical history),,,"['Antibody test', 'Incorrect route of product administration', 'Pain in extremity', 'Underdose']",1,MODERNA,OT 1074393,WI,80.0,F,"Partial dose of 0.3ml as 2nd dose; 1st shot of Pfizer and second shot of Moderna COVID 19 Vaccine; A spontaneous report was received from a other health professional (nurse) concerning a 80-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273), received 1st shot of Pfizer and was given 2nd shot of Moderna COVID vaccine which was partial dose of 0.3ml. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, the patient received the first dose of Pfizer. On 19 Feb 2021, the patient received their doses of mRNA-1273 (041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 19 Feb 2021, patient received 1st shot of Pfizer and was given 2nd shot of Moderna COVID vaccine which was partial dose of 0.3ml. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event patient received 1st shot of Pfizer and was given 2nd shot of Moderna COVID vaccine which was partial dose of 0.3ml was considered resolved.; Reporter's Comments: This report refers to a case of under dose, wrong product administered for mRNA-1273, lot # 041L20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical History not provided),,,"['Underdose', 'Wrong product administered']",1,MODERNA,OT 1074394,WI,78.0,F,"Partial dose of 0.3ml as 2nd dose; 1st shot of Pfizer and second shot of Moderna COVID 19 Vaccine; A spontaneous report was received from a other health professional (nurse) concerning a 78-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273), received first vaccination of Pfizer vaccine and was given second vaccination of Moderna COVID vaccine which was a partial dose of 0.3ml. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, the patient received the first vaccination dose of Pfizer vaccine. On 19 Feb 2021, the patient was given a second vaccination dose of mRNA-1273 (041L20A) intramuscularly for prophylaxis of COVID-19 infection, which was a partial dose of 0.3 ml of Moderna COVID vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event patient received first vaccination of Pfizer and was given a second vaccination of Moderna COVID vaccine which was partial dose of 0.3ml was considered resolved.; Reporter's Comments: This report refers to a case of wrong product administered and accidental underdose for mRNA-1273, lot # 041L20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Accidental underdose', 'Wrong product administered']",1,MODERNA,OT 1074395,CA,72.0,M,"Arm ache; Patient received 3/4 of the dose; A spontaneous report was received from a consumer concerning a 72-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273), received 3/4 of the vaccine and the rest went to the floor and the patient experienced arm ache. The patient's medical history was not provided. Concomitant medications included Eliquis, unspecified blood pressure medicine and low dose aspirin. On 20 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(Batch Number 043L20A), unknown route for prophylaxis of COVID-19 infection. On 20 Feb 2021, the patient received 3/4 of the vaccine and the rest went to the floor. On an unknown date, the patient experienced arm ache. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event received 3/4 of the vaccine and the rest went to the floor was considered recovered. The outcome of the event arm ache was not reported.; Reporter's Comments: This report refers to a case of accidental underdose for mRNA-1273, lot # 043L20A, with associated adverse event. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/20/2021,0.0,UNK,ELIQUIS; ASPIRINE,,Medical History/Concurrent Conditions: No adverse event (Medical History not provided),,,"['Accidental underdose', 'Pain in extremity']",1,MODERNA,OT 1074396,NY,,F,"Fluid on her arm (droplet); Didn't receive the entire dose; A spontaneous report, was received from a consumer (patient), a 61 years-old white female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced fluid on her arm (droplet) (vaccination site extravasation), and didn't receive the entire dose (incorrect dose administered). The patient's current conditions included hypertension and allergies. Concomitant medications reported included lisinopril and unspecified allergy tablet. On 09 Feb 2021, prior to the onset of the events, the patient received their second planned doses of mRNA-1273 (lot number: 010M20A), intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 09 Feb 2021, after the vaccination, the patient experienced that there was fluid on arm (droplet), and the nurse wiped it off. The patient stated that the nurse also attempted to place a band aid over the injection area, but the site was moist, and the band aid wouldn't stick. The patient was concerned if she didn't receive the entire dose. No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the events was not applicable. The outcome of the event, fluid on her arm (droplet) was unknown, and didn't receive the entire dose was considered as recovered on 09 Feb 2021.; Reporter's Comments: This report refers to a case of a 61-year-old female with Vaccination site extravasation and Incorrect dose administered for the second dose of mRNA-1273 (lot # 010M20A) with no associated adverse events. Events considered resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,UNK,LISINOPRIL,Allergy; Hypertension,,,,"['Incorrect dose administered', 'Vaccination site extravasation']",2,MODERNA,OT 1074397,,17.0,M,"Vaccine given to 17 year old; A spontaneous report was received from a registered nurse concerning a 17 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No concomitant product use was reported. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient returned for the second dose and the mistake that the vaccine was given to a 17 year old male had come to light. Treatment information was not applicable. The second dose of mRNA-1273 was discontinued in response to the event. The outcome of the event was considered resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a 17-year-old male who experienced a nonserious unexpected event of Product administered to patient of inappropriate age for first dose mRNA-1273 (lot # 011J20A) with no associated adverse events. The second dose of mRNA-1273 was not administered. Event considered resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1074401,PR,100.0,F,"General malaise, acetaminophen was gives every 6 to 8 hours",Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,02/25/2021,02/26/2021,1.0,SEN,"Plavix 75mg, lmdur 30mg, Norvasc 2.5mg, Losartan50mg, Xanax 1m",,"HBP, heart disease, colostomy",,"Aspirin, Penicillin, Shell fish",['Malaise'],1,MODERNA,IM 1074405,MD,48.0,M,"Approximately 12 hours after getting the vaccine, I began shivering uncontrollably for about an hour and felt hot (like a fever) at the same time. I also ached all over. I took 2 Tylenol and was able to fall back asleep. I woke up sweaty, but the chills and fever were gone. I?m now just stiff, with some mild pain at the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/05/2021,1.0,OTH,1) Diovan; 2) Amlodipine; 3) multi-vitamin,None,Polycystic kidney disease.,,Penicillin.,"['Chills', 'Feeling hot', 'Hyperhidrosis', 'Injection site pain', 'Musculoskeletal stiffness', 'Pain']",1,JANSSEN,SYR 1074432,MD,76.0,M,Patient with history of TIA one week prior presented to the ED for recent onset of fever and epigastric abdominal pain. Pt found to have calculus of bile duct with acute cholecystitis and obstruction. In Ed pt had fever as high as 104 and pulse as high as 129. The gallbladder was found to be distended with wall thickening and large gallstone in the lumen. Patient transferred to tertiary care facility.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/17/2021,02/24/2021,7.0,PVT,,Possible TIA (2/15),GERD,,"Ciprofloxacin, sulfa","['Abdominal pain upper', 'Biliary obstruction', 'Cholecystitis acute', 'Cholelithiasis', 'Gallbladder enlargement', 'Heart rate increased', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1074434,MO,66.0,M,"woke up with fever, chills, joint aches, headache, general malaise",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/05/2021,1.0,PHM,"Lisinopril, 5 mg daily allopurinol, 400 mg daily Celebrex, 200 mg daily Fentanyl,, 150 ug/hr X 3 days Mulitvitamin Calcium + D3 1250 mg/200 U Vitamin D3, 1000 U Senna/docusate - 8.6/50 mg - daily ASA - 325 mg daily Miralaz - 17 g, daily",,DISH Renal cell carcinoma Gout,,"Keflex, milk","['Arthralgia', 'Chills', 'Headache', 'Malaise', 'Pyrexia']",1,JANSSEN,IM 1074435,KY,70.0,M,"today he presents with complaints of dyspnea at rest, associated with a cough, abdominal and scrotal edema and bilateral leg edema. He also reports getting his 2nd COVID vaccine yesterday which causes him to have a 102 temperature and worsening cough. He reports a 30lb weight gain since January. He was on tikosyn for AF rate control which was recently stopped, but he was unsure why. He was regularly using CPAP machine, but stopped using about last year due to concerns with coronavirus. He was previously active going to the gym which she is also stopped during the pandemic due to inaccessibility",Not Reported,,Not Reported,Yes,,Not Reported,N,03/03/2021,03/05/2021,2.0,PVT,Spironolactone Potassium Albuterol Norvasc Eliquis Lipitor Avapro Singulair Januvia Demadex Nasacort,Pulmonary Edema Acute on chronic congestive heart failure,CHF Atrial fibrillation HTN DM Cardiomypoathy HLD Obesity OSA with CPAP Scoliosis Skin Cancer GERD CAD Arthritis Asthma,,Oxycodone,"['Abdominal wall oedema', 'Body temperature increased', 'Cough', 'Dyspnoea', 'Oedema peripheral', 'Peripheral swelling', 'Pyrexia', 'Scrotal oedema', 'Weight increased']",2,PFIZER\BIONTECH,IM 1074473,CT,28.0,F,Extreme muscle aches and joint pain to the point of barely being able to move Chills Sweats Burning/Irritated Skin Nausea Thirst,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/03/2021,03/03/2021,0.0,PVT,Sertraline Syeda Proair Probiotic vitamins,None,Depression Exercise induced asthma,,Amoxicillan,"['Arthralgia', 'Chills', 'Hyperhidrosis', 'Mobility decreased', 'Myalgia', 'Nausea', 'Skin burning sensation', 'Skin irritation', 'Thirst']",,JANSSEN,SYR 1074476,OH,24.0,F,"Severe chills, headache, and body aches starting approximately 5.5 hours post-vaccination. Treated with acetaminophen 1g PO. Fatigue, headache, and dizziness beginning the following morning and persisting until approximately 9pm on 3/4/21. Treatment with acetaminophen every 6 hours as needed. After 9pm on 3/4/21, complete resolution of symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/03/2021,03/03/2021,0.0,PHM,"sertraline 50 mg HS Kelnor 1/35, 1 tab daily melatonin 300 mcg HS",none,"cerebral palsy, anxiety",,"Sulfa- rash, headache, flushing","['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Pain']",1,JANSSEN,IM 1074480,MD,86.0,M,"Patient was found sitting in his driveway around 4pm, dizzy with incontinent stool and vomiting. He was brought to ED where he was found to have skull fracture and SAH. Patient was admitted to the hospital . Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine. This hospitalization does not appear to be related to the vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,,02/09/2021,02/23/2021,14.0,PVT,,,ckd,,sulfa,"['Anal incontinence', 'Dizziness', 'Skull fracture', 'Subarachnoid haemorrhage', 'Vomiting']",UNK,PFIZER\BIONTECH, 1074536,CO,65.0,M,Patient with ascending sensory deficits consistent with AIDP. No weakness or respiratory weakness but areflexic. PLEX started on 3/4. Sensory symptoms stable. Still inpatient,Not Reported,,Not Reported,Yes,6.0,Yes,Y,02/28/2021,03/01/2021,1.0,MIL,"carvedilol 12.5 mg bid, Alprostadil IM PRN for ED, prednisone 10 mg qD, Insulin NPHY 35U qAM, dabigatran 150 mg bid, finasteride 5 mg qD, dulaglutide 1.5 mg qWeek, spironolactone 25 mg qD, Flonase daily PRN, fluconazole 150 mg, tamsulosin",,"Diabetes, HTN, MDD, LE Edema, HFrEF, AFib, OSA, diabetic retinopathy","AIDP after flu vaccine (Fluzone HD; Sanofi Pasteur; Lot UJ478AA, Exp 6/30/21)","Atorvastatin-> memory impairment, keflex ->Rash, metoprolol-> Rash, doxazosin-> Hypotension","['Antibody test', 'Areflexia', 'Guillain-Barre syndrome', 'Lumbar puncture', 'Plasmapheresis', 'Sensory loss']",1,PFIZER\BIONTECH,IM 1074547,LA,68.0,F,"found by husband with AMS on 3/4/21, not responding to questions or following commands. taken to the ER- fever 101.2, HR elevated, decreased BP",Not Reported,,Not Reported,Yes,,Not Reported,U,03/03/2021,03/04/2021,1.0,PVT,Levothyroxine,COVID-19 positive in November 2020,,,NKDA,"['Blood culture', 'Blood lactic acid increased', 'Blood pressure decreased', 'Chest X-ray abnormal', 'Computerised tomogram head', 'Computerised tomogram head normal', 'Heart rate increased', 'Hyporesponsive to stimuli', 'Influenza virus test negative', 'Mental status changes', 'Pyrexia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 1074549,CT,77.0,M,Two days after receiving the vaccine the patient began experiencing shortness of breath. One week after onset of symptoms he presented to the hospital and was diagnosed with submassive pulmonary embolism. He underwent IR suction thrombectomy which removed 30% of the PE burden and spent two days in the ICU. He has now been transferred to the floor.,Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/21/2021,02/23/2021,2.0,PVT,"Amlodipine, benazepril, rosuvastatin, tamsulosin, famotidine, Ventolin inhaler, cholecalciferol/Vitamin D3, Vitamin B12, latanoprost ophthalmic solution, turmeric oil",,"benign prostatic hypertrophy, hyperlipidemia, hypertension",,"Corn, peanut, shellfish","['Angiogram', 'Angiogram pulmonary abnormal', 'Brain natriuretic peptide increased', 'Dyspnoea', 'Echocardiogram', 'Echocardiogram abnormal', 'Pulmonary embolism', 'Thrombectomy', 'Troponin increased']",2,PFIZER\BIONTECH, 1074566,MD,29.0,F,Itchiness all over the body,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/01/2021,03/05/2021,4.0,PUB,,,,,Peanuts,['Pruritus'],1,JANSSEN,IM 1074569,MN,79.0,F,Patient received second dose of Moderna Covid vaccine at 0930 on 3/4/21 and presented to ED at 1800 on 3/4/2021 with complaint of weakness and not being able to get out of recliner. Patient was admitted to hospital under observation stay. The following meds were started: pantoprazole 40 mg IVP once and normal saline at 100 mL/hr (ran for 7.5 hours = 750 mL). Patient returned back to her baseline by approximately 1400 on 3/4/21.,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,03/04/2021,03/04/2021,0.0,PVT,"allopurinol, bumetanide, calcitriol, hydrocortisone cream, diltiazem XR, fexofenadine, warfarin, levothyroxine, metformin, metolazone, metoprolol succinate, omeprazole, oxycodone/APAP, potassium chloride, pravastatin, vanicream topical",no known other illnesses,"atrial fibrillation, diastolic heart failure, metabolic syndrome, hypertensive disorder, edema, hypokalemia, cataract, hypercholesterolemia, lumbosacral spondylosis, cervical spondylosis, acquired scoliosis, CKD stage 4, anxiety, vitamin B deficiency, disorder of magnesium metabolism, morbid obesity, CHF, osteoarthritis of knee, hypothyroidism, paroxysmal ventricular tachycardia, cardiomegaly",,"latex, nickel, sulfa antibiotics","['Asthenia', 'Blood albumin decreased', 'Blood creatinine increased', 'Blood glucose increased', 'Blood osmolarity increased', 'Blood osmolarity normal', 'Blood urea increased', 'Carbon dioxide increased', 'Globulins increased', 'Metabolic function test', 'Mobility decreased', 'Troponin normal']",2,MODERNA,IM 1074595,MA,,F,"Atrial fibrillation; Fast heartbeat; A spontaneous report was received from a consumer, an 83 year-old female patient, who received Moderna's Covid-19 vaccine (mRNA 1273), and who experienced atrial fibrillation and fast heartbeat/heart rate increased. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included thyroid medications and medications for poor blood flow (not specified). On 14-FEB-2021, approximately 12 hour prior to the onset of symptoms, the patient received first of two planned dose of mRNA-1273 (Batch Number -011MZ0A) intramuscularly for prophylaxis of Covid-19 infection. On 14-FEB-2021 the patient went to an emergency room due to fast heartbeat and atrial fibrillation. The treatment for the event included tachycardia converser. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, atrial fibrillation and fast heartbeat, were considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/14/2021,02/14/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history provided.),,,"['Atrial fibrillation', 'Heart rate increased']",1,MODERNA,OT 1074596,NJ,,F,"She was given the vaccine intramuscularly in her glute; A spontaneous report was received from a consumer concerning a 79-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was given the vaccine intramuscularly in her glute. The patient's medical history included breast cancer. There was no concomitant medication provided. On 23-feb-2021, approximately prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 022M20A) intramuscularly in the glute for prophylaxis of COVID-19 infection. On 23-Feb-2021, due to her medical history of breast cancer she was unable to receive the vaccine in either of he arm. The patient was given the vaccine intramuscularly in her glute. There was no treatment information provided. Action taken with mRNA-1273 in response to the events was not reported. The events, She was given the vaccine intramuscularly in her glute were considered as recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # 022M20A) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2010,,UNK,,,Medical History/Concurrent Conditions: Breast cancer female,,,['Incorrect route of product administration'],1,MODERNA,OT 1074597,AZ,,M,"loosing blood in his stool; feeling weaker and weaker; feeling weaker; A spontaneous report was received from a consumer who is also a 76-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced weakness worsened/ asthenia and loosing blood in his stool/ hematochezia. The patient's medical history included blood disease, some type of anemia, and a heart condition. 09 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025320-24) intramuscularly for prophylaxis of COVID-19 infection. The patient was feeling weaker, which started before the vaccine, and he took iron and it got a little better. The patient was also loosing blood in his stool. Action taken with the drug in response to the events were not reported. The outcome of the event, asthenia, was improved. The outcome of the event, hematochezia, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,,,UNK,,Anemia (He has some type of anemia where his cells are not as large.); Blood disorder; Heart disorder; Weakness,,,,"['Asthenia', 'Condition aggravated', 'Haematochezia']",1,MODERNA,OT 1074598,MS,,M,"little bit sore; possible Bell's Palsy; left side of his face was swollen; Couldn't open his mouth; A Spontaneous case report was received from a consumer concerning a 67 year old male patient ,who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced swelling face, facial paralysis, couldn't open his mouth and pain. The patient medical history, as provided by the reporter, included hypertension and type 2 diabetes. On 13-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(Lot number:024M20A) in the left arm for prophylaxis of COVID-19 infection. On 13-FEB-2021, the patient felt his left side of his face was swollen, and he couldn't open his mouth. On 17-FEB-2021 he went to emergency room and diagnosed with possible Bells palsy. Lab tests was done: x-ray and imaging and couldn't find anything. On 26-FEB-2021 he also felt little bit sore. No treatment was given for the events. Action taken with mRNA-1273 in response to the events was unknown. The events ,swelling face, facial paralysis, couldn't open his mouth were considered resolving on 26-FEB-2021 and pain was considered as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/13/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Hypertension; Type 2 diabetes mellitus,,,"[""Bell's palsy"", 'Dyskinesia', 'Pain', 'Swelling face', 'X-ray']",1,MODERNA,OT 1074599,MN,,M,"Death; A spontaneous report was received from a other health care professional concerning a 57-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and died. The patient's medical history included chronic obstructive pulmonary disease (COPD). Concomitant product use was not provided. On 02 Feb 2021, prior to onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 043L20A) in the left arm for prophylaxis of Covid-19 infection. 03 Feb 2021, it was reported that the patient died. The patient was not experiencing any symptoms prior to death. He was on hospice care, not hospitalized. No further information was provided. Treatment information was unknown. The cause of death was not reported. Plans for an autopsy were unknown. Action taken with the mRNA-1273 in response to the event was not applicable.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown",Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/03/2021,1.0,OTH,,COPD,Medical History/Concurrent Conditions: Hospice care,,,['Death'],1,MODERNA, 1074605,MT,73.0,U,"After Pfizer COVID vaccine, patient was monitored for 15 minutes. Upon standing up, patient complained of headache and flushing and was transported to the ER. He proceeded to complain of jaw pain that radiated into chest. EKG performed was significant for STEMI. Patient was transported immediately to cath lab and received 3 drug eluting stents to L main/ramus, LAD, and L Cx. Other past medical history significant for hyperlipidemia, hypothyroidism, and remote history of obstructive sleep apnea.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/27/2021,02/27/2021,0.0,PVT,,,,,,"['Acute myocardial infarction', 'Chest pain', 'Electrocardiogram', 'Electrocardiogram abnormal', 'Flushing', 'Headache', 'Pain', 'Pain in jaw', 'Stent placement']",UNK,PFIZER\BIONTECH, 1074631,NJ,70.0,M,Little chills - fatigue nothing severe but there,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/04/2021,03/05/2021,1.0,PHM,Afluozin Vitamin C Vitamin D,prostate cancer,none,,none,"['Chills', 'Fatigue']",UNK,JANSSEN, 1074633,VA,77.0,F,She was diagnosed with Transverse Myelitis,Not Reported,,Not Reported,Yes,3.0,Yes,N,02/20/2021,02/23/2021,3.0,SCH,"Clonidine, Valsartan, Metropolo, Simvastatin, Levothyroxine",,high blood pressure thyroid,,"Sulfa, codene",['Myelitis transverse'],2,MODERNA,SYR 1074671,MI,85.0,F,Generalized weakness to the extent she could not walk unassisted or speak clearly. Fatigue Incontinence (perhaps as result of weakness and fatigue) bowel and bladder not usual in this individual.,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/26/2021,02/27/2021,1.0,SEN,"Metforma, insulin, diltiazem, elequis, hydrozyurea, ASA, Fosamax, namenda, aricept, seroquel,",,"Diabetes, afib, dementia",,None,"['Asthenia', 'Bladder disorder', 'Blood glucose normal', 'Blood pressure normal', 'Computerised tomogram abdomen normal', 'Computerised tomogram head normal', 'Computerised tomogram pelvis abnormal', 'Fatigue', 'Gait disturbance', 'Gastrointestinal motility disorder', 'Incontinence', 'Laboratory test normal', 'Speech disorder']",2,MODERNA,IM 1074701,LA,56.0,F,within a minute of receiving the vaccine I started feeling dizzy and woozy and like I was floating. Then my blood pressure went up and my heart started beating faster. I had tightness in my chest and I got a tickle like feeling at the top of my chest. I got nauseous. BP was elevated (140/85) normal 107/65. I stayed for an hour. I was very very sleepy the whole time. 3/5/21 I still have the tickle and tightness and pressure on my chest and I am having vertigo attacks. I got a headache and pain and stiffness in my neck where I have had nerve pain injections and ablations.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/04/2021,0.0,OTH,Phem ring testosterone levothyroxine iron supplement similasan Baclofen (haven't taken in a month and only take it as needed) Clonazepam,NO,Chronic Eye Pain Syndrome Chronic Bilateral Planterfacitis PTSD Vit D Deficiency High Cholesterol Tibial Tendonitis in both legs tendinopathy in both shoulders Jackhammer esophagus Chronic pain in my head Chronic Migraines,tetanus: arm swelled up and was painful.,Propylene Glycol ALL GLYCOL Alcohol Epinephrine latex sulfa drugs Black Pepper Mite Oats Coconut and anything coconut derived formaldehyde Oak Pollen Ragweed Soy Coffee Walnuts Blueberries propranolol Bactrim Macrobid doxycycline tetracycline sodium extended naproxen spiders fire ants aloe mold any phenols and fragrances metoprolol succinate Montelukast tizanidine nickel dexamethasone pregavilin artificial sweeteners pecans almonds,"['Blood pressure increased', 'Chest discomfort', 'Dizziness', 'Feeling abnormal', 'Headache', 'Heart rate increased', 'Musculoskeletal stiffness', 'Nausea', 'Neck pain', 'Somnolence', 'Vertigo']",1,JANSSEN,SYR 1074703,OH,62.0,F,"8 hours after getting the vaccine I started feeling very cold. It came on me all of a sudden. Shaking, shivering, teeth chattering ensued along with generally feeling very unwell. (Similar to how I felt years ago after having surgery) This progressed during the night to fever, chills, extreme body aches, stabbing pains in the head, heart racing, dizziness and nausea. After 12 hours I started to feeling improvement. At the 16 hour mark I am really tired and nauseous but feel like I'm coming back. Probably the worst I've ever felt. We considered going to the ER in the night.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/04/2021,03/04/2021,0.0,PHM,"topical tacrolimus (very small smear), diclofenac sodium, magnesium, b6, calcium, fish oil capsule, d3",no other illness,"Erosive lichen planus, spinal disease, severe osteoarthritis, ventricular arrhythmia",,"many sensitivities to drugs, etc. Over reaction vs general population. Labeled Medication sensitive. Recent inflammatory reaction to petroleum based topical prescription drug preparations.","['Chills', 'Dizziness', 'Fatigue', 'Feeling cold', 'Headache', 'Malaise', 'Nausea', 'Pain', 'Palpitations', 'Pyrexia', 'Tremor']",UNK,JANSSEN,IM 1074707,TX,25.0,F,"Vaccine administered at 8:53am. After injection, patient noted immediate itching at site of injection that progressed to hand but was not initially alarmed and did not inform staff. Subsequently developed sweaty palms and back of neck. She notified staff of symptoms when noted swelling in throat. 9:09am BP 127/79, P79, O2 Sat 100% Epinephrine 0.5 mg IM administered at 9:12am 9:13am BP 122/87, P 71, O2 Sat 100% 9:15am reports resolution of above symptoms and now only complains of dry mouth and feeling a little jittery 9:18am 118/81, 75, 99% 9:31 am resting comfortably, drinking fluids, jitteriness improving, no other symptoms. Given 25 mg Benadryl PO. 9:50 am complains of HA, bilateral temporal, described as achy, 2/10 intensity. 9:53 Ibuprofen 400mg PO Will be observed for 4 hours in clinic.",Not Reported,,Yes,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,SCH,flonase Vit D,none,none,,"tree nuts, shellfish and seafood, dust mites, pollen, pet dander","['Dry mouth', 'Feeling jittery', 'Headache', 'Hyperhidrosis', 'Immediate post-injection reaction', 'Injection site pruritus', 'Pharyngeal swelling', 'Pruritus']",1,MODERNA,IM 1074753,RI,79.0,F,Pt. had a cardiac arrest and expired on 2/20/21.,Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/20/2021,9.0,OTH,Lisinopril 20mg/ HCTZ 25mg,,"HTN, CAD, OAD, Brian Aneurysm, osteoporosis, GERD, post cardiac arrest 1/2021, MI",,NKA,"['Cardiac arrest', 'Death']",1,MODERNA,IM 1074773,MA,65.0,F,"Pt received J/J vaccine at location yesterday (3/4/21) at 11am. She noticed a fever at around 3pm. She had a fever to 104-105 all during the night, she was 99 this am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,PVT,"as listed in Epic Buproprion, Multivitamen, Omega 3 100 mg, Raloxifene 60 mg, Ranitidine, Valacyclovir",Procedure with Botox for Adductor Spasmodic Dysponia on 1/19/21,,,"Fluoxetine, Erythromycin, Ibuprofen, Penicillins, Bactrim",['Pyrexia'],1,JANSSEN,IM 1074784,GA,82.0,F,Nurse called clients' son to remind her of the second dose needed and was informed that client had passed away from Pneumonia the Sunday after she received the vaccine 1/17/2021.,Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,N,01/14/2021,01/15/2021,1.0,PUB,Not applicable,Pneumonia,Not aware,,None voiced,"['Condition aggravated', 'Death', 'Pneumonia']",1,MODERNA,IM 1074788,,24.0,F,"At 8 weeks pregnancy (2 weeks after first shot) started bleeding and had a subchorionic hematoma. By 10 week subchorionic hematoma resolved. Received second shot and of Feb. 1 week later, at 12 weeks pregnancy , fetus had no heart beat! It measured normal size (as expected) and limited normal first trimester anatomy by ultrasound. But NO heart beat. Something insulted this placenta to lead to fetal demise.",Yes,,Not Reported,Not Reported,,Not Reported,,02/01/2021,03/04/2021,31.0,UNK,no,no,no,,no,"['Exposure during pregnancy', 'Foetal death', 'Foetal heart rate abnormal', 'Placental disorder', 'Ultrasound antenatal screen abnormal']",UNK,PFIZER\BIONTECH, 1074822,IA,46.0,F,"Dizziness, lightheadedness, chest pain, increased respiration, gagging",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/05/2021,03/05/2021,0.0,WRK,Not known,"Anxiety, migraines",Anxiety,,Nka,"['Chest pain', 'Dizziness', 'Respiratory rate increased', 'Retching']",1,JANSSEN,IM 1074833,IL,75.0,F,"Office visit - NP Chief Complaint: seen today, 3/4/2021, complaining of or following up for Fever (started today), Nausea (has nausea today), Abdominal Pain (c\o upper and lower abd pain has been constant for the last 3 days started on monday), Diarrhea (states she had diarrhea all day yesterday but has had no bm today), and Fatigue (pt states she is feeling very week today) . HPI Patient comes in to the office complaining of severe abdominal pain. States the pain started on Monday and was less severe, stating the pain has escalated to a 9/10 today and ""unbearable."" Pt. States she had diarrhea for a 24 hour period yesterday, but denies any bowel movement today. Patient also complains of severe fatigue and states nausea with emesis a ""few times over the last 4 days."" Patient states that on Tuesday her pain became ""a little better,"" but states since that time it has worsened and is severe at approximately 1230 this morning."" Patient states she did not go to the ER because she ""knew she had an appointment today."" BP 134/84 Pulse 104 Temp 101.6 �F (38.7 �C) Resp 20 SpO2 94% Abdominal: General: There is distension. Palpations: Abdomen is rigid. Tenderness: There is generalized abdominal tenderness. There is guarding and rebound. Comments: Tinkling bowel sounds noted to RLQ and RUQ with hypoactive bowel sounds to LUQ and LLQ. Abdomen is rigid and guarding and rebound pain are noted with examination. triaged to Emergency room: HPI 75 y.o. female who presents with complaints of right upper quadrant pain since Monday reports is moderate to severe sharp better right upper quadrant without radiation better with rest and worse with movement � FINAL IMPRESSION � � ICD-10-CM ICD-9-CM 1. Calculus of gallbladder and bile duct with acute cholecystitis without obstruction K80.62 574.60 2. Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (HCC) A41.9 038.9 � � 995.91 � Final Disposition Transfer to Another Facility current inpatient at Hospital",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/24/2021,03/04/2021,8.0,PVT,"Current Outpatient Medications: ? amLODIPine (NORVASC) 5 MG tablet, Take 1 tablet (5 mg) by mouth 2 times daily, Disp: 180 tablet, Rfl: 3 ? Blood Glucose Monitoring Suppl (EASY TOUCH HEALTHPRO SYSTEM) W/DEVICE KIT, , Disp: , Rfl: 0 ? cl",,,,Allergen Reactions ? Sulfa Antibiotics Shortness Of Breath �,"['Abdominal distension', 'Abdominal pain', 'Abdominal pain lower', 'Abdominal pain upper', 'Abdominal rebound tenderness', 'Abdominal rigidity', 'Abdominal tenderness', 'Alanine aminotransferase normal', 'Albumin globulin ratio normal', 'Amylase normal', 'Aortic arteriosclerosis', 'Arteriosclerosis coronary artery', 'Aspartate aminotransferase normal', 'Asthenia', 'Bacterial test', 'Bilirubin urine', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bilirubin increased', 'Blood calcium normal', 'Blood chloride decreased', 'Blood creatinine increased', 'Blood gases', 'Blood glucose increased', 'Blood lactic acid', 'Blood lactic acid abnormal', 'Blood potassium normal', 'Blood sodium decreased', 'Blood urea increased', 'Blood urine absent', 'Blood urine present', 'Carbon dioxide abnormal', 'Chest X-ray abnormal', 'Cholecystitis acute', 'Cholelithiasis', 'Computerised tomogram abdomen', 'Culture urine', 'Diarrhoea', 'Differential white blood cell count abnormal', 'Diverticulum intestinal', 'Fatigue', 'Full blood count abnormal', 'Gastrointestinal sounds abnormal', 'Glomerular filtration rate decreased', 'Glucose urine absent', 'Glucose urine present', 'Haematocrit increased', 'Haemoglobin increased', 'Hiatus hernia', 'Influenza A virus test negative', 'Influenza virus test negative', 'Lipase normal', 'Lymphocyte count', 'Lymphocyte percentage decreased', 'Mean cell haemoglobin concentration normal', 'Mean cell volume normal', 'Mean platelet volume normal', 'Monocyte count increased', 'Monocyte percentage', 'Nausea', 'Neutrophil count increased', 'Neutrophil percentage increased', 'Nitrite urine absent', 'Platelet count', 'Protein total normal', 'Protein urine absent', 'Protein urine present', 'Pulmonary granuloma', 'Pyrexia', 'Red blood cell count increased', 'Red blood cell morphology normal', 'Red blood cell nucleated morphology', 'Red blood cells urine negative', 'Red cell distribution width normal', 'SARS-CoV-2 test negative', 'Sepsis', 'Spinal osteoarthritis', 'Umbilical hernia', 'Urinary sediment present', 'Urine analysis abnormal', 'Urine ketone body absent', 'Urine leukocyte esterase', 'Urobilinogen urine', 'Uterine leiomyoma', 'Vomiting', 'White blood cell count increased', 'White blood cells urine positive', 'pH urine normal']",2,MODERNA,IM 1074845,MN,27.0,F,"Later in the evening after receiving the vaccine, I experienced a very strong and pounding headache. I took some Ibuprofens and went to sleep around 9pm and the headache was resolved around 11:30pm. However, later during the night the headache came back. Also, my body aches all over and just generally uncomfortable feelings. The injection site felt warm to the touch and sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/04/2021,0.0,WRK,"Zoloft, Adderall, oral birth control pills",None,None,,None,"['Discomfort', 'Headache', 'Injection site pain', 'Injection site warmth', 'Pain']",1,JANSSEN,SYR 1074871,MI,26.0,F,Severe thrombocytopenia Petichiae,Not Reported,,Not Reported,Yes,,Not Reported,N,01/12/2021,02/19/2021,38.0,PUB,Motrin,none,none,,none,"['Petechiae', 'Platelet count decreased', 'Thrombocytopenia']",2,MODERNA,SYR 1074873,MD,82.0,F,"Patient had COVID pneumonia in January 2021. Readmitted 2/10 for nausea/vomiting found to be in DKA. Treated with IV insulin, fluids, pressors and admitted to ICU. DKA resolved but continued to have ongoing nausea and dysphagia. EGD showed possible candidiasis, GI symptoms started to improve and was discharged home 2/24 with O2, life care, home health care. Patient recorded deceased 02/26/2021.",Yes,02/26/2021,Not Reported,Yes,,Not Reported,,12/29/2020,02/10/2021,43.0,PVT,,recent COVID-19 pneumonia 1/2021,"COPD, atrial fibrillation, diabetes mellitus, GERD, hypertension, hyperlipidemia, coronary artery disease, aortic stenosis,",,"lisinopril, sodium hypochlorite, tetanus toxoid, tuberculin.ppd","['COVID-19 pneumonia', 'Death', 'Diabetic ketoacidosis', 'Dysphagia', 'Gastrointestinal disorder', 'Intensive care', 'Nausea', 'Oesophagogastroduodenoscopy', 'Vomiting']",1,PFIZER\BIONTECH,IM 1074894,NY,94.0,M,Patient became ill with pneumonia on 1/29/21 and then recurrent pneumonia on 2/10/21. Pt's plan of care was subsequently changed to comfort-focused on 2/11/21 and patient was deceased that same day.,Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,N,01/26/2021,02/11/2021,16.0,SEN,"Eliquis, Metoprolol succinate, Upcal w/Vitamin D, senna, levothyroxine, vitamin D3",None,"Cerebrovascular disease, vascular dementia, ASCVD, CAD, PVD, HTN, CHF, Afib, Hyperlipidemia, DMII, Hypothyroidism, OA, DJD, DDD, gout, CKD stage 3a, BPH, GERD, Vitamin D deficiency, osteopenia",,"Bactrim DS, Zetia, Flomax, Crestor, Proscar","['Blood chloride increased', 'Blood chloride normal', 'Blood creatinine increased', 'Blood sodium increased', 'Blood urea increased', 'Death', 'Glomerular filtration rate normal', 'Influenza A virus test negative', 'Influenza virus test negative', 'Pneumonia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 1074903,AL,90.0,M,caller (son) stayed w/ the pt for about an hour after he received the vax and the pt stated the only symptoms at that time was some achiness on the arm around the injection site. Son went home after that. He tried to contact him on 3/1/2021 but wasn't able to reach him. On 3/2/21 the brother tried to contact him and wasn't able to reach him. They contacted the police dept on 3/2/2021 around 8:00 AM to do a well check. Pt was found on the couch like he had fallen asleep but was deceased. They suspect he probably expired on 3/1/2021. No autopsy will be conducted per the son.,Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,N,02/27/2021,03/01/2021,2.0,SCH,numerous dietary supplements and herbal meds,no,"Peripheral Artery Disease, HBP, Chlorestoral,",,no,"['Death', 'Injection site pain']",1,PFIZER\BIONTECH, 1074923,,,F,"Flare up throughout the body due to covid vaccination; Flare up throughout the body due to winter; Allergic to Enbrel; Asthma flare-up; Sinus infection; Bronchitis; Covid 19 vaccine route of administration: Endocervical; This is a spontaneous report from a contactable healthcare professional, based on the information received by Pfizer from agency (manufacturer control number: US-AMGEN-USASP2020193179), license party for etanercept (ENBREL). This spontaneous report (USASP2020193179) was reported to agency on 25/NOV/2020 by an other health professional and involves a 41-year-old female patient who was allergic to Enbrel [PT: drug hypersensitivity], asthma flare-up [PT: asthma], sinus infection [PT: sinusitis], and bronchitis [PT: bronchitis] while receiving Otezla and Enbrel. No historical medical condition was reported. The patient's current medical condition included psoriatic arthropathy, cough, disease of upper respiratory tract, herpesviral (herpes simplex), irritable bowel syndrome, lupus erythematosus, infection of the skin, migraine, oligomenorrhea, personal history of other diseases of psoriasis, unspecified skin changes and asthma. The patient had allergic to Arava (Leflunomide), cimzia prefl kit (certolizumab pegol), Depo-Medrol (Methylprednisolone Acetate), Humira (Adalimumab), lidocaine, methotrexate, stelara (Ustekinumab), tetracycline, and allergic to Latex gloves and secure glove. The patient's concomitant medications included albuterol [salbutamol], benzonatate, Cymbalta (duloxetine hydrochloride), fexofenadine, multivitamin [vitamins nos], thyroid, and prednisone, Wal Zyr (cetirizine hydrochloride) and amoxicillin and potassium clavulanate. No co-suspect medications were reported. The patient began Otezla on 15/JUN/2016 and Enbrel on an unknown date. On an unknown date, the patient had bronchitis and asthma flare-up that later resulted in a sinus infection. The patient confirmed that she was established on Otezla therapy. On an unknown date, the patient had been allergic to Enbrel. No treatment information was received. The outcome of the events sinusitis, bronchitis, asthma were reported as not recovered. The outcome of the event drug hypersensitivity was reported as unknown. Action taken with Otezla was continued for the events sinusitis, bronchitis and asthma. Action taken with Enbrel was reported as unknown for the event drug hypersensitivity. The other health professional reported that the event drug hypersensitivity was possibly related to Enbrel. The causal relationship between the events sinusitis, bronchitis, asthma, drug hypersensitivity and Otezla was not provided by the other health professional. The causal relationship between the events sinusitis, bronchitis, asthma and Enbrel was not provided by the other health professional. Follow-up has been requested for lot number only. Agency's assessment: the events Drug allergy, Sinus infection, Bronchitis, and Asthma aggravated were assessed as non-serious. Follow-up (22Feb2021):This is a follow up spontaneous report from a contactable consumer, based on information received by Pfizer from agency (manufacturer control number: US-AMGEN-USASP2020193179), license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 22/FEB/2021: In this follow-up information, This serious spontaneous report involves an adult female patient who had flare up throughout the body due to covid vaccination [PT: psoriatic arthropathy], due to winter [PT: sensitivity to weather change] while receiving Otezla, Enbrel. The patient's concomitant medications included azelastine, famotidine, ferrous gluceptate, folic acid, montelukast, and progesterone. The patient's co-suspect medications included Covid 19 vaccine. The patient began Otezla on 15/JUN/2016 and Enbrel on an unknown date. On an unknown date, the patient had flare up throughout the body due to covid vaccination (two round) and also due to winter. The outcome of the events psoriatic arthropathy, sensitivity to weather change was reported as not recovered/not resolved. Action taken with Otezla was continued for the events sensitivity to weather change and psoriatic arthropathy. Action taken with Enbrel was reported as unknown for the events sensitivity to weather change and psoriatic arthropathy. The causal relationship between the events sensitivity to weather change, psoriatic arthropathy and Otezla was not provided by the other health professional. The causal relationship between the events sensitivity to weather change, psoriatic arthropathy and Enbrel was not provided by the other health professional. Agency Comment: This safety report does not necessarily reflect a conclusion by agency that apremilast, etanercept, caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions",Not Reported,,Not Reported,Not Reported,,Not Reported,N,06/15/2016,,,UNK,ALBUTEROL [SALBUTAMOL]; BENZONATATE; CYMBALTA; FEXOFENADINE; MULTIVITAMIN [VITAMINS NOS]; THYROID; PREDNISONE; WAL ZYR; AMOXICILLIN AND POTASSIUM CLAVULANATE; AZELASTINE; FAMOTIDINE; FERROUS GLUCEPTATE; FOLIC ACID; MONTELUKAST; PROGESTERONE,Asthma; Cough; Herpes viral infection NOS ((herpes simplex)); Irritable bowel syndrome; Latex allergy (Latex gloves and secure glove); Lupus erythematosus; Migraine; Oligomenorrhea; Psoriasis (personal history of other diseases of psoriasis); Psoriatic arthropathy; Respiratory tract disorder (Disease of upper respiratory tract); Skin disorder (unspecified skin changes); Skin infection (infection of the skin),,,,"['Asthma', 'Bronchitis', 'Drug hypersensitivity', 'Incorrect route of product administration', 'Psoriatic arthropathy', 'Sensitivity to weather change', 'Sinusitis']",UNK,PFIZER\BIONTECH,OT 1074925,,,M,"stroke; vertigo attack; severe headaches; severe dizziness; A spontaneous report was received from a consumer who was also a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced severe headaches / headache, severe dizziness / dizziness, vertigo attack / vertigo, and stroke / cerebrovascular accident. The patient's medical history was not provided. No relevant concomitant medications were reported. On 13 Feb 2021, prior to the onset of the events, the patient received their second dose of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 13 Feb 2021, about 12 hours after receiving the vaccine, the patient experienced severe dizziness and severe headaches which lasted for about 4 days. On 17 Feb 2021, while driving, the patient thought he was having a vertigo attack and went to the emergency room. He had a cat scan (results not provided) and was treated with TPA (tissue plasminogen activator). After three days in the hospital, they determined he had a stroke. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, severe headaches, severe dizziness, vertigo attack, and stroke, was not provided.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of cerebrovascular accident among others, 5 days after receiving 2nd dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Yes,Yes,,Not Reported,U,02/13/2021,02/13/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse reaction (no adverse reaction reported),,,"['Cerebrovascular accident', 'Dizziness', 'Headache', 'Vertigo']",2,MODERNA,OT 1074926,MN,,F,"sepsis; surgery to put stent in; Blood pressure dropped to 70/20; kidney stone; A spontaneous report was received from a consumer who is an 80-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced sepsis, kidney stone, stent replacement and ended up in ICU and blood pressure dropped to 70/20. The patient's medical history included 6 months of chemo and cataracts surgery in both eyes (not specified). The concomitant product was not provided . On an unknown date prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) in the right arm and patients second dose was scheduled on 25-Feb-2021 for prophylaxis of COVID-19 infection. On an unknown date, after vaccination patient experienced sepsis, put the stent in and ended up in ICU and blood pressure dropped to 70/20/ blood pressure low (18-Jan-2021) and kidney stone. The patient was hospitalized for sepsis, stent replacement and ended up in ICU and blood pressure dropped to 70/20/ blood pressure low. On 04-Mar-2021, she was going to have surgery to have kidney stone which was 9cm long removed and to have stent replaced. Treatment information was not provided. Action taken with respect to mRNA-1273 in response to the events. The outcome of the events was not reported for all events.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. However, the events of kidney stone and stent replacement are unlikely because the kidney stone was preexisting and the procedure of stent replacement was planned for a later date.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/25/2021,,,UNK,,,Medical History/Concurrent Conditions: Chemotherapy (6 months of chemo.); Surgery,,,"['Blood pressure decreased', 'Blood pressure measurement', 'Nephrolithiasis', 'Sepsis', 'Stent placement']",2,MODERNA, 1074927,,,M,"COUGH; oxygenation needs quickly escalated; SHORTNESS OF BREATH; A spontaneous report received from a Healthcare Professional concerning, an 82-year-old male patient who received 2nd dose of the Moderna COVID-19 vaccine and experienced serious adverse events of cough, shortness of breath and hypoxia (reported as oxygenation needs quickly escalated). The patient's medical history included hypertension and hyperlipidemia. Patient's concomitant medications were not included. On unknown date, the patient received their 2nd dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Healthcare Professional stated that Approximately 36 hours after his second vaccination, (on 14-Feb-2021), during a trip with his family, he developed mild cough and SOB that progressed to severe symptoms requiring hospitalization. Healthcare Professional stated patient oxygenation quickly escalated requiring high flow nasal cannula. Patient was initially treated as COVID and high-altitude pulmonary edema. Healthcare Professional stated COVID PCR/ respiratory PCR were negative x 3 and all infectious workup was negative. Healthcare Professional stated the care team began to treat patient with high dose steroids in case of hypersensitivity pneumonitis or eosinophilic lung disease due to vaccination. Patient required a higher level of care but was not stable for transfer home, so the decision was made to transfer patient to ICU where he is currently under the care of ICU and infectious disease specialists. Healthcare Professional stated patient echocardiogram was normal and infectious workup (including COVID and respiratory PCR and cultures) thus far remain negative. Healthcare Professional stated patient is still on high-flow nasal cannula, though skirting intubation. Healthcare Professional feels the process is likely inflammatory versus infectious. Healthcare Professional stated Autoimmune workup is pending. Treatment included high-flow oxygen, solumedrol and empiric antibiotics. Action taken with mRNA-1273 in response to these events was not applicable. The outcome of these events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,,02/14/2021,,UNK,,,Medical History/Concurrent Conditions: Hyperlipidemia; Hypertension,,,"['Cough', 'Dyspnoea', 'Hypoxia']",2,MODERNA,OT 1074928,PA,68.0,F,"Knees were on fire inside, tight, stiff, and can't bend them; Aches; Fatigue; A a spontaneous case report was received from a 68 year old female Other Health Professional concerning herself who received second dose of Moderna COVID-19 Vaccine (m-Rna-1273).. The patients past medical history included double mastectomy and was a cancer survivor. Once the patient took a cancer pill and it made her knees feel like they were on fire. This was 6 years ago. Ongoing conditions of the patient included arthritis and blood pressure. Concomitant medications of the patient included meloxicam, multi vit , atenolol, losartan potassium ,hydrochloroth (hydrochlorothiazide) and potassium chloride. On 15 Jan 2021 the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. The patient took the second dose of vaccine on 12 Feb 2021 into left arm intramuscularly. Five days later on 17 Feb 2021, the patient developed Knee arthritis. The patient also developed aches and fatigue. It hit in the knees and she could barely walk. She had o sit down from room to room. The patient reported the serious criteria to be temporary disability. Patient reported her arm was still black and blue from the first shot when she went for the second one. She had to get both the doses in left arm due to double mastectomy. No treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown. Outcome of the events fatigue and aches was unknown and that of Knees were on fire inside, tight, stiff, and can't bend them was not recovered not resolved. The reporter causality for the events was not provided.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/15/2021,02/17/2021,33.0,UNK,MELOXICAM; ATENOLOL; HYDROCHLOROTH; POTASSIUM CHLORIDE; LOSARTAN POTASSIUM; MULTIVITAMIN [VITAMINS NOS],Arthritis (slight arthritis in the knees); Blood pressure,Medical History/Concurrent Conditions: Mastectomy (cancer survivor cancer and double mastectomy was 6 years ago),,,"['Arthritis', 'Fatigue', 'Myalgia']",1,MODERNA,OT 1074955,OK,82.0,M,"at midnight client got up to go to the bathroom. His legs became weak and he fell and hit his head on the wall. He called for his wife and said he didn't feel right. He denied any pain. She called EMSA and he stopped breathing while she was waiting on them. She gave him CPR with instructions from the dispatcher. He was pronounced dead at 1:30am. She has tried to call the clinic 3 times and left messages and no one has called her back, Her PCP told her this needed to be reported .",Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/14/2021,1.0,MIL,"Metroprolol, zetia, Multag for AFIB, metformin,lisinopril, Immodium, Atorvastatin, was on a blood thinner but stopped 1/25/21","DX with Covid -19 on Jan 2, 2021, had surgery on Jan 28th, 2021 to remove scar tissue between the bladder and prostate.","Afib, diabetes, hypertention, blood clotting disorder",,NKDA,"['Death', 'Fall', 'Feeling abnormal', 'Head injury', 'Muscular weakness', 'Respiratory arrest', 'Resuscitation']",1,MODERNA,IM 1074959,WI,53.0,F,"Janssen COVID-19 Vaccine EUA Injection @ 1130a 1hr after - diarrhea 5hrs after- Rt Arm (opposite arm of shot) tingling sensitive to touch 7hrs after- Skin Crawling painful to touch - low back,thighs, arms, scalp 9hrs after- Freezing and fever sweating 12hrs after- 102 fever, racing BP about 180 high for me, Wrist and Elbows Ached terribly, Lower legs - knee down felt swollen but no sign of swelling. Low back Ached with Pain in Right rear side. Felt like I needed to stretch back and legs tight/anxious. slight Headache 14hrs after- took 2 Tylenol PM & slept restlessly until 8:30 a (12hrs later) 8:30a - Much better with slightly achey back and forearms and occasional headache ting... not constant. Moving slow Had Covid Nov11 2020. Symptoms lasted 6week, each week one symptom would go away and a new would arise- -fever 2days -intensively painful skin crawling 2days -loss of taste and smell -diarrhea (still have loose stools and occasional watery) had diarrhea morning of shot -eyes painfully itchy irritated dry - still occurs most days about 3p -extreme exhaustion in afternoon about 1-3p still",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,WRK,Vitamin C,None,None,,None,"['Anxiety', 'Arthralgia', 'Back pain', 'Blood pressure increased', 'Diarrhoea', 'Feeling cold', 'Formication', 'Headache', 'Hyperhidrosis', 'Mobility decreased', 'Muscle tightness', 'Pain of skin', 'Paraesthesia', 'Poor quality sleep', 'Pyrexia', 'Swelling', 'Tenderness']",1,JANSSEN,SYR 1074982,IL,90.0,F,death,Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,SEN,"amlodipine, Prilosec, Vasotec, Tylenol, coreg, eliquis",,,,penicillin,['Death'],1,MODERNA,IM 1075003,MA,84.0,F,Patient vomited 2 min after receiving vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PUB,No,Tube feedings because patient doesn't eat,Dementia,,Reglan,['Vomiting'],1,JANSSEN,IM 1075017,IL,85.0,F,death,Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,12/30/2020,02/09/2021,41.0,SEN,Toprol omeprazole prednisone,,,,NKA,['Death'],2,MODERNA,IM 1075018,IL,80.0,F,"3/3/21 er to hospital admission: 81 y.o. female with a history of Parkinson's in previous stroke. The patient basically is maintained in the nursing home in this state of being bed-bound and nonverbal. She was recently transferred to Rehab after she developed a stage IV sacral ulcer at a previous nursing home. The patient had been seeing wound care and doing very well. Her stage IV sacral ulcer had been healed to a stage II. She had been gaining weight. Unfortunately, at her wound care appointment yesterday the wound had decompensated a little bit and had started to drain some purulent material. It also enlarged in size a little bit. I was called yesterday afternoon and the nursing home reported the patient was not wanting to eat or drink. Lab work showed a sodium of 170 and creatinine consistent with acute kidney injury. She also appeared to have a urinary tract infection. Because of her critical labs she was sent to the nursing home. The patient was evaluated in the nursing home and then admitted to the floor. She was given Zosyn and vancomycin and started on IV fluids. The emergency room physician did counsel the family that the prognosis was very grim. The patient has done reasonably well overnight. She has been grimacing quite a bit and the family has decided they just want her kept comfortable comfort care during admission",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/20/2021,03/02/2021,41.0,SEN,Lorazepam tylenol,,,,nka,"['Acute kidney injury', 'Aphasia', 'Bedridden', 'Blood creatinine increased', 'Blood sodium increased', 'Decubitus ulcer', 'Diet refusal', 'Grimacing', 'Purulent discharge', 'Urinary tract infection', 'Weight increased']",2,PFIZER\BIONTECH,IM 1075024,,82.0,F,Death,Yes,02/27/2021,Not Reported,Not Reported,,Not Reported,,02/11/2021,02/27/2021,16.0,UNK,,,,,,['Death'],1,PFIZER\BIONTECH,SYR 1075035,,85.0,F,sudden cardiac arrest and death,Yes,03/04/2021,Not Reported,Not Reported,,Not Reported,N,02/23/2021,03/04/2021,9.0,UNK,,,,,,"['Cardiac arrest', 'Death']",2,PFIZER\BIONTECH,IM 1075042,,90.0,F,Patient passed away within 60 days of receiving a COVID vaccine,Yes,03/04/2021,Not Reported,Not Reported,,Not Reported,,01/29/2021,03/04/2021,34.0,SEN,,,,,,['Death'],1,MODERNA, 1075057,IL,91.0,M,death,Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/12/2021,18.0,SEN,"amlodipine Asa 81 ,glipizide Lexapro losartan Prilosec seroquel",,,,NKA,['Death'],2,MODERNA,IM 1075069,KS,74.0,M,On February 22nd the patient had a critically low platelet level of 20,Not Reported,,Yes,Yes,5.0,Not Reported,Y,02/08/2021,02/22/2021,14.0,MIL,Famotidine Simvastatin clopidogrel Lisinopril Aspirin Isosorbide mononitrate,Angina pectoris Coronary artery disease Hypercholesterolemia Hypertension Obesity,Angina pectoris Coronary artery disease Hypercholesterolemia Hypertension Obesity,,No known drug allergies,"['Full blood count', 'Platelet count decreased']",UNK,PFIZER\BIONTECH, 1075074,KY,50.0,F,PATIENT FELT LIGHT HEADED A FEW MINUTES AFTER INJECTION. BLOOD PRESSURE WAS CHECKED AND SHOWN TO BE SLIGHTLY ELEVATED. PATIENT DRANK SOME WATER AND AFTER A FEW MINUTES BLOOD PRESSURE WAS CHECKED AGAIN AND WAS IN NORMAL RANGE.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/05/2021,03/05/2021,0.0,PHM,"LOSARTAN, WELLBUTRIN, ZINC, GABAPENTIN, XYZOL, VITAMIN B-12, VITAMIN D, PROGESTERONE,",MS,MS,,AVALOX IMITREX,"['Blood pressure increased', 'Dizziness']",1,JANSSEN,IM 1075090,IL,96.0,M,death,Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/23/2021,29.0,SEN,Aricept Lexapro lisinopril Toprol vit D Norvasc Seroquel Flomax,,,,,['Death'],2,MODERNA,IM 1075097,NY,87.0,F,"Pt received initial dose on 1/5/21, diagnosed with COVID-19 on 1/8/21, treated with monoclonal antibodies on 1/13/21. Pt experienced CHF exacerbation, anasarca, and renal failure during acute illness. Pt also treated for pneumonia during this time. Pt was considered terminal status on 1/25/21. She received second COVID-19 vaccine on 2/15/21. Pt then experienced increased difficulty eating and taking medications this same day, in addition to hallucinations she was experiencing. Patient subsequently died on 2/16/21.",Yes,02/16/2021,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/16/2021,1.0,SEN,"Tylenol, Hydralazine, Lasix, Miralax, Protonix, senna","Patient received initial vaccine on 1/5/21, diagnosed with COVID-19 on 1/8/21, received monoclonal antibodies on 1/13/21, experienced CHF exacerbation during time of acute illness requiring additional diuretics, patient also experienced renal failure.","Alzheimer's disease, cerebrovascular disease, ASCVD, CAD, PVD, HTN, Afib, CHF, valvular heart disease, abdominal aorta ectasia, hyperlipidemia, COPD, anemia, renal insufficiency, neuropathy, osteoporosis, DDD, scoliosis, diverticulitis, Vitamin D deficiency.",,Bisphosphonates,"['Blood creatinine increased', 'Blood potassium increased', 'Blood urea increased', 'COVID-19', 'Cardiac failure congestive', 'Chest X-ray abnormal', 'Condition aggravated', 'Death', 'Decreased appetite', 'Eating disorder', 'Generalised oedema', 'Glomerular filtration rate decreased', 'Glomerular filtration rate increased', 'Hallucination', 'Oral disorder', 'Pleural effusion', 'Pneumonia', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 1075211,NH,85.0,F,"2/9/2021 Expired at facility. Several weeks prior with several medical and mental health issues as noted prior. 2/4 began with increased lethargy and somnolence. Medications being held per MD. 2/5 CBC WNL, BUN/Cr 38/1.23 GFR 41 2/5 Admitted to Hospice services on 2/5.",Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/09/2021,11.0,SEN,Depakote Sprinkles Capsule Delayed Release Sprinkle 125 MG (Divalproex Sodium) Give 6 capsule by mouth at bedtime related to OTHER SEIZURES (G40.89) *May open capsules* Total dose 750 mg** Depakote Tablet Delayed Release 250 MG (Divalproex,"PNA and treated with Rocephin 1/7-1/14. BUN/Cr elevated and tx with IV fluids. Covid and Influenza negative. D-Dimer elevated. CT scan negative and BLE US negative for clots or pulmonary emboli. Multiple repeat labs. Ongoing overall decline noted in Parkinson's Disease with multiple falls, increased weakness, restlessness, increased confusion, resistive behaviors, paranoid delusions and psychosis. Seen by MD, APRN and Mental Health. 1/12 admitted for palliative services. Seen by APRN Palliative 1/15 with decision per ADPOA for no further IV's or hospitalization. Started Seroquel on 1/21 for increased behaviors and psychosis. Received 2nd Covid Vaccine on 1/29/2021","PARKINSON'S DISEASE DIFFICULTY IN WALKING, NOT ELSEWHERE CLASSIFIED PAIN, UNSPECIFIED ABNORMAL POSTURE MUSCLE WEAKNESS (GENERALIZED HEART FAILURE, UNSPECIFIED OTHER MALAISE COGNITIVE COMMUNICATION DEFICIT DYSARTHRIA AND ANARTHRIA DEMENTIA IN OTH DISEASES CLASSD ELSWHR W BEHAVIORAL DISTURB UNSP PSYCHOSIS NOT DUE TO A SUBSTANCE OR KNOWN PHYSIOL COND OTHER SEIZURES GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS ABSOLUTE GLAUCOMA, BILATERAL OTHER CERVICAL DISC DEGENERATION, UNSP CERVICAL REGION HYPERLIPIDEMIA, UNSPECIFIED IRRITABLE BOWEL SYNDROME WITH CONSTIPATION MAJOR DEPRESSIVE DISORDER, SINGLE EPISODE, UNSPECIFIED INSOMNIA, UNSPECIFIED HYPO-OSMOLALITY AND HYPONATREMIA HYPOTHYROIDISM, UNSPECIFIED ESSENTIAL (PRIMARY) HYPERTENSION ACUTE AND CHRONIC RESPIRATORY FAILURE WITH HYPOXIA",,"Ciprofloxacin, Meperidine, Percogesic","['Blood creatinine normal', 'Blood urea increased', 'Blood urea nitrogen/creatinine ratio increased', 'Death', 'Full blood count normal', 'Glomerular filtration rate decreased', 'Lethargy', 'Somnolence']",2,PFIZER\BIONTECH,IM 1075213,MO,82.0,F,"Muscle and joint pain , chills, and weakness",Not Reported,,Not Reported,Yes,,Not Reported,,03/02/2021,03/03/2021,1.0,PVT,,,,,Celexa and sulfa drugs,"['Arthralgia', 'Asthenia', 'Chills', 'Myalgia']",1,MODERNA,IM 1075220,MD,75.0,M,"Patient presented to ED with black stool and anemia, hemoccult positive, Hgb 6.2. Patient received 1 unit packed blood and IV protonix. Pt admitted. AKI improving on floor. Patient currently still admitted. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,,02/26/2021,03/04/2021,6.0,PVT,,,"hypertension, hyperlipidemia, COPD, CHF, history of subtotal colectomy, legally blind",,"penicillins, ranitidine","['Acute kidney injury', 'Anaemia', 'Faeces discoloured', 'Haemoglobin decreased', 'Occult blood positive', 'Packed red blood cell transfusion']",1,PFIZER\BIONTECH,IM 1075224,NC,44.0,F,"Loss of balance, dizziness, numbing and tingling to left side of tongue, face, gums and left lower lip",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/29/2021,02/10/2021,12.0,MIL,None,Seasonal allergies,GERD,,NKDA,"['Balance disorder', 'Computerised tomogram', 'Dizziness', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Magnetic resonance imaging head', 'Magnetic resonance imaging spinal', 'Paraesthesia', 'Paraesthesia oral', 'Scan with contrast']",1,PFIZER\BIONTECH,IM 1075228,NY,55.0,F,"Cancel her 2nd dose/scheduled for 2nd dose on Feb 27th; Diagnosed for COVID; A spontaneous report was received from a consumer concerning 55-years-old female consumer, who received Moderna's COVID-19 vaccine (mRNA-1273) and was diagnosed for COVID after 27 days of vaccination without any symptoms. The patient's medical history was not provided. No relevant concomitant medications were reported. On 17 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for the prophylaxis of COVID-19 infection. The patient was diagnosed for COVID on 13 Feb 2021. She was exposed on 06 Feb 2021 and had no symptoms. The patient was on a 10 day quarantine and canceled the second dose for 20 Feb 2021. The patient was tested negative for the first rapid test. The first PCR test result was inconclusive and the second PCR test was positive. The patient was scheduled for second dose on 27 Feb 2021, which is an inappropriate schedule of administration (greater than one month apart). Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event COVID-19 infection was unknown and outcome for event inappropriate schedule of product administration was considered as resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273. Based on the current available information and the mechanism of action of mRNA-1273 vaccine, the event of COVID-19, is assessed as unlikely related. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/17/2021,02/13/2021,27.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No patient medical history was reported.),,,"['COVID-19', 'Inappropriate schedule of product administration', 'SARS-CoV-2 test']",1,MODERNA, 1075234,AZ,71.0,M,Massive Heart Attack,Not Reported,,Yes,Yes,4.0,Not Reported,U,02/19/2021,03/03/2021,12.0,PVT,Meloxicam 15mg once morning. Metformin hcl 1000 mg twice daily Valsartan hctz 12.5mg once morning.,,Diabetes High blood pressure,,Latex,"['Coronary artery bypass', 'Laboratory test', 'Myocardial infarction']",1,PFIZER\BIONTECH,SYR 1075236,NM,26.0,M,"could no longer walk and could only crawl, just drags his feet; gets tired very quickly; seemed drunk and his feet from the knee down weren't working; A spontaneous report was received from consumer concerning a 26-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and seemed drunk and his feet from the knee down, he could no longer walk and could only crawl, just drags his feet and was also getting tired very quickly. The patient's medical history included aphasia. Products known to have been used by the patient, within two weeks prior to the event, included diazepam, duwalpro and another, unspecified over-the-counter product. On 15-FEB-2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot unknown) intramuscularly for prophylaxis of COVID-19 infection. That same day, according to report, the patient seemed drunk and his feet from the knee down were not working. On 16-FEB-2021, the patient was unable to walk and could only crawl; he was just dragging his feet. He was also getting tired very quickly. Treatment for the event included paracetamol and ibuprofen. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events was not applicable. The outcome of the events, seemed drunk and his feet from the knee down, he could no longer walk and could only crawl, just drags his feet and was also getting tired very quickly, was considered unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events and the administration of the mRNA-1273 cannot be excluded. Fatigue is consistent with the known safety profile of the vaccine.",Not Reported,,Not Reported,Not Reported,,Yes,U,02/15/2021,02/15/2021,0.0,UNK,DIAZEPAM,,,,,"['Fatigue', 'Gait disturbance', 'Gait inability']",2,MODERNA,OT 1075243,MD,85.0,M,"Patient presented today to ED with palpations, nausea/vomiting, SOB, dry cough. Patient hypoxemic and admitted to the hospital. Patient currently still admitted. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,,03/04/2021,03/05/2021,1.0,PVT,,,"coronary disease with a prior stent 2018, atrial fibrillation, JAK2 mutation polycythemia vera, PEs, DVT, status post IVC filter placement, Hx of GI bleeding, who presents with fever, cough and SOB",,nkda,"['Cough', 'Dyspnoea', 'Hypoxia', 'Nausea', 'Palpitations', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH,IM 1075246,ME,67.0,M,"(3) syncopal episodes following vaccination, one of which resulted in a fall with direct injury to the base of neck, head, and right flank. Pt reported chest pain prior to syncope.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/04/2021,03/04/2021,0.0,PUB,"Tramadol, Diltiazem, Potassium, Magnesium, Protonix, Dorzolamide, Tamsulosin, Atorvastatin, Xarelto, Metoprolol, Oxycontin, Oxycodone, Prazosin",Unknown,"Hepatits C, Anxiety, A-Fib, A-Flutter, Kidney Disease, Diabetes, GERD, Hypotension, Cardiac Stent",,"Januvia, Lyrica","['Chest pain', 'Electrocardiogram normal', 'Fall', 'Flank pain', 'Head injury', 'Hypotension', 'Laboratory test normal', 'Neck injury', 'Renal function test normal', 'Syncope', 'Troponin I normal']",UNK,JANSSEN,IM 1075247,WI,54.0,M,"Deep vein thrombosis left calf; Difficulty breathing; Pulmonary Embolism; Felt doggy, sluggish, punky; Arm hurt; A spontaneous report was received from a nurse concerning a 54-year-old, male patient who experienced pulmonary embolism, deep vein thrombosis, vaccination site pain, sluggishness and dyspnoea. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12-Feb-2021, approximately 2 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient received his vaccine on 12-Feb-2021 and reported that his arm hurt a little for a few days. On 14-Feb2021, he reported that he started feeling sluggish and on 20-Feb-2021 he began to have difficulty breathing and pain in the right lower base of rib cage. He went to urgent care where he was diagnosed with a pulmonary embolism for which he received treatment. On the evening of the same day, he again started having difficulty breathing with pain upon inhalation. He returned to urgent care and was subsequently admitted at 12:30 AM on 21-Feb-2021. That Monday, 22-Feb-2021, a doppler ultrasound revealed a deep vein thrombosis in the left calf. Patient was treated with heparin intravenously (IV). He was discharged 22-Feb-2021. Treatment for the event included Xarelto 20mg twice per day for two weeks and Heparin IV. Action taken with mRNA-1273 in response to the events was not provided/unknown. The outcome of the events, pulmonary embolism, deep vein thrombosis and dyspnea, was considered recovering/resolving as of discharge on 22-Feb-2021. The outcome of the events, vaccination site pain and sluggishness, were considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/12/2021,02/12/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse reaction (No medical history reported.),,,"['Deep vein thrombosis', 'Dyspnoea', 'Pulmonary embolism', 'Sluggishness', 'Ultrasound Doppler', 'Vaccination site pain']",1,MODERNA,OT 1075286,MD,87.0,F,"Patient presents to ER from EMS for SOB and confusion. Of note, patient's husband passed this morning. Troponins elevated. Chest xray shows edema and likely left lower infiltrate. Patient admitted and started on IV antibiotics, Lasix, aspirin, nitroglycerin, and albuterol nebulizers. Patient is currently still admitted.",Not Reported,,Not Reported,Yes,,Not Reported,,03/03/2021,03/04/2021,1.0,PVT,,,"stage III chronic renal insufficiency, non-O2 dependent COPD, hypertension, CAD, hyponatremia, and chronically elevated troponin",,nkda,"['Chest X-ray abnormal', 'Confusional state', 'Dyspnoea', 'Lung infiltration', 'Pulmonary oedema', 'Troponin increased']",2,PFIZER\BIONTECH,IM 1075289,OH,76.0,M,"Patient was vaccinated tihe Pfizer #1 2/12/21. Started feeling weak 2/13 and presented to ED on 2/14. Was admitted to Hospital. Found to be COVID +, required O2 per NC 2-3 L for approx 24 hours. Was found to have NSTEMI. Was transferred for speciality/cardiology care at General Hospital. Was on heparin gtt. Cardiology-no intervention. Was not treated for COVID and was discharged to home on 2/16. Was unable to care for himself at home and was readmitted with in hours. He has failed discharge twice and is being now discharged to SNF",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/12/2021,02/14/2021,2.0,PVT,Anoro 100/62.5/2.5 one puff daily Albuterol med neb QID prn ASA 81mg daily Carvedilol 6.25mg BID Benadryl 25mg QHS prn Furosemide 80mg BID Gabapentin 600mg TID Glimepiride 4mg daily Losartan 100mg daily omeprazole 20mg daily saxagliptin/met,Diagnosed with PNA 1/30/21. Treated with prednisone and Augmentin. Covid test negative at that time but did have a know exposure in his home (grandson tested positive 1/28/21),chronic HFpEF CAD HTN HLD COPD w/asthma type 2 DM morbid obesity chronic LBP w/sciatica BPH,,NKA,"['Acute myocardial infarction', 'Asthenia', 'Blood bicarbonate normal', 'Blood chloride normal', 'Blood creatinine increased', 'Blood glucose normal', 'Blood potassium decreased', 'Blood sodium normal', 'Blood urea increased', 'Brain natriuretic peptide increased', 'COVID-19', 'Chest X-ray abnormal', 'Haematocrit decreased', 'Haemoglobin decreased', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Loss of personal independence in daily activities', 'Lung opacity', 'Platelet count normal', 'SARS-CoV-2 test positive', 'Troponin increased', 'White blood cell count normal']",1,PFIZER\BIONTECH,IM 1075296,OH,69.0,F,Patient was found dead this morning.,Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/02/2021,03/03/2021,1.0,OTH,Do not know,Do not know,"Sleep apnea, blood pressure, obesity Probably other but do not know",,Do not know,['Death'],UNK,MODERNA, 1075298,NY,98.0,F,"Pt had worsening altered mental status, tachypnea, and low-grade fever on 1/13/21. Pt considered terminal status previously and comfort-focus care pursued. Suspected pneumonia vs. TIA/CVA. PO meds D/C'ed as patient could no longer swallow.",Yes,01/17/2021,Not Reported,Not Reported,,Not Reported,N,01/04/2021,01/17/2021,13.0,SEN,"Nystatin powder, Tylenol, Keflex, Eliquis, Lasix, Calcium w/Vitamin D, Omeprazole, Senna, Cymbalta, Remeron, ocusoft lid scrubs, AREDS-2, Vitamin D3","CHF exacerbation in early December with increase in Lasix required. Complaints of malaise and fatigue in early January, treated for UTI with Keflex.","Alzheimer's disease, metastatic melanoma of right neck, Afib, CHF, DMII, anxiety, depression, ARMD, OA, GERD, osteopenia",,"Metoprolol, Paxil, Celexa","['Brain natriuretic peptide increased', 'Cerebrovascular accident', 'Dysphagia', 'Influenza virus test negative', 'Mental status changes', 'Metabolic function test normal', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tachypnoea', 'Transient ischaemic attack', 'Troponin normal', 'White blood cell count increased']",1,PFIZER\BIONTECH,IM 1075308,CA,61.0,F,"still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 went to get covid test but due to blood in my nose received antibody test which was neg; bad headache; winded; vomited; diaherra; coughing/cough; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiry date not reported), via an unspecified route of administration on the left arm on 20Jan2021 18:45 at single dose for COVID-19 immunization. Medical history included diabetes mellitus and high BP from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, losartan potassium and sodium fluoride (CREST CAVITY PROTECTION). The patient previously took septra and experienced allergies. The patient reported that on 21Jan2021, they woke up and brushed their teeth then at 6:40am blood with large clots gushed from their right (rt) nostril. The patient went to ER and stopped bleeding after 2 hrs. On 22Jan2021, the patient woke up with bad headache, winded, vomited, diaherra (as reported), coughing. On 23Jan2021, they went to get covid test but due to blood in their nose, they received antibody test which was negative. On 24Jan2021, the patient was still feeling bad with all the above symptoms. Then on 25Jan2021, they went to ENT doctor who cauterized their nose and stated that since antibody was negative to take the maderna vaccine since they have no antibody in their system, the Pfizer vaccine did not work. From 26Jan2021 to 13Feb2021, the patient felt same started feeling better 14Feb2021 but still have sore muscles in their shoulders and cough. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 23Jan2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of epistaxis and clot blood which include the doctor cauterized their nose. The patient recovered with sequel from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the epistaxis and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including CBC and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/21/2021,1.0,PVT,LEVOTHYROXINE; LOSARTAN POTASSIUM; CREST CAVITY PROTECTION,,Medical History/Concurrent Conditions: Blood pressure high; Diabetes,,,"['Cough', 'Diarrhoea', 'Dyspnoea', 'Epistaxis', 'Feeling abnormal', 'Headache', 'Myalgia', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 antibody test negative', 'Thrombosis', 'Vomiting']",1,PFIZER\BIONTECH, 1075311,MD,77.0,F,"Patient presented to ED with chief complaint of sudden onset dizziness, epigastric pain and generalized weakness, symptoms happened the day before yesterday, resolved, she noticed when she is trying to do any activities she gets heart fluttering. Epigastric pain noted in ED. Troponin Elevated, heparin IV started for possible NSTEMI. Patient is currently admitted.",Not Reported,,Not Reported,Yes,,Not Reported,,02/26/2021,03/04/2021,6.0,PVT,,,"hiatal hernia, hypertension, hyperlipidemia, bronchial asthma, left bundle branch block and aortic stenosis",,nkda,"['Abdominal pain upper', 'Asthenia', 'Cardiac flutter', 'Dizziness', 'Troponin increased']",UNK,PFIZER\BIONTECH,IM 1075313,NC,38.0,F,"miscarried at 12 weeks; received first dose of bnt162b2 on 18Dec2020, second dose on 11Feb2021; received first dose of bnt162b2 on 18Dec2020, second dose on 11Feb2021; This is a spontaneous report from a contactable nurse (Patient). A 38-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248) intramuscular in right arm on 11Feb2021 17:00 at single dose for covid-19 immunisation. No medical history. No COVID prior to vaccination. Other medications in two weeks include prenatal vitamins. Patient received first dose of bnt162b2 (lot number ek5730) on 18Dec2020 12:00 PM intramuscular in right arm. No other vaccine in four weeks. Patient's last menstrual date was 01Nov2020. Patient miscarried at 12 weeks after receiving the second dose of vaccine. Dilation and curettage performed. Outcome was recovered with sequel. Nasal Swab COVID tested negative post vaccination on 18Feb2021.; Sender's Comments: The limited information provided precludes a full clinical assessment of the case. Considering the product-event temporal relationship, a causal association between the reported 'miscarried' and the administration of bnt162b2 cannot be completely excluded. Case will be reassessed once with additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Abortion spontaneous', 'Inappropriate schedule of product administration', 'Off label use', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH,OT 1075318,WI,79.0,F,Patient admitted to hospital pontine stroke following day.,Not Reported,,Yes,Yes,,Yes,U,,02/27/2021,,PHM,,,,,,['Brain stem infarction'],1,PFIZER\BIONTECH,IM 1075322,NJ,68.0,F,"Guillain-Barre syndrome; achy arm; tingling sensation from head to toe/whole body was tingling/weird and scary on and off sensation; This is a spontaneous report from two contactable consumers (patient's cousin and patient herself). A 68-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration in right arm on 10Feb2021 10:30 AM at a single dose for COVID-19 immunisation. Medical history included anxiety. It was reported that the patient was ""physically fit. She was thin and was about 5 feet."" Ongoing concomitant medications included escitalopram (reported as ""generic Lexapro"") for anxiety, calcium, and multivitamins. The patient previously received flu vaccine in Oct2020. She also had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) via an unspecified route of administration in left arm on 20Jan2021 10:30 AM for COVID-19 immunization and felt a little soreness in arm and light headache the same day. Two nights later, her scalp felt on fire and had tingling sensation in her face for three weeks. A week after the first dose, her blood pressure went up to 210/101. She went to the hospital, they controlled her pressure and put her on a pressure pill 1 a day (amlodipine). She mentioned she had felt a weird sensation and noticed some spikes in her blood pressure. Her physician told her to take another 2.5 mg amlodipine if needed. After her second dose, she went to sleep with achy arm. she woke up that night with a tingling sensation from head to toe. Her whole body was tingling. It was a weird and scary on and off sensation. She stated it had improved during the past two days. The patient confirmed that she had no heart rate problems. She actually experienced high blood pressure instead. She never had numbness, instead she had a tingling sensation still present. She mentioned her 97-year-old mother and husband both got the two doses with no complication or reactions. The patient's cousin was ""pretty sure that it's Guillain-Barre."" The patient stated the Guillain-Barre syndrome has not yet been confirmed. She had an appointment with a neurologist. The outcome of 'tingling sensation from head to toe/whole body was tingling/weird and scary on and off sensation' was recovering, of remaining events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/10/2021,0.0,UNK,ESCITALOPRAM; CALCIUM,,Medical History/Concurrent Conditions: Anxiety,,,"['Guillain-Barre syndrome', 'Paraesthesia', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1075349,IL,103.0,F,death,Yes,02/25/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/25/2021,31.0,SEN,Fosamax chlorthalidone losartan clonidine toprol,,,,,['Death'],2,MODERNA,IM 1075354,,93.0,M,Patient passed away within 60 days of receiving a COVID vaccine,Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,,01/07/2021,02/26/2021,50.0,SEN,,,,,,['Death'],1,MODERNA, 1075363,CA,69.0,M,"Death due to Moderna 2nd dose, pulmonary thromboembolism",Yes,02/27/2021,Not Reported,Not Reported,,Not Reported,N,02/25/2021,02/26/2021,1.0,PUB,TBD,,DM Type II,,TBD,"['Autopsy', 'Death', 'Pulmonary embolism']",2,MODERNA, 1075378,KY,35.0,M,"PATIENT RECEIVED VACCINATION AND WAS THEN ASKED TO SIT IN LOBBY. AFTER BEING SEATED PATIENT PASSED OUT AND FELL OUT OF CHAIR, HITTING HIS HEAD AND BITING HIS LIP IN THE PROCESS. 911 WAS CALLED AND EPI PEN WAS RETRIEVED. PATIENT CAME TO AND WAS PALE, SWEATY, AND HAD CLAMMY HANDS. PATIENT REPORTED NO DIFFICULTY IN BREATHING OR FEELING OF THROAT SWELLING SO EPI PEN WAS NOT ADMINISTERED. BP WAS CHECK AND WAS EXTREMELY ELEVATED. AMBULANCE ARRIVED A FEW MOMENTS LATER AND EMTS ASSESSED PATIENT. PATIENTS BP HAD RETURNED TO NORMAL RANGE, COLOR WAS IMPROVED AND HE WAS NO LONGER SWEATING. EMTS ASKED PATIENT IF HE WANTED TO BE TAKEN TO THE ER FOR FURTHER EVALUATION AND PATIENT REFUSED. PATIENT SAT IN THE PHARMACY FOR A FEW MORE MINUTES AND WAS THEN DRIVEN BACK TO WORK.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PHM,"AMOXICILLIN, NORVASC, XYZOL",SINUS INFECTION,HIGH BLOOD PRESSURE,,CECLOR,"['Blood pressure increased', 'Cold sweat', 'Fall', 'Head injury', 'Hyperhidrosis', 'Lip injury', 'Loss of consciousness', 'Pallor']",1,JANSSEN,IM 1075388,IA,81.0,F,"The day after the shot she developed fever for 2 days as high as 101. She developed a pruritic burning rash to posterior right leg extending down the lateral lower leg. She had fatigue and myalgias. Diagnosed with shingles on 2/23. and informed to not receive the 2nd vaccine. She presented to the Emergency room on 2/27 with fatigue, numbness right side of the face, no reports of shortness of breath or chest pain. Ambulated in to ER. After her work up she was discharged home - she present back to the ER within 30 minutes. PTA arrival at the ER for the 2nd time - she complained of left neck and arm pain - then went unconscious. She arrived to the ER in full arrest - pronounced deceased after resuscitation efforts were not effective",Yes,02/27/2021,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/16/2021,1.0,PVT,"Acetaminophen, allopurinol, amlodipine, ezetimibe, furosemide, latanoprost, lisinopril, loratadine, mesalamine, metformin, metoprolol, mometasone, multivitamin, omeprazole,",none,"CLL, Essential hypertension, NIDMM, hyperlipidemia, diverticulosis,",,"Dust, Penicillian","['Blood lactic acid decreased', 'Burning sensation', 'C-reactive protein normal', 'Cardio-respiratory arrest', 'Computerised tomogram head normal', 'Death', 'Fatigue', 'Herpes zoster', 'Hypoaesthesia', 'Loss of consciousness', 'Metabolic function test normal', 'Myalgia', 'Neck pain', 'Pain in extremity', 'Pyrexia', 'Rash pruritic', 'Resuscitation', 'White blood cell count increased']",1,MODERNA,IM 1075407,,64.0,F,Patient passed away within 60 days of receiving the COVID vaccine series,Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,,02/12/2021,03/01/2021,17.0,SEN,,,,,,['Death'],2,PFIZER\BIONTECH, 1075412,NY,94.0,M,Pt with underlying COPD and chronic respiratory failure requiring BIPAP. Pt had cardiopulmonary arrest on 2/24/21 and died as a result. Pt was overall palliative-focused plan of care.,Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,01/26/2021,02/24/2021,29.0,SEN,"Tylenol, Allopurinol, Albuterol inhaler, Combivent inhaler, Symbicort inhaler, metoprolol tartrate, Torsemide, Potassium chloride, Omeprazole, Chlorhexidine rinse",No acute illnesses.,"Alzheimer's disease, ASCVD, valvular heart disease, CHF, HTN, granulomatous disease. OSA, hypoxemic/hypercapnic respiratory failure, GERD, sigmoid diverticulosis, OA, gout",,"Codeine, Penicillin V, aspirin","['Blood chloride decreased', 'Carbon dioxide increased', 'Cardio-respiratory arrest', 'Death']",2,PFIZER\BIONTECH,IM 1075549,ND,71.0,F,Inflammatory polyarthritis with bilateral conjunctivitis,Not Reported,,Not Reported,Yes,10.0,Not Reported,N,02/19/2021,02/23/2021,4.0,PVT,"Aspirin 81, amlodipine 5 mg, hctz 25 mg, pravastatin 10 mg, raloxifene 60 mg, diclofenac-misoprostol",Upper respiratory infection,"Hypertension, GERD, Obesity, OSA, Osteoporosis",,None,"['Anti-cyclic citrullinated peptide antibody negative', 'Antineutrophil cytoplasmic antibody negative', 'Antineutrophil cytoplasmic antibody positive', 'Antinuclear antibody negative', 'Aspiration joint abnormal', 'C-reactive protein increased', 'Complement factor normal', 'Conjunctivitis', 'Culture negative', 'Double stranded DNA antibody', 'Leukocytosis', 'Nucleated red cells', 'Polyarthritis', 'Rheumatoid factor', 'Serum ferritin increased', 'White blood cell count increased']",UNK,MODERNA,IM 1075561,MD,85.0,M,"presents to the emergency department status post mechanical fall this afternoon with a scalp abrasion. Patient states he had surgery performed 6 weeks ago to correct spinal stenosis for L3-L5, and had a recent fall with no LOC. Patient found to have a subdural hematoma. Currently admitted.",Not Reported,,Not Reported,Yes,,Not Reported,,02/17/2021,03/04/2021,15.0,PVT,,,"hyperlipidemia, hypertension, CAD s/p stent and CABG, BPH",,"unasyn, penicillin, procaine","['Fall', 'Skin abrasion', 'Subdural haematoma']",2,MODERNA,IM 1075569,MN,66.0,M,"Patient was being monitored for 30 minutes by EMS due to anaphylaxis to Shrimp. About 15 minutes into monitoring, the patient reported to EMS that he was feeling sweaty and had some shortness of breath. EMS reported BP to be 171/89 and pulse of 88. Patient stated that he does take blood pressure medication and reported that BP was elevated for him. EMS contacted ambulance for transport to Emergency room, patient in agreement to transport.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/05/2021,03/05/2021,0.0,PVT,,,,,,"['Blood pressure increased', 'Dyspnoea', 'Hyperhidrosis']",1,JANSSEN,IM 1075570,ME,30.0,M,"Initially chills and fever. Woke with diffuse, severe myalgia--most severe in quadriceps bilaterally.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/27/2021,02/28/2021,1.0,PVT,Creon 24 Trikafta (elexacaftor/tezacaftor/ivacaftor) CF multivitamin with 5000 units vitamin D Cholecalciferol 2000 units Calcium-vitamin D (250-200 MG-UNIT) Ondasetron (PRN) Albuterol HFA (PRN) Dicyclomine Lidocaine patch (PRN) Ibuprofen,Cystic fibrosis Polymyositis,Cystic fibrosis Polymyositis,,"Ceftazidime--?worsened myositis Orkambi (lumacaftor-ivacaftor)--biopsy proven myositis, felt secondary to lumacaftor","['Blood creatine phosphokinase increased', 'Blood urine present', 'Chills', 'Myalgia', 'Pyrexia', 'Urine analysis']",2,PFIZER\BIONTECH,IM 1075575,MS,50.0,F,"14:59 - RN responded to waiting lot. Pt c/o sensation of facial swelling and heart racing. Denied other complaints. At 1500 BP 110/80, HR 140, R 12. 1503: Pt helt HR slowing down. No further feeling of swelling in face, throat, or elsewhere. 1505: HR 128. 1510: Pt talking, breathing without difficulty. Advised to seek medical attention if s/sx worsen. 3/5/21 @ 1040: Another RN followed up with ph call. Pt reported that after leaving site, she felt HR beginning to speed up. Went to ED and was monitored x 2 hrs. Systolic pressure there was 161. HR was in 140's. No interventions. After 2 hrs VS stabilized and pt was discharged home. Is fine today.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,OTH,Xyzal 5 mg po daily,,"seasonal allergies, BMI >/= 30",,Sulfa (purple rash),"['Blood pressure increased', 'Palpitations', 'Swelling face']",1,JANSSEN,IM 1075578,MD,76.0,F,"Patient presented to ED with altered mental status and leg weakness at home causing fall. Ammonia 89, being treated with lactulose for hepatic encephalopathy. Patient currently admitted.",Not Reported,,Not Reported,Yes,,Not Reported,,02/25/2021,03/04/2021,7.0,PVT,,,"coronary artery disease status post coronary artery bypass graft, bioprosthetic aortic valve replacement, seizure disorder, history of Lyme's disease, colonic AVMs, liver cirrhosis",,"morphine, lisinopril, amlodipine, losartan,","['Ammonia increased', 'Confusional state', 'Fall', 'Hepatic encephalopathy', 'Muscular weakness']",2,MODERNA,IM 1075579,OH,76.0,M,"Shaking, upset stomach, ulcerative colitis flare",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,02/26/2021,02/26/2021,0.0,PHM,"citalopram 40mg, butalb/apap/caff 50/325/40mg, tramadol 50mg, methocarbamol 500mg, clonazepam 1mg, lisinopril 10mg, tamsulosin 0.4mg, pravastatin 20mg, omeprazole 20mg, has had prevnar, fluzone 20/21, and pnuemovax",Joint disorder,ulcerative colitis,,,"['Abdominal discomfort', 'Colitis ulcerative', 'Condition aggravated', 'Tremor']",2,MODERNA,IM 1075597,WI,60.0,M,"Patient had generalized weakness event, similar to MS exacerbation. It lasted approximately 24 hours, rapid recovery after overnight admission to the hospital.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,03/03/2021,03/04/2021,1.0,PVT,Vitamin D3,no acute illness,"Pt has history of Multiple Sclerosis. Was on dalfampridine and Rebiff prior to initial vaccination, but had been holding these. Reaction occurred after second vaccine.",,Sulfa,"['Asthenia', 'C-reactive protein increased', 'Condition aggravated']",2,MODERNA,IM 1075604,MD,82.0,M,Patient presented to ED for on/off SOB the past few days. Required O2 60% FiO2. Acute on chronic CHF exacerbation. Treated with Lasix. Patient is currently improved and planned discharge.,Not Reported,,Not Reported,Yes,,Not Reported,,03/02/2021,03/04/2021,2.0,PVT,,,"Anemia, Atrial fibrillation, BPH (benign prostatic hyperplasia), CAD (coronary artery disease), CHF (congestive heart failure), COPD (chronic obstructive pulmonary disease), COVID-19, Enlarged aorta, Hilar lymphadenopathy, HTN (hypertension), Hyperlipidemia, Pulmonary emphysema, Seizure, and Valvular heart disease.",,cipro,"['Cardiac failure acute', 'Cardiac failure congestive', 'Condition aggravated', 'Dyspnoea']",2,PFIZER\BIONTECH,IM 1075608,NJ,72.0,F,"Patient waited 15 mins after covid vaccination on Wednesday 3/3, cleared by EMT to leave. I was notified by nurse at the senior building where patient resides that she had expired Thursday evening at home. Paramedics were called. No other additional information.",Yes,03/04/2021,Not Reported,Not Reported,,Not Reported,N,03/03/2021,03/04/2021,1.0,PUB,unknown,"Hx of Ca of the breast, last chemotherapy treatment 2/15/21",Breast cancer,,Denies,['Death'],1,MODERNA,IM 1075620,NY,91.0,M,"Patient became acutely ill on 1/15/21 with recurrent pneumonia, treated with Augmentin. Pt became progressively worse on the next 48-72 hours, treatment goals changed to palliative-focused, and all treatments withdrawn. Patient died on 1/22/21.",Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,N,01/05/2021,01/22/2021,17.0,SEN,,None,"Mixed dementia (Alzheimer's and vascular), oropharyngeal dysphagia, ASCVD, CAD, HTN, Afib, CHF, Hyperlipidemia, Depression, anxiety, anemia, ARMD, OA, DDD, Vitamin D deficiency, NPH",,"Tylenol, Eliquis, Ketoconazole cream, Metoprolol, Lasix, senna, voltaren gel, I-vite","['Death', 'Influenza virus test negative', 'Malaise', 'Pneumonia', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 1075635,MN,44.0,F,"VISION DEFICITS IN RIGHT EYE, SUDDEN ONSET",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/10/2021,02/14/2021,4.0,PVT,ZOLOFT,NONE,NONE,,CODEINE,"['Blindness', 'Magnetic resonance imaging']",UNK,MODERNA, 1075636,NH,82.0,F,"1/21/2021 During Covid 19 outbreak on the unit, resident contracted the virus. 1/21 MD updated on increased weakness, twitching, fatigue noted today. 2 rapid covid-19 tests done today, both negative. new orders cbc with diff, BMP, d. dimer stat and swab for covid and Influenza. 1/21-Covid and Influenza swab results received. PCR-Influenza negative, covid-19 positive. Palliative care updated. 1/21-Labs drawn cbc, BMP, d. dimer Results WNL. Temp 101.2 and Occ dry cough. 1/22 Palliative MD and APRN visited. Family preference for no hospitalizations, no IV's and do not intubate. DNR. Admitted to Hospice services on 1/25. 1/21-1/29. Symptomatic with lethergy, occ cough, off and on temp and began refusing meals and meds at times. 1/31 periods of apnea. 2/1 precautions ended for Covid 19. Continued with Hospice care and with ongoing refusal of meals, condition declining and comfort maintained. Meds slowly discontinued. Expired at facility on 2/18/2021.",Yes,02/18/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,01/21/2021,13.0,SEN,cloZAPine Tablet 100 MG;Levothyroxine Sodium Tablet 100;Miralax Powder; Mirtazapine Tablet 15 MG Give 1 tablet by mouth at bedtime; Senokot Tablet;Vitamin D3 Tablet 5000 UNIT Q30D; Clozaril Tablet 50 MG,"Resident on Palliative Care services. Off and on refusals of meds. On Clozaril with monthly CBC. 12/28 WBC low at 3.86, platelets 142. Followed by Mental Health.","1/21/2021 Z86.16 PERSONAL HISTORY OF COVID-19 1/22/2021 I51.7 CARDIOMEGALY 9/10/2020 Z79.899 OTHER LONG TERM (CURRENT) DRUG THERAPY 8/25/2020 F29 UNSP PSYCHOSIS NOT DUE TO A SUBSTANCE OR KNOWN PHYSIOL COND 8/25/2020 F33.9 MAJOR DEPRESSIVE DISORDER, RECURRENT, UNSPECIFIED 8/25/2020 R45.1 RESTLESSNESS AND AGITATION",,Sulfa Antibiotics Tegretol,"['Apnoea', 'Asthenia', 'Body temperature increased', 'COVID-19', 'Cough', 'Death', 'Diet refusal', 'Exposure to SARS-CoV-2', 'Fatigue', 'Fibrin D dimer normal', 'Full blood count normal', 'General physical health deterioration', 'Influenza virus test negative', 'Lethargy', 'Metabolic function test normal', 'Muscle twitching', 'SARS-CoV-2 test negative', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1075639,MD,53.0,M,"Patient is a 53 year old man with a past medical history of follicular lymphoma diagnosed in 2008, more recently with DLBCL with CNS involvement (involving hypothalamus; dx 8/2018; s/p HD MTX, s/p BMT- followed by Dr.), autoimmune hepatitis, obesity, adipic DI, central hypothyroidism and type 2 DM who presented to Hospital via EMS after a fall at home with multisystem organ failure leading to intubation in the ED and subsequent transfer to Oncology ICU for further management. � He was in his usual state if health until Sunday. On Saturday he got COVID vaccine at 4pm, that evening he had no issues. Sunday night around 10pm he didn't make complete sense and his wife was concerned because of his history of DM and treated CNS lymphoma. BG was 320-340 at that time. Monday he was good and Monday night he started to have shaking of his left hand. Tuesday he had one episode of diarrhea. Later he was more shaky in the shower and he started to fall and his wife was unable to grab him and he slid down the wall and could not get up. Family was called to help and he was not making sense so they called EMS. Wife reports that he was down approximately 3 hours before EMS was able to get him up. In EMS he was noted to have a large area of skin desquamation from the right posterior knee to the ankle. His GCS was 15. He had stable blood pressure and heart rate. He was hypoxia to the 50s and oxygen was applied. In the ED he was found to be in multisystem organ failure and was intubated and had rapid progression of shock requiring Epinephrine, Levophed and Vasopressin. Crash lines were placed and he was sent to hospital. Upon arrival he was noted to have a cold pulseless right lower extremity and surgery was called. He was evaluated by Trauma Surgery, Orthopedic surgery and Vascular surgery and eventually underwent above the knee amputation. Unfortunately they were not able to remove all nonviable tissue and he continued to deteriorate. He was taken level 1 back to the OR and an additional 10 cm of nonviable tissue was removed. Unfortunately upon arrive he suffered cardiac arrest in the setting of severe lactic acidosis and hyperkalemia.",Yes,03/04/2021,Not Reported,Yes,2.0,Not Reported,N,02/27/2021,03/01/2021,2.0,PVT,Desmopressin levothyroxine Atorvastatin trulicity once a week,Hypothyroidism Diabetes Morbid obesity Hyperlipidemia Diabetes insipidus,Diffuse large B Cell lymphoma status post allogeneic BMT 5/3/2019,,Citrus Peanuts,"['Blood glucose increased', 'Cardiac arrest', 'Coma scale normal', 'Diarrhoea', 'Endotracheal intubation', 'Fall', 'General physical health deterioration', 'Hyperkalaemia', 'Hypoxia', 'Incoherent', 'Intensive care', 'Lactic acidosis', 'Leg amputation', 'Multiple organ dysfunction syndrome', 'Peripheral coldness', 'Pulse absent', 'Shock', 'Skin exfoliation', 'Surgery', 'Tremor']",1,MODERNA,IM 1075653,MI,34.0,F,"Symptoms of weakness, tired, mild fever and headache starting the day after COVID vaccine. The following day woke up at 6am with chest pain, described as mild to moderate in severity with no radiation. Patient experienced a loss in family member within last 3 months and was under significant stress. Cardiology consult suggested stress may have caused elevated levels of adrenalin and COVID vaccine may have increased catecholamine levels which caused increase in troponins.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/26/2021,02/28/2021,2.0,PUB,"Albuterol Inhaler, Buspar, Voltaren Gel., Wixela Inhaler, OrhtoCyclen, Sumatriptan, Ibuprofen",None,Asthma,,None,"['Asthenia', 'Chest pain', 'Computerised tomogram coronary artery normal', 'Ejection fraction decreased', 'Electrocardiogram', 'Fatigue', 'Headache', 'Prohormone brain natriuretic peptide increased', 'Pyrexia', 'Stress', 'Troponin increased']",2,MODERNA,IM 1075656,MD,73.0,F,Patient presented to ED after waking up dizzy with nausea/vomiting. Mild neck pain. CTA neck showed some stenosis <50% of left internal carotid artery. Patient currently admitted.,Not Reported,,Not Reported,Yes,,Not Reported,,02/12/2021,03/04/2021,20.0,PVT,,,"HTN, HLD, hypothyroidism, calculus of kidney, who presents with Dizziness and nausea",,"erythromycin, penicillins","['Arteriogram carotid abnormal', 'Carotid artery stenosis', 'Dizziness', 'Nausea', 'Neck pain', 'Vomiting']",2,MODERNA,IM 1075657,WI,94.0,F,Resident was having back pain but did have previous back pain prior too.,Yes,03/04/2021,Not Reported,Not Reported,,Not Reported,N,03/01/2021,03/01/2021,0.0,SEN,"Tylenol 650MG BID, Eliquis 2.5MG BID, Furosemide 20MG BID, Morphine 5MG every 2 hours as needed, Potassium Chloride 10 mEq daily, Spironolactone 12.5MG daily, Zolpidem 5MG daily",Currently on Hospice,"Personal history of COVID-19, Acute combined systolic (congestive) and diastolic (congestive) heart failure, Other specified diseases of liver, Acute embolism and thrombosis of unspecified deep veins of right distal lower extremity, Other pulmonary embolism without acute cor pulmonale, Cardiomyopathy, unspecified, Coronary angioplasty status, Essential (primary) hypertension, Hyperlipidemia, unspecified, Age-related osteoporosis without current pathological fracture, Edema, unspecified, Chronic kidney disease, stage 3 (moderate), Anemia, unspecified Note: Acute chronic, Constipation, unspecified, Unspecified fracture of shaft of right fibula, initial encounter for closed fracture, Unspecified sensorineural hearing loss, Syncope and collapse, Collapsed vertebra, not elsewhere classified, thoracic region, initial encounter for fracture, Zoster without complications (History of), Acute respiratory failure with hypoxia, Personal history of transient ischemic attack (TIA), and cerebral infarction without residual deficits, Peripheral vascular disease, unspecified, Cerebrovascular disease, unspecified Nonrheumatic aortic (valve) stenosis Atherosclerotic heart disease of native coronary artery without angina pectoris Nonrheumatic aortic (valve) insufficiency Alzheimer's disease, unspecified",,Penicillin,"['Back pain', 'Condition aggravated', 'Death']",2,MODERNA,IM 1075661,IN,27.0,F,"On Tuesday, 4 days after the vaccine I had a very serious allergic reaction requiring intubation and two day stay in the ICU.",Not Reported,,Yes,Yes,2.0,Not Reported,Y,02/18/2021,02/23/2021,5.0,PVT,"Adderall 30mg XR, 10mg XR & 15mg IR. Birth Control. Lexapro 20mg.",,,,,"['Blood test', 'Endotracheal intubation', 'Hypersensitivity', 'Intensive care', 'X-ray']",1,PFIZER\BIONTECH,SYR 1075706,OH,79.0,M,"patient had to be hospitalized after getting chills, a fever, severe diarrhea and vomiting 3 hours after receiving vaccination. Patient did not report having adverse reactions to previous flue shots at the time of visit, but his wife did report that he has severe reactions to the flu shot each year.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,03/04/2021,03/04/2021,0.0,PHM,,,,,Penicillin Codeine,"['Chills', 'Diarrhoea', 'Pyrexia', 'Vomiting']",UNK,MODERNA, 1075710,NH,96.0,F,"2/6/21 Sent to ER for evaluation of agitation and returned a few hours later on 2/7/21 with no acute findings. 2/7/21 continued with agitation and restlessness and had psychoactive medication changes 2/8/21 Had head CT with no acute findings 2/11/21 MRI of lumbar spine with compression fx T10 2/17/21 UA and KUB done with no acute findings Multiple falls within this time frame with escalating agitation, restlessness, and insomnia. Dx psychosis and started on Seroquel 2/25/21 3/2/21 Patient died",Yes,03/02/2021,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/06/2021,8.0,SEN,"Medications received day of dose 2 vaccination: Lipitor 80mg, imdur ER 30mg, miralax 17grams, remeron 15mg, 2 tablets preservision areds, 2 tablets senna-s 8.6-50mg, Zoloft 25mg, trazodone 50mg, eliquis 2.5mg BID, coreg 12.5mg BID, Lasix 20","11. 12/22/21 Desatted on room air that resolved that day and was back on room air. Chest xray showed cardiomegaly. CBC and BMP no acute findings. No medication changes at that time and patient stabilized. 1/6/21 increased edema to legs and new order increase lasix 20mg PO BID X 3 days 1/11/21 Fell and sent to ER for eval of hip pain. Returned same day no acute findings. 1/15/21 Diagnosed with COVID, had congested cough, chest xray showed cardiomegaly. Had CBC, BMP, d-dimer. 1/20/21 started on mucinex 500mg PO BID for continued congested cough 1/21/21 repeat chest xray, CBC and BMP with no acute findings 1/22/21 CBC and BMP no acute findings 1/25/21 COVID quarantine time completed and considered recovered","12. Hypertension, osteoarthritis, depression, vascular dementia without behavioral disturbance, repeated falls, old myocardial infarction, GERD, acute on chronic diastolic heart failure, atrial fibrillation, exudative age-related macular degeneration bilateral, nonrheumatic aortic valve stenosis with insufficiency, insomnia, allergic rhinitis, hyperlipidemia,",,"Cipro, Pravachol, sudafed, tricor, depodur, ASA(high dose), micardis, adalat, clonidine, tramadol","['Agitation', 'Computerised tomogram head normal', 'Death', 'Fall', 'Insomnia', 'Magnetic resonance imaging spinal abnormal', 'Psychotic disorder', 'Restlessness', 'Spinal compression fracture', 'Urinary system X-ray', 'Urine analysis normal']",2,PFIZER\BIONTECH, 1075721,NC,79.0,M,Patient diagnosed with COVID-19 on 3/2/2021 and patient hospitalized on 3/5/2021. The patient completed the 2 dose Pfizer Covid19 vaccine series on 2/3/2021,Not Reported,,Not Reported,Yes,,Not Reported,N,02/03/2021,03/02/2021,27.0,PVT,"atorvastatin, dexamethasone, Duragesic, gabapentin, lisinopril, ondansetron, oxycodone, prochlorperazine, temazepam, acetaminophen, amlodipine, Lac-Hydrin, hydrochlorothiazide, isosorbide mononitrate, magic mouthwash, tamsulosin","Problem list history: MI, arrhythmia, BPH, cancer, cataract, coronary artery disease, heart disease, hyperlipidemia, HTN, psoriasis, stroke, S/P CABG x 5 2006","MI, arrhythmia, BPH, cancer, cataract, coronary artery disease, heart disease, hyperlipidemia, HTN, psoriasis, stroke, S/P CABG x 5 2006",,metoprolol,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 1075725,WI,99.0,M,Resident started have chest pain on 3/02 and on 03/03 he was lethargic and wasn't eating or drinking Resident was on Hospice,Yes,03/04/2021,Not Reported,Not Reported,,Not Reported,N,03/01/2021,03/02/2021,1.0,SEN,"Bumetanide 2 MG daily, Metoprolol 25 MG daily, Morphine 4 MG daily plus every hour as needed, Nitroglycerin 0.4 MG PRN, Ondansetron 4 MG BID,",,"Anemia, unspecified, Transient cerebral ischemic attack, unspecified, Malignant neoplasm of esophagus, unspecified, Acute pyelonephritis Muscle weakness (generalized) Lack of physical exercise Unspecified systolic (congestive) heart failure Chronic kidney disease, stage 3 (moderate) Atherosclerotic heart disease of native coronary artery without angina pectoris Unspecified osteoarthritis, unspecified site Essential (primary) hypertension Hyperlipidemia, unspecified Vitamin B12 deficiency anemia, unspecified Gastro-esophageal reflux disease without esophagitis Presence of cardiac pacemaker Barrett's esophagus with high grade dysplasia Abdominal aortic aneurysm, without rupture Congenital malformations of other endocrine glands Cerebral infarction, unspecified Idiopathic gout, unspecified site",,Amoxicillin,"['Chest pain', 'Decreased appetite', 'Fluid intake reduced', 'Lethargy']",UNK,MODERNA, 1075755,AR,76.0,M,"Fever, chills, communication difficulties similar to that related to a TIA or stroke",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,03/02/2021,03/03/2021,1.0,PVT,"Metoprolol tartrate 100 mg, clonazePAM 1 mg, aspirin 81 mg, Eliquis 5 mg, amitriptylene 25 mg",None,None,,"Latex, penicillin, shrimp and shellfish, iodine dye, egg base culture injections, poison Ivy, poison oak","['Blood culture', 'Chills', 'Communication disorder', 'Computerised tomogram', 'Culture urine', 'Electrocardiogram', 'Pyrexia', 'Scan with contrast']",UNK,PFIZER\BIONTECH,SYR 1075814,NC,25.0,M,"Janssen COVID-19 Vaccine EUA Beginning morning of 3/4/21. Nausea, extreme fatigue, body ache, severe headache, chills, fever, coughing. Beginning morning of 3/5/21. Nausea, body ache, mild headache, coughing, chills, mild fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/03/2021,03/04/2021,1.0,WRK,Desvenlafaxine Trazadone Buproprion,None,None,,None,"['Chills', 'Cough', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1075844,PR,58.0,M,PRESENT OF FACIAL PARALYSIS ON THE RIGHT SIDE OF THE FACE AFTER THE SECOND DOSE OF THE VACCINE. LOSS OF STRENGTH RIGHT SIDE OF THE FACE FROM EYE TO THE MOUTH. I CAN NOT MOVE THE LIPS AND CLOSED THE RIGHT EYE.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/17/2021,03/03/2021,14.0,PUB,CLONAZEPAM .05MG PANADOL 500MG NORVAC 10MG SINGULAIR 10 MG SIMVASTATIN 20MG METROPOLOL XL 25MG,"HTN, ASTHMA, DEPRESSION","HTN, ASTHMA",,SEAFOOD IODP,"['Eyelid function disorder', 'Facial paralysis', 'Facial paresis', 'Lip disorder']",2,PFIZER\BIONTECH,IM 1075871,TX,89.0,F,"She was vaccinated on 2/2/21 and started feeling bad on 2/4/21. She was treated by her doctor, improved somewhat, got worse, then went to the hospital on 2/16/21. She died on 2/20/21.",Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/04/2021,2.0,PUB,,,,,,"['Death', 'Feeling abnormal']",1,MODERNA, 1075917,HI,93.0,M,WE CALLED PATIENT ON 3/2/21 BECAUSE HE HAD NOT SHOWED UP FOR HIS 2ND DOSE. THE PERSON WHO ANSWERED THE PHONE NOTIFIED US THAT PATIENT PASSED AWAY AT MEDICAL CENTER ON 2/13/21.,Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,,02/09/2021,02/13/2021,4.0,PVT,UNKNOWN,UNKNOWN,UNKNOWN,,NKDA,['Death'],1,PFIZER\BIONTECH,IM 1075922,SC,68.0,M,"Felt bad after vaccine, had arm paint that went up my neck to my head, on 2nd day after shot I collapsed with a stroke. Blood Pressure was sky high. I was taken by Ambulance to Hospital, as I was at work at the time of the stroke. I have perfect bmi, never had high blood pressure, no health problems at all. No heart problems.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/25/2021,02/25/2021,0.0,PUB,"Dexilant 60mg, Xanax .5 mg, Zyrtec,",None,Acid Reflux,,None,"['Cerebrovascular accident', 'Computerised tomogram', 'Echocardiogram', 'Headache', 'Hypertension', 'Magnetic resonance imaging', 'Malaise', 'Neck pain', 'Pain in extremity', 'Syncope']",1,MODERNA,IM 1075958,MD,39.0,F,Dizziness felt like fainting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PUB,,,,,,['Dizziness'],1,JANSSEN,IM 1075966,MO,87.0,F,"Summary - ANAPHYLAXIS. Screened via medical questionnaire with no known hx of anaphylaxis after receiving injection. Less than 10 minutes after receiving injection, pt's son reported to staff that pt was overheated and not feeling well. After receiving ice water, pt became non-responsive to questions and developed tongue swelling, blocked airway and audible wheezing. 0.3mg IM epinephrine injected into L thigh. Pt was laid down in empty exam room. Blood pressure 130/80, pulse 96, temp 96.9. Pt able to sit up, answer questions and breathe comfortably without distress within few minutes of receiving epinephrine. Examined by EMS and declined transportation to ER. Called by physician 4 hours later; pt reported doing well.",Not Reported,,Yes,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PVT,,,"SLE, blindness",,,"['Anaphylactic reaction', 'Feeling hot', 'Malaise', 'Obstructive airways disorder', 'Swollen tongue', 'Unresponsive to stimuli', 'Wheezing']",1,MODERNA,IM 1075996,OR,92.0,M,"Hospitalized February 28, 2021 with acute cerebrovascular accident with left hemiparesis, 4 days after vaccine",Not Reported,,Yes,Yes,4.0,Yes,N,02/24/2021,02/28/2021,4.0,PVT,"levothyroxine, Vitamin D",none,hypothyroid,,none,"['Angiogram cerebral', 'Arteriogram carotid', 'Blood cholesterol normal', 'Blood triglycerides normal', 'Cerebrovascular accident', 'Computerised tomogram head abnormal', 'Echocardiogram normal', 'Hemiparesis', 'High density lipoprotein normal', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Klebsiella test positive', 'Low density lipoprotein normal', 'Polymerase chain reaction', 'Respiratory syncytial virus test negative', 'SARS-CoV-2 test negative', 'Urinary tract infection']",1,MODERNA,IM 1076017,CA,86.0,M,"elderly diabetic man with AFib/RVR who presented with multiorgan failure few hours after receiving his 2nd COVID shot today and ultimately expired. he did well after the 1st COVID shot and subsequently developed this multiorgan failure after the 2nd shot. had his second COVID vaccine shot around 4 pm, went home and collapsed, lay on the floor for a few hours refusing to call paramedics, eventually wife called 911, he arrived to ED and was dead a few hours later. -on arrival the pH was 6.7, agonal breathing, low BP, lactate 18, but no MI, no stroke, no apparent infection/sepsis. important to note that he had a covid vaccine just a few hours from collapsing and dying.",Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/04/2021,0.0,UNK,,,"elderly diabetic man with AFib/RVR who presented with multiorgan failure few hours after receiving his 2nd COVID shot today and ultimately expired. he did well after the 1st COVID shot and subsequently developed this multiorgan failure after the 2nd shot. had his second COVID vaccine shot around 4 pm, went home and collapsed, lay on the floor for a few hours refusing to call paramedics, eventually wife called 911, he arrived to ED and was dead a few hours later. -on arrival the pH was 6.7, agonal breathing, low BP, lactate 18, but no MI, no stroke, no apparent infection/sepsis. important to note that he had a covid vaccine just a few hours from collapsing and dying.",,,"['Agonal respiration', 'Alanine aminotransferase increased', 'Anion gap increased', 'Aspartate aminotransferase increased', 'Bilirubin conjugated increased', 'Blood albumin decreased', 'Blood alkaline phosphatase increased', 'Blood bicarbonate decreased', 'Blood bilirubin increased', 'Blood calcium decreased', 'Blood chloride normal', 'Blood creatine phosphokinase increased', 'Blood creatinine increased', 'Blood glucose decreased', 'Blood magnesium normal', 'Blood pH decreased', 'Blood potassium increased', 'Blood sodium normal', 'Blood urea increased', 'Carbon dioxide decreased', 'Death', 'Glomerular filtration rate decreased', 'Hypotension', 'Lipase increased', 'Multiple organ dysfunction syndrome', 'Protein total decreased', 'Syncope', 'Troponin I increased']",2,PFIZER\BIONTECH, 1076091,OH,68.0,F,"15 minutes after injection, customer complained about metallic taste, tongue slightly swollen with small bubbles on each side of tongue. No difficulty in breathing. We asked to stay 15 minutes more for observation. Had tightness in the chest 5 minutes later. Called 911. Operator asks not to give water/benadryl/epipen. EMT arrived 5 minutes later and assessed. Watch 15-20 minutes later walked her out to car. We checked 6:45 pm still have metallic taste and just little swollen on tongue. Called 3/5/21 @ 2:30pm no more symptoms., only from the JNJ shot. tiredness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,PHM,"letrozole, prolia, multivitamin , and vitamin D, calcium,",none,cancer in past history,,"shell fish, penicillin","['Chest discomfort', 'Dysgeusia', 'Fatigue', 'Swollen tongue', 'Tongue blistering']",1,JANSSEN,IM 1076108,MO,77.0,M,"Patient received first dose of vaccine on 2/8/2021. Was monitored properly with no adverse reaction, but had a stroke a few hours later after leaving facility. Patient is still hospitalized.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/08/2021,02/08/2021,0.0,UNK,,,,,,['Cerebrovascular accident'],1,MODERNA,IM 1076118,OH,62.0,M,Fast heart rate. Thought it was going to shock me from defibrillator.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/05/2021,03/05/2021,0.0,UNK,Carvedilol 25mg Spironolactone 25mg Eliquis 5mg Entresto 49/51 Magnesium 400 m Vitamin D-3 5000 IU Multivitamin,,Myocardial Tachycardia Arrhythmia,,,['Heart rate increased'],1,JANSSEN,SYR 1076119,NY,72.0,M,At some point after the 2nd vaccine the patient had increased weakness and shortness of breath. He presented to the ER and was noted to have acute kidney injury. Patient was admitted from 2/23- 2/27.,Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,02/21/2021,02/21/2021,0.0,PVT,"Eliquis, Flexeril, Lipitor, Pentoxifylline ER, Protonix, Citalopram, Flomax, Methadone, Oxycodone HCL ER, EC ASA, Magnesium Oxide, Biotin vitamin, Vit D 3, Breo Ellipta 200/25, Advair diskus","states he has been having ""heart trouble"" and anemia for a few months.","COPD, A Fib, HTN, Hyperlipidemia, Pacemaker (AICD), LBBB, Bleeding ulcers, Right kidney has many small tumors, chronic back problems (ankylosis; spondylitis), anemia, cellulitis of lower legs, B Cell lymphoma, residual calcified mesenteric mass - s/p chemo and radiation- in remission per patient.",,"IV Contrast dye, Sulfa meds","['Acute kidney injury', 'Asthenia', 'Blood creatinine increased', 'Blood urea increased', 'Dyspnoea', 'Glomerular filtration rate decreased']",2,PFIZER\BIONTECH,IM 1076122,CA,54.0,M,"At 5 days post vaccination, patient developed severe left shoulder pain, originally thought to be secondary to chronic shoulder pain and a recent fall, over the next three days it progressed to swelling, severe pain, and limited ROM. He ended up being admitted to the hospital and CT scan showed development of significant soft tissue infiltration around sternum and sternoclavicular joints. This was originally thought to be infectious, but he never developed a fever or leukocytosis and we feel this was most likely an inflammatory process. I have no idea if this was actually a vaccine side effect, but given the proximity in both time a location and the known complication of shoulder pain with the vaccine, it seems reasonable to give you the information to monitor for other similar cases.",Not Reported,,Not Reported,Yes,8.0,Not Reported,Y,02/06/2021,02/11/2021,5.0,PVT,"Pregabalin, buspirone, baclofen, trazodone, tums, vitamin D, hydrocodone/apap 10mg daily","Osteoporosis, compression fractures, generalized anxiety disorder",Same as above,,NKDA,"['Blood culture negative', 'Blood lactic acid normal', 'C-reactive protein increased', 'Computerised tomogram thorax abnormal', 'Inflammation', 'Injected limb mobility decreased', 'Injection site pain', 'Injection site swelling', 'Tissue infiltration', 'White blood cell count increased']",1,MODERNA,IM 1076130,KS,63.0,F,"Started having loss of hearing in my L ear, made appt with ENT doctor who gave me a steroid injection in ear as well as prescribing steroids to take by mouth. After 2 weeks my hearing is much worse and ENT doctor is certain this is due to Covid #2 shot.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/12/2021,02/15/2021,3.0,PVT,tylenol,nothing,,,"sulfa, amoxicillan","['Audiogram', 'Deafness unilateral', 'Magnetic resonance imaging']",UNK,MODERNA,IM 1076153,TX,43.0,F,"Received vaccine on 3/3/21 at 2:30pm. Waited for 20 minutes at pharmacy for allergic reaction. Given the all clear, so headed home. Around 5pm, I started noticing how extremely sore my left arm was, almost as if somebody had hit it with a baseball bat (no bruising, redness, etc., just VERY sore). I also started noticing numbness and tingling in my left arm that traveled down the outside of my arm into my left hand and into my left pinky finger. As the evening progressed, I lost my appetite, developed a headache, felt extremely fatigued, was dizzy, had muscle and joint aches, had left kidney pain, and began to feel flushed and hot. I took my temperature and it showed I was running a low-grade fever of 98.7F (my normal temperature is anywhere between 96.9F and 97.1F). I went to bed around 9pm. Around 3am (which is now 3/4/21), I woke up with nausea, and my left arm/hand/finger really experiencing numbness and tingling (it's as if that portion of my arm/hand/finger was semi-paralyzed). I went to the bathroom and was on the verge of throwing up. I broke out into a cold, clammy sweat but did not vomit. I got back into bed and went back to sleep. Around 5am (still 3/4/21), I woke up again with nausea and my left arm/hand/finger still numb and tingling (semi-paralyzed). I went to the bathroom and was again on the verge of throwing up. I, again, broke out into a cold, clammy sweat but did not vomit. I got back into bed. I decided to take a Zofran around 6am for the nausea. I slept from 8am-12pm on 3/4/21 due to the Zofran. When I woke up, I called the pharmacist at pharmacy to notify them of my symptoms. The pharmacist everything I experienced was normal and should go away in 2-3 days (if they didn't then contact my regular doctor), that I could take Tylenol for any pain, and I still needed to keep my follow-up appointment for the second shot. The entire day on 3/4/21 from 12pm until I went to bed around 10pm, I still experienced an extremely sore arm, loss of appetite, slight headache, fatigue, dizziness, muscle and joint aches, left kidney pain, low-grade fever (for me), and the numbness/tingling/paralysis in my left hand and left pinky finger. I was able to sleep through the night, and woke up around 6am on 3/5/21. Currently, I am still experiencing an extremely sore arm, fatigue, and the numbness/tingling/paralysis in my left hand and left pinky finger. I am EXTREMELY concerned about the numbness/tingling/paralysis in my left hand and left pinky finger as it does not seem to be getting better.",Not Reported,,Not Reported,Not Reported,,Yes,N,03/03/2021,03/03/2021,0.0,PHM,"Daily vitamin, Vitamin C, Vitamin D, Folic acid, Probiotic, Cetirizine, CBD capsule, Fiber, Herbal supplements","Sinusitis, Allergic Rhinitis","Sinusitis, Allergic Rhinitis, IBS/IBD, Anxiety, Depression",,"Sulfa, Penicillin, Ceclor, Amitriptyline, Phenergan, Latex","['Arthralgia', 'Cold sweat', 'Decreased appetite', 'Dizziness', 'Fatigue', 'Headache', 'Hot flush', 'Hypoaesthesia', 'Myalgia', 'Nausea', 'Pain in extremity', 'Paraesthesia', 'Pyrexia', 'Renal pain', 'Sleep disorder']",1,MODERNA,IM 1076158,PA,69.0,M,Patient was found dead at his home on 2/25/2021. He was last seen at home by his sister at 8:30pm on 2/24/21.,Yes,02/25/2021,Not Reported,Not Reported,,Not Reported,N,02/24/2021,02/24/2021,0.0,PVT,"albuterol, Anoro Ellipta, donepezil, gabapentin, Intellence, losartan, meotprolol, mybertiq, rouvastatin, synmtuza, tamsulosin,",none,"systolic heart failure, HIV, HTN, DM2, history of prostate cancer, COPD,",,NKDA,['Death'],UNK,MODERNA,IM 1076162,MO,81.0,M,"Patient received vaccine on 1/11/2021. Patient passed away 1/15/2021, cause not reported, unaware if related.",Yes,01/15/2021,Not Reported,Not Reported,,Not Reported,,01/11/2021,01/15/2021,4.0,UNK,,,,,,['Death'],1,MODERNA,IM 1076188,NC,65.0,M,"Out of hospital cardiac arrest and refractory shock, acute kidney injury, shock liver, respiratory failure leading to death",Yes,02/21/2021,Not Reported,Yes,1.0,Not Reported,N,02/20/2021,02/20/2021,0.0,PVT,"Entresto, Coumadin, Carvedilol, Spironolactone, Lanoxin, Calcium, Probiotics","Mild kidney impairment, mild hyperkalemia","Mitral valve prolapse, congestive heart failure, atrial fibrillation",,None,"['Acute kidney injury', 'Cardiac arrest', 'Death', 'Ischaemic hepatitis', 'Respiratory failure', 'Shock']",1,PFIZER\BIONTECH,IM 1076191,OH,65.0,M,"Patient woke up on 2/28/21 extremely fatigued. Fatigue continued through 3/1/21. On 3/2/21 patient woke up in the morning with shortness of breath, wheezing, headache, joint pain, muscle pain, and a fever of 104. He was admitted to the hospital on this day. He left hospital on that same day against physician's orders. He talked to his primary care doctor on 3/3/21 and she told him to return to hospital, which he did. Patient stated he still had same symptoms as on 3/2/21. After patient's fever was resolved in the hospital he left again against physician's orders. Patient stated most of his symptoms resolved on 3/3/21 except for some muscle pain and shortness of breath. Patient followed up with his primary care provider, on 3/5/21 and said he is feeling better other than being a little short of breath.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/20/2021,02/28/2021,8.0,PHM,metoprolol er 100 mg 1&1/2 tablets daily losartan 100 mg once a day amlodipine 10 mg once a day escitalopram 20 mg once a day tradozone 50 mg once a day alprazolam 0.5 mg up to 3 times a day as needed,none known,"high blood pressure, anxiety, depression, arthritis",,none known,"['Arthralgia', 'Dyspnoea', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia', 'Wheezing']",1,MODERNA,IM 1076282,IA,49.0,F,"Client stated her lips felt tingly and her throat felt itchy. Airway clear, respirations even and unlabored, heart rate within normal limit. Patient in no acute distress. No angioedema noted. Patient was administed Benadryl 25mg PO X 1 dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,WRK,,,,,,"['Paraesthesia oral', 'Throat irritation']",1,JANSSEN,IM 1076291,TN,46.0,M,"Had a seizure while watching TV with my family. I was setting in a chair, not stressed. Family called 911 and ambulance came to take me to office",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/09/2021,02/10/2021,1.0,PVT,None worth mentioning,None,None,,None,['Seizure'],2,MODERNA,IM 1076306,MA,65.0,M,"65m received J&J vaccine, 10 minutes after admit c/o a gripping pain mid sternum, a 2 on scale of 1-10. Pt brought ot observation area, pain non changing after 15 minutes, eval'd by on site EMS. Transferred to ED for eval. Pt notified his daughter prior to leaving vaccine clinic. He had no complaints of other symptoms. Per electronic health records, pt drove himself to ED.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/04/2021,03/04/2021,0.0,UNK,,,,,"latex = rash, gluten=unspecified, bupropion=dysphoria,",['Chest pain'],1,JANSSEN,IM 1076316,OH,40.0,F,"Pt feels dizzy, hot, headache. VS BP 122/80, HR 75, RR 18, Osat 98% Left arm numb from elbow down.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PUB,"Adderall, Orilissa,",None,"Migraine, Endometriosis",,"Cipro, Betadine","['Dizziness', 'Feeling hot', 'Headache', 'Hypoaesthesia']",UNK,JANSSEN,IM 1076318,IN,62.0,M,blood pressue 96/42. patient sweating. feeling dizzie like he was about to pass out. provided food/water and constant monitoring until symptoms resolved,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PHM,hctz 25mg 1qd,none,high blood pressure,,none,"['Blood pressure decreased', 'Dizziness', 'Hyperhidrosis']",1,JANSSEN,IM 1076322,CA,74.0,M,Rectal bleed,Not Reported,,Not Reported,Yes,,Not Reported,Y,02/26/2021,03/01/2021,3.0,OTH,"Leflunomide 20 mg, Hydroxychloroquine 200 mg, Rosuvastatin calcium 10 mg, Losartan Potassium 100mg",None,Rheumatoid Arthritis,,None,['Rectal haemorrhage'],UNK,MODERNA, 1076717,,,F,"Thrombocytopenia (diffuse petechiae, easy bruising, bleeding gums); Polychromasia; Petechiae; Easy bruising; Mild headache; Anisocytosis; A spontaneous report was received from a literature article concerning a 36, year old, female patient who experienced thrombocytopenia, headache, polychromasia, anisocytosis, petechiae and easy bruising. The patient's medical history included thrombocytopenia and allergy to acetaminophen. Products known to have been used by the patient, within one week prior to the event, included ibuprofen and sumatriptan. A vaginal ring containing etonogestrel-ethinyl estradiol, was place one week prior to hospitalization Approximately one week prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on unknown date, intramuscularly in the for prophylaxis of COVID-19 infection. The patient presented to the hospital on unknown date with diffuse petechiae, easy bruising, bleeding gums and mild headache. Vital signs were within normal limits upon arrival at hospital. Physical exam was notable for diffuse petechiae of the extremities and trunk along with oral ecchymosis of 1-2 cm: no focal neurological deficits were observed, and no hepatic or splenic enlargement was noted. Blood work was significant for white blood count of 13.1 L/uL, hemoglobin 13.6 g/dL, heamatocrit of 42.1%, and platelet count of 3000/uL. Prothrombin time and activated partial thromboplastin time were within normal limits. SARS-CoV2 swab was negative but the SARS-CoV2 IgG antibodies were reactive. Peripheral smear showed thrombocytopenia without clumping along with polychromasia and anisocytosis appreciated with some mature neutrophils. A CT scan of the head did not show acute infarction or hemorrhage. Treatment for the event included, dexamethasone 40 mg intravenously daily for four days, intravenous immunoglobulin (IVIG) 1 mg/Kg for three days and was place on the Health Stroke Scale monitoring. Platelet count improved to 28000/uL within 3 days and oral lesions disappeared through some petechiae remained. The patient's contraception ring was not removed. The patient was discharged with outpatient hematology follow up. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the event(s) was not reported. According to the abstract, the temporal sequence of the events suggests an exacerbation of the patient's chronic thrombocytopenia related to the receipt of the mRNA-1273 Covid-19 vaccine. The abstract also stated that it is possible based on reviews of reported side effects unlikely, that the patient's headache medications and contraception were triggers for this event. Follow up: No follow up provided.; Reporter's Comments: Very limited information regarding the events has been provided at this time.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,etonogestrel-ethinyl estradiol,,Medical History/Concurrent Conditions: Allergy (Allergic to acetaminophen); Immune thrombocytopenia; Procedural bleeding (excessive bleeding after dental procedures),,,"['Activated partial thromboplastin time normal', 'Anisocytosis', 'Computerised tomogram', 'Contusion', 'Haematocrit', 'Haemoglobin', 'Headache', 'Petechiae', 'Platelet count', 'Polychromasia', 'Prothrombin level', 'Prothrombin time', 'Thrombocytopenia', 'White blood cell count increased']",1,MODERNA,OT 1076718,NY,69.0,F,"unable to stay standing without falling; getting anxiety ridden; tried to get out of bed and fell; couldn't talk; memory started to go; tremor in right, dominant hand; feeling sick; A spontaneous report was received from a consumer regarding a 69-year-old, female patient who received the Moderna COVID-19 Vaccine (mRNA-1273) and experienced tremors in right, dominant hand/tremor, trouble standing but was not falling down/balance disorder, feeling sick/malaise, tried to get out of bed and fell/fall, memory started to go/memory impairment, couldn't talk/aphasia, and getting anxiety ridden/anxiety. The patient's medical history included Lyme Disease, severe back problems, high cholesterol, acid reflux, sleep disturbances and nerve pain. Concomitant products known to have been used by the patient, within two weeks prior to the event, included Hydroxychloroquine, Clarithromycin, Amoxicillin, Doxycycline, Lipitor 80 mg, Oxycodone 45 mg four times daily, Trazodone, Ambien, Pepcid, Lyrica, Pantoprazole 40 mg, Cyclobenzaprine, Valium 5 mg, Klonopin 0.5 mg. On 12FEB2021, the patient received the second of two planned doses of mRNA-1273 (BATCH: 013L2DA) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 23FEB2021, the patient reported the following events after receiving the first dose of Moderna COVID-19 (mRNA 1273) Vaccine: ""The patient reported that on 15Jan2021, she received her first dose of the Moderna COVID-19 Vaccine in her left non-dominant arm, at her local Department of Health. Within days after receiving her first dose, she experienced tremor in her right, dominant hand. The patient reported that her hand was shaking, and she was dropping things, spilling and had trouble standing but was not falling down. The patient reported that prior to receiving her first dose of the Moderna COVID-19 Vaccine, she had been taking Hydroxychloroquine and Clarithromycin to treat Lyme Disease. She had been on these two medications for a couple of weeks. The patient thought that the tremors might have been due to the Hydroxychloroquine and because she was also feeling sick, she stopped taking the Hydroxychloroquine, but continued taking the Clarithromycin. The tremors continued. Her doctor advised her to resume taking the Hydroxychloroquine, starting with � pill, then � pill working her way up in dosing. The patient reported that her hand tremors never stopped"". On 23FEB2021, the patient reported the following events after receiving the second dose of Moderna COVID-19 (mRNA 1273) Vaccine: ""On Friday, 12Feb2021, the patient received her second dose of the Moderna COVID-19 Vaccine in her dominant arm, at the same facility. By Monday, 15Feb2021 and Tuesday,16Feb2021, after receiving the second dose, the patient's tremors increased. She reported that she ""got much worsening shaking in hand"". She was ""unable to stay standing without falling"". She also stated that her ""memory started to go"" and she started dropping things such as glasses of juice, spilling things and her memory was getting worse. On Thursday, 18Feb2021, the patient reported it started getting so bad, ""tried to get out of bed and fell"". She stated that she tried to hold on to something but her body would twist and she wound up on the floor. On Friday, 19Feb2021 her husband called Emergency Medical Services (EMS) and had her taken to the hospital. She stated that she couldn't remember what day it was, who was the President, her date of birth or a lot of things. She stated that she was going blank and could not stand up without assistance. She said that she couldn't talk and it was very scary. She was admitted to the hospital on the following day, Saturday, 20Feb2021. She states that she was ""getting anxiety ridden"" and her ""whole body just shakes"". The patient stated that they ran a battery of tests and she was discharged the next day, on Sunday, 21Feb2021, because as she stated ""they couldn't find anything"". The patient informed the hospital that she had had the 2nd Moderna COVID-19 Vaccine. She was told that her symptoms had nothing to do with the vaccine, but she disagrees"". The action taken for Moderna COVID-19 Vaccine was reported hospitalization. The outcome of the events was reported as recovering.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/15/2021,01/01/2021,,UNK,PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; CLARITHROMYCIN; LIPITOR; Oxycontin (oxycodone hydrochloride) extended release; LYRICA; AMOXICILLIN; DOXYCYCLINE; TRAZODONE; AMBIEN; PEPCID DUO; PANTOPRAZOLE 40; CYCLOBENZAPRINE; VALIUM; KLONOPIN,"Acid reflux (oesophageal) (Pepcid for acid reflux, Pantoprazole 40 mg for acid reflux); Back disorder NOS (bad back since 1997 and takes painkillers such as Oxycodone 45 mg, four times a day); High cholesterol",Medical History/Concurrent Conditions: Lyme disease (She is presently taking the Clarithromycin along with the Hydroxychloroquine for Lyme Disease.); Lyme disease; Nerve pain (Lyrica for nerve pain),,,"['Anxiety', 'Aphasia', 'Balance disorder', 'Fall', 'Malaise', 'Memory impairment', 'Tremor']",2,MODERNA,OT 1076719,PA,43.0,M,"Fever up to 100.9 F; Sinus pressure; Body aches; Tiredness; Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in the left arm on 27Jan2021 at 16:30 at the age of 43 years old at a single dose for COVID-19 Immunization at health clinic/ administration facility. The patient's medical history included mild asthma, CT contrast agent allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) at the age of 43 years old on 07Jan2021 at 12:30 pm in the left arm for COVID-19 Immunization. The patient's concomitant medication included montelukast, albuterol (Salbutamol) and beclomethasone. The patient experienced fever up to 100.9 F, sinus pressure, body aches, tiredness, pain at injection site on 28Jan2021 at 6:00 AM. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/28/2021,1.0,PUB,MONTELUKAST; ALBUTEROL [SALBUTAMOL]; BECLOMETHASONE [BECLOMETASONE],,Medical History/Concurrent Conditions: Asthma; Contrast media allergy,,,"['Body temperature', 'Fatigue', 'Pain', 'Paranasal sinus discomfort', 'Pyrexia', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1076720,NY,31.0,F,"early, heavy period; early, heavy period; This is a spontaneous report from a contactable other health care professional (patient). A 31-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EV0142, expiry date was not provided) via Intramuscular route, at Left arm, on 06Jan2021 17:30 as single dose for COVID-19 immunization, at hospital. Patient's medical history included congenital adrenal hyperplasia, late, light periods and COVID-19 (Prior to vaccination, patient was diagnosed with COVID-19). Concomitant medications included methylprednisolone, colecalciferol (VITAMIN D) and cetirizine hydrochloride (ZYRTEC); all these medications received within 2 weeks of vaccination. Patient had no Allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. It was reported that, Prompted an early, heavy period on 11Jan2021. No none other stressors. Patient had history of late, light periods. This one came 2 weeks early and was significantly heavier than usual. Facility the most recent COVID-19 vaccine was administered to hospital. No treatment was received for these events. Seriousness of the events was reported as non-serious. Outcome of the events was recovered in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,01/11/2021,5.0,PVT,METHYLPREDNISOLONE; VITAMIN D [COLECALCIFEROL]; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,"Medical History/Concurrent Conditions: Congenital adrenal hyperplasia; COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?:Yes); Late period; Light periods",,,"['Heavy menstrual bleeding', 'Menstruation irregular']",1,PFIZER\BIONTECH,OT 1076721,MN,73.0,M,"site sore; tiredness; headache; chills; nausea; feeling unwell; dizziness; weakness; This is a spontaneous report from a contactable consumer (reporting for himself). A 73-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiration date: unknown), via an unspecified route of administration in his left arm from an unspecified date at single dose for covid-19 immunization. The patient's medical history included post-traumatic stress disorder (PTSD). Concomitant medications were not reported. The patient previously took codeine and sertraline and experienced allergy. On 22Jan2021 at 16:00, the patient experienced site sore, tiredness, headache, chills, nausea, generally feeling unwell, dizziness and weakness. The outcome of the events was recovered on an unspecified date. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/22/2021,,PUB,,,Medical History/Concurrent Conditions: Post-traumatic stress disorder,,,"['Asthenia', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Malaise', 'Nausea']",1,PFIZER\BIONTECH, 1076722,,,U,"severe shoulder pain; shoulder injury related to vaccine administration; limited range of motion; limitations with activity of daily living; This is a spontaneous report received from a contactable Pharmacist via Medical Information Team. A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot/Batch number: Unknown), on an unspecified date via an unspecified route of administration at single dose for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient had concern about shoulder injury related to vaccine administration. On an unknown date the patient had severe shoulder pain, limited range of motion, and limitations with activity of daily living. The outcome of the events was reported as unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Arthralgia', 'Loss of personal independence in daily activities', 'Shoulder injury related to vaccine administration', 'Vaccination site movement impairment']",2,PFIZER\BIONTECH, 1076723,NY,69.0,F,"Woke up the following day (1/29/2021) with extreme vertigo. I have a history of vertigo, last episode 4 or 5 years ago. This episode lasted 5 hours; Exhaustion and slept for 4 hours; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EZ9264), via an unspecified route of administration on right arm on 28Jan2021 at 15:45 at the age of 69 year old at a single dose for COVID-19 immunisation at the hospital. Medical history included coronary artery disease, vertigo (I have a history of vertigo, last episode 4 or 5 years ago). Allergies to medications, food, or other products was dilantin, streptokinase. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Concomitant medications were not reported. The patient previously took dilantin, streptokinase and experienced allergies. It was reported that patient woke up the following day (29Jan2021, 09:00 AM) with extreme vertigo. This episode lasted 5 hours. Following that, about an hour after she arose, she had exhaustion and slept for 4 hours. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the event vertigo aggravated on 29Jan2021 14:00 and recovered from exhaustion on an unspecified date in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/29/2021,1.0,PVT,,,"Medical History/Concurrent Conditions: Coronary artery disease; Vertigo (I have a history of vertigo, last episode 4 or 5 years ago.)",,,"['Fatigue', 'Vertigo']",1,PFIZER\BIONTECH, 1076724,MA,72.0,F,"Headache; profound fatigue/tired; not feeling well; sick; This is a spontaneous report from a contactable consumer. A 72-Year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID VACCINE, lot number unknown, expiration date unknown), via intramuscular on the left upper arm, on 21Jan2021 at 16:30 at the age of 72 years old at a single dose for COVID-19 immunisation at senior residence. The patient medical history was none. Concomitant medications were not reported. The patient previously took Shingrix for shingles vaccine (immunisation) and both times she took it she was in bed for 3 days and then she was fine. Patient was calling about the Pfizer BioNtech covid vaccine. Since she had the vaccine and this is the 8th day since she had it. On 21Jan2021, patient had a headache and profound fatigue, she was not feeling well since she got the vaccine. She was still sick on an unspecified date in 2021. Her headache started about 30 minute s after getting the vaccine. That same night she felt really tired and when she woke up she was really fatigued. The patient occasionally takes Advil as treatment. The patient did not visit emergency room and physician office. No additional vaccines administered on same date of the Pfizer suspect. The patient was not recovered from the event sick, while patient was recovering from all other events. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/21/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Fatigue', 'Headache', 'Illness', 'Malaise']",1,PFIZER\BIONTECH,OT 1076725,MA,52.0,F,"feel tired/more tired; mind felt foggy; feel achy throughout body; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration (at the age of 52-years-old) on 01Feb2021 12:30 at a single dose in left arm for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Bactrim and clarithromycin and experienced allergies. The patient experienced feel tired/more tired, mind felt foggy, feel achy throughout body all on 01Feb2021 14:30 with outcome of recovering. The patient reported that ""Approximately 1 hr (as reported) after receiving the vaccine, I started to feel tired, and my mind felt foggy. A few hours later, I began to feel achy throughout body and more tired. Next morning continued to feel achy but not as tired."" No treatment received for the events. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were assessed as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Fatigue', 'Feeling abnormal', 'Pain']",1,PFIZER\BIONTECH, 1076726,MI,65.0,F,"very bad nausea; Throwing up mucus 5 times last sat.; 99.1 temp; dizzy/ think the dizziness was for the need of a blood transfusion, which I got Tues after vaccine; head ache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration (at the age of 65-years-old) on 28Jan2021 10:30 at a single dose in right arm for COVID-19 immunization. Medical history included anemia with blood transfusions, fat, diabetic, constipation, sinus, and manic depression, allergies, immune compromise. Concomitant medication included cyclosporine, lithium, metformin, omeprazole (OMPRAZOLE), paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]). The patient reported, ""I am immune compromise. I have had some of these health complaints ongoing. The vaccine made the problems worst. Can you tell me what the 2nd dose will do to me? I think the dizziness was for the need of a blood transfusion, which I got Tues after vaccine."" The patient experienced very bad nausea, throwing up mucus 5 times last Sat., 99.1 temp, dizzy/ think the dizziness was for the need of a blood transfusion, which I got Tues after vaccine, head ache; all on 30Jan2021 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature: 99.1 on 30Jan2021, SARS-CoV-2 test: negative on 01Feb2021. Unknown if treatment received for the adverse events. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events resulted Emergency room/department or urgent care. The case was assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/30/2021,2.0,UNK,CYCLOSPORINE; LITHIUM; METFORMIN; OMPRAZOLE; PAXIL [PAROXETINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Allergy (known allergies: yes); Anemia (anemia with blood transfusions); Blood transfusion; Body fat disorder; Constipation; Diabetic; Immunocompromised; Manic depression; Sinus disorder,,,"['Body temperature', 'Dizziness', 'Headache', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test', 'Vomiting']",1,PFIZER\BIONTECH, 1076727,FL,57.0,F,"became very sore under my armpit and now it is very swollen and sore; became very sore under my armpit and now it is very swollen and sore; This is a spontaneous report from a contactable other health professional (patient). A 57-year-old non-pregnant female patient received second dose of BNT162B2 (Solution for injection, Batch/Lot number: 9262) via an unspecified route of administration in the left arm on 31Jan2021 at 09:15 (at the age of 57-years-old) as a single dose for Covid-19 immunisation. Medical history included diabetes. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included metformin hydrochloride/sitagliptin phosphate monohydrate (JANUMET) and rosuvastatin. The patient previously received first dose of BNT162B2 in left arm on 10Jan2021 at 01:15 PM for Covid-19 immunisation. The patient stated two days after 2nd vaccine, 02Feb2021, she became very sore under her armpit & now it was very swollen and sore. Seriousness criteria was considered as non-serious. No treatment was received for the adverse events. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,02/02/2021,2.0,UNK,JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE MONOHYDRATE]; ROSUVASTATIN,,Medical History/Concurrent Conditions: Diabetic,,,"['Axillary pain', 'Swelling']",2,PFIZER\BIONTECH, 1076728,PA,42.0,F,"Diarrhea; severe abdominal pain; This is a spontaneous report from a non-contactable nurse. A 42-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Pfizer COVID-19 vaccine; lot number: EN5318; expiration date: unknown) at vaccination age of 42-year-old via an unspecified route of administration in the right arm on 31Jan2021 at a single dose for covid-19 immunization. Medical history included Pcos (polycystic ovaries). The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no known allergies. Concomitant medication included unspecified medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of bnt162b2 (BNT162B2 reported as Pfizer COVID-19 vaccine; lot number: EL3246; expiration date: unknown) at vaccination age of 42-year-old intramuscular in the left arm on 11Jan2021 09:00 AM at a single dose for covid-19 immunization. The patient received the most recent COVID-19 vaccine in a hospital. On 01Feb2021 12:00 PM, the patient had diarrhea and severe abdominal pain staring 24 hours post second vaccine which lasted for 24 hours. The patient did not receive treatment for the adverse events. The patient has not been tested for COVID-19 since vaccination. The events were non-serious. The outcome of the events was recovered on 02Feb2021 12:00. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/31/2021,02/01/2021,1.0,PVT,,,Medical History/Concurrent Conditions: Polycystic ovarian syndrome,,,"['Abdominal pain', 'Diarrhoea']",2,PFIZER\BIONTECH, 1076729,,,F,"severe leg and hip pain; severe leg and hip pain; painful to walk; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 21Jan2021, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Feb2021, the patient developed severe leg and hip pain, making it painful to walk. The patient asked if these were from the vaccine. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,02/02/2021,12.0,UNK,,,,,,"['Arthralgia', 'Pain', 'Pain in extremity']",1,PFIZER\BIONTECH, 1076730,,17.0,F,"Fatigue; Headache; Fever; Dizziness; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient (not pregnant) received the second dose bnt162b2 (BNT162B2, lot/batch number and expiry date were not reported), via an unspecified route of administration in left arm on 29Jan2021 13:00 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She had her first dose of bnt162b2 on 08Jan2021 in the left arm. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 17:00, the patient had deadache, fever, dizziness and fatigue. No treatment was reported. The outcome of events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,WRK,,,,,,"['Dizziness', 'Fatigue', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH, 1076731,NC,67.0,F,"elevated transaminase measurement; Severe abdomen pain; abdomen swelling; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer. A 67-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el 3247), via an unspecified route of administration on the left arm on 28Jan2021 10:15 at a single dose (at the age of 67-years-old) for COVID-19 immunization. The patient was administered in a public health clinic/administration facility. Medical history included asthma, diabetes, high blood pressure and anxiety. The patient had unspecified concomitant therapy. The patient preciously took enalapril and sulfur and experienced drug allergies: ""Allergies to medications, food, or other products: Sulfur, Enalapril"". The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 at 21:30, the patient experienced severe abdomen pain, abdomen swelling, chills, nausea, vomiting and elevated transaminase measurement. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received unspecified treatment for the adverse events. The patient underwent lab tests and procedures in 2021 which included CT scan, comprehensive metabolic, Random amplification of polymorphic DNA (Rapd) and ultrasound all with unknown results; on 30Jan2021 elevated transaminase; and on 31Jan2021 a negative nasal swab (SARS-CoV-2 test). The events were considered non-serious by the reporter: not resulted in death, not life threatening, did not cause or prolong hospital, not disabling/incapacitating and not a congenital anomaly/birth defect. The patient has not recovered from the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/30/2021,2.0,PUB,,,Medical History/Concurrent Conditions: Anxiety; Asthma; Blood pressure high; Diabetes,,,"['Abdominal distension', 'Abdominal pain', 'Chills', 'Computerised tomogram', 'Metabolic function test', 'Nausea', 'Polymerase chain reaction', 'SARS-CoV-2 test', 'Transaminases', 'Transaminases increased', 'Ultrasound scan', 'Vomiting']",UNK,PFIZER\BIONTECH, 1076732,MI,69.0,F,"They both had COVID after the 15th, after the first shot; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. This consumer (wife) reported similar events for herself and her husband. This is 1st of 2 reports. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization . Medical history included blood pressure measurement. Concomitant medications were not reported. The wife reported that on 25Jan2021, she and her husband both had COVID after the 15th, after the first shot. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 25Jan2021. She reported that they were done with quarantine that day, 03Feb2021. Therapeutic measure was taken as a result of the event that included Zepac. And then, her husband took an additional like a steroid. She did not know what he took. But they both took Zepac and their doctor prescribed Zepac, and then her husband took a steroid too. Clinical outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021133498 Same reporter/product,events, different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/25/2021,10.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure,,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1076733,MI,34.0,M,"Lethargy; Muscle and Joint Pain; Muscle and Joint Pain; random Tremors; This is a spontaneous report received from a contactable consumer (patient). A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 31Jan2021 10:45, at single dose, for COVID-19 immunization. Medical history included HIV undetectable. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient has no allergies to medications, food, or other products. Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY); clonazepam; divalproex sodium (DIVALPROEX SODIUM ER); and lurasidone hydrochloride (LATUDA). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 01Feb2021, the patient experienced lethargy, muscle and joint pain, and random tremors. No treatment was given for the events. The patient underwent lab test which included Blood HIV RNA on an unspecified date with result HIV undetectable. The outcome of the events was not resolved. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,02/01/2021,1.0,UNK,BIKTARVY; CLONAZEPAM; DIVALPROEX SODIUM ER; LATUDA,,Medical History/Concurrent Conditions: HIV disease,,,"['Arthralgia', 'Blood HIV RNA', 'Lethargy', 'Myalgia', 'Tremor']",1,PFIZER\BIONTECH, 1076734,,46.0,F,"body aches; chills; pain at injection site; tiredness; This is a spontaneous report from a non-contactable consumer who reported for herself. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3248, via an unspecified route of administration in the left arm on 01Feb2021 01:15 PM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination and patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3248, via an unspecified route of administration in the left arm on 12Jan2021 03:15 PM for COVID-19 immunization. On an unspecified date, the patient experienced body aches, chills, pain at injection site and tiredness. No treatment was received for the adverse events. Since the vaccination, patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,,,WRK,,,,,,"['Chills', 'Fatigue', 'Pain', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1076735,TN,64.0,F,"shingles; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female (also age at vaccination) patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EL3248), via an unspecified route of administration at the left arm on 19Jan2021 at SINGLE DOSE for covid-19 immunization. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899) on 29Dec2020 10:00 AM at the left arm for covid-19 immunization. The patient is not pregnant at time of vaccination and was vaccinated at a hospital. Medical history included breast cancer, lichen planus, hypothyroid, allergies to Sulfa drugs and environmental. The patient was not diagnosed with COVID-19 prior to vaccination and since vaccination the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient also received other medications within 2 weeks of vaccination (unspecified). The patient experienced shingles on 28Jan2021 08:00 AM (diagnosed on 02Feb2021). The event resulted in Doctor or other healthcare professional office/clinic visit. It was reported that treatment received for the adverse event includes: clinic visit and medication. The outcome of the event was recovering. Case was considered as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/28/2021,9.0,PVT,,,Medical History/Concurrent Conditions: Breast cancer; Environmental allergy; Hypothyroidism (hypothyroid); Lichen planus; Sulfonamide allergy (Sulfa drugs allergy),,,['Herpes zoster'],2,PFIZER\BIONTECH, 1076736,IL,47.0,F,"Severe headache; lightheadedness; weakness; fatigue; muscle and joint pain; muscle and joint pain; swelling in left armpit; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9Z61), via an unspecified route of administration on 01Feb2021 at 10:00 at a single dose on the left arm for COVID-19 immunization. Medical history included diabetes, hypertension (HTN), depression and polycystic ovarian syndrome (PCOS) all from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 (lot number: EJ1686) on 11Jan2021 at 10:00 on the left arm for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe headache, lightheadedness, weakness, fatigue, muscle and joint pain and swelling in left armpit on 02Feb2021. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/02/2021,1.0,WRK,,,Medical History/Concurrent Conditions: Depression; Diabetes; Hypertension; Polycystic ovarian syndrome,,,"['Arthralgia', 'Asthenia', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Swelling']",2,PFIZER\BIONTECH, 1076737,CA,31.0,F,"enlarged lymph nodes; This is a spontaneous report from a contactable other healthcare professional (HCP). A 31-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date: unknown), via intramuscular route on her left arm on 22Jan2021 13:00 to 22Jan2021 13:00 at single dose for covid-19 immunization. The patient's medical history included pseudo tumor, latex allergy, retinol allergy and ovarian cyst. Concomitant medication included amitriptyline for unspecified indication. On 01Feb2021, the patient experienced enlarged lymph nodes. The outcome of the event was not recovered. The seriousness of the event was non-serious. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,02/01/2021,10.0,PVT,AMITRIPTYLINE,,Medical History/Concurrent Conditions: Drug allergy; Latex allergy; Ovarian cyst; Pseudotumor,,,['Lymphadenopathy'],1,PFIZER\BIONTECH,OT 1076738,VA,24.0,F,"Hives; This is a spontaneous report from a contactable other hcp reported for herself. A 24-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular on the left arm, at the age of 24 years, on 30Jan2021 10:45 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of COVID vaccine BNT162B2 (lot number: EK9262) at the age of 24 years on 09Jan2021 in the left arm at single dose for COVID-19 immunization. The patient experienced hives on 30Jan2021 11:00. No treatment was received for the event. The outcome of the event was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,PVT,,,,,,['Urticaria'],2,PFIZER\BIONTECH,OT 1076739,CA,35.0,F,"severe swollen lymph nodes in left clavicle and left underarm; headache; burning/heat in eyes; fatigue / Third day had generalized fatigue; chills; fever; full body joint pain; nausea; muscle aches; heavy headed feeling; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 11:30 at a single dose for COVID-19 immunization. The first dose was received on 29Dec2020 (lot number: EL1284) on the left arm. Medical history included sulfa allergy. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccine and did not had any other medications within 2 weeks of vaccination. On 19Jan2021 13:30, 2 hours after vaccine, patient developed headache and burning/heat in eyes and fatigue. On the first night (19Jan2021), she had chills, fever, full body joint pain, nausea, muscle aches and heavy headed feeling. Next morning on 20Jan2021, she had severe swollen lymph nodes in left clavicle and left underarm. Second night on 20Jan2021, patient had fever, chills, muscle aches. Third day on 21Jan2021, she had generalized fatigue and ongoing severe lymph node swelling. No treatment was received. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination. The reporter considered the events non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Sulfonamide allergy (allergies: Sulfa),,,"['Arthralgia', 'Chills', 'Eye irritation', 'Fatigue', 'Head discomfort', 'Headache', 'Lymphadenopathy', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH, 1076740,MI,30.0,M,"headache; body aches; fatigue; pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient, who is also 30-year-old at the time of vaccination, received second dose of bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration on left arm on 02Feb2021 15:30 as SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN). The patient received first dose of BNT162B2 on 14Jan2021 at 03:45 PM, lot number not reported; vaccine location=Left arm. On 03Feb2021 07:00, the patient experienced headache, body aches, and fatigue as well as pain at the injection site. The outcome of the events was recovering. No treatment was given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/03/2021,1.0,WRK,ASPIRIN [ACETYLSALICYLIC ACID],,,,,"['Fatigue', 'Headache', 'Pain', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1076741,NY,78.0,F,"shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264), via an unspecified route of administration at the left arm on 31Jan2021 16:30 at a single dose for COVID-19 immunization. The patient's medical history included atrial fibrillation, pre-diabetic, and high blood pressure. The patient's concomitant medications included sacubitril valsartan sodium hydrate (ENTRESTO) on Oct2020 for heart failure, metoprolol on an unspecified date for atrial fibrillation, and apixaban (ELIQUIS) on an unspecified date in 2018 for blood thinner. The patient experienced shortness of breath on 31Jan2021 20:00. The vaccination facility type was not a military facility. The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,01/31/2021,0.0,UNK,ENTRESTO; METOPROLOL; ELIQUIS,,Medical History/Concurrent Conditions: Atrial fibrillation; Blood pressure high; Pre-diabetic,,,['Dyspnoea'],1,PFIZER\BIONTECH, 1076742,FL,65.0,F,"Sore arm; This is a spontaneous report from a contactable consumer (patient)�. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 11Jan2021 at 12:00 (at the age of 65-years-old) at a single dose for COVID-19 immunisation. Medical history included osteoporosis, stroke history (35-years-old), significant lactose intolerance, gastrointestinal (GI) issues, and allergy to Caine family of drugs. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included evolocumab (REPATHA SURECLICK) and lorazepam (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced sore arm in 2021. The event was reported as non-serious. The patient did not receive any treatment for the event. The clinical outcome of sore arm was recovered in 2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,,,PVT,REPATHA SURECLICK; LORAZEPAM,,Medical History/Concurrent Conditions: Drug allergy; Gastrointestinal disorder; Lactose intolerance; Osteoporosis; Stroke (35-years-old),,,['Pain in extremity'],1,PFIZER\BIONTECH, 1076743,NY,41.0,M,"shingles on face and near eye; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old male patient received second dose of BNT162B2, lot no. EL3249, via an unspecified route of administration (left arm) on 27Jan2021 05:00 PM at a single dose for Covid-19 immunization at a hospital. Medical history included HTN (hypertension). No allergies to medications, food, or other products. Concomitant medications included losartan, colecalciferol (VIT D3), cyanocobalamin (B 12), ubidecarenone (COQ 10), and fish oil. Historical vaccine included first dose BNT162B2 for Covid-19 immunization on 06Jan2021 05:00 PM (left arm, lot no. EK9231). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient experienced shingles on face and near eye on 30Jan2021 that required doctor or other healthcare professional office/clinic visit. It was treated with Valtrex. The event was reported as non-serious (did not result to death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, and not congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/30/2021,3.0,PVT,LOSARTAN; VIT D3; B 12; COQ 10; FISH OIL,,Medical History/Concurrent Conditions: Hypertension,,,['Herpes zoster'],2,PFIZER\BIONTECH, 1076744,TX,57.0,M,"Difficulty breathing; breathing issues; Fever/102.3 F temp/100.3 F temp; General lethargy; Feeling tired; Some coughing; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262), via an unspecified route of administration on the left arm on 27Jan2021 17:15 at single dose for COVID-19 immunisation. Medical history included coronary heart disease, diabetes, high cholesterol, blood pressure, known allergies: tape and hay fever. The patient's concomitant medications were not reported. On 27Jan2021, fever started 2 hours after injection. Two days of fever, general lethargy and feeling tired. Third day started out good, but by 8PM, patient stated, ""I was running a 102.3 F temp (30Jan2021). Next morning I as having difficulty breathing. So on advice of a Teledoc I went to an ER for chest XRAYS. They told me they believed it was continuing issues with the vaccinations. 168 hours after injection I am running a 100.3 F temp (03Feb2021), still feeling tired, having some coughing and breathing issues"". The patient received no treatment. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Adhesive tape allergy; Blood pressure abnormal; Coronary heart disease; Diabetes; Hay fever; High cholesterol,,,"['Body temperature', 'Chest X-ray', 'Cough', 'Dyspnoea', 'Fatigue', 'Lethargy', 'Pyrexia', 'Respiration abnormal']",1,PFIZER\BIONTECH, 1076745,,,U,"I was awoke by pain in the back of my neck and right side of my body; I was awoke by pain in the back of my neck and right side of my body/ I try to lift up my head of the pillow and trying to lift my head of the pillow was extreme pain; I am little bit tired; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) solution for injection, via an unspecified route of administration on 02Feb2021 at 1:00 PM at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer COVID vaccine at a drug store yesterday (02Feb2021) at 1:00 PM and everything was fine. After eating his/her dinner, the patient was a little bit tired and went to sleep at 9:00 PM. When the patient got up around midnight, he/she was awaken by pain in the back of his/her neck and the right side his/her body. The patient tried to lift his/her head of the pillow, but it was extremely painful. So, the patient pulled a smaller pillow afterwards and had to use his/her hand to lift the head to get the other pillow underneath the patient's head, but the pain was so bad. This morning, the pain was not quite as bad but the patient still couldn't, like if the patient tried to sit up straight to turn the head to see something, it was like somebody hit him/her in the back of the head with the bat or like an object, like the patient was in a car accident or something. The patient was going to take ibuprofen (ADVIL) but was told that he/she could take paracetamol (TYLENOL) or ADVIL if you have a side effect, the patient went on the internet and some of the websites said that it could lessen the effectiveness of the vaccine, so he/she didn't take ADVIL because the patient did not want to weaken or lessen the vaccine. The patient wanted to know if he/she should take ADVIL; if ADCIL will erase the vaccine; or if it will be bad if the patient take ADVIL for pain. The patient clarified that he/she did not take ADVIL or TYLENOL yet. The outcome of the event pain was recovering and unknown for all other events. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,PHM,,,,,,"['Fatigue', 'Neck pain', 'Pain']",UNK,PFIZER\BIONTECH, 1076746,NY,70.0,F,"diagnosed with shingles (on Scalp); This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration on 25Jan2021 09:00 in left arm at single dose for covid-19 immunisation. Medical history included CAD (coronary artery disease), allergies: cosmetics, some topical meds, preservatives in eye drops and some perfume. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included atorvastatin (LIPITOR) at 40mg, acetylsalicylic acid (ASPIRIN) at 81mg and fexofenadine hydrochloride (ALLEGRA). The patient historical vaccine included varicella zoster vaccine rge (CHO) (SHINGRIX) and shingles vaccine (unspecified) for shingles, and previously took codeine and experienced allergies: Codeine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Feb2021 22:00, the patient experienced shingles (on scalp). The patient has received both the Shingrix Vaccine and the earlier Shingles Vaccine. So, it doesn't make sense. The seriousness criteria were considered as non-serious. Since the vaccination, the patient has been not tested for COVID-19. Therapeutic measures were taken as a result of diagnosed with shingles (on scalp) included valaciclovir 21 tablets. The outcome of the event shingles was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/03/2021,9.0,UNK,LIPITOR [ATORVASTATIN]; ASPIRIN [ACETYLSALICYLIC ACID]; ALLEGRA,,Medical History/Concurrent Conditions: Allergy to topical drugs; Coronary artery disease; Cosmetic allergy; Perfume sensitivity; Reaction to preservatives (.),,,['Herpes zoster'],1,PFIZER\BIONTECH, 1076747,CT,52.0,M,"Swelling, tenderness and stiffness at the injection site; Swelling, tenderness and stiffness at the injection site; Swelling, tenderness and stiffness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3247), via an unspecified route of administration in the left arm on 04Feb2021 at 11:00 AM at the age of 52 years old at a single dose for COVID-19 Immunization at workplace clinic. The patient medical history was none. Allergies to medications, food, or other products was none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive other medications within 2 weeks of vaccination. On 04Feb2021 at 15:00, the patient experienced swelling, tenderness and stiffness at the injection site, developed approximately 4-5 hours after injection. Stiffness disappeared overnight; swelling and tenderness increased overnight (now 21 hours post injection). Area was very tender, didn't affect ability to execute job function. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the event stiffness on an unspecified date in Feb2021 and recovering from other events. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Musculoskeletal stiffness', 'Vaccination site pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 1076748,CA,64.0,U,"Severe drenching sweating; heat intolerence.; administration date: dose 2: 20Jan2021; dose 1: 19Dec2020; This is a spontaneous report from a contactable physician (patient). A 64-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: el8982), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included sulpha allergy. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: ek5730) via an unspecified route of administration at the right arm on 19Dec2020 for COVID-19 immunization. On 23Jan2021, the patient experienced severe drenching sweating without fever or chills with any exertion. The patient also experienced heat intolerance. No treatment was received for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The outcome of the events were not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/20/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,"['Hyperhidrosis', 'Inappropriate schedule of product administration', 'Temperature intolerance']",2,PFIZER\BIONTECH, 1076749,MA,,F,"got Covid after receiving the first dose; got Covid after receiving the first dose; This is a spontaneous report from a Pfizer-sponsored program . A contactable healthcare professional reported a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# not provided), via an unspecified route of administration on 16Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that had a patient who received the first dose of COVID 19 vaccine shot on 16Jan2021 then the patient got COVID after receiving the first dose but recovered in 2021. The reporter was asking if the patient can still take the second dose due on 06Feb2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/16/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1076750,NY,,F,"Today she had a fever of 102.3/ has been about 101.3 most of the day; Body aches; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient), reported for a female patient of an unspecified age received bnt162b2 (BNT162B2, lot/batch number and expiry date were not reported), via an unspecified route of administration on 02Feb2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 03Feb2021, she had a fever of 102.3. She took some Tylenol and it went away but came back and had been about 101.3 most of the day. She also had body aches on 03Feb2021. The outcome of fever was not recovered; for body aches was unknown. Information on the Lot/Batch Number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/03/2021,1.0,UNK,,,,,,"['Body temperature', 'Pain', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1076751,NY,,F,"having rashes after 1st dose; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program Pfizer First Connect. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient would like to know if it was considered severe for having rashes after 1st dose. The rashes started on an unspecified date with unknown outcome. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Rash'],1,PFIZER\BIONTECH, 1076752,,,F,"swelling under both eyes; This is a spontaneous report based on the information received by Pfizer from other agency (reference number: GL-012221-1896). A contactable consumer (patient) reported that a female patient of unspecified age received BNT162B2, via an unspecified route of administration on 18Jan2021 at a single dose for COVID-19 immunization; and hyaluronic acid (RESTYLANE) via an unspecified route of administration from 23May2020 to an unspecified date at an unspecified dose and frequency for tear troughs. Medical history and concomitant medications were not reported. The patient received COVID Vaccine (Pfizer) on 18Jan2021. The patient reported swelling under both eyes on 19Jan2021 treated with prednisone per HCP. The action taken in response to the event for hyaluronic acid was unknown. The outcome of the event was not recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,05/23/2020,01/19/2021,241.0,UNK,,,,,,['Periorbital swelling'],UNK,UNKNOWN MANUFACTURER, 1076753,,,F,"coughing; not feeling well; sneezing; running nose; tired; headache; nausea; muscle pain; cold like symptoms; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# not provided), via an unspecified route of administration on 28Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID vaccine on 06Jan2021 and second vaccine on 28Jan2021. She mentioned that she experienced reaction with both vaccines. After first vaccine she has swollen and tender lymph nodes, coughing, not feeling well, sneezing, running nose, tired, headache, nausea, muscle pain, cold like symptoms (AER 2021112057). With second dose, she had similar symptoms, but ""not the swollen and tender lymph nodes, no chills or fever"". She said she felt like she was going all over this again. Outcome of the events were unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,,,UNK,,,,,,"['Cough', 'Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Nasopharyngitis', 'Nausea', 'Rhinorrhoea', 'Sneezing']",2,PFIZER\BIONTECH, 1076754,IL,22.0,F,"Chills; fever; headache; body aches; This is a spontaneous report from a contactable other healthcare professional (patient). A 22-year-old female patient, who is also 22-year-old at the time of vaccination, received bnt162b2 (BNT162B2), lot number: EL9265, via an unspecified route of administration on Left arm on 02Feb2021 10:00 as single dose for COVID-19 immunization. Medical history included Peanuts, tree nuts, cat allergy. The patient received first dose of BNT162B2, lot number not reported, on 12Jan2021, 11:00 AM on left arm. Concomitant medication included fluoxetine hydrochloride (PROZAC). On 02Feb2021, the patient experienced Chills, fever, headache, body aches. The outcome of the events was recovering. No treatment was received for the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,PVT,PROZAC,,Medical History/Concurrent Conditions: Allergy to animals; Food allergy; Peanut allergy,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1076756,,,F,"experienced a sore arm after 1st dose of the COVID 19 vaccination; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a sore arm after 1st dose of the COVID 19 vaccination. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1076762,OH,41.0,F,"Pt was released after 15 min of monitoring. As soon as pt got in her car 9Parking lot is 3 minutes away from vaccination site) Pt developed palpitations (HR:156/min) Pt drove to the ER (3 blocks away from parking lot) Pt is currently in the ER, HR between 107-119.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/05/2021,03/05/2021,0.0,PUB,UNK,UNK,UNK,,UNK,"['Heart rate increased', 'Palpitations']",UNK,JANSSEN,IM 1076766,,51.0,F,"Muscle soreness at injection site. Chills starting 18 hours after injection & lasting for several hours.; Muscle soreness at injection site. Chills starting 18 hours after injection & lasting for several hours.; This is a spontaneous report from a non-contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot EL3248), via an unspecified route of administration in the right arm 02Feb2021 08:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included high blood pressure. She had her first dose of bnt162b2 (lot EL3248) in the right arm and she had muscle soreness at injection site. Concomitant medications included lisinopril, amlodipine and potassium. The patient experienced muscle soreness at injection site and chills starting 18 hours after injection & lasting for several hours on 02Feb2021, no treatment reported. The outcome of events recovered. No follow up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,WRK,LISINOPRIL; AMLODIPINE; POTASSIUM,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Chills', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1076767,CA,64.0,F,"As the needle was being inserted and while the vaccine was being injected, I immediately felt intense pain like none I've had during any prior vaccine administration . The needle was inserted very high on the arm about 1/2 inch below the shoulder. About 4:00 pm that afternoon, new pain developed in the same shoulder, along with very limited range of motion, gradually worsening during next few hours. By 9:00pm the pain was excruciating, like there were multiple knives in all directions in my shoulder. By then I could not lift or move my arm any amount in any direction without excruciating pain. I suspected a severe inflammatory response. This pain level continued for the next 2 days. On the 3rd day the pain was a little less severe and I had slightly more range of motion, but was still unable to lift my arm without pain. On the 4th day (Feb. 18) the pain was a little better but I still had severe sharp pain if I lifted my arm in certain directions. I began to suspect a torn muscle or tendon. Today (March 5, almost 3 weeks after the vaccine), the pain and limited range of motion are the same as Feb. 18. It is relieved only by complete rest of the arm, and easily aggravated by any basic activity (grocery shopping, dressing, etc.) I believe my shoulder was injured by improper administration.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/14/2021,02/14/2021,0.0,UNK,Multivitamin,None,None,,None,"['Immediate post-injection reaction', 'Injected limb mobility decreased', 'Injection site pain', 'Joint range of motion decreased', 'Loss of personal independence in daily activities', 'Pain', 'Product administered at inappropriate site']",2,PFIZER\BIONTECH,IM 1076768,NM,70.0,F,Acute GI bleed requiring ICU care and transfusion,Not Reported,,Yes,Yes,8.0,Not Reported,Y,02/22/2021,02/27/2021,5.0,PVT,"Taking CoQ-10 100 MG Capsule Extended Release, Sig: 1 capsule with a meal Orally Once a day Taking Pramipexole Dihydrochloride 0.125 MG Tablet, Sig: 1 tablet before bedtime Orally Once a day Continue Trulicity 1.5 MG/0.5ML Solution Pen-",Had been started on high-dose prednisone for IGA nephropathy about 2 months prior,"I10 Essential (primary) hypertension 24-hour monitor 11/18 showed elevated BP throughout day 10/12/2015 06/23/2020 E78.0 Pure hypercholesterolemia 7/14 10-year risk of heart disease = 35.4% 9/15 10-year risk = 14.4% 10/12/2015 06/23/2020 M85.80 Osteopenia osteopenia on bone density 2005, treated with Fosamax, nl bone density 2011, Fosamax discontinued at that time. Bone density 2/16 shows minimal osteopenia, does not need treatment. Recheck 2019 showed normal bone density. 10/12/2015 06/23/2020 N95.1 Menopausal and female climacteric states on hrt, willing to try weaning off again 10/12/2015 06/23/2020 M17.9 Osteoarthritis of knee, unspecified s/p bilateral tka 10/12/2015 06/23/2020 E11.9 Type 2 diabetes mellitus without complications 10/12/2015 01/05/2021 Z86.010 Personal history of colonic polyps 2/12, diagnosed on colonoscopy. Pathology showed colonic mucosa with no atypia. Normal colonoscopy 2014. 10/12/2015 06/23/2020 N39.3 Stress incontinence (female) (male) 10/12/2015 06/23/2020 E55.9 Vitamin D deficiency, unspecified 10/12/2015 06/23/2020 E53.8 Vitamin B12 deficiency 10/12/2015 06/23/2020 E11.319 Diabetic retinopathy Diagnosed 5/13 12/08/2015 06/23/2020 K21.9 Esophageal reflux 02/10/2016 06/23/2020 G25.81 Restless leg syndrome 05/22/2017 06/23/2020 D69.6 Thrombocytopenia 07/24/2017 06/23/2020 M54.32 Sciatica of left side 09/12/2017 06/23/2020 R31.21 Asymptomatic microscopic hematuria 03/06/2018 06/23/2020 R80.0 Isolated proteinuria without specific morphologic lesion 03/06/2018 06/23/2020 R93.1 High coronary artery calcium score 03/06/2018 06/23/2020 N90.4 Lichen sclerosus et atrophicus of the vulva Biopsy confirmed 4/18. 03/16/2018 06/23/2020 M54.42 Lumbago with sciatica, left side 03/16/2018 06/23/2020 N18.3 Chronic kidney disease (CKD) stage G3a/A3, moderately decreased glomerular filtration rate (GFR) between 45-59 mL/min/1.73 square meter and albuminuria creatinine ratio greater than 300 mg/g",,"Baclofen - rash, Tizanidine HCl - rash, Pneumococcal Vac Polyvalent - arm became red and swollen, Acarbose - abdominal pain, flatulence","['Gastrointestinal haemorrhage', 'Intensive care', 'Transfusion']",UNK,MODERNA,IM 1076774,NC,33.0,M,"Severe body ache; ache at the injection site; headache; chills; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration in the left arm on 18Feb2021 at 12:00 (at the age of 33-years-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not aware of allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient previously took first dose of BNT162B2 (Lot number: EL3247 and left arm) on 28Jan2021 at 12:30 (at the age of 33-years-old) for COVID-19 immunization. On 18Feb2021 at 23:00 severe body ache, ache at the injection site, headache and chills. The seriousness criteria were considered as non-serious. The patient did not receive any treatment of the events. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,WRK,,,,,,"['Chills', 'Headache', 'Pain', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1076781,NJ,62.0,M,"Broken bones; Fever 102.2; General weakness; Injection site pain; This is a spontaneous report from a contactable other health professional reported for himself. A 62-year-old male received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Feb2021 08:15 on Arm left at single dose (Lot # EL9267) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. He experienced Fever 102.2, broken bones, general weakness and injection site pain on 17Feb2021, which were non serious. Tylenol were received for the events. The patient had not been tested for COVID-19. Outcome of the events was recovered.; Sender's Comments: The event broken bones was considered as an intercurrent condition and unrelated to the use of BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/17/2021,1.0,PVT,,,,,,"['Asthenia', 'Body temperature', 'Multiple fractures', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1076792,SC,81.0,M,"Developed watery diarrhea; malaise; weight loss; collagenous colitis on colonoscopy biopsies; This is a spontaneous report from a contactable physician (patient). An 81-years-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included was none. No covid prior vaccination. No known allergies. Concomitant medication included allopurinol (ALLOPURINOL), losartan potassium (COZAAR), tadalafil (TADALAFIL), acetylsalicylic acid (ASPRIN), simvastatin (ZOCOR). Historical vaccine included BNT162B2 details: (Product= COVID 19) for covid-19 immunisation, Lot number= EL1284, Administration date= 31Dec2020, administration time= 11:00 AM, vaccine location: Left arm, dose number= 1, Developed watery diarrhea about 5 days after the dose. No other vaccine in four weeks. Adverse event: watery diarrhea improved somewhat but worsened again after the second dose of vaccine, along with some malaise and weight loss, since 05Jan2021. Extensive investigations eventually revealed collagenous colitis on colonoscopy biopsies in Jan2021. May well be coincidence, but interested to know if others have been reported. AE resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Anti-diarrheals, budesonide. The event outcome of collagenous colitis was recovering, watery diarrhea was not recovered, outcome of other event was unknown. Covid test post vaccination covid test date=19Jan2021, which was negative.; Sender's Comments: Based on the available information, the company considers that a causal relationship between collagenous colitis on colonoscopy biopsies and bnt162b2 cannot be excluded due to plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021229604 same patient/reporter, different AE/first dose",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/01/2021,01/01/2021,0.0,PVT,ALLOPURINOL; COZAAR; TADALAFIL; ASPRIN; ZOCOR,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Biopsy', 'Colitis microscopic', 'Colonoscopy', 'Diarrhoea', 'Malaise', 'SARS-CoV-2 test', 'Weight', 'Weight decreased']",2,PFIZER\BIONTECH, 1076804,MT,86.0,M,"patient 's daughter reports client very tired, body pain and confusion (delirium)",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/25/2021,02/26/2021,1.0,PVT,Levothyroxin,unknown,Unknown,,unknown,"['Confusional state', 'Delirium', 'Fatigue', 'Pain']",2,PFIZER\BIONTECH,IM 1076812,CA,76.0,M,"he violently threw up/vomiting; lost control of all of his extremities; acute pancreatitis; had no strength; affected his memory; barely moving; balance was horrible/his whole balance everything was off; lost his appetite right away; not eat; This is a spontaneous report from a contactable consumer reporting for the husband. A 76-year-old male patient received the first dose of bnt162b2 (Batch/lot number: EL3302), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunisation. Medical history included Allergy from an unknown date, blood pressure abnormal from an unknown date, ongoing kidney patient and was on dialysis three times a week. Concomitant medication included insulin aspart (NOVOLOG), insulin glargine, vitamin b complex (SUPER B COMPLEX), acetylsalicylic acid (BABY ASPIRIN), vitamin d3, ascorbic acid, biotin, folic acid, mecobalamin, nicotinic acid, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine (DIALYVITE), atorvastatin, cetirizine for Allergy, fish oil, docusate, amlodipine besilate for Blood pressure and other medications as the patient was kidney patient. For Concomitant medication amlodipine besilate, the consumer stated, Right now at this time he was not supposed to take them on his dialysis days. So, he took one tablet on Saturday & Sunday, Tuesday & Thursday. The patient had his first shot of the Pfizer on 21Jan2021, he lost his appetite right away and wasn't eating. And then on 29Jan2021 he took 2 bites of a meal, and had extremely volatile vomiting and lost control of all of his extremities. He violently threw up on the 29Jan2021 and from that's when on he had no appetite, she couldn't get him to eat anything. Her daughter had to help her pick him up of the floor, the Friday night 24 hours it was just horrible. The consumer stated, Saturday morning (30Jan2021) he had gotten use of extremities back but barely moving and still very, his whole balance everything was off. He was able stand up and use the restroom by himself. This had all affected his memory, he couldn't do his medications alone anymore and he couldn't take care of himself. And then on the 12Feb2021 the consumer took him over to the hospital because after when he vomited on the 29Jan2021 he lost all use of his extremities. They diagnosed him with acute pancreatitis, but he still, he was in the hospital from Friday 12Feb2021 and they released him on the 17Feb2021. And he still had no strength. His balance was horrible. It was affecting, whatever it was affecting his memory. The consumer stated they had no idea why he came down with acute pancreatitis and he never had any pain with it. They said they were amazed that he was not in severe pain, never any pain. The outcome of events had no strength and balance was horrible was not recovered. The outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187441 Same reporter/patient/product, Different dose/AE",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/21/2021,01/21/2021,0.0,UNK,NOVOLOG; INSULIN GLARGINE; SUPER B COMPLEX [VITAMIN B COMPLEX]; BABY ASPIRIN; VITAMIN D3; DIALYVITE; ATORVASTATIN; CETIRIZINE; FISH OIL; DOCUSATE; AMLODIPINE BESILATE,Dialysis (three times a week); Kidney disorder,Medical History/Concurrent Conditions: Allergy; Blood pressure abnormal,,,"['Asthenia', 'Balance disorder', 'Decreased appetite', 'Eating disorder', 'Memory impairment', 'Movement disorder', 'Muscle disorder', 'Pancreatitis acute', 'Vomiting']",1,PFIZER\BIONTECH, 1076820,AL,49.0,F,"She is worried it might be Bell's Palsy; had a knot at the injection site of her left arm; Tingling sensation on her upper back which went up to her neck and head/tingling in my neck, face, lips and eyes; Burning and tingling in my neck and in my face and in my lips and in my eyes; Burning and tingling in my neck and in my face and in my lips and in my eyes; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: EH9899, Expiration date: not provided), intramuscular on the left arm on 19Jan2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 49-year-old for COVID-19 immunization. The patient was worried it might be bell's palsy (medically significant) on an unspecified date. she experienced side effects on 22Jan2021 after receiving the vaccine on 19Jan2021. She had a knot at the injection site of her left arm on the first day. After 3 days, she experienced a tingling sensation on her upper back which went up to her neck and head. It was not excruciating pain but had presence to be noticed. It had been there since that day and was not going away. She had been feeling it around her eyes and on her lips. She was worried it might be Bell's Palsy. She was asking for advice and if this had been reported. As soon as she get the second Covid Shot at the 19Jan it was about 2-3 days afterwards, it was on the Friday and it was about 2' O'clock, well she had the knot in my arm, her left arm where she received the IM (Intramuscular) vaccination (Covid Shot) and she had started having the symptoms of like burning and tingling in my neck and in my face and in my lips and in my eyes and that is not gone away and I still have that knot in my arm, I still have the burning and tingling. she had some blood work done like last Thursday to see if she had any kind of like rheumatoid problems to see arthritis or something but other than that no. Consumer stated, ""Well I work in the doctor office and the Physician the one he told me to get the blood work and it goes to the doctor office because I work in one. For treatment consumer stated, she had only been taking an Advil and it did not seem to help her. The outcome of the events was not recovered. Comments/Narrative: Patient will follow up with Physician next week. She is currently on vacations.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/22/2021,3.0,PVT,,,,,,"[""Bell's palsy"", 'Blood test', 'Burning sensation', 'Eye irritation', 'Paraesthesia', 'Vaccination site swelling']",2,PFIZER\BIONTECH,OT 1076823,IA,17.0,M,The patient has had no problems with the vaccine. We were finishing vials of both Janssen and Pfizer at the same time at the end of the evening. He received a dose of Janssen when he should have received Pfizer since he will not be 18 years old for 4 months.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/03/2021,03/03/2021,0.0,PHM,none,none,none,,none,['Product administered to patient of inappropriate age'],1,JANSSEN,IM 1076830,NY,81.0,F,"She is experiencing an Allergic reaction, rash; little coughing spell; Itching eyes/My eyes started itching; Multiple hives all around her right eye; Wheezing; didn't feel comfortable; her upper lip became puffy/bottom lip began to swell; This is a spontaneous report from a contactable nurse (patient) via Medical Information Team. An 81-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6201), intramuscular at upper left arm on 21Feb2021 at 08:30 at SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccination within 4 weeks. The patient had no additional vaccines administered on same date of bnt162b2. Medical history included seasonal asthma, allergy to class A antihistamines that started in her 20s, facial & peripheral edema, blood pressure abnormal, and celiac disease. The patient had known allergy to Benadryl and when she takes it she gets peripheral and facial edema, lip swelling, top and bottom, hives around her whole right eye. The patient also has an allergy to Class A antihistamines that started in her 20s. She said the allergy started with Seldane & Claritin. She said she had giant hives with Claritin. She said she was told there were 2 classes of antihistamines & she couldn't use the Class A antihistamines. She said she previously reported her Seldane, Claritin & Benadryl allergies, saying she has facial & peripheral edema. She said she only uses the Class B antihistamine Cimetidine now. Concomitant medications included metoprolol, omeprazole, and pravastatin. On an unspecified date, the patient was experiencing an allergic reaction, rash. On 21Feb2021, the patient experienced ""her upper lip became puffy/bottom lip began to swell,"" multiple hives all around her right eye, wheezing, and didn't feel comfortable. On 21Feb2021 at 14:00 (reported as about 2PM), the patient experienced ""Itching eyes/My eyes started itching."" On 21Feb2021 at 21:00 (reported as 9PM), the patient experienced little coughing spell. The reporter considered the events swelling lips, itching eyes, multiple hives all around her right eye, and wheezing as serious medically significant. The patient further reported that she felt fine after the shot, her arm was not sore, nothing. She said her arm was fine, and she had no problems, whatsoever, after receiving the COVID-19 Vaccine. She said she has had some weird allergic reactions in the past, but no anaphylaxis. About 12:00 to 12:30 PM (also reported as around midday), the patient's lip felt puffy. She said she had ate an apple and thought maybe something was on the skin of the apple. She said then her bottom lip began to swell, so she took 3 Cimetidine (NDC Number: 49035-820-72, lot number: 9AE2576A, expiry date: Dec2020). The patient stated that she was allergic to what she believe are class A antihistamines as they gave her facial and peripheral edema including Benadryl and everything on the list. About 2PM, the patient's eyes felt itchy, she took allergy eye drops (eye drops seasonal relief with tetrahydrozoline HCL 0.05% and zinc sulfate 0.25%. She said the product packaging reads it soothes eyes, and she said the eye drops worked. Lot number: AC8K275, expiration date: Sep2021). She said when she looked in the mirror, she saw a large hive on her eye (clarified as multiple hives all around her right eye). And about 4PM, she realized that her lips felt puffy, so she repeated the Cimetidine, it kept them from getting worse. At 7PM, her eye felt worse. She had this real hive that surrounded her right eye, she took a picture so she could report it to the doctor. The patient have an appointment on Wednesday. At 7:30PM, the patient's lips were puffy, she repeated the Cimetidine again and took of the 200 mg, she takes 3 at a time, she mentioned she could take 4, but she takes 3. She said she took more Cimetidine at 8:30PM, and talked to a pharmacist, who told her to call Pfizer to report her reaction. She said she attempted to call Pfizer last night, but it was too late, clarifying Pfizer Medical Information was already closed for the day. The patient also reported that she had a little coughing spell at about 9PM, so she stayed up with her husband till 10PM because she didn't feel comfortable. The patient told her husband to wake her up every once in a while. The patient felt a little wheezy, she used both of her inhalers, she could hear the wheezing, she used the serevent diskus (Serevent Diskus 50 mcg Inhaler. She said she has been using the Serevent Diskus Inhaler for seasonal allergies for years and the inhaler works. She said she occasionally uses the Serevent Diskus for colds during the winter. She said she realized she was wheezing last night and thought she should use the Serevent Diskus. NDC Number: 0173-0521-00, Lot Number: VV3E, Expiration Date: Sep2021) and Flovent (Flovent HFA 110mcg Inhaler, NDC Number: 0170719-20, Lot Number: C47A, Expiration Date: Jul2021). That seemed to be okay, she went to bed, and had a good night no problems. She said she woke up this morning and felt better. She said she sounds a little gunky this morning, clarifying that was somewhat typical for her. The patient further reported that she got up at 6:30AM, she took a shower, she was having a rebound reaction, and wheezing, so she took 3 more Cimetidine and repeated the inhalers. She clarified while her symptoms worsened after the hot shower this morning, her symptoms are much less than yesterday (21Feb2021), saying she was aware of her symptoms today, and paying attention to them. She said her lips became puffy, and she was wheezy after the hot shower. She said she took Cimetidine and her inhalers again this morning to treat the rebound reaction. She decided to repeat again at about quarter to 10AM, she repeated again trying to keep it under control. In the meantime, she spoke to her doctors office, and they just said keep doing what she's doing, and if she get real bad, call 911 or go to emergency room (ER). The patient have an appointment, the patient's big concern was that she probably shouldn't get the second COVID shot. She read on (website), that there was a very rare, mild anaphylactic reactions. What caught her eye was that this takes place about 4 hours after the dose. This was when her symptoms began, lucky her. Her whole life has been allergy related. The patient don't know if celiac disease has anything with this. The patient wanted to know whether or not there was some way to take the shot without killing herself. She said she was not having breathing difficulty, she was just wheezy. She said she repeated the Cimetidine about a half hour before she called Pfizer today. She said she called her doctor's office this morning, and her doctor said for her to keep treating her symptoms as she had been doing. She said her doctor told her to call an ambulance or go to the emergency room if her symptoms happen to get worse. She said she read online that skin anaphylaxis (hives, itching, and swelling of the eyes, face, lips and throat) can occur with the COVID-19 Vaccine. She clarified she read the information about the COVID-19 Vaccine at (Website name). She said she read skin anaphylaxis was extremely rare and less than 1% of the population has the allergy, and those individuals should not get the COVID-19 Vaccine. She said she was upset because what she read probably means she can't get the second COVID-19 Vaccine shot. She said she read the skin anaphylaxis appears within 4 hours after getting vaccinated with the COVID-19 Vaccine. She said her symptoms occurred in almost the same amount of time as to what she read about a skin anaphylaxis reaction to the COVID-19 Vaccine. She said she has a regular check-up on Wednesday (24Feb2021) with her doctor, and will speak further to her doctor about getting the second COVID-19 Vaccine. The reporter considered the events lip felt puffy, eyes started itching, hives, and wheezing as serious medically significant. The patient had no emergency visit. The patient had no relevant tests done. Therapeutic measures were taken as a result of the events swelling lips, itching eyes, multiple hives all around her right eye, and wheezing. The patient had not yet recovered from the events swelling lips, itching eyes, multiple hives all around her right eye, and wheezing while outcome of the events rash, little coughing spell, and didn't feel comfortable was unknown. The reporter considered the events swelling lips, itching eyes, hives, and wheezing as related to bnt162b2.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/21/2021,0.0,PUB,METOPROLOL; OMEPRAZOLE; PRAVASTATIN,,"Medical History/Concurrent Conditions: Blood pressure abnormal; Celiac disease (I have Celiac Disease so I have an auto-immune disease.); Drug allergy (she has an allergy to Class A antihistamines that started in her 20s); Face edema; Peripheral edema; Seasonal asthma (since she was 18 years old, clarifying pretty much her whole life)",,,"['Cough', 'Discomfort', 'Eye pruritus', 'Lip swelling', 'Rash', 'Urticaria', 'Wheezing']",1,PFIZER\BIONTECH,OT 1076838,NJ,68.0,F,"week after the 1st dose, her Blood pressure went up to 210/101/noticed some spikes in her blood pressure; felt a weird sensation; Tingling in her head and her face; pain in the head and got increasing worse/scalp felt on fire/light headache; scalp felt on fire; she felt a little soreness in arm/12 hours my arm hurt; This is a spontaneous report from a contactable consumer (patient's cousin). A 68-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/Lot number: EL9262), via an unspecified route of administration on the left arm, at age 68 years first dose on 20Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included ongoing anxiety from an unknown date. Ongoing concomitant medication included escitalopram 5 mg for anxiety, calcium and an unspecified multivitamins. The patient had flu vaccine in Oct2020. Patient's cousin called on behalf of cousin and reported that patient was very ill for having severe reaction to the COVID Vaccine. Patient was physically fit and thin received first dose of COVID vaccine on 20Jan2021, 10:30 AM. After her 1st dose, she felt a little soreness in arm, 12 hours her arm hurt and light headache the same day. Patient went to bed a little earlier than normal and slept a little longer since she was 69 years, its her body and it needed more sleep and woke up at noon and her arm was fine and very grateful to have the shot. Two nights later, on 22Jan2021, patient woke up in the middle of the night with tingling and pain in the head and got increasing worse, her scalp also felt on fire and had tingling sensation in her face for 3 weeks. Then, a week after the 1st dose on 27Jan2021, her blood pressure went up to 210/101. She went to the hospital, they controlled her pressure and put on a pressure pill 1 a day (amlodipine). She mentioned she had felt a weird sensation on an unspecified date and as she noticed some spikes in her blood pressure, her MD told her to take another 2.5 mg amlodipine if needed (once or twice a day as needed). She confirmed she had no heart rate problems but she actually experienced high blood pressure instead. She never had numbness, instead she had a tingling sensation still present. The outcome of the event 'eek after the 1st dose, her blood pressure went up to 210/101/noticed some spikes in her blood pressure' and 'tingling in her head and her face' was not recovered, for event 'she felt a little soreness in arm/12 hours my arm hurt' was recovered on 21Jan2021, while for the other events, it was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187054 same patient/drug, different event",Not Reported,,Not Reported,Yes,,Not Reported,N,01/20/2021,01/20/2021,0.0,UNK,ESCITALOPRAM; CALCIUM,Anxiety,,,,"['Blood pressure measurement', 'Feeling abnormal', 'Headache', 'Hypertension', 'Pain in extremity', 'Paraesthesia', 'Skin burning sensation']",1,PFIZER\BIONTECH, 1076844,IL,72.0,F,"Bell's Palsy; This is a spontaneous report from a contactable Physician and a consumer. A 72-years-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in Left arm on 05Feb2021 at single dose for covid-19 immunisation. The patient medical history was not reported. No covid prior vaccination. Concomitant medication included ASA, levothyroxine sodium (SYNTHYROID), telmisartan and simvastatin (ZOCOR). There was no other vaccine in four weeks. The patient previously took lisinopril and experienced allergy. The patient experienced bell's palsy on 20Feb2021 and treated with prednisone. Event resulted in Doctor or other healthcare professional office/clinic visit. Covid did not test post vaccination. The outcome was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, the Company considered the reported serious event as possibly associated to BNT162B2 injection, due to a plausible chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/20/2021,15.0,UNK,ASA; SYNTHYROID; TELMISARTAN; ZOCOR,,,,,"[""Bell's palsy""]",1,PFIZER\BIONTECH,OT 1076852,CA,52.0,F,"palpitations; Soreness for 2.5 days; it is red and bruised/Redness; Swelling in the injection area; bruise at the injection site/bruising is about the size of a half dollar or a little bigger/bruising was purple; Warm to touch/feels hot to touch; She felt pain immediately from the injection; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 12Feb2021 at a single dose on right arm for COVID-19 vaccination. Medical history included history of reactions to vaccination (including swelling), cardiovascular disease and she had 3 stents placed in the last 3 years, ongoing coronary artery disease, small vessel disease, heart attack (when she was 50 years old. She has been having symptoms in the last could of years), blood pressure, angina, and high cholesterol. Concomitant medication included ticagrelor (BRILINTA) as blood thinner, ranolazine (RANOLAZINE EXTENDED RELEASE) for angina, rosuvastatin for high cholesterol, losartan for blood pressure, metoprolol to help her heart not work as hard, ezetimibe as cholesterol booster, and acetylsalicylic acid (ASPIRIN) as blood thinner. The patient experienced palpitations on an unspecified date which resulted in a recent hospitalization. The patient was reported to have taken the first dose of COVID-19 vaccine on 12Feb2021 and had soreness for 2.5 days since an unspecified date, then it resolved. She reported that she felt pain immediately from the injection on 12Feb2021 and some pain after the injection and she typically have reactions where she swells. On 20Feb2021, she developed a bruise at the injection site, and it was also warm to touch. The bruising was the size of a half dollar and it was hot to touch. She stated that the bruising was purple, and she never experienced that before. She wanted to know if this could be due to the vaccine. on 12Feb2021. On 21Feb2021, she had swelling in the injection area, it is red and bruised, and the bruising was about the size of a half dollar or a little bigger. The redness looked like it was a little less, but the bruising has been more prominent. She wanted to know if she should get the second dose on 05Mar2021, as scheduled, and if she does, will the reaction be worse? The patient underwent lab tests and procedures which included exploratory tests: which revealed small vessel disease on an unknown date. The outcome of the event ""Soreness for 2.5 days"" was recovered; ""She felt pain immediately from the injection"", ""it is red and bruised/Redness"" was recovering; and ""bruise at the injection site/bruising is about the size of a half dollar or a little bigger/bruising was purple"", ""Warm to touch/feels hot to touch"" and ""Swelling in the injection area"" was not recovered, and for palpitations was unknown.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/12/2021,02/12/2021,0.0,UNK,BRILINTA; RANOLAZINE EXTENDED RELEASE; ROSUVASTATIN; LOSARTAN; METOPROLOL; EZETIMIBE; ASPIRIN [ACETYLSALICYLIC ACID],Coronary artery disease,Medical History/Concurrent Conditions: Angina syndrome; Blood pressure abnormal; Cardiovascular disorder; Heart attack (When she was 50 years old. She has been having symptoms in the last could of years.); High cholesterol; Microangiopathy; Stent placement; Vaccination site swelling,,,"['Laboratory test', 'Pain', 'Palpitations', 'Vaccination site bruising', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling', 'Vaccination site warmth']",1,PFIZER\BIONTECH, 1076864,PA,,M,"Kidney stone; This is a spontaneous report from a contactable consumer (patient) from the Pfizer-sponsored program. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that last weekend (unspecified date), the patient had a kidney stone and he's receiving antibiotic (CEFLIN), 500 mg twice a day for four weeks. The patient would like to know if it's okay to receive the second dose of the vaccine while he is taking the antibiotic. The outcome of the event was unknown. The information about the batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Nephrolithiasis'],1,PFIZER\BIONTECH, 1076869,NY,53.0,M,patient c/o chest pain with EKG changes 90 min. after vaccine administered.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,PVT,Aspirin Sinemet lovenox Keppra Melatonin,"Patient was admitted to the hospital on 2/27/2021 with increased fatigue, memory issues, weakness, hallucinations and expressive aphasia occurring intermittently for 2 weeks.",anxiety depression Chronic back pain obesity seizure,,Aspirin (Bayer Brand) Penicillian Wellbutrin,"['Chest pain', 'Electrocardiogram change', 'Troponin']",1,JANSSEN,IM 1076870,FL,,M,"multiple sclerosis; Headache; prevented him to sleep; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age (reported as 67, unit unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that patient is a veteran and got the first dose of the COVID vaccine on Friday (unspecified date) and he had a strong headache that have prevented him to sleep and he could not think straight because of the pain. Patient's wife also reported that patient has multiple sclerosis and would like to know what they can do about his headache. Outcome of the events was unknown. Information on Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Headache', 'Insomnia', 'Multiple sclerosis']",1,PFIZER\BIONTECH, 1076881,NY,45.0,F,"Fainted; Fainted/aggravated it; chills; fever; Headache; body aches; All night woke up with sweats and burning; All night woke up with sweats and burning; All night woke up with sweats and burning; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the second dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 20Feb2021 08:30 at single dose for covid-19 immunization. Medical history included Vasovagal synchope, allergy to Sulfa drugs. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), metoprolol. The patient previously allergy to cipro and levaquin. The patient previously received the first dose of bnt162b2 (Lot number unknown), at the age of 45-year-old, via an unspecified route of administration in left arm on 28Jan2021 15:30 at single dose for covid-19 immunization. About 11 hours after 2nd dose (20Feb2021 19: 30), the patient got extreme chills and fever, headache and body aches. All night woke up with sweats and burning. Fainted around 21Feb2021 06:00 (patient had vasovagal synchope so maybe aggravated it). No treatment received. The patient was no pregnant. The outcome of the events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,UNK,EFFEXOR; METOPROLOL,,Medical History/Concurrent Conditions: Sulfonamide allergy; Syncope vasovagal,,,"['Burning sensation', 'Chills', 'Condition aggravated', 'Headache', 'Middle insomnia', 'Night sweats', 'Pain', 'Pyrexia', 'Syncope']",2,PFIZER\BIONTECH, 1076888,IN,65.0,F,"Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318, expiration date: May2021), via an unspecified route of administration in the left arm on 31Jan2021 at 12:30 at a single dose for COVID-19 immunization. The vaccination was done at a hospital. The patient's medical history included Reynold's syndrome (21 years old at diagnosis), Sjogren's (diagnosed at 30 years old), mixed connective tissue disease (diagnosed around 30 years old), and fibromyalgia (late 40s at diagnosis). There were no concomitant medications. The patient previously received a tetanus shot for immunization on an unspecified date and was allergic to the tetanus shot. This happened when she was 21 years old. The patient also got the new pneumonia shot on 12Jan2021 in her left arm for immunization at the age of 65 years old. The patient got her first dose of BNT162B2 on 31Jan2021. The patient stated she was supposed to get second vaccine 21Feb2021 but that she went to emergency room 13Feb2021 with extreme right eye pain and numbness in lip. She was diagnosed with Bell's palsy. The patient stated that she was not admitted to the hospital, and she just seen in the emergency room. It was reported that it initially worsened, that her eyes were definitely worse until a week later she was scheduled to see her physician and on Wednesday 17Feb2021 she started taking eye drops and now they have not gotten any worse. The doctor said it was not known if it was caused by the vaccine, and stated the patient has certain autoimmune problems Reynaud's, Sjorgen's and mixed connective tissue disorder, all diagnosed prior to vaccine. The patient had no family history relevant to the event. There were no relevant tests. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,02/13/2021,13.0,OTH,,,Medical History/Concurrent Conditions: Fibromyalgia (Verbatim: Fibromyalgia late 40s at diagnosis); Mixed connective tissue disease (Verbatim: Mixed connective tissue disease diagnosed around 30 years old); Reynold's syndrome (Verbatim: Reynold's syndrome 21 years old at diagnosis); Sjogren's (Verbatim: Sjogren's diagnosed at 30 years old),,,"[""Bell's palsy""]",1,PFIZER\BIONTECH, 1076890,CA,35.0,F,"Patient c/o weakness and feeling dizzy, EMT notified at 12:20, EMT assessed patient, VSS 157/93 HR 97 RR 26 O2 98% BGM 129 at 1430. At 1440 146/95 HR 93 RR 18 O2 95%. EMT did not administer any medications, EKG Normal sinus. Fire department recommended patient to hospital as she was alone and driving herself. Fire department escorted patient to hospital via ambulance as a precaution at 1456.",Not Reported,,Not Reported,Yes,,Not Reported,U,03/05/2021,03/05/2021,0.0,OTH,"Zoloft, Birth control, gout medication, RA medication",,"gout, anxiety, RA",,"Sulfa, PCN, Flagyl, Sulfide","['Asthenia', 'Dizziness', 'Electrocardiogram normal']",1,PFIZER\BIONTECH,IM 1076894,,72.0,M,"multiple pulmonary emboli; This is a spontaneous report from a non-contactable consumer (patient's wife) via Medical Information team. A 72-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on 10Feb2021 at a single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date were unknown) on 19Jan2021 and experienced gradually being short of breath, which was further described as ""he would walk for 50 yards and he would be huffing and puffing."" The patient's medical history and concomitant medications were not reported. It was further reported that about 8 days after the first one, the patient started noticing gradually being short of breath. He would walk for 50 yards and he would be huffing and puffing, which was unusual, because he could walk a lot. It gradually got worse and then after the second one, it continued to get worse and he finally ended up in the hospital for 3 days with multiple pulmonary emboli on an unspecified date. The reporter was asking if this had been reported with the vaccine. The patient was hospitalized for the event multiple pulmonary emboli on an unspecified date for 3 days. The outcome of the event was unknown. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/10/2021,,,UNK,,,,,,['Pulmonary embolism'],2,PFIZER\BIONTECH, 1076897,UT,42.0,M,"When I got the vaccine I got an instant pain in my arm and into my neck, then an intense headache between my eyes above my nose, I was flush and sweaty, nauseous. Then had a bad headache on the top of my head, then soon I had left side facial numbness . Light sensitivity",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/04/2021,0.0,PVT,None,No illness,Sleep apnea,,No known allergies,"['Flushing', 'Headache', 'Hyperhidrosis', 'Hypoaesthesia', 'Nausea', 'Neck pain', 'Pain in extremity', 'Photophobia']",1,JANSSEN,IM 1076900,CA,,M,"Brain bleed; This is a spontaneous report from a contactable consumer (patient himself). An elderly male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: 6201), via an unspecified route of administration at Right arm on 17Feb2021 13:30 (at unknown age) at single dose for Covid-19 immunization. Medical history included Hydrocephalus. No COVID prior vaccination. No COVID tested post vaccination. No known allergies. Other vaccine same date product was None. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318) on 26Jan2021 04:30 P.M at Right arm, for COVID-19 immunization. The patient experienced Brain bleed on 18Feb2021 16:00. AE resulted in Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 4 days. The patient underwent lab tests and procedures which included CT scan (computerised tomogram): unknown results on Feb2021. Treatment reported as CT scan/observation. The outcome of the event was Recovering.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/17/2021,02/18/2021,1.0,PUB,,,Medical History/Concurrent Conditions: Hydrocephalus,,,"['Cerebral haemorrhage', 'Computerised tomogram']",2,PFIZER\BIONTECH, 1076901,GA,18.0,F,"Asthma; Syncope; Dizziness; Nausea; Vomiting; Severe headache; Fever; Muscle weakness; Muscle twitching; Fatigue; Chest tightness; This is a spontaneous report from a contactable consumer (patient). A 18-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: Em9810), on right arm via an unspecified route of administration on 23Feb2021 10:30 at single dose for covid-19 immunisation. The patient medical history was not reported. There was no known allergy. Concomitant medication included sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 04:45PM on Arm Left for covid-19 immunisation. On 23Feb2021 10:30 patient experienced syncope (medically significant), dizziness, nausea, vomiting, severe headache, fever, muscle weakness, muscle twitching, fatigue, chest tightness, asthma. No treatment was received for the event. Patient not having COVID prior vaccination. Patient not tested COVID post vaccination. Outcome of the events was recovering.; Sender's Comments: Based on the strong temporal association, the association between the event syncope and the vaccine BNT162b2 administration cannot be completely ruled. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/23/2021,0.0,OTH,SERTRALINE; ADDERALL,,,,,"['Asthma', 'Chest discomfort', 'Dizziness', 'Fatigue', 'Headache', 'Muscle twitching', 'Muscular weakness', 'Nausea', 'Pyrexia', 'Syncope', 'Vomiting']",2,PFIZER\BIONTECH, 1076902,,,F,"COVID myelopathy; felt that her walking was off; feeling numbness of her right leg going up to her upper abdomen/ decreased sensation on her right side up to a mid-thoracic sensory level; COVID myelopathy/ leftsided cervical myelopathy; left arm pain and discomfort; left arm pain and discomfort; tingling sensation in her third, fourth, and fifth digits on her left hand; This is a spontaneous report from a non-contactable Pharmacist. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via unspecified route of administration on 21Jan2021 at unspecified age at single dose for COVID-19 immunisation. Patient was not pregnant at the time of events onset and at time of vaccination. Medical history included mitral valve atresia (MVA) and back pain. Patient has known allergies penicillin. The patient presented to office on 25Feb2021 with left arm pain and discomfort that started three weeks ago on 21Jan2021 and had resolved but left her with tingling sensation in her third, fourth, and fifth digits on her left hand, symptoms started three weeks ago, hours after getting her COVID-19 vaccine. About a week and a half ago in Feb2021 she began feeling numbness of her right leg going up to her upper abdomen with progressively worsening symptoms that had stabilized in the past several days. She also felt that her walking was off but cannot quite describe how or when it started. Exam notable for leftsided cervical myelopathy and decreased sensation on her right side up to a mid-thoracic sensory level. Of note she has a first cousin on her fathers side with multiple sclerosis and a more distant cousin on her mother's side with multiple sclerosis. Father with Parkinson's disease. COVID-19 biofire came back positive. In light of this, COVID myelopathy was (missing information). Adverse event COVID myelopathy start date was reported as 21Jan2021. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, hospitalization. It was unknown if there was COVID prior vaccination. COVID was tested post vaccination. Outcome of event left arm pain and discomfort was recovered with sequel, of the other events was unknown. No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on a temporal association, the causal association between the reported events and the suspect drug cannot be totally excluded. Patient's risk factor (family history of multiple sclerosis) can also be assessed as possibly contributory to the events. Case to be reassessed if follow-up information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/21/2021,01/21/2021,0.0,UNK,,,"Medical History/Concurrent Conditions: Back pain; Mitral valve atresia; Multiple sclerosis (a first cousin on her fathers side, a more distant cousin on her mother's side); Parkinson's disease (Father); Penicillin allergy",,,"['COVID-19', 'Gait disturbance', 'Hypoaesthesia', 'Investigation', 'Limb discomfort', 'Myelopathy', 'Pain in extremity', 'Paraesthesia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1076903,SC,77.0,F,"It was like a little twitch and then today it's like a jerk, it's big/Whole body is just jerking; It was like a little twitch and then today it's like a jerk, it's big/Whole body is just jerking; Felt like I was going to pass out; Felt unwell; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration (at the age of 77-years-old) on 15Feb2021 at a single dose for COVID-19 immunization. Medical history included Diabetes, asthma, High blood pressure, fibromyalgia, cane user, Neuropathy. Concomitant medication included pregabalin (LYRICA) and unspecified medications (""No, I am not because it's a very long list and I don't feel good, I am jerking and I just don't feel like doing that I am sorry.""). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Patient stated, ""My experience with the COVID-19, I had the injection on 15Feb, the second one and I went back and sat in my chair and I was okay. And then I got up to leave and I felt like I was going to pass out (15Feb2021). So, I sat down in the chair, my husband asked for the nurse and she came and she thought it was my diabetes which I also sort of felt that, but anyway I came home and I felt unwell (15Feb2021), that afternoon and then the next day, I would feel like that and then the next day I had improved but I started with this jerking and that has been going now since then but today it's more like (incomplete sentence). At first, it was like small and now they are getting big like a jerk. I called my family doctor yesterday and I talked with the nurse and she told me that I needed to be checked within 4 hours. So, I went to one of the in and out you know places, emergency places that you can go to and she took a lot of blood, and ones that came back were okay but the other results, she is not going to get until tomorrow, I have to go back. But have you have anybody else that has had this experience?"" The date when adverse event started was reported as ""Started out, it was like a little twitch on Wednesday night that would have been from Monday to Wednesday and then today it's just like a jerk, it's big. My whole body is just jerking. I did not feel well the afternoon I had it. But the next day, I thought I was better and that is when the twitch started."" The patient was experiencing event worse than ever. It's like a bigger jerk now. No treatment was received for the events. Lab test: ""They took 5 vials of blood yesterday when I went to that doctor, and I heard for some of it, but for the rest, I will have the results tomorrow and I just had my blood drawn on Thursday from my kidney doctor. So, I have blood drawn all the time."" The outcome of the event ""felt like I was going to pass out"" and felt unwell was recovering, and ""it was like a little twitch and then today it's like a jerk, it's big/whole body is just jerking"" was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/15/2021,0.0,UNK,LYRICA,,Medical History/Concurrent Conditions: Asthma (Verbatim: Asthma); Blood pressure high (Verbatim: High blood pressure); Cane user; Diabetes (Verbatim: Diabetes); Fibromyalgia (Verbatim: Fibromyalgia); Neuropathy (Verbatim: Neuropathy),,,"['Blood test', 'Dyskinesia', 'Malaise', 'Muscle twitching', 'Presyncope']",2,PFIZER\BIONTECH, 1076904,FL,68.0,M,"My sight started to go; started getting blurry and I can't see my phone to find number and it lasted about an hour my sight came back; sudden my sight started to go; blurry; ever since then my smell has been back; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: E9262), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included high blood pressure, over weight, lost my sense of smell, border line diabetic and a heart condition that is hereditary it has to deal with the elasticity of the vessels; all from unspecified date and unknown if ongoing. The patient was administered first dose of BNT162B2 (lot number: EH9899) on unspecified date for COVID-19 immunization and experienced the regular signs, a little bit of a headache, little dizziness in the morning, and cognitively was little not there for about an hour. Concomitant medication included lisinopril, metformin hydrochloride (ROBUSTIN) and vitamins. The patient stated, ""for the second shot the 2nd day I was at school letting kids out and all of a sudden my sight started to go. It started getting blurry and I got back into the building and my Principal said let's just call the doctors, I said I can't see my phone to get, find his number. They took care of that for me and it lasted about an hour and hour and half and my sight came back. That's was the only negative and the positive thing happened, I have lost my sense of smell 10 years ago from taking a prescription for high blood pressure I mean diabetes (unspecified medication). Within a month I lost complete smell of everything, for 10 years I have not been able to smell a thing. The day I lost my lost my sight for little while, that day on the way home I was driving pass a restaurant with my windows up and I could smell barbeque sauce, pass an Italian restaurant and I could smell Italian food, and ever since then my smell has been back. I don't know I am not complaining at all, I am just telling something that, the doctors says I haven't heard of that, so that I thought you should know."" The patient had bloodwork done with unknown results on unspecified date. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,LISINOPRIL; ROBUSTIN; VITAMINS NOS,,Medical History/Concurrent Conditions: Blood pressure high; Borderline diabetes; Heart disorder; Smell loss; Weight increase,,,"['Blindness', 'Blood test', 'Syncope', 'Therapeutic response unexpected', 'Vision blurred']",2,PFIZER\BIONTECH, 1076905,GA,37.0,F,"stools have been weird looking and smelly, like yeast; stools have been weird looking and smelly, like yeast; coffee (which is what has been tasting weird), tasted so gross; This is a spontaneous report received from a contactable other healthcare professional (patient herself). A 37-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3302, Expiry date: unknown), at 37 years of age via an unspecified route of administration on Left arm on 01Feb2021 at single dose for COVID-19 immunisation. Medical history was none. Concomitant medication included multivitamin (unspecified) and estradiol (ESTROGEN) as a supplement within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (Lot number: EJ1685, Expiry date: unknown) on 07Jan2021 at 09:30 AM on left arm for COVID-19 immunisation and experienced Exactly two weeks after the first vaccine I started smelling cigarette smoke and a sweet garlicky smell. Things tasted a little funny, but I mostly noticed it with coffee. Patient also had known allergies to clindamycin and Sulfa. The patient stated that, things tasted a little funny, but I mostly noticed it with coffee. I didn't think about the COVID shot, I just thought maybe I had a cold. Then exactly two weeks after the second, my coffee (which is what has been tasting weird), tasted so gross I had to throw it out in Feb2021. That's when I put it all together that it is probably from the vaccine. Then the more I research that sweet garlic is actually yeast I am smelling. Then I realized since all this has started by in Feb2021 stools have been weird looking and smelly, like yeast and sure enough I googled it and it looks similar. My co-worker is having a yeast infection also, but it is only in her mouth. The patient received treatment for the events with diflucan 150mg a 20-week cycle. The reporter considered the events as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events were assessed as non-serious by the reporter. The outcome of the events was reported as not recovered.; Sender's Comments: Based on temporal relationship, the causality between the suspect 'BNT162B2' and the reported 'stools have been weird looking and smelly, like yeast' cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,PUB,ESTROGEN,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Abnormal faeces', 'Fungal infection', 'Taste disorder']",2,PFIZER\BIONTECH, 1076906,CT,57.0,F,"Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for herself that the 57-year-old female patient received first dose of bnt162b2 (BNT162B2,COVID 19, brand: Pfizer BioNTech, lot number: EL3247), via an unspecified route of administration on 17Feb2021 15:45 on Left arm at single dose for covid-19 immunisation. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medication included rosuvastatin, zinc, ascorbic acid (VITAMINS C), ergocalciferol (VIT D), fish oil and Occuv. The patient experienced unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing (medically significant) on 20Feb2021 11:45AM with outcome of unknown, unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing on 20Feb2021 11:45 with outcome of unknown, unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing on 20Feb2021 11:45 with outcome of unknown. She is not pregnant. Facility type vaccine was workplace clinic. No other vaccine in four weeks. Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing. No treatment received. No Covid prior vaccination. No Covid tested post vaccination. Known allergies was none.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported auditory hallucinations cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/20/2021,3.0,WRK,ROSUVASTATIN; ZINC; VITAMINS C; VIT D; FISH OIL,,Medical History/Concurrent Conditions: High cholesterol,,,"['Hallucination, auditory', 'Hypoacusis']",1,PFIZER\BIONTECH, 1076909,FL,74.0,M,"Blood pressure would drop and then go back up; feeling passed; he is not thinking well; he is not talking as clear or loud; sick; Very hot, flushed; Everything started spinning; Headache; Mind not clear/It is like he is kind of in a fog. It is not clear; Not being as focused with is eyes; Breathing difficulty/breathing harder; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL9262 and expiry date: 21May2021) solution for injection, via an unspecified route of administration in arm on 17Feb2021 15:00 at a single dose for Covid-19 immunization. Medical history included muscle relaxer/pain therapy, accident at work (stated he taught college for many years. However, he was in (enforcement type) for the office of (County Name). He worked as an admin assistant for the state attorney. He was injured on the job because someone did not like him. He was injured real bad and taking these medications for pain. Concomitant medications included ongoing gabapentin (NEURONTIN) for pain, oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for pain, ongoing tizanidine (TIZANIDINE) as muscle relaxer/for pain, and unspecified medications for pain. The first dose was administered on 27Jan2021 (Lot Number: EL1283, Expiry Date: 30Apr2021), in Left arm. The patient reported breathing difficulty/breathing harder, mind not clear/it was like he was kind of in a fog. It was not clear, not being as focused with his eyes, all on 18Feb2021. On 19Feb2021, the patient reported his blood pressure would drop and then go back up, very hot, flushed, everything started spinning, and had headache and was sick. The patient reported feeling passed, he was not thinking well, he was not talking as clear or loud on an unspecified date. On Friday around 1'clock he got very hot, flushed. He took off his shirt. He was washing dishes. He needed to cool down a bit. He went to the bathroom to shave and brush his teeth. However, things were getting out of focus. He sat down on the toilet for about 3-4 minutes and then the feeling passed. He got back up and walked into the family room. He made it in there and had to sit down. All of a sudden he felt like everything was started to spin. Everything was really spinning. He was standing and had to sit down for a few minutes. While sitting he felt all of a sudden a super wave of feeling bad. He was sick. Everything was spinning. He could not stand it for another minute. The patient was hospitalized from 19Feb2021 to 21Feb2021 due to blood pressure would drop and then go back up. The fire department came and one of the things they did was check his blood pressure. Initially stated it was low and then it jumped up 20points when he stood up. They then threw him in the ambulance to take to the ER. He was going to the hospital because they thought he was having a stroke. He was seen by two different neurologist and other hospital doctors. The patient underwent lab tests and procedures which included blood pressure abnormal: it was low and then it jumped up 20points (Initially stated it was low and then it jumped up 20points when he stood up), blood pressure abnormal: believes it was like 140 was the high (he was unable to provide a true blood pressure reading at the time event occurred. Stated he was messed up in the head. He believes it was like 140 was the high. His was usually lower than that to begin with. Then it would go to 110. It would bounce from 110 to 140. It would change from sitting to standing), chest X-ray and electrocardiogram: test came back negative (He was in the ER and had a Chest -X Ray. He had an electrocardiogram, EKG, he had a scan that was dry without contrast and second one with contrast/iodine. He had an MRI of the brain to check for brain bleed. They thought he was in the process of having a stroke. They could not find anything. He had two CTs. Test came back negative. Neurologist determined it was not a stroke. Decided it must be inner ear situation), computerised tomogram: test came back negative (he was in the ER and had a Chest -X Ray. He had an electrocardiogram , EKG, he had a scan that was dry without contrast and second one with contrast/iodine. He had an MRI of the brain to check for brain bleed. They thought he was in the process of having a stroke. They could not find anything. He had two CTs. Test came back negative. Neurologist determined it was not a stroke. Decided it must be inner ear situation); test done on his heart, MRI of the brain, and two different scans: everything was negative (he had all kinds of test done on his heart, two different scans, MRI of the brain to see if had a brain bleed all that stuff. He was in the hospital for three days. Yesterday he was sent home. They found nothing wrong. Everything was negative. Therefore, he was sent home. Outcome of the event Blood pressure would drop and then go back up, Breathing difficulty/breathing harder, Mind not clear/It is like he is kind of in a fog/It was not clear was recovering; everything started spinning was recovered 20Feb2021; not being as focused with his eyes, feeling passed, he was not thinking well, he was not talking as clear or loud, and sick was unknown; headache was not recovered. No follow-up activities are needed. No further information is expected. Information about lot/batch number has been obtained.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/17/2021,02/18/2021,1.0,UNK,NEURONTIN; PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]; TIZANIDINE,,Medical History/Concurrent Conditions: Injury at work; Muscle relaxant therapy; Pain,,,"['Blood pressure abnormal', 'Blood pressure fluctuation', 'Bradyphrenia', 'Chest X-ray', 'Computerised tomogram', 'Dyspnoea', 'Electrocardiogram', 'Feeling abnormal', 'Headache', 'Hot flush', 'Illness', 'Laboratory test', 'Loss of consciousness', 'Magnetic resonance imaging head', 'Scan', 'Speech disorder', 'Vertigo', 'Vision blurred']",2,PFIZER\BIONTECH, 1076910,,,F,"anaphylactic reaction from Covid vaccine; nausea; This is a spontaneous report from a contactable Other Health Professional (HCP). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date unknown) on an unspecified date (unknown age at the time of vaccination), at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received pegvisomant (SOMAVERT) and experienced nausea. Patient reported the following: pegvisomant 30 mg daily; five missed does due to anaphylactic reaction from Covid vaccine and missed doses (amount missed or dates unknown) due to nausea. MD aware. The outcome of the event was unknown. Information on Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available and the known product safety profile, a causal association between the reported event 'anaphylactic reaction' and the suspect product BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Anaphylactic reaction', 'Nausea']",UNK,PFIZER\BIONTECH, 1076911,CA,101.0,F,"passed away shortly after her vaccine; started dealing with signs that are common with a stroke; developed swelling in her arms; This is a spontaneous report from a contactable consumer report for grandmother. A 101-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EM9809) via an unspecified route of administration in left arm on 08Feb2021 04:30 AM at single dose for covid-19 immunisation. Medical history included elderly. No covid prior vaccination. No other vaccine in four weeks; No other medications in two weeks. On 12Feb2021 12:00 AM, patient passed away shortly after her vaccine. She started dealing with signs that are common with a stroke. Event considered Life threatening illness (immediate risk of death from the event). She also developed swelling in her arms. No treatment received, patient not recovered from stroke and swelling arm. The patient died on 12Feb2021. No covid tested post vaccination. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: passed away shortly after her vaccine",Yes,02/12/2021,Yes,Not Reported,,Not Reported,N,02/08/2021,02/12/2021,4.0,UNK,,,Medical History/Concurrent Conditions: Elderly,,,"['Cerebrovascular accident', 'Death', 'Peripheral swelling']",1,PFIZER\BIONTECH, 1076912,,,U,died from COVID after receiving the two doses of the vaccine; COVID; This is a spontaneous report from a contactable consumer report for a friend. A patient of unspecified age and gender received first dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) both via an unspecified route of administration on unspecified dates at single doses for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer mentioned her friend died from COVID after receiving the two doses of the vaccine. The patient died on an unspecified date. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died from COVID after receiving the two doses of the vaccine,Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective']",2,PFIZER\BIONTECH, 1076913,,35.0,M,"Pain in arm/sore arm; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from another company (MFR. Control No.: 20K-163-3447228-00). A 35-year-old male patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: e10142, expiry date: Mar2021), intramuscular on 11Jan2021 at single dose for covid-19 immunisation, adalimumab (HUMIRA), subcutaneous from Sep2019 to an unspecified date, 10Jun2020 to Jun2020 and 24Jun2020 and ongoing at 40 mg (40 mg, 1 in 1 wk) for Moderate to Severe Hidradenitis Suppurativa. Medical history included hyperlipidaemia, high cholesterol, depression, hypothyroidism, sleep apnea from an unknown date and unknown if ongoing, Down syndrome from 31Jan1985 to an unknown date, pneumonia from 1986 to 1986, open heart surgery in May1988, May1994 and Jul2012, acute respiratory distress syndrome from 08Dec2002 to 04Apr2003, aspiration pneumonia from 08Apr2003 to 15Apr2003 and clinical trial participant in 11Jan2021. Concomitant medication included atorvastatin at 20 mg for high cholesterol and hyperlipidemia, fluoxetine at 40 mg for depression, levothyroxine at 0.75 mg, 1 in 2 D for hypothyroidism and sleep apnea, colecalciferol (VITAMIN D3 1000) for supplement. The patient previously took Reglan and experienced vomiting, confusion and disorientation, Percocet and experienced vomiting and disorientation, Toradol and Zofran and experienced vomiting, confusion and disorientation; Humira for moderate to severe hidradenitis suppurativa in Sep2019 and experienced abdominal hernia on Nov2019 which resolved in 19Jun2020 and hidradenitis suppurativa breakout underarm and in groin area/hidradenitis suppurativa flare in Sep2019 which resolved on an unspecified date. The patient experienced pain in arm/sore arm on 12Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on an unspecified date, ultrasound abdomen: unknown results (Abdominal Hernia that needed surgical repair) on 11Jan2020. The action taken in response to the event for adalimumab was dose not changed. The patient recovered from the event on 13Jan2021. The reporter assessed the event as probable to the drug and vaccine.; Sender's Comments: There is a reasonable possibility that the event pain in arm/sore arm was related to BNT162b2 based on known drug safety profile and close temporal relationship.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/11/2021,01/12/2021,1.0,UNK,ATORVASTATIN; FLUOXETINE; LEVOTHYROXINE; VITAMIN D3 1000,,Medical History/Concurrent Conditions: Acute respiratory distress syndrome; Aspiration pneumonia; Clinical trial participant; Depression; Down's syndrome; High cholesterol; Hyperlipidemia; Hypothyroidism; Open heart surgery; Pneumonia; Sleep apnea,,,"['Pain in extremity', 'SARS-CoV-2 test', 'Ultrasound abdomen']",1,PFIZER\BIONTECH,OT 1076914,WI,,F,"brain dead; aneurysm/brain aneurysm; hemorrhage stroke in her brain stem; Subarachnoid hemorrhage; sick and ""breaking out""; This is a spontaneous report from a non-contactable consumer. This consumer reported for a 28-year-old female patient received the second dose of bnt162b2 (PFIZER MRNA COVID VACCINE), via an unspecified route of administration in Feb2021 at single dose for Covid-19 immunisation. The medical history and concomitant medications were not reported. The patient previously received the first dose of BNT 162B2 for Covid-19 immunisation. The patient had aneurysm- brain dead on 07Feb2021, five days after second experimental Pfizer mRNA COVID Injection. She had suffered a brain aneurysm on 07Feb2021. The patient had a hemorrhage stroke in her brain stem on 07Feb2021. She had been on life support ever since. After all of the tests run, and the MRI results, the Doctors determined that there is no possibility of recovery and eventually her body will shut down. The patient had been sick and ""breaking out"" in Feb2021 from the COVID vaccine. She react to a pinch, but that's it, eyes were still not open. Subarachnoid hemorrhage was what happened in Feb2021. She was an organ donor, so her body was being kept alive until they find suitable recipients for her organs. The patient died on 07Feb2021. The outcome of brain aneurysm and brain dead was fatal. The outcome of other events was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: aneurysm/brain aneurysm; Brain dead",Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,UNK,,,,,,"['Brain death', 'Haemorrhagic stroke', 'Illness', 'Intracranial aneurysm', 'Investigation', 'Magnetic resonance imaging', 'Subarachnoid haemorrhage']",2,PFIZER\BIONTECH, 1076915,,,F,"(name) is now dead 2 days after receiving a COVID mRN shot; This is a spontaneous report from a non-contactable other non HCP. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient is now dead 2 days after receiving a Covid mrn (as reported) shot in Jan2021. She died two days later, according to her mother. 28 year old daughter took the vaccine on a Tuesday (on 19Jan2021) and was dead by Thursday (on 21Jan2021). Outcome of event was fatal. Autopsy shows no other red flags (as reported). The reporter has assured us he will get to the bottom of this vaccine crap. Anything attached should be red flag (as reported). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: (name) is now dead 2 days after receiving a COVID mRN shot",Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/21/2021,2.0,UNK,,,,,,['Death'],UNK,PFIZER\BIONTECH, 1076916,,31.0,M,"I was suffering from paralysis and numbness on the left side of my face. I went to the ER and was diagnosed with Bell's Palsy; This is a spontaneous report from a non-contactable consumer (the patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) via an unspecified route of administration in left arm on 21Feb2021 11:30 a.m. at age of 31-year-old, at single dose for COVID-19 immunisation. The patient had history of frequent ear infections. Concomitant medication included fluticasone which was taken within 2 weeks of vaccination for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient reported when he woke up the next day after receiving the vaccine (22Feb2021), he found that he was suffering from paralysis and numbness on the left side of his face. He went to the emergency room (ER) and was diagnosed with Bell's Palsy. He had been experiencing some minor pain in his left ear beginning two days before he received the vaccine (i.e., three days before onset of facial paralysis), and this ear pain had continued as he continue to experience the palsy. Since visiting the ER, he had also seen a neurologist. The doctors he had seen do not necessarily think that the palsy resulted from receiving the vaccine. The onset date of the event ""I was suffering from paralysis and numbness on the left side of my face. I went to the ER and was diagnosed with bell's palsy"" was reported as 22Feb2021 09:00 a.m. The event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The event was non-serious (the event did not result in death, not life threatening, not caused/prolonged hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect). Oral steroid and antiviral drugs, eye ointment was received to treat the event. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/22/2021,1.0,WRK,FLUTICASONE,,Medical History/Concurrent Conditions: Ear infection,,,"[""Bell's palsy""]",1,PFIZER\BIONTECH, 1076917,PA,,F,"one died after the vaccine; This is a spontaneous report from a Pfizer-sponsored program. This contactable consumer reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter reported 3 females died post vaccination with the Pfizer-BioNTech COVID-19 vaccine. She explained one died after the vaccine on an unspecified date. She explained she had no additional details on the adverse event. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: one died after the vaccine",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],1,PFIZER\BIONTECH, 1076918,PA,,F,chest pain; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient in her 50s received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drug was unknown. The patient died after experiencing chest pain for 2 weeks post vaccination. The outcome of event was fatal. It was unknown if autopsy done or not. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Chest pain,Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Chest pain'],1,PFIZER\BIONTECH, 1076919,PA,,F,"died of an heart after the vaccine/Heart attack; This is a spontaneous report from a contactable consumer received from a Pfizer-sponsored program. This consumer reported similar events for 3 patients. This report is the 1st of 3. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced heart attack on an unspecified date. The patient died of an heart attack after the vaccine on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died of an heart after the vaccine/Heart attack",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Myocardial infarction'],UNK,PFIZER\BIONTECH, 1076920,CA,45.0,F,"chest pain; Shortness of breath; This is a spontaneous report from a contactable other health professional (patient herself). A 45-year-old female patient (non-pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 10Jan2021 (at the age of 45-years-old) in left arm at single dose for covid-19 immunisation. The patient medical history was not reported. Patient had no chronic illnesses and no allergies. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Other medications in two weeks was none. The patient previously took the first dose of bnt162b2 (Pfizer) on 21Dec2021 12:00 PM via intramuscular in left arm for COVID-19 immunization. The patient experienced chest pain and shortness of breath on 15Feb2021 01:00 (as reported). Clinical course: She took her second vaccine on 10Jan2021. Two weeks after the vaccine she was admitted to the hospital with chest pain and shortness of breath x2, one on 19Feb2021 (as reported) and the second time was 24Feb2021. On an unspecified date, all the blood works and CT (computerised tomogram) scan came back negative. She was a healthy individual until she took this vaccine. She also did Echocardiogram which came back negative. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). No treatment was received for events. Outcome of events were unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently provided, chest pain and shortness of breath occurred 2 weeks following the second vaccine are more likely associated with coincidental medical conditions unlikely related to the vaccine use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,,Not Reported,U,01/10/2021,02/15/2021,36.0,PVT,,,,,,"['Blood test', 'Chest pain', 'Computerised tomogram', 'Dyspnoea', 'Echocardiogram']",2,PFIZER\BIONTECH, 1076933,OH,89.0,M,"2/17/21 Pt w/fever, SOB and diarrhea. Positive household exposure to COVID. + for SARS-CoV-2. Was given fluids and no hypoxemia. Discharged to home and set up with monoclonal AB infusion 2/18/21 In am pt received bamlanivumab w/o issue 2/18/21 several hours later pt returned to ED w/fever to 103.1, tachypnea and hypoxemia. Pt was started on steroid and he had rapid improvement. He weaned off oxygen on 2/19. He was discharged 2/20.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/13/2021,02/18/2021,5.0,PVT,apixaban 5mg BID atorvastatin 40mg QD finasteride 5mg QD furosemide 40mg QD latanoprost one gtt OU QHS lisinopril 40mg QD KCl 20mEq QD,none,history of renal cell CA s/p left nephrectomy 2008 CHF GERD glaucoma HTN CKD stage 3 peripheral neuropathy mitral regurgitation BPH w/obstruction heart block vascular dementia s/p AICD chronic diarrhea,,Opioids-intolerance pseudoephedrine-anxiety,"['Atelectasis', 'Blood bicarbonate normal', 'Blood chloride normal', 'Blood creatinine increased', 'Blood glucose normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea increased', 'Brain natriuretic peptide increased', 'COVID-19', 'Cardiomegaly', 'Chest X-ray abnormal', 'Condition aggravated', 'Diarrhoea', 'Dyspnoea', 'Exposure to SARS-CoV-2', 'Haematocrit decreased', 'Haemoglobin decreased', 'Hypoxia', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Lung opacity', 'Platelet count decreased', 'Pneumonia viral', 'Pyrexia', 'SARS-CoV-2 test positive', 'Tachypnoea', 'White blood cell count normal']",2,PFIZER\BIONTECH,IM 1076949,OR,22.0,F,"Patient admitted on 2/21/21 and died in hospital on 2/22/2021. Patient had a significant, lifelong underlying medical condition.",Yes,02/22/2021,Not Reported,Yes,2.0,Not Reported,,01/29/2021,02/22/2021,24.0,PVT,,,,,,['Death'],2,PFIZER\BIONTECH,IM 1076954,PA,27.0,M,"Patient is a 27 year old male with no significant medical history presents to MC on 2/6 from Urgent Care for further evaluation of chest pain. He states that he woke up at 5:30am with abrupt onset of chest pain with present like quality in the middle of the chest. It was non-radiating with associated nausea, small amount of emesis, and dyspnea. His pain lasted for about 15 minutes and he started experiencing it again after half an hour with numbness and tingling of his bilateral distal digits and diaphoresis. He decided to seek evaluation at local Urgent Care around 7:30am. States that he was immediately send here through ambulance due to findings of EKG changes. He was given aspirin and nitroglycerin with some alleviation of pain. Currently, he feels little better although continues to have chest pressure substernally every 45 minutes lasting 5-10 minutes. His dyspnea is resolved. He does not have pleuritic chest pain, fever, chills, nausea, vomiting, abdominal pain, diarrhea, leg swelling, rash. Additionally, he has been in normal state of health until this 2/2/21 when he received second dose of COVID-19 (Pfizer) vaccine. He had extreme fatigue with left arm soreness. He reports no sick contacts, recent illness, or travel. MRI cardiac done 2/9/21 with assessment reveals Infero-lateral myocarditis. Patient remained hemodynamically stable and was discharged with ibuprofen taper for 10 days, c/w colchicine 0.6 mg QD x 3 months and pantoprazole 40 mg QD",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,02/03/2021,02/06/2021,3.0,PVT,ibuprofen as needed for pain,,None,,,"['Adenovirus test', 'Antinuclear antibody negative', 'COVID-19', 'Cardiac imaging procedure abnormal', 'Chest discomfort', 'Chest pain', 'Chlamydia test negative', 'Coxsackie virus test', 'Cytomegalovirus test negative', 'Dyspnoea', 'Electrocardiogram change', 'Epstein-Barr virus test negative', 'Fatigue', 'Herpes simplex test negative', 'Herpes virus test', 'Hyperhidrosis', 'Hypoaesthesia', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Legionella test', 'Myocarditis', 'Nausea', 'Pain in extremity', 'Paraesthesia', 'Parvovirus B19 test', 'Polymerase chain reaction', 'Respiratory syncytial virus test negative', 'Rheumatoid factor', 'SARS-CoV-2 antibody test positive', 'SARS-CoV-2 test negative', 'Vomiting']",UNK,PFIZER\BIONTECH, 1076958,MD,60.0,F,Headache. Hives started around 4:00PM on Friday March52021,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/05/2021,1.0,WRK,Montelukast 10mg Desloratadine 5mg Escitalopram 20mg Valtartan/ hydro 160mg/ 12.5mg Atorvastatin 40mg,Pinched nerve in neck,Diabetes 2 Blood pressure,,None,"['Headache', 'Urticaria']",1,JANSSEN,SYR 1076967,ME,63.0,F,"Achy, fever of 100, chills fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/05/2021,1.0,PUB,"Calcium, magnesium, vitamin d3,",None,None,,None aware of,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1076972,MA,78.0,M,Monday morning I found my father lying on couch trying to tell me he couldn?t walk. His speech was slurred he fell and was unable to walk good his body was pulling to one side. His left arm was numb . I called ambulance he was taken to hospital diagnosed with a stroke. Now in rehab,Not Reported,,Yes,Yes,3.0,Yes,N,02/28/2021,03/01/2021,1.0,OTH,Atenolol and Atorvastatin,,High blood pressure normal at doctor appt week prior,,,"['Blood test', 'Cerebrovascular accident', 'Computerised tomogram', 'Dysarthria', 'Echocardiogram', 'Fall', 'Gait disturbance', 'Hypoaesthesia', 'Magnetic resonance imaging', 'Posture abnormal', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,SYR 1077008,CO,89.0,F,"Per patient's daughter the patient had severe flu like symptoms, shaking, extreme pain in wrists/fingers/feet. Patient collapsed at home and pronounced dead at scene.",Yes,03/04/2021,Not Reported,Not Reported,,Not Reported,N,02/26/2021,02/26/2021,0.0,MIL,"Celebrex 100mg BID Synthroid 75mcg daily Moxifloxacin 0.5% eye drops Omeprazole 20mg Prilac OTC: Multivitamin (Womens), Vitamin D, Vitamin E",,"Hypertension, Hyperlipidemia, Gout, GERD, Hypothyroidism, Osteoarthritis, Chronic Kidney Disease, Esophageal Strictures s/p dilation",,Ramipril (Altace) Simvastatin (Zocor),"['Arthralgia', 'Death', 'Influenza like illness', 'Pain in extremity', 'Syncope', 'Tremor']",2,MODERNA,IM 1077013,OK,23.0,F,"Fever, chills, stomach pain, muscle pain, headache, nausea, soft stool, fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/04/2021,03/05/2021,1.0,PHM,"Birth control, cyclonbenzaprine 5mg",,Iron deficiency,"Fever, headache, muscle pain, stomach pain, soft stool, nausea, chills.",,"['Abdominal pain upper', 'Chills', 'Faeces soft', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",1,JANSSEN,SYR 1077014,AK,74.0,M,Death,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,,02/05/2021,02/01/2021,,PVT,,.,Multiple including end stage/O2 dependent COPD,,,['Death'],1,MODERNA,IM 1077021,OR,77.0,M,Patient passed away three days after receiving the vaccine.,Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/09/2021,3.0,PVT,"IBU, Norco, Albuterol, Amlodipine, Atorvastatin, Asprin, Flomac, Garlic Oil, Lexapro, Singulair, Symbicort","Breathing Problem, Chest pain, Emphysema, Heart Attack/Cough, Lung Disease, Thyroid Disease",none,,None,['Death'],1,MODERNA,IM 1077053,CA,77.0,M,"Patient received the first shot on 2/17/21. Nothing seemed unusual during the following days; no complaining of soreness or anything. He hadn't introduce any new medicine or food into his routine. On the morning of 2/21/21, he woke up around 5 AM as usual. He spoke with his wife for a bit. Around 7:00 AM, he started having trouble breathing. He asked for help from family members. 911 was called. EMT's preformed heart compressions for about 45 minutes before pronouncing patient deceased. During EMT's initial encounter, EMT's struggled getting a tube down patient's throat due to his tongue being swallon",Yes,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/21/2021,4.0,PVT,"Hydralazine, Ipratropium, Alvesco, Losartan, Clonidine Humulin",,"Anemia, Osteopenia, Diabetes Type 2, Emphysema,",,Metoprolol,"['Death', 'Dyspnoea', 'Resuscitation', 'Swollen tongue']",1,PFIZER\BIONTECH,SYR 1077055,MA,27.0,M,"Fever onset (100F) along with chills uncontrollable shivering and teeth chattering around 8 PM. Around 5 Am, fever had hit 103F and body temperature (measured by an Oura ring) recorded average body temperature increase of +5.6F while sleeping compared to baseline. Fever remained intermittently throughout the next day, as well as headache, sore throat, chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/04/2021,03/04/2021,0.0,PVT,,minor sore throat,Discoid lupus,,,"['Chills', 'Headache', 'Oropharyngeal pain', 'Pyrexia']",1,JANSSEN,SYR 1077079,CA,77.0,F,"Patient was alert and oriented with no signs or symptoms of sickness prior to immunization for 2nd dose of Pfizer COVID19 vaccine. Temperature 98.7. Patient under hospice care and DNR status for wound care (coccyx). Patient has no recollection of first dose, but no adverse reactions to first dose per her caregivers. Patient did not appear to have any adverse reactions to the vaccine after the 15 minute observation period. About 1 hr after vaccine administration, patient was reported deceased. No signs of swelling or allergic reaction at site of injection.",Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,SEN,"Aspirin, Tylenol, Sennakot, Amlodipine",Coccyx wound (hospice care),Diabetes Type 2,,Iodine (Skin Reaction),['Death'],2,PFIZER\BIONTECH,IM 1077148,TX,64.0,M,It was reported to us that at @1822 the patient sustained a Seizure at home. EMS was called and arrived to initiate CPR. CPR was performed but the patient was declared deceased by EMS at his home.,Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,OTH,Unknown,Unknown,Unknown,,Unknown,"['Death', 'Resuscitation', 'Seizure']",2,PFIZER\BIONTECH,IM 1077190,FL,45.0,M,"Took vaccine in left arm late afternoon on Friday 2/12/21. The initial symptoms were only very painful muscle pain on the injected arm, and some mild body ache and mild chills for 2-3 days but nothing major. On Monday 2/15/21 was feeling very well and had nice workout in the morning , feeling energetic . However, in the morning on Tuesday 2/16/21, I started having very strong abdominal cramps, feeling bloated, nausea, that was lasting for several hours and increasing in pain . After 5 hours of pain, I asked my wife to take me to Hospital. There I was diagnosed with Appendicitis after a Cat Scan. My appendix was inflamed and I had to go thru surgery that same day .",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/12/2021,02/16/2021,4.0,PVT,"Testosterone , Gonadotropin, Ipamorelin",No,No,,No,"['Abdominal distension', 'Abdominal pain', 'Appendicectomy', 'Appendicitis', 'Blood test abnormal', 'Chills', 'Computerised tomogram abnormal', 'Myalgia', 'Nausea', 'Pain']",1,MODERNA,IM 1077194,AZ,82.0,F,Six days after her first dose she had a TIA which was confirmed at the hospital.,Not Reported,,Yes,Yes,11.0,Yes,U,02/13/2021,02/19/2021,6.0,OTH,"Meloxicam, Tylenol,Gabapentin",,"Arthritis, Stenosis",,None,['Transient ischaemic attack'],1,PFIZER\BIONTECH,IM 1077226,LA,59.0,F,"Slight headache mid afternoon. Chills about 6pm. Fever of 100.8 around 7:30pm. Unsure whet OTC med to take. At 9pm, fever 101.6. Took ibuprofen with PowerAde around 9:15pm. What should I take and how much?",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/05/2021,03/05/2021,0.0,OTH,"Supplements- Vitamin C, elderberry gummy, Nature?s Bounty hair, skin & nails, acidophilus probiotic,and Rx- metformin 500 mg 12 hours before.",None,Medication for diabetes 2 based on diet and exercise,,None.,"['Chills', 'Headache', 'Pyrexia']",1,JANSSEN,SYR 1077227,GA,84.0,F,nausea and diahhrea,Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,N,02/24/2021,02/26/2021,2.0,UNK,,,"CAD, CHF, Kidney Failure.",,,"['Diarrhoea', 'Nausea']",UNK,PFIZER\BIONTECH, 1077228,MA,53.0,F,"Injection 1: 01/30/2021 abdominal pain upper right side under rib cage. Lasted about 3 hours 02/01/2021 more accute symptoms of right abdominal pain 2 instances 1 lasting 3-4 hours and one lasting over 6 hours. Injection 2: 02/25/2021 acute abdominal pain lasting over six hours. 03/01/2021 worst abdominal pain ever, transported to Medical Center Emergency Room. Diagnosis: inflamed gallbladder 03/04/2021 gallbladder removed",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/27/2021,01/29/2021,2.0,OTH,Venlafaxine Busbar Prazosin Oxybutynin Pro-Air Inhaler,None,Depression Anxiety PTSD Asthma,"Flu, Typhoid, Yellow Fever 1986, age 19",Gabapentin Oral Sulfa Antibiotics Duck Goose Turkey Flu vaccine Yellow Fever Vaccine Typhoid Vaccine,"['Abdominal pain upper', 'Cholecystectomy', 'Cholecystitis', 'Full blood count', 'Magnetic resonance imaging', 'Metabolic function test', 'Scan with contrast']",2,MODERNA,SYR 1077236,IL,94.0,F,Family states patient had been coughing and was weak after the vaccine. Patient walked to the bathroom and then fell striking her head found in PEA with agonal breathing. Despite aggressive CPR medications patient remained in asystole. Unknow if Moderna or Phifzer,Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/01/2021,03/01/2021,0.0,PVT,"""sleeping pill""",cough after vaccine and weakness,none,,unknown,"['Agonal respiration', 'Asthenia', 'Cardiac arrest', 'Cough', 'Fall', 'Head injury', 'Pulseless electrical activity', 'Resuscitation']",UNK,MODERNA, 1077239,AZ,24.0,M,"Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Patient recovered after surpine positing for 15 minutes and water",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,PHM,,,,,,"['Asthenia', 'Dizziness', 'Nausea', 'Syncope', 'Tremor', 'Unresponsive to stimuli']",1,JANSSEN,IM 1077244,VA,69.0,F,2 seizure back 2 back extreme arm pain,Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/20/2021,03/02/2021,10.0,PVT,Eye drops for eye pressure,None,None,,None,"['Pain in extremity', 'Seizure']",UNK,MODERNA, 1077251,MN,67.0,F,"Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/01/2021,03/02/2021,1.0,PHM,,,,,,"['Chills', 'Confusional state', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain', 'Lethargy', 'Nausea', 'Pain', 'Pyrexia', 'Tremor']",1,MODERNA,IM 1077253,NV,31.0,F,"About 6 hours after shot, began having chills. Chills lasted 12 plus hours. Fever followed chills. Couldn?t get warm enough but fever was high. Mouth thermometer indicated fever of 101.5* for several hours (24 plus); non oral thermometer indicate parts of body were 105.0*. Despite chills. Terrible headache and aches so bad I couldn?t sleep. Finally took some Advil PM so I could finally sleep. Next day, still have fever, aches, and headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/04/2021,0.0,PUB,,None,Fibromyalgia; migraines.,Recent Tdap shot,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1077254,CA,61.0,F,"Site: Itching at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch Generalized-Mild",Not Reported,,Not Reported,Yes,,Not Reported,U,03/04/2021,03/04/2021,0.0,PHM,,,,,,"['Dysphagia', 'Dyspnoea', 'Injection site pruritus', 'Pruritus', 'Throat tightness']",1,MODERNA,IM 1077266,MN,76.0,M,"ITP, platelet count 1 on 3/5/21 (has petechia, purpura in mouth, and right sided nose bleed). Admitted for steroid therapy.",Not Reported,,Yes,Yes,,Not Reported,N,03/01/2021,03/05/2021,4.0,PVT,"Aspirin, valsartan, atorvastatin, nitroglycerin sublingual prn",None,"CABG, HTN, hyperlipidemia, lung cancer, thoracotomy R lung w/wedge resection",,None,"['Epistaxis', 'Immune thrombocytopenia', 'Oral purpura', 'Petechiae', 'Platelet count decreased']",1,MODERNA,IM 1077275,FL,84.0,F,At about 11:00 am which was about 22 hours after receiving 2nd dose of Moderna patient exhibited difficulty breathing and soon breathing became more difficult to point where her shoulders were lifting to breathe. At 6:45 pm she passed away.,Yes,02/16/2021,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/16/2021,1.0,PUB,"Xanax, Levothyroxin, Seroquel","Alzheimer?s,",Alzheimer?s,,Statins,"['Death', 'Dyspnoea']",UNK,MODERNA, 1077290,NM,58.0,F,"Per Dr's admission H&P: "" HISTORY OF PRESENT ILLNESS 58 yo F presenting via PH EMS with complaints for fever and SOB and weakness and dizziness. was brought in on 3L NC with Spo2 around 93 but was down to 84% on RA. initialy BG was 79, s/p 15g oral glucose with BG up to the 90s. speaking with patient she will awake to noise and starts her story and hen will stop. starts off by saying she had her covid shot on wednesday. patient denies any pain. speaking with her daughter over the phone, reports she had her COVID shot on wednesday and started to have HA and get weak and sob. reports she believes this is a reaction to the covid vaccination because the same thing happened to her when she received the singles shot a couple of months ago. reports she had a mild reaction when she received the first covid shot which was feeing tired and arm pain. """,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,03/03/2021,03/05/2021,2.0,PVT,Issue Date Status Last Fill Active Outpatient Medications Refills Expiration ========================================================================= 1) ACCU-CHEK,,"Chronic Problems: 1)Diabetes mellitus type 2 - 2)Hypothyroidism - 3)Asthma - 4)Benign essential hypertension - 5)Hyperlipidemia - 6)Female stress incontinence - 7)Tear film insufficiency, Bilateral - 8)Adhesions of iris - OU 9)Obstructive sleep apnea syndrome - 10)Chronic low back pain - 11)Gastroesophageal reflux disease - 12)Chorioretinal scar of posterior pole of eye - OU 13)Posterior synechiae - OU 14)Posterior vitreous detachment - OU 15)Diabetes mellitus type 2 without retinopathy - 16)Chronic migraine without aura - 17)Myopia, Bilateral -",,Allergies: PROZAC,"['Alanine aminotransferase normal', 'Anion gap', 'Aspartate aminotransferase normal', 'Asthenia', 'Bacterial test', 'Basophil count normal', 'Basophil percentage decreased', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bilirubin increased', 'Blood calcium decreased', 'Blood chloride decreased', 'Blood creatinine normal', 'Blood glucose normal', 'Blood ketone body absent', 'Blood lactic acid', 'Blood magnesium normal', 'Blood osmolarity decreased', 'Blood phosphorus decreased', 'Blood potassium normal', 'Blood sodium decreased', 'Blood thyroid stimulating hormone', 'Blood urea decreased', 'Blood urine absent', 'C-reactive protein increased', 'Carbon dioxide normal', 'Chest X-ray normal', 'Chromaturia', 'Computerised tomogram head normal', 'Confusional state', 'Crystal urine', 'Dizziness', 'Dyspnoea', 'Eosinophil count decreased', 'Eosinophil percentage decreased', 'Glomerular filtration rate normal', 'Glucose urine absent', 'Haematocrit normal', 'Haemoglobin normal', 'Headache', 'Immature granulocyte count increased', 'Influenza A virus test negative', 'Influenza B virus test', 'Influenza virus test negative', 'Lymphocyte count decreased', 'Lymphocyte percentage decreased', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Mean platelet volume normal', 'Monocyte count normal', 'Monocyte percentage decreased', 'Neutrophil count increased', 'Neutrophil percentage increased', 'Nitrite urine absent', 'Platelet count normal', 'Protein total normal', 'Protein urine absent', 'Pyrexia', 'Red blood cell count normal', 'Red blood cells urine positive', 'Red cell distribution width normal', 'Respiratory syncytial virus test negative', 'SARS-CoV-2 test negative', 'Specific gravity urine normal', 'Troponin normal', 'Urinary casts', 'Urinary sediment present', 'Urine analysis abnormal', 'Urine bilirubin decreased', 'Urine ketone body present', 'Urine leukocyte esterase', 'Urobilinogen urine decreased', 'White blood cell count increased', 'White blood cells urine positive', 'pH urine normal']",2,MODERNA,IM 1077297,GA,91.0,M,He collapsed and went into cardiac arrest,Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,PVT,Plavix. Digoxin. Lasix. Spironolactone. Coq10. Zinc. Vit c. Vitamin d. Multiple vit.,Stable CASHD. stable COPD. No acute illnesses,CASHD. COPD,,None,"['Cardiac arrest', 'Resuscitation', 'Syncope']",1,PFIZER\BIONTECH,IM 1080424,,88.0,M,"Narrative: above in section ""Other relevant history""",Yes,02/13/2021,Not Reported,Yes,,Not Reported,N,01/12/2021,01/13/2021,1.0,OTH,,,,,,"['COVID-19', 'Death', 'SARS-CoV-2 test positive', 'White blood cell count increased']",1,MODERNA,IM 1080425,,74.0,M,"Narrative: Patient with h/o ESRD on HD MWF, HTN presented to ER on 2/20/21 with worsening dyspnea and GI symptoms; tested positive for COVID-19. Patient had received first COVID vaccination approx. 9 days prior. Patient admitted to ICU for treatment of COVID+ PNA. During admission, patient often could not tolerate removal of fluid during HD d/t tachycardia. He received dexamethasone, convalescent plasma for COVID. Patient underwent TTE which was notable for septal wall motion abnormalities and grossly reduced EF. Admission also c/b acute liver injury, possible cholecystitis, thrombocytopenia, SVT, encephalopathy. Patient then developed progressive shock and hemodynamic instability on 3/2 and passed away on 3/2/21.",Yes,03/02/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/20/2021,9.0,OTH,,,,,,"['Atrial septal defect', 'COVID-19', 'COVID-19 pneumonia', 'Convalescent plasma transfusion', 'Death', 'Dyspnoea', 'Echocardiogram', 'Ejection fraction decreased', 'Encephalopathy', 'Gastrointestinal disorder', 'Haemodynamic instability', 'Intensive care', 'Liver injury', 'SARS-CoV-2 test positive', 'Shock', 'Supraventricular tachycardia', 'Tachycardia', 'Thrombocytopenia']",UNK,MODERNA,IM 1080427,,88.0,M,"Narrative: above in section ""Other relevant history""",Yes,02/13/2021,Not Reported,Yes,,Not Reported,N,01/12/2021,01/13/2021,1.0,OTH,,,,,,"['COVID-19', 'Death', 'SARS-CoV-2 test positive', 'White blood cell count increased']",1,MODERNA,IM 1080428,,74.0,M,"DEATH Narrative: 73 y.o. male with pmh severe COPD, CAD, HTN, hypothyroidism, OSA treated with CPAP, obesity. Noted to have engaged with Pulmonary clinic in December 2020 for worsening respiratory status. No PFTs since 2015. Was found slumped over deceased in his home on the afternoon of 2/24/2021. Medical Examiner notified. Request sent to ME office for report if one exists. No drugs or alcohol were found on the scene andno sign of trama. Hypertensive cardiovascular disease were reported as an adequate cause for death. ""pathologist"" reported that Covid vaccine does not need to be listed as it was ""more than 24 hours since the shot"".",Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/24/2021,1.0,OTH,,,,,,"['Death', 'Hypertensive heart disease']",1,PFIZER\BIONTECH,IM 1080429,,84.0,M,"DEATH Narrative: no documentation regarding any immediate reaction after vaccine administration. 83 y.o. male with pmh severe pulmonary hypertension, s/p TAVR last year, severe asbestos related lung disease on chronic oxygen, recently started on palliative care. Was found by daugher deceased on the morning of 2/11/2021. Autopsy declined by family.",Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/11/2021,1.0,OTH,,,,,,['Death'],1,MODERNA,IM 1080430,,59.0,M,Death Narrative: Death was not determined to be related to COVID vaccination. COVID vaccination (dose 1) occurred on 1/27/21 with no noted side effects. Death occurred on 2/14/21.,Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/14/2021,18.0,OTH,,,,,,['Death'],UNK,MODERNA,IM 1077312,NM,36.0,F,"Leg and hip pain, nerve pain on left side. Shingles mainly on left side but also on right indicating something severely wrong in a young healthy patient.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/17/2021,02/22/2021,36.0,PHM,Thyroid,None,None,,"Grass, Latex","['Arthralgia', 'Blood test', 'Gait inability', 'Herpes zoster', 'Magnetic resonance imaging', 'Neuralgia', 'Pain in extremity', 'X-ray']",1,MODERNA,IM 1077317,CA,86.0,M,EXTREME TIREDNESS; FEVER OVER 100; EXTREME WEAKNESS; NEED TO SLEEP - 23.5 HOURS,Not Reported,,Not Reported,Yes,3.0,Not Reported,U,03/03/2021,03/03/2021,0.0,PVT,TYLENOL; OMEPRAZOLE DR 40 MG 1XDAILY; SERTRALINE HCL 100MG 1XDAILY,NONE,"LOWER SPINE ARTHRITIS, ESOPHAGEAL ULCERS, NON-DIABETIC FOOT ULCER",,MORPHINE: CAUSES DEPRESSION IN OXYGEN INTAKE,"['Asthenia', 'Blood test', 'Fatigue', 'Hypersomnia', 'Pyrexia']",1,PFIZER\BIONTECH,SYR 1077321,CO,69.0,M,Temp of 99.6 Muscle aches Chills Rigors Uncontrolled shaking,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,OTH,Ibuprofen 200 mg. Got temp of 99.6 Potassium Cl Sr 20MEQ Hydrochlorothiaz 25 mg Diltiazam CD 180 mg,Hypertension Obsessive compulsive disorder Coronary artery disease,Gerd,,"Patient is having fever of 99.6 with muscle pain, chills and uncontrollable rigors.","['Chills', 'Myalgia', 'Pyrexia']",UNK,JANSSEN,IM 1077339,FL,81.0,M,"Patient received second dose of Pfizer vaccine 2/21/21. Patient is unable to recall the name of facility that he received the vaccine, but states that it was at a clinic. Patient's vaccination card was left at home. Patient developed symptoms of shortness of breath on 2/24/21, which were mild at first but progressed to severe and resulted in him coming to the hospital on 2/26/21. Patient had a thorough cardiac work-up and it was found that patient has severe aortic regurgitation. Patient is still hospitalized waiting for a TAVR on Monday, 3/8/21.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/21/2021,02/24/2021,3.0,PUB,"Apixaban, Cholecalciferol, Coenzyme Q10, Dofetilide, Doxazosin, Lactobacillus Combination No. 13, Magnesium Oxide, metoprolol, multivitamin, pantoprazole, simvastatin, topiramate, vitamin B complex",,"Atrial fibrillation, Aortic valve replacement (1988 and 2008), Coronary artery bypass graft (2008), Chronic kidney disease, BPH, Gout",,"Keppra, phenytoin, Xarelto, latex","['Aortic valve incompetence', 'Cardiovascular evaluation', 'Dyspnoea']",2,PFIZER\BIONTECH,IM 1077341,MD,65.0,F,"Feet & calves extremely warm, no fever. Upset stomach, malaise, slight difficulty breathinh",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,SCH,"Anti-depressant, anti-anciety, insulin, met forming, thyroid rx, cholesterol Rx",None,"Diabetes. Anxiety, depression, stones in gall bladder, thyroid",No but my son died from. Peryes as a child don't recall which h one.. .y son died from pertussis vCcine,"Ritalin, statins","['Abdominal discomfort', 'Dyspnoea', 'Malaise']",1,JANSSEN,SYR 1077351,NJ,47.0,M,Heart Attacks,Not Reported,,Yes,Yes,4.0,Not Reported,N,02/12/2021,02/18/2021,6.0,PVT,"Lotrel, Toprol",,Hypertension,,None,['Myocardial infarction'],1,MODERNA,IM 1077356,ID,93.0,M,Presented to the ED with profound weakness including inability to ambulate (at baseline goes on moderate distance walks daily without assistive devices). Patient admitted to hospital on observation due to inability for him or his family to take care of himself due to the profound weakness.,Not Reported,,Not Reported,Yes,1.0,Not Reported,U,03/04/2021,03/05/2021,1.0,PVT,None.,None.,"Atrial fibrillation, hypertension, coronary artery disease.",,Sulfa.,"['Asthenia', 'Blood bilirubin increased', 'Blood creatine phosphokinase normal', 'Chest X-ray normal', 'Full blood count normal', 'Gait inability', 'Impaired self-care', 'Laboratory test', 'Metabolic function test', 'Platelet count decreased', 'Urine analysis normal']",2,MODERNA,IM 1077359,OH,26.0,F,"Aches in both arms (mostly in arm that was vaccinated), backache, restlessness, insomnia, headache, overall body fatigue. All of these things caused me to wake up in the middle of the night around 3:30 AM the day after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/05/2021,03/06/2021,1.0,PHM,"Tr-sprintec, meclizine",,,,,"['Back pain', 'Fatigue', 'Headache', 'Insomnia', 'Limb discomfort', 'Restlessness']",UNK,JANSSEN,IM 1077369,TX,45.0,F,Body feels heavy like lead Very tired Minimal pain at injection site 2:18pm hands twitching and my right eye feels like it's swollen and burning closer to my cheek and then started twitching uncontrollably. Very dry mouth. Moments later body tremors and vomiting. Ended up being taken to the emergency room will elaborate later. Drink Sprite on the way home vomited it up as soon as I walked in the door. Not the feeling of nausea just the vomiting is coming. Took temperature have a fever of 101.0 DAY 2 Tremors while walking Headache Body aches Minimal taste Tingling around eye No real desire to eat Managed to keep some noodles down Today is Day 3 5:00am Still unsteady on feet when walking Still have headache and body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/04/2021,0.0,OTH,Took tylenol at 6am morning of Vaccination. Vitafusion triple immune power elderberry 2 gummies Vitafusion D3 50mcg 2000 IU 2 gummies,Breast abcess (L),Overweight,,Sensitivity to penicillin Allergic to morphine,"['Chest X-ray', 'Dry mouth', 'Eye swelling', 'Fatigue', 'Headache', 'Hypogeusia', 'Injection site pain', 'Muscle twitching', 'Pain', 'Paraesthesia', 'Pyrexia', 'Tremor', 'Vomiting']",1,JANSSEN,SYR 1077371,IL,38.0,F,"Patient had sudden onset of sensation of palpations and light headedness ""lasting one second"" in middle of night on the day after receipt of COVID-19 vaccine. Felt urgent need for medical treatment & came to our ER. Has had similar episodes previously that have been partly diagnosed as anxiety though without light-headedness. Vitals in ER HR 141, BP 147/101. Believed to be sinus tachycardia. Has been prescribed venlafaxine, lorazepam, and metoprolol previously for this. Has seen cardiologist but per patient no specific diagnosis. As yet, patient has received a fluid bolus in ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,UNK,,,,,,"['Blood pressure increased', 'Dizziness', 'Palpitations']",UNK,JANSSEN,IM 1077385,OH,61.0,F,day 1 severe hot and cold flashes bad headache and severe arm pain today could not stand up sat down felt Like I was going to pass out sat on floor bad cold sweats feeling nauseous bad diarrhea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/04/2021,0.0,PVT,"VitaFusion, Women's Complete Multivitamin, VitaFusion, vitamin C",none,none,,"penicillin , arithmetician, iodine","['Cold sweat', 'Diarrhoea', 'Dizziness postural', 'Feeling cold', 'Headache', 'Hot flush', 'Nausea', 'Pain in extremity']",UNK,JANSSEN,IM 1077387,NC,50.0,M,"Starting approx 7 hours after injection I started to feel run down. I then played tennis for about 45 minutes. I got home around 8:30 and started to experience extreme chills, fever of 100.4, joint aches in feet, hands, neck, wrists, shoulders, hips. Headache. I did not take any additional medication - toughed it out. This morning is approx 22 hours after vaccine. I could not sleep more than an hour or so, I was very chilled and achy. I am currently feeling a little better but still have aches in my back and wrists and ankles, have a headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,PHM,"81 mg aspirin, prasugrel 10mg, trintellix 20mg, lisinopril 2.5mg, metoprolol 25mg twice daily, atorvastatin 40mg",None,"Heart disease, obesity",,None,"['Arthralgia', 'Chills', 'Headache', 'Insomnia', 'Pyrexia']",1,JANSSEN,SYR 1077420,MI,73.0,M,"Started shaking inside my body 8 hours after the shot plus a fever of 100. Shaking then turned violent on outside of my body. Took 2 Motrin (225) each. Shaking stopped after 30 minutes, fever disappeared overnight.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,UNK,Losartan 50MG Lovastatin 20MG,None,Heart Attack,,None,"['Nervousness', 'Pyrexia', 'Tremor']",1,JANSSEN,SYR 1077422,OK,19.0,F,"Headache/ achy bones, painful movement in most joints",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,PUB,None,,Asthma,,None,"['Arthralgia', 'Bone pain', 'Headache']",UNK,JANSSEN,SYR 1077425,MS,58.0,F,Started with fever of 99.4 which rose to 101.4 at about 2:30 am. I ended up taking tylenol at about 2:30 am and my fever broke by time I woke up at 6:30 am,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,None,None,None,,None,['Pyrexia'],1,JANSSEN,IM 1077452,MN,92.0,F,"Death felt a little sick 1 day after shot 2/28/21, felt worse next day 3/1/21 was weak, she was found dead am 3/2/21 on the floor in her bedroom 1/2 way between bathroom and bed.",Yes,03/02/2021,Not Reported,Not Reported,,Not Reported,N,02/27/2021,02/28/2021,1.0,PUB,lisinopril,"no illness, had first Pfizer covid vaccine 2/2/21",hypertension,,penicillin,"['Asthenia', 'Death', 'Malaise']",2,PFIZER\BIONTECH,IM 1077453,CO,37.0,M,"Headaches, chills, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,PUB,"Multi vitamin, vitamin C and D3",None,None,,None,"['Chills', 'Fatigue', 'Headache']",UNK,JANSSEN,SYR 1077499,OH,60.0,M,Fever started 10 hours post injection. Fever was 99.1. Also body aches. Next day was fatigued and had small rash at the base of my neck in front.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/05/2021,1.0,OTH,B12,None,None,,None,"['Fatigue', 'Pain', 'Pyrexia', 'Rash']",UNK,JANSSEN,SYR 1077529,LA,59.0,F,"severe headache, chills for about 6 hours; flushed cheeks; body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,Hydrochlorothiazide12.5mg; bupropion hcl er 150mg; claritin; enalapril maleate 10mg; atorvastatin calcium 20mg; baby aspirin,none,high blood pressure,,none,"['Chills', 'Flushing', 'Headache', 'Pain']",UNK,JANSSEN,IM 1077533,OH,72.0,F,"first attempt to adminster vaccine at the top of shoulder, health care provider bent needle. the needle was replaced and the vaccine was injected at top of shoulder and collarbone. after injection, I went home awaken about 2:30am with pain in the intire left arm. I still have pain after one month. for about 10 days I could not use arm. I am now 85% pain free. I still can not lift arm above head I did not want my friends and family to know how servere my pain was for fear they would not want to get the vaccine. I have never had vaccine of any type in the area that this vaccine was injected. I did not go to doctor's office due to weather 14 inches of snow. however, I did make my primary physican aware of issue...",Not Reported,,Not Reported,Not Reported,,Yes,N,01/05/2021,01/06/2021,1.0,OTH,"blood preasure, colstrol",none,back issure,,none,"['Incorrect route of product administration', 'Injected limb mobility decreased', 'Needle issue', 'Pain in extremity', 'Sleep disorder']",1,MODERNA,IM 1077534,DC,62.0,M,"Received vaccine in morning on 2/2/2021. No noted reaction. Next morning 2/3/2021, patient started vomiting blood/coffee ground emesis. Sent to ER. Hospitalized. Recovered and readmitted.",Not Reported,,Yes,Yes,6.0,Not Reported,Y,02/02/2021,02/03/2021,1.0,SEN,"Calcium acetate, metoprolol, clopidogrel, aspirin, isentress. ferris sulfate, pantoprazole. amlodipine, Intelence, miralax, potassium, ritonavir, tylenol,",,"hypertension, HIV, GERD, ESRD, chronic Hep C, mood disorder",,nada,['Haematemesis'],1,MODERNA,IM 1077536,MO,32.0,F,"6 hours in: feeling cold, muscle aches 7 hours in: extreme chills and nausea 8 hours in: extreme chills, muscle aches, feverish 13-14 hours: chills subside, muscle aches, hot/feverish 20 hours: muscle aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,SEN,"Vitamin D3, vitamin B12, St. John's Wort, multivitamin, CBD oil, Loratadine",,,,,"['Chills', 'Fatigue', 'Feeling cold', 'Myalgia', 'Nausea', 'Pyrexia']",UNK,JANSSEN,SYR 1077558,IA,28.0,M,"Muscle aches in armpits began a few hours after receiving the dose. Within 8 hours of dose, a mild fever and chills began (around 100 degrees F). I attempted to take a bath to soothe aches but it did not help, and instead tried to go to sleep at 8:30 pm. A slight red rash appeared on chest and arms around this time. I was woken up at 10:30 pm feeling disoriented and hot, with a fever of 104.5 degrees F. My wife noticed slurring of words and that I seemed unstable and confused, and symptoms were severe enough we considered going to the emergency room. I experienced ringing in my ears and a severe headache. I took 2 extra strength Tylenol, put a cold cloth on forehead, and drank fluids to fall back asleep. Fever dropped to around 102 but continued throughout the night. I woke up at 6:30 am and took two more Tylenol. The severe headache continued and I vomited twice. I attempted to take a shower and rinse off, and continue to rest. Fever is reduced to 99 degrees F with help of Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,WRK,None,None,None,,None,"['Balance disorder', 'Chills', 'Confusional state', 'Disorientation', 'Dysarthria', 'Feeling hot', 'Headache', 'Myalgia', 'Pyrexia', 'Rash', 'Tinnitus', 'Vomiting']",1,JANSSEN,IM 1077592,LA,37.0,F,"Severe headache, chills, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,OTH,None,None,None,,None,"['Chills', 'Headache', 'Pain']",1,JANSSEN,SYR 1077619,IL,36.0,M,Went to bed around 10 pm. Woke up at 11:30 with moderate to severe chills and 100 degree fever. Added blankets and clothes. Took Tylenol. Drank water. Chills subsided. At 12:45am temp was 100.4 degrees F. Woke up at 6am. Temp was 98.2. Took Advil at 6am to help with muscle aches from the chills.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PVT,"Flonase, Claritin, omega 3, probiotic",,Seasonal allergies and Eczema,,Amoxicillin,"['Chills', 'Myalgia', 'Pyrexia']",1,JANSSEN,IM 1077621,CO,,F,"Dizzininess, nausea, vomiting,",Not Reported,,Not Reported,Yes,,Not Reported,N,02/21/2021,02/26/2021,5.0,PVT,"Juice plus, amino, magnesium , vitamin d, glucosimine",none,none,,none,"['Blood test', 'Computerised tomogram head', 'Dizziness', 'Electrocardiogram', 'Full blood count', 'Magnetic resonance imaging head', 'Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH, 1077643,KS,19.0,M,Originally seen for chest pain later learned it was a Heart attack and myopericarditis,Not Reported,,Yes,Yes,2.0,Not Reported,N,02/19/2021,02/21/2021,2.0,PUB,"Sertriline, buspirone",,Asthma,,Shellfish,"['Blood test', 'Catheterisation cardiac', 'Chest pain', 'Echocardiogram', 'Electrocardiogram', 'Myocardial infarction', 'Myocarditis']",UNK,MODERNA,SYR 1077656,,29.0,F,"49 hours after I began to feel dizzy, my ears clogged and I felt generally bad. I was sent to a doctor who sent me to a hearing test. My right ear got damaged and cannot hear below ~40-50 decibel on all frequencies. + I got tinnitus. The treatment I got is Prednisolone 60 mg daily for a week. 4 days, nothing changed so far",Not Reported,,Not Reported,Not Reported,,Yes,N,03/01/2021,03/03/2021,2.0,UNK,Tenofovir Teva,-,HBV carrier,,None,"['Acoustic stimulation tests abnormal', 'Deafness unilateral', 'Dizziness', 'Ear discomfort', 'Feeling abnormal', 'Tinnitus']",1,PFIZER\BIONTECH,SYR 1077657,MO,66.0,F,"Left arm was mildly sore, as expected. Around 10 pm Thursday, I started feeling chills. During the night I felt fevers and chills alternating. Around 3 am, I was nauseous and vomited, although there wasn't much actual vomit. I vomited again around 9 am the next morning, with even less vomit, since I hadn't eaten any breakfast. I rested most of Friday and ate sparingly. Today (Saturday) I feel better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,OTH,"Alendronate Sodium, last dose before vaccination was 2/27/2021. Calcium tablet Vitamin D3 2000 mg Womens 50+ multi-vitamin",None known,osteopenia (being treated with alendronate sodium),Sore arm at injection site with flu shots,amoxicillin some perfumes,"['Chills', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,JANSSEN,IM 1077658,MD,37.0,M,"Flu-like symptoms. Body aches, fever, chills, headache, nausea. Started around 8 hours after vaccination and lasted over 10 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PUB,"Esomeprazole, bupropion",,"Depression, GERD",,Ibuprofen,"['Chills', 'Headache', 'Influenza like illness', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1077667,MA,77.0,M,"Weakness resulting in fall, rhabdomyolysis, elevated troponin and hospital admission",Not Reported,,Not Reported,Yes,,Not Reported,U,02/04/2021,03/04/2021,28.0,PVT,"aspirin, calcium, atorvastatin, benefiber, docusate apixiban, carvedilol, lasix, lisinopril, tamsulosin",,"Afib, CHF, BPH, UTI",,"fish, shellfish, tramadol, duragesis, dioxide","['Asthenia', 'Blood creatine phosphokinase increased', 'Fall', 'Rhabdomyolysis', 'Troponin']",UNK,MODERNA,IM 1077723,MA,79.0,F,Patient had long cardiac pauses and had to get a pacemaker. Symptoms started two days after the vaccination,Not Reported,,Yes,Not Reported,,Not Reported,U,03/03/2021,03/06/2021,3.0,UNK,"Furosemide 20 mg BID, meclizine 12.5 mg PRN, sivastatin 20 mg QD, warfarin 2 mg QD, glipizide 10 mg BID, levothyroxine 175 mcg daily, clonidine 0.1mg QD, metformin 850 mg BID",None,"diabetes, CHF, Hypertension, Hyperlipidemia, vertigo, blood clot, prior stroke",,no known allergies,"['Arrhythmia', 'Cardiac pacemaker insertion']",UNK,MODERNA, 1077755,CA,70.0,M,"Chills, muscle fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/05/2021,03/06/2021,1.0,PHM,Omeprezole,,,,,"['Chills', 'Muscle fatigue']",UNK,JANSSEN,IM 1077756,CT,31.0,F,"Headache, body ache, fever, tiredness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,OTH,Lamotragine (200mg per day) Abilify (2mg per day),,,,Penecillin,"['Fatigue', 'Headache', 'Pain', 'Pyrexia']",UNK,JANSSEN, 1077758,WI,81.0,M,"Per neurology consult: ""Patient was at his baseline until when he received his 2nd dose of SARS-CoV-2 vaccination. He complained of dyspnea and fear of impending doom after waking up the following morning with some disorientation. He was found to be in AFib with RVR after it was brought to ER the following morning and the rhythm was converted to normal sinus rhythm. Patient continues to have confusion after admission yesterday that seem to get worse today to the point where he did not know his own name or birthdate, and seemed to have global amnesia. Patient has been more drowsy this afternoon after receiving lorazepam 1 mg IV for potential seizure activity so no reliable neurologic exam was obtained. Patient remains afebrile with pulse ox in the low 90s on 4 L of supplemental nasal oxygen in the hospital. He had moderate decrease in kidney function upon admission that has improved. He has baseline anemia with hemoglobin at around 10. Incidentally patient had shingles in the right thoracic dermatome week ago for which he received valacyclovir.",Not Reported,,Not Reported,Yes,,Yes,U,03/01/2021,03/02/2021,1.0,PVT,,,,,,"['Amnesia', 'Anaemia', 'Atrial fibrillation', 'Confusional state', 'Disorientation', 'Dyspnoea', 'Fear', 'Renal impairment', 'Somnolence']",2,MODERNA,IM 1077782,OR,34.0,F,"Intense body aches, pain and chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,PVT,no,no,no,,no,"['Chills', 'Pain']",UNK,JANSSEN,SYR 1077790,MD,42.0,F,"Guillain-Barre-Landry Syndrome (AIDP). Presented with paresthesia's, loss of Deep Tendon Reflexes, and proximal > distal LE weakness. Placed on IVIG on 3/4/2021 with improved symptoms of LE weakness but noted residual abnormal sensation",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,02/11/2021,02/17/2021,6.0,PVT,None,None,"None, prior hypertension",,None,"['Areflexia', 'Electromyogram', 'Guillain-Barre syndrome', 'Immunoglobulin therapy', 'Laboratory test', 'Lumbar puncture', 'Muscular weakness', 'Nerve conduction studies', 'Paraesthesia', 'Sensory disturbance']",2,PFIZER\BIONTECH,IM 1077796,UT,67.0,F,"Chills, fever, headache; took 400 mg ibuprofen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,PHM,D3 - 50 mg Zinc Chelate 30 mg,none,none,,none,"['Chills', 'Headache', 'Pyrexia']",,JANSSEN,IM 1077804,AR,75.0,M,Persistent hypoglycemia (30s) causing confusion,Not Reported,,Not Reported,Yes,,Not Reported,,03/05/2021,03/05/2021,0.0,PVT,"allopurinol, asa, diprolene, clonazepam, duloxetine, hctz, famotidine, synthroid, linzess, omeprazole, zaleplon",none,parkinsons,,"iodone, latex, tape","['Confusional state', 'Hypoglycaemia']",2,MODERNA,IM 1077812,NY,36.0,F,"Mild fever (99.8, normal resting body temp 97.1)",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/06/2021,0.0,OTH,Pew natal bitamin,None,No e,,Latex,['Pyrexia'],1,JANSSEN,IM 1077845,UT,59.0,M,"Eyes burning, fatigue, soreness at injection site, muscle aches (not manifest until following day).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,PVT,"Met forming, glimiperide, atorvistatin, omeperazole, and Jardine. Also 2000 mg vitamin C and a magnesium- calcium-zinc tablet",None,"Diabetes Type 2, gastroparesis",,Penicillin and demarol,"['Eye irritation', 'Fatigue', 'Injection site pain', 'Myalgia']",1,JANSSEN,SYR 1077855,WA,56.0,F,"Patient experienced dizziness, elevated blood pressure and increased heart rate. Diphenhydramine 50mg IM was administered into right deltoid.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,SCH,,,,,Allergy shots,"['Blood pressure increased', 'Dizziness', 'Heart rate increased']",1,JANSSEN,IM 1077868,FL,31.0,F,"Head ache, extreme chills, fatigue, slight nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,OTH,Testosterone cypionate,,,,Sulfa drugs,"['Chills', 'Fatigue', 'Headache', 'Nausea']",1,JANSSEN,SYR 1077874,MS,37.0,F,"JANSSEN COVID-19 VACCINE EUA Chills, body aches, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,N/a,N/a,N/a,,N/a,"['Chills', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1077879,MD,69.0,F,"Dizziness, headache, nauseousness to the point of having to sit still. Home treatment with Ibuprofen reduced symptoms that lasted approximately 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,OTH,"Daily vitamin for adults over 55, Multiple Vitamin B, Calcium Citrate 500 mg (2X/day), Trazadone 25mg evening, Topical Ivermectin",None,"Meniere's disease in active state with hearing loss and fullness in one ear, Rosacea, Insomnia,",,"Anitbiotics -penicillin, amoxicillin, and other broad spectrum antibiotics","['Dizziness', 'Headache', 'Nausea']",1,JANSSEN,IM 1077901,NY,64.0,M,PATIENT GOT THE VACCINE AND WAS TOLD TO SIT DOWN FOR 15 MINUTES . DURING THAT TIME PT FAINTED .CALLED 911 AND WAS TAKEN TO THE HOSPITAL,Not Reported,,Not Reported,Yes,,Not Reported,U,03/06/2021,03/06/2021,0.0,PHM,NONE,NONE,NONE,,NONE,['Syncope'],1,MODERNA,IM 1077902,MN,21.0,F,"Janssen COVID-19 Vaccine EUA Body aches and pains (specifically on left side of body and in lower back), lasted for ~14 hours. Migraine-like headache, currently ongoing but started 11 hours ago. Unable to sleep due to these moderate-severe amounts of pain (woke up at 3am unable to go back to sleep).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,OTH,"Vyvanse, birth control",none,asthma,,penicillin,"['Migraine', 'Pain']",UNK,JANSSEN, 1077949,IN,55.0,F,I have had a fever daily since receiving the 2nd vaccine ranging from 99.4-100.8. In the past week it has been above 100 in the evenings,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,WRK,Levothyroxine; Lisinopril HCTZ; Zolpidem; Vitamin D and C,Methemoglobinemia; chronic lymes disease issues,Methemoglobinemia; chronic Lymes issues,,Sulphate; Vancomycin; Vantin; Levaquin; shellfish; coconut,"['Culture negative', 'Full blood count normal', 'Pyrexia']",2,MODERNA,IM 1077957,IN,73.0,M,High fever,Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,02/17/2021,02/19/2021,2.0,UNK,"Low dose aspirin, Centrum Silver multivitamin, fish oil capsule, garlic oil capsule, tamsulosin (FLOMAX) 0.4MG",None,None,,Penicillin,['Pyrexia'],2,MODERNA,SYR 1077967,OH,61.0,F,Mega headache (I get headaches so I know it was bad) about 3 hours afterwards. Really cold and falling asleep about 5 hours after. Next day generally just cold and body tired. No arm pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PHM,None,None,None,,One,"['Fatigue', 'Feeling cold', 'Headache', 'Somnolence']",UNK,JANSSEN, 1077976,MO,29.0,M,"lymph nodes started swelling in a few hours. Woke up in middle of night with 100.3 degree fever, aches, chills, congestion, and congestion related headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,PHM,None,None,None,,None,"['Chills', 'Headache', 'Lymphadenopathy', 'Nasal congestion', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1077988,CO,38.0,F,"# AKI with non-nephrotic range proteinuia and microscopic hematuria # Neutrophilia # Fevers # Normocytic anemia # Thrombocytosis # Coagulopathy # RUE Superficial venous thrombosis # Subconjunctival hemorrhage # Flame hemorrhage R fundus # Mild iridocyclitis # CRP elevation # Procalcitonin elevation # D Dimer elevation # Anasarca # Elevated BNP # Hypoalbuminemia # Small pericardial effusion # Elevated alk phos, bilirubin (direct predominant), and AST # Elevated lipase # Hypocomplementemia with low CH50 # Elevated IL2 Receptor (8540) # Aseptic meningitis w CSF with lymphohistiocytic predominant pleocytosis (25 nuc cells with 49% lymphs, 35% histiocytes, 16% pmn, glucose 41, protein 155 with neg meningoencephalitis panel)",Not Reported,,Not Reported,Yes,18.0,Not Reported,N,01/28/2021,02/11/2021,14.0,UNK,None,,,,Dilaudid- vomiting,"['Acute kidney injury', 'Aspartate aminotransferase increased', 'Bilirubin conjugated increased', 'Blood alkaline phosphatase increased', 'Brain natriuretic peptide increased', 'C-reactive protein increased', 'CSF test abnormal', 'Coagulopathy', 'Conjunctival haemorrhage', 'Fibrin D dimer increased', 'Generalised oedema', 'Haematuria', 'Hypoalbuminaemia', 'Hypocomplementaemia', 'Interleukin-2 receptor assay', 'Iridocyclitis', 'Lipase increased', 'Meningitis aseptic', 'Neutrophilia', 'Normocytic anaemia', 'Pericardial effusion', 'Pleocytosis', 'Procalcitonin increased', 'Proteinuria', 'Pyrexia', 'Retinal haemorrhage', 'Thrombocytosis', 'Total complement activity decreased', 'Venous thrombosis limb']",UNK,PFIZER\BIONTECH, 1077998,CO,66.0,F,Hives all day & night controlled by using benedryl,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PUB,"Vitamin D3-4000IU, 1- Zinc-50mg, C- 1500mg, Womens Energy metabolism & bone support , gummy vitamins 2. B-12 injections of 2cc - cyanocobalamin per week, levothyroxine 175MCG- 2 tablet AM, Estradiol 0.5MG cream 2 pumps (1ML) .",none,"pernicious anemia, thyroid disorder",Shingles,"penicillin, shell fish, scallops, adhesive, latex , kale, beets",['Urticaria'],1,JANSSEN,IM 1078001,MD,23.0,F,"Janssen COVID-19 Vaccine EAU Headache, dizziness, and nausea starting around 2 and a half hours after vaccination. Left work early due to not feeling well enough to continue.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/06/2021,0.0,UNK,Oxybutynin cl er 5 mg Levono-e estrad 0.15-0.03-0.01,,,,Sulfa antibiotics,"['Dizziness', 'Headache', 'Nausea']",1,JANSSEN,IM 1078002,NY,69.0,M,"Fever, tiredness, headache, body ache and chills and cough. Patient passed away at homeThursday, March 5 around 5:00 a.m.",Not Reported,,Not Reported,Not Reported,,Not Reported,,02/22/2021,02/22/2021,0.0,PHM,,,,,,"['Chills', 'Cough', 'Death', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,MODERNA,IM 1078033,CO,23.0,M,"Janssen COVID-19 Vaccine EUA. Chills, headache, body aches, mentally fogginess, slight nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,PVT,"25 mg, Losartan. One-A-Day multivitamin. Claritin.",None.,High blood pressure,,None.,"['Chills', 'Feeling abnormal', 'Headache', 'Nausea', 'Pain']",1,JANSSEN,SYR 1078035,NV,51.0,M,5-6 hours after the shot I got chills and could not get warm. I went to bed and had mild aches and had to wear a jacket to keep warm. Woke up 4am because could not sleep and was ok with only mild aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PHM,None,No,None,,None,"['Chills', 'Pain', 'Sleep disorder']",1,JANSSEN,SYR 1078063,PR,36.0,M,Patient's muscle aches and health problems with stomach ulcer with internal bleeding and tarry stool in the excreta,Not Reported,,Yes,Not Reported,,Not Reported,N,03/04/2021,03/06/2021,2.0,PVT,No medication,Ulcers in the stomach at the time of filling this I have a bleeding ulcer presenting tarry stool in the excreta,Ulcers in the stomach,Bleeding ulcer with tarry stool body ache and shivers 3/4/2021,None,['Myalgia'],2,PFIZER\BIONTECH,SYR 1078067,IA,26.0,M,"Friday night at about 10ish I suddenly got a terrible migraine, shaking uncontrollably, and my body have stiff. I tried going to bed at 11pm, but couldn't fall asleep. I got up sometime around 2am and I still had all of these along with extreme nausea. Check my temperature, it was 101.4 F. Got more blankets and tried to get some sleep, but took a while due to the migraine. At 7:30am, the shaking was gone and the migraine was not as bad, but I still had a temperature of 99.1 F and nausea. After calling my boss and mother, I went back to sleep. Stayed in bed until about 1:45pm Saturday. By then, the migraine was manageable and nausea was not as bad, though still had a temperature of 99.9 F. Took a shower and took 2 pills of ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PUB,None,None,None,,None,"['Migraine', 'Musculoskeletal stiffness', 'Nausea', 'Pyrexia', 'Tremor']",1,JANSSEN,SYR 1078081,AZ,78.0,F,"Guillian Barre reaction (difficulty walking, difficultyusing hands- small motor skills; difficulty speaking; began on 2/7/21 and continued to worsen until hospitalization on 2/24/21 and 5 plasmapheresis treatments. While hospitalized patient has developed double vision.",Not Reported,,Not Reported,Yes,6.0,Yes,N,02/05/2021,03/06/2021,29.0,PVT,"benazapril dystolic hydralazine pantoprazole atorvastin calcium furosemide spririva multiple vitamin calcium, D & magnesium vitamin c vitamin e Glucosamine hci Condroitin Sulfate omega 3 fish oil CoQ-10 Aspirin Metamucil","high blood pressure that is treated, that is monitored",same as above,,sulfa gives a gastric reaction,"['Diplopia', 'Fine motor skill dysfunction', 'Gait disturbance', 'Guillain-Barre syndrome', 'Lumbar puncture', 'Speech disorder']",1,PFIZER\BIONTECH,IM 1078095,WA,56.0,F,"Extreme dizziness, red face, high blood pressure, tingling tongue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,WRK,none,none,none,,none..only environmental,"['Dizziness', 'Erythema', 'Hypertension', 'Paraesthesia oral']",1,JANSSEN,SYR 1078109,NJ,51.0,F,"COUGH, TINGLING THROAT AND TONGUE WITH SLIGHT SWELLING OF THROAT AND TONGUE",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,"CITALOPRAM 10MG, CITALOPRAM 20MG, PREMPRO 0.625-2.5 MG, ASMANEX HFA 200MCG, PANTOPRAZOLE 40MG, MONTELUKAST 10MG,",NONE,"GERD, DEPRESSION, SEASONAL ALLERGIES, AND ASTHMA",,NONE,"['Cough', 'Paraesthesia oral', 'Pharyngeal paraesthesia', 'Pharyngeal swelling', 'Swollen tongue']",1,JANSSEN,IM 1078114,MD,71.0,F,"Woke up at 4AM on 03/05/2021 with shaking chills, feeling very cold, couldn't get warm. Shaking so bad I couldn't get whole sentences out. Body aches and stiffness, affected my walking. Did not take temperature at that time. Got back into bed with 2 blankets and a comforter and still couldn't sleep. Got up a 7AM - temp 102.2, shaking less but still feeling cold, body was hot to touch. I had a bad headache and body aches and stiffness were still there. I noticed at that time that I had a bright red flush on both cheeks and my nose that was hot to the touch. Took 600mg of Ibuprofen. Went back to bed feeling terrible. At 12 noon I got back up and temp was down to 99.7. Headache, body aches, stiffness, and ""red flush"" still on cheeks and nose. Went back to bed. Took more Ibuprofen at 7pm - temp was down to 98.7. Headache was better, body aches improved. Flushed hot face was still present. Went to sleep at 11:30PM and slept for 10 hours. Today, 03/06/21, all symptoms improved, no fever, redness of face is still present but less.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/04/2021,03/05/2021,1.0,OTH,Metoprolol 25mg 2xdaily Singulair 10mg daily Zyrtec 10mg daily HCTZ 12.5mg daily Symbicort Inhaler 2puffs 2xdaily Albuterol Inhaler 2 puffs prn asthma symptoms Flonase Nasal Spray one spray both nostrils daily Centrum Multivitamins daily,Asthma flare ups Sinus Infection,Asthma Polymyalgia Rheumatica Hypertension Irregular Heart Beat (PVCS) Sinus Problems,,None,"['Chills', 'Feeling abnormal', 'Feeling cold', 'Flushing', 'Gait disturbance', 'Headache', 'Musculoskeletal stiffness', 'Pain', 'Pyrexia', 'Skin warm', 'Tremor']",,JANSSEN,IM 1078117,,69.0,F,"Patient c/o throat closing, SOB, and chest pain within minutes after receiving the vaccine. Her vital signs showed tachycardia, increased respirations, and elevated blood pressure. She had a hard time speaking in full sentences. She does have a history of anaphylaxis to certain medications. She was administered epinephrine auto injector IM and brought to the emergency department by rapid response team.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/06/2021,0.0,PVT,,,,,,"['Blood pressure increased', 'Chest pain', 'Dyspnoea', 'Respiratory rate increased', 'Tachycardia', 'Throat tightness']",1,JANSSEN,IM 1078121,VA,44.0,F,Immediately tasted a metallic taste and numbness in my cheeks. When I got home I had a rapid heart rate and slight shortness of breath. That night I ran a fever of 102 and had horrible chills and nausea. The next day these were gone but I had a horrible headache that even Tylenol wouldn?t get rid of. The second day these symptoms had stopped.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,PHM,Prenatal vitamins,,Asthma,,"Ct scan dye, cechlor","['Chills', 'Dysgeusia', 'Dyspnoea', 'Headache', 'Heart rate increased', 'Hypoaesthesia', 'Nausea', 'Pyrexia']",UNK,JANSSEN,SYR 1078122,CO,32.0,F,"Vasovagal response, dizziness, blood pressure drop, irregular heart beat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PUB,,None,,,,"['Blood pressure decreased', 'Dizziness', 'Heart rate irregular', 'Presyncope']",1,JANSSEN,IM 1078128,NJ,37.0,M,"The patient had fever lasting 2 days and left arm pain lasting 4-5 days after the first dose. After the second dose, he also had a fever the first day, developed severe pain in the right arm with swelling and sensation of heat which did not respond to ibuprofen; radiation of pain down to his hand and into his upper chest, all of which persisted for several days, requiring a visit to the emergency department on 2/12/21, where a workup including CBC, chem, CK as well as an x-ray of his shoulder and venous doppler study were negative. His pain and swelling have persisted for over a month although they are starting to gradually improve.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/02/2021,02/03/2021,1.0,PVT,none,none,"hyperlipidemia, obesity",,none,"['Blood creatine phosphokinase normal', 'Chest pain', 'Feeling hot', 'Full blood count normal', 'Laboratory test normal', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Ultrasound Doppler normal', 'X-ray limb normal']",2,MODERNA,SYR 1078153,MA,58.0,F,"Janssen COVID-19 Vaccine EUA Chills, fever, upset stomach, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/06/2021,1.0,PVT,Levothyroxine,none,none,,Adverse reaction to shellfish,"['Abdominal discomfort', 'Chills', 'Fatigue', 'Pyrexia']",1,JANSSEN,IM 1078162,OR,31.0,F,"Fever so far reaching 100.2, headache, neck pain, weakness, skin sensitivity, hair sensitivity, nausea, muscle and joint pain, muscle spasms/cramps with short term weakness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,PHM,"Levothyroxin, vitamin d, vitamin b complex, top-rated, verapamil,versatile,. Cryselle",,Thyroid problem,,"Azithromiacine, latex.","['Arthralgia', 'Asthenia', 'Headache', 'Muscle spasms', 'Myalgia', 'Nausea', 'Neck pain', 'Pyrexia', 'Skin sensitisation']",1,JANSSEN,SYR 1078165,TX,30.0,F,"At routine 38 week doctor appointment, had high blood pressure. Upon re-check, it was still high and also had protein in the urine. Diagnosed with pre-eclampsia despite never having issues with high blood pressure and none of the associated risk factors. Went straight to labor and delivery and upon monitoring, baby was in distress. Heart rate did come back up; she was born that evening by c-section. Original due date was February 5, 2021 (birth date was January 25). Birth weight was 5 lbs 12 oz.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/21/2021,01/25/2021,4.0,PVT,"Prenatal vitamin, baby aspirin",,,,,"['Caesarean section', 'Exposure during pregnancy', 'Foetal distress syndrome', 'Hypertension', 'Pre-eclampsia', 'Premature delivery', 'Protein urine present', 'Proteinuria']",1,PFIZER\BIONTECH,SYR 1078167,CA,61.0,F,"Enlarged lymph left side in arm pit and neck, lower abdominal pain that resulted in Rectus Sheath Hematoma 6 days after second vaccine 2/24/2021. Treated for pain control and administered IV fluids.",Not Reported,,Yes,Yes,1.0,Not Reported,N,02/18/2021,02/24/2021,6.0,PVT,"Celebrex, Synthroid, Lisinopril, Lipitor, Prem-Pro, Valtrex, Singular, Seroquel, D3, Qnasal, Delura,",,"Aspleenic, HBP, High Cholesterol, Neutropenia, Thrombocytosis, Asthma, Allergies, Bipolar, Herpes, Hypothyroid.",,"Codeine, Vicodeine, Tape Adhesives, Bee Venom, Nickel","['Abdominal pain lower', 'Abdominal wall haematoma', 'Computerised tomogram', 'Full blood count abnormal', 'Haemoglobin decreased', 'Lymphadenopathy', 'Scan with contrast']",2,MODERNA,IM 1078182,CA,42.0,M,Moderate soreness at site of injection. Headache Mild fever (99-99.6) Body wide muscle ache Skin touch sensitivity Tiredness Treated with 2 tablets of Extra strength Tylenol,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,PHM,None,None,None,,None,"['Fatigue', 'Headache', 'Injection site pain', 'Myalgia', 'Pyrexia', 'Sensitive skin']",1,JANSSEN,IM 1078184,MA,67.0,M,"sudden flushing of upper body starting around 4PM 3/6/21 - about 50 hrs post-dose - took Benadryl 50mg seemed to diminish some 30-40 minutes later - itch gone, still minor redness on upper chest, shoulders and face",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/06/2021,2.0,OTH,"lisinopril, allopurinol, fluticasone,azelastine, vitamin D, Vit B-12, niacin",,hypertension,,none known,"['Flushing', 'Pruritus']",1,JANSSEN,IM 1078196,FL,73.0,F,"I have developed bell's palsy. I am not sure if that is due to the Pfizer vaccine. Otherwise, I am in excellent health.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/01/2021,03/04/2021,31.0,OTH,None,None,None,,None,"['Angiogram cerebral normal', ""Bell's palsy"", 'Brain scan normal', 'Computerised tomogram head normal', 'Magnetic resonance imaging head normal']",2,PFIZER\BIONTECH,SYR 1078197,CO,61.0,M,"Headache - moderate. Facial numbness - started at the nose, across the bridge of the nose and upper cheeks, then spread to entirety of face. Face is still somewhat numb 55 minutes after symptoms began. Headache also still present.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PVT,"Allupurinol, Testosterone, Acylivir",,Gout,,Morphine,"['Headache', 'Hypoaesthesia']",UNK,JANSSEN,IM 1078198,CA,35.0,F,"Fever, Chills, Body aches, hives 48 hours New onset Rheumatoid Arthritis",Not Reported,,Not Reported,Not Reported,,Yes,N,01/22/2021,01/25/2021,3.0,PVT,Vitamin B Methlyfolate,None,Interstitial Cystitis,,NKA,"['Anti-cyclic citrullinated peptide antibody positive', 'Chills', 'Pain', 'Pyrexia', 'Red blood cell sedimentation rate increased', 'Rheumatoid arthritis', 'Rheumatoid factor increased', 'Urticaria', 'X-ray limb normal']",2,MODERNA,IM 1078200,TX,34.0,F,"Mouth and throat tingling and slight swelling, dizziness, rapid heart beat, shaking, difficulty breathing.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,"Montelukast, Sronyx",None,Asthma,,None,"['Dizziness', 'Dyspnoea', 'Heart rate increased', 'Paraesthesia oral', 'Pharyngeal paraesthesia', 'Swelling', 'Tremor']",1,JANSSEN,IM 1078218,,47.0,M,"About 10 min after the vaccine was administered, the patient suddenly felt hot, dizzy, and his vision became blurred. Resolved after about 2 minutes after removing glasses and drinking water",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/06/2021,0.0,PHM,,,,,,"['Dizziness', 'Feeling hot', 'Vision blurred']",1,JANSSEN,IM 1078231,CO,63.0,M,"mid grade fever, headache, fatigue, mild discomfort at injection site. Fever began approximately 8 hours after injection. Headache persisted for approximately 20 hours after injection. ITC Tylenol alleviated most symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,,Shingles,,,,"['Fatigue', 'Headache', 'Injection site pain', 'Pyrexia']",1,JANSSEN,IM 1078239,MN,77.0,F,Death. Ruptured myocardial infarction.,Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,UNK,"Amlodipine, buspirone",Unknown,"Hypertensive cardiovascular disease with coronary artery disease, cerebrovascular disease",,Unknown,"['Death', 'Myocardial rupture']",2,MODERNA, 1078241,MD,34.0,F,"Chills at 5 pm, rapid breathing followed by nasea arouns 10 pm, vomited once around midnight, naseau until morning, symptoms revealed in morning",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,Caffeine 100mg,Migraines,Migraines,,None,"['Chills', 'Nausea', 'Respiratory rate increased', 'Vomiting']",1,JANSSEN,IM 1078246,MN,76.0,F,Death. Ruptured myocardial infarct.,Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/01/2021,03/01/2021,0.0,UNK,Unknown,Unknown,"Atherosclerotic heart disease, nephrosclerosis",,Unknown,"['Death', 'Myocardial rupture']",1,MODERNA, 1078261,MI,86.0,F,"Patient received 1st dose of vaccine at 3.20pm, was accompanied by the daughter to the observation area . The reporter was at the observation station at that time and did not observe any problems or concerns or changes in behavior. The patient have been sitting the chair and talking to her daughter. In about 20-25 minutes a daughter complained that her mother felt a little faint. Vitals have been taken and it was noted that level of patient's SpO2 was dropping to 88. Blood pressure was 140/100 which was normal for the patient according to the daughter and pulse was 65. The patient was connected to 4L of oxygen and her saturation improved, however, as soon as the oxygen was weaned, the patient had drops in saturation. Ambulance have been called and EKG have been performed. The patient has a history of A fib. After 30 minutes of monitoring the patient have been transported to the hospital with the BP 150/110 and SpO2 88. Patient stated she felt fine and did not have any concerns. the daughter said that the vaccination was a first major event for her mother since last year and she have been very excited about this.",Not Reported,,Not Reported,Yes,,Not Reported,U,03/06/2021,03/06/2021,0.0,OTH,Pravastatin (20mg) Mirtazapine (7.5mg) Metoprolol (25mg) Lozartan (25mg) Cholecalciferol (50mcg),"Hypertension, A-fib, hyperlipidemia, OSA, CKD, gout, primary osteoarthritis, dementia, depression","S/p cholecystectomy, S/p bilateral cataract extraction, s/p lumbar spinal fusion, hearing loss, osteoporosis,",,"Allopurinol analogues, sulfonamide antibiotics","['Dizziness', 'Electrocardiogram', 'Oxygen saturation decreased']",1,PFIZER\BIONTECH,IM 1078273,MN,25.0,M,"Body chills 8 hours after receiving vaccine. 2 hours after that, fever of 103 F and severe headache. Took 1000mg of ibuprofen. The next day fever was about 100F, headache was mild, slight nausea, tired feeling.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PUB,,,,,,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia']",1,JANSSEN,SYR 1078276,FL,57.0,F,"I began running a fever 3/2 of 101, notice swelling in lymph nodes on right side of neck. Trouble swallowing. Fever escalated to 103 at 1am 3/3. By 9am 3/3 neck was much more swollen and swallowing more difficult. By 3/4 fever down to 101.3 but throat so swollen difficult to talk, drink, unable to eat. Went to ER at 3:30pm 3/4.",Not Reported,,Yes,Yes,2.0,Not Reported,N,03/01/2021,03/02/2021,1.0,OTH,Estring2mg,None. The above date was my 2nd vaccine dose,None,,"Keflex, beef, cats","['Abscess neck', 'Blood test', 'Computerised tomogram', 'Dysphagia', 'Electrocardiogram', 'Feeding disorder', 'Fluid intake reduced', 'Lymphadenopathy', 'Pharyngeal abscess', 'Pharyngeal swelling', 'Pyrexia', 'Speech disorder']",2,PFIZER\BIONTECH,SYR 1078292,IN,53.0,M,"Low grade fever99.0, chills, headache, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,OTH,"Zinc, vitamin c, multi vitamin, vitamin D3, singular, glucosamine, baby aspirin",None,Asthma,Shingles,None,"['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,JANSSEN, 1078313,VA,77.0,F,"03/05/21 - 6 p.m. - severe throbbing headache lasting all night, cold (no fever) 03/06/21 - 8 a.m. - weakness , sense that blackout very possible 03/06/21 - 9 a.m. - severe lower back pain lasting entire day and into evening, difficultly moving",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,PUB,Thyroid supplement,None,"Arthritis, celiac disease, spinal stenosis",,Multiple drug sensitivities,"['Asthenia', 'Back pain', 'Dizziness', 'Feeling cold', 'Headache']",UNK,JANSSEN,SYR 1078314,OH,63.0,M,"Pt was held for 15 minutes. Past 15 minutes, patient was ready to leave but complained of nausea. Asked pt to stick around. Took blood pressure. It was low ~90/55. Asked again how he was doing, stated okay but feeling chills/cold. Started to shake uncontrollably. Ask pt if he thought a hospital visit was necessary; he stated no at that time. Decision was made to call squad; BP was elevated now and still shaking. Transported at that time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,Not known. Patient was not a customer of pharmacy at the time of admin.,"Pt stated a cut on finger which he was taking antibiotics for; however, no other issues within last month.",Pharmacy unaware of health conditions. Pt has omitted that from intake form. No previous care given to pt at time of incident.,,NKDA,"['Anxiety', 'Chills', 'Feeling cold', 'Hypotension', 'Nausea', 'Panic attack', 'Tremor']",1,JANSSEN,IM 1078320,CA,68.0,F,"I had chills, muscle aches, and I fainted when I got up to the bathroom, breaking my ankle.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/25/2021,02/26/2021,1.0,PVT,Insulin,None,Diabetic (type 2),,None,"['Ankle fracture', 'Chills', 'Myalgia', 'Syncope']",2,MODERNA,SYR 1078324,CO,24.0,F,"Severe chills after 7 hours, terrible headache, ?brain zaps,? nausea, fever of 103.5 around 12am, after 2 hours of sleep. Took tylenol and ibuprofen, drank lots of water, felt better by 10am. The pain was intense and I feared a bad reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PHM,Nexplanon insert into left arm Paxil 30 Wellbutrin 50 Gabapentin 400 Levothyroxine .05 Spironolactone Doxycycline Tretinoin cream .05% Sulfacetamid 10% Vit D,None,Depression and anxiety Acne,,Unknown,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",,JANSSEN,SYR 1078344,IL,52.0,F,"fever, chills, achiness, dizziness, diarrhea, fast heartbeat Side effects began about 8:00 pm, about 9 hours after receiving the injection. Symptoms treated with ibuprofen and rest at home. Symptoms improved the next day. By 5:00 pm on 3/6/21, just fatigue remains.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,"Multi-vitamin chewables, Mili tablets (norgestimate and ethinyl estradiol tablets USP), Nitrofurantoin Macro 50mg capsules",,obesity,,,"['Chills', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Heart rate increased', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1078352,IL,18.0,M,"Developed fatigue, body aches, headache 1 day after vaccination on 3/3. The morning of 3/5 complained of chest pain. Took Tylenol at 8:30 am. At 10:30 am his family found him unresponsive. EMS was called and he was pronounced dead in the home.",Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/02/2021,03/05/2021,3.0,PVT,,,,,,"['Chest pain', 'Death', 'Fatigue', 'Headache', 'Pain', 'Unresponsive to stimuli']",1,MODERNA,IM 1078376,NY,33.0,M,"Fever, body aches, headache, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,OTH,Finasteride 1mg Sertraline 100mg Bupropion 300mg Truvada 100mg,,,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1078379,WI,33.0,F,This is my 2nd pregnancy. Due date of 06/10/21. After the 2nd shot I developed hives on my right arm and in my inner thighs. An ultrasound 6 days after my 2nd injection showed an umbilical vein varix on baby.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/23/2021,6.0,PVT,Prenatals,Moderna arm with first vaccination,None,,Na,"['Exposure during pregnancy', 'Foetal exposure during pregnancy', 'Injection site urticaria', 'Ultrasound antenatal screen abnormal', 'Umbilical cord abnormality', 'Urticaria']",2,MODERNA,IM 1078389,VA,66.0,F,"After roughly 4 hours I started to get chills and body aches. I went to bed but could not get warm and writhed in considerable distress for at least an hour. (This was the most uncomfortable I've been since induced labor before the anesthesiologist arrived for an Epidural 28+ years ago.) My temperature fell to 95 before I took acetaminophen and was able to fall asleep.. Now, at 7 hours it's 101.2 and I'm just getting the side effects I expected: weakness, a little nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PUB,Simvastatin 20 mg,,,,"Penicillin, Ampicillin, Clindamycin: Rash Beets: Genital itch","['Asthenia', 'Body temperature decreased', 'Body temperature increased', 'Chills', 'Emotional distress', 'Nausea', 'Pain']",1,JANSSEN,IM 1078413,TX,37.0,M,"Fever, Fatigue, Nausea, loss of appetite, muscle and joint aches and soreness, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,OTH,None,None,None,,None,"['Arthralgia', 'Decreased appetite', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",1,JANSSEN,IM 1078418,MN,65.0,F,"Janssen COVID-19 Vaccine EUA About 8 hours after the injection, I started having strong chills. About 10 hours after, I started having an incredibly fast heartbeat that lasted for about 10 hours. I tried some breathing exercises to bring it down, but that did not work. I did not seek medical care as it went back to normal throughout the morning of the following day. But kind of scary. Also had a low temperature of 98 on the scanner thermometer. Normal is 96 something.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PVT,"hydrochlorothiazide, multi-vitamin, low dosage aspirin, fish oil, calcium with vitamin D, fasomax",none,"high blood pressure, osteopenia",,Zyrtec,"['Chills', 'Heart rate increased']",1,JANSSEN,SYR 1078424,NM,72.0,M,"fever, chills, headache for 12 hours. Fatigue continues.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,UNK,,,,,,"['Fatigue', 'Feeling cold', 'Headache', 'Pyrexia']",UNK,JANSSEN, 1078426,CO,63.0,F,"Immediate drop in blood sugar, lower than 70. I am diabetic. Drank juice for rescue at the site.",Not Reported,,Not Reported,Yes,,Not Reported,Y,03/06/2021,03/06/2021,0.0,UNK,,,,,,"['Blood glucose decreased', 'Diabetes mellitus', 'Immediate post-injection reaction']",1,MODERNA,IM 1078440,CA,19.0,M,Patient presented about 5 minutes post vaccination with dizziness and nausea. Patient maintained consciousness and did vomit slightly. After about 15 minutes the patient did feel better and left the pharmacy.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,,,,,,"['Dizziness', 'Nausea', 'Vomiting']",1,JANSSEN,IM 1078458,VA,31.0,F,Blood clot in lung,Not Reported,,Yes,Yes,1.0,Not Reported,N,02/22/2021,02/26/2021,4.0,PVT,,Polyp in uterus,,,Mango,"['Computerised tomogram', 'Fibrin D dimer', 'Pulmonary embolism']",2,PFIZER\BIONTECH,SYR 1078464,CA,91.0,M,"My birthfather had an adverse reaction after he got his 1st Moderna COVID vaccine. He lives alone and was doing well with some underlying conditions. The day of the shot was fine. The next AM, he had vision changes and sudden numbness in his R arm/leg and fell after getting up. ?The numbness went away pretty quickly, but the visual changes remained. He refused to go to the ER/Dr. The next week and a half, he was weak, tired, and couldn?t think as clearly. ?He was brought to the ER? on Wed, 3/3/21 at Hospital. He was found to have a low oxygen level, possible a-fib, fluid retention, emphysema, and aortic stenosis, in addition to his other health issues. ?The Dr said his symptoms the day after the vaccine were a mini-stroke.. He was released from the hospital on Friday, 3/5/21. On Saturday, Hospice came to see him, since nothing can be done for his medical conditions; however, they decided not to sign him up yet, since he I was told they didn't feel he needed to, at this time. One of my sisters is staying with him during the day until he builds his strength back up. Do you think his Mini stroke and health changes had anything to do with the vaccine? He will not be getting the second COVID shot. ?We?re all caught between a rock and a hard place as far as what to do, esp for older folks.",Not Reported,,Yes,Yes,2.0,Yes,U,02/18/2021,02/19/2021,1.0,SCH,Not sure,"Prior to vaccination, he had no illness.","Prior to vaccination, he had history of carotid artery blockage on one side, poor circulation in both legs, poor kidney function, high BP and cholesterol. He has lactose intolerance.","Yes, to Polio as a teenager. became faint",Not sure,"['Aortic stenosis', 'Asthenia', 'Echocardiogram', 'Emphysema', 'Fall', 'Fatigue', 'Fluid retention', 'Hypoaesthesia', 'Laboratory test', 'Mental impairment', 'Oxygen saturation decreased', 'Transient ischaemic attack', 'Visual impairment']",1,MODERNA, 1078485,FL,46.0,F,"Extreme headache, joint aches (especially hips), nausea, fatigue, fever 102.3, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/05/2021,1.0,OTH,Levothyroxine,None,Hypothyroidism,,None,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia']",1,JANSSEN,SYR 1078505,TX,29.0,F,Chills and 101.7 fever,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,UNK,,,,,,"['Chills', 'Pyrexia']",1,JANSSEN,SYR 1078511,IN,57.0,F,"Developed fever several hours after injection and high fever at night (103.1 degrees). This is second night and still has a fever of (101.7 degrees). Body aches, sweats, and soreness.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,PUB,Prilosec,"tested positive to Covid on December 15, 2020",Scleroderma,,none known,"['Hyperhidrosis', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1078543,NY,38.0,M,"Mild fever around 100 degrees, severe chills, headache, fatigue, sore arm at injection site. Ongoing from around 7pm so about 2 hours at this point. Arm felt a bit sore for the first time around 2pm today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,OTH,"Metformin, ozempic, and claritromicine",Diabetes,Diabetes,,Allergic to bees,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pyrexia']",1,JANSSEN,SYR 1078570,MD,40.0,M,"High moderate myalgia, fatigue, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/05/2021,03/05/2021,0.0,OTH,,,,,,"['Fatigue', 'Myalgia', 'Pyrexia']",1,JANSSEN,IM 1078576,CO,21.0,F,"Fever, chills, headache, vomiting, cramps",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/05/2021,03/05/2021,0.0,PHM,Birth control,UTI,No,,No,"['Chills', 'Headache', 'Muscle spasms', 'Pyrexia', 'Vomiting']",,JANSSEN,SYR 1078588,CO,50.0,F,"Headache, nausea, chills, fever, hives, (within 5 hours) facial swelling ( right side) itching (1 day later)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,OTH,Low Does Naltrexone Wellbutrin Prozac,,,,,"['Chills', 'Headache', 'Nausea', 'Pruritus', 'Pyrexia', 'Swelling face', 'Urticaria']",1,JANSSEN,IM 1078592,IL,25.0,F,"Violent muscle aches that were not settled by medication, far beyond normal muscle aches from illness. Began exactly 6 hours following vaccine and continued for approximately 12 hours. Fever for 24 hours. Fatigue, black outs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,UNK,Lamictal Ortho Tri Cyclen Lo,None,None,,Penicillin,"['Fatigue', 'Loss of consciousness', 'Myalgia', 'Pyrexia']",1,JANSSEN,SYR 1078602,,21.0,F,Chills Fever/flush Periods of being cold then being incredibly hot Weakness/soreness of muscles Dizziness Headache/sinus pressure,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,UNK,Fluoxetine HCl Birth Control,None,None,,None,"['Asthenia', 'Chills', 'Dizziness', 'Feeling cold', 'Feeling hot', 'Flushing', 'Headache', 'Myalgia', 'Paranasal sinus discomfort', 'Pyrexia']",UNK,JANSSEN,IM 1078609,NY,64.0,F,Needle was missing from syringe. Not sure if it retracted back into syringe or in patients arm,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/06/2021,0.0,OTH,,,,,,['Product administration error'],1,JANSSEN,IM 1078618,CT,84.0,F,"She was week, fell, wouldn't eat, drink or get out of bed. Died after being sent to hospital 3 times and ended up on hospice",Yes,02/07/2021,Not Reported,Yes,3.0,Not Reported,N,01/19/2021,01/25/2021,6.0,SEN,,,"Alzheimer , high cholesterol",,,"['Asthenia', 'Death', 'Decreased appetite', 'Fall', 'Food refusal', 'Mobility decreased']",UNK,PFIZER\BIONTECH,SYR 1078623,NY,69.0,F,Nausea Headache Body ache Temperature 100.2,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/05/2021,03/06/2021,1.0,PVT,Zocor 5mg Evening Metformin 500mg Twice A Day Bayer Aspirin 81mg Night Time,No,Osteoarthritis,,Zithromax Shell Fish Nuts,"['Body temperature increased', 'Headache', 'Nausea', 'Pain']",1,JANSSEN,IM 1078631,NY,52.0,F,"Fever, nausea, chills, headache, body pain more in the right side of my body. I had the vaccine in the left side. I was feeling very tired.I started feeling better 24hrs after the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/05/2021,1.0,OTH,"Cozaar 100mg, Norvasc 2.5mg Glimeriperide 4mg",Back muscle spam,"High blood pressure, asthma and diabetes",,None,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",UNK,JANSSEN, 1078636,CA,76.0,M,"Severe onset of autoimmune vasculitis and renal failure. Loss of movement & sensation (paralysis) of left arm and leg. Mild cognitive deficit and confusion. Fell due to loss of use of L leg. Hospitalized x 5 days, now in rehab facility slowly regaining function of L arm and leg, and relearning how to walk. Sudden renal failure (stage 4 renal disease) onset suddenly as well with this reaction.",Not Reported,,Yes,Yes,5.0,Yes,N,02/17/2021,02/21/2021,4.0,PUB,None,Celiac Disease BPH (benign prostatic hyperplasia),Celiac Disease BPH (benign prostatic hyperplasia),,Gluten/Celiac,"['Antineutrophil cytoplasmic antibody positive', 'Antinuclear antibody positive', 'Biopsy kidney abnormal', 'Blood creatine phosphokinase normal', 'Blood lactate dehydrogenase increased', 'Blood urine present', 'C-reactive protein normal', 'Chronic kidney disease', 'Cognitive disorder', 'Computerised tomogram head abnormal', 'Confusional state', 'Fall', 'Full blood count', 'Glomerular filtration rate', 'Glomerulonephritis', 'International normalised ratio normal', 'Magnetic resonance imaging neck', 'Metabolic function test abnormal', 'Mobility decreased', 'Monoplegia', 'Neutrophil count increased', 'Protein urine present', 'Prothrombin level normal', 'Red blood cell sedimentation rate increased', 'Renal failure', 'SARS-CoV-2 test negative', 'Sensory loss', 'Troponin normal', 'Ultrasound kidney normal', 'Urine analysis', 'Vasculitis']",2,MODERNA,IM 1078645,TX,39.0,F,"Tiredness, muscle pain, fever (101.8), elevated heart rate (110bpm)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PHM,None,None,,,None,"['Fatigue', 'Heart rate increased', 'Myalgia', 'Pyrexia']",UNK,JANSSEN, 1078647,MD,67.0,F,Headaches for 2 days at the time of this submission,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/05/2021,03/05/2021,0.0,UNK,"Metformin; Lisinopril; calcium, Vitamin D, Vitamin C,",None,Diabetes; high blood pressure,,None,['Headache'],1,JANSSEN, 1078654,WA,91.0,F,Pt received the vaccine around 1200 PM. Around 1400 pt lost consciousness and became unresponsive and hypotensive with systolic BP at 90 per EMS. Pt was unconscious and unresponsive for approximately 10-15 minutes. Pt regained consciousness spontaneously and her BP slowly returned to normal over the next 3 hours.,Not Reported,,Not Reported,Yes,1.0,Not Reported,U,03/06/2021,03/06/2021,0.0,PVT,Aspirin 81 mg,None known,hypertension.,,Sulfa antibiotics,"['Brain natriuretic peptide', 'Chest X-ray', 'Computerised tomogram head', 'Full blood count', 'Hypotension', 'Laboratory test', 'Loss of consciousness', 'Metabolic function test', 'Troponin', 'Unresponsive to stimuli', 'Urine analysis']",1,PFIZER\BIONTECH,IM 1078664,OR,65.0,M,"Fever, chills, body aches, headache, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,OTH,"Atorvastatin, metoprolol, vitamin D3, spironolactone, tamsolosin, omeprazole, aspirin",None,"Heart disease, BPH, achalasia",,None,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1078680,NY,60.0,F,pt had elevated blood pressure that persisted. bp 20/114 and repeat 5 min later 232/126,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/06/2021,0.0,UNK,lisinopril,,HTN,,,['Blood pressure increased'],1,JANSSEN,IM 1078688,NY,52.0,F,"Itchiness and redness on face , neck, chest.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,None,None,"Breast cancer, asthma, overweight/obese",,"Ibuprofen, sulfa drugs, codeine, levaquin/levofooxacin, latex, octopus ink.","['Erythema', 'Pruritus']",1,JANSSEN,IM 1078690,WA,41.0,F,"Chills, muscle pain and low fever",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/06/2021,0.0,WRK,"Timolol, zioptan. , alphagan. Ropressa, Adrenalin support vitamins",No,Severe glaucoma,,No,"['Chills', 'Myalgia', 'Pyrexia']",1,JANSSEN,SYR 1078696,NY,71.0,F,"Pt developed a rash on her finger that spread to her wrist. Benadryl 25mg was given.. the rash improved. Pt blood pressure elevated 195/113, repeat 207/117. Pt developed nausea and abdominal pain. Pt was transported to the ER",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/06/2021,0.0,UNK,,,"asthma, htn",,,"['Abdominal pain', 'Blood pressure increased', 'Nausea', 'Rash']",UNK,JANSSEN, 1078714,NE,28.0,F,"Fever, arm pain. Tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/06/2021,0.0,SCH,Tylenol,,,,,"['Pain in extremity', 'Pyrexia']",1,JANSSEN, 1078716,OH,57.0,M,Extreme Chills took 2 Advil at 9:00 pm and 2 more at 11:00 pm on 03/06/2021. Fever 101.5 took 2 Advil at 1:30 am on 03/07/2021 - current. Flu like aches started at about 9:00 pm on 03/06/2021 - current.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/06/2021,0.0,PVT,"insulin lispro 100 unit/mL Soln by closed loop system, metoprolol succinate 1� x 25 mg XL tablet, lisinopriL 10 mg tablet, atorvastatin 20 mg Tab, fluticasone propionate 50 mcg/actuation nasal spray, MULTIVITAMIN PO, aspirin 81 mg PO tablet",None Known,"Type I Diabetes, Nasal Allergies",,None Known,"['Chills', 'Influenza like illness', 'Pyrexia']",1,JANSSEN,SYR 1078718,NY,40.0,F,Fever of 104 Fatigue Headache Body aches Chills Nausea Neck pain,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,UNK,None,None,Asthma High blood pressure,,None,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Neck pain', 'Pain', 'Pyrexia']",UNK,JANSSEN,SYR 1078726,TX,29.0,F,"Headache, chills, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,UNK,,,,,,"['Chills', 'Headache', 'Pain']",UNK,JANSSEN, 1078729,FL,39.0,F,Woke up a chills Nd a fever of 102. This is higher than I had when I had Covid.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/01/2021,03/07/2021,6.0,PHM,XolAir and antihistamines,No,CIU and suspected mast cell disorder. I also had Covid 9/20,,Sulfa drugs- anaphylaxis,"['Chills', 'Pyrexia']",UNK,JANSSEN, 1078735,NY,35.0,F,"WHEN I ADMNISTERED THE VACCINE, 2 DROPLETS CAME BACK AND DRIP OFF THE ARM .",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/07/2021,0.0,OTH,UNKNOWN,NONE,NONE,,NKA,['Incorrect dose administered'],1,JANSSEN,IM 1078744,MN,32.0,F,"body aches, back pain, vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/06/2021,0.0,PVT,"amlodipine, buspirone, citalopram, hydrochlorothiazide, cholecalciferol",,,,"Bees, CT contrast, egg white","['Back pain', 'Full blood count', 'Laboratory test', 'Pain', 'Vomiting']",1,JANSSEN,IM 1078745,,28.0,M,"Chills, and fever that spiked as high as 102.7 Degrees F....",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,,,Hypertension Obesity,,"Iodine contrast, shellfish","['Chills', 'Pyrexia']",UNK,JANSSEN, 1078759,IN,56.0,F,"tingling, left side (still exists two days post shot) Chills (severe night of shot, ended early next morning) Body aches (severe night of shot, ended early next morning) Mild body sore Headache (still exists two days post shot)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,OTH,Hydrochlorothiazide Losartan,Had Cataract Surgery,High Blood Pressure,,None,"['Chills', 'Headache', 'Pain', 'Paraesthesia']",1,JANSSEN,SYR 1078763,NJ,28.0,F,"Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,,,,,,"['Dizziness', 'Flushing', 'Hyperhidrosis']",1,JANSSEN,IM 1078765,NY,53.0,M,"Systemic: Fainting / Unresponsive-Mild, Systemic: Patient passed out and recovery after 40 seconds of chest compression-Mild, Additional Details: Patient was seen rocking back and forth in his chair according to 3 observers in the room, then fell back hit his head after observed his face turned pale. 3 Observers rushed over to him, patient was not breathing, unconscious and not responsive, eye ball stiff, sweating but cold. Eyelid peeled back and the eye is responsive to light. Started chest compression immediately and after 40 seconds of chest compression at third round, patient came back. no hx of preexisting condition or allergies note",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,WRK,,,,,,"['Fall', 'Head injury', 'Hyperhidrosis', 'Loss of consciousness', 'Nasopharyngitis', 'Pallor', 'Respiratory arrest', 'Resuscitation', 'Syncope', 'Unresponsive to stimuli']",1,JANSSEN,IM 1078769,PA,24.0,F,"Systemic: Nausea-Mild, Systemic: Vomiting-Medium, Additional Details: Pt was uneasy about needles and vomited about 2 minutes after administration. Pt also had some mild nausea. Pt was monitored for 30-45 minutes before leaving pharmacy when she felt normal and fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,,,,,,"['Nausea', 'Vomiting']",1,JANSSEN,IM 1078772,MA,39.0,F,"Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Additional Details: Patient felt faint immediately upon receiving the vaccination. received instruction to sit down. upon sitting down patient passed out/fainted/ muscle contractions in both hands were observed. 911 emergency services were contacted. patient then taken into ambulance for further evaluation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/06/2021,0.0,PHM,,,,,,"['Dizziness', 'Flushing', 'Hyperhidrosis', 'Hyperventilation', 'Loss of consciousness', 'Muscle tightness', 'Nausea', 'Syncope', 'Tremor']",1,JANSSEN,IM 1078775,MA,37.0,F,"Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fained a few minuies after injection. Felt hot then tried to get up and fell to the ground. She was not injured. EMS was called and evaluated her. No signs of anaphylaxis.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,,,,,,"['Dizziness', 'Fall', 'Feeling hot', 'Flushing', 'Hyperhidrosis', 'Syncope', 'Unresponsive to stimuli']",1,JANSSEN,IM 1078776,MA,36.0,M,"Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: While sitting for 15 minute observation period, patient was experiencing lightheadedness and sweating. He was instructed to take deep breaths and take oral fluids, to which he stated that he started to feel better immediately. He was instructed to sit for a 30 minute observation period at the end of which he stated that he felt completely fine. He was given instructions on what to do if he experiences any other adverse effects and also given a pharmacy business card with phone number.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,,,,,,"['Dizziness', 'Flushing', 'Hyperhidrosis']",1,JANSSEN,IM 1078777,CA,62.0,M,"Systemic: Fainting / Unresponsive-Medium, Systemic: Fainted but seems responsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient fainted from sitting after vaccination. No difficulty breathing/swallow, thus gave water and gatorade. He was responsive to my questions. He has history of anxiety to needles and he did not eat lunch before vaccine. He stayed seated for 1 hour to monitor. Then, walked an aisle before driving home. Asked him to eat first before driving home. Called him twice and he is home and feeling okay. Counseled to call pharmacy if any symptoms of allergic reaction to vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,,,,,,"['Flushing', 'Hyperhidrosis', 'Syncope']",1,JANSSEN,IM 1078778,NY,46.0,M,Marked soreness and aches of all major muscles.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/06/2021,0.0,PUB,"Celexa, simvistatin, lisinopril",None,"Obesity, hypertension, high cholesterol",,None,['Myalgia'],1,JANSSEN, 1078780,CA,49.0,F,"Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: TOOK PATIENT'S VITALS TWICE, FIRST WAS BP 100/74 HR 64, SECOND BP 105/76 HR 71, FOLLOWED UP WITH PHONE CALL TO PATIENT AFTER 2 HOURS AND SHE WAS FEELING BETTER",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,,,,,,"['Dizziness', 'Flushing', 'Hyperhidrosis', 'Nausea']",1,JANSSEN,IM 1078782,NY,47.0,F,"Fever, chills, headache, body aches, numbness and tingly feeling in all finger tips",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PUB,Allegra,None,None,,Nickel,"['Chills', 'Headache', 'Hypoaesthesia', 'Pain', 'Paraesthesia', 'Pyrexia']",1,JANSSEN,SYR 1078786,VA,69.0,F,"mild itching, headache, and very tired. I di not take an antihistamine or pain med for the headache. I di sleep about 10 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,"Lisinopril 10, Pravastatin 10 mg, Probiotic tablet, Vitamin B complex, Vitamin D, Cranberry tablet",bladder infection,"mild high blood pressure, borderline high cholesterol",years ago from a flu vaccine. I broke out in hives.,"seasonal allergies, sensitivity to antibiotics (recently, Cipro, Doxycyline, Nitrofurantoin)","['Fatigue', 'Headache', 'Pruritus']",1,JANSSEN,IM 1078789,MA,65.0,M,"I had all the side effect system, fever, chills, fatigue muscle and joint pain. The joint pain is what I would like to share my concern about. A little more than a year ago (Feb 2020) I have L4/L5 fusion surgery. The surgery was successful and for the last six month had little to no pain (no more than a 1 on the pain scale). Saturday a day after the vaccination my lower back pain was significant (5 to 6 on the pain scale). I am not sure if this was just a coincidence but thought it was worth reporting. Today, Sunday March 7th the pain is much better (about a 2 on the pain scale and I think will completely go away as I move around more and loosen up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/06/2021,1.0,SCH,"lisinopril, simvastatin, acetominaphen",none,high blood pressure and cholesterol,,none,"['Arthralgia', 'Chills', 'Fatigue', 'Myalgia', 'Pyrexia']",UNK,JANSSEN, 1078795,NC,56.0,F,"Severe chills, low fever and racing heart. The heart rate almost got me to the hospital. 112 BPM. Symptoms lasted until early morning but then went away.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,ibrupropin and asprin,none,"obese, chronic cough",,none,"['Chills', 'Palpitations', 'Pyrexia']",1,JANSSEN,IM 1078801,LA,59.0,F,"In addition to the muscle ache, headache & fatigue I had extreme chills with shakes and fever of 37.7c. Fever didn't respond to Tylenol but it did to Advil. As morning came fever has returned and has responded to Tylenol so far.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,OTH,"Losartan, Nifedipine, vitamin D, Metoprolo. Cummin with ginger, biotin",None,"High blood pressure, arthritus","Extreme Fever, when getting vaccines to leave the country when I was an infant",Sulfur drugs,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia', 'Tremor']",1,JANSSEN,IM 1078812,CO,28.0,M,Frequent urination Insomnia ( unrelated to frequent urination) Feelings of severe dehydration Muscle ache Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,OTH,None,None,Asthma,,None,"['Headache', 'Insomnia', 'Myalgia', 'Pollakiuria', 'Thirst']",1,JANSSEN,IM 1078813,NY,59.0,M,"Chills, back ache, elevated pulse(115) started about 12 hours after vaccination. Lasted about 8 hours. Called cardiologist and he said it was probably a reaction to the vaccine. Took some ibuprofen. Did not do anything else. Felt better the next morning and pulse was fluctuating between 80 and 90.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,"Metformin,Rosuvastatin,,Tamsulosin,Amlodipine Besylate,Benazepril-HCTZ,vitamin D,multi vitamin",None,"High cholesterolm high blood pressure,elevate H1C,enlarged prostate",,None,"['Back pain', 'Chills', 'Heart rate increased']",1,JANSSEN,IM 1078816,VA,31.0,F,"Headache, tired and exhausted, feeling weak, muscles ache, left arm feels sore. Night time the chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,SCH,None,None,None,,None,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pain in extremity']",1,JANSSEN,SYR 1078820,SC,50.0,F,"Fever, chills, migraine, increased heart rate for an extended period of time, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PHM,"Eloquis, synthroid, vitamin D",,"Heart arrhythmias, history of Afib, Hypothyroidism",,,"['Chills', 'Heart rate increased', 'Migraine', 'Pain', 'Pyrexia']",UNK,JANSSEN,SYR 1078828,NC,38.0,M,"Headache, fever, chills, muscle aches, fever, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/06/2021,1.0,SCH,Lisinopril,None,None,,None,"['Chills', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",UNK,JANSSEN, 1078837,NJ,68.0,F,"Ten days after the first shot and four days after the second shot I experienced two episodes of chest tightening, increased heart rate, and pain that radiated around to my back. Each episode lasted about 15 minutes. During the second episode, I checked my heart rate on my watch. It was 110+.(I forgot to do it the first time) Both times I was sitting down doing a jigsaw puzzle . Not exactly stressful or physically taxing.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/25/2021,02/28/2021,3.0,OTH,"Synthroid, Evista, Lipitor, methotrexate, folic acid, prednisone, time release melatonin, vitamin D, CoQ10, calcium",none,"Hashimoto's thyroid, Vitiligo, Rheumatoid arthritis",,"penicillin, erythromycin, Bactrain, cephalosporin","['Back pain', 'Blood test normal', 'Cardiac stress test normal', 'Chest X-ray normal', 'Chest discomfort', 'Echocardiogram normal', 'Electrocardiogram normal', 'Heart rate increased', 'Pain']",1,PFIZER\BIONTECH,IM 1078855,DC,28.0,F,Body aches and chills led to low-grade fever (100 degrees at peak) and headache over the course of midnight to 9:30 a.m. the following day. Treated by hydrating.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,OTH,"Vyvanse, Amphetamine Salts",None,Factor II Prothrombin Blood Clotting Disorder,,None,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1078856,NC,62.0,M,"Muscle ache, headache, fatigue -- essentially severe flu-like symptoms beginning at approximately 10 hours after the injection and lasting for 10 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,UNK,"Bisoprolol (Zebeta) 5MG (R) daily Welbutrin 300MG daily Testosterone Cypionate 200 mg/ml (0.5 mL weekly) Aspirin Tablet, 81MG daily Vitamin D3 50 mcg daily Allegra 100 MG daily",None,None,,None,"['Fatigue', 'Headache', 'Influenza like illness', 'Myalgia']",1,JANSSEN,IM 1078859,VA,65.0,F,"Janssen COVID-19 Vaccine EUA Chills and fever of 103.1 degrees F, elevated heart rate (average 91 bpm) during the night of 3/6/21; Sneezing, runny nose. Treated with Ibuprofen and symptoms resolved by morning of 3/7/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PUB,"Vitamins D, C, K, B6, B complex, Alpha Lipoic Acid, NAC, Copper glycinate, Niacin Estrogen, DHEA, Testosterone",None,Psoriasis,,None,"['Chills', 'Heart rate increased', 'Pyrexia', 'Rhinorrhoea', 'Sneezing']",1,JANSSEN,IM 1078860,OH,63.0,M,"Patient woke up at 4am with shortness of breath, pulse ox 75 on 3.5L oxygen. No improvement with increased oxygen so patient was transported by ambulance to the hospital. When patient arrived to hospital heart rate was over 200.",Not Reported,,Not Reported,Yes,,Not Reported,U,03/05/2021,03/06/2021,1.0,PHM,"Eliquis 5mg, Aspirin 81mg, glimepiride 2mg, metformin 500mg, folic acid 1mg, omeprazole 20mg, losartan 100mg, cabergoline 0.5mg, gabapentin 100mg, carvedilol 25mg, Symbicort 160/4.5, lorazepam 0.5mg, thiamine 100mg, Vitamin D3 1000 units, V",Covid diagnosis1/18/2021,Atrial fibrillation Type 2 diabetic Cardiovascular disease high blood pressure,,none,"['Dyspnoea', 'Oxygen saturation decreased', 'Tachycardia']",1,MODERNA,IM 1078867,OH,35.0,F,"Fever of 101.7, muscle aches, headache, scratchy and sore throat, very tired. I'm 31 weeks pregnant, pregnancy has been normal, estimated date of delivery is May 6th 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,"Bupernorphine, prenatal vitamins",None,None,,None,"['Exposure during pregnancy', 'Fatigue', 'Headache', 'Myalgia', 'Oropharyngeal pain', 'Pyrexia', 'Throat irritation']",1,JANSSEN,IM 1078871,NY,55.0,M,"High fever, weakness, chills, nauseous. Started at 10am. Was hyperventilating trying to vomit but couldn't took Pepto-Bismol. Fell asleep about 3pm woke up at 630pm soaked from fever breaking. took temperature then was 101.7. Still have fever of 100.7 at 10am 3.7.21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,UNK,"5mg rosuvastatin, centrum silver vitamin, turmeric, fish oil, ashwagandha, chantix",,,,penicillin,"['Asthenia', 'Chills', 'Hyperventilation', 'Nausea', 'Pyrexia']",1,JANSSEN,SYR 1078878,VT,20.0,M,"Back pain, leg pin, arm pain(both arms) a headache and weakness and sleepiness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,UNK,,,,,,"['Asthenia', 'Back pain', 'Headache', 'Pain in extremity', 'Somnolence']",1,JANSSEN,SYR 1078890,MN,57.0,F,"Headache, fever, nausea, muscle aches, higher resting heart rate",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,PVT,None,Migraines,Intermittent migraines,,None,"['Headache', 'Heart rate increased', 'Myalgia', 'Nausea', 'Pyrexia']",1,JANSSEN,SYR 1078893,VA,68.0,F,"headache, dizziness, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,UNK,,,,,NKA,"['Dizziness', 'Headache', 'Nausea']",UNK,JANSSEN, 1078895,FL,65.0,M,"Began feeling very weak with a constant headache that later led to blurry vision on March, 2, 2021. On the morning of March 4, 2021, I was still experiencing a right sided headache as well as double vision. I was no longer able to drive at that point. I took my blood pressure digitally at the local pharmacy twice where it was 200/104. I went home to call my physician and also have my wife take my blood pressure manually. My blood pressure at that time was 214/106. I went to the hospital where they examined me and then discharged me with a General Headache without a know cause. I contacted my PCP and he advised me to quadruple my Lisinopril until my BP came down to normal range and see him the morning. My visit the next day showed an elevated blood pressure, double vision, and a continuing headache. My meds were adjusted to Lisinopril 10 mg qd and an addition of Norvasc 5 mg qd. Later that day my blood pressure was down, but still not in the normal range. The following day, March 6, 2021, I was still having the same issues despite the changes in medication. I took my blood pressure at 6 pm and it was 199/104. I immediately went to another hospital where I was admitted as a ""stroke alert"" patient in hypertensive emergency. I am presently being followed as an inpatient in order to get these issues under control.",Not Reported,,Yes,Yes,2.0,Not Reported,N,02/26/2021,03/02/2021,4.0,PUB,Lisinopril 5 mg qd Rosuvastatin 20 mg qd Metformin 1000 mg qd Fish Oil 1000 mg qd Aspirin 25 mg qd,None,Non insulin dependent diabetes - well controlled with Metformin Borderline hypertension - well controlled for many years with Lisinopril Hypercholesterolemia - well controlled with Rosuvastatin,,No food or drug allergies,"['Blood pressure increased', 'Blood test', 'Chest X-ray', 'Computerised tomogram', 'Diplopia', 'Electrocardiogram', 'Glycosylated haemoglobin', 'Headache', 'Hypertensive emergency', 'Impaired driving ability', 'Magnetic resonance imaging', 'Metabolic function test', 'Ultrasound Doppler', 'Vision blurred']",2,MODERNA,SYR 1078900,IA,33.0,F,"Pregnant 17 weeks, Due August 14 2021 Adverse effects: Muscle aches, headache, low grade fever, sore injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,WRK,"Levothyroxine, prenatal vitamin, vitamin D supplement, Probiotic supplement, baby aspirin",,,,Penicillin,"['Exposure during pregnancy', 'Headache', 'Injection site pain', 'Myalgia', 'Pyrexia']",UNK,JANSSEN,IM 1078909,TX,54.0,F,"headache, fatigue, myalgia, chills, muscle weakness (legs gave out while walking)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,None,None,Asthma,,None,"['Chills', 'Fatigue', 'Headache', 'Muscular weakness', 'Myalgia']",1,JANSSEN,SYR 1078918,CT,50.0,F,Body aches Fatigue Headache Running nose Chills,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PVT,Hydrochlorothiazide 25 mg Pimecrolimus Cream 1 %,,Hypertension,,Amoxicillin,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Rhinorrhoea']",1,JANSSEN,IM 1078921,VA,19.0,F,"Fever began around 11pm 3/6/21 and went to 102.3 at about 2:00 am 3/7/21. She had chills for several hours during this time. She felt nauseous, had skin sensitivity, a dry mouth and muscle pain, and felt exhausted. No fever this morning but still some skin sensitivity, nausea and feeling tired, muscle pain, dry mouth, and hot/cold back and forth.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,"Junel birth control pills, melatonin",None,None,,None,"['Chills', 'Dry mouth', 'Fatigue', 'Feeling of body temperature change', 'Myalgia', 'Nausea', 'Pyrexia', 'Sensitive skin']",UNK,JANSSEN,SYR 1078928,VA,44.0,F,"First I got a headache, then I felt extra mucus in my throat. Then I started feeling compression, pressure, and pain in my diaphragm; and then the middle of my chest. Finally, I started coughing, and I wasn't able to breathe. I had told all of the nursing staff that I had anaphylaxis to the first shot, but they acted like they didn't believe me. Also, there was no EMS staff on hand this time, unlike the first time, where they were on site. I think that made the difference in my medical care, because my husband heard the nurses at the facility say they were treating me for anxiety, not anaphylaxis, despite the fact that I was getting worse. The nurses on staff didn't seem to understand or believe that a person could have anaphylaxis from the Covid injection, even though it's on record at the hospital that that's what happened the first time. It wasn't the same staff as last time, which also contributed to the problem. Once the ambulance staff got there, he took me seriously, and finally administered an EpiPen, and also put me on oxygen, which helped a little bit. that was the most comprehensive care I got that day, from someone who was actually listening to me he also took an EKG, which which was normal. When I got to Facility, the treatment wasn't as good as last time, either. Apparently they've been really busy the day before, and all of the staff seemed fatigued because of it. Nobody really checked on me, offered me even ice chips to moisten my mouth, and didn't offer me any assistance in getting to the bathroom, either. a respiratory therapist came in to give me a couple puffs on an albuterol inhaler, and I got a Benadryl shot, but nothing else. I think if I had not taken my coterie of prescriptions to stave off anaphylaxis, it would have been worse. 20 minutes before the shot I took: two aspirin, a CBD capsule, and one each of the following pills -cetirizine, benadryl, famotidine, 20 mg of prednisone, hydroxyzine. I think that's what enabled me to recover with only one EpiPen, instead of two, like last time. if there's a third Moderna shot for the varients, or a booster, I'll try to take all those pills an hour beforehand, and see if having them in my system for a longer period of time we'll make the difference. It will be nice to have *no* anaphylaxis, and skip the hospital trip . Since then, it's taken me about a week to recover fully, the same as after the first shot. I've had problems breathing, fatigue, muscle aches and pains, flushing, fever/chills, and in general just felt like I had the flu.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/26/2021,02/26/2021,0.0,PUB,"Triamterene, Levothyroxine, Vitamin D2, Xopenex HFA, Xopenex Nebulizer tubes, Duoneb, Cetirizine, Nasalcrom, Aspirin, Humalog","I had anaphylaxis after the first shot in January, too","allergies, asthma, anaphylaxis, hypothyroid, diabetic type 2, Lyme disease,fibromyalgia, chronic fatigue, nerve damage in both forearms, demyelination disorder, spinal stenosis, lumbar lordosis, bursitis in both hips, migraines, Lyme arthritis, uterine adenomyosis","I had anaphylaxis to the first moderna shot too. I was still 44, the date was 1.29.21, and it was moderina","latex, lavender, grass pollen, pollen, mold, mildew, bleach, chemicals, fragrances, smoke, aluminum, chlorine, bromine Medications: Fasenra, metformin, sulfa drugs, trileptal, corticosteroids, glucocorticoids, erythromycin, steroids, Singulair, penicillin, amoxicillin, Foods: Swiss cheese, Roquefort cheese, Blue cheese, blueberries, shrimp, sesame seed oil, wheat, yeast, yeast extract, Torula yeast, white chocolate","['Anaphylactic reaction', 'Chest discomfort', 'Chest pain', 'Chills', 'Cough', 'Diaphragmalgia', 'Dyspnoea', 'Electrocardiogram normal', 'Fatigue', 'Flushing', 'Headache', 'Increased upper airway secretion', 'Influenza like illness', 'Myalgia', 'Pyrexia', 'Vaccine positive rechallenge']",2,MODERNA,SYR 1078929,,62.0,F,Minor chills 36 hours after shot with sever chills 6-8 pm evening of shot. Fatigue and joint aches 36 hours after shot. Slept much more then normal 12-36 hours after shot.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,UNK,Restasis,None,None,,None,"['Arthralgia', 'Chills', 'Fatigue', 'Somnolence']",1,JANSSEN,IM 1078932,CA,55.0,F,"Severe chills x 6 hours, fever (up to 102.5)x 18 hours, headache x 24 hours, body aches x 30 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PHM,None,None,None,,"Sulfa, bee stings","['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,JANSSEN,SYR 1078968,,32.0,F,"Severe chills, severe muscle aches, nausea, and headache. Began around 12:15 am. Severe chills got better with Tylenol after 8 hours. Then fluctuated between hot and cold. Nausea/ vomiting comes and goes. The muscle aches got better, then came back.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,UNK,Vitamin D,None,None,,None,"['Chills', 'Feeling cold', 'Feeling hot', 'Headache', 'Myalgia', 'Nausea', 'Vomiting']",1,JANSSEN,IM 1078970,NV,35.0,F,"headache, body/muscle aches, chills around 1130pm, about 12 hours after the shot. there was some arm pain about an hour after the injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/06/2021,0.0,PVT,,,,,PCN,"['Chills', 'Headache', 'Myalgia', 'Pain', 'Pain in extremity']",1,JANSSEN,IM 1078979,IL,38.0,F,"Severe muscle and joint pain, cold chills, extreme fatigue, headache, weakness dizziness. Started one hour after injection. Has not yet resolved, 2 days after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,WRK,"Effexor, Wellbutrin, Lamictal",None,Depression,,None,"['Arthralgia', 'Asthenia', 'Chills', 'Dizziness', 'Fatigue', 'Feeling cold', 'Headache', 'Myalgia']",1,JANSSEN,SYR 1078983,,35.0,F,"Pounding headache about 10-11 hours after vaccine administration. Took 1000mg Tylenol Extra Strength which did not help. Chills about 12-13 hours after vaccine administration, lasting several hours. High fever (102.8) about 17 hours after vaccine administration (took additional 1000mg Tylenol at 2am) and fever was gone by 8am. Muscle/shoulder extreme tightness on right side (same arm receiving vaccine). Dizzy & light-headed 24 hours after vaccine administration (almost passed out). Headache remains 12+ hours since it began despite the multiple doses of Tylenol described.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/06/2021,0.0,UNK,Insulin (humalog & trisiba),None,Type 1 diabetes,,None,"['Chills', 'Dizziness', 'Headache', 'Muscle tightness', 'Pyrexia']",1,JANSSEN,SYR 1078989,NH,28.0,F,"I had my vaccine at 12:15 pm. Five hours after vaccine, at 5 pm, I started to get chills. I took Advil and they went away. Once Advil wore off 5 hours later at 10 pm , I had a fever, very thirsty, shivers, and small headache. I took two more Advil at 11 pm and my shivers disappeared by midnight. By morning time my fever broke and I?m left with a small headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,UNK,Synthroid 88 MCG,,Acute asthma,,,"['Chills', 'Headache', 'Pyrexia', 'Thirst']",1,JANSSEN,SYR 1078991,NY,52.0,F,After receiving the shot about 30 seconds later I felt a gush of warm heat overcoming my body.With in a minute my throat got scratching and had a hard time Swallowing. My Tongue Swelled and my lips felt Numb.A Medic doc was called over to me. I was immediately taken to a tent with other Doctors. The doctor immediately gave me a Epipen in my right upper thigh. With in a few minutes EMS was there they tried to put a IV IN me but was unsuccessful. The EMT gave me a shot of Benadryl in my right arm. EMT rushed me to Emergency room. At the ER they put an IV in and gave me Dexamethasone and Pepcid. I was closely watched and was released after around 5 hours.,Not Reported,,Yes,Not Reported,,Not Reported,Y,03/02/2021,03/02/2021,0.0,OTH,"Seroquel, crestor, Ambein, Metoprolo,Prazosin, Xanx, Oxycodone D3",,Type 2 Diabetes,,Reglan Phegean Compazine Cat scan Dye,"['Dysphagia', 'Electrocardiogram', 'Feeling hot', 'Hypoaesthesia oral', 'Immediate post-injection reaction', 'Swollen tongue', 'Throat irritation']",1,PFIZER\BIONTECH,IM 1079005,MD,56.0,F,Fever of 100.3 and severe chills at 8pm on the same day I had the shot. Took 3 Advil (200mg/each) and was feeling a little better by 10pm. Woke up at 7am feeling fine but with a slight headache.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,None,None,None,Had a fever after the first flu shot I took in 9/19/2017; FluarixQuad 2017-18,None,"['Body temperature increased', 'Chills', 'Pyrexia']",1,JANSSEN,IM 1079025,CT,27.0,M,-Muscles Spasms (lasted about 15 minutes) -Fever -Chills (including chattering teeth) -Diarrhea -Vomiting -Sore Throat -Headache -Fatigue -Stomachache -Loss of appetite -Shortness of breath,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,SCH,,,,,,"['Abdominal pain upper', 'Chills', 'Decreased appetite', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Headache', 'Muscle spasms', 'Oropharyngeal pain', 'Pyrexia', 'Vomiting']",1,JANSSEN,SYR 1079028,LA,51.0,F,"Swelling of face; tightness in chest and shortness of breath and difficulty talking (with the exception of the swelling of the face, these are typical of my reactive airway) Treatment: Benedryl, albuteral, Outcome: Swelling has gone down, breathing is somewhat better",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,"Metformin, Synthroid, Singulair, albuterol, buspar, sumatriptan, topamax, Venlafaxine, Bystolic, Xanax",,"Reactive Airway Disease, anxiety",,"Oxycodone, penicillin","['Chest discomfort', 'Dyspnoea', 'Lack of spontaneous speech', 'Swelling face']",1,JANSSEN,SYR 1079031,IN,63.0,F,Itching and soreness at injection site 03/07/2021 Arthritis pain worse than usual 03/07/2021 Nausea 03/07/2021 Fatigue 03/07/2021,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/05/2021,03/06/2021,1.0,OTH,"Losartan, Imdur, Crestor, amlodopine, Effexor, Trazadone, carvidilol, methaninine, metformin, oxybutinin, low-dose aspirin, multivitamin levothyroxine.",Sinus issues,Hypertension Arthritis Asthma Seasonal allergies Depression,,Penicillin Lisinopril,"['Arthritis', 'Fatigue', 'Injection site pain', 'Injection site pruritus', 'Nausea']",UNK,JANSSEN,SYR 1079044,LA,41.0,F,"3/6/2021 9:30 pm - nausea 10:00 pm - chills and muscle spasms in stomach and legs and headache 10:30 pm - body aches and 99.2 fever and headache 3/7/2021 5:30 am - 100.1 fever and intense muscle soreness in neck, shoulders, arms, and lower back and headache 8:30 am - 98.9 fever and intense headache 10:30 am - intense headache and muscle soreness near injection sit",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,"LoLoestrin, Losartan HCL, Lexapro",None,None,,None,"['Chills', 'Headache', 'Injection site pain', 'Muscle spasms', 'Myalgia', 'Nausea', 'Pain', 'Pyrexia']",UNK,JANSSEN,IM 1079045,MA,83.0,F,"Initially, a UTI developed. As the UTI resolved, double pneumonia took hold. At the hospital they then discovered multiple clots in the legs.",Not Reported,,Yes,Yes,7.0,Not Reported,N,02/12/2021,02/15/2021,3.0,PUB,"Gabapentin, salt tablets, labetalol, Levothyroxine, Losartan, Tylenol PM",None,"scoliosis, discoid lupus, hypertension, neuropathy",,None,"['Deep vein thrombosis', 'Pneumonia', 'Urinary tract infection']",1,PFIZER\BIONTECH,SYR 1079052,MN,68.0,M,"Chills,fever,aches.fatigue Rest in bed, tylonol Still achy on second day, very tired",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,PUB,Sim a statin Allopuronil Omprozol,None,None,,None,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1079067,IN,71.0,F,Pain all over. Can hardly walk. Diagnosed with diverticulitis.,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/21/2021,02/02/2021,12.0,OTH,None,none,none,,none,"['Blood test', 'Computerised tomogram', 'Diverticulitis', 'Gait disturbance', 'Pain', 'X-ray']",1,PFIZER\BIONTECH,IM 1079076,MD,65.0,M,Vertigo or dizziness. Symptoms are mild. They became evident 30 hours after inoculation. I will remain home for the day and see how I feel tomorrow.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/07/2021,2.0,OTH,Vyvanse 70 mg Cap Oxcarbazepine 300 mg Tab Finasteride 5 mg Tab ? � of a tablet taken daily Atorvastatin 40 mg Tab Famotidine 40 mg Tab Metoprolol Tartrate 25 mg Tab Losartan-hydrochlorothiazide 50-12.5 mg Tab Omeprazole 20 mg Cpdr sr cap B,,"? Hypertension (High Blood Pressure) o Added 8/21/2015 ? Hyperlipidemia (High Blood Fats) o Added 8/21/2015 ? ADHD o Added 2012 ? Bipolar Disorder o Added 2012 ? Edema (Swelling) Leg ? Added 8/21/2015 ? ATHEROSCLEROSIS OF AORTA o Added 11/15/2016 ? OBESITY, BMI 30-34.9, ADU",,Lisinopril,"['Dizziness', 'Vertigo']",1,JANSSEN,IM 1079079,FL,34.0,F,Shingles. Woke up with facial pain and slight redness. This progressed into very painful full blown right sided facial shingles. In addition my 6months old baby contracted the chickenpox from my shingles.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/01/2021,02/10/2021,9.0,PVT,Erin tablet birth control,,Na,,,"['Erythema', 'Facial pain', 'Herpes zoster']",2,MODERNA,SYR 1079080,VA,28.0,M,"fever, chills, muscles weakness, running nose",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/06/2021,0.0,OTH,no,no,no,,no,"['Chills', 'Muscular weakness', 'Pyrexia', 'Rhinorrhoea']",1,JANSSEN,SYR 1079081,PA,34.0,F,"Immediate post vaccine: injection site soreness (mild), still present at time of event reporting (42hrs post vaccine) Approx 6hrs post vaccine: uncontrollable, full-body muscle tremors and chills. Came in waves lasting 15-45 seconds each, with rest periods of 30 seconds-2min. Overall, this event lasted approximately 1 hour. 9hrs post vaccine: patient was awoken around 3am with an increased resting heart rate of 100 bpm. Patient's normal resting heart rate is approx 76. Increased heart rate persisted until 18hrs post vaccine, at which point heart rate began to gradually return to normal. Normal resting heart rate returned about 26hrs post vaccine 9hrs post vaccine: acute joint discomfort, primarily in hips. Resolved around 17hrs post vaccine after patient took ibuprofen Unknown start time: Fever of 101.4. Patient took temperature 16hrs post vaccine and took ibuprofen at this time. Body temp went down gradually, returning to normal approx 20hrs post vaccine 16hrs post vaccine: general fatigue. Unknown if reason is solely vaccine or combination of vaccine and lack of sleep due to adverse events. Continued until patient slept from 28-40hrs post vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PHM,"Tri-Femynor, daily birth control",,,,Dexamethosone,"['Chills', 'Fatigue', 'Heart rate increased', 'Injection site pain', 'Insomnia', 'Musculoskeletal discomfort', 'Pyrexia', 'Tremor']",UNK,JANSSEN,IM 1079093,NE,37.0,F,Janssen-Covid19 vaccine eau Full body aches Extremely lethargic hard to grasp things with hands Dizzy when standing Severe headache/migraine Fever Cold Runny nose Congestion,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,SCH,,No,No,,Prednisone,"['Dizziness', 'Grip strength decreased', 'Headache', 'Lethargy', 'Migraine', 'Nasopharyngitis', 'Pain', 'Pyrexia', 'Respiratory tract congestion', 'Rhinorrhoea']",1,JANSSEN,SYR 1079104,VA,24.0,F,"Janssen COVID-19 Vaccine EUA Headache (mild) starting at 1:45 pm 3/6/21, became moderate at 7:00 pm, lasting until ~11:30 pm Chills (severe) starting around 7:00 pm, lasting until 10 pm Palpitations starting around 9 pm, lasting until 11:45 pm Mild injection site pain starting 1:30 pm, still occuring (12:15 pm on 3/7/21)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,OTH,"Duloxetine, Culturelle Women's Probiotic, Multivitamin",None,Chronic pelvic pain,,None,"['Chills', 'Headache', 'Injection site pain', 'Palpitations']",1,JANSSEN,IM 1079114,OH,39.0,F,"Around 10:30pm day of injection it started with severe body aches, including arms, hips, calf muscles. Then chills and dizziness. This occurred all night, waking at 7:45am with a 101.2 fever. This continued during the day after injection. Waking on 3/6 with sores in throat and on the roof of my mouth. This is the one thing that I have not see as a symptom of the COVID vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/06/2021,2.0,PUB,Nothing,None,"I am Diabete (Type 1), Vitiligo, Psoriasis",,"Penicillin, Sulfa, Morphine","['Chills', 'Dizziness', 'Pain', 'Pyrexia', 'Stomatitis', 'Throat lesion']",1,JANSSEN,IM 1079116,OH,62.0,F,"I couldn't sleep, I was very tired but I couldn't sleep. My head was throbbing , felt like it would burst. My blood pressure went up to 170/93. Ached all over rest of body.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,PVT,"Bupropion ER 100mg @ 1 a day, Quinapril 40mg @ 1 a day, Rosuvastatin 10mg @ 1 a day, Duloxetine 60mg @1 a day, Euthyrox 137mcg @ 1 a day",None,"High blood pressure, hypothyroidism, kidney disease stage 3",,adhesive,"['Blood pressure increased', 'Fatigue', 'Headache', 'Insomnia', 'Pain']",1,JANSSEN,SYR 1079120,NJ,72.0,F,Got pneumonia both lungs couldn?t breathe was hospitalized six days. Not around many people after injection and always wore a mask.,Not Reported,,Yes,Yes,6.0,Not Reported,Y,01/29/2021,02/06/2021,8.0,PUB,Heart meds. Asthma meds blood pressure meds Cholesterol meds,Open heart mitral valve repair Nov 2020,Asthma. Hay fever. Gerd. Hypertension. High cholesterol Arthritis. Diabetes,,Penicillin. Cows milk. Gluten,"['Blood test', 'Chest X-ray', 'Computerised tomogram', 'Dyspnoea', 'Pneumonia']",1,MODERNA,SYR 1079127,IN,57.0,F,"Adverse reaction came on rather suddenly around 6 PM, eight hours after injection and progressed rapidly lasting almost 48 hrs. Started with mild bodyaches that within an our became moderate, followed by moderate chills, mild headache that came and went over the 48 hours, moderate fatigue, and extremely sore at injection site but no visible redness or bruising. I did have a fever with the onset of the other symptoms. It started at 99.8 and then over the next 48 hours would fluctuate as high as 100.9 but never dropping below 99.8.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,UNK,Synthroid 88mcg CoQ10,,Hypothyroidism,,Great Sensitivity to prednisone,"['Adverse reaction', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1079129,IL,57.0,F,"Person received the Covid vaccine at 9:50 am and within 1 minute after the injections, patient appeared confused and was shanking, had a 2 convulsions while sitting in the chair that lasted 1 second each. Patient stated "" I don't know where I am"". Patient lowered to the ground, face mask removed. Patient systolic blood pressure was 110 during the episode with HR 56, pulse O2 98% room air. After approximately 4-5 minutes patients stated ""I'm feeling ok now"" is alert and oriented to self, place and time. Dr. assisted the patient, orange juice given to the patient. At 10:30am patient back to her baseline, no distress noted and discharged home, no distress at the discharge time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,WRK,Celexa,Hx of vasovagal response to injections and blood draws.,,,NKDA,"['Confusional state', 'Seizure', 'Tremor']",1,JANSSEN,IM 1079131,FL,47.0,F,I had a 101 fever by 3:00 p.m. that would not go down with fever reducing meds. I had aching joints and lethargy. I had chills and headache. My fever broke around 8:00 p.m. and as of this morning I'm better. It's totally worth it but I was told to report if we have any side effects so that data can be collected,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,Mimvey Lo (estrogen replacement) Omeprazole (reflux med),None,None,"Flu vax, body aches for one day. Jan 2021",Codeine,"['Arthralgia', 'Chills', 'Headache', 'Lethargy', 'Pyrexia']",1,JANSSEN,SYR 1079137,TX,84.0,F,"Weakness, several falls",Not Reported,,Not Reported,Yes,,Not Reported,U,01/26/2021,01/27/2021,1.0,SEN,,,,,,"['Asthenia', 'Fall']",2,MODERNA,IM 1079139,VA,43.0,M,"Fever of 104, heart rate in 160's, rigor, severe back pain. 911 called and ambulance brought to Hospital at 1am. Took 3 bags of fluids, Ativan, Tylenol and Toradol to get the heart to the 110's over the 3 hours there. It is now 12:30 on the following day (3/7) and the fever, shakes, and elevated heart is starting up again but not to the extreme of last night",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/06/2021,0.0,OTH,"Palenziq, Forteo, Protonix, Vitamin D, B complex",None,"PKU, severe osteoporosis, GERD, mild hernia",Flu shot in 2014 where it ended up acting as if he had the full round of the flu,None,"['Back pain', 'Blood lactic acid increased', 'Chills', 'Dehydration', 'Heart rate increased', 'Pyrexia', 'Tremor']",1,JANSSEN,SYR 1079150,OH,60.0,M,"Headache, nausea, bodyaches, chills. Tylenol At least 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PVT,Lysyniprel 20 mg,None,High blood pressure,,Aspirin,"['Chills', 'Headache', 'Nausea', 'Pain']",1,JANSSEN,SYR 1079153,WA,50.0,F,Sudden unilateral hearing loss. Undergoing treatment with prednisone at this time.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/02/2021,03/03/2021,29.0,PVT,"Wellbutrin, Lamictal, Losartan",none,hypertension,,none,"['Acoustic stimulation tests', 'Deafness unilateral', 'Sudden hearing loss']",2,MODERNA,IM 1079164,VA,42.0,F,"Started with feeling tired around 6pm, woke up at 3:30 am (ish) to wanting to vomit, shivering, high fever over 103, aweful headache, dizzy, breathing feels labored. Now at 12:30 pm, arm is extremely sore at site, chest still feels funny when taking deep breaths, head still aches but not as bad, not quite as tired.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,Maxalt XLT Migraine medication Ajovy injection takeing 3 weeks before vaccine given Breo,none.,Asthma Reynauds,,onions erthurmysn pencillin pollin (all trees and grasses) Animal dander (All animals),"['Chest discomfort', 'Chills', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Headache', 'Injection site pain', 'Pyrexia', 'Vomiting']",1,JANSSEN,IM 1079165,OH,70.0,M,"Severe pain in wrist, minor swelling in wrist join",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/07/2021,2.0,OTH,"oxycodone, enalipril, glipizide, tacrolimus, vitamin d, mycophenolate, warfarin",,"Neuropathy, liver transplant recipient",,,"['Arthralgia', 'Joint swelling']",1,JANSSEN,SYR 1079169,CA,35.0,F,Body aches and nausea started at 9 pm 9:30 am started vomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,PHM,Sodium Chloride Adderall Zoloft,,POTS (postural orthoststic tachachardia syndrome),,Na,"['Nausea', 'Pain', 'Vomiting']",1,JANSSEN,SYR 1079175,CT,44.0,F,Vaccine administered 10:15am. Got a headache and mild nausea 12:15pm (2 hours later). 5:15pm (7 hours later) started to shake violently. Couldn't walk was shaking so much. Speaking was difficult. Breath was labored. It was so scary my husband called the doctor. Shook violently with teeth chattering for 45 minutes then would break for a few minutes before shaking again. The shaking was probably 60 minutes total. Then fever set in. Fever hit 102.4 at 6:15pm. 102.9 at 6:40pm. 103.8 at 8:15pm. Fever ranged between 102.3 and 103.8 for 8 hours after starting then finally broke 1:45am (8 1/2 hours after the shaking started). Was able to get out of bed 8:00am today. Massive headache for the morning but no fever today. 26 1/2 hours post vaccine new and I just feel very tired and drained.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/06/2021,0.0,PVT,Tirosint 125mcg once a day Spironolactone 100mg once a day Methylphendia ER 54mg once a day,None,Ventricular septal defect Hypothyroidism,,None,"['Chills', 'Dyspnoea', 'Fatigue', 'Gait disturbance', 'Headache', 'Lack of spontaneous speech', 'Nausea', 'Pyrexia', 'Tremor']",1,JANSSEN,IM 1079176,DC,25.0,M,Woke up at 1:30 am with shivers and vomited. Felt dehydrated. Woke up one hour later sweating and vomited. Repeat back and forth cycle until 7am. Feeling much better now. Just achy.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,None,"Bicycle accident. Flipped over a chunk of cement on the roadway. Scratches to face, minor concussion, sprained right wrist and bruised left knee. Date of incident 03/03/21",None,,None,"['Chills', 'Hyperhidrosis', 'Pain', 'Thirst', 'Vomiting']",1,JANSSEN,SYR 1079178,WA,78.0,M,AFIB diagnosis,Not Reported,,Not Reported,Yes,1.0,Yes,N,01/20/2021,01/26/2021,6.0,PVT,Mirapex .25Mg Atorvastatin 40mg Melatonin 10mg Multivitamin,none,,,none,"['Atrial fibrillation', 'Blood test', 'Electrocardiogram']",2,PFIZER\BIONTECH,IM 1079181,IL,38.0,M,"I fainted the following evening after my vaccination. I felt fine all day and after dinner started to feel flush, vision became blurry and had trouble hearing. Within 3 minutes I fainted. Felt fine after coming to, and have felt fine so far the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/06/2021,1.0,OTH,Omeprazole Finestride Vitamin D3 Men's Multi-Purpose Vitamin,,,,,"['Flushing', 'Hypoacusis', 'Syncope', 'Vision blurred']",1,JANSSEN,SYR 1079203,VA,28.0,M,"Headache,muscle ache,fatigue, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/06/2021,0.0,OTH,None,None,No,,No,"['Chills', 'Fatigue', 'Headache', 'Myalgia']",1,JANSSEN,SYR 1079204,MD,39.0,F,"Body aches, chills, 101 fever overnight. Treated with Tylenol. The next day a lump appeared under the vaccinated arm (in the armpit), which is tender. Vaccine site is very sore when arm is moved. Now it?s day 3 and the vaccine site is still sore and the lump in armpit is still there.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,OTH,"Flo gummy vitamins, biotin vitamin",None,None,,None,"['Axillary mass', 'Axillary pain', 'Chills', 'Pain', 'Pyrexia', 'Vaccination site pain']",1,JANSSEN, 1079211,VA,34.0,F,102 degree fever Chills Headache Took three doses of Tylenol over 16 hrs; symptoms subsided with Tylenol and time,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,Pre-natal vitamins,None; delivered baby 2/23/2021,None,,None,"['Chills', 'Headache', 'Pyrexia']",UNK,JANSSEN, 1079216,FL,48.0,F,"Patient experienced uncomfortable feeling in back of throat, bumps in back of throat, coughing, and shortness of breath consistent with anaphylactic reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PHM,,,,,food and environmental,"['Cough', 'Dyspnoea', 'Oropharyngeal discomfort', 'Throat irritation']",1,JANSSEN,IM 1079217,DC,33.0,F,"Janssen COVID-19 - grade 3 fever-- 102.1 maintaining with tylenol and ibuprofen - chills - aches/sore joints - headache - fatigue - nausea (dry heaving, can't eat)",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/07/2021,1.0,UNK,ivf fertility injections and asthma medication (daily inhaler),,"asthma, endometriosis, early menopause",,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Hypophagia', 'Nausea', 'Pain', 'Pyrexia', 'Retching']",1,JANSSEN,IM 1079220,NM,41.0,F,"Facial numbness on right side Extremely sore joints in the neck, arms, hands, legs, feet Headache Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PUB,Aspirin 81mg,None,Clotting disorders,,None,"['Arthralgia', 'Headache', 'Hypoaesthesia', 'Pyrexia']",1,JANSSEN,SYR 1079228,IL,56.0,F,"I got severe chills where after a warm shower put on pajamas pants and a long sleeved top, got under my cotton blanket, level 4 down blanket, and heating pad on high and I was still shivering. my daughter brought me socks and i put on a cashmere sweater. my other daughter brought me two fleece blankets. Also, I had a severe headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,WRK,Flonase,none,none,,Penicillin,"['Chills', 'Headache']",UNK,JANSSEN,SYR 1079238,NY,69.0,F,"nuseau, dizziness, red blotch on right side of face",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/05/2021,03/05/2021,0.0,UNK,"atenolol, zanax, oxycodone",,"lung cancer , breast cancer, in remission",,flagell,"['Dizziness', 'Erythema', 'Nausea', 'Rash macular']",UNK,JANSSEN, 1079239,NJ,39.0,F,"pain in the injection site, fever 103 (started at about 3 PM 03/06/2021 from 99F, then increased to 100, 102, 103 by midnight, decreased to 99 at 2 AM on 03/7/2021), chills, headache, weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PHM,"Synthroid, Cymbalta, Cytomel, multivitamins",none,"Hypothyroid, cmp, depression, anxiety DDD, CP",,"shrimps, sulfo","['Asthenia', 'Chills', 'Headache', 'Injection site pain', 'Pyrexia']",1,JANSSEN,IM 1079247,NY,56.0,F,"I started to experience symptoms around noon time on the day of vaccination. It started with a low-grade fever. Slowly over the course of the day, I started to experience body aches, chills and headaches. My left arm where I received the vaccine felt strange. My fever got up to 100.4. During the night I had chills. It felt like my fever broke early in the morning. I woke up okay and I feel like I could go about my day with no problem. I no longer have a fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,None,None,I had a splenectomy because of my autoimmune condition ITP. Since my spleen was removed in 1998. my ITP is in remission.,,None,"['Chills', 'Feeling abnormal', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1079251,WA,68.0,F,Patient died the day after she received her vaccine,Yes,03/06/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,OTH,Patient died the day after vaccination on 03/06/2021,Unknown,Unknown,,Not recorded,['Death'],UNK,MODERNA,IM 1079279,NJ,72.0,M,Diarrhea started 10:30am 3/7/21 Chills began 12 noon 3/7/21 Took Extra-Strength Tylenol 2 x 500mg at 12:30pm 3/7/21,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,PHM,Edari 80mg Atorvastatin 20mg Omega-1 Chlorthalidone 25mg Clonidine 0.1mg Centrum Silver 500 mg Vitamin C 500 mg D3 5000 IU Glucosamine 1500 mg Turmeric 500mg Tart Cherry 1000mg,gout,high blood pressure gout,,no,"['Chills', 'Diarrhoea']",1,JANSSEN,SYR 1079305,NY,25.0,F,Fever 102 degrees 12 hrs after injection lasting 8 or so hrs. 34 hrs later dizziness and fainting lasting a short while.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,UNK,None,None,None,,Penicillin Sulfates,"['Dizziness', 'Pyrexia', 'Syncope']",1,JANSSEN,SYR 1079309,ME,72.0,F,"Patient reports bad chills, shaking, headache, but no fever starting 7 hours post administration of COVID-19 vaccine. Symptoms resolved within 36 hours. Patient had new onset of nausea/diarrhea 48 hours post administration. Patient advised to hydrate and monitor GI symptoms, and call provider if symptoms last more than 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,PUB,none,none,"Hypertension, Barrett's Disease with hiatal hernia",,extensive list of medication allergies,"['Chills', 'Diarrhoea', 'Headache', 'Nausea', 'Tremor']",1,JANSSEN,IM 1079319,NJ,51.0,M,"Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Loss of feeling on finger for 30 minutes-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,,,,,,"['Asthenia', 'Chest discomfort', 'Dyspnoea', 'Headache', 'Nausea', 'Sensory loss']",1,JANSSEN,IM 1079340,,32.0,F,"High fever (>103 F), body aches, chills, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,PHM,Loestrin 24 FE,,Asthma,,,"['Chills', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1079343,MN,88.0,M,"Patient started feeling weak/fatigue on 3/4 and progressive get worse. He became very weak, had unsteady gait and s/p fall which resulted scalp laceration. He came to the emergency at noon on 3/5 and was sent home. He had another fall and came back to ER in evening. He had another fall while in the ED. He continues to have generalized weakness and myalgia. He was seen by PT and recommended to d/c with his walker",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,03/03/2021,03/05/2021,2.0,PVT,None,None.,DM COPD Atrial fib HTN HL,,Aspirin,"['Asthenia', 'Computerised tomogram head', 'Computerised tomogram spine', 'Fall', 'Fatigue', 'Full blood count', 'Gait disturbance', 'Magnetic resonance imaging head', 'Metabolic function test', 'Myalgia', 'Skin laceration', 'Walking aid user']",2,MODERNA,IM 1079349,NH,71.0,F,"headache, body aches, chills -- starting around 4 a.m. and gone by 11:00 a.m. same day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,"Atorvastatin, Albuterol, Diltiazem, Duloxetine, Fluticason, Lantus Glargine, Losartan, Novolog, Pioglitazone, Trazodone, Xarelto, Centrym Silver, Cetirizine Hydrochloride, Omeprazole, Probiotic, Vitamin D3, calcium",,"Diabetes, high blood pressure, high cholesterol, factor V leiden blood clotting disorder",,,"['Chills', 'Headache', 'Pain']",UNK,JANSSEN, 1079351,PA,54.0,F,"headache, stiff muscles and joints, chills, high fever, nausea, exhaustion",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,"levothyroxine .88 x 1, symbicort 80/4.5 2 puffs x 2, vicodin prn",,"asthma, copd, chronic back pain",,vycral sutures,"['Chills', 'Fatigue', 'Headache', 'Joint stiffness', 'Musculoskeletal stiffness', 'Nausea', 'Pyrexia']",1,JANSSEN,IM 1079353,IL,55.0,M,"Mild to moderate body aches begin approximately 6 hours after injection. At around 12 hours chills, headache, and body aches severe in nature with fever of 100.8. Bed ridden from the 12 hour mark until 27 hour mark. Symptoms gradually subside until gone the morning of 03/07/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PUB,"Met form in 2000 / day, glimepiride 2mg/day, Lipitor 20mg/day , low dose aspirin, centrum silver men,",,,,"Penicillin allergy- hives, rash Adhesive tape allergy- rash","['Bedridden', 'Chills', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1079371,NE,31.0,F,"Extreme fatigue starting around 2/3pm Upon waking from sleep around 7pm extreme chills and muscle aches had set in. Fever reached 102 around 10pm. Terrible sleep through the night, jittery and painful Woke to less severe chills, body aches and migraine. Lymph node tenderness. Fever of 100 Symptoms have not improved as of 1:30pm the next day following my injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,SCH,"Vitamin C supplement, biotin/keratin supplement, 24 hour allergy (loratadine), isobloom birth control",,Asthma,,Latex,"['Chills', 'Fatigue', 'Feeling jittery', 'Insomnia', 'Lymph node pain', 'Migraine', 'Myalgia', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1079374,NY,63.0,F,"Fever, nausea, extreme fatigue, body aches - non-stop since a little after midnight.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,UNK,"Lisinopril 20 mg, Hydrochlorothiazid 25 mg; Asprin 81 mg, Probiotic 10-20, Multivitamin, Vitamin D 2000IU, Magnesium 400",None,High blood pressure,,None,"['Fatigue', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1079380,OH,63.0,F,"I noticed aching in my legs and 3 hours later I woke up and it was worse. I also had chills and shaking, a slight headache, and mild nausea. This continued into the next day (March 7, 2021). It was significantly better by mid-afternoon.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,Escitalopram -20 mg QD Bupropion-100 mg QD Doxycycline-100 mg QD Pepcid (generic)-20 mg BID Baby aspirin QOD Multivitamin QD Zinc -25 mg- 3 times a week Restasis eye drops Reclast infusion every other year,None,Depression & OCD well-controlled with medicine GERD Osteoporosis/Osteopenia,,Bactrim caused a rash many years ago,"['Chills', 'Condition aggravated', 'Headache', 'Nausea', 'Pain in extremity', 'Tremor']",1,JANSSEN,IM 1079388,CT,63.0,M,Four hour after injection I started to shiver almost uncontrollably. My temperature around midnight spiked to 103 and my heart rate was constant at 150. I was dizzy. Very little sleep. Temperature broke at 4:00AM,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/06/2021,03/06/2021,59.0,OTH,Allopuranhol Crestor Niaccin Bayer Asprin,None,Gout,,None,"['Body temperature increased', 'Chills', 'Dizziness', 'Heart rate increased', 'Insomnia']",1,JANSSEN,SYR 1079396,MA,45.0,F,"Patient left observation room early even though patient was advised to sit for 30 minutes. When patient went out to her car she noted redness on her face. The patient came back in the clinic at which time she was noted to have red blothching throughout. Patient denied any respiratory distress at the time. Patient was hypertensive and transported EMS. Patient received IV solumedrol, IV benadryl, and is advised to NOT take second dose of COVID 19 vaccine.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/25/2021,02/25/2021,0.0,OTH,,,,,Patient reported medication allergy and allergy to crustaceans,"['Erythema', 'Hypertension', 'Rash macular']",1,MODERNA,IM 1079410,CO,62.0,F,"Janssen COVID-19 Vaccine EUA. Gradual headache late afternoon, followed by neck ache, then muscle aches, Horrible chills and shakes, nausea and throwing up. Muscle aches continued throughout the night and into the morning. Left with some muscle aches, stuffy head today. Tylenol did not help in the evening, so switched to Advil at midnight and that started to help.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,"VIT B, VIT C, VIT D",None,None,,"Lactose intolerant,","['Chills', 'Headache', 'Myalgia', 'Nausea', 'Neck pain', 'Sinus congestion', 'Tremor', 'Vomiting']",,JANSSEN,IM 1079411,MS,50.0,F,"Individual responded to waiting parking lot. Patient c/o sensation of facial swelling and heart racing. Denied other complaints. 1500 B/P 110/80. HR 140 Resp 12. 1503 Pt states she felt heart rate slowing down. No further feeling of swelling in face, throat, or elsewhere. 1505 HR 128. 1510 Patient talking and breathing without difficulty. Advised to seek medical attention if s/s worsen. 3/5/2021 @ 1040 employee f/u with patient with phone call. Patient reported that after leaving the site, she felt HR increasing. Went to ED and was monitored for two hours. Systolic pressure there was 161. HR was in 140s. No interventions by ED after monitor. States is fine today.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,OTH,Xysel 50 mg PO daily,,,,Sulfa,"['Palpitations', 'Swelling']",1,JANSSEN,IM 1079412,NC,59.0,F,Right side face swell hives down right arm and chest and neck Rapid pulse 180/89 bp shaking trembling Redness nauseous pain in rt arm,Not Reported,,Yes,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,SCH,Metformin,None,Diabetes type 2,,Penicillin motrin tigan sulpha aspirin suprax,"['Erythema', 'Heart rate increased', 'Nausea', 'Pain in extremity', 'Swelling face', 'Tremor', 'Urticaria']",1,MODERNA,SYR 1079414,IN,65.0,M,"severe left leg calf pain started on March 5, within 24 hours of recieving dose #2 of Moderna vaccine . Went to Hospital on Saturday evening with worsening pain. I have been admitted to the hospital.",Not Reported,,Yes,Yes,,Not Reported,N,03/04/2021,03/05/2021,1.0,PUB,,,,,,"['Pain in extremity', 'Ultrasound Doppler']",1,MODERNA,IM 1079425,NM,70.0,F,"I received the vaccine at a Department of Health vaccine clinic at the Hospital. About 25 minutes after receiving the Janssen vaccine, my face became flushed (red) and I felt weak. We were in the hospital parking lot and drove to that hospital's emergency room, where I was evaluated. After several tests (item 18) I was declared okay and left after 3 hours with no further intervention. I probably should have taken a Benadryl (diphenhydramine) after the shot to prevent such a reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,"losartan, amlodipine, montelukast, atorvastatin, paroxetine, AREDS vitamins, Advair HFA 230/21 inhaler for asthma",none,"Moderate asthma, fibromyalgia, primary hypertension, general anxiety disorder","penicillin (puncture wound), anaphylactic shock, age 2, 1952",Penicillin (anaphylactic shock at age 2) Oxaprozin (NSAID) -- face turned bright red - early 50s Sulfa drugs -- hives - mid-50s,"['Asthenia', 'Chest X-ray normal', 'Electrocardiogram normal', 'Flushing', 'Full blood count', 'Metabolic function test', 'Troponin I normal']",,JANSSEN,IM 1079466,NC,30.0,F,"Fever, chills, headache, body aches, tiredness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PUB,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",UNK,JANSSEN, 1079468,FL,69.0,F,Within 10 minutes I was very dizzy. The firemen took my blood pressure sitting was 172. They had me stand and it went to 122. Sitting again it went to 199. I was taken to the hospital. At the hospital I was made aware my heart rate was under 50. I was admitted.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/04/2021,03/04/2021,0.0,UNK,quinapril 40mg. blood pressure escitalopram (Lexapro) 10 mg simvastin 10mg cholesterol metformin 750md/day,,,,latex,"['Dizziness', 'Laboratory test']",1,MODERNA,SYR 1079471,PA,76.0,F,heart palpatation,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/05/2021,03/06/2021,1.0,OTH,ztampa13.5mg lyrica 50MG QD Tylenol 500mg BID olmsartab tizanadine,none known,pain HBP/palpataions arthritis,,NKA,['Palpitations'],1,JANSSEN,SYR 1079476,GA,42.0,F,The patient experienced a metallic taste shortly after vaccination. The patient then experienced a severe headache and nausea about 13 hours after vaccination .,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,PHM,"Ozempic ,levemir, lisnopril/hctz , humalog",No,"Diabetes , high blood pressure",,"Codeine , onions","['Dysgeusia', 'Headache', 'Nausea']",1,JANSSEN,IM 1079482,NY,102.0,F,"102 female who is a COVID survivor.. had a mild case of COVID in May 2020. Received first dose of Moderna at assisted living facility on approximately January 20th and suffered no ill effects. Had second Moderna vaccination late afternoon of February 8th. Later that evening or in the early morning of February 9th tried to go to the bathroom and either fainted or fell onto the bathroom floor on her face. Lay on the bathroom floor face down until assisted living facility staff found her in the morning when they were passing out medications. Taken to ER at hospital on 2/9/2021. Was not admitted to hospital- all CT scans and x-rays and blood work were normal. Taken back to assisted living facility where she exhibited dramatic change in behavior- uncooperative, refusing to eat or take meds, refusing to get OOB. Mentally a decline in cognition. Transferred to different facility with higher level of care on February 15th and is improving somewhat.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/08/2021,02/08/2021,0.0,SEN,Touresmide BID. Prostat TID,none,Atrial fibrillation- has pacemaker.,,none,"['Abnormal behaviour', 'Blood test normal', 'Cognitive disorder', 'Computerised tomogram normal', 'Face injury', 'Fall', 'Food refusal', 'Mobility decreased', 'Patient uncooperative', 'Syncope', 'X-ray normal']",UNK,MODERNA,IM 1079483,IN,74.0,M,Severe soreness at injection site area from day after until present. Sometimes very painful to move or lift right arm. Sometimes pain goes to right elbow as well.,Not Reported,,Not Reported,Not Reported,,Yes,N,01/28/2021,01/29/2021,1.0,PVT,ASA 81mg 1/day Bentyl 20mg 2/day Multivitamin 1/day Requip 1mg 2/day Terazosin 5mg 1/day Zomig 5mg as needed for migraine Hydrocodone-acetaminophen 10/325 as needed for back pain Glucosamine /Chondroitin 750/,none known,Degenerative disc and bone disease; Benign Prostatic Hypertrophy; Chronic Migraine; Restless leg Syndrome,,None known,"['Arthralgia', 'Injection site pain', 'Pain']",2,PFIZER\BIONTECH,IM 1079487,CT,32.0,F,"lightheaded, blackout, overheating, fever, chills, headache, stiff neck, muscle soreness, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2001,03/05/2001,0.0,SCH,Tri-Lo-Marzia and Sertraline,,,,,"['Chills', 'Dizziness', 'Fatigue', 'Feeling hot', 'Headache', 'Loss of consciousness', 'Musculoskeletal stiffness', 'Myalgia', 'Pyrexia']",1,JANSSEN,SYR 1079494,NJ,55.0,F,Feet and leg hands arms back. Pins and needles numb,Not Reported,,Not Reported,Yes,5.0,Not Reported,N,01/29/2021,02/04/2021,6.0,PUB,Atenelol Synthroid Nexium B-6 Clacium Multivitamin,None,High blood pressure,,,"['Hypoaesthesia', 'Paraesthesia']",UNK,PFIZER\BIONTECH, 1079495,GA,25.0,F,The patient experienced a metallic taste shortly after vaccination. The patient then experienced a severe headache and nausea about 13 hours after vaccination .,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,PHM,"Omeprazole , Wellbutrin",None,Hypoglycemia,,"Amoxil , Sulfa drugs , Vanilla Scent","['Dysgeusia', 'Headache', 'Nausea']",1,JANSSEN,IM 1079498,FL,73.0,M,"Partial right facial nerve paralysis ( Bell's Palsy ) At 2 PM, Sunday, looked in mirror, noticed drooping of right angle of mouth and flattening of naso labial fold. Seen MD , had MRI of brain which was normal. Was referred to and evaluated by physical therapist, prescribed daily exercises, massages .",Not Reported,,Not Reported,Not Reported,,Yes,N,02/03/2021,02/20/2021,17.0,PVT,"Tamsulosin 0.4mg daily, Dutasteride 0.5 mg every other day",None,BPH,,None,"[""Bell's palsy"", 'Facial paralysis', 'Magnetic resonance imaging head normal']",2,MODERNA,IM 1079500,IA,57.0,F,"itching, hives, redness, dizzy",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PUB,,,,,,"['Dizziness', 'Erythema', 'Pruritus', 'Urticaria']",1,JANSSEN,IM 1079511,CO,,U,"Fifteen mins after receiving vaccine, I had a numb feeling in left jaw and lower teeth which spread to the arm and then hand. It was not severe, rather it felt like the after effects of having a dental numbing shot. About 20 minutes later I could feel it in my hip and left leg. The numbness subsided after about an hour. After that I felt a little tired with sore muscles everywhere. This is the same feeling as when the flu is coming on. That evening at approximately 9:00PM I became sick with high fever of 102 with uncontrollable shaking related to the fever . After a hot shower which calmed the shaking and 2 Motrin I was able to sleep and by morning the fever was broken. I felt hungover upon awakening with a headache. Two more Motrin and feeling much better, just tired after a long night. I had not expected these side effects and when I searched the expected side effects and didn't see these symptoms I thought I should report it. Prior to taking the vaccine, my husband and I were in deep quarantine for the birth of our granddaughter for 3 weeks. The first time out among other people was at the vaccine facility. It is highly unlikely that I could have been exposed to an illness before the vaccine. And, it was immediately upon receiving the vaccine that I began to feel symptoms. I am 100% positive my illness overnight was due to the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,OTH,,,,,,"['Fatigue', 'Headache', 'Hypoaesthesia', 'Malaise', 'Myalgia', 'Pyrexia', 'Tremor']",UNK,JANSSEN,SYR 1079512,OH,63.0,M,"Dull lingering headache lasted approximately 30 hours. fatigue; slept for over 12 hours. Severe body / joint pain that started in mid back and spread to rest of body. Worst pain was focused in lower back, hips, knees and ankles. Climbing stairs was difficult. Facility nurse said my face was flushed but I had no fever. Symptoms were 90% gone shortly after headache subsided. I did need to call off of work on 03/07/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,WRK,Vit D oil of oregano vit c multi vitamin milk weed thistle,,A-Fib,,,"['Arthralgia', 'Fatigue', 'Flushing', 'Headache', 'Hypersomnia', 'Loss of personal independence in daily activities', 'Pain']",1,JANSSEN,IM 1079516,NE,96.0,F,"There were no symptoms experienced on the first vaccination given on 1/14/2021. The second vaccination was given on 2/4/2021, the following day (2/5/2021) patient complained of fatigue and nauseau. In the evening she went into cardiac arrest and died.",Yes,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,SEN,,,Vular Squamous Cell Carcinoma Congestive Heart Failure Hemarthrosis,,Penacillin - rash,"['Cardiac arrest', 'Death', 'Fatigue', 'Nausea']",UNK,PFIZER\BIONTECH,UN 1079517,MI,42.0,F,After the first injection I had mild eye issues which I went to my PCP and they cleared up within a week. The symptoms were dry eyes which was uncomfortable. The second injection dry eye issue has been excruciating and still problematic to where I can?t even open my eyes. I am seeing my PCP and an ophthalmologist to treat this.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/23/2021,02/25/2021,2.0,PUB,Adderal XR 30 mg BID,None,None,,None,"['Dry eye', 'Eyelid function disorder']",1,MODERNA, 1079525,VA,54.0,F,I had an cold burning sensation on the top of my left fingers around 7:15pm. Around 7:50 I had uncontrollable chills that lasted throughout the night along with a fever of 102.7. On 3/6/2021 I was exhausted and had muscle soreness. I had no appetite and my food tasted funny. I could only work for half my shift. I slept most of the day . On 3/7/2021 I am still very tired and achy.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PHM,None,None,None,,Sulfa,"['Burning sensation', 'Chills', 'Decreased appetite', 'Dysgeusia', 'Fatigue', 'Feeling cold', 'Myalgia', 'Pain', 'Pyrexia', 'Somnolence']",1,JANSSEN,SYR 1079532,NY,49.0,M,"Fever (99.3), nausea, diarrhea, fatigue, body aches. Symptoms other than fever began around 12:30pm on 3/7/21. Fever began at 3:30 pm on 3/7/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,OTH,"Bisoprolol/HCTZ, turmeric, Conjugated Linoleic Acid, chromium picolinate, CO Q-10",None,Hypertension,,,"['Diarrhoea', 'Fatigue', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1079543,NM,19.0,F,"Approximately 36 hours after the second vaccine the patient began to experience palpitations, tachycardia, shortness of breath, dizziness and left arm/scapula pain.",Not Reported,,Not Reported,Yes,,Not Reported,N,03/04/2021,03/05/2021,1.0,PHM,Micronor 0.35mg daily Imitrex 25mg prn,"Currently being evaluated by PCP and neurology for possible MS, positive ANA with speckled pattern",None,,None,"['Arthralgia', 'C-reactive protein increased', 'Dizziness', 'Dyspnoea', 'Electrocardiogram T wave inversion', 'Pain in extremity', 'Palpitations', 'Tachycardia', 'Troponin I increased']",2,MODERNA,IM 1079544,LA,62.0,F,"pt. presented to the ED at hospital with SOB, that didn't resolve with inhaler, and generally not feeling well. ED note attributed to the COVID vaccine",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,03/02/2021,03/03/2021,1.0,PVT,,,"Hx of Asthma, CHF",,"ACE INHIBITORS; CEFTRIAXONE; FISH CONTAINING PRODUCTS; GABAPENTIN; KETOROLAC; LATEX, NATURAL RUBBER; MORPHINE; OMEGA-3 ACID ETHYL ESTERS; PINEAPPLE; SHELLFISH CONTAINING PRODUCTS; VERAPAMIL","['Dyspnoea', 'Malaise']",1,PFIZER\BIONTECH,IM 1079579,NY,52.0,F,"1:30pm Slight Headache started and slowly got worse 2:30pm Muscle Aches started. Especially in my lower back. 3:00pmTook temperature-100 There is no swelling on my arm, just a little achey Took 2 xtra strength Acetaminophen @3:30pm 500 mg each It is now 4:30 and I still feel symptoms but they are not as bad.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,OTH,"Synthroid .50, paroxetene mesylate 7.5, ezetimibe 10mg, biotin 10,000, Vitamin D 4000iu",None,"Hypo Thyroid, Hyper Parathyroid, Hot Flashes",,Biaxin,"['Condition aggravated', 'Headache', 'Myalgia']",1,JANSSEN,SYR 1079595,NY,20.0,F,- severe body aches - high fever (102.6 peak before taking Tylenol) - headaches - tingly sensation in skin - muscle soreness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PUB,Sertraline,,,,,"['Headache', 'Myalgia', 'Pain', 'Paraesthesia', 'Pyrexia']",1,JANSSEN,IM 1079605,MA,50.0,F,"Within 5 minutes felt dizzy, got very hot, face went pale, and had a fast heart beat",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PHM,Levo thyroxine Astelin nasal spray Loratidine,None,Hypothyroid Seasonal allergies,Flu vaccine,Penacillin Sulfa drugs Benzalclonium chloride,"['Dizziness', 'Feeling hot', 'Heart rate increased', 'Pallor']",1,JANSSEN,IM 1079606,NE,32.0,F,"Foggy/dizzy almost immediately following vaccination, sever chills that lasted for hours overnight, fever of 102.1 (brought down with Tylenol, it remained at or a over 100 for 8 more hours), nausea, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,WRK,"Culturelle, miralax, Zyrtec, multivitamin",Minor cold,N-a,,None,"['Chills', 'Dizziness', 'Feeling abnormal', 'Headache', 'Nausea', 'Pyrexia']",1,JANSSEN, 1079614,MN,67.0,F,All symptoms started about 7 hours after injection: Severe chills and shaking (lasted approximately 3 hrs) Bad headache (lasted 24 hrs) Exhaustion (lasted 24 hrs) All adverse symptoms gone after 36 Hours from injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,UNK,Using none,None,None,"Shingix, 65 yo. Exhaustion and severe headache",Penicillin,"['Chills', 'Fatigue', 'Headache', 'Tremor']",1,JANSSEN,SYR 1079621,,,U,"Appx 8 hours after injection site became so painful bi could not use my arm and my finger tips are tinglin, BOTH EVENTS ARE STILL OCCURRING. I have this issue but normally only in the morning. . Today my stomach began having hard cramps when I woke. In general I feel like I have the old fashioned file weak, tired and s headache residing in the front of my head.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Abdominal pain upper', 'Asthenia', 'Fatigue', 'Headache', 'Injected limb mobility decreased', 'Injection site pain', 'Paraesthesia']",1,JANSSEN,IM 1079627,OH,80.0,F,"DEVELOPED SWOLLEN THROAT GLANDS, SORE THROAT, SWOLLEN FACE, KNOT UNDER CHIN, PAIN AROUND NECK",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/05/2021,1.0,PHM,,,,,,"['Neck pain', 'Oropharyngeal pain', 'Pharyngeal swelling', 'Skin mass', 'Swelling face']",1,JANSSEN,IM 1079633,MD,70.0,F,"7:30pm unusual restlessness in both legs; by 8:30pm dull constant pain increased, legs were weak, knees wobbly, hands shaking. Pain in legs became intense; I could not sit on the toilet. Went to emergency room of Hospital at 9pm; no medications given. Pain calmed by 10pm, but sensation in legs returned at 11pm and continued until discharge at 1:15am on 3/6. Took Tylenol PM at home for moderate pain in legs and went to bed. Awakened next morning to no pain, had breakfast and went back to bed until noon. Feeling fine since that time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,"Atorvastatin, Famotidine, Montelukast Aspirin, Caltrate D, D3, Multivitamin, Systane eye drops, Vitamin C",None,None,,"Codeine, Sulfa","['Laboratory test', 'Muscular weakness', 'Pain', 'Restless legs syndrome', 'Tremor', 'Urine analysis']",1,JANSSEN,IM 1079634,,,U,"Pain and burning when given the vaccine, pain and swelling from the shoulder to my elbow, diarrhea, chills, headache, very tired, nausea, muscle aches, fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Nausea', 'Pyrexia']",1,JANSSEN,SYR 1079638,NY,65.0,M,"chills, 101.5 fever 24 hr.s, soreness at injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PHM,,emphezema,,,,"['Chills', 'Injection site pain', 'Pyrexia']",1,JANSSEN,IM 1079643,MN,56.0,M,Admitted w/ COVID-19 PNA on 03/03/21 on HFNC 50L. Now w/ superimposed HAP.,Not Reported,,Yes,Yes,5.0,Not Reported,N,02/03/2021,02/27/2021,24.0,PVT,"ASA (81 mg QD), Lipitor 20 mg QD, Folic Acid 1 mg QD, Lisinopril-HCTZ 10-12.5 mg QD, Multivitamin,",CLL.,CLL,,None.,"['COVID-19 pneumonia', 'Chest X-ray abnormal', 'Leukocytosis']",UNK,MODERNA, 1079655,CO,64.0,F,"Face, neck, and ears became flushed within 5 minutes of the injection. Remained red for approximately one hour.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,Claritin,none,"Asthma, overweight, hyperlipidemia",,"Multiple (over a dozen) allergies/reactions to medications, cosmetics. No food allergies.","['Flushing', 'Immediate post-injection reaction']",UNK,JANSSEN,IM 1079662,MD,72.0,F,"shot given 3-5-21 3-7-21 at 2:00 am was woken up by bad muscle and joint pains. But I was freezing. I had the chills very badly I sleep with an electric blanket, but I had not had chills in years. I was very sore and cold, but did not do anything until 4:00am. I went and got an expired prescription of oxycontin. I took 2 and went back to bed. I woke up at 6 and was fine. So it lasted maybe 4 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/07/2021,2.0,OTH,lisinapril,none,high blood pressure,,sulfa,"['Arthralgia', 'Chills', 'Feeling cold', 'Myalgia', 'Pain']",1,JANSSEN,JET 1079666,UT,63.0,F,"Headache, extreme fatigue, diarhea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,PHM,Nuvigil Levothyroxin Tylenol Arthritis Ibuprofen Caltrate Vit D Centrum Silver B12,None,Narcolepsy Hypothyroid Arthritis Maybe not important but had gastric bypass a few years ago.,,Dilantin Aspirin Eggs,"['Diarrhoea', 'Fatigue', 'Headache']",1,JANSSEN,IM 1079669,CT,29.0,M,"Chills woke me up at 5am, kept me up for at least an hour. Headache, pain in eyes, fever continued through the day. Muscle pain in back significantly worse than previous days",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/07/2021,1.0,PVT,None,Back pain (pulled muscle a few days ago),"Scoliosis, Psoriasis",,None known,"['Chills', 'Eye pain', 'Headache', 'Myalgia', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1079689,TX,19.0,F,"Fever (99 degrees), headache, fatigue, muscle aches, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,Benlafaxine HCL ER 37.5 MG Vitamin D supplements,None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,JANSSEN,SYR 1079708,IA,42.0,M,"have been extremely fatigued, headaches, muscle aches, swelling in my fingers (joints), weak, dizzy, weird feeling in my chest",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,UNK,none,"positive for covid on 12/16/20, have still been having long hauler symptoms at time of vaccination.",none,,sulfa,"['Asthenia', 'Chest discomfort', 'Dizziness', 'Fatigue', 'Headache', 'Joint swelling', 'Myalgia']",UNK,JANSSEN,UN 1079710,CT,38.0,F,"Immediately began to feel a headache, dizzy and nauseated. The doctor on site had me lie down on the floor. Was starting to feel better so was able to sit up in a chair for about 15 minutes. Another wave of dizziness and nausea came over and was lying on the floor again. It was hard to breathe, but oxygen and HR were good. The doctor tried to give me juice to see if it was my blood sugar going low, but afterward, I still felt dizzy and nauseated. It was still hard to breathe. It felt like something was sitting on my chest. BP was elevated, oxygen levels were good, HR was good but I started to get a cold chill where my teeth were chattering. At that point (about 45 min to an hour) the symptoms had not gone away and the ambulance was called. Was transported to the local hospital where I received a liter of saline and Zofran for nausea. BP was high, but oxygen levels and HR were good. The heart monitor showed no signs of arrhythmia or tachycardia so I was discharged. The doctor believes it was a side effect and not an allergic reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,WRK,"Lansoprazole, Vitamin",None,"Asthma, Acid Reflux",,Magnevist (MRI dye),"['Blood pressure increased', 'Chest discomfort', 'Chills', 'Dizziness', 'Dyspnoea', 'Headache', 'Nausea']",1,JANSSEN,SYR 1079714,VA,65.0,F,"I was experiencing a mild RA flare w/ tendinitis going into the vaccine sequence. After 2nd dose my flare worsened to severe within a 9 day period. I had joint, muscle pain, swelling of fingers, hands. I lost much mobility, having gait issues and could not walk unaided ( a first in a flare). I do not take immunosuppressive infusions. Just NSAIDs. My doctor prescribed a week of Prednisone. I am improving but having to build up strength to stand and walk. My flare continues but is abated. My muscles are weak.",Not Reported,,Not Reported,Not Reported,,Yes,U,02/17/2021,02/18/2021,1.0,PVT,Levothyroxyn Naproxen Atorvastatin Zyrtec Cranberry gel,Rheumatoid Arthritis,Rheumatoid Arthritis. Intermittent,,Sulfadrugs,"['Arthralgia', 'Gait disturbance', 'Mobility decreased', 'Muscular weakness', 'Myalgia', 'Peripheral swelling', 'Rheumatoid arthritis', 'Tendonitis']",2,MODERNA,SYR 1079717,CO,38.0,M,"Told to include this information in this box: Janssen COVID-19 Vaccine EUA Symptoms: Fatigue, nausea, body aches (entire body, but especially hips and injection site), and temperature between 98.5F-99.8F all day on the first day following the day of injection. Tylenol taken once and Advil taken twice throughout the day, which mostly relieved symptoms. Second day following day of injection, moderate fatigue in the afternoon, even after full 8 hour sleep with CPAP on all night.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/06/2021,1.0,PVT,I took 400 mg ibuprofen about 25 minutes prior to the vaccination,none,"Have had a BMI of 32 or so since I was around 16, so technically obese, though I sure haven't ever felt that way and I have always been able to meet any physical demand",,Sulpha based drugs. Hive like reaction. Have not had a sulpha based drug since I was 6 months old,"['Continuous positive airway pressure', 'Fatigue', 'Injection site pain', 'Nausea', 'Pain']",1,JANSSEN,IM 1079727,NJ,64.0,F,"Day 4 became short of breath and continued to increase each day until hospitalized on March 3, 2021. Wheezing, poor response to home meds. Oxygen sat was lowest 88. Dr thought this reaction was due to prior lung infection 2018 (ARDS - staph pneumonia).",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/24/2021,02/28/2021,4.0,PVT,,,"history of ARDS -2018 (requiring 3 weeks in ICU, intubated) diabetes, obesity, trachea malacia, pancreatic insufficiency, hyper-parathyroid",,"tree nuts, kiwi, latex. no meds","['Blood test', 'Chest X-ray', 'Computerised tomogram head', 'Computerised tomogram neck', 'Computerised tomogram thorax', 'Condition aggravated', 'Dyspnoea', 'Echocardiogram', 'Oxygen saturation decreased', 'Walking distance test', 'Wheezing']",2,MODERNA,SYR 1079731,MD,57.0,F,"After receiving the vaccine I had some common side effects such as nausea, vomiting, fever, chills, achiness, and headache, but after several hours I tried to get out of bed and I lost consciousness. In addition I had two episodes of intense sweating and dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,"celexa, biotin, Calcium/magnesiumzinc, alpha lipoic acid, Airborne",none,none,I had a very strong reaction to the Shingrix vaccine,"cats, mold, pollen","['Chills', 'Dizziness', 'Headache', 'Hyperhidrosis', 'Loss of consciousness', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",1,JANSSEN,IM 1079741,VA,35.0,F,"Fever, chills, nausea, body aches, chest pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,OTH,None,None,Prolapse valve defect,,Decongestants,"['Chest pain', 'Chills', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN, 1079751,NV,71.0,F,"On Saturday, Feb 20th, I lost hearing in my right ear. It continued for 10 days. On the day that I was going to make an appointment with an ENT, I could suddenly hear again. It has been almost a week now & I can still hear.",Not Reported,,Not Reported,Not Reported,,Yes,Y,02/19/2021,02/20/2021,1.0,PHM,Paroxitine 30 mg; Ezetimbe 10 mg; clopidogrel 75 mg; levothyroxine .125; meloxicam 15 mg; Allegra 180 mg; Colesevelam 625 mg x 3 daily; benazepril 20 mg; metoprolol 50mg. Cranberry pills.,,,,NKA,['Deafness unilateral'],UNK,PFIZER\BIONTECH, 1079763,CT,43.0,F,"Very bad pain in the tailbone, unsure if muscle or joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PHM,"Multivitamin, Junel",None,High cholesterol,,NKA,['Back pain'],1,JANSSEN,IM 1079768,,86.0,F,Hemorrhagic Stroke,Not Reported,,Yes,Yes,2.0,Not Reported,N,02/24/2021,03/05/2021,9.0,UNK,,,"HTN, Hyperlipidemia, Asthma",,NKA,"['Angiogram cerebral', 'Arteriogram carotid', 'Computerised tomogram head', 'Haemorrhagic stroke']",1,MODERNA,IM 1079787,AZ,62.0,F,Fever Body aches Chills Lasted for 24 hours following vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,Mirtazapine 30mg Probiotic,1 week before 2 days of fever and nausea ( non COVID),None,,None,"['Pain', 'Pyrexia']",UNK,JANSSEN, 1079789,CT,40.0,M,Fever: 102.3 last night Aches: all over Headache Fever 101.1 this evening and continued headache and general malaise.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,WRK,None.,None.,None.,,None.,"['Headache', 'Malaise', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1079796,NC,61.0,F,"Within 4 hours: extreme fatigue, headache, loose stools continued until 8am 3/7/2021. Itching all over body, without hives, from 2pm 3/7/2021 until 6:45pm 3/7/2021 - unsure itching is over.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/05/2021,03/05/2021,0.0,PUB,"Vitamin D, Probiotic, Advil Cold & Sinus, Cranberry, Imodium",none,"asthma, celiac, COPD, Raynaud's, osteoporosis, osteoarthritis","Influenza, hives itching of face and neck, 2013?","Bactrim, Penicillin, Clindamycin, wheat, barley, rye (celiac)","['Diarrhoea', 'Fatigue', 'Headache', 'Pruritus']",1,JANSSEN,SYR 1079797,CA,29.0,F,Face swelling Face and lip tingling Dizziness and weakness,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,MIL,Cymbalta Naproxen Multi Vitamin Glucosamine with Chondroitin Turmeric,,Femoral Acetabular Impingement of the Left Hip with labral tear,,None,"['Asthenia', 'Dizziness', 'Paraesthesia oral', 'Swelling face']",1,JANSSEN,IM 1079802,NM,37.0,F,My eyes swelled shut for two days is extremely painful now the inside of my eye is so red you can't tell what color my eyes are and they are painful and super sensitive to any light,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/04/2021,0.0,PVT,Hydroxyzine levothyroxine clonazepam,Diabetes,Diabetes,,Tramadol haldol torodol,"['Eye pain', 'Eye swelling', 'Ocular hyperaemia', 'Photophobia']",1,JANSSEN,IM 1079817,MO,60.0,F,30-40 min severe dizziness- ambulance called on way home from driving,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/01/2021,03/07/2021,6.0,OTH,Kaitlib FE Thyroxin Claritin Probiotic Mg B2 Flonase Pantropizole Levoquin,Sinus infection Ocular rosacea Conjunctivitis,Low thyroid Migraine with aura (vertigo). Haven?t had vertigo for over a year Car accident,,PCN Sulfa Prednisone Cefnidir Latex,['Dizziness'],1,JANSSEN,SYR 1079818,SC,53.0,F,"Anaphylaxis. Onset 10 minutes. Initially responsive to epinephrine, subsequently not. Ultimately requiring endotracheal intubation",Not Reported,,Yes,Yes,3.0,Not Reported,Y,03/05/2021,03/05/2021,0.0,PVT,,,"DM, OSA",,"codeine, mushroom, myrbetriq, sulfa, tetracycline","['Anaphylactic reaction', 'Endotracheal intubation']",1,MODERNA,IM 1079821,CO,63.0,F,Fast heartbeat and moderate to severe dizziness began at 3:30 PM on March 6. Fast heartbeat slowed considerably after 10:30 pm. Dizziness is mild to moderate as of 5:00 pm March 7. I am reporting this simply because it said we should make you aware of adverse events with the vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,OTH,"Levothyroxine 100 MCG, calcium 1200 MG, vitamin D3 4000 IU, biotin 5000 MCG","Sinus drainage, sore throat, wet cough 2/24; tested negative COVID, symptoms resolved 2/25","Back pain, hypothyroidism, skin cancer, emphysema, muscle cramping, trouble with concentration,",,"Allergy to erythromycin and sulfa; Severe side effects to nortriptyline, Clindamycin, and Ciproflaxen","['Dizziness', 'Heart rate increased']",1,JANSSEN,IM 1079837,,82.0,M,"Severe shortness of breath, and decrease in oxygen saturation to 61%, 2 weeks after second Covid Vaccine dose. He was rushed to the hospital and was diagnosed with pulmonary embolism and received oxygen therapy. He also received Lovenox injections and then apixaban orally.",Not Reported,,Yes,Yes,5.0,Yes,N,01/19/2021,02/02/2021,14.0,SEN,,,,,,"['Computerised tomogram abnormal', 'Dyspnoea', 'Fibrin D dimer increased', 'Oxygen saturation decreased', 'Pulmonary embolism']",2,PFIZER\BIONTECH,IM 1079849,IN,73.0,M,Bradycardia with syncopal episodes and heart rate down to 26. Patient's baseline heart rate typically 64. Patient required a pacemaker.,Not Reported,,Yes,Yes,6.0,Not Reported,Y,02/12/2021,02/13/2021,1.0,UNK,Metoprolol Voltaren Lyrica Tramadol,,HTN OA Obesity Neuropathy Atrial fibrillation (remote),,,"['Bradycardia', 'Cardiac pacemaker insertion', 'Heart rate decreased', 'Syncope']",UNK,PFIZER\BIONTECH,ID 1079851,TX,38.0,F,"After she got the vaccine, she felt dizzy, nauseated and about to faint, her finger was rigid and unable to extend on her left hand (where she got her vaccines on)",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/07/2021,0.0,PHM,,,,,,"['Dizziness', 'Muscle rigidity', 'Nausea', 'Presyncope']",,JANSSEN,IM 1079861,NE,47.0,F,low grade fever 99.9 for 12 hours muscle/body aches for 12 hours tired for 12 hours+ headache for 12 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,WRK,,none,none,,none,"['Headache', 'Myalgia', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1079864,CA,83.0,M,"9 days after receiving vaccine, pt developed rapid onset of ascending paralysis. No use of legs, minimal use of right arm. Limited use of left arm. Repiratory difficulty/failure.",Not Reported,,Yes,Yes,,Yes,N,02/23/2021,03/04/2021,9.0,PVT,None.,Recovering from Guillain-Barre Syndrome triggered by COVID December 2020. Was ambulatory again at the time of vaccination.,h/o CAD. s/p CABG x 5 10 years ago.,,Abalone.,"['CSF protein increased', 'Dyspnoea', 'Guillain-Barre syndrome', 'Magnetic resonance imaging normal', 'Musculoskeletal disorder', 'Respiratory failure']",1,PFIZER\BIONTECH,IM 1079878,OH,48.0,M,"Jansen COVID-19 Vaccine EUA I got strange sensations in the back of my neck, then later on in the day I have numbness in the back of my neck and some fin the upper back and shoulders. Don't know how much more will go numb and how bad it will get. But I can feel the back of my neck and shoulders and upper back, but it is like there is a layer in between that is numb.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,PHM,"Risperdal, Trilepta, Latuda, Losartan, vitamin D, Lovastatin, Tramadol, Buspirone, Tizanidine, Diclofenac, Hydrochlorathdizide",None,"Paralyzed right arm, bi-polar",,"penicillin, Tylox","['Hypoaesthesia', 'Sensory disturbance']",1,JANSSEN,SYR 1079895,,22.0,M,"Hives breakout all over face and arms - I've been taking Benadryl but still present, swelling on eyelids so I could barely open eyes - Been taking benadryl, Fever of 105.3 degrees - Been taking tylenol for 2 days but still have fever, Sore arm and body aches, Overall weakness feeling",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,WRK,,,,,,"['Asthenia', 'Pain', 'Pain in extremity', 'Pyrexia', 'Swelling of eyelid', 'Urticaria']",1,JANSSEN,SYR 1079896,MI,70.0,F,"After the first vaccine, patient stated she had chest and throat tightness for 7 days. After the second vaccine, 5 minutes later, patient stated she had severe dizziness, shortness of breath, fainted, shaking, elevated blood pressure to 161/70, passed out. A facility called 911 for the patient. Patient was taken to the emergency room and treated with Ativan and meclizine. 2 EKGs and CXR in ER were normal. Patient spend 1 night in the hospital. The next day, all symptoms returned. Patient was treated with benadryl, zofran, and meclizine. Patient is still taking meclizine for dizziness. Patient was treated as an outpatient with oral steroids. 2 weeks later, patient is still havng symptoms, but milder.",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/20/2021,01/21/2021,1.0,UNK,,,,,,"['Blood pressure increased', 'Chest X-ray normal', 'Chest discomfort', 'Dizziness', 'Dyspnoea', 'Electrocardiogram normal', 'Loss of consciousness', 'Syncope', 'Throat tightness', 'Tremor']",2,MODERNA,IM 1079904,CA,60.0,U,SUBJECT WAS FOUND DECEASED ON 22 FEB 2021 AT AROUND 11:30 PM,Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/22/2021,5.0,OTH,UNKNOWN,UNKNOWN,UNKNOWN,,UNKNOWN,['Death'],UNK,MODERNA, 1079914,NY,70.0,M,Janssen COVID-19 Vaccine EUA. Joint and muscle soreness for approximately six hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,none,none,arthritis,,none,"['Arthralgia', 'Myalgia']",UNK,JANSSEN,SYR 1079917,OH,62.0,F,"Fever, chills, dry sore throat, headache, body and joint pain, nausea starting 5 hours after vaccination and lasting at least 12 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,None,None,None,,Penicillin,"['Arthralgia', 'Chills', 'Dry throat', 'Headache', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1079920,CO,22.0,F,"I felt no affects after I received the shot at 2:30 PM. Woke up with chills, violent shivering, became sick to my stomach at 2 AM. I fell back to sleep an hour later after covering myself with another blanket and throwing up. My Apple Watch shows at 4 AM my heart rate rose to 127 BPM when I was asleep. It is now 6 PM and I am feeling body aches, headache, stuffy nose, still a bit nauseous-- almost like cold symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/07/2021,1.0,PUB,Lutera (birth control),,,,Amoxicillan,"['Abdominal discomfort', 'Chills', 'Headache', 'Heart rate increased', 'Nasal congestion', 'Nausea', 'Pain', 'Vomiting']",1,JANSSEN,IM 1079930,MD,50.0,F,Female 50y/o Drove (4 hour drive) with her husband and son. She only ate breakfast and some snacks. Received vaccine at approx. 3:30 pm. She did have a fear of injections but said she was extremely happy because she hardly felt any pain from the injection. Shortly after sitting down for observation she began to feel extremely dizzy. observed her condition and immediately attended to her. Fanning her to give her air and allowing her to lay her head back. informed of the need for someone to assist. After 15 minutes of the woman still not feeling better we decided to call for paramedics. Paramedics arrived in 10 minute took vitals. Glucose 132. O2 sat 100%. BP 120/80. Vitals were all good but patient still extremely nauseous and dizzy. Emt's administered oxygen and ice pack to neck. Woman began to become more alert and was responding better to questions. Due to her positive vitals the emts felt comfortable about leaving her after 15 minutes of oxygen treatment. Her husband and son walked her out.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,WRK,,,,,,"['Blood glucose', 'Blood pressure measurement', 'Dizziness', 'Nausea', 'Oxygen saturation', 'Oxygen therapy']",1,JANSSEN,IM 1079934,MA,36.0,F,"Slight fever began around 4:30pm and I took Tylenol Had chills for about a half hour Around 5pm, I noticed my heart rate was elevated (avg. of 110) and I could feel palpitations while resting Felt well enough to eat dinner at 6pm I kept tracking heart rate and it continued to increase while at rest for prolonged period (120+) When it got into the 130s, went to the ER (around 7:45pm) to check for atrial fibrillation as I was still feeling palpitations Upon arrival, my heart rate was in the 150's. Was given IV fluids and IV metoprolol tartrate Heart rate came down to 120's While at the ER, I began to feel much worse Extremely nauseous and had chills Was barely Temperature reached 104.5 (rectal) around 10:00pm Given acetaminophen at 10:19pm Temperature came down Chills went away I was discharged around 12:00am",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,Metoprolol Mirena,None,Atrial Fibrillation since 11/2020,,None,"['Blood culture', 'Chest X-ray', 'Chills', 'Electrocardiogram', 'Heart rate increased', 'Laboratory test', 'Nausea', 'Palpitations', 'Pyrexia']",1,JANSSEN,SYR 1079958,CA,68.0,F,"Pt found down and pulseless in home by husband. EMS called, Pt found to be in PEA arrest. Pt achieved ROSC with CPR and Epinephrin. Pt Passed away on 09/07/2021 at 1330. Pt was in multisystem organ failure.",Yes,03/07/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,PVT,"Atenolol, Oxycodone, Pepcid, Prevacid, Tessalon Perles, Trospium, Gabapentin, MEthotrexate, Plaquenil, Prilosec,",,"HTN, RN, GERD, Potherpetic Neurology, GERD, Metatarsalgia, Knee joint Pain, Detrusor Instability, Viral meninigitis,",,"Lime, PCN, Septra","['Death', 'Multiple organ dysfunction syndrome', 'Pulse absent', 'Pulseless electrical activity', 'Resuscitation']",1,MODERNA, 1079967,NC,56.0,F,"Patient received her covid vaccination at 1950, right deltoid. She was escorted to the 30 minute waiting zone as she has had anaphylactic reactions in the past. At 2008 patient stated she felt hot. She had a rash developing on her neck, noted a dry mouth and thickening tongue. EMS brought in for evaluation. Blood pressure 204/102, pulse 65, oxygen 100% on 2L nasal cannula. 50 mg benadryl administered IM left deltoid 2011. 20g PIV started left antecubital, 125 mg administered. Ambulance on site. Patient able to speak clearly, verbalized the need to void her bladder. Patient accompanied by 2 RNs to the restroom. She was stable on her feet, escorted back to EMS stretcher. She was taken to hospital. VAERS submitted.",Not Reported,,Not Reported,Yes,,Not Reported,U,03/07/2021,03/07/2021,0.0,OTH,"levothyroxine 75 mcg, olmesartan-hydrochlorothiazide 40-25 mg, metoprolol 50 mg, montelukast 10 mg, loratadine 10 mg,",hypertension,"hypertension, asthma, allergy with anaphylaxis",,"peanuts, dilaudid, morphine, phenergan","['Dry mouth', 'Feeling hot', 'Micturition urgency', 'Rash', 'Tongue disorder']",1,PFIZER\BIONTECH,IM 1079972,NE,24.0,F,"Headache, body aches, fever, hot flashes, chills, high heart rate",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,SCH,,,,,,"['Chills', 'Headache', 'Heart rate increased', 'Hot flush', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1079976,NY,44.0,M,"12/23/20 (Moderna #1) - Malaise, cough on 12/24, went to walk-in on 12/25 c/o cough, malaise, rx'd Augmentin x14d, Rapid covid negative (and PCR resulted negative). 12/27 slept all day, 12/28 back to work. 1/12/21 metallic taste in mouth, severe GI sx, malaise, aches, headache. 1/14 seen at walk-in and covid swabbed Negative. 1/21/21 exposed to parents who found out they were covid + on 1/22/21. 1/25/21 (Moderna #2) - Continued with persistent cough and GI sx. Then also developed urinary frequency and urgency. Seen at urgent care 2/1 c/o cough, dx URI, rx'd augmenting. Woke up morning of 2/2/21 abruptly, stood up, said something was wrong, and collapsed. CPR attempted immediately, EMS brought him to ER where he was pronounced dead.",Yes,02/02/2021,Yes,Not Reported,,Not Reported,N,12/23/2020,12/23/2020,0.0,UNK,"After 1st vaccination (12/23/20): Triamterene/HCTZ, Losinopril, DayQuil, Mucinex, prescribed Augmentin 12/25/20 After 2nd (1/25/21): Addition of Zinc, Quercetin, Vitamin C, Augmentin rx'd 2/1/21",,HTN,,None,"['Cough', 'Death', 'Dysgeusia', 'Exposure to SARS-CoV-2', 'Feeling abnormal', 'Gastrointestinal tract irritation', 'Headache', 'Malaise', 'Micturition urgency', 'Pain', 'Pollakiuria', 'Resuscitation', 'SARS-CoV-2 test negative', 'Somnolence', 'Syncope', 'Upper respiratory tract infection']",2,MODERNA,IM 1079977,CA,36.0,M,"During 15-minute observation period, patient said he was thirsty and want to get a bottle of water. Atfer getting water, patient felt dizziness and was about to faint. We called 911 and monitored him until EMT team came. Patient was still conscious and said he felt dizzy, sweating due to potential low blood sugar and asked for a sip of gatorade. Then he started felling better after that and he said it happened before during his MRI and other procedure. EMT team accessed his vital signs and symptoms inside their vehicle and finally released him home. His family took him home",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PHM,"Not listed on file, new patient to pharmacy",not listed on consent form,not listed on consent form,similar reactions with MRI in the past,penicillin,"['Dizziness', 'Hyperhidrosis', 'Thirst']",1,JANSSEN,IM 1079994,NY,60.0,F,Onset approximately 12 hours p vaccination. Low grade temp. 99.4 � (normal baseline 97.3) Chills (mild to moderate) Headache (mild to moderate) Neuralgia (mild to moderate) Tinnitus (moderate) Muscle aches (moderate) Site tenderness (mild) Cough (intermittent),Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,PUB,Imatinib Vitamin D3 Multi-vitamin Vitamin B12,GIST asthma,Asthma Cancer (GIST) TOS neutropenia Possible kidney dysfunction,,Iodine Contrast dye Lidocaine Goat cheese Red or purple onion Bean sprouts,"['Chills', 'Cough', 'Headache', 'Injection site pain', 'Myalgia', 'Neuralgia', 'Pyrexia', 'SARS-CoV-2 test', 'Tinnitus']",1,JANSSEN,IM 1079995,IL,36.0,M,"Ith the first vaccination I had upset stomach and clamy forehead about an hour after vaccination. Then within a 3 week time period I kept getting sicker then, the day after my second dose (which caused me no reaction, which I thought was weird as everyone reported that one having more side effects) I had become so sick that I went to the ER and found I had diabetic ketoacidosis. It runs in my family to have type 2 but later in life. What was also strange is that Inhad a physical not long before the vaccine through my PCP Dr. and my A1C labs came back elevated but within normal limits....",Not Reported,,Yes,Yes,5.0,Not Reported,Y,01/15/2021,01/15/2021,0.0,OTH,Blood pressure medication Amlodipine,None,None,,Allergic to cats and some pollens,"['Abdominal discomfort', 'Cold sweat', 'Diabetic ketoacidosis', 'Glycosylated haemoglobin increased', 'Intensive care', 'Malaise']",2,MODERNA,SYR 1079997,SC,39.0,F,"Arms/hands and legs/feet feeling tingly, weightless or as they?re falling asleep.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,PHM,None,None,None,,None,"['Hypoaesthesia', 'Paraesthesia']",1,JANSSEN,SYR 1080001,,,U,"8 hours after vaccination with Johnson and Johnson brand , the fever started, its now 32 hours passed and the fever does not go away and it somewhat under control with ibuprofen and acetaminophen",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Pyrexia'],UNK,JANSSEN, 1080004,CA,65.0,M,"After the initial 3 days of post injection recovery, started feeling that my lung capacity was sub-normal when walking. Stated running a low grade fever. ON about Feb 24, symptoms included chills, fever reaching 101. Ran several tests at the clinic, and finally got admitted in hospital for more tests on March 04, released on March 05",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/08/2021,02/24/2021,16.0,PVT,Lantus Solostar 9u/daily metformin 500mg 2xdaily pioglitazone 30mg 1x Lisinopril 12/HCTZ12.5 combo 1x daily vitamin B12 500mg 1x daily vitamin D 500mcg 1x daily,none,Diabetes type II controlled A1C in the 6.6 to 7.0 range CKD stage 2,,none,"['Blood test', 'Cardiac stress test', 'Chills', 'Computerised tomogram thorax', 'Dyspnoea', 'Echocardiogram', 'Pyrexia', 'Scan with contrast']",2,MODERNA,IM 1080011,FL,34.0,F,"Severe headaches on the left side of head causing eye pain , temperature of 100.1, tingling throughout my whole body including fingers and toes, extreme fatigue. All symptoms started at approximately 2:00am the day after vaccination when I woke up in the middle of the night.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,PVT,Vyvanse Max alt,None,High cholesterol Migraines ADHD,,None,"['Body temperature increased', 'Eye pain', 'Fatigue', 'Headache', 'Paraesthesia', 'Sleep disorder']",1,JANSSEN,SYR 1080033,MN,93.0,M,"COVID symptoms started within 8-9 days of vaccination. No fever, general not feeling, chills. Turned into very difficult breathing, low oxygen levels and pneumonia. Tested positive for COVID at Hospital ER on Wednesday, January 27. Died in the hospital Saturday morning, January 30, 2021.",Yes,01/30/2021,Not Reported,Yes,3.0,Not Reported,N,01/14/2021,01/22/2021,8.0,SEN,Unknown,None,,,Aspirin,"['COVID-19', 'COVID-19 pneumonia', 'Chest X-ray abnormal', 'Chills', 'Death', 'Dyspnoea', 'Oxygen saturation decreased', 'Pneumonia', 'SARS-CoV-2 test positive']",1,MODERNA,SYR 1080034,CA,70.0,M,"Temperature - 102.2 Headache, extremely tired",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,PHM,"Suboxone, Xanax, Wellbutrin, Advil",,Chronic pain - back injury,,,"['Body temperature increased', 'Fatigue', 'Headache']",1,JANSSEN,IM 1080039,OK,41.0,F,Mild fever Headache Scratchy throat,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/07/2021,1.0,SCH,Fluoxetine Colace Probiotic Multivitamin Magnesium Vitamin D Claritin,N/a,N/a,,N/a,"['Headache', 'Pyrexia', 'Throat irritation']",UNK,JANSSEN,SYR 1080050,VA,40.0,F,Low grade fever and fatigue started around 7:30pm followed by severe chills. Woke up the next morning around 8am with headache that went away after a couple hours. Felt great the rest of the day with slight soreness at the injection site.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PUB,Zoloft,,,,,"['Chills', 'Fatigue', 'Headache', 'Injection site discomfort', 'Pyrexia']",UNK,JANSSEN,SYR 1080053,MD,32.0,F,"Chills, shaking, headache, body aches, fever 101.5, fatigue. Chills and shaking started around 1:00 am without fever, lasted about 1.5 hours. Woke up at 6:00 am with severe headache, body aches, and fever. Fever resolved with Tylenol and reoccurred later around 6:00 pm at 100.4 along with body aches and chills. Headache has persisted the entire day.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,PHM,OTC Prenatal vitamins,Vaginal labor and delivery 2/5/21,,,,"['Chills', 'Headache', 'Pain', 'Pyrexia', 'Tremor']",UNK,JANSSEN,SYR 1080056,CO,37.0,F,"Severe shivering, muscle and joint pain, head ache, fever of 103.4 F",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PUB,,No,No,,,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Pyrexia']",UNK,JANSSEN,IM 1080062,CT,43.0,M,"Within 48 hours of receiving the COVID vaccine, I began having extreme pressure and discomfort in my right ear. Symptoms included dizziness, fullness in the ear and hearing loss. This persisted for several days. As a first course of action, I took Tylenol and antihistamines. I saw my PCP a few days later and he misdiagnosed my condition and suggested that I continue with antihistamines and Flonase. Two weeks later my condition had improved only slightly and I became more concerned. I asked my PCP whether a short course of steroids was warranted (at the suggestion of my mom and wife, who are both health care professionals). He prescribed a ""dose pack,"" which I started on or about Monday, Feb. 22. Later that week, I connected with an ENT who is a friend of a friend . When I told him my story and symptoms he was extremely concerned and got me an immediate appointment on Friday, Feb. 26. At that visit I was diagnosed with acute and severe Sensorineural hearing loss (SNHL) that had resulted in 92% hearing loss in my right ear. Additional symptoms continue to include fullness, tinnitus and other discomfort. None of these issues existed prior to my COVID vaccine shot. I am currently undergoing a treatment of high dose prednisone and steroid injections in my ear. I am scheduled for another visit with doctor on Friday, March 12.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/28/2021,01/30/2021,2.0,PUB,"Imuran (50), Colazal",None,Crohn's Disease,,None,"['Acoustic stimulation tests', 'Deafness neurosensory', 'Deafness unilateral', 'Dizziness', 'Ear discomfort', 'Tinnitus']",1,MODERNA,IM 1080074,MO,34.0,F,"Janssen COVID-19 Vaccine EUA 101 degree Fahrenheit fever, shaking from chills, nauseous, headache. Injection occurred 9:40am. Symptoms began 6 hours after injection (4:00 pm). Got better with some Tylenol. Symptoms came back just as bad 5 hours later (9:00pm). Took more Tylenol at 9:30 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,PHM,,,,,,"['Chills', 'Headache', 'Nausea', 'Pyrexia']",1,JANSSEN,SYR 1080075,WA,61.0,M,Hemorrhagic stroke. = Death,Yes,02/28/2021,Not Reported,Yes,,Not Reported,N,02/25/2021,02/25/2021,0.0,MIL,Metformin,,Diabetes,,Kiwi,"['Computerised tomogram head', 'Death', 'Haemorrhagic stroke']",1,MODERNA,SYR 1080231,FL,40.0,F,"Dizzy, run down two hours after injection. Woke up 4 am then off and on with extreme body pain, sore neck , lower back, right hand and arm. Headache and fatigue at 6:45 am got up with two children (2 yrs and 10 months) ate small breakfast by 9 am I couldn?t get off the couch or stay awake. My head started aching and my eyes hurt, I felt extreme chills two thick blankets weren?t enough to warm me. Extreme fatigue, stomach pain and loss of appetite. I fell asleep and didnt have the energy to walk to my bed until 2:30 pm. It set off my stomach and I was vomiting off and on until around 9 pm. By then I could keep little bits of fluid and food down. Then I was hot. I felt flushed but had no fever. My usual heart rate is 52-54 bpm via Watch while laying down. My heart rate during this hot period laying in bed was 102 -101 bpm. Which is consistent for my workout heart rate. I went to sleep and woke up 7 am with my kids and was well enough to take care of them but not do all my usual chores. I couldn?t bend down or put my head lower than chest or the extreme throbbing headache was back. Still had body aches and fatigue but nowhere near yesterday. It is 11:22 pm Sunday and I feel spent.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,UNK,None,None,"Asthma, moderate allergies, adenocarcinoma cancer",Same as this just lasted few days - HPV vaccine 2014,"Latex, opioids, pollen, pet dander","['Abdominal pain upper', 'Asthenia', 'Back pain', 'Chills', 'Decreased appetite', 'Dizziness', 'Eye pain', 'Fatigue', 'Feeling cold', 'Feeling hot', 'Flushing', 'Headache', 'Loss of personal independence in daily activities', 'Neck pain', 'Pain', 'Pain in extremity', 'Vomiting']",1,JANSSEN,IM 1080238,IL,58.0,F,"I smelled a dirty, smelly gym shoe odor on my skin earlier this evening. My partner did not smell it, and I stopped smelling the odor after about 4 hours. My sense of smell is not otherwise affected. I am still feeling occassional muscle pain in both arms 3 days after the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/07/2021,3.0,WRK,"Rosuvastatin, Fluticasone, Lanto probiotic, Align probiotic, vitamin D3, Centrum, EPA/DHA fish oil, stinging nettle, zinc pollinate, Glucosamine with MSM, Chondroitin",,"GERD, high cholesterol",,Vicodin,"['Myalgia', 'Parosmia']",1,JANSSEN,IM 1080244,DC,18.0,F,"5 hours after injection I came down with intense chills and a high fever (between 102 and 105) which lasted all night and all day the following day. Fever did not break all through the night, despite taking multiple ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/03/2021,03/03/2021,0.0,PUB,Spironylactone 50mg,,,,,"['Chills', 'Pyrexia']",1,JANSSEN,SYR 1080246,ME,61.0,F,"On day 2, I developed confusion and could not focus making it impossible for me to complete my work at my job. The confusion made driving dangerous. By Friday, I went to my PCP and they noticed that my blood pressure was only 90/58 and they were concerned so she told me that she was calling my cardiologist who said to reduce the dose of my Diltiazem from 180 mg daily to 120 mg daily. She also said to take a few days off of taking the Diltiazem. I have also had a serious increase in Tachycardia. That evening I went to the ED because I was so weak and couldn't breath well. I am also retaining a lot of fluid. The lab work indicated an elevated Pro-B-Natriuretic Peptide level of 227. I am still not well and each doctor I have spoken to said they believe it is due to the vaccine. I do not know if I should take the second dose.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/27/2021,02/28/2021,1.0,PUB,"Ativan, Eliquis, Diltiazem, Depakote, Lexapro, Tramadol, Xopenex EFA, Qvar, Vitamin D, Multi Vitamin, Ester C, Probiotic, Zinc, Folic Acid.",None,"Heart Arrhythmia - v-tach, lung cancer, arthritis, asthma, HO breast cancer. HO ruptured aneurysm",,"Milk, Dust, Opiate category drugs, Thimerosal, Baclofen, Capsasin, Gabapentin, Pollen","['Asthenia', 'Blood test', 'Confusional state', 'Disturbance in attention', 'Dyspnoea', 'Electrocardiogram', 'Fluid retention', 'Impaired driving ability', 'Impaired work ability', 'Prohormone brain natriuretic peptide increased', 'Tachycardia', 'X-ray']",1,PFIZER\BIONTECH,IM 1080249,CA,20.0,M,"Chills, fever, whole body aches, headache, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,PHM,None,None,Mild pulmonary hypertension,,None,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1080431,,67.0,M,"Narrative: 67 year-old male received his 1st COVID vaccine dose at a clinic on 2/25/21 at ~ 11:45am. No known prior COVID infection. No history of vaccine allergies or allergies to any component of the COVID vaccine. Does have history of allergic reactions including hives, angioedema or anaphylaxis to some medications (neomycin, Neosporin, bacitracin) and environmental allergens (yellow jackets, fir trees). Patient reported previously daily use of diphenhydramine (2 caps every morning) and kept an epi-pen on hand. The afternoon of 2/26/21, patient presented to his neighbor's house requesting assistance with an epi-pen. Neighbor reported significant swelling around tongue and lips, and ability to faintly speak. Neighbor administered epi-pen, but unsure if it worked, so administered a 2nd epi-pen. Within a minute or two after the 2nd dose, patient slumped over and became non-responsive. EMS was called and neighbor began CPR. EMS reported that patient was non-responsive upon arrival. A King airway was placed and a Lucas device used for chest compressions. Three rounds of epinephrine were administered during transport to the local emergency room. Patient remained unresponsive with evidence of PEA during transport. Arrival at the ER occurred ~ 4:25pm. On arrival patient noted to be unresponsive with CPR in progress. Dose of epinephrine administered ~ 3 minutes after arrival in ER. No femoral pulse palpable, cardiac monitor did show some electrical activity. Evaluation of oral cavity showed significant swelling of tongue. Additional dose of epinephrine given. Patient remained with no palpable central pulse and showed continued evidence of PEA. Patient was estimated to have been down > 45 minutes. Patient pronounced deceased at 4:59pm.",Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,N,02/25/2021,02/26/2021,1.0,OTH,,,,,,"['Aphasia', 'Death', 'Lip swelling', 'Pulse absent', 'Pulseless electrical activity', 'Resuscitation', 'Swollen tongue', 'Unresponsive to stimuli']",1,MODERNA,IM 1080432,,64.0,M,Death Narrative: On 3/3/21 an MSA from the Decedent Affairs Office received a call from the Office of the Chief Medical Examiner. The ME office informed the MSA that an autopsy was conducted on 3/2/21 and is pending results. No further information was given. A clinical review was conducted by the PCP but no conclusions could be made until autopsy results are received. The Office of Decedent Affairs will be reaching out periodically to the ME's office to retrieve these results. This Issue Brief will be updated by 3/17/21.,Yes,03/03/2021,Not Reported,Not Reported,,Not Reported,N,02/27/2021,03/03/2021,4.0,OTH,,,,,,"['Autopsy', 'Death']",2,PFIZER\BIONTECH, 1080433,,89.0,M,unknown cardiovascular event,Yes,02/07/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/07/2021,13.0,OTH,,,,,,['Cardiovascular disorder'],1,MODERNA,IM 1080434,,76.0,M,"Death Narrative: Patient passed away on 3-2-21, patient received the vaccine on 2-24-21. Patient was obese and had several co-morbid conditions.",Yes,03/02/2021,Not Reported,Not Reported,,Not Reported,N,02/24/2021,03/02/2021,6.0,OTH,,,,,,"['Death', 'Obesity']",1,MODERNA,IM 1080435,,62.0,M,"DEATH Narrative: 61 y.o. male with pmh afib, substance dependance, renal failure, recent admissions in the community for acute hypotension and acute kidney injury (11/2020 & 2/2021). Was found deceased in his apartment on the afternoon of 03/01/2021. Request sent to ME office for report if one exists. Patient was listed as having no known allergies.",Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,N,02/27/2021,03/01/2021,2.0,OTH,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1080133,OH,39.0,F,"injection site itching; injection site red; vaccination site awrmth; kidney infection; Low grade temperature; Arm sore; A spontaneous report was received from Physician regarding a 39 year old female who received first dose of Moderna Covid-19 vaccine and have experienced delayed skin reaction, sore arm, fever and kidney infection. The patient's medical history included botulinum toxin injection. Her concomitant medications were not provided. No information on allergies. On 29-DEC-2020, prior to the onset of events, the patient received first of two planned doses of Covid-19 vaccine intramuscularly on Left arm for the prophylaxis of Covid-19 infection (Lot number 011L20A). On 07-JAN-2021, 9 days after vaccination, patient had visited health care professional and says that her arm was sore for about 5 to 6 days after vaccination and then she felt fine. Today, she woke up with injection site itching, red (half dollar size), and hot. She has been on antibiotics for her kidney infection for the past three days. She also had low grade temperature for last three days. She was diagnosed with delayed skin reaction and report was sent to regulatory authority. She was given instructions to check temperature, axillary lymph node swelling and apply cool pack to the area and take Ibuprofen/Tylenol as directed and as needed. Patient states that she heard about these reactions in people who use Botox in the past and she had used it in the past. Action taken with the 2nd dose of vaccine in unknown. The outcome of the event sore arm was resolved on 03 Jan 2021. Other events delayed skin reaction, kidney infection and fever are not recovered at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,UNK,,,Medical History/Concurrent Conditions: Botulinum toxin injection,,,"['Kidney infection', 'Pyrexia', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site pruritus', 'Vaccination site warmth']",1,MODERNA,OT 1080134,KY,79.0,M,"Dyspnea on exertion; Acute on chronic systolic (congestive) heart failure; A spontaneous report was received from a other healthcare professional concerning a 79-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dyspnea exertional and acute on chronic systolic (congestive) heart failure. The patient's medical history, as provided by the reporter, included pulmonary fibrosis, elevated troponin, paroxysmal trial fibrillation paroxysmal (PAF), major depressive disorder, and cardiac pacemaker insertion. Concomitant medications was not provided. On 21 Jan 2021 at 11:30 am, approximately twenty two days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Feb 2021 the patient was hospitalized. Onset of the dyspnea was noted on the same date and acute cardiac failure started on 13 Feb 2021. He was discharged on 14 Feb 2021. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The events, dyspnea on exertion and acute on chronic systolic (congestive) heart failure considered was recovered/resolved.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information is requested.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/21/2021,02/12/2021,22.0,UNK,,Major depressive disorder,Medical History/Concurrent Conditions: Atrial fibrillation paroxysmal; Pacemaker insertion (cardiac); Pulmonary fibrosis; Troponin increased,,,"['Cardiac failure acute', 'Dyspnoea exertional']",1,MODERNA,OT 1080135,OR,,F,"Left shoulder really hurt; Left arm skin crinkled; Intermittent pain primarily in lower left arm and sometimes entire left side of body; Arm was sore at the injection site; Unable to go back to sleep/did not sleep well; pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful, intermittent pain primarily in lower left arm, arm sore all day; Pain in upper torso; Left side of head felt like balloon, had puffiness on left side, physically felt it, it did not feel puffy; Throat started to swell; Felt terrible/felt miserable; Soreness; Extremely tired; A spontaneous report, was received from a Consumer (patient), an 83 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced left side of head felt like balloon, had puffiness on left side, physically felt it, it did not feel puffy, throat started to swell, unable to go back to sleep, pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful, pain in upper torso upper, intermittent pain primarily in lower left arm and sometimes entire left side of body, left arm skin crinkled, felt terrible/felt miserable, soreness, extremely tired, arm was sore at the injection site, and left shoulder really hurt. The patient's medical history was not reported. No relevant concomitant medications were reported. On 06 Feb 20201, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A), intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 06 Feb 2021, the patient felt terrible right after the vaccine, and was extremely tired. The patient developed soreness which was overwhelming, and throat started to swell (felt like it lasted for an hour). The patient also reported that her left side of head felt like a balloon, then it felt like she had puffiness on the left side, but when she physically felt it, it did not feel puffy. The patient got on the exercycle for an hour. On 07 Feb 2021, the patient stayed in bed and felt miserable until 11:15 AM and got on the exercycle. On the same day, the patient was unable to go back to sleep. She had pain in left arm and upper torso which was unbearable and continued until the evening of 07 Feb 2021. On 09 Feb 2021, the patient did not sleep well and during night her arm was sore at the injection site and from elbow to wrist. On 10 Feb 2021, the patient developed intermittent pain primarily in lower left arm and sometimes in entire left side of body. On 11 Feb 2021, the patient could not sleep on her left side because of the pain. The patient's left arm skin on top was crinkled and when she held her arm horizontal to floor and was sore all day. On 12 Feb 2021, 5:45 AM, the patient could not go back to sleep as left shoulder really hurt. The patient's inner lower left arm was painful. Off and on after 12 Feb 2021, the patient arm would hurt between wrist and elbow on top. The patient had nothing on the right side. No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the events was unknown. The outcome of the events, left side of head felt like balloon, had puffiness on left side, physically felt it, it did not feel puffy, and throat started to swell, were recovered/resolved on 06 Feb 2021, event pain in upper torso was recovered/resolved on 07 Feb 2021, events unable to go back to sleep/did not sleep well, intermittent pain primarily in lower left arm and sometimes entire left side of body, left arm skin crinkled, felt terrible/felt miserable, extremely tired, arm was sore at the injection site, left shoulder really hurt, were recovered/resolved on 12 Feb 2021, events pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful, and soreness were unknown.; Reporter's Comments: Based on the information provide which includes a strong temporal association, a causal association between the reported event and the administration of the mRNA-1273 vaccine cannot be excluded. shoulder pain, vaccination site pain and tiredness are consistent with the known safety profile of vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/06/2021,02/06/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Abdominal pain upper', 'Arthralgia', 'Central pain syndrome', 'Fatigue', 'Feeling abnormal', 'Hemidysaesthesia', 'Insomnia', 'Pain', 'Pain in extremity', 'Pharyngeal swelling', 'Skin texture abnormal', 'Vaccination site pain']",1,MODERNA,OT 1080136,AL,41.0,F,"Flare up; A spontaneous report was received from a consumer concerning her daughter, a 41-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273). The patient's medical history included rheumatoid arthritis and migraine. Products known to have been used by the patient, within two weeks prior to the event, included steroid injections, antibiotics and medications for rheumatoid arthritis and migraine (not specified). On 17 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 17 Feb 2021, the pregnant patient had a flare up of her condition which is a medically significant event. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/17/2021,0.0,UNK,,Migraine; Rheumatoid arthritis,,,,['Rheumatoid arthritis'],1,MODERNA,OT 1080137,ID,,F,"liquid from the injection site was dripping through the arm; liquid from the injection site was dripping through the arm; A spontaneous report was received from a pharmacist concerning, a female patient (HCP) of unspecified age who received Moderna (mRNA-1273) vaccine and experienced an adverse event of liquid from the injection site was dripping through the arm (Vaccination site discharge and Underdose). The patient's medical history was not reported. Concomitant product use was not provided by the reporter. On 19 Feb 2021 morning, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection. On 19 Feb 2021 morning, after receiving the vaccine, the patient raised the arm and saw that liquid from the injection site was dripping through the arm. The reporter wanted to know how to proceed and if the dose could be repeated. Reporter did not have much information about patient. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event of liquid from the injection site was dripping through the arm was considered as Resolved on 19 Feb 2021.; Reporter's Comments: This case concerns a female patient of unknown age who received their first of two planned doses of mRNA-1273 (Lot # unknown), reporting Vaccination site discharge and Underdose without any associated adverse events. Event considered as resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Underdose', 'Vaccination site discharge']",1,MODERNA,OT 1080138,NY,16.0,M,"16-Year-Old Vaccinated; A spontaneous report (United States) was received from health care professional(nurse) concerning 16 years-old, male patient who received Moderna's COVID-19 Vaccine (m-RNA-1273) and administered the first dose of Moderna COVID-19 vaccine about 30 days ago by mistake; The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date in Jan 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 [Batch Number: Unknown] intramuscularly for prophylaxis of COVID-19 infection. On an unknown date in Jan 2021, a 16 year old male patient was administered the first dose of Moderna COVID-19 vaccine about 30 days ago by mistake. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, 16 year old male patient was administered the first dose of Moderna COVID-19 vaccine about 30 days ago by mistake was considered recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273. There were no reported adverse events associated with this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical History not provided),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1080139,PA,,M,"Sensation of a throat closure; Swelling of the lips; Swelling of the tongue; A spontaneous report was received from a consumer concerning a 74-year-old male patient, who experienced a sensation of throat closure, lip swelling and swelling of the tongue. The patient's medical history was not provided. No relevant concomitant medications were reported. On 16 Feb 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number:016m20a) in the left arm for prophylaxis of Covid-19 infection. The patient reported that while he was driving home less than an hour after receiving the vaccine, he started to have a sensation of a throat closure, swelling of the lips and swelling of the tongue. As he was noticing increasing reaction while time was passing by, he went to the hospital. In the ER, they gave him Decadron, Diphenhydramine (injections) and Pepcid. The following day, he visited his primary physician by advice of health care workers at the ER. Right now, he has no symptoms. No further information was provided. Treatment for the events included Decadron, Diphenhydramine(injections), and Pepcid. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events of sensation of a throat closure, lip swelling and swelling of the tongue were considered to be recovered on 16 Feb 2021.; Reporter's Comments: This case concerns a 74-year-old male who experienced Serious unexpected events of pharyngeal swelling, lip swelling, swollen tongue. The events occurred within 1 hour after the first dose of mRNA-1273. Treatment included Decadron, diphenhydramine, and Pepcid. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Lip swelling', 'Pharyngeal swelling', 'Swollen tongue']",1,MODERNA, 1080140,IN,,U,"Lost some of vaccination out of syringe; Lost some of vaccination out of syringe; A spontaneous report was received from a pharmacist concerning a patient of an unknown age and gender who received Moderna's COVID-19 Vaccine and lost some vaccination out of syringe. The patient's medical history was not provided. No concomitant medications were provided. On 19 Feb 2021, prior to onset of the event lost some vaccination out of syringe, the patient received their dose of mRNA-1273 (lot/batch number: unknown) for prophylaxis of COVID-19 infection. On 19 Feb 2021, the patient lost some vaccination out of syringe as connection between the syringe and needle was loose. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event lost some vaccination out of syringe was considered recovered.; Reporter's Comments: This reports refers to a case of Vaccine underdose AND Syringe Connection Issue for mRNA-1273 (lot number unknown) with no associated AEs. Causality for this medication error is not applic",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history provided),,,"['Device connection issue', 'Underdose']",1,MODERNA,OT 1080141,MD,,M,"Received both doses of the Moderna vaccine today 20FEB2021 within 10 minutes; A spontaneous reportwas received from a healthcare professional, concerning a 73-year-old, male patient, who received both doses of Moderna's COVID-19 Vaccine (mRNA-1273) on 20 Feb 2021 within 10 minutes/ Inappropriate schedule of product administration. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 006M20A) on 20 Feb 2021. On 20 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 006M20A) intramuscularly the left arm for prophylaxis of COVID-19 infection. On 20 Feb 2021, the patient received both doses of the Moderna vaccine within 10 minutes gap. The patient was anxious from the event but does not had side effects. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The outcome of the event was resolved/recovered on 20 Feb 2021.; Reporter's Comments: This case concerns a 73-year-old male patient who received their first and second of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate schedule of product administration without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/20/2021,02/20/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Inappropriate schedule of product administration'],2,MODERNA,OT 1080142,AZ,62.0,F,"Some of the vaccine leaked into syringe cap; Patient did not receive total dose; A spontaneous report was received from a nurse concerning a 62 years old, female patient who was administrated Moderna's COVID-19 vaccine at under dose and had a device connection issue during vaccination. The patient's medical history was not provided. No relevant concomitant medications were not reported. On 19 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. While administrating the vaccine, on 19 Feb 2021, some of the vaccine leaked into syringe cap and patient did not receive total dose. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, some of the vaccine leaked into syringe cap and patient did not receive total dose was resolved.; Reporter's Comments: This report refers to a case of device connection issue and underdose, for Moderna's COVID-19 mRNA-1273, vaccine (lot # unknown) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Device connection issue', 'Underdose']",1,MODERNA,OT 1080143,,16.0,U,"16 year old vaccinated; A spontaneous reportwas received from a Pharmacist regarding 16-year-old individual, unknown race, and ethnicity, who was administered first dose of Moderna Covid-19 vaccine on 19-FEB-2021 (Inappropriate age at vaccine administration). The patient's medical history was not provided. No concomitant medications were reported. No information on allergies. On 19-FEB-2021, individual received first of two planned doses of Moderna Covid-19 vaccine intramuscularly for the prophylaxis of Covid-19 infection. (Lot : 029L20A). It was not known whether the individual experienced any adverse event after vaccination. Action taken with 2nd dose of vaccine was not reported. The outcome of the event inappropriate age at vaccination was recovered.; Reporter's Comments: This report refers to a case of 'Inappropriate age at vaccine administration' for mRNA-1273, Lot : 029L20A with no associated AEs. Causality for the medication error is not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1080144,,,U,"subcutaneous administraion; A spontaneous report was received from a health care professional concerning a patient of unknown gender and unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) subcutaneously/Incorrect route of product administration. The patients medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of events, the patient received their second of two planned dose of mRNA-1273 (lot number: unknown) vaccine subcutaneously for prophylaxis of COVID-19 infection. On an unknown date, the patient was administered mRNA-1273 vaccine subcutaneously in the triceps area, rather than the recommended intramuscular deltoid location. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event inappropriate route of vaccination was recovered.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect route of product administration without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Incorrect route of product administration'],2,MODERNA,OT 1080145,TN,63.0,M,"Pre-existing condition of kidney failure; Pre-existing conditions of heart failure; Skin rash; A spontaneous report was received from a 63-year-old male, consumer who received Moderna Covid-19 Vaccine (mRNA-1273) and who experienced pre-existing conditions of heart failure / cardiac failure and kidney failure / renal failure. The patient's medical history, as provided by the reporter, included preexisting conditions of heart failure and kidney failure. No relevant concomitants were reported. On unk Feb 2021 (during the first week of February), prior to onset of symptoms, the patient received their first dose of two planned doses of mRNA-1273 (Lot number 026L20A) intramuscularly in the right arm for the prophylaxis of Covid-19 infection. On unknown date, the patient experienced a rash, but no other reaction. He reported taking no other medication when he had received his first dose. On 17 Feb 2021, the patient was hospitalized for his pre-existing conditions of heart failure and kidney failure. He was discharged on 21 Feb 2021. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, rash, pre-existing heart failure and kidney failure red, were not reported.; Reporter's Comments: Based on reporter's causality the serious events kidney failure and heart failure are assessed as unlikely related to mRNA-1273 but possibly related to the consumer's pre-existing conditions of renal failure and cardiac failure, while the non-serious event of rash may be possibly related to mRNA-1273.",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,02/01/2021,02/17/2021,16.0,UNK,,Heart failure; Kidney failure,,,,"['Cardiac failure', 'Rash', 'Renal failure']",1,MODERNA,OT 1080146,,,F,"drooping of the left side of her face/Bell's Palsy; very high BP; A spontaneous report was received from a consumer concerning an approximately 44-years-old female patient who received Moderna's Covid 19 vaccine (mRNA1273) and who developed Bell's Palsy (facial paralysis) and high blood pressure (BP) (hypertension). The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. The patient received first of two planned dose of mRNA-1273 intramuscularly on 19-JAN-2021 for prophylaxis of Covid 19 infection. On 22-FEB-2021 patients had a high BP of 130/80 mmHg. Patient noticed drooping of the left side of face. The patient went to the emergency room, was found to have very high BP, and was diagnosed with Bell's Palsy and was getting a CT scan. Treatment for the event included Prednisone. Action taken with mRNA-1273 in response to the events was not provided/unknown. The outcome of the event were considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,02/22/2021,34.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history provided.),,,"[""Bell's palsy"", 'Blood pressure measurement', 'Hypertension']",1,MODERNA,OT 1080147,TX,,F,"GI Bleed; Blood count dropped; A spontaneous report was received from a consumer, who was also a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a GI Bleed and her blood count dropped. The patient's medical history included high blood pressure, obesity and type 2 diabetes. Products known to have been used by the patient, within two weeks prior to the event, were Metformin and Lisinopril. The patient received their first of two planned doses of mRNA-1273 (LOT 041L20A) on 02-Feb-2021, approximately six days prior to the onset of event, intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 08-Feb-2021, patient reported having gone to the ER and was subsequently admitted to the hospital with a GI bleed. She reported that she received 10 units of blood during her hospitalization. She received 10 units of blood over the days she was in hospital, from 02-08-2021, up until 02-16-2021. Patient asks is it safe for her to get the second vaccine? She never had a GI bleed like that before. Her blood count dropped. She was discharged on 16-Feb-2021. Patient expressed concerns about receiving the second dose of mRNA-1273. No relevant laboratory details were included. Action taken with the drug in response to the event, GI bleed, was not reported. The outcome of the event, GI bleed, was considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events of GI bleed and blood count dropped, a causal relationship cannot be excluded. Patient's significant medical history included high blood pressure.",Not Reported,,Not Reported,Yes,9.0,Not Reported,Y,02/02/2021,02/08/2021,6.0,UNK,METFORMIN; LISINOPRIL,Blood pressure high; Obesity; Type 2 diabetes mellitus,,,,"['Blood count', 'Gastrointestinal haemorrhage']",1,MODERNA,OT 1080148,,79.0,F,"A-fib; Rapid heart beat; A spontaneous report was received from a consumer concerning a 79 year old, female patient who experienced rapid heartbeat and atrial fibrillation (A-fib). The patient's medical history included hypertension and renal disease. Concomitant product used were losartan potassium ,levothyroxine, fluorseminde ,levotiroxine, multivitamin, zinc , vitamin for knee joint movement, vit D3 , alpha lipoic acid, rosuvastatin calcium , elequis, milatonin , probtotic 10. On 27 JAN 2021, approximately 30 minutes prior to the onset of the symptoms, the patient received her first of two planned doses of mrna-1273, batch number was not provided, intramuscularly in an unknown injection site for the prophylaxis of COVID-19 infection. On 27th JAN 2021, after receiving the vaccine she experienced rapid heartbeat and she reached out to the pharmacy where she took the vaccine. From there the pharmacist called 911. On 27th JAN 2021 she was hospitalized, and the hospitalization prolonged for four days and discharged on 31 JAN 2021. Treatment for the event included Eliquis 5 milligrams (mg) and Metoprolol Succinate ER 25mg. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events rapid heart beat and A-fib were unknown.; Reporter's Comments: This case concerns a 79-year-old female, with medical history of hypertension, who was hospitalized with serious unexpected events of atrial fibrillation and heart rate increased. The events occurred the same day as the first dose of mRNA-1273 and were treated with Eliquis and Metoprolol. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,LOSARTAN POTASSIUM; LEVOTHYROXINE; FUROSEMIDE; MULTIVITAMIN & MINERAL; ZINC; VIT D3; ALPHA LIPOIC ACID; ROSUVASTATIN CALCIUM GENERIC; MELATONIN; PROBIOTIC 10; ELIQUIS; VITAMINS [UMBRELLA TERM],,Medical History/Concurrent Conditions: Hypertension; Renal disease,,,"['Atrial fibrillation', 'Heart rate increased']",1,MODERNA,OT 1080149,CO,,U,"approximately 0.1 mL leaked; A spontaneous report was received from a Pharmacist regarding an unidentifiable individual who was administered Moderna covid-19 vaccine and when giving the vaccine to a patient, approximately 0.1 mL leaked, so the patient received 0.4 mL (Vaccine underdose). The patient's medical history was not provided. No concomitant medications were reported. No information on allergies. On an unspecified date, prior to the onset of events, individual received (first or second dose is not specified) Moderna Covid-19 vaccine for the prophylaxis of Covid-19 infection. (Lot: Unknown). During the administration 0.1ml leaked and only 0.4 ml was given to the patient (Vaccine underdose). She wants to know if they could administer to the patient the 0.1 mL. Action taken with 2nd dose of vaccine was not reported. The outcome was resolved for event.; Reporter's Comments: This report refers to a case of a patient who was administered Moderna covid-19 vaccine and when giving the vaccine to a patient, approximately 0.1 mL leaked, (Vaccine under dose). (Lot # not provided). No associated AEs were reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Underdose'],1,MODERNA, 1080150,PA,17.0,F,"17 year old was administered the vaccine; A spontaneous report was received from a Consumer (patient's mother), concerning a 17-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events inappropriate age at vaccine administration. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection. On an unknown date, the Moderna's COVID-19 vaccine was administered to a 17-year-old female patient, resulting in inappropriate age at vaccine administration. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. At the time of this report, the outcome of the event- inappropriate age at vaccine administration was considered resolved.; Reporter's Comments: This report refers to a case of a 17-year-old female who experienced Product administered to patient of inappropriate age for mRNA-1273, lot # unknown, with no associated adverse events. Event considered resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Product administered to patient of inappropriate age'],1,MODERNA, 1080151,CA,,M,"Had Arrhythmias and skipping beats after vaccination; May have been giving 1.5 dose instead of 1 dose; A spontaneous report was received from a consumer concerning a 72 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (arrhythmia, heart rate irregular, Accidental overdose). The patient's medical history was not provided. Relevant concomitant medication included beta blocker. On 15Feb2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 15Feb2021 the patient experienced the events (arrhythmia) with seriousness criteria (medically significant). Laboratory details not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event unknown.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273 (lot # 024M20A) with associated AE reported of arrhythmia. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/15/2021,02/15/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Accidental overdose', 'Arrhythmia']",1,MODERNA,OT 1080152,AL,74.0,F,"Trigeminal neuralgia; Bell's Palsy; pain in the ear; Fatigue; Headache; A spontaneous report was received from a consumer concerning 74-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced trigeminal neuralgia, Bell's palsy, fatigue, headache, and pain in the ear. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Feb 2021, 2 days prior to the onsent of the events of fatigue and headache, the patient received their first of two planned doses of mRNA-1273(lot/batch number: 007M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, the patient experienced fatigue and headache. On 14 Feb 2021, she had swelling in her left jaw. She described it as if there was ""an abscess tooth and my side of the face swelled up as if I had the mumps."" She had facial pain and her lips were tingling and numb. Her dentist determined that she had no infection, no tooth abscess, or jaw issue to cause this extreme swelling. On an unknown date in Feb 2021, Her physician ran some tests and diagnosed her with bells palsy and trigeminal neuralgia based on examination. On an unknown date in Feb 2021, CRP (C-reactive protein) was 135.2 (0-5). From 19 Feb 2021 to 21 Feb 2021, the patient was treated with prednisone 20 mg. The patient's swelling went down and was able to open her mouth again. On 22 Feb 2021, her pain was back and she experienced severe pain in the ear to the point where it woke her up at 3:30 am and she couldn't wear her glasses either. She was taking pain medication hydrocodone 10.325 mg to help with the pain. As of 22Feb2021, her pain and swelling was back. Treatment for the pain included hydrocodone 10.325 mg. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events trigeminal neuralgia, Bell's palsy, fatigue, headache, and pain in the ear were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/13/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"[""Bell's palsy"", 'C-reactive protein', 'Ear pain', 'Fatigue', 'Headache', 'Trigeminal neuralgia']",1,MODERNA,OT 1080153,,,M,"Pulmonary insufficiency; A spontaneous report received from a Consumer concerning, an unknown age male patient who received a second dose of the Moderna COVID-19 vaccine and experienced pulmonary insufficiency. The patient's medical history was not included. Patient's concomitant was not included. On unknown date, the patient received their Second dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Reporter stated her daughter's friend apparently developed a severe reaction a day or two after receiving the second dose of the vaccine resulting in pulmonary insufficiency. He had just traveled on vacation. He is now in an ICU at a U. Medical Center and may be moved into a respirator soon because of clinical deterioration. Reporter stated two days of steroids apparently have not helped. Other treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was unknown/ not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Respiratory failure'],1,MODERNA,OT 1080154,CA,,U,"Second dose given 19 days after 1st dose; A spontaneous report was received from a pharmacist concerning a patient (age and gender unspecified) who received second dose of Moderna's COVID-19 vaccine (mRNA-1273), 19 days after 1st dose. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route of administration and unknown arm, for prophylaxis of COVID-19 infection. On 22 Feb 2021, the second dose was given 19 days after 1st dose (inappropriate schedule of vaccine administered). No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the event was not applicable. The outcome of the event second dose given 19 days after 1st dose was considered resolved.; Reporter's Comments: This report refers to a case of a consumer who received second dose for mRNA-1273 (lot # not provided) 19 days after the first dose, with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,['Inappropriate schedule of product administration'],2,MODERNA,OT 1080155,CA,17.0,F,"Patient under 18 years of age had vaccine administered; A spontaneous report was received from other healthcare professional (Nurse) concerning a 17-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 043L20A), unknown route for prophylaxis of COVID-19 infection. On 22 Jan 2021, the Moderna vaccine was administered to patient under 18 years of age. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event Moderna vaccine was administered to patient under 18 years of age was considered recovered.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 043L20A with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical History not provided),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1080156,FL,,F,"atrial fibrillation episodes; can't walk very well (limping) due to stiffness; unable to move her hands; muscles are stiff; ongoing watery diarrhea; terrible arthritis throughout her whole body; swollen armpit with a growth; sore left arm; headaches; A spontaneous report was received from a consumer who was a 73-year-old, female patient who received Moderna's covid-19 vaccine (mRNA-1273) and experienced sore left arm (vaccination site pain), headache, terrible arthritis throughout her whole body (arthralgia), unable to move her hands, muscles are stiff, ongoing watery diarrhea, a swollen armpit with a growth (vaccination site lymphadenopathy), she can't walk very well (limping) due to stiffness and atrial fibrillation episodes. The patient's medical history includes cancer of the bowels five years ago, heart problems and arthritis. Concomitant medications reported as amlodipine besylate (2.5 mg daily), rivaroxaban (20 mg daily), Preservision, organic whole food multi-vitamins, and marijuana. On 27-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of Covid-19 infection. On 27-JAN-2021, the patient reported that her left arm was sore and that she had headaches that started six hours after the injection and lasted for seven or eight days. Additionally, the patient reported several other symptoms for which the start date was unknown including arthritis throughout her entire body, the inability to move her hands, stiff muscles, watery diarrhea and a swollen armpit with a growth. She also reported that she was limping due to stiffness and was having atrial fibrillation episodes. No additional data regarding the atrial fibrillation episodes was provided. Laboratory details were not provided. Treatment for the events included paracetamol and naproxen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, headaches, was considered recovered/resolved. The outcomes of the events, sore left arm (vaccination site pain), terrible arthritis throughout her whole body (arthralgia), unable to move her hands, muscles are stiff, ongoing watery diarrhea, a swollen armpit with a growth (vaccination site lymphadenopathy), she can't walk very well (limping) due to stiffness and atrial fibrillation episodes, were considered unknown.; Reporter's Comments: This case concerns a 73 Y/O F with serious unexpected atrial fibrillation and NS unexpected diarrhea, muscular weakness, gait disturbance, musculoskeletal stiffness and NS expected arthralgia, vaccination site pain, vaccination site lymphadenopathy, headache. Event onset the same day as first dose mRNA-1273. Outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/27/2021,01/27/2021,0.0,UNK,AMLODIPINE BESYLATE; RIVAROXABAN; PRESERVISION; MULTIVITAMINS [VITAMINS NOS]; MARIJUANA,"Arthritis; Drug allergy (allergies to any medications made from oil drilled out of the earth); Heart disease, unspecified",Medical History/Concurrent Conditions: Cancer,,,"['Arthralgia', 'Atrial fibrillation', 'Diarrhoea', 'Gait disturbance', 'Headache', 'Muscular weakness', 'Musculoskeletal stiffness', 'Vaccination site lymphadenopathy', 'Vaccination site pain']",1,MODERNA,OT 1080157,SC,64.0,F,"Tested positive for Covid; Flu like symptoms; Cough; Viral rash; Chills; Fever; Sore throat; Vomiting; Vaccine was administered in the side of her arm and not in her deltoid muscle; Abdominal cramps; Diarrhea; Pain/body ache; A spontaneous report was received from a Healthcare Professional concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events abdominal cramps, pain, diarrhea, flu like symptoms, viral rash, fever, chills, cough, sore throat, body aches, vomiting, tested positive for covid. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Dec 2020, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27 Jan 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot batch: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27JAN2021 the patient received the 2nd dose of the Moderna vaccine in her left arm and reported that the vaccine was administered in the side of her arm and not in her deltoid muscle. On the same day the patient reported nausea, headache, injection site swelling, redness 2 inches below the injection site and pain. Nausea ended on 28JAN2021 and the other symptoms are ongoing On 11 Jan 2021, the patient experienced the events abdominal cramps. pain, diarrhea. On 12 Jan 2021, the patient experienced the events flu like symptoms. viral rash, fever, chills, cough, sore throat, body aches, vomiting. On 13 Jan 2021, the patient experienced the events tested positive for covid. Treatment details included Claritin and Ibuprofen Action taken with mRNA-1273 in response to the events was not reported. On 22 Jan 2021, the patient was completely recovered from abdominal cramps. pain, diarrhea, flu like symptoms. viral rash, fever, chills, cough, sore throat, body aches, vomiting and coronavirus test positive. The outcome of all events was recovered/resolved.; Reporter's Comments: This case concerns a 64 Y/O M with NS unexpected COVID-19, influenza-like symptoms, abdominal cramps, diarrhea, viral rash, sore throat, cough, and NS expected fever, chills, vomiting, pain. Onset 13 days after first dose mRNA-1273. Events resolved. Second dose mRNA-1273 with nausea, headache, injection site swelling, redness, pain. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,01/11/2021,12.0,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Abdominal pain', 'Chills', 'Coronavirus test positive', 'Cough', 'Diarrhoea', 'Influenza like illness', 'Oropharyngeal pain', 'Pain', 'Product administered at inappropriate site', 'Pyrexia', 'Viral rash', 'Vomiting']",1,MODERNA,OT 1080158,CA,69.0,F,"DIzziness; A spontaneous report was received from a consumer concerning a 69 year old, female patient who received their first of two planned doses of mRNA-1273 and experienced dizziness. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 03 Feb 2021, priorto the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch number: 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 03 Feb 2021, at night the patient complained of dizziness to her daughter. On 04 Feb 2021 the patient was admitted in hospital. Treatment for the event included Tylenol. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/03/2021,02/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Dizziness'],1,MODERNA,OT 1080159,FL,84.0,M,"Injection site area was hard; Injection site area was swollen (left arm); Vaccine not given in the deltoid muscle correctly; A spontaneous report was received from a consumer (patient), an 84 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced injection site area was hard (vaccination site induration), injection site area was swollen (left arm) (vaccination site swelling), and vaccine not given in the deltoid muscle correctly (incorrect route of product administration). The patient's medical history was not provided. No relevant concomitant medications were reported. On 09 Feb 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 031L20A), intramuscular in the left arm for the prophylaxis of COVID-19 infection. The patient was concerned that they did not give him the vaccine correctly in the deltoid muscle on 09 Feb 2021. On 10 FEB 2021, the patient experienced that the injection site area was hard like a rock and swollen, approximately five inches below the actual injection location. No further information was provided. Treatment information was unknown. Action taken with the second dose of mRNA-1273 in response to the events was not reported. The outcome for the events, injection site area was hard, injection site area was swollen was considered as unknown, that of event they did not give him the vaccine in the deltoid muscle correctly was considered recovered on 09 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Incorrect route of product administration', 'Vaccination site induration', 'Vaccination site swelling']",1,MODERNA,OT 1080160,OH,67.0,F,"Chills; pain wasn't constant it was jumping to different parts of her body; difficulty in breathing/labored breathing; tightness in the chest/chest felt tight there was a heaviness just like a feeling of discomfort; joint pain started in her right elbow, right thumb, right knee, left ankle and left instep; Feeling unwell; Muscle pain; Injection site pain; Headache; has not felt normal; Tiredness; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261), intramuscularly on 22Jan2021 09:35 at 0.3 ml single dose for COVID-19 immunization. Medical history included ongoing High cholesterol, allergies to penicillin and sulfanized antibiotics, allergies to latex, Shingles since 2007, post herpetic neuralgia, mild shingles pain from the neuralgia, changes in temperature, the temperature and the weather going up and down. No other condition was reported. Concomitant medication included rosuvastatin (strength: 10mg) from 18Jan2021 to 24Jan2021 at 10 mg for High cholesterol. Past drug event included doxycycline allergy (she had a reaction to that she was sweating profusely and had very rapid heartrate and elevated BP and unable to sleep), Ibuprofen allergy, Levaquin allergy, Valium allergy and omeprazole allergy, took sulfanized (SULFA) antibiotics allergy (she had rapid heartbeat, sweating). Patient stated she said that she had received the first dose of the COVID-19 vaccine and did experience some side effects of the COVID-19 vaccine. She said she did not have an anaphylactic reaction but had difficulty in breathing 2 days after having the first dose. She said she experienced 30 hours of labored breathing. She wanted to know if there is ""sulfa dioxide"" in the lipid/mRNA portion of the COVID-19 vaccine. She said she is highly allergic to ""sulfanized compounds"". She is also allergic to all forms of penicillins. Caller wanted to know if the second dose of the vaccine has the same ingredients as the first dose. She wanted to know if the ingredients have the same amounts as the first dose or if the actives are stronger. She based this question from ""most people having more reaction on the second dose of the vaccine"" and also from what Pfizer second line told her ""the first dose primes the system while the second dose strengthens the system"". She wanted to know what ingredient causes the anaphylactic reactions for this vaccine and if it is penicillin. On 22Jan2021 she learned that there is a small amount of Sulfa Dioxide in the lipid portion of mRNA and she is highly allergic to sulfa compounds. With her side effects she would also like to add that she had a severe case of shingles in 2007 that was not diagnosed until the end of the 7th week. She had seen 8 doctors, her family doctor, she had 3 ER visits so prior to the vaccine she had post herpetic neuralgia and so a week and half before the vaccine there were changes in temperature, the temperature and the weather going up and down so she was having mild shingles pain from the neuralgia going into the vaccine which was given on 22Jan2021. The other thing is she had high cholesterol and her cardiologist put her on a statin she does not have high BP but she has high cholesterol so she was started on a statin, it was Crestor 10 mg, actually it says it is Rosuvastatin Calcium 10 mg and she took that 18Jan2021 and the 19Jan2021 and then on the 20Jan2021 her doctor told her to stop it before her vaccine so she did and she felt okay just had mild reactions so she took the Rosuvastatin that Friday night 22Jan2021 and she took it 23Jan2021 then she took her self-off of it on 24Jan2021. She called her doctor on 25Jan2021 and he said yes stop the Rosuvastatin and stay off it until after your second dose of the vaccine. So she was having an allergic reaction in Jan2021 she has had a lot of side effects from being post shingles and all the side effects from COVID vaccine and being post shingles and the statin all of the possible side effects mirror one another. As far as the reaction she got a headache about 35 minutes after she took the shot Friday morning at about 9:35 AM and she took Tylenol twice that day, once that morning and she took it also around 4:30 PM when she was having medium pain at the injection site and that is when she took her statin and she woke up on 23Jan2021 and until late in the afternoon she had tightness in the chest so she took one more Tylenol then that was mid-morning, so total she had 3 doses of 325 mg Tylenol. Then on 24Jan2021 at about 4:30 AM in the morning she woke up with labored breathing, it wasn't normal. She did not have a closed throat but her breathing was labored, her chest felt tight there was a heaviness just like a feeling of discomfort. Then around 5 pm that same day the joint pain started in her right elbow, right thumb, right knee, left ankle and left instep and the pain wasn't constant it was jumping to different parts of her body and she still felt the tightness in her chest and heaviness all day. Then around 4PM on 24Jan2021, Saturday the labored breathing dissipated around 8pm and she did not take the statin that night then on 25Jan2021 her breathing was normal but she still had tightness in her chest. She had injection site pain on the 22Jan2021, 23Jan2021 and the 24Jan2021 and it was almost totally gone on 25Jan2021. Tiredness began on the evening 22Jan2021 the day she had the shot and it comes and goes. Headache- she had mild headache and she had took Tylenol so it was mitigated a little but it started 22Jan2021 and she had a headache through the 23Jan2021, 24Jan2021 and the 27Jan2021 so around 3:25PM yesterday she took another Tylenol yesterday 27Jan2021. Muscle pain she has had since 23Jan2021 and it has been ongoing but less today, she doesn't know if it will come back or not. It is mainly in the in the rhomboids which is the shoulder wings. She had it on both sides. Chills she had 25Jan2021, 26Jan2021 and 27Jan2021 and they come on mid-day-late afternoon they go on up until early evening, a little past supper/dinner time. Joint pain was 23Jan2021, 24Jan2021, 27Jan2021 and pain in her rhomboid muscles. She has had no fever, no swelling or redness at the injection site, no nausea. Feeling unwell- she would say from 23Jan2021 to the present she has not felt normal on 22Jan2021, it comes and goes She has not had swollen lymph nodes. Difficulty breathing 24Jan2021 at 4:30 am it woke her up and she had labored breathing, no closed throat and she stopped the Statin that day, tightness in her chest started 24Jan2021 in the morning and she had that 25Jan2021 26Jan2021 and it has been present on and off mainly in her back discomfort. She says the tightness is not really in the front around the heart but it is like a total tightness in the chest area. Muscle pain on the 27Jan2021 mainly in her back, the rhomboids. Fast heartbeat- She was sound sleep this morning at about 12:45AM and it woke her up her heartrate was 87, her BP was 135/81 (2021) and she did an ice pack for 16 minutes on her head and then she went back to sleep at 4:45 AM she woke up again her BP 131/87 pulse was 80 temp was 97.8 (2021). She didn't take her temp the first time she woke up she just did an ice pack for 16 minutes and she as up for a while typing side effects at that point. Then she went back to sleep from 6:20-7:20 and then when she woke up again her BP was 122/75 and pulse was 64, temp 98.3 (2021). For someone look at at her BP they may say that's not high but for someone post shingles, the pain, the nerve endings are already on edge she can feel it working on her body. They say reactions are proof that the vaccine is working but her issue with the joint pain, it disappeared when she stopped the Statin and then there is the labored breathing, she has had 2 new drugs that went into her system at the same time and she doesn't know, one has the documented side effects and the other one it is so unknown at least the mRNA part she does not know if she is just having a reaction to Sulfa. She says that blood pressure doesn't seem high but for someone whose body is stressed and with her pulse to go up when she is sound asleep, normally when her body is sleeping and she wakes up she would be about 117/70 (2021), she would have low numbers she doesn't have high BP. She took the statin for 2-3 days and then stopped it her doctor told her she could start and stop it and her doctor told her to stay off of it but she started it because she felt okay she only had a headache and injection pain so she said she is going to take it and then things intensified so she decided to stay off it. She has a history of having delayed serious side effects. She is allergic also to Penicillin and that is probably in the records already because she called and asked when she was thinking about taking it. It dates way back with her allergies with her, it is extensive Doxycycline, Ibuprofen, Levaquin, all forms of Penicillin, sulfanized antibiotics, Valium, latex, Omeprazole. She had shingles so bad after about 7.5 weeks of it going undiagnosed she had the 2 worse reaction and they asked her they went through her history and asked what are the 2 worst things she had and that was with Doxycycline they gave her that because they thought she had a bacterial infection and didn't realize it was shingles and she had a reaction to that she was sweating profusely and had very rapid heartrate and elevated BP she was unable to sleep literally she could feel the blood coursing through her veins. and then the other one she knows is Sulfa she has had that allergy since a child but she had rapid heart beat, sweating and there may have been other symptoms but she does not remember she was a child. She has been given Sulfa drugs since then and she is highly sensitive to Sulfa. Outcome of the event muscle pain was not recovered; injection site pain was recovered on 25Jan2021; labored breathing was recovered on 24Jan2021, while other events was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/01/2021,,UNK,ROSUVASTATIN,High cholesterol,Medical History/Concurrent Conditions: Allergic reaction to antibiotics; Latex allergy; Pain; Penicillin allergy; Post herpetic neuralgia; Sensitivity to weather change; Shingles (3 ER visits),,,"['Arthralgia', 'Blood pressure measurement', 'Body temperature', 'Chest discomfort', 'Chills', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Headache', 'Heart rate', 'Hypersensitivity', 'Malaise', 'Myalgia', 'Pain', 'Vaccination site pain']",UNK,PFIZER\BIONTECH,OT 1080161,NC,76.0,F,"pustules across her back; In her throat she is getting hoarse; itching with the rash; rash that is all over her body; splotches on her belly on her right side, right below her waist /Two splotches on right hand side; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249), via an unspecified route of administration at left upper arm on 26Jan2021 at 14:19 at SINGLE DOSE for COVID-19 immunisation. The patient had no previous immunizations. The patient had no prior vaccinations within 4 weeks and no additional vaccines administered on the same date. Medical history included allergic to penicillin, bladder infection, in the middle of her chest she had the pain cling through her back, and thyroid getting lazy and does not work. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), levothyroxine sodium (SYNTHROID) for thyroid getting lazy and does not work, vitamins, and sulfa drugs for bladder infection. It was reported that after getting the first dose of the vaccine the patient noticed she had pustules across her back on an unspecified date. The patient stated she ""got this rash from the tips of fingers, even the palm of my hands and it starts right under the neck and goes across my breast, on my belly, on my back and both arms and is now halfway down my shin bone."" On an unspecified date in Jan2021, she noticed this the afternoon of her vaccine around 7:00 when she saw two splotches on her stomach and it kept spreading. Sunday morning she went to Quick Care and yesterday went to her regular doctor. Her doctor gave her prednisone to take 10 mg 4 times a day, and hydroxyzine 10 mg for itching. In her throat she was getting hoarse on an unspecified date and was keeping a water bottle on her desk to keep hydrated. She stated she read on (website) that a rash can be a symptom of the vaccine. The caller asked, ""if the pustules burst will this cause anyone to get Covid 19? Is this a possible side effect of the vaccine? How long will this last? Is it okay to get my second shot with this reaction? Is there anything I should be taking to make it go away?"" It was further reported that patient received paperwork to call if there was any type of reaction. The patient mentioned she has a rash that was all over her body on 28Jan2021. It was on the top of her hands, in the palm of her hands, on her arms, back, under her breast, on her chest, on her stomach, on her bottom end, it was going down her legs and to her knees at this point. The patient initially stated she noticed the rash on Friday (29Jan2021), she later stated it was Thursday 28Jan2021 when the rash first started. She stated she first noticed splotches on her belly on her right side, right below her waist on an unspecified date in Jan2021. At first when looking at it she did not think too much about it. Later in the call she further clarified and stated it was possible she noticed these splotches the same day in the evening on the day she got the vaccine. She was not sure. If it was not the same day it was the next day. Friday (29Jan2021), she started to get as initially stated bumps, but later clarified rash under skin and it really proceeded from there. Additionally, it was reported that the rash continued to spread throughout her whole body. It was down to her shin now. Her whole upper body was horrible. She has some across her back. There are pustules on them like a pimple. It was like water in it ready to break. Sunday she went to a (clinic name) to get it looked at. She went Sunday 31Jan2021. She was given an intravenous (IV) and three needles were placed in it. She knows one was a steroid, she does not know what the other two were for, but she thinks one was probably for itching. The patient also confirmed she also experienced itching with the rash on 28Jan2021. It started the same day she noticed the rash. The patient stated it was like a full blown case now. The itching was with the rash on 28Jan2021. The itching and rash has continued to go down her body. It was on her buttocks now. It was hard to sit. It was in private up between her legs and stuff. Her body was almost 80 % full and covered with this stuff. She saw her regular doctor yesterday. The doctor at (clinic name) thought this reaction may have been an allergic reaction to a Sulfa drug she was taking for a bladder infection coincidentally at the same time, but she does not believe this was the case. Stated she had taken that sulfa drug before previously. She does not have the name of the drug to provide of the sulfa drug. She does not have it with her. No blood work was done. She was just looked at. They saw what was going on. The patient also mentioned she went on the internet to do research. She saw on Pfizer page three pictures that resembled what she had going on. It was also reported that the two splotches on right hand side started about 7'clock in the evening. At first did not think anything of it. Thought it was possibly a bug bite at first. Additionally, it was reported that patient went to see a doctor. She was already going to the doctor for a bone density scan and she showed the doctor what was going on at the same time. Her primary doctor thought this was due to the COVID 19 Vaccine. At end of call, patient questioned ""if the pustules across upper back and behind neck, will that cause anyone to get COVID 19? Side effect?"" The patient had no emergency visit. Therapeutic measures were taken as a result of itching with the rash, rash that is all over her body, and two splotches on right hand side. The patient had not yet recovered from rash that is all over her body while outcome of the events pustules, itching with the rash, in her throat she is getting hoarse, and ""splotches on her belly on her right side, right below her waist /Two splotches on right hand side"" was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/01/2021,,UNK,BABY ASPIRIN; SYNTHROID,,Medical History/Concurrent Conditions: Bladder infection; Chest pain; Penicillin allergy (Verbatim: Allergic to Penicillin); Thyroid disorder,,,"['Bone scan', 'Dysphonia', 'Pustule', 'Rash', 'Rash macular', 'Rash pruritic']",1,PFIZER\BIONTECH, 1080162,DE,60.0,F,"Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme weakness; rapid heartrate; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration in the left arm on 29Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy, coronary artery disease (CAD), hypertension (HTN), pulmonary hypertension, sick sinus syndrome, hypothyroidism, hyperlipidemia, osteoporosis, chronic kidney disease (CKD), and diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included alprazolam (XANAX), venlafaxine hydrochloride (EFFEXOR), quetiapine fumarate (SEROQUEL), sertraline hydrochloride (ZOLOFT), isosorbide mononitrate (IMDUR), and metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 02:15, the patient experienced extreme soreness in left upper arm, chills, headache, tiredness, feeling like she had the flu, extreme weakness, and rapid heartrate. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/30/2021,1.0,SEN,XANAX; EFFEXOR; SEROQUEL; ZOLOFT; IMDUR; METOPROLOL,,Medical History/Concurrent Conditions: Chronic kidney disease; Coronary artery disease; COVID-19; Hyperlipidemia; Hypertension; Hypothyroidism; Osteoporosis; Penicillin allergy; Pulmonary hypertension; Sick sinus syndrome,,,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Heart rate', 'Heart rate increased', 'Influenza like illness', 'Pain in extremity']",1,PFIZER\BIONTECH, 1080163,IN,75.0,F,"Blood pressure high; Blood sugar usually is between 115-130 and now last night it has been 168 and higher.; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231) via an unspecified route of administration in left arm on 21Jan2021 10:30 at single dose for COVID-19 immunisation, amlodipine besilate (manufacturer unknown) oral from an unspecified date and ongoing at 10 mg twice a day for high blood pressure, insulin human (NOVOLIN R) via an unspecified route of administration from an unspecified date and ongoing as needed (U-100, inject 5 units by sliding scale if blood sugar over 150) for diabetes, clonidine oral from an unspecified date and ongoing at 0.2mg daily, via an unspecified route of administration from an unspecified date to an unspecified date at 0.3 mg daily for high blood pressure, hydrazine oral from an unspecified date and ongoing at 200 mg two times a day (2 tablets by mouth in the morning, 2 tablets by mouth in the evening) for high blood pressure. Medical history included ongoing thyroid nodule and her thyroid was okay and her numbers okay for cholesterol, ongoing dialysis, high blood pressure. The patient's concomitant medications were not reported. Since taking the vaccine, the past 4-5 days the patient's blood pressure and blood sugar had been out of whack. The patient had said something to her doctors about this because something was going on because she has been having to use her sliding scale insulin when her sugar got to 150. Usually was under 150 and if she went over that she took a shot of insulin if necessary. She had used insulin human more in the past few days at least once a day. The patient had not had to use insulin human in past, it was still almost full. Again, the patient had taken more shots since this Covid than she had had in a whole year. The patient just talked to the kidney doctor and then she was going to the Endocrinologist on Thursday for the first time. They maintain her blood sugar records at dialysis center. Blood sugar usually was between 115-130 and now last night it had been 168 and higher. The patient knew something was not right and it had not been like that for so long. The patient spoke with the dialysis doctor on 01Feb2021 about her blood pressure and they adjusted her medication. The patient clarified her blood pressure had also been high. When she left 01Feb2021 her blood pressure was 168/79 and later that day was 189/70 which was very unusual for her. The other day when she went home it was 136/78. It was the Clonidine that was adjusted was taking 0.1mg, 2 tablets a day to now taking 3 a day. The action taken in response to the events for amlodipine besilate, insulin human, clonidine, hydrazine was dose not changed. The outcome of events was not recovered. Pfizer is a marketing authorization holder of [Amlodipine Besilate] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Amlodipine Besilate] has submitted the same report to the regulatory authorities.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/01/2021,,OTH,Amlodipine Besylate; clonidine; hydrazine; NOVOLIN R,Dialysis (Verbatim: Dialysis); Thyroid nodule (Verbatim: Thyroid nodule),Medical History/Concurrent Conditions: Blood pressure high,,,"['Blood cholesterol', 'Blood glucose increased', 'Blood pressure measurement', 'Glycosylated haemoglobin', 'Hypertension', 'Thyroid function test']",UNK,PFIZER\BIONTECH, 1080164,,,M,"Fallen; an injury to his arm / hurt his arm; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's wife reported that she and her husband (patient) was due for their second Covid19 vaccine tomorrow (03Feb2021). However, her husband received a tetanus shot last Friday, 29Jan2021, after an injury to his arm. He had fallen and hurt his arm on an unknown date and needed one. She was asking about the dosing interval between vaccines. Outcome of the events was unknown. Information about lot/batch number is requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Fall', 'Limb injury']",1,PFIZER\BIONTECH, 1080165,,,M,"he was hospitalized because ripped something in his esophagus; started coughing blood; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number no reported, via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. Patient reported that he received the 2nd dose of the Pfizer COVID-19 vaccine last 27Jan2021. On Friday 29Jan2021, he was hospitalized because ripped something in his esophagus and started coughing blood. He knows that this is not related to the vaccine but is trying to find out any effects of his prescribed medications with the efficacy of the vaccine. He was prescribed methylprednisolone and Z-pak (Azithromycin) 4mg. He's heard that methylprednisolone can lower the efficacy of the vaccine. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: The reported events ripped something in his esophagus and coughing blood were likely due to diet, and unrelated to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).",Not Reported,,Not Reported,Yes,,Not Reported,U,01/27/2021,,,UNK,,,,,,"['Haemoptysis', 'Oesophageal rupture']",2,PFIZER\BIONTECH, 1080166,NY,46.0,M,"itchy, sensitive at site of injection; sensitive at site of injection; Size of half a raisin -slightly raised and slightly swollen; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient (also the age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available at the time of the report), via an unspecified route of administration at the left arm (reported as left shoulder) on 31Jan2021 at SINGLE DOSE for covid-19 immunization. The patient had no allergies to medications, food, or other products and no other medical history. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19, since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included finasteride (reported as Generic form for Propecia: other medications the patient received within 2 weeks of vaccination). It was reported that itchy, sensitive at site of injection - started 24H after (reported onset on 01Feb2021) and still sensitive 48H after. Size of half a raisin -slightly raised and slightly swollen. Case/ events were considered non-serious. The outcome of the events was not recovered. No treatment was received. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/31/2021,02/01/2021,1.0,UNK,FINASTERIDE,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Vaccination site discomfort', 'Vaccination site pruritus', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 1080167,IL,77.0,F,"She can breathe better moving around but when she sits down, her breathing seems to be congested; Nose started stuffing up again; Her nose just swells; congestion in her chest; her arm was sore/ Little pain in her right leg; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) solution for injection, intramuscular on right arm on 01Feb2021 at 09:10 AM at single dose for COVID-19 immunization. Medical history included breathing problems and COVID-19 on 31Oct2020 in which she waited exactly 90 days to get the vaccine. The patient had a small touch of pneumonia on her lower lobe of her right lung, she was on a lot of antibiotics and a strong herbal solution. She was on one antibiotic for 5 days and another for 7 days. She was on the herbal stuff for 7 days. She took all that stuff and was drinking lemon juice and hot water and breathing in lemon scent and Vicks Salve all in her nose. She also was prescribed an asthma pump. She had all that stuff going into her system. She also was tested, and she has H. Pylori bacteria. She explained her whole family must have that, it's hereditary. That wasn't her issue. However, all that she put in her stomach and in her system caused her to have stomach issues. She told the doctor that antibiotics made her sick. She told the person administering the vaccine that antibiotics made her sick and she was told it didn't matter and that this wouldn't interfere with the COVID-19 vaccine. Her stomach was all messed from all that stuff. The patient also has anxiety. She has never been treated with anxiety. She has had anxiety since she was a very young women and she has never been treated for it. When probed for any product information she had available for the medications that messed her stomach up and made her sick she provided the following information: The first medication she took was azithromycin (Z-PAK, lot number: KG0706, expiration date: Nov2021, NDC number: 0781-8089-26) that was dispensed in a little box. Dose was 250 mg which she took daily doses for 5 days. One of the doctors gave her a levofloxacin 50 mg for 7 days. She was given the pump, salbutamol (ALBUTEROL SULFATE HFA INHALATION AEROSOL, lot number: 102B4, expiration data: 20Jan2022) 90mcg per actuation. She explained she only took this once. She was so scared from this stuff. It squirted down her mouth. Another doctor prescribed her omeprazole 40 mg capsule every day because she told him her stomach was messed up. The patient was prescribed amoxicillin 500 mg tablet, take one tablet, by mouth three times daily for 14 days and clarithromycin 500 mg tablet, take one tablet by mouth twice daily for 14 days. The new doctor also had her taking omeprazole (the doctor wrote another prescription for this). However, this time the dose was 20 mg and she was prescribed to take that twice daily for 14 days. She didn't finish this medication. She told the doctor that antibiotics made her sick and the doctor explained because of her bacteria, she ordered the antibiotics to make her feel better. The patient told the doctor if she could live like this, let her not take these medications until she gets her stomach better and she would eat healthy food and find natural antibiotics at the health food store. She mentioned using oregano. She took that once a day. When she knew she was getting ready to take the COVID-19 vaccine, she stopped taking that 2 weeks before taking the vaccine. She stopped taking cholesterol medicine at night 2 weeks ago, it was making her sick to her stomach. She stopped her potassium medicine. She didn't want any of the medicines interfering with the vaccine. The patient also took an herbal medicine that was called a Spiritual, Mental, Emotional, Elevation Science of Eternal Life. It's a detox mixture that was very strong. She took this for 7 days. She had lost weight because she was not eating. The patient has always been a junk food eater. She quit eating junk food and that probably also had something to do with her being sick. She cooks all her food. There was no additional vaccine administered on the same date with COVID-vaccine. The patient has no prior vaccinations within 4 weeks. She has never had a flu vaccine, pneumonia vaccine or shingles vaccine. This was her very first vaccine. Concomitant medication was reported as none. The patient didn't know if it was anything serious, but she tried to read all the information that was given to her. She was looking at the information and she saw ""if you have any difficulty breathing"". That was the only one that she was having. She could breathe better moving around but when she sits down, her breathing seems to be congested. She was calling to see if this was anything serious and if she needed to go the emergency room. Since her breathing has been acting funny, she has been trying to keep moving around. She was cleaning her bathroom and the Bleach Cleaner and other cleaner opened her nose. She was listening to a town hall meeting and when she sat down to listen to it, her nose started stuffing up again. She has just been trying to get up and move around. Since she has been talking on the phone, her breathing was a little better. Her nose just swells. She got up and was beginning to eat breakfast when all of a sudden, the difficulty breathing started happening. It was around 8:45 am this morning (02Feb2021). It has improved, but when she would sit down, it would tighten up and she would have congestion in her chest. Since she has been moving around talking, it has gotten better. Sitting down has something to do with the difficulty breathing. She has had breathing problems before. The patient received the COVID-19 vaccine yesterday, 01Feb2021. She sat for half an hour afterwards and then came home. She then slept all night and stated her arm was sore on Feb2021, but it was feeling better. She also had a little pain in her right leg on the side she received her vaccine on Feb2021, which was currently gone. She wasn't sure if the breathing problems were from the vaccine or something else. The patient did not go to the emergency room or visited his physician in response to the events. She mentioned that if this continues, she probably will go to urgent care. The outcome of the event dyspnea at rest and respiratory tract congestion was recovering, recovered on Feb2021 for pain in extremity, and unknown for all other events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,UNK,,,"Medical History/Concurrent Conditions: Anxiety; Bacterial infection due to helicobacter pylori (H. pylori) (She explains her whole family must have that, its hereditary.); Breathing difficult; COVID-19; Gastric disorder; Lost weight; Pneumonia",,,"['Dyspnoea at rest', 'Investigation', 'Nasal congestion', 'Nasal oedema', 'Pain in extremity', 'Respiratory tract congestion', 'Weight']",1,PFIZER\BIONTECH,OT 1080168,WI,64.0,F,"Muscle soreness of bilateral legs and hip joints/ got worse; pelvic pain; Couldn't walk; Drag showed inflamed pelvic girdle; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. Solution for injection, lot number: 42 (as reported)), via an unspecified route of administration on the right arm on 15Jan2021 08:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included metoprolol, fish oil, calcium and monascus purpureus (RED YEAST RICE). The patient had known allergies: DILAUDID. The patient experienced muscle soreness of bilateral legs and hip joints on 22Jan2021 and it got worse. Patient also experienced deep pelvic pain on an unspecified date in Jan2021 and went to physician on 24Jan2021. The patient couldn't walk in Jan2021. Cat scan showed no apparent reason, drag showed inflamed pelvic girdle on Jan2021. The outcome of the events was not recovered.; Sender's Comments: Case serious due to Pelvic inflammatory disease, classified Medically Significant and always serious event, per List Critical Term. Other reported events were non-serious. Based on available information, the Company considered that all reported events were possibly associated to BNT162B2 injection, due to a plausible chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/01/2021,,PVT,METOPROLOL; FISH OIL; CALCIUM; RED YEAST RICE,,,,,"['Computerised tomogram', 'Gait disturbance', 'Myalgia', 'Pelvic inflammatory disease', 'Pelvic pain']",1,PFIZER\BIONTECH, 1080169,IL,80.0,F,"Thumping in ears; swelling in face; straight mouth unable to move; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 29Jan2021 09:00 at a single dose for COVID-19 immunisation. The patient has no medical history. Concomitant medication included acetylsalicylic acid (ASPIRIN BAYER) and vitamin D [vitamin D nos]. The patient experienced thumping in ears while in observation room and had swelling in face with a straight mouth unable to move on 30Jan2021 23:30. Outcome of events was unknown. The adverse events resulted in emergency room/department or urgent care. No treatment was given for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/30/2021,1.0,PVT,ASPIRIN BAYER; VITAMIN D [VITAMIN D NOS],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE,,,"['Dyskinesia', 'Swelling face', 'Tinnitus']",1,PFIZER\BIONTECH, 1080170,NV,45.0,F,"arm hurt worse than ever; extremely exhausted; headache; controllable chills; fever of 101; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 02Feb2021 10:30, at single dose, for COVID-19 immunization, at a school or student health clinic. Medical history included COVID-19 (prior to vaccination) and arm hurt, both on an unknown date. The patient was not pregnant at the time of vaccination and has no allergy to medications, food, or other products. Concomitant medication included ibuprofen and vitamins. It was reported that on 02Feb2021 at 14:30, about 4 hours after getting the vaccine, the patient's arm hurt worse than ever and she was extremely exhausted. On 02Feb2021, in the middle of the night, the patient experienced headache, controllable chills and had a fever of 101. No treatment was given for the events. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was not resolved. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,SCH,IBUPROFEN; VITAMINS NOS,,Medical History/Concurrent Conditions: COVID-19 (prior to vaccination); Pain in arm,,,"['Body temperature', 'Chills', 'Fatigue', 'Headache', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH, 1080171,DE,48.0,F,"fatigue; warming feeling; sore arm; joints sore; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: el3248 and expiry date: unknown), via an unspecified route of administration on the left arm, on 02Feb2021 11:00 at a single dose for COVID-19 immunization. The first dose was received on 12Jan2021 11:00 on the right arm (lot number: ej1656). Medical history included cancer. Patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and no other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue, warming feeling, sore arm, joints sore on 02Feb2021 15:00. No treatment was received for the events. Outcome of the events was not recovered. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination. Covid test was on 03Feb2021 with unknown results. The reporter considered the events non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,WRK,SYNTHROID,,Medical History/Concurrent Conditions: Cancer,,,"['Arthralgia', 'Fatigue', 'Feeling hot', 'Pain in extremity', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1080172,FL,35.0,F,"Swelling in soft pallet and oral mucosal membranes; Swelling in soft pallet and oral mucosal membranes; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318) on right arm, via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS), tachycardia, epilepsy, allergies to penicillin, cherry and apple. The patient was not pregnant at the time of vaccination. Concomitant medications included spironolactone (ALDACTONE), celecoxib (CELEXA) and naproxen sodium (ALEVE). The patient experienced swelling in soft pallet and oral mucosal membranes on 02Feb2021. She took 2 doses of 25 mg diphenhydramine hcl (BENADRYL). One at onset and one at recurrence a few hours later. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. Therapeutic measures were taken as a result of swelling in soft pallet and oral mucosal membranes which included self-administered diphenhydramine hcl. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,WRK,ALDACTONE; CELEXA; ALEVE,,Medical History/Concurrent Conditions: Epilepsy; Fruit allergy; Penicillin allergy; Polycystic ovarian syndrome; Tachycardia,,,"['Mouth swelling', 'Palatal swelling']",1,PFIZER\BIONTECH, 1080173,KS,29.0,F,"headache; 9.5hrs after 2nd vaccine dose a fever set in and climbed to 101.2/fever; chills; muscle aches; nausea; This is a spontaneous report from a contactable Other Health Professional reported for herself (patient). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302; expiration date not provided), intramuscular (left arm) on 02Feb2021 13:30 at SINGLE DOSE for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Patient is not pregnant. The patient has no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140; expiration date not provided), intramuscular (left arm) on 13Jan2021 for COVID-19 immunisation. The patient experienced headache, '9.5hrs after the 2nd vaccine dose a fever set in', chills, muscle aches, and nausea all on 02Feb2021 at 23:00. Patient's clinical course is as follows: 9.5hrs after 2nd vaccine dose a fever set in and climbed to 101.2. To accompany the fever were chills, muscle aches, nausea, and a headache. After taking a fever reducer, the nausea stayed and the fever returned approximately 8hrs as did the chills, muscle aches, and headache. It was reported that patient took a fever reducer again and now waiting to see if that helps again. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included body temperature with result of '101.2 (9.5hrs after 2nd vaccine dose a fever set in, and climbed to 101.2)' on 02Feb2021. The patient has not received treatment for headache, chills, muscle aches, and nausea. Facility where the most recent COVID-19 vaccine was administered was reported as 'Workplace clinic'. Outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,WRK,,,,,,"['Body temperature', 'Chills', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",2,PFIZER\BIONTECH,OT 1080174,MI,23.0,F,"muscle pain in arm and back; Soreness/Tenderness in arm as expected; Headache; fever; chills; This is a spontaneous report from a contactable consumer (patient herself). A 23-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3248), via an unspecified route of administration on the left arm, on 02Feb2021 08:15 at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 20:00, the patient experienced soreness/tenderness in arm as expected. At around 8pm (12 hours after injection), patient started feeling muscle pain in arm and back. About an hour later, patient started to run a fever and had chills. Headache came on after and lasted through the night and into the next morning. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on an unspecified date. Case was reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,UNK,,,,,,"['Chills', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1080175,MI,,F,"Body aches; Muscle pain; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 21Jan2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced body aches on an unspecified date, muscle pain on an unspecified date. Patient took one 650mg extra strength tylenol 12 hours later due to body aches and muscle pain. The outcome was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,,,UNK,,,,,,"['Myalgia', 'Pain']",1,PFIZER\BIONTECH, 1080176,MI,58.0,F,"felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Similar to a migraine; tired; slept for a long time; light and sound was very painful; light and sound was very painful; This is a spontaneous report from a contactable consumer (reported for herself). A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration from 28Jan2021 10:00 at a single dose in the right arm for COVID-19 immunization. Medical history included chronic sinus infections. Patient was not pregnant at the time of vaccination and the report. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included trazodone, xylometazoline hydrochloride (SUDAFED), cetirizine hydrochloride (ZYRTEC), and fluticasone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took clarithromycin (BIAXIN) and experienced allergies (reported as know allergies). About an hour after the injection, on 28Jan2021 11:00 AM, patient felt lightheaded, had a low grade fever, chills and sweating, light and sound was very painful - similar to a migraine even though patient have never had one previously, and patient was very tired and slept for a long time. These lasted for 5 days. The events required doctor or other healthcare professional office/clinic visit in response to the events. Patient received treatment for the adverse events and was reported as unknown. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events reported was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,UNK,TRAZODONE; SUDAFED; ZYRTEC; FLUTICASONE,,Medical History/Concurrent Conditions: Chronic sinusitis (Chronic sinus infections),,,"['Body temperature', 'Chills', 'Dizziness', 'Fatigue', 'Hyperacusis', 'Hyperhidrosis', 'Hypersomnia', 'Migraine', 'Photophobia', 'Pyrexia']",1,PFIZER\BIONTECH, 1080177,AZ,69.0,M,"Fever; Muscle aches; Low back and hip pain; Low back and hip pain; Severe headache; This is a spontaneous report from a contactable consumer reported for himself. A 69-year-old male patient received the first dose of BNT162B2 (lot number: EL 9264), via an unspecified route of administration in the left arm on 02Feb2021 07:00 (at the age of 69-years-old) at single dose for COVID-19 immunization. Medical history included COVID-19 on 23Nov2020, heart bypass, high cholesterol and triglyceride. Concomitant medication included clopidogrel bisulfate (PLAVIX), lisinopril, metoprolol, fenofibrate and atorvastatin calcium (ATORVAST). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 03Feb2021 at 12:00 AM, the patient experienced fever, muscle aches, low back and hip pain and severe headache. He stated that its like he has COVID all over again. The outcome of the events was not recovered. It was unknown if the patient received treatment for the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/03/2021,1.0,UNK,PLAVIX; LISINOPRIL; METOPROLOL; FENOFIBRATE; ATORVAST,,Medical History/Concurrent Conditions: Coronary bypass (Heart bypass); COVID-19; High cholesterol; Triglycerides high (High Triglyceride),,,"['Arthralgia', 'Back pain', 'Headache', 'Myalgia', 'Pyrexia']",1,PFIZER\BIONTECH, 1080178,GA,41.0,F,"Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; sweating profusely; very low body temp; rapid pulse; shaking; This is a spontaneous report from a contactable consumer who reported for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 02Feb2021 04:00 PM at a single dose for covid-19 immunisation. Medical history included obesity. Patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 02Feb2021 at 10:00 PM (6 hours after vaccine was given), the patient experienced severe stomach cramping, diarrhea, dizzy, nausea, cold clammy pale skin, sweating profusely, very low body temp, rapid pulse, and shaking. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/02/2021,0.0,PUB,,,Medical History/Concurrent Conditions: Obesity,,,"['Abdominal pain upper', 'Body temperature', 'Body temperature decreased', 'Cold sweat', 'Diarrhoea', 'Dizziness', 'Heart rate', 'Heart rate increased', 'Hyperhidrosis', 'Nausea', 'Pallor', 'Tremor']",1,PFIZER\BIONTECH, 1080179,NY,38.0,F,"My skin started to become itch with red spots; My skin started to become itch with red spots; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number and expiry date unknown), via an unspecified route of administration at the left arm on 13Jan2021 09:15 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient reported that her skin started to become itch with red spots on 30Jan2021 14:00. No treatment was received for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included nasal swab: negative on 27Jan2021. The outcome of the events were recovering. Events were reported as non-serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/30/2021,17.0,UNK,,,,,,"['Pruritus', 'Rash macular', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1080180,CO,35.0,F,"abdominal pain- feels like pulled muscles/like I got kicked in the stomach; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) solution for injection at the age of 35-years-old, via an unspecified route of administration on 27Jan2021 at 1:15 PM at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications were reported as none. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. She did not receive any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was unknown. The patient experienced abdominal pain which felt like she pulled a muscle, like she got kicked in the stomach on 02Feb2021 at 3:00 PM. The patient did not receive any treatment in response to the event. The outcome of the event was not recovered. The event was assessed as non-serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/02/2021,6.0,UNK,,,,,,['Abdominal pain'],UNK,PFIZER\BIONTECH, 1080181,WV,53.0,M,"Severe chills; entire body muscle aches; mild nausea; extreme fatigue; mild cough; severe headache; Slight fever; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 13:00, at single dose, for COVID-19 immunization, at a public health department. Medical history included dermatomyositis (autoimmune disorder). The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included mycophenolate mofetil (MYCOPHENOLATE). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: unknown) received at 53 years of age, via an unspecified route of administration on the left arm, on 29Dec2020 09:00, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 28Jan2021 at 10:00, the patient experienced severe chills, entire body muscle aches, mild nausea, extreme fatigue, mild cough, severe headache, all lasting several days; and slight fever which lasted for 1 day. The adverse events resulted to physician office visit. The patient underwent lab tests and procedures which included rapid test (nasal swab) on 31Jan2021 with negative result and nasal swab on 01Feb2021 with unknown result (pending). The patient recovered from slight fever on 29Jan2021a at 10:00; and was recovering from severe chills, entire body muscle aches, mild nausea, extreme fatigue, mild cough and severe headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/28/2021,7.0,PUB,MYCOPHENOLATE,,Medical History/Concurrent Conditions: Dermatomyositis,,,"['Body temperature', 'Chills', 'Cough', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1080182,LA,77.0,F,Nervous Anxiety; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported PFIZER BIONTECH COVID-19 VACCINE; lot number: EL9265; expiration date: unknown) at vaccination age of 77-year-old via an unspecified route of administration in the left arm on 27Jan2021 13:30 at a single dose for covid-19 immunization. The patient's medical history concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior vaccination. The patient previously took naproxen (ALEVE) but had allergies to Aleve. The patient reported that she had nervous anxiety for second day (28Jan2021). The event did not receive treatment. The patient has not been tested for COVID-19 since vaccination. The outcome of the event was not recovered.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/28/2021,1.0,PVT,,,,,,['Anxiety'],1,PFIZER\BIONTECH, 1080183,CA,79.0,F,"Quivering muscle pain when attempting to stand and to sit; Thigh muscles still feel quivering and tight/tight and unstudy; This is a spontaneous report from a contactable consumer (patient). A 79 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number:EL9262), via an unspecified route of administration (on left arm) on 29Jan2021 (at the age of 79 -years-old), single dose for COVID-19 immunization. Medical history included Mech. Valve/ Arthritis from an unknown date. Concomitant medication included warfarin, bempedoic acid, hydrochlorothiazide, losartan potassium. The patient previously took ciprofloxacin and experienced drug allergy. The patient experienced quivering muscle pain when attempting to stand and to sit. Occurring upper thighs in front and under buttocks in rear. Similar feeling across groin area when sitting. Began the 2nd day after vaccine shot on a Sunday. Now, on Wednesday still occurring . however, not as pronounce. I still push myself up from sitting as well as sitting down as thigh muscles still feel quivering and tight and unstudy. No treatment for the adverse events. The outcome of the events was recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were assessed as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/31/2021,2.0,PVT,WARFARIN; BEMPEDOIC ACID; LOSARTAN/HYDROCHLOORTHIAZIDE,,Medical History/Concurrent Conditions: Arthritis (Mech. Valve/ Arthritis),,,"['Muscle tightness', 'Myalgia']",1,PFIZER\BIONTECH, 1080184,MA,40.0,F,"chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL9264), via an unspecified route of administration in the left arm on 30Jan2021 15:45 at a single dose for covid-19 immunization. Medical history included heart problems, migraine, anemia, asthma and unspecified allergies. The patient is not pregnant. The patient's concomitant medications were not reported. On 30Jan2021 19:00, the patient experienced chest pain, loss of smell, fever, headaches, vomiting and nausea. The patient did not receive treatment for the events. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,PHM,,,Medical History/Concurrent Conditions: Allergy (known allergies: Yes); Anemia; Asthma; Heart disorder; Migraine,,,"['Anosmia', 'Chest pain', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH, 1080185,CA,35.0,F,"Severe right leg (thigh knee and calf) pain 7 days after vaccine; Severe right leg (thigh knee and calf) pain 7 days after vaccine; Severe back muscle spasm 1 day after injection; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL1284), via an unspecified route of administration on left arm on 29Dec2020 at 11:30 (at the age of 35years) at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included allergies: Sulfa. The patient's concomitant medications were not reported. The patient experienced severe back muscle spasm 1 day after injection (30Dec2020). Severe right leg (thigh knee and calf) pain 7 days after vaccine (05Jan2021). There were no treatment given for the events. The events were considered non-serious by the patient as did not results in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and no congenital anomaly/birth defect. The adverse events result in doctor or other healthcare professional office/clinic visit. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The COVID-19 test (nasal swab) on 12Jan2021 was negative. The outcome of the events was recovered for pain in extremity and arthralgia in 2021 and for muscle spasms on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/30/2020,1.0,PVT,,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,"['Arthralgia', 'Muscle spasms', 'Pain in extremity', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1080186,,,F,"she got a cold; This is a spontaneous report from a non-contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2, also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient informed that she had an appointment to receive her second dose of the vaccine tomorrow, but her HCP advised to wait since she got a cold. The outcome of event was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Nasopharyngitis'],1,PFIZER\BIONTECH, 1080187,NY,73.0,M,"diarrhea; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Feb2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The consumer's father received the first dose of Pfizer's vaccine yesterday (02Feb2021). He had diarrhea since last night (02Feb2021). The consumer asked if it was due to the vaccine and how long it will last. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/02/2021,0.0,UNK,,,,,,['Diarrhoea'],1,PFIZER\BIONTECH, 1080188,CA,54.0,F,"Nausea; sore arm; fever; This is a spontaneous report from a contactable healthcare professional. A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 3246), via an unspecified route of administration on the right arm on 02Feb2021 08:15 at single dose for COVID-19 immunisation. Medical history allergies: pcn, latex, wheat/gluten, dairy, soy, corn. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (lot number: EL 3246) on 11Jan2021 06:30 PM on the right arm for covid-19 immunisation; epinephrine and experienced allergies. At 6:00 PM on 02Feb2021, patient developed fever 99.4 and steadily rose to 101.5 by 9:30 PM; sore arm all day and night, following day much less sore and easier to move. Fever stayed overnight, down to 100.5 morning on 03Feb2021. Nausea accompanied fever and still have slight nausea. The patient received no treatment. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Dairy intolerance; Food allergy; Gluten sensitivity; Latex allergy; Penicillin allergy,,,"['Body temperature', 'Nausea', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH, 1080189,VA,76.0,F,"only sore arm; feeling tired; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (reporting for herself). A 76-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration (at the age of 76) single dose on 02Feb2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced only sore arm and feeling tired both on an unspecified date. She has had to take a nap everyday since. The outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,,,UNK,,,,,,"['Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH, 1080190,,,M,"light headedness to the point of feeling like passing out; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (Age: 71; Unit: Unknown; as reported) received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 03Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced: light headedness to the point of feeling like passing out (non-serious) in Feb2021. The clinical course was reported as follows: The patient reported that during the 15 minutes after receiving the injection, he was fine. Thirty minutes post vaccination, while driving home, the patient experienced light headedness to the point of feeling like passing out. The patient had to pull over on the highway. The feeling lasted about an hour before subsiding. The patient stated that after an hour and a half after receiving the injection, the light headedness was mostly gone. The clinical outcome of the event was recovering. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/01/2021,,UNK,,,,,,['Dizziness'],1,PFIZER\BIONTECH, 1080191,,,F,"ear pain; allergic sinusitis; This is a spontaneous report from a Pfizer Sponsored Program . A non-contactable consumer reported that a 34-year-old female patient received her second dose of bnt162b2 (BNT162B2 also reported as Pfizer-Biontech covid-19 vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 02Feb2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced ear pain and allergic sinusitis on an unspecified date. She already took Tylenol as treatment. The outcome of event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,,,UNK,,,,,,"['Allergic sinusitis', 'Ear pain']",2,PFIZER\BIONTECH, 1080192,MO,68.0,M,"Fever worsened; arm soreness/achy legs; minor aches and pains; Chills; slight/mild headache; fever of 100 Fahrenheit then 101.6 Fahrenheit; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3248), via an unspecified route of administration on 02Feb2021 at 09:45 at 68-years-old at a single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken for type 2 diabetes mellitus from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: arm soreness/achy legs (non-serious) on 02Feb2021 with outcome of recovering, minor aches and pains (non-serious) on 02Feb2021 with outcome of recovering, chills (non-serious) on 02Feb2021 with outcome of recovered on 03Feb2021, slight/mild headache (non-serious) on 02Feb2021 with outcome of recovered on an unspecified date, fever of 100 Fahrenheit then 101.6 Fahrenheit (non-serious) on 02Feb2021 (as reported) with outcome of not recovered, fever worsened (non-serious) on an unspecified date with outcome of unknown. The clinical course was reported as follows: The patient reported having aches, pains, chills, a slight headache, and a fever of 100 Fahrenheit in the afternoon and evening on 02Feb2021 (as reported). On the morning of 03Feb2021, the patient reported having a fever of 101.6 Fahrenheit (as reported). The patient also reported a fever of 99.1-99.4 Fahrenheit (the night before the report); then, the next morning had a fever at 100 Fahrenheit and then 101.6 (as reported).The patient further reported that he had arm soreness, upon which the patient put a cold towel on it, and it was a lot better on 03Feb2021. The patient also had a mild headache and took paracetamol (TYLENOL). The patient was concerned about the fever. The patient read to drink liquids and dress lightly; and had been drinking plenty of liquids. The patient reported that his weight was 190-200 lbs. The had minor aches and pains, and he was a little achy in his legs which started on 02Feb2021 as well. At the time of the report, it was about the same. It was worse in the morning but was better now. Then the patient had a small chill the day before and at the time of the report. The patient he turned up the heat, and it went away. The was scheduled for his second dose on 23Feb2021. The doctor recommended the patient to get the vaccine because of his age and having type 2 diabetes. The patient had his diabetes under control with metformin. The patient underwent lab tests and procedures which included body temperature: 99.1 Fahrenheit on 02Feb2021, body temperature: 99.4 Fahrenheit on 02Feb2021, body temperature: 100 Fahrenheit on 02Feb2021, body temperature: 101.6 Fahrenheit on 03Feb2021. Therapeutic measures were taken as a result of arm soreness/achy legs and slight/mild headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,PVT,METFORMIN,,Medical History/Concurrent Conditions: Type 2 diabetes mellitus,,,"['Body temperature', 'Chills', 'Condition aggravated', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",1,PFIZER\BIONTECH, 1080193,MI,51.0,F,"Fever; aches and pains; headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received second dose of BNT162B2 (brand=Pfizer), via an unspecified route of administration (right arm) on 02Feb2021 08:30 at a single dose for COVID-19 immunization at a workplace clinic. Medical history included allergies to macadamia nuts. There were no concomitant medications. No other medications the patient received within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (brand=Pfizer) on 14Jan2021 07:30 AM (vaccine location= left arm). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced fever, aches and pains, headache on 03Feb2021 05:00 AM. No treatment received for the events. The events were reported as non-serious (did not result to death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, and not congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/03/2021,1.0,WRK,,,Medical History/Concurrent Conditions: Allergy to nuts,,,"['Headache', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1080194,NM,55.0,F,"white blood cell count was down to 2.3/absolute neutrophils were low/neutropenia; body ache; sore throat; chills; I've haven't had this shift before in lymphocyte; This is a spontaneous report from a contactable healthcare professional. A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunisation. Medical history included MS and saw neurologist in Nov2020, prior to getting the vaccine and at that time did not have the typical blood work drawn which would have been a CBC and CMP and white blood cell could usually runs in the 3.5-3.7. Concomitant medication included dimethyl fumarate (TECFIDERA). The patient previously took TYSABRI and had to be taken off of that in 2010 due to evidence by CBC of bone marrow suppression. The patient had IVIG and experienced myelosuppression. Patient participated in clinical trials with rituximab and took VIOXX before it was removed from the market. The patient really loved VIOXX and used to prescribe it to her patients; first dose of BNT162B2 on 17Dec2020 for COVID-19 immunisation. A week after the patient got the vaccine, she had a sore throat, chills and body aches. The patient just went to bed early and was fine. The patient reported those symptoms through the CDC VAERS site. The patient had blood work drawn on 29Jan2021 and was shocked that the white blood cell count was down to 2.3 and absolute neutrophils were low. The patient was referred to follow up with a hematologist for the neutropenia. The patient thinks this is not related to the Covid vaccine. The patient haven't had this shift before in lymphocyte and neutrophil count. On 29Jan2021, CBC and CMP and that is comprehensive metabolic panel, complete blood count and lipid panel. The patient received no treatment. The outcome of white blood cell count was down to 2.3/absolute neutrophils were low/neutropenia was not recovered and other events was unknown.; Sender's Comments: Based on the information available a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/02/2021,01/01/2021,,UNK,TECFIDERA,,Medical History/Concurrent Conditions: MS; White blood cell decreased,,,"['Chills', 'Full blood count', 'Lipids', 'Lymphocyte count', 'Lymphocyte count abnormal', 'Metabolic function test', 'Neutropenia', 'Neutrophil count', 'Oropharyngeal pain', 'Pain', 'White blood cell count']",2,PFIZER\BIONTECH, 1080195,,,U,"has had itching; cold chills; tenderness; bad headache; some diarrhea; cold sweats; some swelling of the arm; This is a spontaneous report from a contactable consumer, the patient. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown date (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were unknown. The patient has had itching within 15 minutes of the shot. Also, the patient had cold chills, tenderness, bad headache, some diarrhea, cold sweats, some swelling of the arm, but itching and headache are the 2 main parts and doesn't know if the second shot was advisable. The outcome of the events itching, cold chills, tenderness, headache, diarrhea, cold sweats and swelling of the arm was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Chills', 'Cold sweat', 'Diarrhoea', 'Headache', 'Peripheral swelling', 'Pruritus', 'Tenderness']",1,PFIZER\BIONTECH,OT 1080196,TX,69.0,F,"a little cough; sore throat; runny nose; a bit of pressure in chest; fever; her heart was beating fast; Granddaughter had covid virus and passed to caller/she tested positive for COVID 19/she was diagnosed with COVID; she was feeling bad; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date: 30Apr2021), via an unspecified route of administration at the right arm on 24Jan2021 07:15 at a single dose for COVID-19 immunization. The patient's medical history included diabetic. The patient's concomitant medications were not reported. It was reported that the patient's granddaughter had COVID virus and passed to the patient. The 2nd dose appointment scheduled for 14Feb2021. Patient stated she had the first dose of the Pfizer COVID 19 vaccine on 24Jan2021 at 0715AM in the right arm. After that, she found out she got infected with COVID 19. On 01Feb2021, she tested positive for COVID 19. On 28Jan2021 (also reported as on 28Jan20201 or 29Jan2021), she was feeling bad. Her little granddaughter had COVID virus (was infected at the school) and passed it on to her. Now she has been going to different places checking it out and she went to urgent care because her heart was beating fast on 02Feb2021. She had an electrocardiogram and her lungs were okay on an unspecified date. They told her was eligible to get an infusion but she doesn't know what it is. The urgent care clinic told her she could get the infusion but then she can't get the second dose of the Pfizer COVID 19 vaccine. She wants to ask if this is true. She was being offered a monoclonal antibody infusion. When ask if this is the first time to call, she stated she called once before right after she found out that she had the COVID 19 infection to ask if she could still get the second shot. She did report at that time that she had gotten the first dose and then tested positive for COVID 19 and she previously provided product information including the lot number from her vaccine card. She added that her heart has been going very fast and has been having fever on 02Feb2021 for two or three days. It is not as high today as it was before. She does want to get the second dose. The first dose helped her so much. On 04Feb2021 (reported as yesterday), she was checked at urgent care because of heart concern and a bit of pressure in chest. Patient stated she only had a little cough, sore throat and runny nose, but she hasn't experienced any other symptoms on an unspecified date. The patient's weight was 54.43 kg on 01Feb2021. The outcome of the events ""fever"" and ""her heart was beating fast"" was recovering, while the outcome of the other events was unknown. Patient was scheduled to receive her second dose on 14Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,01/28/2021,4.0,UNK,,,Medical History/Concurrent Conditions: Diabetic,,,"['COVID-19', 'Chest discomfort', 'Cough', 'Electrocardiogram', 'Feeling abnormal', 'Heart rate increased', 'Oropharyngeal pain', 'Pyrexia', 'Rhinorrhoea', 'SARS-CoV-2 antibody test', 'Weight']",1,PFIZER\BIONTECH, 1080197,,,F,"weakness; Headache; metallic taste in her mouth; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, metallic taste in her mouth, weakness after 2nd dose of vaccine. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Asthenia', 'Dysgeusia', 'Headache']",2,PFIZER\BIONTECH, 1080198,WA,,F,"Caller had symptoms like vertigo and nausea after the 1st dose; Caller had symptoms like vertigo and nausea after the 1st dose; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on an unspecified date, at a single dose, COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced symptoms like vertigo and nausea after the 1st dose. She wanted to know what to take or to do. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Nausea', 'Vertigo']",1,PFIZER\BIONTECH, 1080199,SC,,F,"Arm sore; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received first dose of BNT162B2 (Pfizer CoVid-19 Vaccine), via an unspecified route of administration on 02Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had arm sore on Feb2021 after receiving first dose yesterday (02Feb2021). She was asking if she can take Tylenol. The outcome of the event was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/02/2021,02/01/2021,,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1080200,,72.0,F,"Tested positive for Covid; Really bad headache; Shooting pain; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sales representative. A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# not provided), via an unspecified route of administration on 26Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had really bad headache with shooting pain exactly one week after COVID vaccine (noted on 02Feb2021). The patient also tested positive for COVID one week later on 03Feb2021. Outcome of the events were unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,02/02/2021,7.0,UNK,,,,,,"['Headache', 'Pain', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1080201,MI,68.0,M,"They both had COVID after the 15th, after the first shot; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer-sponsored program. This consumer (wife) reported similar events for herself and her husband. This is 2nd of 2 reports. A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure measurement. Concomitant medications were not reported. The wife reported that on 25Jan2021, she and her husband both had COVID after the 15th, after the first shot. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 25Jan2021. She reported that they were done with quarantine that day, 03Feb2021. Therapeutic measure was taken as a result of the event that included Zepac. And then, her husband took an additional like a steroid. She did not know what he took. But they both took Zepac and their doctor prescribed Zepac, and then her husband took a steroid too. Clinical outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021111355 same reporter/product, events, different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,01/25/2021,10.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure (Verbatim: Blood pressure),,,"['COVID-19', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1080202,,,U,"my left leg started killing me, I cannot put it in the floor anymore; I can hardly walk; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second shot bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date (reported as 21st) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; unknown lot number and expiration date) at unknown vaccination age via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization and was ok. The patient reported that ""I had got this injection on the 21st and I never had any problems but yesterday, my left leg started killing me, I cannot put it in the floor anymore Is this a thing from the injection?"" The patient had this vaccination on 21st, the first shot ok and nothing happed to the patient but yesterday the patient's left leg is bothering the patient and the patient can hardly walk. The patient inquired that can this be because of the vaccination. The patient added that ""That's all I want to know. It is really killing me."" The outcome of the events was unknown. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Gait disturbance', 'Pain in extremity']",2,PFIZER\BIONTECH, 1080203,,,U,"I got the Corona; That's a shock, I got the Corona; I got the Corona; That's a shock, I got the Corona; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on an unspecified date, at a single dose, for COVID -19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first shot of COVID 19 vaccine and had to leave the country. Patient stated, ""I got the Corona. That's a shock, I got the Corona and I am not going to be able to get out from here maybe for another 2 weeks because I have to be in currently in here. So, now what's going on with my first shot and what's going on my second, I have to make an appointment for my second shot or what else?"" Patient added, ""tomorrow I have the second shot, but I am not there, and I have the corona anyhow."" Outcome of the event was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1080204,,,M,"he passed blood in urine; hematoma formation; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as ""Age:79, Unit: Unknown"") received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Jan2021 at single dose COVID-19 immunization; and apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication. Medical history included blood in urine in 2020 (about a year ago). The patient's concomitant medications were not reported. The patient was on Eliquis. He received the COVID vaccine on 30Jan2021. On the 06Feb2021 and 09Feb2021, he passed blood in urine. He reported a similar experience about a year ago for the 1st time after which he saw a urologist who told him it was okay. He is also scheduled to see his urologist on the 25th for a 1-year follow-up. The patient would like to know what the connection is between the COVID vaccine and being on a blood thinner. On unspecified date in Feb2021, the patient had hematoma formation. The action taken in response to the events for suspect drug apixaban was unknown. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,02/01/2021,2.0,UNK,ELIQUIS,,Medical History/Concurrent Conditions: Blood in urine (he passed blood in urine. He reports a similar experience about a year ago),,,"['Blood urine present', 'Haematoma']",UNK,PFIZER\BIONTECH, 1080205,NV,74.0,F,"tongue swelled; shaking like Parkinson's- she was cold; shaking like Parkinson's- she was cold; Headache; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported) (at 74 years of age), via an unspecified route of administration in the arm on 01Feb2021 at a single dose for protection against COVID-19. She will be 75 in September, date of birth unknown. Medical history included cancer in which she doesn't know when was diagnosed but was supposed to be cancer free and hypertension. The patient's concomitant medications were not reported. The patient got to the ER last night (01Feb2021), she went to the health department to get the shot, then the ER. It was reported that last night, the patient was shaking like Parkinson's- she was cold, her tongue swelled, and she had a headache. The patient was not admitted. Shaking like Parkinson's, cold outcome: the patient felt better, she was a little quivery, but was given a steroid and IV last night, and her tongue was not swollen now. Headache: is still ongoing, but improving, she still has it. The outcome of tongue swelled was recovered on an unknown date; shaking like Parkinson's- she was cold and headache was recovering. Therapeutic measures were taken as a result of the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Cancer (supposed to be cancer free); Hypertension,,,"['Feeling cold', 'Headache', 'Swollen tongue', 'Tremor']",UNK,PFIZER\BIONTECH, 1080206,IL,76.0,M,"No problem at first 9 days after injection I woke up with a very sore spot of the injection/his arm is hurting, the same arm he received the injection in; his arm is hurting, states it is his left shoulder and arm, the same arm he received the injection in; his arm is hurting, states it is his left shoulder and arm, the same arm he received the injection in/could be a sign of an infection; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: El3247; expiration date: unknown) at vaccination age of 76-year-old via an unspecified route of administration in the left arm on 02Feb2021 12:00 at a single dose for covid-19 immunization. The patient's medical history concomitant medications were none. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the COVID-19 vaccine in a public health clinic/veterans administration facility. The patient reported that there was no problem at first 9 days after injection. He woke up with a very sore spot on the injection on 11Feb2021. The event did not received treatment for the adverse event. The patient considered the event was non-serious. The patient has not been tested for COVID-19 since the vaccination. The patient further stated that got the Pfizer Covid vaccination on 02Feb2021, but he had no reaction and everything was fine. He mentioned that this morning (11Feb2021) which was 9 days later, his arm was hurting. He stated that it was his left shoulder and arm, the same arm he received the injection in which was given the injection by the employer. The patient wanted to know if it is normal to experience this type of reaction 9 days later. He was wondering if it could be a sign of an infection. The patient was encouraged to reach out to his healthcare provider. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/11/2021,9.0,PUB,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Arthralgia', 'Vaccination site infection', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1080207,CT,88.0,F,"lightheadedness, not sure of her footing and not walking as forcefully as usual; When she turned around she felt like she didn't have control.; lightheadedness, not sure of her footing and not walking as forcefully as usual; When she turned around she felt like she didn't have control.; lightheadedness, not sure of her footing and not walking as forcefully as usual; When she turned around she felt like she didn't have control.; arm hurt a little; This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9263), on the right arm, via an unspecified route of administration on 25Jan2021 at 13:45 at single dose for COVID-19 immunisation. Medical history was reported as none. No family medical history. Concomitant medication included denosumab (PROLIA) given on 06Jan2021. No additional vaccine administered at the same date as BNT162B2 and no prior vaccinations within 4 weeks. No tests were done. On 26Jan2021, it was reported that her arm hurt a little but not much. A day or so later on 27Jan2021, the patient started to experience a lightheadedness, not sure of her footing and not walking as forcefully as usual. When she turned around she felt like she didn't have control. Adds she felt like she walking through a field of marshmallows. She is scheduled to receive the next dose of the vaccine on 15Feb2021 at 14:00. The events did not require physician office or emergency room visit. The vaccine was administered in a school. The outcome of the event arm hurt a little was recovered on 27Jan2021 while for the rest of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,SCH,PROLIA,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dizziness', 'Gait disturbance', 'Loss of control of legs', 'Pain in extremity']",1,PFIZER\BIONTECH, 1080208,MI,35.0,M,"Left lower portion of my leg ached; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received first dose of BNT162B2 (lot number: EL3248), via an unspecified route of administration on the left arm on 28Jan2021 at 08:15 at a single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient had no known allergies. No other vaccine was given in four weeks. No other medications was given in two weeks. No covid prior vaccination. No covid test was done post vaccination. The patient experienced Left lower portion of leg ached. It felt like similar to growing pains experienced as a child. Lasted only one night, the same day as when I received the shot. No treatment was received in response to the adverse event. The next day (29Jan2021) the pain was gone. The patient was not allowed to contact hcp. The patient recovered from the event on 29Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1080209,NM,73.0,M,"feeling in tongue had changed; skin turned rosy on face; lip swollen; digestive issues; gas; Itchy skin; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 26Jan2021 at 11:00 at 73-years-old at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, the patient experienced events and outcomes: feeling in tongue had changed (non-serious) with outcome of recovering, skin turned rosy on face (non-serious) with outcome of recovering, lip swollen (non-serious) with outcome of not recovered, digestive issues (non-serious) with outcome of not recovered, gas (non-serious) with outcome of not recovered, itchy skin (non-serious) with outcome of not recovered; all of which required an emergency room (ER) visit. The patient stated that immediately after the vaccination, he came down with a mild reaction. The patient stated the feeling in his tongue felt off, skin turned rosy, lower lip was swollen, and he has had some gas and digestive issues. The patient stated that he spent an hour and a half in the emergency room (ER), and everything calmed down there, and he was able to go home. The patient stated that he may not take the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/26/2021,0.0,UNK,,,,,,"['Dyspepsia', 'Erythema', 'Flatulence', 'Lip swelling', 'Paraesthesia oral', 'Pruritus']",1,PFIZER\BIONTECH, 1080210,NJ,,M,"Headaches; no taste or smell; no taste or smell; This is a spontaneous report from a non-contactable consumer. A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on an unspecified date for covid-19 immunisation. Medical history included barretts esophagus. The patient's concomitant medications were not reported. The patient experienced headaches on 30Jan2021, no taste or smell on 30Jan2021. No treatment received. The events outcome was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,01/30/2021,,PVT,,,Medical History/Concurrent Conditions: Barrett's esophagitis,,,"['Ageusia', 'Anosmia', 'Headache']",UNK,PFIZER\BIONTECH, 1080211,MS,28.0,F,"Swelling to the upper lip; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received BNT162B2 (Pfizer COVID 19 vaccine), lot no. EL0142 with expiry date Mar2021, via an unspecified route of administration (left arm) on 03Feb2021 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no concomitant medications. The patient got the COVID vaccine today (03Feb2021). She had an adverse reaction. She didn't have it within 15 minutes. She had it several couple of hours later. She had swelling to the upper lip on 03Feb2021. She took a Tylenol and Benadryl. The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/03/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Lip swelling'],UNK,PFIZER\BIONTECH, 1080212,CA,75.0,F,"Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms; Headache; Diarrhea; Chills; Tenderness where the shot area is; Joint pain; Really bad flu; A little bit of a rash from it because my skin is all red from itching; A little bit of a rash from it because my skin is all red from itching; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN5318), via an unspecified route of administration on 02Feb2021 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included high cholesterol and eye disorder. Concomitant medication included atorvastatin, ubidecarenone (COQ-10), colecalciferol (VITAMIN D3), cyanocobalamin (VITAMIN B12), monascus purpureus (RED YEAST RICE) and unspecified OCUVITE for the eyes. On 02Feb2021 at 14:30, within 15 minutes of the vaccination, the patient was itching really bad (itchy in the ears, scalp, neck, chest, arms). The patient was kept in observation after the vaccination for an hour and was treated with diphenhydramine (BENADRYL) which did not seem to help. The patient drover home and went to bed. Her physician suggested that she see an allergist. The allergist was not sure what was in the vaccine and requested the patient ask her doctor for another referral. On 02Feb2021, the patient also experienced headache; diarrhea; chills; tenderness where the shot area was. On 03Feb2021, the patient woke up with cold sweats, like cold wet perspirations and chills again. On an unspecified date in Feb2021, the patient experienced joint pain and felt like she had a really bad flu, developed a little bit of a rash because the skin was all red from the itching, which she couldn't stop. The patient reported that she was treated for the events with diphenhydramine and paracetamol (TYLENOL). She questioned whether there were other reports of itchiness. The clinical outcome of ""within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms"", headache, diarrhea, chills, cold sweat was not resolved; while ""tenderness where the shot area is"", joint pain, really bad flu, ""a little bit of a rash from it because my skin is all red from itching"" was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/01/2021,,UNK,ATORVASTATIN; COQ-10; VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN]; RED YEAST RICE,,"Medical History/Concurrent Conditions: Eye disorder (Concomitant Products Ocuvite: Consumer stated, ""It is for eyes.""); High cholesterol",,,"['Arthralgia', 'Chills', 'Cold sweat', 'Diarrhoea', 'Erythema', 'Headache', 'Influenza', 'Pruritus', 'Rash', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1080213,FL,61.0,F,"Exhausted; Chills; Aches; Fever 100.8; Nausea; This is a spontaneous report from a contactable nurse (patient). This 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN5318) via an unspecified route of administration in the left arm on 26Jan2021 at 14:00 (at the age of 61-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included hypertension and Hashimoto's disease; the patient was allergic to sulfa and penicillin. Concomitant medications included enalapril, sertraline, lansoprazole (PREVACID) and rosuvastatin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140) on 05Jan2021 at 12:15 in the left arm. On 26Jan2021 at 15:00, the patient experienced exhausted, chills, aches, fever 100.8 and nausea. All the events were considered as non-serious. Corrective treatments taken as a result of the events included paracetamol (TYLENOL) and she went to bed-slept for 14 hours straight. The patient recovered from the events on an unspecified date. The patient had not COVID-19 prior to vaccination and she was not tested for COVID-19 post vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,SEN,ENALAPRIL; SERTRALINE; PREVACID; ROSUVASTATIN,,Medical History/Concurrent Conditions: Hashimoto's disease; Hypertension; Penicillin allergy; Sulfonamide allergy,,,"['Body temperature', 'Chills', 'Fatigue', 'Nausea', 'Pain', 'Pyrexia']",2,PFIZER\BIONTECH, 1080214,OH,36.0,F,"Moderate head/headache; jaw clenching; chills; feeling unwell; This is a spontaneous report from a contactable consumer who reported for herself. A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on 15Feb2021 at 15:15 (at the age of 36-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included sub clinical hyperthyroidism and obesity, both from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (received within two weeks of vaccination) included celecoxib (CELEXA), bupropion hydrochloride (WELLBUTRIN), vitamin D NOS (VITAMIN D) and levothyroxine, all for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received penicillin and amoxicillin and experienced allergy. On 16Feb2021 at 14:00 the patient experienced moderate head/headache, jaw clenching, chills and feeling unwell. The clinical course was reported as follows: ""Moderate head began 23 hours later. Then chills, feeling unwell, and my jaw clenched shut. I slept all day and night and finally took Tylenol and a prescribed Ativan for the headache and jaw clenching. It did not help. I put a heating pad on my shoulders, neck, and head for the past two hours and that helped. I would not have been able to finish work if I had to work today. It was terrible."" The events were reported as non-serious and did not result in hospitalization. It was reported that treatment was not received for the events. The clinical outcomes of the events moderate head/headache, jaw clenching, chills and feeling unwell were all not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/16/2021,1.0,WRK,CELEXA [CELECOXIB]; WELLBUTRIN; VITAMIN D [VITAMIN D NOS]; LEVOTHYROXINE,,Medical History/Concurrent Conditions: Hyperthyroidism (Sub clinical); Obesity,,,"['Chills', 'Headache', 'Malaise', 'Muscle tightness']",1,PFIZER\BIONTECH, 1080215,CT,66.0,F,"Arm soreness at vaccination site; This is a spontaneous report received from a non-contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201, expiry date unknown), via an unspecified route of administration, on 19Feb2021 09:15, at single dose, for COVID-19 immunization. Medical history included asthma and penicillin allergy. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 19Feb2021 at 11:00, the patient experienced arm soreness at vaccination site. Treatment included Aspirin. The outcome of the event was unknown. The reporter assessed the event as non-serious. No follow-up attempts are needed. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Asthma; Penicillin allergy (known_allergies: Penicillin),,,['Vaccination site pain'],UNK,PFIZER\BIONTECH, 1080216,CA,36.0,F,"Redness at injection site on day 2; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN2600) on left arm, via an unspecified route of administration on 18Feb2021 15:00 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced redness at injection site on day 2 on 20Feb2021 13:30. There was no treatment received for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The event was reported as non-serious. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/20/2021,2.0,MIL,,,,,,['Vaccination site erythema'],UNK,PFIZER\BIONTECH, 1080217,SC,72.0,M,"covid test result was Positive/sore throat and headache; aches; Still sick; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of bnt162b2 (lot number EL9262), via an unspecified route of administration in right arm on 13Feb2021 13:00 at single dose for covid-19 immunization. Medical history included Diabetes. The patient received unspecified medications within 2 weeks of vaccination. Since the vaccination, patient had been tested for COVID-19. The Nasal Swab (Aegis) was tested on 13Feb2021. The covid test result was Positive. In Feb2021, the patient had aches, sore throat and headache. Came down with full blown Covid moderate to severe. Still sick. Patient was reluctant to get his second shot and was sure it serves no purpose. No treatment received for events. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Diabetes,,,"['COVID-19', 'Illness', 'Pain', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1080218,AZ,,F,"Severe explosive diarrhea; This is a spontaneous report from a contactable female other health professional reported for herself. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on an unspecified date at 15:45 (Lot number: EL9269) via an unspecified route of administration in the left arm at single dose for COVID-19 Immunization in the Public Health Clinic. The patients medical history included She had sulfa and latex allergy. The patients concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested after vaccination. On 14Feb2021 04:30 the patient had severe explosive diarrhoea within 12 hours of injection. Diarrhoea, several times per day, accompanied by loud rumbling, bowel sounds. Bowel movements would be watery and worsen with the ingestion of any form of solid foods. No bloating or cramps. The event assessed as serious (medically significant). The patient didn't receive treatment. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the strong temporal relation, the association between the event diarrhea and the administration of the vaccine cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,02/14/2021,,PUB,,,Medical History/Concurrent Conditions: Latex allergy; Sulfonamide allergy,,,['Diarrhoea'],1,PFIZER\BIONTECH, 1080219,,,F,"anaphylactic reaction; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction on an unspecified date, which caused Emergency room/department or urgent care. Therapeutic measures were taken as a result of anaphylactic reaction included unspecified treatment. The outcome of event was recovered. No follow-up attempts are possible. information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,['Anaphylactic reaction'],1,PFIZER\BIONTECH, 1080220,,,F,"Flu-like symptoms; joint pain; This is a spontaneous report from a contactable other-HCP. A 64-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on an unspecified date, lot number unknown, at single dose for COVID-19 immunisation. The patient medical history included breast cancer. The patient concomitant mediations included palbociclib (IBRANCE, strength: 125mg) by mouth at 125mg once daily at cycle: 21 days on, 7 days off from 2019 and ongoing for breast cancer. The patient previously received the first dose of bnt162b2 on an unspecified date, lot number unknown, at single dose for COVID-19 immunisation. The patient experienced flu like symptoms and joint pain after the injection but had now resolved (on unknown date). It was unknown if MD is aware but the patient was advised to notify MD of any symptoms. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,IBRANCE,,Medical History/Concurrent Conditions: Breast cancer,,,"['Arthralgia', 'Influenza like illness']",2,PFIZER\BIONTECH, 1080221,,,M,"Patient was hospitalized for covid pneumonia (positive for covid infection); This is a spontaneous report from a contactable physician. A 77-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at single dose for COVID-19 immunization. Medical history included patient's wife had contracted covid infection the week prior the patient received his first dose, in Jan2021, and patient did not have symptoms of covid infection at time of 1st dose vaccine. Concomitant medications were not reported. Patient experienced covid pneumonia in Feb2021 (positive for covid infection in Feb2021) and was hospitalized on 08Feb2021. Patient received treatments as follows: 12L O2, steroid, remdesivir and convalescent plasma. Patient was fully recovered from the event in Feb2021. Information on the lot/batch number has been requested.; Sender's Comments: Covid 19 pneumonia is assess as an intercurrent medical condition based on patients exposure to a patient who is positive for Covid 19 prior to vaccination. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/04/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Exposure to COVID-19 (patient did not have symptoms of covid infection at time of 1st dose vaccine),,,"['COVID-19 pneumonia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1080222,NM,72.0,M,"Pulmonary embolism; Multiple clots in his lungs; Shortness of breath; This is a spontaneous report from a contactable consumer (patient wife). A 72-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown and expiration date not reported), via an unspecified route of administration on 10Feb2021 at a single dose for Covid-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine. The patient previously took first dose of bnt162b2 (EL8982) on 19Jan2021. The reporter (wife) stated that she and her husband both took the Covid vaccine. The patient (husband) is the one who have the adverse reactions. On 19Jan2021, she and her husband had the first shot, the Pfizer Covid shot. On 10Feb2021, they had the second shot. Just today she picked her husband from the hospital, they dismissed him for today because on 18Feb2021, she had to take him to emergency room because he had pulmonary embolism. He has multiple clots in his lungs. This is nothing that they dealt before with him. The reporter is afraid that it might be related to have taken the vaccine. Reporter stated that when she took him to the emergency room, it was 18Feb2021. Now he had a little shortness of breath for few days before the 18th but they didn't realize that he was having a big problem. He fully developed this on 18Feb2021. The reason for hospitalization was pulmonary embolism and blood clots in his lungs. He is little bit slow like the reporter said she got him to the hospital where he stayed 3 days she guess with pulmonary embolism, from 18Feb2021 to 21Feb2021. He had lot a of lab work while he was in hospital on these days the wife described. He had blood work, Echocardiogram, CAT scan, Ultrasounds, Chest X-ray, Covid rapid test, they haven't got back the result yet. Outcome of the events was unknown.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/10/2021,02/18/2021,8.0,UNK,LEVOTHYROXINE,,,,,"['Blood test', 'Chest X-ray', 'Computerised tomogram', 'Dyspnoea', 'Echocardiogram', 'Pulmonary embolism', 'Pulmonary thrombosis', 'SARS-CoV-2 test', 'Ultrasound scan']",2,PFIZER\BIONTECH, 1080223,MT,78.0,M,"muscle stiffness and soreness - legs,arms, shoulders, etc.- for the past 14days or so - since injection.; muscle stiffness and soreness - legs,arms, shoulders, etc.- for the past 14days or so - since injection.; Movement, sleeping, bending, etc.,almost impossible; Movement, sleeping, bending, etc.,almost impossible; This is a spontaneous report from a contactable consumer reported for himself. A 78-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=em9801), via an unspecified route of administration at the age of 78 years old on 12Feb2021 at single dose on arm left for covid-19 immunisation. Medical history was none. No Allergies to medications, food, or other products. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received no other medications within 2 weeks of vaccination. The patient's concomitant medications were none. The patient experienced muscle stiffness and soreness - legs, arms, shoulders, etc.- for the past 14 days or so - since injection. Movement, sleeping, bending, etc., almost impossible. 4- 200mg-ibuprofen helps for about 4 hrs. The onset date for the adverse events was reported as 13Feb2021. The events outcome was not recovered. The seriousness of the events was reported as no.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,PUB,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: No Allergies to medications, food, or other products",,,"['Insomnia', 'Movement disorder', 'Musculoskeletal stiffness', 'Myalgia']",1,PFIZER\BIONTECH, 1080267,NY,70.0,F,Itching of tongue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PUB,,,,,Reaction to flu shot and other vaccine,['Tongue pruritus'],1,JANSSEN,IM 1080268,VA,54.0,M,"Vaccinated at approx 1300 hrs. I began feeling chilled 6 hours later. Chills continued for hours. I developed a significant headache. Also experienced some body aches. Took my temperature via oral thermometer at 10:00 PM and it was 101.5. Went to bed at approx 11:00 PM wearing all my clothes and under a quilt and two wool blankets. Chills continued, but then I also began sweating profusely. I did not rest well and was up approx every hour drinking water and urinating. I noticed an elevated heart rate for several hours through the night. cont'd below",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,"Singulair, Omeprazole, Escitalpram, NAC, Probiotics",,Asthma,,,"['Chills', 'Headache', 'Heart rate increased', 'Hyperhidrosis', 'Nocturia', 'Pain', 'Poor quality sleep', 'Pyrexia', 'Thirst']",1,JANSSEN,IM 1080280,MD,31.0,F,"Chills hit me suddenly 6hrs after getting the shot. I was freezing. Two hours later, extremely tired and sore. I feel groggy. 3hrs later, I cannot sleep although I am so tired. Chugged water and took a hot bath but was so tired had to get out of bath. Zero appetite.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,PUB,Adderall XR 15mg,None,None,,None,"['Chills', 'Decreased appetite', 'Fatigue', 'Feeling cold', 'Pain', 'Sleep disorder', 'Somnolence']",1,JANSSEN,SYR 1080281,IL,62.0,F,"8 hours after vaccination I got headache, fever (101), fatigue and body aches. Woke up in the middle of the night with headache and slight nausea. The next morning and through the day/ night had some joint pain and extremely tired.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,OTH,Klonopin Doxepin Zofran,None,None,,None,"['Arthralgia', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1080291,VA,39.0,M,"Soreness, shivering/shaking and fever of nearly 103 degrees began around 7:30 pm , followed by significant sweating.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/07/2021,0.0,UNK,Glycopyrolate 1mg per day,None,None,,None,"['Chills', 'Hyperhidrosis', 'Pain', 'Pyrexia', 'Tremor']",1,JANSSEN,SYR 1080315,,22.0,F,"I first noticed that I was extremely cold and could not get warm at about 11 pm on the evening of my vaccine. I then realized it was getting worse, and I was shivering uncontrollably despite sitting in front of a space heater in warm clothing and wrapped in a blanket. I checked for a fever, but my temp was only 99. I fell asleep around 1 am, and woke up at 5 am (3/8/21) to a splitting headache, extreme thirst, slight nasal congestion, muscle soreness, fatigue, and nausea. These symptoms feel almost identical to the symptoms I experienced when I contracted COVID-19 in September 2020 at my university.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,PHM,Esomeprazole magnesium Vitamin D3 Vitamin C Iron Mirtazipine,None,GERD GAD,,"Severe anaphylaxis allergies to tree nuts, peanuts, coconut, sesame seeds. No known medication allergies.","['Chills', 'Fatigue', 'Feeling cold', 'Headache', 'Myalgia', 'Nasal congestion', 'Nausea', 'Thirst']",1,JANSSEN,SYR 1080316,MD,20.0,F,"5 hours after the vaccine, I started having a sore arm at the injection sight and a low grade fever of 100.0 with chills and I was uncontrollably shaking. I took ibuprofen at 8:00pm. That night at about 9:00 my fever was 100.8 and I felt extreme fatigue. I woke up at 3:30am feeling both extremely hot and cold with a bad headache and my temperature was 101.5. I took ibuprofen again at 3:30am. I then woke up at 5:15 am with a horrible headache and was very hot and sweating. I put cold compresses on my forehead and back of my neck which helped. The entire night, my arm with the injection site was very painful and stiff to move.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,PHM,,,,,,"['Chills', 'Fatigue', 'Feeling of body temperature change', 'Headache', 'Hyperhidrosis', 'Injected limb mobility decreased', 'Injection site pain', 'Pyrexia', 'Tremor']",UNK,JANSSEN, 1080329,NY,,U,"Anaphylactic reaction; A spontaneous report was received from a physician concerning patients (ages and genders not specified) who received Moderna's COVID-19 vaccine (mRNA-1273) or Pfizer's COVID-19 vaccine and experienced anaphylactic reaction. The patients' medical history was not provided. Concomitant product use was not provided by the reporter. On unknown in Dec 2020, the patients received dose of either mRNA-1273 or Pfizer's COVID-19 vaccine (batch number unknown, route of administration, site of injection not provided) for prophylaxis of COVID-19 infection. On unknown date in Dec 2020, the physician reported that patients (who were employees) received the vaccine and one of them ended up in intensive care unit for several days. Within a week or so, another 2 patients had less severe, but did have anaphylactic reaction to the vaccine. Initially was Pfizer, and Moderna came in later. There were a total of around 5 to 6 patients out of about sixty five thousand in which vaccines were administered. The physician emphasized that this was for both vaccines, not just Moderna. Action taken with mRNA-1274 was not provided. The outcome of event anaphylactic reaction was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of anaphylactic reaction, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/01/2020,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Anaphylactic reaction'],UNK,MODERNA,OT 1080330,IL,51.0,F,"Received the second dose of the Moderna vaccine two weeks after the first dose; A spontaneous report was received from other health professional concerning a 51-years-old female patient who received second dose of Moderna's (mRNA-1273) COVID-19 Vaccine two weeks after the first dose (inappropriate schedule at vaccine administered). The patient's medical history included breast cancer, broken leg and was very stressed. No concomitant medications were provided. The patient received their first of two planned doses of mRNA-1273 (Lot/batch number: unknown) on 22 Jan 2021. On 05 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot/batch number: 012M20A) for prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient received the second dose of the Moderna vaccine two weeks after the first dose (inappropriate schedule at vaccine administered). No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The outcome of the event the patient received the second dose of the Moderna vaccine two weeks after the first dose was considered recovered.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 012M20A with second dose) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,02/05/2021,14.0,UNK,,Breast cancer,Medical History/Concurrent Conditions: Broken leg; Stress,,,['Inappropriate schedule of product administration'],2,MODERNA,OT 1080331,MS,70.0,F,"Choked with food; Started wheezing trying to expel the food; felt like her throat closed when choking with the food; Hard to breathe when choking with the food; Difficulty lifting her left arm; A spontaneous report was received from a consumer concerning a 70 years-old, female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced choking with food/ choked on food, Started wheezing trying to expel the food/ wheezing, felt like her throat closed when choking with the food/ throat tightness, hard to breathe when choking with the food/ breathing difficulty, difficulty lifting her left arm/ Arm discomfort. The patient's medical history was not reported. Concomitant product use included blood pressure medication. On 02 Feb 2021, prior to the onset of the events, the patient received the first dose of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 02 Feb 2021, approximately 3 hours after getting the vaccine, she started eating and choked with the food, and when trying to expel it, she started wheezing, felt like her throat closed and was hard to breath more than usual for this kind of situations. She also has difficulty lifting her left arm. The seriousness criteria were considered as medically significant for the event choked on food. Treatment information was not reported Action taken with mRNA-1273 in response to the events is not reported. The events choking with food/ choked on food, Started wheezing trying to expel the food/ wheezing, felt like her throat closed when choking with the food/ throat tightness, hard to breathe when choking with the food/ breathing difficulty, difficulty lifting her left arm/ Arm discomfort were considered resolved.; Reporter's Comments: This case concerns a 70-year-old female who experienced a serious unexpected event of choking along with NS unexpected events of throat tightness, wheezing, dyspnea, and arm discomfort. The events occurred 3 hours after the first dose of mRNA-1273. Treatment not reported. Event outcomes resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Choking', 'Dyspnoea', 'Limb discomfort', 'Throat tightness', 'Wheezing']",1,MODERNA,OT 1080333,CA,,M,"Possible vaccination with 1.5 dose instead of 1 dose; vaccination adverse reaction; A spontaneous report was received from a consumer, concerning a male patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) 1.5 dose instead of 1 dose.(PT: Accidental Overdose) with an associated unknown side effects (PT: Vaccination adverse reaction) The patient's medical history was not provided. No relevant concomitant medications were reported. On unspecified date in February 2021, the patient received one of the two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date in February 2021, the patient received 1.5 dose of vaccine instead of 1 dose. Vaccination adverse reactions was reported by the patient after being given the vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event received 1.5 dose instead of 1 dose was considered resolved. The outcome of Vaccination adverse reactions was not reported; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273 (lot # unknown) with an associated vaccination complications (unspecified) reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Accidental overdose', 'Vaccination complication']",1,MODERNA,OT 1080335,,,U,"Anaphylaxis; A spontaneous report was received from a physician assistant concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis. The patient's medical history was not provided. No relevant Concomitant medications were reported. On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On an unknown date, after receiving vaccine, the patient died due to anaphylaxis. No further details were available at the time of this report. Treatment for the event was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event anaphylaxis was fatal .The patient died on an unspecified due to anaphylaxis. Autopsy details were not provided.; Reporter's Comments: Very limited information regarding the event of anaphylaxis has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Anaphylaxis",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Anaphylactic reaction'],UNK,MODERNA, 1080336,,,F,"Borderline seizures; Fever of 104 F; A spontaneous report was received from a consumer (patient), a 67 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced borderline seizures (seizure) and fever of 104 F (pyrexia). The patient's medical history was not provided. Concomitant medication included tofacitinib citrate. On an unknown date, about a month ago, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), intramuscularly for the prophylaxis of COVID-19 infection. On an unknown date, the patient had a fever of 104 Fahrenheit (F) for 3 days and was very sick with ""borderline"" seizures. The patient's blood work showed C-reactive protein (CRP) was 31 (unknown units), and white blood cell (WBC) count was low. The patient's physician was very concerned. No treatment medications were reported. Action taken with the second dose of mRNA-1273 in response to the events was not reported. The outcome for the event, borderline seizures was considered as unknown, and that of fever of 104 F was considered as recovered.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,XELJANZ,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Body temperature', 'C-reactive protein', 'Pyrexia', 'Seizure', 'White blood cell count']",1,MODERNA,OT 1080337,MD,41.0,F,"High blood pressure; Bad headache; Hallucinations; Temperature went to 104.6F; A spontaneous report (), was received from a consumer (patient), a 41 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced hallucinations, high blood pressure (hypertension), temperature went to 104.6 F (pyrexia), and bad headache (headache). The patient's medical history included COVID-19 diagnosed in Oct 2020. Concomitant medication was not provided. On 05 Feb 2021, approximately one day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: 030M20A) intramuscularly for the prophylaxis of COVID-19 infection. On 06 Feb 2021, post vaccination, the patient's body temperature was 104.6 F, and hallucinations. On 09 Feb 2021, the patient woke up with high blood pressure and had a bad headache. Subsequently, the patient went to emergency room on the same day. Treatment medications included acetaminophen and ibuprofen. Action taken with the second dose of mRNA-1273 in response to the events was not reported. The outcome for the events, hallucinations, high blood pressure, temperature went to 104.6 F, and bad headache were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/06/2021,1.0,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Blood pressure measurement', 'Body temperature', 'Hallucination', 'Headache', 'Hypertension', 'Pyrexia']",1,MODERNA,OT 1080338,CT,,M,"Received total of three doses of MODERNA COVID 19 Vaccine; A spontaneous report was received from an HCP concerning an 86 years old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced medication error of received total of three doses of moderna COVID 19 vaccine. The patient's medical history was not reported. Concomitant medications were not reported. On 14 Jan 2021, prior to the onset of the events, the patient received two doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient received a third dose of mRNA-1273 (Batch number: unknown) via intramuscular for prophylaxis of COVID-19 infection. Laboratory test was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the events are unknown; Reporter's Comments: This report refers to a case of an 86-year old male patient who received a total of 3 doses of mRNA-1273 (lot # not provided) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Accidental overdose'],3,MODERNA,OT 1080341,,20.0,F,"benign PVCs; felt funny; heart pounding on/off for a good number of days after the episode; Ideopathic peripheral nueropathy; Initial information received in courtesy from Pfizer on 24-Feb-2021 regarding an unsolicited valid non-serious case from other health professional. This case involves a 20 years old female patient (62.5 cm and 112 kg) who experienced idiopathic peripheral neuropathy (neuropathy peripheral), benign PVCs (Premature ventricular contractions) (ventricular extrasystoles), felt funny (feeling abnormal) and heart pounding on/off for a good number of days after the episode (palpitations), after receiving DIPHTHERIA AND TETANUS TOXOIDS, HEPATITIS B IMMUNE GLOBULIN, YELLOW FEVER VACCINE and ORAL POLIO VACCINE. The patient's medical history included seasonal, animal and food allergies; adverse reactions to multiple medicines-some severe. Past medical treatment(s), vaccination(s), family history and concomitant medication(s) were not provided. On an unknown date in Aug-1988, the patient received a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS (produced by unknown manufacturer), HEPATITIS B IMMUNE GLOBULIN, YELLOW FEVER VACCINE and ORAL POLIO VACCINE not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination ahead of travel. Because patient had so many at once, was asked to remain for a little while ; within a very short time, patient told the clinician that she felt funny (feeling abnormal, non-serious, same day latency) and heart pounding on/off for a good number of days after the episode (palpitations, non-serious, unknown latency) following the administration of DIPHTHERIA AND TETANUS TOXOIDS, ORAL POLIO VACCINE, YELLOW FEVER VACCINE and HEPATITIS B IMMUNE GLOBULIN. Patient reported that clinician checked her and said didn't like what she was seeing and administered EPINEPHRINE (all of this was recorded on her yellow card) and have not had any vaccines then. Patient rather assumed the lasting effect was from the epi-pen, but now, not so certain. On an unknown date in Jul-2014, the patient developed a serious idiopathic peripheral nueropathy (neuropathy peripheral) (unknown latency) following the administration of DIPHTHERIA AND TETANUS TOXOIDS, ORAL POLIO VACCINE, YELLOW FEVER VACCINE and HEPATITIS B IMMUNE GLOBULIN. This event was assessed as medically significant. it was reported that it came on suddenly, progressed quicky over a matter of weeks, then leveled off and subsided over the years , no cause was identified, though doctors felt likely result of a virus (unspecified). On an unknown date , (roughly 7-8 years ago from the administration of COVID-coronavirus vaccine) the patient developed a non-serious benign PVCs (Premature ventricular contractions) (ventricular extrasystoles) (unknown latency) following the administration of DIPHTHERIA AND TETANUS TOXOIDS, ORAL POLIO VACCINE, YELLOW FEVER VACCINE and HEPATITIS B IMMUNE GLOBULIN. (Also reported 5-6 years ago- likely result of hormonal changes and eventually subsided and patient had not felt them in years). No laboratory data was reported. No clear family history relevant to the adverse events that patient experience, other than many relatives with multiple and sever allergies. The patient recovered from the events neuropathy peripheral and ventricular extrasystoles, while was unknown for the other two events. Information on the batch number to be requested. Additionally reported, at the age of 53 the patient received COVID-19 (coronavirus disease 2019, BNT162B2, first dose, ENS318, difficult to read handwriting, so if lot males non sense, try EN5318) vaccine (Pfizer) on 26-Jan-2021. Also, roughly after 7 minutes after receiving the COVID-19 vaccine, she experienced a dramatic jump in pulse rate (tachycardia -pulse rate 152). She requested assistance and the doctor and nurses at the vaccination site took her to an area, where they found her blood pressure had also jumped (blood pressure spiked to 159/98 and 169/92) and she was having irregular beats (irregular rhythm). They asked if her breathing was ok and if her throat felt ok. Her mouth was dry, and she felt a tightness in her chest, but otherwise no rashes or other clear sign of anaphylaxis. They monitored her for roughly 1.5 hours, requesting help from the EMT (Emergency medical technician) stationed there, who did a brief EKG (Electrocardiography), which showed tachycardia but did not picked up the irregular beats. Upon hearing they had heard and seen irregular beats on the blood pressure monitor, she explained that she had a history of benign PVCs (Premature ventricular contractions), but not experienced them in years and was not medicated for them. Eventually the doctor let her go when the blood pressure came down to 138/89 with a resting pulse rate of 112-114 (still significantly higher than normal). He advised her to follow up with her doctor right away, preferably that same day. Her blood pressure and pulse rate eventually returned to her normal levels 11 hours after the administration of the vaccine. As the tachycardia subsided, she could feel frequent irregular beats. The next day she continued to experience the irregular beats on/off all day long and also experienced a crushing fatigue t7o the point where she needed to take day off from work, something she rarely do. The fatigue subsided by the end of the week, but the irregular heartbeats continued for roughly 10 days before they subsided to the point of not being as noticeable. Patient was on cyanocobalamin (B-12) tablet .That evening and over a next few days, she followed up with her primary care physician, her allergies and ultimately the cardiologist, who ordered a 2 week holter monitor results were still pending. Weighing the risk of COVID, the benefits of the vaccine, history of patient's allergies and reaction to her first dose (particularly the irregular beats which h continued past the initial day of the vaccine). Her allergist and cardiologist suggested to hold on the second vaccine until they can better assess her status and why reaction occurred. A follow up with another allergist who specialized in the vaccine reactions also suggested that she have a cardiac stress test prior to considering a second dose.; Sender's Comments: This case involves a 20 years old female patient who presented with peripheral neuropathy, ventricular extrasystoles, feeling abnormal and palpitations, after vaccinations with DIPHTHERIA AND TETANUS TOXOIDS, HEPATITIS B IMMUNE GLOBULIN, YELLOW FEVER VACCINE and ORAL POLIO VACCINE. Time to onset was compatible with the events feeling abnormal and palpitations, while it was too long to consider for the other two events. The patient's medical history included seasonal, animal and food allergies; adverse reactions to multiple medicines-some severe. However, other relevant patient's medical condition at the time of vaccination, immune status, history of similar episodes with previous vaccinations and lab tests were not reported. Based upon the reported information, the role of an individual vaccine cannot be assessed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,08/01/1988,07/01/2014,9465.0,UNK,,Allergy to animal (since child); Food allergy (since child); Seasonal allergy (since child),,,,"['Blood pressure increased', 'Chest discomfort', 'Dry mouth', 'Dysgraphia', 'Electrocardiogram abnormal', 'Electrocardiogram ambulatory', 'Fatigue', 'Heart rate increased', 'Heart rate irregular', 'Tachycardia']",UNK,SANOFI PASTEUR,OT 1080359,LA,28.0,F,"I took the vaccine around 8:15 am at Hospital. They had a special event for Employees. After I was home I felt extremely tired and that improved after i laid down for a bit. However, around 7 PM I became very cold and had a temperature of 100.3 with chills/shakes. It has lasted into the next day with chills being on and off. I experienced muscle cramps as well has some chest discomfort.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/07/2021,03/07/2021,0.0,UNK,Tylenol and albuterol sulfate maybe an hour prior to vaccination,Acid reflux,Asthma,,,"['Body temperature increased', 'Chest discomfort', 'Chills', 'Fatigue', 'Feeling cold', 'Muscle spasms']",1,JANSSEN, 1080360,NE,38.0,F,"about 7 hours after receiving the vaccine, I developed strong muscle and joint pain, fatigue, and a fever. Overnight the fever got worse and I developed a headache. I also felt tired. A hot shower and some Advil about 24 hours after the vaccine helped. Within 24 hours of symptom onset, they were better/gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,UNK,"Zyrtec, Flonase, Plexus X Factor (multivitamin), Plexus Immune, Plexus Slim",none,"diagnosed with shingles in September of 2020, but no current symptoms",,"allergic to amoxicillin, seasonal allergies","['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,JANSSEN,IM 1080361,NY,61.0,F,"Extreme fatigue, chills but not a fever, joints very achy, headache, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,None,,"Remission of breast cancer. Taking Anastrozole daily. Controlled high blood pressure, Controlled asthma and environmental allergies",,"Cleocin, Sulfa drugs, steri-strips","['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Nausea']",1,JANSSEN,SYR 1080362,,35.0,M,Patient had a syncopal episode post vaccination with brief unresponsiveness lasting about 5-10 seconds . At time of episode pallor and diaphoresis was noted and right after brief LOC he became AXOx3. The patient was placed in the Trendelenburg position while being evaluated by EMS:- Vitals: B/P 99/58 HR: 60 RR20 O2sat 98%. Blood glucose 132. Hospital transfer was recommended but the patient refused. Oral fluids were administered and repeat vitals showed improvement in BP to 104/68. Patient ambulated without assistance and reported a return to baseline. Signed to go home against medical advise. Encouraged to seek medical attention if symptoms returned and see PCP. Left in the company of his spouse,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,,,Denies Admits to prior vagal response to blood draw but no syncope.,,None Known,"['Blood glucose increased', 'Hyperhidrosis', 'Loss of consciousness', 'Pallor', 'Syncope', 'Unresponsive to stimuli']",UNK,JANSSEN, 1080368,PA,63.0,M,Vertigo,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/08/2021,2.0,PVT,"Synthroid, simvistatin, omeprezole, vitamins e and d",None,None,,None,['Vertigo'],UNK,JANSSEN, 1080370,MA,65.0,M,mild fever and headache starting approximately 6 hours after injection. 100.4F by digital no-touch thermometer acquired in ear. Fever gone after 12 hours. Headache gone after 18hours with 400mg Advil taken 18 hours after start of fever.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PUB,Latanoprost 0.005% eye drops,none,dry-eye,,none,"['Body temperature increased', 'Headache', 'Pyrexia']",UNK,JANSSEN,IM 1080371,MD,30.0,M,"Went to bed after getting my shot at 11:00 PM on 3/7/2021, feeling no symptoms. Woke up at 5:10 AM the next day on 3/8/2021 feeling tired, sore, and a little nauseous, with a headache. These symptoms are very similar to how my COVID symptoms were in early October 2020",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,PVT,I have a blood pressure medicine (It's not available to me at the moment to get the name) that I started taking less than a month ago,None,"Obesity, High Blood Pressure",,none,"['Fatigue', 'Headache', 'Nausea', 'Pain']",1,JANSSEN,SYR 1080378,VA,61.0,F,Work up at 12:30 a.m. very hot and nauseous. When I tried to stand up I fainted. When I came to I crawled to the bathroom and vomited several times. Continued to run fever for about an hour or so. Then headache began. As of 7:00 I still feel nauseous and have a slight headache.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/08/2021,1.0,OTH,,,,,,"['Feeling hot', 'Headache', 'Nausea', 'Pyrexia', 'Syncope', 'Vomiting']",1,JANSSEN,SYR 1080389,NY,36.0,F,"Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/07/2021,0.0,PHM,,,,,,"['Dysphagia', 'Paraesthesia', 'Throat tightness']",1,JANSSEN,IM 1080391,IN,56.0,M,"Fever, chills, headache, body aches came on on suddenly at 11pm. Took ibuprofen at 5 a.m. Fever and chills gone by 7a.m. Then felt low energy, tired on 3/6 fine by 6 p.m.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PUB,"Lipitor generic, Claratin generic",None,"Diverticulitis, cholesterol","Flu shots in past, have felt poorly but not like this",No,"['Asthenia', 'Chills', 'Fatigue', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1080393,CA,32.0,M,"Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Additional Details: patient bp was recorded as 85/75mmhg at the time patient felt light headednes. rechecked again after 15 minutes and pt felt better and bp recorded-120/79mmhg",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PHM,,,,,,"['Dizziness', 'Hypotension', 'Nausea']",1,JANSSEN,IM 1080394,IN,58.0,M,"Started with a fever - that began about 6 hrs after the injection. That lasted a little more than 24 hours, then went away. Last night - about 55 hrs after that vaccine, I have developed an itching rash over most of my body - I still have it as of this morning. Also, slight swelling of my lips",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,OTH,Flomax & daily Mutli vitamin,None,None,,None,"['Lip swelling', 'Pyrexia', 'Rash', 'Rash pruritic']",1,JANSSEN,SYR 1080396,MA,30.0,F,"Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,,,,,,"['Dizziness', 'Syncope', 'Unresponsive to stimuli']",1,JANSSEN,IM 1080398,TX,40.0,M,"Site: Swelling at Injection Site-Mild, Additional Details: After giving the vaccination, patient developed immediate reaction at injection site: warmth, swelling at the site. He did bleed a little and after putting on the bandaid, I went to grab an ice pack and I started applying the icepack to the site. Checked on patient every 5 minutes. Even did a follow up call to him an hour later and he told me he was doing okay. No more warmth in the area, some pain but the swelling had gone down substantially. I suggested to continue to monitor, apply icepack",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PHM,,,,,,"['Immediate post-injection reaction', 'Injection site haemorrhage', 'Injection site swelling', 'Injection site warmth', 'Skin reaction']",1,JANSSEN,IM 1080399,,67.0,F,"Overnight on the 6th - muscle aches, chills, fever, headache, weakness. Starting on Sunday morning the 7th - bad nausea all day with vomiting for 12 hours. Barely able to have an ice chip.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,UNK,,none,none,,,"['Asthenia', 'Chills', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",UNK,JANSSEN,IM 1080401,VA,22.0,M,"Janssen COVID-19 Vaccine EUA Headache and body aches 10pm. High fever to 102 by 1pm with severe head and body aches, shivering, dizziness, unsteadiness. Tried drinking water, resting. Rapid heart beat at 120bpm. Couldn't sleep, so woke parent at 5:45a. Tylenol acquired from pharmacy and given at 6:30am. By 7:30a, fever under 101, HR 107 bpm. Severe headache and body aches persist. Injection site soreness and generally feeling awful. Continuing to hydrate with electrolyte water and plain water.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/07/2021,0.0,PUB,aspirin prn,none,none,"HPV, Shaking, tremors, almost passed out. Age about 14?",intolerance to augmentin,"['Balance disorder', 'Chills', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Headache', 'Heart rate increased', 'Injection site pain', 'Insomnia', 'Pain', 'Pyrexia']",UNK,JANSSEN,SYR 1080404,NY,88.0,M,"Severe fatigue, lethargy observed by family members on date of discharge from sub-acute nursing care to home 02/03/2021 and subsequently on 02/04/21 with complaint of shortness of breath. Continued lethargy and shortness of breath on 02/05/21, 02/06/21. Lethargy, shortness of breath and loss of appetite, chills, on 02/07/21. Less lethargic on 02/08/2021 but worsened shortness of breath and loss of appetite. Patient requested 911 call on afternoon of 02/09/2021 for shortness of breath. Rapid Covid screen at ER was positive and staff reported beginning treatment with dexamethasone and remdesivir. Hospital staff reported to family that patient had pneumonia, congestive heart failure, confusion on 02/10/2021. Nursing staff reported patient was getting antivirals and antibiotics. Patient was transported for care by pulmonary specialist at Hospital on 02/13/2021.",Yes,02/14/2021,Not Reported,Yes,6.0,Not Reported,N,01/25/2021,01/25/2021,0.0,SEN,Unknown,"Pneumonia, Jan. 2, 2021","hypertension, congestive heart failure",,Unknown,"['COVID-19', 'Cardiac failure congestive', 'Chills', 'Confusional state', 'Decreased appetite', 'Dyspnoea', 'Fatigue', 'Lethargy', 'Pneumonia', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,UN 1080405,MO,26.0,F,"100 degree fever, headaches and intermittent nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,UNK,None,None,Heart murmur,"Flu vaccine chills, headache, body aches",Vicodin,"['Headache', 'Nausea', 'Pyrexia']",1,JANSSEN, 1080408,TX,38.0,F,Slight nausea about 4 hours after dose Fever with chills about 8 hours after dose. Very thirsty. Lasted 12 hours General unwell feeling from about 12 to 36 hours after dose,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,None,None,None,,None,"['Chills', 'Malaise', 'Nausea', 'Pyrexia', 'Thirst']",1,JANSSEN,IM 1080410,MD,29.0,F,"I received my shot at 3:30 pm on Friday 3/5/21. Around 9 pm I started experiencing extreme body aches all over that felt like my body was ""fighting"" against itself. I also experienced chills. I had a hard time sleeping from the pain. The next morning a headache started and progressed into a migraine. I could not get up or open my eyes from how bad the migraine was. I took extra strength Tylenol for the pain with little relief. On Saturday evening the symptoms started to get better and turned more into a headache. I still had the headache on Sunday but it was better after taking the Tylenol. On Monday my arm is now sore (it wasn't sore prior).",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/05/2021,03/05/2021,0.0,PUB,Gianvi oral birth control,,,,,"['Chills', 'Feeling abnormal', 'Headache', 'Migraine', 'Pain', 'Pain in extremity', 'Sleep disorder']",UNK,JANSSEN,SYR 1080414,OH,64.0,M,Difficulty breathing High level anxiety Chills then sweats,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PHM,Isosorbide mononitrate Synthroid Centrum Silver,None,Bad back -I have a spinal stimulator Under active thryoid Heart disease,,None,"['Anxiety', 'Chills', 'Dyspnoea', 'Hyperhidrosis']",1,JANSSEN,SYR 1080416,TX,56.0,F,"High fever, chills, sweating , thirst. Lasted 3 hours and subsided after taking tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PHM,Linisinopril,None,None,,None,"['Chills', 'Hyperhidrosis', 'Pyrexia', 'Thirst']",UNK,JANSSEN, 1080419,CT,63.0,M,101fever Chills Severe headache Vomiting,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,SCH,Atorvastatin Losartan,None,None,,None,"['Chills', 'Headache', 'Pyrexia']",1,JANSSEN,SYR 1080420,SC,40.0,F,"Chills, Cold Sweat, Nausea, Headache, Body Aches, Body/Skin burning, Thirst",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PHM,,,,,,"['Burning sensation', 'Chills', 'Feeling cold', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pain', 'Skin burning sensation', 'Thirst']",1,JANSSEN,SYR 1080457,CT,28.0,F,"Approximately 8 hours later, sudden onset of extreme chills accompanied by aches and fatigue; subsided after taking Tylenol. Next day, approximately 24 hours of fatigue, minor aches, headache, and fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,"Synthroid, liothyronine, escitalopram, buproprion, Gianvi, cetirizine, multivitamin",,"Autoimmune thyroiditis (Hashimoto), anxiety",,,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",UNK,JANSSEN, 1080459,NJ,44.0,F,"At 11pm I started feeling chills and was having cold sweats. Around 1 am I went to the next room to check my temperature and almost fainted. I sat on the floor and started vomiting. I kept gagging nonstop for several minutes. During that time I urinated on myself, I felt strong stomach aches, headache, and my body felt extremely fatigued. I was dizzy and sweating. All these symptoms came back again a few minutes later. I do not remember how long everything lasted. I woke up the next day with a slightly upset stomach and headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,"Paxil, 20mg/day, vitamins",none,low blood pressure,,no,"['Abdominal pain upper', 'Chills', 'Dizziness', 'Fatigue', 'Feeling cold', 'Headache', 'Hyperhidrosis', 'Retching', 'Urinary incontinence', 'Vomiting']",1,JANSSEN,SYR 1080462,IL,36.0,M,"Severe chills and shaking, fever ranging from 99-101.7 F, muscle aches, joint aches, headache lasting from 1 am - 11 pm 3/6 (day after injection). Acetaminophen every 8 hours, beginning at 3 am; ibuprofen every 8 hours beginning at 4 pm. Felt some general weakness on Sunday.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/06/2021,1.0,OTH,None,None,Smoking,,Sulfa,"['Arthralgia', 'Asthenia', 'Chills', 'Headache', 'Myalgia', 'Pyrexia', 'Tremor']",1,JANSSEN,IM 1080463,FL,23.0,M,"A few hours after I got the shot I had flu-like symptoms. Headache, fever, nausea, chills, and vomiting. About 12 hours later my flu-like symptoms went away but my headache turned into a migraine. I have no history of migraines. I have been taking ibuprofen and tylenol but it has not been working. I currently still have the Migraine 48 hours after the shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,OTH,,,,,,"['Chills', 'Headache', 'Influenza like illness', 'Migraine', 'Nausea', 'Pyrexia', 'Vomiting']",1,JANSSEN,SYR 1080464,SD,58.0,F,"Tingling started at fingertips felt it go thru my whole body to my toes. Severe headache, fever, chills, body/joint aches",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/07/2021,0.0,PHM,Blood pressure med & high cholesterol med,None,None,,"Penicillin, oxycodone","['Arthralgia', 'Chills', 'Headache', 'Pain', 'Paraesthesia', 'Pyrexia']",1,JANSSEN,SYR 1080476,NC,55.0,F,"Day of shot Chills, shivering, muscle aches (back, neck), headache Next day - muscle aches and headache, fatigue- responded to Tylenol and Ibuprofen Following day - shoulder and neck aches; chest tightness- using albuterol",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,SCH,"Advair 250/50 2x/day, Flonase 50 mg 2x/day, lexapro 10 mg, wellbutrin 150mg, letrozole 2.5 mg, trazodone 100 mg, Zyrtec, sodium ducosate, calcium",None,"Asthma, outdoor allergies",,None,"['Arthralgia', 'Back pain', 'Chest discomfort', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Neck pain']",UNK,JANSSEN,IM 1080479,VA,35.0,F,"Chills, pressure headache, body aches, low grade temp",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,,,,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1080481,PA,60.0,F,"Had normal reaction to covid shot,fever,body aches and fatigue. Jan 29 dizzy and unable to focus, no appointments available with pcp, went to urgent care and sent to er for possible stroke, stroke ruled out and sent to physical therapy for vertigo then not spinning and regaining balance. Feb 17 vertigo returned on right and left sides, treated. Feb 19 left sided vertigo treated,Feb 22 left sided vertigo treated, March 1 right sided vertigo treated, March 5 negative for vertigo but still dizzy and off balance, vestibular exercises required to regain balance.. Positive for covid in July.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,01/07/2021,01/08/2021,1.0,UNK,"Multi vitamin, hair skin nail vitamin, levothyroxine 150mcg",No,No,,No,"['Balance disorder', 'Dizziness', 'Fatigue', 'Pain', 'Pyrexia', 'Vertigo', 'Vision blurred']",1,MODERNA,IM 1080484,CT,46.0,F,8:00 p.m. symptoms came on suddenly; sore arm (still sore - three days now) low grade fever(two days) uncontrollable shivers body aches headache (two days) fatigue (two days) heart racing,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,"Zyrtec, chlorthalidone, carvedilol, omeprazole",none,none,,"percocet, penicillin","['Chills', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Palpitations', 'Pyrexia']",UNK,JANSSEN,SYR 1080485,VA,75.0,M,Within 10 minutes of my dad receiving his COVID-19 vaccine he suffered a major stroke.,Not Reported,,Yes,Yes,6.0,Yes,N,02/04/2021,02/04/2021,0.0,PVT,,,,,,['Cerebrovascular accident'],1,MODERNA,SYR 1080491,DC,28.0,F,"Vomiting, nausea, body aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/07/2021,1.0,OTH,Lexapro Myrbetriq Singulair Amethia,None,OAB Anxiety Asthma,,None,"['Fatigue', 'Nausea', 'Pain', 'Vomiting']",1,JANSSEN,IM 1080493,,23.0,M,"Day 1: Chills, full body aches and cramps, headache, loss of apatite, nausea, dizziness, fatigue. Day 2: Full body aches, headache, loss of appetite, fatigue, dizziness. Day 3: Fatigue, Localized aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,MIL,,,,"Anthrax Vaccine, similar symptoms but they were much worse with Anthrax. Unknown date, age: 22 or 23",,"['Chills', 'Decreased appetite', 'Dizziness', 'Fatigue', 'Headache', 'Muscle spasms', 'Nausea', 'Pain']",1,JANSSEN,SYR 1080503,IN,56.0,F,"Started with chills at 8 pm on 03/06/21 that lasted until 4 pm on 03/07/21 even with staying in bed underneath two comforters. Temp got up to 102.3 at 230 pm on 03/07/21. Was alternating Tylenol with Advil every 4 hours starting at 8 pm 03/06/21. Fever finally broke, temp down to 99 around 830 pm with sweats that resulted in a bed linen change. Temp at 7 am on 03/08/21 was 99.1.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,"atorvastatin 20 mg, hydrochlorothiazide-triamterene 25mg-37.5mg, metoprolol Succinate ER 100 mg. Vit E, Vit B",None,"HTN, high cholesterol",,Codeine,"['Chills', 'Hyperhidrosis', 'Pyrexia']",1,JANSSEN,IM 1080510,MD,51.0,F,"1st dose, nausea, fever, aches 24 hours after vaccine. 2nd dose, numbness to left side of head and arm 1 week after vaccine",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/04/2021,02/12/2021,8.0,PVT,,,,,,"['Blood test', 'CSF myelin basic protein increased', 'Central nervous system lesion', 'Hypoaesthesia', 'Lumbar puncture abnormal', 'Magnetic resonance imaging head abnormal', 'Magnetic resonance imaging spinal abnormal', 'Nausea', 'Pain', 'Pyrexia', 'Scan with contrast abnormal', 'Spinal cord disorder']",1,MODERNA,SYR 1080517,MD,59.0,M,"Severe chills, sweating, low grade fever, intense headache, and pain in the back of my neck. Vaccination was at 10am and symptoms started at 7pm and lasted through the night. By 9am (23 hours later) all symptoms seem to be cleared leaving me very tired from lack of sleep.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,"Warfarin, Metoprolol, Paroxetine, Bupropion",None,None,,Declomycin,"['Chills', 'Fatigue', 'Headache', 'Neck pain', 'Pyrexia', 'Sleep disorder']",UNK,JANSSEN, 1080519,NC,39.0,F,"Headache, vomiting, body aches, muscle spasms, sweating, chills, extreme fatigue cannot stay awake more than an hour all started about 7 hours after vaccine and are continuing still... almost 48 hrs post vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/06/2021,0.0,UNK,,,Fibromyalgia,,,"['Fatigue', 'Headache', 'Hyperhidrosis', 'Muscle spasms', 'Pain', 'Somnolence', 'Vomiting']",1,JANSSEN,IM 1080523,MN,79.0,F,Patient developed redness and discomfort in her right eye a few days after the vaccine and within a week had lost all vision in the eye from an aggressive infectious versus inflammatory response. She was cultured for infection and everything came back negative. She was treated initially with antibiotics and anti-viral medication and did not start to improve until was started on frequent topical and oral steroids. She has still lost most of her vision but the inflammation is improving within the anterior chamber but her cornea is still opacified. She has a history of shingles that affected this eye but it had been quiet and she does not seem to be responding to anti viral medication.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/12/2021,02/17/2021,5.0,PVT,"Albuterol, Amlodipine, Atorvastatin, Lisinopril, duloxetine, Lassie, hydroxyzine, zebra, Xarelto, Symbicort",,"Hypertension, COPD, history of shingles",,NKDA,"['Blindness unilateral', 'Corneal opacity', 'Culture negative', 'Infection', 'Inflammation', 'Ocular discomfort', 'Ocular hyperaemia']",UNK,MODERNA,IM 1080528,NY,26.0,M,"Fever, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/07/2021,03/08/2021,1.0,PUB,None,None,Obesity,,None,"['Myalgia', 'Pyrexia']",1,JANSSEN,IM 1080531,,27.0,F,"Janssen COVID-19 Vaccine EUA Severe headache, body aches, fatigue for more than 24 hours after vaccine. Feels debilitating. Symptoms barely changed after taking 2 Advil pills.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,OTH,,,,,,"['Asthenia', 'Fatigue', 'Headache', 'Pain']",1,JANSSEN,SYR 1080538,KS,56.0,F,Unexpected Death. No details known at this time.,Yes,03/07/2021,Not Reported,Not Reported,,Not Reported,N,01/08/2021,03/07/2021,58.0,PVT,None known,none known,none known,,None reported,['Death'],UNK,PFIZER\BIONTECH, 1080542,LA,84.0,M,"Early afternoon of date of administration complained of tiredness and went to bed. The next day at about 6PM I received a call that he was confused and non responsive in bed, EMS called and he was transported to ER. Admitting diagnosis at admit was Delirium. He remained inpatient at Hospital from 2/24/2021 and transferred to Hospice on 3/6/2021. His condition deteriorated while hospitalized. Transfer diagnosis was Dementia, A-Fib and Diabetes.",Not Reported,,Yes,Yes,10.0,Yes,N,02/23/2021,02/24/2021,1.0,PHM,"Persantine, Neurontin, Finesteride, Perhaps others",Unknown,"T2 DM - controlled, A- Fib: Controlled, BPH,",,"Pcn, EES, Most antibiotics","['Atrial fibrillation', 'Condition aggravated', 'Confusional state', 'Delirium', 'Dementia', 'Diabetes mellitus', 'Fatigue', 'Unresponsive to stimuli']",2,MODERNA,IM 1080559,CO,47.0,F,"Low grade fever (100), achiness, head ache, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,PUB,DoTera Vitality pack vitamins & DoTera Digest,None,Chronic high risk hpv,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1080560,VA,48.0,F,"Severe flu-like symptoms, including chills, ache, and headache Metallic taste in mouth Injection site swelling and pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,"Xarelto, 10mg",allergies (seasonal),Melanoma,,"allergic to feathers, severe reaction to some fish toxins","['Chills', 'Dysgeusia', 'Headache', 'Influenza like illness', 'Injection site pain', 'Injection site swelling', 'Pain']",1,JANSSEN,SYR 1080572,NY,64.0,F,"Janssen COVID-19 Vaccine EUA Uncontrollable Shakes, fever spiking between 100 and 104, throwing up, pounding headache, aches throughout body",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/07/2021,03/07/2021,0.0,OTH,Anastrozole 1mg Omeprazole 20 mg,No,No,"Shingles - not as severe, flu like symptoms",No,"['Headache', 'Pain', 'Pyrexia', 'Tremor', 'Vomiting']",1,JANSSEN,IM 1080605,NJ,40.0,M,"Fever 101F, extreme fatigue, weakness, aches, dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,PHM,None,None,None,Flu shot 10/10/2020 - fever for 1 day,None,"['Asthenia', 'Dizziness', 'Fatigue', 'Pain', 'Pyrexia']",UNK,JANSSEN,SYR 1080608,CO,37.0,F,"I started getting fatigued and achy around 5 pm. By 6 pm I started to feel chilled and a fever began to form. By 6:30 or so I was shaking intensely and my fever was climbing quickly. By 8 pm I had a fever of 102.7 F. I took two Advil around 7 pm. My fever stayed that high for less than an hour, but it stayed at around 101.5 throughout the night. When I wok up at 6:30 it was still over 101. It took until early afternoon to go all the way back down to my normal temperature of 97.6 (that has been my normal temperature throughout the pandemic). I had a pounding headache throughout the night (with a fever) and for most of the next day. Today, on the 3/8, I will have some joint and muscle achiness. The most intense aching was in my hips and low back. FYI, I am marking that I have recovered from my adverse reaction in the field below because I am considering the high fever and intense headache and bod aches to have been the adverse reaction. My mild aching right now would not have been worth reporting.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,none,none,none,"I have, but I got three vaccines at once ( I was traveling out of the country) and it was almost two decades ago. I don't rememb",Sulfa,"['Arthralgia', 'Back pain', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pain', 'Pyrexia', 'Tremor']",1,JANSSEN,IM 1080620,VA,70.0,M,"Information provided by facility director. Resident told medical provider on 3/3/21 at routine visit that he had not felt right since receiving vaccine on 2/11/21. No specific complaints and no findings reported by provider. No specific complaints reported prior to nurse at facility finding resident unresponsive and breathing at approximately 6AM on 3/5/21. 911 initiated. EMS, police and coroner responded.",Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/05/2021,1.0,SEN,"Iron, Lamctal 100mg,Olanzapine 10mg,Omeprazole; Spiriva inhal Tums, OTC; Advair 250 inhaler; Aspirin 81mg; Docusate Sodium 100mg; Ergocalciferol 125mg on Friday; Fluoxetine hcl 40 mg; Haloperiodol 10mg; Hydrochlorothiazide 25mg. Medication",None reported,schizophrenia,,None reported,"['Death', 'Feeling abnormal', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,IM 1080622,IN,55.0,F,Fever 102 Aches Nerve pain throughout body Weakness Nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,OTH,"Thyroid meds, Valtrex, low dose naltraxone",Upper respiratory,Hashimotos,,Soy,"['Asthenia', 'Nausea', 'Neuralgia', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1080623,OH,29.0,F,"Fever, headache, body ache, tiredness All started at 8:10 am the day after I received the vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/08/2021,1.0,PHM,"Effexor, Suboxone",None,None,,Penicillin,"['Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1080626,TN,70.0,F,"Pt with h/o myasthenia gravis presents to ED with 3 week h/o worsening weakness. Unclear exact timing on onset relative to vaccine administration but appears to have been a few days later. During these 3 weeks, patient also diagnosed and treated for a UTI but patient had worsening of weakness leading to falls x2 a few days before presenting to hospital ED. On admission to hospital, pt diagnosed with myasthenic crisis treated initially with non-invasive mechanical ventilation and plasmapheresis. DDx included UTI with encephalopathy and confusion related to it.",Not Reported,,Not Reported,Yes,13.0,Not Reported,,01/29/2021,02/01/2021,3.0,UNK,"Venlafaxine, metformin, losartan, cetirizine, atorvastatin, APAP-oxycodone, amitriptyline, amlodipine Potentially: pyridostigmine",,"Myasthenia gravis, hypertension, type 2 diabetes mellitus, pernicious anemia",,Azithromycin (unclear reaction),"['Asthenia', 'Blood glucose increased', 'Blood lactic acid', 'Blood pH decreased', 'Chest X-ray normal', 'Computerised tomogram head normal', 'Condition aggravated', 'Confusional state', 'Encephalopathy', 'Fall', 'Mechanical ventilation', 'Myasthenia gravis crisis', 'PCO2 increased', 'Plasmapheresis', 'Respiratory failure', 'Troponin increased', 'Urinary tract infection', 'White blood cell count increased']",1,MODERNA,IM 1080627,DE,69.0,F,"Johnson and Johnson Janssen COVID-19 EUA vaccine At the time of the injection, the vaccine burned as it entered my arm. (I have never felt that burning sensation with any other vaccination that I have had in the past. Twenty minutes after the vaccination, I became lightheaded and dizzy. I could walk but I was wobbly. At one hour after the vaccination, I felt a sharp stabbing pain in the left side of my tongue and then the left side and only the left side of my tongue began to go numb. Within a couple of minutes, I realized that my left jaw was going numb, too. The numbness slowly but surely began to move up the left side of my face all the way to the top of my head. I had a sharp but brief headache on the left side of my head that subsided quickly but the numbness remained. I went home and talked to two people on the phone for several hours because they wanted to be sure that I was OK. At two hours after the vaccination, my face was still numb but I could think and talk clearly, but I was clearing my throat and coughing a lot. At that point, I also realized that my whole left arm was a little numb and my fingers on my left hand were tingling. That numbness lasted about 20 minutes and then subsided. The facial numbness lasted for hours. I wasn't scared and I wasn't in pain but it was very strange. It felt a little bit like the after affects of dental anesthesia but it wasn't just in my mouth it was the whole left side of my face. I believe that this must have been an allergic reaction to one of the chemicals in the vaccine but I don't know which one. If you can tell me which chemical it might have been, I will avoid it in the future.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,SCH,(1) Diphenhydramine HCl 25mg tablet (taken at 8pm the night before my vaccination),none,none,cortisone injected into knee; 58 years old; My knee felt like it had been injected with shards of glass. The pain was hot and,"Azithromycin, Sulfadiazine, Omnicef, Cefdinir, Clonidine, Cipro, Asprin, Prozac, Lisinopril, Amlodipine, HCLZ, Cortisone, Red wine, Red grapes, Red pepper, MSG, Caffeine, Poison ivy (acute systemic reaction) holly and pine (evergreen rash)","['Balance disorder', 'Burning sensation', 'Cough', 'Dizziness', 'Feeling abnormal', 'Glossodynia', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Injection site pain', 'Paraesthesia', 'Throat clearing']",1,JANSSEN,IM 1080634,IL,49.0,M,"""Janssen COVID-19 Vaccine EUA"" Joint pain, including shoulders, hips knees and ankles. Chills. Sweating during sleep. Low grade fever. General body aches. Symptoms began approx 12 hours after dose was given and still persist approx 36 hours later. No doctor or hospital visit is required at this time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,SCH,Losartan,,,,,"['Arthralgia', 'Chills', 'Night sweats', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1080636,TX,45.0,F,"Severe pain, fever, hallucinations, dizziness, spasms loss of balance lasting until now ( 3/8)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,UNK,Blood pressure medication,None,High blood pressure,Flu,None,"['Balance disorder', 'Dizziness', 'Hallucination', 'Muscle spasms', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1080666,,17.0,F,"Patients under the age of 18 Inadvertently given their series of Moderna vaccine; A spontaneous report was received from a nurse concerning a 17-years-old female patient who received Moderna's (mRNA-1273) COVID-19 Vaccine. The patient's medical history was not provided. No concomitant medications were provided. The patient received her first of two planned doses of mRNA-1273 (Lot/batch number: 012L20A) on 15 Jan 2021. On 15 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot/batch number: 010M20A) for prophylaxis of COVID-19 infection. The patient under the age of 18 Inadvertently was given her series of Moderna vaccine (inappropriate age at vaccine administration). The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The outcome of the event the patient under the age of 18 Inadvertently given their series of Moderna vaccine was considered recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 012L20A for her first dose and lot number 010M20A for her second dose) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/15/2021,01/15/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Product administered to patient of inappropriate age'],2,MODERNA,OT 1080667,AZ,65.0,M,"chest cold; Bad sinus; Sore from head to toe; A spontaneous report was received from a consumer concerning a 65-Year-old, male patient was participating in the mRNA-1273 Emergency Use Program and experienced bad sinus, chest cold and had felt sore from head to toe. The patient reporter included no information about allergies, historical or current conditions. No relevant concomitant medications were reported. On 18 Feb 2021, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 20 Feb 2021, the patient experienced Lower Respiratory Tract Infection (chest cold), Sinus Disorder (bad sinus) and Pain (sore from head to toe). The seriousness criteria for these event is considered to be Medically important. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/20/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Lower respiratory tract infection', 'Pain', 'Sinus disorder']",1,MODERNA,OT 1080668,MD,,F,"Terrible headache; Feet are swollen from knee all the day down to her foot; Blood pressure shot up to 189 when she got the second shot; A spontaneous report was received from a consumer concerning 82 year old, female patient who developed feet are swollen from knee all the day down to foot, blood pressure shot up to 189. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received the second of two planned doses of mRNA-1273 (Batch number:030L20A) on 17 Feb 2021 intramuscularly in the left arm deltoid for prophylaxis of COVID-19 infection. On the same day the patient experienced terrible headache. Approximately after one day she developed swollen knee and blood pressure 189. The event high blood pressure 189 was considered as medically significant. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the events was not applicable. The outcome of the all events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/17/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no relevant medical history reported),,,"['Blood pressure increased', 'Blood pressure measurement', 'Headache', 'Peripheral swelling']",2,MODERNA,OT 1080669,PA,,M,"Speech was affected; he could not speak; Face was drooping; fever; A spontaneous report was received from a consumer concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced speech was affected; he could not speak, Face was drooping, and fever. The patient's medical history was not provided. No concomitant medications were provided. On 25-Feb-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) via an unknown route for prophylaxis of COVID-19 infection. On the same day, 25-Feb-2021, the patient experienced speech was affected; he could not speak, face was drooping, and fever. At the beginning, his speech was affected but by the time he went to the emergency room, he could not speak. No treatment information was provided. Action taken with mRNA-1273 with respect to the events was not reported. The outcome of the reported events was unknown. The reporter did not provide a causality assessment for the events.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,U,02/25/2021,02/25/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Aphasia', 'Facial paralysis', 'Pyrexia']",2,MODERNA,OT 1080671,FL,74.0,M,"Patient received vaccine 1/26/2021, complained of fever and chills post vaccine. Daughter reported worsening symptoms to confusion, decreased appetite, N/V and chest pain. Dry cough and SOB. Patient admitted to facility for Chest pain, AMS on 2/2/2021. Expired 2/2/2021.",Yes,02/02/2021,Not Reported,Not Reported,,Not Reported,,01/26/2021,02/02/2021,7.0,UNK,,,,,NKA,"['Chest pain', 'Chills', 'Confusional state', 'Cough', 'Death', 'Decreased appetite', 'Dyspnoea', 'Mental status changes', 'Nausea', 'Pyrexia', 'Vomiting']",UNK,MODERNA, 1080675,MA,69.0,F,"About 6 1/2 hours after receiving the vaccine, I began to feel really cold and began to have uncontrollable shivering and shaking for 4 hours straight. A heating pad helped but continued after removing it. I also had a slight stomach ache. The next day, I felt i had less energy than normal, lethargic.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,"Aspirin, calcium supplements, Crestor, latanoprost, multi vitamin",,,,Hazel nuts,"['Abdominal pain upper', 'Asthenia', 'Chills', 'Feeling cold', 'Lethargy', 'Tremor']",UNK,JANSSEN,IM 1080684,NY,57.0,F,"Fever, chills, headache, muscle and joint aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,PUB,"Omeprazole, Hydrochlorothiazide",,Hypertension,1967 measles vaccine,"Codiene, Demerol","['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",UNK,JANSSEN,SYR 1080706,CO,53.0,F,"Severe chills, for an hour and a half starting at 10:30pm. Headache and severe tiredness. Injection site very minimal pain/soreness. Stiff neck.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/01/2021,03/07/2021,6.0,PVT,None,None,None,,"Sulfa, upset stomach only","['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Musculoskeletal stiffness']",1,JANSSEN,IM 1080710,TX,29.0,F,Syncope episode with convulsions Underwent cardiovascular and brain scanning and imaging Treated with Keppra x 3 days Determined to be a non-seizure event,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/12/2021,03/04/2021,20.0,PVT,Spironolactone (50mg) Lexapro (10mg) Nexplanon implant,,Low blood pressure Arachnoid cyst,,,"['Computerised tomogram head', 'Computerised tomogram thorax', 'Echocardiogram', 'Electroencephalogram', 'Magnetic resonance imaging', 'Syncope', 'Vascular imaging']",2,MODERNA,SYR 1080712,CT,62.0,F,"fever, headache, muscle aches, and feeling tired for 15 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PVT,Vitamin D 2- 1.25MG - once a week Ibandronate Sodium - 150 MG - once a month,none,None,,Sulfa,"['Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,JANSSEN, 1080716,MI,67.0,F,"On day three after vaccine administration patient expired. quite an active man, no signs led up to his death until maybe a half hour prior to the event.",Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,N,02/27/2021,03/01/2021,2.0,PVT,amLODIPine (NORVASC) 5 mg tablet meloxicam (MOBIC) 15 mg tablet metoprolol succinate (TOPROL XL) 100 mg 24 hr tablet valsartan-hydrochlorothiazide (DIOVAN-HCT) 320-25 mg per tablet,none,Arthritis Hyperlipidemia Hypertension,,none,['Death'],1,PFIZER\BIONTECH,IM 1080738,VA,61.0,F,"Friday , March 5 - Received shot at approx. 9:30am. 10:00 am feeling very tired. By 3:00pm feeling achy and feverish, 6pm full chills, headache, and fever and very achy. At 7:00pm took my temp. It was 100.4 degrees. I took 3 -200mg Advil and went to bed. Saturday, March 6 - woke at 6:30am feeling washed out. By 8:00am was feeling a bit achy, took 3- 200mg Advil and by 10:00am was feeling much better. Symptoms were completely gone by noon and have not recurred since.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PVT,"diuretic, low dose aspirin",none,Allergies High blood pressure,,Cipro All sulpha drugs,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",,JANSSEN,SYR 1080742,TX,65.0,M,6 days after the shot I thought I had a sinus infection. I received a steroid shot and z pak prescription on the morning of February 18. Was still feeling bad and checked myself into a local ER February 22 where I was diagnosed with congestive heart failure. Never had heart issues. I was in the hospital 6 days. I feel much better and now worried about getting second shot.,Not Reported,,Not Reported,Yes,6.0,Not Reported,U,02/12/2021,02/18/2021,6.0,PVT,Amlodipine 5MG BP Atorvastatin 40MG COL Carbinoxamin 4 MG Montelukast 10MG Bayer 81MG,,,,,"['Blood test', 'Cardiac assistance device user', 'Cardiac failure congestive', 'Chest X-ray', 'Echocardiogram', 'Electrocardiogram', 'Feeling abnormal', 'Sinusitis']",1,PFIZER\BIONTECH,SYR 1080751,TX,62.0,F,High blood pressure; chest pain; back pain; numbness in limbs; nausea and vomiting.; inability to walk or move legs and feet. Was officially diagnosed on 2/5/2021 wit Acute Sensory Axonal Neuropathy a severe/rare case of Guillain-Barre Syndrome. Unknown time for recovery. Is in the process of being referred to a rehab center.,Not Reported,,Not Reported,Yes,12.0,Yes,N,02/24/2021,02/25/2021,1.0,PUB,Amoxicillin 875mg; Hydrochlorothiazide 25mg; Hydrocodone 7.5mg; Letrozole 2.5mg; Losartan Potassium 50mg; Potassium Chloride 20 Meq; Raloxifene Hcl 60mg; Tizanidine Hcl 4mg All daily except hydrocodone and tizanidine,Bronchitis,High Blood Pressure; Breast Cancer Survivor,,Unknown at this time,"['Acute motor-sensory axonal neuropathy', 'Back pain', 'Chest pain', 'Gait inability', 'Guillain-Barre syndrome', 'Hypertension', 'Hypoaesthesia', 'Musculoskeletal disorder', 'Nausea', 'Vomiting']",2,MODERNA,SYR 1080753,MA,67.0,F,Patient reports redness of left injection site and left breast crease.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/06/2021,2.0,PVT,,,,,,"['Erythema', 'Injection site erythema']",1,JANSSEN,IM 1080756,,40.0,M,"Loss of consciousness Client was said to have �passed out while sitting at the waiting area about 5 minutes after vaccination. He was brought to the First Aid area �on a wheelchair. Client was noted to having urinary incontinence immediately he arrived at the First Aid area. His head was repositioned and ice pack applied to his forehead and client �recuperated and started talking. Duration of witnessed episode lasted for 15 seconds . Patient claimed having similar episodes with last episode occurring 6 years ago while at work. Vital signs was taken, monitored for �additional 30 minutes and was driven home by his significant other. Vital signs recorded Temp: 96.9deg. F; BP: 102/62 MAP: 76; H.Rate: 78; Oxygen sat: 97%. �(Vasovagal syncope). Neurologic: Loss of consciousness (Comment: Patient had Vasovagal reaction with patient having urinary incontinence, lasting for 15 seconds 5 minutes after vaccination. Patient claimed having similar episodes 6 years ago. )",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/01/2021,03/04/2021,3.0,PUB,,,,,,"['Loss of consciousness', 'Syncope', 'Urinary incontinence']",1,JANSSEN, 1080769,VA,33.0,F,received vaccine on 1/6; developed shortness of breath/respiratory failure on 1/10. Hospitalized for several weeks with end diagnosis of Multiple Sclerosis (new diagnosis),Not Reported,,Not Reported,Not Reported,,Yes,N,01/06/2021,01/10/2021,4.0,WRK,unknown,non-known,non-known,,bleach,"['Dyspnoea', 'Multiple sclerosis', 'Respiratory failure']",1,MODERNA,IM 1080781,TX,62.0,F,"Heart rate over 100 bpm for 24 hours, dizziness, weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/06/2021,0.0,PUB,"Benicar, levothyroxine, pantoprazole",None,"Hypo-thyroid, mild hypertension",,"Morphine, Sudafed","['Asthenia', 'Dizziness']",UNK,JANSSEN, 1080784,IN,57.0,F,"Headache, fever, fatigue, nausea, site pain, lasted about 12 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PVT,Gabapentin Escitalopram Lisinopril,Fibromyalgia,Fibromyalgia,,Sulfa,"['Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pyrexia']",1,JANSSEN,IM 1080786,IL,43.0,M,"I HAD MY YEARLY PHYSICAL ON NOVEMBER 20, MY PSA WAS 0.84. NO ISSUES WITH MY PROSTATE, OR NEVER HAD ANY ISSUES. ON 2/3/2021, i DEVELOPED A SEVERE PROSTATE INFECTION WAS TAKEN TO THE EMERGENCY ROOM. MY PSA WENT UP TO 39 AND MY WBC WAS 23,000. IT NOW AT 14, BUT STILL GIVING ME ISSUES. THE ONLY THING THAT CHANGED IN MY LIFE WAS I GOT THE COVID VACCINE FROM MODERNA.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/08/2021,02/03/2021,26.0,PHM,NONE,NONE,NONE,,NONE,"['Prostate infection', 'Prostatic specific antigen increased', 'White blood cell count increased']",1,MODERNA,IM 1080806,CO,60.0,F,"headache started at approx 3pm, debilitating chills with uncontrolled shaking started at 4pm with low grade fever that began to climb. Fever peaked at 104.8 and stayed there for approx 6 hours. Vomiting started around 7pm. Rapid hear rate for approx 4 hours. Pulse was over 120 beats for approx 2 hours with chest pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,OTH,Hyzentra Premarin Synthroid Crestor Finasteride Dialtizam Levasen,None,Common Variable Immune Deficiency Syndrome,,Imatrex,"['Chest pain', 'Chills', 'Headache', 'Heart rate increased', 'Pyrexia', 'Vomiting']",1,JANSSEN,IM 1080813,MN,65.0,F,"Starting about 5 hours after injection, fatigue, followed by extreme headache, followed by chills and aches. Lasting about 24 hours, treated with extra strength tylenol. I couldn't sleep due to the chills, and muscle aches during the night so I slept most of the next day until late afternoon. Kept taking Tylenol through the day and evening. Felt ok the following day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PUB,"Losartan 50mg, Venlafaxine 150 mg, D3 1000 iu 25 mcg, Pravastatin 20mg",none,"depression, high blood pressure, high cholesteral",,none,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pain', 'Sleep disorder', 'Somnolence']",1,JANSSEN,IM 1080821,MN,65.0,M,Slight dizziness and mild nausea occurring the day following the immunization (3/5) and continuing through present. No treatment as of yet has been administered.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/05/2021,1.0,PVT,"Naproxen 250 mg tablet, aspirin 81 mg, metoprolol tartrate 25 mg tablet, atorvastatin 40 mg tablet, tamsulosin 0.4 mg 24 hr capsule.",,Heart Condition.,,,"['Dizziness', 'Nausea']",1,JANSSEN,IM 1080843,IL,51.0,M,"Lanssen COVID-19 Vaccine EUA Headaches, muscle aches and fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,WRK,"multivitamin, fish, flax, borage oil and Lisinopril",none,none,,none,"['Headache', 'Myalgia', 'Pyrexia']",UNK,JANSSEN, 1080851,IA,38.0,F,"Received vaccine Thursday afternoon. Waited for a half hour after receiving the vaccine, as there is a history of anaphylaxis. On the drive home lips began to swell and the lips felt numb. Patient went home and took some Benadryl which seemed to help. Friday 3/5 Patient woke and her arm was swollen at the injection site and was very painful. Patient also complained of a headache at that time. Later that same day, Patient developed a rash at the injection site and intense itching all over her body including her face. Patient went to the Medical Center ER. At ER the staff evaluated her and administered IV steroids and Benadryl and sent her home with instructions to return in worsens. Saturday Patient complained that her throat began swelling and so she went back to the ER. The ER gave more IV steroids and Benadryl, a breathing treatment (nebulizer), and gave 2 doses of epinephrine. Due to Patient's continued symptoms and gradual worsening condition the medical provider at ER felt it necessary for Patient to be admitted, however, due to the smaller size and limited resources at ER it was decided for Patient to be transported to Hospital. Patient has remained admitted at Hospital since then, and yesterday (Sunday) she required another dose of epinephrine due to tongue swelling. Patient reports that she is being given IV Benadryl and steroids, and she will not be discharged today. Today Patient is also reporting a burning sensation with urination.",Not Reported,,Yes,Yes,2.0,Not Reported,N,03/04/2021,03/04/2021,0.0,PUB,1 mg of estrogen,No,"No , past history (since resolved by surgery) of endometriosis.",,"Anaphylaxis to eggs Sulfa-hives/fever Other allergies: dust, corn dust, bean dust, trees, grass, dirt, mold, and peppers.","['Blood test', 'Dysuria', 'Headache', 'Hypoaesthesia oral', 'Injection site pain', 'Injection site rash', 'Injection site swelling', 'Lip swelling', 'Pharyngeal swelling', 'Pruritus']",2,MODERNA,IM 1080854,CO,51.0,F,"About 36 hours after injection I developed a painful golf ball size hard cellulitis. We drew a circle around it to track its spread. I am now 72 hours from time of vaccination and red site is larger and more painful. I also had a low fever last night (100) which is high for me, since cancer treatment I struggle to get a fever, just the side effects ( chills aches). I was also very fatigued yesterday morning and the day before.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/07/2021,2.0,PVT,"Aromasin, lisinoril, methlaphetnadate, Reglan, Vitamin D and Calcium supplement",None,"Gastroparesis and some neuropathy from side affects of cancer treatment . Recent stage 3, grade 3 breast cancer, but in remission.",,"Ceclor, Isovue","['Chills', 'Fatigue', 'Injection site cellulitis', 'Injection site erythema', 'Injection site induration', 'Injection site pain', 'Injection site swelling', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1080868,DC,27.0,M,"I got the shot at 5:30 pm. Starting early the next morning (around 3 or 4am), I began to experience intense fever and headache. I got up to get Advil and had a seizure. I have epilepsy, and had not missed a dose of my medication. My last seizure before this was 2 years ago. After recovering, taking Advil, taking a shower, and going back to sleep for about 4 more hours, I woke up feeling fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,Vimpat,,Epilepsy,,,"['Condition aggravated', 'Epilepsy', 'Headache', 'Pyrexia', 'Seizure']",1,JANSSEN,IM 1080877,CT,56.0,F,"Severe flu like symptoms, Chills, fever, rapid beathing, body aches, headache, fatique for 1.5 days",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,SCH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Influenza like illness', 'Pain', 'Pyrexia', 'Respiratory rate increased']",1,JANSSEN,SYR 1080891,NJ,38.0,F,Very rapid heartbeat and ringing in ears. Heartbeat was elevated for approximately 8 hours. It has come back periodically over the past 36 hours with ear ringing. Anxiety.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/06/2021,0.0,PHM,Allegra,No,Asthma,,No,"['Anxiety', 'Heart rate increased', 'Tinnitus']",UNK,JANSSEN, 1080892,LA,62.0,F,"Janssen COVID-19 Vaccine EUA - chills, extremely tired, low grade fever started about 12 hours after injection (only at night)- reporting this 42hrs later - Advil helped with fever and sleep helped with tiredness",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/07/2021,1.0,OTH,"Spironolactone 100mg, Levothyroxine 75mg, Topiramate 50mg, Pravastin 40mg, Triamcinolone Acetonide Cream Citracal, Vitamin D3, Fish Oil",,,,,"['Chills', 'Fatigue', 'Pyrexia']",1,JANSSEN,IM 1080893,NM,73.0,F,I had chills and muscle aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/01/2021,03/03/2021,2.0,OTH,"Levothyroxine, rouvastatin, lisinopril,",,,,,"['Chills', 'Myalgia']",UNK,JANSSEN, 1080906,OH,63.0,F,"Half hour after injection my throat felt tight and my OPPOSITE arm hurt. About 1:00 am I got so chilled I couldn't get warm, I did not take my temperature because my thermometer goes under my tongue and I was afraid I would break it cause my teeth were chattering so bad. The next day I felt very weak and nauseous. Then I discovered I had a rash at the top of my legs. My left breast was very sore I felt like someone punched me. Today is Monday and I still have diarrhea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,UNK,"Montelukast, Zyrtec, D3, Zinc",NONE,I have chemical asthma,,"Can't take pain medications allergic to i believe opioids. Regular allergies to grass, mold and some flowers. Allergies to oranges, tomatoes.","['Asthenia', 'Breast pain', 'Chills', 'Diarrhoea', 'Nausea', 'Pain in extremity', 'Rash', 'Throat tightness']",1,JANSSEN,SYR 1080925,TX,60.0,F,Experienced light headedness and felt shaky few minutes after receiving the vaccine. BP 142/70 O2 sat - 100%,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,Experienced light headedness and shaky few minutes after receiving the vaccine. NOTE: Last meal was at 7:00 pm 3/7/2021. BP 142/70,None,None,,Penicillin - rash,"['Blood glucose increased', 'Dizziness', 'Tremor']",,JANSSEN,IM 1080930,KY,64.0,M,"FEVER, CHILLS, HEADACE, FLU-LIKE SYMPTOMS FOR 18 HOURS AFTER VACCINATION",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PHM,,,,,,"['Chills', 'Headache', 'Influenza like illness', 'Pyrexia']",,JANSSEN,IM 1080932,KY,87.0,F,DIAGNOSED WITH COVID 1/21/21; RECIEVED BAMLANIVUBAM INFUSION; HOSPITAL ADMISSION 1/23/21 WITH ACUT RESPIRATORY FAILURE DUE TO COVID. INTUBATED X 10 DAYS,Yes,02/03/2021,Not Reported,Yes,10.0,Not Reported,N,01/12/2021,01/23/2021,11.0,PUB,,"HYPERTENSION, COPD, NON-SMALL CELL CANCER RIGHT LUNG",,,NKA,"['Acute respiratory failure', 'COVID-19', 'Endotracheal intubation']",1,MODERNA,IM 1080951,IL,21.0,F,"Janssen COVID-19 Vaccine EUA fever of over 101�F, dry cough, shortness of breath, chills, muscle aches, weakness, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,UNK,,,,,,"['Asthenia', 'Chills', 'Cough', 'Dyspnoea', 'Headache', 'Myalgia', 'Pyrexia']",1,JANSSEN,SYR 1080963,OH,60.0,F,"Eight hours after the shot, I quickly became very chilled with total body aches and pains and extremely tired. My mouth became very dry. This lasted most of the night. The next morning approaching 24 hours after the shot, the initial side effects were gone but I then had a headache and a bit of nausea. Again was extremely tired and pretty much rested all day. All side effects were gone the next day. I felt no need to call my healthcare provider and did not take any over the counter pain medication.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PHM,EyePromise multi-vitamin; Magnesium Citrate 250 mg; Viactiv Calcium plus D; Potassium Chloride ER 20MEQ,none,none,,Codeine,"['Chills', 'Dry mouth', 'Fatigue', 'Headache', 'Nausea', 'Pain']",,JANSSEN,IM 1080967,FL,66.0,F,Fever onset approx 4 hours and have had high grade and low grade fevers since. Taking tylenol every 4-6 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,OTH,"lisinopril 5mg, breo 100 mcg/25 mcg",none,Asthma/COPD,,none,['Pyrexia'],UNK,JANSSEN,SYR 1080968,NY,34.0,M,"Feel cold, head ache, body ache",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/07/2021,0.0,UNK,,,,,,"['Feeling cold', 'Headache', 'Pain']",1,JANSSEN,SYR 1080977,CO,61.0,F,Rapid heart rate for several hours (about 10). Bad headache which is now a sinus headache on the right side.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,UNK,"Symbicort, cranberry pill, vitamin D, multivitamin",None,Asthma,Tetnus,"Ampicillin, Spetra, Keflex, macrobid. Had a reaction (bad headache and fever) from tetnus shot 20+ years ago.","['Headache', 'Heart rate increased', 'Sinus headache']",UNK,JANSSEN,IM 1080980,FL,32.0,F,"Chills, sweating, loss of appetite Slept for about 10-11 hours cold sweats throughout out the night and lingering feeling afterwards",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/07/2021,0.0,PHM,Citalopram 20mg,,,,,"['Chills', 'Decreased appetite', 'Feeling cold', 'Night sweats']",1,JANSSEN,SYR 1080983,CA,44.0,M,"1 week following my vaccine I (1/21/21) started experiencing a clogged sensation in my right ear. My symptoms have continued to escalate. I have suffered from hearing loss, consistent dizziness/off balance, and blurred vision.",Not Reported,,Not Reported,Yes,3.0,Yes,N,01/15/2021,01/22/2021,7.0,PVT,Valtrex,,,,PCN,"['Audiogram', 'Balance disorder', 'Computerised tomogram', 'Deafness', 'Dizziness', 'Ear discomfort', 'Magnetic resonance imaging', 'Vision blurred', 'X-ray']",2,PFIZER\BIONTECH,SYR 1080993,VA,55.0,F,Severe shaking started at 11 PM and continued for over an hour. Including teeth shattering. Had a low grade fever also.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PHM,Omeprazole Vitamin D Atenolol Statin Multi Vitamin,none,none,,none,"['Chills', 'Pyrexia', 'Tremor']",1,JANSSEN,IM 1081002,IN,84.0,F,"About 11 hours later, severe weakness in muscles causing her to fall in her apartment. She was admitted to hospital, and had fever and cough which progressed to pneumonia. Event further weakened already weak kidney function. After a week in hospital was transferred to nursing home long term.",Not Reported,,Yes,Yes,7.0,Not Reported,U,02/19/2021,02/19/2021,0.0,PVT,"Primidone, pravastatin, eliquis, d3, fish oil, ferrous sulfate, omeprazole, amlodipine, allopurinol, lokelma, aranesp shots, nplate shots, spiriva, preservision, dupixent shots",,"CKD, end stage, Rheumatoid Arthritis, COPD, Essential Tremor, ITP, mild small vessel disease--age relayed brain atrophy",,"All shellfish, iodine, albuterol, morphine","['Chest X-ray', 'Cough', 'Fall', 'Muscular weakness', 'Pneumonia', 'Renal impairment']",UNK,PFIZER\BIONTECH, 1081009,NC,85.0,F,"there were no signs of adverse reaction at the time of injections and she waited 15 minutes at the site to watch for side effects. and none were evident or reported. We were notified that she passed away on Saturday, March 6.",Yes,03/06/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,PHM,"combivent Respimat, Januvia 100mg,Metformin 500mg, vitamin C 100mg,Ferrous Sulfate 325mg,Famotidine 20mg,Sertraline 50mg,Carvedilol 12.5mg,Oyster shell calcium 500mg,Gabapentin 300mg,furosemide 20mg,EC Aspirin 325mg,atorvastatin 40mg,clopid",Cancer,"diabetes, heart disease",,"tramadol, morphine products",['Death'],1,MODERNA,IM 1081024,PA,83.0,F,"visits on 2/16/20 positive for influenza B, admitted she has been having a productive cough of brown sputum, dyspnea, fever/chills, poor appetite, body aches since roughly 7-10 days ago which would be about the time of her 2ND COVID Vaccine. Also had visits on 2/23,3/01 for similar complaints. Tested negative for SARS COV-2 through PCR on 3/1/21. tested positive on 3/7/21 through PCR.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/06/2021,03/07/2021,29.0,OTH,,"visits on 2/16/20 positive for influenza B, admitted she has been having a productive cough of brown sputum, dyspnea, fever/chills, poor appetite, body aches since roughly 7-10 days ago which would be about the time of her 2ND COVID Vaccine. Also had visits on 2/23,3/01 for similar complaints. Tested negative for SARS COV-2 through PCR on 3/1/21.","CHF, hyperlipidemia, hypothyroidism, HTN,hypoxia, Chronic Afib",,,"['Chills', 'Decreased appetite', 'Dyspnoea', 'Influenza', 'Pain', 'Productive cough', 'Pyrexia', 'SARS-CoV-2 test positive', 'Sputum discoloured']",UNK,PFIZER\BIONTECH, 1081033,WY,88.0,F,"Patient expired 2 days after receiving the vaccination. Patient had other signs of deterioration over the course of the previous month with worsening edema and difficulty breathing. Unlikely to be related according to our assessments, but wanted to err on the side of caution.",Yes,02/25/2021,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/25/2021,3.0,SEN,"Acetaminophen 500 PO Q4hrs PRN, Furosemide 20 mg PO daily, Cranberry fruit extract 500 mg PO daily, Cod liver Oil 1 cap PO daily, Brimonidine 0.025% Eye drops, Artificial Tears, Milk of magnesia, guafenesin DM, Debrox otic, Nystatin Powder","Chronic respiratory failure with hypoxia, and edema.","Closed head injury without loss of consciousness, contusion, edema, chronic respiratory failure with hypoxia, subclinical hypothyroidism.",,"Levofloxacin, bee pollen, and NSAIDs","['Blood bicarbonate increased', 'Brain natriuretic peptide decreased', 'Brain natriuretic peptide normal', 'Carbon dioxide increased', 'Death', 'Dyspnoea', 'Oedema', 'White blood cell count normal']",2,MODERNA,IM 1081034,NY,60.0,F,"Extreme malaise, headache, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,UNK,Synthroid,None,None,,None,"['Chills', 'Headache', 'Malaise']",UNK,JANSSEN,IM 1081039,GA,65.0,M,Patient presented with acute onset of rapidly progressing ascending weakness and paralysis and associated decrease in sensation,Not Reported,,Yes,Yes,6.0,Not Reported,N,02/10/2021,03/02/2021,20.0,PVT,"He received radiation to the left temporal lobe x 5, which he completed on 2/24. On 2/26, he received his first immunotherapy treatment","recurrent malignant melanoma with metastasis to the brain. In late October, early November, he began having generalized weakness and ""shakiness."" Ultimately, he underwent MRI of his brain on 1/16/21 for the symptoms of weakness, and was found to have a small left temporal lobe lesion with vasogenic edema. He had MRI of the T and L spine, which showed enhancement of the ventral nerve roots just below the level of the conus bilaterally.","history of recurrent malignant melanoma with metastasis to the brain, Hyperlipidemia, Pityriasis rubra pilaris",,None,"['Asthenia', 'CSF cell count', 'CSF glucose increased', 'CSF lymphocyte count abnormal', 'CSF monocyte count increased', 'CSF protein increased', 'CSF red blood cell count positive', 'CSF white blood cell count positive', 'Intracranial mass', 'Lumbar puncture normal', 'Magnetic resonance imaging head abnormal', 'Magnetic resonance imaging spinal abnormal', 'Paralysis', 'Protein total increased', 'Radiculopathy', 'Scan with contrast abnormal', 'Sensory loss', 'Vasogenic cerebral oedema', 'White blood cell count decreased']",1,PFIZER\BIONTECH,IM 1081044,PA,69.0,F,Experienced severe chest pain Severe migraine Pain in neck and back. Took ambulance to hospital Blood pressure was extremely high,Not Reported,,Not Reported,Yes,4.0,Yes,N,02/26/2021,02/26/2021,0.0,SCH,"Sunatriptan azelastine 137 mcg (0.1 %) nasal spray brimonidine 0.15 % ophthalmic solution cyanocobalamin 1,000 mcg tablet ascorbic acid (vitamin C) 500 mg tablet Fish Oil 340-1,000 mg capsule",Steroid shot in both knees 2 days prior to Pfzer covid shot,Migraine,,Sulfa drugs Certain antibiotics,"['Back pain', 'Blood pressure increased', 'Cardiac stress test', 'Chest pain', 'Computerised tomogram', 'Electrocardiogram', 'Magnetic resonance imaging', 'Migraine', 'Neck pain']",1,PFIZER\BIONTECH,IM 1081050,NJ,42.0,F,"Approximately 6 hours after vaccine, I had a headache, chills and body aches. These continued all night and got better the next morning when I took Ibuprofen. On Sunday morning, a little less than 48 hours after vaccine, I notice certain parts of both arms were itchy. This morning, a little less than 72 hours after vaccine, I am experiencing an itchy rash in several places on my body including torso , knees and arms and legs.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,PVT,Mirena IUD,none,none,,none,"['Chills', 'Headache', 'Pain', 'Pruritus', 'Rash', 'Rash pruritic']",1,JANSSEN,IM 1081056,CA,28.0,M,"Fatigue, fever, minor nausea for over 24 hours. Vaccine occured Saturday at 11:30AM and beginning of symptoms were noticeable around 10 am the following day (Sunday).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PHM,None.,None.,None.,,None.,"['Fatigue', 'Nausea', 'Pyrexia']",1,JANSSEN, 1081060,CT,46.0,M,"Achy knees. sore arm, tired",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,UNK,None,None,None,,None,"['Arthralgia', 'Fatigue', 'Pain in extremity']",1,JANSSEN,SYR 1081063,CT,66.0,F,Pfizer shot on Sunday am - my father noticed my mother c/o not feeling well and unable to explain why she didn't feel well. She woke up feeling well and then quickly became disoriented and vomited. She was then unable to walk or communicate appropriately. Emergency services was called and she was transported to Emergency room. She was diagnosed with a posterior brain CVA and was treated with tpa and now remains hospitalized in the ICU with expressive aphasia and vision loss.,Not Reported,,Yes,Yes,,Yes,N,03/03/2021,03/07/2021,4.0,PUB,synthroid,family history of cardiac disease,hypothyroidism,,none,"['Angiogram', 'Aphasia', 'Blindness', 'Cerebrovascular accident', 'Computerised tomogram', 'Disorientation', 'Gait inability', 'Intensive care', 'Malaise', 'Vomiting']",1,PFIZER\BIONTECH,IM 1081067,CT,34.0,F,"Fever of 102, violent chills, aches, nausea fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,None.,None,None,,None.,"['Chills', 'Fatigue', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1081072,NY,53.0,F,None stated.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/08/2021,1.0,PVT,fever awful chills headache eyeballs hurting,none,none,,none,['Unevaluable event'],UNK,JANSSEN, 1081079,NY,43.0,F,Minor chills Muscle aches tightness Throbbing joint pain in multiple areas. Exacerbated in areas where I already have chronic joint/muscle pain Mid grade fever Severe headache All lasted for 36 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,"Probiotics, vitamin C, Valtrex",,"Ulcerative Colitis, Arthritis- neck, Tennis Elbow",,Sulpha,"['Arthralgia', 'Chills', 'Condition aggravated', 'Headache', 'Muscle tightness', 'Myalgia', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1081091,CT,39.0,F,"Fatigue, dizzy, nauseous",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PUB,none,none,none,,none,"['Dizziness', 'Fatigue', 'Nausea']",1,JANSSEN,SYR 1081096,MN,71.0,M,"Headache, joints hurt, no appetite, fever. Injection site painful",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,OTH,"Multi vitamin, Amlodipine, Spironolactone, Cyclobenzaprine, Carvedilol, Hydrochlorothiazide, Atorvastatin, D3 and 81mg asprin",None,"COPD, kidney disease, high blood pressure",,Penicillin,"['Arthralgia', 'Decreased appetite', 'Headache', 'Injection site pain', 'Pyrexia']",1,JANSSEN,IM 1081108,CA,72.0,F,"Cellulitis in left leg may be acting up/Might have an infection in area of cellulitis in left leg; Cellulitis in left leg may be acting up/Might have an infection in area of cellulitis in left leg; Questioned if she might have a blood clot in left leg; Might have an infection in area of cellulitis in left leg; pain in the left leg; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9262, expiration date 31May2021), via an unspecified route of administration on 01Feb2021 at left upper arm around 19:00 or a little later at single dose (at the age of 72-years-old) for covid-19 immunization. Medical history included bad knees and got injections for this and recurrent cellulitis of legs (cellulitis was not active at time of vaccine; but anytime her leg swells with bad knees she had a little episode with the cellulitis down around her ankles on both legs but left leg was more predominant. She had been keeping it at bay), mineral supplementation, bad knee pain, blood pressure medication (abnormal), urine output control (abnormal), dehydrated and dizzy. Concomitant medication included lisinopril as blood pressure medication, potassium for Mineral supplement, solifenacin succinate for urine output control, paracetamol (TYLENOL 4) for bad knee pain. She had taken potassium before and it calmed it down: she was little dehydrated, little dizzy, so was drinking some Pedialyte, water, and taking potassium. The patient had it once before but it kind of snuck up on her again. The patient called to ask if anyone had reported any type of blood clot on the same side of the body that the Pfizer COVID-19 Vaccine was administered. She questioned if she might have a blood clot in her left leg after having been administered the Pfizer COVID-19 Vaccine. She had recurrent cellulitis in both legs prior to Pfizer COVID-19 Vaccine. The doctor thought the cellulitis in left leg may be acting up and that she might have an infection in that area of cellulitis. She reported pain in the left leg when she rested her leg on a pillow; but did not feel any pain when she was standing and walking. The pain became a little too hard for her to bear so the doctor prescribed her Cephalexin 500m capsule every 12 hours-she was on the 3rd capsule now. Onset date for the events was approximately 03Feb2021 or 04Feb2021. The events were better since started Cephalexin. Second dose date scheduled for 22Feb2021 but did not give her time. The outcome of the events was recovering. Follow-up (23Feb2021): New information received from the product quality complaint group includes confirmation of lot number (EL9262) and new expiry date.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,UNK,LISINOPRIL; POTASSIUM; SOLIFENACIN SUCCINATE; TYLENOL,,Medical History/Concurrent Conditions: Blood pressure abnormal; Cellulitis of legs; Dehydration; Disease recurrence; Dizzy; Joint disorder; Knee pain; Mineral supplementation; Swelling of legs; Urine abnormal,,,"['Cellulitis', 'Disease recurrence', 'Localised infection', 'Pain in extremity', 'Thrombosis']",1,PFIZER\BIONTECH, 1081109,CT,50.0,F,"Started with chills. I was freezing for almost three hours. I could not get warm-with tons of blankets, heater, heat cranked up. Then I was seating. I had a fever and am still fighting this fever. It was at 103 on Sat. It was 101 this morning. I feel fluish-body aches, headache, eye sockets hurt, exhausted. On sat, after the chills, my legs hurt and felt like they were 100 pounds.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,OTH,Breo Pravastatin Dyamista,None,Asthma High cholesterol,,Seasonal E-mycin,"['Chills', 'Eye pain', 'Fatigue', 'Feeling cold', 'Headache', 'Influenza like illness', 'Limb discomfort', 'Pain', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,SYR 1081111,CT,50.0,F,"injection sight pain, fever, chills, body aches, exhaustion, migraine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,none,none,none,,penicillin,"['Chills', 'Fatigue', 'Injection site pain', 'Migraine', 'Pain', 'Pyrexia']",,JANSSEN,SYR 1081119,CO,56.0,F,"Starting 2:30 am, woke up nauseated, severe chills. Vomited 3am, severe chills, headache, body aches all night. Severe Body aches and headache lasted all next day. Leg aches became extreme next night. Following night, I still had chills, body aches, headache. Second morning, I am still having headache, moderate body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,PVT,Lisinopril,None,None,,None,"['Chills', 'Headache', 'Nausea', 'Pain', 'Vomiting']",1,JANSSEN, 1081122,CT,52.0,F,"Severe chills/uncontrollable shaking for 4 hours beginning 10 hours after the shot After chills ended - headache for 1 hour, body fatigue for 6 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,"Toviaz, Centrum, Estrovin",None,None,,None,"['Chills', 'Fatigue', 'Headache', 'Tremor']",1,JANSSEN,SYR 1081123,CT,32.0,F,"Fatigue, chills, fever, body aches, nausea. Lasted approximately 12 hours. Treated with advil, fluids, and rest. Onset of body aches and fever for second time about 36 hours after injection. Treated with advil.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,"Blisovi 24-FE, Levothyroxine 50 mcg, Escitalopram 10 mg",None,"Hypothyroidism, endometriosis",,None,"['Chills', 'Fatigue', 'Nausea', 'Pain', 'Pyrexia']",UNK,JANSSEN, 1081132,NJ,58.0,M,Severe thrombocytopenia approx. 10 days after vaccine administration.,Yes,03/07/2021,Not Reported,Yes,8.0,Not Reported,N,02/05/2021,02/26/2021,21.0,UNK,Aspirin Adult Low Dose 81 MG Tablet Delayed Release 1 tablet Orally Once a day Lisinopril 5 MG Tablet 1 tablet Orally Once a day Vitamin B12 1000 MCG Tablet Extended Release 1 tablet Orally Once a day Rosuvastatin Calcium 5 MG Tabl,,"Dyslipidemia, Hypertension, HIV+",,NKA,"['Platelet count decreased', 'Thrombocytopenia']",UNK,MODERNA,IM 1081133,CT,63.0,F,"Severe chills, body ,muscle, joint aches, fever and sweats. Some stomach cramping . These all lasted 7 hours. Next day still body aches, headache and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,"Multi vitamin, vitamin d3, fish oil, calcium,",None,None,,Penicillin,"['Abdominal pain upper', 'Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1081142,CT,58.0,F,"tired, slight headache (back of the neck area) lasted about 36 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,"Atorvastatin, 20 mg",,,,,"['Fatigue', 'Headache', 'Neck pain']",1,JANSSEN,SYR 1081144,NC,37.0,F,"Fever (100.2), lack of balance, body aches (mainly in legs), mild nausea, mild headache, brief period of incontinence, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,"Vitamin D, C, Sam E, Multivitamin, Birth control pills (Jolessa)",,Astha,,Gluten &. Topical Benzoid peroxide,"['Balance disorder', 'Fatigue', 'Headache', 'Incontinence', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1081146,CT,77.0,F,"lightheadedness/presyncope, palpitations, racing heart, premature ventricular contractions with bigeminy, atrial tachycardia, fever 101, chills, myalgias, arthralgias, headache, right arm pain",Not Reported,,Not Reported,Not Reported,,Yes,N,02/17/2021,02/18/2021,1.0,PUB,"Amlodipine, Aspirin, CoQ10, Dulera, Fish oil, HCTZ, Lisinopril, Loratadine, Lutein, Protonix, Simvastatin, Vit B12, C, D",Sore arm and arthalgias/myalgias from Covid vaccine #1 1/20/21,"HTN, hyperlipidemia, PVD, carotid disease, GERD",,"PCN, Ibuprofen, Procardia, Codeine","['Arthralgia', 'Atrial tachycardia', 'Chills', 'Dizziness', 'Echocardiogram', 'Electrocardiogram', 'Electrocardiogram ambulatory', 'Extrasystoles', 'Headache', 'Heart rate increased', 'Myalgia', 'Pain in extremity', 'Palpitations', 'Presyncope', 'Pyrexia', 'Ventricular extrasystoles']",2,MODERNA,IM 1081154,CT,44.0,F,"chills, fever, sweats, body aches, headache, injection site soreness - lasted about 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,Zoloft 150mg,none,none,,seasonal - pollen,"['Chills', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1081155,MT,86.0,F,Pt died on 3/6/2021. Received Vaccine on 2/12/2021. Unknown cause of death.,Yes,03/06/2021,Not Reported,Not Reported,,Not Reported,,02/12/2021,03/06/2021,22.0,PVT,,,,,,['Death'],UNK,MODERNA, 1081156,CT,33.0,M,"Headache, fever and fatigue. As for treatment Tylenol was used every 4 hours. Feeling better, headache is gone but still feel fatigue and the temperature seems to be under control.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/07/2021,1.0,PVT,No medications were taken at the time of the vaccination.,None,None,,None,"['Fatigue', 'Headache', 'Pyrexia']",1,JANSSEN,SYR 1081158,CT,48.0,F,"Chills, fever, achy legs, exhaustion",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,,,Automimmune disease,,,"['Chills', 'Fatigue', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,IM 1081160,CT,63.0,F,"Fever, chills, and vomiting the evening of the vaccine administration. Symptoms continued into the following evening. Fever broke early morning of 3/8/2021",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,"multi-vitamin, minoxidil, spirolactone...did not take day of vaccination",none,none,,Penicillin and sulfur drugs,"['Chills', 'Pyrexia', 'Vomiting']",1,JANSSEN, 1081161,VA,47.0,F,"Cardiac dysrhythmia, tachycardia, anaphylaxis",Not Reported,,Yes,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PVT,"Metoprolol, allegraD, Topamax, singulair.",,"High blood pressure, Migraines, Asthma, PCOS","Hives, cardiac dysrhythmia, tachycardia, sob","Zosyn, seasonal, Tree Pollen","['Anaphylactic reaction', 'Arrhythmia', 'Chest X-ray', 'Electrocardiogram', 'Full blood count', 'Metabolic function test', 'Myocardial necrosis marker', 'Tachycardia']",UNK,MODERNA, 1081167,VA,41.0,M,Woke up around 5:30AM having to go to the bathroom. Went to Flush the toilet and passed out on the floor. My wife found me unresponsive but breathing on the floor. My wife called 911 and was at the hospital around 6:15AM.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/06/2021,03/07/2021,1.0,PVT,"Men's One A Day Multivitamin, Metoprolol Tartrate 25 MG 2x a day, Ezetimibe 10 MG 1 a day around 8pm, Bayer Aspirin Low Dose 81 MG 1 a day, Atorvastatin Calcium 80MG 1 a day around 8pm.",,Heart Disease,,,"['Blood creatine phosphokinase', 'Blood magnesium', 'Blood thyroid stimulating hormone', 'Chest X-ray', 'Computerised tomogram head', 'Echocardiogram', 'Electrocardiogram', 'Full blood count', 'Hepatitis C antibody', 'Influenza A virus test', 'Influenza B virus test', 'Loss of consciousness', 'Metabolic function test', 'Respiratory syncytial virus test', 'SARS-CoV-2 test', 'Troponin', 'Troponin I', 'Unresponsive to stimuli']",1,JANSSEN,IM 1081172,CT,48.0,F,"fever, tiredness, achy joints, nausea/lack of appetite",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PVT,,,,,,"['Arthralgia', 'Decreased appetite', 'Fatigue', 'Nausea', 'Pyrexia']",1,JANSSEN,SYR 1081176,FL,34.0,M,"Within 12 hours of receiving the vaccine, around 2-3am, I began getting chills that lasted a couple of house. I had a temperature of 99.5 but immediately came down. In the early morning (the next day since receiving the vaccine), I felt nauseous followed by a headache. I also felt dizzy, but that immediately subsided. All of the mentioned side effects have subsided. My arm has been sore since receiving the vaccine but the pain has relatively minimized over time.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,UNK,Bupropion XL -150mg,,,,,"['Chills', 'Dizziness', 'Headache', 'Nausea', 'Pain in extremity']",1,JANSSEN,SYR 1081204,CT,66.0,M,Minor muscular pain throughout body most of the day. No treatment. Back to normal 2 days after receiving vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PVT,"Aspirin - 81 MG, Synthroid - 150 MCG, Benicar - 20MG, Lyrica X 4 - 50MG, Crestor - 5MG",None,"High blood pressure, hypothyroidism",,None,['Myalgia'],1,JANSSEN,IM 1081206,NY,32.0,F,"After receiving the vaccine at 9:30pm, I was awoken at approximately 4:30am that night/the next morning with an extremely high heart rate. After about thirty minutes, I was able to calm down and my pulse/heart rate dropped down to a level that still seemed elevated, but no longer caused a great deal of concern. This event was followed by nausea for the remainder of the day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PUB,None,None,None,,None,"['Heart rate increased', 'Nausea']",1,JANSSEN,SYR 1081210,MD,21.0,M,"About 9 hours after receiving the vaccine (around 2am) I had a fever, chills, headache, sore arm, and muscle soreness. I fell back asleep and when I woke up the fever had broken and the chills had improved but the soreness and headache remained. I took Tylenol in the afternoon and that helped the symptoms but by the time I had gone to bed the chills had returned but not a fever. When I woke up in the middle of the night (night 2) the chills had stopped and I woke up with a moderate headache and sweating profusely. After falling asleep and awaking in the morning I felt much better with the exception of a minor headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PHM,"Melatonin, Omega-3 Fish Oil, Centrum Men's 1 a day multi vitamin",,,,Penicillin (break out in hives),"['Chills', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,SYR 1081213,CA,32.0,F,"Severe Angioedema persisting, currently at 36 days after first dose.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/31/2021,02/01/2021,1.0,UNK,,,,,Penicillin,"['Anaphylactic shock', 'Angioedema']",1,PFIZER\BIONTECH,SYR 1081228,TX,37.0,F,"Body aches, joint pain, fatigue, chills, throbbing, starting at 6:30pm and continuing into the following day",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,OTH,Sertraline 75mg,None,None,,None,"['Arthralgia', 'Chills', 'Fatigue', 'Pain']",UNK,JANSSEN,SYR 1081231,MD,79.0,M,"Admitted to local hospital 2/24 with weakness, malaise, cough and altered mental status 2 days after receiving 2nd dose of moderna SARS COV2 vaccine. He was initially tachycardic, febrile and had leukocytosis 18K, with admission labs with creatinine 1.8, lactate 2.4. He had need for supplemental oxygen and was placed on broad spectrum antibiotic therapy. Respiratory viral panel including SARS COV2 PCR was neg. Blood cultures from 2/24, 2/27, 3/3 were negative. CT chest showed some prominent mediastinal adenopathy which was increased from prior CT 2017. Also had axillary and inguinal lymphadenopathy. 2/27 he had a code blue called for bradycardia in context of receiving ativan for a CT study. Antibiotics were changed to Vancomycin, ceftriaxone and ampicillin, acyclovir on 2/28. Multiple attempts by multiple providers at doing a lumbar puncture have been unsuccessful. Bronchoscopy 3/2 with left lower lobe secretions. Cultures negative. He has stayed incessantly febrile and working diagnosis is probable underlying lymphoproliferative neoplasm immunostimulated by vaccine. At this time a bone marrow and lymph node excisional biopsy is planned. Patient is unstable to proceed for MRI imaging at this time due to hypotension.",Not Reported,,Not Reported,Yes,13.0,Not Reported,N,01/25/2021,02/22/2021,28.0,PVT,cyclobenzaprine 5 MG tablet Take 1 tablet by mouth nightly as needed. ? dorzolamide-timolol (COSOPT) 22.3-6.8 MG/ML ophthalmic solution Place 1 drop into both eyes 2 times daily. ? hydrochlorothiazide 25 MG tablet Take 1 tablet by mouth dai,None documented,"Essential hypertension Peripheral vascular disease s/p femoral, to below-knee popliteal artery bypass 9/2019, RIGHT CAD Pharm Stress (9/24/19): EF 66%, small area of mild ischemia in LCx territory.On medical therapy History of SVT BPH Obstructive sleep apnea",,Oxycodone- hallucinations,"['Alanine aminotransferase normal', 'Aspartate aminotransferase increased', 'Asthenia', 'Bilirubin conjugated', 'Blood albumin decreased', 'Blood alkaline phosphatase increased', 'Blood bilirubin normal', 'Blood bilirubin unconjugated decreased', 'Blood creatinine increased', 'Blood culture negative', 'Blood lactic acid decreased', 'Blood urea increased', 'Bradycardia', 'Bronchoscopy abnormal', 'Candida infection', 'Cardio-respiratory arrest', 'Computerised tomogram thorax abnormal', 'Condition aggravated', 'Cough', 'Haemoglobin decreased', 'Hypotension', 'Leukocytosis', 'Lymphadenopathy', 'Lymphadenopathy mediastinal', 'Lymphocyte count decreased', 'Lymphoproliferative disorder', 'Malaise', 'Mental status changes', 'Monocyte count normal', 'Platelet count normal', 'Protein total decreased', 'Pyrexia', 'SARS-CoV-2 test negative', 'Sputum culture', 'Tachycardia', 'White blood cell count increased']",UNK,UNKNOWN MANUFACTURER, 1081235,TX,26.0,F,Patient complaint of fatigue/(sleepy) and sensitive to light immediately 15 minutes after getting Janssen & Janssen vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,OTH,None,None,None,,None,"['Fatigue', 'Photophobia', 'Somnolence']",1,JANSSEN,IM 1081238,CT,48.0,F,"Chills, fever, headache. Fever lasted until Monday, March 8th",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,"Lexapro, Lyrica, vitamin D, multivitamin",,,,Allergic to penicilian,"['Chills', 'Headache', 'Pyrexia']",UNK,JANSSEN, 1081243,CT,55.0,F,"Chills, fever (101.7) aches, sore arm, vomiting",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PUB,Prolia Myrbetriq,None,None,Shingles vaccine,None,"['Chills', 'Pain', 'Pain in extremity', 'Pyrexia', 'Vomiting']",UNK,JANSSEN, 1081245,VA,80.0,M,fatigue 6 hours no treatment,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,UNK,"caradopa levidopa, metaprolol, atorvastatin",,parkinsons,,,['Fatigue'],UNK,JANSSEN, 1081249,SC,28.0,F,Fever Night sweats Extreme chills and shaking Body aches Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,PHM,Allegra Mult vitamin Biotin D3,No,No,,No,"['Fatigue', 'Night sweats', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1081277,CA,75.0,M,"During the evening of his vaccination he started having chills with severe shaking associated with fever. Presented to ED on 2/28/21. Fever was 104F. Disoriented on presentation, CRP of 18, mildly elevated troponin, persistent hypotension, headache. Received fluids and Rocephin. Admitted to ICU 2/28/21. Discharged 3/1/21. Final Diagnosis- hyperpyrexia, hypotension, related to immunologic reaction from second Pfizer COVID vaccine. Cannot rule out septic shock from RLL pneumonia and pleural effusion. Hx of COVID 19 myocarditis, chronic systolic CHF and cardiomyopathy EF of 45%, with current mildly elevated troponin. Mild hyponatremia, lactic acidosis. Acute encephalopathy related to hyperpyrexia.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/27/2021,02/27/2021,0.0,PVT,,,,,,"['C-reactive protein increased', 'Chest X-ray abnormal', 'Chills', 'Computerised tomogram head abnormal', 'Computerised tomogram thorax abnormal', 'Disorientation', 'Ejection fraction decreased', 'Encephalopathy', 'Headache', 'Hyperpyrexia', 'Hyponatraemia', 'Hypotension', 'Intensive care', 'Lactic acidosis', 'Lung infiltration', 'Pleural effusion', 'Pneumonia', 'Pyrexia', 'Septic shock', 'Tremor', 'Troponin increased']",2,PFIZER\BIONTECH,IM 1081279,SD,90.0,M,"Patient seen by physician for weakness, tired, increase SOB, falls, increase confusion and then subsequently hospitalized . Patient then expired on 3/7/21.",Yes,03/07/2021,Not Reported,Yes,5.0,Not Reported,N,03/02/2021,03/02/2021,0.0,PVT,albuterol sulfate 90 mcg/actuation aerosol inhaler (ProAir HFA) 2 puffs inhalation 4H PRN albuterol sulfate 2.5 mg NEB TID atorvastatin 40 mg tablet 0.5 tabs PO DAILY budesonide 0.5 mg/2 mL suspension for nebulization 1 vial NEB BID carved,"Has underlying COPD, Was discharged from hospital 1/25/21 for pneumonia. Was declining prior to vaccination: more SOB, falling, abdomen bloated, coughing a little more, tired and weak.","COPD, CKD-3, CAD, Anemia, heart failure with reduced ejection fraction, a fib.",,"atenolol, simvastatin, terazosin","['Alanine aminotransferase normal', 'Albumin globulin ratio normal', 'Anion gap', 'Aspartate aminotransferase normal', 'Asthenia', 'Basophil count normal', 'Basophil percentage', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bilirubin normal', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine increased', 'Blood glucose normal', 'Blood magnesium normal', 'Blood potassium normal', 'Blood sodium increased', 'Blood urea increased', 'Blood urea nitrogen/creatinine ratio increased', 'Carbon dioxide increased', 'Chest X-ray abnormal', 'Confusional state', 'Death', 'Dyspnoea', 'Eosinophil count normal', 'Eosinophil percentage', 'Fall', 'Fatigue', 'Globulin', 'Glomerular filtration rate decreased', 'Haematocrit decreased', 'Haemoglobin decreased', 'Immature granulocyte count', 'Lung opacity', 'Lymphocyte count decreased', 'Lymphocyte percentage decreased', 'Mean cell haemoglobin concentration decreased', 'Mean cell haemoglobin increased', 'Mean cell volume increased', 'Mean platelet volume normal', 'Monocyte count increased', 'Monocyte percentage increased', 'Neutrophil count normal', 'Neutrophil percentage', 'Platelet count normal', 'Protein total decreased', 'Red blood cell count decreased', 'Red cell distribution width normal', 'White blood cell count normal']",2,MODERNA,SYR 1081286,PA,67.0,M,"evening of vaccination developed fatigue, sweats, palpitations and subsequent DOE and orthopnea that persisted and led to hospitalization 3/7/2021 for atrial fibrillation with rapid ventricular response and acute on chronic decompensated systolic CHF.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/27/2021,02/27/2021,0.0,PVT,1) ACETAMINOPHEN 500MG TAB TAKE ONE TABLET BY MOUTH ACTIVE THREE TIMES A DAY FOR PAIN/FEVER 2) AMIODARONE HCL (PACERONE) 200MG TAB TAKE ONE TABLET ACTIVE BY MOUTH DAILY FOR IRREGULAR HEARTBEAT 3) CARVEDILOL 25MG,no acute illnesses. Dose #2 The patient received Pfizer COVID-19 Vaccine 0.3 ml IM. MVX (Manuf); Lot#; Exp Date: PFR; EN6203; 06/30/2021 Administration Anatomic site: Right Deltoid,"chronic conditions include CAD, CHF w EF 35%, known A fib. all were well controlled at time of vaccination.",,dabigitran (diarrhea),"['Acute left ventricular failure', 'Atrial fibrillation', 'Brain natriuretic peptide increased', 'Cardiac failure acute', 'Cardiac failure congestive', 'Chronic left ventricular failure', 'Dyspnoea exertional', 'Electrocardiogram abnormal', 'Fatigue', 'Hyperhidrosis', 'Orthopnoea', 'Palpitations', 'Troponin']",2,PFIZER\BIONTECH,IM 1081295,CT,49.0,F,Sore arm at sight of injection Nausea Headache Body aches Weakness Panic attacks,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,Zoloft 200 mg Excedrin,None,Headaches Back pain IBS,,None,"['Asthenia', 'Headache', 'Injection site pain', 'Nausea', 'Pain', 'Panic attack']",1,JANSSEN,SYR 1081301,CT,27.0,F,"No adverse side effects until 10:00 PM- chills began, fever until 2:30 AM, fever broke, then whole body aches with intense headache, high level of fatigue- with advil and mucinex- symptoms subsided- unknown if they will return once medication wears off",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/07/2021,0.0,PVT,Triprevitem- oral contraceptive,None,None,"yearly flu vaccine, fatigue and arm pain at site of injection",Sulfa,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",UNK,JANSSEN, 1081304,,90.0,F,patient passed away within 60 days of receiving a COVID vaccine,Yes,03/07/2021,Not Reported,Not Reported,,Not Reported,,02/26/2021,03/07/2021,9.0,UNK,,,,,,['Death'],1,MODERNA, 1081305,NE,59.0,M,Sudden death approximately 24 hours after receiving 2nd COVID vaccine - symptoms unknown - autopsy revealed cardiac disease as the cause of death,Yes,02/27/2021,Not Reported,Not Reported,,Not Reported,N,02/26/2021,02/27/2021,1.0,MIL,,,Cardiac disease,,,"['Autopsy', 'Cardiac disorder', 'Sudden death']",2,MODERNA,IM 1081308,MI,71.0,M,"Death 3 days afterards, undetermined cause at this time.",Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/02/2021,03/02/2021,0.0,PUB,,none,none,,,"['Cardiac arrest', 'Death', 'Laboratory test normal']",2,PFIZER\BIONTECH,SYR 1081312,CT,48.0,F,"I got the COVID-19 vaccine on Saturday (janssen). I just wanted to let you know that I experience mid back pain after the covid vaccine was administer on my left arm. it felt like a sharp pain but only in my mid back area. by the evening i got chills and also a fever which i took tylenol, i felt nauseous, my head felt like it was not attached to my body, i havent sleep anything in 2 days. I had a severe migraine and also vomiting but most of all is the spinning of y head like when people have vertigo. I havent been able to eat food because it comes out both ways, either i vomit or constant diarrhea. i made a call to my doctor waiting for her response. this symptos started around 6pm on 03/06/21 and still until today 03/08/21",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PVT,none,none,none,,"codine, surgical tape and rayon clothing","['Back pain', 'Chills', 'Decreased appetite', 'Diarrhoea', 'Feeling abnormal', 'Migraine', 'Nausea', 'Pyrexia', 'Sleep disorder', 'Vertigo', 'Vomiting']",1,JANSSEN,JET 1081321,VA,33.0,F,"Around 3:00pm on 3/7/21 I began to feel a little tired. But 3:45pm I was experiencing muscle pain through my body at only continued to get worse. At 4:30pm I took 400mg of ibuprofen since sitting, walking, and lying down were all painful. Relief came around 5:30pm and I was able to nap for an hour. At 6:30pm I awoke and attempted to eat, as I was beginning to feel nauseous. At 8:30pm I laid down again, my symptoms returning and worsening. I was now experiencing chills with my muscle pain and a headache. Pain was located throughout my body and my skin was sensitive to the touch. At 10:30pm I began shaking violently and struggled to feel warm, despite my skill feeling hot. My temperature was not taken. Another 400mg of ibuprofen was taken and one 350mg chewable of Tums anti-acid was eaten. It was not until 12:30am that I was able to sleep again. The morning of 3/8/21 I was still fatigued and sore. Moving was difficult and painful and nausea was still present, and my headache returned. I was unable to eat despite trying. At 10:00am I took two tablets of Excedrin Migrain and napped for almost two hours. Currently, my muscle aches are minimal and my headache has improved. This may however be due to the medication.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,PVT,Children's Flintstone vitamin gummies - 2 chews once daily Viactiv: Calcium plus vitamin D - 1 chew once daily Lamotrigine 150mg - 1/2 tablet by mouth once daily,None,Asthma Bipolar Disorder Type 2 Depression Anxiety,,In 2017 I had a rash after four days of trying Trileptal. It was discontinued the same day.,"['Fatigue', 'Feeding disorder', 'Feeling cold', 'Headache', 'Mobility decreased', 'Myalgia', 'Nausea', 'Pain', 'Pain of skin', 'Skin warm', 'Tremor']",1,JANSSEN,IM 1081329,TX,84.0,M,Pt. homecare person came up and stated that he was sleepy and was not able to get out of bed. Was responding and eating and drinking well. Was told to go to the ER. To let us know. Finally reached pt. today. Said he was in and out of hospital for 3 weeks. Not feeling well since the shot. Is trying to get to a long term center,Not Reported,,Yes,Yes,21.0,Not Reported,N,02/09/2021,02/10/2021,1.0,PVT,Digoxin PRN Isosorbide Dinitrate 30mg QD Omeprazole 20mg QD Tramadol PRNI Finasteride 5 mg qd simvastatin 20MG qd cARVEDILOL 6.25mg 2 times a day Spiriva handihaler 18mcg BID Symbicort 160/4.5,None aware of.,BMI 31---31.9----osteoarthritis----Foot drop----Cervical Stenosis of spinal canal---Lumbar Radiculopathy---unsteady gait---HTN---BPH,,none.,"['Malaise', 'Mobility decreased', 'Somnolence']",1,MODERNA,IM 1081331,MI,70.0,F,"11.5 hours after vaccine I began to vomit and continued for 48 hours with dry heaves. Only drank water then vomited . Ate 1/2 cut of chicken soup and vomited it up. Constant chills. Back ached so bad I couldn't sleep first 24 hours. Still feel week 3 days later, however able to eat and drink with no nausea 1200 noon on 03/08/21. No health issues, no medications.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/05/2021,03/06/2021,1.0,UNK,0,0,0,,Penicillin,"['Asthenia', 'Back pain', 'Chills', 'Retching', 'Vomiting']",1,JANSSEN,SYR 1081412,KY,52.0,M,"Headache, body aches, chi.lls, fever, excessive tiredness, loss of appetite, injection site soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/01/2021,03/01/2021,0.0,PHM,,none,"diabetic, high blood, chf,",,none,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1081416,OK,74.0,F,"Pt. presented to ED via EMS for emergent coma. EMS intubated patient in field due to respiratory failure. Pt. was severely hypertensive with nearly total loss of brainstem reflexes. Patient had known L MCA cerebral aneurysm with appointment to undergo intervention to address in the near future. NCCT reported massive multifocal brain hemorrhage, SAH, SDH, and parenchymal hemmorhage with midline shift and subfalcine herniation. Due to dismal/poor prognosis, family requested withdrawal of support approximately 4 hours after presentation and patient expired shortly thereafter.",Yes,02/25/2021,Not Reported,Yes,1.0,Not Reported,N,02/22/2021,02/25/2021,3.0,PVT,Albuterol 90 mcg inhaler 2 puffs q6h prn SOB ASA 81 mg PO daily Excedrin Extra Strength 1 tab PO PRN Atenolol 100 mg PO daily Caltrate 600+D 1 tab PO daily Cetirizine 10 mg PO daily Cholecalciferol 2000 unit PO daily Dicyclomine 20 mg PO da,None,Known L MCA cerebral aneurysm HTN Hypothyroidism,,Benzocaine Codeine Penicillins Sulfa,"['Brain herniation', 'Cerebral haemorrhage', 'Cerebral mass effect', 'Coma', 'Death', 'Endotracheal intubation', 'Hypertension', 'Respiratory failure', 'Subarachnoid haemorrhage', 'Subdural haematoma']",1,PFIZER\BIONTECH,IM 1081427,CT,31.0,F,"Chills, muscle aches, low grade fever, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,Prozac,No,No,,None that I am aware of,"['Chills', 'Headache', 'Myalgia', 'Pyrexia']",1,JANSSEN,SYR 1081432,CT,43.0,F,"45 minutes after receiving vaccine, patient experienced numbness of her upper posterior palate and down her throat. This lasted about 4 hours and resolved without further treatment. No shortness of breath, rash or swelling noted per patient report.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PUB,"lexapro, biotine, MVI",none,obesity,,none,"['Hypoaesthesia oral', 'Pharyngeal hypoaesthesia']",1,JANSSEN,IM 1081442,IL,69.0,F,"pt states that she developed a bad headache next day after getting the vax. Pt was very confused, vomiting, and had brain fog so she called her son. She was getting worse and having spots, stars and flashes in front her eyes so he took her the OSF ER on 2/5/2021.They did a CT and blood work. Pt was admitted and assessed by a Neurologist and Physical Therapist. She was told she had altered mental status. She was stayed for 3 days and discharged. She stayed with her son for 6 days and then went to her PCP which told her not to return to work at this time. Pt will FU on 3/24/2021.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/04/2021,02/05/2021,1.0,PVT,"metformin, glipizide, atorvastatin, levothyroxine, aspirin 81mg, omeprazole, escitalopram,",no,"Diabetes, chlorestoral,",,unknown anti-inflammatory,"['Computerised tomogram', 'Confusional state', 'Feeling abnormal', 'Headache', 'Impaired work ability', 'Laboratory test', 'Mental status changes', 'SARS-CoV-2 test negative', 'Visual impairment', 'Vomiting']",2,MODERNA,IM 1081451,NJ,31.0,F,"Fever, chills, nausea, severe headache (still on-going), severe lower back pain (still on-going)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/05/2021,1.0,PHM,"Alprazolam 0.5mg, metoprolol succinate 25mg",,Asthma,"Gardasil (passed out immediately after receiving vaccine), aged 21","Ceclor, stadol","['Back pain', 'Blood test', 'Chills', 'Headache', 'Nausea', 'Pyrexia', 'Urine analysis']",UNK,JANSSEN, 1081471,MA,92.0,M,This individual received the first dose of the Covid-19 Pfizer vaccine on 3/4/21 and a few days later passed away on 03/07/21.,Yes,03/07/2021,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/07/2021,3.0,OTH,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1081489,,69.0,F,102 fever with accompanying muscle ache. Took two tylenol. Fever and ache gone by morning,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,UNK,none,none,none,,none,"['Myalgia', 'Pyrexia']",1,JANSSEN,IM 1081490,SC,75.0,M,"Received second vaccine on 2/3/21 and on 2/4/21 developed nausea, vomiting, chills and low grade fever. Presented to the emergency department on 2/7/21 due to refractory nausea and inability to tolerate PO intake. Denies symptoms of epistaxis, hemoptysis, bruising, petechiae, active signs of bleeding. Labs notable for AKI w/ CR of 1.7 (baseline CR 1.0) and cholestatic liver enzyme elevation (AST 144/ALT 237/ALP 295/T bili 6.1/direct bili 4.0) and thrombocytopenia (nadir to 13). Discharged on 2/13/21. Of note, he had 2 similar admissions in June 2018 and Oct 2019 with unrevealing workup of mixed liver injury. All 3 admissions were after some type of viral antigen exposure: June 2018 after shingles vaccine 2nd dose, Oct 2019 with sapovirus gastroenteritis, and current admission after COVID vaccine 2nd dose.",Not Reported,,Not Reported,Yes,6.0,Not Reported,,03/03/2021,03/04/2021,1.0,PVT,,,,,,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Bilirubin conjugated increased', 'Blood alkaline phosphatase increased', 'Blood bilirubin increased', 'Blood creatinine increased', 'Chills', 'Hypophagia', 'Liver function test increased', 'Nausea', 'Pyrexia', 'Thrombocytopenia', 'Vomiting']",2,PFIZER\BIONTECH,IM 1081509,NY,30.0,F,"Head aches, fever, fatigue, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,UNK,"Montelukast, albuterol, ozempex",,"Asthma, diabetes",Flu shot,"Ceclor, seafood, shellfish, nuts","['Chills', 'Fatigue', 'Headache', 'Pyrexia']",1,JANSSEN,SYR 1081513,NE,39.0,F,"Sore arm immediately. Fatigue, headache, chills and sweats started the next day and into day 3 after the vaccine was received.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,SCH,"Spironolactone 100 mg/day, Loratadine 20 mg/day",None,None,,Tramadol,"['Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Immediate post-injection reaction', 'Pain in extremity']",1,JANSSEN,IM 1081518,,33.0,M,"Body aches and fatigue that evening, around 6pm. Symptoms still present next morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,OTH,none,none,none,,none,"['Fatigue', 'Pain']",1,JANSSEN,IM 1081521,CT,33.0,F,"Chills, Injection site soreness, fatigue, (possible fever) did not record temperature, dizziness and headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PVT,,,,,,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Injection site pain']",1,JANSSEN,SYR 1081525,KS,69.0,M,"Woke up at 2AM and was not able to breathe. Tongue and throat were swelling, heart was racing, crawled to front room to call 911. Was dizzy, weak, throat and tongue were swelling.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/25/2021,02/26/2021,1.0,PUB,Aleve and ibuprofen. Duloxetine Dexilant Magnesium Furosemide Iron Tradjenta Aspirin Atorvastatin Metroprolol Metformin Tamsuloxin Fish Oil Levemir Novolog,No,Heart Disease Diabetic,,Garlic Crestor Bactrim Metoglooranmide,"['Asthenia', 'Blood test normal', 'Dizziness', 'Dyspnoea', 'Dysstasia', 'Laboratory test normal', 'Palpitations', 'Pharyngeal swelling', 'Swollen tongue', 'Ultrasound scan normal']",1,MODERNA,IM 1081529,CT,56.0,F,horrendous headache. lasted the night of injection and 1/2 the following day. no treatment.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,SCH,,,,,penicillin,['Headache'],1,JANSSEN,IM 1081532,GA,37.0,F,"01/29/2021 Fatigue, soreness at injection site. Pt took OTC Tylenol/Advil. 02/18/2021 Epigastric pain, dyspnea, nausea, vomiting. Pt took OTC Tylenol/Advil and went to Dr. office because pt thought she had gallbladder pain/concern. 02/20/2021 Pt went to ED: tested negative for Covid-19 virus but found to have elevated liver enzymes. Pt remained at hospital inpatient status until 02/24/2021. Pt states she was never given any diagnoses/causes for symptoms. 03/05/2021 Pt went to her PCP, and blood labs obtained; pt continues to have elevated liver enzymes per pt's report.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,01/29/2021,02/18/2021,20.0,PVT,"Tylenol, Advil",None,Obese (undiagnosed),,None,"['Abdominal pain upper', 'Biliary colic', 'Dyspnoea', 'Fatigue', 'Hepatic enzyme increased', 'Injection site pain', 'Nausea', 'SARS-CoV-2 test negative', 'Vomiting']",2,PFIZER\BIONTECH,IM 1081546,CT,41.0,F,"fever, chills, aches, lethargic, shortness of breath",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/06/2021,0.0,PUB,,,,,,"['Chills', 'Dyspnoea', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1081547,MS,84.0,M,"NO IMMEDIATE ADVERSE EVENTS PRESENT FOLLOWING IMMUNIZATION. RESIDENT WAS ALERT, RESPONSIVE, TALKATIVE, WITHOUT COMPLAINTS, AND ENGAGING IN NORMAL ACTIVITIES AFTER IMMUNIZATION, AS WELL AS THE FOLLOWING DAY. HE WAS FOUND IN BED THE SECOND MORNING AFTER VACCINATION (AT 6:25AM) WITHOUT VITAL SIGNS AND HAD EXPIRED PEACEFULLY IN HIS SLEEP. HE WAS A DNR, NO LIFE SUSTAINING MEASURES WERE PERFORMED.",Yes,03/07/2021,Not Reported,Not Reported,,Not Reported,U,03/05/2021,03/07/2021,2.0,OTH,"LIQUID PROTEIN, PRILOSEC, LACTOBACILLUS, ELIQUIS",NONE,"A-FIB, PERIPHERAL VASCULAR DISEASE, HERNIA REPAIR WITH BOWEL RESECTION JANUARY 2021",,NONE,['Death'],2,MODERNA,IM 1081549,CA,71.0,M,"A few days after the first shot I was working outside as golf marshall about 5 pm. Tip of middle finger became painful and numb feeling. Outside temp was about 58 degrees F. Two days later numbness spread to adjoining index and ring fingers. They became very painful and sensitive to touch. Visits to primary care doctor, hand specialist and vascular surgeon is pointing to circulation problem. Finger tip continue to be extremely painful with no relief. Large black areas have formed on two fingers and is spreading to my right hand",Not Reported,,Not Reported,Not Reported,,Yes,N,01/22/2021,01/24/2021,2.0,PVT,Ramapril 5mg Atorvastatin 80 mg Testosterone gel 1.6%,None,Non Hodgkin's Lymphoma,,Shrimp sometimes,"['Hypoaesthesia', 'Pain in extremity', 'Poor peripheral circulation', 'Skin discolouration', 'Tenderness', 'Ultrasound Doppler']",1,PFIZER\BIONTECH,SYR 1081561,CT,28.0,F,"Headache, chills, nausea, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,PVT,,,,,,"['Chills', 'Fatigue', 'Headache', 'Nausea']",UNK,JANSSEN,SYR 1081576,VA,51.0,F,"Got J&J vaccine Sunday and have experienced every side effect listed. Had 103 degree fever, took tylenol, drank water. Fever broke @ 4am, still have excruciating headache, eyes hurt from the light, body aches, can't move right arm more than 90 degrees . Fever is now at 2pm 3/8 inching up, is 99.5.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,UNK,"Magnesium, Vitamin D, zinc, Vitamin C",N/a,N/a,Flu,"Allergic to mollusks, ragweed, dog","['Headache', 'Mobility decreased', 'Pain', 'Photophobia', 'Pyrexia']",UNK,JANSSEN,SYR 1081604,NJ,65.0,M,"Possible PEA arrest unclear etiology ~1 hour after receiving first dose COVID-19 moderna vaccine, s/p ROSC in field after 3 minutes CPR, no meds given. Intubated in field, extubated after 2 days.",Not Reported,,Yes,Yes,5.0,Not Reported,Y,03/03/2021,03/03/2021,0.0,PVT,"Amlodipine-Atorvastatin, calcifediol, caRVEDILOl, doxazosin, febuxostat, lisinopriL",No known illnesses,"HTN, HLD, DM2, CVA with no residual deficits",,NKDA,"['Agonal respiration', 'Blood creatinine increased', 'Blood pressure increased', 'Chest X-ray abnormal', 'Condition aggravated', 'Diastolic dysfunction', 'Echocardiogram', 'Electrocardiogram T wave abnormal', 'Endotracheal intubation', 'Hypertension', 'Intensive care', 'Left ventricular hypertrophy', 'Mechanical ventilation', 'Pulmonary hypertension', 'Pulmonary oedema', 'Pulse absent', 'Pulseless electrical activity', 'Respiratory failure', 'Resuscitation', 'Troponin increased']",1,MODERNA, 1081606,CT,60.0,F,"Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Fainting / Unresponsive-Medium",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/08/2021,1.0,PHM,,,,,,"['Dyspnoea', 'Injection site pain', 'Syncope', 'Unresponsive to stimuli']",1,JANSSEN,IM 1081607,IN,52.0,F,"Fatigue, back and muscle pain, low grade fever, chills, teeth chatter",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,OTH,Multi vitamin Lexapro Probiotic,None,Post covid long haul symptoms. Tight chest and lungs.,,None,"['Back pain', 'Chills', 'Fatigue', 'Myalgia', 'Pyrexia']",1,JANSSEN,SYR 1081616,RI,36.0,F,"Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/07/2021,0.0,PHM,,,,,,"['Confusional state', 'Dizziness', 'Dyspnoea', 'Flushing', 'Hyperhidrosis', 'Hyperventilation']",1,JANSSEN,IM 1081618,IA,16.0,F,"No adverse events reported, was instructed to complete VAERS form due to age 16 at time of vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PUB,unknown,none,none,,none,"['No adverse event', 'Product administered to patient of inappropriate age']",1,JANSSEN,IM 1081621,TX,35.0,M,Symptoms included: Body aches Fatigue Chills Fever Headache Nausea Some diarrhea (mostly clear liquid) Runny nose clear Some congestion Difficulty breathing - arrhythmia from 11pm to 4am night after vaccine administered,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,UNK,None,None,Arrhythmia,,None,"['Arrhythmia', 'Chills', 'Diarrhoea', 'Dyspnoea', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Respiratory tract congestion', 'Rhinorrhoea']",1,JANSSEN,SYR 1081625,MN,64.0,F,"Patient seemed to pass out. Reported fear of needles. Happened about 13 minutes after vaccine was administered. She wasn't responsive to voice for short time period with a blank stare. Once she snapped out of it, she jerked and then we tried to make her more comfortable. EMS was contacted to verify patient was okay. Patient did not want to go to hospital or ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,Unknown.,Diverticulitis.,,,Unknown.,"['Dyskinesia', 'Fear of injection', 'Loss of consciousness', 'Staring', 'Unresponsive to stimuli']",1,JANSSEN,IM 1081627,TX,72.0,F,"Acute ITP (idiopathic thrombocytopenic purpura). Presented to clinic with diffuse purpura and petechiae. Platelets critical at 33,000.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/24/2021,02/25/2021,1.0,OTH,none,none,"hyperlipidemia, vitamin D deficiency",,none,"['Immune thrombocytopenia', 'Petechiae', 'Platelet count decreased', 'Purpura']",1,MODERNA,IM 1081735,AZ,,F,"Afib issues; Heart rate would increase and decrease; Feeling really tired; woke up really dizzy; A spontaneous report was received from a Consumer concerning herself, a 68- year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, afib issues, heart rate would increase and decrease, feeling really tired, and severe dizziness like vertigo, The patient's medical history, as provided by the reporter included, Afib and underwent surgery on 13 Jan 2021 for Afib issues. Concomitant products were not reported. On 19 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection. On 19 Feb 2021, it was reported that the patient experienced the events, Afib issues, heart rate would increase and decrease, went to bed feeling really tired and woke up with severe dizziness like vertigo, heart was down in the 40s and then spike up to the 80s. The patient was concerned that vaccine may have triggered Afib. On 19 Feb 2021, the lab test performed included heart rate 40s, heart rate 80s. No treatment information was provided. Action taken with mRNA-1273 in response to the event(s) was unknown. The outcome of events, Afib issues, heart rate would increase and decrease, feeling really tired and severe dizziness was unknown.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the start date of the events and excluding all other etiologies, a causal relationship with the events cannot be excluded. However, causality for Afib issues is confounded by the patient concurrent history of Afib. Fatigue is consistent with the known safety profile of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,UNK,,AFib,Medical History/Concurrent Conditions: Surgery (Surgery to repair Afib issue.),,,"['Atrial fibrillation', 'Dizziness', 'Fatigue', 'Heart rate', 'Heart rate abnormal']",1,MODERNA,OT 1081736,,,M,"redness on his bicep that looked like a tourniquet; arm was heavy; his lymph nodes were the size of grapes on his arm, underarm, bicep, neck and chest; areas were hot to touch; pain level was a 10, like his arm was going to explode; chills; Flu like symptoms; Just wanted to sleep; A spontaneous report was received from a consumer concerning a male of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness on his bicep that looked like a tourniquet/vaccination site streaking, arm was heavy/limb discomfort, lymph nodes were the size of grapes on arm, underarm, bicep, neck and chest/lymphadenopathy, areas were hot to the touch/vaccination site warmth, pain level at a ten, felt like arm was going to explode/pain in extremity, chills, flu-like symptoms/influenza like illness and just wanted to sleep/fatigue. The patient's medical history included cellulitis and swelling with mosquito bite. Concomitant product history was not provided. On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number:026L20a) for prophylaxis of COVID-19 infection. Two weeks after his first injection he had a small red circle the size of a half dollar at the injection site that lasted about three to four days. He notified his doctor and was told there was no issue with the red circle. On 17 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number:039K20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 17 Feb 2021 about 14 hours after his second shot he stated that he had flu like symptoms including chills, slept and had a sore arm. Then about a day and a half later in his left arm where he got the shot, his lymph nodes were the size of grapes on his arm, under his arm, bicep area, on the left side of his neck, and on the left side of his chest. The patient stated that the areas where hot to the touch and his pain level was at a 10. He felt like his arm was going to explode. He also just wanted to sleep. His doctor thought it was cellulitis. On 20Feb2021, the patient went to urgent care because he developed redness on his bicep that wrapped around his arm like a tourniquet, and his arm was really heavy. The urgent care doctor put him on steroids. On 21Feb2021, he contacted his doctor again and was told to go to the ER. He was taken off the steroid and but on IV vancomycin every 12 hours for 3 days. He was admitted to the hospital from the ER. The patient had 2 Covid tests while in the hospital and both came back negative. His white blood cell count was 35,000 while in the hospital and was seen by an infectious disease doctor. The patient was discharged on 23 Feb 2021. Treatments of these events included doxycycline, IV vancomycin Action taken with mRNA-1273 in response to the event were not applicable. The outcome of the event(s) were not provided.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/20/2021,02/18/2021,29.0,UNK,,,Medical History/Concurrent Conditions: Allergy (Swelling with mosquito bite); Cellulitis,,,"['Chills', 'Fatigue', 'Influenza like illness', 'Limb discomfort', 'Lymphadenopathy', 'Pain in extremity', 'Vaccination site streaking', 'Vaccination site warmth']",2,MODERNA,OT 1081737,TX,,F,"allergies turned to bronchitis with mucus; A spontaneous report (United States) was received from a consumer on 25-FEB-2021 concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a medically significant event of allergic bronchitis (reported as allergies turned to bronchitis with mucous). The patient's medical history included asthma and allergy. Relevant concomitant medications were not provided. On an unspecified date, the patient received Moderna COVID-19 Vaccine for COVID-19 vaccination. Tomorrow it�s being 5 weeks since her first shot. Some later, the patient developed allergies turned to bronchitis with mucus which started 3 or 4 weeks ago. She is going to receive her second shot the following week and will like not to miss it. Treatment of the event included antibiotics and steroids. Action taken with mRNA-1273 in response to the events was not reported. The events, allergies turned to bronchitis was considered not recovered/not resolved at the time of reporting.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,Allergy (Started as allergies and after the shot it turned to bronchitis with mucus.); Asthma,,,,['Allergic bronchitis'],1,MODERNA,OT 1081738,NY,,F,"Lung cancer; A spontaneous report was received from a consumer concerning her mother, a female patient, who was diagnosed with lung cancer/lung neoplasm malignant. The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter. On unknown date , the patient received their first of their two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, post-vaccination, the patient was diagnosed with lung cancer. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event, lung cancer, was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Lung neoplasm malignant'],1,MODERNA,OT 1081739,,75.0,F,"Fainting; Aches; Extreme Nausea; Chills; A spontaneous report was received from a consumer, concerning a 75-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme nausea, chills, aches and fainting. The patient's medical history, as provided by the reporter, included COVID-19 infection on last March. Concomitant medications reported included atorvastatin and levothyroxine sodium. On 20Feb2021, approximately 4 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch nmber:015M20A) for prophylaxis of COVID-19 infection. On 20Feb2021, the patient experienced extreme nausea, chills, aches and fainting. Treatment for events included ondansetron and paracetamol. Action taken with mRNA-1273 in response to the events were unknown. The outcome of the events, extreme nausea, chills, aches were considered recovering/resolving. The outcome of the event, fainting, was considered recovered/resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/20/2021,0.0,UNK,ATORVASTATIN; THYROXINE,,Medical History/Concurrent Conditions: COVID-19,,,"['Chills', 'Nausea', 'Pain', 'Syncope']",1,MODERNA,OT 1081740,CA,,F,"Paralyzed from the waist down for a few minutes and fell down; Feels disoriented; Sometimes can't even stand up; A spontaneous report () was received from a physician concerning a 77-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was paralyzed from the waist down and fell down/paralysis, feels disoriented/disorientation and sometimes can't even stand up/dysstasia. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included poly vitamins. On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 015M20A) intramuscularly for prophylaxis of COVID-19 infection. On 10 Feb 2021, approximately a few hours post vaccination, the patient experienced paralysis from the waist down for approximately 15 minutes which made her fall down. This event occurred two times. The patient stated she felt disoriented and could not stand up. Treatment information was not provided. The outcome of the events, was paralyzed from the waist down and fell down/paralysis, feels disoriented/disorientation and sometimes can't even stand up/dysstasia, were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Yes,U,02/10/2021,02/10/2021,0.0,UNK,POLY VITAMIN,,Medical History/Concurrent Conditions: No adverse event (No prior medical history reported),,,"['Disorientation', 'Dysstasia', 'Paralysis']",1,MODERNA,OT 1081741,FL,83.0,M,"Lost all my vision; A spontaneous report was received from a consumer who was an 83-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lost all my vision (blindness). The patient's medical history, as provided by the reporter, included an eye transplant 9 or 10 years ago. Concomitant medication included acetylsalicylic acid, metformin, tamsulosin, ropinirole, Ramipril, and gabapentin. On 09 Feb 2021 at 10:00 AM, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Lot number: 031M20A) intramuscularly for prophylaxis of COVID-19 infection. On 09 FEB 2021, at exactly 10:00 PM, the patient ""lost all my vision."" He stated he had an adverse reaction to his first injection and said ""my first shot messed up my vision."" By 5 am, his vision was perfect. No treatment medication was reported. Action taken with mRNA-1273 in response to the event was unknown. The event of lost all my vision was considered resolved on 10 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,02/09/2021,0.0,UNK,ACETYLSALICYLIC ACID; METFORMIN; TAMSULOSIN; ROPINIROLE; RAMIPRIL; GABAPENTIN,,Medical History/Concurrent Conditions: Transplant (eye transplant 9 or 10 years ago),,,['Blindness'],1,MODERNA,OT 1081742,,,M,"Myelitis transverse; A spontaneous report report was received from a physician concerning a male patient of an unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and who developed transverse myelitis. The patient's medical history was not provided nor was concomitant medication use. On an unknown date, approximately nine days prior to the onset of the event, the patient received his first of two scheduled doses of mRNA-1273 (LOT unknown) intramuscularly for prophylaxis of Covid-19 infection. It was reported that the patient, a physician, after an extensive neurological workup, was diagnosed with transverse myelitis. His symptoms began, according to report, approximately nine days following vaccine administration. Treatment for the reported event was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, transverse myelitis, was considered unknown. .; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Myelitis transverse'],1,MODERNA,OT 1081743,FL,84.0,F,"Passing out and falling; vomiting; Feeling strange; A spontaneous report ( was received from a consumer concerning a 84-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events loss of consciousness, vomiting, feeling abnormal. The patient's medical history included thyroid disorder and hypertension. Concomitant medications used by the patient were thyroid medication and blood pressure medication. On 12 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, the patient experienced passing out and falling, vomiting and feeling strange. She was taken to the emergency room and was administered IV and had some tests done. The patient was not admitted. The event passing out and falling (loss of consciousness) was considered as medically significant . No Laboratory details were provided. Action taken with mRNA-1273 in response to the events was not reported. On 13 Feb 2021, the outcome of the events, loss of consciousness, vomiting, feeling abnormal were considered as recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/13/2021,1.0,UNK,,Hypertension (two blood pressure pills mentioned in narrative.); Thyroid disorder (Thyroid medication),,,,"['Feeling abnormal', 'Loss of consciousness', 'Vomiting']",1,MODERNA,OT 1081744,MA,,F,"Difficulty in breathing; Rash all over her body; Anaphylactic reaction; A spontaneous report was received from a pharmacist for a 47-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction, rash all over her body and difficulty in breathing. The patient's medical history was not provided. No concomitant product use was reported. On 15 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 24 Feb 2021, 10 days after vaccination the patient experienced an anaphylactic reaction. The patient had severe itching on her palm and knee which later turn into rash. The patient also had swelling of her lips and face. The patient went to the emergency room where she got prednisone 50mg for 3 days. On 26 Feb 2021, the patient got rash all over her body and difficulty in breathing. The patient went again to the emergency room. Treatment information included prednisone 50mg for 3 days. Action taken with mRNA-1273 was unknown. The outcome of the event, anaphylactic reaction was not recovered/ not resolved and the outcome for events rash all over her body and difficulty in breathing was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/24/2021,9.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Anaphylactic reaction', 'Dyspnoea', 'Rash']",1,MODERNA,OT 1081745,,,M,"Hospitalised; A spontaneous report was received from a consumer, concerning a male patient of unspecified age, of unknown age, who received Moderna's COVID-19 vaccine and was hospitalized. The patient's medical history included allergic to iodine. Concomitant product use was not provided by the reporter. On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknow) via unknown route for prophylaxis of COVID-19 infection. On an unspecified date, after vaccination, the patient was hospitalized. Treatment information was not provided. Action taken with mRNA-1273 in response to event were not provided. The outcome of the event hospitalized was unknown at the time of this report..; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,Iodine allergy,,,,['Hospitalisation'],1,MODERNA, 1081746,OH,70.0,F,"began to pass out; because every time I tried to lift my head, I would start blacking out again; dizzy; diaphoresis; fell against the wall; violent high abdominal pain; n having multiple, large formed bowel movements; shaking; chills; nausea; fatigue; This is a spontaneous report from a contactable consumer. This 70-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EM9809) , via an unspecified route of administration on 12Feb2021 at 09:45 (at the age of 70years old) at single dose for covid-19 immunisation. Medical history included hypersensitive to latex, allergies to levaquin, ddavp, CT scan dye, codeine, fentanyl, primary immune deficiency, myasthenia gravis, Sjogren's, autonomic neuropathy, myelodysplastic syndrome, von Willebrand's, Barrett's esophagus on unknown date and unknown if ongoing and received Pfizer Covid vaccine (dose 1, Lot: EL9261) on 22Jan2021 at 2:45am on left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Relevant concomitant medication was not provided. At approximately 9:50 AM on 12Feb2021, the patient received second Pfizer Covid-19 vaccine in left arm at Administration facility. The patient waited the 15 minutes post injection. At approximately 10:19AM, the patient left site & drove to her home without issues. At home approximately at 11:20am, she had violent high abdominal pain like she never had before. she proceeded to the commode and began having multiple, large formed bowel movements then began to pass out. She began to have diaphoresis and violent shaking and chills. She had passed out on commode and fell against the wall. She later managed to pull pants up and crawl with head hanging down stated that because every time she tried to lift her head, she would start blacking out again. This continued until after approximately 20 minutes. She managed to pull herself up to the couch and raise legs high above heart and head and let head hang off couch to restore blood pressure. The patient mentioned that shot triggered something with her autonomic nervous system. On 22Feb2021, she was still with nausea, fatigue and dizziness. The outcome of events was not recovered. No treatment was received for events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,PUB,,,Medical History/Concurrent Conditions: Autonomic neuropathy; Barrett's esophagus; Contrast media allergy; Immune system disorder; Latex allergy; Myasthenia gravis; Myelodysplastic syndrome; Sjogren's disease; Von Willebrand's disease,,,"['Abdominal pain', 'Abnormal faeces', 'Chills', 'Dizziness', 'Fall', 'Fatigue', 'Hyperhidrosis', 'Loss of consciousness', 'Nausea', 'Syncope', 'Tremor']",2,PFIZER\BIONTECH, 1081747,FL,78.0,M,"possible infection around hvalve; hemoglobin dropping rapidly; All over body aches; extreme all over weakness; Blood sugar over 400; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9261), via an unspecified route of administration on 02Feb2021 at 16:30 (at the age of 78-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included esophagectomy on an unspecified date. The patient previously took morphine (UNKNOWN MANUFACTURER) and adhesive tape (UNKNOWN MANUFACTURER and experienced allergy. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1284) on 05Jan2021 at 16:30. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B-12 MANUFACTURER UNKNOWN), clopidogrel (MANUFACTURER UNKNOWN), cyclobenzaprine (MANUFACTURER UNKNOWN), empagliflozin (JARDIANCE), magnesium oxide (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), methocarbamol (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN), ""orevastatin"" (MANUFACTURER UNKNOWN), terazosin (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), co-q10 (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) multivitamin (MANUFACTURER UNKNOWN), turmeric curcumin (MANUFACTURER UNKNOWN), vitamin d-3, b-12-E (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), dicyclomine (MANUFACTURER UNKNOWN) all from unknown indications from unknown dates and unknown if ongoing. On 16Feb2021 at 09:00, the patient experienced all over body aches, extreme all over weakness, blood sugar over 400 and hemoglobin dropping rapidly. The patient was taken to the Emergency Room and was hospitalized. The patient received treatment for the events which included an infusion of iron for dropping hemoglobin and infusion antibiotic for possible infection around ""hvalve."" Lab data included a nasal swab SARS-COV 2 test on 16Feb2021 which was negative. The clinical outcomes of the events hemoglobin dropping rapidly, generalized aching, extreme weakness, blood sugar increased and possible infection were unknown. It was also reported that since the vaccination, the patient had been tested for COVID-19 (on 16Feb2021) and it was negative.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/02/2021,02/16/2021,14.0,OTH,AMLODIPINE; ATORVASTATIN; CLONIDINE; VITAMIN B 12; CLOPIDOGREL; CYCLOBENZAPRINE; DICYCLOMINE; HYDROCHLOROTHIAZIDE; JARDIANCE; MAGNESIUM OXIDE; MELOXICAM; METFORMIN; METHOCARBAMOL; MELATONIN; PANTOPRAZOLE; TERAZOSIN; VENLAFAXINE; COQ10 [UBID,,"Medical History/Concurrent Conditions: Adhesive tape allergy (known allergies: morphine, adhesive); Esophagectomy",,,"['Asthenia', 'Blood glucose', 'Blood glucose increased', 'Haemoglobin', 'Haemoglobin decreased', 'Infection', 'Pain', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1081748,OH,45.0,F,"groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have vertigo spell or throw up; balance unsteady; feeling numbness in left arm; Exhausted/tired; feeling faint; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (No Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9267), left arm on 18Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included overweight, pre-diabetic. The patient did not diagnose with COVID-19. No allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included multivitamin. Shot on Thursday. No problem on Friday. Headache Saturday morning 20Feb2021 06:30 AM. After dinner on 20Feb2021, she had a metallic taste in her mouth started sweating and feeling faint then started shivering and feeling like she was going to either have a vertigo spell or throw up. Ballance unsteady. Drank water got into bed and then she started feeling numbness in her left arm. Exhausted and tired. Sunday tired and groggy. Monday still tired and groggy. Events were non serious. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/20/2021,2.0,WRK,,,Medical History/Concurrent Conditions: Overweight; Pre-diabetic,,,"['Balance disorder', 'Chills', 'Dysgeusia', 'Fatigue', 'Feeling abnormal', 'Headache', 'Hyperhidrosis', 'Hypoaesthesia', 'Somnolence', 'Syncope']",UNK,PFIZER\BIONTECH, 1081749,AL,69.0,F,"checked her BG which was 25; minimally responsive; tiredness; This is a spontaneous report from a contactable pharmacist. A 69-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EN5318), via intramuscular on 12Feb2021 13:00 at single dose in right arm for COVID-19 immunisation. Patient had history of diabetes and had been well controlled for a long time. The patient's concomitant medications were not reported. Shortly after vaccination, patient began complaining of tiredness and told husband she wanted to take a nap. At 16:30 husband found patient minimally responsive and checked her BG (blood glucose) which was 25. Husband gave patient oral forms of sugar and transported to the ER (Emergency Room) where her BG slowly improved to normal range. Outcome of the events was resolved.; Sender's Comments: The patient had history of diabetes. The reported blood glucose decrease and hyporesponsive to stimuli were more likely due to pre-existing diabetes, and less likely causally related to the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/12/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Diabetes,,,"['Blood glucose', 'Blood glucose decreased', 'Fatigue', 'Hyporesponsive to stimuli']",1,PFIZER\BIONTECH,OT 1081750,,,F,"severe reaction/ she said she was very very sick; oxygen level was down for 3-4 hours; everything hurt and was aching; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization, and remdesivir (REMDESIVIR), via an unspecified route of administration from an unspecified date to an unspecified date at an unknown dose (""4 doses"") for COVID-19. Medical history included COVID-19 from Jan2021 to Jan2021. The patient's concomitant medications were not reported. Patient had COVID-19 on January. While she has the COVID-19 infection, she took 4 doses of remdesivir. When she got out of the hospital, after 4 weeks, she had the first dose of the Pfizer COVID-19 vaccine. She thinks that she had taken the vaccine too close to her medication (remdesivir) and because of that, she developed a ""severe reaction"" with the first dose of the vaccine. She said she was ""very very sick: her oxygen level was down for 3-4 hours, everything hurt and was aching"". She said it's like having COVID-19 all over again. Her symptoms lasted for a day but 3-4 days later she still didn't feel good. She wanted to know if she should take the second dose after her reaction with the first dose. She said she wanted to speak with a doctor about her concern. The patient underwent lab tests and procedures which included oxygen saturation: down on her oxygen level was down for 3-4 hours. The action taken in response to the event for remdesivir was post-therapy. The outcome of the events was unknown. The event severe reaction/ she said she was very very sick was assessed as serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,REMDESIVIR,COVID-19,,,,"['Malaise', 'Oxygen saturation', 'Oxygen saturation decreased', 'Pain']",1,PFIZER\BIONTECH, 1081751,NJ,78.0,M,"pneumonia; strange dreams; While there I went into AFIB; I had a dry cough that I attributed to several bouts of dry heaves; I had a dry cough that I attributed to several bouts of dry heaves; This is spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of bnt162b2 (lot number EN5318), via an unspecified route of administration in right arm on 08Feb2021 11:45 at single dose for covid-19 immunization. The patient had no relevant medical history. Concomitant medication included metoprolol, lisinopril, atorvastatin (LIPITOR). The patient experienced pneumonia on 10Feb2021, while there he went into AFIB (atrial fibrillation) on 19Feb2021, he had a dry cough that he attributed to several bouts of dry heaves on 10Feb2021, strange dreams on an unspecified date. The event pneumonia was reported as serious per hospitalization. The patient was hospitalized for pneumonia from 19Feb2021 to 21Feb2021. Previously reported side effects along with strange dreams and he would also like to mention a couple of more issues. Throughout 10Feb2021 and 14Feb2021 adverse reaction period he had a dry cough that he attributed to several bouts of dry heaves, Since the cough continued and he wasn't feeling better he went to emergency care facility on the 19th and he was diagnosed with pneumonia and went to the hospital and was admitted. While there he went into AFIB. Pneumonia was located in left lower lobe (infectious organism). Discharged from hospital on 21Feb2021. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, Hospitalization for 2 days. The patient underwent lab tests and procedures which included covid test nasal swab: negative on 20Feb2021. Therapeutic measures were taken as a result of pneumonia and cough. Treatment included antibiotics. The outcome of events for pneumonia was resolving, for dry cough was not resolved, for other events was unknown. Facility type vaccine: Nursing Home/Senior Living Facility. No other vaccine in four weeks. No covid prior vaccination. Covid test post vaccination: Covid test type post vaccination Nasal Swab, covid test date 20Feb2021, covid test result negative. Not known allergy.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/08/2021,02/10/2021,2.0,SEN,METOPROLOL; LISINOPRIL; LIPITOR [ATORVASTATIN],,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Abnormal dreams', 'Atrial fibrillation', 'Cough', 'Pneumonia', 'Retching', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1081752,FL,69.0,F,"Dermatomyositis rash flare up/ facial skin inflamed, bright red, and swollen; rash on her face; Dermatomyositis rash flare up/ facial skin inflamed, bright red, and swollen; rash on her face; headache; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL9265, expiration date: May2021) via unspecified route of administration in the left arm on 16Feb2021 14:00 at single dose for COVID-19 immunization. Medical history included dermatomyositis since 1993 and sinus problems (sinus disorder). Concomitant medications included immunoglobulin human normal (GAMUNEX) and methotrexate 2.5 mg tablets, both for dermatomyositis; and diphenhydramine hydrochloride (BENADRYL 50 mg) IV as premedication. It was reported that every 2 weeks, a nurse comes to her home and gives her a Gamunex 85gram infusion. She clarified she use 4-Gamunex 20gram vials, and 1 Gamunex 5gram vial to make up her Gamunex 85gram infusion. Product information: Gamunex 5gram Vial (uses 1 vial) (NDC Number: 13533-800-20, Lot Number: B36JE00393, Expiration Date: 20Jul2023) and Gamunex 20gram Vial (uses 4 vials) (NDC Number: 13533-800-24, Lot Number: B8GLE00933, Expiration Date: Aug2023). Reported she takes Methotrexate 2.5mg tablets three times a week. She stated she gets pre-medicated every 2 weeks with IV Benadryl prior to her Gamunex 85gram infusion. She provided the IV Benadryl 50mg product vial information as: (NDC Number: 0641-0376-21, Lot Number: 080010, Expiration Date: Aug2022). The patient previously took budesonide 3 mg capsule (taper dose) from 18Nov2020 to 13Feb2021 for microscopic colitis. On 16Feb2021, on the first day after vaccination, patient had a mild headache. The patient woke up on Saturday morning, 20Feb2021, with her facial skin inflamed, bright red, and swollen. She had a rash on her face as she could feel the unevenness of her facial skin when she placed her hand on her face. Patient reported that she called her neurologist to inform her of the adverse reaction, and her neurologist told her to report the reaction to manufacturer. She said what she experienced on Saturday (20Feb2021) was a Dermatomyositis rash flare up, which for her is very rare. She said she normally doesn't have any skin involvement when she has a Dermatomyositis flare. As a treatment, she said she took generic diphenhydramine 25 mg on 20Feb2021 (lot number: Lot Number: P112026, Expiration Date: Sep2020); and took 2 more since then (She said she takes 1 Diphenhydramine 25mg at a time); and her facial redness is down, but she still has a rash, and her face is a little bit swollen. Her facial skin was still elevated a little bit. Her facial swelling has improved quite a bit from Saturday (20Feb2021), stated she does not have any swelling around her eyes now. She said her facial skin is not as red as it was on Saturday. Outcome of the event headache was recovered on unspecified date in Feb2021; while dermatomyositis rash flare up was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/16/2021,0.0,OTH,GAMUNEX; METHOTREXATE; BENADRYL,,Medical History/Concurrent Conditions: Dermatomyositis; Sinus disorder,,,"['Condition aggravated', 'Dermatomyositis', 'Headache']",1,PFIZER\BIONTECH, 1081753,CA,,F,"lost of her hearing in her right ear; had a ""budding sound like a bee"" in her ears.; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date were not reported), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in Jan2021 (reported as a couple hours or the day after the injection), the patient couldn't hear from both ears and had a ""budding sound like a bee"" in her ears. She specified it only persisted in her right ear and they are concerned that she will permanently lose her earing. The patient consulted an audiologist who said she has a ""lost of her hearing in her right ear"" after vaccination. She added she also went to the urgent care twice and once to the ER. The patient decided not to take the second dose of the vaccine. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/01/2021,,UNK,,,,,,"['Deafness unilateral', 'Tinnitus']",1,PFIZER\BIONTECH, 1081754,FL,73.0,M,"facial drooped right side of face; headache; dry eye, right side; cannot taste anything; tired; This is a spontaneous report from a contactable consumer reported for self. This 73-year-old male received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el9269), via an unspecified route of administration, left arm on 10Feb2021 12:45 at single dose for COVID-19 immunisation. Medical history was none. No covid prior vaccination. No known allergies. Concomitant medications included Pantoprazole and Lisinopril. No other vaccine in four weeks. He experienced facial drooped right side of face; dry eye, right side; cannot taste anything; tired; headache on 13Feb2021 10:00 AM. Ae resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No covid tested post vaccination. No treatments were received. Outcome of the events were not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/13/2021,3.0,PUB,PANTOPRAZOLE; LISINOPRIL,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Ageusia', 'Dry eye', 'Facial paralysis', 'Fatigue', 'Headache']",1,PFIZER\BIONTECH, 1081755,PA,83.0,M,"my AFib kicked in and lasted for over a week; my AFib kicked in and lasted for over a week; This is a spontaneous report from a contactable consumer. A 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL9269), via an unspecified route of administration from 08Feb2021 08:15 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on 21Jan2021 06:45 AM (also at age of 83 years old) on left arm for covid-19 immunization with lot number EK9231. The facility type vaccine was hospital. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included atrial fibrillation from an unknown date. Concomitant medication included apixaban (ELIQUIS). After the second dose, on 08Feb2021 08:45 AM, patient's AFib kicked in and lasted for over a week. Patient didn't received treatment for the event. The outcome of event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/08/2021,0.0,PVT,ELIQUIS,,Medical History/Concurrent Conditions: AFib,,,"['Atrial fibrillation', 'Disease recurrence']",2,PFIZER\BIONTECH, 1081756,MI,85.0,M,"gall bladder issues; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient experienced gall bladder issues on an unspecified date. Consumer is reporting about the Pfizer COVID-19 vaccine on behalf of her father in law, who got his first dose of the vaccine at the health department in (name), and was due to get his second dose on 08Feb2021, but he was in the hospital for like a week and a half. She says after he got out of the hospital they contacted the health department but they said they were only getting Moderna right now and he can't get Pfizer vaccine at that site. She says they have contacted different pharmacies and health care providers but they are not getting anywhere, and he needs to get back to get his second dose but they can't find Pfizer vaccine to get. Reporter clarified that her father in law got his first dose of the vaccine on 18Jan2021, and was due for his second on 08Feb2021, but he was hospitalized. Caller says that her father in law's hospitalization is not related to COVID-19, he had gall bladder issues and was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/18/2021,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['Gallbladder disorder'],1,PFIZER\BIONTECH, 1081757,AK,,F,"almost died from the vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter made the comment that a Rheumatoid Arthritis doctor at Native (ANMC), who is also one of the caller's friends, almost died from the first vaccine. She was hospitalized. The reporter thought maybe she should call this person to see what she had to say, but the person didn't answer. She mentioned she spoke with the person's husband and was told she would not be receiving the second shot because the first one was so traumatic. She is sure this person has already completed a report, she is sure she has done all the right stuff. The outcome of the event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Near death experience'],UNK,PFIZER\BIONTECH, 1081762,ME,75.0,M,"Pfizer-BioNTech COVID-19 vaccine treatment under Emergency Use Authorization(EUA): Male received his second vaccine on February 28, 2021 and had been following the vaccine. Symptoms included nausea, vomiting, hypotension, and bradycardia. He was admitted to the hospital on March 1st. Medical history included Coronary Artery Disease, A-Fib, and a previous CABG procedure.",Yes,03/02/2021,Not Reported,Not Reported,,Not Reported,,02/28/2021,03/02/2021,2.0,UNK,,,"Medical history included Coronary Artery Disease, A-Fib, and a previous CABG procedure.",,,"['Bradycardia', 'Hypotension', 'Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH, 1081763,ME,81.0,F,"Pfizer-BioNTech COVID-19 vaccine treatment under Emergency Use Authorization(EUA): Female died 27 hours after receiving second dose of vaccine. Immediately after vaccine she had rapid breathing, almost hyperventilating. Medical history included Dementia and Parkinson's Disease.",Yes,03/02/2021,Not Reported,Not Reported,,Not Reported,,03/01/2021,03/02/2021,1.0,UNK,,,,,,"['Death', 'Immediate post-injection reaction', 'Respiratory rate increased']",UNK,PFIZER\BIONTECH, 1081909,MN,42.0,F,"DVT blood clot and surface blood clot in lower left leg diagnosed at the ER on 2/12/21. Levonox injections and warfarin have been started. Twice weekly INR checks. No longer need the injections; warfarin is continued. Next INR check is scheduled for Thursday March 11, 2021. Warfarin may need to continue life-long.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/29/2021,02/12/2021,14.0,PUB,"Concerta 54mg, mirena IUD",None,1x DVT in portal liver vein-2010. Resolved. No clotting issues since that time.,,omnipaque-causes me to sneeze x1; miconazole causes blistering rash,"['Deep vein thrombosis', 'International normalised ratio increased', 'Thrombophlebitis superficial', 'Thrombosis', 'Ultrasound scan abnormal']",1,MODERNA, 1081937,PA,66.0,F,"Janssen COVID-19 Vaccine EUA Approximately six hours after administration of the vaccine, patient experienced sever chills and dizziness. Unable to stop shaking, patient took temperature which registered at 95.4F and then 95.1F at 15 minutes. Patient donned flannel pants, thermal shirt, and oversized hooded sweatshirt and got in bed under flannel sheets, two doubled-over blankets, a bedspread, and quilt. A down-filled king-size pillow was placed on top of patient's torso and a space heater was turned on to highest setting. Patient reports heart seemed to be racing, but did not take BP. Unable to quell the chills, the patient continued to shake, developing very stiff shoulders, neck and back as a result. This continued until approximately 2 am. The next morning, patient's temperature was registering at 99.4F and pulse was 96, but patient did not report chills. General muscle aches and mild headache were noted. At time of this report, patient's temperature and pulse are normal (97.6F and 76 pulse).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,"Metformin Hcl Tabs 500 mg 2 tabs am, 1 tab pm Diabetes Type 2 Tradjenta 5 mg 1 tab daily Diabetes Losartan 100 mg 1 tab daily Hypertension Amlodipine 10 mg 1 tab",Primary Conditions (being treated) Diabetes Mellitius Type 2 Essential Hypertension Mild Anemia Onychomycosis Secondary Conditions (not being treated) Microscopic Hematuria Chronic Kidney Disease Stage 3,"Musculoskeletal Problems + Arthritis: Bi-lateral Spondylolysis at L5 Spondylolisthesis at L5-S1 Considerable degenerative changes in the apophyseal joints at L4-5, greater on left knee with minimal grade 1 spondylolisthesis at this level Pectus Excavatum Deformity Mild scarring in the middle lobe of the right lung and lingual Fibroid embedded in cervix History of Ovarian Cysts History of Adenomatous Colonic Polyps History of Asthma History of Laryngospasms","Shingrix - fever of 102, muscular aches, and fatigue -Patient age 64, administered in 2018?","Penicillins Skin rashes, hives Erythromycin Felt like throat was closing, difficulty breathing (may have been due to significant acid reflux at the time) Codeine Light-headedness, fainting Ace Inhibitors Laryngospasms Benadryl Rash Determined by two separate allergists independent of each other: Apples, pears, almonds, cashews, pork, beef, lactose intolerant Horses, cows, cats, dogs Tree pollen, molds, ragweed","['Body temperature decreased', 'Chills', 'Dizziness', 'Headache', 'Musculoskeletal stiffness', 'Myalgia', 'Palpitations', 'Tremor']",1,JANSSEN,IM 1081972,CT,81.0,F,1 st dose lot EL 9262 1/25/21 2nd dose Lot EN 6201 ornENG201 --this was hand written for sure if it is a 6 or a g 2/11/2021 March 4th ER diagnosed with A Fib-----cardiovert--on eliquis twice a day and metoprolol 50 mg twice a day kept in hospital overnight-now home,Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/25/2021,03/03/2021,37.0,OTH,synthroid 75mcg plavix 75mg Vit d 2000iu fish oil 2000mg Lipitor 40mg,no,stroke 2 years ago----,,no,"['Atrial fibrillation', 'Cardioversion']",UNK,PFIZER\BIONTECH,IM 1081981,FL,50.0,F,"patient experienced racing heartbeat, heart pounding sound in ears, chest tightness without shortness of breath., and insomnia. She stated that the symptoms subsided by morning except her heartbeat was still a little elevated in the morning. She did not do anything to treat the symptoms and did not seek medical advice. She contacted me to report her symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PHM,unknown,,,,no known allergies,"['Chest discomfort', 'Heart rate increased', 'Insomnia', 'Tinnitus']",1,JANSSEN,IM 1081983,NY,62.0,F,"Fever, aches",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,SCH,"Lipitor, Benicar, ginger/turmeric vitamin, zertec, Menopause miracle supplement, multi-vitamin",,,,,"['Pain', 'Pyrexia']",1,JANSSEN,IM 1081998,MO,50.0,F,"Fainting, nausea, weakness, dizziness, headache, and chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,PHM,Vitamins,none,none,,Codeine,"['Asthenia', 'Chills', 'Dizziness', 'Headache', 'Nausea', 'Syncope']",UNK,JANSSEN,IM 1082003,CT,26.0,F,"Saturday night: bad headache which started around 7pm and lasted the wholel night Sunday: headache persisted, then ended around noon. Around noon became bloated and then by 5pm I had the runs and was using the bathroom for about 6 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,None,None,None,,"Fruits, mold, dust, ragweed, fur, pet dander, grass","['Abdominal distension', 'Diarrhoea', 'Headache']",1,JANSSEN,SYR 1082014,MN,31.0,F,"Mild headache and nausea set in shortly after the injection on Friday, but went away after rest and eating/drinking. My arm was sore for the entire evening. I woke up around 2am Saturday morning and became dizzy. I fell to the floor and passed out for a short period of time. When I woke, I was extremely nauseous to the point of nearly vomiting. I had chills and fever. I could hardly move due to weakness - I needed help getting back into bed. When I woke the next morning, I had 100.3 fever, I had a headache and my entire body was sore. My fever went away late Saturday afternoon, but I still felt mildly nauseous. It is Monday and I still have mild nausea and light-headedness. My arm is only slightly sore.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/06/2021,1.0,OTH,"Nexplanon birth control implant, Acetaminophen",None,None,,Gluten and wheat sensitivity. Codeine sensitivity,"['Asthenia', 'Chills', 'Dizziness', 'Fall', 'Headache', 'Loss of consciousness', 'Mobility decreased', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,IM 1082037,OH,80.0,M,PATIENT'S WIFE STATED THAT HE HAD SYMPTOMS SIMILAR TO COVID AND WAS ADMITTED INTO THE HOSPITAL.,Not Reported,,Not Reported,Yes,2.0,Not Reported,U,03/06/2021,03/07/2021,1.0,PHM,"PANTOPRAZOLE 40MG, AMLODIPINE 5MG, HYDRALAZINE 50MG, SODIUM BICARB 650MG",,"MYELOMA, TYPE 2 DIABETES, KIDNEY DISEASE",,NO KNOWN ALLERGIES,['Malaise'],1,JANSSEN,IM 1082046,,,U,"Chills, Body Aches, Fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Chills', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1082066,SD,45.0,M,Bamlanivimab infusion 2/19/21 to avoid hospitalization. Symptoms started 2/16/21 and tested COVID 19 positive while becoming significantly symptomatic 2/18/21 at Health Care Center.,Not Reported,,Yes,Not Reported,,Not Reported,Y,02/08/2021,02/16/2021,8.0,PUB,1) ATORVASTATIN CALCIUM 40MG TAB 2) CETIRIZINE 10MG TAB 3) LISINOPRIL 20MG TAB 4) METOPROLOL SUCCINATE 25MG SA TAB 5) MOMETASONE/FORMOTEROL 200/5MCG INH 6) MONTELUKAST NA 10MG TAB 7) TIOTROPIUM RESPIMAT 2.5MCG,COPD Hypothyroidism Afib HTN,COPD Hypothyroidism Afib HTN,,NKDA,"['COVID-19', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1082068,CT,27.0,F,"Patient stated she received her vaccine around 9:50 am and started having symptoms of fever, body aches, HA, chills and nausea around 3:50 pm that afternoon. States fever went as high as 106 degrees. She took tylenol initially for symptoms. As fever continued to increase she called her PCP who told her to take tylenol and motrin at the same time and if temperature did not drop below 103 to report to her local hospital. States her temperature decreased to 102 the next morning on 3/6/21 and then all symptoms resided by afternoon on the 6th.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PUB,unknown,none,unknown,,no known allergies,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1082086,FL,87.0,M,"Patient was vaccinated at pharmacy on 2/9/2021, first dose of Moderna COVID-19 vaccine. Per medical records from hospital: patient developed fever, diarrhea, nausea and abdominal pain on 2/25/2021 and presented to the hospital E.R. on 3/1/2021. Patient was diagnosed with Sepsis and Pneumonia. Cardiac arrest on 3/6/21, renal failure, seizures. Patient tested negative for COVID-19 on 3/1/2021 and 3/8/2021. Patient has declined, was placed intubated and placed on a ventilator. Patient admitted to hospice services on 3/8/2021 and plan is for compassionate removal of life support at hospice. Prognosis is poor.",Not Reported,,Yes,Yes,7.0,Yes,N,02/09/2021,02/25/2021,16.0,OTH,PROSCAR 5 MG ORAL TABLET DAILY FLOMAX 0.4 MG ORAL CAPSULE DAILY FERROUS SULFATE 325 MG ORAL TABLET DAILY CRESTOR 20 MG ORAL TABLET DAILY FISH OIL 1000 MG ORAL CAPSULE DAILY METOPROLOL TARTRATE 12.5 MG ORAL TABLET DAILY PLAVIX 75 MG ORAL TAB,,HYPERTENSION ATRIAL FIBRILLATION CAD CKD ESBL GI BLEED HYPOTHYROIDISM LEFT BUNDLE BRANCH BLOCK HYPOTENSION CARDIOMYOPATHY PAROXSYSMAL SUPRAVENTRICULAR TACHYCARDIA TRIPLE BYPASS SURGERY CARDIAC STENT PLACEMENT X 6 WATCHMAN DEVICE IMPLANT PROSTATE CANCER STSATUS POST RADIATION CYSTOSCOPY WITH FULGURATION 2017,,NO KNOWN ALLERGIES,"['Abdominal pain', 'Adrenal mass', 'Anaemia', 'Cardiac arrest', 'Diarrhoea', 'Endotracheal intubation', 'General physical health deterioration', 'Haematuria', 'Leukopenia', 'Mechanical ventilation', 'Nausea', 'Pleural effusion', 'Pneumonia', 'Pyrexia', 'Renal failure', 'Renal mass', 'SARS-CoV-2 test negative', 'Seizure', 'Sepsis', 'Thrombocytopenia', 'Thrombosis']",1,MODERNA,IM 1082089,OK,78.0,M,"The day after receiving his COVID vaccination, the patient was found unresponsive in his driveway in respiratory distress by his neighbors. EMSA was called and pt transported to ED, where he was intubated and placed on mechanical ventilation. Patient extubated 3/4, but remains critically ill at this time. Neurologic causes are being investigated.",Not Reported,,Yes,Yes,6.0,Not Reported,N,03/02/2021,03/03/2021,1.0,PUB,Atorvastatin 40 mg PO daily gemfibrozil 600 mg po bid dutasteride 0.5 mg PO daily lisinopril 20 mg po daily os-cal 1250 mg po daily centrum silver 1 tab po daily,None,Bilateral cataracts Glaucoma Hyperlipidemia HTN PAD Tachycardia,,NKDA,"['Blood pH increased', 'Critical illness', 'Endotracheal intubation', 'Mechanical ventilation', 'PCO2 increased', 'Respiratory distress', 'Unresponsive to stimuli']",2,MODERNA,IM 1082091,TX,61.0,F,Complained facial redness five minutes after getting vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,Lininopril,None,Hypertension,,Seasonal,['Erythema'],1,JANSSEN, 1082095,CT,34.0,F,"I received the vaccine at 9am on Saturday, March 6th. My arm was immediately very sore throughout the day. Around 9:30pm that night I began to feel nauseous. As the night progressed my symptoms got worse. I experienced intense chills and by 11pm had a 100 degree fever. Sunday, March 7th my fever had decreased, but I continued to feel nauseous and have chills throughout the day. Additionally I felt extremely fatigued, weak, and had a throbbing headache. Completing simple tasks were difficult and exhausting. Monday, March 8th I continue to experience significant fatigue, headache, and muscle weakness, but at less intensity. Also, my right arm where I received the injection is very sore. I have also been somewhat dizzy today. I have been taking Advil, drinking fluids, using an ice pack, and resting as much as I can as part of the treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PVT,None,None,Asthma Migraine,,Spearmint allergy,"['Asthenia', 'Chills', 'Dizziness', 'Fatigue', 'Headache', 'Immediate post-injection reaction', 'Injection site pain', 'Loss of personal independence in daily activities', 'Muscular weakness', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,SYR 1082099,NY,46.0,F,REDDENED RASH/ITCHINESS TO FACE,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PUB,"LEVOTHYROXINE, NORTRIPTYLINE, LINVESS",HYPOTHYROID,,,"COCONUT, PINEAPPLE","['Pruritus', 'Rash erythematous']",1,JANSSEN,SYR 1082116,CA,57.0,F,"Vaccine received from off site facility. Unknown site or lot number. Patient started to experience joint pain the evening of vaccine. Joint pain leading to joint swelling in both knees, wrist and elbow. No fever. Lower leg swelling. Complaint of extreme pain.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/18/2021,02/18/2021,0.0,PVT,Multivitimins,None known,History of Atrial Fibrillation,,"Codeine, Meclofenamate Sodium","['Arthralgia', 'C-reactive protein increased', 'Haemoglobin decreased', 'Joint swelling', 'Pain', 'Peripheral swelling', 'Red blood cell sedimentation rate increased', 'Rheumatoid factor negative']",UNK,PFIZER\BIONTECH, 1082121,MD,81.0,M,"Patient was vaccinated on 2/24/21. On evening of 2/25/21, patient began to experience balance problems. On 2/26/21, patient began to experience tingling and weakness in lower extremities. On 2/27/21, patient required walker to ambulate.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/24/2021,02/25/2021,1.0,PUB,"acetaminophen, ibuprofen, losartan, simvastatin",,"high cholesterol, bph",,none known,"['Balance disorder', 'Muscular weakness', 'Paraesthesia', 'Walking aid user']",2,MODERNA, 1082122,NY,52.0,F,"Janssen covid19 vaccine EUA. Beginning 8 hours after shot, experienced severe chills, head ache, body ache, nauseas and fever which lasted about 18 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,UNK,None,None,None,,Bee sting,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1082127,IN,34.0,F,"7 hours post administration, patient had an anaphylactic reaction. she took liquid Benadryl, administered herself an EpiPen, used an albuterol inhaler and went to the er. Patient recovered while in the er and returned home. At pharmacy on the day of the vaccination clinic, patient stayed in a waiting area 15 mins after getting the vaccine. The way our set up was in the store, patient was sitting next to a kiwi plant in the garden and plant area. she is allergic to kiwi. patient is not certain what caused the reaction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PHM,unknown,unknown,diabetes,,"penicillin, Keflex, ketoprofen, adipex, tree nut kiwi",['Anaphylactic reaction'],1,JANSSEN,IM 1082131,FL,46.0,F,Severe pain in arm at site of shot. Fatigue. Whole body soreness. Feverish without fever. Loss of appetite Headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PHM,Lexapro lo lo estrin Claritin Zyrtec Monteluskin,None,Asthma Allergic person-mostly environmental allergens,,Mild allergy or reaction to amoxicillin,"['Decreased appetite', 'Fatigue', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",UNK,JANSSEN, 1082139,CT,39.0,F,"I got the vaccine on 3/6 around 2:45pm. My arm was sore immediately. Around 8:00pm I was cold and then that progressed to chills all night. By the morning of 3/7, I had a headache and my body was achy. At 7:00am, I had a 102 degree fever which lasted all day. Body aches, headache and chills lasted all day 3/6. At 10:00pm 3/7 my fever was down to 99.9. I still had a dull headache and felt dizzy on the morning of 3/8. Fatigue through the afternoon of 3/8.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,,,,,,"['Chills', 'Dizziness', 'Fatigue', 'Feeling cold', 'Headache', 'Immediate post-injection reaction', 'Pain', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,SYR 1082161,NV,79.0,M,Cardiac Arrest/Death Date of death 03/03/2021 time 01:54 pm,Yes,,Not Reported,Not Reported,,Not Reported,N,03/03/2021,03/03/2021,0.0,SCH,,,,,,"['Cardiac arrest', 'Death']",1,MODERNA,IM 1082172,KY,86.0,F,"THE RESIDENT STARTED HAVING SYMPTOMS OF COVID 19 ON 2/3 (COUGH AND SHORTNESS OF BREATH). RAPID TEST WAS NEGATIVE, BUT PCR TEST WAS POSITIVE. SHE RECEIVED TREATMENT FOR COVID WITH IVERMECTIN, DEXAMETHASONE, ALBUTEROL MDI, MUCINEX, AND Z-PACK. SYMPTOMS PROGRESSED AND SHE PASSED AWAY ON 2/15/21.",Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,N,01/18/2021,02/03/2021,16.0,SEN,"FENTANYL 75MCG Q72HRS, SYNTHROID 125MCG DAILY, PROTONIX 40MG 6 DAYS/WK, ALLOPURINOL 200MG DAILY ZOLOFT 50MG DAILY, VITAMIN D 1000 U DAILY, MIRALAX 17GM DAILY, DUREZOL EYE DROPS DAILY, COLACE 200MG DAILY, XARELTO 20MG DAILY, KLONOPIN 0.5MG Q",,"VASCULAR DEMENTIA, CHF, HTN, PULMONARY HTN, DMII,",,METFORMIN,"['COVID-19', 'Cough', 'Death', 'Dyspnoea', 'SARS-CoV-2 test negative', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1082190,,81.0,M,"Patient hospitalized 2/18/21, second dose was scheduled for 2/23/21. Patient expired in hospital 2/27/21.",Yes,02/27/2021,Not Reported,Yes,9.0,Not Reported,,02/02/2021,02/18/2021,16.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1082192,IL,70.0,M,"At approximately 9:00PM om March 7, 2021 I started to feel very tired and was starting to have trouble breathing. My O2 level was between 89% and 91% and my heart was racing. The oximeter I have showed 98/99 BPM. I also had a temperature of 99.9 degrees. Most of these symptoms started to subside after about 2 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PUB,"Atorvastatin 20mg, Calcium 600 + D, Carvedilol 3.125mg, Famotidine 20mg, Magnesium 500mg, Pro Air HFA, Quetiapine 100mg, Tamsulosin 0.4mg, Enalapril 5mg, Viibryd 40mg, Multivitamin/mineral, Vitamin C","COPD, GERD, Cardiomyopathy, Degenerative Disc Disease, Depression with Anxiety, Bladder Cancer, Asthma","COPD, Asthma, Cardiomyopathy, GERD, Depression",,"Bactrim, Floxin, Fluticasone Propionate, Cipro, Levaquin","['Body temperature increased', 'Dyspnoea', 'Fatigue', 'Palpitations']",1,JANSSEN,IM 1082194,FL,69.0,M,"Four days after first Pfizer dose, experienced onset of atrial fibrillation, a new condition. Since then frequent episodes of AF despite flecainide 100mg BID without signs of resolution. Second dose Feb 22, arrhythmia continues. MD feels that inflammatory action of vaccine may have caused or triggered onset.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/01/2021,02/05/2021,4.0,OTH,"multivitamins, losartan 25mg QD hypertension",None,"Hypertension, positional sleep apnea",,None,"['Arrhythmia', 'Atrial fibrillation', 'Blood test normal', 'Cardiac monitoring abnormal', 'Echocardiogram', 'Electrocardiogram abnormal', 'Electrocardiogram ambulatory', 'Inflammation', 'Thyroid function test normal']",2,PFIZER\BIONTECH,IM 1082197,MA,30.0,F,"**24 weeks pregnant. Due Date 6/24/21. 1st pregnancy** I got the vaccine at 5pm and was fine through the night. I was fine early in the morning and then stated feeling nausea and I vomited 3 times and was unable to retain fluids or food. Everything I tried to consume something I would throw it up. The vomiting and Dehydration was the worst, I had nausea in my first trimester so not sure if it's linked to my pregnancy. I called my OB and spoke with them on the phone, they were concerned at on point but eventually was able to hold down an Gatorade and Tylenol . The other effect I had were mainly fatigue and headache but Tylenol helped with both of those. I still feel tired but other than that no other symptoms. By Friday evening I was feeling fine, the only thins that carried on was fatigue. I didn't experience site pain, no redness, swelling or hurting.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/05/2021,1.0,PVT,Prenatal,,,,Peanut Stone Fruits,"['Dehydration', 'Exposure during pregnancy', 'Fatigue', 'Feeding disorder', 'Headache', 'Nausea', 'Vomiting']",1,JANSSEN,IM 1082208,NH,56.0,M,"Janssen COVID-19 Vaccine EUA I experienced headaches and body aches during the evening of the day I received my shot. The body aches went away during the night, but the headaches have continued into today",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,PVT,levothyroxine,None,hypothyroidism,,None,"['Headache', 'Pain']",1,JANSSEN,IM 1082219,ND,78.0,F,2/3/21 ER to Hospital admit for global weakness.,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/02/2021,02/02/2021,0.0,PUB,1) ALOGLIPTIN 12.5MG TAB 2) APIXABAN 5MG TAB 4) ATORVASTATIN CALCIUM 40MG TAB 5) AmLODIPine 5MG TAB 6) CALCIUM CIT 315MG / VIT D 200IU 7) CHLORTHALIDONE 25MG TAB 8) CLOPIDOGREL BISULFATE 75MG 9) CYANOCOBALAMIN 10,HTN DM2 Rheumatoid Arthritis CKD stage 3 Afib COPD,HTN DM2 Rheumatoid Arthritis CKD stage 3 Afib COPD,,PREGABALIN,"['Asthenia', 'Haemoglobin decreased', 'Troponin increased']",2,MODERNA,IM 1082222,MI,81.0,M,"Tongue felt ""thick"", cheeks tingled, and he developed chest pain.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/03/2021,03/03/2021,0.0,PVT,"aspirin 325 MG tablet atenolol (TENORMIN) 25 MG tablet cholecalciferol (VITAMIN D3) 1,000 unit tablet clopidogrel (PLAVIX) 75 mg tablet EPINEPHrine (EPIPEN) 0.3 mg/0.3 mL AtIn famotidine (PEPCID) 20 MG tablet furosemide (LASIX) 20 MG tablet",no,Coronary artery disease and prostate cancer,,Bee sting anaphylaxis Diazepam Narcotic antagonists,"['Chest pain', 'Electrocardiogram normal', 'Paraesthesia', 'Tongue disorder', 'Troponin normal']",1,PFIZER\BIONTECH,IM 1082234,TX,49.0,F,Bells Palsy,Not Reported,,Not Reported,Yes,2.0,Yes,N,01/19/2021,03/06/2021,46.0,SEN,,None,None,,,"[""Bell's palsy"", 'Cardiovascular evaluation', 'Computerised tomogram', 'Electrocardiogram', 'Magnetic resonance imaging']",UNK,PFIZER\BIONTECH, 1082235,MO,75.0,M,"Pt rec'd vaccine in AM and felt ill in PM (chills, fever, N/V, weak, body aches); got worse next day, went to ER. Temp 101, HR 122, BP 125/95, o2 sat 92, RR 32, in ER. Echo was abnormal (hypokinesis in posterior walls, possible aneurysm), CT abd/pelvis ileus, enteritis, gallstone. PT transferred to ? for higher level of care same day.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,03/02/2021,03/02/2021,0.0,PUB,,,,,,"['Asthenia', 'Body temperature increased', 'Chills', 'Cholelithiasis', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram pelvis abnormal', 'Echocardiogram abnormal', 'Enteritis', 'Hypokinesia', 'Ileus', 'Influenza virus test negative', 'Malaise', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting', 'White blood cell count normal']",2,MODERNA,IM 1082243,IN,55.0,M,Extreme tiredness- slept almost all day Monday,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/07/2021,2.0,OTH,,,,,,"['Fatigue', 'Somnolence']",1,JANSSEN,SYR 1082249,CT,59.0,F,"I had the vaccine at 8:00am Saturday and symptoms started after midnight Sunday. Fever, extreme muscle aches, headache, and fatigue. A bit of stomach upset as well. It is now Monday and I still feel achy and have a headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PVT,Lexapro Estradiol Hormone patch,none,none,,"penicillin, sulfa drugs bee stings-mild allergy","['Abdominal pain upper', 'Fatigue', 'Headache', 'Myalgia', 'Pain', 'Pyrexia']",UNK,JANSSEN,SYR 1082251,TX,71.0,M,Headache in the occipital area,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/08/2021,0.0,OTH,"Eye drops, Flomax",None,Prostate problem,,None,['Headache'],1,JANSSEN, 1082256,NJ,52.0,F,"Patient reported a tingling sensation in her throat/tongue within 5 mins of receiving vaccine. This lasted for less than 15 minutes. Patient was still able to drink water normally and talk normally. She didn't feel her breathing was affected, although she noted she felt her heart was racing as she was becoming more anxious. No treatment was administered. Patient stayed approx 45 minutes after shot and reported she felt fine at the 45 minute mark and was able to leave.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,,,,,,"['Anxiety', 'Palpitations', 'Paraesthesia oral', 'Pharyngeal paraesthesia']",1,JANSSEN,IM 1082280,NY,74.0,F,"pt states that the next day she had low grade fever, fatigue, nausea and malaise. Pt had incontinence, diarrhea and fever never broke. Pt contacted her PCP and he suggested she may have Covid so she got tested. The results were negative. Pt ended up getting worse so contacted her PCP and she was told to the ER hospital to get labs drawn, test for Covid again which was negative. Fever was 102.3. Chest XRAY showed she Pneumonia. Pt was admitted to hospital where she was given antibiotics and fluids. She went into respiratory failure and her Pneumonia turned into bilateral infection. She was unable eat and diarrhea. After 5th day her fever broke and was released on the 6th day. She was on O2 for two weeks after going home. On 3/8/2021 Pt is better now but still tired.",Not Reported,,Yes,Yes,6.0,Not Reported,Y,01/11/2021,01/12/2021,1.0,PVT,none,no,no,,codeine,"['Chest X-ray abnormal', 'Computerised tomogram', 'Diarrhoea', 'Electrocardiogram', 'Fatigue', 'Feeding disorder', 'Incontinence', 'Laboratory test', 'Malaise', 'Nausea', 'Pneumonia', 'Pyrexia', 'Respiratory failure', 'SARS-CoV-2 test negative']",1,MODERNA,IM 1082285,CA,65.0,F,"starting February 5, I had mild swelling in the entire left leg treated with ice and anti-inflammatories. There was no redness, swelling, or pain at injection site. Symptoms seemed to be slowly subsiding. However, Thursday 2/11/21, I had a small patch of itchy, (but not painful) red rash on back of left thigh. By Thursday evening it had doubled in size. Friday am (2/12/21) it was a little bigger still. Then by Friday after work, my entire left leg was moderate to severely swollen and the rash covered a large part of the back of right thigh and was beginning to spread to the back of left calf. Friday evening, I visited Urgent Care. The doctor there was concerned about a a possible DVT and sent me to the ER. At ER, an ultrasound revealed no DVT. At no time did I have a fever. TheER doctor admitted me to the hospital where I remained until the afternoon of Monday, February 15. During hospital stay, I was treated with IV Vancomycin twice per day. That helped quite a bit to reduce rash and swelling but it remains at a mild level. I am currently Doxycycline Hyclate 100 mg every 12 hours for 7 days. I took the first dose of the oral med at the hospital on the day of discharge.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/03/2021,02/05/2021,2.0,PUB,"Meloxicam 7.5 mg daily: Amlodipine-Benazepril 5/20 mg; Protoni generic for Protonix 40 mg: generic for Lunesta 3 mg daily. Tylenol PM 2 per night. Supplements as follows: Vitamin D 10,000 I.U.; Vitamin K2 45 mg; Vitamin A 3000 mcg; Strontiu",None,Rheumatoid arthritis since childhood and monthly eye injections for a retinal corneal vein occlusion diagnosed in 9/20,,Humera and Embrel,"['Blood test', 'Peripheral swelling', 'Rash', 'Rash erythematous', 'Rash pruritic', 'Ultrasound scan normal']",1,MODERNA,IM 1082302,IN,56.0,F,Severe chills and fever beginning approximately 8 hours after injection and lasting for 8 hours. The next day extreme fatigue. Day after that moderate fatigue. Third day still fatigued. Mild headache all three days. Soreness at injection site. Diminished appetite.,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/05/2021,03/05/2021,0.0,UNK,ibuprofin,congestion,,,shellfish,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Injection site pain', 'Pyrexia']",1,JANSSEN,IM 1082308,VA,41.0,F,"Fine the day of the shot (5/6/2021), woke up the next day (5/7/2021) with headache, joint pain, muscle aches, fever, nausea, dizziness and what felt like severe heartburn, frequent urination and stomach pain. As of 5/8/2021 all symptoms have subsided except for let arm still being a little tender, a little sore in left neck and that's it. Everything seems to be fine now",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,Spironolactone 50-mg (but I did not take it that morning because i knew I was getting vaccine),none,Asthma,,Aspirin,"['Abdominal pain upper', 'Arthralgia', 'Dizziness', 'Dyspepsia', 'Headache', 'Myalgia', 'Nausea', 'Neck pain', 'Pain in extremity', 'Pollakiuria', 'Pyrexia']",1,JANSSEN,SYR 1082310,VA,57.0,F,"Facial swelling, Diffuse facial rash- 24 hours after vaccine administation Extreme fatigue- immediately following vaccine x2 days Evaluated by PCP and given IM Benadryl and Decadron",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PUB,Alendronate Wellbutrin XL Cyanocobalamin Ibuprofen Xiddra Zestoretic,None,Depression HTN Osteopenia,,None,"['Fatigue', 'Immediate post-injection reaction', 'Laboratory test normal', 'Rash', 'Swelling face', 'Syncope']",1,JANSSEN,IM 1082312,MO,72.0,M,"1600 day after vaccine presented with N/V and chills. Small bowel obstr-partial. NG tube, fluids. resolved. Admit 3/3 DC 3/8",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,03/02/2021,03/03/2021,1.0,PUB,,,,,,"['Acute kidney injury', 'Blood bilirubin increased', 'Blood lactic acid decreased', 'Chills', 'Dehydration', 'Enteral nutrition', 'Nausea', 'Neutrophil count decreased', 'Procalcitonin increased', 'Small intestinal obstruction', 'Vomiting', 'White blood cell count increased', 'X-ray normal']",2,MODERNA,IM 1082322,PA,80.0,M,"patient presented to ED with chest pain, gone upon arrival to ED, dyspnea on exertion, shortness of breath. no congestion, no cough. Nausea present. patient tested for covid and found to be positive. Received 2nd covid vaccine on 2/3/21",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/03/2021,03/07/2021,32.0,OTH,,presented 3/7/21 to ED with chief complaint of chest pain. He had some shortness of breath and nausea. patient had bypass surgery several years ago with recent caths indicating within normal limits and patient took antacid without relief.,"COPD, CAD, Hyperlipidemia, former smoker",,,"['COVID-19', 'Chest pain', 'Dyspnoea', 'Dyspnoea exertional', 'Nausea', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 1082329,CO,71.0,M,Had A-Fib event requiring hospitalization on 2/16/21. Received TEE and heartversion,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/01/2021,02/14/2021,44.0,PHM,"Lovostatin 40 mg, pantoprazole 40 mg, Tamsulosin 0.4 mg, Belsomra 20 mg, Singulair 10 mg, cyclobenzaprine 10 mg., Tylenol",Low back pain,Low back pain,,None known,"['Atrial fibrillation', 'Cardioversion', 'Echocardiogram', 'Magnetic resonance imaging head', 'X-ray']",UNK,MODERNA, 1082334,IL,60.0,F,"No rxn to dose 1. Dose 2: @10 min had tingling of lips; at 12 min had tingling of tongue [and anxiety from the tingling]; @ 15 min had some SOB and knew this was not just anxiety. Had zero intention of being taken to ER as I could easily tx myself. Took inhalers, extra cetirizine. Did not take epi, though have several pens. @4 hour started feeling weak, severe arm pain. At 6 hours, unbearable arm pain, extreme weakness [did not take BP or pulse ox--though I can and wish I had]. Exceeding thirst, could not get water down fast enough. Reactivation of arachnoiditis symptoms. Started unusual muscle fasciculations in arms, leg, and face [face not normal for me]-took valium and baclofen. Next 36 hours unable Additional information for Item 18: next 48 hours, unable to get out of bed other than to get water. Severe HA upon waking [@16 H post injection]. Severe myalgias, but in areas of known arachnoiditis that have been quiescent for quite some time. Forgot to mention, as I find this strange: prior to going to sleep I had left eye conjunctivitis. Left eye only that still is slightly persistent and doesn't require any care [for me at least] I am currently 72 hours post. Still with HA and some fatigue, though worked today [I WAH for a population health company]. L arm is not as painful as the excruciating pain @ hour 4-16, and no need for additional acetaminophen. I have an exceedingly high pain tolerance due to the arachnoiditis, but this was the first time I took a narcotic in 5 years. 2 .5 mg oxycodone x1, then 600 mg ibuprofen x1, then 1 gm acetaminophen 2 over next 24 hours and nothing since, but it is still quite painful today. Different today than yesterday is the development of what feels like left shoulder bursitis. We'll have to see how this goes over time. There is extensive edema at the site, but not clear erythema [I'm dark skinned]. Still just can't seem to get enough water. Had my first meal last night [made chicken soup]. It's still pretty early on. I'm not even at the 72 hour mark yet, so hopefully things will settle down over the next weeks. I checked the box as life threatening because that was likely early anaphylaxis -- though at first I seriously thought at first I was just anxious because of the lip tingling. This is in defense of the fact I did not self administer epi when I became SOB. I likely should have, but know myself well and did fine without it and with asthma and allergy care. I didn't need extra albuterol after the first 24 hours [though writing this makes me feel SOB just from reliving it]. This second dose is a doozy. Hope this was helpful. I provided you guys with my cell but if you want to follow up, I use my phone for work so if you text first I cant tell you availability.",Not Reported,,Yes,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,"cetirizine, monteleukast, gabapentin, duloxetine, baclofen, pr",seasonal allergies,"arachnoiditis, controlled asthma, seasonal allergies, high cholesterol",,bee/wasps,"['Anaphylactic reaction', 'Anxiety', 'Arachnoiditis', 'Asthenia', 'Bursitis', 'Condition aggravated', 'Conjunctivitis', 'Dyspnoea', 'Fatigue', 'Headache', 'Injection site oedema', 'Mobility decreased', 'Muscle contractions involuntary', 'Myalgia', 'Pain in extremity', 'Paraesthesia oral', 'Thirst']",2,MODERNA,IM 1082335,OH,76.0,F,Patient seen at the ER for symptoms of stroke.,Not Reported,,Not Reported,Yes,,Yes,N,01/28/2021,01/29/2021,1.0,PUB,unknown - Botox Injections,unknown,high cholesterol,,No,['Neurological symptom'],1,PFIZER\BIONTECH,IM 1082336,UT,47.0,F,"It was the Johnson and Johnson shot. Both my husband and I felt mild flu-like symptoms on the same day and yesterday. Today the site where the shot was on my arm is very red, puffy and hot. My flu like symptoms are still here, very mild",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PVT,"Lisinopril, Prozac, Propranolol, Omeprazole,",,,,Allergic to Penicillin,"['Influenza like illness', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth']",UNK,JANSSEN,SYR 1082345,WY,83.0,F,"This patient developed a severe pneumonia, clinically diagnosed as COVID-19 pneumonia, with hypercapnic and hypoxemic respiratory failure, and expired. I am not sure if it was related to the vaccine, but the rapid antigen for Sars-CoV2 was positive and the PCR was negative. I am reporting this event because of the lack of clarity on this issue and the positivity of the Sars-CoV2 was beyond the parameters of 14 days in the phase three trials.",Yes,03/06/2021,Not Reported,Yes,2.0,Not Reported,N,02/05/2021,03/05/2021,28.0,PVT,,,,,,"['COVID-19 pneumonia', 'Death', 'PCO2 increased', 'Respiratory failure', 'SARS-CoV-2 test negative', 'SARS-CoV-2 test positive']",2,MODERNA, 1082352,IL,47.0,F,"vomitting, nausea, extreme muscle soreness-whole body, extreme joint pain, extreme head ache, skin hurt to touch, fever, extreme fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,WRK,"over the counter multi vitamin, allegra, escalopram",none,none,,bee stings,"['Arthralgia', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain of skin', 'Pyrexia', 'Vomiting']",1,JANSSEN,IM 1082355,MD,69.0,M,"per the EUA, cases of COVID-19 vaccination that result in hospitalization or death are to be reported. This patient received Moderna on 2/10 and 1/13. Patient is admitted for mild congestive heart failure secondary to cardiomyopathy",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/10/2021,02/19/2021,9.0,PVT,,,,,Penicillin,"['Cardiac failure congestive', 'Cardiomyopathy']",2,MODERNA,IM 1082357,IL,32.0,F,"'AT APPROX 1007AM, PT C/O LIGHTHEADEDNESS AND DIZZINESS. PT WAS COLD, CLAMMY, PALE AND DIAPHORETIC. NURSE TOOK HER VITALS: B/P100/70, P 38 02 92% RA. PT STATES SHE DOES HAVE A 'PHOBIA OFNEEDLESAND WAS VERY NERVOUS ABOUT COMING TODAY' PT WAS BROUGHT INTO THE NURSERY ROOM WITH ASSISTANCE TO A COUCH. PT WAS INSTRUCTEDTO LAY FLAT. A MAKE SHIFT PILLOW WAS PLACED UNDERHER FEET TO ELEVATE HER LEGS. PT WAS ALERT AND ORIENTED X3. PT DENIES SHORTNESS OF BREATH, CHEST PAIN,OR HEADACHE. SITE OF INJECTIONWAS ASSESSED AS PT C/O A SORE ARM. ARM WAS W/O BRUISING OR SWELLING. PT WAS GIVEN WATER TO DRINK AND STATED SHE WAS 'STARTING TO FEEL BETTER'. PT CONTINUED TO LAY FLAT FOR APPROX 40 MINUTES. PT VITALS WERE RETAKEN: 110/78 P68 PO2 98%RA. PT MOTEHR WAS CONTACTED BY A HOSPITAL VOLUNTEER TO INFORM HER OF WHAT OCCURED. PT STATED SHE FELT WELL ENOUGH TO LEAVE. PT INSTRUCTED IF CONDITION RETURNS ORSHE EXPERIENCES ANY SHORTNESS OF BREATH ORDIFFICULTYBREATHING TO CALL 911. pT WASABLE TO SIT UP WITHOUT DIFFICULTY OR ANY COMPLAINT OF DIZZINESS. PT AMBULATED TO HER VEHICLE WITH 2 PERSON FOR SAFETY. PT WAS DRIVENHOME BY A FRIEND/VOLUNTEER AT THE VACCINE CENTER. 1222: VOLUNTEER CALLED TO CHECK ON PATIENT STATUS, NO ADDITIONAL ISSUES REPORTED - 3/8/21 @ 1253",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PVT,UNKNOWN,,,,UNKNOWN,"['Cold sweat', 'Dizziness', 'Fear of injection', 'Feeling cold', 'Hyperhidrosis', 'Nervousness', 'Pain in extremity', 'Pallor']",1,JANSSEN,IM 1082364,NY,69.0,F,"The patient had the vaccination given at 10: 30 AM on 2/28/2021 and became lethargic and deliriums at 9 pm. She was alert and oriented to person, place and time at baseline, she became confused, not able to find her words, oriented only to person for 3 days. She presented to Hospital on Tuesday 3/2/2021 and improved with conservative measures on Friday 3/5/2021.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,02/28/2021,02/28/2021,0.0,PHM,"Apixaban, atorvastatin, sevelamer",none,"End-stage renal disease on hemodialysis, essential hypertension, paroxysmal atrial fibrillation,",,no known drug allergies,"['Aphasia', 'C-reactive protein increased', 'Confusional state', 'Delirium', 'Disorientation', 'Lethargy', 'Red blood cell sedimentation rate increased']",1,MODERNA,IM 1082367,MA,58.0,F,Vaccine received at 12:30 Physical shakes/chills from 7-9 pm Woke up next morning with a splitting headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,SEN,Daily multi vitamin,No,No,,No,"['Chills', 'Headache']",1,JANSSEN,SYR 1082373,WA,63.0,F,"Swelling in ankles/feet/calves/upper thighs, shortness of breath, fatigue. muscle soreness all over, joint pain (esp. wrists & knees). Was hospitalized for 3 days 3/20 - 3/23/2021.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,12/28/2020,01/23/2021,26.0,OTH,"Citalopram, Losartan, Rosuvastatin, Loratadine",Post nasal drip,None,,"Penicillin, Aspirin, Hydromorphone, Bee Venom, Sulfa, Propoxyphene","['Arthralgia', 'Dyspnoea', 'Fatigue', 'Joint swelling', 'Myalgia', 'Peripheral swelling']",UNK,PFIZER\BIONTECH, 1082386,IL,79.0,F,"Her Husband was unable to wake her the the next morning 03/04/21 0730 ,she would not respond to him , finally he was able to get her sitting up but she would never open her eyes or talk ,he took her to the hospital where she was admitted.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,03/03/2021,03/04/2021,1.0,PUB,"Carbidopa Levodopa, Lexapro, Buspar, Rivastigmine, Memantine, Synthroid",,"Parkinson's disease, Dementia, Hypothyroid",She did fall a few days after the first vaccine which husband didn't think was related until having the worsening of the Parkins,Sulfa,"['Blood test normal', 'Brain scan normal', 'Condition aggravated', ""Parkinson's disease"", 'Somnolence', 'Unresponsive to stimuli']",2,MODERNA,IM 1082389,FL,65.0,F,"High Blood Preaseure 183/79, headache, disorientation, temporary forgetfulness, vomit. All these happened around 9:00 p.m. As soon as those signs appeared we rushed her to the ER. The results showed Brain bleed. She was transfered to Hospital where she was valorated again and other series of test were performed. On Tuesday, 02/16/2021 she was discharged from the hospital with Discharge Diagnoses: //Bilateral subarachnoid hemorrhage //Intractable headache //Essential hypertension, uncontrolled//Generalized anxiety disorder. Thursday 03/04/2021 we follow up with the neurologist. Saturday 03/06/2021 she went to the ER with blood preasure of 189/83.",Not Reported,,Yes,Yes,,Not Reported,N,02/13/2021,02/13/2021,0.0,OTH,"Famotidine 40mg, escitalopram 10mg, Hydrochlorothiazide 12.5mg",,,,,"['Cerebral haemorrhage', 'Disorientation', 'Essential hypertension', 'Generalised anxiety disorder', 'Headache', 'Hypertension', 'Memory impairment', 'Subarachnoid haemorrhage', 'Vomiting']",1,PFIZER\BIONTECH,IM 1082400,KY,84.0,F,Patient developed COVID after vaccines. There was an outbreak at her facility . She ended up with pneumonia and expired on 03/07/2021,Yes,03/07/2021,Not Reported,Not Reported,,Not Reported,N,01/12/2021,03/07/2021,54.0,SEN,unknown,Being treated for Lung CA,Diabetes,,,"['COVID-19', 'Death', 'Pneumonia']",1,PFIZER\BIONTECH,IM 1082401,IN,56.0,F,"I had immediate pain at injection site, which is still tender to the touch. I have experienced extreme fatigue over the past three days. I had diarrhea multiple times starting at 12AM on 03/07/2021. I became extremely weak, dizzy, disoriented, and broke out into a cold, clammy sweat. My skin was very ashen/pale. Did not administer body temperature at time of incident but had cold chills.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/06/2021,1.0,PUB,,,,,,"['Asthenia', 'Cold sweat', 'Diarrhoea', 'Disorientation', 'Dizziness', 'Fatigue', 'Immediate post-injection reaction', 'Injection site pain', 'Pain of skin']",1,JANSSEN,IM 1082421,NJ,20.0,F,"Adverse event: Vasovagal syncope , nausea 2 minutes after injection , treatment - supine leg elevation -- ice - water , outcome : patient felt better after 15 minutes , left pharmacy observation after 30 minutes after injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PHM,Unknown,unknown,"Asthma , Lyme Disease",history of vasovagal syncope,Rocephin,"['Nausea', 'Syncope']",1,JANSSEN,IM 1082442,NC,31.0,F,Patient developed idiopathic pancreatitis the next day requiring hospitalization,Not Reported,,Not Reported,Yes,7.0,Not Reported,N,03/01/2021,03/02/2021,1.0,PVT,none,none,,,Codeine,"['Computerised tomogram', 'Laboratory test', 'Magnetic resonance cholangiopancreatography', 'Oesophagogastroduodenoscopy', 'Pancreatitis']",UNK,MODERNA, 1082467,MD,63.0,F,Pt passed away on 3/6/21.,Yes,03/06/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,03/06/2021,17.0,OTH,,Mitral valve tear was reported by husband.,,,,['Death'],1,MODERNA,IM 1082469,VA,53.0,F,"20 min after dose of moderna vaccine she felt her face get hot and swollen and she felt tingling - 10 more minutes and she felt throat was swelling. Waited another 20 min. Went to ER. Got full body shakes and a full body rash. Given pred, benadryl, treated for anaphylaxis. Symptoms began to recur next day and came to PCP office",Not Reported,,Yes,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,PHM,"rosuvastatin 2.5 mg every other day, align, coQ10, fish oil, magnesium, zinc, claritin, belsomra as needed",none,"congenital spondylolisthesis, glaucoma, hyperlipidemia, atypical melanocytic skin lesions","shingrix - fever, shaking, arm soreness (extreme ) 4 hours",neostigmine shingrix latex - sensitivity,"['Anaphylactic reaction', 'Feeling hot', 'Paraesthesia', 'Pharyngeal swelling', 'Rash', 'Swelling face', 'Tremor']",1,MODERNA,IM 1082477,NE,53.0,F,About 7 hours after receiving the vaccination I had severe chills with shivering and could not get warm. I did not need medical attention and was fine within 2 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,SCH,none,none,none,,none,['Chills'],1,JANSSEN,IM 1082481,NJ,62.0,M,"Fever 101.5, Chills, Body Aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/06/2021,1.0,UNK,"Metformin, Lansoprazole, Verapamil, Clonidine, Irbesartan, Vitamin D3",None,"Diabetes 2, High Blood Pressure, Cough",,None,"['Chills', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1082487,NY,24.0,M,"Fever, nausea, terrible headache",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/08/2021,0.0,PUB,No,No,No,,No,"['Headache', 'Nausea', 'Pyrexia']",UNK,JANSSEN, 1082496,NJ,46.0,F,"Adverse Event: Vasovagal syncope 2- 3 minutes after injection , treatment: supine , legs raise, ice back of head , water Outcomes: after 911 evaluation by EMT patient left the pharmacy",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,none,none,asthma,,none,['Syncope'],1,JANSSEN,IM 1082510,TN,90.0,M,"Patient began feeling ill the evening after receiving the 2nd dose of the Pfizer COVID vaccine on 3/3/21. He woke the next morning with AMS and was admitted to the ED with a fever of 103F. He was initially unresponsive to stimulus but no other symptoms. After arrival, given tylenol and ice packs placed. Awoke upon examination. Admitted for management of UTI with acute metabolic encephalopathy and need for cardiopulmonary monitoring. Discharged to SNF with no complaints on 3/8 for continued PT.",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,03/03/2021,03/03/2021,0.0,PVT,,"Sepsis related to UTI, hypokalemia","History of bladder outlet obstruction, hypertension, hyperlipidemia, TIA, COPD, hypothyroidism, Graves' disease, chronic urinary retention (self caths twice daily), BPH, mild dementia",,,"['Cardiac monitoring', 'Malaise', 'Mental status changes', 'Metabolic encephalopathy', 'Pyrexia', 'Toxic encephalopathy', 'Unresponsive to stimuli', 'Urinary tract infection']",2,PFIZER\BIONTECH, 1082520,TX,42.0,M,Reports slight muscle spasm on injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PUB,Lipitor,,HTN Hyperlipidemia,,Aspirin,"['Injection site reaction', 'Muscle spasms']",1,JANSSEN,IM 1082522,LA,62.0,F,"While waiting the 15 required minutes after the shot was administered..I experianced a headache and left jaw discomfort. Minor arm pain the first day, I expected that. Did my regular errands and was fine, a little tired. The next day, (Sunday)...I went to church, had a headache, arms aching like mad, arthritic symptoms , legs cramping, joint pain in elbows especially, were off the chain! I returned home and took immediately to the couch, where I had a low grade fever and stayed all day. I had no appetite, no energy to get up except to go to the bathroom.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PVT,"Prilosec, Atorvastatin, aspirin, vitamin D","Covid Jan 1-10th, 2021","high cholesterol. arthritis, sleep apnea, may have m.s., they are testing for it. Possible early dementia as well.",,"latex, wasps, shellfish, Penecillin,Prednisone,Sulfa and Iodine","['Arthralgia', 'Asthenia', 'Decreased appetite', 'Fatigue', 'Headache', 'Muscle spasms', 'Pain in extremity', 'Pain in jaw', 'Pyrexia']",1,JANSSEN,IM 1082531,VA,57.0,F,"My headache and nausea started around 10;00pm. By 11:00 I had chills and abdominal cramps as well. I had the headache and nausea throughout the night and into the morning, the chills and cramps stopped sometime during the night. I took Tylenol at 11am. It helped the headache a little but the nausea continued. I took Tylenol again at 3:30pm and 9:30pm. Went to bed at 9:30 and slept until 5:00 am this morning. I still have a slight headache and a little nausea but feel much better today.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,Multi vitamin Magnesium Milk Thistle,None,None,"I had a large warm, red patch on my arm for over a week following my second Shingles vaccine in 2019",Penicillin,"['Abdominal pain', 'Chills', 'Headache', 'Nausea']",UNK,JANSSEN,IM 1082545,,78.0,M,Patient received second dose of Pfizer vaccine on 02/26/21. Starting having a fever from 02/27 and shortness of breath from 02/28.,Not Reported,,Not Reported,Yes,8.0,Not Reported,,02/26/2021,02/27/2021,1.0,UNK,,,,,,"['Dyspnoea', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1082549,OH,69.0,F,"jaw start feeling tight , along tingling around lip areas, patient begin to have a wheezing cough",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,PUB,"albuterol, multiple prescriptions","asthma, htn obesity","asthma, diabetes, obesity",,36 allergies/atropine,"['Cough', 'Joint stiffness', 'Paraesthesia oral', 'Wheezing']",1,JANSSEN,IM 1082557,TX,57.0,F,reports flushing and chills Seen and cleared by EMS,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PUB,none,,,,none,"['Chills', 'Flushing']",1,JANSSEN,IM 1082579,IL,54.0,F,"Heart Palpitations, Heightened anxiety , Sleeplessness for almost 12hours Heart Racing. Heavy beating. Chills, Fever, Lethargy.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/04/2021,02/25/2021,21.0,PHM,Amitriptyline Hcl 25Mg- Symbicort 160/4.5- Black Elderberry Supplement!000 Milligrams 1 daily.- Zinc 50 Mg- D3- 25mcg-,No illness at the time of vaccination.,Asthma - Allergies- Obesity,,"Penacillin, Cephalosporin. All Shellfish","['Anxiety', 'Cardiac stress test', 'Chills', 'Heart rate irregular', 'Insomnia', 'Lethargy', 'Palpitations', 'Pyrexia']",2,MODERNA,IM 1082583,NY,64.0,F,"Severe Chills, headache from 4:00 pm until 10:00. After that sweating, I was in bed from 4 until midnight. Today 03/08/2021 I feel much better, just a slight headache and a little nauseous.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PUB,"Metoprolol Succinate 25 MG, Century Complete 50+ Multivitamin, Calcium 600 MG",Sinusitis,High Blood Pressure,,no,"['Chills', 'Headache', 'Hyperhidrosis', 'Nausea']",1,JANSSEN,SYR 1082586,TX,61.0,F,"Complained of chills 10 minutes after vaccine administration. EMS checked blood sugar but machine could not read. It was either too low or too high.. BP 219/89, EKG was unremarkable. Patient was advised by EMS and NP to be transported to ER but decline. Preferred to be transported to by the husband to PCP.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,OTH,"Metformin, Blood pressure medication (Unknown)",None,Diabetes and Hypertension,,Penicciclin,"['Blood glucose abnormal', 'Chills', 'Electrocardiogram normal']",UNK,JANSSEN,IM 1082599,VA,34.0,M,Patient received vaccine on 3/4 and 3/6 was admitted to hospital for oxygen desaturation.,Not Reported,,Not Reported,Yes,,Not Reported,N,03/04/2021,03/06/2021,2.0,PVT,Unknown,Congenital Diaphragmatic Hernia with Left Lung Hypoplasia,Congenital Diaphragmatic Hernia with Left Lung Hypoplasia,,Unknown,"['Computerised tomogram abnormal', 'Condition aggravated', 'Diaphragmatic hernia', 'Oxygen saturation decreased']",1,PFIZER\BIONTECH,IM 1082600,NJ,78.0,M,"Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient?s wife reported that she notice he was slurring his speech and had some confusion prior to getting vaccinated. They contemplated seeking medical care but wanted to get the vaccinated first. After receiving the vaccine, the vaccine recipient was reported to have fell back in his chair and began seizing. EMS responded and treated the patient. They have no history of seizures. They were transported to emergency department at e Regional Medical Center. The patient was admitted to the intensive care unit for further work up and currently present.",Not Reported,,Not Reported,Yes,,Not Reported,N,03/05/2021,03/05/2021,0.0,PUB,,,Hypertension,,NKDA,"['Fall', 'Intensive care', 'Seizure']",1,PFIZER\BIONTECH,IM 1082601,CT,32.0,F,"Immediately after the shot was given on Saturday 3/6/21, I felt very nauseas. The nausea continued for the next two days. Body aches, headache, and chills set in same day, in the afternoon. I took Tylenol every 6-8 hours until Monday 3/8/21. Exhaustion, dizziness, and some shortness of breath occurred on Monday 3/8/21. Nausea, headache, and exhaustion is still ongoing but not as intense.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/06/2021,0.0,PVT,Magnesium,None,,Headaches from the flu shot due to the egg protein and my sensitivity to eggs and itchiness surround the infection site.,Sulpha Eggs,"['Chills', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Headache', 'Immediate post-injection reaction', 'Nausea', 'Pain']",1,JANSSEN,SYR 1082606,CO,68.0,F,"feeling very tired (within 25 min), headache (within 3 hrs) worsened over the next several hours, muscle aches (within 8 hrs) worsened in time, fever (@100 dgs) with chills (within 8hrs), runny nose, watery eyes and dry mouth (within 8hrs), sinus pain (dry) and loss of appetite Called advice line @ 7am on 3/7/21 to see if I could take Ibuprophen (yes) and that helped. All side effects subsided in @ 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,"multi-vitamin, L-lysine (500mg), B-6 (100 mg), D3 (1,000 IU)",none,none,,"seasonal and environmental allergies. Codeine, amoxicillan.","['Chills', 'Decreased appetite', 'Dry mouth', 'Fatigue', 'Headache', 'Lacrimation increased', 'Myalgia', 'Pyrexia', 'Rhinorrhoea', 'Sinus pain']",UNK,JANSSEN,IM 1082622,TX,51.0,F,"Dizziness, nausea, and light sensitivity",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,UNK,,,,,Amoxicillin,"['Dizziness', 'Nausea', 'Photophobia']",1,JANSSEN,IM 1082624,MD,20.0,M,"chills, shaking, delirium I got progressively more cold and then i started shaking. when i got into bed i was thrashing around for hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,Vyvanse 40 mg Omeprazole 40 mg zyrtec (over the counter for allergies),,Eosinophilic esophagitis Gastric reflux,,"corn, soy, potato, nuts, tree nuts","['Chills', 'Delirium', 'Restlessness', 'Tremor']",,JANSSEN,SYR 1082631,MD,68.0,F,Abdominal cramping Vaginal bleeding,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,OTH,Talzenna Calcium Biotin Metoprolol Entresto Spironolactone Multi vitamin,Breast Cancer Congestive Heart Failure,Breast Cancer Congestive Heart Failure,,None,"['Abdominal pain', 'Vaginal haemorrhage']",1,JANSSEN,SYR 1082657,,68.0,M,"nausea, emesis, muscle aches, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PUB,"amlodipine, nefazadone, cetirazine, naproxen",,"hypertension, depression",,,"['Chills', 'Myalgia', 'Nausea', 'Vomiting']",UNK,JANSSEN,IM 1082661,MI,70.0,M,"Chest pain, shortness of breath, feels like he can't catch his breath. presented to the emergency department with episodes of palpitations and chest pain. Around 530 this evening, the patient was in a store when he started feeling palpitations and irregularity to his heart rate. He states at that time, it did give him a mild anterior chest wall pressure. He denies any diaphoresis, pain radiation or lightheadedness at that time. Symptoms resolved after several hours.",Not Reported,,Not Reported,Yes,,Not Reported,U,03/03/2021,03/04/2021,1.0,OTH,acyclovir (ZOVIRAX) 800 MG tablet atorvastatin (LIPITOR) 10 MG tablet gabapentin (NEURONTIN) 300 MG capsule lansoprazole (PREVACID) 15 MG delayed release capsule levothyroxine (SYNTHROID) 50 MCG tablet metoprolol succinate-XL (TOPROL-XL) 50,Multiple Myeloma,Respiratory Obstructive sleep apnea syndrome � Circulatory Persistent atrial fibrillation Chronic diastolic congestive heart failure (HCC) � Digestive Gastroesophageal reflux disease Obesity � Hematologic Multiple myeloma not having achieved remission (HCC) Multiple myeloma (HCC) � Nervous Hearing loss Peripheral neuropathy due to chemotherapy (HCC) � Endocrine/Metabolic Hypomagnesemia � Other Stem cell transplant candidate Status post autologous bone marrow transplant (HCC),,Revlimid ( lenalidomide) rash,"['Alanine aminotransferase normal', 'Albumin globulin ratio', 'Aspartate aminotransferase normal', 'Band neutrophil count increased', 'Basophil count decreased', 'Blast cells', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bilirubin normal', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine increased', 'Blood glucose normal', 'Blood magnesium normal', 'Blood phosphorus normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood thyroid stimulating hormone normal', 'Blood urea increased', 'Brain natriuretic peptide increased', 'Carbon dioxide normal', 'Chest discomfort', 'Chest pain', 'Computerised tomogram thorax', 'Differential white blood cell count abnormal', 'Dyspnoea', 'Electrocardiogram ST segment depression', 'Electrocardiogram abnormal', 'Eosinophil count normal', 'Globulin', 'Glomerular filtration rate', 'Granulocyte count', 'Haematocrit decreased', 'Haemoglobin decreased', 'Heart rate irregular', 'Lymphocyte count normal', 'Lymphocyte morphology abnormal', 'Mean cell haemoglobin concentration normal', 'Mean cell volume increased', 'Metamyelocyte count', 'Monocyte count increased', 'Myelocyte count', 'Neutrophil count decreased', 'Palpitations', 'Platelet count normal', 'Protein total normal', 'Red blood cell anisocytes present', 'Red blood cell count decreased', 'Red blood cell poikilocytes present', 'Red cell distribution width increased', 'SARS-CoV-2 test', 'SARS-CoV-2 test negative', 'Scan with contrast', 'Supraventricular extrasystoles', 'Troponin I normal', 'White blood cell count decreased']",1,PFIZER\BIONTECH,IM 1082674,MI,72.0,M,"Patient received Covid19(Pfizer) vaccine on 02/26/2021 at 3.55pm and on 02/27/2021 in the morning he had swelling in his left leg ( patient had knee replacement in same leg 9 months ago). He waited 2 days and still no improvement. He went to Beaumont urgent care on 03/03/2021 and he was referred to emergency room at hospital. He was admitted due to blood clot in left leg and lungs, where he had leg surgery. He was prescribed Eliquis 5 mg twice a day.",Not Reported,,Yes,Yes,4.0,Not Reported,U,02/26/2021,02/27/2021,1.0,PHM,"Thiamin , folic Acid, Docusate Sodium, Mylanta Suspension, Multivitamin",Unknown,High Blood Pressure,,No Known Allergy,"['Deep vein thrombosis', 'Peripheral swelling', 'Pulmonary thrombosis', 'Surgery']",1,PFIZER\BIONTECH,IM 1082675,,70.0,F,"Patient received first Pfizer COVID-19 vaccine on 1/20/2021 and second dose on 2/12/2021. Patient had minor symptoms such as body aches with both vaccine doses which resolved. Patient then stated she started to experience headache, nausea, and body aches, decreased oral intake, and chill starting on 2/18/2021. On 2/20/2021 patient had several loss of consciousness episodes. Patient presented to the Emergency Department on 2/21/2021 with a chief complaint of syncope, nausea, and vomiting and subsequently admitted to the hospital for potential sepsis, syncope, hyponatremia, dehydration, lactic acidosis. (Continued on second page)",Not Reported,,Not Reported,Yes,3.0,Not Reported,,02/12/2021,02/18/2021,6.0,UNK,,,,,,"['Chills', 'Dehydration', 'Headache', 'Hyponatraemia', 'Hypophagia', 'Lactic acidosis', 'Loss of consciousness', 'Nausea', 'Pain', 'Syncope', 'Vomiting']",2,PFIZER\BIONTECH,SYR 1082699,LA,37.0,F,"Photosensitivity, pain behind eyes, stiffness in neck, chills and overall body aches lasting over 48 hours post-vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/08/2021,3.0,OTH,None,None,None,,None,"['Chills', 'Eye pain', 'Musculoskeletal stiffness', 'Pain', 'Photosensitivity reaction']",1,JANSSEN,IM 1082702,NY,26.0,F,"I am feeling extremely dizzy, any time I move my head the room spins and my ears get hot. I feel achy all over my body and very very cold. As the day has gone on the dizziness has gotten worse. At times it feels like I?m going to faint. (I haven?t yet fainted) I have not tried any treatment yet hoping it doesn?t last longer then today.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,PUB,"B12: Taken Twice A Day, morning Folic acid: Taken Once A Day, morning Guanfacine (3 mg): Taken Once A Day, morning Naproxen : Taken Once A Day, morning Venlafaxine (150 mg): Taken Once A Day, morning Venlafaxine (75 mg)",,Chronic pain from hypermobility syndrome Asthma,,Percocet Propylene Glycol Apples Pollen Cats and dogs,"['Dizziness', 'Feeling cold', 'Feeling hot', 'Pain', 'Vertigo']",1,JANSSEN,SYR 1082707,MO,55.0,M,death,Yes,03/07/2021,Not Reported,Not Reported,,Not Reported,,03/05/2021,03/07/2021,2.0,PUB,,,,,,['Death'],UNK,MODERNA, 1082713,OH,51.0,F,"Had immunization at 11AM on 3/5/21. At 11PM chills started, by 11:30PM worst chills and teeth chattering. On 3/6/21 at 3AM fever of 101.2, extremely hot. She felt tired and achy all day. In the evening on3/6/21 she had nausea and vomiting for a short time. On 3/7/21 she remained tired, sore and achy. Feeling better today on 3/8/21.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PUB,Unknown,Unknown,"States has underlying health issue- ""similar to auto-immune disorder""",,Unknown,"['Chills', 'Fatigue', 'Feeling hot', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",,JANSSEN,IM 1082717,AZ,88.0,F,Patient dropped dead 24 hours after receiving the vaccine. The vaccine killed her. She received the vaccine 2/16/2021 and died 2/17/2021,Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/17/2021,1.0,SEN,,Positive for Covid 1/16/2021 and negative for Covid 1/17/2021,,,,"['Autopsy', 'Death']",1,MODERNA,UN 1082729,MN,30.0,F,"Began having chills, fever spiked up to 100.7, muscle aches and pain, headache, night sweats. These symptoms lasted approximately 36 hours. Felt lethargic and fatigue for approximately 48 hours after the vaccine. Also had some menstrual bleeding which was brief on 3/5/21, which was the date of the vaccine, and this was not expected. Alternated Tylenol and Ibuprofen after vaccine to help lower fever, and drank fluids.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,UNK,Birth control,,,,Penicillin,"['Chills', 'Fatigue', 'Headache', 'Intermenstrual bleeding', 'Lethargy', 'Myalgia', 'Night sweats', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1082731,VA,42.0,M,"(Janssen COVID-19 vaccine EUA) Day of vaccine - soreness in shoulder at the site of the injection. Day 2 - continuing soreness of shoulder, along with general aches, chills, and sleepiness. Day 3 - continuing soreness in shoulder, but no aches, chills, or sleepiness. Began feeling nauseous, but still had appetite. Day 4 - continuing soreness in shoulder, as well as nausea, but both are somewhat diminished.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,PHM,"Flovent HFA inhaler 110 mcg, fluticasone propionate nasal spray 50 mcg, dicyclomine capsules 50 mg/day",none,asthma,,none,"['Arthralgia', 'Chills', 'Injection site pain', 'Nausea', 'Pain', 'Somnolence']",1,JANSSEN,SYR 1082737,CT,58.0,F,The next morning I woke up with a low-grade fever. It lasted on off that whole day but never went higher than 100.2,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PVT,,None,high blood pressure diabetes type 2 asthma,,Atenolol/Chlothalidone Paroxetine Simvistatin Metformin Ozempic Potassium Chloride Baby Aspirin Fish Oil B-12 Calcium Citrate Prilosec D-3,['Pyrexia'],1,JANSSEN,SYR 1082746,TX,44.0,M,"10 minutes after injection, dizzy spell and vasovagal reaction. Diaphoretic, pulse rate 48, BP 107/71.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PVT,Vit C Tylenol,Nil,Nil,,Peanut,"['Dizziness', 'Electrocardiogram', 'Hyperhidrosis', 'Laboratory test', 'Presyncope']",1,JANSSEN,IM 1082748,MN,67.0,F,"Fever, chills, aches, headache, exhaustion",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,OTH,"Multi vitamins, calcium, fish oil, calcium, biotene, lol dose aspirin, albuterol, Flovent, Miralax, Metamucil, omeprazole",None,Allergies with mild asthma,,"Pollen, mold, dust mites","['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1082754,AZ,69.0,F,"two days after receiving the vaccination my left arm went numb. the next am i went to urgent care and they said pinched nerve - no improvement so went to ER on Monday morning. It was determined that the arteries in my left arm were completely blocked and I was not getting any blood flow to limb. Sent from ER and within hours an emergency throbectomy was performed to save my left arm/hand. Spent a couple days in ICU, total 5 in hospital. Doctors DO NOT KNOW if COVID 19 vaccine could have caused or be partially responsible so they advised me to file a report.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,02/16/2021,02/18/2021,2.0,OTH,pls contact for list of meds - or i will attach if allowed on this website,Sinus / respiratory infection prior,"diabetes, rheumatoid arthritis, asthma",,Penicillin,"['Hypoaesthesia', 'Intensive care', 'Laboratory test', 'Nerve compression', 'Peripheral artery occlusion', 'Poor peripheral circulation', 'Thrombectomy']",1,PFIZER\BIONTECH,IM 1082759,VA,79.0,M,Death,Yes,03/07/2021,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/07/2021,3.0,PHM,Dialysis,"Congestive heart failure, stage 4 renal failure, sepsis and COPD","Congestive heart failure, stage 4 renal failure, sepsis and COPD",,None,['Death'],1,MODERNA,SYR 1082777,TX,58.0,F,"SOB, Lightheaded Ipratropium Bromide 0.5mg/2.5ml nebs treatment given on site by EMS Patient transported to ER after treatment due to c/o SOB",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/08/2021,03/08/2021,0.0,PUB,Inhaler unknown name.,,COPD,,Cipro,"['Dizziness', 'Dyspnoea']",1,JANSSEN,IM 1082784,IA,72.0,F,"Patient is a 72-year-old female presenting with fever and altered mental status. History is obtained for the patient and her husband. She got her second dose of Pfizer vaccine for Covid on 3/6/21. On 3/7/21, she woke with fever and urinary symptoms. She have an episode of incontinence and urinary frequency and urgency today. She was too weak to get up out of the recliner at home. She did have a fever this morning, which resolved with Tylenol. She also has been confused much lower mentally than normal. She is on 4L chronically for COPD, DM, HTN, HLP, CAD, previous DVT. She has had sepsis previously. She was admitted to the hospital, and received one dose of IV Rocephin, IV fluids, and tylenol.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,03/06/2021,03/07/2021,1.0,UNK,,,,,,"['Asthenia', 'Confusional state', 'Incontinence', 'Mental status changes', 'Micturition urgency', 'Pollakiuria', 'Pyrexia', 'Urinary tract disorder']",2,PFIZER\BIONTECH,IM 1082787,KY,88.0,M,Death on 3/7/21,Yes,03/07/2021,Not Reported,Not Reported,,Not Reported,,02/23/2021,03/07/2021,12.0,PUB,,,,,,['Death'],1,MODERNA,IM 1082790,NY,43.0,F,See notes from Dr Shortness of breath later determined as vocal chord dysfunction,Not Reported,,Not Reported,Not Reported,,Yes,N,01/26/2021,01/29/2021,3.0,PVT,Lexapro 10mg,None,Depression,,"All Cillin family, bee venom,","['Dyspnoea', 'Vocal cord dysfunction']",2,PFIZER\BIONTECH,SYR 1082798,TX,,U,Numbness and Tingling,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,None,None,None,,Pencciline,"['Hypoaesthesia', 'Paraesthesia']",1,JANSSEN,IM 1082804,AZ,28.0,M,"Patient committed suicide the morning of March 2, 2021. He stepped in front of a truck on a highway. I consulted with pharmacy and they said that I should report even if the 2 most likely have nothing to do with each other.",Yes,03/02/2021,Not Reported,Not Reported,,Not Reported,N,02/18/2021,03/02/2021,12.0,PVT,not known,anxiety/depression,none known,,not known,['Completed suicide'],UNK,PFIZER\BIONTECH,IM 1082805,NC,59.0,F,"Janssen COVID-19 Vaccine EUA - fatigue, body aches, fever (100.6), headache, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/08/2021,0.0,OTH,"Celexa, B complex vitamin, biotin/collagen vitamin, melatonin at night",None,"Factor V Leiden, depression, anxiety",,"Sensitivity to dairy, wheat, and soy","['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1082808,LA,76.0,M,"patient reported generalized weakness and fall at home which started shortly after receiving vaccine. progressed to the point of severe weakness causing him to fall and not be able to pick himself up from ground. reports that around 2 AM on Friday, 3/5 patient had gotten up to go to the bathroom, he felt very weak, was unable to successfully ambulate to and from the bathroom and had a fall without injury on his way back to the bed. His wife was able to assist him back into bed and he rested later in the morning he got up a second time to go to the bathroom he essentially crawled to the bathroom. he was unable to get back to bed his wife was able to help him to sofa in the living room which was nearby; states that he basically leaned against the sofa until this morning when family arrived and helped bring him to the hospital for evaluation. Patient denies shortness of breath but the patient is breathing approximately 34 times a minute on my physical examination. He denies pain. He has had no nausea or vomiting since his vaccination.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,03/04/2021,03/05/2021,1.0,PHM,"simvastatin 10 mg oral tablet [take 1 tablet (10 mg) by oral route twice a week] potassium citrate 10 mEq (1,080 mg) oral tablet, extended release [take 1 tablet (10 meq) by oral route once daily] pantoprazole 40 mg oral tablet, delayed rel","COVID-19 - in January 13, 2021","Essential (primary) hypertension Other specified diabetes mellitus with diabetic polyneuropathy Hypercalcemia Type 2 diabetes mellitus with diabetic polyneuropathy Atherosclerotic heart disease of native coronary artery without angina pectoris Mild cognitive impairment, so stated Chronic Care Management (CCM) Patient Vitamin D deficiency, unspecified Encounter for general adult medical examination without abnormal findings Morbid (severe) obesity due to excess calories Edema, unspecified Generalized edema Low back pain Anemia, unspecified Unspecified open wound, right lower leg, initial encounter Chronic kidney disease, stage 3b Urinary tract infection, site not specified Mixed hyperlipidemia Retention of urine, unspecified",,NKA,"['Asthenia', 'Blood culture', 'Chest X-ray', 'Computerised tomogram head', 'Computerised tomogram thorax', 'Electrocardiogram', 'Fall', 'Gait disturbance', 'Influenza virus test', 'SARS-CoV-2 test', 'Urine analysis']",2,MODERNA,IM 1082821,WA,86.0,F,Two days after her second Moderna vaccination (administered on 2/25/2021) she developed lesions on her neck. We took her to an urgent care clinic on 3/2/2021 and they diagnosed her with a shingles outbreak more than likely as a result of her vaccination. She did not have any reaction to her first Moderna vaccination four weeks earlier. She was prescribed an anti-viral. She is more comfortable now but her cognitive and physical abilities have declined significantly. She is also having significant sleep issues which have also contributed to her cognitive and physical problems.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/25/2021,02/28/2021,3.0,OTH,"levothyroxine, amlodipine, losartan, duloxetine, folic acid, methotrexate",none,"Dementia, high blood pressure, hypothyroidism, rheumatoid arthritis",,none,"['Cognitive disorder', 'General physical health deterioration', 'Herpes zoster', 'Skin lesion', 'Sleep disorder']",2,MODERNA,IM 1082822,NC,31.0,F,"Severe cold and shivering. Severe light-headedness, fainted, body aches, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,"Levothyroxine Sodium, Sertraline",None,None,,Sulfa,"['Chills', 'Dizziness', 'Failure to thrive', 'Feeling cold', 'Headache', 'Pain']",1,JANSSEN,IM 1082823,IN,52.0,M,"Heart palpitations and feeling flush, extreme feeling of being tired and slight chest discomfort",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/07/2021,0.0,UNK,atorvastatin 10 mg valsartan 160 mg,none,High blood pressure and cholesterol,,none,"['Chest discomfort', 'Fatigue', 'Flushing', 'Palpitations']",1,JANSSEN,IM 1082850,MI,68.0,M,"pt became nauseated and vomiting 1 day after getting vaccine, reported on Mon 2/22/21 but states was getting better, received call from sister on 2/25/21 that pt could not get out of bed on own - was sent to ER at that time",Yes,03/07/2021,Yes,Yes,10.0,Not Reported,N,02/19/2021,02/20/2021,1.0,PVT,"aspirin, atorvastatin, Cymbalta, lyrica, finastride, hydrochlorathiazide iron, losartan, metoprolol tamsulosin, ambien",none,"psoriasis (lips), neuropathy, HTN, anxiety/depression, type 2 DM",,"Penicillin, sulfa","['Computerised tomogram abdomen', 'Computerised tomogram head', 'Computerised tomogram spine', 'Electrocardiogram', 'Laboratory test', 'Mobility decreased', 'Nausea', 'Vomiting', 'X-ray limb']",1,MODERNA,IM 1082851,IN,54.0,F,"Fever, fatigue, nausea, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PUB,"Align probiotic, Fiber Con and VitaminD",,,"Shingles vaccine, same symptoms, January 2021",,"['Fatigue', 'Myalgia', 'Nausea', 'Pyrexia']",1,JANSSEN,SYR 1082854,CO,80.0,F,"Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department with increasing shortness of breath, fever, and cough one day after receiving second vaccine dose. Patient has been experiencing these symptoms for a month prior to arriving at the emrgency department but worsened just prior to arrival. Vital signs: blood pressure 136/75 mmHg, pulse: 96 beats per minute, temperature 36.5 degrees Celsius, respiratory rate 26 breaths per minute, and oxygen saturation 84% on room air (97% on three liters of oxygen via nasal cannula). Physical exam notable for chills, fatigue, fever, cough, dyspnea, nausea, urinary frequency and urgency, headaches, rales, and an irregularly irregular heart rhythm. Patient diagnosed with pneumonia, anemia, gastrointestinal bleeding, and urinary tract infection, administered intravenous fluids and antibiotics, and admitted to another hospital for further care.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/27/2021,02/28/2021,1.0,PVT,"aspirin, irbesartan, levothyroxine, lovastatin, metformin, ropinirole, trazodone, verapamil","fever, persistent cough, worsening dyspnea, and urinary symptoms for one month; receiving home oxygen","diabetes mellitus, hyperlipidemia, hypertension, thyroid disease, obesity",,None reported,"['Anaemia', 'Bacterial test positive', 'Blood electrolytes normal', 'Blood lactic acid normal', 'Brain natriuretic peptide increased', 'Carbon dioxide increased', 'Cardiomegaly', 'Chest X-ray abnormal', 'Chills', 'Cough', 'Dyspnoea', 'Fatigue', 'Fibrin D dimer normal', 'Gastrointestinal haemorrhage', 'Haematocrit decreased', 'Haemoglobin decreased', 'Headache', 'Heart rate irregular', 'Lung opacity', 'Micturition urgency', 'Nausea', 'Pneumonia', 'Pollakiuria', 'Pulmonary oedema', 'Pyrexia', 'Rales', 'Red blood cells urine positive', 'SARS-CoV-2 test negative', 'Troponin normal', 'Urinary tract infection', 'White blood cell count normal', 'White blood cells urine positive']",2,PFIZER\BIONTECH,IM 1082867,CA,36.0,F,"Tongue and throat swelled to the point that she couldn't swallow her own saliva; Tongue and throat swelled to the point that she couldn't swallow her own saliva; Heart rate went pretty high up; Blood pressure went pretty high up; Shaking; Tickle in my throat; Couldn't stop coughing as throat was so irritated; Couldn't stop coughing as throat was so irritated; A spontaneous report (United States) was received from a consumer concerning a 36-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tongue and throat swelled to the point that she couldn't swallow her own saliva, heart rate went pretty high up, blood pressure went pretty high up, shaking, tickle in my throat, couldn't stop coughing as throat was so irritated. The patient's medical history was not provided. The patient was allergic to shellfish, all nuts besides pistachios and cashews, a lot of raw fruits and vegetables, sulfa drugs, latex, Macrobid, and MRI contrast. No relevant concomitant medications were reported. On 13 Jan 2021 at 08:00 PM, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Jan 2021, 3-4minutes after vaccination, the patient's tongue and throat swelled to the point that she couldn't swallow her own saliva, her heart rate and blood pressure went pretty high up, she was also shaking. Patient was at hospital during this time hence she was wheeled to the ER. She adds that she had a tickle in her throat, so she couldn't stop coughing because her throat was so irritated. Patient didn't get any medication for event even as they were busy hence they patient didn't get her epinephrine. Patient also confirmed that she had never had a severe reaction to any type of immunization. Treatment for the event included diphenhydramine before she got to the emergency room. She was supposed to take more of treatment medication and loratadine on 14 Jan 2021 by 11AM as her tongue started swelled up again. Action taken with mRNA-1273 in response to the events were not reported. The outcome of events tongue and throat swelled to the point that she couldn't swallow her own saliva, heart rate went pretty high up, blood pressure went pretty high up, shaking, tickle in my throat, couldn't stop coughing as throat was so irritated were not reported; Reporter's Comments: Based on the current available information and temporal association between the use of the product (LOT 041L20A) and the start date of the events within 3-4 minutes after vaccination, a causal relationship cannot be excluded. Patient's has known hx to allergy to shellfish, all nuts besides pistachios and cashews, a lot of raw fruits and vegetables, sulfa drugs, latex, Macrobid, and MRI contrast. Further information has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,01/13/2021,0.0,UNK,,"Allergy to nuts (Allergy to pistachios and cashews.); Drug allergy (Allergy to sulfa drugs, Macrobid); Food allergy (Allergy to a lot of vegetables and fruits); Shellfish allergy (Allergy to shell fish)",Medical History/Concurrent Conditions: Latex allergy (Allergy to latex),,,"['Cough', 'Heart rate increased', 'Hypertension', 'Oropharyngeal discomfort', 'Pharyngeal swelling', 'Swollen tongue', 'Throat irritation', 'Tremor']",1,MODERNA,OT 1082868,FL,71.0,M,"felt so bad; severe chest pain; Chest pain and arm pain; A spontaneous report was received from a consumer concerning her husband, a 71-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced abnormal feeling, severe chest pain, and arm pain. The patient's medical history, as provided by the reporter, included the patient had a heart attack on 26 May 2020 and on October 2020 the patient had five bypass, two arteries they took. Since October the patient's condition was stated to be great. Concomitant medications reported included Insulin Bovine, Multivitamins [vitamins Nos], acetylsalicylic acid and Medication related to patient's heart attack. On 12 Feb 2021, unspecified days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Feb 2021, post receiving mRNA-1273, the patient had no reaction and did not feel bad. On unspecified day in Feb 2021 one week prior to the reporting the events, the patient experienced chest pain and arm pain, minimum that lasted for 10 minutes. 3 or 4 night prior reporting the event, the patient was feeling abnormal, went to ER and was hospitalized with severe chest pain. The patient was in a regular room and was transferred to ICU. Next day, Cardiac catheterization was performed to see the patient's heart and found that 3 arteries in the original surgery were failing. Treatment for the event, severe chest pain included morphine. Action taken with mRNA-1273 in response to the events was not reported. The event of arm pain was considered Recovered/Resolved. The events, abnormal feeling, severe chest pain were considered as unknown. The patient is still hospitalized.; Reporter's Comments: This case concerns a 71-year-old, male patient, who experienced severe chest pain, feeling abnormal. Cardiac catheterization was performed which showed that 3 arteries in the original surgery were failing. Very limited information regarding this event has been provided at this time. The patient's medical history of heart attack (May 2020) and bypass (October 2020) confounds the causality. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/12/2021,,,UNK,INSULIN 2; MULTIVITAMINS [VITAMINS NOS]; ASPIRIN LOW,Diabetes,"Medical History/Concurrent Conditions: Bypass surgery (Had five bypass, two arteries they took.); Heart attack",,,"['Arterial catheterisation normal', 'Chest pain', 'Feeling abnormal', 'Pain in extremity']",1,MODERNA,OT 1082869,NY,,F,"Anaphylactic; A spontaneous report was received from a nurse concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction. The patient's medical history was provided by the reporter. Concomitant medication included Gabapentin used for unknown indication. On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route at unknown anatomical Location for prophylaxis of COVID-19 infection. On an unknown date, after receiving the first dose of mRNA-1273, the patient had a significant reaction, anaphylactic. The patient was on gabapentin. No treatment information was provided. No relevant laboratory details were included. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,GABAPENTIN,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Anaphylactic reaction'],1,MODERNA,OT 1082870,NC,68.0,F,"Allergic reaction; Tongue felt full; Did not feel well; Puffiness; Trouble swalloing; rash; Swollen glands; Blood pressure high/ changes in blood pressure; Felt faintness; Feeling hot; Fluid accumulation; Turned a dark, pinkish color/ flushed; Changes in heart rate/ heart was racing; A spontaneous report was received from a health care professional concerning a 68-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced allergic reaction/ hypersensitivity, feeling hot, fluid retention, flushing, presyncope, heart rate abnormal, swelling face, tongue felt full/ swollen tongue, hypertension, dysphagia, not feeling well/ malaise, rash, and lymphadenopathy. The patient's medical history, as provided by the reporter, included anaphylaxis to Keflex, lisinopril and sulfa drugs. Concomitant medications reported included HCTZ, diltiazem, rosuvastatin, isosorbide mono, metoprolol and pepcid. On 25 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On the same day patient experienced allergic reactions, feeling hot, fluid retention, flushing, presyncope, high blood pressure, swollen glands. On 26 Jan 2021, the patient was taken into the hospital and kept there for 6 hours. On 29 Jan 2021, the patient still had faintness. Her heart was racing and she did not feel well. On 04 Feb 2021, her tongue felt full and something did not feel right. The patient's vital signs included blood pressure 190/98 and later 140/80. Treatment details included Benadryl, EpiPen, Ativan, Solumedrol, steroids, and Tylenol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, feeling hot, fluid retention, lymphadenopathy, and rash were considered recovered/resolved on an unknown date. The outcome of the events, flushing, and presyncope, was considered not recovered/not resolved. The outcome of the events, allergic reaction, hypertension, heart rate abnormal, swelling face, swollen tongue, malaise, and dysphagia, was not provided.; Reporter's Comments: This case concerns a 68 Y/O F who had serious unexpected hypersensitivity along with unexpected BP high, heart rate abnormal, presyncope, dysphagia, face swelling, swollen tongue, flushing, feeling hot, malaise, fluid retention, and expected rash, lymphadenopathy. Event onset the same day as first dose mRNA-1273. Treated with Benadryl, EpiPen, steroids. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/25/2021,01/25/2021,0.0,UNK,HCTZ; DILTIAZEM; ROSUVASTATIN; ISOSORBIDE MONONITE; METOPROLOL; PEPCID AC,,Medical History/Concurrent Conditions: Anaphylaxis (Anaphylaxis to sulfa drugs.); Anaphylaxis (Anaphylaxis to lisinopril); Anaphylaxis (Anaphylaxis to Keflex),,,"['Blood pressure measurement', 'Dysphagia', 'Feeling hot', 'Fluid retention', 'Flushing', 'Heart rate abnormal', 'Hypersensitivity', 'Hypertension', 'Lymphadenopathy', 'Malaise', 'Presyncope', 'Rash', 'Swelling face', 'Swollen tongue']",1,MODERNA,OT 1082874,CT,48.0,M,"Soreness in upper left arm at injection site; Runny nose; dry throat; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of bnt162b2 (Solution for injection, Lot number: Not reported) via unspecified route of administration on left arm at 10:30, on 28Jan2021 at single dose for COVID-19 immunization at workplace clinic. The patient relevant medical history was none. The patient concomitant medication included finasteride from an unknown date in 2021 (received within 2 weeks of vaccination). On 28Jan2021, the patient experienced soreness in upper left arm at injection site, runny nose, and dry throat. The patient did not receive treatment for the events. The patient hand did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The seriousness of the events was reported as non-serious. The outcome of the events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,WRK,FINASTERIDE,,,,,"['Dry throat', 'Rhinorrhoea', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1082875,PA,38.0,F,"itchy rash all over my stomach by the end of the day it was on my legs, chest, back, neck and arms.; This is a spontaneous report from a contactable other health care professional (patient, self-reported). A 38-year-old female patient (who was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL3246, expiry date was unknown), via an unspecified route of administration, in Arm Left, on 19Jan2021 at 17:00, as single dose for COVID-19 immunization. Medical history included Slight anemic and slight Vit. D deficiency. Concomitant medication included ethinylestradiol, levonorgestrel (VIENVA) as birth control (in two weeks of vaccine). Patient previously took sulfamethoxazole, trimethoprim (BACTRIM), ibuprofen (MOTRIN) and Ibuprofen; had known allergies with these medications. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19 post vaccination. Patient reported that day after vaccine (20Jan2021, 06:00) got a very itchy rash all over my stomach by the end of the day it was on my legs, chest, back, neck and arms. Events resulted in doctor or other healthcare professional office/clinic visit. Patient was prescribed anti-histamine and steroid cream. Outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/20/2021,1.0,PVT,VIENVA,,Medical History/Concurrent Conditions: Anemic (Slight anemic and slight Vit. D deficiency); Vitamin D deficiency (Slight anemic and slight Vit. D deficiency),,,['Rash pruritic'],1,PFIZER\BIONTECH, 1082876,SC,25.0,F,"Redness; hives/urticaria; This is a spontaneous report from a contactable consumer (patient, self-reported). A 25-year-old female patient (who was not pregnant at the time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL3246 and expiry date was unknown), via an unspecified route of administration, in left arm, on 08Jan2021 15:00, as single dose for COVID-19 immunization, at School or Student Health Clinic. Medical history was not reported. Concomitant medications included spironolactone at 100 mg (received within 2 weeks of vaccination). Patient had no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Patient stated that she had no symptoms immediately following my first dose. She was experienced redness and urticaria on 17Jan2021 at 13:00. It only occurred usually at night after showering and while in bed. A 11 days later (after vaccine), began experiencing hives at night every day for about a week until her second dose. She had never experienced hives before and she was not allergic to anything known up to date. Patient was taken benadryl at night or during the day PRN for the events. Outcome of the events was recovered on an unknown date in Jan2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/08/2021,01/17/2021,9.0,SCH,SPIRONOLACTONE,,,,,"['Erythema', 'Urticaria']",1,PFIZER\BIONTECH, 1082879,MN,59.0,F,"Breakout of 4 cold sores lower left lip despite 400mg daily prophylactic acyclovir.; This is a spontaneous report from a contactable nurse. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK4176, intramuscular in the left arm, on 22Jan2021 15:00 at SINGLE DOSE for covid-19 immunization. Medical history included depression, SEM, Herpes Simplex 3 and BET. Concomitant medications included sertraline, clonazepam and propranolol. The patient also had thiomersal allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 25Jan2021, the patient experienced breakout of 4 cold sores lower left lip despite 400mg daily prophylactic acyclovir. The outcome of event was recovered. Follow-up attempts are completed. The information on the batch/lot number has been obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/25/2021,3.0,WRK,SERTRALINE; CLONAZEPAM; PROPANOLOL [PROPRANOLOL],,Medical History/Concurrent Conditions: Benign essential tremor; Depression; Herpes simplex; Systolic ejection murmur,,,['Oral herpes'],1,PFIZER\BIONTECH,OT 1082882,CT,46.0,F,"Extreme soreness in the arm that received the shot; This is a spontaneous report from a contactable consumer (patient herself). A 46-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was unknown), via an unspecified route of administration in arm on 28Jan2021 10:15 AM at single dose for COVID-19 immunization in workplace clinic. The patient's medical history and concomitant medications were none. The patient did not have allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced extreme soreness in the arm that received the shot on 28Jan2021. The event was considered as non-serious by the consumer. No treatment was received for the adverse event. The outcome of the event was recovered on an unspecified date in 2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,WRK,,,,,,['Vaccination site pain'],UNK,PFIZER\BIONTECH, 1082886,TX,40.0,F,"Severe Fatigue; moderate nausea; severe headache; moderate muscle aches; mild diarrhea; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 03Feb2021 08:30 at a single dose for COVID-19 immunization. Medical history included HTN (hypertension), depression, anxiety, RLS (Restless leg syndrome) and insomnia. Patient was not pregnant at the time of vaccination. Concomitant medication included lisinopril, trazodone, clozapine, pramipexole dihydrochloride (MIRAPEX), duloxetine hydrochloride (DULOXEE). The patient experienced severe fatigue, moderate nausea, mild diarrhea, severe headache, moderate muscle aches on 03Feb2021 10:00 with outcome of recovering. No treatment was received. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/03/2021,0.0,PVT,LISINOPRIL; TRAZODONE; CLOZAPINE; MIRAPEX; DULOXEE,,Medical History/Concurrent Conditions: Anxiety; Depression; Hypertension (HTN); Insomnia; Restless leg syndrome (RLS),,,"['Diarrhoea', 'Fatigue', 'Headache', 'Myalgia', 'Nausea']",1,PFIZER\BIONTECH, 1082896,FL,72.0,F,"Headache; Tired; feeling unwell; This is a spontaneous report from a contactable consumer (Patient). A 72-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 02Feb2021 at the age of 72 years old at a single dose for COVID-19 immunisation. The patient medical history was none. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient previously took keflex [cefalexin monohydrate] and experienced allergy, first dose of BNT162B2 (lot number: EI8982) on arm left on 12Jan2021 04:00 PM at the age of 72 years old for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. It was reported that on 02Feb2021 20:00 PM, Headache started about 5-7 hours after injection. Continued for another 24 hours. Tired and feeling unwell also for the 30-36 hours after injection. The patient assessed the events as non-serious. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the events on an unspecified date in Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,UNK,IBUPROFEN; TYLENOL,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Fatigue', 'Headache', 'Malaise']",2,PFIZER\BIONTECH, 1082922,NY,42.0,F,"Subjects has COVID-19; Subjects has COVID-19; This is a spontaneous report received from a contactable consumer. A 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route pf administration on 07Jan2021 at single dose for Covid-19 immunization. Patient medical history and concomitant medications were not reported. Lab data was reported as patient was tested post vaccination and results was reported as unknown. On an unspecified date in Jan2021 it was reported as subjects has COVID-19. Outcome of events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/07/2021,01/01/2021,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1082934,,,F,Headache; This is a spontaneous report from a contactable consumer (patient)via Pfizer Sponsored Program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Headache'],1,PFIZER\BIONTECH, 1082935,MI,,M,"First dose last 20Jan2021 and tested positive after the vaccine; First dose last 20Jan2021 and tested positive after the vaccine; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program, . A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced a positive COVID-19 test on an unknown date after the vaccine. The clinical outcome of the event COVID-19 was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1082939,,,F,"got covid after receiving 1st dose of vaccine; got covid after receiving 1st dose of vaccine; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program, Pfizer First Connect. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced had COVID-19 on an unknown date after receiving the first dose of vaccine. The clinical outcome of the event COVID-19 was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1082941,MI,,F,"tested positive for COVID-19 after the vaccine; tested positive for COVID-19 after the vaccine; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: not reported), via an unspecified route of administration on 20Jan2021 (also reported as 18Jan2021, pending clarification) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient tested positive for COVID-19 after the vaccine. She queried if she still needed the second dose and when she can have it administered. The clinical outcome of ""tested positive for COVID-19 after the vaccine"" was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1082962,NY,45.0,F,"thought she was going to die/She could have died; she couldn't speak/unable to speak very clearly; She lost her voice completely; coughing; itchy throat; very hoarse voice/her voice goes and comes; she got very dark in her face; She had an allergic reaction from the Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer (patient's mother). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on the right arm on 17Feb2021 10:46 at a single dose for covid-19 immunization. The patient medical history included renal failure which she has had since 17Feb2020 and she was on dialysis which started on 04Dec2020. She had had a prior renal transplant before which was on 12Aug2004. Concomitant medications included prednisone, nifedipine (PROCARDIA [NIFEDIPINE]), clonidine, sevelamer, tacrolimus, carvedilol and repaglinide; all were taken from an unspecified date for an unspecified indication. She was on current medication for that for the renal failure. However, at the time of the vaccine her regular medication was on hold, she did not take it because she wanted to do the vaccine. The patient's mother reported that on 17Feb2021 her daughter has been having a lot of difficulty, she couldn't speak, she can't speak properly, unable to speak very clearly. She lost her voice completely/loss of voice, coughing, itchy throat, very hoarse voice, her voice goes and comes, and she got very dark in her face. The patient's mother thought that her daughter was having a stroke. The patient's mother also thought that the patient was going to die. She added that her daughter went to the ER and she still has problems and she could have died. She had an allergic reaction from the Pfizer COVID vaccine. She took the Pfizer vaccine at 10:46 AM. She can't speak now if she does it strains her voice then she was more hoarse. She said after the vaccine this occurred about 30 or 45 minutes. The patient was terrified, she was frightened because she wasn't able to speak. She had coughing, itchy throat, unable to speak clearly. The patient stated that she was dying. They had to get her to the hospital and she stayed over night for observation. She was discharged the next day, she stayed over night because they gave her medications they had to watch and take her vitals and blood work and they came back normal it was just the hoarseness but she had a bad allergic reaction. They gave her a lot of medications to go home on. She said that on 17Feb2021 she went to the hospital and she was discharged home 18 Feb2021. They were doing an EKG, a chest Xray, blood work, those test were being done to make sure her respiratory was okay. She had no swelling, no enlargement or they would have admitted her but all of that was normal and she was discharged home on 18Feb2021 on Solumedrol, Albuterol, Pepcid, Benadryl, Claritin. She had a terrible allergy. She said she was not admitted to the hospital they kept her for observation and she stayed in the emergency room for observation. They gave her an EpiPen. They discharged her home with an EpiPen and Prednisone 40 mg for 4 days. She said that the doctor said if you have an allergy, go to the nearest hospital and that was all being done. She asked what happens now because the patient was supposed to get a second dose but the patient's mother doesn't think so since the patient was terrified. The patient's mother said the vaccine was causing a lot of big allergies up there. She confirmed that it was her daughter experienced. Coughing itchy throat, loss of voice, unable to speak very clearly, and her face was very dark. She said hopefully someone will get back to her. She said the loss of voice after so many days, it has been 7 days now and her voice that way frightens the patient's mother. The outcome of the events was unknown.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/17/2021,02/17/2021,0.0,UNK,PREDNISONE; PROCARDIA [NIFEDIPINE]; CLONIDINE; SEVELAMER; TACROLIMUS; CARVEDILOL; REPAGLINIDE,,Medical History/Concurrent Conditions: Dialysis; Renal failure; Renal transplant,,,"['Aphonia', 'Blood test', 'Chest X-ray', 'Cough', 'Dysphonia', 'Electrocardiogram', 'Hypersensitivity', 'Lack of spontaneous speech', 'Near death experience', 'Skin discolouration', 'Throat irritation', 'Vital signs measurement']",1,PFIZER\BIONTECH, 1082964,FL,84.0,M,"Hematoma at injection site on arm; This is a spontaneous report from a non-contactable consumer (patient). An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had hematoma at injection site on the arm. The adverse event resulted in emergency room/department or urgent care. It was unknown if the patient received treatment for the adverse event. The outcome of the event, hematoma at injection site on the arm, was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,['Vaccination site haematoma'],UNK,PFIZER\BIONTECH, 1082965,OR,39.0,F,"did not have full anaphylaxis; a sense of her throat swelling; hives; This is a spontaneous report from a contactable physician. A 39-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced ""a sense of her throat swelling"" and hives 1 hour after the vaccination occurred. The patient received 1 dose of Benadryl and Tylenol and ""felt ok."" The physician commented that the patient did not have full anaphylaxis and was asking if it would be safe for the patient to receive the second dose of the vaccine at the time of report. The outcome of the events was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Anaphylactic reaction', 'Pharyngeal swelling', 'Urticaria']",1,PFIZER\BIONTECH, 1082967,CA,18.0,M,"Two days after receiving the vaccination, experienced two seizures about 2 hours apart; This is a spontaneous report from a contactable consumer(patient). A 18-year-old male patient received the first dose of BNT162B2 (lot number: E13249), via an unspecified route of administration in right arm, on 15Feb2021 11:00 AM at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Adult Residential Facility. The patient's medical history included developmentally disabled, seizures, malaria at birth. Known allergies included Shrimp, Penicillin and Amoxicillin. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included aripiprazole 5 mg, aripiprazole 10 mg, escitalopram. Two days after receiving the vaccination, the patient experienced two seizures about 2 hours apart on 17Feb2021 14:00. The patient had not had a seizure in 6 months. No treatment was received for the event. The outcome of the event was recovered in Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/15/2021,02/17/2021,2.0,UNK,ARIPIPRAZOLE; ESCITALOPRAM,,Medical History/Concurrent Conditions: Disability; Malaria; Penicillin allergy; Seizures; Shellfish allergy,,,['Seizure'],1,PFIZER\BIONTECH, 1082968,WI,75.0,M,"could not speak; weak in right side; This is a spontaneous report from a contactable consumer (reporting for himself). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EK9231) via an unspecified route of administration, on 25Jan2021 13:00, single dose for COVID-19 immunization. Relevant medical history included subdural hematoma in 2019 (2 years prior), epilepsy, Hyperlipidemia in 2002, Hypertension in 2007, Thyroid disease, appendectomy in 1955, brain surgery (outside of the brain) in 1985, bypass graft femoral to femoral to support R leg blood flow, & Peripheral vascular disease. Concomitant medications were not reported. The patient did not receive other vaccines in the last 4 weeks. The patient was not diagnosed with COVID prior vaccination. On 25Jan2021, at 16:15, the patient was found by a tenant in the car with engine running, could not speak and weak in right side. The patient was taken right away to ER for which the patient as subsequently admitted in the hospital on 25Jan2021 and was discharged on 26Jan2021 (1 day). It was unknown if the patient received treatment in response to the event. The patient was not tested for COVID post vaccination. Outcome was recovered on an unspecified date.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/25/2021,01/25/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Appendectomy; Bypass surgery; Epilepsy; Hyperlipidemia; Hypertension; Peripheral vascular disease; Subdural hematoma (subdural hematoma 2 years prior); Surgery; Thyroid disorder,,,"['Aphasia', 'Hemiparesis']",UNK,PFIZER\BIONTECH, 1082969,NY,69.0,M,"Peripheral neuropathy in his feet/Tingling and burning sensation around the end of his fingertips; This is a spontaneous report from a contactable consumer from the medical information team. A 69-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration, on the left arm, on 27Jan2021 at a single dose (at the age of 69-years-old) for COVID prevention. The patient had no medical history and no concomitant medications. The patient had no other vaccines on the same day as his COVID vaccine. On 09Feb2021, the patient experienced peripheral neuropathy in his feet with a tingling and burning sensation and also reported a tingling and burning sensation around the end of his fingertips. The patient wanted to know if Pfizer has seen this as a side effect to the product and if he should get his second dose or not. The peripheral neuropathy has improved but it was also persisting and stated that it was persisting at a lesser level. The patient was recovering from the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/09/2021,13.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,['Neuropathy peripheral'],1,PFIZER\BIONTECH, 1082970,,,U,"tested positive between doses 1 and 2 of the vaccine; tested positive between doses 1 and 2 of the vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported same events for six patients. This is 1st of Six reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The pharmacist was giving Covid vaccinations in a nursing home. It was reported that the patient was tested positive between doses 1 and 2 of the vaccine, in which the patient was hospitalized and had received antibodies. And had tested negative upon and continuously since returning to the nursing home. Those patients were tested every day. The pharmacist started administering the second doses. One patient was administered the second dose and then somebody said, ""Oh, they were given antibodies in the hospital''. A fellow pharmacist in which they said, we're under the impression you wait 90 days if they've been given antibodies after that to give the second dose. One of the patients inadvertently received a second dose, not knowing that they received antibody therapy prior to administering the vaccine. The rest who were hospitalized did not receive their second injection. Caller asked, ""What is the policy on antibodies and the second dose? When is the earliest date they can administer that second dose? The individual who was given it inadvertently, should they be given a third injection? Do you give them shot number two or do you start over and give them both shots?'' The outcome of event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and drug ineffective due to temporal relationship. This case will be reassessed once additional information is available.,Linked Report(s) : US-PFIZER INC-2021222954 same drug/reporter/event, different patient;US-PFIZER INC-2021222956 same drug/reporter/event, different patient;US-PFIZER INC-2021222957 same drug/reporter/event, different patient;US-PFIZER INC-2021222953 same drug/reporter/event, different patient;US-PFIZER INC-2021222955 same drug/reporter/event, different patient",Not Reported,,Not Reported,Yes,,Not Reported,Y,,,,SEN,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1082971,NJ,75.0,F,"Left 4th Nerve Palsy; This is a spontaneous report from a contactable physician. A 75-year-old non-pregnant female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number: PfEL9Ue2), intramuscularly on 08Feb2021 12:30 at age of 75 years old no pregnant at time of vaccination at single dose in right arm for COVID-19 immunisation. Medical history included diabetes, hypertension, allergies to Penicillin, Sulfa drugs. The patient did not have COVID prior vaccination also not had COVID tested post vaccination. No other vaccine in four weeks. Concomitant medication (other medications in two weeks) included Metoprolol, Metformin, Vitamins. It was reported 6 days after vaccine developed severe diplopia on 14Feb2021 10:00. Exam on 16Feb2021 revealed, Left 4th Nerve Palsy. Left Hypertropia, Esotropia and Torsional strabismus. Events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. No treatment received.; Sender's Comments: Based on the information provided, a causal association between BNT162B2 and IVth nerve palsy cannot be completely excluded in the basis of temporal relation. Note however, that patient has history of diabetes and hypertension which may have contributed to the event. Note also that the event is resolving without treatment received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/16/2021,8.0,SEN,METOPROLOL; METFORMIN,,Medical History/Concurrent Conditions: Diabetes; Drug allergy; Hypertension,,,"['IVth nerve paralysis', 'Physical examination']",1,PFIZER\BIONTECH,OT 1082972,GA,85.0,M,"Developed Covid pneumonia and admitted to hospital; Developed Covid pneumonia and admitted to hospital; This is a spontaneous report from a contactable physician. An 85-year-old male patient received first dose of bnt162b2 (brand: Pfizer, lot number: EL3247), intramuscularly in right arm on 27Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced developed covid pneumonia and admitted to hospital on 10Feb2021, the event was reported as serious per hospitalization. The patient underwent lab tests and procedures which included nasal swab: positive on 15Feb2021. Therapeutic measures were taken as a result of developed covid pneumonia and admitted to hospital. The outcome of event was unknown. Facility type vaccine: Doctor's office/urgent care. The event resulted in hospitalization. No covid prior vaccination. Covid test post vaccination: nasal swab on 15Feb2021 showed positive.; Sender's Comments: Considering the plausible temporal association, the possibility that the reported COVID-19 pneumonia in a setting of drug ineffective is related BNT162B2 vaccine cannot be completely excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/27/2021,02/10/2021,14.0,OTH,,,,,,"['COVID-19 pneumonia', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1082973,TX,71.0,F,"Rash; Fast heart beat; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 20Feb2021 (at the age of 71 years old) at a single dose for covid-19 immunisation; and paracetamol (TYLENOL), via an unspecified route of administration from an unspecified date at unknown dose and frequency for an unspecified indication. Medical history included high blood pressure, rheumatoid arthritis, tinnitus, vertigo, blood cholesterol. Concomitant medications included amlodipine for high blood pressure, lovastatin for blood cholesterol, meclizine [MECLOZINE] for vertigo, dipyridamole for tinnitus, prednisone for rheumatoid arthritis, and folic acid. On 21Feb2021, the patient experienced rash (hospitalization) and fast heart beat. ""If this is the reaction, I guess I shouldn't take the second dose, right? I just think that I am not going to take second dose."" Both the events required emergency room visit. The patient underwent lab tests and procedures which included blood work, electrocardiogram (EKG) and x-ray and everything came back normal on 21Feb2021. Therapeutic measure was taken as a result of the rash which included hydrocortisone. The action taken in response to the events with paracetamol was unknown. Outcome of both events was recovering. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/20/2021,02/21/2021,1.0,UNK,AMLODIPINE; LOVASTATIN; MECLIZINE [MECLOZINE]; DIPYRIDAMOLE; PREDNISONE; FOLIC ACID,,Medical History/Concurrent Conditions: Blood cholesterol abnormal; Blood pressure high; Rheumatoid arthritis; Tinnitus; Vertigo,,,"['Blood test', 'Electrocardiogram', 'Heart rate', 'Heart rate increased', 'Rash', 'X-ray']",UNK,UNKNOWN MANUFACTURER, 1082974,,77.0,M,"Patient hospitalized 10 days later with covid like symptoms, with negative covid test results; This is a spontaneous report received from a contactable consumer (patient's daughter). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot/Batch number: Unknown) on an unknown date via an unspecified route of administration at single dose for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. It was unknown if the patient received other vaccine in four weeks, other medications in two weeks. In Feb2021, the patient hospitalized 10 days later with COVID-19 like symptoms, with negative COVID-19 test results. It was unknown if the patient received treatment for the event. It was unknown if the patient had COVID-19 prior to vaccination and post vaccination. The seriousness of the event was reported as hospitalization. The outcome of the event was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,,02/01/2021,,UNK,,,,,,"['SARS-CoV-2 antibody test', 'Suspected COVID-19']",UNK,PFIZER\BIONTECH, 1082977,,,F,"developed refractory seizures on 04Feb2021 after receiving covid-19 vaccine dose #2; This is a spontaneous report from a contactable physician. A 65-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), intramuscular on 30Jan2021 at a single dose for COVID-19 immunization. Medical history included diabetes, breast cancer, rheumatoid arthritis and known allergies with penicillin. Concomitant medications included metformin (METFORMIN), hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ), letrozole (FEMARA). The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), intramuscular in Jan2021 at the age of 65 years old for COVID-19 immunization. It was unknown if the patient had other vaccines in four weeks. The patient developed refractory seizures on 04Feb2021, after receiving the second dose of BNT162B2 on approximately 30Jan2021. The patient was hospitalized for 5 days, in the ICU and received anti-seizure meds among others. The patient had no COVID prior vaccination and it was unknown if tested post-vaccination. The event resolved on an unspecified date in 2021. Information on the batch/lot number has been requested.",Not Reported,,Yes,Yes,5.0,Not Reported,Y,01/30/2021,02/04/2021,5.0,UNK,METFORMIN; LOSARTAN HCTZ; FEMARA,,Medical History/Concurrent Conditions: Breast cancer; Diabetes; Penicillin allergy; Rheumatoid arthritis,,,['Seizure'],2,PFIZER\BIONTECH,OT 1082978,FL,79.0,M,"Severe thrombocytopenia; This is a spontaneous report from a contactable Nurse. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 at single dose for Covid-19 immunisation. Medical history included rheumatoid arthritis (RA). The patient had known allergies: methotrexate. There were no concomitant medications. No other vaccine in four weeks. The patient experienced severe thrombocytopenia on 17Feb2021. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for severe thrombocytopenia for 2 days. Patient was referred to hematology proactive for severe thrombocytopenia, likely ITP. Platelet (Plts) 5 and then 1. He was sent to the Emergency room (ED) and received plt transfusion w/ minimal effect. He was started on Intravenous Immune Globulin (IVIG) as well as high dose steroids. Plts currently w/i normal range after above treatment. The outcome of event was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the information provided, and on a positive drug-event temporal association, the Company assessed that a reasonable possibility could not be excluded that the suspect product BNT162B2 contributed to the occurrence of the reported event Severe thrombocytopenia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/25/2021,02/17/2021,23.0,UNK,,,Medical History/Concurrent Conditions: RA,,,"['Platelet count', 'Thrombocytopenia']",UNK,PFIZER\BIONTECH, 1082985,MI,86.0,M,Patient had been feeling dyspneic for 1.5 weeks to 1 month prior to his death on 2/28/21. He received vaccine on 2/25/21. On his family found him leaning on the couch with eyes rolled back and foaming at the mouth. He was making noises (like grunting sounds?). EMS was called. He had cardiac arrest while in ambulance enroute to EMS. Resuscitation efforts continued in ED. Family was informed about his status and resuscitation efforts were stopped.,Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,02/25/2021,02/28/2021,3.0,PVT,LISINOPRIL 5MG TAB TAKE ONE TABLET BY MOUTH ONCE DAILY PREDNISONE 5MG TAB TAKE THREE TABLETS BY MOUTH EVERY MORNING TERAZOSIN HCL 10MG CAP TAKE ONE CAPSULE BY MOUTH AT BEDTIME FOR PROSTATE,Worsened dyspnea x 1.5 to 2 weeks prior.,"Polymyalgia rheumatica, on prednisone; diagnosed 9/2020.",,Levothyroxine (lower extremity edema),"['Cardiac arrest', 'Death', 'Dyspnoea', 'Eye movement disorder', 'Foaming at mouth', 'Grunting', 'Resuscitation']",1,PFIZER\BIONTECH,IM 1082989,TX,53.0,M,"Reports he fainted for few minutes. History of same symptom to injection or venipuncture Refused to go to ER, refusal form signed",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/08/2021,0.0,PUB,none,,none,,none,['Syncope'],1,JANSSEN,IM 1082997,KY,66.0,M,"Approximately ten minutes following vaccination patient decided to check his blood pressure at the automated machine because he didn't feel well. Patient passed out sitting at the machine and lost control of his bladder. Patient's eyes were open and he was making snoring noises. Upon checking pulse, it was faint. Patient was breathing. Team moved patient to lying position on the floor. Pulse became more prominent and patient woke up. EMS arrived and took patient to local hospital for precautionary testing. Patient discharge home 2 hours later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,"pantoprazole, allopurinol, aspirin, moexipril, hctz",,,,NKDA,"['Loss of consciousness', 'Malaise', 'Pulse abnormal', 'Snoring', 'Urinary incontinence']",1,JANSSEN,IM 1083005,TX,57.0,F,Nausea seen and cleared by EMS,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/08/2021,0.0,PUB,none,,None,,none,['Nausea'],1,JANSSEN,IM 1083020,VA,73.0,F,Tingling/numbness two middle fingers of same arm. Later had rash in same arm.,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/07/2021,03/07/2021,0.0,UNK,,,,,,"['Hypoaesthesia', 'Paraesthesia', 'Rash']",UNK,JANSSEN, 1083022,TN,22.0,F,8 hours after getting the vaccine I started to get the chills and couldn't get warm. I took my temperature and it was 99.7. I wait a another hour and I still had the chills and started to have terrible body aches. I took my temperature again and it was at 101.3. This stayed the same until the follow day (03/07/2021) My fever finally went down around 2pm. And the body aches stopped around 4pm.,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/06/2021,0.0,SCH,"Gabapentin, birth control, doxycycline",,,,,"['Body temperature increased', 'Chills', 'Feeling cold', 'Pain']",1,JANSSEN,IM 1083023,AZ,70.0,F,"BROWN SPOTTING BLISTERS ON BOTH ARMS, THEN THEY DRY UP AND LEAVE SPOT AND DRY BLISTER FLAKS OFF. IT STARTED ON FIRST SHOT BUT I WAS NOT SURE UNTIL I GOT THE SECOND THAT WHENI REALIZED WHERE THEY WERE COMING FROM. PERM DAMAGE TO SKIN",Not Reported,,Not Reported,Not Reported,,Yes,N,03/01/2021,03/01/2021,0.0,PUB,PLAVIX-PAXIL-ESTRACE-SNYTHROID,,COPD-CAD,,NONE,"['Blister', 'Skin injury']",2,PFIZER\BIONTECH,SYR 1083038,IL,41.0,M,Fever body aches sore back.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,PVT,Lisinopril 20 mg,None,No,,None,"['Back pain', 'Pain', 'Pyrexia']",1,JANSSEN, 1083071,ID,19.0,F,Patient received the Janssen Vaccine Covid-19 injection and immediately afterwards asked for a trash can. She immediately passed out and fell forward. She hit her head on the wall and received a cut. We called the paramedics and she was transported to the emergency room at the local hospital.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/08/2021,03/08/2021,0.0,PHM,,,,,,"['Fall', 'Immediate post-injection reaction', 'Loss of consciousness', 'Skin laceration']",,JANSSEN,IM 1083076,NY,40.0,F,"Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pressure on 2/17/21 and it was 212/116. I was having palpitations and parathesia in my right foot. I immediately contacted my provider and he confirmed my hypertension and I was prescribed two separate anti hypertensive medications. I began these medications however they have been ineffective at treating the high blood pressure. I began to have chest pains, headaches continued, and due to the hypertensive crisis I presented to the ER on 3/3/21 which required IVP BP medications, EKG, cardiac labs, etc. Prior to the COVID vaccination I have always had a normal blood pressure at all of my physical appointments.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/10/2021,02/17/2021,7.0,PVT,"Levothyroxine, methylphenidate, buprenorphine/naloxone, sertraline.","Hypothyroidism , hypersomnia",None,,Know known diagnosed allergies,"['Chest pain', 'Electrocardiogram', 'Headache', 'Hypertensive crisis', 'Laboratory test', 'Palpitations', 'Paraesthesia']",1,PFIZER\BIONTECH,IM 1083085,TX,46.0,F,"itchy, redness on leg",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,UNK,"Tylenol, amlodipine, levothyroxine 10mg, metoprolol 25mcg, omeprazole 20mg, xarelto 20mcg",,,,,"['Erythema', 'Pruritus']",1,JANSSEN,IM 1083099,IA,45.0,M,"Fever of 101�f. Joint pain, Fatigue, Muscle aches. Beginning about 10 hours after vaccination. Lasting about 16 hours. Vomiting and diarrhea with fever of 99�f about 60 hours after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,WRK,"Hydroxyzine, seroquel, once daily multivitamin, and one daily glucosamine.",None,None at this time. Seven years since final chemo disconnect (12 round fol-fox treatment regimen).,,"Most opiates, oxalipolatin iv chemo drug, seasonal pollen allergies.","['Arthralgia', 'Diarrhoea', 'Fatigue', 'Myalgia', 'Pyrexia', 'Vomiting']",1,JANSSEN,IM 1083103,WI,74.0,F,"Patient was admitted to hospital on 3/3/21 for weakness and dehydration. Had presented to ED with nausea, vomiting, and diarrhea for 3 days. Tested COVID 19 positive. Found to be hyponatremic. Was treated with IV fluids. Discharged on 3/6/21. Follow labs on 3/8/21.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/17/2021,03/03/2021,14.0,PVT,chlorthalidone 25 mg tab po daily Enbrel sureclick 50 mg/ml SQ once a week mirtazapine 15 mg daily Prednisone 2.5 mg daily citalopram 10 mg daily metoprolol succinate ER 25 mg 2 tablets daily aspirin 81 mg djialy atrovastatin 10 mg dialy l,Fall on 12/18/21 and complaints of weakness was tested for antibodies for SARS COV2 and was negative on 11/20/21.,"depression Hypertension, hypothyroidism idiopathic myocarditis osteopenia steriod dependence rheumatiod arthritis Sicca syndrome",,NKA,"['Asthenia', 'Blood calcium decreased', 'Blood sodium decreased', 'COVID-19', 'Dehydration', 'Diarrhoea', 'Full blood count', 'Hyponatraemia', 'Metabolic function test', 'Nausea', 'SARS-CoV-2 test positive', 'Vomiting']",2,PFIZER\BIONTECH,IM 1083117,CA,69.0,M,Pt. received his second moderna vaccine on 03/05/2021 and his son reported that the pt. passed away after receiving his vaccine.,Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,PHM,,,"DX: stroke, emphysema",,,['Death'],2,MODERNA,IM 1083123,MD,26.0,F,"Headache, chills, nauseous",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,Advair for asthma,None,Asthma,,None,"['Chills', 'Headache', 'Nausea']",1,JANSSEN,SYR 1083129,VA,65.0,F,"On 3/7/2021 after I returned home, I ate broiled, skinless chicken, salad and small amount of corn at 5:00pm. I started having diarrhea about 5:30pm. Later in the evening around 8:30pm, I had more diarrhea. Around the same time I became very, very sleepy and had extreme fatigue. My right arm where I received the shot did not hurt and still does not hurt. Around 6:00pm, my left arm starting hurting in the same spot where I received the vaccine in the right arm. On the morning of 3/8/2021, I ate breakfast consisting of whole wheat bread and peanut butter and weak coffee (my usual breakfast) and had diarrhea again soon after eating. At 3:30pm, I ate broiled, skinless chicken, green beans and small amount of instant mashed potatoes. Around 5:00pm, I had diarrhea again. I have been drinking a great deal of water on both 3/7/2021 and 3/8/2021 as I normally do every day. At 6:30pm, I had more diarrhea. Soon after, I took two imodium gelcaps and hoping they will help the diarrhea. My left arm has become increasingly more sore and hurts in the muscle. No other symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,PVT,"Prilosec, 20mg, Vitamin D",,"fibromyalgia, spinal stenosis",,"Bactrim, diuretics, sulfa drugs, Trimethoprim, oranges","['Diarrhoea', 'Fatigue', 'Myalgia', 'Pain in extremity', 'Somnolence']",1,JANSSEN,IM 1083140,CO,48.0,M,"Redness and itching at injection site Severe joint pain in neck, shoulder, hipd, knees, ankles for 36 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,UNK,Metformin Verapmil Irbesartan Vitamin Niacin 84mg asparin Magnesium,Asthmatic Pre-diabetic,Asthmatic Pre-diabetic,,None,"['Arthralgia', 'Injection site erythema', 'Injection site pruritus', 'Neck pain']",1,JANSSEN,SYR 1083143,WA,37.0,F,"Janssen COVID-19 Vaccine EUA Chills, Bodyaches, Fever (102.6), Headache, Sweating, Dizzy, Nauseated, very tired. Fever started 4 hours after vaccine and broke the following day around 2pm. I continued to be nauseated, dizzy and have a headache through Sunday March 7th and Monday ( today) I am still tired and have dizzy spells and nauseated off and on. I do feel like it is improving though. The first night was really rough.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/05/2021,03/05/2021,0.0,PHM,None,None,None,,"Shellfish, Sulfa","['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1083146,NM,47.0,F,"Full body aches, 101� Fever, severe headache by 2am 3/6/21; all symptoms continuing through the end of 3/7/21 Resolving by 3/8/21",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,Cymbalta 60mg QD,None,None,,None,"['Headache', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1083148,TX,58.0,F,"Chills, severe headache, tired",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,levothyroxine,,,,Penicillin. Sulphur,"['Chills', 'Fatigue', 'Headache']",1,JANSSEN,IM 1083158,NY,37.0,M,"I received my vaccine this morning at 6:12AM and felt fine after. Around 7:45AM I started to feel slightly short of breathe, but figured it was just from the cold outside and my Asthma. The shortness of breathe feeling goes away. Later in the day sometime after 3 PM, I start to feel as if I am getting stuffy. I take a nap on the buss on my way home, and when I wake up I suddenly feel like I am freezing and have chills all throughout my body. I get home and jump in a hot shower to warm up, but it did not help. I then heat up some food to eat dinner, and I go to drink some soda, and I notice I have no taste. I figured the soda was flat, but even flat soda has some taste to it. I then drink a Cherry Gatorade, and still no taste. Now I check my temperature and it is at 101.4, and I have a slight cough.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,"I have Asthma, therefore I am on an oral steroid called Ellipta, which I must take once a day. I am also on an inhaler called Albuterol, and I take this when needed, which I have not needed to take.",None,Asthma (not chronic).,,None,"['Ageusia', 'Asthma', 'Chills', 'Condition aggravated', 'Cough', 'Dyspnoea', 'Feeling cold', 'Nasal congestion']",1,JANSSEN,SYR 1083159,,73.0,M,"Extreme fatigue for two weeks, change in gait and hand tremors over that time - culminated into - inability to walk, hand tremors, drooping face and slurred, garbled speech - I thought he was having a stroke and called 911",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/15/2021,02/17/2021,2.0,OTH,blood pressure meds,,"CLL, high blood pressure",,None known,"['Blood test', 'Computerised tomogram', 'Dysarthria', 'Electroencephalogram', 'Facial paralysis', 'Fatigue', 'Gait disturbance', 'Gait inability', 'Magnetic resonance imaging head normal', 'Neurological symptom', 'Tremor']",UNK,MODERNA, 1083182,GA,28.0,F,"patient stated she was fine after vaccine, then after a few minutes she stated she felt dizzy. before pharmacist could get back around counter to patient, she fainted and slid out of her chair. patient was alert moments after landing on the floor. patient was laid out on floor and vitals monitored. once vitals returned to normal and patient felt better, she was given water and a banana. EMT arrived and evaluated patient. patient was taken to hospital per EMT suggestion. time frame: 17:26-17:52",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,Patient did not state any medication history,none,none,,NKA,"['Dizziness', 'Syncope']",7+,JANSSEN,IM 1083192,MD,26.0,F,"The injection site is swollen with redness, very painful to touch and painful to move. There is also lingering pain after any moment of the arm or anything touches the injection site. I also have some itchiness on the injection. The pain has gotten wores today (Monday 3/8) which is more than 72 hours after I received the vaccine Friday (3/5) morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,OTH,Junel Fe 20mg,,Hidradenitis Suportiva,,,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site swelling', 'Pain']",1,JANSSEN,IM 1083193,VA,33.0,F,"Extreme muscle aches, low grade temperature of 94�, highest temp up to 99.7�, extremely low energy. Next morning, sore ears and throat. Temperature down to 95� on second day. Craving salt. Still extremely low energy, but aches are more mild.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/07/2021,0.0,UNK,"Levothyroxine, estyrella, B12",,Hypothyroid,,,"['Asthenia', 'Body temperature increased', 'Ear pain', 'Myalgia', 'Oropharyngeal pain', 'Pain']",1,JANSSEN,SYR 1083215,CT,34.0,F,"I first had chills and a low-grade fever with a migraine. That was around 5 PM that night. At around 9:00 PM I had chills, migraine, bodyaches, burning sensation in my joints, neck pain, and a low-grade fever. I took some Tylenol at around 7 PM. But the pain did not subside and I was able to use the bathroom the next day at around 4 AM and was still in severe pain. That day at around 1 PM I was able to set up and felt 30% better. On day two I am feeling better but I still have minor body aches I do get fatigue while doing light work around the house and no appetite and loss of taste is the newest symptom. I am not 100 percent better but close to it.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,UNK,Tylenol,None,Heart murmur Asthma,,Known,"['Ageusia', 'Arthralgia', 'Chills', 'Decreased appetite', 'Fatigue', 'Migraine', 'Neck pain', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1083225,,35.0,F,Headache body ache nauseous dizzy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,UNK,"Metformin, lexapro, lisiprol, Omperzole, actos,",None,Diabetes,,Latex,"['Dizziness', 'Headache', 'Nausea', 'Pain']",1,JANSSEN,SYR 1083232,CT,49.0,F,"High Blood Pressure, Jaw Pain !0/10, headache, nausea, involuntary leg movement We are deeply concerned about getting patient the care she needs. There is a lack of urgency on the part of the hospital staff in acknowledging a connection to her receipt of vaccine and onset of adverse symptoms.",Not Reported,,Yes,Yes,2.0,Not Reported,N,03/06/2021,03/06/2021,0.0,PVT,"anti-depressant, birth control",None,None,,None,"['Dyskinesia', 'Headache', 'Hypertension', 'Nausea', 'Pain in jaw']",UNK,JANSSEN,SYR 1083241,AZ,40.0,F,"1/20/20 extreme fatigue at work and got lost/confused on drive home, weakness, uncoordinated, admitted to hospital 1/26 with stroke like symptoms, still to date 3/8 ongoing neurological issues, weak tingling limbs, memory/focus, speech, balance, extreme fatigue, unable to drive or work, unsteady if on feet for more than short amount of time, spacial awareness off sometimes run into objects and miscalculating placing items back on shelves",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/14/2021,01/20/2021,6.0,PUB,,,Well controlled type 2 diabetes,,Neosporin,"['Asthenia', 'Balance disorder', 'Blood test normal', 'Computerised tomogram', 'Confusional state', 'Coordination abnormal', 'Disturbance in attention', 'Fatigue', 'Impaired driving ability', 'Impaired work ability', 'Magnetic resonance imaging', 'Memory impairment', 'Muscular weakness', 'Neurological symptom', 'Paraesthesia', 'Speech disorder']",2,MODERNA,IM 1083246,TX,87.0,F,Experienced burning sensation on her throat 10 minutes after receiving the vaccine,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,"Experienced burning sensation on her throat 10 minutes after receiving the vaccine. Denies difficulty swallowing. BP 157/85 , O2 sat 97%",,"Hypothyroidism, Anxiety, GERD",,NKA,['Throat irritation'],,JANSSEN,IM 1083248,CT,41.0,F,"Fever of 102 all night, taken with forehead scanner. Highest fever 103. Headache and rapid heartbeat all night. Next day headache. Arm soreness started Two days after the shot and continues, very painful in the muscle and skin is itchy over the injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,SCH,,,,,"Sulfa, benedryl","['Headache', 'Heart rate increased', 'Injection site pain', 'Injection site pruritus', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,IM 1083268,NC,22.0,F,"Chills, disoriented, nausea, extreme fatigue, fever nightmares, head ache, teeth ache, muscle ache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,UNK,,,IBS,,"Tree nuts, egg intolerance","['Chills', 'Disorientation', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia', 'Toothache']",1,JANSSEN, 1083279,,27.0,M,"101.7 F fever, nausia, tiredness, runny nose, headache the night and day after the vaccine, that went away after 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PHM,,,,,,"['Fatigue', 'Headache', 'Nausea', 'Pyrexia', 'Rhinorrhoea']",1,JANSSEN,IM 1083282,CA,24.0,F,"@04:27 pm patient reported having tightness in chest, used albuterol per NP X2. Patients vitals were BP 131/82 HR 99 O2 100%. Patient continued to report sharp pain in chest and heaviness with tingle in throat, denied difficulty swallowing, no swelling noted. Pt was picked up by EMS at 4:45pm.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,03/08/2021,03/08/2021,0.0,PUB,,,,,,"['Chest discomfort', 'Chest pain', 'Pharyngeal paraesthesia']",2,MODERNA,IM 1083283,IN,59.0,F,"Usual chills, headache, fever and neck pain beginning at 10:00 pm. Woke up at 6:00 am with throat swelling. Went to emergency room",Not Reported,,Yes,Yes,3.0,Not Reported,Y,03/04/2021,03/04/2021,0.0,PHM,"Benicar, Lexapro",,Gastric bypass patient,,,"['Blood test', 'COVID-19', 'Chills', 'Computerised tomogram intestine', 'Headache', 'Neck pain', 'Pharyngeal swelling', 'Pyrexia', 'SARS-CoV-2 test positive', 'X-ray']",1,MODERNA,SYR 1083289,,46.0,F,"Injection site is still sore, chills, severe head ache and severe body aches lasting for two full days post vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/05/2021,03/06/2021,1.0,UNK,,,,,,"['Chills', 'Headache', 'Injection site pain', 'Pain']",UNK,JANSSEN, 1083291,CA,69.0,F,"My second COVID-19 vaccination injection on Friday morning, 2/19/2021 resulted initially (starting on Saturday, the day following the vaccination} in a sore right wrist and a much more painful right arm that steadily grew in intensity and spread rather rapidly into my upper torso. By the following day (Sunday, 2/21) my breasts became very sensitive and I had severe pains across my back. This may or may not have been the beginning of a banding type MS exacerbation, but by Monday, 2/22, it was clear that I was experiencing a full-blown and seriously disabling exacerbation. Both legs experienced the tingling and numbness I have had in a prior exacerbation, and by the time I was able to talk to Dr. (my neurologist) on Monday afternoon (2/22), the numbness had progressed upward into my lower abdomen and I was no longer able to stand at all. It appears highly likely that the MS attack was triggered by the response of my immune system's reacting to the discomfort and severe body pains that occurred following the vaccination. I told Dr. of the total loss of feeling and use of both legs and was experiencing a increasing numbness from toes up to abdomen. Before ordering the high doses of corticosteroids used to stop my exacerbation, Dr. sent me to the Emergency Room for testing to make sure I did not have an infection that could be covered up by the steroids. When this testing did not show any such infection, the ER administered an IV infusion of 1 gram of solumedrol, followed by gradually decreasing high oral doses of prednisone. As of this date, numbness has started decreasing and some limited utility of right leg has returned. Still i can no longer stand and perform even the minimal movements to-and-from wheelchair to bed or toilet without substantial physical help (not needed before this exacerbation) from my sole caregiver, my husband.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/19/2021,02/22/2021,3.0,PUB,"ALPRAZOLUM (XAXAX generic), ATROVENT HFA, CALCIUM (LIQUID), CLOBETASOL 0.05% OINTMENT, CREON 1212, FUROSEMIDE, HYDROCODONE-APAP 5-325 (NORCO generic), KETOCONAZOLE 2% CREAM, LUNESTA, POLYETHYLENE GLYCOL, 3350 POWDER, MONUROL, OMEPRAZOLE, PR","RELAPSING/REMITTING MULTIPLE SCLEROSIS, OSTEOPOROSIS, (chronic) URINARY TRACT INFECTION, HYPERTENSION","MS, OSTEOPOROSIS, UTI",Temporary injection site soreness that went away within a day or two,"ALL DAIRY PRODUCTS, SOY MILK, MOST PORK PRODUTS, COPAXONE, DEMAROL, DILANTIN, PNEUMONIA SHOT, PREVACID, SEPTRA, SULFUR medications, TEGRETOL, NUTMEG, HCTZ","['Arthralgia', 'Back pain', 'Breast discomfort', 'Chest pain', 'Condition aggravated', 'Discomfort', 'Dysstasia', 'Hypoaesthesia', 'Injection site pain', 'Mobility decreased', 'Multiple sclerosis', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Sensory loss', 'Urinary tract infection', 'Wheelchair user']",2,PFIZER\BIONTECH,IM 1083296,NE,48.0,F,"started sore arm soon after, arm pain persisted, heart racing, dry mouth, sore swollen throat, severe headache, spasm in arm",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PVT,none,none,none,,none,"['Dry mouth', 'Electrocardiogram', 'Headache', 'Muscle spasms', 'Pain in extremity', 'Palpitations', 'Pharyngeal swelling']",1,JANSSEN,IM 1083301,TX,43.0,F,Uncontrollable shaking for about half an hour,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,PHM,,,Myotonic dystrophy,,,['Tremor'],1,JANSSEN,SYR 1083314,CT,50.0,F,"Vaso Vagal Syncope. Felt warm and dizzy. Previous episodes after vaccines, blood draws, family events. No itching, hives, SOB, tongue or mouth swelling, palpitations. Supine on floor for several minutes and symptoms resolved. Walked around with no return of symptoms. Released to go home. Advised to seek treatment if symptoms return. Lungs CTAB, no hives. BP WNL after resting.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PUB,"Wellbutrin, prozac,",,"Vaso Vagal Syncope, depression, anxiety","2018 summer, unknown vaccine before trip, Syncope",Shellfish,"['Blood pressure normal', 'Dizziness', 'Feeling hot', 'Syncope']",1,JANSSEN,IM 1083317,NY,21.0,F,"About 12 hours after the vaccine, I experienced excruciating pain in my head and body. My fever rose to 102 and stayed there for 36 hours after being vaccinated. I was also nauseous and was unable to keep food down until 48 hours after being vaccinated. I was taking both Tylenol and Advil, but getting sick almost instantly after taking them.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,OTH,"Adderall XR, birth control",,asthma,"mild flu symptoms from the flu shot at ages 15, 16, and 17.","Penicillin, amoxicillin","['Headache', 'Malaise', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1083324,,52.0,F,Headache - pain scale 3/10 - not worst headache of life. patient took Aleve and drank water with full resolution.,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/08/2021,0.0,OTH,,,,,,['Headache'],1,JANSSEN,IM 1083327,IL,42.0,M,"20 minutes after receiving vaccine patient reports paresthesia in bilateral feet traveling up legs to bilateral arms and hands. Patient reports fatigue and headache. Patient able to hydrate with water. After 1 hour of observation, patient reports symptoms improved significantly. Patient informed to take Acetaminophen/Ibuprofen, to consume food/fluids and rest. Advised to follow up with primary care physician. Advised to call 911 if symptoms persist or respiratory distress. Patient declined transportation to hospital for evaluation. Patient reports able to drive home safely which is about 10 minutes away. Patient was ambulatory upon discharge. BP 118/80. HR 82.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PUB,None,None,February -March 2020 diagnosed and recovered from COVID-19.,,None,"['Fatigue', 'Headache', 'Paraesthesia']",1,JANSSEN,IM 1083339,,51.0,M,"numb/tingle lip/tongue; no SOB, no CP, HR 67, O2-98; No stridor, no swelling",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/08/2021,0.0,OTH,,,,,,"['Hypoaesthesia oral', 'Paraesthesia oral']",1,JANSSEN,IM 1083341,CT,46.0,M,"Vasovagal Syncope - seated talking immediately after vaccine. Suddenly stopped and fell off chair onto gym floor. Regained consciousness after 30 - 60 seconds and was light headed and was diaphoretic. No SOB, swelling, itching, hives, difficulty speaking or swallowing, hoarse voice, palpitations, CP, headache. AO x 3. No hives or rash. Ambulance called but patient declined export. Driven home by a friend. Advised to call 911 if further symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PUB,Synthroid,none,Hypothyroidism,Syncope after multiple vaccinations as a child - further details unknown,"Seasonal, NKDA","['Dizziness', 'Fall', 'Hyperhidrosis', 'Loss of consciousness', 'Syncope']",1,JANSSEN,IM 1083351,,30.0,M,"5:02p - reaction time; Blood sugar - 169; O2=94; HR 57; BP 110/68; Pt complains dizziness, sweats, no SOB",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/08/2021,0.0,OTH,,,,,,"['Dizziness', 'Hyperhidrosis']",1,JANSSEN,IM 1083355,TX,46.0,F,Sore underarm and shoulder began on the morning of 03/07/2021 and has continued throughout the day on 03/08/2021. The pain is sharp and persistent. I have been taking Tylenol to relieve the pain.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,PHM,"Spironolactone 50 mg daily, multi-vitamin, Vitamin D 1,000 IU, elderberry immune support daily chew",None,None,,None,"['Arthralgia', 'Axillary pain']",1,JANSSEN,SYR 1083360,,60.0,F,"HR-BP; tingling in lips; HR-97- no SOB, no Swelling; O2-97",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/08/2021,0.0,OTH,,,,,,['Paraesthesia oral'],1,JANSSEN,IM 1083362,TX,36.0,F,"Headache, sore arm, injection site pain, low grade fever (100 F), fatigue, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,None,None,None,,Penicillin,"['Fatigue', 'Headache', 'Injection site pain', 'Nausea', 'Pain in extremity', 'Pyrexia']",UNK,JANSSEN,SYR 1083371,TX,74.0,M,"Severe abdominal pain, all night. Sleeplessness all night. All kinds of muscle aches and pain. Heavy breathing.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/24/2021,02/24/2021,0.0,OTH,Too many to list.,"Asthma, Sleepiness, rotator cuff, right; carpal tunnel, left.","Asthma, neuropathy, heart stints, sinusitis.",Flu and pneumonia,"Biaxon. Some foods, not serious.","['Abdominal pain', 'Dyspnoea', 'Insomnia', 'Myalgia']",2,PFIZER\BIONTECH,SYR 1083373,IL,36.0,F,"High fever, weak, inability to stand, soreness, confusion",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,PUB,,None,None,,None,"['Asthenia', 'Confusional state', 'Dysstasia', 'Pain', 'Pyrexia']",UNK,JANSSEN, 1083375,NY,37.0,F,"Joint pain began at 10pm followed quickly by chills. At 1 am on 3/8, fever and increased heart rate (120bpm). Those lasted until 5:30 am. Then I experienced dizziness until 8 am and headache until 2 pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,UNK,"Multi vitamin, vitamin d",None,None,,"Penicillin, tree nuts","['Arthralgia', 'Chills', 'Dizziness', 'Heart rate increased', 'Pyrexia']",1,JANSSEN,IM 1083376,CT,29.0,F,"Initial symptoms of chills and heart racing. Initial HR was 119 with slight dizziness. Reassurance, rest, granola bar. Return to normal HR, BP 02 sat normal, normal CV exam",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PUB,"Vit D, Vit C",No,No,,"PCN, Sulfa","['Cardiovascular evaluation', 'Chills', 'Dizziness', 'Palpitations']",1,JANSSEN,IM 1083382,IL,55.0,F,"15 minutes after vaccine received, patient reports feeling hot in face and then all over body about 1 minute later. Patient reports left sided headache. Patient denies respiratory distress. Patient advised to follow up with primary care provider and to call 911 if symptoms persist or experience respiratory distress. Patient instructed to take Acetaminophen/Ibuprofen, to have food/fluid, and to rest. Pt able to hydrate with water. Patient ambulatory and reports symptoms resolved after 45 minutes. Patient reports able to return to work. Patient declined transportation to hospital for further evaluation. BP132/84, HR 72.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PUB,Xyzal,Not applicable,Not applicable,,Environmental allergies,"['Feeling hot', 'Headache']",1,JANSSEN,IM 1083396,IN,81.0,M,Day after second vaccine woke to complete loss of hearing in left ear. Next day balance was off and still is-and hearing in left ear is still gone.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/17/2021,02/18/2021,1.0,OTH,,,,,,"['Balance disorder', 'Deafness unilateral']",UNK,PFIZER\BIONTECH, 1083397,CT,53.0,F,"Extremely bad headache, exhausted, running a temperature of 99.5 (normal temp. 97.6). Advil did not help symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PVT,"Duexis 800 mg, Ezetimibe 10 mg, Rosuvastatin Calcium 10 mg 3x/week, Bayer, Centrum, 2 D3, Citracal, Zyrtec",none,"cholesterol, plantar fasciitis",,none known,"['Body temperature increased', 'Fatigue', 'Headache']",UNK,JANSSEN,SYR 1083398,TX,35.0,M,"Nothing for the first two hours; malaise and fatigue from hours 2-8 post-vaccination, with a return to vibrancy around 1500 local time. Around 1700, fatigue returned. Took a 3 mile walk between 1700-1800. Consumed two beers @ 7% ABV between 1800-1845. Around 1830 began feeling tingling, chills and muscle and joint pain which continues. The pain is similar to DOMS that occurs after a robust workout; did not have a robust workout today. I'm fully functional, able to eat and able to otherwise function, so the symptoms are manageable.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/08/2021,03/08/2021,0.0,OTH,None,None,"High BMI (68 inches @ 205 lbs), prehypertension",,None,"['Arthralgia', 'Chills', 'Fatigue', 'Malaise', 'Myalgia', 'Paraesthesia']",1,JANSSEN,IM 1083401,CO,50.0,F,"Fever, body chills, muscle spasm, headache Treatment was rest, naproxen, cold pack on neck for fever. Most symptoms subsided by 8 am 3/8/21 except joint pain and flu like muscle ache.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/07/2021,03/07/2021,0.0,PUB,,,,,,"['Headache', 'Muscle spasms', 'Myalgia', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1083406,IL,33.0,M,"15 minutes after vaccine received, patient reports feeling hot and dizzy. Patient denies respiratory distress. Patient advised to follow up with primary care provider and to call 911 if symptoms persist or experience respiratory distress. Patient instructed to take Acetaminophen/Ibuprofen, to have food/fluid, and to rest. Pt able to hydrate with water. Patient ambulatory and reports symptoms resolved after 30 minutes. Patient reports able to return to work. Patient declined transportation to hospital for further evaluation. BP 118/78, HR 64.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PUB,"15 minutes after vaccine received, patient reports feeling hotand dizzy. Patient denies respiratory distress. Patient advised to follow up with primary care provider and to call 911 if symptoms persist or experience respiratory distress. Pa",None,None,,None,"['Dizziness', 'Feeling hot']",1,JANSSEN,IM 1083418,IN,51.0,F,"Chills, body aches, fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,OTH,"Advair, singular, Flonase, simvistatin, beta blocker, various vitamins. Hormone patch.",None,Asthma,,Allergic to Levaquin,"['Chills', 'Pain', 'Pyrexia']",UNK,JANSSEN,IM 1083422,,45.0,F,"Strong headache, mild fever 99.9F, extremely tired, muscle ache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PUB,None,None,None,,None,"['Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,JANSSEN,IM 1083427,CT,38.0,F,"Symptoms of feeling of doom and injection site itching after vaccine was received. No throat swelling, urticaria, hives, no progression of symptoms. Vital signs WNL -HR-90's, BP-140/80, 02 Sat-99%. Persistent dizzy and chills. Transported for evaluation to ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/06/2021,0.0,PUB,"Pantoprazole, PNV",,"Asthma, GERD",,Magnevist dye,"['Anxiety', 'Chills', 'Dizziness', 'Injection site pruritus']",1,JANSSEN,IM 1083428,IL,48.0,F,"1 minute after vaccine received, patient reports feeling mild tongue numbness. Patient denies respiratory distress. Patient given Certirizine 10 mg 1 tab oral. Pt able to hydrate with water. Patient advised to follow up with primary care provider and to call 911 if symptoms persist or experience respiratory distress. Patient instructed to take Acetaminophen/Ibuprofen, to have food/fluid, and to rest. Patient ambulatory and reports symptoms resolved after 30 minutes. Patient reports able to return to work. Patient declined transportation to hospital for further evaluation. BP128/82, HR 84.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PUB,Levothyroxine,Not applicable,Hypothyroidism,,Penicillin,['Hypoaesthesia oral'],UNK,JANSSEN,IM 1083434,CA,48.0,F,EYE FLOATERS AND BLACK DOTES,Not Reported,,Not Reported,Not Reported,,Yes,N,02/10/2021,02/11/2021,1.0,PHM,"LEVOTHYROXINE 75 MCG, VITAMIN D AND C",NONE,HEART MURMUR AND THYROID,,MAXELT,"['Visual impairment', 'Vitreous floaters']",1,MODERNA,SYR 1083440,IL,43.0,M,Around 24 hrs after getting vaccine I started to get dizzy when moving around. The dizziness and Nausea has continued for now 9hrs since started.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,PUB,"Lisinipril, simvastatin, Meloxicam",Did have Covid and my isolation ended 2/8/21,No,,"Sulfa, Azithromycin","['Dizziness', 'Nausea']",1,JANSSEN,IM 1083447,TX,37.0,M,"Headache, high fever (102.5 with Tylenol), violent chills/body shaking, difficulty swallowing, extreme fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,none,none,none,,none,"['Chills', 'Dysphagia', 'Fatigue', 'Headache', 'Pyrexia']",UNK,JANSSEN,SYR 1083452,NY,45.0,F,"Day 1- Fever of 102 F, body aches and pains, chills, Headache Day 2- sore throat and mild aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,"Effexor, Letrazole, magnesium, multivitamin, aspirin, Vitamin D,",,Breast Cancer 4 years ago.,,,"['Chills', 'Headache', 'Oropharyngeal pain', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1083455,MN,31.0,F,"Mild nausea began at approximately 6:30pm, chills and shivering began at approximately 7:15pm. Shivering subsided by 8:30pm, headache and muscle aches persisted. No treatments administered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,Nexplanon implant,Seasonal allergies,None,,None,"['Chills', 'Headache', 'Myalgia', 'Nausea']",1,JANSSEN,IM 1083459,IL,22.0,F,"Janssen COVID-19 Vaccine EUA about 6 hours after Janssen shot I experienced a fever, body aches, chills and nausea throughout the night and through the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,SCH,,,,,,"['Chills', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1083470,TX,32.0,F,"I started feeling fatigue about 2-3 hours after the shot. Body aches started about 5-6 hours after the shot. I feel feverish and have chills, but thermometer registers normal temperature. I am still experiencing all symptoms 8 hours after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,UNK,None,Seasonal allergies,None,,None,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",,JANSSEN,SYR 1083485,NC,18.0,M,"Headache, body aches, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,PHM,None,Patient presented with body aches and pains on Feb 26.. Was tested for COVID-19 as a precaution on Feb 27 and the test was negative. He felt fine by March 2nd. On the vaccination day he felt great.,None,,None,"['Chills', 'Headache', 'Pain']",1,JANSSEN,IM 1083487,TX,28.0,M,Fever and chills,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,OTH,Every night: melatonin and famotadine,None known,Obesity,,None known,"['Chills', 'Pyrexia']",1,JANSSEN,SYR 1083494,MA,30.0,F,"Fatigue, but most interestingly - extreme depression with suicidal thoughts",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,PUB,Insulin,None,Type 1 Diabetes,,None,['Fatigue'],1,JANSSEN,SYR 1083495,AZ,33.0,F,"I don't know if this is related, but reporting just in case. I began losing hearing in my left ear about 2 weeks after receiving my first shot. When it continued to get worse, I went to the dr about 3 weeks after my first shot and was diagnosed with labyrinthitis. My symptoms continued to worsen, and I now have severe hearing loss as well as 75% loss of vestibular function (diagnosed by ENT and audiologist) with constant vertigo. My current diagnosis is labyrinthitis, however I'm also getting an MRI in 2 days to rule out other possibilities.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/10/2021,01/22/2021,12.0,PVT,"Lamictal, montelukast, cetirizine, flovent, multivitamin",,Asthma and environmental allergies,,None,"['Audiogram abnormal', 'Deafness unilateral', 'Full blood count', 'Labyrinthitis', 'Red blood cell sedimentation rate increased', 'Vertigo', 'Vestibular disorder', 'Vestibular function test abnormal']",1,MODERNA,SYR 1083501,UT,82.0,F,"Patient has nausea, vomiting, severe headache and severely increased blood pressure. She reported to the ER where it was determined she had had a stroke.",Not Reported,,Yes,Yes,,Not Reported,N,02/18/2021,02/20/2021,2.0,UNK,,,,,,"['Blood pressure increased', 'Cerebrovascular accident', 'Headache', 'Nausea', 'Vomiting']",UNK,PFIZER\BIONTECH, 1083505,NY,21.0,F,"Chills and shivering that resulted in uncontrollable shaking, extreme full body pains especially in lower back that were debilitating, fever, extreme fatigue and weakness, headache, pain and soreness and injection site. All lasted for approx. 32 hrs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,Doxycycline and Tri-Lo-Sprintec,,,"Yellow Fever Vaccine, extreme body aches and chills, recieved at age 18 on 08/11/2017.",,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Pain', 'Tremor']",1,JANSSEN,IM 1083517,MD,37.0,M,Moderate pain at injection site beginning +6 hours from vaccine. Moderate swelling at injection site for 48 hours from vaccine. Fatigue beginning at +6 hours from vaccine requiring additional sleep and continuing for at least 72 hours. Fatigue results in some periods of moderate weakness and general malaise requiring lying down. Stomach cramps and discomfort.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,UNK,Probiotic (Acidopholis/L. Bacillis) Half a Vitamin B12 supplement,None,None,,None,"['Abdominal discomfort', 'Abdominal pain upper', 'Asthenia', 'Fatigue', 'Hypersomnia', 'Injection site pain', 'Injection site swelling', 'Malaise']",1,JANSSEN, 1083519,NJ,41.0,F,About ten hours after the vaccine I began to get the chills and severe body aches. I also had a low grade temperature. It is now 24 hours since I began feeling this way and I still feel the same. I?ve been taking Advil for the aches and fever.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,PHM,None,,Rheumatoid Arthritis and Lupus,,No,"['Chills', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1083522,FL,35.0,M,"Loss of appetite, headache, chills, feeling lethargic, running nose, sneezing, itchy throat",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,PHM,,,,,,"['Chills', 'Decreased appetite', 'Headache', 'Lethargy', 'Rhinorrhoea', 'Sneezing', 'Throat irritation']",UNK,JANSSEN,SYR 1083543,CO,28.0,F,"Sore at injection site. 5 hours after injection, i had an Increased heart rate, 101 fever, convulsing from the chills, body aches, poor sleep. splitting headache, fatigue, and fever continued to next day. Most symptoms were gone by 48 hours after injection, except soreness around arm. Took ibuprofen to help with symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PUB,Mirena IUD,,,,,"['Chills', 'Headache', 'Heart rate increased', 'Injection site pain', 'Pain', 'Pyrexia', 'Seizure', 'Sleep disorder']",1,JANSSEN,SYR 1083549,LA,65.0,F,"Bleeding and pain at injection site; Droopy left side of face, pain in upper left jaw, below left eye, upper left arm and left shoulder/neck; Transient headache and pain in left leg with ankle swelling.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/04/2021,03/04/2021,0.0,OTH,"Estradiol Transdermal, Tylenol, Miralax, Stool Softener, Fish Oil, Magnesium Malate, Op-Con-A and Lubricant Eye Drops,",,"Fibromyalgia, Ulcerative Colitis, Arthritis,","Seasonal Influenza Vaccine Flucelvax 10/04/2017; 62 yrs,; Adhesive capsulitis","Demerol, Brassica family, Corn, Turkey, Chamomile, Ragweed,","['Arthralgia', 'Facial paralysis', 'Headache', 'Injection site haemorrhage', 'Injection site pain', 'Joint swelling', 'Neck pain', 'Pain in extremity', 'Pain in jaw', 'Periorbital pain']",1,JANSSEN,IM 1083819,MN,29.0,F,"At the time of injection, it was pretty painful and thus sent my body into a shock less than 5 mins after receiving my dose. My vision went white and I was very light-headed and hot/sweaty. A nurse came with me outside to monitor and I was feeling back to normal in 15 minutes. This is something that happens when I experience a high amount of pain, so just reporting for others who maybe have low blood pressure issues. At about 8pm, other side effects started to set in. I first experienced a headache, then experienced soreness/ache-y-ness in my back. Around 8:30, I started to feel light headed again and soon my whole body felt ache-y. I quickly developed chills where I felt so cold that I was uncontrollably shaking and felt very sore/stiff. I have been laying under a heated blanket for the last hour and a half and am finally feeling better with no more shaking or chills. I still have soreness throughout my body and a headache, but I took ibuprofen around 8:30pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/08/2021,03/08/2021,0.0,PUB,Nuvaring (birth control),None,"Low blood pressure(?); I?ve never been told that it?s an issue however. Other than that, none.",,None,"['Back pain', 'Blindness', 'Chills', 'Dizziness', 'Feeling cold', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Musculoskeletal stiffness', 'Pain', 'Tremor']",1,JANSSEN,IM 1083822,TX,33.0,M,"Got on an airplane that evening, while on plane, Severe sweating, chills, blood pressure drop and feeling faint. Fever of 101.9 at 10:15pm. Acetaminophen seems to improve symptoms well.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,PUB,"Vitamin D2, D3",None,None known,,None known,"['Blood pressure decreased', 'Chills', 'Dizziness', 'Hyperhidrosis']",UNK,JANSSEN,SYR 1083827,TX,49.0,F,"Second vax, vax burned when going into arm this time, started feeling tired three hours later. Had a full dinner, went to bed at 10:00. Woke at 4:00 am feeling very achy. Went to kitchen for ibuprofen, took two. Started feeling very nauseated. Went to master bathroom to urinate, and started feeling like I was going to faint. Tried to make it three steps to my small sofa outside bathroom door. That?s the last thing I remember. My husband heard me fall. I had fallen chin first on hardwood floor. He found me lying in a pool of blood. Before going to ER in the next 15 minutes, i had an extreme bout of diarrhea. At ER, I learned that I had Broken both my condyals in jaw and fractured lower mandible. At ER and hospital on 2/2, threw up multiple (about 7-8) times, even with anti-nausea drugs in IV. Doctor put an anti-nausea patch behind my ear but not sure if it helped. Had surgery to set it on 2/3/21.",Not Reported,,Not Reported,Yes,2.0,Yes,N,02/01/2021,02/02/2021,1.0,PVT,Nuva Ring,None,None,,"Chlorhexadine, some penicillin","['Blood test normal', 'Computerised tomogram head abnormal', 'Diarrhoea', 'Dizziness', 'Echocardiogram normal', 'Face injury', 'Fall', 'Fatigue', 'Haemorrhage', 'Injection site pain', 'Jaw fracture', 'Nausea', 'Pain', 'Surgery', 'Vomiting']",2,PFIZER\BIONTECH,SYR 1083830,NJ,36.0,F,"My entire body is shaking. Feels like muscle spasm over my entire body. Slight chills no fever yet. Very sore arm and clenching of stomach, arm, back and shoulders. I took 500 mil of Advil. Shaking starting to stop after 41 min. May be feeling warm I have to check.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,PHM,Subutex,"Smoker, overweight",,,None,"['Abdominal pain upper', 'Chills', 'Muscle spasms', 'Pain in extremity', 'Tremor']",UNK,JANSSEN,IM 1083718,MA,39.0,F,"an internal vibrating tremor inside of her body; flu like symptoms; high blood pressure; insomnia; increase pulse; Dilated pupils; A spontaneous report was received from a healthcare professional concerning a 39-year-old, female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced flu like symptoms, a feeling of an internal vibrating tremor inside of her body/tremor, high blood pressure/increased blood pressure, insomnia, dilated pupil/mydriasis and increase pulse/heart rate increased. The patient's medical history was not provided. No relevant concomitant medications were reported. On 24-Jan-2021, prior to the onset of the events, the patient received the second dose of two planned doses of mRNA-1273 (lot/batch: unknown)on left arm for prophylaxis of COVID-19 infection. On 25-Jan-2021, The patient experienced flu like symptoms, but in the afternoon of the same day she also started to experience an internal ""vibrating"" tremor inside of her body. She had this symptom for 4 weeks now along with high blood pressure, insomnia, dilated pupils and increase pulse. A neurologist told her that it could be an adrenergic hyper response to the vaccine. No Laboratory details provided. Treatment information provided was beta blockers prescribed in the ER visit. Action taken with mRNA-1273 in response to the events is not applicable. At the time of this report, the outcome of the events experienced flu like symptoms, a feeling of an internal vibrating tremor inside of her body, high blood pressure, insomnia, dilated pupil and increase pulse is Unknown.; Reporter's Comments: This case concerns a 39 Y/O F with a serious unexpected event of tremor and NS unexpected influenza like illness, blood pressure increased, heart rate increased, mydriasis, insomnia, and possibly a ""adrenergic hyper response to the vaccine"". Treated with beta blockers. Event onset 2 days after first dose mRNA-1273. Outcome unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/24/2021,01/25/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Blood pressure increased', 'Heart rate increased', 'Influenza like illness', 'Insomnia', 'Mydriasis', 'Tremor']",2,MODERNA,OT 1083719,FL,75.0,M,"AFib; Lightheaded; Pain in the right rear back and couldn't bend over to tie shoes; A spontaneous report was received from a male consumer 75-year-old who experienced, a sore Arm/Pain in Extremity, Afib and lightheadedness. The patient's medical history was not provided. Products known to be used by the patient within two weeks prior to the event was simvastatin, tadalafil, androgel, prevision, magnesium, vitamin D3, vitamin B12, calcium and fish oil. On 04-Feb-2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 Intramuscularly for prophylaxis of COVID-19. On unknown date, the patient experienced sore arm, lightheadness, lasted for 3-4 days and went away. On unknown date, the patients vitals were checked and the heart rate was elevated to 148 and was admitted to the hospital. EKG and pulse rate was irregular. The patient was diagnosed with A fib. Treatment included apixaban, metoprolol and fluids. The patient received both doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome for the events, sore arm, lightheadness and A-fib was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/04/2021,,,UNK,SIMVASTATIN; TADALAFIL; ANDROGEL; MAGNESIUM; VITAMIN B12 NOS; CALCIUM; FISH OIL; VITAMIN D3,,Medical History/Concurrent Conditions: No adverse event (No medical history provided),,,"['Atrial fibrillation', 'Back pain', 'Dizziness', 'Electrocardiogram', 'Heart rate']",2,MODERNA,OT 1083720,,,M,"bell's palsy; A spontaneous report was received from a consumer concerning her husband, a 59- years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed bell's palsy (Facial Paralysis). The patient's medical history included diabetes. Concomitant product use was not provided by the reporter. On 10 FEB 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 004M20A)Intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient developed the event bell's palsy and was considered to be medically significant. No treatment information was not provided. Action taken with mRNA-1273 in response to the event bell's palsy was not reported The outcome of the event bell's palsy was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,,,UNK,,Diabetes,,,,"[""Bell's palsy""]",1,MODERNA,OT 1083721,,,F,"Heart rate dropped into the 30's; A spontaneous report was received from a consumer concerning her mother, a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced decreased in heart rate to 30's. The patient's medical history was not provided. No concomitant medications were provided. The patient received their first of two planned doses of mRNA-1273 (Lot/batch number: unknown) on an unspecified date. On an unspecified date, prior to onset of the events decreased in heart rate to 30's and reaction, the patient received their second of two planned doses of mRNA-1273 (Lot/batch number: unknown) for prophylaxis of COVID-19 infection. On an unspecified date, the patient's heart rate decreased to 30's (medically significant). The patient having to get a pacemaker. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore action taken with the drug in response to the events was not applicable. The event, decreased in heart rate to 30's was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Critical details such as treatment date, the onset date of event, patient's medical history and concomitant medication, hospitalization details including diagnostic results are lacking. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Bradycardia'],UNK,MODERNA,OT 1083722,OH,84.0,F,"Pulmonary embolism; tested positive for covid; A spontaneous report was received from a consumer concerning an 84-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pulmonary embolism, and tested for positive for Covid-19/COVID-19. The patient's medical history included arthritis, and high blood pressure. Concomitant medication history was not provided. On 26-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 12-Feb-21, she started experiencing shortness of breath and went to her local urgent care. They sent her to the emergency room where she was admitted and diagnosed with a Pulmonary Embolism. The patient was prescribed a blood thinner. While in the hospital, she tested positive for Covid-19 on 14-Feb-21. She was in the hospital from 12-Feb-21 to 22-Feb-21. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, pulmonary embolism were recovered. The outcome of the event, COVID-19 was recovering.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Covid-19 is assessed to be unlikely related.",Not Reported,,Not Reported,Yes,11.0,Not Reported,N,01/26/2021,02/12/2021,17.0,UNK,,Arthritis; Hypertension,,,,"['COVID-19', 'Pulmonary embolism']",1,MODERNA,OT 1083723,CA,85.0,M,"general weakness My whole body is ""soft""; He cannot walk; I cannot sit; I can't do anything; A spontaneous report was received from a Consumer concerning an 85 Year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Asthenia, Walking disability, Sitting disability, and Impaired work ability. The patient's medical history was not provided. No Concomitant medications used by the patient was reported. On 25 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. On 26 Feb 2021, the patient was unable to do anything. His whole body was soft and disabled .Also he was not able to sit,walk and do nothing. All the events were considered as medically significant. No Laboratory details were provided. No Treatment details was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were reported as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Yes,U,02/25/2021,02/26/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no relevant medical history provided),,,"['Asthenia', 'Impaired work ability', 'Sitting disability', 'Walking disability']",2,MODERNA,OT 1083724,,31.0,F,"Really bad seizure; A spontaneous report was received from a physician concerning a 31 year old female patient who received Moderna's Covid 19 vaccine(mRNA1273) who developed unusual seizure. The patient's medical history as provided by the reporter included 215Q- 2 copies of a piece of chromosome 15 and the patient was on medications for seizure, sleep disorder and urinary incontinence. Products known to have been used by the patient, within two weeks prior to the event, included daprica, Trazodone, Oxybutynin and Carnitine. On 18-FEB-2021 approximately eight days prior to the onset of symptoms the patient received first of two planned dose of mRNA-1273 (Batch Number 024M20A) for prophylaxis of Covid 19 infection. On25 -FEB-2021 patient had a really bad seizures without the usual triggers. The pulse rate of patient was 89 and came back up.The event was considered as medically significant. The treatment for the event include Valium 5mg. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event really bad seizure was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/25/2021,7.0,UNK,DAPAGLIFLOZIN; TRAZODONE; OXYBUTYNIN; CARNITINE,"Chromosome abnormality (215Q, 2 copies of a piece of chromosome 15.); Overactive bladder; Seizure; Sleep disorder",,,,['Seizure'],1,MODERNA,OT 1083725,MD,,U,"Bell's Palsy; A spontaneous report, was received from consumer concerning a patient of unknown age, gender, race and ethnicity, who was administered Moderna's COVID-19 vaccine, and experienced Bell's Palsy. Patient identifier details was reported as someone from the church. The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reporter stated that the patient was physically and mentally healthy before vaccination. On an unknown date, the patient got the second dose of mRNA-1273 (Lot number: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection. Ona unknown date, after receiving the second dose, the patient experienced Bell's Palsy. Action taken with mRNA-1273 in response to the Bell's Palsy was not applicable. The outcome of the event Bell's Palsy was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.; Sender's Comments: MOD-2021-028166:",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"[""Bell's palsy""]",1,MODERNA,OT 1083726,SD,70.0,F,"Loss of consciousness; Could not think straight; Difficulty walking; Having difficulty speaking; Fast heart beat; Dizziness; Gums began tingling; Gums itching; A spontaneous report was received from a consumer concerning a 70-year-old, female patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and experienced events Loss of consciousness, difficulty in walking (difficulty walking), Mental Impairment(couldn't think straight), Dysarthria(difficulty speaking), Tachycardia(fast heart beat), Dizziness, Paraesthesia oral (gum tingling) and Gingival pruritic(gum itching). The patient's medical history was reported as seizure disorder, diabetic, and allergies. Concomitant medications known to have been used by the patient, within two weeks prior to the event included amlodipine, Aspirin, Benadryl, azosemide, fara sulfate, levothyroxine, losartan, magnesium oxide, metformin, meloxicam, Minoxidil, montelukast , omeprazole, potassium chloride er, primidone, propranolol, rosuvastatin, stool softener, Tylenol extra strength, vitamin D3, voltaren topical gel and tramadol On 25 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010A21A) intramuscularly for prophylaxis of COVID-19 infection. On 25 Feb 2021, the patient experienced the difficulty walking, couldn't think straight, difficulty speaking, fast heartbeat, dizziness, loss of consciousness, gum tingling and gum itching. Laboratory details were not provided. Treatment details was given as Tylenol and Ativan. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event Loss of consciousness was reported as resolved. The outcome of the event, Gait inability, Mental Impairment, Dysarthria, Tachycardia, Dizziness, Paraesthesia and Gingival pruritis were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/25/2021,02/25/2021,0.0,UNK,AMLODIPINE; ASPIRIN (E.C.); BENADRYL 24 D; AZOSEMIDE; FERROUS SULPHATE + FOLIC ACID; LEVOTHYROXINE; LOSARTAN; MAGNESIUM OXIDE HEAVY; METFORMIN; MELOXICAM; MINOXIDIL; MONTELUKAST; OMEPRAZOLE; POTASSIUM CHLORIDE 0.15% + GLUCOSE 5%; PRIMIDONE;,Allergy; Diabetic; Seizure,,,,"['Dizziness', 'Dysarthria', 'Gait disturbance', 'Gingival pruritus', 'Loss of consciousness', 'Mental impairment', 'Paraesthesia oral', 'Tachycardia']",1,MODERNA,OT 1083727,NC,94.0,M,"weakness; Unable to move; So weak he fell over on the carpet; Trembling,tremor; teeth chattering, chills; A spontaneous report was received from a consumer concerning a 94-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced asthenia, disability, muscular weekness, trembling, tremor and chills. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 023L20A) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, at 21:00, patient experienced chills, trembling, weakness, tremor, teeth chattering ,so weak he fell over the carpet and unable to move.At 03:00 am the patient was hospitalized. The reporter also added that the patient usually is a very active for a 94 year old man person .The reporter was worried when the patient was unable to move. On 17 Feb 2021 the patient was discharged from hospital. The events weakness and unable to move were considered as serious. No laboratory details provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. However, patient's advanced age may have been contributory for the event of asthenia.",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,01/20/2021,02/13/2021,24.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no relevant medical history reported),,,"['Asthenia', 'Chills', 'Disability', 'Fall', 'Tremor']",1,MODERNA,OT 1083728,CA,70.0,M,"Dead on the bed with his legs dangling off one side of the bed; Complained about an upset stomach; A spontaneous report was received from a nurse concerning a 70-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273). The patient's medical history included hypertension and diabetes. No concomitant medications were provided. On 20 Feb 2021, Saturday, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection. On 21 Feb 2021, Sunday 9:36 AM the patient's experienced an upset stomach and attributed it to dinner last night and later on 22 Feb 2021, Monday he was found dead on the bed with his legs dangling off one side of the bed. The cause of death was unknown. Treatment information for event upset stomach included half a spoon of an Indian thing. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event upset stomach was fatal and patient died on 21 Feb 2021.; Reporter's Comments: This is a 70-year-old, male patient, who received Moderna's COVID-19 vaccine and history of risk factors for CAD such as hypertension and diabetes, was found dead 2 days after vaccination. Very limited information regarding this events has been provided at this time. Further information has been requested; Reported Cause(s) of Death: Unknown cause of death",Yes,02/22/2021,Yes,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Diabetes; Hypertension,,,"['Abdominal discomfort', 'Death']",UNK,MODERNA,OT 1083729,,,F,"Vaccine administered to 17 year old; A spontaneous report was received from a health care professional concerning a 17-year-old, female patient who received Moderna (mRNA-1273). The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not provided. On unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Treatment for the event was not provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event vaccine administered to 17 year old was considered as recovered.; Reporter's Comments: This case concerns a 17-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1083730,NJ,,F,"Received 2nd vaccine 20 days after the first shot; A spontaneous report was received from a healthcare professional concerning a 45-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) twenty days after the first dose, which was outside of the guidelines. The patient's medical history was not provided. No relevant concomitant medication was reported. On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 026L20A) for prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 038K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 05 Feb 2021, after the vaccination, the reporter analyzed the Agency document and found that the patient had already received the first dose twenty days ago, which was outside of the guidelines. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, vaccination taken twenty days after the first dose, which was outside of the guidelines, was considered unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 026L20A for first dose and lot # 038K20A for second dose) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/16/2021,02/05/2021,20.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Inappropriate schedule of product administration'],1,MODERNA,OT 1083732,AZ,71.0,F,"Swelling; redness; soreness down to the elbow; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 25Jan2021 11:00, at single dose, for covid-19 immunization. The patient has no medical history. Concomitant medications included estradiol (VAGIFEM) and, vitamins. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The vaccine was administered in the hospital. The patient experienced swelling; redness; and soreness down to the elbow - all on 01Feb2021. The patient had not recovered from these adverse events and; no treatment was received for them. The patient has not been tested for COVID-19 since the vaccination. Information about the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/01/2021,7.0,PVT,VAGIFEM,,,,,"['Arthralgia', 'Erythema', 'Swelling']",1,PFIZER\BIONTECH, 1083733,NC,27.0,F,"Exhaustion/fatigue; This is a spontaneous report from a contactable patient. A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247; expiry date: unknown) via an unspecified route of administration in the left arm, on 04Feb2021 at 10:30, at a single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number: EL3247) on 14Jan2021 at 10:45 AM, in the right arm, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. The patient showed a negative nasal swab on 21Jan2021. On 04Feb2021, at 19:00, the patient experienced exhaustion/fatigue. The event was considered non-serious. The patient did not receive treatment for the event. Outcome of the event was recovering. The patient has not been tested for COVID-19 since vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,WRK,,,,,,"['Fatigue', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1083734,MD,40.0,M,"Rash in the back that looks like erythema marginatum, no itch.; Rash in the back that looks like erythema marginatum, no itch.; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EL9262; expiration date: unknown) at vaccination age of 40-year-old via an unspecified route of administration in the left arm on 04Feb2021 13:30 at a single dose for covid-19 immunization. Medical history included mouse allergy, asthma, OSA (obstructive sleep apnea syndrome) and allergy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included fluticasone propionate (FLOVENT) and menthol, methyl salicylate (SALONPAS). The patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EL3247) at vaccination age of 40-year-old via an unspecified route of administration in the left arm on 14Jan2021 14:00 at a single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital. The patient had rash in the back that looks like erythema marginatum with no itch on 04Feb2021. The events were considered as non-serious. The patient did not receive treatment for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/04/2021,0.0,PVT,FLOVENT; SALONPAS [MENTHOL;METHYL SALICYLATE],,Medical History/Concurrent Conditions: Allergy; Allergy to animal; Asthma; Obstructive sleep apnea syndrome,,,"['Erythema marginatum', 'Rash']",2,PFIZER\BIONTECH, 1083736,NY,58.0,F,"double vision; blurred/double vision; This is a spontaneous report from a contactable nurse. A 58-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302 and expiry date: unknown), via an unspecified route of administration on the left arm on 22Jan2021 14:30 at a single dose for covid-19 immunisation. Medical history included elevated B/P. Patient was not pregnant at the time of vaccination. Unspecified medications were received within 2 weeks of vaccination. The patient experienced blurred/double vision on 25Jan2021. Patient had urgent/ emergency care visit for which she was given antibiotics and steroids. She had 2 eye doctors and been to primary doctors twice. Outcome of the events was not recovered. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination on 27Jan2021 (nasal swab: negative).",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/25/2021,3.0,SEN,,,Medical History/Concurrent Conditions: Blood pressure increased,,,"['Diplopia', 'SARS-CoV-2 test', 'Vision blurred']",1,PFIZER\BIONTECH, 1083737,NY,23.0,M,"Fatigue; dizziness; increased hunger; This is a spontaneous report received from a contactable consumer (patient). A 23-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date: unknown), via an unspecified route of administration, on 19Jan2021 10:00, at single dose, for COVID-19 immunization. There was no medical history. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 19Jan2021 at 23:00, the patient experienced fatigue, dizziness and increased hunger. No treatment was given for the events. The patient recovered from the events in Jan2021. The reporter assessed the events as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/19/2021,01/19/2021,0.0,UNK,ZYRTEC,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Dizziness', 'Fatigue', 'Hunger']",1,PFIZER\BIONTECH, 1083738,NY,,F,"her Left arm shoulder pain.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer(patient) reported that a female patient of an unspecified age receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 30Jan2021 on left arm at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. After the dose, patient was injected with cortisone for her left arm shoulder pain. She is asking if it will lessen the effects of the vaccine. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,,,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1083741,CA,49.0,F,"hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; headache; thirst; palpitations; changes to color of extremities; cold/heat intolerance; diuresis; inability to eat; inability to eat or sleep; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female (not pregnant) patient received BNT162B2 (lot number: ek9231) second dose on 06Jan2021 on left arm at single dose for covid-19 immunization. Medical history included hypothyroidism and allergies to penicillin. Concomitant medications in two weeks included levothyroxine sodium (SYNTHROID), liothyronine, magnesium carbonate (MAG 2), trimebutine maleate (MOTRI), zinc, curcuma longa (CURCUMA). The patient previously took BNT162B2 (lot number: ek5730) first dose on 17Dec2020 10:00 AM (age of vaccination was 49-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. On 10Feb2021 07:00 (also reported as 08Feb2021), approximately one month after 2nd vaccine, patient received a steroid epidural with contrast and a day after she had systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep. Not sure if related to vaccine. No COVID prior vaccination. COVID tested post vaccination (Nasal Swab, PCR) on 17Feb2021 and result was Negative. The outcome of the event was recovering. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Hospitalization for 2 days. Patient received symptomatic management as treatment.; Sender's Comments: It is unclear what was the indication for the mentioned 'steroid epidural with contrast ' performed one month after the second dose of BNT162B2. The reported systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep seems attributable to the reported procedure, or the unspecified indication for the procedure, rather than BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/06/2021,02/10/2021,35.0,PVT,SYNTHROID; LIOTHYRONINE; MOTRIC; ZINC; CURCUMA; MAG 2 [MAGNESIUM CARBONATE],,Medical History/Concurrent Conditions: Hypothyroidism; Penicillin allergy,,,"['Decreased appetite', 'Headache', 'Hypertensive crisis', 'Hypoaesthesia', 'Insomnia', 'Mental impairment', 'Nausea', 'Palpitations', 'Paraesthesia', 'Polyuria', 'SARS-CoV-2 test', 'Skin discolouration', 'Temperature intolerance', 'Thirst']",2,PFIZER\BIONTECH, 1083742,,,M,"left side of his face is paralyzed and his left eye will not blink/ he thought he had a stroke/diagnosed with Bell's Palsy/had Bell's Palsy in the past several years ago; left side of his face is paralyzed and his left eye will not blink/ he thought he had a stroke/diagnosed with Bell's Palsy/had Bell's Palsy in the past several years ago; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included that he had Bell's Palsy in the past several years ago. The patient's concomitant medications were not reported. The patient experienced Bell's Palsy after receiving the first dose of the Pfizer Covid 19 vaccine. He stated that the left side of his face is paralyzed and his left eye will not blink. He received the first dose of the vaccine on a Thursday and the following Wednesday he went to the ER because he thought he had a stroke. He was diagnosed with Bell's Palsy, was given medication, and its been a week and his eye still is not blinking. His doctor is uncertain if he should receive the second dose of the vaccine or not. He was asking if he should he get the second dose and how many people were in the study. He also asked if he gets the second dose, if it will make the Bell's palsy worse. Therapeutic measures were taken as a result of event. The outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, and on a positive drug-event temporal association, the Company assessed that a reasonable possibility could not be excluded that the suspect product BNT162B2 contributed to the occurrence of the reported events Bell's palsy and Disease recurrence. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: Bell's palsy,,,"[""Bell's palsy"", 'Disease recurrence']",1,PFIZER\BIONTECH, 1083743,,61.0,F,"Unsure if this reaction could be Osteoarthritis because it is ""symmetrical, definitely a trend of RA""; Unsure if this reaction could be Osteoarthritis because it is ""symmetrical, definitely a trend of RA""; Excruciating joint pain in my body; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 11Feb2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included Sjogren's autoimmune syndrome. The patient's concomitant medications were not reported. In Feb2021, the patient had excruciating joint pain in the body. The patient was unsure if the reaction could be osteoarthritis because it was ""symmetrical, definitely a trend of RA"". The outcome of the events, 'excruciating joint pain in the body', 'osteoarthritis' and 'RA', was unknown. The patient was due to receive the second dose of vaccination on 04Mar2021. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Sjogren's syndrome,,,"['Arthralgia', 'Osteoarthritis', 'Rheumatoid arthritis']",1,PFIZER\BIONTECH, 1083744,FL,72.0,F,"Moderately severe dizziness and nausea; Moderately severe dizziness and nausea; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration at left leg on 19Feb2021 14:00 at single dose for COVID-19 immunization. The patient had allergies to fermented, mold producing foods: cheese, mushrooms and yeast. The patient had other medical history including osteoporosis, hypothyroidism and asthma. The patient is not pregnant. No other vaccine in four weeks. Concomitant medications (medications in two weeks) included levothyroxine and liothirinine. The patient previously received the first dose of BNT162B2 on 20Jan2021 15:00 for COVID-19 immunization. On day four following the second vaccine, on 23Feb2021 10:00, the patient experienced moderately severe dizziness and nausea. She could not move or walk without feeling extremely nauseous and dizzy. There was no treatment for the events. The events were assessed as serious medically significant by reporter. The patient had no COVID prior vaccination and not COVID tested post vaccination. The patient was recovering from the events. Information on lot /batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/23/2021,4.0,UNK,LEVOTHYROXINE; LIOTHYRONINE,,"Medical History/Concurrent Conditions: Asthma; Food allergy (fermented, mold producing foods: cheese, mushrooms, yeast); Hypothyroidism; Osteoporosis",,,"['Dizziness', 'Nausea']",2,PFIZER\BIONTECH, 1083745,CA,39.0,F,"Patient developed right Bells Palsy on 18Feb2021; This is a spontaneous report from a contactable physician. A 39-year-old not pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose on 20Jan2021, first dose on 30Dec2020, both at single dose for COVID-19 immunisation. Facility type vaccine was hospital. Medical history was none. Known allergies was no. If COVID prior vaccination was no. If COVID tested post vaccination was no. If other vaccine in four weeks was no. Other medications in two weeks was no. Concomitant medications were not reported. Patient developed right Bells Palsy on 18Feb2021. AE resulted in emergency room/department or urgent care. AE treatment included prednisone, magnetic resonance imaging (MRI) in Feb2021. The outcome of the event was not recovered. Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, drug causality cannot be completely excluded. Serious Facial paralysis may be considered as late sequel to BNT162B2 injection, due to appropriate chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,02/18/2021,29.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"[""Bell's palsy"", 'Magnetic resonance imaging']",2,PFIZER\BIONTECH, 1083746,PA,21.0,F,"Pericarditis; Transaminitis; This is a spontaneous report from a contactable Other- Health Professional (patient). A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) via an unspecified route of administration on 13Jan2021 15:15 at single dose on left arm, for covid-19 immunisation. Medical history included chronic immune Idiopathic thrombocytopenic purpura (ITP), allergies to Mushroom. The patient did not have covid prior vaccination. The patient's concomitant medications were not reported. The patient experienced pericarditis and transaminitis on 03Feb2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for the events for 6 days. The patient received treatment medications for the events. The lab test included Nasal Swab, covid test: negative on 05Feb2021. The outcome of events was not recovered.; Sender's Comments: Based on the limited information provided, causality relationship cannot be clearly established and cannot be excluded.The case will be reassessed should additional information become available.~ The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,01/13/2021,02/03/2021,21.0,PVT,,,Medical History/Concurrent Conditions: Food allergy; Idiopathic thrombocytopenic purpura,,,"['Pericarditis', 'SARS-CoV-2 test', 'Transaminases increased']",1,PFIZER\BIONTECH, 1083747,MA,,M,"transverse myelitis; Numbness all left side persisted for weeks; Unsteady Gait and difficulty with range of motion for left hand; Unsteady Gait and difficulty with range of motion for left hand; This is a spontaneous report from a contactable consumer. An adult male patient received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at SINGLE DOSE in Left arm for covid-19 immunisation. The patient medical history was not reported. It was unknown if covid prior vaccination. The patient's concomitant medications were not reported. It was unknown If other vaccine in four weeks. It was unknown other medications in two weeks. Since Jan2021, the patient experienced numbness all left side persisted for weeks. Unsteady Gait and difficulty with range of motion for left hand. Cannot open pill bottle with left hand. Diagnosed with transverse myelitis possibly due to vaccine per doctor. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Number of days hospitalization: 3 days. The event outcome was recovering. The patient received treatment for the events. AE treatment: Steroid Infusion. It was unknown if covid tested post vaccination. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,,01/01/2021,,PUB,,,,,,"['Gait disturbance', 'Hand deformity', 'Hypoaesthesia', 'Myelitis transverse']",1,PFIZER\BIONTECH, 1083748,,,F,"lupus flare-ups; bright red face; face is on fire; blood pressure went up high; trembling; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9266), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history included lupus. Concomitant medications were not reported. The patient's doctor told the patient to get the shot. And at 10:15 am after, the patient got a very bright red face. Her face is on fire. The patient thought it was really strange so she went to the paramedics, for which she might have stayed for half an hour. Her blood pressure went soon very high too. She don't have high blood pressure. The patient was also having lupus flare-ups. It happened to her twice last night. Also, last night, her face scrubbed bright red again. Her blood pressure went up high and she started trembling. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Lupus erythematosus,,,"['Blood pressure measurement', 'Burning sensation', 'Erythema', 'Hypertension', 'Systemic lupus erythematosus', 'Tremor']",UNK,PFIZER\BIONTECH, 1083749,LA,64.0,F,"Hallucinations; Anxiety; Paranoia; She was nervous; she wasn't feeling right; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration, first dose on 25Jan2021, then second dose on 13Feb2021 both at single dose on the left arm, for COVID-19 immunisation. Medical history included diabetes mellitus and hypertension, both from an unknown date. Concomitant medication includes taking an unspecified medication for years, pain pills or whatever and the doctor said that it can take up to 7 days to leave the system. On 27Jan2021 at 10:00 am, 2 days after the first dose, it was reported that patient began to have hallucinations, anxiety, and paranoia. On an unspecified date in Jan2021 after the first dose, the patient reported that she was nervous, she is not feeling the same. The events continued after the second dose. She went to the Emergency room on Valentine's day 14Feb2021, she was not admitted and went home the same day. They just told her don't drive and talk to her primary Care Doctor. She then made an appoint for the primary care doctor on 17Feb2021. She has no other vaccines on the same day or in the 4 weeks prior. She has no other family medical history to provide. The outcome of the events hallucinations, anxiety, and paranoia is slowly going down and recovering while for the rest of the events was unknown. Information on lot number/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: Blood pressure high; Diabetes,,,"['Anxiety', 'Feeling abnormal', 'Hallucination', 'Nervousness', 'Paranoia']",1,PFIZER\BIONTECH, 1083750,KY,71.0,M,"passed out; This will drive me nuts all day; I don't feel comfortable walking in my own house; I got up this morning with the feeling of vertigo; getting little worse, worse than they were; This is a spontaneous report from a contactable Consumer. A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number of Covid-19 Vaccine: 592671000-1, Expiry Date of Covid-19 Vaccine: 31May2021, Lot: EL9267), via an unspecified route of administration on 21Feb2021 13:24 at single dose for covid-19 immunisation. The patient medical history were none. Concomitant drug received. Patient stated, ""Yes, I am on Inhalation Pump so, I take it went for one when I need it, I just had that was just little while ago, it wasn't (Incomplete sentence). The patient stated, ""I got my second shot (Covid-19 Vaccine by Pfizer) Sunday about 1:30(13:24 PM) it says on the piece of paper, and I was fine all day Sunday, Monday(22Feb2021), I got up this morning with the feeling of vertigo, which I have had in the years of the past okay, all day, got out of shower from the bathroom out here and get some coffee, and I sat down I went to get up and the vertigo hit and I almost fall over, now I went into the shower and I dropped the wash cloth on the floor, so I went down to pick it up and again almost passed out, almost immediately, and I sat and I get in the kitchen for some toast and I said well let me see what happens here and sat down eating some toast and when I got up to put dirty dishes in the sink, I almost again passed out, now I just got up to get the check I have to write to the gentleman right here who is working for me and just before that I got the same thing now I don't like it, how are these supposed to last, is what I want to know because I can't, this will drive me nuts all day, I can't go anywhere, I can't drive anywhere, yeah I don't feel comfortable walking in my own house. Right now, I have to say I am feeling them getting little worse, worse than they were."" No treatment. Outcome was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/22/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Condition aggravated', 'Gait disturbance', 'Loss of consciousness', 'Vertigo']",2,PFIZER\BIONTECH, 1083751,TN,79.0,U,"was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; Vomiting; Nausea; Chills; Tiredness; Jaw pain; stress on my heart; shortness of breath; no energy; This is a spontaneous report from a contactable consumer (patient). A 79-years-old patient of an unspecified gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number AN5318) , via an unspecified route of administration on 26Jan2021 at single dose for covid-19 immunisation . The patient previously took the first dose bnt162b2 on 05Jan2021for covid-19 immunization at 79-years-old, then experienced headache, chills, jaw pain, tiredness, nausea, vomiting. The patient medical history was not reported. The patient's concomitant medications were not reported. In 2021, the patient have had both the shots of the vaccine (COVID Vaccine) and was still having a lot of symptoms that should not be having like headache, chills, jaw pain, tiredness, nausea, vomiting and patient have had both of them (Both shots) and patient also have been in the hospital with this. The patient had bad jaw pain. The patient had the first shot on 05Jan2021 and had the problems since then and then got the second shot on 26Jan2021 and it got worse. The patient had chills and shortness of breath and after the second shot, the patient landed in the hospital. The physician did several tests. The patient was bleeding, stool was black from blood, and patient was vomiting blood. The patient had stress on heart and did not have a heart attack but had stress on heart. The patient had no energy and cannot breath and it is just that have not energy. The outcome of events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021214946 same patient/drug/event, different dose",Not Reported,,Not Reported,Yes,,Not Reported,U,01/26/2021,,,UNK,,,,,,"['Asthenia', 'Cardiac disorder', 'Chills', 'Dyspnoea', 'Fatigue', 'Haematemesis', 'Haematochezia', 'Haemorrhage', 'Investigation', 'Nausea', 'Pain in jaw', 'Vomiting']",2,PFIZER\BIONTECH, 1083752,CO,73.0,M,"still wasn't feeling too well; Slightly elevated temperature of 98.9; Breathing really fast; Headache; Shivering; This is a spontaneous report from a contactable nurse. A 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), via an unspecified route of administration on 21Feb2021 (about 9:20AM-9:30AM) at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient was vaccinated with the first dose of BNT162B2 on an unspecified date at 73-year-old for COVID-19 immunization. The patient had his second COVID-19 Vaccine yesterday, 21Feb2021 and had a significant reaction. Last night (21Feb2021), about 12 hours later, he started getting a headache, he was breathing really fast, and shivering. He tried to calm himself down and went to bed. This morning (22Feb2021) he got up around 7AM and still wasn't feeling too well. His temperature was slightly elevated at 98.9 on 22Feb2021. His normal temperature is 97.1. He knows his own body and was pretty convinced his reaction was from a slightly elevated temperature and everything that comes with that. He went back to bed this morning and slept until 11:30AM. He got up and felt good. He took his temperature a few minutes ago and it was back to 97.1. The outcome of the events was recovered.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), to reported events cannot totally be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,UNK,,,,,,"['Body temperature', 'Body temperature increased', 'Chills', 'Headache', 'Malaise', 'Respiratory rate increased']",2,PFIZER\BIONTECH, 1083753,AZ,75.0,M,"continues cough, visited or office for flu test and X-ray: Result was mild Pneumonia/viral pneumonia; This is a spontaneous report from a contactable consumer (patient). This is second dose report of two reports. A 75-year-old male patient received the second dose of bnt162b2 (lot: EL 9264), via an unspecified route of administration in left arm on 03Feb2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot: EL3249), at the age of 75-year-old, via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization and experienced COVID-19 (Tested positive 22Jan2021. Jan 24-25 experienced Fever, Diarrhea, Dizzy, Hot/cold periods, Headache, weakness and tiredness). The patient experienced continues cough, visited or office for flu test and x-ray: result was mild pneumonia/viral pneumonia on 05Feb2021. On 05Feb2021 patient was tested for flu. Test was negative, however, an X-ray showed some Pneumonia. Dr. indicated No treatment required. The event required a visit to Physician office. The patient underwent lab tests and procedures which included flu test: negative on 05Feb2021, Pneumonia: positive (viral pneumonia) on 05Feb2021, x-ray: mild pneumonia on 05Feb2021, COVID-19 virus test: positive on 22Jan2021. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106774 Same patient, reporter, drug and different event and dose",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/05/2021,2.0,PUB,,,,,,"['Influenza virus test', 'Investigation', 'Pneumonia viral', 'SARS-CoV-2 test', 'X-ray']",2,PFIZER\BIONTECH, 1083754,,,M,"systemic inflammatory; asymptomatic COVID-19 infection; asymptomatic COVID-19 infection; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient developed a devastating systemic inflammatory response within 36 hours of receiving his second Pfizer vaccine shot. Patient's deadly inflammatory state followed his vaccination. Administration of the Pfizer vaccine ignited a deadly inflammatory response in patient's body acutely, in a setting where he had a recent asymptomatic COVID-19 infection. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of all events were fatal. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: asymptomatic COVID-19 infection; asymptomatic COVID-19 infection; systemic inflammatory",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Asymptomatic COVID-19', 'Drug ineffective', 'Systemic inflammatory response syndrome']",2,PFIZER\BIONTECH, 1083767,,16.0,F,"Under age of 18 were inadvertently given their series of Moderna vaccine; A spontaneous report was received from a nurse concerning a 16-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) under the age of 18 (inappropriate age at vaccine administration). The patient's medical history was not provided. No relevant concomitant medications were reported. On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 012L20A) for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 010M20A) for prophylaxis of COVID-19 infection. The patient under the age of 18 (16 years female) Inadvertently received both doses of Moderna vaccine (inappropriate age at vaccine administration). No adverse reactions were reported. Treatment details if provided or No treatment information was provided. Action taken is not applicable The outcome of the event, patient under the age of 18 was inadvertently given their series of Moderna vaccine was considered recovered.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273, who received both doses (batch number: 012L20A and 010M20A) with no associated AEs. Causality for this medication error is not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Product administered to patient of inappropriate age'],2,MODERNA,OT 1083770,GA,,U,"tachycardia; shortness of breath; sweating; A spontaneous report was received from a other health care professional concerning an unspecified age and gender patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tachycardia, shortness of breath/dyspnea, and sweating/hyperhidrosis. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date at a pharmacy, within minutes, the patient had shortness of breath, tachycardia and sweating. The events were considered to be life threatening. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Yes,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,"['Dyspnoea', 'Hyperhidrosis', 'Tachycardia']",1,MODERNA,OT 1083771,CT,,F,"Spleen infarct; A spontaneous report was received from a physician concerning a 63-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced spleen infarct/splenic infarction. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: unspecified) on first week of January. On 01-Feb-2021, approximately twenty-two days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: unspecified) via an unknown route for prophylaxis of COVID-19 infection. On 23-Feb- 2021, the patient developed spleen infarct and was hospitalized for 2 days. While in the hospital, the patient had a computerized tomography (CT) scan which showed no malignancy. The patient also had a lupus anticoagulation test which showed a mild elevation. Treatment for the event included Synthroid (not specified) The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The event, spleen infarct, was considered recovered on an unspecified date.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/01/2021,02/23/2021,53.0,UNK,SYNTHROID,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Antiphospholipid antibodies', 'Computerised tomogram', 'Splenic infarction']",1,MODERNA, 1083772,,,F,"Fatigue; achy shoulders and neck; achy shoulders and neck; This is a spontaneous report from a contactable consumer. A female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 27Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Jan2021 the patient had Fatigue, achy shoulders, and neck. the patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient been tested for COVID-19 was unknown. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,UNK,,,,,,"['Arthralgia', 'Fatigue', 'Neck pain']",UNK,PFIZER\BIONTECH, 1083774,PA,55.0,F,"dizzy/Dizziness; nausea; This is a spontaneous report from a contactable Other Health Care Professional, the patient. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), via an unspecified route of administration on 02Feb2021 at 07:00 (at the age of 55-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included COVID-19 infection on an unspecified date. The patient was not pregnant at the time of vaccination. Concomitant medications were reported as ""No."" The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Feb2021 at 06:00, the patient experienced dizziness and nausea. The reporter commented that she did not think these were side effects from the vaccine because she got it on Tuesday but her husband pointed out that she normally does not have these side effects, so it has to be from the vaccine. The clinical outcomes of the events dizziness and nausea were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/06/2021,4.0,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Dizziness', 'Nausea']",UNK,PFIZER\BIONTECH, 1083775,PA,,F,"my arm where I had the shot swelled up and was red and was warm to the touch; my upper arm began itching and was red and swollen/my arm where I had the shot swelled up and was red and was warm to the touch; my upper arm began itching and was red and swollen/my arm where I had the shot swelled up and was red and was warm to the touch; my upper arm began itching and was red and swollen; tired; tender; This 72- year-old male patient contactable consumer (reported for himself) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EL9262), via an unspecified route of administration, on 28Jan2021 at 7:00 PM as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a Hospital. She has had no other vaccines on the same day or in the past 4 weeks. Patient has not taken any medications in the past 2 weeks. The patient has no relevant medical history and is not taking any concomitant medications. It was also warm to the touch. On 28Jan2021, it was a little tender. On 29Jan2021, she also reported feeling a little bit tired. On 05Feb2021 at 6:00PM, the patient experienced 8 days after receiving the vaccine in my left arm, my upper arm began itching and was red and swollen. The outcome of the events upper arm began itching and was red and swollen, tired was unknown. The outcome of the event tired was recovered. It was reported that since the vaccination, the patient had been tested for COVID-19 via nasal swab on 05Feb2021 with a negative result.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Allergy,,,"['Fatigue', 'Pain in extremity', 'Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site swelling', 'Vaccination site warmth']",UNK,PFIZER\BIONTECH, 1083776,WI,56.0,F,"injection site swelling, redness, pain; injection site swelling, redness, pain; injection site swelling, redness, pain; This is a spontaneous report from a contactable other health professional. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, intramuscular, in the right arm, on 05Feb2021 10:00 at SINGLE DOSE for covid-19 immunization. Medical history included allergies (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced injection site swelling, redness, pain on 05Feb2021 10:00. The outcome of event was unknown. Patient did not receive any treatment for the events. No follow-up attempts possible. No further information expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/05/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Allergy,,,"['Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH,OT 1083777,WA,60.0,F,"Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9265, via an unspecified route of administration, in the right arm, on01Feb2021 11:30 at SINGLE DOSE for covid-19 immunization. Medical history included diabetes, high cholesterol, high blood pressure and penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced soreness at injection site on 01Feb2021 11:30. The outcome of event was recovered. No follow-up attempts possible. No further information expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/01/2021,02/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure high (High Blood Pressure); Diabetes; High cholesterol; Penicillin allergy,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1083778,,,F,"a little headache; This is a spontaneous report from a contactable consumer (patient). A 92 (units unknown) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced a little headache on an unspecified date. The patient stated that she heard on the news not to take anything after having received the vaccine, ""do not take anything to counteract"". The patient stated that she had a little headache, but she would not consider that an adverse reaction. She stated that she would have had that if she took the flu shot. The patient inquired if what she had heard on the news meant that she could not have any pain medication. She received the second shot of the Pfizer vaccine yesterday. She stated that she heard that on the news and it bothered her. She stated that she would not report this as a side effect/adverse reaction. The clinical outcome of the event a little headache was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Headache'],2,PFIZER\BIONTECH, 1083784,NJ,73.0,F,"Site is very itchy.; Arm red and hot; Arm red and hot; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the left arm on 23Jan2021 at 11:30 AM (at the age of 73 years) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus, asthma, hypertension. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine sodium, hydrochlorothiazide/losartan potassium. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Feb2021 at 16:00 PM, the patient experienced arm red and hot. On an unspecified date the patient experienced the injection site is very itchy. No treatment was given for the events. The clinical outcome of arm red and hot was not recovered. The clinical outcome of injection site is very itchy was unknown. . It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,02/05/2021,13.0,UNK,LEVOTHYROXINE SODIUM; LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE,,Medical History/Concurrent Conditions: Asthma; Blood pressure high; Diabetes,,,"['Erythema', 'Feeling hot', 'Vaccination site pruritus']",1,PFIZER\BIONTECH, 1083786,,42.0,M,"swelling; red spots; tenderness on my right big toe and the toe next to it; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot #: EL3247) via an unspecified route of administration on 19Jan2021 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any known allergies. The patient did not receive any other medications within two weeks prior to the vaccination and did not receive any other vaccines within four weeks prior to the vaccination. On 30Jan2021 the patient experienced swelling, red spots and tenderness on my right big toe and the toe next to it. The clinical course was reported as follows: ""two weeks after my COVID-19 vaccination I noticed swelling, red spots, and tenderness on my right big toe and the toe next to it. I visited my podiatrist who recommended NSAIDs for a week. Today, my sister in law who is a nurse said it looked like COVID toes. When I googled an image of COVID toes, the spots looked identical to my own."" The adverse events required a physician office visit. The patient received treatment for the events which included NSAIDs. The clinical outcomes of the events swelling, red spots and tenderness on my right big toe and the toe next to it were all not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/30/2021,11.0,WRK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: other medical history: None",,,"['Peripheral swelling', 'Rash macular', 'Tenderness']",UNK,PFIZER\BIONTECH, 1083787,IN,51.0,F,"COVID-19 confirmed by positive COVID-19 test; COVID-19; COVID-19 exposure; This is a spontaneous report from a contactable physician (patient). A non-pregnant 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EK5730) on 21Dec2020 at 18:15 (at the age of 51-years-old) intramuscularly in the right arm and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EL1283) on 15Jan2021 at 12:00 (at the age of 51-years-old) intramuscularly in the left arm, both as a single dose for COVID-19 immunization. Medical history was reported as none. It was reported that the patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (other medications in two weeks) were reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination.The patient experienced COVID-19 exposure on 01Feb2021, COVID-19 confirmed by positive COVID-19 test and COVID-19, both on 06Feb2021. It was reported that the patient ""had close contact with COVID-19 positive son on 01Feb21. Now the patient had tested positive for COVID-19 with mild symptoms. The patient became infected more than 2 weeks after the second dose was administered."" The patient was tested for COVID-19 post vaccination on 06Feb2021 and was positive via a rapid antigen nasal swab. It was reported that the patient did not receive treatment for the adverse event. The clinical outcomes of the events COVID-19 confirmed by positive COVID-19 test and COVID-19 exposure were both recovering/resolving.; Sender's Comments: Based on the available information, a causal relationship between events Vaccination failure / COVID-19 and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be completely excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,02/01/2021,17.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['COVID-19', 'Exposure to SARS-CoV-2', 'SARS-CoV-2 test', 'Vaccination failure']",2,PFIZER\BIONTECH,OT 1083788,GA,62.0,F,"Next day repeated sneezing all day every 5 minutes 2 sneezes; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration, in the right arm on 05Feb2021 at 10:00 AM (at the age of 62-years) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included liraglutide (VICTOZA), metformin, lisinopril, bupropion hydrochloride (WELLBUTRIN), rosuvastatin calcium (COLESTRAX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Feb2021, the next day after vaccination, at 2:30 PM, the patient had repeated sneezing all day every 5 minutes 2 sneezes. No treatment was given. The clinical outcome of the sneezing was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,UNK,VICTOZA; METFORMIN; LISINOPRIL; WELLBUTRIN; COLESTRAX,,Medical History/Concurrent Conditions: Diabetes (Diabetes no soleen),,,['Sneezing'],1,PFIZER\BIONTECH, 1083789,,,F,"Laryngitis; This is a spontaneous report from a contactable consumer (the patient). A female patient (Age: 68, Units: unspecified) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration in Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she was scheduled to receive her second shot of the Pfizer vaccine on Thursday. She has laryngitis and received prednisone today. She asked if that was ok to take. She stated it had been two weeks since her first dose, so she didn't think it was because of that. The clinical outcome of laryngitis was unknown. Information on the lot number has been requested.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of laryngitis. The reported event likely represent intercurrent medical condition. There is limited information provided in this report. T his case will be reassessed upon receipt of follow-up information.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,,,UNK,,,,,,['Laryngitis'],1,PFIZER\BIONTECH, 1083790,IA,63.0,M,"Nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). This 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via unspecified route of administration in the left arm on 06Feb2021 at 15:00 (at the age of 63-years-old) as a single dose for COVID-19 immunization. The patient had no medical history, had not been diagnosed with COVID prior to vaccination, and had no known allergies. Concomitant medications included cetirizine hydrochloride (ALLERTEC) from an unknown date for an unknown indication; ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE) from an unknown date for an unknown indication; and ascorbic acid, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iron, lycopene, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium molybdate, sodium selenite, thiamine mononitrate, zinc oxide (ONE A DAY MEN'S 50+ HEALTHY ADVANTAGE) from an unknown date for an unknown indication. The patient had not received any other vaccines in the four weeks prior to administration. On 07Feb2021 at 10:00 the patient experienced nausea and vomiting. No treatment was provided for the events. The clinical outcomes of nausea and vomiting were recovering. It was also reported that the patient had not been tested for COVID since vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/07/2021,1.0,OTH,ALLERTEC; AIRBORNE; ONE A DAY MEN'S 50 + HEALTHY ADVANTAGE,,,,,"['Nausea', 'Vomiting']",1,PFIZER\BIONTECH, 1083792,MI,31.0,F,"my daughter is in labor and they are talking about having to give her a C-section because of, what I believe is a false positive HIV test; had the Covid vaccine last week and she is now in labor; This is a spontaneous report from a contactable consumer (patient's parent). This consumer reported information for both mother and fetus. This is the maternal report. A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunization. Medical history included having a baby two years ago (2019). The patient's concomitant medication was reported as none. The patient received the COVID vaccine on 03Feb2021 and was now (08Feb2021) in labor. The hospital protocol was that they do a rapid HIV test in which the patient has tested positive for, which was further clarified as false positive. They gave her a bag of ATZ (also reported as AVT), an antiretroviral intravenously, tested her again, and was talking about taking the baby by C-section if the rapid test comes back positive again. She was in labor and they have slowed down her labor. They were currently waiting for test results for the other HIV test. The patient has no other risk factors for HIV. Her doctor did not do a routine HIV testing during the pregnancy. She had a baby two years ago and she had an HIV testing done which was negative on an unspecified date. They were trying to find out before they cut her open for no reason. The consumer asked if there has been any information on false positive HIV testing and if the COVID vaccine could possibly cause it as the patient had the COVID vaccine last week. That way, they may less likely to cut the patient open. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021149068 fetal case",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Delivery,,,"['HIV test', 'HIV test false positive', 'Maternal exposure timing unspecified']",1,PFIZER\BIONTECH, 1083794,,,F,"a rash on her legs that's itchy and she still has rash on her legs; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced a rash on her legs that's itchy and she still has rash on her legs on 30Jan2021 with outcome of not recovered. The itching has gone away but the rash is still there. This case was reported as non-serious. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/30/2021,3.0,UNK,,,,,,['Rash pruritic'],1,PFIZER\BIONTECH, 1083795,NJ,,F,"headache; body ache; fatigue; armpit ache; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable other health care professional (patient). A female patient of an unspecified age received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Feb2021 as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the second dose of the Covid19 vaccine on 05Feb2021 and was having symptoms such as headache, body ache, fatigue and armpit ache on unknown date in Feb2021. She wanted to know if she can take acetaminophen (TYLENOL). Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/01/2021,,UNK,,,,,,"['Axillary pain', 'Fatigue', 'Headache', 'Pain']",2,PFIZER\BIONTECH, 1083796,FL,,F,"suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; sore arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-Sponsored Program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on 01Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that she ""had a sore arm, and today she was experiencing all the symptoms of COVID-19"". The clinical outcomes of the events sore arm and suspected COVID-19 with symptoms were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,,,UNK,,,,,,"['Drug ineffective', 'Pain in extremity', 'Suspected COVID-19']",2,PFIZER\BIONTECH, 1083797,CA,79.0,F,"pain; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer-sponsored program. A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 01Feb2021 (at the age of 79-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. The patient experienced pain (reported as not related to the vaccine) on 01Feb2021. The clinical outcome of the event pain was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,,,,,['Pain'],1,PFIZER\BIONTECH, 1083798,OH,,F,"pain in her left arm where the shot was given; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 23Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dose of the vaccine on 23Jan2021 and still had pain in her left arm where the shot was given. The patient's second dose will be on 18Feb2021. The clinical outcome of pain in her left arm where the shot was given was not recovered. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,,,UNK,,,,,,['Vaccination site pain'],1,PFIZER\BIONTECH, 1083799,,,M,"light headache; back pains; This is a spontaneous report from a Pfizer-sponsored program. A contactable Consumer reported similar events for 2 patients. This is 2nd of 2 reports. A male patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Feb2021 as a single dose for covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, she experienced light headache and back pains and would like to know if she can take Tylenol. The clinical outcome of the events headache and back pain was unknown. Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021144697 same reporter, case for Wife",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,,,UNK,,,,,,"['Back pain', 'Headache']",UNK,PFIZER\BIONTECH, 1083801,,,U,"COVID drug reaction with shingles.; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported for self that the patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced covid drug reaction with shingles on an unspecified date with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Herpes zoster'],UNK,PFIZER\BIONTECH, 1083802,FL,,F,"more symptoms and her right eye is more closed; more pain in her head; shingles; This is spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient (Wife) with unknown age (85; Unit: Unknown) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included shingles 4 years before unspecified date and since has neuropathy on head and right eye. The concomitant medications were not reported.Patient had the first dose of the vaccine on 25Jan2021 and are tentatively scheduled for the second dose 24Feb2021, 30 days apart. Patient may have had a reaction to the first dose but it may not be related. Patient experienced shingles in Feb2021. The vaccine seemed to more symptoms and her right eye is more closed and there is more pain in her head in Feb2021. The caller stated they are seriously considering cancelling their second dose. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of headache and eye disorder due to temporal relationship. Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of shingles, which may likely represent intercurrent medical condition. There is limited information provided in this report. This case will be reassessed once additional information is available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,02/01/2021,7.0,UNK,,,Medical History/Concurrent Conditions: Neuropathy; Shingles,,,"['Eye disorder', 'Headache', 'Herpes zoster']",1,PFIZER\BIONTECH, 1083803,,,M,"tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient's child) reported a male patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date a week after receiving BNT162B2, the patient tested positive for COVID-19. The patient had been symptom free for 6 to 7 days at the time of the report. The patient's child wanted to know if it was okay for the patient to get dose 2 of BNT162B2 as he was supposed to get it ""tomorrow."" The outcome of tested positive for COVID-19 was unknown. No follow-up attempts are possible; Information about lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1083804,FL,,F,"arm is sore; arm is swollen; This is a spontaneous report from a contactable consumer (the patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EU283), via an unspecified route of administration on an unknown date as a single dose in the right arm for COVID-19 immunization. Medical history included lung cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unknown date. The patient experienced my arm is still sore, it is swollen on an unknown date stating it is all day, yesterday and the night. The patient treated the arm is sore and swollen with putting an ice pack on it. The clinical outcome of the pain in extremity and peripheral swelling was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: Lung cancer,,,"['Pain in extremity', 'Peripheral swelling']",2,PFIZER\BIONTECH, 1083805,OH,74.0,M,"Pain at the injection site; Body aches; Low grade fever; Chills; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration in the left shoulder area, on 03Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included multivitamin, losartan, eye vitamin and Garlic. The patient previously received first dose of BNT162B2 (lot number: EL3248) on 13Jan2021 for COVID-19 immunization. On an unspecified date, the patient experienced pain at the injection site, body aches, low grade fever, and chills. The patient took ibuprofen as treatment. The events did not require emergency room/ physician visit. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,,,UNK,LOSARTAN,,,,,"['Body temperature', 'Chills', 'Pain', 'Pyrexia', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1083806,NC,83.0,F,"Just my arm, it itches and it is red and got a little fever in it; Just my arm, it itches and it is red and got a little fever in it; Just my arm, it itches and it is red and got a little fever in it; This is a spontaneous report from a contactable consumer (patient). A 83-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration from an unspecified date (at the age of 83 years old) at SINGLE DOSE for COVID-19 immunization, The patient's medical history was not reported. Concomitant medication included unspecified medications but none of them is bothering her. The patient reported that she was not sick, was not running a fever, but her arm is itching and it is red and ""got a little fever in it"" on unspecified date. The consumer inquired ""Should I take some diphenhydramine (BENADRYL) or what should I do? Is that a reaction to the vaccine?"". Outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site warmth']",2,PFIZER\BIONTECH, 1083807,FL,83.0,F,"Soft lump on left side clavicle. Very sore; Soft lump on left side clavicle. Very sore; This is a spontaneous report from a contactable consumer, the patient. A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL5248, second dose) solution for injection intramuscular in the left arm on 16Jan2021 at 11:00 (at the age of 83-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included macular degeneration, glaucoma, and allergies: dairy products, penicillin and sulfa antibiotics. Concomitant medications included ascorbic acid/betacarotene/cupric oxide/tocopheryl acetate/zinc oxide (PRESERVISION), calcium, fish oil and vitamin D. Historical vaccine included BNT162B2 (Lot EL0140, first dose) for COVID-19 vaccination on 26Dec2020 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Feb2021 at 10:00, the patient felt a soft lump on left side clavicle very sore. No treatment was provided for the events sore and lump. The outcome of the events sore and lump was recovering. Since the vaccination, the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/16/2021,02/05/2021,20.0,WRK,PRESERVISION; CALCIUM; FISH OIL; VITAMIN D NOS,,Medical History/Concurrent Conditions: Glaucoma; Macular degeneration; Milk allergy; Penicillin allergy; Sulfonamide allergy,,,"['Mass', 'Pain']",2,PFIZER\BIONTECH,OT 1083808,,26.0,F,"Bicep tendinitis; This is spontaneous report from a non-contactable health professional, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in the left arm on an unspecified date (at the age of 26-years-old) as a single dose for COVID-19 immunization. Medical history was none, and the patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date (within 4 weeks of the second vaccination) for COVID-19 immunization. On 05Feb2021, the patient experienced bicep tendinitis with severe shooting sharp pain when extending the arm and bending over 150 degrees as well as pain which also worsened when twisting the wrist from the facing leg toward the sky. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of bicep tendinitis was not resolved. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,02/05/2021,,MIL,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Tendonitis'],2,PFIZER\BIONTECH, 1083809,OR,,F,"Chills; nausea; intense headache; severe fatigue; muscle pain; joint pain; This is a spontaneous report from a non-contactable nurse (the patient). A 36-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration in the right arm on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the right arm on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unspecified date, the patient experienced chills, nausea, intense headache, severe fatigue, muscle and joint pain that started around 10 following injection and was the worst 24 hours to about 48 hours following injection. Now 53 hours post injection, the patient was feeling close to normal. No treatment was received for the events. The clinical outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow up attempts are possible; information about the lot number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,PVT,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea']",2,PFIZER\BIONTECH, 1083810,NJ,72.0,F,"Chills; Headache; Muscle aches; This is a spontaneous report from a contactable pharmacist. A 72-year-old non-pregnant female patient (reporter's mother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 05Feb2021 at 08:00 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, fibromyalgia, sleep apnea. The patient was not diagnosed with COVID prior to the vaccination. The patient had no known allergies. Concomitant medications included hydrochlorothiazide/valsartan, celecoxib, duloxetine. There were no other vaccines administered within 4 weeks of the vaccination. On 06Feb2021 at 06:00, the morning after the vaccination, the patient experienced chills, headache, and muscle aches. The patient was treated for the events with 600 mg of ibuprofen and the symptoms subsided. Since the vaccination, the patient was not tested for COVID. The clinical outcome of chills, headache, and muscle aches was resolving. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,UNK,VALSARTAN HCTZ; CELECOXIB; DULOXETINE,,Medical History/Concurrent Conditions: Fibromyalgia; Hypertension; Sleep apnea,,,"['Chills', 'Headache', 'Myalgia']",1,PFIZER\BIONTECH,OT 1083811,,,F,"arm started hurting; felt like her throat was closing up; Under her rib cage had a lot of pressure; She was having a hard time swallowing potatoes; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (Solution for injection), via an unspecified route of administration on unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She took the Pfizer COVID19 Vaccine about a week and a half ago. It didn't hurt until two hours later. Then her arm started hurting and that got better. It felt like her throat was closing up. Under her rib cage had a lot of pressure. She was having a hard time swallowing potatoes. It lasted until she went to bed. The next morning it was gone. Should she get the second dose, Maybe the next one will cause her throat to completely close up, She has read Pfizer's could cause tongue and throat swelling. It was on the paper she got. The outcome for the event started hurting is recovering, for she was having a hard time swallowing potatoes was recovered and for other it was unknown. Information on the Lot/Batch Number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Chest discomfort', 'Dysphagia', 'Oropharyngeal discomfort', 'Pain in extremity']",1,PFIZER\BIONTECH, 1083812,CA,,F,"hot cold sweat; hot cold sweat; colds; losing voice; throat is sore; This is a spontaneous report from a Pfizer sponsored program, received from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient experienced colds that results to hot cold sweat and losing voice as her throat is sore. She was due for the second dose on 25Feb2021. The consumer was asking if she could get the second dose of the vaccine on 25Feb2021. She has a terrible cold and is not still over yet. She wanted to get the 2nd dose until she feels better. Outcome of colds was not recovered. Outcome of hot cold sweat, losing voice, throat is sore was unknown. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Aphonia', 'Cold sweat', 'Hyperhidrosis', 'Nasopharyngitis', 'Oropharyngeal pain']",1,PFIZER\BIONTECH, 1083813,,,U,"tested positive between doses 1 and 2 of the vaccine; tested positive between doses 1 and 2 of the vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 6 patients. This is the 6th of 6 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The pharmacist reported that 6 patients tested positive between doses 1 and 2 of the vaccine, in which the pharmacist was giving Covid vaccinations in a nursing home. It was reported that the patient was tested positive between doses 1 and 2 of the vaccine, in which the patient was hospitalized and had received antibodies. And had tested negative upon and continuously since returning to the nursing home. Those patients were tested every day. The pharmacist started administering the second doses. One patient was administered the second dose and then somebody said, ""Oh, they were given antibodies in the hospital''. A fellow pharmacist in which they said, we're under the impression you wait 90 days if they've been given antibodies after that to give the second dose. One of the patients inadvertently received a second dose, not knowing that they received antibody therapy prior to administering the vaccine. The rest who were hospitalized did not receive their second injection. Caller asked, ""What is the policy on antibodies and the second dose? When is the earliest date they can administer that second dose? The individual who was given it inadvertently, should they be given a third injection? Do you give them shot number two or do you start over and give them both shots?'' The outcome of event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported testing with a positive viral load based on the known safety profile. ,Linked Report(s) : US-PFIZER INC-2021199894 same drug/reporter/event, different patient;US-PFIZER INC-2021222955 same drug/reporter/event, different patient;US-PFIZER INC-2021222956 same drug/reporter/event, different patient;US-PFIZER INC-2021222953 same drug/reporter/event, different patient;US-PFIZER INC-2021222954 same drug/reporter/event, different patient",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1083845,CA,47.0,F,"Janssen COVID-19 Vaccine EUA Six hours after the vaccination I experienced an upset stomach, fever, chills, terrible body aches, headache, and sluggishness. I only had children?s Tylenol so I took that but it did not treat the symptoms. Thirteen hours later I took extra strength Tylenol and that helped with the treatment of most of the symptoms. About eighteen hours later I started to feel better. I had residual hot flashes 48 hours later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,Vitamin b and c Magnesium Calcium MSM Probiotic Spirulina/ chlorella,None,None,,Penicillin Macrobid,"['Abdominal discomfort', 'Chills', 'Headache', 'Hot flush', 'Pain', 'Pyrexia', 'Sluggishness']",UNK,JANSSEN, 1083848,MI,77.0,F,"Beginning 2-4(injection date) dull headache on top of head 2-6 vertigo began(room spinning), followed by sinking feeling in head, followed by spasms in center of head felt like seizures. 2-19 hospitalized for CT Scan of Head 2-23 EEG in Doctor Office",Not Reported,,Yes,Yes,2.0,Not Reported,Y,02/04/2021,02/06/2021,2.0,PVT,Nature-Thyroid 97.5mg Atenolol 25mg Amlodipine Besyalate 5mg,none,"Controlled high blood pressure, hypothyroid",,"phenobarbitals, succinylcholine, anectine, steroids","['Computerised tomogram head normal', 'Depressed mood', 'Electroencephalogram normal', 'Headache', 'Seizure like phenomena', 'Vertigo']",2,PFIZER\BIONTECH,IM 1083852,PA,40.0,M,"Fever, chills, extreme muscle pain beginning 12 hours after second dose and lasting 24 hours. Extreme nerve pain in face and head and metallic taste beginning on 3/6 overnight and continuing to worsen over the next 72 hours. Within 48 hours of onset of symptoms, facial paralysis and loss of taste (suspected Bell?s palsy, awaiting confirmation) began in addition to worsening pain and extreme discomfort. Still ongoing.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/23/2021,03/06/2021,11.0,PHM,"Toprol-xl, lexapro, hyzaar, protonix, xiidra",None,"High blood pressure, severe obesity, gerd, depression, anxiety",,None,"['Ageusia', ""Bell's palsy"", 'Blood test', 'Chills', 'Computerised tomogram', 'Discomfort', 'Dysgeusia', 'Facial pain', 'Facial paralysis', 'Headache', 'Myalgia', 'Neuralgia', 'Pyrexia']",2,MODERNA,IM 1083857,IN,67.0,F,"Rec'd 1rst shot @ noon Friday 2/26/21. By Monday afternoon my head started to ache & skin of extremities started stinging, nose running & feeling feverish. My ears started ringing too & got vertigo. Also I started having trouble breathing with a slight ache/pain in my lungs. A noticible itch started in my nose & a tickle in my throat and I had extreme muscle pain, especially in extremities affected by previous carpal tunnel injuries & sciatica. Tuesday afternoon all symptoms were worsening so I used Zicam Gel swabs in my nose, made chicken garlic soup & tea with honey & went to bed. It took 3 days for the sinus, headache & respiratory symptoms to resolve. The neuropathy (skin stinging) pain in my arms, hands & lower legs persists and is very painful.",Not Reported,,Yes,Not Reported,,Yes,N,02/26/2021,03/02/2021,4.0,PVT,"10 mg atorvastatin 5000IU vitamin D-3 Multivitamin, adult mature women's supplement B-complex stress vitamin Nifedipine ointment. 2% Cocoa-zinc oxide suppository",None,"Carpal tunnel both arms & hands TBI survivor, resolved hydrocephalus with Codman-Hakim implanted lumbar peritoneal shunt Low level lumbar neuropathy due to broken sacrum '94",,Prozac Topiramate Fluoxitine Pentazocine lactate,"['Dyspnoea', 'Headache', 'Myalgia', 'Nasal pruritus', 'Neuropathy peripheral', 'Pain in extremity', 'Pain of skin', 'Pulmonary pain', 'Pyrexia', 'Respiratory symptom', 'Rhinorrhoea', 'Sinus disorder', 'Throat irritation', 'Tinnitus', 'Vertigo']",1,PFIZER\BIONTECH,IM 1083882,LA,34.0,F,"Fever, body aches,headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,PHM,"Evikio,klonipin,requip,Edition,,, control",,"Narcalepsy,fibtomyalgia,migraine",,PCN,"['Headache', 'Pain', 'Pyrexia']",UNK,JANSSEN,SYR 1083886,TX,20.0,M,Currently have had a 102.1 fever since around 10:00pm on March 8th 2020.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,UNK,,,,I saw things that weren?t there when I took tamiflu,,['Pyrexia'],UNK,JANSSEN,SYR 1083898,FL,28.0,F,"Severe joint pain in lower back, both hips, both knees, both ankles, left shoulder, left elbow starting from about 10-12 hours after the injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,PUB,Levothyroxine,None,"Hashimoto?s thyroiditis, anemia, chronic migraines.",,"Coedine, sulfa.","['Arthralgia', 'Back pain']",1,JANSSEN,SYR 1083902,TX,54.0,F,Feeling somewhat sick with body aches and fatigue. Restless. Can?t sleep even though I?m tired.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,OTH,Melatonin. Albuterol. Ashwagandha. Gabapentin,Allergies to pollen. High pollen count.,Moderate asthma.,,Eggplant and pork?slight allergy. Pollen. Animal dander. Dust.,"['Fatigue', 'Insomnia', 'Malaise', 'Pain', 'Restlessness']",1,JANSSEN,SYR 1083903,TX,40.0,M,"Fever (101 F), muscle ache, slight headache/sinus pressure in front nasal cavity. Woke from sleeping after feeling feverish and achy at 2:30 AM. Ate a small bite and took 1 500mg Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,WRK,None,None,None,,Ginger,"['Headache', 'Myalgia', 'Pain', 'Paranasal sinus discomfort', 'Pyrexia']",1,JANSSEN,IM 1083904,MD,72.0,M,feeling very tired started about two hours after injection and lasted for two days,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PVT,"nadalol, januvia, vasepa, lisinopril, chlorthalidone. famotidine, levothyroxine, aspirin, magnesium, vit D, B comples, Vit C",none,"CKD, polycythemia, pre diabetes",,none,['Fatigue'],1,JANSSEN,IM 1083905,MN,20.0,F,"100.9 fever, horrible migraine (can't touch chin to neck), chills, sweats, stomach hurts, shivering, body aches, brain zaps, bad neck pain, nauseous Took Tylenol",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,PVT,"Vitamin D, Glucosamine Chondroitin, Multi Vitamin, Sertraline, Levothyroxine, Linzess, Florinef, Loestrin, Carafate, Pantoprazole, Zofran, Famotadine, Vyepti",,"Dysautonomia, Ehlers Danlos Syndrome, Chronic Migraines, Vestibular Migraines, Chronic nausea, Chronic Fatigue, Fructose Malabsorption, POTS, Hashimotos Thyroiditis, IBS, Gastroparesis, Endometriosis",,"Azithromycin, Sulfa, Septra, Cephalon, Sumatriptan, Metronidazole, Latex","['Abdominal pain upper', 'Chills', 'Hyperhidrosis', 'Migraine', 'Nausea', 'Neck pain', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1083917,CA,51.0,M,"Fever, chills, aching palms, hands/fingers, shoulders, burning sensation in feet",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/08/2021,03/08/2021,0.0,PHM,"Ibuprofen, zyrtec, epiduo",,,,,"['Arthralgia', 'Burning sensation', 'Chills', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,IM 1083920,OH,32.0,F,"6 hours after I got the vaccine I started getting a headache, followed quickly by horrible body chills and then horrible body aches. My temperature about an hour later was 105. I took 1000 mg of Tylenol right away and put a cold rag on my head and tried to go to sleep. A couple hours later my fever started breaking, when it was 102.7 I was a sweaty mess and extremely hot and puked a lot. My fever and other symptoms went away within about 7 hours after my fever started breaking.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PUB,Nuvaring,Cold symptoms runny nose sore throat and congestion 1 week prior to getting vaccine,No,,No,"['Chills', 'Feeling hot', 'Headache', 'Hyperhidrosis', 'Pain', 'Pyrexia', 'Vomiting']",1,JANSSEN,IM 1083927,CT,46.0,F,"Headache, stomach pain and chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,PVT,None,None,"Reynauds syndrome, cutaneous lupus, COPD",,Penicillin,"['Abdominal pain upper', 'Chills', 'Headache']",1,JANSSEN,SYR 1083942,CA,24.0,F,"Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Additional Details: Patient fainted 10 minutes after administration of Janssen vaccine. Patient was unconscious for about 15 seconds before regaining consciousness. 911 was called and EMT arrived on scene to monitor's patients blood pressure and blood sugar. Patient still reported lightheadedness so was taken to hospital by EMT/ambulance.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,,,,,,"['Dizziness', 'Hypotension', 'Syncope', 'Unresponsive to stimuli']",1,JANSSEN,IM 1083945,CA,25.0,F,"Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: Patient described feeling nauseas about 10- 15 minutes after vaccination then patient fainted. Patient regained alertness a couple minutes after fainting but was still weak and unable to get up. Paramedics came and patient was found to be hypotensive after 15-20 minutes patients blood pressure restored and she was at full alertness and paramedics signed her release.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,,,,,,"['Asthenia', 'Dizziness', 'Flushing', 'Hyperhidrosis', 'Hypotension', 'Injection site pain', 'Nausea', 'Syncope', 'Unresponsive to stimuli']",1,JANSSEN,IM 1083948,TX,22.0,M,"Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Near fainting episode. Pt did not lose consciousness but blacked out (visual disturbances, tinnitus/temporary hearing loss, nausea) occurred within 2-3 minutes of administration. First attempt to read BP was low (~80/60). Pt is an athlete, so I waited until after water was consumed to take BP again. 2nd reading was ~106/65. Pt felt better after drinking water and after sitting for 15 minutes under observation.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,,,,,,"['Dizziness', 'Hypotension', 'Injection site pain', 'Nausea', 'Tinnitus', 'Tremor', 'Visual impairment']",1,JANSSEN,IM 1083949,CA,26.0,M,"Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient complained of nausea/dizziness followed by blurry vision. He felt like he was going to black out. I took his vitals at 11:43 am and his BP measured 78/53 with a pulse of 45. He was also sweating profusely. The paramedics came within a 5 min time frame and patient was stabilized within 10-15 minutes later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PHM,,,,,,"['Dizziness', 'Dyspnoea', 'Flushing', 'Hyperhidrosis', 'Hypotension', 'Nausea', 'Visual impairment']",1,JANSSEN,IM 1083953,MA,31.0,F,Severe body aches fever w/ chills headache dizziness weakness diarrhea. Motrin for aches and pain water to keep hydrated,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,PVT,None,None,"Asthma,",,None,"['Asthenia', 'Chills', 'Diarrhoea', 'Dizziness', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1083957,TX,51.0,F,"Chills, aches, exhaustion and pain at shot site",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PHM,"Multi vitamin, calcium supplement, eye supplement, vitamin b supplement, Claritin, probiotic and travatan Z eye drops",None,Factor 2&5 Leiden blood clotting disorder Glaucoma,,None,"['Chills', 'Fatigue', 'Injection site pain', 'Pain']",UNK,JANSSEN, 1083958,IA,44.0,M,"Chills, Sweats, Bad body aches Saturday night through Sunday Morning- Took Tylenol Tiredness- throughout Sunday Chills- Sunday night- Tylenol Monday felt good- Monday night slight temp 99.5 and shortness of breath Took Tylenol Tuesday Feel fine headache and slight shortness of breath.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PUB,Allopurinol levothyroxine lisinopril,,,,Slight reaction to ibuprofen,"['Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1083960,MA,25.0,F,"5pm - body aches and fever began 11pm - fever reached 39 degrees Celsius 4am - fever ended, body aches continued headache and some joint pain continued for another full day",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PHM,200mg bupropion daily,none,none,,none,"['Arthralgia', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1083961,VA,27.0,F,"Body aches, joint pain, extreme fatigue, fever (102F)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,OTH,"Vyvanse, Flonase, Sertraline, Trazadone",,,,Codeine - nausea/ vomiting Max alt - skin reaction,"['Arthralgia', 'Fatigue', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1083968,MS,37.0,F,"Vaccine on fri 1pm. Sat had 102 fever, headache. Sun 7pm had possible heart attack symptoms? pain in jaw and from throat to sternum. It went away after giving aspirin so I did not call 911. Monday night 10:30 pm SEVERE headache and severe nausea . Pain on top of head. She said it was unlike any headache in her life. After asprin and tylenol it subsided but she was up for hours with the pain. NOT NORMAL!",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/07/2021,2.0,PHM,"Nvega sustena, zyprexa,buspirone,lithium vistaril",,bipolar,,,"['Chest pain', 'Headache', 'Nausea', 'Oropharyngeal pain', 'Pain in jaw', 'Pyrexia']",1,JANSSEN, 1083974,OH,31.0,F,"Around 8:30p.m. Saturday March 6, 2021 I began to feel chills. I laid down around 9:30p.m to go to sleep. I woke up at 12:25a.m (Sunday March 7th, 2021) with a fever of 104.3 and was experiencing extreme neck and head pain. My hands hurt as if I had arthritis and couldn't make them feel better. I was very short of breath and dry coughing. I took Tylenol and tried to lay back down and was able to go back to sleep around 3:00a.m. I got up at 6:10am and my temp was 101.6. I took Ibuprofen at this point and by 9:30am my temp was 99.8. I was still experiencing a very bad headache and my neck and back were achy. I felt a lot better by about 11:00am, took a hot shower and laid down for a nap around 2:00pm Sunday. When I woke up around 3:15p.m I had spiked yet another fever of 102.0 and was having bad body aches again in my neck and head area and it continued to get worse though my back over the next hour. I was experiencing a dry cough again also but this time it was more constant. It took over 3 hours for my fever to go below 100.0 with alternating Tylenol and Ibuprofen. It finally broke around 7:00p.m. I had a lot of pain in my neck and head the rest of the night. I woke up Monday March 8th, 2021 with a moderate headache but it went away throughout the day. No fever returned Monday. The only time I experienced coughing and shortness of breath was while I had the fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,"YAZ Birth Control, Vitamin B Complex, Vitamin C, Vitamin D, Loratadine (OTC)",,,,Levaquin,"['Back pain', 'Chills', 'Cough', 'Dyspnoea', 'Headache', 'Neck pain', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,SYR 1083976,VA,36.0,M,"High fever over 101.5, chills with significant body shaking, headache, muscle pain",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,OTH,Allegra allergy medicine,No,No,,,"['Chills', 'Headache', 'Myalgia', 'Pyrexia', 'Tremor']",1,JANSSEN,SYR 1083980,TX,18.0,M,"Extreme tiredness, headache, chills, fever. Lasted from 11:30pm until 7am the following day. He?s feeling better now.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Pyrexia']",UNK,JANSSEN, 1083981,NY,49.0,F,"Within one hour: headache, some joint pain Within 7-8 hours: severe joint pain and muscle aches (about 9-10 on scale), fever, chills, vomiting Body pain lasted for 12 hours, next morning pain was lessened but still present , about 5/6 on a 10 scale",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,Stelara Otezla Cholestyramine,Crohn?s disease Psoriasis Elevated liver enzymes/NAFLD,Crohn?s disease Psoriasis Elevated liver enzymes/NAFLD,"After annual flu shot, typical body aches and muscle pain",None,"['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Pyrexia', 'Vomiting']",1,JANSSEN,SYR 1083985,IN,50.0,F,"Fever, Chills, runny nose, diarrhea, muscle and joint ache, extremely tired",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,UNK,none,none,none,,none,"['Arthralgia', 'Chills', 'Diarrhoea', 'Fatigue', 'Myalgia', 'Pyrexia', 'Rhinorrhoea']",UNK,JANSSEN,IM 1083988,IL,23.0,M,"Headache, fatigue, muscle aches, arm where injection occurred is sore",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,OTH,"Pfizer Multivitamin, Biotin, Melatonin, Buproprion XL 150mg, Spironolactone 50mg, Estradiol 2mg",None,,,Azithromycin,"['Fatigue', 'Headache', 'Injection site pain', 'Myalgia']",1,JANSSEN,IM 1084005,NC,75.0,M,"Burning, stinging, sharp pain in anterior upper arm at and distal to the injection site and proximal to the elbow beginning several days after the injection. This is now accompanied by an area of numbness in the same area. The pain symptoms are aggravated by extension of the arm. These symptoms have persisted for the past week or so. I don?t know if they will be permanent. I believe this was caused by injection into a peripheral nerve by injecting too distally into the deltoid. My suggestion is to review proper injection techniques (e.g. location) to all who are giving injections.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/26/2021,02/28/2021,2.0,PVT,None,None,None,,None,"['Injection site hypoaesthesia', 'Injection site pain', 'Pain']",2,PFIZER\BIONTECH,SYR 1084009,KY,72.0,M,"Diagnosed with covid-19; admitted to inpatient hospital; supportive care needed (oxygen, steroids, remdesivir).",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,02/15/2021,02/23/2021,8.0,OTH,,,,,,['COVID-19'],1,PFIZER\BIONTECH,IM 1084011,NC,30.0,M,"I had a feverish episodes, low grade fever of 100.1 degrees Fahrenheit at the highest with some body aches, headache and mild soreness at the injection site. This took place about 5-10 hours after injection and last for about 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,PUB,Sertraline / Zoloft (150mg) Lamotrigine / Lamictal (25mg) Bupropion SR / Wellbutrin (100mg) Advil / Ibuprofen for headaches,Urinary Tract Infection (UTI) in January 2021 but has since cleared up with the help of antibiotics. (Sulfameth/Trimethoprim 800/160mg Tb Sulfameth/Trimethoprim 800/160mg Tb 1 tab for 7 days),None,,None,"['Headache', 'Injection site pain', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1084014,NC,47.0,M,"Janssen COVID-19 Vaccine EUA (3/6) Fatigue began 4 hours after vaccine. (3/6) Severe headache, severe fatigue, moderate fever, mild aches, mild nausea beginning the next day (3/7) and lasting until (3/8). Mild headache and mild fatigue all day (3/8)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,UNK,,,,,,"['Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN, 1084017,,53.0,F,"Body ache a little that day, night time - chills, fever, body aches, next day - all body aches, fever, chills, really tired. Monday - slight body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Fatigue', 'Pain', 'Pyrexia']",UNK,JANSSEN, 1084024,TX,51.0,F,"Fever, dizziness, and weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,OTH,Estradiol,None,None,Shingles vaccination,None,"['Asthenia', 'Dizziness', 'Pyrexia']",1,JANSSEN,SYR 1084036,MS,59.0,F,"Profoundly weak by Saturday the day after the injection (2/6/2021), hospitalized by Monday (2/8/2021), on a ventilator by Wednesday (2/10/2021) and died the following Monday, (2/15/2021) She was treated for HLH (hemophagocyticlymphoistiocytosis)",Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,MIL,,,type II diabetes,,,"['Asthenia', 'Culture negative', 'Death', 'Dependence on respirator', 'Haemophagocytic lymphohistiocytosis', 'Laboratory test normal', 'Mechanical ventilation']",2,PFIZER\BIONTECH,SYR 1084038,KY,35.0,F,"Weakness, cold sweat, nausea, metallic/sour taste in mouth, salivation",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PUB,None,None known,"Inflammation, fibromyalgia",,No known allergies,"['Asthenia', 'Cold sweat', 'Dysgeusia', 'Nausea', 'Salivary hypersecretion']",1,JANSSEN,IM 1084041,CT,38.0,F,"On 3/9/21 woke up with slight injection site swelling, erythema, localized red rash circular about 2x2 inches, very tender with injection site puritus. Took 400mg PO Iburpofen at 0700. 0830am applied caladryl cream and ice compress to the arm. Resembles a smaller "" moderna arm"" type appearance.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/09/2021,3.0,PVT,None,None,None,,No known drug or food allergies,"['Injection site erythema', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Injection site swelling']",1,JANSSEN,IM 1084046,NY,26.0,M,Fever of 100.4 Degrees F. Muscle Swelling/Inflammation throughout body. Fatigue. Vertigo/Dizziness. 3/9 (31 Hours from Vaccination time) Fatigue and inflammation exist throughout body but temperature has normalized to 98.5 Degrees F.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/08/2021,03/08/2021,0.0,OTH,,,,,,"['Dizziness', 'Fatigue', 'Inflammation', 'Muscle swelling', 'Pyrexia', 'Vertigo']",1,JANSSEN,IM 1084058,CT,36.0,F,"Post vaccination feeling of breath doom, walking to door to get fresh air. Syncope, fell to floor. No head injury. Post vaccination syncope, brief generalized tonic-clonic movement followed by emesis. Blood glucose 114, BP 120/80, HR90, O2 Sat 96%.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/06/2021,0.0,PUB,Insulin,,Diabetes,,NKA,"['Dyspnoea', 'Fall', 'Post vaccination syndrome', 'Syncope', 'Tonic clonic movements', 'Vomiting']",1,JANSSEN,IM 1084059,NY,50.0,F,"headache, glassy eyes, fever, chills, full body muscle ache, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,PUB,,,,,,"['Chills', 'Glassy eyes', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",1,JANSSEN,IM 1084063,VA,26.0,F,"Janssen COVID-19 Vaccine EUA About 6 hours after receiving the vaccine: - headache - muscle aches - chills - fever The next day, after receiving the vaccine: - mild headache - mild muscle aches - fever and chills have subsided Immediately after receiving the vaccine and continuing the next day: - sore arm in the arm receiving the injection",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/08/2021,0.0,PUB,"Sprintec, Montelukast, Zoloft Supplements: iron, vitamin C, vitamin B12, vitamin D",none,none,,none,"['Chills', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,IM 1084065,IL,18.0,F,Mother reports same evening patient had 102 fever and body aches. off work/school following day 3/9/21,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/08/2021,03/08/2021,0.0,OTH,Current Outpatient Medications on File Prior to Visit Medication Sig Dispense Refill ? Ibuprofen (ADVIL) 200 MG CAPS capsule Take 200 mg by mouth every 6 hours as needed for Pain �,,,,nka,"['Pain', 'Pyrexia']",1,JANSSEN, 1084069,GA,61.0,F,"Patient had first COVID -MODERNA immunization on 1/6/2021 (chills and fever for one day) and 2/23/2021. Patient began feeling weak, nauseated and dizzy. She was evaluated at the ER on 2/22/2021. She was given fluids and sent home. She continued to feel weak, dizzy and nauseated. She experienced elevated heart rate. She went back to the ER on 2/23/2021. She was diagnosed with atrial fibrillation.",Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,01/06/2021,02/22/2021,47.0,UNK,Xarelto and Protonix,None,H/O DVT x 2,,NKDA,"['Asthenia', 'Atrial fibrillation', 'Chills', 'Dizziness', 'Heart rate increased', 'Nausea', 'Pyrexia', 'SARS-CoV-2 antibody test positive']",UNK,MODERNA, 1084070,OH,78.0,M,"pt states on 2/27/2021 after he got the vax he had a high fever. On 2/28/2021 he was weak and was getting out of the shower when he fell. He was to weak to get up. He stayed on the floor for four hours before he was able to get to a phone to call 911. Paramedics took him to Medical Center he was directly admitted. His temp was 103. He stayed for four days before he was stabilized enough to be able to go home. They ran numerous test, CT, EKG, Labs, Covid (negative). He has a nurse and PT coming to his house 2 times weekly. He states he now how control over his bowels and bladder and can take short walks w/ walker. He has a FU apt w/his PCP on 3/29/2021. He is scheduled for his 2nd Covid dose on 3/25/2021.",Not Reported,,Not Reported,Yes,4.0,Yes,N,02/25/2021,02/27/2021,2.0,OTH,"Mirtazapine 30mg, Propranolol 20mg, Levothyroxine 125mcgm, Fenofibrate 134mg, atorvastatin 40mg, aripiprazole 10mg, latanoprost 0.005% eye drop",no,Depression,,no,"['Asthenia', 'Computerised tomogram', 'Electrocardiogram', 'Fall', 'Laboratory test', 'Pyrexia', 'SARS-CoV-2 test negative', 'Walking aid user']",1,MODERNA,IM 1084075,IL,18.0,M,"Mother reports patient experienced chills and headache, never spiked fever",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/08/2021,03/08/2021,0.0,OTH,,,,,,"['Chills', 'Headache']",1,JANSSEN,IM 1084080,NY,48.0,F,"8 hours of fever, nausea, aches, & headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,UNK,,,,,,"['Headache', 'Nausea', 'Pain', 'Pyrexia']",UNK,JANSSEN,SYR 1084086,TX,50.0,F,High fever and chills for several hours. Headache. Achy.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/01/2021,03/08/2021,7.0,UNK,Soolontra Retinoids,None,None,,None,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1084096,CT,59.0,F,"fever, chills, body aches, headache, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,UNK,"lexapro- 5 mg, vitamin D and multivitamin",no,no,,Sulfa drugs,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN, 1084099,OK,53.0,F,"Within minutes, I felt flushed (sweating, light headed), weak, and arm pain. followed by fatigue, fever, continued pain in my arm, overall weakness, and occasional naseau.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,PVT,Levothyroxine,None,None,,None,"['Asthenia', 'Dizziness', 'Fatigue', 'Flushing', 'Hyperhidrosis', 'Nausea', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,IM 1084105,SC,66.0,M,"received Pfizer dose 1 on 2/27/21 in R deltoid. Approx 2 days later, began having R elbow and forearm cellulitis w/olecranon bursitis. Hospitalized and underwent I&D of R olecranon. Receiving treatment with antibiotic therapy.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/27/2021,03/01/2021,2.0,OTH,"ASA 81mg, fluoxetine, glipizide, metformin, pregabalin",,"DM, anemia, HTN, HLD, heart disease",,"Elavil, statins","['Bursitis', 'Cellulitis', 'Incisional drainage']",1,PFIZER\BIONTECH,IM 1084106,DC,46.0,F,Janssen COVID-19 Vaccine EUA Pain under my left armpit. Pain lasting for longer than 2 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,UNK,Cryselle birth control,None,None,,None,['Axillary pain'],UNK,JANSSEN,SYR 1084113,VA,57.0,F,"7pm chills, fever 102.4, stabbing muscle pain in random places, achey knee joints, rapid heart palpitations, slight headache chills ended around 10pm, fever started to go down at 10:30, palpitations decreased as the fever declined. Tylenol at 7pm, Aleve 10:45pm, Woke the next morning with a headache - drank some water, it has subsided The heart palpitations were concerning",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,UNK,"synthroid, B12, zinc, D3, Biotin, Vit C",,,,"Codine, Dexalant","['Arthralgia', 'Chills', 'Headache', 'Myalgia', 'Palpitations', 'Pyrexia']",1,JANSSEN,SYR 1084119,MD,26.0,F,Janssen COVID-19 Vaccine EUA Side Effects: - Nausea - Head ache - Body aches - Chills - Very sore arm,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,,,,,,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pain in extremity']",1,JANSSEN,IM 1084126,IN,50.0,F,"Immediate rash in chest and face. 20 minutes later entered ER with swollen eye and throat. 14 hours later re-entered ER with rash on chest and face, swollen tongue and throat",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,Magnesium supplement 400mg Lisinopril 10mg Enoxaparin Sodium 40mg Aspirin,Transient ischemic attack Hypertension Antiphospholipid antibody syndrome Migraine variant,Transient ischemic attack Hypertension Antiphospholipid antibody syndrome Migraine variant,,Compazine Doxycycline Nuts Lipitor Almovig Banana,"['Eye swelling', 'Immediate post-injection reaction', 'Pharyngeal swelling', 'Rash', 'Swollen tongue']",1,JANSSEN,UN 1084132,SC,27.0,F,"Nausea, cramping, soreness all over my body, headache, chills and fever. These have lasted so far for 10 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,WRK,Nuvaring,,,,Sulfa drugs,"['Chills', 'Headache', 'Muscle spasms', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1084134,NE,53.0,F,"20 minutes after shot felt stinging in middle of forehead and then quickly followed by numbness tingling ( felt like I had novocaine from dentist) down the left side of my face. 30 minutes after that my throat started to swell; breathing remained okay, so I just self monitored. Throat swelling went down about 10: 00 PM; facial tingling/numbness also got better and is just very slight the next morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,UNK,Estradiol .01% Vag cream 1 x weekly; Celecoxib 50mg 1 x daily; Simvastatin 20 mg 1 x daily; Vit D3 4000 IU daily; asprin 81mg 1 x daily; multivitamin 1 x daily; airborne 1 x daily,none,none,,none,"['Hypoaesthesia', 'Pharyngeal swelling']",1,JANSSEN,SYR 1084135,SC,28.0,F,"Loss of consciousness, irregular heart palpitations, nausea. Loss of consciousness lasted less than one minute, recovery took about twenty minutes to become stable to leave the facility; lingering ?wooziness? throughout the day. This reaction was more likely due to vasovagal syncope than the vaccine. Patient has a history of vasovagal syncope. Arm soreness, fatigue, and headache presented the following day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,SCH,"Emergen-c 3 hours before, magnesium glycinate 220mg twice a day",None,None,,Naproxen sodium,"['Dizziness', 'Fatigue', 'Headache', 'Loss of consciousness', 'Pain in extremity', 'Palpitations']",1,JANSSEN,SYR 1084136,NY,48.0,M,Chest pain and elevated heart rate,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/08/2021,1.0,OTH,"Symbicort, Singulair, Albuterol, Simivastatin",Asthma and MCS (Multiple Chemical Sensitivity),"Asthma, Cholesterol",,Unknown,"['Chest pain', 'Heart rate increased']",UNK,JANSSEN,SYR 1084138,,38.0,F,Unknown vaccine information dose given outside of presenting facility. Facial numbness and droop that began after Janssen COVID vaccine. Patient also with panic attack.,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/06/2021,0.0,UNK,,,,,,"['Facial paralysis', 'Hypoaesthesia', 'Panic attack']",UNK,JANSSEN, 1084141,NY,39.0,M,"body aches, Fever 102, runny nose.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,WRK,"Amlodipine, Symbicort, Topomax, Baby Asprin, Zyrtec, pantoprozole",no,"Asthma, High Blood Pressure",,Zithromax,"['Pain', 'Pyrexia', 'Rhinorrhoea']",1,JANSSEN,SYR 1084145,,96.0,F,At home Care Hospice Patient,Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,,01/28/2021,03/01/2021,32.0,UNK,,,,,,['Death'],2,MODERNA, 1084151,OH,61.0,F,About 12 hours after vaccine I had Uncontrollable shivering and mild body aches. Only lasted about 2 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PUB,"Requip, calcium and glucosamine",None,None,,Penicillin and Ancef Bee stings and poison ivy,"['Chills', 'Pain']",1,JANSSEN, 1084157,OH,63.0,M,Woke up shaking with chills that lasted for about 1/2 hour. Was uncomfortable the rest of night. Got out of bed at 6 am and had a head ache for most of the next day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,UNK,None,None,None,,None,"['Chills', 'Discomfort', 'Headache', 'Tremor']",1,JANSSEN,SYR 1084163,AL,92.0,F,Pt experienced altered mental status and chest pain the day after second vaccine. Pt was transported to Medical Center.,Not Reported,,Not Reported,Yes,1.0,Not Reported,U,03/03/2021,03/04/2021,1.0,PVT,RX for Hypertension,None,Hypertension,,NKDA,"['Chest pain', 'Mental status changes']",2,MODERNA,IM 1084170,VA,54.0,F,"Headache, chills, fever, muscle aches & pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PUB,Multi vitamin; generic brand of Zyrtec,None,None,Felt sick after Shingles vaccine,None,"['Chills', 'Headache', 'Myalgia', 'Pain', 'Pyrexia']",UNK,JANSSEN,IM 1084180,IN,79.0,F,"Patient came with husband to Vaccine clinic today 3/5 for 2nd dose of vaccine. Did well during and immediately after vaccine. Husband states patient has c/o severe chest pressure and pain for several weeks but has refused to come to ER for evaluation. Today, after getting vaccine dose and going to local bank, patient was in passenger side of truck when chest pain started again. Husband begged patient to let him take her to the ER but she said no, I?m fine and I don?t want to go. She then went unresponsive. At a stop light, he was next to a couple of cops who he was able to wave down and proceed to escort them in to ER. Upon arrival to the ER, patient was unresponsive and pulseless. CPR was initiated, 1 defib, and 1mg of epi was given. Return of pulse was obtained, but husband asked for no life support and only comfort measures. Patient was admitted for comfort measures. I do NOT think this was related to her vaccine, but rather the unfortunately end to a sub-acute chest pain patient that declined multiple urgings to seek care. Patient then expired on 3/5/21 at 2037.",Yes,03/05/2021,Not Reported,Yes,1.0,Not Reported,N,03/05/2021,03/05/2021,0.0,PVT,,Coronary Artery Disease; COPD,Coronary Artery Disease; COPD,,Codeine,"['Chest pain', 'Condition aggravated', 'Death', 'Pulse absent', 'Resuscitation', 'Unresponsive to stimuli']",2,MODERNA,IM 1084187,,94.0,F,At Home Care Hospice Patient,Yes,02/18/2021,Not Reported,Not Reported,,Not Reported,,01/30/2021,02/18/2021,19.0,UNK,,,,,,['Death'],1,PFIZER\BIONTECH, 1084194,NY,65.0,F,Sudden loss of earing in left ear - lost all ability to hear. Some hearing has returned after 2 rounds of steroids and an injection of steroids into the ear.,Not Reported,,Not Reported,Not Reported,,Yes,N,01/04/2021,01/06/2021,2.0,PVT,"Calcium, Fosamax 70 m, g colac, , vit D, mulit-vit, , latanoprost each eye",none,osteoporosis,,none,"['Acoustic stimulation tests', 'Deafness unilateral', 'Magnetic resonance imaging', 'Sudden hearing loss']",1,PFIZER\BIONTECH,IM 1084203,AL,65.0,M,"Pt was visiting dr for routine checkup. Pt began to experience difficulty breathing, 911 called. I showed up to pt apneic, pulseless. CPR initiated. Return of spontaneous circulation in ambulance (without Rx). Pt intubated, ventilations continued throughout contact. Pt still had spontaneous pulse upon delivery ti ED, placed on vent in our presence. Pt later transported to Level 1 hospital on vent.",Yes,03/08/2021,Yes,Yes,1.0,Not Reported,N,02/24/2021,03/08/2021,12.0,PVT,unk,unk,unk,Cardiac Arrest,NKDA,"['Apnoeic attack', 'Dyspnoea', 'Endotracheal intubation', 'Heart rate irregular', 'Heart rate normal', 'Mechanical ventilation', 'Pulse absent', 'Resuscitation']",UNK,PFIZER\BIONTECH,IM 1084205,PA,66.0,F,"autoimmune hemolytic anemia & immune thrombocytopenia which worsened rapidly post-vaccine symptoms - bleeding, short of breath, incredibly tired, pale, weak - symptom onset 8 hours post-vaccine rapid progression for first 24 hours post-vaccine) blood transfusion, platelet transfusion, treatment with steroids' (still undergoing treatment and seeing no improvement at this point)",Not Reported,,Yes,Yes,4.0,Not Reported,N,02/16/2021,02/16/2021,0.0,PHM,nexium,,"was diagnosed with covid-19 12/23/2020, previous cancer treatments for ovarian cancer, CBC pre-covid = normal, CBC post-covid on 2/15/2021 low counts in all areas (WBC, WBC, hemoglobin, platelets)",,cats,"['Asthenia', 'Autoimmune haemolytic anaemia', 'Biopsy bone marrow abnormal', 'Dyspnoea', 'Fatigue', 'Haemoglobin decreased', 'Haemorrhage', 'Immune thrombocytopenia', 'Pallor', 'Platelet count decreased', 'Platelet transfusion', 'Transfusion']",1,MODERNA,SYR 1084212,OH,23.0,M,"First vaccine on 1/26/21 began taking three naps a day and arm pain. Given Ibuprofen. Seemed to resolve after 5 days, but continued to nap three times a day sometimes. No fever, but hot flashes at times. Booster given 2/23/21. Began to nap again three times a day or want to stay in his dark room. Began to have a lot of sinus drainage. Gagging at times. Pain over right eye area. Pain in right flank and stomach area. Severe headaches and possible body aches. No fever, but increased and more severe hot flashes that would wake him. 2/28 had a tonic clonic seizure after presenting with a distressed look throughout the day. Slept and upon waking began vomiting until 3am. Was at the ER and given many tests, pain meds and nausea meds. Ruled out kidney stones with CT scan and urinalysis. No fever, but hot flashing continued. ER visit lasted from 2/28/21 through 3/1/21 ER Physician suspects possible reaction to vaccine. Followed up with Neurologist and General Practitioner and both suspect reaction to vaccine.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/23/2021,02/28/2021,5.0,OTH,Fluoxetine; Lamotrigine; Probiotics; Multivitamin; L-Theanine,"No illnesses for over one year. No colds, no fevers and in very good health. No seizures for over 2 years.",autism,Hepatitis/Pertusis/MMR - We stopped at 2 years old suspecting reactions to vaccines. Had physical reactions and regression. auto,Food Sensitivities (dairy and gluten) and Environmental Allergies (grass),"['Abdominal pain upper', 'Blood test', 'Computerised tomogram', 'Eye pain', 'Flank pain', 'Generalised tonic-clonic seizure', 'Headache', 'Hot flush', 'Laboratory test', 'Pain in extremity', 'Paranasal sinus hypersecretion', 'Retching', 'Sleep disorder', 'Urine analysis', 'Vomiting']",2,MODERNA,IM 1084215,CT,44.0,F,"About 9 hours after the Vaccination (Saturday), I had a low grade fever (101), chills, sweats, lethargy, muscle aches, significant headache. These symptoms lasted through the night. Some symptoms lifted (fever) for 6 hours the next day (Sunday) but all other symptoms still present for a full 24 hours following onset. Fever came back again at night (Sunday into Monday) and extreme lethargy the following day (Monday) with dizziness.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,"Motrin, Minastrin (birth control)",none,none,Typhoid,none,"['Chills', 'Dizziness', 'Headache', 'Hyperhidrosis', 'Lethargy', 'Myalgia', 'Pyrexia']",1,JANSSEN,SYR 1084217,NY,58.0,F,"Began to feel achey, chills, headache and slight nausea. Symptoms persisted throughout the day and throughout the night. Symptoms resolved by the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,,,,,sulfa,"['Chills', 'Headache', 'Nausea', 'Pain']",1,JANSSEN,IM 1084223,MN,54.0,F,Janssen COVID-19 Vaccine EUA,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,OTH,"Acidophilus, vitamin d, b-complex, zyrtec, flonase",Seasonal allergies,None,,Latex,['Unevaluable event'],1,JANSSEN,SYR 1084226,MA,40.0,F,"Within 45 minutes lightheaded, within an hour extreme fatigue and chills, ear ache. Several hour after skin hyper sensitivity, nausea. The next day fatigue , nausea and mild cold symptons, migrane.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,PHM,"Zyrtec, multivitamins, glucosomin, butalbital",,"Dust allergies, arthritis",,,"['Chills', 'Dizziness', 'Ear pain', 'Fatigue', 'Hyperaesthesia', 'Migraine', 'Nasopharyngitis', 'Nausea']",UNK,JANSSEN, 1084231,TX,57.0,M,"Patient reports feeling dizzy, lightheadedness, hazzy vision. Declined EMS transport",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PUB,,,hypertension,,,"['Dizziness', 'Electrocardiogram normal', 'Vision blurred']",1,JANSSEN,IM 1084233,IN,51.0,F,"Severe chills, weak, shaky, head pounding and heart racing. Body is sore from the chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,Sulfasalazine,None,"Rheumatoid Arthritis, Psoriatic Arthritis",,None,"['Asthenia', 'Chills', 'Headache', 'Pain', 'Palpitations', 'Tremor']",UNK,JANSSEN,SYR 1084238,TN,55.0,F,"Started running fever of 101 with chills. Body aches, nausea, headache. Blood pressure raised to 148/101 with dizziness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/09/2021,1.0,PHM,"Estradiol, Cardizem, Ambien, Hydrocodone",,,,Seasonal allergies,"['Blood pressure increased', 'Chills', 'Dizziness', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1084243,NY,58.0,F,"Chills, upset stomach, insomnia",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,PUB,"Zoloft, Qvar, Vitamins B,C,D, Magnesium, Citracal, Omega-3, Co-Q10",None,Asthma,,None,"['Abdominal discomfort', 'Chills', 'Insomnia']",1,JANSSEN,SYR 1084250,TX,58.0,F,"Patient reports tingling on face and lips, and headache. Felt better after a few minutes, no flushing or dizziness. Cleared by EMS.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PUB,,,hypertension,,,"['Headache', 'Paraesthesia', 'Paraesthesia oral']",1,JANSSEN,IM 1084252,CA,19.0,M,"Starting 11 hours later, I got a bad headache, chills, my whole body aches, it hurts to move, I can?t sleep",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,SCH,,,,,,"['Chills', 'Headache', 'Insomnia', 'Pain']",1,JANSSEN,IM 1084267,NJ,48.0,M,Dizziness (pretty bad). Nausea satisfying 430am and persists,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,PHM,None,None,None,,None,"['Dizziness', 'Nausea']",1,JANSSEN,IM 1084277,WV,66.0,M,"Chocking sensation, tightness in throat and chest severe enough to make me go to the emergency room of Hospital. I spent the entire weekend in Hospital. I had gotten the vaccine in that same hospital earlier that afternoon. I had a similar reaction with the first dose also given at hospital one month before on Feb 5 ,2021. It was not severe enough to make me go the emergency room. It happened approximately the same amount of time after the vaccination. approximately 12 hours after the shot.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,03/05/2021,03/06/2021,1.0,UNK,bupropion metropronol omeprazole,,,,demerol sulfa,"['Chest discomfort', 'Choking sensation', 'Throat tightness']",2,MODERNA,SYR 1084287,MN,80.0,M,Death,Yes,02/04/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/04/2021,2.0,PVT,,,Diabetes,,,['Death'],UNK,PFIZER\BIONTECH, 1084293,MA,71.0,F,"About 8 hours after getting the shot, I felt tired, then got chills. A couple of hours later, I had diarrhea and nausea with vomiting. This lasted for about 1 hour or so. I became dehydrated and also had a headache. This morning, I seem to be fine - just exhaustion and some headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/08/2021,03/08/2021,0.0,OTH,"Levoxyl; vitamin b, d, k, fish oil; magnesium; probiotic; topical estrogen",Upper chest cough,Osteoporosis,,Topical bacitracin,"['Chills', 'Dehydration', 'Diarrhoea', 'Fatigue', 'Headache', 'Nausea', 'Vomiting']",UNK,JANSSEN,SYR 1084295,MN,41.0,F,"I have a mosquito bite looking mark on my arm from the injection. around 2 pm I had 102.5 fever and I had a headache and felt really tired. I asked the nurse when I went in to get the vaccine if I could get the vaccine if I have already had covid, she said that I could still have the vaccine. The nurse proceeded to vaccine. My boss then told me that she was wrong and that I should not have been given the vaccine if I have already had covid. Is the nurse wrong?",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,vitamin C Vitamin D3,I had Covid; diagnosed 02/15/2021,No,,No,"['Fatigue', 'Headache', 'Pyrexia']",1,JANSSEN,SYR 1084299,IA,37.0,M,"1515-Vaccine administered-Employee was monitored for 15 min and returned to work. 1600- Employee developed hives, reported to occupational health and benadryl administered. APRN present in Occupational Health. Patient stated he felt that his throat was swelling. Epi-Pen was administered while an ambulance was called, employee was transported to ER.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PUB,,,,,Reported no known previous allergic reactions at time of injection.,"['Epinephrine', 'Pharyngeal swelling', 'Urticaria']",1,JANSSEN,IM 1084304,CT,36.0,F,"Fever, Chills, Extreme Fatigue, Sweats, Severe headache, Joint and muscle pain/aches for 24hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PVT,Zyrtec,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Pyrexia']",1,JANSSEN,IM 1084306,ME,69.0,M,My body started shaking uncontrollably - lasted for about 30 to 45 minutes. Also developed a mild headache with the shaking.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,Tamsulosin,None,Interstitial lung disease with autoimmune features,,None,"['Headache', 'Tremor']",1,JANSSEN,SYR 1084314,CO,62.0,F,"Shakes & Chills,Muscle Aches in legs, 101 Fever Fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,Restasis-eye drops Areds-eye vitamins,None,None,,None,"['Chills', 'Fatigue', 'Myalgia', 'Pyrexia', 'Tremor']",1,JANSSEN,IM 1084316,NY,32.0,F,"""Janseen COVID-19 Vaccine EUA"" - experienced following symptoms for 1 day: diarrhea, stomach pain, chills, brain fog/headache, aches throughout my entire body, could barely walk",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,UNK,"antihistamine, flonase, biotin, vitamin d",,,,,"['Abdominal pain upper', 'Chills', 'Diarrhoea', 'Feeling abnormal', 'Gait disturbance', 'Headache', 'Pain']",UNK,JANSSEN,SYR 1084326,ND,73.0,F,"Patient developed ascending paralysis and was diagnosed with transverse myelitis. All work up has been negative for other etiologies. Lumbar puncture performed showing elevated cell count, elevated protein and low glucose.",Not Reported,,Not Reported,Yes,6.0,Yes,N,01/01/2021,02/26/2021,56.0,PVT,Melatonin Diltiazem enoxaparin Hydroxyzine Levothyroxin,Cephalexin Gluten Penicillin Sulfa,HTN HLD Factor V Leiden deficiency c/b PE Hashimoto's thyroiditis,,,"['CSF cell count increased', 'CSF glucose decreased', 'CSF protein increased', 'CSF test', 'Fungal test negative', 'Guillain-Barre syndrome', 'Myelitis transverse', 'Parasitic blood test negative', 'Treponema test negative', 'Viral test negative']",2,PFIZER\BIONTECH,UN 1084338,NY,55.0,M,"Fever/chills and slight nausea overnight (24 hours post-shot). Temperature check is normal, but sweated through night and general malaise 36 hours after shot still. Hot and cold flashes persist 36 hours after.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,OTH,Lamotrigine 200mg and Propanolol 10mg,none,hypertrophic cardiomyopathy,,none,"['Chills', 'Feeling cold', 'Hot flush', 'Hyperhidrosis', 'Malaise', 'Nausea', 'Pyrexia']",1,JANSSEN,SYR 1084343,ID,83.0,F,Rigors and pre-syncope with fall and right hip fracture,Not Reported,,Not Reported,Yes,2.0,Yes,N,03/04/2021,03/06/2021,2.0,PVT,atorvastatin 40mgpoqd,None,None,,None,"['Chills', 'Fall', 'Hip fracture', 'Presyncope', 'X-ray of pelvis and hip abnormal']",2,MODERNA,IM 1084344,IN,57.0,F,"Days 1-2: fast heart rate, difficulty breathing, asthma attack requiring inhaler, muscle weakness. Days 4+: rash at injection site - size of a dime",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/05/2021,03/05/2021,0.0,OTH,,none,asthma (well-controlled),,none,"['Asthma', 'Dyspnoea', 'Heart rate increased', 'Injection site rash', 'Muscular weakness']",UNK,JANSSEN, 1084348,NY,50.0,F,"after leaving facility, while driving home, my left facial cheek began to tingle, then burn. By the time I got home, both my hands and feet also were tingly, like pins and needles falling asleep. The following day, at about 4 PM the tingling, returned to the entire left side of my face, so Monday 03-08-2021 @ 4 PM, from hairline to jaw, tightness, burning and tingling including around my left eye. lasting until roughly 7 PM",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/07/2021,0.0,PUB,"Phentermine, Losartan 25 MG, Vitamin B12, D 50K, Multivitamin, Biotin + Keratin, Fiber gummies, Lactulose, Meloxicam",none,"Type 2 diabetes, hypertension,",,"Shrimp, Rye and Medical tape","['Burning sensation', 'Muscle tightness', 'Paraesthesia']",1,JANSSEN,IM 1084354,MO,38.0,M,"Elevated heart rate, chills, fever, headache, body ache,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,OTH,None,None,None,,None,"['Chills', 'Headache', 'Heart rate increased', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1084368,IN,59.0,M,"Fever, headache, body aches, fatigue ? lasted 6-8 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,No,No,No,,Soy,"['Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN, 1084387,NY,81.0,M,Stroke/ TIA,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/19/2021,02/23/2021,4.0,OTH,amlodipine 5mg omeprazole 20 mg metoprolol succinate 100mg lisinopril 20mg,none,high blood pressure low heart pulse,,none,"['Cerebrovascular accident', 'Computerised tomogram', 'Magnetic resonance imaging', 'Transient ischaemic attack']",2,MODERNA,IM 1084390,NH,88.0,F,"1/29 /21 Increased fatigued, congestion, BP elevated Stat CBC/BMP/CXR. CXR. CXR-CHF with superimposed bilateral infiltrates and bilateral pleural effusions. N.O. Rocephin 1gm IM QD x 7 days. CBC am. Consult with cardiology. 2nd covid vaccine not given. 2/2-2/5 Sent to ER for ongoing significantly elevated BP's. Remains on Rocephin. Hospitalized 3 days for Acute on Chronic Diastolic and Systolic Heart Failure-Diuresed with IV Lasix, Multiple changes in medications by cardiology for poorly controlled HTN. Head CT negative, Covid negative. 2/5 Readmission from Facility-Followed closely by cardiology. Losartan was increased, Hydralazine was increased, Norvasc was increased. Continue Atenolol. Monitoring daily weights and vital signs. Resident with increased lethargy and then behaviors at times, and refusing meds. Oral intake poor. Continued on Coumadin for A-Fib with monitoring of INR. Palliative consult ordered. Continued to be followed by Mental Health and APRN in addition to PCP. 2/6 CBC/BMP/CXR-BUN/Creatinine elevated 44/2.2 and upon readmission to facility. MD changed from Lasix to Demadex. CXR-Continued PNA. Started on Rocephin 1gm IM x 7 days. 2/8 MD visit. Palliative consult ordered 2/11 Critical labs with elevated BUN/Creatine and Na level. MD ofered hospitalization to ADPOA who declined and wanted to pursue Hospice instead. Resident was seen by APRN from Home Health and Hospice Services who discussed plan of care with ADPOA requested comfort care and no further hospitalizations. 2/12 Resident admitted to Hospice Services. Compassionate visit with ADPOA 2/14 resident with further decline, periods of apnea evident, comfort maintained. 2/18 Passed at facility with Hospice services in place and compassionate visits with ADPOA",Yes,02/18/2021,Not Reported,Yes,3.0,Not Reported,N,01/08/2021,01/29/2021,21.0,SEN,1/8/2021 Norvasc 10mg Qam; Atenolol 25mg Qam; Coumadin 2mg QD; Lexapro 10mg Qam; Losartan Potassium 50mg Qam; Micro-K 20meq Qam; Miralaz 17GM Qam; MVI 1tab QD; Oxybutinin Cl ER 5mg Qam; Protonix 40 mg QHS; Senna-S 8.6-50mg 2 tabs QD; Ferro,"Resident with CHF and HTN. On Coumadin for A-FIB, followed by Cardiology. Episodes of increased edema and on daily weights with fluctuations. Lasix adjusted for management. Labs monitored and INR's noted fluctuating and Coumadin doses being adjusted accordingly by MD. Also followed by Mental Health with episodes of increased agitation, weeping and yelling noted. Refusal of medications at times. Medications adjusted by Mental Health as appropriate.","I50.43 ACUTE ON CHRONIC COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE I11.0 HYPERTENSIVE HEART DISEASE WITH HEART FAILURE R53.1 WEAKNESS R26.9 UNSPECIFIED ABNORMALITIES OF GAIT AND MOBILITY R13.12 DYSPHAGIA, OROPHARYNGEAL PHASE I13.0 HYP HRT & CHR KDNY DIS W HRT FAIL AND STG 1-4/UNSP CHR KDNY M15.8 OTHER POLYOSTEOARTHRITIS J18.9 PNEUMONIA, UNSPECIFIED ORGANISM R53.81 OTHER MALAISE J18.8 OTHER PNEUMONIA, UNSPECIFIED ORGANISM K59.00 CONSTIPATION, UNSPECIFIED D68.61 ANTIPHOSPHOLIPID SYNDROME M15.0 PRIMARY GENERALIZED (OSTEO)ARTHRITIS I48.21 PERMANENT ATRIAL FIBRILLATION I70.203 UNSP ATHSCL NATIVE ARTERIES OF EXTREMITIES, BILATERAL LEGS N32.81 OVERACTIVE BLADDER Z79.01 LONG TERM (CURRENT) USE OF ANTICOAGULANTS F32.0 MAJOR DEPRESSIVE DISORDER, SINGLE EPISODE, MILD E26.1 SECONDARY HYPERALDOSTERONISM N18.4 CHRONIC KIDNEY DISEASE, STAGE 4 (SEVERE I50.42 CHRONIC COMBINED SYSTOLIC AND DIASTOLIC HRT FAIL F03.91 UNSPECIFIED DEMENTIA WITH BEHAVIORAL DISTURBANCE E78.2 MIXED HYPERLIPIDEMIA R41.3 OTHER AMNESIA M25.551 PAIN IN RIGHT HIP M79.81 NONTRAUMATIC HEMATOMA OF SOFT TISSUE R42 DIZZINESS AND GIDDINESS M54.5 LOW BACK PAIN F41.9 ANXIETY DISORDER, UNSPECIFIED",,Zyprexa,"['Abnormal behaviour', 'Apnoea', 'Atrial fibrillation', 'Blood creatinine increased', 'Blood pressure increased', 'Blood sodium increased', 'Blood urea increased', 'Cardiac failure acute', 'Cardiovascular evaluation', 'Chest X-ray abnormal', 'Computerised tomogram head normal', 'Condition aggravated', 'Death', 'Decreased appetite', 'Fatigue', 'Full blood count', 'Full blood count increased', 'General physical health deterioration', 'Hypertension', 'Hypophagia', 'International normalised ratio', 'Lethargy', 'Lung infiltration', 'Metabolic function test abnormal', 'Pleural effusion', 'Pneumonia', 'Respiratory tract congestion', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 1084398,NY,36.0,F,"Whole body ache, severe chills, body warm to the touch, nausea/vomiting, headache (lasted from 9 at night to around 3 in the morning) Body ache (for about 3 days) Diarrhea and nausea (lasted about 3 days) Sore arm at injection site (Going on day 4)",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,SCH,Lexapro Tylenol,,Migraines,,Penicillin,"['Chills', 'Diarrhoea', 'Headache', 'Injection site discomfort', 'Nausea', 'Pain', 'Skin warm', 'Vomiting']",1,JANSSEN,SYR 1084401,,28.0,F,"Low grade fever, muscle aches, chills lasted until about midnight. Felt fine next morning",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,UNK,None,None,None,,None,"['Chills', 'Myalgia', 'Pyrexia']",1,JANSSEN,IM 1084412,SC,53.0,F,"Immediate lips/tongue tingling, right neck started to hurt, had benadryl 50mg po, progressively worse, trouble clearing throat, had epi and IM benadryl and sent by EMS to hospital, SOB, wheezing, EC- epi, Decadron, admitted and then intubated and had epi infusion.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,03/05/2021,03/05/2021,0.0,PVT,"Metformin, crestor, gabapentin, vitamin d, citalopram, singulair, meloxicam, lasix, potassium, trujio, insulin, novolog","On oxygen for post covid, pulmonary hypertension from covid",Diabetes,,"mushrooms, codeine, tetracycline, zithromax, ancef, sulfa, levimir, myrbetric","['Dyspnoea', 'Endotracheal intubation', 'Immediate post-injection reaction', 'Neck pain', 'Paraesthesia oral', 'Throat irritation', 'Wheezing']",1,PFIZER\BIONTECH,IM 1084418,IN,56.0,F,"Chills, fever, aches lasting 48 hrs",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,UNK,Levythyroxine .1,N/a,"Asthma, low thyroid",,"Sulfa, pain meds","['Chills', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1084419,ME,61.0,M,"EMS reported sudden onset of shortness of breath, patient grabbed his chest and collapsed. He stopped breathing. Wife began CPR with chest compressions at 5:00. Fire dept. arrived resumed CPR and attached AED but there was no shock advise. They placed an OPA as well (inserted an airway) and started ventilation. Asystole was confirmed, they continued CPR. After 5:25 they gave 3 rounds Epineferin and ended CPR at 5:46. They also checked his blood sugar and it was 136. Possible reaction to covid vaccine. Possible death due to history of cardiac issues. His PCP is requesting an autopsy",Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,PVT,Metformin Glipizide Metoprolol,"Shortness of breath for a week before his passing, he did not seek medical attention for this.",Cardiac History Hypertension Diabetes,,No,"['Airway patency device insertion', 'Blood glucose increased', 'Cardiac arrest', 'Cardiac assistance device user', 'Cardiac disorder', 'Condition aggravated', 'Death', 'Dyspnoea', 'Mechanical ventilation', 'Respiratory arrest', 'Resuscitation', 'Syncope']",1,MODERNA,SYR 1084420,IL,51.0,M,Patient vaccinated. Shortly after patient complained of itchiness in throat. A focused exam was gone on the patient. No noted swelling in patients oral cavity. Patient able to talk and swallow. Patient given 10mg of cetirizine. Patient states that itchiness resolved during observation period. Patient refused further treatment and decided to return to work.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,Patient stated that he was on hypertensive medication. Patient was not sure of medication name.,Hypertension,Hypertension,,Patient stated being allergic to bee stings. Patient reported anaphylactic response to be sting.,['Throat irritation'],1,JANSSEN,IM 1084421,WA,78.0,F,"This was an administration error, drawn into syringe and not given. patient had no visible symptoms.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PHM,"metoprolol, potassium Cl, lipitor, alendronate, plavix, gabapentin, protonix",,"hypertension, anemia, hyperlipidemia, osetoporosis, breast cancer",,,"['Product administration error', 'Unevaluable event']",1,JANSSEN,IM 1084427,NC,63.0,F,Patient reports having slurred speech beginning 2000 the evening following vaccination. She presented to the ER on 02/11/2021 and admitted to hospital for Acute CVA. Discharged on 02/14/2021. Patient's PCP recommended completion of series.,Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,02/10/2021,02/10/2021,0.0,PUB,Unkown,Unknown,Afib,,Denies,"['Cerebrovascular accident', 'Dysarthria']",1,PFIZER\BIONTECH,IM 1084431,IN,56.0,F,"Migraine, chills, diarrhea, vomiting, sore muscles, fatigue. Weak",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,OTH,"Imitrex, sythroid, celexa,lipitor, and kempra",None,"Ibs, thyroid disease, seizure disorder.",Dpt,"Sulfa, penicillin antibiotics","['Asthenia', 'Chills', 'Diarrhoea', 'Fatigue', 'Migraine', 'Muscle discomfort', 'Vomiting']",1,JANSSEN,SYR 1084439,NJ,,U,"Large portion of dose leaked out; A spontaneous report was received from a healthcare professional (pharmacist) concerning a unknown age of unknown gender patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced large portion of dose leaked out. The patient's medical history, was not provided by the reporter. Concomitant medications were not reported. On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On unknown date , the patient reported large portion of dose leaked out. Treatment for the events were not reported. Action taken with mRNA-1273 in response to the events was not reported. The events,large portion of dose leaked out was considered unknown.; Reporter's Comments: This report refers to a case of inappropriate dose administered for mRNA-1273 (Lot number: unknown) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PHM,,,Medical History/Concurrent Conditions: No adverse event,,,['Incorrect dose administered'],UNK,MODERNA,OT 1084440,CA,,F,"Received an expired vaccine dose; A spontaneous report was received from a Consumer concerning a 60-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced received an expired vaccine dose. The patient had no adverse event in the medical history. No relevant concomitant medications were reported. On 13 Feb, 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 043L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 23 Feb 2021, the patient was acknowledged by her neighbor that her neighbor received expired vaccine dose. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, received an expired vaccine dose, was resolved on 13 Feb 2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # 043L20A) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Expired product administered'],1,MODERNA,OT 1084443,IL,52.0,F,"Body aches, headache , fatigue, sore throat,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,WRK,"Pantoprazole, montelukast, Synthroid, vitamin D",,None,,,"['Fatigue', 'Headache', 'Oropharyngeal pain', 'Pain']",1,JANSSEN,SYR 1084444,MN,78.0,M,Exacerbation of myasthenia gravis that had been stable for 10 years. Increasing weakness and respiratory difficulties within 72 hours of vaccination. Required intubation and mechanical ventilation which continues,Not Reported,,Yes,Yes,7.0,Not Reported,N,02/03/2021,02/23/2021,20.0,PVT,"acetaminophen (TYLENOL) 500 MG tablet Take 500-1,000 mg by mouth every 6 hours as needed for mild pain or pain Unknown, Entered By History Needs Review calcium carbonate 600 mg-vitamin D 400 units (CALTRATE) 600-400 MG-UNIT per tablet Take","Myasthenia gravis, hypertension",Myasthenia gravis,,"Ciprofloxacin, Procainamide, Quinidine, Quinine","['Asthenia', 'Blood gases', 'Chest X-ray', 'Computerised tomogram thorax', 'Condition aggravated', 'Endotracheal intubation', 'Mechanical ventilation', 'Myasthenia gravis', 'Respiratory disorder']",1,PFIZER\BIONTECH,IM 1084449,MD,92.0,M,"Per the EUA, cases of COVID-19 vaccination that result in hospitalization or death are to be reported. This patient received Moderna on 3/4 and 2/4. Patient is admitted for left pontine acute infarction ?",Not Reported,,Not Reported,Yes,2.0,Not Reported,,03/04/2021,03/07/2021,3.0,PVT,,,,,,['Brain stem infarction'],2,MODERNA,IM 1084453,NY,66.0,F,Approximately 12 hours after the vaccine I developed a headache and became VERY tired. Approximately 14 hours after the vaccine I developed a fever. As of 9:00 am everything is back to normal.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,UNK,"Montelukast, Metformin, Pot Chlor Er, Omeprazole, Amitriptyline, Sotalol, Fluoexetine, Torsemide, Vitamin D, Vitamin E & Goli",,"Heart Disease, Liver Disease, High Cholesterol, Diabetes Type II, Gout, Anemia",,,"['Fatigue', 'Headache', 'Pyrexia']",1,JANSSEN,IM 1084454,IA,65.0,F,"headache, nausea, aching, chilling",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,"zyrtec, 8hr arthritis pain relief, centrum minis women 50+, hair, skin & nails gummies, ginkgo biloba extract 120 mg",none,none,,none that I am aware of,"['Feeling cold', 'Headache', 'Nausea', 'Pain']",UNK,JANSSEN, 1084462,IL,40.0,F,"Patient stated that her heart was racing and her feeling shaking in her limbs. Vitals were BP 135/80, HR 90, RR.14. Patient denied any other symptoms. After about 15 minutes patient stated that she felt better, Denies any medical history and instructed to follow up with her PCP. Patient stated that she wanted to return to work and denied any further medical treatment.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,,,,,PENICILLIN,"['Palpitations', 'Tremor']",1,JANSSEN,IM 1084464,IL,28.0,F,"Janssen COVID-19 Vaccine EUA. Injection site on arm hurt immediately after injection and upper arm is still sore today (3 days later). Approx 7 hours after receiving vaccine I experienced a sudden onset of overall body aches and joint pain specifically in my knees. It was kind of severe- even my skin was hurting when I got goosebumps. A fever came on after that and I was shivering, cold, sweaty. Approx 11 hours after injection I began to experience a severe headache and sleepiness. Symptoms continued overnight and disturbed my sleep, but were relieved somewhat by taking ibuprofen. By the next morning (after sleeping 14 hours) I was only feeling tired, arm soreness, and headache (no more fever, chills, body aches). All symptoms except arm soreness cleared up rather suddenly, approx 24 hours after they came on (which was approx 31 hours after injection).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,Levora- birth control pill,none,none,,none,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Injection site discomfort', 'Injection site pain', 'Limb discomfort', 'Nasopharyngitis', 'Pain', 'Pyrexia', 'Sleep disorder', 'Somnolence']",1,JANSSEN,SYR 1084473,FL,42.0,M,"Approximately 10 hours after receiving the injection, I experienced extreme chills, nausea, elevated heart rate. The last time I experienced symptoms like this was on the first day I started chemotherapy and had an allergic reaction to one of the chemo drugs (bleomycin). I had a delayed reaction hours later and went to the ER. It was determined it was an allergy. So I took Claritin D 24 H and saw the symptoms I was experiencing last night dissipate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,UNK,"Descovy, Claratin D 24H, testosterone cyphonate",,Formerly stage 4 cancer,,Bleocycin,"['Chills', 'Heart rate increased', 'Hypersensitivity', 'Nausea']",1,JANSSEN,SYR 1084477,NC,48.0,M,"Fever 101, severe aches, swelling of face, fast heartbeat, bad rash all over body, dizziness and weakness, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/08/2021,03/08/2021,0.0,PVT,Gabapentin Lexapro Atorvastatin,None,Covid September 2020,,,"['Asthenia', 'Dizziness', 'Headache', 'Heart rate increased', 'Pain', 'Pyrexia', 'Rash', 'Swelling face']",1,JANSSEN,IM 1084482,FL,48.0,F,"J&J vaccine around 8:40am Saturday. By 3pm, I was feeling significant fatigue. By 5pm, chills and low fever (99). Chills and fever intensified, and fever rose to 103 by 10pm, with headache and body aches (mainly legs). I had very mild nausea & loss of appetite. Over the course of the night, I tried to stay hydrated with water and apple juice. By about 11pm, I took 200mg of Advil. I took another 200mg Advil several hours later. Throughout the next day, Sunday, my fever subsided gradually, significant fatigue persisted as did loss of appetite. By Monday, I was left feeling mostly weak and worn out, but on the road to recovery. By Tuesday morning (now), I feel that the I will be recovered by tomorrow.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,none,none,"acid reflux, otherwise very healthy",,"seasonal/pollen allergy, allergy to cats","['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1084484,CA,26.0,F,"Received both doses of Pfizer covid vaccine (1st dose on 1/21/2021, 2nd dose on 2/11/21. Then presented to ER on 3/08 with fevers, severe HAs and Back pain. Clean CXR, normal u/a, negative covid test. Evaluated by ID who feels meningitis is most likely diagnosis. unclear if there would be a relationship to the COVID vaccine or not.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/11/2021,03/08/2021,25.0,PVT,"Doxycycline, Lamictal, Ondansetron",none,Bipolar d/o,,Nuts,"['Back pain', 'Headache', 'Inappropriate schedule of product administration', 'Meningitis', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1084489,OK,72.0,F,"Immediate swelling and bruising at injection site, size of golf ball, 09:55 Benadryl administered (50mg/ml) IM to L deltoid, 1010 ice pack placed, no report of itching or swelling at any other site. Swelling is reducing at 1030.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PUB,"No medications, over-the-counter medications, dietary supplements, or herbal remedies are being taken.",No illnesses reported.,None reported.,,NKA,"['Injection site haemorrhage', 'Swelling']",1,JANSSEN,IM 1084494,MA,35.0,F,"My Rheumatologist suggested I report this:: I had no side effects other than a sore arm and some tiredness up until approx 6 hours after the injection. At approx 8:30 PM, I was lying in bed and both of my legs from the hips down started to shake violently. It did not feel like the chills as I was not cold and the rest of my body was unaffected. The shakes felt completely involuntary as if my brain was short circuiting. My legs shook so violently that my hip joints began to really hurt. Shaking lasted less than 30 minutes total. I am not sure what stopped the shaking, but I had tried to put my body weight over my legs (body folded in half) to try to stop the shaking and took 1 regular strength tylenol. After the shaking ended, up until I went to sleep (maybe 3-4 hours later) I felt some numbness and tingling in my finger tips and feet. The next day, I felt fine but emailed my Rheumatologist to report the shaking and she directed me to report it here.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,PVT,"Humira, Methotrexate (although I didn't take this for 2 weeks prior to vaccine)",Rheumatoid Arthritis,see above,,"Ceclor, amoxicillin, vancomycin, lactose intolerance & very minor nightshade allergy","['Arthralgia', 'Fatigue', 'Hypoaesthesia', 'Limb discomfort', 'Paraesthesia', 'Tremor']",1,JANSSEN,SYR 1084499,FL,36.0,F,"2/22: RLE started to swell, attempted to elevate overnight but no improvement 2/23: 2+ pitting edema in RLE warm to touch 2/24: 2+ pitting edema in RLE warm to touch, painful and SOB 2/24: went to er: dopper on Right leg and CT with contrast of chest 2/24: admitted to hospital for bilateral PE and DVT in RLE",Not Reported,,Yes,Yes,2.0,Not Reported,Y,01/19/2021,02/22/2021,34.0,PVT,plaquenil and neurotin,none,"sjogrens, osteoarthritis, spinal stenosis, MGUS",,escargot and clindamycin,"['Antiphospholipid antibodies positive', 'Antiphospholipid syndrome', 'Computerised tomogram thorax', 'Deep vein thrombosis', 'Dyspnoea', 'Full blood count', 'International normalised ratio', 'Metabolic function test', 'Oedema', 'Pain in extremity', 'Peripheral swelling', 'Prothrombin time', 'Pulmonary embolism', 'Scan with contrast', 'Skin warm', 'Ultrasound Doppler abnormal']",2,MODERNA,IM 1084507,MA,68.0,M,"Fever chills (shivering) started at 11:30 p.m. on May 8, 2021 Temperature was only 99.5 degrees By 1:00 a.m., March 9, fever was 101.5 degrees By 2:30 a.m. May 9, 2021 fever was 102.5 degrees By 4:00 a.m., March 9, 2021fever had reduced to 101.5 degrees By 9:00 a.m., March 9, 2021 fever had reduced to 99.6 degrees",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PVT,"12.5 mg metoprolol SUCC ER 15 mg lisinopril 10 mg Pravastatin 81 mg baby aspirin Timolol eyedrop, one eye/once a day",None,Managed coronary arterial disease,,None,"['Chills', 'Pyrexia']",1,JANSSEN,IM 1084511,SC,83.0,F,"Per MD/PA report: Received 2nd vaccine on 3/5/21. That evening, began to have diffuse myalgias, became too weak to get up from being seated and could not walk. Was admitted to the hospital for rhabdomyolysis. Hydrated.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,03/05/2021,03/06/2021,1.0,OTH,"ASA 81mg, enalapril, HCTZ, metformin, metoprolol,simvastatin",,"DM, dyslipidemia, HTN",,PCN,"['Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Asthenia', 'Blood creatine phosphokinase increased', 'Gait disturbance', 'Mobility decreased', 'Myalgia', 'Myoglobin urine present', 'Rhabdomyolysis', 'Ultrasound abdomen']",UNK,MODERNA,IM 1084516,VA,81.0,M,"4 days after second short arm of shot ballooned such that no features can be distinguished. Visited Doctor twice but they had not seen anything like this. They ordered scan on left arm for possible blood clots; negative. Prescribed Benadryl every 8 hours, taken for thee days but no relief from sever swelling. It is now 7 days since the arm first swelled up.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/27/2021,03/04/2021,5.0,PUB,many,,heart disease,,Sulphur,"['Blood test normal', 'Peripheral swelling', 'Scan normal']",UNK,PFIZER\BIONTECH, 1084520,NY,40.0,F,Patient complained of dizziness within 5-10 minutes following vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PUB,Unknown,Unknown,gestational diabetes,,hay fever and whole milk,"['Dizziness', 'Immediate post-injection reaction']",1,JANSSEN,IM 1084524,OH,28.0,M,"Cold chills, shivering, muscle & body soreness, chest congestion, coughing, migraine, sweating, fever, exhaustion.. Treatment: water and pedialyte. Time course: several hours into the next morning",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PUB,,None,Cardiomyopathy.,,None,"['Chills', 'Cough', 'Fatigue', 'Feeling cold', 'Hyperhidrosis', 'Lower respiratory tract congestion', 'Migraine', 'Myalgia', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1084536,OH,19.0,F,Vomiting and Nausea 20 minutes after administration of vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,PUB,,,Covid+ in November Fibromyalgia (2019 diagnosis) POTS (2017 diagnosis),,,"['Nausea', 'Vomiting']",1,JANSSEN,IM 1084540,TX,58.0,F,"Patient complaint of itching and burning sensation on face/cheek area, sporadic itching bilateral upper extremities. Event occurred 15 minutes after J & J Vaccine administration. Symptoms Resolved 15 after the event. Cleared by NP.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,"Losartan, Flonase, Allegra Lovastatin, Estrogen",None,"Hypertension, Cholesterol",,"Penicillin, Sulfa drugs","['Burning sensation', 'Pruritus']",1,JANSSEN,IM 1084541,OH,74.0,F,"Janssen COVID-19 Vaccine EUA 19 hours after injection chills, headache, heaviness on chest and dizzy did not feel better until 10 hours later. symptoms gone but still very tired.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,UNK,none,asthma,"Diabetic, high blood pressure, asthma high platelet count (550)",,"Lisinopril, Diovan, Ibuprofen, Cozaar, Daypro, Tramadol, Byetta, Amoxicillin/Clavulanate, Vancominxcin, Invanz, Cephalexin, Bactrim DS, most flowers, and perfumes","['Chest discomfort', 'Chills', 'Dizziness', 'Fatigue', 'Headache']",1,JANSSEN,SYR 1084551,MD,85.0,M,"Per the EUA, cases of COVID-19 vaccination that result in hospitalization or death are to be reported. This patient received Moderna on 3/5. Patient is admitted for upper GI bleed on 3/7. He started experiencing GI bleed prior to receiving first Moderna dose. ?",Not Reported,,Not Reported,Yes,2.0,Not Reported,,03/05/2021,03/07/2021,2.0,PVT,,,,,,['Upper gastrointestinal haemorrhage'],1,MODERNA,IM 1084559,IN,64.0,M,"Around 11 AM on 3/6/21 I began to feel very tired and lethargic. As I had driven back that morning, I returned home and laid down for a nap. Later in the evening, I was still very tired and lethargic. I had no pain, swelling, or redness around my vaccination site. By Sunday morning, 3/7/21 I was feeling fine and have not experienced any symptoms since.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/06/2021,1.0,OTH,Levothyroxine,,,,,"['Fatigue', 'Lethargy']",1,JANSSEN,IM 1084566,NC,44.0,F,Light rash on torso,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,PUB,Norlyda .35mg,,,,"Alpha- gal, latex-skin reaction",['Rash'],1,JANSSEN,SYR 1084573,IN,59.0,F,Light headed first then fever then massive headache and extreme tiredness - lasted for 16 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,"Garden of Life 50 and older multivitamin, probiotic tablet, cortisol tablet, vitamin D, magnesium powder",none,none,,none known,"['Dizziness', 'Fatigue', 'Headache']",UNK,JANSSEN, 1084575,IN,58.0,F,"redness, swelling, knot and pain in arm following injection, pt perceives it to be worsening",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,PUB,"benacar, clonidine",rash- was biopsied - determined to be sequelae of long-covid although never tested pos. Did work as a covid tester,"HTN (controlled) , primary lymphedma,",,"ceclor, anaphylaxis zpack - blisters","['Erythema', 'Nodule', 'Pain in extremity', 'Swelling']",UNK,JANSSEN, 1084579,MD,55.0,M,"pt stated that after he got the vax on 3/8/2021 his pulse went to 170 and BP went to 170/100. He developed tremors, rash, and chest tightness. Vax clinic did an EKG w/ abnormal results. Pt was transported to the Medical Center ER. PT had Chest XRAY, 3 EKGs, and lab work. Pt was released after 5 hours. His DX was vaccine and biological substances causing adverse affects. Pt was told to FU w/ PCP.",Not Reported,,Yes,Not Reported,,Not Reported,U,03/08/2021,03/08/2021,0.0,MIL,"losartan- HCTZ, amlodipine, simvastatin, vitamin D, hydrocodone, bacsolen ,multivitamin, Vitamin C, B12",no,"HBP, cholesterol, chronic lymphocytic leukemia",,Lipitor,"['Blood test', 'Chest X-ray', 'Chest discomfort', 'Electrocardiogram abnormal', 'Laboratory test', 'Rash', 'Tremor']",1,MODERNA,IM 1084581,IN,31.0,F,"Extreme back ache, slight headache, body chills all over",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,UNK,Yaz,None,None,,Ceclor,"['Back pain', 'Chills', 'Headache']",1,JANSSEN,SYR 1084582,KS,87.0,F,"She developed mild swelling of her lips just after midnight on 3/3/21, which she discovered after waking up to use the restroom. She then went back to sleep. She awoke the next morning (3/3/21) to find her lips, tongue, and back of her throat were swollen so much that she couldn't talk. She came to the ED where she received 125mg Solu-Medrol , Pepcid 20mg, and Benadryl 25mg. The swelling initially improved then worsened again and she was admitted to the hospital for overnight observation. Swelling improved and she was discharged on 3/4/21.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/01/2021,03/03/2021,2.0,UNK,Amlodipine-Benazepril (started 06/2017) ASA - she has not had any reactions after taking aspirin or NSAIDs Atorvastatin Ezetimibe Folic acid Metoprolol Omeprazole Miralax Travoprost ophth drops Flonase,none,"hypertension, coronary artery disease, chronic kidney disease, Claudication 4/13/2012, Coronary stent 2007, Diverticulitis, Diverticulosis, Dyslipidemia, GERD (gastroesophageal reflux disease), History of transient ischemic attack (TIA) 9/7/2011, Hyperlipemia , PVD (peripheral vascular disease)",,,"['Alanine aminotransferase normal', 'Anion gap', 'Aphasia', 'Aspartate aminotransferase normal', 'Basophil count normal', 'Basophil percentage', 'Blood albumin decreased', 'Blood alkaline phosphatase normal', 'Blood bilirubin normal', 'Blood calcium normal', 'Blood chloride increased', 'Blood creatinine normal', 'Blood galactose', 'Blood glucose normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea normal', 'C-reactive protein normal', 'C1 esterase inhibitor test', 'Carbon dioxide normal', 'Complement factor C4', 'Eosinophil count decreased', 'Eosinophil percentage decreased', 'Glomerular filtration rate decreased', 'Haematocrit decreased', 'Haemoglobin decreased', 'Immune complex assay', 'Lip swelling', 'Lymphocyte count normal', 'Lymphocyte percentage decreased', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin decreased', 'Mean cell volume decreased', 'Mean platelet volume normal', 'Monocyte count increased', 'Monocyte percentage', 'Neutrophil count increased', 'Neutrophil percentage increased', 'Pharyngeal swelling', 'Platelet count normal', 'Protein total decreased', 'Red blood cell count decreased', 'Red blood cell sedimentation rate normal', 'Red cell distribution width increased', 'Swollen tongue', 'Tryptase', 'White blood cell count increased']",2,PFIZER\BIONTECH, 1084583,NY,62.0,F,"Chills Fever of 101.8 Nausea Muscle Aches Fatigue Trouble Breathing Dizziness Symptoms gradually subsided over 24 hours. Used a rescue inhaler for the breathing troubles, took extra strength tylenol for the fever. Slept for 18 solid hours from 9pm on March 7th till 3 pm on March 8th - had been napping most of the day before 9pm.Fever and fatigue were the last symptoms to resolve.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PUB,"Flovent, Atorvastatin",,Pulmonary illness,,Shellfish and Scallops,"['Chills', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Myalgia', 'Nausea', 'Pyrexia']",UNK,JANSSEN,SYR 1084586,IL,79.0,F,"Patient begin to experience throat tightening, sensation of need to clear throat frequently, voice hoarseness, trouble swallowing, choking sensation and headache 45 minutes after receiving 2nd moderna vaccine. Patient took Benadryl 50 mg OTC and went to ED. Treated with racemic epinephrine, IV benadyl, IV decadron, IV pepcid. Given script for epipen by ED provider, but has not needed to use.",Not Reported,,Yes,Not Reported,,Not Reported,Y,03/04/2021,03/04/2021,0.0,PVT,"Tylenol, albuterol inhaler, allopurinol 100 mg, tums, carvedilol 3.125 mg, cyanocobalamin 1000 mcg, denosumab 60 mg, digoxin 125 mcg, Benadryl 25, furosemide 40 mg, gabapentin 600 mg, hydrocortisone 1% cream, hydroxychloroquine 200 mg, levo",trigger thumb-left hand,"cardiomyopathy, sick sinus syndrome with tachycardia, cardiac pacemaker, hyperlipidemia, atrial fibrillation, hypertension, type 2 diabetes, hypothyroidism, lipodermatosclerosis, granuloma annular right arm, peripheral neuropathy, asthma, Obstructive Sleep Apnea Syndrome, Osteoporosis, osteoarthritis, hallux valgus, hammertoe, seronegative rheumatoid arthritis, idiopathic chronic goat of left foot, diffuse idiopathic skeletal hyperostosis, renal osteodystrophy, pernicious anemia, chronic kidney disease, obesity, renal cyst, long-term use of anticoagulants, anxiety, monoclonal gammopathy, peripheral artery disease, aortic aneurysm without rupture,",,"Carrot, celebrex, clindamycin, cox-2-inhibitors, fenofibrate, fish oil, keflex, lovaza, macrobid, milk protein, naproxen, tequin, wheat, niaspan","['Choking sensation', 'Dysphagia', 'Dysphonia', 'Full blood count', 'Headache', 'Metabolic function test', 'Throat clearing', 'Throat tightness']",2,MODERNA,IM 1084588,UT,60.0,M,Fever moderate muscle pain moderate weakness confusion,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/01/2021,03/08/2021,7.0,PVT,,,Copd aortic anursym,,,"['Asthenia', 'Confusional state', 'Myalgia', 'Pyrexia']",1,JANSSEN,SYR 1084589,NY,49.0,F,"After about 15H after the vaccine I strayed to feel very tired and started having severe body aches, chills, sweating and my teeth were hurting. By 2pm I had 102.5F /103F which lasted all day. At 1am I was in unbearable body ache and 103F that I took Tylenol and finally got some relief. The following morning I felt better still with 100F and body aches but better.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,"I on birth control pill Li loestrin Fe, however I did not take it the night of the vaccination or the following day.",None,None,,None,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Pain', 'Pyrexia', 'Toothache']",1,JANSSEN, 1084601,IN,52.0,M,Began feeling dizzy and nauseated. Started vomiting at approximately 5:00pm and continued until 6:30 or 7:00pm. I could not open my eyes because of the extreme dizziness. Chills Sweating I was able to sleep for a few hours and woke up at 10:00pm and the symptoms had subsided. I woke up with a headache on Sunday morning. That went away and have not had any symptoms since,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,Eliquis Blood pressure medicine Cholesterol medicine,None,,,None,"['Chills', 'Dizziness', 'Headache', 'Hyperhidrosis', 'Nausea', 'Vomiting']",1,JANSSEN,SYR 1084603,NY,38.0,F,"moderate nausea, chills, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,UNK,YAZ,none,none,,none,"['Chills', 'Nausea', 'Pyrexia']",UNK,JANSSEN,IM 1084604,IN,56.0,F,"High fever, 101.5, chills, upset stomach, headache, body aches, joint aches, fatigue. Onset of symptoms was 7 hours after vaccination, escalated to it's worst by midnight, consistent high fever with all symptoms through 11:00 a.m. next day, then symptoms began to subside and were gone 7 hours later. Sore arm and fatigue lasted through the next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,UNK,"Estradiol, low-dose",None,None,,None,"['Abdominal discomfort', 'Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",UNK,JANSSEN,IM 1084607,MD,65.0,M,"Per the EUA, cases of COVID-19 vaccination that result in hospitalization or death are to be reported. This patient received Pfizer vaccine on 2/26/2021. Patient is admitted for sepsis secondary left diabetic foot ulcer.",Not Reported,,Not Reported,Yes,4.0,Not Reported,,02/26/2021,03/05/2021,7.0,PVT,,,,,,"['Diabetic foot', 'Sepsis']",1,PFIZER\BIONTECH,IM 1084612,OH,65.0,F,"Patient received Janseen COVID vaccine. The first 1/2 of the vaccine was given easily IM to the left deltoid and then the patient complained of severe arm pain, tensed her muscles, and the last 0.25ml was difficult to inject. Then the patient became hypotensive 90/45, dizzy, and felt like she was going to pass out. She was laid in the supine position, given a cool cloth for her forehead and monitored for approx. 45 minutes. Her blood pressure remained 90/60, 96/56 at discharge. Her heart rate ranged from 55-65, regular. Her son came to take her home as we did not feel comfortable with the patient driving. The patient was continuously monitored by the NPs and APCT. She ambulated without difficulty and was discharged home. She was given information for V-safe to report her reaction and advised to follow up in the ER for any SOB, difficulty breathing, difficulty swallowing, syncope, CP, etc.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,"citalopram, blood pressure medication (patient does not remember name)",none,"HTN, anxiety",,NKA,"['Dizziness', 'Hypotension', 'Injection site pain', 'Pain in extremity']",1,JANSSEN,IM 1084619,IN,57.0,M,"Severe chills lasting a couple of hours entire body shakes, headache lasting 24 hours, fatigue lasting 24 hours, full body rash still in progress",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/06/2021,0.0,UNK,,,,,,"['Chills', 'Fatigue', 'Headache', 'Rash', 'Tremor']",UNK,JANSSEN, 1084624,IN,61.0,F,Body chills and Aches for approximately 18 t 24 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,UNK,"Paxil 20mg (not time-released), Multivitamin, Calcium with Vitamin D, Fiber, Glucosamine, Chondroitin and MSM, Tru-Niagen, Zyrtec",none,anxiety,,None,"['Chills', 'Pain']",1,JANSSEN,IM 1084628,CT,27.0,F,"Post vaccination lightheaded, pale. Placed supine, felt better. No local injection site reaction, hives, SOB, tongue swelling, palpatations. Lungs CTAB. Sat up drank water and ate a banana.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PUB,None,None,None,,NKA,"['Dizziness', 'Pallor']",1,JANSSEN,IM 1084650,GA,65.0,M,"Myasthenia Gravis, treatment and outcome pending. Ptosis, vertical diplopia, jaw fatigue Positive acetylcholine receptor binding, receptor modulating and receptor blocking antibodies",Not Reported,,Not Reported,Not Reported,,Yes,N,01/19/2021,01/25/2021,6.0,SEN,"Synthroid, Janumet, atorvastatin, gabapentin, Lantus, Lunesta, Hyzaar, alfuzosin, omeprazole, multivitamin, B12, cranberry, Omega complex, magnesium, zinc, Tylenol, vitamin C, L-arginine, biotin, pro-biotics, D3, GABA, collagen, melatonin.",None,"DM 2, hypothyroid, hypertension, elevated cholesterol, sleep apnea, sleep disorder, prostate cancer (in remission), arthritis, over weight.",,Thimerosal,"['Antiacetylcholine receptor antibody positive', 'Diplopia', 'Eyelid ptosis', 'Jaw disorder', 'Myasthenia gravis']",1,MODERNA,IM 1084657,IN,50.0,F,"Fever 102+, chills, aches, headache, nausea, heart rate 135 at rest. Symptoms began 8 hours after injection and lasted for 48 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PUB,Losartan 50mg Omeprazole 20mg Hydrochlorothiazide 25mg Furosemide 20mg,,"HTN, controlled with medication",,PCN,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia', 'Tachycardia']",1,JANSSEN,IM 1084660,IN,62.0,F,This was a Johnson & Johnson vaccine. No option was given on the website for this. Nausea no vomiting for about 10 hours Fever of about 102 20 hours post shot. She experienced a long bout of a fibrillation along with this fever. She?s experienced an abnormal level of confusion with her Alzheimer?s. This morning about 32 hours post shot her temperature is 95�. At 48 hours there were still redness and swelling at the injection site. However all the other symptoms had abated.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,"Sertraline, metoprolol, misodrine, Memantine",None,"Alzheimer?s, Reynards syndrome, afibrillation.",,Sulfa and penicillin,"['Confusional state', 'Injection site erythema', 'Injection site swelling', 'Nausea', 'Pyrexia']",1,JANSSEN,SYR 1084666,NY,21.0,F,Had fever and headache but the event that occurred at the indicated time was uncontrollable movements - almost as if the chills except much more exaggerated movements and higher paced. This was very scary and lasted for an hour or two,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/07/2021,03/08/2021,1.0,UNK,,,IGA deficiency,,,"['Dyskinesia', 'Headache', 'Pyrexia']",1,JANSSEN,SYR 1084685,ME,68.0,M,We received a phone call stating that the patient passed away overnight.,Yes,03/08/2021,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,PHM,unknown,unknown,unknown,,unknown,['Death'],1,MODERNA,IM 1084695,CO,52.0,M,"nausea set in that night, sleepless night, pain in joints, nausea and pain in joints is continuing the day after.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,OTH,none,none,none,,none,"['Arthralgia', 'Insomnia', 'Nausea']",UNK,JANSSEN,IM 1084698,IN,58.0,M,"Fever - treated with OTC (Motrin, Tylenol) Lethargy - treated with rest Symptoms cleared within 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,"Ambien, Flecainide, Dilitiazem",None,Atrial Fibrillation,,None known,"['Lethargy', 'Pyrexia']",UNK,JANSSEN, 1084704,IN,56.0,F,Headache Full body muscle aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,UNK,Prozac 60 mg daily Lorazepam.5 mg prn 3 times daily Vitamin D3 50 mg (2000 IU) Prilosec 20 mg daily Lipitor 20 mg daily Melatonin 3 mg pro at night for sleep Promethazine 25 mg for nausea related to migraine symptoms Advil prn Tylenol prn,,,,Penicillin Morphine Bentyl Cipro,"['Headache', 'Myalgia']",1,JANSSEN,IM 1084707,NY,69.0,M,Low grade fever and slight cough. Pain at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,PUB,"Losartan Postassium, Otezla, Metformin, Flomax, Symbicort",,COPD,,,"['Cough', 'Injection site pain', 'Pyrexia']",1,JANSSEN,IM 1084709,NY,71.0,M,"atrial fibrillation, hypotension, syncope, possible seizure",Not Reported,,Not Reported,Yes,,Not Reported,N,03/06/2021,03/08/2021,2.0,PVT,"albuterol, tiotropium, apixaban, atorvastatin, bisoprol, budesonide-formoterol, donepezil, finasteride, gabapentin, levetiracetam, monteleukast, omeprazole, paroxetine, tamsulosin, pembrolizumab","lung cancer, renal cell carcinoma, COPD, atrial fibrillation, hypogammaglobulinemia","COPD, seizure disorder, atrial fibrillation",,"penicillin, carboplatin","['Atrial fibrillation', 'Blood test', 'Computerised tomogram abdomen', 'Computerised tomogram head', 'Computerised tomogram neck', 'Computerised tomogram pelvis', 'Computerised tomogram thorax', 'Condition aggravated', 'Electrocardiogram', 'Electroencephalogram', 'Full blood count', 'Hypotension', 'Syncope']",2,MODERNA,IM 1084712,IN,58.0,F,"Significant shaking/trembling, chills yet hot, severs fatigue, muscle aches especially in neck area. No fever. If husband hadn?t been home, I would have gone to the emergency room. Symptoms subsided within 8 hours. Ibuprofen really helped.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,Atorvastatin,None,None,,None,"['Chills', 'Fatigue', 'Feeling hot', 'Musculoskeletal discomfort', 'Myalgia', 'Tremor']",1,JANSSEN,IM 1084718,MD,34.0,F,"Janssen COVID-19 Vaccine EUA. Started feeling very tired two-three hours after the vaccination, got a mild fever approx 9 h after the vaccination and high fever (38.5 C) after 11 h. Strong dehydration feeling, nose numbness, chills, sensible skin feeling and dizziness. Fever and side effects approx 6-8 h and disappeared approx 17h after the vaccination",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,,,,,,"['Chills', 'Dehydration', 'Dizziness', 'Fatigue', 'Hypoaesthesia', 'Pyrexia', 'Sensitive skin']",1,JANSSEN,IM 1084730,NY,25.0,F,Woke next morning with rash and itching on front lower neck and upper chest. Buring sensation to touch. Rash still present w/o change >72 hours. Recommended taking antihistamine and if no result trying topical steroid. Outcome pending,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,PHM,None,None,None,,"Amoxicillin, tree nuts","['Burning sensation', 'Pruritus', 'Rash']",1,JANSSEN,IM 1084731,ME,76.0,F,Hypotension and development of colitis,Not Reported,,Not Reported,Yes,4.0,Not Reported,N,03/05/2021,03/05/2021,0.0,PVT,"Azopt, ibuprofen, lisinopril, and triamterene-hydrochlorothiazide",none,"Benign essential hypertension, degenerative joint disease of hands bilaterally, glaucoma, irregular heart, lyme arthritis, chodromalacia of patella, osteoarthritis of glenohumeral joint, atrophy of vocal cord, bradycardia, migraine without aura, dyspnea on exertion, central hearing loss, and skin lesion",,"Doxycycline hyclate, and keflex","['Colitis', 'Hypotension']",2,MODERNA,IM 1084735,IN,60.0,F,Extreme headach,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,OTH,,,,,"Sulfa, seasonal",['Headache'],1,JANSSEN,SYR 1084737,IN,41.0,F,Chills Severe Aches Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,UNK,Amitriptyline 25 mg Women's multivitamine Over the Counter Calcium Supplement Hair Skin and Nails Supplement,None,IBS,,Penicillin Dairy,"['Chills', 'Fatigue', 'Pain']",UNK,JANSSEN, 1084740,IN,55.0,M,"Fever, joint pain, headache, chills. Treated with Tylenol. Lasted for approx. 19 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,UNK,"multi vitamin, meloxicam",None,None,,"latex, penicillin","['Arthralgia', 'Chills', 'Headache', 'Pyrexia']",1,JANSSEN,IM 1084748,,69.0,F,"Upon administering the vaccine, the patient pulled her arm away as the medication was entering her arm. There was 0.1 mL of the vaccine that did not get injected and was lost. The patient was informed and had no immediate adverse reactions.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/04/2021,03/04/2021,0.0,PHM,,,,,,"['No adverse event', 'Underdose']",1,JANSSEN,IM 1084750,NC,45.0,F,"Got vaccine at 5:36 pm and during waiting time afterward, she reported around 5;53 pm having generalized tingling then followed by generalized pruritis. Denied and did not exhibit signs of urticaria, angioedema, cough, dyspnea, wheezing, CP, abdominal pain, nausea, vomiting, abdominal pain, lightheadedness, weakness, pallor, tachycardia. Discussed giving her diphenhydramine and she agreed stating she had no previous adverse reaction to this treatment. At 5:56 pm, I gave diphenhydramine HCL 50 mg/ml 1 ml IM in her right deltoid muscle. Around the time of the injection (approximately 5:59 pm, pulse was 76, oxygen saturation 97%, BP 138/90, lungs clear, heart RRR. Within 20 minutes (6:22 pm) of diphenhydramine injection, she reported that the tingling had largely subsided (only remaining in lower legs) and her pruritis was improving. Her pulse was 77, oxygen saturation 96%, and BP 126/82 at that time. She also reported she had not developed any new symptoms (see above). By 6:28 pm, she reported no further tingling nor pruritis and feeling well. We released her at that time as we deemed her recovered from the symptoms. We advised her to call 9-1-1 if the symptoms returned especially with one or more of the above symptoms she had twice denied experiencing. 3/9/21 11:47 a.m. Called to check on status. No answer. Left message.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,Unknown,Unknown.,"Chronic pain, pollen and dust allergies. Other not known.",,No known medication or food allergies or allergy to other products. Did report having year round allergies to pollen and dust.,"['Paraesthesia', 'Pruritus']",,JANSSEN,IM 1084757,IN,51.0,F,"Fever, muscle aches, joint aches, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,OTH,Synthroid,No,No,,,"['Arthralgia', 'Headache', 'Myalgia', 'Pyrexia']",UNK,JANSSEN,IM 1084768,IN,50.0,M,Chills and fever,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,Allergic OTC Bentyl 20mg Diclofenac sodium 75mg NIFEdipine 30mg Irbesartan 300mg Omeprazole 40mg Metformin 500mg,None,High blood pressure,,None,"['Chills', 'Pyrexia']",1,JANSSEN,SYR 1084774,SC,30.0,M,"Injection Site soreness, chills and fever about 12 hours after receiving Vaccine, slight headache the following morning .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/09/2021,1.0,WRK,,,,arm soreness,,"['Chills', 'Headache', 'Injection site pain', 'Pyrexia']",1,JANSSEN,IM 1084788,,63.0,F,"When administering the vaccine, the patient pulled her arm away as the medication was being injected. Less than 0.1 mL of the vaccine was lost and not injected into her arm. The patient was informed and did not have an immediate adverse reactions.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/08/2021,0.0,PHM,,,,,,['Incorrect dose administered'],1,JANSSEN,IM 1084789,NY,46.0,F,"FEVER OVER 100, SEVERE HEADACHE, BODY ACHES, CHILLS, RIGORS, SHARP PAINS, CAUSED MY NERVE PAIN FROM THE STROKE TO BE VERY BAD, TINGLING ON MY AFFECTED SIDE, NAUSEA, DIZZINESS, DEHYDRATION, FATIGUE. I WAS GIVEN TYLENOL, IBUPROFEN, ZOFRAN, ATIVAN, AND 2 BAGS OF FLUIDS.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,PUB,"CYMBALTA, LEVOTHYROXINE, HYDRCHLOROTHIAZIDE, MELOXICAM, VITAMIN D, VITAMIN E",NONE,"2018 CVT, VAD WITH CEREBRAL STROKES, HYPERTENSION",,"GOLD, COBALT, NICKLE","['Blood test', 'Chest X-ray normal', 'Chills', 'Condition aggravated', 'Dehydration', 'Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Paraesthesia', 'Pyrexia', 'SARS-CoV-2 test negative', 'Urine analysis normal']",1,JANSSEN, 1084793,MA,60.0,F,"Hypotension in the 70s/40s despite IV fluid replenishment. Per our MD DC/transfer note: PEG displacement, ongoing sepsis, hypoglycemia. Assess for other reason for hypotension including sepsis, cardiogenic shock, acute abdominal processes. patient was transferred to the Hospital ER where she expired",Yes,03/06/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,PVT,"Tylenol 650mg q6h prn, Eliquis 5mg BID, Albuterol MDI q6h prn, Atenolol 75mg daily , Atorvastatin 80mg daily , Questran 4gm daily, Lexapro 25mg daily, ferrous sulfate 300mg daily, fluconazole 400mg daily, Lasix 10mg daily, Lispro in",angioedema thought to be secondary to lisinopril esophageal perforation abdominal ascites,AFIB HTN GERD depression,,Lisinopril Naproxen Gadolinium,"['Acute abdomen', 'Cardiogenic shock', 'Death', 'Fluid replacement', 'Gastrostomy', 'Hypoglycaemia', 'Hypotension', 'Sepsis']",1,MODERNA,IM 1084796,IN,54.0,M,"Chills, body aches, headache, & fatigue. I had COVID-19 in early December and these symptoms are very similar.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,OTH,Sertaline,None,None,,Penicillin,"['Chills', 'Fatigue', 'Headache', 'Pain']",1,JANSSEN,SYR 1084798,FL,64.0,F,"She reports some fatigue, loss of appetite and dizziness, and went to bed early on the night of her 2nd vaccination. On Feb 12th, she reports receiving Botox and Juvaderm facial fillers. She reports she felt fine until Feb 11th or 14th, when reports feeling fatigue which gradually worsened in the following weeks. She reports around this time going to MD Now Urgent Care. Around Feb 13th to the 17th, she developed N/V and loss of appetite, which also gradually worsened in the following weeks. She reports she stopped eating around this time due to the symptoms. She drank alcohol daily until February 18th. Between Feb 18th to 25th, she noticed that a hematoma developed on the site of injection and bruises on other places. She reports onset of productive cough with white sputum and yellow diarrhea which occurred (several times daily). Both of these symptoms also gradually worsened in the following weeks. On Feb 27, she couldn't tolerate oral intake. She was admitted to Hospital on Feb 28",Not Reported,,Not Reported,Yes,9.0,Not Reported,Y,02/04/2021,02/04/2021,0.0,UNK,"Atenolol 25mg, atorvastatin 40 mg, lisinopril 10 mg, isosorbine mononitrate 60 mg, allopurinol 300 mg, Estrace Vag cream 2x week, Zolpidem 5 mg, diazepam 5 mg, Brimonidine drops, Dorzolamide drops, Latanoprost drops","She denies prior symptoms. She was told 2-3 years before that she had mild elevation of liver enzymes. No specific work up done, as per patient,","Hypertension, hyperlipidemia, coronary artery disease, hyperuricemia, insomnia, anxiety, cold sores, daily alcohol consumption x 20 years, glaucoma, rosacea.",,IV contrast -Iodine,"['Alanine aminotransferase increased', 'Alcohol use', 'Anti-actin antibody positive', 'Antinuclear antibody increased', 'Aspartate aminotransferase increased', 'Blood bilirubin increased', 'Blood creatinine increased', 'Contusion', 'Cytomegalovirus test', 'Cytomegalovirus test negative', 'Decreased appetite', 'Diarrhoea', 'Dizziness', 'Epstein-Barr virus test negative', 'Faeces discoloured', 'Fatigue', 'Hepatitis A virus test', 'Hepatitis B test negative', 'Hepatitis C test negative', 'Hepatitis E virus test', 'Herpes simplex test negative', 'Hypophagia', 'Injection site haematoma', 'International normalised ratio increased', 'Nausea', 'Productive cough', 'SARS-CoV-2 test negative', 'Sputum discoloured', 'Vomiting']",2,MODERNA,IM 1084800,TX,54.0,F,Death. EMS called to residence 9 hours later for cardiac arrest. Pt pronounced at Emergency Room. Pt sent to ME office for autopsy.,Yes,03/08/2021,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,OTH,unknown,none reported,liver transplant. Doctor advised pt to get the covid vaccine.,,NKDAnone reported,"['Autopsy', 'Cardiac arrest', 'Death']",1,MODERNA,IM 1084808,IN,37.0,M,"Very dry/sore throat, intermittent lose of voice, low-grade fever, body shivering/chills, pressure/tension headache, hard spot at injection site, joint pain/stiffness, ringing of ears; all for around 40 hours and slowly clearing up. *Tylenol, ibuprofen, cold/flu meds had minimal effect.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,"Chlorthalidone, Potassium, Cetirizine",,Kidney stones,,"Amoxicillin, Coconut, Alcohol (Liquor), Seasonal allergies","['Aphonia', 'Arthralgia', 'Chills', 'Dry throat', 'Injection site induration', 'Injection site pain', 'Joint stiffness', 'Oropharyngeal pain', 'Pyrexia', 'Tension headache', 'Tinnitus']",1,JANSSEN,IM 1084812,CO,32.0,F,"Janssen COVID-19 Vaccine EUA. Mid Saturday night I woke up to chills and was shaking so bad I couldn't fall back asleep even after adding another layer of clothes and blanket. Sunday morning I was still very cold and tired from not sleeping. I developed body aches but they were everywhere not just my arm. I was very fatigued and didn't have an appetite. The worst part was getting a migraine with extreme light sensitivity. I couldn't stand to be around any windows without blinds. I spent the day in my bedroom sleeping with the curtains closed and an eye mask on. By that night, the migraine had subsided but I was adding hot flashes to the problem list. Had a pretty restless night again on Sunday. Woke up Monday to the light sensitivity back but not as severe. I took the day off work because I couldn't handle looking at a computer screen all day. By about 1pm I was feeling mostly back to normal. My arm is still sore near the injection site and I'm a bit fatigued at times but those are the only things remaining.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PVT,Daily prenatal vitamin,Diagnosed with Pericarditis on March 3rd. Have been having chest pain since late January (think I had Covid but had 3 negative tests).,None,,"Iodine - get a rash where applied to skin Naproxen Sodium - would get upset stomach, but think it was only related to one medication. Haven't had problems since stopping it.","['Chills', 'Decreased appetite', 'Fatigue', 'Feeling cold', 'Hot flush', 'Injection site pain', 'Migraine', 'Pain', 'Photosensitivity reaction', 'Restlessness', 'Tremor']",1,JANSSEN,IM 1084813,IN,55.0,F,"Freezing Cold, achy starting two hours after getting shot the following day continued with extreme feeling of cold and achy tired and was also nauseous. Began to feel better starting at 36 hours after shot all nausea and freezing seemed to clear up around 48 hours. Arm hurt and still hurts to touch 4 days later",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,Magnesium GABA Omega 3 Phenibut Vitamin D Turmeric,None,None,Flu vaccines - sore arm and flu like symptoms,Penicillin Keflex Sulfa Eggs Bee Stings,"['Fatigue', 'Feeling cold', 'Myalgia', 'Nausea', 'Pain in extremity']",UNK,JANSSEN,SYR 1084817,KY,37.0,F,"Fever, chills, fatigue, heart palpitations, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,PHM,"Lithium, levothyroxine, lamotrigine, Vraylar",,Bipolar disorder,,Cipro,"['Chills', 'Fatigue', 'Headache', 'Palpitations', 'Pyrexia']",1,JANSSEN,SYR 1084823,IN,56.0,F,"The next morning after you got to church all of sudden had major flu-like symptoms. She went home immediately and noticed fever of 100.4, chills, body aches, nausea, headache. She took Tylenol for this, which eased up some of the symptoms and reduced her fever. She still had the chills without the fever, but just slept. Yesterday around 5:00 PM, 3/8/21 the symptoms went away.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,"Seroquel, Hydrochlorothiazide, Wellbutrin, other BP medicine, Meloxicam.",None.,"High blood pressure, asthma, COPD, CAD.",,"Gabapentin, Lisinopril, bee venom.","['Chills', 'Headache', 'Influenza like illness', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1084827,IN,57.0,M,Fatigue since the evening of the test,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,OTH,"Lamotrigine, Simvastatin , Daily Vitamin","I experienced Covid like symptoms from about 2/22 to about 3/5. Mainly fatigue, but some aches. Tested negative for Covid 2 times in that period.","Diabetes, partial seizures",,Morphine,['Fatigue'],1,JANSSEN, 1084830,IN,51.0,M,"Chills, Fever (101.0), Achy, Sore muscles, Stiffness, injection site pain, mental fuzziness, Headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,,None,None,,,"['Chills', 'Feeling abnormal', 'Headache', 'Injection site pain', 'Muscle discomfort', 'Musculoskeletal stiffness', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1084832,IN,53.0,M,"Chills, sweats, fever, sleeplessness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,,,,,,"['Chills', 'Hyperhidrosis', 'Insomnia', 'Pyrexia']",1,JANSSEN,SYR 1084838,IN,56.0,F,"Fatigue, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PVT,"Singular, Zyrtec, flonas, snythroid, omeprazole, vitamin E, Vitamin D3,",None,"Fibromyalgia, fatty liver, positive ANA, Asthma, seasonal allergies, arthritis",,"Dulidid, ultram, humia","['Chills', 'Fatigue']",1,JANSSEN,SYR 1084847,IN,50.0,F,"Fever, headaches, chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,UNK,Blood pressure,,,,,"['Chills', 'Headache', 'Pyrexia']",1,JANSSEN,SYR 1084852,IN,63.0,M,Headaches starting in late afternoon increasing in intensity towards evening. Feeling feverish by 8:00 PM. Took Tylenol and went to sleep. Woke up in the middle of the night with a fever of 100. Took two more Tylenol and slept until 9:00 AM. Felt fine and temperature was back to normal.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,"Fluoxetine, Allopurinol, Alfuzosin, Advair Diskus, Alive Multi-Vitamin, Vitamin D3",None,"Anxiety, Enlarged Prostate, High Uric Acid level, Mild COPD,",,None,"['Headache', 'Pyrexia']",UNK,JANSSEN,IM 1084949,PR,95.0,F,Patient dies suddenly 4 days after the vaccine,Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/24/2021,4.0,UNK,"Seroquel, zolofot, lantus, toprol, lozartan, furocemide and prevacid","Hypertension, Diabetes and mild cognitive impairment controlled",Hypertension and Diabetes,,None,['Sudden death'],UNK,PFIZER\BIONTECH,IM 1084952,IN,53.0,F,Severe chills - began at 8pm ET 3/7/21 and lasted until approximately 6am 3/8/21 Headache - began at 8pm ET 3/7/21 and lasted until 6pm 3/8/21 Nausea - began at 8pm ET 3/7/21 and lasted until approximately 6am 3/8/21,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,Duloxetine HCL DR 60mg buPROPion HCL XL 300mg Levothyroxine 50 MCG Vitamin D3 5000 IU Oxybutynin CL ER 15mg Pantoprazole SOD DR 40mg Rosuvastatin Calcium 10mg Xanax 1mg Amitriptyline HCL 50mg Esratest,none,Anemia,Shingles VARICELLA-ZOSTER GLYCOE VACC-AS01B ADJ(PF) SHINGRIX; received on 1/25/21. Adverse reaction of stiff neck started 1/26/2,demerol - facial itching soy - diarrhea,"['Chills', 'Headache', 'Nausea']",1,JANSSEN,IM 1084954,IN,51.0,M,Severe chills. Moderate body aches. Moderate headache. Fever (peaking at 101.3). Symptoms lasted approximately 30 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,Tasigna 200mg x2 Losartan 25mg Atorvastatin 10mg Levothyroxine 50mcg Wellbutrin 150mg,,Chronic Myeloid Leukemia,,,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1084957,IN,58.0,F,Chills (inability to get warm) began at 9am for approx 3 hours. Increased room temp and more blankets. Finally warmed up enough to fall asleep for 2-3 hours. Awakened at 3pm flushed and hot. Began tracking temperature started at 100 increased to 101.8. Forced water by mouth during the episode. Took a shower when temperature reached 101.8 and took OTC Tylenol extra strength. Slowly returned to normal.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,"Metoprolol, eloquis, flecainide, Bariatric Multivitamin, calcium citrate, tylenol",Lower back injury/receiving chiropractic care. AFib/ cardioversion 3/1/21,Obesity,,none known,"['Body temperature increased', 'Chills', 'Feeling cold', 'Feeling hot', 'Flushing']",UNK,JANSSEN,SYR 1084960,IN,62.0,F,"Fever, chills and body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,Synthroid and propanolol,,,,Sulfa drugs,"['Chills', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1084965,CA,84.0,M,"Injection in left arm at 4:15 pm. on Friday 3/5/2021. At 9pm, 3/5/2021 he complained of chest pain and was taken by ambulance to Medical Center Emergency Room. He was diagnosed with gallstones and discharged at approx 4:00 am on 3/6/2021. He found non responsive at home shortly thereafter.",Yes,03/06/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/05/2021,0.0,OTH,Tlenol; Xarelto; Flomax; Ditropan; Cyclobenzaprine,None,"Obesity, blood clotting, possible pre-diabetes per the patient",,none,"['Chest X-ray', 'Chest pain', 'Cholelithiasis', 'Computerised tomogram abdomen', 'Electrocardiogram', 'Full blood count', 'Scan with contrast', 'Ultrasound biliary tract', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH,SYR 1084968,IN,50.0,F,"Chills, headache, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/08/2021,1.0,OTH,Na,Na,Na,,Na,"['Chills', 'Fatigue', 'Headache']",1,JANSSEN,SYR 1084972,IN,55.0,M,Chills fever joint aches lasting about 8 hrs,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,Venlafaxine,None,None,,None,"['Arthralgia', 'Chills', 'Pyrexia']",1,JANSSEN,IM 1084976,CT,39.0,F,"Body aches, chills, fatigue, ear blockage; tinnitus; migraine/headache no medical treatment was sought; took Advil for the migraine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PVT,,,,,,"['Chills', 'Ear congestion', 'Fatigue', 'Headache', 'Migraine', 'Pain', 'Tinnitus']",1,JANSSEN,SYR 1084979,IN,55.0,M,"Chills, sweating, back ache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,None,None,None,Illness from 2nd Shingles vaccine,None,"['Back pain', 'Chills', 'Hyperhidrosis']",1,JANSSEN,SYR 1084981,IN,52.0,M,"Headache, muscle aches, stuffy nose, chills, fatigue. All very mild. All gone by the following morning.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,Plavix 75 mg Rosuvastatin 20 mg Niacin 1000 mg Losartan 25 mg CoQ10 300 mg Metaformin 1000 mg Multivitamin Aspirin 81,,Coronary Artery Disease,"headache, muscle aches, chills, fatigue",,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nasal congestion']",UNK,JANSSEN,SYR 1084983,IN,29.0,F,"Cold chills, intense arm pain, heavy sweats, nausea, joint/bone pain, headaches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,,,,,,"['Arthralgia', 'Bone pain', 'Chills', 'Fatigue', 'Feeling cold', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pain in extremity']",1,JANSSEN,SYR 1084985,IN,55.0,M,Nausea body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,OTH,Loratidine Lisinopril Flutocason Artorvardstatin Ibuprofein Aspirin Esomeprazol,,Stage 1 Hyper Tension,,Penicillin,"['Nausea', 'Pain']",1,JANSSEN,SYR 1084990,,60.0,F,"I had the most peculiar taste in my mouth. It wasn't entirely a metal taste, but it was strong enough it overwhelmed the taste of everything else for about 6 hours. I could still taste other things, but the primary taste and the one that remained in my mouth was this odd, almost metal taste. The next day (after the taste was gone)- it would have been almost 24 hours from the time of the injection - I was hit with a bad headache and body aches like I haven't had in many years. The body ache was gone the next morning, and the headache lingered another day past that. Today, Tuesday March 9, is the first day I feel like myself again.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,Claritin (over-the-counter),None,,,Compazine,"['Dysgeusia', 'Headache', 'Pain', 'Taste disorder']",1,JANSSEN,SYR 1084991,IN,51.0,F,"Headache, muscle aches, fever over 100. Lasted one day. No treatment, only rest. Day two symptoms were gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,"Fluoxetine HCL 40 mg, Omeprazole DR 20 mg, Fexofenadine HCL 180 mg, Meloxicam 15 mg, Montelukast Sod 10 mg, B-12 2500 mcg",No,"Asthma, seasonal allergies, depression, reflux",,No,"['Headache', 'Myalgia', 'Pyrexia']",,JANSSEN,UN 1084995,,,U,Your form will not let me pass,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,"Flu, allergic reaction, 1989, 1996, unknown manufacturer, etc.",,['Unevaluable event'],UNK,JANSSEN, 1084996,IN,54.0,M,"36 hours of body aches, fever, headache. 48 hours of fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,Benazepril and daily aspirin,None,High blood pressure,,None,"['Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1084998,CA,74.0,F,Severe skin reaction at site-almost like cellulitis-reddened and extremely swollen,Not Reported,,Not Reported,Yes,,Not Reported,,03/02/2021,03/05/2021,3.0,OTH,,,,,,"['Injection site erythema', 'Injection site reaction', 'Injection site swelling', 'Skin reaction']",2,MODERNA,IM 1085001,IN,50.0,F,"Fatigue, headache, muscle aches, fever of 100.7",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,"Amlodipine, Wellbutrin, Claritin, daily multi-vitamin",none,"high blood pressure, obesity",,none,"['Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,JANSSEN,IM 1085014,IN,50.0,F,"body aches starting 15 hours post-injection, fatigue starting 17 hours post-injection, fever starting 18 hours post-injection. Fever lasted 6 hours, fatigue and body aches continued into next day lasting 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,UNK,multivitamin,none,none,,none,"['Fatigue', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1085019,WA,65.0,F,"Had vaccine on 3/3/2021 at approximately 1 PM. She was found on her couch deceased on 3/8/2021. Possible death on 3/5/2021. She called her sister and told sister that back hurt worse than usual and she would lay on the couch and rest. This is where she was found. Unknown if from vaccine, but due to vaccination on Wednesday proceeding her death, report is being filed.",Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,U,03/03/2020,03/05/2021,367.0,PVT,"Multi vitamin, promethazine 25 mg, omeprazole 20 mg, cyclobenzaprine, 10 mg, oxycodone/APAP 5/325mg, gabapentin 800 mg, simvastatin 20 mg tab, metformin 1000 mg tab, nortriptyline 50 mg cap, zolpidem 10 mg tab, Ketorolac 60 mg injection 2 t","Chronic pain, HTN, DM, Cervicalgia, nausea, insomnia","Tobacco abuse, HTN, Diabetes mellitus, DJD, Cervicalgia, osteoarthritis, chronic pain, opioid use, diabetic polyneuropathy, carpal tunnel syndrome bilaterally, atopic dermatitis, bursitis , history of DVT, LE edema, chronic nausea, hyperlipidemia, insomnia,",,"Benzodiazepines, celecoxib, codeine, diphenhydramine HCL, inositol Niacinate, Metaxalone, Niacinamide, oxycodone HCL, ASA, horse/equine containing products,, erythromycin base products, shellfish derived, bee venom","['Back pain', 'Death']",2,MODERNA,IM 1085023,IN,53.0,F,"Started with chills about 12 hours after the shot, headaches, nausea, light-headedness (nearly passed out), dry-heaving, fatigue (slept on and off for 24 hours) Symptoms lasted about 36 hours and then I felt fine again.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,Zoloft,,,,,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Nausea']",1,JANSSEN,SYR 1085025,CT,58.0,M,"Muscle cramps, nausea , headache, chills, fever 100.4",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,UNK,,,,,,"['Chills', 'Headache', 'Muscle spasms', 'Nausea', 'Oral herpes']",UNK,JANSSEN,IM 1085027,IN,52.0,M,Started developing a sore throat two days after the vaccination.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/09/2021,2.0,OTH,Levothyroxine 0.112Mg (112Mcg) Tablet Bupropion Xl 300Mg Tablets Venlafaxine Er 75Mg Capsules Indomethacin 50Mg Capsules Topiramate 25Mg Tablets Nortriptyline 25Mg Capsules Viagra 100mg Tablets Metformin Er 500Mg 24Hr Tabs Atorvastatin 40M,,"Obesity, depression, NA fatty liver disease, pre diabetic.",,,['Oropharyngeal pain'],1,JANSSEN,SYR 1085032,AR,58.0,F,"Patient received dose #2 of her Moderna COVID vaccine on 2/25/21. Patient called in to work the next day 2/26/21 because she was not feeling well. Patient did not show up to work on Monday 3/1/21 and her supervisor, called the PD to check in on her and she was found deceased in her home.",Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,N,02/25/2021,02/26/2021,1.0,PVT,unknown,unknown,unknown,,NKA,"['Death', 'Impaired work ability', 'Malaise']",2,MODERNA,IM 1085038,IN,50.0,M,"Chills, shivers, headache, body aches and soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,,,,,,"['Chills', 'Headache', 'Pain']",1,JANSSEN,SYR 1085046,IN,51.0,M,"Fever, fatigue, congestion, sore arm, sore muscles. The fever started the morning after the shot, and lasted all day. On the second day I woke up with the fever continuing, though the symptoms weren't as strong, and by 3pm they were gone. But that evening when getting ready for bed I experienced extreme shaking and chills, and sweated all throughout the night. On day three I continue to be fatigued, but no fever.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/07/2021,1.0,OTH,"Lexapro, Atorvastatin",none,migraine headaches,,Wellbutrin,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Pyrexia', 'Respiratory tract congestion', 'Tremor']",1,JANSSEN,IM 1085051,CO,36.0,F,"Passed out approximately an hour after vaccine administration after waiting in the facility for over 30 mins, while driving. Stopped breathing, broke bones in 8 different places in my face requiring surgery. Still recovering.",Not Reported,,Not Reported,Yes,9.0,Not Reported,N,01/27/2021,01/27/2021,0.0,PHM,"Keppra 1250 mgs SID, Levothyroxine 100 mcg SID, nortriptyline 25 mgs SID",N/a,"Seizures, hashimotos thyroiditis",,,"['Computerised tomogram', 'Facial operation', 'Full blood count', 'Loss of consciousness', 'Multiple fractures', 'Respiratory arrest', 'X-ray']",1,MODERNA,UN 1085052,IN,59.0,M,"Severe chills at 11:30 pm night of vaccine. Lasted 1 1/2 hours. Woke up next day with mild fever and slight headache. Both went away shortly thereafter. Felt lethargic all day, little appetite. Felt 100% better next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,UNK,None,None,None,,,"['Chills', 'Decreased appetite', 'Headache', 'Lethargy', 'Pyrexia']",UNK,JANSSEN,IM 1085062,IN,52.0,F,"Fever, aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,PUB,Travoprost,,Ocular hypertension,,"NSAIDs, tramadol, macrobid","['Pain', 'Pyrexia']",1,JANSSEN,SYR 1085063,IN,57.0,F,"I experienced body aches, headache, anxiety in my chest (once), tiredness. One other thing that happened that may not be related is that my secondary implant eye socket became very sore and swelled up. It could of been for another reason but the timing was uncanny. I am feeling fine now and none of my reactions were that troubling. I have experienced about 3 times a sudden feeling in my body that made me think I wonder if that was the vaccine but I am feeling great now and all is good. Thank you so very much for all the research and production of these life saving vaccines.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,Took on the evening of 3/6/2021 Lisinopril 10-12.5 Atorvastatin 10 mg,,High Blood Pressure High Cholesterol,,Latex Lortab (Vicatan) Ampicilian (In 1965) Bupropion SR (2010 -2011) Hydrocodone - APAP (Norco),"['Anxiety', 'Eye pain', 'Eye swelling', 'Fatigue', 'Feeling abnormal', 'Headache', 'Pain']",UNK,JANSSEN, 1085077,TX,43.0,F,"Day of vaccine - Throat felt like someone was pushing on either side, numbness in sinuses (nose, cheeks, upper jaw, tongue), bad headache (almost immediately) Next day - congestion, bad headache, body aches, chills, coughing, more throat symptoms, numbness in sinuses",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,OTH,"Zyrtec, cinnamon, cranberry, antacid",None,None,,"Penicillin, sulfa","['Chills', 'Cough', 'Headache', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Immediate post-injection reaction', 'Intranasal hypoaesthesia', 'Oropharyngeal discomfort', 'Pain', 'Respiratory tract congestion', 'Throat tightness']",1,JANSSEN,IM 1085081,IN,54.0,F,Woke up at 1:00am with chills and uncontrollable shaking. Took Tylenol PM and fell back to sleep. Woke up at 5:30am with headache and full body muscle aches. 1:00 pm took Advil and felt much better an hour afterwards.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,"Advil, multi vitamin",None,None,,Sulfa,"['Chills', 'Headache', 'Myalgia', 'Tremor']",UNK,JANSSEN,SYR 1085088,IL,88.0,M,"Bells' Palsy, started on March 4th, right sided facial droop, and visual changes. Admitted to Hospital, worked up for CVA, and started on steroids and valacyclovir",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/15/2021,03/04/2021,17.0,OTH,"allopurinol, atorvastatin, chlorthalidone, citalopram, Lotrisone cream, glimepiride, metformin, nifedipine",No,"Diabetes, Hypertension, CKD, Gout, Depression, GERD",,"Ampicillin, Demerol, Hydroxyzine, Mepridine, Pencillin, Sulfa","[""Bell's palsy"", 'Cerebrovascular accident', 'Facial paralysis', 'Full blood count', 'Magnetic resonance imaging', 'Metabolic function test', 'Visual impairment']",UNK,MODERNA,IM 1085095,CO,58.0,M,"Headache, slight fever, body aches, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,Levothyroxine 125 mcg,None,None,"Similar symptoms Shrillax shot number 1, Age 58, previously reported",None,"['Headache', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1085098,KY,48.0,F,"PATIENT RECEIVED VACCINATION AROUND 9:45 AM TODAY, 3-9-21. PATIENT THEN CALLED PHARMACY AT 1:09 TO LET US KNOW THAT AT AROUND 11:00 SHE STARTED GETTING A HEADACHE AND BEGAN VOMITING. PATIENT HAS SINCE VOMITED 4 TIMES AND WAS INSTRUCTED TO SEE HER PRIMARY CARE PROVIDER.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,PHM,"CLONIDINE 0.1 MG, ZOLOFT 100 MG, CHANTIX 0.5 MG, SPIRIVA HANDIHALER, SUCRALFATE 1 GM, BUPROPION XL 150 MG, MONTELUKAST 10 MG, CETIRIZINE 10 MG, ALBUTEROL INHALER, VITAMIN D 1,000 IU, IPRAT-ALBUTEROL 0.5-3 MG, FLUOXETINE 40 MG, ASPIRIN 81 MG",PNEUMONIA AND FLUID RETENTION (2.5 WEEKS AGO),"COPD, EMPHYSEMA, DEPRESSION",,LEVOFLOXACIN,"['Headache', 'Vomiting']",1,JANSSEN,IM 1085101,IN,55.0,M,Spiked a fever of 101+ still feeling a but drained. Fever is gone,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/07/2021,0.0,OTH,,,,,,"['Fatigue', 'Pyrexia']",UNK,JANSSEN, 1085114,IN,51.0,F,I woke up with swollen lymphnodes the next day and the area is still swollen and tender to the touch.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,PVT,Birth control Vitamins C D E Biotin Multi vitamin Fish oil supplement Advair,None,Asthma,,Aspirin,"['Lymphadenopathy', 'Tenderness']",1,JANSSEN,SYR 1085115,OH,58.0,M,felt like his eyes were burning from the inside out and lasted 3 days. Patient did not seek treatment,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PHM,"Spiriva, Aspirin, Venlafaxine, Esomeprazole, Atorvastatin , Potassium, Amlodipine, Atenolol, Alprazolam",histoplasmosis,"histoplasmosis, bad heart and lungs",,"Levofloxacin, lisinopril, ace inhibitors, Quinolones",['Eye irritation'],1,JANSSEN,IM 1085133,MI,65.0,F,"Nausea, headaches, tired. Chills",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/05/2021,03/06/2021,1.0,PUB,Multi vitamin. Fish oil. Wellbutrin 100mg,,,,Levoguin,"['Chills', 'Fatigue', 'Headache', 'Nausea']",UNK,JANSSEN,SYR 1085166,NY,73.0,F,"Anaphylactic reaction-flushing, lump throat, cough onset within 10 minutes. InER 2hrs home on medication solumedrol, benadryl,pepcid, IV fluids",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PVT,"Prednsone, Diovan,Lipitor, MgCaZn, vit D3, baby ASA, cinnimon, benadryl, cq10",,"asthma, lupus, hypertension, arthritis",,"sulfities, sulfa, penicillin, vasotec, tree nuts, injectable Caines, Talwin, norvasc,","['Anaphylactic reaction', 'Blood test', 'Cardiac monitoring', 'Cough', 'Electrocardiogram', 'Flushing', 'Oxygen saturation', 'Sensation of foreign body']",1,JANSSEN,IM 1085167,NY,74.0,F,Error: Improper Storage (temperature),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PHM,,,,,,['Product storage error'],1,JANSSEN,IM 1085174,IN,58.0,F,"10 hours after injection began running a fever of 102, chilling, achy, headache. Treated with tylenol and lasted about 5 hours. Felt very tired and achy for the next 12-14 hours. Returned to work two days after feeling fine.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,"D3, Vitamin C, Magnesium, Zinc, Biotin, Lutein, Probiotic, Claritin, Metamucil",,,,Penicillin,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1085177,CA,53.0,F,"shivering, cold, feverish, muscle aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,UNK,none,no,none,Swollen injection site for DPT 2018,no,"['Chills', 'Myalgia', 'Nasopharyngitis', 'Pyrexia']",1,JANSSEN,IM 1085183,IN,53.0,F,"I had body aches, slight headache and felt drained of energy. Flu like symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PUB,Hydrochlorothiazide and Amlodipine Besylate,,Heart Murmur and high blood pressure,,allergic to Lisinopril,"['Asthenia', 'Headache', 'Influenza like illness', 'Pain']",UNK,JANSSEN, 1085185,VA,,F,"testing positive for COVID; Fever for 3 hours after the vaccine/ High temperature; Joint pain; Severe upper back pain; Headache; A spontaneous report was received from a nurse concerning a 44-year-old female patient who experienced fever for 3 hours after vaccination, headache, joint pain, and severe upper back pain. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included dulaglutide, metformin, empagliflozin, losartan, amlodipine, levothyroxine, simvastatin, allopurinol, estrogen, colchicine, calcium, zinc, multivitamin and vitamin C. On 05 Jan 2021, the patient received mRNA-1273 (Lot number 026L20A) intramuscularly for prophylaxis of COVID-19 infection. On 05 Jan 2021, patient experienced fever for 3 hours after vaccination. The patient also experienced headache, joint pain, and severe upper back pain. The patient stated her temperature was high from 05 Jan 2021 until 09 Jan 2021 when it went down. Treatment information was not provided. Follow-up received on 21 Feb 2021, from the patient's husband, included that the patient tested positive for Covid-19 on 09 Jan 2021 and was hospitalized on 11 Jan 2021. The patient never recovered from her symptoms and the patient died on 02 Feb 2021. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events Coronavirus test positive was fatal and for headache, joint pain, severe upper back pain and temperature were unknown. The cause of death was reported as Coronavirus test positive and autopsy details was unknown.; Reporter's Comments: This case concerns a 44-year-old female who was hospitalized with a serious unexpected event of COVID-19 with fatal outcome along with NS unexpected back pain and NS expected fever, headache, arthralgia. Event onset was 5 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes fatal. Autopsy results unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Testing positive for COVID",Yes,02/02/2021,Not Reported,Yes,,Not Reported,N,01/05/2021,01/05/2021,0.0,UNK,TRULICITY; METFORMIN; JARDIANCE; LOSARTAN; AMLODIPINE; SYNTHROID; SIMVASTATIN; ALLOPURINOL; ESTROGEN; COLCHICINE; CALCIUM; ZINC; VITAMIN C ACID,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Arthralgia', 'Back pain', 'Body temperature', 'COVID-19', 'Coronavirus test positive', 'Headache', 'Pyrexia']",1,MODERNA,OT 1085186,,32.0,F,"Other side effects; Anaphylaxis; Anaphylaxis; A spontaneous report was received from a nurse, concerning a 32-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 2 episodes of anaphylaxis (onset: 28 Jan 2021 and 29 Jan 2021) and other unspecified side effects. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date patient took her first of two planned doses. On 28 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient experienced the event of anaphylaxis (life threatening), within 30minutes after the second dose of vaccine. Hence, she received epinephrine and her condition did not improve so received a second dose of the same, also was treated with diphenhydramine and oxygen and sent home. Next day, on 29 Jan 2021, the patient again went into anaphylaxis, hence, received another epinephrine and was also given with prednisone due to which patient got better and was stable today. But, however, she still having other side effects but not anaphylaxis. The patient's clinical history says that on Sunday night she continued to be symptomatic with vaccine side effects. The patient was confirmed to be not pregnant. Treatment for event other side effects were unknwon. Action taken with mRNA-1273 in response to the events were not reported. The outcome of events anaphylaxis (onset: 28 Jan 2021) and anaphylaxis (onset date: 29 Jan 2021) was resolved on 29 Jan 2021. The outcome of event other side effects was considered unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Yes,Not Reported,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Adverse event', 'Anaphylactic reaction']",1,MODERNA, 1085187,AL,83.0,F,"Diarrhea; A-afib; A spontaneous report was received from an 83-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea followed by exacerbation of her A-fib (atrial fibrillation). The patient's medical history included hypertrophic obstructive cardiomyopathy. Concomitant product use was not provided. On 25-Jan-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number 011M20A) for prophylaxis of COVID-19 infection. On 01-Feb-2021 (reported a week later), the patient experienced persistent diarrhea. She stated, ""I believe it's affecting my heart"" and that ""she went into A-fib since having diarrhea."" Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The events of diarrhea and atrial fibrillation were not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,02/01/2021,7.0,UNK,,,Medical History/Concurrent Conditions: Atrial fibrillation (Went into a-fib since having diarrhea); Hypertrophic obstructive cardiomyopathy,,,"['Atrial fibrillation', 'Diarrhoea']",1,MODERNA,OT 1085188,TX,,F,"Broke the bone of my eye socket (bottom part); Broke my right-hand wrist; Broke my right-hand wrist; I slipped outside while given food to birds; A spontaneous report was received from a consumer who was a 50- year-old female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, slipped outside while giving food to birds(fall), broke her right-hand wrist (hand fracture; wrist fracture) and broke the bone of her eye (facial bone fracture). The patient's medical history was not provided. Concomitant medications reported included lisinopril and vitamins. On 30-JAN-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot: 010M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 20-FEB-2021, patient reported that she slipped outside while giving food to birds. She stated that she broke her right hand and wrist as well as the bottom part of her eye socket. The patient was scheduled to receive the second dose of mRNA-1273 on 27-FEB-2021 and was unsure as to whether or not to get it due to the fact that she had recently received a Tetanus vaccine. Treatment for the events included a cast to the right upper extremity and a tetanus shot to the right arm on 20-FEB-2021. Action taken with mRNA-1273 in response to the events was unknown. At the time of this report, the events, slipped outside while giving food to birds(fall), broke her right-hand wrist (hand fracture; wrist fracture) and broke the bone of her eye (facial bone fracture), were considered recovering/resolving.; Reporter's Comments: This case concerns a 50 year old, female patient, who experienced a serious unexpected event of Facial bones fracture, hand fracture, wrist fracture, and fall, 22 day after receiving 1st dose of mRNA- 1273 (Lot# 010M20A). Based on the mechanism of action of mRNA-1273, the events are assessed as unlikely related to mRNA-1273. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/20/2021,21.0,UNK,LISINOPRIL; VITAMINS NOS; TETANUS VACCINE,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Facial bones fracture', 'Fall', 'Hand fracture', 'Wrist fracture']",1,MODERNA,OT 1085189,MA,46.0,F,"Hearing in her right ear is now muffled; Places her finger in her right ear, it feels numb; Couldn't get off the couch; Vomiting; Dizziness; Vertigo/Felt spinning all day long; No hearing in right ear; Left earache; Beeping noise right ear; Nauseated; Neck and shoulders were also achy; Head felt like it would explode; Ears were full of pressure; Neck and shoulders were also achy; Chills; Body aches; A spontaneous report, was received from a consumer (patient), a 46 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced no hearing in right ear (deafness unilateral), ears were full of pressure (ear congestion), neck and shoulders were also achy (neck pain), left earache (ear pan), beeping noise right ear (tinnitus), hearing in her right ear is now muffled (hypoacusis), place her finger in her right ear, it feels numb (hypoaesthesia), body aches (pain), dizziness, couldn't get off the couch (asthenia), vertigo/felt spinning all day long (vertigo), chills, neck and shoulders were also achy (arthralgia), head felt like it would explode (headaches), nauseated (nausea), and vomiting. The patient's medical history included ear infection as a child, hysterectomy (5 years ago) and knee surgery (8 years ago). The patient was allergic to penicillin and sulfa drugs. Concomitant medications were not reported. On 09 Feb 2021, prior to the onset one events, the patient received the second of planned doses of mRNA-1273 (Lot number: 001A21A), intramuscularly in the left arm for the prophylaxis of COVID-19 infection. On 09 Feb 2021, after administering the vaccine, at night she started experiencing a bad reaction which includes body aches and chills. On 10 Feb 2021, in the morning, the patient head felt like it would explode, reported headaches, and her ears were full of pressure. She stated that her neck and shoulders were also achy. The patient stated that she took acetaminophen as treatment medication. On 11 Feb 2021, in the morning, the patient had a left earache and no hearing in right ear except a beeping noise. The patient also stated that she was feeling nauseated and called her primary healthcare professional and was advised to go to urgent care on the same day. The patient stated that she was prescribed prednisone (one tablet three times a week) and ear infection was ruled out. On 13 Feb 2021, the patient experienced vertigo, dizziness, but body aches were mostly gone. On 14 Feb 2021, the patient stated that it was the worst day, as she couldn't get off the couch, felt spinning all day long, and was vomiting. On 15 Feb 2021, the patient reported that she threw up in the morning and was nauseated and dizzy. The patient stated that she then went to see ear nose throat (ENT) specialist. It was reported that the findings from ENT Specialist was hearing loss in right ear and was prescribed a prednisone dose pack and unknown anti-nausea medication. On 23 Feb 2021, the patient stated that the hearing in her right ear was now muffled and can't hear high pitch in right ear. The patient stated that the hearing loss was ongoing and was still experiencing headaches. The patient stated that she currently isn't working and can't drive. The patient also stated that if she places her finger in right ear, it feels numb. The patient stated that she was scheduled to have a magnetic resonance imaging (MRI) done on 10 Mar 2021, if her hearing doesn't return. Action taken with second dose of mRNA-1273 in response to the event was not applicable. The outcome of the events, no hearing in right ear, ears were full of pressure, left earache, hearing in her right ear is now muffled, place her finger in her right ear, it feels numb, head felt like it would explode, were considered as not recovered; that of event body aches was considered as recovering/resolving; that of events neck and shoulders were also achy, beeping noise right ear, dizziness, couldn't get off the couch, vertigo/felt spinning all day long, chills, neck and shoulders were also achy, nauseated and vomiting, were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/09/2021,0.0,UNK,,Drug allergy (Sulfa); Penicillin allergy (Penicillin),Medical History/Concurrent Conditions: Ear infection (As a child); Hysterectomy (5 years ago); Knee surgery NOS (8 years ago),,,"['Arthralgia', 'Asthenia', 'Chills', 'Deafness unilateral', 'Dizziness', 'Ear congestion', 'Ear pain', 'Headache', 'Hypoacusis', 'Hypoaesthesia', 'Nausea', 'Neck pain', 'Pain', 'Tinnitus', 'Vertigo', 'Vomiting']",2,MODERNA,OT 1085190,TX,73.0,F,"heavy weight was pressuring their chest/experienced like a heavy thing was moving across their chest; hard time breathing as if earing several masks over their head/They felt their breathing was inhibited; oxygen level dropped to 80%; pulse was at 115; heart was really fastthrough the days, beating really fast and feeling it was moving up the throat given a choking feeling; A spontaneous report was received from a consumer who was a 73-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a heavy weight was pressuring their chest from the inside, and also felt like a heavy pressure coming from outside their body/Chest discomfort, like a heavy thing was moving across their chest, they had a hard time breathing as if earing several masks over their head felt their breathing was inhibited/dyspnea, oxygen level dropped to 80%/oxygen saturation decreased, pulse was at 115/ heart rate increased, felt their heart was fast trough the day regularly, for 5 days, beating really fast and feeling like it was moving up their throat, giving them a choking feeling/choking sensation. The patient's medical history included high blood pressure, and thyroid disorder. Concomitant medications included enalapril hydrochlorothiazide, simvastatin for ""cholesterol"" and a ""thyroid medication."" On 29-Jan-2021, at 0931, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 004M20A ) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 29-Jan-2021, 46 minutes after vaccine administration, patient reported that she started feeling like a heavy weight was pressuring her chest from the inside and also felt like a heavy pressure was coming from outside her body. At 1100, she stated that she experienced a feeling like a heavy thing was moving across her chest and she reportedly had a hard time breathing. Her oxygen level dropped to 80%, but by breathing intensely she managed to bring it to 84-87%. She reported her pulse to be 115. All of these symptoms lasted for 20 minutes. Later, she reported that her oxygen level returned to 90% and then eventually to 94%. However, she reported that for the next few days she felt like her heart rate was fast through the day, for about 5 days. She said that she felt like it was beating really fast and felt like it was moving up her throat, giving her a choking feeling. Since last Friday, 05-Feb-2021, she stated that she has had no more problems. Patient reached out to her HCP who denied her any post-vaccine related attention. Treatment activities for event included taking ibuprofen 600 mg after the vaccination. Action taken with mRNA-1273 in response to the events was unknown. The outcome of event, experienced a heavy weight was pressuring their chest from the inside, and also felt like a heavy pressure coming from outside their body, like a heavy thing was moving across their chest, they had a hard time breathing as if earing several masks over their head felt their breathing was inhibited, oxygen level dropped to 80%, pulse was at 115, was considered recovered/resolved.; Reporter's Comments: This case concerns a 73-year-old female who experienced serious unexpected events of Chest discomfort, dyspnea, oxygen saturation decreased along with a nonserious unexpected events of heart rate increased and choking sensation. Event onset 46 minutes after the first dose of mRNA-1273. Treatment with ibuprofen. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,UNK,ENALAPRIL+HCTZ; VASTATIN,Cholesterol blood increased (Patient reported using cholesterol medication.); Hypertension (High blood pressure); Thyroid disorder (Patient reported use of thyroid medication.),,,,"['Chest discomfort', 'Choking sensation', 'Dyspnoea', 'Heart rate', 'Heart rate increased', 'Oxygen saturation decreased']",1,MODERNA,OT 1085191,IL,85.0,M,"UTI; weakness; neck pain; A spontaneous report was received from a healthcare professional concerning an 85-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced UTI (urinary tract infection), weakness (asthenia) and neck pain. The patient's medical history was not provided. Concomitant medications were not reported. On 26-Jan-2021, the patient received the second of two planned doses of mRNA-1273 (LOT/BATCH: 029K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 21-Feb-2021, the patient went to the hospital and was admitted for two days for UTI, weakness, and neck pain. Treatment for the events was not reported. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore action taken with the drug in response to the events is not applicable. The outcome of the events, UTI, weakness and neck pain, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/26/2021,02/21/2021,26.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Asthenia', 'Neck pain', 'Urinary tract infection']",1,MODERNA,OT 1085192,IN,73.0,F,"cellultis; left lower leg turned stop-light red; swollen; itchy; A spontaneous report was received from a consumer who was a 73-year-old, female patient who received Moderna's COVID-19 vaccine and who developed cellulitis, her left lower leg turned stop-light red, swollen and itchy. The patient's past medical history included cellulitis. No relevant concomitant medications were reported. On 19-Feb-2021, approximately 2 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (LOT/BATCH: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the day of vaccination, the patient reported that her left lower leg turned stop-light red and that it became swollen and itchy. The patient was admitted to the hospital 20-Feb-2021 through 22-Feb-2021 where she was treated with intravenous vancomycin. Treatment for the event included intravenous vancomycin. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, cellulitis, her left lower leg turned stop-light red, swollen and itchy, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/19/2021,02/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Cellulitis,,,"['Cellulitis', 'Erythema', 'Peripheral swelling', 'Pruritus']",1,MODERNA,OT 1085193,CA,69.0,F,"Unconscious; Felt a bit sore at the injection site; A spontaneous report was received from a consumer and healthcare facility staff member concerning a 69 years old, female patient who experienced little bit sore at the injection site, unconscious and passed away. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. The patient experienced sore at the injection site and unconsciousness both since 22 Feb 2021. The husband of the patient performed CPR as instructed by 911 and EMT's and police performed medical procedure which included injections and electrical shock both on 22 Feb 2021. The patient died on 22 Feb 2021. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The patient died on 22 Feb 2021. The cause of death was unknown. Plans for an autopsy were not provided.; Reporter's Comments: This is a case of death of a 59-year-old, female patient who experienced injection site sore and became unconscious on the same day after mRNA-1273 administration and subsequently expired. Although critical details such as the patient's medical history and actual cause of death is lacking, based on the current available information which shows a strong temporal association with the product use, thus, a causal relationship cannot be excluded. injection sore is consistent with product safety profile and cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death",Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Loss of consciousness', 'Vaccination site pain']",2,MODERNA,OT 1085194,MI,,M,"could not breath; violent shaking in the right arm; could not walk; legs and knees were in a lot of pain/arms hurt; warm feeling over face; blurred vision in left eye; lost vision in the left eye, only had peripheral vision; sick to stomach; achy; Fever; upset stomach; legs and knees were in a lot of pain/pain in hip/knees, arms and hand joints both hurt; Hip and pelvic area had pain; feet burning; A spontaneous report was received from a consumer who was also a 70-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced upset stomach, violent shaking in right arm, legs and knees in lot of pain, could not walk and breath, fever, hip and pelvic pain, feet burning, achy and sick to stomach, warm feeling over face, loss of vision, blurred vision, and hands hurt. Medical history included hip prosthesis and COVID-19. Concomitant medications included atorvastatin calcium. On 26 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lbatch: 023M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. By noon on 26 Feb 2021, he started getting minor side effects (not specified). By that evening, he had an upset stomach. A little after 11 pm, he experienced violent shaking in the right arm. His legs and knees were in a lot of pain and he could not walk. His family called 911 because he could not breath and was admitted to the ER. A thorough check up was done (not further specified) and he had documented leg and knee pain and fever. hip and pelvic area had pain, he could not walk, his feet were burning. He also felt achy and sick to his stomach. The patient said his adverse events were similar to when he had COVID-19 but said this was worse. On 28 Feb 2021, the patient lost vison in his left eye, only had peripheral vision, along with blurred vision in his left eye. His knees, arms, and hand joint both hurt. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The events resolved on 01 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/26/2021,02/26/2021,0.0,UNK,LIPITOR,,Medical History/Concurrent Conditions: COVID-19; Hernia; Hernia repair; Hip replacement,,,"['Abdominal discomfort', 'Arthralgia', 'Blindness unilateral', 'Burning sensation', 'Dyspnoea', 'Feeling hot', 'Gait inability', 'Pain', 'Pain in extremity', 'Pelvic pain', 'Pyrexia', 'Tremor', 'Vision blurred']",1,MODERNA,OT 1085195,GA,,F,"Double pneumonia; A spontaneous report was received from a consumer (daughter of the patient) for a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and who developed double pneumonia. Patient had heart problems. No concomitant product use was reported. On 03- Feb-2021, the patient received their first dose of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date the patient developed double pneumonia. Patient was hospitalized on 26-Feb-2021. The reporter believed the hospitalization had nothing to do with the vaccine. She was just concerned about re-scheduling the second vaccine appointment. Serious ness criteria: Hospitalization Treatment information was unknown. Action taken with mRNA-1273 was unknown. The outcome of the event of double pneumonia was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/03/2021,,,UNK,,Heart disorder,,,,['Pneumonia'],1,MODERNA,OT 1085196,OH,69.0,F,"Feeling faint; Light headed; Fatigue; Diarrhea; Nausea; Vomited; Sore arm; A spontaneous report was received from a consumer concerning a 69-Years old, female patient who experienced the events syncope, dizziness, pain in extremity, diarrhoea, nausea, vomiting and fatigue. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included metformin for diabetes type 2, valsartan 25mg for high blood pressure and paroxetine for anxiety and depression. On 09 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 09 Feb 2021, the patient experienced sore arm. On 11 Feb 2021, the patient felt very bad had nausea and vomited. The patient also experience diarrhea on the same day. On 12 Feb 2021, the patient woke up with feeling faint and lightheaded. The patient reported that she cannot put anything in their mouth and experienced fatigue. The event syncope was considered to be serious with seriousness criteria - medically significant and all other events were non-serious. Action taken with mRNA-1273 in response to the events was not unknown. The outcome of the events syncope, dizziness, pain in extremity, diarrhoea, nausea, vomiting and fatigue was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,02/09/2021,0.0,UNK,METFORMIN; VALSARTAN; PAROXETINE,,Medical History/Concurrent Conditions: No adverse event,,,"['Diarrhoea', 'Dizziness', 'Fatigue', 'Nausea', 'Pain in extremity', 'Syncope', 'Vomiting']",1,MODERNA, 1085197,DE,,M,"has a whole lot of fluid; was weak and all sorts of a mess/Had been really weak; This is a spontaneous report from a contactable consumer (patient's wife) via a medical information team. An 85-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Not Provided, NDC number: Not Provided, Expiration date: Not Provided), via an unspecified route of administration on 05Feb2021 at single dose for COVID-19 immunisation. The patient's medical history included sick prior to receiving the vaccine. Concomitant medications were not reported. It was reported that, caller (75-year-old, female) and husband received the first dose of the COVID vaccine on 05Feb2021. Caller has information that the vaccination center provided that states, ""you should receive your second dose between 26Feb2021 and 01Mar2021. You should receive your second dose for maximum protection. Follow-up to receive the second dose."" Caller asked, ""where do I need to get the second shot"". Caller stated that she took her husband to the hospital on Wednesday. Caller states that her husband was already sick prior to receiving the vaccine and the hospital admission was ""not from the vaccine."" Caller states that her husband ""was weak and all sorts of a mess on an unspecified date in Feb2021."" Caller states that ""they drained fluid out of him yesterday (on an unspecified date in Feb2021) and he should be home sometime by the end of next week."" Caller was a woman who was calling to seek information about where her and her husband could go to get the second dose of the COVID vaccine. Caller states that her husband was in the hospital, but he should be home some time. Caller stated she needs to know where she can take her husband to get the second dose of the vaccine. Caller reports her husband has been in the hospital on an unspecified date in Feb2021 because he has a whole lot of fluid on an unspecified date in Feb2021. Caller states that her husband has been sick for a while, and on Wednesday she took him to the hospital. Caller reports that the hospital called her yesterday and they said they had to drain a lot of fluid out of him, and they wanted to keep him. Caller states that he had been really weak on an unspecified date in Feb2021. Caller states that this doesn't really have anything to do with the COVID vaccine. The event has a whole lot of fluid was considered as serious (hospitalization) by the consumer. The outcome of the events was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/05/2021,02/01/2021,,PVT,,,Medical History/Concurrent Conditions: Sickness,,,"['Asthenia', 'Fluid imbalance']",1,PFIZER\BIONTECH, 1085198,NJ,77.0,F,"severe blockage in intestines, with gangrene, she is in bad shape, they contributed this to the clotting; Mesenteric artery thrombosis; severe tummy ache; she is loosing weight; sore arm; body aches; This is a spontaneous report from a contactable consumer (patient's relative). A 77-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspecified route of administration in arm, on 09Feb2021, at 77 years of age, at single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date. Other than that, she was generally in good health, only on blood pressure medication and it was under control, no other issues. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine on 18Jan2021, at 76 years of age, after which she had regular sore arm and 24 hours body aches. The patient's concomitant medications included an unspecified blood pressure medication. On 09Feb2021 the patient experienced sore arm for 24 hours and little body aches; on 25Feb2021 she went out for coffee and cake, when she came back home, she had severe tummy ache after the meal, she rushed to the doctor and the doctor rushed her to the hospital on the same day. She was diagnosed with mesenteric artery thrombosis related to blood clot; she had severe blockage in intestines with gangrene (the intestines started dying), she was in bad shape and this contributed this to the clotting. The mesenteric artery thrombosis was assessed as life threatening and required patient's hospitalization on 25Feb2021. In response to the event the patient underwent an intestinal surgery: she was operated within an hour from her arrival to hospital as it was a life-threatening condition, they had to cut part of her intestines out because of gangrene. It was also reported that the patient was eating, but she was loosing weight since an unknown date. The reporter didn't know the exact weight, but maybe it was 130 pounds. At the time of the report the event ""mesenteric artery thrombosis"" had not resolved yet and the patient was still hospitalized, the events ""sore arm"" and ""body aches"" resolved on 10Feb2021 and on an unknown date, respectively, whereas the outcome of all the other events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Yes,Yes,,Not Reported,N,02/09/2021,02/09/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure high,,,"['Abdominal pain upper', 'Intestinal gangrene', 'Mesenteric artery thrombosis', 'Pain', 'Pain in extremity', 'Weight decreased']",2,PFIZER\BIONTECH, 1085199,WV,36.0,M,"I developed severe chills immediately after lifting a 40 pound object off of the floor using both arms; severe full body aches; headaches; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6200), via an unspecified route of administration in left arm on 24Feb2021 00:30 at single dose for COVID-19 immunisation. Facility type vaccine was hospital. The patient medical history was not reported. No covid prior vaccination. No known allergies. There were no concomitant medications. The patient previously took first dose bnt162b2 (lot number=EL9269, vaccine location=Left arm]) at the age of 36-year-old on 05Feb2021 11:30 PM for COVID-19 immunization. Patient did not receive other vaccine in four weeks. Patient developed severe chills immediately after lifting a 40 pound object off of the floor using both arms. The room temperature was 73 degrees. Patient put on thermal clothing, wrapped himself in a heated blanket and placed an additional blanket on top, with no relief. Patient debated calling #. Patient was afraid patient would go into shock if patient couldn't get warm. Patient finally found relief by sitting in front of a propane heater, where patient eventually slept. Patient had severe full body aches, chills and headaches for four days which patient treated with ibuprofen and Tylenol. Event onset date was 24Feb2021 23:00. AE resulted in: [Life threatening illness (immediate risk of death from the event)]. No covid tested post vaccination. Therapeutic measures were taken as a result of events (Heat therapy, tylenol, ibuprofen). The outcome of events was reported as recovering.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/24/2021,02/24/2021,0.0,PVT,,,,,,"['Chills', 'Headache', 'Pain']",2,PFIZER\BIONTECH, 1085200,VA,35.0,F,"Patient had 4 mm left frontal lobe stroke without any other known etiology on testing (heme, cardio, neuro consulting/workup); This is a spontaneous report from a contactable physician. A 35-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL9267), intramuscularly at site of left arm at 16:30 on 16Feb2021 at single dose for COVID-19 immunisation. Medical history included hypothyroidism and autism spectrum disorder (ASD) (closed 12 years ago with NO sequelae). Concomitant medication included levothyroxine and valacyclovir [valaciclovir], both received within two weeks of vaccine. The patient had 4 mm left frontal lobe stroke without any other known etiology on testing (heme, cardio, neuro consulting/workup) at 13:15 on 20Feb2021. The patient was hospitalized for this event for 2 days. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received treatment (Multiple MRI/MRI, TTE AND TEE, blood studies/holter study, new medicatinos) for adverse event. No covid prior vaccination. Covid was tested post vaccination. Covid test type post vaccination was blood test, covid test name post vaccination was Ig M/IgG with negative result on 24Feb2021. Covid test type post vaccination was Nasal Swab, covid test name post vaccination was Rapid with negative result on 24Feb2021. No known allergies. No other vaccine received in four weeks. The outcome of event was recovered/resolved with sequel.; Sender's Comments: Limited information does not allow a medically meaningful assessment for the event Stroke for BNT162B2. Details regarding the clinical symptoms, relevant test results, treatment medications and clinical course are not provided. At this time, the case is handled as related for reporting purposes. The case will be re-evaluated if more information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,2.0,Yes,N,02/16/2021,02/20/2021,4.0,UNK,LEVOTHYROXINE; VALACYCLOVIR [VALACICLOVIR],,Medical History/Concurrent Conditions: Autism spectrum disorder (closed 12 years ago with NO sequelae); Hypothyroidism,,,"['Blood test', 'Cerebrovascular accident', 'Investigation', 'Magnetic resonance imaging', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1085250,MS,40.0,M,seconds after administration patient started losing consciousness. he stated he previously experienced vasovagal syncope after flu shots. he went in and out consciousness several times over the next 5 minutes. he lost color in face and eyes closed when head dropped. his body was stabilized and kept alert with verbal and physical tests. cold compress was applied behind neck and BP monitor placed on arm. he had normal BP/pulse. skin color gradually improved as well as mental acuity. patient could stand after approx 10m and was observed for additional 30m. his phone was used to call his wife and someone came to assist getting home. said felt fine after full observation time and seemed to have made full recovery.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PHM,no meds listed,none,none,,no allergies,"['Immediate post-injection reaction', 'Loss of consciousness', 'Posture abnormal', 'Skin discolouration', 'Syncope']",1,JANSSEN,IM 1085254,NJ,90.0,M,"Severe abdominal pain unable to eat or sleep for 36 hours. He went by ambulance to the Hospital emergency room. They tried to pump his stomach but he aspirated and and went into cardiac arrest. He was revived but never regained consciousness. (The ICU Dr said that he had blood clots in his abdomen from a recent stroke. We were unaware of him having a stroke other than in 2026. The same Dr. said that he had necrosis in his lungs from aspirating. The necrosis was from his bowel dying) He was put on a ventilator and given drugs to increase his heart rate. On 3-5-21 the heart drugs were reduced and he died. I was with him when he recieved the vaccination and he was healthy, just old. I think that the shot killed him.",Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/01/2021,03/01/2021,0.0,PVT,furosemide metaprolol eliquis lisprinopril pravastatin doxazosin glimeperide omperozole diltiazem potadsium,,stroke in 2016,,,"['Abdominal pain', 'Aspiration', 'Cardiac arrest', 'Death', 'Feeding disorder', 'Gastric aspiration procedure', 'Gastric lavage', 'Gastrointestinal necrosis', 'Insomnia', 'Mechanical ventilation', 'Pulmonary necrosis', 'Thrombosis']",1,PFIZER\BIONTECH,SYR 1085261,KS,40.0,M,"Metallic taste, slight headache and elevated blood glucose numbers (normal 80-120, one hour post no food prior 243)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,PHM,"Metformin, invokana, trulicity",,Diabetic,,,"['Blood glucose increased', 'Dysgeusia', 'Headache']",1,JANSSEN,SYR 1085263,FL,63.0,F,"After receiving the vaccine, the patient experienced tickling in the throat. Benadryl was given and patient soon felt fine",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/09/2021,03/09/2021,0.0,PHM,,,,,,['Throat irritation'],1,JANSSEN,IM 1085278,IN,33.0,F,"Adverse events: Severe chills, fever, fatigue, muscle aches, joint pain, dizziness, injection site pain Treatment: Acetaminophen, ice applied to injection site, rest/sleep Duration: chills lasted about 2 hours, fever lasted about 24 hours, muscle/joint pain lasted about 24 hours, injection site pain lasted about 48 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,"Singular, Spiriva, Symbicort, Allegra, Multivitamin, Calcium, Magnesium, Vitamin D, omeprazole",Sinus infection,"Asthma, allergies, chronic sinusitis, Samter's syndrome, hypermobility",,"Betadine, penicillin, codeine, NSAIDs","['Arthralgia', 'Chills', 'Dizziness', 'Fatigue', 'Injection site pain', 'Myalgia', 'Pyrexia']",1,JANSSEN,IM 1085282,CO,20.0,F,"Headache, chills, fatigue, tiredness, blurry vision, and sleeplessness; was not able to fall asleep the night after the dose. Lots of pain and soreness at injection site. Had a severe headache the next morning (relieved with acetaminophen), and had a difficult time seeing up close for about two hours despite using my corrective lenses, which made the headache worse.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,PHM,"Trazodone, Prozac, Vyvanse, Omeprazole, Mirena IUD","Peptic ulcer, allergic reaction to gluten","Celiac disease, autoimmune gastritis (AMAG)",,"Gluten (Celiac disease), Cashews, Pistachios, Mangoes","['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Insomnia', 'Vision blurred', 'Visual impairment']",1,JANSSEN,IM 1085288,CA,67.0,F,Woke up the next morning with a neck ache. It got worse as the day went on. Around 11:00 a.m. I developed a headache. Later in the day I had chills for about 3 hours. When I woke up the next morning my neck ache and chills were gone but I had a mild headache.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,PHM,Losartin Vitamin Vitamin C Calcium,,,,,"['Chills', 'Headache', 'Musculoskeletal discomfort']",1,JANSSEN,SYR 1085295,PA,64.0,F,"Moderna Dose 1 #016M20A - pain in knees, shin bones, could not put weight on left knee, never had problems before vaccine, needed to go to ER & Orthopedic Moderna Dose 2 #048A21A - pain in right ankle, right index finger (very swelled, can?t budge rings) and pain in right and left knees",Not Reported,,Not Reported,Not Reported,,Yes,N,02/01/2021,02/08/2021,7.0,PVT,Plaquenil; Wellbutrin xl; Celexa; Klonopin; Prednisone; Vitamin D3; 81 mg aspirin; Advair;,Lupus; Autoimmune Hepatitis; Asthma; Anxiety; Depression; Kidney Stone UTI,"Lupus, Asthma, Autoimmune Hepatitis, Depression, Anxiety, Kidney stones",Moderna Dose#1 very bad knee pain,Penicillin; tetracycline; Sulphate drugs (Bactrim); Phenergan; Reglan; Imuran; Pyridium; Vicodin; Oxycodone; OxyContin;,"['Arthralgia', 'Pain in extremity', 'Peripheral swelling', 'Ultrasound scan', 'X-ray limb']",2,MODERNA,IM 1085302,WI,79.0,M,Patient was admitted to Hospital on 3/1/21. Blood Sugar of 758. Patient diagnosis with Acute respiratory failure with hypoxia and acute heart failure and Metabolic encephalopathy. Patient put on ventilator and passed away on 3/2/21 at 17:04.,Yes,03/02/2021,Not Reported,Yes,1.0,Not Reported,N,02/26/2021,03/01/2021,3.0,PVT,Aspirin 81 mg oral tablet Atorvastatin Calcium 80 MG Oral Tablet Empagliflozin (Jardiance) 10 MG Oral Tablet Fiber FluoGlimepiride 4 MG Oral Tablet Propranolol HCl (Propranolol HCl ER) 60 MG Oral Capsule Extended Release 24 Hour Sitagliptin,,"Diabetes, Hyperlipidemia, Hypertension, Hyperpotassemia, Chronic Kidney Disease, Tremors",,Lisinopril,"['Acute respiratory failure', 'Blood glucose increased', 'Cardiac failure acute', 'Death', 'Mechanical ventilation', 'Metabolic encephalopathy']",2,MODERNA,IM 1085316,PA,55.0,M,"Patient received first COVID vaccine (Moderna) on 2/4. On 2/9, patient states he had fevers, chills, headaches, and loss of taste and smell. He was tested through his workplace via Saliva PCR on 2/11, which resulted positive on 2/14. Symptoms began to resolve around the date of 2/21 for about 2 days. On 2/23, he started experiencing numbness in his fingers and toes along with severe nausea, vomiting, and diarrhea. He became so weak and ill, he presented to the hospital and was admitted on 2/26. During his hospitalization, he was seen by neurology, completed several tests including a lumbar puncture, nerve conduction study/EMG who diagnosed him with ""likely some variation of AIDP, very possible mixed demyelinating/axonal variant"".",Not Reported,,Not Reported,Yes,11.0,Yes,U,02/04/2021,02/26/2021,22.0,WRK,"Aspirin 81 mg PO daily, esomeprazole PO daily, vitamin C 1000 mg PO daily, vitamin D3 PO daily, zinc PO daily",,Gout,,Penicillins (hives/urticaria),"['Ageusia', 'Anosmia', 'Asthenia', 'Blood albumin increased', 'Blood glucose decreased', 'Blood immunoglobulin G decreased', 'COVID-19', 'Chills', 'Cryptococcus test', 'Diarrhoea', 'Electromyogram abnormal', 'Guillain-Barre syndrome', 'Headache', 'Hypoaesthesia', 'Lumbar puncture normal', 'Malaise', 'Nausea', 'Nerve conduction studies abnormal', 'Protein total increased', 'Pyrexia', 'Red blood cell count decreased', 'SARS-CoV-2 test positive', 'Treponema test negative', 'Vomiting', 'White blood cell count normal']",1,MODERNA, 1085343,IN,52.0,M,"flu-like symptoms (i.e., chills, body ache, fatigue, severe headache and slight temperature) for approximately 24 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,none,none,none,shingrix (booster shot),penicillin,"['Body temperature increased', 'Chills', 'Fatigue', 'Headache', 'Influenza like illness', 'Pain']",1,JANSSEN,IM 1085352,IN,50.0,F,Pain at the infection site. Persisted x 3 days.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,OTH,Edarbyclor 40/25,None,High Blood Pressure,,Allergic to cephalasporins,['Injection site pain'],1,JANSSEN,SYR 1085365,NY,43.0,M,"Janssen COVID-19 Vaccine EUA Nasty chills and fever started 10 to 12 hours after vaccination and continued through the night. By 24 hours after the shot, things improved. 24 to 48 hours better -- no chills/fever-- but still general fatigue. ""less than 100%"". 48+ still not fully recovered. Arm muscle still sore at injection site. Suspect will be better largely by tomorrow.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,Male multivitamin,None,None,,None,"['Chills', 'Fatigue', 'Injection site pain', 'Pyrexia']",1,JANSSEN,SYR 1085367,IN,54.0,M,"I had Covid in June - and felt the same - fever (not real high - 101), chills, nausea, no energy, headache - lasted from 7pm ish until sometime around 5am woke up sweating and only had slight headache that went away after some fluids - it was not fun at all, but didn't last too long - I didnt take any Advil until about 2 am, then could sleep. Stayed home Monday because I could, but by noon felt nearly 100%, by 6pm felt 100%.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,"Echinacea, Thistle Weed, Boron, Zinc, Ashwagandha, Magnesium, Allegra",none,none,,"Green/Red/Yellow Bell Peppers, Vicadin","['Asthenia', 'Chills', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pyrexia']",1,JANSSEN,SYR 1085375,NJ,54.0,F,"Patient presented to medical center emergency room on 02/21/2020 at 19:00, patient complained of shortness of breath and feeling fullness of her throat. Patient stated that she had Motrin 800 mg TID and Flexeril PRN due to her back pain. Patient also stated that she ate a banana after she took her medications. Her systolic blood pressure was 50, and her HR was 109, patient also stated that she had her 2 shots of Moderna Vaccine, her first shot was on 01/06 and her second shot was on 02/02. Patient was treated with: 1 Duoneb, 0.3 ML IM of epinephrine, Solumedrol 125 mg, Benadryl IV 50 mg, Normal Saline infusion IV 1000 ml/hr, and Pepcid IV 20 mg. Patient lactic acid was 10.6, WBC 24.2 and Temp 97 F, patient was diagnosed as sepsis shock and patient received: Piperacillin-tazobactam 3.375 g in D5W 50 ml IVPB (3.375 g once) Vancomycin 1 g in D5W 200 ml IVPB (1 g once). Patient pH was < 6.780 and PCO2 was 55 and bicarbonate level was 5.0, patient received Sodium bicarbonate IV 50 mEq once. Patient was not stable as her BP and HR were fluctuating patient received DilTlazem IV 2.5 mg for 2 doses. Patient received Levophed 16 mg /NS 250 ml IV. At 23:13 patient was intubated, patient received a local anesthesia through a central line of lidocaine 2% without epinephrine, and patient was transferred to the ICU to be monitored. At 00:33 CODE BLUE was called and patient became unresponsive and lost pulse while patient was brought to ICU. Patient was coded twice before ROSC, during intubation patient patient noted to have coffee-ground drainage.",Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/21/2021,19.0,PVT,,,,,No known allergies,"['Back pain', 'Blood bicarbonate decreased', 'Blood lactic acid', 'Blood pH decreased', 'Blood pressure fluctuation', 'Cardio-respiratory arrest', 'Dyspnoea', 'Endotracheal intubation', 'Heart rate irregular', 'Intensive care', 'PCO2 increased', 'Pulse absent', 'Septic shock', 'Throat tightness', 'Unresponsive to stimuli', 'White blood cell count increased']",2,MODERNA,IM 1085392,NY,66.0,F,"11 am March 8 onset of fatigue, body aches, ""brain fog"" which increase over course of afternoon and persist rest of day/evening Body temperature climbs to 99.5 in late afternoon Focused pain in hip joints, left side neck and jaw Unable to work/pursue normal daily activities entire day of March 8 Symptoms resolve as of March 9, when temp returns to normal, fatigue and aches abate",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,"Vit D, Lutein, AREDS, Magnesium, Airborn",0,GERD,,0,"['Arthralgia', 'Body temperature increased', 'Fatigue', 'Feeling abnormal', 'Gastrooesophageal reflux disease', 'Musculoskeletal disorder', 'Pain']",,JANSSEN,IM 1085393,,37.0,F,"fatigue, muscle and joint pain, chills, fever of 102, headache initial fatigue set in 5 hours after getting the shot chills lasted a few hours muscle and joint pain lasted 12 hours fever lasted a few hours headache lasted 17 hours did not take any medication to help with symptoms",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PUB,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,JANSSEN,IM 1085395,VA,47.0,F,"Around 10 PM the day of the shot, started experiencing chills, muscle aches, exhaustion and a low grade fever (99.5). Symptoms lasted approximately 36 hours. Treated with tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,"Amlodpine 5mg daily Daily multi vitamin, vitamin D",None,High blood pressure,,Gluten sensitivity,"['Chills', 'Fatigue', 'Myalgia', 'Pyrexia']",UNK,JANSSEN, 1085411,,67.0,F,Chills - Fever (100 degrees) - Weak/Tired Symptoms lasted 8-10 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,UNK,DILTIAZEM CD - XARELTO - FLECANAIDE - VIT D,,ATRIAL FIBRULATION,,CODEINE,"['Asthenia', 'Chills', 'Fatigue', 'Pyrexia']",1,JANSSEN,IM 1085413,CA,37.0,M,"patient was on treadmill at home on 3/4/21 and became shortness of breath, collaspsed, hitting head on floor. Family started CPR, Downtime prior to ED arrival 30 minutes. Arrived at ER at 8:48AM. Intubated by EMS. initially shocked 1x but otherwise was in asystole. Eventually after about 70 minutes of CPR at ER patient had no ROSC, pupils dialted and fixed and at this point pronounced dead.",Yes,03/04/2021,Not Reported,Not Reported,,Not Reported,N,03/02/2021,03/04/2021,2.0,OTH,None,none,"Hyperlipidemia, hypertension, Severe Obesity, Prediabetes, Gout of left big toe",,None,"['Autopsy', 'Cardiac arrest', 'Cardioversion', 'Death', 'Dyspnoea', 'Endotracheal intubation', 'Head injury', 'Pupil fixed', 'Resuscitation', 'Syncope']",1,PFIZER\BIONTECH, 1085425,SC,30.0,F,Headache and chills approx 12-14 hrs after dose. Treated with ibuprofen,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/09/2021,1.0,WRK,Bupropion Vyvanse Trintellix Naltrexone,No,None,,No,"['Chills', 'Headache']",1,JANSSEN,IM 1085445,NY,50.0,F,Patient complained of dizziness following vaccine for about five minutes. Vital signs monitored. Blood pressure was elevated. Advised patient to seek medical care but she declined. She stated she would call her doctor.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,PUB,high blood pressure medication and diabetes medication,Unknown,Hypertension and diabetes,,Allergic to motrin,"['Blood pressure increased', 'Dizziness']",1,JANSSEN,IM 1085451,IN,64.0,F,"Covid 19 Johnson and Johnson, first and only dose ( not found above) Fever, chills, muscle aches, headache and loose stool Symptoms onset approximately 12hrs after shot lasting 36 hours Treatment Acetaminophen No medical professional consulted",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,"Gabapentin, meloxicam, famotidine, De 3 (dry eye) Multi vitamin, Ca supplement",,Arthritis,"Shingles does #2, age 63, flulike symptoms",,"['Chills', 'Diarrhoea', 'Headache', 'Myalgia', 'Pyrexia']",1,JANSSEN,IM 1085452,WI,76.0,F,"SOB a few days after vaccination; one week later, new onset of acute exacerbation of HFrEF with subsequent respiratory failure and hospitalization",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/23/2021,02/26/2021,3.0,PVT,,,"ventricular septal defect, HTN, dyslipidemia, cystic disease of kidney, chronic pain syndrome, trigeminal neuralgia, cervical spinal stenosis, osteoporosis, and insomnia",,"Ampicillin HIVES Not Specified 6/27/2007 Cefuroxime UNKNOWN Not Specified 10/3/2016 Cefuroxime Axetil NAUSEA ONLY Not Specified 6/27/2007 Guaifenesin NAUSEA ONLY Not Specified 6/27/2007 Tetracycline NAUSEA ONLY Not Specified 3/4/2004 Tetracycline Base NAUSEA ONLY Not Specified 6/27/2007 Ace Inhibitors COUGH Low 3/4/2004 Amoxicillin HIVES LowAmpicillin HIVES Not Specified 6/27/2007 Cefuroxime UNKNOWN Not Specified 10/3/2016 Cefuroxime Axetil NAUSEA ONLY Not Specified 6/27/2007 Guaifenesin NAUSEA ONLY Not Specified 6/27/2007 Tetracycline NAUSEA ONLY Not Specified 3/4/2004 Tetracycline Base NAUSEA ONLY Not Specified 6/27/2007 Ace Inhibitors COUGH Low 3/4/2004 Amoxicillin HIVES Low 2/26/2011 Atorvastatin MYALGIA Low 2/26/2011 Codeine NAUSEA ONLY, NAUSEA & VOMITING Low 3/4/2004 Guaifenesin NAUSEA & VOMITING Low 3/4/2004 2/26/2011 Atorvastatin MYALGIA Low 2/26/2011 Codeine NAUSEA ONLY, NAUSEA & VOMITING Low 3/4/2004 Guaifenesin NAUSEA & VOMITING Low 3/4/2004","['Cardiac failure', 'Dyspnoea', 'Respiratory failure']",2,PFIZER\BIONTECH,SYR 1085461,PA,50.0,M,"Upon waking the morning after my vaccine, I experienced arthralgia, mainly in the knees, myalgia, injection site pain, head heaviness, palpitations/premature ventricular contractions, and general tiredness/malaise. All AEs lasted the entire day until I went to sleep at 10:30 PM, and all were resolved upon waking the following morning at 7:00 AM.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,PHM,"Toprol XL, Norvasc, Crestor, Zoloft, Lamical, Naltrexone, Klonopin",None,"Hypertension, depression, anxiety, overweight, alcohol use",Similar events except palpitations/PVCs after every tetanus vaccine/booster my entire life.,None,"['Arthralgia', 'Fatigue', 'Head discomfort', 'Injection site pain', 'Malaise', 'Myalgia', 'Palpitations', 'Ventricular extrasystoles']",1,JANSSEN,IM 1085468,IN,54.0,F,Low grade fever Nausea Headache Exhaustion,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,"Gabapentin,baclofen",,Incomplete spinal cord injury,,No,"['Fatigue', 'Headache', 'Nausea', 'Pyrexia']",1,JANSSEN,SYR 1085478,PA,44.0,M,"Patient has been feeling fatigued since the vaccine. On 3/8 he went to play Hockey, first time since pandemic started. He reported feeling to his friends that he felt unwell and left the ice. He was found dead, CPR started, EMS called-> had shockable rhythm (VF), shocked 10 times pre-hospital. Brought to Hospital ER and placed on VA ECMO. He is currently in the ICU setting; echo suggests possible MI but formal cath pending. Has anoxic brain injury, splenic laceration, pulmonary hemorrhage/contusions, rib fractures all related to CPR (received over an hour prior to ECMO placement). Patient may ultimately expire, he is critically ill.",Not Reported,,Yes,Yes,,Not Reported,N,02/24/2021,03/08/2021,12.0,PVT,None,None,None,,PCN,"['Brain injury', 'Cardioversion', 'Computerised tomogram', 'Critical illness', 'Echocardiogram abnormal', 'Fatigue', 'Intensive care', 'Laboratory test', 'Malaise', 'Pulmonary contusion', 'Pulmonary haemorrhage', 'Resuscitation', 'Rib fracture', 'Splenic rupture', 'Ventricular fibrillation']",2,MODERNA,IM 1085493,,54.0,M,"Chills, headache, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache']",UNK,JANSSEN, 1085498,NY,42.0,M,"12 hours post vaccine injection I had a slight fever. Fever lasted until 20 hours post injection. When measured, my temperature was 100.1. 36 hours post vaccine, I started itching and at 50 hours post vaccine the itching has turned to hives. As of right now, 51.5 hours post vaccine i still have hives.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,UNK,I am currently undergoing the FOLFOX chemotherapy regimen. The last dose of FOLFOX started Feb 24 and ended Feb 26. The vaccine was given on March 7,Currently undergoing chemotherapy treatment for colorectal cancer,,,"Childhood allergy to Penecillin, unsure if still allergic. Reaction was hives","['Pruritus', 'Pyrexia', 'Urticaria']",,JANSSEN,IM 1085499,IN,54.0,F,"Chills, fever, headache, body aches, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,"D3, B12, C, estroven",,,"Shingles vaccine. Same age, same AE",,"['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1085507,NY,69.0,M,"Sudden memory lost, confusion, disorientation.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/03/2021,03/04/2021,1.0,PHM,NO,NO,NO,,NO,"['Amnesia', 'Computerised tomogram head', 'Confusional state', 'Disorientation', 'Magnetic resonance imaging head']",1,PFIZER\BIONTECH,SYR 1085526,NJ,76.0,M,"Janssen COVID-19 Vaccine EUA Fever, Muscle Pain,fatigue, hand/arm and foot/leg pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,Ramipril 5mg; Tamsulosin 0.4 mg,none,enlarged prostrate,,seasonal,"['Fatigue', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,SYR 1085528,IN,54.0,F,"I had a headache all day during the day after the vaccination. Nothing too horrible, maybe a 5 out of 10 at the most. I took 3 extra strength Tylenol about every 4 hours to help.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,UNK,"Lisinopril, Metformin, Biktarvy, multi-vitamin, calcium with vitamin D, low dose baby aspirin",none,"hypertension, diabetes, HIV+",,none,['Headache'],1,JANSSEN,IM 1085530,IN,56.0,F,"Developed fever and chills approximately 9 hours after being vaccinated. Experienced dizziness, fatigue, and achiness the next day. Fever and other symptoms resolved by Sunday night (March 7). Still experiencing some soreness at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,"Vitamin D, calcium",,"breast cancer (diagnosed and treated in 2007-08), osteoporosis",,"ampicillin, erythromycin","['Chills', 'Dizziness', 'Fatigue', 'Injection site pain', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1085536,FL,45.0,M,"Initially Fever, Fatigue, Joint Pain. 2 days later pain in right abdomen, diagnosed with Appendicitis and had emergency appendectomy performed.",Not Reported,,Yes,Yes,,Not Reported,Y,03/05/2021,03/07/2021,2.0,OTH,"levothyroxine, potassium, metformin, flomax, tadalafil, invokana,",none,"diabetes, thalassemia",,none,"['Abdominal pain', 'Appendicectomy', 'Appendicitis', 'Arthralgia', 'Blood test', 'Computerised tomogram', 'Fatigue', 'Pyrexia']",1,JANSSEN,IM 1085545,IN,53.0,F,Sore arm at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,Non,None,No,,Sulfa,['Injection site pain'],1,JANSSEN,SYR 1085546,IN,63.0,M,"Aches, fever of 100.0 at 3:15 am. Felt better Tuesday morning",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PVT,"Metformin, Gabapentin, Glipizide, Sertraline,Pioglitazone, Omeprazole, Synthroid, Lisinopril, Niacin, Hydroxyzine, Atorvastatin, Vitamin B12, Vitamin D-3",None,"Eczema, Diabetes",,None,"['Pain', 'Pyrexia']",1,JANSSEN,SYR 1085557,IN,50.0,F,12 hours of cold chills; 18 hours of excruciating headache; nausea; vomiting. Dull headache the next day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PUB,Advil pm Humalog Lantus Jardiance Atorvastatatin Hydrochlorothiazide,None,Diabetes,,Metformin,"['Chills', 'Headache', 'Nausea', 'Vomiting']",UNK,JANSSEN, 1085570,IN,54.0,M,"Severe muscle and joint pain, fever (+1.7 degrees above typical 97.3 = 99.1), upset stomach, lethargic.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,"Duloxetine, finasteride",None,"Osteoarthritis, fibromyalgia",,None,"['Abdominal discomfort', 'Arthralgia', 'Lethargy', 'Myalgia', 'Pyrexia']",1,JANSSEN,SYR 1085572,CT,32.0,F,"**17 weeks pregnant, Due date 8/11/21, 1st pregnancy** I got the shot at 3am and was feeling fine. When I woke up my arm sore and felt really cold, my temp was 100, I called and they advised me to take Tylenol and rest. I did that and it lasted for about 24 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PUB,Multi vitamin Tylenol,,,,Latex Fruit allergy,"['Feeling cold', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,IM 1085573,FL,65.0,F,"Fever 102 degrees F, severe diarreah. Miserable",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,OTH,none,none,none,,none,"['Diarrhoea', 'Feeling abnormal', 'Pyrexia']",1,JANSSEN,IM 1085574,MN,75.0,F,"Fever, intractable nausea and vomiting, fatigue, headache, body aches and diarrhea",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/04/2021,03/05/2021,1.0,PVT,"Diflunisal, lisinopril-hctz, pantoprazole,",None,"COVID infection in November 2020, Osteoarthritis, UTI, HTN",,"PCN, Diazepam","['Diarrhoea', 'Electrocardiogram', 'Fatigue', 'Full blood count', 'Headache', 'Metabolic function test', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test', 'Troponin', 'Urine analysis', 'Vomiting']",1,PFIZER\BIONTECH,IM 1085591,SC,44.0,F,"Patient stated that after waiting 15 minutes post injection and leaving, she began to experience throat closing while driving in her car. Patient voiced that she took Benadryl immediately and the reaction began to subside. The patient also stated that he woke up Saturday evening with a large sized knot on her arm where the vaccine was administered. Patient stated that it has since gone down in size but is still fairly large.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/06/2021,0.0,PHM,"Patient takes Montelukast, Dymista, Zyrtec, Arnuity, Albuterol; Prilosec, Imitrex, Nortryptyline, Velivet.",,Patient is asthmatic.,,Patient is allergic to Codeine and Tramadol.,"['Injection site nodule', 'Throat tightness']",UNK,JANSSEN,IM 1085596,CA,46.0,F,"lost grp in left arm,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/09/2021,2.0,PHM,vitamins,,sickle cell,,,['Grip strength decreased'],1,JANSSEN,IM 1085597,IL,62.0,M,Double vision about 25 minutes after treatment. Driving home and had to pull off side if road. Lasted 2 to 3 minutes. Continued then on to home.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,OTH,none,none,none,,none,"['Diplopia', 'Impaired driving ability']",UNK,JANSSEN,IM 1085603,IN,51.0,F,"Body aches, head ache, extreme tired. Treated with rest and Tylenol/Tylenol PM",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,Collagen peptides,None,None,,KNA,"['Fatigue', 'Headache', 'Pain']",,JANSSEN,IM 1085609,IN,51.0,F,"I started to feel fatigued around 10:30/11;00 am the morning after my J&J Covid vaccine. By lunchtime, I had chills, fever, nausea, aches and slept the better part of the next 19+ hours. Day 2 after my injection, I woke up with a horrible headache. I am still weak but improving each hour.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/08/2021,1.0,OTH,Atacand Lipitor Candestartan Omeprozol Baby Aspirin Multivitamin Vitamin D Fish oil,,High blood pressure High cholesterol,,Codeine IV contrast,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1085612,TN,16.0,F,"16 year old patient was inadvertently given Janssen Covid 19 vaccine by PA. This was discovered by Regional Director, who has not been able to reach the patient or guardian, but is awaiting a call back.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/08/2021,03/08/2021,0.0,OTH,,,,,,['Product administered to patient of inappropriate age'],1,JANSSEN,IM 1085620,PA,57.0,F,"After I received the vaccine, I had severe pain in my feet and later lost sensation in both feet. I went to my PCP who who prescribed Gabapentin with plan to follow up in a few days. At follow up, my PCP witnessed loss of sensation, severe pain, and poor balance. My PCP then advised me to go to hospital. I was then admitted to hospital for further care. I was admitted 2/19/21.",Not Reported,,Not Reported,Yes,20.0,Yes,N,02/05/2021,02/13/2021,8.0,OTH,"Metformin ; Repaglinide ,vit B complex",No,Controlled type 2 Diabetes,,No,"['Balance disorder', 'Blood test', 'Electromyogram', 'Lumbar puncture', 'Magnetic resonance imaging', 'Pain in extremity', 'Plasmapheresis', 'Sensory loss']",2,MODERNA,IM 1085629,,51.0,F,Vertigo. Nausea.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,UNK,"Synthroid, Cynbalta, Synthroid, Lamotrigine",high blood pressure,dysthymia,,,"['Nausea', 'Vertigo']",1,JANSSEN,IM 1085633,IN,57.0,M,Flu like symptoms and metallic taste in mouth,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,Levothyroxine & rosuvastatin,None,None,,None,"['Dysgeusia', 'Influenza like illness']",1,JANSSEN,SYR 1085640,IN,53.0,F,"Rv day vaccine at 9:25pm and starting having symptoms around 10am next day. Body aches, headache, chills, lethargy, fatigue. Finished AM work (substitute teaching) and then came home. Minimal appetite: stuck to diet, slept 2.5 hours. Have taken 3 Advil at 4pm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,PUB,Potassium citrate Estrogen 0.05mg patch Progestin 100 mg/day,None,Kidney stones,"Minor body aches, injection site soreness with yearly flu vaccine",None,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Lethargy', 'Pain']",1,JANSSEN,IM 1085647,NY,57.0,F,"Patient received vaccine at approximately 10:50 AM. She proceeded to the observation area where she began to feel light-headed. On-site EMS from was summoned. EMS placed the woman on their gurney and began assessment (vitals and EKG). A copy of the PCR has been requested, but may not be available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,OTH,Unknown,Unknown,Unknown,,Unknown,"['Anxiety', 'Asthenia', 'Dizziness', 'Electrocardiogram abnormal', 'Hypotension']",1,JANSSEN,IM 1085648,NC,27.0,F,Severe joint and muscle pain to the point of being unable to get out of bed alone. Difficulty taking deep breaths. Deep breaths cause coughing. Severe headache and nausea to the point of having trouble standing without feeling sick. Started with a few hours of getting that vaccine and is still present. Have missed two days of work so far as a result with no symptom improvement so far.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,WRK,Nonethridrone 0.35mg Multivitamin,None,Endometriosis,,None known,"['Arthralgia', 'Cough', 'Dyspnoea', 'Headache', 'Myalgia', 'Nausea']",1,JANSSEN,IM 1085659,IA,23.0,F,"Janssen COVID-19 Vaccine EUA Chills starting at 8pm, began having a fever around 9:30 of about 99.5. Fever worsened during the night to 101. Chills continued through night. Following day fever subsided and no chills but had a horrible headache. Took ibuprofen which helped.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,UNK,Ortho Novum,,,,,"['Chills', 'Headache', 'Pyrexia']",1,JANSSEN,SYR 1085666,IN,23.0,F,"Difficulty swallowing, severe chills, high fever, and severe joint pain appeared 6 hours after the injection. Was treated with Benadryl, Tylenol, and ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PUB,Vitamin C Vitamin D3 melatonin trazodone Ritalin Zoloft birth control Allegra nasacort,None,Scoliosis Insomnia ADD Anxiety Depression,,Levoquin,"['Arthralgia', 'Chills', 'Dysphagia', 'Pyrexia']",1,JANSSEN,SYR 1085673,NM,88.0,M,Patient died 2/26/2021,Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/26/2021,3.0,PVT,1) ALBUTEROL 100/IPRATRO 20MCG 120D PO INHL INHALE 1 ACTIVE PUFF BY MOUTH FOUR TIMES A DAY . FOR BREATHING. 2) BUDESONIDE 160/FORMOTER 4.5MCG 120D INH INHALE 2 ACTIVE PUFFS BY MOUTH TWICE A DAY FOR BREATHING. R,GLUCOSE INTOLERANCE HYPOTENSION,NSTEMI - Non-ST segment elevation MI Diabetes mellitus Hypothyroid Hyperlipidemia CHF - Congestive heart failure Benign essential hypertension Chronic obstructive lung disease Osteoarthritis Obstructive sleep apnea of adult Chronic kidney disease Impaired fasting glucose Electrocardiogram abnormal,,NKDA,['Death'],1,PFIZER\BIONTECH,IM 1085674,IL,40.0,M,"""patient is observed in the recovery area pale and diaphorectic. v/s taken hr 71 initially,recheck was 51p. ,o2 sat ra 97%, b/p 100/60, resp 18. comfort provided. 13:00 v/s taken hr 80, resp 18, bp 120/80 o2sat ra 98%. still looking pale. comfort and support is provided. 1315 v/s taken hr 80,resp 20,b/p 130/80 02sat ra 100%. after comfort and support provided pt reports feeling well. 13:30 pt continues to be monitored for possible changes. patient reports feeling well. v/a taken b/p 130/80 resp 20,hr 80,o2 sat ra 100% is oriented, and released accompanied by a family member"", RN - support staff",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,OTH,,,,,,"['Hyperhidrosis', 'Pallor']",1,JANSSEN,IM 1085684,GA,72.0,M,"Developed focal seizures a little less than 2 days later. Had not experienced any seizures since those initial seizures following surgery on 4/19/20. This was first instance. Nothing else in his life was new or different, and he had been on the 500 mg bid dose of levetiracetam for a couple of months, having gradually reduced from 1000 mg bid.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,03/05/2021,03/07/2021,2.0,PVT,"levetiracetamin 500 mg bid, tamsulosin 4 mg daily, Extra-Strength Tylenol as needed for neuropathic pain, routine vitamin supplements","In recovery from a TBI/stroke and craniotomy to remove a subdural hematoma 4/19/20. Developed severe focal seizures day after surgery, so placed on levetiracetam to prevent future focal seizures.",See above. No other chronic conditions.,,"Fentanyl patch (given in 2012; severe rash on back) Not an allergy, but excessive somnolence and loss of appetite from duloxetine and amitryptiline tried briefly for neuropathic pain. Was not taking at time received vaccination. Not an allergy, but developed agitation and hallucinations from Ativan given in ER and during an EEG test on 3/7 & 8. Not an allergy, but liver enzymes climbed too high when administered Dilantin and Vimpat in hospital April 2020.","['Computerised tomogram', 'Condition aggravated', 'Electroencephalogram', 'Full blood count', 'Magnetic resonance imaging', 'Metabolic function test', 'Partial seizures']",1,PFIZER\BIONTECH,IM 1085686,LA,37.0,M,"Janssen COVID-19 Vaccine EUA Muscle and joint aches, headache, Fever 100 degrees, lethargic, trouble sleeping",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,PVT,Nasacort,,,,,"['Arthralgia', 'Lethargy', 'Myalgia', 'Pyrexia', 'Sleep disorder']",1,JANSSEN,IM 1085706,WA,37.0,M,Vaccine administered on 3/3/21 . One 3/4/21 pt stated that he had a headache but figured it was due to getting the vaccine as described during education about the vaccine. On 3/8/2021 patient awoke with nausea and vomiting. Upon void he stated his urine was dark brown. Contacted medical services. Medical assessed and the patient was then transported to Medical Center.,Not Reported,,Not Reported,Yes,,Not Reported,,03/03/2021,03/08/2021,5.0,OTH,,,,,,"['Chromaturia', 'Headache', 'Nausea', 'Vomiting']",UNK,MODERNA,IM 1085737,MD,73.0,F,"fever 100 degrees, lethargy, aches, cold symptoms, tiredness , dizziness Janssen COVID-19 Vaccine EUA",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,OTH,"melatonin, xanax, zoloft, calcium, vitamins C, D3, B12, biotin, magnesium, fiber gummies, meloxicam",none,migraine headaches,,"hayfever, animal dander, sulfa","['Dizziness', 'Fatigue', 'Lethargy', 'Nasopharyngitis', 'Pain', 'Pyrexia']",UNK,JANSSEN,SYR 1085741,IN,57.0,F,"Anaphylaxis - rash and hives from head to toes, severe itching, difficulty breathing, and chest pain. Oxygen Saturation was at 87 when I arrived. Treated with dexamethasone sod phosphate PF last given at 5:45 PM, diphenhydrAMINE (Benadryl) last given at 5:45 PM, EPINEPHrine last given at 5:45 PM, famotine last given at 6:08 PM, GI cocktail oral suspension last given at 6:44 PM, hydrocortisone last given at 8:18 PM, LORazepam last given at 5:48 and 6:45 PM, ondansetron last given at 5:48.",Not Reported,,Yes,Not Reported,,Not Reported,N,03/01/2021,03/06/2021,5.0,PVT,"Aspirin 81 MG EC tablet 1 po qd; buPropion 300 MGXL tablet 1 po qd; cholecalciferol 1000 UNIT tablet po qd; escitalopram 10 MG 1 po qd; estradiol 0.5 MG tablet 1 po qd, fish oil omega-e fatty acids 1000 MG capsule, lisinopril 10 MG tablet",None,"Elevated BP, seasonal allergies, depression",,IV Contrast Dye and Prilosec (years ago),"['Anaphylactic reaction', 'Chest pain', 'Dyspnoea', 'Full blood count', 'Metabolic function test', 'Pruritus', 'Rash', 'Troponin T', 'Tryptase', 'Urticaria']",1,PFIZER\BIONTECH,SYR 1085750,FL,57.0,F,APPENDICITIS,Not Reported,,Yes,Yes,1.0,Not Reported,Y,02/01/2021,02/25/2021,24.0,PVT,"Zoloft, calcium with vitamin D, biotin,",none,anxiety,,"sulfa, augmenten, levaquin, meloxicam,","['Appendicitis', 'Computerised tomogram']",2,PFIZER\BIONTECH,IM 1085751,MD,65.0,M,Janssen COVID-19 Vaccine EUA. Side effect has been getting tired with little exertion.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,OTH,On many prescription medications,None,"Heart disease (4 stents), type 2 diabeties, psoriatic arthritis",,None,['Fatigue'],UNK,JANSSEN,SYR 1085756,TX,35.0,F,"Severe body aches. Stiff neck muscles, unable to turn head. Tiredness. All those symptoms started before 10p on 3/8/21. 5am on 3/9 same above symptoms plus temp of 100.2. No change in body aches or stiffness. Temp at 3p was 102",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,UNK,,,,,,"['Fatigue', 'Musculoskeletal stiffness', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1085764,NC,27.0,F,"Full body shakes, chills, body aches, brain throbbing, fatigue, nerve zings, lightheaded",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/09/2021,03/09/2021,0.0,PVT,Lexapro Nitrofurantoin,Uti,Anxiety,,Amoxicillin,"['Chills', 'Dizziness', 'Electric shock sensation', 'Fatigue', 'Headache', 'Pain', 'Tremor']",1,JANSSEN,IM 1085768,MD,43.0,F,"local reaction on left arm, red, warm and 3"" red circle, increased HR 100-110 BPM (my normal is about70)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PUB,"Fluticasone/Salmeterol 113/41 mcg one puff BID, Albuterol HFA MDI PRN, Chlorthalidone 25 mg 1 tablet BID, Loratadine 10 mg QD",None,"Asthma, hypertention",,"Allergic to shellfish, no known medication allergies","['Erythema', 'Heart rate increased', 'Skin warm']",1,JANSSEN,IM 1085779,IN,55.0,M,"Pt presented with AMS. History provided by father at bedside. For 2 days after vaccine pt reported not knowing what he was doing and where he was. Father brought him to ED after having breakfast together and son didn't know how to pay or what foods he liked. Was unable to recall his father's name. Treatment: DAPT with ASA and plavix x21 days and then transition to plavix 75mg daily, atorvastatin 80mg (stroke treatment) Outcome: TBD",Not Reported,,Not Reported,Yes,,Not Reported,U,03/07/2021,03/08/2021,1.0,PVT,"atorvastatin, duloxetine, empagliflozin, glipizide, insulin glargine, lisinopril, metformin",No acute illnesses,"HTN, Depression, T2DM, Hyperlipidemia, ED",,No known allergies,"['Amnesia', 'Aphasia', 'Disorientation', 'Mental status changes', 'NIH stroke scale score increased']",1,JANSSEN,IM 1085783,CA,37.0,M,Sudden Unexpected Death - No signs or symptoms,Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,02/24/2021,03/05/2021,9.0,PVT,,,,,Lactose Intolerant,['Sudden death'],2,PFIZER\BIONTECH,SYR 1085784,WA,62.0,F,"Significant neck pain and muscle spasm 48 hours after vaccination, aseptic meningitis 3 weeks after vaccination requiring hospitalization.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/07/2021,01/31/2021,24.0,PVT,Augmentin Levothyroxine Estrogen/testosterone Nexium Lexapro Zyrtec Apple cider vinegar,salivary gland blockage,hypothyroidism GERD,,Sulfa antibiotics Latex Codeine Avocado,"['Computerised tomogram head', 'Laboratory test', 'Lumbar puncture', 'Magnetic resonance imaging head', 'Meningitis aseptic', 'Muscle spasms', 'Neck pain']",UNK,PFIZER\BIONTECH, 1085788,MI,96.0,M,"My grandpa was very lethargic after his 2nd vaccine. The following day he started acting more awake, he had a better appetite but seemed to be breathing a little funny. He was labored a bit. He went to sleep on 2/24/21 and at 230 am was dead.",Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/24/2021,2.0,MIL,"Vitamin D 10mcg, , Simvistatin 20mg, ferrous sulfate 325 mg, Novolin 20 units a day, Lisinopril 2.5mg",No,"diabetes, hypertension",,No allergies,"['Death', 'Dyspnoea', 'Lethargy', 'Respiration abnormal']",2,MODERNA,IM 1085794,CO,41.0,F,"rash all over upper torso and arms noticed within first couple hours after administration, pt called md and was counseled to take benadryl and watch for further symptoms. Pt states she's fine and no further problems beside the rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,PHM,zolpidem ER 12.5 (1qhs) tramadol 50 mg (1 bid) prazosin 1 mg (2 qhs) norco 7.5/325 (1 bid) lamictal 25mg (4 qhs) tizanidine 4 mg (1 qhs) nurtec and imitrex prn (not used recently),sinus infection 3 weeks ago,none,"flu shot- anaphylaxis (unknown age, vaccination type)",penicillin mushroom (fungus- mold based) flu shot (not on documentation),['Rash'],1,JANSSEN,IM 1085801,FL,41.0,M,Patient was given dose that was higher than recommended dose due to error in measurement. Patient received approximately 0.6 to 0.65ml instead of 0.5ml dose. Patient has not experienced adverse effects due to the increased dose at this time.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,,NONE,UNKNOWN,,NONE,"['Incorrect dose administered', 'No adverse event']",1,JANSSEN,IM 1085812,MN,30.0,F,"redness below injection site, warm, mild soreness and tender",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/09/2021,4.0,OTH,Advil,none,,,Sulfa,"['Discomfort', 'Erythema', 'Skin warm', 'Tenderness']",1,JANSSEN,SYR 1085813,NE,40.0,M,"began with dehydration - frequent urination, low fever - up all night due to stomach issues very tired all of the time, drinking unreal amounts of water developed dangerously high blood sugar over the next week - diagnosed with diabetes on March 1",Not Reported,,Yes,Not Reported,,Yes,N,02/19/2021,02/21/2021,2.0,PUB,"Keppra, Tegretol, Vitamin D, Colestipol",,"Multiple Sclerosis, total colectomy due to ulcerative colitis",,"Penicillin family, dilantin, interferon","['Abdominal discomfort', 'Blood glucose increased', 'Dehydration', 'Fatigue', 'Glycosylated haemoglobin increased', 'Pollakiuria', 'Pyrexia', 'Sleep disorder', 'Thirst', 'Type 2 diabetes mellitus']",2,PFIZER\BIONTECH,SYR 1085815,ID,87.0,F,"Pt experienced syncope and collapse, was admitted for pericardial effusion without cardiac tamponade. Treated for suspected inflammatory pericardial effusion with colchicine 0.6 mg daily for 3 months, ibuprofen 600 mg 3 times daily for two weeks. Patient was discharged home from hospital in good condition 2 days after admission, scheduled for follow-up with cardiology. Additionally pt was treated for a scalp laceration from collapse with staples to posterior scalp.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/09/2021,02/16/2021,7.0,PVT,"albuterol, amlodipine, calcium carb/vitamin D3/minerals, duloxetine, ferrous sulfate, gabapentin, hydrocodone-acetaminophen, levothyroxine, loratadine-pseudoephedrine, naproxen sodium, omeprazole, simvastatin, valsartan, vitamin D3, zolpide",,"arrhythmia/palpitations, asthma, essential hypertension, osteoarthritis of the lumbar spine, hyperlipidemia, hypothyroidism",,"procainamide, procaine, lisinopril, promethazine","['Aortic dilatation', 'Arteriogram carotid normal', 'Blood thyroid stimulating hormone normal', 'Computerised tomogram head normal', 'Computerised tomogram neck', 'Computerised tomogram thorax normal', 'Echocardiogram abnormal', 'Electrocardiogram normal', 'Pericardial effusion', 'Skin laceration', 'Skin swelling', 'Suture insertion', 'Syncope', 'Troponin normal']",1,PFIZER\BIONTECH,IM 1085822,AR,51.0,F,"""shoulder problems"" thought to be ""frozen shoulder"" per her PA",Not Reported,,Not Reported,Not Reported,,Yes,N,01/12/2021,01/13/2021,1.0,PVT,unknown,unknown,unknown,,codeine,['Periarthritis'],2,PFIZER\BIONTECH,IM 1085828,FL,34.0,F,"Fever (102.8), body aches, headache, chills/hot",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,PHM,Norgestimate and Ethinyl Estradoil (birth control),None,None,,None,"['Chills', 'Feeling hot', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1085836,SD,56.0,F,Patient's entire Left Arm became numb shortly after receiving her vaccination,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,PVT,,,,,,['Hypoaesthesia'],1,JANSSEN,IM 1085845,NY,27.0,F,"No symptoms after receiving the shot. Next day had a 102.8 fever, chills, body aches & head pressure.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,OTH,Have an IUD. No other meds taken.,None.,None.,,Amoxicillin,"['Chills', 'Head discomfort', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1085854,WI,86.0,F,"Received 2nd COVID 19 vaccine 3/4/21. On 3/5/21, was tired, but otherwise did okay. On morning of 3/6/21, she awoke short of breath, felt hot, was a little nauseated, and did not take her medication. She has gradually grown more short of breath and distressed since then. She appears weak, distressed with tachycardia and hypoxemia. Bilateral pneumonia seen on xray. She arrived to the ED in A-fib with RVR HR 150's. O2 90% on 12L NRB. After IV access was obtained and labs drawn patient was transitioned to BiPAP setting 10/5 and 30% per MD at 1300. Her saturations were not maintaining above 90% and O2 was titrated up to achieve a O2 % > 90. She was given a loading dose of Diltiazem per protocol and started on a DilIazemt gtt, the drip was titrated up to max 15 to achieve target HR <100. Her BP remained stable during this course. She received a bolus of NS. 1 gram of Tylenol via IV. 1 gram of Rocephin infusing upon transfer. D5LR infusing at 200 upon transfer.During her course in the ED she was able to communicate with staff when asked questions.",Not Reported,,Not Reported,Yes,3.0,Not Reported,,03/04/2021,03/06/2021,2.0,PVT,,,,,,"['Asthenia', 'Atrial fibrillation', 'Bilevel positive airway pressure', 'Chest X-ray abnormal', 'Dyspnoea', 'Emotional distress', 'Fatigue', 'Feeling hot', 'Hypoxia', 'Laboratory test', 'Nausea', 'Pneumonia', 'Tachycardia']",2,MODERNA,IM 1085865,OH,,M,DEATH 2/23/21,Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,01/29/2021,,,PUB,Unknown,,unknown,,Unknown,['Death'],1,MODERNA,IM 1085873,ID,75.0,F,Anaflipic shock signed wavier to get shot. scared if dont get shots,Not Reported,,Not Reported,Not Reported,,Yes,Y,02/27/2021,02/27/2021,0.0,PUB,,,,flew shot,has allergies to vaccines. she had anphliptic shock on first Phizer dose on feb 7 2021 at 9:30 am had to sign a wavier to get 2nd,['Fear of disease'],2,PFIZER\BIONTECH,SYR 1085875,IN,55.0,F,Aches in upper torso muscles,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/08/2021,2.0,OTH,"Venlafaxine 75mg, omega 3, vitamin D",None,None,,No known,['Myalgia'],UNK,JANSSEN,SYR 1085882,IN,54.0,F,"I developed some flu symptoms (chills and aches) around 11 pm the day of the shot, and these symptoms lasted about 36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,Chewable multivitamin and mineral tablet,None,"Some osteoarthritis in hands, feet and knees",Muscle aches with flu shots,None known,"['Chills', 'Influenza like illness', 'Pain']",1,JANSSEN,IM 1085894,MD,29.0,F,"Janssen COVID-19 Vaccine EUA Chills & fever for 3 hours, 6 hours post shot Entire body aches for 12 hours Headache Tiredness Muscle & joint pain/weakness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,UNK,Prenatal vitamins,None,None,,Sulfate,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Muscular weakness', 'Myalgia', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1085895,IN,51.0,M,Covid like symptoms Headache Muscle ache Fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,Synthroid Metforman Protonix,,,,Codene,"['Fatigue', 'Headache', 'Myalgia']",1,JANSSEN,IM 1085900,IN,58.0,M,"Lethargic, chills, loss of appitite",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,"Atorvastatin, losartin, naloxetrine",None,High blood pressure,,None,"['Chills', 'Decreased appetite', 'Lethargy']",1,JANSSEN,SYR 1085902,VA,37.0,M,I started to feel extreme fatigue around noon the day after but what I found very concerning is I lost probably 80-90% of the strength in my arms. I couldn't palm a ball i had for the kids which i normally can easily. I had chills and nausea as well. I can't really remember much from that day and it feels like a big blur. I woke up the next day feeling very irritable with brain fog. Today its gotten better and I am hoping tomorrow I will be back to normal.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,Zinc 15mg a day,none,Detoxed off of suboxone in March of last year so i have been mentally and phsyically recovering from that.,,none,"['Chills', 'Fatigue', 'Feeling abnormal', 'Irritability', 'Muscular weakness', 'Nausea']",1,JANSSEN,IM 1085910,,21.0,F,"4 hours after vaccine I experienced vasovagal (passed out), for the rest of the day after I experienced fever, chills, fatigue, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,"Prozac, multi vitamin",none,exercise induced asthma,,none,"['Chills', 'Fatigue', 'Loss of consciousness', 'Pain', 'Presyncope', 'Pyrexia']",1,JANSSEN,SYR 1085915,NJ,61.0,F,"-severe shaking / chills for 2 hours ...so much so that I could not get warm and my muscles hurt from shaking so much -headache, body ache , both 24 hours -soreness at sight of injection",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,SCH,Atorvastatin Escitalopram,None,None,,erythromyacin,"['Chills', 'Feeling cold', 'Headache', 'Injection site pain', 'Myalgia', 'Pain', 'Tremor']",1,JANSSEN,IM 1085917,CO,60.0,F,"Horrendous headache starting 13 1/2 hrs later. Then nausea, and I passed out. Came to and had extreme chills. After the 24 hr mark, just tired and had to stay in bed. Today 3/9, all good.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,"Selenium, zinc, vitC, calcium but all of those after the shot",nothing,none,,"Allergy to ""laughing gas"", n...... ?","['Chills', 'Drug hypersensitivity', 'Loss of consciousness', 'Nausea']",1,JANSSEN,IM 1085918,IN,55.0,M,"Received vaccine at 8:30am . Just before sleep at 10 pm , Started getting chills and slight nausea. Went to work next day still feeling rundown with muscle fatigue but chills not as bad . Went home after full work day to rest then go to bed early. Next day felt fine . All in all I had a great experience . The people (organizers and others ) at the location that day did a fantastic job. Easy Breezy .",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,None,None,No,,No,"['Chills', 'Muscle fatigue', 'Nausea']",1,JANSSEN,IM 1085951,GA,19.0,M,"Extreme inter cranial pressure, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,PHM,Vyvance 40mg,None,None,,None,"['Headache', 'Intracranial pressure increased']",1,JANSSEN,SYR 1085954,IN,52.0,M,"Severe chills, headache, mild nausea and diarrhea, and fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,PVT,"Kirkland Aller-tec , Acidophilus",,,,,"['Chills', 'Diarrhoea', 'Fatigue', 'Headache', 'Nausea']",UNK,JANSSEN, 1085957,TN,19.0,F,"extend amounts of pain in the head, mouth, legs inability to walk",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,PVT,actemra,RA arthritis,"RAarthritis, seizures",,none,"['Gait inability', 'Headache', 'Oral pain', 'Pain in extremity']",1,JANSSEN,SYR 1085964,MN,65.0,M,Rash starting under the breast area around to the side and up to the armpit on both sides of body,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/09/2021,2.0,OTH,"Valsartan-HCTZ, zolpidem, prevastatin, iron, calcium, vitamin D, vitamin E, magnesium, omega 3-6-9, vitamin B-12,",,Type 2 hypertension,,"Toradol, ace inhibitors, ibuprofen",['Rash'],UNK,JANSSEN, 1085965,IL,76.0,F,Experienced right side aside pain 3 days after vaccination and broke out with shingles rash 6 days after vaccination,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/18/2021,02/22/2021,4.0,SCH,"Xeralto, Cardizem, Preservision Ireds 2",AFIB and Back ache 2 days prior to the date of vaccination may have been from shoveling snow or onset of shingles .,AFIB,,None,"['Flank pain', 'Herpes zoster', 'Pain']",1,PFIZER\BIONTECH,IM 1085968,OH,38.0,F,Extreme fatigue and nausea 6w6d pregnant at time of vaccine 2 previous healthy full term pregnancies,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,UNK,Daily multi vitamin,N/a,N/a,,N/a,"['Exposure during pregnancy', 'Fatigue', 'Multiple pregnancy', 'Nausea', 'Vaccination complication']",1,JANSSEN,SYR 1085973,ND,41.0,F,"2/3/2021: Within the first 24 hours patient c/o fever, headache and rash to bilateral legs. (Patient took Benadryl prior to receiving vaccine). 2/9/2021: Patient states she has rash on bilateral legs with mottling that was worse then before. She states the rash spots blistered and are no longer painful, but still present, like little red dots at almost every hair follicle. 3/9/2021: Patient states the red bumps/rash is still present with mottling on bilateral lower legs; however, they are not painful and do not itch at this time.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/02/2021,02/03/2021,1.0,PVT,"Probiotic, Albuterol Sulfate HFA Inhaler, Colace, vitamin B-12, cyclobenzaprine, duloxetine, phentermine, and sumatriptan succinate.",None.,"Asthma, Urinary incontinence, obesity and history of broken back.",Initial Modena COVID Vaccine on 01/05/2021. Patient had been advised not to get second dose; she insisted on getting 2nd dose as,"Percocet, Tramadol and Sulfa drugs.","['Headache', 'Livedo reticularis', 'Pyrexia', 'Rash', 'Rash erythematous', 'Rash vesicular']",2,MODERNA,IM 1086014,FL,,U,"Muscle break down; Loss of strength; Easy fatigue-ability of the muscles; A spontaneous report was received from a Healthcare Professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events loss of strength, muscle break down, easy fatigue-ability of the muscles. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, after the first dose of mRNA-1273 patient experienced loss of strength, muscle break down, easy fatigue-ability of the muscles. Treatment details received for the event was not provided Action taken with mRNA-1273 in response to the events was not reported. The events, outcome of events include loss of strength, muscle break down, mild rhabdo, easy fatigue-ability of the muscles was not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Asthenia', 'Muscle fatigue', 'Rhabdomyolysis']",1,MODERNA, 1086015,,,U,"Lost consciousness; A spontaneous report, was received from a pharmacist, concerning a patient of unknown age and gender, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced loss of consciousness. The patient's medical history was not provided. Concomitant medications were not reported. On an unknown date, prior to the onset of the event, the patient received their unknown planned doses of mRNA-1273 (lot number: unknown), intramuscularly for the prophylaxis of COVID-19 infection. On an unknown date, the pharmacist stated that they had a possible adverse reaction where patient lost consciousness shortly after receiving the vaccine. The patient was transported to the hospital by emergency medical services (EMS). Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event, loss of consciousness, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of loss of consciousness, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Loss of consciousness'],1,MODERNA,OT 1086016,TX,52.0,F,"Bronchitis; Cough; A spontaneous report was received from a consumer concerning an unknown age, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed bronchitis and cough. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 003L20A) intramuscularly for prophylaxis of COVID-19 infection. On Unknown date, the patient have bad lungs and developed bronchitis which is considered as Medically Significant Event and cough. Treatment for the events included antibiotics for 6 days, albuterol, Pertussin AC and Z-Pack. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events, bronchitis and cough, was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Bronchitis', 'Cough']",1,MODERNA,OT 1086017,IA,79.0,F,"Couldn't get up; Couldn't breathe; Lost voice; Felt very tired; A spontaneous report was received from a consumer concerning a 79 years old, female patient who received Moderna (mRNA-1273) vaccine and experienced couldn't get up/mobility decreased, couldn't breathe/dyspnoea , lost voice/aphonia and felt very tired/fatigue. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 13 Feb 2021, approximately three days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 022M20A) in the left arm for prophylaxis of COVID-19 infection. 15 Feb 2021, the patient couldn't breathe, felt very tired, lost her voice, couldn't get up, and was hospitalized following a visit to urgent care. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, Dyspnoea, Fatigue, Aphonia, Movement disorder and Hospitalization was unknown.; Reporter's Comments: This case concerns a 79-year-old female who was hospitalized with serious unexpected events of dyspnea, mobility decreased, and aphonia and a serious expected event of fatigue. The events occurred 3 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/13/2021,02/15/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Aphonia', 'Dyspnoea', 'Fatigue', 'Mobility decreased']",1,MODERNA,OT 1086018,CA,67.0,M,"Bell's Palsy; voice was sort of ugly; A spontaneous report was received from a consumer who is a 67-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and his voice was sort of ugly/dysphonia and Bell's palsy/facial paralysis. The patient's medical history included hypertension, triple bypass, operation in stomach and intestine and depression. No relevant concomitant medications were reported. On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection. On 29 Jan 2021, the patient stated he woke up at 0800 and noticed his voice sounded ugly. When he looked in the mirror his face looked crooked. The patient went to the hospital and was diagnosed with Bell's palsy. The patient stated he was discharged home the following day. He was given unspecified steroids. Treatment information included unspecified steroids. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, voice was sort of ugly/dysphonia and Bell's palsy/facial paralysis, were considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/28/2021,01/29/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Dysphonia', 'Facial paralysis']",1,MODERNA,OT 1086019,TX,68.0,F,"Kidney stone; A spontaneous report was received from a consumer, concerning a 68-years old female patient, who was administered Moderna's COVID-19 vaccine and developed kidney stones. The patient's medical history was not provided. The patient was not taking any concomitant medications. On 20 Jan 2021, approximately 30 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) in the right arm for prophylaxis of COVID-19 infection. The patient stated that she went to Emergency room (ER) on 18 Feb 2021 for kidney stone. The patient was treated with flomax, tylenol with codeine, motrin 600mg, zofran ODT. The patient wanted to know if she can still take her Flomax and get 2nd dose. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, kidney stone was unknown.; Reporter's Comments: This case concerns a 68-year-old female who experienced serious unexpected event of Nephrolithiasis. The events occurred 30 days after the first dose of mRNA-1273. Treated with Flomax, Tylenol with Codeine, Motrin, Zofran. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,02/18/2021,29.0,UNK,,,Medical History/Concurrent Conditions: No adverse reaction (No reported medical history),,,['Nephrolithiasis'],1,MODERNA, 1086020,OK,70.0,F,"Bloody stool; Stool with bad rotten egg smell to it; Stomach started rolling; Facial tremors around right eye; A spontaneous report was received from a consumer concerning a female patient of 70 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced facial tremors around right eye, stomach started rolling, bloody stool and stool with bad rotten egg smell. The patients medical history included asthmatic spasmodic dysphonia. No relevant concomitant medications were reported. On 27 Jan 2021, the patient received their first of two planned dose of mRNA-1273 (Lot number: 042L20A) vaccine in the left arm for prophylaxis of COVID-19 infection. On 24 Feb 2021, the patient received their second of two planned dose of mRNA-1273 (Lot number: 011A21A) vaccine in the left arm for prophylaxis of COVID-19 infection. On 24 Feb 2021, approximately 5 hours after receiving the second dose, the patient's stomach started rolling, and she experienced bloody stool with bad rotten egg smell and facial tremors around right eye. Treatment information for the events included Tylenol. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome for the events was not provided.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,02/24/2021,34.0,UNK,,Spasmodic dysphonia (asthmatic Spasmodic dysphonia),,,,"['Abdominal pain upper', 'Abnormal faeces', 'Haematochezia', 'Muscle twitching']",1,MODERNA,OT 1086021,MD,75.0,M,"Possible Stroke; Unable to speak/Lack of pronunciations; Fatigue; A spontaneous report was received from a health care professional concerning 75-years old male patient who experienced stroke (Cerebrovascular accident), unable to speak/ lack of pronunciations (Speech disorder) and fatigue (Fatigue). The patient's medical history included heart attack. Concomitant medications included included Metoprolol, HCTZ, Irbesartan, and Aspirin. On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L201A) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On 05 Feb 2021, approximately four days prior to the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On 06 Feb 2021, the patient experienced fatigue. On 09 Feb 2021, the patient experienced the events stroke and unable to speak/ lack of pronunciations. The events resulted in hospitalisation as seriousness criteria. The patient was admitted to the hospital on 09 Feb 2021. The patient was moved to ICU for 24 hours, and was the patient was discharged from Hospital on 11 Feb 2021. Treatment for the event included Eliquis and 80 mg chewable aspirin. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events is not applicable. The events stroke, unable to speak/ lack of pronunciations and fatigue were considered as recovered/resolved.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Of note, the patient has a pre-existing history of heart attack which is a strong confounder for the reported CVA and speech disorder. Fatigue is consistent with the known safety profile of the vaccine.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/08/2021,02/06/2021,29.0,UNK,METOPROLOL; HCTZ; IRBESARTAN; ASPIRIN [ACETYLSALICYLIC ACID],,Medical History/Concurrent Conditions: Heart attack,,,"['Aphasia', 'Cerebrovascular accident', 'Fatigue']",2,MODERNA,OT 1086022,AZ,65.0,F,"Chest cold; Bad sinus and chest cold; Sore from head to toe; A spontaneous report was received from a reporter(consumer) concerning a 65-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest cold/lower respiratory tract infection, bad sinus/sinusitis and sore from head to toe/pain. The patient's medical history was not provided. No concomitant product use was reported. On 18 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: not provided) in the left arm intramuscularly for prophylaxis of COVID-19 infection. On 20 Feb 2021, the reporter stated the patient had severe side effects. The patient had a bad sinus and chest cold and felt sore from head to their toes. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, chest cold/lower respiratory tract infection, bad sinus/sinusitis and sore from head to toe/pain, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/20/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Lower respiratory tract infection', 'Pain', 'Sinusitis']",1,MODERNA,OT 1086023,CA,,F,"UTI (Urinary Tract Infection); A spontaneous report was received from a 79-year-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection (UTI). The patient's current history included fibromyalgia and lymphoma. No relevant concomitant medications were reported. On 30 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch No.007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date (weeks after the vaccination), the patient experienced urinary tract infection after receiving first dose of vaccination. On an unspecified date, she also reported that she felt better. Action taken with mRNA-1273 in response to the event was unknown. The event, urinary tract infection, was considered resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. Elderly age, female gender and underlying lymphoma are considered risk factors.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,,,UNK,,Lymphoma,Medical History/Concurrent Conditions: Fibromyalgia,,,['Urinary tract infection'],1,MODERNA,OT 1086024,NJ,55.0,M,"bell's palsy or could of had a stroke; mouth drooping; speech was a little slurred; could not smile, could not open mouth to eat; right eye started tearing up and was watery; A spontaneous report was received from a consumer concerning a 55 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Facial paralysis, Lacrimation increased, Dysarthria and Facial discomfort. The patient's medical history was not provided. Relevant concomitant medications were not reported. On 05-FEB-2021, prior to the onset of the events, the patient received their first dose of two planned dose of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection. On 05-FEB-2021, the patient experienced Lacrimation increased. On 06-FEB-2021, the patient experienced Facial paralysis (mouth drooping), Facial discomfort. On 08-FEB-2021, the patient experienced Facial paralysis. The patient reported that he went to the doctor who said it could be bell's palsy or could had a stroke, and recommend he go to hospital to have it checked. The Patient reported that he has not gone to the hospital at the time of this report. No Laboratory details were provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. At the time of this report, the outcome of the event's Facial paralysis, Lacrimation increased, Dysarthria and Facial discomfort was considered as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"[""Bell's palsy"", 'Dysarthria', 'Facial discomfort', 'Facial paralysis', 'Lacrimation increased']",1,MODERNA,OT 1086025,WI,,F,"Losing eyesight in one eye; Has scratched cornea; She developed Bell's Palsy; She developed shingles; A spontaneous report was received from a relative concerning a 91-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed shingles, Bell's Palsy, losing eyesight in one eye, and scratched cornea. The patient's medical history included blind in one eye after laser surgery. Concomitant medications include vitamin d, equate arthritis medicine, losartan potassium, and eye vitamins. On 30 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly for prophylaxis of COVID-19 infection. On 09 Feb 2021, the patient developed shingles and Bell's Palsy. The patient was in the process of losing eyesight in one eye, on the side affected by the Bell's Palsy. The patient also has a scratched cornea. The patient went to the emergency room on 12 Feb 2021. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was unknown.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the start date of the event and excluding all other etiologies, a causal relationship with the events of shingles Bell's Palsy cannot be excluded. However, causality with scratched cornea and losing eyesight in one eye is unlikely. The scratch is most likely due to a trauma and can impair vision. No further information is expected and follow up consent was denied.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,02/09/2021,10.0,UNK,VITAMIN D [COLECALCIFEROL]; EQUATE 8HR ARTHRITIS PAIN RELIEF; LOSARTAN POTASSIUM; VITAMINS NOS,"Blindness, one eye (Blindness in one eye after laser surgery)",Medical History/Concurrent Conditions: Eye laser surgery (Blindness in one eye after laser surgery),,,"[""Bell's palsy"", 'Blindness', 'Corneal abrasion', 'Herpes zoster']",1,MODERNA,OT 1086026,MI,,F,"Blood pressure was 180/101; numbness on whole left side of body; tingling; A spontaneous report was received from a consumer concerning a 68 years-old, female patient who received Modern's COVID-19 vaccine (mRNA-1273) and hospitalized for blood pressure that was 180/101 and experienced numbness on whole left side of body, and tingling. The patient's medical history included hypertension, allergies to penicillin, IV contrast (highly allergic, has to be pre-medicated if uses it 2-3 days before), and sulfa, and unspecified issues with sodium. Concomitant product use included blood pressure medication. On 24 Feb 2021 at 09:45 am, prior to the onset of the events, the patient received the first dose of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 24 Feb 2021, approximately 2 hours after receiving the dose at 11:00 am, the patient's left side started going numb. The patient went home at 02:30 pm and took some Motrin, but still had numbness and tingling. At around 07:00 pm same day, the patient reported blood pressure was 180/101 beats per minute. Patient reported taking prescribed blood pressure medicine prior to getting the vaccine on 24 Feb 2021 and Motrin after the vaccination on 24 Feb 2021 in order to stop the numbness. In the morning of 25 Feb 2021, patient's blood pressure was very high until 04:00 am; therefore, patient went to the emergency room (ER). At the hospital, they were very concerned about patient's blood pressure because it remained high. The patient thought the numbness and tingling would stop but they didn't. Patient denied numbness in arms; but felt it in legs and all up left side. Due to prior ""issues with sodium"", patient had to be treated for sodium levels at the hospital. Patient was discharged out of the hospital on 26 Feb 2021. All tests came back normal. Numbness on side and tingling went away. The patient believed reaction was due to the vaccine even though it was temporary. Treatment information included Motrin. Action taken with mRNA-1273 in response to the events is not reported. The events blood pressure was 180/101, numbness on whole left side of body, and tingling were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events approximately 2 hours after receiving the dose, a causal relationship cannot be excluded. However, patient's hx of hypertension, allergies to penicillin, IV contrast and sulfa, and issues with sodium are confounding factors that may play a possible contributory role providing an alternative explanation.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/24/2021,02/24/2021,0.0,UNK,,"Allergy to intravenous contrast media (highly allergic, has to be pre-medicated 2 to 3 days before use); Drug allergy (Sulfa drugs); Hypertension (approximately 30 years); Penicillin allergy",Medical History/Concurrent Conditions: Sodium abnormal NOS,,,"['Blood pressure measurement', 'Hypertension', 'Hypoaesthesia', 'Paraesthesia']",1,MODERNA,OT 1086027,,79.0,F,"Passed out; Things were going downhill; Dizzy; Injection site was painful; Fatigued; Muscle pain; Joint pain; Nausea without vomiting; Low grade fever; A bit of an ache in injection arm; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: things were going downhill, injection site was painful, fatigued, muscle pain, joint pain, nausea without vomiting, low grade fever, dizzy, passed out, and a bit of an ache in her injection arm. The patient's medical history was not provided. No concomitant medications were reported. On 19-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 032L20a) intramuscularly for prophylaxis of COVID-19 infection. On 19-Feb-2021, the patient received the vaccine around noon and by the evening she could tell things were going downhill. She went to bed early, and throughout the night the injection site was painful, she was fatigued, she had muscle pain, joint pain, nausea without vomiting, and a low grade fever. The patient got up at night to go to the bathroom and got dizzy and passed out. She said she was passed our for barely a minute and when she came too she laid there for a bit before she went back to bed with her husband's help. All day on Saturday 20-Feb-2021 the patient was in bed but by that evening she was able to get up and walk out of the bedroom. On Sunday night 21-Feb-2021, she was able walk up stairs without huffing and puffing and felt much better. The patient states they have recovered from it all except sometimes when doing yoga, they can feel a bit of an ache in the injection arm. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The outcome of the events things were going downhill, injection site was painful, fatigued, muscle pain, joint pain, nausea without vomiting, low grade fever, dizzy, and passed out, were considered recovered/resolved. The outcome of the event, ache in injection arm, was unknown.; Reporter's Comments: This case concerns a 79 Y/O F with a serious unexpected event of loss of consciousness along with NS unexpected dizziness, feeling abnormal, pain in extremity, and NS expected fever, fatigue, myalgia, arthralgia, nausea, vaccination site pain. Event onset the same day as second dose mRNA-1273. Events resolved except arm pain. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Arthralgia', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Loss of consciousness', 'Myalgia', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Vaccination site pain']",2,MODERNA,OT 1086028,CA,96.0,M,"Cellulitis on chest; Swollen; Tender; Red; Chills; Fever; A spontaneous report was received from a consumer concerning a 96 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, fever, chills and injection site swelling, tenderness, and redness. The patient's medical history included serving as an employee, episodes of days with fever, feeding tube, Pulmonary issues and cellulitis on arm.. Concomitant medication included triamcinolone acetonide cream 0.1%, Tessalon and Robitussin. On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030M20A) in his left arm for prophylaxis of COVID-19 infection. On an undisclosed date, the patient experienced injection site swelling, tenderness, and redness. On 24 Feb 2021, the patient experienced chills. Vital signs included a temperature of 103.9 degrees Fahrenheit. Also, his sputum had some blood in it. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was unknown.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the start date of the event and excluding all other etiologies, a causal relationship with the events cannot be excluded. Fever, chills injection site swelling, tenderness and redness are consistent with the known safety profile of the mRNA-1273 vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/24/2021,21.0,UNK,TRIAMCINOLONE ACETONIDE; TESSALON; ROBITUSSIN 12 HOUR COUGH RELIEF,Cellulitis of arm; Feeding tube user; Fever (Days (never diagnosis)); Lung disorder NOS (Pulmonary issues (uses tessalon and robitussin)),Medical History/Concurrent Conditions: employee service,,,"['Body temperature', 'Cellulitis', 'Chills', 'Pyrexia', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",1,MODERNA,OT 1086029,IL,77.0,M,"UTI; Anemia; Colitis; A spontaneous report was received from a healthcare professional concerning a 77 years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed anemia, colitis and Urinary Tract Infection (UTI). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 039k208) on 29 Dec 2020. On 26 Jan 2021, approximately 6 days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 019K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 01 Feb 2021, the patient had a hospital visit for anemia and colitis for which patient was admitted and was discharged on 04 Feb 2021.The patient was again admitted to the hospital on 22 Feb 2021, for UTI and was at the hospital at the time of reporting. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events was not reported.; Reporter's Comments: Very limited information has been provided for this cases Although, a temporal association exist between the product use and the reported events of anemia and colitis, critical details such as the patient's medical history concomitant medication list lacking. Urinary tract infection is of an infective etiology as such a causal relationship is unlikely.",Not Reported,,Not Reported,Yes,,Not Reported,U,12/29/2020,02/01/2021,34.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Anaemia', 'Colitis', 'Urinary tract infection']",1,MODERNA,OT 1086030,GA,,M,"Broken nose; Rib fracture; Body ache; everything turned cloudy; A report from was received from a 66 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced everything turned cloudy, and his car crashed, suffered a broken nose, rib fracture and body ache. Patient's medical history and concomitant medications were not reported. On 24-Feb-2021 the patient received his second dose of mRNA-1273 (Lot number: 012L20A) injection intramuscularly in his left arm for prophylaxis of COVID-19 infection. On 25-Feb-2021, the patient crashed into a fire truck while driving. The patient ""totalled"" his Feb-2021, the patient was home with body aching everywhere The events broken nose and rib fracture and were medically significant. Action taken with mRNA-1273 was not applicable. Patient was treated with Ultram (tramadol hcl) 50mg and Skelaxin (metaxalone) 800 mg. Outcome for the event of body ache was not recovered/not resolved and for all other events the outcome was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/24/2021,02/25/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Depressed level of consciousness', 'Facial bones fracture', 'Pain', 'Rib fracture']",2,MODERNA,OT 1086031,FL,,F,"Hearing loss; Virus in ear; Arm was sore; A spontaneous report was received from a consumer, concerning a 73-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed arm sore, hearing loss and virus in my ear. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the events included losartan, fluticasone, escitalopram, esomeprazole sodium, simvastatin, cetirizine hydrochloride, alpha lipoic acid, chromium, cinnamon oil, ascorbic acid, folic acid, nicotinic acid, pyridoxine hydrochloride, retinol, riboflavin, vitamin b1 nos, vitamin b12 nos, vitamin d nos, vitamin e nos, turmeric [curcuma longa rhizome], vitamin B complex, vitamin D3, levothyroxine;liothyronine, fish oil, probiotics nos, ascorbic acid, melatonin, calcium, ubidecarenone, vitamin e nos, magnesium and polycarbophil calcium. On 29 Jan 2021, approximately 1 day prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. On 30 Jan 2021, the next day, after the first dose of vaccine, the patient woke up with arm sore which had lasted for two days. On 25 Feb 2021, the patient experienced hearing loss which was from a virus in her ear. Treatment for the events included high dose of prednisone tablets. Action taken with mRNA-1273 in response to the events were unknown. The event of arm sore was considered resolved on 01 Feb 2021. The outcome for the events of hearing loss and virus in my ear were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/30/2021,1.0,UNK,LOSARTAN; FLUTICASONE; ESCITALOPRAM; NEXIUM [ESOMEPRAZOLE SODIUM]; SIMVASTATIN; ZYRTEC ALLERGY; ALPHA LIPOIC ACID; CHROMIUM; CINNAMON OIL; MULTI VITAMIN [ASCORBIC ACID;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;V;,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Deafness', 'Ear infection viral', 'Pain in extremity']",1,MODERNA,OT 1086032,FL,,M,"cellulitis; A spontaneous report was received from a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed cellulitis. The patient's medical history was not reported. Concomitant medications were not reported. On an unspecified date, the patient received his first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. The patient reported that a few days after receiving the vaccine, he developed cellulitis. His physician prescribed antibiotics. Laboratory details were not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, cellulitis, was reported as resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Cellulitis'],1,MODERNA,OT 1086033,OH,67.0,F,"Blood clots in arm; Arm was sore; A spontaneous report was received from a healthcare professional concerning a 67-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm/pain in arm and blood clot in her arm/thrombosis. The patient's medical history, as provided by the reporter included diabetes. Concomitant medications were not included. On 15 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031M20A) in the left arm for prophylaxis of COVID-19 infection. On 15 Feb 2021, post vaccination the patient experienced sore arm and her condition got worse. She was then taken to emergency room with blood clots in her arm. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events, sore arm and blood clot in her arm, were not known.; Reporter's Comments: This case concerns a 67-year-old, female patient, who experienced thrombosis and pain in arm. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient's medical history of diabetes is a risk factor. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/15/2021,02/15/2021,0.0,UNK,,Diabetes,,,,"['Pain in extremity', 'Thrombosis']",1,MODERNA,OT 1086034,FL,,F,"Cough with phlegm; Covid pneumonia; tested positive for Covid 19; Loss of smell; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of smell,covid-19,covid pneumonia and cough with phlegm. The patient's medical history was not reported. Concomitant medications was not reported. On 03 Feb 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 09 Feb 2021,the patient experienced loss of smell.On 11 Feb 2021,she tested positive for covid pneumonia.On 16 Feb 2021,she had covid pneumonia.On 26 FEB 2021 she has cough with phlegm and slight loss of smell. This case is considered as a serious case as the event covid-19 pneumonia is medically significant. Lab details were not provided. Treatment for the events included Z pack,steroids and antibiotics. Action taken with mRNA-1273 in response to the events was not reported. At the time of the report,the events covid-19 pneumonia,anosmia,covid-19 and productive cough were unknown.; Reporter's Comments: Covid-19 pand Covid-19 pneumonia are unlikely to be related to Moderna Covid-19 vaccine. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/09/2021,6.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Anosmia', 'COVID-19', 'COVID-19 pneumonia', 'Productive cough']",1,MODERNA,OT 1086035,MN,,F,"Peripheral neuralgia; Left arm had numbness/belowboth knees to feet had numbness/Left hand fell asleep; Left arm had tingling /belowboth knees to feet had tingling; A spontaneous report was received from a consumer/patient concerning a 69-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed peripheral neuralgia, left arm had numbness/below both knees to feet had numbness/Left hand fell asleep, Left arm had tingling /below both knees to feet had tingling. The patient's medical history was not provided. At the time of the event the patient had allergy to narcotics and steroids, rheumatoid arthritis. No relevant concomitant medications were reported. On 01-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 006M2(or 0)0A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 01-Mar-2021, the patient had tingling and numbness on her left arm in the waiting area. Then the patient's left hand fell asleep. The patient reported, the same night it developed into peripheral neuralgia on both hands and then from below both knees to feet she had tingling and numbness. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events of developed peripheral neuralgia, left arm had numbness/below both knees to feet had numbness/Left hand fell asleep, Left arm had tingling /below both knees to feet had tingling was resolving The reporter did not provide an assessment for the events peripheral neuralgia, left arm had numbness/below both knees to feet had numbness/Left hand fell asleep, Left arm had tingling /below both knees to feet had tingling.; Reporter's Comments: Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/01/2021,03/01/2021,0.0,UNK,,Drug allergy (Allergy to narcotics and steroids),Medical History/Concurrent Conditions: Rheumatoid arthritis,,,"['Hypoaesthesia', 'Neuralgia', 'Paraesthesia']",1,MODERNA,OT 1086036,,74.0,M,"Got moderna vaccine first, mistakenly got the Pfizer Covid vaccine second.; There were only 12 days between the 2 doses.; A spontaneous report was received from a pharmacist concerning a 74-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) mistakenly took Pfizer-Biontech Covid-19 vaccine for second dose and only twelve days of time span between the two doses. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) for prophylaxis of COVID-19 infection. Twelve days after the vaccination (Inappropriate schedule of vaccine administered), the patient mistakenly took the Pfizer-Biontech Covid-19 vaccine for the second dose (Interchange of vaccine products). Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events was recovered for both events.; Reporter's Comments: This report refers to a case of interchange of vaccine products (Pfizer) for mRNA-1273, lot # unknown with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No adverse event history),,,"['Inappropriate schedule of product administration', 'Interchange of vaccine products']",1,MODERNA,OT 1086037,TX,,M,"Passed out for a few minutes; Nausea; 24 hours of fever; A spontaneous report was received from a consumer concerning a male patient of unspecified age, who received Moderna's COVID-19 Vaccine (mRNA-1273). The patient's medical history included immunodeficiency, cancer and gall bladder removal (not specified). Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on an unspecified date. On an unspecified date, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection. The patient had fever for twenty-four hours. On 26 Feb 2021, while on outing with patient's friend's patient had 2 beers. Later patient reported nausea and passed out for few minutes. However, patient drove back to home. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The event, fever was considered recovered/resolved on an unspecified date, and the events passing out and nausea were considered recovered/resolved on 26 Feb 2021.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,02/26/2021,,UNK,,Immunocompromised,Medical History/Concurrent Conditions: Cancer (NOS); Cholecystectomy,,,"['Body temperature', 'Loss of consciousness', 'Nausea', 'Pyrexia']",2,MODERNA, 1086038,AL,,F,"Drop on their sodium levels; A spontaneous report was received from a healthcare professional concerning, a 91-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported drop on sodium levels. The patient's medical history, as provided by the reporter, included bad fall the patient had a year ago. The concomitant medication included unspecified blood pressure and thyroid medications. On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. The patient was past due date for the second dose of the vaccine. On 28 Feb 2021, the patient experienced drop in sodium levels and was hospitalized. According to the patient's relative this could be attributed to the hitting of head due to bad fall the patient had a year ago leading to hospitalization. Since then the patient had been instructed to monitor sodium and potassium levels. Treatment information was unknown. Action taken with mRNA-1273 was unknown. The outcome of the event, drop on sodium levels, was unknown. The consumer assessed the event, drop on sodium levels/hyponatremia, as related to fall.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/20/2021,02/28/2021,39.0,UNK,,,Medical History/Concurrent Conditions: Fall (bad fall the patient had a year ago.),,,"['Blood sodium decreased', 'Hyponatraemia']",1,MODERNA,OT 1086040,IL,,M,"Breathing problems; Retaining a lot of fluids; A spontaneous report received from a Consumer, concerning 75-year-old male patient who received Moderna COVID-19 vaccine ((mRNA-1273) and experienced breathing problems and retaining a lot of fluids. The patient's medical history included breathing problem and retaining fluid. No relevant concomitant medications were reported. On 27-JAN-2021, the patient received his first of two planned doses of mRNA-1273 (Lot number: 038K20A) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection. On an unspecified date, the patient had experienced breathing problems and was retaining a lot of fluids. The patient was hospitalized on 24-JAN-2021. The patient was placed on a ventilator (defibrillator). The patient was discharged from the hospital on 28-JAN-2021. The patient stated that this had happened to him prior to getting the first dose of the vaccine. Action taken with mRNA-1273 in response to the event was not reported. Outcome of the events of having breathing problems and retaining a lot of fluids was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,01/27/2021,,,UNK,,Breathing difficult; Fluid retention,,,,"['Dyspnoea', 'Fluid retention']",1,MODERNA,OT 1086041,GA,71.0,F,"Very sensitive now to regular meds; lower back felt really heavy; pounding sensation up and down my torso; feeling of muscle heaviness that I almost felt paralyzed; extreme body ache; chills; I had a bad headache; stinging on both sides of my head and on hands and feet; was very lethargic; arm became real sore and was painful; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249, expiry date not reported), via an unspecified route of administration on the left arm on 27Jan2021 10:30 at single dose for covid-19 immunisation. Medical history included mild lupus, post concussion syndrome (PPCs) and allergies: sulfur (very sensitive to large doses) from an unknown date and unknown if ongoing. Concomitant medication included esomeprazole magnesium (NEXIUM), tramadol, alprazolam and acetylsalicylic acid (ALKA SELTZER). The patient reported that after just a few hours on 27Jan2021, their arm became real sore and was painful to use until next morning, was sore for 2 days. Hurt after much normal use. Woke up on the morning of 28Jan2021 (3 am) with chills, extreme body ache and feeling of muscle heaviness that they almost felt paralyzed. They could still move. They had a bad headache and stinging on both sides of their head and on hands and feet. They took aspirin and went back to sleep. When they got up they felt some better, but did not feel well and was very lethargic. That night they took another aspirin before bed. On the morning of 29Jan2021 (second day ) they again woke up at 3 AM to extreme body ache, the same heavy paralyzing feeling, but this time their lower back felt really heavy and there was a pounding sensation up and down their torso. They repeated the aspirin dose and went back to bed but did not sleep anymore that day. They did feel some better but still very lethargic. Next day better, but took 5 days to feel some normal w/o fatigue. The patient is very sensitive now to regular meds. Therapeutic measures were taken which included aspirin. The patient was recovering from feeling of muscle heaviness that I almost felt paralyzed, extreme body ache, chills, headache, stinging on both sides of my head and on hands and feet, lethargy recovered from arm became real sore and was painful on an unspecified date, while the outcome of the other events was unknown. The patient was not diagnosed with COVID prior to vaccination and has not been tested for COVID since vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,PUB,NEXIUM; TRAMADOL; ALPRAZOLAM; ALKA SELTZER,,Medical History/Concurrent Conditions: Drug allergy (very sensitive to large doses); Lupus erythematosus; Post concussion syndrome,,,"['Back pain', 'Chills', 'Drug hypersensitivity', 'Headache', 'Lethargy', 'Myalgia', 'Pain', 'Pain in extremity', 'Palpitations']",1,PFIZER\BIONTECH, 1086042,NC,74.0,M,"COVID-19; Fever; Pain; got sick; he did not feel well; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported 2 reports for herself and her husband. This is the 2nd of 2 reports and refers for her husband. A 74-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# unclear, E or FU4176), via an unspecified route of administration, on 28Jan2021, at single dose, for COVID-19 immunisation. Medical history included blood pressure high and non-alcoholic fatty liver. Concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on 05Feb2021 with outcome of unknown, fever (non-serious) on 05Feb2021 with outcome of unknown, pain (non-serious) on 05Feb2021 with outcome of unknown, got sick (non-serious) on 29Jan2021 with outcome of unknown, he did not feel well (non-serious) on 29Jan2021 with outcome of unknown. The patient got sick on the very next day and he did not feel well and each day he got worse and worse until his wife had to take him to the emergency room on 05Feb2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 05Feb2021. Therapeutic measures were taken as a result of the events and included treatment with Tylenol.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/29/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure high; Non-alcoholic fatty liver,,,"['COVID-19', 'Illness', 'Malaise', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1086043,TX,67.0,F,"all of a sudden it's 200 something 300 something and then the last couple days I'm battling 500 and something/the ingredients in the shot and it has sucrose; all of a sudden it's 200 something 300 something and then the last couple days I'm battling 500 and something/the ingredients in the shot and it has sucrose; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received her first dose of bnt162b2 (BNT162B2; lot number: EL3248; expiration date: unknown) at 67-year-old vaccination age at a single dose in the left arm for covid-19 immunization and sucrose at unknown dosing regimen for an unspecified indication, both via an unspecified route of administration on 30Jan2021. Medical history included diabetes. Concomitant medication included levothyroxine sodium (SYNTHROID) and insulin for diabetes. The patient reported that she received her first dose on 30Jan2021 with no problem at all but this past week her blood sugar levels have been climbing. She normally was 120-150 [unknown unit] then all of a sudden, it's 200 [unknown unit] something or 300 [unknown unit] something and then the last couple days (2021), she was battling 500 [unknown unit] and something. She was just wondered because she looked at the ingredients in the shot and it has sucrose, so she just wondered if that is why her sugar levels are rising. The patient has tried getting hold of her doctor to ask the same question, but her office is closed since last three days, so they didn't have their phones connected. She reported that she did not have issues with the shot, its fine didn't get sick or anything. She's just worrying if that's the reason her blood sugar levels are rising. The outcome of the events unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,,,UNK,SYNTHROID; INSULIN SUCROSE,,Medical History/Concurrent Conditions: Diabetes,,,"['Blood glucose increased', 'Reaction to excipient']",1,PFIZER\BIONTECH, 1086044,LA,77.0,F,"has not smell or taste a lot of the time; has not smell or taste a lot of the time; sight is not clear; flipped out; her blood pressure went up while she was in the Emergency room; panicked; Lightheadedness; Weakness; felt a little tired at that time; atrial fibrillation/started racing/Heartbeats irregular; anxiety; couldn't breathe/shortness of breath/hard time breathing; it was cold outside by her nephew's graveside, but she felt she had to fan herself like she was overheated; her heart rate was flying; scared; she said it was not a migraine headache like she is used to, but more of a mild headache; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EM9801), via an unspecified route of administration on the left arm, first dose on 04Feb2021 (Administered between 9:30-10:00AM) at single dose for COVID-19 immunisation. Medical history included chronic migraines all her life. She said her migraines have let up as she has gotten older. She also had an irregular heart rate before, saying her irregular heart rate started in her adult life. She said she considered herself more of a ""carrier"" for an irregular heart rate because her irregular heart rate doesn't happen enough for her to think about it. She said she doesn't have an irregular heart rate now. She said her father had a pacemaker & her 2 brothers had heart problems; her oldest brother passed away from his heart problems & her other brother has blood pressure issues. Patient also had mild asthma as an adult. She said she worked at (name) in a dusty environment, and lived near a landfill, where a lot of her neighbors have gotten sick. She said she needs an inhaler for her asthma. She said when she needs the inhaler, she takes 3-4 puffs at a time. She said she doesn't use the inhaler every day and also mentioned that her grandfather had died of a bad asthma attack. No previous immunization with the Pfizer vaccine considered as suspect. No vaccines administered on the same date of vaccine. No prior vaccinations within 4 weeks. There were no concomitant medications. On 13Feb2021, the patient experienced an atrial fibrillation in which she started racing and couldn't breathe. She mentioned that she recently attended a funeral but attributed the symptoms as side effects of the vaccine. She was taken to the Emergency room where she was given cortisone and resolved her symptoms. Patient also further reported she had side effects with the Pfizer COVID-19 Vaccine. She clarified she had her first COVID-19 Vaccine dose on 04Feb2021. She said her side effects happened less than 14 days after getting the COVID-19 Vaccine. Patient thought her side effects from the COVID-19 Vaccine may have been anxiety within. She said her nephew had died of COVID-19, and when she was at his funeral at the graveside, she flipped out while she was at her nephew's funeral, she was not doing good. She said she has a history of chronic migraines, and mild asthma. She said she had to lean against a gravestone because she couldn't breath. She said it was cold outside by her nephew's graveside, but she felt she had to fan herself like she was overheated. She said her heart rate was flying, and she had an irregular heart beat. She said she left her nephew's graveside and went to an urgent care. She said the doctor at the urgent care had done an EKG result abnormal, and told her she needed to go to the Emergency Room right away. She said the doctor had called the paramedics to transport her from the urgent care to the Emergency Room at (Institute name). She said she did not have any pain, but had a hard time breathing. She said she may have been scared because her grandfather had died of a bad asthma attack. She said she has chronic migraines, but what she had at the time was a mild headache, and not a migraine. She said she has not smell or taste a lot of the time. She clarified she has had no smell or taste for a while, saying she would not be able to tell if she got the COVID-19 Virus because of her loss of taste and smell. She said she was tested the Friday before her nephew's funeral and was negative for the COVID-19 Virus. She said she has had a total of four COVID-19 Virus tests before, and all her COVID-19 Virus tests have been negative. She clarified she did not have a COVID-19 Virus test while she was at the ER on Saturday, 13Feb2021. With her nephew's death, getting her COVID-19 Vaccine had left her mind. She said it didn't dawn on her until she settled down, and she thought her high heart rate and irregular heart beat were side effects of the COVID-19 Vaccine. She said she read the paperwork that was given to her at the time she got the COVID-19 Vaccine. She said the side effects listed for the COVID-19 Vaccine is what she had, a very fast heart beat, and it was very hard for her to breath. She said the Emergency Room doctor didn't think to ask her about the COVID-19 Vaccine. She said she panicked when she got to the hospital. She said she didn't even know that someone had drew blood from her. She said someone put a label on her, and told her the label was to show blood was drawn from her. She said when she looked down at the label, she saw an IV access was put in her arm. Additional treatment reported when she was in the Emergency Room, she was given an injection (clarified as IVPB on 13Feb2021) of Diltiazem 120mg at 12:13:50 PM, she said she was given another Diltiazem 5mg injection at the same time. She clarified she was diagnosed in the Emergency Room with Atrial Fibrillation. Patient stated that her blood pressure went up while she was in the Emergency room. She said she was kept in the Emergency Room so she could be monitored up until that evening. She said after the Diltiazem injections were given, her heart rate went down. She said the Emergency Room doctor gave her a prescription for Diltiazem 120mg white capsules, and told her to take the Diltiazem 120mg every day. She said the emergency room doctor told her she could go home, and that she needed to follow-up with her regular doctor. Reported she no longer has the shortness of breath, lightheadedness, or weakness. She said had felt a little tired at that time, as well. Patient also reported that on 22Feb2021 was her first day outside of her house since last Sunday (14Feb2021) and reported she has a slight headache, and her sight is not clear. She said she now feels she has ""name"" back, clarifying she has recovered completely. She has a follow up with her doctor on 24Feb2021. She is scheduled to take her 2nd dose on 04Mar2021 and is asking if she should take anything before the shot. Vaccination Facility Type was a pharmacy/drug store. Vaccine was not administered at Facility. The outcome of the events was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/13/2021,9.0,PHM,,,"Medical History/Concurrent Conditions: Asthma (mild asthma as an adult/needs an inhaler/grandfather died of asthma attack); Heart rate abnormal (adult life/father (pacemaker), brother (passed away from heart problems/blood pressure issues)); Migraine (had chronic migraines all her life/migraines have let up as she has gotten older)",,,"['Ageusia', 'Anosmia', 'Anxiety', 'Asthenia', 'Atrial fibrillation', 'Blood pressure increased', 'Blood pressure measurement', 'Dizziness', 'Dyspnoea', 'Electrocardiogram', 'Fatigue', 'Fear', 'Feeling abnormal', 'Feeling hot', 'Headache', 'Heart rate increased', 'Heart rate irregular', 'Panic reaction', 'SARS-CoV-2 test', 'Vision blurred']",1,PFIZER\BIONTECH, 1086045,,81.0,M,"tested positive for COVID; fever; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional. An 81-year-old male patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 20Feb2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Feb2021, the patient experienced fever, and was taken to hospital for a different issue and subsequently tested positive for COVID. The adverse event resulted in emergency room/department or urgent care and hospitalization. It was unknown if other vaccines received in four weeks. It was unknown that patient received treatment for adverse event. No covid prior vaccination. Covid was tested post vaccination in Feb2021. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/20/2021,02/20/2021,0.0,UNK,,,,,,"['Body temperature', 'COVID-19', 'Pyrexia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1086059,CO,92.0,F,"DVT in right leg discovered after swollen foot on 2/25/2021 via ultrasound. Clot extends from mid thigh to mid calf. Placed on Xarelto 15 mg 2x/day until next imaging appointment on March 30, 2021. First incident of blood clot for mother.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/21/2021,02/25/2021,4.0,OTH,"Claritan, Astrovastatin, Flecanide Acetate, Baby aspirin, Amlodipine Besylate, Martazapine, Tylenol","Urinary in continuance - on cathather for 3 years, supplemental oxygen","Insterstitial lung disease, high blood pressure, chronic bladder infections",,None,"['Deep vein thrombosis', 'Peripheral swelling', 'Ultrasound Doppler']",2,PFIZER\BIONTECH,SYR 1086076,CA,78.0,F,"Admitted to the hospital in observation status on 3/8/21 with chief complaint of ""I don't feel well, I feel dizzy and I had a rash."" Patient treated in urgent care on 2/24/21 for possible UTI and again in urgent care on 3/2/21 for cat bite and given ceftriaxone IM as well as Augmentin. Patient complains of feeling a little dizzy and not quite well, rash was fleeting but she has not been eating or drinking well since vaccination and has been having headaches since that time. She is afebrile and has no respiratory symptoms but positive covid-19 test (and antibodies). Patient did complain of nausea and dehydration. Discharged on 3/9/21.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/24/2021,03/09/2021,13.0,OTH,"ceftriaxone, Augmentin, atenolol, atorvastatin, amlodipine, amitriptyline, multivitamin, diclofenac topical",,"CDK Stage IV, migraines, osteoporosis, depression, hypertension, hyperlipidemia",,NKA,"['Blood creatinine increased', 'COVID-19', 'Dehydration', 'Dizziness', 'Headache', 'Hypophagia', 'Malaise', 'Nausea', 'Rash', 'SARS-CoV-2 test positive', 'White blood cell count normal']",1,PFIZER\BIONTECH,IM 1086077,IN,52.0,M,Chills and body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,None,None,None,,None,"['Chills', 'Pain']",1,JANSSEN,SYR 1086084,GA,58.0,F,"sensation of cold, circulation issues in extremities, Severe shakes, Chills, fever: 100.4 at highest, fatigue, muscle aches, abdominal pain. as of now, 15 hours later after incident started at 3:15 am, still low fever of 99.4 ad feel like crud, like have a flu.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,PHM,"Amlodipine 5 mg, 1x bedtime Tresiba, 18 units bedtime Omeprozole 20 mg, 1x day, pm Seroquel 50 mg, 1xday Ropinirole (for RLS) Up to 4mg Lithium 300 mg am 450 mg pm 750 a day total Levothyroixine 112mg, 1x day Atorvastatin 20 mg, 1",none,"Diabetes type 2, Bipolar, Thyroidectomy in 2002 so no thyroid",,"Keflex, Septra, Penicillin, Ampicillin, Codeine, Lactose Intolorent","['Abdominal pain', 'Chills', 'Fatigue', 'Feeling cold', 'Influenza like illness', 'Malaise', 'Myalgia', 'Peripheral vascular disorder', 'Pyrexia', 'Tremor']",UNK,JANSSEN, 1086095,IN,57.0,F,"Chills:started on day 1 lasted for 2 days low grade fever, started on day 2, last for 2 days 99.8-100.4 dull headache, 3 days, still a sympton breast/underarm tenderness, started on day 2 sour stomachs started on day 2, still a sympton",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,OTH,"Levothyroxine, Calcium, Vit. C, Vit. D3",None,None,,None,"['Breast pain', 'Chills', 'Dyspepsia', 'Headache', 'Limb discomfort', 'Pyrexia']",UNK,JANSSEN,IM 1086098,NJ,23.0,M,"10 min. after vaccine - small pang of soreness through left arm, went away after a couple of seconds 7:30 PM the same day - Grade 3 fever (102.9 degrees), intense chills, joint pain, minor headache, loss of taste and smell, coughing fits. Threw on lots of blankets, drank some water, and took two Tylenol pills. 10:30 PM the same day - while on Tylenol, fever dropped to 101.9. Kept taking Tylenol until I went to bed at around 1 AM. 9 AM on Sunday 3/7 - 101.2 w/out Tylenol, no chills or coughing, minor headache. Symptoms faded away over the course of the rest of the day. Back at 100% on Monday 3/8.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,None,None,None,,None,"['Ageusia', 'Anosmia', 'Arthralgia', 'Chills', 'Cough', 'Headache', 'Pain in extremity', 'Pyrexia']",UNK,JANSSEN,IM 1086111,IN,59.0,M,"Body ache, chills and headache and feeling hot",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/09/2021,2.0,OTH,"Metformin, Tamsulosin, Amlodipine, Pravastatin Sodium, Quinapril-Hctz, Men's One A Day vitamin and B12",None,"Diabetic , hypertension and cholesterol",,None that I'm aware of.,"['Chills', 'Feeling hot', 'Headache', 'Pain']",1,JANSSEN,SYR 1086112,IA,36.0,F,"Woke up with body aches and migraine. Migraine took me out all day. Serve lightheadedness, pass out (full on collapse, woke up laying on ground with hand twitching). Serve lightheadedness continued for next 5 days, where would become dizzy just sitting and if moved would need to stop and let body catch up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/03/2021,03/04/2021,1.0,PHM,colchicine 0.6 MG tablet enalapril 2.5 MG tablet sertraline 100 MG tablet cetirizine 10 MG tablet acyclovir 800 MG tablet,Recovering from Pericardial effusion which was caused from having covid,Recovering from Pericardial effusion which was caused from having covid,,,"['Dizziness', 'Loss of consciousness', 'Migraine', 'Muscle twitching', 'Pain']",UNK,JANSSEN,SYR 1086124,FL,37.0,F,Vaccine event: higher volume given. Approx 0.6 to 0.65 ml given to patient for Janssen vaccine instead of 0.5 ml. Currently no adverse consequences reported.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,,,UNKNOWN,,,"['Incorrect dose administered', 'No adverse event']",1,JANSSEN,IM 1086127,IN,59.0,F,"Around 1:30 am 3/6/21 I woke up nauseous. Did not vomit. When I got up around 8:30 am the nausea had eased up a lot. Later in the morning I started experiencing muscle aches in my neck, shoulders, back and arms along with a headache. Late afternoon I took my temperature and it was 100.6. I felt like crap! Went to bed around 9:00 pm still feeling bad Saturday night. I was much better when I woke up 9 hrs later.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/06/2021,1.0,UNK,"Duloxetine, Atorvastatin, Metoprolol, Meloxicam, Metformin, vitamin C, calcium, vitamin D",None,"Diabetes, hypothyroidism",,Sulpha,"['Headache', 'Myalgia', 'Nausea', 'Pyrexia']",UNK,JANSSEN, 1086133,MT,69.0,M,SIRVA,Not Reported,,Not Reported,Not Reported,,Yes,N,02/16/2021,02/16/2021,0.0,OTH,Eliquis and Lipitor,None,Afib,,None,['Shoulder injury related to vaccine administration'],1,PFIZER\BIONTECH,SYR 1086136,CA,49.0,F,Within 6 hours I had overwhelming headache with injection site pain that radiated up to my ear and down to my elbow. I had lymph node pain and swelling. The next 36 hours I felt general malaise with a bad headache which continued to linger throughout the week. A few days later on Feb 4 at 3am I woke up with extreme chest pain and trouble breathing. I was rushed to the hospital where I had an NSTEMI event resulting in a cardiac cath/thrombectomy removing a rope-like blood clot in an otherwise healthy heart.,Not Reported,,Yes,Yes,2.0,Not Reported,N,02/27/2021,02/28/2021,1.0,PVT,"zyrtec, flonase, Pepcid AC, tums, multi vitamin, calcium, antioxidant supplement, zinc, vitamin C, vitamin D, ""My Brain"" Feverfew & butterbur + Magnesium supplement by EU Natural , Goli Apple Cider Vinegar gummies","no illnesses, had recent physical that documented good baseline health with managed conditions","LCIS in breast, Sleep Apnea w/CPAP therapy, nerve pain in head/neck/pelvis, migraines, borderline hypertension controlled by diet & exercise,",,"penicillin, Vicodin, gluten,","['Acute myocardial infarction', 'Angiogram', 'Arthralgia', 'Catheterisation cardiac abnormal', 'Chest pain', 'Computerised tomogram', 'Dyspnoea', 'Ear pain', 'Electrocardiogram', 'Headache', 'Injection site pain', 'Laboratory test', 'Lymph node pain', 'Lymphadenopathy', 'Malaise', 'Pain', 'Thrombectomy', 'Ultrasound scan']",1,MODERNA,IM 1086138,SD,72.0,F,central vision loss confirmed with visual field test,Not Reported,,Not Reported,Not Reported,,Yes,N,01/27/2021,02/19/2021,23.0,UNK,"Citalopram, Levothyroxine, ropinirole, Omeprazole",,"chronic lymphocytic leukemia x 2016, thyroid dysfunction, GERD",,"codeine, latex","['Central vision loss', 'Visual field tests abnormal']",2,PFIZER\BIONTECH,IM 1086140,FL,67.0,F,Vaccine event: higher volume given. Approx 0.6 to 0.65 ml given for Janssen vaccine instead of 0.5 ml. No adverse consequences reported.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,,,,,,['Incorrect dose administered'],1,JANSSEN,IM 1086154,CA,18.0,M,"Janssen COVID-19 Vaccine EUA Awful headache, fever over 102, slow, weak, muscle aches, injection site hurts a lot.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,PHM,,,,,,"['Headache', 'Injection site pain', 'Mobility decreased', 'Myalgia', 'Pyrexia']",1,JANSSEN,SYR 1086155,FL,67.0,M,Vaccine event: higher volume given. Approx 0.6 to 0.65 ml given for Janssen vaccine instead of 0.5 ml. No adverse consequences reported.,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/08/2021,0.0,PHM,,,,,,"['Incorrect dose administered', 'No adverse event']",1,JANSSEN,IM 1086165,IA,16.0,F,"The patient is 16, and should have received the Pfizer shot, which is approved for 16 and up. The patient received a Janssen vaccine, which is only approved for 18 and up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,PHM,Unknown,Unknown,Unknown,,Unknown,['Product administered to patient of inappropriate age'],1,JANSSEN,SYR 1086176,IN,55.0,F,"Fever, chills, lower back pains and achiness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,OTH,"Simbrenza eye drops, blood pressure medication",None,Glaucoma,,None,"['Back pain', 'Chills', 'Pyrexia']",1,JANSSEN,SYR 1086187,NY,47.0,F,"Sore arm, fatigue, body aches (like recovering from flu), slight chills",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,SCH,Losartan,,Fibromyalgia,,,"['Chills', 'Fatigue', 'Pain', 'Pain in extremity']",1,JANSSEN,IM 1086197,TX,23.0,F,"At 10:44am, Fainting, drastic drop in blood pressure, blurred vision, numb hands. That evening, chills and vomiting.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,,,,,,"['Blood pressure decreased', 'Chills', 'Hypoaesthesia', 'Syncope', 'Vision blurred', 'Vomiting']",1,JANSSEN,SYR 1086198,,,U,"Fever up to 101.5, chills, fatigue, body aches and joint pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,,,,"['Arthralgia', 'Chills', 'Fatigue', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1086206,AZ,87.0,M,"Four days of feeling sick with aches, pains, upset stomach. On day 2 he was so sick he thought he would die. Sudden death on day 7.",Yes,02/25/2021,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/19/2021,1.0,PVT,unknown,no,nothing serious,,no,"['Abdominal discomfort', 'Malaise', 'Pain', 'Sudden death']",2,MODERNA, 1086209,NY,67.0,F,"lt foot is vibrating under skin, like a surge",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,UNK,"vitamin c,d",,,,,['Vibratory sense increased'],1,JANSSEN,IM 1086217,CA,62.0,F,"C/O feeling like her BP was high, had patient first drink water and lay down, then sent her to ED, they transferred her to hospital for admission.",Not Reported,,Not Reported,Yes,,Not Reported,U,03/06/2021,03/06/2021,0.0,OTH,"Patient has h/o HTN and takes an anithypertensive medication, did not state what it was at the time of the vaccination.",None noted except for her HTN,HTN,,"According to the enrollment questions, she had no allergies to medication, food, or other products",['Hypertension'],1,PFIZER\BIONTECH,IM 1086219,TX,28.0,F,"Patient fainted about 2 minutes after receiving vaccine. She experience nausea, dizziness , and a moment of confusion. Patient stated at pharmacy for 1 hour after episode. She was given water and crackers but refused other medical attention. Patient denied shortness of breath: difficulty breathing. Checked patients blood pressure. It was 144/74. Patient left pharmacy after 1 hour. She called when she make it home. She said she was still a little dizzy and nauseous. She had vomited. I asked patient if she was alone or if someone was there with her. She stated her sister is a nurse and was with her. Will follow up with patient on 3/10/21",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,PHM,,,,,,"['Confusional state', 'Dizziness', 'Immediate post-injection reaction', 'Nausea', 'Syncope', 'Vomiting']",1,JANSSEN,IM 1086222,,70.0,M,"Vaccine was not administered at our hospital, but reporting since patient presented to the ED. Presented to ED on 3/6/21 with right sided weakness. Admitted for acute right sided weakness. Unable to get MRI due to pacemaker. Discharged the next day in stable condition with clopidogrel and aspirin.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,03/01/2021,03/02/2021,1.0,PVT,"cetirizine (ZYRTEC) 10 mg tablet TAKE 1 TABLET(10 MG) BY MOUTH EVERY DAY ? cholecalciferol, vitamin D3, 2,000 unit Tab Take 2,000 Units by mouth every morning. ? lansoprazole (PREVACID) 30 mg capsule TAKE 1 CAPSULE BY MOUTH EVERY DAY ? mo",,BPH (benign prostatic hyperplasia) � ? GERD (gastroesophageal reflux disease) � ? Hypercholesteremia � ? Hypertension � � now off meds ? Kidney stone � � passed on own ? SSS (sick sinus syndrome) (HCC) � ? Thyroid nodule,,"Morphine, atorvastatin","['Cardiac assistance device user', 'Hemiparesis']",UNK,MODERNA, 1086228,CA,47.0,F,"5 min after shot became starting feeling unwell became faint had to lay down , was very hot, hearing was impaired , could not sit up for a few minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PHM,None,None,Migraines,,None,"['Dizziness', 'Feeling hot', 'Hypoacusis', 'Malaise']",1,JANSSEN,SYR 1086231,NY,71.0,F,"about two hours after injection, I experienced headache, then mild dizziness, then extreme dizziness, then sudden overwhelming fatigue, then swollen eyes and eyelids, then chills and elevated heart rate, with pounding. I had to cancel the class I was supposed to teach, because I would not have been safe to drive to campus. I slept from approximately 2:30 pm on March 8 until 8:30 am today, March 9, all symptoms continuing, with bathroom breaks, a couple of short reports to family members who were watching out for me, and one 2-hour window during which I ate a small meal, went back to bed, and read part of a book. During bathroom breaks I took more antronex, some milk thistle, and some glutathione, which seemed to at least temporarily reduce dizziness and eye/eyelid swelling. At one point I took some hawthorne tincture because I was concerned about the heart pounding. Today I woke up feeling symptom-free, but by 2 pm I was compelled by sudden fatigue to take a two-hour nap. After that I felt better, and I think I am now fine, at 7:45 pm on 3/9/21. I am happy to have gotten the Janssen vaccine, because it is one and done!",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,"antronex, L-glutathione",none,none,"smallpox vaccine in June 1966. I was 16.5 years old, approx. I have had NO VACCINATIONS SINCE. No flu shots, no tetanus boos","all petroleum derivatives, contrast dyes in medical procedures, volatile organic solvents, chlorine, scallops, some preservatives, formaldehyde, plastics and plastic outgassing, many insecticides, mildew and other molds","['Chills', 'Dizziness', 'Eye swelling', 'Fatigue', 'Headache', 'Heart rate increased', 'Palpitations', 'Swelling of eyelid']",UNK,JANSSEN,IM 1086248,MA,28.0,F,"3/6 3:30pm received vaccine. 6pm felt foggy, extreme exhaustion, irritable, nauseated, arm pain. Headache 3/7 12:30am restless in bed with muscle pain in thighs with burning sensation down into calves and up into lower back. 4:30am fever of 102 degrees Fever all day till about 8pm when temperature dropped below 100 degrees. Chills throughout day Extreme fatigue throughout day Headache 3/8 No fever in AM 8pm felt queasy & nauseated continued overnight. Extreme fatigue continued Slight cough Headache 3/9 Temperature over 100 Chills Queasiness and nausea continued throughout remainder of day. 6:30pm lesser sense of taste Headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,OTH,,,,,"Soma, fin fish, blue cheese","['Burning sensation', 'Chills', 'Fatigue', 'Feeling abnormal', 'Headache', 'Irritability', 'Myalgia', 'Nausea', 'Pain in extremity', 'Pyrexia', 'Restlessness', 'Taste disorder']",1,JANSSEN,SYR 1086250,UT,74.0,F,"The patient developed myalgia, fevers, chills within two days, she developed hypoxia. She also had a dry cough that developed sometime between her first and second dose of vaccine. On March 5th she was admitted to the hospital with oxygen saturation of 82 on room air. She improved and was discharged on the fourth day.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,03/02/2021,03/03/2021,1.0,PVT,"fosomax, vit c, ertapenem 1,000 mg daily (3 weeks in to 4 week course) for severe pansinusitis, fluticasone","Chronic pansinusitis. Infectious Disease had ordered invanz 1,000 mg daily IV for 28 days. She was about three weeks in to course.","Allergic rhinitis hyperlipidemia, IBS, osteoporosis, PTSD, Recurrent major depression, SVT",,"Clarithromycin, percocet","['Blood beta-D-glucan negative', 'C-reactive protein increased', 'Chills', 'Computerised tomogram thorax abnormal', 'Cough', 'Hypoxia', 'Lung opacity', 'Myalgia', 'Procalcitonin normal', 'Pyrexia', 'Respiratory viral panel', 'SARS-CoV-2 antibody test negative', 'SARS-CoV-2 test negative', 'Shift to the left', 'Staphylococcus test negative', 'White blood cell count increased']",2,MODERNA,IM 1086251,IN,34.0,F,"Fatigue/malaise, body aches, minor arm soreness bilaterally",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,PHM,"Prilosec OTC, Zyrtec OTC, Allegra OTC, prescription Amoxicillin 875 mg tablet since 3/7/21- duration 10 days total",Bilateral ear infection,Bilateral hearing impairment since birth,,None,"['Fatigue', 'Malaise', 'Pain', 'Pain in extremity']",1,JANSSEN,IM 1086256,,55.0,F,HR 81; BP 148/96; O2-96; pt experiencing some sweats but not in any distress,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/08/2021,0.0,OTH,,,,,,['Hyperhidrosis'],1,JANSSEN,IM 1086265,IN,50.0,F,"A hard painful knot developed at the injection site; surface of skin became pink. General malaise,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/08/2021,2.0,OTH,"Vitamin D3, Estroven, Multivitamin, fluticasone, fexofenadine hydrochloride.",None,"Obesity, allergies, knee osteoarthritis",,Allergy to pollen on black walnut tree.,"['Erythema', 'Injection site nodule', 'Injection site pain', 'Malaise']",UNK,JANSSEN,IM 1086277,IN,50.0,M,"Headache, severe body aches, tiredness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/06/2021,1.0,PVT,"Metformin, jardiance, centrum silver",sars 2 -11/28/2020 sick like sinus infection for a day or two,Type 2 diabetes,,None,"['Fatigue', 'Headache', 'Pain']",1,JANSSEN,SYR 1086293,MA,35.0,F,Uncontrollable shaking along with being bone chilling cold for approximately 2-3 hours; vomiting; severely itchy mouth and nostril (on left side); dizziness; intense cramps in thighs; minor headache,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PHM,,,,,,"['Chills', 'Dizziness', 'Feeling cold', 'Headache', 'Muscle spasms', 'Nasal pruritus', 'Oral pruritus', 'Tremor', 'Vomiting']",1,JANSSEN,SYR 1086306,CT,39.0,F,"Chills (severe for an hour) Fever (100.0), all day relieved briefly with tylenol Body aches, over 16 hours Dizziness, on and off Weakness, all day Headache, all day Arm pain around injection site",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,UNK,"Atenolol, levothyroxine, zyrtec, pre-natal vitamins, magnesium.",None,"Seasonal allergies, exercise induced asthma, neurocardiogenic reflex with syncope.",,None,"['Asthenia', 'Chills', 'Dizziness', 'Headache', 'Injection site pain', 'Pyrexia']",UNK,JANSSEN,IM 1086309,NV,31.0,F,Patient fainted about 5 minutes after receiving the vaccine. She was in the monitoring area and fell over and hit her head on the ground. I went to her aid and monitored her until the paramedics showed up. She was unconscious for a 10-15 seconds with her eyes open before regaining consciousness. IShe was not having breathing problems or other symptoms of anaphylaxis so i did not administer an epi-pen or benadryl to her. I rolled her on her side in case she became nauseas. Then the paramedics arrived and attended to her.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,PHM,,,,,,"['Fall', 'Head injury', 'Loss of consciousness', 'Syncope']",1,JANSSEN,IM 1086316,PA,62.0,F,"Patient stated after about 15 minutes after receiving vaccine that her face felt numb, she said it feels like it spread from her arm where the shot was given up into her neck and into her face which was numb and tingly",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,PHM,NONE REPORTED,NONE REPORTED,"MIGRAINES, ALLERGIES",Patient stated she previously had a reaction to shingles vaccine received. Also when she got infusions of antibiotics in the hos,"PENICILLIN, VANCOMYCIN, ROCEPHIN","['Hypoaesthesia', 'Paraesthesia']",1,JANSSEN,IM 1086317,NY,47.0,M,"Got vaccine at 12:30am, was home asleep by 2:30. Head was insanely stuffy when I woke up around 8:30, my ears hurt on the inside and I couldn?t hear well. My lungs felt kind of funny, as if I?d taken too much asthma medication. By noon my lungs were burning with every breath, my eyes were hot and weepy, the fever and muscle/joint aches had gotten really bad, and I had pain in my neck under my jaw between chin and ears.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,PUB,"Thiamin, vit D, lithium, fluoxetine, pantoprazole, amlodipine, losartan, metformin, albuterol,",None,"GERDS, obstructive sleep apnea, mental health, hypertension, diabetes 2, exercise induced asthma",,Cipro,"['Arthralgia', 'Burning sensation', 'Ear pain', 'Eye irritation', 'Feeling abnormal', 'Hypoacusis', 'Lacrimation increased', 'Myalgia', 'Nasal congestion', 'Neck pain', 'Pain in jaw', 'Pyrexia']",1,JANSSEN,IM 1086323,IN,58.0,M,"fever over 102, chills and shakes. chills went away around 4:00 am, fever was gone when I woke up....Slight headache during the day Saturday, headache was gone on Sunday when I woke up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,atorvastatin,none,none,,none,"['Chills', 'Headache', 'Pyrexia', 'Tremor']",1,JANSSEN,IM 1086324,MO,59.0,F,"pt states she had unusual taste sensation at time of injection. She then felt a ""weird feeling"" in her chest area. She desribed it as a pressure (not pain or inflammation). We discussed treatments of ADR. We opted to have her wait longer. She stayed 37 min. During that time the pressure sensation moved lower in chest area and reduced in sensation. She was feeling comfortable at that time and left pharmacy area. RPh followed up 3/9 734 pm and she was doing well.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PHM,"rhinocort, sudafed 12hr. omega 3, vit d, calcium + d , lysine, zinc , probiotic , allegra",carpal tunnel,hypoglycemia,,none,"['Chest discomfort', 'Taste disorder']",1,JANSSEN,IM 1086333,NJ,22.0,M,Patient fainted after receiving vaccine. Regained consciousness shortly after and began throwing up,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,PHM,"Sertraline, methylphenidate",,"Anxiety, ADHD",,NKDA,"['Loss of consciousness', 'Syncope', 'Vomiting']",1,JANSSEN,IM 1086336,OH,51.0,F,"I had dizziness for the majority of the day Saturday and Sunday. I was fatigued, but made myself stay awake up the whole day Saturday. I had a very weird dream Saturday night and woke up very tired Sunday morning around 8 am. I went back to bed 11:15 am and slept until 1:30. The dizziness lasted the rest of Sunday. I have only slept for 5 hours between Sunday night and today (Tuesday March 9th).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/06/2021,1.0,PHM,"Vitamin D3 2,000 IU; Vitamin C 500 mg; Zinc 50 mg; Citalopram HBR 10 mg",none,none,,none,"['Abnormal dreams', 'Dizziness', 'Fatigue', 'Sleep disorder']",1,JANSSEN,IM 1086346,KS,26.0,F,"Cluster headache behind right eye that turned into eye pain around/behind eye (not the eye itself) Headache subsided with ibuprofen and Tylenol but pain around/behind eye persisted (currently on day 4, discomfort has subsided some but still noticeable)",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,UNK,Fluoxetine 20 mg Cryselle Zyrtec 10 mg Famotidine 10 mg,None,Seasonal allergies,,None,"['Cluster headache', 'Eye pain']",UNK,JANSSEN,SYR 1086350,OH,38.0,F,Vaginal spotting began two days after with increased volume each day (no reason for spotting and have never spotted). Neck pain started on day three. Took ibuprofen to reduce pain. Pain returned after medication wore off.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/08/2021,2.0,PUB,Zyrtec,None,None,,None known,"['Neck pain', 'Vaginal haemorrhage']",1,JANSSEN,SYR 1086351,VA,88.0,M,"-Rapid onset shortness of breath (10-20 minutes after vaccine administration). -Required ICU admission for acute respiratory failure and acute heart failure. -Acute reduction in ejection fraction (EF20-25%) in a patient that otherwise had a normally documented EF (>65%), see below. -Hospital course required BiPAP and dobutamine support and treatment for pulmonary edema with Lasix. -Cardiology consulted for acute heart failure management. Eventual wean of oxygen and dobutamine requirement and discharged on oral heart failure regimen. -Hospital course complicated by ICU delirium. -Total length of hospital stay 8 days",Not Reported,,Yes,Yes,8.0,Not Reported,Y,02/26/2021,02/26/2021,0.0,PHM,,,,,,"['Acute respiratory failure', 'Akinesia', 'Bilevel positive airway pressure', 'Cardiac failure acute', 'Cardiac stress test abnormal', 'Delirium', 'Dyskinesia', 'Dyspnoea', 'Echocardiogram abnormal', 'Ejection fraction decreased', 'Infarction', 'Intensive care', 'Left ventricular dilatation', 'Mitral valve incompetence', 'Pulmonary oedema', 'SARS-CoV-2 test negative', 'Ventricular hypokinesia']",2,MODERNA,SYR 1086357,IN,57.0,F,"Arm/shoulder pain, chills, low-grade fever (100.2) from approximately 3:30 a.m. - 3:30 p.m.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/06/2021,1.0,OTH,"Levothyroxine, pravastatin, acetazolamide, aspirin",None,"Low thyroid, Menieres disease","Shingrix shingle vaccination - 2 doses, right upper arm. Fever, chills, nausea, headache, fatigue, arm pain. Vaccination dates -",None,"['Arthralgia', 'Chills', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,IM 1086358,NY,37.0,F,"Janssen COVID-19 Vaccine EUA High fever started 9 hours after vaccination, continued until 24 hours after vaccination. Nausea and dizziness started 9 hours after vaccination, continued until 12 hours after vaccination. 5 weeks pregnant- spotting started 25 hours after vaccination. No proven correlation between potential miscarriage and Vaccine. Generalized, spotty red rash, slightly raised, no itch, on the front torso, from top of legs, groin area, up to shoulders, on front torso only (not on arms or back) 33 hrs after vaccination.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,SCH,Pre-natal vitamins L Theanine CoQ10 Fish Oil,None,None,,Allergic to Lipstick and scented hair products,"['Dizziness', 'Nausea', 'Pyrexia', 'Rash', 'Rash erythematous', 'Rash papular', 'Vaginal haemorrhage']",1,JANSSEN, 1086359,MA,74.0,F,"about 15 hours after shot developed fever (99.5) and chills and headache. This laster about a day. Then I felt like I had a cold and had ntermittent slight sore throat. On the third day after shot experienced mild nausea. Headache disappeared as did sore throat. At no time was there soreness at injection site, and I had no arm pain at all. So in toto, I was out of commission for 3 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/06/2021,1.0,PVT,"Tapazole (.5mg 2x week), multivitamin, calcium, vit.D3, biotin, cetrizine",Kidney stone 12/31/2020,"Graves disease, medullary sponge kidneys, stones",,sulfa,"['Chills', 'Headache', 'Nausea', 'Oropharyngeal pain', 'Pyrexia']",UNK,JANSSEN,IM 1086360,IN,58.0,F,"Spiked a temperature of 102 degrees 4 hours after getting the shot. Had severe chills where my body was shaking. Next day was down to 99.7 but had to stay on the couch all day due to body aches, head ache, etc. On Monday (Got the shot on that Saturday) I felt like myself around 10am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,OTH,,None,None,,"Penicillan, Ceclor, Keflex","['Chills', 'Headache', 'Pain', 'Pyrexia', 'Tremor']",UNK,JANSSEN, 1086361,TX,24.0,F,"Patient came in for Janssen COVID vaccine that was scheduled electronically online. All appropriate prescreening was done and patient had no previous allergies or issues. Patient was instructed to sit in one of the chairs designated for post vaccine observation for 15 minutes after her vaccine. Within a minute or so patient felt light headed and like she might pass out. She notified the technician who was right there and he notified me. I assisted her to a sitting position on the floor from her chair and I was able to ease her back to a lying down position from there with her head on the floor and feet elevated above heart on a chair. Patient was able to talk the whole time. She told us at that point when she was younger she was scared of shots and had fainted when having them, but thought she was past that and did not mention it during screening. She said she was surprised to feel this way because she was so excited about getting her COVID vaccine. She had not eaten much today (a small snack) and had rushed here for her appointment without getting food. I checked her blood pressure while she was lying down and it was 94/63 and pulse of 75. She said she normally had lower end of normal blood pressure. She was pale when I started checking her, but her color began to return to normal within minutes. After 5 minutes she felt well enough to sit up and we got her a granola bar and water. She remained this way for 5 minutes and felt good, so we moved her to sitting in a chair and got her a pepperoni and cheese snack tray from the cafe. She ate this and waited for 10minutes and felt good. We walked her to her car and she felt fine. I called to verify she got home fine and she did.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PHM,None known,None,None,She has fainted before and has a fear of needles.,None,"['Asthenia', 'Dizziness', 'Pallor']",1,JANSSEN,IM 1086366,NJ,52.0,F,"Itchy rash, red bumps in and around injection site. Injection site soreness four days later. Hard callously feeling around injection site on left arm where vaccine was given.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/07/2021,2.0,OTH,"B12 vitamin, Biotin, Multivitamin with a Probiotic",None,None,,Demerol,"['Injection site induration', 'Injection site pain', 'Injection site pruritus', 'Injection site rash']",1,JANSSEN,SYR 1086367,WA,58.0,M,Guillian Barre Syndrome,Not Reported,,Not Reported,Yes,,Yes,N,02/08/2021,02/13/2021,5.0,PVT,,None,,,,"['CSF protein increased', 'CSF white blood cell count', 'Guillain-Barre syndrome', 'Lumbar puncture abnormal']",UNK,PFIZER\BIONTECH, 1086369,TX,37.0,M,"Patient came in for Janssen COVID vaccine that was scheduled electronically online. All appropriate prescreening was done and patient had no previous allergies or issues. Patient was instructed to sit in one of the chairs designated for post vaccine observation. Within minutes (less than 3), patient was very dizzy, clammy (cold sweats), pale and said he did not feel right. I assisted him to a sitting position on the floor from his chair and we were able to ease him back to a lying down position from there with his head on the floor and feet elevated above heart on a chair. Patient said that the cold floor actually made him feel better instantly. At 4:18pm after lying down for about 3 minutes we checked his blood pressure with him still lying down. It was 110/88 and pulse of 104 (so slightly elevated pulse). He said he was feeling better and we kept him lying down. Patient's wife was also there so she was able to provide information in addition to him doing it also. She did state that he occasionally had panic attacks and she thought this might be one, the patient was adamant that it was not. At 4:24 pm we checked his blood pressure again and it was 100/90 and Pulse of 104. He was feeling quite a bit better so we had him come to a sitting position on the floor and he had not eaten in a while so we got him a granola bar and water. Pt slowly ate these and begin to feel clammy and sweaty again within 3-4 minutes. We checked his blood pressure again and it was 104/90 and pulse of 100. He wanted to stay sitting to see if it would pass. We did continuously observe injection site and screen for any other symptoms of an allergic reaction (nausea, cramping, swelling, and none of these were occurring). Since he was still not feeling well we gave the patient 50mg of benadryl (20 mls of 12.5mg/5ml liquid benadryl) with his approval. After about 10 minutes of sitting total he was still having cold sweats and feeling dizzy so we had him lie back on his back with his feet elevated while the benadryl kicked in. By 4:50pm he was feeling well enough to sit back up and we got him some wraps and a coke from the cafe to eat. Pt continued to consistently improve and was ready to leave about 5:20pm. We advised him and his wife of signs and symptoms of allergic reaction and to have those treated to immediately at urgent care or and ER. We also told him to follow-up with his PCP. I had a manager help walk them to their car. They were very kind and grateful. I will follow-up with a call tomorrow and again on Friday to make sure he continues to do well.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/09/2021,03/09/2021,0.0,UNK,,,,,,"['Cold sweat', 'Dizziness', 'Feeling abnormal', 'Heart rate increased', 'Hyperhidrosis', 'Immediate post-injection reaction', 'Pallor']",1,JANSSEN,IM 1086373,IN,51.0,M,"Chills, aches and pains - lasted approximately 12 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,"Tadalifil, citalopram, aspirin, lisinopril, albuterol, pravastatin,",None,"Asthma, HBP",,None,"['Chills', 'Pain']",UNK,JANSSEN,SYR 1086380,NC,24.0,M,"Quick onset of fever (peaked at slight above 100 deg F), chest pains, shortness of breath, and severe chills about 11 hours after vaccine was taken. These symptoms were mild the next morning and afternoon and I was able to work fine from home. This evening, my fever once again flared up to 100 deg F.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,SCH,None,None,None,,None,"['Chest pain', 'Chills', 'Dyspnoea', 'Pyrexia']",1,JANSSEN,SYR 1086405,TX,35.0,M,"Pt was on his 15 minutes observation period after the covid-19 vaccine. About 10 minutes after receiving the vaccine, he said he had pins and needle feeling on his left arm from his elbow to his ring and pinky fingers. He also had a ""warm feeling"" at the same area. We recommended him staying longer for observation. After about 10-15 minutes he wanted to leave. He now describe it similar to ""numbness on your foot when you sit on it too long"". He said he would be okay and he left.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,PHM,,,,,,"['Feeling hot', 'Paraesthesia']",UNK,JANSSEN,IM 1086417,IN,51.0,F,"Fatigue, muscle aches, headache, nausea and continuing pain in right jaw joint",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,OTH,"Sprintec, zantac, zyrtec-d, vitamin c, cinnamon, restasis, calcium with rosehips and levothyroxine",None,"Hypothyroidism, seasonal allergies",,Sulfa,"['Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pain in jaw']",1,JANSSEN,SYR 1086421,TX,38.0,M,"No symptoms within first 2 hours of vaccination. At about 2 hours, became extremely sensitive to light and sound, severe headache/migraine (pain 7/10) to left side, and heavily fatigued. No discomfort at injection site. Temp 99.1�F, muscle pain, weakness, stiffness approx 5 hrs after injection. OTC Tylenol (700mg) taken around 7 hrs after injection with no relief of symptoms. Unable to stay awake, slept approx 12 hours from 21:30 on 03/08/2021 until 09:30 on morning of 03/09/2021. All symptoms still active, headache improved slightly (5/10) but muscle stiffness, muscle pain, and fatigue worse. Nausea and mild abdominal pain/cramping around noon. Fever of 101.2�F at 13:00 on 03/09/2021, 100.0�F at 16:00, and down to 99.1 at 20:00.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/08/2021,03/08/2021,0.0,UNK,,,,,,"['Abdominal pain', 'Fatigue', 'Headache', 'Hyperacusis', 'Migraine', 'Musculoskeletal stiffness', 'Myalgia', 'Nausea', 'Photophobia', 'Pyrexia']",1,JANSSEN,IM 1086428,,58.0,F,"start to have fever, chill, and body ache after 8 hours later (99-102) , last for 36 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,UNK,,,,,,"['Chills', 'Pain', 'Pyrexia']",1,JANSSEN, 1086429,CA,73.0,F,"Patient developed left sided pleuritic chest pain and dyspnea on 3/8 in the evening. She presented to the ED 3/9 and was found to have a segmental left lower lobe pulmonary embolism (left lateral basilar segment) with associated LLL pulmonary infarction. She had tachycardia to low 110s, mild hypoxia to 89% on room air with no evidence of pneumonia or typical COVID infiltrates. She had no known COVID exposure. She had one prior pulmonary embolism in 1999 treated for 6 months with coumadin, and was subsequently found in 2000 to be heterozygous for Factor V Leiden. She is being admitted to the hospital for treatment of pulmonary embolism.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,03/05/2021,03/08/2021,3.0,OTH,Atenolol 50mg once daily Pravachol 40mg once daily,No acute illnesses,"Factor V Leiden heterozygosity with history of Pulmonary embolism in 1999 HTN CKD stage 2, baseline cr 0.9-1.0 Dyslipidemia Osteoporosis",,codeine norco tetracycline,"['Angiogram pulmonary abnormal', 'Blood pH normal', 'Brain natriuretic peptide normal', 'Chest X-ray', 'Dyspnoea', 'Fibrin D dimer increased', 'Full blood count normal', 'Hypoxia', 'Influenza virus test negative', 'Laboratory test normal', 'Pleuritic pain', 'Pulmonary embolism', 'Pulmonary infarction', 'Respiratory syncytial virus test negative', 'SARS-CoV-2 test negative', 'Tachycardia', 'Troponin normal']",1,PFIZER\BIONTECH,IM 1086433,IN,51.0,M,"Fever, chills, headache, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,UNK,None,None,None,,None,"['Chills', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1086434,NJ,26.0,F,"Significant body aches and pain all over body, fatigue, headache, injection site pain the night after getting the vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,PHM,"Lexapro, Adderall, probiotic, vitamin, birth control, Allegra, Airborne",None,None,,None,"['Fatigue', 'Headache', 'Injection site pain', 'Pain']",UNK,JANSSEN,SYR 1086439,MA,84.0,M,"Severe weakness 3 days after vaccine (3/5), to the point I which patient could not stand. Presented to hospital 6 days after vaccine (3/8). Hospital workup notable for CPK 45,720 U/L with CRP 109 (3/8) and low-grade fever (3/9). Negative infectious workup so far (BCx, Biofire, COVID PCR, UA without WBCs, no leukocytosis). He also had new thrombocytopenia to 84 (3/8), but possibly due to rifampin for LTBI. He remains admitted at this time, receiving fluids for rhabdo, undergoing further infectious and rheumatologic workup.",Not Reported,,Not Reported,Yes,,Not Reported,N,03/02/2021,03/05/2021,3.0,PVT,Rifampin,,"Latent TB infection (several weeks into rifampin), hypertension",,,"['Asthenia', 'Blood creatine phosphokinase increased', 'Blood culture negative', 'C-reactive protein increased', 'Dysstasia', 'Platelet count decreased', 'Pyrexia', 'SARS-CoV-2 test negative', 'Thrombocytopenia', 'Urine analysis normal', 'White blood cell count normal']",2,PFIZER\BIONTECH,IM 1086443,UT,27.0,F,"I'm not sure if the Janssen is the same as Johnson and Johnson? But I'm type 1 diabetic and my blood sugars have been at dangerously high levels for 3-4 days now. They still haven't gone down. I've been taking two times as much long acting insulin as I usually take, tripling the amount of fast acting insulin I usually take, and am only eating protein and vegetables (no carbs) to try to keep my sugars in normal range, and even then they are stubbornly sticking around 250 to 400. I want doctors and patients to be aware of this side effect because it was really scary for me and it still hasn't resolved itself.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/07/2021,2.0,UNK,Insulin,None,Type 1 Diabetes,,None,['Blood glucose increased'],UNK,JANSSEN, 1086445,CO,18.0,F,"Severe headache , chills, fever, sweating, whole body aching. Nausea vomiting and stomach pain",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PHM,None,,Asthma,,"Allergic to hazelnut, peanuts","['Abdominal pain upper', 'Chills', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pain', 'Pyrexia', 'Vomiting']",1,JANSSEN,SYR 1086449,AZ,42.0,F,"72 hours fever, and headache migraine 3 days, injection spot swelled three times normal...inch above normal skin, 3 weeks mono like sleepinnes, cough for two weeks, ab pain day 6 for three day",Not Reported,,Not Reported,Not Reported,,Yes,U,01/06/2021,01/06/2021,0.0,PVT,"Magnesium, vit k, calcium, women daily vitamin,",,Narcolepsy,,,"['Abdominal pain', 'Cough', 'Injection site swelling', 'Migraine', 'Pyrexia', 'Somnolence']",1,MODERNA, 1086457,LA,27.0,M,Fever. 102.9. Chills. Nauseous. Vomited.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,OTH,,None,None,,Ceclor,"['Chills', 'Nausea', 'Pyrexia', 'Vomiting']",1,JANSSEN, 1086474,IN,59.0,F,swollen / puffiness on left collarbone neck area. still swollen / puffy,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,OTH,Levothyroxine 50 MCG (took at 7:30am),,,shingles shot - chills after second shot,,['Lymphadenopathy'],1,JANSSEN,SYR 1086478,NH,65.0,F,TIA followed by mild stroke 10 hours later. Hospitalized for 2 days for tests and observation.,Not Reported,,Not Reported,Yes,2.0,Yes,N,03/03/2021,03/05/2021,2.0,PUB,Lamictal 300 mg Zoloft 100 mg Pantoprazole Sodium 40 mg Simvastatin 40 mg Lorazepam 1 mg Lisinopril 10 mg,Sinusitis,Bipolar Depression High Cholesterol High Blood Pressure Acid Reflux Insomnia,,Septra,"['Blood test abnormal', 'Cerebrovascular accident', 'Computerised tomogram head abnormal', 'Magnetic resonance imaging head abnormal', 'Thalamic infarction', 'Transient ischaemic attack']",1,PFIZER\BIONTECH,SYR 1086485,IA,31.0,F,"chills, aches, nausea, high fever:103.9 and rising.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,WRK,None,None,None,,Unknown,"['Chills', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1086490,WA,88.0,U,"Ground level fall 3/5, injured arm. Was seen in ED, discharged. ED visit next 3/7 dizziness, fell hit shoulder, dislocated. Patient could not walk, had difficulty swallowing. Admitted for observation.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/09/2021,03/05/2021,24.0,PVT,,,,,,"['Dizziness', 'Dysphagia', 'Fall', 'Gait inability', 'Joint dislocation', 'Limb injury']",1,PFIZER\BIONTECH, 1086493,HI,51.0,M,"The night after receiving the second dose of the Pfizer Covid , the patient developed severe headache, who body myalgias, severe fatigue, and fevers. The next day he also developed pleuritic chest pain and shortness of breath. He described the chest pain as like a heart burning sensation, worse lying down and better sitting up. He documented a fever to 100.8 deg F. By the thord day the fever had resolved but the chest pain persisted, leading him to present to the emergency department. On exam he had BP 113/84, HR 95, RR 18, O2Sat 95% on RA, Temp 97.5 F. His lungs were clear to auscultation. Heart was RRR, S1, S2 WNL without MGR. ABD was soft, without tenderness, masses or HSM.",Not Reported,,Not Reported,Yes,3.0,Yes,N,03/02/2021,03/03/2021,1.0,MIL,"docusate, sildenafil, ketoconazole shampoo, working out supplement containing taurine, theobromine, amino acids, and other components.",None,Hyperlipidemia Traumatic spinal cord injury with paraplegia at T12 s/p skiing accident and spinal fracture 8 years previously. sleep apnea,,None,"['Alanine aminotransferase normal', 'Aspartate aminotransferase increased', 'Blood cholesterol increased', 'Blood triglycerides normal', 'Brain natriuretic peptide increased', 'C-reactive protein increased', 'Chest pain', 'Computerised tomogram thorax normal', 'Dyspnoea', 'Echocardiogram abnormal', 'Ejection fraction decreased', 'Electrocardiogram PR segment depression', 'Electrocardiogram ST segment elevation', 'Fatigue', 'Headache', 'High density lipoprotein normal', 'Low density lipoprotein increased', 'Mitral valve incompetence', 'Myalgia', 'Pleuritic pain', 'Pyrexia', 'Tricuspid valve incompetence', 'Troponin increased', 'Ventricular hypokinesia', 'White blood cell count increased']",2,PFIZER\BIONTECH, 1086497,IN,58.0,F,"At 5:00pm, March 5th (7.5 hours after the jab) I suddenly got cold chills, nausea, and terrible headache. I eventually threw up. I hade joint aches and I couldn?t seem to get warm. At 1:00am, March 6th after taking aspirin as directed on the label, my headache subsided and I felt famished and I felt like a new person.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,"The morning of my vaccine I took my meds: Sertraline 150 mg, Rosuvastatin Calcium 10 mg, Olmesartan Medoxomil Amlodipine and Hydrochlorothiazide 20 mg, 5mg, 12.5 mg.",None,"High blood pressure, high cholesterol, anxiety. Medicated for all three",,None,"['Arthralgia', 'Chills', 'Feeling cold', 'Headache', 'Hunger', 'Nausea', 'Vomiting']",UNK,JANSSEN,IM 1086503,TX,30.0,F,Hardened and swollen 2inches at injection sight lasting more than 3 days + sore to touch,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PVT,Lexapro Gabapentin,None,None,,None,"['Injection site induration', 'Injection site pain', 'Injection site swelling']",1,JANSSEN,SYR 1086505,IL,45.0,M,Fever and chills started all of the sudden around 5:15 pm on day of vaccination (3/8). Fever and chills have continued through say and evening of 3/9.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/08/2021,03/08/2021,0.0,PUB,None,None,Overweight,,None,"['Chills', 'Pyrexia']",1,JANSSEN,IM 1086506,IN,57.0,M,"March 8th Body ache, tired, congestion, chills. I Left work at 5pm, went to bed at 6pm, Took ibuprofen PM. Slept until 10:30pm, had some water, went back to bed. Woke up at 4:30am (March 9th), wet from sweat/fever, difficulty breathing through nose. Took two more ibuprofen PM. Slept until 11:30 am. Felt better, but stayed home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,meloxicam,None,Back pain,I have been sick previously after some regular Flu shots.,None,"['Chills', 'Fatigue', 'Hyperhidrosis', 'Nasal congestion', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1086511,MD,29.0,M,"vasovagal syncope or seizure? After receiving the drive-through vaccine, we drove into a parking space to sit and make sure I was ok. Within 5-10 minutes, I was sitting in the car and sending a text and with no warning whatsoever mid-text lost consciousness, profuse sweating, wheezing, lost color in my skin, was making unintelligible noises, and eventually woke up about a minute later but couldn't speak or comprehend those speaking to me (according to my wife who was terrified). I was not nervous, stressed, or scared of receiving a vaccine. I regained the ability to speak about a minute later and my wife had summoned the staff on the scene who instructed me to lie back and breathe without a mask. I drank some liquids. A nurse was called over and offered to take my vital signs but I decided I felt ok enough not to. Eventually my normal skin color and came back and sweating stopped after about 5 minutes. We sat for a few extra minutes and once I felt it was past me, my wife drove us home.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PUB,,none,,,none,"['Aphasia', 'Hyperhidrosis', 'Loss of consciousness', 'Pallor', 'Transient aphasia', 'Wheezing']",1,JANSSEN,IM 1086512,NY,35.0,F,Patient received Janssen vaccine after denying having a previous COVID-19 vaccine. She then showed her other card which indicated she had Moderna 031L2DA on 1/31/21 but she had allergic reaction of hives. She came on 3/7/21 to Facility and was turned away for already having reaction to previous vaccine. She states she was cleared by allergist and returned on3/9/21 for the Janssen vaccine and showed up with her 3/7/21 ticket. Unfortunately it was not caught in time and she was vaccinated with COVID. She is being observed for over an hour.,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/09/2021,03/09/2021,0.0,OTH,unknown,unknown,unknown,Moderna vaccine. had hives.,unknown,['Interchange of vaccine products'],1,JANSSEN,IM 1086519,IN,59.0,F,"I had Covid in January. I felt fine after 12::30vaccine then awoke at 4:30an .. chills, earache, hot neck, extreme tiredness... body aches.. lasted until 6:00pm that day",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/07/2021,1.0,PUB,None,None.. but had Covid in January,,,Latex,"['Chills', 'Ear pain', 'Fatigue', 'Feeling abnormal', 'Skin warm']",1,JANSSEN,SYR 1086520,VA,21.0,M,Experienced extreme chills starting at 4 pm and through the evening/night. At about 3 am I started getting very sore in the left injection arm and throughout my back/shoulders.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,OTH,Armodafinil 150 MG once daily. Viberzi 75 MG twice daily.,None,IBS-D,,Penicillin,"['Arthralgia', 'Back pain', 'Chills', 'Pain in extremity']",1,JANSSEN,IM 1086524,TX,42.0,F,Dizziness Euphoria feeling Diarrhea Cold sweats Sore throat Injection site pain,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,PHM,Over-the-counter Antihistamine,,,,Aspirin Codeine,"['Cold sweat', 'Diarrhoea', 'Dizziness', 'Euphoric mood', 'Injection site pain', 'Oropharyngeal pain']",1,JANSSEN,SYR 1086528,NJ,20.0,F,"Nausea, hot and cold, lethargic.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,None,None,None,,None,"['Feeling of body temperature change', 'Lethargy', 'Nausea']",1,JANSSEN,SYR 1087173,OK,35.0,F,"After getting it I went home and slept about 3 hours and woke up with fever of 99.3. Had a pounding headache that Tylenol nor ibuprofen could relieve. Body began to ache to the point I was in tears. Checked fever again and was at 99.9. Took more Tylenol and Ibuprophen and went to bed as much as I could. Woke up and took Tylenol the next morning. Checked temperature because I still had a pounding headache and was at 100.2, started sweating and shaking as in cold sweats. No appetite. Spent most of the day resting with most symptoms still accruing. On 3rd day I have no fever. I?m not as weak and I?m able to get around a lot better. Still a little nauseous but definitely feeling better then the previous days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,PHM,"Felodipine, hydrchlorothiazide",,,,Sulfa,"['Cold sweat', 'Decreased appetite', 'Headache', 'Hyperhidrosis', 'Nausea', 'Pain', 'Pyrexia', 'Tremor']",1,JANSSEN,SYR 1086853,ND,,U,"severe allergic reaction; A spontaneous report was received from a health care professional, concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine and experienced severe allergic reaction. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, approximately 15 minutes prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced a severe allergic reaction. The symptoms were discovered during the 15 minute, post-vaccination observation period. The patient had no prior history of anaphylactic reactions. The patient was not hospitalized. Treatment information was not provided. The second dose of mRNA-1273 was discontinued in response to the event. The event severe allergic reaction was considered Recovered/Resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested. Hypersensitivity is considered listed.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported Medical history),,,['Hypersensitivity'],1,MODERNA,OT 1086854,NE,,U,"Administered Moderna COVID-19 Vaccine to a 17 year old patient; A spontaneous report was received from a healthcare facility staff member, concerning a 17-year-old, who was administered Moderna's COVID-19 vaccine (mRNA-1273) (PT: Product administered to patient of inappropriate age). The patient's medical history was not provided. No relevant concomitant medications were reported. On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown)intramuscularly for prophylaxis of COVID-19 infection. On 07 Jan 2021, the 17-year-old patient was administered their first dose of vaccine. No additional information was provided. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered Moderna COVID-19 Vaccine to a 17-year-old patient, was considered resolved on 07 Jan 2021.; Reporter's Comments: This case concerns a 17-year-old patient of unknown gender who received their first of two planned doses of mRNA-1273 (Lot # unknown), reporting Product administered to patient of inappropriate age without any associated adverse events. Event considered resolved.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/07/2021,01/07/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Product administered to patient of inappropriate age'],1,MODERNA,OT 1086855,AL,,M,"Cellulitis; Heat from injection site; Swelling; became red; Injection site pain; A spontaneous report was received from a Consumer concerning a 37-years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Erythema, Injection site warmth, Swelling, Cellulitis and Injection site pain. The patient's medical history was not provided. Relevant concomitant medications were reported as Monopost, Multivitamins, Lisinopril. On 29 DEC 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced Erythema, Injection site joint discomfort, Swelling, Cellulitis. On 29 DEC 2020, the patient experienced Injection site pain. His arm began to hurt the day of injection and continued for about a week after the injection. Arm pain began to subside for a day or two. After a few days arm swelled again and became red or started generating heat. Patient went to the Emergency Room for treatment and was diagnosed with Cellulitis. No Laboratory details were provided. Treatment information was provided as Tylenol and Antibiotics. Action taken with mRNA-1273 in response to the events was unknown. On an unknown date, the outcome of the events was recovered.; Reporter's Comments: This case concerns a 37-year-old male who experienced serious unexpected cellulitis, serious expected swelling, NS unexpected injection site warmth and NS expected injection site pain and erythema. Event onset was the same day as the first dose of mRNA-1273. Treatment with Tylenol and antibiotics. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/29/2020,12/29/2020,0.0,UNK,LISINOPRIL; MONOPOST; MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,"['Cellulitis', 'Erythema', 'Injection site pain', 'Injection site warmth', 'Swelling']",1,MODERNA,OT 1086856,IA,,U,"2 uncapped vials thawed out in room temperature placed back in the refrigerator and administered to 22 patients next day; 2 uncapped vials thawed out in room temperature placed back in the refrigerator and administered to 22 patients next day; A spontaneous report, was received from a nurse concerning, 22 patients who received Moderna's COVID-19 Vaccine and who experienced two uncapped vials thawed out in room temperature, and placed back in the refrigerator and administered to 22 patients the next day/Product temperature excursion issue and Out of specifications product use. The patients medical history's were not provided. concomitant product use was not provided. On 17-Feb-2021, prior to the onset of events, a Healthcare Provider had 2 uncapped vials of mRNA-1273 (Batch numbers unknown) thawed out in room temperature (around 70 degrees Fahrenheit) for approximately two hours. These vials were placed back in the refrigerator (4-5 degrees Centigrade) for approximately 24 hours. On 18-Feb-2021, 22 patients received a dose of mRNA-1273 intramuscularly for COVID-19 prophylaxis and were administered vaccine from the previously thawed vials. Action taken with mRNA-1273 in response to the event was unknown. The reported event, Two uncapped vials thawed out in room temperature, placed back in the refrigerator and administered to 22 patients the next day, outcome was considered resolved on 18 Feb 2021.; Reporter's Comments: This report refers to a case of product storage error and out of specification product use for mRNA-1273 administered to 22 patients, (lot # not provided) with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/18/2021,02/18/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (Medical history not provided),,,"['Poor quality product administered', 'Product temperature excursion issue']",1,MODERNA,OT 1086857,,,M,"Facial palsy reaction; A spontaneous report was received from a consumer (patients wife) concerning an male patient of unknown age who experienced the event facial paralysis. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event facial palsy. Information about treatment was not provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event facial palsy was unknown. ; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Facial paralysis'],UNK,MODERNA, 1086858,FL,39.0,U,"Anaphylaxis; low blood pressure; experienced flushing; nausea; A spontaneous report was received from a consumer concerning a 39-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events anaphylaxis, flushing, nausea, and low blood pressure. The patient's medical history included allergy to medications (information not reported). Concomittent meds included Xyrem (for narcolepsy/cataplexy) and Adderall (narcolepsy) On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27 Jan 2021, 20 minutes after the vaccine the patient experienced flushing. nausea, low blood pressure (reading unknown). Patient was premedicated with Benadryl and Xyzal because of known history of allergy to medications. Treatment details were not reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events were reported as resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Anaphylactic reaction', 'Flushing', 'Hypotension', 'Nausea']",1,MODERNA,OT 1086859,PA,,M,"difficulty talking; unable to move his arm or leg; Massively sick; body pain; Nausea; headaches; fatigue; muscle aches and pains; chills; A spontaneous report was received from a 79-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced ""unable to move his arm or leg"", massively sick, nausea, headache, body pains, difficulty talking, fatigue, muscle aches and pains and chills. The patient's medical history included Covid-19 positive on 17-OCT-2020. Concomitant product included metformin, metoprolol and rivaroxaban. On 04-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly for prophylaxis of COVID-19 infection. On 04-FEB-2021, one day after receiving the vaccine, the patient felt ""crummy"", ""massively sick"", nausea, headaches, fatigue, chills, muscle aches and pains and other pains. On 05-FEB-2021, the patient reported that he believed he was having a stroke. The patient was unable to move his arm or leg and had difficulty talking. The patient was taken to the emergency room for treatment. Computerized tomogram (CT) scan and magnetic resonance imaging (MRI) were taken. Later that night, after receiving treatment all his side effects subsided and none were present at the time of this report. The patient would like to know if he should get the second dose of vaccine. Treatment information included heparin, acetaminophen and magnesium. Action taken with mRNA-1273 was unknown. The outcome of the events, unable to move his arm or leg, massively sick, nausea, headache, body pains, difficulty talking, fatigue, muscle aches and pains and chills, was resolved. The reporter did not provide the assessment for the events unable to move his arm or leg, massively sick, nausea, headache, body pains, difficulty talking, fatigue, muscle aches and pains and chills.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Yes,Y,02/04/2021,02/04/2021,0.0,UNK,METFORMIN; METOPROLOL; XARELTO,,Medical History/Concurrent Conditions: COVID-19,,,"['Chills', 'Fatigue', 'Headache', 'Illness', 'Mobility decreased', 'Myalgia', 'Nausea', 'Pain', 'Speech disorder']",1,MODERNA,OT 1086860,,88.0,F,"abnormal heart beat; felt a tingling in her chest; A spontaneous report was received from a consumer concerning an 88-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt a tingling in her chest (paraesthesia), and abnormal heart beat (arrhythmia). The patient's medical history was not provided. No relevant concomitant medications were reported. On 3 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 3 Feb 2021, the patient felt a tingling in her chest. Three weeks later, on 14 Feb 2021, the patient was admitted to the hospital for an abnormal heart beat. No treatment information was provided. At the time of this report, the patient was still suffering from the symptoms. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, felt a tingling in her chest and abnormal heartbeat, were not recovered/not resolved.; Reporter's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/03/2021,02/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Arrhythmia', 'Paraesthesia']",1,MODERNA,OT 1086861,,,M,"3rd dose of the vaccine 28 days after the second one; A spontaneous report was received from a health professional concerning a male patient in his 60s who received extra dose administered. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 22 Feb 2021, prior to the onset of the symptoms, the patient received their third dose of mRNA-1273 (Batch number: Batch number not provided) for prophylaxis of COVID-19 infection. On 22 Feb 2021, five patients received third dose of the mRNA-1273 vaccine, 28 days after the second one. Action taken with the drug in response to the event was not applicable. The outcome of the event was recovered/resolved.; Reporter's Comments: This case concerns a male patient of unknown gender and age who received their third dose of mRNA-1273 (Lot unknown), reporting Extra dose administered without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,['Extra dose administered'],3,MODERNA, 1086862,,,F,"3rd dose 28 days after the 2nd one; A spontaneous report was received from a pharmacist and a consumer concerning a female patient, (5 patients, all of the patients were in their 60's according to the reporter), who received third dose 28 days after the second dose of Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not reported by the reporter. Concomitant medication was not reported. On an unknown date, prior to the onset of the event, all the five patients received their first and second doses of mRNA-1273 (Lot number: unknown) through an unknown route at an unspecified site for prophylaxis of COVID-19 infection. On 22 Feb 2021 at 2:22 pm, these five patients received their third dose of mRNA-1273 (Lot number: unknown) through an unknown route at an unspecified site for prophylaxis of COVID-19 infection. The third dose was 28 days after the second one, which had also been given 28 days after the first dose in all five cases. The nurse obviously gave the 3 doses 28 days apart from each other. Treatment activities for event was unknown. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of event, received third dose 28 days after the second dose of Moderna's COVID-19 vaccine (mRNA-1273) was resolved; Reporter's Comments: This case concerns a female patient who received their third dose of mRNA-1273 (Lot unknown), reporting Extra dose administered without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Extra dose administered'],2,MODERNA,OT 1086863,TX,70.0,M,"Pneumonia in left lung; A spontaneous report was received from a consumer concerning a 70-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed pneumonia in the left lung/pneumonia. The patient's medical history included a heart transplant and diabetes. No concomitant product use was reported. On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) in the left arm intramuscularly for prophylaxis of COVID-19 infection. On unknown date, post vaccination, the patient developed pneumonia in the left lung and was hospitalized. Treatment information included an unspecified antibiotic. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, pneumonia in the left lung/pneumonia, was considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/15/2021,,,UNK,,Diabetes,Medical History/Concurrent Conditions: Heart transplant (Heart transplant occurred 5 years ago.),,,['Pneumonia'],1,MODERNA,OT 1086864,IN,,F,"Covid-19 Positive; low oxygen level; Chills; Headache; Fatigue; Redness; A spontaneous report was received from a consumer concerning a female patient of 79 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and tested positive for covid-19 and experienced low oxygen level, chills, headache, fatigue and redness. The patients medical history was not provided.No relevant Concomitant medications were reported. On 05 Feb 2021, prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 030L20A ) vaccine intramuscularly for prophylaxis of COVID-19 infection. On 06 Feb 2021, one day after vaccination, patient experienced chills, headache, fatigue and redness. On an unknown date, patient experienced low oxygen level and tested positive for covid-19, patient was hospitalized. No Treatment information for the event was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events covid-19 positive, low oxygen level, chills, headache, fatigue and redness was not reported.; Reporter's Comments: Based on the current available information, the mRNA-1723 does not contain a virus and with the occurrence of a Covid-19 Positive test after vaccination, this event is as unlikely related to mRNA-1273. However, the events of chills, headache, fatigue and redness are possibly related to mRNA-1273 administered.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/05/2021,02/06/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['COVID-19', 'Chills', 'Erythema', 'Fatigue', 'Headache', 'Hypoxia']",1,MODERNA,OT 1086865,CA,54.0,F,"Fainting episode; Arm soreness; A spontaneous report was received from a Consumer concerning a 55-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fainting episode, arm soreness. The patient's medical history was not provided. Concomitant medications reported were Tysabri for drug use for unknown indication. On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 042L20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient experienced the events arm soreness. On 27 Jan 2021, the patient experienced fainting episode. No treatment medication was provided. Action taken with mRNA-1273 in response to the events was not reported. On 27 Jan 2021, the outcome of events fainting episode was resolved. The outcome of events arm soreness was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,TYSABRI,,Medical History/Concurrent Conditions: No adverse event,,,"['Syncope', 'Vaccination site pain']",1,MODERNA,OT 1086866,CA,,M,"potential pneumonia; COVID-19 positive; shortness of breath; cough; fever; delirious; taking pants off; couldn't speak; incoherent; would not eat or drink; would not eat; A spontaneous report was received from a consumer concerning a 83-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed shortness of breath, cough, fever, delirious, taking pants,off, couldn't speak, incoherent, would not eat or drink. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not reported. On 28 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 043L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 30 Jan 2021, the patient developed shortness of breath, cough, fever, delirious, taking pants, off, couldn't speak, incoherent, would not eat or drink. 02 Feb 2021 Patient was admitted into the hospital. Patient tested positive for COVID-19. Patient was on a respirator with potential pneumonia. Treatment for the event was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However , the mRNA-1723 does not contain a virus and with the occurrence of Covid-19 positive test after vaccination, the event of Covid -19 is unlikely related to mRNA-1273.",Not Reported,,Yes,Yes,,Not Reported,U,01/28/2021,01/30/2021,2.0,UNK,,COVID-19 (Patient tested positive for COVID-19); Pneumonia (potential pneumonia),,,,"['Abnormal behaviour', 'Aphasia', 'COVID-19', 'Cough', 'Delirium', 'Dysphagia', 'Dyspnoea', 'Food refusal', 'Incoherent', 'Pneumonia', 'Pyrexia']",1,MODERNA,OT 1086867,MS,,F,"Collapsed lung; A spontaneous report was received from a consumer concerning herself, a 79 year old patient who received Moderna's COVID-19 vaccine and experienced collapsed lung. The patient's medical history included COPD. On 8 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number:025L20A) and on 5 Feb 2021, the second dose of mRNA-1273 (Batch number:032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. The event collapsed lung was experienced in Feb 2021 that lead to hospitalization for about 3 days. The patient reported that she has performed a biopsy on Feb 2021. Treatment for the event included IV steroids and oral prednisone. The reporter has also mentioned that the event, collapsed lung is not related to the vaccine. Action taken with mRNA-1273 in response to the event(s) was unknown. The outcome of the event collapsed lung was not recovered/resolved.; Reporter's Comments: Based on the current available information, which includes a pre-existing history of COPD and the time to event onset from vaccine administration, a causal relationship between the event and product use is assessed as unlikely.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/08/2021,02/01/2021,24.0,UNK,,COPD,,,,['Pneumothorax'],2,MODERNA,OT 1086868,IL,72.0,M,"Passed away; Severe hypotension; Hemodialysis shunt bleeding; A spontaneous report was received from other health professional concerning a 72 years old, male patient who experienced hypotension, removal and replacement of hemodialysis shunt (procedure), hemodialysis shunt bleeding and death. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 29-DEC-2020, the patient received their first of two planned doses of mRNA-1273 (Batch number [LOT/BATCH: 039K208] intramuscularly in the right arm for prophylaxis of COVID-19 infection. The patient was hospitalized for severe hypotension and Removal and Replacement of hemodialysis shunt from 17-JAN-2021 to 21-Jan-2021. On 26-01-2021 the patient was sent to hospital due to his hemodialysis shunt bleeding. On 27-01-2021, the patient passed away at the hospital . Treatment information was unknown. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 27 Jan 2021. The cause of death was unknown. Plans for an autopsy were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death",Yes,01/27/2021,Not Reported,Not Reported,,Not Reported,N,12/29/2020,01/17/2021,19.0,SEN,,,Medical History/Concurrent Conditions: Surgical vascular shunt,,,"['Death', 'Hypotension', 'Medical device site haemorrhage']",1,MODERNA,OT 1086869,MI,,F,"Stroke; A spontaneous report was received from a consumer who was also a 66-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced stroke. The patient's medical history was not provided by the reporter. Concomitant medications included Lisinopril, Rosuvastatin, Montelukast, Hydrochlorothiazide, Sertraline, Metoprolol, and Zyrtec. The patient received their first of two planned doses of mRNA-1273 (Batch number: 029L201A) on 12 Feb 2021, approximately one day prior to the onset of the symptoms in the left non-dominant arm for prophylaxis of COVID-19 infection. The patient experienced a stroke on the night of 13 Feb 2021- 14 Feb 2021. The patient could not speak properly due to being drowsy. On unspecified date the patient was hospitalized for the event of stroke and released on 16 Feb 2021. Treatment for the event included double cholesterol med (from 10 to 20 mg) and baby aspirin. No relevant laboratory details were included. Action taken with the drug in response to the event was not reported. Outcome of the event was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of stroke, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/12/2021,02/13/2021,1.0,UNK,LISINOPRIL; ROSUVASTATIN; MONTELUKAST; HYDROCHLOROTHIAZIDE; SERTRALINE; METOPROLOL; ZYRTEC R,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Cerebrovascular accident'],1,MODERNA,OT 1086870,IL,76.0,M,"Neck mass; A spontaneous report was received from a health care professional concerning a 76-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced neck mass. The patient's medical history was not provided by the reporter. No concomitant medications were reported. On 12 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On the 19 Jan 2021, prior to receiving mRNA-1273, the patient experienced neck mass. Patient was hospitalized from 19 Jan 2021 to 25 Jan 2021. No treatment details were provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, neck mass, is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,7.0,Not Reported,U,12/30/2020,01/19/2021,20.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No adverse event reported),,,['Neck mass'],1,MODERNA,OT 1086871,WI,,F,"Miscarriage; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 41-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event miscarriage/ abortion spontaneous and vaccine exposure during pregnancy. The patient's medical history included environmental allergies and an allergy to an unknown beauty product, kidney stone, endometriosis, anxiety, and paroxysmal supraventricular tachycardia. Products known to have been used by the patient, within two weeks prior to the event, included pre-natal vitamins and escitalopram oxalate. The patient received their first of two planned doses of mRNA-1273 (Batch number: 042L20A) intramuscularly on 14 Jan 2021. On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2020, the patient had a positive pregnancy test. The first day of the patient's last menstrual period was on 24 Dec 2020. The estimated date of conception was not provided. The due date was estimated as 30 Sep 2021. On 22 Feb 2021, the patient had a miscarriage. There was no fetal heartbeat on the ultrasound. On 24 Feb 2021, the patient underwent a procedure to complete the miscarriage. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events was considered recovered.; Reporter's Comments: This is a case of product exposure during pregnancy with an Adverse event of Spontaneous abortion for this 41-year-old female. Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/14/2021,01/14/2021,0.0,UNK,PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; LEXAPRO,,Medical History/Concurrent Conditions: Anxiety; Cosmetic allergy (an allergy to an unknown beauty product); Endometriosis; Environmental allergy (environmental allergies); Kidney stone; Paroxysmal supraventricular tachycardia,,,"['Abortion spontaneous', 'Blood test', 'Exposure during pregnancy', 'Human chorionic gonadotropin', 'Sexually transmitted disease test', 'Ultrasound abdomen', 'Urine analysis']",1,MODERNA,OT 1086872,NC,85.0,M,"Very slow heart beat; A spontaneous report was received from an 85 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a very slow heartbeat. The patient's medical history was not provided. Concomitant medications were not reported. On 25-FEB-2021, prior to the onset of the event, the patient received his first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On an unspecified date after receiving the mRNA-1273 vaccine, the patient developed a very slow heartbeat. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/25/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Heart rate decreased'],1,MODERNA,OT 1086873,,,U,"vaccine underdose; syringe connection issues; A spontaneous report received from a Healthcare Professional (pharmacist) concerning, patient of unspecified age and gender who received dose of the Moderna COVID-19 vaccine and developed syringe unscrewed itself twice and HCP do not know how much the patient received. The patient's medical history was not included. Patient's concomitant was not included. On unknown date, the patient received their dose of the two planned doses of mRNA-1273 in unknown arm (Batch number not provided) for prophylaxis of COVID-19 infection. Healthcare Professional stated that the patient was given Moderna COVID-19 Vaccine. Healthcare Professional stated that the syringe unscrewed itself twice and he did not know how much vaccine the patient received. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event syringe unscrewed itself twice and HCP do not know how much the patient received was unknown.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273. There were no reported adverse events associated with this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Device connection issue', 'Underdose']",1,MODERNA, 1086874,,,M,"Paralysis of entire body; A spontaneous report was received from a consumer concerning a 79-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced paralysis of his entire body. The patient's medical history was not provided. Concomitant products included Evolocumab, blood pressure medication and metformin. The patient received the first of two planned doses of mRNA-1273 (Batch number: unknown). The date of administration of first dose of vaccine was not mentioned. On 19 Feb 2021, approximately one day prior to the onset of the event, the patient received the second dose of two planned doses of mRNA-1273 (Batch number:006M20A) intramuscularly for prophylaxis of COVID-19 infection. On 20 Feb 2021, Patient experienced paralysis of his entire body at night and the ambulance had to come to put him back in bed. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The event paralysis of his entire body, was considered resolved on 21 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Yes,Y,02/19/2021,02/20/2021,1.0,UNK,REPATHA; METFORMIN,,Medical History/Concurrent Conditions: No adverse event (No medically reported history),,,['Paralysis'],1,MODERNA,OT 1086875,MA,78.0,F,"Retinal hemorrhage inside left eye; Impaired vision; Occular migraine; Swelling inside left eye; Severe headache; A spontaneous report was received from a reporter like consumer concerning a 78-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like retinal haemorrhage, eye inflammation, headache, visual impairment, retinal migraine. The patient's medication history was not provided. Concomitant medications were not provided. On 17 Feb 2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch 030M20A) intramuscularly in the anatomical location for prophylaxis of COVID-19 infection. On 18 Feb 2021, 28 hours following the vaccine administration, the patient experienced events like very small hemorrhage inside left eye, swelling inside the left eye, headache, impaired vision, ocular migraine with swelling inside the eye being medically significant. Laboratory details were not provided. No treatment information was provided. The outcome of the event was unknown. Action taken with mRNA-1273 in response to the events were not reported.; Reporter's Comments: Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded. Headache is consistent with the known safety profile of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/18/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Eye inflammation', 'Headache', 'Retinal haemorrhage', 'Retinal migraine', 'Visual impairment']",1,MODERNA,OT 1086876,NY,79.0,M,"Wasn't feeling good due to other reasons; Its past 42days of 1st shot; A spontaneous report was received from a consumer concerning a 79 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced wasn't feeling good due to other reasons and it's past 42 days of 1st shot. The patient's medical history included chronic obstructive pulmonary disease. Relevant concomitant medications included salbutamol, budesonide, formoterol fumarate and tiotropium bromide. On 13-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 23-Feb-2021, the patient was not feeling good due to other reasons as he has chronic obstructive pulmonary disease (COPD) and was hospitalized. The patient tested negative for COVID-19 on an unknown date. On 25-Feb-2021, the patient was discharged. No treatment information was provided. The outcome of the event, it's past 42 days of 1st shot, was resolved. The outcome of the event, wasn't feeling good due to other reasons, was unknown.; Reporter's Comments: This case concerns a 79-year-old, male patient with a medical history of chronic obstructive pulmonary disease who experienced unexpected event of past 42 days of 1st shot (inappropriate schedule of vaccine administration) and not feeling good. The event of not feeling good was attributed to the underlying COPD.as such, assessed s unlikely due to vaccine administration. Inappropriate schedule of vaccine administration is assessed as not applicable.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/13/2021,01/13/2021,0.0,UNK,ALBUTEROL [SALBUTAMOL]; SYMBICORT; SPIRIVA,COPD,,,,"['Malaise', 'Product dose omission issue', 'SARS-CoV-2 test']",1,MODERNA,OT 1086877,CO,94.0,M,"low grade UTI; collapse; been kind of weak; A spontaneous report was received from a consumer, who was the caregiver of a 94-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection (UTI), collapse (syncope), and weak (asthenia). The patient's medical history was provided. Concomitant product use was not provided. On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number 029L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. The patient was hospitalized for a UTI from 10 Feb 2021 to 12 Feb 2021. The reporter stated, ""after that, he's been kind of weak and everything"". The reporter indicated it was a ""low grade"" UTI and the patient didn't show any symptoms but then stated ""it actually had him collapse and he did that in between the two vaccines and spent two days in the hospital."" On 17 Feb 2021, the patient received his second of two planned doses of mRNA-1273 (batch number 012M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. The patient received both planned doses of mRNA-1273; therefore, the action with mRNA-1273 in response to the events was not applicable. Treatment for the UTI included nitrofluorine. The outcome of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/22/2021,02/10/2021,19.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Asthenia', 'Syncope', 'Urinary tract infection']",2,MODERNA,OT 1086878,,,F,"Passed out; Nausea; Fever; Chills; A spontaneous report was received from an other healthcare professional for a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced fever, chills, nausea and passed out for a short duration. The patient's medical history was not provided. No concomitant product use was reported. On 26 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. After receiving the vaccine, the patient had experienced chills and fever overnight. On 27-Feb-2021, the patient developed nausea and reportedly passed out for a short duration while coming out of shower which was followed by a second episode of passing out while dressing. As per the patient this could be related to dehydration and low blood pressure in general. The patient was feeling fine at the time of this report. Treatment information was unknown. Action taken with mRNA-1273 was not applicable. The outcome of the events, fever, chills, nausea and passed out for a short duration, were considered as recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: MOD-2021-029837:Same reporter, Male patient",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/26/2021,02/26/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Low blood pressure,,,"['Chills', 'Loss of consciousness', 'Nausea', 'Pyrexia']",2,MODERNA,OT 1086879,TX,61.0,F,"Bell's Palsy; diarrhoea; fever between 98-99 degree Fahrenheit; several headache; nausea; A spontaneous report was received from a consumer concerning a 61-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bell's palsy, diarrhea, fever between 98-99-degree Fahrenheit, several headache and nausea. The patient's medical history included: Covid-19 (start date 08-JAN-2021). No relevant concomitant medications were reported. On 8-FEB-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch:012M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 09-FEB-2021, the patient's symptoms had started. The patient mentioned a fever between 98�F - 99�F, headache, nausea, and diarrhea. Then on 15-FEB-2021, she had a (facial) paralysis, the left side of the mouth bent to the side and the eye fell. On 20-FEB-2021, the patient had visited the doctor's office and she was diagnosed with Bell's palsy. The patient was treated with, prednisone , valacyclovir, injection (unspecified) like a Cortisone. At the time of this report everything was coming back to normal, but it was not at 100%. The adverse event of ball's palsy was assessed as medically significant. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event of bell's palsy, diarrhea, fever between 98-99-degree Fahrenheit, several headache and nausea was resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/09/2021,1.0,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"[""Bell's palsy"", 'Diarrhoea', 'Headache', 'Nausea', 'Pyrexia']",1,MODERNA,OT 1086880,,,F,"anaphylactic shock; facial swelling significantly increased; A spontaneous report was received from a consumer concerning a female patient(unknown age), who received Moderna's covid-19 vaccine(mRNA-1273) and experienced anaphylactic shock and facial swelling. Patient's medical history was not provided. No relevant concomitant medications were mentioned. On 29 Jan 2021, one day prior to the onset of events, patient received mRNA-1273 vaccine(Lot number:unknown) for prophylaxis of covid-19 infection. On 30 Jan 2021, around 3:30pm, patient started experiencing swelling of face. By 5:00 pm, she went into complete anaphylactic shock and was hospitalized. Lab investigations included high WBC, high absolute neutrophil, high absolute monocytes and low carbon dioxide. Treatment medications included two injections of epinephrine(Adrenalin),two injections of diphenhydramine(Benadryl),an injection of methylprednisolone(SOLU-Medrol),an injection of Famotidine(Pepcid),one litre of sodium chloride(Normal saline),and Acetaminophen(Tylenol).She was discharged with an EpiPen and another prescription of Prednisone(20mg). Action taken with mRNA-1273 in response to the event was not reported. Outcome of the event, anaphylactic shock was not reported, whereas, the outcome of facial swelling was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Yes,Yes,,Not Reported,N,01/29/2021,01/30/2021,1.0,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No adverse event, Continue: [UNK], Comment: No reported medical history",,,"['Anaphylactic shock', 'Carbon dioxide', 'Monocyte count', 'Neutrophil count', 'Swelling face', 'White blood cell count']",1,MODERNA, 1086881,IA,87.0,M,"headache; atrial fibrillation with abnormal heart rate; A spontaneous report was received from a consumer concerning a 87 years old, male patient who experienced atrial fibrillation with abnormal heart rate/ PT: Atrial fibrillation and mild headache. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included unspecified medications. On 03 Feb 2021 (at 2:01 pm), approximately three hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly for prophylaxis of COVID-19 infection. On 03 Feb 2021 (at 5:00 pm), approximately 3 hours later, the patient experienced atrial fibrillation with abnormal heart rate. The patient's heart rate was 145. The patient went to the emergency room and the cardiologist gave him a pill to lower the heart rate. The patient was also told to take his regular pills and was sent home. The patient reported having atrial fibrillation for the past five days and that he had a scheduled appointment with his health care professional for an EKG on another date. On an unknown date, the patient also reported that he experienced mild headache. The event atrial fibrillation with abnormal heart rate was considered medically significant. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, atrial fibrillation with abnormal heart rate and mild headache, was not reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Atrial fibrillation', 'Headache', 'Heart rate']",1,MODERNA,OT 1086882,IL,28.0,F,"Anaphylactic reaction; A spontaneous report was received from a consumer concerning a 28 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed anaphylactic reaction. The patient's medical history and concomitant medications were not provided. On an unknown date, approximately three weeks prior to the onset of the event, the patient received her first of two doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient developed an anaphylactic reaction. Treatment information was not provided. The patient wanted to know if the Moderna vaccine contains shellfish and shark ingredients. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, anaphylactic reaction, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history provided),,,['Anaphylactic reaction'],1,MODERNA,OT 1086883,VA,19.0,M,"Perimyocarditis post covid19 vaccine syndrome; A spontaneous report was received from a physician concerning a 19 year old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced perimyocarditis post covid19 vaccine syndrome. The patient's medical history was not provided. No concomitant medications were reported. On 16 Feb 2021, approximately six days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013L20A) for prophylaxis of COVID-19 infection. On 22 Feb 2021 the patient experienced the symptoms following vaccination: perimyocarditis post covid19 vaccine syndrome. No treatment information was provided. No relevant laboratory details were included. The seriousness criteria for the event perimyocarditis post covid19 vaccine syndrome were hospitalization and medically significant. Action taken with the drug in response to the event was unknown. The outcome of the event, perimyocarditis post covid19 vaccine syndrome was reported resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/16/2021,02/22/2021,6.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Myocarditis'],1,MODERNA, 1086884,NJ,,M,"blood pressure went up to 23-24 mmHg/blood pressure high; A spontaneous report was received from a 48 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and his blood pressure went up to 23-24 mmHg/blood pressure increased. The patient's medical history included bariatric surgery. Concomitant medications included losartan. On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. The patient reported that his blood pressure ""went up to 23-24 mmHg"" and he was hospitalized two times, one of the times was on 25 Jan 2021. He reported that his blood pressure ""does not go down"" and that labs tests were being performed to determine the relationship with the vaccine. AN electrocardiogram and radiography were normal. On 25 Jan 2021, the patient was hospitalized due to high blood pressure which was 23-24 mm Hg. On 25-Jan-2021, the electrocardiogram and radiography findings were normal. The patient's blood pressure was 17-19 mm Hg at the time of this report. The patient was worried because of the consequences of blood pressure high. Losartan was changed to amlodipine as treatment for the event. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event of blood pressure went up to 23-24 mmHg/blood pressure high was unknown; at the time of reporting, the patient said his blood pressure was ""between 17-19 mmHg.""; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/23/2021,01/25/2021,2.0,UNK,LOSARTAN,,Medical History/Concurrent Conditions: Bariatric surgery (2017),,,"['Blood pressure increased', 'Blood pressure measurement', 'Electrocardiogram', 'Therapeutic aspiration']",1,MODERNA,OT 1086885,MA,44.0,F,"Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid heart rate; nausea; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration on 21Jan2021 at 16:00 at a single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies, some environmental allergies, some heart issues specified as SVT, slight asthma, and lung damage. Prior to vaccination, the patient was diagnosed with COVID-19 on 26Dec2020 (also reported as possibly had COVID in Mar2020, however no tests were available; patient was told to quarantine). On 31Dec2020, COVID-19 test showed a positive result. The patient recovered on 09Jan2021, two weeks from onset of symptoms. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. On 21Jan2021 at 16:15, the patient experienced the following adverse events: flushed, over heated, rash/hives on chest, dry mouth, swollen tongue, rapid heart rate, nausea, headache, and weakness. The events resulted to emergency room visit and doctor office visit. The patient received two epi shots, allergy and anti-nausea medications as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/21/2021,01/21/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Asthma; COVID-19; Environmental allergy; Lung disorder; Seasonal allergy; Supraventricular tachycardia,,,"['Asthenia', 'Dry mouth', 'Feeling hot', 'Flushing', 'Headache', 'Heart rate', 'Heart rate increased', 'Nausea', 'Rash', 'SARS-CoV-2 test', 'Swollen tongue', 'Urticaria']",1,PFIZER\BIONTECH, 1086886,TX,39.0,M,"My blood pressure, which normally runs low, dipped very low (85/55); I had pretty severe brain fog. I never blacked out, but I was concerned I might.; This is a spontaneous report from a contactable consumer reporting for himself. A 39-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246), via an unspecified route of administration on 23Jan2021 on right arm at single dose for COVID-19 immunization. Facility type vaccine was at hospital. Medical history included small fiber neuropathy, dysautonomia/vasovagal syncope, ineffective esophageal motility disorder, migraine, GERD, allergic to preservatives in many eye drops, but never a vaccine; allergic to dust mites. Concomitant medications included nadolol, midodrine, esomeprazole magnesium (NEXIUM), amitriptyline and other unspecified medications. The patient stated ""My blood pressure, which normally runs low (I have dysautonomia/vasovagal syncope) dipped very low (85/55) and I had pretty severe brain fog. I never blacked out, but I was concerned I might."" The reported events happened on 25Jan2021 18:00, and resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events were resolved in 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/23/2021,01/25/2021,2.0,PVT,NADOLOL; MIDODRINE; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; AMITRIPTYLINE,,Medical History/Concurrent Conditions: Dysautonomia; Esophageal motility disorder; GERD; House dust mite allergy; Migraine; Reaction to preservatives; Small fiber neuropathy; Syncope vasovagal,,,"['Blood pressure measurement', 'Feeling abnormal', 'Hypotension']",1,PFIZER\BIONTECH, 1086887,GA,,M,"ITP (platelet count 1,000); This is a spontaneous report from a contactable physician (patient). A 31-years-old healthy male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The historical vaccine included MMR vaccine in Nov2020 (3 months before 08Feb2021) for immunization and idiopathic thrombocytopenic purpura (ITP). The patient presented with ITP (platelet count 1,000) approximately 2.5 weeks after receiving the 2nd dose of the Pfizer COVID vaccine. Hepatitis C Antibody (reported as Hep. C Ab) was negative. HIV-Ab was pending. The reporter knew there were cases reports of ITP associated with COVID-19 infection. The events outcome was unknown. The reporter asked had anyone noted COVID vaccination-related ITP? He received the MMR vaccine (which has been associated with ITP) 3 months ago. Was it too far out to attribute this case of ITP to the MMR vaccination? Information on the Batch/Lot number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event immune thrombocytopenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['HIV antibody', 'Hepatitis C antibody', 'Immune thrombocytopenia', 'Platelet count']",2,PFIZER\BIONTECH, 1086888,,,F,"cellulitis; This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient is taking Bactrim for cellulitis and is due for the second dose of the vaccine. Outcome of the event was unknown. Information on lot/batch number has been requested.; Sender's Comments: The association between the event cellulitis with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Cellulitis'],1,PFIZER\BIONTECH, 1086889,,,M,"UTI; respiratory distress; elevated BP; tachycardia; This is a spontaneous report from a contactable nurse received via Medical Information Team. A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced urinary tract infection (UTI) (hospitalization) on an unspecified date; respiratory distress, elevated blood pressure (BP) and tachycardia, all on 15Jan2021. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 15Jan2021. The patient outcome of the events was unknown. Information on the lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the respiratory distress, elevated blood pressure and tachycardia due to temporal relationship. Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event UTI, which may likely represent intercurrent medical condition. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG, arterial blood gas and physical examination, counteractive treatment measures and concomitant medications. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/15/2021,01/15/2021,0.0,UNK,,,,,,"['Blood pressure increased', 'Blood pressure measurement', 'Respiratory distress', 'Tachycardia', 'Urinary tract infection']",1,PFIZER\BIONTECH, 1086890,NY,69.0,F,"her lymph node in her breast is killing her; breast pain/ she is not sleeping well due to the pain; thought she pulled a muscle at first; tired; not sleeping well due to the pain; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EL9267), via an unspecified route of administration on the left arm, second dose on 17Feb2021 at single dose, for COVID-19 vaccination. The patient's medical history was not reported. There were no concomitant medications. Patient took the first dose of Pfizer-BioNTech COVID-19 mRNA vaccine (Lot: EL9264) on 27Jan2021 for COVID-19 vaccination. Patient got her second dose of the Pfizer Covid vaccine 17Feb2021 and experienced side effects such as painful lymph node and breast pain on 18Feb2021. She said that her lymph node in her breast is killing her on the side that she had the vaccine. She clarified that it is very painful and her breast itself is very painful. She said that she did go to the doctor to be sure that is what it was. She further reported that by Thursday night (18Feb2021), it started bothering and her breast started bothering her. She thought she pulled a muscle at first. She said that it has progressed and got worse and that Sunday night she was in agony. She called the doctor Monday for her left breast that hurts. She said that she is taking ibuprofen (ADVIL, Lot: DJ6716, Expiration: Dec2022), taking 3 of them at a time, but it is not really helping. She had no reaction at the injection site. It is not red and you cannot see anything there. She said that is why she is not even sure. She said that there was no pain at all there. She said that there is nothing wrong with her and she does not feel sick, she just hurts. She said that she was tired because she is not sleeping well due to the pain. Patient wants to know what pain medication she could use that will not counteract the vaccine. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/18/2021,1.0,UNK,,,,,,"['Breast pain', 'Fatigue', 'Lymph node pain', 'Muscle strain', 'Poor quality sleep']",2,PFIZER\BIONTECH, 1086891,TN,52.0,F,"she was diagnosed with COVID in between the first and second vaccine; she had headache; arm pain at the injection area; severe back spasms in the thoracic and lumbar; made a different in the vision, it was throbbing; back pain; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL0140), intramuscular on 04Jan2021 at single dose at left arm for covid-19 immunization. Medical history included diabetes (diagnosed six years ago. Her last A1C was 6.1 in Dec2020), chronic edema since her last child was born 26 years ago. Concomitant medications included ongoing furosemide (LASIX), ongoing potassium, ongoing omeprazole (PRILOSEC), ongoing metformin, and paracetamol (TYLENOL). Caller received the Pfizer-BioNTech COVID-19 Vaccine first dose on 04Jan2021 and second dose on 27Jan2021. Caller reported to have experienced back pain 2-3 days after the first dose, and a sharp stabbing back pain with moist cough for almost a month now after the second dose. Caller was diagnosed with COVID-19 in between. With the first vaccine she had headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given diclofenac (VOLTAREN) and cefixime (FLEXERIL). She was taking 1 gram of paracetamol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. Seriousness criteria for back pain, it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor; for event arm pain at the injection area, gripping was not easy and moving her arm was painful. She was left handed. Heat worked better than ice. Ice made things worse; for event headache, made a different in the vision, it was throbbing. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of paracetamol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She had been taking 1000mg paracetamol three times a day and now she was taking it two times a day. She was taking cefixime at bedtime because she can't stay awake when she took it. She can't take it and work. She had missed work because of this. She was taking diclofenac twice a day. Patient didn't have the first bottle of paracetamol she used because she had gone through it. Current bottle of Tylenol was the generic, SunMark Acetaminophen. She had to get her glasses to read the lot number. It was made by (Pharmacy name), Lot number: OLE2349B, expiry: Sep2022. She didn't feel like the medication she took were relevant because she had been taking them for a very long time. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021. She got the results of her PCR test on 13Jan2021. Outcome of event back pain was not recovered, outcome of events headache, arm pain at the injection area and severe back spasms in the thoracic and lumbar was recovered in 2021, and outcome of other events was unknown. Relatedness of drug to reaction(s)/event(s): Events headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar: source of assessment: primary source reporter; Method of assessment: global introspection; Drug result: Related.; Sender's Comments: Event back pain represents an intercurrent medical condition and unrelated to bnt162b2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/04/2021,01/01/2021,,UNK,LASIX [FUROSEMIDE]; POTASSIUM; PRILOSEC [OMEPRAZOLE]; METFORMIN; TYLENOL,,Medical History/Concurrent Conditions: Chronic edema (chronic edema since her last child was born 26 years ago.); Diabetes (diagnosed six years ago. Her last A1C was 6.1 in Dec2020.),,,"['Back pain', 'COVID-19', 'Glycosylated haemoglobin', 'Headache', 'Muscle spasms', 'Polymerase chain reaction', 'Vaccination site pain', 'Visual impairment']",1,PFIZER\BIONTECH,OT 1086892,NY,,F,"I am a breastfeeding mother. My daughter (3 months old) ended up hospitalized/very sick; I am a breastfeeding mother. My daughter (3 months old) ended up hospitalized/very sick; This is a spontaneous report from a contactable Other HCP. This Other HCP (Patient's mother) reported for a 3-month-old female patient that received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9269) via transmammary (parent route Intramuscular at Left arm) on 08Feb2021 06:00 PM at single dose for COVID-19 immunization. Medical history was none. Concomitant drugs were not reported. Her mother was a 23 years old female and was a breastfeeding mother, her daughter (3 months old) ended up hospitalized (in Feb2021 for 6 days) and very sick a week and a half after mother received the vaccine. The event start date reported as 16Feb2021 with outcome of recovering. Treatment was unknown. No covid prior vaccination. Covid test post vaccination on 18Feb2021: (Nasal Swab) Negative.; Sender's Comments: Very limited information was provided in this report regarding the clinical course of the event. The reported ""very sick a week and a half after mother received the vaccine"" is unspecified. Pending more detailed information became available, at this moment, the Company cannot completely exclude the possible causality between the reported events and COVID-19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,02/08/2021,02/16/2021,8.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Exposure via breast milk', 'Illness', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1086893,FL,35.0,F,"Bell's Palsy (left side of face paralysis); This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received the 2nd dose (at the age of 35-year-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot# EL8982), via an unspecified route of administration on the left arm on 05Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient had no known allergies and medical history reported as none. There were no concomitant medications. The patient was not pregnant (including the time of vaccination). The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot# EL1283), via an unspecified route of administration on the left arm on 15Jan2021 09:30 (at the age of 35-year-old) for COVID-19 immunization. The patient developed Bell's Palsy (left side of face paralysis) on Friday afternoon 19Feb2021 (2 weeks after second dose of the vaccine). The patient went to the doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care due to the event (which was considered as serious disability or permanent damage). The emergency room (ER) doctor prescribed valacyclovir and prednisone. Outcome of the event was not recovered.; Sender's Comments: Based on temporal relationship and known drug safety profiles, a possible contributory role of suspect drug cannot be excluded for the reported event Bell's Palsy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/05/2021,02/19/2021,14.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"[""Bell's palsy""]",2,PFIZER\BIONTECH, 1086894,AR,43.0,F,"tired; sore arm; Facial droop (left eye and mouth); This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at left arm 23Feb2021 08:00 at single dose for covid-19 immunisation. Medical history included Known allergies: Sulfa drugs, codeine, diastolic dysfunction type 1 from Jul2020, and anxiety depressive disorder (she took a medication for that and it had been diagnosed more than ten years). Concomitant medication included bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE). The patient experienced facial droop (left eye and mouth) on 23Feb2021 14:30, tired and sore arm on an unspecified date. The clinical course was as following: She said her appointment for the vaccine was at 08:00AM, and around 02:30PM she was in a video meeting and her left side of her face started to droop and her coworker messaged her to ask if she was ok since she looked pretty funny with the eye and mouth droop. She said that this droop lasted about 4 hours and by 06:30PM it was mostly resolved, if she was not looking at it or trying to raise her eyebrows. She said that the only other side effects were she was tired and had a sore arm. She said doctor asked her to got to the emergency room (ER) to rule out a stroke or transient ischemic attack (TIA) so they did a couple of Computerised tomogram (CT) scans, one with contrast and one without, and a MRI and they did full blood lab work up, and did an Electrocardiogram (EKG) to rule out central nervous system events. She says that they didn't think it was a TIA, they felt it was a peripheral nervous event related to an autoimmune response and all the tests said that they did not thought she had TIA event. She said doctor said it was likely an auto immune response to receiving vaccine, since there were no intervening events between getting the vaccine and the droop, she has not been sick or had any dental events recently. the main reason she was calling was to see if she should get the second dose, since she wanted to get it but has heard the side effects can be stronger for the second dose. She says she would like to know can she or should she take it. The patient was tested was for a stroke but that test came back negative. The patient would like to know if it is contraindicated for her to receive the second dose after having this reaction. The outcome of the event Facial droop was recovering, and the outcome of the event tired and sore arm was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/23/2021,0.0,PVT,CONTRAVE,,Medical History/Concurrent Conditions: Anxiety depression (she took a medication for that and it had been diagnosed more than ten years); Diastolic dysfunction (diastolic dysfunction type 1); Sulfonamide allergy,,,"['Blood test', 'Computerised tomogram', 'Electrocardiogram', 'Facial paralysis', 'Fatigue', 'Magnetic resonance imaging', 'Pain in extremity']",1,PFIZER\BIONTECH, 1086895,CA,45.0,M,"Bell's palsy; This is a spontaneous report from a contactable consumer (patient's wife). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 02Feb2021 at 11:00 at a single dose on left arm for COVID-19 immunisation. Medical history included ongoing systemic lupus erythematosus (Lupus), ongoing hypertension (High Blood Pressure), ongoing gout and hip arthroplasty from Dec2020 to an unknown date; all diagnosed about 20 years ago. Concomitant medications included allopurinol, atorvastatin, benzonatate, chlorthalidone, apixaban (ELIQUIS), hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN), hydroxychloroquine, iron, loratadine, losartan potassium, mycophenolate mofetil, omeprazole, paricalcitol, prednisone, spironolactone and valacyclovir [valaciclovir] and vitamin D NOS. The reporter's husband had a reaction to the vaccine. She was wondering if it is ok to have the second dose. He got paralysis, Bell's Palsy on 14Feb2021. She clarified vaccine as COVID19 Vaccine. She would like any information available about second dose after having Bell's Palsy with the first dose. The outcome of the event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/14/2021,12.0,UNK,ALLOPURINOL; ATORVASTATIN; BENZONATATE; CHLORTHALIDONE; ELIQUIS; HYDROCODONE/ACETAMINOPHEN; HYDROXYCHLOROQUINE; IRON; LORATADINE; LOSARTAN POTASSIUM; MYCOPHENOLATE; OMEPRAZOLE; PARICALCITOL; PREDNISONE; SPIRONOLACTONE; VALACYCLOVIR [VALACIC,Gout (Verbatim: Gout/diagnosed about 20 years ago); Hypertension (Verbatim: High Blood Pressure/diagnosed about 20 years ago); Lupus syndrome (Verbatim: Lupus/diagnosed about 20 years ago),Medical History/Concurrent Conditions: Hip replacement (Verbatim: Hip replacement/diagnosed about 20 years ago),,,"[""Bell's palsy""]",1,PFIZER\BIONTECH, 1086896,NM,30.0,F,"syncopal episode; itching; fullness; feeling funny; This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), intramuscular on 19Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included manual vacuum aspiration (MVA), traumatic brain injury (TBI) from 2007 to an unknown date, vagovasal and hypotension post TBI, Celiac disease, allergy to milk products, diagnosed with COVID-19 from Aug2020 to an unknown date prior to vaccination. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medication included famotidine, methylphenidate, fludrocortisone, omeprazole, desvenlafaxine succinate (PRISTIQ), brexpiprazole (REXULTI), and folic acid. The patient was previously vaccinated with the first dose of bnt162b2 (lot number: EL3246) at the age of 30-year-old, intramuscularly for COVID-19 immunisation on 19Jan2021 at 14:15 and experienced heart flutters and ""fell faint"" (fainted). The patient also previously took ibuprofen and experienced allergies. After approximately 5 minutes after the patient had the second dose of vaccine (19Feb2021 14:20), the patient had syncopal episode, itching/ fullness. Covering physician present and assessed with EMS on Duty: VS: 110/80-BP, 18-RR, 96-HR, SaO2-98% on RA, CBG: 138. Patient awakened and reported ""feeling funny"" on 19Feb2021, but was A &Ox4, MAEW x4 with equal strength, Lungs Clear to auscultation. At 14:20 the patient was given Benadryl liquid PO given along with 8oz of water. Patient able to drink without issues. At 15:00, EMS called for ER transport to due prolonged recovery. The events resulted in emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,PUB,FAMOTIDINE; METHYLPHENIDATE; FLUDROCORTISONE; OMEPRAZOLE; PRISTIQ; REXULTI; FOLIC ACID,,Medical History/Concurrent Conditions: Celiac disease; COVID-19; Hypotension; Manual vacuum aspiration; Milk allergy; Traumatic brain injury; Vagal reaction,,,"['Abdominal distension', 'Auscultation', 'Blood glucose', 'Blood pressure measurement', 'Feeling abnormal', 'Heart rate', 'Oxygen saturation', 'Pruritus', 'Respiratory rate', 'Syncope']",2,PFIZER\BIONTECH,OT 1086897,NC,83.0,M,"severe allergic drainage from nasal cavity into chest; had pneumonia; collapse of the right middle lobe; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 30Jan2021 at 12:00 at a single dose on left arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and rosuvastatin. The patient developed shortness of breath and severe allergic drainage from nasal cavity into chest. Cough has ensued. Went to medical doctor (MD) today (13Feb2021 at 21:00) and received chest Xray and office said he had pneumonia with collapse of the right middle lobe. The patient underwent lab tests and procedures which included sars-cov-2 test: pending on 23Feb2021, heart rate: 78 and oxygen saturation (pulse oximeter registering): 91-94 on an unspecified date. The patient was prescribed with antibiotic pending result of COVID test. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/13/2021,14.0,PVT,ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ROSUVASTATIN,,,,,"['Atelectasis', 'Heart rate', 'Oxygen saturation', 'Pneumonia', 'Rhinitis allergic', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1086898,TN,52.0,F,"glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side; vaccines were given in the left arm because she was left-handed; Back pain; spasms; fever; she felt like the inside of her eyes were on fire; She had a moist cough; spine pain; nausea; vomiting; She had numbness and tingling around the outside of mouth; She had numbness and tingling around the outside of mouth; She had pain in the arm at the injection site; knees would buckle; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302) at single dose on 27Jan2021 via an unknown route in left arm for Covid-19 immunization. She was diagnosed diabetes six years ago (as of 23Feb2021), and her last A1C was 6.1 in Dec2020, had chronic edema since her last child was born 26 years ago. Concomitant drugs included furosemide (LASIX) 400 mg twice daily, potassium 10 meg three times daily, omeprazole (PRILOSEC) 40 mg once daily, and metformin hydrochloride (METFORMIN ER) 1000 mg twice daily, all ongoing. She did not feel like the medication she takes are relevant because she had been taking them for a very long time. Historical Vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140) intramuscular injection in left arm on 04Jan2021 for Covid-19 immunization and experienced back pain, diagnosed with COVID in between the first and second vaccine, headache, arm pain at the injection area, severe back spasms in the thoracic and lumbar (AER 2021200627). Patient experienced back pain 2-3 days after the first dose, headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given Voltaren and Flexeril. She was taking 1 gram of Tylenol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. The reporter assessed headache, arm pain at the injection area, back pain, severe back spasms in the thoracic and lumbar were related to suspect vaccine. After the 2nd dose of the vaccine, patient experienced back pain in Jan2021, sharp, stabbing, crushing pain and spasms in Jan2021, fever for a couple of days in Jan2021, knees would buckle in Jan2021, glands were swollen and when swallows, sharp pain on one side on 09Feb2021, felt like the inside of her eyes were on fire in Jan2021, moist cough in Jan2021, spine pain in Jan2021, nausea and vomiting in Jan2021, numbness and tingling around the outside of mouth in Jan2021, pain in the arm at the injection site in Jan2021, injection site was about a silver dollar size and was red and warm to touch in Jan2021. The event clinical course was as follows: The second dose was given on 27Jan2021. She was getting over COVID and had to wait until the 27Jan2021 to get second dose. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021 with results of her PCR test on 13Jan2021. She was diagnosed with COVID in between the first and second vaccine due to an exposure not the vaccine. At hour 25 after receiving the second dose symptoms started. Severe back pain in the entire spine. It was sharp, stabbing, crushing pain and spasms. When the back would spasm her knees would buckle. She had a fever for a couple of days. 102 fever and she felt like the inside of her eyes were on fire. She has never had that before. She had a moist cough and still has a moist cough. The spine pain was better, but it is not gone away yet. Normally she does not have back pain. At first the pain was an 8 out 10 now (as of 23Feb2021) it was 5 out of 10. Also had nausea and vomiting. She had numbness and tingling around the outside of mouth. That lasted for two days. She had pain in the arm at the injection site. The injection site was about a silver dollar size and was red and warm to touch. She had pain at the injection site and pain in the arm. Both vaccines were given in the left arm because she was left-handed. She thought she would be using that arm more. She did go to Urgent Care after the second dose as well. They gave her a shot of Toradol and another prescription for Voltaren twice a day and Flexeril at bedtime because she can't stay awake when she takes it. She has missed work because of this. The back pain and cough was almost a month now (as of 23Feb2021). She reported no matter what she did she did not get it to go away. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of Tylenol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She has been taking 1000mg Tylenol three times a day and now she was taking it two times a day. She used Tylenol and generic, SunMark Acetaminophen (Lot number: OLE2349B, expiry: Sep2022). Regarding seriousness of headache, made a different in the vision. It was throbbing. for back pain: it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor. for arm pain at the injection area: gripping was not easy and moving her arm was painful. She is left handed. Heat worked better than ice. Ice made things worse. for cough: it had not been disabling. it was irritating because it had been almost 30 days. She knows it was different than the COVID cough because it was moist and when she had COVID it was a dry cough. Regarding seriousness of nausea and vomiting: it was debilitating and she couldn't go anywhere because she was throwing up with every move she made. The pain made it worse. The reporter assessed moist cough, nausea and vomiting, arm pain at the injection area were related to suspect vaccine. No investigation assessment performed. Outcome of fever, inside of her eyes were on fire, pain in the arm at the injection site was resolved. Outcome of back pain, moist cough was not resolved. Outcome of spine pain was resolving. Outcome of the other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the back pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including spine CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/27/2021,01/01/2021,,UNK,LASIX [FUROSEMIDE]; POTASSIUM; PRILOSEC [OMEPRAZOLE]; METFORMIN ER,,"Medical History/Concurrent Conditions: Chronic edema (she has had chronic edema since her last child was born 26 years ago.); Diabetes (First dose, lot number: EL0140 ,intramuscular injection in left arm)",,,"['Back pain', 'Body temperature', 'Cough', 'Eye irritation', 'Glycosylated haemoglobin', 'Hypoaesthesia oral', 'Joint instability', 'Lymph node pain', 'Lymphadenopathy', 'Muscle spasms', 'Nausea', 'Pain assessment', 'Paraesthesia oral', 'Product use issue', 'Pyrexia', 'Spinal pain', 'Vaccination site erythema', 'Vaccination site oedema', 'Vaccination site pain', 'Vaccination site warmth', 'Vomiting']",2,PFIZER\BIONTECH, 1086899,MN,,U,"Maternal exposure during pregnancy; Preterm delivery at 24 2/7 weeks.; This is a spontaneous report from a contactable physician. This physician reported information for both mother and fetus/baby. This is a baby report. Only this case is serious. A 33-year-old female mother received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) on 28Jan2021 at single dose for Covid-19 immunization. The mother's medical history included obstructive sleep apnea, anxiety, and environmental allergies. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), calcium carbonate (TUMS), calcium chews, fluticasone propionate (FLONASE), and triamcinolone ointment. The mother had preterm delivery at 24 2/7 weeks on 20Feb2021 via emergency cesarean section. The last menstruation date was 09Sep2020. Gestational period was also reported as 22 weeks (pending clarification). The due date was reported as 10Jun2021. The fetus experienced maternal exposure during pregnancy via transplacental route on an unspecified date. The events resulted in emergency room/department or urgent care and hospitalization for 2 days. The mother had nasal swab COVID test on 20Feb2021 with negative result. The outcome of the events was recovered. Information about lot/batch number has been requested.; Sender's Comments: Pending the clinical course of pregnancy and risk factors for premature delivery, the company considered there is not a reasonable possibility that the event premature baby was related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021199045 maternal case",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,01/28/2021,02/20/2021,23.0,UNK,PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; TUMS [CALCIUM CARBONATE]; CALCIUM; FLONASE [FLUTICASONE PROPIONATE]; TRIAMCINOLONE,,,,,"['Maternal exposure during pregnancy', 'Premature baby']",UNK,PFIZER\BIONTECH,OT 1086900,VA,59.0,F,"having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; Headache; having issues with her right hand being numb/1st 2 fingers on her right hand were numb; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 01Mar2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200, expiry date was not reported) (at 59 years of age), via an unspecified route of administration in the right arm on 20Feb2021 15:49 at a single dose for COVID-19 immunisation. The patient's medical history and family medical history were none. The concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, 1st dose, lot number: EL9263, injection in right arm on 30Jan2021 (at 59 years of age). There was no other vaccines administered on same date with the Pfizer vaccine and there was no any other vaccinations within four weeks prior to the first administration date of the vaccine. The patient stated that she is not an HCP, but she does work in a mental health. She stated that she is concerned. She got her 2nd dose of the vaccine on Saturday and was having weakness in her right hand and arm. She asked if this was expected. She added that when she got up yesterday, her right arm was really sore, she was extremely tired, and she had a headache. She went to bed early that night at around 5:30pm, and she woke up around 8 or 9pm that night and tried to pick up her phone and couldn't. She stated that the 1st 2 fingers on her right hand were numb. When she got up today it was fine. They are working from home, so she was typing some notes and then it felt like her fingers went numb, it felt like her 1st finger was like rubber. She stated that the numbness comes and goes. She mentioned that she doesn't have a headache right now, but it felt like it could come back. The events did not require emergency room or physician visit. On 01Mar2021, it was reported that the patient was having issues with her right hand being numb and the representative that she spoke with recommended she follow up with her PCP, which she did, and they diagnosed her with having a small stroke and also referred her to a neurologist as well. She said that her primary care provider she saw was a nurse practitioner. She said that she also saw a neurologist. It was not reported if the patient received treatment for 'having a small stroke' while no treatment received for all other events. The outcome of having a small stroke was unknown; 'weakness in her right hand and arm' was not recovered; while 'Right arm was really sore' and 'really tired' was recovering. The outcome of Headache and 'having issues with her right hand being numb/1st 2 fingers on her right hand were numb' was recovered on an unknown date.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/21/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Cerebrovascular accident', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Muscular weakness', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1086901,DE,75.0,M,"His oxygen dropped too low to 76; Pneumonia; something with toxins; he couldn't eat or swallow; he couldn't eat or swallow; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is the 1st of 2 reports. This consumer (wife) reported for a 75-year-old male patient that received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 31Jan2021 (at the age of 75-years-old) for COVID-19 immunization. Medical history included dialysis for approximately 2.5 years, a lung problem, blood pressure. Concomitant medications included carvedilol and warfarin and other unspecified medications. The patient experienced pneumonia and died on 11Feb2021 03:00 AM. An autopsy was not performed. The cause of death was reported to be pneumonia. Clinical course was the follows the next day on 01Feb2021 at 9:30AM the patient was dressed and ready to go to dialysis. His oxygen dropped too low to 76. He wanted an ambulance called. He went into the hospital. The patient was confused, and he was not normally confused. In the hospital the physicians said he had pneumonia, but it wasn't that bad. The doctors were baffled. He also was in the hospital for something with toxins. He had a lung problem for a long time. If he didn't go to the bathroom the toxins were hitting the liver and then the toxins were going to the brain. When he was in the hospital he couldn't eat or swallow. The first day he did eat a bit, but he had dialysis in the hospital, and it knocks him out. They were giving him antibiotics IV. He couldn't swallow any of his pills. He was in there for 11 days and had not eaten. He couldn't swallow any pills. He started going to sleep and they started giving him Morphine drip at the end. They couldn't get any medicine in him because he couldn't swallow. The patient died of pneumonia, the outcome of the other adverse events was unknown. Information on lot number/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021247875 Same report, different patient/event; Reported Cause(s) of Death: Pneumonia",Yes,02/11/2021,Not Reported,Yes,,Not Reported,N,01/31/2021,02/01/2021,1.0,UNK,CARVEDILOL; WARFARIN,,Medical History/Concurrent Conditions: Blood pressure (He was on Carvedilol from the heart doctor. That could have been for blood pressure); Dialysis (He had been doing dialysis for approximately 2.5 years); Lung disorder,,,"['Dysphagia', 'Eating disorder', 'Oxygen saturation', 'Oxygen saturation decreased', 'Pneumonia', 'Toxicity to various agents']",1,PFIZER\BIONTECH, 1086916,PR,56.0,F,"Lymphadenopathy in the glands of the armpit were the first and second shot were given; Strong headache; Mild tiredness; chills; low fever; This is a spontaneous report from a contactable Consumer. A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 (Lot Number: EW 5318) via an unspecified route of administration at SINGLE DOSE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL 3248) on 13Jan2021 without expected adverse event (arm pain and tiredness). The patient had lymphadenopathy in the glands of the armpit were the first and second shot were given on 05Feb2021. Strong headache (not improving with Acetaminophen 500 mg on 04Feb2021, Mild tiredness, chills and low fever on 03Feb2021. The patient started Tylenol for the common symptoms expected after the shot that day (as recommended by the vaccination center). Tiredness started that day. The strong headache started late afternoon of 04Feb2021 (less than 24 hrs. from reporting). On 05Feb2021 around 8:00 the armpit swollen. There was not a sudden but a progression of symptoms. The patient didn't report the events aware that are common from vaccination, and reported (1 hour, 25 minutes) about the armpit swollen. The patient stated that the tiredness was indicated as a common effect so not report it Tylenol was recommended. The strong headache started late on 04Feb2021 and the armpit swollen the day after 05Feb2021 (Early in the morning). The patient took rest on the weekend and changed from Tylenol to Naproxen. Headache and swollen armpit (left side where the shot was given) disappeared. Feeling well since yesterday (currently without medication). The outcome of the event strong headache and Lymphadenopathy in the glands of the armpit were the first and second shot were given was recovered and outcome of all other events was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/03/2021,0.0,UNK,,,,,,"['Chills', 'Fatigue', 'Headache', 'Lymphadenopathy', 'Pyrexia']",2,PFIZER\BIONTECH, 1086926,,,M,"thought that it might be a stroke; Lip is dripping at the right side; A spontaneous report was received from a Healthcare professional which concerns 37-year-old male nurse patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced a situation where his right lip is dripping and thought that it might be a stroke. The patient's medical history was not provided. The concomitant medication included Tizanidine. On 23-Dec-2021, approximately 27 days prior to the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly for prophylaxis of COVID-19 infection. On 18-Jan-2021, Patient experienced a situation where his right lip are is dripping and thought that it might be a stroke. Treatment information was not provided. Action taken with mrna-1273 in response to the events was unknown. The outcome of the event(s) where his right lip is dripping and thought that it might be a stroke was unknown.; Reporter's Comments: Limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/23/2020,01/18/2021,26.0,UNK,TIZANIDINE,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Drooling', 'Pseudostroke']",1,MODERNA, 1086927,WA,69.0,F,"Difficulty Breathing; Chest Tightness; allergic reaction; A spontaneous report was received from a Healthcare Professional concerning a 69-years-old female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced events difficulty breathing and chest tightness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 29 Jan 2021, immediately after the first dose, the patient experienced the events difficulty breathing and chest tightness. Treatment details included, Benadryl - Given by the ER HCP to alleviate the allergic reaction to the Moderna COVID-19, Vaccine. The events of difficulty breathing and chest tightness were considered to be serious with criteria of life threatening. Action taken with mRNA-1273 in response to the events was unknown. On 29 Jan 2021 the outcome of events difficulty breathing and chest tightness was resolved.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/29/2021,01/29/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Chest discomfort', 'Dyspnoea', 'Hypersensitivity']",1,MODERNA,OT 1086928,CA,50.0,F,"Chose not to get second shot; Deep Vein Thrombosis; A spontaneous report was received from a consumer, concerning a 50 year-old, female who received Moderna (mRNA-1273) and developed deep vein thrombosis, and chose not to get second shot. The patient's medical history was not provided. Concomitant product was not provided. On 07Jan2021 (previously reported as 16Jan2021), approximately one week prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (batch number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection. A week post vaccination, she had a thick painful cord down injection arm and was misdiagnosed with tendonitis. After a second opinion, she was diagnosed with deep vein thrombosis. On 01FEB2021, an ultrasound confirmed a blood clot and subsequently, she went to the ER. A computerized tomography (CT) of the lungs ruled out pulmonary embolism. Based on these events, the patient chose not to get the second shot. Treatment included rivaroxaban and follow-up with hematologist. The second dose of mRNA-1273 was discontinued in response to the event. The outcome of the events deep vein thrombosis and chose not to get second shot were unknown. Follow-up information received 08Feb2021 included additional event, date of first dose was updated from 16Jan2021 to 07Jan2021, diagnostic test and treatment.; Reporter's Comments: This case concerns a 50 year-old, female who experienced deep vein thrombosis. Treatment included rivaroxaban and follow-up with hematologist.Very limited information regarding this event has been provided at this time. Further information has been requested. The causality for the event of intentional dose omission is assessed to be not applicable.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/16/2021,02/01/2021,16.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Computerised tomogram', 'Deep vein thrombosis', 'Intentional dose omission', 'Ultrasound scan']",1,MODERNA, 1086929,TX,85.0,M,"Seizure; A Spontaneous report was received from a consumer concerning a 85-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed seizure. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 23 Feb 2021, two hours prior to the onset of the event seizure, the patient received their second of two planned doses of mRNA-1273 (Lot 030M20A) intramuscularly for prophylaxis of COVID-19 infection. On 23 Feb 2021, 2 hours post vaccination the patient developed medically significant event of seizure. Treatment for the event included lorazepam. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event seizure was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,02/23/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Seizure'],1,MODERNA,OT 1086930,WV,,F,"gradual decline in her abilities both mental and physical; gradual decline in her abilities both mental and physical; tremors; could no longer walk; lost use of right arm; hallucinating; fallen and could not get up; A spontaneous report was received from a consumer concerning a 88-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced a fall, a gradual decline in her abilities both mental and physical, hallucinating, having tremors, could no longer walk and has lost the use of her right arm. The patient's medical history was not provided by the reporter. Concomitant medicines were not reported. On 19-Feb-2021, approximately one day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 30M20A) in the right arm for prophylaxis of COVID-19 infection. On Saturday 20-Feb-21, it was reported that the patient had fallen and could not get up. On Sunday 21-Feb-21, per report, the patient had a noted decline in her mental and physical abilities, was hallucinating, having tremors, difficulty walking and had lost the use of her right arm. The patient was transported to the hospital via ambulance and admitted. The computed tomography scan was negative. Testing for urinary tract infection was negative as well. The patient received both scheduled dose of mRNA-1273, therefore, action taken with the drug in response to the events was not applicable. The outcomes of the events, a fall, a gradual decline in her abilities both mental and physical, hallucinating, having tremors, could no longer walk and has lost the use of her right arm, were considered unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/19/2021,02/20/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Computerised tomogram', 'Fall', 'Gait inability', 'Hallucination', 'Mental impairment', 'Monoplegia', 'Physical deconditioning', 'Tremor', 'Urinary tract infection']",2,MODERNA,OT 1086931,MA,75.0,F,"Shingles in the ear; Passed out; Couldn't mover her arm, head, legs, chest, felt paralyzed; Felt weak; A spontaneous report was received from a consumer concerning a female patient of 75 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced loss of consciousness, paralysis, weakness and shingles in the ear. The patients medical history, as provided by the reporter, included myasthenia gravis. Concomitant medications reported included lidocaine patch and prednisone. On 10 feb 2021,prior to the onset of events, the patient received their first of two planned dose of mRNA-1273(Lot number:010M20A ) intramuscularly on an unknown arm for prophylaxis of COVID-19 infection. On 11 feb 2021, one day after vaccination,patient experienced loss of consciousness,paralysis and weakness. The event loss of consciousness and paralysis was also considered to be medically significant. On 16 feb 2021, patient experienced shingles in the ear. Treatment for the events included acyclovir and ice. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the events loss of consciousness, paralysis, weakness and shingles in the ear were considered as unknown.; Reporter's Comments: Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,02/11/2021,1.0,UNK,ASPERCREME LIDOCAINE PATCH; PREDNISONE,,Medical History/Concurrent Conditions: Myasthenia gravis,,,"['Asthenia', 'Herpes zoster', 'Loss of consciousness', 'Paralysis']",1,MODERNA,OT 1086932,FL,,F,"swollen lymph nodes; (DCIS)Ductal Carcinoma In Situations and Causes; A spontaneous report was received from an consumer concerning a female patient (unspecified age) who experienced Ductal Carcinoma In Situations and Causes and swollen lymph nodes. The patient's medical history included hypertension and cholesterol since an unknown date. Concomitant product use was not provided by the reporter. On 23 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On date 26 Jan 2021 the patient was diagnosed with (DCIS) Ductal Carcinoma In Situations and Causes at stage o grade and on date 14 Feb 2021 Patient experienced swollen lymph nodes. The event Ductal Carcinoma In Situations and Causes was considered medically significant. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The events, ductal carcinoma in situations and causes and swollen lymph nodes were unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/23/2021,01/26/2021,3.0,UNK,,Cholesterol; Hypertension,,,,"['Biopsy', 'Intraductal proliferative breast lesion', 'Lymphadenopathy']",1,MODERNA,OT 1086933,WA,96.0,F,"Pneumonia; Unresponsive at times; Weak; Diarrhea; Feeling Punky; Body aches/muscle aches; Fever; Chills; Nausea; Vomiting; Sore arm at site of injection; A spontaneous report, was received from a nurse (caregiver), regarding a 96 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced pneumonia, unresponsive at times (unresponsive to stimuli), weak (asthenia), diarrhea, feeling punky (malaise), body aches/muscle aches (myalgia), fever (pyrexia), chills, nausea, vomiting, sore arm at site of injection (vaccination site pain), and vomiting. The patient's medical history was not reported. Historical vaccine reported was flu shot. Concomitant medications included insulin, unspecified medication for pulmonary hypertension and heart failure. On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A), intramuscular for the prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient experienced the sore arm. On 07 Feb 2021, the patient experienced body aches, sore arms, felt punky, weak, fevers with a body temperature of 103.7 (unknown units), chills, nausea, vomiting, diarrhea and muscle aches. Treatment medication included acetaminophen. On 08 Feb 2021, the patient continued with high fever, unresponsive at times, and all other symptoms. On 09 Feb 2021, the patient's fever was control, very weak and passed away on the same day at 04 45 pm. The death occurred and death certificate stated that pneumonia was the cause of death. Action taken with second dose of mRNA-1273 in response to the events was not applicable. The outcome of the event, pneumonia was considered as fatal, and that of other events unresponsive at times, weak, diarrhea, feeling punky, body aches/muscle aches, fever, chills, nausea, vomiting, sore arm at site of injection, and vomiting were considered as unknown. The patient died on 09 Feb 2021. Plans for an autopsy was unknown. The cause of death was reported as pneumonia.; Reporter's Comments: This case concerns a 96 year old, female patient, who experienced a serious unexpected event of Pneumonia (fatal) among others, 5 days after receiving 1st dose of mRNA- 1273 (Lot# 013M20A). Very limited information regarding these events has been provided at this time. The subject's con meds included insulin, unknown medications for pulmonary HTN and heart failure. The cause of death was determined to be pneumonia. Advanced age and co-morbidities may remain as risk factors.; Reported Cause(s) of Death: Pneumonia",Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,UNK,INSULIN,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Asthenia', 'Body temperature', 'Chills', 'Diarrhoea', 'Feeling abnormal', 'Myalgia', 'Nausea', 'Pneumonia', 'Pyrexia', 'Unresponsive to stimuli', 'Vaccination site pain', 'Vomiting']",1,MODERNA,OT 1086934,FL,83.0,F,"headache; tiredness; muscle pain; fever; nausea; feeling unwell; Injection site pain; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/lot number: EL9262;) via an unspecified route of administration on 26Jan2021 at single dose for covid-19 immunisation. Medical history included parkinson's disease ongoing. Concomitant medication included carbidopa monohydrate, levodopa (CARBIDOPA + LEVODOPA) for Parkinsons disease, clonazepam. The patient previously received first single dose of bnt162b2 for Covid-19 immunization (she had no side effects after the first dose of the vaccine). Patient had Parkinsons disease received the second dose of the Pfizer COVID-19 vaccine yesterday, 26Jan2021, and today she was experiencing most of the symptoms listed including: injection site pain in Jan2021, on 26Jan2021, had tiredness, headache (Had a headache, headache for the most part gone but still lingering), muscles pain, fever, nausea and feeling unwell. The caller states that she had no side effects after the first dose of the vaccine. The caller wants to know how long her symptoms are going to last. The outcome of the event Injection site pain was unknown, rest of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/01/2021,,UNK,CARBIDOPA + LEVODOPA; CLONAZEPAM,Parkinson's disease,,,,"['Fatigue', 'Headache', 'Malaise', 'Myalgia', 'Nausea', 'Pyrexia', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1086935,TN,44.0,F,"lymph node under my left arm, close to my left breast is swollen; it is sore; felt chills; injections site pain; tiredness; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 11:15 (Lot number: EN5318) via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included high blood pressure from an unknown and unknown if ongoing. Concomitant medications included lisinopril, amlodipine, metoprolol and levocabastine hydrochloride (Zyrtec). The patient had no allergies to medications, food or other products. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that the lymph node under his left arm, close to his left breast was swollen. The patient also felt chills, injections site pain, and tiredness on 27Jan2021 04:00. The events assessed as non-serious by the reporter. It was unknown if the patient received treatment. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,01/27/2021,1.0,UNK,LISINOPRIL; AMLODIPINE; METOPROLOL; ZYRTEC [LEVOCABASTINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Blood pressure high,,,"['Chills', 'Fatigue', 'Lymph node pain', 'Lymphadenopathy', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1086936,,,F,"arm hurt; felt headache; uncontrollable chills; absolute exhaustion; nausea; fever; not able to sleep; This is a spontaneous report from a contactable consumer (patient). A 57-(unit: unknown)-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 18Jan2021 at single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller (patient) wanted to know if side effects to the Pfizer covid vaccine have been reported outside of 12-36 hours post-vaccine. The patient received the Pfizer covid vaccine on 18Jan2021, her arm hurt on the next day (19Jan2021), but on the Friday in Jan2021 she felt headache, uncontrollable chills, absolute exhaustion although not able to sleep, nausea and fever. She went to get tested for the virus twice since then, on 25Jan2021 and 27Jan2021 but was negative both times. She has never called off work before and has had to 'take a few days' because of the side effects. Caller would like to know if her side effects will be worse after the second dose of the covid vaccine. The events outcome was unknown. Information regarding lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,01/01/2021,,UNK,,,,,,"['Chills', 'Fatigue', 'Headache', 'Insomnia', 'Nausea', 'Pain in extremity', 'Pyrexia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1086937,CT,26.0,F,"Extreme arm soreness which is getting progressively worse; making it difficult to lift or move the arm entirely; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 29Jan2021 10:30 (at the age of 26-years-old) as a single dose for covid-19 immunisation. The patient medical history was not reported. It was unknown if patient had any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included gabapentin (MANUFACTUTERE UNKNOWN), fish oil (MANUFACTUTERE UNKNOWN), ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 13:00, the patient experienced extreme arm soreness which is getting progressively worse and making it difficult to lift or move the arm entirely. Seriousness criteria was considered as non-serious. The patient did not receive any treatment for the events. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/29/2021,0.0,WRK,GABAPENTIN; FISH OIL; MULTIVITAMIN ACTIVE WOMAN,,,,,"['Mobility decreased', 'Pain in extremity']",1,PFIZER\BIONTECH, 1086938,MO,44.0,M,"sore arm; restlessness; Body aches; chills; fatigue; Swollen lymph node under left clavicle; This is a spontaneous report from a contactable consumer (reported for himself). A 44-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: 9262), on Left Arm via an unspecified route of administration on 26Jan2021 13:30 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot no: 3248) on left arm on 07Jan2021 12:00 PM for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 10:00 PM No symptoms besides a sore arm and restlessness for first 12 hours. Body aches, chills, fatigue for following 24 hours. Fatigue for an additional 24 hours. Swollen lymph node under left clavicle starting at 36 hours and still present. Outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/01/2021,,PUB,,,,,,"['Chills', 'Fatigue', 'Lymphadenopathy', 'Pain', 'Pain in extremity', 'Restlessness']",2,PFIZER\BIONTECH, 1086939,TX,68.0,F,"A rash 5"" x 7"" on my back, rash on neck; spots on various parts of the body; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 68-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ENS318, Expiry date: unknown), via an unspecified route of administration on 28Jan2021 at 08:30 am (age at the time of vaccination was 68-years-old) on left arm at single dose for covid-19 immunisation. Medical history included hypothryoidism, high blood pressure, C-Diff. The patient did not have allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID), lisinopril, desvenlafaxine, solifenacin. The patient A rash 5"" x 7"" on my back, rash on neck, and spots on various parts of the body on 29Jan2021 at 07:00 am. The adverse event result in Emergency room/department or urgent care. The event was considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received Decadron IM 10 mg shot & Medrol 4 mg tab as treatment for the events. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,PVT,SYNTHROID; LISINOPRIL; DESVENLAFAXINE; SOLIFENACIN,,Medical History/Concurrent Conditions: Blood pressure high; Clostridium difficile infection; Hypothyroidism,,,"['Rash', 'Rash macular']",1,PFIZER\BIONTECH, 1086940,FL,,M,"he received series of vaccine and antibody testing negative; This is a spontaneous report from a contactable pharmacist (patient). A male patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, on an unknown date at a single dose for COVID-19 immunisation. The relevant medical history was not reported. The concomitant medication included azathioprine sodium (IMURAN) and eculizumab (SOLIRIS). The patient underwent antibody testing which was negative on an unknown date. It was also reported that patient was asking for information on testing and those immunosuppressed (as reported) since patient was taking IMURAN and SOLIRIS. The outcome of the event was unknown. Information on the lot/batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,IMURAN [AZATHIOPRINE SODIUM]; SOLIRIS,,,,,"['SARS-CoV-2 antibody test', 'SARS-CoV-2 antibody test negative']",UNK,PFIZER\BIONTECH, 1086941,TX,49.0,F,"right arm was feverish, painful and difficult to move; right arm was feverish, painful and difficult to move; right arm was feverish, painful and difficult to move; fatigued; developed a fever/reached 101.3 and was steady at 100 F for the duration of day/fever broke; piercing headache; sleepiness; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 49-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262, Expiry date: unknown), via an unspecified route of administration on 30Jan2021 at 09:15 am (Age at the time of vaccination was 49-years-old) at single dose on right arm for covid-19 immunisation. Medical history included hypertension an obesity. The patient did not have allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included propranolol, triamterene, bupropion, valaciclovir hydrochloride. The patient reported that, within 4 hours of injection, on 31Jan2021 at 08:00 my right arm was feverish, painful and difficult to move. Within 8 hours, I became fatigued and developed a fever the next day at 8 am that reached 101.3 and was steady at 100 F for the duration of day. I also developed a piercing headache and sleepiness. At 1:45 am on 02Feb2021, my fever broke. My headache remained until 02Feb2021. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The patient recovered from the event headache on 02Feb2021 and recovered from other events on an unspecified date in 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/30/2021,01/31/2021,1.0,UNK,PROPRANOLOL; TRIAMTERENE; BUPROPION; VALACYCLOVIR HCL,,Medical History/Concurrent Conditions: Hypertension; Obesity,,,"['Body temperature', 'Fatigue', 'Headache', 'Pyrexia', 'Somnolence', 'Vaccination site movement impairment', 'Vaccination site pain', 'Vaccination site warmth']",1,PFIZER\BIONTECH, 1086942,FL,38.0,F,"symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; This is a spontaneous report from a contactable Other HCP. A 38-year-old non-pregnant female received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 (Lot number: EL3302) via intramuscular route of administration at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included environmental allergies, Type 2 diabetes mellitus, Mixed hyperlipidemia, Attention deficit hyperactivity disorder, Obesity and Anxiety from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin calcium at 20mg, Desogestrel/Ethinylestradiol (Azurette) at (23) 0.15mg-0.02mg (21)/0.07mg (S), clotrimazole and betamethasone at 1%-5%, cyclobenzaprine at 10mg, escitalopram oxalate (lexapro) at 20mg, metformin at 500mg, esomeprazole magnesium (nexium) at 20mg, montelukast sodium (singulair) at 10mg, amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (Adderall) at 20 mg, cetirizine hydrochloride (zyrtec) at 10 mg, fluticasone proplonate at 50mcg. It was unknown if the patient had illnesses at the time of vaccination and up to one month prior. Patient was seen in office on 27Jan2021 and reported symptoms of Headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors causing change in handwriting for the past 1.5 to 2 weeks after receiving vaccination. Upon review of Neurological symptom, patient was positive for loss of balance and coordination 4/5 strength. In all extremities, and 4/5 grip strength, CT of Head with and W/O contrast was ordered. CBC, CMP, free T4, HgbA1c, lipid, 'TSH, Urinalysis, Vitamin B12, Folate and CK laboratory ordered. CT Head with and w/o Contrast on 27Jan2021 showed no acute intracranial process Identified. No evidence of enhancing lesion. Patient had not completed laboratory at this time. It was unknown if the patient had doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/13/2021,0.0,PVT,ATORVASTATIN CALCIUM; AZURETTE; CLOTRIMAZOLE AND BETAMETHASONE; CYCLOBENZAPRINE; LEXAPRO; METFORMIN; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; SINGULAIR; ADDERALL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLUTICASONE PROPIONATE,,Medical History/Concurrent Conditions: Anxiety; Environmental allergy; Hyperactivity; Mixed hyperlipidemia; Obesity; Type 2 diabetes mellitus,,,"['Amnesia', 'Balance disorder', 'Balance test', 'Blood creatine phosphokinase', 'Blood folate', 'Blood thyroid stimulating hormone', 'Computerised tomogram', 'Dizziness', 'Full blood count', 'Glycosylated haemoglobin', 'Grip strength', 'Headache', 'Lipids', 'Metabolic function test', 'Speech disorder', 'Thyroxine free', 'Tremor', 'Urine analysis', 'Vitamin B12']",UNK,PFIZER\BIONTECH,OT 1086943,WA,73.0,F,"Injection site is red, itchy and slightly raised.; Injection site is red, itchy and slightly raised.; This is a spontaneous report from a contactable consumer (patient, self-reported). A 73-year-old female patient received (who was not pregnant, at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL3302 and expiry date was unknown) via an unspecified route of administration, in Arm Left, on 26Jan2021 15:00, as single dose for COVID-19 immunization, at hospital. Patient's medical history was not reported. Concomitant medications were included women's Multi-Vitamin, Calcium and Fish Oil (within two weeks of vaccination). Patient previously took sertraline and citalopram; had allergies with these two medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, Prior to vaccination. Since the vaccination, Patient has not been tested for COVID-19. On 02Feb2021, 23:00, patient experienced Injection site is red, itchy and slightly raised. Patient was not received treatment for the events. Seriousness of the events was reported as non-serious. Outcome of the events was reported as not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,02/02/2021,7.0,PVT,CALCIUM; FISH OIL,,,,,"['Vaccination site erythema', 'Vaccination site pruritus']",1,PFIZER\BIONTECH, 1086944,UT,35.0,M,"nausea; weakness; fever; photophobia; body aches; night sweats; chills; headache; arm pain; This is a spontaneous report from a contactable Pharmacist (Patient). A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: EL3246) via intramuscular in the left arm on 13Jan2021, at 12:30 (at the age of 35-year-old) as a single dose for COVID-19 immunization. The patient medical history included ulcerative colitis, adhd (Attention deficit hyperactivity disorder), prediabetes, high cholesterol. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medication included mesalazine (LIALDA), methylphenidate hydrochloride (CONCERTA), cetirizine hydrochloride (ZYRTEC), vitamin d, citalopram and atorvastatin. The patient previously took historical vaccine first dose of bnt162b2 (Lot number: EK5730), via intramuscular, on left arm on 22Dec2020, at 16:30 (at the age of 35-year-old) for COVID-19 immunization and experienced arm pain. On 13Jan2021, the patient experienced arm pain at 13:30 and, headache at 14:30. On 14Jan2021, at 00:30 body aches, night sweats, chills and at 12:30 patient had fever and photophobia. On 15Jan2021, at 12:30 the patient had weakness. On 16Jan2021 at 12:30 the patient had nausea. The patient did not receive any treatment for the events. The outcome of the events was reported as non-serious. The outcome for all the events was recovered on an unknown date in 2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,PVT,LIALDA; CONCERTA; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN D [VITAMIN D NOS]; CITALOPRAM; ATORVASTATIN,,Medical History/Concurrent Conditions: ADHD; High cholesterol; Prediabetes; Ulcerative colitis,,,"['Asthenia', 'Chills', 'Headache', 'Nausea', 'Night sweats', 'Pain', 'Pain in extremity', 'Photophobia', 'Pyrexia']",2,PFIZER\BIONTECH,OT 1086945,GA,25.0,F,"Sore arm; This is a spontaneous report received from a contactable consumer (herself). A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3302) via an unspecified route of administration on 2Feb2021 16:00 to Left arm at single dose for COVID-19 immunization. Medical history included Depression, High Cholesterol, Asthma and High b/p. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) at 88ug and metformin at 500 mg twice a day. It was reported as on 02Feb2021 patient experienced with Sore arm day after injection. Seriousness was reported as non-serious and patient did not receive any treatment for the event. No follow-up attempts are possible. No further information was provided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,UNK,LEVOTHYROXIN; METFORMIN,,Medical History/Concurrent Conditions: Asthma; Blood pressure high; Depression; High cholesterol,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1086946,,,F,"One of my fillings came out yesterday so, I have a dental appointment; This is a spontaneous report received from a contactable consumer (patient herself). An unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route if administration on 30Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure and knee replacement in 2014. Concomitant medications were not reported. Patient received her first shot of the Pfizer COVID vaccine 30Jan2021. Yesterday on 03Feb2021 her crown fell out. Today, 04Feb2021 she is going in for a dental appointment to get it taken care of. She is required to take antibiotics and Novocaine for the procedure later today. She mentioned history of taking blood pressure medication and a knee replacement in 2014. Second dose of the Pfizer vaccine is scheduled 20Feb2021. Patient stated that one of her fillings came out yesterday, so she has a dental appointment. Outcome of event was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,02/03/2021,4.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure (Caller also mentions a history of taking blood pressure medication and a knee replacement in 2014); Knee replacement (Caller also mentions a history of taking blood pressure medication and a knee replacement in 2014),,,['Dental discomfort'],1,PFIZER\BIONTECH, 1086947,OR,78.0,M,"diarrhea which persisted for more than four days with liquid or very loose stools; Five or more bowel movements/day with considerable gas; This is a spontaneous report from a contactable consumer reported that a 78-year-old female patient (consumer) received first dose BNT162B2 (COVID 19, brand: Pfizer, Solution for injection, lot number: EN5318) via an unspecified route of administration on 28Jan2021 at 15:30 on Left arm for covid-19 immunization. Patient medical history included Type II diabetes, heart problems, bypass surgery in Sep2019. Concomitant medications were not reported. It was reported that, three days after receiving the injection, on 31Jan2021 she developed diarrhea which persisted for more than four days with liquid or very loose stools. Five or more bowel movements/day with considerable gas. No fever, aches. No urge for bowel movement when there was nothing to evacuate. Age at vaccination was 78 Years. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. No seriousness criteria was reported. Outcome of events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/31/2021,3.0,UNK,,,Medical History/Concurrent Conditions: Bypass surgery; Heart disorder (heart problems); Type II diabetes mellitus (Type II diabetes),,,"['Diarrhoea', 'Frequent bowel movements']",1,PFIZER\BIONTECH, 1086948,MN,,F,"some loose bowel movements; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Not Provided, NDC number of Pfizer COVID vaccine: Not Provided, Expiry Date of Pfizer COVID vaccine: Not Provided), via an unspecified route of administration on 04Feb2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The caller (patient) mentioned that ""she got her first dose of the covid 19 vaccine today. She says that she had some loose bowel movements on Feb2021 and she would like to know if that is normal. She asked also what would happen if someone got a vaccine that was not kept in refrigeration since she lives in a little town and she does not know if they have the conditions to keep the vaccines in the right refrigeration."" Caller wanted to know how long the side effect will last. On 04Feb2021 following details were provide: Unspecified if Pfizer COVID vaccine a Pfizer product; Unspecified if Pfizer COVID vaccine manufacturer. Reason for no lot number of Pfizer COVID vaccine reported as caller unwilling to complete the report. Investigation Assessment was not provided. The patient experienced some loose bowel movements on Feb2021. The outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/01/2021,,UNK,,,,,,['Diarrhoea'],1,PFIZER\BIONTECH, 1086949,SC,58.0,F,"Fever of 102.5 degrees lasting about 30 hrs; joint pain; Headache; This is a spontaneous report from a contactable other health professional. A 58-year-old female patient received BNT162B2, (Solution for injection, Batch/Lot: EL3249), in right arm via intramuscular on 02Feb2021 10:30 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included allergies. The patient's concomitant medications was not reported. Historical vaccine of BNT162B2 on 12Jan2021 for COVID-19 immunization, lot number: EK9231, administration time: 10:45 AM, route: Intramuscular, vaccine location: Right arm, dose number: one. The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products was yes. The patient had event fever of 102.5 degrees lasting about 30 hrs, joint pain, headache on 02Feb2021 at 08:45 PM. The treatment was not received for the adverse events. The patient underwent lab tests and procedures which included body temperature: 102.5 degrees. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/02/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Allergy (known_allergies Yes),,,"['Arthralgia', 'Body temperature', 'Headache', 'Pyrexia']",2,PFIZER\BIONTECH,OT 1086950,NJ,,F,"Hives; Rash/rash...spotty kind of thing/rash was mostly across her abdomen and back; Itching/It was itchy nut not horrible on her wrist, elbow/her elbows, wrists, and ankles would itch sometimes; Headache; Muscle aches in her arms and legs; Twitching in her thigh; Muscle cramping; This is a spontaneous report from contactable other HCP (patient). A female patient of an unspecified age received bnt162b2 (Solution for injection) , via an unspecified route of administration from 21Jan2021 at single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. She had her 1st dose of the vaccine on 21Jan2021, and had on 21Jan2021 hives hours later and a rash on and off for a few days. States that the rash was mostly across her abdomen and back, but her elbows, wrists, and ankles would itch sometimes. In Jan2021, She also has had headaches, muscle aches in her arms and legs, and twitching in her thigh, which she still has. Caller states that she has read the literature, and it's not clear if she is or is not a candidate for the 2nd shot. States that she could ask her doctor, but her doctor will just refer her to the literature. Caller received the covid vaccine on Thursday 21Jan2021, a few hours later though, she developed a rash, spotty kind of thing, on and off. She took some Benadryl. In Jan2021, It was itchy nut not horrible on her wrist, elbow. Also, she experienced muscle cramping, headache and 'all that stuff. The outcome of event Twitching in her thigh was not recovered and other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/01/2021,,UNK,,,,,,"['Headache', 'Muscle spasms', 'Muscle twitching', 'Myalgia', 'Pruritus', 'Rash', 'Urticaria']",1,PFIZER\BIONTECH, 1086951,KY,33.0,M,"Injection site soreness; enlarged, painful lymph nodes in left arm pit; enlarged, painful lymph nodes in left arm pit; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EM9810), via an unspecified route of administration at Arm Left on 04Feb2021 17:00 at the 33 years old at single dose for COVID-19 immunization. The medical history was none. The Known allergies was None. The concomitant medication was hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ). The Historical Vaccine was first dose BNT162B2(lot number EL3249) on 15Jan2021 07:00 at 33-year-old at Left arm for COVID-19 immunization. The patient experienced Injection site soreness and enlarged, painful lymph nodes in left arm pit on 06Feb2021 05:00. The event Injection site soreness was resolving after 36 hours. There was no other vaccine in four weeks. There was not treatment received for all the events. The patient had no Covid prior vaccination. There was no Covid tested post vaccination. The outcome of the event Injection site soreness was recovering, the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/06/2021,2.0,PVT,LISINOPRIL/HCTZ,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Lymph node pain', 'Lymphadenopathy', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1086952,MI,27.0,F,"Fever; Chills; dizziness; aches; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose bnt162b2 (reported as PFIZER COVID 19 VACCINE, lot number: unknown, Lot number wasn't given when receiving shot), via an unspecified route of administration in right arm on 05Feb2021 07:45 AM at single dose for COVID-19 immunisation. The patient did not have other medical history or known allergies. There were no concomitant medications (no other medications in two weeks). The patient was not pregnant. The patient previously received first dose bnt162b2 (reported as PFIZER COVID 19 VACCINE), via an unspecified route of administration in right arm on 15Jan2021 07:45 AM at single dose for COVID-19 immunisation. The patient experienced Fever, chills, dizziness, aches on 05Feb2021 07:15 PM. AE resulted in 'None of the above'. The patient did not receive treatment for the events. The patient did not have COVID prior vaccination. The patient had COVID tested post vaccination, type was Nasal Swab and result was negative. The outcome of the event was recovering. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,WRK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Dizziness', 'Pain', 'Pyrexia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1086953,NY,,F,"fever, a 100.2 Fahrenheit; Headache; achiness; Sore arm; This is a spontaneous report from a contactable consumer(patient). A 76 years old female patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EM9810), via an unspecified route of administration on 05Feb2021 at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The Historical Vaccine was first dose BNT162B2(LOT number ET1686) for COVID-19 immunization. The patient received the 2nd dose of the vaccine yesterday. She was very happy to get it and she had of course achiness and a headache and a sore arm in Feb2021. She also had fever, a 100.2 Fahrenheit in Feb2021. Her husband will help her take it again, sometimes she cannot hear at the thermometer when it beeps. All she wanted to know they were going up to see her daughter and son-in-law, her grandchildren and her son-in-law's parents today. Of course they would all be wearing mask and when they would be outside, they would be in garage. She wanted to know if it was catching. She did not want to give COVID to anybody. The patient underwent lab tests and procedures, which included Body temperature 100.2 Fahrenheit fever in Feb2021. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/01/2021,,UNK,,,,,,"['Body temperature', 'Headache', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH, 1086954,MI,50.0,F,"Chills; Fever; Tired; Rash; This is a spontaneous report from a contactable consumer reported for herself. A 50-year-old patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL9629 and Expiration Date unknown) via an unspecified route of administration on 04Feb2021 03:00 PM at age of 50-year-old (vaccine location: Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3249 and Expiration Date unknown) via an unspecified route of administration on 13Jan20210 3:15 PM at age of 50-year-old (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history was reported as stroke from Oct2019, no previous covid and no known allergy. There is no other vaccine in four weeks. The concomitant medications reported as acetylsalicylic acid (ASPIRIN) and metoprolol succinate (Toprol 25MG). Patient experienced Chills, then fever, tired, rash from 05Feb2021 06:00 PM. The outcome of events was recovering without treatment given. Information on the batch/Lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,PUB,ASPIRIN [ACETYLSALICYLIC ACID]; TOPROL,,Medical History/Concurrent Conditions: Stroke,,,"['Chills', 'Fatigue', 'Pyrexia', 'Rash']",2,PFIZER\BIONTECH, 1086955,KY,,F,"a small rash on her back and chest; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on an unspecified date (lot/batch number and expiration date not provided), the second dose on 05Feb2021 (lot number: lot number: EL9269), both via an unspecified route of administration at single dose as COVID-19 Vaccine. Medical history included Hypertension, Prediabetes. The patient's concomitant medications were not reported. Caller stated she had gotten the second covid vaccine shot yesterday and had gotten a small rash on her back and chest. Caller wanted to know if it is from the covid vaccine. Consumer further stated she was just wondering if and she had just gotten her second shot yesterday, but after her first shot she had gotten a little bit of a rash on her back and on her chest and she wonder if that were a common occurrence or side effect of this shot. Consumer stated no treatment. No Investigation Assessment. The outcome of the event was unknown. Information about the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Hypertension; Prediabetes,,,['Rash'],1,PFIZER\BIONTECH, 1086956,PA,72.0,M,"Fatigue; injection site pain got worse couldn't sleep on my right side; injection site pain got worse couldn't sleep on my right side; Headache; Muscle aches; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of bnt162b2 (lot number: EN5318), via an unspecified route of administration, at Arm Right, on 05Feb2021 11:30 at Single dose for COVID-19 immunisation. Medical history included allergies to medications, food, cardio vascular disease, glaucoma, high BP, all from an unknown date. The patient's concomitant medications were not reported. The patient previously took tramadol, Lisinopril, statins, lactose and experienced allergies. The patient historical vaccine included first dose of bnt162b2 on 15Jan2021 at Right arm, for COVID-19 immunisation. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. The patient experienced injection site pain got worse couldn't sleep on his right side, headache unusual for him transient but sharp, woke up at 1:00AM serious muscle aches and fatigue like his legs and arms were made of lead. Adverse event started from 06Feb2021 12:00 AM. 90% of all above side effects abated by 8:00AM this morning 06Feb2021. No treatment ae. The outcome of the events were recovered on unspecified date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,PVT,,,"Medical History/Concurrent Conditions: Blood pressure high; Cardiovascular disease, unspecified; Drug allergy (Allergies to medications, food, or other products: tramadol, Lisinopril, statins, lactose); Food allergy (Allergies to medications, food, or other products: tramadol, Lisinopril, statins, lactose); Glaucoma",,,"['Fatigue', 'Headache', 'Insomnia', 'Myalgia', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1086957,,,F,"started getting sick; positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller said she got her first covid vaccine shot last on 19Jan2021 and started getting sick. HCP asked her to get tested with covid and on 29Jan2021 results came out positive. Wanted to know if it is possible for her to get the second covid shot that is scheduled 09Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 29Jan2021. The outcome of the events was unknown. Information on Lot/ Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,01/29/2021,10.0,UNK,,,,,,"['COVID-19', 'Illness', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1086958,,,F,"a low grade fever (99F-100F); slight headache; ""cold symptoms""; coughing; sneezing; blowing her nose; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. About a week later, she reported a low grade fever (99F-100F) along with a slight headache and ""cold symptoms"" including: coughing, sneezing, and blowing her nose. She went for a rapid covid test 9 days after vaccination, which was positive, and she's waiting on an additional covid test that was sent to the lab. The outcome of events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,,,UNK,,,,,,"['Body temperature', 'COVID-19', 'Cough', 'Headache', 'Nasal discomfort', 'Nasopharyngitis', 'Pyrexia', 'SARS-CoV-2 test', 'Sneezing']",1,PFIZER\BIONTECH, 1086959,TX,81.0,F,"gained about 3 pounds now; The next day, her cheeks, face, and the part under her chin became swollen/her body also became swollen; she feels something in her throat which she can't describe; she feels something in her throat which she can't describe; her vision on her good eye became a little depleted; inside of her lips was swollen; This is a spontaneous report from a contactable consumer. This 81-year-old Female consumer reported for herself that she received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose on 27Jan2021 for COVID-19 immunisation. Relevant history included food allergy. Relevant concomitant drug was unknown. The patient received her 1st dose on 27Jan2021 and stated that she was feeling fine for about 10 minutes and when she got back home which was not very far from the vaccination site, she noticed that the inside of her lips was swollen. She mentioned that this was not strange for her since she was mostly allergic to food but usually it was the outer portion of her lips that became swollen and not the inner portion. The next day, her cheeks, face, and the part under her chin became swollen and she felt something in her throat which she could describe. She also noticed that her vision on her good eye became a little depleted which got her a little concerned and her body also became swollen and stated that she already gained about 3 pounds now. She wanted to know if anyone had reported the same reaction she had and if it was recommended for her to get the 2nd dose or not. Outcome of events was unknown. The information on the LOT/Batch number has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Food allergy,,,"['Lip swelling', 'Oropharyngeal discomfort', 'Sensation of foreign body', 'Swelling face', 'Visual impairment', 'Weight', 'Weight increased']",1,PFIZER\BIONTECH, 1086960,NY,33.0,F,"body aches; chills; my back started aching; feeling feverish but no fever; felt like a headache was coming on/was going to get a headache; her arm hurt/arm pain/iced the injection site; never falling back asleep; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Feb2021 15:15 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 on 12Jan2021 for COVID-19 immunization. After 2nd vaccine. The patient felt fine most of the evening and through the night. The patient woke up in the middle of the night around 3/3:30 am (totally normal for her) and felt fine except for some arm pain on 05Feb2021. The patient iced the injection site, but by 4:30/5 the patient was still awake and now felt like she was going to get a headache (also common for patient). The patient took her temperature (was normal), took 2 Tylenol (5am), and went back to bed (but never falling back asleep). The patient left for work at 6:45am. The patient felt totally fine, even energetic, most of the morning. The following day at 10 am caller reported body aches and feeling feverish but no fever. At almost 10am exactly, her back started aching and by 10:30 the patient had full body aches and started getting chills. The patient left work at 11am, was home before 12pm with a temperature of 98.5, took 2 more Tylenol and napped. The patient had no symptoms the rest of the afternoon until 5pm when the back aches returned. Took 2 more Tylenol. The patient napped later in the evening, too, but took 2 more Tylenol at 10pm before going to sleep for the night. Woke up Saturday morning without symptoms. The outcome of events was recovered in Feb2021. Information about Lot/batch number requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/05/2021,1.0,PVT,,,,,,"['Back pain', 'Body temperature', 'Chills', 'Headache', 'Middle insomnia', 'Pain', 'Pyrexia', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1086961,,,F,"UTI; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable female consumer (patient) of an unspecified age reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced UTI (urinary tract infection) on an unspecified date with outcome of unknown. She was currently on antibiotics due to the UTI and wanted to know if that would effect the 2nd dose of the vaccine she was scheduled to get the 2nd dose next Friday 12Feb2021. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Urinary tract infection'],1,PFIZER\BIONTECH, 1086962,,,F,"She reports the rash started on her upper body; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Feb2021 14:00 at single dose in arm for COVID-19 immunization. Medical history included allergic to sulfa drugs. Concomitant medication included BP medications. The patient received her first dose of Pfizer-Biontech Covid19 vaccine, yesterday 05Feb2021 around 2pm. She reported an all-over body rash that woke her up at 3am which she treated with a ointment that she had ""and that helped"". She reported the rash started on her upper body, but now radiated all the way down her buttocks and legs. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/06/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,['Rash'],1,PFIZER\BIONTECH, 1086963,MI,27.0,F,"Headache; fever; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 15:45 at single dose in left arm for COVID-19 immunization. Medical history included allergies to Zithromax. Concomitant medication included topiramate. The patient previously received first dose of BNT162B2 on 13Jan2021 03:45 PM in left arm. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient experienced Headache, fever, chills, nausea, vomiting. Headache began about 2 hours after 2nd dosage administered (03Feb2021 17:45). Rest of symptoms began about 12 hours after headache. Vomiting, fever, chills and nausea all lasted about 8 to 10 hours. Headache lasted about 24 hour. No treatment was received for the events. The outcome of all events was resolved on 04Feb2021. Information about lot/batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/03/2021,02/03/2021,0.0,WRK,TOPIRAMATE,,,,,"['Chills', 'Headache', 'Nausea', 'Pyrexia', 'Vomiting']",2,PFIZER\BIONTECH, 1086964,NY,,F,"stress; She has a cold sore; a little puffy around her lip; This is a spontaneous report from a contactable consumer reporting for self via Pfizer sponsored program. A female patient of an unspecified age (age: 92 or 79, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Feb2021 at single dose for covid-19 immunisation. Patient received the first dose on unknown date. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient has a cold sore that started coming on a few days ago. It didn't come out yet but it has been a little puffy around her lip starting 3-4 days ago. She stated, with all the stress from the whole year her resistance is probably low but it has nothing to do with the vaccine. She definitely knows it is from all the stress going on. She stated she had relatively no effects from either dose. She asked if it is okay to take Valacyclovir for the cold sore. After verbal response provided, she stated she probably will err on being conservative and not take it. She wanted to take Valaciclovir (for herpes) but she don't want to do anything since she waited so long for the vaccine and she would like to ask if it is okay to take another medication after her 2nd shot. Outcome of events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,,,UNK,,,,,,"['Oral discomfort', 'Oral herpes', 'Stress']",2,PFIZER\BIONTECH, 1086965,NY,66.0,F,"having lots of Gastrointestinal issues/have gastrointestinal stuff going on; up in the middle of the night; body aches/achy; chills (no fever); nausea; got the sore arm; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318 (not clarified further)), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunisation and loratadine (CLARITIN), via an unspecified route of administration from 03Feb2021 at an unspecified dose for unspecified indication. Medical history included ongoing High cholesterol and Sleep disorder, both from unknown date. Concomitant medication included alprazolam (XANAX), calcium (CALCIUM), cyanocobalamin (VITAMIN B12), Multivitamin, taking a statin to prevent high cholesterol and L-methylfolate, stated it is like a folic acid drug. Because the patient really can't take anti-depressant she reacted to them all (Unspecified Medications), so that worked for her and helped her to keep up her spirit. The patient reported her side effects. She didn't want to interfere with anything but she was having lots of Gastrointestinal issues which were inconvenient. She was up in the middle of the night, happened not within 48 hour after the first dose of the Pfizer vaccine but around 60 hours after the vaccine, early this morning (06Feb2021) like around 2 am. The patient was having a reaction after the vaccine but they seemed to be like delayed reactions. Not anything with breathing, she had gastrointestinal stuff going on. The patient had chills, no fever, body aches and she was really going to the bathroom nonstop in the night. It seemed to have been like 2 days after she got the shot like they were worst yesterday (05Feb2021). And she experienced achy, chills, nausea, diarrhea and sore arm in Feb2021. She would like to take TYLENOL and IMODIUM and she didn't know what she could take because she didn't want anything to interfere with that as she had been reading a lot. The patient wanted information on IMODIUM to prevent diarrhea, TYLENOL for body aches, chills (no fever), and FLONASE for sinus. The patient did not receive any treatment for the events. The patient actually didn't even take, that morning that day when she was getting the shot, she called the pharmacist to see if she could spray her nose with the FLONASE for sinus and he told her that he didn't think it was a good idea and that maybe she should just take CLARITIN, so she did. But she took CLARITIN that morning (03Feb2021) and she was hoping that didn't interfere. She was just nervous about it as she didn't want that to interfere with the work that it was. The patient was still suffering, less, like she didn't have the diarrhea anymore. She still had a little achy. She did get the sore arm but only for one day, so it wasn't so bad. The action taken in response to the events for loratadine was unknown. The outcome of event diarrhea and got the sore arm was recovered on an unspecified date in Feb2021, of event achy was recovering, of other events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/01/2021,,UNK,XANAX; CALCIUM; VITAMIN B12 [CYANOCOBALAMIN]; L-METHYLFOLATE,High cholesterol,Medical History/Concurrent Conditions: Sleep disorder,,,"['Chills', 'Diarrhoea', 'Gastrointestinal disorder', 'Middle insomnia', 'Nausea', 'Pain', 'Pain in extremity']",UNK,UNKNOWN MANUFACTURER, 1086966,IL,46.0,F,"Appear to be either Shingles or hives, itchy spots on neck face and scalp; Appear to be either Shingles or hives, itchy spots on neck face and scalp; Appear to be either Shingles or hives, itchy spots on neck face and scalp; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9265), via an unspecified route of administration in left arm on 05Feb2021 10:30 at single dose for COVID-19 immunization. Medical history included Allergic to shellfish, Allergic to soy, Mould allergy, pollen allergies, Atopic dermatitis. There were no concomitant medications. The patient previously took dupilumab (DUPIXENT) from unknown date to 20Dec2020 for Atopic dermatitis. The patient experienced appear to be either shingles or hives, itchy spots on neck face and scalp on 06Feb2021 06:00. Treatment received for the events included Desoxymetasone steroid applied without any effect. The patient was not pregnant. The patient had no COVID prior vaccination. She had no COVID tested post vaccination. There was no other vaccine received at the same date of the COVID-19 vaccine. There was no other vaccine received in four weeks. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,WRK,,,Medical History/Concurrent Conditions: Allergy to moulds; Atopic dermatitis; Pollen allergy; Shellfish allergy; Soy allergy,,,"['Herpes zoster', 'Pruritus', 'Urticaria']",UNK,PFIZER\BIONTECH, 1086967,,,M,"Covid vaccine given, 4 days later infected with Covid; This is a spontaneous report from a contactable Physician. A male patient of an unspecified age received bnt162b2 (BNT162B2) first dose, via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced covid vaccine given, 4 days later infected with covid on an unspecified date with outcome of unknown.Reported Question: Covid vaccine given, 4 days later infected with Covid. He was treated with Bamlanivimab 1 week after vaccine. Should this patient got both doses of vaccine in 3 months? Information about Lot/ Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['COVID-19'],1,PFIZER\BIONTECH, 1086968,,,F,"extremely cold and she thought it's because of the PEG within it; I'm extremely cold/freeze to death; Shaky; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included high blood pressure and it hadn't been this high in a quiet a few years, colonoscopy. The patient's concomitant medications were not reported. The patient was extremely cold and she thought it's because of the PEG within it. PEG is one of excipients of BNT162B2. Last year, when the patient had her colonoscopy done, they gave her Gavilyte and she frozen to death, walked like a frozen death person (Miralax/Gavilyte) It was for about a week. She stayed so cold. It took all her vitamins, that stuff was wicked. As she ate different foods that had the component in it. She felt better. The last one she ate was potato chips (eat very few). It was the salt, so she could eat more. The salt in the chips straightened her out. Gavilyte took the salt out of her system. The patient had to drink 12 Gatorades. It was making her fall. It's not the chills, she was cold from the inside out. It was worse than being cold from cleaning a walk in freezer. She was a ""walking dead person"" same cold. It's that bad. She had 3 outfits on, a cold and blankets. Never been that cold in her life and it was from Gavilyte. (After receiving the first dose of the Pfizer vaccine) She felt that away for about a week and now it's gone. It brought it all back, same feeling, freeze to death, shaky. The patient stated she would see her heart doctor. The outcome of events was unknown. On 17Feb2021 she's scheduled for the 2nd dose of BNT162B2.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: Blood pressure high (it hadn't been this high in a quiet a few years); Colonoscopy,,,"['Feeling cold', 'Reaction to excipient', 'Tremor']",1,UNKNOWN MANUFACTURER, 1086969,,,F,"a little tired; her arm is a little sore; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program. A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the night of 05Feb2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was a little tired and her arm was a little sore on an unspecified date. The event outcome was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,,,UNK,,,,,,"['Fatigue', 'Pain in extremity']",1,PFIZER\BIONTECH, 1086970,MD,68.0,M,"I didn't sleep last night; parts of face and under chine was swollen; BP102 at 3pm blood pressure was 132/82; This is a spontaneous report from a contactable Other HCP. A 68-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261), via an unspecified route of administration on 05Feb2021 08:15 at single dose, right arm for COVID-19 immunization. Medical history included high blood pressure, Crohn's disease and mental health issues. Known allergies included valproate semisodium(DEPAKOTE) and fluoxetine hydrochloride(PROZAC). The patient's concomitant medications were not reported. The patient didn't sleep last night. Parts of face and under chine was swollen, blood pressure(BP) 102 at 3pm blood pressure was 132/82. Noticed after waking up at 2:30PM. The patient went to sleep at 9:30pm. Events start date was 05Feb2021, 03:00PM. Events resulted in: Doctor or other healthcare professional office/clinic visit. There was no covid prior vaccination, no covid tested post vaccination. No treatment received for the events. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/05/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Blood pressure high; Crohn's disease; Mental disorder,,,"['Blood pressure increased', 'Blood pressure measurement', 'Sleep disorder', 'Swelling face']",1,PFIZER\BIONTECH, 1086971,PA,,F,"skin felt like itchy pinpricks all over; tiredness; dizziness/lightheadedness; This is a spontaneous report from a contactable Consumer (Patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration at left arm on an unknown date in Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included Chronic Sinusitis, patient's known allergies: Systemic steroids, Amoxicillin, Prednisone, Cortizone, Levofloxacin, Famotidine, Apples, Pineapples, Shellfish. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE), colecalciferol (D3), cyanocobalamin (VITAMIN B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Skin felt like itchy pinpricks all over, tiredness, dizziness and lightheadedness for about 2 days happened eight days after receiving first dose on an unknown date in Jan2021. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/01/2021,01/01/2021,0.0,PVT,LISINOPRIL AND HYDROCHLOROTHIAZIDE; D3; VITAMIN B12 [CYANOCOBALAMIN],,"Medical History/Concurrent Conditions: Chronic sinusitis; Drug allergy (Known allergies: Systemic steroids); Fruit allergy (Apples, Pineapples); Shellfish allergy",,,"['Dizziness', 'Fatigue', 'Pruritus']",1,PFIZER\BIONTECH, 1086972,WY,50.0,F,"joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection site pain; malaise; muscle cramping; swollen lymph nodes; projectile vomiting; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN9581) via an unspecified route of administration in right arm on 03Feb2021 15:45 at single dose for covid-19 immunisation. Medical history included diabetes, hypertension (HTN), and gastrooesophageal reflux disease (GERD). Known allergies included xylometazoline hydrochloride (SUDAFED). Concomitant medication included omeprazole (PROTONIX), metformin hydrochloride, sitagliptin (JANUMET), empagliflozin (JARDIANCE), insulin glargine (BASAGLAR), escitalopram oxalate (LEXAPRO). There was no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient experienced joint pain, weakness, chills, diarrhea, dizziness, minor difficulty breathing, headache, injection site pain, malaise, muscle cramping, swollen lymph nodes, projectile vomiting, all on 04Feb2021 09:15 with outcome of recovering. No treatment received for the events.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,PUB,PROTONIX [OMEPRAZOLE]; JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN]; JARDIANCE; BASAGLAR; LEXAPRO,,Medical History/Concurrent Conditions: Diabetes; GERD; Hypertension,,,"['Arthralgia', 'Asthenia', 'Chills', 'Diarrhoea', 'Dizziness', 'Dyspnoea', 'Headache', 'Lymphadenopathy', 'Malaise', 'Muscle spasms', 'Vaccination site pain', 'Vomiting projectile']",1,PFIZER\BIONTECH, 1086973,NJ,75.0,F,"Severe arm pain going down to hands and fingers.; could not unfold elbow or arm due to pain; She could not dress b/c the feeling of clothing in arm was excruciating.; This is a spontaneous report from a consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (lot/batch number and expiration date were unknown) via an unspecified route of administration at left arm on 02Feb2021 08:00 at single dose for covid-19 vaccine. Medical history included diabetes and hypertension. Unspecified concomitant medication used in two weeks. There was no known allergies. There was no other vaccine in four weeks. Patient did not have COVID prior vaccination. The patient had severe arm pain going down to hands and fingers on 02Feb2021 at 18:00. She had severe sensitivity. She could sleep due to pain but could not unfold elbow or arm due to pain. She could not dress b/c the feeling of clothing in arm was excruciating. She was in tears. It was been about 5 days and the pain and sensitivity has increased every day. Patient had taken paracetamol (Tylenol), ibuprofen (Advil) went to my primary and got prescribed tramadol for pain. Nothing was helping. Patient visited doctor or other healthcare professional office/clinic visit due to events. She did not have COVID tested post vaccination. The outcome of events was not recovered. Information on batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/01/2021,,PVT,,,Medical History/Concurrent Conditions: Diabetes; Hypertension,,,"['Joint range of motion decreased', 'Loss of personal independence in daily activities', 'Pain in extremity']",1,PFIZER\BIONTECH, 1086974,CA,68.0,M,"Rash on back and partially on chest; This is a spontaneous report from a contactable consumer (Patient). A 68-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 23Jan2021 14:00 at single dose at Left arm for covid-19 immunisation . Medical history included type 1 diabetes mellitus. Concomitant medication included insulin. The patient experienced rash on back and partially on chest on 23Jan2021. This has persisted since vaccination date (23Jan2021) until 06Feb2021. Therapeutic measures were taken as a result of rash on back and partially on chest included Benadryl and Calamine. The outcome of event was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/23/2021,0.0,PUB,INSULIN,,Medical History/Concurrent Conditions: Type 1 diabetes mellitus,,,['Rash'],1,PFIZER\BIONTECH, 1086975,AZ,39.0,F,"Left hand tingling and cold.; Left hand tingling and cold.; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9264), via an unspecified route of administration in left arm on 06Feb2021 15:30 at single dose for COVID-19 immunisation. Medical history included asthma. She had no known allergies. Concomitant medication included beclometasone dipropionate (QVAR) and mometasone furoate (FLONASE). The patient experienced left hand tingling and cold on 06Feb2021 15:30. No treatment received for the events. The patient was not pregnant. The patient had no COVID prior vaccination. She had no COVID tested post vaccination. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/06/2021,02/06/2021,0.0,SCH,QVAR; FLONASE [MOMETASONE FUROATE],,Medical History/Concurrent Conditions: Asthma,,,"['Paraesthesia', 'Peripheral coldness']",1,PFIZER\BIONTECH, 1086976,IL,27.0,F,"received first dose on 27Dec2020 and second dose on 13Jan2021; received first dose on 27Dec2020 and second dose on 13Jan2021; chills; fever; dizziness; headache; nausea; lack of appetite; fatigue; hot flashes; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, ), intramuscular in the Left arm on 13Jan2021 13:30 PM at single dose for covid-19 immunisation. Patient was not pregnant. Medical history was None. No known allergies. No other medical history. No other vaccine in four weeks. Other medications in two weeks included Birth control. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899, administrator route=Intramuscular, vaccine location=Left arm) on 27Dec2020 at age of 27 years old for COVID-19 immunization and nothing after the first shot. The night of the second shot (13Jan2021) patient had chills, fever, dizziness, headache, nausea, lack of appetite, fatigue, and hot flashes until the following two days (15Jan2021). Then dizziness, fatigue, nausea, lack of appetite, chills, and hot flashes for about a week (in Jan2021). No treatment for the adverse events. No covid prior vaccination. No covid tested post vaccination. The patient administered vaccine in Doctor's office/urgent care. The outcome of 'received first dose on 27dec2020 and second dose on 13jan2021' was unknown, of other events was recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/13/2021,01/13/2021,0.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Decreased appetite', 'Dizziness', 'Fatigue', 'Headache', 'Hot flush', 'Inappropriate schedule of product administration', 'Nausea', 'Off label use', 'Pyrexia']",2,PFIZER\BIONTECH,OT 1086977,FL,72.0,M,"Soreness at injection site; tiredness; achiness; slight fever 99.2 degrees; This is a spontaneous report from a contactable consumer(patient) . A 72-year-old male patient received the second dose of BNT162B2 (lot number: EL9262), via an unspecified route of administration in left arm, on 05Feb2021 15:00 at single dose for COVID-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. The patient had previously received the 1st dose of BNT162B2(Lot number: EL3246) on 15Jan2021 03:00 PM in left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. No known allergies. No other vaccines were received within 4 weeks. The patient experienced soreness at injection site, tiredness, achiness, slight fever 99.2 degrees on 06Feb2021. No treatment was received for the event. The patient underwent lab test included body temperature: 99.2 degrees on 06Feb2021. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'Fatigue', 'Pain', 'Pyrexia', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1086978,AL,54.0,F,"sore arm; slept for 17 straight hours; chills; upset stomach; upper body flushing for up to 4 days later; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 16Jan2021 08:00 at single dose for COVID-19 immunization. Medical history included Known allergies to Possible latex, Diabetes, sleep apnea, PTSD (Post-traumatic stress disorder)/anxiety, herpes, vitamin d deficiency, environmental allergies, asthma. Concomitant medication was unspecified medication in two weeks. On 16Jan2021 08:00, The patient experienced sore arm, slept for 17 straight hours, chills, upset stomach, upper body flushing for up to 4 days later. Treatment received for the events included OTC medications. The patient was not pregnant. She had no COVID tested post vaccination. There was no other vaccine received in four weeks. The outcome of the events was recovered in 2021. information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/16/2021,01/16/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Anxiety; Asthma; Diabetes; Environmental allergy; Herpes simplex; Latex allergy; Post-traumatic stress disorder; Sleep apnea; Vitamin D deficiency,,,"['Abdominal discomfort', 'Chills', 'Flushing', 'Hypersomnia', 'Pain in extremity']",1,PFIZER\BIONTECH, 1086979,IL,75.0,F,"my heart beating fast/the pulse reading 170; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE, Lot number unknown), via an unspecified route of administration in the right arm on 05Feb2021 15:00 at SINGLE DOSE for covid-19 immunisation. Medical history included arthritis and Penicillin Allergies. The patient was not pregnant. The patient did not receive other vaccine on the same date and in four weeks. The patient's concomitant medications were unspecified other medication in two weeks. Yesterday (05Feb2021) the patient received her first dose of Covid-19 vaccine at (vaccine facility name) around 3PM. They had everyone wait in the observation room for 15 minutes after the shot. She was fine during that time. In the evening around 8PM she noticed that her heart beating fast. A home use Oximeter showed the pulse reading 170 around 10PM. An hour later it went down to 105. This morning it came down to 84. She slept well last night. Her next appointment for the second dose is on 26Feb2021. Ae resulted in [None of the above]. The patient did not receive treatment for adverse event. The patient did not have COVID prior vaccination. The patient did not have COVID tested post vaccination. This event was non-serious and did not result in death and cause/prolong hospitalization, was not life threatening, Disabling/Incapacitating, Congenital anomaly/birth defect. Facility type Vaccine was Hospital. The outcome of the event was recovered on 06Feb2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Arthritis; Penicillin allergy,,,"['Heart rate', 'Heart rate increased']",1,PFIZER\BIONTECH, 1086980,CA,82.0,F,"Fever; feeling unwell; muscle pain; chills; injection site pain; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) via an unspecified route of administration in right arm on 05Feb2021 17:15 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bacitracin and experienced allergies, nalidixic acid and experienced allergies. The patient experienced fever, feeling unwell, muscle pain, chills, injection site pain, all in Feb2021. No treatment received. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/01/2021,,UNK,,,,,,"['Chills', 'Malaise', 'Myalgia', 'Pyrexia', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1086981,IN,74.0,M,"inflamed testicle; testicle infection/ got an infection in the testicles; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , via an unspecified route of administration on 21Jan2021 15:00 at single dose left arm for covid-19 immunisation. Medical history included ongoing inflamed testicle, H blood pressure. Concomitant medication included apixaban (ELIQUIS), venlafaxine, carvedilol, terazosin, lisinopril. The patient was getting ready to take second shot on 14Feb2021, on 04Feb2021 patient started Sulfamethoxazole-TMP Ds Tablets for inflamed testicle. The patient had first shot of the COVID and did not have any problem. Since then patient got an infection in the testicles and then gave antibiotics (treatment) for the 4th of this month. So, the patient had 2, 3 doses of it. The patient was due to have second COVID shot on 14Feb2021 and patient am just trying to find out if patient should stop the antibiotics. The outcome of events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,,,PVT,ELIQUIS; VENLAFAXINE; CARVEDILOL; TERAZOSIN; LISINOPRIL,Testicular inflammation,Medical History/Concurrent Conditions: Blood pressure high,,,"['Orchitis', 'Orchitis noninfective']",1,PFIZER\BIONTECH, 1086982,FL,66.0,F,"Fatigue; body aches; headache; general malaise; This is a spontaneous report from a consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (lot/batch number and expiration date were unknown) via an unspecified route of administration at left arm on 05Feb2021 13:30 at single dose for COVID-19 immunisation. Medical history included idiopathic hypertrophic subaortic stenosis (IHSS). Unspecified concomitant medication used in two weeks. There was no known allergies. There was no other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not pregnant. The patient had fatigue, body aches, headache and general malaise on 06Feb2021 at 08:00 a.m. Patient did not receive any treatment for events. She did not have COVID tested post vaccination. The outcome of events was recovering. Information on batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,OTH,,,Medical History/Concurrent Conditions: Idiopathic hypertrophic subaortic stenosis,,,"['Fatigue', 'Headache', 'Malaise', 'Pain']",1,PFIZER\BIONTECH, 1087016,FL,35.0,F,"swollen eye; hives; This is a spontaneous report from a contactable Nurse, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899), via an unspecified route of administration on 11Jan2021 at 15:30 (at the age of 35-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included insulin resistance, vitamin D deficiency, GERD (Gastrooesophageal reflux disease) and allergy to pollen and possible allergy to cilantro. Prior to the vaccination, it was unknown if the patient was not diagnosed with COVID-19. Concomitant medications included metformin, famotidine (PEPCID [FAMOTIDINE]), clarithromycin (CLARITIN [CLARITHROMYCIN]), topirmate, and diphenhydramine hydrochloride (BENADRYL); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took pregabalin (LYRICA) from an unknown date for an unknown indication and experienced allergy. On 01Feb2021 at 06:00, the patient experienced hives and swollen eye. The patient reported that the first vaccine was administered and the patient was fine then the patient had hives and swollen eye on the day the second dose was to be administered. The second dose of the vaccine was delayed. The events resulted in an emergency room/urgent care visit and the patient received treatment for the events with solumedrol shot and prednisone oral with benadryl/pepcid/atarax. The patient received the second dose one week later, on Friday 05Feb2021, with prednisone on board. The clinical outcomes of the hives and swollen eye were recovering. It was also reported that since the vaccination, it was unknown if the patient had been tested for COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Swollen eyes and Hives cannot be totally excluded. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,02/01/2021,21.0,PVT,METFORMIN; PEPCID [FAMOTIDINE]; CLARITIN [CLARITHROMYCIN]; TOPIRAMATE; BENADRYL,,Medical History/Concurrent Conditions: Food allergy (possible allergy to cilantro); GERD; Insulin resistance; Pollen allergy; Vitamin D deficiency,,,"['Eye swelling', 'Urticaria']",1,PFIZER\BIONTECH, 1087035,PA,54.0,F,"difficulty inhaling; cough; hives; tongue and lips tingling; tongue and lips tingling; itching; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL 3246/expiration date: not provided), via an unspecified route of administration, on 15Jan2021 at 08:00 (at the age of 54 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1284/expiration date: not provided), via an unspecified route of administration, on 26Dec2020 at 10:00 (at the age of 54 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included exercised induced asthma, and psoriatic eczema. The patient had known allergies to penicillin, fentanyl, and levofloxacin (LEVAQUIN). Concomitant medication included levothyroxine sodium (SYNTHROID) and atorvastatin (LIPITOR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Jan2021 at 08:15, the patient experienced difficulty inhaling, cough, hives, itching, tongue and lips tingling. The events resulted in an emergency room visit. The patient received treatment for these events which included treatment epi: IV fluids, IV benadryl, Pepcid, Solumedrol then IM. The outcome of the events difficulty inhaling, cough, hives, itching, tongue and lips tingling was recovered with lasting effects (sequel) on an unspecified date in 2021. Since the vaccination, the patient had not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/15/2021,0.0,PVT,SYNTHROID; LIPITOR,,Medical History/Concurrent Conditions: Asthma; Eczema; Penicillin allergy,,,"['Cough', 'Dyspnoea', 'Paraesthesia oral', 'Pruritus', 'Urticaria']",2,PFIZER\BIONTECH, 1087050,NY,,F,"Drug ineffective; SARS-CoV-2 test positive; This is a spontaneous report from a non-contactable consumer reported for herself. An adult female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 05Jan2021 for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient was not pregnant. No COVID prior vaccination. On 06Feb2021 the patient tested positive for Covid 19 via nasal swab. The outcome of the event was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/05/2021,02/06/2021,32.0,PVT,,,,,,"['Drug ineffective', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH, 1087060,NY,,F,"Tested positive before 2nd dose; Tested positive before 2nd dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported a female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient tested positive for COVID-19 before the second dose of BNT162B2. The outcome of tested positive before 2nd dose was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Drug ineffective', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1087069,,,M,"went for the rapid test/positive/have COVID; went for the rapid test positive/have COVID; No sense of taste or smell; No sense of taste or smell; Coughing; Fatigue extreme; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports, reporting for the husband. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 to 20Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing chronic fatigue syndrome. The patient's concomitant medications were not reported. The patient exhibited a lot of symptoms. And he by the way he complicated things. He got his shot, his first Pfizer shot on 20Jan2021, and then on the 24Jan2021 he left to go to (Name). He came home on the end of the week, he came on Friday. He was coughing and exhibiting extreme fatigue in Jan2021, but he also suffered from chronic fatigue syndrome and other underline situations, so he attributed to that. So he went ahead and they cohabitated and on Sunday the consumer started to get these symptoms. This past Wednesday (03Feb2021) he came to consumer and said he had no sense of taste or smell, and they knew what that meant. So, he immediately went to get a COVID test, but he had to wait. And then in the interim the consumer's situation pretty much stayed rather static, it didn't much change. Then on Thursday (04Feb2021) he said he was going for a rapid test, and consumer said wanted to go too. So, they went ahead and they went to an urgent care and they went for the rapid test and they were both been positive. They both had COVID. The event outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021145196 same reporter/product, different patient, similar event",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/01/2021,,UNK,,Chronic fatigue syndrome,,,,"['Ageusia', 'Anosmia', 'COVID-19', 'Cough', 'Drug ineffective', 'Fatigue', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1087078,OH,,U,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable pharmacist through a Pfizer-sponsored program. This pharmacist reported similar events for three patients. This is the first of the three reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 17Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. On an unspecified date in 2021, the patient had COVID-19 confirmed by positive COVID-19 test, and was put on isolation. The outcome of the event, 'COVID-19 confirmed by positive COVID-19 test', was unknown. The reporting pharmacist was wondering the there was a need to hold off the second dose of vaccination. Information on the lot/batch number has been requested.; Sender's Comments: The contributory role of the suspect product to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.,Linked Report(s) : US-PFIZER INC-2021148567 same reporter/product/events, different patient;US-PFIZER INC-2021148568 same reporter/product/events, different patient;US-PFIZER INC-2021148567 same drug and event, different patient;US-PFIZER INC-2021148568 same drug and event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/17/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1087082,OH,,U,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer-sponsored program, PFIZER FIRST CONNECT. A contactable pharmacist reported similar events for three patients. This is the third of the three reports. A patient of unspecified age and gender received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Jan2021, for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. On an unspecified date in 2021, after the first vaccination, the patient had COVID-19 confirmed by positive COVID-19 test and was put on isolation. The outcome of the event was unknown. The reporting pharmacist was wondering if there was a need to hold off the second dose of vaccination or if it could be administered on 07Feb2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity after the first vaccine dose.,Linked Report(s) : US-PFIZER INC-2021148508 same drug and event, different patient;US-PFIZER INC-2021148568 same drug and event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/17/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1087143,ID,39.0,M,"myocarditis; severe chest pain; developed severe flu symptoms; This is a spontaneous report from a contactable healthcare professional (patient). A 39-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration in the left arm on 02Feb2021 at 08:30 AM (at the age of 39 years old) at a single dose for COVID-19 immunization. The vaccine was administered to the patient at a hospital. The patient had no medical history and had no known allergies. The patient had no COVID prior to vaccination. Concomitant medication included testosterone. The patient had no other vaccine in four weeks. The patient previously received the first dose of BNT162B2 on 12Jan2021 at 12:30 AM (at the age of 39 years old) in the left arm for COVID-19 immunization. The patient developed severe flu symptoms on 02Feb2021 at 20:30. The patient experienced chest pain and myocarditis on 12Feb2021 at 03:00 AM. It was reported that after 12 hours, the patient developed severe flu symptoms for the following 48 hours. Then she developed severe chest pain and was hospitalized for myocarditis. The patient was hospitalized in Feb2021 for 5 days. The patient received treatment for the events which included heart medications and heart angiogram. The patient was tested for COVID post vaccination which included blood test and nasal swab, both with negative results on 12Feb2021. The outcome of the event was recovering. Information on the batch/lot number has been requested.; Sender's Comments: The event myocarditis was most likely due to influenza, which was an intercurrent infection, and unrelated to suspect vaccine BNT162B2. There is no plausible mechanism implicating BNT162B2 to the reported event based on the drug known safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,02/02/2021,02/02/2021,0.0,PVT,TESTOSTERONE,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Chest pain', 'Influenza', 'Myocarditis', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1087145,,,F,"tested positive for COVID-19; tested positive for COVID-19; COVID bronchitis; chest tightness; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included she believed she was exposed to COVID-19 on 23Jan2021. Concomitant medications were not reported. The patient tested positive for COVID-19 on 30Jan2021. She received her second dose 41 days after the first dose because she was experiencing a cough and some chest tightness and she was told she had COVID bronchitis on an unspecified date in 2021. She received a prescription for Azithromycin (Z-pak) and methylprednisolone for COVID bronchitis. The second dose was administrated at present date. The outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/30/2021,16.0,UNK,,,Medical History/Concurrent Conditions: Exposure to COVID-19,,,"['Bronchitis', 'COVID-19', 'Chest discomfort', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1087146,,87.0,M,"Patient who received 2 doses of covid-19 vaccine (Pfizer) is now Covid positive with chest x-ray positive for covid pneumonia. Patient reports symptoms has started 5 days prior to admission, 2nd dose; Patient who received 2 doses of covid-19 vaccine (Pfizer) is now Covid positive with chest x-ray positive for covid pneumonia. Patient reports symptoms has started 5 days prior to admission, 2nd dose; This is a spontaneous report from a non-contactable Other HCP. An 87-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Feb2021 at 100 ug/ml (30mcg/0.3mL), single for Covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 87-year-old for Covid-19 immunisation. The patient who received 2 doses of cCvid-19 vaccine (Pfizer) was now Covid positive with chest X-ray positive for Covid pneumonia in Feb2021. Patient reports symptoms has started 5 days prior to admission, 2nd dose was administered 10 days prior to admission. No COVID tested post vaccination. Decadron and remdesivir were received for the event. Outcome of the events was unknown. No follow up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. However the short duration of 5 days since the vaccine second dose is given it is unlikely patient would have fully developed immunity.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,,,,,"['COVID-19 pneumonia', 'Chest X-ray', 'Drug ineffective']",2,PFIZER\BIONTECH, 1087151,,,U,"tested positive between doses 1 and 2 of the vaccine; tested positive between doses 1 and 2 of the vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported same events for six patients. This is second case of six reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that 6 patients tested positive between doses 1 and 2 of the vaccine, in which the pharmacist was giving Covid vaccinations in a nursing home. It was reported that the patient was tested positive between doses 1 and 2 of the vaccine, in which the patient was hospitalized and had received antibodies. And had tested negative upon and continuously since returning to the nursing home. Those patients were tested every day. The pharmacist started administering the second doses. One patient was administered the second dose and then somebody said, ""Oh, they were given antibodies in the hospital''. A fellow pharmacist in which they said, we're under the impression you wait 90 days if they've been given antibodies after that to give the second dose. One of the patients inadvertently received a second dose, not knowing that they received antibody therapy prior to administering the vaccine. The rest who were hospitalized did not receive their second injection. Caller asked, ""What is the policy on antibodies and the second dose? When is the earliest date they can administer that second dose? The individual who was given it inadvertently, should they be given a third injection? Do you give them shot number two or do you start over and give them both shots?'' The outcome of event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the information provided, the lack of efficacy cannot be totally excluded for vaccine BNT162B2 administration. The specific test date of positive COVID-19, and the injection date of vaccine BNT162B2 would be helpful for further assessment.,Linked Report(s) : US-PFIZER INC-2021199894 same drug/reporter/event, different patient",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,SEN,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1087152,,,U,"tested positive between doses 1 and 2 of the vaccine; tested positive between doses 1 and 2 of the vaccine; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for six patients. This is the 3rd of six reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was tested positive on an unknown date for covid-19 between doses 1 and 2 of the vaccine, in which the patient was hospitalized and had received antibodies. And had tested negative upon and continuously since returning to the nursing home on an unknown date. Those patients were tested every day. One patient was administered the second dose and then somebody said, ""Oh, they were given antibodies in the hospital''. A fellow pharmacist in which they said, ""we're under the impression that you wait 90 days if you have been given antibodies after that to give the second dose"". One of the patients inadvertently received a second dose, not knowing that they received antibody therapy prior to administering the vaccine. The rest of who were hospitalized did not receive their second injection. Caller asked, ""What is the policy on antibodies and the second dose? When is the earliest date they can administer that second dose? The individual who was given it inadvertently, should they be given a third injection? Do you give them shot number two or do you start over and give them both shots?'' The outcome of events was resolved on an unknown date. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is expected only 7 days after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021199894 same drug/reporter/event, different patient;US-PFIZER INC-2021222956 same drug/reporter/event, different patient",Not Reported,,Not Reported,Yes,,Not Reported,Y,,,,SEN,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1087153,,,U,"6 patients tested positive between doses 1 and 2 of the vaccine; 6 patients tested positive between doses 1 and 2 of the vaccine; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for six patients. This is the 4th of six reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was tested positive on an unknown date for covid-19 between doses 1 and 2 of the vaccine, in which the patient was hospitalized and had received antibodies. And had tested negative upon and continuously since returning to the nursing home on an unknown date. Those patients were tested every day. One patient was administered the second dose and then somebody said, ""Oh, they were given antibodies in the hospital''. A fellow pharmacist in which they said, ""we're under the impression that you wait 90 days if you have been given antibodies after that to give the second dose"". One of the patients inadvertently received a second dose, not knowing that they received antibody therapy prior to administering the vaccine. The rest of who were hospitalized did not receive their second injection. Caller asked, ""What is the policy on antibodies and the second dose? When is the earliest date they can administer that second dose? The individual who was given it inadvertently, should they be given a third injection? Do you give them shot number two or do you start over and give them both shots?'' The outcome of events was recovered on an unknown date. Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021199894 same drug/reporter/event, different patient;US-PFIZER INC-2021222956 same drug/reporter/event, different patient",Not Reported,,Not Reported,Yes,,Not Reported,Y,,,,SEN,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1087154,,,U,"tested positive between doses 1 and 2 of the vaccine; tested positive between doses 1 and 2 of the vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 6 patients. This is the 5th of 6 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that 6 patients tested positive between doses 1 and 2 of the vaccine, in which the pharmacist was giving Covid vaccinations in a nursing home. It was reported that the patient was tested positive between doses 1 and 2 of the vaccine, in which the patient was hospitalized and had received antibodies. And had tested negative upon and continuously since returning to the nursing home. Those patients were tested every day. The pharmacist started administering the second doses. One patient was administered the second dose and then somebody said, ""Oh, they were given antibodies in the hospital''. A fellow pharmacist in which they said, we're under the impression you wait 90 days if they've been given antibodies after that to give the second dose. One of the patients inadvertently received a second dose, not knowing that they received antibody therapy prior to administering the vaccine. The rest who were hospitalized did not receive their second injection. Caller asked, ""What is the policy on antibodies and the second dose? When is the earliest date they can administer that second dose? The individual who was given it inadvertently, should they be given a third injection? Do you give them shot number two or do you start over and give them both shots?'' The outcome of event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on data provided and temporal association, the event are assessed as possibly related to BNT162B2.,Linked Report(s) : US-PFIZER INC-2021222957 same drug/reporter/event, different patient;US-PFIZER INC-2021199894 same drug/reporter/event, different patient;US-PFIZER INC-2021222953 same drug/reporter/event, different patient;US-PFIZER INC-2021222955 same drug/reporter/event, different patient;US-PFIZER INC-2021222954 same drug/reporter/event, different patient",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1087155,,34.0,F,"The mother was 38 Weeks pregnant at the onset of the event; Chills, aching at injection site, and low grade fever; Chills, aching at injection site, and low grade fever; Chills, aching at injection site, and low grade fever/Highest recorded fever 99.7 degrees F; This is a spontaneous report from a contactable other HCP. A 34-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration from 02Feb2021 14:30 at SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient received first dose of BNT162B2 for COVID-19 vaccine on 12Jan2021 at 2:30pm in left arm. The patient's second dose was on 02Feb2021 and the patient was approximately 37 weeks pregnant. That night and the next day, on 04Feb2021 12:45, the patient had chills, aching at injection site, and low grade fever for which the patient took acetaminophen prn (as needed). Highest recorded fever 99.7 degrees F. The mother was 38 Weeks pregnant at the onset of the event. On Feb2021 at 12:50am, the patient's water broke 2.5 weeks before the due date. The patient was admitted to the local hospital and the baby was delivered without complications. Discharged on 05Feb2021. Unsure if early delivery related to vaccination, but thought it worth reporting since there is limited data on pregnant women and the vaccine. The patient underwent lab tests and procedures which included body temperature: low grade fever fahrenheit, body temperature: 99.7 fahrenheit on Highest recorded fever 99.7 degrees F, sars-cov-2 test: negative on 03Feb2021. Treatment was received for the event low grade fever. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/02/2021,02/04/2021,2.0,PVT,PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,,,,"['Body temperature', 'Chills', 'Maternal exposure during pregnancy', 'Pyrexia', 'SARS-CoV-2 test', 'Vaccination site pain']",2,PFIZER\BIONTECH, 1087204,NV,46.0,F,Complete left ear hearing loss two weeks after vaccine #1,Not Reported,,Not Reported,Not Reported,,Yes,N,01/23/2021,02/09/2021,17.0,WRK,Multi Vitamins and Biotin,"Positive for COVID-19 September 24, 2020",No,,No,"['Acoustic stimulation tests', 'Deafness unilateral']",1,PFIZER\BIONTECH, 1087221,AL,37.0,F,"Flu-like symptoms, stabbing chest pain, dizziness, fatigue, rash, and wheezing that developed around 0930 on 3/9.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/09/2021,1.0,PHM,Dessicated Thyroid 15mg PO Daily; fish oil PO daily; multivitamin PO daily; probiotic PO daily; Vitamin C PO daily,,hypothyroid; endometriosis,,Cipro - Hives Doxycycline - N/V Eggs - N/V Gluten sensitivity,"['Chest pain', 'Dizziness', 'Fatigue', 'Influenza like illness', 'Rash', 'Wheezing']",1,JANSSEN,IM 1087234,IN,53.0,M,Joint pain in elbow and wrist paralysis in fingers,Not Reported,,Not Reported,Not Reported,,Yes,N,03/01/2021,03/03/2021,2.0,OTH,Amlodipine velphoro metoprolol lokalma,ESRD with Dialysis,ESRD,,IVP dye Lasix,"['Arthralgia', 'Paralysis']",1,MODERNA,IM 1087235,TX,44.0,F,caused lymphodema on my right side. Lymph nodes removed in 2019 during unilateral masectomy,Not Reported,,Not Reported,Not Reported,,Yes,N,02/10/2021,02/11/2021,1.0,PUB,Albueterol inhaler,Na,Asthma Breast cancer in remission,,"coconut, antibiotics made with sulfa like bactrum",['Lymphoedema'],1,MODERNA,SYR 1087236,MN,24.0,M,"Fever (101f), body aches all over, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/10/2021,1.0,UNK,,,Pots Eds hyper mobility Possibly marfan syndrome,,,"['Pain', 'Pyrexia']",1,JANSSEN,IM 1087237,MD,53.0,F,"9 hours after shot - Sudden on set chills. and shaking that lasted for more than hour. Followed by vomiting and headache. Headache continued through night. Next 2 days I had fatigue and nausea. Mid day on March 8, I developed swollen bottom lip and on morning of March 9 had hives under lower lip, chin, neck and itchy feeling on neck and face.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,OTH,,,,,,"['Chills', 'Fatigue', 'Headache', 'Lip swelling', 'Nausea', 'Pruritus', 'Tremor', 'Urticaria', 'Vomiting']",UNK,JANSSEN, 1087243,NY,35.0,F,"Patient developed generalized itchiness and nausea 2 minutes after getting vaccine. She has history of food , sulfa, cipro, fluconazole. No rash/hives. Vital signs BP 134/88, Pulse 108, Resp rate 24. EMS was notified and because one team was out transport 911 had to be called. She received epi pen from POD at 1:10AM in Left lateral thigh. VSS. A few minutes later still reported generalized itching and was given Benadryl 50mg PO tablet. FD paramedics on scene and administered IV benadryl, patient became nauseous and dry heaved. She was transported patient to Hospital in the village.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/10/2021,03/10/2021,0.0,OTH,,,,,,"['Epinephrine', 'Heart rate increased', 'Immediate post-injection reaction', 'Nausea', 'Pruritus', 'Respiratory rate increased', 'Retching']",,JANSSEN,IM 1087244,TX,42.0,F,Continued to have Dizziness Followed (15minutes later) Nervousness Confusion Overall body weakness Continued to experience Sore throat with dehydration in my lips and mouth (happening more quickly than I thought possible) Water (16 ounces) did not reduce the dehydration Cold sweats all over (excessive moisture) Diarrhea did decrease quickly (within 2 hours of vaccine) Was released from work (United Supermarket Deli) at 7:00 pm Got home and immediately laying down Called the hospital Hospital said call the Pharmacy that administered the vaccine Pharmacy was already closed Fell asleep a while later feeling very exhausted,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,PHM,Over-the-counter Antihistamine,,,,Aspirin Codeine,"['Asthenia', 'Cold sweat', 'Confusional state', 'Dehydration', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Nervousness', 'Oropharyngeal pain']",UNK,JANSSEN,SYR 1087247,MD,28.0,M,"Fever (101.8), body aches, chills onset about 8 hours after injection. Treated successfully with nsaid",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/10/2021,1.0,OTH,N/a,N/a,N/a,,N/a,"['Chills', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1087249,LA,55.0,F,"Headache, dizziness, temporary tingling and numbness of lips and loss of smell; foggy brain , inability to complete sentence and thoughts lasting 3-5 hours with slightly slurred speech",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/09/2021,1.0,OTH,None,None,None,,NKDA,"['Anosmia', 'Bradyphrenia', 'Dizziness', 'Dysarthria', 'Feeling abnormal', 'Headache', 'Hypoaesthesia oral', 'Paraesthesia oral']",1,JANSSEN,SYR 1087253,TX,41.0,M,Extreme chest pain Hard to breath and painful,Not Reported,,Yes,Not Reported,,Not Reported,U,01/15/2021,01/28/2021,13.0,PVT,,,,,,"['Chest pain', 'Dyspnoea', 'Painful respiration']",2,PFIZER\BIONTECH,SYR 1087256,ND,33.0,M,"Pain in injection site, mild fever, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/10/2021,1.0,PHM,"Nexium, multi-vitamin, Claritin",None,"Sleep apnea, GERD",Flu shot,None,"['Injection site pain', 'Nausea', 'Pyrexia']",1,JANSSEN,SYR 1087260,,28.0,M,"Fever, chills, tired, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/10/2021,03/10/2021,0.0,MIL,,,,Flu shot,,"['Chills', 'Fatigue', 'Headache', 'Pyrexia']",1,JANSSEN,IM 1087261,WI,34.0,F,"Fever of 102, chills, aches, minor heart racing, injection site pain, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,PUB,"Lorazepam prn, ERIN birth control",None,"Central post stroke pain syndrome, anxiety",,None,"['Chills', 'Headache', 'Injection site pain', 'Pain', 'Palpitations', 'Pyrexia']",1,JANSSEN,SYR 1087262,FL,35.0,F,Strong headache; cold feet,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/10/2021,1.0,UNK,,,,Mild symptoms after yearly flu shots,,"['Headache', 'Peripheral coldness']",1,JANSSEN,IM 1087264,TX,43.0,F,Fatigue swelling of face Shortness of breath Cough Joint pain Headache Chest pain dizziness,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,03/05/2021,03/01/2021,,PUB,"zoloft, Metformin ,Cholesterol-lowering medications.Gabapentin ,atorvastatin",,Asthma Diabetes Diabetic neuropathy heart,,No food Sulfamethoxazole,"['Arthralgia', 'Blood test', 'Cardiovascular evaluation', 'Chest pain', 'Cough', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Headache', 'Swelling face']",1,PFIZER\BIONTECH,SYR 1087278,NY,24.0,F,"After patient was vaccinated, she stood up and had loss of consciousness, falling backwards onto floor and +hit back of her head. She does report history of syncope after injections. BP 96/58, P48, R17, O2=98%. Alert and oriented. No deformity. Moving all extremities. Denies headache, nausea. She was on stretcher and after 15 minutes felt better.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/10/2021,03/10/2021,0.0,OTH,,,,,,"['Blood pressure decreased', 'Fall', 'Head injury', 'Heart rate decreased', 'Loss of consciousness']",,JANSSEN,IM 1087279,MD,52.0,F,Fever: 100.4 Chills Headache Fatigue Body aches Treatment: OTC/naproxen,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/10/2021,1.0,PVT,Naproxen 200mg,none,Graves Disease,,"Amoxicillin, Sulfa","['Chills', 'Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1087282,FL,51.0,F,"Fever of 101.6, chills, body aches, back ache, head ache, diarrhea, ear ache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,OTH,none,none,crohns disease,,none,"['Back pain', 'Chills', 'Diarrhoea', 'Ear pain', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1087283,CT,40.0,F,"Chills, body aches and fever about 7 hours after the shot. I took Tylenol and it made the symptoms more mild. I was fever free at about 11am the next day. My injection site and arm still hurts 3 days later and I have a swollen and sore gland in my collar bone on the same side as my shot was given.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/07/2021,0.0,PVT,"Levothroxine. Birth control, multi vitrine, b12 and iron",,Hashimoto,,Bacitracin and hydrocortisone neosporene,"['Chills', 'Injection site pain', 'Lymph node pain', 'Lymphadenopathy', 'Pain', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,SYR 1087308,PA,92.0,F,"her mother didn't want anything to eat; her mother wasn't making any sense when she talked; Dizzy; Weakness; shaky; stomach became upset; her mother had a pretty severe headache come on; Nose bleeds; Blood pressure increased; her mother's comprehension is not at the same level as prior to being hospitalized; This is a spontaneous report from a contactable consumer. A 92-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 15Feb2021 12:30 at SINGLE DOSE for covid-19 immunisation. Medical history included blood pressure high, high cholesterol. Caller stated her mother has had high blood pressure for around 15 years. She said her mother's blood pressure medicine has changed over the years, providing her current blood pressure medication as: Ramipril 2.5mg capsule, once a day, Bisoprolol 5mg tablet, once a day. Reported her mother has had high cholesterol for at least 30 years. She said her mother's cholesterol is controlled with Simvastatin 40 mg, once a day. She said her mother has been on Simvastatin for at least 10 years and her mother's Simvastatin dose has been bumped up gradually over that time. She said the Simvastatin 40mg is dispensed in a pharmacy bottle with no NDC, Lot, and expiration date. Concomitant medication included omeprazole (OMEPRAZOLE), simvastatin (SIMVASTATIN) for high cholesterol, ramipril (RAMIPRIL) for blood pressure high, bisoprolol (BISOPROLOL) for blood pressure high. The patient experienced nose bleeds on 18Feb2021 with outcome of recovered on 22Feb2021, her mother had a pretty severe headache come on on 18Feb2021 with outcome of not recovered, blood pressure increased on 18Feb2021 with outcome of recovering, dizzy on 20Feb2021 with outcome of unknown, weakness on 20Feb2021 with outcome of not recovered, shaky on 20Feb2021 with outcome of unknown, stomach became upset on 20Feb2020 with outcome unknown, her mother didn't want anything to eat on 21Feb2021 with outcome of unknown, her mother wasn't making any sense when she talked on 21Feb2021 with outcome of not recovered, her mother's comprehension is not at the same level as prior to being hospitalized on an unknown date with outcome unknown. The patient was hospitalized from 21Feb2021 to an unknown date. Reporting on her 92 years old mother who received her first Pfizer COVID-19 Vaccine dose last Monday, 15Feb2021. She said the first couple days her mother was fine after receiving the COVID-19 Vaccine. She said on Thursday, 18Feb2021, her mother had a pretty severe headache come on. She said her mother normally doesn't have headaches. She said her mother began having nose bleeds that started on Thursday (18Feb2021), and continued on Friday (19Feb2021), and Saturday (20Feb2021). She said her mother's blood pressure was up during that time, as well. She said on Saturday night (20Feb2021) at 9:00 PM she took her mother to the Emergency Room because her mother's blood pressure was very high. She said a CT scan of her mother's head was done and was negative for a stroke. She said her mother was kept in the Emergency Room and monitored. She said her mother's blood pressure was gotten under control with given blood pressure lowering medication in the Emergency Room and her mother was discharged home at around midnight. She said she does not know the name, dose, NDC, Lot, and Expiration Date for the blood pressure medication. Reported her mother takes Warfarin for blood clots. She clarified her mother is monitored monthly and her mother's Warfarin is adjusted accordingly. She said her mother takes a Warfarin 1mg tablet daily on Monday through Friday, and a 1/2 Warfarin 1mg tablet (0.5mg) on Saturday and Sunday. She said the Warfarin is dispensed in a pharmacy bottle with no NDC, Lot, and Expiration Date. She said her mother has been on Warfarin for around 20 years, since her mother had a blood clot. Reported her mother takes a stomach medication, clarified as Omeprazole 20mg capsule once a day. She said her mother has been on Omeprazole for years. She said the Omeprazole 20mg capsule was dispensed in a pharmacy bottle with no NDC, Lot and Expiration Date. She said her mother's stomach had been fine. She said her mother didn't get sick to her stomach, until the night she was released from the Emergency Room (20Feb2021). She said when her mother sat up and tried to stand while she was in the Emergency Room on Saturday night (20Feb2021), her mother was dizzy, and felt weak and shaky. She said her mother was given some orange juice and peanut butter crackers at the time. She said her mother's stomach became upset then. She said she thinks her mother's stomach upset had more to do with having the orange juice and peanut butter crackers than anything else. She said her mother has never had nose bleeds or headaches before. She said her mother has blood pressure issues that she takes blood pressure medicine for. She said she thinks the COVID-19 Vaccine may have exasperated her mother's issues. Reported on Sunday (21Feb2021), her mother didn't seem much better to her. She said her mother's blood pressure was up, her mother was dizzy, weak and had a bad headache. She said her mother has a healthy appetite for 92 years old and her mother didn't want anything to eat. She said she ended up calling 911 because her mother wasn't making any sense when she talked. She clarified her mother was picked up by the ambulance at 9:00PM on Sunday (21Feb2021); and admitted to the hospital. She said her mother is still in the hospital as of today, Tuesday, 23Feb2021. She said her mother had a CT scan, a MRI, and an EEG. She said the CT scan, and MRI were negative, and the EEG results were not back yet. She said her mother may be released home today, 23Feb2021, depending on the EEG results. Reported her mother has never had nose bleeds or headaches before. Reported on Sunday, 21Feb2021, she took her mother's blood pressure. She said her mother was very weak and incoherent. She said her mother was unable to comprehend the way she usually does. Reported her mother has had no more nose bleeds since yesterday 22Feb2021. She said her mother is still quite weak, but her blood pressure is now under control. She said her mother has been on a stroke watch while at the hospital, and her mother has not been allowed to get up out of bed as of last night (21Feb2021). She said the hospital staff are supposed to let her mother walk today (23Feb2021) to see if her mother's blood pressure stays stabilized. She said her mother's comprehension is not at the same level as prior to being hospitalized. She clarified her mother still drives a car at 92 years old and takes care of her own check book. She said she doesn't know if her mother will still be able to do that at this time. Reported her mother was checked for a UTI while at the hospital. She said the hospital went ahead and treated her mother for a UTI without knowing if her mother had a UTI. She said because her mother is elderly, a lot of times the elderly have UTIs. She said the hospital didn't want to waste time and went ahead and treated her mother for a UTI because her mother hadn't been on antibiotics recently. The caller stated she did not have any information on the medications her mother has been given while at the hospital. Reported at first she did not think her mother's symptoms had to do with her mother's first COVID-19 Vaccine dose, but then there was a new part to her mother's story that made her think her mother's symptoms had to do with the COVID-19 Vaccine. Caller stated she is apprehensive for her mother to go get her second COVID-19 Vaccine shot. The patient underwent lab tests and procedures which included blood pressure abnormal: up on 18Feb2021, Head CT: negative on Feb2021, Head CT: negative for stroke on 20Feb2021, EEG: unknown results on Feb2021, MRI brain: negative on Feb2021. Therapeutic measures were taken as a result of nose bleeds, blood pressure increased, dizzy, weakness, shaky.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/15/2021,02/18/2021,3.0,PVT,OMEPRAZOLE; SIMVASTATIN; RAMIPRIL; BISOPROLOL,,Medical History/Concurrent Conditions: Blood pressure high; High cholesterol,,,"['Abdominal discomfort', 'Asthenia', 'Blood pressure increased', 'Blood pressure measurement', 'Computerised tomogram head', 'Decreased appetite', 'Dizziness', 'Electroencephalogram', 'Epistaxis', 'Headache', 'Incoherent', 'Magnetic resonance imaging head', 'Mental impairment', 'Tremor']",1,PFIZER\BIONTECH, 1087310,NY,28.0,F,"Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient was extremely anxious when she came in for vaccine informing vaccinator that this was her second appointment because she had cancelled the first appointment due to anxiety of side effects (was worried she \""was going to die\""). She stated that her mouth was slightly numb/itchy and that for a moment it was her whole body. Then stated that her mouth had become dry from being anxious about the vaccine. After giving a dose of diphenhydramine & getting the patient to calm down the rxn subsided",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PHM,,,,,,"['Anxiety', 'Dry mouth', 'Hyperventilation', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Pruritus']",1,JANSSEN,IM 1087312,VA,80.0,F,"extreme pain in joints particularly left arm, elbow, hand, shoulder . Pain throughout rest of body, so debilitating that I could hardly walk. Need to use walker ever since",Not Reported,,Not Reported,Not Reported,,Yes,N,02/13/2021,02/17/2021,4.0,PHM,"aspirin, lovastatin, vitamin d, vitamin c",none,,,sulfa,"['Arthralgia', 'Gait disturbance', 'Pain', 'Pain in extremity', 'Walking aid user']",UNK,MODERNA,IM 1087313,NJ,46.0,F,"Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,PHM,,,,,,"['Paraesthesia', 'Pruritus']",1,JANSSEN,IM 1087315,CA,29.0,F,"Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt was escorted to waiting area and sat in chair. Within 5 mins of sitting down, pt's head fell backwards and hit the wall behind her slightly, slipped out of the chair and fell on floor. Pt got up as soon as she was on the floor. The incident transpired in less than one minute and she regained consciousness. Pt was given water and said she felt \"" the blood rushing back\"" and felt \""much better\"". Had pt stay around for > 30 minutes and was picked up by friend. Per pt, she was not hurt",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PHM,,,,,,"['Fall', 'Syncope']",1,JANSSEN,IM 1087316,PA,65.0,M,"Roughly 6 hours after the shot I started feeling side effects which included; achy joints, low fever, mild headache, tired and run down like I was getting a cold. The symptoms laster through the night and into this morning when I woke up feeling a bit better. It's been 13 hours since the first side effects and at this point I feel run down but most of the other symptoms have subsided.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PHM,Dextroamp 15mg once per day (ADD meds) Rosuvastatin calcium 5mg 1 per day Zyrtec 10mg once a day every 3 or 4 days as needed,None at time of vaccination. Three weeks prior I had a cold but was tested for COVID twice 5 days apart and both text were negative.,none,,Sulfa,"['Arthralgia', 'Fatigue', 'Headache', 'Pyrexia']",UNK,JANSSEN,SYR 1087317,CA,29.0,M,"Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild, Additional Details: Patient alerted me that he was feeling unwell, he started hyperventilating, sweating, shaking, experiencing tingling and numbness throughout his body. Patient was dizziness. He received an epinephrine shot in which he then layed on the floor and started calming down. Paramedics came and checked him out and found him to be alert and well. Patient left store fully recoverd and consulted to go to emergency room if he had any symptoms of an analyphylatic reacction.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PHM,,,,,,"['Dizziness', 'Hyperhidrosis', 'Hyperventilation', 'Hypoaesthesia', 'Malaise', 'Paraesthesia', 'Tremor']",1,JANSSEN,IM 1087318,MN,37.0,M,Chills and a 102 degree fever for at least 8 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PVT,None,None,None,,None,"['Chills', 'Pyrexia']",1,JANSSEN,SYR 1087321,NY,26.0,F,"Syncope after getting vaccine. BP 95/60, P 100, O2sat 96%. Improved after 2 minutes but monitored for 20 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/09/2021,03/09/2021,0.0,OTH,,,,,,"['Hypotension', 'Syncope']",,JANSSEN,IM 1087322,FL,26.0,F,"Janssen COVID-19 Vaccine EUA Six hours after I received the vaccine I began to feel full body muscle aches and shivers. I took 2 Advil. I went to bed at 9:30 p.m. and woke up at 11:30 p.m. feeling as though I had slept 8 hours because I had a 102 fever. My face was burning from the heat and I was shaking. I took two more Advil. About 30 minutes later I threw up. I waited 30 more minutes and threw up again. As a result, of having Addison's disease, I have an emergency steroid injection that I use during crises such as this. I took my shot and immediately began feeling slightly better. I was able to go back to bed and at some point the fever went down overnight. I am currently feeling weak and with no fever. I also have a slight headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,OTH,hydrocortisone and fludrocortisone,"general allergies to the environment, like pollen, etc.",Addison's adrenal insufficiency,,none,"['Asthenia', 'Burning sensation', 'Chills', 'Headache', 'Myalgia', 'Pain', 'Pyrexia', 'Tremor', 'Vomiting']",1,JANSSEN,IM 1087324,FL,29.0,F,1:20am: woke up with full body chills and felt feverish. Temperature was 99.1 4:30am: woke up with full body chills. Temperature 101.7. full body aches. headache. 6:30am: took ibuprofen. 8:00am-4pm: fever went away. aches and headache remained. 12:00pm: took ibuprofen 4pm: diarrhea 7pm: achy and lethargic. took ibuprofen 8pm: went to bed. 6:00am: woke up sweaty. Felt 99% back to normal. Left arm still sore.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/09/2021,1.0,PHM,Spironolactone Prenatal Vitamins Kyleen IUD,none,Asthma,,none,"['Chills', 'Diarrhoea', 'Headache', 'Hyperhidrosis', 'Lethargy', 'Pain', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,IM 1087330,,85.0,F,"Weakness, headache, pancytopenia 89",Not Reported,,Not Reported,Yes,,Not Reported,N,03/06/2021,03/07/2021,1.0,UNK,,,"HTN, GERD",,,"['Asthenia', 'Headache', 'Pancytopenia', 'Platelet count decreased']",UNK,PFIZER\BIONTECH, 1087332,NY,30.0,F,"Syncope and fell on her hands and knees. No head trauma. No other injuries. BP 110/77, 85, O2 sat 96%. She was observed for 35 minutes. She felt better and went home.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/10/2021,03/10/2021,0.0,OTH,,,,,,"['Fall', 'Syncope']",,JANSSEN,IM 1087337,TX,56.0,F,leg cramp,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/06/2021,03/10/2021,4.0,UNK,"Zinc, Multivitamin",none,none,,none,['Muscle spasms'],1,JANSSEN,IM 1087340,IN,50.0,F,"Fever, chills, shivering, whole body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PHM,"Multivitamin, vit D,",allergies,"post-treatment lyme disorder, auto-immune","Shingrex, shivers, hives, fever, body soreness, age 50","High intolerance to egg whites & macadamia nuts, no known food allergies tho. Allergies to all grasses and most trees - seems unnecessary to mention tho now that I did.","['Chills', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1087345,IN,50.0,F,Chills Fatigue Headache Muscle aches Loss of appetite,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,Sprinolactone,None,None,,None,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Myalgia']",1,JANSSEN,SYR 1087349,IA,29.0,M,Muscle soreness and fatigue. Starting at around 6:00 last night and continuing into today. Took Tylenol to reduce pain and soreness.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,WRK,,,,,penicillin,"['Fatigue', 'Myalgia']",1,JANSSEN,IM 1087351,OH,22.0,F,"Muscle pain all over body, specifically glutes, lower back back, and arms. Fever above 99� F Chills and sweats at the same time Headache with pulsating nerve pain on sides and ears. Dryness in mouth no matter how much water intaked Treatment: tylenol and bed rest",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,PUB,Clonazepam . 5 mg Sertraline 100 mg Fish oil D3 Women's multivitamin St. Johns Wort,None,,,Allergic to omnicef (ceftiner),"['Chills', 'Dry mouth', 'Hyperhidrosis', 'Myalgia', 'Neuralgia', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1087371,CT,57.0,M,100 fever Severe aches pain Headaches Happened 12 am,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/10/2021,1.0,PHM,T1 diabetic for 52 years. Using Insulin pump Humalog. Simvastatin Levoxyl Levothyroxine Flomax Baby aspirin Vitamin D Vitamin C Turmeric,None,T1 Diabetes Hashimotos High BP Hypertension Prostate,,No allergies,"['Headache', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1087376,MI,30.0,F,"Janssen COVID-19 Vaccine EUA headache, fever, chills, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/10/2021,1.0,PVT,Apri birth control,,,,Bactrim,"['Chills', 'Headache', 'Nausea', 'Pyrexia']",1,JANSSEN,IM 1087389,OH,63.0,F,"In the evening I started to feel aches in my eyes and joints. I was having trouble falling asleep. I woke up every 2 hours. My heart bpm went up to 102 in the middle of the night. I know this because my fit bit was vibrating and encouraging me to keep exercising and I was just laying in bed trying to sleep. I finally got up around 2:30 in the morning and took 1 Aleve. I also took my temperature with a forehead type and it was 98.5, so no high fever. I took another Aleve around 7:00 in the morning. Now I am feeling fine. It's now 8:22 a.m. and I am working from home. I just wanted to report that the aches in joints and 102 bpm and unable to fall asleep were my side effects. I feel fine now. I will continue to take Aleve as needed. I have never been tested for Covid. I have never had any symptoms to warrant testing for covid. Since March 13, 2020 I have been fortunate to work for a company that has us all working from home. We are still working from home. i am 63 years old. I shop around 6 a.m. in the morning for groceries to avoid people. I do not go out. I have been very careful.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PUB,"Metformin er 500mg simvastatin 20mg hydrochlorothiazide 12.5mg low dose aspirin, b complex, d3, zinc",none,"pre-diabetes, controlled with meds high cholesterol, controlled with meds",,none,"['Arthralgia', 'Eye pain', 'Heart rate increased', 'Insomnia']",UNK,JANSSEN, 1087390,CT,28.0,F,"Fever, shakes, severe body aches and sharp pains throughout my body. Nausea and vomiting and constant use of the bathroom. Dizziness, and severe migraine, fatigue and trouble breathing that lasted 2+ hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,SCH,None,None,Heart defects - repaired Seizure disorder - no longer taking medications as this has been resolved Familial Penicillin and Cefzil allergies,,Cefcil,"['Dizziness', 'Dyspnoea', 'Fatigue', 'Migraine', 'Nausea', 'Pain', 'Pyrexia', 'Tremor', 'Vomiting']",1,JANSSEN,SYR 1087396,NY,61.0,F,Severe headache pain in the eyes a lot of pain in the body breast pain the arm swollen and red nausea,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,OTH,"Janumet ,rubostatin 40 lisinopril , e omoprazol",Bladder infection,Type 2 diabetes high blood pressure high cholesterol diseases of the bones herniated disc,,None,"['Chest pain', 'Eye pain', 'Headache', 'Nausea', 'Pain', 'Peripheral swelling']",1,JANSSEN,SYR 1087398,TX,41.0,F,"Woke up with a severe headache, threw up, had chil. A rash on my neck developed that was red, itchy, and scaly and has persisted for 4 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,PHM,Adderall XR,none,KTS,,none,"['Chills', 'Headache', 'Rash', 'Rash erythematous', 'Rash pruritic', 'Skin exfoliation', 'Vomiting']",UNK,JANSSEN, 1087407,NY,18.0,M,"Fever, chills, numbness and tingling of face, weakness, headache, sore throat, rapid heart rate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,PVT,,,,,,"['Asthenia', 'Chills', 'Headache', 'Heart rate increased', 'Hypoaesthesia', 'Oropharyngeal pain', 'Paraesthesia', 'Pyrexia']",1,JANSSEN,IM 1087409,CT,34.0,M,"Fever (101 degree), headache, muscle aches, chills. Treated with tylenol and rest. So far it seems to be helping.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,SCH,"300mg Allopurinol, 2.5mg lisinopril, 300mg gabapentin, 100mg sertraline, 100mg minocycline, 50,000 units vitamin d",,"Gout, hypertension","Flu shots and tetanus vaccines multiple times. Reaction is usually 2-5 days of varying symptoms like fever, aches, chills.",None known,"['Chills', 'Headache', 'Myalgia', 'Pyrexia']",1,JANSSEN,SYR 1087411,FL,40.0,F,"Janssen COVID-19 Vaccine EUA About 6 hours after receiving vaccine, sudden onset of fever to 101 degrees with chills. About two hours after the fever began, extreme fatigue and muscle and joint pain, and left breast pain began (had the injection in my left arm). The extreme fatigue lasted for about 9 hours, during which time I felt like I could barely walk or move in bed. After the extreme fatigue passed, and for about 24 hours, I continued to experience moderate fatigue, joint and muscle pain, and headaches. A bad headache has bothered me for about 36 hours since the extreme fatigue passed. All symptoms are now clearing up (it is now about 42 hours post vaccination).",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/08/2021,0.0,UNK,Allegra 24 hr (180 mg),,,,,"['Arthralgia', 'Breast pain', 'Chills', 'Fatigue', 'Headache', 'Myalgia', 'Pyrexia']",1,JANSSEN,IM 1087416,VA,22.0,F,"Janssen COVID-19 Vaccine EUA Nausea, headache, fever, muscle soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,PHM,"None, but i took some ibuprofen around 9pm that night",None,None,,None,"['Headache', 'Myalgia', 'Nausea', 'Pyrexia']",1,JANSSEN,IM 1087418,OH,50.0,F,"WITHIN 5 MINUTES OF RECEIVING VACCINE PATIENT BEGAN FEELING VERY LIGHTHEADED, SWEATING, AND SPINNING. PATIENT SAID SHE NEEDED TO LAY DOWN. AS WE BEGAN LAYING HER DOWN SHE DID PASS OUT. AFTER LAYING ON THE GROUND WITH ELEVATED LEGS SHE REGAINED CONCIOUSNESS WITHIN ABOUT 30 SECONDS OR SO. PATIENT CONTINUED TO LAY AND THEN SLOWLY SIT UP. AFTER APROX 20 TO 30 MINUTES SHE WAS FEELING OK AND WAS ABLE TO GO HOME",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PHM,UNKNOWN,UNKNOWN,NONE,,NKDA,"['Dizziness', 'Hyperhidrosis', 'Immediate post-injection reaction', 'Loss of consciousness', 'Vertigo']",1,JANSSEN,IM 1087422,MN,29.0,F,"Chills, tiredness, muscle aches, fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,MIL,None,None,None,,None,"['Chills', 'Fatigue', 'Myalgia', 'Pyrexia']",1,JANSSEN,SYR 1087423,AZ,55.0,M,"About 9:00 PM got chills. Finally broke around midnight and after that was hot and achy. Today body aches, head ache, and eyes hurt. This is a similar reaction to what I have with the flu vaccine. I no longer get the flu vaccine because of this.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,SCH,"Vitamins C, D, and B Complex",None,High blood pressure,"Similar reaction to flu vaccine, last one was over 30 years ago",Penicillin,"['Chills', 'Eye pain', 'Feeling hot', 'Headache', 'Pain', 'Reaction to previous exposure to any vaccine']",1,JANSSEN, 1087428,OH,89.0,M,"Documentation in death summary noted patient expired 2/11/21. Clinical diagnosis; respiratory failure due to pneumonia, GI bleed due to duodenal bulb ulcer, renal failure, uncontrolled atrial fibrillation, protein calorie malnutrition, community acquired pneumonia. SARS-COVID-19 not detected per documentation found on DNA molecular diagnostics laboratory report collected 2/2/21. Patient had received covid vaccination 1/29/21 prior to arrival at ED on 2/1/21. No documentation found of which brand or dose number patient had received. No lot number available for documentation.",Yes,02/11/2021,Not Reported,Yes,,Not Reported,N,01/29/2021,02/01/2021,3.0,PVT,"tiotropium bromide inhalation, fluticasone furoate =-vilanterol inhalation, albuterol sulfate inhalation, metoprolol tartrate, furosemide, digoxin, doxazosin, finasteride, tamsulosin, warfarin, allopurinol, levothyroxine","GI bleed, Hgb 7.1 supratherapeutic INR","Chronic conditions chronic hypoxemic respiratory failure, chronic atrial fibrillation on Coumadin, hypothyroidism, GERD, gout and celiac disease.",,NKDA,"['Atrial fibrillation', 'Duodenal ulcer', 'Gastrointestinal haemorrhage', 'Malnutrition', 'Pneumonia', 'Renal failure', 'Respiratory failure', 'SARS-CoV-2 test negative']",UNK,UNKNOWN MANUFACTURER, 1087429,IN,59.0,M,"About 36 hours after the injection (Sunday 3/9 8:00am), I started getting a headache mostly at the base of my skull. It got progressively worse and spread to the front of my head too. By that evening (Sunday 3/9) it was throbbing like one of the worst headaches I have had. Monday was so bad that I called in and didn't work. Tuesday 3/9 was still bad. Finally, Tuesday night is started letting up and was able to sleep. I still have a little headache at the back of my head, 9:00am 3/10. Also, I couldn't sleep Sunday 3/8 and Monday 3/9 night . I had a Tylenol 3 prescription and used it. I was taking 2 at a time and it was not helping much. Also mixed in some ibuprofen.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/07/2021,2.0,UNK,"Levothyroxine 150mcg, Nortryptiline 25mg, Benadryl, Fluticasone nose spray",Nothing,"Low thyroid, some pollen and mold airborne allergies.",,penicillin,['Headache'],1,JANSSEN,IM 1087434,,23.0,F,"Severe headache (to the point where it was affecting my vision), dehydration, sweats and chills as though I had a fever, muscle aches, and difficulty sleeping. All of these symptoms lasted for approximately 9 hours. They started 10 hours after the vaccine itself.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/10/2021,1.0,UNK,Oral birth control Pills,,,,Allergic to kiwis (if consumed).,"['Chills', 'Dehydration', 'Headache', 'Hyperhidrosis', 'Insomnia', 'Myalgia', 'Visual impairment']",1,JANSSEN,SYR 1087441,NE,48.0,F,headache for ~15hours body aches for ~15 hours fever 100.1 - 7 hours,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,WRK,Simvastatin 10 mg,,,,,"['Headache', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1087445,CT,53.0,F,"5:30AM (time I got up) Injection site soreness and stiffness, headache and body aches (skin sensitivity). Took Ibprophen and hot shower; symptoms subsided in about 30 to 60 minutes.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/10/2021,1.0,SCH,"Omeprazole, Estroven, Bioten gummies","None. COVID-19 positive January 18, 2021",None,,None,"['Headache', 'Injection site pain', 'Musculoskeletal stiffness', 'Pain', 'Skin sensitisation']",1,JANSSEN,SYR 1087448,,50.0,M,Headache. Low grade fever. Body aches. Exhaustion. Started 24 hours after shot. And lasted less than 24 hours. Symptoms are totally gone now.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,PVT,Lomotil. Xanax. metoprol tartrate. Lisinopril Allupuranol. Vitamin b212. Vitamin d3. hydrochlorothiazide. Trazadone. Lexapro.,,Kidney disease Crohn?s disease,,None known,"['Fatigue', 'Headache', 'Pain', 'Pyrexia']",UNK,JANSSEN,SYR 1087449,FL,58.0,F,"Received my Covid shot yesterday at a Mall Testing Site.About 8pm I began having severe chills. I went to bed at 9:30pm, woke up at 1:00am and took some Motrin. This morning at 6:40 am I still had chills so I took my temperature and it was 100.0 degrees. It has remained 100 degrees this morning. I took some more Motrin. My right arm is also sore at injection site.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/10/2021,1.0,OTH,"Zinc, D-3, Vit C, Magnesium, Multi-vit",Non at time of vacination. Tested positive for covid in early February.,NONE,,"Niacin, Oxycodone, Hydrocodon, Venlaflaxine","['Body temperature increased', 'Chills', 'Injection site pain']",1,JANSSEN,IM 1087450,FL,41.0,F,"After 7 hours, I started to feel like I had a migraine. Then my whole body ached horribly, I had chills, a fever, difficulty breathing",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,PHM,Multi-vitamin,None,None,,"sulfa, penicillin, latex, epinephrine","['Chills', 'Dyspnoea', 'Migraine', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1087453,NJ,37.0,M,"At 5p, started to get a headache and body aches. By 6p, fever was 99.5. At 8p, fever was 101. The rest of the night featured a headache, body aches, chills, fever of 100.5 to 102.5 and nauseated (dry heaved twice) Took tylonel every 6 hours to try and help. Next morning (current as of writing this), felt a little better as fever dropped to 99.5 and nausea significantly lowered. Still have a headache and aches in legs",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/09/2021,03/09/2021,0.0,PHM,,,,,,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",UNK,JANSSEN,SYR 1087456,FL,62.0,F,"A 63-year-old female with a medical history of Hashimoto?s Disease, on Levothyroxine 88 micrograms (4 days per week) and 100 micrograms (3 days per week), presented to the emergency department with a 7-day history of acute onset of severe, debilitating, fatigue, weakness, anorexia and malaise. She had no clear precipitating events, stated that she was in her usual states of health, active, working as an optometrist at a University hospital. Stated that 1 week before symptom oncer she had her first dose of Moderna COVID-19 Vaccine EUA. Stated that 24hrs later her symptoms started associated with low grade subjective fever, however her fever disappeared, and she persisted with severe fatigue. She was unable to do her regular activities of daily living and was hoping her symptoms would resolve but upon persistence and given the severity of her complains she presented to evaluation. She denied recently starting any new medications/supplements, or recent change in her levothyroxine dose. There were no headaches, cough, diarrhea, sore throat, rhinorrhea, myalgia, arthralgia, weakness, recent infectious illness or sick contacts. She was diagnosed with Hashimoto?s Disease over 10 years prior and had been on the same dose for more than 2 years. VS were stable and within normal limits, physical exam was only remarkable for weakness on 4 extremities 4/5, lethargy, bradylalia, bilateral ptosis, no focal neurologic deficits, sensation intact. Laboratory workup revealed normal Hb 14.8, normal renal and kidney function, normal cortisol level, TSH normal 3.7, normal FT4: 1.2, normal CPK, negative tox screen. ESR and CRP were performed, and both were found to be elevated ESR 74, CRP 28, at that moment we decided to do immunologic workup showing high titers of ANA >1:320 with a nuclear speckled pattern, and a positive rheumatoid factor 60. At this point a full rheumatologic panel was performed which was negative for anti-Ach receptor Abs, negative anti-CCP, anti- dsDNA, anti-smith, negative anti-Jo1, anti-RNP, negative anti-TPO, negative anti-SCL70, normal C4 and C3 however elevated total CH50 > 60, positive anti-SSA and anti-SSB. Her symptoms of severe fatigue persisted throughout her admission and it was decided to give her a course of prednisone 40mg for 5 days and follow up as outpatient with a Rheumatologist. Repeat workup 2 weeks after discharge showed still elevated ESR at 72, high CRP 17, rheum factor elevated again at 67. At this point no clear cause was identified as she did not have any symptoms of Sjogren or anything else other than severe persisting fatigue. Another course of steroids was given and 1 month later she stated that she was much improved and was able to go back to work. Stated that she would not take her second covid MODERNA vaccine dose due to fear of recurrence of symptoms. It appeared that this vaccine triggered a severe inflammatory and autoimmune reaction in this patient with history of Hashimoto?s disease. The association between MODERNA vaccine and development of autoimmunity and inflammatory reaction needs to be assessed.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,01/02/2021,01/04/2021,2.0,PVT,levothyroxine 88mcg QD,hypothyroidism,hypothyroidism,,none,"['Anti-cyclic citrullinated peptide antibody negative', 'Antiacetylcholine receptor antibody', 'Antinuclear antibody', 'Antinuclear antibody increased', 'Antinuclear antibody negative', 'Antinuclear antibody positive', 'Asthenia', 'Autoimmune disorder', 'Blood creatine phosphokinase normal', 'Blood thyroid stimulating hormone normal', 'C-reactive protein increased', 'Complement factor C3', 'Complement factor C4', 'Cortisol normal', 'Decreased appetite', 'Double stranded DNA antibody', 'Eyelid ptosis', 'Fatigue', 'Haemoglobin normal', 'Impaired work ability', 'Inflammation', 'Lethargy', 'Loss of personal independence in daily activities', 'Malaise', 'Pyrexia', 'Red blood cell sedimentation rate increased', 'Renal function test normal', 'Rheumatoid factor positive', 'Rheumatological examination', 'Slow speech', 'Thyroid function test normal', 'Thyroxine free normal', 'Total complement activity increased', 'Toxicologic test normal']",UNK,MODERNA,IM 1087457,NY,30.0,F,Fever Chills Sweats Light arm pain Headache Horrible muscle Aches Horrible muscle fatigue Low grade fever while taking extra strength tylenol 99.7 Nauseousness Light headed Tossed and turned all night in such pain and chills and sweats Felt like I was going to pass out on my commute home could barely walk my limbs were so heavy and tired and numb,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,OTH,Birth control Levoxyl,,Graves disease Hypo thyroidism,,Lactose intolerant,"['Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Hypoaesthesia', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,SYR 1087458,IN,50.0,F,"At 4pm I spoke a fever and chills- lasted until 2am. Skin had spots on left arm, left calf and face that felt like a bad sunburn",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PUB,Taltz and hydrochlorothiazide,None,Psoriasis and high blood pressure,,N/a,"['Chills', 'Pyrexia', 'Rash']",1,JANSSEN,SYR 1087459,IN,38.0,F,"Chills, headache, body ache, start 1am-9pm, took ibuprofen",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/09/2021,1.0,PVT,Methylphenidate LA 20mg,,"M.S, eczema, and narcolepsy",,fish and latex,"['Chills', 'Headache', 'Pain']",1,JANSSEN,SYR 1087482,IL,62.0,F,"Headache, fatigue, loss appetite, light head,",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/08/2021,1.0,SCH,"Medication for high blood pressure, vitamin d and vitamin c",,High blood pressure,,Latex,"['Decreased appetite', 'Dizziness', 'Fatigue', 'Headache']",1,JANSSEN,SYR 1087489,IN,51.0,F,I had a pretty bad reaction to the shot got the shakes and aches was up and down about every 20 minutes head was pounding felt like my brain was on fire fever finally broke about 6am next morning woke up totally drenched and sweat,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,UNK,,,,,,"['Adverse reaction', 'Headache', 'Pain', 'Tremor']",UNK,JANSSEN,SYR 1087491,TX,42.0,F,"Chest tightness/pain, headache, body aches, rash, fever and chills",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/08/2021,0.0,PHM,"Snythroid, melatonin and spirolactane",None,Hypothyroidism,,No,"['Chest discomfort', 'Chest pain', 'Chills', 'Headache', 'Pain', 'Pyrexia', 'Rash']",UNK,JANSSEN, 1087494,IA,26.0,F,"Severe joint pain, severe muscle pain, fever 100.5, swelling in joints, and headache started at around 2pm of the same day of vaccination and continued into the night. Took 600mg of ibuprofen every 4 hours to control pain. After second round of ibuprofen pain was tolerable. Day 2: when going off of ibuprofen severe pain returns with limited mobility again. Will continue ibuprofen for day 2.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PHM,"Methotrexate, Singulair, Omeprozole, Norethindrone, Carbinoxamine, multivitamin.",,Inflammatory arthritis,,"Sulfa, Gluten, Lactose, Latex","['Arthralgia', 'Headache', 'Joint swelling', 'Mobility decreased', 'Myalgia', 'Pyrexia']",1,JANSSEN,SYR 1087499,IN,51.0,M,"Headache, Fever (100.2), severe chills, severe body aches starting 12 hours after injection. Severe symptoms lasted 8 hours. Ibuprofen lessened symptoms. Symptoms gone 48 hours after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,none,none,none,,none,"['Chills', 'Headache', 'Pain', 'Pyrexia']",UNK,JANSSEN,SYR 1087500,IN,53.0,M,High fever 102.3 following morning with significant body aches,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/09/2021,1.0,OTH,"Tramadol, Synthroid, pantropazol, Gabapentin,",,Peripheral neuropathy,,,"['Pain', 'Pyrexia']",1,JANSSEN,SYR 1087509,CT,36.0,F,"Received shot at 2:15 pm and around 9:30 pm, I started to have the chills/shaking. It then went between chills to sweating profusely. I took Advil before going to bed. I have a slight heading now (9:00 am, 3/10/21).",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/09/2021,03/09/2021,0.0,PVT,"Levothyroxine, Bupropion, Birth control, fish oil, Vitamin D and B12.",Tension headaches (prior),High cholesterol Thyroid issue Generalized anxiety,,NKA,"['Chills', 'Headache', 'Hyperhidrosis', 'Tremor']",,JANSSEN,SYR 1087512,UT,24.0,F,Intense body and joint aches all over my body. Fever hovering between 100.3 and 101.2,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,UNK,,,,,,"['Arthralgia', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1087513,IN,51.0,M,Brutal headache day following,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/09/2021,1.0,PHM,Lisinopril 20mg,,,,,['Headache'],UNK,JANSSEN, 1087526,NJ,33.0,F,"I received my second vaccination in the morning on 02-04-21. I visited my OBGYN that afternoon learned that I was approximately seven weeks pregnant, and that my baby was healthy with a heartbeat, I returned to the OBGYN four weeks later for my routine visit and leaned that the fetus had died around week 8, which was approximately one week after receiving the vaccine. I had no other issues or complications that would have contributed to my miscarriage.",Not Reported,,Yes,Yes,1.0,Not Reported,N,02/04/2021,02/01/2021,,PUB,Pre Natal Vitamin,None,None,,Sulfa Drugs,"['Abortion spontaneous', 'Exposure during pregnancy', 'Foetal death', 'Ultrasound antenatal screen abnormal', 'Uterine dilation and curettage']",2,MODERNA,IM 1087528,MN,68.0,F,"all over body aches, extreme exhaustion and headache - tiredness noticed late afternoon - gradual progression to exhaustion - fever of 99.2 in the night and a residual head throb in the morning",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,UNK,"vitamin d3 2000 units, multivitamin, Immune complex including mushrooms, omeprazole 20mg once daily.",none,none,,none,"['Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1087536,IN,52.0,M,"Headache, chills and vomiting twelve hours after my shot. Eight hours later I broke out in hives.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,PVT,Lexipro(generic),None,None,Hives and fever,None,"['Chills', 'Headache', 'Urticaria', 'Vomiting']",UNK,JANSSEN,SYR 1087540,CT,38.0,F,"body pain immediately following vaccine--left side of body--same side as vaccine: neck, sides, hips, back. That ended within a half an hour. Felt ok for a few hours. Headache starting around 2:30. Neck and back pain around 8. Chills, body aches, fever throughout the night and into the next day. Chills subsided. Body aches continued. Side/rib pain noted for 2 days. Sweats continued on and off. Localized arm pain for 4 days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,UNK,,,,,,"['Back pain', 'Chills', 'Headache', 'Hyperhidrosis', 'Immediate post-injection reaction', 'Neck pain', 'Pain', 'Pain in extremity', 'Pyrexia']",UNK,JANSSEN, 1087548,CT,61.0,F,"I felt no immediate side effects of the shot, but 2 hours later, while sitting calmly, my heart rate suddenly elevated and I began to feel light headed. My home blood pressure monitoring kit provided a reading of 149/99 and a resting heart rate of 108. Normally, my blood pressure is very well maintained with my meds and hovers in the 118/75 range. My resting heart rate is usually below 70. I was going to dial 911 but within 5 minutes, my heart rate began to slow down and I felt better. When I rechecked my numbers at 8 pm, BP was down to 118/80 and resting heart rate was 70.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PHM,160 mg Diovan once/day 5 mg Amlodipine Bestylate once/day,none,"hypertension, rheumatoid arthritis, gluten intolerance sensitivity to epinephrine and stimulants causing tachycardia",,none known,"['Blood pressure increased', 'Dizziness', 'Heart rate increased']",1,JANSSEN,IM 1087552,NY,69.0,F,"About 9 hours after the injection, I experienced chills, increased heart rate, and headache. I began taking alternate doses of aspirin and acetaminophen. By 5 a.m., chills were gone.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/10/2021,1.0,PVT,Metrogel for rosacea,None,Rosacea,Shringrix,"Seasonal allergies to pollens, dust mites, cat dander","['Chills', 'Headache', 'Heart rate increased']",1,JANSSEN,SYR 1087565,VA,55.0,M,"General malaise within 1 hour of injection. Worsening to fever, chills, severe headache, and nausea within 6 hours of injection. No medication taken. Symptoms returned to general malaise 30 hours after injection.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,"Berkley & Jensen, Cetirizine Hydrochloride, 10mg, 03/08/2021, 8:00 AM",None,None,,Unverified childhood adverse response to penicillin,"['Chills', 'Headache', 'Malaise', 'Nausea', 'Pyrexia']",1,JANSSEN,SYR 1087567,IN,55.0,F,Fever up to 102 Severe headache for 24 hours Nausea Chills Severe joint pain - felt like I was in fire,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,Multi vitamin Supreme B vitamins Zyrtec,None,None,,Night shades,"['Arthralgia', 'Chills', 'Headache', 'Nausea', 'Pyrexia']",UNK,JANSSEN,SYR 1087570,TX,25.0,M,chills (woke up cold in middle of the night and couldn't stop shivering),Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/10/2021,1.0,PUB,,,,,,"['Chills', 'Feeling cold']",,JANSSEN,IM 1087580,TX,70.0,F,"High fever, headache, muscle pain, neck pain, dizziness, tremors starting with in 7 hours of injection lasting all night and next day",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,OTH,CARVEDILOL 25MG TAB TEV TWICE A DAY (morning & evening) (BP) LISINOPRIL/HCTZ 20-12.5MG TAB LEG DR K TWICE A DAY (morning & evening) (BP) GLIPIZIDE XL 5MG TAB GRE ONCE A DAY (morning) (BLOOD SUGAR) LEVOTHYROXIN 100MCG TAB,none,"High Blood pressure, heart bypass, diabetic,",,Penicillin,"['Dizziness', 'Headache', 'Myalgia', 'Neck pain', 'Pyrexia', 'Tremor']",1,JANSSEN,SYR 1087585,FL,,F,Caller is a M of unknown age reporting he has just called PC. He took the first dose of the Johnson and Johnson COVID-19 vaccine at 1000 on 3/5 and wants to know if he can take ibuprofen or acetaminophen for a headache. Advised caller would need to contact MD or pharmacist for advice.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/05/2021,,,UNK,,,,,,['Unevaluable event'],1,JANSSEN, 1087586,MD,78.0,F,":Took vaccine at 1:15pm March 9 then 12 hours later at 1:15 am March she started shivering and threw up once. Felt lousy. Headache No rashes, injection site clear. No fever Took Tylenol 9:30 am for headache",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/10/2021,1.0,PVT,None,,COPD,,Penicillin,"['Chills', 'Feeling abnormal', 'Headache', 'Vomiting']",UNK,JANSSEN, 1087587,TX,27.0,F,"Janssen COVID-19 Vaccine EUA Sore arm, woke up at 1:00am with chills but no fever. I went back to sleep. When I got up at 5:40am, I had a headache and my body was aching. I took ibuprofen. After a few hours, those symptoms are much milder.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/10/2021,1.0,PHM,"Vyvanse, Tylenol",None,None,,None,"['Chills', 'Headache', 'Pain', 'Pain in extremity']",UNK,JANSSEN, 1087591,IN,53.0,M,"Strong Headache for about 18 hours, and full body muscle ache for about 24-36 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,QVAR RediHaler (beclomethasone dipropionate HFA) and Omeprazole 20MG.,None,None,,None,"['Headache', 'Myalgia']",UNK,JANSSEN,SYR 1087595,VA,60.0,F,Patient experienced a seizure lasting 2-3 minutes approximately 1-2 minutes after receiving the vaccine. patient has a history of seizures/epilepsy.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/10/2021,03/10/2021,0.0,PHM,,,epilepsy,,,['Seizure'],1,JANSSEN, 1087596,NY,51.0,F,"I felt pain in my left arm where the vaccine was injected, but not limited to the site, but also under the arm and in the full arm till the arm wrest. Also, it included pain in the arm pit. I didn't go to a doctor. The pain was reduced after taking two 500 mg Tylenol, but there I still feel my left arm heavy and not normal.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/10/2021,1.0,OTH,Bisoprolol 2.5 mg Valsartan 160mg,,Hypertension,,,"['Axillary pain', 'Injection site pain', 'Pain in extremity']",UNK,JANSSEN, 1087599,IN,59.0,F,"Chills, headache, body aches and very tired for about 24 hours. Took Tylenol every 6 hours. Redness and raised area where shot was administered and is still that way.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,"Daily vitamin, vitamin d and vitamin c",No,No,,Amoxicillin,"['Chills', 'Fatigue', 'Headache', 'Injection site erythema', 'Injection site swelling', 'Pain']",1,JANSSEN,SYR 1087600,,52.0,M,I had a head-splitting headache and body aches. I would not take this vaccine again.,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/01/2021,03/10/2021,9.0,UNK,None,None,None,,None,"['Headache', 'Pain']",UNK,JANSSEN, 1087603,VA,34.0,F,"Extreme tiredness, fever over 103 for 2 days, migraine headache day of and 3 days afterwards. Extreme sweating and chills",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,UNK,Metformin,None,L.A.D.A.,,"Rye, black pepper","['Chills', 'Fatigue', 'Hyperhidrosis', 'Migraine', 'Pyrexia']",1,JANSSEN,SYR 1087606,WI,31.0,M,"Nausea, Ice Pick headaches behind eyes, fever , joint soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/10/2021,1.0,PVT,"Venlafaxine, Buspirone , vitamin D",none,none,,none,"['Arthralgia', 'Headache', 'Nausea', 'Pyrexia']",1,JANSSEN,IM 1087609,CT,41.0,F,"I woke up with an excruciating headache (with light sensitivity) that did not initially respond to Tylenol. Although I did not have a fever, I had temperature regulation issues all night - alternating between hot and cold - and woke up sweaty. Headache responded to Advil in the morning but I still have a minor lingering headache a few hours later.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/09/2021,03/10/2021,1.0,WRK,"Lisinopril, Loratadine, Camila",none,"hypertension, obesity",,none,"['Feeling of body temperature change', 'Headache', 'Hyperhidrosis', 'Photophobia']",1,JANSSEN,SYR 1087613,NJ,43.0,F,Fever Severe muscle pain whole body Headache Pain at injection site,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/10/2021,1.0,PUB,Probiotic florastar Multi vitamin Vitamin D 1000u,None,None,,Shellfish,"['Headache', 'Injection site pain', 'Myalgia', 'Pyrexia']",1,JANSSEN,IM 1087636,NC,79.0,M,"Left eye blurred vision - persistent, worse at the end of the day. Difficulty focusing. Also general overall fatigue.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/05/2021,02/08/2021,3.0,PUB,"Rosuvastatin, magnesium, duloxetine, bisoprolol, CoQ10, Chlorthalidone, Fishoil, telmisartan, latanoprost","No illness at time, but was getting antibiotic infusion, vancomycin and rocephin for discitis - last infusion on 2/22/21.","Hyperlipidemia, ED, Hypertension, CAD, OSA, Glaucoma, Osteoarthritis, impaired glucose",,NKDA,"['Fatigue', 'Ophthalmological examination', 'Vision blurred']",2,MODERNA,IM 1087637,OH,41.0,F,"Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection site, fever, chills, rash around injection site, down arm ans up shoulder and neck Day after and progression: muscle weakness to the point of falling down and inability to hold onto items, SOB, fatigue, blurred vision, ringing in ears, dizziness. Pain, numbness, tingling throughout body. Cough tasting blood, flank pain, intermittent urinary incontinence and increase urination at night, nightmares, anxiety, depression. Today: SOB, cough tasing blood, extreme fatigue, dizziness, tinnitus, nightmares, anxiety, depression. 03/02/21 New onset diagnosis: Severe Asthma I have not been able to work since 01/08/2021",Not Reported,,Not Reported,Not Reported,,Yes,N,01/08/2021,01/08/2021,0.0,UNK,No,No,Migraines,,No,"['Anxiety', 'Asthenia', 'Asthma', 'Chills', 'Depression', 'Dizziness', 'Dyspnoea', 'Fall', 'Fatigue', 'Flank pain', 'Grip strength decreased', 'Haemoptysis', 'Hypoaesthesia', 'Impaired work ability', 'Injection site pain', 'Injection site rash', 'Lacrimation increased', 'Muscular weakness', 'Nightmare', 'Pain', 'Paraesthesia', 'Pollakiuria', 'Pyrexia', 'Rhinorrhoea', 'Taste disorder', 'Tinnitus', 'Urinary incontinence', 'Vision blurred']",2,PFIZER\BIONTECH,SYR 1087639,AZ,56.0,F,"Muscle aches, nausea, fatigue",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/10/2021,1.0,PUB,Flonase,None known,Seasonal allergies,,None,"['Fatigue', 'Myalgia', 'Nausea']",1,JANSSEN,SYR 1087646,VA,19.0,F,"Janssen COVID-19 Vaccine EUA Symptoms started yesterday, March 9th, with muscle aches in my lower back a couple hours after receiving the shot. The muscle aches spread throughout my body as time went on, and joint pain and headaches came as the muscle aches worsened. I took two ibuprofens, though they had no effect. A bit later in the day, I developed a fever and felt very nauseous. When I went to sleep, I had a hard time staying asleep and ended up vomiting when I woke up at around 1:00AM. Today, March 10th, I continue to have muscle aches, joint pain, a headache, and slight nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,PUB,,,Asthma,,,"['Arthralgia', 'Back pain', 'Headache', 'Insomnia', 'Myalgia', 'Nausea', 'Pyrexia', 'Vomiting']",1,JANSSEN, 1087647,NJ,82.0,M,82-year-old male who presents after getting dizzy and weak just prior to arrival. Patient was receiving his first dose of COVID. Pt's blood pressure was checked and was found to be 78 systolic. On arrival patient's BP was 91. Patient states that when he gets up he can still dizzy however while in bed patient currently asymptomatic this time. According to the patient's failure member he has been dizzy and increasingly dizzy over the past few days.,Not Reported,,Not Reported,Yes,2.0,Not Reported,U,03/09/2021,03/09/2021,0.0,PVT,,,,,,"['Asthenia', 'Dizziness', 'Full blood count abnormal', 'Haemoglobin decreased', 'Neutrophil count decreased', 'Platelet count decreased', 'White blood cell count decreased']",1,PFIZER\BIONTECH,IM 1087654,NE,24.0,M,"Chills, fever, fatigue, increased heart rate started at 6 hours after vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/10/2021,1.0,SCH,None,None,None that are known,,azithromycin,"['Chills', 'Fatigue', 'Heart rate increased', 'Pyrexia']",1,JANSSEN,SYR 1087659,IN,51.0,F,"Chills started about 8:30pm. Shaking started about 9:00. Fell asleep and woke up at 11 with sweats and fever of 101.9, terrible headache and muscle aches. Took 2 Tylenol and 2 ibuprofen which brought the fever down but the body aches and headache lasted until well into the afternoon of the 9th of March.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,"Nasacort, multi vitamin b complex b12 D3 probiotic",None,None,,NKA,"['Chills', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Pyrexia', 'Tremor']",1,JANSSEN,SYR 1087664,IN,50.0,F,Started feeling dizzy the next morning.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/10/2021,1.0,PHM,Zoloft 125mg. Hydrocodone 7.5mg twice a day. Tizanidine 4mg 3 times a day as needed. Super B complex once a day. D3 50mcg once a day.,None,Chronic back and leg pain. Arthritis in both hips.,,Cymbalta makes me dizzy and extremely tired.,['Dizziness'],1,JANSSEN,SYR 1087671,NC,26.0,F,"Fever, aches, chills, sweats, racing pulse, swollen ears, vomiting. Fever and aches continuing to the next day. Unable to sleep due to pain and getting up several times at night to vomit.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,UNK,Metoprolol Tartrate 25mg Tablets Duloxetine DR 60mg Capsules Meloxicam 15mg Tablets Vienva 0.1mg/0.02mg Tabs 28s Hydroxychloroquine 200mg Tablets multivitamin,,Undiagnosed autoimmune disease POTS,,penicillins,"['Chills', 'Hyperhidrosis', 'Insomnia', 'Pain', 'Palpitations', 'Pyrexia', 'Swelling', 'Vomiting']",1,JANSSEN,IM 1087673,MN,69.0,F,"chills, headache, muscle aches, severe nausea, slight fever, very tired",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,Citalapram 10mg Probiotic 1 tablet,none,none,,none known,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea', 'Pyrexia']",1,JANSSEN,SYR 1087678,LA,36.0,F,"Fever (no temp taken), chills, nausea, headache, fatigue, no hunger. Symptoms onset Saturday 3/6/2021 at 10:30 PM subsided at 4:00 AM but fatigue and nausea were still present until Monday 3/8/2021. Monday evening 3/8/2021 symptom onset of fatigue and nausea were present again. Tuesday morning 3/9/2021 fatigue and nausea with possible faintness were ever present but subsided about 11:00 AM. Fatigue is still present today (Wednesday) 3/10/2021 with some nausea.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PVT,OZEMPIC 0.25 mg; EnbreL SureClick 50 mg/mL; folic acid 1 MG tablet; methotrexate 2.5 MG Tab; pregabalin 50 MG capsule; verapamiL 120 MG C24p; levothyroxine 50 MCG tablet; inulin 2.5 gram Chew; Lactobacillus rhamnosus GG 10 billion cell caps,,"Fibromyalgia; Migraine without aura and without status migrainosus, ; Hypothyroidism; Rheumatoid arthritis",,Gatifloxacin; Macadamia Nut Oil; Tuna Oil,"['Chills', 'Decreased appetite', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia']",1,JANSSEN,IM 1087679,FL,70.0,M,"fever Advised caller injection site pain, fatigue, headache, muscle aches, chills, joint pain, and fever can occur following COVID-19 vaccination. Swollen lymph nodes and nausea have also been reported, but not as common. Please seek medical attention if experiencing any shortness of breath, throat swelling, weakness, or diffuse body rash.",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/07/2021,03/07/2021,0.0,UNK,cetirizine hcl 10mg,,,,Hay Fever,"['Arthralgia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Lymphadenopathy', 'Myalgia', 'Nausea', 'Pyrexia']",1,JANSSEN,IM 1087680,TX,64.0,F,She experienced headache and fatigue for a couple of days. She took acetaminophen and rested to recover and it helped.,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/06/2021,03/06/2021,0.0,PHM,,,,,,"['Fatigue', 'Headache']",1,JANSSEN,IM 1087694,IN,50.0,F,"Fever of 99-100, plus chills and slight headache that started at about 8pm on 03/08/21. Fever broke around 9am on 03/09/21. I took Tylenol twice, once in the evening and once in the morning. Developed a fever (99.1F) and slight headache again at 7pm 03/09/21. This was not as severe and was lessening by 11:30pm (98.6F). My normal temperature is about 97.6F. I took Excedrin migraine at the onset of the fever and headache.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,None,None,None,Pre-exposure Rabies vaccine About 25 yrs old Fever and fatigue in last dose of a series of three doses.,Morphine Baby oil,"['Chills', 'Headache', 'Pyrexia']",,JANSSEN, 1087700,IN,54.0,M,"Chills, uncontrolled shaking, headache, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,UNK,,,,,,"['Chills', 'Headache', 'Pain', 'Tremor']",1,JANSSEN,IM 1087708,IN,70.0,F,Extreme chilling and body aches. Aching lasted about 24 hours.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,Multiple Vitamin Calcium with Vitamin D Fish Oil,None,None,,Morphine Tramadol,"['Feeling cold', 'Pain']",1,JANSSEN,IM 1087711,TX,72.0,F,"Arm soreness (injection arm), low grade fever",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,,,,,,"['Limb discomfort', 'Pyrexia']",UNK,JANSSEN, 1087720,,50.0,F,Fever Chills Headache Nauseated Dizzy Light Headed Tired,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/07/2021,03/08/2021,1.0,UNK,,,,,,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pyrexia']",UNK,JANSSEN, 1087721,LA,68.0,M,"Fever, Aches, Fatigue for a 48 hour period beginning 12 hours after the injection. Highest fever was 102 deg",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PVT,"Xarelto 20 mg 1 x a day, Metoprolol tartrate 25 mg 2 x a day",None,A-Fib,,None,"['Fatigue', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1087728,,51.0,F,"Headache, chills, body aches and low fever for 2 days",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/09/2021,1.0,UNK,None,None,None,,Penicillin,"['Chills', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1087729,IN,49.0,M,Fever 101.4 for about 24hrs with headache and fatigue,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,,,,,,"['Fatigue', 'Headache', 'Pyrexia']",1,JANSSEN, 1087730,VA,57.0,M,"12 hours post injection developed severe chills, HA, muscle pain and fever of 101.1 along with moderate injection site tenderness with slight itchy rash on arm. Took 500mg Tylenol and went to bed. Felt better in morning fever down to 98.8 with additional Tylenol taken at 0500 am before arising. Moderate fatigue.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PUB,Lipitor 10mg q d,None,High cholesterol.,,None known,"['Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site pruritus', 'Injection site rash', 'Myalgia', 'Pyrexia']",1,JANSSEN,IM 1087735,NH,68.0,M,"On 3/5/21 at approximately 0200 became congested suddenly. Doctor was notified with N.O. Torsemide 20 mg tab via PEG-tube NOW, IM Rocephin 1 mg QD x7 days for possible aspiration, Chest X Ray, CBC/BMP in morning, and may suction resident if tolerated PRN. Received both Torsemide and the Rocephin and then deceased at 0350.",Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,02/18/2021,03/05/2021,15.0,SEN,"Medications received day of dose 2 (2/18/21)vaccination: abilify 20mg, benztropine mesylate 2mg, celexa 40mg, clonazepam 2mg, Aricept 10mg, lactulose 30ml, synthroid 75mcg, Pepcid 20mg, Risperdal 1mg in am and 2mg at HS, senna-s 2 tablets,","12/7/20 BMP with elevated kidney function, some diuretics on hold 12/10/20 BMP with continued elevated kidney function, diuretic decreased 12/14/20 C/O body aches, rapid covid test negative, potassium adjusted based on labs 12/15/21 BMP drawn, increased weight gain. N.O. increase torsemide to 100mg PO QD, QD weights, and weekly BMP Q Monday. 12/28/20 Vomited small amount, rapid covid negative, continued with weight gain and diuretics increased. 1/7/21 Difficulties swallowing, picked up by ST and fluids change to nectar thick consistency. 1/11/21 Drowsy and weak with low CBGs. Dieuretic put on hold 1/12/21 Low temperature and low CBG 1/13/21 All diuretics put on hold. N.O. nephrology consult for advancing CKD & explore if dialysis is an appropriate options. Diet downgraded to all ground. 1/15/21 Had modified barium swallow and per report recommends NPO r/t aspiration. Diet changed to puree, thin liquids. 1/18/21 UA sent for C&S if indicated for / blood clots in urine. Then had congested cough. Had CXR and results showed bilateral lower lobe infiltrates and bilateral effusions. 1/19/21 Sent to ER for eval of lethargy, not eating, and acute on chronic kidney injury. Admitted to CMC. 1/31/21 Returned form hospital NPO with PEG tube, all diuretics D/C. 2/1/21 Oral thrush tx 10 cc Nystatin swish and spit TID for 10 days 2/8/21 CBC/BMP with no significant acute findings 3/4/21 Increased weight and started back on diuretic torsemide 20mg. Approximately 0200 on 3/5/21 became congested. Doctor was notified with N.O. Torsemide 20 mg tab via PEG-tube NOW, IM Rocephin 1 mg QD x7 days for possible aspiration, Chest X Ray, CBC/BMP in morning, and may suction resident if tolerated PRN. 3/5/2021-0350 deceased.","Pneumonitis due to inhalation of food and vomit, acute kidney failure, anemia, dysphagia, malaise, weakness, cognitive communication deficient, abnormal posture, personal history of COVID19, gastrostomy statsu, vitamin D deficiency, essential tremor, chronic diastolic heart failure, muscle spasm, benign prostatic hyperplasia without lower urinary tract symptoms, gout, sleep apnea. Anxiety disoreder, atrial fibrillation, dementia with behavioral disturbance, lymphedema, epiliepsy, schizophrenia, major depressive disorder, hyperlipidemia, hypothyroidism, Essential hypertenision, drug induced subacute dyskinesia",,"Codeine, Buspar, Clozaril, Geodon, Mellaril, Seroquel, Thorazine, Pineapple, Plum, Prune, Dust, Tetanus Toxin","['Death', 'Respiratory tract congestion', 'Weight increased']",2,PFIZER\BIONTECH,IM 1087744,IL,90.0,M,"Received Moderna Vaccine 1st dose on 2/24/2021. Went for a cystoscopy and biopsy on 3/8/2021. On 3/9/2021 was sent to the ER and admitted for acute renal failure, UTI, and dehydration.",Not Reported,,Not Reported,Yes,,Not Reported,,02/24/2021,03/09/2021,13.0,SEN,,,,,,"['Acute kidney injury', 'Biopsy', 'Cystoscopy abnormal', 'Dehydration', 'Urinary tract infection']",1,MODERNA,IM 1087752,IL,69.0,F,"pt states that afternoon after she got the covid vax that she developed fever, body aches, chills, loss of appetite, headache. Feels just like she did when she had the Covid Virus. Her urine is dark yellow and she is sweating profusely. Pt still has all of these symptoms and has a phone visit w/ her PCP today 3/10/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,PUB,"levothyroxine .75mg , metoprolol 0.5 mg,",no,thyroid disease,,"penicillin, mice, mold, cockroaches, raw sugar,","['Chills', 'Decreased appetite', 'Headache', 'Hyperhidrosis', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1087754,IN,55.0,M,Headache. Cough. Lump in throat,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/10/2021,2.0,UNK,Blood pressure meds cholesterol meds Prozac ALLOPURINOL 300 MG TABLET AMLODIPINE BESYLATE 5 MG NIACIN ER 500 MG TABLET TABLE CHLORTHALIDONE 25 MG TABLET FLUOXETINE HCL 20 MG CAPSULE Citrus Bergamot Red yeast rice,None,High blood pressure,Shingles vaccine,No,"['Cough', 'Headache', 'Sensation of foreign body']",1,JANSSEN,SYR 1087756,CO,31.0,M,"Woke up March 9th and had trouble breathing. Fell well short of getting full breaths, chest hurt. Took aspirin and slept for 6 hours. Felt about the same through the evening. Next day, still having trouble getting full breaths but less pain.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/09/2021,3.0,UNK,,,,,,"['Chest pain', 'Dyspnoea', 'Somnolence']",1,JANSSEN,SYR 1087761,IN,75.0,F,"Got shot at 1:30pm. At 7:30 pm got very tired. Went to be at 8pm. Chills, headaches body aches, very tired",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,,,,,Penicillin,"['Chills', 'Fatigue', 'Headache', 'Pain']",1,JANSSEN,IM 1087763,IA,62.0,F,Difficulty breathing leading to organ failure and death,Yes,03/10/2021,Not Reported,Yes,2.0,Not Reported,N,03/05/2021,03/08/2021,3.0,PVT,,,Diabetes,,,"['Death', 'Dyspnoea', 'Laboratory test', 'Organ failure']",UNK,MODERNA, 1087764,MI,67.0,M,"Two hours after receiving the vaccine on 3/4/21, he started feeling very tired and had a 100.2 temp. By evening he was feeling very cold and not eating much. On 3/5/21 he was sleeping alot, had headache, chills and fever, no appetite, diaphoretic. At 8pm he could not get up out of his chair and was disoriented. Wife call an ambulance. He was admitted for altered mental status. Blood cultures showed streptococcus pneumoniae. He was hypoxic at 89%. BP 171/96, pulse 85, temp 37.3C. Chest xray showed bilteral infiltrates and a masslike density in the right lung apex. Encephalopathy, pneumonia and sepsis diagnosed. Ct of head normal.WBC count 19 and amonia 24. Wife told me he had a spinal tap on 3/9/21 and that it showed bacterial meningitis. I do not have the lab reports on that yet. THe infection control doctor told wife he is critical.",Not Reported,,Yes,Yes,,Not Reported,N,03/04/2021,03/04/2021,0.0,PUB,baby ASA; atorvastatin 20mg; eliquis;diltiazem ER daily; lasix; jardiance;lisinopril; metroprolol-HCTZ; novolog insulin; tresiba,none,diabetes mellitus type 2 on insulin; hypercholesterolemia; hypertension; AFib with a pacemaker,,penicillins,"['Ammonia', 'Blood magnesium normal', 'Blood potassium decreased', 'Body temperature increased', 'Chest X-ray abnormal', 'Chills', 'Computerised tomogram head normal', 'Computerised tomogram thorax abnormal', 'Decreased appetite', 'Disorientation', 'Dysstasia', 'Encephalopathy', 'Fatigue', 'Feeling cold', 'Gram stain positive', 'Headache', 'Hyperhidrosis', 'Hypersomnia', 'Hypoxia', 'Lumbar puncture abnormal', 'Lung infiltration', 'Lung opacity', 'Meningitis bacterial', 'Mental status changes', 'Pneumonia', 'Pulmonary mass', 'Pyrexia', 'Sepsis', 'Streptococcus test positive', 'White blood cell count increased']",2,MODERNA,IM 1087768,OH,64.0,F,"Janssen COVID-19 Vaccine EUA Injection site bruising, swelling, redness, burning General - headache, very very tired, bloating/puffiness, muscle aches, nausea, low grade fever, light dizziness Took ibuprofen and drank lots of water... cold compress on arm...rest when needed As of Wednesday morning, the reactions are lowering and slowing down. The site is still swollen some and bruised and red.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PHM,"Duloxetine, D3, Sambucal, Loratadine, Senna S, Turmeric Curcumin, Probiotic",None,"Fibromyalgia, Osteoarthritis, Rotoscoleosis, Spondylolisthesis, Osteoporosis",,None,"['Abdominal distension', 'Dizziness', 'Fatigue', 'Headache', 'Injection site bruising', 'Injection site erythema', 'Injection site pain', 'Injection site swelling', 'Myalgia', 'Nausea', 'Pyrexia']",UNK,JANSSEN,IM 1087771,WI,51.0,F,"After the vaccination, I felt a little dizzy waiting in the parking lot and had a sore arm, but felt fine otherwise. (12:00-1:00 pm) After returning home, I felt increasingly tired and warm. I laid down and took my temperature after walking the dog around 3:00 pm. My temperature read 99 degrees. I drank a lot of pedialyte to hydrate. Throughout the afternoon, I felt sluggish and the glands seemed to swell up on the side of my neck. I also got a headache. My temperature dropped down to 98.7 before I went to bed, but this morning, my glands under my jawline are a bit more swollen and I still have a slight temperature; 98.9 degrees. My eyelids are puffy and I feel a little feverish, but it is tolerable.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,PVT,"Multi--Vitamin, Omeprazole 20 mg 1 x/ day, Fluoxetine 10 mg 1x/per day.",Minor sinus issues,"IBS, possible blood clotting disorder -discovered during hysterectomy-blood failed to clot after 10 minutes of testing, was bleeding for three days in hospital.) Asthma",,"Morphine, Cardec DM gold (reaction) Chlorine, Lactose, some metals, dust","['Dizziness', 'Fatigue', 'Headache', 'Lymphadenopathy', 'Pain in extremity', 'Periorbital swelling', 'Pyrexia', 'Sluggishness']",1,JANSSEN,SYR 1087774,VA,69.0,M,"Muscle Aches, Body aches, Lethargy, Headache, Lasted 24hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,Various Vitamins,No,No,,Poison Ivy Shellfish,"['Headache', 'Lethargy', 'Myalgia', 'Pain']",1,JANSSEN,SYR 1087791,SC,55.0,F,"Fever, chills, nausea, headache",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,Lisinopril 20 mg,none,none,,"sulfa, Microzide, some penecillin related drugs but not Keflex","['Chills', 'Headache', 'Nausea', 'Pyrexia']",UNK,JANSSEN, 1087792,TX,30.0,F,"Night sweats, headache, fatigue. Fast and elevated heart rate beginning on 3/9/2021 and continuing on 3/10/2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/08/2021,03/09/2021,1.0,OTH,Birth control pills,None,None,,None,"['Fatigue', 'Headache', 'Heart rate increased', 'Night sweats']",1,JANSSEN,SYR 1087797,NJ,31.0,F,"i have experienced head ache, fatigue, fever of 101.2, body ache for 24 hours now , i have been taking Tylenol for the past 24 hours but i cant brake the fever",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,PVT,chlorthalidone 25 mg,,,,,"['Fatigue', 'Headache', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1087798,IN,50.0,M,"Fatigue, body ache, chills, headache. Chills starting Monday night/Tue morning while trying to sleep. Restless through night, then very tired Tue. Took Tue off from work and spent at home. All largely better by Tues evening. Wed morning, left arm still tender at injection site, but nothing serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,"Fluoxetine 10mg, loratadine 10mg, melatonin 5mg",none,none,,none,"['Chills', 'Fatigue', 'Headache', 'Impaired work ability', 'Injection site pain', 'Pain', 'Restlessness']",1,JANSSEN,IM 1087802,ME,61.0,F,"HEADACHE, CHILLS,BODY ACHES, NAUSEA, FATIGUE",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/08/2021,03/09/2021,1.0,PHM,,NONE,,,,"['Chills', 'Fatigue', 'Headache', 'Nausea', 'Pain']",1,JANSSEN,IM 1087806,OK,48.0,M,"Within 30 minutes post vaccine administration, patient started having seizure like symptoms (Altered mental status, clenched jaw, non-verbal, right sided headache) - V/S WNL, Ambulance called and patient was taken to ED for evaluation. Responsive during transport to ED. Patient reported back to baseline after 1.5 hours.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,OTH,"Keppra, Xarelto, Atorvastatin",None stated,"Seizures, history of stroke",,Penicillan,"['Aphasia', 'Computerised tomogram', 'Full blood count', 'Headache', 'Joint stiffness', 'Mental status changes', 'Metabolic function test', 'Seizure like phenomena']",1,JANSSEN,IM 1087807,FL,49.0,F,"received the vaccination at 0900 and has since developed bluing of the fingertips, chills, fever of 101 and tingling of the fingers. She has taken 2 Tylenol for her fever. Advised would recommend eval to HCF for symptoms. They will go to Medical Center. Followed up with caller who adv that they went to the ED. She was evaluated and discharged home.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/08/2021,03/08/2021,0.0,UNK,,,,,,"['Chills', 'Cyanosis', 'Paraesthesia', 'Pyrexia']",1,JANSSEN,IM 1087811,IN,54.0,F,"I woke up the day after my vaccine feeling slightly nauseous and with chills, which I expected. However, by 8:00 am I had a headache equal to the worst migraine I've ever had. I laid in bed all day trying not to move as any movement caused intense nausea. At times, I felt that my heart was fluttering or irregular. I vomited 3 times, but despite having eaten dinner the night before, I seemed to have nothing to throw up. I vomited clear liquid, if anything at all, which had a strong metallic taste. The vomiting was very intense, leaving me sweating and exhausted. I fell asleep around 8:00 pm, and when my husband woke me at 9:15 to check on me, I could tell that the sharpness and intensity of the headache was gone. I still had a headache, but it was a normal headache. Today, the 10th, I woke up feeling mostly normal, just weak.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/09/2021,1.0,OTH,None,None,None,,Sulfa,"['Asthenia', 'Cardiac flutter', 'Chills', 'Fatigue', 'Headache', 'Heart rate irregular', 'Hyperhidrosis', 'Nausea', 'Vomiting']",UNK,JANSSEN,IM 1087814,FL,24.0,F,"Symptoms started around hour 2 with nausea, injection sight was not sore but had some discomfort below injection site. Continued to have nausea. Had chills in the middle of the night, chills started around 1-2 am and was gone by morning. Woke up with body aches and very tired/fatigued. By hour 18 had diarrhea. Still having fatigue and body aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,PUB,none,none,none,,none,"['Chills', 'Diarrhoea', 'Fatigue', 'Injection site discomfort', 'Nausea', 'Pain']",1,JANSSEN,IM 1087818,CT,56.0,M,"Fever, nausea, pain under left arm in armpit, diarrhea, headaches, aches.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,PVT,blood pressure med,na,na,,na,"['Axillary pain', 'Diarrhoea', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN, 1087825,MN,66.0,F,"6:30 p.m. chills, body aches, fever 99.9 8:30 p.m. nausea, fever 101.4 10:00 p.m. fever 101.9 1:00 a.m. headache 2:15 a.m. headache fever 99.7 - took 2 Advil",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,"Atenolol, Levothyroxin, Omeprazole, Finasteride, Atorvastatin Vitamin D, Calcium, Low Dose Aspirin, Elderberry, Omega-3",None,Type 2 Diabetes,,"Penicillin, Caffeine, Codeine","['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",UNK,JANSSEN,IM 1087826,FL,52.0,F,"Chills, fever, heart racing, swollen axial lymph nodes, headache and teeth pain. Symptoms are resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/07/2021,0.0,PUB,,,,,,"['Chills', 'Headache', 'Lymphadenopathy', 'Palpitations', 'Pyrexia', 'Toothache']",1,JANSSEN,IM 1087828,AL,69.0,M,"Chills, headache behind eyes, fever, muscle pain/aches; now only bad headache and body aches; time now is 10:05;",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,PHM,Cholesterol medicine; vitamin D,None,None,,Penicillin,"['Chills', 'Headache', 'Myalgia', 'Pain', 'Pyrexia']",UNK,JANSSEN,SYR 1087830,IN,50.0,F,"Immediate burning sensation traveled from left side of body: arm, shoulder, neck, back, left ear, and chest. Then traveled across entire face eyebrows, cheeks, and lips felt numb and irritated.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PVT,"Metformin (500 mg), Victoza (18 mg/3 ml Pen), Atorvastatin (20mg), and",,Diabetes and high cholesterol,,"Food: wheat, yeast, chocolate, green beans, oranges, tree nuts","['Burning sensation', 'Hypoaesthesia oral']",UNK,JANSSEN, 1087832,FL,37.0,M,"Severe headache for 24 hours, lethargy, body soreness",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/09/2021,1.0,PHM,None,None,None,,None,"['Headache', 'Lethargy', 'Pain']",UNK,JANSSEN,IM 1087842,NY,32.0,F,"nausea, light headedness, chills, fatigue, fever, headache, body aches advil for headache symptoms lasted ~12 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,UNK,"levothyroxine, escitalopram",,"graves disease, asthma",,acetiminophen,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",UNK,JANSSEN, 1087845,CT,65.0,F,"nausea, aches, headache, very tired and weak",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/08/2021,2.0,PVT,blood pressure med,na,na,flu like symptoms after receiving flu shots over the years,erythromycin,"['Asthenia', 'Fatigue', 'Headache', 'Nausea', 'Pain']",1,JANSSEN, 1087847,TX,53.0,M,"The patient started having severe chills, and muscle aches on the back and neck at 10:00 PM . Then he took Tylenol for the pain at around 12:00 AM and then started sweating profusely.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,WRK,,,,,,"['Back pain', 'Chills', 'Hyperhidrosis', 'Musculoskeletal discomfort', 'Myalgia']",1,JANSSEN,SYR 1087854,TN,51.0,F,I tried to get up at 11:50pm and fell. My left side felt partially paralyzed. I was up a couple of hours and was trying to move my leg. I fell asleep and woke in the am and was able to walk,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/09/2021,0.0,PHM,"Gilenya, niphediphine, ampyra, modafinil I took thecovid shot",Multiple schlorosis,None,,None,"['Fall', 'Hemiparesis']",UNK,JANSSEN, 1087864,CA,,M,"Kidney failure; Three episodes of fall/hit head on each episode; Bloody urine; Dizziness; A spontaneous report was received from a consumer concerning a 88years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patients current condition included hypertension. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:062G20A) intramuscularly in the anatomical location for prophylaxis of COVID-19 infection. On 25 Feb 2021, patient was taken to ER where he was diagnosed with kidney failure and physician advised not to take second dose of Moderna vaccine. Laboratory details not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,02/25/2021,26.0,UNK,,Hypertension,,,,"['Blood urine', 'Dizziness', 'Fall', 'Renal failure']",UNK,MODERNA,OT 1087866,,51.0,M,"Chills, fever, body aches, headache, sore arm at injection site. Lasted two days.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,OTH,Senior multivitamin,,,"similar reaction to flu vaccines and shingles vaccine,",penicillin,"['Chills', 'Headache', 'Injection site pain', 'Pain', 'Pyrexia']",UNK,JANSSEN, 1087869,CO,46.0,M,"fever, violent chills, body aches, nausea",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PHM,Stelara,,"psoriasis, psoriatic arthritis",,Bactrim,"['Chills', 'Nausea', 'Pain', 'Pyrexia']",UNK,JANSSEN, 1087875,MD,21.0,F,"Headache, nausea, dizziness, chills, fever, runny nose, watery eyes",Not Reported,,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/09/2021,1.0,PHM,,,,,,"['Chills', 'Dizziness', 'Headache', 'Lacrimation increased', 'Nausea', 'Pyrexia', 'Rhinorrhoea']",UNK,JANSSEN, 1087876,IN,57.0,F,Very tired for three days. Difficulty thinking for three days. Fever and chills the next day.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,,,Diabetes type 2 High blood pressure,,Sulfa allergy,"['Chills', 'Fatigue', 'Mental impairment', 'Pyrexia']",1,JANSSEN,SYR 1087885,NY,68.0,M,Patient was found deceased in garage one day post vaccination,Yes,03/09/2021,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,PVT,"Asprin 325mg daily, Viagra 50mg- 1 daily as needed, Levothyroxine 225mcg daily, Metformin 500 mg daily, Lisinopril 40mg daily, Metoprolol 50mg extended release daily, Simvastatin 20mg daily",2/25: Saw provider for Adrenal Nodule,"Obesity, Hypothyroidism, Pre-diabetes, hypertension, and aortic aneurysm 4.5cm",,No known allergies,['Death'],1,PFIZER\BIONTECH,IM 1087892,FL,73.0,M,"3 am heart racing, exhaustion",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/10/2021,2.0,PUB,"Trelegy, Spiriva, Atorvastatin, Calcium, D, men's multiple, Zinc",COPD,"Compromised lungs, lung cancer in 2012. Upper lobe on left side removed, right side collapse in 1973- military vet. Right lung less than 50% function. Chronic COPD.",,Mushrooms,"['Fatigue', 'Palpitations']",1,MODERNA,SYR 1087895,IN,46.0,F,"At 3:00 pm the day after I received the Johnson&Johnson COVID-19 vaccine I developed a red, raised, swollen, hot, painful circle 5'' in diameter on my left arm under the injection site. My arm is hot to touch, swollen, and still painful the next day and the circle has spread more and has started to turn purple.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,OTH,,,asthma,,tree nuts,"['Injection site erythema', 'Injection site pain', 'Injection site rash', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity', 'Peripheral swelling', 'Skin discolouration']",1,JANSSEN,SYR 1087899,OH,60.0,F,"Severe headache, very tired, muscle aches,fever, short periods of dizziness, several hours of the feeling of pressure on my chest which then was replaced by significant burning sensation, bottoms of both feet were very painful and a wrist that i broke a couple of years ago and a knee which has caused pain in the past were very, very painful.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PUB,"Ginger, calcium, cinnamon, vitamin C, zincn",None,UTI,Flu,,"['Arthralgia', 'Burning sensation', 'Chest discomfort', 'Dizziness', 'Fatigue', 'Headache', 'Myalgia', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,SYR 1087908,IA,51.0,M,"Sore arm. About 3 hours after getting the shot, I started getting aches, feeling cold, and tired. The next morning my joints ached and I had a sore throat. I took a couple of Ibuprofen (200 mg each) and about an hour later, my aches started going away. By 8 pm the next day, I didn't have many side effects.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,PUB,"Tamoxifen, Venlaxafine, Xyzal, Krill Oil, Men's Multi-day Vitamin",None,Breast Cancer Survivor,,Sulfites,"['Arthralgia', 'Fatigue', 'Feeling cold', 'Oropharyngeal pain', 'Pain', 'Pain in extremity']",1,JANSSEN,SYR 1087914,IN,,F,"Patient was admitted for pancreatitis with history of cholecystectomy, no alcohol consumption, and unclear etiology. There is a concern of unknown effects of COVID vaccines. Patient received COVID Johnson and Johnson vaccine on 3/5 before developing nausea, vomiting, and diarrhea before being admitted for pancreatitis.",Not Reported,,Not Reported,Yes,,Not Reported,,03/05/2021,03/09/2021,4.0,UNK,,,,,,"['Diarrhoea', 'Nausea', 'Pancreatitis', 'Vomiting']",UNK,JANSSEN, 1087917,FL,24.0,M,Caller is pt's mother; not sure if fever and diarrhea are r/t vaccine or hx of Crohn's disease as he had a low grade temp of 99 at home yesterday prior to receiving vaccine.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/07/2021,03/08/2021,1.0,PHM,remicade IV q 7weeks,,hx of Crohn's disease,,,"['Diarrhoea', 'Pyrexia']",1,JANSSEN,IM 1087920,IN,59.0,F,"Muscle aches, feverish, stomach upset, sinus/cough",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/09/2021,1.0,PHM,,,COPD,,Sulpha IV Contrast Dye,"['Abdominal discomfort', 'Cough', 'Myalgia', 'Pyrexia', 'Sinus disorder']",1,JANSSEN,IM 1087922,FL,33.0,F,"chills, low grade fever, nausea, headache, body aches",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/09/2021,1.0,PHM,asprin 81mg,,PAI 4g/5g and MTHFR,,,"['Chills', 'Headache', 'Nausea', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1087935,IN,53.0,F,"Nausea, fatigue, muscle aches, chills, headache - started about 8 hours after injection and lasted about 12 hours",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/07/2021,03/08/2021,1.0,PUB,"Amlodipine 5mg, Lisinopril 10 mg, multivitamin",,,,,"['Chills', 'Fatigue', 'Headache', 'Myalgia', 'Nausea']",UNK,JANSSEN,SYR 1087949,NH,90.0,F,"3/6/2021 Expired at facility receiving Hospice Services since 8/1/2020. Hx Covid-19 June 2020. Prior to death: Resident began refusing meals and failing overall. On, 2/18 began with jaundiced skin, no other symptoms. ADPOA, Hospice APRN and MD updated. Comfort measures maintained as resident continued to have slow decline.",Yes,03/06/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,03/06/2021,37.0,SEN,dilTIAZem HCl ER Capsule Extended Release 24 Hour 120 MG Give 1 capsule by mouth in the morning; Lumigan Solution 0.01 % (Bimatoprost) Instill 1 drop in both eyes in the evening; MiraLax Powder 17 GM/SCOOP (Polyethylene Glycol 3350) Give 17,No new medical concerns or acute illness. Resident receiving Hospice Services from 8/1/20 with goal of care and comfort. Receiving compassionate visits from family.,"G30.9 ALZHEIMER'S DISEASE, UNSPECIFIED J44.9 CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED I48.91 UNSPECIFIED ATRIAL FIBRILLATION R13.10 DYSPHAGIA, UNSPECIFIED N18.30 CHRONIC KIDNEY DISEASE, STAGE 3 UNSPECIFIED D64.9 ANEMIA, UNSPECIFIED F33.9 MAJOR DEPRESSIVE DISORDER, RECURRENT, UNSPECIFIED M81.0 AGE-RELATED OSTEOPOROSIS W/O CURRENT PATHOLOGICAL FRACTURE G62.9 POLYNEUROPATHY, UNSPECIFIED Z86.16 PERSONAL HISTORY OF COVID-19 Z87.81 PERSONAL HISTORY OF (HEALED) TRAUMATIC FRACTURE Z86.73 PRSNL HX OF TIA (TIA), AND CEREB INFRC W/O RESID DEFICITS M10.9 GOUT, UNSPECIFIED H26.9 UNSPECIFIED CATARACT J30.9 ALLERGIC RHINITIS, UNSPECIFIED L21.9 SEBORRHEIC DERMATITIS, UNSPECIFIED L30.4 ERYTHEMA INTERTRIGO H40 GLAUCOMA K80 CHOLELITHIASIS H35.30 UNSPECIFIED MACULAR DEGENERATION L23.1 ALLERGIC CONTACT DERMATITIS DUE TO ADHESIVES K57.12 DVTRCLI OF SM INT W/O PERFORATION OR ABSCESS W/O BLEEDING D51.9 VITAMIN B12 DEFICIENCY ANEMIA, UNSPECIFIED R47.01 APHASIA",,None,"['Death', 'Diet refusal', 'General physical health deterioration', 'Jaundice']",2,PFIZER\BIONTECH,IM 1087952,MN,89.0,F,Resident fell out of her chair and was transferred to the ER with a diagnosis of a Mio cardial infarction and passed away in the ER.,Yes,12/27/2020,Not Reported,Not Reported,,Not Reported,N,12/27/2020,12/27/2020,0.0,SEN,"Lisinopril, donepezil, Memantine, Sertaline","Hypertention, COPD, Atrial Fibrilation",,,"Sulfa, Risperdal","['Death', 'Fall', 'Myocardial infarction']",1,PFIZER\BIONTECH,IM 1087957,NC,32.0,F,Developed a fever around 100-101 and headache around 10:30pm (approx 13 hours after vaccination). Fever has persisted until the following day (3/10 as of 11:30am) and headache has worsened. I also have other mild flu like symptoms like some sinus drainage but they have remained mild,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,PUB,None,None,None,,"Allergic to raw fruits, vegetables & tree nuts (oral allergy symdrome)","['Headache', 'Influenza like illness', 'Pyrexia', 'Sinus operation']",1,JANSSEN,IM 1087959,IN,58.0,F,24 hours of receipt my eyes hurt. My bones and joints hurt. I was extremely cold. Lasted approximately 4 hours 50 hours after receipt my eyes hurt again. I was freezing and shaking. My bones hurt again.I would start sweating and become extremely hot then cold again. My mouth was dry and I was extremely thirsty. I could not sleep. This lasted approximately 6 hours and I was fine. All reactions were very similar to those experienced when I had COVID in December 2020.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,Levothyroxine Lisinopril HCT Fluticasone Azelastine Breo Ellipta Spiriva Dicyclomine Pantoprazole Metformin Montelukast Sod Potassium Chloride ER Xolair ProAir RespiClick B-12 B-Complex Biotin Black CoHosh Calcium + D Cetirizine Cranberry,,Diabetes Asthma,,Pennicillan Duricef Tomatoes Cucumbers,"['Arthralgia', 'Bone pain', 'Dry mouth', 'Eye pain', 'Feeling cold', 'Hyperhidrosis', 'Thirst', 'Tremor']",1,JANSSEN,IM 1087960,AR,48.0,F,"She got home and did not have any reactions until last night around 10:00 PM when she got a bad headache, fever last night that was 100.1. Her back is killing her, her legs hurt and her left arm hurts as well. Her eyes are also watering. She has not taken anything for the symptoms. She tired to go to work, her husband said that she did not look good. She was sent home from work, she went to the nurses station at work, had a fever of 100.2 who told her to go home, it was a reaction from the vaccine, and to call us.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,OTH,None.,None.,None.,,None.,"['Back pain', 'Headache', 'Lacrimation increased', 'Pain in extremity', 'Pyrexia']",1,JANSSEN,IM 1087965,WI,48.0,F,On Thurs I start exp headache. Then on Saturday I developed a rash on my right side of forehead. I exp irritation to my eye was referred to Ophthalmologist. I went to the Urgent Care was diagnosed with Shingles.,Not Reported,,Not Reported,Yes,,Not Reported,Y,01/06/2021,01/07/2021,1.0,PVT,"Fluoxetine 40 mg, Vit D",No,"Depresion, Migraine",,Sulfa,"['Eye irritation', 'Headache', 'Herpes zoster', 'Rash']",1,MODERNA,IM 1087967,MD,45.0,M,Allergic skin reaction/break out at the site of the injection on outside of the arm and continuing under the arm down the arm. Bumpy itchy and redness.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,UNK,Olmesartan 40mg,Had scope of surgery on shoulder.,High blood pressure,,None,"['Injection site hypersensitivity', 'Injection site pruritus', 'Injection site reaction', 'Injection site swelling']",1,JANSSEN,SYR 1087968,MA,38.0,F,"Patient received J&J vaccine at clinic (lot # 1805022). at approximately 1530, patient has a history of anaphylaxis and was being observed for 30 minutes. Approximately 25 minutes into the observation period the patient was noted to be lethargic, weak, was able to answer questions stated that she felt tingling in throat, numbness, tingling in extremities, back pain. Progressed to feeling itchiness and continued lethargy, was not able to answer what day it was. At that point we assissted patient in wheelchair to get on stretcher behind curtain. Patient given diphenhydramine 50 mg x 1 at 1600, patient became more lethargic and given epinephrine 0.5 mg x 1 at 1603. Vitals after epi were sbp 138, HR ?? reported as elevated, and 02 sats 98. 911 was called. Patient was also nauseous once in wheelchair and on stretcher, wretching when transferred to stretcher patients lower extremities began shaking, lasting a few seconds. Patient motioning towards throat as is if having trouble breathing. Patient remained stable until EMS arrived. I t was reported to me that patient had been cleared by her MD to receive vaccine but to be monitored for 30 minutes.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,03/06/2021,03/06/2021,0.0,OTH,,,,,"lexiscan, xolair","['Asthenia', 'Back pain', 'Confusional state', 'Dyspnoea', 'Heart rate increased', 'Hypoaesthesia', 'Lethargy', 'Nausea', 'Paraesthesia', 'Pharyngeal paraesthesia', 'Pruritus', 'Retching', 'Tremor']",1,JANSSEN,SYR 1087969,IN,50.0,F,Started with fatigue and aching in the morning following the vaccination. Approximately 24 hours after the vaccination I had developed a fever that reached as high as 103F. By the next morning (a little over 36 hours later) I still had a fever of 100F but am feeling progressively better.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/09/2021,1.0,PUB,"SAM-E and turmeric supplements, Zyrtec allergy medicine",None,Arthritis,,Allergy to benzoin,"['Fatigue', 'Pain', 'Pyrexia']",1,JANSSEN,SYR 1087977,MD,26.0,F,"Fever, chills, body aches, headache, lightheaded",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/09/2021,03/10/2021,1.0,OTH,,,"Asthma, IBS",,Penicillin,"['Chills', 'Dizziness', 'Headache', 'Pain', 'Pyrexia']",UNK,JANSSEN, 1087983,MN,81.0,F,Acute inflammatory pericarditis with hospitalization from 3/7-3/10.,Not Reported,,Not Reported,Yes,3.0,Not Reported,,03/02/2021,03/05/2021,3.0,PVT,"Acetaminophen, Vitamin D3, Enalapril, Lexapro, Estradiol cream, Furosemide, Glimepiride, Probiotic, Imodium, Metoprolol, nystatin ointment and powder, potassium chloride, Trulicity, Rosuvastatin., Warfarin","UTI, completed course of gentamicin (completed end of Feb)","CHF, hyperlipidemia, Afib, hypertension, obesity, sleep apnea, DM type 2, osteoarthritis",,"Soma, Equagesic","['Angiocardiogram', 'C-reactive protein increased', 'Echocardiogram', 'Pericarditis', 'Red blood cell sedimentation rate']",2,PFIZER\BIONTECH,IM 1087994,IN,50.0,F,"Body aches, muscle pain, fever, headache, fatigue (started 8 hours post dose and lasted ~26 hours). Treated with acetiminophen at first signs and then introduced ibuprofen next day.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/08/2021,0.0,OTH,Estradiol patch,No,No,,None known,"['Fatigue', 'Headache', 'Myalgia', 'Pain', 'Pyrexia']",1,JANSSEN, 1088001,MD,33.0,M,Severe Chills/Sweats began on 02/18/2021 at approximately 02:00 AM Began having stomach pains in the early morning hours on 02/19/2021 (Approximately 04:00 AM) before vomiting. Went to the hospital later in the morning and was rushed into surgery for appendicitis.,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/17/2021,02/18/2021,1.0,UNK,None,None,None,,None,"['Abdominal pain upper', 'Appendicitis', 'Chills', 'Hyperhidrosis', 'Surgery', 'Vomiting']",2,PFIZER\BIONTECH,SYR 1088023,NH,80.0,M,Fatigue overall feeling blah nasal congestion cold sore on lower lip,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/10/2021,3.0,PVT,"namenda, sertraline, losartan, Vit C, D3, selenium, centrum silver",none,"lymphocytic vasculitis, hypertension, cognitive decline",,none,"['Fatigue', 'Feeling abnormal', 'Nasal congestion', 'Oral herpes']",1,JANSSEN,IM 1088034,IN,53.0,F,"Morning day 2: Onset of overwhelming tiredness, slight headache and some ""arthritis-like"" discomfort in my joints . I had Lyme disease about 5 years ago and it felt very similar to those initial symptoms. The elbow that was most affected by the Lyme disease was much more uncomfortable than other joints.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/09/2021,1.0,PUB,,,,,,"['Arthralgia', 'Fatigue', 'Headache']",1,JANSSEN,SYR 1088042,IA,17.0,M,Patient is 17 years of age,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/05/2021,03/05/2021,0.0,PUB,,,,,,['Product administered to patient of inappropriate age'],1,JANSSEN,IM 1088048,IN,46.0,F,"""right after the shot I got really lightheaded, but it went away in a few minutes. then about 2am (3/10) I started having hard chills, my temperature went up to around 102, I have body aches and headache still. missed work today""",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/09/2021,03/09/2021,0.0,OTH,,,,,wellbutrin,"['Chills', 'Dizziness', 'Headache', 'Impaired work ability', 'Pain', 'Pyrexia']",1,JANSSEN,IM 1088049,MA,57.0,M,"Medication Error NOT ADE COVID vaccine clinic. vaccinator reported to pharmacy that she believes she administered a dose of 0.1ml to a patient as opposed to the necessary 0.5ml that is required. Patient had left building by the time error was discovered. We were able to identify who the patient was who received the underdose. We contacted Janssen for recommendation on either administering the additional 0.4 mL dose or a full 0.5 mL dose. Janssen had no recommendations for partial dosing, split dosing and we were instructed to follow up as we felt most appropriate. We ultimately administered the additional 0.4 mL partial dose to the patient. In reviewing incident with involved Pharmacy staff, it appears that unintentionally a 1 mL syringe was given to this vaccinator amongst the standard 3 mL syringes used to administer the 0.5 mL dose. It was reported to me that the vaccinator self reported that when she was drawing up the intended dose of 0.5 mL she did not recognize that she was using a 1 mL syringe. Vaccinator drew the dose back to the first major marking on the syringe (0.1mL). On the 3 mL syringes the first major marking is 0.5 mL. The Pharmacy staff reported that the 1 mL syringe packaging and the 3 mL syringe packaging are nearly identical. After this incident Pharmacy staff segregated all 1 mL syringes to ensure 1 mL syringes were no longer supplied to any vaccinator. Going forward Pharmacy, whenever possible, will work to prevent any 1 mL syringes from being sent to a Moderna or J&J clinic were the doses are 0.5 mL.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/06/2021,03/06/2021,0.0,PUB,,,,,,['Incorrect dose administered'],1,JANSSEN,IM 1088051,,53.0,M,"Body Aches, Chills, headache, tired. Started at 11am then got worse as day progressed. Took Tylenol at 7. Heavy sweat (fever broke) at about 8pm. Felt a little better 10. Took Advil and went to sleep. Felt fine by 7am.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/08/2021,03/09/2021,1.0,UNK,Losartin Multi Vitamin,,,,,"['Chills', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Pain']",1,JANSSEN,SYR 1088069,,,F,"TIA; A spontaneous report was received from a nurse concerning a 76-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced TIA. The patient's medical history was not provided. Concomitant medications were Lipitor 10 and metformin. On 19 Feb 2021, the patient received their first dose of mRNA-1273 (Batch number: 00620) approximately one day prior to the onset of the symptoms for prophylaxis of COVID-19 infection. On 20 Feb 2021 patient was admitted to the hospital with TIA. On 21 Feb 2021 patient went undergone for Magnetic resonance imaging (MRI) and Echo cardio. The test results were not provided by the reporter. Treatment medication upon hospitalization included blood thinners and Lipitor 80. Action taken with the drug in response to the event was not reported. On 22 Feb 2021 patient was released from the hospital. The outcome of events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of TIA, a causal relationship cannot be excluded. Elderly age may have been contributory.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/19/2021,02/20/2021,1.0,UNK,LIPITOR; METFORMIN,,Medical History/Concurrent Conditions: Echocardiography; MRI,,,['Transient ischaemic attack'],1,MODERNA,OT 1088092,GA,72.0,F,Patient reported losing consciousness in the evening after the shot and being admitted to the hospital.,Not Reported,,Not Reported,Yes,,Not Reported,N,03/02/2021,03/02/2021,0.0,PHM,"Desvenlafaxine 25mg 1 po qd, Metformin 500mg 2 po bid, Synthroid 88mcg 1 po qd, Nadaolol 40mg 1 and one-half po qd, Dexilant 60mg 1 po qd, Nateglinide 120mg 1 po tid before meals, lantus 86 units sq hs",Unspecified upper respiratory infection,"Diabetes, heart burn, depression, thyroid disorder, high blood pressure",,NKDA,['Loss of consciousness'],2,MODERNA,IM 1088096,KS,68.0,F,"Fever, fatigue, runny nose the day after the 1st dose. . Pt deceased from COVID less than one month after 1st dose of vaccine",Yes,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/04/2021,1.0,PHM,,,"BiPolar, Dementia,",,,"['Death', 'Fatigue', 'Pyrexia', 'Rhinorrhoea']",1,PFIZER\BIONTECH,IM 1088112,MD,73.0,M,"03/05/2021: Increased SOB, DOE, increased HR and RR, pain on inhalation, agitation 3/06/2021: increased work of breathing, using accessory muscles, sweats, low-grade fever 3/07/2021- death",Yes,03/07/2021,Not Reported,Not Reported,,Not Reported,N,02/26/2021,03/05/2021,7.0,PVT,,,Pulmonary fibrosis CHF,,,"['Agitation', 'Death', 'Dyspnoea', 'Dyspnoea exertional', 'Heart rate increased', 'Hyperhidrosis', 'Painful respiration', 'Pyrexia', 'Respiratory rate increased', 'Use of accessory respiratory muscles']",UNK,MODERNA,IM 1088120,CO,78.0,F,"Called nurse line 4 days after 2nd Moderna vaccine, SOB, fainting, can't eat, dry cough, nose bleeds since shot. Advised to go to ED, patient refused as she feels a bit better today. Called again the following day with same symptoms - again advised to go to ED and quarantine for flu/covid-like symptoms. Patient agreed to come to ED, found to have bilateral PEs and RLE DVTs. Covid/flu negative. LUE red/swollen at injection site - no cellulitis. Admitted overnight and d/c'd home the following day.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/20/2021,02/21/2021,1.0,PVT,,,"diabetes, h/o afib w/ ablation, hypothyroid, cataracts, depression, sleep apnea,",,"morphine, statins","['Cough', 'Deep vein thrombosis', 'Dyspnoea', 'Epistaxis', 'Feeding disorder', 'Influenza like illness', 'Influenza virus test negative', 'Injection site erythema', 'Injection site swelling', 'Pulmonary embolism', 'SARS-CoV-2 test negative', 'Syncope']",2,MODERNA,IM 1088136,TX,55.0,F,"Right after the vaccination ion Friday, I felt fatigue. (at the 15 minutes wait time), I left the facility at 130, Took Prednisone 20 mg per my pulmonologist request at 235pm. I felt the lungs are heavy, by around 545 pm, I started to have shortness of breath, at 11 pm that evening, wheezing started. I started xopenex, and atrovent neb solution and tylenol for the headache (which started around time of wheezing) By Saturday afternoon, the ribcage is very tight, hard for me to breath, can only take short breath. I continue to take prednisone 20 mg daily per doctor. On Monday, telemedicine visit with the pulmonologist, he increase to 60 mg, Ribcage tightness relieved about 1 hour and 45 minutes, back to tightness again. Tuesday morning, I went to Emergency room, admitted as observation. Discharged on Thursday. I was given iv solumedrol while under observation in the hospital. I return home with oral prednisone prescription. I feel fine on Friday, Saturday, the ribcage started to tighten again, along with shortness of breath. Doctor contacted on Monday 3/8/21 with continuation of prednisone and taper down by 10 mg a week. I am still having shortness of breath and ribcage tightness, especially, when walk, stand, talk. As of now, I am still home and have not return to work.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/26/2021,02/26/2021,0.0,PUB,"brovana, pulmicort, dexilant, pepcid, tudorza, proair, vitamin d, vitamin b12 . after the vaccination, i took prednisone per my pulmonologist since I had shortness of breath a day after the first dose.",asthma flare up by the first dose of moderna vaccine.,asthma,,"Penicillin, ibuprofen, toradol, levaquin, avelox, peanuts, scollop, breo","['Chest discomfort', 'Dyspnoea', 'Fatigue', 'Headache', 'Impaired work ability', 'Lung disorder', 'Wheezing', 'X-ray']",2,MODERNA,IM 1088175,IL,65.0,F,death within 30 days of vaccination,Yes,02/18/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/18/2021,15.0,OTH,Unknown,"Chronic conditions with acute flare ups, last paracentesis for chronic ascites 1/28/2021.","NASH Cirrhosis, Diabetes, Multiple paracentesis for chronic ascites, back pain, depression, dyslipidemia",,Amoxicillin and codeine,"['Ascites', 'Blood potassium increased', 'Condition aggravated', 'Death', 'Intensive care', 'Paracentesis']",1,PFIZER\BIONTECH,IM 1088180,AR,93.0,M,Patient was admitted to Hospice on 8/11/20. He experienced normal progression of his diseases until his death on 3/9/21.,Yes,03/09/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/09/2021,4.0,OTH,,See Below,"On Hospice due to: Chronic systolic (congestive) heart failure, Chronic kidney disease stage 3, Sick sinus syndrome, Unspecified atrial fibrillation, Presence of cardiac pacemaker, Muscle weakness, Alzheimer's Disease",,NKA,['Death'],1,MODERNA,IM 1088184,CA,56.0,M,Pronounced dead on 3/9/21 approximately 72 hours after receiving vaccination. Unknown symptoms prior.,Yes,03/09/2021,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/09/2021,3.0,PUB,"Furosemide, Omeprazole, Xarelto, Vitamin D3, Propranolol, Sucralfate, Spironolactone",Unknown,"Seizures, unknown",,NKA,['Death'],1,MODERNA,IM 1088210,MA,46.0,F,"Patient presented to BIDMC on 02/23/21 with ~5d of sore throat and intractable fever and was found to have fulminant myocarditis. She required ICU stay with VA ECMO and Impella circulatory support from 02/25/21-03/03/21. She received a course of hydrocortisone. Cause of myocarditis was unclear but felt to be viral or post-viral versus inflammatory. As of this submission she has been transferred to the cardiac floor and seems to be recovering. Symptoms started ~14d after 1st dose COVID vaccine. She also had self limited COVID infection in early January, 2021.",Not Reported,,Yes,Yes,20.0,Not Reported,Y,02/05/2021,02/23/2021,18.0,PVT,1. Aspirin 81 mg PO DAILY 2. Atorvastatin 10 mg PO QPM 3. Vitamin D Dose is Unknown PO DAILY 4. Ascorbic Acid Dose is Unknown PO DAILY,"Experienced mild COVID-19 infection (loss of taste/smell) in January, 2021 - diagnosed January 5th. Cleared to return to work 01/25/21.",None,,Clindamycin: skin rash,"['Adenovirus test', 'Cytomegalovirus test negative', 'Epstein-Barr virus antibody', 'Epstein-Barr virus antigen positive', 'Epstein-Barr virus test positive', 'Intensive care', 'Myocarditis', 'Oropharyngeal pain', 'Pyrexia', 'Respiratory viral panel', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH,IM 1088216,IL,67.0,F,Death within 30 days of vaccination,Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/24/2021,21.0,SEN,Unknown,"Unknown prior to first dose; in between first and second dose Hospitalization for UTI with septic shock, hypothermia; metabolic encephalopathy; severe metabolic acidosis",Anemia; apnea; arthritis; back pain; bladder problem; CHF; Depression; Diabetes; Difficulty swallowing food; dyslipidemia; falls; fistula; gout; headaches; hypertension; low back pain with neurostimulator in spine; Nonsustained v. tach 2019; obesity; peptic ulcer; pneumonia 2019; spinal stenosis; CKD stage III.,,Adhesive bandage; adhesive tape; cephalexin; cipro; latex; motrin; NSAIDS; Paxil; Sulfa; Zosyn,['Death'],1,PFIZER\BIONTECH, 1088274,CA,24.0,M,"Loss of hearing in both ears; Fatigue; Joint pain; Headache; A spontaneous report was received from a Healthcare Professional concerning a 24 years old male patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced fatigue, joint pain, headache and loss of hearing in both ears. The patient's medical history was not provided. Products known to have been used by the patient were Tylenol and Ibuprofen. On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient experienced the events fatigue, joint pain and headache. On 28 Jan 2021, the patient experienced the loss of hearing in both ears. The patient was treated with Tylenol and Ibuprofen. No relevant laboratory details were included. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events include fatigue, joint pain and headache were unknown. The outcome of the event loss of hearing in both ears was not recovered.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/27/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Arthralgia', 'Deafness', 'Fatigue', 'Headache']",1,MODERNA,OT 1088287,PR,91.0,M,"The caregiver on duty tells the nurse in charge that on 5/3/2021 she proceeds to bathe the resident and he was disoriented, so she goes to bed at around 5:00 a.m. The resident expresses that he feels bad, when the caregiver goes to look for things to take vital, when he returns she finds him without vital signs and was presenting respiratory problems.",Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,02/09/2021,03/05/2021,24.0,SEN,"Temazepan 30 mg, Dexin, Bupropion, Sertraline 50 mg, Clonazepam, Difenhidramina 50mg, Valsartaan, Metroprolol, Omega 3, Nifedipine",None,"High blood pressure, Alzheimer, cardiovascular disease, had suffer from heart failure",,None were reported,"['Disorientation', 'Feeling abnormal', 'Respiratory disorder']",2,MODERNA,IM 1088297,PA,61.0,M,"Next day developed right leg pain. Following day diagnosed with a new deep venous thrombosis of the popliteal vein, right leg",Not Reported,,Yes,Not Reported,,Not Reported,Y,03/03/2021,03/04/2021,1.0,PVT,"Topamax, Enalapril, Metoprolol, aspirin, rosuvastatin",none,"hypertension, hyperlipidemia, migraine variant headaches",,none known,"['Deep vein thrombosis', 'Pain in extremity', 'Ultrasound Doppler abnormal']",1,MODERNA,IM 1088320,KS,85.0,M,Pt tested positive for COVID on 2/6/2021. Deceased on 2/15/21. Not marked COVID death on death certificate.,Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/06/2021,3.0,PHM,,Cancer,,,,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 1088328,PR,91.0,F,"The caregivers in their rounds indicates that resident was well, ate his meals and her vitals were taken. In their next 7:30 pm rounds they find that the resident was not breathing. Home physician certifies death as Congestive Heart Failure.",Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,SEN,"Zoloft, Donepezil, Lanoxine, Furosemide, Imdur, Cozaar, Aldactone, Coreg, Pestoril, Pepcid",,"Heart Failure, Hypertension, Osteoporosis, Memory Loss",,None were reported,"['Cardiac failure congestive', 'Death', 'Respiratory arrest']",1,MODERNA,IM 1088338,OR,72.0,F,"Case received vaccines 12/23/2020, and 01/13/2021. Public Health received notification that patient died 3/5/2021. Not really sure if her death is related to vaccine administration but I was instructed to fill out this form.",Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,U,01/13/2021,03/05/2021,51.0,SEN,Unknown,,"COPD, Chronic Bronchitis, Pulmonary Nodular Angloidosis, Morbid Obesity BMI >70, Obesity Hypoventilation Syndrome, Chronic Diastolic Heart Failure, Anemia, Osteoarthrosis, Dyslipidemia.",,,['Death'],2,PFIZER\BIONTECH,IM 1088358,KS,89.0,F,"History of Present Illness 89-year-old female with past medical history significant for osteoporosis and hypothyroidism, who initially presented to ER on March 2 due to lower extremity weakness and right knee pain after a recent fall. Patient lost her balance and suffered a mechanical fall on February 22. Patient developed right lumbar and hip pain radiating down her leg. She saw Dr from orthopedics on February 26 who recommended offloading knee and wearing a knee immobilizer. Patient was admitted to hospital on March 2 due to worsening knee pain and was incidentally found to be positive for COVID-19. Patient had received her second Moderna COVID-19 vaccination on February 26. Patient was evaluated by neurology during that hospital course, who recommended outpatient EMG, physical therapy, and pain management. No evidence of Guillain-Barr� or viral induced neuropathy. Patient's lower extremity weakness did improve, and she was successfully discharged home with family and home health on March 5. Patient reports doing well at home with family initially, was making improvements with her strength and was able to stand and take a few steps with walker and assistance. On March 8, patient was in bed and she attempted to turn onto her right side, and as she was turning she felt a pop and a pain in her right hip that radiated down her right leg. Since that time, patient reports having severe pain with movement, rates pain as 8/10 severity. Denies falls or new trauma since her previous fall from February 22. Patient was unable to control pain at home, so she came into the emergency department for evaluation. Initial hip x-ray series revealed questionable greater trochanteric fracture. CT of right hip subsequently revealed fracture. Orthopedics consulted. No significant laboratory abnormalities. Foley catheter was placed in ER. Patient was admitted to hospital service for management. On my interview, patient reports that right hip pain is under good control as long as she does not move, but has 7/10 pain severity over her right lateral hip with movement. Patient reports following Covid isolation protocols at home with family. Reports that her Covid isolation will be completed on March 12. Denies upper respiratory symptoms. Patient has oxygen saturations of 100% on room air.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/26/2021,03/02/2021,4.0,PVT,,,"Asthma, COPD, hypothyroidism, hyperlipidemia",,"Morphine, Naproxen","['Arthralgia', 'Bladder catheterisation', 'COVID-19', 'Hip fracture', 'Muscular weakness', 'Pain', 'Pain in extremity', 'SARS-CoV-2 test positive', 'Walking aid user', 'X-ray of pelvis and hip abnormal']",2,MODERNA,UN 1088359,NC,84.0,M,Our patient received dose 1 of the Moderna COVID19 vaccine on 2/12/21 and he was diagnosed with COVID19 on 3/9/21. Patient admitted to the hospital for a diabetic foot infection and COVID19 was diagnosed upon admission.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/01/2021,03/09/2021,36.0,PVT,"albuterol, aspirin, atorvastatin, brimonidine, brinzolamide, BREO ELLIPTA, omeprazole, miralax, Flonase, metronidazole, senokot-s",diabetic foot infection,"? Abnormal finding on GI tract imaging 2/18/2020 A. CT chest without contrast January 17, 2020: IMPRESSION 1. Patulous esophagus, bronchial wall thickening and debris within the left mainstem bronchus suggestive of aspiration. 2. Cystic lesions in the left lower lobe of uncertain etiology, likely benign, possibly sequela of aspiration or prior infection. 3. Low attenuation lesion within the right hepatic lobe and multiple sept ? Ambulates with cane ? Anemia ? At risk for falling ? Chronic obstructive pulmonary disease (CMS-HCC) ? Former smoker ? GERD (gastroesophageal reflux disease) ? Glaucoma ? History of hypertension ? History of iron deficiency anemia ? Hyperlipidemia ? Hyperlipidemia associated with type 2 diabetes mellitus (CMS-HCC) ? Low serum vitamin B12",,no known drug allergies,"['COVID-19', 'Diabetic foot infection', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1088362,IL,34.0,F,"Onset of symptoms 1-2 days after 2nd Pfizer Dose. Presented to ER with fever, myalgia, headache, mild thrombocytopenia/leukopenia, elevated hepatic function test. Also noted mild swelling of upper eyelids.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,02/28/2021,03/01/2021,1.0,PVT,,,,,Penicillin - unknown reaction,"['Alanine aminotransferase increased', 'Antinuclear antibody positive', 'Aspartate aminotransferase increased', 'Cytomegalovirus test negative', 'Epstein-Barr virus antibody positive', 'HIV test negative', 'Headache', 'Leukopenia', 'Liver function test increased', 'Myalgia', 'Platelet count decreased', 'Pyrexia', 'SARS-CoV-2 test negative', 'Swelling of eyelid', 'Thrombocytopenia', 'White blood cell count decreased']",2,PFIZER\BIONTECH,IM 1088365,KS,85.0,F,Pt tested positive for COVID on 02/29/2021. Passed away on 02/25/2021. COVID listed on death certificate.,Yes,02/25/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/09/2021,6.0,PHM,,,,,,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 1088367,PR,98.0,F,"Person of contact spent around 10 minutes in the room, spoke with the resident, left the room. When the caregiver came into the room with the resident lunch the resident was without vital signs. Dxn: Atherosclerotic Heart Diseases",Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/24/2021,20.0,SEN,"Synthroid, Prilosec, Imdur, ASA, Valium, Lipitor, Toprol, Vitamin d3 10,000 Units, Remeron, Restoril, Fosamax, Norvasc, Iron vitamin, Buspar, Seroquel",,"Hypothyroidism, Diabetes, Osteoporosis, Chronic Ischemic Heart Disease, Bedridden",,None were reported,['Arteriosclerosis'],1,MODERNA,IM 1088389,NC,71.0,M,"Profound Weakness, confusion",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,03/08/2021,03/09/2021,1.0,PVT,"Divalproex Sodium ER, Hydrochlorothiazide, Pravastatin, Potassium Chloride, Metoprolol Succinate XL, Carbidopa/Levodopa, Ondansetron, Apixaban",,"Hypertension, Parkinsonism, Bipolar Disorder",,No,"['Asthenia', 'Confusional state']",2,MODERNA,IM 1088401,KS,96.0,F,Pt tested positive for COVID on 2/15/21. She passed away on 02/23/21. Not listed as COVID death on death certificate.,Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/15/2021,12.0,PHM,,,,,,"['COVID-19', 'Death', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 1088457,TX,53.0,M,"Diagnosed with Covid-19 on 03/01/2021. Admitted to hospital ICU on 03/01/2021. Presented with dyspnea, fatigue, shortness of breath. Patient had skipped dialysis treatments for an unknown amount of days. DIscharged from hospital on 03/04/2021. Total number of days: 4. Treated with Vitamin C, Vitamin E, Vit D, zithromax 500mg daily x 7 days; Zinc 50mg; dexamethasone 4mg x 10 days; Tussin DM; acetaminophen 500mg as needed. Currently in isolation for 21 days (03/01/2021 to 03/22/2021). Pt reported Symptoms resolved on 03/04/2021. Continues with Dialysis although schedule days have temporarily changed to Tuesday, Thursday and Saturdays until cleared from Covid-19.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/08/2021,03/01/2021,21.0,PVT,Velphoro 500mg chew 2 tablets everyday with meals,Rhinovirus; Treated for Cough on 2/23/2021,End Stage Renal Disease Vit D deficiency Osteopenia hyperlipidemia Hypertension Impaired Fasting glucose,,NKA,"['COVID-19', 'Dyspnoea', 'Fatigue', 'Human rhinovirus test positive', 'Intensive care', 'Respiratory viral panel', 'SARS-CoV-2 test positive']",2,MODERNA,IM 1088463,TX,61.0,F,I started with headache then got nausea and started running fever. Over 24 hr period I was constantly vomiting. I went to the hospital on Sunday stayed for 5 days.,Not Reported,,Not Reported,Yes,5.0,Not Reported,Y,12/31/2020,01/06/2021,6.0,PVT,"Vit D, Zanaflex, Plavix, Estradiol, Nifedipine, Crestor,Temazepam, Pantoprazole, Metoprolol, Irbesartan, Mser,Msir",No,"Retroperitoneal Fibrosis, RSD Reflux, Hypertension, Neuropathy",Prevnar 13(arm swelling 2 yrs ago),Gentamicin,"['Echocardiogram', 'Full blood count', 'Headache', 'Laboratory test', 'Magnetic resonance imaging', 'Nausea', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 1088480,CA,71.0,F,Had a stroke,Not Reported,,Yes,Yes,3.0,Yes,N,02/02/2021,03/06/2021,32.0,OTH,Several,none known,fibromyalgia,,none known,['Cerebrovascular accident'],1,PFIZER\BIONTECH,SYR 1088508,MI,67.0,M,"diarrhea; 12 hours after injection - fainted in bathroom/fainted 2nd time; woozieness when trying to walk/just felt woozy; headache; chills; This is a spontaneous report from contactable consumers (patient and wife). This 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6202) in right arm on 23Feb2021 05:00pm at single dose for COVID-19 immunisation. Medical history included high cholesterol, acid reflux (esophageal). The patient had no known allergies. Concomitant medications in two weeks included atorvastatin for high cholesterol, ongoing omeprazole for acid reflux (esophageal), and ongoing multivitamins (1 tablet a day for men over 50 by mouth as supplementation therapy). The patient did not receive other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EM9810) at the age of 67-year on 02Feb2021 at 05:00PM in left arm at single dose for COVID-19 immunisation, had no reaction with the first dose, had no issues in the waiting period or while shopping afterwards; received influenza vaccine (FLU) and pneumonia shot for immunization on an unknown date a couple of months ago. The patient did not have COVID prior vaccination, COVID was not tested post vaccination. The patient received second dose of the Covid-19 Vaccine, then on 24Feb2021, fainted twice 12 hours after receiving the second dose, fainted in the morning of 24Feb2021 around 05:20, he got up because he had diarrhea and that was when he first fainted in the bathroom. He also had chills and a headache in the morning of 24Feb2021 at 05:15, but she reported that he did not have a fever. Temperature was normal on 24Feb2021. The patient reported that he just felt woozy, wooziness when trying to walk/just felt woozy in the morning of 24Feb2021 at 05:15. She said that he fainted for a second time just minutes after he fainted the first time when the reporter was helping the patient get back from the bathroom to the bedroom, the patient collapsed on the floor and reporter got him up. He developed the diarrhea around 05:30 in the morning of 24Feb2021. He took some ibuprofen to treat the headache. It was unknown if the treatment received for the other events. He has been resting since he had the diarrhea. Outcome of the events faint and diarrhea was unknown, wooziness when trying to walk/just felt woozy was recovering, while other events was recovered on 24Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/24/2021,1.0,PHM,ATORVASTATIN; OMEPRAZOLE,,Medical History/Concurrent Conditions: Acid reflux (esophageal); High cholesterol,,,"['Body temperature', 'Chills', 'Diarrhoea', 'Dizziness', 'Headache', 'Syncope']",2,PFIZER\BIONTECH, 1088509,CT,76.0,F,"Lost consciousness; palms began to itch, then soles of feet; This is a spontaneous report from a consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (lot number was EL8982 and expiration date was unknown) via an unspecified route of administration at left arm 18Jan2021 14:30 at single dose for COVID-19 immunisation, amoxicillin via an unspecified route of administration from 18Jan2021 at 14:50 at 4 DF for dental apt, procaine hydrochloride (NOVOCAIN) via an unspecified route of administration from 18Jan2021 at unknown dosing regimen for an unspecified indication. Medical history included 3 joint replacements and known allergies to raw celery, clover honey and ragweed. Concomitant medication included atorvastatin calcium (ATORVASTIN), brimonidine tartrate, timolol maleate (COMBIGAN), levothyroxine, tolterodine. There was no other vaccine in four weeks. Patient did not have COVID prior vaccination. The patient had no reaction in first 15 minutes. Within 20 minutes of shot, patient took 4 amoxicillin for dental apt (as reported), then received procaine hydrochloride (Novocain). 45 min after shot, her palms began to itch, then soles of feet. Then she total loss of sight on 18Jan2021 at 15:30. Patient lost consciousness at emergency room check-in. Patient visited emergency room/department or urgent care. Patient received epinephrine injection as treatment. She also had CT scan of head and chest in Jan2021. She did not have COVID tested post vaccination. The outcome of events was recovered in 2021. The action taken in response to the events for amoxicillin and procaine hydrochloride was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/18/2021,01/18/2021,0.0,PVT,ATORVASTIN; COMBIGAN; LEVOTHYROXINE; TOLTERODINE; Amoxicillin; NOVOCAINE,,Medical History/Concurrent Conditions: Food allergy; Joint replacement (3 joint replacements); Ragweed allergy,,,"['Computerised tomogram head', 'Computerised tomogram thorax', 'Loss of consciousness', 'Pruritus']",1,PFIZER\BIONTECH, 1088516,WI,62.0,M,"hospitalization for cough, fever and acute change in mental status",Not Reported,,Not Reported,Yes,,Not Reported,N,03/08/2021,03/09/2021,1.0,PVT,"APAP, aspirin, vitamin B complex, melatonin","recent hospitalization for pneumonia, recent PE on warfarin, covid diagnosed on 1/21","ESRD on dialysis TTS , DM, HTN",,none,"['Cough', 'Mental status changes', 'Pyrexia']",2,MODERNA,IM 1088525,KS,76.0,F,2nd vaccine dose received on 2/3/21. Pt tested positive for COVID-19 on 2/8/21 and was hospitalized. Our has little information regarding this patient due to her living in a long-term care facility.,Not Reported,,Not Reported,Yes,,Not Reported,U,01/13/2021,02/03/2021,21.0,PHM,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 1088539,OR,58.0,M,"He was found unresponsive, cold and with rigor mortis present after family requested welfare check. He had not been seen for 36 hours.",Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/24/2021,13.0,OTH,Lactulose 22.5 ml tid; omeprazole 40 mg daily; rifaximin 550 mg bid,end stage liver disease due to alcoholic cirrhosis with undiagnosed liver mass; chronic hepatitis C.; and hepatic encephalopathy,"alcoholism; hepatitis c with end stage liver disease and hepatic encephalopathy, macrocytic anemia, poly-substance abuse, non-compliant with medical treatment",,none,"['Muscle rigidity', 'Peripheral coldness', 'Unresponsive to stimuli']",1,MODERNA,IM 1088541,WA,74.0,M,2 days after vaccine went to the ED --SOB 85%o2 sat cough wheezy-- Blood sugar elevated to 480-Tachacardia CHF EKG showed New onset A-fib withRVR troponin elevated to 0.75 the to 2.9-- Airlifted to facility,Not Reported,,Yes,Not Reported,,Not Reported,U,,02/19/2021,,PVT,,,,,,"['Atrial fibrillation', 'Blood glucose increased', 'Cardiac failure congestive', 'Cough', 'Dyspnoea', 'Electrocardiogram abnormal', 'Laboratory test', 'Tachycardia', 'Troponin increased', 'Wheezing']",UNK,MODERNA, 1088612,NE,46.0,F,"got vaccine - about a week later - she sent us a message saying ""I have been having right calf pain for about a week or more. I have more increased SOB and chest pain."" was able to get ddimer which was elevated - and was admitted to the hospital for this since her vaccine - she has noticed increased chest tightness, SOB, hairloss, DVT/PE.",Not Reported,,Yes,Yes,1.0,Not Reported,N,12/18/2020,12/18/2020,0.0,OTH,xanax - rprn rare usage amlodipine 5mg calcium carbonate/vit d 3 cymbalta flonase folic acid lasix prn depo methotrexate toprol xl prilosec potassium supplement with lasix usage prednisone prn crestor trazodone,mostly chronic - she does have an auto immune disease unspecified - she does have hx of clots - associated with estrogen birth control - has been great on depo for 2+ years - raynauds - tremors - reflux - fibromyalgia,see above,,atorvastatin - muscle aches - tolerates crestor morphine - swelling sulfa antibiotics - gave rash,"['Alopecia', 'Chest discomfort', 'Chest pain', 'Computerised tomogram abnormal', 'Deep vein thrombosis', 'Dyspnoea', 'Fibrin D dimer increased', 'Pain in extremity', 'Pulmonary embolism', 'Ultrasound Doppler abnormal']",1,PFIZER\BIONTECH,IM 1088615,IL,59.0,F,"Death within 30 days of vaccination, vaccinated on 3/5/2021 pronounced dead on 3/6/2021. Unknown if any side effects from vaccine. No ER visit found at local hospital.",Yes,03/06/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,OTH,Unknown,Unknown,"Carotid Artery Bruit, Smoker, HTN, family hx of cardiovascular disease Sister MI at 56. 11/2015 Abnormal Stress Echo with elevated values on a lipid profile after c/o chest pain. Other medical history unknown.",,"Morphine, Allegra, and Bee Stings",['Death'],2,MODERNA,IM 1088627,OH,63.0,F,Muscle wasting and weakness Fatigue,Not Reported,,Not Reported,Not Reported,,Yes,N,02/03/2020,02/15/2020,12.0,PVT,Fish oils L-Theanine Licorice Bacopa Vitamin D Calcium and Magnesium Multi vitamin and Multi Mineral Thyroid hormone replacement,None,Hypothyroid,,Gluten,"['Asthenia', 'Blood creatine phosphokinase', 'Blood lactate dehydrogenase', 'Fatigue', 'Metabolic function test', 'Muscle atrophy', 'Myoglobin urine']",2,MODERNA,IM 1088636,SD,74.0,F,fluid leakage in retina (conversion to wet AMD),Not Reported,,Not Reported,Not Reported,,Yes,U,02/18/2021,02/21/2021,3.0,PHM,"PPI, Ca, glucosamine, cinnamon, turmeric, multivitamin, vitamin C, lutein",none,,,none,['Neovascular age-related macular degeneration'],1,PFIZER\BIONTECH,IM 1088643,TN,74.0,M,Was driving a vehicle and started having vision problems and pulled off road and started loosing consciousness. 911 dispatched and taken to hospital.,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,03/03/2021,03/04/2021,1.0,PUB,"Plavix, Ramipril,",allergy symptoms of running nose,High BP,,Penicillin,"['Blood test normal', 'Computerised tomogram head normal', 'Impaired driving ability', 'Loss of consciousness', 'Magnetic resonance imaging normal', 'Ultrasound Doppler normal', 'Visual impairment', 'X-ray limb normal']",1,MODERNA,IM 1088686,,67.0,M,Pt found deceased in home on 03/07/2021,Yes,03/07/2021,Not Reported,Not Reported,,Not Reported,,03/04/2021,03/07/2021,3.0,UNK,,,,,,['Death'],1,MODERNA,IM 1088723,TX,28.0,M,"Patient had 2nd COVID vaccine on 2/21/2021. He started having a temperature on 2/24/2021. Patient then started having trouble breathing. We took him to hospital. He was admitted on 2/25/2021. He steadily declined and was sent to ICU and died on March 1, 2021.",Yes,03/01/2021,Not Reported,Yes,5.0,Not Reported,N,02/21/2021,02/24/2021,3.0,PVT,"Levothyroxin, Depakote, Sertraline, Trazodone, Risperidone, Vit D3",,"Down Syndrome, Autism, CKD, ITP",,Augmentin,"['Blood test', 'Body temperature increased', 'Chest X-ray', 'Computerised tomogram', 'Death', 'Dyspnoea', 'General physical health deterioration', 'Intensive care', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,SYR 1088741,NY,85.0,F,Patient found unresponsive approx 16 hours after vaccination. Death listed as Cardiac arrest secondary to stenosis. Patient had inoperable cardiac issues and was reportedly in a terminal state.,Yes,02/27/2021,Not Reported,Not Reported,,Not Reported,N,02/26/2021,02/27/2021,1.0,OTH,unknown,"multiple cardiac issues, arterial/aortic stenosis",aortic stenosis,,unknown,"['Cardiac arrest', 'Death', 'Stenosis', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 1088749,MO,41.0,M,"He received first dose of Pfizer COVID vaccine 1/15. Next day, he felt right axilla and trunk numbness after that which lasted 2-3 weeks and was resolving. After the second dose early Feb 5th, he started having difficulty swallowing and SOB and felt a little better after a course of steroids and antibiotics but got a lot worse after finishing the course and presented to ED 2/16 and was found to have supraglottic edema requiring intubation and treatment with IV steroids. Was extubated on 2/19, in ICU until 2/21. He did well with treatment and was discharged 2/22. Patient received a dose of influenza vaccine (FLULAVAL - GSK lot: 7N43B) on 2/22/21 3/2 he started having burning pain in the right midthoracic area, the next day he noticed right hand weakness/numbness (4th and 5th digits), gradually progressed. 3/4 noticed right facial weakness, initially was lower face, Unable to drink without drooling. MRI brain was done 3/5 and was normal. 3/5 facial weakness progressed to upper face. Unable to close right eye for the last 24 hrs. He also reports numbness left 5th digit. Presented to the ED on 3/6. Found to have elevated transaminase in ED. Hospitalization continues at this time. Etiology of symptoms is unknow, but includes vaccine reaction, shingles or early stages of autoimmune disease.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/05/2021,02/16/2021,11.0,PVT,,,"seasonal allergies, herniated disc",,morphine - itching,"['CSF test normal', 'Chest pain', 'Culture negative', 'Drooling', 'Dysphagia', 'Dyspnoea', 'Endotracheal intubation', 'Extraocular muscle paresis', 'Eyelid function disorder', 'Facial paresis', 'Hypoaesthesia', 'Intensive care', 'Laboratory test normal', 'Laryngeal oedema', 'Magnetic resonance imaging head normal', 'Muscular weakness', 'Pain', 'Transaminases increased']",2,PFIZER\BIONTECH,UN 1088754,PA,29.0,F,"I received the first dose of my moderna vaccine on February 9th. for 48 hours I had a sore left arm, where the vaccine was administered. On February 14th I started experiencing paresthesias of the bilateral soles of my feet. Over the next couple of days the paresthesias were worsening and moving proximally until they were in both my lower extremities. They remained in my bilateral lower extremities for several days without moving further. On February 21st around 11 pm I felt the paresthesias move up my posterior legs into my buttocks, up my back, and down my bilateral arms. I went to sleep and woke up on February 22nd and felt rectal pressure and increased saddle paresthesias and became concerned. I went to Hospital ED on February 22nd around 9 am.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/09/2021,02/14/2021,5.0,PVT,"zyrtec 10 mg qd prenatal vitamin Naproxen 375mg, tramadol 50 mg, and 2 tylenol tabs (2 doses per month with menses)",None,Endometriosis Seasonal allergies,,None,"['Angiotensin converting enzyme', 'Anorectal discomfort', 'Antinuclear antibody', 'Blood 25-hydroxycholecalciferol', 'Blood magnesium', 'Blood thyroid stimulating hormone', 'Borrelia test', 'C-reactive protein', 'CSF oligoclonal band', 'CSF test', 'Full blood count', 'Glycosylated haemoglobin', 'Influenza virus test', 'Lumbar puncture', 'Magnetic resonance imaging head', 'Magnetic resonance imaging spinal', 'Metabolic function test', 'Pain in extremity', 'Paraesthesia', 'Prothrombin level', 'Prothrombin time', 'SARS-CoV-2 test', 'Troponin', 'Urine analysis', 'Vitamin B1', 'Vitamin B12']",1,MODERNA,IM 1088758,AZ,73.0,F,"Severe pain in shoulder down arm, Unable to lift arm, This has been contiuing now for the eighth day.",Not Reported,,Not Reported,Not Reported,,Yes,N,03/01/2021,03/01/2021,0.0,UNK,"Atrovastatin, Calcium, Olmesartan Medoxomil, chlorthalidone, Prilosec",no,No,,none,"['Arthralgia', 'Mobility decreased', 'Pain in extremity']",1,MODERNA,IM 1088767,SC,73.0,M,"Patient received second Covid vaccine 3 days prior to admisssion. He presented to the emergency department for worsening shortness of breath, cough, decreased appetite, and generalized weakness for about 2 to 3 days associated with diffuse abdominal colicky pain. He reports of a progressively worsening weakness/fatigue over the last 3 days associated with poor oral intake with nausea but no vomiting.",Not Reported,,Not Reported,Yes,,Not Reported,N,03/01/2021,03/06/2021,5.0,PVT,amlodipine-benazepril 10mg/40mg 1 capsule by mouth daily atenolol 100mg 1 tablet by mouth daily cloNIDine 0.1mg 1 tablet by mouth three times daily lovastatin 20mg 1 tablet by mouth every night at bedtime meloxicam 15mg 1 tablet by mouth ev,,Diabetes mellitus Hyperlipidemia Hypertension,,No known allergies,"['Abdominal pain', 'Asthenia', 'Blood creatine phosphokinase increased', 'Blood culture', 'Blood lactate dehydrogenase increased', 'Blood lactic acid', 'C-reactive protein increased', 'Cough', 'Decreased appetite', 'Dyspnoea', 'Fatigue', 'Fibrin D dimer increased', 'Nausea', 'Red blood cell sedimentation rate increased', 'SARS-CoV-2 test negative', 'White blood cell count increased']",2,PFIZER\BIONTECH, 1088815,TN,78.0,M,"PER MEDICAL RECORDS PATIENT PRESENTED TO ER VIA EMS REPORTING INTERMITTENT CHEST PAIN, FEELING LIKE HIS HEART WAS STOPPING.",Yes,02/22/2021,Not Reported,Yes,1.0,Not Reported,N,02/18/2021,02/21/2021,3.0,PUB,"AMLODIPINE-BENAZEPRIL 5-10MG 1 CAPSULE BY MOUTH DAILY; ASPIRIN 81 MG, TAKE 1 CHEWABLE TABLET DAILY; GLIMEPIRIDE 2MG, TAKE 1 TABLET DAILY WITH BREAKFAST",UNKNOWN,"CHRONIC KIDNEY DISEASE, HYPERTENSION, HYPERLIPIDEMIA, SINGLE KIDNEY, RENAL CANCER, DIABETES,",,NO KNOWN ALLERGIES,"['Arterial catheterisation', 'Cardiac pacemaker insertion', 'Cardio-respiratory arrest', 'Central venous catheterisation', 'Chest pain', 'Death', 'Electrocardiogram', 'Troponin increased']",2,PFIZER\BIONTECH,IM 1088830,TX,50.0,M,Patient died after feeling unwell for about ten minutes.,Yes,03/08/2021,Yes,Not Reported,,Not Reported,N,03/03/2021,03/08/2021,5.0,PHM,Metformin Vitamins Calcium,,Diabetes Blood pressure,,None,"['Death', 'Malaise']",1,MODERNA,SYR 1088837,FL,64.0,F,"Patient received first vaccine dose on 3/10/21, waited for approximately 1 hour in Pharmacy after. Was walking to her vehicle and became short of breath. Patient got to her vehicle and called 911 due to severe shortness of breath. Rescue arrived on scene at approximately 11:00am, found patient in distress and administered epinephrine, methylprednisolone, and diphenhydramine. Patient placed on CPAP in rescue en route to ER, became unresponsive, frothing pink sputum. Intubated by paramedics en route with iGel device. Patient arrived to ER at 11:22am, went into cardiac arrest at 11:24am. Patient continued to be unstable, had multiple rounds of cardiac arrest and ROSC. Patient ultimately did not survive arrests, and pronounced dead at 2:37pm. Medications received during course in the ER - epinephrine 1mg x18 doses, sodium bicarbonate 50mEq x4 doses, calcium chloride 1g, insulin regular 10 units x1, furosemide 80mg x1, epinephrine titrated infusion, sodium bicarbonate infusion.",Yes,03/10/2021,Not Reported,Yes,,Not Reported,N,03/10/2021,03/10/2021,0.0,PVT,"albuterol, alprazolam, amlodipine, aspirin, bumetanide, vit D, clopidogrel, escitalopram, ezetimibe, fenofibrate, ferrous gluconate, insulin aspart, insulin glargine, metoprolol tartrate, multivitamin, potassium chloride, ranolazine, rosuva",chronic conditions only noted - most recent was a TAVR procedure completed on 11/20/2020,"Diabetes mellitus, essential hypertension, hyperlipidemia, obstructive sleep apnea, arthritis, fatty liver, renal insufficiency, gallstones, morbid obesity, aortic valve replacement, pulmonary hypertension, CKD stage 3, anxiety, anemia",,"hydrocodone-acetaminophen (hallucinations), nitrofurantoin (unknown)","['Alanine aminotransferase normal', 'Aspartate aminotransferase normal', 'Blood bicarbonate decreased', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine increased', 'Blood glucose increased', 'Blood magnesium increased', 'Blood pH decreased', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea increased', 'Carbon dioxide decreased', 'Cardiac arrest', 'Chest X-ray abnormal', 'Continuous positive airway pressure', 'Death', 'Dyspnoea', 'Endotracheal intubation', 'Foaming at mouth', 'Haematocrit decreased', 'Haemoglobin decreased', 'Haemoptysis', 'PCO2 increased', 'PO2 decreased', 'Platelet count increased', 'Pneumothorax', 'Protein total normal', 'Pulmonary oedema', 'Respiratory distress', 'Unresponsive to stimuli', 'White blood cell count normal']",1,MODERNA,IM 1088842,CA,77.0,M,"The patient is a 77-year-old male with T2DM (not on medications), gout, and HTN who received the first dose of the Pfizer COVID-19 vaccine on 2/14. On 2/17 (three days after vaccination), he sought care in the emergency department for chest pain that worsened when he was supine and shortness of breath. EKG in the emergency room showed STEMI and troponin levels were normal. He was transferred to a different facility for cardiac catheterization. Cath showed mild circumflex disease and a stent was placed. He was diagnosed with pericarditis at that time (elevated inflammatory markers ESR/CRP). He was discharged home post cath on Plavix/ASA. He had an echocardiogram at his PCP?s office on 2/25, results still pending (as of 3/10). 2/25 ? televist with cardiologist who concurred with pericarditis, maybe mild coronary artery disease (follow-up scheduled 3/11). 3/3 chest pain symptom improved further, no cough, improved shortness of breath. Medications at home: statin, previously colchine for gout, likely BP medication (PCP will send records) Allergies: None known. Vaccine Indication: Age >75",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/14/2021,02/17/2021,3.0,PVT,,,"Type 2 diabetes (diet-controlled), hypertension",,None,"['Acute myocardial infarction', 'C-reactive protein increased', 'Catheterisation cardiac abnormal', 'Chest pain', 'Coronary arterial stent insertion', 'Coronary artery stenosis', 'Dyspnoea', 'Echocardiogram', 'Electrocardiogram abnormal', 'Pericarditis', 'Red blood cell sedimentation rate increased', 'Troponin normal']",1,PFIZER\BIONTECH,IM 1088881,UT,19.0,M,"19 yo medically complex M with prior COVID infection in Dec 2020 who received first dose of the Moderna COVID vaccine on 3/4 as well as Epo shot (for chronic anemia secondary to CKD). Recently admitted for MRSA sacral abscess and had recently been discharged to complete treatment on oral Bactrim. On 3/6, developed worsening diarrhea, decreased urine output, facial and tongue swelling, and altered mental status. EMS was called and patient was brought to the ED. Upon presentation, noted to have hypotension and was fluid resuscitated. Initial blood gas with hypercarbia, and he was intubated for airway protection. CXR was non-focal. He was started on empiric vancomycin and ceftriaxone, although these were discontinued with negative blood and urine cultures. Repeat respiratory film array was negative. Patient intubated 3/6-3/10.",Not Reported,,Yes,Yes,,Not Reported,Y,03/04/2021,03/06/2021,2.0,OTH,"acetaminophen 160 mg/5 mL oral suspension, 640 mg= 20 mL, Oral, every 4 hr, 3 refills, acetylcysteine (NAC) 10% inhalation solution, 0.6 g= 6 mL, Nebulized Inhalation, BID, 1 refills, albuterol 90 mcg/inh aerosol inhaler, 4 puffs, Inha","MRSA sacral soft tissue abscess > s/p surgical I&D 2/25 > MRI with contrast 2/25 without evidence of deeper osteomyelitis > s/p vancomycin 2/24-2/28, Bactrim 2/28-3/9 Recent treatment for aspiration pneumonia > Completed ABX on 1/29 Recent steroid exposure with h/o prior adrenal insufficiency, not currently on steroids","Lesch-Nyhan disease Chronic renal failure, stage IIIa > Nephrogenic diabetes insipidus secondary to uric acid nephropathy > History of nephrolithiasis, 3/9 retroperitoneal US negative for stones/new obstruction > Baseline Cr 1.7-1.8, eGFR of ~55-59 mL/min/1.73 meters squared, corresponding to stage 3 CKD) Chronic macrocytic anemia requiring transfusions (due to folate pathway interference in Lesch-Nyhan) Hx of multiple prior UGI bleeds: > s/p multiple scopes,, most recent 12/24 with c/f neutrophilic inflammation stomach/duodenum with inflammatory mass > mild chronic gastritis/ irritation from g-tube Chronic lung disease on baseline home oxygen Seizure disorder on multiple AEDs Dysphagia with GT dependence Hx of Methicillin resistant Staphylococcus aureus infection Hx of Recurrent infections: sinusitis, pneumonia (+/- aspiration)",,Adhesive bandages Intolerance (diarrhea only) with amoxicillin and clindamycin,"['Antibody test negative', 'Blood pH decreased', 'C-reactive protein increased', 'Chest X-ray normal', 'Clostridium test positive', 'Diarrhoea', 'Endotracheal intubation', 'Full blood count abnormal', 'Haemoglobin decreased', 'Hypercapnia', 'Hypotension', 'Mental status changes', 'PCO2 increased', 'PO2 increased', 'Platelet count normal', 'Swelling face', 'Urine output decreased', 'White blood cell count decreased']",1,MODERNA,IM 1088883,CA,48.0,F,"On 3/4/2021 developed fatigue, headache and back ache around 10am. By 2pm had developed chills and severe body aches. By 8pm, had also developed severe chills, sweating, body aches and fever of 100. by 3/5/2021 at 10am, all symptoms had resolved. on 3/6/21, I woke up with a pulse rate of 148 and hives on my arms. Went to Urgent care, where EKG showed no issues. on 3/6/21 at 12pm, I developed an adema on my chin which was hot, red, swollen and painful. At 5pm, my bottom lip began to swell and I returned to Urgent Care. Diagnosed with an Angioedema and provided steroids. My throat, face, eyes, lips and mouth swelled and it was difficult to talk and breath. The swelling continued off and on thru 3/9/21. On 3/9/21 I began to develop a sinus infection and phlemb began to cause me to cough.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/17/2021,03/04/2021,15.0,PUB,"Tramadol, Vitamin D3, Vitamin B-12, Potassium Gluconate, Amlodipine Besy-Benazepril, Lansoprazole",None,High Blood Pressure and Asthma,,Bee Venom,"['Angioedema', 'Back pain', 'Blood test normal', 'Chills', 'Dyspnoea', 'Electrocardiogram normal', 'Face oedema', 'Fatigue', 'Headache', 'Influenza A virus test negative', 'Influenza B virus test', 'Lip swelling', 'Mouth swelling', 'Pain', 'Pharyngeal swelling', 'Productive cough', 'Pyrexia', 'SARS-CoV-2 test negative', 'Sinusitis', 'Skin warm', 'Speech disorder', 'Swelling face', 'Urticaria']",2,MODERNA,IM 1088932,MN,72.0,F,"Patient received dose #2 of moderna vaccine on 3/2/2021. The next morning (3/3/21) she had a syncopal event with LOC for several minutes. She recovered and was not evaluated by physician until 3/9/21. On 3/10/21, she had a CTA of chest showing bilateral PEs.",Not Reported,,Yes,Not Reported,,Not Reported,,03/02/2021,03/03/2021,1.0,UNK,"Atorvastatin 20 mg daily, vitamin D 2000 IU daily, clobetasol 0.05% ointment, HCTZ 25 mg daily, latanoprost 0.005% eye drop 1 drop each evening, multivitamin, paroxetine 20 mg daily.",First Moderna vaccine was administered on 2/2/2021,"anxiety, HLD, CAD, HTN, prediabetes, lichen sclerosus",,None known,"['Chest X-ray', 'Computerised tomogram thorax', 'Fibrin D dimer', 'Full blood count abnormal', 'Loss of consciousness', 'Metabolic function test normal', 'Pulmonary embolism', 'Syncope']",2,MODERNA, 1088956,NY,74.0,M,Tested positive and had symptoms for Covid-19 . Admitted to hospital on 2/14/21 in the icu and died in 2/28/21,Yes,02/28/2021,Not Reported,Yes,15.0,Not Reported,N,02/03/2021,02/14/2021,11.0,PHM,No,No,Diabetes,,No,"['COVID-19', 'Death', 'Intensive care', 'SARS-CoV-2 test positive']",1,MODERNA,SYR 1088962,MN,72.0,M,"Patient presents to ED with left hand swelling, fever, and left arm pain on 3/10/21 after receiving his COVID 19 vaccine at Clinic on 3/4/21. I'm unable to determine the route of administration from the immunization documentation. Patient reports that the swelling significantly increased over the past day with increased swelling in his left hand and pain from his left clavicle to his left hand. Patient is febrile upon presentation with a documented temperature of 38.7 and sinus tachycardia. EKG is otherwise unremarkable. Patient has been diagnosed with left arm cellulitis and is being admitted to our hospital. He has been started on vancomycin 800 mg and Zosyn 3.375 g IV.",Not Reported,,Not Reported,Yes,,Not Reported,N,03/04/2021,03/09/2021,5.0,PVT,Amlodipine 5 mg daily,Patient tested positive for COVID-19 on 12/4/20 and was released from remote monitoring program via Clinic on 12/21/20. Patient received remdesivir 200 mg IV on 12/9 and 100 mg IV daily from 12/10/20 to 12/13/20.,"Hypertension, CKD, Alpha thalassemia minor, right above knee amputation",,NKA,"['Blood chloride increased', 'Blood culture', 'Blood lactic acid normal', 'Blood potassium decreased', 'Carbon dioxide decreased', 'Cellulitis', 'Electrocardiogram abnormal', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Sinus tachycardia', 'White blood cell count increased']",1,JANSSEN,UN 1088967,NM,75.0,F,"As her husband, and caregiver since 2017, when she was diagnosed with dementia (I believe she had symptoms long before that) I noticed a very observable increase in the severity of her symptoms of confusion, memory loss, not being able to stay focused, disorientation, anxiety, agitation, anger, depression as a direct result of the second dose of the covid vaccine The change was very noticeable and has not gotten any better. This appears to be a permanent escalation in the severity of her symptoms. I would say she has advanced a stage to stage 5. We are now considering adding a new drug for her to take to try and level things out. She also appeared to have a slight fever for 48 hours after.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/23/2021,02/25/2021,2.0,OTH,"Omeprazole, Donepezil, Lorazepam, Levothyroxin, Paroxetine, Vitamin D3, Acetominophen, Calcium Carbonate, Advair Diskus",None,"Stage 4 (now stage 5) vascular dementia, COPD, Low thyroid, hiatal hernia",,None,"['Agitation', 'Amnesia', 'Anger', 'Anxiety', 'Condition aggravated', 'Confusional state', 'Dementia', 'Depression', 'Disturbance in attention', 'Pyrexia']",2,MODERNA,IM 1088973,NM,22.0,F,22 year old G2P0 at the time of vaccination. Delivery by cesarean at 40w6d. Female infant with apgars 7 at one minute and 9 at 5 minutes. Weight 7-14. Baby developed seizures on day of life #2. She was found to have a large ischemic injury in her brain.,Not Reported,,Not Reported,Yes,,Not Reported,N,02/12/2021,03/01/2021,17.0,PVT,"prenatal vitamin, iron",none,none,,none,"['Caesarean section', 'Exposure during pregnancy', 'Inappropriate schedule of product administration']",1,PFIZER\BIONTECH,IM 1088982,KS,74.0,M,"Pt tested COVID positive on 2-5-21, Hospitalized on 2/18/21",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/03/2021,02/05/2021,2.0,PHM,,,,,,"['COVID-19', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 1088985,,93.0,F,"Severe thrombocytopenia, consideration of ITP",Not Reported,,Not Reported,Yes,,Not Reported,,03/03/2021,03/07/2021,4.0,UNK,,,,,,['Thrombocytopenia'],2,MODERNA, 1089038,IA,65.0,F,"Patient died 2 days after COVID vaccination, concern for vaccine related death. Autopsy showed bilateral pulmonary emboli. No evidence death was vaccine related.",Yes,01/29/2021,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/29/2021,2.0,OTH,,,,,,"['Autopsy', 'Death', 'Pulmonary embolism']",UNK,MODERNA, 1089041,PA,47.0,F,"Throat scratchy, dry heaving, throat closed, needed epi pen, went to Er, had second episode, overnight in hospital with body aches, headache, had third episode in the morning 24 hrs after injection",Not Reported,,Yes,Yes,2.0,Not Reported,U,03/09/2021,03/09/2021,0.0,PVT,Vegan multivitamin,None,Anemia,,"Penicillin, sulfa, most antibiotics.","['Headache', 'Pain', 'Retching', 'Throat irritation', 'Throat tightness']",1,PFIZER\BIONTECH,SYR 1089051,CA,24.0,M,Patient was given dose one of Moderna vaccine this morning. Patient returned to our site around 1230 pm with ?facial swelling.? He also reported throat itching and tightness.,Not Reported,,Yes,Not Reported,,Not Reported,U,03/10/2021,03/10/2021,0.0,PUB,Unknown,No,No,,Pork,"['Anaphylactic reaction', 'Swelling face', 'Throat irritation', 'Throat tightness']",1,MODERNA,IM 1089057,CA,90.0,M,"Acute Pulmonary Embolism, and Acute Deep Vein Thrombosis. He is active every day doing arm exercises and walking in place for exercise, and moving about his house with his walker, and this day was no different. He finished making breakfast and went to sit down on the couch, and had sudden-onset pleuritic chest pain. No other recent risks such as long car ride, illness, plane ride, or other immobility. Patient says the vaccine was Moderna second dose, given at pharmacy.",Not Reported,,Yes,Yes,,Not Reported,N,03/03/2021,03/05/2021,2.0,PHM,"simvastatin, clopidogrel",,"CAD/stent, hypertension, hyperlipidemia",,"amoxicillin, cephalexin, ciprofloxacin, clindamycin, sulfa","['Computerised tomogram thorax', 'Deep vein thrombosis', 'Full blood count normal', 'Metabolic function test normal', 'Pleuritic pain', 'Pulmonary embolism', 'SARS-CoV-2 test negative', 'Ultrasound Doppler', 'Walking aid user']",UNK,MODERNA, 1089073,CA,43.0,F,Headache fever nucchal rigidity. Muscle aches,Not Reported,,Yes,Yes,5.0,Not Reported,Y,02/10/2021,02/25/2021,15.0,OTH,None,None,None,,None,"['Computerised tomogram', 'Culture', 'Headache', 'Laboratory test', 'Lumbar puncture', 'Myalgia', 'Nuchal rigidity', 'Pyrexia']",2,MODERNA,IM 1089091,,64.0,M,"Patient received 1st COVID vaccine on 2.12.21. Reported to local ER with chest pain and increased ShOB on 2.22.21. Found to be positive for COVID, elevated troponin. Transferred to medical center. Patient was mildly hypoxic on the floor but never required more than 2L nasal prongs. Patient is currently on dialysis. Patient received dexamethasone therapy only while on the floor. Discharged home on 3.4.2021.",Not Reported,,Not Reported,Yes,10.0,Not Reported,Y,02/12/2021,02/22/2021,10.0,PVT,,,,,,"['COVID-19', 'Chest pain', 'Dialysis', 'Dyspnoea', 'Hypoxia', 'SARS-CoV-2 test positive', 'Troponin increased']",1,MODERNA,IM 1089100,NC,36.0,M,Woke up on Friday morning (3/5) with severe neck pain and vertigo. Tried to walk to bathroom and was falling over to the right side and felt very nauseous. Starting throwing up. Arrived at ER around9:30AM and was diagnosed with vertigo and discharged a few hours later. He slept most of the day but woke up for a few minutes to take medicine on Friday evening and told me his vision was blurry. He went back to sleep and slept until Saturday (3/6) morning around 9:30. He told me his vision was still really blurry so we went back to the ER. They did an MRI and MRA and saw that he had two strokes. The strokes have affected his vision and he still has blurry vision and is not able to see well peripherally.,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,03/02/2021,03/05/2021,3.0,PHM,None.,None.,None.,,None.,"['Balance disorder', 'Magnetic resonance imaging head abnormal', 'Nausea', 'Neck pain', 'Vertigo', 'Vision blurred', 'Visual field defect', 'Vomiting']",1,MODERNA, 1089123,ME,23.0,F,"On 01-13-2021 I developed pain at the bottom of my left lung. I was painful to breathe. I saw my PCP on 01-19-2021. I also went to the hospital where they performed chest x-ray, blood work, urine test and an ultrasound of the chest. I did not stay any days at the hospital. My exams were negative.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/08/2021,01/12/2021,4.0,PVT,Upropien medication,,low intensity asthma,,,"['Blood test normal', 'Chest X-ray normal', 'Painful respiration', 'Pulmonary pain', 'Ultrasound chest', 'Urine analysis normal']",1,MODERNA,IM 1089129,CA,86.0,M,Patient's PLT 17. Pt. taken to the ER and diagnosed with ITP,Not Reported,,Yes,Yes,3.0,Not Reported,U,02/01/2021,02/23/2021,22.0,PVT,"Furosemide, amlodipine, metoprolol, potassium chloride, simvastatin,aspirin, omeprazole, cetirizine, fluticason propionate","HTN, GERD, Compensated cardiac failure, hyperlipidemia, PAT",,,None,"['Full blood count', 'Immune thrombocytopenia', 'Platelet count decreased']",2,MODERNA, 1089147,SC,56.0,F,"Room spinning unable to stand up; when attempting to stand vomitting uncontrollably; lasted 2-days; unable to walk or stand; crawled to make it to the bathroom; - Started Saturday evening, February 6 - Monday, February 8 when I went to urgent care",Not Reported,,Not Reported,Not Reported,,Yes,N,02/01/2021,02/06/2021,5.0,PVT,,,,,,"['Alanine aminotransferase normal', 'Albumin globulin ratio normal', 'Antiacetylcholine receptor antibody', 'Aspartate aminotransferase normal', 'Blood albumin normal', 'Blood alkaline phosphatase normal', 'Blood bilirubin normal', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine normal', 'Blood glucose normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea normal', 'Carbon dioxide normal', 'Dizziness postural', 'Dysstasia', 'Gait inability', 'Globulin', 'Glomerular filtration rate normal', 'Haematocrit normal', 'Haemoglobin normal', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Mean platelet volume normal', 'Platelet count normal', 'Protein total normal', 'Red blood cell count normal', 'Red cell distribution width normal', 'Vertigo', 'Vomiting', 'White blood cell count normal']",1,PFIZER\BIONTECH,SYR 1089200,FL,46.0,F,"The first she had numbness in arm with the injection, hives and tingling in face. Sunday, everything went back to normal. Monday around 3:00 or 3:30, face was hot and had hives. She went to the ER. Was told she had a mild rash, and gave Benadryl and ordered EpiPen for emergency. Left ER to pick up prescription but tongue began to swell, went back to ER, gave you Cortisone 50 mg and Pepcid Benadryl IV for 7 days. Yesterday, had another face reaction, had hives very mild only in the morning. Today at 8:00a.m., had redness in face. Around 3:00pm, lips and tongue were swollen and has extremely dry mouth. Today, she is on her way to the ER because her tongue has swollen again.",Not Reported,,Not Reported,Yes,,Not Reported,N,03/06/2021,03/06/2021,0.0,OTH,"Advair, Albuterol",no,Asthma,,no,"['Blood test', 'Dry mouth', 'Erythema', 'Hot flush', 'Hypoaesthesia', 'Lip swelling', 'Paraesthesia', 'Rash', 'Swollen tongue', 'Urticaria']",1,PFIZER\BIONTECH,IM 1089214,FL,46.0,M,"After 1st dose abrupt onset of severe vertigo very brief followed by dizziness and nausea for 48 hours. After 2nd dose with about same time frame repeat onset of severe vertigo, again brief, followed by dizziness and nausea. This time it has not gone away although improved!",Not Reported,,Not Reported,Not Reported,,Yes,N,12/23/2020,01/07/2021,15.0,PVT,None,None,None,,None,"['Dizziness', 'Full blood count normal', 'Magnetic resonance imaging head normal', 'Magnetic resonance imaging neck', 'Metabolic function test normal', 'Nausea', 'Vertigo']",2,MODERNA,IM 1089215,CA,78.0,M,Syncopal episode followed by death. Unable to be revived. Coroner's case.,Yes,03/02/2021,Not Reported,Not Reported,,Not Reported,,03/02/2021,03/02/2021,0.0,PVT,Spiriva,"COPD, hypotension, syncope","COPD, hypotension, syncope",,unknown,"['Death', 'Syncope']",2,MODERNA,IM 1089227,OK,50.0,F,"I received injection at 1332 in L arm. Within 5 minutes I began to feel tingling in the left side of my neck and the tip of my tongue was numb. I waited about 5 min to see if sx would diminish and notified clinic staff at 1344. Physician and nurse immediately responded to assess. At 1350 I looked in mirror and neck was red from L side of neck to center. As physician was again assessing symptoms we both watched the redness spread to the right side of my neck. By this time my lips were also numb and I began feeling mild full body tingling. Physician and I entered clinic and I received epi-pen injection at 1404. The redness in neck resolved within a few minutes and the total body tingling also resolved. Nurse noted mild swelling around upper lip but it also quickly resolved after receiving epi-pen injection. EMS were called. I was evaluated by EMS and deemed stable. I had 2 epi-pens in my possession as well as Vistaril and an inhaler so I declined being treated at emergency room I left clinic at 1430. On my drive home, I noted that area above upper lip and nose were numb. I also began experiencing numbness of soft palate of roof of mouth. I arrived home shortly before 1500 and took a Pepcid and a dose of Vistaril. I reported reaction to the health department and Moderna on 3/9/21. I was evaluated by my personal physician on 3/9/21. I continue to have numbness on tip of tongue and lips 3/10./21. Per Moderna personnel, they were unable to tell me how long to expect symptoms to last and I continue to treat with antihistamines and monitor.",Not Reported,,Yes,Not Reported,,Not Reported,N,03/08/2021,03/08/2021,0.0,PVT,"atenolol (migraine prevention), Advair inhaler, levothyroxine, Zyrtec, vit D, multivitamin",seasonal allergies,"asthma, hypothyroid",,Bee stings adhesives,"['Erythema', 'Hypoaesthesia oral', 'Intranasal hypoaesthesia', 'Lip swelling', 'Paraesthesia']",1,MODERNA,IM 1089242,MN,71.0,F,"After COVID vaccine #2- headache started same evening around 5 pm, tiredness, painful charlie horses. 2nd night- chills, tiredness, sore legs, difficulty walking. 3/7/21- woke up with painful legs, heaviness, unable to walk, continued mild headache. treatment include: Tylenol, Gabapentin and lidocaine cream, avoiding narcotics rehab therapies",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,03/05/2021,03/05/2021,0.0,PUB,Levothyroxine Mag Citrate Melatonin escitalopram aspirin BOSWELLIA SERRATA fluticasone propionate azelastine nasal solution omega-3 fatty acids Calcium,"headache/ congestion about a month prior- COVID-19 not detected, tested X2 - on 2/3/21 and 2/15/21 received COVID-19 vaccine #1 on 2/12/21- headache","history of hypothyroidism, hyperlipidemia, irritable bowel syndrome",,Eggs or egg derived products Fluoxetine Morphine Augmentin,"['Asthenia', 'Chills', 'Discomfort', 'Fatigue', 'Gait disturbance', 'Gait inability', 'Headache', 'Magnetic resonance imaging spinal normal', 'Muscle spasms', 'Myelitis', 'Pain', 'Pain in extremity', 'Paraesthesia']",2,PFIZER\BIONTECH,IM 1089259,IN,58.0,F,"After my Johnson & Johnson vaccine, the following day I developed a red, diffuse in radius size (like a spider bite) rash that is warm to touch and very painful. I am still in pain, the site has some color to it and will be having an appointment with my PCP on 03-11-2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/07/2021,1.0,OTH,,,,Flu shot,"Penicillin (since was an infant, had reaction)","['Injection site discolouration', 'Rash', 'Rash erythematous', 'Skin warm']",1,JANSSEN,IM 1089268,TN,76.0,F,"Developed N/V ~2 weeks after 2nd covid vaccine. Presented to PCP, labwork revealed AKI and hyperkalemia. Sent to ED. Admission lab included SCr 8.55 mg/dL and K+ 5.7 mmol/L. Repeat K+ level 7.0 mmol/L (6 hours later). Pt admitted, vascath placed, emergently dialyzed. Further work up revealed positive anti-nuclear antibody, positive anti-nuclear antibody titer, and elevated glomerular basement membrane antibody. High dose steroids (methylprednisone 1g iv qday x 3 days) started for presumed vasculitis. Renal biopsy performed, results c/w severe crescentic acute glomerulonephritis. Treated with rituximab 375mg/m2, subsequently transferred to another facility for plamapheresis.",Not Reported,,Yes,Yes,7.0,Not Reported,U,02/13/2021,02/25/2021,12.0,OTH,"simvastatin, losartan, metformin, aspirin, hydrochlorothiazide, cholecalciferol, multivitamin c Fe",none,"hypertension, hyperlipidemia, diabetes, anemia",,NKDA,"['Acute kidney injury', 'Anti-glomerular basement membrane antibody positive', 'Antineutrophil cytoplasmic antibody', 'Antinuclear antibody positive', 'Biopsy kidney abnormal', 'Blood creatinine increased', 'Blood immunoglobulin A', 'Blood immunoglobulin G normal', 'Blood immunoglobulin M', 'Blood potassium increased', 'Blood urea increased', 'C-reactive protein increased', 'Complement factor C3', 'Complement factor C4', 'Dialysis', 'Glomerulonephritis acute', 'Hyperkalaemia', 'Immunoglobulins normal', 'Nausea', 'Vascular catheterisation', 'Vasculitis', 'Vomiting']",2,PFIZER\BIONTECH,IM 1089332,AR,67.0,M,"3 hours later dizzy, sweating profusely, nausea blood pressure 199/110",Not Reported,,Yes,Not Reported,,Not Reported,N,03/10/2021,03/10/2021,0.0,OTH,"Triamaterine, omeprazole",Hernia,High blood pressure,,,"['Dizziness', 'Hyperhidrosis', 'Nausea']",1,MODERNA,SYR 1089343,KY,28.0,F,"After my vaccine I immediately experienced fever, body aches, chills, was dehydrated have a paralyzed vocal cord. I went to the hospital since I am pregnant to check on my baby and myself. I have not fully recovered from my vocal cord. At the hospital a rapid Covid test was performed along with a flu swab and lab work.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/20/2021,01/20/2021,0.0,PHM,Pre-natal vitamins,,,,,"['Chills', 'Dehydration', 'Exposure during pregnancy', 'Immediate post-injection reaction', 'Influenza virus test', 'Laboratory test', 'Pain', 'Pyrexia', 'SARS-CoV-2 test', 'Vocal cord paralysis']",2,PFIZER\BIONTECH,IM 1089349,TX,63.0,F,"Patient had an adverse reaction to her first shot, unreported, mostly local to the injection. For this 2nd dose, she was not feeling well the day after the shot, but was at work. She did not show up for work on Friday and was found dead. Time of death was undetermined. She lived alone. An autopsy was not performed.",Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,02/24/2021,02/25/2021,1.0,PUB,,,,,,"['Death', 'Malaise']",2,MODERNA,SYR 1089382,CA,59.0,M,"2/17/21 - Moderna vaccination taken at approximately 4:45pm 2/23/21 - Approximately 3:30 pm right ear is stuffed, ear and nasal passages feel pressure, 5:00 pm right hear has lost hearing, 10:00pm experiencing severe vertigo, 10:30 admitted to Emergency Department, 11:30pm CT Scan taken, prescribed Meclazine 25mg tab and Lorazepam 0.5mg tab, 5:00 am released with instructions to see family physician and ENT 2/25/21 appointment with family physician, prescribed Amoxicillin-clav 875-125mg 3/5/21 appointment with Dr., ENT , informed of profound hearing loss in right ear, prescribed Prednisone 10mg tab 3/9/21 appointment with Dr., ENT, confirms total hearing loss of right ear 3/11/21 pending appointment for an MRI 3/12/21 pending appointment for 2nd audiology test",Not Reported,,Not Reported,Not Reported,,Yes,N,02/17/2021,02/23/2021,6.0,OTH,Hydrochlorothiazide 25 mg tab Losartan Potassium 100 Mg tab Potassium CL ER 20 MEQ tab Atorvastatin 20 mg tab Montelukast SOD 10mg tab,None,Asthma Hyper-tension,,None,"['Audiogram abnormal', 'Computerised tomogram', 'Deafness unilateral', 'Ear discomfort', 'Laboratory test', 'Magnetic resonance imaging', 'Nasal discomfort', 'Vertigo']",1,MODERNA,SYR 1089404,WA,35.0,F,About six minutes after vaccination I started to fell flush and tingly. Elevated heart rate which lasted for 23 hours. After second vaccination elevated heart rate for a few hours and flu like symptoms. Remained in observation for 45 minutes to make sure. Morning sickness which may be related to early pregnancy.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,03/12/2021,59.0,PVT,Plaquenil,,Sjogrens-immune disorder,,Pediazole Cecor,"['Exposure during pregnancy', 'Flushing', 'Heart rate increased', 'Influenza like illness', 'Morning sickness', 'Paraesthesia']",1,MODERNA,IM 1089419,OK,60.0,M,"Received COVID-19 Vaccine on 03/08/2021. About 7:00 am the next morning began having N/V x4 past 12 hrs, diarrhea x 6, headache and blood in urine. Chronic illness of stage 4 kidney disease with bilateral nephrostomy and acute bloody discharge, ulcerative colitis with colostomy and acute high output, CAD with 7 cardiac stents and 2 CABG. A&Ox4, Malaise, tachycardia and hypotension, afebrile. Patient reports chronic abdominal pain unchanged today. Denies back pain, chest pain, cough, or SHOB. Afebrile. Patient has new diagnosis of UTI. IV fluids administered, IV Zofran, Meropenem, and po Hydrocodone/APAP. Transferred due to creatinine of 4.3, bloody urine, and UTI. T: 98.1 HR 91, R-14 BP 106/71, O2 sat 97%",Not Reported,,Not Reported,Yes,,Not Reported,,03/08/2021,03/09/2021,1.0,PVT,"Zanaflex, Percocet, Xanax, Brilinta, Insulin",,"Stage 4 kidney disease, nephrostomy, ulcerative colitis with colostomy, CAD with 2 CABG & 7 cardiac stents,",,"Influenza Vaccine, Pneumonia vaccine, Ambien, Lisinopril, PCNs","['Blood creatinine increased', 'Blood culture', 'Blood urine present', 'Bloody discharge', 'Brain natriuretic peptide', 'Culture urine', 'Diarrhoea', 'Full blood count', 'Headache', 'Hypotension', 'Malaise', 'Metabolic function test abnormal', 'Nausea', 'Tachycardia', 'Urinary tract infection', 'Urine analysis abnormal', 'Vomiting']",,JANSSEN,IM 1089441,FL,76.0,F,"Sunday, Feb 21, 2021. Patient told her husband she didn?t feel well and she lay down next to him. She was tossing and looked like she was trying to get up. He was talking to her and she wasn?t answering him. She was having trouble breathing. Took her to the hospital right away at 7:30 pm. They put her into a comma with a respirator. Finally went from emergency room to ICU on Monday. Then on Wednesday they took the respirator out and I spoke to her ? told her we all love her and she could only say hoarsely ?terrible, terrible.? They said she might get moved to regular floor. But then Wednesday night couldn?t breathe again and put the respirator back in. Thursday morning husband had it removed and she died that evening at 10:51 on February 25.",Yes,02/25/2021,Not Reported,Yes,4.0,Not Reported,N,02/01/2021,02/21/2021,20.0,OTH,Blood pressure.,,Still a smoker when she died but they x-rayed her and did not see any cancer.,,,"['Death', 'Dysphonia', 'Dyspnoea', 'Intensive care', 'Malaise', 'Mechanical ventilation', 'Medical induction of coma', 'Restlessness', 'Unresponsive to stimuli']",1,MODERNA, 1089444,WA,57.0,M,"Miller Fisher syndrome, an acute inflammatory demyelinating polyneuropathy (GBS) variant. Acute onset of transient diplopia, and persistent dysarthria, ataxia, and areflexia starting approximately 1 week after vaccination. Patient was treated with IVIG, with good improvement in symptoms, allowing discharge home.",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,02/23/2021,03/01/2021,6.0,PVT,Losartan 100 mg daily HCTZ 12.5 mg daily,None,HTN HLD Prediabetes Migraines,,,"['Anti-ganglioside antibody', 'Anti-ganglioside antibody negative', 'Areflexia', 'Ataxia', 'Diplopia', 'Dysarthria', 'Guillain-Barre syndrome', 'Immunoglobulin therapy', 'Laboratory test normal', 'Magnetic resonance imaging head', 'Magnetic resonance imaging neck', 'Miller Fisher syndrome', 'Subacute inflammatory demyelinating polyneuropathy']",1,PFIZER\BIONTECH,IM 1089507,MD,64.0,F,"48 hours (Feb 26) after receiving the shot, I had anaphylaxis symptoms... red blotches around mouth, swelling face, swelling lips, ants-crawling feeling on face, neck and scalp. Went to Urgent Care, given benadryl and steroid shot. Rx Prednisone 20 mg x2, 5 days. Anaphylaxis happened again the next day (Feb 27) just prior to taking the first prednisone. Went back to Urgent Care, another shot. Meds kept full on allergic reactions at bay on Monday and Tuesday. Had swelling face, lips and tongue happen in Primary Care office on March 3, received another shot and increased prednisone rx to 30 mg x2, with taper. On March 5, happened again, went to ER, where doc changed timing of prednisone to 60 mg all in one dose. All in conjunction with hydroxyzine 25 mg every 12 hours and 50 mg of benadryl every six hours. Situation continues with mild swelling, itchy sensations happening just before it is time to take new meds .",Not Reported,,Yes,Not Reported,,Not Reported,N,02/24/2021,02/26/2021,2.0,PHM,"Hydroxyzine 50 mg, levothyroxine 100 mcg, Vit D 5000, multivitamin, Magnesium 400 mg,",,"inflammation issues, especially following knee replacement surgery in July 2019.",,"No known allergies, history of random anaphylactic shock.","['Anaphylactic reaction', 'Formication', 'Hypersensitivity', 'Lip swelling', 'Lymphocyte count increased', 'Monocyte count increased', 'Pruritus', 'Rash macular', 'Swelling face', 'Swollen tongue', 'White blood cell count increased']",UNK,PFIZER\BIONTECH,SYR 1089536,WI,80.0,M,Moderna COVID-19 Vaccine EUA Heart attack Death,Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/15/2021,3.0,PHM,"Aspirin, CoQ10, fish oil, hydrochlorothiazide, lovastatin, multivitamin, saw palmetto, vitamin d3",,,,,"['Death', 'Myocardial infarction']",1,MODERNA,SYR 1089592,IL,75.0,F,"Tested positive for Covid-19 Headache, fever, body chills and aches, loss of smell and taste, nausea, loss of appetite, cough was initial symptom with above following on January 24. Test was positive on January 28. Diagnosed with covid pnemonia on first hospitalization on FEb 5, 2021. Develeped full body active tremors and stutter Feb. 8 re-admitted to ER Feb. 10. GI pain and nausea persisted along with debilitating tremors and stutter. Re-admitted to hospital Feb, 22 for 4 days and transferred to Rehab Clinic for 13 days. Tremors and Gi issues still present as of Feb. 10, 2021",Not Reported,,Yes,Yes,,Yes,N,01/22/2021,01/24/2021,2.0,OTH,"Eliquis,Rosuvastatin,Fenofibrate,Pepcid,Metopropol,Prempro",None,Heart disease,,"All in opdiod family, Shell Fish Allergy, Latex Allergy","['Ageusia', 'Anosmia', 'COVID-19', 'COVID-19 pneumonia', 'Chills', 'Computerised tomogram head', 'Computerised tomogram neck', 'Computerised tomogram thorax', 'Cough', 'Decreased appetite', 'Dysphemia', 'Electrocardiogram', 'Gastrointestinal pain', 'Headache', 'Magnetic resonance imaging head', 'Magnetic resonance imaging neck', 'Nausea', 'Pain', 'Pyrexia', 'SARS-CoV-2 test positive', 'Tremor']",1,PFIZER\BIONTECH,SYR 1089615,CA,85.0,M,The patient had possible syncopal episode and an increased white blood count with lactic acidosis on admission. He is currently still in hospital and had delirium and acute hypercapnic respiratory failure requiring BiPAP ventilatory support.,Not Reported,,Yes,Yes,2.0,Not Reported,N,02/26/2021,03/08/2021,10.0,PVT,"Aspirin, gabapentin, metformin, metoprolol, meloxicam, simvastatin, Lisinopril, glipizide",none,"coronary artery disease, type 2 diabetes, hypertension, history of non ST elevation myocardial infarction",,none,"['Alanine aminotransferase', 'Aspartate aminotransferase', 'Bilevel positive airway pressure', 'Blood bilirubin', 'Blood creatine phosphokinase', 'Blood creatinine', 'Blood gases', 'Blood lactic acid', 'Blood magnesium', 'Blood phosphorus', 'Blood urea', 'Brain natriuretic peptide', 'Chest X-ray', 'Computerised tomogram head', 'Computerised tomogram spine', 'Delirium', 'Echocardiogram', 'Full blood count', 'Lactic acidosis', 'Respiratory failure', 'Troponin', 'White blood cell count increased']",UNK,PFIZER\BIONTECH,IM 1089675,CO,50.0,F,"Anaphylaxis - rash, SOB, lip swelling. Body aches. Symptoms started within 1 hr of getting vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,N,03/10/2021,03/10/2021,0.0,PVT,,,"Hypertension, Constipation",,"Contrast Dye, Iodine, Lisinopril","['Anaphylactic reaction', 'Dyspnoea', 'Lip swelling', 'Pain', 'Rash']",UNK,MODERNA,IM 1089759,TN,86.0,M,Death,Yes,03/01/2021,Not Reported,Yes,6.0,Not Reported,N,02/01/2021,02/12/2021,11.0,PUB,,,Congestive heart failure,,None,['Death'],1,MODERNA, 1090298,NC,66.0,F,Tingling Pins and needles Burning sensation Pain,Not Reported,,Not Reported,Yes,2.0,Yes,N,01/31/2021,02/02/2021,2.0,UNK,Tenormin 12.5 mg Losartan 100mg Hctz 12.5 mg Lipitor 10 mg Prilosec 20 mg Aspirin 81 mg Vitamin D 4000 mg Zinc 50 mg,"Sinus surgery Jan 24, 2021",High blood pressure Tachycardia Reflux Diabetes High cholesterol,,None,"['Blood test', 'Burning sensation', 'Computerised tomogram head', 'Electrocardiogram', 'Magnetic resonance imaging head', 'Magnetic resonance imaging neck', 'Magnetic resonance imaging spinal', 'Pain', 'Paraesthesia']",1,MODERNA,IM 1090174,MT,,F,"Does not feel good; Face is cold; Headache; Muscles hurt; Got confused, lost/disorientation; Left side of face and body went numb; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of got confused, lost, disoriented, left side of body went numb, left side of face was still numb, does not feel good, headache, muscles hurt, face is numb and cold. The patient's medical history was not provided. No concomitant medications were reported. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown). On 29 Dec 2021, the same day following vaccination, the patient experienced events, got confused, lost, disoriented, and left side of body went numb. She was taken to the emergency room (ER) and observed for a potential stroke. The reporter stated, all labs came out fine and she was discharged the same day. On 30 Dec 2020, the patient experienced events, left side of face was still numb, does not feel good, headache, muscles hurt, and face is numb and cold. The treatment information reported included diphenhydramine. The action taken with mRNA-1273 in response to the events was unknown. The outcome for the events, got confused, lost, disoriented, was considered as unknown. The outcome for the events, left side of body went numb, left side of face was still numb, does not feel good, headache, muscles hurt, and face is numb and cold, was considered as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,12/29/2020,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Confusional state', 'Feeling abnormal', 'Feeling cold', 'Headache', 'Hypoaesthesia', 'Myalgia']",1,MODERNA,OT 1090175,TX,42.0,F,"Patient taken to the ER; Palpitation; Light headedness; Tingling sensation on hand and feet; Rash; Nausea; Fever (low grade); Chills; Server allergic reaction; A spontaneous report was received from a 43 years old female patient concerning her self who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea, palpitation, light headedness, rash, tingling sensation on hand and feet, fever (low grade), chills, was taken to the ER. The patient's medical history was not provided. No relevant concomitant medications were reported. On 19 Jan 2021, at around 3:50 pm, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly at unknown anatomical region for prophylaxis of COVID-19 infection. On 19 Jan 2021, about 7-10min after receiving the first dose of mRNA-1273, the patient experienced had palpitation light headedness and nausea. The patient was evaluated at vaccination post asked to go home. At home, the Palpitation continue (HR=150b/m in) and had rash and tingling on her hand and feet. The patient was taken to the ER at around 8:30-9:00 pm. At ER the patient was given IV fluids, Ibuprofen and acetaminophen. EKG was done and was normal, the patient was released to go home with a HR of 105 b/min. Since then she had repeated episodes of palpitation, fever (low grade) and chills. On 26 Jan-2021, the patient experienced the servere allergic reaction a week later after receiving the Moderna Covid-19. The Patient consented to be followed up by the safety department. Patient had been advice by her physician not to take the 2nd dose of the vaccine on 28 Jan 21. Treatment details included IV fluids, Acetaminophen, Ibuprofen Action taken with mRNA-1273 in response to the events was not reported. On an unknown date the outcome of events include nausea, light headedness, rash, tingling sensation on hand and feet was unknown and Palpitation, fever (low grade) and chill was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Allergy to vaccine', 'Chills', 'Dizziness', 'Electrocardiogram', 'Emergency care', 'Heart rate', 'Nausea', 'Palpitations', 'Paraesthesia', 'Pyrexia', 'Rash']",1,MODERNA,OT 1090176,TX,70.0,M,"Acid reflex symptoms; Felt his chest and stomach were burning; Felt his chest and stomach were burning; He had pain in his arm; Nauseas; A spontaneous report was received from an consumer concerning a 70 years old, male patient who experienced acid reflex symptoms, stomach burning, chest burning, nausea and pain in arm. The patient's medical history included chronic obstructive pulmonary disease, high blood pressure and anomality on his heart frequency all since an unknown date. The concomitant products included blood thinner medicine, Blood pressure medication, nasal spray, salbuterol and omeprazole. On 29 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 004M20A) for prophylaxis of COVID-19 infection. On 24 Feb 2021 patient experienced this acid reflect symptoms but worst than ever, he felt his chest and stomach were burning, nauseas and had pain in his arm. The patient was admitted to emergency room on 24 Feb 2021 due to acid reflect symptoms and was hospitalized on 24 Feb 2021. Laboratory investigations included tests (not specified) which revealed acid reflex. Treatment for the event included pill and had a via on his hand for an unknown indication. Action taken with mRNA-1273 in response to the events was not provided. The outcome of events acid reflex symptoms, he felt his chest and stomach were burning, nauseas and had pain in his arm were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: MOD-2021-026319:same reporter, different patient and event",Not Reported,,Not Reported,Yes,,Not Reported,U,01/29/2021,02/24/2021,26.0,UNK,NASAL SPRAY II; SALBUTEROL; OMEPRAZOLE,Blood pressure high,Medical History/Concurrent Conditions: Cardiac disorder NOS; COPD,,,"['Chest pain', 'Dyspepsia', 'Gastrooesophageal reflux disease', 'Nausea', 'Pain in extremity']",1,MODERNA,OT 1090177,IA,36.0,F,"Swollen face; Swollen lips; Very itchy eyes; Hives on the back; A spontaneous report was received from a nurse concerning a 36 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen face, swollen lips, very itchy eyes and hives on the back(Intervention/Medically Important). The patient's medical history included cataract surgery, bilateral eye surgery and COVID. The patient had giant tear left and buckles in bilateral eyes. Concomitant medications included seroquel (200mg), zoloft 50mg (50 mg), Topamax (100mg bid), Latuda (80mg), birth control, tylenol, advil and tizanidine (as needed) drugs used for unknown indication. On 26 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient experienced swollen face, swollen lips, very itchy eyes and hives on the back. Lab test was performed on 26 Jan 2021, tryptase level was 8.4. Treatment for the events include Epipen for both legs, pepcid and Benadryl. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, swollen face, swollen lips, very itchy eyes and hives on the back, were considered resolved on 27 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,01/26/2021,0.0,UNK,SEROQUEL; ZOLOFT; TOPAMAX; LATUDA; CONTRACEPTIVES (Birth control); TYLENOL; ADVIL 12 HOUR; TIZANIDINE,,Medical History/Concurrent Conditions: Cataract bilateral NOS (Patient medical history reported as bilateral eye surgery.); Cataract operation (Patient medical history reported as cataract surgery.); COVID-19 (Patient medical history reported as COVID from 03-SEP-2020 to 16-SEP-2020),,,"['Eye pruritus', 'Lip swelling', 'Swelling face', 'Tryptase', 'Urticaria']",1,MODERNA,OT 1090178,MI,48.0,F,"Overwhelming weakness; Blood pressure was elevated to 160/100 bpm; Brain fog; Thought was going to pass out, thought she was going to die; Pre-syncope episode; Systolic blood pressure of 180; Rigors in her chest; Neuro effects; A spontaneous report was received from a nurse who was also a 48-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced brain fog, pre-syncope episode, systolic blood pressure of 180, rigors in her chest, neuro effects, blood pressure was elevated to 160/100 bpm, overwhelming weakness and thought was going to pass out, thought she was going to die. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 31 Dec 2021, approximately 9 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. The patient had some brain fog off and on after receiving vaccine. About the 8th day on 08 Jan 2021, had a pre-syncope episode with systolic blood pressure of 180, thought patient was going to pass out and had rigors in patient's chest. Patient's husband called emergency medical service and went to the hospital where patient works, patient was evaluated in emergency room. The next day, patient rested at home. The following day, on 10 Jan 2021, patient went to work but couldn't think due to brain fog and neuro effects. After work, went back down to the emergency. Patient was admitted to the hospital and kept overnight. Consulted the neurologist. Neurologist stated it sounded like it was side effects from the immune response to the vaccine. Discharged the 11 Jan 2021 with no treatment besides follow-up with primary care doctor. Patient followed up with patient's primary care (cannot remember what date). The patient reported experiencing more pre-syncope episodes at home and at work. Patient's blood pressure was elevated to 160/100 bpm. Most recently had a syncope episode on 21 Jan 2021 where patient reported overwhelming weakness and had to sit down because patient ""thought patient was going to die"". After, made an appointment with the cardiologist. Had more test done. After taking medications patient felt a little bit better but had in head where doesn't feel right, feels little pings in head. Patient stated that patient missed forty hours of work because didn't feel so could work. Relevant laboratory tests included computed tomography scan of chest and brain, an Magnetic resonance imaging of the brain was performed results unspecified. Did bloodwork which showed her vitamin D level was low. Treatment for the event included fluids unspecified, vitamin D supplement for vitamin d deficiency, Toprol 25mg once a day to stop the pre-syncope episode and lisinopril 5mg once a day for blood pressure Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/31/2020,01/08/2021,8.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Asthenia', 'Blood pressure systolic', 'Chills', 'Feeling abnormal', 'Hypertension', 'Loss of consciousness', 'Neurological symptom', 'Presyncope', 'Vitamin D']",1,MODERNA,OT 1090179,,,F,"Faintness to the point of dropping to floor on her knees; Dizziness; A spontaneous report was received from a Healthcare Professional concerning a female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced events faintness to the point of dropping to floor on her knees and dizziness. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection. On an unknown date in Jan 2021, the patient experienced the events faintness to the point of dropping to floor on her knees and dizziness. The event faintness to the point of dropping to floor on her knees was considered serious with criteria of important medical event and dizziness was considered to be non-serious. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The events faintness to the point of dropping to floor on her knees and dizziness were considered recovered/resolved on an unknown date in Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/01/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Dizziness', 'Syncope']",1,MODERNA, 1090180,NC,36.0,F,"Vomited; a rash in her vagina area; Vaginal itching; she scratched so much that got abrasions; Chest was red; heart rate was elevated; Eyes were swollen; She scratched so much that she got abrasions; Felt like she was having an anxiety attack; Her arms and legs were itchy/body overall was itchy; Chest felt tight; Allergic reaction; Swelling of her throat; Dose was administered on day 57; Nausea; Strong headache/head hurt; A spontaneous report was received from a consumer, a 36 year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) 57 days after receiving first dose and developed an allergic reaction with generalized itching, swollen eyes, skin abrasions, throat swelling, chest tightness, chest erythema, elevated heart rate, nausea, vomiting, headache, anxiety attack and vaginal/vulvar rash. The patient's medical history include severe allergies NOS. Concomitant product included Benadryl prior to the second dose of the vaccine. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided). On 22-Feb-2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 22-Feb-2021 , immediately after receiving vaccine, the patient experienced an allergic reaction with generalized itching, swollen eyes, skin abrasions, throat swelling, chest tightness, chest erythema, elevated heart rate, nausea, vomiting, headache, anxiety attack and vaginal/vulvar rash. Treatment for the events included Phenergan, IV antihistamine, IV steroids, prednisone, hydroxyzine hydrochloride and EpiPen. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore, action taken with the drug in response to the event is not applicable. The outcome of the events, allergic reaction with generalized itching, swollen eyes, skin abrasions, throat swelling, chest tightness, chest erythema, elevated heart rate, nausea, vomiting, headache, anxiety attack and vaginal/vulvar rash, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's prior severe allergy history may have been contributory for the occurrence of the allergic reaction and associated events. Additionally, This report refers to a case of an inappropriate schedule of product administration for mRNA-1273, lot #011M20A.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,UNK,BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE],Allergic reaction NOS (Patient had severe allergies and carried an EpiPen.),,,,"['Allergy to vaccine', 'Anxiety', 'Chest discomfort', 'Erythema', 'Eye swelling', 'Headache', 'Heart rate', 'Heart rate increased', 'Inappropriate schedule of product administration', 'Nausea', 'Pharyngeal swelling', 'Pruritus', 'Skin abrasion', 'Vomiting', 'Vulvovaginal pruritus', 'Vulvovaginal rash']",2,MODERNA,OT 1090181,,,F,"3rd dose 28 days after the 2nd one; A Spontaneous report was received from a Pharmacist concerning a female patient in her 60s who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced third dose administered 28 days from second dose. The patient's medical history was not provided. Concomitant medications were not listed. On unknown date, the patient received their second dose of two planned doses mRNA-1273(Lot number: unknown) for prophylaxis of COVID-19 infection. On 22 Feb 2021, 28 days after second dose, the patient received third dose of the vaccine. Treatment information is not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of events, third dose administered 28 days from second dose was considered as recovered.; Reporter's Comments: This case concerns a female patient who received their third dose of mRNA-1273 (Lot unknown), reporting Extra dose administered without any associated adverse events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,02/22/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse reaction (No reported medical history.),,,['Extra dose administered'],3,MODERNA,OT 1090182,TN,,M,"Passed away; A spontaneous report was received from a consumer concerning a male patient of unknown age, who was received Moderna's COVID-19 vaccine (mRNA-1273) and died. The patient's medical history was not provided. No concomitant medications were reported. On an unknown date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. It was reported by the patient's wife that the patient died. She was calling to cancel his second dose of mRNA-1273. No additional details, including the date of death, were reported. Treatment information was not provided. Action taken with the mRNA-1273 was not applicable as the patient died. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Death'],1,MODERNA,OT 1090183,OH,80.0,F,"Diagnosed with c-diff; Feeling dizzy; A spontaneous report was received from a consumer concerning a 80-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and diagnosed with c-diff(Clostridium difficile infection) and feeling dizzy. The patient's medical history was not provided. No relevant concomitant medications were reported. On 29 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) via unknown route for prophylaxis of COVID-19 infection. On 29 Jan 2021, the patient experienced feeling dizzy. On an unknown date, the patient was diagnosed with c-diff(Clostridium difficile infection) and considered medically significant event. No treatment information was provided for the event feeling dizzy.Treatment for the event c-diff(Clostridium difficile infection) included high dose of antibiotic. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events c-diff (Clostridium difficile infection) and feeling dizzy was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,01/29/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Clostridium difficile infection', 'Dizziness']",2,MODERNA,OT 1090184,FL,,F,"Urinary tract infection; A spontaneous report was received from a consumer who was also an 84-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a urinary tract infection (UTI). The patient's medical history included voice larynx disorder ""frozen"". Concomitant product use was not provided. On 01-Feb-2021, prior to the onset of the event, the patient received their first of the two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly for prophylaxis of COVID-19 infection. On 24-Feb-2021, the patient developed a UTI. Treatment included antibiotics prescribed, but not taken by the patient. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event of UTI was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. However, patient's advanced age may have been contributory.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/24/2021,23.0,UNK,,,"Medical History/Concurrent Conditions: Vocal cord disorder NOS (reported description: voice larynx disorder ""frozen"")",,,['Urinary tract infection'],1,MODERNA,OT 1090185,,,M,"My 16 year old son can participate in your Covid 19; Received the first moderna vaccine by error of pharmacy; A spontaneous report was received from a reporter concerning a 16-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) by error of the pharmacy. The patient's medication history was not provided. Concomitant medications none. On 19 Feb2021 2021, the 16 year old patient received the first of the two planned doses of mRNA-1273 (lot/batch unknown) intramuscularly in the anatomical location in the for prophylaxis of COVID-19 infection. The pharmacy has shared with them that he can no longer receive his second vaccine due to their error. The patient's mother seems very interested in him getting his second vaccine and has asked to please let her know how this can be resolved Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events was considered as recovered or resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) and vaccination error for mRNA-1273 (lot number unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/19/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Product administered to patient of inappropriate age', 'Vaccination error']",1,MODERNA, 1090186,TN,64.0,F,"blood pressure was 286/89/blood pressure was so high; rapid heartbeat; severe inflammatory reaction; fever; headaches; body was in a weakened state; pain in arm; swelling up her arm/swelling in hands; had a severe reaction; swelling at injection site; hot; A spontaneous report was received from a consumer who was also a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe reaction (vaccination site reaction), swelling and warmth at vaccination site, pain in the arm, swelling up her arm/left hand swelling (peripheral swelling), inflammation, rapid heartbeat (heart rate increased), blood pressure was 286/89/blood pressure was so high (hypertension), fever (pyrexia), headache and weakened body state (asthenia). The patient's medical history, as provided by the reporter, pneumonia (had from Dec 2020 to Feb 2021 and had ""compromised lungs""), allergies to penicillin and sulfa drugs, vitamin D deficiency, pseudobulbar effect, and traumatic brain injury (with swelling on back of brain stem, memory loss, problems with speech). Concomitant medications included levothyroxine sodium, vitamin C, vitamin D, fish oil, tizanidine, and fluvoxamine. On 18 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:029L20A) in the left arm for prophylaxis of COVID-19 infection. On 18 Feb 2021, after receiving mRNA-1273 the patient reported to have a severe reaction to the vaccination. The patient had swelling at injection site which looked like a bee sting and felt hot. On 19 Feb 2021, the patient reported to experience swelling and very bad pain in left hand. The patient took Benadryl as a treatment. On 20 Feb 2021, terrible pain in arm was reported along with swelling. She went urgent care and they sent her to the hospital, where she stayed for about 8 hours. Test showed a severe inflammatory reaction. She also had headaches, her body was in a weakened state, pain went up her arm, she had a rapid heartbeat and a fever. The patient's blood pressure was 289/89 and they ""thought she was going to have a stroke or a heart attack"" because her blood pressure was so high. Treatment for the events included steroids and unspecified painkillers. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events peripheral swelling was considered to be not resolved at the time of reporting. The outcome of the events of severe reaction, swelling and warmth at vaccination site, pain in the arm, inflammation, rapid heartbeat, blood pressure was 286/89/blood pressure was so high, fever, headache, and weakened body state was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/18/2021,0.0,UNK,TIZANIDINE; FLUVOXAMINE; SYNTHROID; VITAMIN D [COLECALCIFEROL]; VITAMIN C [ASCORBIC ACID]; FISH OIL,Lung disorder (lung function compromised); Penicillin allergy (Allergy to Penicillin and Sulfa drugs); Pseudobulbar affect; Sulfonamide allergy; Vitamin D deficiency,Medical History/Concurrent Conditions: Brain swelling (swelling on back of brain stem); Memory loss; Pneumonia; Speech disorder (problems with speech); Traumatic brain injury,,,"['Asthenia', 'Blood pressure measurement', 'Headache', 'Heart rate increased', 'Hypertension', 'Inflammation', 'Laboratory test', 'Peripheral swelling', 'Pyrexia', 'Vaccination site pain', 'Vaccination site reaction', 'Vaccination site swelling', 'Vaccination site warmth']",1,MODERNA,OT 1090187,MI,47.0,F,"Extreme fatigue; Angioedema on soles of both feet; Itchiness; Rash on lower part of right wrist; Rash on the front part of the arm/anterior part of arm; Feet swelling; Fatigue; A spontaneous report was received from a consumer who is a 47-year-old, female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angioedema, rash and pruritus. The patient's medical history was not provided by the reporter. Concomitant medications reported included vitamins. On 25-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27-Jan-2021, the patient reported having rash on lower part of right wrist and arm, fatigue, feet swelling, itchiness and angioedema itchy (angioedema). On 22-Feb-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 25-Feb-2021, the patient reported having rash on the front part of the arm/anterior part of arm, extreme fatigue, itchiness, burning rash (not hives). No lab details were mentioned. Treatment for the events included Benadryl as instructed by her health care professional. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of events, angioedema, rash and pruritus, were considered unknown or not reported. The event angioedema was deemed medically significant.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/27/2021,2.0,UNK,VITAMINS NOS,,Medical History/Concurrent Conditions: No adverse reaction (No reported medical history),,,"['Angioedema', 'Fatigue', 'Peripheral swelling', 'Pruritus', 'Rash']",1,MODERNA,OT 1090188,AZ,,F,"Bleeding from papercut won't stop.; Till this day it has not healed; delayed healing; Itching in left arm near injection site; Scratched and arm turned orange; A spontaneous report was received from a consumer concerning a 70-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bleeding from papercut won't stop, till this day it has not healed, Itching in left arm near injection site, (arm) turned orange after scratching. The patient's medical history was not provided. Concomitant medications reported were Crestor, Zetia. On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, the patient experienced itching in her left arm near injection site. The patient scratched and her arm turned orange. On 14 Feb 2021, she got a paper cut which caused bleeding and till this day it had not healed. No treatment information was provided Action taken with mRNA-1273 in response to the events was unknown. The events of bleeding from papercut won't stop , till this day it has not healed were unresolved, while the outcome of the events of Itching in left arm near injection site, (arm) turned orange after scratching were unknown. The reporter did not provide an assessment for the event bleeding from papercut won't stop, till this day it has not healed, Itching in left arm near injection site, (arm) turned orange after scratching.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/13/2021,9.0,UNK,CRESTOR; ZETIA,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Haemorrhage', 'Impaired healing', 'Vaccination site discolouration', 'Vaccination site pruritus']",1,MODERNA,OT 1090189,IL,57.0,F,"acutely arthritic hands and wrists with swelling, redness, warmth and significant pain and reduced mobility; mild headache; mild injection site reaction/local site reaction (redness); A spontaneous report was received from a retired physician, who was also the husband of a 57 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild headache, mild injection site reaction/local site reaction (redness)/injection site erythema, and arthritic hands and wrists with swelling, redness, warmth and significant pain and reduced mobility/arthritis. The patient's medical history included gastroesophageal reflux disease. The patient had ongoing condition of multiple sclerosis. The concomitant medications included interferon beta-1a, esomeprazole magnesium, and escitalopram. On 16 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. The patient had experienced mild headache for first 12 hours post vaccination, local site reaction (redness) for 5 days after vaccination. On 25 Feb 2021, the patient experienced acute wrist, metacarpophalangeal, proximal interphalangeal and distal interphalangeal joint pain with swelling, reduced range of motion, redness and warmth in both hands though it started first in left hand. The patient was unable to pick glass of water due to significant pain which worsened in the morning gradually improving throughout the day. The reporter felt this event was disabling for the patient. Treatment information was not provided. Action taken with mRNA-1273 was unknown. The events of mild headache and mild injection site reaction/local site reaction (redness) were resolved. The event of arthritic hands and wrists with swelling, redness, warmth and significant pain and reduced mobility was not resolved at the time of this report.; Reporter's Comments: This case concerns a 57 year old, female patient, who experienced serious event of acute arthritis and non serious events of headache and vaccination site erythema. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/16/2021,02/01/2021,,UNK,REBIF; ESCITALOPRAM; NEXIUM [ESOMEPRAZOLE MAGNESIUM],GERD; Multiple sclerosis,,,,"['Arthritis', 'Headache', 'Vaccination site erythema']",1,MODERNA,OT 1090190,CA,78.0,F,"Burning; Allergic reaction; Hives all over her body; Face swelled up; Lips welled up; Throat swelled up; A spontaneous report, was received from a consumer (patient's daughter), concerning a 78 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced allergic reaction (hypersensitivity), hives all over her body (urticaria), face swelled up (swelling face), lips swelled up (lip swelling), throat was swelled up (pharyngeal swelling), and burning (burning sensation). The patient's medical history was not provided. No relevant concomitant medications were reported. On 04-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly for the prophylaxis of COVID-19 infection. On 06-Feb-2021, approximately 48 hours after vaccination, the patient developed allergic reaction and had hives all over her body. The patient received diphenhydramine for hives. The patient also stated that inside of her was burning, face swelled up, lips swelled up and throat swelled up. The patient rushed to emergency room (ER). They needed to take the patient to an allergist because they wanted to find out if this was related to the vaccine. The allergist told her that they couldn't do an allergy testing. The patient asked if there were any reports on people showing allergic reaction 48 hours later after the vaccine. The patient was scheduled to get the second dose. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of events, allergic reaction, hives all over her body, face swelled up, lips swelled up, throat was swelled up, and burning, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Yes,Not Reported,,Not Reported,U,02/04/2021,02/06/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Burning sensation', 'Hypersensitivity', 'Lip swelling', 'Pharyngeal swelling', 'Swelling face', 'Urticaria']",1,MODERNA,OT 1090191,,97.0,F,"Hallucinating; Occasional rapid heart beat; Hadache; A spontaneous report was received from a caregiver concerning reporter's mother a 97-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced hallucinating/ hallucination, occasional rapid heartbeat/ heart rate irregular and headache. The patient's current conditions included chronic urinary tract infection. Products known to have been used by the patient, within two weeks prior to the event, included antibiotics for chronic urinary tract infection. On 26-Feb-2021, prior to the onset of the symptoms, the patient received their unspecified dose of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route and site for prophylaxis of COVID-19 infection. On 27-Feb-2021 the patient had headache for 2 days, was hallucinating and had occasional rapid heartbeat. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The Outcome of the events, hallucinating, occasional Rapid Heartbeat, and headache was unknown. Company Comment: The reported events, hallucinations, heart rate irregular, and headache, were considered possibly related to mRNA-1273.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported event and excluding any other etiology, a causal relationship with the event cannot be excluded. Headache is consistent with the vaccine profile",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/26/2021,02/27/2021,1.0,UNK,ANTIBIOTICS,"Urinary tract infection NOS (on antibiotics, medication name not specified)",,,,"['Hallucination', 'Headache', 'Heart rate irregular']",1,MODERNA,OT 1090192,CT,78.0,M,"He could hardly walk, legs gave out and he fell and could not get up; Can't lift legs; No strength in the legs and arms; A spontaneous report, was received from a consumer (patient), a 78 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced he could hardly walk, legs gave out and he fell and could not get up (monoplegia), can't lift legs (muscular weakness), and no strength in the legs and arms (muscular weakness). The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient stated that the morning on 13 Feb 2021, after the vaccine was administered, the patient could hardly walk legs gave out and he fell and could not get up, no strength in the legs and arms, and can't lift legs. The patient was now able to feel everything normal as of this morning on 14 Feb 2021. No treatment details were provided. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of events he could hardly walk, legs gave out and he fell and could not get up, can't lift legs, and no strength in the legs and arms were considered resolved on 14 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/12/2021,02/13/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Monoplegia', 'Muscular weakness']",1,MODERNA,OT 1090193,TX,63.0,F,"Lupus got worse; Lot of bleeding from her womb and rectum; Lot of bleeding from her womb and rectum; COVID positive; Dizzy; Strong reaction; Can't get out of bed; A spontaneous report was received from a consumer who was also a 63-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced Lupus got worse, lot of bleeding from her womb and rectum,COVID positive, dizzy, strong reaction and can't get out of bed. The patient's medical history included lupus. Concomitant medications included prednisone, enoxaparin, folic acid and pain killers. On 12 Jan 2021, approximately fifteen days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, 15 days later, patient had a ""strong reaction"" and went to the hospital where patient got diagnosed with COVID. Patient says patient cannot even stand, felt dizzy and had to lay in bed all day. The patient had lupus, which worsened after vaccination. She had a lot of bleeding from womb and rectum. Patient said she won't get the second dose because it will kill patient. Treatment for the event included tylenol but symptoms did not get better. The mRNA-1273 was withdrawn in response to the events The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding the event -tested positive has been provided at this time. Further information has been requested. However, based on the mechanism of action of mRNA-1273, the event- COVID-19 is assessed as unlikely related to mRNA-1273.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/12/2021,01/27/2021,15.0,UNK,PREDNISONE; ENOXAPARIN; FOLIC ACID,Syndrome lupus (Lupus),,,,"['COVID-19', 'Dizziness', 'Fatigue', 'Nonspecific reaction', 'Rectal haemorrhage', 'SARS-CoV-2 test', 'Systemic lupus erythematosus', 'Urethral haemorrhage']",1,MODERNA,OT 1090194,NC,,F,"Shortness of breath, she was gasping for air, her oxygen level was really low; Affect her lungs, her heart and esophagus; Tightness on the chest; Fatigue; Chills; Headache; Stomach pain; A spontaneous report received from a Consumer concerning, a female patient of unspecified age who received first dose of the Moderna (mRNA-1273) and experienced tightness in chest, affected lungs, heart and esophagus, shortness of breath, fatigue, chills, headache and stomach pain. The patient's medical history included cancer survivor, heart attack, numerous surgeries, asthma and CPAP machine. Patient's concomitant included albuterol, aspirin, buspirone, covitol, B12 injections once a month, cyclobenzaprine, levoxacin, Vit D, ezetimibe, fexofenadine, Advil, levothyroxine, Nasonex, Montelukast, niacin, Xolair injection once a month, oxybutynin, prosol, potassium chloride, primidone, raloxifene, Ramipril, tiotropium bromide, tramadol, zinc and pepsin. On 30 Dec 2020 date, the patient received their first dose of the two planned doses of mRNA-1273 in right arm (Batch #: 011J204) intramuscularly in the right arm for prophylaxis of COVID-19 infection. Patient stated she received her first dose of the Moderna COVID19 on 30 Dec 2020 and she experienced tightness on the chest immediately. The next day 31 Dec 2020 she felt worse, so she went to the ER and she was told that it was a reaction to the vaccine. Then, 01 Jan 2021 she went to urgent care because she was feeling worse and they gave her prednisone. Patient stated she then went to the pulmonologist and a few days later, she was admitted to the hospital. She said it affected her lungs, her heart and esophagus. She stated that the symptoms are still ongoing, she was still having issues. Treatment received was prednisone and breathing treatment was oxygen steroids. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events tightness in chest, affected lungs, heart and esophagus, shortness of breath, fatigue, chills, headache and stomach pain was not recovered.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,12/30/2020,12/30/2020,0.0,UNK,ALBUTEROL HFA; ASPIRIN (E.C.); BUSPIRONE; COVITOL; B12 [CYANOCOBALAMIN]; CYCLOBENZAPRINE; LEVOXACIN; VIT D [COLECALCIFEROL]; EZETIMIBE; FEXOFENADINE; ADVIL ULTRA [IBUPROFEN]; LEVOTHYROXINE; NASONEX; MONTELUKAST; NIACIN; XOLAIR; OXYBUTYNIN;,,Medical History/Concurrent Conditions: Asthma; Cancer; CPAP; Heart attack; Surgery,,,"['Abdominal pain upper', 'Chest discomfort', 'Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Pneumomediastinum']",1,MODERNA,OT 1090195,LA,73.0,F,"Right six cranial nerve palsy; A spontaneous report was received from a consumer concerning a 73-year-old, female patient, who developed right six cranial nerve palsy/facial paralysis. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. In January 2021 (date not specified), approximately 2 weeks prior to the onset of symptoms, the patient received the first dose of two planned doses mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient developed right six cranial nerve palsy. She consulted a physician and a CTR (not further specified) and magnetic resonance imaging were scheduled. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of event, right six cranial nerve palsy, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse reaction (No medical history reported.),,,['Cranial nerve paralysis'],1,MODERNA,OT 1090196,PA,,M,"immediately after getting the vaccine he started with like a post nasal drip cough, now he was not sick before or anything like that; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 08Feb2021, this case now contains all required information to be considered valid. A contactable consumer (patient's wife) reported that a 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included drug hypersensitivity (reported as allergic to penicillin and all Cephalosporins), anaphylactic shock (reported as anaphylactic shock reaction to these medications), cerebrovascular accident (reported as strokes since age 35), paralysis (paralyzed on his right side), cardiac operation (open heart surgery), endarterectomy (had 3 Endarterectomy on his neck which none of them taken), and drug hypersensitivity (allergic to penicillin and all sulphur form drugs). Concomitant medications were not reported. The patient immediately after getting the vaccine started with like a post nasal drip cough on an unspecified date, now he was not sick before or anything like that. Clinical outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Allergy to antibiotic; Anaphylactic shock; Endarterectomy (had 3 Endarterectomy on his neck which none of them taken); Open heart surgery; Paralyzed; Penicillin allergy; Stroke (suffered strokes since age 35); Sulfonamide allergy (He allergic to Penicillin and all Sulphur form drugs.),,,['Upper-airway cough syndrome'],1,PFIZER\BIONTECH, 1090197,CA,62.0,F,"After 1 hour facial swelling; After 45 minutes cheeks red; After 30 minutes face felt very hot; Stronger pain at injection site than with yearly flu shot; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old female patient (who was not pregnant at time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 25Jan2021 13:15, as single dose for COVID-19 immunization, at hospital. Medical history included Allergy to All pain relievers and anti-inflammatory drugs and over the counter, allergies to penicillin and Allergies to sulfites all types. Patient was not allergic to Keflex injections, but allergic to the pull form. Concomitant medications included amlodipine, fluticasone propionate (FLONASE), famotidine (PEPCID AC), calcium, colecalciferol (CALCIUM/VIT D) and one a day multi vitamin (within 2 weeks of vaccination). Patient previously took cefalexin (KEFLEX), Bacitracin, Neomycin, Lidocaine, Prednisone; had allergies with these all medications. Historical vaccine included influenza vaccine (FLU SHOT) and had Pain at injection site. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. After 30 minutes of vaccine, face felt very hot. After 45 minutes cheeks red. After 1-hour facial swelling. Took 1 Benadryl tablet after noticing swelling. Heat and redness then faded. Facial swelling reduced over the next 24 hours without more Benadryl. Stronger pain at injection site than with yearly flu shot, for which patient was not received treatment. Seriousness of the events was reported as non serious. Outcome of the events was recovered in Jan2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/25/2021,01/25/2021,0.0,PVT,AMLODIPINE; FLONASE; PEPCID AC; CALCIUM/VIT D,,Medical History/Concurrent Conditions: Drug allergy (Allergy to All pain relievers & anti inflammatory drugs RX and over the counter); Penicillin allergy (allergies: penicillin); Reaction to sulfites (Allergies: Sulfites all types),,,"['Erythema', 'Feeling hot', 'Swelling face', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1090198,MI,48.0,F,"Chills; Pain in hips; Cramping in abdomen; Pain in left ear; This is a spontaneous report from a contactable consumer(patient) reported that. A 48-years-old female patient started to receive bnt162b2 (BNT162B2Formualation:Solution for injection ) ,via an unspecified route of administration from 28Jan2021 14:45 to 28Jan2021 14:45 at SINGLE DOSE for an unspecified indication .Medical history included sialadenosis from an unknown date and unknown if ongoing , cervix carcinoma from an unknown date and unknown if ongoing , covid-19 from an unknown date and unknown if ongoing If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The patient experienced chills on 28Jan2021 19:00 , pain in hips on 28Jan2021 19:00 cramping in abdomen on 28Jan2021 19:00 pain in left ear on 28Jan2021 19:00 and The patient underwent lab tests and procedures which included body temperature: 97.3 on Temperature under the tongue was 97.3 and outcome of the events was unknown Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/28/2021,0.0,PUB,,,Medical History/Concurrent Conditions: Cervical cancer; COVID-19 (If covid prior vaccination: Yes); Sialadenosis,,,"['Abdominal pain', 'Arthralgia', 'Body temperature', 'Chills', 'Ear pain']",1,PFIZER\BIONTECH, 1090199,NC,57.0,F,"chills; fatigue/severe fatigue; subjective cold; myalgias; felt feverish, but always below normal temperature; This is a spontaneous report from a contactable physician for herself. A 57-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248) on 11Jan2021 via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization in the hospital. Patient's medical history included hyperlipidaemia from an unknown date and unknown if ongoing. The patient previously had erythromycin and had allergies. Concomitant medication included Lipitor (Atorvastatin calcium). Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) on 16Dec2021 via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient did not have any other vaccine within four weeks. The patient did not receive COVID-19 vaccine prior to vaccination. The patient experienced chills, fatigue/severe fatigue, subjective cold, myalgias, felt feverish and but always below normal temperature in Jan2021. The patient was underwent COVID-19 (Nasal Swab) on 18Jan2021 which was negative. The patient didn't receive treatment. The outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/11/2021,01/01/2021,,PVT,LIPITOR [ATORVASTATIN CALCIUM],,Medical History/Concurrent Conditions: Hyperlipidaemia,,,"['Chills', 'Fatigue', 'Myalgia', 'Nasopharyngitis', 'Pyrexia', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1090200,TN,76.0,M,"Exacerbation of previously controlled hypertension with blood pressure spiking to 200/100; Had skeletal chest pain; doing well until Covid vaccine; This is a spontaneous report from contactable physicians (one of which was the patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration at the right arm on 22Jan2021 08:30 at single dose for COVID-19 immunization. Vaccination was done in a TN. Medical history included CABG Post op RT CABG (coronary artery bypass; doing well until Covid vaccine) from 11May2020 and hypertension. Concomitant medication included metoprolol succinate (TOPROL), ubidecarenone (COQ10), losartan and Hybrid. There was no other vaccine receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took atorvastatin (LIPITOR) and experienced allergies: Lipitor. The patient experienced exacerbation of previously controlled hypertension with blood pressure spiking to 200/100 on 26Jan2021, went to local ER, BP 180/100 there on 26Jan2021. He had skeletal chest pain which began 25Jan2021 22:00. He stated post op right cabg from 11may2020, doing well until covid vaccine on 22Jan2021. Treatment IV Hydralazine received. The events were considered non-serious by the reporter. On 26Feb2021, it was reported that the patient provided information to another physician regarding the reported adverse events with the use of BNT162B2. The physician did not consider the Pfizer product had a causal effect to the adverse events. Lab data also included Covid test (rapid nasal swab) on 26Jan2021 was negative. The outcome of the events was not recovered. Follow-up (26Feb2021): New information received from a contactable physician in response to HCP letter sent includes: reporter details (added a physician as a reporter), causality assessment and clinical course details. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT62B2 to the events hypertension aggravated, skeletal pain and unwell cannot be excluded. The fluctuation of underlying hypertension may be major cofounder. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/22/2021,0.0,UNK,TOPROL; COQ10; LOSARTAN,,Medical History/Concurrent Conditions: CABG (Doing well until Covid vaccine.); Hypertension,,,"['Blood pressure measurement', 'Bone pain', 'Hypertension', 'Malaise', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1090201,NJ,79.0,F,"arm swelled up/had arm swelling; little discomfort with the needle; some blood on the band-aid; felt achy in her arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in arm in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that when she got the first dose of the vaccine in Jan2021, she felt that the needle went in, she felt a little discomfort with the needle, had some blood on the band-aid, she felt achy in her arm afterwards in Jan2021; and her arm swelled up/had arm swelling on unspecified date. She did not feel anything with the second dose and there was no swelling like the first time. She asked the nurse if it went in for the second dose and the nurse said it did. The patient mentioned that there was nothing that showed like anything went in her arm when she received the second dose. She heard that the second one should feel something going on more than first time. She did not know if she could get another vaccination or what she needed to do. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,01/01/2021,0.0,UNK,,,,,,"['Pain in extremity', 'Peripheral swelling', 'Vaccination site discomfort', 'Vaccination site haemorrhage']",1,PFIZER\BIONTECH, 1090202,TX,83.0,F,"she is short of hearing; losing her breathe; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown) via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunization. The patient's medical history included: Stage 3 lung cancer, radioactive therapy on 25Dec2020 to 31Dec2020 (Also reported as 2-days prior to her 1st vaccine shot, the nurse gave her 2 radioactive therapy and the last one was 31Dec2020), immune therapy on 01Jan2021 (7 weeks' worth received all in 7 days), and steroid therapy on December 2020 and Jan2021. The patient had terrible reaction from the immune therapy on an unspecified date which include all the skin of her mouth had ulcers, had such sickness, diarrhea, a rash all over the face, had headaches, was so fatigued, no energy and could not get out of bed. Patient felt better in the past few days. Other medical history included had a bad fall, two broken ribs and needed hip replacement surgery from unspecified dates. She lives alone and received 700 units a day of steroids for 10-days last December. Family history included lung cancer runs in her family (sister and brother died of lung cancer, other sister got it too). Patient stated her doctor called her in 2 days before and stated her next step was immune therapy, she has had massive doses of radioactive before, she had 7 weeks of that in 10 days, and had an extreme reaction from that, the last one was 31Dec2020. Concomitant medications were not reported. The patient stated she refused her immune therapy, as she wanted the vaccine. It was put down as she did not want it. The patient reported that nurse there then said she was going to be put on unspecified steroid, which she never had before. Her friend picked up the prescription and, without reading everything, and she usually does, she took two of them. It said take all 6 that evening, but she took 2 then read and it said not to take with any vaccine. She stated that the nurse knew how she stressed she wanted the vaccine, and so she had the COVID vaccine. She just had the two steroids, and she said she wanted to wait until Mar2021 until she considered getting immune therapy, but the nurse booked her for 26Feb2021, and she had her second vaccine from Pfizer scheduled on 19Feb2021 one week apart. She asked if that is too soon, and does she need to put off immune therapy again. She read it is 2-3 weeks between, she wanted to have this verified. Patient stated she supposed to take 6 steroids then 5 and so on. She took 2 pills then as she was reading information regarding the vaccine, she did not take anymore. Last week is when she took the two steroids, she won't take them. She called a pharmacist, who said do not take them. The doctor's office, the nurse, gave them, after she told them she would have the vaccine. She stated she was furious, but she was getting this all the way down the line. She put the steroids away, she said she was not taking them, she talked to someone in the medical field and told her how she felt, and she agreed. Patient asked if it will be ok to have the immune therapy at that time and soon after getting the vaccine if it would be effective. She mentioned that at her age she is more concerned that she gets that vaccine and she wants to delay having the immune therapy until March given the horrible reaction she had before. She tried and tried to have this conversation with her doctors, but she does not have all that technology and they are only offering remote appointments. Patient stated that she had no problems from the first dose of the vaccine stating she did not even feel the needle. She has been exactly an hour on the phone. The patient stated that she was losing her breathe after speaking at this time during the call on 05Feb2021. She also stated she is short of hearing (onset date unknown). Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,02/05/2021,7.0,UNK,,,"Medical History/Concurrent Conditions: Diarrhea; Energy decreased; Fall (needed hip replacement surgery); Fatigue; Headache; Immunomodulatory therapy; Lung cancer (sister and brother died of lung cancer, other sister got it too); Lung cancer stage III; Mouth ulcer; Radiation therapy (Also reported as 2-days prior to her 1st vaccine shot, the nurse gave her 2 radioactive therapy. the last one was 31Dec2020); Rash face; Rib fracture; Sickness; Steroid therapy (For 10 days last december Also on Jan2021)",,,"['Dyspnoea', 'Hypoacusis']",1,PFIZER\BIONTECH, 1090203,IN,47.0,M,"Sore arm; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EL3302, via an unspecified route of administration in left arm on 05Feb2021 10:15 at a single dose for covid-19 immunization in a military base at age 47 years old. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm on 05Feb2021 10:15. The event was reported as non-serious. No treatment was received from the adverse event. The patient recovered from the event on an unspecified date in Feb2021. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,MIL,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1090204,,,U,"2 of the doctors did not convert with antibody test which was performed about 10-18 days after the 2nd Pfizer vaccine dose; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unknown), both via an unspecified route of administration on unspecified dates and at single dose for COVID-19 immunisation. The patient received the product in the hospital. The patient's medical history and concomitant medications were not reported. The physician reported that several doctors have received both vaccines and 2 of the doctors ""did not convert with antibody test."" HCP stated the test was performed ""about 10-18 days after the 2nd Pfizer vaccine dose."" The patient underwent lab tests and procedures which included COVID-19 antibody test: did not convert with antibody test on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171614 same drug/reporter/event, different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PVT,,,,,,"['SARS-CoV-2 antibody test', 'SARS-CoV-2 antibody test negative']",2,PFIZER\BIONTECH, 1090205,SC,71.0,M,"first dose of Pfizer-Biontech Covid19 vaccine on 22Jan2021/ 03Feb2021 of a runny nose/ covid19 test (06Feb2021)/ it came back positive, this morning (08Feb2021); first dose of Pfizer-Biontech Covid19 vaccine on 22Jan2021/ 03Feb2021 of a runny nose/ covid19 test (06Feb2021)/ it came back positive, this morning (08Feb2021); This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 71-year-old male patient (also age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9262, expiry date: May2021), intramuscular on 22Jan2021 at SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received his first dose of Pfizer-Biontech Covid19 vaccine on 22Jan2021 and due his second COVID shot tomorrow (09Feb2021). The wife started feeling ill 26Jan2021 and she thought just had sinus infection but she went Sunday 31Jan2021 and had a swab test done and she got swabbed then Monday (results 01Feb2021) she found out she was positive for COVID. The patient took a rapid test that same Monday (01Feb2021) and the rapid test was negative. He reports Covid symptoms on 03Feb2021 of a runny nose-no fever, chills, or diarrhea. He went for a second saliva-based covid19 test (06Feb2021: confirmed by the patient), and it came back positive, this morning (08Feb2021). It was added that the patient had not showed any symptoms through all that time until 03Feb2021 he had a runny nose for one afternoon and that was it and so with the second vaccine on the 09Feb2021 and him being exposed he thought he would get a test Saturday (06Feb2021), he had a saliva test and he got the results today that unfortunately were positive but he still hasn't showed any symptoms other than a runny nose for one afternoon. he has not had fever or none of the flu like symptoms. He is asking for some information he is hoping for anyway. The patient asked if he should go ahead to get the second shot. and he's looking for guidance on getting his second vaccine dose, tomorrow, or not? What is the recommended interval? What if he waits 4 weeks? He is wondering what to do about 2nd dose, as he is concerned with the timeline. The outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,02/06/2021,15.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1090206,PA,54.0,M,"Severe stomach cramps; Severe diarrhea; He felt like he was running a fever; Chills; Sweats; Shakes; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer-sponsored program. A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular on 02Feb2021 at around 10:00 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient had a family history of dementia. Concomitant medications were not reported. The patient did not receive other vaccines within 4 weeks prior to vaccination. About 36 hours after getting the vaccination (unknown date Feb2021), the patient experienced severe stomach cramps, severe diarrhea, felt like he was running a fever, chills, sweats, and shakes. The clinical outcome of the stomach cramps, diarrhea, fever, chills, sweats and shakes was recovered on an unknown date in Feb2021 (symptoms lasted about 18-24 hours).",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/01/2021,,PVT,,,Medical History/Concurrent Conditions: Dementia (Family has history),,,"['Abdominal pain upper', 'Chills', 'Diarrhoea', 'Hyperhidrosis', 'Pyrexia', 'Tremor']",1,PFIZER\BIONTECH,OT 1090207,MA,69.0,U,"I have a big black and blue area where I received the shot; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old patient of unknown gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 28Jan2021 12:00 PM at single dose in left arm for COVID-19 immunization at Nursing Home/Senior Living Facility. Medical history was reported as patient had COVID prior vaccination. Concomitant medications was none. Patient just wanted to know that if the vaccine will be effective if the needle went into a vein in the upper arm. patient had a big black and blue area where the shot was received on 28Jan2021. No treatment for adverse event. No other vaccine in four weeks. No COVID tested post vaccination. The outcome of event was unknown. Information about batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,01/28/2021,0.0,SEN,,,Medical History/Concurrent Conditions: COVID-19,,,['Vaccination site bruising'],UNK,PFIZER\BIONTECH, 1090208,VA,,F,"Chills; Muscle pain; Fatigue; Flu like symptoms; Arm swollen size of a baseball and radiating heat at site.; Arm swollen size of a baseball and radiating heat at site.; This is a spontaneous report from a Non-contactable consumer. A adult female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for covid-19 immunisation. the patient's medical history included covid-19 (If covid prior vaccination: Yes). She was vaccinated on a Monday. Tuesday, the patient experienced chills, muscle pain, fatigue, flu like symptoms. Friday she experienced arm swollen size of a baseball and radiating heat at site. This Adverse event resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment. The outcome of the events was recovered. No follow-up attempts are possible. Information about batch/Lot number can not be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,PVT,,,Medical History/Concurrent Conditions: COVID-19 (If covid prior vaccination: Yes),,,"['Chills', 'Fatigue', 'Influenza like illness', 'Injection site warmth', 'Myalgia', 'Peripheral swelling']",1,PFIZER\BIONTECH, 1090209,MA,26.0,F,"Very sore arm; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Not available/provided to reporter at the time of report completion), via an unspecified route of administration from 22Dec2020 to 22Dec2020 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Other vaccine in four weeks was unknown. Covid prior vaccination and Covid tested post vaccination was unknown. The patient experienced very sore arm (pain in extremity) (non-serious) on 23Dec2020. This report is for the first vaccination only. I will put a second report in for adverse events reported for the second vaccination as well. The outcome of event was recovered on an unspecified date. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/22/2020,12/23/2020,1.0,UNK,,,,,,['Pain in extremity'],1,PFIZER\BIONTECH, 1090210,NY,70.0,F,"Knee pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the patient, reported that a 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL8982, first dose) solution for injection intramuscular on 27Jan2021 (at the age of 70-years-old) at single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. The patient experienced knee pain after the first vaccine in 2021 and her orthopedic doctor recommended an oral steroid for 6 days. The patient had a knee procedure (unrelated to vaccine) and was prescribed methylprednisolone to address the pain. MRI on an unknown date with unknown results. The outcome of the event knee pain was unknown. The consumer stated that the knee pain was unrelated to COVID vaccine.; Sender's Comments: The event Arthralgia is most likely related to an intercurrent or underlying condition which may not be related to the suspected drug BNT162B2. Knee procedure may provide an explanation for the event. The case will be reassessed if additional information becomes available.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,,,UNK,,,,,,"['Arthralgia', 'Magnetic resonance imaging']",1,PFIZER\BIONTECH,OT 1090211,AL,,F,"she got Covid virus; she got Covid virus; This is a spontaneous report from a Pfizer-sponsored program via a contactable Nurse reported for herself. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that she already got the first dose of her COVID Vaccine and after that she got COVID virus on an unspecified date. Patient lab data included she got COVID virus on an unspecified date. She wanted to know if she should continue to get her 2nd dose or what she should do. Outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1090212,WI,,M,"Blood sugar went up; This is a spontaneous report from a contactable consumer (patient) via medical information team and a Pfizer-sponsored program . A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date were unknown) via an unspecified route of administration on 11Feb2021 at single dose to prevent COVID-19 virus. Medical history included that he was legally blind and he did not drive; his oncologist told him to take the Pfizer COVID-19 Vaccine because he has Leukemia, to prevent the COVID-19 virus that has been going around; this consumer was a type II diabetic and he took his blood sugar every morning. The patient's concomitant medications were not reported. He had an injection of BNT16B2 on 11Feb2021 afternoon and his blood sugar spike up on 12Feb2021. The outcome of event was unknown. Information on batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/12/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Blind; Diabetic; Leukemia,,,"['Blood glucose', 'Blood glucose increased']",1,PFIZER\BIONTECH, 1090214,CA,51.0,M,"Alopecia universalis; This is a spontaneous report from a contactable physician. A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via intramuscular route of administration on 20Dec2020 (at the age of 51 years-old) as a single dose for COVID-19 vaccination. Medical history included erectile dysfunction and GERD. The patient had no known allergies. The patient's concomitant medications were not reported. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID prior to vaccination. The patient was tested for COVID post vaccination on an unknown date and the COVID test result was negative. On 21Dec2020 the patient experienced alopecia universalis- onset after 1st shot, mild. The event alopecia universalis resulted in a physician office visit. The patient was treated for the alopecia universalis with Minoxidil, allegra, prednisone started on 08Feb2021. The clinical outcome of the alopecia universalis was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/21/2020,1.0,UNK,,,Medical History/Concurrent Conditions: Erectile dysfunction; GERD,,,"['Alopecia universalis', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH,OT 1090215,NJ,72.0,F,"Head cold; Diarrhea; developed a kind of allergies like a scratchy throat; Congested; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9262), via an unspecified route of administration on 25Jan2021 (at the age of 72-years-old) as a single dose for COVID-19 immunization. The patient's medical history included 'thyroid' from an unspecified date and unknown if ongoing. Concomitant medications were not reported. On an unknown date, reported as all of the sudden, the patient experienced a kind of allergy like a scratchy throat and then I was congested, a bad head cold (started last week) and from last night I started to have diarrhea. The clinical outcome of head cold, diarrhea, scratchy throat and congested was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,,,UNK,,,Medical History/Concurrent Conditions: Thyroid disorder,,,"['Diarrhoea', 'Nasal congestion', 'Nasopharyngitis', 'Throat irritation']",1,PFIZER\BIONTECH, 1090216,NY,,F,"light headed / dizziness; blood pressure increased/ blood pressure went up to 170/90; pulse increased/ heart rate (HR) was 85; head felt hazy, foggy/ felt foggy and just weird; jittery; headache; I feel like I get a little hot; I get a little cramping and have to have a bowel movement; I get a little cramping and have to have a bowel movement; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a female patient of unspecified age (reported as 57 with units unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on 27Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included at the age menopause. Concomitant medications were not reported. The patient previously took levothyroxine for thyroid disease; and hydroxychloroquine (PLAQUENIL) she was taking this because she has a connective tissue disease. The patient previously received the first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization and became light headed. The patient received the 1st dose of Pfizer COVID vaccine on 06Jan2021, she felt fine, she only felt a little light headed but nothing significant. The patient was fine up until the second dose. On 27Jan2021, she received the Pfizer COVID vaccine 2nd dose, while being monitored, after 10 minutes, she felt light headed, her blood pressure went up to 170/90 and her heart rate (HR) was 85. She felt weird like I was going to die, they monitored the patient for another 15 minutes, her blood pressure came down to 130/74 and HR in the 70s. On the same day, she was jittery, pulse increased, blood pressure increased, dizziness and light headed. The same day she went back to work, took the second dose around 13:00 and at 17:00 of that same day she started feeling her old self. A week later the same symptoms came back. The symptoms have not gone away as of 23Feb2021. She was wondering if this was still a reaction to the vaccine. The following Wednesday, she started feeling the same way again, feeling light headed, felt foggy and just weird. She thought she wasn't going to be able to work but got through the day. From that day on, she continued to have this feeling. The patient was always light headed, dizzy, jittery, but not as bad at first, sometimes she has a headache. She was not back to my normal self. Sometimes, she felt like she get a little hot, she was at the age of menopause, she was not sure, it has affected her GI system, she get a little cramping and have to have a bowel movement, she never felt this way before. The patient was calling to see if anyone is calling with these symptoms and to shed some light on how long these last. The patient was still feeling light headed, dizzy, jittery, head felt hazy, foggy. The patient asked if there is a registry for patients with special conditions, underlying conditions, or comorbidities who receive the COVID-19 vaccine, this would include pregnancy and lactation as well. The outcome of the events blood pressure increased/ blood pressure went up to 170/90 and pulse increased/ heart rate (HR) was 85 were recovering; events light headed / dizziness, head felt hazy, foggy/ felt foggy and just weird, and jittery were not recovered and outcome of the other events was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Menopausal,,,"['Abdominal pain', 'Blood pressure increased', 'Blood pressure measurement', 'Bowel movement irregularity', 'Dizziness', 'Feeling abnormal', 'Feeling hot', 'Feeling jittery', 'Headache', 'Heart rate', 'Heart rate increased']",2,PFIZER\BIONTECH, 1090217,TX,39.0,F,"Miscarriage; This is a Spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus. This is the maternal report. A 39-year-old female consumer reported that a 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9269), via an unspecified route of administration at left arm on 04Feb2021 14:00 at a single dose for COVID-19 immunization. Medical history included allergies: Penicillin. No other vaccine in four weeks. Concomitant medications included (in two weeks) Prenatal vitamin, colecalciferol (VITAMIN D), folic acid (FOLATE) and sertraline hydrochloride (ZOLOFT 25mg). The patient's last menstrual date was 14Dec2020 and the delivery date was on 17Sep2021 (Gestational period: 8, as reported). An OB exam on 03Feb2021 showed healthy baby at 7w5d- heartbeat detected 152bpm; no abnormalities identified via ultrasound, Labs and hormone levels all within normal ranges. No issues detected. Mother received 1st dose of vaccine 04Feb2021. Per ultrasound on 20Feb2021, fetus stopped growing on 09Feb2021 (8w4d); no heartbeat detected. Miscarriage occurred 22Feb2021. AE resulted in Emergency room/department or urgent care, congenital anomaly (as reported). No treatment was administered. No COVID prior vaccination. Patient not COVID tested post vaccination. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225027 fetus case",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/22/2021,18.0,UNK,VITAMIN D; FOLATE; ZOLOFT,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Abortion spontaneous', 'Heart rate', 'Investigation', 'Laboratory test', 'Ultrasound scan']",1,PFIZER\BIONTECH, 1090218,NY,67.0,F,"syncope; feeling of heat rising into throat; feeling of heat rising into throat; lightheaded; chills; mild pain at injection site; This is a spontaneous report from a contactable pharmacist reported for self. This 67-year-old female patient (no pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 13:45 PM on Arm left via Intramuscular at single dose (Lot # EL9269) for covid-19 immunisation. Medical history included Osteoporosis, known allergies: Sulfa, flu vaccine for immunisation. No COVID prior vaccination. Concomitant medications included alendronate sodium (FOSAMAX), ergocalciferol (VITAMIN D), calcium, magnesium, biotin, bifidobacterium lactis (PROBIOTIC). No other vaccine in four weeks. Past similar reaction from Flu vaccine 8 years ago (2013) for immunisation and treated in ED, had no problems with any other vaccine such as HepB (Hepatitis B), DTAP, pneumococcal 23, Shingrix all for immunization. On 17Feb2021 14:15 PM, feeling of heat rising into throat, then lightheaded- EMT on-site monitored BP, heart, oxygen then administered IV Benadryl and zofran - signed out in 2hr, developed chills and syncope for next 4 days and mild pain at injection site. Self treated with Tylenol/ advised by MD to not get 2nd dose. Events resulted in emergency room/department or urgent care. Treatments were received for the events. Treatment included IV Benadryl and IV Zofran. Outcome of the events was recovering.; Sender's Comments: Based on a temporal association, a causal relationship between the events of feeling of heat rising into throat, lightheaded and syncope, and BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/17/2021,0.0,PUB,FOSAMAX; VITAMIN D [ERGOCALCIFEROL]; CALCIUM; MAGNESIUM; BIOTIN; PROBIOTIC [BIFIDOBACTERIUM LACTIS],,"Medical History/Concurrent Conditions: Osteoporosis; Sulfonamide allergy (known allergies: Sulfa, flu vaccine)",,,"['Blood pressure abnormal', 'Chills', 'Dizziness', 'Feeling hot', 'Investigation', 'Oxygen saturation', 'Syncope', 'Throat irritation', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1090219,NY,48.0,F,"COVID-19 pneumonia; Fever (body temperature at 102.7 Fahrenheit); Threw up; littles scratchy throat; Cough; Sore throat; Dizzy spells; Runny nose /nose was a faucet; Little sore arm; Fatigue; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 48-year-old female patient (weight: 148.32 kg, height: 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL9262) intramuscularly, in the left arm, at single dose, on 28Jan2021, at 13:30, for COVID-19 immunisation. Relevant medical history included light Crohn's disease from an unspecified date. Concomitant medications included oral fexofenadine hydrochloride (ALLEGRA) 60 mg, twice daily (60 mg, 1 tablet every 12 hours), from 02Feb2021 to 05Feb2021, for nasal congestion; oral paracetamol (TYLENOL, capsule) 500 mg capsule (she took 2 as needed), from 02Feb2021 and ongoing, for fever and headache; salbutamol (ALBUTEROL) 90 mcg, 2 puffs every 4-6 hours as needed, from 06Feb2021 and ongoing, for breathing problems and oral benzonatate 100 mg, thrice daily (100 mg capsules, 1 by mouth three times daily as needed) from 06Feb2021 and ongoing, for cough. On an unspecified date, in Feb2021, the patient developed little sore arm and fatigue. On 01Feb2021, the patient experienced runny nose, nose was a faucet. On 02Feb2021, she had little scratchy throat, cough, sore throat and dizzy spells. On 04Feb2021, she threw up and on 05Feb2021, the patient experienced fever (she had temperature at 102.7 Fahrenheit) and then was hospitalized. Post the vaccination, the patient has been tested for COVID-19 on 05Feb2021 and resulted positive and pneumonia requiring hospitalization. She was admitted on the 05Feb2021 discharged on the 09Feb2021. Chest x-ray and CT chest performed on 05Feb2021 showed pneumonia. Body temperature on 05Feb2021, at night, was 102.8 Fahrenheit. Oxygen saturation (pulse ox) showed the following value: 80s, 84 and 93 on an unspecified date, in Feb2021. Emergency Room Visit and Physician Office Visit required for runny nose, throat irritation, cough, sore throat and pneumonia. Treatment was received for COVID-19 pneumonia, fever, runny nose, throat irritation, cough and sore throat. She was supposed to get the second vaccine on the 18Feb2021. The patient recovered from fever on 07Feb2021, did not recover from dizzy spells, while clinical outcome of the other events was unknown at time of this report.",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,01/28/2021,02/01/2021,4.0,OTH,ALLEGRA; TYLENOL; ALBUTEROL [SALBUTAMOL]; BENZONATATE,,Medical History/Concurrent Conditions: Crohn's disease,,,"['Body temperature', 'COVID-19 pneumonia', 'Chest X-ray', 'Computerised tomogram thorax', 'Cough', 'Dizziness', 'Fatigue', 'Oropharyngeal pain', 'Oxygen saturation', 'Pain in extremity', 'Pyrexia', 'Rhinorrhoea', 'SARS-CoV-2 test', 'Throat irritation', 'Vomiting']",1,PFIZER\BIONTECH,OT 1090220,IN,55.0,F,"extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chills; 1 hr later explosive diarrhea; vomiting; severe joint pain in ankles, knees, hips, elbows; severe headache; This is a spontaneous report from a contactable nurse report for self. A 55-year-old female (not pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular in left arm on 21Feb2021 10:45 AM at single dose for covid-19 immunisation. The patient's medical history was not reported. No COVID prior vaccination. Concomitant medications in two weeks included atorvastatin, aspirin [acetylsalicylic acid], ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. Patient was allergy to morphine. Patient received first dose of bnt162b2 (lot number=EL9263) intramuscular in left arm on 30Jan2021 09:30 AM. On 21Feb2021, 1 hr later patient experienced explosive diarrhea and vomiting 1 time, severe joint pain in ankles, knees, hips, elbows, severe headache. 10 hrs after shot patient had severe chills. Next day joint pain in neck and mouth pain along with severe heart attack. On 23Feb2021 had extreme weakness. No treatment received. Patient was recovered from the events. Nasal Swab Covid test post vaccination on 22Feb2021 was Negative.; Sender's Comments: Based on the limited information provided it is unlikely that heart attack was related to suspect product in this patient on atorvastatin and aspirin. Case will be reassessed when additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/21/2021,02/21/2021,0.0,PVT,ATORVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]; VIT D; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,,,,"['Arthralgia', 'Asthenia', 'Chills', 'Diarrhoea', 'Headache', 'Myocardial infarction', 'Neck pain', 'Oral pain', 'SARS-CoV-2 test', 'Vomiting']",2,PFIZER\BIONTECH,OT 1090221,PA,65.0,F,"Rhabdomyolysis; her CPK was over 2400; Muscle cramps/Muscle spasms; Petechia; Dry skin; Itching; Fatigue extreme/felt tired; Myalgia; Pain; This is a spontaneous report from a contactable Nurse. A 65-year-old female patient received first dose of BNT162B2 (BNT162B2; Lot number EL0140 for both doses, expiry date not reported) via an unspecified route of administration to right deltoid on 23Dec2020 at 15:00 single dose, and second dose via an unspecified route of administration to right deltoid on 13Jan2021 15:15 at single dose for covid-19 immunization, hepatitis a vaccine (HEPATITIS A) intramuscular on 29Dec2020 at single dose for immunization and varicella zoster vaccine rge (cho) (SHINGRIX) intramuscular from 29Dec2020 at single dose for immunization. Medical history included osteoporosis from 2011, osteoarthritis from an unknown date, Knee replacement (Reported due to the osteoarthritis, she had her one knee replaced in 2004 and her other knee replaced in 2011), Spinal compression fracture in 2011 (Reported she fell at work and had a spinal compression fracture in 2011. She said the spinal compression fracture was repaired by a vertebroplasty in 2011) and Hypothyroidism (she has had hypothyroidism for a long time, since either 1998 or 2000). The patient's concomitant medications were not reported. The patient experienced rhabdomyolysis on 06Feb2021, fatigue extreme/felt tired on 30Dec2020, myalgia on 30Dec2020, pain on 30Dec2020, petechia on 06Feb2021, muscle cramps/muscle spasms on 17Feb2021, dry skin on Feb2021, itching on Feb2021 and her cpk was over 2400 on an unspecified date. The patient was hospitalized for rhabdomyolysis from 06Feb2021 to 09Feb2021 and reported to have caused disability. All the other events were reported as medically significant. She said she wanted to report to Pfizer that she was admitted to the hospital on 06Feb2020. She said she was in rhabdomyolysis, and the rhabdomyolysis was really bad. She said she had so much fatigue, myalgia, and pain that she couldn't walk. She said she was given a lot of fluids while she was in the hospital. She said her CPK was over 2400 when she was admitted to the hospital on 06Feb2021. She said she had so much fatigue, myalgia, and pain that she couldn't walk. She said she has a petechia rash, cramps, muscle spasms, dry skin and itching now. Reported she literally saved herself from dialysis by going to the hospital. She said she kept putting off her symptoms, and took Tylenol and Naproxen for the whole month of Jan2021. She said her symptoms started brewing up from day 1, clarifying that her symptoms were not really bad until 30Dec2020 and 31Dec2020. She clarified on 30Dec2020 she took Naproxen, Ibuprofen, and Tylenol for her symptoms, and nothing helped her. She said she knew her symptoms were not normal for her, and she went for the whole month of Jan2021 with her symptoms. She said finally there came a time when she said ""oh no, this is not normal at all"", and she told herself she needed to check in at the hospital. She said she took Naproxen and Tylenol, and felt a little better, and drove herself to the hospital. Reported she kept walking and taking medicines, and while at work she diverted her mind from her symptoms, but when she came home she felt tired, and would tell herself she couldn't do it anymore. She said she doesn't know if what she experienced was from the COVID-19 Vaccine, but that definitely she had a reaction to either the Hepatitis A booster, the Shingrix Vaccine, or the Pfizer COVID-19 Vaccine. Reported she received 11 bags of Normal Saline (1000ml per bag) while she was in the hospital. She said fluid resuscitation was the only way to bring her CPK levels down and to treat the rhabdomyolysis. Reported her symptoms have improved. She said her last CPK was 134 on Wednesday, 17Feb2021. Reported she had cramps and severe muscle spams in her right leg on 17Feb2021, and then had cramps and muscle spasms in her left leg the following day. She said the cramps and muscle spams have not gone away completely. Reported she has a small petechia rash on her lower legs. She said at the moment the petechia rash shows up on her leg, she knows she is going to have a muscle spasm in that area. She said last night she had 2 petechia rashes show up on the lateral side of her right ankle. She said the petechia rash started to burn, and her right leg calf muscle became heavy. She said she could tell her right leg calf muscle was going to start to spasm, so she took some coconut oil and applied the coconut oil to her right leg calf muscle and massaged her right calf muscle. She said she had 2 areas of petechia last night (23Feb2021). She said the first time the petechia was noticed was when she went to the Emergency Room on 06Feb2021. She said the petechia has been persisting since that time. She said prior to being admitted to the hospital she never had dry skin or itching, but now she has dry skin and itching. She said she was using coconut oil to keep her skin moist. She stated she had 2 telehealth calls (11Feb2021 & 18Feb2021) because of a petechia rash and muscle cramps and was asking her doctor is she may need to go back to the hospital. The patient underwent lab tests and procedures which included blood work, CBC and Thyroid level on 06Jan2021 with unknown results (she had regular blood work done for her yearly checkup on 06Jan2021 (BMP, CBC, and Thyroid level). Also included CPK on 06Feb2021 greater than 2400, CPK on 09Feb2021 566 and CPK on 17Feb2021 134 (units were unspecified), She said her last CPK was 134 on Wednesday, 17Feb2021. Therapeutic measures were taken as a result of rhabdomyolysis, fatigue extreme/felt tired, myalgia, pain, muscle cramps/muscle spasms, her CPK was over 2400. Outcome of the event rhabdomyolysis, fatigue extreme/felt tired, myalgia, pain and her cpk was over 2400 was recovering. Outcome of petechia, muscle cramps/muscle spasms, dry skin and itching was not recovered.; Sender's Comments: Based on the information currently available, a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. The Hepatitis A booster and the Shingrix Vaccine may have also played a contributory role. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,3.0,Yes,N,12/23/2020,12/30/2020,7.0,PVT,,,"Medical History/Concurrent Conditions: Hypothyroidism (she has had hypothyroidism for a long time, since either 1998 or 2000.); Knee replacement (she had her one knee replaced in 2004 and her other knee replaced in 2011.); Osteoarthritis; Osteoporosis; Spinal compression fracture",,,"['Blood creatine phosphokinase', 'Blood creatine phosphokinase increased', 'Blood test', 'Dry skin', 'Fatigue', 'Full blood count', 'Muscle spasms', 'Myalgia', 'Pain', 'Petechiae', 'Pruritus', 'Rhabdomyolysis', 'Thyroid function test']",1,PFIZER\BIONTECH, 1090222,MI,20.0,F,"shingles; temporary vision loss; dizziness; Extreme fatigue; body aches; nausea; This is a spontaneous report from a contactable other Healthcare professional (patient herself). This 20-year-old female patient, not pregnant, received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot EL9265,via an unspecified route of administration in the left arm on 03Feb2021 at 02:00 PM (at the age of 20-year old) single dose for COVID-19 immunization. Relevant medical history included suspected allergy to penicillin. Historical vaccine included first dose of BNT162B2, Lot EL3248, on 13Jan2021 at 11:45 AM single dose in the left arm and recombinant human papillomavirus vaccine (GARDASIL) on 15Dec2020 dose 1 in the left arm. Concomitant medication included one a day women's Vitamins. After 2nd dose of vaccine BNT162B2, the patient experienced extreme fatigue, body aches, dizziness, and nausea. She was unable to go into work 2 days after receiving the vaccine due to temporary vision loss because of dizziness. On 21Feb2021 at 9:30 AM, a painful rash on the left side of torso and on spine had shown up. The patient went into her school doctor on 24Feb2021 and was diagnosed with shingles. The patient specified that she have never had this condition before, she was healthy and she did not have any significant stressors. The patient was treated with acyclovir due to the event. The outcome was not recovered for all events. This is a spontaneous report from a contactable Other HCP. This 20-year-old female Other HCP reported herself that: Report about covid vaccine: Yes Reporting type: AE Reporter type: Patient Age group: Adult (18-64 Years) Current age: 20 Current age unit: Years Gender: Female Is pregnant: No Medical qualification reporter: Other Health Professional Covid vaccine details: [{product=COVID 19, brand=Pfizer, lot number=EL9265, lot unknown=False, administration date=03Feb2021, administration time=02:00 PM, vaccine location=Left arm, dose number=2}, {product=COVID 19, brand=Pfizer, lot number=EL3248, lot unknown=False, administration date=13Jan2021, administration time=11:45 AM, vaccine location=Left arm, dose number=1}] Facility type vaccine: Other If other vaccine in fourweeks: Yes Other vaccine 4weeks details: [{other vaccine 4weeks product=Gardasil, other vaccine 4weeks vaccine date =15Dec2020, other vaccine 4weeks dose number =1, other vaccine 4weeks vaccine location=left arm}] Other medications in two weeks: One a day women's Vitamins Adverse event: Extreme fatigue, body aches, dizziness, and nausea following 2nd dose of the vaccine. I was unable to go into work 2 days after receiving the vaccine due to temporary vision loss because of dizziness. On 21Feb2021, a painful rash on the left side of my torso and on my spine had shown up. I went into my school doctor on 24Feb2021 and was diagnosed with shingles. I have never had this condition before, am 20 years old, and am healthy. I do not have any significant stressors. Adverse event start date: 21Feb2021 Adverse event start time: 09:30 AM AE resulted in: [Doctor or other healthcare professional office/clinic visit] If patient recovered: Not recovered If treatment AE: Yes AE treatment: Acyclovir prescription If covid prior vaccination: No If covid tested post vaccination: No Known allergies: suspected allergy to penicillin Other medical history: N/A; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported temporary vision loss together with the reported dizziness and vaccination cannot be excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Blindness transient', 'Dizziness', 'Fatigue', 'Herpes zoster', 'Nausea', 'Pain']",2,PFIZER\BIONTECH, 1090223,,70.0,F,"SV for unstable angina; CAD; Tachycardia; Nausea; Belching; SOB; Chest heaviness, chest pressure, chest tightness; Pain; This is a spontaneous report from a non-contactable other HCP. A 70-year-old female patient received the first dose of bnt162b2 (lot number EN6205) via unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not provided. Upon 15 minutes after injection, she noted nausea with belching and had some SOB. Symptoms worsened as she ambulated over to the medical bay along with her chest pressure. She denied rash, hives, welts, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient reported recently admitted for unstable angina and CAD with tachycardia. Patient had elevated d-dimer and blood clot was ruled out. Patient discontinued on new medication, beta blocker. Since discharge this Sunday 21Feb2021, she reported chest heaviness as if she has ""cardboard on chest."" Can slightly increase with going up and down stairs or increased activity. She states she had reached out to her cardiologist via an online site but has not heard back. Patient stated her pain is about the same today. Patient complains of chest tightness and shortness of breath. The outcome of events was unknown. No Follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of events unstable angina and tachycardia cannot be excluded. The patient's age and suspected cardiac condition are risk factors. The event CAD, given its progressive nature, is most likely an underlying condition, thus unrelated to the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,"['Angina unstable', 'Chest discomfort', 'Coronary artery disease', 'Dyspnoea', 'Eructation', 'Fibrin D dimer', 'Nausea', 'Pain', 'Tachycardia']",1,PFIZER\BIONTECH, 1090224,OK,70.0,F,"Muscle pain; Headache; Having issues breathing; could not swallow; Muscle tightness in right jaw, mouth, neck, shoulder; Muscle type convulsions in neck, shoulder, arms and upper chest; This is a spontaneous report from a contactable consumer reported for self. This 70-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via intramuscular on 24Feb2021 at 10:00 AM at single dose in left arm in a pharmacy or drug store for COVID-19 immunization. The patient's medical history included high blood pressure. The patient had known allergies: anabolic steroids, many antibiotics. The patient did not have COVID prior vaccination. The patient's concomitant medications included hydrochlorothiazide, triamterene (MAXZIDE) and vitamins. At 24Feb2021 at 10:00 PM, the patient experienced muscles in neck, jaws and throat started clinching up and she could not swallow. The patient began having issues breathing. The patient was advised to go to emergency room (ER). At ER, patient started with muscle type convulsions in neck, shoulder, arms and upper chest. The patient had several episodes. Doctor administered diphenhydramine hydrochloride (BENADRYL) intravenously, did blood and urine workup. After 4 hours the shaking stopped, and the muscle contractions lessened. The patient was sent home. Next day 25Feb2021, she still had some residual muscle tightness in right jaw, mouth, neck, shoulder. On third day 26Feb2021, she had light shaking of hands and arms. The patient was still taking 25 mg diphenhydramine hydrochloride every 8 hours. She added ibuprofen (ADVIL) because she also had muscle pain and headache. The patient was recovering from the events. The patient did not test COVID post vaccination. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/24/2021,02/24/2021,0.0,PHM,MAXZIDE,,Medical History/Concurrent Conditions: Allergy to antibiotic; Blood pressure high; Drug allergy,,,"['Blood test', 'Dysphagia', 'Dyspnoea', 'Headache', 'Muscle tightness', 'Myalgia', 'Seizure', 'Urine analysis']",UNK,PFIZER\BIONTECH, 1090225,MI,35.0,F,"was going to pass out/Loss of consciousness; was going to pass out/Loss of consciousness/hx of passing out remote in distant past; started to feel very strange/No hearing or vision loss, just a general strange and uncomfortable feeling.; deep dreaming, then awoke feeling poorly; deep dreaming, then awoke feeling poorly; shaking; chills; BNT162B2 used in a Breastfeeding Mother; BNT162B2 used in a Breastfeeding Mother; This is a spontaneous report from a contactable physician (patient), this physician reported information for both mother and fetus/baby. This is the maternal report. Only this case is serious. A 35-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular into left arm on 05Feb2021 09:00 at single dose for COVID-19 immunization in workplace clinic. Medical history included hx of passing out remote in distant past. No allergies to medications, food, or other products. concomitant medications were none (no other medications the patient received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient previously took the first dose of BNT162B2 on unspecified date at single dose for covid-19 immunization. About 17 hours after vaccine, at 3am (06Feb2021 03:00), while up feeding her infant and sitting in a chair in the dark, she started to feel very strange, kind of like she was going to pass out (hx of passing out remote in distant past). No hearing or vision loss, just a general strange and uncomfortable feeling. Tried to call for help. Lost consciousness for a few seconds and had deep dreaming, then awoke feeling poorly. Set child back to bed, went to bed myself, had shaking chills for maybe 30 minutes following. No sweats, no normal symptoms related to vasovagal syncope. Just a general uncomfortable strange sensation as the prodrome. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the events. Patient was recovered from the events on unspecified date. It was reported as non-serious report. Seriousness criteria results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect were all no. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, the Company considers the reported event loss of consciousness recurrence is unrelated to BNT162B2 vaccine but more likely an inter-current medical condition in this subject with medical history of passing out remote in distant past. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021240721 mother/baby case",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/05/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Loss of consciousness,,,"['Abnormal dreams', 'Asthenia', 'Chills', 'Disease recurrence', 'Feeling abnormal', 'Loss of consciousness', 'Off label use', 'Product use issue', 'Tremor']",2,PFIZER\BIONTECH,OT 1090226,,76.0,F,"nauseated; feeling weak and not well; feeling weak and not well; allergic to an ingredient in the vaccine: polyethylene glycol; rectal bleeding which then became rectal hemorrhage; stomach cramps; bowel movements; diarrhea; This is a spontaneous report from a contactable consumer. A 76 years old female consumer reported that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on the 12Feb2021 at around 04:30PM single dose for COVID-19 immunisation. Medical history and concomitant drugs were not provided. At midnight that same day on 12Feb2021, she started getting stomach cramps, bowel movements, diarrhea, rectal bleeding which then became rectal hemorrhage. She did not go to the hospital. She said the effects dissipated; however, she still felt nauseated today (26Feb2021). The patient was currently taking ondansetron (ZOFRAN). She has been feeling weak and not well. She had a colonoscopy planned soon. She's concerned about receiving the second dose. She mentioned as well that she believed she was allergic to an ingredient in the vaccine: ""polyethylene glycol"". Outcome of nausea was not recovered. Outcome of other events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/12/2021,0.0,UNK,,,,,,"['Abdominal pain upper', 'Allergic reaction to excipient', 'Asthenia', 'Bowel movement irregularity', 'Diarrhoea', 'Malaise', 'Nausea', 'Rectal haemorrhage']",1,PFIZER\BIONTECH, 1090227,MA,73.0,F,"Lightheaded/Dizziness within a few minutes of injection; This is spontaneous report from a contactable healthcare professional. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EN6205, unknown expiration), intramuscular in right arm on 26Feb2021 12:00 PM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced lightheaded/dizziness within a few minutes of injection on 26Feb2021 at 12:00 PM. The event resulted in emergency room/department or urgent care visit. The patient received unspecified treatment for the event following evaluation/transport to hospital. It was unknown if the patient received other vaccine in four weeks. It was unknown if patient had COVID prior to vaccination and if tested for COVID post vaccination. Outcome of the event was unknown. The event was assessed as serious (hospitalization). No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for event dizziness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/26/2021,02/26/2021,0.0,OTH,,,,,,['Dizziness'],1,PFIZER\BIONTECH,OT 1090229,MI,63.0,F,"pulmonary embolism/Blood clots in the lung; heart attack; Shortness of breath; headache; jaw hurt; Shin hurt; heart burn; This is a spontaneous report from a contactable consumer (patient's son). A 63-year-old female patient (mom) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration in arm in Feb2021 (reported as in the first week of Feb2021) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 in Jan2021 for COVID-19 immunization. Reporter (patient's son) received his first dose of Pfizer COVID vaccine on Wednesday and wanted to know if this vaccine could cause blood clot. He stated his mom (patient) in the hospital due to pulmonary embolism from 24Feb2021, 2.5 weeks after her second shot. He stated his anxiety levels were higher than normal. He had strong response to flu vaccine this year and experienced chill, shakes, fever, received antibiotic, and loss sense of taste from the flu vaccine. Reporter read online that some people commented that they have DVTs (deep vein thrombosis) and blood clots from the Pfizer COVID vaccine. Patient experienced blood clots in the lung in Feb2021 and hospitalized on 24Feb2021. Patient got her second shot about 2 weeks before and she ended up in the hospital with pulmonary embolism. They looked at her lungs and found all the blood clots. Patient had really bad shortness of breath, headache, her jaw hurt, and her shin hurt. She was helping out at vaccine clinic and she was out of breath, she said the old people in strollers were passing her. Patient began to make complaints about how she was feeling in mid of Feb2021. Patient said in rare cases 2 weeks after the second dose reactions could happen. Patient got done working in ICU, and helped with PPE, then at 11 she left work at the hospital, she was experiencing heart burn for 3 days and so she thought had a heart attack drove to an ER (emergency room) on the way home, and then was admitted to the hospital on that same day 24Feb2021, she was supposed to be discharged today (26Feb2021). Patient had been feeling out of breath for past 2 month, it was possible it might seem like it was related to the vaccine but it could also not be related. Reporter stated that on the internet he saw how a 1000 deaths happened after the vaccine, it was all old people, but in the autopsies there was no link to the vaccine, they were going to die regardless. Lab data included: She did get a test before for Factor 5 Leiden but it was negative. They did test for COVID, it was negative, while in the hospital. In the hospital they were also testing her again for the Factor 5 Leiden, the results hadn't come back yet. They did test for blood clots, they did an MRI (magnetic resonance imaging) in Feb2021, it was positive for blood clots (blood clots in the lungs). When she was admitted her oxygen was 85%. Outcome of the events was unknown. Information on lot and batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,,,,,"['Blood test', 'Dyspepsia', 'Dyspnoea', 'Headache', 'Magnetic resonance imaging', 'Myocardial infarction', 'Oxygen saturation', 'Pain in extremity', 'Pain in jaw', 'Pulmonary embolism', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1090230,,35.0,F,"lightheadedness/dizziness; Vaccine-Related Anxiety; This is a spontaneous report from a non-contactable healthcare professional. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. During her 30-minute waiting period after the injection, the patient began to experience lightheadedness and dizziness. Treatment included water and snacks. Follow-up response to treatment was excellent. Patient discharged (pending clarification), she was stable to go home and follow-up with PCP. Differential diagnosis reported as vaccine-related anxiety (include misc mental health) and systemic reaction (hypoglycemia, hypotension, generalized rash). Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,"['Anxiety disorder', 'Dizziness']",1,PFIZER\BIONTECH, 1090232,CA,64.0,F,"Right eye on right side of cornea is completely red. It looks like a broken blood vessel. There was no trauma associated with this.; This is a spontaneous report from a contactable consumer (patient herself). This 64-year old female patient, not pregnant, received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EN6203), via unspecified route of administration on the left arm on 23Feb2021 at 01:00 PM (at the age of 64-year old) at single dose for COVID-19 immunization at Doctor's office/urgent care. Relevant medical history included allergy to codeine. Concomitant medications were not reported. On 25Feb2021 at 12:00 AM the patient noticed that right eye on right side of cornea was completely red. It looked like a broken blood vessel. There was no trauma associated with this. The patient did not receive any treatment due to the event. The patient was not recovered from the event.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/25/2021,2.0,OTH,,,,,,['Eye haemorrhage'],1,PFIZER\BIONTECH, 1090233,NC,33.0,M,"Felt intense itching on face; Developed alopecia barbae approximately 1 week from second dose/subsequent hair loss has remained permanent since; This is a spontaneous report from a contactable physician. A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142), via an unspecified route of administration on 09Jan2021 14:00 at a single dose on left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: K5730), on 19Dec2021 at 02:00 PM, on right arm, for COVID-19 immunization. The patient experienced developed alopecia barbae in Jan2021 approximately 1 week from second dose. After the shot (24h) the patient felt intense itching on face on 10Jan2021; subsequent hair loss has remained permanent since. The event alopecia barbae was reported to have resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No treatment was given for the events. The outcome of the events was not recovered. The patient did not have COVID prior vaccination and was not COVID tested post vaccination.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/09/2021,01/01/2021,,PVT,,,,,,"['Alopecia areata', 'Pruritus']",2,PFIZER\BIONTECH, 1090234,NJ,44.0,F,"Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored stools; Very faint/thought she was going to pass out; Eyes were watering; blotches on her neck and chest; tingly experience on her tongue and lips; Severely shaking; Overwhelming chills; Extreme nausea; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: E19266) via intramuscular at single dose on 20Feb2021 09:30 for COVID-19 immunization. The first dose was on 30Jan2021 in left arm. Medical history included splenectomy from Feb2017; pancreatic surgery from Feb2017, they removed her spleen as part of that; soy allergy; poultry allergy. Patient confirmed she had splenectomy. The surgery was sort of emergency based so knowing most likely they were taking her spleen out; she was given 4 vaccinations. In the hospital, she did break out in what appeared to be like a chicken pox type rash. The rash lasted a month and then it started to fade. She did not have any breathing sort of symptoms. The doctors did attribute the rash to one of the vaccinations, she was not clear on what vaccine caused the reaction. Ideally, she was supposed to have 2 weeks prior to the surgery so her body had time to reabsorb but she did not have that kind of time, but she had nothing internally going on. She confirmed she had no names, NDC, Lot number or expiration dates for the vaccines she received at that point in time. Having the splenectomy was the biggest thing. In the past, she did not have any allergies to medications, but did have allergies to soy and poultry. She did break out from certain food and her skin develops those blotches. She did have an extra work up in Feb2020, where they tested a bunch of food sensitivities and allergies, and nothing came back. This was right before COVID hit so she did not really follow back up after that, but she was tested for all major foods and household things and nothing came up. In her late 20's, she definitely tested for a soy allergy and allergy to poultry. She did check off yes, she had a reaction previously when she was filling out the form at the COVID-19 vaccine site knowing that she had this prior experience. She was held 30 minutes each time for that reason. Concomitant medication was none. Prior vaccinations (within 4 weeks) was no. On 20Feb2021, patient was very faint, thought she was going to pass out, eyes were watering, blotches on her neck and chest, tingly experience on her tongue and lips, severely shaking, overwhelming chills, extreme nausea. On an unspecified date, patient experienced headache, general weakness, in her legs especially, no energy, no appetite, chills that come and go, diarrhea and green colored stools. Patient received her second shot of Pfizer's vaccine on 20Feb2021. She had had symptoms ever since. She had a reaction on site at the vaccine center. She eventually had to go to the Emergency Room by ambulance. Her symptoms were still going on and tomorrow would mark a week since she received the second dose. The symptoms she experienced on site were different than what she was currently experiencing. She felt like she had a true reaction at the vaccine facility site. Within 6 minutes of receiving the second vaccine, she became very faint, her eyes were watering. She thought she was going to pass out for a bit. She was told she had blotches on her neck and chest. She had a tingly experience on her tongue and lips. She was severely shaking and had overwhelming chills. She stated this happened for a couple of hours. Basically, there were 3 waves of these symptoms kind of happening. The third wave happened probably a couple hours after receiving the vaccine. At that point, she had been given two pills of diphenhydramine hydrochloride (BENADRYL), taken orally. With the third wave, she thought she was going to pass out, which she thought multiple times before, but then with this particular wave, she experienced extreme nausea which was kind of a new symptom. The doctor on site said to the EMT that he wanted her to go to the Emergency Room. Patient confirmed she was taken to the ER via ambulance the day she received the vaccine, 20Feb2021. She was never admitted into the hospital; she was only seen in the Emergency Room for a couple of hours. She was given IV fluids, she had blood work done. She didn't have a copy of her labs but she was told they were okay. She was injected with diphenhydramine hydrochloride (BENADRYL) via IV before she was released. A lot more symptoms came after she was released from the hospital (ER). She came home and she had just a crazy headache that she really woke up with every single day until this morning. She had been taking a lot of caffeine/paracetamol (EXCEDRIN, Lot#: H044G, Expiry Date: Jun2022) for her headaches. She experienced extreme weakness, nausea. She clarified she had weakness in her legs. She had this exhaustion, and she felt this general weakness sort of in her legs especially. She was still taking stuff for a headache, and she was taking nausea pills. She had been out of work all week. She had no energy, no appetite really. She had chills that come and go. She had diarrhea. She clarified she had more diarrhea in the beginning days after receiving the vaccine, but it was always been a green colored stool as well. The ER called and checked in and were very surprised she had been having the symptoms still so severely. They wanted her to go get an actual COVID test. She went to the Urgent Care to get COVID tested on 23Feb2021 and had a rapid and PCR test. The rapid test came back negative. She had not received the results for the PCR test yet. She was taking diphenhydramine hydrochloride but she stopped taking that. The hospital directed her stop taking the diphenhydramine hydrochloride earlier in the week. She clarified she was taking a generic version (Lot#: P113966, Expiry Date: Feb2021), coated mini tablets. She clarified the nausea pills she had been taking was the generic for ZOFRAN, ondansetron 4 mg tablet, by mouth, every 8 hours. She confirmed this product was dispensed in a pharmacy bottle with no NDC, Lot number or expiry date on it. She clarified she also had been taking the generic version of TYLENOL EXTRA STRENGTH, it was the Up and Up Brand acetaminophen (Lot#: P122699, Expiry Date: Nov2022) gel caps, 500mg. COVID-19 rapid test was negative on 23Feb2021; COVID-19 PCR test on 23Feb2021 was unknown results. Patient asked if there was a hotline she can call or an information number where she can talk to somebody about her symptoms. She also reported this to her doctor but the doctor made it clear since it was a private practice, they had limited information. The doctor did take down similar information, she just did not know if there was any further information or a hotline she could call. The outcome of events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/20/2021,02/20/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Food allergy; Soy allergy; Splenectomy; Whipple's operation,,,"['Asthenia', 'Blood test', 'Chills', 'Decreased appetite', 'Diarrhoea', 'Faeces discoloured', 'Headache', 'Lacrimation increased', 'Muscular weakness', 'Nausea', 'Paraesthesia oral', 'Presyncope', 'Rash macular', 'SARS-CoV-2 test', 'Tremor']",2,PFIZER\BIONTECH,OT 1090235,OR,68.0,F,"She still has fatigue; The extreme pain, mental fog, and disconnect that came with it has all subsided; The extreme pain, mental fog, and disconnect that came with it has all subsided; Cytokine storm; extreme chills with teeth chattering; This is a spontaneous report from contactable consumer. A 68-year-old female patient the second dose of BNT162B2 (Batch/lot number: EN5318) on 04Feb2021 at 1:00 on Left arm for covid-19 immunization. Medical history was ongoing Arachnoiditis (this is a spinal cord disease). Concomitant drugs were not reported. Historical Vaccine was 1st dose of BNT162B2 (Lot Number: EL1283) on 15Jan2021 administered in left arm for covid-19 immunization. She was calling to report a severe reaction that occurred after the second injection. On 05Feb2021 she started to have extreme chills with teeth chattering at 3 AM. She knew this could be part of the symptoms. At 6 AM on 05Feb2021 she got up and with her husband's assessment who is also is a doctor it was determined by her husband she was in a cytokine storm that attacked her spinal cord disease. The extreme chills ended within a couple of hours on 05Feb2021. The cytokine storm has pretty much resolved. It is still there, but better. She still has fatigue. However, the extreme pain, mental fog, and disconnect that came with it has all subsided. Caller stated she knows from research and talking to other people most people might have the chills after the COVID Vaccine. The chills is not the severe side effect she is referencing as severe. The Cytokine storm reaction for her wit her spinal cord disease is unexpected and not normal. This was the severe event. No Emergency Room visited. Physician's Office visited for Cytokine Storm. She should have gone to the hospital, but she did not want to go. Seven days after event started, she went to her physician. This was as soon as she was able to get up and get out of the house. Treatment was mainly self-treating. Her husband is a doctor and they did what they needed to do at home. These side effects were pretty horrific. Outcome of the event cytokine storm was recovering, for fatigue was not recovered, for other events was recovered. No follow-up attempts are possible. No further information expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/05/2021,1.0,PVT,,Arachnoiditis,,,,"['Chills', 'Cytokine storm', 'Fatigue', 'Feeling abnormal', 'Pain']",2,PFIZER\BIONTECH, 1090236,NY,38.0,M,"It is the ringing in the ear; felt like a siren was going both of his ears; Headache; His arm was hurting; Throwing up; losing his balance; He was running a temperature; This is a spontaneous report from a contactable consumer. This consumer reported that a 38-year-old male patient (son) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for Covid-19 immunization on 19Feb2021. Relevant history and concomitant drugs were unknown. Relevant concomitant drugs were unknown. The patient previously received the first dose of BNT162B2 in 05Feb2021 for Covid-19 immunization on, when he received the first one he felt headache a little bit and his arm was hurting and all of a sudden he suffered from tinnitus in his ear. He had lost 8 pounds in like 4 days since he got that shot. He weighs not like a 117-118 pounds. When he received the second shot he experienced headache, tinnitus in his ears, which became so worse that he felt like a siren was going both of his ears and he landed up in the hospital plus he was throwing up and he was losing his balance and he was running a temperature and he was still in the hospital. It was the ringing in the ear; felt like a siren was going both of his ears. His arm was hurting. He was in the hospital since Tuesday and ringing in his ear, it would not stop. He said it was started, he always had this but not to this extent he started after the first vaccine that he had. He wanted to know because his ear nose and throat doctor said that another patient had the same reaction (Further clarification was unknown, hence split was not captured) and he wanted to know why is that not listed on the reactions. The outcome of events tinnitus and throwing up was not resolved. Outcome of other events was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/19/2021,02/01/2021,,UNK,,,,,,"['Balance disorder', 'Body temperature', 'Body temperature increased', 'Headache', 'Pain in extremity', 'Tinnitus', 'Vomiting']",2,PFIZER\BIONTECH, 1090237,MA,,M,"voice hoarseness; throat clearing; This is a spontaneous report from Pfizer-sponsored program from a contactable consumer (patient). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 24Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the vaccine on Wednesday (24Feb2021) and after getting the first dose he was experiencing voice hoarseness and throat clearing in 2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/24/2021,,,UNK,,,,,,"['Dysphonia', 'Throat clearing']",1,PFIZER\BIONTECH, 1090238,MA,,F,"back pain; Muscles hurt in her back; Fatique; This is a spontaneous report from a Pfizer Sponsored Program . A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced back pain, muscles hurt in her back, fatigue on an unspecified date. The outcome of events wsa unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Back pain', 'Fatigue', 'Myalgia']",1,PFIZER\BIONTECH, 1090239,OK,82.0,F,"she passed away on 19Feb as she had a HGB of 5; O2 sats were in 70s; she had a HGB of 5; on the same side the patient hand started swelling; lymphedema from L breast; swelling all over; This is a spontaneous report from a contactable consumer reporting on behalf of the mother. An 82-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 at 13:45, at single dose, in left arm, for COVID-19 immunization. No other vaccine was given in four weeks. Medical history included chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). Known allergies: none. The patient had no COVID prior vaccination and was not tested after vaccination. Concomitant medications were not reported, however, the patient received other medications in two weeks. On 05Feb2021 at 09:00, on the same side the patient hand started swelling and doctor gave her some furosemide (LASIX). One week from vaccination she started having lymphedema from L breast and started noticeably swelling all over. On 18Feb2021 she was taken to the hospital as O2 sats were in 70s. She passed away on 19Feb2021 as she had a HGB of 5. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization for 1 day. No treatment was received. No autopsy was performed. Low oxygen saturation, hand swelling, lymphedema from L breast and swelling all over final outcome was unknown. Information on Lot/Batch number has been requested.; Reported Cause(s) of Death: she passed away on 19Feb as she had a HGB of 5; she had a HGB of 5",Yes,02/19/2021,Not Reported,Yes,1.0,Not Reported,N,02/03/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Congestive heart failure; COPD,,,"['Death', 'Haemoglobin', 'Haemoglobin decreased', 'Lymphoedema', 'Oxygen saturation', 'Oxygen saturation decreased', 'Peripheral swelling', 'Swelling']",UNK,PFIZER\BIONTECH, 1090240,NY,71.0,M,"Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus",Yes,03/04/2021,Not Reported,Yes,18.0,Not Reported,N,02/10/2021,02/01/2021,,PVT,,,Medical History/Concurrent Conditions: Cataract extraction; Rotator cuff repair,,,"['Blood pressure measurement', 'Body temperature', 'COVID-19 pneumonia', 'Cardiac arrest', 'Chest X-ray', 'Decreased appetite', 'Dehydration', 'Heart rate', 'Hypotension', 'Hypoxia', 'Investigation', 'Oxygen saturation', 'Physical examination', 'Pulmonary embolism', 'Pyrexia', 'Renal failure', 'Respiratory arrest', 'Respiratory failure', 'SARS-CoV-2 test', 'Thrombosis', 'Ventricular tachycardia']",1,PFIZER\BIONTECH, 1090265,SC,,M,"Subcutaneous injection; A spontaneous report was received on 23 Feb 2021 from a healthcare professional for a male patient of an unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and it was given incorrect via subcutaneous as oppose to intramuscular The patient's medical history was not provided. No concomitant product use was reported. On 22 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) subcutaneously for prophylaxis of COVID-19 infection. The patient's skin was pinched, and vaccine was injected subcutaneously as oppose to intramuscularly. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, incorrect subcutaneous vaccine shot as oppose to intramuscular, was considered resolved on 22 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Incorrect route of product administration'],1,MODERNA,OT 1090266,NC,88.0,M,"had a positive Covid test; had a positive Covid test; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that that an 88-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration, on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to receiving BNT162B2. Medical history and concomitant medications were none. The consumer reported that her husband is due to have his second Pfizer vaccine on 10Feb2021, but he just had a positive Covid test on 06Feb2021. He tested positive after receiving the first dose of the vaccine. She asked if he still can get the second dose of the vaccine. The patient has kept in touch with his doctor while he has been recuperating. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,02/06/2021,17.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1090267,MO,,M,"he has experienced tingling sensation in his fingertips and his nails; weakness in his arms; This is a spontaneous report from a Contactable consumer. A male consumer (patient) of an unspecified age received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247 and Expiry date: Unknown), via an unspecified route of administration from 27Jan2021 as a SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Nov2020. By 02Dec2020 he was fine and back to work. The patient's concomitant medications were not reported. The patient experienced tingling sensation in his fingertips and his nails on 28Jan2021 with outcome of unknown and, weakness in his arms on 28Jan2021 with outcome of unknown. He says it takes extra effort to move his arms.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/28/2021,1.0,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Muscular weakness', 'Paraesthesia']",1,PFIZER\BIONTECH, 1090268,,,F,"Nausea; dry heaving; Temp climbed to102/ Fever broke at 630 am; chills came on; body aches; This is a spontaneous report from a non-contactable consumer. This 59-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) , via an unspecified route of administration on unspecified date at 4:00PM at single dose for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that temperature started at 11:30, ""temp climbed to102 and fever broke at 06:30AM with Tylenol"" (onset date not reported) with outcome of recovered, then chills came on on an unspecified date with outcome of unknown. The patient also continued having body aches on an unspecified date with outcome of not recovered, dry heaving on an unspecified date with outcome of not recovered and nausea on an unspecified date with outcome of unknown. Her doctor prescribed Zofran because the nausea and dry heaving was awful. The patient stated she was ""down in bed for 2 days and missed 2 days of work"". Lab tests and procedures included body temperature of 102 (no units provided) on unknown date. Therapeutic measures were taken as a result of ""temp climbed to102/ fever broke at 6:30 AM, dry heaving and nausea. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Body temperature', 'Chills', 'Nausea', 'Pain', 'Pyrexia', 'Retching']",UNK,PFIZER\BIONTECH, 1090269,FL,84.0,M,"arm soreness 2nd shot; This is a spontaneous report received from a contactable consumer (patient). An 84-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9243), via an unspecified route of administration on 02Feb2021 at the age of 84-year-old in Left Arm at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 84 years old on 12Jan2021 for Covid-19 immunization and the following morning on 13Jan2021, he experienced headache and loose stools/ had really loose stool and was squirting liquid/diarrhea. The patient experienced arm soreness on an unspecified date which the patient was admitted to hospital. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021050412 Same patient/drug, different dose",Not Reported,,Not Reported,Yes,,Not Reported,U,02/02/2021,,,UNK,,,,,,['Pain in extremity'],2,PFIZER\BIONTECH, 1090322,CA,71.0,F,"MY WIFE DIED UNEXPECTEDLY 4 DAYS AFTER HER SECOND DOSAGE SHOT, ON FEBRUARY 17, 2021. SHE HAD BEEN HEALTHY AND HAD A RECENT CHECKUP AT WHICH THE DOCTOR GAVE HER A CLEAN BILL OF HEALTH. SHE WAS ALERT AND IN GOOD SPIRITS JUST THE NIGHT BEFORE WHEN WE WATCHED A MOVIE TOGETHER. I SAW NO INDICATION THAT SHE WAS FEELING POORLY OR OTHERWISE. I FOUND HER IN BED, DECEASED, UPON COMING HOME FROM WORK THE NEXT DAY.",Yes,02/17/2021,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/17/2021,4.0,OTH,"Supplements: Krill Oil, turmeric Curcumin, Lecithin, Multivitamin; Alergy (antihistamine)",None,None,,None,['Death'],2,PFIZER\BIONTECH,IM 1090343,OR,31.0,M,"ITP relapse - platelet drop >10,000 which lead to petechia, bleeding gums, bruising easily.",Not Reported,,Yes,Not Reported,,Not Reported,N,03/07/2021,03/09/2021,2.0,OTH,,,Chronic ITP,,,"['Blood test abnormal', 'Condition aggravated', 'Gingival bleeding', 'Immune thrombocytopenia', 'Increased tendency to bruise', 'Petechiae', 'Platelet count decreased']",2,MODERNA,SYR 1090369,SC,82.0,F,"Patient showed reaction to vaccine almost immediately, began having chills and nausea. Patient ultimately succumbed to cardiac arrest.",Yes,02/25/2021,Not Reported,Not Reported,,Not Reported,N,02/24/2021,02/24/2021,0.0,UNK,,No,No,,Penicillin,"['Cardiac arrest', 'Chills', 'Death', 'Nausea']",2,MODERNA,SYR 1090408,IL,37.0,F,"anaphylactic reaction; Sweating; Slow hands movement; nausea; Body aches; A spontaneous report was received from a consumer who was a 37-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, sweating, body aches and anaphylactic reaction. The patient's medical history included a previous anaphylactic reaction to her first Moderna Covid-19 vaccine. .Concomitant medications were not reported. On 30-DEC-2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) and on 27-JAN-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection. On 27-JAN-2021, after receiving the second dose of mRNA-1273, the patient reported that she experienced nausea, sweating, body aches, and an anaphylactic reaction that was characterized by slow hand movements and facial swelling. The patient reported that she would see her doctor on 18-Feb-2021. Treatment for the events were not reported. The patient received both doses of mRNA-1273, therefore, action taken with the drug was not applicable. The outcomes of the events, nausea, sweating, body aches and anaphylactic reaction, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Yes,Not Reported,,Not Reported,U,12/30/2020,01/27/2021,28.0,UNK,,,Medical History/Concurrent Conditions: Anaphylaxis (Patient reported having anaphylaxis two weeks after her first Moderna vaccine dose. She received it on 30-Dec-2020.),,,"['Anaphylactic reaction', 'Bradykinesia', 'Hyperhidrosis', 'Myalgia', 'Nausea']",1,MODERNA,OT 1090409,,,U,"A few drops of the vaccine leaked out; A few drops of the vaccine leaked out; A spontaneous report was received from a nurse concerning a patient of unknown age and gender, who received the first dose of the Moderna's COVID-19 vaccine (mRNA-1273) and a few drops of the vaccine leaked out The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient received the first of two planned doses of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection and a few drops of the vaccine leaked out (accidental underdose). No AEs were reported, and no treatment medications were reported. Action taken with mRNA-1273 was not reported. The outcome of the event was considered recovered.; Reporter's Comments: This report refers to a case of accidental underdose and vaccination site discharge for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Accidental underdose', 'Vaccination site discharge']",1,MODERNA,OT 1090410,WI,,M,"Broken Hip; Fall; A report was received from a consumer who was also a 73-year old, male patient who had a fall and broke his hip. The patient's medical history was not provided. No relevant concomitant medications were reported. On 25 JAN 2021, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 20 FEB 2021 the patient had a fall and broke his hip. The patient received surgery to repair the injury and was prescribed pain medications. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of fall, a causal relationship cannot be excluded and the event of hip fracture is assessed as unlikely related to mRNA-1273.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,02/20/2021,26.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Fall', 'Hip fracture']",1,MODERNA,OT 1090411,,,M,"3rd dose 28 days after the 2nd one; A spontaneous report was received from a healthcare professional concerning an male patient of an unknown age (approximately 60+ years old), received third dose of Moderna's COVID-19 vaccine (mRNA-1273) vaccine by mistake (extra dose administered). (Case crosslinked to MOD21-037355, MOD21-037502, MOD21-037503, MOD21-037495). No Adverse events were reported. The patient's medical history was not provided and concomitant medications were also not provided. On 22 Feb 2021, the patient received their third dose of mRNA-1273 (Lot/batch: unknown) through unknown route of administration for prophylaxis of COVID-19 infection. The third dose was given 28 days after the second one, which had also been given 28 days after the first dose (extra dose administered). No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event third dose was given 28 days after the second one was considered recovered on 22 Feb 2021.; Reporter's Comments: This report refers to a case of Extra dose administered for mRNA-1273, lot #unknown, with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Adverse event (No reported medical history),,,['Extra dose administered'],3,MODERNA,OT 1090412,NY,88.0,F,"Activated a BAKERS SYSTS; she could not get up, she could not go to bathroom; Left leg was very sore; Left leg very swollen; Chills; Had fever; Inconsistencies to remember; Not feel well; Delirious; A spontaneous report was received from a consumer concerning 88-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bad reaction, began to not feel well, had fever, was delirious, inconsistencies with speech, problems with the left leg, left leg was very sore, very swollen, could not get up, had chills, couldn't sit in the bathroom, overreaction and activated a Baker's cyst The patient's medical history was not provided. No relevant concomitant medications were reported. On 16 Feb 2021, approximately three hours prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient experienced to not feel well, had fever, was delirious(considered medically significant event), inconsistencies to remember, problems with the left leg. On Wednesday 17 Feb 2021, the patient experienced left leg was very sore, very swollen, could not get up, could not go to the bathroom, had a fever and chills. On Thursday 18 Feb 2021, the patient experienced could not sit in the bathroom. On Friday 19 Feb 2021, the patient was still very swollen. On an unknown date, the patient experienced activated a BAKERS SYSTS Laboratory details included, on Saturday 20 Feb 2021, the patient went to the hospital and got an ECO DOPPLER. Treatment for the event included Ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, bad reaction, began to not feel well, she had a fever, she was delirious, said inconsistencies, problems with the left leg, left leg was very sore, very swollen, could not get up, could not go to the bathroom, had a fever and chills, couldn't sit in the bathroom, overreaction and activated a BAKERS SYSTS was considered recovering(getting better every day).; Reporter's Comments: Based on the current available information and a temporal association between the use of the product and the start date of the event and excluding all other etiologies, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/16/2021,02/16/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No Medical History Reported),,,"['Chills', 'Delirium', 'Gait inability', 'Malaise', 'Memory impairment', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Synovial cyst', 'Ultrasound Doppler']",2,MODERNA,OT 1090417,OH,93.0,M,Error: Wrong Dose of Vaccine - Too High,Yes,03/08/2021,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/06/2021,0.0,PHM,,,,,,['Incorrect dose administered'],3,PFIZER\BIONTECH,IM 1090434,,35.0,F,Moderna COVID-19 Vaccine EUA Swollen and painful lymph nodes in armpit of the same arm I received injection.,Not Reported,,Not Reported,Not Reported,,Not Reported,,03/02/2021,03/08/2021,6.0,PHM,,,,"Tdap, 2 years old, lost ability to walk for several hours",,"['Lymph node pain', 'Lymphadenopathy']",1,MODERNA, 1090464,TN,73.0,M,"Feb. 10: Moderna Vaccination #1 Administered (arm) Feb. 11-Feb. 19: Developed a cough which worsened, weakness, confusion, could not follow instruction, fell, no appetite, fever of 102.8 on Feb. 19, no taste Feb. 20: Emergency Room with diagnosis of Covid pneumonia. Given usual Covid treatment. Became very confused, combatative, etc. Feb. 21: Placed on ventilator Mar. 1: Ventilator removed. Patient expired.",Yes,03/01/2021,Not Reported,Yes,10.0,Not Reported,N,02/10/2021,02/11/2021,1.0,PUB,"Protonix, Crestor, Aspirin, Metroprolol, Wellbuterin, Grapentin, Clonazepam","Heart disease, Hyperlipidemia, Low B/P, Insomnia, one kidney (had donated one), Auto immune disease, Anxiety, Depression, some incontinence possibly due to enlarged prostate, Hydrocele, Morton's neuromas, poor circulation, ?GERD",All the above.,,?,"['Ageusia', 'Aggression', 'Asthenia', 'Blood test', 'COVID-19 pneumonia', 'Chest X-ray', 'Computerised tomogram thorax', 'Confusional state', 'Cough', 'Death', 'Decreased appetite', 'Fall', 'Mechanical ventilation', 'Pyrexia']",1,MODERNA,IM 1090477,FL,69.0,F,"flu-like symptoms; fever; chills; aches/pains; vomiting; abdominal pain -feels like severe case of the flu; This is a spontaneous report from a contactable nurse reported for self. This 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL9267) at single dose on 09Feb2021 14:15 in left arm for COVID-19 immunisation. Medical history included severe respiratory infection from Nov2019. Patient thought she might have had COVID, but she was way early, before anyone knew it was in the country, back in Nov2019, she had a severe respiratory infection. Patient stated that her husband was a respiratory therapist, and he fortunately had enough albuterol to choke a horse with, and if it had not been for that and the nebulizer, the caller would have had to go to the hospital. Patient stated that she would wake up in the night and need three or four treatments. Patient stated that before being sick, she had horses and it would take 15-20 minutes to do her routine with the horses, but while she was sick, it took two hours. Patient stated that she would walk out and back, and it was an ordeal, she was tired and short of breath. Patient stated that the doctors called it severe respiratory inflammation, and that was in Nov and Dec2020. Patient stated that she was put on steroids at that time, and she really didn't want to go back to the doctor, so she took some of her husband's steroids, he had some dexamethasone, and she took that and started to feel better. There was no concomitant medication taken. Patient reported flu-like symptoms on 11Feb2021 after her first dose of Pfizer Covid19 vaccine. Symptoms included fever, chills, aches, pains, vomiting, abdominal pain -felt like severe case of the flu on 11Feb2021. Patient would like to know if these were normal adverse events and if they could be worse for her, because she may have had a Covid infection previously. Patient asked what was the efficacy after one dose of the Pfizer-Biontech Covid19 vaccine if she chose not to get the second dose. Patient took her first dose of the Pfizer COVID vaccine on 09Feb2021. Patient stated that two days later, she had side effects and had had them for the last 6 days. Patient stated that if someone picked it, she had it. Patient stated that she had a fever, chills and pain. Patient's fever was running at 102.5 in Feb2021, and she could get it down with paracetamol (TYLENOL) and alcohol. Patient stated that she heard somewhere that the first dose offers 85% protection against the virus, and she was wondering if that was accurate. Caller was scheduled for her next dose on 09Mar2021. Patient was still having aches and pains, and she had vomiting. Patient stated that she was still not over this part of it yet. Patient stated that her side effects started on 11Feb2021 between 4 and 5PM, so more than 48 hours later and they all of a sudden just hit her. Patient stated that the vomiting had stopped, but she did still get some abdominal pain once in a while, but the vomiting stopped about two days ago, but for a while she could not keep food down, and she was just trying to take paracetamol (TYLENOL). For events fever, chills, aches and pain, patient confirmed that these were all still ongoing, but they were getting better. Patient stated that these side effects were a little better yesterday, the caller got up and took a dexamethasone 5 mg and felt better. Patient stated that when she woke up this morning, she was feeling god awful, so she took another dexamethasone, and she was better this afternoon. Patient planned to go to an urgent care today, but she had not been to a doctor yet. Patient stated that they must not have been that serious because she did not go to a doctor, it was like a bad case of the flu, feeling like she got run over with a truck. Patient stated they were serious, but nothing life threatening, caller confirmed all side effects were medically significant. Patient stated that she read that people who had COVID, would react with more severe side effects to the vaccine than people who did not have COVID, and she was wondering if that was correct. The outcome of event vomiting was resolved in Feb2021, outcome of event abdominal pain was unknown. The outcome of rest events was resolving. The patient assessed drug result was related for all the events, Method of assessment: Global Introspection.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported ""flu-like symptoms and associated fever, chills, aches, pains, vomiting, abdominal pain "" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. More information such as complete medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/11/2021,2.0,UNK,,,Medical History/Concurrent Conditions: Respiratory infection; Suspected COVID-19,,,"['Abdominal pain', 'Body temperature', 'Chills', 'Influenza like illness', 'Pain', 'Pyrexia', 'Vomiting']",1,PFIZER\BIONTECH, 1090478,FL,70.0,F,"my blood pressure was high; Was told that I have Congestive Heart Failure , which I did not have before the Vaccines .; watering my lungs; watering my lungs; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient (not pregnant) received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration in left arm on 18Feb2021 13:00 at single dose for COVID-19 immunization. Medical history included ongoing high blood pressure, diabetes, penicillin allergy, sinus rhythm (had been in sinus rhythm for a long time), atrial fibrillation. No Covid prior vaccination. Concomitant medication included dabigatran etexilate mesilate (PRADAXA). The patient previously took first dose bnt162b2 in left arm on 29Jan2021 at the age of 70-year-old for COVID-19 immunization and after the first vaccine, patient went to the ER with shortness of breath and in A fib (atrial fibrillation). Had water in patient's lungs, stayed for 5 days. After the second vaccine in Feb2021, patient's blood pressure was high. Back to the ER, watering patient's lungs, Stayed for another 5 days. It was told that patient had Congestive Heart Failure, which patient did not have before the Vaccines. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. The patient was hospitalized for the events for 5 days. The patient underwent lab tests and procedures which included Nasal Swab: negative on 22Feb2021, blood pressure measurement: high in Feb2021, blood pressure measurement: high on unknown date. Therapeutic measures were taken as a result of events (unspecified medications). The outcome of the events was reported as recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,02/18/2021,02/01/2021,,UNK,PRADAXA,Blood pressure high,Medical History/Concurrent Conditions: Atrial fibrillation; Diabetes; Penicillin allergy; Sinus rhythm (had been in Sinus rhythm for a long time),,,"['Blood pressure measurement', 'Cardiac failure congestive', 'Disease recurrence', 'Hypertension', 'Pulmonary oedema', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1090598,FL,,M,"Covid pnuemonia; Tested positive for Covid 19; A spontaneous report was received from a Consumer concerning male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Positive for Covid-19 and Covid pneumonia. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Feb 2021, approximately 8-13 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient tested positive for Covid 19. On 16 Feb 2021 the patient experienced Covid pneumonia with seriousness criteria. Treatment included steroids and antibiotics. Laboratory details include SARS-CoV-2 test positive (Positive for covid-19) on 11-FEB-2021. On 22-feb-2021 the symptoms of covid pneumonia have resolved Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event Positive for covid-19 was unknown and the event of Covid pneumonia considered as recovered/resolved on 22-FEB-2021.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of Covid-19 and Covid pneumonia, are assessed as unlikely related. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/04/2021,02/11/2021,7.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,"['COVID-19', 'COVID-19 pneumonia', 'SARS-CoV-2 test positive']",1,MODERNA,OT 1090671,NH,54.0,F,"Within 5-10 minutes I began with a light cough. I stayed for the 10-15 minutes but didn't think it was an issue so left the store. On the ride home over the next1/2 hour the cough begain to increase in severity and frequency and then I lost my voice and was uable to speak. My husband turned around and brought me to the urgent care located near the pharmacy where I got my vaccination. They gave me an epipen and several IV drugs including a steroid, antihistamine and a few others I don't remember and transported my to hospital for observation. Within 3-4 hours my voice begain to return so I was sent home with more prescriptions. My voice is better but has not fully returned.",Not Reported,,Yes,Not Reported,,Not Reported,N,03/10/2021,03/10/2021,0.0,PHM,"Wellbutrin-300mg/day, Irbesartan-75mg/day, Claritin-10 mg/day, probiotic-1/day, CBD- 20mg/day, Eldeberry suppliment-400mg/daily, omeprazol-20 mg1/week",,"Asthma, situation, under control, no instances or medications needed for 2 years, stomach acid, managed with omeprazol once a week or two.",,"Penecillin, vicodin, adhesive, all create a rash","['Aphonia', 'Blood test', 'Cough', 'Speech disorder']",1,MODERNA,IM 1090674,OH,73.0,F,Acute ischemic lacunar stroke in left ligament resulting in mild left leg weakness,Not Reported,,Not Reported,Yes,,Yes,U,03/09/2021,03/10/2021,1.0,UNK,"amlodipine, atorvastatin, benazepril, glipizide, metoprolol tartrate, Tresiba insulin, triamterene-hydrochlorothiazide",None,"History of ischemic stroke, diabetes mellitus type 2, hypertension, dyslipidemia, GERD, lumbar spondylosis, chronic kidney disease",,"Oxycodone, CT contrast dye, diatrizoate meglumine","['Ischaemic stroke', 'Lacunar stroke', 'Magnetic resonance imaging head', 'Muscular weakness']",1,MODERNA,IM 1090733,CO,65.0,M,"The patient is a very pleasant 65 year old gentleman with a history of hypertension who presents to the hospital reporting a fever, cough, and chest pain starting two weeks ago. He states that he has had flu-like symptoms for the previous two weeks with a prominent nighttime fever and sweats. He states that he had a similar episode approximately one year ago. He reports that since Saturday he became short of breath. He states that when he goes and feeds the horses and walks back he is short of breath and needs to rest. He denies any myalgias, nausea, vomiting, diarrhea, or abdominal pain. He reports that he has chest heaviness. In the emergency department he was diagnosed with pulmonary emboli with large clot burden. He states that he has never had a blood clot. He has no family history of cancer, deep venous thrombosis, or pulmonary embolus. He denies any melena or hematochezia. He states he has not had a colonoscopy. He reports that over the past two weeks he has not been moving around much, saying that he has been largely confined to his chair due to his illness",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,03/04/2021,03/09/2021,5.0,PVT,,None,Hypertension,,NKDA,"['Chest discomfort', 'Chest pain', 'Cough', 'Dyspnoea', 'Illness', 'Influenza like illness', 'Mobility decreased', 'Night sweats', 'Pulmonary embolism', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1090742,NJ,81.0,M,"81 y.o. male with a past medical history of anemia, DVT, gout, hyperlipidemia, hypertension, presents to the ER with change in mental status. Patient was otherwise in his usually state of health. He got his 2nd COVID-19 vaccine on 3/5. His wife noticed on Sunday, he started acting strangely, more confused. He was given his remote, and forgotten how to use it. He came to the hospital; has progressively gotten weaker, unable to walk, swallow, severe dysphagia, pupil unreactive, patient staring at ceiling. CT head; normal; CXR is normal. Platelets: 91,000.",Not Reported,,Not Reported,Yes,,Not Reported,N,03/05/2021,03/07/2021,2.0,PVT,Metoprolol Levothyroxine Statin Flomax Oxybutin,None,CAD PVD Spinal stenosis DVT,,None,"['Abnormal behaviour', 'Asthenia', 'Chest X-ray normal', 'Computerised tomogram head normal', 'Confusional state', 'Dysphagia', 'Gait inability', 'Mental status changes', 'Platelet count decreased', 'Pupillary light reflex tests abnormal', 'SARS-CoV-2 test negative', 'Staring']",UNK,PFIZER\BIONTECH,IM 1090743,IN,74.0,F,"Low oxygen and tightness in chest. Had 5 days in hospital for testing and nothing showed up. Got 2 vaccination and same reaction. My brother got his first vaccination, he had identical side effect and was advised not to get second shot. All were Moderna serum. My second shot was Lot#002A21A",Not Reported,,Not Reported,Yes,5.0,Yes,U,01/27/2021,01/30/2021,3.0,OTH,"Insulin, Ezetimibe, Metoprolol, 81mg Aspirin, 10 mg Antihistamine, Losartan, Levothyroxin",None,Exercised induced asthma and diabetis,,"Penacilin. Onions, Shell fish","['Angioplasty', 'Cardiac stress test normal', 'Chest discomfort', 'Computerised tomogram normal', 'Echocardiogram normal', 'Oxygen saturation decreased', 'Ultrasound Doppler']",1,MODERNA,SYR 1090776,FL,71.0,F,"beeps, noise in her ears; muscle and joint pain; muscle and joint pain; tongue was a little numb; face lips; felt paralyzed/Felt like I couldn't move it like paralyzed a little bit; whole left side of body started going numb/Left side was numb around 7 or 8 that night/all left side was numb; pains in all of her face; pain and soreness in arm/arm was painful; tachycard, high heart rate; very tired, sleepy; very tired, sleepy; headache, heavy in her head; pain in both ears; This is a spontaneous report from a contactable consumer (patient). This 71-years-Old female patient received the first dose of (Pfizer Biontech Covid 19 Vaccine, Lot No. EN6198) intramuscularly at single dose on 23Feb2021 for COVID-19 immunisation. Relevant history and concomitant drugs were unknown. Past dug included flu vaccine in Sep2020. The patient received her first dose of Covid 19 vaccine on 23Feb2021 at 3:30 in the afternoon. She came home and felt, not bad at any time but more or less towards 6:00 or 7:00 at night she started feeling bad. Her whole left side of body started going numb around 7 or 8 that night. Her arm was painful, face lips and all left side was numb. Felt like she couldn't move it like paralyzed a little bit. Clarified as whole left side, even her leg, her feet everything on that left side. She started feeling pains in bones of head, especially her face, clarified all of her face and her left side was numb even her lips on the left side were numb. Her tongue was a little numb. She had muscle and joint pain. The pain, of course, in the arm, but that was normal. Clarified pain in the arm as the injection site. She didn't feel any swell there. She did not take medication for anything. She used a lotion. The lotion was trividol aloe vera arnica caleudula and helped to relive the pain. The arm was still a little painful but it's not bad but that feeling made her tachycard, clarified as high heart rate, feeling like boom boom boom, but she did not have any shortness of breath. The high heart rate was gone the same day. She had no fever or chills. She felt very tired and slept for about 10 hours but during the sleepy she started feeling a headache she couldn't get up because she was so tired and she felt pain in both ears. She had not been to the doctor in a while. She was still old fashioned so she carries everything in a little telephone book. While trying to read information caller states she had to change her eyes. She still felt numbness in left side of left leg but she thought it might be because she had not been exercising. When she was waking up around 9am in the morning, it was yesterday that she felt better in regards to the paralyzed feeling. When pains in her face came she felt and she thought what is this? It only lasted for a little while. It was during the night. The pain and soreness in arm at injection site is still there, she did not feel any swelling, or hot at that site. She confirmed she still felt a little tired, sleepy. It's getting better. She may feel a little heavy in her head and would like to go to sleep, but she was not sleeping. She had many things to do and knew she had to be up. The headache went away and was gone on 24Feb2021. It was persisting for a while, not too hard or heavy, but it resolved by 2 or 3 in the afternoon on the 24th. In regarding to pain in ears she mentioned she no longer had. She had beeps, noise in her ears even at the time she went to bed it was better. The outcome of events paralyzed, pain in arm, tired, sleepy, was recovering, the outcome of events tachycard, pains in all of her face, pain in both ears was resovled, the outcome of other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/23/2021,0.0,UNK,,,,,,"['Arthralgia', 'Ear pain', 'Facial pain', 'Fatigue', 'Headache', 'Heart rate', 'Heart rate increased', 'Hypoaesthesia', 'Hypoaesthesia oral', 'Lip disorder', 'Myalgia', 'Pain in extremity', 'Paralysis', 'Somnolence', 'Tinnitus']",1,PFIZER\BIONTECH,OT 1090794,CA,20.0,F,"20 yo female with recent hospitalization for myocarditis. Pt initially Dx with Covid 19 on 31 Dec 2020 and received Pfizer COVID Vaccines on 19 and 09 Feb. Pt reports on 21 Feb developing fevers of 107 and stomach upset, by 25 Feb she developed chest pain, SOB, weakness, continued fevers and diarrhea. She was seen at ER on 25 Feb where she was tachycardic, hypotensive, and hyponatremic with an elevate lactate. She was transferred to another hospital and found to have a Troponin of 0.629. she was admitted from 25 Feb to 04 March. During that time she had an ECHO with an EF of 35-45% with global hypokinesis and peak BNP of 1389. Pt is currently felling well with no chest pain or shortness of breath.",Not Reported,,Not Reported,Yes,6.0,Not Reported,U,02/09/2021,02/21/2021,12.0,MIL,"Nexplanon, Iron, Elderberry Vitamin C + Zinc, Immuneti Advance",Covid 19 infection 31 Dec 2020 (2 months prior),None,,None,"['Abdominal discomfort', 'Asthenia', 'Blood lactic acid increased', 'Brain natriuretic peptide increased', 'Chest pain', 'Diarrhoea', 'Dyspnoea', 'Echocardiogram abnormal', 'Ejection fraction decreased', 'Hyponatraemia', 'Hypotension', 'Pyrexia', 'Tachycardia', 'Troponin increased', 'Ventricular hypokinesia']",2,PFIZER\BIONTECH,IM 1090862,TN,76.0,F,"DEATH-My Mother received her second Pfizer vaccine on Thursday, February 18, 2021 and died three days later on Sunday, February 21, 2021, after being admitted to the intensive care unit at Hospital. After developing an adverse reaction that started with nausea and then got progressively worse, including vomiting blood, Mom was rushed to the emergency room where she was tested for Covid-19 due to hospital policy (neg. result) and admitted to the intensive care unit. Mother died on Sunday, February 21, 2021. NOTE: Mother was doing well with her heart and renal conditions until she received the second dose of the Pfizer Covid-19 vaccine on February 18, 2021, directly or indirectly causing her death three days later on February 21, 2021. It is unfortunate that we are all advised (sometimes ill advised), particularly those with underlying conditions, to get vaccinated without the benefits of knowing when the vaccine can cause more harm than good. For obvious reasons, the approval of covid vaccines was rushed and thus the Pfizer and Moderna Studies are not thorough and lack in data to support an all call for everyone to get vaccinated in the name of herd immunity. Without the appropriate data, My Mother is DEAD! Sadly, there are probably more unreported deaths caused by the vaccine. While you have immunity from liability, you still have a moral obligation to collect data and advise accordingly. My goal is to save lives by sharing my mother?s personal experience and death after receiving the vaccine with everyone I know through every available resource. It is unconscionable that I have to shoulder the burden of getting the facts out about your vaccine so that individuals with underlying conditions can make a proper, informed decision about getting vaccinated. Sadly, I receive over 100 questions a day via social media from individuals inquiring about whether or not they or their loved ones should opt for the vaccine. I am not a medical professional?this is your job! Until you assume responsibility, I will continue advising anyone with heart and/or renal conditions to stay away from any and all covid vaccinations. Instead of the massive all call for vaccinations, we need further information and data from additional studies that will give more insight as to when the vaccine can cause more harm than good, as in My Mother?s case.",Yes,02/21/2021,Yes,Yes,1.0,Yes,N,02/18/2021,02/19/2021,1.0,PUB,Prescription: Coumadin,,"Heart and Renal. Mother was doing well with her ""underlying conditions"" until she received the second does of the Pfizer Covid-19 vaccination on Thursday, February 18, 2021, which exacerbated her heart conditon resulting in her death three days later on Sunday, February 21, 2021.",,,"['Death', 'Haematemesis', 'Intensive care', 'Nausea', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,SYR 1090877,IL,67.0,M,"Anger, big increase in talking, aggression, sleep issues He received second vaccine dose on feb 23, symptoms were much worse after that, no more than 2 hours sleep, total personality change, wants to yell at everyone, bigger increase in talking, cannot interrupt him, cannot reason with him, thinks he no mores than doctors, starting discontinuing some of his meds. He was taken to the hospital by ambulance. He is now 68. He was diagnosed with Manic (Mania) for the first time. Has since been admitted to hospital (behavioral facility) and is not cooperating with treatment. I've been told they have never seen onset of Mania at his age, and they cannot determine a reason.",Not Reported,,Not Reported,Yes,7.0,Yes,N,02/02/2021,02/15/2021,13.0,PVT,betamethasone Dipropionate carvedilol dofetilide eliquis entresto esomeprazole magnesium glimepiride jardiance metformin rosuvastatin skyrizi torsemide trulicity,"atrial flutter, was hospitalized and was treated with dofetilide",cardiomyopathy diabetes some kidney issues due to balancing of heart disease/heart failure and diuretics psoriasis,,none,"['Aggression', 'Anger', 'Blood test normal', 'Brain scan normal', 'Electrocardiogram normal', 'Electroencephalogram', 'Impaired reasoning', 'Insomnia', 'Logorrhoea', 'Mania', 'Patient uncooperative', 'Personality change', 'Sleep disorder']",2,PFIZER\BIONTECH, 1090878,FL,56.0,M,"Received Pfizer vaccine, L arm. 1 week later, developed progressively worsening L chest abscsses, complicated bacteremia with staph aureus and requiring repeat debridements in operating room including now new abscesses that are abutting sternoclavicular joint concerning for osteomyelitis. Pt also has diabetic foot ulcer R side w/ osteomyelitis discovered after he came in for chest abscesses, cultured to have MSSA/MRSA. Chest abscesses also w/ MRSA and MSSA.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/21/2021,02/28/2021,7.0,PVT,gabapentin metformin,diabetic foot ulcer chronic,"Diabetes mellitus, hypertension, chronic low back pain",,simvastatin,"['Chest wall abscess', 'Culture wound positive', 'Debridement', 'Diabetic foot', 'Osteomyelitis', 'Staphylococcal bacteraemia', 'Staphylococcus test positive', 'Wound infection staphylococcal']",UNK,PFIZER\BIONTECH,SYR 1090898,FL,76.0,M,"I developed stomach, intestinal pain, cramps. A continuous aching with a sharp pain about every 20 - 35 minutes. Lasting 36 hours. This was in my lower abdomen below belly button on the left side. Really quiet frightening, in that this was not in any material regarding side affects. I considered the emergency room Saturday night but didn't t go. Began to subside Sunday afternoon, leaving me sore to the touch. Only a little tenderness remains in the area. I have seen no physicians. I cannot speak to any permanent damage.",Not Reported,,Not Reported,Not Reported,,Yes,Y,03/06/2021,03/06/2021,0.0,OTH,"metoprolol , simvastatin, ezetimibe, aspirin, fish oil, coq10, zinc, magnesium, probiotic,",none,"medicate for high blood pressure, and cholesterol",,sulpha drugs,"['Abdominal pain lower', 'Abdominal pain upper', 'Gastrointestinal pain', 'Tenderness']",2,PFIZER\BIONTECH, 1090905,IA,77.0,F,Fever and diarrhea since 3/4. Tested positive for COVID on 3/7 and was admitted as an inpatient.,Not Reported,,Not Reported,Yes,4.0,Not Reported,N,03/04/2021,03/04/2021,0.0,SEN,,,"Alzheimer's, Obesity",,No Known Allergies,"['COVID-19', 'Diarrhoea', 'Pyrexia', 'SARS-CoV-2 test positive']",2,PFIZER\BIONTECH,IM 1090919,IN,74.0,F,Pericarditis with large pericardial effusion with early tamponade,Not Reported,,Yes,Yes,5.0,Not Reported,N,03/02/2021,03/05/2021,3.0,PUB,"Florixitin metformin gabapentin simVaststin, zytec",None,Diabetes,,Pine needles,"['Cardiac tamponade', 'Computerised tomogram thorax', 'Echocardiogram', 'Electrocardiogram', 'Inflammatory marker test', 'Pericardial effusion', 'Pericarditis']",UNK,MODERNA, 1090954,NJ,57.0,M,"Woke up with double vision, and an unstable gate. admitted to hospital for testing.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,02/16/2021,02/17/2021,1.0,PVT,Lexipro,None,None,,None,"['Computerised tomogram', 'Diplopia', 'Echocardiogram', 'Gait disturbance', 'Magnetic resonance imaging', 'Ultrasound Doppler']",UNK,MODERNA,SYR 1090965,CO,80.0,F,"Patient is a very pleasant 80 year old female with a history of hypertension and recent pelvic fracture approximately two months ago who presented to the emergency department reporting right sided chest pain. She states that her symptoms started on Sunday. She has pain with a deep breath and also with exhaling. She reports it is a sharp pain. She states that she has had no lower extremity edema or calf pain, however, she did have a shooting pain down her right leg recently. She denies any history of personal or family history of deep venous thrombosis or pulmonary embolus. She reports that she has not had any hemoptysis. She denies feeling short of breath. She denies abdominal pain, nausea, vomiting, or diarrhea. She states that she has not had any COVID exposures or known symptoms. She has received two COVID vaccine doses. She reports that she has not been sick and denies fever, chills, or cough. In the emergency department she was diagnosed with an acute pulmonary emboli in the right main pulmonary artery with extension into the segmental pulmonary arteries. There is concern for early pulmonary infarct. This has prompted admission to the hospital.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/26/2021,03/09/2021,11.0,PVT,Acetaminophen-hydrocodone p.r.n. Cyclobenzaprine 5 mg p.r.n. Dorzolamide ophthalmic 2% t.i.d. Alendronate 70 mg every week. Ropinirole 0.25 mg b.i.d. Estradiol 0.5 mg daily. Lisinopril 20 mg daily.,Pelvic fracture 2 months prior,Hypertension. Osteoporosis.,,nkda,"['Chest pain', 'Pain', 'Pain in extremity', 'Painful respiration', 'Pulmonary embolism']",2,MODERNA,IM 1091006,IA,80.0,M,Weakness and shortness of breath,Not Reported,,Not Reported,Yes,3.0,Not Reported,U,03/06/2021,03/06/2021,0.0,PUB,,,"Coronary Artery Disease, Hypertension, Diabetes, Obesity",,No Known Allergies,"['Asthenia', 'Dyspnoea', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 1091051,NY,70.0,M,"Patient got up from chair to pick up his phone and collapsed, diaphoretic. There was no loss of consciousness. Initial BP = 80/60 and HR =84. He had no symptoms other than sweating and dizzyness. He stated he felt dizzy after the vaccine but had not eaten since the night before. He also said sometimes gets dizzy after shots. Repeat BP was 110/60 EKG by EMS demonstrated ST wave changes and patient was sent to Medical Center by EMS.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/10/2021,03/10/2021,0.0,OTH,None,None known,None,,None,"['Catheterisation cardiac normal', 'Dizziness', 'Electrocardiogram ST segment abnormal', 'Hyperhidrosis', 'Syncope']",1,JANSSEN,IM 1091063,TX,63.0,F,"Pfizer-BioNTech COVID- 19 Vaccine EUA Approximately 5 minute post vaccination, patient experienced chest pain radiating down left arm, shortness of breath, and nausea. Patient also endorses numbness to left upper arm and left lower leg. Denies any wheezing, throat swelling, facial swelling, diarrhea, urticaria. Vitals: BP 104/65, Pulse 78, SpO2. On chart review, she had similar symptoms in the past with full stroke workup that was ultimately determined to be conversion disorder. Admitted for observation to rule out ACS. EKG and serial troponin unremarkable.",Not Reported,,Not Reported,Yes,,Not Reported,,03/09/2021,03/09/2021,0.0,PVT,"Fluoxetine 20 mg daily, duloxetine 30 mg daily, (cont.) Additional information for Item 9: Prazosin 2 mg dailys, Doxepin 50 mg daily, Buspirone 15 mg Twice daily, Omeprazole 20 mg daily, Insulin detemir 40-50 units twice daily, Insulin Lis",,"COPD, Chronic Kidney Disease stage 3, Acquired hypothyroidism, Diabetes mellitus type 2, Diabetic neuropathy, (cont.) Additional information for Item 12: benign essential tremor, Conversion disorder, essential hypertension, hyperlipidemia, depression with anxiety.",,"Methocarbamol (anaphylaxis), Penicillins (anaphylaxis), con Additional information for Item 10: Bupropion (NOS), Celecoxib (rash), Codeine (hives), Mirtazepine (NOS), Morphine (rash), Nuts (hives), Simvastatin (rash), Trazadone (NOS), Sulfasalazine (rash)","['Chest pain', 'Dyspnoea', 'Electrocardiogram normal', 'Hypoaesthesia', 'Injection site hypoaesthesia', 'Nausea', 'Pain', 'Pain in extremity', 'Troponin normal']",1,PFIZER\BIONTECH,IM 1091133,IL,68.0,F,"Three days after dose 1 I experienced dizziness and violent vomiting (for 8 hours). Taken to emergency room. Admitted to hospital for hospital for 1 day. Was given anti-vomiting/dizziness drugs, CT scan, IV for dehydration, pain and anxiety medicine. Diagnosis was vertigo. Upon release from hospital, consult with internist further diagnosed condition as labarynthitis. Headache and slight dizziness continued for a couple of weeks . After second dose dizziness, light-headedness and headache are significant enough to take Tylenol regularly. These effects are still in place 12 days after 2nd dose. Will see internist if symptoms continue after 2 weeks.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/01/2021,02/04/2021,3.0,SCH,"Centrum Silver , Singular, Vitamin D, Fish oil, biotin, calcium citrate, omepresale","mild herniated disk 3 weeks prior to vaccine dose 1, was prescribed a 5 day steroid for inflammation","gastric reflux, herniated disks",,allergy to dust mites,"['Anxiety', 'Cardiac monitoring', 'Chest pain', 'Computerised tomogram', 'Dehydration', 'Dizziness', 'Headache', 'Labyrinthitis', 'Pain', 'Vertigo', 'Vomiting']",2,PFIZER\BIONTECH,IM 1091138,NH,83.0,M,pt returned to his skilled nursing facility after his 2nd covid vaccine and at approx 10:45 pm he was in cardiac arrest. CPR was started and transported to Hospital. Pt was pronounced dead at 1:06 am on 3/11/21,Yes,03/11/2021,Not Reported,Not Reported,,Not Reported,N,03/10/2021,03/10/2021,0.0,PVT,ALBUTEROL 90MCG (CFC-F) 200D ORAL INHL INHALE 2 PUFFS BY MOUTH EVERY 4 HOURS AS NEEDED VALSARTAN ***ARB-2ND LINE*** TAB 320MG TAKE ONE TABLET BY MOUTH EVERY DAY ATORVASTATIN***LIPID-1ST LINE,"Pt was just hospitalized for the following issues: NSTEMI, LE ischemia. acute diastolic HF, bilat iliac stents.",NSTEMI GERD HTN laryngeal cancer COPD,,BUDESONIDE/FORMOTEROL OLODATEROL/TIOTROPIUM,"['Cardiac arrest', 'Death', 'Resuscitation']",2,MODERNA,IM 1091158,MN,95.0,F,patient passed away with in 60 days of receiving the COVID vaccine series,Yes,03/06/2021,Not Reported,Not Reported,,Not Reported,,02/23/2021,03/06/2021,11.0,SEN,,,,,,['Death'],UNK,MODERNA, 1091164,NE,73.0,F,"patient experienced tightness in chest and difficulty breathing, requested staff call 911 for squad. Did not want to have personal EPI pen administered. EMS arrived 10 minutes after onset and was taken to ER. Rec'd call from pt. at vaccine site on 3/11/21 (day after vaccine administration) stating she was given EPI 3x in ambulance and transferred to ICU.",Not Reported,,Not Reported,Yes,,Not Reported,N,03/10/2021,03/10/2021,0.0,OTH,"multiple supplements tramadol, gabapentin, pantoprazole, amour, xyzal, singulair, metformin, bydureon, basaglar, fiasp, rosuvastatin, fenofibrate, aspirin, carvedilol, jardiance, xopenex, symbicort","fibromyalgia, back surgery","HBP, High cholesterol, diabetes, asthma, fibromyalgia, anxiety",,"flu shots, levoquin, doxy, actonel, fosomax, biaxin, sulfa, clindamycin, plavix","['Chest discomfort', 'Dyspnoea', 'Intensive care']",1,PFIZER\BIONTECH,IM 1091169,TX,67.0,F,ACUTE STEMI HEART ATTACK - VENTRICULAR FIBRILLATION - 99.9% BLOOD CLOT IN RIGHT CORONARY ARTERY,Not Reported,,Yes,Yes,3.0,Not Reported,U,02/08/2021,02/18/2021,10.0,OTH,Losarton. 25 mg. 1/day simvastatin. 20 mg. 1/day oxybutynin. 10 mg. 1/day,none,osteoarthritis feet/ankles/hands incontinence,,none,"['Acute myocardial infarction', 'Arteriogram', 'Blood test', 'Coronary artery thrombosis', 'Electrocardiogram', 'Myocardial infarction', 'Ventricular fibrillation']",2,MODERNA,SYR 1091239,,80.0,F,"severe thrombocytopenia, mucosa bleeding causing hemoptysis, cutaneous ecchymosis treated with IVIg, pulse steroids, and platelet transfusion.",Not Reported,,Not Reported,Yes,2.0,Not Reported,,02/06/2021,02/16/2021,10.0,UNK,,,,,,"['Ecchymosis', 'Haemoptysis', 'Immunoglobulin therapy', 'Mucosal haemorrhage', 'Platelet transfusion', 'Thrombocytopenia']",2,PFIZER\BIONTECH,IM 1091248,MD,63.0,M,"Started with nose bleeds on Sunday, January 17, 2021 in the evening around 6:00pm. Awoke Monday morning January 18, 2021 noticed small black spots on my face and inside my mouth and on my tongue. I was also experiencing shortness of breath. I was transported to the hospital via ambulance. I was admitted to the hospital received four (4) blood transfusions. Slowly my platelet count began to rise. I was discharge from the hospital on January 24, 2021. Currently being monitored/treated by my Hematologist.",Not Reported,,Yes,Yes,7.0,Not Reported,U,01/07/2021,01/17/2021,10.0,OTH,Metformin 750mg twice daily Lisinopril 20mg once daily Rosuvastatin 10mg once daily Centrum Silver Multivitamin one daily,none,Diabetes High Blood Pressure High Cholesterol Neck and Back Pain Arthritis left knee,,Penicillin Sulfa Drugs,"['Blood test', 'Dyspnoea', 'Epistaxis', 'Laboratory test abnormal', 'Mouth haemorrhage', 'Petechiae', 'Platelet count decreased', 'Transfusion', 'X-ray']",1,MODERNA,SYR 1091264,CT,33.0,F,"Patient is 4 mos postpartum and is breast feeding Became lightheaded, dizziness and reported visual changes, Supine blood pressure 77/52 HR 100 / min Administered juice . After 5 min supine BP rose to 96/67 Patient continued to feel dizzy and EMS called Extremities were cool to touch Standing BP 60/42 following arrival of EMS (Patient felt weak and unable to stand Placed on stretcher and transported to Hospital Chest clear Airway Clear No wheezing .",Not Reported,,Yes,Not Reported,,Not Reported,U,03/11/2021,03/11/2021,0.0,PUB,None,None,History of vaso-vagal episodes,,Penicillin,"['Asthenia', 'Dizziness', 'Dysstasia', 'Peripheral coldness', 'Visual impairment']",1,MODERNA,IM 1091267,CT,87.0,M,"In one week fell and was in Icu. now in rehabilitation. can't walk. very weak, even voice sounded different. All test were negative. Don't really know what happened.",Not Reported,,Not Reported,Yes,3.0,Yes,N,02/26/2021,03/05/2021,7.0,PUB,finasteride low dose aspirin,none,prostate inlarged,,NKA,"['Asthenia', 'Blood test normal', 'Computerised tomogram normal', 'Dysphonia', 'Fall', 'Gait disturbance', 'Intensive care', 'Magnetic resonance imaging normal', 'Urine analysis normal']",2,MODERNA,UN 1091269,MI,83.0,M,A home dialysis patient who received his first COVID-19 (Moderna) vaccine on 2/4/2021. He was screened prior to admission into the clinic and reported no signs of symptom of COVID-19. This patient was diagnosed with COVID-19 on 2/12/2021 and hospitalized on 2/16/2021 with COVID pneumonia. The patient's spouse and son (who lives with them) also tested positive for COVID-19. This patient developed COVID-19 complications while inpatient including stroke and mechanical ventilation was required. The patient was made a DNR by family and removed from mechanical ventilation and expired on 2/26/2021.,Yes,02/26/2021,Not Reported,Yes,10.0,Not Reported,N,02/04/2021,02/12/2021,8.0,OTH,"Aranesp, Amlodipine, Aspirin, Eliquis, Furosemide, Nephrocaps, Tamsulosin, Vitamin D, Renvela, Senna, Tessalon Perles",,"ESRD, Meniere's Disease, Atrial Fibrillation, Coronary Artery Disease, Hypertension, Renal Osteodystrpphy Secondary Hyperparthyrodism, Anemia, BPH",,"Sulfa, Vancomycin","['COVID-19', 'COVID-19 pneumonia', 'Cerebrovascular accident', 'Death', 'Mechanical ventilation']",1,MODERNA,IM 1091292,MN,81.0,M,"went to the hospital for 5 days and had 5 infusions, one each day. He was diagnosed with Guillain Barre Syndrome. currently in rehab going on 3 weeks now.",Not Reported,,Not Reported,Yes,5.0,Yes,,02/13/2021,02/22/2021,9.0,OTH,Eliquis amiodarone b-12 baby aspirin Flonase loratadine mexiletine Montelukast metoprolol omeprazole Crestor Vyndamax,No,Heart issues,,Sulfa Drugs,['Guillain-Barre syndrome'],1,MODERNA,SYR 1091327,FL,63.0,F,Death,Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/02/2021,03/02/2021,0.0,PVT,Not sure,Not sure,Not sure,,Not sure,['Death'],UNK,MODERNA, 1091336,TX,37.0,F,Severe pain on right side of stomach. It was determined that I had a kidney stone (2/23/21) I was hospitalized for the stone on 2/25/21 due to kidney stone. . I'm otherwise a health individual with no prior issues with kidney stones. Ureteroscopy (2/26/21).,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/15/2021,02/23/2021,8.0,PHM,none,Urinary Tract infection about a mouth prior to vaccine.,none,,none,"['Abdominal pain upper', 'Computerised tomogram', 'Nephrolithiasis', 'Ultrasound abdomen', 'Ultrasound scan vagina', 'Ureteroscopy']",1,MODERNA,SYR 1091337,MI,77.0,F,This is a hospice patient. She died on 2/13/2021 from her underlying medical conditions. I just received notification of the death 3/11/2021 and am reporting this immediately.,Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/13/2021,10.0,PVT,"atenolol, azelastine, cannabidiol, nexium, haloperidol, hydralazine, norco, hyoscyamine, xopenex HFA, lorazepam, mirtazapine, morphine oral solution, multivitamin, nifedipine, oxygen, senna, tumeric, umeclidinium-vilanterol, magic mouthwash","COPD, diastolic heart failture, mesenteric ischemia, stage III chronic kidney disease, osteoporosis, coronary artery disease with angina",,,"cephalexin - hives yerba mate - hives, itching boniva - hip pain",['Death'],1,MODERNA,SYR 1091340,GA,74.0,F,"Chills, high fever, nausea, uncontrollable shaking, extreme weak, extreme fatigue, terrible headache, body aches, injection site sore and swollen,",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,03/09/2021,03/09/2021,0.0,PVT,"hydrocodone, amlodipine, atenolol, singular, flonase spray",CLL - non symptomatic,"chronic pain: neck, back, shoulders","Shingrex after second dose nausea, fatigue, swollen at injection site",,"['Asthenia', 'Chills', 'Fatigue', 'Headache', 'Injection site pain', 'Injection site swelling', 'Nausea', 'Pain', 'Pyrexia', 'Tremor']",2,MODERNA,IM 1091341,GA,80.0,M,"couldn't stand, right arm weak, couldn't stand on left leg,",Not Reported,,Not Reported,Yes,,Not Reported,N,03/08/2021,03/10/2021,2.0,UNK,,,,,,"['Dysstasia', 'Muscular weakness', 'Neurological examination']",2,PFIZER\BIONTECH,IM 1091356,WY,75.0,M,Pt started to have epigastric pain three days after 1st and second doses of Moderna CV 19 vaccine.,Not Reported,,Not Reported,Yes,2.0,Not Reported,U,01/26/2021,01/29/2021,3.0,PUB,Insulin BP Med Lovenox Chemo,Cancer of pancreas,Ca pancreas X 1 year Tumors in lung IDDM,,KNA,['Abdominal pain upper'],1,MODERNA,IM 1091357,TX,72.0,M,Patient died suddenly and unexpectedly on 2/21/2021 one week after receiving first vaccine on 2/20/2021.,Yes,02/27/2021,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/27/2021,7.0,OTH,,"Heart disease- pacemaker, cancer of prostate, arthritis , peripheral vascular disease,",See above.... I am his wife and I want to report to you that he died on 2/27/21 very suddenly and unexpectedly.,,NKA,['Sudden death'],UNK,PFIZER\BIONTECH, 1091388,NE,73.0,F,throat swelling concern for anaphylaxis,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/10/2021,03/10/2021,0.0,OTH,"aspirin, carvedilol. pepcid, loratadine, monetelukast, crestor, gabapentin, tramadol, aspart, armour thyroid",None,"type II diabetes, asthma, hypothyroidism, hypertension",,"sulfa drugs, doxycycline, clindamycin, dicloxacillin, plavix, fosfamax, levaquin",['Pharyngeal swelling'],1,PFIZER\BIONTECH,IM 1091423,NJ,61.0,M,"Pain in ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection; Sugar was very high; Blood pressure was very high; Face look flushed; A spontaneous report was received from a consumer concerning a 61-years-old male patient who experienced pain in ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection (cellulitis), sugar was very high (blood glucose increased), blood pressure was very high (blood pressure increased), and face looked flushed (flushing). The patient's medical history included diabetes mellitus, heart disease (unspecified), kidney failure, and chronic obstructive pulmonary disease (COPD). Products known to have been used by the patient, within two weeks prior to the event, included insulin and oral medications for diabetes (unspecified), rosuvastatin calcium, acetylsalicylic acid, umeclidinium bromide and vilanterol trifenatate, diuretics unspecified (water pills), omeprazole magnesium, and cortisone. On 15 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 038K20A) intramuscularly for prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient got cortisone injection. On 18 Feb 2021, the patient experienced high sugar level, high blood pressure and face looked flushed. On 20 Feb 2021, the patient started having pain in the ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection. Treatment for the events included Keflex. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events of pain in ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection, sugar was very high, blood pressure was very high, and face looked flushed, was considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/15/2021,02/18/2021,3.0,UNK,INSULIN; CRESTOR; BABY ASPIRIN; ANORO; PRILOSEC [OMEPRAZOLE MAGNESIUM]; CORTISONE,"COPD; Diabetes mellitus; Heart disease, unspecified; Kidney failure",,,,"['Blood glucose increased', 'Blood pressure increased', 'Cellulitis', 'Flushing']",1,MODERNA,OT 1091424,NC,48.0,F,"anaphylactic shock; BP 209/109 within 15 minutes of the shot/elevated BP; major headache; This is a spontaneous report from a contactable other HCP. This other HCP reported for herself that a 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) at the age of 48-years, via an unspecified route of administration in left arm on 28Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included nerve damage; multiple surgeries from a wreck. Patient was not pregnant, was not pregnant at time of vaccination, there was no other vaccine in four weeks. No COVID-19 prior vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA); loratadine (CLARITIN); colecalciferol (VITAMIN D); ascorbic acid (VITAMIN C); probiotics nos. The patient previously took rofecoxib (VIOXX), miconazole nitrate (MONISTAT), gabapentin, flu shot, all experienced allergies. At 10:45 AM on 28Jan2021, the patient experienced shortness of breath (SOB), BP 209/109 within 15 minutes of the shot, clammy, major headache. Received diphenhydramine hydrochloride (BENADRYL) on site and transferred by ambulance to hospital where she received Epishot, dexamethasone and ketorolac tromethamine (TORADOL). Diagnosed with anaphylactic shock. Went home with elevated BP and major headache. Daughter called an ambulance that night because the headaches were so bad. Ambulance driver stated they couldn't do anything for patient at the hospital unless she exhibited stroke like symptoms. BP stayed elevated for 2 days and headaches continued. Started to feel better 5 days later. Followed up with her PCP and patient was put on steroids for 5 days to taper down. The adverse events resulted in doctor or other HCP office/clinic visit, emergency room/department or urgent care. Patient received BENADRYL, epinephrine, dexamethasone, TORADOL as treatment for AEs. Lab data included: patient was tested negative for COVID-19 virus test (nasal swab) on 23Feb2021. Outcome of the events was recovered in Feb2021.; Sender's Comments: Based on the close temporal relationship, the association between the events anaphylactic shock, BP increased and headache with BNT162b2 use can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Yes,Yes,,Not Reported,Y,01/28/2021,01/28/2021,0.0,UNK,CYMBALTA; CLARITIN [LORATADINE]; VITAMIN D [COLECALCIFEROL]; VITAMIN C [ASCORBIC ACID]; probiotic NOS,,Medical History/Concurrent Conditions: Nerve damage; Surgery (multiple surgeries from a wreck.),,,"['Anaphylactic shock', 'Blood pressure increased', 'Blood pressure measurement', 'Headache', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1091425,LA,85.0,F,"arm swelling; had syncopal episodes; nausea; hematoma; hot flashes; palpitations; dry heaving; This is a spontaneous report from a contactable other hcp. An 85-year-old female patient receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), at same age, intramuscular in right arm on 23Feb2021 10:45 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) on 27Jan2021 03:15 AM, intramuscular in right arm for covid-19 immunisation. The patient was arrived at emergency room complains of arm swelling at 6pm 23Feb2021, and had syncopal episodes, nausea. lt 'upper ext hematoma', hot flashes, palpitations, and dry heaving, all on 6pm 23Feb2021. Emergency room visit for all events. The patient underwent lab tests and procedures which included post covid-19 rapid screening: negative on 24Feb2021. Patient is not pregnant. Facility type vaccine was Hospital. It is unknown if other vaccine in four weeks or other medications in two weeks. The medication for symptoms was received for all events. The patient was admission to hospital. No COVID prior vaccination. The outcomes of events were unknown.; Sender's Comments: The causal association of the reported events and suspected drug BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINEc cannot be excluded based on temporal relation of drug administration and presentation of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate",Not Reported,,Not Reported,Yes,,Not Reported,U,02/23/2021,02/23/2021,0.0,PVT,,,,,,"['Haematoma', 'Hot flush', 'Nausea', 'Palpitations', 'Peripheral swelling', 'Retching', 'SARS-CoV-2 test', 'Syncope']",2,PFIZER\BIONTECH,OT 1091426,CA,57.0,F,"brain fog; sleepy; basophils are a little elevated; orthostatic hypotension; dizziness; weakness; extreme burning in her lower extremities and hands; nerve pain 9 out of 10; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ON5318), via an unspecified route of administration in the left arm on 08Feb2021 at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient has been having a lot of side effects. The patient experienced common weakness on 09Feb2021 which was expected, extreme burning in her lower extremities and hands but it was worse in her lower extremities which occurred 4-7 days after vaccination in Feb2021, orthostatic hypotension and dizziness on 12Feb2021, nerve pain 9 out of 10 in Feb2021 which has subsided as of 20Feb2021 or 21Feb2021, super weak, brain fog and sleepy on unknown date. As of 24Feb2021, patient still had orthostatic hypotension and weakness. Stated they have done a CBC on her and everything looks good, her basophils are a little elevated but it is nothing serious. The patient is concerned about the second dose, does not think patient is going to get it. Outcome of events weakness, orthostatic hypotension and dizziness was not recovered, events extreme burning in her lower extremities and hands and nerve pain 9 out of 10 was recovered in Feb2021. Outcome of other events was unknown.; Sender's Comments: The causal association between the reported event nerve pain which was 9 out of 10 according to the patient and the BNT162B2 COVID-19 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Asthenia', 'Basophil count', 'Basophil count increased', 'Burning sensation', 'Dizziness', 'Feeling abnormal', 'Full blood count', 'Neuralgia', 'Orthostatic hypotension', 'Pain assessment', 'Somnolence']",1,PFIZER\BIONTECH, 1091427,NJ,,F,"felt like she was having a ""heart attack""; extremely nauseous and dizzy; extremely nauseous and dizzy; reported stiffness in both legs and could not walk; reported stiffness in both legs and could not walk; This is a spontaneous report from a contactable pharmacist. An elderly (65+ Years) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 23Feb2021 at SINGLE DOSE for covid-19 immunisation. The patient was not Pregnant at Time of Vaccination. Facility type vaccine was Public Health Clinic/Administration facility. The patient medical history and the concomitant medications were not reported. The patient previously received first dose of bnt162b2 intramuscular on unknown date at SINGLE DOSE for covid-19 immunisation. After 2nd dose on 23Feb2021, the patient felt extremely nauseous and dizzy, felt like she was having a ""heart attack"" though no reported difficulty breathing or anaphylaxis. The patient also reported stiffness in both legs and could not walk and do could not reach phone to call anyone. No treatment received. The outcome was unknown. No covid prior vaccination. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal relationship, the causal association between BNT162B2 and the reported ""felt like having a heart attack"" cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,02/23/2021,0.0,PUB,,,,,,"['Dizziness', 'Gait disturbance', 'Musculoskeletal stiffness', 'Myocardial infarction', 'Nausea']",2,PFIZER\BIONTECH,OT 1091439,SC,78.0,F,"fell/passed out (unknown) at home, taken by ambulance to local hospital, small bleed noted on CT scan, transferred to tertiary care center, f/u scan after 6 hours unchanged. Sent home. next morning unresponsive, transported back to tertiary care center. required ventilation en route.. massive cerebral hemorrhage noted on CT scan in different area. due to advanced dementia and unresponsiveness life support removed around 9pm that night. passed away at 9am on 3/1.",Yes,03/01/2021,Not Reported,Yes,3.0,Not Reported,N,02/25/2021,02/26/2021,1.0,PHM,none,none,"dementia, type 2 diabetes diet controlled, hypothyroidism",,none,"['Cerebral haemorrhage', 'Computerised tomogram abnormal', 'Death', 'Dementia', 'Fall', 'Haemorrhage', 'Loss of consciousness', 'Mechanical ventilation', 'Unresponsive to stimuli']",2,MODERNA,SYR 1091446,CO,74.0,F,"74 y.o. female with a history of hypertension and hyperlipidemia who was admitted to this hospital on February 25, 2020 4 hours after the development of left-sided weakness. She was found to have an acute ischemic stroke. She has had slow progression with therapy but is now able to ambulate with a walker. She is in need of further rehab, hence the transition to swing bed. She denies any new complaints today, including headache, chest pain, shortness of breath, palpitations or feelings of tachyarrhythmias. The sensory deficits on the left side have improved in particular in her left upper extremity. She is noting some improvement as well and strength. No new focal neurological deficits",Not Reported,,Not Reported,Yes,12.0,Yes,,02/22/2021,02/24/2021,2.0,PVT,,,,,,"['Hemiparesis', 'Ischaemic stroke', 'Sensory loss', 'Walking aid user']",2,PFIZER\BIONTECH,IM 1091448,WI,69.0,F,"patient started feeling adverse effects on 3/7/2021, day after vaccination. She reports being nauseous, appetite loss, fatigue, no fever and having diarrhea. She had the corona virus 19 in November and was hospitalized. We recommended to take loperamide for the diarrhea or Pepto-bismol and emetrol or nauzene for nausea. She wanted to go to urgent care which we said is a good idea.",Not Reported,,Not Reported,Yes,8.0,Not Reported,N,03/06/2021,03/07/2021,1.0,PHM,patient did not disclose,patient was hospitalized for covid19 in november,did not disclose,,patient did not disclose,"['Decreased appetite', 'Diarrhoea', 'Fatigue', 'Nausea']",1,MODERNA,IM 1091497,CO,64.0,F,"64 y.o. female who is consulted for possible stroke. Patient reports that she awoke this morning (3/10/2021) at about 4:30 PM with severe spinning dizziness. She reports associated nausea, diaphoresis, blurred vision and bilateral hand numbness and tingling. She denies speech or language problems or weakness. She reports she got a COVID vaccine (Johnson & Johnson) Sunday 93/7/2021) and felt a little ""woozy"" Monday (3/8/2021).",Not Reported,,Not Reported,Yes,2.0,Not Reported,,03/07/2021,03/10/2021,3.0,PVT,,,,,,"['Dizziness', 'Hyperhidrosis', 'Hypoaesthesia', 'Nausea', 'Paraesthesia', 'Vision blurred']",1,JANSSEN,IM 1091510,VA,50.0,F,"Immediately after getting the shot I felt nauseous and went to report my symptoms to Dr and other, when I began to vomit in my mouth I ran to the bathroom where I vomited a lot in my throat and my throat began to tighten and lost consciousness and i was given the shot of Benadryl and Dr in medical were taking my vitals and O continue to have difficulty breathing Dr administered the EPIpen in my left leg I began to violently have convulsions until ems workers arrived. I have fatigue, left side weakness, headaches, brain fog, unable to remember stuff, erratic heart rates blurred vision and shortness of breath.",Not Reported,,Yes,Not Reported,,Yes,N,02/08/2021,02/08/2021,0.0,WRK,,Diabetes and High Cholesterol,Diabetes and High Cholesterol,,Sulfa,"['Amnesia', 'Dyspnoea', 'Fatigue', 'Feeling abnormal', 'Headache', 'Heart rate irregular', 'Hemiparesis', 'Immediate post-injection reaction', 'Loss of consciousness', 'Nausea', 'Seizure', 'Throat tightness', 'Vision blurred', 'Vomiting']",2,MODERNA,IM 1091523,CA,61.0,F,Pancreatitis. hospitalized They removed my gallbladder on 3/3/21,Not Reported,,Yes,Yes,4.0,Not Reported,U,02/26/2021,,,PHM,"Jardiance, metformin,bystolic,synthroid, vit D, C. Relief factor, folic acid, praluent","Diabetes , HBP","Diabetes , spinal stenosis, hypothyroid",,"Codeine, avelox","['Cholecystectomy', 'Lipase increased', 'Pancreatitis']",1,MODERNA,SYR 1091538,WI,94.0,M,"According to his daughter, patient did not appear to have any ill effects from his second COVID-19 vaccine on 03/09/2021. However, on 03/11/2021, he suffered what is suspected to be a fatal arrhythmia/myocardial infarction. It is unknown if there is any correlation to the vaccine.",Yes,03/11/2021,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/11/2021,2.0,PVT,"Clopidogrel, Novolog, Lantus, Isosorbide, Losartan-HCTZ, Atorvastatin, Omeprazole, Furosemide",,"Diabetes, hypertension, high cholesterol, gastroesophageal reflux disease",,,"['Arrhythmia', 'Death', 'Myocardial infarction']",2,MODERNA,UN 1091544,WA,92.0,M,"On the morning of 2/22/21 Patient was found by care staff to have signs of stroke as evidence by left sided facial drooping. EMS were called and he was taken to a local hospital where he was admitted. He then was discharge to a skilled nursing facility for rehabilitation. He is still there as of today, 3/11/2021.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/17/2021,02/22/2021,5.0,SEN,"Acetaminophen, amlodipine, aspirin, carvedilol, digoxin, decussate, ferrous, fluoxetine, furosemide, lisinopril, megestrol, memantine, omeprazole, potassium chloride, quetiapine, spironolactone, tamsulosin",,"Cardiomyopathy, hypertension, dementia, depression, congestive heart failure, GERD, arthritis, BPH",,NKDA,"['Cerebrovascular accident', 'Facial paralysis']",2,MODERNA,IM 1091560,FL,82.0,M,"On January 26, patient lost his balance and fell, no injury. On January 28, patient, fell, no injury. In both cases falls were observed and were not to the head. On January 29 patient could not maintain his balance. Taken to hospital. MRI revealed large subdural hematoma. Craniotomy on January 30, by Dr. Approximately 10 days later, Hbg, was down to 7, unexplained internal bleeding.",Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,01/26/2021,4.0,SEN,"sertraline 100 mg, rousuvestatin 20 mg, trazedone, aspirin 81 mg, vitamin D3, Fiber Gummies, Melatonin 2.5, Big Red 500 mg,",None.,"Dementia, stents, high cholesterol treated, mild hearing loss.",,none,"['Balance disorder', 'Blood test', 'Craniotomy', 'Fall', 'Haemoglobin decreased', 'Internal haemorrhage', 'Magnetic resonance imaging abnormal', 'Subdural haematoma']",UNK,MODERNA, 1091588,NV,80.0,F,Developed diplopia 3 hours post vaccine,Not Reported,,Not Reported,Yes,1.0,Yes,N,01/18/2021,01/18/2021,0.0,PVT,"ZOLPIDEM (AMBIEN) 5 MG TABLET 5 MILLIGRAM ORAL AT BEDTIME AS NEEDED Venlafaxine HCl (EFFEXOR) 37.5 MG TAB 37.5 MILLIGRAM ORAL D CHOLECALCIFEROL (VITAMIN D3) (Vitamin D3) 2,000 UNIT TABLET DAILY",None,"Diverticulitis, Polymalgia rhematica, Cutaneous B-cell lymphoma",,"rituximab (From RITUXAN) (Severe, RASH ITCHING ) erythromycin base (Severe, DIARRHEA) hydromorphone HCl (From DILAUDID) (Severe, VOMIT ) meperidine HCl (From DEMEROL) (Severe, VOMIT )","['Activated partial thromboplastin time', 'Activated partial thromboplastin time shortened', 'Alanine aminotransferase normal', 'Aspartate aminotransferase decreased', 'Aspartate aminotransferase normal', 'Blood chloride increased', 'Blood cholesterol increased', 'Blood creatinine normal', 'Blood glucose normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood triglycerides normal', 'Blood urea increased', 'Blood urea normal', 'Chest X-ray abnormal', 'Computerised tomogram head normal', 'Diplopia', 'Glycosylated haemoglobin normal', 'Haematocrit decreased', 'Haemoglobin decreased', 'High density lipoprotein increased', 'International normalised ratio normal', 'Low density lipoprotein normal', 'Magnetic resonance imaging head abnormal', 'Neutrophil percentage', 'Platelet count normal', 'Prothrombin level normal', 'Prothrombin time prolonged', 'Scan with contrast', 'Ultrasound Doppler', 'Walking aid user', 'White blood cell count normal', 'White matter lesion']",1,MODERNA,IM 1091590,,18.0,F,"18 year old female came to hospital for chest tightness, choking sensation in the throat as well as skin rash after receiving COVID-19 vaccine. Initially patient presented to emergency room but subsequently discharged on steroid and Benadryl. Patient had continued episode of choking as well as chest tightness and skin rash for that patient came back to emergency room. Patient had received total 5 doses of epi pen because of that. Patient was admitted to medical floor initially. Patient was given steroid, Benadryl and famotidine. Patient had 2 episodes on medical floor where she started feeling choking and chest tightness. Patient remained stable hemodynamically except for tachycardia. Patient was transferred to intensive care unit for close monitoring. D-dimer was negative, urine tox screen was negative, COVID-19 PCR was negative, EKG showed sinus tachycardia. CT scan of neck was negative. We had discussed that patient has remained stable hemodynamically in the intensive care unit and discharge planning was discussed and patient was getting ready to be discharged when she had another episode where after drinking soda patient started having that choking sensation, patient remained stable hemodynamically during this episode as well. Her symptoms had improved. She looked visibly anxious. Patient was monitored in the ICU for few more hours and patient remained stable. I checked back on her and she was able to eat her lunch. She probably had a allergic reaction to more than a vaccine but subsequent episodes are thought to be secondary to anxiety attack given situation.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,03/09/2021,03/09/2021,0.0,PVT,Oral Contraceptive,None,None,,None,"['Anxiety', 'Chest discomfort', 'Choking sensation', 'Computerised tomogram neck', 'Drug screen negative', 'Electrocardiogram abnormal', 'Fibrin D dimer normal', 'Hypersensitivity', 'Intensive care', 'Rash', 'SARS-CoV-2 test negative', 'Sinus tachycardia', 'Tachycardia']",1,MODERNA,IM 1091627,CA,72.0,F,"Left ear hurt 11 pm 1-25-21; Violent pain/claws ripping flesh off half of face/head 2 am 1/26/21; non-amblitory, could not support weight, major balance issues. Televisit 1/26/21=earache. Blacked out cold 5 min, non responsice 30 min 2 am 1/26/21; woke with Bell's Palsey; Ddumb televisit 1/28/21=BP. Urgent Care visit-EKG (normal), bloodwork, urine lab work. 2/1/21 Saw NEURO = MRI brain w/contrast to rule out cancer (2/4/21; Two weeks of solid hallucinations 24/7. Horrendous balance issues-almost non-amblitory from onset 1/26/21 to present. Lost 9 pounds in 2 weeks.(I was 104 now 95 pounds). I was walking 5 mi a day, walked 1/24/21, healthy. Devastating pain to left side of head/face, esp ear. PAIN",Not Reported,,Yes,Not Reported,,Yes,,01/25/2021,01/26/2021,1.0,SCH,,none,,,,"['Balance disorder', ""Bell's palsy"", 'Blood test', 'Ear pain', 'Electrocardiogram', 'Electrocardiogram normal', 'Facial pain', 'Hallucination', 'Headache', 'Loss of consciousness', 'Magnetic resonance imaging head', 'Scan with contrast', 'Unresponsive to stimuli', 'Urine analysis', 'Weight bearing difficulty', 'Weight decreased']",1,PFIZER\BIONTECH,IM 1091671,TX,,M,"COVID-19; A spontaneous report was received form a physician concerning a male patient who received Modern's COVID-19 Vaccine and who developed Covid-19. The patient's medical history was not provided nor was concomitant product us. Patient was reportedly recovering from Covid-19. Prior to the onset of events, (date not provided) the patient received the first of two planned doses of mRNA-1273 (Batch number unknown) intramuscularly for prophylaxis of Covid-19 infection. The patient was diagnosed with Covid-19 after receiving the first dose of mRNA-1273 on an unknown date. The patient was hospitalized (admission date not provided). Treatment for the illness included mechanical ventilation. No other treatment information nor relevant laboratory/diagnostic tests were provided. Planned discharge date from the hospital was reported as 27-Feb-2021. The reporting physician asked whether the patient could have the second dose of vaccine which was due on 27-Feb-2021. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, Covid-19, was considered recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,N,,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: COVID-19 (Patient was in the hospital recovering from Covid-19 on date of report 26-Feb-2021 to be discharged on 27-Feb-2021. Onset date of illness was not provided.),,,['COVID-19'],1,MODERNA,OT 1091672,WV,,F,"Bleeds under her skin from knees to ankles; Left ankle is swollen; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bleeds under her skin from knees to ankles, left ankle is swollen. The patient's medical history, as provided by the reporter, included, 21 years ago the patient had a virus that attacked her spleen, she does not have her spleen. She stated that two weeks before the Moderna shot she got two hips injections. Additional suspected medications included: on 29-Jan-021, two knee injections. On 26-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection. On 13-Feb -021, the patient experienced bleeds under her skin in both legs from knees to ankles, her left ankle was swollen. She stated that the bleed spots started like little dots. She would get blood work done. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, bleeds under her skin from knees to ankles, left ankle is swollen was unknown.; Reporter's Comments: This patients petechial rash is likely due to the knee injections and unlikely to be due to Moderna Covid 19 vaccine. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/26/2021,02/13/2021,18.0,UNK,,,"Medical History/Concurrent Conditions: Splenectomy; Viral infection NOS (21 years ago, the patient had a virus that attacked spleen)",,,"['Joint swelling', 'Petechiae']",1,MODERNA,OT 1091673,TX,51.0,M,"angioedema; swollen glands below the jaw; dry mouth; canker sores; thrush; a metal taste in his mouth; swelling of lips, tongue and gums; Rash; A spontaneous report was received from a consumer concerning a 51-year-old, male patient, who received Moderna's COVID-19 vaccine and experienced angioedema, swollen glands below jaw, dry mouth, canker sores, thrush, metal taste in mouth, swelling of lips, tongue and gums. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. 0n 06 Jan 2021, prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection. The patient developed symptoms after the first dose like dry mouth, canker sores, swollen glands below the jaw, swollen tongue, thrush, a metal taste in his mouth, and swollen lips. On 05 Feb 2021, the patient received the second dose of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection. Nothing new happened after the second dose. On 29 Feb 2021 (the date will be confirmed) he went to ER received steroids, Benadryl and Pepcid. They treated him for angioedema. Most of the symptoms went away except for the swelling of the gums, rash and metallic taste. The outcome of the events, angioedema, swollen glands below jaw, swollen tongue and lip, dry mouth, canker sores, thrush, swelling of lips, tongue and were resolved. The outcome of the events metal taste in mouth, gums and rash were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/06/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Angioedema', 'Aphthous ulcer', 'Dry mouth', 'Dysgeusia', 'Lymphadenopathy', 'Oedema mouth', 'Oral candidiasis', 'Rash']",1,MODERNA, 1091674,CO,,F,"She states it felt like she may faint; she has been feeling unwell and not her normal self for 4 days now; she had 1 dizzy spell; This is a spontaneous report from a Pfizer sponsored program by a contactable consumer reported for self. This 84-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Feb2021 at single dose for covid-19 immunisation. Yesterday, 23Feb2021, she had 1 dizzy spell; she sat down and the dizziness went away within seconds. She states it felt like she may faint. She states she has been feeling unwell and not her normal self for 4 days now. She's wondering if this is a serious side effect, if she should still get the second dose, and how long do the symptoms last. Outcome of the event 1 dizzy spell was recovered on 23Feb2021. Outcome of the event feeling unwell was not recovered. Outcome of another event was unknown. Information on Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/23/2021,3.0,UNK,,,,,,"['Dizziness', 'Malaise', 'Syncope']",1,PFIZER\BIONTECH, 1091675,IN,80.0,F,"Myocarditis/had another virus that went to her heart; trouble remembering; incredible fatigue; could sleep around the clock; brain fog; This is a spontaneous report from a contactable nurse (Patient). An 80-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), intramuscular at Right Deltoid from on 16Feb2021 11:00 at single dose for covid-19 immunisation. Medical history included stomach was burning, heartburn, low thyroid, myocarditis and was hospitalized a year ago, Milroy's disease, and low potassium, heart disorder and Back disorder. Concomitant medications included bumetanide (BUMEX) Has been taking for about 40 years for Milroy's disease, rosuvastatin calcium (CRESTOR) from Jan2020 for Myocarditis, levothyroxine Has been taking for 40 years for low thyroid, tramadol Started about 10-12 years ago for back, metoprolol from Jan2020 for heart, omeprazole (PROTONIX) Started taking about 8 years ago for stomach was burning and heartburn, potassium Has taken for 40-50 years for low potassium, vitamin B12, vitamin D3 and baby aspirin 81mg, all were ongoing. The patient received first dose of BNT162B2 (lot number: EL8982) on an unknown date for covid-19 immunization and she got a really sore arm. The patient experienced Myocarditis/had another virus that went to her heart on an unspecified date, brain fog on 17Feb2021, trouble remembering on an unspecified date, incredible fatigue on 17Feb2021, could sleep around the clock on 17Feb2021. The clinical course as following: injection was on 16Feb2021. She has had incredible fatigue. She was asking how long is the fatigue going to last. She knows it is a side effect but she could sleep around the clock. She stated she goes to bed at 6PM if not before then and gets up at around 8AM and by 9AM she could go back to bed. She is sorry she got the shot because she is miserable. She mentioned she has been reading up on the vaccine and it said ""you might have fatigue for a day or two"". Her fatigue has now been 8 days. She thought ""how long is this going to go on"". Patient reported that with the first shot she got a really sore arm. Stated she thinks the person giving the injection put the darn thing through her bone. She thought it was to be expected, but it feels like the person who administered the vaccine was a poor shot giver. She provides the first Covid Vaccine Lot number: EL8982. With the second shot her arm did not get sore at all. The only thing she's having was the fatigue, she can hardly walk past her bed without wanting to get back in it. She tries to get up to shower and fix her hair and be motivated and she's been fighting the fatigue all day to not get back in bed. When probed for the seriousness criteria of the fatigue, the caller explains she doesn't think it's that significant. She thought it will go away. However, she was just coming out of myocarditis. She was just in the hospital for myocarditis and they did a heart cath and she has no plugged arteries, nothing. They couldn't find anything other than she had another virus that went to her heart. She had another virus a year ago January. She wonders if COVID was out there then, because she had never been so sick with the flu. She kind of diagnosed her problem and it was like a wave over her body. She also had a terrible irregular pulse. When she went to the hospital the next morning, her cardiac enzymes were 4.5 times more than normal, her troponin was out of sight. She doesn't think that would have a bearing because she should be coming out of that myocarditis because of the medication the doctor put her on. She doesn't know if that would complicate it, too. Her heart doctor said a lot of people have myocarditis, especially athletes, but they are young and fall over dead. 90% of the time, its myocarditis because you don't know you have it. She reports she's getting a foggy brain. Her son asked her who her dentist was because she had a root canal and she couldn't think of the dentist's name. She thinks her son threw that in because her son knew that she wouldn't be able to remember. She's not confused. It's just difficult to get the word out, but if she waits a couple minutes, she has the answer. She is also getting old, too. She lives by herself; she has no stimulation and she thinks that is significant to her circumstances. She thinks it's a problem with the COVID-19 injection. Caller explains she had blood work very recently about 2 weeks ago. She just looked at lab reports and everything was okay except one of the vitamins was a tiny bit high (she can't remember what the vitamin was), but nothing she was worried about. It could have been a Potassium was a little high, but she is not worried about that. Her main question is how long the fatigue last, she thought for only 1-2 days. She mentions she took her temperature every morning and its always like 97 something and it's never wavered. The outcome of the events brain fog, incredible fatigue, and could sleep around the clock was not recovered and the outcome of the other events was unknown.; Sender's Comments: Based on the information provided, viral myocarditis is most likely due to a viral infection in this patient with cardiovascular co-morbidities and is not related to suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. This case will be reassessed upon receipt of additional information.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/16/2021,02/17/2021,1.0,PVT,BUMEX; CRESTOR; LEVOTHYROXINE; TRAMADOL; METOPROLOL; PROTONIX [OMEPRAZOLE]; POTASSIUM; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D3; BABY ASPIRIN,,Medical History/Concurrent Conditions: Back disorder; Dyspepsia; Heart disorder; Milroy's disease; Myocarditis (She has a history of myocarditis and was hospitalized a year ago.); Potassium low; Thyroid function decreased,,,"['Blood potassium', 'Blood test', 'Body temperature', 'Fatigue', 'Feeling abnormal', 'Memory impairment', 'Myocardial necrosis marker', 'Somnolence', 'Troponin', 'Viral myocarditis']",2,PFIZER\BIONTECH,OT 1091676,CA,74.0,F,"optical neuritis; inability to move, chew, eat, etc.; inability to move, chew, eat, etc.; neurological damage; unable to speak; changes in her eyes; Her right eye was bulging; Neither eye looked in the same direction, or able to track objects; known allergies: Apparently the Covid Vaccine by Pfizer; This is a spontaneous report from a contactable consumer. The consumer reported two reports for two separate vaccine doses for the same patient. This is the first of two reports. A 74-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. Medical history included advanced stages of Multiple Sclerosis, Diabetes, depressant, covid prior vaccination. The patient's concomitant medications included diabetic meds (pills), anti-depressants, etc. The patient previously received the first dose of BNT162B2 in Dec2020 at age of 74 years old for COVID-19 immunization and experienced neurological setback and it wasn't terribly obvious at that time. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. The patient (mother of the reporter) suffered a neurological setback following the first injection, although it wasn't terribly obvious at that time, in comparison to what occurred after she received the second vaccine. The patient suffered major neurological damage after the second vaccine; unable to speak, followed by an inability to move, chew, eat, etc. The reporter also noticed optical neuritis or changes in her eyes. Her right eye was bulging. Neither eye looked in the same direction, or able to track objects. The patient was currently in a long term acute hospital (pending clarification) with a tracheostomy and a food peg. She had advanced stages of Multiple Sclerosis. Reporter had since learned she had been advised by her MS doctors NOT to receive flu shots. The reporter had known this and would not have listened to the doctors at the nursing home, who recommended she receive the Covid Vaccine. This was serious. The reporter was awaiting medical records, which would provide exact dates, times, etc of the administration of the vaccines. Adverse events resulted in Disability or permanent damage. Known allergies: Apparently the Covid Vaccine by Pfizer. If treatment adverse events: unknown. The outcome of the events was not recovered. The patient underwent lab tests and procedures which included unknown covid test: negative in Jan2021 (post vaccination). The outcome of the events was not recovered. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/28/2021,,,SEN,,,Medical History/Concurrent Conditions: COVID-19 (covid prior vaccination); Depression; Diabetes; Multiple sclerosis,,,"['Allergy to vaccine', 'Dysarthria', 'Exophthalmos', 'Eye disorder', 'Eye movement disorder', 'Mastication disorder', 'Nervous system disorder', 'Optic neuritis', 'Paralysis', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1091677,OH,42.0,M,PATIENT RECEIVED SHOT ON 2/25/2021 AND ON 3/7/2020 PT STARTED SHOWING SIGNS OF BELL'S PALSEY,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/25/2021,03/07/2021,10.0,PUB,NONE,NONE,DIABETES MELLITUS,,NONE,"[""Bell's palsy""]",UNK,PFIZER\BIONTECH, 1091695,IL,78.0,F,patient expired 2/10/2021. Unknown whether the death was even related to the vaccine. Pt did not have any problems during 15 min observation period and no issues reported to HD after vaccination. reported because the person expired within 7 days of vaccination.,Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/10/2021,7.0,PUB,unknown,unknown,unknown,,no allergies identifiied,['Death'],1,MODERNA,IM 1091703,VA,78.0,M,sudden shortness of breath,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/05/2021,02/19/2021,14.0,PVT,Medrol dose pack Lipitor voltaren gel meloxicam,back pain,HTN spinal stenosis bladder cancer,,erythromycin,['Dyspnoea'],UNK,MODERNA, 1091717,CA,31.0,F,"3/5: Had hematoma on the tongue, inside mouth, gums and over the body 3/6 am: platelets was 3, diagnosed as ITP, given steroids + platelets transfusion, platelets to 33 right after 3/7: platelets dropped to 8 in the morning, and then started steroids and 2nd platelets transfusion and IVIG, checked after, platelets 54, but random glucose 285, given 3 units insulin 3/8: platelets remained at 54, given steroids and 2nd IVIG 3/9 am checked platelets at 84, discharged",Not Reported,,Yes,Yes,4.0,Not Reported,Y,02/24/2021,03/05/2021,9.0,PVT,,,,,,"['Blood glucose increased', 'Immune thrombocytopenia', 'Immunoglobulin therapy', 'Oral mucosa haematoma', 'Platelet count decreased', 'Platelet transfusion', 'Tongue haematoma']",1,MODERNA,SYR 1091753,IL,68.0,M,observed for 15 min after both vaccines and no reported issues after vaccination. Patient did expire 2/25/2021 but cause of death unknown.,Yes,02/25/2021,Not Reported,Not Reported,,Not Reported,N,02/24/2021,02/25/2021,1.0,PUB,was on warfarin but other medications unknown,unknown,unknown,,allergy to sulfa,['Death'],2,MODERNA,IM 1091763,AZ,68.0,M,"Pt admitted to hospital <24 hours after receiving dose #1 COVID-19 Moderna vaccine with abdominal pain, nausea/ vomiting, dyspnea, generalized myalgias and arthralgias.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/20/2021,02/21/2021,1.0,PVT,"Albuterol inhaler, amlodipine, aspirin, atorvastatin, buspirone, carvedilol, clonazepam, gabapentin, sitagliptin, insulin glargine, lisinopril, naproxen, pantoprazole, risperidone, trazodone, venlafaxine",,"Type 2 diabetes, Hypertension, bipolar disorder,",,"divalproex, metformin, penicillins","['Abdominal pain', 'Arthralgia', 'Dyspnoea', 'Myalgia', 'Nausea', 'Vomiting']",UNK,MODERNA, 1091799,KY,64.0,M,"Became COVID-positive, pneumonia, ARDS, hospitalized for hypoxia 2/21/2021, death 2/25/2021",Yes,02/25/2021,Not Reported,Yes,4.0,Not Reported,N,01/12/2021,02/25/2021,44.0,SEN,"Lactobacillus Acidophilus (Acidophilus Lactobacilli) 1 Each Capsule, 1 CAPSULE PO QID, #100 CAPSULE 0 Refills 9/14/19 Sulfamethoxazole/Trimethoprim (Sulfamethoxazole-Tmp Ds Tablet) 1 Each Tablet, 1 EACH PO Q12 for 8 Days, #16 TAB 0 Refills",UTI,"cardiovascular disease, hypertension, type 2 diabetes, hyperlipidemia, Alzheimer's disease, chronic kidney disease, hypothyroidism, depression, anxiety, PVD, frequent UTIs, anorexia, GERD, osteoporosis",,none listed,"['Acute respiratory distress syndrome', 'Alanine aminotransferase normal', 'Anion gap', 'Anisocytosis', 'Aspartate aminotransferase increased', 'Band neutrophil percentage increased', 'Base excess increased', 'Basophil count decreased', 'Basophil percentage decreased', 'Blood albumin decreased', 'Blood alkaline phosphatase increased', 'Blood bicarbonate increased', 'Blood bilirubin normal', 'Blood calcium decreased', 'Blood chloride normal', 'Blood creatinine increased', 'Blood glucose normal', 'Blood lactate dehydrogenase increased', 'Blood lactic acid', 'Blood magnesium normal', 'Blood pH normal', 'Blood parathyroid hormone increased', 'Blood phosphorus increased', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea increased', 'Blood urea nitrogen/creatinine ratio', 'C-reactive protein increased', 'COVID-19', 'Carbon dioxide normal', 'Death', 'Eosinophil count decreased', 'Eosinophil percentage decreased', 'Fibrin D dimer increased', 'Fraction of inspired oxygen', 'Glomerular filtration rate decreased', 'Haematocrit decreased', 'Haemoglobin decreased', 'Hepatitis A antibody negative', 'Hepatitis B core antibody negative', 'Hepatitis B surface antigen negative', 'Hepatitis C antibody negative', 'Hypochromasia', 'Hypoxia', 'Immature granulocyte count', 'Laboratory test', 'Lymphocyte count decreased', 'Lymphocyte percentage decreased', 'Mean cell haemoglobin concentration decreased', 'Mean cell haemoglobin decreased', 'Mean cell volume normal', 'Mean platelet volume normal', 'Monocyte count normal', 'Monocyte percentage decreased', 'N-terminal prohormone brain natriuretic peptide increased', 'Neutrophil count increased', 'Neutrophil percentage increased', 'Oxygen saturation', 'PCO2 increased', 'PO2 decreased', 'Platelet count normal', 'Pneumonia', 'Polychromasia', 'Procalcitonin increased', 'Protein total increased', 'Punctate basophilia', 'Red blood cell count decreased', 'Red blood cell nucleated morphology present', 'Red cell distribution width increased', 'SARS-CoV-2 test positive', 'Serum ferritin increased', 'Troponin I normal', 'White blood cell count normal']",1,PFIZER\BIONTECH,IM 1091813,OH,62.0,F,"Patient arrived to the outpatient vaccine clinic for her scheduled appointment. Immediately after receiving the vaccine, the patient felt chest pain, dizziness, and passed out. She had swelling of the tongue, lips, eyes, and throat. Patient was admitted to the hospital and treated for anaphylaxis with epinephrine, benadryl, famotidine, methylprednisolone, Duoneb and tylenol. Patient is currently still in the hospital but her condition is stable.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,03/10/2021,03/10/2021,0.0,PVT,amlodipine fluoxetine hydrochlorothiazide levothyroxine losartan metoprolol succinate mirtazapine Percocet Xtampza Lyrica Chantix Tylenol,,"hypertension, acquired hypothyroidism, fibromyalgia",,contrast dye,"['Anaphylactic reaction', 'Chest pain', 'Dizziness', 'Eye swelling', 'Immediate post-injection reaction', 'Lip swelling', 'Loss of consciousness', 'Pharyngeal swelling', 'Swollen tongue']",1,JANSSEN,IM 1091815,NV,62.0,M,"After my vaccine, I went to the hospital because I experienced weakness some shortness of breath and some tremors. I am a doctor of training, one aspect the aspect of covid-19 affects testosterone. I got Covid after my first dose. I am still having some symptoms and scheduled to return back to work the third week of March 2021.",Not Reported,,Not Reported,Yes,30.0,Not Reported,N,12/30/2020,01/08/2021,9.0,PVT,alodipem,none,none,,none,"['Asthenia', 'COVID-19', 'Computerised tomogram', 'Dyspnoea', 'Laboratory test', 'Tremor', 'X-ray']",1,PFIZER\BIONTECH,IM 1091828,NE,91.0,F,"As reported by son and by DON of Medical Center: 02.06.2021 Son reports that patient had spoken with her daughter the morning of 02.06 via phone and that patient sounded fine. Patient's son tried to call her around 3:30 or 4 and there was no answer. Son called the facility where patient resided and staff went to check on her, where they found patient on the floor, conscious. Patient was communicating fine when they found her. It is unclear if she bumped her head when she fell, but patient deteriorated and was taken to ER where a CT was done and it was determined patient had a brain bleed as well as a UTI. Patient was admitted to hospital. Patient subsequently had a stroke while in hospital. Patient was discharged to rehab facility on 02.23.2021 and while she has regained the ability to walk with a walker and some use of her right hand, she remains unable to speak.",Not Reported,,Yes,Yes,18.0,Yes,N,02/05/2021,02/06/2021,1.0,SEN,"Aspirin 81 mg EC tablet, calcium carbonate-vitamin D3 600 mg, calcium 200 unit Cap, clopidogrel 75 mg tablet, desonide 0.05% cream, iosartan 50 mg, metroprolol 100 mg, multivitamin oral, pantoprazole 40 mg tablet, pravastatin 20 mg tablet,",UTI at time of admission to hospital on 02.06.2021,Recurrent UTIs.,,"None, per son.","['Cerebral haemorrhage', 'Cerebrovascular accident', 'Computerised tomogram head abnormal', 'Culture urine', 'Fall', 'General physical health deterioration', 'Urinary tract infection', 'Urine analysis', 'Walking aid user']",2,MODERNA,IM 1091856,OH,66.0,F,Caller says the the pt started having really bad headache the day after taking the vax that lasted about a week and half. She had 4 hours of amnesia. Pts husband took her to Hospital ER where she had a brain scan and was diagnosed w/ TGA and then admitted.,Not Reported,,Yes,Yes,,Yes,N,,,,UNK,estrace vaginal cream and Flonase spray,no,none,,ciprofloxacin,"['Amnesia', 'Computerised tomogram head', 'Headache', 'Transient global amnesia']",1,PFIZER\BIONTECH, 1091864,FL,59.0,M,"Patient received the 1st dose of the Pfizer Covid vaccine this morning, within 30 min started to experience stridor, wheezing and tongue numbness. EMS called and pt was given Solumedrol, Benadryl, and IM Epinephrine in route to the hospital. Pt was subsequently intubated in the ED and transferred to the ICU.",Not Reported,,Yes,Yes,1.0,Not Reported,U,03/11/2021,03/11/2021,0.0,PVT,Unknown,unknown,unknown,,Alteplase-angioedema PNC-unknown reaction,"['Endotracheal intubation', 'Hypoaesthesia oral', 'Intensive care', 'Laboratory test normal', 'Stridor', 'Wheezing']",1,PFIZER\BIONTECH, 1091869,MN,33.0,M,"First time seizure, normal MRI and EEG on workup",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/27/2021,03/09/2021,10.0,UNK,none,none,none,,none,"['Electroencephalogram normal', 'Laboratory test normal', 'Magnetic resonance imaging normal', 'Seizure']",UNK,PFIZER\BIONTECH, 1091877,TN,60.0,M,Patient became hypoxic with chest pain. Wheezing noted throughout lung fields. SPO2 80% on room air. Tachycardic 115 with decreased level of consciousness. Admitted to hospital with diagnosis of COPD exacerbation with Hyperkalemia (6.2). Currently stabilized on O2 at 3l/m,Not Reported,,Yes,Yes,2.0,Not Reported,Y,03/09/2021,03/10/2021,1.0,OTH,"flexeril, multivitamin, novolin-R/100, novolin70/30, odefsey, gabapentin, lactulose, metformin, albuterol, flomax, celexa, loxitane, cymbalta, simethicone, mag citrate, colace, metroprolol, aspirin","COPD, HIV, Neuropathy, CAD with stent placement, DM type II, BPH, PTSD, Anxiety, Constipation","COPD, HIV, Neuropathy, CAD with stent placement, DM type II, BPH, PTSD, Anxiety, Constipation",,Sulfa,"['Chest pain', 'Chronic obstructive pulmonary disease', 'Depressed level of consciousness', 'Hyperkalaemia', 'Hypoxia', 'Tachycardia', 'Wheezing']",1,JANSSEN,IM 1091894,HI,70.0,F,"The patient presented to the off complaining of feeling weak in the legs on Monday, March 1, 2021. She had been moving over the weekend and was over-exerting herself and stated she had fallen on a rug at the old house and then had lain down on the floor to sleep with her dog in the new home, had difficulty getting up and needed help. No symptoms of fever, chills, sweats, headache, myalgias. The next day she passed away at her home, sitting in her chair.",Yes,03/02/2021,Not Reported,Not Reported,,Not Reported,N,02/25/2021,03/01/2021,4.0,PVT,"atenolol, atorvastatin, lisinopril, furosemide, fluticasone-salmeterol, gabapentin, DuoNeb","Congestive heart failure, COPD, hypertension, peripheral edema","Congestive heart failure, COPD, hypertension, chronic kidney disease stage III, peripheral edema",,"Lovastatin, dust, keawa flower","['Death', 'Dysstasia', 'Fall', 'Muscular weakness']",1,MODERNA,IM 1091902,IN,70.0,M,"Major arm pain and UNABLE to lift the arm higher than my shoulder. SAME REACTION AS THE ONE I AM STILL SUFFERING FROM, WHICH WAS BROUGHT ON BY THE FIRST INJECTION IN THE OTHER ARM!!!!!!! I CANNOT LIFT MY ARMS!!!!!!",Not Reported,,Not Reported,Not Reported,,Yes,N,03/08/2021,03/08/2021,0.0,OTH,None,Nonw,Mild Type 2 Diabetes,,None,"['Injected limb mobility decreased', 'Pain in extremity', 'Vaccine positive rechallenge']",2,PFIZER\BIONTECH,IM 1091908,IL,83.0,M,"DVT blood clot in the right foot, then spread to lower leg and knee and thigh, groin",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/27/2021,02/12/2021,16.0,PHM,"Irbersartan, lovastatin, tricor, xyzal, cymbalata, and metformin.",None,"Diabetes, high chloesterol and high blood pressure,",,None,"['Deep vein thrombosis', 'Ultrasound scan']",2,PFIZER\BIONTECH,IM 1091924,IL,51.0,M,"51 y.o. male from Facility. The patient was seen at his primary care physician's office for some left facial swelling. Apparently, he started getting more short of breath while he was there. He was sent in by EMS. His sats were initially in the upper 80s at his primary care physician's office. He denies any symptoms of URI, but does state he has a long history of COPD. The patient was given some DuoNebs and supplemental oxygen in the emergency room and shortness of breath basically resolved. However, he did have very significant left facial swelling. His CT did show facial cellulitis with possible abscess, but no fluid collection. His white blood cell count was almost 25. He had been having fevers at home. Because of all this the decision was made to admit for IV antibiotics. � When I saw the patient, he was willing to stay for IV antibiotics for a few days. 3/11/21 remains hospitalized",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,03/04/2021,03/10/2021,6.0,PUB,"Current Outpatient Medications: ? amLODIPine (NORVASC) 10 MG tablet, Take 1 Tab (10 mg) by mouth daily, Disp: 30 Tab, Rfl: 3 ? carBAMazepine (TEGRETOL) 200 MG tablet, TAKES 3 TABLETS (600 MG) BID, Disp: 180 Tab, Rfl: 3 ? lisinopril (PRI",,,,nka,"['Alanine aminotransferase normal', 'Aspartate aminotransferase normal', 'Blood albumin decreased', 'Blood alkaline phosphatase normal', 'Blood bilirubin normal', 'Blood calcium decreased', 'Blood chloride decreased', 'Blood creatinine normal', 'Blood glucose increased', 'Blood lactic acid normal', 'Blood potassium normal', 'Blood sodium decreased', 'Blood urea decreased', 'Blood urine present', 'Carbon dioxide normal', 'Cellulitis', 'Chest X-ray abnormal', 'Chronic obstructive pulmonary disease', 'Computerised tomogram head abnormal', 'Computerised tomogram neck', 'Condition aggravated', 'Dyspnoea', 'Full blood count', 'Gingival discolouration', 'Gingival erythema', 'Gingival swelling', 'Haematocrit decreased', 'Haemoglobin decreased', 'Hyponatraemia', 'Mean cell volume normal', 'Nitrite urine absent', 'Platelet count normal', 'Protein urine present', 'Pulmonary fibrosis', 'Pyrexia', 'Red blood cell count normal', 'Red blood cells urine', 'Specific gravity urine normal', 'Swelling face', 'Tooth abscess', 'Urine analysis abnormal', 'Urine ketone body absent', 'Urine leukocyte esterase', 'White blood cell count increased', 'White blood cells urine negative', 'pH urine normal']",2,MODERNA,IM 1091928,ID,80.0,M,Pt was given Moderna COVID-19 vaccine on 2/11/21 with no adverse reactions. Pt later died on 3/08/2021 with lung cancer being cause of death.,Yes,03/08/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,03/08/2021,25.0,PVT,,Lung cancer,,,,"['Death', 'Lung neoplasm malignant', 'No adverse event']",1,MODERNA,IM 1091936,NY,39.0,F,"45min post 1st moderna covid vac developed rash across chest, throat tightness, pt self administered epi pen",Not Reported,,Yes,Not Reported,,Not Reported,Y,03/11/2021,03/11/2021,0.0,PUB,,,Ehlers-Danlos,,"bell pepper,nsaids, divalproex, carbamazepone, capsaicin, cephalexin, erythromycin, clindamycin, chlorhexidine,lamotrigine","['Complement factor C3', 'Cytokine test', 'Full blood count', 'Metabolic function test', 'Rash', 'SARS-CoV-2 antibody test', 'Throat tightness', 'Total complement activity test', 'Tryptase']",1,MODERNA,IM 1091957,CO,77.0,M,"I'm still not sure which COVID19 vaccine my dad received (It made me fill it out--I'm not sure if he got Moderna or Pfizer). Nursing home would know. He received his 2nd shot on Jan 19. On Feb 17 all was fine and they were planning on getting him crowns at the dentist. On Feb. 19 everything went poorly. He started to suddenly have seizures and was not responsive. When I arrived on Feb 21 he didn't say much and had seizures that night. On Feb 22, he responded a little bit and had a big black eye from a seizure the night before. On Feb 22 he had at least 4 seizures and he passed that afternoon around 1:20 pm",Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,02/19/2021,31.0,SEN,My dad had a whole list of medications that Nursing home would have,Diabetes Gout,,,,"['Death', 'Eye contusion', 'Seizure', 'Unresponsive to stimuli']",UNK,MODERNA, 1091959,MO,64.0,F,"Patient is a 64 y.o. female admitted for acute DKA, glucose is 771 Severe ketoacidosis, bicarb is only 7 AKI, pseudohyponatremia K 5.3 LFT's ok Got the covid 19 vaccine 2 days ago She has sore throat and chills She did vomit up coffee ground material",Not Reported,,Not Reported,Yes,,Not Reported,U,03/09/2021,03/10/2021,1.0,PVT,"PTA meds: Atorvastatin, Cetirizine, Fluticasone nasal spray, insulin degludec, insulin lispro, lactobacillus, levothyroxine, losartan-hydrochlorothiazide, naproxen.",None reported in notes.,"Essential hypertension, T1DM, hypercholesterolemia, polyneuropathy in diabetes.",,Ramipril - causes angioedema,"['Acute kidney injury', 'Blood bicarbonate decreased', 'Blood glucose increased', 'Blood potassium increased', 'Chills', 'Diabetic ketoacidosis', 'Haematemesis', 'Liver function test normal', 'Oropharyngeal pain', 'Pseudohyponatraemia']",1,PFIZER\BIONTECH,IM 1091963,RI,74.0,F,"Day after shot severe fatigue, loss of balance, dropping things[. Hand Tremors, headaches, dizzyness, raspy voice, shoulder pain, shortness of breath.",Not Reported,,Not Reported,Yes,3.0,Yes,U,02/10/2021,02/11/2021,1.0,PUB,"Atorvastatin, BaDAGLAR iNSULIN, ERGOCALCIFEROL, OMEPRAZOLE, VENLAFAXINE AND QUINAPRIL",None,"Diabetic, High Blood Pressure, Fibromialyia, Neck Pain from Vertebraes",,None,"['Arthralgia', 'Balance disorder', 'Dizziness', 'Dysphonia', 'Dyspnoea', 'Fatigue', 'Grip strength decreased', 'Headache', 'Laboratory test', 'Tremor']",2,MODERNA,IM 1091990,MO,67.0,F,"On 3/4 patient received 1st dose of COVID vaccination. She states that she drove home afterward and decided to sit and watch TV. She immediately began noticing that the words on her TV screen were not legible - her vision had become blurry. This blurriness was accompanied by severe eye pain and pain in the temples of her head. When shutting eyes and keeping them closed for a few hours, the blurriness would subside. However she continues to experience this blurriness 'on and off' to date. Also experienced some mild headaches but they have subsided as of two days ago. Hasn't taken anything to alleviate the symptoms. Patient is extremely concerned that she may permanently lose vision and refuses to get 2nd dose.",Not Reported,,Not Reported,Not Reported,,Yes,N,03/04/2021,03/04/2021,0.0,PUB,"Aliskiren, amitriptyline, atorvastatin, baclofen, betaseron",,"Type 2 DM, Asthma, GERD, Migraines, HTN, Multiple Sclerosis, Hyperlipidemia, Allergic Rhinitis",,"Fentanyl, Sulfonamide Antibiotics","['Eye pain', 'Headache', 'Vision blurred']",1,PFIZER\BIONTECH,IM 1092016,NE,87.0,F,"Per son and employee, patient's health had been declining since she was hospitalized for a severe UTI in Dec 2020. The evening of 02.09.2021 she vomited, then was found to be unresponsive the morning of 02.10.2021. Patient passed away later in the day on 02.10.2021.",Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/09/2021,4.0,SEN,"Acetaminophen 325 mg, 2 every 4 hours, Allevyn Adhesive Pad (wound dressings), atorvastatin calcium 10mg, diphenhydramine HCl 25 mg, cefdinir 300 mg, digoxin 125 mcg, ellquis tablet 5 mg, levothyroxine sodium tablet 112 mcg, megace oral sus","Severe UTI, dementia.","T2 diabetes mellitus, essential hypertension, chronic a-fib, osteoarthritis, malignant neoplasm of breast, hypothyroidism, hyperlipidemia",,Bactrim,"['Death', 'General physical health deterioration', 'Unresponsive to stimuli', 'Vomiting']",2,MODERNA,UN 1092042,CO,78.0,M,"Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic reporting body aches, heaches, and chills since receiving vaccination five days prior. No shortness of breath, chest pain, vomiting, or diarrhea. Patient was not in distress or ill-appearing: normal breath sounds (no wheezing, rhonchi, or rales). Five days after clinic visit (ten days after vaccination) patient's wife and daughter reported patient had poor appetite and feeling worse since clinic visit: weakness, pain all over, decreased oral intake, and cough with phlegm. Advised to go to the emergency room immediately. Patient's daughter reported the next day patient admitted to another facility and COVID-19 test was positive.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/26/2021,03/08/2021,10.0,PVT,"colchicine, indomethacin, terbinafine",gout attack,"hyperlipidemia, type 2 diabetes mellitus, inguinal hernia, benign prostatic hyperplasia, gout",,tetracycline,"['Asthenia', 'COVID-19', 'Chills', 'Decreased appetite', 'Headache', 'Hypophagia', 'Pain', 'Productive cough', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1092047,MN,80.0,F,patient passed away within 60 days of receiving a COVID vaccine,Yes,02/18/2021,Not Reported,Not Reported,,Not Reported,,01/07/2021,02/18/2021,42.0,SEN,,,,,,['Death'],UNK,MODERNA, 1092108,NE,83.0,M,"Patient's wife reports patient never reported feeling unwell. He had been working on painting the basement all week and on 02.12.2021 came in from outside, ate, and they sat down to watch TV. Around 9:30 patient reported being extremely tired and went to bed. Was found unresponsive the following morning, 02.13.2021. Patient's wife reports the doctor said it was a heart attack.",Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/13/2021,2.0,OTH,Metoprolol,None,None (had prior heart surgery two times.),,None,"['Fatigue', 'Malaise', 'Myocardial infarction', 'Unresponsive to stimuli']",1,MODERNA,IM 1092110,MN,78.0,M,Patient passed away within 60 days of receiving a COVID vaccine series,Yes,03/06/2021,Not Reported,Not Reported,,Not Reported,,02/04/2021,03/06/2021,30.0,SEN,,,,,,['Death'],UNK,MODERNA, 1092168,MN,91.0,M,Patient passed away within 60 days of receiving a COVID vaccine,Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,,01/31/2021,02/12/2021,12.0,SEN,,,,,,['Death'],1,MODERNA, 1092171,,67.0,M,"March 7: After 3-4 days or worsening dyspnea, pt requested ambulance transport to our ED. Upon arrival, pt was very SOB so full workup ensued. Pt was found to have elevated BTNP at 2240 pg/ml with fluid overload, and Biofire Respiratory Panel showed Coronavirus PCR positive. At that time, his COVID markers were also elevated. CRP 91.4 mg/L, D-Dimer 2340 ng/mL. Patient was admitted, diuresed, and started on inpatient COVID protocol which included Ivermectin. March 9: EKG was performed and patient was found to have a heart block. All labs had improved over the past 48 hrs. BTNP reduced to 1530, D-Dimer reduced to 1700, CRP reduced to 47.9. Due to the heart block, patient was transferred to a care center to a cardiologist. Just prior to transfer, a follow up Biofire respiratory panel showed Coronavirus PCR NEGATIVE. PCR positive and negative results were relayed to accepting facility - facility and they were going to refer to epidemiology for follow up.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/09/2021,03/07/2021,26.0,PVT,Apixaban 2.5 bid ASA 81 daily Atorvastatin 10 qhs Calcium Carb/Vit D tid DSS 100 bid prn Famotidine 20 qhs Insluin Glargine 30 units qhs Insulin Lispro 10 units AC Oxycodone 15 mg q 4 hrs prn,Unknown,Coronary Artery Disease Diabetes Mellitus Type II Hypertension Hyperlipidemia Peripheral Artery Disease - BKA of RLL GERD,,PCN (childhood allergy - does not know reaction) Simvastatin,"['Atrioventricular block', 'C-reactive protein increased', 'Dyspnoea', 'Electrocardiogram abnormal', 'Fibrin D dimer increased', 'Fluid overload', 'N-terminal prohormone brain natriuretic peptide increased', 'Polyuria', 'Respiratory viral panel', 'SARS-CoV-2 test positive']",2,MODERNA,IM 1092183,MI,59.0,F,"Patient had dizziness after receiving vaccine. Evaluated by clinic staff - then reporting throat tightness and reported having left shoulder pain for the prior 1.5 hours. patient was sent to the ED by EMS. The pt states that she had her first covid vaccine injection today and less than 30 minutes after her vaccine she developed acute central chest pain radiating to her left shoulder. She was given a full dose asa and 1 SL nitro by EMS. She states her chest pain was a 9/10 and it was pressure and tightness. She had associated lightheadedness. She states her pain is much worse than her typical chest pain she gets at home and takes nitro for. She states she is unsure if it is exertional, it is not worsened by deep breathing or palpation. She denies syncope, facial swelling, diaphoresis, n/v, abdominal pain, and hx of allergic reactions from vaccines.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,03/09/2021,03/09/2021,0.0,OTH,"albuterol, asa 81 mg, QVAR 80 mcg, plavix 75 mg, novolog flexpen, novolin N, humulin N, lidoderm, prinivil, aciphex",,"HTN, hyperlipidemia, CAD, hx alcoholism, hx drug abuse, anorexia, bulimia, type 1 diabetes with neuropathy, myopia",,"amlodipine - dizziness, isosorbide - dizziness iodinated contrast - hives atorvastatine, bee venom, erythromycin, insulin glargine, keflex, latex, levemir, lorabid, penicillin's, sulfa drugs, tetracycline","['Arthralgia', 'Blood glucose increased', 'Chest X-ray normal', 'Chest discomfort', 'Chest pain', 'Condition aggravated', 'Dizziness', 'Electrocardiogram normal', 'Full blood count', 'Metabolic function test', 'Pain', 'Platelet count decreased', 'Throat tightness', 'Troponin normal']",1,PFIZER\BIONTECH,IM 1092194,MD,58.0,F,"2/27. Spontaneous subdural hematoma. Occurred 30 minutes into a flight. Headache and dizziness began one week prior to 2/27, but not sure if they are correlated.",Not Reported,,Not Reported,Yes,6.0,Not Reported,N,01/21/2021,02/27/2021,37.0,PVT,Senimet; Selegiline,,Parkinson's,,,"['Angiogram', 'Computerised tomogram', 'Dizziness', 'Headache', 'Magnetic resonance imaging', 'Subdural haematoma']",2,PFIZER\BIONTECH,IM 1092203,UT,67.0,M,"epidural hematoma/abscess- developed fevers, severe back pain, required OR evacuation of hematoma and spinal surgery, will require 6-8 weeks IV abx",Not Reported,,Not Reported,Yes,,Yes,N,02/20/2021,03/08/2021,16.0,PVT,"Apple Cider Vinegar, 1 oz, Oral, Daily atorvastatin 40 mg oral tablet, 40 mg= 1 tabs, Oral, Daily Centrum Silver, 1 tabs, Oral, Daily CoQ10, 1 cap, Oral, Daily famotidine 20 mg oral tablet, 20 mg= 1 tabs, Oral, Daily gabapentin 100 mg","epidural abscess/hematoma, pyelonephritis, sepsis,","Angina pectoris, unspecified Aortic atherosclerosis Atherosclerosis of iliac artery Bilateral foot pain Bilateral plantar fasciitis BPH (benign prostatic hyperplasia) BPH w urinary obs/LUTS Chronic back pain GERD (gastroesophageal reflux disease) Hyperlipidemia Low back pain Lumbar radiculopathy Multiple gastric polyps Other specified inflammatory spondylopathies, lumbar region Peripheral neuropathy Personal history of kidney stones Prediabetes Trigger finger of right thumb",,"naproxen, Tramadol, Septra","['Back pain', 'Bacterial test positive', 'Extradural abscess', 'Extradural haematoma', 'Haematoma evacuation', 'Magnetic resonance imaging spinal abnormal', 'Pyrexia', 'Spinal operation']",1,PFIZER\BIONTECH,SYR 1092214,ME,66.0,M,"Patient received his first COVID vaccine on 3/2 and then passed away 3 days after receiving Moderna vaccine. Provider presumed he died from sudden heart attack, this occurred at home.",Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/02/2021,03/05/2021,3.0,PVT,Tylenol Aspirin Atorvastatin Carvedilol Fish Oil Isosorbide Levemir Insulin Magnesium Metformin Novolog Insulin Omega 3 Potassium Chloride Ranolazine Sildenafil Torsemide Zetia,none documented,Hypertension Benign neoplastic disease microalbuminuric diabetic nephropathy coronary bypass graft atopic dermatitis angina pectoris acute injury of kidney hyperlipidemia diabetes Myocardial infarction Heart failure atherosclerosis aortic valve stenosis sleep apnea spinal stenosis erectile dysfunction,,Losartan Simvastatin Amlodipine,['Sudden cardiac death'],1,MODERNA,IM 1092231,TN,57.0,F,"Moderna COVID-19 Vaccine EUA 5 hours after getting my first vaccine I had a breathing crisis with my oxygen dropping into the low 60s. I have COPD and use home oxygen as well as portable on the rare occasion that I leave the house since COVID 19. I've also had a thoracotomy and thoracentesis in 2019. But my oxygen never drops that low. We turned up my oxygen, I used my rescue inhaler, and we started a breathing treatment. None of it was helping and I felt like I was suffocating. My husband called emergency services. The EMTs got me on oxygen with a face mask and gave me IV Magnesium in the ambulance. I was breathing better by the time we got to the ER. They gave me additional medications and oxygen there. They took a chest X-ray too, but said it looked clear.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PVT,"Alprazolam, Gabapentin, Sertraline, Seroquel, Pramipexole, Mirtazapine, Trazadone, Tramadol, Prednisone, Ipratropium Bromide, Levalbuterol, Levalbuterol Tartrate, Trelegy, Multi Vitamin, B Complex, Vitamin D3, Ferrous Sulfate",COPD,COPD,,"Peanuts, Morphine, Eugenol (dental crown cement)","['Chest X-ray normal', 'Dyspnoea', 'Oxygen saturation decreased', 'Suffocation feeling']",1,MODERNA,IM 1092235,CA,79.0,F,"2/26/21 History & Physical- History of present illness: ""Pleasant 79 years old female who started to develop recurrent episodes of nausea and vomiting of nonbilious none bloody material 1 week ago then started to have frequent watery bowel movements with the last bowel movement was associated with rectal bleeding, she started to develop generalized weakness and fatigue, she had 3 falls in the last week without hitting her head, she did not have loss of consciousness, over the last 2 days she has been complaining of numbness and tingling to the hands and feet, she was not able to walk due to generalized weakness. She denied fever or chills she had no chest pain or shortness of breath. 2 weeks ago she got her second dose of COVID-19 vaccine. There was no change to her medications according to her, she denies sick contacts."" Intubated and ICU transfer 2/28/21 for ""Possible Guillain-Barr� syndrome and impending respiratory failure"" extubated 3/10/21.",Not Reported,,Not Reported,Yes,12.0,Not Reported,N,02/13/2021,02/20/2021,7.0,OTH,"Actos 15mg, Propranolol 80mg, Metformin 1000mg, HCTZ 25mg, KCl 10mEq, Lipitor 10mg",Unknown,Hypertension Hyperlipidemia Diabetes mellitus type 2 Obesity,,Ampicillin - Rash,"['Angiogram cerebral normal', 'Arteriogram carotid normal', 'Asthenia', 'Bronchoscopy', 'Computerised tomogram abdomen abnormal', 'Computerised tomogram head normal', 'Computerised tomogram neck', 'Computerised tomogram pelvis abnormal', 'Diarrhoea', 'Endotracheal intubation', 'Fall', 'Fatigue', 'Frequent bowel movements', 'Gait inability', 'Guillain-Barre syndrome', 'Haematemesis', 'Hypoaesthesia', 'Intensive care', 'Intervertebral disc degeneration', 'Large intestine infection', 'Lumbar puncture normal', 'Magnetic resonance imaging spinal abnormal', 'Nausea', 'Paraesthesia', 'Plasmapheresis', 'Rectal haemorrhage', 'Respiratory failure', 'Scan with contrast abnormal', 'Spinal stenosis', 'Vertebral foraminal stenosis']",1,MODERNA,IM 1092316,VA,66.0,F,"Received report that client was admitted to the hospital on Feb 27th with persistent tachycardia. Called client on March 11 to inquire. Client shared that she has felt weak since having COVID-19 in September 2020 and was hospitalized for 3 months. She shared she has felt weak since having COVID-19. She shared that on the morning after receiving the vaccine she was getting out of her bed, which is on the floor, and she hit her head. She shared that her daughter was concerned and took her to the emergency department (ED). While there in the ED her blood work ?wasn?t right? and they thought she might have a small blood clot in her lung and she was admitted. While in the hospital she received eliquis which she had a reaction to. She shared she was in the hospital for 1 day. Recommended she see her PCP for these health concerns as well as before receiving the 2nd dose of a COVID-19/Moderna vaccine.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/26/2021,02/27/2021,1.0,PUB,,,Client reports having COVID-19 in September; was hospitalized for 3 months; Continues to feel weak; Has history of increased heart rate.,,,"['Blood test abnormal', 'Computerised tomogram', 'Head injury', 'Tachycardia']",1,MODERNA,IM 1092327,GA,79.0,F,"Day after receiving vaccine patient noted tightness in chest and difficulty breathing. Went to local urgent care and ambulance called to transport her to hospital as was feared a cardiovascular event. Admitted to Hospital, 02/12/21 and discharged 02/13/21. Patient states stress test, echo, and CT with contrast, and xrays all normal. She states hospital did not know what caused her symptoms and could not tell her if this was caused by vaccine. She followed up with her PCP on 02/15 and was told that by her xray it looked like she might have had the starting of something like bronchitis. Administered antibiotic shot and steroid shot and RX inhaler. Moderna COVID-19 vaccine EUA.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/11/2021,02/12/2021,1.0,PUB,Synthroid; Imitrex; Rosuvastatin; Focus 2 supp; Vit D,None,Neuropathy of feet; elevated cholesterol; osteoarthritis of spine; 4.3 aortic aneurysm,,None,"['Bronchitis', 'Cardiac stress test normal', 'Chest discomfort', 'Computerised tomogram normal', 'Dyspnoea', 'Echocardiogram normal', 'X-ray normal']",1,MODERNA,IM 1092340,,25.0,M,"No adverse reaction or allergic reaction in the 30 minutes following the vaccination. Also none in the 36 hours following the vaccination. Roughly 48 hours later, sensitivity to light and difficulty blinking one eye appeared along with severe headache. In the 24 hours following symptoms' first appearance, the entire left side of the face became numb and tingly with difficulty chewing, blinking, making any faces or smiling. Sound perceived from the left ear also changed. Subsequently diagnosed with Bell's Palsy on 03/10/2021.",Not Reported,,Not Reported,Not Reported,,Yes,N,03/07/2021,03/09/2021,2.0,PUB,None,Vertigo that lasted 3 days in the week prior to vaccination,None,,None,"[""Bell's palsy"", 'Deafness', 'Eyelid function disorder', 'Headache', 'Hypoaesthesia', 'Mastication disorder', 'Paraesthesia', 'Photophobia']",1,PFIZER\BIONTECH,SYR 1092401,FL,55.0,F,I was swimming in a lake when suddenly I couldn't breath and my heart started pounding. I was gasping for air. My pulse went from a normal working out pulse to above 145 bps. It did not come down when floating on my back or resting when I eventually got back into shore. Then when I got home I had to climb stairs and I lost my breath again.,Not Reported,,Yes,Yes,4.0,Not Reported,N,02/04/2021,02/28/2021,24.0,UNK,NP thyroid Metformin Omega 3 Vit D Multi vit Bio identical hormone replacement therapy Various medication for optimizing metabolism,,Descending T-wave on ekg the year prior thyroid disease. PCOS,,GLUTEN,"['Bundle branch block', 'Chest X-ray normal', 'Computerised tomogram thorax abnormal', 'Dyspnoea', 'Echocardiogram', 'Electrocardiogram abnormal', 'Heart rate increased', 'Magnetic resonance imaging heart', 'Palpitations', 'Pulmonary embolism', 'Scan with contrast']",2,MODERNA,IM 1092411,CA,59.0,F,"I began to feel ill on that Wednesday morning. I had had a bilateral mastectomy in Nov of 2020, and tissue expanders are still in place. I reached a fever of 103.6 and had pain and extreme redness in my right tissue expander. I also had all axillary lymph nodes removed from that side in December 2020. On Friday I was still feeling ill and noticed redness, so I immediately contacted my doctor and was instructed to meet him at the hospital. I was admitted and placed on antibiotics and had my tissue expander removed The next morning after no improvement from antibiotic infusion. I had a wound vac placed and stayed in the hospital for one week and had my expander replaced on that following Saturday. I am not planning on taking the second shot.",Not Reported,,Not Reported,Yes,8.0,Not Reported,Y,01/29/2021,02/03/2021,5.0,PVT,"Ropinerole, calcium, magnesium, zinc, multi vitamin",None,Breast cancer diagnosis 9/2020,,None known,"['Axillary lymphadenectomy', 'Breast operation', 'Breast pain', 'Erythema', 'Malaise', 'Pyrexia', 'Tissue expansion procedure', 'White blood cell count increased', 'Wound closure']",1,PFIZER\BIONTECH,IM 1092461,NY,36.0,F,"She got the Johnson & Johnson vaccine at Yankee stadium. Roughly 20 minutes after receiving the vaccine, she started to feel nauseous, develop crampy abdominal pain, and feel lightheaded. She went home and took a shower and lay down in bed. When she got up she again felt nauseous and dizzy. She threw up a total of 6 times, none of which were bloody. She had several episodes of diarrhea throughout the day. Given her ongoing symptoms she presented to the ED. � On arrival, she was febrile to 39.5C, and tachycardic to 145 with BP 98/56 and SpO2 100% on room air. She was given zofran, 1L NS, and tylenol. On repeat, her BP was 75/35 (though no longer tachycardic). She was written for 2 more liters of NS and then endorsed to medicine. Her BP improved w/ SBP in the 90s-110s with continued myalgias, headaches.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,03/10/2021,03/10/2021,0.0,OTH,"Gabapentin, hydroxyzine, meclizine, ondansetron, pantoprazole, simethicone",,"Childhood ALL with relapse in 2017 with HTLV-1 associated acute ATLL s/p DA-EPOCH and haplo-SCT c/b CMV viremia now in remission, NASH, and lap band (9/2020)",,"benadryl, demerol, reglan, phenergan, chlorpheniramine, permethrin","['Abdominal pain', 'Alanine aminotransferase normal', 'Anion gap', 'Aspartate aminotransferase normal', 'Bacterial test negative', 'Basophil count decreased', 'Basophil percentage decreased', 'Blood albumin normal', 'Blood alkaline phosphatase increased', 'Blood bilirubin normal', 'Blood calcium decreased', 'Blood chloride increased', 'Blood creatinine normal', 'Blood glucose normal', 'Blood lactic acid', 'Blood pH increased', 'Blood potassium normal', 'Blood sodium decreased', 'Blood thyroid stimulating hormone normal', 'Blood urea normal', 'Carbon dioxide normal', 'Diarrhoea', 'Dizziness', 'Eosinophil count normal', 'Eosinophil percentage', 'Haematocrit normal', 'Haemoglobin normal', 'Headache', 'Lipase normal', 'Lymphocyte count decreased', 'Lymphocyte percentage decreased', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Mean platelet volume normal', 'Monocyte count normal', 'Monocyte percentage', 'Myalgia', 'Nausea', 'Neutrophil count normal', 'Neutrophil percentage increased', 'PCO2 decreased', 'PO2 normal', 'Platelet count normal', 'Protein total normal', 'Pyrexia', 'Red blood cell count normal', 'Red blood cells urine negative', 'Red cell distribution width normal', 'Tachycardia', 'Vomiting', 'White blood cell count normal', 'White blood cells urine negative']",1,JANSSEN,IM 1092462,MO,27.0,M,"PATIENT STATES HE FELT LIGHT HEADED THEN APPEARED TO LOSE CONSCIOUSNESS AND SLUMPED OVER IN A SEATED POSITION DURING HIS 15 MINUTE OBSERVATION PERIOD. PATIENT APPEARED TO TRY TO GET UP OUT OF CHAIR AND BEGAN COVULSING, BECAME RIGID, AND COLLAPESED TO THE GROUND. PATIENT BECAME TOTALLY UNRESPONSIVE. PHARMACY STAFF ADMINISTERED EPIPEN AND WITHIN MINUTES PATIENT BECAME LETHARGIC BUT RESPONSIVE. PATIENT RECEIVED EMERGENCY CARE ON SITE FROM LOCAL PARAMEDICS AND AFTER APPROXIMATELY 15 TO 20 MINUTES WAS RESPONSIVE AND AWARE OF SURROUNDINGS. AFTER APPROXIMATELY 30 MINUTES, PATIENT FELT WELL ENOUGH TO REFUSE ADDITIONAL EMERGENCY CARE AND HAD GIRLFRIEND TAKE HIM TO THE HOSPITAL. INITIAL ONSET OF SYMPTOMS WAS APPROXIMATELY 10 MINUTES AFTER VACCINATION.",Not Reported,,Yes,Not Reported,,Not Reported,U,03/11/2021,03/11/2021,0.0,PHM,NONE NOTED,NONE NOTED,NONE NOTED,,NO KNOWN DRUG ALLERGIES,"['Dizziness', 'Lethargy', 'Loss of consciousness', 'Muscle rigidity', 'Posture abnormal', 'Seizure', 'Syncope', 'Unresponsive to stimuli']",1,MODERNA,IM 1092477,FL,83.0,F,Pericardial effusion; multiple blood clots in portal vein.,Yes,03/08/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,03/07/2021,18.0,OTH,,None,Pacemaker,,None,"['Computerised tomogram', 'Pericardial effusion', 'Portal vein thrombosis']",2,PFIZER\BIONTECH,SYR 1092483,IA,67.0,F,"Both patient and spouse we given their Moderna prime dose on 2-10-21. Both patient and spouse agreed to observe the post vaccination waiting period and reported no concerns. On 3-10-2021, they returned for their boost dose at 12:30 PM. Prior to administration of their second dose, they reported only mild headache and fatigue that presented approximately 12 hours after their first dose was administered. Once again, spouse and patient observed the post vaccination waiting period and reported no issues. On 3-11-21, I was notified that patient had passed away at home. In speaking to spouse, he stated that they both went to bed that evening with with a mild headache and fatigue. Spouse stated that he woke up early that morning with a more pronounced headache and had difficulty sleeping. He noted that at approximately 5:18 AM patient seemed to breathing heavily and may have gasped a bit. He checked on her again around 6:40 and determined that she had passed away. He contacted EMS and the technician confirmed that she had passed away. Spouse reports that the state will perform and autopsy in the next few days at the direction of Medical staff.",Yes,03/11/2021,Not Reported,Not Reported,,Not Reported,N,03/10/2021,03/11/2021,1.0,PHM,Atorvastatin 20mg daily Meloxicam 7.5mg daily Women's One- A-Day Vitamin daily Famcyclovir 250mg every 3 days Glucosamine Chondroitin 1500/1250 daily Vitamin D-3 2000 IU daily,None noted,Hyperlipidemia based on medication record,,"Combivent, gabapentin, tramadol.","['Death', 'Dyspnoea', 'Fatigue', 'Headache', 'Respiration abnormal']",2,MODERNA,IM 1092485,CA,78.0,M,"Patient felt generally unwell, tired and unable to walk well. Said his feet felt numb. He could not get up and slid to the floor. He did not have the core strength to even help him sit up. Sometime after he was assisted back on the couch around 4:30 am he must of got back up and attempted to go to restroom because he was found on the floor with his arm and face resting on the love seat which looked as if he was trying to pull himself up. His wife found him in the morning around 11:00 am and he had been died for some time according to EMS. His death was unexpected. Even when contacting his doctors they were confused as to why he had passed away. No autopsy was done but as of this moment he has not been cremated yet and is at Funeral Home.",Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,02/27/2021,02/28/2021,1.0,PVT,Parkinsons Meds maybe glipizide ktab pepcid,Parkinsons Boarderline type 2 diabetes under control,Parkinsons type two diabetes,,No known,"['Asthenia', 'Death', 'Gait inability', 'Hypoaesthesia', 'Malaise', 'Mobility decreased']",2,MODERNA,SYR 1092486,TX,61.0,F,She mentioned that ever since she got the COVID vaccine she has been experiencing constant tremors lasting 2-3 minutes. She has been feeling exhausted more than usual and cannot explain why she feels this way. Her daughter has been coming over to check on her more than usual.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/26/2021,02/26/2021,0.0,PVT,"Carbidopa-levodopa 25 mg-100 mg, Prolia 60 mg/mL, Calcium 1200 mg, Vitamin D3 10000 IU, Probiotic, Multivitamin, Estradiol 0.05 mg/24 hours ring",,"Parkinsonism, impaired fasting blood sugar, gluten-sensitive enteropathy, osteoporosis, lumbar spondylosis, psoriasis of scalp, gastric diverticulum, hallux valgus with bunions",,"Codeine, Gluten","['Fatigue', 'Tremor']",2,MODERNA,IM 1092553,MN,81.0,F,"Approximately 5 hours after vaccine, she started experiencing slight confusion. By morning she was completely confused, didn't know where she was, didn't know her daughter, was trying to take her medication by chewing them, couldn't speak, etc. BP extremely elevated. CT and labs all negative. Admitted to hospital. By the next morning she was more clear, but is still somewhat confused and still has memory loss.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,03/08/2021,03/09/2021,1.0,UNK,"Plavix, Lasix, irebesartin, cardizem, co q 10, potassium, sertraline, klonopin, pro air, advair disc, zyrtec d, fish oil,, multivitamin, vitamin c, vitamin d, copper, zinc, valerian root, several other supplements",None,"Cardiac, TIA, high blood pressure, allergies, asthma",,"Statins, gabapentin, gluten","['Abnormal behaviour', 'Amnesia', 'Aphasia', 'Blood pressure increased', 'Computerised tomogram normal', 'Confusional state', 'Disorientation', 'Laboratory test', 'Urine analysis normal']",2,PFIZER\BIONTECH,IM 1092554,AZ,90.0,M,"02/10/2021: Weakness, fatigue, headache, myalgia, bilateral bleeding from ears. 02/28/2021: Weakness that I had to use a walker to ambulate (normally ambulate independently), dizziness/vertigo, sore gums, weakness more pronounced in lower extremities below knees.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/09/2021,02/10/2021,1.0,PVT,"Montekast 10 mg PRN/q day Azelastine HCL 1% 1 spray BID PRN MacuHealth PO q day Multivitamin Vitamin D 1,000-2,000 IU q day",,Macular degeneration,,Ampicillin,"['Asthenia', 'C-reactive protein increased', 'Dizziness', 'Ear haemorrhage', 'Fatigue', 'Full blood count', 'Gingival pain', 'Headache', 'Metabolic function test', 'Muscular weakness', 'Myalgia', 'Red blood cell sedimentation rate increased', 'Vertigo', 'Walking aid user']",1,PFIZER\BIONTECH,IM 1092578,WI,78.0,F,"LTC Pharmacy was notified of a potential vaccine related hospital admission on 3/8/2021. The following information was gathered from discussion with RPH at Hospital. The patient received second dose of Pfizer COVID vaccine on 2/26/2021. The patient then had nausea, vomiting, and poor oral intake. On 2/27/2021, the patient went to the bathroom and while on the toilet, had a vasovagal event which led to her hitting the side of the face while falling. Patient was then taken to the hospital for evaluation. The patient does have a pacemaker but the cause of the event was determined to likely be due to dehydration. Lab work was performed and pertinent lab values include: potassium of 3.1, SCr of 0.8, and BUN of 13. The patient received potassium supplementation and IV hydration in the hospital. Patient was discharged on 2/28/2021. Of note, the patient does have a pacemaker and a follow-up appointment with cardiology to evaluate the pacemaker was scheduled upon discharge.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/26/2021,02/26/2021,0.0,PHM,,,Implanted Pacemaker,,,"['Blood creatinine normal', 'Blood potassium decreased', 'Blood urea normal', 'Dehydration', 'Face injury', 'Fall', 'Hypophagia', 'Nausea', 'Syncope', 'Vomiting']",UNK,PFIZER\BIONTECH,IM 1092595,TX,70.0,F,"A high risk employee received 1st vaccine dose of Moderna through the Health Center (HC) on 2/1/2021. This patient was seen as an employee only and was not established patient of the HC. The patient reported ""having symptoms of Bronchititis"" on 2/5/2021 prior to being hospitalized for 7 days (2/5/21 to 2/12/21). On 2/12/2021, an ER visit at Medical Center & transported to General Hospital on 2/13/21. On 3/11/2021, we were notified that the patient died on 3/10/21.",Yes,,Not Reported,Yes,,Not Reported,U,02/01/2021,02/05/2021,4.0,PVT,,,,,NKA,"['Bronchitis', 'Death']",1,MODERNA,IM 1092620,MO,72.0,M,"On Saturday patient began to feel fatigued. Laid down at 3 pm on 1/30/2021 and woke up Sunday morning at 730. He was feeling tired a little. Within a split second he fell back on the couch, he couldn't speak or move. He was dizzy. He was taken to the ER where he was admitted. He was noted to be in atrial fibrillation in the ambulance. His oxygen levels were below normal and temperature was elevated. He was admitted to the hospital for two weeks and was released in February.",Not Reported,,Not Reported,Yes,16.0,Not Reported,Y,01/28/2021,01/30/2021,2.0,PUB,,Patient was Covid positive at the time of vaccination but unaware,none,,NKA,"['Aphasia', 'Atrial fibrillation', 'Body temperature increased', 'Dizziness', 'Fall', 'Fatigue', 'Mobility decreased', 'Movement disorder', 'Oxygen saturation decreased']",1,PFIZER\BIONTECH,IM 1092628,NC,26.0,F,"Pt. has a history of dizziness/nausea after vaccination. 15 minutes after this vaccination, she had a short 'seizure-like' episode accompanied with slight shortness of breath. Pt. was also very dizzy and nauseous. Sweating came shortly after. EMS was called immediately when first symptoms began. She was responsive the entire time and reported gradually feeling better after about 5-10 minutes. EMS did a prompt check-up and revealed no unusual findings.",Not Reported,,Not Reported,Yes,,Not Reported,U,03/11/2021,03/11/2021,0.0,PHM,,,asthma,,"tree nuts, zantac","['Dizziness', 'Dyspnoea', 'Hyperhidrosis', 'Nausea', 'Seizure like phenomena']",1,PFIZER\BIONTECH,IM 1092649,WI,94.0,F,"Red pruritic rash at the injection site Two days following vaccination, she had an episode of syncope with fall, head trauma, rhabdomyolysis that resulted in hospitalization",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/23/2021,02/25/2021,2.0,PVT,,,"cognitive impairment, hypertension, dyslipidemia, T2DM, esophageal reflux, depression, polymyalgia rheumatica, osteopenia, osteoarthritis, and breast cancer S/P lumpectomy in 2005.",Suspected cellulitis; now thought to be rash at injection site after 1st Moderna vaccine,None,"['Fall', 'Head injury', 'Injection site erythema', 'Injection site pruritus', 'Injection site rash', 'Rhabdomyolysis', 'Syncope']",2,MODERNA,SYR 1092651,CA,77.0,M,DEATH,Yes,02/27/2021,Not Reported,Not Reported,,Not Reported,N,02/26/2021,02/27/2021,1.0,PHM,"HTN, DM, Cholesterol and blood thinners",+Covid in January 2021,Cardiac,,None,['Death'],1,MODERNA,IM 1092653,CA,88.0,F,"Patient received the vaccine on the evening of 03-09-2021. R.N. states she was ""fine "" at 440 AM bed check. At 0830 03-10-2021 patient was found slumped over on her bathroom toilet having expired sometime between 440AM and 830 AM",Yes,03/10/2021,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/10/2021,1.0,SEN,"Vitamin B12,C,D3. Eyedrops, probiotics","Bladder cancer, Malignant melanoma, both in remission","Interstitial cystitis, mitral valve prolapse, aortic calcifications consistent with asymptomatic atherosclerotic vascular disease.",,robitussin,['Death'],2,MODERNA,SYR 1092664,CA,67.0,M,"Patient reports that he noticed chest pain after getting his COVID19 shot on 3/7/2021. While patient admits that his arm felt sore, he reports that he was surprised to find mid chest pressure developing and persisting long after the shoulder pain resolved. Patient describes the pain as a pressure-like sensation mid chest with some radiation to the shoulder, overall fairly mild in intensity (3/10). Patient states that the pain seems to be brought on by ""every day activities"" Patient reports that he walks but does not engage in strenuous activity typically. Patient denies experiencing acid reflux. Patient reports that the pain was resolved by nitroglycerin.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,03/07/2021,03/07/2021,0.0,OTH,"Atenolol 25mg, ASA 81mg, Atorvastatin 40mg, Tamsulosin 0.4mg, Sildenafil as needed",,"HTN, HLD, CAD (Hx MI 2010, s/p PCI to LAD), atherosclerosis of the aorta, and prostate cancer (s/p brachytherapy 2017)",,"keflex, penicillin","['Arthralgia', 'Chest discomfort', 'Chest pain', 'Loss of personal independence in daily activities', 'Pain in extremity']",2,PFIZER\BIONTECH,SC 1092682,NC,37.0,F,"Aprox 3 min after injection, broke out in rash and hives, severe itching in neck, face, chest, tingling lips and shaking. EMS was on scene at clinic immediately removed me from car and checked vitals, BP was high 176/94, took by ambulance to ER at Medical Center. Treated in ER for 4.5 hours. Developed migraine, received benadryl, steriods,and medicine for the migraine. Sent home told take benadryl for 2 days and do",Not Reported,,Yes,Not Reported,,Not Reported,U,03/11/2021,03/11/2021,0.0,PUB,"Prozac, oxycodone, vistaril, doxepin",Torticollis,"Spinal cord stimulatorn installed nov 17. Several back surgeries, depression and anxiety",,"Highly allergic to bees, lactose intolerance","['Blood pressure increased', 'Migraine', 'Paraesthesia oral', 'Pruritus', 'Rash', 'Tremor', 'Urticaria']",1,PFIZER\BIONTECH,SYR 1092684,CO,41.0,F,"Fever reaching 102.5, chills, muscle aches 9 hours following vaccination Acute appendicitis - approximately 20 hours following vaccination",Not Reported,,Yes,Yes,1.0,Not Reported,Y,03/06/2021,03/07/2021,1.0,PVT,None.,None.,None.,,None.,"['Appendicitis', 'Chills', 'Computerised tomogram', 'Full blood count', 'Myalgia', 'Pyrexia']",,JANSSEN,IM 1092685,NY,68.0,F,"Symptoms started at 5:15 PM the next day, about 20 hours after vaccination - Vomiting - High heart rate - Suspected seizure (symptoms differed from the past instances) - Loss of coherence (intermittent for 2 hours) Ambulance brought her to hospital, where she was in ER and later admitted. She is still at hospital under observation at this time, with no discharge date set.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,03/09/2021,03/10/2021,1.0,PUB,Keppra (leviteracetam) Divalproex Co-Q 10 Low-dose (81 mg) aspirin,No short-term illness,History of seizures (epileptic),,None,"['Electrocardiogram', 'Electroencephalogram', 'Heart rate increased', 'Incoherent', 'Magnetic resonance imaging', 'Seizure', 'Vomiting']",2,MODERNA,SYR 1092700,CA,70.0,M,"Received COVID vaccine 1/26/21 and 2/12/21, and didn't have symptoms right after vaccine. Symptoms started Wednesday February 2/24/21 - started at 9PM that night preventing him from sleeping. Stated the chest pressure was like something ""sitting on his chest"". Also had body aches, chills, fever, fatigue, cough, and mild shortness of breath. Found to have heart failure, EF 25%",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,02/12/2021,02/24/2021,12.0,SCH,"Crestor 20mg, Protonix 40mg prn",,"hyperlipidemia, prediabetes (HGBA1C 6.1 02/22/2020), 15 pack year smoking history and GERD",,none,"['Angiogram abnormal', 'Cardiac failure', 'Chest discomfort', 'Chills', 'Coronary artery disease', 'Cough', 'Dyspnoea', 'Echocardiogram abnormal', 'Ejection fraction decreased', 'Fatigue', 'Pain', 'Pyrexia', 'Sleep disorder']",2,PFIZER\BIONTECH,IM 1092722,OH,91.0,F,"STROKE SYMPTOMS, DIFFICULTY AMBULATING, IMPAIRED SPEECH",Not Reported,,Not Reported,Yes,5.0,Yes,N,,,,OTH,"NORVASC, HYDROCHLOROTHIAZIDE",HYPERTENSION,HYPERTENSION,,NONE,"['Gait disturbance', 'Neurological symptom', 'Speech disorder']",UNK,PFIZER\BIONTECH, 1092737,ME,69.0,M,"Sudden death. Alone at home, found on floor 4 hours after last phone contact",Yes,03/11/2021,Not Reported,Not Reported,,Not Reported,N,02/27/2021,03/11/2021,12.0,PHM,Levothyroxine Insulin Diabetes meds,,"Diabetes, coronary artery disease, hypothyroidism",,None known,['Sudden death'],1,MODERNA,UN 1092810,MN,34.0,F,"Seizures starting 1/25/21, transverse myelitis diagnosed 3/1/21 with symptoms of transverse myelitis starting 2/5/21. Now with diagnosis of multiple sclerosis but with atypical initial presentation",Not Reported,,Not Reported,Yes,10.0,Not Reported,N,01/06/2021,01/25/2021,19.0,PVT,Bupropion,No known illness,"Anxiety, environmental allergies",,None,"['Blood test', 'Lumbar puncture', 'Magnetic resonance imaging', 'Multiple sclerosis', 'Myelitis transverse', 'Seizure']",1,PFIZER\BIONTECH,IM 1092857,FL,76.0,M,"Patient was admitted to the Neuro ICU in critical condition. He is there currently on 4 seizure medications AND INTUBATED WITH GENERAL ANESTHESIA TO CONTROL THE SEIZURES. All diagnostic tests including MRI's, CT scans, laboratory tests, Spinal taps are negative. He was presented and they can arrive at no diagnosis!!!!! He has no history of a seizure disorder.",Not Reported,,Yes,Yes,11.0,Not Reported,N,02/10/2021,03/01/2021,19.0,PVT,Levetiracetam; Atorvastatin; -zolpidem; levothyroxine; pepcid; folbic; losartan-HCTZ. Zyrtec,Coronary artery disease. Prediabetic. Hypertension. Deaf in 1 ear.,"CAD; prediabetic, hypertension, hypothyroid",,Penicillin,"['Blood test', 'Computerised tomogram normal', 'Endotracheal intubation', 'Intensive care', 'Laboratory test normal', 'Lumbar puncture normal', 'Magnetic resonance imaging normal', 'Seizure']",2,PFIZER\BIONTECH,IM 1092883,ME,72.0,M,"Death. Patient lived alone, was found dead at 11:04 the morning following his second dose of vaccine. Actual time of death is unknown. Time of vaccine administration the previous day is estimated.",Yes,03/10/2021,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/10/2021,1.0,PVT,"Aspirin, telmisartan, valacyclovir, brinzolamide/brimonidine, fluoromethalone, lumigan, timolol",Vertigo,"Coronary artery disease, hypertension, hyperlipidemia",,"Lyrica, Prinivil, Lipitor, Penicillin",['Death'],2,PFIZER\BIONTECH,IM 1092904,UT,69.0,F,"Developed tachycardia and shortness of breath on 3/1/21 which was significantly worse on 3/2/2021. Went to ER and CT angio showed diffuse bilateral pulmonary embolism. Spent the night for heparin, telemetry monitoring and lab work.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,02/01/2021,03/01/2021,28.0,PUB,"Zoloft, Trazadone, Cytomel, Synthroid, Vitamin D3",None,"Obesity, hypothyroidism, insomnia",,"Tetracycline, Septra DS","['Angiogram pulmonary abnormal', 'Chest X-ray', 'Computerised tomogram thorax', 'Dyspnoea', 'Echocardiogram', 'Electrocardiogram', 'Laboratory test', 'Pulmonary embolism', 'Tachycardia', 'Troponin increased']",2,MODERNA,IM 1092933,WA,57.0,F,"Fever 99.9 degrees, throwing up, nausea, disorientation, loss of appetite, body aches, headache, loss of speech, loss of writing, loss of understanding. admitted to ER hospital the Wednesday 2/17 @ 3:30pm. Sodium level dropped to 123 and dehydrated. Given IV and stayed overnight",Not Reported,,Yes,Yes,1.0,Not Reported,Y,02/16/2021,02/17/2021,1.0,PVT,Lisiniprol 20 mg - hydrochoro 12.5 tablet,none,"pre diabetes, high blood pressure",,"ceclor, ceftin, amoxicillan, sulfa","['Aphasia', 'Blood sodium decreased', 'Blood test', 'Decreased appetite', 'Dehydration', 'Disorientation', 'Dysgraphia', 'Headache', 'Influenza like illness', 'Nausea', 'Pain', 'Pyrexia', 'Scan', 'Vomiting']",2,MODERNA,IM 1092957,UT,71.0,M,"Received 2nd dose of Pfizer COVID vaccine on 2/24/21. No reported adverse reaction at that time. On 3/10/21, developed worsening of chronic back pain. On day of event, took a dose of celecoxib and rivaroxaban (concurrently). He had been avoiding taken chronic celecoxib since at least the time of his last COVID-19 vaccination, and potentially took this fairly rarely due to concern for interaction with his DOAC. Beginning about 5 minutes after these medicaions were taken, patient felt weak/strange and asked his wife to take him to ED. In ED he was initially somnolent but arousable, but then developed hypotension and hypoxemia. Given IV benadryl initially, but then acutely worsened with development of facial, hand, and neck swelling. Reportedly had substantial ""frothing at the mouth."" Treated with SQ epinephrine, IV methylprednisolone, IV famotidine and was intubated with difficulty. Started on an epinephrine infusion due to persistent hypotension (dose up to 0.1 mcg/kg/min) and transferred to referral center ICU (reporting center). On arrival here, notable hand edema, some facial edema. Ventilator support rapidly weaned to minimal settings. Evaluation and hospitalization ongoing. Overall clinical assessment is anaphylactic reaction to celecoxib unrelated to COVID-19 vaccination.",Not Reported,,Yes,Yes,,Not Reported,N,02/24/2021,03/11/2021,15.0,UNK,"amLODIPine 2.5 mg oral tablet, 2.5 mg= 1 tabs, Oral, Daily aspirin 81 mg oral delayed release tablet, 81 mg= 1 tabs, Oral, Daily carvedilol 12.5 mg oral tablet, 12.5 mg= 1 tabs, Oral, BID, 3 refills CeleBREX 200 mg oral capsule, 200 mg= 1 c",None known,Allergic rhinitis Coronary artery disease Back pain Hypertension Insomnia Neuropathy Paroxysmal atrial fibrillation,,ACE inhibitor (cough),"['Anaphylactic reaction', 'Angiogram pulmonary abnormal', 'Aspartate aminotransferase increased', 'Asthenia', 'Atelectasis', 'Back pain', 'Blood lactic acid increased', 'Computerised tomogram head normal', 'Endotracheal intubation complication', 'Eosinophil percentage increased', 'Face oedema', 'Feeling abnormal', 'Foaming at mouth', 'Full blood count', 'Hypotension', 'Hypoxia', 'Intensive care', 'Lung consolidation', 'Mechanical ventilation', 'Metabolic function test', 'Oedema peripheral', 'Peripheral swelling', 'Somnolence', 'Swelling', 'Swelling face', 'White blood cell count normal']",2,PFIZER\BIONTECH,IM 1092967,AZ,69.0,F,Patient had MRI on 3/3/21 and a lung nodule and breast nodule was found on her right side which was the side she received the vaccine on. They do not know if malignant or not at this time. She has a follow up on 3/15/21 for a chest CT scan and will get a biopsy done soon.,Not Reported,,Not Reported,Not Reported,,Yes,U,02/11/2021,03/03/2021,20.0,PHM,Unknown,"Possible breast cancer-type, stage unknown",Unknown,,None,"['Breast mass', 'Magnetic resonance imaging', 'Pulmonary mass']",1,MODERNA,IM 1093043,PA,64.0,M,"The second shot was on February 19. On February 20 and 21, patient experienced a sore arm and flu-like symptoms. On Febuary 28, he had a stroke. Hospital where the ambulance took him initially diagnosed it as Bells Palsy and prescribed prednisone and an anti-viral. After an MRI the next day on Monday, he was diagnosed correctly as a stroke. On Tuesday, he was airlifted to another hospital and was in the ICU for more than 2 days. Patient spent the next 7 days in the neuro-trauma step-down unit with the results of the debilitating stroke. He is unable to swallow and his entire left side is affected as well as vision and hearing.",Not Reported,,Yes,Yes,11.0,Yes,N,02/19/2021,02/20/2021,1.0,OTH,None,None,None,,None,"[""Bell's palsy"", 'Cerebrovascular accident', 'Dysphagia', 'Hemiparesis', 'Hypoacusis', 'Influenza like illness', 'Intensive care', 'Magnetic resonance imaging head abnormal', 'Pain in extremity', 'SARS-CoV-2 test negative', 'Visual impairment']",2,MODERNA,SYR 1093361,CA,45.0,M,Acute right index finger digital ischemia after initial complete numbness from PIP joint distally absent any previous symptoms ever. Recurrence Jan 20 of same symptoms. Suspect antibody complex clot blocking terminal branches of digital arteries.,Not Reported,,Not Reported,Not Reported,,Yes,N,01/12/2021,01/13/2021,1.0,OTH,HIPAA,None,None,,None,"['Hypoaesthesia', 'Peripheral ischaemia', 'Thrombosis']",2,PFIZER\BIONTECH,IM 1093317,VA,25.0,F,"Feelt very tired; loss of consciousness with fainting; Felt like her throat was closing; Chills; A spontaneous report was received from a consumer concerning a 25-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of consciousness, felt like her throat was closing, chills and felt very tired The patient's medical history was not provided. No relevant concomitant medications were reported. Laboratory data was Prolong QT interval on ECG reported. On 20 Jan 2021, approximately same day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 20 Jan 2021, 5 minutes after vaccination, the patient felt like her throat was closing, chills, lightheaded and fainted. In the ER the work up for syncope revealed prolonged qt interval on ECG. Treatment included Benadryl, Magnesium, fluids. The patient was discharged on the same day but she still feels tired having brain fog. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events were not reported; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/20/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Chills', 'Electrocardiogram', 'Fatigue', 'Syncope', 'Throat tightness']",1,MODERNA,OT 1093318,FL,65.0,F,"Cellulitis; Dermatitis; A reddish rash at the same spot of the vaccine; A reddish rash at the same spot of the vaccine; Itchy at the same spot of the vaccine; A lot of pain in the arm; A spontaneous report was received from a consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a lot of pain in the arm, itchy at the same spot of the vaccine, a reddish rash at the same spot of the vaccine, dermatitis and cellulitis. The patient's medical history was not provided. Concomitant medications reported were Hydrochlorothiazide, Pepcid (Famotidine) drug used for unknown indication. On 13-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13-Jan-2021, the patient experienced a lot of pain in the arm . On 21-Jan-2021, the patient experienced itchy at the same spot of the vaccine . On an unknown date, the patient experienced the events a reddish rash at the same spot of the vaccine, dermatitis and cellulitis. The patient received antibiotics and prednisone for dermatitis and cellulitis. No treatment information was other events. Action taken with mRNA-1273 in response to the events were not reported. On 18-Jan-2021 the outcome for a lot of pain in the arm was resolved. The outcome of other events were recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/13/2021,01/13/2021,0.0,UNK,HYDROCHLOROTHIAZIDE; FAMOTIDINE,,Medical History/Concurrent Conditions: No adverse event (No reported adverse event),,,"['Cellulitis', 'Dermatitis', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site pruritus', 'Vaccination site rash']",1,MODERNA,OT 1093319,IL,,F,"Entire dose ran down her arm/didn't get the full dose; Entire dose ran down her arm/didn't get the full dose; A spontaneous report was received from a 61-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and entire dose ran down her arm/didn't get the full dose. (PT: Product administration error) (PT: Underdose) The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 011M20A/ 011W20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Feb 2021, the patient reported she did not receive the entire dose of vaccine as it ran down her arm . No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The event entire dose ran down her arm/didn't get the full dose. (PT: Product administration error) (PT: Underdose), was considered resolved. The reporter did not provide an assessment for the event entire dose ran down her arm/didn't get the full dose. (PT: Product administration error) (PT: Underdose); Reporter's Comments: This report refers to a case of Product administration error and. underdose for mRNA-1273 (lot # 011M20A/ 011W20A) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Product administration error', 'Underdose']",2,MODERNA,OT 1093320,NC,17.0,M,"17 year old recevied vaccine; A spontaneous report as received from a pharmacist concerning a 17-year-old, male patient, who received Moderna COVID-19 vaccine and considered as product administered to patient of inappropriate age . The patient's had no known past medical history of drug addiction or an adverse reactions to vaccines. Concomitant medications were not provided. On 22 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number:010M20A) through intramuscular route in the right deltoid for prophylaxis of COVID-19 infection. No treatment information was provided. Lab details were not provided. Action taken with mRNA-1273 in response to the event was not applicable The outcome of inappropriate age at vaccination administration was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273. There were no reported adverse events associated with this case.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Product administered to patient of inappropriate age'],UNK,MODERNA,OT 1093321,,,F,"90% blockage of her heart; shortness of breath; tired when she walks; A spontaneous report was received on 2 Feb 2021, from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 90% blockage of her heart, tired when she walks, and shortness of breath. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. The patient is scheduled for second dose. On an unknown date, the patient experienced events, 90% blockage of her heart, tired when she walks, and shortness of breath. Treatment details not provided. Action taken with mRNA-1273 in response to the events was not reported. On an unknown date the outcome of events include 90% blockage of her heart, tired when she walks, and shortness of breath were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Coronary artery stenosis', 'Dyspnoea', 'Fatigue']",1,MODERNA,OT 1093322,OH,,M,"congestive heart failure; inadvertently administered another dose (3rd dose); tested positive for Covid-19; A spontaneous report was received from a nurse and other health care professional for a 91-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced congestive heart failure, tested positive for Covid-19 and inadvertently administered another dose (3rd dose). The patient's medical history was not provided. No concomitant product use was reported. On 22-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 23-JAN-2021, 1day after receiving the vaccine the patient was hospitalized due to congestive heart failure. The patient had difficulty of breathing at that time. On 03-FEB-2021, the patient tested positive for covid-19. The patient was transferred to a rehabilitation facility on an unspecified date to recuperate. On 25-FEB-2021 at around 11:30 in the morning, the patient was given second dose of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of covid-19 infection at a rehabilitation facility. On the same day at around 02:30 PM, a group of vaccine providers came and inadvertently administered another dose (third dose) of the vaccine mRNA-1273 (lot number: not provided) to the patient. Apparently, there was two patients with the same names, and they did not check the birthdays. The health care professional reported that at the time of this report, the patient was in the hospital and was on a ventilator. Treatment information included ventilation. Action taken with mRNA-1273 was not applicable. The outcome of the events, congestive heart failure and tested positive for Covid-19 was unknown and the outcome for the event inadvertently administered another dose (3rd dose) was recovered/resolved. The reporter did not provide the assessment for the event's congestive heart failure, tested positive for Covid-19 and inadvertently administered another dose (3rd dose).; Reporter's Comments: COVID-19 in this patient is unlikely to be related to Moderna COVID-19 vaccine. Based on the current available information and temporal association, a causal relation between the product and congestive heart failure cannot be excluded. Medication error of extra dose administered for (mRNA-1273), lot # unknown was reported, with no associated AEs reported after the additional dose.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/22/2021,01/23/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['COVID-19', 'Cardiac failure congestive', 'Extra dose administered']",3,MODERNA,OT 1093323,NY,,F,"Lightheaded; passed out; Lymph knot under armpit; A spontaneous report was received from a consumer for a 67-year-old female patient who experienced light headedness and passed out. She also had lymph knots under her armpit. The patient's medical history was not reported. No concomitant product use was reported. On 26 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Feb 2021, next day after receiving the vaccine, the patient felt lightheaded and passed out and was hospitalized. She also experienced lymph knots under her armpit. Action taken with mRNA-1273 with respect to the events was not reported. The outcome of the events was not reported. The reporter did not provide the causality assessment for the events.; Reporter's Comments: Based on the current available information which shows a strong temporal association between the use of the product and the start date of the reported event, a causal relationship with the event cannot be excluded. Axillary lymphadenopathy is consistent with the known safety profile of the mRNA-1273",Not Reported,,Not Reported,Yes,,Not Reported,U,02/26/2021,02/27/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Dizziness', 'Loss of consciousness', 'Lymphadenopathy']",1,MODERNA,OT 1093324,,65.0,F,"bladder felt full, like they could not empty it; limited bowel function; vomiting that day; limited appetite; dry mouth; felt very dizzy; extreme tiredness for 3 weeks; A spontaneous report was received from a healthcare professional concerning a 65-year-old, female patient, who experienced urinary retention, dizziness, vomiting, fatigue, decreased appetite, dry mouth and limited bowel function. The patient's medical history, as provided by the reporter, included two time cancer survivor . Concomitant medications reported included Carvedilol for high blood pressure, acetamide for cholesterol, potassium, multivitamins, zinc, calcium, Vitamin D. On 05 Feb, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) in the left arm for prophylaxis of COVID-19 infection. Patient was ok at midnight, but when they woke up, they felt very dizzy, were vomiting that day, and experienced extreme tiredness for 3 weeks, now they feel relatively recovered, like 90%, but still somewhat tired, probably related to not been able to eat on account of having very limited appetite. They mentioned they had limited bowel function, and their bladder felt full, like they could not empty it. Patient states they had a dry mouth from the beginning of the symptoms. After a week of these symptoms, on Saturday, the patient went to a clinic and they did some bloodwork and found that the liver enzymes were elevated and 5 more values were not normal and that their kidney function was not normal. They consulted with their oncologist and they believed these could be an extreme immune response to the vaccine, since the lab work conducted on the 23Dec2020 was normal. Last Friday they have some blood tests and the values were back to normal. Treatment for the events included paracetamol and ibuprofen alternating; and Prednisone. Action taken with mRNA-1273 in response to the events was not reported. The events, dizziness, vomiting, fatigue, dry mouth were relatively recovered, like 90%, but still somewhat tired. The outcome events, urinary retention, decreased appetite, and limited bowel function are unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,UNK,CARVEDILOL; ACETAMIDE; POTASSIUM; MULTIVITAMINS [VITAMINS NOS]; ZINC; CALCIUM; VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: Cancer (Patient mentions they are a two time cancer survivor),,,"['Decreased appetite', 'Dizziness', 'Dry mouth', 'Fatigue', 'Functional gastrointestinal disorder', 'Liver function test', 'Renal impairment', 'Urinary retention', 'Vomiting']",1,MODERNA, 1093325,MN,,F,"Cellulitis; Hot at the injection site; Itchiness at the injection site; Redness at the injection site; Pain at the injection site; A spontaneous report was received from a 67 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed cellulitis, redness at the injection site, itchiness at the injection site, hot at the injection site, and pain at the injection site. The patient's medical history and concomitant medications were not provided. On 18-FEB-2021, 8 days prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (batch number: 010M20A) intramuscularly in the left arm for the prophylaxis of COVID-19 infection. On 26-FEB-2021, the patient developed cellulitis, redness at the injection site, itchiness at the injection site, hot at the injection site, and pain at the injection site. Treatment included administration of antibiotics. Action taken with mRNA-1273 in response to the events was not reported. The outcomes of the events, cellulitis, redness at the injection site, itchiness at the injection site, hot at the injection site, and pain at the injection site, were reported as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,02/26/2021,8.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Cellulitis', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site pruritus', 'Vaccination site warmth']",1,MODERNA,OT 1093326,VT,70.0,F,"reveled mild pneumonia; I tested positive for Covid19 19Feb (3 weeks +2days) after 2nd dose of vaccine; I tested positive for Covid19 19Feb (3 weeks +2days) after 2nd dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262; expiry date: unknown) via an unspecified route of administration in the left arm, on 28Jan2021 at 15:00, at a single dose, for COVID-19 immunisation. Medical history included known allergies to penicillins. Concomitant medication included acyclovir (ACICLOVIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284) in the left arm, on 06Jan2021 at 13:00, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID-19 vaccination. The patient had dry cough and difficulty getting deep satisfying breath about 12Feb2021 (2 weeks + 2 days) after 2nd dose of Pfizer vaccine. The patient tested positive for COVID-19 nasal swab on 19Feb2021 (3 weeks +2days) after 2nd dose of vaccine. On 24Feb2021, patient was seen in a physician office for symptoms of cough and shortness of breath (SOB). On the same day (24Feb2021), chest X-ray revealed mild pneumonia. Patient was now on prednisone, azithromycin and albuterol inhaler. Patient was a little better and was now on 3rd day of taking 3 medications. Outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/19/2021,22.0,UNK,ACYCLOVIR [ACICLOVIR],,Medical History/Concurrent Conditions: Penicillin allergy,,,"['COVID-19', 'Chest X-ray', 'Pneumonia', 'SARS-CoV-2 test', 'Vaccination failure']",2,PFIZER\BIONTECH, 1093327,GA,34.0,F,"dizzy; blood pressure, it was ""high"", around 129/88; shortness of breath; urge to vomit (nausea); faint; body aches; headache; her arm hurt; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 11Feb2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Pfizer's vaccine on Thursday, morning (11Feb2021), at the time her arm hurt. She had body aches the entire Friday (12Feb2021) and headache; she stayed in bed all day and the next day, she took Tylenol. On Saturday (13Feb2021), she had shortness of breath and the urge to vomit (nausea), she was about to faint. She was also dizzy and checked her blood pressure, it was ""high"", around 129/88, but she can't recall the values exactly. She doesn't know if she should get the second dose because she's scared. The patient wanted to know if these are symptoms from the vaccine or could it have been a reaction or allergy. She is scheduled for the second dose on 04Mar2021. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/11/2021,0.0,UNK,,,,,,"['Blood pressure measurement', 'Dizziness', 'Dyspnoea', 'Headache', 'Hypertension', 'Nausea', 'Pain', 'Pain in extremity', 'Syncope']",1,PFIZER\BIONTECH, 1093328,CA,82.0,M,"Pemphigus; blisters over upper body; This is a spontaneous report from a contactable physician. An 82-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration on left arm on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included glaucoma, AMD and arrhythmia. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), rosuvastatin calcium (CRESTOR) and timolol. The patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: lot number: EL 1284 on left arm) on 30Dec2020 for covid-19 immunisation and experienced hives in the back. The patient experienced pemphigus and blisters over upper body on 18Feb2021 12:00. The patient underwent lab tests and procedures which included Skin Bx: confirm pemphigus on an unspecified date. Therapeutic measures were taken as a result of pemphigus and blisters included prednisone. Outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events ""Pemphigus and blisters over upper body"" cannot be completely excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,02/18/2021,29.0,PVT,BYSTOLIC; CRESTOR; TIMOLOL,,Medical History/Concurrent Conditions: Age-related macular degeneration; Arrhythmia; Glaucoma,,,"['Biopsy skin', 'Blister', 'Pemphigus']",2,PFIZER\BIONTECH, 1093329,PA,,F,"spinal cord modulation pain; This is a spontaneous report via a Pfizer-sponsored program, from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer said she received the 1st dose of the Pfizer-BioNTech Covid19 Vaccine on Wednesday. She said that she has not had any pain related to the vaccine. However, she has the condition, spinal cord modulation pain (unspecified date in Feb2021). She said she was prescribed to take hydrocodone/paracetamol (VICODIN) once every other night. She wants to know if this is okay and wants to know how long she has to wait to take the medication after receiving her 2nd dose. She is asking if she can already take the medicine VICODIN before the 2nd dose or she can take the medicine after she got the 2nd dose instead. The outcome of the event was unknown. Information on lot number/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,,,,,['Spinal cord disorder'],1,PFIZER\BIONTECH, 1093330,,,F,"blood pressure was high 210/106; facial tongue tingling; facial tongue tingling; numb; metallic taste in mouth; This is a spontaneous report from a contactable nurse. A 75-year-old female patient received her first dose of BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date were not reported), via an unspecified route of administration on 25Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After getting her first dose on unspecified date in Feb2021, the patient experienced facial tongue tingling and numb, blood pressure was high 210/106 and had a metallic taste in mouth. Paramedics gave her Benadryl and monitored for an hour. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Due to a positive drug-event temporal association and lacking identified alternative explanations, the company, despite no patient's medical history, concomitant medication and baseline and follow-up values of blood pressure have been provided, cannot completely exclude that the reported high value of blood pressure is related to BNT162b2 administration. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/25/2021,02/01/2021,,UNK,,,,,,"['Blood pressure measurement', 'Dysgeusia', 'Hypertension', 'Hypoaesthesia', 'Paraesthesia', 'Paraesthesia oral']",1,PFIZER\BIONTECH, 1093331,TX,37.0,M,"Acute pericarditis; This is a spontaneous report from a contactable Physician reporting for himself A 37-year-old Male Physician received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EZ3248) on 11Jan2020 at single dose, via an unspecified route of administration, on left arm for COVID-19 immunization. Relevant medical history included hypothyroidism and hyperlipidemia. The patient received first dose of BNT162B2 on Dec2020 via an unspecified route of administration on left arm for COVID-19 immunization. Concomitant medications included atorvastatin and levothyroxine sodium (SYNTHROID). On 21Feb2021 at 17:00, the patient experienced acute pericarditis resulted in doctor office/clinic visit. Treatment received included Ibuprofen, Colchicine and Pantoprazole. At the time of the reporting, the patient was recovering from the event.; Sender's Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported event cannot be excluded, due to a plausible temporal relationship. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/11/2021,02/21/2021,41.0,PVT,ATORVASTATIN; SYNTHROID,,Medical History/Concurrent Conditions: Hyperlipidemia; Hypothyroidism,,,"['Pericarditis', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1093332,CA,44.0,F,"dizziness on the verge of passing out; welts all over midsection from upper legs through hips and onto torso lasting for weeks; Intense headache; dizziness on the verge of passing out; flushed face and ears; This is a spontaneous report from a non-contactable other healthcare professional. This 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1283), dose 1, single dose via an intramuscular route of administration in the left arm on 10Feb2021 at 10:30 AM (at the age of 44- years-old) for COVID-19 vaccination. Medical history included complete thyroidectomy with neck dissection (removed lymph) for papillary thyroid cancer with neck dissection (removed lymph) for papillary thyroid cancer- otherwise healthy and penicillin allergy. The patient was tested for COVID-19 on 14Aug2020 by nasal swab and was negative. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 at 10:30 AM, the patient experienced intense headache within 5 minutes, dizziness on the verge of passing out (waited in the lobby for 1 hour before leaving), flushed face and ears, headache for several days, welts all over midsection from upper legs through hips and onto torso lasting for weeks. The clinical outcome of headache, dizziness on the verge of passing out, flushed face and ears, headache and welts was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,02/10/2021,0.0,UNK,SYNTHROID,,Medical History/Concurrent Conditions: Papillary thyroid cancer; Penicillin allergy (Known allergies: penicillin); SARS-CoV-2 test (COVID test Nasal Swab: negative); Thyroidectomy total (with neck dissection (removed lymph) for papillary thyroid cancer- otherwise healthy),,,"['Dizziness', 'Flushing', 'Headache', 'Loss of consciousness', 'Urticaria']",1,PFIZER\BIONTECH,OT 1093333,FL,,F,"I fell and must have passed out; I fell and must have passed out; painful, large red swollen arm at injection site (size of half a baseball in height and about 6 inches down my arm); painful, large red swollen arm at injection site (size of half a baseball in height and about 6 inches down my arm); Body pain; severe headache; fever (100/sweating); chills (shaking with temp drop- 97.2; normal 97.6); vomiting; loose stools; Lost 6 lbs; abrasion on her right side forehead; dizzy; weak; fever (100/sweating); nausea; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation, at 68 years old. Medical history included Metastatic breast cancer, thyroid, glaucoma, osteo arthritis, neuropathy, sulfa allergy, Fish/shellfish allergy, penicillin allergy, MS (Multiple sclerosis), and Phenothiazines allergy. No other vaccines in four weeks were received. The patient is not pregnant at the time of vaccination. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included amlodipine, levothyroxine sodium (SYNTHROID), gabapentin, timolol, and cyanocobalamin (B12), therapy dates and indications unspecified, in two weeks. The patient previously took Cytoxan, cipro, Demerol and experienced allergies. On 28Jan2021 20:00 (also reported as about 8 hours), the patient experienced body pain; severe headache; fever (100/sweating); chills (shaking with temp drop- 97.2; normal 97.6); Nausea; vomiting; loose stools; painful, large red swollen arm at injection site (investigation: size of half a baseball in height and about 6 inches down her arm); dizzy; weak; and she fell and must have passed out. Woke up on floor with abrasion on her right-side forehead. The patient also reported she lost 6 lbs. The events lasted from Thursday evening to Sunday morning. Treatment for the adverse events included BENARDRYL. Outcome of the events was recovered on 29Jan2021. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9267) via an unspecified route of administration (right arm) on 18Feb2021 09:30 for COVID-19 immunisation. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,01/28/2021,,PUB,AMLODIPINE; SYNTHROID; GABAPENTIN; TIMOLOL; B12 [CYANOCOBALAMIN],,Medical History/Concurrent Conditions: Drug allergy; Fish allergy; Glaucoma; Metastatic breast cancer; MS; Neuropathy; Osteoarthritis; Penicillin allergy; Sulfonamide allergy; Thyroid disorder,,,"['Asthenia', 'Body temperature', 'Chills', 'Diarrhoea', 'Dizziness', 'Fall', 'Headache', 'Hyperhidrosis', 'Investigation', 'Loss of consciousness', 'Nausea', 'Pain', 'Pyrexia', 'Skin abrasion', 'Vaccination site pain', 'Vaccination site swelling', 'Vomiting', 'Weight', 'Weight decreased']",1,PFIZER\BIONTECH, 1093334,NJ,71.0,F,"led to a fall (possible faint) that caused a head injury (bone chip above her eye).; led to a fall (possible faint) that caused a head injury (bone chip above her eye); led to a fall (possible faint) that caused a head injury (bone chip above her eye); led to a fall (possible faint) that caused a head injury (bone chip above her eye); Nausea; shivers; fever; dehydration; This is a spontaneous report from a non-contactable consumer (patient) 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (batch/lot number and expiry date not reported) via an unspecified route of administration, on 22Feb2021 (in the age of 71-years-old) at single dose for covid-19 immunization. Medical history included chronic headaches, high cholesterol, high blood pressure and minor heart condition. Patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included candesartan, rosuvastatin, gabapentin, topiramate, amitriptyline and erenumab aooe (AIMOVIG), all from an unspecified date for an unspecified indication. It was reported that 2 days after second dose (reported as 24Feb2021), the patient experienced nausea, shivers, fever and dehydration which led to a fall (possible faint) that caused a head injury (bone chip above her eye). As a result, the patient had an ER visit and they provided her with fluids and stitches. The outcome of events was reported as 'recovering'. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/24/2021,2.0,UNK,CANDESARTAN; ROSUVASTATIN; GABAPENTIN; TOPIRAMATE; AMITRIPTYLINE; AIMOVIG,,Medical History/Concurrent Conditions: Blood pressure high; Chronic headaches; Heart disorder (minor heart condition); High cholesterol,,,"['Chills', 'Dehydration', 'Fall', 'Fracture', 'Head injury', 'Nausea', 'Pyrexia', 'Syncope']",2,PFIZER\BIONTECH, 1093335,,62.0,F,"Shortness of breath; joint pain in hands; Headache; coughing with extreme pain and described a feeling of bugs crawling in her lungs, bugs front and back/ painful cough; itching; This is a spontaneous report from a contactable nurse. This case was also received from Pfizer sponsored program. A 62-year-old female patient received the 2nd dose (at the age of 62-years-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# not provided), via an unspecified route of administration in Feb2021 at SINGLE DOSE for COVID-19 immunization. Medical history included lung and back problems (back pain). It was reported that the patient normally took an inhaler (not steroid inhaler because she didn't want to interfere with immune response), and other things. The patient previously took prednisone which started at 40mg for 2 days, 30 for 2 days, 20 for 2 days then goes down to zero for back pain (stopped taking 4 days before the second dose of the vaccine). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot# not provided) on 29Jan2021 (at the age of 62-years-old) for COVID-19 immunization. The patient's 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE was administered a week ago (Feb2021) Friday. It was reported that she got very ill initially which she said joint pain in hands and headache noted in Feb2021 (Saturday) which wasn't so bad. On Saturday afternoon, she reported shortness of breath, coughing with extreme pain (painful cough) and described a feeling of bugs crawling in her lungs, bugs front and back, and itching, and no one else reported it. The patient kept sleeping and waking up, thinking she was alright, but the coughing and lasted until Sunday evening, it was a very painful cough, and a creeping sensation in lungs front and back. She missed work on Monday. The events (joint pain in hands, headache, shortness of breath, coughing with extreme pain (painful cough) and itching) were medically significant as she was unable to go to work. It was also mentioned that since the patient stopped taking the Prednisone 4 days before the second dose of the vaccine. The patient had an exacerbation of pain (it came back). The patient was also wondering when can she start the inhaler and steroid for the back as she has lung and back problems. Outcome of the events were unknown. Information on lot number/batch number has been requested.; Sender's Comments: Based on data provided, the reported events are assessed as possibly related to BNT162B2. This case will be reviewed upon receipt of further information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Back pain; Lung disorder NOS,,,"['Arthralgia', 'Cough', 'Dyspnoea', 'Headache', 'Pruritus']",2,PFIZER\BIONTECH, 1093337,OH,85.0,F,"was in so much pain she was crying; Right ankle and foot was swollen and shiny/wrist was swollen and shiny/knee was swollen and shiny; knee was shiny with a lump she did not have before; arm, hand was swollen and shiny/foot was swollen; right elbow is messed up/its swollen and stiff; right elbow is messed up/its swollen and stiff; This is a spontaneous report from a contactable consumer. An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), first dose on 28Jan2021 at 12:30 then second dose at 18Feb2021 at 11:25, both via an unspecified route of administration at a single dose on left arm for COVID-19 immunisation. Medical history included diabetes mellitus (diagnosed 40 years ago) and a heart condition (had 5 stents, angioplasty, open heart surgery, clarified as triple bypass, in 98, 7 heart caths- 2 of them in one day, a stroke and a heart attack) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had the vaccine, the second one on 18Feb2021, last Thursday. She was in the hospital yesterday. On 21Feb2021, the patient experienced her right ankle and foot was swollen and shiny, her knee was swollen and shiny and knee was shiny with a lump she did not have before, arm, hand and wrist were swollen and shiny and her shoulder, and her right elbow was messed up. The doctor is the current county health advisor, he said to report all these things. On 21Feb2021, the patient was in so much pain she was crying. She went to the emergency room because it hurt so bad and then was admitted and kept overnight. The patient was put on prednisone to help with swelling. The patient's right elbow being messed up is improved and persisting, its swollen and stiff. The outcome of the events knee was shiny with a lump she did not have before and pain was recovering, right elbow messed up was not recovered, while of the rest was unknown. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/28/2021,02/21/2021,24.0,SEN,,,"Medical History/Concurrent Conditions: Diabetic (Diagnosed 40 years ago.); Heart disorder (5 stents, angioplasty, open heart surgery, a stroke and a heart attack)",,,"['Arthropathy', 'Joint stiffness', 'Joint swelling', 'Pain', 'Peripheral swelling']",1,PFIZER\BIONTECH, 1093338,OH,,U,"lymph nodes so big hard to swallow on left side and could not lay down; lymph nodes so big hard to swallow on left side and could not lay down; sore arm/arm hurt badly; couldn't sleep/hard to sleep; felt right side of body start to swell/Neck underarm shoulder; Painful lymph nodes/tender nodes; diarrhea through tout day; sore muscles; Tired low energy; Tired low energy; bad headache all over head; This is a spontaneous report from a contactable consumer who reported about self that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in upper right arm on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that Thursday 10:00 vaccine upper right arm. Felt fine very sore arm couldn't sleep because arm hurt badly. Friday went for easy walk at around 1:30 and felt right side of body start to swell. Neck underarm shoulder patient took 400 mg ibuprofen (MOTRIN). Took MOTRIN again before bed. Painful lymph nodes hard to sleep with MOTRIN. Saturday lymph nodes painful and diarrhea through tout day and evening sore muscles. Tired low energy. Saturday night lymph nodes so big hard to swallow on left side and could not lay down. Took 800 mg MOTRIN and was able to swallow better. And able to sleep with mild pain. Sunday lymph nodes decreased in pain and size. Was feeling better as day went on. Took MOTRIN for bed diarrhea stopped. Monday woke up with bad headache all over head. And still tender nodes but decreased in size. Patient went to doctors to make sure it wasn't something else. Doctor confirmed vaccine immune response. Return in 2 weeks. Outcome of the event diarrhea was recovered/resolved; of headache was unknown; while of remain was recovering/resolving. Information on the lot/ batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Asthenia', 'Diarrhoea', 'Dysphagia', 'Fatigue', 'Headache', 'Insomnia', 'Lymph node pain', 'Lymphadenopathy', 'Myalgia', 'Pain in extremity', 'Swelling']",UNK,PFIZER\BIONTECH, 1093339,AZ,98.0,M,"blood oxygen level dropped; chills and shaking; severe coughing; chills and shaking; profound leg weakness; This is a spontaneous report from a contactable consumer (patient). A 98-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Right arm (at age of 98-year-old) on 19Feb2021 at 12:30 PM as a single dose for COVID-19 immunisation, lot number: EL9267. Medical history included normal incident to old age. Patient had no known allergies. It was reported that patient received other medications in two weeks prior to the vaccination, no further details provided. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On unknown date in Feb2021 at 10:30 PM patient experienced severe coughing, chills and shaking, blood oxygen level dropped, profound leg weakness. Events resulted in Doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event). Patient was treated for the events, hospice was called, oxygen machine was attached. Patient was not tested for Covid post vaccination. Patient was recovering from the events, at the time of the report.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/19/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: General physical health deterioration,,,"['Chills', 'Cough', 'Muscular weakness', 'Oxygen consumption decreased', 'Oxygen saturation', 'Tremor']",1,PFIZER\BIONTECH, 1093348,FL,66.0,M,"Platelet count low; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. El3247) at single dose, in the right arm, on 08Feb2021 at 15:45, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included HIV disease; cancer (6 years before this report) and small stroke on an unspecified date, in 2019. No known allergies were reported. The patient previously, on 18Jan2021, at 02:00 PM, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. El8982) at single dose, in the left arm, for COVID-19 immunisation. Concomitant medications included metoprolol tartrate, rosuvastatin, gabapentin and cobicistat, darunavir ethanolate, emtricitabine, tenofovir alafenamide fumarate (SYMTUZA). On 17Feb2021, the patient had platelet count low and hospitalization was required (duration of hospitalization: 9 days). Normal range of 157000 platelets from blood work completed in Oct2020 that went to a dangerous level of 3800 confirmed on 17Feb2021. Treatment was received (platelets, IVIG infusions and prednisone). Post the vaccination, the patient has been tested for COVID-19 (Nasal Swab) on 23Feb2021 and resulted negative. The adverse event was assessed as serious (hospitalization and life-threatening illness, immediate risk of death from the event). The patient did not recover from the adverse event at time of this report.",Not Reported,,Yes,Yes,9.0,Not Reported,N,02/08/2021,02/17/2021,9.0,PVT,METOPROLOL TARTRATE; ROSUVASTATIN; GABAPENTIN; SYMTUZA,,Medical History/Concurrent Conditions: Cancer (6 years before this report); HIV disease; Stroke,,,"['Platelet count', 'Platelet count decreased', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1093414,NC,79.0,M,"Patient received 2nd dose of Moderna COVID vaccine at approx. 10am on 03/10/21. At approx. 5pm on 03/10/21, he developed typical side effects including fever, chills, and lethargy. Additionally, he became confused. The next morning, he remained lethargic and minimally responsive. He was febrile to 106 F per daughter and somewhat hypotensive with SBP into the 80s. The afternoon of 03/11/21, he also developed right facial droop and weakness. EMS was called and he was found to have suffered a left MCA stroke. He was admitted to the hospital for this and underwent thrombectomy. Of note, he was febrile and hypotensive on admission.",Not Reported,,Yes,Yes,,Yes,N,03/10/2021,03/10/2021,0.0,OTH,"1. allopurinol (allopurinol), 200 mg every day 2. apixaban (Eliquis 5 mg oral tablet), 1 tablet by mouth two times a day 3. aspirin (aspirin 81 mg oral tablet), 1 tablet by mouth every day 4. hydroCHLOROthiazide (hydroCHLOROthia",,Aortic stenosis s/p TAVR Hypertension Hyperlipidemia Atrial fibrillation Prior TIA Chronic diastolic heart failure Gout,,Penicillin - anaphylaxis,"['Asthenia', 'Cerebral artery occlusion', 'Cerebrovascular accident', 'Chills', 'Computerised tomogram head abnormal', 'Confusional state', 'Facial paralysis', 'Hyporesponsive to stimuli', 'Hypotension', 'Lethargy', 'Platelet count decreased', 'Pyrexia', 'Thrombectomy', 'Thrombocytopenia']",2,MODERNA,IM 1093418,MN,94.0,M,"After pt received first dose of Moderna on January 27, 2021, he experieced continuous increased decline in his health , with symptoms of increased difficulty swallowing, increased coughing, at least one episode of choking with expulsion of food; increased difficulty walking with walker, increased shortness of breath. On Wednesday, Feb. 24, at 7:50 a.m. , Pt was in wheelchair exiting home, on way to detached garage, being pushed by his daughter, when he slumped over, stated that he couldn't breathe, and went unconscious. Pt. did not have a detectable pulse . EMT was called and upon arrival performed CPR and obtained a pulse. Pt was transported to local hospital, where, again he lost pulse and was resuscitated again with mechanical CPR. Pt was supported with blood pressure medicine and ventilator until 7:53 p.m. when his heart stopped again. Pt. passed at that time.",Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/24/2021,28.0,PVT,Nat available at this time,"In January 2021, pt had a follow up PET scan with his oncologist, and that was reported as clear , with no signs of lung cancer. Pt had been treated for stage 3 lung cancer in January and February of 2020.",Adult onset hypertension; COPD seconda;ry to Lung Cancer dx in 11/2019.,,,"['Cardiac arrest', 'Choking', 'Cough', 'Death', 'Dysphagia', 'Dyspnoea', 'Gait disturbance', 'General physical health deterioration', 'Loss of consciousness', 'Mechanical ventilation', 'Positron emission tomogram', 'Posture abnormal', 'Pulse absent', 'Resuscitation', 'Walking aid user', 'Wheelchair user']",1,MODERNA,SYR 1093421,CA,34.0,F,Supraventricular Tachycardia,Not Reported,,Not Reported,Not Reported,,Yes,N,12/24/2020,01/01/2021,8.0,PVT,"Zyrtec, Singulair, Effexor",Had baby august 2020,"Exercise induced asthma, seasonal allergies",,Contact dermatitis with certain soaps,"['Echocardiogram', 'Electrocardiogram abnormal', 'Supraventricular tachycardia']",UNK,MODERNA, 1093448,,66.0,M,"CVA, confirmed by MRI",Not Reported,,Yes,Yes,,Not Reported,Y,02/22/2021,03/03/2021,9.0,PVT,Insulin Lisinopril-HCTZ atorvastatin,,"Diabetes, HTN, HLD",,Sulfa antibiotics,"['Cerebrovascular accident', 'Magnetic resonance imaging abnormal']",UNK,PFIZER\BIONTECH, 1093451,PA,47.0,F,Acute Pulmonary Embolism with lung infarct,Not Reported,,Yes,Yes,,Not Reported,N,03/04/2021,03/10/2021,6.0,PVT,None,None,None,,None,"['Computerised tomogram thorax', 'Pulmonary embolism', 'Pulmonary infarction', 'Scan with contrast']",2,MODERNA,IM 1093460,CA,22.0,M,"On Thursday, March 11th, 2021 approximately 3:10 pm, Patient received his first dose of Moderna Vaccine (Lot number: 003A21A) in his left deltoid Patient received the Moderna Vaccine. After which he sat in the designated medical observation area for 15 minutes. Approximately five minutes later around 3:15 pm, Patient experienced syncope, fell out of his chair, hit the left side of his forehead on the ground. Due to the fall, he experienced a mild abrasion on the left side of his forehead, which led to bleeding. The Physician?s Assistant rushed to aid Patient who was lying on the ground in a supine position. Emergency Medical Services (EMS) - Fire Department and ambulance were called immediately and approximately five minutes later EMS arrived. During the time frame prior to EMS arrival, the Physician?s Assistant asked numerous questions to Patient to assess his condition. She asked Patient if he could breathe and he responded ?yes?. She asked Patient if he was short of breath and he responded ?no?. She asked Patient if he felt like his throat was closing and he responded ?no?. At this point, an Epinephrine pen was not used. Patient was alert and the Orient x 4 questions were asked [(1) Who are you? (2) Where are you? (3) What is the date and time? (4) What just happened to you?]. Patient also denied head pain, neck pain, nausea or chest pain. Staff performed a limited neuro-exam and was deemed within normal limits. Patients Glasgow Coma Scale score was 15 Patient mentioned that he has a phobia of needles and something like this has happened before when he was ?young?. Patient initially did not want an ambulance to be called. It was explained to him that it might be in his best interest to call EMS due to syncope and abrasion on his forehead due to the fall. Patient also mentioned that he only consumed two cookies and coffee for that day. When the EMS arrived (about 5 firefighters), they interviewed him and performed a blood pressure test. His sitting blood pressure was 130/82. One of the firefighters assessed his spine and Patient denied cervical, thoracic, and lumbar tenderness or pain. The firefighter assessed Patient's glucose level, which was a bit difficult to obtain in the first initial efforts, with the glucometer reading ?error?. The firefighters eventually were able to obtain a reading on Patient's glucose and it read 86. Patient was able to stand on his own, and a second blood pressure test was performed; his standing blood pressure reading was 145/89. EMS gave Patient gauze to address his head wound Patient initially refused to go to the hospital, but per EMS protocol, fluids needed to be administered. Patient entered the ambulance and was taken to the hospital by EMS.",Not Reported,,Not Reported,Yes,,Not Reported,U,03/11/2021,03/12/2021,1.0,OTH,NONE,NONE,NONE,,NONE,"['Blood glucose normal', 'Fall', 'Fear of injection', 'Haemorrhage', 'Head injury', 'Skin abrasion', 'Syncope']",1,MODERNA,IM 1093489,SC,65.0,F,"3""rash around site, chills and fever after 30 minutes of injection, fever for 36 hrs, then hives started on Monday 3/1, Went to emergency in early evening they gave me intravenous meds and released me 3 hours later. On Tues 3/2/21 about 5:00 pm hives and itching continued and got worst. I went back to emergency and they treated me will pill form medications and released me about 3 hours later. I was still with hives and some itching. On Wed morning 3/3/21 I woke up with severe hives and itching and my face and lips had now blown up and were getting worst. about 3 times the size. We returned to Hospital and the admitted me. I stayed untill Sat morning 3/6/21. I was treated with high doses of steroids, wore a heart monitor because my heart rate dropped to 40 at night.",Not Reported,,Not Reported,Yes,4.0,Not Reported,Y,02/26/2021,02/26/2021,0.0,PVT,"Famotidine, calcium w/ D3, Docusate sodium, multi vitamin,Glucosamine HCI, Isprapium Bromide spray, flonase.",none,none,,"Yellow dye, erythromycin, codeine, morphine.","['Blood test', 'Cardiac monitoring', 'Chills', 'Heart rate decreased', 'Injection site rash', 'Lip swelling', 'Pruritus', 'Pyrexia', 'Swelling face', 'Urticaria']",1,MODERNA,IM 1093498,RI,68.0,M,"Site: Swelling at Injection Site-Severe, Systemic: DVT-Severe, Additional Details: Patient presented to office with swelling of right upper extremity occuring after first COVID 19 vaccine dose. Was sent for duplex study which revealed acute deep vein thrombosis in right subclavian and axillary veins and superfficial thrombophlebitis of basilic vein in right arm. Pharmacy was contacted 3/10/2021 by MD at hospital to report vaccine adverse event",Not Reported,,Not Reported,Yes,,Not Reported,U,03/02/2021,03/09/2021,7.0,PHM,,,,,,"['Deep vein thrombosis', 'Injection site swelling', 'Thrombophlebitis', 'Ultrasound Doppler']",1,MODERNA,IM 1093561,FL,62.0,M,Loss use of entire right side,Not Reported,,Not Reported,Yes,1.0,Yes,U,03/05/2021,03/05/2021,0.0,MIL,Spironolactone 25mg Ferrous Sulfate 65mg Aspirin EC 81mg Lisinopril 20mg Potassium CHL ER 8meq,None,High blood pressure,,None,['Hemiplegia'],1,MODERNA,SYR 1093562,VA,67.0,F,"None with first shot. Just tender arm at injection site. After the noonday second shot 2/25/2021 , within 24 hrs. I was awaken with ringing in my ears which still continues today.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/28/2021,02/26/2021,29.0,PVT,Daily vitamin. Citrical.,,,,Amoxicillin. Epinephrine.,"['Ear, nose and throat examination', 'Injection site pain', 'Sleep disorder', 'Tinnitus']",1,MODERNA,SYR 1093588,FL,67.0,M,"vaccination site erythema; vaccination site pain; Vaccine underdoes; syringe connection issue; A spontaneous report was received from a consumer concerning a 67-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) . The patient medical history was not provided. Concomitant medications were not provided. On 15 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscular in the left upper arm, for prophylaxis of COVID-19 infection. On 15 Feb 2021, during vaccination patient felt the dose dripping down the arm, 8 hours after vaccination, the patient had pain around the deltoid area (shoulder and arm) on the left side and noticed a bruise at the injection site. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/15/2021,02/15/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Device connection issue', 'Underdose', 'Vaccination site erythema', 'Vaccination site pain']",1,MODERNA,OT 1093597,,51.0,F,"She reports history of Moderna vaccination on Friday, March 5th. It was her second dose. She felt awful within an hour of vaccination and persisted with symptoms for 2.5 days. She described it as being out of it, headache, fever, chills, profound body aches, weakness and dizziness with palpitations. She could not get out of bed for a day. She literally thought she was going to die given the severity of her weakness. As quickly as the symptoms occurred, they left her on March 7th, 2021. She went to work on March 8th and noted similar symptoms to prior ITP flares - petechiae on legs, gum bleeding, fatigue, mild headache. She also noted dark urine but no frank blood. Since being admitted and receiving steroids, she is feeling improved and petechiae are lessening. She also noted mild mouth ulceration to lower lip along with oozing.",Not Reported,,Not Reported,Yes,5.0,Not Reported,N,03/05/2021,03/05/2021,0.0,PVT,"ergocalciferol (VITAMIN D) 1,250 mcg (50,000 unit) capsule, Take 50,000 Units by mouth Take once weekly. On sundays estradioL (ESTRACE) 0.5 MG tablet, Take 0.5 mg by mouth daily. eszopiclone (LUNESTA) 2 mg Tablet, Take 2 mg by mouth da",none,"She has a past medical history of Anxiety, Depression, GERD (gastroesophageal reflux disease), History of ITP, and Insomnia. �Patient has history of ITP x 11 years. Noted worsened petechiae in past day and went to PCP, platelets 36,000 as outpatient and directed for admission due to gum bleeding and dark stools. She reports past successful treatment with intermittent steroids, last flare in past year. Her baseline levels prior to this flare were closer to 100,000 although in past years she did fine at platelet 30-40,000 without bleeding.",,none,"['Asthenia', 'Chills', 'Chromaturia', 'Computerised tomogram head normal', 'Dizziness', 'Fatigue', 'Feeling abnormal', 'Gingival bleeding', 'HIV test negative', 'Haematocrit normal', 'Haemoglobin normal', 'Headache', 'Hepatitis C test negative', 'Lip ulceration', 'Mean cell haemoglobin concentration normal', 'Mean cell volume normal', 'Mean platelet volume increased', 'Mobility decreased', 'Pain', 'Palpitations', 'Petechiae', 'Platelet count decreased', 'Pyrexia', 'Red blood cell count normal', 'Red cell distribution width normal', 'Respiratory viral panel', 'SARS-CoV-2 test negative', 'Vitamin B12', 'White blood cell count normal']",2,MODERNA,IM 1093645,MD,86.0,F,"On 3/7/21 the patient presented to the ED with abdominal pain. Reason for admission: diverticulitis. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine. This hospitalization does not appear to be related to the vaccine.",Not Reported,,Not Reported,Yes,,Not Reported,,03/02/2021,03/07/2021,5.0,PVT,"Omega-3 fatty acids-fish oil, Vitamin A,C,E/lutein/minerals, quinapril 40 mg BID",,"hypertension, acid reflux, hypothyroidism",,amlodipine and carvedilol,"['Abdominal pain', 'Diverticulitis']",1,PFIZER\BIONTECH,IM 1093654,PA,19.0,F,"Syncope/Collapse 20 minutes after receiving the vaccine I was in AFIB and had a heart rate of 150, hospitalized overnight. Been dealing with high HR ever since, which has hindered my ability to run and train at my normal level. Had to wear a heart monitor for two weeks. Followed up with my cardiologist; have to get an echocardiogram done and then an electrophysiology test/heart cath done in the near future.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,01/14/2021,01/14/2021,0.0,PVT,Allegra Singulair Ocella Nortriptyline,,IBS C/D Migraines,,,"['Atrial fibrillation', 'Cardiac monitoring abnormal', 'Chest X-ray normal', 'Echocardiogram normal', 'Electrocardiogram abnormal', 'Exercise tolerance decreased', 'Heart rate increased', 'Supraventricular tachycardia', 'Syncope', 'Ventricular extrasystoles']",1,MODERNA,IM 1093663,MA,73.0,F,"3/6 vaccination. 6PM HA, neck pain, body aches, chills, fatigue; 12:AM woke up with increased HR. HR was too fast; up to 178-200. 911 called by husband. A fib with rapid pulse, convert with IV medicines. Low potassium and magnesium levels. Nitro administer by husband before EMS arrived; had gone down by time ambulance arrived by was irregular. Kept me in observation floor. *still not feeling 100%; fatigue, high HR",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,03/06/2021,03/07/2021,1.0,OTH,"Cardizem ER, eloquence, levothyroxine, pantoprazole, remidine eye drops, timolol eye drops, vit D, biotin, Tylenol (did not take for couple days before), ProAir & Advair inhalers, nitrice prn",,"heart disease, lupus, hypertension, neuropathy, afib",pneumonia vaccine 8 years prior; rash.,"opioid pain medication, clindamycin, Bactrim, fluorine, walnuts, kiwis, statin for cholesterol (stomach issues)","['Atrial fibrillation', 'Blood magnesium decreased', 'Blood potassium decreased', 'Chills', 'Electrocardiogram', 'Fatigue', 'Feeling abnormal', 'Headache', 'Heart rate increased', 'Neck pain', 'Pain']",1,JANSSEN,SYR 1093666,MN,66.0,F,Client Passed away on 1/28/2021,Yes,01/28/2021,Not Reported,Not Reported,,Not Reported,U,01/21/2021,01/28/2021,7.0,PUB,unknown,,unknown,,unknown,['Death'],1,MODERNA,IM 1093686,MD,89.0,F,On 3/6/2021 the patient presented to the ED with dyspnea and substernal chest pain that pretty much resolved as soon as she came in. She was admitted to rule out any cardiovascular events (none were apparent). Reason for admission: chest pain.,Not Reported,,Not Reported,Yes,4.0,Not Reported,,03/04/2021,03/06/2021,2.0,PVT,,,"CHF, CKD stage 2, and asthma",,Levofloxacin,"['Chest pain', 'Dyspnoea']",2,MODERNA,IM 1093698,LA,64.0,F,Seizure like activity within minutes after vaccine; pt does have history of seizure disorder as well as some non-epileptic spells,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/25/2021,02/25/2021,0.0,PVT,"Lipitor, Plavix, Aspirin, Lopid, Metformin, Tresiba, Primidone, Keppra, Dilantin, Depakote, Zoloft, Lasix, Losartan Toprol",,"CAD, DM2, CVA, seizure disorder, pseudoseizures, depression, anxiety, polio",,Codeine,"['Electroencephalogram', 'Seizure', 'Seizure like phenomena']",1,PFIZER\BIONTECH,IM 1093701,TX,38.0,M,"16:00 -Patient started running a fever of 102. He c/o chills, fatiigue, severe body aches, vomiting. Pt was admitted to hospital. Treated symptomatically with IV Tylenol, toradol, Zofran, and fluids",Not Reported,,Not Reported,Yes,,Not Reported,,03/11/2021,03/11/2021,0.0,OTH,Lexapro Tylenol #3 Xanax 0.25 mg Hydrocortisone 20 mg Tramadol 50 mg,Adrenal Insuffciency,Adrenal insuffciency,,No known allergies noted,"['Chills', 'Fatigue', 'Pain', 'Pyrexia', 'Vomiting']",1,JANSSEN,IM 1093731,MD,81.0,F,"On 3/7/2021 the patient presented to the ED with generalized weakness and altered mental status. She was admitted for hyponatremia and found to have a UTI. Per EUA, all hospitalization must be reported after receiving a vaccine. This hospitalization does not appear to be related to the vaccine.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,02/16/2021,03/07/2021,19.0,PVT,,Pancreatic cancer,"hypertension, hyperlipidemia, hypothyroidism, osteoporosis, anxiety/depression, malignant pancreatic cancer",,"bupropion, pseudoephedrine, metoclopramide, lisinopril","['Asthenia', 'Hyponatraemia', 'Mental status changes', 'Urinary tract infection']",2,MODERNA,IM 1093762,NH,101.0,F,3/12/2021-EXPIRED AT FACILITY ON HOSPICE SERVICES,Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,02/18/2021,03/12/2021,22.0,SEN,Acetaminophen Tablet 500 MG QHS; Aspirin Tablet 81 MG QD; CeleXA Tablet 20 MG QD; GlycoLax Powder (Polyethylene Glycol 3350) Give 17 gram QD; PredniSONE Tablet 2.5 MG(JUST COMPLETED 3 WEEK LOW DOSE TAPER ON 2/15);Remeron Tablet (Mirtazapin,"NO ACUTE MEDICAL ISSUES. RESIDENT ON HOSPICE SERVICES FOR END STAGE ALZHEIMER'S DEMENTIA SINCE 6/11/2020 WITH OVERALL POOR ORAL INTAKE, WEIGHT LOSS AND DECLINE. COVID NEGATIVE AND NO HX OF COVID-19. RECEIVING REGULAR HOSPICE SERVICES FOR CARE, COMFORT AND PAIN MANAGEMENT. COMPASSIONATE VISITS WITH DAUGHTER. IMPULSIVE WITH POOR SAFETY AWARENESS AND MULTIPLE FALLS.","ALZHEIMER'S DISEASE, UNSPECIFIED DYSPHAGIA, UNSPECIFIED ACUTE ON CHRONIC DIASTOLIC (CONGESTIVE) HEART FAILURE POLYMYALGIA RHEUMATICA ESSENTIAL (PRIMARY) HYPERTENSION HYPOTHYROIDISM, UNSPECIFIED OTHER CHRONIC PAIN UNSPECIFIED MOOD [AFFECTIVE] DISORDER ABDOMINAL AORTIC ANEURYSM, WITHOUT RUPTURE NEOPLASM OF UNCERTAIN BEHAVIOR OF CONNCTV/SOFT TISS ENCOUNTER FOR PALLIATIVE CARE OTHER INTERVERTEBRAL DISC DEGENERATION, LUMBAR REGION CERVICAL DISC DISORDER, UNSP, UNSPECIFIED CERVICAL REGION ACTINIC KERATOSIS DEMENTIA IN OTH DISEASES CLASSD ELSWHR W/O BEHAVRL DISTURB MAJOR DEPRESSIVE DISORDER, SINGLE EPISODE, UNSPECIFIED HYPERLIPIDEMIA, UNSPECIFIED SECONDARY MALIGNANT NEOPLASM OF SKIN",,"CODEINE, OXYCODONE","['Death', 'SARS-CoV-2 test negative']",2,PFIZER\BIONTECH,IM 1093782,MD,75.0,F,"On 3/7 the patient presented to the ED after having 3 episodes of presyncopal staring events in the past week, and reports having them over the past year and a half. Reason for admission: syncope and collapse. Per, EUA all hospitalizations must be report after recently receiving a vaccine. This patient has had a history of syncope and this hospitalization does not seem to be related to the vaccine.",Not Reported,,Not Reported,Yes,4.0,Not Reported,,03/04/2021,03/07/2021,3.0,PVT,"albuterol HFA, alendronate, alprazolam, aspirin, buspirone, vitamin D2, fexofenadine, Flonase, hydrochlorothiazide, levetiracetam, metoprolol tartrate, omeprazole, potassium chloride, sertraline, simvastatin, tizanidine, zolpidem.",,"Coronary artery disease, anxiety/depression, asthma, hypertension, hyperlipidemia, GERD, osteoarthritis,",,Morphine,"['Presyncope', 'Staring', 'Syncope']",2,PFIZER\BIONTECH,IM 1093791,KY,84.0,F,Unknown,Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,01/21/2021,02/01/2021,11.0,OTH,"Lipitor, Breo Ellipta Inhaler, Ticagrelor, Coreg, Lasix, Isosorbide mononitrate, Cozaar, Singulair, K-Dur",,"COPD, TIA, DM II, Afib",,,['Death'],2,PFIZER\BIONTECH,IM 1093795,NY,82.0,M,Detected afib the morning by taking my pulse after the Pfizer shot #2. Treated by cardioversion #9.,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/19/2021,02/20/2021,1.0,OTH,metropol tartrate amlodipine besylate levetiracetam atrovastatin vitamin D vitamin B aspirin 81 mg testosterone 1%,none,afib,,none,"['Atrial fibrillation', 'Cardioversion']",2,PFIZER\BIONTECH,IM 1093824,MD,85.0,F,On 3/7/2021 the patient presented to the ED with chest pain lasting for about a week that was not relieved after taking nitroglycerin. The patient does have a history of coronary artery disease. The patient was admitted for NSTEMI.,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/25/2021,03/07/2021,10.0,PVT,"alprazolam, aspirin, furosemide, lisinopril, metoprolol succinate, nitroglycerin, ondansetron, sertraline, multivitamin, warfarin",,"hypertension, afib, history of DVT/PE, anemia",,"fentanyl, hydromorphone, nortriptyline, captopril, atorvastatin, cipro, codeine, quinapril, metformin, fosinopril","['Acute myocardial infarction', 'Chest pain']",1,MODERNA,IM 1093838,CA,38.0,F,"7pm fever 103.4� chills, tremors, vomiting. Fever remained for 2 days, low back and abdominal pain became increasingly worse. Finally went to ER 2/26 was septic hospitalized for 13 days",Not Reported,,Yes,Yes,13.0,Not Reported,,02/17/2021,02/17/2021,0.0,PVT,"Wellbutrin, Sulfasalazine",,Ulcerative colitis,,None,"['Abdominal pain', 'Back pain', 'Chills', 'Pyrexia', 'Sepsis', 'Tremor', 'Vomiting']",2,MODERNA,IM 1093843,FL,92.0,F,patient's daughter reported patient passed away 2 days after first dose of vaccine,Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/14/2021,2.0,PHM,,,,,no known allergies,['Death'],2,MODERNA,IM 1093852,OH,77.0,M,Flare up of urticaria and angioedema Has chronic urticaria,Not Reported,,Not Reported,Yes,,Not Reported,Y,03/08/2021,03/09/2021,1.0,UNK,,,,,,"['Angioedema', 'Condition aggravated', 'Urticaria']",UNK,MODERNA, 1093857,MS,74.0,M,"According to the patient's wife, the patient had flu like symptoms 2/11/2021. Complaints: Thirsty, sweaty and seizure with no prior history. Died at home. Not sent to hospital. Pronounced by coroner",Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/12/2021,2.0,OTH,Unknown,Unknown,HTN; Stroke,,Unknown,"['Death', 'Hyperhidrosis', 'Influenza like illness', 'Seizure', 'Thirst']",1,PFIZER\BIONTECH,IM 1093865,IA,86.0,M,"He was brought into the ER via EMS for altered mental status. He does have an underlying dementia but is normally able to hold a conversation and take care of himself. He was standing at kitchen sink staring off and drooling from his mouth. He was not able to answer questions, unable to find the words, and was weak. Admitted to hospital.",Not Reported,,Not Reported,Yes,,Not Reported,U,03/10/2021,03/11/2021,1.0,PUB,"Namenda, ASA, Multivitamin, senna, travoprost opthalamic",none,"Dementia, Glaucoma",,codeine,"['Aphasia', 'Asthenia', 'Blood creatinine', 'Blood glucose increased', 'Blood urea', 'Computerised tomogram normal', 'Drooling', 'Electrocardiogram normal', 'Mental status changes', 'Staring', 'Troponin increased', 'White blood cell count increased']",2,MODERNA,IM 1093869,ND,79.0,F,"severely cold, short of breath, exhaustion, muscle pain, nausea, fast heart rate, dizzy, weak",Not Reported,,Yes,Yes,7.0,Yes,N,01/23/2021,02/14/2021,22.0,PVT,"Heart medication, High blood pressure (client does not have her full list handy)",no - very healthy worked out at the gym 4x a week prior to vaccinations,Heart condition (5 way heart bypass-11 years ago),,no,"['Aspiration pleural cavity', 'Asthenia', 'Chest X-ray', 'Colonoscopy', 'Dizziness', 'Dyspnoea', 'Echocardiogram', 'Endoscopy', 'Fatigue', 'Feeling cold', 'Gastrointestinal examination', 'Haemoglobin decreased', 'Heart rate increased', 'Mononeuropathy', 'Myalgia', 'Nausea', 'Peroneal nerve palsy']",2,PFIZER\BIONTECH,IM 1093875,KS,73.0,M,"History of Present Illness The patient presents with weakness. The course/duration of symptoms is constant. The character of symptoms is generalized. The degree at present is moderate. Associated symptoms: abdominal pain. 73 y/o M who comes in from home for generalized weakness. PT states that he was feeling well until after he went to bed tonight. around 1 am he attempted to get up and go to the bathroom and his wife had to help him. She was able to get him up and he went to the bathroom but he seemed more shakey than usual. He then tried to get back up around 230 am and he was very shakey, said he was cold, and he could tno stand. She attempted to stand him up and she was not able to get him up and move him at all because he was so generally weak. No fevers that he knows of. He did recieve his first dose of the covid vaccine this afternoon. He was well after that and went to dinner and was well until he went to sleep. He has a h/o HTN, HLD, and tremor. Pt did have covid in early december as well. . Notes: 73 y/o M who comes in from home for generalized weakness. Pt is alert and awake but slower to respond than his usual per his wife. Labs are overall reassuring. His etemp is elevated but afebrile. CXR with possible atelectasis vs infiltrate but pt has no cough, no fever, and a normal WBC Coutn so I favor atelectasis. His CT head shows possibly artifact vs cortical hypodensities. Will await formal read this morning. Pts UA is clean. He is no longer shaking after a dose of tylenol and ativan. I suspect the pts generalzied weakess is 2/2 his recent covid vaccine yesterday afternoon. Despite this the pt cannot stand and move around on his own and his wife cannot care fo rhim at home given his current situation. Pt discussed with Dr and will be admitted for further care. . Impression and Plan Diagnosis COVID-19 vaccine series started Rigors Tremor Weakness Weakness or fatigue Plan Condition: Improved, Stable. Disposition: Admit time 3/12/2021 06:27:00",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,03/11/2021,03/11/2021,0.0,PVT,,"Acute encephalopathy, anemia","bipolar disorder, CVA, CAD",,"Codeine, Fentanyl, Hydrocodone, Lisinopril, Metformin, Metoclopramide, Morphine, Primidone, Reglan, Simvastatin, Tramadol, Vicodin","['Abdominal pain', 'Asthenia', 'Atelectasis', 'Chest X-ray abnormal', 'Chills', 'Computerised tomogram head', 'Dysstasia', 'Fatigue', 'Feeling cold', 'Mobility decreased', 'Slow response to stimuli', 'Tremor', 'Urine analysis normal', 'White blood cell count normal']",UNK,MODERNA, 1093887,MD,83.0,F,"On 3/8/2021 the patient presented to the ED with stroke-like symptoms. Reason for admission: suspected TIA. Acute CVA-has been ruled out. Incidental finding CT head 9 x 5 mm lesion possibly meningioma, but scans of CTA head and neck no lesion, MRI of the brain shows no lesions.",Not Reported,,Not Reported,Yes,4.0,Not Reported,,03/01/2021,03/08/2021,7.0,PVT,"Atorvastatin, calcium-cholecalciferol, cetirizine, citalopram, diltiazem, levothyroxine, potassium chloride, Xarelto, Preservision AREDS",,"Afib, diabetes, hypertension, hypothroidism",,"Cefprozil, doxycycline, nabumetone, penicillins, sulfas","['Angiogram cerebral normal', 'Arteriogram carotid normal', 'Central nervous system lesion', 'Computerised tomogram head abnormal', 'Magnetic resonance imaging head normal', 'Neurological symptom', 'Transient ischaemic attack']",2,PFIZER\BIONTECH,IM 1093890,AZ,78.0,M,"He was fine until 2/22/2021. He suddenly started having left leg weakness. He started becoming more dizzy next day and skipped his daily walk. On 2/25/2021, his left leg weakness became worse. His wife gave him cane and took him to PCP who diagnosed him with BPPV and gave him meclizine. Next day, he started having jaw stiffness and had difficulty in brushing his teeth. He was complaining of blurry vision in both eyes. He denied any double vision. He stated he could not read things which he was able to read 2 days ago. A day before he presented to Hospital, he was not able to walk at all and he required walker. According to his wife, when she went to see him at Hospital around 7 PM on 03/05/2021, his oxygen saturation dropped twice and internist decided to transfer him to ICU. Later on, the decision was made to transfer him to Medical Center. Pt was intubated, developed diffuse segmental myoclonus, required intense sedation; /ivig ineffective, now giving plasmapheresis. pt underwent imaging of CNS, LP and extensive laboratory testing.",Not Reported,,Yes,Yes,12.0,Not Reported,N,02/10/2021,02/22/2021,12.0,OTH,"CHOLECALCIFEROL (VITAMIN D3) 1,000 UNIT TABLET, Oral, Daily CLOBETASOL 0.05 % TOPICAL CREAM, Topical, BID FOSINOPRIL 20 MG-HYDROCHLOROTHIAZIDE 12.5 MG TABLET MULTIVITAMIN TABLET, Oral, Daily OMEPRAZOLE 20 MG CAPSULE,DELAYED RELEASE TAZAROTE",none,"HTN, First degree AV block, DM, OSA on CPAP, Psoriasis, dyspepsia, Lumbar DDD, right TKR",,"acitretin, celecoxib","['Dizziness', 'Endotracheal intubation', 'Gait inability', 'Guillain-Barre syndrome', 'Imaging procedure abnormal', 'Immunoglobulin therapy', 'Intensive care', 'Intervertebral disc protrusion', 'Intervertebral disc space narrowing', 'Joint stiffness', 'Laboratory test', 'Loss of personal independence in daily activities', 'Lumbar puncture', 'Mobility decreased', 'Muscular weakness', 'Myoclonus', 'Oxygen saturation decreased', 'Plasmapheresis', 'Sedative therapy', 'Spinal osteoarthritis', 'Vertigo positional', 'Vision blurred', 'Walking aid user']",UNK,MODERNA, 1093921,PA,75.0,F,"She reports that she feels pain all over her body, reporting that her hands and feet feel stiff and tingly. She reports no weight changes, no cough, shortness of breath, PND, dysuria, swelling. Patient originally presented to the ED at hospital 3/1/2021 with a generalized body aches and pains of 1 day duration. In the ER, patient was hypertensive and labs showed elevated creatinine of 1.6 (baseline 1.27), BNP >8000. She describes her symptoms as a sub-acute onset hand and leg weakness. It appears that the leg symptoms started before the arms were affected, after which she developed positive sensory symptoms in the form tingling of the hands and feet. She also admits to negative symptoms in the form of decreased sensation of her feet. She has been unable to stand on her feet since about two days ago. She appears to have some disturbance in time perception as her recollection of the progression of her disease is off by several weeks. she denies bowel/bladder incontinence or saddle anesthesia.",Not Reported,,Not Reported,Yes,12.0,Yes,N,02/09/2021,03/01/2021,20.0,UNK,"Aspir-Low 81 mg oral delayed release tablet, 81 mg= 1 tab, Oral, Daily atorvastatin 10 mg oral tablet, 10 mg= 1 tab, Oral, Daily atorvastatin 10 mg oral tablet, 10 mg= 1 tab, Oral, Daily carvedilol 25 mg oral tablet, 25 mg= 1 tab,",Renal dysfunction elevated BUN of 49.5 and creatinine of 1.78.,CAD (coronary artery disease) CHF (congestive heart failure) Depression DM (diabetes mellitus) HTN (hypertension) Hypothyroid Renal cancer; s/p nephrectomy congenital atrophic kidney,,NKDA,"['Blood creatinine', 'Brain natriuretic peptide increased', 'Dysstasia', 'Hypertension', 'Intervertebral disc degeneration', 'Magnetic resonance imaging spinal abnormal', 'Muscular weakness', 'Musculoskeletal stiffness', 'Pain', 'Paraesthesia', 'Sensory disturbance', 'Sensory loss', 'Spinal stenosis', 'Time perception altered']",UNK,MODERNA, 1093939,MS,83.0,M,"No report of negative event after 15 min wait past receipt of vaccine. Notified by Coronor, on 3/11/2021 that this patient expired on 3/11/2021 at home. Not sent to hospital. Pronounced at home. Sent to Funeral Home",Yes,03/11/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/11/2021,6.0,PUB,Blood Thinner,Unknown,Unknown,,Unknown,['Death'],1,JANSSEN,IM 1093951,MD,84.0,F,"On 3/9/2021 the patient presented at the ED for hypoglycemia. It was found that the patient had hypoglycemia due to an unintentional overdose of insulin. Reason for admission: hypoglycemia. Per EUA, hospitalizations are must be reported after recently receiving a vaccine. This hospitalization does not appear to be related to the vaccine.",Not Reported,,Not Reported,Yes,2.0,Not Reported,,02/25/2021,03/09/2021,12.0,PVT,"aspirin, calcium-magnesium, Sinemet, carvedilol, vitamin D3, gabapentin, insulin, lorazepam, omega-3-fish oil, sertraline, simvastatin, temazepam, vitamin E, vitamin B complex",,"insulin-dependent diabetes, heart failure, hypertension, Parkinson's disease, peripheral neuropathy",,Sulfa antibiotics,"['Accidental overdose', 'Hypoglycaemia']",2,MODERNA,IM 1093960,GA,64.0,M,"I was awakened with severe chills,runny nose,hot head,nausea,short of breath,unable to walk because of severe shaking,blurred vision,slight headache,exhaustion",Not Reported,,Yes,Not Reported,,Not Reported,Y,03/10/2021,03/12/2021,2.0,PHM,"amlodipine , atorvastatin, Buspirone, Effexor, Ep Labetolol, Lamotrigine,eplerenone, gabapentin, Lisinopril,Minoxidil,protonix, potassium(prescription), tamsulosin, Benadryl for sleep. I have been taking the past 2 weeks the following med","depression,seizures,heart failure,igh bloodpressure high cholestrol","depression,seizures,heart failure,high b/p,high cholestrol",,"dilaudid,keflex,lortab,morophine,niaspan,pennicillan,tramadol,vicodin,reglan","['Blood glucose increased', 'Blood test abnormal', 'Chest X-ray abnormal', 'Chills', 'Dyspnoea', 'Fatigue', 'Feeling hot', 'Gait inability', 'Haematocrit decreased', 'Haemoglobin decreased', 'Headache', 'Nausea', 'Red blood cell count decreased', 'Red cell distribution width increased', 'Rhinorrhoea', 'Serum ferritin decreased', 'Sleep disorder', 'Tremor', 'Vision blurred']",1,MODERNA,SYR 1093961,TX,73.0,F,Death,Yes,03/08/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/08/2021,3.0,OTH,,,multiple miloma but in remission,,,['Death'],1,PFIZER\BIONTECH,SYR 1093969,AZ,76.0,M,"New onset Myasthenia gravis. Patient initially presented in the ED on 2/23/2021 with complaint of left facial droop, slurred speech and double vision. His stroke score was 2, for left facial droop. nAChR antibody test this test has come back positive, making it likely that this patients symptoms are due to acute myasthenia gravis. The patient continued to experience double vision and eye weakness associated with trouble swallowing that has continued to worsen and was brought the hospital for re-assessment at the request of his wife.",Not Reported,,Yes,Yes,4.0,Not Reported,N,02/01/2021,03/01/2021,28.0,UNK,"acyclovir 200 mg oral capsule, 200 mg= 1 cap, Oral, 5 times per day ALPRAZolam 0.5 mg oral tablet, See Instructions amLODIPine 5 mg oral tablet, 5 mg= 1 tab, Oral, Daily aspirin 81 mg oral delayed release tablet, 81 mg= 1 tab, Oral, Dail",none,"HTN, high cholesterol, insomnia",,NKDA,"['Antiacetylcholine receptor antibody positive', 'Blood thyroid stimulating hormone', 'Diplopia', 'Dysarthria', 'Dysphagia', 'Extraocular muscle paresis', 'Eyelid ptosis', 'Facial paralysis', 'Myasthenia gravis', 'Tyrosine kinase mutation assay']",UNK,MODERNA, 1093981,,38.0,M,"Vaccine 3/8/21 at 4:00 PM.Headache and fever 3 hours post vaccine. The following day had diarrhea and vomiting. Then presented to ER on 3/10/21 with lactic acidosis, & leukocytosis. Hospitalized for 24 hours 3/10/21 to 3/11/21.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,03/08/2021,03/08/2021,0.0,UNK,,,,,,"['Diarrhoea', 'Headache', 'Lactic acidosis', 'Leukocytosis', 'Pyrexia', 'Vomiting']",UNK,JANSSEN,IM 1093985,KY,68.0,F,"Patient hospitalized on 3/9/21 with one week history of fever, chills, and shortness of breath. Tested positive for COVID-19. Respiratory status worsened on 3/11 requiring transfer to ICU and intubation. Currently intubated in ICU.",Not Reported,,Yes,Yes,,Not Reported,N,03/02/2021,03/02/2021,0.0,PVT,,,"hypertension, diabetes type II, sleep apnea, restless leg syndrome, hyperlipidemia, chronic venous insufficiency",,,"['Blood lactic acid', 'C-reactive protein increased', 'COVID-19', 'Chills', 'Computerised tomogram thorax abnormal', 'Dyspnoea', 'Endotracheal intubation', 'Fibrin D dimer increased', 'Intensive care', 'Lymphadenopathy mediastinal', 'Pneumonia', 'Procalcitonin normal', 'Pyrexia', 'Respiratory distress', 'SARS-CoV-2 test positive', 'Serum ferritin increased']",1,PFIZER\BIONTECH,IM 1093986,LA,45.0,F,Received a phone call stating that the patient complained of not feeling well on 3/11/21 while at work and that the patient died that night while at home.,Yes,03/11/2021,Not Reported,Not Reported,,Not Reported,N,03/10/2021,03/11/2021,1.0,PVT,,,,,No,"['Death', 'Malaise']",UNK,MODERNA,IM 1094017,MD,82.0,M,"On 3/8/2021, the patient presented to the ED after mechanical fall from ground-level and developed right hip pain. The patient was diagnosed with a closed right public fracture. Per EUA, all hospitalizations must be reported after receiving a vaccine. This hospitalization does not appear to be related to the vaccine.",Not Reported,,Not Reported,Yes,2.0,Not Reported,,02/05/2021,03/08/2021,31.0,PVT,"Avodart, metoprolol tartrate, Pradaxa, Tamsulosin",,"Afib, BPH, coronary artery calcifications",,no allergies reported,"['Arthralgia', 'Fall', 'Pelvic fracture']",2,MODERNA,IM 1094021,FL,52.0,F,"Around 4pm left arm was swelling (entire) and pain. my left eye closed completely,tears and right eye barely closed. I was very sleepy was driving home.The next day I exp fatigue,diarrhea, chills and headache(right side) for the remainder of the week. I took Tylenol for headache the pain wasn't going away.I went to ER did a test for Paralysis discharged with drops for eyes. I followed up with Ophthalmology clinic they put a light to my eyes due to both being completely closed and did some test. I was told to stop using the drops from the ER because it was toxic for my eyes.Upon my discharge given instructions to due warm compress on my eyes for swelling and blurred vision. As of today I'm still ex blurred vision (both eyes) to see, hard for me to see computer,cell phone, letters.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/12/2021,01/12/2021,0.0,PUB,No,No,Celiac Disease,Flu vaccine (years ago had flu like symptoms),"Asthestimine, Antibiotics, Percocet,Flexeril","['Chills', 'Diarrhoea', 'Eye swelling', 'Eyelid function disorder', 'Fatigue', 'Headache', 'Intraocular pressure test', 'Lacrimation increased', 'Pain in extremity', 'Peripheral swelling', 'Somnolence', 'Vision blurred', 'Visual acuity tests']",1,MODERNA,IM 1094047,AZ,73.0,M,Immediate recurrence of GBS post vaccination. This time around on Tuesday pt got a COVID vaccine and 6 hours after pt started feeling nauseous and 3 days after the vaccine had numbness in his feet b/l at first. Numbness travelled upwards up to the knees. Next the weakness started extending upwards to his mid thigh. Pt will not put any weight on his legs because he knows he is very unsteady. Today he has numbness in his hands b/l. Pt had no symptoms before Tuesday. He lives at home (independent senior facility) and is coming from there. Pt woke up this morning and went from his bed to his chair and since then pt was not able to get up from the chair.,Not Reported,,Not Reported,Yes,4.0,Yes,N,02/09/2021,02/12/2021,3.0,UNK,"amLODIPine 10 mg oral tablet 10 mg = 1 tab, Oral, Daily aspirin 81 mg oral tablet 81 mg, Oral, Daily bisoprolol 5 mg oral tablet 2.5 mg = 0.5 tab, Oral, BID capsaicin 0.025% topical cream 1 app, Topical, TID DULoxetine 30 mg oral delaye","Recovering from GBS, ambulating w/ walker at home.","2020: COVID, thoracic aneurysm repair and GBS w/ prolonged weakness/ paresis.",,"Flomax, Ambien","['Anion gap', 'Balance disorder', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine normal', 'Blood glucose normal', 'Blood potassium normal', 'Blood sodium decreased', 'Blood urea nitrogen/creatinine ratio increased', 'Blood urea normal', 'Carbon dioxide normal', 'Condition aggravated', 'Dysstasia', 'Glomerular filtration rate normal', 'Guillain-Barre syndrome', 'Haematocrit decreased', 'Haemoglobin decreased', 'Hypoaesthesia', 'Immediate post-injection reaction', 'International normalised ratio normal', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Mean platelet volume normal', 'Mobility decreased', 'Muscular weakness', 'Nausea', 'Nucleated red cells', 'Platelet count normal', 'Prothrombin time normal', 'Red blood cell count decreased', 'Red cell distribution width normal', 'Weight bearing difficulty', 'White blood cell count normal']",UNK,MODERNA, 1094062,TX,27.0,F,"Janssen COVID-19 Vaccine EUA G1P0 at 33w5d by LMP, presented to L&D the evening of 3/10/2021 after experiencing fevers, chills, diaphoresis, and muscle aches beginning approximately 8 hours after vaccination. She has chronic headaches which is also present on presentation. She denies any cough, sputum production, nausea, vomiting, diarrhea, dysuria, hematuria, flank pain, abdominal pain, vaginal bleeding, rash or skin changes, no leg swelling or pain. On presentation she was noted to have a fever of almost 103F, was tachycardiac to 160s, BPs 90s/50s, and had fetal tachycardia in the 170s. Her exam was non focal with no evidence of infection. Sepsis workup was initiated which was negative. COVID-19 test was negative Discharged home in stable condition",Not Reported,,Not Reported,Yes,1.0,Not Reported,,03/10/2021,03/10/2021,0.0,PVT,"Prenatal vitamin Daily, Fish oil omega-3 capsule daily.",,,,NKDA,"['Bacterial sepsis', 'Chills', 'Condition aggravated', 'Exposure during pregnancy', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tachycardia foetal']",1,JANSSEN,IM 1094102,MS,57.0,M,"NO ADVERSE EVENT NOTICE RECEIVED ON DATE OF VACCINE. RECEIVED NOTICE FROM CORONOER THAT THIS PATIENT EXPIRED 2/28/2021. COLLECTED URINE, BLOOD, AND TOXICOLOGY SCREEN. NOT SENT TO HOSPITAL. SENT TO FUNERAL HOME",Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,02/27/2021,02/28/2021,1.0,OTH,UNKNOWN,UNKNOWN,UNKNOWN,,UNKNOWN,"['Blood test', 'Death', 'No adverse event', 'Toxicologic test', 'Urine analysis']",2,MODERNA,IM 1094110,,69.0,M,unknown. Patient is deceased,Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,,02/03/2021,02/22/2021,19.0,UNK,,,,,,['Death'],1,PFIZER\BIONTECH, 1094126,LA,47.0,M,About a week and a half after receiving the second Pfizer vaccine my husband had a stroke,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,01/01/2021,01/20/2021,19.0,PVT,No,"Diabetes, high blood pressure, high Cholesterol, 3rd stage kidney disease",Same,,Penicillin,"['Cerebrovascular accident', 'Magnetic resonance imaging']",2,PFIZER\BIONTECH,SYR 1094138,MA,82.0,M,"D= decedent D received the second dose of the COVID vaccine on 3/10/21 @ 10:45AM. His daughter, ************, transported him to the Pharmacy appointment. She notes that D did not have any complaints before or after the appointment?specifically she denies observing any weakness, dizziness, cough, and fever. D went on to have an uneventful day with normal appetite and bedtime. ************ also mentions that there were no adverse reactions following the first dose either. The next morning (3/11/21) at 6am the decedent?s wife found him in bed ?looking around the room? with gurgling agonal breathing. No seizure activity reported.",Yes,03/11/2021,Not Reported,Not Reported,,Not Reported,N,03/10/2021,03/11/2021,1.0,PHM,Metoprolol or Propranolol.,"It should also be noted that the decedent had a ?fall? 1 week ago. Unclear if witnessed or not. Ever since his stroke, he?s had right sided weakness. His mobility has declined noticeably over the last 2 months. Family was getting ready to install a stair lift and bed rails. Allegedly he ?slid out of bed? and landed on his bottom. He had a bruise on his right arm and an abrasion on his right elbow, but there was no head strike.","LENGHTY CARDIAC HISTORY: AFib (not anticoagulated, no pacemaker, last cardioversion was 1 year ago), Hemorrhagic stroke (3 years ago), myocardial infarc x 2",,none known,"['Agonal respiration', 'Cardiac flutter', 'Death', 'Endotracheal intubation', 'Hyperkalaemia', 'Laboratory test normal', 'Mental status changes', 'Pulseless electrical activity', 'Resuscitation', 'Rhythm idioventricular', 'Ventricular fibrillation', 'Ventricular tachycardia']",2,PFIZER\BIONTECH,IM 1094146,,66.0,M,"2nd dose administered on 2/20/21, on 2/23/21 the patient fell and sustained a facial injury",Yes,03/01/2021,Not Reported,Yes,,Not Reported,,01/30/2021,02/23/2021,24.0,PVT,,,,,,"['Face injury', 'Fall']",2,PFIZER\BIONTECH,IM 1094159,MO,67.0,M,"Motor paralysis of the left foot. Could not move at all.: dorsiflex, plantar flex, invert, or evert",Not Reported,,Not Reported,Yes,2.0,Yes,N,03/08/2021,03/08/2021,0.0,PVT,"Carvedilol, lisinoprol, vitamin b-12, vitamin d3, aspirin 81mg,",None,Heart disease,"17, March 1971, penicillin","Various food allergies, penicillin","['Computerised tomogram head', 'Hypokinesia', 'Magnetic resonance imaging head', 'Magnetic resonance imaging joint', 'Magnetic resonance imaging spinal', 'Peripheral paralysis', 'Peroneal nerve palsy', 'Scan with contrast']",2,MODERNA,IM 1094160,MD,72.0,F,"On 3/9/2021 the patient presented to the ED with leg weakness and was unable to walk that morning secondary to pain in her right hip. She reported falling the night prior. Upon admission, she was found to have a developing pneumonia infection. Reason for admission: possible stroke.",Not Reported,,Not Reported,Yes,4.0,Not Reported,,02/16/2021,03/09/2021,21.0,PVT,,,Dementia,,no known allergies,"['Arthralgia', 'Fall', 'Gait inability', 'Muscular weakness', 'Pneumonia']",2,MODERNA,IM 1094164,,96.0,F,deceased,Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,,01/25/2021,03/01/2021,35.0,UNK,,,,,,['Death'],1,MODERNA, 1094165,LA,74.0,F,Patient received her first dose of the Mederna Covid vaccine at the Health unit on 03/10/21. Her family states she began experiencing nausea and vomiting last night (03/11/2021) and then started having chest pain at around midnight. This morning (03/12/2021) she was still experiencing vomiting and chest pain. She collapsed at approximately 07:30 and her family initiated CPR and EMS was called. She was brought the Hospital via Ambulance at 08:18 in cardiac arrest. The emergency department was unable to resuscitate her and she was pronounced dead.,Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,03/10/2021,03/11/2021,1.0,PUB,Unknown,Unknown,Unknown,,NKA,"['Chest pain', 'Death', 'Nausea', 'Resuscitation', 'Syncope', 'Vomiting']",1,MODERNA,IM 1094187,,83.0,M,ABDOMINAL PAIN BACK PAIN death,Yes,03/05/2021,Not Reported,Yes,,Not Reported,,02/11/2021,02/21/2021,10.0,PVT,,,,,,"['Abdominal pain', 'Back pain', 'Death']",1,PFIZER\BIONTECH,IM 1094197,AL,83.0,M,"DEATH - PT'S WIFE CALLED 3-11 TO TELL US PATIENT WAS FEELING BAD, AND TO ASK WHAT TO DO. WE SENT A PULSEOXIMETER, AND ADVISED TO CONTACT DR. - ON MORNING OF 3-12, PT'S WIFE CALLED TO TELL US HE HAD PASSED AWAY DURING THE NIGHT.",Yes,03/11/2021,Not Reported,Not Reported,,Not Reported,N,02/26/2021,03/11/2021,13.0,PHM,"ELIQUIS, LASIX, PROTONIX,ALTACE, TRADJENTA, LUMIGAN, AMIODARONE, METOPROLOL",UNKNOWN,"HBP, DIABETES, MAY BE OTHERS",,UNKNOWN,"['Death', 'Feeling abnormal']",1,GLAXOSMITHKLINE BIOLOGICALS,IM 1094208,,76.0,M,ALTERED MENTAL STATUS Death,Yes,02/11/2021,Not Reported,Yes,,Not Reported,,01/26/2021,02/05/2021,10.0,PVT,,,,,,"['Death', 'Mental status changes']",1,MODERNA,IM 1094242,,85.0,M,"Fall, fever, head injury, body aches, weakness, death",Yes,02/16/2021,Not Reported,Yes,,Not Reported,,01/22/2021,01/30/2021,8.0,PVT,,,,,,"['Asthenia', 'Death', 'Fall', 'Head injury', 'Pain', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1094252,MD,72.0,M,"Patient presented to the ED on 3/8/2021 after being diagnosed with a UTI on 3/7/2021. Her reported feeling more weak and consistent fever. Reason for admission: UTI. Per EUA, all hospitalization must be reported after recently receiving a vaccine. This hospitalization does not seem related to the vaccine",Not Reported,,Not Reported,Yes,2.0,Not Reported,,02/11/2021,03/08/2021,25.0,PVT,"Albuterol HFA, Eliquis, aspirin, atorvastatin, vitamin D3, diltiazem, dorzolamide eye drops, Elderberry fruit tablets, losartan, melatonin, pantoprazole, multivitamin, Stiolto",,"Bladder cancer, afib, COPD, GERD, hypertension",,"Bactrim, lisinopril, iodinated contrast media,","['Asthenia', 'Pyrexia', 'Urinary tract infection']",2,MODERNA,IM 1094259,,65.0,M,unknown death,Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,,01/30/2021,,,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1094265,ME,51.0,M,ACUTE ST ELEVATION MYOCARDIAL INFARCTION SPONTANEOUS DISSECTION OF CORONARY ARTERY,Not Reported,,Yes,Yes,2.0,Not Reported,Y,02/23/2021,02/27/2021,4.0,PUB,ALLOPURINOL 300MG TRULICITY 1.5 MG LEVOTHYROXINE 50 MCG LISINOPRIL 10MG metFORMIN 1000MG DAILY VITAMIN VITAMIN D PROBIOTIC,,TYPE II DIABETES,,PRAVASTATIN SODIUM,"['Acute myocardial infarction', 'Coronary artery dissection', 'Laboratory test']",2,PFIZER\BIONTECH,SYR 1094285,OK,87.0,M,Had a stroke.,Not Reported,,Not Reported,Yes,2.0,Yes,N,03/10/2021,03/10/2021,0.0,OTH,,High blood pressure,,,,"['Blood test', 'Cerebrovascular accident', 'Computerised tomogram', 'Electrocardiogram']",2,MODERNA,SYR 1094287,WI,70.0,F,"chills, racing heart, pain in chest, difficulty breathing, weakness",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/28/2021,03/01/2021,1.0,PVT,promethazine,,asthma,,"adhesive, codeine, gabapentin, niacin, oxycodone with acetaminophen, nabumetone, sumatriptan Succinate, flexural, clonidine hcl, Darvon, topiramate, hydrocodone with acetaminophen","['Asthenia', 'Blood creatine', 'Chest pain', 'Chills', 'Dyspnoea', 'Metabolic function test', 'Palpitations']",1,MODERNA,IM 1094290,KY,72.0,F,Patient died on March 10th 2021 and received the vaccine on February 23 2021. Patient had health issues. Spoke with coroner and patient did die at home. Patient was taken straight the the funeral home afterwards.,Yes,03/10/2021,Not Reported,Not Reported,,Not Reported,N,02/23/2021,03/10/2021,15.0,PUB,"B12, Vitamin D, Brea Elipta 200mcg, gabapentin 800mg, Lantus, Loratadine 10mg, Metformin 1,000 mg, Metoprolol 25 mg, losartin 100 mg, Omeprazole 40 mg, Oxycodone 7.5 mg, Paroxetine 20 mg, Pioglitazone 45 mg, Rosuvastatin 40 mg, theophylline","Thyroid, Type 2 Diabetic Hyperlipidemia, Pernicious Anemia, Coronary Artery Disease, Hypertension, High cholesterol, Kidney Disease, Vascular Disease",,,,['Death'],UNK,MODERNA,SYR 1094294,MD,79.0,F,"Elevated BP, shortness of breath, tightness of the chest/chest pain, palpations, dizziness 11 days after the vaccine. Continued daily for four consecutive days onset.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,02/12/2021,02/23/2021,11.0,SCH,"Prescriptions: anastrozole, metoprolol sec, losartan, amlodipine, atorvastatin, novolog pin 7030 over the counter meds: Aleve or Tylenol when needed Dietary supplements: calcium 500mg and vitamin D3 1000IU and multivitamin no home remedie",none,"Diabetes, hypertension, sarcoidosis, high cholesterol, heart palpations, history of breast cancer, enlarged thyroid, osteopenia, sleep apnea",,Meds from Chemotherapy: Taxotere and Cytoxan,"['Blood pressure increased', 'Chest discomfort', 'Chest pain', 'Dizziness', 'Dyspnoea', 'Palpitations']",1,MODERNA,IM 1094296,KS,85.0,M,"Patient is diabetic, but well controlled with insulin. He had his second COVID vaccine on March 5. His wife noticed some increased confusion and drowsiness for the last 2 days (starting 3/9). He came to the ED on 3/11 with a blood sugar of over 600. He was admitted for observation to our unit 3/11.",Not Reported,,Not Reported,Yes,,Not Reported,N,03/05/2021,03/09/2021,4.0,PVT,"Amlodipine, Aspirin, Atenolol, Cyanocobalamin, Humalog, Insulin NPH, Levothyroxine, Lisinopril, Multivitamin, Simvastatin, Zinc",None,"Diabetes, Hypertension, hyperlipidemia, hypothyroidism",,"Metaxalone, Codeine","['Blood glucose increased', 'Blood lactic acid', 'Confusional state', 'Somnolence']",2,MODERNA,IM 1094300,,61.0,F,death,Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,,02/05/2021,02/24/2021,19.0,PVT,,,,,,['Death'],UNK,MODERNA, 1094322,,66.0,M,"2nd dose given on 2/24/2021, deceased on 3/2/2021",Yes,03/02/2021,Not Reported,Not Reported,,Not Reported,,02/03/2021,03/02/2021,27.0,PVT,,,,,,['Death'],2,PFIZER\BIONTECH,IM 1094332,CA,82.0,F,"Vaccine recd 1/20 and 9 days after I got really sick and still having breathing trouble and short of breath, now using breathing treatments, I'm having a hard time walking, weakness all over, headaches, and I feel so out of it.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/20/2021,01/30/2021,10.0,SEN,"Fish Oil, C, D3, Calcium, Tylenol, Miraprex,",no,no,,no,"['Arthrogram', 'Asthenia', 'Dyspnoea', 'Feeling abnormal', 'Gait disturbance', 'Headache', 'Laboratory test', 'Magnetic resonance imaging head', 'Malaise', 'Scan with contrast']",1,PFIZER\BIONTECH,IM 1094343,,89.0,F,ABDOMINAL PAIN death,Yes,02/17/2021,Not Reported,Yes,,Not Reported,,01/28/2021,02/17/2021,20.0,PVT,,,,,,"['Abdominal pain', 'Death']",1,PFIZER\BIONTECH,IM 1094363,MD,75.0,F,"Patient presented to the ED on 3/9/2021 with chest pain, headache, and brief blurred vision. There was no signs of stroke or MI event. Reason for admission: chest pain.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,03/04/2021,03/09/2021,5.0,PVT,"Alka-Seltzer PM, vitamin B12, dandelion root, Voltaren gel, Benadryl, famotidine, loratadine, magnesium, multivitamin, propranolol, vitamin B6, Florastor, immune support complex",,"GERD, anxiety, diabetes, hypertension",,"ACE inhibitors, ranitidine","['Chest pain', 'Headache', 'Vision blurred']",2,MODERNA,IM 1094389,,81.0,F,Patient coded in the hospital and went into PEA,Not Reported,,Not Reported,Yes,,Not Reported,N,03/11/2021,03/11/2021,0.0,PVT,,,,,,"['Cardio-respiratory arrest', 'Pulseless electrical activity']",UNK,PFIZER\BIONTECH, 1094402,,81.0,M,death,Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,,02/02/2021,03/01/2021,27.0,PVT,,,,,,['Death'],1,MODERNA,IM 1094413,MD,78.0,F,Patient presented to the ED on 3/9/2021 with symptomatic anemia. The patient has a history of this. The patient received PRBC and platelets.,Not Reported,,Not Reported,Yes,2.0,Not Reported,,02/26/2021,03/09/2021,11.0,PVT,"acetaminophen, cetirizine, vitamin D3, Flonase, metformin, metoprolol succinate, multivitamin, omeprazole, Visine dry eye drops, potassium chloride, pravastatin, tramadol",,"Myelomonocytic leukemia, chronic anemia and thrombocytopenia, HTN, hyperlipidemia, CAD post CABG, rheumatoid, arthritis, Type 2 DM, PUD",,NKA,"['Anaemia', 'Packed red blood cell transfusion', 'Platelet transfusion']",1,PFIZER\BIONTECH, 1094421,,86.0,F,cardiac arrest death,Yes,02/09/2021,Not Reported,Yes,,Not Reported,,01/28/2021,02/09/2021,12.0,PVT,,,,,,['Cardiac death'],1,PFIZER\BIONTECH,IM 1094441,,87.0,M,death,Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,,01/07/2021,02/10/2021,34.0,UNK,,,,,,['Death'],1,PFIZER\BIONTECH, 1094457,PA,79.0,F,"Was napping the day after receiving the vaccine and woke up about 3:00 pm to severe chest pain on the right side radiating deep into the shoulder blade. It would last about 5 - 10 min., stop for the same amount of time, then start up again.... on & off until close to 11:00 pm. Since someone else I know had the same thing happen the day after her shot, I assumed I had the same symptom, tho' it was very frightening. A week later after going to bed on Friday night, I woke at 2:00 a.m. to the same pain only this time on my left side. Thinking I could be having a heart attack, I went to the hospital where I was admitted after having a series of tests. I was there for 2 days during which time I also began to have un-controllable diarrhea. Altho' they could find nothing wrong with my heart, after scans, x-rays, a stress test, numerous blood tests etc., they cannot say positively whether or not it was from the Covid vaccine. I tho't it best to report this in case others have similar events. I had the MODERNA vaccine",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/24/2021,02/25/2021,1.0,SCH,"Atenalol 50 mg 3 x daily, Levothyroxine 88 mcg 1 x daily, Hydrochlorothiazide 12.5 mg 1 x daily, simvastatin 10mg 1 x daily, Omeprazole 20 mg 1 x daily, 1 Baby aspirin daily.",None,"High BP, underactive thyroid",,"Sulfur drugs, cortizone","['Arthralgia', 'Blood test', 'Cardiac stress test', 'Chest pain', 'Diarrhoea', 'Pain', 'Scan', 'X-ray']",1,MODERNA, 1094468,ME,84.0,M,Hospitalization after a fall resulting in femoral neck fracture. Patient deceased 3/4/21.,Yes,03/04/2021,Not Reported,Yes,,Not Reported,N,02/11/2021,03/04/2021,21.0,OTH,,,,,,"['Death', 'Fall', 'Femoral neck fracture']",1,MODERNA,IM 1094488,IL,46.0,F,"patient administered vaccine at another facility and presented to this facilities ED on 2/24. Patient with multiple comorbidities: Bipolar disorder, parkinsons, PD, COPD, DM, PVD, GERD, HTN, Dyslipidemia, sleep apnea. H/O CVA, has sacral decubitus and cellulitis of pannus. presents with sepsis likely secondary to cellulitis of pannus. Admitted for care then discharged on 2/26",Not Reported,,Not Reported,Yes,2.0,Not Reported,,02/19/2021,02/24/2021,5.0,UNK,,sacral decubitus,"Bipolar disorder, Parkinsons, PD, COPD, DM, PVD, GERD, HTN, Dyslipidemia, H/O CVA, H/O sleep apnea, Positive for Covid 19 on 12/23",,"amoxicillin, codeine, iv dye, albuterol","['Panniculitis', 'Sepsis']",UNK,PFIZER\BIONTECH, 1094490,OK,66.0,F,"Patient was vaccinated with her second dose on Wednesday, February 24th. A family member contacted us to let us know she was sitting in a casino exactly one week later and passed out, going into cardiac arrest. The patient did pass away.",Yes,03/10/2021,Not Reported,Not Reported,,Not Reported,N,02/24/2021,03/10/2021,14.0,PHM,unknown,,"Heart disease, high blood pressure",,unknown,"['Cardiac arrest', 'Death', 'Loss of consciousness']",2,PFIZER\BIONTECH,IM 1094496,GA,67.0,F,"Severe hyponatremia, seizure, vomiting. Required hospitalization, 3% hypertonic saline, consultation with neurology and nephrology. Initial sodium level 114 at discharge sodium was 136. She recovered and is well now.",Not Reported,,Yes,Yes,4.0,Not Reported,Y,03/03/2021,03/05/2021,2.0,PVT,"Aspirin, Vit. B-12, Multivitamin, Vit. D3, L-Lysine, Magnesium, Niacin, Omega-3 Fatty Acids, Patriot Power Greens, Phosphatidyl Serine, Turmeric, Probiotic, Vit B-1, Vit. C, inc",None,"Osteoporosis, Hyperlipidemia, Subclinical Carotid Atherosclerosis",,NKDA,"['Blood sodium decreased', 'Blood sodium normal', 'Hyponatraemia', 'Seizure', 'Vomiting']",2,MODERNA,IM 1094503,AK,72.0,M,"Four days after receiving the Moderna second dose, I had a pulmonary embolism of my right lung. It was diagnosed only on Feb. 19, as I was totally unfamiliar with the symptoms and had another indication of a problem: tachycardia, so went to the clinic. I am not sure this isn't coincidental, but I have no history of embolisms, and no family history. No one at the time of my diagnosis asked when I gotten vaccine. As I said , this may be entirely coincidental, or it may not. I am presently on eliquis blood thinners, and have had no further problems.",Not Reported,,Yes,Not Reported,,Not Reported,Y,02/10/2021,02/14/2021,4.0,PVT,"Vitamins, no other medications",Just arthritic hips and knee.,Arthritis,,No known,"['Blood test', 'Computerised tomogram', 'Pulmonary embolism', 'Tachycardia', 'X-ray']",UNK,MODERNA, 1094506,GA,81.0,F,Patient is a 81 y.o. female who received the Moderna vaccine on Monday. On Tuesday she developed oral purpura and began spitting up blood. She developed some large hematomas. She was seen in clinic today and had a platelet count of 5k previously normal. Labs are still pending right now. No head ache or neuro changes. No obvious GI bleeding. No chest pain or shortness of breath.,Not Reported,,Not Reported,Yes,3.0,Not Reported,N,03/08/2021,03/10/2021,2.0,PVT,,,,,,"['Haematoma', 'Haemoptysis', 'Oral purpura', 'Platelet count decreased']",1,MODERNA,IM 1094509,IL,83.0,M,Chief Complaint Patient presents with ? Rash � � C/o rash to extremities and buttock that started about 3 days ago. ? Edema � � C/o edema to lower extremities and abdomen. ? Shortness of Breath � � Having shortness of breath on exertion. Had to stop and take a break twice on the way to the office from the lobby. � � Subjective: HPI Patient is 83 y.o. year old male that presents for acute problem as noted above. Received call from patient late yesterday evening complaining of petechial rash to extremities. States they originally were pruritic. Now states they no longer itch. Patient states that the rash started about 3 days ago. His main lower extremities and buttocks. Also complained of increased edema to lower extremities. Also feels like his abdomen is swollen. Patient was treated for diverticular flare middle of February. Has completed antibiotic specifically Augmentin about 2 weeks ago. Patient having increased shortness of breath. States he does have a productive cough in the morning producing yellow sputum. Afebrile. Patient does have history of atrial fib. Has had no nausea vomiting but states any time he eats he can only eat a small amount then feels full. Patient is on Coumadin chronically. Recent INR has been within normal limits. Patient does have some tenderness to his abdomen more so to the upper quadrants. Denies any change in bowel habits. States he is mildly constipated. Denies any change in color stool. Denies any actual chest pain. Does get remarkably short of breath. � Review of Systems A 10 point ROS was completed and negative except as noted in HPI 3/12 Presented to Emergency Room - admitted inpatient @ 1144,Not Reported,,Not Reported,Yes,,Not Reported,N,02/22/2021,03/08/2021,14.0,PVT,coumadin,,,,Lisinopril,"['Abdominal distension', 'Abdominal hernia', 'Abdominal tenderness', 'Alanine aminotransferase normal', 'Aortic arteriosclerosis', 'Ascites', 'Aspartate aminotransferase normal', 'Atelectasis', 'Blood alkaline phosphatase normal', 'Blood bilirubin increased', 'Blood calcium normal', 'Blood chloride normal', 'Blood creatinine increased', 'Blood glucose normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea increased', 'Brain natriuretic peptide increased', 'Carbon dioxide increased', 'Chest X-ray abnormal', 'Computerised tomogram', 'Computerised tomogram abdomen', 'Constipation', 'Dyspnoea', 'Electrocardiogram', 'Full blood count', 'Generalised oedema', 'Haematocrit normal', 'Haemoglobin normal', 'Hypophagia', 'International normalised ratio increased', 'Interstitial lung disease', 'Localised oedema', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Oedema peripheral', 'Petechiae', 'Platelet count normal', 'Pleural effusion', 'Productive cough', 'Protein total normal', 'Prothrombin time prolonged', 'Rash', 'Rash pruritic', 'Red blood cell sedimentation rate increased', 'Sputum discoloured', 'Tenderness', 'White blood cell count normal']",2,MODERNA,IM 1094512,IL,96.0,F,Emesis 3/4/2021 03/05/2021 Pneumonia,Yes,03/07/2021,Not Reported,Yes,1.0,Not Reported,N,02/25/2021,03/04/2021,7.0,SEN,Type Description Last administered PRN reason Prescription acetaminophen [OTC] capsule; 325 mg; amt: 2 tablets; oral Prescription amlodipine tablet; 5 mg; amt: 1 tab; oral Spec. Inst: Hold if SBP < 120 Prescription Artificial Te,UTI 01/01/2021,"ICD-10 Illness J18.9 Pneumonia, unspecified organism (Primary) I21.4 Non-ST elevation (NSTEMI) myocardial infarction (Admission) F95.9 Tic disorder, unspecified Z45.2 Encounter for adjustment and management of vascular access device Note: IV's R94.5 Abnormal results of liver function studies K56.0 Paralytic ileus Note: minimal adynamic ileus R26.81 Unsteadiness on feet S06.5X0S Traumatic subdural hemorrhage without loss of consciousness, sequela Note: chronic Z87.440 Personal history of urinary (tract) infections I67.82 Cerebral ischemia Note: age related R25.8 Other abnormal involuntary movements Note: ""head bobbing/mvmnts"" G25.2 Other specified forms of tremor Note: mild in hands F41.9 Anxiety disorder, unspecified R53.81 Other malaise Note: deconditioning R45.1 Restlessness and agitation E87.5 Hyperkalemia R55 Syncope and collapse R41.82 Altered mental status, unspecified R13.12 Dysphagia, oropharyngeal phase J98.11 Atelectasis Note: chronic scarring/atelectasis K30 Functional dyspepsia R41.841 Cognitive communication deficit Z95.0 Presence of cardiac pacemaker G30.9 Alzheimer's disease, unspecified I63.9 Cerebral infarction, unspecified Note: chronic -R pariet/occip region E78.5 Hyperlipidemia, unspecified I10 Essential (primary) hypertension I73.9 Peripheral vascular disease, unspecified E11.9 Type 2 diabetes mellitus without complications E03.9 Hypothyroidism, unspecified M19.90 Unspecified osteoarthritis, unspecified site Z95.810 Presence of automatic (implantable) cardiac defibrillator Z79.82 Long term (current) use of aspirin K59.00 Constipation, unspecified F03.90 Unspecified dementia without behavioral disturbance Z98.41 Cataract extraction status, right eye Z98.42 Cataract extraction status, left eye R29.6 Repeated falls Z91.81 History of falling Note: 06/22/2020 R56.9 Unspecified convulsions (History of) D64.9 Anemia, unspecified R53.1 Weakness",,NKA,"['Pneumonia', 'Vomiting']",2,PFIZER\BIONTECH,IM 1094566,WA,75.0,M,"abrupt onset dysarthria, left facial droop and left hemiparesis on 03/10/2020 (2 days after vaccine admin) concerning for ischemic stroke. Found to have right ICA and M1 occlusions on imaging suggestive of large vessel occlusion as etiology of stroke.",Not Reported,,Yes,Yes,2.0,Yes,,03/08/2021,03/10/2021,2.0,PVT,,,Glaucoma Possible atrial fibrillation,,sulfas penicillin,"['Brain scan abnormal', 'Cerebral artery occlusion', 'Cerebrovascular accident', 'Dysarthria', 'Facial paralysis', 'Hemiparesis']",2,PFIZER\BIONTECH,SYR 1094595,VA,32.0,M,Developed appendicitis that led to appendectomy,Not Reported,,Yes,Yes,1.0,Yes,Y,01/19/2021,03/05/2021,45.0,MIL,None,None,None,,None,"['Appendicectomy', 'Appendicitis']",2,PFIZER\BIONTECH,IM 1094600,TX,72.0,M,It is unknown if the decedent had any side effects. Patient died on 3/11/2021.,Yes,,Not Reported,Not Reported,,Not Reported,,02/06/2021,02/06/2021,0.0,UNK,,,,,,['Death'],2,MODERNA,UN 1094603,MD,94.0,F,"On 3/10/2021 the patient presented to the ED with fatigue and diarrhea. The patient had been constipated and then started taking magnesium citrate and Colace. Since starting the laxatives the patient had been experiencing diarrhea. Once at the hospital, the patient was routinely tested for COVID-19. She had one COVID antigen that was positive and one negative, and the COVID PCR negative. Chest xray shows no pneumonia and he WBC was 11,000. Reason for admission: diarrhea and weakness.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/17/2021,03/10/2021,21.0,PVT,"Caltrate+D, docusate, Boniva, magnesium citrate, metoprolol tartrate, multivitamin, Nucynta, Miralax, Xarelto, rosuvastatin, Synthroid,",,"Hyperlipidemia, HTN, Afib, hypothyroidism",,"Codeine, diphenhydramine, azithromycin, loratadine, prednisone","['Chest X-ray normal', 'Constipation', 'Diarrhoea', 'Fatigue', 'SARS-CoV-2 test negative', 'SARS-CoV-2 test positive', 'White blood cell count increased']",2,MODERNA,IM 1094634,NY,79.0,M,Patient developed worsening edema and shortness of breath. Became fatigued and went to Emergency Department. He was admitted for 3 days with CHF atrial fib.,Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/17/2021,02/21/2021,4.0,OTH,"Plavix, ASA, Atorvastin, Flomax, Lisinopril, D3, Glipizide,",S/P NSEMI,"CAD, HTN, Type II DM, BPH",,None Known,"['Atrial fibrillation', 'Cardiac failure congestive', 'Dyspnoea', 'Fatigue', 'Oedema']",2,MODERNA,IM 1094638,PA,74.0,M,"Exposure to Covid 19 either on the date of vaccine (2/13/21) or shortly thereafter. Symptoms of Covid started on Monday (2/15) early morning following shot. Dr. ordered Covid test on Weds. (2/17). Taken by ambulance to Hospital, approx. 7 pm on Saturday (2/20) with dehydration, low oxygen levels, confusion, shaking and cough. Admitted to hospital with threats of ventilator up until Weds (2/24) when he was intubated, proned and FINALLY given hydration via IV fluids. He went into kidney failure on Thursday (2/25) and put on dialysis. Other organs began shutting down and was taken off the ventilator on Friday (2/26) and did not recover. He passed away just before 4:00 p.m. on 2/26/21.",Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/15/2021,2.0,MIL,"Jardiance, Metformin, Buproprian, Symbacort, Blood Pressure Medicine, Staten Medication, Zinc, Vitamin C, Vitamin D, Quercetin, Low Dose Baby Aspirin, Melatonin, Performa mist and Albuteral","Ongoing effects of Agent Orange exposure, Asthma, Diabetes Type 2 and High Blood Pressure","Diabetic, Severe Asthma, Chronic Cough",,Augmentin and Penicillin,"['COVID-19', 'Confusional state', 'Cough', 'Death', 'Dehydration', 'Dialysis', 'Endotracheal intubation', 'Exposure to SARS-CoV-2', 'Mechanical ventilation', 'Multiple organ dysfunction syndrome', 'Oxygen saturation decreased', 'Renal failure', 'SARS-CoV-2 test positive', 'Tremor']",1,MODERNA,IM 1094688,GA,71.0,F,"Afib episode; rapid heart beat; pain in jaw; diarrhea; headache; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number El266) via an unspecified route of administration in the left arm on 05Mar2021 at 09:00 (at the age of 71-year-old) at single dose for COVID-19 immunisation. Relevant medical history included atrial fibrillation, asthma, chronic obstructive pulmonary disease, high cholesterol, acid reflux disease, depression and anxiety. Concomitant medications included clonazepam, apixaban (ELIQUIS), fluoxetine, metoprolol and simvastatin. On 07Mar2021 at 14:00, the patient experienced Afib episode, rapid heart beat, pain in jaw, diarrhea, headache, nausea and dizziness; the events Afib episode and rapid heart beat were considered serious as life-threatening. The patient received corrective treatment for the reported events, which included 2 tablets of metoprolol. The patient did not have COVID-19 prior to vaccination, and she was not tested for COVID-19 post vaccination. The patient recovered from the events on an unspecified date. No follow-up attempts are possible. No further information is expected.",Not Reported,,Yes,Not Reported,,Not Reported,Y,03/05/2021,03/07/2021,2.0,UNK,CLONAZEPAM; ELIQUIS; FLUOXETINE; METOPROLOL; SIMVASTATIN,,Medical History/Concurrent Conditions: Acid reflux (esophageal); AFib; Anxiety; Asthma; COPD; Depression; High cholesterol,,,"['Atrial fibrillation', 'Diarrhoea', 'Dizziness', 'Headache', 'Heart rate', 'Heart rate increased', 'Nausea', 'Pain in jaw']",1,PFIZER\BIONTECH, 1094694,CA,90.0,M,pneumonitis,Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/18/2021,02/20/2021,2.0,OTH,"magnesium selenium Vit A, C,E Zinc Lysine Co-Q 10",,COPD HTN hx Non-hodgkin's Lymphoma MVR CKD GERD,,,"['Chest X-ray', 'Pneumonitis', 'White blood cell count increased']",UNK,MODERNA,IM 1094699,IL,96.0,F,"96yo female who received her vaccine at her NH on 1/25/2021 presented to this reporters facility ED on 02/22/2021. Patient has a PMH of Afib, HTN, s/p CABG, and h/o CVA in 2018. brought in by NH staff with ""stoke like Symptoms"" Comfort care requested. DC to NH on Hospice Care",Not Reported,,Yes,Not Reported,,Not Reported,,01/25/2021,02/22/2021,28.0,UNK,,,,,NKDA,['Neurological symptom'],1,PFIZER\BIONTECH, 1094702,MD,66.0,M,"On 3/10/2021 the patient presented to the ED with chest pain and fatigue. The patient was found to be hyponatremic. His sodium was repleted and his BP medications were adjusted. Per EUA, hospitalizations must be reported due to recent vaccine administration. This hospitalization appears not to be related to the vaccine.",Not Reported,,Not Reported,Yes,3.0,Not Reported,,03/02/2021,03/10/2021,8.0,PVT,"Metoprolol tartrate, lansoprazole, vitamin D3, amlodipine, lisinopril/HCTZ",,"arthritis, GERD, COPD, prostate cancer, afib, HTN",,"celecoxib, moxifloxacin","['Blood sodium decreased', 'Chest pain', 'Fatigue', 'Hyponatraemia']",1,PFIZER\BIONTECH,IM 1094719,MI,71.0,F,Patient reported as deceased 3 days after vaccination by son.,Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/22/2021,3.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1094734,IL,80.0,F,"Received vaccine at local health department clinic on 02/18/2021-presents to this reporters facility ED on 02/23 with worsening shortness of breath x 24 hours. patient currently off warfarin for afib x 72 hours due to upcoming outpatient scheduled carpal tunnel surgery 2/25. afib with RVR in ED. Afib treated in ED, anticoagulation therapy resumed, surgery delayed",Not Reported,,Not Reported,Yes,2.0,Not Reported,,02/18/2021,02/23/2021,5.0,UNK,,,"afib, HTN, Hyperlipidemia, DM, GERD",,"amoxicillin, sulfa, clindamycin","['Atrial fibrillation', 'Dyspnoea']",1,PFIZER\BIONTECH, 1094739,MD,70.0,M,"On 3/10/2021 the patient presented to the ED with dizziness with palpitations. Upon admission, it was found that the patient has an aneurysm in the ascending aorta. Reason for admission: dizziness and palpitations.",Not Reported,,Not Reported,Yes,2.0,Not Reported,,02/05/2021,03/10/2021,33.0,PVT,"Multivitamin, Vitamin B6, losartan, famotidine, Coenzyme Q10, atorvastatin, aspirin",,"Hyperlipidemia, HTN",,no known allergies,"['Aortic aneurysm', 'Dizziness', 'Palpitations']",2,MODERNA,IM 1094774,MD,84.0,M,On 3/11/2021 the patient presented to the ED with worsening afib and SOB for 4 days prior. He also reported neck and shoulder pain. His afib medications were adjusted and the symptoms resolved.,Not Reported,,Not Reported,Yes,2.0,Not Reported,,03/08/2021,03/11/2021,3.0,PVT,"Vitamin C, aspirin, atorvastatin, Xalatan, lisinopril",,"Afib, HTN",,no known allergies,"['Arthralgia', 'Atrial fibrillation', 'Condition aggravated', 'Dyspnoea', 'Neck pain']",2,PFIZER\BIONTECH,IM 1094775,NY,46.0,M,"Patient went to Emergency Room d/t UTI, C-diff colitis, PE/DVT admitted treated with IV heparin, Vancomycin/flagyl, antibiotics for UTI",Not Reported,,Not Reported,Yes,7.0,Not Reported,Y,02/23/2021,02/27/2021,4.0,OTH,"Synthroid, Crestor, Vacepa, Lyrica, Wellbutrin, Hydrocodone, Depo-Provera, Ambien, Flexeril, Methotrexate",,"DJD lumbar,RA, Depression, Type II DM, HTN, Obesity, Hypothroidism",,ASA,"['Clostridium difficile colitis', 'Computerised tomogram thorax', 'Culture urine', 'Deep vein thrombosis', 'Intervertebral disc degeneration', 'Pulmonary embolism', 'Scan with contrast', 'Ultrasound scan', 'Urinary tract infection']",1,MODERNA,IM 1094784,NE,70.0,M,Approx 7 minutes after vaccine administration patient complained of lightheadedness and became diaphoretic Due to recent foot surgery patient was in wheelchair and chair was tipped back. Patient stated decreased lightheadedness. 911 called and patient transported to ER,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/05/2021,03/05/2021,0.0,PVT,Unknown,"2/17 Patient had left foot 1st MTPJ arthrodesis, excision soft tissue mass, 1st MTPJ capsuar reconstruction and calcaneal osteotomy . Taking narcotic pain medication. History hypertension patient states he takes 3 antihypertensive meds and had taken them the morning of 3/5. Patient states he did not eat much for breakfast.",Hypertension,,No known medication allergies,"['Dizziness', 'Hyperhidrosis', 'Hypotension', 'Wheelchair user']",2,MODERNA,IM 1094785,GA,79.0,M,"Admitted with complete heart block; vaccine lot number, etc unknown Just received 2nd dose 3/10/21",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,03/10/2021,03/12/2021,2.0,PVT,"Sinemet, ASA, Plavix, amantadine, lipitor","CAD, HTN, hyperlipidemia, parkinsons",Same,,"PCN, prochlorperazine","['Atrioventricular block complete', 'Electrocardiogram abnormal']",UNK,PFIZER\BIONTECH, 1094791,CA,81.0,M,"81 year old male with h/o M. Abscessus infection, glaucoma, HTN, HLD, BPH, TIA,�who presents with 3-4 days of severe weakness and SOB found to have new bilateral upper lobe ground glass infiltrates;RPP negative, �BAL gram stain negative . Per outpatient note: Started imipenem/cilastatin and tigecycline on 10/10/20 and on Arikayce and clofazimine 10/23/20. He was transitioned to omdacycline/clofazamine/arikayce 12/20/2020. Initially on the floor but now txf'ed to ICU for worsening respiratory distress. Relevant labs: His smears and cx have been negative since 11/23/2020 including�12/10/20, 12/11/20��2/8/2021. He was found to have new bilateral UL ground glass changes by CTA and underwent BAL 3/10 for possible atypical infection versus drug induced pneumonitis; covid 19 neg PCR What was used to treat this reaction? Held Arikayce. Gave Solumedrol. Unsure if his pneumonitis was caused by Arikayce or the Covid vaccine. ADR Prior to admission? Yes Severity: Severe Probability: Possible ADR Preventable: not preventable �",Not Reported,,Not Reported,Yes,,Not Reported,N,02/24/2021,03/01/2021,5.0,PVT,Arikayce nebulizer Clofazimine omadacycline amlodipine benzonatate Combivent mirtazapine tamsulosin atorvastatin clopidogrel,,"Mycobacterium Abscessus infection (on tx), glaucoma, HTN, HLD, TIA",,"NSAIDs, codeine, erythromycin, Norco","['Angiogram pulmonary abnormal', 'Asthenia', 'Bronchoalveolar lavage normal', 'Dyspnoea', 'Gram stain negative', 'Intensive care', 'Lung infiltration', 'Lung opacity', 'Respiratory distress', 'Respiratory viral panel', 'SARS-CoV-2 test negative', 'Treponema test negative']",1,MODERNA,IM 1094799,,74.0,F,Hospitalization starting 3/9/21,Not Reported,,Not Reported,Yes,,Not Reported,U,02/25/2021,03/09/2021,12.0,UNK,,,,,,['Unevaluable event'],1,MODERNA,IM 1094810,GA,80.0,M,Patient had sudden cardiac arrest; currently on a ventilator with very poor prognosis 3/11/21; 1st COVID vaccine given 3/2/21,Not Reported,,Yes,Yes,3.0,Not Reported,N,03/02/2021,03/11/2021,9.0,PVT,"Flecainide, Lopressor, Eliquis, ditropan","afib, CAD, HTN, Hyperlipidemia, Type II diabetes",Same,,ciprofloxacin,"['Cardiac arrest', 'General physical health deterioration', 'Mechanical ventilation']",UNK,PFIZER\BIONTECH, 1094826,OH,38.0,F,Patient heart was visibly beating in her chest and she was clammy. Went to Hospital and was admitted to run tests. Patient does have family history of early onset heart disease.,Not Reported,,Not Reported,Yes,,Not Reported,U,03/08/2021,03/11/2021,3.0,PHM,"JUNEL FE 1/20, METFORMIN, CRESTOR",COVID,TYPE II DIABETIC,,NONE,"['Cold sweat', 'Palpitations']",1,MODERNA,IM 1094834,FL,66.0,F,"Patient admitted to hospital with fever, shortness of breath.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/10/2021,03/10/2021,0.0,PVT,"furosemide 40 mg, lisinopril 40mg, amlodipine 5mg. gabapentin 100mg,isulin, diclofenac sul 1%, paroxetine 20mg, and trazodone 50mg",In February she call complaining of dizziness and head aches.,,,penicillin,"['Dyspnoea', 'Pyrexia']",1,JANSSEN,IM 1094836,MD,86.0,F,The patient presented to the ED on 3/10/2021 after falling. She reported lower back pain and left-sided abdominal pain. It was found that she has a closed wedge compression fracture of fourth thoracic vertebra.,Not Reported,,Not Reported,Yes,3.0,Not Reported,,01/21/2021,03/10/2021,48.0,PVT,unknown,unknown,"anxiety, breast cancer, GERD, glaucoma, Gout, HTN, IBS, insomnia, osteoporosis, plantar fasciitis, sciatica",,Levofloxacin,"['Abdominal pain', 'Back pain', 'Fall', 'Spinal compression fracture', 'Thoracic vertebral fracture']",2,PFIZER\BIONTECH,IM 1094838,,70.0,M,"Presented to the ED with rigors, rash vomiting, and diarrhea. He was found to be mildly hypotensive in the ED. He also had a WBC count of 20500 and a diffuse maculopapular rash. He was admitted for probable COVID vaccine allergy.",Not Reported,,Not Reported,Yes,1.0,Not Reported,,03/09/2021,03/10/2021,1.0,UNK,,,,,,"['Chills', 'Diarrhoea', 'Hypotension', 'Rash', 'Rash maculo-papular', 'Vomiting', 'White blood cell count increased']",UNK,MODERNA, 1094847,MA,62.0,M,"Patient was seen at Facility 10 minutes after his Pfizer immunization. He had wooziness, and hyperventilation with a breathing rate of 40. He was transferred by wheelchair to a stretcher. Initial Vitals: BP 128/68, O2 sat 96% on 2 liters O2, pulse 68; veteran was diaphoretic, with clear lungs. He did not recall he had an immunization, and was uncertain of his own age. He did report he was on metformin for DMII. 911 was called. He was transported to Hospital ER by EMTs.",Not Reported,,Yes,Yes,4.0,Not Reported,Y,03/09/2021,03/09/2021,0.0,PVT,APIXABAN 5MG TAB TAKE ONE TABLET BY MOUTH TWICE DAILY ACTIVE ASPIRIN 81MG EC TAB TAKE ONE TABLET BY MOUTH ONCE ACTIVE DAILY TO PREVENT STROKE/HEART ATTACK ATORVASTATIN CALCIUM 80MG TAB TAKE ONE TABLET BY ACTIVE,"COPD,HTN","1. Sleep Apnea (SCT 73430006) 2. Cardiac pacemaker in situ 12/05/2019 CDH, DR. 3. Atrial Flutter (SCT 5370000) Cryoablation Aug/2020 4. Acute non-ST segment elevation myocardial infarction with 2 DES. 5. Bipolar disorder in remission Reviewed 6. Other Specified Housing or Economic Circumstances 7. Unemployed (SNOMED CT 73438004) 8. Cluster headache (SNOMED CT 193031009) 9. Benign essential hypertension (SNOMED CT 1201005) 10. Syncope and collapse 11. Gastritis H. pylori Positive MAR 10 - Rx Eradicatioon Therapy 12. 413-209-8580 13. FAM HX-ISCHEM HEART DIS CAD 14. Carpal Tunnel Syndrome * 15. Heart Murmurs * 16. Nicotine dependence with current use (SNOMED CT 724698009) Reviewed 17. Insomnia 18. Hyperlipidemia and metabolic syndrome 19. Allergic rhinitis * 20. Obesity * 21. Arthritis/DJD 22. Cocaine dependence, in remission",,Bee stings-urticaria/PCN-rash,"['Confusional state', 'Dizziness', 'Hyperhidrosis', 'Hyperventilation', 'Memory impairment']",1,PFIZER\BIONTECH,IM 1094855,GA,90.0,M,Patient developed ITP after receiving the covid-19 vaccination. He was admitted at the outside hospital in January 2021 and was found with a platelet level of 79. He presented in this admission at hospital his platelets dropped to 30.,Not Reported,,Not Reported,Yes,,Not Reported,N,01/12/2021,03/02/2021,49.0,OTH,,,"CHF, COPD, CAD, DM, HTN",,nka,"['Immune thrombocytopenia', 'Platelet count decreased']",UNK,MODERNA, 1094868,,89.0,M,"Started having confusion at 3#0 a.m. Sunday morning. Unstable gait and hypoxia at home. More congested than usual. Had 2nd COVID vaccine 4 weeks ago. Had visual hallucinations with seeing ""bugs"" Admitted with positive COVID and Influenza B diagnosis.",Yes,03/12/2021,Not Reported,Yes,4.0,Not Reported,,02/01/2021,03/07/2021,34.0,UNK,,,,,,"['COVID-19', 'Confusional state', 'Gait disturbance', 'Hallucination, visual', 'Hypoxia', 'Influenza', 'Influenza B virus test positive', 'Respiratory tract congestion', 'SARS-CoV-2 test positive']",2,MODERNA, 1094874,MD,77.0,F,On 3/11/2021 the patient presented to the ED for rectal bleeding after a bowel movement and rectal pain. The patient had apparent external hemorrhoids. The patient denied diarrhea.,Not Reported,,Not Reported,Yes,2.0,Not Reported,,02/24/2021,03/11/2021,15.0,PVT,"Eliquis, fluoxetine, iron/vitamin C, lisinopril, mesalamine, metformin, potassium chloride",unknown,"colon cancer, recurrent DVT, IBS",,Iodine,"['Haemorrhoids', 'Proctalgia', 'Rectal haemorrhage']",1,PFIZER\BIONTECH,IM 1094882,IL,59.0,F,"3/6/21 ER 59 y.o. female who presents with SHORTNESSS OF BREATH FROM NURSING HOME. EMS STATES THAT PT HAD COPIOUS ORAL SECRETIONS AND WAS IN REESPIRATORY DISTRESS UPON THEIR ARRIVAL.EMS PRE-ARRIVAL TREATMENT: IV ATTEMPTS UNSUCCESSFUL, PLACED ON BIPAP AND SATS CAME UP TO 98% Presented by EMS from facility with altered mental status confusion Desat 85 on 02 3L NC foaming at the mouth is What nursing home staff reported; EMS unable to get IV access but did apply CPAP at 10 with sat of 99%; patient will wake up with painful stimuli. � � Nursing Home reports patient wears BIPAP S.T. rate 20/8/10 at night and 2 hours during the Day COVID vaccination Pfizer patient received 1/7/2021 and 1/28/2021 Took insulins this morning and guaifenesin, blood sugar accu check 221 Transferred to higher level of care",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,01/28/2021,03/06/2021,37.0,SEN,"Current Outpatient Medications: ? acetaminophen (TYLENOL) 500 MG tablet, Take 500 mg by mouth every 6 hours as needed for Pain or Fever Max 3000 mg/24 hours , Disp: , Rfl: ? aspirin 81 MG EC tablet, Take 81 mg by mouth daily, Disp: , Rf",,,,nka,"['Bilevel positive airway pressure', 'Blood creatinine increased', 'Blood urea increased', 'Cardiomegaly', 'Chest X-ray abnormal', 'Confusional state', 'Continuous positive airway pressure', 'Dyspnoea', 'Electrocardiogram normal', 'Foaming at mouth', 'Laboratory test', 'Lung opacity', 'Pneumonia', 'Pulmonary oedema', 'Renal function test', 'Respiratory distress', 'Salivary hypersecretion']",2,PFIZER\BIONTECH,IM 1094912,IN,59.0,M,One day after shot i started uncontrollable nose bleeds. Wen to the ER twice locally. Sent to specific location via ambulance for a surgery to stop bleeds.,Not Reported,,Not Reported,Yes,3.0,Not Reported,U,03/07/2021,03/08/2021,1.0,OTH,Verapamil Enbrel Methotreaxte escitalopram,none,Rhuematoid Arthritis,,none,['Epistaxis'],1,JANSSEN,SYR 1094917,IL,55.0,M,"Patient states they received Vaccine on Monday, became confused at work on Tuesday and then presented to ED after multiple seizures overnight Wednesday and then was having trouble ambulating. also complains of left elbow pain",Not Reported,,Not Reported,Yes,,Not Reported,,03/08/2021,03/09/2021,1.0,UNK,"Lamotrigine, fluvoxamine, dexamethasone",,Seizure,,KNDA,"['Arthralgia', 'Condition aggravated', 'Confusional state', 'Gait disturbance', 'Seizure']",UNK,JANSSEN, 1094919,OK,51.0,M,"Covid vaccine given at 1255, started having tachycardia at 1530 reports heart rate was 143, PCP recommended to wait a couple of hours to see if heart rate would decrease and it didn't so patient went to ER at 1730. Was transferred via ambulance to Hospital at 2213. Diagnosed with Supraventricular Tachycardia on 03-9-21.",Not Reported,,Yes,Yes,,Not Reported,U,03/09/2021,03/09/2021,0.0,PUB,"Lisinopril, Metformin, and Cinammon capsules/tablets","Self diagnosed ""gallstone"" in mid February 2021","Hypertension, Diabetes",,None reported,"['Electrocardiogram', 'Supraventricular tachycardia', 'Tachycardia']",1,JANSSEN,IM 1094924,WA,,F,"Anaphylactic reaction, lips and tongue numb, face swelling, SOB, nausea, diaphoresis,double vision, weakness; all within 15 munutes.. Taken to urgent care at same site as vavcine. Given epi-pen, IV benadryl, put on oxygen. Predisone 50 mg qd X 2 days, oral benadryl 50 mg q 6 hrs X 48 hours.",Not Reported,,Yes,Not Reported,,Not Reported,Y,03/10/2021,03/10/2021,0.0,PVT,"Sertraline, Cyclobenzaprine, gabapentin, levothyroxine",None,"Asthma, fibromyalgia,",,"Paroxetine, sulpha drugs, cilantro","['Anaphylactic reaction', 'Asthenia', 'Blood pressure increased', 'Diplopia', 'Dyspnoea', 'Heart rate increased', 'Hyperhidrosis', 'Hypoaesthesia oral', 'Nausea', 'Oxygen saturation decreased', 'Swelling face']",1,PFIZER\BIONTECH,IM 1094935,WI,96.0,F,COVID Testing Positive. Hypoxia.,Not Reported,,Not Reported,Yes,,Not Reported,U,02/22/2021,03/10/2021,16.0,PVT,,,,,,"['COVID-19', 'Hypoxia', 'SARS-CoV-2 test positive']",2,MODERNA,IM 1094949,GA,68.0,F,"On March 5th I experienced shortness of breath around 1:30 that lasted for 10 minutes. I had no other symptoms and it subsided. On 3/9 around 2:30 am I had another episode of shortness of breath that lasted about 5 minutes. I was able to return to sleep. I went to work that morning and had shortness of breath, sweating, and dizziness. I drove myself to the ER where I was diagnosed with an acute saddle pulmonary embolism. I was admitted and started on IV heparin. On 3/10, I was also found to have a DVT in my right leg.",Not Reported,,Yes,Yes,5.0,Not Reported,N,03/03/2021,03/05/2021,2.0,PUB,Estradiol 1mg daily Lisinopril 2mg daily,None,None,,None,"['Blood test', 'Computerised tomogram thorax', 'Deep vein thrombosis', 'Dizziness', 'Dyspnoea', 'Echocardiogram', 'Hyperhidrosis', 'Pulmonary embolism', 'Ultrasound Doppler']",2,MODERNA,SYR 1094951,CT,30.0,F,"Immediately after injection, arm felt some tingling that subsided. Within 10 minutes of receiving the vaccine, my throat began to feel tight with my tongue feeling a heaviness. I experienced some difficulty swallowing and my heart began to race. Swelling did not worsen but face became flushed and entire mouth had a stinging/numbness. Took 25mg benadryl and 20 mg Pepcid about 25 minutes after vaccine and swelling is improved. Still some residual flushed feeling in my face and tongue still feels weird but am swallowing okay despite some dry mouth.",Not Reported,,Yes,Not Reported,,Not Reported,Y,03/12/2021,03/12/2021,0.0,PVT,"Prenatal Vitamin, Vitamin D Supplement, B12 Sublingual Supplement",0,"Vitamin B12 Deficiency, Chronic Sinusitis, Asthma",,"Cetfin, Augmentin","['Discomfort', 'Dry mouth', 'Dysphagia', 'Flushing', 'Hypoaesthesia oral', 'Immediate post-injection reaction', 'Oral pain', 'Palpitations', 'Paraesthesia', 'Paraesthesia oral', 'Swelling', 'Throat tightness']",1,MODERNA,IM 1094953,CT,72.0,F,"Covid vaccine was administered on March 3 without any reactions or side effects afterwards. On 3/8 she underwent a left molar extraction. Afterwards she had persistent left-sided pain and was taking NSAIDs at the recommended doses. She was also having intermittent nausea. On 3/11 she developed a rash which appeared like erythema multiforme versus urticaria on her chest, back and extremities. She also had very minimal swelling of her upper and lower lip. She presented to the ED. No fever or leukocytosis. Noted to have AST of 10,133, ALT of 8717, T bili 2.2, ALP 143. PTT 17. We suspect NSAID induced drug injury and rash.",Not Reported,,Not Reported,Yes,6.0,Not Reported,Y,03/03/2021,03/11/2021,8.0,UNK,Acetaminophen 1?2 tabs every 8 hours as needed Albuterol 108 mcg/ACT inhaler as needed for wheezing Atorvastatin 40 mg daily Bupropion 300 mg 24-hour tablet daily Nexium 40 mg daily Trelegy Ellipta 100?62.5-25 mcg/inh Diskus inhaler 1 puff,Left molar extraction on 3/8,"hyperthyroidism on methimazole (since 2012), pre-diabetes, fibromyalgia, esophagitis secondary to GERD, COPD on 2L at night, mitral valve prolapse, Rheumatoid arthritis not on meds",,NKDA,"['Activated partial thromboplastin time shortened', 'Adverse drug reaction', 'Alanine aminotransferase increased', 'Aspartate aminotransferase increased', 'Blood alkaline phosphatase increased', 'Blood bilirubin increased', 'Erythema multiforme', 'Lip swelling', 'Nausea', 'Pain', 'Rash', 'Tooth extraction', 'Urticaria']",1,PFIZER\BIONTECH,IM 1094954,WI,75.0,F,"Nausea, vomiting, fever, generalize weakness, dehydration",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,03/11/2021,03/12/2021,1.0,PHM,"amLODIPine 5 mg oral tablet, 5 mg= 1 tab(s), Oral, DAILY, Still taking, calcium (as carbonate) 500 mg oral tablet, 1 tab, Oral, TID, carvedilol 12.5 mg oral tablet, 12.5 mg= 1 tab(s), Oral, BID, clindamycin 300 mg oral capsule, 600 mg= 2",,"Psoriasis-associated arthropathy overlap with Behcet's. Osteopenia with metatarsal fracture secondary to muscular cramp. Chronic GI issues Chronic microscopic hematuria. Osteoarthritis, advanced, severe. Chronic oral/vaginal ulcers secondary to #1. Endocrine issues including adrenal insufficiency of unknown nature, followed by Dr. Endometriosis Herpes zoster Hypertension Rheumatoid arthritis? Kidney stone Hypogammaglobulinemia Chocolate cyst of the ovary Congestive heart failure, diagnosis December 2017, followed by heart failure clinic Aneurysm of mesenteric artery IBS history Behcets with Crohn's overlab","nausea, vomiting and weakness","abatacept (headache, shortness of breath) Nondrug Allergy (rash) Tape (rash) Bee Stings (unknown) Enbrel (rash) Orencia (Shortness of breath) Remicade (Shortness of breath) azaTHIOprine (diarrhea) captopril (fatigue) codeine (gastrointestinal upset) enalapril (fatigue) levothyroxine (headahce) lisinopril (gastrointestinal upset) losartan (diarreha) penicillin (rash) traMADol (vomiting","['Asthenia', 'Blood magnesium normal', 'Blood potassium decreased', 'Dehydration', 'Haemoglobin normal', 'Nausea', 'Pyrexia', 'Vomiting', 'White blood cell count decreased']",2,PFIZER\BIONTECH,IM 1094957,CA,45.0,F,Tachycardia (rapid heart rate) - ER Visit and admitted to hospital for observation and testing,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/04/2021,03/05/2021,1.0,OTH,viatmins,none,,,goats rue,"['Laboratory test normal', 'Tachycardia']",UNK,MODERNA, 1094968,MD,76.0,F,The patient presented in the ED on 3/11/2021 with abdominal pain. She reported having diarrhea and increased number of bowel movements compared to her normal. Reason for admission: suspected acute diverticulitis at distal sigmoid.,Not Reported,,Not Reported,Yes,3.0,Not Reported,,03/02/2021,03/11/2021,9.0,PVT,"Excerdrin Tension headache, acyclovir, Lumigan, Tums, Salonpas, cyclobenzaprine, dicyclomine, Cosopt, fluoxetine, folic acid, lisinopril, mirtazapine, multivitamin, omeprazole, pravastatin, temazepam, Nasacort, warfarin",unknown,"Afib, depression, GERD, IBS",,"metronidazole, moxifloxacin, prednisone, alendronate, codeine, morphine, meperidine, valdecoxib, erythromycin, penicillin, sulfa antibiotics","['Abdominal pain', 'Diarrhoea', 'Diverticulitis', 'Frequent bowel movements']",UNK,MODERNA,IM 1094972,UT,77.0,F,"A few weeks after receiving the vaccination she felt confused, was going to drive. Ended up having a seizure she said and was taken to Hospital and then to another Hospital. Stated was there for 3 days.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/11/2021,,,PUB,generic for flaccidness for stroke 2 years ago cholesterol medicine blood pressure medicine generic med for reflux medication for seizure,no,Stroke 2 years arthritis high blood pressure,,"codeine, aspirin","['Blood test', 'Computerised tomogram', 'Confusional state', 'Electroencephalogram', 'Seizure']",2,PFIZER\BIONTECH,IM 1094975,IL,89.0,M,"Patient received covid vaccine at local health department clinic on 02/25/2021 and presented to this reporters facility ED on 03/01/2021. Patient with multiple comorbidities and newly diagnosed COPD presented after SOB not relieved by new rescue inhaler. Admitted to hospital with pneumonia/sepsis. Treated, improved and discharged to home",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/25/2021,02/28/2021,3.0,UNK,,newly diagnosed COPD,"OSA, CKD, DM, afib s/p ablation, BPH s/p TURP and newly diagnosed COPD.",,"Bextra, Hydrocodone, Seldane","['Dyspnoea', 'Pneumonia', 'Sepsis']",2,MODERNA, 1094979,ND,90.0,F,Death within 60 days of COVID vaccine administration. Dose 1 on 12/23/2020 Dose 2 on 01/13/2021,Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,,01/13/2021,02/24/2021,42.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH, 1094980,MN,79.0,F,"At 1415, patient reported tingling and numbness to her lips. No c/o shortness of breath, tongue swelling or itching. At 1416- assessed by Dr., lungs clear, no stridor, slight rash to bridge of nose. At 1421- 0.3mg epinephrine IM administered. BP 130/84, HR 84, and O2 at 97% on room air. At 1431- 25mg IM of Benadryl given and at 1432, 124 mg of Solu-Medrol administered IM. Patient's vital signs continued to be monitored and remained stable over the next hour. At 1525, patient was reassessed by Dr. and was able to be discharged from clinic. 1540 - Patient's son picked her up and took her home with instructions for a competent adult to remain with her for the rest of the evening. Patient had an Epi-pen at home already and was instructed to use and call 911 if additional symptoms. The following day, patient was contacted by clinic Provider .and reported feeling fine and no new symptoms. On the morning of 3/11/21, patient called clinic with onset of facial swelling and shortness of breath. She was advised to go to the ER.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/09/2021,03/09/2021,0.0,PVT,"albuterol inhaler, aspirin, calcium-magnesium-zinc tablet, CoQ10, Fluticasone nasal spray, isosorbide mononitrate, losartan potassium, metoprolol tartrate, multivitamin, Repatha SureClick,, torsemide, zyrtec",None,"balance disorder, coronary artery disease, hyperlipidemia, hypertension, kidney disease, chronic stage III peripheral edema, prediabetes tremors, subclinical hypothyroidism",influenza vaccine per her report 15 years ago,"influenza vaccine, morphine, percocet, atorvastatin, pravastatin, zetia, crestor, contrast dye, shellfish, adhesive tape, mold and pollens","['Dyspnoea', 'Hypoaesthesia oral', 'Paraesthesia oral', 'Rash', 'Swelling face', 'Swollen tongue']",1,MODERNA,IM 1094990,ND,90.0,M,Death within 60 days of COVID vaccine administration,Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,,01/26/2021,02/24/2021,29.0,SEN,,,,,,['Death'],1,MODERNA, 1094991,TX,79.0,F,"Developed fever and chills around 6pm on day of vaccination. Severe febrile reaction. Developed respiratory distress and became unresponsive. Transported to ED where O2 sat'n on room air was 45%. Intubated and transferred to ICU. Extubated on 2/24/21 and transferred to telemetry floor with nasal cannula. Ultimately stable on room air. Treated for pulmonary edema, cardiogenic shock and acute on chronic CHF. Resolved and back to baseline by 3/4 when she was discharged.",Not Reported,,Yes,Yes,11.0,Not Reported,Y,02/21/2021,02/21/2021,0.0,UNK,"benazepril, folic acid, ibandronate, Mg oxide, metoprolol XL, #9: (Medications continued): multivitamin, red yeast rice supplement, trazodone. Possibly recent chemotherapy for breast cancer.",,"anemia, arthritis, breast cancer, CHF, H/O kidney stones, hypertension, osteoporosis, scoliosis. Debilitated.",,None known,"['Cardiac failure acute', 'Cardiac failure congestive', 'Cardiogenic shock', 'Chills', 'Endotracheal intubation', 'Intensive care', 'Pulmonary oedema', 'Pyrexia', 'Respiratory distress', 'Unresponsive to stimuli']",2,MODERNA,IM 1094993,,75.0,M,"2nd vaccine dose given on 02/16/2021, admitted to hospital on 02/24/2021 CARDIAC ARREST RECTAL BLEEDING died on 03/03/2021",Yes,03/03/2021,Not Reported,Yes,,Not Reported,,01/26/2021,03/03/2021,36.0,PVT,,,,,,"['Cardiac arrest', 'Death', 'Rectal haemorrhage']",2,PFIZER\BIONTECH,IM 1094995,CO,71.0,M,"Moderna COVID- 19 Vaccine EUA: Patient presented to emergency department two days after receiving vaccination and three days after symptoms of feeling ill and body aches started. Patient also reports fatigue and back pain. On exam patient had myalgias, dyspnea, cough, chills, fatigue, tachypnea (23 breaths per minute), and fever (39 degrees Celsius). Other vital signs within normal ranges. Administered intravenous fluids and antibiotics and admitted to another facility for further treatment. Patient discharged to home two days later with symptoms either resolved or returned to baseline.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/20/2021,02/22/2021,2.0,PVT,"apixaban, diltiazem, flecanide, lorazepam, losartan, magnesium oxide, ondansetron, oxycodone, potassium chloride, prochlorperazine, K-PHOS neutral, tamsulosin, vitamin B1, vancomycin oral, experimental chemotherapy","stage IV mesothelioma, recurrent c. difficile infection, deep vein thrombosis requiring anticoagulation, worsening dyspnea on home oxygen, worsening back pain, body aches and feeling unwell","atrial fibirllation, GERD, hypertension, emphysema, arthralgias, BPH",,None reported,"['Back pain', 'Blood culture negative', 'Chest X-ray abnormal', 'Chills', 'Condition aggravated', 'Cough', 'Culture urine negative', 'Dyspnoea', 'Fatigue', 'Lung opacity', 'Magnetic resonance imaging spinal abnormal', 'Malaise', 'Metastases to spine', 'Myalgia', 'Pain', 'Pleural effusion', 'Pyrexia', 'SARS-CoV-2 test negative', 'Tachypnoea']",2,MODERNA,IM 1095000,MD,79.0,F,Patient presented to the ED 3/11/2021 after rolling out of bed and landing on her right knee. Patient reported pain of the right knee but denies any other symptoms.,Not Reported,,Not Reported,Yes,2.0,Not Reported,,03/10/2021,03/11/2021,1.0,PVT,"Eliquis, Caltrate+D, clonidine, gabapentin pravastatin, Wixela, zafirlukast",unknown,"Diabetes, hyperlipidemia, hypertension, NSTEMI",,"pantoprazole, penicillin, amoxicillin, Augmentin, codeine, oxycodone, hydrocodone/APAP","['Arthralgia', 'Fall']",1,PFIZER\BIONTECH,IM 1095001,,96.0,F,Death within 60 days of receiving COVID vaccine,Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,,01/26/2021,02/05/2021,10.0,SEN,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1095020,AL,66.0,M,Passed out then was brain dead . Death,Yes,03/06/2021,Yes,Yes,2.0,Not Reported,N,03/01/2021,03/05/2021,4.0,PVT,,,,,,"['Brain death', 'Death', 'Loss of consciousness']",2,PFIZER\BIONTECH, 1095025,,65.0,U,"shortness of breath 3 days after 2nd dose injected. admitted on 2/19 shortness of breath admitted on 2/26 shortness of breath admitted on 3/2 cardiac arrest, neck mass, seizure like activity, acute respiratory failure died on 3/06/2021",Yes,03/06/2021,Not Reported,Yes,,Not Reported,,01/26/2021,02/19/2021,24.0,PVT,,,,,,"['Acute respiratory failure', 'Cardiac arrest', 'Death', 'Dyspnoea', 'Neck mass', 'Seizure like phenomena']",2,PFIZER\BIONTECH,IM 1095030,MA,54.0,M,"After 1st injection (1/11/21) experienced severe shortness of breath with minimal activity with accelerated heart rate and drop in O2 stat. within 2 days of injection then developed wheezing cough. Primary MD prescribed Augmentin nd prednisone with eventual success. With normal blood work, chest x-ray and negative Covid test all done by 1/15. On 3/9/21 (28) days after second dose (2/11/21) experienced burning and swelling on right leg. Went to Hospital, ER and found extensive blood clots in right leg and saddle pulmonary embolism . Also had 50% Platelet blood count decrese since the 1/15 bloodwork Admitted for 3 nights on heparin dip. Discharge on home Lovenox injections for 30days.",Not Reported,,Yes,Yes,3.0,Not Reported,N,02/11/2021,03/08/2021,25.0,PVT,none,respiratory virus,none,,none,"['Blood test normal', 'Burning sensation', 'Chest X-ray', 'Computerised tomogram', 'Cough', 'Dyspnoea', 'Echocardiogram abnormal', 'Heart rate increased', 'Oxygen saturation decreased', 'Peripheral swelling', 'Platelet count decreased', 'Pulmonary embolism', 'SARS-CoV-2 test negative', 'Thrombosis', 'Ultrasound scan', 'Wheezing']",2,MODERNA,IM 1095038,,82.0,F,death,Yes,02/02/2021,Not Reported,Not Reported,,Not Reported,,01/23/2021,02/02/2021,10.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1095053,,76.0,F,death,Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,,01/07/2021,02/13/2021,37.0,UNK,,,,,,['Death'],UNK,PFIZER\BIONTECH, 1095066,IL,84.0,F,"On the morning of admission, patient had another episode. She was sitting at the kitchen table and then slumped forward unconscious. She has no memory of the episode. Daughter is unsure how long she was unconscious for. She was taken to the ER via ambulance. Head CT in the ER showed only age-related changes. Chest x-ray showed an increase in infiltrate. Influenza test negative. Rapid COVID-19 test negative. Urinalysis only had 2+ leukocyte esterase. White count of 3.3. Cardiac enzymes negative. BNP normal. remains hospitalized at Hospital - inpatient",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,03/09/2021,03/10/2021,1.0,OTH,Current Outpatient Medications on File Prior to Encounter Medication Sig Dispense Refill ? amoxicillin-clavulanate (AUGMENTIN) 875-125 MG per tablet Take 1 tablet by mouth 2 times daily for 7 days 14 tablet 0 ? azithromycin (ZITHROMAX) 250,,,,nka,"['Alanine aminotransferase normal', 'Albumin globulin ratio', 'Amnesia', 'Arteriogram carotid abnormal', 'Aspartate aminotransferase normal', 'Basophil percentage decreased', 'Bilirubin urine', 'Blood albumin decreased', 'Blood alkaline phosphatase normal', 'Blood calcium decreased', 'Blood chloride normal', 'Blood creatine phosphokinase normal', 'Blood creatinine normal', 'Blood culture negative', 'Blood glucose normal', 'Blood lactic acid', 'Blood magnesium normal', 'Blood potassium normal', 'Blood sodium normal', 'Blood urea normal', 'Blood urine absent', 'Brain natriuretic peptide normal', 'Carbon dioxide decreased', 'Carotid arteriosclerosis', 'Cerebral atrophy', 'Chest X-ray abnormal', 'Chromaturia', 'Computerised tomogram head', 'Electrocardiogram', 'Eosinophil count', 'Eosinophil percentage', 'Full blood count abnormal', 'Glomerular filtration rate decreased', 'Glucose urine absent', 'Haematocrit normal', 'Haemoglobin normal', 'Immature granulocyte count increased', 'Influenza virus test negative', 'International normalised ratio normal', 'Loss of consciousness', 'Lung infiltration', 'Lymphocyte count normal', 'Lymphocyte percentage decreased', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin normal', 'Mean cell volume normal', 'Mean platelet volume normal', 'Monocyte count normal', 'Monocyte percentage increased', 'Neutrophil count decreased', 'Neutrophil percentage decreased', 'Nitrite urine absent', 'Platelet count normal', 'Pleural effusion', 'Posture abnormal', 'Protein total normal', 'Protein urine absent', 'Prothrombin time normal', 'Red blood cell count normal', 'Red blood cell nucleated morphology', 'Red cell distribution width normal', 'SARS-CoV-2 test negative', 'Suspected product contamination', 'Syncope', 'Troponin I normal', 'Urine ketone body absent', 'Urine leukocyte esterase', 'Urobilinogen urine increased', 'White blood cell count decreased', 'White blood cells urine negative', 'pH urine normal']",1,JANSSEN,IM 1095067,CA,77.0,M,"After Does 1, I broke out into hives, I was given prednisone and the swelling and itching did go down. After dose 2, The hives returned and I developed plaque psoriasis all over my body in perhaps 20 locations. I was given prednisone again, the itching stopped but The psoriasis remains and is getting worse. As a note, I have had psoriasis for most of my life on my hands and feet, but after this experience I have psoriasis all over my body.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/27/2021,02/01/2021,5.0,PVT,"Trumfia,Wellbutrin, pantoprazole, Cialis, alfsosine, multivitamin, vitamin D 3, Fish oil, iron,","Psoriasis on hand and heels,Gerd, depression, anxiety,","Psoriasis, Gerd",,"Lactose intolerant, seasonal allergies,","['Condition aggravated', 'Pruritus', 'Psoriasis', 'Swelling', 'Urticaria']",2,PFIZER\BIONTECH,IM 1095070,,71.0,F,SHORTNESS OF BREATH Respiratory distress Hypoxia Pneumonia due to COVID-19 virus Death,Yes,03/02/2021,Not Reported,Yes,,Not Reported,,02/09/2021,02/25/2021,16.0,UNK,,,,,,"['COVID-19 pneumonia', 'Death', 'Dyspnoea', 'Hypoxia', 'Respiratory distress']",1,PFIZER\BIONTECH,IM 1095075,CA,39.0,M,"I was contacted by my son requesting help obtaining medical treatment following his COVID vaccination. Per patient, immediately after being injected he had severe shoulder pain and since receiving the vaccine he has been unable to use his arm. His arm has been in a sling and he is being denied further medical evaluation. The Nurse who was present suggested he contact his family adding that the doctor injected too high. He had the second vaccine with no adverse reaction.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/04/2021,02/04/2021,0.0,OTH,None,None,None,,None,"['Arthralgia', 'Immediate post-injection reaction', 'Injected limb mobility decreased', 'Product administered at inappropriate site']",UNK,MODERNA,SYR 1095076,MD,74.0,M,Patient presented to the ED on 3/11/2021 with generalized weakness and vomiting. He denied abdominal pain or diarrhea. Patient is currently on oral chemotherapy.,Not Reported,,Not Reported,Yes,2.0,Not Reported,,03/08/2021,03/11/2021,3.0,PVT,"Zytiga, aspirin, atorvastatin, carvedilol, escitalopram, ferrous sulfate, furosemide, hydralazine, lisinopril, megestrol, metformin, oxybutynin, prednisone, FLorastor, Tamsulosin, Toujeo, trazodone, turmeric",oral chemotherapy/cancer,"depression, CAD post CABG, type 2 DM, hypertension, prostate cancer, hyperlipidemia, heart failure",,no known allergies,"['Asthenia', 'Vomiting']",1,MODERNA,IM 1095078,MI,83.0,F,Pt came to ER on 3/2/2021 with complaints of leg pain after the second COVID shot that were not getting better.,Not Reported,,Not Reported,Yes,10.0,Not Reported,U,02/17/2021,03/02/2021,13.0,OTH,"Lipitor 40mg daily, Lisinopril 40mg daily, metoprolol 25mg twice a day,","CAD, PVD, HTN, Hyperlipidemia,",,,"Sulfa, codeine","['Pain in extremity', 'Platelet count decreased']",2,PFIZER\BIONTECH,IM 1095080,CA,67.0,F,"The morning after my second shot I had chill. I covered up and fell asleep for about one hour. When I woke up the chills were gone. Just then I felt strong pain in my lower back. This pain has been with me ever since. I spoke to my doctor. She recommended Advil and Tylenol around the clock for a few days. Also Flexaril, muscle relaxer at night. I did this for three days. Also she recommended some gentle stretches and the application of heat. I am following these directives. The pain persists.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/23/2021,02/24/2021,1.0,PVT,None,None,None,,None known,"['Back pain', 'Chills']",2,MODERNA,IM 1095081,,90.0,F,Death,Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,,01/28/2021,02/21/2021,24.0,PVT,,,,,,['Death'],1,MODERNA,IM 1095109,WY,70.0,F,"At 3:00 pm 3/11/21 patient's son phoned with patient present stating patient had chest pain and felt heaviness in chest, this nurse recommended and encouraged patient's son to phone 911 and patient to go to ER. This nurse followed up with patient 3/12/21 1:50 pm and patient was taken to ER 3/11/21 and given nitro, patient then declined diagnostic testing. Pt kept for overnight observation and sent home 3/12/21 10 am.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/11/2021,03/11/2021,0.0,PUB,spironolactone furosemide propranolol atorvastatin losartan hydralazine omeprazole lorazepam clopidogrel anoro inhaler risedronate,,HTN high cholesterol type 2 DM esophageal reflux hx heart attack hx rheumatic heart disease,,,"['Chest discomfort', 'Chest pain']",1,PFIZER\BIONTECH,IM 1095111,,73.0,F,Admitted on 2/17/2021 2nd dose injected on 2/20/2021 Shortness of breath died on 03/04/2021,Yes,03/03/2021,Not Reported,Yes,,Not Reported,,01/30/2021,02/17/2021,18.0,PVT,,,,,,"['Death', 'Dyspnoea']",2,PFIZER\BIONTECH,IM 1095124,,75.0,F,"Chest pain DOE (dyspnea on exertion) Pneumonia of both lungs due to infectious organism, unspecified part of lung Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present Death",Yes,01/31/2021,Not Reported,Yes,,Not Reported,,01/22/2021,01/31/2021,9.0,PVT,,,,,,"['Chest pain', 'Death', 'Dyspnoea exertional', 'Pneumonia', 'Pulmonary embolism']",1,PFIZER\BIONTECH,IM 1095125,MD,85.0,M,"On 3/11/2021 the patient presented to the ED with diarrhea x 4 days, weakness, lightheadedness. The patient was found to have metabolic acidosis secondary to diarrhea. There are also liver lesions suggestive of metastatic disease.",Not Reported,,Not Reported,Yes,2.0,Not Reported,,03/02/2021,03/11/2021,9.0,PVT,"Vitamin C, Eliquis, Centrum Silver, losartan, metoprolol succinate, Omega 3-6-9, pravastatin, tamsulosin",unknown,"Pancreatic cancer, HTN, CAD, afib",,"ACE inhibitors, iodinated contrast media, iodine, lisinopril, penicillin, shellfish, triamterene/hydrochlorothiazide","['Asthenia', 'Diarrhoea', 'Dizziness', 'Hepatic lesion', 'Metabolic acidosis', 'Metastatic neoplasm']",2,MODERNA,IM 1095140,,76.0,F,death,Yes,03/03/2021,Not Reported,Not Reported,,Not Reported,,01/30/2021,03/03/2021,32.0,UNK,,,,,,['Death'],1,PFIZER\BIONTECH, 1095149,,86.0,M,death,Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,,02/11/2021,02/15/2021,4.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1095160,,93.0,F,death,Yes,02/19/2021,Not Reported,Not Reported,,Not Reported,,01/26/2021,02/19/2021,24.0,PVT,,,,,,['Death'],1,MODERNA,IM 1095170,MI,77.0,F,"patient status started to decline within a few hours of receiving her covid vaccine she was weak, developed increased shortness of breath and went to the emergency room were she was diagnosed with STEMI and within 2 days expired.",Yes,03/06/2021,Not Reported,Yes,2.0,Not Reported,N,03/01/2021,03/03/2021,2.0,UNK,"Aspirin, furosemide, duoneb, KCL,",COPD,COPD,,NKDA,"['Acute myocardial infarction', 'Asthenia', 'Death', 'Dyspnoea', 'General physical health deterioration']",1,MODERNA, 1095174,,77.0,M,Cardiac arrest Acute respiratory failure with hypoxia Death,Yes,02/13/2021,Not Reported,Yes,,Not Reported,,02/03/2021,02/13/2021,10.0,PVT,,,,,,"['Acute respiratory failure', 'Cardiac arrest', 'Death']",1,PFIZER\BIONTECH,IM 1095175,MD,84.0,M,"The patient presented to the ED on 3/11/2021 with fatigue for a few weeks, and recent abdomen pain. The patient was found to be hyponatremic and there was also evidence of a CVA on MRI findings.",Not Reported,,Not Reported,Yes,2.0,Not Reported,,02/26/2021,03/11/2021,13.0,PVT,"aspirin, vitamin D3, fish oil-omega-3, glimepiride, Imbruvica, lisinopril, lorazepam, nifedipine, Miralax, risperidone, Anoro Ellipta, PreserVision",CLL on ibrutinib,"CLL, CAD, hypertension, type 2 DM, stage 2 CKD, renal artery stenosis, COPD, anxiety",,no known allergies,"['Abdominal pain', 'Blood sodium decreased', 'Cerebrovascular accident', 'Fatigue', 'Hyponatraemia', 'Magnetic resonance imaging head abnormal']",1,PFIZER\BIONTECH,IM 1095183,,83.0,F,Death,Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,,02/15/2021,03/01/2021,14.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1095184,KY,67.0,F,"""Pfizer-BioNTech COVID-19 Vaccine EUA"" Patient was discovered deceased this morning by her family members.",Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,03/11/2021,03/12/2021,1.0,PVT,"Symbicort 2 inhalations BID, fluoxetine 40 mg QD, Lasix 40 mg BID prn, isosorbide 30 mg QD, lisinopril 20 mg QD, metoprolol 50 mg , mirtazapine 7.5 mg tablet, potassium chloride 10 mEq capsule,extended release, prednisone 10 mg tablet, ro","COPD, CHF, angina, coronary artery disease, arterioscleric heart disease, history of MI , history of AAA, peripheral vascular disease, unintended weight loss, hypertension, tobacco use","COPD, CHF, angina, coronary artery disease, arterioscleric heart disease, history of MI , history of AAA, peripheral vascular disease, unintended weight loss, hypertension, tobacco use",,none,['Death'],UNK,PFIZER\BIONTECH,IM 1095188,FL,77.0,M,"Vaccine was given high on arm using 1 1/2 inch needle. A little pain over next few days. Went to play golf week later and during a tee shot, experienced extreme pain on biceps muscle. My doctor surmised that shot possibly went too deep and injected bicep ligament, causing weakness and when stress was applied from golf shot, ligament tore. Cause injection too high, puncturing ligament.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/13/2021,02/25/2021,12.0,SCH,"Avapro, vitamins, Xanax, antihistamine",No,"CAD, anxiety, HBP",,None known,"['Brachial artery entrapment syndrome', 'Injection site muscle weakness', 'Injection site pain', 'Ligament rupture', 'Pain', 'Product administered at inappropriate site']",1,PFIZER\BIONTECH,IM 1095212,NY,78.0,M,"Saddle Pulmonary embolus occurred on March 6th the day following his first COVID-19 vaccine. He was found to have an extensive right leg DVT but no symptoms. He has no prior history of DVT/PE, no family history of DVT/PE, No known risk factors for DVT/PE.",Not Reported,,Yes,Yes,4.0,Not Reported,Y,03/05/2021,03/06/2021,1.0,PUB,Metformin 500mg twice daily,,Type 2 diabetes mellitus; pulmonary bronchiectasis/fibrosis,,No known allergies,"['Angiogram pulmonary abnormal', 'Aortic dilatation', 'Deep vein thrombosis', 'Lung opacity', 'Pulmonary embolism', 'Pulmonary hypertension', 'Right ventricular enlargement', 'Ultrasound Doppler abnormal']",1,MODERNA,IM 1095232,IL,79.0,F,"5. Brief History and Hospital Course: Patient is a/an 79 y.o.�female�with a past history significant for HTN, HLD, and DM�who presented to facility on 3/9/2021 with complaints of severe 8/10 right jaw pain lasting 3 minutes. EKG with new left BBB and troponin mildly elevated 8-17-35-26. She was seen by Cardiology and determined to have NSTEMI and taken for cardiac cath with drug eluting stent placed to LAD. Echo was also ordered with evidence of murmur. Cavity size is normal. Wall thickness is normal. Systolic function is normal. The estimated ejection fraction is 55%. Dyssynchronous interventricular septal motion, likely related to conduction abnormality/bundle branch block. Grade I diastolic dysfunction. Annulus is severely calcified. Severely calcified and restricted opening of posterior mitral leaflet. Mild mitral valve stenosis at the max. She remained stable post stent placement. She remained on dual antiplatelet therapy",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/15/2021,03/09/2021,22.0,PVT,ALPRAZolam 0.25 MG TAKE ONE TABLET BY MOUTH THREE TIMES DAILY AS NEEDED FOR ANXIETY Patient taking differently: Take 0.25 mg by mouth 2 times daily as needed � Aspirin 81 mg Oral DAILY Atorvastatin Calcium 40 mg Oral DAILY Carvedilol 1,,,,steroid creams,"['Acute myocardial infarction', 'Antiplatelet therapy', 'Bundle branch block left', 'Cardiac murmur', 'Catheterisation cardiac', 'Conduction disorder', 'Coronary arterial stent insertion', 'Diastolic dysfunction', 'Echocardiogram abnormal', 'Ejection fraction normal', 'Electrocardiogram abnormal', 'Mitral valve calcification', 'Mitral valve stenosis', 'Pain in jaw', 'Troponin increased', 'Ventricular dyssynchrony']",2,MODERNA,IM 1095236,,82.0,M,death,Yes,02/24/2021,Not Reported,Yes,,Not Reported,,01/21/2021,02/12/2021,22.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1095238,OK,69.0,M,"Patient at the time of vaccination on 3-8-21 has having issues with shortness of breath and edema consistent with congestive heart failure, the following day on 3-9-21, he was having more issues with shortness of breath, tachycardia, low O2 saturation. He was given meds in the clinic and monitored until he was feeling better with increased O2 sats. He was found unresponsive on his housing unit one hour later and failed to respond to resuscitation efforts and was pronounced expired at 1047.",Yes,03/09/2021,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,OTH,"Lasix 40 mg daily, Potassium 10 meq daily, Novolin 70/30 insulin, gabapentin 600 mg BID, metformin 500mg BID, Naprosyn 500 mg BID, Lisinopril 20 mg daily, incruse ellipta and fluticasone/ salmeterol inhalers","covid positive 9/14/20, recently worsening of congestive heart failure with edema and shortness of breath for previous week","sarcoidosis, COPD, diabetes, HTN, congestive heart failure",,none,"['Cardiac failure congestive', 'Condition aggravated', 'Death', 'Dyspnoea', 'Oedema', 'Oxygen saturation decreased', 'Resuscitation', 'Tachycardia', 'Unresponsive to stimuli']",1,MODERNA,IM 1095246,CA,94.0,F,"Day after vaccination pt found hypotensive at facility (SBP 70), pale. Has leukocytosis. No etiology found on blood tests, exam or imaging yet.",Not Reported,,Not Reported,Yes,,Not Reported,U,03/11/2021,03/12/2021,1.0,PVT,"metoprolol, amlodipine, losartan, melatonin",,"Atrial fibrillation, pacemaker, orthostatic dizziness",,"Codeine, Sulfa","['Blood culture', 'Blood electrolytes', 'Blood lactic acid', 'Chest X-ray', 'Computerised tomogram abdomen', 'Culture urine', 'Full blood count', 'Hypotension', 'Leukocytosis', 'Liver function test', 'Pallor', 'Troponin I', 'Urine analysis', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 1095254,,83.0,M,Shortness of breath Death,Yes,02/01/2021,Not Reported,Yes,,Not Reported,,01/05/2021,01/29/2021,24.0,UNK,,,,,,"['Death', 'Dyspnoea']",2,PFIZER\BIONTECH, 1095300,GA,56.0,F,"According to Medical Center's report, patient was brought to ED deceased upon arrival via EMS on 03/12/2021 at 8:57am. Patient had been seen on 3/11/2021 at same ED complaining of a heavy type of chest pain in the mid chest, also noting body aches, headache, and nausea.",Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,03/10/2021,03/11/2021,1.0,PHM,not known,not known,not known,,nka,"['Chest pain', 'Death', 'Headache', 'Nausea', 'Pain']",1,MODERNA,IM 1095327,ID,39.0,F,I was alerted on 3.11.21 by the patient's wife that patient had passed away the night after having received the vaccine. The wife informed me that she did not wake up the next morning.,Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/23/2021,0.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1095360,,84.0,F,SHORTNESS OF BREATH Bradycardia Hypothermia Cardiomyopathy Elevated troponin Acute renal failure (ARF) Death,Yes,02/23/2021,Not Reported,Yes,,Not Reported,,01/28/2021,02/22/2021,25.0,PVT,,,,,,"['Acute kidney injury', 'Bradycardia', 'Cardiomyopathy', 'Death', 'Dyspnoea', 'Hypothermia', 'Troponin increased']",2,PFIZER\BIONTECH,IM 1095373,CA,64.0,F,"Shortness of breath, chest pain. coughing, diffuse headache and some body aches, fever, chills, sweats. increased work of breathing, tachycardic, tachypnic,",Not Reported,,Yes,Yes,4.0,Not Reported,N,03/05/2021,03/05/2021,0.0,PUB,"Benazepril, Gabapentin, Glipizide, Levemir, Fish Oil, Prilosec, Zoloft",Chest Pain,"Diabetes, Dyslipidemia, Depression,",,"Metformin, Statins","['Chest pain', 'Chills', 'Cough', 'Dyspnoea', 'Endotracheal intubation', 'Headache', 'Hyperhidrosis', 'Pain', 'Pyrexia', 'Sedative therapy', 'Tachycardia', 'Tachypnoea']",1,PFIZER\BIONTECH,SYR 1095392,GA,66.0,F,"Received shot 02/04/2021, sudden Cardiac Arrest 2/8/2021, found 2/10/2021",Yes,02/08/2021,Not Reported,Not Reported,,Not Reported,N,02/04/2021,02/08/2021,4.0,UNK,Brilinta 90mg 2/day Valsartan 80mg 1/day Rosuvastatin 20ms 1/day Bupropion SL 150mg 1/day Asprin 81mg 1/day,none,Heart stent June 2020,,none known,['Cardiac arrest'],1,PFIZER\BIONTECH,IM 1095393,WY,76.0,M,Cardiac Arrest,Yes,03/11/2021,Not Reported,Not Reported,,Not Reported,N,03/11/2021,03/11/2021,0.0,PUB,"Aspirin, Vitamin D",None,Coronary Artery Disease,,NKDA,"['Cardiac arrest', 'Toxicologic test']",1,MODERNA,IM 1095406,,79.0,M,death,Yes,03/04/2021,Not Reported,Yes,,Not Reported,,02/04/2021,02/08/2021,4.0,PVT,,,,,,['Death'],1,MODERNA,IM 1095424,,92.0,F,death,Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,,01/09/2021,02/21/2021,43.0,UNK,,,,,,['Death'],UNK,PFIZER\BIONTECH, 1095435,TX,51.0,F,"Headache, nausea on 1/25 progressed to SOB 1/26 and death 1/27",Yes,01/27/2021,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/25/2021,14.0,UNK,Atenolol,Feeling nauseated vomiting with headache,None,,,"['Autopsy', 'Death', 'Dyspnoea', 'Headache', 'Nausea', 'Pulmonary embolism']",1,MODERNA,IM 1095437,,91.0,M,2nd dose injected on 02/19/2021 death on 2/24/2021,Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,,01/23/2021,02/24/2021,32.0,PVT,,,,,,['Death'],2,PFIZER\BIONTECH,IM 1095452,LA,56.0,M,"Patient presented to the Emergency Department of our hospital with report of nausea, vomiting, fever and chills after receiving a COVID-19 vaccination at the local Health Center. Specific information regarding the vaccine (lot number, vaccination site, etc.) is not available to me at the time of this report as the vaccination was not administered by our organization.",Not Reported,,Not Reported,Yes,,Not Reported,N,03/09/2021,03/09/2021,0.0,OTH,"Aspirin, Atorvastatin calcium, Carvedilol, CoQ10, Coreg, Entresto, Furosemide, Spironolactone",,"Cardiac disease, CHF, hypertension",,None known,"['Chills', 'Computerised tomogram abdomen', 'Full blood count', 'Metabolic function test', 'N-terminal prohormone brain natriuretic peptide', 'Nausea', 'Pyrexia', 'Urine analysis', 'Vomiting']",UNK,JANSSEN, 1095456,,91.0,F,date of injection 01/30/2021 CARDIAC ARREST 1/30/2021 Death 1/30/2021,Yes,01/30/2021,Not Reported,Yes,,Not Reported,,01/20/2021,02/15/2021,26.0,PVT,,,,,,"['Cardiac arrest', 'Death']",1,MODERNA,IM 1095536,,85.0,F,2nd injection given on 02/16/2021 Altered Mental Status admission on 3/3/2021 Intracranial bleeding Unresponsive Intracranial bleed Death on 3/6/2021,Yes,03/06/2021,Not Reported,Yes,,Not Reported,,01/23/2021,03/03/2021,39.0,PVT,,,,,,"['Death', 'Haemorrhage intracranial', 'Mental status changes', 'Unresponsive to stimuli']",2,UNKNOWN MANUFACTURER,IM 1095545,,81.0,F,death,Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,,01/21/2021,02/13/2021,23.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1095555,,81.0,M,Death,Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,,02/04/2021,02/09/2021,5.0,PVT,,,,,,['Death'],1,MODERNA,IM 1095562,,69.0,F,death,Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,,02/06/2021,02/26/2021,20.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1095571,,87.0,M,death,Yes,02/05/2021,Not Reported,Not Reported,,Not Reported,,01/07/2021,02/05/2021,29.0,UNK,,,,,,['Death'],1,PFIZER\BIONTECH,UN 1095589,,96.0,F,death,Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,,01/20/2021,01/23/2021,3.0,SEN,,,,,,['Death'],1,PFIZER\BIONTECH,UN 1095596,,70.0,F,cardiac arrest death,Yes,02/23/2021,Not Reported,Yes,,Not Reported,,02/05/2021,02/23/2021,18.0,PVT,,,,,,"['Cardiac arrest', 'Death']",1,MODERNA,IM 1095605,,97.0,M,death,Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,,01/26/2021,02/10/2021,15.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1095636,,89.0,F,death,Yes,02/27/2021,Not Reported,Not Reported,,Not Reported,,01/29/2021,02/19/2021,21.0,PVT,,,,,,['Death'],2,PFIZER\BIONTECH,IM 1095642,,94.0,M,death,Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,,01/25/2021,02/15/2021,21.0,PVT,,,,,,['Death'],2,PFIZER\BIONTECH,IM 1095659,,83.0,F,death,Yes,02/16/2021,Not Reported,Not Reported,,Not Reported,,02/06/2021,02/16/2021,10.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1095666,WV,74.0,M,"Patient received his 2nd dose of Moderna COVID-19 vaccine yesterday. He was found dead at his home today. After speaking with the County Coroner, an autopsy is not planned. Patient had COPD, Type II Diabetes, cardiovascular disease, and a pacemaker. The coroner does not believe vaccination was contributory to his death.",Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,,03/11/2021,03/12/2021,1.0,PUB,Unknown,Unknown,COPD Diabetes Cardiovascular Disease Pace Maker,,Unknown,['Death'],2,MODERNA,IM 1095668,ME,62.0,M,"62 yo M with no known medical history awoke 12:15 am on 3/11/2021 and told his wife he had ""pain all over"". When she asked if it was chest pain, he said he didn't know. He went downstairs, vomited, slumped over against the wall behind the couch, and became unresponsive. Wife called 911 and was instructed to begin CPR. EMS crew arrived shortly after that and performed prolonged resuscitation efforts as per ACLS protocol. Pt pronounced at 3:15 am. Patient had not seen a physician in many years, had not had any vaccines in over 20 years, took no medications, and had no known medical history. He did have a strong family history of heart disease and had told his wife the week prior to his death that he had suffered a several-hour bout of chest pain that resolved spontaneously 2-3 days prior to his telling her about it. He refused to seek medical evaluation despite her urging.",Yes,03/11/2021,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/11/2021,7.0,OTH,none,none,none known (had not seen health care provider in years),,none,"['Chest pain', 'Death', 'Pain', 'Posture abnormal', 'Resuscitation', 'Unresponsive to stimuli', 'Vomiting']",1,PFIZER\BIONTECH,IM 1095695,,84.0,M,death,Yes,02/18/2021,Not Reported,Not Reported,,Not Reported,,01/30/2021,02/18/2021,19.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1095705,,78.0,F,RESPIRATORY DISTRESS death,Yes,,Not Reported,Yes,,Not Reported,,02/20/2021,02/24/2021,4.0,PVT,,,,,,"['Death', 'Respiratory distress']",1,PFIZER\BIONTECH,IM 1095725,,77.0,M,death,Yes,03/07/2021,Not Reported,Not Reported,,Not Reported,,02/05/2021,03/07/2021,30.0,PVT,,,,,,['Death'],1,MODERNA,IM 1095737,,75.0,M,Shortness of breath Acute on chronic renal failure Abnormal LFTs Death,Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,,01/21/2021,02/17/2021,27.0,PVT,,,,,,"['Acute kidney injury', 'Death', 'Dyspnoea', 'Liver function test abnormal']",1,MODERNA,IM 1095748,,73.0,M,death,Yes,03/02/2021,Not Reported,Not Reported,,Not Reported,,03/01/2021,03/02/2021,1.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1095757,,82.0,M,Death,Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,,01/07/2021,01/16/2021,9.0,UNK,,,,,,['Death'],UNK,PFIZER\BIONTECH,UN 1095765,,80.0,F,death,Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,,01/23/2021,02/03/2021,11.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1095771,,95.0,F,death,Yes,03/04/2021,Not Reported,Not Reported,,Not Reported,,01/20/2021,03/04/2021,43.0,SEN,,,,,,['Death'],UNK,PFIZER\BIONTECH,UN 1095779,,82.0,M,death,Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,,02/02/2021,02/24/2021,22.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1095791,,85.0,F,Hip pain death,Yes,03/03/2021,Not Reported,Not Reported,,Not Reported,,02/06/2021,02/15/2021,9.0,PVT,,,,,,"['Arthralgia', 'Death']",1,PFIZER\BIONTECH,IM 1095798,,94.0,U,death,Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,,01/20/2021,02/21/2021,32.0,PVT,,,,,,['Death'],1,MODERNA,IM 1095848,PA,83.0,F,"Hours after receiving the 1st Moderna Vaccine patient realized left arm would not move at all and left leg was weak and dragging. Called ambulance and was transported to Hospital. No other signs of a stroke, other than paralyzed left arm and weak leg. Initial scans did not show a stroke. Patient could talk fine, smile, etc. Ran tests in ER, then admitted patient. Treated with muscle relaxers given arm was bent and stiff and would not move. After admitted, the next day an MRI was performed and indicated a stroke in the part of the brain which affects the left side. Began treatment for stroke with blood thinners, etc. Patient moved to Rehab after 4 days in hospital. Remained in Rehab until Monday, March 15th then discharged with weakness in arm and leg remaining.",Not Reported,,Not Reported,Yes,36.0,Not Reported,N,02/06/2021,02/07/2021,1.0,OTH,Atorvastatin Calcium Ditilazem Hydrochloride Losartin Potassium,None,Rhuematoid Arthritis Shogrun's Disease (dry eyes and mouth) High Blood Pressure,,Chocolate Actonel (medication),"['Blood test', 'Cerebrovascular accident', 'Gait disturbance', 'Hemiparesis', 'Magnetic resonance imaging head abnormal', 'Mobility decreased', 'Monoplegia', 'Musculoskeletal stiffness', 'Scan']",1,MODERNA,SYR 1095862,WA,87.0,M,"received a phone call from the daughter of the patient. On 01/21/2021, patient came in and got his first Covid Vaccination. 3 days after the vaccination, the patient experienced really bad diarrhea, and was sleeping for 22 hours a day. 2 weeks later he perked up a little bit. On 02/23/2021, patient received his booster. Daughter states that 2 days later, patient shut down completely, not eating or drinking. The patient ended up passing away on 03/05/2021.",Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/25/2021,2.0,PVT,Unknown,Alzheimers,Alzheimers,,Unknown,"['Death', 'Diarrhoea', 'Hypersomnia', 'Hypophagia']",2,MODERNA,IM 1095879,OH,47.0,M,"Diagnosed with Bell's Palsy and having headache. On Saturday went to ER, did CT scan . Saw PCP on Monday.",Not Reported,,Not Reported,Yes,,Not Reported,N,03/05/2021,03/05/2021,0.0,PUB,"Lantis, Lopresser",no,"Diabetes, Hypertension",,no,"[""Bell's palsy"", 'Blood test', 'Computerised tomogram', 'Electrocardiogram', 'Headache']",1,MODERNA,IM 1095908,WI,92.0,F,"A customer came with questions regarding dizziness they have been having since receiving the second dose of the Moderna vaccine. She states that any time she takes a step down (not up), she feels very dizzy. She has started using a cane because of this which she is dissatisfied with. This started after she got the second dose on the 10th of March, and has been continual for her since then. She is not our patient and we do not have any real information about her except that she received both of her doses from the Health Department.",Not Reported,,Not Reported,Not Reported,,Yes,N,03/10/2021,03/10/2021,0.0,PHM,Unknown,Unknown,Unknown,,Unknown,"['Dizziness', 'Walking aid user']",2,MODERNA, 1095915,NY,27.0,F,"I got a blood clot in my left leg, as well as numerous blood clots in both my lungs. I have never had a blood clot before, and my family does not have a history of them.",Not Reported,,Yes,Yes,1.0,Not Reported,N,02/14/2021,02/22/2021,8.0,OTH,,,,,,"['Computerised tomogram', 'Thrombosis', 'Ultrasound scan', 'X-ray']",2,MODERNA,IM 1095921,TX,41.0,F,"I?ve experienced severe allergic reactions to many things. I?m now allergic to soy, yeast, wheat, coffee, casein (dairy) peanuts, green beans/ legumes, eggs, onion and celery. I?ve had a huge rash that broke out on my left arm that started at the spot where I received the injection. Now I?ve been experiencing my mouth and tongue swelling to the point that my throat has closed up. I?ve been hospitalized as air wasn?t going through my body. I had to inject an Epi-pen in my leg, and be taken to the hospital. I?m currently on high dosage prednisone, Benadryl and several other meds to address the swelling in my tongue that happens daily. I am desperate to find out if there is anyway to stabilize anything that vaccine had in it to see if this condition will get better.",Not Reported,,Yes,Yes,2.0,Not Reported,N,01/09/2021,01/26/2021,17.0,WRK,Tylenol PM,None,None,,I had no allergies to food or medication prior to getting the first Moderna vaccine.,"['Allergy test', 'Blood test', 'Injection site rash', 'Mouth swelling', 'Oxygen saturation decreased', 'Swollen tongue', 'Throat tightness', 'Urine analysis']",1,MODERNA,SYR 1095965,UT,50.0,M,"Has not had a SZR since april of last year. He was not feeling well after vaccine, (body aches, subjective fever, tiredness) and wife found him having a seizure while lying in bed.",Not Reported,,Yes,Yes,5.0,Not Reported,Y,03/04/2021,03/05/2021,1.0,OTH,"THC (medical), lacosamide, oxcarbazepine, lamotrigine, vit c, multivitamin, naproxen, cholecalciferol, ativan",None,"Epilepsy, drug abuse history of cocaine abuse and uses THC for medical purposes (chronic pain)",,Morphine,"['Condition aggravated', 'Fatigue', 'Malaise', 'Pain', 'Pyrexia', 'Seizure']",UNK,JANSSEN, 1095977,FL,81.0,F,"early next morning got up to use bathroom, and collapsed on bathroom floor, went in and out of consciousness and was too weak/had no energy to pull herself up from the floor. Severe diarrhea all over floor and self. Was not found until Saturday afternoon, and was transported to the ER by ambulance. Remained in hospital Saturday evening until Monday afternoon. As of today, the following Friday the 12th, she is still weak and unsteady at times, where she was previously ambulating fine with adequate energy. Still feels like she has no strength.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,03/05/2021,03/06/2021,1.0,PHM,"pravastatin 80mg, lexapro 10mg, aricept 10mg immodium 1mg, fish oil, calcium, garlic, centrum vitamins, vit c, vit b-12,",,osteoporosis,,"mushrooms, amoxicillin","['Asthenia', 'Balance disorder', 'Computerised tomogram abdomen', 'Consciousness fluctuating', 'Contusion', 'Diarrhoea', 'Head injury', 'Syncope']",2,MODERNA,SYR 1096197,TX,95.0,M,"Low pulse, lethargy, labored breathing. Oxygen was administered.",Yes,01/21/2021,Not Reported,Not Reported,,Not Reported,N,01/16/2021,01/21/2021,5.0,SEN,Not known by data enterer.,None.,"Suffered a stroke, several years earlier, rendering inability to speak clearly. Non-ambulatory for the last couple of years.",,None,"['Dyspnoea', 'Heart rate decreased', 'Lethargy']",UNK,PFIZER\BIONTECH, 1096461,PA,86.0,F,"Patient received vaccine at 10:35am, was observed for 15 minutes then returned home with family. Patient began to not feel well, experienced cardiac arrest as witnessed by son, was taken to hospital Emergency Department where she expired at 12:50pm.",Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,03/12/2021,03/12/2021,0.0,PVT,,,,,,"['Cardiac arrest', 'Death', 'Malaise']",2,PFIZER\BIONTECH,IM 1096497,FL,48.0,M,"Notified by police department that patient was found dead at his home on 3/12/21. Per the officer, the family reports patient reported diarrhea on 3/11/21 and fatigue on 3/12/21. The family found him in his home deceased later in the day on 3/12/21",Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,03/11/2021,03/12/2021,1.0,PVT,"Setraline, Methocarbamol, Pantoprazole, Gabepentin, Benztropine, Hydroxyzine, Zyrtec, Ferrous Sulfate, Memantine, Donepezil, Lamotrigine, Fluticasone, Propranolol","Bipolar Disorder, Hypertension, Allergic Rhinitis",Bipolar Disorder Hypertension Chronic Back Pain,,None,"['Death', 'Diarrhoea', 'Fatigue']",UNK,MODERNA,IM 1096600,MO,59.0,M,"Per the patient's spouse and Hospital: The patient received a rapid COVID test at clinic prior to vaccination, which read negative. The patient received vaccination on 2/23/21 and the following day (2/24/21) began to experience breathing difficulties. The patient was admitted to the emergency room at Hospital on 2/26/21 and diagnosed with hypoxic respiratory failure d/t COVID-19 (oxygen saturation < 50%). Patient was intubated on 3/2/21. Per Hospital pharmacist, patient expired on 3/12/21 at 6:40pm.",Yes,03/12/2021,Not Reported,Yes,15.0,Not Reported,N,02/23/2021,02/24/2021,1.0,OTH,Per Hospital: Patient was not taking any medications.,Unknown,"Per Hospital: hx of atrial fibrillation, diverticulitis, morbid obesity (BMI of 52)",,Per Hospital: NKA,"['COVID-19', 'Death', 'Dyspnoea', 'Endotracheal intubation', 'Respiratory failure']",2,PFIZER\BIONTECH,IM 1096602,ME,78.0,F,"Hospice nurse reported patient started experiencing fatigue, nausea, dizziness, decreased appetite and shortness of breath immediately following vaccination. Hospice medications were ordered and patient began receiving morphine and nebulizer treatments. She then started having dysphasia. She then died on 3/5/21 from presumed respiratory failure.",Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,02/25/2021,02/25/2021,0.0,PVT,"Dorzolamide-timolol eye drops, clonazepam, guaifenesin, ipratropium-albuterol, latanoprost eye drops, oxygen 5 liters via nasal cannula, refresh eye drops, ventolin HFA. Also possible hospice medications (atropine drops, haloperidol, loraze","Idiopathic pulmonary fibrosis, asthma, COPD, anxiety, CKD3, macular degeneration, GERD, glaucoma, hypercalcemia, HLD, hypothyroidism, osteoarthritis, migraines, osteopenia, post-menopausal bleeding of undetermined significance, b12 deficiency, vitamin D deficiency",See illness at time vaccination,,Tetracyclines (hives),"['Aphasia', 'Death', 'Decreased appetite', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Immediate post-injection reaction', 'Nausea', 'Respiratory failure']",1,MODERNA,SYR 1096659,NC,62.0,M,Patient died about 12 hours after receiving first dose Covid vaccine,Yes,03/13/2021,Not Reported,Not Reported,,Not Reported,N,03/11/2021,03/11/2021,0.0,UNK,,,"Asthma; hypertension Hx of respiratory arrest, cardiac arrest, stroke",,,['Death'],UNK,UNKNOWN MANUFACTURER, 1096749,VA,68.0,F,"On MON evening after the shot, at 11:00pm I experience severe chills that lasted for hours. Tuesday morning I awoke with a bad headache and had body aches all day as well as tendonitis- like pain in both lower arms. I felt somewhat better on WED but I did notice that my compression sleeve on my right arm (lymphedema arm) felt more snug than usual. That night I had severe chills and fever of 101. I slept until 11:45am on THU and felt aches all over. Very fatigued. Went back to sleep from 2:00pm until 6:00pm. Temp was down to 99.8. When I woke and removed my compression garment, my arm was red and swollen, also rash-like bumps, and was very warm to the touch. FRI morning it looked worse, so I contacted my lymphedema specialist and then my PCP. This is NOT a good situation for anyone who has lymphedema and will necessitate months of treatment.",Not Reported,,Not Reported,Not Reported,,Yes,N,03/08/2021,03/08/2021,0.0,OTH,"Flonase Sensimist, vitamin D3, Niacin, vitamin C, B complex, pro-biotic,",None.,"Lymphedema in right arm since March of 2000, post cancer treatment in 1995. Allergies to mold, dust mites, dogs and pollen - have been on shots for 6 years.",,Adverse reaction to Levoquin in 2021 - tendonitis in both arms. No allergies to foods. Have allergies to mold and dust mites. Sensitive to codiene.,"['Chills', 'Erythema', 'Fatigue', 'Full blood count abnormal', 'Headache', 'Pain', 'Pain in extremity', 'Peripheral swelling', 'Pyrexia', 'Rash', 'Skin warm', 'Tendonitis', 'White blood cell count increased']",1,JANSSEN,IM 1096913,CA,85.0,M,"My father passed away on February 10th, 2021. On Monday, January 25th 2021, he said he is feeling very uncomfortable in his chest area. He thought it was severe acid reflux. He took Gas X for Acid Reflux and told us that he does not want to go to the hospital. On Tuyesday, January 26th, he felt that his Acid Reflux symptoms got worse, he still did not want to go to the hospital. He took Tums. On that evening, he started having shortness of breath. We took his BP at home and it was very low. We begged him to go to the hospital, he still did not want to go. On Wednesday, January 27th, his shortness of breath got worse and we convinced him that he has to go to the hospital. We took him to ER. Doctor said that he had a heart attack on Monday morning and that is why he was not feeling well since Monday morning. While at the hospital, while the cardiologists were monitoring him, his heart condition got worse. By Friday, February 5th, cardiologists said that he is very fragile, his heart condition is very fragile and he won't survive any procedure. They said that something triggered the heart attack. We told them about the vaccination on 1/13/2021. They sent him home on hospice on Friday, Feburary 5th, 2021. He was on supplemental oxygen when he came home. He passed away due to a heart attack on February 10th, 2021 around 9pm.",Yes,02/10/2021,Not Reported,Yes,15.0,Not Reported,N,01/13/2021,01/24/2021,11.0,PVT,"Carvedilol, Simvastatin, Clopidogrel, Aspirin, Losartan","Heart Problem, High Blood Pressure, Arthritis","Heart Problem, High Blood Pressure, Arthritis",,,"['Blood pressure decreased', 'Blood test', 'Chest discomfort', 'Death', 'Dyspnoea', 'Electrocardiogram', 'Myocardial infarction']",1,MODERNA,SYR 1096952,MI,73.0,M,Patients cancer progressed quicker than expected. Resulting in his passing,Yes,03/02/2021,Not Reported,Not Reported,,Not Reported,U,02/12/2021,03/02/2021,18.0,PHM,,Cancer,,,,['Death'],1,MODERNA,IM 1097000,PA,69.0,M,"No adverse events were immediately reported, but patient died on 7th day following vaccine",Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,,02/19/2021,02/26/2021,7.0,PUB,"Eliquis, Ezetimibe/Simvast, Humira, Hydrochlorothiazide/Valsartan, Mercaptopurine, Metformin HCl",,History of DVT/PE Fatty liver Diabetes High Cholesterol High Blood Pressure Ulcerative Colitis,,None known,['Death'],1,PFIZER\BIONTECH,SYR 1097244,CA,90.0,M,Death within 7 days of vaccine. COD Cardiac Arrest,Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,,02/08/2021,02/10/2021,2.0,OTH,,,"Atherosclerosis of Aorta, Atrial Fibrillation, unspecified, CKD Stage 3, GERD, Gout, Hypertension, Hyperlipidemia",,,"['Cardiac arrest', 'Death']",1,MODERNA,IM 1097283,CA,85.0,F,Death within 7 days of vaccine,Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,,02/03/2021,02/11/2021,8.0,OTH,,,Essential hypertension Cardiac arrhythmia Atrial flutter (CMS/HCC) Acute myocardial infarction,,,['Death'],1,MODERNA,IM 1097383,KY,79.0,M,Urticaria and angioedema with nausea/vomiting 48 hours after vaccination. Symptoms persisted responded to treatment but came back 6 days later and required further treatment with steroids.,Not Reported,,Not Reported,Yes,1.0,Not Reported,N,03/05/2021,03/08/2021,3.0,PVT,None,None,None,,None,"['Angioedema', 'Nausea', 'Urticaria', 'Vomiting']",1,JANSSEN,IM 1097520,VA,64.0,F,"I experienced fever, chills, tiredness, and headache approximately five hours after administration of the vaccine on 3-10-21. Symptoms became severe within 30 minutes thereafter, at which time I experienced difficulty standing. After five hours with no improvement, I used my home blood pressure monitor to check my BP and HR; BP was high for me, 120/90 sustained, and HR varied between 135 and 150, with 143 being the most consistent value after multiple readings. I seemed to be experiencing a ""severe allergic reaction"" per the instructions I was given and called 9-1-1. I was transported to Hospital, treated in ER, and then admitted to the intermediate care unit. I was discharged to home on 3-12-21.",Not Reported,,Yes,Yes,2.0,Not Reported,U,03/10/2021,03/10/2021,0.0,PVT,Levothyroxin 88 mcg PO qday Minoxidil 5% topical qday,None,Hypothyroidism,,NKA,"['Bundle branch block right', 'Chest X-ray normal', 'Chills', 'Computerised tomogram thorax abnormal', 'Coronary artery dissection', 'Dysstasia', 'Echocardiogram normal', 'Electrocardiogram abnormal', 'Fatigue', 'Headache', 'Hypertension', 'Pyrexia', 'SARS-CoV-2 test negative', 'Sinus tachycardia', 'Troponin increased']",,JANSSEN,IM 1098028,NY,32.0,M,"Cardiac arrest, death approx 12 hours later",Yes,03/14/2021,Not Reported,Not Reported,,Not Reported,N,03/13/2021,03/14/2021,1.0,UNK,levothyroxine,,"Hypothyroidism, MVP, valve repair",,,"['Cardiac arrest', 'Death']",UNK,JANSSEN, 1098041,FL,86.0,F,"Death, reported to pharmacy via Coroner's office",Yes,,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/12/2021,4.0,PHM,None disclosed,None disclosed,None disclosed,,Eggs-discussed prior to vaccination no other allergies listed,['Death'],1,MODERNA,IM 1098119,NE,50.0,F,"in the early am she had bad diarrhea , she went to work and then started having really bad stomach pains and before noon she had to go home because she started puking. She laid down to take a nap around 3:30pm and never woke up.",Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,N,01/22/2021,02/01/2021,10.0,OTH,Adderall 10 MG Common daily vitamin pack Bupropion 150 MG Tramadol 50 MG,,Fibromialgia Rheumatiod Arthritus,,,"['Abdominal pain upper', 'Death', 'Diarrhoea', 'Vomiting']",1,MODERNA,SYR 1098162,MN,36.0,F,"First I felt lightheaded/dizzy, then became nauseous, and my feet and hands were numb and tingling, I felt like my tongue was getting bigger but the primary care dr at the clinic didn't think so. They eventually after monitoring me for awhile sent me down to ER, by then my voice was raspy and scratchy, my lower lip was big, my tongue still felt big. I still felt nauseous. The dr asked me if my eyes are usually swollen and red and I said no. My extremities were still numb and tingling. I got epi and other drugs, zofran, benadryl, pepcid, I think a dose of steroids. The symptoms continued so I ended up getting a 2nd dose of epi. I went home around 5pm. When I woke up that evening to do a neb treatment I was nauseous, my lower lip again big, my tongue felt thick and this time my upper throat felt swollen, I gave myself epi and took myself to ER, they monitored me for 3 hrs the dr was gonna hospitalize me if I got worse, I still felt nauseous and the numbness and tingling feeling in my hands and feet when I left but was not having any airway issues when I left. Not sure if the numbness/tingly is gonna go away in my hands and feet.",Not Reported,,Not Reported,Not Reported,,Yes,N,03/13/2021,03/13/2021,0.0,PVT,,no,"on oxygen 9+ months post Covid 19 infection March 2020, started oxygen in the summer fibromyalgia since having Covid 19 eating disorder, weight stable","flu vaccine, age 25 at vaccination, severe reaction, lost sensation in my lower legs, guillain-barre reaction without motor loss",avocado flu vaccine hepatitis b vaccine zidovudine vraylar,"['Dizziness', 'Dysphonia', 'Eye swelling', 'Hypoaesthesia', 'Lip swelling', 'Nausea', 'Ocular hyperaemia', 'Paraesthesia', 'Pharyngeal swelling', 'Swollen tongue', 'Tongue disorder']",1,JANSSEN,IM 1098172,NY,60.0,F,"Chills at about 8pm on 3/6/2021. The woke with a rapid pounding heart rate just after midnight 3/7/2021. I went to the Hospital emergency room. They ran tests; ekg, blood tests, chest X-ray. They gave me fluids and Tylenol. My heart rate and blood pressure were fluctuating when I first went to the ER but then they went back to normal and I was released around 6:00pm 3/7/2021.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/06/2021,03/07/2021,1.0,OTH,"Vitamin D3, Vitamin B12",None,Mild asthma,,Keflex,"['Blood pressure fluctuation', 'Blood test', 'Chest X-ray', 'Chills', 'Electrocardiogram', 'Heart rate increased', 'Heart rate irregular', 'Palpitations']",1,JANSSEN,SYR 1098178,DC,76.0,F,"2nd dose of covid19 vaccine administered on 1/25/21 AM. First dose was about 12/28/2021. Patient had a change in condition noted same day PM, which included worsening mental status with increased confusion such as disorientation and decreased functional status, as well as opening of pressure ulcer on coccyx. Patient became lethargic. Patient condition worsened over the next few days. Patient decreased oral intakes, including medications. Care and comfort measures were in place. Patient expired on 2/4/2021.",Yes,02/04/2021,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,SEN,"Donepezil, famotidine, mirtazapine, senna, quetiapine, tramadol, sinemet, Tylenol","hypertension, parkinson's disease, dementia, incontinence","hypertension, parkinson's disease, dementia",,sulfa antibiotics,"['Confusional state', 'Death', 'Decubitus ulcer', 'Disorientation', 'General physical health deterioration', 'Hypophagia', 'Lethargy', 'Mental status changes', 'Wound dehiscence']",2,MODERNA,IM 1098299,IL,79.0,F,"Husband returned for second dose of COVID-19 vaccine and reported that wife, expired the day after her first dose of the COVID vaccine. Medical team did not feel that there was a correlation so we were not notified prior to that date",Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,OTH,,,,,none,['Death'],1,PFIZER\BIONTECH,IM 1098311,WI,106.0,U,"The nursing home gave the vaccine, I only know it was moderna",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,SEN,Nursing home has records,"The 1st vaccination didn?t bother her. She was in declining health and had weight loss over the past year, I believe partially due to not being able to see her family due to lockdowns.","Less the 48 hours after receiving her 2nd dose of Moderna she was suddenly semiconscious, unable to eat, drink, speak or open her eyes. This is when I noticed the difference in her. I wasn?t there the day after the vaccine. She?s been sick in the past but this was obviously an ending of her life. She had a fever, was restless at times, which after I received my 2nd dose can now relate to her possibly having muscle and joint aches, which I also had, but she wasn?t able to communicate this. She never recovered and passed away on February 19th. I have to live with the realization that I okayed the administration of the vaccine to protect her, and I believe it ended her life. If I had know how extreme it was for someone her age to get the vaccine, I wouldn?t have allowed it.",,Sulfa,"['Arthralgia', 'Death', 'Depressed level of consciousness', 'Feeding disorder', 'Fluid intake reduced', 'Myalgia', 'Pyrexia', 'Restlessness', 'Unresponsive to stimuli']",UNK,UNKNOWN MANUFACTURER, 1098473,MI,83.0,F,"My mother had the shot on January 25. On the 30th, she became confused and was having trouble swallowing. I took her to the hospital on the 31st (Sunday). She was admitted with pancreatitis and was unable to drink water. She was then admitted to the ICU. She became septic and her mental status declined. By Tuesday, she was placed on a ventilator. She then had renal failure and died on February 18th.",Yes,02/18/2021,Not Reported,Yes,19.0,Not Reported,N,01/25/2021,01/30/2021,5.0,UNK,naproxen amlodipine folic acid omeprazole methotrexate fosomax dorzoltimol latanoprost,taking a steroid for a lung infection.,"Pulmanary issues, rheumatoid arthritis, bronchiectasis, macular degeneration, glaucoma",,,"['Confusional state', 'Death', 'Dysphagia', 'Intensive care', 'Mechanical ventilation', 'Mental impairment', 'Pancreatitis', 'Renal failure', 'Sepsis']",1,MODERNA,SYR 1098680,CA,79.0,F,"Pt completed 2 covid vaccine morderna doses Feb 18, 2021. Pt with increasing weakness and short of breath for 3 days PTA on 3/6/2021.",Yes,03/11/2021,Not Reported,Yes,6.0,Not Reported,N,02/18/2021,03/06/2021,16.0,PVT,"Albuterol, amlodipine, lipitor, breo ellipta, flexeril, wellbutrin, premarin, prozac, levothyroxine, losartan, singulair, prilosec,","2nd toe arthroplasty surgery 3/4/2021, laminotomy, medial facetectomy and B foraminotomies L3-S1 on 2/22/21","Lumbar stenosis, hypertension, hypothryroidism, h/o breast CA, prediabetes, osteoarthritis, s/p hip replacement, anemia, gerd, asthma, cervical spondylosis with myelopathy",,Tape,"['Asthenia', 'Dyspnoea']",2,MODERNA,SYR 1098856,NY,77.0,F,"Four hours after vaccine shot, she began with a headache then severe vomiting. She became in coherent and when brought to the hospital she had a brain hemorrhage. She passed away on 3/3/2021 at 3:05pm.",Yes,03/03/2021,Yes,Yes,1.0,Not Reported,N,03/02/2021,03/02/2021,0.0,PHM,Lexapro; Mementine; Calcitonin; Iron; Magnesium; Areds; Vitamin D; Serequel; Vitamin C; Donepezil,Dementia,Dementia,,Sulfa Compazine,"['Blood test', 'Cerebral haemorrhage', 'Computerised tomogram head abnormal', 'Death', 'Headache', 'Incoherent', 'Vomiting']",1,MODERNA,SYR 1098902,FL,59.0,M,Death,Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,N,02/02/2021,02/21/2021,19.0,UNK,,"Diabetic, coronary heart disease","Diabetic, coronary heart disease",,,['Death'],1,MODERNA, 1098942,TX,34.0,M,"Janssen COVID-19 Vaccine EUA 34 y.o. male with GERD who presents with syncope and question of PEA arrest. He went for COVID 19 J&J vaccine on 3/13/2021. A few minutes after getting the vaccine he started feeling nauseated. His lips became gray. He went unresponsive and was taken out of the car. He had agonal respirations. He had 90 seconds of chest compressions and returned to his normal state of health. He was seen in ED where labs were remarkable for mild hyperkalemia (serum potassium 5.5). Given worrisome syncope, chest compression he was admitted for observation. He did well overnight, No arrhythmias of telemetry and was discharged with Holter monitor.",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/13/2021,03/13/2021,0.0,PVT,"Cefdinir 300 mg BID, Hydrocodone+Chlorpheniramine 10/8 mg BID,",,Gastroesophageal reflux disease,,NKDA,"['Agonal respiration', 'Blood potassium increased', 'Electrocardiogram ambulatory', 'Hyperkalaemia', 'Lip discolouration', 'Nausea', 'Resuscitation', 'Syncope', 'Unresponsive to stimuli']",1,JANSSEN,IM 1099173,FL,98.0,F,"1/24/20211 unresponsive, sent to Hospital. Admitted with diagnosis: Acute Ischemic left MCA stroke. 1/26/2021 Transferred to Hospice care. 01/30/2021 died. I don't believe the hospital was aware of her vaccination date as it is not recorded in her records, therefore I assume that a previous VAERS report has not been submitted. My relationship to the patient is that I am her daughter.",Yes,,Not Reported,Not Reported,,Not Reported,N,01/21/2021,01/24/2021,3.0,SEN,,,,,,"['Cerebrovascular accident', 'Death', 'Ischaemic stroke', 'Unresponsive to stimuli']",UNK,PFIZER\BIONTECH, 1099216,FL,84.0,F,PATIENT'S SISTER REPORTED PATIENT PASSED AWAY 03/07/2021,Yes,03/07/2021,Not Reported,Not Reported,,Not Reported,N,02/15/2021,03/07/2021,20.0,PHM,,,,,,['Death'],1,MODERNA,IM 1099241,CA,1.33,F,"Patient is breastfed by mother, who was vaccinated on 3/10. Patient developed jaundice 3/11, and was admitted for evaluation of hemolytic anemia. Evaluation ongoing. Likely not related to vaccine, but occurred within 2 days of possible to vaccine components via breastmilk",Not Reported,,Not Reported,Yes,,Not Reported,N,03/10/2021,03/11/2021,1.0,PVT,None,None,None,,None,"['Exposure via breast milk', 'Haemolytic anaemia', 'Jaundice']",UNK,JANSSEN, 1099326,NJ,80.0,M,"A few days after vaccination patient had an unusual dry cough/ and then a pain in his chest, He called our Doctor she said call your cardiologist now, patient called Dr and told him he wanted to go to his office, explained the pain he was experiencing - the doctor told him said he couldn't see him wanted to do a telemed exam. and proceeded to tell patient to see an gastro entomologist, take Tums, no tomatoes, no coffee and a few other foods and that patient was suffering from Acid Reflux and to call him back net week.",Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/18/2020,02/23/2021,342.0,PVT,Bepreve; Betoptic; Alphagan; Rocklatan; SystaineZaditor; Systane complete;Spiriva hand haler,None,COPD; Dystonia,,only seasonal allergies,"['Chest pain', 'Cough', 'Death', 'Gastrooesophageal reflux disease']",UNK,MODERNA, 1099363,,41.0,F,"Onset of leg weakness and instability that has progressively worsened. Constant imbalance noted more in standing and with walking resulting in feeling like I am ""rocking on a boat"" constantly. Increased sway in static standing that is more pronounced with rotational movements, eyes closed, and decreased base of support. Ataxic movements and lateral veering with walking at times. Episodes of low blood pressure/significant decrease in blood pressure from sitting to standing, tachycardia, and resting tremors in the hands that are intermittent in nature. Feeling of head being ""in the clouds"" constantly where something is not right.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/19/2021,03/03/2021,12.0,PVT,"patanol, fish oil, vitamin D, super B complex, magnesium, eye promise, sublingual allergy drops",none,history of tinnitus and hearing loss L ear (ongoing and stable since 2013); history of allergy induced asthma (well controlled with no use of inhaler or medication in greater than 1 year),,"sulfa, environmental allergies","['Balance disorder', 'Blood potassium decreased', 'Blood test normal', 'Borrelia test', 'Dizziness', 'Dysstasia', 'Electrocardiogram normal', 'Eyelid function disorder', 'Feeling abnormal', 'Gait disturbance', 'Hypotension', 'Muscular weakness', 'Resting tremor', 'Tachycardia', 'Tremor']",2,MODERNA,IM 1099429,NJ,39.0,M,First Pfizer shot on 02/01. Flu like symptoms for 3 days. Followed by overall fatigue. The. 10 days after shot ear symptoms began. Complete hearing loss in right ear. Began as 3 days of tinnitus. Then complete hearing loss. Put on steroid blast (60mg of Prednisone) by my primary. Refered to ENT. ENT ran hearing test and concluded that the hearing loss was complete. 12 days of complete hearing loss. Then repeated hearing test. Slight improvement. ENT delivered shot of steroids directly into my right ear. Hearing test repeated 10 days later. Slight improvement again. Now currently about 90% of hearing had returned to my right ear.,Not Reported,,Not Reported,Not Reported,,Yes,N,02/01/2021,02/12/2021,11.0,PVT,"Diatalizem, Clonidine, Zubsolv",None,High Blood Pressure,,None,"['Acoustic stimulation tests abnormal', 'Deafness unilateral', 'Fatigue', 'Influenza like illness', 'Magnetic resonance imaging head', 'Tinnitus']",1,PFIZER\BIONTECH,SYR 1100607,NV,55.0,M,Seizure,Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,03/12/2021,03/13/2021,1.0,PHM,NIL,NIL,NIL,,NIL,"['Computerised tomogram head normal', 'Electroencephalogram normal', 'SARS-CoV-2 test negative', 'Seizure', 'Thrombocytopenia']",UNK,JANSSEN,IM 1100210,OH,,M,"contracted COVID; Vaccine did not work out very well for him; Sweats; Fatigue; Throbbing HA; Chills; Muscle pain; Fever of 101.3; A spontaneous report was received from a consumer, concerning a 66-year-old male patient who received Moderna's COVID-19 vaccine and the vaccine did not work out very well for him (lack of effect) and he contracted COVID (COVID-19) and experienced sweats (hyperhidrosis), fatigue, throbbing headache, chills, muscle pain (myalgia) and fever of 101.3 (pyrexia). The patient's medical history was not provided. Concomitant medications reported included dabigatran etexilate mesilate, blood pressure medication, cholesterol lowering medication and bladder medication. On 06-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 039k20a) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. On 06-Jan-2021, approximately 5 hours after administration of the vaccine shot, patient experienced sweats, fatigue, throbbing headache, chills, muscle pain and fever of 101.3. On follow-up, the patient reported that the vaccine ""did not work out very well"" for him and he ""contracted COVID"" (onset date not reported) and was in the hospital. Treatment for the events included paracetamol. Action taken with mRNA-1273 in response to the events were not reported. The outcome of events, sweats, fatigue, throbbing headache, chills, muscle pain and fever of 101.3 were considered not resolved at the time of this report. The outcome of COVID was unknown. Follow-up received on 01 Mar 2021 included addition of events.; Reporter's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of COVID and the product use is assessed as unlikely. Th event was most likely pre-existing. The other events are assessed as symptoms of the COVID-19. However, fatigue, headache, chills, muscle pain and fever are consistent with the known safety profile of the vaccine and a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/06/2021,01/06/2021,0.0,UNK,PRADAXA,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['COVID-19', 'Chills', 'Drug ineffective', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Myalgia', 'Pyrexia']",1,MODERNA,OT 1100211,HI,,F,"face looked droopy on the left side;; itchy; felt like my face had been punched on the left side; A spontaneous report was received from a consumer concerning a 60-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pruritis, facial pain and facial paralysis. The patient's medical history, as provided by the reporter, included bell's palsy 20 years ago. Concomitant medications were not reported. On 03 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 03 Jan 2021, prior to receiving mRNA-1273, the patient felt itchy and like her face had been punched on the left side. On 06 Jan 2021 she felt her face looked droopy on the left side. Her dimple came back in her face. On 21 Jan 2021 her eyes was droopy and can see a line on one side, and other side doesn't have a line. It's gotten better with acupuncture. She gets acupuncture and electrostimulation; she had a horrible reaction to steroids. Her eye was stuck open for 3 months, she had a patch. Treatment for the events include 3 sessions of acupuncture. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, pruritis, facial pain and facial paralysis was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/03/2021,01/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Bell's palsy (20 years ago),,,"[""Bell's palsy"", 'Facial pain', 'Pruritus']",1,MODERNA,OT 1100213,KY,83.0,F,"knocked her out; uncontrollable shaking; terrible neck pain; terrible neck stiffness; pain down spine; sternum hurt; toes hurt; fingers hurt; overwhelming fatigue; chills; nausea; joint pain; body pain; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, and joint pain. The patient's medical history was not provided. Concomitant medications reported were Paxil, melatonin, red yeast rice supplement, fish oil, Hydrochlorothiazide for drug use for unknown indication. On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the events overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, joint pain. Treatment details included Tylenol and ibuprofen Action taken with mRNA-1273 in response to the events was not reported. At the time of reporting, the outcome of events include, overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, joint pain was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/28/2021,,,UNK,PAXIL [PAROXETINE HYDROCHLORIDE]; MELATONIN; FISH OIL; HYDROCHLOROTHIAZIDE,,Medical History/Concurrent Conditions: No adverse event,,,"['Arthralgia', 'Chest pain', 'Chills', 'Fatigue', 'Loss of consciousness', 'Musculoskeletal stiffness', 'Myalgia', 'Nausea', 'Neck pain', 'Pain in extremity', 'Spinal pain', 'Tremor']",1,MODERNA,OT 1100214,,,U,"really bad broken eye blood vessel; ice pick type headache, quite intense headache; A spontaneous report was received from a Consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events really bad broken eye blood vessel and quite intense ice pick type headache. The patient's medical history was not provided. No relevant concomitant medications were reported. On 14-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the events really bad broken eye blood vessel, quite intense headache, ice pick type headache. Treatment details were not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events include really bad broken eye blood vessel and quite intense ice pick type headache was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of headache, a causal relationship cannot be excluded. Very limited information regarding the eye hemorrhage has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Eye haemorrhage', 'Headache']",1,MODERNA,OT 1100215,NY,,M,"Erythema multiforme; A spontaneous report was received from a consumer concerning a 27-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced Erythema multiforme . The patient's medical history was not provided. No concomitant product use was reported. Family history included Steven Johnson syndrome (mother had a severe form). On 05 Feb 2021, the patient received his first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 15 Feb 2021, he noticed blistering on his arm, forearm and on his foot. He was diagnosed with Erythema multiforme (medically significant) following vaccination by his primary physician. Treatment included topical steroids. Action taken with mRNA-1273 with respect to the even Erythema multiforme was unknown. The outcome of the event Erythema multiforme was resolving at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/15/2021,10.0,UNK,,,Medical History/Concurrent Conditions: Stevens Johnson syndrome (mother had a severe form),,,['Erythema multiforme'],1,MODERNA,OT 1100218,CT,47.0,F,"Systemic allergic reaction; A spontaneous report was received from a Healthcare Professional concerning a 47 years old female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced the medically significant event of systemic allergic reaction/ hypersensitivity. The patient's medical history was not provided. Concomitant product use was not provided. On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch not provided) intramuscularly for prophylaxis of COVID-19 infection. On 09 Jan 2021, the patient experienced a systemic allergic reaction and ended up in the emergency room. On 10 Jan 2021, the patient experienced a new systemic reaction and she was back in emergency room. The patient was treated with epinephrine. No relevant laboratory details were included. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event systemic allergic reaction was considered resolved on 10 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,01/09/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,['Hypersensitivity'],1,MODERNA,OT 1100220,MD,79.0,M,"Complication from procedure; Could not get second dose as scheduled; A spontaneous report was received from a consumer concerning a 79-year-old male patient who experienced complication from surgery/ post procedural complication and could not get second dose as scheduled/ Inappropriate schedule of vaccine administered. The patient's medical history or concomitant medications were not provided. The patient received his first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly in the left dominant arm for prophylaxis of COVID-19 infection on 08 Jan 2021. On 08 Feb 2021 the patient underwent an outpatient surgical procedure. He could not get second dose as scheduled on 12 Feb 2021. On 18 Feb 2021, he was admitted to the hospital due to complication from procedure. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event could not get second dose as scheduled at the time of this report was resolved. The outcome of the event complication from procedure was unknown.; Reporter's Comments: This report refers to a case of a 79-year-old male patient who experienced a post surgical procedure complication after the first dose mRNA-1273 (lot #-unknown) and could not get second dose as scheduled (Inappropriate schedule of vaccine administered). There is limited information to assess the exact post surgical complication as the surgical and description of the complication was not provided.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/08/2021,,,UNK,,,Medical History/Concurrent Conditions: Surgery,,,"['Inappropriate schedule of product administration', 'Post procedural complication']",1,MODERNA,OT 1100222,CA,,U,"injection was below the ideal site for deltoid injection; A spontaneous report was sent by physician concerning a patient, unknown age or gender, who received Moderna' s COVID-19 vaccine (mRNA-1273) and experienced injection below the ideal site for deltoid injection. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. A physician reported that a patient received the vaccine injection below the ideal site for deltoid injection. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event was considered recovered.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history.),,,['Incorrect route of product administration'],1,MODERNA,OT 1100224,OK,,F,"Vaccination underdose; Some white liquid that was cold running down; A spontaneous report was received from other health care professional concerning a � 73Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event some white liquid that was cold running down/ Vaccination site discharge, Incorrect dose administered. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12-JAN-2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 22-FEB-2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly in the left deltoid. On 22-FEB-2021, The patient experienced some white liquid that was cold running down. Laboratory details were not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On 22-FEB-2021, the outcome of the event some white liquid that was cold running down was resolved.; Reporter's Comments: This report refers to a case of Vaccination site discharge and vaccination underdose for mRNA-1273, lot # 031L20A, with no associated AEs.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/12/2021,02/22/2021,41.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Incorrect dose administered', 'Underdose']",2,MODERNA,OT 1100226,LA,79.0,F,"they look like a beehive stung them; reaction is becoming systemic, because the patient now has a terrible itching everywhere, and they look like a beehive stung them; COVID arm; looks like bleeding under the skin; big area that was red and as big as the front part of her arm with a wider irregular shape, about a half inch crescent, dark subcutaneous reaction; as a severe allergic reaction; A spontaneous report was received from a consumer concerning a 79-year-old female who received the second dose of Moderna's COVID-19 (mRNA-1273) vaccine and experienced the following: covid arm (Vaccination site reaction), looks like bleeding under the skin (Vaccination site bruising), big area that was red and as big as the front part of her arm (Vaccination site erythema), the patient now has a terrible itching everywhere (Generalised pruritus), and they look like a beehive stung them (Generalized urticaria), and the reaction is becoming systemic, a severe allergic reaction (Allergy to vaccine). The patient's medical history was not provided. Concomitant product use included high blood pressure medication (not specified), curcumin, and acetylsalicyclic acid. On 07 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided). On 04 FEB 2021, approximately five days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly in the left deltoid for the prophylaxis of COVID-19 infection. On 08 Feb 2021, the patient experienced the events covid arm; mother of all covid arms; looked like hell, really bad; looked like bleeding under the skin; big area that was red and as big as the front part of arm with a wider irregular shape, about a half inch crescent, dark subcutaneous reaction; looked like bleeding under the skin; very tremendous reaction, but it does not hurt. On 11-Feb-2011, the red subcutaneous reaction deepened and started to migrate almost immediately, and slowly migrated 5-6 inches to the bottom of the arm near the elbow. The reporter stated the reaction seemed to be getting better; it was not getting any worse, but was worried it may turn into cellulitis or gangrene. On an unknown date, the patient consulted with a dermatologist for the ""Covid arm"" and the reporter stated that the reaction was becoming systemic because the patient now had terrible itching everywhere, and they looked like a beehive stung them. The reporter described it as a severe allergic reaction to the second vaccine dose with onset of this reaction 4-5 days after the second dose. Treatment for the events included some cream with steroids to treat the pruritus, as well as diphenhydramine. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Yes,Not Reported,,Not Reported,U,01/07/2021,02/08/2021,32.0,UNK,CURCUMIN; BABY ASPIRIN,,Medical History/Concurrent Conditions: No adverse event (No medical history provided),,,"['Allergy to vaccine', 'Pruritus', 'Urticaria', 'Vaccination site bruising', 'Vaccination site erythema', 'Vaccination site reaction']",1,MODERNA,OT 1100227,TN,84.0,F,"Lips and tongue stuck together due to dry mouth; feel like autoimmune disease flared up; Both arms were sore; The back of her head ached; upper back hurt; Felt wiped out; A Spontaneous report, was received from a consumer concerning a 84-year- old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine, and experienced fell like autoimmune flared up (autoimmune disorder), back of her head ached (headache), both arms were sore (limb discomfort), her upper back hurt (back pain), wiped out (fatigue) and extreme dry mouth. Patient's medical history included Sjogren's syndrome, Autoimmune thyroiditis. On 04 Feb 2021, the patient got the first dose of mRNA-1273 (Lot number: 016M20A) intramuscular upper arm location injection prophylaxis for COVID-19 infection. After 8 hours of receiving the first dose she felt like her autoimmune disease flared up, both of her arm were sored, the back of her head ached, her upper back hurt. She felt wiped out and went to bed much earlier than she normally does. The next day, her mouth was extremely dry, her lips and tongue was stuck together (due to the dry mouth). She did not take anything to alleviate the symptoms. She has not called her healthcare provider. Consent was given for safety to follow up. The action taken for fell like autoimmune flared up, back of her head ached, her upper back hurt ,extremely dry mouth, lips and tongue were struck together due to dry mouth and extreme dry mouth was unknown. The outcome for the events fell like autoimmune flared up, back of her head ached, her upper back hurt ,extremely dry mouth, lips and tongue were struck together due to dry mouth and extreme dry mouth was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (pain in extremity, headache, back pain, and fatigue), a causal relationship cannot be excluded. Very limited information regarding the event-Autoimmune disorder has been provided. The subject's history of Sjogren's syndrome may remain a risk factor for dry mouth. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/04/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Hashimoto's disease; Sjogren's syndrome,,,"['Autoimmune disorder', 'Back pain', 'Dry mouth', 'Fatigue', 'Headache', 'Pain in extremity']",1,MODERNA,OT 1100232,TX,64.0,F,"Fainted; Sweating; Vision was blurry; It went ""black; Whole skin feels cold; Felt something weird on her body; vision was sparkly; Chills; A spontaneous report was received from a Consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt something weird on her body, sweating, chills, vision was blurry, vision was sparkly, it went black, she fainted, whole skin feels cold, just feels weird. The patient's medical history was not provided. Products known to have been used by patient, with in two weeks prior to the event, included levothyroxine, lisinopril, amlodipine, omeprazole, atorvastatin, baby-aspirin, lisinopril hydrochlorothiazide. On 2-Jan-2021, patient received the first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly at right arm . On 28-Jan -2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly at right arm for prophylaxis of COVID-19 infection. On 21-Feb-2021, the patient experienced the events felt something weird on her body. sweating, chills, vision was blurry, vision was sparkly, it went black, she fainted, whole skin feels cold, just feels weird. Treatment information was not provided. The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable The outcome of events, felt something weird on her body, sweating, chills, vision was blurry, vision was sparkly, it went black, she fainted, whole skin feels cold, just feels weird were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/02/2021,02/21/2021,50.0,UNK,SYNTHROID; LISINOPRIL; AMLODIPINE; OMEPRAZOLE; ATORVASTATIN; BABY ASPIRIN; LISINOPRIL HCTZ,,Medical History/Concurrent Conditions: Blood pressure increased; Thyroiditis,,,"['Chills', 'Feeling abnormal', 'Hyperhidrosis', 'Peripheral coldness', 'Syncope', 'Vision blurred', 'Visual impairment']",1,MODERNA,OT 1100235,PA,,F,"Shingles; A spontaneous report was received from a healthcare professional concerning their patient, of unknown age, female patient who developed shingles/herpes zoster, open sores/ulcer. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on unknown date at the unknown injection site for prophylaxis of COVID-19 infection. The patient experienced shingles and open sores. Treatment of the events included Valtrex. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events shingles and open sores was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No relevant medical history),,,['Herpes zoster'],1,MODERNA,OT 1100238,WI,,U,"hospitalization; A spontaneous report was received from a health care professional concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hospitalization. The patient's medical history was not provided. Concomitant medications were not reported. On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient received the Moderna Covid-19 vaccine. The reporter provided a vaccination to the patient at a nursing home facility and per the dosing window, does not believe that the patient will be able to receive the second dose due to the patient being hospitalized. The patient was due to receive the second dose on 12 Mar 2021. No details on the patient's hospitalization were known or reported. Treatment for the events was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome events were unknown.; Reporter's Comments: Very limited information regarding the event of hospitalization has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/27/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (no medical history reported.),,,['Hospitalisation'],1,MODERNA,OT 1100239,NH,51.0,M,"Severe Allergic reaction; Heart attack; Neurological issues was unable to think straight; Extreme inflammatory response; A spontaneous report was received from a consumer and physician concerning a 51-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe allergic reaction, extreme inflammatory response, heart attack, neurological issues was unable to think straight. The patient's medical history was not reported by the reporter. Concomitant medication was not reported. On 22 Jan 2021, 15 minutes prior to the onset of the event, the patient received first of the two planned doses of mRNA-1273 (Lot number: unknown) through intramuscular route at right arm for prophylaxis of COVID-19 infection. On 22 Jan 2021, 15 minutes after the vaccination, patient had a severe allergic reaction. Patient had extreme inflammatory response, heart attack, neurological issues was unable to think straight, urinator catheter placed in on sight as fluid build and kept coming out, pulled out 1500ml. Patient was hospitalized 22 Jan 2021 through 24 Jan 2021. Laboratory information at the time of event was not provided. Treatment activities for event was unknown. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, severe allergic reaction, extreme inflammatory response, heart attack, neurological issues was unable to think straight was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,01/22/2021,01/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Hypersensitivity', 'Inflammation', 'Mental impairment', 'Myocardial infarction']",1,MODERNA,OT 1100240,MI,,F,"Intercranial hemorrhage/brain bleed; Chills; Fatigue; Really bad shortness of breath; A spontaneous report was received from a pharmacist regarding a 64-year-old female consumer, unknown race, and ethnicity, who experienced intracranial hemorrhage, chills, fatigue, and dyspnoea. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 22 Feb 2021, prior to the onset of symptoms, the patient received one of her two planned doses of mRNA-1273 vaccine intramuscularly for the prophylaxis of Covid-19 infection (Batch# 023M20A). On 22 Feb 2021, 7 hours post-vaccination, the patient developed symptoms of chills, fatigue, and a ""really bad"" shortness of breath with a pulse oximetry reading of 81% on room air. On 23 Feb 2021, the patient was hospitalzed and subsequently transferred to a sister hospital for an intracranial hemorrhage/brain bleed. Lab investigations and treatment details were not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, intracranial hemorrhage/brain bleed, chills, fatigue, and shortness of breath, was unknown at the time of the report.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.",Not Reported,,Yes,Yes,,Not Reported,U,02/22/2021,02/23/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Chills', 'Dyspnoea', 'Fatigue', 'Haemorrhage intracranial', 'Oxygen saturation']",1,MODERNA,OT 1100241,VA,,U,"Heart attack; A Spontaneous report was received from a pharmacy intern concerning a patient (age and gender unknown), who experienced a heart attack/myocardial infarction. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, prior to the onset of symptoms, the patient received one of their two planned doses (dose number not provided) of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, 8 days after vaccine administration, the patient experienced a heart attack. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of event, heart attack, was unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender with a serious unexpected event of myocardial infarction. The event occurred 8 days after first dose mRNA-1273. Treatment not reported. Event outcome unknown. Very limited information regarding this event has been provided at this time. Further information has been requested. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse reaction (No reported medical history.),,,['Myocardial infarction'],UNK,MODERNA, 1100242,FL,,M,"Pericarditis; Atrium flutter; Extremely anemic; Night sweats; A spontaneous report was received from a consumer concerning a male patient who experienced pericarditis, atrium flutter/atrial flutter, became extremely anemic/anaemia, and developed night sweats. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included sucralfate, mesalazine, metoprolol, escitalopram oxalate, colesevelam hydrochloride, multivitamin, vitamin D3, vitamin B 12 and fluocinonide. On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch# 029K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 8 Feb 2021, the same day as the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch# 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 08 Feb 2021, the patient presented to the emergency room with severe chest pain across his entire chest and entire jaw that was exacerbated when he took a breath. A pulmonary function test and electrocardiogram were performed (results not provided). The patient was admitted to the hospital with pericarditis and discharged 3 days later. Treatment included colchicine. In Feb 2021 (date not specified), the patient experienced night sweats and had a blood test (result not provided) that showed extreme anemia. The patient also developed atrial flutter. Treatment for atrial flutter included cardiac ablation and apixaban. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the event(s) is not applicable. The outcome of the events, pericarditis and atrium flutter, was considered not recovered. The outcome of the events, anemia and night sweats was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's medical history of taking colchicine can be contributory to the Anemia.",Not Reported,,Yes,Yes,,Not Reported,N,01/11/2021,02/01/2021,21.0,UNK,CARAFATE; PENTASA; METOPROLOL; LEXAPRO; TRAZODONE; MERCAPTOPURINE; WELCHOL; FAMOTIDINE; MULTIVITAMINS [VITAMINS NOS]; VITAMIN D3; B 12; FLUOCINONIDE,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Anaemia', 'Atrial flutter', 'Night sweats', 'Pericarditis']",2,MODERNA,OT 1100244,CA,62.0,F,"Bloody diarrhea; Loss of appetite; Skin on her back started to peel; Lower intestine is sore; Feeling queasy; chills; Fever of 101.1F that took about 3 days to break; Soreness at the injection site; Tired; A spontaneous report was received from a consumer concerning a 62 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feeling queasy, loss of appetite, nausea, lower intestine is sore, bloody diarrhea, fever of 101.1F that took about 3 days to break, skin on her back started to peel, soreness at the injection site and tired. The patient's medical history was not provided. No relevant concomitant medications were reported. On 10 FEB 2021 prior to the onset of the events, the patient received her second dose of two planned doses of mRNA-1273 (lot/batch:041L20A) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, the patient experienced the events feeling queasy, loss of appetite, nausea, lower intestine is sore, fever of 101.1F that took about 3 days to break, skin on her back started to peel, soreness at the injection site, tired and on unknown date event bloody diarrhea as medically significant serious criteria. Laboratory details were not provided. Treatment medication included Baby Aspirin. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events feeling queasy, loss of appetite, nausea, lower intestine is sore, bloody diarrhea, fever of 101.1F that took about 3 days to break, skin on her back started to peel, soreness at the injection site, tired was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Abdominal pain lower', 'Chills', 'Decreased appetite', 'Diarrhoea haemorrhagic', 'Fatigue', 'Nausea', 'Pyrexia', 'Skin exfoliation', 'Vaccination site pain']",2,MODERNA,OT 1100245,,,F,"Pleurisy; sharp, severe pain in the rib area under the arm where I had had the injection; Pressure in my lungs have risen, but not high enough to be medicated; Impossible to take a deep breath; Could barely communicate; Daytime oxygen levels were in the 88-89% level during the day.; A Spontaneous report was received from a consumer who was also a 70 year old , female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed sharp, severe pain in the rib area under the arm ""where I had had the injection""/ Musculoskeletal chest pain, impossible to take a deep breath/ Dyspnoea , could barely communicate/ Lack of spontaneous speech, pleurisy, daytime oxygen levels were in the 88-89% level during the day/ Oxygen saturation decreased, pressure in my lungs have risen, but not high enough to be medicated/ Pulmonary arterial pressure increased. The patient's medical history included bronchitis and supplemental oxygen at night. Concomitant product use was not provided by the reporter. On 05 Feb 2021, approximately two hours before the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 05 Feb 2021, approximately two hours after receiving the vaccine, the patient experienced sharp, severe pain in the rib area under the arm ""where I had had the injection""/ Musculoskeletal chest pain, impossible to take a deep breath/ Dyspnoea , could barely communicate/ Lack of spontaneous speech, pleurisy, daytime oxygen levels were in the 88-89% level during the day/ Oxygen saturation decreased two hours later. At the emergency room, blood tests, rib X-ray, and computerized tomography (CT) of the lungs were done. The CR scan showed some changes, which the radiologist said could be asthma or chronic bronchitis. The patient spent the next three weeks on supplemental oxygen during the day. On 23 Feb 2021, an echocardiogram indicated that pressure in her lungs have risen, but not high enough to be medicated/ Pulmonary arterial pressure increased. Treatment for the event was not reported. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event of developed sharp, severe pain in the rib area under the arm ""where I had had the injection""/ Musculoskeletal chest pain, impossible to take a deep breath/ Dyspnoea , could barely communicate/ Lack of spontaneous speech, pleurisy, ""pressure in my lungs have risen, but not high enough to be medicated""/ Pulmonary arterial pressure increased were not reported. The outcome of the event, daytime oxygen levels were in the 88-89% level during the day/ Oxygen saturation decreased, was considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: MOD-2021-029767:Patient's friend",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/05/2021,02/05/2021,0.0,UNK,,Oxygen therapy (At night),Medical History/Concurrent Conditions: Bronchitis,,,"['Computerised tomogram', 'Dyspnoea', 'Echocardiogram', 'Lack of spontaneous speech', 'Musculoskeletal chest pain', 'Oxygen saturation', 'Oxygen saturation decreased', 'Pleurisy', 'Pulmonary arterial pressure increased']",1,MODERNA,OT 1100246,,,F,"ear infection; A regulatory authority report was received from a consumer concerning a unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced ear infection. The patient's medical history, as provided by the reporter, included ear infection. Concomitant medications were not reported. On 25 Feb 2021, approximately one days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Feb 2021, prior to receiving mRNA-1273, the patient felt ear infection with medically significant. Treatment for the events included steroids shots. Action taken with mRNA-1273 in response to the events was not reported. The event, ear infection was considered unknown outcome event on 26 Feb 2021.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/25/2021,02/26/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Ear infection,,,['Ear infection'],1,MODERNA,OT 1100247,CA,78.0,F,"Unconsciousness; Feeling discomfort within a few minutes after the vaccination; A spontaneous report was received from a healthcare professional concerning a 78-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced of feeling discomfort within a few minutes after the vaccination, followed by unconsciousness and death. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, prior to the onset of the event, patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced feeling discomfort within a few minutes after the vaccination, followed by unconsciousness and death. Treatment information for event unconsciousness included resuscitate via cardiopulmonary resuscitation with no success. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event unconsciousness was fatal and patient died.; Reporter's Comments: This is a case of death of a 78-year-old, female patient who experienced within a few minutes of product use who experienced feeling of discomfort and became unconscious and subsequently expired. Based on the current available information, a strong temporal association between the product use and onset of the events, a causal relationship with the events cannot be excluded. However, critical details such as the patient's medical history and actual cause of death is lacking.; Reported Cause(s) of Death: Unknown cause of death",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No recorded medical history.),,,"['Discomfort', 'Loss of consciousness']",UNK,MODERNA,OT 1100248,NV,,F,"Major allergic reaction to the shot; Heat all over her body; Foggy head; Heavy right arm; Shooting pain under the breast; Left ear and face itching, itching spread all over body; Clogged ears; A spontaneous report was received from a 69-year old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced major allergic reaction to the shot, heat all over her body, foggy head, heavy right arm, shooting pain under the breast, left ear and face itching, itching spread all over body and clogged ears. The patient's medical history included asthma and anaphylactic shock with Sulfa medication. No relevant concomitant medications were reported. The patient received the first of two planned doses of mRNA-1273, (Lot/Batch No. 031M20A) on 26-Feb-2021 intramuscularly in the right arm for prophylaxis of COVID-19 infection. The patient reported after her first shot, she did stay in the office for 30 minutes and after she left within the hour after receiving the shot, she had a major allergic reaction. The patient felt heat all over her body, foggy head, right arm was heavy, shooting pain under breast, felt ear and face was itching. Then itching spread all over the body, and ears clogged up. As soon as itching spread, she took four Benadryl (diphenhydramine) 25mg each and used Dulera (mometasone-formoterol) asthma inhaler to prevent the reaction. She did not have a rash and did not have difficulty breathing because of the medicines that she took. The patient does not know if she can take the second shot because she fears having anaphylactic shock. Treatment for the events included Benadryl 25mg Capsules. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events major allergic reaction to the shot, I fear having anaphylactic shock, heat all over her body, foggy head, heavy right arm, shooting pain under the breast, left ear and face itching, itching spread all over body and clogged ears were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Yes,Not Reported,,Not Reported,U,02/26/2021,02/26/2021,0.0,UNK,,Asthma,Medical History/Concurrent Conditions: Anaphylactic shock (Anaphylactic shock with Sulfa medication),,,"['Chest pain', 'Dizziness', 'Hot flush', 'Hypersensitivity', 'Hypoacusis', 'Limb discomfort', 'Pruritus']",1,MODERNA,OT 1100249,IN,48.0,F,"Dizziness; Severe vertigo; Fell in yoga class; Lethargic; Feel run down; Nausea; A spontaneous report was received from other healthcare professional, concerning a 48 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced dizziness, severe vertigo (vertigo), fell in yoga class (fall), nausea, lethargic (lethargy), feel run down (depressed mood), and nausea. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03 Feb 2021, prior to the onset of events, the patient received the second of planned doses of mRNA-1273 (Batch number: 13M20A), intramuscularly in left arm for the prophylaxis of COVID-19 infection. On 03 Feb 2021, same day, the patient experienced nausea, dizziness, severe vertigo, having a fall in yoga class, lethargy, & feels run down. The patient went to urgent care, and then the emergency room (ER). An electrocardiogram (EKG) and a computerised tomography (CT) scan were done with no results provided. The patient was given ondansetron and meclizine. Action taken with second dose of mRNA-1273 in response to the events was not applicable. The outcome of the events, dizziness, severe vertigo, fell in yoga class, nausea, lethargic, feel run down, and nausea were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Depressed mood', 'Dizziness', 'Fall', 'Lethargy', 'Nausea', 'Vertigo']",2,MODERNA,OT 1100250,TX,,F,"Had a fall; The lower part of her body was without feeling; There was a lot of damage to the nerves; A spontaneous report was received from a consumer for a 75-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was hospitalized as she had a fall and the lower part of her body was without feeling, and there was a lot damage to the nerves. The patient's medical history included a back surgery. No concomitant product use was reported. On 15 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 042L20A) intramuscularly for prophylaxis of COVID-19 infection. 02 Feb 2021, approximately 17 days after receiving the vaccine, she had been hospitalized as had a fall and the lower part of her body was without feeling. She had previous back surgery, so there was a lot damage to the nerves and she was still presently in rehab. She could not receive her second dose because of hospitalization. The treatment medication was not reported. Action taken with mRNA-1273 with respect to the events was not reported. The outcome of the event(s) for which she had a fall and the lower part of her body was without feeling, and there was a lot damage to the nerves were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/15/2021,02/02/2021,18.0,UNK,,,Medical History/Concurrent Conditions: Back surgery,,,"['Fall', 'Hypoaesthesia', 'Nerve injury']",1,MODERNA,OT 1100251,FL,,F,"FELL; panctured lung; Broken ribs; small complication; diagnosed with covid19; A spontaneous report received from a Consumer concerning, 95-year-old age female patient who received first dose of the Moderna COVID-19 vaccine and experienced falling, punctured lung, broken ribs and diagnosed with COVID-19 on 05FEB2021. The patient's medical history was not included. Patient's concomitant was not included. On 06JAN2021 date, the patient received their first dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Patient daughter-in-law stated that the patient received her first Moderna COVID-19 vaccine on 06JAN2021. Patient daughter-in -law stated that the patient fell the next day and punctured her lung, broke her ribs, and had small complication (unspecified). Patient daughter-in-law stated that the patient was moved to a rehab facility after hospitalization. Patient daughter-in-law stated that the patient was diagnosed with COVID-19 on 05FEB2021. Consent was provided for follow up from safety. Treatment information was not provided/ unknown Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was unknown/ not reported.; Reporter's Comments: The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/06/2021,02/05/2019,,UNK,,,Medical History/Concurrent Conditions: No adverse event (no medical history reported.),,,"['Adverse event', 'COVID-19', 'Fall', 'Multiple fractures', 'SARS-CoV-2 test', 'Traumatic lung injury']",1,MODERNA,OT 1100252,IA,87.0,M,"Atrial fibrillation ""AFib"" - Heart Rate of 150 BPM; A spontaneous report was received from an 87-year-old male patient, who experienced Atrial fibrillation - Heart Rate of 150 BPM. The patient's medical history included Atrial fibrillation (Afib). Relevant concomitant medication included amiodarone. The consumer received the first of the two planned doses of mRNA-1273 on 03-FEB-2021 intramuscularly for prophylaxis of COVID-19 infection. On the same day, he experienced Atrial fibrillation - Heart Rate of 150 BPM. No treatment information was provided. On 04-MAR-2021, the patient received the second of the two planned doses of the mRNA-1273 in an unknown route. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event Atrial fibrillation ""AFib"" - Heart Rate of 150 BPM was resolved. The report's causality assessment was not provided for the event. Follow-up received on 05-MAR-2021 included Atrial fibrillation (Afib) as the consumer's historical condition. Consumer reported that he was in Afib for about 9 days. Doctors changed some of his medications that has helped with his condition. Consumer had his second dose of the vaccine on 04-MAR-2021 and has had no issues with AFib.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/03/2021,02/03/2021,0.0,UNK,AMIODARONE,,Medical History/Concurrent Conditions: Atrial fibrillation,,,['Atrial fibrillation'],2,MODERNA,OT 1100255,FL,,F,"out of sorts; dry heaving; so dizzy couldn't see; sweating to death; so dizzy couldn't see; A spontaneous report was received from a consumer who was a 76-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced sweating to death, so dizzy could not see, dry heaving, blood pressure was 127/108 and out of sorts. The patient's medical history included stroke and hypertension. Concomitant products included hydrazine and meclizine. On 01-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly for prophylaxis of COVID-19 infection. On 01-Mar-2021, the same day of vaccine administration, the patient experienced sweating to death and so dizzy that she could not see. Her husband took her to the emergency room on 02-Mar-2021 and on the way, she was dry heaving. Her blood pressure at the hospital was 127/108. She stayed in the emergency room for 12 hours and took blood pressure medication hydrazine and Meclizine, which helped. On 03-Mar2021, she reported that she was still out of sorts and lightheaded. Treatment information for the events was not reported. Action taken with mRNA-1273 with respect to the events was not reported. The outcomes of the events, sweating to death, so dizzy could not see, dry heaving, blood pressure was 127/108 and out of sorts, were considered unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded. Patient has a history of stroke and hypertension.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/01/2021,03/01/2021,0.0,UNK,HYDRALAZINE; MECLIZINE [MECLOZINE],Hypertension,Medical History/Concurrent Conditions: Stroke,,,"['Blindness transient', 'Blood pressure measurement', 'Dizziness', 'Feeling abnormal', 'Hyperhidrosis', 'Retching']",1,MODERNA,OT 1100256,FL,,M,"Bells Palsy; A spontaneous report was received from a pharmacist concerning a 73-year-old male patient who developed Bells palsy. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin and metoprolol. On 01 Mar 2021, prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. In Mar 2021 (date not specified), the patient developed Bells palsy, and was subsequentlyadmitted to the emergency room/hospital. Treatment included intravenous fluids. Action taken with mRNA-1273 was not provided. The outcome of the event, bell's palsy, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,03/01/2021,,,UNK,ATORVASTATIN; METOPROLOL,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"[""Bell's palsy""]",1,MODERNA,OT 1100257,FL,70.0,M,"23 days after receiving the vaccine was hospitalized because of an urosepsis; A spontaneous report was received from a other healthcare professional concerning a 70-year-old male patient experienced urosepsis 23 days after receiving the vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received the first of the two planned doses of mRNA-1273 on 01-FEB-2021 in unknown arm (Batch: 004M20A) intramuscularly for prophylaxis of COVID-19 infection. On 03-MAR-2021, 23 days after receiving the vaccine was hospitalized because of an urosepsis. No treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event was unknown. The assessment was not provided for the event.; Reporter's Comments: The event was consistent with increased risk of complications associated with elderly age of patient. Company assessed the event to be unlikely related to company product.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/01/2021,03/03/2021,30.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Urosepsis'],1,MODERNA,OT 1100258,TX,52.0,M,"Bells Palsy; he lost strength in his left face, arm, and leg; Felt nauseous; couldn't breathe; burning sensation from the left side of face from temple to neck; Localized muscle weakness; A spontaneous report was received from a health care professional concerning a 52-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed bell's palsy, nausea, dyspnea, burning sensation in face and localized muscle weakness. The patient's medical history included covid-19 . Products known to have been used by the patient, within two weeks prior to the event, not provided. On 25 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 25 Jan 2021, the patient felt nauseous and couldn't breathe. The feeling went away so he did not think too much of it. 30 minutes after that, he lost strength in his left face, arm, and leg and diagnosed with Bells Palsy. There was a burning sensation from the left side of his face from the temple to the neck. Treatment for the event was not reported. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event's,reported, was considered not recovered..; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/25/2021,0.0,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"[""Bell's palsy"", 'Burning sensation', 'Dyspnoea', 'Hemiparesis', 'Muscular weakness', 'Nausea']",2,MODERNA,OT 1100259,WA,66.0,M,"Kidney Stones/pyelonephritis; Severe Pain; Couldn't Stand; Difficulty Breathing; Joint Pain; Severe Fever 102.9; A spontaneous report was received from a consumer who was also a 66-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced with kidney stones or pyelonephritis/ nephrolithiasis, severe fever 102.9/ pyrexia, severe pain/ pain, couldn't stand/ dysstasia, joint pain/ arthralgia and difficulty breathing/ dyspnoea. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 13 Feb 2021, morning at 2-3am patient had a severe fever of 102.9 and joint pain. Later patient developed severe pain and couldn't stand up. On same patient went to emergency room and was diagnosed with pyelonephritis (kidney stones). Patient also reported that patient was having a difficult time breathing. Treatment for the event included receiving oxygen. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/12/2021,02/13/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Arthralgia', 'Dyspnoea', 'Dysstasia', 'Nephrolithiasis', 'Pain', 'Pyrexia']",1,MODERNA,OT 1100260,AZ,38.0,F,"back pain; difficulty breathing; heart racing; heart hurting; felt like she would pass out; A spontaneous report was received from a consumer who was also a 38-years-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced heart racing (palpitations), heart hurting (angina pectoris), difficulty breathing (dyspnea), felt like she would pass out (presyncope) and back pain. The patient's medical history was not provided. Concomitant product use was not provided. On 22 Jan 2021, the patient received the first of two planned doses of mRNA-1273 on (Batch# 043L20A) (route of administration unknown) for prophylaxis of COVID-19 infection. On 22 Jan 2021, after three weeks post vaccination, the patient reported still having symptoms of her heart racing and hurting, difficulty breathing, felt as if she was going to pass out, and about a week of back pain. On 12 Feb 2021, the patient went to the emergency room (ER) for heart symptoms. She reported everything was fine at the ER. The patient was to have second dose on 16 Feb 2021 and inquired on whether to have the second dose if experiencing all of these symptoms. No treatment information was provided.. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Angina pectoris', 'Back pain', 'Dyspnoea', 'Palpitations', 'Presyncope']",1,MODERNA,OT 1100261,OH,,M,"Pain in arm; Loss of range of motion in arm; Injected into bursa space in the shoulder joint; A spontaneous report was received from a consumer concerning a 44 year old, male patient who experienced pain in the arm, loss of range of motion in the arm and incorrect route of administration. The patient's medical history was not provided. Concomitant medication was not provided. The patient received their first of two planned doses of mRNA-1273 (Batch: 025J20A) on 31 DEC 2020. On 02 FEB 2021, approximately the same day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch : 026L20A) and was injected into bursa space in the shoulder joint for prophylaxis of COVID-19 infection. On 02 Feb 2021, the patient experienced severe pain in the arm and loss of range of motion in the arm. The patient was hospitalized on 03 FEB 2021 and released on 04 FEB 2021. Treatment information was not provided. Action taken with vaccine was not applicable.. The outcome for pain in the arm, loss of range of motion in the arm was not reported and recovered for incorrect route of administration.; Reporter's Comments: This report refers to a case of Vaccine administration error for mRNA-1273, lot # 026L20A with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,12/31/2020,02/02/2021,33.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Incorrect route of product administration', 'Pain in extremity', 'Vaccination site movement impairment']",1,MODERNA,OT 1100262,NC,,F,"Kidney stone; patient was also treated for sepsisduring her admission; This spontaneous report from was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was found to have a kidney stone and was treated for sepsis. The patient was diagnosed with urinary tract infection (UTI) before receiving the first dose of the vaccine. Products known to have been used by patient, within two weeks prior to the event, included antibiotics. On 08-Feb-2021 the patient received her first dose of mRNA-1273 (Lot number: 011M20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection. The patient continued having the UTI after receiving the first dose and was started on antibiotics. The patient was found to have a kidney stone and was admitted to the hospital for kidney stone removal surgery on 24-Feb- 2021. Patient was also treated for sepsis during her admission at the hospital. Patient was scheduled for second dose on 08-Mar-2021 and would like to know if it was okay for her to receive the second dose. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events kidney stones and sepsis were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/08/2021,,,UNK,ANTIBIOTICS,"Urinary tract infection (the patient was diagnosed with Urinary Tract Infection (UTI) before receiving the first dose, and continued having the UTI after receiving the first dose and was started on antibiotics.)",,,,"['Nephrolithiasis', 'Sepsis']",1,MODERNA,OT 1100263,AZ,73.0,F,"autoimmune hepatitis is triggered; autoimmune hepatitis is triggered/might have triggered the reactivation of the autoimmune hepatitis; liver enzyme are way out of site, very high; welt; palm size red hot on my arm but way below the shot/Kind of hot and itchy; palm size red hot on my arm but way below the shot/Kind of hot and itchy; palm size red hot on my arm but way below the shot/Kind of hot and itchy; A spontaneous report was received from a consumer concerning a 73 year old, female patient who experienced good palm size red hot on her arm but way below the shot, hotness itched, 10 days after vaccine welt returned, liver enzyme way out of site, very high. Doctors say that autoimmune hepatitis is triggered. The patient's medical history was autoimmune diseases and had autoimmune hepatitis in the past, 2017 last one. Concomitant product use Estratest, Gabapentin, Omeprazole, Zinc, B50, CoQ10, Coconut oil, and Magnesium. The patient received their first of two planned doses of mRNA-1273 Batch number [(0 o6)31L20A] on 12Feb2021, intramuscularly in the arm for prophylaxis of COVID-19 infection. The patient stated she had a reaction to first Moderna vaccine shot and I didn't think it was too bad but she had autoimmune diseases and had autoimmune hepatitis in the past, 2017 last one. On 14Feb2021, second day after vaccine she got a good palm size red hot on her arm but way below the shot. Where shot admin it looked okay. Kind of hot itchy and that lasted one and a half day. Tenth day after vaccine shot this welt came back again and lasted a couple of days.So then when she went to have blood test on Tuesday and mentioned lady taking blood that this red area and told her what happened, and asked her if she had seen this happen and lady mentioned that no. And now she is concerned because she had her blood report back last night, and her liver enzyme are way out of site, very high. Doctors said that autoimmune hepatitis is triggered. Phone with liver doctor. We don't know yet, they suspect that vaccine as autoimmune system is supposed to attack Covid, in fact it might have triggered the reactivation of the autoimmune hepatitis. Treatment for the event none provided. The outcome of the events were not resolved. Action taken with mRNA-1273 in response to the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (vaccination site pain) a causal relationship cannot be excluded. However, a very limited information has been provided for the events-Autoimmune hepatitis, condition aggravated, and hepatic enzyme increased, at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/14/2021,2.0,UNK,ESTRATEST; GABAPENTIN; OMEPRAZOLE; ZINC; B50; COQ10 COMPLEX; COCONUT OIL; MAGNESIUM,,"Medical History/Concurrent Conditions: Autoimmune disorder (Patient reported autoimmune diseases and had autoimmune hepatitis in the past, 2017 last one.); Autoimmune hepatitis (Patient reported autoimmune diseases and had autoimmune hepatitis in the past, 2017 last one.)",,,"['Autoimmune hepatitis', 'Condition aggravated', 'Hepatic enzyme increased', 'Urticaria', 'Vaccination site erythema', 'Vaccination site pruritus', 'Vaccination site warmth']",1,MODERNA,OT 1100264,,,F,"passed out on the floor; fainted; A spontaneous report was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who fainted and passed out on the floor. The patient's medical history was not provided. Concomitant medications included a blood pressure pill and a thyroid pill. On 23 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. The details of the administration of the first dose were not provided. On 24-Feb-2021, after being awake for 30 minutes, the patient passed out on the floor and fainted. Treatment information was unknown. Action taken with study drug was not applicable as the patient had already received both scheduled doses. The outcome of the events, fainting and passed out on the floor, was resolved on 24 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/24/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Loss of consciousness', 'Syncope']",1,MODERNA,OT 1100265,,,F,"Thrombocytopenia; A spontaneous report was received from a nurse concerning, an unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed medically significant event of thrombocytopenia. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On unknown date, prior to the onset of event, the patient received the first dose of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, after receiving vaccine, the patient developed thrombocytopenia. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event of thrombocytopenia, was not provided.; Reporter's Comments: Based on the very limited information provided on the use of the product and the onset of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No relevant medical history),,,['Thrombocytopenia'],UNK,MODERNA,OT 1100266,MS,,F,"kidney infection; cysts on her kidney; she was down and in the bed feeling bad; A spontaneous report was received from a consumer concerning a 51 year old, female patient who developed feeling bad, kidney infection and renal cysts. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 08-JAN-2021, approximately 2 days prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. The patient was not feeling great after receiving the vaccine and was in bed. On 10-JAN-2021, the patient went to the hospital and was admitted for 4 nights, 3 days for a kidney infection. Cysts on the patient's kidneys were found. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the event(s) were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/08/2021,01/08/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Feeling abnormal', 'Kidney infection', 'Renal cyst']",1,MODERNA,OT 1100267,,,F,"chills; fatigue; heat from head; sweating; Passed out; A spontaneous report was received from a 51- year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced heat from head, sweating, passing out, chills and fatigue. The patient's medical history was not provided. No concomitant product use was reported. On 03-Mar-2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 001211a) intramuscularly for prophylaxis of COVID-19 infection. On 03-Mar-2021, 4.5 hours after the administration of the vaccine the felt heat from head and was sweating following which the patient passed out. On 04-Mar-2021, it was reported the patient was feeling better despite of experiencing chills and fatigue. Treatment information was not provided. Action taken with mRNA-1273 was unknown. The outcome of the events was unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/03/2021,03/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Chills', 'Fatigue', 'Feeling hot', 'Hyperhidrosis', 'Loss of consciousness']",1,MODERNA,OT 1100268,PA,64.0,F,"Headache; extreme fatigue to the point that she could not walk; extreme fatigue to the point that she could not walk; A spontaneous report was received from a Consumer concerning a 64 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Headache, Fatigue and Gait inability. The patient's medical history was not provided. Relevant concomitant medication was not reported. On 07 Jan 2021, the patient received their first dose of two planned dose of mRNA-1273 (lot/batch: 012L20A) intramuscularly for prophylaxis of COVID-19 infection. After first dose the patient did not experience any adverse event. On 04 Feb 2021, prior to the onset of event, the patient received their second dose of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, the patient experienced Headache then extreme Fatigue and Gait inability. Due to these events the patient was hospitalized. Laboratory details was provided as the physician did some laboratory test, but result was normal. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. At the time of this report, the outcome of the events, Headache, Fatigue and Gait inability, was considered as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/07/2021,02/18/2021,42.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Fatigue', 'Gait inability', 'Headache']",1,MODERNA, 1100269,FL,,M,"acute pancreatitis; Pneumonia; edema; fever; fatigue; nausea; bloating; Major bowel movement; loss of appetite; muscle pain; A spontaneous report was received from a unknown years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue (Fatigue), fever (Pyrexia), bloating (Abdominal distension), major bowel movement (Bowel movement irregularity), pneumonia (Pneumonia), loss of appetite (Decreased appetite), acute pancreatitis (Pancreatitic acute), edema (Oedema), muscle pain (Myalgia) and nausea (Nausea). The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin calcium, ramipril, metoprolol succinate, acetylsalicyclic acid and fish oil. On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number: 12L20A) through intramuscularly route of administration in the right upper arm for prophylaxis of COVID-19 infection. On 19 Jan 2021, approximately eight days after the vaccine, patient started experiencing muscle pain, major bowel movements, loss of appetite, bloating and nausea. On 26 Jan 2021,t he patient was hospitalized due to fatigue, fever and some GI issues. Patient was diagnosed with acute pancreatitis, pneumonia, and some edema. Patient said he was tested for COVID-19 multiple time at the hospital and all came back negative. Patient was given some antibiotics and Eliquis for treatment. On 08 Feb 2021, the patient received their second of two planned doses of mRNA (Lot number:013L20A) intramuscularly for prophylaxis of COVID-19 infection. He did not report any symptom on his second dose. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events were unknown.; Reporter's Comments: The events were consistent with increased risk associated with pancreatitis which was consistent with pancreatic inflammation with unknown etiology. Company assessed the events to be unlikely related to company product.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/11/2021,01/19/2021,8.0,UNK,LIPITOR; RAMIPRIL; METOPROLOL SUCCINATE; ASPIRIN [ACETYLSALICYLIC ACID]; FISH OIL,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Abdominal distension', 'Bowel movement irregularity', 'Decreased appetite', 'Fatigue', 'Myalgia', 'Nausea', 'Oedema', 'Pancreatitis acute', 'Pneumonia', 'Pyrexia', 'SARS-CoV-2 test']",2,MODERNA,OT 1100270,PA,25.0,F,"pounding heart, heart rate increased; panic; Total body flushing; Sensation of hot and cold; Shaking; lightheadedness; feelings of passing out; nausea; arm numbness; extremity tingling; headache; exhaustion; fever; fluctuating blood pressure; racing heart ,heart palpitations; mild flushing; brain fog; A spontaneous report was received from a healthcare professional concerning a 25-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced panic, rapid pulse, pounding heart, total body flushing, shaking, a sensation of hot and cold, lightheadedness, and feelings of passing out, nausea, extremity tingling, and arm numbness, headache, brain fog, racing heart, heart palpitations, fluctuating blood pressure, mild flushing, exhaustion, and fever. The patient's medical history, was not provided by the reporter, but patient had a tuberculosis test done in recent days prior to vaccination, reports were not provided. Concomitant medications reported included vitamin B-12 complex and ibuprofen. On 04-Mar-2021 at 5:55 pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013A21A) intramuscularly in the deltoid for prophylaxis of COVID-19 infection. On 04 Mar 2021, approximately after 23 minutes after receiving the vaccine patient developed panic, rapid pulse, pounding heart, total body flushing, shaking, a sensation of hot and cold, lightheadedness, and feelings of passing out. Patient pulled over and called 9-1-1, and she was taken by ambulance to a nearby hospital. Patient had reported that the symptoms persisted during ambulance transit and continued during her three hour hospital stay. Patient reported to have development of nausea, extremity tingling, and arm numbness while being admitted. Patient reported that a friend of her drove her home from the hospital, and her brother was monitoring her condition. No medicinal treatments were administered at the hospital for the patient. On 05 Mar 2021, Patient took advil to treat the headache and brain fog that has developed. Patient reported that the symptoms headache, brain fog, racing heart, heart palpitations, fluctuating blood pressure, mild flushing, exhaustion, and fever were continuing. As treatment for events no medicinal treatments were administered at the hospital. Patient reported that she had taken ibuprofen to treat a headache and brain fog. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, panic, rapid pulse, pounding heart, total body flushing, shaking, a sensation of hot and cold, lightheadedness, and feelings of passing out, nausea, extremity tingling, and arm numbness was unknown and headache, brain fog, racing heart, heart palpitations, fluctuating blood pressure, mild flushing, exhaustion, and fever were not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,03/04/2021,03/04/2021,0.0,UNK,VITAMIN B 12 [CYANOCOBALAMIN] complex; ADVIL [IBUPROFEN],,Medical History/Concurrent Conditions: No adverse event (Medical history not provided),,,"['Blood pressure fluctuation', 'Depressed level of consciousness', 'Dizziness', 'Fatigue', 'Feeling of body temperature change', 'Flushing', 'Headache', 'Heart rate increased', 'Hypoaesthesia', 'Loss of consciousness', 'Nausea', 'Palpitations', 'Panic reaction', 'Paraesthesia', 'Pyrexia', 'Tremor']",1,MODERNA,OT 1100271,WI,82.0,F,"Lost control of muscles; ended up blacking out; could not move; could not talk; A spontaneous report was received from a Consumer concerning about a 82 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Paralysis, Syncope, Mobility decreased and Aphasia. The patient's medical history was provided as diabetes, dementia as current illness. Relevant concomitant medication was reported as blood thinner for blood clots. On 08 FEB 2021, prior to the onset of event, the patient received their first dose of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 10 FEB 2021, the patient experienced Paralysis, Syncope, Mobility decreased and Aphasia. Due to these events patient's required hospitalization and on oxygen. Laboratory details was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event's Paralysis, Syncope, Mobility decreased, and Aphasia was as unknown.; Reporter's Comments: The events were consistent with increased risk of cerebrovascular complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/08/2021,02/10/2021,2.0,UNK,,Dementia (Patient has dementia.); Diabetes (Patient has diabetes.),,,,"['Aphasia', 'Mobility decreased', 'Paralysis', 'Syncope']",1,MODERNA,OT 1100272,NC,,F,"Stroke; A spontaneous report was received from a consumer who was also a 76-years-old female patient, who received Moderna's covid-19 vaccine (mRNA-1273) and who experienced stroke (stroke). The patient's medical history was not provided. Concomitant medications were not reported. On 13 FEB 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route for prophylaxis of COVID-19 infection. On 23 FEB 2021, the patient had a stroke leading to hospitalization. Treatment details were not provided. Action taken with mRNA-1273 in response to the events was unknown. At the time of this report, the outcome of the event stroke was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/13/2021,02/23/2021,10.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No recorded medical history.),,,['Cerebrovascular accident'],1,MODERNA,OT 1100273,,,M,"Her fiance who has been tested positive; Her fiance who has been tested positive; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 31Jan2021 this case now contains all required information to be considered valid: This is a spontaneous report from a non-contactable consumer (Patient's fiance) and a contactable consumer (Patient). An elderly male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 18Dec2020 at single dose, second dose via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunisation. Medical history included back pain before receiving the vaccine; later described as a Spinal pain. The patient's concomitant medications were not reported. Caller said she got the 1st dose of Covid vaccine on the 18Dec. But she is living with her fiance who has been tested positive. Caller would like to know if there is any reason why she should take the 2nd dose of the vaccine. Caller stated receiving the first dose of the COVID-19 vaccine yesterday (18Dec2020), And receiving a drug prescription for ""Medol"" today. He explained that his appointment with the doctor was scheduled a month ago, due to his ""back pain"", which he later described as a ""Spinal pain"". He specified that ""everything is fine"" and that his pain is not due to the inoculation. He asked if the Medol would interact with the vaccine. patients second dose was scheduled for Wednesday and he got a call on Saturday saying the spot was not available now. They want me to get his second dose tomorrow instead. he had heart problems and he was over 65 years old. he was thinking perhaps he should wait because he wanted the maximum beneficial effect of the inoculation. Will he get as much protection if he got the vaccine at 19 days instead of 21 days, patient questioned. Reporter said (patients fiance) she got the 1st dose of Covid vaccine on the 18Dec2020. But she was living with her fiance who had been tested positive. Caller would like to know if there is any reason why she should take the 2nd dose of the vaccine she questioned. The relevant laboratory tests includes SARS-CoV-2 Antibody test with result was positive. Outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/13/2021,,,UNK,,,"Medical History/Concurrent Conditions: Back pain (before receiving the vaccine; later described as a ""Spinal pain); Heart disorder; Spinal pain",,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 antibody test']",2,PFIZER\BIONTECH, 1100278,NC,,F,"she tested positive for ""antibodies""; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), the first dose via an unspecified route of administration on 30Dec2020 (lot number and expiry date were not reported) at a single dose; and the second dose via an unspecified route of administration on 20Jan2021 (lot number and expiry date were not reported) at a single dose, both for COVID-19 immunization. Medical history and concomitant medications were not reported. The nurse reported that she is part of a study and donated blood for research. Her blood sample was sent on Monday, 25Jan2021. She later found out that she tested positive for ""antibodies"" and may have been exposed to the virus. She stated that she is ""totally asymptomatic"". She received the first dose of the vaccine last 30Dec2020 and the second dose last 20Jan2021. She called to seek information regarding the vaccine efficacy given this finding. Outcome of the event was unknown. The nurse assessed the event as non-serious. Information about Lot and Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,01/25/2021,5.0,UNK,,,,,,"['SARS-CoV-2 antibody test', 'SARS-CoV-2 antibody test positive']",2,PFIZER\BIONTECH, 1100305,NY,58.0,F,"She had symptoms of shingles last Sunday; She noticed burning and tingling on the left side of her head; She noticed burning and tingling on the left side of her head; Shingles was reported as worsened; This is a spontaneous report from a contactable consumer (patient herself) via Medical information team. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0140) via unknown route of administration on 12Jan2021 14:00 PM at single dose in left arm for COVID-19 immunization at nursing home. Medical history included ongoing high blood pressure. Ongoing concomitant medication included metoprolol orally at 50 mg, once a day taking for 10 years and hydrochlorothiazide orally at 25 mg, once a day taking for 3 years both for high blood pressure, mecobalamin (B12) orally at 1000 ug, once a day taking 6 years for low b, colecalciferol (D3) orally at 100 ug, daily (50mcg; take two daily by mouth) taking for 6 years for low d. Patient received the first dose of the Pfizer covid vaccine on 12Jan2021 and her second dose was scheduled 02Feb2021. She had symptoms of shingles last Sunday on 29Jan2021 and was given famciclovir and was advised to not take the scheduled second dose of the vaccine. The next time that the vaccine will be given in their facility is on 22Feb2021-23Feb2021, and she wants to know if she can get the vaccine despite having shingles. However she came down with shingles. Adds she is being treated with Famciclovir 50mg; take three times daily by mouth. Her doctor recommended she not get the next dose of the Pfizer COVID 19 vaccine on 02Feb2021 so she stayed home and did not get it. Should she get the second dose? She noticed burning and tingling on the left side of her head in Jan2021 and then shingles on 29Jan2021 on the left eyebrow and hairline. Also shingles was reported as worsened in 2021. Adverse events required a visit to physician or ER was reported as Urgent care but not to the hospital. No Prior Vaccinations (within 4 weeks). The outcome of events shingles and condition worsened was not recovered, while for other events was unknown. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/12/2021,01/01/2021,,SEN,METOPROLOL; HYDROCHLOROTHIAZIDE; B12 [MECOBALAMIN]; D3,Blood pressure high,,,,"['Burning sensation', 'Condition aggravated', 'Herpes zoster', 'Paraesthesia']",1,PFIZER\BIONTECH, 1100306,NC,,M,"funny feeling; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer (patient himself) reported that an unspecified aged male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medication were not reported. Patient said that he received his first dose on the 20th Jan and said about 40 mins after his first dose he took two ibuprofen and he took another two ibuprofen 4 hours later. Patient received the first dose of the COVID vaccine. 40 minutes after, he took 1 Advil to avoid feeling any reactions. However, due to a 'funny feeling' he took 2 more in the afternoon. He felt fine afterwards. He stated having multiple 'risk factors'. Outcome of event was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,,,UNK,,,,,,['Feeling abnormal'],1,PFIZER\BIONTECH, 1100315,FL,,F,"headache on my left side where I got my shot; painful chest pressure/burning and pressure in chest; painful chest pressure/burning and pressure in chest; tested Covid positive; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9263 and expiration date: unknown), via an unspecified route of administration on the left arm on 27Jan2021 at a single dose for COVID-19 immunization. Medical history included reflux diagnosed about 6 years ago, cholesterol and osteoporosis. Concomitant medications included alendronate sodium (ALENDRONATE) for Osteoporosis-the doctor told her to stop this one because it may contribute to heart problems, atorvastatin (ATORVASTATIN) for Cholesterol-taking probably 2-3 years, and omeprazole (OMEPRAZOLE) for reflux, which the patient has been taking about 6 years. The patient received her first Pfizer vaccine dose and had some symptoms right after- burning and pressure in chest, states they kept longer than 15 minutes about 30 minutes, then she went home. She developed painful chest pressure and a headache on the left side where she got her shot. The patient went to the ER and was admitted for 2 days. She then tested positive for Covid and was upset because she was reportedly careful. The doctors wanted to do a heart catheterization to check for blockage and she refused. States they gave her high blood pressure medication, metoprolol, in the hospital but her primary care told her to stop taking it because she doesn't have high blood pressure. States she also takes vitamins including vitamin d3, Caltrate 600+D3, and CoQ10 200mg, and just started taking a baby aspirin in the morning. She also had a headache the whole time in Jan2021, that resolved a couple of days ago. She was released (discharged) on 29Jan2021, and is to follow up with a cardiologist, but they will not see her until she is negative for Covid 19. She spoke to her PCP and she will be out of quarantine on 08Feb2021. She was supposed to get a phone call or text from the vaccination location about scheduling her second vaccine dose. She was also asking if she can delay the second immunization shot until she gets her cardiology issues resolved. The event ""headache on my left side where I got my shot"" resolved in Feb2021, and the event ""painful chest pressure/burning and pressure in chest"" had not resolved, while the outcome of the rest of the events was unknown.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,01/27/2021,01/01/2021,,UNK,ALENDRONATE; ATORVASTATIN; OMEPRAZOLE,,Medical History/Concurrent Conditions: Cholesterol total abnormal NOS; Osteoporosis; Reflux gastritis (diagnosed about 6 years ago),,,"['Burning sensation', 'Chest discomfort', 'Headache', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1100322,IL,48.0,F,"pins & needles tingling; hot/cold flashes; temp/fever; chills; Headache; body aches; dry mouth; sore R arm; LOSS OF TASTE; partial throat swelling 90 min after 2nd injection; drowsy; This is a spontaneous report from a contactable health care professional. A 48-years-old female received 2nd dose, bnt162b2 (BNT162B2) Lot number= Lot EL3247 , intramuscular in right arm, on 29Jan2021 at 15:30 as a single dose for COVID-19 immunization . Medical history included sjogren's syndrome, irritable bowel syndrome , raynaud's phenomenon, fibromyalgia , food allergy to peanuts, honey, oranges, strawberries, lobster, molasses, brown sugar, cinnamon. She had the first dose of COVID-19 on 08Jan2021 at 1545 in the right arm. There were no other vaccinations given in the past 4 weeks. She was not tested for Covid prior to vaccination.Concomitant medication included collagen (COLLAGEN), medium-chain triglycerides (MCT OIL [MEDIUM-CHAIN TRIGLYCERIDES]), ergocalciferol (VIT D), fish oil (FISH OIL). The patient previously took gluten and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity. Course as follows: On 29Jan2021: partial throat swelling 90 min after 2nd injection. Took 50mg Benadryl. Became very drowsy and went to bed at 7:30pm. 30Jan2021: Woke at 5am w/chills, headache, body aches, sore R arm, temp of 101.3, dry mouth & LOSS OF TASTE. By 11:30am, fever went up to 103.5. Took 400mg ibuprofen. Went and got a Rapid Covid test (It was negative/undetectable). 4pm diarrhea. Took 400mg Ibuprofen at 6pm and 11:30pm. 31Jan2021: fever 100-101, headache, body aches, sore R-arm, diarrhea, loss of taste, sore throat. 01Feb2021: fever 99-100, headache, body aches, sore R-arm, dry mouth, loss of taste, sore throat. Went to get a 2nd Covid Rapid Test to r/o a false negative (It was negative/undetectable again). 02Feb2021: Fever 99-100, headache, dry mouth, loss of taste. 03Feb2021: temp normal, headache, dry mouth, loss of taste. 04Feb2021- 07Feb2021: temp normal, headache, dry mouth, weird continuous hot/cold flashes, pins & needles tingling all persist. Appt w/PCP scheduled for 17Feb2021. The patient was not hospitalized for the events. The patient was tested for Covid-19 on 01Feb2021 and was negative. The outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,PVT,COLLAGEN; MCT OIL [MEDIUM-CHAIN TRIGLYCERIDES]; VIT D; FISH OIL,,Medical History/Concurrent Conditions: Fibromyalgia; Food allergy; Irritable bowel syndrome; Peanut allergy; Raynaud's syndrome; Sjogren's syndrome; Sulfonamide allergy,,,"['Ageusia', 'Body temperature', 'Chills', 'Dry mouth', 'Headache', 'Hot flush', 'Pain', 'Pain in extremity', 'Paraesthesia', 'Pharyngeal swelling', 'Pyrexia', 'SARS-CoV-2 test', 'Somnolence']",2,PFIZER\BIONTECH,OT 1100330,NC,,F,"tested positive for covid in between first and second dose; positive for Covid/ PCR and it tested positive; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EX9231 and expiry date: unknown), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for covid in between first and second dose on 2021. The physician told the patient to go for a test that day. The first test was a rapid test and it tested negative and the second test was PCR and it tested positive on 2021. So, physician said that patient was positive for Covid. Patient had no reaction, was fine and was doing okay. This coming Thursday, 11Feb2021, patient was scheduled to go for the second shot but she can't go because her husband was sick. She cancelled the appointment but wanted to know how soon will she be able to go get the second shot if she needs the second shot. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1100331,,,M,"dental emergency; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller was reporting on behalf of her husband. After receiving their first shot of the Pfizer vaccine, her husband (patient) now had a dental emergency for which the dentist had requested he took antibiotics; clarithromycin (BIAXIN), in order to extract a tooth. Outcome of event was unknown. � Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Tooth disorder'],1,PFIZER\BIONTECH, 1100333,FL,,M,"tested positive for covid; tested positive for covid/ headache, fever, chills; This is a spontaneous report from a Pfizer sponsored program. Contactable consumer (patient's daughter) reported similar events for two patients. This is the first of two reports. A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 18Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter was contacting Pfizer for her father, 57-year-old male. He got 1st dose on 18Jan2021, on the 31Jan2021 he got a few symptom: Headache, fever, chills. On 01Feb2021, father tested positive for Covid. On 07Feb2021 repeat Covid test was negative. They were asking if he can get his 2nd dose today or should he wait? Her father tested positive for the COVID virus. Her father only had symptoms for one day. She stated that on 31Jan2021, her father had a headache and a few chills, but that was about it. On 01Feb2021, her father went and got tested for COVID and it was positive. Her father stayed home and quarantined, and then on 07Feb2021, he went back to repeat the test and it came back negative. Caller states that today, her father is supposed to get the second round of the vaccine, but he does not know if he can get it today since he just had COVID last week, or if he should wait. Her dad received his first 1st dose on 18Jan and 2nd dose is scheduled today 08Feb. Last 31Jan, her dad had fever and little chills and on the 01Feb her dad tested positive. The daughter is asking if her dad can get the 2nd dose today even though he tested positive before. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021136628 same reporter/ drug, similar event, different patient.;US-PFIZER INC-2021136628 same reporter and drug, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,02/01/2021,14.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1100336,NC,81.0,M,"he tested COVID-19 positive; he tested COVID-19 positive; fever and chills; fever of 100.5; takes all his energy to walk around or eat or do anything; injection site turned red and sore; injection site turned red and sore; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 15Feb2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL2347), intramuscularly, in the left arm, on 29Jan2021 at 11:00 at single dose for COVID-19 immunisation. Medical history included esophageal cancer from 2020, had major surgery from an unknown date about 4 months ago, and a third of his esophagus was taken out from an unknown date. There were no concomitant medications. No history if immunizations were provided. No other vaccines within 4 weeks prior to vaccination. The patient had the first dose on 29Jan2021 at 11:00 at a site sponsored by the health department, on 12Feb2021, it was reported that patient tested COVID-19 positive. On 31Jan2021, the patient reported that he had chills and a fever of 100.5, a couple times his fever spike up and goes away. He does not want to do anything since it takes all his energy to walk around or eat or do anything. On 29Jan2021, after the injection, the patient reported injection site turned red and got sore. He is asking how long the symptoms last. The events did not require physician's office or emergency room visit. No treatment was given. The outcome of the events injection site turned red and sore was recovered while for the rest of the events was unknown. The patient was asking if he should get the second dose.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Esophageal cancer (Verbatim: Esophageal cancer); Esophagectomy; Surgery (He had major surgery about 4 months ago),,,"['Asthenia', 'Body temperature', 'COVID-19', 'Chills', 'Drug ineffective', 'Pyrexia', 'SARS-CoV-2 test', 'Vaccination site erythema', 'Vaccination site pain']",1,PFIZER\BIONTECH,OT 1100339,KY,,F,tested positive for covid-19; tested positive for covid-19; This is a spontaneous report from a contactable pharmacist via a Pfizer-sponsored program Pfizer First Connect and medical information. A 6-decade-old (reported as in her late 50's) female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at unknown vaccination age via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that they had a patient who works in a long-term care facility (nursing facility reporting). The reporter stated that she has a nurse patient reporting she had first dose on an unspecified date and then tested positive for COVID-19 on an unspecified date. The reporter mentioned that the patient is scheduled to receive the second dose on 18Feb2021. The pharmacist inquired if the patient should receive the second dose on 18Feb2021 or if it should be delayed. The outcome of the events was unknown. � Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and Covid 19 positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1100340,,,F,"patient received the Pfizer COVID-19 vaccine/got the COVID infection; patient received the Pfizer COVID-19 vaccine/got the COVID infection; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the Pfizer COVID-19 vaccine on an unspecified date and she and her husband both got the COVID infection on an unspecified date. The outcome of the event was unknown. Information on lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1100349,,,M,"received the first dose of the Pfizer vaccine and has now tested positive for Covid after this dose; received the first dose of the Pfizer vaccine and has now tested positive for Covid after this dose; This is a spontaneous report from a contactable consumer (patient's daughter) via Medical Information Team. A 73-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter said that the patient received the first dose of the Pfizer vaccine and has now tested positive for COVID after this dose on an unspecified date. He was scheduled to get the second dose on 12Feb2021 and she (reporter) wanted to know if it was ok for him to proceed with the second dose. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1100350,AL,39.0,F,"COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm, via an unspecified route of administration on 29Dec2020 15:45 at single dose (lot number: FH9899), then received the second dose on the left arm, via an unspecified route of administration on 19Jan2021 15:45 at single dose (lot number: EL3302) for COVID-19 immunization. Medical history was reported as none. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. There were no other vaccines in 4 weeks and no other medications in two weeks. The patient started having flu like symptoms on 07Feb2021. She went to the clinic. She tested positive for Covid on rapid test. They took 2nd swab and sent to lab. It's positive too. She had temp 99 even after Tylenol. Headache, chills, running nose, sneezing, and body aches. She just thought you all should know. She doesn't know if the lab tested for other strains. The adverse event started on 07Feb2021 07:00. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse event. The patient had no Covid prior to vaccination and was Covid tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,02/07/2021,40.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Body temperature', 'COVID-19', 'SARS-CoV-2 test', 'Vaccination failure']",1,PFIZER\BIONTECH, 1100355,NJ,,U,"after administering the first dose of COVID-19 vaccine, the patient was diagnosed with COVID-19; after administering the first dose of COVID-19 vaccine, the patient was diagnosed with COVID-19; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for three patients. This is the third of three reports. The mother reported that the patient (her second child) of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that after administering the first dose of COVID-19 vaccine, the patient was diagnosed with COVID-19 on an unspecified date. The patient was administered monoclonal infusion as treatment. The mother asked if the patient can still get the second dose of the COVID-19 vaccine as scheduled. The outcome of the events was unknown. Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130061 same reporter/ vaccine, different patient, similar event;US-PFIZER INC-2021133627 same reporter/ vaccine, different patient, similar event",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1100356,NJ,,U,"patient was diagnosed with COVID-19; patient was diagnosed with COVID-19; This is a spontaneous report from a contactable consumer (mother). The consumer reported similar events for three patients. This is the 2nd of 3 reports. The mother reported that the patient (first child) of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that after administering the first dose of COVID-19 vaccine, patient was diagnosed with COVID-19. The patient was administered Eli Lilly monoclonal infusion and the mother asked if the patient can still get second dose of COVID-19 vaccine as scheduled. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021133622 same reporter/ vaccine, different patient, similar event;US-PFIZER INC-2021130061 same reporter/ vaccine, different patient, similar event",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1100357,FL,,F,"got her 2nd dose while she was covid positive (test positive the day after 2nd dose); got her 2nd dose while she was covid positive (test positive the day after 2nd dose); This is a spontaneous report from a contactable consumer (patient's child). This consumer reported similar events for two patient. This is the second of two reports. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient unknowingly got her 2nd dose while she was covid positive (test positive the day after 2nd dose) on an unspecified date. Reporter stated that the patient ""was fine"". Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130210 same reporter and drug, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1100358,,,F,"Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 15Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 29Jan2021, the patient began to experience headaches, fatigue, cough and chest congestion. Then on 02Feb2021, the patient had tested positive for COVID-19. The outcome of the event, 'tested positive for COVID-19', was unknown. The patient was asking if she should get the second dose of vaccination or should wait three months post-infection; or should she begin the process again of taking the first and second dose; or should refrain completely from getting further vaccine doses. Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/15/2021,02/02/2021,18.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1100360,SC,63.0,F,"drippy nose; She felt cold and chills but no fever; She felt cold and chills but no fever; lots of nasal congestion; chest congestion; productive cough; sinus infection; allergy symptoms; testing positive for Covid infection following administration for the first vaccine dose; testing positive for Covid infection following administration for the first vaccine dose; sore throat; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), via an unspecified route of administration in Deltoid Left on 19Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included Slightly elevated blood pressure from Feb2021 and ongoing, Elevated cholesterol from Feb2021 and ongoing. Concomitant medication included pravastatin (PRAVASTATIN) from Feb2021 and ongoing for Elevated cholesterol, lisinopril (LISINOPRIL) from Feb2021 and ongoing for Slightly elevated blood pressure. The patient experienced testing positive for covid infection following administration for the first vaccine dose on 04Feb2021. COVID: Initially reported onset of symptoms as 29Jan2021, but clarified onset of symptoms night of, or morning of 28Jan2021. She always had allergy symptoms like a drippy nose; she was getting ready to go get allergy testing in a few weeks; but on 28Jan2021 she noticed a real increase of sicker drainage all through the night. She thought she might had had a sinus infection. She felt cold and chills but no fever; she never had a fever; but had chills daily. She also had really bad sore throat that went away the next day; and lots of nasal congestion; chest congestion; productive cough. She still had nasal congestion and a little bit of chest congestion but chest congestion was very light in color. She had had no trouble breathing or shortness of breath; other than from her nose being stopped up. Seriousness criteria: Caller reported no emergency room visit, doctor's office visit or hospitalization related to this event. The patient underwent lab tests and procedures which included Flu test: unknown results on 03Feb2021, SARS-CoV-2 RT-PCR test: positive on 04Feb2021. The outcome of event sore throat was recovered 1 day later on unspecified date, lots of nasal congestion was not recovered, while for other events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,02/04/2021,16.0,PVT,PRAVASTATIN; LISINOPRIL,Blood cholesterol increased; Blood pressure increased,,,,"['COVID-19', 'Chills', 'Drug ineffective', 'Feeling cold', 'Hypersensitivity', 'Influenza virus test', 'Nasal congestion', 'Oropharyngeal pain', 'Productive cough', 'Respiratory tract congestion', 'Rhinorrhoea', 'SARS-CoV-2 test', 'Sinusitis']",1,PFIZER\BIONTECH, 1100370,CA,45.0,F,"being sleepy; tired; Body aches; low grade temperature; This is a spontaneous report from a contactable consumer reporting for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 25Jan2021 at 13:30 (at the age of 45 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 05Jan2021 at 12:00 (at the age of 44 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient did not experience any adverse events to previous vaccinations. Relevant medical history and concomitant medication were none. On 26Jan2021 in the evening, the patient experienced low grade temperature and body aches. On 28Jan2021, the patient experienced being sleepy and tired than normal. She said the sleepiness and tiredness has not lifted since she got the shot. She also said she gets tired anyway. The events did not result in an ER or physician's office visit. The outcome of the events low grade temperature, body aches, being sleepy and tired was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/25/2021,01/26/2021,1.0,OTH,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Body temperature', 'Fatigue', 'Pain', 'Pyrexia', 'Somnolence']",2,PFIZER\BIONTECH, 1100374,IN,54.0,M,"sore arm with both shots; Caller stated that he had an antibody test on 05Feb2021 and the test was negative.; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable physician (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 (first dose, lot number: EK5730) and 19Jan2021 14:00 (second dose, lot number: EL3248) both in left shoulder at 0.3 mL, single for prevention. The patient medical history was not reported. There were no concomitant medications. He had 2 doses of covid vaccine with no side effect. 15 days later, he had antibody test on 05Feb2021 and the test of IgM and IgG basically were negative. He had no antibodies to the coronavirus. So he was not sure whether or not he got a vaccine that was too old, not taken care of properly, but he had no immune response 15 days after the second dose he should have developed a response, developed antibodies. He was inquiring if that was effective and wanted to know if he should get another antibody test and take another dose of the Pfizer vaccine or get the Moderna vaccine. The patient stated seriousness as it was serious, it did not require hospitalization, he was not ill at least and had been self-isolating very well, but he was thinking long term, he was feeling well, had no problems, no complications related to the vaccine, other than a sore arm with both shots, that's it, it went smoothly, it was serious, he hoped to have some protection, but was concerned he had none. The patient had sore arm with both shots. The outcome of event antibody test negative was not recovered and event sore arm was unknown.; Sender's Comments: It was noted that patient had antibody test and the test of IgM and IgG basically were negative. He had no antibodies to the coronavirus. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/29/2020,02/05/2021,38.0,PVT,,,,,,"['Pain in extremity', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 antibody test negative']",1,PFIZER\BIONTECH, 1100393,CA,,M,"tested positive for Covid after first dose of vaccine; tested positive for Covid after first dose of vaccine; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of two reports (the husband). An 8-decade-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 18Jan2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 03Feb2021 the patient tested positive for covid after first dose of vaccine. The patient lab tests which included sars-cov-2 test: Positive on 03Feb2021. The consumer stated they were both tested for Covid on 01Feb2021 and found out they were positive for Covid on Wednesday. The consumer stated they were due to get second vaccine ""yesterday"", but are confused about when to get it or if they can get it, stated the doctor told them they could get it but she was calling to see what Pfizer had to say, stated they are confused. The clinical outcome of tested positive for Covid after first dose of vaccine was unknown. Information on the Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021137791 Same reporter/drug/AE and different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,02/03/2021,16.0,UNK,,,,,,"['Drug ineffective', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1100396,,24.0,F,"Passed Out; upset stomach; Dry heaving; Stomach Cramps; Chills; Fever; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient (not pregnant) received bnt162b2 (lot number unknown), via an unspecified route of administration, at Left arm, on 05Feb2021 16:15 at SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. The patient experienced woke up out of her sleep, upset stomach. Dry heaving. Stomach Cramps. Chills. Fever. Passed Out. Adverse event started on 06Feb2021 12:00 AM. No treatment AE. The outcome of the event was recovered in Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/06/2021,1.0,WRK,,,,,,"['Abdominal discomfort', 'Abdominal pain upper', 'Chills', 'Loss of consciousness', 'Pyrexia', 'Retching']",UNK,PFIZER\BIONTECH, 1100397,OR,36.0,F,"questioning Rheumatoid Arthritis; Pain in feet, ankles, knees, shoulders, neck and wrists; Feels like all of my joints are broken; stiff neck; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in the right arm on 20Jan2021 14:30 PM at single dose for covid-19 immunisation. The patient was not pregnant. Medical history included Lupus. No known allergies. Concomitant medication (other medications in two weeks) included melatonin and ibuprofen. No other vaccine in four weeks. No Covid prior vaccination. No covid tested post vaccination. The patient experienced feels like all of my joints are broken, questioning Rheumatoid Arthritis. Pain in feet, ankles, knees, shoulders, neck and wrists. Stiff neck. All from 23Jan2021 06:00 AM and resulted in Doctor or other healthcare professional office/clinic visit. Treatment epi for events included Medrol steroid shot. The outcome of events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/20/2021,01/23/2021,3.0,UNK,MELATONIN; IBUPROFEN,,Medical History/Concurrent Conditions: Systemic lupus erythematosus,,,"['Arthralgia', 'Joint injury', 'Musculoskeletal stiffness', 'Rheumatoid arthritis']",1,PFIZER\BIONTECH, 1100402,,,U,"We went for the rapid test and we were both been positive. We both have COVID now; We went for the rapid test and we were both been positive. We both have COVID now; Little bit of displaced pain on the top and on the back of my arm, not at the site; Next couple of days, I was a little off, I felt a little off not myself; By Sunday I was feeling ill; on Sunday I started to get these symptoms; I had what I thought was sinus; Headache; I started to get a clogged up nose; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccination, everything was fine, the patient had a little bit of displaced pain on the top and on the back of arm, not at the site. But it went away and then the next couple of days, the patient was a little off, felt a little off not himself/herself. So, the patient just got well and things were fine. The patient went ahead and went about business, life had been great. The patient had been looking forward to had second shot, the patient planned for it just coming Monday, at the same place they did it of course right away, they had scheduled it. So, the patient was looking forward to that. And then near then patient's husband's mother passed away, and he had to get things out settled up and he went away. And he came back last Friday and by Sunday the patient was feeling ill. The patient had what thought was sinus, the patient was having headache and started to get a clogged up nose, and so the patient started to take sinus medication (Unspecified Medication) thinking that, that would subside, but it seemed to be getting worst but the patient was okay. The patient's husband exhibited a lot of symptoms. And he by the way he complicated things. He got his shot, his first Pfizer shot on January 20th, and then on the 24th he left to go to a place. He came home on the end of the week, he came on Friday. He was coughing and exhibiting extreme fatigue, but he also suffered from chronic fatigue syndrome and other underline situations, so he attributed to that. So he went ahead and they cohabitated and on Sunday the patient started to get these symptoms. This past Wednesday (03Feb2021) he came to the patient and said he had no sense of taste or smell, and they know what that meant. So, he immediately went to get a COVID test, but he had to wait. And then in the interim the patient's situation pretty much stayed rather static, it didn't much change. Then on Thursday he said the patient was going for a rapid test, the patient wanted to go too. So, they went ahead and they went to an urgent care and they went for the rapid test and were both been positive. They both had COVID now. The outcome of events was unknown. Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021146493 same reporter/product, different patient, similar event",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,01/01/2021,,PVT,,,,,,"['COVID-19', 'Drug ineffective', 'Feeling abnormal', 'Headache', 'Malaise', 'Nasal congestion', 'Pain in extremity', 'SARS-CoV-2 test', 'Sinusitis']",1,PFIZER\BIONTECH, 1100405,,,M,Got his first shot a couple weeks ago and then after that he Covid tested positive; Got his first shot a couple weeks ago and then after that he Covid tested positive; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2 reported as Pfizer Covid-19 Vaccine; unknown lot number and expiration date) at unknown vaccination age via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he got his first shot a couple weeks ago (unspecified date) and then after that he tested Covid positive on unspecified date. He would like to know if he could still take his second dose as his quarantine will end tomorrow (09Feb2021). The outcome of the events was unknown. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1100410,NY,44.0,F,"She received her first Pfizer COVID-19 Vaccine on 19Jan2021/ tested positive for the COVID-19 Virus on 08Feb2021/ been sneezing and has lost taste and smell; She received her first Pfizer COVID-19 Vaccine on 19Jan2021/ tested positive for the COVID-19 Virus on 08Feb2021/ been sneezing and has lost taste and smell; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect and COVAX US Support from a contactable consumer (patient). A 44-year-old female patient (also age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at the left arm on 19Jan2021 15:40 at SINGLE DOSE for covid-19 immunization. The patient was vaccinated at a hospital. Medical history was none and she has no prior health history. The patient has no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior vaccinations within 4 weeks. For concomitant medications the patient has been taking vitamins, supplements, and iron for quite sometime. The patient received her first Pfizer COVID-19 Vaccine on 19Jan2021 (reported as 3 weeks ago). The patient stated that she has been sneezing and has lost taste and smell. She took a Covid test on Friday (05Feb2021: COVID-19 PCR test) and received negative results on Saturday (06Feb2021: COVID-19 PCR test). She said she tested positive for the COVID-19 Virus on 08Feb2021 (COVID-19 PCR test). She said she was supposed to go for the second COVID-19 Vaccine on 09Feb2021. She said she went to the COVID-19 Vaccine site that administered her first vaccine dose, and was told she couldn't get her second COVID-19 Vaccine dose/ missed appointment because she tested positive for the COVID-19 Virus. She said she was asked to call back this week to rescheduled her second COVID-19 Vaccine dose, but she hadn't done so because her father just passed away. She stated she required no treatment, and quarantined after the positive COVID-19 Virus test result. The patient did not require a visit to Emergency Room or Physician Office. The outcome of the events was unknown. The patient added she is ""not sick at this time"" and has no pre-existing conditions and seeking guidance on the next dose and wanted to know if she is eligible to get the second COVID-19 Vaccine dose, asking about the timing of the second if it would still be valid even if it is beyond the recommended 3 week period?",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/19/2021,02/08/2021,20.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1100411,OH,,U,"tested positive for Covid 19; tested positive for Covid 19; This is a spontaneous report from a Pfizer-sponsored program, PFIZER FIRST CONNECT. A contactable pharmacist reported similar events for three patients. This is the second of the three reports. A patient of unspecified age and gender received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Jan2021, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, after the first vaccination, the patient had COVID-19 confirmed by positive COVID-19 test and was put on isolation. The outcome of the event was unknown. The reporting pharmacist was wondering if there was a need to hold off the second dose of vaccination or if it could be administered on 07Feb2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021148567 same drug and event, different patient;US-PFIZER INC-2021148508 same drug and event, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/17/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1100414,FL,,M,"Tested positive after getting the first dose of covi-19 vaccine.; Tested positive after getting the first dose of covi-19 vaccine.; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer ( patient) of unspecified age received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive after getting the first dose on an unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1100421,AZ,63.0,M,"body ache; feeling worse; when I went to bed, got chills and shivers real bad; headache; Mild fever; mildly sore arm; Bad prostate and bladder infection; Bad prostate and bladder infection; This is a spontaneous report from a contactable consumer (patient himself) via a medical information team and Pfizer-sponsored program COVAX US Support. A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/ lot number: EL9269, Expiration date: Unknown, NDC number: Unknown), via an unspecified route of administration in left shoulder area on 08Feb2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included ongoing asthma for about 60 years, ongoing high blood pressure for about 3 years and was on blood pressure medication, issues with thyroid for about 3 years and was on thyroid medication (ongoing). Concomitant medication included ongoing thyroid medication. Patient's medical history (including any illness at time of vaccination) was none. Family medical history relevant to adverse events was none. Prior vaccinations (within 4 weeks) was none. Adverse events following prior vaccinations was none. Additional vaccines administered on same date of the Pfizer suspect was none. The patient experienced bad prostate, bladder infection, sore arm on an unspecified date in Feb2021. On 11Feb2021, the patient experienced body aches, feeling worse, shivers, headache, mild fever. It was reported that, caller received his first dose of bnt162b2 on Monday 08Feb2021. He's reporting adverse events and would like to know: If he takes Tylenol to treat his symptoms, would it decrease the effectiveness of the vaccine or not. Also, if he were to go for a COVID-19 viral test, would the fact that he was received the vaccine interact with the test and cause a false positive result or not. Patient was reporting that yesterday, day 4, he started with body aches, headache, and ""when he got in bed, he had chills and shivers real bad, little chilly"" so possibly a mild fever. Enquired could these all be side effects of the vaccine or not. If he go for the COVID test - would it be positive or not. He also states he has a history of asthma and has been hypervigilant about avoiding COVID infections. Caller, reporting on the COVID vaccine and who explains that he got the first shot on Monday and he had a mildly sore arm- this lasted 2-3 days, no big deal. Then 5 days later he had really bad body aches and a headache. He went to bed cause he was feeling worse but before going to bed he noticed he had shivers really bad, uncontrollably almost which lasted over an hour. He presume they are fairly normal side effects but wants to confirm this could happen after five days. Also, he was told not to take Aspirin or Tylenol before getting the vaccine because it could affect the efficacy, but he wants to know could he take a Tylenol now 5 days later for the headache and body aches. He was better now than he was doing. Caller clarified the event was 4 days after the shot, the shot was Monday and events started Thursday. On Thursday evening, 11Feb2021, was when he had the bad body aches, headache, and shivers. At this point he still has the headache and body ache. He felt like, last night, he had a fever, but he didn't check it. At the same time, he had the chill and the shivers. Those feelings were resolved by this morning. Caller received COVID vaccine on 08Feb2021-Internal Infection-Bad prostate and bladder infection. Adverse events did not require visit to emergency room and physician office. No relevant tests. No investigation assessment. The events were considered as non-serious by the consumer. The outcome of the events mild fever, feeling worse, bad prostate, bladder infection was unknown, recovering for body aches, headache, recovered on 12Feb2021 for shivers, recovered on an unspecified date in Feb2021 for sore arm.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/01/2021,,UNK,,Asthma (Asthma for about 60 years); Blood pressure high (High blood pressure for about 3 years and was on blood pressure medication),Medical History/Concurrent Conditions: Thyroid disorder (Issues with thyroid for about 3 years and was on thyroid medication (ongoing)),,,"['Chills', 'Cystitis', 'Feeling abnormal', 'Headache', 'Pain', 'Pain in extremity', 'Prostate infection', 'Pyrexia']",1,PFIZER\BIONTECH, 1100422,ND,64.0,F,"angioedema; Face & tongue tingling; Face & tongue tingling; Itching all over; rash on limbs & chest; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via an unspecified route of administration on 11Feb2021 11:15 (at the age of 64-year-old) at single dose in right arm for covid-19 immunisation. The patient other medical history included seizure disorder, hypertension, obesity, IBS (Irritable bowel syndrome), chronic rhinitis, atrial fibrillation. The patient had known allergies. No other vaccine in four weeks. The patient had received other medications in two weeks. The patient experienced face & tongue tingling. Itching all over, angioedema, rash on limbs & chest, swollen lymph nodes on 11Feb2021 12:00 PM. The patient received the treatment of events included diphenhydramine (BENADRYL). The outcome of the events was recovering.; Sender's Comments: The causal association between the reported event angioedema and BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Allergy (known allergies: Yes); Atrial fibrillation; Chronic rhinitis; Hypertension; Irritable bowel syndrome; Obesity; Seizure,,,"['Angioedema', 'Lymphadenopathy', 'Paraesthesia', 'Paraesthesia oral', 'Pruritus', 'Rash']",1,PFIZER\BIONTECH, 1100425,AR,,F,"tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID-19. The patient was scheduled for her second vaccination and asked if she still needed to receive the second dose. The clinical outcome of tested positive for COVID-19 was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1100426,MO,,M,"headache; nausea; chilling; generalized achiness; flu-like symptoms; positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable consumer or other non hcp. A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982) via an unspecified route of administration in left arm on 29Jan2021,16:15 at single dose for COVID-19 immunisation. Medical history included hypertension, osteoarthritis, prostate cancer, nephrolithiasis, glaucoma and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 03Feb2021, the patient experienced headache, nausea, chilling, generalized achiness, flu-like symptoms. Adverse events: 12-24 hrs after the vaccine the patient experienced headache, nausea, chilling, and generalized achiness (basically flu-like symptoms). The symptoms resolved within 24 hrs. The patient never experienced any fever. Since he was having an OP surgery, he had to have a pre-op COVID-19 test (done 01Feb2021) which was positive. He was informed on 03Feb2021 that the COVID-19 test was positive and surgery and radiation had to be postponed. He was totally asymptomatic the entire time during his quarantine time, as well as since then. The outcome of the event COVID-19 test with no symptoms and drug ineffective was unknown and outcome of all other events was recovered on Feb2021. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,02/01/2021,3.0,UNK,,,Medical History/Concurrent Conditions: Glaucoma; Hypertension; Kidney stone; Osteoarthritis; Prostate cancer; Sulfonamide allergy,,,"['Asymptomatic COVID-19', 'Chills', 'Drug ineffective', 'Headache', 'Influenza like illness', 'Nausea', 'Pain', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1100431,PA,,F,stroke; eye also felt funny found she blew a blood vessel; After the 2nd shot on the 29th she had the taste of rubber bands in her mouth; her face started to go numb.; Her Blood pressure was 150; she felt like she was hit by a truck; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received second of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included migraines and they cause numbness in her face sometimes. The patient's concomitant medications were not reported. After the 1st shot of BNT162B2 she had a metal taste in her mouth. After the 2nd shot on the 29nd she had the taste of rubber bands in her mouth. After waiting 10 mins her face started to go numb. Her Blood pressure was 150. HCP thought it was a stroke but she just went home. She had a history of migraines and they cause numbness in her face sometimes. She took migraine medications and it didn't help. Next day face numbness went away but she felt like she was hit by a truck. Her eye also felt funny found she blew a blood vessel. The outcome of events was unknown. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,Y,,,,UNK,,,Medical History/Concurrent Conditions: Migraine; Numbness in face (history of migraines and they cause numbness in her face sometimes),,,"['Blood pressure abnormal', 'Blood pressure measurement', 'Cerebrovascular accident', 'Dysgeusia', 'Eye haemorrhage', 'Feeling abnormal', 'Hypoaesthesia']",2,PFIZER\BIONTECH, 1100441,,,M,"they both have covid; they both have covid; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients (herself and her husband, the patient). This is the second of two reports. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 20Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The wife reported that she received the first dose of the Pfizer Covid vaccine on 18Jan2021, and the patient (her husband) received it on 20Jan2021. The wife stated she was diagnosed with Covid last Thursday and she got it from the patient - they both have Covid. They both received antibodies from (company name) as it was a mild case. She said she and the patient were congested, had fatigue and the antibodies made a difference. She then added that so many people can only take the first dose due to the side effects or some other reason. She wanted to know the time they needed to wait in order to get the second dose of the vaccine, if it was 90 days. The outcome of the events was unknown. Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130575 same reporter, drug, and events, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/20/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1100453,NC,,F,"neuropathy; arthritis; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient, self-reported). A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry dates were not provided), via an unspecified route of administration on an unspecified date, as SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that patient wants to know that if she supposed to take Tylenol after having first shot of Vaccine. On an unspecified patient experienced neuropathy and arthritis. Patient took the medication Tylenol after the first dose. The outcome of the events was unknown. Information of lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Arthritis', 'Neuropathy peripheral']",1,PFIZER\BIONTECH, 1100455,MD,66.0,F,"full blown auto immune flare/ a great big flare; mild headache; temperature of 102 degrees; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration on 21Jan2021 (at age of 66 years old) at single dose for COVID-19 immunization. The patient's medical history included autoimmune diseases (She had a host of autoimmune diseases. Her body was one big inflammatory responses). Concomitant medications were not reported. The had reactions and was concerned about getting the second dose. She had a host of autoimmune diseases. Her body was one big inflammatory responses. Her doctor figured she would feel it. She started with a mild headache. On the 7th day she was slammed. Her doctor said it was pretty unusual after this long. She had a temperature of 102 degrees. It was like having a full blown auto immune flare that lasted for two days and went away. She was left with a great big flare. She was not able to provide full details as she had an appointment that she had to pay out of pocket for. She was not concerned about the reaction that takes a day or 2 to get over. She was having hell from her usual responses. She was afraid in six months she would be crippled. The outcome of events was unknown. She was due to receive the second dose on Tuesday.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/21/2021,,,UNK,,,Medical History/Concurrent Conditions: Autoimmune disorder (She had a host of autoimmune diseases. Her body was one big inflammatory responses),,,"['Autoimmune disorder', 'Body temperature increased', 'Headache', 'Pyrexia']",1,PFIZER\BIONTECH, 1100463,OH,69.0,F,"had no COVID-19 antibodies; catastrophic hearing loss/could not hear out of my left ear/My left ear is what 'went'; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264), via an unspecified route of administration on 09Feb2021 15:00 at single dose for COVID-19 immunisation. Medical history included kidney transplant from an unknown date. Concomitant medication included cyclosporine (CYCLOSPORINE), mycophenolate mofetil (MYCOPHENOLATE). The patient was on the Cyclosporine 50 mg in the morning and 50 at night and Mycophenolate 180 times 3, 540 in morning and 540 at night. (Not appropriately clarified). The patient woke up at 3am in 20Feb2021 and she completely lost hearing in her left ear. She went to her ear doctor and her doctor diagnosed her with ""catastrophic hearing loss"" which is pretty unusual as said by her doctor. The only intervention that they could think of is getting the Pfizer COVID-19 vaccine. She wanted to know if this has been a reported adverse event with the Pfizer BioNTech COVID-19 vaccine. If so, is it permanent or temporary? She wanted to have more information so she can tell this to her doctor. She also mentioned that she found a ""Pfizer worksheet"" online and hearing loss was listed as an adverse event in that document. She showed it to her family doctor and her family doctor agreed that it may be associated with the Pfizer COVID-19 vaccine. Consumer stated, that she got COVID-19 Vaccine on February 9th, at 3 o'clock in the afternoon and she woke up last Saturday and she could not hear out of her left ear. She called family doctor and then called ENT doctor and went in yesterday and had some tests and some hearing tests and the doctor said it was catastrophic Hearing Loss which he sees rarely and the patient tried to look online and finally tried to look for what the heck happened because they had a lot of previous tests and her hearing was fine and all of a sudden just literally changed overnight. So, she looked up the Pfizer COVID-19 possible side effects and she did see in the COVID-19 Vaccine that it mentioned hearing loss. So, she talked to doctor and he simply said you probably have to report it. When paraphrased the above concern, consumer stated, a possible side effect. You got me, what caused it is odd and everybody said. Family doctor said it was odd. Her ear doctor said it was odd. Has anybody else reported that side effect and if so, is it permanent or temporary? When offered the number of Pfizer Medical Information, consumer stated, her left ear is what 'went'. Now she has to mess around because she has to hold the phone around her right ear and then have to use her left hand because right hand (incomplete sentence). About treatment, consumer stated, she went to the ear doctor and he ran some hearing tests and he put her on prednisone which she started last night. So, he put her through a 'regime' of prednisone, of steroids. About Laboratory work, Consumer stated, she did have some lab work prior to February 9th because she was a kidney transplant patient and she was in the Study. They are studying how the COVID-19 vaccine works on the transplantations. So, she had a blood test. The results went to facility. She did know they sent her a letter saying that she had no COVID-19 antibodies (Clarification unknown). Consumer added, she was a little concerned and would at least like to know if anybody else has reported something like this. That would be helpful. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/09/2021,02/20/2021,11.0,UNK,CYCLOSPORINE; MYCOPHENOLATE,,Medical History/Concurrent Conditions: Kidney transplant,,,"['Acoustic stimulation tests', 'Blood test', 'Deafness unilateral', 'Investigation', 'SARS-CoV-2 antibody test negative']",1,PFIZER\BIONTECH, 1100464,CA,74.0,F,"suffered a neurological setback following the first injection; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date in Dec2020 at a single dose for COVID-19 immunization. The vaccine facility type was reported as the nursing home/senior living facility. Relevant medical history included multiple sclerosis (advanced stages), diabetes, and COVID-19 prior vaccination; all from an unknown date and unknown if ongoing. The patient had other medications in two weeks, which included diabetic medications (meds, pills), anti depressants, etc. The patient had no other vaccine in four weeks. The patient was not pregnant at the time of vaccination. On an unspecified date in Dec2020, the patient suffered a neurological setback following the first injection, although it wasn't terribly obvious at that time. The event was considered serious as it resulted in disability or permanent damage. The patient underwent lab tests and procedures, which included an unknown COVID-19 test via nasal swab: negative on an unspecified date in Jan2021. It was unknown if the patient received any treatment for the adverse event (AE). The patient was not recovered from the event. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,N,12/01/2020,12/01/2020,0.0,SEN,,,Medical History/Concurrent Conditions: COVID-19 (if covid prior vaccination: yes); Diabetes; Multiple sclerosis (advanced stages),,,"['Nervous system disorder', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1100465,FL,80.0,F,"Very high glucose + 300 with need for more than 10 extra units insulin per day for 4 days; Diarrhea; Vomiting day 4 to day 6; Continuing nausea; Continuing nausea with loss of 5 lbs; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9810), via an unspecified route of administration, right arm on 14Feb2021 12:15 PM at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient wasn't pregnant at the time of vaccination. The patient's medical history included Allergies to medications, food, or other products included Sulfa, gluten and cortisone meds, diabetes since age 5 and heart failure. List of any other medications the patient received within 2 weeks of vaccination included Thyroid, metoprolol succinate (TOPROL XL), KCL, furosemide (LASIX [FUROSEMIDE]) (reported as Lasux), spironolactone. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced very high glucose + 300 with need for more than 10 extra units insulin per day for 4 days on 17Feb2021 12:00 PM, diarrhea and vomiting day 4 to day 6 and now continuing nausea with loss of 5 lbs because of nausea at day 11 on Feb2021. The patient received additional insulin as a treatment and call to cardiac physician. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the event Blood glucose increased, Diarrhea, Vomiting, Weight loss was recovering and outcome of event Nausea was not recovered. Information regarding lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/01/2021,,OTH,TOPROL XL; KCL; LASIX [FUROSEMIDE]; SPIRONOLACTONE,,"Medical History/Concurrent Conditions: Diabetes (since age 5); Drug allergy (known_allergies: Sulfa, gluten and cortisone meds); Gluten intolerance (known_allergies: Sulfa, gluten and cortisone meds); Heart failure; Sulfonamide allergy (known_allergies: Sulfa, gluten and cortisone meds)",,,"['Blood glucose', 'Blood glucose increased', 'Diarrhoea', 'Nausea', 'Vomiting', 'Weight decreased']",1,PFIZER\BIONTECH, 1100467,IN,73.0,F,"I have had pancreatitis before and it felt like the same thing; About 5 hours after I had the Covid shot I experienced severe abdominal pain, really the whole front of my chest below my breasts to my waist.; This is a spontaneous report from a contactable consumer reported for herself. The 73-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Brand: Pfizer, lot number: EN6201) via an unspecified route of administration on 22Feb2021 14:30 on left arm at single dose for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing, pancreatitis from an unknown date and unknown if ongoing, Allergies to medications, food, or other products: codeine, hydrocodone, amoxicillin, provostatin, narcotics, CT scan contrast IV dye. Concomitant medication included gabapentin, amlodipine, meloxicam, calcium, centru. The patient previously took first dose of bnt162b2 (COVID 19, Brand: Pfizer, lot number: EN5318) on 01Feb2021 01.45 PM on left arm at single dose for covid-19 immunisation, codeine and experienced drug hypersensitivity, hydrocodone and experienced drug hypersensitivity, amoxicillin and experienced drug hypersensitivity. The patient experienced ""i have had pancreatitis before and it felt like the same thing"" on 22Feb2021 08:30AM with outcome of recovered, ""about 5 hours after i had the covid shot i experienced severe abdominal pain, really the whole front of my chest below my breasts to my waist"" on 22Feb2021 08:30AM with outcome of recovered. Therapeutic measures were taken as a result of the events included IV and blood and urine tests. She is not pregnant or not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The consumer reported that ""About 5 hours after I had the Covid shot I experienced severe abdominal pain, really the whole front of my chest below my breasts to my waist. I have had pancreatitis before and it felt like the same thing. I went to the emergency room and indeed had lipase at 3640. The painful part of attack was over within another hour. This was my 5th attack of pancreatitis and I don't know if the vaccination triggered it or not. It is unknown at this time why I have had the pancreatitis attacks. I don't drink or have gall stones."" Ae resulted in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/22/2021,02/22/2021,0.0,PVT,GABAPENTIN; AMLODIPINE; MELOXICAM; CALCIUM,,Medical History/Concurrent Conditions: Allergy; Arthritis; Drug allergy; Pancreatitis,,,"['Abdominal pain', 'Pancreatitis']",2,PFIZER\BIONTECH, 1100468,NJ,55.0,F,"diagnosed with COVID-19 disease/testing positive/sick/all the nightmares of COVID /felt very ill/COVID took the 3 pounds off/fevers my eyes/body temperature kept dropping; diagnosed with COVID-19 disease/testing positive/sick/all the nightmares of COVID /felt very ill/COVID took the 3 pounds off/fevers my eyes/body temperature kept dropping; some fatigue/tired; stomach upset/stomach was really feeling weak; not feeling real well; nauseous; This is a spontaneous report from a contactable consumer reporting for self. This 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunisation. Medical history included menopause hormone replacement therapy. Concomitant medication included progesterone (PROGESTERONE), estradiol (MINIVELLE) for menopause hormone replacement therapy. The patient received her first injection of the Pfizer-BioNTech vaccine on 23Jan2021. She reported experiencing symptoms of COVID-19 on 09Feb2021 and was diagnosed with COVID-19 disease on 11Feb2021 after testing positive. After the first injection, and prior to getting COVID-19 disease, she did experience some fatigue, stomach upset, and not feeling real well. It was reported that when she had the first dose the only symptoms was stomach was really feeling weak, just felt extremely tired and nauseous so that was the first and then fine, by the third day she was feeling okay but then unfortunately, on 09Feb2021 and she began getting sick and went for a COVID test and tested positive on 11Feb2021. She had experienced multiple symptoms due to her COVID-19 disease and had to go to the ER for treatment after they appeared (she went to the emergency room so they didn't keep her there, she was there for maybe 6 hours). She felt very ill with this COVID, she had been in the hospital twice, she did not, she was not left in ICU that was good for her, but reported that ""between the fevers my eyes, I don't know what happened to my eyes but ophthalmologist will be checking it seems to be same and it's been everything that you can ever think as 'hard' and I just want to know if tomorrow I can have the second boost."" It was reported that when she was in the hospital because of the, body temperature kept dropping so the doctor send her to the hospital and they did blood test. Patient weight was 135 at that time, now she was 131. She thought COVID took the 3 pounds off. Her second dose of the Pfizer-BioNTech vaccine was cancelled due to her illness and now her second dose is scheduled for tomorrow (25Feb2021). The patient reported she is only now starting to feel a lot better, that she was really sick for 15 days. Today (24Feb2021) was the first day that she was feeling a little bit better from all the symptoms and all the nightmares of the COVID illness. The outcome of events was recovering.",Not Reported,,Not Reported,Yes,,Not Reported,N,01/23/2021,02/09/2021,17.0,UNK,PROGESTERONE; MINIVELLE,,Medical History/Concurrent Conditions: Menopause,,,"['Abdominal discomfort', 'Body temperature', 'COVID-19', 'Drug ineffective', 'Fatigue', 'Investigation', 'Malaise', 'Nausea', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1100469,NM,62.0,F,"she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed; the lymph node under her arm got inflamed; armpit swelling; her eyes was runny, sort of hurting like salt in her eye; her eyes was runny, sort of hurting like salt in her eye; arm was hurting where she got the vaccine in the right arm; she had a mucus plug and was bleeding; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 62-years, via an unspecified route of administration in right arm on 19Feb2021 at single dose for COVID-19 immunization. Medical history included hadn't had her period for 8 years. Concomitant medications were not reported. The patient historically received first single dose of BNT162B2 at the age of 62-years for COVID-19 immunization. Patient received the 2nd dose of the vaccine last Friday 19Feb2021, when she was driving home her eyes was runny, sort of hurting like salt in her eye, it was like that all evening she had to put a patch on her eye to help it. That same evening may arm was hurting where she got the vaccine in the right arm, and the lymph node under her arm got inflamed. The next morning on 20Feb2021 when she woke up she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed, but that went away. The armpit swelling has continued since the day of the vaccine. Now this morning in Feb2021 she had a mucus plug and was bleeding she haven't had her period for 8 years, every two days she had something new. Patient wanted to know what had been woken up in her body. Consumer added that she read on line that patients should wait for 5months before going to their doctor about the swollen lymph nodes because they might send the person for a test, mammogram and it may say they have cancer, in the clinical trials apparently some patients has issues with their lymph nodes and when they did testing it was found they had cancer, but it was not cancer it was the vaccine. Outcome of the event she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed was recovered/resolved in Feb2021; of the armpit swelling was not recovered/not resolved; while of remain was unknown. Information on lot/batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Menopause,,,"['Eye pain', 'Haemorrhage', 'Lacrimation increased', 'Lymphadenitis', 'Pain in extremity', 'Sensation of foreign body', 'Swelling']",2,PFIZER\BIONTECH, 1100470,NC,72.0,F,"severe Brain fog still 5 days later dysfunctional; severe whole body muscle pain even my fingers hurt 48 hours; severe whole body muscle pain even my fingers hurt 48 hours; drooling woke me up soaked the pillows; headache worse in my life 48 hours; dropping things hands wouldn't work; vomiting; severe diarrhea still problematic; Chills/cold shaking so hard teeth chattered; Chills/cold shaking so hard teeth chattered; Chills/cold shaking so hard teeth chattered; Still can't function normally 5 days now after 2nd shot; Still stuck in the house to weak to leave; Cognitive dysfunction; could not drive; trouble speaking; pins and needles both arms and legs; ataxia; received second dose of bnt162b2 on 19Feb2021; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 72-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer) , via an unspecified route of administration on 19Feb2021 01:15 pm on left arm at single dose for covid-19 immunisation. Medical history included Known allergies: iodine dye X-rays from an unknown date and unknown if ongoing. The patient's concomitant medications were none. The patient previously took first dose of bnt162b2 (COVID 19, brand: Pfizer) on 22Jan2021 at arm at single dose for covid-19 immunization. The patient experienced cognitive dysfunction (cognitive disorder) (medically significant) on 19Feb2021 18:00 with outcome of not recovered, could not drive on 19Feb2021 18:00 with outcome of not recovered, trouble speaking on 19Feb2021 18:00 with outcome of not recovered, pins and needles both arms and legs on 19Feb2021 18:00 with outcome of not recovered, ataxia on 19Feb2021 18:00 with outcome of not recovered, severe brain fog still 5 days later dysfunctional on an unspecified date with outcome of not recovered, severe whole body muscle pain even my fingers hurt 48 hours on an unspecified date with outcome of not recovered, severe whole body muscle pain even my fingers hurt 48 hours on an unspecified date with outcome of not recovered, drooling woke me up soaked the pillows on an unspecified date with outcome of not recovered, headache worse in my life 48 hours on an unspecified date with outcome of not recovered, dropping things hands wouldn't work on an unspecified date with outcome of not recovered, vomiting on an unspecified date with outcome of not recovered, severe diarrhea still problematic on an unspecified date with outcome of not recovered, chills/cold shaking so hard teeth chattered on an unspecified date with outcome of not recovered, still can't function normally 5 days now after 2nd shot on an unspecified date with outcome of not recovered , still stuck in the house to weak to leave on an unspecified date with outcome of not recovered. No treatment received. She is not pregnant. Facility type vaccine was hospital. No other vaccine in four weeks. The patient reported that ""Cognitive dysfunction, could not drive, trouble speaking, pins and needles both arms and legs, ataxia, stumbling. 72 hours of ataxia severe Brain fog still 5 days later dysfunctional severe whole body muscle pain even my fingers hurt 48 hours drooling woke me up soaked the pillows , headache worse in my life 48 hours dropping things hands wouldn't work vomiting and severe diarrhea still problematic Chills/cold shaking so hard teeth chattered Still can't function normally 5 days now after 2nd shot Still stuck in the house to weak to leave , still ataxic."" No COVID prior vaccination. No COVID tested post vaccination. Information about Lot/Batch number is requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/19/2021,02/19/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Iodine allergy,,,"['Asthenia', 'Ataxia', 'Chills', 'Cognitive disorder', 'Diarrhoea', 'Disturbance in social behaviour', 'Drooling', 'Feeling abnormal', 'Headache', 'Impaired driving ability', 'Inappropriate schedule of product administration', 'Muscular weakness', 'Myalgia', 'Nasopharyngitis', 'Pain in extremity', 'Paraesthesia', 'Speech disorder', 'Tremor', 'Vomiting']",2,PFIZER\BIONTECH, 1100471,SC,70.0,F,"syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; soreness, redness, and pain at injection site; her blood pressure was really high and kept going up and down like a roller coaster; She was taken to the ER and began feeling sick to stomach in ambulance; headache; felt her ears vibrating; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; She is anxious about getting the second vaccine; Enlargement of lymph nodes; increased heart rate; This is a spontaneous report from a contactable Nurse reported for self. This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 on Arm left at single dose (Lot # EL9262, Expiration: May2021) for covid-19 immunisation. Medical history included Atrial fibrillation from Jan2020. Had 2nd dose appointment scheduled but canceled appointment. Concomitant medications included apixaban (ELIQUIS) from 07Feb2021 at 5mg twice a day by mouth (provided SN100089537925, LOT 1771228, EXP: May2023, NDC: 0003-0894-21) for Atrial fibrillation. History vaccine included a Tetanus shot 40 years ago (1981) for immunisation and reacted terrible to it. She reports having and experienced soreness, redness, and pain at injection site. She reports getting a mammogram sometime after receiving the vaccine. They saw a spot they are going to recheck and saw swollen lymph nodes on the left side/ Enlargement of lymph nodes, which is the same side she received her vaccine. She was told it was most likely due to the vaccine. Six days later she suddenly felt sick, near syncope, couldn't catch her breath. It got so bad she thought she was dying and called EMS. Leads confirmed afib, her blood pressure was really high and kept going up and down like a roller coaster. She was taken to the ER and began feeling sick to stomach in ambulance. IN the ER she received 1000 ml of fluids and additional metoprolol in addition to dose she took that evening at home. She was sent home to follow up with her Cardiologist the following Monday. He wasn't sure if it was due to vaccine and started her on twice daily eliquis and increased her toprolol immediate release to twice daily. The following Friday night she got a headache and felt her ears vibrating. Her home EKG was fine, but blood pressure was high again and stayed up for hours. Took additional toprolol. Came down after 5 hours. Breast, arm and clavicle starting hurting two weeks and one day after the injection. She is anxious about getting the second vaccine. Asked PCP if she needed an antigen test to see if she needed a second dose of the vaccine. She says she got her first dose 01Feb, then on Wednesday, 03Feb she went and got a mammogram which had already been planned. She says that they saw enlarged lymph nodes to her left breast, under arm, and clavicle which they said are due to vaccine, but they also said they saw something else so they wanted to do a repeat mammogram three months later. She says it took two weeks, but suddenly her left breast and under arm were killing her, caller did not clarify this statement. She says she talked to her doctor who said don't worry it might take a while to go down. She says that the other thing is she has known atrial fibrillation that was diagnosed a year ago, and most of the time it is quick and doesn't last long, sometimes she doesn't know she is having it. She says 6 days after the first dose she started to feel ill, she had been in bed reading so she got up to get some water and suddenly felt like something was wrong and like she was going to pass out, she couldn't breathe, so she called EMS. She says her atrial fibrillation is not unusual, but she has never had it to where she couldn't breath. She says that the rate they estimated was 350, and her only other documented that was high like that was 150. She says that they treated her and she went home, and when she saw her cardiologist they said they don't know if the vaccine had to do with this, and to report it. She says a week later, on Friday a week ago, she started feeling funny standing while she was working on the computer in the middle of the afternoon, she felt like her ears were vibrating, which was very unusual, and she didn't know what was wrong so she looked at her Cardia app, and her heart was in normal sinus, and she checked her blood pressure which for her was sky high, up to 190/100 which her blood pressure is usually very low. She provided a second blood pressure that call handler was unable to capture and caller did not clarify as she no longer had her log with her. She says for hours her blood pressure (BP) went up and down, which was a similar or same thing as what happened that night she went to the ER with her atrial fibrillation, her BP would go up and down like riding a wave. She says needless to say, she has two questions: she says she doesn't know if there have been reports of that vaccine making A-fib worse, she is scared to get her second dose which she was supposed to get Monday a week ago, but put off primarily before the second thing with BP, she thought she would wait because she could hardly move her left arm so she put it off until the next Wednesday, She says that her second dose is now scheduled for 03Mar, so 4 weeks between doses, and she is a little afraid to get it because she doesn't know if her response was over the top or caused the other things, going to the ER with A-fib was terrifying, and she doesn't want that to happen again. She says people say that she has got to get her second dose because she won't be protected, so she would also like to know if it is possible for her to get antigens early on. She says that she had a tetanus shot 40 years ago, and had a horrible reaction after it, then years later they did a titer for tetanus and they said she would likely never need a tetanus shot again since she had built up such a high level and would never need it again. She says is it possible that she had enough immunity that she wouldn't need the second dose, or would there be an antigen test that could tell her if she would need a second dose, if so what is that test? She says she is afraid the next dose will kill her. AE treatment included says that when she went to the ER it was about 12:30AM when she arrived, they did not admit her. She says on the way to the ER in the EMS truck they gave her Cardiozyme to get her blood pressure going down and gave her 1000 cc fluids, and Metoprolol, another dose. She says that the Cardiozyme was IV push in the ambulance, she doesn't have the information to provide for all of the heart stuff they gave her, NDC/LOT/EXP: Unknown for Metoprolol or Cardiozyme. She clarifies that she takes Metoprolol normally every day that they have had her on that is extended release and she takes it at night. She says she had taken that at 09:30PM, and by the time she got there to the ER after midnight a little, they after gave her another to see if it would bring her heart rate down. She says that they kept her there a couple of hours, until her heart rate was normal, though her BP was up a bit. She says that they told her they could admit her but she said she would rather go home if they thought it was safe, and she went home. She says that her sister came home and stayed with her, whose husband is a cardiothoracic surgeon. Metoprolol: Caller says that the Metoprolol she is taking is in a pharmacy bottle that says use by 08Feb2022, it does not have an official label, the NDC or LOT are not on there. She says that they gave her 60 to take of regular Metoprolol, not extended release, which is 25mg to take twice a day by mouth, so 60 tabs and she would need to get refills as it is a months worth. Metoprolol extended release NDC/LOT/EXP not provided when queried. She clarifies that the not extended release is called Toprol/Metoprolol Tartrate 25mg. Caller says that her swelling lymph node limited the use of her arm, she can't pick up anything or lift her self up while moving in the bed, she is miserable, it hurts to put pressure on her arm and she can hold her arm up and move it around she can do anything with not holding anything, she feels a tightness there, even when she breathes or coughs. She says her left arm was sore initially for 3-4 days after getting the shot but the soreness left. She says she was told on 03Feb that she had swollen lymph nodes, which was two days after the shot, but she couldn't feel them then, she couldn't tell, and had no pain. She says it was two weeks later that happened, it was so odd that it was two weeks before it was hurting then got progressively worse. Caller says that Tuesday a week ago she thought she must have done weights with her arms since her muscles were sore, but it was only on one side and she hadn't done any exercise since after she went to the ER she was being careful what she did, and she thought she strained her arm and realized what it was, it has gotten progressively worse over the last week. She says last night she started looking up remedies, she has been putting ice on it, and the clinic said use warm, and she rubbed castor oil on it last night in the shower then this morning she massaged her arm with castor oil and put a warm wash cloth over it. She says that castor oil has anti inflammatory properties. She says she has not noticed a difference yet, but she has only done it two times. She says it also said she can take Aleve or Ibuprofen, they told her at the ER, they also started her on Eliquis the night she was there, which she had never been on, they didn't consider her A-f fib bad enough. She says that is what has her concerned, she got the shot then 6 days later A-fib made her feel like she couldn't breathe. She says also her BP and heart rate going back up made her sick to her stomach that subsided when her BP was coming down but then it started going back up again, when she went to the ER that Saturday night on the 6th but by the time she got there it was the 7th. Outcome of the events was unknown.; Sender's Comments: The possibility that suspect drug may have contributed to the reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,,,UNK,ELIQUIS,,Medical History/Concurrent Conditions: Atrial fibrillation,,,"['Abdominal discomfort', 'Anxiety', 'Atrial fibrillation', 'Blood pressure fluctuation', 'Blood pressure measurement', 'Bone pain', 'Breast pain', 'Disease recurrence', 'Ear disorder', 'Electrocardiogram', 'Headache', 'Heart rate', 'Heart rate increased', 'Lymphadenopathy', 'Mammogram', 'Pain in extremity', 'Syncope', 'Vaccination site erythema', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1100472,,61.0,F,"I had a stroke; This is a spontaneous report from a non-contactable Nurse. A 61-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3302), via an unspecified route of administration in left arm on 02Feb2021 at single dose for Covid-19 immunisation in hospital. Medical history included hypothyroid. Patient is not pregnant. Concomitant medication included levothyroxine, trazodone, famotidine (PEPCID), cyanocobalamin (VITAMIN B 12). The patient previously took codeine and experienced drug hypersensitivity. Historical vaccination included BNT162B2(lot number:EL3248) on 12Jan2021, in left arm, first dose. No other vaccine in four weeks. No Covid prior vaccination. The patient stated I don't know if it was a result of the Covid shot. But I don't have any comorbidities and I had a stroke on to four which was two days after the shot on 04Feb2021 09:30 with outcome of recovering (as reported). AE result in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization (2 days), disability or permanent damage. The patient underwent lab tests and procedures which included Nasal Swab, Covid test result: negative. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Despite insufficient clinical information provided, by close temporal relationship and absence of factors which may provide an alternative cause, the company deems there is a reasonable possibility that the reported stroke is related to the suspect drug Comirnaty. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,2.0,Yes,N,02/02/2021,02/04/2021,2.0,PVT,LEVOTHYROXINE; TRAZODONE; PEPCID [FAMOTIDINE]; VITAMIN B 12 [CYANOCOBALAMIN],,Medical History/Concurrent Conditions: Hypothyroidism,,,"['Cerebrovascular accident', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1100473,MI,57.0,M,"hearing loss; Ringing in ears; This is a spontaneous report from a contactable other hcp. A 57-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Jan2021 13:00 in left arm at single dose for covid-19 immunisation. Facility type vaccine was hospital. No other vaccine in four weeks. Medical history were none. No COVID prior vaccination. No COVID tested post vaccination. Known allergies: No known drug allergies (NKDA). Concomitant medication included omeprazole (PRILOSEC [OMEPRAZOLE]), zolpidem tartrate (AMBIEN CR), diazepam (DIAZEPAM) as needed. Historical vaccination included first dose of BNT162B2(lot number: ELO142) on 06Jan2021 01:00 PM in right arm for covid-19 immunisation. The patient experienced ringing in ears and hearing loss that is continually worsening on 29Jan2021 12:00 with outcome of not recovered. AE resulted in doctor or other healthcare professional office/clinic visit. it is unknown whether treatment was received.; Sender's Comments: Considering the plausible temporal association, and lacking any reported alternative explanations, a causative role of BNT162B2 vaccine for the reported worsening of ringing in ears and hearing loss cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/29/2021,2.0,PVT,PRILOSEC [OMEPRAZOLE]; AMBIEN CR; DIAZEPAM,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Deafness', 'Tinnitus']",2,PFIZER\BIONTECH, 1100477,TX,64.0,F,"dehydration; slight fever (99); chills; passed out in floor; sweating; Broke a tooth; Dizzy; Diarrhea; Super tired and went to bed by 8pm after COVID-19 vaccine; Arm was sore; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021 at 15:00, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. Patient did not have known allergies. Patient did not receive any other vaccine the same day and in four weeks. Patient did not have COVID-19 prior to vaccination. The patient experienced passed out in floor (medically significant) on 24Feb2021 at 10:30 PM, diarrhea (disability) on 24Feb2021, broke a tooth (medically significant) on 24Feb2021 at 10:30 PM, dehydration (disability) on 25Feb2021 12:00 AM, slight fever (99) (disability) on 25Feb2021 at 12:00 AM, chills (disability) on 24Feb2021 at 10:30 PM, super tired and went to bed by 08:00 PM after COVID-19 vaccine (non-serious) on 24Feb2021, arm was sore (non-serious) on 24Feb2021, sweating (non-serious) on 24Feb2021 at 10:30 PM, dizzy (non-serious) on 24Feb2021. No therapeutic measures were taken as a result of the events. Patient stated that all side effects resolved completely by 25Feb2021 evening, except for broke a tooth. Patient did not tested positive for COVID-19 post vaccination. The information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/24/2021,02/24/2021,0.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Dehydration', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Hyperhidrosis', 'Loss of consciousness', 'Pain in extremity', 'Pyrexia', 'Tooth loss']",1,PFIZER\BIONTECH, 1100478,,,F,"heart rate went ""really low"" / heart rate had gone down to 40-45; felt really weak; This is a spontaneous report from a contactable consumer. A 51-years-old female patient received bnt162b2 (BNT162B2) first dose, via an unspecified route of administration on 2021 at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced heart rate went ""really low"" / heart rate had gone down to 40-45 (medically significant) and felt really weak, both on an unspecified date with outcome of unknown. The patient underwent lab tests which included heart rate had gone down to 40-45, normal heart rate: around 70-80 on unknown date. Patient that she received her first dose of the Pfizer BioNTech COVID-19 vaccine about 3 weeks ago and was due to receive her second dose tomorrow. She experienced a ""weird side effect"" after her first dose: she stated her heart rate went ""really low"" and felt really weak. She stated that about 36 hours after receiving her dose, she checked her pulse and found her heart rate had gone down to 40-45. She stated her normal heart rate was around 70-80. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Asthenia', 'Heart rate', 'Heart rate decreased']",1,PFIZER\BIONTECH, 1100479,PA,85.0,F,"developed a rash; very itchy; She said she had the feeling of needles all over her entire body and face, along with a hot feeling; her neck, chest, and upper back are a purple-red color; difficulty seeing; macular degeneration; This is a spontaneous report from a contactable consumer (patient herself). An 85-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot# EN9581), via an unspecified route of administration on 20Feb2021 09:15 (at the age of 85-years-old) in right arm at single dose for covid-19 immunisation. Patient had allergies and asthma for years. There were no concomitant medications. Patient reported she got her first COVID-19 Vaccine on Saturday, 20Feb2021. She said she developed a rash on Monday (22Feb2021), and was very itchy. She said she didn't have the rash on her legs. She said she had the feeling of needles all over her entire body and face, along with a hot feeling on 22Feb2021. She said she was contributing her rash to the COVID-19 Vaccine. She asked if she got the second COVID-19 Vaccine, would the rash occur again, and would the rash be worse. The caller said she was scheduled to receive her second COVID-19 Vaccine dose on Thursday, 11Mar2021. The caller was advised she would be transferred to Pfizer Medical Information for further assistance. She had macular degeneration and had difficulty seeing in Feb2021. She clarified she felt like her face had needles going through it. She said her neck, chest, and upper back are a purple-red color on 22Feb2021. She said she was so uncomfortable that it was hard for her to wear clothes, and she had to sleep in the nude. Treatment: she was taking diphenhydramine hydrochloride (BENADRYL) and her daughter gave her an over-the-counter cortisone cream in a tube to use for her rash. She said she just started using the cortisone cream today (25Feb2021). She said she did not have the Benadryl and cortisone cream tube with her to provide the UPC/NDC Numbers, Lot Numbers, and Expiration Dates. She planned to call her doctor to see if he will give her something for the rash once she was finished speaking with Pfizer. The events did not require emergency room or physician office. Outcome of macular degeneration and difficulty seeing was unknown, and outcome of other events were not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/20/2021,02/01/2021,,PVT,,,Medical History/Concurrent Conditions: Allergy; Asthma,,,"['Erythema', 'Feeling hot', 'Macular degeneration', 'Pruritus', 'Rash', 'Visual acuity reduced']",1,PFIZER\BIONTECH, 1100480,PA,56.0,F,"annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonresponsive for a few moments/was asked a question and did not respond; sweats; high blood pressure; annoying pain; itching; hives on the arms and chest; Hot flashes; This is a spontaneous report from a contactable consumer (patient) A 56-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EN5318 at left arm on 16Feb2021 at SINGLE DOSE for covid-19 immunisation . Age at vacciantion 56 years.Vaccination Facility Type: Workplace Clinic. Medical history included ongoing allergies (5-10 years). She had a flu shot in Oct2020. There were no concomitant medications.Immediately after the vaccine she became nonresponsive for a few moments, broke out in sweats, had high blood pressure, annoying pain, and has been having itching and hives on the arms and chest.Clincal course was reported as follows: On 16Feb she had hot flashes,pruritus and blood pressure has not been right .On17Feb she developed annoying feeling in her chest.Then , it was added as follows: she received the first dose of the Covid-19 vaccine on 16Feb2021. She had an allergic reaction. The second dose was due 09Mar2020. She was under the impression that she has to take the vaccine she was told she needed a cocktail to get the shot.She had hot flashes and was itching. Her blood pressure has not been right. Her pressure was low then normal then high. She has an annoying feeling in her chest. The itching has stopped after she was medicated. She can't take Benadryl and she was given something else. She applied hydrocortisone cream and it helped. She had a flu shot in Oct2020. She went to the ER on 20Feb2021 because her blood pressure was spiking too high. She had an EKG which was normal. When she went to the ER her blood pressure was 167/100. Yesterday her blood pressure was 167/102. She was nervous about taking the second dose. Her blood pressure usually ranges from 119-120. It was off the charts at 130/80 and 150/99. Pateint was treated for pruritus.She was wondered if she can get the second dose .Events reported as non serious.Lab data included:EKG on20Feb2021:normal.Blood pressure measurement (16Feb2021): has not been right. Her pressure was low then normal then high , blood pressure measurement: 167/100 on 20Feb2021 , blood pressure measurement: 167/102 on 24Feb2021.Patient's recovered from pruritus while the outcome of the other events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/16/2021,02/16/2021,0.0,WRK,,Allergy,,,,"['Blood pressure fluctuation', 'Blood pressure measurement', 'Chest discomfort', 'Electrocardiogram', 'Hot flush', 'Hyperhidrosis', 'Hypersensitivity', 'Hypertension', 'Pain', 'Pruritus', 'Unresponsive to stimuli', 'Urticaria']",1,PFIZER\BIONTECH, 1100481,NY,56.0,F,"Lymphocyte abnormal; Neutrophil count abnormal; This is a spontaneous report from a contactable nurse (patient). This 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EN9581, Expiration Date: 31May2021) via intramuscular at single dose in deltoid left 30Jan2021 08:30 for COVID-19 immunization. The first dose was on 08Jan2021 at about 4:30 pm (Lot#: EL3246, Expiration Date: 30Apr2021) via intramuscular at single dose in deltoid left. Medical history was none. There was no additional vaccines administered on same date of the pfizer suspect. Prior vaccinations (within 4 weeks) was none. Concomitant medication was not reported. Patient stated she received both doses of the vaccine. She had blood work done afterwards and her neutrophil count and lymphocytes were abnormal on 20Feb2021. Patient asked if that was a normal response to getting the vaccine, if this was related to the COVID-19 vaccine. At this time, since she didn't know if it was related to the vaccine or not and if it was something to be concerned with, she would consider the events to be medically significant. She believed it was something to look into. Results of tests and procedures on 20Feb2021 included: lymphocyte percentage (normal range 20-50) was 54.8%; lymphocyte count 2.8, which was in the normal range; neutrophil percentage (normal range 50-70) 37.8%; neutrophil count (normal range 2-7.5) 1.9 mm; WBC 5.0. Patient also mentioned a test ""hydrochroma"", but she didn't print the results out. She has never heard of it before. Her level was like 1. The outcome of events was unknown.; Sender's Comments: The possibility that suspect drug may have contributed to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,02/20/2021,21.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Investigation', 'Lymphocyte count', 'Lymphocyte count abnormal', 'Lymphocyte percentage', 'Neutrophil count', 'Neutrophil count abnormal', 'Neutrophil percentage', 'White blood cell count']",2,PFIZER\BIONTECH,OT 1100482,MD,46.0,F,"Throat swelling; severe allergic reaction to the Pfizer vaccine; chills; sweats; nausea; This is a spontaneous report from two contactable physicians. A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267), via an unspecified route of administration on 13Feb2021 at a single dose in left arm for COVID-19 immunization. Medical history included herpes Simplex I, back pain, SI joint dysfunction, difficulty sleeping and allergy to raw tomatoes. The patient's concomitant medications were not reported. On 13Feb2021, the patient experienced throat swelling, severe allergic reaction to the Pfizer vaccine, chills, sweats, nausea, the seriousness of throat swelling, severe allergic reaction was reported as hospitalization, seriousness of the other events was reported as medically significant. Under anaphylaxis that the patient has EpiPen at home for raw tomatoes Clinical course: she had a severe reaction to the first shot presenting the following side effects: chills, sweats and nausea within 5 minutes and then developed throat swelling within 10 minutes, the patient was administered with an EpiPen, Benadryl and was sent to the ER where she received Benadryl IV monitored, eventually her symptoms diminished from 10 of 10 to a 6 in a scale of 10, the patient also received Prednisone 40 mg everyday for 4 days. She did have nausea and sweats. It was six out of ten in the ER. Then it went to four or five out of ten. It took four to five days to get back to normal. By five days after the vaccination she was back to normal. She had a virtual visit with a patient who apparently had a severe reaction after the first vaccine. It was set up in physical therapy office. HCP wants to know if it is safe for the patient to receive the second dose of the vaccine. HCP mentioned that this is her first patient who has a severe allergic reaction to the Pfizer vaccine. She was feeling better. She was told to call her doctor about getting the second shot. The bottom line is if they acted as severely as they did she would think the answer would be not to get the second. She was better. She felt fine. She has an allergy to raw tomatoes. She knows she is not supposed to have raw tomatoes. A couple of days ago she had a dressing that must have had raw tomatoes in it because she had throat swelling. The patient said what happened with Pfizer was more. She knew it when it was happening because it has happened before. She had no hypoxia. The patient reported that her pulse ox was checked and was in the high 90's. The patient was able to swallow. No drooling. She did have nausea and sweats. It was six out of ten in the ER. Then it went to four or five out of ten. It took four to five days to get back to normal. By five days after the vaccination she was back to normal. On 23Nov2020, the patient weighed 150 pounds and her height was 66 inches. The outcome of events was recovering. There is a causality, because it happened with 5 to 10 minutes after receiving the vaccination. She had to wait for 15 minutes. The patient had chills, sweats, and nausea within 5 minutes. She felt fine upon immediately receiving and then within 5 minutes she had chills, sweat, nausea, headache. Then within 5 to 10 minutes throat swelling. There is a causality, because it happened with 5 to 10 minutes after receiving the vaccination. She had to wait for 15 minutes. The patient had chills, sweats, and nausea within 5 minutes. She felt fine upon immediately receiving and then within 5 minutes she had chills, sweat, nausea, headache. Then within 5 to 10 minutes throat swelling.; Sender's Comments: Based on known safety profile and temporal association, the contribution of the suspect drug to the onset of events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,N,02/13/2021,02/13/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Back pain; Difficulty sleeping; Food allergy; Herpes simplex iridocyclitis; Joint dysfunction,,,"['Body height', 'Chills', 'Hyperhidrosis', 'Hypersensitivity', 'Nausea', 'Pharyngeal swelling', 'Weight']",1,PFIZER\BIONTECH, 1100483,,73.0,F,"L arm/hand numbness; blood pressure abnormality; chest pain; respiratory distress; This is a spontaneous report from a non-contactable other-HCP. This other HCP reported for a 73-Years-Old (same age at vaccination) female patient that she received the first dose of bnt162b2 (BNT162B2, Lot number EN6205), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medication was none. She had not been back to her pcp for ""several years"". No known history of HTN. She did have a blood pressure cuff at home. During her 15-minute waiting period after the injection on an unspecified date, the patient began to experience L arm/hand numbness. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, chest pain, rapid progression of symptoms and respiratory distress. Treatment included: no therapy. Follow up response was excellent. Patient discharge: stable to go home and follow up with PCP. Outcome of events was unknown. No follow-up attempts are possible. No further information expected.; Sender's Comments: Based on the information provided, and on a close drug-event temporal association, the Company assessed there was a reasonable possibility that the reported serious events were related to the suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Blood pressure abnormal', 'Blood pressure measurement', 'Chest pain', 'Hypoaesthesia', 'Respiratory distress']",1,PFIZER\BIONTECH, 1100484,FL,80.0,M,"until the vein opened up and was squirting out blood; until the vein opened up and was squirting out blood; a severe itching rash; This is a spontaneous report from a contactable consumer. An 80-year-old male patient (reporter husband) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on 29Jan2021 12:00 at SINGLE DOSE in left arm for COVID-19 immunisation. Medical history included ongoing asthma Onset Date: Probably about 20 years ago, ongoing chronic obstructive pulmonary disease Onset Date: Probably about 20 years ago, ongoing overweight Illness/AE: Little overweight. There was none family medical history relevant to AEs. There were no concomitant medications. The patient received first dose of bnt162b2 (Lot number: EC3246) on 08Jan2021 in Left arm for COVID-19 immunization. The patient experienced a severe itching rash on 01Feb2021 with the outcome not recovered. Area where a vein is very close under the skin itching that he scratched until the vein opened up and was squirting out blood on 24Feb2021 with unknown outcome. The rash hasn't gotten worse, and it is staying the same. The AEs require a visit to: Emergency Room and Physician Office. The patient underwent lab tests and procedures which included biopsy: unknown results on 25Feb2021, Bloodwork: Nothing showed up on this test. This is a non-serious report. The outcome of event a severe itching rash was not recovered, outcome of the other events was unknown. This consumer reported she and her husband were administered second dose of Pfizer COVID-19 Vaccine on 29Jan2021. Her husband apparently has had a reaction of very itchy rash to the Pfizer COVID-19 Vaccine. She reported that the patient saw the Dermatologist and the Dermatologist thinks the Reaction of very itchy rash is a reaction to the Pfizer COVID-19 Vaccine. Regarding testing/investigations related to this report caller provided that the primary care physician ordered bloodwork and nothing showed up in that. Biopsy was taken 25Feb2021 to see if reaction of very itchy rash is related to the Pfizer COVID-19 Vaccine When queried if any adverse event required Emergency room visit, physician's office visit or hospitalization caller reported that the patient was seen in the emergency room, but not admitted to the hospital on 24Feb2021 related to patient's event of area where a vein is very close under the skin itching that he scratched until the vein opened up and was squirting out blood event-they got that situated in the emergency room. Emergency room staff were the ones that recommended that the patient start Claritin. Dermatologist office visit was regarding the reaction of very itchy rash. The patient is taking Claritin and using Calamine lotion or Calamine spray for these events. Reaction assessed: Reaction of very itchy rash, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/01/2021,3.0,OTH,,Asthma (Onset Date: Probably about 20 years ago); COPD (Onset Date: Probably about 20 years ago); Overweight (Illness/AE: Little overweight),,,,"['Biopsy', 'Blood test', 'Haemorrhage', 'Rash pruritic', 'Scratch']",2,PFIZER\BIONTECH, 1100486,,,M,"tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer. A male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunisation. Patient received the Pfizer-BioNTech COVID-19 Vaccine first dose but tested positive for COVID-19. Wanted to know if it is okay to get the second dose tomorrow, as scheduled or do they have to wait. Outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1100488,MD,54.0,F,"increased AFib episodes; joint ache esp to left knee with pain; Headache; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration at arm left on 28Jan2021 at 11:00 (at the age of 54-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included atrial fibrillation (AFib), depression, aortic stenosis and allergy to sulfa, all from an unknown date and unknown if ongoing. Concomitant medication included losartan, HCTZ, sertraline hydrochloride (ZOLOFT), vitamin D3, magnesium and cyanocobalamin (VITAMIN B12). The patient previously took LEVOQUIN and prednisone and experienced allergies. On 02Feb2021 at 08:00, the patient experienced increased AFib episodes, joint ache esp. to left knee with pain and headache. The patient underwent lab tests and procedures which included SARS-COV-2 (nasal swab) test: negative on 22Feb2021. Therapeutic measures were taken as a result of the events and included acupuncture and the events required physician office visit. The patient outcome of the event was not recovered.; Sender's Comments: There is not a reasonable possibility that event atrial fibrillation is related to BNT162B2. The event only occurred 4 days after vaccination. And the patient had underlying atrial fibrillation, which is considered the most likely cause of the reported event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/02/2021,5.0,PVT,LOSARTAN; HCTZ; ZOLOFT; VITAMIN D3; MAGNESIUM; VITAMIN B12 [CYANOCOBALAMIN],,Medical History/Concurrent Conditions: AFib; Aortic stenosis; Depression; Sulfonamide allergy (known allergies: Sulfa),,,"['Arthralgia', 'Atrial fibrillation', 'Headache', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1100489,NY,29.0,F,"pericarditis; pericardial effusion; Severe inflammation; high white blood cell count; lymphadenopathy; trouble breathing; bibasilar atelectasis worsened with time after vaccine; This is a spontaneous report from a contactable other health professional reporting for herself. A 29-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262), via an unspecified route of administration on 23Jan2021 07:45 on left arm at single dose for COVID-19 immunization. Facility type Vaccine was at Pharmacy or Drug Store. Medical history included sickle cell trait, past history of thyroid cancer and Grave's disease. No known allergies. Concomitant medications included colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12), Thyroid medication and other unspecified medications. The patient experienced severe inflammation, high white blood cell count, lymphadenopathy, pericarditis, pericardial effussion, trouble breathing, bibasilar atelectasis worsened with time after vaccine on 24Jan2021 12:00. Went three times to ER and third time was to critical care and was on observation and heart monitors for over 24 hours. The events were resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Lab data included negative Covid PCR test (Nasal Swab) on 26Jan2021 and on 12Feb2021. Treatment was received for the events including killers, NSAIDS, antibiotics. The outcome of the events were resolving.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/23/2021,01/24/2021,1.0,PHM,VITAMIN D [COLECALCIFEROL]; VITAMIN B12 [CYANOCOBALAMIN],,Medical History/Concurrent Conditions: Graves' disease; Sickle cell trait; Thyroid cancer,,,"['Atelectasis', 'Dyspnoea', 'Inflammation', 'Lymphadenopathy', 'Pericardial effusion', 'Pericarditis', 'SARS-CoV-2 test', 'White blood cell count', 'White blood cell count increased']",1,PFIZER\BIONTECH, 1100490,PA,38.0,F,"had some delirium; fever of 100.0; Arm and shoulder pain; Arm and shoulder pain; fatigue; dizziness; nausea; mild diarrhea; achiness; headache; This is a spontaneous report from a Pfizer sponsored program- Company Information via contactable consumer. A 38-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection, Lot no. EL9269), via an unspecified route of administration on 12Feb2021 19:30 at single dose, covid-19 immunisation. Anatomical Location was left arm. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot no: EL8982, Anatomical Location: left arm) on 22Jan2021 08:00 PM. Medical history included allergies (allergies: Some antibiotics), PTSD, anxiety, possible IBS, irregular heartbeat at times. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) and fluoxetine. On 13Feb2021 01:15 AM, patient experience arm and shoulder pain, fatigue, fever of 100.0, dizziness, mild nausea and diarrhea, achiness, headache and had some delirium with fever, patient think it was related to her PTSD as well and not just the fever. Patient not had COVID prior vaccination. Patient was not tested COVID post vaccination. The outcome of the event was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,PVT,PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; FLUOXETINE,,Medical History/Concurrent Conditions: Allergy (Known allergies: Some antibiotics); Anxiety; Heartbeats irregular (irregular heartbeat at times); Irritable bowel syndrome (possible IBS); Post-traumatic stress disorder (PTSD),,,"['Arthralgia', 'Delirium', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH, 1100493,PA,83.0,M,"its bluish in color and it looks like there is bleeding under the skin; noticed his reaction/an area on the inside of his right thigh that looks like a hematoma; he has like a hematoma almost like a discoloration of the skin on the inside of his thigh/purplish color, like a bluish reddish but it is not red.; rash on the inside of his thigh. He clarifies well it is not a rash it is more like a hematoma; This is a spontaneous report from a contactable consumer (patient himself). An 83-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EN6198), via an unspecified route of administration on the left arm, first dose at age 83 years, on 25Feb2021 at single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. Patient stated that he got the Pfizer COVID 19 Vaccine yesterday (25Feb2021) at noon and this morning (26Feb2021), he has a rash on the inside of his thigh. He clarifies well it is not a rash it is more like a hematoma, almost like discoloration of the skin, it doesn't hurt but he wants to see if this is something that normally occurs. He showered last night and didn't notice it until this morning. He only noticed it about a half hour ago so he is not sure if there is any difference. He clarifies the area on the inside of his thigh is a purplish color, like a bluish reddish but it is not red. It looks like a hematoma, like bleeding under the skin. There is no swelling, it is not raised and it doesn't hurt to touch, just there. He didn't call his primary about this. He got this information so his doctor does not know anything about it. If it is something to be concerned about he will run down to the emergency room but he will see if he can find the office contact info. Outcome of the events was not recovered. Case was reported as non-serious.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/25/2021,02/26/2021,1.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Haematoma', 'Haemorrhage subcutaneous', 'Rash', 'Skin discolouration']",1,PFIZER\BIONTECH, 1100494,TN,79.0,U,"headache; Chills; Jaw pain; Tiredness; Nausea; Vomiting; was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; stress on my heart; have no energy and I cannot breath and it is just that I have not energy now; I cannot breath; This is a spontaneous report from a contactable consumer (patient). A 79-year-old patient of an unspecified gender received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL3246; expiration date: unknown) at 79-year-old vaccination age via an unspecified route of administration on 05Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient reported getting both the shots of the vaccine (COVID Vaccine) and the patient was still having a lot of symptoms that the patient should not be having like headache, chills, jaw pain, tiredness, nausea and vomiting which the patient had both of them in both shots and the patient also have been in the hospital with this. The patient had bad, bad jaw pain. The patient had the first shot on 05Jan2021 and had the problems since then, and then the patient got the second shot on 26Jan2021 and it got worse. The patient reported having several doctors which includes a cardiologist and stomach doctor. They did several tests (2021), the patient was bleeding, stool was black from blood, and the patient was vomiting blood. The patient reported that ""I had stress on my heart and I did not have a heart attack but I had stress on my heart."" The patient mentioned having no energy and the patient cannot breath and it is just that the patient having not energy now. When the patient was in the hospital, they gave the patient some medications and the patient don't have it in front of the patient. The outcome of the events was unknown.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/05/2021,,,UNK,,,,,,"['Asthenia', 'Cardiac discomfort', 'Chills', 'Dyspnoea', 'Fatigue', 'Haematemesis', 'Haemorrhage', 'Headache', 'Laboratory test', 'Melaena', 'Nausea', 'Pain in jaw', 'Vomiting']",1,PFIZER\BIONTECH, 1100495,NM,19.0,F,"1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, and hands; 1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, and hands; increase SOB; tightness chest; facial swelling; eye redness; flushing; This is a spontaneous report from a contactable Pharmacist. A 19-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number EN6198,) via intramuscular route of administration on 29Jan2021 at 24:00 SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's family medical history included sports induced asthma and gallstones from an unknown date and unknown if ongoing. The patient experienced 15:30 approximately 10 minutes after receiving vaccine patient reported and had notable facial swelling, eye redness and flushing on 19Feb2021 at 15:15. The patient underwent lab tests and procedures which included blood pressure measurement: 118/86, heart rate: 100, Respiratory rate: 18, oxygen saturation: 96 % and blood pressure measurement: 112/82, heart rate: 123, Respiratory rate: 18, oxygen saturation: 98 % an unspecified date. The events were assessed as non-serious by the reporter. The patient received treatment with 0.15 Epinephrine IM via home Epi- Pen self-delivered by patient's mother. The outcome of the events as unknown. No further follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the strong temporal relationship, the association between the onset of throat irritation, pruritus, dyspnea, chest discomfort, swelling face, ocular hyperemia and flushing and administration of vaccine cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/19/2021,02/19/2021,0.0,OTH,,,Medical History/Concurrent Conditions: Allergy NOS; Asthma; Fish allergy; Gallstones,,,"['Blood pressure measurement', 'Chest discomfort', 'Dyspnoea', 'Flushing', 'Heart rate', 'Ocular hyperaemia', 'Oxygen saturation', 'Pruritus', 'Respiratory rate', 'Swelling face', 'Throat irritation']",2,PFIZER\BIONTECH,OT 1100496,,,M,"hernia; anemia; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer sponsored program. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got his first dose but then was diagnosed with a hernia and had to have emergency surgery with a blood transfusion for anemia. Therapeutic measures were taken as a result of hernia which included surgery and anemia which included blood transfusion. The patient's second dose was due today and the reporter asks if he should get it or if should be delayed due to getting transfusion. The outcome of the events was unknown. Information on Lot/Batch has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Anaemia', 'Hernia']",1,PFIZER\BIONTECH, 1100497,IN,31.0,F,"the 2nd Pfizer-BioNTech COVID-19 vaccine was administered on 17Feb2021, she tested positive for COVID-19 on 22Feb2021/chills, fever, fatigue, headache/exposed to COVID between her 1st and 2nd vaccine; the 2nd Pfizer-BioNTech COVID-19 vaccine was administered on 17Feb2021, she tested positive for COVID-19 on 22Feb2021/chills, fever, fatigue, headache/exposed to COVID between her 1st and 2nd vaccine; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A 31-year-old female patient started received her first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283 and EN6200), via an unspecified route of administration on 27Jan2021 and on 17Feb2021 both at SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. A patient completed her vaccination schedule, the 2nd Pfizer-BioNTech COVID-19 vaccine was administered on 17Feb2021, she tested positive for COVID-19 on 22Feb2021, asks if a COVID infection may have a negative impact on the vaccine efficacy. Patient had (COVID-like) symptoms for 48 hours after her 2nd vaccination, her husband was exposed to COVID-19 on 14Feb2021 and tested positive on 20Feb2022. She received a positive test result on 22Feb2021, considers she was exposed to COVID between her 1st and 2nd vaccine doses. The patient clarified that her symptoms were fever, chills, headache, and fatigue on the eighteenth through the nineteenth. The patient underwent lab tests and procedures which included covid-19: positive and RTPCRt: positive on 22Feb2021. Outcome of the events was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/17/2021,02/22/2021,5.0,PVT,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1100498,GA,77.0,M,"hearing loss; This is a spontaneous report from a contactable consumer reporting for self. A 77-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via an unspecified route of administration in right arm on 08Feb2021 (Age at Vaccination was 77 years old) 13:00 at single dose for covid-19 immunisation. The patient medical history was not reported. Patient stated overall in good health. Concomitant medication included finasteride, gabapentine. From 11Feb2021 12:00, patient almost a total hearing loss right ear. He wore hearing aids and they were checked to be working properly. He was concerned about this hearing loss and went to urgent care today. He was given a prescription for PredniSone and also a prescription for Neomycin- Polymyxin-hc (ear drops). 2- For the first time in 77 years, he had been given a prescription for glasses this week. Outcome of event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/11/2021,3.0,UNK,FINASTERIDE; GABAPENTINE,,,,,['Deafness'],1,PFIZER\BIONTECH, 1100499,TX,78.0,M,"tested positive for the COVID-19 virus; tested positive for the COVID-19 virus; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information team. A 78-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9269, expiration date was unknown), via an unspecified route of administration on the right arm on 04Feb2021 at 15:00 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital; the vaccine was not administered at a military facility. The patient's medical history and concomitant medications were not reported. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on the same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). The patient tested positive for the COVID-19 virus on 22Feb2021. The patient requested guidance on when to receive his second dose. The patient stated he was scheduled to get his second COVID-19 vaccine shot on 02Mar2021 and asked if he should get the second COVID-19 vaccine shot, since he tested positive for the COVID-19 virus. He had a COVID-19 virus nasal swab test administered on 22Feb2021 that provided almost an immediate positive result. He clarified he had gone to an emergency care clinic for his COVID-19 virus test. He was prescribed some medication after he was diagnosed with the COVID-19 virus. He said he did not have all the medications with him as he was on his way to the emergency clinic to be retested for the COVID-19 virus. He stated he was prescribed a liquid cough medicine, promethazine 6.25-15mg/4/5ml. He said he did take promethazine liquid cough syrup. He said he was also prescribed prednisone 20 mg tablets, and that he was taking the prednisone 20 mg tablets twice a day. He was also prescribed an albuterol sulfate inhaler (NDC Number: 0093-3174-31; lot number: DAF07A, and expiration date: Aug2022) to use every 4 hours, as needed. He said the albuterol sulfate inhaler seemed to help. He also reported that his girlfriend had an extra (new and unopened) azithromycin (Z-PAK) that he took when he first started feeling bad. He said he took his girlfriend's Z-Pak at 2 tablets the first day, and 1 tablet a day for 4 days from an unspecified date in Feb2021 and completed that. The adverse event did not require a visit to a physician office. The patient underwent lab tests and procedures, which included COVID-19 virus test: positive on 22Feb2021. Therapeutic measures were taken as a result of the event ""tested positive for the COVID-19 virus."" The outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/04/2021,02/22/2021,18.0,PVT,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1100500,WI,76.0,M,"symptoms of bell palsy; Numbness of upper and lower lip on right side.; sore muscles in neck; sore muscles in neck and shoulder; watery eyes; muscle aches; pains; problems in sleeping; This is a spontaneous report from a contactable consumer via the Pfizer sponsored program. This is a spontaneous report from a contactable consumer (the patient). A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264), via an unspecified route of administration, in the left arm on 01Feb2021 at 14:30 (at the age of 76-years) as a single dose for COVID-19 immunization. Medical history included chronic asthma, nasal polyps, vestibular schwannoma, alopecia, gastrooesophageal reflux disease. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021 at 07:00 AM, the patient experienced symptoms of bell palsy, numbness of upper and lower lip on right side, sore muscles in neck and shoulder, watery eyes, muscle aches, pain, problems in sleeping. He felt the symptoms after the first dose. The patient visited the emergency room/ department or urgent care due to the events. The patient did not received treatment for the events. The clinical outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/23/2021,22.0,PVT,,,Medical History/Concurrent Conditions: Alopecia; Asthma chronic (chronic asthma-controlled); GERD; Nasal polyps; Vestibular schwannoma,,,"['Arthralgia', ""Bell's palsy"", 'Hypoaesthesia oral', 'Insomnia', 'Lacrimation increased', 'Myalgia', 'Neck pain', 'Pain']",1,PFIZER\BIONTECH, 1100501,MN,94.0,M,"started him on his oxygen; O2 went from 85 to 98; bp 155; notably shuffled; became non-responsive; looks like he is having a stroke; This is a spontaneous report from a contactable consumer (patient's daughter). A 94-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 25Feb2021 13:45 (at 94-year-old) at single dose (Arm Right) for COVID-19 immunization. Vaccination facility type is clinic. Medical history included congestive heart failure, early stages dementia. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 04Feb2021 (at 93-year-old) on right arm for COVID-19 immunization. The patient had no covid prior vaccination. Patient has no known allergies. The patient (father) seemed to be doing fine until 19:45 on 26Feb2021 roughly 30 hours after vaccination. He has early stages dementia, so if he was feeling ill he didn't report anything, and they didn't notice anything. He got up from the table, notably shuffled the 10 feet to the bathroom, sat down on the toilet before we could ""pull down his pants"", and then became non-responsive. The reporter said to her son it looks like he is having a stroke. They got him onto the floor. started him on his oxygen concentrator (usually used only at night), O2 went from 85 to 98; bp 155 from an unspecified date. after a while he came to. he is dnr, dni, so they didn't call an ambulance. Eventually they got him up. no signs of stroke. He does have congestive heart failure. This has never happened before, and he has no history of falling. Daughter was reporting the next morning. He has not yet been awake since this occurred. it is now 8am 27Feb2021. Covid was not tested post vaccination. The outcome of the event o2 went from 85 to 98 was recovered, while for other events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/25/2021,02/26/2021,1.0,OTH,,,Medical History/Concurrent Conditions: Congestive heart failure; Dementia,,,"['Blood pressure measurement', 'Cerebrovascular accident', 'Gait disturbance', 'Hypertension', 'Oxygen saturation', 'Oxygen saturation decreased', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH, 1100502,TX,60.0,M,"fatigue; problems with his gall bladder; 2nd day joint pain; First day sore arm; slight headache/headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration at the age of 60-year-old at left arm on 23Feb2021 08:15 at single dose for COVID-19 immunization. Medical history included heart failure, sarcoidosis and psoriatic arthritis. The patient wasn't allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced sore arm and slight headache in first day on 23Feb2021 09:00, joint pain in 2nd day on 24Feb2021, headache and fatigue and problems with his gall bladder in 3rd day on 25Feb2021. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient wasn't received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There wasn't treatment received for the adverse event. The outcome of events was recovered in Feb2021. This report was reported as non-serious report. No seriousness criteria was reported: no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/23/2021,0.0,PVT,,,Medical History/Concurrent Conditions: Heart failure; Psoriatic arthritis; Sarcoidosis,,,"['Arthralgia', 'Fatigue', 'Gallbladder disorder', 'Headache', 'Pain in extremity']",UNK,PFIZER\BIONTECH, 1100508,,,F,"AFib; major side effects at the injection site, her left arm swelled up it got hard and red; major side effects at the injection site, her left arm swelled up it got hard and red; left arm still itchy; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. An 84-year-old female patient (mother) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 22Feb2021 at a single dose for COVID-19 immunisation. Medical history included hives or redness to unspecified medicines in the past. The patient's concomitant medications were not reported. The reporter stated that her mother received the first dose of COVID-19 vaccine this Monday (on 22Feb2021) she is 84 years old and she has AFib (unspecified date). The patient has major side effects at the injection site, her left arm swelled up it got hard and red on unspecified date. The reporter asked if it is common/normal that the patient's left arm still itchy after six days. The patient previously experienced hives or redness to unspecified medicines in the past. The reporter wanted to know if the patient should get the second dose as scheduled. Outcome of the events were unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,,,UNK,,,Medical History/Concurrent Conditions: Hives (to unspecified medicines in the past); Redness (to unspecified medicines in the past),,,"['Atrial fibrillation', 'Pruritus', 'Vaccination site erythema', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 1100509,GA,77.0,F,"Seizure; Could not move nor speak; Could not move nor speak; Chills; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021 at 10:00, at single dose, for COVID-19 immunisation. Medical history included mitral valve prolapse and ongoing food allergy (to cantaloupe). Patient did not have COVID-19 prior to vaccination. Concomitant medications included vitamin b complex (B COMPLEX) and calcium carbonate, colecalciferol (CALCIUM + D3). Patient did not receive other vaccine in four weeks. The patient experienced seizure (medically significant) on 27Feb2021 at 02:00 AM with outcome of recovered in 2021, could not move nor speak (non-serious) on 27Feb2021 at 02:00 AM with outcome of recovered in 2021, could not move nor speak (non-serious) on 27Feb2021 at 02:00 AM with outcome of recovered in 2021, chills (non-serious) on 27Feb2021 with outcome of recovered in 2021. No therapeutic measures were administered as a result of the events. Clinical course: the patient reported that she had been having chills for several hours. During the night while sleeping, she believe she had a seizure. She was awakened with her body quivering from head to toe. She had no pain. She was aware of what was happening. She could not move nor speak. The event did not last very long and, when the quivering ceased, she no longer had chills. Patient did not test for COVID-19 post vaccination. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/24/2021,02/27/2021,3.0,PHM,B COMPLEX [VITAMIN B COMPLEX]; CALCIUM + D3 [CALCIUM CARBONATE;COLECALCIFEROL],Food allergy (To cantaloupe),Medical History/Concurrent Conditions: Mitral valve prolapse,,,"['Chills', 'Movement disorder', 'Seizure', 'Speech disorder']",1,PFIZER\BIONTECH, 1100510,OH,95.0,F,"heart attack; became ill; I became nauseous; vomiting; dry heaves; dizzy; tingling in my face and right hand; right hand didn't feel like I could get up on my own; This is a spontaneous report from a contactable consumer. A 95-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 10Feb2021 10:15 at SINGLE DOSE in left arm for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) with lot number: EL3249 on 20Jan2021 in right arm. After receiving the 2nd dose on 10Feb2021, the patient became ill on 11Feb2021, while sitting on the toilet, she became nauseous and vomiting repeatedly even dry heaves also then became dizzy and felt a tingling in my face and right hand didn't feel like the patient could get up on her own so the patient's son and daughter assisted her to her bed. She didn't know what was wrong and her daughter thought it was a side effect of the vaccine and called the nurse on call. After arriving at the emergency and was examined the patient was told she was being kept for observation since she had just had the vaccine. The patient was later told she also had a mild heart attack and to her knowledge I never had any heart issues. She could then no longer use her walker to walk because she couldn't bear weight on her right hand. She was hospitalized for 8 days and transferred to rehab and I'm still in rehab. The events were assessed as serious (hospitalized and disability). The outcome of the events was not recovered. The patient received treatment for the events.",Not Reported,,Not Reported,Yes,8.0,Yes,N,02/10/2021,02/11/2021,1.0,PVT,,,,,,"['Dizziness', 'Dysstasia', 'Malaise', 'Myocardial infarction', 'Nausea', 'Paraesthesia', 'Retching', 'Vomiting']",2,PFIZER\BIONTECH, 1100511,PA,32.0,M,"blacked out; Nausea; chills; sweating; muscle weakness; arm pain; fever; fell; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN5318) via an unspecified route of administration on Right arm, at the age of 32-year-old, on 27Feb2021 13:15, single dose, for covid-19 immunisation. Medical history included gastrooesophageal reflux disease. Concomitant medication included esomeprazole magnesium (ESOMEPRAZOLE [ESOMEPRAZOLE MAGNESIUM]) and garlic supplement. The patient previously took amoxicillin and experienced drug hypersensitivity and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6198) on 06Feb2021 13:15, at right arm, at the age of 32-year-old single dose for covid-19 immunisation. On 28Feb2021 at 04:00, 15 hours after the shot was administered, the patient experienced nausea, chills, sweating, muscle weakness, arm pain, fever, fell and blacked out twice. The patient did not receive any treatment in response to the events. The patient was not diagnosed with covid prior vaccination and was not tested for COVID post vaccination. Outcome of the events was recovering at the time of the report.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported loss of consciousness cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/27/2021,02/28/2021,1.0,WRK,ESOMEPRAZOLE [ESOMEPRAZOLE MAGNESIUM],,Medical History/Concurrent Conditions: Acid reflux (oesophageal),,,"['Chills', 'Fall', 'Hyperhidrosis', 'Loss of consciousness', 'Muscular weakness', 'Nausea', 'Pain in extremity', 'Pyrexia']",2,PFIZER\BIONTECH, 1100512,MA,78.0,M,"unable to stand; L shoulder/arm chest pain; arm pain; chest pain; significant dizzy spells; chills; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6203, expiry date not reported), via an unspecified route of administration on 26Feb2021 16:15 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease and coronary artery disease from an unknown date and unknown if ongoing. Concomitant medication included tamsulosin, metoprolol tartrate, atorvastatin calcium, rivaroxaban, cyanocobalamin (B12). The patient previously took levaquin and experienced allergies. The patient was 78-years-old when he received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9809, expiry date not reported) on 05Feb2021 16:15 on the right arm for covid-19 immunisation. The patient experienced unable to stand, L shoulder/arm, chest pain, arm pain, significant dizzy spells and chills on 27Feb2021 03:00 with outcome of recovered. The events resulted in emergency room/department or urgent care and hospitalization. The patient was hospitalized for the events for 2 days. The patient underwent lab tests and procedures which included chest x-ray: unknown results, electrocardiogram: unknown results, nitrate compound therapy: unknown results, sars-cov-2 test: negative on 27Feb2021. Therapeutic measures were taken as a result of the events. The patient recovered from the events on an unspecified date.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/26/2021,02/27/2021,1.0,PHM,TAMSULOSIN; METOPROLOL TARTRATE; ATORVASTATIN CALCIUM; RIVAROXABAN; B12 [CYANOCOBALAMIN],,Medical History/Concurrent Conditions: COPD; Coronary heart disease,,,"['Arthralgia', 'Chest X-ray', 'Chest pain', 'Chills', 'Dizziness', 'Dysstasia', 'Electrocardiogram', 'Nitrate compound therapy', 'Pain in extremity', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1100513,PA,65.0,F,"I have MS and after day 4 of the 2nd dose I haven't been the same.; This 65- year-old male patient contactable consumer (reported for himself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EL9264), via an unspecified route of administration, on 13Feb2021 at 11:00 AM as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a Nursing Home/Senior Living Facility. Historical Vaccine included first dose of BNT162B2 on 23Jan2021 for COVID-19 immunization, lot number 11:00 AM, in left arm. She has had no other vaccines on the same day or in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included: Multiple Sclerosis, colitis, gastroparesis, asthma, and allergy to Penicillins. Concomitant medications were not reported. It was also warm to the touch. On 17Feb2021, the patient reported that I have MS and after day 4 of the 2nd dose I haven't been the same. Pain throughout my body and extreme fatigue. All my MS issues were brought to light and haven't left. The outcome of the events Pain throughout my body and extreme fatigue/ MS issues were brought to light and haven't left was not recovered. It was reported that since the vaccination, the patient had been tested for COVID-19 via nasal swab on 19Feb2021 with a negative result.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/17/2021,4.0,SEN,,,Medical History/Concurrent Conditions: Asthma; Colitis; Gastroparesis; MS; Penicillin allergy,,,"['Multiple sclerosis', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1100514,FL,66.0,F,"covid-19 test (nasal swab) on 29Jan2021 and the result was positive; covid-19 test (nasal swab) on 29Jan2021 and the result was positive; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, the first dose on 24Dec2020 14:15 (lot number: EKT231) on the left arm, then the second dose on 14Jan2021 (lot number: unknown) on the left deltoid; both at a single dose for COVID-19 immunization. The patient experienced severe abdominal pain, clay colored stool, tea colored urine, intensely burning, exploding headache and productive cough after the first dose was administered on 24Dec2020. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient underwent covid-19 test (nasal swab) on 29Jan2021 and the result was positive. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/14/2021,01/29/2021,15.0,PVT,,,,,,"['COVID-19', 'SARS-CoV-2 test', 'Vaccination failure']",2,PFIZER\BIONTECH, 1100515,NY,39.0,F,"I got Covid two weeks after my first shot; I got Covid two weeks after my first shot; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231, first dose) solution for injection intramuscular on an unknown date (at the age of 39-years-old) at single dose for COVID-19 vaccination. Medical history included high blood pressure and prediabetic. Concomitant medication included losartan. The patient stated, ""I got Covid two weeks after my first shot."" The outcome of the event got Covid two weeks after my first shot was unknown. Note: In Material Information (CI grid), Material # and Material Description fields are applicable to non-SAP sites and will be blank on the report for investigation records created under SAP sites. Material # (SAP) and Material Description (SAP) fields are applicable to SAP sites and will be blank on the report for investigation records created under non-SAP sites. Investigation Decision: (Parent) FPRS Evaluation Comment: (Site name), reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number is valid and an investigation will be performed. Repeat Investigation?: No. Was CAPA Previously Identif'd?: No. Full Investigation Required?: Yes. CAPAs in Place?: N/A. CAPA Reference: N/A. Manufactured Post-CAPA: N/A. Reviewed By: (name). Reviewed On (GMT): 23Feb2021. QA Review & Rationale: The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect of lot EL9266 of the PFIZER-BIONTECH COVID-19 VACCINE. The initial scope of this investigation is limited to the reported finished goods lot EL9266 pending review of lot genealogy. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. Investigation findings: The initial scope of the investigation was limited to the reported finished goods lot. The final scope was expanded to include the reported finished goods lot EL9266, fill lot EL9257, and the formulated drug product lot EL9248. Manufacturing and packaging batch records were reviewed for the reported complaint lot. (Site name) QO did not receive photographs or a complaint sample for examination. The complaint was not confirmed. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The results of all analytical tests performed at the time of lot release confirmed that the batch continues to meet potency specifications. The product requires storage in ultra-low temperature freezers. A review of the temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. Regulatory / Market Assessment: NTM Decision: No-NTM not required. NTM Rationale: Other. Date NTM Decision Made (GMT): This should reflect the most current decision date 26Feb2021. Other NTM Rationale: This complaint is not confirmed or considered process related. Regulatory Impact: No. Other Regulatory Notification: N/A. AQRT/MACC Ref Number: N/A. Root Cause / CAPA: Process Related?: No. Final Confirmation Status: Not Confirmed. Vendor Related?: No. Root Cause Analysis/Identif: (Site name) Quality Operations could not indicate a probable root cause for the complaint to be related to the production process of the involved batch. Review of the manufacturing and packaging batch records and release test results confirmed that the batch continues to meet potency specifications. It is unknown how the product was handled, stored, or administered after it left the (Site name). Impact Analysis: Based on the results of this investigation, the manufacturing and packaging batches remain acceptable and the reported complaint is not representative of the lot. No regulatory notification is needed. Root Cause Category (Tier 1): Non-assignable (Complaint Not Confirmed). Contributing Factor (Tier 1): Non-assignable (Complaint Not Confirmed). Root Cause Category (Tier 2): Non-assignable (Complaint Not Confirmed). Contributing Factor (Tier 2): Non-assignable (Complaint Not Confirmed). Root Cause Category (Tier 3): N/A. Contributing Factor (Tier 3): N/A. Special or Common Cause: Common Cause Root Cause is always present to some degree in the process. Special Cause Root Cause is something different happening at a certain time or place in the process. Improve / control: Corrective / Preventive Action: There were no corrective actions as a result of this complaint investigation. The results of all tests, inspections, and in-process controls have been reviewed and all results met the established requirements prior to the release of the reported batch for distribution. Conclusion & Approvals: Additional Approval(s) Req'd?: No. Product Quality Impact: No. Market / Clinical Impact: No. SQRT Review Required?: No. Stability Impact: No. AQRT Review Req'd?: No. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9266 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL9266, fill lot EL9257, and the formulated drug product lot EL9248. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Scope of Compl. Investigation: The scope of this investigation included the reported finished goods lot EL9266, fill lot EL9257, and the bulk formulated drug product EL9248. Acceptable review of related documentation, including manufacturing batch records and review of release test results at the time of lot release confirmed that there were no issues which may have resulted in a complaint of this nature. Vendor Investigation?: No. Action Title / Short Descript.: N/A. Design Related?: Document Review Summary: DEVIATIONS: Complete - Acceptable There were no planned or unplanned deviations recorded during the manufacturing of the reported lot or associated batches that may have caused a complaint of this nature. MANUFACTURING BATCH RECORDS: Complete -Acceptable. The bulk manufacturing batch records for the complaint batch were reviewed as part of this investigation and were found to be acceptable. All processing steps were performed within pre-established parameters. The review of the manufacturing record confirmed that all in process checks, all line startup and end of batch challenges, and all line clearance and cleaning activities were completed satisfactorily. All raw materials used in the complaint batch were of the correct weight and identity. All the manufacturing temperatures mix speeds and mixing times were within acceptable ranges. In-process appearance and specific gravity test results were all within acceptable ranges. A review of the solution filtration documentation confirmed that all filters and Water for Injection (WFI) were used within their expiration dates, and that all the filtration times, pH results, and pressure specifications were met. The manufacturing processes of raw material usage, solution formulation and filtration were all found to be acceptable. All manufacturing parameters met established requirements. A log is maintained throughout the manufacturing process of the amount of elapsed time that the product is out of refrigeration. A review of the elapsed time tracking logs confirmed that all times were within allowable limits. PACKAGING BATCH RECORDS: Complete -Acceptable. The review of the packaging record confirmed that all in process checks, all line startup and end of batch challenges, and all line clearance and cleaning activities were completed satisfactorily. Audits are performed on the finished packaged units by Packaging Operations personnel at regular intervals throughout the final packaging process. This is done in order to ensure that all required labeling and packaging is present, complete, and meets all establishments requirements. During the audits, inspectors visually check the appearance of the finished product for defects. The Pfizer-BioNTech COVID-19 Vaccine vials are loaded into trays containing 195 vials each. Five trays are then banded together into a bundle. The vaccine requires ultra-low temperature freezer storage. Prior to loading, freezer temperatures were verified to between -67�C and -73�C. Freezer shelves were then loaded with bundles of product. During the freezing phase, which occurs 60 hours after loading, the temperature of the freezers is monitored. If the temperature is warmer than the previously recorded temperature, supervision is notified. Additionally, after the freezer temperature drops below -60�C, the temperature recorded may be warmer due to the freezer operation caused by the freezer cycling. This is acceptable. A review of the log for the reported batch confirmed that all freezer temperatures acceptable. Samples are then stored until the product is released for distribution. LOT HISTORY: Complete - Acceptable. The results of all tests and inspections met required specifications at the time of release for distribution on 31Jan2021 Reserve Sample Evaluation: Rsrv. Sample Evaluation Reqd?: No. Rsrv. Sample Eval. Rationale: Visual examination of a reserve sample would not be expected to indicate the potency of the drug product. A reserve sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months of the release date of the involved batch. The results of all analytical tests performed at the time of lot release were confirmed to be within registered specifications. All available stability results for this product were within registered specification and stability studies (including accelerated studies) are ongoing for this product. Confirmed Reserve Defect?: No. The complaint history for the reported PFIZER-BIONTECH COVID-19 VACCINE lot EL9266 was reviewed. As of 26Feb2021, there are a total of two complaints for this lot and classification. No lot specific trend was identified that would require additional investigation. Lot Trend Actions Taken: There were no lot trend actions taken as a result of this investigation.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,LOSARTAN,,Medical History/Concurrent Conditions: Blood pressure high (Verbatim: High Blood Pressure); Pre-diabetic (Verbatim: Prediabetic),,,"['Drug ineffective', 'Suspected COVID-19']",1,PFIZER\BIONTECH,OT 1100516,NH,45.0,F,"Had diarrhea on and off for two weeks; Felt like she had a tourniquet to her left arm/ Felt like she wasn't getting blood flow to her arm/feeling like she would pass out; Joint ache/little aches and pains to her joints; completely fatigued/Fatigue; Flu like symptoms/felt like she had the flu; Tachycardic, her heart rate was above 125; An autoimmune response affecting her autonomic nervous system/affecting her neurological system; Had unexplained neuropathy and she had full neuropathy in her toes and fingers; Felt like she has small fiber neuropathy; left arm and leg went numb/ numbness to her thigh and left bicep/ numb to both sides of her arms/Left arm and leg went numb/Neck and face got numb; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of bnt162b2 (lot: EK5730), via an unspecified route of administration in left arm on 24Dec2020 at single dose for covid-19 immunization. Medical history included Raynaud's syndrome (this is considered autoimmune, and she has had it maybe 15 years). There were no concomitant medications. Nurse calling as patient about Pfizer COVID-19 vaccine, and says her occupational health doctor has reported her experience to the CDC and FDA already. She says that she wasn't able to get a second dose injection. Weight was 129-130 lbs. Caller clarifies that her occupational health doctor had reported it to CDC and DPH. She says that she went to get the shot and didn't get a paper to say sign up for reaction stuff, she got the vaccine on Christmas Eve and then worked a bunch of days. She says they thought her symptoms would go away in a couple weeks, and when they didn't, her doctor reported her symptoms. She says that it started about 15 minutes after getting the vaccine, where they had her sit for 15 minutes after and a nurse checked her arm and said it was ok, and she told her that she feels ok and got up and left and got in the car with her husband who was driving. She says her left arm and leg went numb after she got in the car, so she told him don't leave since her left arm and leg were a bit numb so he pulled over into a parking lot. She says then her neck and face got numb, so she called her friend who is a nurse who said that it was not respiratory and not anaphylactic, maybe she is dehydrated since she worked last night so she ate and stayed close to the hospital. She says that if it was not Christmas Eve when they had so much to do, she would have went back in, but since she did not have shortness of breath or respiratory issues and had so much to do that day, she went about the day. She says she woke up the next day and her neck and face were completely numb, but she worked that night and told the resident there that said it might go away, and she was not having problems breathing. She says that a nurse said she had a reaction too, but the other nurse had a rash, and she didn't have a rash. Caller says on Monday she had the same numbness to her neck and face and ended up calling work health who said that the shot was so new, and everyone has different reactions, it should end up going away. She says that they did a COVID test because she had little aches and pains to her joints, but she also worked 12 hours Sunday. She says that they sent her for a COVID test which she went for on day 5 after getting the vaccine, which was Wednesday. She says she went in the morning and got the test at a testing tent then went home and was down and out with flu like symptoms, she couldn't get out of bed. She says that the test came back negative. She says that she had diarrhea now with her symptoms from the vaccine. She says she also had numbness to her thighs, after having it to her neck and face, then it moved to her thighs. She says for a couple days she could not get out of bed, she felt like she had the flu, but it was not the flu. She says her arms were numb, and on the 11th day after getting the vaccine she woke up and felt like she had a tourniquet to her left arm, that was on Sunday, it felt like she wasn't getting blood flow to her arm. She says she was numb to both sides of her arms, and her left arm felt like there was a tourniquet on it and felt like there was no circulation to her fingers and she couldn't feel her ring finger or middle finger on her left hand. She says she still had numbness to her thigh and left bicep, and she went to the emergency room at (Hospital name) where she works. She says she was not admitted to the hospital and was there about 6 hours. Caller says that all labs were normal at the ER that day, they did a MRI of her brain, cervical spine, and thoracic at (Hospital name). The Numbness treatment: Caller says that her primary care doctor tried to give her Gabapentin and told her to take 100 mg that night, and she could take it up to three times a day, and she took one dose that night that they prescribed it. She says she felt dizzy and decided not to take it again. Caller says she went to the emergency room again because she was completely fatigued, on day 19, she couldn't get out of bed and she talked to her doctor again and they said they don't know what happened to her body, so to see a neurologist in (Place name), which was impossible due to COVID they said they would see her in 4-5 months. She says she went to the ER at (Place name), and their neurologist said that her neuros were intact and couldn't explain her numbness, said that the vaccine was new, she was reacting to vaccine and they don't know what will happen with her symptoms. She says she was not admitted over night, she went home after 6 hours both times she went to the ER. Caller says she had diarrhea on and off for two weeks after getting the vaccine, she did no treatment, she had set up a telehealth appointment with a gastroenterologist, but she felt better so she canceled the appointment. She says her aches and pains to her joints, that only lasted a day or two, and also she worked 12 hours that day on her feet, so it could be from that, she now has no aches and pains in her joints. She says that the numbness hasn't gotten worse. She says on 28Jan she saw the neurologist in (Place name), and they felt like she had unexplained neuropathy and she had full neuropathy in her toes and fingers, then they did an EMG 08Feb. She says that she is still numb to her legs and arms, she still has feeling to the muscles, they did a pricking test and her arms and legs were numb but still had feeling, but her fingertips and toes lost feeling. She says her EMG was normal, but that only tests large muscle fiber. She says on 16Feb, she went to see her local rheumatologist Dr. (Name) out in (Place name). She says that they felt like she has small fiber neuropathy. She says that they did her orthostatic vitals, and she was so fatigued, with numbness to her arms, legs, face, and neck. She says during her ortho resting while standing she was tachycardia, her heart rate was above 125, and the doctor said that is not even you doing dishes, they are going with Hunts syndrome. She says that she thinks she is not gonna follow up with her, and is going to go to (Place name), the vaccine did something to her body, an autoimmune response affecting her autonomic nervous system, she was feeling like she would pass out laying down for 5 minutes and then sitting back up. She says she will see another neurologist at (Hospital name), and have someone who will think outside the box, and maybe eventually it will calm down. She says she still has the feeling like she will pass out when she stands up and has numbness to her arms and legs. She says a friend of hers recommended for her to call the number, that there are Pfizer doctors who might be able to explain something, she is not seeing the right doctor, she needs to see someone who does neuroimmunology, like at (Hospital name), it is affecting her neurological system, her local doctor she doesn't want to see her for vaccine reaction since they don't know. She says that she is hoping that someone will review this since she has no idea and it is not going away. She says she now has a (Hospital name) appointment on 10Mar with a neurologist. The outcome of the event Hypoaesthesia was not recovered, Diarrhea was recovering, Joint ache was recovered on unspecified date, other events was unknown.; Sender's Comments: Based on chronological connection to the vaccine, a causal relationship between events Neuropathy peripheral, Small fibre neuropathy and Hypoaesthesia and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/24/2020,12/24/2020,0.0,PVT,,,"Medical History/Concurrent Conditions: Raynaud's syndrome (this is considered autoimmune, and she has had it maybe 15 years)",,,"['Arthralgia', 'Diarrhoea', 'Electromyogram', 'Fatigue', 'Feeling abnormal', 'Heart rate', 'Hypoaesthesia', 'Influenza like illness', 'Investigation', 'Laboratory test', 'Magnetic resonance imaging', 'Magnetic resonance imaging head', 'Magnetic resonance imaging neck', 'Neurological symptom', 'Neuropathy peripheral', 'SARS-CoV-2 test', 'Skin test', 'Small fibre neuropathy', 'Tachycardia', 'Weight']",1,PFIZER\BIONTECH, 1100517,LA,70.0,F,"left arm pain; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EM, expiration date unknown) via an unspecified route of administration in the left arm on 05Feb2021 13:30 (at 70 years old) at a SINGLE DOSE for COVID-19 immunisation. The patient's medical history included bulging discs and known allergies to Penicillin, Dilaudid, and Sulphur. Concomitant medications included ascorbic acid (VITAMIN C), colecalciferol (D), biotin, calcium, magnesium, and curcuma longa (TURMERIC); all from an unknown date for unspecified indications. The patient received these medications within 2 weeks of vaccination. At 70 years old, the patient received the first dose of BNT162B2 (lot number: EM, expiration date unknown) via an unspecified route of administration in the left arm on 15Jan2021 11:30 at a single dose for COVID-19 immunisation and experienced pain in left knee and down to ankle and knee arthritic. The patient was not pregnant at the time of vaccination; was not diagnosed with COVID prior to vaccination; did not receive any other vaccines within 4 weeks prior to BNT162B2; and has not been tested for COVID post vaccination. It was reported that after the administration of the second dose, the patient experienced left arm pain on an unspecified date. Patient realized that the pain was akin to what she felt in knee (after the first dose) but not as bad. No treatment was received in response to the event. Outcome of the event was recovered with sequelae. The event was reported as disabling. Information on batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/05/2021,,,PVT,VITAMIN C [ASCORBIC ACID]; D; BIOTIN; CALCIUM; MAGNESIUM; TURMERIC [CURCUMA LONGA],,Medical History/Concurrent Conditions: Intervertebral disc bulging; Penicillin allergy,,,['Pain in extremity'],2,PFIZER\BIONTECH, 1100518,NC,,M,"Reporter could not wake patient up; Oxygen dropped; Not doing too good; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 Vaccine. Medical history included lung cancer (they just told him he has lung cancer), ongoing smokes (She reported that he still smokes). The patient's concomitant medications were not reported. Consumer reported her husband was administered the first dose of Pfizer COVID-19 Vaccine. He refused to take the second dose of Pfizer COVID-19 Vaccine because he is not doing too good; and because of the events he experienced after being administered the first dose of Pfizer COVID-19 Vaccine. She clarified that the events he experienced after being administered the first dose of Pfizer COVID-19 Vaccine included: Right after the first dose of the vaccine was administered she does not know what happened but his oxygen dropped; that happens too because he won't wear his oxygen like he should; but reporter could not wake him up so he had to go to the hospital. The patient underwent lab tests and procedures which included oxygen saturation: dropped on unknown date. Therapeutic measures were taken as a result of oxygen dropped. The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,Smoker (She reported that he still smokes.),Medical History/Concurrent Conditions: Lung cancer (they just told him he has lung cancer),,,"['Loss of consciousness', 'Malaise', 'Oxygen saturation', 'Oxygen saturation decreased']",1,PFIZER\BIONTECH, 1100524,NM,30.0,F,"fell faint(fainted); heart flutters; This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL3246, intramuscular on 29Jan2021 14:15 at a single dose for COVID-19 immunization. Medical history included MVA (motor vehicle accident), TBI (traumatic brain injury) in 2007, vagovasal and Hypotension post TBI (traumatic brain injury), Celiac Disease. The patient had known allergies: ibuprofen and milk products. Concomitant medication included famotidine, methylphenidate, fludrocortisone, omeprazole, desvenlafaxine succinate (PRISTIQ), brexpiprazole (REXULTI), folic acid, ibuprofen and progesterone. On 29Jan2021 14:15, the patient experienced heart flutters and ""fell faint"" (fainted) and assisted safely to the ground. Patient was monitored and released. No treatment given. The patient had no other vaccines in the last four weeks. The patient has not tested positive for COVID post vaccination. The outcome of the events was recovered on Jan2021. The events were assessed as serious- medically significant.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded.This case will be re-evaluated upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/29/2021,01/29/2021,0.0,OTH,FAMOTIDINE; METHYLPHENIDATE; FLUDROCORTISONE; OMEPRAZOLE; PRISTIQ; REXULTI; FOLIC ACID; IBUPROFEN; PROGESTERONE,,"Medical History/Concurrent Conditions: Automobile accident; Celiac disease; Hypotension; Milk allergy (known allergies: ibuprofen, milk products (unknown reactions for both)); Traumatic brain injury (TBI in 2007)",,,"['Cardiac flutter', 'Syncope']",1,PFIZER\BIONTECH,OT 1100525,,39.0,F,"red blotch - broken blood vessel on white of right eye; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El9266) on left arm, via an unspecified route of administration on 22Feb2021 18:00 at single dose for COVID-19 immunisation. Medical history included COVID from an unspecified date (if COVID prior vaccination: yes). The patient's concomitant medications were not reported. The patient experienced red blotch - broken blood vessel on white of right eye on 23Feb2021 07:00. The patient had no other vaccine in four weeks. The patient was not COVID tested post vaccination. There was no treatment received for the adverse event. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/23/2021,1.0,OTH,,,Medical History/Concurrent Conditions: COVID-19,,,['Eye haemorrhage'],1,PFIZER\BIONTECH, 1100529,MI,42.0,F,"unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Low energy; dizzy; mild headache/severe headache; Sore arm; tired/Fatigue; This is a spontaneous report from a non-contactable Pharmacist reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at right arm on 29Jan2021 13:45 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. The patient's medical history included allergies to Sulfa, PCN, Ceph. Concomitant medications included calcium, colecalciferol (VITAMIN D) and Multivitamin. Patient was not pregnant. On 29Jan2021 07:00 PM: Sore arm, tired at night, 30Jan2021: Sore arm, fatigue, mild headache, 31Jan2021: Fatigue, severe headache, hypotension, pale face, diarrhea, facial numbness, nausea, general weakness, dizzy, 01Feb2021: Fatigue, severe headache, unexplained bruising, facial numbness, nausea, general weakness, dizzy. Employee Health sent patient for COVID testing at 13:20 (result: Negative). 02Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 03Feb2021- 12Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 11Jan2021: Fatigue, facial numbness. 12Feb2021: Fatigue, severe headache, facial numbness, general weakness. 23Feb2021 - Present: Low energy, intermittent mild-medium headaches. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of sore arm and headache included Pain relievers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Considering temporal association and lacking of alternative explanation, a possible contributory role of BNT162B2 to all reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/29/2021,01/29/2021,0.0,PVT,CALCIUM; VITAMIN D [COLECALCIFEROL],,Medical History/Concurrent Conditions: Penicillin allergy; Sulfonamide allergy,,,"['Asthenia', 'Contusion', 'Diarrhoea', 'Dizziness', 'Fatigue', 'Headache', 'Hypoaesthesia', 'Hypotension', 'Nausea', 'Pain in extremity', 'Pallor', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1100530,NC,49.0,F,Patient has MS and UC - weeks of lethargy; Patient has MS and UC - weeks of lethargy; lethargy; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Feb2021 01:00 PM at single dose for COVID-19 immunisation. Medical history included COVID-19 prior vaccination. The patient's concomitant medications were not reported. The patient was not pregnant. Patient has MS (multiple sclerosis) and UC (ulcerative colitis) - weeks of lethargy on Feb2021. AE resulted in doctor or other healthcare professional office/clinic visit. Unknown if treatment received. The patient underwent lab tests and procedures which included SARS-CoV-2 test: COVID yes prior vaccination. Events outcome was recovering. Information about lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: COVID-19 (If covid prior vaccination: Yes),,,"['Colitis ulcerative', 'Lethargy', 'Multiple sclerosis', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1100531,,,U,"Bell's palsy; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL9269), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that the patient had an attack of bell's palsy on an unspecified date. Outcome of the event was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"[""Bell's palsy""]",1,PFIZER\BIONTECH, 1100532,NM,42.0,F,"faint with passing out after 10minutes of receiving vaccination; faint with passing out after 10minutes of receiving vaccination; dizzy/lightheadedness; HR 120/Palp; This is a spontaneous report from a contactable pharmacist. A 42-year-old female patient (pregnant unknown at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration on 22Jan2021 10:00 AM at single dose for COVID-19 immunization. Medical history included allergies to sulfa drugs. The patient's concomitant medications were not reported. The patient previously took azithromycin and experienced allergy to azithromycin. Patient with history of allergy to azithromycin and sulfa drugs. The patient experienced lightheadedness, dizzy, and faint with passing out after 10minutes of receiving vaccination on 22Jan2021 10:10 AM. Nurse lead and observer present. Patient had VSS: HR 80 120/Palp, SaO2 97% on RA CBG: 105. Assess by EMS on duty. Symptoms improving after placed on gurney and water provided. Patient reported not having had eaten before being vaccinated. Water given and patient continued to be observed for a total of 45 minutes. Patient discharged home with her ride with VSS: b/p 120/90, HR 84, Skin: PWD, SaO2 96% on RA. There was no treatment received for the adverse events. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown the list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient been tested for COVID-19. The outcome of the event was recovered on an unspecified date in 2021. Seriousness criteria: results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect were no.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events faint and passed out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/22/2021,01/22/2021,0.0,PUB,,,Medical History/Concurrent Conditions: Sulfonamide allergy,,,"['Blood glucose', 'Blood pressure measurement', 'Dizziness', 'Heart rate', 'Heart rate increased', 'Loss of consciousness', 'Oxygen saturation', 'Syncope']",UNK,PFIZER\BIONTECH, 1100534,,49.0,U,"convulsing throughout the night; Woke up with a fever of 102.4 degrees; This is a spontaneous report from a contactable consumer(parent). A 49-year-old patient of an unspecified gender received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included 2 types of prescription medication (name of medications not known). Patient previously received first dose BNT162B2 on unknown date for covid-19 immunization. The patient experienced woke up with a fever of 102.4 degrees and convulsing throughout the night on an unspecified date with outcome of unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/23/2021,,,UNK,,,,,,"['Body temperature', 'Pyrexia', 'Seizure']",2,PFIZER\BIONTECH, 1100535,TN,,F,"Pneumonia; she is too weak to move; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. This consumer reported similar events for two patients. This is the first of two reports. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia (pneumonia) on an unspecified date. It was also reported that the patient was unable to receive her second dose since she was too weak to move on an unspecified date. Outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021233483 Same reporter, drug, similar event and different patients",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Asthenia', 'Pneumonia']",1,PFIZER\BIONTECH, 1100536,TN,,U,"Pneumonia; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. The consumer reported similar events for 2 patients. This is 2nd of 2 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pneumonia after receiving first dose. Reporter stated that a friend also got pneumonia after receiving first dose. Outcome of event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021233471 Same reporter, drug, event and different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Pneumonia'],1,PFIZER\BIONTECH, 1100537,MA,,M,"received first vaccine and a few days later lost hearing in left ear; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 92-year-old male patient received the first dose of BNT162B2 (lot no. and expiry date was not reported), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. A few days later after receiving his first dose of the COVID-19 vaccine the patient experienced lost of hearing in left ear (on unspecified date in 2021), currently recieving cortisone injections and has partial recovery. Worried he will lose all hearing when he recieves second dose. The outcome of the event was recovering. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/04/2021,,,UNK,,,,,,['Deafness'],1,PFIZER\BIONTECH, 1100538,UT,,M,"terrible sore throat after the first dose; This is a spontaneous report from a Pfizer-sponsored program from a contactable Other HCP report for husband. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The Other HCP asked to cancel the scheduled appointment for her husband's 2nd dose. Her husband had been hospitalized. He has a terrible sore throat after the first dose. The event outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on data provided, the causal association between sore throat and the Pfizer -Biontech Covid 19 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,['Oropharyngeal pain'],1,PFIZER\BIONTECH, 1100541,NY,,F,"kidney failure; This is a spontaneous report from a Pfizer Sponsored Program from a contactable nurse (patient's daughter). A 101-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 10Feb2021 for COVID-19 immunisation. Medical history and concomitant medication were not reported. Reporter was asking for her mom. Her mom got her first dose of the vaccine on 10Feb. Two weeks after receiving the first dose, her mom's kidney markers elevated leading to kidney failure on an unspecified date. She said that before the vaccine her mom's kidney markers were okay. The outcome of event was unknown.; Sender's Comments: The causal association of the event renal failure and suspected drug BNT162B2 cannot be totally excluded. Case will be reassessed once new evidences and information are reported. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,,,UNK,,,,,,"['Renal failure', 'Renal function test']",1,PFIZER\BIONTECH, 1100542,KY,,F,"macular degeneration; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer report for self. This female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Feb2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had a procedure called ""macular degeneration"" before her 2nd dose vaccine schedule. She had 1st dose last 18Feb2021 and 2nd dose scheduled on 11Mar2021. The outcome of event was unknown. Information about lot/batch number has been requested. Amendment: This follow-up report is being submitted to amend previously reported information: to amend ""Product Not Administered"" to unchecked.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,,,UNK,,,,,,['Macular degeneration'],1,PFIZER\BIONTECH, 1100543,OH,,U,"cardiac arrhythmia's; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), at single dose, on an unspecified date via unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. 2 weeks post second dose of vaccine, the patient experienced cardiac arrhythmia intermittent. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Arrhythmia'],2,PFIZER\BIONTECH, 1100544,CA,,F,"allergic reaction; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a 70-year-old female patient (reporter's wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced allergic reaction. The patient was being monitored in the hospital. Corrective treatments taken as a result of the event included antihistamine. The outcome of the event was unknown. The information on the batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,['Hypersensitivity'],1,PFIZER\BIONTECH, 1100545,OH,,F,"miscarriage after receiving both doses of COVID19 vaccine; This is a spontaneous report received from Pfizer sponsored program from a contactable consumer reported for self. A female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient is pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient had a miscarriage after receiving both doses of COVID-19 vaccines. The patient received no treatment. The outcome of event was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Abortion spontaneous'],2,PFIZER\BIONTECH, 1100555,AL,,F,Covid-19 positive; Covid-19 positive; This is a spontaneous report received from a Pfizer sponsored program Pfizer from a contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Feb2021 at single dose for COVID-19 immunization. Medical history included exposure to Covid-19 (her boyfriend was covid positive). Concomitant medications were not reported. The patient got Covid-19 positive as her boyfriend was covid positive. The patient had 1st dose last 18Feb2021 and 2nd dose will be on 11Mar2021. Boyfriend didn't take any vaccine. The outcome of all events was unknown. Information on the lot/batch number has been requested.,Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/18/2021,,,UNK,,,Medical History/Concurrent Conditions: Exposure to COVID-19,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1100558,NY,52.0,F,"Felt a wave of heat come over; Felt her tongue started to swell; Her lips became numb; Her throat became scratchy; Hard to swallow; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EN 6205), via an unspecified route of administration in the left arm, on 02Mar2021 at 16:15, at single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, contrast media allergy (CAT scan die). No other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination. Concomitant medications included quetiapine fumarate (SEROQUEL), zolpidem tartrate (AMBIEN), rosuvastatin calcium (CRESTOR), metoprolol succinate (TOPROL), prazosin (unknown manufacturer), alprazolam (XANAX). The patient previously took metoclopramide hydrochloride (REGLAN) and experienced drug hypersensitivity, prochlorperazine maleate (COMPAZINE) and experienced drug hypersensitivity, promethazine (PHENERGAN) and experienced drug hypersensitivity. On 02Mar2021 at 16:15, about 30 seconds after vaccination was administered, the patient felt a wave of heat come over, felt her tongue started to swell, her lips became numb, her throat became scratchy, hard to swallow. The events caused patient's hospitalization in Mar2021, required physician office visit and emergency room visit. Therapeutic measures were taken as a result of the events and included treatment with EpiPen, Benadryl, steroids and 2 others medications. The events recovered in Mar2021. Patient was not tested for COVID-19 post vaccination. The events were considered life-threatening. Follow-up attempts are completed. No further information is expected.",Not Reported,,Yes,Yes,,Not Reported,Y,03/02/2021,03/02/2021,0.0,UNK,SEROQUEL; AMBIEN; CRESTOR; TOPROL; PRAZOSIN; XANAX,,Medical History/Concurrent Conditions: Contrast media allergy (CAT scan die); Type II diabetes mellitus,,,"['Dysphagia', 'Feeling hot', 'Hypoaesthesia oral', 'Swollen tongue', 'Throat tightness']",1,PFIZER\BIONTECH, 1100562,NM,83.0,F,"She died 5 days after her second vaccine; This is a spontaneous report from a contactable consumer. An 83-year-old female patient (Not pregnant) received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number not provided), via an unspecified route of administration in the left arm on 12FEB2021 at 03:00 PM (at the age of 83-years-old) at single dose for covid-19 immunisation. The subject had a history of Heart condition and thyroid. Relevant concomitant medications included calcium, fish oil, multivitamin and potassium. The patient died on 16Feb2021 (12:00 PM), 5 days after her second dose of vaccine (as reported). The cause of patient's death was unknown. She had no adverse effects until her death. It was unknown if autopsy was performed. Information on batch/lot number was requested.; Reported Cause(s) of Death: She died 5 days after her second vaccine",Yes,02/16/2021,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/16/2021,4.0,UNK,CALCIUM; FISH OIL; POTASSIUM,,Medical History/Concurrent Conditions: Heart disorder; Thyroid disorder,,,['Death'],2,PFIZER\BIONTECH, 1100565,AZ,29.0,F,"some kind of back pain, behind her heart; heart pain; pretty strong chest pain; fatigue caused by the vaccine was so profound; This is a spontaneous report received from a contactable consumer(reporting for her daughter) A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 expiry date 31Mar2021 via an unspecified route of administration on 08Jan2021 (at the age of 29-year-old) at single dose for COVID-19 immunisation. The first dose of bnt162b2 was taken on 17Dec2020. The patient's medical history included bipolar disorder. Concomitant medications included quetiapine (QUETIAPINE). The patient experienced some kind of back pain, behind her heart, heart pain and pretty strong chest pain on 08Jan2021 with outcome of recovered. In addition experienced ""fatigue caused by the vaccine was so profound that was advised to not take her bipolar medication, quetiapine"" on an unspecified date with outcome of recovered. It was reported that ""It took 36 hours for the extreme fatigue to stop. This was very frightening because being without the medication could cause auditory hallucinations to return after 36 hours. There should be a warning for people who must take sedative medication regularly so that they can make an informed decision about whether or not to receive the vaccine"".",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/08/2021,01/08/2021,0.0,UNK,QUETIAPINE,,Medical History/Concurrent Conditions: Bipolar disorder,,,"['Angina pectoris', 'Back pain', 'Chest pain', 'Fatigue']",2,PFIZER\BIONTECH, 1100650,CA,65.0,F,Patient died two days after receiving vaccine. Death certificate said respiratory failure.,Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/12/2021,2.0,PVT,High blood pressure medicine Gabba pentin.,Copd,Back pain,,None,"['Death', 'Respiratory failure']",UNK,MODERNA, 1100685,,72.0,M,Death 1 week later. No other information available.,Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/12/2021,7.0,PVT,,,"CAD, nasopharyngeal carcinoma",,,['Death'],1,PFIZER\BIONTECH,IM 1100701,NY,34.0,M,"Severe anxiety, nervousness, panic feeling, pacing, shaking, aches, chills, irritability, headache. Unable to function mentally due to severe irritability. Experiencing similar symptoms to when actually tested positive for COVID 19 in March of 2020.",Not Reported,,Not Reported,Not Reported,,Yes,N,03/14/2021,03/15/2021,1.0,PVT,,,,,,"['Anxiety', 'Chills', 'Disturbance in attention', 'Headache', 'Irritability', 'Nervousness', 'Pain', 'Panic reaction', 'Restlessness', 'Similar reaction on previous exposure to drug', 'Tremor']",1,JANSSEN,IM 1100824,,48.0,F,"out of rhythm; heart rate increased; shortness of breath; impaired vision; some dizziness; Reported sleeping more heavily than usual; woke with her hair wet as if had experienced a fever overnight; anxious; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient started received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# not provided), via an unspecified route of administration on 03Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient has known allergies to sulfur and penicillin. Concomitant medications were not reported. The patient received first dose of vaccine on 03Feb2021. Immediately following injection, felt as if her heart rate increased; felt as if it remained out of rhythm through Thursday evening eventually returning to a more regular rhythm. She also experienced shortness of breath, impaired vision and some dizziness noted in Feb2021. She also been sleeping more heavily than usual woke with her hair wet as if had experienced a fever overnight. She stated she felt better, but still not at what she would consider her normal self and was anxious about receiving the second dose and wanted to speak with someone to further discuss her concerns. Outcome of anxious was unknown while recovering for the remaining events Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Penicillin allergy,,,"['Anxiety', 'Arrhythmia', 'Dizziness', 'Dyspnoea', 'Feeling abnormal', 'Heart rate', 'Heart rate increased', 'Somnolence', 'Visual impairment']",1,PFIZER\BIONTECH, 1100865,MI,77.0,M,Patient died within 24 hours of vaccine. Unknown at this time if related.,Yes,03/14/2021,Not Reported,Not Reported,,Not Reported,N,03/13/2021,03/14/2021,1.0,PVT,"Cefuroxime, Lansoprazole, Sulfasalazine, Azulfidine, Amoxicillin, Lisinopril, Fluticasone Nasal Spray, Tenormin, Atenolol,",Hospitalized for Pneumonia 2-8-2021,"Hypertension, obesity",,Unknown,['Death'],1,JANSSEN,IM 1100904,,,F,"non-hodgkins lymphoma,; a little fever this morning; pretty severe joint pain, from her jaw to her ankles; This is a spontaneous report from a non-contactable nurse (patient) via Medical Information Team. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine and had been fine. On 05Feb2021, mid afternoon, she went to an urgent care and tested negative for COVID and the flu. On 06Feb2021, she was fine, had a little fever in the morning, but about 3 in the afternoon, she started with pretty severe joint pain from her jaw to her ankles. She was recently diagnosed with non-Hodgkins Lymphoma and they put her on a chemo and a monoclonal antibody. One of the oncologists thinks it was a reaction to the vaccine. Outcome of the events was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: Based on the limited information currently available, a causal relationship between event non-Hodgkins Lymphoma and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,,,UNK,,,,,,"['Arthralgia', ""Non-Hodgkin's lymphoma"", 'Pyrexia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1100905,NJ,,M,"COVID like symptoms; COVID like symptoms; I had a cough and all that stuff; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 18Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first COVID19 vaccine dose on 18Jan2021. He got COVID like symptoms and he had a cough and all that stuff starting about 3 days ago in Feb2021. A COVID test was done 03Feb2021 with unknown results. He was admitted to the hospital on 03Feb2021, he does not have the results of the test. He is scheduled on 05Feb2021 for his second dose of the vaccine. He was wondering if he should still get his second dose that is scheduled tomorrow, 05Feb2021. But his doctor suggested not to get the second dose. The outcome of the events was unknown.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/18/2021,02/01/2021,14.0,UNK,,,,,,"['Cough', 'Drug ineffective', 'SARS-CoV-2 test', 'Suspected COVID-19']",1,PFIZER\BIONTECH, 1100951,KY,82.0,M,Patient was found unresponsive by family members in the early morning on 2/23/2021. Patient passed away.,Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/23/2021,20.0,PVT,Tylenol 325mg 2 tabs q4hrs prn; diltiazem 180mg 1 QD; glimepiride 1mg 1 BID; Humalog 3 units before meals subq; Lantus 36 units QAM; lisinopril 40mg 1 QD; metformin 1000mg 1 BID; pravastatin 40mg 1 QD; Januvia 50mg 1 QD.,Unknown; COVID test was negative upon death.,"Multiple co-morbidities, including persistent atrial fibrillation, chronic diastolic heart failure, hypertension with chronic kidney disease, Type 2 diabetes, hyperlipidemia, and history of a CVA in March 2020 and a subdural hematoma from a fall (for which he was admitted from 3/17-18/20)",,NKA,"['Death', 'SARS-CoV-2 test negative', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,IM 1101143,NY,29.0,M,"Asthma Reaction; Dizzy; Lighted headed; Difficulty breathing; A spontaneous report was received from a consumer who is a 29-year-old male patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness, light headed, asthma reaction (asthmatic crisis) and difficulty breathing. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included pantoprazole 40 mg. On 28-Dec-2020, approximately three hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 28-Dec-2020, the patient developed dizziness, became light headed, experienced an asthmatic reaction and difficulty breathing. The events were treated with a dose of albuterol. The patient was transported to the Emergency Room but additional information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, dizziness, light headed, asthma reaction and difficulty breathing was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,12/28/2020,12/28/2020,0.0,UNK,PANTOPRAZOLE,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Asthmatic crisis', 'Dizziness', 'Dyspnoea']",1,MODERNA,OT 1101145,MD,59.0,M,"Facial paralysis; Bradycardia; Weakness on his right arm and right leg; Some difficulty talking; right leg is numb; Sees blurry; Severe headache; A spontaneous report was received from a paramedic who was a 59-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced sees blurry, bradycardia, facial paralysis, weakness on his right arm and right leg, right leg is numb, some difficulty talking and severe headache. The patient's medical history was not provided. Relevant concomitant medications included insulin, metformin, statins and losartan. On 07-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) in the left arm intramuscularly for prophylaxis of COVID-19 infection. On 07-Jan-2021, post vaccination, the patient reported he experienced some eye issues and that his vision was blurry and that he had a severe headache. On 23-Jan-2021, the patient stated he was admitted into the hospital for 36 hours. He had facial paralysis, bradycardia, weakness in his right arm and leg, difficulty talking, and his right leg was numb. Per the patient, they thought he was having a stroke but the results of all the tests showed he did not have a stroke. The hospital discharged him and instructed him to follow up with a neurologist. Treatment included, prednisone, valtrex and unspecified medication to calm down. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, sees blurry, bradycardia, facial paralysis, weakness on his right arm and right leg, right leg is numb, some difficulty talking and severe headache, were considered not recovered/not resolved.; Reporter's Comments: This case concerns a 59-year-old, male patient. who experienced serious events of vision blurred bradycardia, facial paralysis, hemiparesis, hypoesthesia, speech disorder and severe headache. The patient was admitted into the hospital for 36 hours and all the tests showed he did not have a stroke. He was instructed to follow up with a neurologist. Further information has been requested.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,01/07/2021,01/07/2021,0.0,UNK,INSULIN; METFORMIN; STATIN [ATORVASTATIN CALCIUM]; LOSARTAN,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Bradycardia', 'Facial paralysis', 'Headache', 'Hemiparesis', 'Hypoaesthesia', 'Speech disorder', 'Vision blurred']",1,MODERNA,OT 1101148,,,U,"Cellulitis; A spontaneous report was received from a Non Health Professional concerning a unspecified old, unspecified gender patient was participating in the mRNA-1273 Emergency Use Program and developed cellulitis. The patient's medical history was not provided by the reporter. Concomitant medications were not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 on unspecified date ( LOT/BATCH: unknown) , intramuscularly in an unknown arm for prophylaxis of COVID-19 infection. On unspecified date, the patient experienced cellulitis. Treatment history included antibiotic. Action taken for mRNA-1273 in response to the event was unknown. The outcome of the event, cellulitis was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Cellulitis'],1,MODERNA,OT 1101150,LA,78.0,F,"Cellulitis; Red circle and it covered the fleshy part of her arm; A spontaneous report was received from a consumer concerning a 78-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed red circle and it covered the fleshy part of her arm/vaccination site erythema and cellulitis. The patient's medical history was not reported. Concomitant product use was not reported. On 17 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in right arm for prophylaxis of COVID-19 infection. On 31 Jan 2021, approximately four days after receiving the vaccine, the patient developed a red circle and it covered the fleshy part of her arm. She was put on antibiotics for cellulitis and after a couple of days it went away, but she finished the seven days of antibiotics. On 14 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in right arm for prophylaxis of COVID-19 infection. Action taken with mRNA-1273 in response to the events was continued. The outcome of the events, vaccination site erythema and cellulitis were considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/17/2021,01/31/2021,14.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Cellulitis', 'Vaccination site erythema']",2,MODERNA,OT 1101151,IA,92.0,F,"Sore arm; Passed out; loss sense of time for 36 hr; so weak to get up; Vomiting for several time; A spontaneous report was received from a consumer, who was a 92 year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, lose the sense of time, vomiting for several time, so weak to get up and passed out. The patient's medical history included cancer, restless leg syndrome, allergies to shellfish and currently living in hospice. Concomitant products included rivaroxaban, digoxin, diltiazem, omeprazole, pramipexole, vitamin D3, budesonide and paracetamol prn. On 19 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 004M20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date after receiving the vaccine, the patient experienced sore arm. One night, she lost the sense of time for 36 hours. She got up in the middle of night and went to bathroom and was vomiting for several time. She then got back to bed with waste basket and was so weak to get up. She called the nursing home next door and she believed that they may have called 911 but was not full sure if they did or did not. The next day morning, one of the neighbors came to check on her at 11 am. When the neighbor tried to wake her up, she was passed out therefore the nursing home called 911 again. Patient believed that nurse gave her a shot to stop vomiting but do not clearly remember. She was not planning on getting the second dose of the vaccine. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, sore arm and so weak to get up, were unknown. The outcome of the events, lose the sense of time and passed out, were considered resolved on 22 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/19/2021,02/21/2021,2.0,UNK,XARELTO; DIGOXIN; DILTIAZEM; OMEPRAZOLE; PRAMIPEXOLE; VITAMIN D3; BUDESONIDE; TYLENOL,Hospice care,Medical History/Concurrent Conditions: Cancer; Restless leg syndrome; Shellfish allergy,,,"['Asthenia', 'Loss of consciousness', 'Pain in extremity', 'Time perception altered', 'Vomiting']",1,MODERNA,OT 1101152,TN,72.0,F,"Blood clot on right lung; soreness in arm; A spontaneous report was received from a 72 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced blood clot on right lung (pulmonary embolism) and myalgia. The patient's medical history was not provided. The patient had family history of blood clot (mother and brother). No concomitant product use was reported. On 02-Feb-2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 011M20A) intramuscularly for prophylaxis of COVID-19 infection. The patient had soreness in the right arm which subsided couple of days later. The patient also experienced shortness of breath for a week after vaccine administration. On 17-Feb-2021, the patient went to the hospital and underwent COVID-19 virus test, the results of which were negative. On 17-Feb-2021, the computerized tomography scan on chest showed moderate size blood clot on right lung. On 18-Feb-2021, the patient was discharged from the hospital on recommendation to initiate and continue lifetime treatment with Eliquis (apixaban, 5mg every 12 hours). According to the physician, moderate size blood clot on right lung of the patient could be attributed to the genetic history (patient's mother and brother also had blood clot). The patient also followed up with primary care physician, who informed that it was genetic and not related to vaccine. Action taken with mRNA-1273 was not reported. The outcome of the events, pulmonary embolism was unknown. The outcome of the event, myalgia was considered as recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,02/02/2021,02/17/2021,15.0,UNK,,Pulmonary embolism (The patient's mother and brother had blood clot),Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,"['Computerised tomogram', 'Myalgia', 'Pulmonary embolism', 'SARS-CoV-2 test']",1,MODERNA,OT 1101153,CT,46.0,F,"Asphyxiation; like had a heart attack; Blood pressure was 150/90; sever allergic reaction; lethargic; Arrhythmia; Fast heartbeat; A spontaneous report was received from a 46 year old female who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced asphyxiation, fast heartbeat, lethargy, blood pressure 150/90, arrhythmia and a heart attack like episode. The consumer received the first of the two planned doses of mRNA-1273 on 05-FEB-2021 (Batch #: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. On 06-FEB-2021, Patient experienced fast heartbeat. On 07-FEB-2021, she became lethargic. On 08-FEB-2021, she called the EMT due to complaints of rapid heartbeat as if she was experiencing arrhythmia. The patient stated that her blood pressure was 150/90, as well as, she had asphyxiation and felt like she had a heart attack. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The patient's medical history was not provided. No relevant concomitant medications were reported. The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Arrhythmia', 'Asphyxia', 'Blood pressure abnormal', 'Heart rate increased', 'Hypersensitivity', 'Lethargy', 'Myocardial infarction']",1,MODERNA,OT 1101154,FL,87.0,M,"Husband experienced seizure lasting 30min. after taking 2nd vaccine. 1st vaccine on 26/01/21 LOT# 00TM20A. 2nd on 23/02/21 LOT# 024M20A,5 Days after; the Ambulance took husband to hospital & Dr put the patient on a seizure med Levetiracitam 500mg; A spontaneous report was received from a consumer, concerning 87-year-old male patient, who received his second dose of Moderna's COVID-19 vaccine and experienced seizure that lasted about a half an hour. Medical history included: seizure 37 years ago during a stroke. There were no concomitant medications reported. On 26-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot Number: LOT# 00TM20A) and on 23-Feb-2021, he received the second dose of mRNA-1273 (LOT# 024M20A), intramuscularly for prophylaxis of COVID-19 infection. On 28-Feb-2021, five days post receive the vaccine, the patient experienced a seizure which lasted about a half an hour. The patient was taken to hospital and was treated with Levetiracitam 500mg. Action taken with the dose of mRNA-1273 in response to the event was not reported. The outcome for the event was considered as resolved on 28-Feb-2021.; Reporter's Comments: Based on the current available information which show a temporal association between the use of the product and excluding all other etiologies as reported (subject experienced seizure 37 years ago), a causal relationship with the event cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/26/2021,02/28/2021,33.0,UNK,,,Medical History/Concurrent Conditions: Seizure; Stroke,,,['Seizure'],2,MODERNA,OT 1101155,CA,27.0,F,"mild anaphylactic shock; Tachycardia; deep Flush; Missed dose; A spontaneous report was received from a nurse concerning a female patient of 27 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced tachycardia,deep flush and anaphylactic reaction. The patients medical history was not provided.No relevant Concomitant medications were reported. On 09 jan 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 037K20A ) vaccine for prophylaxis of COVID-19 infection. On an unknown date,patient experienced mild anaphylactic shock to vaccine and developed tachycardia and deep flush. No Treatment information for the event was provided. At the time of the report it as 42 days since the first dose, and patient has not received the second dose. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event tachycardia,deep flush and anaphylactic reaction was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/09/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Anaphylactic shock', 'Flushing', 'Product dose omission issue', 'Tachycardia']",1,MODERNA,OT 1101156,FL,73.0,F,"Hospitalised with heart condition; This spontaneous report was received from a nurse concerning, a 73-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was hospitalized with a heart condition/heart disorder. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 07 Feb 2021, prior to the onset of events, the patient received their first of the two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient was hospitalized for a heart condition. No treatment information was provided. Action taken with suspect drug mRNA-1273 was unknown. The outcome of the event, hospitalized with a heart condition, was unknown.; Reporter's Comments: The events were consistent with increased risk of cardiovascular complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/07/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Cardiac disorder'],1,MODERNA,OT 1101157,OH,78.0,F,"blood clot in left forearm; Sore arm; A spontaneous report was received from a consumer concerning a78, year, old, female patient who developed a blood clot in the left forearm. The patient's medical history included hypertension, hiigh cholesterol and hypothyroidism. On 19-JAN-2021 the patient had two stents placed in her heart. Products known to have been used by the patient, within two weeks prior to the event, included clopidogrel bisulfate (One 5 milligram AM and PM) and apxaban (One 5 milligram AM and PM) and Asprin. On 10-FEB-2021, approximately six days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient had a sore arm for about a day after the vaccination. Six days later the left arm was red and swollen, inside forearm four inches down below the elbow it was stinging, slightly swollen, just to a soft touch she felt lumps of swelling. The patient went to the emergency room and had blood work and an ultrasound. The emergency room doctor told her that she had a blood clot in the left forearm four inches down below the elbow. The lab test done at the emergency were blood work and ultrasound. Treatment for the event included changing her current medication to one clopidogrel bisulfate 5 milligrams AM and PM and apxaban two tablets of 5 milligrams AM and PM and to discontinue the Asprin for one week. There was no change planned to the dosing schedule of mRNA-1273 in response to the event(s) and is scheduled to get her second vaccination 10-MAR-2021. The outcome of the events were considered as unknown. Follow up: No follow up information received.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,02/10/2021,0.0,UNK,ELIQUIS; PLAVIX,,Medical History/Concurrent Conditions: High cholesterol; Hypertension; Hypothyroidism; Stent placement,,,"['Pain in extremity', 'Thrombosis']",1,MODERNA,OT 1101158,CA,49.0,F,"almost fainted; low blood pressure; sore arm; shaking (chills); A spontaneous report was received from a forty-nine-years old female consumer, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced low blood pressure, almost fainted, sore arm and shaking (chills). The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received the first of the two planned doses of mRNA-1273 on 25-Jan-2021 (Batch# 041L20A) intramuscularly for prophylaxis of COVID-19 infection. Approximately 12 hours later , she experienced low blood pressure, almost fainted, had sore arm and had shaking (chills). No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported The outcome of the events was reported; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events 12 hours after vaccination, a causal relationship cannot be excluded. Further information has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history),,,"['Chills', 'Hypotension', 'Syncope', 'Vaccination site pain']",1,MODERNA,OT 1101159,AZ,74.0,F,"Terrible headache; High blood pressure; Stiff neck; A spontaneous report was received from a consumer in the concerning a 74-year-old female patient who experienced headache/MedDRA PT: headache, high blood pressure/MedDRA PT: hypertension and stiff neck/MedDRA PT: musculoskeletal stiffness. No medical history was reported. Concomitant medications include montelukast and hydrochlorothiazide. On 18-Feb-2021, this patient received their first planned dose of mRNA-1273 solution for injection, dosage not provided, (Lot/Batch number: 011L20A) in her right arm for prophylaxis of COVID-19 infection. On 18-Feb-2021, following the administration of the vaccine, the patient experienced a terrible headache, high blood pressure and a stiff neck. On 25-Feb-2021, she was transported to the Emergency Department by her friend because she was unable to drive. She was hospitalized and administered IV fluid, Ativan (lorazepam) and a ""cocktail"". She was discharged from the hospital on 26-Feb-2021. She has not recovered from the headaches. Her physician advised her not to get the second dose of the vaccine. Action taken with mRNA-1273 in response to the event was unknown. The outcome for the event headache/MedDRA PT: headache is not recovered. The outcome for the events high blood pressure/MedDRA PT: high blood pressure and stiff neck/MedDRA PT: musculoskeletal stiffness is recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/18/2021,02/18/2021,0.0,UNK,MONTELUKAST; HYDROCHLOROTHIAZIDE,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Headache', 'Hypertension', 'Musculoskeletal stiffness']",1,MODERNA,OT 1101160,MD,75.0,F,"Horrific nosebleed; Blood pressure reading was 70/46 mmHg; Fatigue for a couple days, she was tired; Pain in the arm; A spontaneous report was received from a consumer concerning 75-years-old, female patient who experienced horrific nosebleed (epistaxis), fatigue for a couple days, she was tired (fatigue), pain in the arm (pain in extremity), and blood pressure reading was 70/46 mmHg (hypotension). The patient's medical history included nosebleeds, high blood pressure, and diabetes type-2. Products known to have been used by the patient, within two weeks prior to the event, included lisinopril, metformin, atorvastatin calcium, iron, and ascorbic acid. The patient received their first of two planned doses of mRNA-1273 (lot: not provided) intramuscularly for prophylaxis of COVID-19 infection on 20 Feb 2021, at 1:40 PM. On 21 Feb 2021, approximately at 9:00 morning, the patient was awakened by the feeling of something in her throat which she described as a horrific nosebleed. She stated that she was unable to stop the bleeding and went to an urgent care facility and was then transported to the hospital. On the same day, the patient reported that she was admitted, and her blood pressure reading was 70/46 mmHg. On 23 Feb 2021, she was released after two days of stay. The patient reported that the hospital did not provide an explanation for the cause of the nosebleed. The patient reported felt pain in her arm and felt fatigued for a couple of days after receiving her first dose of the vaccine. She stated that she felt that because she was tired and because she lost a large amount of blood due to her nosebleed, that was why she required hospitalization. The patient did not take blood thinners. The patient was feeling better now. On 20 Mar 2021, the patient was scheduled to have her second dose of the Moderna vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The events, horrific nosebleed (epistaxis), fatigue for a couple days, she was tired (fatigue), pain in the arm (pain in extremity), and blood pressure reading was 70/46 mmHg (hypotension), were considered resolving.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/20/2021,02/20/2021,0.0,UNK,LISINOPRIL; METFORMIN; STATIN [ATORVASTATIN CALCIUM]; IRON; VITAMIN C [ASCORBIC ACID],"Blood pressure high (The patient had a 20-year history of high blood pressure and Diabetes Type-2); Nose bleeds (During the past eight years, patient had five nosebleeds which resulted in hospitalization. She has been told in the past that it was due to the thin lining inside her nose.); Type 2 diabetes mellitus (The patient had a 20-year history of high blood pressure and Diabetes Type-2)",,,,"['Blood pressure measurement', 'Epistaxis', 'Fatigue', 'Glycosylated haemoglobin', 'Hypotension', 'Pain in extremity']",1,MODERNA,OT 1101161,TX,78.0,F,"couldn't move her body at all; lay there unable to move or crawl or even pull herself up for 6-7 hours before she was discovered; no recollection of this episode of what happened to her or what she was doing at the time it occurred; she fell to her garage floor; speech was gargled; brain fog and difficulty; residual confusion; local reaction limited arm movement; local reactions such as pain; A spontaneous report was received from a consumer concerning a 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced local reactions such as pain and limited arm movement (vaccination site movement impairment/vaccination site pain), fell to garage floor (fall), couldn't move body at all (paralysis), lay there unable to move or crawl or even pull self up for 6-7 hours before discovered and taken to hospital (paralysis), brain fog and difficulty (feeling abnormal), no recollection of this episode of what happened or what she was doing at the time it occurred (amnesia), speech was gargled (dysarthria), and brain fog is improved now but still has some residual confusion (delirium). The patient's medical history was not provided. Relevant concomitant medications were not reported. On 27 FEB 2021, prior to the onset of events, the patient received their second dose of mRNA-1273 (lot/batch: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 27 FEB 2021, the patient experienced vaccination site movement impairment and vaccination site pain. On 28 FEB 2021, the patient experienced paralysis, amnesia, fall, dysarthria, and feeling abnormal and due to these events hospitalization was required. On 04 MAR 2021, the patient experienced Delirium. Laboratory details was provided as CT Scan on 28 FEB 2021 and the result was normal. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. At the time of this report, the outcome of the event's, local reactions such as pain and limited arm movement,fell to garage floor, couldn't move body at all , lay there unable to move or crawl or even pull self up for 6-7 hours before discovered and taken to hospital, brain fog and difficulty, no recollection of this episode of what happened or what she was doing at the time it occurred, speech was gargled, and brain fog is improved now but still has some residual confusion, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Yes,N,02/27/2021,02/27/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Amnesia', 'Computerised tomogram', 'Delirium', 'Dysarthria', 'Fall', 'Feeling abnormal', 'Paralysis', 'Vaccination site movement impairment', 'Vaccination site pain']",2,MODERNA,OT 1101162,FL,42.0,F,"angioedema; A spontaneous report was received from other healthcare professional concerning forty-two-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angioedema. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received the first of the two planned doses of mRNA-1273 on 30-DEC-2020 (Batch# 026L20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, approximately one week after receiving the mRNA-1273 vaccine, the patient received Botox and filler injections. Approximately 12 hours later, the patient experienced angioedema. Treatment details included prednisone 40 mg, diphenhydramine 50 mg and famotidine. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was resolved. The assessment was not provided for the event.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,12/30/2020,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Angioedema'],1,MODERNA,OT 1101163,NJ,58.0,F,"First chills; Vomiting; body aches; Head still doesn't feel normal; severe dizziness; head pressure; This is a spontaneous report from a contactable consumer. A 58 -year-old female (not pregnant) patient received her first dose on an unspecified date, second dose (lot number: EN2601) on 12Feb2021 of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), both via an unspecified route of administration (at the age of 58 -years-old), single dose for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication included clonazepam. The patient experienced First chills, vomiting, body aches, head pressure, severe dizziness and vomiting. Head still doesn't feel normal (The events were reported also to happen then 12 days later), all events started 23Feb2021 0600. The outcome of the events was recovering. The events were reported to cause 3 days hospitalization. No other vaccine in four weeks. AE Treatment: Meclizine, Zofran, EKG, MRI, CT of head. The patient had a covid swab test on 23Feb2021 with negative result.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,,02/23/2021,,OTH,CLONAZEPAM,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Chills', 'Computerised tomogram', 'Dizziness', 'Electrocardiogram', 'Feeling abnormal', 'Head discomfort', 'Magnetic resonance imaging', 'Pain', 'SARS-CoV-2 test', 'Vomiting']",1,PFIZER\BIONTECH, 1101164,NY,40.0,F,"a female patient at the hospital with appendicitis; This is a spontaneous report from a contactable physician. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , batch/lot and expiry unknown), via an unspecified route of administration on 22Feb2021 at a single dose for covid prevention. The patient's medical history was not reported. There were no concomitant medications. The patient received her first dose of Covid vaccine on 03Feb2021 (40 years) for Covid-19 immunisation. 4 days after getting her second dose of the Pfizer COVID Vaccine, patient was in the hospital with appendicitis on 26Feb2021. Patient was hospitalized, and he believes the patient was heading into the operating room (OR) now. It was confirmed that the patient had no other vaccines on the same day as both her COVID vaccine doses. The causality was reported as ""unrelated"". Information on the Lot/batch number has been requested.; Sender's Comments: In agreement with the reporting physician, the company considers that the event appendicitis is unrelated to suspect vaccine BNT162B2. Appendicitis is most likely an intercurrent condition. There is no plausible mechanism implicating BNT162B2 to the reported event based on the drug known safety profile.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/22/2021,02/26/2021,4.0,UNK,,,,,,['Appendicitis'],2,PFIZER\BIONTECH, 1101165,MO,,F,"can hardly walk; can't hardly stand up; got really sick last night; This is a spontaneous report from a contactable consumer, reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 25Feb2021 14:00 at a single dose for COVID-19 immunization. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had the first dose of BNT162B2 vaccine yesterday, 25Feb2021 14:00. She got really sick last night. Today, 26Feb2021, she can't hardly stand up. She can hardly walk. She has multiple sclerosis (MS) and is now basically bedridden. The doctor said it would take two days to get over and the she wanted to know how she can feel better. The outcome of the events was unknown. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/25/2021,02/25/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Multiple sclerosis,,,"['Dysstasia', 'Gait disturbance', 'Illness']",UNK,PFIZER\BIONTECH, 1101166,FL,78.0,M,"Collapsed in house; Chills; Total Weakness; Memory problems; Racing heart beat; This is a spontaneous report from a contactable consumer. A 78-year-old male consumer reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), into the left arm on 23Feb2021 at 01:00 PM at single dose for COVID-19 immunization. The patient had Covid prior vaccination. No other medical history. Concomitant drugs were unknown. On 23Feb2021 at 04:00 PM the patient experienced chills, total weakness, memory problems, collapsed in house and racing heart beat. The patient was hospitalized, he was in hospital 4th day now. Cannot get out of bed or walk. the patient was treated with Physical Therapy. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223394 similar report from same reporter",Not Reported,,Not Reported,Yes,4.0,Not Reported,N,02/23/2021,02/23/2021,0.0,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Asthenia', 'Chills', 'Heart rate increased', 'Loss of consciousness', 'Memory impairment']",1,PFIZER\BIONTECH, 1101239,TN,87.0,F,"Patient had been slowly declining over the past year due to dementia and age. On the date of her second vaccination, Feb. 17, she was getting around with her walker. On Friday, Feb. 19, she was so weak she was no longer able to walk with her walker, and she declined every day thereafter. On Monday, Feb. 22 she began crying and saying ""help me"". That lasted approximately a week. her health declined every day until Saturday, March 6, when she passed away at 6:15a.",Yes,03/06/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,02/19/2021,2.0,SEN,"Metropolol, Donepezil, antibiotic",UTI,"Dementia, type II diabetes, high cholesterol, high blood pressure, heart disease, kidney disease",,Sulfa drugs,"['Asthenia', 'Crying', 'Death', 'Gait disturbance', 'General physical health deterioration', 'Walking aid user']",UNK,MODERNA, 1101286,CA,80.0,F,Large Stroke,Yes,03/14/2021,Not Reported,Yes,5.0,Not Reported,N,03/03/2021,03/10/2021,7.0,PVT,"Aspirin 81mg, Metformin 100mg, Gllipizide 10mg, Simvastatin 40mg, Lisinopril 10mg.",None,Diabetes and High Blood Pressure,,None,['Cerebrovascular accident'],2,MODERNA,IM 1101322,OH,66.0,M,Client found dead by a family member.,Yes,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,03/03/2021,9.0,OTH,unknown,unknown,"COPD, High Blood Pressure",,unknown,"['Autopsy', 'Cardiomegaly', 'Death']",1,PFIZER\BIONTECH,IM 1101602,FL,74.0,M,"Later that day after receiving the shot, patient reportedly became very ill with fever, vomiting, and diarrhea. He was found deceased the next day when friends went to check on him.",Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,02/27/2021,02/27/2021,0.0,PHM,Unknown,Unknown. Postmortem COVID-19 test was negative.,"Diabetes mellitus, heart disease, hypertension",,Unknown,"['Death', 'Diarrhoea', 'Malaise', 'Pyrexia', 'SARS-CoV-2 test negative', 'Vomiting']",1,MODERNA,UN 1101643,RI,68.0,F,"severe and disabling dizziness; This is a spontaneous report from a contactable consumer. A 68-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6202) on 23Feb2021 at 16:00 at single dose via an unspecified route of administration on arm left for COVID-19 immunization. Relevant medical history included high blood pressure and myopia at -8.5. Concomitant medications included. On 24Feb2021 at 03:00 a.m. within 10 hours from vaccination, patient experienced severe and disabling dizziness. It was informed that events resulted in doctor visit. The events were longer persisting 5 days after vaccine with only minimal improvement. At the time of the reporting the patient had yet recovered from the events.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/23/2021,02/24/2021,1.0,UNK,,,Medical History/Concurrent Conditions: Blood pressure high; Nearsighted (Nearsighted -8.5),,,['Dizziness'],1,PFIZER\BIONTECH, 1101662,MI,68.0,M,PATIENT PASSED AWAY BEFORE THEY COULD RECEIVE THE SECOND DOSE OF THE SHOT. WE ARE NOT SURE IF IT WAS VACCINE RELATED OR NOT.,Yes,01/01/2021,Not Reported,Not Reported,,Not Reported,,01/21/2021,01/01/2021,,PHM,,,,,,"['Death', 'Incomplete course of vaccination']",1,PFIZER\BIONTECH,IM 1101690,MI,76.0,M,THE PATIENT HAD PASSED AWAY AND WAS UNABLE TO GET HIS SECOND SHOT TO COMPLETE THE SERIES. WE ARE UNSURE IF THE VACCINE WAS RELATED TO HIM PASSING.,Yes,02/01/2021,Not Reported,Not Reported,,Not Reported,,01/21/2021,01/01/2021,,PHM,,,,,,"['Death', 'Incomplete course of vaccination']",1,PFIZER\BIONTECH,IM 1101718,FL,92.0,F,"Patient was taken by ambulance to E.R. 3 days after injection with bleeding from the nose and blood in stool. Spent 10 days in hospital. Returned to ER a few days later with fluid leaking from arms and legs. Diagnosed with congestive heart failure. Sent home under Hospice. Returned to ER, by ambulance, 36 hrs. later. Still weeping from skin and placed in ICU. on Bipap machine . Transferred that evening to medical Care Center where she passed away on March 3, 2021.",Yes,03/03/2021,Not Reported,Yes,20.0,Not Reported,N,02/04/2021,02/07/2021,3.0,PVT,,,,,,"['Bilevel positive airway pressure', 'Cardiac failure congestive', 'Death', 'Epistaxis', 'Haematochezia', 'Intensive care', 'Skin weeping']",1,PFIZER\BIONTECH, 1101761,FL,81.0,F,"Trouble breathing. Taken to ER. Diagnosis Congestive Heart Failure. No Previous such diagnosis. Admitted for 6 days with Metropolo benign only new prescription. After 2nd shot on February 2 had follow up visits but started experiencing light headless. On February suddenly went limp with loss of pulse and breathing. Taken to Hospital ER, admitted without neurological responses. Died on February 22.",Yes,02/22/2021,Not Reported,Yes,6.0,Not Reported,N,01/12/2021,01/15/2021,3.0,PVT,Metoprol OLSUC ER 25 mg Heart Beta Block Levoxyl (Synthroid) 175 mcg Thyroid Gabapentin 1 tablet �300 mg Neuropathy Basaglar Kwikpen 25 uinits Diabetic Therapy Fosinopril Sodium 20 mg tablet Cholestral Triamt/HTCZ 37.5 mg Blood Pressure O,Diabetes,Diabetes. Hip replacements and back surgery,,None,"['Cardiac failure congestive', 'Chest X-ray', 'Computerised tomogram head', 'Death', 'Dizziness', 'Dyspnoea', 'Echocardiogram', 'Hypotonia', 'Pulse absent', 'Respiratory arrest', 'SARS-CoV-2 test negative']",1,PFIZER\BIONTECH, 1101780,VA,89.0,M,Resident expired the next day,Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,03/11/2021,03/12/2021,1.0,SEN,Albuterol Sulfate Aerosol Powder Breath Activated 108 (90 Base) MCG/ACT 2 puff inhale orally every 6 hours as needed for sob/wheeze Biscolax Suppository 10 MG (Bisacodyl) Insert 1 suppository rectally every 24 hours as needed for constipat,"S/P hospitalization on 2/9 .89 yr old male with history of asbestos exposure, bladder urothelial malignancy,OSAS and not on cPAP at home,Dementia,Atrial fibrillation and s/p PPM placement,not on any anticoagulation,HTN,Chronic diastolic CHF,GERD,COPD/Emphysema was sent from first Facility in due to worsening mental status changes low blood pressure Altered mental status Patient with baseline dementia Patient was noted to be more lethargic and confused per staff CT head negative UA with trace leukocytes Patient awake however confused WBC 9 Extra lites reviewed show slightly elevated BUN TSH slightly elevated Free T4 Negative Dementia Hypotension in the emergency room at the time of presentation Blood pressure 80/67 Status post fluid bolus 500 cc Blood pressure soft Since does not feel like eating Continue gentle hydration at this time","F03.90 UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE 02/16/2021 Primary Admitting Admitting Dx (#69) I48.91 UNSPECIFIED ATRIAL FIBRILLATION 02/16/2021 Dx 2 I95.9 HYPOTENSION, UNSPECIFIED 02/16/2021 Dx 3 J44.1 CHRONIC OBSTRUCTIVE PULMONARY DISEASE WITH (ACUTE) EXACERBATION 02/16/2021 Dx 4 I50.32 CHRONIC DIASTOLIC (CONGESTIVE) HEART FAILURE 02/16/2021 Dx 5 G47.33 OBSTRUCTIVE SLEEP APNEA (ADULT) (PEDIATRIC) 02/16/2021 Dx 6 I25.10 ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT 02/16/2021 Dx 7 ANGINA PECTORIS E78.5 HYPERLIPIDEMIA, UNSPECIFIED 02/16/2021 Dx 8 F03.91 UNSPECIFIED DEMENTIA WITH BEHAVIORAL DISTURBANCE 02/17/2021 Dx 9 F41.1 GENERALIZED ANXIETY DISORDER 03/05/2021 Secondary During Stay J18.9 PNEUMONIA, UNSPECIFIED ORGANISM 03/05/2021 Secondary During Stay Z66 DO NOT RESUSCITATE 02/16/2021 Secondary Z95.0 PRESENCE OF CARDIAC PACEMAKER 02/16/2021 Secondary N40.0 BENIGN PROSTATIC HYPERPLASIA WITHOUT LOWER URINARY TRAC",,"Amoxicillin, Sotalol, Librium, Valium, Iodinated Diagnostic Agents, Penicillins, Statins, Sulfa Antibiotics, Lettuce, ATRACURIUM",['Death'],2,PFIZER\BIONTECH,IM 1101837,TX,67.0,M,"The patient became ill two days after the vaccination, and was hospitalized. He was diagnosed with COVID pneumonia on the 15th, and subsequently died.",Yes,03/03/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/12/2021,2.0,OTH,"Patient Medication List: tacrolimus, mycophenolic acid, prednisone, clonidine, coumadin, vascepa, carbamazepine, vitamin d3, hydroxyzine, nifedipine, carvedilol, rosuvastatin, sodium bicarb, pioglitazone, lantus, humalog, lisinopril.","Dehydration 2 days prior, treatted by Hospital","Kidney failure and resulting transplant, IDDM, hyperlipidemia, Htn",,Seasonal allergies only,"['COVID-19 pneumonia', 'Death', 'Malaise']",1,MODERNA,IM 1101884,NM,30.0,F,"History, patient received 1st COVID-19 Pfizer vaccine on 1/28/21 and 2nd Pfizer COVID-19 vaccine on 2/17/21 Unsure if any relation but patient was treated in our urgent care on 3/8/2021 18 day post receipt of 2nd COVID-19 vaccine unresponsive. Patient received ACLS support for unknown cause with suspected neurological/respiratory/cardiac complications. Patient was transferred to higher level of care.",Yes,03/10/2021,Not Reported,Yes,3.0,Not Reported,N,02/17/2021,02/17/2021,0.0,PVT,Unknown,None,None,,None,"['Blood glucose', 'Cardiac disorder', 'Drug screen', 'Full blood count', 'Metabolic function test', 'Neurological symptom', 'Respiratory disorder', 'SARS-CoV-2 test negative', 'Unresponsive to stimuli', 'Urine analysis']",2,PFIZER\BIONTECH,IM 1101924,TX,83.0,F,Tiredness first two days after injection Tongue swelling on 3/15/2021,Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/10/2021,03/13/2021,3.0,PHM,Unknown,Unknown,Unknown,,tongue swelling with ACE Inhibitors per reporting Physician on 3/15/2021 Latex - dermal reaction only (no issues with other vaccines),"['Fatigue', 'Swollen tongue']",1,JANSSEN,IM 1101941,TN,25.0,F,"Patient received Janssen vaccine by registered nurse and was completing her 15 minute waiting period. She began to feel faint and an employee of our facility caught her as she experienced a near syncopal episode. She was promptly placed in Trendelenburg position and vitals obtained. BP was 90/58 with mild tachycardia to max of 130-140 bpm. Patient was given supportive treatment and monitored. BP improved to 110/70 after 5 minutes and 120/72 after 15 minutes. Patient continued to feel very dizzy and weak, however, and became tachycardic and diaphoretic each time she attempted to move to a seated position. After 1 hour of monitoring and vitals showing continued tachycardia, decision was made to transport the patient to ER for further testing. Patient expressed agreement and understanding of plan to transport to ER via ambulance.",Not Reported,,Not Reported,Yes,,Not Reported,U,03/12/2021,03/12/2021,0.0,SCH,Hydroxyzine 10 mg 2 tabs by mouth four times daily as needed for anxiety (obtained from hospital records),History of tachycardia and possible atrial fibrillation per patient report,Tachycardia Anxiety,,NKA (obtained from hospital records),"['Asthenia', 'Blood thyroid stimulating hormone', 'Condition aggravated', 'Dizziness', 'Electrocardiogram', 'Fibrin D dimer', 'Full blood count', 'Hyperhidrosis', 'Metabolic function test', 'Pregnancy test', 'Presyncope', 'Tachycardia', 'Thyroxine', 'Troponin']",1,JANSSEN,IM 1101959,MI,65.0,M,He passed on 02/06/2021,Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,02/06/2021,3.0,UNK,Vitamins Prilosec (Other medications but unknown at the moment- will call back),No,High Cholesterol,,No,['Death'],1,MODERNA,SYR 1101990,FL,39.0,F,"Dizziness, sweating, blacked out, blood pressure dropped",Not Reported,,Not Reported,Yes,1.0,Not Reported,Y,03/14/2021,03/14/2021,0.0,PHM,,,,,,"['Blood pressure decreased', 'Dizziness', 'Hyperhidrosis', 'Loss of consciousness']",1,JANSSEN,IM 1101991,NY,97.0,F,"In ED on 2/25/21 Chief complaint: Patient's daughter present at bedside stating patient was not vocalizing this morning when she woke up. Patient's daughter was talking to her and she would orient to her but not answer any of her questions. EMS called and by the time they arrived patient was acting her normal self. Daughter states she has had a very difficult time managing patient's behaviors over the last several weeks and it has been getting more difficult. Daughter states that over the last several weeks her behaviors have been worsening and been more difficult to deal with. These include her getting up at night and sundowning as well as yelling and screaming during the day. Daughter states that she gets in the shouting matches with the patient during the day. Daughter breaks down and starts to cry when discussing that she thinks her mother will need long-term placement as she is having a difficult time dealing with her behaviors. Of note patient did receive second dose of Covid vaccine yesterday. -Patient has not been complaining of any symptoms over the last several days and daughter has not noticed cough or congestion or other signs of URI/illness -No focal neurologic deficits on exam -Received 1L IV NS in ED 2/26/21 Covid positive, incidental finding ? tested so she could go to nursing facility -Patient asymptomatic -Vital signs stable, afebrile -She does not need treatment at this time -She will need a repeat Covid test 14 days after the original Covid test prior to going to SNF -Plan- discharge to skilled nursing facility Discharge summary Principal Problem: Comfort measures only status Active Problems: Chronic atrial fibrillation Essential hypertension Dementia with behavioral disturbance Recurrent falls Dysphagia COVID-19 Resolved Problems: Cough with hemoptysis Leukocytosis Dehydration Inadequate oral intake Patient is a 97-year-old female with a past medical history of dementia, likely combined vascular/Alzheimer's, hypertension, chronic A. Fib, who presented to the ED on 2/25/2021 due to behavioral disturbance as well as need for long-term care placement due to progressive dementia. She did have an incidental positive Covid test on 2/26/2021 and was planned for discharge to COVID recovery ward of SNF. She did not require medication or oxygen treatment for COIVD-19. She developed tachycardia/tachypnea and cough later productive for blood after suctioning attempts overnight on 2/28-3/1, which did not recur. Unfortunately, patient's overall function declined after, and she was refusing/unable to eat or drink. She was transitioned to comfort care status on 03/03/2021. She eventually slipped into persistent sleep with lack of responsiveness on 3/4/2021. Comfort care was provided. She had decreased urinary utput and respiratory function indicating expected progression. She was noted to not have a heart rate on 03/08/2021. Auscultation did not reveal any breath sounds or heart sounds; unable to palpate pulse; no pupillary response to light was seen; and patient did not respond to painful stimuli. Death was pronounced on 03/08/2021, 02:58am. Deceased 3/8/21",Yes,03/08/2021,Not Reported,Yes,11.0,Not Reported,N,02/24/2021,02/25/2021,1.0,UNK,acetaminophen (TYLENOL) cholecalciferol (VITAMIN D3) 1000 UNITS capsule desoximetasone (TOPICORT) 0.25 % cream digoxin (LANOXIN) 125 MCG tablet divalproex (DEPAKOTE) 250 MG EC tablet furosemide (LASIX) 40 MG tablet metoprolol succinat,Abnormal behavior,Arthritis Atrial fibrillation Hypertension Dementia without behavioral disturbance Recurrent falls Cholecystectomy,,None known,"['Abnormal behaviour', 'Atrial fibrillation', 'Blood thyroid stimulating hormone normal', 'Breath sounds absent', 'COVID-19', 'Chest X-ray normal', 'Coagulation test normal', 'Cough', 'Death', 'Dehydration', 'Delirium', 'Dementia', 'Diet refusal', 'Disorientation', 'Dysphagia', 'Electrocardiogram abnormal', 'Essential hypertension', 'Fall', 'Fibrin D dimer', 'Full blood count normal', 'General physical health deterioration', 'Haemoptysis', 'Hypersomnia', 'Hypophagia', 'Leukocytosis', 'Metabolic function test normal', 'Pulse absent', 'Pupillary light reflex tests abnormal', 'Pupillary reflex impaired', 'Respiratory disorder', 'SARS-CoV-2 test positive', 'Screaming', 'Tachycardia', 'Tachypnoea', 'Thyroxine free normal', 'Troponin I normal', 'Unresponsive to stimuli', 'Urine analysis normal', 'Urine output decreased', 'Ventilation/perfusion scan']",2,PFIZER\BIONTECH,UN 1102077,FL,97.0,M,My father was old and frail but was not sick prior to the vaccine. The day after receiving the shot he developed a fever. This spiked during the day and he stated he didn't feel good. He became nauseous after dinner. He began vomiting during the early evening and passed away at approximately 10:00pm that night.,Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/05/2021,1.0,OTH,,,My father was old and frail but otherwise healthy for a 97 year old. He developed a fever and died the day after the vaccination.,,None,"['Death', 'Feeling abnormal', 'Nausea', 'Pyrexia', 'Vomiting']",2,MODERNA,SYR 1102080,OH,36.0,F,"3-11-21 C/O RASH TO BOTH LEGS & ABD SINCE 9:30AM. NO SOB OR DYSPNEA. 1:42PM BENADRYL 50MG GIVEN PO. STATES SHE WILL SPEND THE REST OF THE WORK DAY SITTING DOWN AND HUSBAND WILL DRIVE HER HOME. 3-15-21 10:46AM: STATES SHE DID GO TO ER X2, FACILITY ADMITTED HER FOR VASCULITIS X1DAY. 'THOUGHT IT MAY BE A DELAYED VACCINE REACTION.' RASH ON LEGS, ABD & NOW FOREARMS IS NOW 'PURPLE'. HAD LOTS OF JOINT PAIN ALSO. SHE WAS GIVEN SOLUMEDRAL AND PREDNISONE AND IS FEELING BETTER NOW, WILL RETURN TO WORK TOMORROW.",Not Reported,,Not Reported,Yes,1.0,Not Reported,N,03/04/2021,03/10/2021,6.0,PUB,,,,REACTION TO MMR VACCINE,"SULFA, PCN, 'SEASONAL'","['Arthralgia', 'Rash', 'Skin discolouration', 'Vasculitis']",1,JANSSEN,IM 1102082,OH,77.0,F,"Acute Myocardial Infarction due to severe dysphagia, odynophagia, cachexia, fluid and electrolyte abnormalities, due to advanced dementia",Yes,03/03/2021,Yes,Not Reported,,Not Reported,N,02/26/2021,03/02/2021,4.0,PHM,"Levothyroxine, Losartan Potassium, Women's multivitamin, probiotic, baby aspirin, Metformin, Memantine, Mirtazapine",Dysphagia,"Dementia, Diabetes type 2, hypertension,",,Penicillin,"['Acute myocardial infarction', 'Cachexia', 'Condition aggravated', 'Dementia', 'Dysphagia', 'Electrolyte imbalance', 'Odynophagia', 'Ultrasound scan', 'X-ray']",2,MODERNA,SYR 1102117,NE,85.0,F,"Meniere's attack; Anaphylactic reaction; Started passing out; doesn't feel well; Tired; light headed; A spontaneous report was received from a Consumer concerning a 85 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction (anaphylactic reaction), started passing out (loss of consciousness), Meniere's attack (Meniere's disease), tired (fatigue), light headed (dizziness) and doesn't feel well (malaise). The patient's medical history included allergies to citrus and bee stings. Concomitant product use was not provided by the reporter. On 15 FEB 2021, immediately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 15 FEB 2021, immediately post vaccination, the patient got an anaphylactic reaction and started passing. The patient was transported to the emergency room where medication was administered and an echocardiogram (ECG) was performed (results not provided). On 17 FEB 2021, the patient contacted physician who instructed to take Tylenol three times a day and nausea medication as needed. The patient only took one pill. On 21 FEB 2021, the patient had a terrible Meniere's attack which caused patient to feel dizzy and was hospitalized. On an unknown date in FEB 2021, the patient returned home but couldn't get over it. Patient reported feeling very tired, lightheaded and unwell. Treatment information included famotidine, Ativan, Zofran, Tylenol and nausea medication. Action taken with mRNA-1273 in response to the events was unknown. The events Meniere's attack, tired, lightheaded and doesn't feel well were considered not resolved. The event started passing out was considered resolved on 15 FEB 2021. The outcome of the event anaphylactic reaction was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/15/2021,02/01/2021,,UNK,,Allergy to insect sting; Fruit allergy (Citrus),,,,"['Anaphylactic reaction', 'Dizziness', 'Fatigue', ""Meniere's disease"", 'Presyncope', 'Vaccination complication']",1,MODERNA,OT 1102123,,,F,"tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable nurse, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, after the first dose of the vaccination, the patient tested positive for COVID-19. She questioned if she can take the 2nd dose of the vaccine (her schedule would be more than 21 days). The clinical outcome of tested positive for COVID-19 was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 25Jan2021, and tested positive for the virus (COVID-19) on an unspecified date. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection. Further information like COVID infection date needed for a full meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1102130,ID,72.0,M,"Woke up with subconjunctival hemorrhage in left eye; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6198), via an unspecified route of administration into the left arm on 26Feb2021 09:15 at a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis. The patient's concomitant medications were not reported. Patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN9581), via an unspecified route of administration into the left arm on 05Feb2021 09:30 at a single dose for COVID-19 immunization. The patient woke up with subconjunctival hemorrhage in left eye on 28Feb2021 06:00. The patient did not receive treatment for the event reported. Outcome of event was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/26/2021,02/28/2021,2.0,SCH,,,Medical History/Concurrent Conditions: Psoriatic arthritis,,,['Conjunctival haemorrhage'],2,PFIZER\BIONTECH, 1102132,,87.0,M,"patient was admitted for covid-19, CTA positive for covid-19 pneumonia and covid-19 PCR positive, after 2 completed doses of Pfizer vaccine.; patient was admitted for covid-19, CTA positive for covid-19 pneumonia and covid-19 PCR positive, after 2 completed doses of Pfizer vaccine.; covid-19 pneumonia; This is a spontaneous report from a non-contactable other HCP. An 87-year-old male patient received on an unknown date the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot unknown) and on 11Feb2021 the second dose (30mcg/0.3mL, lot unknown), both via an unspecified route of administration for COVID-19 immunization (age at vaccination 87-year-old). Medical history included: Chronic lymphocytic leukaemia (CLL) and hypogammaglobulinemia. Concomitant medication was not reported. The patient was recently admitted for covid-19, CTA positive for covid-19 pneumonia and covid-19 PCR positive, after 2 completed doses of Pfizer vaccine. On 23Feb2021 (post vaccination), the patient's COVID test nasal swab was positive. Patient did not have COVID prior vaccination. Outcome of events was unknown. No follow-up attempts are possible; information about Lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Covid-19 , COVID 19 pneumonia and vaccination failure due to temporal relationship.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,OTH,,,Medical History/Concurrent Conditions: CLL; Hypogammaglobulinemia,,,"['Angiogram', 'COVID-19', 'COVID-19 pneumonia', 'SARS-CoV-2 test', 'Vaccination failure']",1,PFIZER\BIONTECH, 1102133,PA,,M,"COVID positive; COVID positive; a little tenseness in his arm; This is a spontaneous report from a contactable consumer (patient) and from same contactable consumer (patient) via Pfizer-sponsored program. A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on 01Feb2021 about noon for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Feb2021 maybe 11pm that night as he raised his arm, he could feel a little tenseness in his arm. On 23Feb2021, he was diagnosed COVID positive, he tested positive for COVID but has no symptoms. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive. The outcome of events was unknown. The patient was due to have his 2nd dose on 03Mar2021. The patient asked if he should still take the 2nd dose. A product complaint was filed. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,,,,,"['Asymptomatic COVID-19', 'Drug ineffective', 'SARS-CoV-2 test positive', 'Tenderness']",1,PFIZER\BIONTECH, 1102244,LA,72.0,F,Patient expired on 02/26/2021 from a Myocardial Infarction,Yes,02/26/2021,Not Reported,Not Reported,,Not Reported,N,02/25/2021,02/26/2021,1.0,PHM,,,,,,"['Death', 'Myocardial infarction']",2,MODERNA,IM 1102308,DE,67.0,M,"Pt received Pfizer COVID Vaccine 3/9/21 at 13:25 At Clinic. Lot #EN6205 Exp 6/21 to right deltoid. No issues noted while patient dialyzing. Pt came off treatment 16mns early due to concerns of transportation. Pt a/o, VSS, pt in W/c no issues noted at discharge. Pt's comorbid conditions per hospital discharge records: <20% EF, deteriorating health status, physician recommended hospice care but pt refused. On March 11th, significant other notified facility that patient had passed away in his sleep and was found by workers at the rehab facility he was in.",Yes,03/11/2021,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/11/2021,2.0,OTH,,"Documented deteriorating health status, ESRD",Cardiac ejection fraction <20%,,,"['Death', 'Dialysis']",1,PFIZER\BIONTECH,IM 1102443,CO,90.0,M,On 2/18/2021 the resident spiked a fever of 101.7 and had decrease oxygen saturation down to 86% with a cough. The resident was transferred to the ER for evaluation. Per Advanced Directives resident was not treated with antibiotics and returned to the Nursing Home on 2/19/2021. The resident had several episodes of emesis and was placed on comfort measures. He dised on 2/25/2021.,Yes,02/25/2021,Not Reported,Not Reported,,Not Reported,N,01/27/2021,02/18/2021,22.0,SEN,"Abilify Tablet 5 MG (ARIPiprazole), Donepezil 10 mg HCl Tablet, Finasteride 5 mg Tablet, Levothyroxine Sodium Tablet 75 MCG, Lidoderm Patch 5 % (Lidocaine), Loratadine Tablet 10 MG, MiraLax Powder (PolyethyleneGlycol 3350) 17 gram, Omeprazo",The resident had dementia and was requiring increase assistance. The resident had been experiencing weight loss over the past few months. The resident was medicated for chronic pain.,The resident was wheelchair bound and dependent on staff for care.,,Pregabalin,"['Blood lactic acid normal', 'Brain natriuretic peptide increased', 'Computerised tomogram thorax', 'Cough', 'Death', 'Fibrin D dimer increased', 'Lung opacity', 'Oxygen saturation decreased', 'Pyrexia', 'Troponin normal', 'Urine analysis normal', 'Vomiting']",1,MODERNA,IM 1102547,MI,64.0,F,"Janssen COVID vaccine was administered on 3/13/21- patient was screened twice and denied receiving any vaccines in the past 2 weeks. after administration it was noted today (3/15/21) that the patient received the Moderna COVID vaccine (one dose) on 3/4/21. I attempted to reach out to patient to discuss and noted that she is admitted to Hospital for a NSTEMI. Per chart notes patient reported symptoms of fever, nausea, malaise on 3/13/21 after vaccination. The next day 3/14/21 developed syncope and chest pain. Patient reported to emergency room and was admitted with NSTEMI",Not Reported,,Not Reported,Yes,,Not Reported,U,03/13/2021,03/14/2021,1.0,PVT,"levothyroxine 125 mcg daily, Lisinopril 30mg daily, singulair 10mg daily, Prilosec 20mg daily, Effient 10mg daily, crestor 40mg daily, Zoloft 200mg daily, ALLEGRA 180 mg daily, Ipratropium Bromide (solution) ATROVENT 0.02 % Take 2.5 mL (5",,"Hypertension Hyperlipidemia Asthma Insomnia Seasonal allergies CAD (coronary artery disease) Sleep apnea, obstructive Atrophic vaginitis Microhematuria Kidney stone on left side SLE (systemic lupus erythematosus) Seasonal affective disorder Generalized anxiety disorder Major depressive disorder, recurrent episode, in full remission Dysthymic disorder Vitamin D deficiency Hypothyroidism due to acquired atrophy of thyroid S/P CABG x 2 10/26/2017 Renal artery stenosis (*) Obesity (BMI 30.0-34.9)",,"latex- rash, sulfa antibitotics","['Acute myocardial infarction', 'Chest pain', 'Malaise', 'Nausea', 'Pyrexia', 'Syncope']",,JANSSEN,IM 1102572,TX,87.0,M,Was notified by a third party that patient died on morning of 3/15/2021. No other information available.,Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,03/12/2021,03/15/2021,3.0,PVT,"Clobetasol 0.05% topical ointment, fluocinonide 0.05% topical cream, atorvastatin, daily multi-vitamin, glimepiride, metformin, clonidine transdermal, coumadin, folic acid, furosemide, hydralazine","arthritis, atrial fibrillation, congestive heart failure, diabetes mellitus, high cholesterol levels, hypertension",aortic valve replacement,,no known drug allergies,['Death'],1,JANSSEN,IM 1102698,NM,83.0,F,Death 5 days after 2nd Pfizer vaccine,Yes,02/16/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/15/2021,5.0,PUB,"Heart meds, daily vitamins, fish oil, Lyrica","Thyroid, heart issues","Thyroid, heart",,None,['Death'],2,PFIZER\BIONTECH,SYR 1102714,SC,32.0,F,Janssen COVID-19 Vaccine EUA,Not Reported,,Yes,Yes,1.0,Not Reported,N,03/07/2021,03/07/2021,0.0,PHM,Sulfasalazine Ortho-Cyclen,None,Currently meeting with rheumatologist for possible juvenile rheumatoid arthritis.,,None,"['Anaphylactic reaction', 'Blood test']",1,JANSSEN,SYR 1102722,FL,81.0,F,Patient presented to Hospital ED on 3/14/21 with respiratory distress. Patient was tested for COVID-19 and found to be positive on 3/14/21 in the hospital ED. Patient was a DNR. Hospice was consulted (this writer is employed by Hospice). The patient passed away on 3/15/2021. Per family patient had recently received COVID-19 vaccine. Vaccine information verified in portal.,Yes,03/15/2021,Not Reported,Not Reported,,Not Reported,N,03/03/2021,03/14/2021,11.0,PHM,Unknown,PARKINSON'S DISEASE,"Parkinson's Disease, Hyperthyroidism, AFIB, Deprsn, Anxiety, DVT",,NO KNOWN ALLERGIES,"['COVID-19', 'Death', 'Respiratory distress', 'SARS-CoV-2 test positive']",1,MODERNA,IM 1102736,WA,77.0,M,"Spouse of an existing client signed up for a COVID-19 vaccination and received his first injection of Moderna on 03/07/21 by ARNP. He denied any symptoms of illness, including COVID-19, on the vaccination date. He was educated re: possible side effects and adverse effects and was asked to report any such effects; no interim contact received. This provider's office called the existing client on 03/15/21 with a routine matter and was advised that this individual had passed away the preceding day. This provider spoke to the existing client, who reported that the cause of death is unknown. The existing client did not believe that her spouse's death and the vaccination were related. She was asked to notify this provider if any further information is discovered and agreed to do so.",Yes,03/14/2021,Not Reported,Not Reported,,Not Reported,N,03/07/2021,03/14/2021,7.0,PVT,,,,,,['Death'],1,MODERNA,IM 1102754,VA,57.0,F,"Patient contacted her employer 2 days after vaccination with complaint of new onset rash. Was seen by her PCP and was reportedly being treated for Shingles. Missed work week of 8-12 March for same. When didn't report to work today (3/15/21), supervisor went to home to conduct a safety check and found the patient dead in her home.",Yes,03/15/2021,Not Reported,Not Reported,,Not Reported,N,03/02/2021,03/04/2021,2.0,PVT,,,,,,"['Death', 'Herpes zoster', 'Impaired work ability', 'Rash']",1,PFIZER\BIONTECH,IM 1102800,TN,83.0,M,"Patient received a covid vaccine on 03/05/2021. Daughter reports there were no side effects that night or the following days. The next Saturday, March 13, 2021, the daughter was at her parents house checking up on them. Her father was in the bathroom as she passed in the hall. He came out of the bathroom and proceeded to the living room, she stated dad are you ok? He said he couldn't breath. Giving his history of COPD and being short of breath sometimes, she didn't think anything of it. She proceeded to follow him to his chair and was checking his oxygen tank that he had been using with ambulation. It still had some in the tank. She raised her head to tell him he still had some in the tank and saw that he had started ""agonal breathing"". Daughter is a nurse and knew he needed help. She phone for an ambulance and with the help of her mother got patient to the floor and started CPR. Paramedics arrived on scene, continued CPR and administered meds and also intubated, but were unsuccessful in their efforts.",Yes,03/13/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/13/2021,8.0,PUB,LOSARTAN 25 MG DAILY SPIRONALACTONE 25 MG DAIL ELIQUIS 5MG BID ASA 81MG DAILY ATORVASTATIN 20MG DAILY IRON 325MG DAILY FINASTERIDE 5MG DAILY GABAPENTIN 300MG DAILY MELATONIN 3MG DAILY LASIX 40MG BID- PRN VIT B12 INJECTION 1ML MONTHLY BENAD,,COPD CAD CHF,,,"['Agonal respiration', 'Death', 'Dyspnoea', 'Endotracheal intubation', 'Resuscitation']",2,MODERNA,IM 1102815,MO,87.0,F,"Patient presented to hospital on 3/11 with shortness of breath. History of chronic oxygen dependency at night. Became more sob over last several days and was not able to make it to md appointment. Had a recent abnormal stress test. Family states she was febrile at home. Was low on oxygen level on 2LNC, placed on non-rebreather and then BIPAP. Positive for Rhinovirus. Chest xray showed bilateral lower infiltrates. Patient detiorated through the night and was intubated and placed on vasopressors for septic shock. Patient was made DNR and family refused hemodialysis. Family then made decision to withdraw care.",Yes,03/12/2021,Not Reported,Yes,2.0,Not Reported,N,03/05/2021,03/09/2021,4.0,PUB,"Advair, Alprozolam, Amlodipine, Aspirin, Atorvastatin, Azithromycin, Biotin, Cefuroxime, Dexilant, Dymista, Fenofibrate, Fluticasone, Hydrochlorothiazide, Incruse Ellipta, Isosorbide Monoitrate, Levothyroxine, Lipitor, Loratadine, Magnesium","2-3 weeks prior to vaccine was croupy and saw a pulmonologist and lungs were clear, on and off antibiotics from 2/12 to 3/5, failed stress test (occlusion of left anterior descending artery) and recommended cardiac cath and had a cardiac implant, possibly defibrillator.","COPD and Diastolic CHF, Pre-Diabetic, Hypertension",,Penicillin,"['Bilevel positive airway pressure', 'Blood lactic acid increased', 'Dyspnoea', 'Endotracheal intubation', 'General physical health deterioration', 'Human rhinovirus test positive', 'Lung infiltration', 'Oxygen saturation decreased', 'Procalcitonin increased', 'Pyrexia', 'Refusal of treatment by patient', 'Rhinovirus infection', 'Septic shock', 'Vasopressive therapy']",1,JANSSEN,IM 1103055,IN,66.0,M,Patient wife called on 3/11/21 to state that she would like us to cancel her husband second dose appointment for his COVID-19 Moderna vaccine. Wife stated that 24 hours after receiving vaccine patient died. Hospital told patient wife that it could be due to receiving COVID-19 vaccine. Unable to get anymore pertinent information from patient representative.,Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/23/2021,02/24/2021,1.0,PHM,None on intake form,None stated,None stated,,None stated,['Death'],1,MODERNA,IM 1103106,MS,80.0,M,Patient died on 01/24/2021. Began exhibiting symptoms similar to Covid 1 day after vaccination.,Yes,01/24/2021,Not Reported,Yes,3.0,Not Reported,N,01/15/2021,01/16/2021,1.0,UNK,UNK,,,,,"['Death', 'Malaise']",1,JANSSEN,SYR 1103186,MI,70.0,F,"Patient was vaccinated with the Pfizer vaccine in early February. On February 19th, she was diagnosed with Acute Myeloid Leukemia",Yes,02/23/2021,Not Reported,Yes,4.0,Not Reported,N,02/01/2021,02/19/2021,18.0,PVT,"cephalexin, diltiazem, warfarin",statin--muscle weakness,,,,"['Acute myeloid leukaemia', 'Biopsy bone marrow', 'Full blood count']",2,PFIZER\BIONTECH,IM 1103192,CA,78.0,M,Patient passed in his sleep 5 days after receiving first dose of Moderna,Yes,03/14/2021,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/14/2021,5.0,PVT,"Baclofen 10 mg, diazepam 5 mg, Meloxican 15 mg, Omeprazole 20 mg, hydromorphone 4 mg.",Chronic pain and neurologic dysfunction due to multiple traumas,Pain and neurologic dysfunction,,No known allergies,['Death'],1,MODERNA,IM 1103241,NC,97.0,M,"On 01 February 2021 a 97 year old male was administered the Pfizer COVID vaccine. Side effects began as fatigue and difficulty communicating. On 08 February 2021 the male became bedridden and developed a fever with chills. Over the next few days he struggled to eat, drink, and eventually to breath. The 97 year old died 25 February 2021.",Yes,02/25/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/09/2021,8.0,PVT,"Gabapenten, Dilantin, prednisone, k-flex, finastride. He had some supplements he took. Psyllium and potassium chloride. He also had the ativan, tessalon pearles, tussionex syrup, and metanx for neuropathy.",Skin infection treated with antibiotics.,Melanoma on leg.,,None known,"['Bedridden', 'Chills', 'Communication disorder', 'Death', 'Dyspnoea', 'Fatigue', 'Feeding disorder', 'Hypophagia', 'Pyrexia']",UNK,PFIZER\BIONTECH, 1103347,TX,85.0,F,"At 2 PM Friday, March 12, patient was cleaning house and began speaking incoherently. Due to the aphasia, her daughter called 911. The ambulance delivered her to Hospital by 2:20. She presented with a brain hemoragh. Hospital called for medivac which took her to another Hospital. The bleeding continued and the docs ruled out surgery. They were unable to slow the bleed. Patient was put on a ventilor shortly after arriving at hospital. Patient passed at 6:55 PM March 13.",Yes,03/13/2021,Yes,Yes,,Not Reported,N,03/11/2021,03/12/2021,1.0,PUB,There are many. I do not have them with me.,"ITP. macular degeneration, congestive heart failure",see above,,,"['Aphasia', 'Cerebral haemorrhage', 'Death', 'Incoherent', 'Mechanical ventilation']",1,MODERNA,IM 1103366,MO,22.0,F,"Arms tingling, throat tingling, short of breath, palpitations brain fog ,weakness , chest pain , chest pressure, anxiety, still with intermittent numbness, tingling face , weakness.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/24/2021,02/24/2021,0.0,PUB,Tri sprintec,Cardiomyopathy,Cardiomyopathy,,"Penicillin, Cefzil, Minicycline","['Anxiety', 'Asthenia', 'Chest discomfort', 'Chest pain', 'Dyspnoea', 'Electrocardiogram ambulatory', 'Feeling abnormal', 'Hypoaesthesia', 'Palpitations', 'Paraesthesia', 'Pharyngeal paraesthesia']",1,MODERNA,IM 1103656,TX,66.0,M,"Patient was found deceased in garage. Neighbor who is a nurse did CPR until ambulance got there and took over, started IVs and pushed medicine and did CPR as well. Patient was pronounced deceased over th ephone with the JP and Police due to the icy weather conditions on Feb 16th 2021",Yes,02/16/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/16/2021,6.0,OTH,Plavix 75mg. CoQ10. Gabapentin 300mg. Olmesartan 20mg. Pantoprazole 40mg. Rosuvastatin 20mg Aspirin 81mg. Doxycycline. Ipatropium,,High blood pressure High cholesterol Acid reflux History of blood clots History of heart attack twice in 2002,,Penicillin,"['Death', 'Resuscitation']",2,MODERNA, 1104431,,83.0,M,"Cardiac arrest Narrative: An 82 year old, male, resident of a facility, received his first dose of the Pfizer COVID vaccine on 12/30/20 (time of dose not known). On 12/31/20, patient was reported to be febrile with increased lethargy and UTI was suspected so patient received a dose of ceftriaxone and levofloxacin. Within 30 minutes he became wheezy and short of breath, developed hives and tongue swelling. He required intubation and admission for treatment of acute respiratory failure, acute kidney injury and significant lactic acidosis. Treatment included epinephrine, H1 and H2 blockers, and steroids. He recovered and was extubated on 1/3/21 and discharged back to the facility on 1/6/21. Attending physician noted that antibiotics were most likely contributor to event, but recommended that patient not receive the 2nd COVID vaccine dose. Patient was referred to an allergist to assess this event, with an outpatient visit on 1/14/21. Patient expressed interest in receiving the 2nd dose. Allergist determined that the antibiotics were the cause of anaphylaxis, and recommended skin testing to take place 6 weeks after his reaction. Allergist determined the reaction was not due to the COVID vaccine and advised patient that he could receive the 2nd dose. Patient received the 2nd dose of the Pfizer COVID vaccine on 1/9/21 (time not known). Notes from the facility indicate patient was lethargic and running a fever the morning of 1/20/21. At 1500 on 1/20/21 patient was noted to be lying supine in bed, visiting with aides. At 1508 nurse entered room and noted patient to be lying on floor supine and nurse was unable to get patient to respond to shaking or calling his name. Breathing was noted to be labored, and nurse was unable to detect a pulse. At 1509, 911 was called and CPR initiated. Spontaneous pulse and breathes resumed just before ambulance arrived at 1522. On arrival at the ED patient was responsive and breathing spontaneously, however, hemodynamically unstable. Patient went into cardiac arrest and code blue called at 1535. Received treatment with epinephrine, methylprednisolone, diphenhydramine, amiodarone, atropine. Patient was intubated. EKG obtained and showed acute MI. At 1622 he again went into cardiac arrest and time of death was called.",Yes,01/20/2021,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/20/2021,1.0,OTH,,,,,,"['Acute myocardial infarction', 'Aspartate aminotransferase increased', 'Blood albumin decreased', 'Blood calcium decreased', 'Blood creatinine increased', 'Blood glucose normal', 'Blood sodium decreased', 'Blood urea normal', 'Carbon dioxide decreased', 'Cardiac arrest', 'Death', 'Dyspnoea', 'Electrocardiogram abnormal', 'Endotracheal intubation', 'Glomerular filtration rate decreased', 'Haematocrit decreased', 'Haemodynamic instability', 'Haemoglobin decreased', 'Lethargy', 'Platelet count decreased', 'Pulse absent', 'Pyrexia', 'Red blood cell count decreased', 'Red cell distribution width increased', 'Resuscitation', 'Unresponsive to stimuli', 'White blood cell count increased']",2,PFIZER\BIONTECH,IM 1103619,IN,71.0,M,"URINARY TRACT INFECTION; pink in my urine; Little bit of Pain after injection in left arm; A spontaneous report was received from a 71 years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection (urinary tract infection), pink in my urine (chromaturia) and little bit of pain in arm of injection (pain in extremity). The patient's medical history was not provided. The relevant concomitant medications were also not provided. On 02 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number:013M20A ) through intramuscular route of administration in the left arm for prophylaxis of COVID-19 infection. On 02 Feb 2021, patient experienced little bit of pain in arm of injection. On 23 Feb 2021, patient experienced pink in urine. The patient subsequently visited the urgent care on 26-Feb-2021 and was diagnosed with a urinary tract infection. Treatment for urinary tract infection included ciprofloxacin 500 mg twice daily for 7days. No laboratory data was provided. Action taken with mRNA-1273 in response to the events was not reported. The event little bit of pain in arm of injection was resolved 03 Feb 2021. The event pink in urine was resolved on 01 Mar 2021. The outcome of the event urinary tract infection was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (vaccination site pain) a causal relationship cannot be excluded. However, for the events - chromaturia and UTI, a very limited information has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/02/2021,02/02/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Chromaturia', 'Urinary tract infection', 'Vaccination site pain']",1,MODERNA,OT 1103621,VA,,M,"pneumonia; sick; chills; headache; body aches; rash; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. Medical history included rash which he gets anytime of the year. Concomitant medications were not reported. The patient had the first shot and got sick eight days later. He was in the hospital for two days and saw his primary doctor when he got out. The doctor told them that everything with the blood tests was good, and also with his kidneys, then he prescribed medication for pneumonia. With the first dose of the vaccine, the patient also experienced chills, headache and a little body aches without fever. When he came home from the hospital, the patient had a rash. Outcome of the events was not reported. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Rash,,,"['Blood test', 'Chills', 'Headache', 'Malaise', 'Pain', 'Pneumonia', 'Rash']",1,PFIZER\BIONTECH, 1103630,,,F,"she tested positive with Covid after the first dose; She tested positive with Covid after the first dose; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A non-contactable consumer (patient) reported that that a female patient of unspecified age received the first dose of BNT162B2 (BNT162B2, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported she tested positive with COVID after the first dose on an unspecified date. Outcome of the events was unknown. No follow up attempts are possible; information regarding Lot/Batch cannot be obtained.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Drug ineffective', 'SARS-CoV-2 test', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH, 1103635,,,U,"not feeling good/sick/Covid-19 positive; not feeling good/sick/Covid-19 positive; This is a spontaneous report from a contactable consumer (the patient). A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration on 24Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had an appointment next Tuesday (16Feb2021) for their second dose, but they were not feeling good. The doctor said the patient was COVID-19 positive, so the patient wanted to cancel that and reschedule the appointment for next time. The patient got sick and took a COVID test, and the doctor said the patient was positive (on an unspecified date). The patient asked if they could get the second dose since they were sick. The clinical outcome of not feeling good/ sick/ Covid-19 positive was not recovered. Information about lot number was requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/24/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1103636,,78.0,M,"He has had a friable capillaries, so sometimes when he urinate, he urinate blood or little blood clots; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6198), via an unspecified route of administration on 24Feb2021 at a single dose for COVID-19 immunization and apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for Atrial Fib (atrial fibrillation). Medical history included prostate cancer from about 10 years ago and was treated by radiation, the radiation has caused capillaries in the penis to be fragile (friable capillaries) and there were times when he bleeds and has some clots and it usually resolves itself; and bloody urine in the past. The patient's concomitant medications were not reported.. Radiation has caused capillaries in the penis to be fragile and there are times when he bleeds and has some clots. The patient has had a friable capillaries, so sometimes when he urinates, he urinate blood or little blood clots. The patient was on Eliquis, so yesterday when they came home after he got the vaccine, he was bleeding with the clots which he has done in the past. The reporter asked if it is possible that the vaccine can precipitate a bleeding episode in someone that is on Eliquis and had on and off had bloody urine in the past. After the shot, he was bleeding with the clots and with the bloody urine. The patient got the first dose of the Pfizer COVID-19 vaccine on Wednesday. He had radiation for prostate cancer 10 years ago. He had a bloody urine periodically and the doctors were aware. He had a blood urine one hour post vaccination in 24Feb2021. It would take at least a few hours for the medication to get in the system before having any kind of reaction. It resolved on its own he doesn't have a blood urine anymore. The second dose of the vaccine is due on 16Mar2021. The action taken in response to the events for apixaban was unknown. The outcome of the events was recovered on unspecified date in Feb2021.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/24/2021,02/24/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Bleeding genital; Blood urine present; Capillary fragility (friable capillaries); Clot blood; Prostate cancer; Radiation therapy,,,['Haemorrhage urinary tract'],UNK,UNKNOWN MANUFACTURER, 1103638,DC,41.0,M,"diffused rash with initial derm bx suggesting bullous em; diffused rash with initial derm bx suggesting bullous em; This is a spontaneous report from a contactable physician. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported) (at 41 years of age), via an unspecified route of administration on 08Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines four weeks prior to Covid vaccine. The patient experienced diffused rash with initial derm bx suggesting bullous em but repeat biopsy is pending. Multiple infection work up (w/u) negative, more esoteric immune work up (w/u) pending. The events occurred on 19Feb2021 with outcome of recovering. The patient was hospitalized for seven days due to the events. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Yes,7.0,Not Reported,N,02/08/2021,02/19/2021,11.0,UNK,,,,,,"['Biopsy skin', 'Erythema multiforme', 'Investigation', 'Rash']",UNK,PFIZER\BIONTECH, 1103645,IN,,F,"Pneumonia; A spontaneous report (United States) was received from a consumer concerning about a 70 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia. The patient's medical history included smoking. Concomitant medications were not reported. On 04 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A) via intramuscular for prophylaxis of COVID-19 infection. On 28 Feb 2021 the patient had pneumonia and she hospitalized for that. But the reporter states that pneumonia was not related to the vaccine, but it might be due to cold temperatures and the patient smokes too. Laboratory tests was not reported. Treatment information was unknown. All the events occurred after first dose of vaccination. Action taken with mRNA-1273 in response to the events are unknown. The outcomes of all the events remain unknown.; Reporter's Comments: The events were consistent with increased risk of infections associated in pandemic set up confounded by elderly age of patient. Company assessed the events to be unlikely related to company product.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/04/2021,02/28/2021,24.0,UNK,,Smoker,,,,['Pneumonia'],1,MODERNA,OT 1103708,AZ,82.0,M,"Diarrhea, Stiff Neck, Overall feeling not well, Loss of strength",Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,N,01/26/2021,01/28/2021,2.0,SEN,"Loratadine, Atorvastatin, Famotidine, Aspirin, Ranitidine, Rena-vite,","Pulmonary Fibrosis, Diabetes",Same as above,,Unknown,"['Asthenia', 'Diarrhoea', 'Malaise', 'Musculoskeletal stiffness']",1,MODERNA,IM 1103748,AL,76.0,F,Cardiac Arrest/Death,Yes,03/16/2021,Not Reported,Not Reported,,Not Reported,N,03/13/2021,03/16/2021,3.0,PHM,unknown,unknown,unknown,,unknown,"['Cardiac arrest', 'Death']",1,JANSSEN,IM 1103750,HI,92.0,F,"DAY AFTER, PT COMPLAINED OF PAIN IN LEFT COLLAR BONE. PATIENT DECLINED IN FUNCTION OVER NEXT 11 DAYS. HOSPICE WAS CONSULTED AND PT PASSED ON 2/23/21",Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/13/2021,1.0,PVT,UNKNOWN,HTN ECZEMA HYPOTHYROIDISM DIABETIC NEUROPATHY RESTLESS LEG SYNDROME,,,PENICILLIN,"['Bone pain', 'Death']",1,PFIZER\BIONTECH,IM 1103813,NY,67.0,F,"Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis.",Yes,03/13/2021,Not Reported,Yes,4.0,Not Reported,N,02/28/2021,03/02/2021,2.0,UNK,"Ibrance, vit d, femara, losartan, hctz","HTN, Mild COPD, Breast cancer",as above,,None,"['Abdominal distension', 'Acute kidney injury', 'Chest pain', 'Death', 'Dehydration', 'Dyspnoea', 'Echocardiogram normal', 'Electrocardiogram normal', 'Fatigue', 'Haemoglobin normal', 'Influenza virus test negative', 'International normalised ratio normal', 'Nausea', 'Pain', 'Platelet count normal', 'Prothrombin time normal', 'Renal failure', 'SARS-CoV-2 test negative', 'Ultrasound kidney normal', 'Urine analysis normal', 'Vomiting', 'White blood cell count normal']",1,MODERNA,IM 1103821,,86.0,M,Weakness Death,Yes,03/12/2021,Not Reported,Yes,,Not Reported,,01/20/2021,02/18/2021,29.0,PVT,,,,,,"['Asthenia', 'Death']",2,PFIZER\BIONTECH,IM 1103826,,87.0,M,"chest pain, acute heart failue death",Yes,03/12/2021,Not Reported,Yes,,Not Reported,,01/25/2021,03/06/2021,40.0,PVT,,,,,,"['Cardiac failure acute', 'Chest pain', 'Death']",2,MODERNA,IM 1103830,MI,61.0,F,"She also experienced shortness of breath/out of breath; heart out of sync; new heart rhythm abnormality; she has heart rhythm problem (premature atrial contraction); feeling exhausted; This is a spontaneous report from a contactable Nurse (patient). A 61 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249), via an unspecified route of administration on 19Jan2021 (at the age of 61 -years-old), single dose for COVID-19 immunization. Medical history included covid infection over a year ago. The patient had no concomitant medicines were not reported. The patient She had flare ups when she took Hep b vaccine before and did not get the 2 remaining doses because of the reaction. She has had so many vaccines over the years and had her flu shot every year. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 19Jan2021. Consulted the doctor 01Feb and told she has heart rhythm problem (premature atrial contraction). She also experienced shortness of breath. Not sure if it is vaccine related or due to her age. She will have the 2nd dose on 09Feb2021. Stated that she was feeling exhausted (29Jan2021) and out of breath. Stated that the doctor told her that her heart rhythm out of sync. Stated that in Dec she had her heart checked and it was okay. Stated that her other Covid is due to be given 09Feb. Does not know if the vaccine is contributing to her heart rate's bivalvular rhythm. Stated that she had Covid infection over a year ago. Stated that she is worried that the vaccine caused an abnormal rhythm to her heart. Stated that she has a new heart rhythm abnormality. Stated that she had all of her lab work done on 11Jan2021 and it was okay. Stated that on 27Jan-28Jan that she tried to pick up a watermelon and was short of breath for no reason. Stated that it happened a couple of times. Stated with her rhythm being out of sync that it feels like her heart is failing. The outcome of the event dyspnea was recovered, heart disorder and fatigue was not recovered, other events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported arrhythmia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/19/2021,01/29/2021,10.0,UNK,,,Medical History/Concurrent Conditions: COVID-19 (over a year ago),,,"['Arrhythmia', 'Cardiac disorder', 'Dyspnoea', 'Fatigue', 'Investigation', 'Supraventricular extrasystoles']",1,PFIZER\BIONTECH, 1103831,,96.0,F,death,Yes,03/15/2021,Not Reported,Not Reported,,Not Reported,,02/16/2021,03/15/2021,27.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1103837,,73.0,M,"shortness of breath, dizziness death",Yes,03/13/2021,Not Reported,Yes,,Not Reported,,02/19/2021,02/23/2021,4.0,PVT,,,,,,"['Death', 'Dizziness', 'Dyspnoea']",UNK,PFIZER\BIONTECH,IM 1103847,,84.0,M,weakness fever death,Yes,03/13/2021,Not Reported,Yes,,Not Reported,,02/06/2021,02/11/2021,5.0,PVT,,,,,,"['Asthenia', 'Death', 'Pyrexia']",2,PFIZER\BIONTECH,IM 1103876,,74.0,M,"shortness of breath, cough, nausea, diarrhea death",Yes,03/12/2021,Not Reported,Yes,,Not Reported,,01/30/2021,02/24/2021,25.0,PVT,,,,,,"['Cough', 'Death', 'Diarrhoea', 'Dyspnoea', 'Nausea']",1,MODERNA,IM 1103885,,85.0,F,death,Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,,01/27/2021,02/23/2021,27.0,PVT,,,,,,['Death'],2,MODERNA,IM 1103915,,,F,"throat was itchy; heart rate increased; lightheaded; Tongue does not feel normal; A spontaneous report was received from a female healthcare professional of an unknown age female patient, who received Moderna's COVID-19 Vaccine and experienced tongue does not feel normal, itchy throat, increased heart rate, and was lightheaded. The patient's medical history was not provided. Concomitant medications were not provided by the reporter. On 05 Jan 2021, The patient received his first of two planned doses of mRNA-1273 (Lot number not provided) intramuscularly in the for prophylaxis of COVID-19 infection. On 05 Jan 2021, the patient reported that she had experienced lightheadedness for four to five minutes, her tongue did not feel normal, had an itchy throat, and an increased heart rate post first dosage of the COVID-19 vaccine. The symptoms of tongue did not feel normal, an itchy throat, and an increased heart rate disappeared after 30-45 minutes that day. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The events of tongue does not feel normal, itchy throat, increased heart rate, and lightheaded had resolved on 05 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/05/2021,01/05/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history provided),,,"['Dizziness', 'Heart rate increased', 'Throat irritation', 'Tongue disorder']",1,MODERNA,OT 1103943,MA,70.0,F,unexplained death,Yes,03/09/2021,Not Reported,Not Reported,,Not Reported,N,02/25/2021,03/09/2021,12.0,PVT,silvastatin,slightly elevated cholesterol,slightly overweight,,"seasonal allergies, asthma",['Death'],1,MODERNA,IM 1103955,IL,64.0,F,No adverse reactions at the time of vaccine. Was admitted to hospital 5 days later with BLL pneumonia and passed away on 03/10/2021,Yes,03/10/2021,Not Reported,Yes,2.0,Not Reported,N,03/03/2021,03/08/2021,5.0,PUB,Unknown,Secondary malignant neoplasm of bone CAD Colostomy related to diverticulitis abscess Atrial fibrillation Chronic myelomonocytic leukemia not having reached remission PVD Mixed hyperlipidemia CKD stage 3 Panlobular emphysema Metastatic breast cancer,Panlobular emphysema CKD stage 3,,Unknown,"['Death', 'Pneumonia']",UNK,MODERNA,IM 1103970,WV,66.0,M,"Reported by EMS per report from wife that he was ""sick after shot"" and got worse during the night. Wife found him the following morning cold and pale, pulseless. Dispatch called at 719AM. Pt pronounced on the scene and taken to Funeral Home. Uncertain if Medical Exam is planned",Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,03/11/2021,03/11/2021,0.0,PUB,unknown,unknown,unknown,,no,"['Death', 'Illness', 'Pallor', 'Peripheral coldness', 'Pulse absent']",1,PFIZER\BIONTECH,IM 1103981,NJ,50.0,F,Pt c/o hypoglycemia. Healthcare provider indicated pt has been trending down ( in the 50's) with blood glucose over the past few days prior to receiving the vaccine. Mother of patient insists the hypoglycemia is from the vaccine.,Not Reported,,Not Reported,Yes,1.0,Not Reported,U,03/15/2021,03/16/2021,1.0,PVT,Information is unavailable,Pt is a known diabetic.,"Diabetes, Stroke. HTN, Hyperlipidemia, Neuropthy, Expressive Dysphagia",,NKA,"['Blood glucose decreased', 'Hypoglycaemia', 'Laboratory test']",1,JANSSEN,IM 1104031,FL,57.0,M,Patient died of cardiac arrest at hospital 3/12/2021,Yes,03/12/2021,Not Reported,Yes,2.0,Not Reported,N,03/01/2021,03/11/2021,10.0,WRK,"Albuterol, Tiotropium, Meloxicam, Budesonide, Mirtazapine, Nicotine Polarcriliex 4 MG, Nicotine","Chronic obstructive lung disease, bilateral nontraumatic rotator cuff rupture, major depressive disorder, alcohol dependence, tobacco use, mixed hyperlipidemia, elevated total bilirubin, SPL-Spondylolisthesis, low back pain, gout, Chronic obstructive lung disease, Sciatica, Pterygium",Chronic obstructive lung disease,,No known allergies,"['Cardiac arrest', 'Death']",2,PFIZER\BIONTECH,IM 1104059,CA,,F,"positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. A female patient in her seventies received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on 18Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient was tested for COVID-19 on 01Feb2021 and found out that she was positive on Wednesday. The reporter stated that she had relatives who received the first dose of the Pfizer-BioNtech Covid-19 vaccine and then they tested positive for Covid-19. They were scheduled for the second dose of the vaccine this week (""yesterday""). They were confused about when to get it or if they could get it. Their doctor said it was okay that they received the second dose of the vaccine, but the caller wanted to check with Pfizer the recommendations on this topic. She stated that she had heard ""all kinds of crazy information"", she heard that if someone had a cough and received the second dose of the vaccine, the cough would become more severe. She would like to know if this was true and if it was better to wait for the second dose of the vaccine. She also wanted to know what the longest period was someone could wait to receive the second dose of the Pfizer-BioNtech Covid-19 vaccine after the 21-day period. The clinical outcome of the event positive COVID-19 test was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021140470 Same reporter/drug/AE and different patients.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/18/2021,02/01/2021,14.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1104060,CA,79.0,M,"positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable consumer who reported for his father. A 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on 21Jan2021 (also reported as 24Jan2021) (at the age of 79-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient received the first dose of the Pfizer COVID-19 vaccine and had since tested positive. The reporter stated that his dad got the vaccine on 21Jan2021 and got COVID-19 but got the first dose only. The patient had recovered and was coming back from the hospital, he was not critical. The patient was scheduled to get his second vaccine on 11Feb2021 but was getting over treatment. The reporter inquired whether the patient could get the second dose. He stated that he had heard that he had to wait 90 days after COVID and asked whether he should get the second vaccine now. The clinical outcome of the event positive COVID-19 test was recovered/resolved on an unspecified date. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/21/2021,,,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1104080,,73.0,F,death,Yes,03/15/2021,Not Reported,Yes,,Not Reported,,02/06/2021,03/12/2021,34.0,PVT,,,,,,['Death'],2,PFIZER\BIONTECH,IM 1104175,MD,35.0,F,"She received the 2nd Dose on 3/9/2021. On 3/10/2021 She complained of a headache. On the morning of 3/11/2021 she complained of abdominal pain and had no appetite. We then found her unresponsive, called 911 and the medics pronounced her at around 1300.",Yes,03/11/2021,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/11/2021,2.0,OTH,"Norethindrone .35MG Daily - Birth Control 10 MG Zyrtec Allergy Daily - Allergies 5000 mcg Biotin Gummy Daily - Hari, Skin & Nails Vitamin 50 mcg D3 Gummy Daily - Bone & Immune System Vitamin 45 mg Iron plus Vitamin C Soft Chew Daily - Vitam",None,Myotonic Dystrophy DM 1 - Congenital : characterized by progressive muscle wasting and weakness. Physical and Intellectual Disability,,None to Date,"['Abdominal pain', 'Death', 'Decreased appetite', 'Headache', 'Unresponsive to stimuli']",2,PFIZER\BIONTECH, 1104177,WA,76.0,F,"first vaccine (Moderna) was injected on 02/03/2021, second vaccine (pfizer) was injected on 03/02/2021, my Mother was dead on 03/08/2021. with no symptoms on 03/07/2021.",Yes,03/08/2021,Not Reported,Not Reported,,Not Reported,N,02/03/2021,03/08/2021,33.0,PVT,,dead on 03/08/2021,none,,none,"['Autopsy', 'Death']",2,MODERNA,SYR 1104252,,84.0,M,"Death Narrative: On 2/12/21, patient was hospitalized at Medical Center with ""leaking and swollen legs."" Patient was transferred to hospital 2/13/21 for a vascular surgeon consult, where patient was diagnosed with lower extremity ischemia and acute diastolic heart failure. A bilateral, common endarterectomy with bovine angioplasty and bilateral iliac stent placement was performed on 2/17/21. Patient was discharged to a skilled nursing facility on 2/26/21. Patient had received first covid vaccination on 1/29/21. He was due to receive his second dose on 2/26/21, however, the appointment was moved to 3/10/21 since patient was hospitalized. Patient received his second dose on 3/10/21. Patient was hospitalized again (reason for hospitalization unknown) where he passed away 3/11/21 at hospital.",Yes,03/11/2021,Not Reported,Not Reported,,Not Reported,N,03/10/2021,03/11/2021,1.0,OTH,,,,,,"['Acute left ventricular failure', 'Angioplasty', 'Coronary arterial stent insertion', 'Death', 'Endarterectomy', 'Peripheral ischaemia', 'Peripheral swelling', 'Skin weeping', 'Stent placement']",UNK,MODERNA,IM 1104254,NY,,M,"transient ischemic attack episode; A spontaneous report was received from a Physician concerning a 71 year old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced transient ischemic attack episode. The patient's medical history and products known to have been used by the patient were not reported. The patient received the first of two planned doses of mRNA-1273 (Batch number: 029L20A) on 25 Jan 2021, approximately four days prior to the onset of the symptoms intramuscularly for prophylaxis of COVID-19 infection. On 28 Jan 2021 the patient experienced transient ischemic attack episode and was hospitalized for 24 hours and then was discharged. No treatment information was provided. No relevant laboratory details were included. Action taken with the drug in response to the events were not reported. The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,01/25/2021,01/28/2021,3.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history was reported.),,,['Transient ischaemic attack'],1,MODERNA,OT 1104257,,68.0,M,Death Narrative: 1st Dose of COVID Vaccination,Yes,03/07/2021,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/07/2021,3.0,OTH,,,,,,['Death'],1,MODERNA,IM 1104258,,80.0,M,"Deceased Narrative: Patient was a 79 yr old male with a PMH of metastatic rectal cancer with colostomy s/p chemo with RT in 2015-16 with recurrence in 2020, was on holiday from palliative chemo since 9/23/20 due to chemo-related toxicity. Patient was admitted back to Facility on 10/08 for RLE pain ins/o increased weakness and functional decline. Patient decided to transition to hospice care and was admitted to Facility 10/13 for end life care, where he continuously showed signs of functional decline.",Yes,03/09/2021,Not Reported,Not Reported,,Not Reported,N,01/03/2021,03/09/2021,65.0,OTH,,,,,,['Death'],2,PFIZER\BIONTECH,IM 1104337,AZ,85.0,F,On 3/23 at 0730 resdient non responsive with saliva foaming from mouth. BS 500. All vitals initially Ok then sats dropped to 75. (11 was called immediately upon finding resident. Taken to hospital. Completed course there and later on to rehab. She expired 3/11/2021,Yes,03/11/2021,Not Reported,Yes,1.0,Not Reported,N,02/22/2021,02/23/2021,1.0,SEN,ASA Lisinopril metoprolol risperidone potassium,"Diabetes, HTN","Dementia,, CKD. CHF",,NKDA,"['Blood glucose increased', 'Death', 'Foaming at mouth', 'Oxygen saturation decreased', 'Unresponsive to stimuli']",2,MODERNA,IM 1104364,NY,73.0,M,Death within 24 hours of receiving vaccine,Yes,03/10/2021,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/10/2021,1.0,PVT,Amlodipine 10 mg daily Hydrochlorothiazide 25 mg daily Lisinopril 40 mg daily,None,Hypertension Gout,,Penicillin,['Death'],1,MODERNA,IM 1104384,FL,69.0,F,"Being in the Mall, accompanied by her cousin, felt a severe headache and pain in both shoulders followed immediately by fainting, cardio-respiratory arrest that required call 911 for emergency transfer to Hospital. She was intubated in the emergency room treated by the doctors, Cardiologist and Intensive care where she was subjected to hypothermia and other treatments due to the serious neurological damage that she presented. No other organ seemed compromised. Never came out of the coma, passing away on February 26, 2021.",Yes,02/28/2021,Not Reported,Yes,12.0,Not Reported,N,02/13/2021,02/16/2021,3.0,PVT,Lisinopril 20 mg,None,None,,None,"['Arthralgia', 'Brain injury', 'Cardio-respiratory arrest', 'Coma', 'Computerised tomogram head abnormal', 'Death', 'Endotracheal intubation', 'Headache', 'Hypothermia', 'Intensive care', 'Laboratory test', 'Magnetic resonance imaging head abnormal', 'Nervous system disorder', 'Syncope']",1,PFIZER\BIONTECH,IM 1104428,,95.0,M,"Deceased Narrative: Patient was outpatient, there is no information about reactions, underlying or active conditions between the time they came in for their first Pfizer dose and their death.",Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/22/2021,23.0,OTH,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1104429,,70.0,M,"Death Narrative: Patient with medical history significant for malnutrition and end stage COPD. Patient was on 5 to 6 liters/min of oxygen. On 3/10/21, patient received his first COVID-19 vaccination. On 3/12/21, patient was admitted to Hospice for home hospice care due to worsening of COPD. Per medical examiner, patient passed away on 3/13/21.",Yes,03/13/2021,Not Reported,Not Reported,,Not Reported,N,03/10/2021,03/13/2021,3.0,OTH,,,,,,"['Chronic obstructive pulmonary disease', 'Condition aggravated', 'Death']",UNK,MODERNA,IM 1104430,,98.0,M,Death Narrative: Patient has been admitted to a home hospice program since approximately 11/12/20 with an initial terminal diagnosis of dysphagia which was later changed in February 2021 to vascular dementia. Patient with significant past medical history of several CVA's which led to aphasia and vascular dementia.,Yes,03/13/2021,Not Reported,Not Reported,,Not Reported,N,03/12/2021,03/13/2021,1.0,OTH,,,,,,['Death'],UNK,JANSSEN,IM 1104666,GA,79.0,F,Patient presented with dyspnea and found to have COVID 19 infection. Treated with steroids and oxygen but clinically deteriorated and died,Yes,03/16/2021,Not Reported,Yes,11.0,Not Reported,N,01/14/2021,03/05/2021,50.0,PVT,,,Heart failure Diabetes,,,"['COVID-19', 'Death', 'Dyspnoea', 'General physical health deterioration', 'SARS-CoV-2 antibody test negative', 'SARS-CoV-2 test positive']",1,PFIZER\BIONTECH,IM 1104671,MI,39.0,M,"Patient has a long history of seizures. He has seizures on a daily basis. He lives with his family, who are his primary caregivers, they family provides all of his activities of daily living. Patient received vaccine on Friday morning, feeling well throughout the day according to the father. Went to bed, during the night in bed he had seizures which is typical for him, and during the episode the father noticed that he had stopped breathing. called 911 who came to the house and the patient died in the house. I do not believe he went to the hospital.",Yes,03/13/2021,Not Reported,Not Reported,,Not Reported,N,03/12/2021,03/13/2021,1.0,PVT,"CoQ-10 200 mg twice a day, diazepam 10mg one as needed for seizures, Dilantin Infatabs 50mg 1 tab every morning. lamictal 150mg 2 tabs twice a day, midodrine 2.5mg 1 tab twice a day, vitamin D3 400IU daily.","Seizure disorder, severe mitochondrial myopathy, gastroesophageal reflux disease","Seizure disorder, severe mitochondrial myopathy",,"IV lactated ringers, midazolam, morphine, vancomycin","['Condition aggravated', 'Death', 'Malaise', 'Respiratory arrest', 'Seizure']",1,JANSSEN,IM 1104698,,66.0,F,RESPIRATORY DISTRESS Death,Yes,03/15/2021,Not Reported,Yes,,Not Reported,,02/03/2021,03/03/2021,28.0,PVT,,,,,,"['Death', 'Respiratory distress']",2,PFIZER\BIONTECH,IM 1104699,KS,85.0,M,Patient had been admitted to hospice care on 11/3/20. He reportedly declined in health and died 2/12/21.,Yes,02/12/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/06/2021,1.0,PUB,Guaifenesin Lorazepam Morphine Ipratropium-Albuterol Venlafaxine Phenazopyridine Amoxicillin Divalproex Sodium Albuterol Omeprazole Furosemide Meloxicam Donepezil Budesonide-Formoterol Memantine,Pneumonia 1/15/21,COPD Alzheimer's Disease Chronic Respiratory Failure,,Quinolone (oral),"['Death', 'General physical health deterioration']",1,MODERNA,IM 1104720,,65.0,M,death,Yes,03/11/2021,Not Reported,Not Reported,,Not Reported,,02/20/2021,03/11/2021,19.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1104764,MD,54.0,F,"Patient with known history of ITP status post splenectomy in 2018, with stable platelet counts off treatment, developed petecchial rash in lower extremities 2 days after receiving COVID vaccine during a mass vaccination campaign. Platelet counts check 2 days after the vaccination was 1,000. Patient was admitted to the hospital for ITP, received 2 doses of IVIG and was initiated on prednisone with improvement in platelet count to 72,000 by 03/14/2021. Give",Not Reported,,Not Reported,Yes,2.0,Not Reported,Y,03/10/2021,03/12/2021,2.0,OTH,Vit D Calcium MVI Escitalopram Levothyroxine,UTI,ITP,,None,"['Condition aggravated', 'Immune thrombocytopenia', 'Immunoglobulin therapy', 'Petechiae', 'Platelet count decreased', 'Rash']",1,JANSSEN,IM 1104806,WI,80.0,M,Patient received the COVID-19 vaccine and expired the next day.,Yes,03/09/2021,Not Reported,Not Reported,,Not Reported,,03/08/2021,03/09/2021,1.0,UNK,"acetaminophen, abuterol, amiodarone, alodipine besylate, 81 mg aspirin, atorvastatin, budesonide, bumetanide, Vitamins D, B, and C, docusate, duloxetine, lidocaine, oxymetazone, pantoprazole, potassium chloride, rivaroxaban, tamsulosin, dic","congestive heart failure, diabetes, renal failure, coronary artery disease","congestive heart failure, diabetes, renal failure, coronary artery disease",,,['Death'],UNK,UNKNOWN MANUFACTURER, 1104815,TX,73.0,M,Seen in ED for positive COVID symptoms - discharged with instructions. Death 1/26/2021,Yes,01/26/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,01/22/2021,7.0,UNK,,,,,,"['COVID-19', 'Death']",1,MODERNA,UN 1104845,NC,60.0,M,Deceased received second Moderna dose on 3/11/2021 at unknown location and unknown time. Complained of 'side effects' which are unclear at this time. Had a sudden witnessed cardiac event on 3/14/2021 and was rushed to a local emergency department. Diagnosed with ST elevation MI and could not be fully resuscitated.,Yes,03/14/2021,Not Reported,Not Reported,,Not Reported,N,03/11/2021,03/11/2021,0.0,UNK,,,"Gastroesophageal reflux disease, Chronic back pain",,,"['Acute myocardial infarction', 'Amphetamines positive', 'Arteriosclerosis', 'Autopsy', 'Cardiac disorder', 'Death', 'Drug screen positive', 'Vaccination complication']",2,MODERNA, 1105115,PR,18.0,M,"Resident did not express having any symptoms, the only thing that the POC observed abscesses in the arm, groin, thigh and knees after the first vaccination. After the second dose, he was hypoactive. On 2/27 at about 3:30 am he asked him to turn on his side, between 4 am and 5 am POC went to the room I notice it strange, because his head was wrapped in the sheet. When the POC removed the sheet, she observed that her mouth and nose were full of secretions. So he turned it and he himself did not react. He called the emergency who certifies that he had no vital signs. (emergency arrives within 5:45 am to 6:00 am)",Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/18/2021,4.0,SEN,"Keppra 1000 mg, Lamictal , Vimpat, Quetiapina, Lorazepam, Zyprexa, Motrin, Vitamina K, Acido Folico, Sultato Ferroso, Multivitam�nico 365",None,"Portal hypertension (secondary to portal vein thrombosis), Leukopenia, Thrombocytopenia, Epilepsy, Splenomegaly, Esophageal Varices, Asthma, Pancytopenia and Severe mental retardation.",,Dilantin and aspirin,"['Abscess limb', 'Death', 'Decreased activity', 'Groin abscess', 'Increased upper airway secretion']",2,MODERNA,IM 1105125,MA,79.0,F,Patient had a hemorrhagic stroke,Yes,03/10/2021,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/10/2021,2.0,PHM,Apixaban Levothyroxine Sodium Pravastatin Sodium Metoprolol Succinate Lorazapam Folic Acid Feosol Natural Release,Elevated blood pressure,"Hypothyroid ? Paroxysmal atrial fibrillation (HCC) ? S/p TAVR (transcatheter aortic valve replacement), bioprosthetic ? Iron deficiency anemia ? Epistaxis ? Hyperlipidemia ? Hypercoagulable state due to atrial fibrillation (HCC)",,Amlodipine Lisinopril,['Haemorrhagic stroke'],2,MODERNA,IM 1105146,PR,23.0,M,"1/19 began vomiting and was hospitalized. On 1/30 he was discharged and later received the vaccine. It begins with weakness and a lack of appetite. He started coughing up foul-smelling secretions. He makes the arrangements to take him to the emergency room again, he called 911 to be transported, when they are taking the information from the POC, he is under oxygenation to 44. They take him in the ambulance, he receives CPR, they transport him to the facility where he arrives lifeless.",Yes,02/02/2021,Not Reported,Not Reported,,Not Reported,N,01/30/2021,01/30/2021,0.0,SEN,"Keppra 1000 mg, Flexeril, Vitamins",None,"Epilepsy, Hydrocephalus, and Multiple Sclerosis",,Not reported,"['Asthenia', 'Death', 'Decreased appetite', 'Productive cough', 'Resuscitation', 'Vomiting']",1,MODERNA,IM 1105193,IA,83.0,M,Death due to pulmonary fibrosis,Yes,03/14/2021,Not Reported,Not Reported,,Not Reported,N,03/12/2021,03/14/2021,2.0,PVT,"acetaminophen, benzonatate, clopidogrel, cyclobenzaprine, docusate-senna prn, doxylamine, escitalopram, fluticasone topical, furosemide, hydrocortisone topical, latanoprost ophthalmic, levothyroxine, metformin, midodrine, nitroglycerin prn,",Patient was hospitalized from 1/31- 2/4 with SARS- COVID-19 pneumonia.,"chronic hypoxemic respiratory failure, pulmonary fibrosis, coronary artery disease, diastolic heart failure, ALS, type 2 diabetes, obesity, hypothyroidism, BPH, anemia, degenerative lumbar disc disease, diverticulosis, gout, hyperlipidemia, ocular hypertension, orthostatic hypotension, sleep apnea",,"celebrex, penicillin, sulfa drugs, tramadol","['Death', 'Pulmonary fibrosis']",1,PFIZER\BIONTECH,IM 1105261,PR,85.0,F,The patient was admitted to hospice because she stopped eating and deteriorated. He was being given food through the tube and then he has no vital signs.,Yes,02/22/2021,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/22/2021,23.0,SEN,"Megace, Lorazepam 2 times a day, Tentral 400mg 2 times a day,, Quetiapine 100mg 2 times a day, Pepcid 20mg, Fluoxetine, Atorvastatin 20 MG, Temazepam 20 mg",None,"ALZHEIMER, CIRCULATION PROBLEMS, POOR APPETITE, HYPERTENSION, ARTHRITIS, DEPRESSION",,Not reported,"['Death', 'Feeding tube user', 'General physical health deterioration', 'Hypophagia']",1,MODERNA,IM 1105300,PR,88.0,F,"He went to the hospital for cardiovascular problems and cholecystitis and was under treatment after the first dose. 2/26/2021 at around 11:00 pm she was complaining of high blood pressure, uncontrolled vital signs, uncontrolled sugar, at 6:00 am she has passed away. They certify respiratory failure.",Yes,02/27/2021,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/27/2021,9.0,SEN,"Quetapil 50 MG, Deforming, Metropol, Simvastatina Sereoquel, Trazodone 50 MG",None,"Hypertension, DIABETES, CHOLESTEROL, Arrhythmia, ALZHEIMER",,Not reported,"['Blood glucose abnormal', 'Cardiovascular disorder', 'Cholecystitis', 'Death', 'Hypertension', 'Respiratory failure']",2,MODERNA,IM 1105408,CT,93.0,M,Death,Yes,03/09/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,03/09/2021,36.0,PVT,,,,,,['Death'],UNK,MODERNA, 1105600,TX,99.0,M,"Death on Feb 14, 2021",Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,N,01/11/2021,02/14/2021,34.0,SEN,Carvedilol 3.125 mg: � of 6.25mg twice a day Metformin 500 mg: 1 tablet twice a day Multivitamin: 1 tablet TruNature Vision Complex Lutein and Zeaxanthin 25mg / 5 mg: 1 tablet Glucosamine / Chondroitin: 1 tablet twice a day Aspiri,,"Cardiac disease, osteoarthritis, Fuch's dystrophy, aspiration of liquids",Tetanus shot sometime when patient was in his 30s. This was when it was discovered that he was allergic to tetanus / typhoid sh,"Tetanus vaccine and toxoid, horse serum, ace inhibitors, Avelox (Moxifloxacin)",['Death'],UNK,PFIZER\BIONTECH,SYR 1105679,CA,74.0,M,"My father complained of heartburn the evening he received his vaccine. He told my mother he need to sit down and relax. My mother walked into the other room to watch some TV while she allowed my dad to relax. During that time, my mother fell asleep. She woke up after an hour when she realized my dad was not sitting next to her. She went to the living room where he was sitting and discovered he was not breathing and passed away. EMT was called and they said they could not do anything for my dad since he was already gone.",Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/09/2021,0.0,PVT,"Insulin for T2 Diabetes, Omepreozole for heartburn.",None.,T2 Diabeties Heartburn - 6 months Knee problems,,None,"['Condition aggravated', 'Death', 'Dyspepsia', 'Respiratory arrest']",1,PFIZER\BIONTECH,IM 1105749,CA,74.0,M,Patient died on 2/28/2021,Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,01/29/2021,02/28/2021,30.0,OTH,"Ceftazidime 1500mg IP every day Vancomycin 1500mg IP twice weekly Diflucan 100mg PO every day Epogen SQ 16,000 units weekly Icodextrin 2500mL IP daily Nepro PO daily Potassium Chloride 20mEq PO daily ASA 81mg PO every day Atorvastatin Calc",Peritonitis (MRSA),CHF Diabetes Type 2 Insulin dependent ESRD,,Heparin,['Death'],1,MODERNA,IM 1105772,MA,93.0,F,"My mother died on February 19, 2021. She had her 2nd dose vaccine on 2/11, on 2/12 it was noted that she was not able to walk, on 2/13 she was walking at 30%, on 2/14 she was walking with difficulty, on Monday 2/15 she was throwing up violently and her blood pressure dropped, so she was sent to Clinic. My sister was told she was just constipated and she had A Fib (never reported before to us). My sister was then told on 2/16 early a.m. that she had a blood clot that destroyed her colon. Due to age surgery would likely not be successful. She then died on the Friday. We are reporting in the event that the Pfizer vaccine was somehow a contributing factor to the A fib or to the Clot. She has no history of A fib or clotting prior to this incident. She was 93, and did have dementia, but was able to eat normal foods prior to this. What was unusual was the challenge in walking the day after the shot. Other than that no difference was observed until the day she was admitted to the hospital emergency room. She was a resident at Assisted Living, Memory Care, and that is where she received the vaccine. The mailing address I provided is her mailing address prior to death.",Yes,02/19/2021,Not Reported,Yes,5.0,Not Reported,N,02/11/2021,02/12/2021,1.0,PVT,"Vitamin D, Docusate Softgel, Amlodipine, Trazodone, Multivitamin, Clonidine, Sea, Lisinopril, Citalopram, Acetamin, Pantoprazole, Santyl Ointment, Calcium Antacid Chew, Olanzapine","Dementia with associated mental illness, and high blood pressure. Bed sore on foot.","Dementia with associated mental illness, high blood pressure, recovery from broken hip",,None known,"['Atrial fibrillation', 'Blood pressure decreased', 'Constipation', 'Death', 'Gait disturbance', 'Gait inability', 'Thrombosis', 'Vomiting']",2,PFIZER\BIONTECH,IM 1105817,AZ,60.0,M,Bells Palsey symptoms have returned. Right side of my face twitching and drooping,Not Reported,,Not Reported,Not Reported,,Yes,N,03/09/2021,03/13/2021,4.0,SCH,None,None,Bells Palsey in remission,,Penicillin,"[""Bell's palsy"", 'Condition aggravated', 'Facial paralysis', 'Muscle twitching']",1,JANSSEN,SYR 1105820,WI,89.0,F,"Patient seen and evaluated by PA-C. with myself. We agreed on the clinical findings and implemented our plan together. Please see PA's note for details. All relevant procedures supervised. Patient arrived to the emergency department due to respiratory symptoms, hypoxic, reported that Wednesday he received his 2nd dose of COVID vaccine. His initial workup was concern for NSTEMI with elevated troponin and peaked T-waves, his chest x-ray concerning for COVID/pneumonia. Patient initially tolerated oxygen by nasal cannula and sepsis protocol was started including IV fluid resuscitation that was done cautiously due to the concern of COVID with respiratory failure. The biotics were given. PA-C readdressed code status with patient who confirmed that his DNR DNI, she so contacted his daughter. Patient had multiorgan failure including acute kidney injury, and pneumonia with respiratory failure +/- respiratory failure. Due to the concern of NSTEMI patient was initially going to be transfer to was hospital and transfer was started. Patient respiratory status started deteriorating and his blood pressure dropped slightly but improved after 500 cubic centimeters of IV fluid and he was also placed on a NIPPV. Around 6:00 p.m. patient has significantly desaturation and he discontinued himself NIPPV. Due to inability to intubate patient, he was ventilated with BVM, patient is slowly improved saturation levels and was opening his eyes, he was placed on a non-rebreather. At this point there is high concern of ARDS and due to inability to intubate or give for the respiratory support His daughter was at bedside and updated of current medical status and poor prognosis. Patient continued deteriorating and at this point he had agonal breathing. His daughter was at bedside and she was made aware of the futile prognosis of patient due to his respiratory failure. Patient rapidly became bradycardic and went into cardiac arrest. No CPR was done due to the DNI DNR status of the patient. � Critical Care Procedure Note Authorized and Performed by: MD Total critical care time: Approximately 30 minutes Due to a high probability of clinically significant, life threatening deterioration, the patient required my highest level of preparedness to intervene emergently and I personally spent this critical care time directly and personally managing the patient. This critical care time included obtaining a history; examining the patient; pulse oximetry; ordering and review of studies; arranging urgent treatment with development of a management plan; evaluation of patient's response to treatment; frequent reassessment; and, discussions with other providers. This critical care time was performed to assess and manage the high probability of imminent, life-threatening deterioration that could result in multi-organ failure. It was exclusive of separately billable procedures and treating other patients and teaching time. Please see MDM section and the rest of the note for further information on patient assessment and treatment. � PE: VITAL SIGNS: BP: 126/75 Pulse: (!) 122 Resp: (!) 40 SpO2: (!) 82 % Temp: 98.1 �F (36.7 �C) Height: 5' 8"" (172.7 cm) Weight: 152 lb (68.9 kg) General: Alert, nontoxic, in no acute distress. Lungs: Clear to auscultation bilaterally. � CLINICAL IMPRESSION: 1. Sepsis with acute hypoxic respiratory failure and septic shock, due to unspecified organism (HCC) 2. Suspected COVID-19 virus infection 3. NSTEMI (non-ST elevated myocardial infarction) (HCC) 4. Multifocal pneumonia 5. ARDS (adult respiratory distress syndrome) (HCC) 6. Acute kidney injury (HCC) � � Further care and disposition otherwise as outlined by PA. � � ED on 2/14/2021 Revision & Routing History Detailed Report Note filed date Mon Feb 15, 2021 �8:46 AM",Yes,02/14/2021,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/14/2021,2.0,PVT,"Rivaroxaban 15 and 20 MG, Tylenol, Meclizine 25 MG; Aspirin 18 MG daily, Pravastatin 20 MG daily, Multivitamins, BP formulation, Norvasc 5mg tablet daily . atenolol 25MG tablet daily",none,"Abdominal Aortic Anuerysm, Atypical chest pain, Benign essential Hypertension, Pure hypercholesterolemia",,none,"['Acute kidney injury', 'Acute myocardial infarction', 'Acute respiratory distress syndrome', 'Acute respiratory failure', 'Agonal respiration', 'Alanine aminotransferase normal', 'Albumin globulin ratio normal', 'Anion gap', 'Aspartate aminotransferase normal', 'Base excess negative', 'Basophil count decreased', 'Basophil percentage', 'Blood albumin decreased', 'Blood alkaline phosphatase normal', 'Blood bicarbonate decreased', 'Blood bilirubin normal', 'Blood calcium decreased', 'Blood chloride normal', 'Blood creatinine increased', 'Blood culture', 'Blood electrolytes normal', 'Blood glucose increased', 'Blood lactic acid increased', 'Blood pH increased', 'Blood potassium normal', 'Blood pressure decreased', 'Blood sodium decreased', 'Blood urea increased', 'Bradycardia', 'C-reactive protein increased', 'Carbon dioxide decreased', 'Cardiac arrest', 'Chest X-ray abnormal', 'Continuous positive airway pressure', 'Cyanosis', 'Death', 'Differential white blood cell count abnormal', 'Dyspnoea', 'Echocardiogram', 'Electrocardiogram QT prolonged', 'Electrocardiogram T wave peaked', 'Electrocardiogram abnormal', 'Eosinophil count normal', 'Eosinophil percentage', 'Fibrin D dimer increased', 'Full blood count abnormal', 'General physical health deterioration', 'Globulin', 'Glomerular filtration rate decreased', 'Haematocrit decreased', 'Haemoglobin decreased', 'Haemoptysis', 'Leukocytosis', 'Lung infiltration', 'Lymphocyte count decreased', 'Lymphocyte percentage decreased', 'Mean cell haemoglobin concentration normal', 'Mean cell haemoglobin increased', 'Mean cell volume increased', 'Mean platelet volume', 'Mean platelet volume normal', 'Mechanical ventilation', 'Metabolic acidosis', 'Monocyte count', 'Monocyte percentage', 'Multiple organ dysfunction syndrome', 'Myocardial ischaemia', 'Neutrophil count increased', 'Neutrophil percentage increased', 'Oxygen saturation decreased', 'PCO2 decreased', 'PO2 decreased', 'Platelet count decreased', 'Pneumonia', 'Procalcitonin increased', 'Protein total normal', 'Pulse absent', 'Red cell distribution width normal', 'Respiratory alkalosis', 'Respiratory symptom', 'SARS-CoV-2 test', 'SARS-CoV-2 test negative', 'Sepsis', 'Septic shock', 'Suspected COVID-19', 'Tachypnoea', 'Troponin T increased', 'Troponin increased', 'Venipuncture', 'White blood cell count']",2,MODERNA,IM 1106158,,,M,"Fever of 103-104; Really weak/Not wanting to do anything; Sleeping; hands started to shake visibly; really cold; Vomited; Chills so bad he put on pajamas; Incoherent; This spontaneous report was received from a consumer on 14FEB2021 regarding a 75-year-old, male patient who received the Moderna COVID-19 (mRNA-1273) vaccine and was experienced high fever, chills, shaking, vomiting, becoming really cold and incoherent. The patient's medical history provided was reported as chronic heart disease, hypertension, high cholesterol, COPD, Shortness of breath, and confirmed COVID-19 positive test in July of 2020. Concomitant medications were reported as Symbicort two puffs twice a day, albuterol nebulizer a couple times of day and home oxygen at night. On 12FEB2021, prior to the onset of the symptoms, the patient received the first of two planned doses of Moderna COVID-19 (mRNA-1273) Vaccine intramuscularly (Lot number: 024M20a). On 13FEB2021 upon returning from being out, around 1500 his hands started to shake visibly, started moaning, had the chills so bad he put on pajamas, was really cold, vomited, and became incoherent. About 1700 she called 911 because she did not think she could get him in the car. She could tell on his forehead he had a high fever. The paramedics came and took him to the emergency. At some point while in the emergency room, he was transferred to the ICU. Caller says this was probably because of the high fever of 103-104. The nurse told caller they could not get his fever to come down and packed him in ice. The doctor at the hospital contacted the caller to verify his DNR order. The nurse reported to the caller he did vomit again in the hospital. His fever came down on 14feb2021, stayed that night and was released to home on 15feb2021 at about 1330. All vitals were normal. He was not released with medications but told he can use his normal oxygen he uses at night during the day if needed. On 16feb2021 he is really weak, sleeping, not wanting to do anything. Caller says she is not sure if that is from the vaccine or the hospital stay. He told her he got little sleep since they were in and out of his hospital room all night. He has a follow up appointment with his primary care physician on 18feb2021. His second dose is scheduled for 12mar2021. Caller states he is on a list of medications and also has chronic heart disease, hypertension, high cholesterol and COPD that has worsened since July. He takes Symbicort two puffs twice a day, is on albuterol nebulizer a couple times of day. He does have more shortness of breath but that has been since July. He does not have a past experience of the mentioned side effects from other medications or vaccines. No further information was obtained. Caller provides consent for safety to contact"". The action taken for Moderna COVID-19 (mRNA-1273) Vaccine was not provided.. The outcome of the events, ""sleepy and really weak, not wanting to do anything"" was not reported. The outcome of the events, ""Fever 103-104, hands started to shake visibly, moaning, chills so bad he put on pajamas, really cold, vomited, incoherent, really weak, sleeping, not wanting to do anything, ""was reported as resolved on 15FEB2021.; Reporter's Comments: This case concerns a 75 year old, male patient, with history of drug allergies and CHD, HT, high cholesterol, COPD, and COVID-19 positive (July 2021), who experienced a serious unexpected event of pyrexia among others, 2 day after receiving 1st dose of mRNA- 1273 (Lot# 024M20a). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Yes,3.0,Not Reported,Y,02/12/2021,02/13/2021,1.0,UNK,ALBUTEROL HFA; SYMBICORT,"COPD; Drug allergy (allergies to Cipro); Heart disease, unspecified; High cholesterol; Hypertension","Medical History/Concurrent Conditions: COVID-19 (previously had Covid in July 2020 and was hospitalized for 3 nights, no vent was needed.); Drug allergy (Allergy to Quinine); Drug allergy (Allergy to Flagyl)",,,"['Asthenia', 'Chills', 'Feeling cold', 'Incoherent', 'Pyrexia', 'Somnolence', 'Tremor', 'Vomiting']",1,MODERNA,OT 1106162,AL,,F,"Mycoplasma pneumoniae pneumonia; Chills; Violently sick; labored breathing; Oxygen saturation low; vaccination site pain; immunodeficiency; A spontaneous report was received from a consumer concerning a 79-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced mycoplasma pneumoniae pneumonia, chills, illness, labored breathing, vaccination site pain, immunodeficiency, and oxygen level saturated. The patient's medical history included congestive heart failure, pulmonary disease, immune system disorder history of 22 stents placed in her heart, peripheral artery disease, coronary artery disease, regurgitating food and covid-19 test. No relevant concomitant medications were reported. On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 15 Feb 2021, approximately 1day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, she developed chills and became violently sick. Her oxygen was 94 at home but dropped into the 80s at the facility. She has had to have 40-50% oxygen. At first, they thought she might have aspiration pneumonia because she has had problems keeping food down and regurgitating in the past. They did tests and told us she has Mycoplasma pneumonia. The doctor said if she had a normal immune system, she could just take something over the counter, but not with her because her immune system is low. They did four COVID tests because they thought she might have had a false negative, but all of them have been negative. So, at least we know she doesn't have COVID. Her oxygen has been in the 90s, but she still says she is having a hard time breathing and it is labored. She continues to be in intensive care. Treatment for the event included oxygen . The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable. The outcome of the events mycoplasma pneumoniae pneumonia, chills, illness, labored breathing, vaccination site pain, immunodeficiency, and oxygen level saturated were unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events (chills and vaccination site pain) and the administration of the mRNA-1273 cannot be excluded. However, the event of Mycoplasma pneumonia is Unlikely related to mRNA-1273. The events- illness, dyspnoea, oxygen saturation decreased could be due to mycoplasma pneumonia. However, the subject's history of weak immune system may remain as a risk factor.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/11/2021,02/16/2021,36.0,UNK,,,Medical History/Concurrent Conditions: Congestive heart failure; Coronary artery disease; COVID-19 virus test; Immune imbalance; Immune system disorder; Peripheral arterial disease; Pulmonary disorder; Rumination disorder; Stent insertion NOS (22 stents placed in her heart),,,"['COVID-19', 'Chills', 'Dyspnoea', 'Illness', 'Immunodeficiency', 'Mycoplasma test positive', 'Oxygen consumption', 'Oxygen saturation decreased', 'Pneumonia mycoplasmal', 'Vaccination site pain']",1,MODERNA,OT 1106164,,,F,"delirious; arm pain; developed a temperature of 103; vomiting; Chills; A spontaneous report was received from a health care professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm pain ,vomiting, chills,fever 103'F and was delirious. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Jan 2021 , prior to the onset of the events the patient received his first of two planned doses of mRNA-1273 (lot/batch:unknown ) via unknown route of administration and unknown anatomical location for prophylaxis of COVID-19 infection. On 23 Jan 2021. the patient experienced significant arm pain and as the night went on began vomiting, chills and developed a temperature of 103 and was delirious at the point where he was taken to emergency room. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events significant arm pain, vomiting, chills, fever and delirium was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/22/2021,01/22/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Body temperature', 'Chills', 'Delirium', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,MODERNA, 1106165,GA,,F,"Diverticulitis; A spontaneous report was received from a consumer concerning a unspecified age, female patient who received Moderna's COVID-19 vaccine and was hospitalized for diverticulitis. The patient's medical history was diverticulitis. Concomitant product use was not provided by the reporter. On 28 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. The patient experienced diverticulitis (preexisting condition) since an unknown date due to which the patient was hospitalized on 21 Feb 2021. The vent diverticulitis was considered medically significant. Treatment for the event included blood transfusion. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event diverticulitis was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded; however association is confounded by medical history of diverticulitis",Not Reported,,Not Reported,Yes,,Not Reported,U,01/28/2021,,,UNK,,Diverticulitis,,,,['Diverticulitis'],1,MODERNA, 1106166,LA,70.0,F,"Blood pressure up and down; Vaccine was purple and not clear in vial; A spontaneous report, was received from a consumer (patient), a 70 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced blood pressure up and down (blood pressure fluctuation), and vaccine was purple and not clear in vial (product colour issue). The patient's current conditions included allergy to dye and anaphylaxis. Concomitant medications were not reported. On 24 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for the prophylaxis of COVID-19 infection. On an unknown date in Feb 2021, after receiving the vaccine, the patient had her blood pressure up and down. The patient stated that the vaccine was purple and not clear in the vial on 24 Feb 2021, and still the pharmacist gave her. The patient was hospitalized for her blood pressure fluctuations. Treatment information was not provided. Action taken with second dose of mRNA-1273 in response to the events was not provided. The outcome of the event, blood pressure up and down was not reported and that of event vaccine was purple and not clear in vial was recovered on 24 Feb 2021. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/24/2021,02/01/2021,,UNK,,Contrast media allergy (Anaphylaxis to dye),,,,"['Blood pressure fluctuation', 'Product colour issue']",1,MODERNA,OT 1106167,CA,85.0,M,"Bell's Palsy; A spontaneous report was received from a consumer concerning a 85-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy. The patient's medical history was not provided. No relevant concomitant medications were reported. On 08 Feb 2021, approximately three days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 013M20A) in the left arm for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient experienced medically significant event Bell's palsy. Treatment details for event Bell's palsy included antiviral medication. Action taken with mRNA-1273 in response to the event Bell's palsy was not reported. The outcome of the event Bell's palsy was not recovered.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/08/2021,02/11/2021,3.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"[""Bell's palsy""]",1,MODERNA,OT 1106168,SC,75.0,F,"Could not stabilize her heart rhythm; Heart beats per minute went up and down; build up of body fluids; A spontaneous report was received from a consumer concerning a 75-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart beats per minute went up and down (atrial fibrillation) and could not stabilize her heart rhythm (arrhythmias). The patient's medical history included three-year history of atrial fibrillation and cardioversion. No concomitant medication were provided. On 21 Jan 2021, patient received her first of two planned doses of mRNA-1273 (Batch Number 042L20A) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, approximately one day prior to the onset of the events, patient received their second of two planned doses of mRNA-1273 (Batch Number 03/L20A) intramuscularly for prophylaxis of COVID-19 infection. On 19 Feb 2021, the patient's heart beats per minute went up and down from 73 bpm to 128 bpm. The patient stayed in atrial fibrillation for four days and on an unknown date the patient went to the Emergency Room (ER). On 24 Feb 2021, Wednesday the patient was admitted to the hospital. Cardioversion was performed to return heartbeat to a normal rhythm as patient's heart rhythm was not stable with intravenous (IV) medication. The patient was buildup of body fluid. Laboratory details included cardioversion. Treatment information for events could not stabilize her heart rhythm (arrhythmias) include Flecainide. Action taken with mRNA-1273 in response to the events heart beats per minute went up and down (atrial fibrillation) and could not stabilize her heart rhythm (arrhythmias) was not reported. The outcome of the events heart beats per minute went up and down (atrial fibrillation) and could not stabilize her heart rhythm (arrhythmias) was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded",Not Reported,,Not Reported,Yes,,Not Reported,Y,01/21/2021,02/19/2021,29.0,UNK,FLECAINIDE,,Medical History/Concurrent Conditions: Atrial fibrillation; Cardioversion,,,"['Arrhythmia', 'Atrial fibrillation', 'Heart rate', 'Oedema']",2,MODERNA,OT 1106169,NJ,,F,"Bronchitis; Arm pain; A spontaneous report was received from a consumer for a 57 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, cough and arm pain and diagnosed with bronchitis. The patient's medical history was not provided. Concomitant product use included alprazolam. On 29 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 029C20A) and on 26 Feb 2021, she received the second of two planned doses of mRNA-1273 (Lot number: 001A21A) intramuscularly in left non dominant arm for prophylaxis of COVID-19 infection. On 26 Feb 2021 in evening around 8 PM, after receiving the vaccine, patient got fever, chills, cough and arm pain. On 01-Mar-2021, her doctor did Covid test and it resulted negative. She was then diagnosed with bronchitis and was prescribed Zithromax as treatment. She wanted to know if she could take Tylenol. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/29/2021,02/26/2021,28.0,UNK,XANAX,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Bronchitis', 'Pain in extremity', 'SARS-CoV-2 test']",2,MODERNA,OT 1106170,MI,71.0,F,"Got heart attack; High blood pressure; Shortness of breath; Hip is paining; A spontaneous report was received from a consumer (Patient's husband) concerning a 71-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart attack, high blood pressure, pain in hip and shortness of breath. The patient's medical history included three by-pass (open) heart surgery in 2020. No relevant concomitant medications were reported. On 25 Feb 2021 Thursday, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 014M20A) intramuscularly for prophylaxis of COVID-19 infection. On 25 Feb 2021, Thursday night, the patient experienced high blood pressure of 189/101 and got a heart attack followed by shortness of breath and the patient hospitalized on 25 Feb 2021 Thursday night. On 26 Feb 2021, Friday at 04:00 PM, the patient was discharged from hospital. The patient experienced hip pain and little high blood pressure than normal. Laboratory details included blood work normal and high blood pressure, 189/101. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, heart attack pain in hip and shortness of breath was not reported. The outcome for event high blood pressure was considered resolving.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: MOD21-043135:Same reporter",Not Reported,,Not Reported,Yes,,Not Reported,N,02/25/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Open heart surgery (Three),,,"['Arthralgia', 'Blood pressure measurement', 'Blood test', 'Dyspnoea', 'Hypertension', 'Myocardial infarction']",1,MODERNA,OT 1106171,WI,,F,"no fetal heartbeat; pregnant and received vaccine; A spontaneous report was received from a 37-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) while pregnant, and there was not fetal heartbeat. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included prenatal vitamins. The consumer received the second of the two planned doses of mRNA-1273 on 26-JAN-2021 (Batch# 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 02-MAR-2021, the patient stated her fetus had no heartbeat. No treatment information was provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events was considered recovered.; Reporter's Comments: This is a case of product exposure during pregnancy for this 37 year old woman with associated event of absent fetal heartbeat. The patient will continue to be contacted for follow-up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,01/26/2021,12/21/2020,,UNK,PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS],,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Abortion spontaneous', 'Exposure during pregnancy']",2,MODERNA,OT 1106172,TX,,F,"She saw blood in stool; A spontaneous report was received from a consumer concerning a female patient (age unspecified) who received Moderna's COVID-19 vaccine (mRNA-1273) and saw blood in her stool. The patient's medical history included urinary tract infection (UTI) and was prescribed antibiotics. No relevant concomitant medications were reported. On 11/Feb/2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 14/Feb/2021, the patient experienced the event after dinner, she saw blood in stool. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event, saw blood in stool was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/11/2021,02/14/2021,3.0,UNK,,,Medical History/Concurrent Conditions: Urinary tract infection,,,['Haematochezia'],1,MODERNA,OT 1106173,NC,,M,"He was paralyzed,couldn't use his legs, hand, got collapsed; Lack of strength; Injection site was annoying, rubbing, scratchy; down deep in his muscle a slight feel pain at injection site; extreme dizziness lasted for a day and a half.; shortness of breath; A spontaneous report was received from a consumer concerning himself, 70 years old, male patient who experienced he was paralyzed, couldn't use his legs, hand, got collapsed/paralysis, injection site was annoying, rubbing, scratchy/injection site pruritus, down deep in his muscle a slight feel pain at injection site/injection site pain, shortness of breath/dyspnoea, lack of strength/weakness, extreme dizziness lasted for a day and a half/dizziness. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) on 24 Feb 2021 intramuscularly for prophylaxis of COVID-19 infection. The patient was paralyzed, he couldn't use his legs, hand, got collapsed. Injection site was annoying, rubbing, scratchy, down deep in his muscle a slight feel pain. He also had shortness of breath, lack of strength and extreme dizziness lasted for a day and a half. Treatment of the events was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event he was paralyzed, couldn't use his legs, hand, got collapsed, injection site was annoying, rubbing, scratchy and down deep in his muscle a slight feel pain at injection site was unknown and of events shortness of breath, lack of strength, extreme dizziness lasted for a day and a half was recovered.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Injection site pain and injection site pruritus are consistent with the known safety profile of the vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/24/2021,,,UNK,,,Medical History/Concurrent Conditions: COVID-19 (No relevant medical history),,,"['Asthenia', 'COVID-19', 'Dizziness', 'Dyspnoea', 'Injection site pain', 'Injection site pruritus', 'Paralysis']",1,MODERNA,OT 1106174,NC,,M,"pneumonia; tested positive for COVID-19; sore arm; A spontaneous report was received from a consumer concerning a 74-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed pneumonia, sore arm and tested positive for COVID19. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included baby aspirin, morphine sulfate, vitamins, and unspecified antihyperlipidemic medication. On 27 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27 Jan 2021, post vaccination, the patient developed sore arm. On 08 Feb 2021, the patient tested positive for COVID19. On 12 Feb 2021, the patient went to the Emergency Room for symptoms and was diagnosed with pneumonia. The patient was not hospitalized. Treatment for the event was not reported. There was no change planned to the dosing schedule of mRNA-1273 in response to the events. The outcome of the events, was unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported event- vaccination site pain and the administration of the mRNA-1273 cannot be excluded. However, the event of Covid-19 is Unlikely related to mRNA-1273. and a very limited information regarding the event (pneumonia) has been provided. However, the subject's concurrent history of COVID-19 may remain as a risk factor for pneumonia.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,01/27/2021,0.0,UNK,MORPHINE SULFATE; VITAMINS NOS; BABY ASPIRIN,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['COVID-19', 'Pneumonia', 'Vaccination site pain']",1,MODERNA,OT 1106175,KY,,F,"a friend died from the vaccine; A spontaneous report was received from a non health care professional, concerning her friend, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and died from the vaccine. The patient's medical history,concomitant history, and lab data was not provided by the reporter. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The patient experienced death after receiving the moderna mRNA1273 vaccine. No further details were provided. The action taken with the second dose of mRNA-1273 in response to the event was not applicable. The outcome of the events, died from the vaccine, were considered as fatal.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,['Sudden death'],1,MODERNA,OT 1106176,TX,70.0,F,"Lost her vision; Dizzy, lightheaded, lightheadedness; Increased heart rate; A spontaneous report was received from a consumer concerning a 70-years-old female patient who was received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of vision, dizziness and increased heart rate. The patients medical history was not provided. No relevant concomitant medications were reported. On 28 feb 2021, approximately three days prior to the onset of events loss of vision, dizziness and increased heart rate, the patient received the first of two planned dose of mRNA-1273(Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 02 mar 2021, The patient had lost her vision, became dizzy lightheaded, which led to an increased heart rate. The patient still had intermittent lightheadedness. The event loss of vision was medically significant. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events loss of vision, dizziness and increased heart rate was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/28/2021,03/02/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Blindness', 'Dizziness', 'Heart rate increased']",1,MODERNA,OT 1106177,MO,58.0,M,"DYSENTERY; NAUSEOUS; CHILLS; SORE ARM; HEADACHE; fever; MUSCLES CRAMPING; SWEATS; Got dizzy; slept a bunch; A spontaneous report was received from a consumer concerning a 58 year old, male patient who experienced dizziness, fever, sweats/hyperhidrosis, nausea, chills, dysentery, slept a bunch/fatigue, sore arm/injection site pain, headache, and muscles cramping/muscle spasm. The patient's medical history included having COVID-19 in December 2020. Concomitant product use not provided. The patient received their first of two planned doses of mRNA-1273 (Batch number 016M20A) on 10-Feb-2021 intramuscularly for prophylaxis of COVID-19 infection. On 11-Feb-2021, around 2 o'clock in the morning the patient got dizzy, got a fever, sweats, nauseous, had chills, he got dysentery and got sick to his stomach. He was sick about one day or so after that. He slept a bunch. He looked bad and started sweating. He had a sore arm for a few days. He also had headaches and his muscles were cramping. Treatment for the event none provided. The outcome of the events were unknown.; Reporter's Comments: Based on the information provided, the event of dysentery is assessed as unlikely as it is infective etiology, the other events are temporarily association with mRNA-1273 administration, a causal association between the reported events and the product use cannot be excluded. Nausea, chills, injection site pain, headache, pyrexia, fatigue are consistent with the safety profile of the vaccine.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,02/11/2021,1.0,UNK,,,Medical History/Concurrent Conditions: COVID-19 (Covid 19 tested positive the Monday before Christmas 21Dec2020.),,,"['Chills', 'Dizziness', 'Dysentery', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Injection site pain', 'Muscle spasms', 'Nausea', 'Pyrexia']",1,MODERNA,OT 1106178,NY,58.0,F,"She felt sick; afraid may have this eye issue for rest of life and concern since a school bus driver she may lose her job; right eye is puffy and hurt(painful; right eye is puffy and hurt(painful; Both eyes started to swell.; had chills; fever; A spontaneous report was received from a consumer concerning a 58 years old, female patient who experienced, both eyes swollen(eye swelling), chills, fever(pyrexia), felt sick(malaise), right eye is puffy and hurt(periorbital swelling), right eye is hurt (eye pain), afraid may have this eye issue for rest of life and concern since a school bus driver she may lose her job (fear). The patient's medical history not included.Concomitant medicine was not reported.No Lab data was reported. On 24 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: 011A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 24 Feb 2021, her both eyes started to swell, felt sick and had chills and fever. Her right eye was puffy and painful. She also afraid that she may lose job.Treatment for the event include cold compress, Benadryl, neomyc-polym-dexamet ointment. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events were reported as unknown.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Chills and fever are consistent with the known safety profile of the vaccine; Sender's Comments: MOD-2021-034769:Case for 1st dose of vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/27/2021,02/24/2021,28.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Chills', 'Eye pain', 'Eye swelling', 'Fear', 'Malaise', 'Periorbital swelling', 'Pyrexia']",1,MODERNA, 1106179,CA,,F,"Idiopathic thrombocytopenic purpura (ITP); A spontaneous report was received from a thirty-one-years old physician reporting for herself, who received Moderna's COVID-19 Vaccine (mRNA-1273). The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received the first of the two planned doses of mRNA-1273 on 24-FEB-2021 (Batch# unknown) intramuscularly on left arm for prophylaxis of COVID-19 infection. On 06-MAR-2021, she experienced Idiopathic thrombocytopenic purpura (ITP) with platelet was 3 x 1000 (units unknown) and was treated with Platelet infusion. Her CBC done on 11-JAN-2021. (baseline) was 238 ( parameter and unit unknown) Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Yes,Yes,,Not Reported,U,02/24/2021,03/06/2021,10.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Full blood count', 'Platelet count', 'Thrombocytopenia']",1,MODERNA,OT 1106180,,,F,"Syncope; Flushing; Blurred vision; Felt like is going to pass out; A spontaneous report was received from a pharmacist concerning a 67-year-old, female patient, and experienced syncope, flushing, blurred vision (vision blurred) and felt like she is going to pass out (presyncope). The patient's medical history, was diabetes type 2, high blood pressure and anxiety. Concomitant medications reported included non specified medications to diabetes type 2, high blood pressure and to anxiety. On 04 Mar 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Lot number: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced syncope, she was flushing and had blurred vision. She felt like she is going to pass out. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, syncope, flushing, blurred vision (vision blurred) and felt like she is going to pass out (presyncope) were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/04/2021,,,UNK,,,Medical History/Concurrent Conditions: Anxiety; Hypertension; Type 2 diabetes mellitus,,,"['Flushing', 'Presyncope', 'Syncope', 'Vision blurred']",2,MODERNA,OT 1106181,NC,,F,"angina; difficulty breathing; throat closing; funny taste in mouth; shooting pain in jaw; hotness; joint pain; redness and raised area at injection site; redness and raised area at injection site; pain in arm; A spontaneous report was received from a consumer, a 74 years old female patient who experienced difficulty breathing/ dyspnea, throat closing / throat tightness, funny taste in mouth / taste disorder, pain in arm / pain in extremity, shooting pain in jaw/ pain in jaw, angina / angina pectoris, joint pain / arthralgia, injection site redness / injection site erythema and raised area at injection site / injection site swelling, and injection site hotness / injection site warmth. The patient's medical history not included. Products known to have been used by the patient, within two weeks prior to the event, included nitroglycerine. On 26 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 014M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Feb 2021, the patient experienced difficulty breathing, throat closing, funny taste in mouth, pain in arm, shooting pain in jaw, angina, joint pain, redness and raised area at injection site and hotness. Treatment for the events included Benadryl, liquid nitro, aspirin, and inhaler. Action taken with mRNA-1273 in response to the events was not provided. The outcomes of the events, difficulty breathing, throat closing, pain in arm, angina, joint pain, redness, raised area at injection site, and hotness, were considered recovered. The outcomes of the events, funny taste in mouth and shooting pain in jaw, were considered not recovered.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Arthralgia, Injection site redness and injection site swelling are consistent with the known safety profile of the vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/26/2021,02/26/2021,0.0,UNK,NITROGLYCERIN,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Angina pectoris', 'Arthralgia', 'Dyspnoea', 'Injection site erythema', 'Injection site swelling', 'Injection site warmth', 'Pain in extremity', 'Pain in jaw', 'Taste disorder', 'Throat tightness']",1,MODERNA,OT 1106182,TX,,F,"Right side body & arm tingling; Swelling of hands and feet (angioedema); Full-body Hives; Hot flashes; Burning sensation on her back; A spontaneous report was received from a consumer who was also a female patient, unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced full body hives, hot flashes, burning sensation on back, swelling of hands and feet/ angioedema, and right side of body tingling/ paresthesia. The patient's medical history was not reported. The concomitant medications were no reported. On 03-MAR 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch- lot number- 029A21A) intramuscularly in the right arm for the prophylaxis of COVID-19 infection. On 03 Mar 2021, the patient stated she had an allergic reaction while driving home. She broke out in hives with hot flashes, burning sensation on her back, swelling of the hands and feet. The patient went to her doctor's office and received a corticosteroid injection. On 04 Mar 2021, she had full body hives and angioedema in hands and feet. The right side of her body and arm were tingling like it was asleep. No problems with breathing reported. Treatment for the events also included Benadryl 300mg, Xyzal (levocetirizine), montelukast, prednisone, Pepcid AC, and Zyrtec. Action taken with mRNA-1273 in response to the events was not provided. The outcomes of the events were considered unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/03/2021,03/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Angioedema', 'Hot flush', 'Paraesthesia', 'Skin burning sensation', 'Urticaria']",1,MODERNA,OT 1106183,CT,,F,"pneumonia-like symptoms; lot of pain; A regulatory authority report was received from a consumer concerning a female patient ( age unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia-like symptoms and was in a lot of pain. Patient's medical history was not provided by the reporter. Concomitant medications were not reported. Laboratory details was not given. On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, prior to receiving mRNA-1273, the patient felt pneumonia-like symptoms and a lot of pain. pneumonia like symptoms with medically significant. Treatment for the events were not reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, pneumonia-like symptoms, a lot of pain were considered unknown.; Reporter's Comments: Although a temporal association exist, there is not enough information to assess the causal association as very limited information regarding this event has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Pain', 'Pneumonia']",1,MODERNA,OT 1106184,IL,58.0,F,"Roof of mouth swelling; Mouth Swelling; Swelling of Airway; difficulty in Breathing; A spontaneous report was received from a Consumer concerning a herself, 58 years- old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, swelling of airway (respiratory tract oedema), difficulty in breathing (dyspnoea), and roof of mouth swelling (palatal swelling), and mouth swelling. The patient's medical history was not provided. The concomitant medications included verapamil, triamterene, and hydrochlorothiazide On 27 Jan 2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On 27 Jan 2021 ,10 minutes after vaccination, the patient developed airway swelling and difficulty breathing. The patient was rushed to the ER, diphenhydramine and epinephrine were given which eventually resolved her symptoms. However, the next day, on 28 Jan 2021, patient noticed that the roof of her mouth was swelling up but resolved after consuming prednisolone as prescribed. Now, patient develops swelling of airways and mouth about 3 hours after any meal. Food allergy source unknown after multiple food allergy test. The events, swelling of airway, difficulty in breathing were also considered medically significant. No Laboratory investigations were provided. The Treatment information included Epinephrine, Benadryl and prednisolone. Action taken with mRNA-1273 in response to the events was unknown. The events, Swelling of Airway, and Difficulty in Breathing were considered resolved on 27 Jan 2021. The event Roof of mouth swelling was considered resolved on 28 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/27/2021,01/27/2021,0.0,UNK,VERAPAMIL; TRIAMTERENE; HYDROCHLOROTHIAZIDE,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Dyspnoea', 'Mouth swelling', 'Palatal swelling', 'Respiratory tract oedema']",1,MODERNA,OT 1106185,NY,64.0,F,"An episode of angioedema; Hives; A spontaneous report was on 05 Mar 2021 received from a consumer concerning, a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives and a second episode of angioedema. � The patient's medical history, as provided by the reporter, included an episode of angioedema after receiving first dose of mRNA-1273. Concomitant products included sertraline hydrochloride 100 milligrams once daily, and zolpidem tartrate 10 milligrams in the evening, diphenhydramine hydrochloride, and cetirizine hydrochloride. The patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly in left arm for prophylaxis of COVID-19 infection on 10 Jan 2021. On 07 Feb 2021, approximately 13 days prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 20 Feb 2021, approximately 13 days after receiving the second dose of vaccine, the patient experienced hives and a second episode of angioedema. Treatment for the reported events was self-administration of an EpiPen as a treatment. � The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the events is not applicable. � The outcome of the events, hives and a second episode of angioedema, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/10/2021,02/20/2021,41.0,UNK,ZOLOFT; AMBIEN; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE],,Medical History/Concurrent Conditions: Angioedema (An episode of angioedema after receiving first dose of vaccine.),,,"['Angioedema', 'Urticaria']",1,MODERNA,OT 1106186,OH,,M,"Vertigo; A spontaneous report was received from a consumer concerning himself, a 70-year-old, male patient who developed vertigo. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12 Feb 2021, approximately 2 days prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (lot#: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 14 Feb 2021, the patient presented to the emergency room with an extreme case of dizziness, nausea, and the inability to turn head his head left or right. The patient was diagnosed with vertigo and was hospitalized for 2 days. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vertigo was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Yes,2.0,Not Reported,U,02/12/2021,02/14/2021,2.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Vertigo'],1,MODERNA,OT 1106187,FL,69.0,F,"Wanted to die; Extreme exhaustion; Slept for 22 hours straight; Fever; Chills; Headache; Tingling in hand, fingers and arm; Numbness in hands and wrist; A spontaneous report was received from a consumer concerning a 69-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme exhaustion, slept for 22 hours straight, fever, chills, headache, wanted to die, numbness in hands and wrist, tingling in arm fingers and hand. The patient's medical history was not provided. Concomitant medications as provided by the reporter included vitamins, turmeric and metformin. On 11 Feb 2021,prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 032L20A) in the left arm for prophylaxis of COVID-19 infection. On 11 Feb 2021, at 9:00 pm ,the patient experienced extreme exhaustion, slept for 22 hours straight, no appetite but was able to have some cereal, and slept for another 13 hours. She also experienced fever, chills, headache, wanted to die, numbness in hands and wrist, tingling in arm fingers and hand. Treatment medication included low dose aspirin. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of events fever and chills were considered as resolved. The outcome of events, numbness in hands and wrist, tingling in arm fingers and hand ,were not resolved. The events extreme exhaustion, slept for 22 hours straight, headache, wanted to die, were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/11/2021,02/11/2021,0.0,UNK,VITAMINS NOS; TURMERIC [CURCUMA LONGA RHIZOME]; METFORMIN,,Medical History/Concurrent Conditions: No adverse event,,,"['Chills', 'Fatigue', 'Headache', 'Hypersomnia', 'Hypoaesthesia', 'Paraesthesia', 'Pyrexia', 'Suicidal ideation']",2,MODERNA, 1106191,,,F,"had a COVID test done which came back positive for COVID/She had mild symptoms of COVID including runny nose and congestion; had a COVID test done which came back positive for COVID/She had mild symptoms of COVID including runny nose and congestion; This is a spontaneous report from a contactable Other healthcare professional, Dentist (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration on 06Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, this Dentist is the patient. She got her first dose of Pfizer COVID-19 Vaccine on 06Jan2021. On 22Jan2021, more than 2 weeks after that first dose, she contracted COVID. She had a COVID test done which came back positive for COVID. She had mild symptoms of COVID including runny nose and congestion. The second dose of Pfizer COVID-19 Vaccine was scheduled for 27Jan2021 but she heard when you have COVID symptoms you cannot take that second dose so she cancelled that appointment. She has not gotten the second dose of Pfizer COVID-19 vaccine. She called to ask if she can get the second dose of Pfizer COVID-19 Vaccine, and if so how long does she need to wait to get it or schedule it. Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: The efficacy of a vaccine varies from patient to patient and can be affected by different factors; however, a contributory role to the reported drug ineffective cannot be ruled out.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/06/2021,01/22/2021,16.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1106192,GA,39.0,F,"throat swelling; dizziness; nausea; mottled skin; tingling of extremities; Anaphylaxis; This is a spontaneous report from a contactable other health care professional. A 39-years-old non-pregnant female patient received BNT162B2(Solution for injection, Lot: EL3302) in left arm, via an unspecified route of administration on 29Jan2021 07:00 at single dose for COVID-19 immunisation. The patient medical history included asthma, gastrooesophageal reflux disease, anxiety, depression, endometriosis. Concomitant medication included sertraline hydrochloride (ZOLOFT), buspirone hydrochloride (BUSPAR), beclometasone dipropionate (QVAR), montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), zolpidem tartrate (AMBIEN). The patient previously took fentanyl, hydrocodone, ciprofloxacin and experienced drug hypersensitivity. The patient not diagnosed with covid-19 before vaccination and covid not tested post vaccination. The patient experienced anaphylaxis, throat swelling, dizziness, nausea, mottled skin, tingling of extremities on 29Jan2021 07:15. The outcome of the events was recovering. The patient received treatment for the adverse event with the drugs Benadryl 50mg IV, SoluMedrol IV.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/29/2021,01/29/2021,0.0,UNK,ZOLOFT; BUSPAR; QVAR; SINGULAIR; ALLEGRA; AMBIEN,,Medical History/Concurrent Conditions: Anxiety; Asthma; Depression; Endometriosis; GERD,,,"['Anaphylactic reaction', 'Dizziness', 'Livedo reticularis', 'Nausea', 'Paraesthesia', 'Pharyngeal swelling']",1,PFIZER\BIONTECH, 1106220,FL,65.0,F,"COVID-19; COVID-19; Fatigue; general achiness; respiratory symptoms; loss of taster intermittent loss of smell; loss of taster intermittent loss of smell; coughing; congestion; sore throat; headache; Exposure to SARS-CoV-2; Nausea; injection site pain; lightheadedness; Stomach pain; extreme exhaustion; This is a spontaneous report received by Pfizer from Agency, (Mfr. Control No: 2020US004529) through a contactable physician. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 29Dec2020 (at the age of 65-year-old) as a single dose for Covid-19 immunisation and also started to receive abaloparatide (TYMLOS, Formulation: injection, Lot number: RT01102, Expiration date: Dec2022) via subcutaneous from 20Dec2020 to an unknown date, at 80 ug, once a day for osteoporosis. The patient medical history, included autoimmune disease-Behcet's disease causing ulcers, osteoporosis and constipation, and all were ongoing. The patient concomitant medication was not reported. On 29Dec2020, the patient experienced injection site pain, fatigue, nausea, Stomach pain and Light headness and the patient believed these symptoms were due to the vaccine. On 04Jan2021, the patient was Exposure to SARS-CoV-2. It was also reported that on 16Jan2021, the patient experienced coughing, fatigue, lost taste/smell, congestion, sore throat, headache, respiratory symptoms, general achiness and also had COVID-19 on an unknown date. It was reported that general achiness and respiratory symptoms possibly related to Covid-19 which resulted in emergency room visit on 16Jan2021. The cough was treated with benzonatate pearls. The following relevant laboratory tests were performed: Rapid COVID-19 (12Jan2021), negative, COVID 19 PCR test (15Jan2021), negative, and chest x-ray (16Jan2021), clear, negative. The action taken in response to the events for abaloparatide was unknown. The outcome of the events COVID-19, light headedness, stomach pain, exposure to sars-cov-2 was unknown, for the events nausea, general achiness, respiratory symptoms, loss of taster intermittent loss of smell, coughing, congestion, sore throat, fatigue, headache was not recovered and for the events injection site pain, extreme exhaustion was recovered on 31Dec2020. Information on batch/lot number was requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Dec2020, and contracted COVID on an unspecified date. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection. Further information like COVID infection date needed for a full meaningful medical assessment.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/20/2020,12/29/2020,9.0,UNK,TYMLOS,Behcet's disease (causing ulcers); Constipation; Osteoporosis,,,,"['Abdominal pain upper', 'Ageusia', 'Anosmia', 'COVID-19', 'Chest X-ray', 'Cough', 'Dizziness', 'Drug ineffective', 'Exposure to SARS-CoV-2', 'Fatigue', 'Headache', 'Nasal congestion', 'Nausea', 'Oropharyngeal pain', 'Pain', 'Respiratory disorder', 'SARS-CoV-2 test', 'Vaccination site pain']",UNK,PFIZER\BIONTECH, 1106233,FL,61.0,M,"significant swelling and redness at the injection site with minimal pain; significant swelling and redness at the injection site with minimal pain; significant swelling and redness at the injection site with minimal pain; weakness; Nausea; mild myalgia; general muscle pain and aches; This is a spontaneous report from a contactable physician (patient). A 61-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date: not reported), via an unspecified route of administration, on 28Jan2021 09:00 AM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. It was not administered at a military facility. He did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. The patient had no relevant medical history and concomitant medications to report.The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: not reported, NDC number: 59267-1000-1), on 09Jan2021 09:30 AM on the left arm for COVID-19 immunization, at the age of 61-year-old. He experienced myalgia at the injection site/pain at inject site after the first dose on 09Jan2021 and resolved on 12Jan2021. The first and second doses of bnt162b2 had the same lot number. On 28Jan2021, the patient received the second dose of bnt162b2. 24 hours later, on 29Jan2021, he experienced mild aches/pain, nausea/malaise. Three days (42-72hours) after 2nd dose, on 31Jan2021, he experienced ""significant redness"" and swelling at injection site with minimal pain. He described it as ""Out of proportion to what should be expected"". The redness and swelling were improving at the time of the report (01Feb2021). He asked if this should be of concern. He also asked if it was possible that the vaccine was given subcutaneously instead of intramuscularly. He developed a good amount of swelling and redness at the injection site. It seemed fine the first day. It took two or more days to develop the swelling. He added that he only had mild myalgia, weakness, and nausea initially on 29Jan2021 after the second dose of the vaccine. Then 48 hours later, he got the large amount of swelling and redness at the injection site. He later clarified he received the first dose of the Pfizer COVID 19 vaccine on 9Jan2021 at 09:30 AM in the left arm. He had some myalgia at the injection site on 09Jan2021 that went away on 12Jan2021. Then he received the second dose of the Pfizer COVID 19 vaccine on 28Jan2021 at 09:00 AM in the left arm. Initially he had no pain. 24 hours later, on 29Jan2021, he had myalgia referring to general muscle pain and aches and nausea that only lasted about two hours. He is mostly concerned now about the significant swelling and redness at the injection site with minimal pain which he noticed 48 to 72 hours after the second dose of the vaccine. He took some Aleve which gave some relief (for significant swelling and redness at the injection site with minimal pain). He asked if this is an expected side effect as it seem out of proportion to him. Outcome of events general muscle pain and aches and weakness was recovered on 30Jan2021. Outcome of event nausea was recovered on 29Jan2021. Outcome of events significant swelling and redness at the injection site with minimal pain was recovering. The reporting physician (patient) assessed the causality between the suspect vaccine and all events as related. He assessed the events ""swelling and redness at the injection site with minimal pain"" as medically significant (serious), while he assessed the other events as non-serious.; Sender's Comments: Based on temporal association and known product safety profile of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date: not reported), the contributory role of the product cannot be totally excluded. The events are known adverse event of the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,01/28/2021,01/29/2021,1.0,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Asthenia', 'Myalgia', 'Nausea', 'Pain', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",2,PFIZER\BIONTECH, 1106256,,,F,"positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms.; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown, Expiration date: Unknown) via an unspecified route of administration on unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested for COVID-19 and found out that she was positive for the infection, positive COVID-19 test with no symptoms. The patient was supposed to have surgery but she was tested for COVID-19 and found out that she was positive for the infection, she have not had any symptoms, she did not interact with anybody and she wears double mask. The outcome of events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Asymptomatic COVID-19', 'COVID-19', 'Drug ineffective']",2,PFIZER\BIONTECH, 1106259,,,F,"patient had the first dose of the Pfizer COVID-19 vaccine on 30Jan2021 and tested positive on 12Feb2021; patient had the first dose of the Pfizer COVID-19 vaccine on 30Jan2021 and tested positive on 12Feb2021; This is a spontaneous report from a contactable consumer via Medical information team. This consumer reported similar events for 2 patients. This is 2nd of 2 reports. A female patient (wife) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had the first dose of the Pfizer COVID-19 vaccine on 30Jan2021 and tested positive on 12Feb2021. The caller wanted to know whether they should repeat the dose or should they wait. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021166986 same reporter, suspect, events, different patient",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,02/12/2021,13.0,UNK,,,,,,"['COVID-19', 'Drug ineffective', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1106271,NY,29.0,M,"""Caller got his 1st dose a week ago (05Feb2021) and was tested positive of Covid-19 today/He had symptoms like headache, fever""; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 29-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC number, UPC number, Batch/Lot number, Expiry date: unknown), via an unspecified route of administration on 05Feb2021 at single dose for covid-19 immunisation. Covid19 vaccine was a Pfizer product. Covid19 vaccine manufacturer was unspecified. Relevant medical history and concomitant medications were reported None. The patient got his 1st dose a week ago (05Feb2021) (reported as 8 days after the first dose) and was tested positive for Covid today (12Feb2021). His 2nd dose was on 28Feb2021. The patient stated, ""I do not have that card."" Investigation assessment was no. Patient was already negative in 2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test and results were positive (drug ineffective) on 12Feb2021. The outcome of event positive COVID-19 was recovered in 2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/05/2021,02/12/2021,7.0,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['COVID-19', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1106287,GA,50.0,M,"diarrhea worsened 2 hours after receiving the vaccine; Ringing in my ear; was already having a flare; Hearing loss was already there and the vaccine actually exacerbated the situation; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6201, first dose) solution for injection intramuscular in the right arm on 24Feb2021 at 17:00 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing irritable bowel syndrome from Mar2020 and acid reflux (esophageal). Concomitant medication included ongoing lansoprazole (PREVACID) for acid reflux (esophageal) from Nov2020. The patient stated his diarrhea worsened 2 hours after receiving the vaccine (24Feb2021 at 19:00) and had diarrhea again around 10 pm. The patient stated hearing loss was already there and the vaccine actually exacerbated the situation in 2021. The patient also experienced ringing in my ear in 2021. The patient's nurse, primary care doctor, and gastroenterologist stated it was okay to receive the vaccine as the patient was in the middle of a flare up with his IBS (inflammatory bowel syndrome) in 2021. Treatment for the event hearing loss exacerbated included unspecified steroids and has been working. The outcome of the events diarrhea worsened and ringing in my ear was unknown. The outcome of the events hearing loss exacerbated and having a flare was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/24/2021,02/24/2021,0.0,PHM,PREVACID,Irritable bowel syndrome,Medical History/Concurrent Conditions: Acid reflux (esophageal),,,"['Condition aggravated', 'Deafness', 'Diarrhoea', 'Tinnitus']",1,PFIZER\BIONTECH,OT 1106289,DE,,F,"nausea; violent headache; chills/shivering; vomiting; cannot sleep; having vivid dreams; trouble thinking; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-Sponsored Program. An 80 (units not provided) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Feb2021 (at the age of 80, units not provided) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 17Feb2021 the patient experienced nausea, violent headache, chills/shivering, vomiting, cannot sleep, having vivid dreams and trouble thinking. It was reported that the patient was hospitalized in the ER (emergency room) 45 minutes after receiving the dose. The clinical course was reported as follows: ""The patient received her first COVID-19 vaccine and ended up in the ER with a violent headache, nausea, chills, shivering, trouble thinking and even sleep was an enemy because she had vivid dreams."" The patient reported that due to these symptoms she was thinking to get the second dose later than 3 weeks. She wanted to know if she should get the second dose. She also wanted to know if she could pass these side effects along (as reported). The clinical outcomes of the events nausea, violent headache, chills/shivering, vomiting, cannot sleep, having vivid dreams and trouble thinking were all unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/17/2021,02/17/2021,0.0,UNK,,,,,,"['Abnormal dreams', 'Chills', 'Cognitive disorder', 'Headache', 'Insomnia', 'Nausea', 'Vomiting']",1,PFIZER\BIONTECH, 1106290,MI,53.0,F,"difficulty controling internal temperature; unable to sweat except feet and hands; chills that start at neck and go down nerve endings of back; hot spot on the back of her neck; felt pressure in her neck and head; felt pressure in her neck and head; face was now numb, ears were numb; decreased sensation in all extremities; started with burning flushing from elbow down to hand; started with burning flushing from elbow down to hand; burning tingling progressed from feet up to her abdomen; This is a spontaneous report from a contactable nurse (the patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ek9231), via an unspecified route of administration in the right arm on 03Jan2021 18:15 (at the age of 53-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: seizure disorder and osteoarthritis. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: levetiracetam (KEPPRA), levetiracetam (KEPPRA XR), pyridoxine hydrochloride (B6), folic acid, vitamin D NOS, and acetylsalicylic acid (BABY ASPIRIN). The patient previously took and had allergies to: H1N1 vaccine, oxcarbazepine (TRILEPTAL), carbamazepine (TEGRETOL), and lacosamide (VIMPAT). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated that about 30 hours after receiving the vaccine, on 04Jan2021 23:00, she started to experience burning flushing from elbow down to hand. She took paracetamol (TYLENOL), went to bed, then the burning tingling progressed from feet up to her abdomen. She stated it felt like she had shingles from below the breast down. The symptoms have continued to evolve, moving up her back. The patient had difficulty controlling internal temperature; she was unable to sweat except feet and hands (unspecified dates). She had chills that start at neck and go down nerve endings of back (unspecified date). She was on gabapentin (NEURONTIN) to control tingling and burning. The patient had a hot spot on the back of her neck. She felt pressure in her neck and head. Her face was now numb, ears were numb, and she had decreased sensation in all extremities. She was currently unable to work. The events were serious due to disability. They involved doctor or other healthcare professional office/clinic visit and emergency room visit. Treatment was received for the events. The patient had a negative saliva COVID test in Jan2021, post vaccination, and a negative nasal swab COVID test in Feb2021. The clinical outcome of the events was not recovered.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE0 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Yes,N,01/03/2021,01/04/2021,1.0,PVT,KEPPRA; KEPPRA XR; B6; FOLIC ACID; VITAMIN D NOS; BABY ASPIRIN,,Medical History/Concurrent Conditions: Osteoarthritis; Seizure,,,"['Body temperature abnormal', 'Burning sensation', 'Chills', 'Feeling hot', 'Flushing', 'Head discomfort', 'Hyperhidrosis', 'Hypoaesthesia', 'Musculoskeletal discomfort', 'Paraesthesia', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 test', 'Sensory loss']",1,PFIZER\BIONTECH, 1106291,WA,68.0,M,"small ischemic stroke; elevated white blood count; fever; body aches; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9269, expiration date May2021), via an unknown route of administration on 15Feb2021 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 Prevention/ immunization. The patient's medical history included a dental procedure on 18Feb2021 for a cracked tooth from an unknown date. The patient received procaine hydrochloride (NOVOCAIN) on 18Feb2021 for the dental procedure. On 18Feb2021 the patient experienced fever, body aches, chills, and a headache; and on an unknown date in Feb2021 the patient experienced a small ischemic stroke. The patient was hospitalized for the ischemic stroke on 19Feb2021. The patient underwent lab tests and procedures which included a Magnetic resonance imaging (MRI) of the brain on 20Feb2021 which showed a small ischemic stroke and white blood cell count which was elevated (in the low 20s) on 19Feb2021 and on 20Feb2021, white blood cell count was normal. Therapeutic measures were taken as a result of the ischemic stroke which included Plavix. The clinical outcome of the ischemic stroke was unknown; fever, body aches and chills were recovered on 19Feb2021; white blood cell count increased recovered on 20Feb2021; headache was not recovered. The patient was hospitalized for three days. The patient mentioned that he was not associating the stroke with the vaccine but rather associates it with the added stress on his body.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/15/2021,02/01/2021,,UNK,NOVOCAIN,,Medical History/Concurrent Conditions: Dental treatment (Dental Procedure); Tooth fracture (cracked tooth),,,"['Chills', 'Headache', 'Ischaemic stroke', 'Magnetic resonance imaging head', 'Pain', 'Pyrexia', 'White blood cell count', 'White blood cell count increased']",1,PFIZER\BIONTECH, 1106292,GA,67.0,F,"BP 142/68; like my throat is closing up; Voice hoarse; chest feeling tight; This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265), via an unspecified route of administration on 05Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and flu vaccine and experienced allergies. The patient was vaccinated on 05Feb2021. Patient was initially hesitant to get vaccine, reported prior bad reaction to flu vaccine. Patient spoke with the pharmacist and decided to proceed with vaccination. On 05Feb2021, approximately 2 minutes after being seated in the observation area, patient began to feel ""like her throat was closing up"". Another employee brought the attention of this RN who notified the pharmacist and other clinic staff. Initial assessment, patient seated, in apparent distress stating, ""I feel like my throat is closing up"". Voice hoarse. 25 mg diphenhydramine hcl (BENADRYL) administered. Patient declined additional 25 mg diphenhydramine hcl stating it made her too sleepy. Patient brought to private monitoring area. VS obtained. HR 78, BP 130/73, SpO2 99%. Reported feeling ""some better"". HR 76, SpO2 97%, BP 106/66; reported ""chest feeling tight"". Decision for epinephrine (Epi) administration. Epi Pen administered to L thigh. HR 89, BP 142/68, SpO2 99%. Patient taken to emergency department (ED). Care tx ED RN. Patient stable upon tx to ED. The patient required emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included diphenhydramine hcl and epinephrine. The outcome of the events was unknown.; Sender's Comments: Based on a close chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/05/2021,02/05/2021,0.0,PVT,,,,,,"['Blood pressure increased', 'Blood pressure measurement', 'Chest discomfort', 'Dysphonia', 'Heart rate', 'Oxygen saturation', 'Throat tightness']",1,PFIZER\BIONTECH, 1106294,IL,84.0,F,"I had periods of dizziness like my atrial fibrillation was acting up every few minutes all day, both days; Left arm was sore for a day; I had periods of dizziness; I was fatigued and took 2 naps each day; This is a spontaneous report from a contactable consumer (patient herself). An 84-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: EN6200), via an unspecified route of administration on the left arm, first dose on 23Feb2021 12:15 at single dose for COVID-19 immunization. Medical history included atrial fibrillation from an unknown date and allergies to penicillin. The patient is not pregnant. No other vaccine received in four weeks. Concomitant medication included cyanocobalamin (B12-VITAMIIN), vitamin b complex (B COMPLEX), calcium (CALCIUM), ascorbic acid (VIT C), and rivaroxaban (XARELTO) from unspecified dates in two weeks. On 24Feb2021, the patient experienced left arm was sore for a day however the day following the vaccination and the day after that (Wed and Thursday) patient had periods of dizziness like her atrial fibrillation was acting up every few minutes all day, both days. Patient was fatigued and took 2 naps each day. No treatment was received for the AEs. Patient did not have COVID prior vaccination and not tested with COVID post vaccination. The outcome of the event left arm was sore for a day was recovered on 25Feb2021, and for the other events, it was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/23/2021,02/24/2021,1.0,UNK,B12-VITAMIIN; B COMPLEX [VITAMIN B COMPLEX]; CALCIUM; VIT C; XARELTO,,Medical History/Concurrent Conditions: Atrial fibrillation; Penicillin allergy,,,"['Atrial fibrillation', 'Dizziness', 'Fatigue', 'Vaccination site pain']",1,PFIZER\BIONTECH, 1106296,MA,82.0,F,"hearing loss in left ear; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), on 24Feb2021 (at the age of 82 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history included known allergies: Keflex. Historical vaccine included: first dose of BNT162B2 lot number=en9581, administration date=03Feb2021 at 02:00 PM, Right arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included warfarin sodium (WARFIN), Spironolactone, Torsemide. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Feb2021at 14:00 AM, the patient experienced Hearing loss in left ear, and tinnitus. No treatment was received for the events hearing loss in left ear and tinnitus. The outcome of the events hearing loss in left ear and tinnitus was not recovered. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/24/2021,02/26/2021,2.0,PHM,TORSEMIDE; WARFIN; SPIRONOLACTONE,,,,,"['Deafness', 'Tinnitus']",2,PFIZER\BIONTECH, 1106297,NY,61.0,F,"partial paralysis on the right side of my face as Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Feb2021 at 14:45 at single dose in left arm for COVID-19 immunisation at the age of 61-year-old. Medical history included Hypertension and Chronic Leukemia in remission. Patient was not pregnant. Concomitant medications included Metoprolol, Hydrochlorothiazide, ponatinib hydrochloride (ICLUSIG), potassium. On 25Feb2021 at 06:45, the patient experienced paralysis on the right side of face as Bell's Palsy. The patient went to the emergency room on 26Feb2021, and the doctors at hospital diagnosed partial paralysis on the right side of face as Bell's Palsy. The patient received Prednisone and VALTREX for 7 days. The patient did not recover from the event. Patient had not tested positive for COVID-19 since having the vaccine. Information on batch/lot number was requested.",Not Reported,,Not Reported,Not Reported,,Yes,N,02/21/2021,02/25/2021,4.0,UNK,HYDROCHLOROTHIAZIDE; ICLUSIG; METOPROLOL; POTASSIUM,,Medical History/Concurrent Conditions: Chronic leukemia of unspecified cell type in remission; Hypertension,,,"[""Bell's palsy""]",1,PFIZER\BIONTECH, 1106298,FL,68.0,M,"Temporary loss of eyesight left eye.; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, in the left arm on 26Feb2021 10:15 at a single dose (at the age of 68-years-old) for COVID-19 immunisation. Medical history included atrial fibrillation (A-fib) and gout. The patient has no known allergies. Concomitant medication included allopurinol and acetylsalicylic acid (ASPIRIN (E.C.). The patient received the first dose of BNT162B2 (lot number was not reported) in the left arm on 29Jan2021 10:15 (at the age of 68-years-old) for COVID-19 immunisation. No other vaccines were administered within four weeks. No COIVD prior vaccination. On 27Feb2021 at 11:00, the patient experienced temporary loss of eyesight left eye. The patient did not receive treatment for the event. No COVID tested post vaccination. The patient recovered from the event in Feb2021. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/26/2021,02/27/2021,1.0,UNK,ALLOPURINOL; ASPIRIN (E.C.),,Medical History/Concurrent Conditions: AFib; Gout,,,['Blindness transient'],2,PFIZER\BIONTECH, 1106299,PA,59.0,F,"arm was very sore when she got up it was swollen and red and hurt terribly; arm was very sore when she got up it was swollen and red and hurt terribly; arm was very sore when she got up it was swollen and red and hurt terribly; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 59 years of age), via an unspecified route of administration in the left arm on 25Feb2021 14:15 (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunisation. Medical history included chronic blood clot in left leg from an unknown date and unknown if ongoing and environmental allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks prior to covid vaccine. She was not pregnant. The patient had not had covid prior vaccination and she had not been tested post vaccination. It was reported that during the night of 25Feb2021 at 11:00 PM, the patient's arm was very sore when she got up it was swollen and red and hurt terribly. So she went to the ER because she had a chronic blood clot in her left leg; there was no clot in her arm but it was still swollen, red and it hurts. She added that she have very bad environment allergies and queried if she should get the second shot. No treatment received for the events. The outcome of the events was unknown; the events resulted to emergency room visit. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/25/2021,02/25/2021,0.0,WRK,,,Medical History/Concurrent Conditions: Clot blood; Environmental allergy,,,"['Vaccination site erythema', 'Vaccination site pain', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 1106300,NC,64.0,F,"swelling and extreme pain in both hands and wrists; swelling and extreme pain in both hands and wrists; This 64- year-old female patient contactable nurse (reported for herself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN9581,), via an unspecified route of administration, on 05Feb2021 at 12:15 PM (at the age of 64-years-old) as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a Hospital. She has had no other vaccines in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient is not pregnant. Historical Vaccine included first dose of BNT162B2 on 14Jan2021 for COVID-19 immunization, lot number EL3247, in left arm. Medical history included: Hypertension and allergies: lisinopril, amlodipine, azithromycin. Concomitant medications included: losartan, protonix, vesicare, citalopram, MVI. calcium. On 07Feb2021, she reported: swelling and extreme pain in both hands and wrists. She went to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and was hospitalized x 3 days. Treatment received included: pain medication, steroid, antibiotic. The outcome of the events was not recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,3.0,Not Reported,N,02/05/2021,02/07/2021,2.0,PVT,LOSARTAN; PROTONIX [OMEPRAZOLE]; VESICARE; CITALOPRAM; CALCIUM; MVI [ASCORBIC ACID;DEXPANTHENOL;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLA,,Medical History/Concurrent Conditions: Hypertension,,,"['Pain', 'Swelling']",2,PFIZER\BIONTECH, 1106303,CT,88.0,F,"broken femur; early morning fall (maybe related); lethargy; memory issues (beyond normal for her); low grade fever; This is a spontaneous report from a contactable consumer. An 88-years-old (non-pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). Concomitant medications included atorvastatin (ATORVASTATIN), gabapentin (GABAPENTIN), lorazepam (LORAZEPAM), losartan (LOSARTAN), metoprolol succinate (METOPROLOL SUCCINATE), pantoprazole (PANTOPRAZOLE), paroxetine (PAROXETINE), and zolpidem (ZOLPIDEM). The patient had no other vaccines in four weeks. The patient had no COVID prior vaccination. On 20Feb2021 at 12:00, the patient had a low-grade fever for 2 days, followed by lethargy and memory issues (beyond normal for her) on the 3rd day (23Feb2021). Finally, on the 4th day (24Feb2021), by early morning, the patient had a fall (maybe related) and a broken femur. The events resulted in emergency room/department or urgent care, hospitalization as the patient was hospitalized for two days due to the events. Treatment for the events was unknown. The patient underwent lab tests and procedures which included Blood test/viral RNA: Negative on 26Feb2021. The events had not resolved. Information on the batch/lot number has been requested.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,,02/20/2021,,PVT,ATORVASTATIN; GABAPENTIN; LORAZEPAM; LOSARTAN; METOPROLOL SUCCINATE; PANTOPRAZOLE; PAROXETINE; ZOLPIDEM,,Medical History/Concurrent Conditions: COPD,,,"['Fall', 'Femur fracture', 'Lethargy', 'Memory impairment', 'Pyrexia', 'SARS-CoV-2 test']",UNK,PFIZER\BIONTECH, 1106304,NY,38.0,M,"he has lost also since he got that shot he had lost 8 pounds in like 4 days. He weighs not like a 117-118 pounds; Headache; His arm was hurting; It is the ringing in the ear; felt like a siren was going both of his ears; This is a spontaneous report from a contactable consumer (parent). A 38-year-old male patient (son) received first dose of BNT162B2 on 05Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. When he received the first one he felt headache a little bit and his arm was hurting and all of a sudden he suffers from tinnitus, It is the ringing in the ear. He is about 5' 9 and he has lost also since he got that shot he had lost 8 pounds in like 4 days. He weighs not like a 117-118 pounds. The outcome of the events was unknown. Information on the Lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none,,,"['Headache', 'Pain in extremity', 'Tinnitus', 'Weight', 'Weight decreased']",1,PFIZER\BIONTECH, 1106306,,,F,"seizure; couldn't move and speak; couldn't move and speak; chills; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (age: 77, unit: unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 24Feb2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced seizure, couldn't move and speak and chills on 26Feb2021. The patient received first dose of Pfizer on 24Feb2021, and experienced a seizure 48 hours later. She was experiencing severe chills, then during the night, woke up with a seizure, couldn't move and speak, didn't go to the ER, no history of seizure, already filed safety report. She wants to know if she can receive the second vaccine. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/24/2021,02/26/2021,2.0,UNK,,,,,,"['Aphasia', 'Chills', 'Movement disorder', 'Seizure']",1,PFIZER\BIONTECH, 1106307,TN,65.0,F,"Patient felt like going to pass out and she did then, she was probably out less than in a minute; Severe headache; Nauseous; Throwing up/Vomiting; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient (weight: 81.65 kg, height 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6201) at single dose, on 22Feb2021, for COVID-19 immunisation. Relevant medical history included thyroid disorder form an unspecified date. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder. On 22Feb2021, the patient experienced sore arm. On 25Feb2021, the patient developed severe headache, nauseous, and vomiting (throwing up) and the patient felt like going to pass out and she did then, she was probably out less than in a minute. The patient described as following: so, on 25Feb2021, the headache increased throughout the day and her nauseousness continued throughout the day and in the afternoon with the pain of the headache she thought she passed out, she vomited that gave her little bit of relief but then she took ""two (not clarified) Advil and went to bed"". Clinical outcome of the adverse events was unknown at time of this report. Patient asked if should be expected the same kind of reaction when she got her second shot.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/22/2021,02/22/2021,0.0,UNK,SYNTHROID,,Medical History/Concurrent Conditions: Thyroid disorder,,,"['Headache', 'Loss of consciousness', 'Nausea', 'Pain in extremity', 'Vomiting']",1,PFIZER\BIONTECH, 1106308,,34.0,F,"confirmed appendicitis; This is a spontaneous report from a contactable Physician. A 34-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9269), via an unspecified route of administration on 04Feb2021 17:30 at SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1.5/30), bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10) and folic acid. The reporter stated that abdominal pain that began at center of abdomen upon waking up at 8 am on 07Feb2021 and progressively got worse throughout the day. Developed nausea and multiple episodes of vomiting around 15:00. Abdominal pain then moved to RLQ, was persistent, dull and achy, worsened with movement (on 07Feb2021, 8:00). Pain was still present throughout the night and the next day, went to the ER for evaluation. There was concern for appendicitis. Labs were overall normal, CT abdomen was equivocal, abdominal and transvaginal ultrasound were normal but examination was concerning. Laparoscopic surgery was performed and confirmed appendicitis on an unspecified date. The patient was hospitalized for the event on an unspecified day. Outcome of the event was unknown.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/04/2021,,,PVT,BLISOVI FE 1.5/30; PROBIOTIC 10; FOLIC ACID,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Appendicitis', 'Computerised tomogram abdomen', 'Laboratory test']",1,PFIZER\BIONTECH, 1106309,NY,54.0,F,"I fainted the next morning; fell down a flight of stairs; I have a fracture on my right thumb; separated shoulder bone; I had whiplash and I have a concussion; I had whiplash and I have a concussion; I am still having dizzy spells; I don't feel well at all; I cannot complete house hold tasks/I can't go to work; I still cannot drive; I got a severe headache and very bad chills; I got a severe headache and very bad chills; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in arm left on 10Feb2021 at 09:30 as a single dose for COVID-19 immunisation. Medical history included Crohn's disease and hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included azathioprine, levothyroxine, estrogens conjugated, medroxyprogesterone acetate (PREMPRO) and infliximab (REMICADE), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 brand: Pfizer (lot number: EL3247) on 20Jan2021 at 12:15 PM, administered in left arm for COVID-19 immunization. On Wednesday, 10Feb2021, the patient received her 2nd shot of the Pfizer vaccine at 9:30am at the hospital. During the night (10Feb2021), got a severe headache and very bad chills. She fainted the next morning (11Feb2021) and fell down a flight of stairs. She has been off work since. She has a fracture on her right thumb and a separated shoulder bone. She had whiplash and a concussion. She was still having dizzy spells, doesn't feel well at all. She cannot complete household tasks, still cannot drive and can't go to work. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Jun2020 and 12Nov2020 [{covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test date=19Jun2020 and 12Nov2020, covid test result=Negative}. Therapeutic measures were taken as a result of all events. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/10/2021,0.0,PVT,AZATHIOPRINE; LEVOTHYROXINE; PREMPRO; REMICADE,,Medical History/Concurrent Conditions: Crohn's disease; Hypothyroidism,,,"['Chills', 'Concussion', 'Dizziness', 'Fall', 'Hand fracture', 'Headache', 'Impaired driving ability', 'Impaired quality of life', 'Joint dislocation', 'Malaise', 'Post-traumatic neck syndrome', 'SARS-CoV-2 test', 'Syncope']",2,PFIZER\BIONTECH, 1106310,PA,46.0,F,"Bell's palsy; This is a spontaneous report from a contactable healthcare professional. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, administered in left arm on 26Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bell's palsy on 01Mar2021. The event was reported to have resulted in emergency room/department or urgent care visit. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association, the known safety profile of the COVID-19 vaccine, and lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported bell's palsy and the suspect administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/26/2021,03/01/2021,3.0,PVT,,,,,,"[""Bell's palsy""]",1,PFIZER\BIONTECH, 1106311,,,F,"double pneumonia and sepsis; double pneumonia and sepsis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 30Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history was chronic obstructive pulmonary disease (COPD). The patient previously took prednisone for COPD. She has a history of COPD and prior to getting her first Pfizer vaccine, she was on prednisone and antibiotics and was not feeling well. Concomitant medications were not reported. When she got her first vaccine on 30Jan2021, she started having problems breathing and a high fever and thought it was related to the vaccine. She was admitted to the hospital last Tuesday and was diagnosed with double pneumonia and sepsis. The doctor said it was not related to the vaccine. She got out of the hospital on Saturday. She is still on prednisone and antibiotics and now on oxygen all the time. She is getting mixed messages from her doctors on whether or not to get her second vaccine tomorrow. Some say yes, others no. She has not felt well for the last 5 weeks. The patient underwent lab tests and procedures which included body temperature: high fever on an unspecified date. The outcome of the events was unknown.; Sender's Comments: Based on the information available the reported events are considered not related to suspect drug.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/30/2021,,,UNK,,,Medical History/Concurrent Conditions: COPD,,,"['Body temperature', 'Pneumonia', 'Sepsis']",1,PFIZER\BIONTECH, 1106312,NC,73.0,M,"Episodes (seizure-like appearance),; left arm and leg muscle tension/contraction (clutching of hand, raising of leg); leftward face contortion; left arm and leg muscle tension/contraction (clutching of hand, raising of leg); extreme pain along entire left side; This is a spontaneous report from a contactable consumer. A 73-years-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3248, via an unspecified route of administration from 16Jan2021 14:30 at SINGLE DOSE in left arm (at the age of 73 years), via an unspecified route of administration on 06Feb2021 Lot number EN9581 at SINGLE DOSE in right arm (at the age of 73 years) for covid-19 immunisation. The patient did not have another vaccine in four weeks. Medical history included type 2 diabetes mellitus, blood pressure increased, and blood cholesterol increased. Concomitant medication included loteprednol etabonate (LOTREL), acetylsalicylic acid (ASPIRIN), atorvastatin (LIPITOR), clopidogrel bisulfate (PLAVIX), insulin glargine (LANTUS), empagliflozin (JARDIANCE), metformin (METFORMIN), and liraglutide (LIRAGLUTIDE). The patient experienced episodes (seizure-like appearance), on 27Jan2021 12:00 with outcome of not recovered, left arm and leg muscle tension/contraction (clutching of hand, raising of leg) on 27Jan2021 12:00 with outcome of not recovered, leftward face contortion on 27Jan2021 12:00 with outcome of not recovered, extreme pain along entire left side (pain) on 27Jan2021 12:00 with outcome of not recovered. All events are reported as hospitalization and disability. As a result of the patient visited the doctor or other healthcare professional office/clinic visit, Emergency room/ department or urgent care and hospitalization for 7 days. Therapeutic measures were taken as a result of episodes (seizure-like appearance), (seizure), left arm and leg muscle tension/contraction (clutching of hand, raising of leg) (muscle tightness), leftward face contortion (muscle twitching), and extreme pain along entire left side (pain). Treatment included IV steroids and oral steroids. The patient did not have COVID-19 prior to vaccination and the patient did not have COVID test post vaccination.",Not Reported,,Not Reported,Yes,7.0,Yes,N,01/16/2021,01/27/2021,11.0,UNK,LOTREL [LOTEPREDNOL ETABONATE]; ASPIRIN [ACETYLSALICYLIC ACID]; LIPITOR [ATORVASTATIN]; PLAVIX; LANTUS; JARDIANCE; METFORMIN; LIRAGLUTIDE,,Medical History/Concurrent Conditions: Blood pressure increased; High cholesterol; Type II diabetes mellitus,,,"['Muscle contractions involuntary', 'Muscle tightness', 'Muscle twitching', 'Pain', 'Seizure']",1,PFIZER\BIONTECH, 1106313,,,F,"Bleeding; Pain; burning; Bruising; This is a spontaneous report from a Non-contactable consumer reporting for herself. A 53-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration, administered in right arm on Feb2021 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced bleeding on Feb2021 with outcome of recovered , pain on Feb2021 with outcome of recovered with sequelae , burning sensation on Feb2021 with outcome of recovered with sequelae , bruising on Feb2021 with outcome of recovered with sequelae. Bleeding was considered an Important Medical Event. Course of the event: Pain, burning and bleeding immediately after injection. Bleeding stopped right away with a band-aid. Burning subsided within a few hours. Pain went away after 72 hours except it continues to hurt when sleeping on that side (right side). Bruising started about 3 days after the injection and took approximately 10 days to resolve. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/01/2021,0.0,UNK,,,,,,"['Burning sensation', 'Contusion', 'Haemorrhage', 'Pain']",1,PFIZER\BIONTECH, 1106314,NC,61.0,F,"Fluid buildup in lungs. Than pneumonia set in.; Fluid buildup in lungs. Than pneumonia set in.; Weakness; lethargic; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) taken for an unspecified indication, start and stop date were not reported. The patient experienced fluid buildup in lungs. than pneumonia set in, weakness and lethargic on 15Feb2021. Therapeutic measures were taken as a result of all the events which includes Medicine and breathing treatments. Outcome of the events was recovering.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/13/2021,02/15/2021,2.0,UNK,PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL],,,,,"['Asthenia', 'Lethargy', 'Pneumonia', 'Pulmonary oedema']",1,PFIZER\BIONTECH, 1106315,,,F,"headache/migraine; shoulder and neck pain; shoulder and neck pain; feeling tired; her stomach was not in the best shape; Digestive distress; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: unknown, via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history Guillain-Barre syndrome. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for COVID-19 immunization and experienced 3 ""rough days."" The patient wanted information on some ""residual"" side effects that she is experiencing after receiving the COVID-19 vaccine, she received the second dose of the vaccine and presented the following side effects: headache/migraine that is diminishing, feeling tired, shoulder and neck pain or headache-type of reaction, her stomach was not in the best shape but she was tolerating food. She had been checked by two doctors and they can't find anything that could be causing this, she does not have a fever. The reporter is a patient with Guillain-Barre syndrome. She tried taking paracetamol (TYLENOL) but it did not make too much except for making blisters. She was a little concerned about her situation and stated that she wanted to make sure that she will be alright. During the call, she mentioned that one nurse told her that after receiving the vaccine she was on bed for 3 days and that other colleague of her was ""not right"" 6 days after receiving the vaccine she also knows that there are people who have some digestive distress after receiving the vaccine and she believes that her migraine/headache was causing her to have a digestive distress. She mentioned that after receiving the first shot of the vaccine she had 3 ""rough days."" The patient was recovering from the headache/migraine; while unknown for the rest of the events. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: Guillain-Barre syndrome,,,"['Abdominal discomfort', 'Arthralgia', 'Dyspepsia', 'Fatigue', 'Migraine', 'Neck pain']",2,PFIZER\BIONTECH, 1106316,FL,67.0,M,"developed a rash in my back and groin that did not go away; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received the second dose of bnt162b2 (Lot number was not reported), via an unspecified route of administration in the left arm on 10Feb2021 09:30 AM (at the age of 67-year-old) at single dose for COVID-19 immunization. Medical history included anxiety and some lactose intolerance. Concomitant medications included venlafaxine; fluoxetine hydrochloride (PROZAC); azelastine hydrochloride, fluticasone propionate (DYMISTA); amlodipine; and atorvastatin calcium (ATORVAS). The patient previously took lisinopril and experienced drug allergy. The patient previously received the first dose of bnt162b2 via an unspecified route of administration on the left arm on 22Jan2021 09:30 AM (at the age of 67-year-old) at single dose for COVID-19 immunization. Approximately 5 days after receiving the 2nd Covid 19 vaccine on 15Feb2021 12:00, the patient developed a rash in his back and groin that did not go away until 3 days ago when he was prescribed Prednisone 20 mg (2 a day) by an allergist. Prior to the Prednisone the rash was very persistent and increasing in intensity. The patient didnot know if it had to be with the vaccine, but five days later and did not respond to antihistamines or over the counter ointments for rash. No covid prior vaccination nor covid tested post vaccination. The event resulted in Emergency room/department or urgent care. The outcome of the event was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,02/15/2021,5.0,PHM,VENLAFAXINE; PROZAC; DYMISTA; AMLODIPINE; ATORVAS,,Medical History/Concurrent Conditions: Anxiety; Lactose intolerance,,,['Rash'],2,PFIZER\BIONTECH, 1106317,NY,69.0,F,"Blacked out; fractured nose; fainting; very tired and cold; very tired and cold; light headed; thirsty; nausea; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9266), via an unspecified administered in the left arm on 13Feb2021 at 08:15 AM at SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Medical history included arthritis (No chronic health conditions besides arthritis). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), simvastatin, and colecalciferol (D3). The patient previously took cipro [ciprofloxacin hydrochloride] and experienced allergies. Historical vaccine includes first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 at 5:00 PM for COVID-19 immunisation. It was reported that for 2 days, patient was very tired and cold. At day 4 while at her trainer, the patient experienced light headed, thirsty, nausea, and had blacked out. All tests were normal at emergency room (ER), but have fractured nose. The patient wanted to understand if this fainting can be related to the second shot. Cardiologist said no problems in the heart. All events started on 17Feb2021. There was no treatment received for all events. The patient had COVID test post vaccination via nasal swab on 17Feb2021 which showed negative result. On an unspecified date in 2021, the patient recovered from all events.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/17/2021,4.0,UNK,EFFEXOR; SIMVASTATIN; D3,,Medical History/Concurrent Conditions: Arthritis (No chronic health conditions besides arthritis),,,"['Dizziness', 'Facial bones fracture', 'Fatigue', 'Feeling cold', 'Investigation', 'Loss of consciousness', 'Nausea', 'SARS-CoV-2 test', 'Syncope', 'Thirst']",2,PFIZER\BIONTECH, 1106319,OR,79.0,M,"gradually increasing pain in upper chest, which became severe; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received BNT162B2 (BNT162B2; Batch/Lot number and expiry date was not reported) via an unspecified route of administration, administered in Arm Right on 25Feb2021 as SINGLE DOSE for covid-19 immunization. Medical history included diabetes mellitus. Concomitant medications included acarbose (ACARBOSE), sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]), metformin (METFORMIN) and losartan (LOSARTAN) all taken for unspecified indications, start and stop dates were not reported. The patient previously took denoral [risperidone] and darvon [betahistine mesilate] and experienced allergies. The patient experienced gradually increasing pain in upper chest, which became severe on 26Feb2021 at 20:00. It was reported that beginning in evening of day following vaccination: gradually increasing pain in upper chest, which became severe. Went to ER; tests there ruled out heart Involvement; referred to regular physician for follow-up (appointment booked for 03Mar2021). Pain slightly better when patient left ER, gradually subsided overnight and following day; pain gone on second following day. The patient underwent lab tests and procedures which included investigation: Test for heart involvement on an unspecified date (Tests there ruled out heart involvement). The outcome of the event was recovered. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/25/2021,02/26/2021,1.0,PVT,ACARBOSE; JANUVIA [SITAGLIPTIN PHOSPHATE]; METFORMIN; LOSARTAN,,Medical History/Concurrent Conditions: Diabetes,,,"['Chest pain', 'Investigation']",1,PFIZER\BIONTECH, 1106320,,77.0,F,"6 hours of AFIB/taking a medication for AFIB and have not had AFIB for 3 years; 6 hours of AFIB/taking a medication for AFIB and have not had AFIB for 3 years; This is a spontaneous report from a non-contactable consumer (patient herself). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6203), via an unspecified route of administration on the left arm, on 26Feb2021 10:15, at a single dose, for covid-19 immunization. Medical history included allergies: bee stings and sulfa drugs, AFIB (not had AFIB for 3 years) and, had a confirmed case of COVID on Jan2021 (reported as 1 month before vaccination). Concomitant medication included unspecified medication for AFIB. The patient experienced 6 hours of AFIB on 27Feb2021 10:15, 24 hours after first dose. The patient was taking a medication for AFIB (concomitant medication) and have not had AFIB for 3 years. The patient recovered from the adverse event on 27Feb2021 16:15 with no treatment received for it. The patient was not covid-tested post-vaccination. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/26/2021,02/27/2021,1.0,UNK,,,Medical History/Concurrent Conditions: AFib (taking a medication for AFIB and have not had AFIB for 3 years); Bee sting hypersensitivity; COVID-19 (confirmed case of COVID 1 month before vaccination); Sulfonamide allergy,,,"['Atrial fibrillation', 'Disease recurrence']",1,PFIZER\BIONTECH, 1106321,HI,46.0,M,"right side face paralysis/Bell's palsy; numbness in mouth; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9264, via an unspecified route of administration, administered in left arm on 09Feb2021 as single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included nebivolol hydrochloride (BYSTOLIC), atorvastatin (LIPITOR [ATORVASTATIN]), hydrochlorothiazide and telmisartan (MICARDIS HCT). On 22Feb2021, the patient started to feel numbness in mouth. On 28Feb2021, the patient experienced right side face paralysis. The patient went to the ER because the patient was worried it was signs of impending stroke. ER diagnosed with Bell's palsy on 01Mar2021. The patient received unspecified treatment. The outcome of the events was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/22/2021,13.0,MIL,BYSTOLIC; LIPITOR [ATORVASTATIN]; MICARDIS HCT,,Medical History/Concurrent Conditions: Hypertension,,,"['Facial paralysis', 'Hypoaesthesia oral']",1,PFIZER\BIONTECH, 1106322,,80.0,F,"bleeding from ileostomy; abdominal pain; This is a spontaneous report from a non-contactable pharmacist. An 80-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), intramuscular on 28Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took Iodine, Levaquin and Morphine and experienced allergies. It was unknown if the patient received other vaccines in four weeks. The patient experienced abdominal pain and bleeding from ileostomy on 01Mar2021 at 11:00PM. The events resulted in emergency room/department or urgent care and hospitalization. The patient had no COVID prior vaccination and had not tested post vaccination. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Based on the information available the events abdominal pain and bleeding from ileostomy are attributed to intercurrent medical conditions that were not related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/28/2021,03/01/2021,1.0,UNK,,,,,,"['Abdominal pain', 'Haemorrhage']",1,PFIZER\BIONTECH,OT 1106323,WA,,F,"Sepsis; double pneumonia; This is a spontaneous report from a contactable consumer (patient's daughter). A 78-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included COPD from an unknown date. The patient's concomitant medications were not reported. Patient on tuesday (assessed as 2021) was hospitalized with double pneumonia and sepsis then was in the hospital until Saturday(assessed as 2021), when she was released. Patient is still on a breathing machine, which is not normal for her, and reporter is not sure if she should get the second dose of the vaccine which is scheduled for tomorrow since patient is still on antibiotics and Prednisone (assessed as treatment for sepsis and pneumonia). The outcome of the events was unknown. Information about lot/batch number has been requested.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/30/2021,,,UNK,,,Medical History/Concurrent Conditions: COPD,,,"['Pneumonia', 'Sepsis']",1,PFIZER\BIONTECH, 1106324,AZ,91.0,F,"hardness at injection site; has an area on her arm that is 3 inches in diameter that was red and swollen at the injection site.; has an area on her arm that is 3 inches in diameter that was red and swollen at the injection site; This is a spontaneous report from a contactable nurse reporting for her friend (patient). A 91-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration, administered in arm Right on 18Feb2021 14:00 at single dose for covid-19 immunisation. Medical history included stage 3 kidney disease, colon cancer, breast cancer and radiation from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced hardness at injection site and has an area on her arm that is 3 inches in diameter that was red and swollen at the injection site on 28Feb2021. The nurse reported that her friend got the first injection of the Covid-19 vaccine on 18Feb2021. She was fine and did not have any reactions. Yesterday she showed the nurse an area on her arm that was 3 inches in diameter that was red and swollen at the injection site. The nurse adds that she told her friend to apply ice to the area but she did not do that last night. Her friend said the area did not hurt. The nurse adds that it is strange that it appeared 10 days later. The patient did not recover from the events. Information about lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship and known product safety profile, causality between reported vaccination site reactions and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/28/2021,10.0,PVT,,,Medical History/Concurrent Conditions: Breast cancer female; Colon cancer; Radiation therapy; Renal disease,,,"['Vaccination site erythema', 'Vaccination site induration', 'Vaccination site swelling']",1,PFIZER\BIONTECH, 1106325,OK,43.0,M,"Acute Pancreatitis; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9267), via an unspecified route of administration in the right arm on 23Feb2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. Patient had no known allergies. Concomitant medications included losartan, amlodipine and omeprazole. The patient was previously administered with the first dose of BNT162B2 (lot number: EN5318) on 26Jan2021 at 08:45 in the left arm for COVID-19 immunization. No other vaccine in four weeks. The patient experienced acute pancreatitis on 24Feb2021 07:00. The patient was hospitalized for acute pancreatitis for 2 days. The patient self-admitted into ER and was admitted into hospital for observation. On unspecified date in 2021, patient underwent FMP, complete blood count (cbc) and chem-20 labwork which determined that no history to contribute to chief complaint and diagnosis. Treatment administered for the events included IV fluids and unknown medications. No covid prior vaccination. Covid test post vaccination included covid test type post vaccination: Nasal Swab on 27Feb2021 with negative result. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.",Not Reported,,Not Reported,Yes,2.0,Not Reported,N,02/23/2021,02/24/2021,1.0,PUB,LOSARTAN; AMLODIPINE; OMEPRAZOLE,,,,,"['Full blood count', 'Investigation', 'Laboratory test', 'Pancreatitis acute', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1106326,,,M,"acute severe ITP; The initial case was missing the following minimum criteria: literature report without causality. Upon receipt of follow-up information on 01Mar2021, this case now contains all required information to be considered valid. This is a literature report. A 22-year-old healthy male with no medication use received the Pfizer-BioNTech BNT16B2b2 mRNA vaccine through his work as an emergency department employee. On day three, post-vaccination, he experienced widespread petechiae and gum bleeding, which prompted his presentation. He was current on his vaccines, including yearly influenza, with no history of adverse reactions. He denied respiratory and gastrointestinal complaints or a history of infection. He had no personal or family history of bleeding or autoimmune dis-ease. Vital signs and the remainder of his exam were normal. Laboratory tests revealed normal white-cell count, hemoglobin, and severe thrombocytopenia with a platelet count of 2 x 109/L. Two months prior to receiving the vaccine, the patient was evaluated at an outpatient clinic for upper respiratory symptoms. His PCR assay returned negative for SARS-CoV-2, and complete blood count was unremarkable with a normal platelet count of 145 x 109/L (reference range, 140-400 x 109/L). The upper respiratory symptoms resolved within a few days, and the patient had no further complaints. However, as a precautionary measure, one-week post outpatient evaluation, he was again tested for SARS-CoV-2, which returned negative. At the emergency department on day 3, post-vaccination, the following labs were normal or negative: prothrombin time, partial thromboplastin time, fibrinogen, blood urea nitrogen, creatine, electrolytes, bilirubin, Lactate dehydrogenase, alkaline phosphatase, albumin, globulin, total protein, and haptoglobin. The aspartate aminotransferase (42) and alanine aminotransferase (90) were mildly elevated; however, they normalized the next day. Additionally, he tested negative for HIV, Hepatitis B, Hepatitis C anti-body, and Epstein-Barr Virus serology. A nasopharyngeal swab also returned negative for SARS-CoV-2 antigen. The patient was then admitted and given dexamethasone 40 mg daily for 4 days, a platelet transfusion, and intravenous immunoglobulin at 1 g/kg for 2 days. Immunologic studies performed on day 6 for Rheumatoid factor, antibodies for Cyclic Citrullinated Peptide, Anti Centromere, Chroma-tin IgG, dsDNA, Jo1, Ribosomal P Protein, Ribonucleoprotein, Scleroderma, Smith, Sjogren's Syndrome B, Sm/Rnp IgG, AntinuclearAntibody (<1:80, normal <1:80) were normal. However, Sjogren's Syndrome A antibody (2.8) was elevated (normal <1 AI). On day six, post-vaccination, petechiae and oral bleeding decreased, and the patient was discharged with a platelet count of 28 x 109/L. Based on the presentation, a platelet count <100 x 109/L, and the exclusion of alternative causes, a diagnosis of ITP wasmade. At follow up, on day 11, the patient's platelet count normalized to173 x 109/L, and the patient tested positive for plasma IIb/IIIa and Ia/IIa platelet autoantibodies. Sjogren's Syndrome A antibody decreased from 2.8 on day 6 to 1.5 (normal <1 AI). Moreover, complement C3 (94) was normal (reference range, 79-152 mg/dL), while complement C4(10.9 mg/dL) was low (reference range, 16-38 mg/dL). On day 34 a repeat of the patient's abnormal immunologic studies showed a normal value of both Sjogren's syndrome A antibody (SSAAB: <0.2) and Complement C4 (27.6 mg/dL). Additionally, SARS-CoV-2 IgG antibody testing was performed to rule out that a previous COVID-19 infection elicited the ITP experienced on day 3. However, SARS- CoV-2 IgG was negative. As of 16Feb2021, and since the patient's discharge on day6, he remains healthy without any evidence or symptoms of autoimmune disease. This is the first case published in the medical literature of an individual, with no other cause identified and no associated illness, experiencing ITP after receiving the Pfizer-BioNTech vaccine. The temporal relationship of the patient's presentation 3 days post-vaccine administration suggests, but does not prove, the vaccine may be linked to the patient's ITP. Additionally, the rapid and severe drop in platelet count to 2 x 109/L is reminiscent of the abrupt onset observed in drug-induced thrombocytopenia, which further suggests a recent etiology. However, it must be noted that the incidence of ITP is about 3.3 per 100 000 adults/year. Therefore, it is also plausible that this patient's diagnosis was purely coincidental, given that the country has administered over 12 million vaccines to date. Addition-ally, 43 448 participants were included in the Pfizer-BioNTech trial, and no ITP was reported. Moreover, considering the low complement C4 (10.9 mg/dL), mildly elevated SSA Ab (1.5), and 2 months prior, the platelet count (145 x 109/L) was near the lower limit, it is difficult to exclude alternative causes, such as an underlying autoimmune condition with pre-existing ITP. In this scenario, the ITP became clinically apparent following the vaccine, though this patient never manifested symptoms suggestive of autoimmune disease. This case was reported to the FDA's Vaccine Adverse Events Reporting System (VAERS) and is valuable both for post-approval pharmacovigilance and as a foundation for clinicians to evaluate future patients with suspected ITP. Rare vaccination events are important, but do not diminish the enormous utility of vaccination and the well-documented safety profile 2 of the Pfizer-BioNTech BNT16B2b2 mRNA vaccine. No follow-up attempts possible. No further information expected.; Sender's Comments: The young adult having extremely low platelet 3 days presented with skin/subcutaneous bleeding following vaccination, a contributory role of the vaccine use therefore cannot be fully excluded in triggering the event onset. Meanwhile, the adult experienced upper respiratory symptoms prior to the vaccination having positive autoimmunological biomarkers positive including Sjogren's Syndrome A antibody elevated, tested positive for plasma IIb/IIIa and Ia/IIa platelet autoantibodies, complement C4 low, a underlying autoimmune condition with pre-existing ITP might not be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Yes,Yes,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Thrombopenia,,,"['Activated partial thromboplastin time', 'Alanine aminotransferase', 'Aspartate aminotransferase', 'Blood albumin', 'Blood alkaline phosphatase', 'Blood bilirubin', 'Blood creatine', 'Blood electrolytes', 'Blood fibrinogen', 'Blood lactate dehydrogenase', 'Blood urea', 'Epstein-Barr virus test', 'Globulin', 'HIV test', 'Haemoglobin', 'Haptoglobin', 'Hepatitis B virus test', 'Hepatitis C antibody', 'Immune thrombocytopenia', 'Investigation', 'Platelet count', 'Protein total', 'Prothrombin time', 'SARS-CoV-2 antibody test', 'SARS-CoV-2 test', 'Vital signs measurement', 'White blood cell count']",UNK,PFIZER\BIONTECH, 1106328,IA,,F,"pneumonia; congestion; coughing; sore throat; This is a spontaneous report from a contactable consumer. This consumer reported for a 97-year-old female patient (mother). This 97-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6200), dose 1 , single dose via an unspecified route of administration in the right arm on 18Feb2021 for COVID-19 vaccination. Medical history included COVID-19 on an unknown date in Oct2020, colon cancer, congestive heart failure and had a pacemaker. Concomitant medications were not reported. On 24Feb2021 the patient had pneumonia, congestion, coughing and sore throat. She was on oxygen and does not use it all the time and guaifenesin (MUCINEX). Treatment was received for pneumonia, congestion, coughing and sore throat. The clinical outcome of pneumonia, congestion, coughing and sore throat was not recovered.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/24/2021,6.0,UNK,,,Medical History/Concurrent Conditions: Colon cancer (her mother had colon cancer); Congestive heart failure (her mother has a pacemaker and a history of Congestive Heart Failure); COVID-19 (Verbatim: COVID-19),,,"['Cough', 'Nasal congestion', 'Oropharyngeal pain', 'Pneumonia']",1,PFIZER\BIONTECH, 1106329,,,U,"anaphylactic reaction; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that a patient had an anaphylactic reaction following a single dose of the Pfizer BioNTech COVID-19 vaccine. Because it is contraindicated for the patient to take the second dose, she is finding the best way to protect the patient from COVID-19. She wants to know the duration of coverage of the vaccine. She said she knows that after a single dose, the vaccine is 92.6% effective. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known on available information and known drug profile, a possible causal relationship cannot be excluded between the suspect product and the event anaphylactic reaction. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,['Anaphylactic reaction'],1,PFIZER\BIONTECH, 1106330,CA,82.0,M,"Pemphigus; Hives in the back; This is a spontaneous report from a contactable physician (patient). An 82-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL 1284), via an unspecified route of administration, on the left arm, on 30Dec2020 at a single dose for Covid-19 immunisation. Medical history included glaucoma, age-related macular degeneration (AMD), arrhythmia. The patient has no known allergies. The patient did not receive other vaccine in four weeks. The patient has no Covid prior vaccination and not Covid tested Concomitant medications included nebivolol hydrochloride (BYSTOLIC), rosuvastatin calcium (CRESTOR), and timolol. On an unspecified date, the patient developed hives in the back within a week after 1st shot and broke out in blisters over upper body 3 wks after 2nd shot of vaccine. Skin biopsy (Bx) done to confirm Pemphigus. Treatment for the events was Kenalog 60 mg IM/ also 3 wks later prednisone po. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event Pemphigus cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,12/30/2020,,,PVT,BYSTOLIC; CRESTOR; TIMOLOL,,Medical History/Concurrent Conditions: Age-related macular degeneration; Arrhythmia; Glaucoma,,,"['Biopsy skin', 'Pemphigus', 'Urticaria']",1,PFIZER\BIONTECH, 1106331,SC,70.0,M,"developed two blood clots in his right calf; pain in his leg; This is a spontaneous report from a contactable consumer reporting for himself. A 70-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN9581/expiration date: not provided), via an unspecified route of administration, on 04Feb2021 (at the age of 70 years old) as a single dose for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL3249/expiration date: not provided), via an unspecified route of administration, on 15Jan2021 (at the age of 70 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included was not provided. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), meloxicam, an allergy medication and anti-depressants. On 19Feb2021, the patient reported that he developed two blood clots in his right calf, one towards his ankle and one towards his knee and pain in his leg which required hospitalization on 22Feb2021. The patient was discharged on the same day, 22Feb2021. Relevant lab data included: blood test on 22Feb2021 were done to determine what medication to put him on. The results of the blood test was unknown. Treatment received for the event thrombosis included abixaban (ELIQUIS) tablets as a blood thinner. The patient reported he never had blood clots in his life. The outcome of the events thrombosis and pain in leg was unknown.",Not Reported,,Not Reported,Yes,1.0,Not Reported,U,02/04/2021,02/19/2021,15.0,UNK,BABY ASPIRIN; MELOXICAM,,,,,"['Blood test', 'Pain in extremity', 'Thrombosis']",2,PFIZER\BIONTECH, 1106332,,,F,"I was lethargic; had no energy; appetite was gone; nauseous; head was a little dizzy, especially when I lay down/dizzy spells; I also felt unbalanced; I was shaky; I was unable to sit or stand up by myself. I was so weak.; Whiplash; fainted or passed out; fallen down the whole flight of stairs; I had no recollection on how I got there.; acromioclavicular joint separation; right thumb fracture; thumb was very sore; back was sore; felt so sick; My right thumb was very sore and I could not move my left shoulder or arm.; temperature was high; felt terrible; pale; pain; I had bruises all over my shins, knees, right elbowand 2 bumps on my head; headache; chills; no idea when I will fully heal, or when I will be able to get back to normal activities; Concussion; imbalance in my inner ear from the fall and from the bangs I received on my head; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 10Feb2021 at 09:30 as a single dose for COVID-19 immunization. The patient's medical history included an unspecified immune system disorder from an unknown date and unknown if ongoing. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 20Jan2021 after her Remicaide infusion. The patient's concomitant medications were not reported. The patient experienced loss of consciousness on 11Feb2021, fall on 11Feb2021, joint dislocation on 11Feb2021, thumb fracture on 11Feb2021, concussion on an unspecified date in Feb2021, dizzy spells beginning on 13Feb2021, headache on 10Feb2021, chills on an unspecified date in Feb2021, fever on 11Feb2021, being unwell on 11Feb2021, being pale on 11Feb2021, pain beginning on 11Feb2021, contusions on 11Feb2021, decreased appetite on 14Feb2021, nausea on 14Feb2021, back pain on an 11Fev2021, sickness on 11Feb2021, pain in arm on 11Feb2021, memory deficit on 11Feb2021, weakness on 11Feb2021, balance difficulty on 13Feb2021, had no energy on 14Feb2021, being shaky beginning on 12Feb2021, whiplash injury on 11Feb2021, lethargic on 17Feb2021, inner ear disorder in Feb2021 and ADL impaired in Feb2021. Event descriptions were provided in the following first person account which was provided by reporter (the patient): ""This is a chronological record of my experience after the Pfizer Vaccine 20Jan2021, I received my first shot of the Pfizer vaccine after my Remicade infusion in (hospital name) Wednesday, 10Feb2021, I received my second shot of the Pfizer vaccine at 9:30am at (hospital name). I started getting a headache before I went to bed at around 8pm. During the night, I got a severe headache and very bad chills. So bad my teeth were rattling and I had to pull an extra blanket over me. Thursday, 11Feb2021, I got up at 7.08am. I went into the bathroom and washed my face. I was very pale and I felt terrible. I went downstairs to the kitchen. I put the kettle on and took my temperature. I had three doctor appointments that morning in and I was worried I would not be able to get into them if my temperature was high. It was 100.1. I went into the ground floor bathroom. I left the bathroom when I heard the kettle was fully boiled. The next thing I remember was the feel of carpet on my left cheek. I knew the only floor in my house that had carpet, was the basement floor. I opened my eyes and to my horror, I was able to see the basement storage room. I had no recollection on how I got there. I knew straight away, that I had fainted or passed out, on the stairs landing and had fallen down the whole flight of stairs. I was afraid to move because I didn't know if I had broken my back or my neck. I was home alone. After laying there for a few minutes, I knew I had to try to get back up the stairs so I could get to a phone. If I didn't, I knew my husband would not find me there, until after 2:30pm. I tried to get up. I struggled but I got to my knees. The next thing I recall is waking up again on the carpeted floor. This time I was sprawled out in the opposite direction, this time my head was near the thread mill. I had obviously passed out again. Now this really frightened me, I was terrified to stand up in case I fell back down again. I literally crawled up the stairs on my hands and knees. I grabbed my cell phone and called my husband to come home from work. I made that call at 7.34am. I didn't move from the sofa until he came home. He made me a cup of tea. He then brought me into the bathroom to wash my teeth. When I was finished washing my teeth, I passed out again. I woke up this time to my husband tapping my face and calling my name. I had fainted again; he had caught me and had carried me into the sofa. I was unable to sit or stand up by myself. I was so weak. I felt so sick, I couldn't even drink the tea. My husband brought me up to bed. He checked on me every hour. I came back downstairs at 4pm. I hurt all over. I had bruises all over my shins, knees, right elbow and 2 bumps on my head. My back was sore. My right thumb was very sore and I couldn't move my left shoulder or arm. I put ice on my shoulder and thumb all night. I took Tylenol pm to help me sleep. Friday, 12Feb2021, my husband helped me to get dressed. I came down the stairs with him. I was very weak. I was shaky and did not trust myself to walk down the stairs. He was having knee surgery that morning. His friend took him to the hospital as I was not fit to drive. I did not move from the sofa until he came home at around 2pm. We talked about going to the ER but I really didn't want to go because of Covid. I was not steady on my feet and I would have to be dropped outside the hospital on my own. I took pain killers all day and iced down my left shoulder and right thumb. Saturday, 13Feb2021: I was still in a lot of pain and my head was a little dizzy, especially when I lay down. I went to Urgent care at 9am. I was seen by Dr. (Name provided). She sent me for 4 x rays and took my blood. My back and right shin were x rayed, I had no broken bones. My shins and knees were badly bruised. The other 2 x rays showed I had a fracture on my right thumb and there was something wrong with my left shoulder. She suggested I go to see an orthopedic doctor on Monday. I forgot to tell her about the dizzy spells and my neck been sore. She did not examine my head or neck. She found no other reason for my fainting, except that I got the Pfizer vaccine the day before. Sunday, 14Feb2021, I continued with the pain killers and ice on my shoulder and thumb. I continued to have dizzy spells. I also felt unbalanced. My appetite was gone and I felt nauseous sometimes when I was eating. I had no energy and I hurt all over. Monday, 15Feb2021, I got an appointment with an Orthopedist at 4.30pm. My husband dropped me off. Nurse and his assistant looked after me before I saw the doctor. I was told I have a separated bone in my left shoulder. It's called acromioclavicular joint separation. AC (collar bone) separates from the scapula (shoulder blade). So, I will have to wear a sling for a few weeks. I will also have to wear a temporary cast on my right hand for a few weeks to heal the fracture on my right thumb. No surgery is needed for either. They also put me on steroids for 2 weeks, Prednisone. Tuesday 16Feb2021, I rested all day. I was still having dizzy spells and I felt off balanced & very shaky. My husband, a close friend and a coworker thought I may have a concussion and advised me to get it checked out. I spent all day on the phone trying to get an appointment with a neurologist. I did get an appointment for the next day. Wednesday 17Feb2021, I still felt the same dizziness and I was lethargic. I had an appointment with the neurologist, Dr. (Name provided) at 2pm. I had a CAT scan and it was normal, no bleeding. The doctor said I had whiplash and a concussion. He did not find any other reason for my fainting, except for the side effects of the Pfizer vaccine. He told me, I just have to rest and the symptom from the concussion should subside in a few weeks. Wednesday 24Feb2021. The Dr.'s nurse called to see how I was. I told her there was not much improvement and that I was still having dizzy spells. She called me back after she related everything to the doctor He is concerned and wants to see me again on Monday 01Mar2021. He may do an MRI to see if there is anything else going on, other than the concussion. Friday 26Feb2021. I am still having dizzy spells. Monday 01Mar2021. I had another appointment with the neurologist at 9:30 am. I need to stay off work for another week and he will re-access me again next Monday. He says I have an imbalance in my inner ear from the fall and from the bangs I received on my head. He demonstrated some EPLEY exercise, that he wants me to do. The dizzy spells have not improved. I don't feel well at all. I cannot complete house hold tasks. I still cannot drive. I can'' go to work. I have used over 40 hours of sick leave already. Now I have to be off work for another week and probably longer. I am worried and I have no idea when I will fully heal, or when I will be able to get back to normal activities. Prior to getting the vaccine, I was an ardent runner. I exercised every day and exercise is very important to me. I don't know how long it will be before I can go back to work or back to my exercise routine. I would never be in this situation, if I had not taken the Pfizer vaccine. I feel I was overdosed. I think one shot of the Pfizer vaccine would have been sufficient. I just went through 12 months without getting Covid. My immune system is suppressed so I am seriously careful about picking up germs. I have been using sanitizer wipes and hand gel for years because of my immune system being suppressed. Long before the whole world heard about Covid, I was acutely aware of germs & viruses in public places. I am so sorry now that I got this Pfizer vaccine. I think I could have gone on living for the rest of my life, without catching Covid, because I am so careful. If I had to do it all again, I would not get this vaccine. The research was not completed. The trials were not long enough. The trails were conducted in a controlled setting. They do not know all the side effects. They do not know the extent of the adverse effect on anybody, never mind somebody with my suppressed immune system. They said the side effects could be chills, fever, flu symptoms, tiredness, joint pain, muscle pain and headache. Nobody told me I might pass out or faint. Nobody warned me. If I had known fainting was a possibility, I would not have been home on my own. The word needs to get out about this side effect. The media needs to know. The public needs to know. I do not want this to happen to anybody else. Since this happened to me, I heard or someone else, that also fainted. These vaccines need more research period."" The patient underwent lab tests and procedures which included unspecified blood test on 13Feb2021 with unknown results, body temperature of 100.1 on 11Feb2021, computerised tomogram: normal on 17Feb2021, X-ray on 13Feb2021 had no broken bones but otherwise with unknown results. The clinical outcome of loss of consciousness, fall, joint dislocation, thumb fracture, concussion, dizzy spells, headache, chills, fever, being unwell, being pale, pain, contusions, decreased appetite, nausea, back pain, sickness, pain in arm, memory deficit, weakness, balance difficulty, fatigue, shaky, whiplash injury, lethargic, inner ear disorder and ADL impaired were unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/10/2021,02/01/2021,,UNK,,,Medical History/Concurrent Conditions: Immune system disorder,,,"['Asthenia', 'Back pain', 'Balance disorder', 'Blood test', 'Body temperature', 'Chills', 'Computerised tomogram', 'Concussion', 'Contusion', 'Decreased appetite', 'Dizziness', 'Fall', 'Fatigue', 'Hand fracture', 'Headache', 'Illness', 'Inner ear disorder', 'Joint dislocation', 'Lethargy', 'Loss of consciousness', 'Loss of personal independence in daily activities', 'Malaise', 'Memory impairment', 'Nausea', 'Pain', 'Pain in extremity', 'Pallor', 'Post-traumatic neck syndrome', 'Pyrexia', 'Tremor', 'X-ray']",2,PFIZER\BIONTECH, 1106333,CA,,F,"pneumonia; This is a spontaneous report from a Pfizer-sponsored program, A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 31Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date. The patient was currently taking antibiotics for pneumonia, almost done with the treatment. The patient was scheduled to get her second COVID-19 vaccination tomorrow (at the time of report) and asked if it was safe for her to do so. The outcome of the event was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/31/2021,,,UNK,,,,,,['Pneumonia'],1,PFIZER\BIONTECH, 1106337,FL,65.0,M,"prostate cancer; This is a spontaneous report from a contactable consumer reporting for himself. A 65-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on an unspecified date, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced prostate cancer (medically significant) on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of the event and included treatment with Lasix (not clarified over the call, reported as for his urine). Patient reported he had to underwent a surgery. The information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,PVT,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,['Prostate cancer'],1,PFIZER\BIONTECH, 1106339,VA,,M,"heart flutters; This is a spontaneous report from a Pfizer Sponsored, a contactable Nurse. A male patient of an unspecified age receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 24Feb2021 at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine information included BNT162B2 on 03Feb2021 was the first dose. The patient experienced heart flutters, several times a day from an unspecified date. She is wondering if this is a normal reaction and what she should do about it. Outcome of the event was unknown. Information on Lot/Batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/24/2021,,,UNK,,,,,,['Cardiac flutter'],2,PFIZER\BIONTECH, 1106341,MS,91.0,F,"Very serious bacterial urinary tract infection; Rash; on face, underneath nose and underneath chin, aggravating rash; Bacterial infection; This is a spontaneous report from a contactable consumer (the patient). A 91-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration on 26Feb2021 (at the age of 91-years) as a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW), via an unspecified route of administration on unknown date as a single dose for COVID-19 immunization. The patient reported that she got her second COVID-19 vaccine Friday, and she has gotten a rash. It is just on her face, underneath her nose and underneath her chin. It is aggravating rash. She does not know what it is. She does not know what it could be or something else. The patient also reported ""I had a very serious bacterial urinary tract infection, bacterial infection"". The patient did not have any treatment for the rash. The clinical outcome of the events very serious bacterial urinary tract infection, Rash; on face, underneath nose and underneath chin, aggravating rash, and Bacterial infection was unknown.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/26/2021,02/01/2021,,UNK,,,Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None,,,"['Bacterial infection', 'Investigation', 'Rash', 'Urinary tract infection bacterial']",2,PFIZER\BIONTECH, 1106344,,,M,"AFIB; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2, dose 1 via an unspecified route of administration on 01Feb2021 (Batch/Lot number was not reported) at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced AFIB in Feb2021 with outcome of unknown. The patient was hospitalized for event in Feb2021 to an unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/01/2021,02/01/2021,0.0,UNK,,,,,,['Atrial fibrillation'],1,PFIZER\BIONTECH, 1106345,,,U,"Patient was hospitalized for dysphasia after receiving 2nd dose of Pfizer COVID-19 vaccine.; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), second dose via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was hospitalized for dysphasia after receiving 2nd dose of Pfizer covid-19 vaccine. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,,,,['Aphasia'],2,PFIZER\BIONTECH, 1106347,,,F,"positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable Other Health Professional and a contactable consumer (patient). A 58-year-old female patient received both doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/batch number and Expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no event from vaccine. She tested positive for Covid after receiving vaccine and had another test performed that came back negative. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to event tested positive for Covid after receiving cannot be excluded based on temporal association and limited information.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,,,,"['Asymptomatic COVID-19', 'COVID-19', 'Drug ineffective', 'Investigation']",2,PFIZER\BIONTECH, 1106348,CA,78.0,F,"Pancytopenia; This is a spontaneous report from a contactable Physician. A 78-year-old female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly at Left arm on 24Feb2021 (at the age of 78-year-old) for COVID-19 immunization at the Hospital. The patient medical history included Non-Hodgkin's lymphoma. Concomitant medications were none. The patient had received the first dose of vaccine on unknown date. The patient had not known allergies. The patient was not pregnant. Patient has not tested positive for COVID-19 since having the vaccine. Patient had not a COVID-19 prior vaccination. On 01Mar2021 the patient experienced pancytopenia. The outcome was reported as not recovered. No treatment received. The event was assessed as serious Life threatening Information on Lot/Batch has been requested.; Sender's Comments: Reported life threatening pancytopenia is considered unrelated to BNT162b2 but more likely associated with patient's medical history of Non-Hodgkin's lymphoma. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/24/2021,03/01/2021,5.0,PVT,,,Medical History/Concurrent Conditions: Non-Hodgkin's lymphoma,,,['Pancytopenia'],2,PFIZER\BIONTECH,OT 1106349,,,F,"Resulted in the death; This is a spontaneous report from a Pfizer sponsored program: A contactable consumer reporting on behalf of the sister reported that a female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced an adverse effect that resulted in death on an unspecified date. Cause of death was unknown. It was unknown if an autopsy was done. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Resulted in the death",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,['Death'],UNK,PFIZER\BIONTECH, 1106350,MA,46.0,F,"First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat closing; throat closing; This is a spontaneous report from a contactable consumer (Patient herself). A 46-Year-Old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration at Left arm on 16Feb2021 17:45 (at age of 46 years old) at single dose for COVID-19 immunisation. Relevant medical history included: Athsma-lasting trouble breathing after allergic reaction, Ehlers-Danlos Syndrome, PCOS (Polycystic ovarian syndrome), Hypothyroid. Known allergies was Cashews, pistachios, cat dander. The patient's concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination. The patient experienced first dizziness and nausea Then itching Then tongue swelling/throat closing, all Adverse events started on 16Feb2021 17:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included COVID test type post vaccination was Nasal Swab, COVID test name post vaccination=PCR on 21Feb2021 with result Negative. Treatment (Epipen, IV Benadryl, Pepcid, Prednisone) received for all AE. The outcome of the events was recovered in 2021.",Not Reported,,Yes,Not Reported,,Not Reported,N,02/16/2021,02/16/2021,0.0,PUB,,,Medical History/Concurrent Conditions: Allergy; Allergy to nuts; Asthma; Ehlers-Danlos syndrome; Hypothyroidism; Polycystic ovarian syndrome,,,"['Dizziness', 'Nausea', 'Pruritus', 'SARS-CoV-2 test', 'Swollen tongue', 'Throat tightness']",1,PFIZER\BIONTECH, 1106352,MI,,F,"Received first dose and got covid and wants to cancel her second dose; Received first dose and got covid and wants to cancel her second dose; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration, on an unspecified date (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included ongoing cancer. Concomitant medications were not reported. The patient received first dose and got COVID and wants to cancel her second dose. The patient also had an infusion the day before reporting and is a cancer patient. The outcome of the events was unknown. Information on the lot/batch number has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,Cancer,,,,"['COVID-19', 'Drug ineffective']",1,PFIZER\BIONTECH, 1106554,LA,60.0,F,"She received vaccine on 12.28.21. On 12.30.21 she went to the ER and was subsequently sent to Hospital. Not sure what the findings were, but she was discharged after several hours. I spoke with her on the phone on 1.1.21,, She wasn't feeling well. I asked her what was going on because she had been doing really well for a few months. She stated ""Every since I took the vaccine, I have felt really bad."" She died on 1.5.21. Timeline: 12.28.20 Vaccine 12.30.20 ER 1.1.21 Continues to feel bad and reports feeling worse and worse since vaccine. 1.5.21 Died at home.",Yes,01/05/2021,Not Reported,Not Reported,,Not Reported,N,12/28/2020,12/28/2020,0.0,OTH,unknown,See chronic,Primary Pulmonary HTN Diabetes Chronic Renal Failure - Dialysis,,unknown,"['Death', 'Malaise']",1,MODERNA, 1106581,MO,56.0,F,"Patient was discovered deceased in her apartment at 3pm on March 12, 2021.",Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,03/10/2021,03/12/2021,2.0,PHM,unknown,"released from hospital one week prior , due to low potassium levels",unknown,,No known drug allergies,['Death'],2,MODERNA,IM 1106603,FL,100.0,M,"100 year old patient in reasonable health (reading, socializing, doing Zoom calls, etc.) took second Pfizer vaccine on February 5, 2021. On the morning of February 22, 2021 the patient suffered a major hemorrhagic stroke. He suffered severe paralysis, could not speak, and suffered from severe pain. Within 24 hours he was moved to Hospice Care. A day later on February 24, 2021 he died.",Yes,02/24/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/22/2021,17.0,SEN,,,,,,"['Aphasia', 'Death', 'Haemorrhagic stroke', 'Pain', 'Paralysis']",2,PFIZER\BIONTECH,SYR 1106667,CA,67.0,M,"Information here obtained from daughter: on Thursday patient had an uneventful fistulagram with angioplasty. Patient got vaccine at end of usual Friday am dialysis treatment. He was observed for about 30"" and no untoward event noted, vitals usual. At home on Saturday morning, seemed not quite himself by wife as reported by daughter, from whom i got his information. He gets up late as hemodialysis starts at 515 am. No reported problems on Friday. On Saturday morning, he seemed not himself but sat down and ate breakfast around 9 am. On getting up from table he got suddenly weak, his head rolled back and his eyes rolled up. 911 called and he was given resuscitation efforts of unknown duration which were unsuccessful. He was pronounced dead at 11 am and the mortuary was called. No premortem labs, et al.",Yes,03/13/2021,Not Reported,Not Reported,,Not Reported,U,03/12/2021,03/13/2021,1.0,OTH,"amlodipine 5 mg daily, carvedilol 12.5 mg twice daily, furosemide 80 mg twice daily, sevelamer 800 mg 2 with meals tid, terazosin 2 mg daily, pantoprazole 20 mg daily if needed for heartburn, cinacalcet 30 mg daily","DM 2 with ESRD, hyperlipidemia, vascular disease, autonomic neuropathy, retinopathy, CAD w hx of CABG and coronary artery stent, chondrocalcinosis, gout. also hx of covid disease 6/3/2020. anemia renal disease, hyperparathyroidism of renal failure. hx smoking. hx stroke and TIAs; hx of subdural hematoma .",see above.,,penicillin,"['Asthenia', 'Death', 'Eye movement disorder', 'Feeling abnormal', 'Resuscitation']",1,MODERNA,IM 1106684,HI,86.0,M,Resident on palliative/comfort care services since readmission to facility on 2/9/2021. Received first dose of Moderna COVID-19 vaccine on 1/7/2021. Received second dose of Moderna COVID-19 vaccine on 3/8/21. G-tube feeding discontinued on 2/14/21. Resident expired 3/10/2021.,Yes,03/10/2021,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/10/2021,2.0,SEN,"Promethazine, Fentanyl patch","R ankle ulcer, R heel pressure injury, hyperkalemia, CHF","PVD with chronic Right ankle ulcer, PVD with R heel pressure injury, dysphagia following CVA, oropharyngeal dysphagia, AFib, HTN, CAD, Acute on Chronic diastolic heart failure, RT hemaplegia following CVA, Aphasia following CVA, hemaplegia following CVA, Acute kidney failure, hyperkalemia, hypernatremia, adult failure to thrive, blood loss anemia, gout, presence of AICD, history of cardiac arrest, G-tube feeding (G-tube feeding discontinued on 2/14/21, G-tube dislodged 3/8/21)",,"Cephalexin, Ciprofloxacin, Clindamycin, Lisinopril, Losartan, Shellfish, Shilvadene, Toradol, Vitamin E, Latex",['Death'],2,MODERNA,SYR 1106719,CO,59.0,F,Her daughter informed pharmacy staff that pt passed away on sunday 3/14/21,Yes,03/14/2021,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/14/2021,5.0,PHM,,,"kidney chronic disease , diabetes",,,['Death'],1,MODERNA,IM 1106733,HI,94.0,F,"First dose of Moderna COVID-19 vaccine given 1/7/21. Second dose of Moderna COVID-19 vaccine given 3/8/21. No adverse effects noted after vaccination. Resident was on hospice care since 2/27/2021 with poor food and fluid intake prior. Admitted to hospice with hypokalemia, failure to thrive.",Yes,03/14/2021,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/14/2021,6.0,SEN,"Potassium chloride, timolol maleate 0.5%, latanoprost 0.0005%",R upper lobe PNA,"PNA, Afib with rapid response, Senile Dementia without behavioral disturbances, Hypertension, History of fall, Glaucoma, Mild protein-calorie malnutrition, lumbar degenerative disc disease, Hyperlipidemia, Hx of esophageal polyps, Dysphagia and Hiatal Hernia",,Aspirin,"['Failure to thrive', 'Hypokalaemia']",2,MODERNA,SYR 1106737,WA,82.0,M,"weakness/malaise per daughter, death on 3/14 (did have underlying medical conditions)",Yes,03/14/2021,Not Reported,Not Reported,,Not Reported,N,03/11/2021,03/14/2021,3.0,PVT,"melatonin, calcium, vitamin D, famotidine, quetiapine 50 mg QHS",Normal pressure hydrocephalus -- s/p VP shunt with dementia,"BPH, C-spine fracture with myelopathy, GERD",,"opiates, pencillins (hives)","['Asthenia', 'Death', 'Malaise']",1,JANSSEN,IM 1106834,NE,70.0,M,"Patient apparently expired 3/09/2021, no other information known, unknown if linked.",Yes,03/09/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/09/2021,4.0,PUB,"""ASA"" was noted on pre-screen; patient apparently also on oxygen per friend and POD staff due to COPD",COPD; recently began oxygen therapy,COPD; unknown others,,None reported on prescreen,['Death'],1,MODERNA,IM 1108263,,78.0,M,"Death Narrative: Patient died at home on 2/11/21, two days after receipt of the Pfizer COVID19 vaccine. Reviewed death certificate and cause of death is listed as chronic systolic heart failure and pulmonary hypertension. That is all the information that I have.",Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,N,02/09/2021,02/11/2021,2.0,OTH,,,,,,"['Chronic left ventricular failure', 'Condition aggravated', 'Death', 'Pulmonary hypertension']",UNK,PFIZER\BIONTECH, 1108264,,85.0,M,DEATH Narrative: No information available in the record other than date of vaccine on 1/7/2021 with no adverse effects or complications noted during observation period. Patient was not known to have had COVID infection prior to death. Had last received medical care at facility in 2012 except received audiology care up to 12/2/2020. No recent hospitalizations known. No death note or autopsy noted. Only indication of death is the updated banner/date of death in demographics. Death most likely due to advanced age (84 y/o) in addition to comorbidities.,Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,02/23/2021,47.0,OTH,,,,,,['Death'],1,MODERNA,IM 1108473,,,U,death Narrative: Patient received 1st dose of Moderna COVID-19 vaccine on 03/08/2021. Patient died 03/09/2021. Medical examiner received report that patient was alert before a fall on the night of 03/08/2021. Death certificate will report death likely due to arrhythmia due to underlying CHF. Contributing factors include diabetes.,Yes,03/08/2021,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Arrhythmia', 'Cardiac failure congestive', 'Condition aggravated', 'Death', 'Diabetes mellitus', 'Fall']",UNK,PFIZER\BIONTECH, 1108474,,,M,"death Narrative: Patient was admitted to the ER on 12/26/20 with worsening shortness of breath and was admitted to acute care services. On 12/29/20, a hospice consult was placed for end stage CHF, EF 20%. On 12/30/20, he transferred to the facility and was a DNR. On 1/7/21, he was noted to have increased secretions in throat and was given atropine gtts sublingual and ondansetron for nausea. He also had issues with insomnia and was given trials of hydroxyzine, trazodone and melatonin. Lorazepam remained on profile as well as part of hospice care. On 1/9/21, he was noted to be more confused, tachypneic and had anasarca (furosemide was ordered). Later on that same day he began to decline rapidly to the point of unresponsiveness other than to verbal stimuli and was determined to be imminent. On 1/10/21, he remained unresponsive and not able to tolerate oral meds. That same day at 1020 when nursing did rounds, he was found to be pulseless and without respirations. An autopsy was declined.",Yes,01/10/2021,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,,,,"['Cardiac failure', 'Cardiac failure congestive', 'Confusional state', 'Death', 'Dyspnoea', 'General physical health deterioration', 'Generalised oedema', 'Increased upper airway secretion', 'Insomnia', 'Nausea', 'Pulse absent', 'Respiratory arrest', 'Tachypnoea', 'Unresponsive to stimuli']",UNK,UNKNOWN MANUFACTURER, 1107179,NV,81.0,F,"Her doctor said she may have possible leukemia; Soreness; Redness the size of a quarter, Redness was 2 inches round, Redness is 4.5 inches in length and 3.5 inches in width; Pain at the injection site, couldn't sleep, every time I turned, it was painful; Rash; Pain at the injection site, couldn't sleep, every time I turned, it was painful; Terrible pain on her arm; A spontaneous report was received from a consumer who was also a 81-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced soreness, pain at the injection site, couldn't sleep, vaccination site pain, redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width. Patient's doctor suspecting leukemia. The patient's medical history included COVID 19 infection on 13 Oct 2020. Products known to have been used by the patient, within two weeks prior to the event, included hydroxyurea nonspecific. On 13 Feb 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 031M20A) intramuscularly in the Left Deltoid for prophylaxis of COVID-19 infection. On 13 Feb 2021 at night 11pm, patient began to feel pain at the injection site. Patient reported that patient couldn't sleep all of Saturday night, every time patient turned, it was painful. By Monday, the pain turned into just soreness, however, patient developed redness the size of a quarter at the injection site. Two days before reporting, the redness was 2 inches round and currently the redness is 4.5 inches in length and 3.5 inches in width, which indicates that it was spreading. Patient reached out to patient's doctor. Patient also reported some itching at the injection site last night. The patient also reported Rash, terrible pain on arm, and COVID-arm reaction. Patient's also reported that her doctor is suspecting a leukemia. Treatment for the event included ice on the area 3 times a day, 15 minutes at a time. Action taken with mRNA-1273 in response to the events was not provided. The events, soreness, pain at the injection site, couldn't sleep, every time turned, it was painful, COVID arm reaction, terrible pain on her arm, redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width, rash, were considered recovered on an unspecified date and The outcome of the event leukemia is unknown. Addition information Additional information received on 01 Mar 2021 included outcome of the events , pain at the injection site, couldn't sleep, every time turned, it was painful, COVID arm reaction, terrible pain on her arm, redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width, rash and reported patient was suspecting leukemia.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/13/2021,02/13/2021,0.0,UNK,HYDROXYUREA,,Medical History/Concurrent Conditions: COVID-19 (Had only mild symptoms (sore throat and mild cough).),,,"['Erythema', 'Insomnia', 'Leukaemia', 'Musculoskeletal stiffness', 'Pain in extremity', 'Rash', 'Vaccination site pain']",1,MODERNA,OT 1107184,MI,73.0,F,"temperature 109 F; dizzy; she feels nauseous; arm is hurting; A spontaneous report was received from a consumer concerning a 73-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced the events body temperature 109F, she feels nauseous, arm is hurting, dizzy. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03 Feb 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) for prophylaxis of COVID-19 infection. On 03-FEB-2021 the patient experienced the events body temperature 109F (medically significant), she feels nauseous, arm is hurting, dizzy. Treatment information included paracetamol (Tylenol). Laboratory data included body temperature which was 109 F. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events body temperature 109F, she feels nauseous, arm is hurting, dizzy was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/03/2021,02/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Body temperature', 'Dizziness', 'Hyperpyrexia', 'Nausea', 'Vaccination site pain']",1,MODERNA,OT 1107187,OH,89.0,F,"Blood clots on her legs; Blood clots on her lungs; A spontaneous report was received from a consumer concerning 89-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced blood clots on legs and lungs. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 05 Feb 2021, approximately 7 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route in the right arm for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient was hospitalized for blood clots on legs and lungs for 7 days and was discharged on 17 Feb 2021. Treatment include unknown injections. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was not reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested",Not Reported,,Not Reported,Yes,,Not Reported,U,02/05/2021,02/11/2021,6.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Deep vein thrombosis', 'Pulmonary embolism']",1,MODERNA,OT 1107188,MO,,F,"death after second dose; A spontaneous report was received from a consumer concerning a female patient of unknown age, who experienced severe symptoms post first dose of Moderna's Covid-19 vaccine (mRNA-1273) and death shortly after her second dose. The patient's medical history was not provided. Concomitant medication was not provided by the reporter. No lab data was not provided On unspecified date, the patient received her second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. It was reported that shortly after receiving the second dose of mRNA-1273, the patient died. Treatment information was not provided/unknown. Action taken with the drug in response to the events is not applicable. The patient died on an unknown date. Plans for an autopsy were not reported; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: death",Yes,,Not Reported,Not Reported,,Not Reported,N,,,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,['Death'],1,MODERNA,OT 1107190,NC,34.0,F,"Vision loss; Balance issues; Tingling in Extremities; Fatigue; Chills; A spontaneous report was received from a consumer concerning a 34-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vision loss, tingling in extremities, paraesthesia, balance issues, fatigue and chills. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) on an unspecified date in Jan 2021 intramuscularly. On 12-Feb-2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of Covid-19 infection. On 13 Feb 2021, Patient experiencedvision loss, tingling in extremities, paraesthesia, balance issues, fatigue and chills. Laboratory details included an increased white blood cell count..Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events. Therefore, action taken with the drug in response to the events is not applicable. The outcomes of the events of vision loss, tingling in extremities, balance issues, fatigue, and chills were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/01/2021,02/13/2021,43.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Balance disorder', 'Blindness', 'Chills', 'Fatigue', 'Paraesthesia', 'White blood cell count']",1,MODERNA,OT 1107192,CA,71.0,M,"fainting spells or passing out; severe stomach pain, abdominal pain; nausea; Swollen lymph nodes in three places like a triangle; low blood pressure with faint pulse; faint heart beat or rate with flutters; lightheadedness; blurry vision; right ear ache; face flush or red face; burning sensation on his hands; red rash on under arm; HEART FLUTTER; A spontaneous report was received from a Consumer concerning himself as a 72 Years-old male elder patient who experienced severe stomach pain, nausea, abdominal pain, swollen lymph node in three places like a triangle, low blood pressure with a faint pulse, faint heartbeat or rate with flutters, dizziness, lightheadedness, fainting spells or passing out, blurry vision, right earaches, facial flushness or red face, burning sensation on his hand and red rash on his under arm. The patient's medical history was low glycemia and atrial arrhythmia.His concomitant medications were reported as Vitamin D31000 IU as supplement, Prevacid 30 for acid reflux prevention and Magnesium 400mg as supplement. On 15 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced fainting spells which is medically significant and the other events are severe stomach pain, nausea, abdominal pain, swollen lymph node in three places like a triangle, low blood pressure with a faint pulse, faint heartbeat or rate with flutters, dizziness, lightheadedness, blurry vision, right earaches, facial flushness or red face, burning sensation on his hand and red rash on his under arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was Unknown. The outcome of the event(s) severe stomach pain, nausea, abdominal pain, swollen lymph node in three places like a triangle, low blood pressure with a faint pulse, faint heartbeat or rate with flutters, dizziness, lightheadedness, fainting spells or passing out, blurry vision, right earaches, facial flushness or red face, burning sensation on his hand, red rash on his under arm were Unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/15/2021,,,UNK,VITAMIN D3 1000; PREVACID; MAGNESIUM 400,,Medical History/Concurrent Conditions: Atrial fibrillation; Hypoglycemia,,,"['Abdominal pain upper', 'Burning sensation', 'Cardiac flutter', 'Dizziness', 'Ear pain', 'Erythema', 'Hypotension', 'Lymphadenopathy', 'Nausea', 'Pulse abnormal', 'Rash erythematous', 'Syncope', 'Vision blurred']",1,MODERNA,OT 1107194,NY,71.0,F,"Bad Rheumatoid Arthritis flare up; sore arm; chills; fever; fatigue; A spontaneous report was received from a consumer concerning a 71-years-old who received Moderna COVID-19 vaccine (mRNA-1273) and experienced rheumatoid arthritis flare up, sore arm, chills, fever, and fatigue. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included prednisone, tofacitinib citrate, folic acid, sertraline, ropinirole, clonazepam, gabapentin, and nortriptyline. On 04 Mar 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 027A21A) intramuscularly for prophylaxis of COVID-19 infection. On 04-Mar-2021, the patient experienced chills, fever, fatigue, sore arm, and a bad rheumatoid arthritis flare up all since 04 Mar 2021. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event chills, fever, fatigue, sore arm, and a bad rheumatoid arthritis flare up were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/04/2021,03/04/2021,0.0,UNK,PREDNISONE; XELJANZ; FOLIC ACID; SERTRALINE; ROPINIROLE; CLONAZEPAM; GABAPENTIN; NORTRIPTYLINE,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Chills', 'Fatigue', 'Pyrexia', 'Rheumatoid arthritis', 'Vaccination site pain']",1,MODERNA,OT 1107200,,,M,"tunnel vision; dizziness; headache in different regions; A spontaneous report received from a consumer concerning a 47-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, tunnel vision, and headache in different regions. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Feb 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (batch number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection. On 02 Mar 2021, the patient experienced dizziness, had tunnel vision and headache in different regions. Went to the ER. Treatment information was unknown. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events,Tunnel vision, dizziness and headache in different regions, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/27/2021,03/02/2021,3.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Dizziness', 'Headache', 'Tunnel vision']",1,MODERNA,OT 1107201,WA,,F,"left eye had burst blood vessels; bruise on the injection site; temperature was higher by one or two degrees; tired; cough; voice went out; throat was rough; voice keeps going in and out; headache; A spontaneous report received from a consumer, who was also a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cough, voice went out (aphonia), throat was rough (oropharyngeal discomfort), voice keeps going in and out (dysphonia), headache, tired (fatigue), left eye had burst blood vessels (eye haemorrhage), body temperature was higher by one or two degrees (body temperature increased),and bruise on the injection site (injection site bruise). The patient's medical history was not provided. Concomitant medications included an unspecified thyroid medication. On 01 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, the patient experienced cough. her voice went out like her throat was rough. Her voice kept going in and out. That night, she had a headache. On 02 Mar 2021, the patient felt tired, still had headaches, and her temperature was higher by one or two degrees. On 03 Mar 2021, the patient woke up and her left eye had burst blood vessels. She also had a bruise on the injection site on left, non-dominant arm. Treatment for the events included paracetamol. Action taken with mRNA-1273 in response to the events was unknown. The events of cough and voice went out like her throat was rough were considered resolved on 01 Mar 2021. The outcome of the events of voice keeps going in and out, tired, left eye had burst blood vessels, headache, bruise on the injection site was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/01/2021,03/01/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Aphonia', 'Body temperature', 'Body temperature increased', 'Cough', 'Dysphonia', 'Eye haemorrhage', 'Fatigue', 'Headache', 'Injection site bruising', 'Oropharyngeal discomfort']",1,MODERNA,OT 1107202,NJ,,F,"Migraines have became more frequent and more intense to the point of were she could not function; Developed a welt at the injection site that she describes as COVID arm which was a 3-4inch raised circle underneath the injection site; Pain under lymph nodes; Developed thrombosis on her head, but it went away; A spontaneous report was received from a consumer on 04 Mar 2021 concerning a 45-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed thrombosis on her head, but it went away, migraines have become more frequent and more intense to the point of were she could not function, developed a welt at the injection site that she describes as COVID arm which was a 3-4inch raised circle underneath the injection site, lymph nodes pain, which she still has. The patient's medical history was not reported. Current conditions included migraine. The patinet had allergy to latex and pineapple. No relevant concomitant medications were reported On 14 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot: not provided) intramuscularly in right arm for prophylaxis of COVID-19 infection. Since 14 Feb 2021, patient's migraines had became more frequent and more intense to the point of were she could not function. She also developed thrombosis on her head, but it went away. The patient also developed a welt at the injection site that she described as COVID arm which was a 3-4 inch raised circle underneath the injection site. She also developed pain under lymph nodes, which she still had. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The event of migraines have became more frequent and more intense to the point of were she could not function and pain under lymph nodes which she still has were unresolved, the event of developed thrombosis on her head but it went away was resolved, while the outcome of the event of developed a welt at the injection site that she describes as COVID arm which was a 3-4inch raised circle underneath the injection site was unknown. The reporter did not provide an assessment for the events thrombosis on her head, but it went away, migraines have became more frequent and more intense to the point of were she could not function, developed a welt at the injection site that she describes as COVID arm which was a 3-4inch raised circle underneath the injection site, Pain under lymph nodes, which she still has.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/14/2021,02/14/2021,0.0,UNK,,Fruit allergy; Latex allergy; Migraine,,,,"['Injection site urticaria', 'Lymph node pain', 'Migraine', 'Thrombosis']",1,MODERNA,OT 1107203,WA,,F,"Woke up with like the flu; Just sick, with body very sensitive to temperatures; Dont have the energy to do anything; Body aches; The arm hurt worst that the first one; Was hard to move the arm; A spontaneous report, was received from a consumer (patient), a 69 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced the arm hurt worst that the first one (pain in extremity), was hard to move the arm (hypokinesia), woke up with like the flu (influenza like illness), body aches (pain), just sick, with the body very sensitive to temperatures (feeling hot), and don't have the energy to do anything (asthenia). The patient's medical history was not provided. The relevant concomitant medications included blood pressure medication. On 03 Mar 2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (lot: 010A21A), intramuscularly for the prophylaxis of COVID-19 infection. On 03 Mar 2021, the patient reported feeling really horrible after the second dose. On the same day, after receiving the vaccine, the patient's arm was hurting worst that the first one and, in the evening, it was hard to move the arm. On 04 Mar 2021, the patient reported that she woke up with flu from thirty years ago and felt like a horrible flu, very bad, with body aches. The patient stated that it was just sick, with the body very sensitive to temperatures. The patient reported that she started to feel a little tiny bit better now but do not have the energy to do anything. The treatment medication included two ibuprofen on the night and two more on the morning. Action taken with second dose of mRNA-1273 in response to the events was not applicable. The outcome of the events, arm hurt worst that the first one, was hard to move the arm, woke up with like the flu, body aches, just sick, with the body very sensitive to temperatures, and don't have the energy to do anything were considered as recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/03/2021,03/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No medical history reported),,,"['Asthenia', 'Feeling hot', 'Hypokinesia', 'Influenza like illness', 'Myalgia', 'Vaccination site pain']",2,MODERNA,OT 1107204,NC,68.0,F,"Passed out; Sweats; Lightheaded; Fatigue; Chills; Nausea; Vomit; Headache; A spontaneous report was received from a consumer concerning herself, a 68 year old female patient who experienced passed out/loss of consciousness, sweats/hyperhidrosis, lightheadedness/dizziness, fatigue/fatigue, chills/chills, nauseas/nausea, vomit/vomiting, headache/headache. The patient's medical history was not provided. Concomitant product use was not provided. The patient received her first of two planned doses of mRNA-1273 on unknown date for prophylaxis of Covid-19 infection. On 01-Mar-2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (Batch number 014M20A) intramuscularly into her left arm for prophylaxis of Covid-19 infection. On 02-Mar-2021, the patient stated she ""passed out"", she also experienced sweats, lightheadedness, fatigue chills, nauseas, vomit, and headache. No other treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The events, passed out/loss of consciousness, sweats/hyperhidrosis, lightheadedness/dizziness, fatigue/fatigue, chills/chills, nauseas/nausea, vomit/vomiting, headache/headache.was considered unknown.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Fatigue, chills vomiting, headache and nausea are consistent with the known safety profile of the vaccine",Not Reported,,Not Reported,Not Reported,,Not Reported,U,03/01/2021,03/02/2021,1.0,UNK,,,Medical History/Concurrent Conditions: No adverse effect (Medical history not provided),,,"['Chills', 'Dizziness', 'Fatigue', 'Headache', 'Hyperhidrosis', 'Loss of consciousness', 'Nausea', 'Vomiting']",1,MODERNA,OT 1107205,FL,,F,"Hurting all over; Body felt like a ball on fire; Could not drink water because it kept coming back up; A spontaneous report was received from a consumer concerning a 80 year old, female patient who experienced hurting all over her body (pain), body felt like a ball on fire (feeling hot), and vomiting. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Vitamin C, Vitamin D, Echinacea, Losartan, lovastatin, baby aspirin (81 mg), metoprolol and pantoprazole. The patient received the first of two planned doses of mRNA-1273 (Batch number: 011A4N) on 27 Feb 2021. On 28 Feb 2021, the was hospitalized due to her symptoms like she was hurting all over her body like a ball on fire and vomiting. Treatment for the event included anti-inflammatory shot and acetaminophen. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/27/2021,02/28/2021,1.0,UNK,VITAMIN C ACID; VITAMIN D 2000; ECHINACEA+; LOSARTAN; LOVASTATIN; BABY ASPIRIN; METOPROLOL; PANTOPRAZOLE,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,"['Feeling hot', 'Pain', 'Vomiting']",1,MODERNA,OT 1107206,IL,86.0,M,"he could not move his hands easily, felt like paralyzed; he could not stand up; A spontaneous report was received from a consumer concerning a 86-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and he could not stand up, he could not move his hands easily and felt like paralyzed. The patient's medical history was not provided by the reporter. Concomitant medications reported included lisinopril and brimonidine tartrate/timolol maleate. On 02 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection. On 03 Mar 2021, he could not stand up, he could not move his hands easily and felt like paralyzed. Treatment for the events was not provided. Action taken with mRNA-1273 in response to the events was unknown/not reported. The outcome of the events, could not stand up, could not move his hands easily and felt like paralyzed, was considered recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Yes,N,03/02/2021,03/03/2021,1.0,UNK,LISINOPRIL; COMBIGAN,,Medical History/Concurrent Conditions: No adverse event (Medical history not reported.),,,"['Dysstasia', 'Mobility decreased']",2,MODERNA,OT 1107207,NC,71.0,F,"A single seizure; Headache; Chills; A spontaneous report was received from a consumer who is a 71 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headaches, chills, and seizure. The patient's medical history was not reported. Concomitant medicine reported included metoprolol. The patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection on unknown date. On 27 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Batch number: 014M20A] intramuscularly in the right dominant arm for prophylaxis of COVID-19 infection. On 27 Feb 2021, the patient experienced headache and chills. On the morning of 01 March 2021, patient experienced a single seizure and transported to hospital. Emergency department discharged the patient stated that her magnesium levels were low and was given magnesium supplements and advised to follow up with PCP. Later the patient followed up with her PCP and they concluded her magnesium levels were normal then. Treatment for the event included Magnesium Supplements. The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the events is not applicable. The outcome of events, headaches, chills, and seizure were resolved on 28 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/27/2021,02/27/2021,0.0,UNK,METOPROLOL,,Medical History/Concurrent Conditions: No adverse event (No medical history provided.),,,"['Blood magnesium', 'Chills', 'Headache', 'Seizure']",2,MODERNA,OT 1107208,NC,65.0,F,"Relapse of her rheumatoid arthritis; A spontaneous report was received from a consumer who was also a 65-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced relapse of her rheumatoid arthritis. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unspecified date, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection. On 02 Mar 2021, the patient received the second of two planned doses of mRNA-1273 (lot#062I70A). On an unknown date patient had relapse of patient's rheumatoid arthritis. Treatment for the event included Tylenol every 4 hours. The patient received both scheduled doses of mRNA-1273 prior to the report; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,03/03/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Rheumatoid arthritis'],1,MODERNA, 1107209,,77.0,F,"Anaphylaxis reaction; A spontaneous report was received from a consumer concerning a 77 year old, female patient who developed Anaphylaxis reaction. The patient's medical history included allergies. Concomitant product use was not provided by the reporter. Vaccination details are not provided by the reporter. After she received vaccine developed Anaphylaxis reaction. Treatment for the event included steroid shot. Now her doctor says the shot is ineffective and she can't get the second shot. She wants to know whether that information true and she is willing to take second shot despite her doctors advice. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event Anaphylaxis reaction was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: Allergy,,,['Anaphylactic reaction'],1,MODERNA, 1107210,OH,,M,"seizure; shaking; aches and pains; headache; A spontaneous report was received from a consumer concerning a 67-year-old, male patient, who experienced Seizure, aches and pain, headache, and shakes. The patient's medical history, was not provided by the reporter. No Concomitant medications were reported. On 29 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007MZ0A) in the left arm for prophylaxis of COVID-19 infection. On 26 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 006MZ0A) in the left arm for prophylaxis of COVID-19 infection. That night patient had aches/pains and a headache. The next day, on 27 Feb 2021, patient had a seizure. The patient shook so hard he came off the chair, the shaking was unbelievable.He was taken by rescue squad to the local hospital but was transferred immediately to another hospital. Patient was discharged from hospital Wednesday, 3 March 2021.Treatment for the events were not reported. Action taken with mRNA-1273 in response to the events was not applicable as patient received both the doses. The outcome of the events, were Unknown.; Reporter's Comments: The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.",Not Reported,,Not Reported,Yes,5.0,Not Reported,U,01/29/2021,02/26/2021,28.0,UNK,,,Medical History/Concurrent Conditions: No adverse event,,,"['Headache', 'Pain', 'Seizure', 'Tremor']",1,MODERNA,OT 1107211,AZ,75.0,M,"Diagnosed with cellulitis; both lower legs broke out with a rash; A spontaneous report was received from a Consumer concerning himself,75 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced both lower legs broke out with a rash(rash) and diagnosed with cellulitis(cellulitis). The patient's medical history was not provided. No relevant concomitant medications were reported. On 01 Mar 2021,approximately six hours prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (batch: 010M20A) in the right non-dominant arm for prophylaxis of COVID-19 infection. On 01 Mar 2021,the patient experienced both lower legs broke out with a rash. On 03 Mar 2021, Patient saw a physician and was diagnosed with cellulitis. The event cellulitis was medically significant. Treatment for the event included beta methasone 0.1% topical cream. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The outcome of the events, both lower legs broke out with a rash and diagnosed with cellulitis were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,,03/01/2021,,UNK,,,Medical History/Concurrent Conditions: No adverse event (no reported medical history.),,,"['Cellulitis', 'Rash']",1,MODERNA, 1107212,CA,76.0,M,"Parkinson's psychosis; Not received second dose; A spontaneous report was received from a consumer concerning a 76-years old, male patient who experienced the events Parkinson's disease psychosis and missed dose due hospitalization. The patient's medical history was not provided. Concomitant product was not reported. On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the anatomical for prophylaxis of COVID-19 infection. On 26 Feb 2021, the patient experienced the event Parkinson's psychosis and was hospitalized. The patient's second dose was scheduled on 03 Mar 2021, but he did not receive the second dose due to hospitalization. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event Parkinson's disease psychosis and missed dose were unknown.; Reporter's Comments: The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.",Not Reported,,Not Reported,Yes,,Not Reported,U,02/05/2021,02/26/2021,21.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"[""Parkinson's disease psychosis"", 'Product dose omission issue']",1,MODERNA,OT 1107213,,,F,"not feeling well; fever; threwup; Case reference number MOD-2021-036768 is a spondaneous report which refers to a Female patient. The patients relevant medical history included Covid-19. There were no concomitant medications provided. On unknown date, the patient first of two planned doses of mRNA-1273 (Batch # unknown) unknown location, for prophylaxis of COVID-19 infection. . On an unknown date, the patient experienced not feeling well, fever, and threw up. The patient went to the hospital for not feeling well and was admitted for two days. There was no treatment information provided. The action taken for Moderna COVID-19 Vaccine was not provided. The outcome for the reported events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,,Not Reported,U,,,,UNK,,,Medical History/Concurrent Conditions: COVID-19,,,"['Malaise', 'Pyrexia', 'Vomiting']",1,MODERNA,OT 1107214,MI,,F,"passed out; could not breath; twitching of foot; extremely cold; became warm; upset stomach; room began to spin; unusually tired; A Spontaneous report was received from a health care professional concerning an female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced unusually tired, extremely cold, became warm, upset stomach, room began to spin, could not breath, pass out, twitching foot. The patient's medical history, included cancer, prior radiation and chemotherapy and surgery. Concomitant product use included unspecified inhaler. On 03 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (lot number 011az1a) intramuscularly for prophylaxis of COVID-19 infection. On 03 Mar 2021, the same day of vaccination the patient was unusually tired and slept ten hours. Next day, the patient felt extreme cold and decided to take warm bath. Then within ten minutes after the bath, patient became warm, had an upset stomach, and noted the room began to spin. The patient subsequently could not breath and passed out. The patient's husband noted the patient's foot twitching, and felt that she was still alive. Per the patient's spouse, the patient was unresponsive for one minute. Once awakened, the patient took her inhaler and Benadryl. Within 30 minutes all the symptoms were gone and have not returned. The patient noted having this same type of experience during her Sep 2020 first round of chemotherapy. The patient has been cancer free for five months. Treatment information included inhaler and Benadryl. There was no change planned to the dosing schedule of mRNA-1273 in response to the events. Patient's physician stated it was okay to take the second dose. The events unusually tired, extremely cold, became warm, upset stomach, room began to spin, could not breath, passed out, and twitching foot were considered resolved on 04 Mar 2021.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,03/03/2021,03/03/2021,0.0,UNK,,,Medical History/Concurrent Conditions: Cancer (Diagnosed with cancer on dec2019 and had radiation and chemotherapy and then surgery in may 2020.); Chemotherapy; Radiotherapy; Surgery,,,"['Abdominal discomfort', 'Dizziness', 'Dyspnoea', 'Fatigue', 'Feeling cold', 'Feeling hot', 'Loss of consciousness', 'Muscle twitching']",1,MODERNA,OT 1107215,FL,,M,"Chest pains; missed dose; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hospitalization with chest pain and missed dose. The patient's medical history was not provided. No concomitant was provided. On 09 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly on his left arm for prophylaxis of COVID-19 infection. On 04/Mar/20201 patient reported that he was admitted in hospital with chest pain. Patient reports that he had no symptoms after the Moderna COVID-19, but will be unable to make his second vaccine appointment. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event:, chest pain, was considered unknown/not reported The outcome of the event, missed dose, was considered recovered/resolved on an unknown date.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Company assessed the events to be unlikely related to company product.",Not Reported,,Not Reported,Yes,,Not Reported,Y,02/09/2021,03/04/2021,23.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Chest pain', 'Product dose omission issue']",1,MODERNA,OT 1107216,NH,,F,"Rash; Redness; dizziness, headache, burning in her throat and chest, tingling in her chest, her arm felt light weight,; Hand was sore; Swelling; A report was received from a consumer concerning a 65-year-old, female patient of unknown race. Developed anaphylactic reaction and vaccine site reactions. The patient's medical history included head injury and symptoms of passing out. Concomitant medication included antibiotic (unknown name) On 26 Feb 2021, the patient received their first of two planned doses of mRNA-1273 injection (Lot number- 030L20A) via unknown route in right arm for prophylaxis of COVID-19 infection. On same day, immediately after receiving vaccination, the patient experienced dizziness, headache, burning in her throat and chest, tingling in her chest, her arm felt light weight, not responding to verbal stimuli, hard time breathing, low blood pressure. she also had her hand sore, swelling and redness. She received Epi pen couple shots (number unknown) and was taken to Emergency room, where she stayed for 4 hours and was discharged with a diagnosis of sever allergy reaction. The treatment details in ER was reported. Health care provider assessed the events as related to the combination of vaccine plus antibiotic. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the anaphylactic events were resolved. The causality assessment of the reported events was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,02/26/2021,02/26/2021,0.0,UNK,,Allergy,Medical History/Concurrent Conditions: Head injury; Passed out,,,"['Anaphylactic reaction', 'Vaccination site erythema', 'Vaccination site pain', 'Vaccination site rash', 'Vaccination site swelling']",1,MODERNA, 1107265,TN,52.0,M,"white blood cell count was very high; death; This is a spontaneous report from a contactable consumer (ex-spouse) via medical information team. A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 02Mar2021 at a single dose (at the age of 52-years-old) for COVID-19 immunisation. Medical history included back pain: At some point before the vaccine was administered, he had a telehealth visit for reported back pain. Concomitant medications were not reported. The patient died on 05Mar2021 at his home. The patient received the first dose of COVID vaccine at a hospital on 02Mar2021. The patient was a fairly healthy active 52-year-old. At some point before the vaccine was administered, he had a telehealth visit for reported back pain. He was instructed to get blood work/labs done. A letter was received the day of his death that states his white blood cell count was very high and with it a recommendation that he seek medical attention. She (ex-spouse) reports the autopsy results won't be complete for a few months. The cause of death is unknown. The outcome of white blood cell count was very high was unknown. Information on the lot/ batch number has been requested.; Reported Cause(s) of Death: Death",Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/02/2021,03/05/2021,3.0,PVT,,,"Medical History/Concurrent Conditions: Back pain (At some point before the vaccine was administered, he had a telehealth visit for reported back pain)",,,"['Blood test', 'Death', 'White blood cell count', 'White blood cell count increased']",1,PFIZER\BIONTECH, 1107445,CA,89.0,M,Site: Pain at Injection Site-Mild,Yes,02/19/2021,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/16/2021,4.0,SEN,,,,,,['Injection site pain'],2,PFIZER\BIONTECH,IM 1107648,IL,89.0,M,Developed leukemia and kidney failure. Died in 6 days.,Yes,03/13/2021,Not Reported,Yes,5.0,Not Reported,N,02/01/2021,03/08/2021,35.0,MIL,,,,,,"['Death', 'Leukaemia', 'Renal failure']",2,MODERNA, 1107656,MI,69.0,M,Patient was found dead on 3/15/2021,Yes,03/15/2021,Not Reported,Not Reported,,Not Reported,N,03/03/2021,03/15/2021,12.0,PVT,Abilify 10mg daily Bumex 1mg daily B12 injection monthly Wellbutrin xl 300mg daily Cardizem 30mg three times daily levothyroxine 200mcg daily metoprolol 50mg twice a day multivitamin xarelto 20mg daily Butrans 15mcg/hr patch weekly midodrin,Unknown,congestive heart failure with reduced EF atrial fibrillation sleep apnea acute kidney injury anemia chronic pain depression,,no known allergies,['Death'],1,MODERNA,IM 1107735,OH,90.0,M,Death on March 8 due to a large blood clot at the base of his brain. This was 16 days after innoculation.,Yes,03/08/2021,Not Reported,Yes,1.0,Not Reported,N,02/19/2021,03/07/2021,16.0,PHM,"Thyrogin, 2 blood pressure medications (sorry, don't have names), D3, Multivitamins, Lutein",Annual exam had resulted in a clean bill of health the Friday prior to his death.,"High blood pressure, thyroid.",,none,"['Cerebral thrombosis', 'Computerised tomogram', 'Death', 'Electrocardiogram']",2,MODERNA,IM 1107883,TX,86.0,M,DEATH,Not Reported,,Not Reported,Not Reported,,Not Reported,N,02/22/2021,02/22/2021,0.0,PUB,ALMODIPINE 5MCG -2/DAY HYDROCHLOROTHIAZIDE 12.5MG 1/DAY CIPROFLAXICIN 500MG - 2/DAY,"DIMENTIA, BLADDER INFECTION","BLADDER CANCER, BLADDER INFECTION",,NONE,['Death'],2,PFIZER\BIONTECH,IM 1107885,IA,82.0,M,Patient presented to the ER on 3/2 for urinary frequency and lower abdominal pain. He was hospitalized at Medical Center- on 3/2/2021 for small bowel obstruction and acute kidney injury. Patient passed on 3/2/2021.,Yes,03/02/2021,Not Reported,Not Reported,,Not Reported,N,02/24/2021,03/02/2021,6.0,PVT,"triamterene-HCTZ, atorvastatin, potassium chloride, benazepril, diltiazem, glipizide, ferrous sulfate, aspirin, omega-3 fatty acids",Patient had chronic medical conditions as listed below. No acute illnesses at the time of vaccination or within the prior month.,"bladder cancer, type 2 diabetes, hyperlipidemia, HTN, anemia, carotid atherosclerosis, osteoarthritis, inguinal hernia",,No known allergies,"['Abdominal pain lower', 'Acute kidney injury', 'Blood culture', 'Brain natriuretic peptide', 'Computerised tomogram abdomen', 'Computerised tomogram pelvis', 'Death', 'Full blood count', 'Metabolic function test', 'Pollakiuria', 'Procalcitonin', 'Small intestinal obstruction', 'Urine analysis']",1,PFIZER\BIONTECH,IM 1107898,NY,88.0,F,"5 days post-vaccination (1st dose of Moderna), patient started developing lethargy, and difficulty swallowing. 7 days post-vaccination patient looked ""ashen"". 12 days after vaccination patient was improving, but 14 days after vaccination patient was found to have (on lab work) critical hypernatremia (sodium level of 180 mmol/L), patient was re-referred back to hospice, and 17 days post-vaccination patient died.",Yes,03/16/2021,Not Reported,Not Reported,,Not Reported,N,02/27/2021,03/04/2021,5.0,UNK,senna,,"dementia, glaucoma, constipation",,none,"['Blood calcium normal', 'Blood chloride increased', 'Blood creatinine increased', 'Blood potassium normal', 'Blood sodium increased', 'Blood urea increased', 'Carbon dioxide increased', 'Death', 'Dysphagia', 'Glomerular filtration rate decreased', 'Haematocrit normal', 'Haemoglobin decreased', 'Hypernatraemia', 'Lethargy', 'Liver function test normal', 'Pallor', 'Platelet count normal', 'Protein total decreased', 'White blood cell count normal']",1,MODERNA,IM 1107923,MN,83.0,M,Patient died 2/6/21,Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/06/2021,9.0,PVT,unknown to facility,"numerous, unknown to facility","numerous, unknown to facility",,NKA,['Death'],1,MODERNA,IM 1108261,,81.0,M,death Narrative: Patient received 1st dose of Moderna COVID-19 vaccine on 03/08/2021. Patient died 03/09/2021. Medical examiner received report that patient was alert before a fall on the night of 03/08/2021. Death certificate will report death likely due to arrhythmia due to underlying CHF. Contributing factors include diabetes.,Yes,03/08/2021,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,OTH,,,,,,"['Arrhythmia', 'Cardiac failure congestive', 'Death', 'Diabetes mellitus', 'Fall']",1,MODERNA,IM 1108262,,85.0,M,"Patient passed away unrelated to covid vaccine Narrative: The patient had hypertension, diabetes, hyperlipidemia and sleep apnea. Patient received first dose of Moderna vaccine 1/15/2021 and no adverse reaction was recorded. Clinical staff called to review patient's intent for second dose, patient is not interested and has elected to not receive second dose following clinical discussion of the risks and benefits of the COVID-19 vaccination. Patient was called on 2/17/2021 and his son stated patient passed away on 2/6/2021.Cause of death not documented. No indication that death was related to COVID 19 vaccination.",Yes,02/06/2021,Not Reported,Not Reported,,Not Reported,N,01/15/2021,02/06/2021,22.0,OTH,,,,,,['Death'],1,MODERNA,IM 1108267,,81.0,M,"Deceased Narrative: Patient was a 79 yo male with a hx of HTN, ETOH and tobacco use, PVD, HLD with no contact with health care since 2014. Patient presented to facility on 9/30 with worsening bilateral leg pain and SOB. During that hospitalization he dx with severe decompensated HF (EF 20-25%) and cardiomyopathy. Cardiac cath with severe CAD, however unable to perform interventions. Upon goals of care discussion, patient no longer wished to go to facility or aggressive medical management. Patient was transitioned to hospice for comfort care.",Yes,12/22/2020,Not Reported,Not Reported,,Not Reported,N,12/17/2020,12/22/2020,5.0,OTH,,,,,,"['Cardiac failure', 'Cardiomyopathy', 'Catheterisation cardiac abnormal', 'Coronary artery disease', 'Death', 'Dyspnoea', 'Pain in extremity']",UNK,PFIZER\BIONTECH,IM 1108279,,70.0,M,"deceased Narrative: Patient was a 68M with advanced ALS, long-term need for mechanical ventilation, total care, TF, who developed worsening respiratory failure increasing difficulty with mech ventilation, unresponsive to COPD exacerbation treatment, in the setting of persistently abnormal CXR findings concerning for malignancy or other processes. After discussion with family, they did not want to patient to suffer any more and asked for mechanical ventilation be stopped after adequate comfort medications were administered. Patient was allowed to pass away naturally from his underlying advanced ALS.",Yes,02/10/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,02/10/2021,35.0,OTH,,,,,,"['Amyotrophic lateral sclerosis', 'Chest X-ray abnormal', 'Chronic obstructive pulmonary disease', 'Condition aggravated', 'Death', 'Mechanical ventilation', 'Respiratory failure']",2,PFIZER\BIONTECH,IM 1108312,NH,68.0,F,"Severe exacerbation of idiopathic capillary leak syndrome 48 hours following administeration of Janssen vaccine leading to profound vasodilatory shock, renal failure and DIC and death",Yes,03/16/2021,Not Reported,Yes,7.0,Not Reported,N,03/07/2021,03/09/2021,2.0,PVT,"elavil, lisinopril, simvastatin, terbutaline, theophylline",none,Idiopathic Capillary Leak Syndrome,,None,"['Capillary leak syndrome', 'Condition aggravated', 'Death', 'Disseminated intravascular coagulation', 'Distributive shock', 'Renal failure']",UNK,JANSSEN, 1108365,FL,78.0,F,"She had breathing problems, bowel movement problems, sharp pain -site unknown No appetite and nausea. Went to the Doctor on wednesday and they gave her a prescription for nausea (promethazine) 12.5mg She Passed away 03/12/2021 at 8:54pm waiting to be picked up by a friend that was going to take her to the emergency room/hospital.",Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/09/2021,1.0,UNK,yes but unknown,No,"Polythemavera (blood disease), Arthritis",,Unknown,"['Bowel movement irregularity', 'Death', 'Decreased appetite', 'Defaecation disorder', 'Dyspnoea', 'Nausea', 'Pain']",1,MODERNA,SYR 1108447,ME,97.0,M,"Death - deemed of natural causes, was on hospice",Yes,03/13/2021,Not Reported,Not Reported,,Not Reported,N,03/12/2021,03/13/2021,1.0,PVT,Potassium Chloride Furosemide Vit D ASA Tamsulosin,On Hospice,"Vascular Dementia, CHF, Abnormal Weight Loss, CAD, CVA",,NKA,['Death'],1,JANSSEN,IM 1108469,,78.0,F,"Deceased Narrative: This was a 77 yo F with h/o HFpEF, afib (warfarin), COPD, obesity hypoventilation syndrome, OSA on BiPAP, T2DM, RA, L-sided follicular bronchitis and newly diagnosed probably malignant pulmonary process. Patient was admitted to facility 9/26-10/15 for acute on chronic hypercarbic respiratory failure with persistent O2 requirement despite treatment for CAP, COPD and CHF exacerbation. Patient then underwent high dose steroid taper per Rheum. Patient presented an overall poor state of health and was at high risk of complications with any procedures and was not a candidate for systemic therapy for a malignancy based on functional status. Patient was accepting of terminal diagnosis and transitioned to comfort measures at home.",Yes,01/25/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/25/2021,19.0,OTH,,,,,,"['Death', 'General physical health deterioration']",2,PFIZER\BIONTECH,IM 1108470,,89.0,M,"Pulmonary Embolism Narrative: Patient was hospitalized with acute pulmonary embolis on 2/12/2021. Was started on Eloquis and discharged on 2/15/2021, with primary diagnosis of acute PE and BLE DVT. Secondary diagnosis of acute systolic heart failure with bilateral pleural effusions. On 2/17 we got notification that patient was placed on hospital.",Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,N,03/15/2021,02/12/2021,,OTH,,,,,,"['Acute left ventricular failure', 'Deep vein thrombosis', 'Pleural effusion', 'Pulmonary embolism']",1,MODERNA,IM 1108471,,77.0,M,"death Narrative: Pt received 1st moderna covid vaccine 2/12/2021 and passed away of unknown causes 2/12/2021 Pt 76 year old with AAA,HTN,CKD,COPD",Yes,02/20/2021,Not Reported,Not Reported,,Not Reported,N,02/12/2021,02/20/2021,8.0,OTH,,,,,,['Death'],1,MODERNA,IM 1108472,,59.0,M,"cardiac arrest Narrative: Per medics, Patient was gardening when he stated he felt dizzy and collapsed. Wife started CPR until medics arrived. Patient arrived at the hospital after 20min of pulseless V tach and 10 min of PEA.",Yes,03/13/2021,Not Reported,Not Reported,,Not Reported,N,03/06/2021,03/13/2021,7.0,OTH,,,,,,"['Cardiac arrest', 'Dizziness', 'Pulseless electrical activity', 'Resuscitation', 'Syncope', 'Ventricular tachycardia']",1,MODERNA,IM 1108475,,79.0,M,"death Narrative: Patient received COVID vaccine # 1 on 1/6/2021, on 1/23/21 his wife reported to the facility that he passed away. Notes in database do not mention cause of death or where death occurred. There are no scanned records in database with any detail either.",Yes,01/23/2021,Not Reported,Not Reported,,Not Reported,N,01/06/2021,01/23/2021,17.0,OTH,,,,,,['Death'],1,MODERNA,IM 1108476,,86.0,M,"Narrative: Dose #1 of vaccine was administered 2/6/21, per daughter's report patient became ill 3 days later (cough) and was taken to local hospital and was discharged with diagnosis of CAP, NSTEMI and acute on chronic CHF exacerbation. Discharged home on hospice where he passed away at home on 2/20/21.",Yes,02/20/2021,Not Reported,Yes,,Not Reported,N,02/06/2021,02/10/2021,4.0,OTH,,,,,,"['Acute myocardial infarction', 'Cardiac failure acute', 'Cardiac failure congestive', 'Condition aggravated', 'Cough', 'Death', 'Malaise', 'Pneumonia']",1,MODERNA,IM 1108477,,91.0,F,Patient died unrelated to covid vaccine Narrative: The patient had advanced Alzheimer's disease and severe dementia. Patient received the first dose of Moderna vaccine on 1/7/2021 and no adverse reaction was reported. Placed in hospice care and passed away on 1/29/2021. Cause of death not documented. No indication that death was related to COVID 19 vaccination.,Yes,01/29/2021,Not Reported,Not Reported,,Not Reported,N,01/07/2021,01/29/2021,22.0,OTH,,,,,,['Death'],1,MODERNA,IM 1108478,,84.0,M,"Death Narrative: Patient was outpatient. There was no information or document notes about reactions, underlying or active conditions between the time patient came in for the first Pfizer dose and their death.",Yes,02/26/2021,Not Reported,Yes,,Not Reported,N,01/28/2021,02/26/2021,29.0,OTH,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1108588,IL,80.0,F,"After vaccine (2nd dose) on 3/04, patient resumed normal activities, running errands, etc. In the evening of 3/05, patient complained of extremely sore arms (not alleviated by painkillers) and nausea. Additionally, patient felt extremely cold. She went to bed early, at 7:00 pm, and was found dead the next morning 3/06 at 7:30 am. She had vomited. The coroner (not a medical examiner) declared cause of death as 1) cardiac arrest 2) hypertension and 3)hypercholesterolemia, based solely on medical records. There was no autopsy. Due to or despite medications, patient's blood pressure readings were typically low (last one 118/70), pulse normal (89), BMI 25.29, cholesterol levels normal (166/LDL 82), blood sugar 95.",Yes,03/06/2021,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/05/2021,1.0,PVT,"anastrozole (1mg);cyanocobalamin (1,000 mcg);LORazepam (.5 mg); metropolol tartrate (50 mg); pravastatin (20 mg); turmeric root extract (500 mg); multivitaim (C, E, copper, zinc, lutein)",,"mitral valve prolapse (longstanding)hypertension/hypercholesterolemia/mixed hyperlipidem; last tests = normal levels; malignant neoplasm of left breast (estrogen receptive positive), removed and several years cancer-free.",,,"['Blood cholesterol normal', 'Blood glucose normal', 'Blood lactate dehydrogenase decreased', 'Blood pressure decreased', 'Cardiac arrest', 'Condition aggravated', 'Death', 'Feeling cold', 'Heart rate normal', 'Hypercholesterolaemia', 'Hypertension', 'Nausea', 'Pain in extremity', 'Vomiting']",UNK,MODERNA, 1108595,IN,87.0,M,"senescence, hypotensive reaction to COVID-19 vaccination, COPD",Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,02/13/2021,3.0,SEN,,,"Alzheimers dementia, COPD",,,"['Chronic obstructive pulmonary disease', 'Condition aggravated', 'General physical health deterioration', 'Hypotension']",2,MODERNA,IM 1108609,NY,66.0,F,"Patient was found unresponsive the morning of March 14, 2021. She was pronounced dead at 5:33 AM. The medical examiner quoted natural cause of death.",Yes,03/14/2021,Not Reported,Not Reported,,Not Reported,,03/13/2021,03/14/2021,1.0,PVT,See additional information,,See additional information,,,"['Death', 'Unresponsive to stimuli']",2,MODERNA,IM 1108623,LA,72.0,M,"Fatigue, Body aches, loss of appetite, 100 degree fever for a short time. indigestion, nausea for about 3 days Fatal Heart attack 2/28/2021",Yes,02/28/2021,Not Reported,Not Reported,,Not Reported,N,02/24/2021,02/25/2021,1.0,PHM,"Centrum Silver for Men, Calcium-Vit D 185mg, Aspirin 81mg, Escitalopram oxalate 10 mg, Hydrochlorothiazide 12.5 mg, Losartan Potassium 100 mg, Tamsulosin HCl 0.4 mg",hayfever,High blood pressure Obesity,,Penicillin Clindamycin,"['Death', 'Decreased appetite', 'Dyspepsia', 'Fatigue', 'Myocardial infarction', 'Nausea', 'Pain', 'Pyrexia']",2,MODERNA,IM 1108762,NH,73.0,M,Patient without previous cardiovascular history with complaints of chest tightness and diaphoresis. Contacted the doctor's office and sent advise to go to ER for possible cardiovascular event. Witnessed cardiac arrest at home with unsuccessful resuscitation.,Yes,03/15/2021,Not Reported,Not Reported,,Not Reported,N,02/26/2021,03/15/2021,17.0,OTH,Valcyclovir as needed. Viagra as needed,None,Mild hypertension and mixed hyperlipidemia on diet therapy and Impaired fasting glucose,,Thonzyldiamine,"['Cardiac arrest', 'Chest discomfort', 'Hyperhidrosis', 'Resuscitation']",UNK,PFIZER\BIONTECH,IM 1108766,IN,78.0,M,"Family reported today 3/17/2021 that patient passed away 3/12/2021, they did not indicate that it had anything to do with the vaccination or give medical history.",Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,02/17/2021,03/12/2021,23.0,PUB,,,,,,['Death'],1,MODERNA,IM 1108959,CA,73.0,M,"Stroke resulting in death. Admitted to hospital 2/21/21 as transfer from first Hospital after found collapsed in his hotel room. Left M1 occlusion, thrombectomy performed, then had hemorrhagic trnasformation. Developed worsening respiratory status after extubation, was reintubated. Given poor neurologic status, was extubated and started on palliative morphine drip. Pt died 0100 3/1/21.",Yes,03/01/2021,Not Reported,Not Reported,,Not Reported,N,02/18/2021,02/21/2021,3.0,PUB,"metoprolol XL, Rivaroxaban",Atrial fibrillation Alcoholism,Atrial fibrillation Alcoholism,,NKDA,"['Angiogram cerebral', 'Cerebral artery occlusion', 'Computerised tomogram head', 'Death', 'Endotracheal intubation', 'Haemorrhagic transformation stroke', 'Magnetic resonance imaging head', 'Neurological decompensation', 'Respiratory distress', 'Syncope', 'Thrombectomy']",UNK,MODERNA,IM 1108969,FL,48.0,M,"Per patient's Mother, patient c/o tingling and aches/pains. 3:00 AM onset of ""uncontrollable"" diarrhea. 8:30 AM fatigues, weak, and clammy. Patient found unresponsive on 3-12-2021 at 13:00 and was pronounced dead.",Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,03/11/2021,03/12/2021,1.0,OTH,"gabapentin 800mg, Methocarbanol 500mg, pantoprazole 40mg, propranolol 40mg, Sucralfate 1Gram, Zyrtec 10mg","allergic rhinitis, bipolar disorder, colon polyps, HTN, lumbago with Sciatica, Solitary pulmonary nodule, pure hypercholestermia",See above,,NKA,"['Asthenia', 'Autopsy', 'Cold sweat', 'Death', 'Diarrhoea', 'Fatigue', 'Pain', 'Paraesthesia', 'Toxicologic test', 'Unresponsive to stimuli']",1,MODERNA,IM 1109087,IL,91.0,M,Pt expired in Community Hospital ED on 3-10-21. This was 5 days after receiving his second Moderna covid vaccination. Hospital nurse says ED report says multiple system problems.,Yes,03/10/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/10/2021,5.0,PUB,unknown,"diabetes, heart disease, kidney failure, possible cancer",same as above,,,"['Death', 'Multi-organ disorder']",2,MODERNA,IM 1109309,TX,92.0,F,After vaccine was administered patient was seemingly fine until a loss of consciousness/mini stroke on Jan 16 (5 days after vaccine) causing a fall and massive stroke on Jan 22 (11 days after vaccine) that left patient unresponsive and on life support until family decided to stop services and begin hospice care with no fluids or food until death,Yes,02/03/2021,Not Reported,Not Reported,,Not Reported,N,01/11/2021,01/16/2021,5.0,SEN,None,None,Alzheimer's,,None,"['Blood test', 'Cerebrovascular accident', 'Death', 'Fall', 'Life support', 'Loss of consciousness', 'Magnetic resonance imaging', 'Transient ischaemic attack', 'Unresponsive to stimuli']",1,PFIZER\BIONTECH,SYR 1109346,OR,86.0,F,"When patient didn't show up for her second COVID-19 vaccine today 3/17/21, we couldn't reach her so we contacted her Dr. office. They informed us that patient visited the emergency department on 2/22/21 and passed away while in the hospital on 2/23/21.",Yes,02/23/2021,Not Reported,Yes,,Not Reported,N,02/17/2021,02/23/2021,6.0,PHM,,,,,,['Death'],1,MODERNA,IM 1109350,MO,67.0,F,unexplained death on 3/15/21,Yes,03/15/2021,Not Reported,Not Reported,,Not Reported,N,03/11/2021,03/15/2021,4.0,PVT,"codeine-guafenesin, omeprazole, tizanidine, duloxetine, doxepin, ondansetron, amlodipine, fluticasone-salmeterol, monteleukast, ropinirole, simvastatin, cetirzine, bupropion, buspirone, methotrexate, oxycodone, loperamide, ergocalciferol","admission 2/28-3/1 for chronic cough, recent sob, chest pain. evaluation at that time including CTA chest, cardiac stress test unremarkable. further outpatient evaluation for the cough was pending.","GERD, HTN, DM, HLD, Bipolar, PMR, RA, asthma",,"adhesive, aluminum-magnesium hydroxide, dicloxacillin, ketorolac, lidocaine, penicillin, povidone-iodine",['Death'],1,PFIZER\BIONTECH,IM 1109418,CA,62.0,M,"sudden death, while sleeping 2 days after injection Vaccine 3/12/21 last seen conversant and comfortable at 3a 3/14/21 Found nonresponsive and not breathing at 8:30a 3/14/21",Yes,03/14/2021,Not Reported,Not Reported,,Not Reported,N,03/12/2021,03/14/2021,2.0,PUB,"rosuvastatin 20, propranol 120mg ER, gabapentin, primidone 250 BID","essential tremor, s/p successful DBS neurosurgery 3/9/21",Dyslipidemia Essential tremor developmental delay,,NKDA,"['Respiratory arrest', 'Sudden death', 'Unresponsive to stimuli']",2,MODERNA,IM 1109427,OK,81.0,M,"Moderna Covid-19 Vaccine EUA After receiving the first vaccine, started making gasping noises at night, lethargy, fit bit would not register sleep at night, some breathing issues during waking hours. HR observed to decrease to under 40 over the last week of his life. 5 days after 2nd vaccine had extreme fatigue, nightmares, forgot to take regular meds in the morning, 6 days after he woke up very confused and had nightmares and 7 days after vaccination woke up late, exhausted, with shortness of breath all day and refused to go to ER. Went to bed early and died in the night with his CPAP machine on.",Yes,03/07/2021,Not Reported,Not Reported,,Not Reported,N,02/26/2021,02/26/2021,0.0,PVT,"Furosemide,K-Tab/Potassium, Eliquis, Amlodipine Besylate, Lisinopril, Gabapentin,Lipator",No illnesses,Atrial Fibrillation High Blood Pressure Diabetes Sleep Apnea,,Iodine,"['Confusional state', 'Continuous positive airway pressure', 'Death', 'Dyspnoea', 'Fatigue', 'Heart rate decreased', 'Lethargy', 'Memory impairment', 'Nightmare']",2,MODERNA,IM 1109535,TN,78.0,M,My Father had a hemorrhagic stroke. He passed away 13 days after receiving the second Modern?s vaccine.,Yes,03/11/2021,Not Reported,Not Reported,,Not Reported,N,02/26/2021,03/10/2021,12.0,PVT,Don?t know the prescriptions being taken,Not aware of any,Diabetes,,,"['Death', 'Haemorrhagic stroke']",UNK,MODERNA, 1109552,OR,82.0,F,"Family call Clinical Lead to car for elderly woman in backseat of car who had become unresponsive. � Patient lying on side. Wearing portable NC o2. Unresponsive to verbal/sternal rub. No pulse, No resps. � Called AMR to car side who called 911. Transferred patient to a gurney and began CPR as we transferred to AMR rig. � EKG - showed PEA - CPR continued - patient intubated by AMR - epi is given. � Pt transported by AMR/Fire to hospital. � Pt was a full code on Hospice - she passed away 3/11/21 with the following cause of death: 1.Acute-on-chronic hypoxemic/hypercarbic respiratory failure, multifactorial in origin. 2. Possible aspiration pneumonia, present on admission. 3. Bronchiectasis, chronic, secondary to asbestosis. 4. Acute combined metabolic and toxic encephalopathy, present on admission. 5. Out of hospital pulseless electrical activity arrest. 6. Hyperkalemia. 7. Cardiogenic shock. 8. Acute kidney injury. 9. Lactic acidosis. 10. Acute diastolic congestive heart failure. 11. Severe protein-calorie malnutrition.",Yes,03/11/2021,Not Reported,Yes,1.0,Not Reported,U,03/06/2021,03/06/2021,0.0,OTH,Unknown,PMHx: 02 use for chronic pneumonia and Ascending Aortic Aneurysm - on Hospice Full Code,PMHx: 02 use for chronic pneumonia and Ascending Aortic Aneurysm,,Unknown,"['Acute kidney injury', 'Acute left ventricular failure', 'Asbestosis', 'Bronchiectasis', 'Cardiac failure congestive', 'Cardio-respiratory arrest', 'Cardiogenic shock', 'Death', 'Echocardiogram', 'Electrocardiogram abnormal', 'Endotracheal intubation', 'Hypercapnia', 'Hyperkalaemia', 'Hypoxia', 'Intensive care', 'Lactic acidosis', 'Malnutrition', 'Pulse absent', 'Pulseless electrical activity', 'Respiratory arrest', 'Respiratory failure', 'Resuscitation', 'Toxic encephalopathy', 'Unresponsive to stimuli']",UNK,PFIZER\BIONTECH,IM 1109578,KY,92.0,M,Patient died at nursing home.,Yes,03/17/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,03/17/2021,48.0,SEN,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1109696,NY,64.0,M,"Pt presented to the ER on 1/4 2021 with worsening sob, found to have acute ST elevation MI and new rapid atrial fib with RVR. He tested positive for covid 19 requiring new oxygen and received his first pfizer vaccine on 12/31. He was acutely transferred to rochester general hospital. He progressed to multiorgan failure, sepsis, mrsa bacteremia and died on 1/14/2021",Yes,01/14/2021,Not Reported,Yes,10.0,Not Reported,N,12/31/2020,01/04/2021,4.0,UNK,"atorvastatin, omeprazole, folic acid, furosemide, methotrexate weekly, metoprolol, ozempic",tested positive for covid 19 on 12/14/2021,"HTN, DM, arthritis, ckd , hyperlipidemia",,None,"['Acute myocardial infarction', 'Atrial fibrillation', 'Blood lactate dehydrogenase increased', 'COVID-19', 'Death', 'Dyspnoea', 'Metabolic function test normal', 'Multiple organ dysfunction syndrome', 'SARS-CoV-2 test positive', 'Sepsis', 'Serum ferritin increased', 'Staphylococcal bacteraemia']",1,PFIZER\BIONTECH,IM 1109881,OH,46.0,F,"two pulmonary embolisms in right lung/Found old pulmonary embolism in left lung; pain moved up bilaterally to her arms, neck and jaw; pain in neck; pain moved up bilaterally to her arms, neck and jaw; wasn't able to ambulate independently; Rib pain; temperature of 101.8; significant decrease in appetite; unusual pain in her legs, hips and lower back; A spontaneous report was received from a nurse concerning a 46-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced unusual pain in her legs, hips, lower back, pain in both arms, neck jaw and ribs, decrease in appetite, fever, and pulmonary embolism. The patient's medical history was not provided. Concomitant medications included levothyroxine, prednisone, tizanidine and apixaban. On 30-Dec-2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot/batch 011J20A) intramuscularly for prophylaxis of COVID-19 infection and patient had a sore arm, muscle aches and slight headaches. On 25-Jan-2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 026L20A) intramuscularly for prophylaxis of COVID-19 infection. On 03-Feb-2021 the patient started developing an unusual pain in her legs, hips, and lower back that eventually moved up to her arms, neck and jaw. She reported that she had a significant decrease in appetite that Saturday, 06-Feb-2021, and on 07-Feb-2021, she had a temperature of 101.8. She reported feeling like she had the flu. Patient reported having a COVID-19 test that came back negative. The pain continued to increase between Sunday night and Tuesday morning. Patient then developed pain in her ribs when she would lay down. She wasn't able to ambulate independently. On 09-Feb-2021, she went to the hospital. They did a chest X-ray and computed tomography (CT) scan. Those tests showed two new pulmonary embolisms in the right lung and an old pulmonary embolism in the left lung. Patient was hospitalized 09-FEb-2021 until 12-Feb-2021. She reported that her body was still inflamed. In her labs it showed her thyroid levels had doubled from her previously good thyroid levels checked in Oct 2020. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with mRNA-1273 in response to the events was not applicable. The outcomes of the events, pain in her legs, hips, lower back, neck, jaw bilateral arm pain, decrease in appetite, fever, pain in ribs and pulmonary embolism, were considered controlled with medication.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,4.0,Not Reported,U,12/30/2020,02/03/2021,35.0,UNK,LEVOTHYROXINE; PREDNISONE; TIZANIDINE; APIXABAN,,Medical History/Concurrent Conditions: No adverse event (No medical history reported.),,,"['Arthralgia', 'Body temperature', 'Chest X-ray', 'Computerised tomogram', 'Decreased appetite', 'Gait disturbance', 'Musculoskeletal chest pain', 'Neck pain', 'Pain in extremity', 'Pain in jaw', 'Pulmonary embolism', 'Pyrexia', 'SARS-CoV-2 test', 'Thyroid hormones increased']",1,MODERNA,OT 1110099,FL,69.0,M,"3/12/21 Sudden cardiac arrest at home; unable to be resuscitated at scene (Brother) Caller is a family friend who was asked by family to call and report incident. If f/u is needed, please contact him first. Current Medical History: unknown by caller Current Medications: unknown by caller",Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,03/10/2021,03/12/2021,2.0,UNK,,,,,,"['Cardiac arrest', 'Resuscitation']",1,JANSSEN,IM 1110152,PA,60.0,F,This is a 60 year old female was brought into emergency department as cardiac arrest. Patient was seen at care now urgent care with the complain of epigastric pain associated with nausea vomiting and intermittent diarrhea. Patient received her initial COVID vaccine 2 days ago. History is obtained from urgent care chart. As per notes patient started nausea vomiting 6 hours post COVID vaccine administration. Patient was seen in urgent care for epigastric pain and nausea vomiting. Patient was found unresponsive at 0902 by tech. No carotid pulses palpated. CPR was started. Patient was brought into the emergency department with Lucas on. Patient was given 5 epinephrine prior to arrival. CPR was in progress. Patient was asystole. Resuscitation was continued in the ED. Patient was intubated in the ED by physician assistant 5 epinephrine 2 bicarb and 1 calcium chloride was given in the ED. Cardiac Ultrasound didn't show any cardiac activity. Asystole on the monitor. No corneal reflex people are fixed and dilated. Patient was pronounced at 1007 am,Yes,03/13/2021,Not Reported,Not Reported,,Not Reported,N,03/11/2021,03/13/2021,2.0,PVT,MEDS Prescriptions Last Dose Informant Patient Reported? Taking? Empagliflozin-metFORMIN HCl (Synjardy) 12.5-500 MG TABS No No Sig: Take 1 tablet by mouth 2 (two) times a day Multiple Vitamins-Minerals (CENTRUM SILVER 50+WOMEN PO) Sel,"Medical History Past Medical History: Diagnosis Date ? Diabetes (HCC) ? Diabetes mellitus (HCC) ? Hypertension ? Type 2 diabetes mellitus without complication, without long-term current use of insulin (HCC) 12/2/2019 Past Surgical History: Procedure Laterality Date ? CATARACT EXTRACTION ? CESAREAN SECTION ? RETINAL DETACHMENT SURGERY Left 1985 ? TONSILECTOMY, ADENOIDECTOMY, BILATERAL MYRINGOTOMY AND TUBES","Medical History Past Medical History: Diagnosis Date ? Diabetes (HCC) ? Diabetes mellitus (HCC) ? Hypertension ? Type 2 diabetes mellitus without complication, without long-term current use of insulin (HCC) 12/2/2019 Past Surgical History: Procedure Laterality Date ? CATARACT EXTRACTION ? CESAREAN SECTION ? RETINAL DETACHMENT SURGERY Left 1985 ? TONSILECTOMY, ADENOIDECTOMY, BILATERAL MYRINGOTOMY AND TUBES",,Allergies Ceclor [Cefaclor]Rash Adhesive [Medical Tape]Rash,"['Abdominal pain upper', 'Cardiac arrest', 'Corneal reflex decreased', 'Death', 'Diarrhoea', 'Echocardiogram', 'Endotracheal intubation', 'Life support', 'Nausea', 'Pulse absent', 'Pulseless electrical activity', 'Pupil fixed', 'Resuscitation', 'Unresponsive to stimuli', 'Vomiting']",UNK,PFIZER\BIONTECH, 1110160,GA,78.0,M,"Phone call from patient' s 2 daughters on 3/10/2021. Patient was found dead in bed with a remote in his hand. He had not been sick. He had received Moderna SARS vaccine 2/27/2021= 11 days earlier, but did not have any adverse reactions. He had recovered from lumbar spine surgery several months earlier. He was pronounced dead by the fire chief.",Yes,03/10/2021,Not Reported,Not Reported,,Not Reported,,02/27/2021,03/10/2021,11.0,PVT,"Albuterol, Amlodopine, Aspirin, Atorvastatin, Benazepil, Budesonide-Formoterol, Carvedilol, Cyanocobalamin, Furosemide, Lidocaine, Metoprolol, Nitroglycerin, Omeprazole, Pantoprazole, Tamsulosin, Terbinafine, Tizanidine, Tylenol, Venlafaxin",,"Cardiovascular and Mediastinum Coronary artery disease involving native coronary artery of native heart without angina pectoris Enlarged aorta (HC) HTN (hypertension), benign Nervous and Auditory Cervical radiculopathy Musculoskeletal and Integument Adhesive capsulitis of right shoulder Cervical disc disorder Closed fracture of shaft of humerus Degeneration of lumbar intervertebral disc Fracture of phalanx of thumb Spondylolisthesis Avascular necrosis (HC) Other History of selective injection of anesthetic agent around lumbar nerve root Shoulder joint pain Weight gain Iron deficiency anemia secondary to inadequate dietary iron intake Mixed hyperlipidemia Spinal stenosis of lumbosacral region",,Iodine,['Death'],2,MODERNA,IM 1110232,CA,79.0,M,"DizzineS, sweating,weak, chilling, diarrhea, shortness of breath, death",Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,N,03/01/2021,03/04/2021,3.0,PVT,"Levothyroxine,indapamide,glipizide,metropololtartate,almodipine,lisinopril,b12,d3","Hipertension,diabetic,kidney problem,abdominal aneurism,thyroidproblem","Thyroid problem, kidney problem , diabetic , hypertension, abdominal aneurism",,Hair dye,"['Asthenia', 'Chills', 'Death', 'Diarrhoea', 'Dizziness', 'Dyspnoea', 'Hyperhidrosis']",UNK,MODERNA, 1110311,MN,91.0,M,patient passed away within 60 days of receiving a COVID vaccine,Yes,03/04/2021,Not Reported,Not Reported,,Not Reported,,02/09/2021,03/04/2021,23.0,SEN,,,,,,['Death'],UNK,MODERNA, 1110329,,63.0,F,Patient passed away within 60 days of receiving the COVID vaccine series,Yes,03/04/2021,Not Reported,Not Reported,,Not Reported,,01/29/2021,03/04/2021,34.0,PVT,,,,,,['Death'],2,PFIZER\BIONTECH, 1110388,PR,60.0,F,"On 2/1/2021 they performed CBC, the result was aseptic bacteria so it came out and she was taken to the hospital. They removed the tube in the hospital, (she remained in the hospital) First she was hospitalized and then she was transferred to the Medical Center Hospital to auscultate bleeding in the stool and to be evaluated by the Gastroenterologist. This specialist performs the necessary studies, they do not give a diagnosis and in the process she dies. The hospital indicated that she had a blood drain and heart failure.",Yes,03/14/2021,Not Reported,Not Reported,,Not Reported,N,02/01/2021,02/02/2021,1.0,SEN,"Isorbi 30mg, Metroprolo 25mg, Plavis 75 mg, rosubastatin 20mg",A few days previous to the vaccination the resident was evacuating blood and was suppurating through the PEC tube.,"CVA, Right side paralysis, did not speak, cardiovascular conditions, diabetes and depression.",,Not reported,"['Auscultation', 'Bacterial infection', 'Bloody discharge', 'Cardiac failure', 'Colostomy infection', 'Culture stool positive', 'Death', 'Full blood count abnormal', 'Gastrostomy tube removal']",1,MODERNA,IM 1110437,PR,76.0,F,"Since the vaccine was administered on 1/30/2021 the resident was complaining of tiredness. On 2/9/2021 she complains more than usual with fatigue, a lot of fatigue so they make the decision to transfer her to the hospital. In the hospital she was informed that the pain was from a gallbladder stone, also that she has a lung condition and a compromised kidney. A Dr. from Hospital tells POC that the patient was not responding to treatments and was compromised thus prolonging the hospital stay.",Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,01/30/2021,02/09/2021,10.0,SEN,"Corect 25mg, Ferrous Sulfate 325 mg, Synocril, Norvasc 10 mg, Plavix 75mg, Lipitor 10 mg, Ativan 1mg, Insulin 70/10 10 units. Vitamin C and Tussin.",None reported,"Cardiovascular conditions, Diabetes, Chronic liver condition, Hypertension, Depression.",,Not reported,"['Absence of immediate treatment response', 'Biliary colic', 'Cholelithiasis', 'Fatigue', 'Lung disorder', 'Renal impairment']",1,MODERNA,IM 1110439,RI,94.0,M,Tolerated Well without complications,Yes,03/18/2021,Not Reported,Not Reported,,Not Reported,U,03/10/2021,03/10/2021,0.0,PVT,,,"DM, HTN",,"aspirin, honey",['Death'],2,MODERNA,IM 1110462,MN,84.0,F,Patient passed away within 60 days of receiving a COVID vaccine,Yes,01/28/2021,Not Reported,Not Reported,,Not Reported,,01/21/2021,01/28/2021,7.0,SEN,,,,,,['Death'],1,MODERNA, 1110537,NE,79.0,M,Pt was found to be having stroke like symptoms 3/15 in the morning at nursing home. he was evaluated and was transported by ambulance from one hospital to another hospital as the CT scanner was down. patient had an injury on march 1 with a cabinet falling on him breaking his femur and family not sure if at that time he had hit his head. Patient was intubated in the ER CT scan showed a massive cerebral bleed with midline shift and transtentorial herniation,Yes,03/15/2021,Not Reported,Not Reported,,Not Reported,N,03/12/2021,03/15/2021,3.0,OTH,"ACETAMINOPHEN, AMIODARONE, ELIQUIS, LEVOTHYROXINE, LOSATAN, PRIMADONE, TRIMETHOPRIM, NORCOAR, VALIUM",FX FEMUR,"A-FIB, ARTHRITIS, COLON CA COPD, SAD, GERD, HYPERSHOLESTEREMIA, HYPERTENSION, NEUROPATHY",,NKA,"['Brain herniation', 'Cerebral haemorrhage', 'Cerebral mass effect', 'Computerised tomogram head abnormal', 'Endotracheal intubation', 'Neurological symptom']",2,MODERNA,IM 1110581,IL,94.0,F,"Withing 24 hours of vaccine admin developed nausea, chills, aches, dyspnea, elevated heart rate. Saw PCP on 2/15 and was sent to ER and then admitted to hospital for 5 days-continued extreme nausea and atrial fibrillation after diuresis for CHF. HR 120s had to be put on multiple meds to bring ratedown. Discharged on 2/19. Cont worsening nauaea/chills/aches. Passed away on 2/23",Yes,02/23/2021,Not Reported,Yes,5.0,Not Reported,N,02/13/2021,02/15/2021,2.0,PHM,"Atenolol, Vit D3, Vit B12, Lasix, Calcitrol",none,"CKD, HTN,",,none,"['Atrial fibrillation', 'Blood electrolytes', 'Cardiac failure congestive', 'Chills', 'Coagulation test', 'Death', 'Dyspnoea', 'Echocardiogram', 'Haematocrit', 'Haemoglobin', 'Heart rate increased', 'Nausea', 'Pain', 'Polyuria', 'Vascular imaging']",1,MODERNA,IM 1110641,,83.0,F,Patient passed away within 60 days of receiving a COVID vaccine,Yes,02/23/2021,Not Reported,Not Reported,,Not Reported,,01/12/2021,02/23/2021,42.0,SEN,,,,,,['Death'],1,MODERNA, 1110654,,77.0,F,Constipation Shortness of Breath Death,Yes,03/16/2021,Not Reported,Yes,,Not Reported,,02/01/2021,02/25/2021,24.0,PVT,,,,,,"['Constipation', 'Death', 'Dyspnoea']",1,PFIZER\BIONTECH,IM 1110673,,83.0,M,shoulder injury death,Yes,03/17/2021,Not Reported,Yes,,Not Reported,,01/28/2021,02/11/2021,14.0,PVT,,,,,,"['Death', 'Limb injury']",2,PFIZER\BIONTECH,IM 1110693,,79.0,M,death,Yes,03/17/2021,Not Reported,Not Reported,,Not Reported,,02/05/2021,03/17/2021,40.0,PVT,,,,,,['Death'],2,PFIZER\BIONTECH,IM 1110696,MN,76.0,F,Patient passed away within 60 days of receiving a COVID vaccine,Yes,02/13/2021,Not Reported,Not Reported,,Not Reported,,01/22/2021,02/13/2021,22.0,SEN,,,,,,['Death'],1,MODERNA, 1110712,,93.0,F,death,Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,,02/27/2021,03/12/2021,13.0,PVT,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1110732,,66.0,F,death,Yes,02/08/2021,Not Reported,Not Reported,,Not Reported,,01/20/2021,02/08/2021,19.0,UNK,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1110978,TX,54.0,M,Unknown information regarding side effects from first Moderna Covid vaccine. Second Covid vaccine on 2/12/2021 and there were no issues. Patient died on 31/10/2021. Postmortem Covid test is negative for SARS-CoV2 RNA.,Yes,,Not Reported,Not Reported,,Not Reported,,02/12/2021,02/12/2021,0.0,UNK,,,,,,"['Death', 'SARS-CoV-2 RNA undetectable']",2,MODERNA,UN 1111006,TX,73.0,F,"On 03/08/2021, patient began not feeling well. She complained of nausea, vominting and diarrhea. Her husband reported that she received the first vaccine in 02/2021 and complained of not feeling well. Patient died on 3/12/2021.",Yes,,Not Reported,Not Reported,,Not Reported,,02/01/2021,02/01/2021,0.0,UNK,,,,,,"['Death', 'Diarrhoea', 'Malaise', 'Nausea', 'Vomiting']",2,PFIZER\BIONTECH,UN 1111039,MN,77.0,F,patient passed away within 60 days of receiving a COVID vaccine,Yes,02/21/2021,Not Reported,Not Reported,,Not Reported,,02/03/2021,02/21/2021,18.0,OTH,,,,,,['Death'],1,PFIZER\BIONTECH, 1111042,IN,71.0,M,RHC 3/15/21. No significant reaction from vaccine. Had sore arm.,Yes,03/15/2021,Not Reported,Not Reported,,Not Reported,N,03/10/2021,03/15/2021,5.0,SEN,"Atorvastin, Lantus, Bacid, Ferrous Sulfate, Flomax, Gabapentin, Lasix, Metoprolol, Norvasc, Duloxatine","None, admitted to this facility on 2/4/21. Recently declining condition, decreased appetite.","DM, Unspecified behavioral syndromes associated w/ physiological disturbances and physical factors, CAD, HTN, Chronic pain syndrome, physical deconditioning, anemia, CKD, hyperlipidemia",,NKA,"['Pain in extremity', 'Respiratory arrest']",UNK,MODERNA,IM 1111300,PA,92.0,M,"patient died of complications of pneumonia related to COVID-19; patient died of complications of pneumonia related to COVID-19; This is a spontaneous report from a contactable consumer. A 92-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 06Jan2021 at 13:00 (at the age of 92-years-old) as a single dose for COVID-19 immunization. Medical history included melanoma, chronic obstructive pulmonary disease, diabetes mellitus, and diminished kidney function; all from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was taking unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was vaccinated on 06Jan2021 during an existing hospitalization. On 22Jan2021, the patient developed pneumonia related to COVID-19. The patient did not receive any treatment. On 03Feb2021, the patient died of complications of pneumonia related to COVID-19. It was not reported if an autopsy was performed. The events were serious for hospitalization prolongation, being life-threatening and death. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: patient died of complications of pneumonia related to COVID-19",Yes,02/03/2021,Yes,Not Reported,,Not Reported,N,01/06/2021,01/22/2021,16.0,SEN,,Hospitalization,Medical History/Concurrent Conditions: COPD; Diabetes; Kidney function abnormal; Melanoma,,,"['COVID-19 pneumonia', 'Drug ineffective']",1,PFIZER\BIONTECH, 1111389,NC,80.0,M,"Cough started on 3/5. Hospitalization on 3/7, Expired 3/16. Doctor's Death Diagnosis: acute on chronic respiratory failure.",Yes,03/16/2021,Not Reported,Yes,10.0,Not Reported,N,02/24/2021,03/05/2021,9.0,PVT,"Proair, Xanax, Cardizem, Lasix, Insulin, Magnesium","PMH of Hypertension, H/o of HFpEF, PAF not on anticoagulation due to GI bleeding, Severe Pulmonary hypertension, T2DM, H/o of GI bleeding, ESRD on HD, Chronic hypoxic respiratory failure on home oxygen.","PMH of Hypertension, H/o of HFpEF, PAF not on anticoagulation due to GI bleeding, Severe Pulmonary hypertension, T2DM, H/o of GI bleeding, ESRD on HD, Chronic hypoxic respiratory failure on home oxygen.",,none,"['Acute respiratory failure', 'COVID-19', 'Condition aggravated', 'Cough', 'Death', 'SARS-CoV-2 antibody test negative', 'SARS-CoV-2 test positive']",2,MODERNA,IM 1111406,MD,85.0,F,"02/28/2021 @ 12:00 PM - sore arm, more than normal, at sight of injection; not feeling right 03/01/2021 @ AM - arm so sore that she could hardly move whole arm to hold stair rail; fatigued; not feeling right 03/04/2021 - diarrhea 6 x; fatigued; not feeling right 03/05/2021 - still had diarrhea; fatigued 03/06/2021 - 1/6 cup of urine only when she woke up in the morning; fatigued; diarrhea during AM; seemed to stop diarrhea PM and urinated maybe 2/3 cup urine more; found an almost unnoticeable bulge between the 2 collar bones above the sternum, still not feeling right 03/07/2021 - after waking up to go to the bathroom approximately 6:00 AM, incontinent wit BM, vomited",Yes,03/07/2021,Not Reported,Not Reported,,Not Reported,N,02/28/2021,02/28/2021,0.0,PVT,"Novalog long acting insulin 13 units, Basaglar short acting insulin sliding scale 3 x daily , Fuerosimide 20 mg, Losartan 25 mg 2x daily, Ferrex 150 mg daily, Vitamin D3 25 mcg 4 days per week, Ezetimibe 10 mg, Atenolol 50 mg, Norvasc 5 mg",,"Stenosis of coritid artery (70%), Diabetes Type II, Double coronary bypass, stomach ulcer, low hemoglobin, ventral hernia, CKD",,"Lisinopril, Prednisone","['Anal incontinence', 'Diarrhoea', 'Fatigue', 'Feeling abnormal', 'Grip strength decreased', 'Injected limb mobility decreased', 'Injection site pain', 'Swelling', 'Urine output decreased', 'Vomiting']",2,PFIZER\BIONTECH,IM 1111546,OH,77.0,F,"One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14.",Yes,03/14/2021,Not Reported,Not Reported,,Not Reported,N,03/02/2021,03/09/2021,7.0,PUB,"levothyroxine, omeprazole, diltiazem, fenofibrate, atorvastatin, iron, ativan, vitamins",,"heart stents, crystallized aorta, recovering from GI bleed, thyroid cancer, Hodgkins stage 2B, heart and lung problems, fibromyalgia, lupus like disorder",,,"['Abdominal distension', 'Blood pressure decreased', 'Cardiac arrest', 'Choking', 'Choking sensation', 'Cold sweat', 'Cough', 'Dehydration', 'Dyspnoea', 'Feeding disorder', 'Feeling abnormal', 'Fluid intake reduced', 'Gastrointestinal pain', 'Lethargy', 'Pain', 'Pneumonia', 'Productive cough', 'Respiratory arrest']",1,PFIZER\BIONTECH,IM 1111574,FL,68.0,F,"Passed away 4 days after second dose, complained of not being able to breathe in the middle of the night, and passed minutes later.",Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,03/08/2021,03/11/2021,3.0,PUB,,,,,,"['Death', 'Dyspnoea']",2,MODERNA,SYR 1111624,KY,88.0,U,expired on 02/09/2021,Yes,02/09/2021,Not Reported,Not Reported,,Not Reported,,01/27/2021,02/09/2021,13.0,PHM,,,,,,['Death'],1,PFIZER\BIONTECH,IM 1111645,IL,94.0,F,"Patient was a resident on a LTC wing. Received Covid-19 vaccine on 1/13/21 & 2/10/21. Pt stated she felt phlegm in her throat 3/14/21. On 3/15/21 patient started having trouble swallowing, and started needing supplemental oxygen for low oxygen saturation and needing suctioned for c/o being unable to swallow.. ST eval showed no gag reflex and inability to swallow effectively or safely. Pt needed 5L/O2 and unable to hold saturations above 90%. Patient became ?comfort care?, and passed away 3/18/21.",Yes,03/18/2021,Not Reported,Not Reported,,Not Reported,N,02/10/2021,03/18/2021,36.0,PVT,,"Hx: CAD, HTN, GERD, anxiety","Hx: CAD, HTN, GERD, anxiety",,NKA,"['Areflexia', 'Death', 'Dysphagia', 'Oxygen saturation decreased', 'Productive cough']",2,MODERNA,IM 1111683,AR,73.0,M,"Patient's niece reported that the patient's arm became sore, had stomach upset, fever the day after the vaccine. The following day the patient died.",Yes,03/17/2021,Not Reported,Not Reported,,Not Reported,N,03/15/2021,03/16/2021,1.0,PHM,pt does not fill medications here he only came for the vaccine,,,,,"['Abdominal discomfort', 'Death', 'Pain in extremity', 'Pyrexia']",1,MODERNA,IM 1111699,MO,69.0,M,"Patient developed symptomatic COVID infection with symptoms starting 3/13, was admitted to the hospital for respiratory failure on 3/16 and expired on 3/18/21",Yes,03/18/2021,Not Reported,Yes,3.0,Not Reported,N,03/03/2021,03/13/2021,10.0,SEN,unknown BP med,None,"Intellectual disability, hypertension",,None,"['COVID-19', 'COVID-19 pneumonia', 'Chest X-ray abnormal', 'Death', 'Renal failure', 'Respiratory failure', 'SARS-CoV-2 test positive']",1,JANSSEN, 1111726,WA,85.0,F,Patient was reported by adult care home to have passed away 3/12/21,Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,02/25/2021,03/12/2021,15.0,PHM,"acidophilus capsules, losartan, calcium antacid, oxybutynin, donepezil, pantoprazole, diclofenac sodium gel, acetaminophen, vitamin d3. citalopram, cephalexin",Stroke on February 14th,,,no known,['Death'],1,MODERNA,IM 1111924,MT,70.0,F,Patient found demised at home on 3/17/2021,Yes,03/17/2021,Not Reported,Not Reported,,Not Reported,N,03/16/2021,03/17/2021,1.0,PVT,"Prednisone 5mg QDay Folic Acid 1mg Q Day Colace Sodium 100mg BID Hydroxyzine 25mg 2 tabs TID Lactulose 40ml M, W, F Culturelle 1 capsule once daily Mircera 300mg IM once per month Prilosec 20mg once daily Gentamicin topical applied to cathe",ESRD HTN Dyslipidemia Skin Cancer Vitamin B12 Deficiency Osteoporosis,ESRD HTN Dyslipidemia Skin Cancer Vitamin B12 Deficiency Osteoporosis,,"Scallops and clams, anaphylaxis",['Death'],2,MODERNA,IM 1111957,MD,71.0,F,Received vaccine on 3/3/2021 then was found dead in bed by her husband on 3/7/2021.,Yes,03/07/2021,Not Reported,Not Reported,,Not Reported,N,03/03/2021,03/07/2021,4.0,PHM,metformin,unknown,stage 4 kidney disease; peripheral vascular disease; emphysema; GERD; HTN; A-Fib; cardiac disease; current smoker,,unknown,['Death'],1,MODERNA,IM 1112104,,90.0,F,Patient passed away within 60 days of receiving a COVID vaccine,Yes,03/09/2021,Not Reported,Not Reported,,Not Reported,,02/26/2021,03/09/2021,11.0,SEN,,,,,,['Death'],1,MODERNA, 1112117,UT,88.0,M,"Patient was a patient on hospice, had terminal dx of frontal lobe dementia. NP visited with patient on 03/10/2021, notable decline/flank pain, fever 101. Patient passed away on 03/12/21, Medical Director wanted this reported to VAERS d/t the vaccination was within 72hrs of the pts death.",Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,03/09/2021,03/09/2021,0.0,UNK,"Multivitamin, Allergy Med, Vit C, Ativan, B-12, Celexa, Chelated Zinc, cholecalcifefol - Vit D3, Crestor, Furosemide, Haloperidol lactate, Keflex, losartan, mangnesium oxide, morphine concentrate, potassium chloride ER, Promethazine, Seleni","Frontal Lobe Dementia, Muscle Weakness, Edema, weight loss",same as 11.,,no known allergies,"['Death', 'Flank pain', 'General physical health deterioration', 'Pyrexia']",1,PFIZER\BIONTECH,IM 1112122,CA,43.0,M,"Patient was admitted for Multi drug resistant UTI (for which he has been admitted many times before). Was hospitalized for 3 days while awaiting cultures, hemodynamically stable, with no lab abnormalities. On the day of discharge (sensitivities to UTI came back, pt to be discharged on cefepime, had PICC line) pt got up from bed, sat on the edge of the bed and was being given belongings by the nurse, alert and oriented and in a pleasant mood, when suddenly pt grabbed at his chest and stated ""I can't breathe"" and became combative and altered when O2 was attempted to be placed on pt's face; then pt had PEA arrest x3 and unable to achieve ROSC.",Yes,03/15/2021,Not Reported,Not Reported,,Not Reported,N,03/13/2021,03/15/2021,2.0,PVT,"Macrobid 100 mg po BID Cefepime 2g daily (3/12-3/19) Dilaudid 2 mg po PRN pain gabapentin 600 mg BID Methotrexate qFriday Metoprolol 25 mg BID Odefsey (HAART) Mirtazipine daily Glipizide, insulin for DM2",Complicated lower UTI (hospitalized for this- received vaccine in house) - MDR bacteria,Neurosarcoidosis Transverse myelitis with lower paraplegia HIV positive (on HAART) DM2 MDD,,PCN Cipro Ertapenem Fosfomycin,"['Aggression', 'Mood altered', 'Pulmonary embolism', 'Pulseless electrical activity', 'Respiratory arrest', 'Sudden death']",1,JANSSEN,IM 1112123,UT,77.0,M,"This patient was on hospice, we are reporting this to VAERS at the Medical Directors request d/t patient's death within 48 hours of the second dose vaccine. The death occurred the morning following his second dose of the Moderna COVID-19 Vaccination, vaccine received on 03/11/21 and patient date of death 03/12/21 at 9:41 am. This was a hospice patient with a terminal dx of CKD. This is being reported at the request of the Medical Director for the hospice team, d/t the patient's death occurred within 48 hours of receiving the second dose of this vaccine. The nurse case manager stated the pt was declining as they were on hospice for a terminal condition and had co-morbidities, Pt did show more decline after receiving COVID-19 vaccination and patient passed away within 48 hours of receiving second vaccination dose.",Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,03/11/2021,03/12/2021,1.0,PUB,"Aspirin, Vit C, Coreg, Excitalopram, Ferrous Sulfate, Pravastatin, Senna Plus, Torsemide","CKD, muscle weakness, Heart Failure, CAD, Diabetes, HTN, Hyperlipidema, Palliative Care",,,NKA,"['Death', 'General physical health deterioration']",2,MODERNA,IM 1112136,MN,97.0,F,Patient passed away within 60 days of receiving a COVID vaccine,Yes,02/11/2021,Not Reported,Not Reported,,Not Reported,,02/03/2021,02/11/2021,8.0,SEN,,,,,,['Death'],2,MODERNA, 1112164,MN,46.0,M,"lndividual Suddenly passed away on 3/7/21.....His Psychiartrist stated that there could be an adverse effect with COVID, the COVID Vaccination and medications, with an emphasis on Clozapine",Yes,03/07/2021,Not Reported,Not Reported,,Not Reported,N,03/04/2021,03/06/2021,2.0,OTH,Individual was a number of medications. His Psyciatrist wants Clozapine Emphasized CARBAMAZEPINE 200 MG TABLET Carbamazaepine 100mg ER Tab 12h Clozapine FLUTICASONE PROP 50 MCG SPRAY FOLIC ACID 1 MG TABLET Gabapentin 300mg caps Gabapentin,Had COVID November,"299.00 - Autistic disorder, current or active state 307.50 - Eating disorder, unspecified PICA 318.0 - Moderate mental retardation 493.9 - Asthma, unspecified 780.39 - Other convulsions",,Amoxicillan Lactose,['Sudden death'],2,MODERNA,IM 1112185,MN,86.0,F,Patient passed away within 60 days of receiving the COVID vaccine series,Yes,03/04/2021,Not Reported,Not Reported,,Not Reported,,02/04/2021,03/04/2021,28.0,SEN,,,,,,['Death'],2,MODERNA, 1112223,MN,83.0,F,Patient passed away within 60 days of receiving a COVID vaccine,Yes,03/05/2021,Not Reported,Not Reported,,Not Reported,,01/21/2021,03/05/2021,43.0,SEN,,,,,,['Death'],UNK,MODERNA, 1112264,ND,88.0,M,death,Yes,01/22/2021,Not Reported,Not Reported,,Not Reported,,01/21/2021,01/22/2021,1.0,PUB,,,,,,['Death'],UNK,MODERNA,SYR 1112370,NJ,69.0,M,The patient got the Moderna vaccine on 3/2/2021. On 3/3/2021 he suffered a dissection of the ascending thoracic aorta and died.,Yes,03/03/2021,Not Reported,Not Reported,,Not Reported,N,03/02/2021,03/03/2021,1.0,PVT,"Irbesartan 75 mg daily; pravastatin 40 mg daily; famotidine 20 mg twice daily, Saw Palmetto 160 mg daily, Vitamin D3 1000 units daily; clobetasol cream; triamcinolone cream",No acute illnesses,"Hypertension, hypercholesterolemia, thrombocytopenia, obstructive sleep apnea, benign prostatic hypertrophy, multinodular goiter",,Sulfa antibiotics,"['Angiogram', 'Aortic dissection', 'Blood test', 'Computerised tomogram abdomen', 'Death']",1,MODERNA, 1112420,MI,92.0,F,Patient was contacted about coming in to receive second dose and family member had informed us that she had passed away from COVID two weeks after vaccine was given.,Yes,03/04/2021,Not Reported,Not Reported,,Not Reported,N,02/18/2021,03/04/2021,14.0,OTH,,,,,,['Death'],1,MODERNA,IM 1112517,TX,88.0,F,My mother died of a brain hemorrhage 5 days after receiving the vaccine.,Yes,03/08/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/07/2021,2.0,PUB,Lisinopril,mild diabetes,high blood pressure,,shellfish allergy,"['Cerebral haemorrhage', 'Death']",UNK,MODERNA, 1112545,CA,89.0,M,"Information not known to me. Information learned as Dr. provided Complication from COVID Vaccination as Cause of Death on Death Certificate. Decedent died at home and he went to the funeral home. He did not come to Coroner. However, cause of death reported to Coroner and how we learned. I am reporting it but have no particular information specific to vaccination.",Yes,03/10/2021,Not Reported,Not Reported,,Not Reported,N,03/10/2021,03/10/2021,0.0,OTH,Not known,Not known,"Congestive heart failure, triple bypass surgery, diabetes mellitus",,Not known,['Death'],UNK,UNKNOWN MANUFACTURER, 1112579,NJ,42.0,F,Pulmonary embolism resulting in sudden death,Not Reported,,Not Reported,Not Reported,,Not Reported,N,03/03/2021,03/07/2021,4.0,PHM,Mesalamine 1.2 g three times a day,None,Chrons,,Knda,"['Autopsy', 'Pulmonary embolism', 'Sudden death']",1,MODERNA,IM 1112585,AZ,72.0,M,patient diagnosed with covid on 2.18.2021 and died of covid 3.6.2021,Yes,03/06/2021,Not Reported,Not Reported,,Not Reported,N,01/28/2021,02/18/2021,21.0,PHM,zyrtec 10 mg daily generic tylenol 2 bid gas relief 126 mcg prn ducolax as needed pepto as neededvit d3 2000 units 2 qd vit b12 1000 mg 1qd asa 81 mg qd,hbp thyroid copd severe sleep apnea renal failure renal transplant 2016,see above,,,"['COVID-19', 'Death']",1,MODERNA, 1112701,TN,72.0,M,Pt received COVID19 shot on 3/12/2021. Pt passed away on 3/15/2021. Dr called us to inform us that our patient had passed away but he did not believe it was caused by the vaccination at this time.,Yes,03/15/2021,Not Reported,Not Reported,,Not Reported,N,03/12/2021,03/15/2021,3.0,PHM,"warfarin, famotidine",,,,penicillin,['Death'],1,JANSSEN,IM 1112743,FL,85.0,F,PATIENT PASSED AWAY ON 3/14/2021 @ 6:10 PM,Yes,03/14/2021,Not Reported,Not Reported,,Not Reported,N,03/12/2021,03/14/2021,2.0,PHM,UNKNOWN,UNKNOWN,UNKNOWN,,NONE,['Death'],2,MODERNA,IM 1112773,CA,56.0,F,"Moderna #1 vaccine given at 130pm March 11th 2021. Pt had history of asthma and frequent nebulizer use and had it in car with her for drive-thru vaccine clinic we did at location, which has a large parking lot. We gave 80 doses. Pt checked off anaphylaxis on the intake form so Dr spoke to her and she changed it to no history of anaphylaxis and only has history of asthma. So we gave her the vaccine. About 5 minutes later in car parking lot she started to use her personal nebulizer. I saw her in passenger side of car using a personal nebulizer so I talked to her and her daughter to find out what was going on. They said she has exacerbations all the time and this was not out of ordinary for her. I checked pulse ox and did a lung exam, etc, and she was stable. She seemed baseline according to history by her and her daughter. As she seemed at baseline and clinically was comfortable and conversant whole time, and she felt better after her nebulizer, I told them to have a low threshold for going to ER or calling 911 if her asthma was worse or different than her usual symptoms. They agreed. According to daughter, she did well until about 24 hours the next day. The daughter said she was fine and she went to store and when she returned EMTs were intubating patient and apparently the patient used her epipen and called 911 herself. Approximate time of expiration was 230pm on March12th 2021.",Yes,03/12/2021,Not Reported,Not Reported,,Not Reported,N,03/11/2021,03/12/2021,1.0,PVT,"nebulizer with medications (unknown specifics), had O2 at home, had epipen Rx already from past",Asthma with home O2 and regular exacerbations and nebulizer use.,severe chronic asthma with home O2,,"no known specific allergies to us, just history of severe asthma","['Death', 'Endotracheal intubation']",1,MODERNA,IM 1112825,AR,,U,"Received vaccine on afternoon of 3/15/2021 and began experiencing nausea and vomiting, left arm and shoulder pain, fever, body aches, fatigue, and abdominal pain the morning of 3/16/20. He notified the pharmacy that administered the vaccine to him and they told him that some people have those symptoms with it. On 3/16/21 he went to bed around 11:30 PM feeling terrible and was found dead in his bed the next day (3/17/21) with dried blood coming out of his nose and mouth.",Yes,03/17/2021,Not Reported,Not Reported,,Not Reported,N,,,,PHM,,,,,,"['Abdominal pain', 'Arthralgia', 'Death', 'Epistaxis', 'Fatigue', 'Feeling abnormal', 'Mouth haemorrhage', 'Nausea', 'Pain', 'Pain in extremity', 'Pyrexia', 'Vomiting']",1,MODERNA,IM 1113563,HI,70.0,M,"2/25/21 - sore arm, profound fatigue 2/26/21 - chills, fatigue, runny nose (cold-like sx) 2/27/21 - dry throat 3/02/21 - lost voice 3/03/21 - 3/04/21 - chest congestion, difficulty breathing, sounded like water in lungs 3/05/21 - became pale, eyes rolled back, shaking, immobile, caregiver called ambulance, taken to Hospital ER 3/06/21 - death, Hospital dx him with ""pneumonia"" but I believe that hospital medical staff were unaware of his sx following the COVID vaccine #2 shot.",Yes,03/06/2021,Not Reported,Yes,2.0,Not Reported,N,02/24/2021,02/25/2021,1.0,PVT,,,Multiple Systemic Atrophy (MSA-C),,,"['Aphonia', 'Breath sounds abnormal', 'Chills', 'Death', 'Dry throat', 'Dyspnoea', 'Eye movement disorder', 'Fatigue', 'Immobile', 'Nasopharyngitis', 'Pain in extremity', 'Pallor', 'Pneumonia', 'Respiratory tract congestion', 'Rhinorrhoea', 'Tremor']",2,MODERNA,SYR 1113915,LA,77.0,F,"A-fib; difficulty breathing; sleeping on and off; dry heaving, feeling nauseated, not hungry; weak; chills; mild headache; Tired/fatigue; muscle pain on the arm; joint pain; Feeling nauseated; A spontaneous report was received from a consumer concerning a 77-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain. The patient's medical history, as provided by the reporter, included prior COVID-19 infection. It is not clear if the patient had prior A-Fib. No relevant concomitant medications were reported. On 25-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On 25-Jan-2021, patient was feeling fine right after first dose of the Moderna vaccine. On 26-Jan-2021, the patient felt difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain. Lab details was not provided by the reporter. Treatment for the events included rubbing gel. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tired, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.",Not Reported,,Not Reported,Not Reported,,Not Reported,U,01/25/2021,01/26/2021,1.0,UNK,,,Medical History/Concurrent Conditions: COVID-19 (Hospitalized for acute COVID-19),,,"['Arthralgia', 'Asthenia', 'Atrial fibrillation', 'Chills', 'Dyspnoea', 'Fatigue', 'Headache', 'Nausea', 'Pain in extremity', 'Retching', 'Sleep disorder']",1,MODERNA,OT 1113916,NY,85.0,M,"ACUTE LIVER FAILURE; Hepatic enzymes increased; A spontaneous report was received from a health care professional concerning a 85-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed Acute liver failure and hepatic enzymes increased The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not reported. On unknown date in Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot unknown) intramuscularly for prophylaxis of COVID-19 infection. On 27 Feb 2021, the patient was hospitalized for 2-3 days (approximate date of admission on 27 February 2021 and date of discharge on 1 March 2021) . Reason for hospitalization is secondary to acute liver dysfunction with laboratory evidence of elevated liver enzymes. Treatment for the event was not reported. Action taken with mRNA-1273 in response to the event was not applicable The outcome of the event's, reported were considered unknown. .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.",Not Reported,,Not Reported,Yes,3.0,Not Reported,U,02/01/2021,02/27/2021,26.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history),,,"['Acute hepatic failure', 'Hepatic enzyme', 'Hepatic enzyme increased']",2,MODERNA,OT 1113917,FL,88.0,F,"throat closure three weeks after second dose; has lost the ability to swallow.; hernia; A spontaneous report was received from a consumer concerning an 88-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat closure three weeks after second dose/obstruction, hernia, and lost ability to swallow/dyphagia. The patient's medical history included an aortic valve replacement. Concomitant medications were not provided by the reporter. On 13 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 01120A) intramuscularly for prophylaxis of COVID-19 infection. On 10 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection On an unknown date, the patient had lost the ability to swallow. Patient was taken to the ER and ER doctors thought it was a hernia and suggested a surgery. This was three weeks post dose of the vaccine. The reporter reported that the patient was taken to the hospital on 4 Mar 2021. The doctor diagnosed hernia, but they didn't explain the throat closing. They told him to take the patient to a GI doctor. The GI didn't think it was necessary to do a surgery and scheduled a colonoscopy. The reporter disagreed with the colonoscopy because it didn't address the throat swelling. The hospital had put the patient on IV fluids but didn't have a lot of answers. On 8 Mar 2021, the hospital prescribed antibiotics and speech therapy. Treatment activities reported by the reporter included IV fluids, antibiotics, and speech therapy . Action taken with mRNA-1273 in response to the events was not applicable. The outcome of events, obstruction, hernia, and dysphagia were considered unknown.; Reporter's Comments: The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.",Not Reported,,Not Reported,Yes,,Not Reported,U,01/13/2021,02/25/2021,43.0,UNK,,,Medical History/Concurrent Conditions: Aortic valve replacement,,,"['Dysphagia', 'Hernia', 'Obstruction']",1,MODERNA,OT 1113920,PA,83.0,F,"positive COVID-19 test with no symptoms; Asymptomatic COVID-19; Eventually develop arrhythmia; valley fever; chills; night sweats for 1 and half week; rash looked like confetti; low grade temp; I had an irritation in my upper nose; Platelet count was found to be 90/platelet count dropped corrected with in one week; This is a spontaneous report from a contactable consumer, the patient A 83-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on 09Feb2021 (at the age of 83-years-old) as a single dose, for COVID-19 vaccination. The patient medical history includes Atrial Fibrillation. Concomitant medication include Eliquis, Synthroid, Pravastatin, Diltiazem and Dofetilide The patient experienced arrhythmia, valley fever, chills , night sweats, rash looked like confetti, low grade temp, asymptomatic covid-19, had an irritation in my upper nose, platelet count was found to be 90/platelet count dropped corrected with in one week. The clinical course was reported as follows On '04Mar2020' traveled and had an irritation in my upper nose which I later came to understand was caused my asymptomatic COVID-19. Was treated for valley fever with Antifungal med, Eventually developed arrhythmia. Sought treatment at Clinic. Initial diagnosis made at urgent care where platelet count was found to be 90 '1st week in April' 2020 also reported as an event. Treatment was give for Valley Fever. No Treatment was given for Asymptomatic COVID-19 and Platelet count was found to be 90. No hospitalization was involved The patient underwent lab tests that included Platelet count drop/found to be 90 '1st week in April' , Sars-cov-2 test: tested positive on 'last week in March 2020' 'Tested positive for covid 19 in the first quarter of 2020' . The clinical outcome of the event Asymptomatic COVID-19, Drug ineffective, Arrhythmia, chills, night sweats, rash, fever, nasal discomfort were unknown, while Valley fever and Platelet count low was recovered. Consumer inquired if the vaccine might trigger another platelet drop. Did not seem to but second shot next Tuesday 02Mar2021. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.",Not Reported,,Not Reported,Not Reported,,Not Reported,Y,02/09/2021,,,UNK,ELIQUIS; SYNTHROID; PRAVASTATIN; DILTIAZEM; DOFETILIDE,,Medical History/Concurrent Conditions: Atrial fibrillation,,,"['Arrhythmia', 'Asymptomatic COVID-19', 'Chills', 'Coccidioidomycosis', 'Drug ineffective', 'Nasal discomfort', 'Night sweats', 'Platelet count', 'Platelet count decreased', 'Pyrexia', 'Rash', 'SARS-CoV-2 test']",1,PFIZER\BIONTECH, 1113963,MS,59.0,F,"HLH (hemophagocyticlymphohistiocytosis); This is a spontaneous report from a contactable consumer. A 59-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, lot # EL9264) at single dose on 05Feb2021 12:00 for COVID-19 immunisation, administered at hospital. Medical history included type 2 diabetes mellitus. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient received the 1st dose of bnt162b2 (BNT162B2, lot # EL1284) on 15Jan2021 12:00 for COVID-19 immunisation, administered at hospital. No other vaccine in four weeks. The patient experienced hemophagocyticlymphohistiocytosis (HLH) on 15Feb2021 05:30, considered serious as medically significant and fatal. Patient received treatment for the event: etoposide and steroids. COVID was tested post vaccination in 2021, result unknown. The patient died on 15Feb2021. Cause of death was HLH (hemophagocyticlymphohistiocytosis). An autopsy was not performed.; Reported Cause(s) of Death: HLH (hemophagocyticlymphohistiocytosis",Yes,02/15/2021,Not Reported,Not Reported,,Not Reported,N,02/05/2021,02/15/2021,10.0,PVT,,,Medical History/Concurrent Conditions: Type II diabetes mellitus,,,"['Haemophagocytic lymphohistiocytosis', 'SARS-CoV-2 test']",2,PFIZER\BIONTECH, 1115045,AZ,57.0,M,"Death; A spontaneous report was received from a consumer concerning a 57 years old male patient who received mRNA-1273 for prophylaxis of COVID-19 infection and had died (death). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 2 Mar 2021, approximately three hours prior to the onset of the symptoms, the patient received hia second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. It was reported that the patient died three hours after receiving the 2nd dose in the ER. Treatment information was not provided. The cause of death was unknown. Plans for an autopsy were unknown. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event of death was considered as fatal.; Reporter's Comments: This is a case of sudden concerning a 57 year old male who died three hours after receiving the second dose of the vaccine. Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: unknown cause of Death",Yes,03/02/2021,Not Reported,Not Reported,,Not Reported,N,03/02/2021,03/02/2021,0.0,UNK,,,Medical History/Concurrent Conditions: No adverse event (No reported medical history.),,,['Death'],2,MODERNA,OT 1115348,NC,,F,"death; A spontaneous report was received from a HCP concerning about a 86 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and died. The patient's medical history was not reported. Concomitant medications were not reported. On 05 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026A21A) via intramuscular in left deltoid for prophylaxis of COVID-19 infection. On 06 Mar 2021 the patient died next day after vaccination, who left quite well after vaccination from the facility, the reason for death is not known. Treatment information was not provided. Action taken with mRNA-1273 in response to the event is not applicable. The outcomes of all the event is not applicable.; Reporter's Comments: This is a case of death in a 86 years old female patient, with unknown past medical hx or current co morbid conditions and concomitant medications, who died one day after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death",Yes,03/06/2021,Not Reported,Not Reported,,Not Reported,N,03/05/2021,03/06/2021,1.0,UNK,,,"Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: no adverse event, Continue: [UNK], Comment: No medical history reported",,,['Death'],1,MODERNA,OT